Document ID: FDA-2011-N-0921-18558
Agency: fda
Document Type: Rule
Title: Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption
Posted Date: 2015-11-27T05:00Z

[Federal Register Volume 80, Number 228 (Friday, November 27, 2015)]
[Rules and Regulations]
[Pages 74353-74568]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-28159]

[[Page 74353]]

Vol. 80

Friday,

No. 228

November 27, 2015

Part III

Book 2 of 2 Books

Pages 74353-74672

Department of Health and Human Services

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Food and Drug Administration

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21 CFR Parts 11, 16, and 112

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

  Federal Register / Vol. 80 , No. 228 / Friday, November 27, 2015 / 
Rules and Regulations  

[[Page 74354]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 11, 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: Final 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 or we) is establishing science-based minimum 
standards for the safe growing, harvesting, packing, and holding of 
produce, meaning fruits and vegetables grown for human consumption. FDA 
is establishing these standards as part of our implementation of the 
FDA Food Safety and Modernization Act. These standards do 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 is 
eligible for exemption from the requirements of this rule. The rule 
sets 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 the rule to reduce foodborne illness associated 
with the consumption of contaminated produce.

DATES: This rule is effective January 26, 2016. The effective date of 
Sec. Sec.  117.5(k)(2), 117.8, 117.405(c), 117.410(d)(2)(ii), 
117.430(d), and 117.475(c)(13) published September 17, 2015 (80 FR 
55908), is January 26, 2016. The effective date of Sec. Sec.  
507.12(a)(1)(ii), 507.105(c), 507.110(d)(2)(ii), 507.130(d), and 
507.175(c)(13) published September 17, 2015 (80 FR 56170), is January 
26, 2016. See section XXIV of this document for the compliance dates. 
The incorporation by reference of certain publications listed in this 
rule is approved by the Director of the Federal Register as of January 
26, 2016.

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
I. Background
    A. FDA Food Safety Modernization Act
    B. 2013 Proposed Produce Safety Rule
    C. Draft Qualitative Assessment of Risk
    D. Produce Safety Supplemental Notice
    E. List of Federal Register Publications Regarding the Proposed 
Produce Safety Rule
    F. Public Comments
II. Legal Authority
    A. Relevant Statutory Authorities Other Than Section 419 of the 
FD&C Act and Section 105 of FSMA
    B. Legal Authority for Records Requirements
    C. Intrastate Activities
    D. Application of Section 112.2(b)(6) to Entities Other Than 
Covered Farms
III. General Comments on the 2013 Proposed Rule
    A. General Comments
    B. Intentional Adulteration
    C. Registration
    D. Consistency With USDA's National Organic Program
    E. Consideration of Environmental Standards
    F. Product Testing as a Strategy To Control Pathogens
    G. Aquaponic and Hydroponic Operations
IV. Comments on the Regulatory Approach
    A. Commodity-Specific Versus Integrated Approach
    B. Use of Quantitative Metrics
    C. Scientific Support for the Rule
    D. Market Channels
    E. Guidance in Lieu of the Produce Safety Regulation
    F. Existing Industry Guidelines and Certification Programs
    G. Reducing Burden on Small Farms
    H. Estimated Produce Outbreaks and Associated Illnesses
    I. Impact on Traditional Farming Methods
    J. Other Comments
V. Final Qualitative Assessment of Risk
VI. Comments on Non-Biological Hazards
VII. Comments on Farm-Specific Food Safety Plans
VIII. Comments Related to Foreign Farms
IX. Subpart A--Comments on Definitions and General Provisions
    A. Food That Is Covered and That Is Not Covered (Sec. Sec.  
112.1 and 112.2, and Definition of ``Produce'' in Sec.  112.3(c))
    B. Definitions Other Than Small Business, Very Small Business, 
Produce (Sec.  112.3(c))
    C. Small Businesses, Very Small Businesses, and Farms That Are 
Not Covered or Are Eligible for a Qualified Exemption
X. Subpart B--Comments on General Requirements
    A. General Requirement in Sec.  112.11
    B. General Comments About Alternatives in Sec.  112.12
    C. Alternatives for Additional or All Requirements
    D. Additional Clarification
    E. Prior Approval of Alternatives
XI. Subpart C--Comments on Personnel Qualifications and Training
    A. General Comments
    B. Qualification and Training for Personnel Who Handle (Contact) 
Covered Produce or Food-Contact Surfaces (Sec.  112.21)
    C. Training Personnel Who Conduct a Covered Activity (Sec.  
112.22)
    D. Records Related to Personnel Qualifications and Training 
(Sec.  112.30)
XII. Subpart D--Comments on Health and Hygiene
    A. General Comments
    B. Ill or Infected Persons (Sec.  112.31)
    C. Personnel Hygienic Practices (Sec.  112.32)
    D. Visitors (Sec.  112.33)
XIII. Subpart E--Comments on Agricultural Water
    A. General Comments
    B. General Agricultural Water Quality Requirement (Sec.  112.41) 
and Corresponding Corrective Measures (Sec.  112.45(a))
    C. Agricultural Water Sources, Water Distribution Systems, and 
Pooling of Water (Sec.  112.42)
    D. Treatment of Agricultural Water (Sec.  112.43)
    E. Microbial Quality Criterion for Agricultural Water Used for 
Certain Specified Purposes (Sec.  112.44(a)) and Corresponding 
Corrective Measures (Sec.  112.45(a))
    F. Microbial Quality Criteria for Agricultural Water Used for 
Direct Application During Growing Activities of Produce (Other Than 
Sprouts) (Sec.  112.44(b)) and Corresponding Corrective Measures 
(Sec.  112.45(b))
    G. Testing of Agricultural Water (Sec.  112.46)
    H. Sharing of Water Testing Data (Sec.  112.47(a))
    I. Agricultural Water Used During Harvest, Packing, and Holding 
Activities (Sec.  112.48)
    J. Records Related to Agricultural Water (Sec.  112.50)
    K. Compliance Periods Related to Agricultural Water
XIV. Subpart F--Comments on Biological Soil Amendments of Animal 
Origin and Human Waste
    A. General Comments
    B. Determining the Status of a Biological Soil Amendment of 
Animal Origin (Sec.  112.51)
    C. Handling, Conveying, and Storing Biological Soil Amendments 
of Animal Origin (Sec.  112.52)
    D. Prohibitions Regarding Use of Human Waste (Sec.  112.53)
    E. Treatment Processes (Sec.  112.54)
    F. Microbial Standards Applicable to the Treatment Processes in 
Sec.  112.54 (Sec.  112.55)
    G. Application Requirements and Minimum Application Intervals 
(Sec.  112.56)

[[Page 74355]]

    H. Records Related to Biological Soil Amendments of Animal 
Origin (Sec.  112.60)
    I. Other Comments
XV. Subpart I--Comments on Domesticated and Wild Animals
    A. Subpart I and Prevention of Contamination
    B. Limited Scope of Applicability of Subpart I (Sec.  112.81)
    C. Grazing and Working Animals (Sec.  112.83)
    D. Animal Intrusion (Sec.  112.83)
    E. List of ``Animals of Concern''
XVI. Subpart K--Comments on Growing, Harvesting, Packing, and 
Holding Activities
    A. Growing, Harvesting, Packing, or Holding Both Covered and 
Excluded Produce (Sec.  112.111)
    B. Harvesting Covered Produce (Sec.  112.112)
    C. Handling Harvested Covered Produce (Sec.  112.113)
    D. Dropped Covered Produce (Sec.  112.114)
    E. Packaging Covered Produce (Sec.  112.115)
    F. Food-Packing (Including Food Packaging) Material (Sec.  
112.116)
XVII. Subpart L--Comments on Equipment, Tools, Buildings, and 
Sanitation
    A. Types of Buildings That Are Subject to the Requirements of 
Subpart L (Sec.  112.122)
    B. Equipment and Tools (Sec.  112.123)
    C. Instruments and Controls Used To Measure, Regulate, or Record 
(Sec.  112.124)
    D. Equipment Used in the Transport of Covered Produce (Sec.  
112.125)
    E. Buildings (Sec.  112.126)
    F. Toilet Facilities (Sec.  112.129) and Hand-Washing Facilities 
(Sec.  112.130)
    G. Controlling Animal Excreta and Litter From Domesticated 
Animals (Sec.  112.134)
XVIII. Subpart M--Comments on Sprouts
    A. General Comments
    B. Seeds or Beans Used To Grow Sprouts (Sec.  112.142)
    C. Growing, Harvesting, Packing, and Holding Sprouts (Sec.  
112.143)
    D. Testing During Growing, Harvesting, Packing, and Holding 
Sprouts (Sec.  112.144)
    E. Environmental Testing for Listeria Species or L. 
monocytogenes (Sec.  112.145)
    F. Follow-Up Actions for Positive Environmental Testing Results 
(Sec.  112.146)
    G. Collection and Testing of Samples of Spent Sprout irrigation 
Water or Sprouts (Sec.  112.147)
    H. Actions if Spent Sprout Irrigation Water or Sprouts Test 
Positive for a Pathogen (Sec.  112.148)
    I. Records Related to Sprouts (Sec.  112.150)
    J. Compliance Periods for Covered Activities Involving Sprouts
    K. Other Comments
XIX. Subpart N--Comments on Analytical Methods
    A. Responses to Comments
    B. Other Revisions
    C. Incorporation by Reference
XX. Subpart O--Comments on Records
    A. General Comments
    B. General Requirements Applicable to Records Required Under 
Part 112 (Sec.  112.161)
    C. Storage of Records (Sec.  112.162)
    D. Use of Existing Records (Sec.  112.163)
    E. Length of Records Retention (Sec.  112.164)
    F. Acceptable Formats for Records (Sec.  112.165)
    G. Disclosure of Records Submitted to FDA (Sec.  112.167)
XXI. Subpart P--Comments on Variances
    A. Requesting a Variance (Sec. Sec.  112.171 and 112.172)
    B. The Statement of Grounds in a Variance Petition (Sec.  
112.173)
    C. Process for Requesting a Variance (Sec.  112.176)
    D. Permissible Types of Variances (Sec.  112.182)
    E. Other Comments
XXII. Subpart Q--Comments on Compliance and Enforcement
    A. General Comments on Compliance and Enforcement Strategy
    B. FDA Enforcement Decisions
    C. Coordination of Education and Enforcement (Sec.  112.193)
    D. On-Farm Inspections
    E. Third-Party Audits, Inspections, and Other Arrangements
XXIII. Subpart R--Comments on Withdrawal of Qualified Exemption
    A. Circumstances That May Lead FDA To Withdraw a Farm's 
Qualified Exemption (Sec.  112.201)
    B. Contents of an Order To Withdraw a Qualified Exemption (Sec.  
112.203)
    C. Compliance With, or Appeal of, an Order To Withdraw a 
Qualified Exemption (Sec. Sec.  112.204, 112.205, and 112.206)
    D. Procedure for Requesting an Informal Hearing (Sec.  112.207)
    E. Informal Hearing (Sec.  112.208)
    F. Circumstances Related To Reinstatement of a Qualified 
Exemption That Is Withdrawn (Sec.  112.213)
    G. Other Comments
    H. Conforming Amendment to 21 CFR Part 16
XXIV. Comments on Effective and Compliance Dates
    A. Effective and Compliance Dates for Part 112
    B. Effective Dates for Conforming Changes
    C. Effective Date for Certain Provisions in the PCHF Regulation
    D. Effective Date for Certain Provisions in the PCAF Regulation
XXV. Executive Order 13175
XXVI. Economic Analysis of Impacts
XXVII. Analysis of Environmental Impact
XXVIII. Paperwork Reduction Act of 1995
XXIX. Federalism
XXX. References

Executive Summary

    The FDA Food Safety Modernization Act (FSMA) (Pub. L. 111-353) 
requires FDA to conduct a rulemaking to establish science-based minimum 
standards for the safe production and harvesting of those types of 
fruits and vegetables that are raw agricultural commodities (RACs) for 
which we have determined such standards minimize the risk of serious 
adverse health consequences or death. Further, FSMA 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 
Federal Food, Drug, and Cosmetic Act (FD&C Act). FDA published a 
proposed rule entitled, ``Standards for the Growing, Harvesting, 
Packing, and Holding of Produce for Human Consumption,'' which would 
establish science-based minimum standards for the safe growing, 
harvesting, packing, and holding of produce, meaning fruits and 
vegetables grown for human consumption (78 FR 3504, January 16, 2013). 
The comment period for the proposed rule closed on November 22, 2013. 
In response to information we heard at public meetings, and based on a 
preliminary review of written comments submitted to the docket for the 
2013 proposed rule, information available at that time, and our 
subsequent analysis of the proposed provisions in light of such 
information, FDA issued a supplemental notice of proposed rulemaking 
and reopened the comment period to seek public comment on specific 
issues and amended and new proposed provisions (79 FR 58434; September 
29, 2014). The comment period for the supplemental notice of proposed 
rulemaking closed on December 15, 2014. We are now finalizing this rule 
entitled, ``Standards for the Growing, Harvesting, Packing, and Holding 
of Produce for Human Consumption.''
    The final rule focuses on biological hazards related to produce 
growing, harvesting, packing, and holding. We conducted a ``Qualitative 
Assessment of Risk to Public Health from On-Farm Contamination of 
Produce'' and considered the findings of this assessment in finalizing 
this rule. While we acknowledge the potential for non-biological 
(physical or chemical (including radiological)) hazards in produce, we 
are not addressing such hazards in this rule.

Scope of Coverage of the Rule

    The final rule applies to both domestic and imported produce. 
However, as explained in the remainder of this document, the rule 
contains several exemptions and limitations:
    [ssquf] The rule does not apply to certain specified produce 
commodities that are rarely consumed raw.
    [ssquf] The rule also does not apply to produce that is used for 
personal or on-farm consumption, or that is not a RAC.

[[Page 74356]]

    [ssquf] The rule provides an exemption for produce that receives 
commercial processing that adequately reduces the presence of 
microorganisms of public health significance (e.g. via a ``kill step'') 
as long as certain disclosures are made and written assurances are 
received, with appropriate documentation.
    [ssquf] The rule does not cover farms that have an average annual 
value of produce sold during the previous 3-year period of $25,000 or 
less.
    [ssquf] The rule provides 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 
previous 3 years; and (2) the farm's sales to qualified end-users must 
exceed sales to others. A qualified end-user is either: (1) The 
consumer of the food or (2) a restaurant or retail food establishment 
that is located in the same State or the same Indian reservation as the 
farm or not more than 275 miles away. Instead, these farms are 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 to display the 
same information at the point-of-purchase. These farms are also 
required to establish and keep certain documentation. 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.
    The rule also permits States, tribes, or foreign countries to 
submit a petition, along with supporting information, to FDA requesting 
a variance(s) from the requirements of this rule.

Summary of the Major Provisions of the Rule

    The final rule establishes science-based minimum standards for the 
safe growing, harvesting, packing, and holding of produce on farms. 
Based on the findings of the Qualitative Assessment of Risk, we are 
focusing the provisions of this rule on five major routes of 
contamination. We are finalizing requirements in the following major 
areas:
[ssquf] Worker Training and Health and Hygiene
    [cir] Establish qualification and training requirements for all 
personnel who handle (contact) covered produce or food-contact surfaces 
and their supervisors (Sec. Sec.  112.21, 112.22, and 112.23);
    [cir] Require documentation of required training and corrective 
actions (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 (Sec. Sec.  112.31, 
112.32, and 112.33).
[ssquf] Agricultural Water
    [cir] Require that all agricultural water must be safe and of 
adequate sanitary quality for its intended use (Sec.  112.41). 
Agricultural water is defined in part as water that is intended to, or 
is likely to, contact the harvestable portion of covered produce or 
food-contact surfaces (Sec.  112.3(c));
    [cir] Establish requirements for inspection, maintenance, and 
certain other actions related to the use of agricultural water, water 
sources, and water distribution systems associated with growing, 
harvesting, packing, and holding of covered produce (Sec. Sec.  112.42 
and 112.48);
    [cir] If a farm chooses to treat agricultural water to meet 
relevant requirements for its intended use, establish requirements 
related to methods of treatment and monitoring such treatment (Sec.  
112.43);
    [cir] Establish specific requirements for the microbial 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, and treated water), and requiring certain 
actions to be taken when such water is not safe or of adequate sanitary 
quality for its intended use and/or does not meet the microbial quality 
requirements (Sec. Sec.  112.44, 112.45, 112.46, and 112.47); and 
provide for the use of alternative requirements for certain provisions 
under certain conditions (Sec. Sec.  112.12 and 112.49); and
    [cir] Require certain records, including documentation of 
inspection findings, water testing results, scientific data or 
information relied on to support the adequacy of water treatment 
methods, treatment monitoring results, scientific data or information 
relied on to support microbial die-off or removal rates or any 
permitted alternatives to requirements, time intervals or log 
reductions applied, and corrective actions (Sec.  112.50).
[ssquf] 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 (Sec. Sec.  112.51 and 
112.52);
    [cir] Prohibit the use of human waste for growing covered produce 
except in compliance with U.S. Environmental Protection Agency (EPA) 
regulations for such uses or equivalent regulatory requirements (Sec.  
112.53);
    [cir] Establish requirements for treatment of biological soil 
amendments of animal origin with scientifically valid, controlled, 
biological, physical and/or chemical processes that satisfy certain 
specific microbial standards (Sec. Sec.  112.54 and 112.55), including 
examples of such processes;
    [cir] Establish application requirements and minimum application 
intervals for untreated and treated biological soil amendments of 
animal origin (Sec.  112.56); and
    [cir] Require certain records, including documentation from 
suppliers of treated biological soil amendments of animal origin, 
documentation that process controls were achieved, and corrective 
actions (Sec.  112.60).
[ssquf] Domesticated and Wild Animals
    [cir] If there is a reasonable probability that grazing animals, 
working animals, or animal intrusion will contaminate covered produce, 
require measures to assess as needed relevant areas during growing and, 
if significant evidence of potential contamination is found, take 
measures reasonably necessary to assist later during harvest when the 
farm must identify, and not harvest, covered produce that is reasonably 
likely to be contaminated with a known or reasonably foreseeable hazard 
(Sec. Sec.  112.83 and 112.112).
[ssquf] 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 (Sec. Sec.  
112.121-134); and
    [cir] Require certain records related to the date and method of 
cleaning or sanitizing equipment used in growing operations for 
sprouts, and in covered harvesting, packing, or holding activities, and 
corrective actions (Sec.  112.140).

[[Page 74357]]

[ssquf] Sprouts
    [cir] Establish scope of applicability of sprout provisions (Sec.  
112.141);
    [cir] Establish measures that must be taken related to seeds or 
beans for sprouting (Sec.  112.142);
    [cir] Establish measures that must be taken for the growing, 
harvesting, packing, and holding of sprouts (Sec.  112.143);
    [cir] Require testing the growing environment for Listeria species 
(Listeria spp.) or Listeria monocytogenes (L. monocytogenes) and 
testing each production batch of spent sprout irrigation water or 
sprouts for Escherichia coli (E. coli) O157:H7, Salmonella species 
(Salmonella spp.) and, under certain conditions, other pathogen(s), and 
taking appropriate follow-up actions (Sec. Sec.  112.144-112.148); and
    [cir] Require certain records, including documentation of treatment 
of seeds or beans for sprouting, a written environmental monitoring 
plan and sampling plan, test results, certain test methods used, and 
corrective actions (Sec.  112.150).
    The effective date of this rule is 60 days after its publication in 
the Federal Register. As shown in the following table, we are 
establishing three sets of compliance dates, all of which vary based on 
size of the farm: (1) For covered activities involving sprouts subject 
to subpart M, which are also subject to all of part 112 as applicable; 
(2) for covered activities involving all other produce, which are 
subject to all of part 112 as applicable except subpart M; and (3) for 
farms eligible for a qualified exemption and related modified 
requirements. In the second set of compliance dates, we are also 
providing extended compliance dates for certain specified requirements 
related to agricultural water. In the compliance dates relating to the 
qualified exemption, the compliance date for the records that a farm is 
required by Sec.  112.7(b) to maintain to support its eligibility for a 
qualified exemption is the effective date of this rule, i.e., January 
26, 2016. Farms need not comply with the requirement for a written 
record reflecting that the farm has performed an annual review and 
verification of continued eligibility for the qualified exemption until 
the farm's general compliance date, however. In addition, we are 
establishing January 1, 2020, as the compliance date for the modified 
requirement in Sec.  112.6(b)(1).

                                                                                        Compliance Dates
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                 Covered activities involving all other covered produce          Farms eligible for a qualified exemption (if applicable)
                                        Covered activities            (i.e., subject to part 112, except subpart M)      -----------------------------------------------------------------------
                                    involving sprouts covered  ----------------------------------------------------------  Compliance date for
       Size of covered farm           under subpart M (i.e.,                                                              retention of records   Compliance date for    Compliance date for all
                                          subject to all        Compliance date for certain    Compliance date for all         supporting             modified          other  requirements in
                                    requirements of  part 112)     specified  agricultural       other  requirements       eligibility in Sec.   requirement in Sec.    Sec.  Sec.   112.6 and
                                                                    water  requirements                                          112.7(b)            112.6(b)(1)                 112.7
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
                                                 Time periods starting from the effective date of this rule
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Very small business..............  3 years....................  6 years....................  4 years....................  Effective date of     January 1, 2020.....  4 years.
                                                                                                                           rule.
Small business...................  2 years....................  5 years....................  3 years....................                                              3 years.
All other businesses.............  1 year.....................  4 years....................  2 years....................                                              N/A.
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

Costs and Benefits

    The primary benefits of the provisions in this final rule are an 
expected decrease in the incidence of illnesses related to microbial 
contamination of produce. Annualizing benefits over the first ten years 
after the effective date of the rule at seven percent, benefits are 
expected to derive from averting approximately 331,964 illnesses per 
year (362,059 at 3 percent), valued at $925 million annually ($976 
million at 3 percent). Similarly, annualized costs, estimated at 7 
percent, are expected to be approximately $366 million annually ($387 
million at 3 percent). Additionally, annualized costs for foreign farms 
are estimated to be approximately $138 million annualized at 7 percent 
($146 million at 3 percent).

I. Background

A. FDA Food Safety Modernization Act

    The FDA Food Safety Modernization Act (FSMA) (Pub. L. 111-353), 
signed into law by President Obama on January 4, 2011, is intended to 
allow 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 relying primarily on 
reacting to problems after they occur. The law also provides new 
enforcement authorities to help achieve higher rates of compliance with 
risk-based, prevention-oriented safety standards and to better respond 
to and contain problems when they do occur. In addition, the law 
contains important new tools to better ensure the safety of imported 
foods and encourages partnerships with State, local, tribal, and 
territorial authorities. A top priority for FDA are those FSMA-required 
regulations that provide the framework for industry's implementation of 
preventive controls and enhance our ability to oversee their 
implementation for both domestic and imported food. To that end, we 
proposed the seven foundational rules listed in Table 1 and requested 
comments on all aspects of these proposed rules.

    Table 1--Published Foundational Rules for Implementation of FSMA
------------------------------------------------------------------------
              Title                  Abbreviation         Publication
------------------------------------------------------------------------
Standards for the Growing,        2013 proposed       78 FR 3504,
 Harvesting, Packing, and          produce safety      January 16, 2013.
 Holding of Produce for Human      rule or simply
 Consumption.                      ``2013 proposed
                                   rule''.

[[Page 74358]]

 
Current Good Manufacturing        2013 proposed       78 FR 3646,
 Practice and Hazard Analysis      human preventive    January 16, 2013.
 and Risk-Based Preventive         controls rule.
 Controls for Human Food.
Current Good Manufacturing        2013 proposed       78 FR 64736,
 Practice and Hazard Analysis      animal preventive   October 29, 2013.
 and Risk-Based Preventive         controls rule.
 Controls for Food for Animals.
Foreign Supplier Verification     2013 proposed FSVP  78 FR 45730, July
 Programs (FSVP) for Importers     rule.               29, 2013.
 of Food for Humans and Animals.
Accreditation of Third-Party      2013 proposed       78 FR 45782, July
 Auditors/Certification Bodies     third-party         29, 2013.
 to Conduct Food Safety Audits     certification
 and to Issue Certifications.      rule.
Focused Mitigation Strategies To  2013 proposed       78 FR 78014,
 Protect Food Against              intentional         December 24,
 Intentional Adulteration.         adulteration rule.  2013.
Sanitary Transportation of Human  2014 proposed       79 FR 7006,
 and Animal Food.                  sanitary            February 5, 2014.
                                   transportation
                                   rule.
------------------------------------------------------------------------

    We also issued supplemental notices of proposed rulemaking for the 
rules listed in table 2 and requested comments on specific issues 
identified in each supplemental notice of proposed rulemaking.

 Table 2--Published Supplemental Notices of Proposed Rulemaking for the
              Foundational Rules for Implementation of FSMA
------------------------------------------------------------------------
              Title                  Abbreviation         Publication
------------------------------------------------------------------------
Standards for the Growing,        2014 supplemental   79 FR 58434,
 Harvesting, Packing, and          produce safety      September 29,
 Holding of Produce for Human      notice or simply    2014.
 Consumption.                      ``supplemental
                                   notice''.
Current Good Manufacturing        2014 supplemental   79 FR 58524,
 Practice and Hazard Analysis      human preventive    September 29,
 and Risk-Based Preventive         controls notice.    2014.
 Controls for Human Food.
Current Good Manufacturing        2014 supplemental   79 FR 58476,
 Practice and Hazard Analysis      animal preventive   September 29,
 and Risk-Based Preventive         controls notice.    2014.
 Controls for Food for Animals.
Foreign Supplier Verification     2014 supplemental   79 FR 58574,
 Programs (FSVP) for Importers     FSVP notice.        September 29,
 of Food for Humans and Animals.                       2014.
------------------------------------------------------------------------

    As FDA finalizes these seven foundational rulemakings, we are 
putting in place a framework for food safety that is modern and brings 
to bear the most recent science on provisions to enhance food safety, 
that is risk-based and focuses effort where the hazards are reasonably 
likely to occur, and that is flexible and practical given our current 
knowledge of food safety practices. To achieve this, FDA has engaged in 
a great deal of outreach to the stakeholder community to find the right 
balance in these regulations of flexibility and accountability.
    Since FSMA was enacted in 2011, we have been involved in 
approximately 600 engagements on FSMA and the proposed rules, including 
public meetings, webinars, listening sessions, farm tours, and 
extensive presentations and meetings with various stakeholder groups 
(Ref. 1). As a result of this stakeholder dialogue, FDA decided to 
issue the four supplemental notices of proposed rulemaking to share our 
current thinking on key issues and get additional stakeholder input on 
those issues. As we move forward into the next phase of FSMA 
implementation, we intend to continue this dialogue and collaboration 
with our stakeholders, through guidance, education, training, and 
assistance, to ensure that everyone understands and engages in their 
role in food safety. FDA believes these seven foundational final rules, 
when implemented, will fulfill the paradigm shift toward prevention 
that was envisioned in FSMA and be a major step forward for food safety 
that will protect consumers into the future.

B. 2013 Proposed Produce Safety Rule

    Eating fruits and vegetables is an important part of a healthy 
diet. FDA is responsible for ensuring the safety of all domestic and 
imported fruits and vegetables. 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 physical and 
chemical (including 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.
    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 adopt a final 
regulation to provide for minimum science-based standards for fruits 
and vegetables that are RACs based on known safety risks, and directing 
FDA to set forth in the final regulation those 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. On 
January 16, 2013, FDA issued the produce safety proposed rule to 
propose such standards, as well as certain exemptions from the 
standards, consistent with section 419 of the FD&C Act (78 FR 3504; 
hereafter referred to as ``the 2013 proposed produce safety rule'' or 
simply ``the 2013 proposed rule''). Specifically, we proposed, among 
other provisions, to:
    [ssquf] Establish, in 21 Code of Federal Regulations (CFR) proposed 
part 112, science-based minimum standards for the safe growing, 
harvesting, packing, and holding of produce on farms, focusing on the 
areas of worker training and health and hygiene; agricultural water; 
biological soil amendments; domesticated and wild animals;

[[Page 74359]]

equipment, tools, and buildings; and sprouts;
    [ssquf] Focus the rule on microbiological hazards related to 
produce growing, harvesting, packing, and holding;
    [ssquf] Apply proposed part 112 to both domestic and imported 
produce, with several exemptions, including that the rule would not 
apply to certain specified produce commodities that are rarely consumed 
raw; produce that is used for personal or on-farm consumption; or 
produce that is not a RAC;
    [ssquf] Provide an exemption for produce that receives commercial 
processing that adequately reduces the presence of microorganisms 
(e.g., ``kill step'') as long as certain documentation is kept;
    [ssquf] Not cover farms that have an average annual value of food 
sold during the previous 3-year period of $25,000 or less;
    [ssquf] Provide a qualified exemption and modified requirements for 
farms that meet certain requirements, as well as establish 
circumstances and procedures under which this exemption may be 
withdrawn; and
    [ssquf] Require compliance within time periods ranging from 2 to 4 
years based on the size of farm, with an additional 2 years to comply 
with some of the proposed water provisions.
    We extended the comment period for the 2013 proposed produce safety 
rule in response to requests that we do so (78 FR 11611, February 19, 
2013; and 78 FR 24692, April 26, 2013). We later extended the comment 
period to allow interested persons an opportunity to consider the 
interrelationships between the 2013 proposed produce safety rule and 
the 2013 proposed FSVP and third-party certification rules (78 FR 
48637, August 9, 2013). We also issued a notice correcting several 
typographical, stylistic, and reference numbering errors (78 FR 17155, 
March 20, 2013). At the time of that correction notice, we also made 
publicly available, in its entirety, the proposed produce safety rule 
with all errors corrected. The comment period for the 2013 proposed 
rule closed on November 22, 2013.

C. Draft Qualitative Assessment of Risk

    We conducted a ``Draft Qualitative Assessment of Risk to Public 
health from On-Farm Contamination of Produce'' (hereafter referred to 
as ``the draft QAR'') to evaluate hazards related to produce production 
and harvesting. We published the findings of our assessment, and asked 
for public comment on our assessment and findings (78 FR 3504, January 
16, 2013). The tentative conclusions of this assessment informed our 
proposed science-based minimum standards for the safe production and 
harvesting of produce commodities.

D. Produce Safety Supplemental Notice

    Taking into account information we heard at public meetings, and 
based on a preliminary review of written comments submitted to the 
docket, then-currently available information, and our subsequent 
analysis of the proposed provisions in light of this information, on 
September 29, 2014, we proposed certain new provisions and certain 
amendments to our provisions proposed in the 2013 proposed rule (79 FR 
58434; hereafter referred to as ``the 2014 supplemental produce safety 
notice'' or simply ``the supplemental notice''). Specifically, we 
proposed among other provisions:
    [ssquf] Amendment to not cover farms that have an average annual 
value of produce sold during the previous three year period of $25,000 
or less;
    [ssquf] Amendment to the definition of ``farm'' such that 
establishments that pack or hold produce that is grown or harvested on 
another farm would be subject to the produce safety standards of 
proposed part 112 regardless of whether or not that farm is under the 
same ownership;
    [ssquf] Amendments to update the microbial quality standard for 
water that is used during growing of produce (other than sprouts) using 
a direct application method; and to incorporate additional flexibility 
and provide means to achieve this standard, i.e., by applying a time 
interval between last irrigation and harvest and/or between harvest and 
end of storage to account for post-application microbial die-off or 
removal;
    [ssquf] Amendment to provide tiered-approaches for specific testing 
frequency requirements to test untreated surface water as well as 
untreated ground water, which would enable testing at a reduced 
frequency;
    [ssquf] Amendment to remove the 9-month minimum application 
interval for use of raw manure and other untreated biological soil 
amendments of animal origin, and defer FDA's decision on an appropriate 
time interval until FDA takes certain specified actions;
    [ssquf] New provision to explicitly state that part 112 would not 
authorize or require covered farms to take actions that would 
constitute the ``taking'' of threatened or endangered species in 
violation of the Endangered Species Act (ESA), or require covered farms 
to take measures to exclude animals from outdoor growing areas, or 
destroy animal habitat or otherwise clear farm borders around outdoor 
growing areas or drainages; and
    [ssquf] New provisions to establish that, before FDA issues an 
order to withdraw a qualified exemption, FDA may consider one or more 
other actions to protect the public health and prevent or mitigate a 
foodborne illness outbreak; and to list the circumstances under which 
FDA would reinstate a farm's qualified exemption that is withdrawn.
    In the 2014 supplemental produce safety notice, we reopened the 
comment period only with respect to the specific issues covered in the 
supplemental notice. In addition, we emphasized that the new and 
amended proposed provisions we included in the regulatory text were 
based on a preliminary review of the comments. We also noted the 2013 
proposed produce safety rule and the new and amended proposed 
provisions published in the 2014 supplemental produce safety notice, 
taken together, constitute the entirety of the proposed rule on 
``Standards for the Growing, Harvesting, Packing, and Holding of 
Produce for Human Consumption.'' The comment period for the 
supplemental notice closed on December 15, 2014.
    In this document, we use the broad term ``proposed produce safety 
rule'' to refer to the complete proposed regulatory text, including 
both the proposed provisions we published in the 2013 proposed produce 
safety rule and the new and amended proposed provisions we published in 
the 2014 supplemental produce safety notice.

E. List of Federal Register Publications Regarding the Proposed Produce 
Safety Rule

    Table 3 lists Federal Register publications regarding the proposed 
produce safety rule. This list does not include the Federal Register 
publications regarding the Environmental Impact Statement (EIS) related 
to this rule; the EIS and related publications are addressed in section 
XXVII of this document.

[[Page 74360]]

  Table 3--List of Federal Register Publications Regarding the Proposed
                           Produce Safety Rule
------------------------------------------------------------------------
                Description                          Publication
------------------------------------------------------------------------
2013 proposed produce safety rule,           78 FR 3504, January 16,
 requesting comments by May 16, 2013.         2013.
Notice of public meeting (held in            78 FR 6762, January 31,
 Washington D.C. on February 28, 2013) on     2013.
 the 2013 proposed preventive controls rule
 and the 2013 proposed produce safety rule.
Notice of public meetings (held in Chicago,  78 FR 10107, February 13,
 IL on March 11, 2013 and in Portland, OR     2013.
 on March 27, 2013) on the 2013 proposed
 preventive controls rule and the 2013
 proposed produce safety rule.
Notice extending comment period, until May   78 FR 11611, February 19,
 16, 2013, for the information collection     2013.
 provisions of the 2013 proposed produce
 safety rule.
Notice of correction for the 2013 proposed   78 FR 17155, March 20,
 produce safety rule.                         2013.
Notice extending the comment period, until   78 FR 24692, April 26,
 September 16, 2013, for the 2013 proposed    2013.
 produce safety rule and its information
 collection provisions.
Notice extending the comment period, until   78 FR 48637, August 9,
 November 15, 2013, for the 2013 proposed     2013.
 produce safety rule and its information
 collection provisions.
Notice extending the comment period, until   78 FR 69605, November 20,
 November 22, 2013, for the 2013 proposed     2013.
 produce safety rule and its information
 collection provisions.
Produce safety supplemental notice,          79 FR 58434, September 29,
 requesting comments by December 15, 2014.    2014.
Notice of public meeting (held in College    79 FR 63346, October 23,
 Park, MD on November 13, 2014) on the        2014.
 human preventive controls supplemental
 notice, produce safety supplemental
 notice, animal preventive controls
 supplemental notice, and FSVP supplemental
 notice.
------------------------------------------------------------------------

F. Public Comments

    Since issuing the 2013 proposed rule, we conducted numerous 
outreach activities. For example, we held four public meetings to 
solicit oral stakeholder and public comments on the 2013 proposed rule 
and the supplemental notice, inform the public about the rulemaking 
process (including how to submit comments, data, and other information 
to the rulemaking dockets), and respond to questions about the 2013 
proposed rule and the supplemental notice (see Table 3) (Ref. 2) (Ref. 
3) (Ref. 4) (Ref. 5) (Ref. 6) (Ref. 7). We also traveled across the 
country and around the world to discuss the 2013 proposed rule, as well 
as the other foundational FSMA proposed rules listed in section I.A of 
this document, with persons who would be affected by them (Ref. 8) 
(Ref. 9) (Ref. 10) .
    We received a total of about 36,000 submissions (representing 
approximately 15,000 unique comments) on the proposed produce safety 
rule by the close of the comment period, each containing one or more 
comments. We received submissions from diverse members of the public, 
including produce farms; facilities co-located on a farm; cooperatives; 
coalitions; trade organizations; consulting firms; law firms; academia; 
public health organizations; public advocacy groups; consumers; 
consumer groups; Congress; federal, State, local, and tribal government 
agencies; and other organizations. Some submissions included signatures 
and statements from multiple individuals. Comments addressed virtually 
every provision of the proposed produce safety rule, including our 
requests for comment on various topics.
    In sections III through XXIV of this document, we describe these 
comments, respond to them, and explain any changes we made to the 
proposed produce safety rule. We discuss comments that ask us to 
clarify the proposed requirements or that disagree with, or suggest one 
or more changes to, the proposed requirements. Our responses to the 
comments include our reasons for determining whether to modify any of 
the proposed requirements. The remainder of this document establishes a 
final rule (``the final rule,'' this final rule,'' ``the rule,'' or 
``this rule'') based on the proposed produce safety rule.
    Some comments address issues that are outside of the scope of this 
rule. We do not discuss such comments in this document. We also 
received comments that solely address topics, such as preventive 
controls applicable to food for humans or animals, traceability, 
foreign supplier verification programs, and third-party accreditation 
or certification, which are outside of the scope of this final produce 
safety rule, and will be appropriately addressed in other relevant FSMA 
rulemaking documents.

II. Legal Authority

    The 2013 proposed rule contained an explanation of its legal basis 
under authorities in FSMA, the FD&C Act, and the Public Health Service 
Act (PHS Act). After considering comments received in response to the 
2013 proposed rule and supplemental notice, FDA made changes in the 
final rule. The legal authorities relied on for the final rule are the 
same as in the 2013 proposed rule unless otherwise described in the 
paragraphs that follow.

A. Relevant Statutory Authorities Other Than Section 419 of the FD&C 
Act and Section 105 of FSMA

    The final rule requires that, to rely on the exemption in Sec.  
112.2(b) for produce that receives commercial processing that 
adequately reduces the presence of microorganisms of public health 
concern, a covered farm must disclose in documents accompanying the 
produce that the food is ``not processed to adequately reduce the 
presence of microorganisms of public health significance'' (Sec.  
112.2(b)(2)). This requirement is authorized by sections 419 and 701(a) 
of the FD&C Act (21 U.S.C. 371(a)).
    Section 112.2(b) exempts from most requirements in the rule produce 
that is low risk because it receives commercial processing that will 
adequately reduce the biological hazards that are the focus of this 
rule. It is important to ensure that such produce does indeed receive 
such commercial processing because such processing is the reason the 
produce is considered sufficiently low risk to be exempt from the other 
requirements in this rule. A food may pass through multiple entities in 
the distribution chain before the control is applied. Further, it may 
not be apparent from visual examination of the food whether a control 
has been applied. Consequently, without labeling, an entity in the 
distribution chain might not know whether a control has been applied. 
Therefore, FDA concludes that information that food has not been 
processed to adequately reduce the presence of microorganisms of public 
health significance must be provided in accompanying documentation when 
a farm is relying on this exemption from the rule. FDA also concludes 
that such labeling is necessary for the efficient

[[Page 74361]]

enforcement of the FD&C Act to help ensure that food receives the 
required processing. Further, because the relevant hazards can cause 
communicable disease, FDA concludes that the requirement is necessary 
to prevent the spread of communicable disease from one State into 
another State and relies on sections 311, 361, and 368 of the PHS Act 
(42 U.S.C. 243, 264, and 271).

B. Legal Authority for Records Requirements

    We are using our authority under the FD&C Act and the PHS Act to 
institute certain records requirements. In addition to those 
requirements we proposed in the 2013 proposed rule and the supplemental 
notice, we are adding the following new record requirement: For farms 
eligible for a qualified exemption and modified requirements, adequate 
records necessary to demonstrate that you satisfy the criteria for a 
qualified exemption, including a written record reflecting that you 
performed an annual review and verification of your farm's continued 
eligibility for the qualified exemption (Sec.  112.7).
    We have also revised some of the records requirements in our 2013 
proposed rule and the supplemental notice. We note in particular that 
the record requirement proposed as Sec.  112.161(b) relating to 
documentation of corrective actions taken under subparts C, E, F, L, 
and M is now eliminated and, instead, we added specific provisions in 
two relevant subparts (E and M), at Sec. Sec.  112.50(b)(6) and 
112.150(b)(6). Moreover, in Sec.  112.50(b)(6), we are also 
establishing specific requirements for documentation of any time 
interval or (calculated) log reduction applied in accordance with Sec.  
112.45(b)(1)(i) and/or (b)(1)(ii), including the specific time interval 
or log reduction applied, how the time interval or log reduction was 
determined, and the dates of corresponding activities such as the dates 
of last irrigation and harvest, the dates of harvest and end of 
storage, and/or the dates of activities such as commercial washing.
    In addition, we note that the revised records requirements in Sec.  
112.2(b) include: (1) For farms relying on the exemption in Sec.  
112.2(b), documentation of disclosures required under Sec.  112.2(b)(2) 
and annual written assurances obtained from customers under Sec.  
112.2(b)(3) (Sec.  112.2(b)(4)); and (2) For entities that provide a 
written assurance under Sec.  112.2(b)(3), documenting actions taken to 
satisfy the written assurance (Sec.  112.2(b)(6)).
    As discussed further in the 2013 proposed rule and in sections XI, 
XIII, XIV, XVII, and XVIII of this document, these records requirements 
are necessary for regulated industry to ensure their own compliance 
with these aspects of the rule and for FDA to ensure that industry is 
complying with the same aspects of the rule. Therefore, these 
requirements are necessary for the efficient enforcement of the FD&C 
Act because they will aid both regulated industry and FDA in ensuring 
that food is not adulterated, and are necessary to prevent the spread 
of communicable disease because they will aid both regulated industry 
and FDA in ensuring that food does not 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 
regulated industry 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 conclude 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 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.

C. Intrastate Activities

    (Comment 1) One comment argues that FDA should not apply this rule 
to activities that are intrastate in character, citing the lack of an 
explicit reference to intrastate activities in relevant sections of the 
FD&C Act, and asserting that the greatest risk of foodborne illness 
comes from food in interstate distribution networks. This comment 
argues that the rule as applied to intrastate commerce is beyond the 
federal government's power under the commerce clause of the 
Constitution.
    (Response) FDA disagrees. We conclude that the 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 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 their constitutionality. (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 laws, 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

[[Page 74362]]

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 concludes that such farms 
should be subject to the rule unless an exemption from the rule applies 
(for example, if the farm is eligible for the qualified exemption in 
Sec.  112.5, or if the farm only grows produce exempt from the 
regulation under one of the exemptions in Sec.  112.2). This outcome 
regarding intrastate commerce is consistent with section 709 of the 
FD&C Act (21 U.S.C. 379a), which states that in any action to enforce 
the FD&C 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 significant, whether or not the food moves from one state 
to another.

D. Application of Section 112.2(b)(6) to Entities Other Than Covered 
Farms

    As discussed in IX.A.4 of this document, we are specifying in Sec.  
112.2(b)(6) that the entities that provide written assurances described 
in Sec.  112.2(b)(3) must act consistently with the assurances and 
document the actions taken to satisfy the assurance. Section 
112.2(b)(6) applies not just to covered farms, but to other entities 
that voluntarily agree to provide the written assurances described in 
Sec.  112.2(b)(3). The application of this requirement to facilities 
subject to section 418 of the FD&C Act is consistent with section 
419(h) of the FD&C Act. Providing, complying with, and documenting 
compliance with the written assurances described in Sec.  112.2(b)(3) 
are not activities that are subject to section 418 of the FD&C Act. As 
discussed in section II.A of this document, in addition to sections 419 
and 701(a) of the FD&C Act, this requirement is supported by sections 
311, 361, and 368 of the PHS Act.

III. General Comments on the 2013 Proposed Rule

A. General Comments

    (Comment 2) Some comments ask us to make the various rules we are 
establishing to implement FSMA consistent with each other.
    (Response) We have aligned the provisions of the various rules to 
the extent practicable. For example, we use the same definitions of 
``farm'' and the terms used in the definition of ``farm'' (i.e., 
harvesting, packing, holding, and manufacturing/processing) in this 
rule, the final human preventive controls rule (80 FR 55908; Ref. 11) 
that established part 117 (the Current Good Manufacturing Practice and 
Hazard Analysis and Risk-Based Preventive Controls for Human Food 
regulation; hereafter referred to as ``the PCHF regulation''), and the 
final animal preventive controls rule (80 FR 56170) that established 
part 507 (the Current Good Manufacturing Practice and Hazard Analysis 
and Risk-Based Preventive Controls for Food for Animals regulation; 
hereafter referred to as ``the PCAF regulation''). However, the 
statutory requirements are not the same for all the rules, and the 
purposes and contents of the rules differ from each other. For example, 
section 419(f) of the FD&C Act (which relates to this rule) and section 
418(l) of the FD&C Act (which relates to the final human preventive 
controls rule) both create qualified exemptions with modified 
requirements for certain entities based in part on business size and/or 
certain specific sales criteria. However, these two sections provide 
different criteria for eligibility for exemption from the two rules, 
and different modified requirements for farms and facilities eligible 
for the relevant exemptions.
    (Comment 3) Several comments ask us to develop guidance to 
accompany this rule to help covered farms to understand and implement 
this rule, particularly in the areas of agricultural water, personnel 
training, domesticated and wild animals, sprout production, and 
biological soil amendments of animal origin. Some of these comments 
also ask that drafts of such guidance first be made available for 
public comment. Comments ask us to take into consideration existing 
public and private food safety programs as we develop our guidance. 
Comments also recommend that guidance documents should be easily 
understood, available in multiple formats (including simple 
checklists), and issued in a timely manner.
    Other comments emphasize the importance of education and outreach 
and ask us to provide support for ongoing education and outreach, 
including taking an active role in providing needed instructional 
examples and lessons learned from current investigations and foodborne 
outbreaks.
    (Response) We are developing guidance documents, including general 
guidance on the implementation of this rule, as well as a Small Entity 
Compliance Guide (SECG) in accordance with section 105(b) of FSMA (21 
U.S.C. 350h note) and section 212 of the Small Business Regulatory 
Enforcement Fairness Act (Pub. L. 104-121). A SECG is a guidance that 
explains the actions a small entity must take to comply with a rule. We 
also intend to develop guidance specific to commodities, as needed. We 
agree that we should take into consideration existing public and 
private food safety programs as we develop our recommendations. We will 
develop and issue our guidances in accordance with our good guidance 
practices regulation, 21 CFR 10.115, which establishes criteria for 
when we issue a guidance document as an initial draft, invite public 
comment, and prepare a final version of the guidance document that 
incorporates suggested changes, when appropriate. The public may submit 
comments on any guidance document at any time (Sec.  10.115(g)(5)).
    We agree with comments that stress the importance of education and 
outreach. Supporting efforts to help covered farms get the education 
and technical assistance they need to understand and implement the 
requirements is a central element of FDA's strategy to gain compliance 
with this rule (Ref. 12) (Ref. 13). Within FDA, we are establishing a 
Food Safety Technical Assistance Network and seeking funding to 
increase FDA staffing to provide a central source of information to 
support industry understanding and implementation of FSMA standards 
(Ref. 12). This will allow us to respond in a timely and consistent way 
to questions from covered farms related to this rule.
    We continue to work with other government agencies, academia, and 
industry groups, as appropriate, to facilitate the successful 
implementation of this rule. For example, FDA, in collaboration with 
the Agricultural Marketing Service (AMS) of the United States 
Department of Agriculture (USDA) and others, has established the 
Produce Safety Alliance (PSA). FDA and others also established the 
Sprouts Safety Alliance (SSA). Both PSA and SSA will develop and 
disseminate science- and risk-based training and education programs to 
provide produce farms with fundamental, on-farm food safety knowledge 
and equip them to comply with the produce safety regulation. FDA is 
working to ensure

[[Page 74363]]

that the PSA and SSA training materials (which we refer to collectively 
as ``the Alliance courses'') are consistent with the requirements of 
this rule.
    We are also partnering with USDA's National Institute of Food and 
Agriculture (NIFA). FDA and NIFA are funding a grant program that will 
provide funding for food safety training, education and technical 
assistance to small farm owners and food processors to help them comply 
with food safety standards to be established under FSMA. The purpose of 
the grant program is to train owners and operators of small businesses, 
including small- and medium-sized farms, beginning farmers, socially 
disadvantaged farmers, small processors, or small fresh fruit and 
vegetable merchant wholesalers, and farms that lack access to food 
safety training and other educational opportunities.
    We also plan to work with cooperative extension units, land grant 
universities, trade associations, foreign partners, the Joint Institute 
for Food Safety and Applied Nutrition (JIFSAN), 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 has entered into a cooperative agreement with National 
Association of State Departments of Agriculture (NASDA) to help with 
the implementation of the produce safety regulation. Such efforts will 
help ensure widespread compliance.
    (Comment 4) Some comments ask us to establish and annually convene 
a scientific workgroup that includes experts in produce production, 
public health, and testing and laboratory science to advise us on 
pathogens that should be addressed in produce safety standards. Some 
other comments recommend that FDA establish a national advisory 
committee or a stakeholder advisory committee to provide ongoing input 
to FDA as FSMA implementation begins, and suggests that such committee 
include members from States, industry, and other stakeholders, as well 
as NASDA. These comments recommend that such advisory body should 
assist FDA in updating regulations or guidance as science evolves and 
new information becomes available. One commenter also believes such an 
established advisory body could function in a manner similar to the 
National Conference on Interstate Milk Shipments or the Interstate 
Shellfish Sanitation Conference and provide a formal and effective 
mechanism for dialogue between FDA, States, NASDA, and the regulated 
community.
    (Response) We disagree with the suggestion to establish an advisory 
group for the purpose of assisting FDA in updating regulations or 
guidance as science evolves and new information becomes available. 
FDA's rulemaking and guidance development processes allow for future 
amendments, and also provide ample opportunity for public input when 
warranted. We will consider the need for such amendments in light of 
evolving scientific information and, as warranted, take appropriate 
actions.
    (Comment 5) Some comments express the need for FDA to review and 
update the provisions in the produce safety regulation as new 
scientific information becomes available. One commenter requests that 
FDA establish a process for such review and update.
    (Response) FDA may, on its own initiative or in response to a 
petition from an interested person, initiate administrative proceedings 
to amend existing regulations, including the produce safety regulation. 
See 21 CFR part 10 for our administrative practices and procedures.
    (Comment 6) Some comments assert that the rule should be more 
concise, and that the average person without a team of experts should 
be able to understand the rule and manage the application of the rule.
    (Response) We agree the rule needs to be understandable. We have 
incorporated plain language techniques--e.g., by framing the regulation 
in the form of questions and answers, and using active voice in the 
requirements. We also have established definitions that enable us to 
improve readability (e.g., ``monitor,'' ``raw agricultural commodity,'' 
and ``you''). We have used examples in the codified, where appropriate, 
and provided examples throughout the preamble to assist with 
understanding the requirements. We will be issuing guidance documents 
that will be helpful in understanding the rule (See Comment 3). We 
anticipate that these various educational and outreach efforts will 
involve development of checklists, templates, protocols, and other 
tools that will facilitate compliance with the produce safety 
regulation.
    (Comment 7) Some comments assert that the rule incorrectly assumes 
that all bacteria are harmful.
    (Response) We have long recognized that some bacteria have a role 
in food production, such as the lactic-acid producing bacteria that our 
regulations explicitly acknowledge as being added to yogurt (see e.g., 
the standards of identity for yogurt, low fat yogurt, and nonfat 
yogurt, in 21 CFR 131.200, 131.203, and 131.206, respectively). This 
rule defines the term ``microorganism,'' which explains that the term 
``undesirable microorganism'' 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 produce safety standards established 
in this rule focus on minimizing the risk of contamination of produce 
with microorganisms that can cause serious adverse health consequences 
or death, and are consistent with our ``Guide to Minimize Microbial 
Food Safety Hazards for Fresh Fruits and Vegetables'' (the GAPs Guide) 
(Ref. 14).
    (Comment 8) One comment suggests covering school-garden programs 
under the produce safety regulation. According to this comment, the 
current requirements for food safety assurance at these farms are 
variable, and practices such as improper manure or compost use could 
present a significant risk to high-risk consumers served by such farms.
    (Response) We expect most school-garden programs would likely fall 
below the monetary threshold for coverage in Sec.  112.4 and, 
therefore, would not be subject to this rule. We have determined the 
scope and coverage of this rule to establish only those requirements 
that are reasonably necessary to meet the public health objectives of 
the regulation. Note, however, that farms that are not subject to this 
rule are and will continue to be covered under the adulteration and 
other applicable provisions of the FD&C Act and applicable implementing 
regulations, irrespective of whether they are included within the scope 
of this rule. We recommend that farms that are not covered under part 
112 follow good agricultural practices to ensure that the produce they 
grow, harvest, pack or hold does not serve as a vehicle for foodborne 
illness.
    (Comment 9) Some comments express concern that current tests for 
pathogens such as E. coli and Salmonella are expensive and time-
consuming, and could lead to holding up perishable produce in the food 
chain. Comments also highlight the need for affordable, on-site, and 
fast test methods, particularly for testing agricultural water.
    (Response) We are not requiring final product testing of produce, 
except as in subpart M under certain circumstances for sprouts, for 
reasons explained in section III.F of this document. In prescribing 
certain analytical methods

[[Page 74364]]

for testing the quality of agricultural water, for testing the growing 
environment of sprouts for Listeria spp. or L. monocytogenes, and for 
testing spent sprout irrigation water (or sprouts) for certain 
pathogens (in subpart N of part 112), we also provided flexibility for 
covered farms to use any other method that is at least equivalent to 
the prescribed analytical methods in accuracy, precision, and 
sensitivity in detecting the relevant organism. We are aware that there 
are numerous scientific testing and diagnostic development companies 
that have invented rapid tests and systems, and that many of these 
products undergo internal quality control and performance testing, as 
well as receive additional third-party approvals. In addition, we are 
aware of programs such as the AOAC International Research Institute's 
Performance Tested Methods Program that provides an independent third-
party review of proprietary test method performance, and that test 
methods demonstrated to meet acceptable performance criteria are 
granted Performance Tested Methods (PTM) status. Such methods, 
including test kit methods, may be acceptable for testing for generic 
E. coli in agricultural water to satisfy the requirements of Sec.  
112.46, for testing for Listeria spp. or L. monocytogenes to satisfy 
the requirements of Sec.  112.144(a), and for testing for certain 
pathogens to satisfy the requirements of Sec.  112.144(b) and (c), 
provided they meet certain conditions in accordance with Sec. Sec.  
112.151(b), 112.152(b), and 112.153(a)(2) and (b), respectively. FDA 
will consider providing guidance on testing methods, specifically on 
rapid and low-cost test kits that might be useful for farms.
    (Comment 10) Some comments ask us to address model laboratory 
standards and accreditation to ensure that laboratories are using sound 
and reliable test methods and practices for detecting and identifying 
microorganisms of public health significance. These comments argue that 
if there are no criteria for training and appropriate use of testing 
devices or interpretation, test results may not be reliable. These 
comments also suggest posting a list of accredited laboratories on 
FDA's Web site for use by farms.
    (Response) We are currently working on a proposed rule to implement 
section 202 of FSMA (section 422 of the FD&C Act), which addresses 
``Laboratory Accreditation for Analyses of Foods.'' Neither model 
laboratory standards nor laboratory accreditation are within the scope 
of the produce safety regulation in part 112.
    (Comment 11) In the 2013 proposed rule, we requested 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 (78 FR 3504 at 3619). Some comments 
respond by noting that not all produce operations will be vulnerable to 
harborage and contamination by pathogens such as L. monocytogenes. 
These comments argue that mandatory environmental monitoring for such 
operations would not yield a food safety benefit and, instead, would 
impose a wasteful economic burden. These comments recommend that 
environmental monitoring or assessment for produce (other than sprouts) 
should be addressed in guidance and can be a part of food safety plans 
for operations vulnerable to relevant routes of contamination. On the 
other hand, some comments, suggest the environmental monitoring 
requirements we proposed for sprouts should be expanded to other high-
risk produce.
    (Response) We are not requiring environmental testing for L. 
monocytogenes or Listeria spp. for covered produce other than sprouts. 
See discussion in the 2013 proposed rule (78 FR 3504 at 3619). Farms 
may consider voluntarily performing environmental testing for L. 
monocytogenes or Listeria spp. as appropriate for their operations. See 
also section VII of this document where we discuss farm-specific food 
safety plans.

B. Intentional Adulteration

    (Comment 12) Several comments address intentional adulteration of 
produce. One comment contends that small farms are inherently more 
resilient to terrorism or other forms of intentionally introduced 
hazards than large farms due to their diversity, independence, and 
geographic decentralization. According to the comment, if the proposed 
produce safety rule negatively affects the viability of diverse small 
farms, in favor of large, centralized farms, then the net result may be 
an increase in the American food system's vulnerability to terrorism. 
With regards to economically motivated intentional adulteration, one 
comment states that this type of adulteration is difficult to prevent 
and should not be addressed in this rule.
    (Response) FDA is implementing the intentional adulteration 
provisions in sections 418, 419, and 420 of the FD&C Act in a separate 
rulemaking. As such, neither intentional adulteration nor economically 
motivated adulteration in the context of fruits and vegetables that are 
RACs, during activities that occur on produce farms, are within the 
scope of the produce safety regulation in part 112. On December 24, 
2013, FDA published a proposed rule to implement the intentional 
adulteration provisions for facilities that manufacture, process, pack, 
or hold food and are required to register under section 415 of the FD&C 
Act (per section 418 of the FD&C Act); for fruits and vegetables that 
are RACs (per section 419 of the FD&C Act); and for high risk foods, 
exempting farms except for farms that produce milk (per section 420 of 
the FD&C Act) (78 FR 78014).

C. Registration

    In the 2013 proposed produce safety rule, we requested comment on 
whether we should require that covered farms, as described in proposed 
Sec.  112.4(a), register with FDA. We acknowledged that 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 the produce safety regulation, 
which, in turn, would enable us to better provide outreach and 
technical assistance to covered entities and to allocate our inspection 
resources. We also requested information about the existence of 
databases that could help us identify covered farms in the absence of a 
registration system, and the appropriate data elements that should be 
collected in a registration system, should we decide to set up such a 
system.
    (Comment 13) Several comments support requiring registration of 
covered farms with FDA, and state that registration would be most 
helpful during response activities associated with illness outbreaks 
and recalls. These comments contend that any registration requirement 
should be kept simple, occur once annually, and apply to every farm no 
matter their size, sales volume, or method of trade. According to these 
comments, registration would provide FDA with key information to 
monitor each crop industry by knowing the size and scope of the 
regulated community, with a secondary advantage for that crop's 
association/board to be able to conduct industry outreach and education 
to assist with compliance with the final rule. Conversely, several 
other comments oppose a requirement for farms to register with FDA, 
stating that such a requirement would be unreasonable and inconsistent 
with FSMA. These comments argue that

[[Page 74365]]

FSMA does not authorize FDA to require farms to register with FDA, and 
that FDA fails to establish how requiring farms to register would 
contribute to improved food safety outcomes in produce production. 
Other comments suggest that FDA has many State and federal partners to 
assist in reaching out to the produce production community, and that 
there are existing industry resources, which include lists of 
producers. Some comments state that local and State agencies or 
extension agencies, not FDA, should maintain a database of farms. Still 
other comments argue that registration would be economically burdensome 
for farmers.
    (Response) At this time, we are not establishing a requirement for 
farms to register with FDA. However, we believe that an inventory of 
farms would enable us to better provide outreach and technical 
assistance to covered farms and to allocate our inspection resources, 
so we intend to pursue other avenues for identifying farms. 
Historically, when we have needed a list of farms, such as for field 
assignments involving inspections, or for conducting education and 
outreach activities, FDA has worked with our district offices, State 
and local departments of health and agriculture, and local university 
extension services to identify farm operations. Doing this on an as 
needed, case-by-case basis can be resource intensive and may, or may 
not, result in a list of operations sufficient for our needs. FDA has 
entered into a cooperative agreement with NASDA to help with the 
implementation of the produce safety regulation, and will explore 
whether and how an inventory of farms located in the United States may 
be developed and may enhance these efforts.

D. Consistency With USDA's National Organic Program (NOP)

    (Comment 14) Several comments state that the regulation may be 
interpreted to conflict with the requirements of the NOP. In this 
context, some comments specifically cited NOP's regulations in 7 CFR 
205.200, 205.205, and 205.2. Another comment expresses concern that the 
regulation would discourage farms from becoming organic certified.
    (Response) We disagree that the final produce safety regulation (or 
specifically any provisions in subparts E, F, or I) conflicts with, or 
discourages farms from following NOP standards, including the 
provisions in NOP's regulations at 7 CFR 205.200, 205.205, and 205.2. 
The provisions in 7 CFR 205.200 require, in relevant part, that 
production practices implemented in accordance with the NOP must 
maintain or improve the natural resources of the operation, including 
soil and water quality. The provisions in 7 CFR 205.205 require an 
organic producer to implement a crop rotation including but not limited 
to sod, cover crops, green manure crops, and catch crops that provide 
the following functions that are applicable to the operation: (1) 
Maintain or improve soil organic matter content; (2) provide for pest 
management in annual and perennial crops; (3) manage deficient or 
excess plant nutrients; and (4) provide erosion control. The provisions 
in 7 CFR 205.2 provide definitions of various terms for purposes of the 
NOP, including ``crop rotation,'' ``natural resources of the 
operation,'' and ``organic production.''
    Part 112, including subparts E, F, and I, does not establish any 
specific requirements that conflict with, or discourage compliance 
with, these or other NOP requirements. As noted in the 2013 proposed 
rule and the supplemental notice, consistent with sections 
419(a)(1)(A), (a)(3)(E), and (a)(3)(D) of the FD&C Act, we consulted 
with the NOP, USDA's Natural Resources Conservation Service (NRCS), 
U.S. Fish and Wildlife Service (FWS), and the EPA to ensure that 
environmental and conservation standards and policies established by 
those agencies were appropriately considered in developing the 
requirements of this rule. See also sections XIII, XIV, and XV of this 
document where we discuss the requirements related to water, biological 
soil amendments of animal origin, and animals, respectively.

E. Consideration of Environmental Standards

    (Comment 15) Several comments ask that FDA do more to support on-
farm conservation efforts and ensure that farmers can continue to use 
sustainable practices that enhance conservation and food safety. Some 
comments request that FDA codify into the regulation specific 
conservation requirements, including requirements to train farm 
personnel in conservation practices, not to destroy wild animal 
habitats, to promote natural barriers, to use sustainable conservation 
practices, and to use co-management of conservation and food safety. 
Some comments request that FDA recognize conservation practices 
intended to protect water quality; train enforcement officials on co-
management principles; and/or define the term ``co-management'' in 
relation to such requirements.
    (Response) As required by section 419 of the FD&C Act, the produce 
safety regulation establishes science-based minimum standards for the 
safe growing, harvesting, packing, and holding of produce for human 
consumption, and sets 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. As discussed in the 2013 
proposed rule and the supplemental notice, consistent with sections 
419(a)(1)(A), (a)(3)(E), and (a)(3)(D) of the FD&C Act, we consulted 
with the NOP, NRCS, FWS, and EPA to ensure that environmental and 
conservation standards and policies established by those agencies are 
appropriately considered in developing the requirements established in 
this rule.
    As discussed in the 2013 proposed rule and reiterated in the 
supplemental notice, we encourage the application of practices that can 
enhance food safety and that are also consistent with sustainable 
conservation. We believe that the provisions of part 112 are consistent 
with existing conservation and environmental practice standards and 
policies and are not in conflict with federal or State programs. In 
addition, by including Sec.  112.84, as proposed in the supplemental 
notice, we are finalizing a codified statement in the produce safety 
regulation that the requirements of part 112 do not require or permit 
the use of practices in violation of the ESA, and that the regulation 
does not require the use of practices that may adversely affect 
wildlife, such as removal of habitat or wild animals from land adjacent 
to produce fields.
    We continue to encourage the co-management of food safety, 
conservation, and environmental protection. We consider it important to 
take into account the environmental practice standards and policies of 
other relevant agencies in the context of food safety. However, the 
commenters identified no reason that it would be necessary for FDA to 
go beyond the statements we have included in Sec.  112.84 and create 
affirmative conservation-related requirements in this rule. Therefore, 
we are taking no further action in response to these comments.

F. Product Testing as a Strategy To Control Pathogens

    (Comment 16) Some comments agree with FDA's tentative conclusion 
that product testing would be impracticable as a component of this 
rule, except as proposed in subpart M under certain

[[Page 74366]]

circumstances for sprouts. One comment notes that sporadic 
contamination of produce cannot be detected reliably by product 
testing. One comment states that maintaining robust records of testing 
results will allow both farms and FDA to monitor for trends, correct 
imbalances or inaccuracies, and make adjustments to the system to best 
protect public health.
    (Response) As discussed in section IV.I of the 2013 proposed rule, 
microbiological product testing for process control purposes presents 
several challenges that make it impracticable to be included within the 
framework of mandatory, science-based minimum standards established in 
part 112, with the exception of certain testing for sprouts described 
in subpart M (see section XVIII of this document). Among other issues, 
there are challenges associated with sampling plans, indicator 
organisms, and pathogen detection such that product testing is not 
appropriate as a generally applicable strategy to control pathogens 
across all produce commodities. The final human preventive controls 
rule also notes that product testing and environmental monitoring are 
unlikely to be common in facilities complying with that rule that 
process, pack, or hold produce RACs. We agree that, when testing is 
conducted (either voluntarily or in compliance with this rule for 
sprouts), records are important and useful.

G. Aquaponic and Hydroponic Operations

    (Comment 17) Several comments request that FDA exempt aquaponic 
farming (raising produce and fish together in an integrated system) 
from the produce safety regulation, including specifically from the 
standards directed to agricultural water in subpart E, the standards 
directed to biological soil amendments of animal origin and human waste 
in subpart F, and the standards directed to domesticated and wild 
animals in subpart I. These comments argue the proposed produce safety 
rule does not address the nature of aquaponic farming. Some other 
comments suggest making it clear that the produce safety regulation is 
not intended to prohibit aquaponic practices.
    Some comments requested that the standards related to agricultural 
water not be applied to aquaponic water containing fish waste 
fertilizer that is not intended or likely to come into contact with the 
harvestable portion of the plants; aquaponic water that is drawn from 
potable sources; or to hydroponics using effluent from domestic fish or 
crustaceans that is kept under what commenters describe as closed, 
hygienic conditions (in accordance with the Aquaponic Association's 
GAPs). Other comments state that fish waste does not contain E. coli 
and, therefore, the water microbial quality and testing requirements in 
proposed Sec. Sec.  112.44 and 112.45 should not apply to water used in 
aquaponic systems. With respect to subpart F, some comments suggest the 
water and fish waste used in aquaponic and hydroponic systems should 
not be considered a biological soil amendment of animal origin. With 
respect to subpart I, some comments contend fish (including shellfish) 
are an inherently different reservoir for microorganisms than mammalian 
or avian species and, while fish may become temporary carriers of human 
pathogens, they do not act as hosts, and it is unlikely that they will 
come into contact with the harvestable portions of produce.
    (Response) We acknowledge that aquaponic farming systems present a 
particular set of circumstances that differ in important ways from non-
aquaponic farming. However, we do not agree that aquaponic farms should 
be excluded from the rule. We do not intend to prohibit using aquaponic 
farming systems to grow covered produce. The routes of contamination we 
considered for covered produce under this rule are applicable to 
aquaponic farming and covered produce grown in aquaponic systems is 
subject to the same potential for contamination from agricultural 
water, biological soil amendments of animal origin, and animals as 
covered produce grown using non-aquaponic systems.
    With regard to subpart E of this rule, when covered produce is 
grown in an aquaponic system in which the water is not intended or 
likely to contact the harvestable portion of the produce, that water is 
not agricultural water for purposes of this rule. On the other hand, 
when covered produce is grown in an aquaponic system in which water is 
intended or likely to contact the harvestable portion of the produce, 
that water is agricultural water for purposes of this rule and must 
meet the applicable standards of subpart E, including the relevant 
microbial quality requirements in Sec.  112.44 and the relevant water 
testing requirements in Sec.  112.46. Also, as discussed further in 
Comment 222, the Sec.  112.46(a) exception from water testing 
requirements applies only when water received from a public water 
system (as in Sec.  112.46(a)(1)) or a public water supply (as in Sec.  
112.46(a)(2)) is not held under your control in a way that meets the 
definitions of ``ground water'' or ``surface water'' before you use it 
as agricultural water. For example, where under the circumstances the 
water used in the aquaponic system is ``agricultural water'' (because 
it is intended to, or likely to, contact covered produce), if that 
water is from a surface water source (or held in a surface water 
capacity), it must meet the surface water testing requirements in Sec.  
112.46. For example, the testing requirements in Sec.  112.46(b) for 
untreated surface water apply to an aquaponic system that is 
established in an outdoor stream or pond, if under the circumstances 
the water meets the definition of ``agricultural water.'' With regard 
to the comments that asserted that fish do not carry E. coli, we note 
that information submitted or otherwise available to us demonstrates 
that fish can become carriers of human pathogens, including E. coli and 
Salmonella, if they are exposed to contaminated feed (Ref. 15), waters 
or sediment (Ref. 16) (Ref. 17). Studies show that fish have natural 
defenses against bacterial colonization of human pathogens, but as the 
population of the pathogen is elevated the fish become stressed and are 
no longer able to mitigate harboring the pathogens, becoming more 
susceptible to carrying human pathogens and becoming infected with 
other fish pathogens (Ref. 18). Fish are also natural carriers of 
Vibrio spp. (Ref. 19), a zoonotic pathogen.
    With regard to subpart F of this rule, we consider growth media to 
include solid or semi-solid matrices in which plants are grown; we do 
not consider liquid-only matrices to be growth media. If a liquid 
matrix in which covered produce is grown is intended to or is likely to 
contact the harvestable portion of the crop, the water is agricultural 
water subject to all applicable requirements in subpart E.
    Subpart I of this rule applies only in outdoor areas and partially-
enclosed buildings. As revised in this final rule, subpart I is not 
intended to address potential contamination from fish used as part of 
an aquaculturing system. We conclude that the risks presented by fish 
used in aquaculture are better suited to regulation via the 
requirements for agricultural water in subpart E (when the water meets 
the definition of agricultural water) and the requirements related to 
harvesting in Sec.  112.112 (for example, if covered produce is 
reasonably likely to have become contaminated by water containing fish 
waste that is not managed in compliance with subpart E's requirements 
for agricultural water). Thus, we are revising Sec.  112.81 to specify

[[Page 74367]]

that subpart I does not apply to fish used in aquaculture operations. 
We note that subpart I does apply to aquaculture operations conducted 
in outdoor areas or partially-enclosed buildings when, under the 
circumstances, there is a reasonable probability that animals other 
than the fish used in the aquaculture operation will contaminate 
covered produce. We will consider issuing additional guidance related 
to the application of this rule to aquaculture operations, as 
appropriate.
    (Comment 18) One comment presents various arguments in support of a 
position that aquaponic or hydroponic farming of produce other than 
sprouts should not be subject to the proposed requirements in subpart 
M, including asserting that there are no documented instances of 
Salmonella or E. coli transmission via aquaponic or hydroponic produce 
(other than sprouts), and that the growth conditions in aquaponic or 
hydroponic systems for produce (other than sprouts) are different and 
safer than those used to germinate sprouts. This comment also requests 
that FDA clarify that ``water used for growing sprouts'' does not cover 
water used in aquaponic or hydroponic systems for produce (other than 
sprouts) and, likewise, that the definition of ``spent sprout 
irrigation water,'' does not include water used for irrigation in 
aquaponic or hydroponic systems for produce (other than sprouts).
    (Response) We have added new Sec.  112.141 to clarify the scope of 
subpart M. Therefore, an aquaponic or hydroponic system used to grow 
covered produce other than sprouts is not subject to the requirements 
in subpart M. Likewise, ``spent sprout irrigation water'' is defined as 
``water that has been used in the growing of sprouts''; thus, the term 
spent sprout irrigation water, and the requirements for testing spent 
sprout irrigation water in subpart M, only apply to the water used for 
growing sprouts, and not to water used in an aquaponic or hydroponic 
operation growing produce other than sprouts. However, to the extent 
the specific aquaponic or hydroponic production systems used to grow 
produce other than sprouts may present risks similar to those 
associated with sprouts, we encourage aquaponic and hydroponic 
operations to consider voluntarily implementing the standards in 
subpart M.
    (Comment 19) Some comments ask FDA to consider establishing 
additional regulations specifically applicable to aquaponics 
operations, as well as to hydroponic production of crops other than 
sprouts. According to one comment, this is especially important for 
high-risk crops such as leafy greens because the use of growth media in 
hydroponic production can increase the growth of pathogens.
    (Response) At this time, we are not establishing additional 
standards specifically applicable to aquaponic or hydroponic production 
of crops other than sprouts. As noted in section V.M of the 2013 
proposed rule, sprouts present a special concern with respect to human 
pathogens compared to 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. 20) (Ref. 21). Sprouts also have been frequently 
associated with foodborne illness outbreaks and, as a result, we issued 
our first commodity-specific guidance for sprouts. Likewise, the Codex 
Alimentarius Commission (or ``the Codex'') supplemented the Codex Code 
of Practice for Fresh Fruits and Vegetables (the Codex Guide) (Ref. 22) 
with a Sprout Annex (Ref. 23). Therefore, we believe it is necessary to 
incorporate additional subpart M establishing standards specific to 
sprouts (including soil- or substrate-grown sprouts harvested with 
roots). Unlike sprouts, we believe that the production methods and 
safety considerations associated with aquaponics, generally, as well as 
with hydroponic production of crops other than sprouts, are 
sufficiently addressed through the provisions of the rule that are 
generally applicable to covered produce, including the provisions for 
water in subpart E, for soil amendments of animal origin in subpart F 
(which include growth media that serve as the entire substrate during 
the growth of covered produce), and for harvesting in Sec.  112.112. We 
will consider issuing guidance on these topics in the future, as 
appropriate. Aquaponic and/or hydroponic operations growing produce 
other than sprouts may also voluntarily choose to follow the standards 
in subpart M.

IV. Comments on the Regulatory Approach

    In the 2013 proposed rule, in section IV of that document, we 
explained in detail our tentative conclusion that we should establish a 
regulatory framework based on practices, procedures, and processes 
associated with growing, harvesting, packing, and holding of all 
covered produce. We considered and rejected 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. As discussed in the 2013 proposed rule, foodborne illness 
outbreaks have regularly been associated with commodities that have 
previously not been linked to outbreaks. Moreover, as discussed in the 
QAR, some commodities (e.g., leafy greens) have been consistently 
associated with outbreaks while others (e.g., grapes, jalapeno peppers) 
have only rarely been associated with outbreaks. In addition, 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. See also discussion at 78 FR 3504 at 3524-3528. We 
proposed an integrated approach to prescribe standards for on-farm 
routes of contamination that we 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. 
Importantly, this integrated approach does take into account 
differences in commodities in that it takes into account differences in 
practices associated with the growing, harvesting, packing, and holding 
of produce commodities. We believe this 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, provides the most appropriate balance between public 
health protection, flexibility, and appropriate management of different 
levels of risk. The requirements of this regulation are 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 require more 
stringent measures to ensure that the likelihood of contamination is 
sufficiently minimized. For example, as discussed in section XIII of 
this document, we are establishing the most stringent microbial quality 
standard 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 criteria 
for water that directly contacts the harvestable portion of covered 
produce (other than sprouts) during growing activities (when

[[Page 74368]]

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). In addition, we 
recognized the need for, and proposed, additional standards 
specifically tailored to the growing, harvesting, packing, and holding 
of sprouts.
    We requested comment on our tentative conclusions related to our 
proposed regulatory approach. We asked for comment on various issues, 
as discussed in section IV.C of the 2013 proposed rule.

A. Commodity-Specific Versus Integrated Approach

    (Comment 20) Several comments generally support our proposed 
integrated approach for various reasons, including that: (1) An 
integrated approach focuses on practices of highest risk and provides a 
whole farm approach rather than commodity-specific measures, which 
would be challenging for farms that grow multiple crops; (2) an 
approach that relies on outbreak data to make determinations about 
which produce should be covered would be inconsistent with the 
prevention-based approach mandated by FSMA; (3) relying on outbreak 
data would be insufficient to protect the public because many foodborne 
illnesses are not linked to an outbreak and the patterns of outbreaks 
associated with produce commodities change over time; (4) relying on 
pathogen surveillance data would not provide sufficient information to 
make risk determinations because FDA collects few data on produce and 
data collected are typically targeted to produce that is already known 
to be risky, which is not a preventive approach.
    In contrast, several other comments request that we develop a 
commodity-specific approach, arguing that the proposed integrated 
approach is not sufficiently based on risk or science and does not 
sufficiently align with the intent of Congress that FDA establish a 
rule that considers differences in risk among various commodities. 
Several comments contend that, with the exception of exemptions for 
produce rarely consumed raw and produce that receives commercial 
processing, FDA has proposed a generic, one-size-fits-all approach. 
Some comments maintain that, by focusing on agricultural practices, FDA 
has ignored relevant commodity-specific factors, such as adhesion and 
infiltration. Some comments also express concern that FDA did not 
consider past association with outbreaks a major determinant for 
coverage of produce commodities, contending that doing so would result 
in more cost-effective and targeted risk reduction. Still other 
comments state that there is a known and significant variation in risk 
profiles, practices, and regional differences across produce 
commodities, and ask FDA and USDA to fund research to determine the 
relative risk of microbial contamination.
    Some comments suggest FDA should analyze each commodity separately 
and develop commodity-specific requirements, and establish a level of 
regulation commensurate to the level of risk of causing foodborne 
illness presented by a specific commodity, focusing on commodities 
presenting the highest risk. Some comments point to commodities such as 
tree fruits, produce with an inedible peel, and nuts as ``low risk,'' 
and argue that such commodities should not be regulated the same way as 
other commodities that present a greater risk profile. Some comments 
state that citrus fruit is grown off the ground, the peel is generally 
not consumed, the fruit is acidic, and irrigation water generally does 
not touch the fruit and, therefore, citrus fruits should be considered 
low risk. Other comments suggest FDA should start by regulating only 
commodities that have been associated with an outbreak and consider 
expanding to include other commodities only after evaluating the public 
health benefits of the initial rulemaking. Some comments also ask FDA 
to consider the crop grouping strategies employed by other 
organizations, such as the grouping used by Codex Alimentarius (in 
Codex classification of foods); the USDA (in IR-4 project); and the EPA 
(in EPA's Crop Group listings).
    (Response) We agree with comments that indicated the integrated 
approach proposed by FDA is appropriate for a variety of reasons. We 
recognize the diversity of produce operations and agree with comments 
that pointed out that multiple, crop-specific standards could be 
confusing and burdensome both in their implementation and in assessing 
compliance, especially for diversified operations. As discussed in the 
2013 proposed rule and the QAR, we agree that an approach that relies 
on outbreak data, or certain commodity characteristics, to make 
determinations about which produce should be covered would be 
inconsistent with the prevention-based approach mandated by FSMA and 
that relying on outbreak data would be insufficient to protect the 
public because many foodborne illnesses are not linked to an outbreak 
and the patterns of outbreaks associated with produce commodities 
change over time. For example, cucumbers are frequently (although not 
always) peeled prior to consumption and, until recently, did not have a 
history of association with outbreaks. In 2009, based on literature 
indicating the potential for cucumbers to be contaminated with 
Salmonella (Ref. 24) (Ref. 25), we added cucumbers to our routine 
surveillance sampling assignments and, in fact, detected an outbreak 
linked to cucumbers that year (Ref. 26) (Ref. 27). Between 2011 and 
2014, we have identified cucumbers as the food vehicle in three 
additional outbreaks (Ref. 28).
    FDA based its proposal of a practices-based approach in part on the 
results of our draft QAR. We received public comment on the QAR and 
also had it peer reviewed and have now issued a final QAR (or the QAR), 
which incorporates revisions based on public comments and the peer 
review (Ref. 29). While we have made some revisions, the conclusions of 
the QAR are unchanged. We conclude that, while different commodities 
may have different risk profiles at different stages of production, all 
commodities have the potential to become contaminated through one or 
more of the routes identified, especially if practices are poor and/or 
conditions are insanitary. Commenters did not provide information 
affecting this conclusion. We also conclude that commodity 
characteristics, such as an inedible peel or the fact that it is grown 
off the ground, may be relevant to relative likelihood of contamination 
during growing, but are not good indicators of an association, or lack 
thereof, with outbreaks. Commenters also did not provide information 
affecting this conclusion. The QAR looked at likelihood of 
contamination during growing, harvest, and postharvest activities for 
47 commodities and found that commodity characteristics, including 
microbial adhesion and infiltration considerations, were not reliably 
protective against contamination, as evidenced by past association with 
an outbreak for a range of commodities with variable characteristics. 
For example, if a pathogen is present on the surface of the peel or 
rind of a piece of fruit, cutting the fruit with a knife can carry the 
pathogen into the edible portion of the fruit (Ref. 30). Indeed, 
produce commodities with a peel or removable outer layer, such as 
honeydew, cantaloupe, papaya, and mango, have previously been 
associated with outbreaks of foodborne illness. From 1997 to 2014, 
there have been a total of 20 outbreaks in the United States

[[Page 74369]]

associated with produce commodities sold whole (not fresh-cut) where 
the commodity has an outer peel that is removed prior to consumption, 
with a range of pathogens (Salmonella, Shigella, and Listeria) 
implicated in the outbreak (Ref. 28) (Ref. 29). The public health 
consequences of these outbreaks have been significant. For example, the 
2011 L. monocytogenes outbreak in the United States associated with 
cantaloupe resulted in 147 reported cases of illness, 143 reported 
hospitalizations, and 33 reported deaths (Ref. 28).
    With regard to comments asking that we start by regulating only 
commodities that have been associated with an outbreak, we note in the 
QAR that ``new'' commodities are associated with outbreaks on a regular 
basis, which means that a history of outbreaks is not appropriate as a 
basis for determining the regulatory status of various commodities. 
Many comments asked that we consider factors such as commodity 
characteristics or past association with an outbreak to define a subset 
of low risk commodities that would be exempt from the requirements of 
part 112. However, these comments did not provide data that affected 
the findings of the QAR, and in finalizing this rulemaking we continue 
to conclude that the integrated approach is the appropriate regulatory 
framework to ensure the safety of produce.
    In considering options for the regulatory framework for the produce 
rule, we considered the crop groupings used by Codex Alimentarius, the 
IR-4 project, and EPA's crop grouping designations (Ref. 31) (Ref. 32) 
(Ref. 33), which were suggested by comments. These programs categorize 
commodities based on commodity characteristics, production practices, 
or pest pressures. They were not created for the purposes of 
characterizing relative risk of causing serious adverse health 
consequences or death, or to determine what procedures, processes, and 
practices should apply to such commodities to minimize the risk of 
serious adverse health consequences or death. Thus, we did not find 
these groupings appropriate for purposes of this regulation. As 
demonstrated by the QAR, 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 the 2013 proposed rule, we specifically sought comment on 
various possible strategies for developing a commodity-specific 
approach, including covering only commodities/commodity groups that had 
been associated with outbreaks during a specified time period; covering 
only commodities/commodity groups that had ever been associated with an 
outbreak; and combining outbreak-based commodity classification with 
other information, such as commodity characteristics, or pathogen 
surveillance data. We noted specific problems with each of these 
approaches. In summary, commenters did not provide data or information 
suggesting that the problems we identified could be adequately 
addressed to allow development of a commodity-specific approach that 
would be sufficiently protective of public health. As a result, we are 
finalizing our conclusion that the integrated approach is the most 
appropriate, risk-based, and scientifically sound approach, and we are 
adopting such an approach.
    We also asked specific questions in the 2013 proposed rule 
regarding whether we might additionally exclude commodities beyond 
those we identified as the lowest risk (i.e., those that are rarely 
consumed raw and those that receive commercial processing that 
adequately reduces pathogens). We asked if produce, such as bananas and 
coconuts, that 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 be covered by the rule or 
subject to a less stringent set of requirements (78 FR 3504 at 3528). 
We received several comments indicating that bananas should not be 
covered because they have an inedible peel, which according to 
commenters means that it is unlikely that contamination will contact 
the edible portion. In response to our questions in the preamble, no 
comments identified any unique characteristics, in addition to the ones 
we identified, of bananas and coconuts that would justify their 
exemption. We indicated with our question a characteristic of bananas 
and coconuts that might put them in a lower risk category than other 
commodities. However, there is no evidence that bananas and coconuts 
are lower risk than other low-risk commodities or that the method of 
peeling or opening these commodities generally precludes transfer of 
contamination on the exterior to the edible portion. As noted in the 
QAR, there are limited data on the effect of cutting and peeling on the 
levels of pathogens across the range of produce commodities (Ref. 29). 
In addition, in the final QAR, while both bananas and coconuts have low 
`route scores' in the assessment of potential routes of contamination 
and likelihood of contamination on-farm, other commodities have lower 
scores. As noted previously, we continue to conclude that commodity 
characteristics, such as an inedible peel or the fact that produce is 
grown off the ground, may be relevant to relative likelihood of 
contamination during growing, but are not good indicators of an 
association, or lack thereof, with outbreaks. Therefore, we conclude 
that they should be subject to part 112.
    We also asked about certain commodities that are ranked in the QAR 
as presenting a relatively lower likelihood of exposure, in part 
because they have fewer potential routes of contamination and/or lower 
potential for contamination and have not previously been associated 
with an outbreak. We asked if commodities that meet both these criteria 
should be subject to the rule or subject to a less stringent set of 
requirements (78 FR 3504 at 3528). We specifically mentioned pears, 
grapefruit, oranges and lemons as examples. As noted earlier, we 
received a comment arguing that citrus fruits should be considered low 
risk commodities due to the fact that they are acidic, have a rarely 
consumed peel, are grown in trees, irrigation water generally does not 
touch the fruit, and citrus fruits have not been associated with 
outbreaks. However, the comment did not ask for citrus to be exempt, 
but to be deemed in compliance with the rule if farms are in compliance 
with the Citrus industry's good agricultural practices (the Citrus 
GAPs) (Ref. 34). However, while different commodities may have 
different risk profiles at different stages of production, all 
commodities have the potential to become contaminated through one or 
more of the routes identified, especially if practices are poor and/or 
conditions are insanitary. In addition, commodity characteristics, such 
as an inedible peel or the fact that it is grown off the ground, may be 
relevant to relative likelihood of contamination during growing, but 
are not good indicators of an association, or lack thereof, with 
outbreaks. For these reasons, and because comments provided no other 
information to suggest that citrus fruits or pears should not be 
covered by the rule, we conclude that they should be subject to part 
112. With regard to compliance with the Citrus GAPs, see Comment 143.
    (Comment 21) One comment suggests that, as an alternative to 
developing a commodity-specific regulatory approach, FDA should provide 
for a notification process by which industry can voluntarily notify FDA 
about a particular commodity that should be

[[Page 74370]]

characterized as low risk and, therefore, exempt from the produce 
safety regulation.
    (Response) We believe the alternative and variance provisions, in 
subparts B and P, respectively, provide adequate flexibility to address 
particular situations, and the rule otherwise provides exemptions for 
certain types of low-risk produce (Sec. Sec.  112.2(a)(1) and (b)). We 
are not establishing an additional process or exemptions.
    (Comment 22) We received numerous comments stating that we have 
adopted a ``one-size-fits-all,'' rigid and prescriptive approach. These 
comments argue that our proposed approach is not flexible or scale 
appropriate.
    (Response) Under our regulatory approach, the scope and stringency 
of the requirements are based on risk, and depend in several cases on 
the types of practices employed within operations, such that producers 
of different commodities who use different practices will not 
necessarily be subject to all of the same requirements. We note that 
Sec.  112.4(a) requires that ``[i]f 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'' (emphasis 
added). As discussed in the 2013 proposed rule, given various 
considerations, we proposed an integrated approach that draws on our 
past experiences and appropriately reflects the need to tailor 
requirements to specific on-farm routes of contamination. In some 
cases, our standards are similar to current good manufacturing 
practices-type provisions, 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). In other cases, our standards require 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 visual assessment for working or grazing animals or animal 
intrusion in Sec.  112.83 and inspection of agricultural water system 
in Sec.  112.42). In still other cases (e.g., sprouts), our standards 
require the farm to develop a written plan, committing itself to 
specific measures (e.g., sprout environmental testing and spent sprout 
irrigation water testing). Finally, on a limited basis, we are 
establishing specific numerical standards against which the 
effectiveness of a farm's measures would be compared and actions that 
would be taken to bring the operation into conformance, as necessary 
(e.g., microbial quality criteria for agricultural water in subpart E). 
We rely on the numerical standards approach where our evaluation of 
current scientific information to determine reasonable measures allows 
us to establish numerical criteria that are broadly applicable across a 
wide range of conditions, while acknowledging that such criteria may be 
tailored, as appropriate, when applied specifically to a commodity (or 
group of commodities) or under a set of farm practices.
    We incorporated flexibility into the standards, where appropriate, 
so covered farms are able comply with the requirements while taking 
into account their specific commodities and conditions in their 
operations, and risk profile associated with them. For example, we 
define ``agricultural water,'' in relevant part, to mean water that is 
intended to, or likely to, contact the harvestable portion of the crop 
or food-contact surfaces, thus allowing consideration of commodity-
specific characteristics and/or practices. For example, if irrigation 
water does not contact the produce (e.g., drip or furrow irrigation of 
tree fruit), the microbial quality criteria for agricultural water 
applied during growing using a direct water application method (for 
produce other than sprouts) do not apply because the water is not 
``agricultural water'' as we have defined that term. We also 
incorporated additional flexibility to accommodate future changes in 
science and technology and the particularities of local growing 
conditions and commodities. Under Sec.  112.12, we list the specific 
numerical standards established in this rule for which we allow 
alternatives to be established and used in appropriate circumstances. 
This provision provides significant flexibility by allowing individual 
farms to develop alternative standards suitable to their operations 
with appropriate scientific support (for example, under Sec. Sec.  
112.12(a) and 112.49(a), alternatives are permitted to the microbial 
quality criteria in Sec.  112.44(b) related to agricultural water used 
in a direct application method during growing of produce (other than 
sprouts)). In addition, in subpart P, we provide for a mechanism by 
which a State, tribe, or a foreign country from which food is imported 
into the United States may request a variance from one or more 
requirements of part 112, where such variance, among other conditions, 
is demonstrated to provide the same level of public health protection 
as the relevant requirement(s) of part 112.
    Taking into account comments in response to the 2013 proposed rule 
and as proposed in the supplemental notice, we incorporated further 
flexibility in certain key areas such as the standards for agricultural 
water. For example, Sec.  112.45(b)(1) provides additional means by 
which to satisfy the microbial quality criteria for agricultural water 
that is used in a direct application method during the growing of 
produce (other than sprouts). Allowing for microbial die-off between 
last irrigation and harvest and/or microbial reduction or removal 
resulting from postharvest practices provides covered farms viable 
options to meet the microbial quality criteria without needing to, for 
example, treat water or switch to a ground water source. This 
additional flexibility recognizes the diversity of commodities and 
production practices. It may also be useful for other postharvest 
activities, for example, commercial washing and controlled atmosphere 
storage of apples, with adequate supporting data and documentation.
    We believe the coverage threshold, qualified exemption, and 
extended compliance periods adequately address concerns related to 
scale-appropriate regulation of farms. We have provided as much 
flexibility as is appropriate while maintaining the overall public 
health goal of this produce safety regulation. This regulation does not 
apply to those businesses with $25,000 or less in sales of produce, as 
described in Sec.  112.4(a), because such farms do not contribute 
significantly to the produce market and, therefore, to the volume of 
production that could become contaminated. In addition, for farms that 
fit our criteria for very small business or small business, we are 
providing extended compliance periods ranging from two to three years 
for covered activities involving sprouts; and ranging from three to 
four years for most provisions coupled with more time for certain 
water-related requirements for covered activities involving all other 
covered produce (see section XXIV of this document), so they are given 
sufficient time to make any necessary adjustments to their current 
practices. There are also provisions for qualified exemption for 
certain farms based on monetary value and direct-to-consumer sales, and 
associated modified

[[Page 74371]]

requirements, as described in Sec. Sec.  112.5, 112.6, and 112.7.
    In addition, the provisions in subpart A provide risk-based 
exemptions for certain types of produce based on our determination that 
the manner in which the produce is consumed does not require that 
produce to be subject to the requirements in part 112. We are exempting 
produce commodities that are rarely consumed raw (Sec.  112.2(a)(1)). 
Produce that receives commercial processing that adequately reduces the 
presence of pathogens is also eligible for exemption under certain 
conditions (Sec.  112.2(b)).
    (Comment 23) One comment asks whether covering all commodities in 
the rule is compliant with the provisions of the WTO-SPS agreement 
about the appropriate level of protection. This commenter expresses 
concern specifically with respect to covering under this rule those 
fruits and vegetables that have an inedible peel and that are peeled 
before consumption.
    (Response) We believe that the regulatory framework underlying the 
science-based minimum standards established in part 112 is supported by 
currently available scientific information, as explained throughout the 
2013 proposed rule and in this rule and, as such, satisfies our 
obligations under the WTO-SPS agreement. We also note that not all 
produce commodities are subject to the rule. Section 112.2(a)(1) 
specifies certain commodities that are not covered based on our 
conclusion that they are rarely consumed raw. See Comment 20 for our 
consideration of produce with inedible peel.

B. Use of Quantitative Metrics

    (Comment 24) Several comments express concern with the use of 
quantitative metrics in the rule. For example, one comment indicates 
the proposed requirements in subpart I to ``monitor . . . for evidence 
of animal intrusion'' and ``evaluate whether the covered produce can be 
harvested'', allows for regional and commodity diversity and provides 
sufficient flexibility to be applicable to any operation, whereas the 
quantitative metrics, such as in proposed Sec. Sec.  112.44, 112.45, 
112.55 and 112.56, are too prescriptive and inflexible to be codified 
in the regulation. Several comments argue the current status of produce 
safety research is inadequate to establish the quantitative metrics as 
applicable to all commodities and regions and all situations. Another 
comment asks us to limit the metrics to those for which sufficient 
scientific evidence exists that such standards will protect public 
health and reduce risk. Some comments argue that guidance would be a 
more appropriate vehicle to convey quantitative metrics, as 
recommendations rather than requirements, because there is such 
variation in region, operations, and commodities, and because guidance 
is easier to amend than a regulation.
    (Response) The standards that FDA is issuing in part 112 are based 
in science. Taking into account comments received in response to the 
2013 proposed rule we proposed revisions to some provisions in the 
supplemental notice and explained our rationale, including scientific 
support for those new and amended proposed provisions. Among proposed 
Sec. Sec.  112.44, 112.45, 112.55, and 112.56, which included 
quantitative criteria, there was one, the minimum application interval 
for an untreated biological soil amendment of animal origin in proposed 
Sec.  112.56, for which we indicated that we would conduct further 
research and a risk assessment. FDA has committed to pursuing this work 
before revisiting the interval. We conclude we have an adequate basis 
on which to finalize the metrics in this rule, including in final 
Sec. Sec.  112.44, 112.45, 112.46, and 112.55. For a discussion of the 
final provisions, and comments received in response to the supplemental 
notice, we refer you to sections XIII and XIV of this document. We 
disagree with comments that suggest eliminating all quantitative 
metrics from this rule in favor of recommending such numerical criteria 
in guidance. We believe it is clearer to regulated industry to 
establish these metrics in the rule, and important for public health 
that these metrics be binding requirements rather than recommendations.

C. Scientific Support for the Rule

    (Comment 25) Some comments state the record of proven on-farm 
causation of outbreaks is thin. One comment acknowledges our estimates 
of produce-related reported outbreaks, outbreak-related illnesses, 
hospitalizations, and deaths, and argues that, although these adverse 
impacts are regrettable, the number of deaths pale in comparison to the 
2.5 million total deaths in the country, including about 35,000 caused 
by motor vehicle accidents.
    (Response) In the 2013 proposed rule, FDA outlined the history of 
contamination associated with produce, predominantly during growing, 
harvesting, packing, and holding (78 FR 3504 at 3507), from 1996 to 
2010. On-farm contamination of produce is well documented. We also 
developed and finalized the QAR which evaluates likely routes of 
contamination for 47 produce commodities, including pre-harvest and 
postharvest activities on farms. We have updated our outbreak data 
since the 2013 proposed rule issued, and between January 2011 and 2014, 
there were 44 outbreaks, 3120 illnesses, 735 hospitalizations, and 42 
deaths associated with produce (including sprouts) (Ref. 28). We 
continue to conclude that there is an ample history of microbiological 
contamination of produce on farms to justify establishing the 
provisions of part 112 to help prevent contamination and illness. This 
rule is also consistent with our statutory mandate to develop standards 
for the safe production and harvesting of produce to minimize the risk 
of serious adverse health consequences or death.
    (Comment 26) One comment questions FDA's interpretation of the term 
``scientifically valid,'' which, according to the commenter, relies too 
much on peer review for validation.
    (Response) We use the term ``scientifically valid'' to mean an 
approach that is based on scientific information, data, or results 
published in, for example, scientific journals, references, text books, 
or proprietary research. Use of peer-reviewed literature is just one 
component of what we mean by the term ``scientifically valid;'' 
however, we continue to believe that peer-reviewed literature may be an 
important source of validation of, for example, a procedure, process, 
or practice allowed as an alternative to a specific requirement of this 
rule under Sec.  112.12.
    (Comment 27) Some comments suggest we should revise the regulation 
to align with what the commenters identify as the modern microbial 
ecology paradigm, stating that achieving public health goals is more 
complex than eliminating pathogens and that exposure to diverse 
microbes may be necessary for health.
    (Response) We do not expect or intend for this rule to bring about 
a ``microbe-free'' food production system. We acknowledge that 
eliminating all pathogens would not be a realistic expectation, 
especially in an open field environment. However, foodborne illness 
associated with consumption of contaminated produce can carry high 
public health and financial costs. Many produce contamination events 
are preventable, and we will work with industry and other stakeholders 
to achieve successful implementation of this rule and, ultimately, 
protect public health. This rule is also consistent with our statutory 
mandate to develop standards for the safe production and harvesting of 
produce to minimize the

[[Page 74372]]

risk of serious adverse health consequences or death.

D. Market Channels

    (Comment 28) We received several comments in response to our 
question about whether and how we could use market channels as a factor 
in the rule beyond inclusion of the qualified exemption that already 
takes market channels into account. One commenter states that local 
food is less risky because there is less time between harvest and 
consumption (and, therefore, less time for pathogen growth and 
multiplication) as well as less centralized processing with potential 
for cross contamination. This comment argues that FDA's analysis 
confuses data on hazards that occur on-farm, with hazards that occur 
off-farm, including hazards that occur later in the chain of 
production. In addition, one comment suggests that FDA should support 
research and data collection to compare the risks of different types of 
supply chains, including direct-to-consumer and multiple ``touch-
points'' supply chains. One comment recommends establishing a three-
tiered structure for the regulation of produce safety, reflecting 
current produce production and marketing systems. As recommended, the 
three tiers would be: (1) ``Farm-direct,'' which would include farm 
stands, farmers' markets, community supported agriculture (CSA) 
programs (e.g. subscription farms) and other strategies where the 
relationship between individual farmers and consumers is ``immediate 
and understood;'' (2) ``identity-preserved,'' which would include 
distribution on a regional scale where the farmer and consumer do not 
necessarily meet, but the identity of the farm is displayed or 
otherwise preserved on products all the way through the system; and (3) 
``commodity-stream,'' which would include other distribution systems 
besides ``farm-direct'' and ``identity-preserved.''
    (Response) FDA disagrees with the commenter who argues that we are 
using off-farm food safety data to justify control of farming 
practices. We recognize that contamination can happen at any point in 
the supply chain. In a review of outbreaks in the United States 
attributed to fresh leafy vegetables between 1973 and 2012, Herman and 
colleagues noted that most (85 percent) fresh leafy vegetable outbreaks 
during the study period were attributed to food prepared in a 
restaurant or catering facility (Ref. 35). According to Herman et al., 
the large number of fresh leafy vegetable outbreaks in which the food 
was prepared in a restaurant and contaminated with norovirus, often by 
an ill food worker, underscores the need to enforce safe handling 
practices for food workers for these types of foods. The authors also 
noted, however, that contamination of leafy vegetables early in 
production by bacterial pathogens such as Shiga-toxin producing E. coli 
(STEC) and Salmonella caused nearly all multistate outbreaks associated 
with those commodities, including some of the largest leafy vegetable 
outbreaks: Shigella and fresh parsley in 1998, Hepatitis A and green 
onions in 2003, E. coli O157:H7 and spinach in 2006. Furthermore, leafy 
green vegetables used in ready-to-eat pre-packaged salads retain much 
of their indigenous microflora after minimal processing, including 
pathogens, if present (Ref. 36).
    The focus of the produce rule on contamination on-farm, the 
earliest point in the supply chain, is consistent with FSMA's focus on 
prevention of food safety problems. On-farm routes of contamination 
have been well documented. However, this does not mean that FDA is 
singling out farms as the only source of contamination for produce; 
other efforts are directed to potential contamination at later stages 
of manufacturing and processing. For example, the PCHF regulation 
addresses manufacturing/processing operations for food, including 
produce commodities; the FDA Model Food Code (Ref. 37) addresses 
practices at the retail level; and educational campaigns, such as 
consumer advice for safe handling of raw produce and juice (Ref. 38) 
(Ref. 39), are designed to enhance safe handling practices by 
consumers.
    We decline to establish the three-tiered system advocated for by a 
comment. The comment described potential categorizations that relate to 
traceability of produce. Tracing may be easier when only selling 
through the types of arrangements described in the commenter's ``farm-
direct'' category, or in a manner described in the commenter's 
``identity-preserved'' category; however, the goal of this regulation 
is the prevention of foodborne illness. The commenter did not provide 
data or information from which we can conclude that the ``farm-direct'' 
or ``identity-preserved'' market channels described represent lower 
risk of foodborne illness, only that such market channels may better 
facilitate traceback after illness occurs.
    As discussed in the 2013 proposed rule, we acknowledge that the 
number of opportunities for contamination during packing and holding 
may be greater for produce in market channels involving greater numbers 
of handlers and touch points. At the same time, we concluded that 
produce in both direct market channels and other commercial channels 
are subject to the same routes of contamination, and we indicated that 
we were not aware of any data that would allow us to compare the 
likelihood of contamination for produce in more or less direct market 
channels. This rule includes the statutory qualified exemption which 
addresses market channels (see section 419(f) of the FD&C Act, and 
Sec.  112.5). We identified no data that would allow us to otherwise 
use market channels as a basis of risk categorization under this rule. 
Nor did commenters provide any data or factual information that would 
allow us to do so. We believe that the commenter who advocated the 
three tiered system described previously is arguing that it is most 
important from a public health standpoint to focus our efforts on large 
farms that sell produce through attenuated supply chains. We agree that 
we should prioritize our enforcement and compliance efforts in an 
efficient way that is based on risk. See our discussion in section XXII 
of this document. We also note that the proposed revised definition of 
``retail food establishment'' (80 FR 19160; April 9, 2015) may affect 
the number of farms that are subject to the requirements of part 112.

E. Guidance in Lieu of the Produce Safety Regulation

    (Comment 29) Several comments recommend that FDA consider issuing 
guidance, or otherwise providing information and advice to farms, in 
lieu of establishing the produce safety regulation. These comments note 
there is a tremendous amount of research being done to address known 
produce safety issues and enhance produce safety, and use of guidance 
rather than a regulation would allow FDA to readily and easily 
incorporate new science and preventive controls as they become 
available. Some comments state FDA has not explained why we determined 
not to adopt a voluntary approach and request that any guidance 
documents consider industry-developed recommendations. Some commenters 
ask FDA to consider the number of other regulations with which farms 
must currently comply, suggesting that further regulation is 
unnecessary.
    (Response) Under section 419 of the FD&C Act (created by section 
105 of FSMA), Congress explicitly requires the issuance of regulations 
establishing science-based minimum standards for the safe production 
and harvesting of those types of fruits and vegetables, including 
specific mixes or categories of

[[Page 74373]]

fruits and vegetables, that are RACs for which the Secretary has 
determined that such standards minimize the risk of serious adverse 
health consequences or death. Adopting a voluntary approach, in lieu of 
regulatory requirements, does not fulfill this statutory mandate nor 
does it achieve the public health objectives intended by the produce 
safety regulation. Rather, this rule implements the statutory mandate 
described in section 419 of the FD&C Act. We also recognize that there 
are many requirements with which produce farms must comply, including 
environmental and worker safety regulations. However, such regulations 
do not minimize the risk of severe adverse health consequences or death 
from produce for consumers, which is the goal of part 112.
    FDA recognizes that there are many growing situations across the 
country and abroad, each of which is unique to a particular growing 
region and site location, and that there may be different measures a 
farmer can take to prevent and/or minimize food safety risks in 
compliance with the regulation. In this regard, we note that part 112 
gives farm operators sufficient flexibility to tailor their practices 
as appropriate to achieve compliance with the applicable produce safety 
standards. Moreover, guidance will play an important role in providing 
recommendations to assist farms in tailoring their activities to the 
conditions, practices and commodities specific to their farm. As 
discussed throughout this document, we intend to issue guidance to help 
covered farms comply with the requirements of this rule, including a 
SECG specifically intended for small and very small businesses.

F. Existing Industry Guidelines and Certification Programs

    (Comment 30) Several comments request FDA approve or recognize 
existing industry voluntary programs, and accept participation in such 
programs as a means to meet the requirements of the produce safety 
rule. Some comments believe such programs are as protective, or more 
protective, of public health than the proposed produce safety rule. 
Some comments note that many farms currently use and understand 
voluntary auditing and other food safety programs such as the USDA Good 
Agricultural Practices (GAP) and Good Handling Practices (GHP) 
programs, the Global Food Safety Initiative's (GFSI) food safety 
program, the California Leafy Greens Marketing Agreement (CA LGMA) 
(Ref. 40), the California Cantaloupe Marketing Order, the Arizona Leafy 
Greens Products Shipper Marketing Agreement (AZ LGMA) (Ref. 41), the 
Florida Tomato Good Agricultural and Best Management Practices 
programs, the Citrus GAPs, and the Massachusetts GAP and Commonwealth 
Quality programs. Some comments argue that it would not be efficient to 
create a separate inspection framework under the produce safety 
regulation without taking steps to provide integration with such 
existing programs, and integrating inspections would allow FDA to focus 
its resources on operations that are not part of an existing system. 
Some comments state that the internal and external audit components of 
these programs would serve as an additional check to ensure food safety 
practices are being implemented effectively at farms. Some comments 
suggest that FDA should grant an exemption or an alternative or 
variance for GAP-certified farms, those participating in the CA LGMA or 
AZ LGMA, or those complying with other certification programs.
    (Response) FDA appreciates the efforts of commodity groups and 
industry segments that have proactively developed food safety programs. 
We also appreciate that farms currently implementing these programs may 
have developed an understanding and comfort level with the provisions 
in these programs. Such farms will likely be well-positioned to comply 
with this rule.
    To the extent that certification schemes or food safety programs 
are consistent with the produce safety regulation, then compliance with 
those schemes or programs could be relevant to compliance with the 
requirements of part 112. We reviewed widely used food safety schemes 
and programs in developing this rule and note that there are 
consistencies with several of the provisions of this rule. We 
understand that, as of the publication of this document, many of the 
widely used food safety schemes and programs will be considering 
whether and how to revise their provisions in light of the requirements 
of FDA regulations, including this produce safety regulation and our 
other new FSMA regulations. Over time, we expect that certification 
programs and food safety programs will develop tools to demonstrate the 
alignment of their provisions with FDA requirements. FDA believes there 
is value in such efforts and will consider the possible implications 
for FDA's work if and when such information on alignment is available. 
With respect to the comment about alternatives or variances, see our 
response to Comment 143.

G. Reducing Burden on Small Farms

    (Comment 31) Some comments request a range of options designed for 
small and mid-sized agricultural operations, and express concern about 
the burden of the rule on small farms and their ability to stay in 
business. Some comments state the rule should be established in a 
manner that does not create a burden on new farm startup enterprises. 
Comments also request the rule minimize burden on smaller operations by 
streamlining and reducing unnecessary paperwork. Several comments agree 
problems with food safety need to be addressed, but request FDA's 
emphasis should be on ``industrial agriculture,'' which they contend is 
the primary source of food safety problems, rather than on small farms. 
One comment suggests costs of compliance will be more burdensome to 
small farms than to large farms because certain costs, such as those 
associated with water testing, paperwork, and documentation, remain 
relatively constant regardless of the size of the operation.
    (Response) FDA appreciates that this rule will establish, for the 
first time, regulatory requirements for on-farm growing, harvesting, 
packing, and holding of produce. We also appreciate that implementing 
the requirements of this rule will come with a cost, both in time and 
resources. As discussed in section IX of this document, we have 
incorporated a coverage threshold (Sec.  112.4(a)) and a qualified 
exemption and corresponding modified requirements (Sec. Sec.  112.5, 
112.6, and 112.7), as well as extended compliance periods (see section 
XXIV of this document) each based, in part, on the size of the farm. We 
conclude that these provisions adequately address the concerns of small 
farms and are in compliance with our statutory mandate under section 
419 of the FD&C Act. This rule also provides sufficient flexibility to 
allow individual operations to tailor their practices as appropriate. 
Our recordkeeping requirements established in subpart O of part 112 
allow farms to use existing records, and do not require duplication 
provided such records satisfy all of the applicable requirements of 
part 112. FDA agrees that education, training, and technical assistance 
to farmers is important. As mentioned throughout this document, FDA 
will be issuing guidance, including SECG, specifically aimed at 
assisting small and very small farms to comply with the requirements of 
this rule. See also Comment 3 and sections XI and XXII of this 
document.

[[Page 74374]]

    (Comment 32) Some comments assert the rule will disproportionately 
affect New England farmers, with negative impacts on New England's food 
supply because New England farms are small and production costs are 
higher compared to elsewhere in the country. Other comments assert this 
rule will force small farmers out of business, forcing the United 
States to rely on foreign suppliers who these commenters assert are 
under very little FDA oversight. These comments argue the requirements 
of this rule should be reduced in various ways as a means of supporting 
small, local farmers. Other comments express concern that this rule 
will discourage farmers from supplying the ``Farm to School'' market.
    (Response) We believe that the ``farm'' definition that we have 
established in the PCHF regulation, and which we are adopting into part 
112 through this rule, reduces the impact of the FSMA rulemakings on 
farms of all sizes, because several types of operations that were 
required to register as food facilities under the section 415 
registration regulations as established in 2003 (68 FR 58894, October 
10, 2003) will no longer be required to do so by virtue of the changes 
we are making to the definition of ``farm.'' (See the discussion of the 
changes to the ``farm'' definition in section IV of the final human 
preventive controls rule (80 FR 55908).) In addition, a farm that has 
annual sales of produce below the monetary threshold in Sec.  112.4(a) 
is not covered under this rule. Moreover, under Sec.  112.5, a farm is 
eligible for a qualified exemption (and subject to certain modified 
requirements) if it satisfies certain criteria. We are also 
establishing delayed compliance dates for small and very small 
businesses as discussed in section XXIV of this document. All of these 
factors will reduce the burden of this rule on small farms.

H. Estimated Produce Outbreaks and Associated Illnesses

    (Comment 33) Several comments question our analysis and estimates 
of produce-related outbreak illnesses. According to these comments, the 
number of outbreaks and health consequences should be reduced by 
removing known foreign-sourced outbreaks. Some comments point out 
limitations of the CDC dataset, including that the data do not 
differentiate between illnesses caused by contamination in the 
production of produce and contamination due to improper handling by the 
consumer, and that the data do not include illnesses caused by 
``unspecified agents''. Finally, some comments contend that FDA should 
limit its consideration of past outbreak data on which it relies in the 
proposed regulation; for example, if previous outbreaks are related to 
activities that would be covered by the proposed Preventive Controls 
for Human Food rule, then these comments argue that FDA should not 
consider those outbreaks when determining the risk of activities 
covered by the produce safety regulation.
    (Response) FDA acknowledges that there are a number of limitations 
associated with available outbreak data. For example, the data do not 
include illnesses that were not reported, sporadic cases of illness, or 
illnesses transmitted person-to-person (secondary transmission). The 
data also do not include a large number of reported illnesses/outbreaks 
where the contaminated food vehicle cannot be determined. The data do 
not include illnesses/outbreaks where the point of contamination is 
determined to be the home, retail, or institutional setting. We thus 
conclude that, if anything, our dataset likely undercounts the number 
of outbreaks associated with the production of produce. We disagree 
with comments that suggest illnesses and outbreaks attributed to 
foreign sources should be excluded from data considered in support of 
this rule. Our goal is to minimize illnesses and deaths associated with 
the consumption of contaminated produce. Imported produce, like 
domestically-grown produce, contributes to the risk of foodborne 
illness from contaminated produce and is therefore relevant to this 
rulemaking.
    Finally, while we are not counting these illnesses for purposes of 
the Regulatory Impact Analysis (RIA) for this rule, we are otherwise 
considering them in our assessment in the QAR and in establishing this 
rule. We have determined that it is most appropriate to attribute the 
benefits of avoiding fresh-cut produce related illnesses to the PCHF 
regulation for purpose of economic analysis to avoid double counting 
such benefits; however, we note that it appears that in several cases, 
the most likely point of original contamination for the fresh-cut-
related outbreaks occurred on the farm rather than at the fresh-cut 
facility. Both farms and fresh-cut manufacturing/processing operations 
provide routes of contamination that may contribute to adulteration of 
fresh-cut produce, and the integrated system of preventive controls we 
are establishing under FSMA is intended to address these risks at 
multiple stages in the farm-to-table continuum. Thus, illnesses 
attributable to fresh-cut produce are relevant to both this rule and 
the PCHF regulation even though the economic benefits of avoiding 
illnesses attributable to such products are being estimated only in the 
RIA for the PCHF regulation.

I. Impact on Traditional Farming Methods

    (Comment 34) Several comments express concern that the proposed 
produce safety rule would impose undue restrictions on traditional 
farming methods. Comments indicate concern with our proposed approach 
as applied to diversified livestock-crop farms, the use of working 
animals, and the use of biological soil amendments of animal origin. 
These comments urge FDA to remove restrictions applicable to these 
methods of farming, absent data showing an actual, verified increased 
rate of foodborne illness associated with use of such. In addition, 
these comments argue that FDA is inappropriately placing the burden on 
farmers to prove that their methods are safe.
    (Response) We disagree the produce safety regulation would impose 
undue restrictions on traditional farming methods, such as diversified 
livestock-crop farms, the use of working animals, or the use of 
biological soil amendments. These issues are further discussed in 
sections XIV (standards directed to biological soil amendments) and XV 
(standards directed to animals) of this document. We have made changes 
in those subparts that we expect will address at least some of these 
commenters' concerns. See also section III.E of this document. Farms 
have a responsibility to produce food that complies with the FD&C Act, 
and FDA disagrees that we are inappropriately placing burden on farmers 
to prove that their methods are safe. We are establishing requirements 
in this rule that will minimize the risk of serious adverse health 
consequences or death from produce. We are also establishing a rule 
with significant flexibility for farms to tailor their practices to 
their operations while remaining in compliance with the rule. We intend 
to commit significant resources to education, training, and technical 
assistance to help farms comply with the rule--see section XXII of this 
document. Also, as discussed in section X of this document, although we 
expect farms that establish and use an alternative approach (where 
permitted) to have the necessary scientific data or other information 
in support of that alternative, such data or information may be 
developed by you, available in

[[Page 74375]]

the scientific literature, or available to you through a third party. 
We anticipate that the necessary scientific support for an alternative 
could be developed with broad efforts across the produce community, 
involving academia, extension services, industry associations, and 
federal, State, tribal, and local government agencies. FDA is 
collaborating with partners on research that may provide scientific 
support for specific alternatives, and we intend to disseminate useful 
scientific information, when available, and issue commodity- and 
region-specific guidance as appropriate, such that farmers would be 
able to consider our recommendations and apply the new scientific 
information to their operations, as appropriate.

J. Other Comments

    (Comment 35) Comments strongly encourage FDA to interact with the 
retail community to promote the adoption of the final produce rule as a 
uniform public/private standard. Citing concerns that farms are 
suffering from ``audit fatigue'' due to the multitude of requirements 
already in place from handlers, retailers, and state authorities, these 
comments urge FDA to facilitate standardization of produce safety 
requirements and third-party audits.
    (Response) FDA is aware of the multitude of audit programs with 
varying requirements and the associated burden that this places on 
farms. The produce safety regulation represents science-based minimum 
standards for the safe production and harvesting of produce to minimize 
the risk of serious adverse health consequences or death. We understand 
that, as of the publication of this document, many of the widely used 
food safety schemes and programs will be considering whether and how to 
revise their provisions in light of the requirements of FDA 
regulations, including this produce safety regulation and our other new 
FSMA regulations. We expect to continue to work in collaboration with 
stakeholders, including the buyer community, as we move forward in 
implementing this rule.
    (Comment 36) One comment requests FDA to provide a safe harbor 
exemption for contracts and from torts when produce is not delivered 
due to demonstrated food safety concerns.
    (Response) We are not establishing requirements of the type 
suggested by this commenter. We do not believe it would be appropriate 
for FDA to dictate, or to invalidate, the specific aspects of contract 
terms between private parties that the commenter asks us to regulate in 
this rule. We do not discourage private parties from including ``safe 
harbor'' provisions such as those described by the commenter in their 
agreements, but we decline to require or otherwise establish them. In 
addition, we note that section 301(a) of the FD&C Act already prohibits 
the introduction or delivery for introduction of adulterated food into 
interstate commerce. Tort law duties are outside the scope of this 
rulemaking.

V. Final Qualitative Assessment of Risk

    In the 2013 proposed produce safety rule, we discussed the findings 
of a draft qualitative assessment of risk (``the draft QAR'') of 
hazards related to produce production and harvesting that we conducted 
to inform the development of our proposed regulatory approach. The 
draft 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?
    As indicated in the 2013 proposed produce safety rule, the draft 
QAR was peer reviewed in April, 2013. We considered peer reviewers' 
comments as well as public comments received in response to the 
proposed produce safety rule, and finalized the QAR. We consider 
changes made from the draft QAR to the final QAR, such as adding a 
sensitivity analysis regarding the scoring system used in the draft QAR 
and updating the datasets for outbreaks and farm investigations to 
include data through 2014, to have improved the robustness of the QAR. 
We provide a brief summary of conclusions of the QAR in the paragraphs 
that follow. For the complete QAR and our responses to comments 
received, see (Ref. 29) (Ref. 42), respectively. Key conclusions from 
this assessment are: (1) Produce can be contaminated with biological 
hazards, and the vast majority of produce-related illnesses are 
associated with biological hazards; (2) the known 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; (3) 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; (4) 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; and (5) 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, thus, may 
decrease the likelihood of exposure of consumers to contamination.
    Hazards of concern in produce--The scientific evidence from 
outbreaks, surveys and published literature establishes that human 
pathogens (e.g., Salmonella, pathogenic E.coli, Shigella, and 
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 
(see also section IX.A.3 of this document).

[[Page 74376]]

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:
    [ssquf] Crops where the harvestable portion grows in the ground;
    [ssquf] Row crops where the harvestable portion grows on or near 
the ground;
    [ssquf] Crops where the harvestable portion grows above the ground;
    [ssquf] Crops where the harvestable portion grows on trees, high 
above the ground; and
    [ssquf] 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.
    The QAR also identifies certain data gaps and research needs that 
would reduce our uncertainty in understanding how produce becomes 
contaminated and how that contamination contributes to risk during 
growing, harvesting, and postharvest activities. Areas for research 
needs identified in the QAR are origins of pathogens in the farm 
environment; survival and distribution of pathogens in the farm 
environment, specifically in animals, soils, water; transfer of 
pathogens to produce; survival and growth of pathogens on produce; and 
prevalence and levels of pathogens in produce that cause illness.
    We conclude the QAR advances our ability to describe, in a 
systematic manner, the current state of our knowledge about the 
likelihood of illness associated with produce and the likely routes of 
contamination from on-farm activities. It provides a framework for 
integrating and evaluating the scientific knowledge related to public 
health and can be used in support of regulatory decisions in the 
implementation of section 419 of the FD&C Act.
    In the 2013 proposed rule, we also provided our tentative 
conclusions of a quantitative risk assessment to estimate the predicted 
effectiveness of our proposed requirements related to irrigation water 
with respect to one example commodity, i.e., fresh-cut lettuce, and one 
example pathogen, i.e., enterohemorrhagic E. coli (EHEC) (Ref. 43). We 
noted that the quantitative risk assessment document was being peer-
reviewed, and we would consider peer reviewers' and public comments in 
finalizing the quantitative risk assessment and the 2013 proposed rule.
    However, taking into account public comments received in response 
to the 2013 proposed rule, in the supplemental notice, we proposed 
revised requirements for agricultural water, including those for 
irrigation water. To inform our revised proposed requirements, we 
conducted two new separate analyses: (1) An analysis of existing 
recommendations and standards related to water quality to determine 
whether and how they may be used to develop appropriate microbial 
quality criteria for water used during growing of produce (other than 
sprouts) using a direct water application method (Ref. 44); and (2) an 
evaluation of decay rates of microorganisms on produce to determine 
whether a decay rate between irrigation and harvest could be identified 
and, if so, identify an appropriate decay rate (Ref. 45). We relied on 
the conclusions derived from these new analyses to support our revised 
proposed requirements for agricultural water quality in proposed Sec.  
112.44. In this rule, we are finalizing those proposed requirements, 
with revisions, consistent with our updated supporting analyses (see 
section XIII of this document).
    Because the quantitative risk assessment of fresh-cut lettuce cited 
in the 2013 proposed rule pre-dates our revised proposed requirements 
in the supplemental notice, and because we continue to rely on the new 
analyses to finalize our proposed requirements, we are not taking 
further action to finalize the quantitative risk assessment of fresh-
cut lettuce cited in the 2013 proposed rule.

VI. Comments on Non-Biological Hazards

    In the 2013 proposed rule, FDA tentatively concluded that the 
produce safety regulation 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 (78 FR 3504 at 3524). FDA noted that the frequency and nature 
of non-biological 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. We requested comment on this 
approach, and specifically, on whether there are procedures, practices 
or processes that are reasonably necessary to prevent the introduction 
of known or reasonably foreseeable non-biological hazards into produce 
or otherwise to provide reasonable assurances that produce is not 
adulterated under section 402 of the FD&C Act. After considering 
comments, we are finalizing this rule, as proposed, with its scope 
limited to biological hazards.
    Although in the 2013 proposed rule, we referred to radiological 
hazards separately from chemical hazards, we believe that radiological 
hazards have been considered in the past as chemical hazards and, 
therefore, we use the phrase ``chemical (including radiological)'' 
throughout this rule. This reference to radiological hazards as a 
subset of chemical hazards is consistent with how these hazards are 
considered in the PCHF regulation (see definition of ``hazard'' in 
Sec.  117.3).
    (Comment 37) Several comments generally agree with our proposed 
approach to focus on biological hazards, and state that food safety 
resources should be allocated where public health is best served by 
limiting the scope of the rule to biological hazards. These comments 
agree with FDA that there are already sufficient regulatory controls on 
the use of agricultural chemicals in the United States, as evidenced by 
FDA's own historical data. One comment states that farms are already 
regulated at both the State and federal levels in their use of 
agricultural chemicals, and this

[[Page 74377]]

should not be duplicated. Comments also maintain that most produce 
farms have already implemented sufficient controls to minimize the 
likelihood of physical hazards reaching consumers; e.g., washing, 
visual sorting, and mechanical separation devices (such as gaps in 
rollers) to remove potentially harmful objects from produce. In 
addition, comments note that physical hazards rarely, if ever, present 
a risk of severe adverse health consequences or death.
    (Response) FDA is finalizing the produce safety regulation with the 
scope limited, as proposed, to biological hazards and science-based 
standards necessary to minimize the risk of serious adverse health 
consequences or death associated with biological hazards. As we noted 
in the 2013 proposed rule, although the potential for physical or 
chemical (including radiological) contamination of produce exists, we 
do not believe that a new regulatory regime is necessary to address 
those hazards. In a reference memorandum that accompanied the 2013 
proposed rule (Ref. 46), FDA provided an overview of the non-biological 
agents that are reasonably likely to occur in produce at the farm and 
capable of causing adverse health effects. FDA identified the hazards 
using relevant sources, such as scientific literature and recall data. 
Our analysis led us to conclude that non-biological hazards associated 
with produce rarely pose a risk of serious adverse health consequences 
or death for individuals that would consume the product. This is 
because physical or chemical (including radiological) hazards in 
produce either: (1) Occur only rarely at levels that can pose a risk of 
serious adverse health consequences or death (e.g., radiological 
contamination as a result of a nuclear power plant accident); (2) occur 
with greater frequency, but rarely at levels that can pose a risk of 
serious adverse health consequences or death (e.g., pesticide or 
mycotoxin residues); or, (3) occur infrequently and usually do not pose 
a risk of serious adverse health consequences or death (e.g., physical 
hazards). We have also updated our analysis to consider hazards from 
food allergens associated with produce (Ref. 47). No comments included 
data or information suggesting that we should adjust these conclusions 
about hazard severity and frequency.
    FDA continues to routinely monitor chemical and pesticide residues 
through its regulatory monitoring programs, with an emphasis on RACs 
and foods consumed by infants and children (Ref. 48). We continue to 
believe that current programs, such as FDA monitoring, EPA registration 
of pesticides, and State and industry efforts are sufficient to keep 
these hazards under control. In addition, our focus on biological 
hazards is consistent with the recommendations in the Codex Guide, 
which pay particular attention to minimizing microbial hazards and 
address physical and chemical hazards only in so far as these hazards 
relate to good agricultural and manufacturing practices (Ref. 22).
    It is also important to note that potential contamination of 
produce from physical or chemical (including radiological) hazards will 
continue to be covered under the applicable provisions of the FD&C Act 
and implementing regulations. Under section 402(a)(1) of the FD&C Act, 
a food is adulterated if it bears or contains any added poisonous or 
deleterious substance which may render it injurious to health, and such 
substances may include or otherwise result from physical and chemical 
(including radiological) contamination.
    (Comment 38) One comment notes that food allergens, which are 
chemical hazards, are rarely introduced in the growing and handling of 
intact produce, except when the produce itself is a food allergen 
(i.e., tree nuts and peanuts). Another comment refers to the practice 
among some small farms of using milk to manage downy mildew, and 
expresses concern with the introduction of food allergens into produce. 
This commenter requests that FDA forbid the use of allergens in contact 
with produce, regardless of the size of the farm or the type of crop.
    (Response) The Food Allergen Labeling and Consumer Protection Act 
of 2004 (FALCPA) (Pub. L. 108-282) addresses, among other issues, the 
labeling of foods that contain major food allergens. Raw agricultural 
commodities such as fruits and vegetables in their natural state are 
not within the scope of FALCPA. However, allergen hazards associated 
with the growing, harvesting, packing, or holding of produce rarely 
occur. A review of our recall data from 2004 to 2014 shows that there 
were no recalls associated with allergens and produce commodities in 
their RAC form (Ref. 47). As with other chemical hazards associated 
with produce, we do not believe that the incidence of food allergens as 
a hazard associated with growing, harvesting, packing, or holding of 
produce warrants adoption of a new regulatory scheme.
    (Comment 39) Some comments argue that the language of FSMA means 
that the produce safety rule should cover physical and chemical 
(including radiological) hazards.
    (Response) We disagree. Focusing the produce safety regulation on 
biological hazards is consistent with section 419(c)(1)(A) of the FD&C 
Act, which 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].'' This language provides FDA with discretion to 
determine what procedures, processes, and practices are ``reasonably 
necessary'' for the purposes identified in the statute with respect to 
the identified types of hazards.
    As discussed previously, we carefully considered different types of 
hazards, and determined that 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. There is also no pre-existing federal 
regulatory requirement directed at minimizing the risks presented by 
biological hazards in produce. Thus, we conclude it is reasonably 
necessary to set forth controls to prevent the introduction of 
biological hazards into produce, and to provide reasonable assurances 
that the produce is not adulterated under section 402 of the FD&C Act 
on account of biological hazards.
    On the other hand, FDA's analysis of the potential for physical and 
chemical (including radiological) hazards to contaminate produce and 
cause serious adverse health consequences or death, as well as the 
adequacy of existing regulatory programs to address such potential, did 
not demonstrate that additional regulation was reasonably necessary. We 
conclude that it is not reasonably necessary to establish controls for 
physical or chemical (including radiological) hazards in this 
rulemaking in light of the severity and frequency of occurrence of 
these hazards in produce, and the existing regulatory structures that 
apply to these hazards.
    (Comment 40) Several comments argue for an approach that includes a 
broader range of hazards, in light of local, regional or country-wide

[[Page 74378]]

differences. A number of comments maintain that the rule should apply 
the principles of the Hazard Analysis and Critical Control Point 
(HACCP) to identify risks. One comment argues that the general 
requirement in Sec.  112.11 should apply to all known or reasonably 
foreseeable hazards. Several comments provide example scenarios where 
they believe biological, chemical, or physical hazards could represent 
a significant food safety hazard on a farm. For example, one comment 
argues that water is a potential source of chemical contaminants so the 
requirements for water should cover these hazards. Other comments 
maintain that if a covered farm's land was previously used for another 
activity that may have contaminated the soil with chemical hazards, the 
covered farm should be required to take measures (such as collecting 
and analyzing soil samples for residues) to prevent the introduction of 
the chemical hazards into or onto produce. Other comments express 
concern about the use of sewage sludge that can carry a high load of 
heavy metals and other chemicals (such as drug residues).
    (Response) While FDA recognizes that specific scenarios are likely 
to arise in which physical or chemical (including radiological) hazards 
present risks of contaminating produce on farms, we conclude that it is 
not reasonably necessary to establish required controls for such 
hazards in this rulemaking, in light of the severity and frequency of 
occurrence of these hazards in produce, and the existing regulatory 
structures that apply to these hazards. FDA agrees that it is desirable 
for individual operations to consider their particular circumstances 
and address relevant hazards. As discussed in section VII of this 
document, we believe that one way to do this is through the voluntary 
use of farm-specific operational assessments and food safety plans. 
Although we are not requiring that covered farms conduct operational 
assessments or develop food safety plans, we continue to believe that 
such assessment can help farms identify and take measures that may be 
prudent for their individual operations to prevent the introduction of 
known or reasonably foreseeable hazards, including any non-biological 
hazards. Implementation of food safety plans that are developed based 
on operational assessments can help farms to be more proactive and 
effective in protecting the safety of their produce. We also 
acknowledge that existing guidances on produce safety, including the 
GAPs Guide, the Codex Guide, and Industry Harmonized GAPs (Ref. 49) 
(Ref. 50), all recommend that a farm tailor its food safety practices 
to the practices and conditions at its individual operation.
    Even on a voluntary basis, FDA believes that a full-fledged HACCP 
approach would not necessarily be appropriate at the farm level 
because, although there are practices to reduce contamination of 
produce on the farm, there are typically few critical control points. 
However, many of the principles of HACCP can still be applied, such as 
an assessment of risk and the development of a food safety plan based 
on that assessment.
    As discussed previously, we continue to believe that current 
programs are sufficient to keep these hazards under control. We also 
emphasize that contamination of produce with physical or chemical 
(including radiological) hazards will continue to be covered under 
applicable provisions of the FD&C Act and implementing regulations, and 
adulterated food may be subject to enforcement action by FDA, as 
appropriate.
    (Comment 41) Citing the increased importance of urban agriculture 
and urban farming, one comment maintains that FDA failed to consider 
the contamination of urban properties in the United States with 
chemical (including radiological) hazards, as well as similar 
contamination of agricultural lands in other countries used for growing 
produce, and suggests addressing this issue, at a minimum in guidance.
    (Response) We have and will continue to consider agency action, as 
appropriate, to address the issues associated with risks presented to 
produce by urban farming, heavy metals, and other non-biological 
hazards. For example, the GAPs Guide addresses previous land use 
including animal grazing, chemical application, and toxic spills. In 
addition, at the request of some foreign audiences, the JIFSAN 
International GAPs Train-the-Trainer program (Ref. 51) has been updated 
to include information about the importance of previous land use due to 
the potential for contamination with both biological and non-biological 
hazards and a section on EPA requirements for pesticide use.
    (Comment 42) One comment notes that while other regulatory and non-
regulatory control programs may indirectly control physical and 
chemical food safety hazards, the fact that those programs are not 
necessarily intended to deliver food safety outcomes means there may be 
gaps which a food safety focused regulation may need to address. 
Another comment states that even though pesticide use does not cause 
immediate adverse health consequences or death, food safety is still a 
concern. This comment urges FDA to consider certain research on the 
public health risk associated with widespread use of commercial 
pesticides and herbicides built up in our environment, watershed, and 
food supply. The comment mentions the 2010 report by the President's 
Cancer Panel and other bodies, which the commenter believes documents 
growing evidence on the negative impacts of agricultural chemical use 
on public health. Other comments express concern over other chemical 
hazards, such as those used in fields, and state that these chemicals 
can have harmful effects on both health and the environment.
    (Response) That physical or chemical (including radiological) 
hazards are not addressed in this regulation does not mean that these 
hazards do not exist or that there is no potential for contamination of 
produce from these hazards. It also does not mean that these hazards 
are not included in a comprehensive food safety regulatory strategy. 
Rather, we believe the frequency and nature of physical and chemical 
(including radiological) hazards occurring in produce and the existing 
regulatory programs are such that promulgation of a new regulatory 
regime is not reasonably necessary to minimize the risk of serious 
adverse health consequences or death associated with these hazards.
    There are effective governmental control programs in place in the 
United States to assure generally that unlawful pesticide residues are 
unlikely to occur. For pesticides, these controls include pesticide 
registration, applicator licensure, and government sampling and 
enforcement programs. For example, the Federal Insecticide, Fungicide 
and Rodenticide Act (7 U.S.C. 136-136y) (FIFRA) authorizes EPA to 
regulate the use and sale of pesticide to protect human health and to 
preserve the environment. As part of this evaluation, EPA must ensure 
with a reasonable certainty that no harm will result from the legal 
uses of the pesticide. EPA's evaluation considers, among other things, 
the combined risk from that pesticide from all non-occupational sources 
(including uses on food), and whether there is an increased sensitivity 
from exposure of the pesticide to infants and children (Ref. 52). 
Pesticide tolerances set by EPA are enforced by FDA for most foods and 
by USDA's Food Safety and Inspection Service (FSIS) for meat, poultry, 
and some egg products. As mentioned previously, FDA also routinely 
monitors for chemicals, pesticide residues, metals

[[Page 74379]]

and radionuclides through its regulatory monitoring programs, with an 
emphasis on RACs and foods consumed by infants and children (Ref. 48). 
Other federal and state programs, too, monitor chemical hazards in food 
directed at food safety. For example, AMS operates the Pesticide Data 
Program, which collects and analyzes samples for pesticide residues in 
food, and data from this program is utilized by USDA, FDA, EPA, and 
other groups (Ref. 53). Individual States also have programs to 
routinely monitor for non-microbiological hazards in foods.
    With respect to the 2008-2009 President's Cancer Panel ``Reducing 
Environmental Cancer Risk'' (Ref. 54), we note that, among other 
conclusions, the Panel recommends that consumers can reduce exposure to 
pesticides in food by selecting food grown without pesticides or 
chemical fertilizers and washing conventionally grown produce to remove 
residues. This recommendation is consistent with FDA and the 
Partnership for Food Safety Education advice to consumers that produce 
should be washed immediately before preparation and consumption (Ref. 
38) (Ref. 55).
    (Comment 43) One comment points out that a recent United States 
Government Accountability Office (GAO) report criticized FDA for its 
lack of pesticide residue testing on food. This commenter asks FDA to 
adopt better chemical safety standards for produce.
    (Response) In October, 2014, the GAO released a report entitled 
``Food Safety--FDA and USDA Should Strengthen Pesticide Residue 
Monitoring Programs and Further Disclose Monitoring Limitations'' (GAO-
15-38). In that report, GAO discusses its review of federal oversight 
of the foods regulated by FDA, FSIS, and AMS, and makes a number of 
recommendations to further enhance the pesticide monitoring programs of 
the two agencies. As noted in that report, FDA has already undertaken 
certain actions to enhance its program. For example, FDA has increased 
its monitoring of pesticide residues by taking actions consistent with 
the GAO recommendations and increased the scope of its testing program. 
FDA uses AMS's Pesticide Data Program, which generates national 
statistically-valid data, to target commodities for testing. FDA also 
has an ongoing effort as part of its pesticide residue monitoring 
program to evaluate the effectiveness of regulatory actions in 
preventing violations.
    (Comment 44) Some comments maintain certain biological soil 
amendments contain chemical hazards that FDA should address in this 
rule. For example, one comment states that animal manure from animal 
production facilities can contain heavy metals, such as arsenic, zinc, 
and copper; and animal drug residues, including antibiotics that raise 
human health concerns. Some comments point out that industry commodity-
specific food safety guidelines and the NOP prohibit the use of both 
raw human waste and biosolids, as these materials present a risk of 
introducing pharmaceuticals and heavy metals. Some comments also state 
that research on the risks presented by pharmaceuticals present in 
produce-growing soils that have been treated with biosolids, and any 
subsequent uptake into plants, is in its infancy.
    (Response) As discussed previously, FDA's analysis of the potential 
for chemical hazards (including heavy metals and drug residues) to 
contaminate produce and cause serious adverse health consequences or 
death, as well as the adequacy of existing regulatory programs to 
address such potential, did not demonstrate that additional regulation 
was reasonably necessary. We conclude that it is not reasonably 
necessary to establish controls for physical or chemical (including 
radiological) hazards in this rulemaking in light of the severity and 
frequency of occurrence of these hazards in produce, and the existing 
regulatory structures that apply to these hazards. Therefore, we are 
limiting the scope of this rulemaking to biological hazards.

VII. Comments on Farm-Specific Food Safety Plans

    We discussed farm-specific operational assessments and food safety 
plans in section IV.F of the 2013 proposed produce safety rule. We 
tentatively decided not to require farms to conduct operational 
assessments or to develop food safety plans. However, we explained that 
operational assessments and food safety plans have a prominent place in 
ensuring produce safety and recommended that farms do so, because this 
could help farms be more effective in protecting the safety of their 
produce. We requested comment on whether we should require that some or 
all covered farms 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. After 
considering comments, we are finalizing this rule as proposed, with no 
requirement for a covered farm to conduct an operational assessment or 
to develop a farm-specific food safety plan, although we recommend that 
farms do so.
    (Comment 45) Several comments recommend that FDA require all 
covered farms to perform operational assessments and/or develop a 
written food safety plan. These comments state that conducting an 
assessment of likely hazards that could occur on the farm can help 
farmers identify potential situations which could lead to contaminated 
food, helping allocate resources efficiently. Some comments indicate 
that this requirement is appropriate regardless of the size of an 
operation or volume of sales and note that many farms already operate 
using well-developed, monitored, and maintained food safety plans. Some 
comments also state that operational assessments would also provide 
inspectors--whether State or federal--with a mechanism for 
understanding the particular hazards the farm believes it is 
mitigating. In addition, some comments maintain that many farms 
currently develop and use food safety plans under certain industry 
programs. One comment supports a requirement for a food safety plan, 
but indicates that the food safety plan should be used as a tool to 
advance food safety practices rather than as an enforcement tool to 
determine if a farm is non-compliant.
    Conversely, many comments oppose any FDA requirement for farms to 
develop food safety plans. Although acknowledging that some farms may 
perform operational assessments or develop food safety plans and farms 
may benefit from food safety plans, these comments argue that FSMA does 
not authorize FDA to require farms to perform operational assessments 
or develop food safety plans. These comments believe that such a 
requirement established in regulation would be unreasonable; overly 
burdensome, particularly for small farmers; would decrease the 
flexibility of the produce safety rule; and may affect current State 
requirements or industry recommendations. Other comments find a 
requirement for a farm-specific food safety plan unnecessary because, 
according to these commenters, FDA has already performed a hazard 
analysis for most operations by identifying in the produce safety 
proposed rule the hazards reasonably likely to occur, and communicated 
that future guidance will include additional information on control 
measures that operations can use to minimize the likelihood of those 
hazards affecting produce.
    (Response) In our guidances to industry, FDA has previously 
recommended the use of farm-specific

[[Page 74380]]

food safety plans. For example, in the GAPs Guide, we stated that the 
recommendations in that guide would be most effective if farms took 
them and tailored them to their individual operations (Ref. 14). Since 
publication of the GAPs Guide, the principle of tailoring practices to 
an individual operation has evolved into using an operational 
assessment and developing an on-farm food safety plan that is specific 
to that operation, based on the assessment. Food safety plans have 
become an important component in a number of existing programs and 
guidances and, as several commenters noted, tools are currently 
available to fit a variety of operations. FDA's draft commodity-
specific guidances, too, include draft recommendations to develop and 
maintain written food safety plans and standard operating procedures 
for areas such as handling and storage practices; field, building, and 
vehicle cleaning and sanitation; and employee training programs (Ref. 
56) (Ref. 57) (Ref. 58).
    FDA agrees that all farms, irrespective of the size of the 
operation, the commodities they grow, the practices they follow, or 
their status with respect to coverage under the produce safety rule, 
could benefit from performing an operational assessment and having a 
food safety plan, and we encourage all farms to do so. A site-specific 
assessment can help a farm tailor practices to their specific 
operation. We agree that assessments and plans should be commensurate 
with the size and scope of an operation and that different assessment 
tools may be best suited for different operations, e.g., by commodity, 
size, or region.
    We continue to believe, however, that requiring covered farms to 
conduct an operational assessment and develop a food safety plan, 
particularly at the level required for hazard analysis and development 
of a food safety plan in our juice HACCP regulation (i.e., the Hazard 
Analysis and Critical Control Point Systems regulation in 21 CFR part 
120) and our seafood HACCP regulation (i.e., the Fish and Fishery 
Products regulation in 21 CFR part 123), or prescribed by section 418 
of FSMA for food facilities, is not warranted as a mandatory 
requirement for the safe production of covered produce. The statutory 
direction in section 419 is for FDA to establish science-based minimum 
standards, including procedures, processes, and practices that are 
reasonably necessary to prevent introduction of hazards and provide 
reasonable assurances produce is not adulterated. As discussed in the 
2013 proposed rule, relevant documents on produce safety, such as the 
GAPs Guide, industry commodity-specific guidelines for melons, 
tomatoes, leafy greens, and green onions (Ref. 40) (Ref. 59) (Ref. 60) 
(Ref. 61), the CA LGMA, the AZ LGMA, the Association of Food and Drug 
Officials' (AFDO) Model Code of Practice for the Production of Fresh 
Fruits and Vegetables (the AFDO Model Code) (Ref. 62), the Codex Guide, 
and Industry Harmonized GAPs, all recommend that a farm tailor its food 
safety practices to the practices and conditions at its individual 
operation. We believe the most appropriate approach for the produce 
safety regulation is to establish the standards that are described in 
part 112. While operational assessments and food safety plans are 
valuable tools, we believe they may be more than a minimum standard and 
more than what is reasonably necessary for us to require to achieve the 
statutory purposes. Therefore, we are not establishing a requirement 
for farms to conduct operational assessments or to develop food safety 
plans.
    FDA agrees that, in issuing the produce safety regulation, FDA has 
essentially performed a hazard analysis and established what could be 
characterized as a baseline or minimum food safety plan for covered 
farms. We also agree the process of conducting an operational 
assessment and developing a plan could be a useful exercise to help 
many farms, whether they are subject to the rule or not, to more 
closely examine their operations and identify potential risks along 
with ways those risks might best be reduced. Therefore, we encourage 
farms to develop a food safety plan.
    In response to comments urging education and outreach efforts, FDA 
notes that the PSA working groups identified operational assessments 
and food safety plans as being valuable components of an on-farm food 
safety system and have developed a food safety plan training module as 
part of their training curriculum. The PSA is also planning an optional 
2-day workshop that can be added to their basic training on the 
assessment and food safety plan development process. We also 
acknowledge the efforts of other non-governmental organizations, farm 
groups, and private businesses that are currently working with farmers 
on development of food safety plans.
    Finally, in response to the comment suggesting that food safety 
plans should not be used in enforcement, we note that we are 
recommending, but not requiring, that farms have a food safety plan.
    (Comment 46) Some comments suggest that FDA should provide in 
guidance documents model food safety plans for use by farms that are 
not covered by the rule or that are eligible for the qualified 
exemption. Some comments state that they expect the produce safety 
regulation to lead consumers and commercial buyers to demand that all 
produce farms are following practices that reduce food safety risks, 
such that farms that are not required to comply with the rule would be 
at a disadvantage in the market.
    (Response) As discussed previously, FDA continues to recommend 
operational assessments and food safety plans for all farms, including 
those not required to comply with the rule, and we intend to address 
this further in guidance.
    (Comment 47) Some comments suggest that FDA should stipulate that 
farms eligible for the qualified exemption that have food safety plans 
would have protection from having that exemption revoked. According to 
these commenters, if these farms receive additional incentives to 
develop food safety plans, it would help prevent them from creating 
conditions that could cause their exemption to be revoked, and assist 
them in defending themselves, should the FDA determine that a food 
borne illness was caused by material conduct or conditions linked to 
their operation. Another comment states that FDA guidance and model 
food safety plans should encourage farms to record information that 
would be useful in the event of a challenge to their exemption.
    (Response) We encourage the use of food safety plans by all farms, 
including those that are not covered by the produce safety regulation 
as well as those that are eligible for a qualified exemption and 
subject to certain modified requirements. We also refer you to the 
discussion in section XXIII.A of this document where we discuss the 
circumstances under which FDA may withdraw a qualified exemption, in 
accordance with Sec.  112.201. As established in Sec.  112.201(b)(1), 
before FDA issues an order to withdraw your qualified exemption, FDA 
may consider one or more other actions to protect the public health and 
prevent or mitigate a foodborne illness outbreak, including a warning 
letter, recall, administrative detention, refusal of food offered for 
import, seizure, and injunction. Although we are not providing any 
categorical limitation on withdrawal of qualified exemptions based on 
existence of a food safety plan, we believe that food safety problems 
are less likely to happen in an operation that has

[[Page 74381]]

thoughtfully assessed its risks, identified potential hazards, and 
taken steps to mitigate the hazards identified.
    (Comment 48) One comment suggests that the produce safety rule 
could be structured to allow farms to comply either by following the 
requirements as proposed or by developing, documenting, implementing, 
monitoring, and maintaining a food safety plan based on a comprehensive 
hazard analysis that utilizes the same principles as HACCP in the 
proposed human preventive controls rule. The commenter explains that, 
instead of following the prescribed standards, a covered farm would 
have the option to demonstrate and document the identification of its 
risks through its unique hazard analysis, and maintain adequate 
scientific data or information to support its resultant approach and 
conclusion that its food safety plan would provide the same level of 
public health protection as following the set of prescribed rules, 
similar to the alternative provisions permitted under proposed Sec.  
112.12.
    (Response) As noted in response to Comment 45, we do not believe 
requiring covered farms to conduct an operational assessment and 
develop a farm-specific food safety plan, particularly at the level 
required for hazard analysis and development of a food safety plan in 
our juice and seafood HACCP regulations, or prescribed by section 418 
of FSMA for food facilities, is warranted to meet the statutory 
direction in section 419 to establish ``minimum science-based 
standards'' for produce safety and ``procedures, processes, and 
practices that the Secretary determines to be reasonably necessary'' to 
meet the statutory goals of preventing introduction of known or 
reasonably foreseeable hazards and providing reasonable assurances 
produce is not adulterated.
    We agree that an operational assessment and written food safety 
plan could be useful to a farm to identify whether and how an 
alternative approach to an FDA-established requirement (as permitted 
under Sec.  112.12) could be applied to the specific operations at the 
farm. Note, however, section Sec.  112.12 provides for the use of 
alternatives for only certain specified requirements of part 112, and 
not for all of the requirements of part 112. FDA does not agree with 
the commenter's suggestion that we should allow covered farms to choose 
between complying with the requirements of part 112 and conducting an 
operational assessment and developing a food safety plan based on such 
assessment. Such an approach would be akin to permitting the use of an 
alternative to every one of the provisions of part 112, which FDA has 
determined is not an appropriate approach (we refer you to the 
discussion in section X.C of this document). The provisions FDA is 
establishing in this rule are those that FDA has determined are 
appropriate to require of all covered farms when they are applicable to 
the farms' operations. Where FDA believes that alternative approaches 
may reasonably provide the same level of public health protection, we 
have provided an option to use an alternative in Sec.  112.12.
    (Comment 49) One comment suggests that national and regional crop 
associations should have the flexibility to add 
commodity[hyphen]specific and risk-based standards to FDA-prescribed 
standards to fit their own crop(s), as necessary. This comment 
maintains that such an approach would allow farms to continue using 
commonly accepted food safety practices that they have determined to be 
the best approach for their crop(s). This comment refers to mandatory 
food safety and recall plans within a food safety program as examples.
    (Response) Part 112 does not prohibit or otherwise preclude covered 
farms from developing and implementing farm-specific food safety plans, 
including continued use of food safety plans that may be currently in 
place, as long as the farms also comply with the provisions of part 
112. The provisions for use of alternatives (in accordance with Sec.  
112.12) and use of variances (in accordance with subpart P of part 112) 
provide flexibility for the use of measures that are tailored to 
specific commodities and conditions, either in addition to the FDA-
established science-based minimum standards in part 112, or in lieu of 
them where allowed under the rule. FDA anticipates that its guidance 
may also contain additional commodity-, region- and 
practice[hyphen]specific, risk-based recommendations, as needed and 
appropriate, to assist covered farms in following best practices 
appropriate to their crop(s), region and practices. In developing such 
guidance, we intend to take existing guidance and produce safety 
programs into consideration, similar to our development of draft 
commodity-specific guidances for melons, tomatoes, and leafy greens.

VIII. Comments Related to Foreign Farms

    In the 2013 proposed produce safety rule, we noted that proposed 
part 112 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. We also noted our intention to provide 
equal treatment for foreign and domestic farms and to identify areas 
for outreach and technical cooperation to help foreign farms understand 
the rule's applicability to them.
    We received a number of comments regarding foreign farms from both 
domestic and foreign stakeholders that addressed various aspects of the 
produce safety regulation. For example, comments addressed issues 
related to coverage of farms (subpart A), personnel training (subpart 
C), variances (subpart P), and compliance and enforcement (subpart Q), 
which we considered in the sections of this document where the relevant 
subparts of part 112 are discussed. In this section, we summarize and 
respond to comments that address general and cross-cutting issues 
related to foreign farms.
    (Comment 50) Several comments recognize the need to apply the rule 
equally to domestic and foreign farms that sell produce in the United 
States market, but believe that the rule may place domestic farmers at 
an economic disadvantage. These comments argue that enforcement of the 
regulation will inevitably be more stringent on United States farms 
than on foreign farms, citing limitations of FDA resources and FDA 
jurisdiction over foreign farms.
    (Response) This rule applies equally to domestically-produced and 
imported produce. Covered entities in the United States and abroad must 
adhere to the same standards. As such, we do not agree that it will 
disadvantage United States farms as compared to foreign farms.
    With respect to enforcement, FDA intends to use the resources at 
its disposal to ensure that both domestic and foreign producers are 
following the requirements of the rule. As discussed in section XXII of 
this document, our strategy to ensure the safety of produce, both 
domestically-produced and originating from foreign farms, will focus on 
education, training, and guidance to achieve compliance. This will 
include outreach to foreign governments. We will also work to provide 
education and assistance in local languages to reach farmers exporting 
covered produce into the United States, including by working with 
organizations and other sources of information that are familiar and 
accessible to the produce farming community (such as alliances, 
international organizations, universities, trade associations, foreign 
partners, JIFSAN, and federal agencies (such as USAID and USDA), among 
others).

[[Page 74382]]

    Inspections will also play a key role. Under the FD&C Act, FDA has 
authority to inspect produce farms and can take enforcement action when 
needed, such as to prevent significant hazards from entering the food 
supply or in response to produce safety problems. While FDA is not in a 
position to inspect every foreign farm that produces food for 
consumption in the United States, the inspections FDA is able to 
conduct will be bolstered by other efforts, such as the final FSVP rule 
establishing subpart L of 21 CFR part 1 (hereafter referred to as ``the 
FSVP regulation'') (published elsewhere in this issue of the Federal 
Register). The FSVP regulation establishes requirements for importers 
to verify that imported food (including produce) is produced in 
compliance with FDA food safety regulations (including the produce 
safety regulation) or is produced in accordance with processes and 
procedures that ensure the same level of public health protection as is 
required in the United States.
    (Comment 51) Several comments stress the importance of publishing 
the Produce Safety rule concurrently with the import-related FSMA 
rules, such as the FSVP and third-party certification rules, in order 
to ensure consistent regulation of domestic and imported produce.
    (Response) In finalizing this rule, FDA has considered issues 
related to the FSVP and third-party certification rules. Section 301 of 
FSMA directs us to establish foreign supplier verification programs for 
importers of food. In addition, section 307 of FSMA directs us to 
establish a system for the recognition of accreditation bodies that 
accredit third-party auditors to certify that eligible entities meet 
certain requirements. In the rulemakings establishing the FSVP 
regulation and the third-party certification regulation, published 
elsewhere in this issue of the Federal Register, FDA explained how the 
supplier verification requirements and third-party certification 
requirements in those rules relate to farms that are subject to the 
produce safety regulation and those that are not subject to the produce 
safety regulation.
    (Comment 52) Several comments argue that the requirements of the 
rule will disadvantage foreign farms as compared to domestic farms. 
Some of these comments argue that the rule is too prescriptive and 
suggest that greater flexibility could be achieved by allowing foreign 
farms to make their own choices about what methods and tools are 
necessary to ensure food safety. These comments also note that foreign 
authorities have a role in enforcing their own requirements regarding 
food safety practices. One comment recommends that FDA not establish 
any requirements related to foreign farms' production practices. 
Instead, the comment asserts that FDA should only verify whether 
articles of produce themselves comply with the FD&C Act, and should 
only check the compliance of produce from farms with a history of non-
compliance.
    (Response) This rule applies equally to domestically-produced and 
imported produce. Covered entities in the United States and abroad must 
adhere to the same standards. As such, we do not agree that it will 
disadvantage foreign farms as compared to domestic farms. The risks 
from imported and domestic produce arise from the same or similar 
pathogens and routes of contamination. Therefore, the requirements that 
we are establishing in part 112 apply equally to these concerns 
wherever they arise.
    We also disagree with comments that suggest that the rule is too 
prescriptive. We have incorporated significant flexibility into our 
requirements, wherever appropriate, by relying on an integrated 
approach that employs various mechanisms (for example, current good 
manufacturing practices, numerical criteria, and monitoring) as 
appropriate to the hazards. This provides sufficient flexibility to 
allow all covered farms, both foreign and domestic, to determine the 
methods and tools necessary to produce safe food as appropriate, taking 
into account the specific practices, procedures, and processes in their 
individual farm operations. We have also provided additional 
flexibility by permitting a foreign government to request from FDA a 
variance from any one or more of the requirements in part 112, under 
certain conditions as described in subpart P of part 112.
    Neither FDA, generally, nor this rule, specifically, imposes any 
restrictions on foreign governments from establishing or enforcing 
their own requirements within their sovereign nations. This rule covers 
produce RACs that are 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. 
This includes produce RACs that are grown domestically for export to 
foreign countries. To the extent a foreign covered farm exports covered 
produce to the United States, such farm must ensure that its production 
of such produce complies with all applicable requirements of part 112. 
Conversely, the requirements of part 112 do not apply to produce that 
is grown, harvested, packed, or held on a foreign farm that is not 
exported to the United States.
    Finally, with respect to the comment about focusing on the produce 
commodity, itself, rather than on production practices, we refer you to 
the discussion in section IV.I of the 2013 proposed rule and section 
III.F of this document, where we explain our conclusion that product 
testing requirements (except under certain circumstances for sprouts) 
would be impracticable. We also refer you to the discussion on 
commodity-specific approaches in section IV.A of this document.
    (Comment 53) Several comments argue that requiring foreign farms to 
adhere to the rule will cause them to incur considerable costs and 
restrict farms from engaging in trade with the United States. Some of 
these comments specifically state that the rule should not impose 
requirements that would act as barriers to trade in conflict with 
United States trade obligations.
    (Response) This rule is fully consistent with United States trade 
obligations. In developing the produce safety standards in part 112, 
and in formulating our implementation strategy (as described under 
subpart Q of part 112), we considered United States trade obligations 
to ensure that the final rule is based on risk and on science, and we 
are applying the same standards to imported and domestic food to ensure 
the safety of the United States food supply.
    (Comment 54) Some comments argue that imported produce should be 
more closely monitored than domestically-grown produce. Some of these 
commenters believe that applying additional oversight to imported 
produce may decrease the number of contamination events and illnesses 
occurring in the United States.
    (Response) This rule covers produce RACs that are 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. This includes produce 
RACs that are grown domestically for export to foreign countries. We 
are not aware of evidence indicating that imported produce contributes 
a disproportionately higher risk of illness to United States consumers 
compared to domestically-grown produce. We expect that compliance with 
the standards in part 112 will reduce the risk of foodborne illness 
associated with the consumption of contaminated produce, whether 
domestic or imported.

[[Page 74383]]

    (Comment 55) One comment asks FDA to clarify the applicability of 
the rule to a foreign farm that harvests produce and ships it to the 
United States in non-consumer containers, where the produce is 
subsequently packaged in retail containers sold to the public.
    (Response) In this example, neither the foreign location of the 
farm nor the packaging/repackaging that occurs in the United States 
affects the status of the foreign farm or its produce under this rule. 
Assuming that the foreign farm is a covered farm, and the produce is 
covered produce, the farm and its produce are subject to this rule.
    (Comment 56) Many comments express the need for FDA to engage 
foreign governments to help them understand what is expected of foreign 
farms under this rule. One comment states that FDA should provide 
training and capacity building programs for foreign governments. 
Another comment requests that FDA provide translations of the 
regulation as well as accompanying guidance documents in order to 
facilitate understanding by both foreign governments and foreign farms, 
and compliance by foreign farms.
    (Response) As noted previously, education, training, and guidance 
will be key components of our strategy to achieve compliance with the 
produce safety regulation, both for domestic and imported produce. 
Specifically, we recognize that some foreign farms may have difficulty 
understanding the applicability of the rule to them, and we will work 
with new and existing partners to identify areas for international 
outreach and technical cooperation to achieve greater understanding. 
Moreover, section 305 of FSMA directs FDA to develop a plan to build 
the capacity of foreign governments with respect to food safety. 
Leveraging and partnerships are important in everything FDA does, and 
even more so with capacity building. FDA recognizes the importance of 
establishing strong relationships and mutual support among all 
stakeholders from farm to table. We will also work to provide education 
and assistance in local languages to reach farmers exporting covered 
produce into the United States, and will work with organizations and 
other sources of information that are familiar and accessible to the 
produce farming community (such the Alliances, international 
organizations, universities, trade associations, foreign partners, 
JIFSAN, and federal agencies (such as USAID and USDA), among others). 
We will work with partners to provide technical assistance to the 
farming community, especially small and very small farms, regarding 
compliance with this rule. We also intend to disseminate guidance 
documents in multiple languages.

IX. Subpart A--Comments on Definitions and General Provisions

    In proposed subpart A of part 112, we proposed to establish 
provisions that establish the scope of, and definitions applicable to, 
this regulation, and which identify who and what is subject to the 
requirements of this part. As proposed, this subpart also described the 
criteria for eligibility for qualified exemptions, and modified 
requirements for those eligible for a qualified exemption from this 
rule. We asked for comment on all provisions in subpart A.
    We are finalizing these provisions with revisions (see Table 4). We 
discuss these changes in this section.

             Table 4--Description of Revisions to Subpart A
------------------------------------------------------------------------
       Final provision                  Description of revisions
------------------------------------------------------------------------
Sec.   112.1(b)(1)...........  --Revisions to the list of examples of
                                fruits and vegetables.
Sec.   112.2(a)(1)--           --Revisions to the list of exempt
 exhaustive list of rarely      commodities based on our updated robust
 consumed raw produce.          analysis using more recent data and
                                information, and considering public
                                comments.
Sec.   112.2(b)--produce that  --Addition of wine and beer as examples
 receives commercial            in Sec.   112.2(b)(1).
 processing.                   --New provisions Sec.   112.2(b)(2), (3),
                                and (4) to require certain disclosure
                                and documentation, and annually obtain
                                certain written assurances.
                               --New provision Sec.   112.2(b)(6)
                                related to entities that provide the
                                written assurances described in Sec.
                                112.2(b)(3)(i) or (ii).
Sec.   112.3(b)--Definition    --Revision to acknowledge that such
 of ``small business'' and      businesses may be subject to only some
 ``very small business''.       requirements of part 112 if the farm is
                                also eligible for qualified exemption.
Sec.   112.3(c)--Definition    --Revision to add ``Agricultural teas are
 of ``agricultural tea''.       soil amendments for purposes of this
                                rule''.
                               --Revision to replace ``humus'' with
                                ``stabilized compost''.
                               --Revision to specify that agricultural
                                teas are soil amendments for the
                                purposes of this rule.
Sec.   112.3(c)--Definition    --Revision to replace ``humus'' with
 of ``biological soil           ``stabilized compost''.
 amendment''.
Sec.   112.3(c)--Definition    --Revision to add animal mortalities as
 of ``biological soil           an example.
 amendment of animal origin''.
Sec.   112.3(c)--Definition    --Revision to replace ``humus'' with
 of ``composting''.             ``stabilized compost''.
Sec.   112.3(c)--Definition    --Revision to reflect new Sec.
 of ``covered activity''.       112.2(b)(6) by adding ``Providing,
                                acting consistently with, and
                                documenting actions taken in compliance
                                with written assurances as described in
                                section 112.2(b) of this part are also
                                covered activities.''
Sec.   112.3(c)--Definition    --Revision to replace ``maturation'' with
 of ``curing''.                 ``final''.
                               --Revision to add ``Curing may or may not
                                involve insulation, depending on
                                environmental conditions.''
Sec.   112.3(c)--Definition    --Revision consistent with changes made
 of ``farm''.                   in PCHF regulation.
Sec.   112.3(c)--Definition    --New definition of ``ground water''
 of ``ground water''.           added, with corresponding changes to
                                definition of ``surface water''.
Sec.   112.3(c)--Definition    --Revision to replace ``humus'' with
 of ``growth media''.           ``stabilized compost''.
Sec.   112.3(c)--Definition    --Revision consistent with changes made
 of ``harvesting''.             in PCHF regulation.
Sec.   112.3(c)--Definition    --Revision to more clearly distinguish
 of ``hazard''.                 ``hazard'' from ``known or reasonably
                                foreseeable hazard'' by replacing ``is
                                reasonably likely to'' with ``has the
                                potential to''.
Sec.   112.3(c)--Definition    --Revision consistent with changes made
 of ``holding''.                in PCHF regulation.
Sec.   112.3(c)--Definition    --Replacing the term ``reasonably
 of ``known or reasonably       foreseeable hazard'' with ``known or
 foreseeable hazard''.          reasonably foreseeable hazard''.
                               --Revision to more clearly distinguish
                                this term from ``hazard''.
                               --Revision to specify that for the
                                purposes of this rule, such hazards are
                                biological.

[[Page 74384]]

 
Sec.   112.3(c)--Definition    --Revision consistent with changes made
 of ``manufacturing/            in PCHF regulation.
 processing''.
Sec.   112.3(c)--Definition    --Revision consistent with changes made
 of ``mixed-type facility''.    in PCHF regulation.
Sec.   112.3(c)--Definition    --Revision to replace the phrase ``when
 of ``monitor''.                applicable'' with ``when required''.
Sec.   112.3(c)--Definition    --Revision to replace ``other than
 of ``non-fecal animal          excreta'' with ``other than manure''.
 byproduct''.
Sec.   112.3(c)--Definition    --Deleted consistent with changes made in
 of ``packaging'' (when used    PCHF regulation.
 as a verb).
Sec.   112.3(c)--Definition    --Revision consistent with changes made
 of ``packing''.                in PCHF regulation.
Sec.   112.3(c)--Definition    --Revision to add ``primarily'' before
 of ``produce''.                ``grown and processed for use as meal,
                                flour, baked goods, cereals and oils''
                                in description of grains.
                               --Revision to replace ``fresh
                                consumption'' in description of grains
                                with ``direct consumption as small, hard
                                fruits or seeds''.
                               --Revision to include ``oilseeds'' as an
                                example of grains, and to include flax
                                seed, rapeseed, and sunflower seed as
                                more specific examples.
                               --Revision to add commas.
Sec.   112.3(c)--Definition    --Revision to add ``or the same Indian
 of ``qualified end-user''.     reservation''.
                               --Revision to move ``The term `consumer'
                                does not include a business'' from under
                                (ii) into a parenthetical phrase within
                                the definition.
Sec.   112.3(c)--Definition    --Revision to refer to adequately
 of ``sanitize''.               treating ``surfaces'' rather than ``food-
                                contact surfaces,'' consistent with
                                changes made in PCHF regulation.
Sec.   112.3(c)--Definition    --Revision to use the term ``stabilized
 of ``stabilized compost''.     compost'' rather than proposed term
                                ``humus'' to better reflect the finished
                                product of composting.
Sec.   112.3(c)--Definition    --Revision to replace ``humus'' with
 of ``soil amendment''.         ``stabilized compost''.
Sec.   112.3(c)--Definition    --Revision to replace ``covered with at
 of ``static composting''.      least 6 inches of insulating material''
                                with ``that may or may not be covered
                                with insulating material''.
                               --Revision to replace ``humus'' with
                                ``stabilized compost''.
Sec.   112.3(c)--Definition    --Revision corresponding to new
 of ``surface water''.          definition of ``ground water,'' to
                                clarify the differences between the two
                                sources.
Sec.   112.3(c)--Definition    --Revision to replace ``humus'' with
 of ``turned composting''.      ``stabilized compost''.
Sec.   112.3(c)--Definition    --New definition of ``visitor'' added,
 of ``visitor''.                with corresponding deletion of proposed
                                definition that previously appeared in
                                Sec.   112.33(a) (content of final
                                definition is unchanged).
Sec.   112.3(c)--Definition    --Revision to clarify that ``you'' as
 of ``you''.                    used in this part ``means the owner,
                                operator, or agent in charge of a
                                covered farm that is subject to some or
                                all of the requirements of part 112''.
Sec.   112.4.................  --Revision to adjust the monetary
                                threshold for inflation.
                               --Revision to reflect revised definition
                                of ``you''.
Sec.   112.5.................  --Revision to reflect revised definition
                                of ``you''.
Sec.   112.6.................  --Revision to add subpart O (Records) to
                                the list of subparts applicable to farms
                                eligible for the qualified exemption,
                                corresponding to addition of new records
                                provision in Sec.   112.7.
                               --Revision to clarify which other
                                subparts of part 112 are applicable to
                                farms eligible for the qualified
                                exemption.
                               --Revision to reflect revised definition
                                of ``you''.
Sec.   112.7.................  --New provision to establish certain
                                recordkeeping requirements in relation
                                to qualified exemption.
------------------------------------------------------------------------

A. Food That Is Covered and That Is Not Covered (Sec. Sec.  112.1 and 
112.2, and Definition of ``Produce'' in Sec.  112.3(c))

1. Definition of ``Produce'' (Sec.  112.3(c)) and Food That Is Covered 
(Sec.  112.1)
    We are finalizing our definition of ``produce'' with certain 
changes discussed in the paragraphs that follow, and editorial changes 
(adding commas). We note that the definitions of ``produce,'' 
``fruit,'' and ``vegetable'' in this rule are applicable for the 
purposes of this rule. FDA has used different definitions of ``fruit'' 
and ``vegetable'' in certain other contexts and continues to do so. For 
example, see 65 FR 54686 at 54687 (September 8, 2000) (``Although seeds 
are clearly part of the plant kingdom, they are not ordinarily thought 
of as vegetables. Therefore, FDA is concerned that the term `vegetable 
oil sterol esters' may not be understood to cover esterified sterols 
from sources like canola oil''); see also discussion of ``vegetable'' 
in Draft Guidance for Industry: Ingredients Declared as Evaporated Cane 
Juice (``the agency considers the term ``vegetable'' in the context of 
the juice definition to refer more narrowly to edible plant parts that 
consumers are accustomed to eating as vegetables in their diet'') (Ref. 
63).
    (Comment 57) Some comments state that we should not consider 
peanuts or tree nuts to be ``produce'' for the purposes of this 
regulation. In support of this argument, one comment states that there 
are controls in place to limit the level of aflatoxin in nuts.
    (Response) These comments did not provide us with information from 
which to conclude that we should change our view of whether peanuts or 
tree nuts are ``produce'' within the definition in the rule. As 
explained in the 2013 proposed rule, the dictionary definitions of 
``peanut'' and ``nut'' are consistent with our definition of 
``produce,'' the industry appears to recognize peanuts and tree nuts as 
produce, and the biological 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, including the shared hazard of 
pathogens. Aflatoxin, a mycotoxin, is a chemical hazard rather than a 
biological hazard. In section VI of this document, we discuss this 
rule's focus on biological hazards. Because this rule focuses only on 
biological hazards and controls relevant to biological hazards, 
mycotoxin risk is not relevant to

[[Page 74385]]

determining whether peanuts or tree nuts should be considered to be 
``produce'' for the purposes of this rule. Determining that peanuts and 
tree nuts are ``produce'' is only the first step in determining whether 
a particular type of nut, or a particular lot of nuts, is subject to 
the rule. Some types of nuts are not covered by the rule because they 
are rarely consumed raw. Cashews, hazelnuts, peanuts, and pecans are 
listed in Sec.  112.2(a)(1) and are therefore not covered by this rule. 
We also expect that some nuts will be exempt from this rule (with 
appropriate documentation) because they receive commercial processing 
that adequately reduces the presence of microorganisms of public health 
significance under Sec.  112.2(b).
    (Comment 58) Some comments ask whether ``produce'' includes food 
grains, algae, dry legumes, and food crops used in the production of 
spices, dietary ingredients, or food additives. Some comments express 
diverse views and disagree on whether oilseeds (such as sunflower 
seeds) should be considered ``covered produce''.
    (Response) As explained in the 2013 proposed rule, for the purposes 
of part 112, the definition of ``produce'' does not include food 
grains. We explicitly excluded grains from our proposed definition of 
produce, which stated, ``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.'' We are aware that there are 
some commodities, such as sunflower and flax seeds, soybeans, black-
eyed peas, and chickpeas, that are both processed for use in other 
forms (such as oil or flour) and consumed directly as small hard fruits 
or seeds. For example, sunflower seeds can be processed into oil or 
consumed directly as sunflower seeds. When used for direct consumption 
as hard fruits or seeds, these commodities typically receive some 
commercial processing that adequately reduces pathogens, such as 
roasting, before they are consumed and, therefore, these commodities 
are not likely to present the hazards or the level of risk that 
warrants applying the standards of this rule even though they may have 
some uses other than as grains. We are revising the grains definition 
to clarify that such commodities are grains if they are primarily grown 
and processed for use as meal, flour, baked goods, cereals and oils 
rather than for direct consumption. In response to comments, and to 
provide clarity, we are revising the definition of ``produce'' to 
include ``oilseeds'' generally as an example, and to provide flaxseed, 
rapeseed, and sunflower seed as additional examples of grains. We are 
also replacing the term ``fresh consumption'' in this portion of the 
definition with ``direct consumption as small, hard fruits or seeds'' 
for clarity. As revised, this part of the definition states, ``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 
primarily grown and processed for use as meal, flour, baked goods, 
cereals and oils rather than for direct consumption as small, hard 
fruits or seeds (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, and oilseeds (e.g., cotton seed, flax seed, 
rapeseed, soybean, and sunflower seed).''
    As defined, the term ``produce'' includes fruits (the harvestable 
or harvested part of a plant developed from a flower) and vegetables 
(harvested part of any plant or fungus), which by definition does not 
include algae. Algae are organisms that were at one time classified as 
plants due to having chlorophyll and other pigments, but now, with the 
exception of blue-green algae (which are considered to be bacteria, of 
the kingdom Monera), are regarded as belonging in the kingdom Protista 
for possessing cellular features not found among plants and animals and 
for their lack of true stems, roots, and leaves (Ref. 64). Algae do not 
form a distinct phylogenetic group, but include widely varying green, 
brown, and red organisms that grow mostly in water, and can range in 
size from single cells to large spreading masses. Algae are a major 
component of marine plankton and can also be seen as pond scum or as 
blooms in tidal pools (Ref. 65). In addition, algae are not all closely 
related, and do not form a single evolutionary lineage devoid of other 
organisms, which makes classification challenging. As an example, the 
blue-green algae, also known as cyanobacteria, are generally considered 
to be bacteria (Ref. 66), but because blue-greens are aquatic and 
possess photosynthetic pigments like seaweeds, they are still called 
algae (Ref. 67). We do not consider algae to be ``produce'' within the 
scope of this rule. However, algae that are used as ``food'' will 
continue to be covered under the FD&C Act and applicable implementing 
regulations. As appropriate, we may consider issuing guidance on the 
topic of algae production for human food use in the future.
    Legumes are a group of commodities rather than a single commodity. 
For example, peanuts, beans (such as lima beans, white pea beans, and 
great Northern beans) and lentils (such as green lentils, yellow 
lentils, and brown lentils) are all legumes. Many legumes fall within 
our definition of ``produce'' but also meet the criteria for produce 
that is rarely consumed raw, and are therefore not subject to this rule 
under Sec.  112.2(a)(1).
    For example, as discussed in the 2013 proposed rule, we consider 
that peanuts fit within the definition of produce (78 FR 3504 at 3536). 
However, peanuts are rarely consumed raw and are therefore not subject 
to this rule under Sec.  112.2(a)(1).
    As another example, we consider beans to fit within the definition 
of produce. Beans are typically sold in both a ``fresh'' and a dried 
form and the drying in these cases creates a distinct commodity. The 
fresh beans are produce RACs (rather than processed foods) and are 
subject to this rule except where an exemption applies. Some types of 
fresh beans are not subject to this rule because they fit the criteria 
for produce that is rarely consumed raw, and are therefore exempt under 
Sec.  112.2(a)(1) (e.g., black beans, great Northern beans, and kidney 
beans are exempt). Other types of fresh beans (for example, broad 
beans, cowpea beans, and pink beans) do not meet the criteria for 
rarely consumed raw and therefore are covered produce except where 
another exemption applies. We understand that many beans receive 
commercial processing that adequately reduces the presence of 
microorganisms of public health significance, such that in many cases, 
beans that are not exempt from this rule as rarely consumed raw may be 
eligible for the exemption in Sec.  112.2(b). In addition, dried beans 
are distinct commodities from fresh beans and are therefore processed 
foods. Processed foods are not subject to this rule (see Sec.  
112.2(a)(3)), such that once beans subject to this rule are dried/
dehydrated, they are no longer subject to this rule.
    We also consider that lentils fit within the definition of produce. 
Lentils are the edible part of an herbaceous plant grown for an edible 
part, and are the harvestable or harvested part of the

[[Page 74386]]

plant. Lentils are ``small, hard fruits or seeds of arable crops'' (the 
first part of the definition of grains), but because they are not 
primarily grown and processed for use as ``meal, flour, baked goods, 
cereals and oils'' rather than for direct consumption (Ref. 68), they 
are not ``grains'' as we have defined that term, and therefore they are 
produce. However, lentils are rarely consumed raw and are therefore not 
subject to this rule under Sec.  112.2(a)(1).
    The definition of ``produce'' in Sec.  112.3 and the provisions for 
produce that is not covered under this rule in Sec.  112.2(a) apply 
regardless of whether that produce is used in other finished foods. 
Produce that is covered under this rule is eligible for exemption if it 
receives commercial processing that adequately reduces the presence of 
microorganisms of public health significance (Sec.  112.2(b)). Produce 
that is used in the production of spices, ingredients of dietary 
supplements, or food additives, to the extent it is covered produce 
(i.e., it is not excluded under Sec.  112.2(a)), may be eligible for 
exemption under Sec.  112.2(b) if it meets the criteria set forth in 
that section. Such produce is not exempt by virtue of its use in 
spices, dietary supplements, or food additives; such produce may be 
exempt only if it meets the criteria in Sec.  112.2(b) (i.e., it 
receives commercial processing that adequately reduces the presence of 
microorganisms of public health significance and the covered farm takes 
the required steps set forth in that section). As discussed previously, 
processed foods are not subject to this rule (see Sec.  112.2(a)(3)), 
such that once produce RACs subject to this rule are made into 
processed foods, those processed foods are not subject to this rule.
    (Comment 59) Some comments ask whether edible flowers that are 
consumed raw are considered ``covered produce.''
    (Response) Within the definition of produce, we define a 
``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). Edible flowers fit within our 
definition of ``produce'' and when reasonably expected to be directed 
to a food use, unless otherwise exempt under other provisions of 
subpart A, they are covered produce subject to the requirements of this 
rule.
    (Comment 60) One comment questions whether FDA intends to apply the 
rule to farms that export their produce to foreign countries.
    (Response) Section 112.1(a) explains that the rule coves produce 
RACs that are 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. This 
includes produce RACs that are grown domestically for export to foreign 
countries.
2. Produce That Is Covered and Not Covered (Sec.  112.2)
    (Comment 61) One comment states that the proposed produce safety 
rule should apply to all fruit and vegetable commodities, and opposes 
all of the exemptions we proposed in Sec.  112.2. This comment argues 
that people are consuming more fruits and vegetables to maintain a 
healthier diet, and thus all fruit and vegetables should be subject to 
the same preventive safety requirements.
    (Response) We disagree. FSMA mandates that FDA set risk-based 
standards to ensure the safety of produce. In Sec. Sec.  112.2(a)(1) 
and 112.2(b), we exempt, or make eligible for exemption, produce that 
pose little to no risk of foodborne illness, either because it is 
rarely consumed raw (Sec.  112.2(a)(1)) (see section IX.A.3 of this 
document) or because it receives commercial processing that adequately 
reduces the presence of pathogens (Sec.  112.2(b)). We conclude that it 
is not reasonably necessary to apply the requirements of the rule to 
such produce to minimize the risk of serious adverse health 
consequences or death or to provide reasonable assurances that produce 
is not adulterated under section 402 of the FD&C Act. In addition, we 
exempt produce that is produced by an individual for personal 
consumption or produced for consumption on the farm or another farm 
under the same management (Sec.  112.2(a)(2)), and produce that is not 
a raw agricultural commodity (Sec.  112.2(a)(3)). These exemptions are 
consistent with sections 419(g) and 419(a)(1)(A), respectively, of the 
FD&C Act. We note, however, that produce exempt from this rule under 
Sec.  112.2 is and will continue to be covered under the adulteration 
provisions and other applicable provisions of the FD&C Act and 
applicable implementing regulations, irrespective of whether it is 
included within the scope of the produce safety regulation.
3. Produce That Is Exempt Because It Is Rarely Consumed Raw (Sec.  
112.2(a)(1))
    (Comment 62) Some comments oppose exempting produce commodities 
based on the produce being rarely consumed raw. One such comment argues 
that the public has an expectation that FDA will oversee and regulate 
all fruits and vegetables. This comment suggests that an appropriate 
approach would be to provide regulatory oversight combined with 
guidance documents addressing specific variability applicable to 
different fruits and vegetables, which in the view of this comment, 
would be similar to the seafood HACCP regulation. Other comments point 
out that rarely consumed raw produce may still cause food safety 
problems. One commenter explains that food safety begins with 
agricultural growing practices and continues through the supply chain 
to the consumer, and believes that exemption of produce rarely consumed 
raw would ignore the issue of potential cross-contamination at retail 
and during food preparation by consumers. Another commenter suggests 
that any produce exempt as rarely consumed raw should be required to 
undergo a processing step that adequately reduces the presence of 
microorganisms of public health concern.
    (Response) As discussed in section IV.A.2.a of the 2013 proposed 
rule, we are exempting produce that is ``rarely consumed raw'' from the 
requirements of part 112 because such fruits and vegetables are almost 
always consumed only after being cooked, which is a kill-step that can 
be expected to adequately reduce the presence of microorganisms of 
public health significance in most cases. Studies have shown that the 
numbers of microorganisms of public health significance (such as L. 
monocytogenes, Salmonella, STEC) are significantly reduced in produce 
by a variety of relatively moderate heat treatments (Ref. 69) (Ref. 70) 
(Ref. 71) (Ref. 72). Therefore, cooking that produce receives before it 
is consumed, whether commercially or by the consumer, can be expected 
to reduce the risk of serious adverse health consequences or death 
associated with commodities that are rarely consumed raw. As a result, 
FDA concludes it is not reasonably necessary to subject such 
commodities to requirements under this rule, or in the alternative to 
require such commodities to undergo a processing step to adequately 
reduce pathogens.
    We are not aware of any information or scientific data suggesting 
that cross-contamination at retail or during food preparation in the 
home represent a

[[Page 74387]]

significant concern for any of the commodities that we are identifying 
as ``rarely consumed raw'' produce. The 2013 FDA Model Food Code 
includes provisions (e.g., 3-302.11) designed to protect food against 
cross-contamination in retail settings.
    We also note that rarely consumed raw produce commodities that are 
exempt from this rule under Sec.  112.2(a)(1) are and will continue to 
be covered under the adulteration provisions and other applicable 
provisions of the FD&C Act and applicable implementing regulations, 
irrespective of whether they are included within the scope of this 
rule.
    (Comment 63) One commenter suggests revising the rarely consumed 
raw exemption so that it would be invalidated for a specific farm if 
that farm's otherwise rarely consumed raw produce were marketed for 
fresh consumption.
    (Response) We are not adopting this approach. The Sec.  112.2(a)(1) 
exemption from the requirements of part 112 is based on our finding 
that commodities that are almost always consumed only after being 
cooked constitute very low to no risk with respect to biological 
hazards (see Ref. 29) and, therefore, it is not reasonably necessary to 
apply the standards established in part 112 to these commodities. This 
determination applies without regard to the manner in which such 
commodities may be marketed. Such commodities are and will continue to 
be covered under the adulteration provisions and other applicable 
provisions of the FD&C Act and applicable implementing regulations, 
irrespective of whether they are included within the scope of this 
rule. Manufacturers and producers of food, including produce, for human 
consumption have the responsibility to ensure the safety of their food.
    (Comment 64) Some comments, while not opposed to exempting certain 
produce commodities rarely consumed raw, disagree with FDA establishing 
an exhaustive list of such exempted produce. Multiple comments express 
a preference for guidance documents to indicate to industry which foods 
FDA considers to be rarely consumed raw and therefore exempt from the 
rule. These commenters argue that such an approach would be preferable 
because it would allow the exemption to reflect new data and changes in 
dietary habits without requiring FDA to conduct rulemaking to update an 
exhaustive list.
    (Response) We considered and rejected the possibility of providing 
a list of rarely consumed raw commodities in guidance without 
establishing any specific criteria for what ``rarely consumed raw'' 
means in the regulation, because such an approach would present 
significant challenges for compliance and enforcement. For example, 
such an approach would require covered farms to implement the standards 
in part 112 without FDA clearly identifying in the rule itself whether 
and which of the farm's commodities would be subject to those 
standards. We also considered providing a list of rarely consumed raw 
commodities in guidance with accompanying underlying quantitative 
criteria listed in the regulation. We rejected this approach because 
it, too, would not be adequate for the purposes of clarity of coverage 
and could present challenges for compliance and enforcement. The 
complexity of the analysis (see Ref. 73) necessary to obtain 
consumption patterns that consistently and adequately represent 
consumption among consumers across the United States does not make this 
a viable approach. Therefore, we are adopting the proposed approach, in 
which we explicitly provide an exhaustive list of rarely consumed raw 
commodities within Sec.  112.2(a)(1). However, we are revising our 
proposed list based on an analysis of more recent data and taking into 
account comments received. Moreover, we intend to consider updating the 
list of rarely consumed raw commodities in the future as appropriate, 
such as if new data become available.
    Section 112.2(a)(1) provides an exhaustive list of produce that is 
rarely consumed raw and is, therefore, exempt from coverage under this 
rule. We conclude these commodities are predominantly eaten cooked by 
most consumers across the United States at this time. The 
identification of a commodity on this list does not mean that the 
produce is never eaten raw or that it is not eaten raw, typically or 
occasionally, in specific regions of the United States (or among 
specific ethnic communities in the United States). This list also does 
not reflect the form in which these commodities are consumed by 
populations in other countries, where the produce may be grown and/or 
from which the produce may be imported into the United States. 
Furthermore, our analysis underlying the development of this list 
reflects dietary intake information that consumers across the United 
States reported in a national survey. The most recent of these data 
that are currently available show consumption that was reported only as 
recently as 2010, but not consumption as it occurs today. Therefore, 
this list may not necessarily reflect or fully reflect current or 
emerging patterns of forms in which produce is consumed or new dietary 
trends toward consumption of raw foods.
    As revised, Sec.  112.2(a)(1) lists the following produce as rarely 
consumed raw among United States consumers: Asparagus; beans, black; 
beans, great Northern; beans, kidney; beans, lima; beans, navy; beans, 
pinto; beets, garden (roots and tops); beets, sugar; cashews; cherries, 
sour; chickpeas; cocoa beans; coffee beans; collards; corn, sweet; 
cranberries; dates; dill (seeds and weed); eggplants; figs; ginger; 
hazelnuts; horseradish; lentils; okra; peanuts; pecans; peppermint; 
potatoes; pumpkins; squash, winter; sweet potatoes; and water 
chestnuts.
    For this final rule, we conducted an updated analysis of dietary 
consumption of produce in the United States to identify those produce 
RACs that we consider to be rarely consumed raw. We evaluated food 
consumption data available in the National Health and Nutrition 
Examination Survey/What We Eat in America (NHANES/WWEIA) database, 
specifically the datasets available from the 2003-2010 NHANES/WWEIA 
surveys (Ref. 74). By comparison, in the 2013 proposed rule, we were 
using the datasets available from the 1999-2006 NHANES/WWEIA surveys 
(Ref. 75). In addition, in both this final rule and the 2013 proposed 
rule, we used the Food Commodity Intake Database (FCID) (Ref. 76), 
developed by the EPA's Office of Pesticide Programs, to identify 
proportions of produce (as that terms is defined for purposes of this 
rule) present as ingredients in foods/food categories listed in the 
NHANES/WWEIA datasets. Moreover, where NHANES/WWEIA datasets provide 
the necessary data, we made additional modifications to our analysis 
compared to the analysis described in the 2013 proposed rule to provide 
a more robust evaluation of consumption in the United States. For 
example, in our updated analysis, we evaluated all produce commodities 
included in FCID as applied to the NHANES/WWEIA surveys rather than 
just a subset of the FCID commodities. In our updated analysis, we 
characterized each eating occasion based on meals and snacks reported 
by survey respondents (e.g., breakfast, brunch, lunch, dinner, supper, 
snacks) such that each snack is considered a separate eating occasion. 
In our updated analysis, we also considered consumption based on both 
one-day dietary intakes and 2-day dietary intakes reported by survey

[[Page 74388]]

respondents in the NHANES/WWEIA datasets.
    In addition, we added a third element to the set of criteria we 
applied to determine whether a commodity is rarely consumed raw. In the 
2013 proposed rule, we applied two criteria, i.e., the commodity is 
consumed uncooked by less than 0.1 percent of population and it is 
consumed uncooked on less than 0.1 percent of eating occasions. As 
mentioned above, we considered these two criteria together, and for the 
final analysis we considered that these two criteria were satisfied for 
a commodity if either the 1-day dietary intake data, the 2-day dietary 
intake data, or both met both criteria. For the final analysis, we also 
added a third criterion, i.e., we identified those commodities for 
which consumption (in any form--raw, processed, or other) was reported 
by at least 1 percent of weighted number of survey respondents. We 
added this threshold in response to comments and anecdotal evidence 
suggesting that our proposed criteria were not sufficiently robust 
because they resulted in exemptions for several commodities that seem 
likely to be consumed raw with significant frequency. For example, 
kale, which we proposed to exempt, was identified by many commenters as 
being regularly consumed raw. This is reflected in the inclusion of raw 
kale in popular restaurant dishes (Ref. 77) (Ref. 78) (Ref. 79); 
recipes from nationally-recognized chefs (Ref. 80) (Ref. 81); and 
reports in public media (Ref. 82) (Ref. 83) (Ref. 84) (Ref. 85) (Ref. 
86) (Ref. 87). To improve the robustness of our analysis and to ensure 
that our conclusions that commodities are rarely consumed raw are 
sufficiently reliable to justify removing those commodities from the 
rule's coverage, we concluded that we should add another criterion to 
the analysis. We concluded that where fewer than 1 percent of the 
weighted number of survey respondents reported consuming the commodity 
in any form, we did not have sufficient data to provide a reasonable 
representation of how the commodity is consumed in the U.S. for the 
purposes of exempting commodities from the coverage of this rule. Thus, 
in addition to meeting the criteria we originally proposed, at least 1 
percent of the weighted number of survey respondents over the eight 
year timespan of the NHANES/WWEIA surveys must have reported consuming 
the commodity (all forms, taken together, excluding juice/juice drinks) 
for us to conclude that the commodity is rarely consumed raw and should 
therefore be exempt from this rule. Accordingly, for all commodities 
meeting the first two criteria, we also analyzed whether the 
commodity's 2-day consumption number ``N'' was equal to or greater than 
2,938,915 (293,891,529 x 0.01), whether its 1-day consumption number 
``N'' was equal to or greater than 2,938,517 (293,851,741 x 0.01), or 
both. Our analysis is described in greater detail in an accompanying 
memo to the record (Ref. 73).
    Based on our analysis of the NHANES/WWEIA datasets, we identified a 
list of produce commodities that we consider to be rarely consumed raw, 
applying the revised criteria. First, there are the commodities for 
which quantitative data about uncooked consumption is available and 
that meet three numerical thresholds either in the one-day reported 
intakes, 2-day reported intakes, or both, based on FCID analyses of 
NHANES/WWEIA datasets, i.e., at least 1 percent of weighted number of 
survey respondents having reported consuming the commodity in any form; 
commodities consumed uncooked by less than 0.1 percent of the United 
States population; and commodities consumed uncooked on less than 0.1 
percent of eating occasions. See column 1 of Table 5.
    Second, there are commodities included in the NHANES/WWEIA datasets 
for which categories of reported consumption in the NHANES/WWEIA 
surveys do not include an ``uncooked'' food form. We conclude that such 
commodities may also be reasonably considered to fall beneath the 
numerical thresholds of being consumed uncooked by less than 0.1 
percent of the United States population and consumed uncooked on less 
than 0.1 percent of eating occasions because lack of an ``uncooked'' 
reported food form indicates that they were not consumed uncooked in 
any measurable quantity. To such commodities, we applied the new 
numerical threshold, i.e., at least 1 percent of weighted number of 
survey respondents must have reported consuming the commodity in any 
form for the data to provide a reasonable representation of how that 
commodity is consumed by U.S. consumers. See column 2 of Table 5.
    Third, the consumption of certain produce RACs is reported in the 
NHANES/WWEIA not as RACs, but only in the form of certain processed 
foods. For example, coffee beans are only reported consumed in beverage 
form as coffee; and cocoa beans are only reported consumed as cocoa 
beverage, chocolate beverage, chocolate, or related products. We 
conclude that these commodities are rarely consumed raw when the only 
forms in which they are reported in the NHANES/WWEIA surveys indicates 
they were cooked as part of the process of being made into the 
identified processed foods, and therefore we infer that they fall 
beneath the numerical thresholds of being consumed uncooked by less 
than 0.1 percent of the United States population and consumed uncooked 
on less than 0.1 percent of eating occasions because they were not 
consumed uncooked in any measurable quantity. To such commodities, we 
applied the new numerical threshold, i.e., at least 1 percent of 
weighted number of survey respondents must have reported consuming the 
commodity in any form for the data to provide a reasonable 
representation of how that commodity is consumed by U.S. consumers. We 
are therefore adding them to the list of rarely consumed raw produce in 
Sec.  112.2(a)(1). See column 3 of Table 5.

   Table 5--List of Produce That Are Rarely Consumed Raw in the United
                                 States
 [Based on an analysis of the National Health and Nutrition Examination
 Survey/What We Eat in America Survey Datasets Using the Food Commodity
                            Intake Database]
------------------------------------------------------------------------
                                     ``No uncooked    ``Processed food''
                                     code'' NHANES     NHANES analysis:
                                  analysis: At least    At least 1% of
    ``Complete data'' NHANES        1% of weighted    weighted number of
    analysis: At least 1% of           number of          respondents
 weighted number of respondents       respondents          consuming
consuming commodity in any form;       consuming       commodity in any
  less than 0.1% of population     commodity in any   form; and reported
 consumed uncooked; AND on less      form; and no      consumed only in
 than 0.1% of eating occasions,      uncooked code      processed food
   using either 1-day or 2-day        reported in       form with cook
             survey                  NHANES, using     step using either
                                  either 1-day or 2-    1-day or 2-day
                                      day survey            survey
------------------------------------------------------------------------
Asparagus.......................  Beans, black......  Coffee beans.
Beans, lima.....................  Beans, great        Cocoa beans.
                                   Northern.
Beets, garden (roots and tops)..  Beans, kidney.....  ..................
Beets, sugar....................  Beans, navy.......  ..................

[[Page 74389]]

 
Cherries, sour..................  Beans, pinto......  ..................
Chickpeas.......................  Cashews...........  ..................
Collards........................  Hazelnuts.........  ..................
Corn, sweet.....................  Lentils...........  ..................
Cranberries.....................  Okra..............  ..................
Dates...........................  Peanuts...........  ..................
Dill (seeds and weed)...........  Peppermint........  ..................
Eggplants.......................  Squash, winter....  ..................
Figs............................  Sweet potatoes....  ..................
Ginger.                                               ..................
Horseradish.                                          ..................
Pecans.                                               ..................
Potatoes.                                             ..................
Pumpkins.                                             ..................
Water chestnuts.                                      ..................
------------------------------------------------------------------------

    Table 6 shows a comparison of proposed to final rarely consumed raw 
commodities.

  Table 6--Comparison of Proposed to Final List of Rarely Consumed Raw
              Commodities Identified in Sec.   112.2(a)(1)
           [All analyses combined, alphabetical by commodity]
------------------------------------------------------------------------
                Proposed                              Final
------------------------------------------------------------------------
Arrowhead \1\; Arrowroot \1\;            Asparagus; Beans, black \2\;
 Artichokes \1\; Asparagus; Beets;        Beans, great Northern \2\;
 Black-eyed peas \1\; Brussels sprouts    Beans, kidney; Beans, lima;
 \1\; Bok choy \1\; Chick-peas;           Beans, navy \2\; Beans, pinto;
 Collards; Crabapples \1\; Cranberries;   Beets, garden (roots and
 Eggplant; Figs; Ginger root; Kale \1\;   tops); Beets, sugar; Cashews
 Kidney beans; Lentils; Lima beans;       \2\; Cherries, sour \2\;
 Okra; Parsnips \1\; Peanuts; Pinto       Chickpeas; Cocoa beans \2\;
 beans; Plantains \1\; Potatoes;          Coffee beans \2\; Collards;
 Pumpkin; Rhubarb \1\; Rutabaga \1\;      Corn, sweet; Cranberries;
 Sugarbeet; Sweet corn; Sweet potatoes;   Dates \2\; Dill (seeds and
 Taro \1\; Turnips \1\; Water chestnut;   weed) \2\; Eggplants; Figs;
 Winter squash; Yams \1\.                 Ginger; Hazelnuts \2\;
                                          Horseradish \2\; Lentils;
                                          Okra; Peanuts; Pecans \2\;
                                          Peppermint \2\; Potatoes;
                                          Pumpkins; Squash, winter;
                                          Sweet potatoes; Water
                                          chestnuts.
------------------------------------------------------------------------
\1\ Removed from list in final rule.
\2\ Added to list in final rule.

    Table 7 shows changes in the nomenclature for rarely consumed raw 
commodities in proposed Sec.  112.2(a)(1) to final Sec.  112.2(a)(1).

 Table 7--Changes in Commodity Nomenclature From Proposed to Final List
                 of ``Rarely Consumed Raw'' Commodities
------------------------------------------------------------------------
  Commodity name in proposed
             list                     Commodity name in final list
------------------------------------------------------------------------
Beets........................  Beets, garden (roots and tops).
Chick-peas...................  Chickpeas.
Ginger root..................  Ginger.
Kidney beans.................  Beans, kidney.
Lima beans...................  Beans, lima.
Pinto beans..................  Beans, pinto.
Sugarbeet....................  Beets, sugar.
Sweet corn...................  Corn, sweet.
Winter squash................  Squash, winter.
------------------------------------------------------------------------

    We acknowledge there are certain limitations to this analysis. 
Although the NHANES/WWEIA datasets are the most comprehensive and 
robust, nationally-representative datasets currently available on 
dietary intakes in the United States, we recognize that they do not 
cover all commodities and that the data are incomplete or limited in 
certain cases, as discussed previously. In addition, we agree with 
several commenters who point out that

[[Page 74390]]

dietary consumption patterns can change over time such that produce not 
currently consumed raw may be consumed raw (and reported as 
``uncooked'' based on FCID analyses of NHANES/WWEIA datasets) in the 
future, or vice versa. Nevertheless, we can only analyze consumption 
patterns using data that necessarily lags behind changes in 
consumption. While the data source we have has certain limitations, it 
is the best we could identify for this purpose. Moreover, we believe it 
is consistent with providing standards that minimize the risk of 
serious adverse health consequences or death to exempt from such 
standards as ``rarely consumed raw'' only those commodities for which 
we have robust, quantitative data from nationally representative data 
sources (such as NHANES/WWEIA and FCID) supporting a conclusion that 
the commodity is rarely consumed raw. We recognize that our current 
list of produce that is rarely consumed raw may need to be updated as 
new information becomes available.
    As discussed previously, we also understand that the overall 
consumption rates of some produce in the United States are too low for 
the NHANES/WWEIA data to be useful to evaluate whether the produce is 
rarely consumed raw or even whether it is consumed in any form. In this 
final rule we are establishing a factor of weighted number of 
respondents of at least 1 percent of the total respondents to the eight 
year span of 2003-2010 NHANES/WWEIA surveys to apply as a threshold 
that provides a reasonable representation of the frequency with which a 
commodity is consumed by U.S. consumers. For foods that are reported 
consumed (in any form) by fewer than a weighted number of 2,938,915 
respondents (for 2-day intakes) or 2,938,517 (for 1-day intakes), we 
consider the overall reported rate to be too low to justify relying on 
these data as a reasonable representation of consumption among U.S. 
consumers for purposes of this rule. Therefore, we consider that such 
commodities should be covered by the rule. For example, certain 
tropical fruits (such as guava, kumquat, and lychee) meet two of the 
three criteria (i.e., consumed uncooked by less than 0.1 percent of the 
United States population and consumed uncooked on less than 0.1 percent 
of eating occasions) based on the NHANES/WWEIA datasets. However, these 
commodities are reported consumed by fewer than 1 percent weighted 
number of respondents, and we conclude that this is insufficient to 
provide a reasonable representation of consumption across U.S. 
consumers for purposes of excluding such commodities from the coverage 
of this rule as rarely consumed raw. As another example, certain 
regional or ethnic foods that are not widely consumed by the United 
States population are not covered in the NHANES/WWEIA datasets and, 
therefore, we have no robust, nationally-representative data from which 
to determine whether or not such foods are typically consumed cooked 
among United States consumers. As a result, we are not exempting such 
commodities, but we intend to consider updating the list of rarely 
consumed raw commodities in the future as appropriate, such as if new 
data become available. We encourage stakeholders who have information 
about produce commodities not currently reported in NHANES/WWEIA 
datasets or included in FCID recipes, or reported consumed in any form 
by fewer than 1 percent weighted number of respondents in the NHANES/
WWEIA surveys to identify relevant data for FDA's review and 
evaluation. To be useful, such data would need to be sufficiently 
robust and representative of consumption of relevant commodities across 
the United States to allow us to draw scientifically-valid conclusions.
    (Comment 65) Some comments seek clarification regarding the meaning 
of ``raw'' and ``uncooked'' as those terms apply to proposed Sec.  
112.2(a)(1). One comment states that their interpretation of ``raw'' 
extends beyond cooking at the consumer level, and that although both 
consumer-level cooking and commercial processing can reduce pathogen 
populations, these are treated differently in the proposed regulation. 
The comment urges FDA to recognize the broad range of commercial 
practices that could similarly justify designating a food as rarely 
consumed raw. Other comments suggest that commodities treated with 
propylene oxide (PPO) to reduce levels of Salmonella and other 
vegetative pathogens should be exempt as rarely consumed raw. These 
comments state that, although such PPO-treated products are likely to 
be seen as ``raw'' by consumers, they undergo an appropriate pathogen 
reduction control step.
    (Response) We are exempting produce that is ``rarely consumed raw'' 
from the requirements of part 112 in Sec.  112.2(a)(1) because such 
fruits and vegetables are almost always consumed only after being 
cooked, which is a kill-step that can be expected to adequately reduce 
the presence of microorganisms of public health significance in most 
cases. Our use of ``produce that is rarely consumed raw'', therefore, 
is intended to mean that such produce commodities are almost always 
eaten only after being cooked (i.e., heat treated in some form). We do 
not distinguish between cooking conducted by a consumer or a food 
manufacturer.
    The exemption provided for rarely consumed raw produce (in Sec.  
112.2(a)(1)) is separate and distinct from the eligibility for 
exemption provided for produce that receives commercial processing (in 
Sec.  112.2(b)). Produce commodities exempt under Sec.  112.2(a)(1) are 
almost always eaten only after being cooked and, therefore, the 
exemption applies generally for that commodity regardless of the method 
of preparation prior to consumption. For example, we consider that 
potatoes meet the criteria for rarely consumed raw and, although they 
may be consumed in different forms, they are almost always cooked prior 
to consumption. We also recognize that foods that are rarely consumed 
raw may be cooked in a home setting by the consumer or in a commercial 
setting by a food manufacturer/processor. In contrast, produce may be 
exempt, if eligible, under Sec.  112.2(b), even if the commodity 
involved is not always consumed only after cooking. For example, 
tomatoes are frequently consumed raw, without any cooking, but also can 
be consumed after they receive commercial processing that adequately 
reduces pathogens, such as treating with a validated process (e.g., as 
processing to produce tomato paste or shelf-stable tomatoes) to 
eliminate spoilage organisms and destroy vegetative pathogens (such as 
Salmonella, L. monocytogenes, and E. coli O157:H7). Tomatoes are 
eligible for exemption under Sec.  112.2(b) only in the latter case 
(where the farm is required to take certain actions (see section IX.A.4 
of this document), including establishing and keeping certain 
documentation), but not in the former case where the tomatoes do not 
receive such a commercial processing step. Therefore, it would not be 
appropriate to combine the exemptions in Sec.  112.2(a)(1) and (b) into 
a single general exemption. We note that produce that receives a PPO 
treatment may be eligible for the exemption in Sec.  112.2(b) if all 
relevant conditions are met, including that the treatment adequately 
reduces the presence of microorganisms of public health significance.
    We recognize, however, that a produce commodity that is generally 
exempt from this part because it is rarely consumed raw may, in some 
cases, also receive commercial processing that adequately reduces the 
presence of microorganisms of public health significance. However, 
because

[[Page 74391]]

such commodity is already exempt under Sec.  112.2(a)(1), we would not 
consider the commodity under the provision in Sec.  112.2(b)(1) or 
expect the farm to take the steps required under Sec.  112.2(b)(2).
4. Produce That Is Eligible for Exemption Based on Receipt of 
Commercial Processing That Adequately Reduces Pathogens (Sec.  
112.2(b))
    (Comment 66) Some comments that are generally supportive of the 
exemption for produce that undergoes commercial processing that 
adequately reduces pathogens state that it is essential to ensure that 
such produce does not then re-enter the fresh produce supply chain if 
it does not eventually receive the required processing. One comment 
expresses concern about the exemption and states that diversion of 
``processing grown'' cannery, Roma, or plum tomatoes is a common 
practice. This comment states that there are numerous instances where 
tomatoes grown for commercial processing that would adequately reduce 
pathogens were shipped to Mexico, relabeled for sale as RACs in the 
fresh produce market, and then shipped back into the United States as 
RACs. One comment states the documentation requirements described under 
proposed Sec.  112.2(b) would not be practicable for some farms. 
According to this comment, for example, wine grapes delivered to a 
winery are generally made into wine, but the farm will usually not be 
privy to the specific production processes that the crop undergoes nor 
who performs them. The comment further notes that wine grapes delivered 
to a winery may be crushed and converted to grape must at the first 
facility, and then transferred to another winery for fermentation and 
additional processing, without any knowledge by the farm.
    (Response) The exemption in Sec.  112.2(b) applies to produce that 
receives commercial processing that adequately reduces the presence of 
pathogens. Thus, the exemption is only available to produce that is 
actually processed in a manner that adequately reduces pathogens. The 
failure to comply with the requirements of part 112 is a prohibited act 
under section 301(vv) of the FD&C Act, as set forth in Sec.  112.192, 
for which FDA may take appropriate action. Therefore, it is important 
that covered farms that rely on the exemption in Sec.  112.2(b) ensure 
that the relevant produce meets the exemption criteria and take the 
steps required in revised Sec.  112.2(b).
    We are adding certain examples to this paragraph to make clear that 
such commercial processing includes processing produce into products in 
which the nature of the product or its production process as a whole, 
rather than a single ``kill step,'' adequately reduces the presence of 
pathogens. We are adding as examples of commercial processing that 
adequately reduces the presence of microorganisms of public health 
concern ``otherwise manufacturing/processing produce into products such 
as . . . wine, beer, or similar products.'' Winemaking and brewing beer 
adequately reduce the presence of microorganisms of public health 
significance (Ref. 88).
    Fresh-cut processing does not qualify as commercial processing that 
adequately reduces the presence of pathogens for the purposes of the 
exemption in Sec.  112.2(b). As described in FDA's Guide to Minimize 
Microbial Food Safety Hazards of Fresh-cut Fruits and Vegetables (Ref. 
89), processing produce into fresh-cut products can increase the risk 
of bacterial growth and contamination. Adding antimicrobial substances 
to produce wash water at a fresh-cut manufacturing/processing facility 
can reduce the likelihood of produce contamination, including for 
example to help prevent the cross-contamination of surrounding produce 
with any pathogens that may be introduced into the wash water from a 
single fruit or vegetable. However, washing does not adequately reduce 
the presence of pathogens (see also our response to Comment 334). FDA's 
Guide to Minimize Microbial Food Safety Hazards of Fresh-cut Fruits and 
Vegetables (Ref. 89) clearly identifies the need for use of both good 
agricultural practices and good manufacturing practices to prevent or 
minimize microbial hazards in fresh-cut produce.
    In light of the comments about farms' limited knowledge of the 
specific production processes that their crop undergoes at later stages 
of the supply chain and the entities performing such processes; and in 
light of our approach to similar issues in the PCHF regulation, we have 
revised the conditions of this exemption. The revised requirements are 
more practicable for farms with respect to their limited knowledge of 
the entities and processes involved in the distribution chain 
subsequent to the farm's own customer. The revised requirements are 
also consistent with similar requirements in Sec. Sec.  117.136 and 
117.137 of the PCHF regulation, and in Sec.  1.507 of the FSVP 
regulation, which allow facilities and importers, respectively, to rely 
on customers and subsequent entities in the distribution chain to 
control hazards under certain circumstances.
    Under the first of the new provisions (Sec.  112.2(b)(2)), you must 
disclose in documents accompanying the produce that the food is not 
processed to adequately reduce the presence of microorganisms of public 
health significance. The documents that accompany the produce could be 
bills of lading or other papers that accompany the produce, or the 
containers may be labeled with this information. Under the next of the 
new provisions, (Sec.  112.2(b)(3)), you must annually obtain certain 
written assurances from your customer with respect to the produce for 
which you rely on this exemption. This may be an assurance from the 
customer that the customer has established and is following procedures 
that adequately reduce the presence of microorganisms of public health 
significance (Sec.  112.2(b)(3)(i)), or it may be an assurance from the 
customer that an entity after the customer in the distribution chain 
will perform such processing (Sec.  112.2(b)(3)(ii)). In the latter 
case, the customer's written assurance must also affirm that the 
customer will disclose in documents accompanying the food that the food 
is not processed to adequately reduce the presence of microorganisms of 
public health significance and that the customer will only sell to 
another entity that agrees, in writing, that it will either: (1) Follow 
procedures (identified in a written assurance) that adequately reduce 
the presence of microorganisms of public health significance or (2) 
obtain a similar written assurance from its customer that the produce 
will receive the required commercial processing and that there will be 
disclosure in documents accompanying the food that it is not processed 
to adequately reduce microorganisms of public health significance. 
Under Sec.  112.2(b)(4), we are requiring you to keep documentation of 
the disclosures required under Sec.  112.2(b)(2), and the annual 
written assurances obtained from customers required under Sec.  
112.2(b)(3). This replaces the requirement in the 2013 proposed rule 
that you keep documentation of the identity of the recipient of the 
produce that performs the commercial processing, as we recognize that a 
farm may not have knowledge of the identity of the entity performing 
such processing. We are finalizing the requirement in Sec.  112.2(b)(5) 
(proposed as Sec.  112.2(b)(3)) that the requirements of this subpart 
and subpart Q apply to produce exempt under this section, without 
change.
    In addition, while we are not requiring specific language for the

[[Page 74392]]

written assurances described in Sec.  112.2(b)(3), we are specifying in 
Sec.  112.2(b)(6) that the entities that provide them must act 
consistently with the assurances and document the actions taken to 
satisfy the assurance. Section 112.2(b)(6) applies not just to covered 
farms, but to other entities that voluntarily agree to provide the 
written assurances described in Sec.  112.2(b)(3). The application of 
this requirement to facilities subject to the section 418 of the FD&C 
Act is consistent with section 419(h) of the FD&C Act. Providing, 
complying with, and documenting compliance with the written assurances 
described in Sec.  112.2(b)(3) are not activities that are subject to 
section 418 of the FD&C Act. We believe the combination of the written 
assurance, the disclosure in accompanying documents that the food is 
not processed to adequately reduce microorganisms of public health 
significance, and the requirements to act consistently with the written 
assurance will provide a reasonable level of protection to ensure that 
produce that is exempt from the requirements of part Sec.  112 under 
this section actually receives the required commercial processing and 
will not be diverted to the fresh produce market.
    (Comment 67) One comment recommends that frozen vegetables should 
be eligible for exemption under Sec.  112.2(b) because, according to 
this commenter, most commercially frozen vegetables are blanched before 
freezing and are subsequently not intended to be eaten raw. This 
commenter also states that blanching involves temperatures from 
140[emsp14][deg]F to 180[emsp14][deg]F for one or more minutes, and 
effectively eliminates harmful bacteria. In addition, the commenter 
believes that a frozen or previously frozen, thawed vegetable is 
typically not desirable for raw consumption and is rarely consumed raw.
    (Response) Produce, including vegetables, that receive commercial 
processing that adequately reduces the presence of pathogens is 
eligible for exemption under Sec.  112.2(b) if all of the conditions in 
that section are met. Blanching and/or freezing processes may qualify 
if they are validated to ensure that the specific procedures followed 
adequately reduce pathogens in the food. Whether frozen or thawed 
vegetables are typically consumed raw is not relevant to the analysis.
5. Specific Produce Commodities and Sec. Sec.  112.2(a) and 112.2(b)
    (Comment 68) Several comments request that we consider or 
reconsider our treatment of certain commodities as covered produce or 
rarely consumed raw (and therefore not covered produce), where such 
commodities are those for which data about uncooked consumption is 
available. Some comments request removing the following commodities 
from the list of rarely consumed raw produce so that they would be 
covered produce, stating that such commodities are regularly consumed 
raw: asparagus, beets (including, specifically, beet greens), bok choy, 
Brussels sprouts, collard greens, figs, ginger root, rhubarb, sweet 
corn, turnips (roots and greens), and water chestnuts. Some comments 
specifically asked FDA to finalize its tentative conclusion that bean 
sprouts are covered produce and are not exempt as rarely consumed raw 
produce. On the other hand, some comments request exempting the 
following commodities as rarely consumed raw that were not in FDA's 
proposed list: almonds, burdock roots, olives, pecans, pistachios, 
soybean beans, sunflower seeds, walnuts, and yuca.
    (Response) NHANES/WWEIA data are available with respect to uncooked 
consumption of each of these commodities. Based on the analysis 
described previously (see our response to Comment 64), asparagus, beets 
(garden (roots and tops)), beet (sugar), collards, figs, ginger, sweet 
corn, and water chestnuts are reported consumed (all forms, taken 
together) by more than 1 percent weighted number of survey respondents, 
and consumed uncooked by less than 0.1 percent of the United States 
population, and consumed uncooked on less than 0.1 percent of eating 
occasions (Ref. 73). Therefore, despite commenters' suggestions that 
these commodities might not meet the criteria for rarely consumed raw, 
they are in fact rarely consumed raw per our established criteria (see 
column 1 of Table 5) and they are therefore included in the list in 
Sec.  112.2(a)(1).
    On the other hand, bok choy, Brussels sprouts, rhubarb, and turnip, 
all of which we had proposed as rarely consumed raw commodities are now 
shown, using the more recent NHANES/WWEIA data and applying our revised 
criteria for rarely consumed raw, not to satisfy our criteria for 
rarely consumed raw produce (Ref. 73).
    Bok choy does not meet our revised criteria for rarely consumed raw 
in that less than 1 percent weighted number of survey respondents 
reported consumption of this commodity in any form. Therefore, we are 
removing bok choy from the list of rarely consumed raw produce in Sec.  
112.2(a)(1). Instead, bok choy is covered produce subject to the 
requirements of part 112 as applicable.
    For Brussels sprouts, in the 2013 proposed rule, we based our 
tentative conclusion that they are rarely consumed raw on the lack of 
an uncooked code reported in the 1999-2006 NHANES/WWEIA dataset. (We 
note that we incorrectly described our categorization of this commodity 
in the 2013 proposed rule in a way that did not affect the ultimate 
result, but did affect the reason given for that result (Ref. 73)). In 
contrast, the current NHANES/WWEIA datasets provide quantitative 
information about uncooked consumption of Brussels sprouts, which shows 
that they do not meet the revised criteria for rarely consumed raw in 
that less than 1 percent weighted number of survey respondents reported 
consumption of this commodity in any form. Therefore, we are removing 
Brussels sprouts from the list of rarely consumed raw produce in Sec.  
112.2(a)(1). Instead, Brussels sprouts are covered produce subject to 
the requirements of part 112 as applicable.
    We did not propose to exempt sprouts as rarely consumed raw and we 
are not changing this conclusion. Alfalfa sprouts do not meet the first 
two criteria for rarely consumed raw. Mung bean sprouts also do not 
meet the first two criteria for rarely consumed raw. Soybean sprouts 
meet the first two criteria for rarely consumed raw but do not meet the 
third criterion in that less than 1 percent weighted number of survey 
respondents reported consumption of this commodity in any form (Ref. 
73). Sprouts are covered produce subject to the requirements of part 
112 as applicable, including those in subpart M.
    With respect to requests to add new commodities for which uncooked 
consumption data are available to the rarely consumed raw list, we 
analyzed the data and agree that pecans meet the revised criteria for 
rarely consumed raw (see Table 5) (Ref. 73). Therefore, we have added 
pecans to the list in Sec.  112.2(a)(1).
    On the other hand, almonds, olives, pistachios, walnuts, and yuca 
(cassava) do not meet the first two criteria for rarely consumed raw 
(Ref. 73). Burdock meets the first two criteria for rarely consumed raw 
but does not meet the third criterion in that less than 1 percent 
weighted number of survey respondents reported consumption of this 
commodity in any form (Ref. 73). Therefore, these commodities are not 
included in the list of rarely consumed raw commodities in Sec.  
112.2(a)(1) and, instead, are covered produce subject to

[[Page 74393]]

the requirements of part 112 as applicable. (Note that we consider 
oilseeds, such as soybeans and sunflower seeds, to be grains and 
therefore not ``produce'' (see our response to Comment 58).
    Note that our analysis of beets (garden), dasheen (or taro), 
turnips, and chicory accounts for both roots and greens, collectively, 
of each commodity. Similarly, our analysis for dill accounts for both 
seeds (dill seed) and greens (dillweed) (Ref. 73). Although for each of 
these commodities, NHANES/WWEIA includes separate reported entries for 
``roots'' and ``tops'' (and for dill, NHANES/WWEIA includes separate 
entries for ``dill seed'' and ``dillweed''), for purposes of 
determining coverage under this rule, we find it appropriate to analyze 
consumption collectively to account for the entire harvested or 
harvestable portion of the plant. Based on our analysis using the 
combined data for roots and tops for each of these commodities, we 
conclude that beets (garden (roots and tops)) and dill (seeds and weed) 
are rarely consumed raw (see column 1 of Table 5). Therefore, beets 
(garden) and dill listed under Sec.  112.2(a)(1) specify ``root and 
tops'' and ``seeds and weed'', respectively. Conversely, dasheen (corm 
and leaves), chicory (roots and tops), and turnip (roots and tops) do 
not meet our criteria for rarely consumed raw. Regarding dasheen (or 
taro), we had proposed to exempt ``taro'' as rarely consumed raw in the 
2013 proposed rule. However, based on the current NHANES/WWEIA 
datasets, dasheen (corm and leaves) does not meet our revised criteria 
for rarely consumed raw in that although it meets the first two 
criteria, it does not meet the third criterion. Similarly, we had 
proposed to exempt turnip as rarely consumed raw in the 2013 proposed 
rule. However, based on the current NHANES/WWEIA datasets, turnip 
(roots and greens) does not meet our revised criteria for rarely 
consumed raw in that although it meets the first two criteria, it does 
not meet the third criterion. Therefore, we are removing ``taro'' and 
``turnip'' from the list of rarely consumed raw produce in Sec.  
112.2(a)(1). Instead, both dasheen (corm and leaves) and turnip (roots 
and greens) are covered produce subject to the requirements of part 112 
as applicable.
    In addition, two other commodities (i.e., artichokes and plantains) 
that we had proposed to exempt as rarely consumed raw produce (based on 
previously available uncooked consumption data) are now not on our 
final list in Sec.  112.2(a)(1) because less than 1 percent weighted 
number of survey respondents report consumption of these commodities in 
any form and therefore they do not meet our revised criteria for rarely 
consumed raw (Ref. 73). Artichoke is reported in the current NHANES/
WWEIA datasets under two separate entries: Artichoke, Jerusalem, for 
which there is quantitative information on uncooked consumption, and 
Artichoke, globe for which there is no ``uncooked'' consumption code. 
Neither Artichoke, Jerusalem nor Artichoke, globe meets our revised 
criteria for rarely consumed raw in that although both meet the first 
two criteria, they do not meet the third criterion. Likewise, plantain, 
for which there is quantitative information on uncooked consumption, 
does not meet our revised criteria for rarely consumed raw in that 
although it meets the first two criteria, it does not meet the third 
criterion (Ref. 73). (See also Comment 69 for other commodities for 
which there is no reported ``uncooked'' consumption code that we 
proposed to exempt as rarely consumed raw but that are not on our final 
rarely consumed raw list).
    (Comment 69) Several comments request that we consider or 
reconsider our treatment of certain commodities as covered produce or 
rarely consumed raw (and therefore not covered produce), where such 
commodities are those reported in NHANES/WWEIA data but for which there 
is no ``uncooked'' consumption category reported. Several comments 
argue that kale, which was on the proposed list of rarely consumed raw 
produce, has greatly grown in popularity and is often consumed raw. 
These comments provide various types of evidence that kale is 
frequently consumed raw by United States consumers, and recommend 
removing kale from the list of rarely consumed raw produce such that it 
would be ``covered produce'' subject to the requirements of part 112. 
Some comments also suggested removing parsnips from the list of rarely 
consumed raw produce for similar reasons. On the other hand, some 
comments request exempting brazil nuts, breadfruit, cashews, chestnuts, 
hazelnuts, macadamia nuts, palm heart leaves (palm heart, palmito, 
chonta, or jebato), peppermint (mint), pigeon peas, and pine nuts as 
rarely consumed raw. Finally, some comments ask that FDA finalize its 
conclusion that peanuts are rarely consumed raw without change.
    (Response) As discussed previously (under Comment 64), we have 
concluded that commodities included in the NHANES/WWEIA datasets for 
which categories of reported consumption in the NHANES/WWEIA surveys do 
not include ``uncooked'' can be reasonably considered to fall beneath 
the numerical thresholds of being consumed uncooked by less than 0.1 
percent of the United States population and consumed uncooked on less 
than 0.1 percent of eating occasions because lack of an ``uncooked'' 
reported food form indicates that they were not consumed uncooked in 
any measurable quantity by most consumers across the United States. To 
such commodities, we applied the new numerical threshold of weighted 
number of survey respondents of at least 1 percent of the total number 
of survey respondents having reported consumption of the commodity in 
any form.
    Brazil nuts, breadfruit, cashews, chestnuts, hazelnuts, kale, 
macadamia nuts, palm heart leaves, parsnips, peanuts, peppermint, 
pigeon peas, and pine nuts are all commodities included in the NHANES/
WWEIA datasets for which categories of reported consumption in the 
NHANES/WWEIA surveys do not include ``uncooked.'' We find brazil nuts, 
breadfruit, chestnut, kale, macadamia nuts, palm heart leaves, 
parsnips, pigeon peas, and pine nuts do not meet our revised criteria 
for rarely consumed raw in that less than 1 percent weighted number of 
survey respondents reported consumption of these commodities in any 
form (Ref. 73). In contrast, cashews, hazelnuts, peanuts, and 
peppermint meet the revised criteria for rarely consumed raw in that 
more than 1 percent weighted number of survey respondents reported 
consumption of these commodities in any form (Ref. 73).
    Therefore, we conclude that brazil nuts, breadfruit, chestnuts, 
kale, macadamia nuts, palm heart leaves, parsnips, pigeon peas, and 
pine nuts do not meet the criteria for rarely consumed raw and we do 
not include them in the list in Sec.  112.2(a)(1). Instead, these 
commodities are covered produce subject to the requirements of part 112 
as applicable. We also conclude that cashews, hazelnuts, peanuts, and 
peppermint are rarely consumed raw and, therefore, we include them in 
the list in Sec.  112.2(a)(1). See column 2 of Table 5. (We note that 
hazelnuts have been associated with one outbreak in 2010-2011 (Ref. 
28); however, hazelnuts meet our criteria for rarely consumed raw, 
which are based on consumption of produce commodities by U.S. consumers 
as indicated by NHANES/WWEIA surveys, as described in response to 
Comment 64. While hazelnuts are exempt from this rule under Sec.  
112.2(a)(1), we note that the FD&C Act still applies to the production 
of hazelnuts.)

[[Page 74394]]

    In addition, five other commodities that we proposed to exempt as 
rarely consumed raw based on lack of uncooked code reported in the 
previous NHANES/WWEIA dataset are now not on our final list in Sec.  
112.2(a)(1). Black-eyed pea (or cowpea bean) does not meet the revised 
criteria for rarely consumed raw in that less than 1 percent weighted 
number of survey respondents reported consumption of this commodity in 
any form (Ref. 73). Crabapple is not a survey item in the current 
NHANES/WWEIA datasets, so we have no current data to which the revised 
criteria for rarely consumed raw may be applied for this commodity. 
Rhubarb, rutabaga, and yam also do not meet our revised criteria for 
rarely consumed raw in that less than less than 1 percent weighted 
number of survey respondents reported consumption of these commodities 
in any form (Ref. 73). Therefore, we are removing black-eyed pea, 
crabapple, rhubarb, rutabaga, and yam from the list of rarely consumed 
raw produce in Sec.  112.2(a)(1). Instead, these commodities are 
covered produce subject to the requirements of part 112 as applicable. 
We intend to review the status of these commodities upon availability 
of updated dietary consumption information, including data obtained 
from NHANES/WWEIA 2015-2016 surveys. We encourage stakeholders who may 
have data or information relevant to this analysis to consult with us. 
(See also Comment 68 for other commodities for which there is 
quantitative information on uncooked consumption that we proposed to 
exempt as rarely consumed raw but that are not on our final rarely 
consumed raw list).
    (Comment 70) Some comments requested exemption of coffee beans and 
hops as rarely consumed raw because they are typically consumed in 
beverage form as coffee and beer, respectively.
    (Response) As discussed previously (under Comment 64), we are 
adding coffee beans to the list of exempt commodities in Sec.  
112.2(a)(1). The consumption of coffee beans is reported in the NHANES/
WWEIA only in roasted form as the beverage, coffee. Similarly, the 
consumption of cocoa beans is only reported as cocoa beverage, 
chocolate beverage, chocolate, or related products. We conclude that 
these commodities are rarely consumed raw because the only forms in 
which they are reported in the NHANES/WWEIA surveys indicates they were 
cooked as part of the process of being made into the identified 
processed foods (such that we infer that they were not consumed 
uncooked in any measurable quantity), and they satisfy the new 
numerical threshold (i.e., at least 1 percent of weighted number of 
survey respondents must have reported consuming the commodity in any 
form for the data to provide a reasonable representation of how that 
commodity is consumed by U.S. consumers). We are therefore adding them 
to the list of rarely consumed raw produce in Sec.  112.2(a)(1) (see 
column 3 of Table 5). On the other hand, while the consumption of hops 
is reported in the NHANES/WWEIA only in beverage form as beer, we 
cannot conclude that this indicates that hops were cooked as part of 
the process of being made into beer. We are aware that hops are 
regularly added to beer after all cook steps are completed in a process 
known as ``dry hopping'' (Ref. 90). Therefore it would not be 
reasonable to infer on this basis that hops were not consumed uncooked 
in any measurable quantity by most consumers across the United States, 
and we are not adding hops to the list of rarely consumed raw produce. 
Instead, hops are covered produce subject to the requirements of part 
112 as applicable. However, we note that hops used in the making of 
beer will be eligible for exemption from the requirements of part 112 
under the provisions of Sec.  112.2(b)(1), provided the covered farm 
establishes and maintains documentation in accordance with Sec.  
112.2(b)(2). Brewing beer adequately reduces the presence of 
microorganisms of public health significance through means other than a 
cook step (e.g., pH, alcohol content, fermentation) (Ref. 88). We are 
adding this to our list of examples of products of commercial 
processing in Sec.  112.2(b)(1).
    (Comment 71) Some comments request exempting the following 
commodities that are not covered in the NHANES/WWEIA datasets as rarely 
consumed raw: ackee, aronia, atemoya, butterbur, chipilin, dragon 
fruit, fiddleheads, ginkgo nut, komatsuna, longan, loroco, pomelo, 
ramp, tamarillo, ti plant, and ulluko (melloco). We also received 
comments asking about the status of lotus root and swamp cabbage.
    (Response) As discussed previously (under Comment 64), where a 
commodity is not included in the NHANES/WWEIA data at all, we have no 
robust, nationally-representative data from which to determine whether 
or not such foods are typically consumed cooked among United States 
consumers, and commenters did not provide any such information. As a 
result, we are not exempting ackee, aronia, atemoya, butterbur, 
chipilin, dragon fruit, fiddleheads, ginkgo nut, komatsuna, longan, 
loroco, pomelo, ramp, tamarillo, ti plant, or ulluko (melloco) (Ref. 
73). Instead, they are covered produce subject to the requirements of 
part 112 as applicable.
    While lotus root and swamp cabbage are reported in NHANES, they are 
reported only in cooked forms, and there are no data from which their 
raw consumption may be analyzed. However, neither commodity satisfies 
the third criterion in that less than 1 percent weighted number of 
survey respondents reported consumption of these commodities in any 
form (Ref. 73).
    Two other commodities that we proposed, in the 2013 proposed rule, 
to exempt as rarely consumed raw based on non-NHANES data and other 
references are arrowhead and arrowroot. Neither of these commodities is 
reported in the current NHANES/WWEIA datasets, and we have no data to 
which the revised criteria for rarely consumed raw may be applied for 
these commodities. Therefore, we are removing arrowhead and arrowroot 
from the list of rarely consumed raw produce in Sec.  112.2(a)(1). 
Instead, arrowhead and arrowroot are covered produce subject to the 
requirements of part 112 as applicable.
    We intend to consider updating the list of rarely consumed raw 
commodities in the future as appropriate, such as if new data become 
available. We encourage stakeholders who have information relevant to 
consumption of these produce commodities to identify relevant data for 
FDA's review and evaluation. To be useful, such data would need to be 
sufficiently robust and representative of consumption of relevant 
commodities by consumers across the United States to allow us to draw 
scientifically valid conclusions.
    (Comment 72) One comment argues that, although tree fruits and 
berries are frequently consumed raw, they should nevertheless be added 
to the list of ``rarely consumed raw'' as being ``low-risk'' because, 
according to the comment, as long as ground irrigation is used there is 
no scientific evidence that E. coli or other bacterial contamination 
can be carried through the roots to the fruit, which the comment 
contrasts with lettuce and other leafy green vegetables. The comment 
adds that all consumers should be aware of the need to wash produce 
before consumption to prevent foodborne illnesses.
    (Response) Our criteria for determining which produce commodities 
are rarely consumed raw relate only to the frequency with which produce 
commodities are consumed uncooked and not to commodity characteristics, 
agricultural practices, or other consumer practices (such as washing) 
as suggested by the comment.

[[Page 74395]]

We do not agree that either tree fruits generally or berries generally 
should be considered to be exempt as rarely consumed raw for the 
reasons suggested by the comment. In section IV of this document, we 
address our integrated approach and how it reflects relevant 
differences across commodities, such as the use of agricultural 
practices presenting varying levels of risk.
    (Comment 73) Several comments urge FDA to exempt wine grapes as 
rarely consumed raw. These comments state that wine grapes are not 
grown or selected for raw consumption, but rather are selected for 
properties that make good wine. According to these comments, winemakers 
select specific grape varietals based on skin, color, and texture, 
among other things, and virtually all wine grapes are grown, harvested, 
and then delivered for processing at a winery rather than sold into the 
fresh market. These comments state that wine grapes are substantially 
different from grape cultivars selected for fresh consumption in that 
wine grapes usually have seeds, and have thick skins and high sugar 
content. These comments also cite wine's inherent anti-microbial 
properties and a lack of evidence of microbial illness resulting from 
either wine grapes or wine, to argue that wine grapes should be exempt 
from the standards established under this rule under proposed Sec.  
112.2(b) for produce that receives commercial processing that 
adequately reduces pathogens.
    (Response) Based on the data available to us, we do not agree that 
wine grapes meet the criteria for rarely consumed raw. Uncooked 
consumption data are available for ``grapes, wine and sherry'' in the 
2003-2010 NHANES/WWEIA datasets, and our analysis shows that ``grapes, 
wine and sherry'' do not meet the first two criteria for rarely 
consumed raw (Ref. 73). Although this category (``grapes, wine and 
sherry'') includes grapes used in the making of both wine and sherry, 
we consider the NHANES/WWEIA data to be the best data available for 
this purpose, and using this data it appears that ``wine grapes'' do 
not meet the criteria for rarely consumed raw. We do not have 
information on the specific grape cultivars or varieties that are 
solely and exclusively grown for use in winemaking that would allow us 
to establish a category covering only ``wine grapes'' and evaluate 
their eligibility using currently available dietary consumption data. 
In addition, according to the National Grape Registry (Ref.91), many 
Vitis vinifera cultivars are multi-purpose in use. For example, the 
Malvasia Bianca grape cultivar can be used as a wine grape or a table 
grape, and the Muscat of Alexandria grape cultivar can be used to make 
wine or raisins, or as a table grape. For these reasons, FDA concludes 
that ``wine grapes'' are not rarely consumed raw, and we do not include 
them in Sec.  112.2(a)(1). Instead, wine grapes are covered produce 
subject to the requirements of part 112 as applicable.
    However, we note that grapes used in the making of wine are 
eligible for exemption from the requirements of part 112 under the 
provisions of Sec.  112.2(b)(1), provided the covered farm takes the 
required steps in accordance with Sec.  112.2(b). Winemaking adequately 
reduces the presence of microorganisms of public health significance 
through means other than a cook step (e.g., pH, alcohol content, 
fermentation) (Ref. 88). We are adding this to our list of examples of 
products of commercial processing in Sec.  112.2(b)(1).

B. Definitions Other Than Small Business, Very Small Business, and 
Produce (Sec.  112.3(c))

    In the 2013 proposed rule, under proposed Sec.  112.3(c), we 
proposed to establish the various definitions that would apply for the 
purposes of part 112 (78 FR 3504 at 3539-3549). In addition, in the 
supplemental notice, taking into account public comment, we proposed to 
amend our originally proposed definitions of ``covered activity,'' 
``farm,'' ``harvesting,'' ``holding,'' and ``packing'' in proposed 
Sec.  112.3(c) (79 FR 58434 at 58438-58440). In both the 2013 proposed 
rule and in the supplemental notice, we asked for public comment on our 
proposed definitions.
    In this section of this document we discuss comments that we 
received on the definitions proposed in the 2013 proposed rule, but 
that we did not address in the supplemental notice. We also discuss 
comments that we received on the amended proposed definitions in the 
supplemental notice.
    Several comments received in response to the amended proposed 
definitions of ``farm,'' ``harvesting,'' ``packing,'' and ``holding'' 
in the supplemental notice are also the same comments we received in 
response to those amended proposed definitions in the supplemental 
human preventive controls notice. Because we already considered and 
discussed these comments in the final human preventive controls rule 
that established revised definitions for ``farm,'' ``manufacturing/
processing,'' ``harvesting,'' ``packing,'' and ``holding'' in Sec.  
1.227 (Ref. 11), and because we are adopting definitions of these terms 
in this rule that are the same as the definitions established in the 
final human preventive controls rule, in this section of this document, 
we focus on comments related to these definitions that are specific to 
part 112 that were not otherwise addressed in the final human 
preventive controls rule.
1. Definitions of Farm and Related Terms (Manufacturing/Processing, 
Harvesting, Holding, and Packing)
    We revised the proposed definitions of farm, manufacturing/
processing, harvesting, holding, and packing in the final human 
preventive controls rule (see 80 FR 55908 at 55925-55936), and 
established the revised definitions in Sec. Sec.  1.227 and 117. We are 
adopting the same definitions of farm, manufacturing/processing, 
harvesting, holding, and packing established in Sec.  1.227 for 
purposes of the PCHF regulation, now in Sec.  112.3(c) for purposes of 
the Produce Safety regulation.
    Definition of ``farm.'' In the supplemental notice, taking into 
account public comment on our proposed definition of ``farm'' in the 
2013 proposed rule and consistent with our proposed amendments to the 
definition of ``farm'' as it applies to proposed part 117, we proposed 
to amend the definition of ``farm'' in proposed Sec.  112.3(c) such 
that establishments that pack or hold produce that is grown or 
harvested on another farm would be subject to the produce safety 
standards of proposed part 112 regardless of whether or not that farm 
is under the same ownership.
    We proposed to amend the originally proposed definition of farm to 
mean ``an establishment under one ownership in one general physical 
location devoted to the growing and harvesting of crops, the raising of 
animals (including seafood), or both. The term ``farm'' as proposed in 
the supplemental notices would include establishments that, in addition 
to these activities: (1) Pack or hold RACs; (2) Pack or hold processed 
food, provided that all processed food used in such activities is 
either consumed on that farm or another farm under the same ownership, 
or is processed food identified in paragraph (iii)(B)(1) of the 
``farm'' definition; and (3) Manufacture/process food, provided that:
    [ssquf] All food used in such activities is consumed on that farm 
or another farm under the same ownership; or
    [ssquf] Any manufacturing/processing of food that is not consumed 
on that farm or another farm under the same ownership consists only of:
    [cir] Drying/dehydrating RACs to create a distinct commodity, and 
packaging

[[Page 74396]]

and labeling such commodities, without additional manufacturing/
processing; and
    [cir] Packaging and labeling RACs, when these activities do not 
involve additional manufacturing/processing.
    Even after the revisions we proposed in the supplemental notice and 
the supplemental human preventive controls notice, some comments 
asserted that the overall ``farm'' definition still presented an 
unrealistic and incomplete understanding of how most farms in the 
United States are structured with regard to their physical location(s) 
and business models. Most of the comments suggested alternative or 
additional regulatory text or asked us to clarify how we will interpret 
the provisions. After considering these comments, we revised our 
proposed definition of ``farm'' (as well as the definitions of 
``manufacturing/processing,'' ``harvesting,'' ``packing,'' and 
``holding'') and have established the revised definition in Sec.  
1.227, as explained in section IV of the final human preventive 
controls rule (80 FR 55908). In that document, we discussed in detail 
our consideration of comments received and revisions to our proposed 
definitions of ``farm'' (and of ``manufacturing/processing,'' 
``harvesting,'' ``packing,'' and ``holding''). See also relevant 
discussion in section V of the final human preventive controls rule, 
where we respond to comments on the organizing principles for how the 
status of a food as a RAC or as a processed food affects the 
requirements applicable to a farm under sections 415 and 418 of the 
FD&C Act.
    Consistent with the definition of ``farm'' in Sec.  1.227, we are 
defining ``farm'' in Sec.  112.3(c) to indicate that there are two 
types of farms: (1) A Primary Production Farm and (2) a Secondary 
Activities Farm. A Primary Production Farm is an operation under one 
management in one general (but not necessarily contiguous) physical 
location devoted to the growing of crops, the harvesting of crops, the 
raising of animals (including seafood), or any combination of these 
activities. In addition to these activities, the term ``farm'' includes 
operations that (1) pack or hold raw agricultural commodities; (2) pack 
or hold processed food, provided that all processed food used in such 
activities is either consumed on that farm or another farm under the 
same management, or is processed food as described below, and (3) 
manufacture/process food, provided that all food used in such 
activities is consumed on that farm or another farm under the same 
management; or any manufacturing/processing of food that is not 
consumed on that farm or another farm under the same management 
consists only of the following: drying/dehydrating raw agricultural 
commodities to create a distinct commodity (such as drying/dehydrating 
grapes to produce raisins), and packaging and labeling such 
commodities, without additional manufacturing/processing (an example of 
additional manufacturing/processing is slicing); treating to manipulate 
the ripening of raw agricultural commodities (such as by treating 
produce with ethylene gas), and packaging and labeling treated raw 
agricultural commodities, without additional manufacturing/processing; 
and packaging and labeling raw agricultural commodities, when these 
activities do not involve additional manufacturing/processing (an 
example of additional manufacturing/processing is irradiation). A 
Secondary Activities Farm is an operation, not located on a Primary 
Production Farm, devoted to harvesting (such as hulling or shelling), 
packing, and/or holding of raw agricultural commodities, provided that 
the Primary Production Farm(s) that grows, harvests, and/or raises the 
majority of the raw agricultural commodities harvested, packed, and/or 
held by the Secondary Activities Farm owns, or jointly owns, a majority 
interest in the Secondary Activities Farm. A Secondary Activities Farm 
may also conduct those additional activities allowed on a Primary 
Production Farm.
    (Comment 74) Some comments ask us to use the phrase ``jointly 
controlled farm business operation'' within the farm definition and to 
define it ``as a business that supplies raw agricultural commodities 
and is majority controlled by two or more farm operators.''
    (Response) We do not see the need to define ``jointly controlled 
farm business operation'' or to use it in the farm definition, given 
the revisions to the farm definition explained in the final human 
preventive controls rule, and ``farm'' as defined does not refer to 
farm operators.
    (Comment 75) Some comments request the revised proposed farm 
definition should not result in foreign f arms being considered to be a 
part of a domestic farm under the same ownership.
    (Response) There are two relevant considerations in the revised 
``farm'' definition. First, in the revised ``farm'' definition 
established in Sec.  1.227, we replaced the phrase ``under one 
ownership'' in the proposed ``farm'' definition with the phrase ``under 
one management.'' Although the original phrase ``under one ownership'' 
was not referring to a single owner, we agreed that the ``farm'' 
definition should reflect modern business models (such as cooperatives, 
on-farm packinghouses under ownership by multiple farms, food 
aggregators, and food hubs) and use language that the modern farming 
community understands (80 FR 55908 at 55925-55932). Second, a ``farm'' 
is defined to be in ``one general physical (but not necessarily 
contiguous) location.'' While a domestic farm and foreign farm might be 
under the same management for purposes of the business model, they 
would not likely be in the same general location, unless the farm 
straddled an international border. So, we believe it is unlikely that a 
domestic and foreign farm with the same owner would be considered a 
single farm under the revised definition.
    (Comment 76) Some comments point to the inconsistency in treatment 
of packing and holding of produce that occurs on a farm versus at an 
off-farm location using the same practices even though there is no 
difference in risk. Some comments suggest adding a new paragraph to 
Sec.  112.4 that extends the produce safety rule to registered 
establishments that perform holding and packing activities of covered 
produce consistent with covered activities performed by a farm, but not 
growing or harvesting activities. Other comments suggest, 
alternatively, providing an exemption from part 117 for those off-farm 
activities that adhere to the produce safety standards in part 112, if 
appropriate documentation is maintained.
    (Response) Under the revised definition of ``farm'' we established 
in Sec.  1.227, an operation devoted only to the harvesting (such as 
hulling or shelling), packing, and/or holding of RACs is within the 
``farm'' definition, provided that the farms that grow or raise the 
majority of the RACs harvested, packed, and/or held by the operation 
own, or jointly own, a majority interest in the operation. See 
``secondary activities farm'' within the farm definition. Under this 
definition, off-site packinghouses that are managed by a business 
entity (such as a cooperative) that is different from the business 
entity growing crops (such as individual farms) can be within the 
``farm'' definition provided that the ownership criteria are met. We 
are adopting this definition of farm in Sec.  112.3(c).
    (Comment 77) Another comment asks to clarify that ``produce'' does 
not include wild-harvested produce where produce is not cultivated but 
harvested wild, such as some blueberries.

[[Page 74397]]

    (Response) Under the revised definition of ``farm'' we established 
in Sec.  1.227, an operation that is devoted only to the harvesting of 
covered produce grown in the wild is within the ``farm'' definition. We 
are adopting this definition of farm in Sec.  112.3(c). Because, in 
this circumstance, the farm is not engaged in the growing of the 
covered produce, the standards in part 112 relating to growing 
activities do not apply to such a farm (see Sec.  112.4(a), providing 
that covered farms subject to part 112 must comply with all applicable 
requirements when conducting a covered activity on covered produce). 
However, the harvesting activity and any other covered activities 
conducted by the farm on covered produce are required to comply with 
those requirements in part 112 that are applicable. We also expect that 
a large proportion of such operations (i.e., those that harvest covered 
produce grown in the wild) may not be covered under this rule (see 
Sec.  112.4(a)) or may be eligible for a qualified exemption (see Sec.  
112.5) based on their size.
    (Comment 78) In the supplemental notice, we requested comment on 
whether to include in the final rule a requirement that a farm 
supplying produce to another farm that will pack or hold that produce 
should provide to the farm that receives the produce its name, complete 
business address, and description of the produce in any individual 
shipment (79 FR 58434 at 58440). Several comments express concern that 
the proposed definition of ``farm'' would negatively impact the ability 
to trace produce, and ask FDA to ensure it has access to necessary 
records to fulfill its public health goals. One commenter supports 
requiring records that identify the immediate previous source and 
subsequent recipient of the produce to allow timely and effective 
recalls, when needed. Another commenter argues that FSMA does not 
authorize FDA to require traceability records for all covered farms, 
and states that, if we decide to require farms that pack and hold RACs 
from other farms to maintain records for traceability purposes, the 
record requirements: (1) Should not exceed a one-up-one-down record of 
the transaction; (2) should be limited to those documents generated in 
the ordinary course of business; (3) should not include records 
retention for more than one year; and (4) should allow written records, 
and not require electronic records.
    (Response) At this time, we are not requiring documentation when a 
covered farm packs or holds covered produce from a farm under a 
different management. We recognize that many small or very small farms 
may routinely pack or hold produce grown and harvested at a neighbor's 
farm or at a farm that is not under their management, as a course of 
business or when necessary to fulfill a specific volume of produce to 
be delivered to their supplier. We encourage covered farms to keep and 
maintain a documentation of such exchange of covered produce, but we do 
not believe a requirement for the covered farm to maintain 
documentation of each such transaction is warranted at this time given 
the small volume of produce that we expect would fall under such 
scenarios and their likely minimal contribution to the overall produce 
in the marketplace. We note that, under the Perishable Agricultural 
Commodities Act (PACA), which is administered by USDA, there are 
certain recordkeeping requirements for persons who buy or sell more 
than 2,000 pounds of fresh or frozen fruits and vegetables in any given 
day. Such records may be helpful in the event of a traceback. In 
addition, section 204 of FSMA mandates that FDA conduct a rulemaking on 
additional recordkeeping requirements for tracing of certain high risk 
foods. We will address issues related to traceability of high risk 
foods, in that rulemaking.
    (Comment 79) One comment asks if FDA can consider a group of farms 
in one general location as one farm to lessen the cost of compliance.
    (Response) A ``farm'' is defined for purposes of this rule in Sec.  
112.3(c), and all covered farms are required to comply with all 
applicable requirements of this rule. We encourage farms to work 
together to help each other achieve compliance to the extent 
practicable. For example, this rule allows for sharing water testing 
data under certain circumstances (see Sec.  112.47(a)). In addition, 
farms may find it useful to share training materials or record 
templates. We are aware of certain pilot projects using a collaborative 
model, and we encourage industry to explore these innovative approaches 
to help achieve compliance. For example, AMS is piloting a Group GAP 
Certification Program (Ref. 92).
    Definition of ``manufacturing/processing''. In the final human 
preventive controls rule, we revised our proposed definition of 
``manufacturing/processing'' (which we proposed in the 2013 proposed 
rule and the supplemental human preventive controls notice) in relation 
to our revision to the farm definition. We have established the revised 
definition in Sec.  1.227, as explained in section IV of the final 
human preventive controls rule (80 FR 55908 at 55934-55935). In that 
document, we discussed in detail our consideration of comments received 
and revisions to our proposed definition of ``farm'' and the 
corresponding revisions to the proposed definition of ``manufacturing/
processing.''
    Consistent with the definition of ``manufacturing/processing'' in 
Sec.  1.227, we are defining ``manufacturing/processing'' in Sec.  
112.3(c) to mean ``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 include: Baking, boiling, bottling, canning, 
cooking, cooling, cutting, distilling, drying/dehydrating raw 
agricultural commodities to create a distinct commodity (such as 
drying/dehydrating grapes to produce raisins), evaporating, 
eviscerating, extracting juice, formulating, freezing, grinding, 
homogenizing, labeling, milling, mixing, packaging (including modified 
atmosphere packaging), pasteurizing, peeling, rendering, treating to 
manipulate ripening, trimming, washing, or waxing. For farms and farm 
mixed-type facilities, manufacturing/processing does not include 
activities that are part of harvesting, packing, or holding.''
    Definition of ``harvesting''. In the supplemental notice, taking 
into account public comment on our proposed definition of 
``harvesting'' in the 2013 proposed rule and consistent with our 
proposed amendments to the definition of ``harvesting'' as it applies 
to proposed part 117, we proposed to amend the definition of 
``harvesting'' in proposed Sec.  112.3(c).
    We proposed to amend the originally proposed definition of 
``harvesting'' to apply to farms and farm mixed-type facilities and to 
mean activities that are traditionally performed on farms for the 
purpose of removing [RACs] from the place they were grown or raised and 
preparing them for use as food. Harvesting is limited to activities 
performed on [RACs] on a farm. Harvesting does not include activities 
that transform a [RAC], as defined in section 201(r) of the [FD&C Act] 
(21 U.S.C. 321(r)), into a processed food as defined in section 201(gg) 
of the [FD&C Act]. Gathering, washing, trimming of outer leaves of, 
removing stems and husks from, sifting, filtering, threshing, shelling, 
and cooling [RACs] grown on a farm are examples of harvesting.
    In response to the supplemental notice and the supplemental human 
preventive controls notice, some

[[Page 74398]]

comments asked us to consider additional activities within the 
``harvesting'' definition and to provide more examples of harvesting 
activities, in the regulatory text and in guidance. After considering 
these comments, we revised our proposed definition of ``harvesting'' 
and have established the revised definition in Sec.  1.227, as 
explained in section IV of the final human preventive controls rule (80 
FR 55908 at 55932-55933). In that document, we discussed in detail our 
consideration of comments received and revisions to our proposed 
definition of ``harvesting''.
    Consistent with the definition of ``harvesting'' in Sec.  1.227, we 
are defining ``harvesting'' in Sec.  112.3(c) to apply to farms and 
farm mixed-type facilities and to mean ``activities that are 
traditionally performed on farms for the purpose of removing raw 
agricultural commodities from the place they were grown or raised and 
preparing them for use as food. Harvesting is limited to activities 
performed on raw agricultural commodities, or on processed foods 
created by drying/dehydrating a raw agricultural commodity without 
additional manufacturing/processing, on a farm. Harvesting does not 
include activities that transform a raw agricultural commodity into a 
processed food as defined in section 201(gg) of the [FD&C Act]. 
Examples of harvesting include cutting (or otherwise separating) the 
edible portion of the raw agricultural commodity from the crop plant 
and removing or trimming part of the raw agricultural commodity (e.g., 
foliage, husks, roots or stems). Examples of harvesting also include 
cooling, field coring, filtering, gathering, hulling, removing stems 
and husks from, shelling, sifting, threshing, trimming of outer leaves 
of, and washing raw agricultural commodities grown on a farm.''
    (Comment 80) Some comments ask us to include field coring as an 
example of harvesting activity, consistent with the definition proposed 
in the supplemental human preventive controls notice.
    (Response) The revised definition of harvesting in Sec.  1.227, 
which we are adopting in Sec.  112.3(c), includes field coring in the 
list of examples of harvesting.
    Definition of ``holding.'' In the supplemental notice, taking into 
account public comment on our proposed definition of ``holding'' in the 
2013 proposed rule and consistent with our proposed amendments to the 
definition of ``holding'' as it applies to proposed part 117, we 
proposed to amend the definition of ``holding'' in proposed Sec.  
112.3(c).
    We proposed to amend the definition of ``holding'' to mean 
``storage of food and also includes activities performed incidental to 
storage of a food (e.g., activities performed for the safe or effective 
storage of that food and activities performed as a practical necessity 
for the distribution of that food (such as blending of the same [RACs] 
and breaking down pallets)), but does not include activities that 
transform 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]. 
Holding facilities could include warehouses, cold storage facilities, 
storage silos, grain elevators, and liquid storage tanks.''
    In response to the supplemental notice and the supplemental human 
preventive controls notice, some comments asked us to consider 
additional activities within the ``holding'' definition and to provide 
more examples of holding activities, in the regulatory text and in 
guidance. After considering these comments, we revised our proposed 
definition of ``holding'' and have established the revised definition 
in Sec.  1.227, as explained in section IV of the final human 
preventive controls rule (80 FR 55908 at 55933-55934). In that 
document, we discussed in detail our consideration of comments received 
and revisions to our proposed definition of ``holding''.
    Consistent with the definition of ``holding'' in Sec.  1.227, we 
are defining ``holding'' in Sec.  112.3(c) to mean ``storage of food 
and also includes activities performed incidental to storage of a food 
(e.g., activities performed for the safe or effective storage of that 
food, such as fumigating food during storage, and drying/dehydrating 
raw agricultural commodities when the drying/dehydrating does not 
create a distinct commodity (such as drying/dehydrating hay or 
alfalfa)). Holding also includes activities performed as a practical 
necessity for the distribution of that food (such as blending of the 
same raw agricultural commodity and breaking down pallets), but does 
not include activities that transform a raw agricultural commodity into 
a processed food as defined in section 201(gg) of the [FD&C Act]. 
Holding facilities could include warehouses, cold storage facilities, 
storage silos, grain elevators, and liquid storage tanks.''
    Definition of ``packing.'' In the supplemental notice, taking into 
account public comment on our proposed definition of ``packing'' in the 
2013 proposed rule and consistent with our proposed amendments to the 
definition of ``packing'' as it applies to proposed part 117, we 
proposed to amend the definition of ``packing'' in proposed Sec.  
112.3(c).
    We proposed to amend the definition of ``packing'' to mean 
``placing food into a container other than packaging the food and also 
includes activities performed incidental to packing a food (e.g., 
activities performed for the safe or effective packing of that food 
(such as sorting, culling and grading)), but does not include 
activities that transform 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].'' (For reference, we previously proposed to define 
``packaging'' (when used as a verb) to mean placing food into a 
container that directly contacts the food and that the consumer 
receives.)
    In response to the supplemental notice and the supplemental human 
preventive controls notice, some comments asked us to consider 
additional activities within the ``packing'' definition and to clarify 
the distinction between ``packing'' and ``packaging.'' After 
considering these comments, we revised our proposed definition of 
``packing'' and have established the revised definition in Sec.  1.227, 
as explained in section IV of the final human preventive controls rule 
(80 FR 55908 at 55935-55936). In that document, we discussed in detail 
our consideration of comments received and revisions to our proposed 
definition of ``packing''.
    Consistent with the definition of ``packing'' in Sec.  1.227, we 
are defining ``packing'' in Sec.  112.3(c) to mean ``placing food into 
a container other than packaging the food and also includes activities 
performed incidental to packing a food (e.g., activities performed for 
the safe or effective packing of that food (such as sorting, culling, 
grading, and weighing or conveying incidental to packing or re-
packing)), 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.''
    (Comment 81) Some comments ask us to clarify that packaging and 
labeling activities include repackaging and relabeling, and state that 
repackaging or relabeling may be incidental to packaging and labeling 
activities and does not introduce new or different risks to public 
health.
    (Response) We agree that packaging and labeling activities may 
include repackaging and relabeling and do not

[[Page 74399]]

necessarily introduce new or different risks to public health.
2. Additional Definitions
    We are making various revisions to our proposed definitions, as 
discussed in this section (see Table 4). For the following terms, we 
did not receive any comments or received only general comments in 
support of the proposed definition and, therefore, we do not 
specifically discuss them in this section: ``agricultural water,'' 
``application interval,'' ``food-contact surfaces,'' ``manure,'' 
``pest,'' ``pre-consumer vegetative waste,'' ``raw agricultural 
commodity,'' ``sewage sludge biosolids,'' ``spent sprout irrigation 
water,'' ``table waste,'' ``water distribution system,'' and ``we''. We 
are finalizing the definitions of these terms as proposed, except as 
described in Table 4.
    Definitions of ``adequate'' and ``adequately reduce microorganisms 
of public health significance''. We proposed to define ``adequate'' to 
mean that which is needed to accomplish the intended purpose in keeping 
with good public health practice. We also proposed to define 
``adequately reduce microorganisms of public health significance'' to 
mean reduce the presence of such microorganisms to an extent sufficient 
to prevent illness.
    (Comment 82) Some comments state that these proposed definitions 
are not clear and, as proposed, they would not ensure uniformity or 
consistency in safe practices. Comments suggest clarifying the phrase 
``to an extent sufficient to prevent illness'' to refer to ``reducing 
the presence of microorganisms, for example, through cleaning and 
sanitizing using EPA-registered or FDA-regulated antimicrobials for 
food use or through other means such as heat and ozone.''
    (Response) As explained in the 2013 proposed rule, the definition 
of ``adequate'' we are applying in this rule is the same as the long-
standing definition used in relation to current good manufacturing 
practices in manufacturing, packing, or holding human food. We have 
provided clarification for how this term relates to specific 
requirements in part 112 through examples throughout the 2013 proposed 
rule and this final rule. We are finalizing the definition of 
``adequate'' as proposed.
    We finalizing the definition of ``adequately reduce microorganisms 
of public health significance'' as proposed. The extent of minimization 
of pathogens 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 and, therefore, is different for different circumstances. For 
example, as noted in our previous guidances to industry (Ref. 93) (Ref. 
94), 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. In addition, we are not including the 
specific examples requested by the comment, or other examples of 
processes that achieve adequate reduction, within this definition as we 
believe that doing so would be confusing because this is only a 
definition of the term ``adequately reduce the presence of 
microorganisms of public health significance,'' and not a definition of 
commercial processing steps that achieve such reductions. We conclude 
that a better place for examples is in Sec.  112.2(b), the exemption 
for produce that receives commercial processing that adequately reduces 
the presence of microorganisms of public health significance, and we 
have included examples there, including new examples added in this rule 
(see section IX.A.4 of this document). We have not added the specific 
examples identified by the commenter in that section, however, because 
although use of certain antimicrobial substances, heat, or ozone 
treatments may adequately reduce pathogens depending on the 
circumstances, we cannot categorically conclude that they would do so 
under all circumstances.
    Definitions of ``agricultural tea'' and ``agricultural tea 
additive''. We proposed 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. We also proposed 
that agricultural teas are held for longer than one hour before 
application.
    We proposed 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.
    (Comment 83) Some comments ask that we use the term ``compost tea'' 
instead of ``agricultural tea.'' Some comments also asked that we align 
our definitions of ``agricultural tea'' and ``agricultural tea 
additive'' with similar definitions used by the NOP.
    (Response) We believe ``agricultural tea'' is a more appropriate 
term for applicability to part 112 because we intend this definition to 
cover ``teas'' intended for agricultural use and prepared from various 
feedstocks, and not only those extracts prepared from compost. There 
also may be compost teas that are not intended for agricultural use and 
we do not intend to cover those.
    With regard to the request that we align our definition of 
``agricultural tea'' with the definition of ``compost tea'' used by the 
NOP, we note that the NOP does not have a definition of ``compost tea'' 
but the National Organic Standards Board (NOSB) 2006 recommendation has 
a definition of ``compost tea'' (Ref. 95). The NOSB recommendation 
defines ``compost tea'' as ``a water extract of compost produced to 
transfer microbial biomass, fine particulate organic matter, and 
soluble chemical components into an aqueous phase, intending to 
maintain or increase the living, beneficial microorganisms extracted 
from the compost.'' We believe these definitions are sufficiently 
aligned and see no benefit to narrowing the broader scope of FDA's 
definition (including various feedstocks) to cover only teas prepared 
using stabilized compost as a feedstock. Because we are not making 
these changes to the definition of ``agricultural tea'', we do not 
believe it is appropriate to modify our definition of ``agricultural 
tea additive'' (which is based on the definition of ``agricultural 
tea'') to match the NOSB recommended definition of ``compost tea 
additive.'' Because the end product of composting is better described 
as ``stabilized compost'' rather than ``humus,'' we are changing this 
term in the definition of ``agricultural tea.'' We discuss this change 
in additional detail under the definition of ``stabilized compost''. In 
addition, we are adding a sentence to the definition of ``agricultural 
tea'' to specify that ``[a]gricultural teas are soil amendments for the 
purposes of this rule.'' See section XIV of this document for 
discussion of this change.
    Definition of ``animal excreta''. We proposed to define ``animal 
excreta'' to mean solid or liquid animal waste.
    (Comment 84) One comment requests that fish excreta be excluded 
from the definition of ``animal excreta.''
    (Response) All solid or liquid animal waste is considered animal 
excreta, and this includes fish excreta. See also discussion in section 
III.G of this document.
    Definitions of ``biological soil amendment'' and ``biological soil

[[Page 74400]]

amendment of animal origin''. We proposed to define ``biological soil 
amendment'' 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. In 
addition, we proposed 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; and that it 
does not include any form of human waste.
    Because the end product of composting is better described as 
``stabilized compost'' rather than ``humus,'' we are changing this term 
in the definition of ``biological soil amendment.'' We discuss this 
change in additional detail under the definition of ``stabilized 
compost''.
    (Comment 85) Some comments request that we align the definition of 
``biological soil amendment of animal origin'' with that established by 
the American Plant Food Control Officials. Some comments also request 
that the definition clarify whether mortality compost is included.
    (Response) We are not aware that the American Plant Food Control 
Officials have a definition of `biological soil amendment of animal 
origin' and the comments did not provide such a definition for 
consideration. With regard to the question about mortalities as a 
feedstock, animal mortalities or animal mortality compost are materials 
of animal origin that could be used as a component of a biological soil 
amendment of animal origin within the terms of the definition. Since 
the comment requested clarity, we are adding animal mortalities as an 
example in the definition of biological soil amendment of animal 
origin.
    (Comment 86) One comment asks that definitions clearly specify 
``treated'' versus ``untreated'' biological soil amendments, to clarify 
that if one component of the ``treated'' biological soil amendment is 
untreated, then the entirety of the biological soil amendment should be 
considered ``untreated.''
    (Response) Section 112.51 establishes the requirements for 
determining a biological soil amendment as treated (Sec.  112.51(a)) or 
untreated (Sec.  112.51(b)), and we do not think it is necessary to 
incorporate these concepts in the definition of biological soil 
amendment, or biological soil amendment of animal origin. Under Sec.  
112.51(b), a biological soil amendment is untreated if, among other 
conditions, the biological soil amendment has become contaminated after 
treatment; has been recombined with an untreated biological soil 
amendment of animal origin; or 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. Under 
these provisions, if the biological soil amendment of animal origin 
contains a component that is an untreated biological soil amendment of 
animal origin, or it 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 a foodborne illness, the entire biological soil 
amendment of animal origin is considered untreated.
    Definition of ``composting''. We proposed 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 [deg]F (55 [deg]C)), followed 
by a curing stage under cooler conditions.
    (Comment 87) Some comments state this proposed definition does not 
sufficiently address the biological degradation and transformation of 
organic solid waste that has been subjected to controlled aerobic 
degradation at a solid waste facility in compliance with relevant 
requirements. Some comments also disagree that the process produces 
``humus.'' In addition, some comments note that the proposed definition 
does not encompass various processes that can be used to create safe, 
usable, and mature compost. For example, commenters point to mixing of 
organic waste with bulking agents, volatile organic compounds, heat, or 
water, and state that composting can occur under both thermophilic and 
mesophilic conditions, but is not always followed by curing. Some 
comments suggest establishing performance standards rather than 
establishing a definition for composting.
    (Response) We have revised Sec.  112.54 to indicate that 
``composting'' is only one type of biological process that may meet the 
requirements in that section and Sec.  112.55(a) and (b) (see section 
XIV of this document). However, we also continue to believe that the 
process of composting involves a time and temperature treatment, 
followed by curing. We agree that the end product of composting is 
better described as ``stabilized compost'' rather than ``humus'' and 
have made this change both here and in the proposed definition of 
``humus,'' which we are now finalizing as a definition of the term 
``stabilized compost'' and which we discuss in detail under the 
definition of ``stabilized compost''.
    Definition of ``covered activity''. In the supplemental notice, we 
proposed to amend the definition of ``covered activity'' to mean 
``growing, harvesting, packing, or holding covered produce on a farm, 
and that ``covered activity'' includes manufacturing/processing of 
covered produce on a farm, but only to the extent that such activities 
are performed on RACs and only to the extent that such activities are 
within the meaning of ``farm'' as defined in this chapter. We also 
noted that part 112 does not apply to activities of a facility that are 
subject to 21 CFR part 110.
    (Comment 88) Some comments support the coordinated revisions to the 
definitions of covered activity, harvesting, holding, and packing to 
support the broader definition of farm, while others request FDA to 
provide additional clarity by adding specific examples to the 
definition of ``covered activity.''
    (Response) We do not see the need for additional examples in the 
definition of ``covered activity.'' Throughout the discussion of the 
definitions of farm, harvesting, packing, and holding, both here and in 
the final human preventive controls rule, we believe we have provided 
sufficient examples to help covered farms understand whether an 
activity is a covered activity subject to part 112 (see 80 FR 55908 at 
55925-55932), and we will consider issuing guidance on these issues as 
appropriate.
    We are revising the definition of ``covered activity'' to reflect 
new Sec.  112.2(b)(6) (see section IX.A.4 of this document). We are 
adding a statement to this definition to make clear that providing, 
acting consistently with, and documenting actions taken in compliance 
with written assurances as described in Sec.  112.2(b) of this part are 
also covered activities.
    Definition of ``covered produce''. We proposed 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.
    (Comment 89) Some comments suggest stating, within the definition 
of ``covered produce,'' that circumstances where contamination of crops 
during early stages of production does not pose a public health risk 
would not be covered under this rule. Other commenters request 
inclusion of a

[[Page 74401]]

statement that ``covered produce'' includes only the harvested portion 
of the plant.
    (Response) Covered produce is produce that is subject to part 112 
as provided in Sec. Sec.  112.1 and 112.2, and our proposed definition 
already specified that this term refers to the harvested or harvestable 
portion of the crop. For the purposes of determining which produce 
should be subject to part 112, it would not be appropriate to exempt 
some produce based on the point in time at which contamination may 
occur. The fact that contamination may occur during the early stages of 
production does not, in and of itself, provide a reasonable assurance 
of lack of potential contamination at a later point in the growing, 
harvesting, packing, or holding of that produce. Note also, under Sec.  
112.2(a), we have exempted certain produce because it is rarely 
consumed raw, and in Sec.  112.2(b), we have provided for produce to be 
eligible for exemption from the requirements of this rule if it 
receives commercial processing that adequately reduces the presence of 
microorganisms of public health significance.
    (Comment 90) Some comments suggest referring to produce covered 
under this rule as ``fresh produce'' rather than as ``covered 
produce.''
    (Response) The term ``fresh produce'' would not convey the meaning 
we intend to convey with the term ``covered produce.'' We use ``covered 
produce'' to describe produce that is within the scope of the rule 
under Sec.  112.1 and not exempt from the rule under Sec.  112.2. Not 
all ``fresh produce'' commodities fall within the scope of this rule. 
For example, although produce that is rarely consumed raw, for example, 
asparagus, may be viewed as ``fresh produce'' when they are presented 
to the consumer in their raw, natural, and unprocessed state, such 
commodities are not ``covered produce'' because they are exempt from 
this rule under the provisions of Sec.  112.2(a)(1). The term ``covered 
produce'' helps us to distinguish the subset of ``produce'' (as defined 
herein) that falls within the scope of this rule. The term ``fresh 
produce'' is not an acceptable substitute.
    Definition of ``curing''. We proposed 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.
    (Comment 91) Some comments suggest defining ``curing'' as the final 
stage of the composting process rather than the maturation stage, and 
that adequate curing would be achieved when a state of ``stable'' or 
``very stable'' is reached.
    (Response) We agree that ``curing'' may be more accurately 
described as the ``final'' stage of the composting process, so we are 
making this change. We have also replaced the term ``humus'' in the 
related definition of ``composting'' with ``stabilized compost,'' which 
captures the fact that the end product of the composting process is a 
stabilized product.
    Definition of ``direct water application method''. We proposed 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. We also noted in the preamble of the 2013 proposed rule, by 
cross-reference to the definitions of ``covered produce'' and 
``produce'', this term would only apply to methods in which the water 
is intended to, or is likely to, contact the harvestable part of the 
covered produce.
    (Comment 92) Some commenters believe direct water application 
methods should include postharvest water application, but not drip or 
trickle irrigation of root crops.
    (Response) We have defined direct water application methods in 
terms of the intent or likelihood of contact as opposed to specific 
irrigation practices because it is contact of the agricultural water 
with the harvestable portion of the covered commodity that could result 
in contamination of the covered crop if the water is not appropriately 
managed. With respect to root crops, the analysis is the same. A water 
application method is a direct water application method if it is 
intended to, or is likely to, contact covered produce or food-contact 
surfaces during use of the water. For example, irrigating carrots using 
drip irrigation that is intended to filter through the soil and contact 
the carrots growing underground is a direct water application method 
because the water is intended to, and likely to, contact the covered 
produce.
    Definition of ``food''. We proposed to define food to mean food as 
defined in section 201(f) of the Federal Food, Drug, and Cosmetic Act 
and includes seeds and beans used to grow sprouts.
    (Comment 93) One comment requests that we definitively indicate 
that the seeds and sprouts included in the definition for food (as 
defined in section 201(f) of FD&C Act) are those for human consumption 
and to differentiate such seeds and sprouts from those grown for 
planting or transplanting.
    (Response) For the purposes of the produce safety regulation, in 
Sec.  112.3, we define ``food'' to mean food as that term is defined in 
section 201(f) of the FD&C Act, and we explicitly include seeds and 
beans used to grow sprouts in this definition for clarity because 
sprouts are covered by this rule. Food is defined in section 201(f) of 
the FD&C Act, in part, as articles used as food or drink for man or 
other animals, and articles used for components of any such article. 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. 
96). Seeds and beans used to grow sprouts are both articles used as 
food as well as articles used as components of articles used as food.
    As defined, the terms ``produce'' and ``covered produce'' for the 
purposes of part 112 refer to the harvestable or harvested part of a 
crop. When seeds and/or sprouts are the harvestable or harvested part 
of a crop, they may be covered produce for purposes of this rule if 
they fall within the definition of produce and are not otherwise 
exempt. On the other hand, when seeds or sprouts are not part of the 
harvestable or harvested part of a crop, they are not covered produce 
for purposes of this rule.
    Definition of ``ground water''. As discussed under Comment 232, we 
are adding a definition for the term ``ground water,'' and making 
corresponding revisions to the term ``surface water'' to clarify the 
differences between the two sources of water.
    Definition of ``hazard''. We proposed to define ``hazard'' to mean 
any biological agent that is reasonably likely to cause illness or 
injury in the absence of its control.
    (Comment 94) Comments express a view that the terms ``reasonably'' 
and ``likely'' used in this proposed definition are ambiguous, and 
request clarification.
    (Response) We are revising the definition by replacing the phrase 
``that is reasonably likely to cause illness or injury'' with ``that 
has the potential to cause illness or injury'' to more clearly 
distinguish ``hazard'' from ``known or reasonably foreseeable hazard.'' 
This increases the alignment of the definition of ``hazard'' in this 
rule with the Codex definition of ``hazard'' and the definition of 
``hazard'' in the PCHF regulation.
    Definition of ``microorganisms''. We proposed to define 
``microorganisms'' to mean yeasts, molds, bacteria, viruses, protozoa, 
and microscopic parasites and

[[Page 74402]]

to include species having public health significance. We also proposed 
that 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.
    (Comment 95) One comment suggests that ``microorganisms'' should 
include non-bacterial agents of disease. Another comment believes that 
the term ``undesirable microorganisms'' should not include those that 
subject food to decomposition.
    (Response) As discussed in section VI of this document, we focus 
the produce safety standards established under part 112 on biological 
hazards only. The biological hazards that are addressed through this 
regulation include bacteria, parasites, and viruses. With respect to 
the comment about ``undesirable microorganisms,'' we are retaining this 
term and its inclusion of microorganisms that subject food to 
decomposition because such decomposition microorganisms may also be 
undesirable for food safety or produce substances (for example, 
mycotoxins) that are undesirable for food safety. We believe it is 
appropriate to include microorganisms that subject food to 
decomposition to generally define microorganisms, although the 
standards in part 112 are not targeted at addressing undesirable 
microorganisms but at addressing microorganisms of public health 
concern (i.e., pathogens).
    Definition of ``mixed-type facility''. We proposed 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. 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.
    (Comment 96) Some comments argue that Congress included provisions 
in both sections 418 and 419 of the FD&C Act to ensure an appropriate, 
coordinated, and targeted regulatory framework, with the intent that 
one operation would not be subject to multiple sets of regulations 
under FSMA, and that farms would continue to be exempt from the 
facility registration requirement. These comments ask FDA to adhere to 
congressional intent in defining ``farm mixed-type facility'' and to 
apply a broad reading of the term farm and a narrow reading of the term 
facility.
    (Response) We are revising the definition of ``mixed-type 
facility,'' consistent with the definition of this term in part 117, to 
mean an establishment that engages in both activities that are exempt 
from registration under section 415 of the FD&C 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 is a farm, but that also conducts activities 
outside the farm definition that require the establishment to be 
registered.
    Whether a particular establishment that falls within the definition 
of ``mixed-type facility'' is subject to the requirements for hazard 
analysis and risk-based preventive controls of part 117 is governed by 
the exemptions established in Sec.  117.5. The definitions of ``farm,'' 
``harvesting,'' ``packing,'' and ``holding,'' too, reflect our careful 
consideration of the different types of activities that occur on-farm, 
off-farm, or on farm mixed-type facilities. We have been careful to 
establish that the activities of a farm mixed-type facility that fall 
within the farm definition are subject to the produce safety regulation 
and activities falling outside the farm definition are potentially 
subject to the PCHF regulation; we do not subject the same activity to 
duplicative requirements under both rules. In the revisions we have 
made to the ``farm'' definition we have made an attempt to interpret 
the activities that may occur on a farm very broadly, with a consequent 
reduction in certain activities that would be subject to part 117. See 
the final human preventive controls rule and the supplemental human 
preventive controls notice for discussion of related issues.
    Definition of ``monitor''. We proposed 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.
    (Comment 97) Some comments suggest that the use of the phrase 
``when applicable'' in this definition should be replaced with ``when 
required.''
    (Response) We agree with this suggestion, and we are making this 
change.
    Definition of ``non-fecal animal byproduct''. We proposed to define 
``non-fecal animal byproduct'' to mean 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.
    (Comment 98) Some comments support this proposed definition, 
although a few suggest making it clear that wastes generated by other 
operations, including fish waste, are included within this definition.
    (Response) We are revising this definition to replace the phrase 
``other than excreta'' with ``other than manure.'' Under this 
definition, solid wastes that do not fall within the definition of 
``manure'' and that are generated by fish operations, such as fish meal 
and fish emulsions, are considered non-fecal animal byproduct. On the 
other hand, fish excreta is animal excreta. See discussion in section 
III.G of this document regarding aquaculture operations.
    Definition of ``packaging (when used as a verb)''. We proposed to 
define ``packaging (when used as a verb)'' to mean placing food into a 
container that directly contacts the food and that the consumer 
receives.
    (Comment 99) Some comments express concern about establishing the 
definition of ``packaging (when used as a verb)'' in part 112. These 
comments ask us to clarify how this proposed definition relates to 
other uses of the word ``packaging'' in part 112, including use as an 
adjective in the common phrase ``food-packaging materials''. Some 
comments focus on the differences between the definition of the term 
``packing'' and ``packaging'' with respect to activities conducted on 
RACs. Some comments ask us to clarify how the term ``packaging (when 
used as a noun)'' would apply when used in part 112, even though we did 
not propose to establish a definition for ``packaging (when used as a 
noun)'' in part 112.
    (Response) We have decided not to establish the definition 
``packaging (when used as a verb)'' in part 112. That definition was 
established in the section 415 registration regulations and the section 
414 recordkeeping regulations, in part, to identify those food 
establishments that would be subject to those regulations. In addition, 
the section 414 recordkeeping regulations established a definition of 
``packaging (when used as a noun)'' because it was also necessary for 
the purposes of those recordkeeping regulations. However, the term 
``packaging'' has long been used in our existing Current Good 
Manufacturing Practice in Manufacturing, Packing or Holding Human Food 
regulation (current 21 CFR part 110; ``the Food CGMP regulation'')

[[Page 74403]]

to generally refer to the container that directly contacts the food, 
rather than to the outer packaging of food that does not contact the 
food (as it means in the section 414 recordkeeping regulations). Thus, 
the very specific connotation for the term ``packaging (when used as a 
noun)'' that was established in the section 415 registration 
regulations and the section 414 recordkeeping regulations does not 
apply, and is causing confusion. As the comments point out, our 
proposed definition is already causing confusion in the context of part 
112. Therefore, for clarity and simplicity in part 112 we are not 
including in the final rule a definition of ``packaging (when used as a 
verb).'' This deletion is consistent with our decision to not establish 
such a definition in part 117. The definition of ``manufacturing/
processing'' we are establishing in this rule makes clear that 
``packaging'' (when used as a verb) is a manufacturing/processing 
activity. The comments that express confusion about the distinction 
between ``packing'' and ``packaging (when used as a verb)'' with 
respect to activities conducted on RACs no longer apply in light of the 
revised ``farm'' definition. The revised ``farm'' definition provides 
for packaging RACs when packaging does not involve additional 
manufacturing/processing (such as cutting).
    Definition of ``production batch of sprouts''. We proposed 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).
    (Comment 100) Some comments note that various types and sizes of 
growing units are typically used by sprout operations, and the proposed 
definition would have varying impacts on sprouting operations based on 
their equipment type and capacity. Some comments state this proposed 
definition would disproportionately impact small sprout operations, 
which tend to germinate smaller batches of seed, because the sampling 
and testing requirements that relate to this definition are specific to 
each production batch, regardless of the amount of seed in each batch.
    (Response) Our definition is intended to treat product that is 
exposed to the same conditions during sprouting as one production 
batch, and we are finalizing it as proposed. This definition is 
consistent with our 1999 guidance for industry on sampling and 
microbial testing of spent irrigation water during sprout production 
(Ref. 97). We recognize there is a diversity of growing practices and a 
variety of growing units that may represent different product volumes 
and, therefore, production batches can vary greatly in size. However, 
as noted in the 2013 proposed rule, we are limiting the definition of 
``production batch of sprouts'' to a single growing unit to prevent 
``pooling'' of 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, increasing the point that 
pathogens might not be detected. We discuss the related sampling and 
testing requirements of subpart M in section XVIII of this document.
    (Comment 101) Some comments ask us to establish definitions for the 
terms ``batch,'' ``sprouts,'' and ``soil-grown sprouts.''
    (Response) We define ``production batch of sprouts'' in Sec.  112.3 
and do not see a reason to also provide an additional definition of 
``batch'' in relation to sprouts. The requirements in subpart M of this 
rule relate to production batches of sprouts, making this the relevant 
term to define in this rule. We have added a new section, Sec.  
112.141, to clarify the types of commodities that are subject to the 
requirements of subpart M of part 112. See section XVIII of this 
document. With this addition, we conclude it is sufficiently clear what 
commodities are subject to subpart M and we need not also establish a 
definition of ``sprouts'' or ``soil-grown sprouts'' for this purpose.
    Definition of ``qualified end-user''. We proposed 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 (1) in the same State as 
the farm that produced the food; or (2) not more than 275 miles from 
such farm. We proposed that the definition would also state that the 
term ``consumer'' does not include a business.
    We are editing this definition to move the phrase ``The term 
`consumer' does not include a business'' from out of paragraph (ii) and 
into a parenthetical phrase within the definition of ``qualified end-
user'' because the term ``consumer'' is used in the definition of 
``qualified end-user'' and not in paragraph (ii). We are also adding 
``or the same Indian reservation'' to the definition of ``qualified 
end-user'' to clarify for purposes of this rule that ``in the same 
state'' under 21 U.S.C. 350h(f)(4)(A)(ii)(II) includes both within a 
State and within the reservation of a Federally-recognized tribe.
    (Comment 102) Some comments argue that Congress only intended the 
275 mile distance criterion in the definition of ``qualified end-user'' 
to be applied within the United States, its territories, and the 
Commonwealth of Puerto Rico. On the other hand, other comments asked 
FDA to clarify that the 275 mile criterion also applies within foreign 
countries, such that there is an equitable treatment of domestic and 
foreign farms.
    (Response) The definition of ``qualified end-user'' in Sec.  
112.3(c) implements section 419(f)(4) of the FD&C Act. 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 and, 
therefore, we proposed that international borders would not affect the 
distance calculation. We are not aware of any basis from which to 
conclude that Congress intended the distance criterion to be limited to 
domestic application, or to be otherwise affected by international 
borders, and the comments did not provide any information from which we 
might draw such a conclusion. We see no reason to treat sales to 
restaurant and retail food establishment buyers within 275 miles of a 
farm differently based on the presence of an international border for 
the limited purpose of calculating which of a farm's sales are to 
qualified end-users. We note that some of the commenters seem to 
confuse criteria for which sales may be counted as sales to qualified 
end-users with criteria for exemption from the rule. Sales to qualified 
end-users, in and of themselves, do not amount to exemptions from the 
rule. A farm must meet all the criteria provided in Sec.  112.5(a) to 
be eligible for the qualified exemption. These criteria in Sec.  
112.5(a) are based only in part on sales to qualified end-users. For 
all of these reasons, we conclude that international borders do not 
affect the 275 mile distance calculation in the definition of qualified 
end-user. Therefore, for example, a farm in Mexico or Chile selling 
food to a restaurant or retail food establishment that is located in a 
neighboring country (for example, the United States and Argentina, 
respectively) that is within 275 miles of the farm would be able to 
count that sale as a sale to a qualified end-user. The same would also 
be true for United States farms that sell food to a restaurant or 
retail food establishment in a neighboring country that is within 275 
miles of the farm. In short, a farm in any country can be eligible for 
a qualified

[[Page 74404]]

exemption, provided it meets the criteria established in Sec.  
112.5(a).
    (Comment 103) Several comments ask FDA to clarify what would be 
considered a sale ``directly to consumers'' for purposes of the 
definition of ``retail food establishment'' in Sec.  1.227(b)(11), 
which is used in the definition of ``qualified end-user'' in Sec.  
112.3(c). Some comments ask us to revise the definition of ``restaurant 
or retail food establishment'' to include enterprises such as 
supermarkets, supermarket distribution centers, food hubs, farm stands, 
farmers markets, and CSA.
    (Response) FDA is addressing the definition of ``retail food 
establishment'' in a separate rulemaking. In a recent notice of 
proposed rulemaking titled, ``Amendments to Registration of Food 
Facilities'' (80 FR 19160; April 9, 2015), FDA proposed various 
amendments, including to the definition of ``retail food 
establishment'' in Sec.  1.227(b)(11).
    (Comment 104) Some comments suggest sales to qualified end-users 
should include internet or mail-order sales. Some comments suggest 
sales that they term ``secondary'' should be considered sales to 
qualified end-users. These commenters provide the example of dairy 
farmers who grow produce for what they consider to be ``ancillary'' or 
``incidental'' sales.
    (Response) The definition of ``qualified end-user'' implements 
section 419(f)(4) of the FD&C Act. A sale conducted online or through 
mail-order can be considered a sale to a qualified end-user if the 
buyer meets the definition of a qualified end-user. We note that the 
definition of ``qualified end-user'' includes the consumer of the food, 
without regard to that consumer's location relative to the farm. We are 
not aware of any basis from which to conclude that Congress intended 
that what one commenter describes as ``secondary'' sales should be 
considered sales to qualified end-users on the basis of the farm's 
impression that such sales are only ancillary or incidental to their 
business. Moreover, we note that for the purposes of determining 
eligibility for a qualified exemption under Sec.  112.5, sales to a 
qualified end-user are calculated based on the sale of all ``food,'' 
and not on sales of ``produce'' only.
    Definition of ``known or reasonably foreseeable hazard'' (proposed 
``reasonably foreseeable hazard''). We proposed to define ``reasonably 
foreseeable hazard'' to mean a potential hazard that may be associated 
with the farm or the food.
    (Comment 105) Some commenters ask for clarification of the proposed 
definition, and express concern that it is not sufficiently clear to 
ensure uniformity and consistency in safe practices. One commenter 
suggests including the word ``biological'' within this proposed 
definition, consistent with the proposed definition of ``hazard''.
    (Response) We are making revisions to define the term ``known or 
reasonably foreseeable hazard'' to mean ``a hazard that is known to be, 
or has the potential to be, associated with the farm or the food'' to 
better align with definition of the same term in the PCHF regulation. 
This term is used in section 419(c)(1)(A) of the FD&C Act, and is 
reflected in several requirements in part 112. We have provided 
clarification for how this term relates to specific requirements in 
part 112 through examples throughout this final rule. In addition, by 
cross-reference to the definition of ``hazard,'' a ``known or 
reasonably foreseeable hazard'' as defined for the purposes of part 112 
is limited to biological hazards because those are the only hazards we 
are addressing in this rule. For clarity, we are adding the term 
``biological'' to the definition of ``known or reasonably foreseeable 
hazard.''
    Definition of ``sanitize''. We proposed 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.
    We are retaining this definition with one change. In the PCHF 
regulation, we defined ``sanitize'' to mean ``to adequately treat 
cleaned 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.'' We are making a corresponding revision to the definition of 
``sanitize'' as it applies to part 112 by referring to adequately 
treating ``surfaces'' rather than ``food-contact surfaces.'' Adequately 
treating any cleaned surface--regardless of whether it is a food-
contact surface--by a process that is effective in destroying 
vegetative cells of pathogens, and in substantially reducing numbers of 
other undesirable microorganisms, but without adversely affecting the 
product or its safety for the consumer, is ``sanitizing'' the surface. 
This change to clarify the definition of ``sanitize'' does not affect 
the requirements to sanitize, when applicable, which are established 
throughout part 112.
    Definition of ``stabilized compost'' (proposed ``humus''). We 
proposed to define ``humus'' to mean a stabilized (i.e., finished) 
biological soil amendment produced through a controlled composting 
process.
    (Comment 106) Several comments disagree with our proposed use of 
the term ``humus'' (see also discussion of definition of 
``composting''). These commenters state that the term ``humus,'' as 
proposed, would be better described by reference to the static state of 
compost at the end of the composting process. These commenters note 
that the organic material at the end of the composting process is 
beyond the active stage, with reduced biological activity marked by 
reduced temperature and respiration rate. These commenters further 
explain that composting requires specific time and temperature 
conditions to achieve controlled biological decompositions and 
stabilization of organic material, and that it is in this stabilized 
state that the material is useful and beneficial to plant growth. Thus, 
these commenters argue that the biologically stable material that is 
derived from the composting process should be referred to as 
``compost'' rather than ``humus.'' These commenters explain that humus 
forms naturally (in forests and other landscapes) as a component of 
soils, and may be only one component of finished or mature compost and 
should not be used to refer to ``compost'' as a whole. One comment 
asked that we align the definition of ``humus'' (compost) with the NOP 
definition of ``compost''.
    (Response) We agree the term ``stabilized compost'' is a better 
representation of the finished product of composting. We are revising 
the codified to use the term ``stabilized compost'' rather than 
``humus'' everywhere it appears, and we are replacing the defined term 
``humus'' with the defined term ``stabilized compost'' (with the same 
defined meaning). This change affects the definitions of ``agricultural 
tea,'' ``biological soil amendment,'' ``composting,'' ``growth media,'' 
``soil amendment,'' ``static composting,'' and ``turned composting.'' 
We do not believe it is necessary to align our revised definition of 
``stabilized compost'' with the NOP definition of ``compost'' in 7 CFR 
part 205. The NOP definition of ``compost'' includes a great deal of 
detail about the process of composting which we do not believe is 
necessary for our use of the term ``stabilized compost'' in part 112 
and also could be viewed as limiting the mechanisms by which

[[Page 74405]]

compost can be made, which is not our intent.
    Definition of ``static composting,'' We proposed 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. We further proposed to state 
that examples of structural features for introducing air include 
embedded perforated pipes and a constructed permanent base that 
includes aeration slots, and that examples of mechanisms for 
introducing air include passive diffusion and mechanical means (such as 
blowers that suction air from the composting materials or blow air into 
the composting material using positive pressure).
    (Comment 107) Arguing that the definition should exclude passively 
aerated systems, some commenters recommend using the term ``aerated 
static composting'' to ensure proper treatment to achieve time and 
temperature conditions.
    (Response) We disagree that the definition of ``static composting'' 
should exclude passively aerated systems. In fact, we indicate in the 
definition that passive diffusion is one method for introducing air to 
the composting material. Therefore, we decline to change the definition 
to ``aerated static composting.'' We recognize that composting that 
includes passively aerated systems may have cold spots due to uneven 
aeration; however, it is not our intent to narrowly limit the way 
compost is produced as long as the stabilized compost meets the 
standards of Sec.  112.54(a) or (b).
    As discussed previously, we are replacing the term ``humus'' with 
``stabilized compost'' in the definition of ``static composting.'' We 
are also making a change to indicate that static composting may or may 
not involve the use of insulating material. The revised definition of 
``static composting'' reads ``static composting means a process to 
produce stabilized compost in which air is introduced into biological 
material (in a pile (or row) that may or may not be covered with 
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 materials or blow air into the 
composting material using positive pressure).''
    Definition of ``yard trimmings.'' We proposed 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.
    (Comment 108) We received mixed comments on the use of terms ``yard 
trimmings,'' ``yard trash,'' and ``yard debris''. Some commenters 
suggest using the term ``yard debris'' to refer to plant material 
commonly created in the course of yard and garden maintenance through 
horticulture, gardening, brush, weeds, flowers, roots, windfall fruit, 
and vegetable garden debris. Some comments note that yard trimmings and 
pre-consumer vegetative waste could contain arthropods or dog waste, 
and suggest using a term that would be more restrictive so as to avoid 
such potential inclusions, such as ``vegetation trimmings,'' 
``vegetable debris,'' ``foliage,'' ``excess flora,'' or ``plants, 
bushes and tree parts.'' Other comments recommend defining a new 
category of vegetative waste, referred to as ``wood waste,'' to include 
materials such as wood pieces or particles generated as byproducts from 
the manufacturing of wood products, construction, demolition, handling 
and storage of raw materials, trees and stumps, sawdust, chips, 
shavings, bark, pulp, hogged fuel, and log sort yard waste. These 
commenters note that wood waste does not include wood pieces containing 
paint, laminates, bonding agents, or chemical preservatives.
    (Response) We are retaining the term ``yard trimmings'' to refer to 
purely vegetative matter resulting from landscaping maintenance or land 
clearing operations. Commenters were split on whether we should use 
this term or an alternate term such as ``yard debris,'' ``vegetation 
trimmings,'' or ``wood waste'' to express the same meaning, and no 
comment provided a reason to think ``yard trimmings'' would be 
confusing or problematic. The materials commenters listed as yard 
debris, vegetation trimmings, or wood waste are encompassed within our 
definition of ``yard trimmings.'' We use the term ``yard trimmings'' to 
avoid potentially negative connotations associated with the word 
``trash,'' even though some components of our definition (e.g., 
untreated wooden pallets) arguably are not ``trimmings.'' Dog droppings 
and other animal wastes are not yard trimmings. However, we recognize 
that even in purely vegetative material such as that described in the 
definition of ``yard trimmings,'' there is the potential for unknown 
and unavoidable contamination with animal waste. We have concluded that 
the likelihood of contaminating produce with pathogens by use of 
biological soil amendments that are not known to contain, and not 
likely to contain significant animal waste or human waste (e.g., yard 
trimmings, pre-consumer vegetative waste) is low, and therefore they 
are not subject to the requirements of this rule. We decline to define 
the term ``yard trimmings'' in a way that makes such materials subject 
to the requirements in this rule.
    Definition of ``you.'' We proposed to define ``you'' to mean a 
person who is subject to some or all of the requirements in this part.
    (Comment 109) Some comments ask that we revise this proposed 
definition to directly link it to the owner or operator in charge of 
the covered farm. One comment also states the person responsible for 
compliance with the produce rule is not necessarily the owner of the 
farmland, but could sometimes be the owner of the business or the 
person with effective operational control over the farm business, such 
as owners, tenants, partners, or employees.
    (Response) We are revising this definition to state that ``you,'' 
for the purposes of part 112, means the owner, operator, or agent in 
charge of a covered farm that is subject to some or all of the 
requirements of part 112. We are also making corresponding edits to the 
questions and provisions in Sec. Sec.  112.4, 112.5, 112.6, and 112.7 
to reflect this revision. Specifically these edits include replacing 
the term ``you'' or ``I'' with ``farm(s).''
3. Other Comments
    (Comment 110) Some comments state that terms such as ``minimize,'' 
``periodic,'' ``regular,'' and ``when necessary and appropriate'' as 
used within the proposed provisions have no clear definitions, and 
suggest that these terms should be defined.
    (Response) As explained in the 2013 proposed rule (see section IV.D 
of that document; 78 FR 3504 at 3529-3521), we developed the regulatory 
framework for this rule taking into account the need to tailor the 
requirements to specific on-farm routes of contamination. We have 
incorporated flexibility into our requirements, wherever appropriate, 
relying on an integrated approach that employs various mechanisms. In 
some cases, the produce safety standards in part 112 are very similar 
to those contained in the

[[Page 74406]]

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 
of the diversity of the industry with respect to size, agricultural 
practices, and knowledge of food safety. Such standards are intended to 
be flexible and inherently necessitate the use of terms such as 
``periodic,'' ``when necessary,'' and ``when appropriate.'' While we 
believe these terms are generally understood, we have provided examples 
throughout the rule to help covered farms better understand the 
requirements.
    (Comment 111) Some comments request that we define the term 
``crop'' to mean both edible and inedible cultivated plants. These 
commenters state that such a definition is necessary to avoid confusion 
in instances where edible portions of a plant come into contact with 
harvested but inedible portions of the plant that may be used, for 
example, in the production of biofuels, clothing, and bio-degradable 
household products.
    (Response) The science-based minimum standards that we are 
establishing in part 112 apply to the growing, harvesting, packing, and 
holding of produce for human consumption. Produce that is not 
reasonably expected to be directed to a food use (for example, produce 
that is reasonably expected to be used in the production of biofuels, 
clothing, or household products) is not subject to the requirements of 
part 112. Therefore, we do not agree that we should establish a 
definition for the term ``crop'' as suggested by these commenters.
    (Comment 112) Some comments request that we provide clear 
definitions for the terms ``greenhouse,'' ``germination chamber,'' and 
``other protected environment production areas.'' Some commenters 
request that FDA define the term ``greenhouse'' using the following 
statement in a Federal Register document issued by the International 
Trade Administration, Department of Commerce: ``Controlled environment 
tomatoes are limited to those tomatoes grown in a fully-enclosed 
permanent aluminum or fixed steel structure clad in glass, impermeable 
plastic, or polycarbonate using automated irrigation and climate 
control, including heating and ventilation capabilities, in an 
artificial medium using hydroponic methods'' (78 FR 14967 at 14970).
    (Response) None of these terms is used to describe any requirements 
in part 112, including in subpart L of 112, and, therefore, their 
inclusion in the list of definitions in Sec.  112.3 is not necessary. 
We respond to comments about the applicability of subpart L to such 
buildings in section XVII of this document.
    (Comment 113) Some comments ask that we establish a definition of 
the term ``standard.''
    (Response) As required by section 419 of the FD&C Act, we have 
established science-based minimum standards for the safe production and 
harvesting of produce in part 112, and we have included definitions 
that are relevant to those standards. We do not see the need to further 
establish a definition for the term ``standard.'' In addition, FDA has 
established many standards related to food safety and we believe this 
term is generally understood by the regulated community.
    (Comment 114) Some comments request that we define the term 
``visitor,'' and suggest that such definition should exclude visitors 
who visit the farm, but do not come into contact with produce or any 
other RAC being produced on the farm.
    (Response) We stated in proposed Sec.  112.33(a) that a visitor is 
any person (other than personnel) who enters your covered farm with 
your permission. We do not expect all visitors to present a reasonable 
likelihood of introducing hazards into covered produce. However, we 
decline to limit the requirements in this rule related to visitors to 
only those visitors who come into contact with produce or other RACs. 
See discussion under Comment 172. We do agree, however, that the 
definition of ``visitor'' that appeared in proposed Sec.  112.33(a) 
should instead appear in Sec.  112.3 with the other definitions, and we 
are making this change to Sec.  112.3 and eliminating proposed Sec.  
112.33(a).
    (Comment 115) Some comments request definitions for other terms 
related to biological soil amendments, including for the terms 
``aging,'' ``feedstock,'' ``green waste,'' and ``maturity.''
    (Response) None of these terms is used to describe the requirements 
in part 112, including in subpart F of part 112, and, therefore, their 
inclusion in the list of definitions in Sec.  112.3 is not necessary.

C. Small Businesses, Very Small Businesses, and Farms That Are Not 
Covered or Are Eligible for a Qualified Exemption

    In the 2013 proposed rule, under proposed Sec.  112.3(b), we 
proposed to establish the definitions for very small business and small 
business, and under proposed Sec.  112.4, we proposed to apply part 112 
only to farms above a certain specified average monetary value of sales 
(78 FR 3504 at 3549). We also proposed Sec. Sec.  112.5 and 112.6 to 
establish the eligibility criteria and modified requirements related to 
farms with a qualified exemption. In addition, in the supplemental 
notice, taking into account public comment, we proposed to amend the 
originally proposed definitions of very small business and small 
business in Sec.  112.3(b) as well as the provision in Sec.  112.4 
regarding farms not covered under this rule (79 FR 58434 at 58436-
58438). In both the 2013 proposed rule and in the supplemental notice, 
we asked for public comment on our proposed provisions.
    We are finalizing Sec. Sec.  112.4, 112.5, and 112.6 with changes, 
and adding new Sec.  112.7, as discussed in this section (see Table 4). 
In this section, we also discuss comments we received in response to 
the 2013 proposed rule, but that we did not address in the supplemental 
notice. We also discuss comments that we received on the amended 
proposed provisions in the supplemental notice.
1. Suggestions Related to Farms Not Covered or Eligible for a Qualified 
Exemption
    (Comment 116) Some comments suggest that farms not covered by this 
rule based on their size, or farms that are eligible for a qualified 
exemption from this rule should be regulated under scale-appropriate 
State-run food safety programs. Some comments also request that FDA 
provide support for States to implement such programs.
    (Response) FDA is not requiring States to set up food safety 
programs for farms eligible for the qualified exemption, nor are we 
prohibiting States from establishing such programs. We do intend to 
continue to work collaboratively with our State and other partners in 
facilitating compliance with this rule. Such efforts will be 
appropriately focused on covered farms, not on farms eligible for the 
qualified exemption. However, we do anticipate that some of the 
materials and programs generated in that effort are likely to be 
helpful to farms eligible for the qualified exemption as well as to 
covered farms. Our existing guidance documents, such as the GAPs Guide, 
provide relevant

[[Page 74407]]

recommendations. In addition, we expect that the training materials 
being developed by the PSA and SSA will be useful resources, including 
for training farms eligible for the qualified exemption in safe produce 
growing, harvesting, packing, and holding practices.
    (Comment 117) One comment recommends that farms not covered by this 
rule based on their size or eligible for a qualified exemption should 
not be allowed to supply produce to entities such as schools or 
hospitals.
    (Response) We do not agree that farms not subject to coverage under 
part 112, or eligible for a qualified exemption should be precluded 
from marketing their produce to schools or hospitals. Produce marketed 
in the United States must be safe for consumption, regardless of 
whether the farm that grew the produce is required to comply with part 
112. There is no reason to believe that produce is unsafe or otherwise 
unfit for consumption by individuals at schools or hospitals simply 
because it was produced by a farm not subject to part 112 or eligible 
for a qualified exemption.
    (Comment 118) One comment requests that any requirements for 
supplier verification in other FSMA rules should not prevent other food 
businesses from purchasing produce from farms that are eligible for the 
qualified exemption from the produce safety regulation or otherwise not 
subject to the produce safety regulation.
    (Response) Nothing in the produce safety regulation, PCHF 
regulation, or FSVP regulation precludes food businesses from 
purchasing produce grown, harvested, packed, or held by farms that 
qualify for a qualified exemption from the produce safety regulation or 
are otherwise not subject to the produce safety regulation. In the 
rulemakings establishing the PCHF regulation (80 FR 55908) and FSVP 
regulation (published elsewhere in this issue of the Federal Register), 
FDA explained how the supplier verification requirements in those rules 
relate to farms that are not subject to the produce safety regulation.
2. Calculating Farm Sizes
    (Comment 119) Some comments request clarification on how sales will 
be calculated for the purpose of determining a farm's size and, 
therefore, whether the farm is a covered farm, eligible for a qualified 
exemption, and/or eligible for an extended compliance period. Comments 
ask whether the value of produce donated to non-profit organizations 
such as food banks and senior centers would be counted towards sales. 
In addition, comments ask whether sales or donations to public 
institutions, such as prisons, would be counted towards sales.
    (Response) For purposes of the sales thresholds in this rule, FDA 
does not consider a donation in which there is no payment of money or 
anything else of value in exchange for produce to be a ``sale.'' Such 
donations, including to public institutions or non-profit 
organizations, are not counted toward a farm's sales revenue. However, 
sales of produce to any public institutions or non-profit organizations 
in which money or anything else of value is exchanged for produce must 
be counted as sales for purposes of this rule.
    (Comment 120) Some comments seek clarification on the applicability 
of small or very small business definitions in proposed Sec.  112.3 
versus the eligibility criteria for a qualified exemption in Sec.  
112.5 in the circumstance where a farm meets the conditions for both. 
Some comments point out that because the monetary thresholds are based 
on produce sales for the former and all food sales for the latter, it 
would be possible for certain diversified farms to qualify for extended 
compliance periods (as small or very small businesses) as well as for a 
qualified exemption and modified requirements. Additionally, one 
commenter is concerned that this difference in monetary threshold basis 
means that a farm will have to be aware of the implications of its sale 
of ``all produce'' and ``all food.''
    (Response) We acknowledge that because of the difference in the 
bases for monetary cut-offs established in Sec.  112.3 and in Sec.  
112.5, there could be circumstances where a farm that is a small 
business or very small business (as defined in Sec.  112.3) is also 
eligible for a qualified exemption (in accordance with Sec.  112.5). 
Farms eligible for a qualified exemption (in accordance with Sec.  
112.5) that also qualify as a small or very small business (as defined 
in Sec.  112.3(b)), must comply with the modified requirements of 
Sec. Sec.  112.6 and 112.7 within the compliance periods established 
for either a small business or a very small business, whichever is 
applicable. A farm can be both a farm eligible for a qualified 
exemption and a small or very small business. We are revising the 
definitions of small business and very small business to acknowledge 
that such businesses may be subject to only some of the requirements of 
part 112, if they are also a farm eligible for a qualified exemption, 
and to all of the requirements of part 112 if they are only a small or 
very small business. We have replaced the phrase ``if it is subject to 
this part'' with ``if it is subject to any of the requirements of this 
part'' in the definitions of both small business and very small 
business in Sec.  112.3(b).
    (Comment 121) Some comments ask whether annual sales will be 
calculated per owner or per operator, where the farm owner and operator 
are different. Other comments ask whether farms may alter their 
business structures for the purpose of evading this rule.
    (Response) We have revised the definition of ``farm'' to make clear 
that the relevant entity is the farm business, which is either (1) A 
Primary Production Farm, an operation under one management in one 
general (but not necessarily contiguous) physical location devoted to 
the growing of crops, the harvesting of crops, the raising of animals 
(including seafood), or any combination of these activities; or (2) a 
Secondary Activities Farm, an operation devoted to harvesting, packing, 
and/or holding of RACs, provided that the primary production farm(s) 
that grows, harvests, and/or raises the majority of the RACs harvested, 
packed, and/or held by the secondary activities farm owns, or jointly 
owns, a majority interest in the secondary activities farm. Thus, a 
farm's sales are those attributable to the farm business. Limits on 
permissible business structures for farms are beyond the scope of this 
regulation. Thus, it is possible that some farms may attempt to evade 
this regulation as suggested by the comment. However, we do not expect 
this to occur on a broad scale given that many farms currently already 
participate in voluntary industry guidelines or marketing agreements, 
many of which include provisions similar to those required under this 
regulation.
    (Comment 122) One comment finds the requirements for calculating 
sales for the purposes of the coverage threshold and the qualified 
exemption to be confusing and notes that small farms may resist a 
financial evaluation to determine the applicability of this rule at the 
beginning of an inspection.
    (Response) The $25,000 coverage threshold is based on sales of 
produce, which we expect a farm to be able to demonstrate using 
existing sales records. The criteria for the qualified exemption are 
more complex, but are a product of requirements in section 419(f) of 
the FD&C Act. In section IX.C.5-7 of this document we discuss how a 
farm can demonstrate its eligibility for the qualified exemption and 
the associated requirement for farms to maintain necessary 
documentation. We expect that farms that are not covered by this rule, 
or that

[[Page 74408]]

are eligible for an exemption, will be willing to provide supporting 
documentation to FDA at relevant times, including during an inspection. 
We intend to target our education efforts on small farms to help them 
come into compliance. We also 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 this rule.
    (Comment 123) Some comments recommend including a multiplier ratio 
in the sales thresholds to take into account the growing seasons of 
different areas. Another comment recommends replacing monetary income 
thresholds for farm size with either produce-unit thresholds or with 
the cost of non-farm inputs purchased.
    (Response) We believe it is unnecessary to include a multiplier 
ratio because we consider total annual production, rather than 
seasonally-adjusted production. We use monetary value of sales of 
produce as a proxy for the quantity of produce sold in the United 
States marketplace. This provides a clearer picture of volume 
contribution to the United States marketplace than produce units or 
cost of non-farm inputs purchased, which do not appear to indicate 
consumption or even yield.
    (Comment 124) Some comments recommend adjusting the sales 
thresholds for all purposes for inflation and recommend using 2011 as 
the baseline year for such adjustment, consistent with the monetary 
threshold for farms eligible for a qualified exemption (Sec.  112.5). 
One comment recommends including adjustments to the sales thresholds in 
the rule based on the Consumer Price Index to account for future 
inflation.
    (Response) We do not agree that the monetary thresholds for 
determining whether a covered farm is a ``small business'' or ``very 
small business'' need to be adjusted for inflation. These thresholds 
are used only to determine the first date upon which a small or very 
small business must comply with the rule, with applicable compliance 
periods ranging from two years to a maximum of six years from the 
effective date of this rule. In contrast, the $25,000 monetary 
threshold in Sec.  112.4(a) affects whether or not a farm is covered 
under this rule, with indefinite effect. Therefore, we agree that this 
monetary threshold should be adjusted for inflation, and we are 
revising Sec.  112.4(a) accordingly. With respect to the monetary 
threshold related to eligibility for a qualified exemption, we are 
finalizing Sec.  112.5, as proposed. Section 112.5(a)(2) provides that 
the $500,000 figure will be adjusted for inflation, and Sec.  112.5(b) 
provides that 2011 is the baseline year for calculating such 
adjustment. We intend to use the federal calculation for inflation 
adjustments provided by the Bureau of Economic Analysis (Ref. 98), and 
to make the adjusted dollar value available on our Internet site.
    (Comment 125) One comment asks how farm size will be calculated if 
a farm has properties in two States.
    (Response) We have revised the definition of ``farm'' to make clear 
that the relevant entity is the farm business. Thus, provided that a 
farm is limited to one general (but not necessarily contiguous) 
physical location, whether a farm's operation crosses State borders 
does not affect the calculations of a farm's size, which are based on 
annual sales.
    (Comment 126) Comments request revisions and/or clarification on 
the applicability of the farm size monetary thresholds to foreign 
farms. Some comments express concern that applying the thresholds 
equally to domestic and foreign farms will have significant unintended 
consequences. Some comments state that the proposed $25,000 threshold 
has significant consequences in relation to imported foods. According 
to these comments, foreign farms that export foods to the United States 
from around the world are often very small, and produce from these 
farms is aggregated for export to the United States. Another comment 
states that any gross sales threshold gives an unfair advantage to 
foreign farms who sell produce at a low price index, disadvantaging 
domestic farmers, who the commenter asserts will sell less produce than 
foreign farmers before exceeding any given threshold. This comment asks 
FDA to define farm size thresholds based on tonnage, with separate 
categories for different classes of produce, rather than on monetary 
value of sales.
    (Response) We do not agree that the coverage threshold presents a 
particular problem with respect to imported produce. Produce is 
aggregated for sale both domestically and abroad. We conclude that the 
farms below the threshold do not contribute significantly to the volume 
of produce in the marketplace that could become contaminated and, 
therefore, have little measurable public health impact. We acknowledge 
that dollar amounts are directly related to product value, but 
nonetheless disagree that we should base the monetary thresholds in the 
rule on the volume or amount of product sold. We see no practical way 
to identify a threshold based on volume or amount of product that could 
be applied across all applicable commodities and operations, and the 
commenter provided no specific suggestions for how this recommendation 
could be carried out.
    (Comment 127) Some comments ask us to count only United States 
sales to calculate the size of foreign farms that export food to the 
United States. Some comments also assert that most foreign farms export 
only a small portion of their total produce to the United States, and 
that this limited volume of produce poses a relatively low risk to 
United States consumers. In addition, one comment also states that 
because the farm's coverage or qualified exemption status would be 
influenced by fluctuations in foreign exchange rates, monetary 
thresholds based on global sales would jeopardize the predictability of 
business and have negative effects on trade.
    (Response) We decline this request. The purpose of the definitions 
of ``very small business'' and ``small business'' in this rule is to 
allow such farms extended periods before their initial compliance with 
the rule. We are providing this flexibility because they may have fewer 
resources to direct to compliance with the rule under the shorter 
timeframes provided to larger farms. As such, we are applying this rule 
equally to foreign and domestic farms of the same size. Just like a 
similarly situated domestic farm, a foreign farm that sells more than 
the threshold dollar amount of food is likely to have the capability of 
complying with the rule within the applicable time period, even if not 
all of that dollar amount reflects United States sales. We also decline 
this request with respect to the monetary threshold in Sec.  112.4(a), 
maintaining consistency to the maximum extent possible. The criteria 
for eligibility for a qualified exemption (and, therefore, associated 
modified requirements) established in Sec.  112.5 are as mandated by 
section 419(f)(1) of the FD&C Act. Because these criteria are mandated 
by the statute, FDA must include them and we are finalizing them, as 
proposed.
    Although it is true that foreign exchange rates fluctuate, we 
believe the effect of such fluctuations on a farm's average revenue 
over a three year period would be minimal. Foreign exchange prices 
fluctuate, but so too, do crop prices. If a covered farm is able to 
make more money either by switching crops or selling to new markets 
overseas these changes in practice could affect the farm's coverage. 
And while such opportunities may present themselves

[[Page 74409]]

in the short term, both crop prices and exchange rates tend to 
stabilize over the long term.
    (Comment 128) Several comments request that farm sizes be based on 
the sale of ``covered produce,'' rather than on the sale of ``all 
produce.'' Although supportive of the change from ``all food'' to ``all 
produce,'' these comments urge FDA to calculate all monetary thresholds 
for businesses based on sales of covered produce to provide what the 
commenters believe would be a clear standard and support farm 
diversification efforts. Some comments argue that section 419 of the 
FD&C Act placed limitations on the scope of the rule that should be 
reflected in the rule's calculation of sales by basing them only on 
food covered by the rule. One commenter asserts that it would not be 
difficult to determine produce that is ``covered'' versus ``not 
covered'' or to keep track of ``produce sold'' versus ``produce grown 
for personal consumption.'' Some commenters opine that defining 
coverage in terms of ``covered produce'' versus ``all produce'' would 
likely continue to cover only a small fraction of the total volume of 
covered produce in the United States food supply, resulting in minimal 
changes to total coverage of the rule. In contrast, some comments 
support FDA's revised provisions, and state that basing farm monetary 
thresholds on ``covered produce'' might be too difficult to be 
practical in that, compared to ``all produce,'' identifying ``covered 
produce'' is distinctly more challenging and will change on a more 
frequent basis.
    (Response) In the supplemental notice, we considered and rejected 
basing farm size on sales of covered produce, and commenters did not 
provide specific suggestions responsive to our stated concerns about 
the feasibility of this approach. This scenario continues to present a 
number of challenges, including the difficulty of determining the scope 
and public health impact of not covering farms based on the sales of 
covered produce, particularly considering the likely variability in 
produce commodities grown year to year; variability resulting from 
provisions under which certain commodities would not be considered 
``covered produce'' (for example, produce that is rarely consumed raw); 
changes in the amount of produce that is used for personal consumption 
or for consumption on the farm or another farm under the same 
management; and whether and how to account for produce that would be 
eligible for exemption under certain conditions, which may be 
inherently variable based on market conditions (for example, produce 
that is destined for commercial processing). We continue to find it 
difficult to quantitatively determine the extent to which businesses 
with an average annual monetary value of ``covered produce'' sold of 
more than $25,000 would contribute to the overall produce market, or 
the public health impact of not covering such businesses under part 
112. However, it can be reasonably expected that applying the same 
monetary thresholds to covered produce sales (rather than to total 
produce sales) would exclude more produce acres and, therefore, a 
larger volume of product potentially associated with foodborne illness. 
Moreover, the possibly frequent changes to a farm's covered or non-
covered status may also be challenging for compliance and enforcement 
purposes. We also disagree that our legal authority requires us to use 
``covered produce'' only as the basis for sales thresholds in this 
rule. As explained elsewhere, the monetary threshold for a qualified 
exemption is established by statute as calculated based on all food, 
and we use this basis in Sec.  112.5. Section 419 gives FDA the 
discretion to define the terms ``small business'' and ``very small 
business,'' and to determine which farms and which produce should be 
covered. For all of these reasons, we are not adopting this approach.
3. Definitions of Small and Very Small Businesses (Sec.  112.3(b)) and 
Extended Compliance Periods
    (Comment 129) A number of comments asked us to raise the sales 
thresholds in the definitions of ``very small business'' and ``small 
business'' set forth in proposed Sec.  112.3(b). These comments cite 
the relative proportion of farms that would meet each definition and 
the economic burden of compliance with the rule as justification. Sales 
thresholds suggested for ``very small business'' and ``small business'' 
ranged across the comments, including suggestions up to $1,000,000 or 
even $2,000,000 in average annual monetary value of sales over the 
previous 3-year period.
    (Response) As required by section 419(a)(3)(A) and (c)(1)(B) of the 
FD&C Act, we have formulated this rule to 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 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. Small businesses and 
very small businesses are provided extended compliance periods as a 
means of providing such businesses with additional flexibility (see 
section XXIV of this document). In the supplemental notice, we revised 
the proposed definitions of small business and very small business by 
replacing the sales thresholds based on sales of all food with sales 
thresholds based on sales only of produce, which we expect would 
increase the number of farms that would fit within those definitions 
and therefore qualify for extended compliance periods (79 FR 58434 at 
58437). Small businesses and very small businesses, as defined for the 
purpose of this regulation, together account for an estimated total of 
17.2 percent of covered produce acres and about 13.6 percent of all 
produce acres in the United States, and are significant contributors to 
the volume of produce marketed in the United States. We considered the 
suggestions to set the monetary thresholds for very small or small 
businesses at $1 million or $2 million. Using these thresholds, applied 
to annual sales of produce, such businesses account for an estimated 
total of 40.6 percent of covered produce acres and about 32 percent of 
all produce acres in the United States for the $1 million cutoff, and 
an estimated total of 54.6 percent of covered produce acres and about 
43 percent of all produce acres in the United States for the $2 million 
cutoff. Neither of these cutoffs is appropriate to consider a business 
as ``very small business'' or ``small business'' because it would delay 
compliance dates significantly for about a third of all produce 
marketed in the United States using the $1 million cutoff, and for 
nearly a half of all produce marketed in the United States using the $2 
million cutoff. We also considered and rejected the possibility of 
basing the thresholds on sales of covered produce, as explained in 
Comment 128. Therefore, we believe that the sales thresholds in the 
definitions of very small business and small business, as revised in 
the supplemental notice, are appropriate, and we are finalizing them as 
proposed in the supplemental notice. We intend to target our education 
and technical assistance efforts to help these farms to comply with the 
standards established in part 112.
    (Comment 130) One comment disagrees with providing extended 
compliance periods for small and very small businesses, stating that 
these provisions would allow such farms to operate at increased risk 
for a significant time.

[[Page 74410]]

    (Response) We are providing extended compliance periods for small 
and very small businesses to incorporate additional flexibility into 
the regulation, consistent with the statutory provisions in section 
419(a)(3)(A) and (c)(1)(B) of the FD&C Act, which direct us to provide 
sufficient flexibility to be practicable for all sizes and types of 
businesses, including small businesses. Small and very small businesses 
may have fewer resources available to, for example, invest in new 
equipment, or fewer staff with formal training in food safety and, 
therefore, may need additional time to come into compliance with the 
regulation. Providing extended compliance periods to small and very 
small businesses is consistent with our approach to compliance dates in 
recent rules directed to food safety (see, e.g., 74 FR 33029 at 33034, 
July 9, 2009 and 72 FR 34751 at 34752, June 25, 2007). This allowance 
for extended compliance periods does not eliminate or otherwise affect 
their responsibility under the FD&C Act to ensure the safety of their 
produce.
4. The $25,000 Threshold for Coverage Under the Rule (Sec.  112.4(a))
    (Comment 131) Several comments support the proposed threshold of 
more than $25,000 in average annual monetary value of produce sales 
during the previous 3-year period. Some comments request that the 
threshold be raised. These comments recommend varying thresholds 
ranging from $75,000 to $5,000,000 of annual sales of either produce, 
covered produce, or all food. One comment suggests that the threshold 
should be higher than the majority of farms that could reasonably be 
considered viable family-sustaining businesses. Other commenters 
suggest using a threshold in line with an average single family income.
    Other comments object to the inclusion of any monetary or otherwise 
size-based threshold for coverage under this rule. These comments argue 
that this approach creates an ``uneven playing field'' advantaging 
small farms over large farms, that pathogens do not discriminate based 
on the size of a farm, that such a threshold will minimize the impact 
of this rule in terms of consumer confidence in the safety of produce, 
and that small farms are nevertheless able to comply in a cost-
effective manner with the same best practices for food safety that 
larger producers follow. Some comments also argue that inclusion of 
such a threshold puts pressure on State and local agencies to regulate 
the smallest farms, and that the smallest operations may be the highest 
risk for hazards and contamination because large farms typically 
utilize third-party audits but smaller farms do not.
    (Response) We believe it is appropriate to establish a threshold 
for coverage of this rule to establish only those requirements that are 
reasonably necessary to meet the public health objectives of the 
regulation. Because farms below the threshold do not contribute 
significantly to the volume of produce in the marketplace that could 
become contaminated, we conclude that imposing the requirements of part 
112 on these businesses is not warranted. We note that farms that are 
not subject to this rule are and will continue to be covered under the 
adulteration and other applicable provisions of the FD&C Act and 
applicable implementing regulations, irrespective of whether they are 
included within the scope of this rule. We recommend that farms that 
are not covered under part 112 follow good agricultural practices to 
ensure that the produce they grow, harvest, pack or hold does not serve 
as a vehicle for foodborne illness.
    In the supplemental notice, we revised the proposed $25,000 
threshold for coverage by replacing sales of ``food'' with sales only 
of ``produce.'' We tentatively concluded that the farms below this 
revised proposed threshold would not contribute significantly to the 
volume of produce in the marketplace that could become contaminated 
and, therefore, would have little measurable public health impact. We 
believe that applying the limit to produce sales rather than all food 
sales would accommodate the concerns expressed by some comments without 
adversely affecting the level of public health protection envisioned 
under the 2013 proposed rule (79 FR at 58434 at 58437). We are 
finalizing the $25,000 threshold, based on sales of produce, as 
proposed in the supplemental notice. Our analysis shows that farms with 
less than $25,000 of annual produce sales account for an estimated 
total of 2.5 percent of covered produce acres, and about 2 percent of 
all produce acres in the United States. Such businesses do not 
contribute significantly to the volume of produce in the marketplace 
that could become contaminated and, therefore, we believe that imposing 
the requirements of part 112 on these businesses is not warranted. We 
also considered and rejected the possibility of basing the threshold on 
sales of covered produce, as explained in Comment 128.
    We also considered alternative monetary value thresholds suggested 
by commenters. We find that setting a monetary threshold greater than 
$25,000 based on sales of produce would adversely affect the level of 
public health protection provided by this regulation. For example, if 
we were to set the coverage threshold at $1 million or $2 million, 
applied to sales of produce, an estimated total of about 32 percent of 
all produce acres in the United States for the $1 million cutoff and an 
estimated total of about 43 percent of all produce acres in the United 
States for the $2 million cutoff would not be subject to this rule. 
This would remove about a third to nearly half of all produce marketed 
in the United States from coverage, providing significantly less public 
health protection. We have incorporated flexibility in the rule to help 
smaller farms to comply. We also intend to work with our State, tribal, 
and local partners and target our education and technical assistance 
efforts to smaller farms to help farms meet the standards established 
in subparts A to O, within the specified compliance periods.
5. Qualified Exemptions Generally (Sec. Sec.  112.5 and 112.6)
    (Comment 132) Several comments express support for the qualified 
exemption provisions for farms, as proposed, and urge FDA to retain the 
modified requirements for such farms. Conversely, some comments oppose 
the proposed qualified exemption provisions and recommend that this 
exemption be eliminated, arguing that it is not science- or risk-based.
    (Response) As explained in the 2013 proposed rule, the provisions 
in Sec. Sec.  112.5 and 112.6 reflect the fact that section 419(f) of 
the FD&C Act mandates this exemption. Section 112.5 establishes the 
criteria for eligibility for a qualified exemption (and, therefore, 
associated modified requirements) based on a farm's average monetary 
value of all food sold and direct farm marketing, as mandated by 
section 419(f)(1) of the FD&C Act. Similarly, Sec.  112.6 establishes 
the modified requirements applicable to those farms that are eligible 
for a qualified exemption as mandated by section 419(f)(2) of the FD&C 
Act. Because these provisions are mandated by the statute, FDA must 
include them and we are finalizing them as proposed. We note, however, 
that the qualified exemption from part 112 does not eliminate a farm's 
responsibility to comply with all applicable requirements of the FD&C 
Act. We encourage such farms to continue following procedures, 
processes, and practices that ensure the safety of produce grown, 
harvested, packed, or held on their farm or in their operation.

[[Page 74411]]

6. Criteria for Eligibility for a Qualified Exemption (Sec.  112.5)
    (Comment 133) Some comments suggest altering the criteria for 
eligibility for a qualified exemption in various ways. One comment 
recommends exempting farms that sell at least 50 percent of their 
produce directly to consumers or retail stores within a 250-mile 
radius, and argues that buyers in such circumstances can visually 
inspect the growing areas, converse with farmers, and closely examine 
their purchasing options. Another comment recommends increasing the 
average annual sales monetary limit for eligibility for a qualified 
exemption from $500,000 to a minimum of $1,000,000. This commenter 
states that the $500,000 limit in Sec.  112.5(a) would not adequately 
protect smaller farms, particularly because it would be applied to all 
food sales. In this regard, the commenter also recommends that the 
monetary value limit should be applied to the sale of covered produce 
only, and not all food. Another comment recommends applying the 
monetary value limit to sales of produce.
    (Response) Sections 112.5, 112.6, and 112.7 establish the criteria 
for eligibility for a qualified exemption and associated modified 
requirements, consistent with section 419(f) of the FD&C Act (21 U.S.C. 
350h(f)). The criteria established in Sec.  112.5(a), including the 
requirements related to sales directly to qualified end-users, are 
derived from section 419(f) of the FD&C Act. Similarly, the definition 
of a qualified end-user in Sec.  112.3(c) implements section 419(f)(4) 
of the FD&C Act. Because these provisions are mandated by the statute, 
FDA must include them and we are finalizing them as proposed. We have 
identified no basis that would allow us to make the changes suggested 
by the commenters, such as applying a distance criterion of 250 miles, 
applying a monetary limit of $1,000,000, or changing the basis for the 
monetary limit to apply to sales of produce or covered produce rather 
than all food. We also addressed this last request regarding monetary 
limit based on sales of covered produce in the supplemental notice (see 
79 FR 58434 at 58438).
    (Comment 134) Several comments request that FDA allow small farms 
that market through produce auctions or CSA operations to be eligible 
for the qualified exemption.
    (Response) Consistent with section 419(f) of the FD&C Act, the 
provisions in Sec.  112.5 do not identify any produce market 
arrangements as specifically eligible for the qualified exemption. 
Rather, these provisions establish the criteria that must be met for 
any covered farm to be eligible for a qualified exemption. As we 
discussed in the 2013 proposed rule (78 FR 3504 at 3549-50), it does 
seem likely that many farms that use arrangements such as CSAs, you-
pick operations, or farmers markets, will meet the established criteria 
for a qualified exemption. Each covered farm, including farms using 
such arrangements to market their produce, should analyze its sales 
under the terms of Sec.  112.5 to determine its eligibility for the 
qualified exemption.
    In the case of a CSA farm or a farm using a produce auction as a 
sales platform, the farm's direct sales to individual consumers 
enrolled in the CSA operation, or individual consumers at the auction, 
can be counted as sales to qualified end-users (because consumers are 
qualified end-users, regardless of location). A direct sale to a 
restaurant or retail food establishment enrolled in the CSA or at the 
auction can be counted as a sale to a qualified end-user if the 
restaurant or retail food establishment is located either in the same 
State or the same Indian reservation as the farm or is located not more 
than 275 miles from the farm. Considering sales of all food, if the 
farm's sales to qualified end-users exceeds sales to all other buyers, 
and the farm's average annual monetary value of sales over the previous 
3-year period is less than $500,000, the farm would be eligible for the 
qualified exemption.
    The definition of a ``qualified end-user,'' which is derived from 
section 419(f)(4) of the FD&C Act, explicitly states that the term 
``consumer'' does not include a business. In a circumstance where the 
CSA farm sells its produce to a separate business that runs a CSA, 
rather than directly to individual consumers enrolled in the CSA, these 
sales would not be sales to consumers. The analysis is the same in a 
circumstance where a farm sells its produce to a separate business that 
runs a produce auction, rather than directly to specific buyers at the 
auction. Such sales would only be sales to a qualified end-user if the 
CSA operation, or the produce auction, fits the definition of a retail 
food establishment or a restaurant, and meets the location requirements 
explained previously. As noted in response to Comment 103, FDA is 
addressing the definition of ``retail food establishment'' in a 
separate rulemaking. This rulemaking includes topics related to various 
types of sales platforms and the definition of ``retail food 
establishment.''
7. Applicable Requirements for Qualified Exemption (Sec. Sec.  112.6 
and 112.7)
    (Comment 135) One comment requests that we clarify the cross-
references in Sec.  112.6(a) regarding the subparts applicable to farms 
eligible for the qualified exemption.
    (Response) We are amending Sec.  112.6(a) to provide the requested 
clarification, separating applicable subparts and including their 
titles.
    (Comment 136) Some comments ask whether the required content of the 
label and point of purchase display requirements in Sec.  112.6(b) 
includes only the name and address of the farm, or whether the 
notification must also include a statement notifying consumers of the 
farm's qualified exemption from the produce safety regulation.
    (Response) Label and point of purchase displays required under 
Sec.  112.6(b) must include the name and the complete business address 
of the farm where the produce was grown. You are not required to 
include a statement notifying consumers of your qualified exemption.
    (Comment 137) We requested comment on the feasibility of the 
labeling and point of purchase display provisions in Sec.  112.6(b), 
particularly in the case of consolidating produce from several farm 
locations. One comment states that our request was confusing and, 
assuming that we meant produce from multiple locations of one farm is 
packed or held at one location, the farm name and business address that 
is required to be displayed under Sec.  112.6(b) should be the name and 
business address of the farm that is eligible for the qualified 
exemption.
    (Response) We agree that the relevant farm for purposes of the 
requirements in Sec.  112.6(b) is the farm where the produce was grown 
that is eligible for the qualified exemption. We acknowledge that our 
request for comment was unclear. We did not receive comments suggesting 
that consolidating (or commingling) produce from different farms would 
create a feasibility problem with respect to this requirement. We are 
finalizing the requirement as proposed. If needed, we will consider 
issuing guidance in the future with respect to the application of this 
requirement when produce from different farms has been commingled.
    (Comment 138) Some commenters question the requirement to disclose 
the name and business address of a farm eligible for the qualified 
exemption, citing concerns about biosecurity and unannounced or 
unplanned visitors to the farm. These comments suggest that

[[Page 74412]]

FDA consider alternative approaches. One comment points out that farms 
that sell to local retailers, restaurants, co-ops or that sell at 
produce auctions are often assigned a farm identification number as a 
means of traceability, and suggests that FDA consider relying on such 
identification. Another comment suggests providing flexibility for 
farms to choose whether to disclose its phone number, Web site, email 
address, or business address.
    (Response) Sections 112.6 and 112.7 establish the modified 
requirements applicable to farms that meet the criteria under Sec.  
112.5 for a qualified exemption. As explained in the 2013 proposed 
rule, these requirements are derived from the provisions in section 
419(f)(2) of the FD&C Act. We 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 (under Sec.  112.5). 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. 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 (78 FR 3504 at 3550.). Similarly, if Congress had intended 
that other information (such as a farm identification number, phone 
number, Web site, or email address) could substitute for the required 
information, there would have been no need to impose the specific 
requirement for the business address to be disclosed. Section 112.6(b) 
does not prevent farms from voluntarily disclosing such additional 
information if desired. We consider that Congress has already struck 
the specific balance it intended between farms' need to control visitor 
access to the farm for biosecurity purposes and the amount of 
information required to be disclosed to consumers when a farm is 
eligible for a qualified exemption from this rule. Therefore, we are 
finalizing Sec.  112.6(b), as proposed.
    (Comment 139) Comments generally support FDA requiring farms 
eligible for the qualified exemption to maintain adequate documentation 
to demonstrate the basis for their qualified exemption, and to make 
such records available to FDA for inspection upon request. One comment 
asks that FDA not require farms eligible for the qualified exemption to 
submit documentation to FDA or to establish and maintain records in 
accordance with subpart O, and suggests issuing recordkeeping guidance 
for these farms instead.
    (Response) If farms were not required to maintain adequate 
documentation of their eligibility for a qualified exemption, we would 
have no way to determine whether a farm claiming the qualified 
exemption, in fact, met the criteria for that exemption. This could be 
important, for example, if a farm claiming a 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 discussion of subpart R in 
section XXIII of this document). In such circumstance, because the 
withdrawal procedures in subpart R would only apply to farms eligible 
for the qualified exemption, we would need to verify the status of a 
farm to consider appropriate follow-up actions, in accordance with 
subpart R. Therefore, we are adding a new provision Sec.  112.7 to 
establish certain recordkeeping requirements in relation to a qualified 
exemption.
    However, we agree that it is not necessary for farms to submit 
documentation to FDA of their status with respect to the qualified 
exemption, unless FDA requests such information for official review 
(for example, during an inspection or investigation). We also do not 
oppose the use of existing records or documents (for example, documents 
that are developed and maintained during the normal course of a farm's 
business) to document the farm's eligibility for a qualified exemption, 
provided that they meet all applicable requirements.
    Specifically, in new Sec.  112.7, we are requiring that, if you are 
eligible for a qualified exemption in accordance with Sec.  112.5, you 
must establish and keep records required under this provision in 
accordance with the requirements of subpart O of this part. This means 
that the general requirements for maintenance of records in subpart O 
apply to the records required under Sec.  112.7, except that we are not 
requiring sales receipts kept in the normal course of business to be 
signed or initialed by the person who performed the sale (Sec.  
112.7(a)). Under Sec.  112.7(b), we are requiring that you must 
establish and keep adequate records necessary to demonstrate that you 
satisfy the criteria for a qualified exemption as described in Sec.  
112.5. Such records may include receipts of your sales to different 
buyers; the location of any buyers that are restaurants or retail food 
establishments; the monetary value of sales of all food, adjusted for 
inflation using 2011 as the baseline year; and any other documentation 
that FDA can use, as necessary, to verify your eligibility for a 
qualified exemption. For example, if you relied on records kept in the 
normal course of your business bearing on the criteria for the 
qualified exemption to determine your eligibility, you must retain such 
records. Under Sec.  112.7(a) we are not requiring sales receipts kept 
in the normal course of business to be signed or initialed by the 
person who performed the sale. We are requiring that such receipts be 
dated, however, because the dates of sales are relevant to the 
computation of eligibility.
    Because the criteria for eligibility for a qualified exemption are 
based on calculations regarding the preceding 3-year period (see Sec.  
112.5(a)(2)), you must review your sales annually to confirm your 
continued eligibility for the qualified exemption for the upcoming 
year. Under Sec.  112.7(b), we are now specifying that you must 
establish and keep a written record reflecting that you have performed 
an annual review and verification of your farm's continued eligibility 
for the qualified exemption. Under Sec.  112.161(a)(4), these records 
must be dated, and signed or initialed by the person who performed the 
activity documented. Thus, we expect that the annual review and 
verification document will be signed and dated by the owner, operator, 
or agent in charge of the farm. We believe it is necessary for the 
party responsible for the covered farm to attest to the status of the 
farm with respect to the qualified exemption. As we noted with regard 
to Sec.  112.161(a)(4) in the 2013 proposed rule, the signature of the 
individual who made the observation (in this case, the annual review 
and verification of eligibility for the qualified exemption) will 
ensure responsibility and accountability. Moreover, any FDA action 
related to withdrawal of the qualified exemption, if necessary,

[[Page 74413]]

would be directed to the owner, operator, or agent in charge of the 
farm, in accordance with subpart R of part 112. In accordance with 
subpart O, records required under this provision must be available and 
accessible to FDA for review upon request within 24 hours (see Sec.  
112.166). We will consider issuing guidance on the types of records or 
documents that may be used to demonstrate a farm's status with respect 
to the qualified exemption.
    We also are establishing an earlier compliance date for the records 
that a farm maintains under Sec.  112.7 to support its eligibility for 
a qualified exemption in accordance with Sec.  112.5. Specifically, the 
compliance date for a farm to retain records to support its status 
under this provision (e.g., sales receipts and other records as 
applicable) is the effective date of this rule, i.e., January 26, 2016. 
Farms need not comply with the requirement for a written record 
reflecting that the farm has performed an annual review and 
verification of continued eligibility for the qualified exemption until 
the farm's general compliance date, however. Even with this earlier 
compliance date for the records supporting eligibility for the 
qualified exemption, we realize that although the calculation in the 
codified is based on 3 calendar years, there may be circumstances where 
a farm will not be required to have 3 calendar years of records as of 
their general compliance date. Under such circumstances, it would be 
reasonable for the farm to make the calculation based on records it has 
(i.e., for one or two preceding calendar years), and we will accept 
records for the preceding one or two years as adequate to support its 
eligibility for a qualified exemption in these circumstances. When a 
farm does not begin operations until after relevant compliance dates 
have passed, it would be reasonable for the farm to rely on a projected 
estimate of revenue (or market value) when it begins operations. We 
would evaluate the credibility of the projection considering factors 
such as the farm's number of employees. After the farm has records for 
one or two preceding calendar years, it would be reasonable for the 
farm to make the calculation based on records it has (i.e., for one or 
two preceding calendar years) and we will accept records for the 
preceding one or two years as adequate to support its eligibility for a 
qualified exemption in these circumstances. See also section XXIV of 
this document.

X. Subpart B--Comments on General Requirements

    In proposed subpart B of part 112, we proposed to establish the 
general requirements applicable to persons who are subject to this part 
(Sec.  112.11) and to establish a framework for alternatives to certain 
requirements established in this part that would be permitted, under 
specified conditions (Sec.  112.12). We asked for comment on all 
provisions in subpart B.
    We are finalizing these provisions with revisions (see Table 8). We 
discuss these changes in this section. We are finalizing the other 
provisions of subpart B without change.

             Table 8--Description of Revisions to Subpart B
------------------------------------------------------------------------
       Final provision                  Description of revisions
------------------------------------------------------------------------
Sec.   112.12................  --Revision to refer to new Sec.   112.49,
                                which lists all of the requirements in
                                subpart E for which we allow the use of
                                alternatives.
                               --Revision to eliminate proposed Sec.
                                112.12(a)(2), consistent with revisions
                                to proposed Sec.   112.54.
                               --Revision to replace ``listed in'' in
                                proposed Sec.   112.12(b) and (c) with
                                ``specified in'' to reflect new
                                reference to Sec.   112.49.
                               --Revision to delete ``(including the
                                same microbiological standards, where
                                applicable)'' and ``including agro-
                                ecological conditions and application
                                interval'' as unnecessary in light of
                                other revisions.
                               --Revision to clarify in Sec.   112.12(c)
                                that ``You are not required to notify or
                                seek prior approval from FDA regarding
                                your decision to establish or use an
                                alternative under this section.''
------------------------------------------------------------------------

A. General Requirement in Sec.  112.11

    (Comment 140) One comment states that the definition and 
application of the term ``reasonably'' is unclear in Sec.  112.11, and 
expresses concern about disagreements between farmers and FDA over what 
measures are reasonably necessary to prevent the introduction of known 
or reasonably foreseeable hazards and provide reasonable assurances 
that the produce is not adulterated.
    (Response) In Sec.  112.3, we revised our proposed term 
``reasonably foreseeable hazard'' and corresponding definition to now 
use ``known or reasonably foreseeable hazard'' to mean a biological 
hazard that is known to be, or has the potential to be, associated with 
the farm or the food. We provide a definition for this phrase as it is 
used in section 419(c)(1)(A) of the FD&C Act and reflected in several 
requirements that we are establishing in part 112. The use of this 
phrase in the produce safety regulation is also consistent with its use 
in the PCHF and PCAF regulations.
    (Comment 141) Some comments express concern about the possibility 
of indirect contamination of covered produce by animal excreta. 
Comments state that animal fecal matter could reach produce through 
indirect means, such as irrigation water, runoff, wind-blown dust, or 
vehicles, particularly in areas where dairies and feedlots exist close 
to farms producing covered produce. In addition, one comment suggests 
that farms should be required to assess their farm for the possibility 
of airborne contamination and should take reasonable steps to avoid it, 
whereas another comment suggests that farms should assess and mitigate 
the potential for contamination by runoff from storage areas.
    (Response) We agree that animal fecal matter may reach produce 
through indirect means. However, various other provisions under part 
112 (in particular, within subparts E and F) that focus on the safety 
of agricultural water, biological soil amendments of animal origin, and 
other growing considerations already address the routes of 
contamination that we identified in the QAR. In addition, we have 
included a requirement in Sec.  112.11, under which covered farms are 
required to 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. As we explained in the 2013 proposed rule, among other 
things, Sec.  112.11 accounts for the variety of possible circumstances 
that might arise in which unique farm circumstances

[[Page 74414]]

would justify preventive measures. Thus, for example, if a farm's 
circumstances are such that airborne or runoff fecal contamination is a 
known or reasonably foreseeable hazard to the farm's covered produce, 
the farm must take those measures reasonably necessary to prevent 
introduction of those hazards and to provide reasonable assurances that 
the produce is not adulterated on account of those hazards.

B. General Comments About Alternatives in Sec.  112.12

    (Comment 142) Several comments spoke to the use of alternatives 
generally. Some comments generally support the allowance for use of 
alternatives and state that alternatives provide flexibility for 
covered farms to consider and accommodate the particularities of the 
commodities, practices and conditions specific to their operations and 
new scientific information, as it becomes available. On the other hand, 
some comments express concern that the provision on use of alternatives 
is unclear, limited in scope, burdensome, and/or is not a realistic 
option for farmers. One comment states that by requiring farmers to 
have adequate scientific data or information to show that the 
alternative would provide the same level of public health protection as 
the applicable requirement, FDA is placing the burden on farmers and 
private entities to conduct research on public health risks generally. 
The commenter believes this is a research and investigative task that 
FDA should fulfill.
    (Response) We agree that the allowance for use of alternatives in 
Sec.  112.12 provides flexibility for covered farms and disagree that 
the allowance for the use of alternatives is unclear, too limited in 
scope, or burdensome. We are providing for the use of alternatives to 
certain minimum science-based requirements that we have established in 
part 112 in order to provide flexibility for farms to identify measures 
that are suitable for their operations, in light of conditions, 
processes, and practices on their farms and that provide the same level 
of public health protection as the applicable requirement. FDA has 
conducted the necessary scientific evaluation to determine reasonable 
measures that are broadly applicable across a wide range of conditions, 
and this scientific analysis is reflected in the codified requirements 
for which alternatives are permitted. Our decision to allow the use of 
alternatives in lieu of the established requirements does not negate 
the underlying scientific basis upon which those requirements are 
derived. Rather, we determined that, in the case of certain specified 
requirements, alternative measures may be demonstrated to be 
scientifically valid, considering the practices and conditions on a 
farm and circumstances unique to a specific commodity or types of 
commodities and in light of evolving science. FDA cannot reasonably 
conduct the necessary scientific evaluation for every set of 
circumstances that exist on covered farms.
    (Comment 143) Some comments assert that FDA should recognize 
certain guidance (commodity-specific or otherwise), as meeting the 
requirements for alternatives in Sec.  112.12. See also comments under 
section IV.F of this document. For example, one comment states the 
Citrus GAPs developed and implemented by the citrus industry should be 
recognized by FDA as an acceptable alternative or variance under the 
produce safety regulation.
    (Response) In accordance with Sec.  112.12(c), for any alternative 
that you use under the provisions of Sec.  112.12(a), you must 
establish and maintain documentation of scientific data or information 
in support of your alternative. The scientific data or information may 
be developed by you, available in the scientific literature, or 
available to you through a third party. Such scientific support may be 
derived from or include commodity-specific or other guidance or 
recommendations (or the science underlying such guidance or 
recommendations), including those developed by industry, academia, 
trade associations, or other stakeholders. Such guidance or 
recommendations, taken together with any other scientific data or 
information on which you rely, must satisfy the requirements in Sec.  
112.12(b) to support the use of the alternative.
    We decline the request that FDA recognize certain commodity-
specific guidelines developed by industry (such as the Citrus GAPs) as 
an acceptable alternative to the produce safety regulation. 
Alternatives are permitted for only certain of the specified 
requirements of part 112, specifically related to agricultural water, 
which are listed in Sec.  112.49 and cross-referenced in Sec.  
112.12(a), and not for all of the provisions of the produce safety 
regulation, in general. Moreover, you do not need to notify or seek 
approval from FDA prior to establishing and using an alternative, and 
we are revising Sec.  112.12(c) to add a sentence making this clear. To 
the extent this commenter requests FDA to consider existing commodity-
specific industry guidelines under the variance provisions in subpart 
P, such requests must be submitted by a State, tribe, or foreign 
government to FDA using the citizen petition process in Sec.  10.30. We 
ask industry to work with their relevant State, tribe, or foreign 
government agencies to submit such requests to FDA, following the 
provisions in subpart P of part 112.
    (Comment 144) One comment suggests that we should expand the 
entities eligible to establish alternatives beyond States and foreign 
governments to include entities such as commodity boards and State 
associations.
    (Response) This comment appears to be confusing the provision 
allowing farms to establish certain alternative standards and processes 
in subpart B, Sec.  112.12, with the provisions allowing States, 
tribes, and foreign governments to request variances from one or more 
requirements of the rule in subpart P, Sec. Sec.  112.171-112.182. 
Unlike the variance provisions, the alternative provisions do not 
require submission of a request by a State, tribe, or foreign 
government to FDA before a covered farm may use a procedure, process, 
or practice that varies from the requirements established in this rule. 
See our discussion of the variance provisions and entities eligible to 
request a variance in section XXI of this document.

C. Alternatives for Additional or All Requirements

    (Comment 145) Several comments ask us to permit the use of 
alternatives for all provisions of the rule, rather than to restrict 
the use of alternatives to only those specified by FDA in the 
regulation. Comments state that it is unclear why FDA limited the use 
of alternative approaches to only the provisions listed in proposed 
Sec.  112.12, and argue that the same option of using alternative 
methods should be applicable to all requirements of the rule. Some 
comments specifically identified provisions related to animals (subpart 
I), worker health and hygiene (subpart D), microbial quality 
requirements (proposed Sec.  112.44(a) for certain uses of agricultural 
water and proposed Sec.  112.55 for soil amendment treatment 
processes), and water testing frequency (proposed Sec.  112.45) as 
additional provisions for which we should allow alternatives.
    (Response) As discussed in the 2013 proposed rule, given various 
considerations, we proposed an integrated approach that draws on our 
past experiences and appropriately reflects the need to tailor 
requirements to specific on-farm routes of contamination. In some 
cases, our standards are very similar to those contained in the Food 
CGMP regulation, especially where the routes of contamination are well-
understood and

[[Page 74415]]

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 are not 
convinced by comments suggesting that we should allow alternatives for 
these types of provisions because these measures are well-established, 
generally applicable, and flexible enough to apply across the spectrum 
of farming conditions and practices. Moreover, these types of 
provisions do not involve specific numerical criteria.
    In other cases, our standards require 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 
assessment related to animal intrusion in Sec.  112.83 and inspection 
of agricultural water system in Sec.  112.42). We are not convinced by 
comments suggesting that we should allow alternatives for these types 
of provisions because these provisions already provide built-in 
flexibility as a result of their monitor-and-respond structure. 
Moreover, these types of provisions do not involve specific numerical 
criteria.
    In still other cases (e.g., sprouts), our standards require the 
farm to develop a written plan, committing itself to specific measures 
(e.g., sprout environmental testing and spent sprout irrigation water 
testing). The use of written plans is important, for example, 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). We are not convinced 
by comments suggesting that we should allow alternatives for these 
types of provisions because they also provide built-in flexibility as a 
result of their structure. Moreover, these types of provisions do not 
involve specific numerical criteria.
    Finally, in certain other cases, we are establishing 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., standards for 
agricultural water in subpart E; and standards for biological soil 
amendments of animal origin in subpart F). We rely on the numerical 
standards approach where our evaluation of current scientific 
information to determine reasonable measures allows us to establish 
numerical criteria that are broadly applicable across a wide range of 
conditions, while acknowledging that such criteria may be tailored, as 
appropriate, when applied specifically to a commodity (or group of 
commodities) or under a set of farm practices. It is in the case of 
this numerical standards approach that an allowance for alternatives 
may be warranted because, under this approach, there is a concrete 
measurable standard against which the effectiveness of measures that a 
farm may take for its operations can be evaluated. In the absence of 
specific numerical criteria, such as in the case of the other types of 
provisions explained previously, the use of alternative measures would 
not be needed because the standards are inherently flexible and already 
allow the farm to identify and take measures tailored to the practices, 
procedures, and processes specific to that farm's operations. In 
addition, alternatives can potentially be warranted for provisions with 
specific numerical standards in light of their relatively prescriptive 
nature, the diversity of operations, and the likelihood of new or 
emerging science.
    The relevant numerical requirements in Sec. Sec.  112.44(b), 
112.45(b)(1)(i), 112.46(b)(1)(i) and 112.46(b)(2)(i) for which we are 
allowing alternatives include measures that we conclude are appropriate 
to require under a wide range of conditions. However, recognizing that 
other measures, if properly validated, may also be suitable, we are 
providing for the use of scientifically-supported alternatives to these 
required measures.
    With respect to application intervals for certain uses of soil 
amendments, in the 2013 proposed rule, we proposed specific minimum 
application intervals for use of raw manure (proposed Sec.  
112.56(a)(1)(i)) and compost (proposed Sec.  112.56(a)(4)(i)), and we 
proposed to allow alternatives to these minimum application intervals. 
However, in the supplemental notice, we proposed certain amendments to 
proposed Sec. Sec.  112.56(a)(1)(i) and 112.56(a)(4)(i)) removing the 
application interval requirements, which makes the corresponding 
alternatives provisions unnecessary. We are finalizing Sec.  112.56 
with some changes, under which alternatives continue to be unnecessary 
(see section XIV.G of this document).
    For other provisions that include numerical criteria, i.e., 
Sec. Sec.  112.44(a) and 112.55, we considered and have decided that 
the use of alternatives for these provisions is either not appropriate 
or not necessary. Section 112.44(a) lists certain uses of agricultural 
water that present a high risk because the conditions associated with 
those uses of water are conducive to multiplication of pathogens, if 
present. Even a low number of pathogens introduced into or onto covered 
produce through contaminated water during those uses could rapidly 
increase to levels that could present risk of serious adverse health 
consequences or death. Therefore, we adopt an appropriately protective 
generic E. coli standard (zero detectable generic E. coli per 100 mL) 
for uses of agricultural water specified in Sec.  112.44(a), without 
further provision for use of an alternative standard. Section 112.55 
establishes the microbial standards applicable to the treatment 
processes established as acceptable in Sec.  112.54. We do not intend 
Sec.  112.55 to require that farms test their treated biological soil 
amendments for compliance with the microbial standards. Rather, we 
intend these provisions to provide the standards against which 
treatment processes described in Sec.  112.54 must be validated. Farms 
would be able to use treatment processes that are validated to meet the 
relevant microbial standard in Sec.  112.55 without the need to test 
the end products of their treatments to confirm that the microbial 
standard was achieved. Because our revisions to Sec.  112.54(a) already 
provide for the use of any scientifically valid, controlled treatment 
processes that are demonstrated to satisfy the microbial standard in 
Sec.  112.55(a) for L. monocytogenes, Salmonella spp., and E. coli 
O157:H7, further provision under Sec.  112.12 for use of alternatives 
is not necessary. Similarly, because in revised Sec.  112.54(b) we 
already explicitly provide for the use of any scientifically valid, 
controlled treatment process that is demonstrated to satisfy the 
microbial standards in Sec.  112.55(b) for Salmonella and for fecal 
coliforms (see Sec.  112.54(c)(3)), a corresponding alternatives 
provision under Sec.  112.12 is not needed. Given these revisions to 
Sec.  112.54 (see section XIV of this document), we have eliminated 
proposed Sec.  112.12(a)(3) in finalizing Sec.  112.12(a).
    Furthermore, unlike alternatives, variances may be requested for 
any of the provisions of part 112 under the conditions provided in 
subpart P, which

[[Page 74416]]

involve the submission of a citizen petition by a State, tribe, or 
foreign government to FDA. This process builds additional flexibility 
into the rule within limits that allow for FDA to review and approve 
new approaches outside the alternatives allowed by Sec.  112.12. An 
allowance for alternatives to be established and used for all 
provisions of part 112 would make the variance process superfluous.
    For these reasons, we do not believe it is appropriate to provide 
for the use of alternatives for provisions of part 112 beyond those 
listed in Sec.  112.12.

D. Additional Clarification

    (Comment 146) A number of comments ask what is meant by the 
requirement in Sec.  112.12(b) that an alternative ``provide the same 
level of public health protection as the applicable requirement'' and 
how that is to be measured. Some comments seek clarification on the 
types of scientific data and documentation necessary to support the use 
of alternatives.
    (Response) Under Sec.  112.12(a), you may establish an alternative 
to one or more of certain requirements established in subpart E, as 
specified in Sec.  112.49. Because, for clarification, we have listed 
all of the requirements in subpart E for which we permit alternatives 
within new Sec.  112.49, in Sec.  112.12(a), we simply provide a cross-
reference to Sec.  112.49 rather than listing out each of the specific 
requirements for which alternatives are permitted (as we did under 
proposed Sec.  112.12(a)). As a conforming edit, we are changing two 
occurrences of ``listed in [Sec.  112.12(a)]'' in Sec.  112.12(b) and 
(c) to read ``specified in [Sec.  112.12(a)].'' As specified in Sec.  
112.49, in accordance with Sec.  112.12, you may establish and use 
alternatives to the following specific requirements related to 
agricultural water: Sec. Sec.  112.44(b), 112.45(b)(1)(i), 
112.46(b)(1)(i)(A), and 112.46(b)(2)(i)(A).
    Sections 112.44(b), 112.45(b)(1)(i), 112.46(b)(1)(i)(A) and 
112.46(b)(2)(i)(A), all establish requirements for the microbial 
quality, testing, 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.
    The Sec.  112.44(b) microbial water quality criteria are a 
statistical threshold value (STV) of 410 or less CFU of generic E. coli 
per 100 mL of water (STV is a measure of variability of your water 
quality distribution, derived as a model-based calculation 
approximating the 90th percentile using the lognormal distribution) and 
a geometric mean (GM) of 126 or less CFU of generic E. coli per 100 mL 
(GM is a measure of the central tendency of your water quality 
distribution). We are establishing these numerical criteria based on 
our analysis of current scientific information; it relies on an 
underlying dataset that has the necessary scientific rigor and 
describes illness rates due to incidental ingestion that can be 
generalized across different bodies of water. In addition, our 
microbial quality criteria use generic E. coli as an indicator organism 
because the intent is to detect measurable levels of fecal 
contamination and monitor the microbial quality of agricultural water 
(see discussion on 79 FR 58434 at 58443-445; see also (Ref. 44)). 
Nevertheless, we acknowledge that circumstances unique to a farm's 
operation or commodities may justify the use of an alternative 
microbial quality criterion (or criteria). Under Sec.  112.49(a), you 
may establish an alternative to the microbial quality criterion (or 
criteria) using an appropriate indicator of fecal contamination, in 
lieu of the microbial quality criteria we established in Sec.  
112.44(b). We recommend that the scientific data or information to 
support the use of an alternative indicator organism include peer 
reviewed scientific material. An example of a potential alternative 
microbial quality criterion is use of a different fecal indicator 
organism as a basis for a GM and STV that are demonstrated to detect 
measurable levels of fecal contamination in agricultural water used for 
the purposes identified in Sec.  112.44(b). We expect any such 
alternative indicator to be as sensitive to the presence and level of 
fecal pollution as generic E. coli. We also expect that any alternative 
microbial quality criteria that you establish and use, in lieu of the 
FDA-established criteria, would be supported by an equally robust and 
rigorous scientific analysis and would be quantitatively demonstrated 
to be equivalent to the FDA-established criteria, thus ``providing the 
same level of public health protection'' as the FDA-established 
criteria and ensuring that your alternative standard would not increase 
the likelihood that your covered produce will be adulterated. In 
addition, for any use of an alternative indicator, you should also 
consider whether the microbial die-off rate that we established in 
Sec.  112.45(b)(1)(i), if you choose to apply it in conjunction with 
your alternative microbial quality criteria, continues to be 
appropriate.
    Similarly, under Sec.  112.49(b), you may establish an alternative 
to the microbial die-off rate between last irrigation and harvest and 
accompanying maximum time interval established in Sec.  
112.45(b)(1)(i). The microbial die-off rate of 0.5 log per day to 
determine an adequate time interval (in days) between last irrigation 
with untreated water and harvest is established in Sec.  
112.45(b)(1)(i). We derived this die-off rate based on a review of 
currently available scientific literature, and recognize that microbial 
die-off rates are dependent on various environmental factors, including 
sunlight intensity, moisture level, temperature, pH, the presence of 
competitive microbes, and suitable plant substrate. Generally, 
pathogens and other microbes die off or are inactivated relatively 
rapidly under hot, dry, and sunny conditions compared to inactivation 
rates observed under cloudy, cool, and wet conditions. Our analysis led 
us to conclude that a rate of 0.5 log per day provides a reasonable 
estimate of microbial die-off under a broad range of variables to 
include microbial characteristics, environmental conditions, crop type, 
and watering frequency (see discussion on 79 FR 58434 at 58445-446; see 
also (Ref. 45)). In final Sec.  112.45(b)(1)(i), we also stipulate a 
maximum time interval of four consecutive days. Nevertheless, we 
acknowledge that practices and conditions on a farm and circumstances 
unique to a specific commodity could result in higher die-off rates 
between last irrigation and harvest, especially under conditions of 
high ultraviolet radiation, high temperature exposures or low humidity, 
coupled with little or no precipitation and, therefore, we are 
providing for the use of appropriate alternative microbial die-off 
rate(s) and an accompanying maximum time interval. We expect that any 
alternative microbial die-off rate between last irrigation and harvest, 
and an accompanying maximum time interval, that you establish and use, 
in lieu of the FDA-established requirement, would be supported by an 
equally robust and rigorous scientific analysis specific to the region 
and crop, and would be quantitatively demonstrated to be equivalent to 
the FDA-established standard, thus ``providing the same level of public 
health protection'' as the FDA-established standard and ensuring that 
your alternative standard would not increase the likelihood that your 
covered produce will be adulterated.
    In Sec.  112.49(c) and (d), we are providing for the use of 
alternative water testing frequency in lieu of the FDA-established 
required number of samples for the initial survey (established in Sec.  
112.46(b)(1)(i)(A)) and

[[Page 74417]]

the annual survey (established in Sec.  112.46(b)(2)(i)(A)) for the 
testing of untreated surface water. In the 2013 proposed rule, we 
proposed specific numerical requirements for frequency of testing 
agricultural water when used during growing in a direct water 
application method, and we did not propose to allow alternatives to 
these testing frequencies. In the supplemental notice, we made these 
requirements more flexible by proposing a tiered approach to testing 
untreated surface water used for this purpose (proposed Sec.  
112.45(b)), which we are retaining with some changes (final Sec.  
112.46(b)). This approach allows farms to make decisions about safe use 
of available water sources prior to the beginning of the next growing 
season; adjust testing frequencies dependent on long-term test results; 
and ultimately reduce the required frequency of testing. Among the 
testing requirements in Sec.  112.46(b), we specify that a certain 
specified minimum number of samples must be collected for the initial 
and annual surveys. We derived these minimum testing frequencies (i.e., 
the minimum number of samples) from our statistical analysis based on 
average variability among surface water sources (i.e., a standard 
deviation of 0.4) (Ref. 99). In our review of available information 
(Ref. 44) (Ref. 99), we cited that among the water bodies studied by 
EPA in developing the recreational water quality criteria, EPA reported 
an estimate of average standard deviation of log E. coli abundance 
measurements in surface waters is 0.4 (Ref. 100). We acknowledge that 
circumstances unique to the variability of the microbial quality of a 
farm's water source may justify the use of an alternative water testing 
frequency. Therefore, if a covered farm determines through analysis of 
historical samples that the standard deviation of log10 E. 
coli abundance measurements for their surface water source(s) is less 
than 0.4 and the difference is statistically significant, then the farm 
could utilize the lower variability rate to determine the appropriate 
minimum number of samples necessary to establish and characterize the 
microbial quality of the farm's water source(s). We expect that any 
alternative frequency of testing that you establish and use, in lieu of 
the FDA-established minimum number of samples in Sec.  
112.46(b)(1)(i)(A) or 112.46(b)(2)(i)(A), would be supported by an 
equally robust and rigorous scientific analysis and would be 
quantitatively demonstrated to be equivalent to the FDA-established 
testing frequency, thus ``providing the same level of public health 
protection'' as the FDA-established standard and ensuring that your 
alternative standard would not increase the likelihood that your 
covered produce will be adulterated. Note also that this allowance for 
use of an alternative testing frequency relates only to the minimum 
number of samples required under Sec.  112.46(b)(1)(i)(A) and 
112.46(b)(2)(i)(A), and does not extend to the other required elements 
of testing, specified in Sec.  112.46(b). Likewise, we are not 
providing for an alternative to the testing frequency specified in 
Sec.  112.46(b)(1)(i)(B) or (b)(2)(i)(B) for the testing of untreated 
ground water when used during growing in a direct water application 
method because ground water sources are less influenced by external 
sources and, therefore, their water quality is less variable, and we 
conclude the testing frequency we established in Sec.  
112.46(b)(1)(i)(B) and (b)(2)(i)(B) is the minimum necessary to ensure 
the quality of ground water sources for that purpose.
    These provisions for use of alternatives are also responsive to 
comments that expressed concern about FDA-established quantitative 
metrics for water quality or testing in the regulation because the 
commenters believed such generally-applicable numerical criteria may 
not adequately take into account the unique circumstances related to 
different commodities or practices. The allowance for alternatives also 
responds to comments that urged us to incorporate flexibility in any 
established requirement to allow for appropriate changes to the 
microbial quality standards based on advances in scientific information 
on water quality. In light of the specific provisions for which we are 
allowing alternatives in this rule, we are deleting two phrases from 
proposed Sec.  112.12 as unnecessary: ``including meeting the same 
microbiological standards, where applicable,'' and ``including agro-
ecological conditions and application interval.''
    The scientific analysis on which you rely may be developed by you, 
available in the scientific literature, or available to you through a 
third party. It does not need to be published in a peer-reviewed 
journal, although we encourage use of peer-reviewed data and 
information, to the extent available.
    FDA is collaborating with partners on research that will add to the 
scientific information that may help inform specific alternatives. For 
example, in an effort to support scientific research in the area of 
agricultural water, one of FDA's Centers of Excellence, the Western 
Center for Food Safety at University of California, Davis, partnered 
with the Center for Produce Safety to provide seed money through a 
competitive grants program to fund produce safety projects focused on 
agricultural water issues that are topical and/or region specific. 
Research areas that have received funding through this process include 
transfer and survival of organisms on produce after exposure from 
contaminated surface irrigation water, application of biocide 
technology on manure-contaminated irrigation water, the potential role 
of overhead sprinkler irrigation systems in the contamination of 
produce, and the survival of pathogens during the growing, harvesting, 
and storage of dry bulb onions after exposure with contaminated water. 
We intend to disseminate useful scientific information, when available, 
and issue commodity- and region-specific guidance as appropriate, such 
that farmers would be able to consider our recommendations and apply 
the new scientific information to their operations, as appropriate.
    (Comment 147) Some comments recommend that FDA specifically state 
that individual producers or commodities, where there is commonality, 
should be able to rely on scientifically credible research and 
publications of commodity boards and trade associations that support 
potential alternative measures.
    (Response) In Sec.  112.12(c), we provide that the scientific data 
and information used to support an alternative may be developed by you, 
available in the scientific literature, or available to you through a 
third party. The scientific support you rely on to justify the use of 
an alternative can be developed by third parties such as industry or 
trade associations and commodity boards. You may establish the 
alternatives under Sec.  112.12 for which you have adequate data and 
information to support a conclusion that the relevant standards are met 
in light of your covered produce commodities, practices, and 
conditions, in accordance with Sec.  112.12(b). Thus, you must take 
your farm's specific commodities, practices, and conditions into 
account when evaluating the relevant scientific information. There may 
be circumstances in which scientific data and information specific to 
one commodity may be appropriately applied to other commodities, 
conditions, or practices, allowing that data to support alternatives 
across multiple commodities, conditions, or practices. However, such 
generalizations may not always be appropriate. We also intend to

[[Page 74418]]

disseminate useful scientific information, when available, and issue 
commodity- and region-specific guidance as appropriate, such that 
farmers would be able to consider our recommendations and apply the new 
scientific information to their operations, as appropriate.

E. Prior Approval of Alternatives

    (Comment 148) Some comments request us to provide a voluntary 
process for pre-approval of alternatives, either by FDA or by 
recognition of private sector experts. These comments seek protection 
for farms using pre-approved alternatives, as well as guidance for 
farmers and researchers to follow when developing alternatives that 
will meet FDA standards. Similarly, one comment suggests amending 
proposed Sec.  112.12 to specifically state that use of alternative 
procedures does not require prior approval by FDA.''
    (Response) We are not requiring you to notify or seek prior 
approval from FDA regarding your decision to establish or use an 
alternative or to otherwise submit relevant scientific data or 
information to FDA prior to using an alternative. We are adding an 
explicit statement to Sec.  112.12 that FDA pre-approval of 
alternatives is not required. However, we note that if FDA determines 
that the use of an alternative is not in compliance with the provisions 
of Sec.  112.12, FDA may take enforcement or other action, as 
appropriate. However, we are requiring that you maintain a record of 
any such scientific data or information, including any analytical 
information, under Sec.  112.12(c), and make such data and information 
available to us to evaluate upon request, under Sec.  112.166. We are 
not establishing a voluntary pre-approval process; however, FDA intends 
to continue encouraging and supporting development of useful scientific 
data and information, as well as conducting significant education and 
outreach related to this rule. We also intend to disseminate useful 
scientific information, when available, and issue commodity- and 
region-specific guidance as appropriate, such that farmers would be 
able to consider our recommendations and apply the new scientific 
information to their operations, as appropriate.

XI. Subpart C--Comments on Personnel Qualifications and Training

    In subpart C of proposed part 112, we proposed 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. We asked for comment on our proposed 
provisions, including the proposed requirements for training on 
principles of food hygiene and food safety and the feasibility of the 
proposed training requirements, particularly with respect to harvest 
activities.
    We are finalizing these provisions with revisions (see Table 9). We 
discuss these changes in this section. For Sec.  112.23, we did not 
receive any comments or received only general comments in support of 
the proposed provision and, therefore, we do not specifically discuss 
this provision.

             Table 9--Description of Revisions to Subpart C
------------------------------------------------------------------------
       Final provision                  Description of revisions
------------------------------------------------------------------------
Sec.   112.21(a).............  --Revision such that required training
                                must be repeated periodically
                                thereafter, at least once annually.
Sec.   112.21(b).............  --Revision to require that personnel must
                                have a combination of education,
                                training, and experience necessary to
                                perform the person's assigned duties.
Sec.   112.22................  --Revision to change ``should'' to
                                ``must'' in Sec.   112.22(b)(1).
Sec.   112.30................  --No change.
------------------------------------------------------------------------

A. General Comments

    (Comment 149) One comment expresses concern that under subpart C, 
as proposed, agricultural workers are viewed as ``disease vectors'' and 
a ``potential pathway for contamination'' rather than as ``fundamental 
partners.''
    (Response) Agricultural workers are invaluable and fundamental 
partners in ensuring food safety on the farm. However, as discussed in 
the 2013 proposed rule, it is well-documented in the scientific 
literature that bacteria, viruses, and parasites are frequently 
transmitted from person to person and from person to food. In addition, 
our QAR demonstrates that humans (i.e., workers and visitors) are 
potential carriers of foodborne pathogens and can be a source of 
contamination of produce. Therefore, farm workers need training on the 
importance of health and hygiene. In addition, employees need training 
on subparts C through O that are applicable to the employee's job 
responsibilities and on how to recognize and prevent potential 
contamination problems (e.g., a leafy green vegetable contaminated with 
manure, contaminating the water supply during sample collection for 
testing, etc.) 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.
    (Comment 150) Several comments object to proposed subpart C based 
on the size of the farm or number of full-time employees.
    (Response) We have considered the burden to small businesses and 
provided sufficient flexibility within the final rule to be practicable 
for different sizes and types of businesses, including for small and 
very small businesses. See section IX.C of this document. We do not 
agree that additional flexibility should be incorporated by exempting 
farms from the training requirements based on the size of the business. 
Training farm workers is important regardless of the size of the farm.
    (Comment 151) Two commenters question the need for the provisions 
in subpart C and state that a farm should instead be responsible for 
developing its own training programs that are shown to meet specified 
regulatory outcomes.
    (Response) The requirements in part 112 do not preclude farmers or 
industry associations from developing training materials or programs 
uniquely suited to their commodities or operations; however, we have 
determined that the training must cover the specified topics in order 
to ensure that farm workers have sufficient training.
    (Comment 152) Some comments recommend that we develop a process or 
system whereby workers who are properly trained would receive a 
``training certificate'' or a ``food safety certificate,'' which 
commenters believe would be particularly useful for workers

[[Page 74419]]

who work on multiple farms during the year. These comments suggest that 
such certificates may be received (and updated) after undergoing 
training using an FDA-approved standardized curriculum or an equivalent 
curriculum. According to these comments, such a certificate could be 
valid for a harvest season or a calendar period, such as one year, and 
could also be valid for multiple crops of a similar nature, such as all 
deciduous tree fruits. Some comments state that a certificate should 
not obviate the need for training upon hire, at the beginning of each 
growing season and periodically thereafter, but could provide covered 
farms with a better sense of the food safety capacity of their 
workforce.
    (Response) We see the value of workers receiving a ``training 
certificate'' or a ``food safety certificate'' documenting the training 
they have received. However, at this time, we are not requiring use of 
such a program (either as a new requirement or to satisfy any of the 
requirements of this rule), nor are we able to develop such a system or 
recommend a specific certification process or certification body to 
enable such an approach. Note, under Sec.  112.30(b)(1), 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. We are willing to work with an organization that is 
interested in developing and implementing a training certification 
program, including through the PSA and SSA and using corresponding 
training materials.
    (Comment 153) Some comments urge the use of Web site(s) (or web-
based training) for educating employees about food safety and hygiene 
as a means to reduce the cost burden of training requirements, 
especially for smaller farms. One comment notes the advantages of using 
online resources, including that it can be continuously updated over 
time.
    (Response) Internet-accessible training materials are a convenient 
way for workers, supervisors, and other farm staff to obtain rapid 
access to training materials and other resources. We are considering 
whether and to what extent the Alliance courses can be made available 
online or offered as Internet-based training. At a minimum, we will 
make the standardized curriculum available online.
    (Comment 154) One comment (from a foreign government) requests that 
we provide training materials or guidelines to the foreign government 
in a timely manner so relevant parties (including manufacturers, 
exporters, and regulators) can understand and properly implement the 
rule.
    (Response) We are working to ensure the Alliance courses and 
training resources to be generated by the NCC and RC are consistent 
with the requirements of this rule. We intend to publish a notice of 
availability of these documents in the Federal Register, and our 
domestic and foreign stakeholders will be informed of and have access 
to these documents. We will partner with our foreign government 
counterparts as well as industry stakeholders to identify areas for 
outreach and technical cooperation to achieve greater understanding and 
implementation of the Produce Safety standards. In this regard, 
organizations such as the PSA, SSA, and JIFSAN can aid in providing 
appropriate qualification and training materials for foreign 
governments as well as training of foreign industry entities.

B. Qualification and Training for Personnel Who Handle (Contact) 
Covered Produce or Food-Contact Surfaces (Sec.  112.21)

    (Comment 155) Some comments suggest exceptions to proposed subpart 
C based on types of employees. Although many commenters believe all 
types of employees should be covered by the provisions, including 
temporary, part-time, seasonal, and contracted employees, some other 
commenters believe complying with proposed subpart C would be 
prohibitively difficult and, therefore, certain types of employees 
should be exempted. Comments state that requiring seasonal training for 
all employees, including long-term, non-seasonal workers, is 
unnecessary and wasteful. One commenter believes that training should 
not be required ``periodically'' but instead only for new hires, when 
rules are changed, or when problems are observed. Another comment is 
additionally concerned that, because the term ``season'' is not 
defined, the mandatory training provisions might be interpreted to 
require a separate training for each crop, some of which may have short 
planting-harvest cycles.
    (Response) We continue to believe that adequate and appropriate 
training of all 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. Therefore, we 
disagree that certain types of farm workers should be exempt from a 
requirement that they receive training. Rather, we agree the content of 
the required training can be tailored to the specific duties of the 
type of farm worker or supervisor. Under Sec.  112.21, all personnel 
(including temporary, part time, seasonal and contracted personnel) who 
handle (contact) covered produce or food-contact surfaces and their 
supervisors must receive training that is appropriate to the person's 
duties (Sec.  112.21(a)), and must have a combination of education, 
training, and experience to perform their assigned duties in a manner 
that ensures compliance with part 112 (Sec.  112.21(b)).
    With respect to the comments about when training should be 
conducted, 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. However, 
we acknowledge the concerns raised by commenters about our proposed 
requirement that training must be conducted at the beginning of each 
growing season, if applicable. We agree that requiring all personnel to 
receive training at the beginning of each growing season could be 
unduly burdensome for certain farms, such as those that grow multiple 
crops annually, grow crops with short harvest cycles, or grow certain 
types of year-round crops with no set growing season. Therefore, in 
lieu of the proposed requirement to train workers at the beginning of 
each growing season if applicable, we are revising the requirement to 
specify that periodic training must be conducted at least once 
annually. This requirement is in addition to the training that is 
conducted at the time of hiring. Periodic training can be conducted at 
a time that is appropriate, but must be conducted at least once 
annually. This allows farms to take into account such issues as the 
crop cycle, type and number of crops grown and harvested, and the 
timing when employee was hired and initially trained. As discussed in 
the 2013 proposed rule, periodic training serves to remind employees of 
the proper procedures including any changes in those procedures. Such 
updates may not need 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.
    (Comment 156) One comment asks us to recognize that ``education or 
experience'' can replace the need for specific training.
    (Response) As discussed in the 2013 proposed rule, the standards in 
subparts

[[Page 74420]]

C through O often involve action by farm personnel (e.g., assessment 
for animal intrusion, inspecting agricultural water system) that 
require specific knowledge, skills, and abilities, without which the 
standard cannot be properly achieved. Therefore, it is important those 
farm personnel have the training so they will have the necessary 
knowledge, skills, and abilities to perform their duties. In addition, 
experience at farming does not necessarily convey knowledge of food 
safety, particularly of microbial food safety hazards, and therefore 
specialized training is needed to address the specific concerns of on-
farm food safety. Consequently, we disagree with the suggestion that 
education or experience can serve as a substitute for appropriate 
training.
    (Comment 157) Some comments seek clarification on whether ``pick-
your-own'' farms would be required to provide training to customers who 
pick their own produce.
    (Response) We are establishing requirements for training of on-farm 
personnel. We are not establishing any requirements for training of 
visitors or customers at any farm, including at a ``pick-your-own'' 
farm. However, we note that this rule requires, in Sec.  112.33, that 
covered farms 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, and make toilet and hand-washing 
facilities accessible to visitors. As discussed in section XII of this 
document, for example, a ``pick-your-own'' farm could comply with these 
requirements by indicating the location of restrooms and hand-washing 
facilities that are accessible to visitors, and by clearly posting such 
information where it is likely to be seen and read by visitors at the 
beginning of their visit to the farm, such as near the entrance or a 
cash register of the farm.
    (Comment 158) One comment states people harvesting remnant crops 
following the main harvest for non-profit organizations (referred to as 
``gleaners''), often for donation to food banks, should not be subject 
to training requirements. Another comment states that in scenarios 
where a farm has completed its main harvest, and a third party 
purchases and harvests the remaining unharvested crop, it should be the 
responsibility of the remnant harvesting entity to ensure that their 
harvesters are appropriately trained.
    (Response) An operation that harvests crops but does not grow them, 
such as a ``gleaner'' operation or other remnant harvester operation, 
may meet the revised definition of ``farm'' as established in the PCHF 
regulation and as we are establishing it in this rule (see definition 
of ``farm'' in Sec.  112.3(c)). While we are not exempting operations 
that harvest remnant crops from the provisions of part 112, we believe 
that it is likely that most such operations (including those who do so 
for donation to food banks) will not be covered by this rule because 
they will have $25,000 or less in annual sales of produce or will be 
eligible for a qualified exemption. Specifically, in response to the 
comment about harvesting remnant crops, we expect those farms 
conducting the covered activities (harvesting of remnant crop and any 
subsequent packing or holding) to comply with the applicable 
requirements of the rule. Personnel employed by such entities must be 
trained appropriately.
    (Comment 159) One comment states that, when a farm contracts with 
another company for a contracted harvest crew, the company providing 
the harvest crew should be responsible for the initial, more 
comprehensive, food safety training, and the harvest crew should be 
made aware of food safety specifics at each farm at which they are 
harvesting, including standard operating procedures specific to the 
farm.
    (Response) Where a covered farm uses contracted harvest crews to 
harvest covered produce on the farm's behalf, the farm continues to be 
required to fulfill all relevant duties applicable under this rule. 
Thus, the farm is responsible for ensuring that the harvest crew has 
received required training. The farm may rely on the company that 
provides the harvest crew to provide or conduct the training, or the 
farm may provide or conduct the training. For example, if the harvest 
crew company provides training to workers who move from farm to farm 
under the employment of the harvest crew company, farms that employ 
such harvest crews may choose to rely on the harvest crew company to 
provide or conduct the training, request relevant certification from 
the harvest crew company, and maintain appropriate records to 
demonstrate compliance with the applicable training requirements.
    In addition, as discussed previously, an operation that harvests 
crops but does not grow them, such as a contract harvest crew company, 
may meet the revised definition of ``farm'' as established in the PCHF 
regulation and as we are establishing it in this rule (see definition 
of ``farm'' in Sec.  112.3(c)). Thus, if they are covered farms, 
contracted harvest crew companies also have duties to comply with this 
rule.
    (Comment 160) Some comments object to the ``education or 
experience'' clause in proposed Sec.  112.21(b). Comments argue the 
level of education or experience that would satisfy this requirement is 
unclear, and it would unnecessarily limit the pool of workers eligible 
to work on farms. One comment further notes a requirement for 
``experience'' would, by definition, preclude inexperienced workers 
from seeking such employment, although training could provide the 
knowledge necessary to perform tasks appropriately. A few comments 
recommend revising this provision to use the phrase ``must have the 
training, education or experience to perform the person's assigned 
duties'' whereas others recommend incorporating flexibility for 
personnel to be ``otherwise qualified through job experience'', in the 
same manner as allowed in 21 CFR parts 120 and 123 and in the proposed 
human preventive controls rule.
    (Response) We are revising this provision to require that personnel 
have ``a combination of education, training, and experience necessary 
to perform the person's assigned duties in a manner that ensures 
compliance with this part.'' This provides flexibility for how 
personnel are qualified to perform their duties. Depending on the job 
duties, this could include 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).
    (Comment 161) Several comments support making the trainings easily 
accessible and understood by all employees, regardless of native 
language or education level. One comment asks that we provide, via 
guidance, specific examples, such as pictograms, that can help 
facilitate understanding across language barriers.
    (Response) We recognize that the goals of training cannot be 
achieved if the persons receiving the training do not understand the 
training. 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, it may be necessary to use easily understood pictorials or 
graphics of important concepts. The PSA and SSA are developing training 
materials to be easily understood by farm workers of different 
languages, literacy, and educational levels by using pictorials or 
graphics of important concepts, along with offering the materials in 
multiple languages.

[[Page 74421]]

C. Training Personnel Who Conduct a Covered Activity (Sec.  112.22)

    We are revising Sec.  112.22(b)(1) to replace ``covered produce 
that should not be harvested'' with ``covered produce that must not be 
harvested'' to reflect the mandatory nature of the requirements in this 
rule and specifically, the requirements of Sec.  112.112.
    (Comment 162) Several comments request that we recognize existing 
food safety education and training programs that either meet or exceed 
the PSA materials, as an efficient way to gain compliance with subpart 
C. One comment asks that FDA allow existing educational programs that 
wish to gain equivalency with PSA materials to be able to modify their 
materials and program structure to fit the PSA learning objectives, 
rather than be required to adopt the exact format and materials 
developed by the PSA. The commenter further requests us to provide 
guidance on how existing programs can obtain equivalency with the PSA 
standardized curriculum, when it becomes available. Still other 
comments request that FDA develop approved curricula to meet the 
training requirements under subpart C. Yet another comment asks whether 
and what accreditation FDA would accept for training of on-farm 
trainers.
    (Response) See our response to Comment 3. The PSA and SSA training 
materials will include a standardized curriculum. FDA is working with 
the PSA and SSA to ensure that FDA will be able to recognize this 
curriculum, once developed, as adequate (see requirement under Sec.  
112.22(c)). We expect this standardized curriculum to be available in 
time for covered farms to be able to use it, as they work toward 
achieving compliance with the produce safety regulation. Under Sec.  
112.22(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 FDA. Accordingly, successful completion of training using 
the standardized curriculum by your farm personnel (at a minimum, by 
one supervisor or responsible party for your farm) is sufficient to 
satisfy the requirements of Sec.  112.22(c). Alternatively, at least 
one supervisor or responsible party for your farm must successfully 
complete training using any other training material or program, 
provided such training is at least equivalent to the standardized 
curriculum, and all of your other farm personnel must be trained in 
accordance with Sec.  112.22(a) and, as applicable, Sec.  112.22(b). We 
encourage trainers outside the PSA and SSA to evaluate their courses 
against the PSA and SSA 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 courses. We agree that existing programs 
can modify their training program structures and curriculum to ensure 
consistency with, and provide at least an equivalent level of 
instruction to, the standardized curriculum without necessarily 
adopting the PSA or SSA training structure or materials. We also intend 
to fund the development of certain alternate training programs for 
specific target audiences through cooperative agreements. The agency 
will work closely with the participants in those agreements and expects 
to recognize the training programs that are developed through these 
collaborations. We intend that the standardized curricula being 
developed by the Alliances and the alternate curricula to be developed 
through cooperative agreements are the only ones that will be 
officially recognized by the FDA. We emphasize, however, that official 
recognition by FDA is not required for training curricula to be ``at 
least equivalent to that received under standardized curriculum 
recognized as adequate by the Food and Drug Administration'' as stated 
in Sec.  112.22(c). Any training curricula that are at least equivalent 
to the officially recognized curriculum satisfy this requirement. We 
have no plans to establish an accreditation system for the training of 
on-farm trainers, although it is an area that is being explored through 
the PSA and SSA.
    (Comment 163) Some comments ask for clarification on the content of 
the food safety training based on the standardized curriculum 
recognized by FDA. One comment asks FDA to better define the elements 
of ``food hygiene and food safety'' that should be covered in 
comprehensive training, and offers suggestions on such elements.
    (Response) FDA concludes that the broad topic areas addressed in 
Sec.  112.22(a) are those minimum topic areas necessary to be covered 
during training for all employees who handle or contact covered 
produce. Training in the principles of food hygiene and food safety is 
a necessary component of such required training because it will provide 
an overall framework for job performance. We expect the standardized 
curriculum, when it becomes available, will provide information about 
the content to be covered under these minimum required topic areas, 
including with respect to principles of food hygiene and food safety.

D. Records Related to Personnel Qualifications and Training (Sec.  
112.30)

    (Comment 164) One comment states it is not reasonable for 
operations to be required to keep training records for personnel who 
received training at another operation or for contract workers (e.g., 
harvest crew, sanitation crew). This comment recommends revising 
proposed Sec.  112.30(b) to be limited to records of trainings 
performed or paid for by the operation, supplemented by additional 
records providing a rationale for personnel who did not receive such 
training at or by the operation.
    (Response) We are not making the requested change. A covered farm 
must ensure and keep records that document the required training 
received by personnel, regardless of whether the training is offered 
and the applicable records are generated by the farm or by another 
entity, such as the harvest crew company (see also our response to 
Comment 159). The records required under Sec.  112.30(b)(1) are 
intended to enable a covered farm to track the content and timing of 
training personnel have received, identify personnel and training 
topics for periodic updates, and identify personnel that have the 
necessary training for assignment to certain responsibilities; and to 
allow FDA to verify compliance with the rule's training requirements.

XII. Subpart D--Comments on Health and Hygiene

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

[[Page 74422]]

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

A. General Comments

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

B. Ill or Infected Persons (Sec.  112.31)

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

[[Page 74423]]

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

C. Personnel Hygienic Practices (Sec.  112.32)

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

[[Page 74424]]

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

D. Visitors (Sec.  112.33)

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

[[Page 74425]]

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

XIII. Subpart E--Comments on Agricultural Water

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

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

[[Page 74426]]

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

[[Page 74427]]

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

A. General Comments

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

[[Page 74428]]

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

[[Page 74429]]

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

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

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

[[Page 74430]]

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

[[Page 74431]]

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

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

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

[[Page 74432]]

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

[[Page 74433]]

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

[[Page 74434]]

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

D. Treatment of Agricultural Water (Sec.  112.43)

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

[[Page 74435]]

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

[[Page 74436]]

    FDA has analyzed the potential environmental impacts of the 
agricultural water standard in Chapter 4.2 of the EIS. As part of the 
analysis, FDA has determined that presently, there is no EPA-approved 
chemical treatment for contaminated water used to irrigate cropland 
(Ref. 128). FDA does not have specific information on the pesticides 
that might be submitted to EPA for registration for uses to control 
specific target organisms, such as pathogens, specifically in 
agricultural water applied to produce. However, as described in greater 
detail in Chapter 3.1 and 4.2 of the EIS, we agree that the most 
commonly used antimicrobials for microbial population reduction are 
chlorine chemicals, specifically sodium hypochlorite, calcium 
hypochlorite, gaseous chlorine and chlorine dioxide. It is anticipated 
that chlorine compounds would be among the preferred chemicals for 
which industry would be likely to seek FIFRA registration. FDA has 
considered the potential impacts of this rule on the environment and 
worker health as part of the EIS (Ref. 126). With respect to 
environmental concerns related to chemical treatment of agricultural 
water, we note that environmental and health-related risk assessments 
of pesticide products are conducted by EPA prior to their registration 
and use (see Comment 194).
    Should a covered farm choose to treat their agricultural water to 
ensure it meets the applicable requirements for its intended use, we 
expect any treatment that is used would be applied in accordance with 
all applicable federal, State, tribal, and local regulations.
    (Comment 196) Several comments discuss EPA's registration 
requirements related to pesticide use. Acknowledging our statement in 
the 2013 proposed rule that no EPA registrations currently exist under 
FIFRA for chemicals used in the treatment of irrigation water, comments 
express concern about the current lack of available EPA-approved 
antimicrobial treatments for irrigation water and the purported lack of 
an available EPA process by which such chemicals could be approved. 
Such comments state diverse concerns, including that: providing 
treatment of irrigation water as an alternative under the produce 
safety regulation may not be a viable option; the absence of available 
treatment methods may jeopardize the use of some agricultural water 
sources and could force some farms to stop irrigating crops and to 
suffer economic hardship; treating irrigation water without available 
registered options is illegal, in that the use of unapproved substances 
would violate both State and federal pesticide-use regulations; and, 
due to the lack of approved treatments, farms may treat water with 
unapproved methods that could lead to environmental and public health 
concerns. Another commenter recommends eliminating proposed Sec.  
112.43(a) because no approved treatment products for this use currently 
exist. Similarly, another commenter recommends that the water treatment 
provisions should not be implemented until a registry of approved water 
disinfection agents exists.
    Several comments also request that FDA work with EPA and other 
relevant agencies to provide clear direction to industry regarding 
acceptable and available water treatment options. One commenter 
believes that reliance on a process that is regulated by another 
government agency may create uncertainty for farms. This commenter 
recommends that FDA collaborate with EPA to: 1) Identify and make 
information available about currently-registered compounds and 2) 
establish a priority review process to ensure that farms have effective 
options available for the treatment of irrigation water prior to the 
compliance dates for the water requirements. One comment requests 
clarification on the approval that would be required to use an existing 
microbial pesticide to meet the requirement in Sec.  112.43.
    Other comments state that EPA-approved products for treating 
irrigation water are currently available. For example, one comment 
reports that the National Pesticide Information Retrieval System 
(NPIRS) database shows that nearly 90 federally-registered disinfectant 
products are available for uses in fruit or vegetable wash water or 
processing water, and that other products are labeled for use in 
treatment of agricultural and irrigation water systems, including drip 
irrigation systems. Another comment provides an example of a treatment, 
asserting that it is registered with EPA for use in all types of 
irrigation water systems, including in USDA-inspected fruit and 
vegetable wash water operations.
    (Response) We are retaining Sec.  112.43 with some modifications, 
as explained under Comment 194. This provision applies to agricultural 
water (as defined in Sec.  112.3) that is used in growing, harvesting, 
packing, and holding activities related to covered produce. We 
consulted with EPA on currently available options for treating 
agricultural water in a manner consistent with Sec.  112.43.
    At this time, no EPA registrations exist for chemical substances 
(classified by EPA as ``pesticide products'') for antimicrobial 
treatment of agricultural water used during the growing of crops (Ref. 
128). However, as discussed in Chapter 4.2 of the EIS, EPA maintains a 
list of ``Antimicrobial Products Registered with the EPA as 
Sterilizers.'' Each of these products received approval under FIFRA as 
amended in 1996 (40 CFR parts 152, 156, and 158). Like all registered 
pesticide products, registrations for antimicrobial products are 
specific to the use that was considered as part of the registration 
process, and thus the products may be legally used for the specified 
registered use only. Among compounds on the list of EPA's registered 
antimicrobial products as sterilizers are certain registered 
antimicrobial washes, which are authorized for use during postharvest 
fruit and vegetable washing. These products can be used to treat 
agricultural water that is used to wash produce postharvest, such as in 
packing houses. However, because these antimicrobial products are not 
authorized by EPA for use on agricultural fields, they cannot be used 
to treat irrigation water that is applied prior to harvest. Also on 
this list are certain registered antimicrobial products for use in the 
treatment of irrigation water systems or irrigation ponds to control 
bacterial and algae growth. However, because these antimicrobial 
products are not authorized by EPA for use to control human pathogens 
or indicator organisms, they cannot be used to treat irrigation water 
to comply with the microbial quality criteria in Sec.  112.44(b).
    We anticipate that the delayed compliance dates for certain water 
quality provisions in this rule (see our discussion of compliance dates 
in section XIII.K of this document) provide adequate time to address 
the current lack of EPA-registered chemical treatments for agricultural 
water used in growing activities. We will work with EPA, as 
appropriate, regarding registration of pesticide products for treatment 
of agricultural water during growing. In response to comments 
requesting priority review for registration of irrigation water 
chemicals, we note that EPA has statutory timelines under which it must 
consider registration applications (i.e., 15 to 21 months for a ``new 
food use'' of a compound). Information about EPA's pesticide 
registration process is available on its Web site at http://www2.epa.gov/pesticides (Ref. 129), and is also explained in chapters 
3.8 and 4.2 of the EIS.
    Section 112.43 also allows for non-chemical suitable methods for 
treatment

[[Page 74437]]

of agricultural water. Unlike pesticide products, pest control devices 
that work by physical means and are classified by EPA as ``pesticide 
devices'' do not require registration by EPA under FIFRA. According to 
EPA, FIFRA defines a device as any instrument or contrivance (other 
than a firearm) that is intended for trapping, destroying, repelling, 
or mitigating any pest or any other form of plant or animal life (other 
than man and other than bacteria, virus, or other microorganism on or 
in living man or other living animals); but not including equipment 
used for the application of pesticides when sold separately therefrom 
(Ref. 130). (Note that ``pesticide devices'' do not include medical 
devices, which are regulated by FDA.) Although not required to be 
registered, pesticide devices are regulated by EPA in that false or 
misleading claims cannot be made about the effectiveness of the device. 
Physical treatment of agricultural water, including using a pesticide 
device(s), or by any other suitable treatment method can be employed 
provided the method is effective to make the water safe and of adequate 
sanitary quality for its intended use and/or meet the relevant 
microbial quality criteria in Sec.  112.44, as applicable. In addition, 
the treatment must be delivered and monitored in a manner and with a 
frequency adequate to ensure that the treated water is consistently 
safe and of adequate sanitary quality for its intended use and/or 
consistently meets the relevant microbial quality criteria in Sec.  
112.44, as applicable, as required under final Sec.  112.43(a)(2) and 
(b). Examples of pesticide devices used to treat water include filter 
units, ultraviolet light units, and ozonator units. Information about 
EPA's regulation of pesticide devices is available on its Web site 
(Ref. 130), and we advise you to consult EPA for information about 
appropriate use of pesticide devices. Note also that some States 
require registration of pesticide devices, and we refer you to the 
appropriate State pesticide regulatory agency for more information on a 
particular State's requirements related to pest control devices (Ref. 
131). Information about EPA's Tribal Pesticide Programs is available on 
EPA's Web site at: http://www2.epa.gov/pesticide-advisory-committees-and-regulatory-partners/tribal-pesticide-programs (Ref. 132). In 
addition, information regarding current EPA-registered pesticide 
products is available on EPA's Web site at: http://iaspub.epa.gov/apex/pesticides/f?p=PPLS:1 (Ref. 133).
    With respect to environmental concerns related to chemical 
treatment of agricultural water, we note that environmental and health-
related risk assessments of pesticide products are conducted by EPA 
prior to their registration and use (see Comment 194).
    (Comment 197) One comment expresses concern that adding an 
antimicrobial treatment to irrigation water would be considered a point 
source discharge of a pollutant, requiring farms to obtain a National 
Pollution Discharge Elimination System (NPDES) permit, and that 
implementation of agricultural water treatment in compliance with Sec.  
112.43 would expose farms to liability under the Clean Water Act (CWA), 
including a potential citizen suit. The commenter also maintains that 
requiring farms to treat surface irrigation water with antimicrobial 
pesticides could subject farms to liability under the ESA or potential 
increased scrutiny regarding their effects on anadromous (i.e., 
ascending rivers from the sea for breeding) species. The commenter 
notes that the 2013 proposed rule did not indicate whether FDA would 
conduct ESA consultation, and recommends that we outline our intentions 
with respect to ESA compliance and the potential impact of 
implementation of the produce safety regulation.
    (Response) We have evaluated the potential effects of the produce 
safety regulation on the human environment in the United States. Our 
evaluation and conclusions based on that evaluation are described in 
the final EIS (Ref. 126). We refer you to that document for a detailed 
discussion of the potential environmental effects of the produce safety 
regulation, including those associated with the standards for 
agricultural water in subpart E of part 112. With respect to the CWA, 
only a portion of agricultural facilities are considered point source 
dischargers that would require NPDES permits. This form of regulatory 
oversight is discussed in Chapter 3.1.2 of the EIS. The provisions of 
the produce safety regulation do not authorize covered farms to violate 
existing laws and regulations, including the CWA. This rule also does 
not affect the status of any farm that is currently subject to NPDES 
permits.
    We also considered the effects of the produce safety regulation on 
threatened and endangered species. In the supplemental notice, we 
proposed a new provision Sec.  112.84 that explicitly states that part 
112 does not authorize or require covered farms to take actions that 
would constitute the ``taking'' of threatened or endangered species in 
violation of the ESA, or require covered farms to take measures to 
exclude animals from outdoor growing areas, or destroy animal habitat 
or otherwise clear farm borders around outdoor growing areas or 
drainages. We are finalizing this provision, as proposed. FDA has 
concluded informal consultation with FWS under the ESA. We have also 
been involved in conversations with National Marine Fisheries Service 
regarding our ESA obligations. See (Ref. 134) (Ref. 135) for additional 
information.
    (Comment 198) Several commenters discuss the interface between 
proposed Sec.  112.43 and State or regional policies related to water 
or water treatment, such as permit requirements. One comment notes 
that, in most States, application of pesticides to any surface waters 
(including irrigation waters) is subject to permit requirements. 
Another comment mentions that, if a farm installs a chlorination 
facility in order to comply with the produce safety regulation, then 
the applicable State and/or Regional Water Board might issue a permit 
to that farm to make sure that any disinfection by-products running out 
of the farm's fields do not damage the environment or water quality. 
This comment asserts that the issuing of such permits could be a 
significant burden on farms and on State and Regional Water Boards. One 
comment mentions that water treatment products used in California must 
be registered with the California EPA's Department of Pesticide 
Regulation (CDPR). This comment speculates that if the produce safety 
regulation results in significant increase in use of pesticides to 
treat water, that the CDPR's requirement to register treatment products 
may result in time delays and antimicrobial products may become less 
available.
    (Response) As noted in response to Comment 194, the produce safety 
regulation does not require covered farms to consider treating 
agricultural water as an immediate first step where the water is not 
safe or of adequate sanitary quality for its intended use and/or does 
not meet the microbial quality criteria in Sec.  112.44. Rather, 
covered farms have a range of viable options to consider based on 
practices and conditions specific to the farm, treatment of water being 
only one such option. When a covered farm does choose to treat water to 
ensure its safety for its intended use, we are providing for the 
treatment of water using any effective treatment method (such as 
physical treatment, including using a pesticide device as defined by 
EPA; EPA-registered antimicrobial pesticide product; or other suitable 
method).

[[Page 74438]]

Nothing in the regulations in part 112 requires or authorizes farms to 
take measures in conflict with existing federal, State, or local 
regulations related to water treatment. We also considered the 
environmental impacts associated with the standards for agricultural 
water, as discussed in the final EIS (Ref. 126).
    When agricultural water is treated to ensure that it is safe and of 
adequate sanitary quality for its intended use, we expect any treatment 
that is used would be applied in accordance with all applicable 
federal, State, tribal, or local regulations. For example, any 
pesticide chemicals used in the treatment of water require EPA 
registration before they can be lawfully used.
    (Comment 199) Several comments request that we provide additional 
clarification, instruction, and/or examples regarding how farms can 
treat water in order to comply with proposed Sec.  112.43. One 
commenter claims that proposed Sec.  112.43 is vague, in that it 
outlines neither the level of microbial reduction that must be achieved 
nor the microbial standard that must be met. Several comments request 
that FDA clarify which economical water treatments exist that might be 
used to bring water into compliance with levels established in the 
rule, and ask that we give examples of such treatments, provided that 
they do not conflict with other federal or State regulations. Other 
commenters maintain that farms need agricultural water treatment 
alternatives to chlorine, and request that FDA clarify which water 
treatments beyond chlorination are available to comply with proposed 
Sec.  112.43. Another comment asks that, if FDA chooses to provide 
examples of water treatment methods, that we cite methods, such as 
hydrogen peroxide and UV treatment, which minimize the potential for 
environmental and public health impacts. Relatedly, another commenter 
contends that FDA should explicitly recommend methods of water 
treatment that do not involve chemicals. Although supporting the 
requirement in proposed Sec.  112.43(c)(2) that any treatment of 
agricultural water must be monitored, some comments seek additional 
specification, such as a defined interval for monitoring, the resulting 
water quality, and the point of monitoring (either at the place where 
the treatment is added or at the point of use of water).
    (Response) If a covered farm chooses to treat agricultural water to 
make the water safe and of adequate sanitary quality for its intended 
use and/or to meet the relevant microbial quality criteria in Sec.  
112.44, Sec.  112.43 requires that the treatment that is applied, 
regardless of the specific method employed, must be effective to make 
the water safe and of adequate sanitary quality for its intended use 
and/or meet the relevant microbial quality criteria in Sec.  112.44, as 
applicable. The required quality is dependent on the intended use of 
the agricultural water, with specific microbial quality criteria 
established in Sec.  112.44(a) for certain specified uses; in Sec.  
112.44(b) for use during growing of produce (other than sprouts) using 
a direct application method; and in Sec.  112.41, generally.
    The specific level and frequency of treatment, the point at which 
treatment should be applied, and the intervals for monitoring 
treatments required under Sec.  112.43 also vary, and are dependent, in 
part, on the method of treatment and the farm's operations, including 
its water source, intended use of the water source, and the water 
distribution system. As discussed in the 2013 proposed rule, an example 
of an effective monitoring program for use of a chemical treatment 
method 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, adequate monitoring of water treated with 
hypochlorite in an orange postharvest wash must 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. 136) (Ref. 137) (Ref. 138) (Ref. 
139). 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 at 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 of adequate sanitary quality for its intended use and/or meets 
the relevant microbial quality criteria in Sec.  112.44, as applicable. 
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 treatment process (Ref. 136). As a 
verification that the treatment process, monitored in accordance with 
Sec.  112.43(b), is effective in achieving a certain microbial quality 
requirement (e.g., no detectable generic E. coli in 100 mL of water), 
you may choose to perform periodic microbiological analysis of the 
treated agricultural water. Although not a requirement, 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 will consider discussing these issues further 
in the Produce Safety Regulation implementation guidance to be issued 
in the near term.
    (Comment 200) Several comments focus on the treatment of harvest 
and postharvest water. For example, one comment requests clarification 
on whether the proposed standard would require water for dump tanks to 
have an added disinfectant, whereas another commenter recommends that 
farms should use, as appropriate, antimicrobials in fruit and vegetable 
wash water for pathogen reduction. Comments also provide other 
suggestions, including: (1) That farms with more than $5 million in 
gross sales should be required to include a disinfectant in their wash 
water, if such farms are immersing in dump tanks either leafy greens or 
produce that can take up water through a temperature differential; (2) 
that farms should be permitted to continue their current use of a 
chlorine-free product to treat water in a dunk or flume, which in the 
commenter's view renders the proposed water standards excessive; and 
(3) that the provisions should address the use or validation of 
compounds authorized for use.
    (Response) As noted in response to Comment 194, the produce safety 
regulation does not require covered farms to consider treating 
agricultural water as an immediate first step where the water is not 
safe or of adequate sanitary quality for its intended use and/or does 
not meet the relevant microbial quality criteria in Sec.  112.44, as 
applicable. Rather, covered farms have a range of viable options to 
consider based on practices and conditions specific to the farm, 
treatment of water being only one such option. This includes 
agricultural water used during or after harvest. Under Sec.  
112.44(a)(2), agricultural water must contain no detectable generic E. 
coli per 100 mL when it is 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. This microbial 
quality criterion, therefore, applies to wash

[[Page 74439]]

water in dump tanks, flumes, or wash tanks used to wash covered 
produce. Where water does not meet this microbial quality requirement, 
farms have different options to ensure the water is safe to use for 
this purpose. A covered farm may choose to add an EPA-approved 
disinfectant to the wash water in dump tanks to ensure the water 
contains no detectable E. coli and is safe and of adequate sanitary 
quality for its intended use. However, treatment of water is not the 
only option. In addition to treatment, another option available to 
farms includes re-inspecting the entire affected system, identifying 
conditions that are reasonably likely to introduce hazards, making 
changes to the system and re-testing the water successfully (Sec.  
112.45(a)(1)) or using water from a different source that does meet the 
microbial quality requirement.
    The commenter who suggested a sales-based requirement for use of a 
disinfectant in wash water did not provide a rationale for such a 
requirement. We are establishing a microbial quality requirement for 
such water in Sec.  112.44(a), and options for taking action when water 
does not meet that standard in Sec.  112.45(a). We are not requiring 
any farms to treat wash water regardless of whether it meets the 
quality requirement, nor are we requiring only certain farms to do so 
based on their sales or the type of commodity they produce.
    With respect to comments asking us to address the use or validation 
of compounds authorized for use, we note that although some 
antimicrobial substances are regulated by FDA, most antimicrobial 
substances that might be used by covered farms in agricultural water 
are regulated by the EPA. A decision tree regarding whether an 
antimicrobial substance would be regulated by the EPA or the FDA is 
available at: http://www.fda.gov/Food/IngredientsPackagingLabeling/PackagingFCS/RegulatoryAuthorityAntimicrobialSubstances/default.htm 
(Ref. 140). See also the discussion of available antimicrobial products 
registered with EPA as sterilizers in Comment 194.
    (Comment 201) Several commenters assert that proposed Sec.  112.43 
would create a preference for the use of antimicrobial pesticides as an 
appropriate water treatment method; these comments point out that the 
proposed provision provides only an example of using an EPA-registered 
antimicrobial pesticide product to treat water, without offering any 
additional examples. Another commenter observes that the proposed 
provision appears flexible, but that the related commentary in the 
preamble only discusses chemical treatment of water. This commenter 
also notes that various non-chemical treatment methods, such as 
mechanical or physical methods (e.g., filtration) are currently being 
explored.
    (Response) As noted in response to Comment 194, when a covered farm 
chooses to treat its agricultural water to ensure it is safe and of 
adequate sanitary quality for its intended use and/or meets the 
relevant microbial quality criteria in Sec.  112.44, as applicable, we 
are providing for the treatment of water using any effective treatment 
method (such as physical treatment, including using a pesticide device 
as defined by EPA; EPA-registered antimicrobial pesticide product; or 
other suitable method). We recognize that methods other than chemical 
treatment are either available or being explored for the treatment of 
agricultural water, for example, pesticide devices (such as filter 
units, ultraviolet light units, and ozonator units), reverse osmosis, 
and solar methods (Ref. 141). We also agree that water treatment 
options should not be, and are not, limited to chemical methods. As 
part of the EIS, FDA has considered a range of management decisions 
that a farm might take to be in compliance with the water quality 
requirements. These management decisions are outlined in Table 2.1-2 of 
the EIS and discussed in further detail in Chapter 4.2 of the EIS (Ref. 
126). To make clear that water treatment options are not limited to 
chemical methods, we are revising Sec.  112.43(a) to include additional 
examples besides chemical treatment methods.
    (Comment 202) Some comments state that, under the NOP standards, 
only certain specified substances may be used as disinfectants and 
sanitizers in organic crop production (provided that the use of such 
substances does not contribute to contamination of crops, soil, or 
water), and that currently no pesticide chemicals are allowed under the 
NOP that organic farmers would be able to use to treat water. 
Similarly, a trade organization comments that they are unaware of any 
antimicrobial pesticide that would be effective, allowed for use under 
the NOP, and allowed for use according to its label. A State department 
of agriculture states that a surface water irrigator treating water 
with antimicrobial pesticides could result in organic producers located 
downstream to use water that has been treated, which could cause them 
to have their organic certifications revoked. Another comment expresses 
concern that water treatment chemicals will damage the microbiology of 
the soil, thus compromising the ability of organic farmers, who depend 
on the soil biology ecosystem, to grow safe and healthy food.
    (Response) Throughout the development of the produce safety 
regulation, we have been working with USDA on a number of issues, 
including on whether and how this rule affects compliance with the NOP 
regulations. Compliance with the provisions of this rule does not 
preclude compliance with the requirements for organic certification in 
7 CFR part 205. As discussed previously, this rule does not require 
covered farms to consider treating agricultural water as an immediate 
first step where the water is not safe or of adequate sanitary quality 
for its intended use and/or does not meet the relevant microbial 
quality criteria in Sec.  112.44, as applicable. Rather, covered farms 
have a range of viable options to consider based on practices and 
conditions specific to the farm, treatment of water being only one such 
option. Thus, this rule does not require organic farms to use a 
substance that is prohibited in organic production.
    We understand that substances which are prohibited in organic 
production are described in 7 CFR 205.105. We advise you to consult 
with the NOP for additional information related to concerns about 
downstream effects of chemical treatment of water. In addition, as 
discussed previously, current options for EPA-registered pesticide 
chemicals for use in agricultural water are limited for all produce 
production, including organic produce. However, non-chemical water 
treatment options (such as filter units, ultraviolet light units, 
ozonator units, reverse osmosis, and solar methods) are either 
currently available or being explored, and such treatments may be used 
in compliance with Sec.  112.43. In addition, options other than 
treating agricultural water are also available under this rule for 
organic farms, just as for all other covered farms. See also our 
responses to Comment 194 and Comment 196.
    FDA has acknowledged in Chapter 4.2 of the EIS that certified 
organic farms are restricted to pesticides approved on the National 
List of Allowed and Prohibited Substances. However, FDA has determined 
that sustained, long-term water treatment may not be required because 
the added flexibility to account for microbial die-off and/or removal 
may be as simple as allowing sufficient time between final application 
of irrigation water and harvest. Certified organic farms will have 
sufficient flexibility to choose management decisions that allow them 
to retain their certification, including non-chemical

[[Page 74440]]

water treatments, postharvest options with and without chemicals, using 
alternative water sources and others as discussed in further detail in 
Chapter 4.2 of the EIS. The EIS also considers impacts of water quality 
criteria established in this rule on various resources, including soils 
(Ref. 126).
    (Comment 203) Some comments discuss the costs associated with 
treating water under proposed Sec.  112.43. Comments assert that some 
irrigation districts, municipalities, and farms lack the necessary 
infrastructure or financial resources to build such infrastructure. An 
additional comment states that increased use of antimicrobials in 
postharvest water will increase farm operating costs, and could lead to 
capital costs to mitigate increased amounts of contaminated waste water 
discharges.
    (Response) See our responses to Comment 194, Comment 195, Comment 
200, and Comment 201. We also recognize that covered farms will need 
time to consider the various options, and may need some adjustments to 
their existing practices or operations, to comply with the water 
provisions in this rule. Therefore, for covered activities involving 
covered produce (except sprouts), we are providing extended compliance 
periods for certain water provisions, as explained in section XIII.K of 
this document. We also intend to work with our State, tribal, and local 
partners and target our education and technical assistance efforts to 
smaller farms to help farms meet the requirements of the rule.
    With respect to the comment about increased costs, we estimate 
costs of antimicrobial use and related capital investments in our RIA. 
See the final RIA for a discussion of costs (Ref. 142).
    (Comment 204) One comment asks that we clarify that agricultural 
water should not be treated under Sec.  112.43 if such treatment would 
conflict with applicable laws.
    (Response) There is nothing in Sec.  112.43, specifically, or in 
part 112, generally, that requires or authorizes violations of other 
applicable laws. Should a covered farm choose to treat their 
agricultural water to ensure it meets the applicable requirements for 
its intended use, we expect any treatment that is used would be applied 
in accordance with all applicable federal, State, tribal, and local 
regulations.

E. Microbial Quality Criterion for Agricultural Water Used for Certain 
Specified Purposes (Sec.  112.44(a)) and Corresponding Corrective 
Measures (Sec.  112.45(a))

    (Comment 205) Some comments support the applicability of the 
microbial quality criterion in proposed Sec.  112.44(a) (i.e., no 
detectable E. coli) for uses of water specified under this provision. 
Some comments also state that water used during harvest, packing, and 
holding activities should be tested on a more frequent basis than other 
water used for agricultural purposes, and request FDA to provide 
guidance on the specifics of a sampling plan.
    (Response) We are finalizing proposed Sec.  112.44(a), such that 
the no detectable E. coli requirement applies to agricultural water 
that is used for purposes specified in that section. We are deleting 
proposed Sec.  112.44(a)(3) because we received comments indicating 
that this reference to treated agricultural teas in subpart E was 
confusing (see Comment 270 and Comment 271). We have amended Sec.  
112.51(a) and (b) in subpart F, and the definition of ``agricultural 
tea'' in Sec.  112.3(c), to clarify the requirements applicable to 
water used to make an agricultural tea.
    We address testing frequency requirements in Comment 224. In 
addition, we refer you to the discussion under Comment 180 and Comment 
181, where we explain the requirements for corrective measures that 
must be taken, and the timing for when such corrective measures must be 
taken, in accordance with Sec.  112.45(a), when your agricultural water 
does not meet the microbial quality criterion in Sec.  112.44(a) for 
those specified purposes.
    In the supplemental notice, we did not propose specific testing 
frequency requirements applicable to untreated surface water that is 
used for the purposes in Sec.  112.44(a). Instead, we proposed that you 
must test the quality of each source of the untreated surface water 
with an adequate frequency to provide reasonable assurances that the 
water meets the required microbial standard and that you must have 
adequate scientific data or information to support your testing 
frequency (proposed Sec.  112.45(d)). We also noted that although we 
were not restricting use of untreated surface water solely to growing 
activities (e.g., irrigation, crop protection sprays), we anticipated 
that the primary use of untreated surface water would be during growing 
activities. Thus, in the supplemental notice we did not specifically 
prohibit a farm from using untreated surface water for any purpose 
described in Sec.  112.44(a), provided that the water meets the no 
detectable E. coli standard for those purposes. We asked for comment on 
the prevalence of use of untreated surface water for the purposes 
listed under Sec.  112.44(a), and on an appropriate approach(es) to 
sampling and testing of untreated surface water intended for such uses. 
We also asked for comment on whether we should require treatment of 
surface water sources used for the purposes specified in Sec.  
112.44(a), rather than provide for a testing scheme, if the latter is 
not practical (79 FR 58434 at 58454).
    Some comments that responded to this request ask for clarification 
on what would be an adequate frequency or for guidance on an 
appropriate sampling plan. We continue to find it challenging to 
establish a generally applicable sampling scheme or frequency that 
would provide sufficient confidence that any source of untreated 
surface water, given the inherent variability associated with such 
sources, will consistently meet the no detectable E. coli microbial 
water quality criterion in proposed Sec.  112.44(a). Moreover, none of 
the comments explicitly recommended or supported retaining this testing 
requirement as a means to allow use of untreated surface water for the 
purposes in 112.44(a). Under the Surface Water Treatment Rule (40 CFR 
141.70-141.75), EPA requires public water systems to treat surface 
water or ground water sources under the direct influence of surface 
water to meet the requirements of the Safe Drinking Water Act (SDWA) 
(42 U.S.C. 300f et seq.). The intended uses listed in Sec.  112.44(a) 
have high potential to serve as a vehicle of fecal contamination 
because if fecal contamination is present (along with the corresponding 
potential for pathogen presence), it is reasonably likely it could be 
transferred directly to covered produce through direct or indirect (via 
food-contact surfaces) contact with the agricultural water. Considering 
this, as well as the inherent variability of the quality of untreated 
surface water sources; the absence of an identifiable, appropriate 
testing and sampling scheme to ensure the safe use of such untreated 
surface water for the purposes of Sec.  112.44(a); and the lack of 
comments persuading us to retain proposed Sec.  112.45(d), we are 
eliminating proposed Sec.  112.45(d) from subpart E and adding a 
prohibition in Sec.  112.44(a) on using untreated surface water for any 
of the purposes identified in that section.
    (Comment 206) One comment recommends that we establish less 
protective water quality requirements than those in proposed Sec.  
112.44(a) and

[[Page 74441]]

Sec.  112.44(c) that would be applicable to produce commodities that 
may be cooked or that are often cooked, and that we establish for such 
commodities a labeling requirement similar to ``Safe Handling'' 
labeling instructions for consumers that appear on meat products.
    (Response) We do not agree that such an approach would 
appropriately minimize the risk of serious adverse health consequences 
or death from consumption of contaminated produce. We believe the 
provisions in Sec. Sec.  112.2(a) and 112.2(b) sufficiently address the 
circumstances where produce is either rarely consumed raw or receives 
commercial processing to adequately reduce pathogens. For produce that 
is not ``rarely consumed raw'' or receives commercial processing to 
adequately reduce pathogens, we do not believe that less protective 
water requirements along with labeling instructions would be 
appropriately protective of public health or fulfill our FSMA mandate 
to establish science-based minimum standards for the safe production 
and harvesting of produce that minimize the risk of serious adverse 
health consequences or death. It is unclear how we could determine 
appropriate microbial criteria for such a ``less protective'' set of 
microbial water standards. It is also not clear that consumers would 
always cook such produce even if it were labeled with instructions that 
it should only be consumed after cooking or that consumers would 
understand why there were cooking instructions on a product that is 
often consumed uncooked.
    (Comment 207) Some comments suggest the microbial quality 
requirement in proposed Sec.  112.44(a) should apply to postharvest 
activities only.
    (Response) As discussed in the QAR, water used for the purposes 
listed in Sec.  112.44(a) has high potential to serve as a vehicle of 
fecal contamination because if fecal contamination is present (along 
with the corresponding potential for pathogen presence), it is 
reasonably likely it could be transferred directly to covered produce 
through direct or indirect (via food-contact surfaces) contact with the 
agricultural water. We explained our rationale for subjecting the 
intended uses of agricultural water listed in Sec.  112.44(a) to the 
stringent zero detectable E. coli microbial quality standard in the 
2013 proposed rule (see 78 FR 3504 at 3568). Therefore, we disagree 
with the commenters' suggestion that the microbial quality criterion in 
Sec.  112.44(a) should be limited to postharvest uses only (See also 
discussion in section XIV.A.1 of this document).
    (Comment 208) One comment points out that under the proposed 
provisions of part 112, on-farm postharvest handling of produce (such 
as packing) grown on the farm or other farms under the same ownership 
would be required to comply with the proposed Sec.  112.44(a) 
requirement to test water used for the listed purposes to ensure there 
is no detectable generic E. coli; but that the same activities, when 
subject to proposed part 117 (e.g., when the produce is packed off-
farm, or on-farm packing of produce from a farm under separate 
ownership) would not be subject to specific provisions requiring 
testing of such water.
    (Response) First, we note that there is no requirement to test 
water from certain types of public water systems used for the purposes 
listed in Sec.  112.44(a), nor is there any requirement to test water 
treated in accordance with Sec.  112.43 used for the same purposes (see 
Sec.  112.46(a)). See Comment 222. In addition, we are prohibiting use 
of untreated surface water for these purposes (see Sec.  112.44(a)), 
which means that only untreated ground water must be tested when used 
for these purposes (see Sec.  112.46(c)).
    Second, as discussed in section IX.B. and in the supplemental 
notice, we have revised the definition of ``farm'' so that farms that 
pack or hold produce RACs that are grown on a farm that is under 
different ownership would no longer necessarily be ``farm mixed-type 
facilities'' subject to the requirements of the PCHF regulation. 
Rather, packing or holding others' produce RACs on a covered farm will 
be subject to this rule unless the farm or the produce is otherwise 
exempt or not covered. Thus, there is no longer a difference in what 
requirements will apply to testing water used in on-farm postharvest 
handling of produce based on where the produce was grown. Moreover, we 
are also revising the definition of ``farm'' to include certain 
operations (Secondary Activities Farms) devoted to harvesting, packing, 
and/or holding of RACs, provided that the Primary Production Farm(s) 
that grow or raise the majority of the RACs harvested, packed, and/or 
held by the Secondary Activities Farm own, or jointly own, a majority 
interest in the Secondary Activities Farm. Thus, farm-owned cooperative 
packing houses, for example, will be considered Secondary Activities 
Farms, and water used in their postharvest handling of produce will be 
subject to this rule unless the farm or the produce is otherwise exempt 
or not covered.
    This rule does not apply to activities of a facility subject to 
section 418 of the FD&C Act. Such activities are addressed in the final 
human preventive controls rule and the final animal preventive controls 
rule (80 FR 55908 and 80 FR 56170, respectively).

F. Microbial Quality Criteria for Agricultural Water Used for Direct 
Application During Growing Activities of Produce (Other Than Sprouts) 
(Sec.  112.44(b) and Corresponding Corrective Measures (Sec.  
112.45(b))

1. Microbial Quality Criteria (Sec.  112.44(b))
    (Comment 209) Several comments assert that the use of EPA's 
Recreational Water Quality Criteria (RWQC) is inappropriate or 
insufficient for use in setting the microbial quality standard for 
agricultural water, as established under proposed Sec.  112.44(c). 
Comments express various concerns, including that: (1) FDA has not 
established a correlation between the RWQC and food safety and applying 
recreational water standards to irrigation water does not meet the 
statutory obligation to establish science-based standards for food 
safety; (2) the RWQC were developed more than two decades ago and do 
not reflect current science; (3) FDA has not provided sufficient 
explanation for how the RWQC would serve to minimize risk of known or 
reasonably foreseeable hazards, and that FDA, itself, acknowledges the 
limitations of using the RWQC; (4) the RWQC are likely appropriate for 
some, but not all, crops; and (5) the RWQC may not be achievable in 
areas of the country that use surface water for irrigation. These 
comments recommend that any microbial quality standard established in a 
final rule should be based on data that are specific to produce safety 
and agricultural water. In contrast, some comments support the use of 
RWQC in developing the microbial quality criteria in proposed Sec.  
112.44(c).
    (Response) We disagree with the assertion that the use of the 
science underlying the RWQC is inappropriate for informing the 
development of microbial quality criteria for agricultural water used 
in direct application during growing of produce (other than sprouts), 
which are now established in final Sec.  112.44(b). We agree that the 
RWQC (which are based on data collected from recreational waters), in 
and of themselves, do not sufficiently reflect the circumstances 
associated with agricultural water used in produce production. However, 
we are not simply applying the RWQC as the safety standard for 
agricultural water. Rather,

[[Page 74442]]

as discussed in the supplemental notice, we find that the science 
underlying the RWQC provides a starting point for quantitative 
microbial criteria that are generally applicable to minimize the risk 
of known or reasonably foreseeable hazards associated with the use of 
agricultural water on produce (other than sprouts) during growing using 
a direct water application method. The RWQC, which have been updated in 
2012, are based on several recent epidemiological studies and use a 
broader definition of illness to recognize that gastrointestinal 
symptoms may occur without a fever (Ref. 100). Among other evidence, 
EPA considered the latest research and epidemiological data that 
demonstrate a link between fecal contamination in recreational waters 
and illness, and characterizes the rate of illness based on the 
epidemiological data. Using those data, the EPA criteria demonstrate 
the microbial threshold at which an exceedance of the threshold 
increases illness occurrence to protect primary contact recreation 
where immersion and incidental ingestion are likely (Ref. 100). In 
addition, the EPA analysis does not distinguish the illness rates 
between different bodies of water (i.e., marine or fresh) due to 
incidental ingestion. Overall, we find the scientific rigor underlying 
the RWQC to be sufficient for us to rely on to inform our thinking on 
agricultural water used in produce production, which is also consumed 
via incidental ingestion. We described the rationale for our use of the 
science underlying the RWQC and our thinking on its relevance to 
agricultural water in a reference memorandum that accompanied the 
supplemental notice, and we reiterate those conclusions here (Ref. 44).
    In the supplemental notice, we acknowledged that there are 
different ways to determine STV, including through sample-based 
empirical estimation and model-based calculation, and requested comment 
on whether there is a specific statistical method(s) that we should 
either require or recommend be used for the derivation of GM and/or STV 
values (79 FR 58434 at 58453). We did not receive comments recommending 
any specific method(s) for calculation. On further evaluation, we find 
a parametric estimation method based on the lognormal distribution to 
be appropriate for deriving the STV for purposes of determining the 
microbial water quality criteria and any necessary follow-up measures 
specified in Sec. Sec.  112.44(b) and 112.45(b)(1), respectively. 
Unlike empirical methods, model-based methods of calculating the STV 
are more sensitive to the range of extreme values that may be obtained 
among the sample outcomes when the STV is being determined based on a 
relatively small number of samples. Therefore, we are specifying that 
the STV of your water samples calculated to determine whether your 
water meets the microbial quality criteria specified in Sec.  
112.44(b), must be derived as a model-based calculation based on the 
lognormal distribution. (See Comment 229 where we address guidance 
related to this issue.)
    Therefore, we are finalizing the microbial quality criteria for 
agricultural water used during growing activities for covered produce 
(other than sprouts) using a direct water application method of: (1) A 
geometric mean (GM) of your agricultural water samples of 126 or less 
colony forming units (CFU) of generic E. coli per 100 mL of water (GM 
is a measure of the central tendency of your water quality 
distribution); and (2) a statistical threshold value (STV) of your 
agricultural water samples of 410 or less CFU of generic E. coli per 
100 mL of water (STV is a measure of variability of your water quality 
distribution, derived as a model-based calculation approximating the 
90th percentile using the lognormal distribution).
    Using the RWQC as a starting point, we then considered available 
scientific information and recommendations to account for circumstances 
that are unique to produce growing (including irrigation), such as 
microbial die-off after application of water, which are factors that 
were not accounted for in formulating water quality requirements in the 
EPA RWQC (Ref. 123) (Ref. 143). We considered the World Health 
Organization's (WHO) Guidelines for the Safe Use of Wastewater, 
Excreta, and Greywater, Volume II, Wastewater Use in Agriculture, which 
were developed with the primary aim of ``maximizing public health 
protection and the beneficial use of important resources'' (Ref. 123). 
These guidelines are intended to be relevant ``to the intentional use 
of wastewater in agriculture and [are] also relevant where faecally 
[sic.] contaminated water is used for irrigation unintentionally'' and 
provide ``an integrated preventive management framework for safety.'' 
These guidelines recommend various health protection measures that can 
be used alone or in combination to achieve a specific microbial log 
reduction, or range of reductions, necessary to meet the desired health 
outcome. The health protection measures reflected in the WHO guidelines 
are intended to achieve a tolerable disease burden from consumption of 
raw food crops irrigated by treated wastewater of 10-6 
disability-adjusted life years per person, per year (Ref. 44). The 
post-irrigation microbial die-off and/or microbial removal provisions 
in final Sec.  112.45(b)(1) were informed by our analysis of these WHO 
guidelines.
    (Comment 210) In the supplemental notice, in relation to the 
microbial quality criteria in proposed Sec.  112.44(c), we asked for 
comment on whether we should establish a single sample maximum level of 
E. coli above which the water should not be permitted for use in direct 
application (until specific follow-up actions are taken to ensure it 
meets the recommended microbial quality requirements) and, if so, what 
would be an appropriate maximum level (78 FR 58444). Some comments 
oppose a maximum threshold level of E. coli, arguing that it could lead 
to discontinuation of water unnecessarily because of the variability in 
quality of irrigation water, and one of these comments argues that any 
such maximum levels should be included in guidance rather than in 
regulation.
    (Response) We are not establishing a single sample maximum 
threshold of generic E. coli in relation to the microbial quality 
criteria in Sec.  112.44(b). Our approach to developing the standard 
for safe use of agricultural water during growing covered produce 
(other than sprouts) relies on measures taken by covered farms to know 
and respond to the quality of their agricultural water over the long 
term. Rather than setting a single sample maximum generic E. coli 
standard, we are establishing a STV of 410 CFU or less generic E. coli 
per 100 mL of water. The STV is a value that is derived as a model-
based calculation based on the lognormal distribution and approximates 
the 90th percentile of the water quality distribution. The use of an 
STV rather than a single sample maximum is designed to account for the 
variability of water sources, in particular of surface water sources.
    (Comment 211) Several comments recommend FDA set an ``interim'' 
microbial water quality requirement in proposed Sec.  112.44(c), and 
then pursue additional research to inform the development of a final 
microbial quality standard that accounts for the diversity in farming 
practices and produce commodities. Such comments advise that such an 
``interim'' standard should include a mandatory sunset provision, which 
they expect would provide an opportunity for stakeholders to work 
together to conduct research and develop meaningful commodity- and 
situation-specific microbial quality standards for agricultural water.

[[Page 74443]]

    (Response) As previously noted, we do not agree that more research 
is needed for us to finalize the provisions of this rule relating to 
agricultural water. We also disagree that we should establish 
requirements with sunset provisions as suggested by these commenters. 
As discussed in the 2013 proposed rule, the supplemental notice, and in 
this document, there is sufficient scientific information from which we 
conclude that the requirements in this rule minimize the risk of 
serious adverse health consequences and death, and are reasonably 
necessary to prevent the introduction of known or reasonably 
foreseeable hazards into produce and to provide reasonable assurances 
that produce is not adulterated. However, we do support additional 
research as a means of facilitating implementation of the rule and 
continuing advancement of scientific knowledge in this area, and we are 
pursuing regulatory science and research activities in collaboration 
with various partners (see Comment 174).
    (Comment 212) Several comments recommend other approaches for us to 
consider in establishing microbial quality requirements for Sec.  
112.44(b) uses, including: (1) Using the WHO standard, asserting it may 
be easier to implement and more easily understood by foreign producers; 
(2) adopting a qualitative standard to require that water must be of 
adequate quality for its intended use; and (3) applying the microbial 
standard for drinking water to agricultural water for a certain 
specified period prior to harvest, and evaluating whether water meets 
this standard using a single water test taken at a certain time prior 
to harvest. In addition, several other commenters argue that any 
agricultural water requirement for this purpose should be no more 
restrictive than the WHO standard.
    (Response) See Comment 209. The WHO guidelines present several 
illustrations for how to reduce risks associated with consuming raw 
crops irrigated by wastewater. However, these are only examples of how 
to apply the guidelines to reach the health-based target. They do not 
represent specific water quality criteria for particular commodities. 
The guidelines recommend several health protection measures, each of 
which can be used alone or in combination to achieve a specific 
microbial log reduction or range of microbial reductions necessary to 
meet the desired (<=10\-6\ disability-adjusted life years) health 
outcome. This rule draws upon the WHO water guidelines, but not as a 
fixed microbial quality standard, per se. As discussed in the 
supplemental notice, the WHO values (i.e., 1,000 CFU per 100 mL and 
10,000 CFU per 100 mL for root crops and surface crops, respectively) 
are better explained as illustrations of how specific health protection 
measures could be used together after waste water treatment to achieve 
the additional log reductions recommended for waste water reuse, and 
were not intended as absolute end points or maximum permitted levels 
for generic E. coli in irrigation water. As explained in (Ref. 44) 
regarding the review of water quality standards in development of the 
microbial quality criteria in Sec.  112.44(b), the WHO guidelines do 
not include any specific criteria for maximum acceptable E. coli levels 
in wastewater for agricultural use in the growing of produce. We also 
conclude that a quantitative microbial quality requirement that is 
enforceable and requires action by industry to ensure the criteria are 
met would be both more practicable and more protective of public health 
than a qualitative water quality standard alone. The microbial quality 
criteria we have established serve as objective measures to be applied 
to indicate the quality of agricultural water when used for certain 
specified purposes. Note that we are also retaining the general ``safe 
and of adequate sanitary quality'' qualitative standard in Sec.  
112.41, which applies to all agricultural water regardless of the 
specific intended use.
    In response to the comment suggesting requiring agricultural water 
to meet the drinking water standard for a specified period of time pre-
harvest and only requiring a single test, we do not believe it is 
necessary to require water used in the field to meet the drinking water 
standard in light of the die-off of microorganisms that can be expected 
to occur after application of agricultural water. As described in 
Comment 214, we conclude it is appropriate to account for microbial 
die-off between last irrigation and harvest, as well as between harvest 
and end of storage, as provided in Sec.  112.45(b)(1).
    (Comment 213) Several comments support the use of the GM and STV as 
proposed in the supplemental notice and prefer that approach over the 
original approach in the 2013 proposed rule (using a GM and a single 
sample maximum). These comments state that the GM and STV approach is 
risk-based, appropriately protective, flexible, and does not unduly 
burden farmers. However, other comments state the calculations related 
to GM and, in particular, STV required under proposed Sec.  112.44(c) 
are complicated and are likely to be confusing and challenging for 
farmers to implement. Some comments request that FDA provide assistance 
to farms regarding the calculation of GM and STV, and the application 
of the microbial die-off and/or removal provisions. Comments also ask 
FDA to develop guidance and web-based tools to help with these 
calculations.
    (Response) We appreciate the comments that recognize the value of 
the GM and STV approach as opposed to our original proposed approach 
that included a single sample maximum. However, we also recognize the 
need for outreach regarding how to calculate the GM and STV, how to use 
microbial die-off and/or removal rates, and how to calculate related 
time intervals. We intend to provide guidance on these topics in the 
Produce Safety Regulation Implementation guidance, which we expect to 
issue in the near future. In addition, we are exploring the development 
of an on-line tool that you can use to derive the GM and STV values and 
appropriate time intervals (in days) between last irrigation and 
harvest using the 0.5 log per day die-off rate, based on input of 
sample data, such that a farmer would not need to perform the necessary 
calculations themselves.
2. Allowance for Microbial Die-Off and/or Removal (Sec.  112.45(b)(1)) 
and Other Corrective Measures (Sec.  112.45(b)(2) and (b)(3))
    (Comment 214) Several comments support proposed Sec.  112.44(c)(1) 
and (c)(2) that would allow farms to account for microbial die-off or 
removal between last irrigation and harvest and between harvest and end 
of storage, or during activities such as commercial washing. These 
comments state these mechanisms provide flexibility; serve as a 
reasonable approach to identifying practices that reduce risk; and 
minimize the need for chemical water treatment. In addition, several 
comments suggest that these provisions should be expanded and applied 
to operations where there is no reasonable likelihood of direct water 
contact with the harvestable portion within a specified number of days 
before harvest.
    (Response) We are retaining the microbial die-off and removal 
provisions in final Sec.  112.45(b)(1)(i) and (b)(1)(ii). For the 
purposes of this rule, we define agricultural water as water used in 
covered activities on covered produce where water is intended to, or is 
likely to, contact covered produce or food-contact surfaces, including 
water used in growing activities and in harvesting, packing, and 
holding activities. Moreover, we use ``covered produce'' to refer to 
the harvestable or harvested part of the crop. Therefore,

[[Page 74444]]

the provisions in subpart E, including Sec.  112.44(b) and 
corresponding Sec.  112.45(b), do not apply to water that is not 
intended to or likely to come into contact with covered produce, and we 
are not establishing microbial quality criteria (or related microbial 
die-off or removal provisions) for such water. See also Comment 179.
    We are also making other revisions within final Sec.  112.45(b) to 
consolidate and clarify applicable options for corrective measures when 
agricultural water used during growing activities for covered produce 
(other than sprouts) using a direct water application method does not 
meet the microbial quality criteria in Sec.  112.44(b). That is, 
available options include (1) applying a time interval (in days) 
between last irrigation and harvest (Sec.  112.45(b)(1)(i)) and/or 
between harvest and end of storage and/or applying a (calculated) log 
reduction during activities such as commercial washing (Sec.  
112.45(b)(1)(i)); (see also Comment 218 discussing certain revisions to 
these provisions); (2) re-inspect your entire affected agricultural 
water system to the extent it is under your control, and among other 
steps, make necessary changes and adequately ensure that your water 
meets the criteria in Sec.  112.44(b) (Sec.  112.45(b)(2)); or (3) 
treat the water in accordance with Sec.  112.43 (Sec.  112.45(b)(3)). 
Consistent with our intent for the microbial quality criteria in Sec.  
112.44(b) to serve as a long-term water management tool, we further 
clarify in Sec.  112.45(b) that these corrective actions must be taken 
as soon as practicable, and no later than the following year. We expect 
you to apply these corrective measures as soon as it is practicable, 
considering various factors specific to your practices and commodities, 
including, for example, the timing when water testing results are 
obtained in relation to the current harvest of your commodity or 
commodities; whether you have a single or multiple commodities with 
different harvest cycles; and whether your commodity is of a nature 
such that the time intervals and/or (calculated) log reductions in 
Sec.  112.45(b)(1)(i) and/or (b)(1)(ii) can be applied. However, we 
require you to implement such corrective measures no later than the 
following year. If none of the corrective measures in Sec.  
112.45(b)(1)-(3) are used, or if such measures are not effective in 
achieving the required criteria, you must discontinue that use of the 
water from that source.
    (Comment 215) Several comments express concern that the burden is 
placed on covered farms to conduct research and identify appropriate 
microbial die-off or removal rate(s) that can be applied between 
harvest and end of storage or during activities such as commercial 
washing.
    (Response) As noted in the supplemental notice, at this time, we 
are not establishing a specific microbial die-off rate(s) between 
harvest and end of storage or specific microbial removal rate(s) during 
postharvest activities such as commercial washing because we do not 
have sufficient information to support the derivation of appropriate, 
broadly applicable microbial die-off or reduction rate(s) for these 
purposes. Nevertheless, we provide this option in final Sec.  
112.45(b)(1)(ii), along with revisions requiring you to use an 
accompanying maximum time interval or log reduction. See Comment 218. 
We are retaining this option so covered farms may establish and apply 
an adequate time interval or calculated log reduction using microbial 
die-off or removal rate(s) relevant to the covered produce and 
dependent on practices and conditions on the farm, provided the farm 
has adequate scientific data or information to support the conclusions. 
We are working with our stakeholders to facilitate research into 
appropriate die-off and/or removal rates for these activities, and we 
intend to disseminate useful scientific information, when available, 
such that farmers would be able to consider our recommendations and 
apply the new scientific information to their operations, as 
appropriate.
    (Comment 216) Several comments ask about the science underlying the 
microbial die-off rate in proposed Sec.  112.44(c)(1) that is used to 
determine the time interval between last irrigation and harvest. 
Comments state that the established rate may not be uniformly 
applicable across diverse real-world conditions on farms producing 
different commodities across the country.
    (Response) The microbial die-off rate in Sec.  112.45(b)(1)(i) is 
based on our review of currently available science. As explained in the 
supplemental notice, we determined that a microbial reduction rate of 
0.5 log per day provides a reasonable estimate of die-off under a broad 
range of variables including microbial characteristics, environmental 
conditions, crop type, and watering frequency. (See (Ref. 45) (Ref. 
144) for information about the studies we reviewed, our criteria for 
study selection, and our conclusions.) We recognize that microbial die-
off rates are dependent on various environmental factors, including 
sunlight intensity, moisture level, temperature, pH, the presence of 
competitive microbes, and suitable plant substrate. Although our 
analysis led us to conclude that a rate of 0.5 log per day provides a 
reasonable estimate of microbial die-off under a broad range of 
variables, we understand that different microbial die-off rates may 
occur between last irrigation and harvest under different circumstances 
(Ref. 45) (Ref. 144). For example, higher microbial die-off rates may 
occur under conditions of high ultraviolet radiation, high temperature 
exposures or low humidity, coupled with little or no precipitation in 
comparison to the die-off rates observed under cloudy, cool, and wet 
conditions (Ref. 123). Therefore, in final Sec. Sec.  
112.45(b)(1)(i)(B), 112.49(b), and 112.12, we are providing for the use 
of appropriate alternative microbial die-off rate(s) (as well as an 
accompanying maximum time intervals), provided you have adequate 
scientific data or information to support a conclusion that the 
alternative die-off rate would provide the same level of public health 
protection as the 0.5 log per day die-off rate in Sec.  
112.45(b)(1)(i)(A), 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. We expect 
that covered farms that rely on an alternative die-off rate under these 
provisions to use a rate that is supported by an equally robust and 
rigorous scientific analysis applicable to the region and crop for 
which the alternative would be used. We would expect such an 
alternative rate to be quantitatively demonstrated to be equivalent to 
the FDA-established rate under the relevant conditions, thus 
``providing the same level of public health protection'' as the FDA-
established rate and ensuring that the alternative rate would not 
increase the likelihood that the farm's covered produce will be 
adulterated, as required under Sec.  112.12.
    (Comment 217) One comment notes the importance of end-of-season 
irrigation water to overall yields, and asks FDA to consider the 
detrimental effects of ceasing irrigation in establishing the water 
standards.
    (Response) We recognize the importance of irrigation during produce 
production, and have provided options in Sec.  112.45(b)(1) that 
account for microbial die-off and/or removal post irrigation, as 
additional means to achieve the microbial quality criteria for 
agricultural water that is used in a direct application method during 
growing of produce (other than sprouts). We also note that we have 
incorporated flexibility for covered farms to use an alternative 
microbial die-off rate in lieu of our established die-off rate, under 
certain specified conditions (see

[[Page 74445]]

Sec.  112.49(b)). We expect that, in most cases, these provisions will 
provide sufficient flexibility for covered farms to achieve our 
microbial quality criteria, as soon as practicable, and no later than 
the following year, without having to cease irrigation. See also 
Comment 214 regarding timing of corrective actions and other available 
options.
    (Comment 218) Several comments state the microbial die-off and/or 
removal provisions in proposed Sec.  112.44(c)(1) and (c)(2) should not 
be allowed to be used when agricultural water exceeds a certain level 
of generic E. coli. These comments recommend a maximum time interval 
between last irrigation and harvest of 4 days, applying a microbial 
die[hyphen]off rate of 0.5 log per day. One comment provides the 
example that if the water quality is uncontrollable or testing results 
are between 410 and 41,000 CFU E. coli/100 mL, a time interval between 
last irrigation and harvest at a rate of 0.5 log per day, to a maximum 
of 4 days should be permitted, but that such flexibility for microbial 
die-off is not appropriate when water testing results indicate a level 
of above 41,000 CFU E. coli/100 mL.
    (Response) As discussed in the QAR, the timing of water application 
can affect the potential for produce 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 at the time of harvest, but the same water could be used 
to establish a crop because microbes die-off over time on the surface 
of produce. Studies reporting decay constant(s) measured over time have 
concluded that microbial die-off rates are highest immediately 
following contamination and slow over time (Ref. 45) (Ref. 144). This 
phenomenon, known as ``tailing,'' suggests microbial die-off curves are 
biphasic, i.e., two decay constants may be needed to accurately 
describe microbial die-off over time. Moreover, it suggests the initial 
time period immediately following a contamination event via irrigation 
is the most important time period in reducing the numbers of microbes 
(including pathogens) present on the crop.
    We also reviewed available literature for a maximum time interval 
that is appropriate when applying a microbial die-off rate of 0.5 log 
per day. The studies we reviewed indicate that greater microbial die-
off or decay rates occur during the early timeframe post-contamination, 
and although the die-off rate in these studies was established from 
survival data or decay rates for bacterial studies ranging from 2-7 
days, the specific timeframe for the biphasic shift in die-off was not 
identified (Ref. 45) (Ref. 144). Within this range identified in the 
literature, a maximum time interval of 4 days is reasonable because it 
serves as a general mid-point in time representing neither end of the 
range where microbial die-off was observed in these studies. A maximum 
time interval of four consecutive days is also consistent with 
recommendations by commenters. Therefore, we are adding a new 
limitation in Sec.  112.45(b)(1)(i)(A) that a time interval of no more 
than four consecutive days may be applied between last irrigation and 
harvest to achieve the microbial quality criteria in Sec.  112.44(b). 
In addition, we expect any scientifically-supported die-off rate that a 
farm applies as an alternative under Sec.  112.45(b)(1)(i)(B) between 
last application and harvest; or to determine the appropriate time 
interval between harvest and end of storage, in accordance with Sec.  
112.45(b)(1)(ii), to be similarly characterized in a manner that 
addresses the likely biphasic nature of microbial die-off (i.e., the 
two different decay constants of a rapid short-term die-off and a 
gradual long-term die-off). We also expect that if you develop an 
alternative to the microbial quality criteria in Sec.  112.44(b) and if 
you intend to take advantage of the provision in Sec.  112.45(b)(1)(i) 
applying die-off between last application and harvest, then you must 
also appropriately characterize a microbial die-off rate between last 
irrigation and harvest that relates to your alternative microbial 
quality criteria, including consideration of the likely biphasic nature 
of microbial die-off.
    (Comment 219) One comment requests flexibility to apply the 0.5 log 
per day die-off rate in proposed Sec.  112.44(c)(1) on a per hour, 
rather than a per day, basis.
    (Response) We have determined the microbial die-off rate of 0.5 log 
per day between last irrigation and harvest in final Sec.  
112.45(b)(1)(i)(A) based on our review and analysis of currently 
available evidence. There is not enough evidence to support modifying 
the die-off rate that is reported in time periods of days in current 
literature to microbial die-off per hour. Moreover, decay constants 
have been found to vary within the 24 hour cycle, depending on climatic 
and other conditions (Ref. 145) (Ref. 146) (Ref. 147) (Ref. 148) (Ref. 
149). Therefore, we do not believe it is appropriate to extrapolate the 
per day die-off rate to a per hour die-off rate.
    (Comment 220) Some comments question the need to subject water that 
is used in the growing of dry bulb onions using a direct water 
application method to the testing requirements in proposed Sec.  
112.45, particularly in light of the microbial die-off and removal 
provisions in proposed Sec.  112.44(c)(1) and (c)(2). These comments 
find the testing requirements burdensome and unnecessary for water used 
in the growing of dry bulb onions because harvest typically occurs 
weeks or months after irrigation. One comment suggests a 6-day time 
interval between last irrigation and harvest would be sufficient to 
account for a ``worst case scenario of 20,000 CFU generic E. coli/100 
mL'' water quality, and that dry bulb onion farms should be allowed to 
``opt out'' of testing requirements for untreated surface water in 
proposed Sec.  112.45(b), if they allow 6 days to elapse between last 
irrigation and harvest.
    (Response) We recognize that covered farms growing dry bulb onions 
typically have an extended period between last irrigation and harvest 
and between harvest and end of storage, which should help them comply 
with the microbial water criteria in final Sec.  112.44(b) for 
agricultural water that is used during growing of dry bulb onions using 
a direct application method. However, unless untreated surface water 
that is used during growing in a direct application method is tested, 
there would be no way to determine whether there is a need to apply a 
time interval between last irrigation and harvest and, if so, the 
appropriate time interval. Therefore, when required under final Sec.  
112.46, agricultural water testing and calculation of the GM and STV 
must be done to inform and determine the appropriate way(s) in which 
the water may be used. To take advantage of the die-off and/or removal 
options in Sec.  112.45(b)(1), you must first characterize the water 
quality by testing in accordance with Sec.  112.46(b) and calculate a 
GM and STV. Moreover, under Sec.  112.45(b)(1)(i), the use of the 
microbial die-off rate of 0.5 log per day between last irrigation and 
harvest is limited to four consecutive days (see Comment 218). At a 
rate of 0.5 log per day and a maximum of four days, the die-off option 
provided in Sec.  112.45(b)(1)(i)(A) could not, on its own, effectively 
achieve the microbial quality criteria for water containing 20,000 CFU 
generic E. coli/100 mL if this value represents the GM, as presented in 
the comment. You may instead apply an alternative microbial die-off 
rate under Sec. Sec.  112.45(b)(1)(i)(B), 112.49(b), and 112.12. To do 
so, you must have adequate scientific data and

[[Page 74446]]

information to support your conclusions, as required in those 
provisions, and you must determine an accompanying appropriate maximum 
time interval associated with your alternative die-off rate, similar to 
the 4-day maximum under Sec.  112.45(b)(1)(i)(A). Also, under Sec.  
112.45(b)(1)(ii), you may apply a microbial die-off rate between 
harvest and end of storage, and/or a microbial removal rate for 
activities such as commercial washing, that is relevant to your covered 
produce and dependent on practices and conditions on your farm, 
provided you have adequate scientific data or information to support 
your conclusions (see also corresponding documentation requirement in 
Sec.  112.50(b)(5)). As for the die-off or removal rates in Sec.  
112.45(b)(1)(ii), you must also determine an accompanying maximum time 
interval or log reduction associated with these die-off rates, similar 
to the 4 day maximum under Sec.  112.45(b)(1)(i)(A). See Comment 216.
    While these flexible options make it less likely that a dry bulb 
onion farm will find that its untreated surface water cannot meet the 
Sec.  112.44(b) criteria, the fact that each of these die-off or 
removal rates may have a maximum appropriate application limit means 
that they cannot be presumed to reduce the GM and STV of the most 
contaminated water sources to a level compliant with Sec.  112.44(b). 
Testing must be conducted to determine the quality of the water and 
determine whether it is usable within the requirements of the rule.
    (Comment 221) In the supplemental notice, we asked for comment on 
whether we should require farms to establish and maintain any 
documentation in relation to the option to apply a time interval 
between last irrigation and harvest. One comment recommends requiring 
records to be maintained on the time interval applied, how the time 
interval was calculated, and/or the dates of last irrigation and 
harvest corresponding to that time interval. The commenter also notes, 
however, that such records should be required only in the case where 
the agricultural water tested in accordance with proposed Sec.  112.45 
does not meet the microbial quality criteria established in proposed 
Sec.  112.44(c).
    (Response) We agree that documentation of the time interval 
applied, calculation of the time interval based on water testing 
results, and the dates of last irrigation and harvest corresponding to 
that time interval, must be prepared and maintained, when the provision 
in Sec.  112.45(b)(1)(i) is applied to achieve the microbial quality 
criteria in Sec.  112.44(b). Likewise, records must be made and kept of 
the time interval or calculated log reduction applied, calculation of 
the time interval or log reduction based on water testing results, and 
the dates of harvest and end of storage or other relevant activities 
corresponding to that time interval or log reduction, when the 
provision in Sec.  112.45(b)(1)(ii) is applied to achieve the microbial 
quality criteria in Sec.  112.44(b). Such records would be required 
only when such a time interval or log reduction is applied, in 
accordance with Sec.  112.45(b)(1), and not when no such time 
interval(s) is applied. We are adding this records requirement in new 
Sec.  112.50(b)(6) (corresponding with our elimination of proposed 
Sec.  112.161(b)), which requires you to document any actions you take 
in accordance with Sec.  112.45. This new section also provides 
specifically that you must prepare and maintain documentation of any 
time interval or (calculated) log reduction applied in accordance with 
Sec.  112.45(b)(1)(i) and/or (b)(1)(ii), including the specific time 
interval or log reduction applied, how the time interval or log 
reduction was determined, and the dates of corresponding activities 
(such as the dates of last irrigation and harvest, the dates of harvest 
and end of storage, and/or the dates of activities such as commercial 
washing).

G. Testing of Agricultural Water (Sec.  112.46)

1. Testing of Agricultural Water Not Required Under Certain Conditions 
(Sec.  112.46(a))
    (Comment 222) Some comments believe proposed Sec.  112.45(a) would 
allow farms to draw and hold municipal water with no further 
requirement to test that water. These comments state that the 
provision, as proposed, is not sufficiently protective of the quality 
of water from public water system to forgo testing.
    (Response) In final Sec.  112.46(a), we are retaining proposed 
Sec.  112.45(a), which establishes that there is no requirement to test 
any agricultural water that is subject to the requirements of Sec.  
112.44 when: (1) You receive water from a public water system, under 
the conditions specified in that provision (Sec.  112.46(a)(1)); (2) 
you receive water from a public water supply that furnishes water that 
meets the microbial quality requirement in Sec.  112.44(a), under the 
conditions specified in that provision (Sec.  112.46(a)(2)); or you 
treat water in accordance with Sec.  112.43 (Sec.  112.46(a)(3)).
    This exception from the testing requirements that follow in Sec.  
112.46(b) and (c) applies only when water received from a public water 
system (as in Sec.  112.46(a)(1)) or a public water supply (as in Sec.  
112.46(a)(2)) is not held under your control in a way that meets the 
definitions of ``ground water'' or ``surface water'' before you use it 
as agricultural water. See the definitions of ``ground water'' and 
``surface water'' in Sec.  112.3(c). If you hold water received from a 
public water system or public water supply in either a ground water or 
a surface water capacity, the water is exposed to potential 
contamination in a manner similar to other ground water or surface 
water sources, such that it becomes a ``ground water'' or ``surface 
water'' source as applicable, and the testing requirements applicable 
to untreated ground water or untreated surface water will apply, as 
established in Sec.  112.46(b) and (c).
    We are also revising Sec.  112.46(a)(1) to add a reference to the 
relevant EPA definition of a State approved to administer the SDWA 
public water supply program by adding a cross reference to the relevant 
definition in 40 CFR 141.2. The definition of ``State'' for this 
purpose includes, in relevant part, the agency of the State or tribal 
government which has jurisdiction over public water systems.
    (Comment 223) One comment asks why a body of water, such as a 
river, would need to be tested if it meets the federal water quality 
standards.
    (Response) The Water Quality Standards (WQS), issued under the CWA, 
define the goals for a waterbody by designating its uses, setting 
criteria to protect those uses, and establishing provisions such as 
anti-degradation policies to protect waterbodies from pollutants. The 
WQS regulation at 40 CFR part 131 describes the requirements and 
procedures for States and authorized tribes to develop, adopt, review, 
revise, and submit water quality standards. It also establishes the 
requirements and procedures for EPA to review, approve, disapprove, and 
promulgate water quality standards as authorized by section 303(c) of 
the CWA (33 U.S.C. 1313(c)). Water that is determined to be within the 
established WQS for the waterbody does not necessarily meet the 
agricultural water requirements in this rule, which as discussed 
throughout this section, are intended to prevent the introduction of 
known and reasonably foreseeable hazards into produce and to provide 
reasonable assurances that produce is not adulterated. For example, 
many farms rely on ditches to direct water to the field, and these 
ditches are normally open to the environment and can cover significant 
distances. There are no

[[Page 74447]]

controls in the CWA that would account for potential contamination in 
these ditches.
2. Approach to Testing Untreated Surface Water (Sec.  112.46(b)) and 
Untreated Ground Water (Sec.  112.46(b) and (c))
    (Comment 224) Several comments support the revisions we proposed in 
the supplemental notice to proposed Sec.  112.45 that we had proposed 
in the 2013 proposed rule. These comments state the tiered approach to 
testing described in the supplemental notice better reflects current 
sources of agricultural water and farmers' practices related to use of 
those sources of water. These comments also find the proposed tiered 
approach less burdensome than the originally proposed requirements. 
Conversely, several other comments state the revisions to proposed 
Sec.  112.45 proposed in the supplemental notice result in a testing 
scheme that is overly complicated, burdensome, lacks scientific 
justification, and does not incorporate sufficient flexibility. These 
comments state the proposed requirements would impose significant costs 
on farmers, particularly when agricultural water is derived from 
multiple water sources and/or when the quality of water from a source 
is highly variable.
    (Response) In the 2013 proposed rule, we proposed requirements for 
specific frequencies of testing untreated surface water used for the 
purposes in proposed Sec.  112.44, ranging from once every 7 days to 
once per month during the growing season, depending on certain 
specified circumstances related to the source of untreated surface 
water. A majority of stakeholder concerns with those proposed testing 
frequencies centered on the financial burden imposed on farms, in 
particular, under a weekly testing requirement; arguments that FDA did 
not provide scientific data in support of the proposed testing 
frequencies; and the need for a more flexible approach accounting for 
the variability in water quality associated with various water sources 
and the particular use of the water during growing, harvesting, or 
postharvest activities. Taking into account these comments, in the 
supplemental notice, we made the proposed requirements more flexible by 
proposing tiered approaches to testing untreated surface water 
(proposed Sec.  112.45(b)) and untreated ground water (proposed Sec.  
112.45(c)).
    We continue to believe our proposed tiered approaches for testing 
untreated surface water and untreated ground water used for certain 
purposes will allow farms to make decisions about safe use of available 
water sources prior to the beginning of the next growing season; adjust 
testing frequencies dependent on long-term test results and 
historically derived data; and reduce the required frequency of testing 
from the testing requirements of the originally proposed rule. A key 
objective of our requirements for water testing in relation to the 
microbial quality criteria in Sec.  112.44(b), specifically, is to 
establish a testing approach sufficient to adequately characterize the 
quality of the agricultural water such that the information can be used 
by farms to make informed and appropriate decisions about its use and/
or the need for any appropriate corrective actions, prior to such use 
in the future.
    We explained our scientific basis, and underlying statistical 
analysis, for these testing frequencies in a reference memo that 
accompanied the supplemental notice, which we have updated for the 
purposes of this rule (Ref. 99). Our evaluation indicates that minimum 
sample sizes of 20 samples for initial survey and of 5 samples for 
annual survey, which we are establishing in our testing scheme for 
untreated surface water in Sec.  112.46(b), are necessary to provide 
sufficient precision of estimation of the microbial quality profile 
(which includes GM and STV values for generic E. coli) in order to then 
use that information to determine and verify appropriate conditions of 
use of that water (Ref. 99). Similarly, for untreated ground water, we 
conclude that a minimum sample size of 4 samples for initial survey and 
of 1 sample for annual survey is necessary when the previous samples 
have met the microbial quality criteria under the testing scheme that 
we are establishing in Sec.  112.46(b).
    We have introduced flexibility into the testing requirements to 
minimize burden to the extent possible. For example, we provide 
flexibility with respect to the timing of sample collection, 
recognizing the timing of the use of agricultural water in a direct 
application method during growing varies by crop, region, season, and/
or from year to year. This flexibility is intended to permit farms to 
tailor their sampling of water to the unique circumstances relevant to 
their crop(s) and practices and conditions on their farm. In addition, 
in new Sec.  112.49(c) and (d), we are allowing, under certain 
specified conditions, the use of an alternative water testing frequency 
in lieu of the required minimum number of samples for initial and 
annual surveys under Sec.  112.46(b)(1)(i)(A) and (b)(2)(i)(A), 
respectively, for testing untreated surface water that is used during 
growing activities using a direct application method for produce (other 
than sprouts). We are also adding a corresponding provision, in new 
Sec.  112.50(b)(8) to require documentation of the scientific data or 
information you rely on to support any such alternative to the required 
water testing frequencies. In addition, we have also included 
provisions to permit data sharing among farms as well as to permit 
covered farms to use data collected by third parties, under certain 
specified circumstances (see Sec.  112.47(a)). We realize that the 
testing requirements may be particularly challenging for farms that 
have multiple agricultural water sources and we encourage farms to 
provide us with details of their specific situations so that we can 
consider flexible approaches to testing multiple sources.
    Moreover, in final Sec.  112.46(b), we apply the same approach to 
testing untreated ground water as the approach for testing untreated 
surface water used during growing for covered produce (other than 
sprouts) using a direct water application method, except that fewer 
tests are required at each stage for ground water as compared to 
surface water (see Comment 225 and Comment 232). We have combined the 
testing frequency provisions for untreated surface and ground water 
used for Sec.  112.44(b) purposes into one provision for editorial 
reasons and to more clearly demonstrate the differences and 
similarities between the testing required for the two types of sources 
when the water is used for the same purpose. We note that this retains 
the same ground water testing frequency for these purposes as proposed 
in the supplemental notice as Sec.  112.45(c).
    In addition, we are revising proposed Sec.  112.45(c) to separately 
address the testing of untreated ground water when used for purposes of 
Sec.  112.44(a) (see final Sec.  112.46(c)).
    Similarly, in final Sec.  112.46(c), we have retained the general 
approach as well as the specific frequency for testing of untreated 
ground water when used for purposes of Sec.  112.44(a), as proposed in 
the supplemental notice in proposed Sec.  112.45(c).
    (Comment 225) One comment states that it is critical to monitor the 
quality of water used during growing of produce, and supports testing 
untreated surface water and untreated ground water used during growing 
at a greater frequency than the frequency we proposed, to allow earlier 
detection of any contamination of the water.
    (Response) The requirements for testing untreated surface water and

[[Page 74448]]

untreated ground water used for Sec.  112.44(b) purposes represent 
science-based minimum standards for the safe production and harvesting 
of covered produce that we have determined minimize the risk of serious 
adverse health consequences or death. These testing protocols will 
enable farms to make decisions about safe use of available water 
sources prior to the beginning of the next growing season, and to 
adjust testing frequencies based on long-term test results and 
historically-derived data. We specify the required testing frequencies 
that we conclude, based on our statistical analysis, are necessary for 
sufficient precision of estimation of the microbial quality profile, 
considering the average variability in the quality of untreated surface 
water and ground water sources. However, these provisions do not 
preclude a covered farm from testing at a greater frequency than that 
required under Sec.  112.46(b)(1)(i) or 112.46(b)(2)(i), as appropriate 
based on your observations, experience, and practices related to your 
agricultural water source(s), farming operation, and commodities.
    (Comment 226) One comment suggests that FDA should allow each State 
to develop its own testing regime for ensuring water meets the 
microbial quality standard in proposed Sec.  112.44(c), subject to FDA 
approval. This commenter believes such an approach would allow States 
to tailor testing requirements to the unique circumstances farms 
encounter in a particular region and suited to growing conditions and 
variability of water sources in that region.
    (Response) Under the provisions in subpart P of part 112, a State 
(or tribe or foreign country) may request a variance from one or more 
of the requirements in part 112. A competent authority in a State that 
considers a water testing approach that deviates from the requirements 
in Sec.  112.46 to be more appropriate for covered farms within that 
State may submit a request for a variance, in accordance with the 
provisions in subpart P. The request for a variance in relation to the 
testing requirements may include requests for a different testing 
scheme for untreated surface water and/or ground water sources (in lieu 
of the tiered approaches we have established in Sec.  112.46(b)), 
whereas the provisions for alternatives under Sec.  112.49(c) and (d) 
are restricted only to the use of alternative testing frequencies in 
lieu of the frequencies we identified in Sec.  112.46(b)(1)(i)(A) and 
(b)(2)(i)(A) for untreated surface water, and do not extend to the 
entire tiered scheme set forth in Sec.  112.46(b) more broadly.
    (Comment 227) Some comments assert that the proposed testing 
frequency requirements in proposed Sec.  112.45 significantly favor use 
of ground water over surface water, which the commenter believes may be 
contrary to regional efforts to prevent overdraft of aquifers.
    (Response) The differences between the testing frequency 
requirements for untreated surface water and untreated ground water 
sources in Sec.  112.46(b) are based on the difference in the expected 
variability in quality between these two types of sources (see Comment 
225 and Comment 232). We have evaluated the potential effects of the 
produce safety regulation on the human environment in the United 
States. Our evaluation and conclusions based on that evaluation are 
described in the final EIS (Ref. 126). We refer you to that document 
for a detailed discussion of the potential environmental effects of the 
produce safety regulation, including those associated with the 
standards for agricultural water in subpart E of part 112. This 
analysis includes potential impacts related to pesticide use, chemical 
treatment of agricultural water, changes in ground water demand, and 
existing water quality standards. FDA has considered these potential 
impacts when making its decision on the provisions to be finalized 
(Ref. 150).
    (Comment 228) Some comments express concern that the testing 
approach places burden on covered farms to test water sources, 
including water they receive from irrigation districts, over which they 
have no control. One commenter believes the responsibility should be on 
the government or on the irrigation districts, not the farm. Similarly, 
another comment points out it may not be possible for farms to correct 
a contamination problem when the source of contamination is not in 
their control. Another commenter states that if a farm is receiving 
water from an irrigation district, the farm may not know the water 
quality and cannot establish the appropriate time interval to account 
for microbial die-off.
    (Response) Regardless of the source of water or who supplies it to 
the farm, a covered farm is responsible for ensuring the safe and 
appropriate use of that water in covered activities. Therefore, whether 
or not the irrigation districts provide information about the quality 
of water they supply to a farm, the covered farm must take measures to 
understand the quality of water under their control that is used as 
agricultural water during the growing, harvesting, packing, or holding 
of covered produce, including complying with the testing requirements 
in Sec.  112.46 when applicable. Test results obtained through such 
testing will give farms information about the quality of their water 
and how it may be used in compliance with the rule.
    We understand that many covered farms are dependent on irrigation 
districts to supply water for use in farming, and some covered farms 
have no control over the quality of the water at the time and place at 
which they receive the water. We encourage irrigation districts to 
conduct sampling and testing around the watershed that they manage and 
to share the data on its water quality with farms that receive the 
water from that watershed. As described in the supplemental notice, for 
example, covered farms sourcing water from an irrigation district may 
consider using water testing data from the district sampling program. A 
covered farm considering the district sampling program data would need 
to determine whether the water source(s) sampled adequately represent 
the covered farm's agricultural water. The covered farm would also need 
to consider whether the district's data set includes samples collected 
during a time period(s) as close as practical to the covered farm's 
harvest time; whether the district's data set satisfies the minimum 
number of samples the farm is required to have under the rule; and 
whether the district's data were obtained using appropriate test 
methods, as described in subpart N of part 112 and cross-referenced in 
new Sec.  112.47(b). In addition, the covered farm would need to get 
and keep records of the district's testing that satisfy the rule's 
recordkeeping requirements.
    (Comment 229) Several comments ask for guidance, technical 
assistance, and outreach related to water testing requirements, 
including sampling methods and procedures, so farms know how to 
properly collect samples, process them for testing, and transport them 
in a sanitary manner. Some comments state that the GM and STV 
calculations and subsequent analysis necessary to test, verify, and 
ensure compliant use of agricultural water, are complicated, and that 
most farmers do not have the expertise necessary to implement these 
provisions.
    (Response) In section XXII of this document, we discuss our plans 
to work with various organizations on outreach and education for 
effective implementation of the produce safety regulation. We agree 
training and outreach will be necessary to ensure covered farms 
understand the water testing requirements. Relevant staff will

[[Page 74449]]

need to be appropriately trained to properly sample, test, and make the 
necessary calculations to determine how best to use their water. We 
will consider addressing relevant issues, including appropriate water 
sampling methods and procedures, in the Produce Safety Regulation 
implementation guidance to be issued in the near term. In addition, we 
are exploring the development of an online tool to allow covered farms 
to derive their GM and STV values and appropriate time intervals 
between last irrigation and harvest using the 0.5 log per day die-off 
rate, based on input of sample data, such that farms would not need to 
perform the necessary calculations themselves.
    (Comment 230) Several comments ask for clarification on whether and 
how testing requirements apply in relation to water used during 
different stages of growing or production, particularly in reference to 
contact with the ``harvested or harvestable portion'' of the crop. For 
example, one comment asks whether and how proposed Sec.  112.45(b) 
applies to water used in frost protection sprays, prior to any 
flowering or fruit production, in tree crops.
    (Response) The testing requirements in Sec.  112.46(b) require 
samples to be collected as close in time as practicable to, but prior 
to, harvest. These requirements are intended to provide a true 
reflection of the agricultural water that is representative of your use 
of the water and near the time of harvest, so the data can then be used 
to determine the appropriate use of that water. In Sec.  112.3(c), we 
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). 
Moreover, we define the term ``covered produce'' in relevant part to 
refer to the harvestable or harvested part of the crop. Under these 
definitions, water used on a tree crop prior to any flowering or fruit 
production does not constitute ``agricultural water'' because it is not 
intended to, or likely to, contact covered produce (meaning the 
harvestable or harvested part of the crop) or food-contact surfaces.
    (Comment 231) One comment expresses concern about the extent to 
which imported produce would be subject to the agricultural water 
quality requirements, and recommends that foreign producers be required 
to have evidence of water testing and monitoring to ensure that they 
are meeting the same requirements as domestic farms.
    (Response) Under the final FSVP rule (published elsewhere in this 
issue of the Federal Register), FDA is establishing requirements for 
importers to verify that imported food, including produce, is produced 
in compliance with applicable FDA food safety regulations, including 
this rule, or is produced in accordance with processes and procedures 
that ensure the same level of public health protection as is required 
under these regulations in the United States. For imported produce, 
this will mean that importers must verify that imported produce was 
grown, harvested, packed, and held in accordance with the same 
agricultural water requirements, or equally protective measures, as 
domestic produce. Importers must have documentation of this 
verification which, in the case of produce that will not be 
manufactured/processed, is likely to be accomplished through an on-site 
audit.
    (Comment 232) Several comments support the use of greater minimum 
testing frequencies for untreated surface water sources as compared to 
untreated ground water sources used for the same purposes. Conversely, 
several other comments state that there should be no difference between 
minimum testing frequencies for surface water and ground water sources. 
This latter set of commenters believe the testing parameters should 
instead be consistent across the different water sources but should 
still be science-based and reflect risks assessed for each operation.
    (Response) We disagree with comments arguing that water from 
surface water and ground water sources should be tested at the same 
frequency. The approach we are adopting for water testing in Sec.  
112.46 is responsive to comments that requested that we establish a 
risk-based, flexible testing approach that accounts for variability in 
microbial water quality from different sources, considers the specific 
use of water from a particular water source, and contemplates the 
reduced likelihood of contamination from well-designed and adequately 
maintained water systems. As described in the 2013 proposed rule, 
surface watersheds are subject to a great number of external forces 
that shape their overall composition, chemistry, and microbial water 
quality (e.g., erosion, run-off, dust, suspended sediments). In 
contrast, ground water sources typically contain microorganisms, 
including pathogens, much less frequently, due to the natural filtering 
mechanism of soil (Ref. 118). We recognize, however, that ground water, 
which is often believed to be more protected from contamination, can be 
contaminated. Ground water can be compromised and its microbial water 
quality degraded if wells are improperly constructed, poorly 
maintained, improperly located (e.g., near areas of extensive livestock 
production or fields where manure is applied) or if the wells are 
drawing water from a contaminated aquifer (Ref. 119) (Ref. 151) (Ref. 
152) (Ref. 153) (Ref. 154). On the other hand, 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 run-off may 
result in a spike in microbial population of the water due to external 
inputs. We conclude that, although there exists significant potential 
for contamination of both ground and surface waters, surface water 
sources are inherently subject to a greater potential for contamination 
than properly designed, constructed, and well-maintained ground water 
sources. Therefore, although we require you to test both ground water 
and surface water sources used for certain purposes, where both types 
of sources may be used for the same purpose under Sec.  112.44(b), we 
require a lesser frequency of testing for ground water than for surface 
water sources (see Sec.  112.46(b)). We acknowledge that ground water 
sources can become contaminated, for example, if they are improperly 
maintained. The testing frequencies established in Sec.  112.46 for 
such sources, and the requirements in Sec.  112.42 to regularly inspect 
and maintain such sources, are designed to address this possibility.
    It is important to note that some water that comes from underground 
is subject to direct influence by surface water, and therefore is not 
considered ``ground water'' for purposes of this rule. In the 2013 
proposed rule, we proposed a definition of ``surface water'' as, ``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'' to distinguish 
such water sources from other water sources that are less likely to 
become contaminated, i.e., ``ground water'' sources (see 78 FR 3504 at 
3548). We are now establishing a definition of

[[Page 74450]]

``ground water'' in Sec.  112.3(c), and revising the definition of 
``surface water'' in that section, to clarify the differences between 
the two sources for the purposes of this rule. The definition of 
``ground water'' is ``the supply of fresh water found beneath the 
Earth's surface, usually in aquifers, which supply wells and springs. 
Ground water does not include any water that meets the definition of 
surface water.'' We are amending the definition of ``surface water'' to 
read, ``All water open to the atmosphere (rivers, lakes, reservoirs, 
streams, impoundments, seas, estuaries, etc.) and all springs, wells, 
or other collectors that are directly influenced by surface water.'' 
Through inclusion of the phrase, ``all springs, wells, or other 
collectors that are directly influenced by surface water,'' the 
definition of ``surface water'' includes, for example, water drawn from 
an underground aquifer that has been recharged with surface water 
(i.e., an aquifer into which humans have injected surface water to 
replenish the aquifer). The definition of ``ground water'' also 
specifies that ``[g]round water does not include any water that meets 
the definition of surface water.'' Thus, where a ground water source is 
directly influenced by surface water, it no longer meets the definition 
of ``ground water'' and must be considered to be surface water for the 
purposes of this rule. ``Directly influenced by surface water'' 
includes direct influences that are significant, such as a consistent 
inflow of surface water. The term ``collectors'' in the definition of 
``surface water'' means sources of accumulated water or vessels that 
collect and hold accumulated water such that it may be subject to 
external influence. See also discussion under Comment 184.
    The specific frequencies for testing that we have established in 
Sec.  112.46 are intervals that are reflective of the varying potential 
for changes in water quality between ground water sources and surface 
water sources. Our analysis suggests that a minimum number of samples 
required in ``average'' surface water sources would be 20 samples, 
assuming a standard deviation of 0.4 (of log abundance of E. coli). If 
you have a discrete surface water source that is minimally impacted by 
external forces, such as run-off, such that there is less variation in 
its microbial quality than an average surface water source, you may be 
able to test the water at frequency lower than that required in Sec.  
112.46(b)(1)(i)(A) or Sec.  112.46(b)(2)(i)(A). To account for such 
circumstances, we are providing in Sec.  112.49(c) and (d) for the use 
of an alternative testing frequency (in lieu of those required in Sec.  
112.46(b)(1)(i)(A) or Sec.  112.45(b)(2)(i)(A)), under the conditions 
specified in Sec.  112.12. On the other hand, because ground water 
sources (as we have defined ``ground water'' in Sec.  112.3(c)) are 
generally less variable, the required testing frequency for ground 
water in the rule is lower than for surface water when both types of 
sources may be used for the same purpose (see Sec.  112.46(b)), and no 
alternative option for different testing frequencies is available for 
ground water sources.
    (Comment 233) Several comments state the importance of making sure 
that water tests are conducted properly by certified and accredited 
labs. Some comments ask FDA to establish standards and procedures for 
third-party laboratories that perform the tests.
    (Response) We are currently working on a proposed rule to implement 
section 202 of FSMA (section 422 of the FD&C Act), which addresses 
``Laboratory Accreditation for Analyses of Foods.'' Neither model 
laboratory standards nor laboratory accreditation are within the scope 
of the produce safety regulation in part 112.
    Water testing required under this rule must be conducted using 
certain methods in accordance with Sec.  112.151, as required under 
Sec.  112.47(b). In addition, we are specifying in 112.47(b) that 
agricultural water samples must be aseptically collected. Aseptic 
sampling, often used for product and environmental samples, is a 
sampling technique used to assure that the microbial load of a sample 
is not affected by the sampling method and/or the sample collector does 
not contaminate the source from which the sample is collected. The use 
of sterile sampling implements and containers and a prescribed sampling 
method defines aseptic sampling (Ref. 155) (Ref. 156) (Ref. 157). 
Collecting and delivering samples to the laboratory using an aseptic 
technique also helps assure the microbiological findings accurately 
reflect the agricultural water at the time of sampling.
3. Timing of Collection of Water Samples for Testing Required Under 
Sec.  112.46(b) and (c)
    (Comment 234) Some comments request clarification on the meaning of 
the phrases, ``as close to harvest as practical,'' ``during growing 
activities,'' and ``as it is used'', which we used in proposed Sec.  
112.45(b) and/or Sec.  112.45(c). Some comments point out the time 
period for harvesting varies across regions and ranges from a few days 
to several months or year round. Other comments support the provision 
as proposed, and state that it allows the time frame to be determined 
by the farmer based on the wide variation in growing seasons, overlap 
of growing seasons for multiple crops, and likelihood of pathogen die-
off prior to harvest.
    (Response) For testing of untreated surface water or untreated 
ground water used during growing activities using a direct water 
application method, the initial and annual survey samples must be 
representative of your use of the water and must be collected as close 
in time as practicable to, but prior to, harvest (see Sec.  
112.46(b)(1)(ii) and Sec.  112.46(b)(2)(ii)). We recognize the timing 
of the use of agricultural water using a direct application method 
varies by crop, region, season, and/or from year to year. By revising 
the rule to use the term ``representative of your use of the water'' in 
lieu of ``as it is used,'' we intend to clarify that agricultural water 
should be collected for analysis around the time of harvest so that 
samples will be representative of the water that is applied during the 
end of the growing season. Samples collected from the source water when 
it is not being applied to the crop would not fulfill this requirement. 
We intend the wording ``collected as close in time as practicable to, 
but prior to, harvest'' to permit farms to tailor their sampling of 
water to the unique circumstances relevant to their crop(s) and 
practices and conditions on their farm. The agricultural water applied 
prior to harvest must be targeted for sampling, recognizing that in 
some circumstances such applications may not be preplanned (e.g., 
application of crop protection water due to early frost or unusually 
hot, dry weather). Further, sample collection should be designed to 
represent events that can reasonably be expected to both impact water 
quality (e.g., rainfall wildlife and domesticated animal movement 
through upstream water systems) and occur during the end of the growing 
season. We expect covered farms to determine the appropriate time for 
sampling to meet the requirements that samples be collected during a 
time period(s) as close as practicable to harvest, while recognizing 
that samples of agricultural water taken more than a few weeks prior to 
harvest are less representative of the agricultural water applied at 
the end of growing when the risk of produce contamination is greater. 
We anticipate seasonal trends in microbial water quality that can be 
captured in the long-term microbial water quality profile. In addition, 
we do not consider multiple samples collected in a single day to

[[Page 74451]]

provide adequate variation as the distribution estimates resulting from 
such a sampling plan would defeat the purpose of the microbial water 
quality profile. We also do not consider samples collected after the 
final harvest of the crop (for a single crop farm) to be representative 
of the agricultural water applied to that crop.
    In addition, we intend the wording ``representative of your use of 
the water'' and the requirement that samples must be ``collected as 
close in time as practicable to, but prior to, harvest'' to ensure 
that, when testing water used for growing activities of produce (other 
than sprouts) using a direct application method, the samples for 
initial and annual surveys are collected prior to harvest and at a time 
that can be reasonably expected to represent the quality of the water 
when it is being applied to the crop. Collection before harvest is 
necessary in order for the samples and the microbial water quality 
profile to represent the water used for the purposes in Sec.  
112.44(b). Collection close to harvest is necessary because there are 
certain seasonal variations in water quality that may be relevant to 
the microbial water quality profile, such as harvesting during a time 
of heavy, seasonal rains or harvesting of commodities at the end of the 
summer when water temperatures may be elevated compared to the 
beginning of the summer. The microbial water quality profile is 
intended to capture long-term trends related to quality of water as it 
is used close to harvest, and sample collection must be done with the 
understanding that recurring patterns of water quality variations are 
often seen on an annual basis. See also a discussion of the definition 
of ``direct water application method'' in section IX.B of this 
document.
    On the other hand, for untreated ground water used for purposes of 
Sec.  112.44(a), considering the nature of different uses spanning 
across different covered activities specified in that provision, we 
require that samples be taken at least four times either during the 
growing season or over a period of one year, as applicable, using a 
minimum total of four samples collected to be representative of the 
intended use(s) (see Sec.  112.46(c)). See Comment 229.
4. Clarification of Terms Used in Sec.  112.46
    (Comment 235) Some comments oppose the use of the term ``water 
quality profile,'' stating the concept is not clearly explained and/or 
not necessary.
    (Response) As used in this rule, ``microbial water quality 
profile'' generally refers to the set of data that provides information 
about the microbial quality of water from a specific water source, 
based on which a covered farm can determine whether the water meets the 
microbial quality criteria in Sec.  112.44(b) and make a decision 
regarding corrective measures, as necessary, under Sec.  112.45(b). The 
microbial water quality profile consists of two numerical values of 
generic E. coli in the water: The GM and the STV. The GM and STV values 
are initially calculated using data obtained in an initial survey and 
updated annually thereafter. The GM and STV values are initially 
derived based on the initial survey data set (described in Sec.  
112.46(b)(1)), which consists of a minimum total of 20 samples for 
untreated surface water sources (taken over at least 2 and no more than 
4 years) and 4 samples for untreated ground water sources (taken during 
the growing season or over a period of one year). The GM and STV values 
are then revised annually based on annual survey data (described in 
Sec.  112.46(b)(2)). For untreated surface water sources this entails 
taking at least 5 new samples, and for untreated ground water this 
entails taking at least one new sample. The new samples are then 
combined with your most recent data from within the previous 4 years, 
to make up a rolling dataset of 20 samples for untreated surface water 
and 4 samples for untreated ground water, and the GM and STV values are 
recalculated using this updated data set to update the microbial water 
quality profile.
    (Comment 236) Some comments request clarification on the meaning of 
``statistical threshold value.''
    (Response) The ``statistical threshold value'' is a value that 
approximates a specified percentile of a distribution, which depends 
upon the inherent variability of the observations in a sample set as 
well as their central tendency. For purposes of the testing 
requirements in Sec.  112.46(b) and (d), STV is a value that is derived 
as a model-based calculation based on the lognormal distribution and 
approximates the 90th percentile of the water quality distribution. For 
clarity, we are specifying in Sec.  112.44(b) that ``STV is a measure 
of variability of your water quality distribution, derived as a model-
based calculation approximating the 90th percentile using the lognormal 
distribution.'' See also our discussion in the supplemental notice at 
79 FR 58434 at 58444 for additional information. We note that we are 
exploring the development of an on-line tool that you can use to derive 
STVs and certain other values (such as GM values and appropriate time 
intervals (in days) between last irrigation and harvest using the 0.5 
log per day die-off rate) based on input of sample data, such that a 
farmer would not need to perform the necessary calculations themselves.
    (Comment 237) Several comments request clarification on the meaning 
of the term ``water source,'' as it relates to the water testing 
requirements in proposed Sec.  112.45(b), (c), and (d). One comment 
recommends that FDA broadly define ``water source'' as ``any reasonable 
portion of a watershed where a sanitation survey identifies no 
reasonably foreseeable point or nonpoint source of microbial discharge 
between agricultural water and withdrawal points.'' Another comment 
provides an example of an open irrigation ditch and questions whether 
water samples would be required for each irrigation district, at each 
pump site or water box, for each block or branch of the irrigation 
system, or for each sprinkler head. This commenter also asks whether a 
farm using multiple sources of water for irrigation would need to 
conduct a baseline survey of 20 samples over two years for each source. 
Comments ask whether a single source can be used for multiple 
commodities or to irrigate noncontiguous fields. Another comment notes 
testing agricultural water stored in holding containers (such as 
barrels) would be impractical and expensive.
    (Response) We consider each agricultural water source in your 
operation to be a discrete body of water that is representative of the 
microbial quality of agricultural water from that source used in your 
growing, harvesting, packing, or holding activities. For example, if 
you have a surface water impoundment on your farm that stores water to 
be used as agricultural water, but you also source water from a river 
that you use for the same purpose, you would need to consider these two 
be two different water sources, as each delivers water that is 
distinctly different in origin and likely to differ in overall 
composition and characteristics. Or if, for example, you source some 
water directly from a properly constructed well on your property, and 
you also draw water from the same source and hold it in a holding pond 
on your property that is open to environmental influences before you 
use it, you would need consider the well and the holding pond to be two 
separate water sources (the well would be a ground water source, and 
the holding pond would be a surface water source). Where water testing 
requirements apply, they apply

[[Page 74452]]

to each water source individually. There is no difference in testing 
requirements based on whether the water is used for multiple 
commodities, or applied over non-contiguous fields. We realize that the 
testing requirements may be particularly challenging for farms that 
have multiple agricultural water sources and we encourage farms to 
provide us with details of their specific situations so that we can 
consider flexible approaches to testing multiple sources.
    Section 112.42(a) requires you to inspect your water distribution 
systems to the extent that they are under your control, including 
considering different factors identified in (a)(1) through (a)(5). 
Therefore, for example, provided you have inspected your water 
distribution systems in compliance with Sec.  112.42 and you have 
determined there is no additional exposure to potential contamination 
along your distribution system from your ground water to the sprinkler 
heads, collecting water samples from the ground water would 
sufficiently represent your water source such that you would not need 
to additionally collect water samples at the sprinkler head(s). This 
rule is not prescriptive about the exact point of collection of water 
samples when testing is required, but it requires that all water 
samples must be representative of your use of the water (see Sec.  
112.46(b) and (c)).
5. Minimum Number of Samples for Initial Survey (Sec.  
112.46(b)(1)(i)(A)) and/or Annual Survey (Sec.  112.46(b)(2)(i)(A)) 
Related To Testing of Untreated Surface Water Used in a Direct Water 
Application Method During Growing Activities
    (Comment 238) Some comments oppose the proposed minimum number of 
samples required for the proposed baseline and annual surveys for 
untreated surface water used in a direct water application method 
during growing activities for covered produce other than sprouts. These 
comments ask that we align the testing frequency requirements with the 
guidelines in USDA GAPs, which according to these comments recommend 
testing three water samples during the growing season.
    (Response) The testing frequency we proposed, and are now 
finalizing in Sec.  112.46(b) for untreated surface water used for 
Sec.  112.44(b) purposes, is based on the minimum number of samples 
needed to do the relevant calculations to characterize the untreated 
surface water source used as agricultural water for purposes of Sec.  
112.44(b), given certain expectations about the variability of that 
source. For untreated surface water sources, where measurements of 
log10 abundance of generic E. coli are expected to exhibit 
an average (population) standard deviation of 0.4, our evaluation 
indicates that when water quality is stable, neither deteriorating nor 
improving over time, a sample size of 20 for initial or for a moving 
window of most recent observations from initial and/or annual surveys 
would provide sufficient precision of estimation of the microbial water 
quality profile (GM and STV of indicator bacteria) to determine 
appropriate conditions of use. In the absence of detailed information 
concerning how frequently changes occur in water quality of surface 
water sources, and what patterns and magnitude of changes are most 
likely, it is not possible to determine a best or optimal frequency by 
which prior data should be replaced by more current survey data within 
a moving window of observations collected over multiple years. However, 
based on an assessment of the magnitude of bias in estimates of 
log10 GM and log10 STV for hypothetical changes 
in population log10 GM, a minimum sample size of 5 for 
annual surveys, being 25 percent of the minimum of 20 samples found to 
be sufficient to determine appropriate conditions of use, provides a 
reasonable degree of compromise between the competing objectives of 
having estimates of the microbial water quality profile sensitive to 
sudden and substantive changes in water quality and minimizing the 
number of samples collected annually when water quality is relatively 
stable and unchanging (Ref. 99). Therefore, we are establishing the 
minimum testing frequencies as 20 samples for the initial survey 
required under Sec.  112.46(b)(1)(i) and 5 samples for the annual 
survey required under Sec.  112.46(b)(2)(i). To provide flexibility and 
account for sources of water that have less variability in their 
quality than that assumed in our calculations, we are providing for the 
use of an alternative testing frequency in lieu of the required minimum 
number of samples, in Sec.  112.49(c) and (d), provided the conditions 
in Sec.  112.12 are met. With respect to comments about USDA's GAP 
guidelines, we plan to work with USDA as they update their GAPs audit 
program to align with the requirements of the produce safety 
regulation.
    (Comment 239) Several comments state that the proposed minimum 
number of 20 samples for the proposed baseline survey, under proposed 
Sec.  112.45(b)(1)(ii), is excessive, too stringent, and/or does not 
take into consideration critical site-specific variables of surface 
waters. Comments also point out that the 20-sample minimum requirement 
is a statistical construct, and argue that it was not selected as an 
indicator of food safety, arguing that the time and location of 
sampling are far more important than the number of samples. Others 
contend that 20 samples over two years would be burdensome or 
impracticable for certain commodities or in certain regions. For 
example, one comment states that the proposed frequency is not 
practicable in the mid-Atlantic States, where the commenter notes 
overhead irrigation is often used fewer than ten times per year, 
depending on the crop. This commenter also points out strawberry farms 
often only apply overhead irrigation as frost control one to three 
times per season, and crops are often rotated and farms may change 
water sources every three to four years. Similarly, another comment 
argues that the proposed 20-sample minimum would be impracticable for 
certain crops, such as cherries and berries, which have a harvest 
period of approximately 20 days. Another comment recommends that 
baseline characterization should be done once a month during the 
growing season with a minimum of three times per season, but that the 
required testing frequency should never be greater than the frequency 
of irrigation. Still other comments that suggest aligning the frequency 
for baseline characterization for untreated surface water with that for 
untreated ground water, recommend requiring testing at least four times 
during the growing season or over a period of 1 year, using a minimum 
total of four samples. These comments argue that four tests for 
untreated surface water, particularly when based on effective sample 
collection (e.g., time of day, depth, and at high or low flow of 
water), provide an appropriate range for farms to use in establishing 
the profile of their water quality.
    (Response) As previously explained, a sample size of 20 for the 
initial survey for untreated surface water used in a direct application 
method is the minimum necessary to provide sufficient precision of 
estimation of the microbial water quality profile to determine and 
verify appropriate conditions of use of the water based on certain 
expectations about the average variability of log10 E. coli 
abundance (Ref. 99). Therefore, we are retaining the requirement for a 
minimum sample size of 20 samples in Sec.  112.46(b)(1)(i)(A). However, 
we acknowledge the concerns commenters raised about the 
impracticability of collecting 20 samples

[[Page 74453]]

in 2 years, as the water is used during growing activities using a 
direct water application method and collected as close in time as 
practicable to, but prior to, harvest, particularly for certain 
commodities or irrigation practices where the time period of direct 
application of agricultural water is short or variable. The minimum 20 
samples for the initial survey are required to be collected over a 
minimum (not maximum) of 2 years such that, in the circumstances where 
direct application periods are short, you may collect your samples over 
more than 2 years. We believe a minimum period of 2 years is necessary 
to provide an adequate representation of the microbial quality of 
agricultural water to enable informed decisions about its use in a 
direct application method. However, we are also adding a requirement 
that the 20 samples for the initial survey must be collected within a 
time period not greater than 4 years. This limitation on the use of 
older data is intended to ensure that the data used adequately 
represent the current microbial quality of your untreated water source. 
Therefore, you may collect your water samples for the initial survey 
over a period of four years to make up the minimum sample size of 20 
samples to then establish your microbial water quality profile. We 
expect that farms will use this option to collect initial survey 
samples over more than 2 years and up to 4 years in circumstances with 
short timeframes for direct application of agricultural water, for 
example.
    (Comment 240) One comment recommends the necessary number of 
samples for the proposed baseline survey should be based on a study of 
available historical data on quality of that water source.
    (Response) As previously explained, we conclude a minimum sample 
size of 20 samples is necessary for the initial survey, assuming a 
standard deviation of 0.4 (of log abundance of E. coli). If you have 
evidence the microbial quality of your untreated surface water source 
is less variable than that assumed in our calculations, including based 
on your historical data (provided such data are representative of the 
current quality of your water and were gathered within the previous 
four years), you may be able to use a testing frequency that is lower 
than that required in Sec.  112.46(b)(1)(i)(A) or Sec.  
112.46(b)(2)(i)(A). To account for such circumstances, we are providing 
for the use of an alternative testing frequency in lieu of the required 
minimum number of samples (see Sec. Sec.  112.49(c) and (d) and 
112.12).
    (Comment 241) Some comments state the proposed minimum 20 samples 
for baseline survey for each untreated surface water source would be 
economically burdensome, especially for small farms, with no 
appreciable increase to produce safety. These comments also contend 
that reducing the testing frequency (and thereby reducing the 
significant burden on small farmers) would be consistent with the 
public health goals of the rule.
    (Response) See our response to Comment 235 where we explain our 
rationale for the minimum testing frequencies we are establishing in 
Sec.  112.46(b)(1)(i)(A) for the initial survey. We intend to work with 
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. Moreover, we are providing for extended compliance periods 
of an additional 2 years each for covered activities involving covered 
produce (except sprouts), which results in compliance periods of 6 
years for very small farms, 5 years for small farms, and 4 years for 
all other farms for compliance with certain water provisions, Sec.  
112.46(b) among them (except Sec.  112.46(a) and (b)(1) with respect to 
untreated surface water sources) as explained in response to Comment 
240 and in section XIII.K of this document. (See also section XXIV for 
compliance dates for covered activities involving sprouts, which are 
subject to all of part 112 including subpart M). We also have included 
certain size-based provisions, including a coverage threshold and a 
qualified exemption described in Sec. Sec.  112.4 and 112.5.
    (Comment 242) Several comments oppose the minimum sample size of 
five samples for the annual survey, under proposed Sec.  
112.45(b)(2)(i), stating that such a frequency of testing is 
unnecessary, burdensome, and not scientifically determined. These 
comments suggest different acceptable minimum samples sizes ranging 
from three samples annually (along with a request to align with USDA 
GAPs guidelines) to one sample annually.
    (Response) See our response to Comment 238 where we explain our 
rationale for the minimum testing frequency we are establishing for the 
annual survey in Sec.  112.46(b)(2)(i)(A) and our intent to work with 
USDA as they update their GAPs audit program to align with the 
requirements of the produce safety regulation.
6. Use of Historical Data for Testing Untreated Surface Water Used in a 
Direct Water Application Method During Growing Activities (Sec.  
112.46(b))
    (Comment 243) Some comments note farms currently conduct water 
testing (including, for example, consistent with relevant industry 
guidelines) and maintain these historical data, and ask that these 
farms be allowed to use such data in their baseline survey to establish 
the water quality profile. Comments also request FDA to clarify that 
farms would be able to start collecting samples immediately on 
publication of the final produce safety rule to allow sufficient time 
to conduct the proposed baseline survey.
    (Response) To develop the microbial water quality profile required 
under Sec.  112.46(b)(1) for untreated surface water used in growing 
covered produce other than sprouts using a direct water application 
method, covered farms are required to conduct an initial survey over a 
minimum period of 2 years and not greater than 4 years, using a minimum 
total of 20 samples. We do not expect farms to incur additional 
sampling costs to satisfy the initial survey requirement in Sec.  
112.46(b)(1), if they already possess sufficient microbial water 
quality data (consisting of the minimum required number of samples) 
collected in the manner required under Sec.  112.46(b). Under these 
circumstances, a farm is permitted to use available historical 
microbial water quality data, from the previous four years, to make up 
the minimum 20 samples to calculate the current microbial water quality 
profile. Moreover, covered farms will have an additional 2 years, i.e., 
a total of 4 to 6 years, depending on farm size, from the effective 
date of this rule for compliance with the water testing provisions in 
Sec.  112.46, except Sec.  112.46(a) and (b)(1) with respect to 
untreated surface water, for covered activities involving covered 
produce (except sprouts).
    We exclude Sec.  112.46(b)(1), with respect to untreated surface 
water only, from the 2-year extended compliance period provided for the 
remainder of Sec.  112.46 because, in order to comply with the 
microbial quality criteria in 112.44(b), farms must have developed a 
microbial water quality profile based on the initial survey conducted 
over a minimum of 2 years and not greater than 4 years. Accordingly, to 
develop the microbial water quality profile prior to the point at which 
they must comply with all of the requirements of subpart E, covered 
farms must begin water sampling and subsequent testing not later than 4 
years after issuance of this

[[Page 74454]]

rule for very small farms; not later than 3 years after issuance of 
this rule for small farms; and not later than 2 years after issuance of 
this rule for all other farms. If they choose to, a farm that is not 
small or very small can begin water sampling and subsequent testing as 
early as when this rule is published, and expect to use those test 
results to comply with the rule by the compliance date. Initiating 
water sampling upon publication of this rule will allow those covered 
farms to collect 5 samples per year over the next four years, 
sufficient to make up the minimum 20 samples necessary to develop the 
microbial water quality profile required under Sec.  112.46(b) at the 
point at which they must comply with all of the requirements of subpart 
E. On the other hand, if these covered farms initiate water sampling 
two years after issuance of this rule, the farms will need to collect 
10 samples per year over the next two years to make up the minimum 20 
samples necessary to develop the microbial water quality profile. In 
either instance, the covered farms will have sufficient time to develop 
a microbial water quality profile and determine the appropriate way(s) 
in which to use water from that source based on that profile, in 
accordance with Sec.  112.45(b)(1) through (b)(3). Covered farms that 
are small and very small may decide not to begin testing upon issuance 
of this rule with the expectation of using those test results at their 
compliance date because they are not required to have established the 
microbial water quality profile under Sec.  112.46(b) until 5 and 6 
years, respectively, after the effective date of this rule and because 
farms must use data that are no more than 4 years old to establish 
their microbial water quality profile. We are not similarly excluding 
Sec.  112.46(b)(1) with respect to untreated ground water from the 
extended compliance period because the amount of time needed for the 
initial survey for such sources is significantly shorter (compare Sec.  
112.46(b)(1)(i)(A) and (B)).
    Note that the exclusion of Sec.  112.46(b)(1) with respect to 
untreated surface water from the extended compliance period does not 
mean that covered farms must bring untreated surface water used for 
Sec.  112.44(b) purposes into compliance with that microbial quality 
requirement within the 2-4 year compliance period (depending on farm 
size) applicable to the remaining provisions of this rule. Rather the 
exclusion is intended to ensure that covered farms will begin 
collecting and testing samples and obtain data to develop the microbial 
water quality profile necessary to then comply with the remainder of 
the water requirements, for which the extended compliance period of 4 
to 6 years (depending on farm size) applies.
    We are also excluding Sec.  112.46(a) from the extended compliance 
period because this provision provides an important exception to the 
testing requirements in Sec.  112.46(b)(1) and is referenced therein. 
Section 112.47 is also subject to the shorter compliance period because 
it establishes requirements that are relevant to testing requirements 
when they become applicable.
    We are not similarly providing extended compliance periods for 
these specified water requirements, in the case of covered activities 
involving sprouts, as discussed in section XVIII.J of this document. 
Therefore, covered farms must comply with all of the applicable 
requirements of part 112, including subpart E, for all covered 
activities involving sprouts, within one to three years of the 
effective date of the rule, depending on the size of the farm. See also 
section XXIV for additional information.
7. Updating the Microbial Water Quality Profile Annually for Water Used 
in a Direct Water Application Method During Growing Activities (Sec.  
112.46(b)(2))
    In the supplemental notice, we acknowledged that there are certain 
limitations to our proposed tiered approach, particularly regarding 
whether and how annual verification data may be used to identify the 
need for changes to water use practices in the current season and/or 
the need for a new water quality profile. For example, we asked if 
there is a threshold based on magnitude of deviation indicated in an 
annual survey that would suggest that the existing water quality 
profile is no longer representative of the current water quality.
    (Comment 244) Some comments disagree that water quality profiles 
should be re-characterized every ten years, as would have been required 
under proposed Sec.  112.45(b)(1)(iii)(A), and, instead, recommend 
applying a rolling set of samples such that the water quality profile 
is updated on an ongoing basis. Similarly, one other comment recommends 
eliminating the concept of a baseline water quality profile followed by 
an annual verification survey, in favor of a rolling geometric mean 
coupled with appropriate guidance on steps to take when a test exceeds 
a threshold limit; however, this commenter did not further specify what 
such threshold limit should be. One comment states that a single high 
test result should be followed-up by retesting to confirm the previous 
finding and rule out a potential false positive. Another comment finds 
it unclear whether and when the water quality profile would need to be 
re-characterized based on annual survey test results.
    (Response) We are making several revisions to our proposed baseline 
and annual survey provisions to simplify the requirements related to 
developing a new or updated microbial water quality profile, while 
retaining the advantages of the tiered approach proposed in the 
supplemental notice. We are also combining the testing provisions for 
untreated surface water and untreated ground water sources used for 
direct water application during growing covered produce other than 
sprouts into the same provision (Sec.  112.46(b)).
    We are revising our tiered approach to testing by, first, 
eliminating (1) the proposed requirement to develop a new water quality 
profile at least once every 10 years (proposed Sec.  
112.45(b)(1)(iii)(A)); and (2) the proposed requirement that, if the GM 
and/or STV values of the annual survey samples do not support your 
water quality profile and therefore your existing water use as 
specified in Sec.  112.44(c), you must develop a new water quality 
profile (proposed Sec.  112.45(b)(2)(ii)).
    Second, in lieu of the eliminated provisions, we are adding these 
revised requirements in final Sec.  112.46(b)(2): (1) Following the 
development of the microbial water quality profile based on an initial 
survey, you must test water annually to update your existing microbial 
water quality profile to confirm that the way(s) in which the water is 
used continues to be appropriate. You must analyze a minimum number of 
five samples per year (for untreated surface water) or one sample per 
year (for untreated ground water). These samples must be representative 
of your use of the water and must be collected as close in time as 
practicable to, but prior to, harvest (Sec.  112.46(b)(2)(i) and (ii)); 
and (2) To update the microbial water quality profile, you must 
calculate revised GM and STV values using your current annual survey 
data, combined with your most recent initial or annual survey data from 
prior years, but within the previous 4 years, to make up a rolling data 
set of at least 20 samples (for untreated surface water) or 4 samples 
(for untreated ground water) (Sec.  112.46(b)(2)(iii)); and (3) You 
must modify your water use, as appropriate, based on the revised GM and 
STV

[[Page 74455]]

values in your updated water quality profile, in accordance with Sec.  
112.45(b)(1) through (3) (Sec.  112.46(b)(2)(iv)), as soon as 
practicable, and no later than the following year.
    This revised approach, which relies on an annually updated 
microbial water quality profile comprised of rolling GM and STV values, 
has several advantages compared to the approach proposed in the 
supplemental notice. It maintains the advantages of the tiered approach 
proposed in the supplemental notice compared to the originally proposed 
approach in the 2013 proposed rule in that it reduces the required 
frequency of testing compared to the originally proposed requirements. 
It also maintains the flexibility of the tiered approach by allowing 
farms to make decisions about safe use of available water sources as 
soon as practical, but no later than the following year, as well as 
adjusting testing frequencies based on long-term test results. In 
addition, unlike the approach in the 2013 proposed rule, use of GM with 
accompanying STV values eliminates the need for a single sample maximum 
threshold, while accounting for variability of water quality and 
occasional high sample results that could highlight potential risk 
associated with use of the water. Moreover, the revised approach 
established in Sec.  112.46(b) eliminates the need for specific 
thresholds based on annual verification survey data to determine 
whether and when a new microbial water quality profile is needed 
(using, for example for untreated surface water sources, previous 
years' 15 samples versus a complete new set of 20 samples).
    Under this revised approach, codified in Sec.  112.46(b), covered 
farms must develop an updated microbial water quality profile, 
consisting of revised GM and STV values based on each year's annual 
survey of a minimum of 5 samples or 1 sample (for untreated surface 
water, or untreated ground water, respectively) plus the data of the 
most recent 15 samples or 3 samples (for untreated surface water, or 
untreated ground water, respectively) collected within the previous 4 
years to make up the minimum 20 samples or 4 samples (for untreated 
surface water, or untreated ground water, respectively) necessary to 
establish the GM and STV values. Under this approach, the microbial 
water quality profile is continually updated on an annual basis so that 
changes in the water quality can be identified to inform any necessary 
modifications to practices. You must make those modifications to 
practices as soon as practical, and no later than the following year. 
If you are aware, based on your GM and STV, that you need to make 
modifications in your water use practices and it is practicable for you 
to make those modifications for the crop in the field at the time you 
receive your test results, at your next harvest if you have multiple 
harvests of a crop, or during the next growing season if you have 
multiple growing seasons within a calendar year, you must do so. If 
none of these timeframes are practicable or applicable to your 
operation, you must make the modifications to your water use practices 
no later than the following year.
    This approach also alleviates the complexity around determining 
when to re-characterize the microbial water quality profile. For 
example, if a single crop farm with a single surface water source 
calculates the GM of 20 untreated surface water samples at the end of 
the growing season in year 3 to be 126 CFU generic E. coli/100 mL and 
the STV of 20 samples to be 300 CFU generic E. coli/100 mL, and then 
determines the updated GM at the end of the growing season in year 4 to 
be 200 CFU generic E. coli/100 mL and his STV to be 450 CFU generic E. 
coli/100 mL, the farm can adjust its practices for year 5, such as to 
include a 1 day die-off interval, reflecting the change in the water 
quality profile. In year 5, the farm finds the GM to be 230 CFU generic 
E. coli/100 mL, and STV to be 460 CFU generic E. coli/100 mL. No 
further mitigation strategy (beyond the 1 day die-off interval) is 
required in this scenario from the previous year, because the farm's 
existing practices reflect the required mitigation strategies to 
achieve the microbial water quality criteria in Sec.  112.44(b). While 
the GM and STV do not match exactly those from the previous year, the 
farm recognizes that its mitigation strategies are still sufficient to 
meet the Sec.  112.44(b) criteria, and so does not have to make changes 
to its current water use. We believe that annually-updated, rolling GM 
and STV calculations address commenters' concerns about false positives 
or single high test results, by allowing any high data to be 
incorporated into the long-term profile.
    As another example, a diversified farm growing multiple crops per 
year using a surface water source for direct water application measures 
the GM at the end of the growing season for the first crop of the 
season in year 3 to be 150 CFU generic E. coli/100 mL and the STV to be 
400 CFU generic E. coli/100 mL of agricultural water. The STV achieves 
the microbial water quality criteria, but the GM exceeds the criteria 
of 126 CFU generic E. coli/100 mL. The farm calculates the values for 
the microbial water quality profile prior to the harvest of the second 
crop of the year, and is therefore able to adjust the growing practices 
for the harvest of this crop to provide 1 day of microbial die-off 
between last irrigation and harvest to achieve the specified GM of the 
microbial water quality criteria.
    The GM and STV are sensitive to extremes among individual sample 
measurements and a sufficiently high level (spike) in even one sample 
can elevate the GM (and/or STV) over the microbial quality criteria in 
Sec.  112.44(b). For example, a grower calculates his/her microbial 
water quality profile and find that the GM is 118 CFU generic E. coli 
per 100 mL, and the STV is 140 CFU generic E. coli per 100 mL. In the 
next year the grower collects five new samples as part of the annual 
survey and the sample results include 95, 147, 96, 6,000 and 137 CFU 
generic E. coli per 100 mL. These values are rolled into the previous 
year's microbial water quality profile, and it now includes the latest 
five samples. The updated microbial water quality profile has a GM of 
143 CFU generic E. coli per 100 mL, and STV of 448 generic E. coli per 
100 mL. The grower uses this information to apply a one-day die-off 
period between last irrigation and harvest, as soon as practicable, but 
no later than the following year. This sensitivity is one of the 
reasons we believe that the rolling GM and STV calculations are the 
appropriate tool for determining microbial water quality while 
protecting public health. We realize that farms have concerns about 
single high samples and we encourage farms to treat each sample as a 
marker in the variability of the water source to identify trends over 
long periods of time. This approach will help covered farms understand 
how their water sources may vary in the long term.
    Even though we are finalizing a rolling GM and STV measurement so 
covered farms can develop a microbial water quality profile over time, 
we are also retaining the requirement, in Sec.  112.46(b)(3), that if 
you have determined or have reason to believe that your microbial water 
quality profile no longer represents the quality of your water (for 
example, if there are significant changes in adjacent land use that are 
reasonably likely to adversely affect the quality of your water 
source), you must develop a new microbial water quality profile 
reflective of the time period at which you believe your microbial water 
quality profile changed. To develop a new microbial water quality 
profile, you must calculate new

[[Page 74456]]

GM and STV values, using your current annual survey data (if taken 
after the time of the change), combined with new data, to make up a 
data set of at least 20 samples or 4 samples (for untreated surface 
water, or untreated ground water, respectively). You must then modify 
your water use based on the new GM and STV values in your new microbial 
water quality profile in accordance with Sec.  112.45(b) (see Sec.  
112.46(b)(3)).
8. Testing Highly Variable Untreated Surface Water Sources
    (Comment 245) In the supplemental notice, we requested comment on 
whether, for a highly variable water source (e.g., a moving water 
body), we should require more than a five-sample annual verification 
survey. Some comments oppose increasing the sampling frequency, stating 
that most, if not all, surface water sources would qualify as a 
``moving water body.'' In addition, comments argue if a water source 
does not consistently achieve the proposed GM and STV standard because 
of uncontrolled variability, an increased frequency of testing would 
not achieve compliance. These comments suggest, in such instances, the 
farm should acknowledge the uncontrolled variability and implement 
proposed mitigation measures, rather than test more frequently.
    (Response) We are not establishing water testing requirements 
specific to highly variable untreated surface water sources. Rather, 
under our revised approach established in Sec.  112.46(b), such water 
sources would be subject to the same testing requirements as all other 
untreated surface water used during growing of covered produce (other 
than sprouts) using a direct water application method. We have 
incorporated flexibility in the requirements in Sec.  112.46(b) to 
allow farms to independently determine, in compliance with Sec. Sec.  
112.49(c) and (d) and 112.12, the appropriate number of samples 
required to characterize an untreated surface water source based on 
their knowledge of the water system, its inherent variability, and the 
vulnerability of their water source to contamination. The untreated 
surface water testing requirements are used to inform the appropriate 
use of the water source, by accounting for the variability of the 
source. Therefore, you must first characterize the microbial water 
quality of the water source by testing in accordance with Sec.  
112.46(b) and developing a microbial water quality profile. If the GM 
or STV do not meet the microbial quality criteria in Sec.  112.44(b), 
then you must consider and implement the options provided in Sec.  
112.45(b)(1) through (b)(3), as appropriate for your commodity and 
practices and conditions on your farm.
9. Follow-Up Actions Based on Water Testing Results or Other 
Information (Sec. Sec.  112.45 and 112.46)
    (Comment 246) Some comments state that FDA did not clearly outline 
the actions a covered farm must take under the tiered testing approach 
for untreated surface water. For example, comments ask for 
clarification about the steps a farm must take if the annual test 
results indicate a change in microbial water quality and do not confirm 
the baseline water quality profile. Some comments also request 
clarification of necessary actions if the test results are not 
available prior to harvest and additional storage die-off rates and/or 
appropriate microbial removal rates have not been developed. Some 
comments also point out the proposed provisions do not provide an 
exception for circumstances where a high positive finding is later 
corrected and confirmed to be within the established water quality 
profile.
    (Response) With the revisions we have made to Sec.  112.46(b), you 
will have a rolling microbial water quality profile consisting of 20 
samples for untreated surface water sources (e.g., 5 samples from your 
annual survey and the most recent 15 samples, taken within the last 4 
years) or 4 samples for untreated ground water sources (e.g., 1 annual 
sample and the most recent 3 from within the last 4 years). From this 
data set, you will update the GM and STV values each year. If the GM 
and STV do not meet the microbial quality criteria in Sec.  112.44(b), 
you must take actions in accordance with Sec.  112.45(b). See also 
discussion in Comment 214 regarding taking action at your next harvest 
or in the next growing season, if more immediate changes are not 
practicable.
    We appreciate the concerns of commenters seeking additional 
information and clarification on follow-up corrective measures that are 
required under the different provisions, including in response to 
results of testing required in Sec.  112.46 and/or in response to your 
knowledge or determination that water is not safe or of adequate 
sanitary quality and/or does not meet the microbial quality criteria in 
Sec.  112.44. We discuss some examples in the paragraphs that follow.

    Example 1: Knowledge of Upstream Change in Conditions--A 
concentrated animal feeding operation (CAFO) is established upstream 
and is discharging untreated wastewater into your water source. In 
this example, a farmer uses water from a stream for direct water 
application method irrigation during growing covered produce that is 
not sprouts. The farm has established a water quality profile for 
the stream over the years and is using the water from the stream in 
compliance with the relevant provisions of the rule. The farm now 
learns that a CAFO has started operation upstream from the farm and 
within a close distance and is regularly discharging untreated 
wastewater into its water source. The farm has reason to believe 
that its microbial water quality profile no longer represents the 
quality of the water from the stream. This is because, under the 
circumstances, the addition of the CAFO upstream and its regular 
discharge of untreated wastewater is a significant change in nearby 
land use that is reasonably likely to adversely affect the quality 
of the water source. Thus, under Sec.  112.46(b)(3), the farm must 
develop a new microbial water quality profile reflective of the time 
period at which the farm believes the microbial water quality 
profile changed. In this case, the farm's new microbial water 
quality profile must reflect only data from after the time the CAFO 
began operation upstream. The farm must take new samples of the 
water, combined with as many test results as it already has from its 
previous data set from samples taken after the CAFO began 
operations, to make up a data set of at least 20 samples, and 
calculate new GM and STV (the new water quality profile) from that 
data set. Then the farm must modify its water use based on the new 
GM and STV values in its new microbial water quality profile in 
accordance with Sec.  112.45(b).
    Example 2: Knowledge of Likely Contamination Event--Dead deer in 
stream. In this example, as in Example 1, a farmer uses water from a 
stream for direct water application method irrigation during growing 
covered produce that is not sprouts. The farm has established a 
microbial water quality profile for the stream over the years and is 
using the water from the stream in compliance with the relevant 
provisions of the rule. During the growing season, the farm finds 
deceased and decaying deer in the area of the stream under the 
farm's control, upstream from where the farm draws its water and at 
a close distance. The farm now has reason to believe that its 
agricultural water is not safe or of adequate sanitary quality for 
its intended use as required under Sec.  112.41 because the water is 
reasonably likely to contain human pathogens transferred by the dead 
and decaying deer. Therefore, under Sec.  112.45(a), the farm must 
immediately discontinue using the water for irrigation until it 
completes one of the actions described in Sec.  112.45(a). The 
approach that the farm is most likely to take (as most likely the 
most feasible option) is to re-inspect the entire affected 
agricultural water system to the extent it is under the farm's 
control, identify any conditions that are reasonably likely to 
introduce known or reasonably foreseeable hazards into or onto 
covered produce or food-contact surfaces, make necessary changes, 
and take adequate measures to determine if the changes were 
effective (Sec.  112.45(a)(1)). In this case, that would entail, at 
a minimum: re-inspecting the entire water system potentially 
affected by the dead deer to the extent it is under the farm's 
control to identify any relevant

[[Page 74457]]

conditions (such as additional dead deer, including carcass 
materials that may have contaminated the farm's water distribution 
system if applicable); removing the dead deer and any related 
hazards identified during the re-inspection; cleaning any necessary 
equipment that may have been contaminated (such as the water 
distribution system impacted by the deer); and visually verifying 
that all carcass materials have been removed. Once the farm has 
taken all of the appropriate steps in light of its specific 
circumstances, it may resume using the water for direct water 
application irrigation of its covered produce.
    Example 3:  Exceedance of no detectable generic E. coli 
criterion in Sec.  112.44(a) in water used for hand-washing and 
rinsing produce during and after harvest. In this example, a farmer 
uses water drawn directly from a properly protected well that 
qualifies as an untreated ground water source for hand-washing and 
rinsing produce during and after harvest. The farm has tested the 
well over the years and is using the water from the well in 
compliance with the relevant provisions of the rule (in this 
example, the farm has never detected generic E. coli in the well 
water before). This year, the farm conducts its annual test of the 
well water, taking a sample that is representative of the intended 
use (in this case, taken during the time the farm is using the water 
for hand-washing and produce rinsing), and detectable generic E. 
coli is found, thus exceeding the required criterion in Sec.  
112.44(a). Under Sec.  112.45(a), the farm must immediately 
discontinue using the water for hand-washing and produce rinsing and 
may not re-use it for those purposes until it completes one of the 
actions described in Sec.  112.45(a). The farm's choices are to re-
inspect the entire affected agricultural water system to the extent 
it is under the farm's control, identify any conditions that are 
reasonably likely to introduce known or reasonably foreseeable 
hazards into or onto covered produce or food-contact surfaces, make 
necessary changes, and take adequate measures to determine if the 
changes were effective (Sec.  112.45(a)(1)), or to treat the water 
in accordance with Sec.  112.43 (Sec.  112.45(a)(2)). The farm may, 
of course, also choose to use a different water source that does 
meet the microbial quality criterion in Sec.  112.44(a) for hand-
washing and rinsing of produce either permanently or while it 
pursues these corrective actions. The farm may not use untreated 
surface water for these purposes (see Sec.  112.44(a)). If the 
circumstances allow the farm to use Sec.  112.45(a)(1) to correct 
the problem (for example, if a fixable problem is identified with 
respect to the farm's affected water distribution system that the 
farm is able to adequately correct in compliance with that 
provision), a required aspect of compliance with this provision 
under the circumstances is to re-test the water to adequately ensure 
that it now meets the microbial quality criterion in Sec.  112.44(a) 
(see Sec.  112.45(a)(1)). Making necessary changes to address the 
identified conditions (as required by Sec.  112.45(a)(1)) also 
includes steps such as cleaning affected food contact surfaces, for 
example. Moreover, under Sec.  112.46(c), the farm must also test 
the well at least four times per growing season or year in the next 
year because of the test result that failed to meet the microbial 
quality criterion in Sec.  112.44(a). If all four tests in the next 
year meet the criterion, the farm may switch back to testing once 
per year.
    Example 4: Exceedance of GM/STV generic E. coli criteria in 
Sec.  112.44(b). In this example, a farmer uses water from a stream 
for direct water application method irrigation during growing 
covered produce that is not sprouts. The farm has established a 
water quality profile for the stream over the years and is using the 
water from the stream in compliance with the relevant provisions of 
the rule. In past years, the GM and STV calculated using the farm's 
test results have been within the bounds of the microbial water 
quality criteria of Sec.  112.44(b) (so no time intervals based on 
microbial die-off, or log reductions based on microbial removal 
rates have been applied). This year, however, the calculation of the 
GM and STV values for the updated microbial water quality profile 
(calculated, in this case, after the harvest has been completed and 
the water is no longer being used for direct water application 
method irrigation) exceed the microbial quality criteria. In this 
case, the covered farm must take actions, as appropriate, based on 
the revised GM and STV values in the updated microbial water quality 
profile, in accordance with Sec.  112.45(b)(1) through (3) as soon 
as practicable, and no later than the following year. The farm's 
practices related to that water use can be modified through applying 
an adequate time interval (in days) between last irrigation and 
harvest in accordance with Sec.  112.45(b)(1)(i); or applying a time 
interval (in days) between harvest and end of storage, or applying a 
calculated log reduction during activities such as commercial 
washing, provided the farm has adequate supporting scientific data 
and information in accordance with Sec.  112.45(b)(1)(ii). If these 
mitigation options are not selected or cannot be appropriately 
applied to achieve the microbial water quality criteria, the farm 
may consider the options in Sec.  112.45(b)(2) or (b)(3), i.e., the 
farm must either re-inspect the entire affected agricultural water 
system to the extent it is under the farm's control and take other 
steps, including make necessary changes and retesting the water to 
determine if the changes were effective and the water now meets the 
criteria; or treat the water in accordance with Sec.  112.43. If 
none of the above mitigation options are selected and appropriately 
applied to achieve the microbial water quality criteria, the farm 
must discontinue using water from that source for direct water 
application method irrigation of covered produce no later than one 
year from the time that the farm determined that the water did not 
meet the required criteria.

    There may be circumstances that allow the farm to use Sec.  
112.45(b)(2) to correct the problem. For example, the farm might 
reasonably determine, under the circumstances, that the change in 
microbial water quality was due to non-recurring point-source 
contamination that can be adequately corrected in compliance with this 
provision. An example of such a finding would be visible damage to a 
water dam on the farm's property (and under the farm's control) 
upstream from where the farm draws its water, where the dam serves to 
reduce water flow by holding back water from a stream that would 
otherwise converge with the stream water the farm uses. The farm might 
reasonably conclude, under these circumstances, that the damage to the 
dam is a correctable, non-recurring point-source of contamination. If 
the farm is able to stop the leak and repair the damaged dam, the farm 
may use Sec.  112.45(b)(2) as a mitigation option. In such cases, a 
required aspect of compliance with this provision under the 
circumstances is to re-test the water after the correction has been 
made to adequately ensure that the water meets the microbial quality 
criteria in Sec.  112.44(b) (see Sec.  112.45(b)(2)). Under Sec.  
112.45(b), the farm in this example has up to a year before it must 
discontinue use of the water for direct application method irrigation 
of covered produce, and post-correction sampling should be conducted 
and analyzed within such time if the farm wishes to continue using the 
water for this purpose without interruption. We note that to meet the 
requirements of Sec.  112.46(b)(2) for the annual survey, samples must 
be representative of your use of the water and must be collected as 
close in time as practicable to, but prior to, harvest. However, we 
also encourage farms in such situations to voluntarily conduct 
additional sampling earlier (such as immediately post-correction, even 
if not close in time to harvest) as may be appropriate.
    In rare situations such as that described in this example, the farm 
need not include in its rolling dataset of 20 samples for calculation 
of the GM and STV the set of 5 samples that caused the exceedance, 
leading it to re-inspect, find, and correct the non-recurring point 
source contamination. In this rare situation the data set should be 
made up only of samples that are not reasonably likely to have been 
affected by the non-recurring point-source contamination. With respect 
to calculations for the microbial water quality profile, we encourage 
farms in such situations to take more than the minimum 5 samples in the 
following year(s), because doing so would make it unnecessary to 
include data older than 4 years in the microbial water quality profile. 
However, because the circumstances in which you need not include the 
samples that caused the exceedance in your microbial water

[[Page 74458]]

quality profile are likely to be rare (i.e., we consider that such 
situations most likely only involve non-recurring point-source 
contamination that can be immediately eliminated), we intend to 
exercise enforcement discretion with respect to the 4 year limitation 
in Sec.  112.46(b)(2)(iii) in such situations. This would allow the 
farm in this example to make up its microbial water quality profile in 
the following year using its new annual survey data, combined with its 
most recent initial or annual survey data (not including the samples 
that caused the exceedance), to make up a rolling data set of 20 
samples.
    (Comment 247) One comment argues the proposed water testing 
approach fails to respond to significant changes in water quality in a 
timely manner. Similarly, another comment points out the proposed 
approach for testing untreated surface water reflects a retrospective 
testing scheme, where results of water testing may not be available in 
time to take actions on the harvested produce because the harvested 
produce may already be in commerce by the time the analysis is 
completed and the farm receives the results.
    (Response) The goal of our framework for testing of agricultural 
water that is used for direct water application during growing 
activities for covered produce other than sprouts is to establish a 
microbial water quality profile to help covered farms characterize 
their water sources, understand the variability of those sources, and 
make appropriate long-term decisions about the use of that water for 
the specific purpose of direct water application during growing. As 
explained in response to Comment 180, our framework for the microbial 
quality criteria for water used in direct water application coupled 
with our decision to test for generic E. coli as an indicator organism 
means that exceeding the microbial water quality criteria in Sec.  
112.44(b) does not result in a determination that, based on this 
testing in and of itself, the produce is adulterated. Therefore, the 
follow-up actions listed in Sec.  112.45(b) that must be taken when the 
microbial water quality criteria in Sec.  112.44(b) are not met involve 
longer-term decisions (rather than the immediate decisions required 
under Sec.  112.45(a)) about the use of that water as soon as 
practicable (considering crop in the field, next harvest, or next 
growing season), and no later than the following year. Given the 
logistical realities of sampling and testing close to harvest, there 
may not be time for a farm to adjust water use practices for the 
current year's crop because they may not receive test results in 
sufficient time to take actions related to that crop (for example, test 
results may not be received until after the crop is out of the field 
and into distribution). However, the point of this testing is to 
develop a long-term strategy to ensure that covered farms understand 
the quality of their water, pay attention to changes (such as the 
establishment of a CAFO upstream) that may affect water quality, and 
make appropriate decisions going forward about use of that water. 
Regardless, if the farm has reason to believe that its agricultural 
water is contaminated such that it would render the produce adulterated 
under section 402 of the FD&C Act (e.g., a finding of a pathogen in 
dump tank water), the farm must take appropriate actions to ensure that 
affected food does not enter commerce.
    Under our framework where the microbial quality criteria in Sec.  
112.44(b) and the corresponding testing scheme in Sec.  112.46(b) serve 
as a long-term strategy to help covered farms to understand the quality 
of their water sources and plan the appropriate use of water from those 
sources accordingly, and in light of the options for corrective 
measures in Sec.  112.45(b)(1) through (b)(3), a requirement to 
immediately implement corrective actions on the current crop during 
growing or harvested crop solely based on the results of Sec.  
112.46(b) is not warranted. Rather, we conclude the general requirement 
in Sec. Sec.  112.41 and corresponding 112.45(a) sufficiently address 
those circumstances and necessary immediate actions when water is not 
safe or of adequate sanitary quality for its intended use.

H. Sharing of Water Testing Data (Sec.  112.47(a))

    (Comment 248) One comment requests that FDA provide for the 
establishment of water quality profiles for common water sources 
affecting various farms in a specific geographic area or region.
    (Response) Section 112.47(a)(2) explicitly allows data sharing 
under certain circumstances. However, we do not expect that it will 
typically be possible to develop water quality profiles as described 
under Sec.  112.46(b) on a regional basis for large water sources such 
as rivers. As provided in Sec.  112.47(a)(2), you may use data 
collected by a third party or parties only if the water source(s) 
sampled by the third party or parties adequately represent your 
agricultural water source(s) and all other applicable requirements of 
the rule are met. As explained in the supplemental notice (79 FR 58434 
at 58455), a water source sampled by a third party adequately 
represents your water source if the third party takes its samples from 
the same water source you use (e.g., the same river), and there is no 
reasonably identifiable source of likely microbiological contamination 
(e.g., an untreated sewage discharge point, a source of significant 
amounts of untreated animal feces such as a livestock farm) between the 
point(s) at which the third party collects its samples and the point(s) 
at which you draw the water. Thus, under this provision, testing data 
may only be shared if there is no reasonably identifiable source of 
likely microbiological contamination between the sampling site(s) and 
the farm(s) involved. For a regional water source such as a river, we 
expect that in most cases there will be reasonably identifiable 
source(s) of likely microbiological contamination at various points 
along the river that will prevent all users of the river from sharing 
the same data under this provision. Some users of a river may be able 
to share data under this provision, but only if there are no reasonably 
identifiable source(s) of likely microbiological contamination between 
their sampling point(s) and draw point(s) and all other requirements of 
the rule are met.
    (Comment 249) One comment recommends that FDA work with EPA and 
other agencies to develop and share water testing data with relevant 
parties.
    (Response) To the extent this commenter is referring to water from 
a Public Water System, as defined under EPA's 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 (as defined in 40 CFR 141.2) approved to 
administer the SDWA public water supply program, we note that under 
Sec.  112.46(a)(1), there is no requirement to test any agricultural 
water that is subject to the requirements of Sec.  112.44 when you 
receive water from such a system and you have Public Water System 
results or certificates of compliance that demonstrate that the water 
meets that requirement.
    (Comment 250) Referring to leased lands where an owner may lease a 
field or a portion of the land each year to different farms, one 
comment recommends that, in such cases, the current tenant farmer 
should be able to use the previous tenant farm's water sampling results 
to establish the water quality profile when one is required under 
proposed Sec.  112.45(b), rather than having to conduct a new baseline 
survey.

[[Page 74459]]

    (Response) Under Sec.  112.47(a)(2), you may use test data 
collected by a third party or parties, provided the water source(s) 
sampled by the third party or parties adequately represent your 
agricultural water and all other applicable requirements of the rule 
are met. A water source sampled by a third party adequately represents 
your water source if the third party takes its samples from the same 
water source you use (e.g., the same canal, stream, or reservoir) and 
there is no reasonably identifiable source of likely microbiological 
contamination between the point(s) at which the third party collects 
its samples and the point(s) at which you draw the water. Thus, if a 
farmer of leased land has access to previous years' water testing data 
that meets the requirements of Sec.  112.47(a)(2), the farmer may use 
such data to satisfy relevant testing requirements under Sec.  112.46, 
including those required under Sec.  112.46(b). On the other hand, if a 
farmer of a leased land does not have access to previous years' water 
testing data, or the farmer has access to such data but those data do 
not meet the requirements of Sec.  112.47(a)(2), the farm will need to 
perform its own testing to develop the initial microbial water quality 
profile.

I. Agricultural Water Used During Harvest, Packing, and Holding 
Activities (Sec.  112.48)

    (Comment 251) Some comments state that it would be impossible to 
maintain a potable water standard for postharvest water at all times. 
Comments also state that FDA should include a cost-effective 
recommendation for visual monitoring, and clearer criteria for how 
farms should deal with organic build-up in water and when to change the 
water. Some of these comments also maintain that reliance on visual 
inspection in place of other testing mechanisms may not be safe.
    (Response) Section 112.48(b) requires you to 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). We are including this 
monitoring requirement to highlight conditions that require action, 
such as a water change in a dump tank, and take appropriate measures, 
as necessary. The specific method and criteria for monitoring to 
maintain water quality will need to be operation-specific and, 
therefore, we recommend that you consider establishing protocols 
specific to your harvesting, packing, or holding activity. We note that 
this requirement is not the only requirement applicable to agricultural 
water used for these purposes. Section 112.44(a) establishes a 
microbial quality criterion for such water and prohibits using 
untreated surface water for such purposes. We consider the Sec.  
112.44(a) criterion to apply to the water as it is being added to a 
dump tank, flume, or wash tank. Section 112.45(a) establishes steps 
that a farm must take when the water does not meet the Sec.  112.44(a) 
microbial criterion. In addition, Sec.  112.46(a) establishes the 
circumstances in which water used for the purposes listed in Sec.  
112.44(a) is not required to be tested, and Sec.  112.46(c) requires 
testing untreated ground water used for these purposes. Thus, this rule 
does not rely on visual inspection in place of testing water quality as 
suggested by some comments. Where we have determined that a testing 
requirement is appropriate (i.e., for untreated ground water used for 
these purposes), we have established such a requirement.
    (Comment 252) One comment suggests requiring disinfection treatment 
of re-circulated water used during and after harvest. By contrast, 
another comment states that disinfection of re-circulated water in case 
of dump tanks is unnecessary and impractical.
    (Response) Section 112.48(a) requires you to manage the water used 
during harvest, packing, and holding activities for covered produce as 
necessary, including by establishing and following water-change 
schedules for re-circulated water to maintain the safety and 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). In addition, 
under Sec.  112.44(a), agricultural water applied in any manner that 
directly contacts covered produce during or after harvest activities is 
required to meet the zero detectable generic E. coli in 100 mL 
microbial quality criterion. This requirement applies to the water as 
it is being added to a dump tank, flume, or wash tank (see Comment 
251). Recognizing the wide-range of handling procedures, washing line 
set-ups, and commodity-specific practices where agricultural water 
directly contacts covered produce during or after harvest activities, 
we are not requiring treatment of re-circulated water. Instead, we have 
provided flexibility for farms to implement measures appropriate to 
their practices to comply with Sec.  112.48(a), which may include 
disinfection treatment during re-circulation. See also Comment 196.
    (Comment 253) Some comments express a need for commodity-specific 
research to tailor requirements for the use of water during harvest, 
packing, and holding activities to specific covered produce 
commodities. Some commenters also believe that, although maintaining a 
positive temperature differential between the produce and wash water 
could be a good practice, it may not be practicable based on current 
industry practices. In addition, some commenters do not believe 
applying a water temperature differential has been demonstrated to 
minimize the risk of infiltration of microorganisms.
    (Response) As described in the 2013 proposed rule, water 
temperature can influence processes leading to infiltration of 
microorganisms into many types of produce. In the QAR, too, we noted 
that infiltration of water containing pathogens into produce has been 
demonstrated in apples (Ref. 158), oranges (Ref. 159), tomatoes (Ref. 
160) (Ref. 161), and mangoes (Ref. 162), and was suggested to play a 
role in a 1999 Salmonella outbreak associated with mangoes (Ref. 163). 
In the development of the 2013 proposed rule, we considered proposing a 
specific temperature differential between water and product core 
temperature (e.g., water must be at least 10 [deg]F warmer than core), 
and tentatively concluded that there is insufficient scientific 
evidence supporting the application of such a specific temperature 
differential requirement across all covered produce. Instead, we 
proposed and now finalize Sec.  112.48(c), which requires that 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. Thus, the 
requirement is tailored to apply only to appropriate commodities and 
practices, and only as needed to minimize the potential for 
infiltration of pathogens.
    Although research suggests that water temperature can influence the 
infiltration of microorganisms into various types of produce, including 
apples, oranges, mangoes and tomatoes, other studies demonstrate that 
infiltration can occur without a temperature differential (Ref. 159) 
(Ref. 164). For example, it was demonstrated that internalization of 
Salmonella into tomatoes via their stem scar can occur

[[Page 74460]]

even under a zero temperature differential, and temperature 
differentials up to 10[emsp14][deg]F have no effect on the 
internalization frequency and have limited impact on Salmonella spp. 
cell populations internalized in tomatoes. In addition, 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 spp. in tomatoes (Ref. 164). We did not receive 
data or information in response to the 2013 proposed rule that would 
support a requirement for a specific temperature differential to be 
maintained in agricultural water used during harvest, packing, and 
holding activities across all covered produce.

J. Records Related to Agricultural Water (Sec.  112.50)

    (Comment 254) In response to the 2013 proposed rule, several 
comments support the recordkeeping requirements of proposed Sec.  
112.50, and state that effective water management includes 
recordkeeping that is sufficient to confirm that agricultural water is 
safe throughout the growing season. Comments also agree that farms must 
establish and keep records relating to the findings of the inspection 
of the agricultural water system; the results of any analytical tests 
conducted to determine whether water is safe and of adequate sanitary 
quality for its intended use; and scientific data relied on to support 
the adequacy of methods used to treat agricultural water. One comment 
also agrees with the proposed requirement to maintain annual 
documentation from a public water system, if applicable. Another 
comment suggests that FDA should require documentation of any 
corrective actions that farms employ to address problems identified 
with their water system and to verify that those corrective actions 
were effective.
    (Response) We conclude that certain records are necessary for you 
to ensure your own compliance with the requirements in this rule for 
use of agricultural water, and so that FDA can verify your compliance 
with the relevant requirements of subpart E. We agree that 
documentation of corrective actions is necessary to verify 
effectiveness of the corrective actions and compliance with the 
relevant requirements. In proposed Sec.  112.161(b), we proposed a 
general provision applicable to records required under subparts C, E, 
F, L, and M of part 112 that you must establish and keep documentation 
of actions you take when a standard in any of these subparts is not 
met. For clarification, we are eliminating proposed Sec.  112.161(b) 
and, instead, adding that requirement within the records provisions of 
two relevant subparts, subparts E and M. In subpart E as edited, under 
new Sec.  112.50(b)(6), you must establish and keep documentation of 
actions you take in accordance with Sec.  112.45. For example, if you 
determine that water you use for a purpose listed in Sec.  112.44(a) 
does not meet the microbial quality criterion established in that 
section, Sec.  112.45(a) provides that you must take certain steps as a 
result. This Sec.  112.50(b)(6) requires that you establish and keep 
documentation of the steps taken to satisfy Sec.  112.45(a). In 
addition, in this section we are also establishing specific 
requirements for documentation of time intervals or calculated log 
reductions applied in accordance with Sec.  112.45(b)(1).
    We are also adding new Sec.  112.50(b)(9) to require that you 
retain documentation of any analytical methods you use in lieu of the 
method that is incorporated by reference in Sec.  112.151(a). Under 
Sec.  112.151(b)(1), you may use any scientifically valid method that 
is at least equivalent to the method of analysis in Sec.  112.151(a) in 
accuracy, precision, and sensitivity to satisfy the water testing 
requirements under Sec.  112.46. In addition, under Sec.  
112.151(b)(2), if you use an alternative indicator of fecal 
contamination in accordance with Sec.  112.49(a), you must use a 
scientifically valid method to test for the indicator. We conclude such 
records are necessary for us to verify and for you to ensure that 
appropriate methods are used for testing agricultural water. This 
provision is consistent with proposed Sec.  112.150(b)(5), which we 
have retained in this rule and which requires similar records regarding 
alternative analytical methods used when conducting testing required 
under subpart M for sprouts. We are also combining two proposed records 
requirements related to water testing results (proposed Sec.  
112.50(b)(2) and (5)) into one requirement in final Sec.  112.50(b)(2).
    (Comment 255) A comment requests clarification on the type of 
record that will sufficiently verify that the inspection of each water 
source and identification of potential hazards has been conducted as 
required in proposed Sec.  112.42.
    (Response) Under Sec.  112.50(b)(1), you are required to establish 
and keep records of your agricultural water system inspection findings 
under Sec.  112.42(a). Other than as provided generally for records 
required under this rule in subpart O, we are not further specifying 
the manner or format in which you prepare the record(s) to satisfy this 
recordkeeping requirement. We note that under Sec.  112.161(a)(1), all 
records required under this part must include, as applicable, the name 
and location of your farm, actual values and observations obtained 
during monitoring, an adequate description of covered produce 
applicable to the record, the location of a growing area or other area 
applicable to the record, and the date and time of the activity 
documented. Under Sec.  112.161(a)(2), records must be created at the 
time an activity is performed or observed, under Sec.  112.161(a)(3) 
they must be accurate, legible, and indelible, and under Sec.  
112.161(a)(4) they must be dated, and signed or initialed by the person 
who performed the activity documented. Covered farms may prepare and 
maintain documentation of their inspections and associated findings in 
a manner that is appropriate for the farm's operation provided that the 
records contain all necessary information and satisfy subpart O. Under 
Sec.  112.163(a), you are not required to duplicate any existing 
records if those records contain all of the required information and 
satisfy the requirements of this rule. Similarly, if you have records 
containing some but not all of the required information, Sec.  112.163 
provides you the flexibility to keep any additional information 
required either separately or combined with your existing records, even 
where the formats for each record may not be the same.

K. Compliance Periods Related to Agricultural Water

    For covered activities involving covered produce (except sprouts 
subject to subpart M), the compliance dates for water quality 
requirements in Sec.  112.44 and certain related provisions are two 
years beyond the compliance date for the rest of the final rule 
applicable to the covered farm based on its size. See Table 12.

[[Page 74461]]

  Table 12--Compliance Dates for Requirements in Subpart E for Covered
 Activities Involving Covered Produce (Except Sprouts Subject to Subpart
                                   M)
                           [See also Table 30]
------------------------------------------------------------------------
                                           Extended compliance date of
     Compliance dates of 2-4 years        additional 2 years beyond the
  applicable to the farm based on its     compliance date based on size
                  size                               of farm
------------------------------------------------------------------------
Sec.   112.41..........................  Sec.   112.44.
Sec.   112.42..........................  Sec.   112.45(a) with respect
                                          to Sec.   112.44(a) criterion.
Sec.   112.43..........................  Sec.   112.45(b).
Sec.   112.45(a) with respect to safe    Sec.   112.46(b)(2) and
 and adequate standard.                   (b)(3)Sec.   112.46(c).
Sec.   112.46(a).......................  Sec.   112.46(b)(1) with
                                          respect to untreated ground
                                          water.
Sec.   112.46(b)(1) with respect to
 untreated surface water.
Sec.   112.47..........................
Sec.   112.48..........................
Sec.   112.49..........................
Sec.   112.50..........................
------------------------------------------------------------------------

    Note that although most of Sec.  112.46 is subject to the extended 
compliance periods, Sec.  112.46(a) is not, and Sec.  112.46(b)(1) with 
respect to untreated surface water is not. Therefore, covered farms 
must initiate actions in compliance with Sec.  112.46(a) and, with 
respect to untreated surface water, Sec.  112.46(b)(1) under the 
regular compliance periods applicable to the remaining sections of this 
rule. Similarly, Sec.  112.47 is subject to the shorter compliance 
period because it establishes requirements that are relevant to testing 
requirements when they become applicable. See our response to Comment 
243 for an explanation for treating Sec.  112.46(b)(1) with respect to 
untreated surface water differently from the remaining water testing 
requirements for purposes of compliance. We recognize that farms may 
need additional time to prepare for implementation of the water quality 
testing, monitoring, and related record-keeping provisions. This 
additional 2-year compliance period for water quality requirements is 
also expected to permit farms to consider alternatives to the microbial 
quality criteria in Sec.  112.44(b), the microbial die-off rate in 
Sec.  112.45(b)(1)(i), or the testing frequencies in Sec.  
112.46(b)(1)(i)(A) and Sec.  112.46(b)(2)(i)(A), and develop adequate 
scientific data or information necessary to support a conclusion that 
the alternative would provide the same level of public health 
protection as the relevant requirement, 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. Therefore, for covered activities involving covered 
produce (except sprouts subject to subpart M), the extended compliance 
dates for certain water quality testing, monitoring, and related 
recordkeeping requirements identified in column 2 of Table 12 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.
    We are not similarly providing extended compliance periods for 
these specific water requirements, in the case of covered activities 
involving sprouts, as discussed in section XVIII.J of this document. 
Therefore, covered farms must comply with all of the applicable 
requirements of part 112, including subpart E, for all covered 
activities involving sprouts subject to subpart M, within one to three 
years of the effective date of the rule, depending on size of the farm. 
See also section XXIV.A of this document for additional information.

XIV. Subpart F--Comments on Biological Soil Amendments of Animal Origin 
and Human Waste

    In subpart F of proposed part 112, we proposed minimum standards 
directed to treated and untreated biological soil amendments of animal 
origin and human waste 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 reasonable 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. 
In the 2013 proposed rule and the supplemental notice, we asked for 
comment on our proposed provisions, including our decision not to 
establish requirements for chemical or physical soil amendments, or 
biological soil amendments that are not of animal origin; the 
appropriateness of treatment options considered for treated soil 
amendments; the appropriateness of the microbial standards selected and 
potential alternatives; and the proposed waiting periods between 
application and harvest (``application intervals''). In the 
supplemental notice, we withdrew our proposal for an application 
interval for untreated biological soil amendments of animal origin 
(including raw manure) and deferred our decision on an appropriate 
minimum application interval until such time as necessary for us to 
pursue certain steps, including a risk assessment and research to 
supplement the science on an appropriate interval.
    In this section of this document, we discuss comments we received 
on the standards directed to biological soil amendments of animal 
origin and human waste in the 2013 proposed rule, but that we did not 
address in the supplemental notice. We also discuss comments that we 
received on the new and amended proposed provisions in the supplemental 
notice.
    We are finalizing these provisions with revisions (see Table 13). 
We discuss these changes in this section. There are also revisions 
relevant to subpart F in the Definitions section in Sec.  112.3, which 
are described in section IX of this document.

[[Page 74462]]

             Table 13--Description of Revisions to Subpart F
------------------------------------------------------------------------
       Final provision                  Description of revisions
------------------------------------------------------------------------
Sec.   112.51................  --Revision to (a) and (b)(1) clarify that
                                agricultural teas covered are those for
                                which the biological materials include
                                materials of animal origin, and to
                                replace reference to Sec.   112.44(a)
                                with clarifying text.
                               --Revision to (b)(5) to clarify that
                                agricultural teas covered are those for
                                which the biological materials include
                                materials of animal origin.
                               --See Table 14 for additional
                                information.
Sec.   112.52................  --Revision to (a) to add other soil
                                amendments and to clarify that drip
                                fertigation with agricultural teas that
                                are biological soil amendments of animal
                                origin is permitted in compliance with
                                other requirements of this rule.
                               --Revision to (c) to replace ``that has
                                become'' with ``that you know or
                                reasonably believe may have become.''
                               --See Table 15 for additional
                                information.
Sec.   112.53................  --No change
Sec.   112.54................  --Revision to (a) and (b) to add
                                biological processes and replace
                                ``demonstrated'' with ``validated.''
                               --Rearrangement to combine relevant
                                provisions of proposed (c) into revised
                                (b).
                               --Renumbering of proposed (c)(1) to
                                (b)(1) and proposed (c)(2) to (b)(2) as
                                a conforming change to combining (b) and
                                (c).
                               --Elimination of proposed (c)(3) as not
                                necessary.
                               --Revision to descriptions of static
                                composting (in (b)(1)) and turned
                                composting (in (b)(2)) to further
                                clarify the processes.
                               --See Table 17 for additional
                                information.
Sec.   112.55................  --Revision to (a)(1) to add liquid
                                sampling.
                               --Revision to (a)(2) and (a)(3) to add
                                liquid sampling and indicate that it is
                                a `non-detect' standard.
                               --Revision to (b) to add liquid sampling
                                and indicate that the Salmonella method
                                is a `non-detect' standard.
                               --See Table 18 for additional
                                information.
Sec.   112.56................  --Revision to (a) to delete ``except as
                                provided in paragraph (b) of this
                                section.''
                               --Revision to combine proposed (a)(3) and
                                proposed (a)(4) as renumbered (a)(2),
                                corresponding to revised Sec.
                                112.54(b).
                               --Renumbering of proposed (a)(2) as
                                (a)(3).
                               --See Table 19 for additional
                                information.
Sec.   112.60................  --Revision to (b)(1) to eliminate
                                proposed (b)(1)(ii) and as a conforming
                                change to renumber (b)(1)(iii) to
                                (b)(1)(ii) and to require such
                                documentation at least annually.
                               --Elimination of (b)(3) as a conforming
                                change since proposed Sec.
                                112.54(c)(3) has been deleted.
                               --See Table 20 for additional
                                information.
------------------------------------------------------------------------

A. General Comments

    (Comment 256) Many comments state that biological soil amendments 
of animal origin can contain pathogenic bacteria that can cause 
foodborne illness in humans and therefore special precautions must be 
taken in their use. Some comments further cite certain provisions 
within subpart F that address the need for such special precautions and 
state that they were in alignment with current GAPs, some marketing 
orders, certain industry standards (in particular the mushroom industry 
standards), and that they are currently being followed by segments of 
the industry. These commenters generally agree with FDA's approach.
    Conversely, many comments take exception to our coverage of 
biological soil amendments and our approach to doing so, particularly 
the original proposal to require a 9-month application interval for 
untreated biological soil amendments of animal origin, including raw 
manure. Some comments state that mandatory requirements for biological 
soil amendments of animal origin are not needed, or should be in 
guidance rather than a regulation.
    (Response) FDA continues to conclude that biological soil 
amendments of animal origin are an important route of contamination on 
farm and, therefore, we do not believe it would be sufficient merely to 
make recommendations related to biological soil amendments of animal 
origin in guidance. We have finalized our QAR and it supports this 
conclusion. With regard to comments on the application interval for 
untreated biological soil amendments of animal origin, including raw 
manure, which was proposed in the 2013 proposed rule and withdrawn in 
the supplemental notice, see Comment 257.
    (Comment 257) Many commenters suggest that provisions within 
subpart F should be written to align with NOP standards. Some comments 
expressed concern that the provisions of subpart F would cause farms to 
use specific methods of agriculture, including use of synthetic 
fertilizers, which would eliminate a farm's ability to become certified 
organic. Some comments state that organic farming provides a benefit in 
protecting the public health from consequences associated with the use 
of harmful chemical pesticides, herbicides, and synthetic fertilizers, 
and already includes a food safety component and has an excellent track 
record on food safety. Other comments suggest FDA adopt NOP standards 
because farms are already accustomed to implementing them. Further, 
other comments recommended that FDA and USDA collaborate to align their 
respective regulations to be maximally protective of the public health 
from both foodborne illness and environmental health perspectives.
    (Response) We do not agree that the provisions of subpart F are in 
conflict with NOP standards or would require farms to use synthetic 
amendments such that they could not achieve organic certification. The 
provisions of subpart F allow use of both treated and untreated 
biological soil amendments of animal origin, as long as they are 
applied in accordance with Sec.  112.56. The provisions of Sec.  112.54 
allow for biological (including composting), chemical, and physical 
treatment processes, or combinations thereof, for producing treated 
biological soil amendments of animal origin, as long as they meet the 
microbial standards in Sec.  112.55. We do not believe it would be 
appropriate to broadly adopt USDA's NOP standards for biological soil 
amendments of animal origin because they were established for purposes 
of organic certification and not for produce safety. However, we do 
agree that inter-agency collaboration to align goals and approaches, in 
order to minimize individual requirements placed on the

[[Page 74463]]

industry, is beneficial. FDA has worked, and will continue to work, 
with USDA to ensure our programs do not have conflicting or duplicative 
measures.
    With regard to the application interval for use of untreated 
biological soil amendments of animal origin, including raw manure, in 
response to our original proposal we received many comments taking 
issue with our proposed 9-month interval. In response to these 
comments, we indicated in the supplemental notice (79 FR 58434 at 
58460-58461) that we were deferring action on an application interval 
until we pursued certain steps including a risk assessment and research 
to supplement the science on an appropriate interval. We anticipate 
that these efforts will take 5 to 10 years to complete. Following the 
completion of the risk assessment and research work, we expect to: (1) 
Provide stakeholders with data and information gathered from scientific 
investigations and risk assessment; (2) consider such new data and 
information to develop tentative scientific conclusions; (3) provide an 
opportunity for public comment on our tentative decisions; and (4) 
consider public input to finalize the provision(s) establishing an 
appropriate minimum application interval(s).
    (Comment 258) Several comments agree with our decision in the 
supplemental notice to pursue a risk assessment and research prior to 
establishing an application interval for untreated biological soil 
amendments of animal origin, including raw manure. However, other 
comments state that 5-10 years would be too long to wait for the public 
health benefits of setting such an application interval, that there is 
science demonstrating that a 120-day interval would be an appropriately 
protective interim standard while FDA pursues its risk assessment and 
research, that many in the agricultural community are already applying 
a 120-day interval, and that FDA should establish a 120-day application 
interval for raw manure as an ``interim'' standard for the intervening 
5-10 years while FDA pursues its risk assessment and research agenda 
and additional rulemaking. Conversely, some comments state it is not 
appropriate for FDA to establish an application interval based on the 
NOP interval (90/120 days depending on the crop), because the NOP 
standards require incorporating manure into the soil after application 
and were established for the purpose of maintaining organic integrity, 
and not for produce safety.
    Some other comments relating to application intervals include a 
suggestion that we subject only liquid manures to a 9-month application 
interval based on an asserted greater risk presented by liquid manure 
as compared to non-liquid manure, a suggestion that we count the time 
period when soil is frozen toward any application interval, and a 
request that we conduct research to determine the impact of hard 
freezes on survivorship of pathogens in northern climates.
    (Response) As explained in the supplemental notice (79 FR 58434 at 
58460-58461), FDA withdrew its proposal for an application interval for 
untreated biological soil amendments of animal origin, including raw 
manure, and indicated that it would establish such an interval after 
pursuing a risk assessment and research agenda to supplement the 
science regarding an appropriate interval. Because FDA withdrew its 
proposal for such an application interval, we do not have a proposal to 
finalize at this time. To establish an application interval for 
untreated biological soil amendments of animal origin, FDA will need to 
undertake notice-and-comment rulemaking consistent with the 
Administrative Procedure Act (5 U.S.C. 553). We recognize that we could 
provide public health protection by applying an application interval 
for untreated biological soil amendments of animal origin while we 
pursue our risk assessment and research, and the familiarity of the 
farm community with the NOP 90/120-day interval. We also recognize that 
FDA stated in the supplemental notice that it would pursue its risk 
assessment and research agenda before proposing to establish such an 
application interval, and that some comments oppose establishing an 
interval by regulation before completion of that agenda. FDA is 
considering appropriate next steps. However, we will not establish an 
application interval for untreated biological soil amendments of animal 
origin without giving the public a chance to provide comment on a 
proposed interval.
    As noted in the supplemental notice, we continue to believe that a 
quantitative application interval standard, established in part 112, is 
necessary to minimize the likelihood of contamination of produce 
resulting from the use of untreated biological soil amendments of 
animal origin, including raw manure, in a manner that contacts covered 
produce. We acknowledged in the supplemental notice that many farms 
currently employ the NOP standard of 90 days or 120 days, as specified 
in 7 CFR 205.203(c)(1), and we recognize that such farms will likely 
continue their current practice to use this standard in organic crop 
production, in the absence of an FDA regulation that establishes a food 
safety standard for minimum application intervals associated with the 
use of untreated biological soil amendments of animal origin such as 
raw manure. Given that the scientific literature demonstrates that the 
probability of pathogen survival decreases as the length of time 
between application of untreated biological soil amendments of animal 
origin and harvest increases, and that more rapid die-off occurs during 
the months immediately following application (e.g., three to four 
months) as compared to subsequent months (followed by prolonged 
survival of pathogens at low levels), we believe adherence to the NOP 
standard to be a prudent step toward minimizing the likelihood of 
contamination while the above described risk assessment and research 
program is ongoing. At this time, we do not intend to take exception to 
the continuation of this practice in the interim period.
    (Comment 259) One comment recommends only stabilized compost that 
has not been subjected to cross-contamination and re-growth of 
pathogens be allowed for use on agricultural lands designated for 
production of ready-to-eat foods.
    (Response) FDA agrees that stabilized compost (or any treated 
biological soil amendment of animal origin) must be handled, conveyed, 
and stored 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 (Sec.  112.52(b)) and that it should be 
considered untreated if it has become contaminated (Sec.  112.52(c)). 
However, we do not agree that only stabilized compost should be allowed 
to be used during the growing of covered produce (or more broadly as 
suggested by the comment). As described in Comment 277 there are 
several different types of biological soil amendments of animal origin 
that are appropriate for use on land used to grow covered produce, and 
this rule does not restrict use of other types of soil amendments not 
subject to subpart F (such as chemical and physical soil amendments and 
biological soil amendments that are not of animal origin). All such 
soil amendments may be used in the growing of covered produce, provided 
that all biological soil amendments of animal origin and human waste 
are used in accordance with the requirements in subpart F.
    (Comment 260) A commenter requests only mammalian and avian species 
be included in the definition of ``biological soil amendments of animal 
origin'' and

[[Page 74464]]

therefore subject to the requirements of subpart F.
    (Response) Animals other than mammalian and avian species, such as 
fish, amphibians, and reptiles, are known to carry human pathogens 
(e.g., Salmonella) (Ref. 165) (Ref. 166) (Ref. 167) and fecal 
contamination by such animals is a concern. The comment did not provide 
information to support the request that only certain species be 
covered. FDA concludes that the risks posed by biological soil 
amendments from all animal sources should be addressed through 
inclusion in the term ``biological soil amendments of animal origin'' 
and resulting requirements under subpart F of this rule.
    (Comment 261) Some comments state that food safety on a farm is 
related to the microbial soil ecology, and that biological diversity 
adds to soil health and protects the environment, while ``sterile'' 
soils lack this healthy fertility. Some comments also suggest healthy 
soils are essential to food safety, can boost the nutrient content of 
food, and contribute to long-term food security by ensuring land is 
viable for diverse, long-term production systems. Comments request that 
we explore ways to enhance the safety of covered produce while 
promoting biological diversity in soil ecology.
    (Response) FDA agrees that soil health, environmental stewardship, 
and reducing the risk of food becoming contaminated with pathogens are 
all important and are not mutually exclusive. We intend to work with 
stakeholders to address co-management of produce safety and the 
environment.
    (Comment 262) Comments focusing on environmental concerns 
associated with chemical fertilizer use requested that FDA revise the 
proposed produce safety rule to remove any incentives it may create for 
using chemical fertilizers as a replacement for biological soil 
amendments of animal origin.
    (Response) As discussed in the 2013 proposed rule (78 FR 3504 at 
3576), animal waste is likely to contain human pathogens. 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, and we 
are still not aware of any situation in which chemical or physical soil 
amendments, such as elemental fertilizers, soil stabilizers, or others 
typically made of mined or synthetic materials, have served as sources 
of microbial contamination. Therefore, neither chemical nor physical 
soil amendments are a focus of this rule. Instead, we focus on 
biological soil amendments of animal origin and human waste, which 
present a reasonable likelihood of harboring human enteric pathogens. 
We do not believe our focus on biological soil amendments of animal 
origin incentivizes the use of chemical fertilizers. However, we did 
consider the effect of farms switching to chemical fertilizers in the 
EIS and concluded that a switch away from biological soil amendments of 
animal origin to chemical fertilizers could cause moderate adverse 
environmental impacts to soils, but not to a significant level because 
such effects are reversible and may be mitigated through other 
practices that are growing in popularity such as green manuring, no-
till practices, and use of cover crops. FDA expects that the cumulative 
effects nationwide related to soil health and biological soil 
amendments of animal origin will not be significant. See discussion in 
Chapter 5.5 of the EIS (Ref. 126).
    (Comment 263) One comment suggested that biological soil amendments 
that do not contain animal waste, such as yard trimmings from a 
municipal source, residential, or public properties, have the potential 
to be contaminated with domestic and wild animal feces and pose a risk 
to public health. The commenter therefore suggests FDA include 
requirements for complete composting before allowing use of any ``green 
waste'' (meaning biological soil amendments not of animal origin). 
Another comment noted a study (Ref. 168) that concluded the presence or 
absence of manure is not a suitable predictor of the pathogen load of a 
stabilized compost, suggesting that ``green waste'' should not be 
treated as less risky than biological soil amendments of animal origin. 
Conversely, other comments agreed with FDA's tentative conclusion that 
biological soil amendments that do not contain animal or human waste 
products are low-risk products, suggesting that the tentative 
conclusion to exclude biological soil amendments not of animal origin 
from the requirements of the rule is sensible. These commenters 
believed that restrictions on the use of biological soil amendments 
that are not of animal origin, as defined in this subpart, would be 
unnecessary due to an extremely low likelihood of contamination from 
these soil amendments.
    (Response) FDA appreciates the comments indicating that there is 
some risk associated with biological soil amendments not of animal 
origin (or ``green waste''). First, we note that the definitions of 
``yard trimmings'' and ``pre-consumer vegetative waste'' in Sec.  
112.3(c) stipulates that these are purely vegetative materials. To the 
extent that vegetative waste is known to include animal feces, it would 
not meet the definitions of ``yard trimmings'' or ``pre-consumer 
vegetative waste,'' and a soil amendment made from such material would 
instead be a biological soil amendment of animal origin included in the 
scope of the provisions of subpart F. However, we recognize that even 
in purely vegetative material such as that described in the definition 
of ``yard trimmings'' or ``pre-consumer vegetative waste,'' there is 
the potential for unknown and unavoidable contamination with animal 
waste. We have concluded that the likelihood of contaminating produce 
with pathogens by use of biological soil amendments that are not known 
to contain, and not likely to contain significant animal waste or human 
waste (e.g., yard trimmings, pre-consumer vegetative waste) is low, and 
therefore they are not subject to the requirements of this rule.
    With regard to the comment that highlighted a paper on the presence 
of pathogens of public health concern in purely vegetative material, we 
agree that no biological soil amendment is without risk. However, we 
conclude that the relative risks are greatest with untreated biological 
soil amendments of animal origin due to the highly likely presence of 
human pathogens in such materials, and that is where we are choosing to 
focus our regulatory efforts. We note that there is currently not a 
great deal of research on pathogen presence in biological soil 
amendments not containing animal material. We will continue to follow 
the science pertaining to this issue and will consider appropriate next 
steps should there be additional evidence that this is an area of 
public health concern.
    Finally, we note that Sec.  112.52(a) requires that a biological 
soil amendment of animal origin be handled, conveyed, and stored 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. We 
are revising this provision to include a requirement that biological 
soil amendments be handled, conveyed and stored such that they do not 
contaminate other soil amendments. In addition, if you know that a soil 
amendment that had originally not contained animal material has been in 
contact with, or otherwise contaminated by, a biological soil amendment 
of animal origin, you should consider the

[[Page 74465]]

possibility that, depending on the circumstances, the soil amendment 
may meet the definition of a biological soil amendment of animal origin 
and therefore be subject to the requirements of subpart F.
    (Comment 264) Some comments suggest that the provisions in subpart 
F would disallow farmers from utilizing manure produced on their own 
farms as part of a ``closed-loop'' or ``zero-input'' sustainability 
program, or that farms would be disallowed from having compost curing 
and storage on site.
    (Response) The provisions of subpart F do not prohibit farms from 
using manure produced on the farm, including manure produced as part of 
a sustainability program, nor does it prohibit farms from curing or 
storing compost on site. Covered farms must conduct relevant activities 
in accordance with the provisions of subpart F.
    (Comment 265) One comment requests clarification on whether ``table 
waste'' would be an example of a biological soil amendment of animal 
origin. In addition, other comments request clarification on what is 
included in the category ``table waste,'' and express concern that this 
may also include food preparation waste such as raw meat. Some comments 
state stabilized compost derived from ``table waste'' or ``post-
consumer food waste,'' and stabilized compost derived from manure 
represent different types and levels of risk and should be examined 
separately.
    (Response) FDA proposed to define, and is now finalizing its 
definition of ``table waste'' as ``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'' (Sec.  112.3(c)). Table waste is explicitly included within 
the definition of ``biological soil amendment of animal origin'' in 
Sec.  112.3(c), making it subject to the requirements in subpart F of 
this rule. As discussed in the 2013 proposed rule (78 FR 3504 at 3548-
9), the definition of ``table waste'' is intended to distinguish post-
consumer food waste from pre-consumer vegetative waste. Also as 
discussed in the 2013 proposed rule (78 FR 3504 at 3574), post-consumer 
food waste, or table waste (such as plate scrapings), has a greater 
likelihood of being contaminated, or being contaminated at higher 
populations, with human pathogens of public health significance 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.). On the other hand, food preparation waste that 
is solely of plant origin may be considered ``pre-consumer vegetative 
waste'' (and therefore not subject to the requirements in subpart F) if 
it meets the terms of that definition (Sec.  112.3(c)). Notably, we are 
defining ``pre-consumer vegetative waste'' in part to require that 
these materials may not have come in contact with animal products, 
byproducts or manure or with an end-user (consumer). We are also 
excluding table waste, packaging that has come in contact with 
materials (such as meat) that are not vegetative in origin, and any 
waste generated by restaurants. Any material of animal origin (such as 
meat) that is added to a soil amendment, regardless of whether it has 
been served to or come in contact with a consumer, renders that soil 
amendment a biological soil amendment of animal origin subject to the 
requirements of subpart F. We acknowledge that a variety of feedstocks 
may be used to produce treated biological soil amendments of animal 
origin, including stabilized compost, and that feedstocks differ with 
respect to their inherent risk. Therefore, in subpart F we chose to 
establish requirements for the end product of treatment (i.e., the 
stabilized compost) rather than the feedstock. If a feedstock is 
treated to meet the standards of Sec. Sec.  112.54 and 112.55, we 
conclude that the end product may be used in accordance with 
requirements for treated biological soil amendments of animal origin 
rather than untreated biological soil amendments of animal origin in 
Sec.  112.56. We note that, depending on the level of treatment 
received, the end products present differing levels of risk reflected 
in the different application requirements established in Sec.  112.56.
    (Comment 266) One comment requests FDA not subject manure from 
grass-fed animals to the requirements of subpart F. The comment states 
manure from grass-fed animals does not contain harmful levels of E. 
coli and other noxious bacteria.
    (Response) FDA is not providing an exemption from subpart F for 
manure from grass-fed animals used as a soil amendment. We are not 
aware of evidence to support the assertion made by the commenter and 
the comment did not provide any such data or other information.
    (Comment 267) Some comments recommend FDA specifically exempt tree 
nuts from the biological soil amendment requirements in the rule. These 
comments state that certain types of tree nuts never touch the ground 
and most tree nut farms use non-biological soil amendments.
    (Response) If a covered farm does not use biological soil 
amendments of animal origin, then the provisions of subpart F are not 
applicable to that covered farm. In addition, the requirements we are 
establishing in Sec.  112.56 allow use of both treated and untreated 
biological soil amendments of animal origin in situations where there 
is no contact between the covered produce and the soil amendment. Thus, 
we do not believe it is necessary or appropriate to exempt tree nuts 
from this subpart, as suggested by the comment.
    (Comment 268) Some comments stated that raw manure is preferable to 
stabilized compost because raw manure has greater nitrogen content. 
These comments indicated that farms that switch from raw manure to 
stabilized compost will need to use additional stabilized compost to 
make up the loss in nitrogen content. These comments expressed concern 
that such changes would interfere with nutrient management programs and 
increase nutrient runoff into waterways.
    (Response) As we noted in the supplemental notice, we recognize 
that some loss of nitrogen during the composting process is likely 
(Ref. 169) and that adjustments to fertility management will be 
necessary when shifting to use of stabilized compost. However, we 
continue to believe that use of stabilized compost is preferable to use 
of raw manure for growing covered produce because of the higher 
likelihood of pathogens associated with raw manure. With regard to 
concerns about nutrient management programs and runoff, we note that 
stabilized compost has stabilized forms of nitrogen, which are less 
susceptible to leaching or runoff than unstabilized forms (Ref. 170) 
(Ref. 171). At the same time, stabilized compost also retains many 
other key values of raw manure, including serving as a supply of carbon 
to support diverse and abundant soil microbial communities, which serve 
important functions in nutrient cycling, conditioning of soil physical 
and chemical properties, and in some cases crop protection from 
phytopathogenic diseases (Ref. 171) (Ref. 172) (Ref. 173). Concerns 
about runoff from biological soil amendments of animal origin are also 
addressed in the final EIS (Ref. 126).
    (Comment 269) One comment points out that the ability to safely and 
responsibly handle waste from animal livestock production and 
processing, primarily swine and poultry operations, is critical to the 
agricultural economy.

[[Page 74466]]

The comment further states swine and poultry waste is applied primarily 
to crops such as corn or soybeans, or in forestry plantations.
    (Response) Nothing in this rule prevents the use of waste from 
animal livestock production and processing as biological soil 
amendments of animal origin, provided that the amendments are produced 
and used in accordance with the relevant provisions of subpart F. We 
also note that dent- or flint-corn and soybeans are excluded from the 
definition of ``produce'' in this rule because they are grains (Sec.  
112.3(c)) and are therefore not subject to this rule. Sweet corn is 
exempt from the rule because it is on the list of produce that FDA has 
determined is ``rarely consumed raw'' in Sec.  112.2(a)(1). Further, 
lumber is also not ``produce'' for purposes of this rule and forestry 
plantations producing lumber are therefore not subject to this rule.
1. Use of Agricultural Teas
    (Comment 270) Many comments recommend agricultural teas should be 
regulated using the same standards as stabilized compost. Specifically, 
some comments suggest that agricultural tea used as a soil amendment in 
direct soil application with covered produce poses a significant risk, 
and that such teas are often produced on-farm, with little emphasis on 
minimizing the presence of pathogens. Several other comments discuss 
agricultural tea as having unique food safety risks and request that 
FDA address agricultural teas separately within Sec.  112.56. These 
comments ask FDA to establish reasonable, scientifically based minimum 
application intervals for use of agricultural teas as soil amendments 
and to require that they be applied in a manner that has minimal 
potential for contact with covered produce during and after 
application. On the other hand, some comments argue that agricultural 
teas prepared from stabilized compost in accordance with NOP standards 
do not carry any food safety risks and therefore should have no 
application interval requirements. One such comment provides two 
literature citations to argue that pathogens such as E. coli and 
Salmonella, are poor at surviving on plants and are quickly overrun by 
normal, plant colonizing bacteria. The comment argues that more 
significant risks are posed by anaerobically prepared manure or non-NOP 
compliant agricultural teas, which the comment argues should be banned 
from use as soil amendments.
    (Response) FDA agrees that agricultural teas that are biological 
soil amendments of animal origin (see Comment 271) should be regulated 
similarly to other biological soil amendments of animal origin, with 
appropriate attention given to their unique qualities, and we believe 
we have done so in this rule. Under Sec.  112.51, the components of an 
agricultural tea (of animal origin) must be processed to the same 
standards as other biological soil amendments of animal origin to be 
classified as a treated biological soil amendment of animal origin, 
with the addition of specific requirements for the quality of the water 
used to produce the tea (see Sec. Sec.  112.51(a) and (b)(1)) and the 
heightened risk presented by the use of agricultural tea additives (see 
Sec.  112.51(b)(5)). We consider that, in connection with the 
provisions of Sec.  112.51 just described, the treatment processes 
described in Sec.  112.54 and the microbial standards of Sec.  112.55 
are adequate for all biological soil amendments of animal origin, 
including agricultural teas (of animal origin), and it is not necessary 
to also include a separate section in Sec.  112.56 regarding 
agricultural teas (of animal origin). We have addressed the unique 
risks of agricultural teas (of animal origin) by limiting in Sec.  
112.51 the circumstances under which they may be considered 
``treated.'' Thus, agricultural teas (of animal origin) made with 
untreated surface water, or water that has detectable generic E. coli 
in 100 mL of water; and agricultural teas (of animal origin) that 
contain agricultural tea additives are considered ``untreated'' and 
must be applied in accordance with Sec.  112.56(1)(i) or (ii). In 
addition, like all other biological soil amendments of animal origin, 
agricultural teas (of animal origin) must be considered untreated and 
applied in accordance with Sec.  112.56(1)(i) or (ii) if they fall 
within any of the categories in Sec.  112.51(b) (for example, if the 
biological materials of animal origin used to make the tea are not 
processed to completion in accordance with the requirements of Sec.  
112.54, or if they have been contaminated after treatment).
    The comment asserting the safety of agricultural teas produced from 
stabilized compost following NOP standards did not provide data or 
information supporting that assertion. However, we note that under 
Sec. Sec.  112.56(a)(2) or (a)(3), biological soil amendments of animal 
origin that are agricultural teas prepared from properly handled 
stabilized compost (i.e., biological materials of animal origin are 
processed to completion in accordance with Sec.  112.54 to meet 
relevant microbial standards in Sec.  112.55; made with water 
satisfying the requirements of Sec.  112.51(a); and not otherwise 
considered ``untreated'' under Sec.  112.51(b)) have an application 
interval of zero days, and application method restrictions that vary 
based only on the level of treatment provided by the processing. Under 
Sec.  112.56(a)(1), other biological soil amendments of animal origin 
that are agricultural teas and that are considered ``untreated'' under 
Sec.  112.51(b) must be applied in a manner that does not contact 
covered produce at application and minimizes potential for contact 
after application, or in a manner that does not contact covered produce 
during or after application. See Comment 257 regarding our plans 
relating to a minimum application interval for untreated biological 
soil amendments of animal origin applied in a manner that contacts 
covered produce.
    With regard to the comment about anaerobic preparation, FDA does 
not consider that there is enough evidence in the literature to link 
the method of agricultural tea production (actively aerated or 
anaerobic brewing) to a difference in E. coli risk. Most enteric 
bacterial pathogens (such as E. coli and Salmonella spp.) are 
classified as facultative anaerobic organisms; these organisms will 
grow faster and out-compete other organisms at a faster rate in an 
aerobic environment, as compared to an anaerobic environment, provided 
the same amount of nutrients and conditions for growth are present in 
both environments. It is a common misperception that these pathogens 
thrive better in an anaerobic environment than in an aerobic one (Ref. 
174). The scientific literature points to agricultural tea additives, 
and not brewing method, as the main factor associated with human 
pathogen growth in agricultural teas (Ref. 174).
    (Comment 271) Several comments state that agricultural teas are not 
typically considered to be agricultural water; are applied 
sporadically, sometimes very close to harvest; and are used in 
conjunction with plants, other microbes, nutrients, and the soil to 
suppress disease, improve soil structure, maintain nutrients, and 
increase water holding capacity. These comments recommend that FDA 
clarify that the water used to make agricultural tea, or the resulting 
agricultural tea, does not need to meet the requirements for 
``agricultural water'' in subpart E.
    (Response) In Sec.  112.3(c) of this rule, we are revising the 
definition of ``agricultural tea'' to include an explicit statement 
that ``[a]gricultural teas are soil amendments for purposes of this 
rule.'' We recognize that agricultural

[[Page 74467]]

teas may be applied in some cases for purposes in addition to those 
specified in our definition of ``soil amendment,'' that is, ``to 
improve the chemical or physical condition of the soil in relation to 
plant growth or to improve the capacity of the soil to hold water.'' 
However, we understand that even when such additional purposes exist, 
agricultural teas are generally used for the purposes described in the 
definition of ``soil amendment'' in this rule. In addition, we believe 
that the appropriate requirements to apply to agricultural teas made 
with materials of animal origin are those we have established in 
subpart F of this rule for biological soil amendments of animal origin, 
and not the requirements in subpart E that apply to agricultural water. 
We are removing the reference to agricultural tea in subpart E of this 
rule, in proposed Sec.  112.44(a)(3), because it was confusing. Water 
used to make an agricultural tea must not be untreated surface water, 
and must meet the same microbial criteria as that set forth in Sec.  
112.44(a) for the resulting agricultural tea to be considered 
``treated'' under Sec.  112.51 in subpart F. Whether a biological soil 
amendment of animal origin is ``treated'' or ``untreated'' under Sec.  
112.51 affects the application restrictions that apply to its use in 
Sec.  112.56. However, we do not intend to require that agricultural 
teas, or the water used to make them, meet other requirements in 
subpart E for agricultural water. Thus, we are deleting the reference 
to agricultural teas in subpart E, making the revision discussed 
previously to the definition of ``agricultural tea,'' and revising to 
Sec.  112.51(a) and (b)(1) to clarify this. As revised, Sec.  112.51(a) 
provides that ``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 of animal origin used to make the tea have 
been so processed, the water used to make the tea is not untreated 
surface water, and the water used to make the tea has no detectable 
generic Escherichia coli (E. coli) in 100 milliliters (mL) of water.'' 
As revised, Sec.  112.51(b)(1) provides that ``a biological soil 
amendment of animal origin is untreated if 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 of animal 
origin used to make the tea have not been so processed, or the water 
used to make the tea is untreated surface water, or the water used to 
make the tea has detectable generic Escherichia coli (E. coli) in 100 
milliliters (mL) of water.''
    We also note that to the extent agricultural teas are being used as 
pesticides, FIFRA provides for federal regulation of their 
distribution, sale, and use. All pesticides distributed or sold in the 
United States must be registered (licensed) by EPA. The term 
``pesticide chemical'' is also defined in section 201(q) of the FD&C 
Act. Food bearing or containing a pesticide chemical residue is 
adulterated under 402(a)(2)(B) unless a tolerance is in effect and the 
quantity of the residue is within the limits of the tolerance, or an 
exemption from the requirement of a tolerance is in effect (see section 
408(a) of the FD&C Act). EPA has established tolerances, and exemptions 
from the requirement of a tolerance, in 40 CFR part 180, subparts C and 
D, respectively. For more information, see http://www2.epa.gov/pesticide-registration/pesticide-registration-manual-chapter-1-overview-requirements-pesticide#laws and http://www2.epa.gov/pesticide-registration/pesticide-registration-manual-chapter-11-tolerance-petitions (Ref. 127) (Ref. 174a)
    (Comment 272) One comment states that the 2013 proposed rule does 
not distinguish between ``compost extracts'' and ``compost teas.'' 
Compost extracts as described by the commenter are simply water 
infusions of compost, without any ``compost tea additive'' (what we 
have termed ``agricultural tea additive''). The comment states that 
compost extracts without ``compost tea additives'' should have no 
greater restrictions than the compost that was used to make the tea.
    (Response) As discussed in response to Comment 270, this rule 
regulates agricultural teas that are biological soil amendments of 
animal origin similarly to other biological soil amendments of animal 
origin, with appropriate attention given to their unique qualities, 
including whether they contain agricultural tea additives as we have 
defined that term in Sec.  112.3(c). Further, this rule does 
distinguish between agricultural teas, as we have defined that term in 
Sec.  112.3(c), and other extracts. FDA defines ``agricultural tea'' to 
mean ``a water extract of biological materials (such as stabilized 
compost, 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 teas are soil amendments for purposes 
of this rule.'' An agricultural tea (of animal origin) must be used in 
accordance with the provisions of Sec.  112.56 in accordance with its 
status as a `treated' or `untreated' biological soil amendment of 
animal origin. In response to Comment 270, we describe how those 
requirements differ for agricultural teas that are biological soil 
amendments of animal origin as compared to other biological soil 
amendments of animal origin. A water extract of biological materials of 
animal origin that is not an agricultural tea (such as extracts that 
are held (i.e., ``steeped'') for less than one hour before application) 
may still be a biological soil amendment of animal origin if it fits 
that definition, in which case it is subject to the requirements for 
biological soil amendments of animal origin in subpart F.
    (Comment 273) One comment argues that the rule places restrictions 
on agricultural teas made from biological materials not of animal 
origin that are not reasonable, given the proposed exclusion of other 
biological soil amendments of non-animal origin from the coverage of 
subpart F.
    (Response) We based our proposed definition of ``agricultural tea'' 
in part on a similar definition of ``compost tea'' used by the NOSB (78 
FR 3545). We did not limit this definition to teas made from biological 
materials of animal origin because we intended to describe the wide 
range of agricultural teas used in the production of produce in this 
definition. However, we agree that, consistent with the scope of this 
rulemaking, agricultural teas made entirely from vegetative material 
are excluded from the requirements of subpart F that apply to 
biological soil amendments of animal origin. This is achieved not 
through the scope of the definition of ``agricultural tea,'' but by the 
fact that the requirements in subpart F refer in all relevant locations 
to biological soil amendments of animal origin, thus requiring that 
there be some component of animal origin in the biological soil 
amendment feedstock (or, in the case of Sec.  112.53, human waste). To 
improve clarity, we are amending the three appearances of the term 
``agricultural tea'' in Sec.  112.51 to specify that the biological 
materials used to make the tea include materials of animal origin.

B. Determining the Status of a Biological Soil Amendment of Animal 
Origin (Sec.  112.51)

    In proposed Sec.  112.51, we proposed to establish requirements for 
determining

[[Page 74468]]

the status of a biological soil amendment of animal origin as being 
treated or untreated, for use in covered activities. In Table 14, we 
describe the codified provisions of Sec.  112.51 and any changes we 
made to those provisions in the final rule. Comments specific to Sec.  
112.51 follow the table.

           Table 14--Description of Revisions to Sec.   112.51
------------------------------------------------------------------------
                                                     Final revisions, if
     Proposed provision         Proposed language            any
------------------------------------------------------------------------
Sec.   112.51(a)............  A biological soil     Revised to clarify
                               amendment of animal   that agricultural
                               origin is treated     teas covered are
                               if it has been        those for which the
                               processed to          biological
                               completion to         materials include
                               adequately reduce     materials of animal
                               microorganisms of     origin, and to
                               public health         replace reference
                               significance in       to Sec.   112.44(a)
                               accordance with the   with clarifying
                               requirements of       text.
                               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
                               Sec.   112.44(a).
Sec.   112.51(b)(1).........  A biological soil     Revised to clarify
                               amendment of animal   that agricultural
                               origin is untreated   teas covered are
                               if: (1) It has not    those for which the
                               been processed to     biological
                               completion in         materials include
                               accordance with the   materials of animal
                               requirements of       origin, and to
                               Sec.   112.54, or     replace reference
                               in the case of an     to Sec.   112.44(a)
                               agricultural tea,     with clarifying
                               the biological        text.
                               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
                               Sec.   112.44(a).
Sec.   112.51(b)(2).........  A biological soil     No change.
                               amendment of animal
                               origin is untreated
                               if: (2) It has
                               become contaminated
                               after treatment.
Sec.   112.51(b)(3).........  A biological soil     No change.
                               amendment of animal
                               origin is untreated
                               if: (3) It has been
                               recombined with an
                               untreated
                               biological soil
                               amendment of animal
                               origin.
Sec.   112.51(b)(4).........  A biological soil     No change.
                               amendment of animal
                               origin is untreated
                               if: (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.
Sec.   112.51(b)(5).........  A biological soil     Revised to clarify
                               amendment of animal   that agricultural
                               origin is untreated   teas covered are
                               if: (5) It is an      those for which the
                               agricultural tea      biological
                               that contains an      materials include
                               agricultural tea      materials of animal
                               additive.             origin.
------------------------------------------------------------------------

    (Comment 274) A comment recommends that FDA make a distinction 
between raw animal manures and other animal-based fertilizers such as 
bone, feather, and blood meal, which are commercially processed.
    (Response) FDA's approach does distinguish between ``treated'' and 
``untreated'' biological soil amendments of animal origin. The 
distinction is established in Sec.  112.51 and is made based upon the 
components, processing, handling, and other information about the soil 
amendment, and not the particular type of animal component that was the 
feedstock (starting material). Application restrictions for treated and 
untreated biological soil amendments of animal origin are described in 
Sec.  112.56.
    (Comment 275) One comment generally agrees with our regulatory 
descriptions in Sec.  112.51(b) of biological soil amendments of animal 
origin that are untreated, but asked us to modify Sec.  112.51(b)(4) so 
that if any discrete component of a soil amendment is untreated, the 
entirety is considered untreated. The comment argues that whether any 
untreated component part renders the entirety ``untreated'' should not 
depend on whether the farm knows or has reason to believe that the 
untreated component is contaminated.
    (Response) FDA agrees that if any discrete component of a soil 
amendment is untreated, the entirety is considered untreated. However, 
such situations are addressed in Sec.  112.51(b)(1) (not processed to 
completion), (b)(2) (contaminated after treatment), and (b)(3) 
(recombined with an untreated biological soil amendment of animal 
origin). The comment misunderstands Sec.  112.51(b)(4), which refers to 
a situation in which, for example, you find out that your feedstock (or 
a portion of it) was contaminated with a pathogen, or associated with 
foodborne illness. In such cases, FDA concludes that you should be 
required to consider the biological soil amendment to be untreated for 
purposes of subpart F, including the application restrictions in Sec.  
112.56. If there is reason to think that materials used in a biological 
soil amendment of animal origin are actually contaminated or associated 
with foodborne illness, there is a need to apply the most stringent 
controls to such materials, even if they have undergone a treatment 
process meeting the requirements of Sec. Sec.  112.54 and 112.55.
    (Comment 276) One comment disagrees with FDA's decision to treat 
agricultural teas (of animal origin) that contain additives as 
``untreated'' because FDA cited only one study by Ingram and Millner 
(Ref. 174). This comment cites a reference (Ref. 175) which, according 
to the commenter, showed that while the addition of molasses as an 
agricultural tea additive at 1 percent enhanced growth of Salmonella 
and E. coli O157:H7 in an agricultural tea, the addition of 0.2 percent 
molasses did not. Further, the comment argues that the addition of 
carrot juice as an agricultural tea additive was shown to inhibit the 
growth of nonpathogenic E. coli in swine manure compost extract (Ref. 
176). This comment contends that FDA should focus on factors other than 
the addition of additives to determine requirements for agricultural 
teas.
    (Response) FDA recognizes that many agricultural tea production 
practices include the addition of nutrient additives (such as molasses) 
during the steeping process, a practice designed to rapidly increase 
the indigenous heterotrophic microbiological populations extracted from 
the biological feedstock. The two studies mentioned in the comment do, 
however, provide scientific evidence to support FDA's conclusion that 
even when stabilized compost or other biological

[[Page 74469]]

materials of animal origin used as feedstock for an agricultural tea 
meet the microbial standards of Sec.  112.55(a) or the microbial 
standard of Sec.  112.55(b), when an agricultural tea additive is used, 
it can result in a final product that contains human pathogens capable 
of causing serious adverse health consequences or death (Ref. 174) 
(Ref. 175) if used as a soil amendment in growing covered produce 
without restriction. In these same studies, when agricultural teas were 
produced using the same compost feedstocks without the addition of 
agricultural tea additives, pathogens were undetectable in the final 
product.
    The scientific body of evidence is inconclusive as to what 
component or components (e.g., soluble carbon content) in agricultural 
tea additives may be contributing to the propagation of human pathogens 
during the production of agricultural teas, so it is difficult for FDA 
to ascertain the significance between 0.2 percent (vol:vol) molasses 
that did not support growth in the Duffy et al. 2004 study and 0.5 
percent (vol:vol) of Soil Soup Additive (contains molasses) in the 
Ingram study that supported pathogen growth. It should be noted that 
Kannangara (2006) noticed a population increase in generic E. coli 
during aerated agricultural tea production amended with only 0.01 
percent molasses, but did document a reduction (but not elimination) of 
generic E. coli in response to the addition of carrot juice extract 
used as an agricultural tea additive. We continue to believe the 
preponderance of evidence supports the conclusion that the use of an 
agricultural tea additive will increase the likelihood of pathogen 
growth in an agricultural tea (of animal origin). However, FDA supports 
innovation and encourages development and scientific evaluation of 
agricultural tea additives that can reliably suppress the growth of, or 
eliminate, foodborne pathogens in agricultural tea. Should consistently 
safe production and use of agricultural tea additives become 
established, we will consider appropriate next steps, including 
possibly revisiting these requirements.
    (Comment 277) Several comments disagree with the proposed 
distinctions related to treated and untreated biological soil 
amendments. These commenters believe that, as proposed, various types 
of biological soil amendments of animal origin (such as static compost, 
vermicompost, compost teas with additives such as molasses or sea kelp, 
and compost that is produced outside of the proposed time and 
temperature requirements) would be treated as raw manure even though, 
in the view of these commenters, such biological soil amendments may 
not pose the same risks as raw manure.
    (Response) We disagree that our requirements would result in all 
the listed biological soil amendments of animal origin being subject to 
the same requirements as raw manure. Section 112.51 distinguishes 
between `treated' and `untreated' biological soil amendments of animal 
origin, and Sec.  112.56 describes the application restrictions that 
apply to biological soil amendments of animal origin depending on 
whether they are treated or untreated (and if treated, depending on 
which level of treatment they received). The provisions of Sec.  112.51 
refer to the treatment processes of Sec.  112.54, which in turn refers 
to the microbial standard provisions of Sec.  112.55. We have revised 
the text throughout Sec.  112.54 to refer to ``biological 
process[es],'' and we use ``composting'' as an example of a biological 
process. Thus, under the revised options for treatment processes in 
Sec.  112.54, this rule classifies the end products of any 
scientifically valid controlled biological processes that have been 
validated to satisfy the microbial standard in Sec.  112.55(a) or (b) 
as ``treated'' biological soil amendments of animal origin (provided 
there is no other reason to consider them untreated under Sec.  
112.51(b), such as contamination after treatment). Therefore, 
stabilized compost produced by static composting processes, end 
products of vermicomposting processes, or stabilized compost produced 
through time/temperature combinations other than those described in 
Sec.  112.54(c)(1) and (2) may be considered ``treated'' provided that 
they meet the requirements of Sec.  112.54, including satisfying one of 
the microbial standards in Sec.  112.55. On the other hand, raw manure 
must be regarded as ``untreated'' under Sec.  112.51. An agricultural 
tea made with biological materials of animal origin that contains an 
agricultural tea additive (such as molasses or sea kelp) is considered 
``untreated'' under Sec.  112.51(b)(5) due to the heightened risk 
presented by the use of such additives (see also Comment 44), and is 
therefore in the same category as raw manure with regard to application 
restrictions in Sec.  112.56.

C. Handling, Conveying, and Storing Biological Soil Amendments of 
Animal Origin (Sec.  112.52)

    As proposed, Sec.  112.52 would establish requirements for 
handling, conveying and storing soil amendments of animal origin. In 
Table 15, we describe the codified provisions of Sec.  112.52 and any 
changes we made to those provisions in the final rule. Comments 
specific to Sec.  112.52 follow the table.

           Table 15--Description of Revisions to Sec.   112.52
------------------------------------------------------------------------
                                                     Final revisions, if
     Proposed provision         Proposed language            any
------------------------------------------------------------------------
Sec.   112.52(a)............  You must handle,      Revised to add other
                               convey, and store     soil amendments and
                               any biological soil   to clarify that
                               amendment of animal   drip fertigation
                               origin in a manner    with agricultural
                               and location such     teas that are
                               that it does not      biological soil
                               become a potential    amendments of
                               source of             animal origin is
                               contamination to      permitted in
                               covered produce,      compliance with
                               food-contact          other requirements
                               surfaces, areas       of this rule.
                               used for a covered
                               activity, water
                               sources, and water
                               distribution
                               systems.
Sec.   112.52(b)............  You must handle,      No change.
                               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.
Sec.   112.52(c)............  You must handle,      Revised.
                               convey, and store
                               any biological soil
                               amendment of animal
                               origin that has
                               become contaminated
                               as if it was
                               untreated.
------------------------------------------------------------------------

[[Page 74470]]

    (Comment 278) One comment states that many farms store animal 
manure purchased from animal production facilities for several months 
before application. The comment maintains that this practice can 
threaten produce safety through potential contamination of water and 
air, just like animal manure stored on adjacent animal production 
facilities.
    (Response) FDA agrees that stored animal manure can be a source of 
contamination. Section 112.52(a) requires biological soil amendments of 
animal origin to be handled, conveyed, and stored in a manner and 
location such that they do not become a potential source of 
contamination to covered produce, food-contact surfaces, areas used for 
a covered activity, water sources, water distribution systems, and 
other soil amendments.
    (Comment 279) One comment interprets Sec.  112.52(a) as forbidding 
drip ``fertigation'' with biological soil amendments of animal origin, 
even if the material is not reasonably likely to contact covered 
produce. The commenter requests that FDA clarify the provision by 
adopting the following edit: ``. . .such that it does not become a 
potential source of contamination to . . . water distribution systems, 
if such contamination may reasonably be likely to result in 
contamination of covered produce.''
    (Response) We did not intend for Sec.  112.52(a) to forbid drip 
fertigation with biological soil amendments of animal origin. 
Biological soil amendments of animal origin may be used in water 
distribution systems in accordance with Sec.  112.56 and their status 
as ``treated'' or ``untreated'' and, if ``treated'', to what standard. 
If ``untreated'' or ``treated'' to the standard in Sec.  112.55(b), 
then the biological soil amendment of animal origin must not contact 
covered produce at application and contact later must be minimized. If 
the biological soil amendment of animal origin is ``treated'' to the 
standard in Sec.  112.55(a), then there are no restrictions on use. We 
are revising Sec.  112.52(a) to add a statement that agricultural teas 
that are biological soil amendments of animal origin may be used in 
water distribution systems provided that all other requirements of this 
rule are met.
    (Comment 280) One comment is concerned that the proposed language 
of Sec.  112.52(c) does not specify the basis for the knowledge or 
suspicion that a soil amendment has become contaminated. The commenter 
recommends FDA make the following change to Sec.  112.52(c) (additions 
underlined): ``(c) You must handle, convey, and store any biological 
soil amendment of animal origin that you know or have reason to believe 
may have become contaminated as if it was untreated.''
    (Response) FDA is making this change. FDA agrees that you should be 
required to regard as ``untreated'' under Sec.  112.51 any biological 
soil amendment of animal origin that you know or have reason to believe 
may have become contaminated, and not only biological soil amendments 
of animal origin that have actually become contaminated. This revision 
makes clear that covered farms must regard biological soil amendments 
of animal origin as untreated as soon as they have information giving 
them reason to believe contamination of the biological soil amendment 
may have occurred.

D. Prohibitions Regarding Use of Human Waste (Sec.  112.53)

    In Sec.  112.53 we proposed to 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. In Table 16, we describe the 
codified provisions of Sec.  112.53 and any changes we made to those 
provisions in the final rule. Comments specific to Sec.  112.53 follow 
the table.

           Table 16--Description of Revisions to Sec.   112.53
------------------------------------------------------------------------
                                                     Final revisions, if
     Proposed provision         Proposed language            any
------------------------------------------------------------------------
Sec.   112.53...............  You may not use       No change.
                               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.
------------------------------------------------------------------------

    (Comment 281) Some comments express concern that FDA's proposed 
rule allowed the use of untreated human waste and biosolids for the 
production of covered produce, even if users were following the EPA 
requirements in 40 CFR part 503, subpart D, or equivalent regulatory 
requirements. Comments express particular concern that the rule would 
allow foreign producers to use human waste as a soil amendment, even 
though their use may not meet EPA standards, and some comments noted 
that farms in some countries have historically used human waste in 
growing produce. Many commenters request that FDA prohibit the use of 
human waste in the production of covered produce. Conversely, at least 
one comment requests that FDA allow for the use and application of 
human waste in the growing of covered produce.
    (Response) Section 112.53 clearly states that the use of human 
waste is prohibited 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. In consultation with 
EPA, FDA has concluded that adherence to 40 CFR part 503 remains an 
appropriate approach to the use of biosolids for the growing of covered 
produce. We continue to believe that these requirements are 
appropriately protective of public health.
    With regard to concerns about ensuring that the provisions are 
followed for imported produce, we note that Sec.  112.53 refers to 
``equivalent regulatory requirements'' to provide for the possibility 
that other competent authorities have established such requirements in 
other jurisdictions. In addition, please see the response to Comment 50 
regarding the provisions of the FSVP regulation. We also note that the 
use of human waste for food production has been addressed by the Codex 
(Ref. 22). FDA plans to conduct outreach activities regarding the 
produce safety rule to help farms understand how to comply (see section 
XXII for additional information).
    (Comment 282) Several comments object to referencing the 
requirements in 40 CFR part 503. A few comments argue that part 503 is 
out of date. One comment points to a National Academy of Sciences 
review of part 503, and argues that the requirements for using human 
waste for growing covered produce should be strengthened in accordance 
with this NAS report, and should use current risk assessment methods. 
One comment questions the validity of the application intervals in part 
503 and expresses concerns about

[[Page 74471]]

the environmental implications of applying biosolids to agricultural 
land.
    (Response) FDA, in consultation with EPA, has determined that 40 
CFR part 503 remains the most appropriate approach to safe use of 
sewage sludge biosolids on land involved in the production of covered 
produce. We point out that the NAS 2002 report (Ref. 177) noted that 
there is ``. . . no documented evidence to indicate that part 503 has 
failed to protect public health''; that EPA responded to the NAS review 
with a 14-point action plan, which it is carrying out; and that under 
section 405(d)(2)(C) of the CWA, EPA is required to publish a biennial 
review of part 503 (Ref. 178). FDA concludes that the provisions of 40 
CFR part 503 are appropriate standards for protecting public health 
with respect to the use of sewage sludge biosolids in growing covered 
produce.
    (Comment 283) A comment requests that source separated human urine 
be classified separately from sewage sludge biosolids, thus allowing it 
to be used in growing covered produce. The comment maintains that human 
urine is sterile, contains bioavailable nutrients, and is an otherwise 
wasted resource that could be important to agriculture and is used in 
other countries as a fertilizer.
    (Response) Urine is not covered by 40 CFR part 503 and, therefore, 
as human waste, Sec.  112.53 prohibits its use in growing covered 
produce. The commenter did not provide data or information from which 
we could conclude that source separated human urine should be allowed 
to be used in growing covered produce, and therefore we are not making 
this change.
    (Comment 284) One comment argues that even if human sewage has been 
adequately treated to be free of pathogens, it would still be 
susceptible to recontamination. This comment suggests that 
recontamination should be explicitly addressed in this rule.
    (Response) FDA's requirement is that sewage sludge biosolids be 
used in accordance with 40 CFR part 503. Under those requirements if 
sewage sludge biosolids that met the standards to be Class A biosolids 
have human waste added to them, they become Class B biosolids and need 
to be used in accordance with the requirements for Class B biosolids. 
However, whether they are Class A or Class B sewage sludge biosolids, 
they may be used in accordance with 40 CFR part 503. Therefore, we do 
not believe that recontamination needs to be explicitly addressed in 
our rule because it is already addressed in 40 CFR part 503 in the 
various standards that apply to sewage sludge biosolids.

E. Treatment Processes (Sec.  112.54)

    Section Sec.  112.54 describes acceptable processes for the 
treatment of biological soil amendments of animal origin to be used for 
growing covered produce. In Table 17, we describe the codified 
provisions of Sec.  112.54 and any changes we made to those provisions 
in the final rule. Comments specific to Sec.  112.54 follow the table.

           Table 17--Description of Revisions to Sec.   112.54
------------------------------------------------------------------------
                                                     Final revisions, if
     Proposed provision         Proposed language            any
------------------------------------------------------------------------
Sec.   112.54...............  Each of the           No change.
                               following treatment
                               processes are
                               acceptable for a
                               biological soil
                               amendment of animal
                               origin that you
                               apply in the
                               growing of covered
                               produce, providing
                               that the resulting
                               biological soil
                               amendments are
                               applied in
                               accordance with the
                               applicable
                               requirements of
                               Sec.   122.56:
Sec.   112.54(a)............  A scientifically      Revised to add
                               valid controlled      biological
                               physical process      processes and
                               (e.g., thermal),      replace
                               chemical process      ``demonstrated''
                               (e.g., high           with ``validated.''
                               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 L.
                               monocytogenes,
                               Salmonella spp.,
                               and E. coli
                               O157:H7;
Sec.   112.54(b)............  A scientifically      Revised to add
                               valid controlled      biological
                               physical process,     processes and
                               chemical process,     replace
                               or combination of     ``demonstrated''
                               scientifically        with ``validated.''
                               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
Sec.   112.54(c)............  A scientifically      First sentence
                               valid controlled      eliminated because
                               composting process    biological
                               that has been         processes meeting
                               demonstrated to       the Sec.
                               satisfy the           112.55(b) standard
                               microbial standard    are now included in
                               in Sec.   112.55(b)   revised Sec.
                               for Salmonella and    112.54(b). Second
                               fecal coliforms.      sentence is now
                               Scientifically        part of Sec.
                               valid controlled      112.54(b) and has
                               composting            been revised to
                               processes include:    refer again to the
                                                     microbial standard
                                                     in Sec.
                                                     112.55(b).
Sec.   112.54(c)(1).........  Static composting     Renumbered to Sec.
                               that maintains        112.54(b)(1) as a
                               aerobic (i.e.,        conforming change
                               oxygenated)           to the combination
                               conditions at a       of Sec.   112.54(b)
                               minimum of 131        and (c); clarified
                               [deg]F (55 [deg]C)    that ``3 days'' is
                               for 3 days and is     consecutive; and
                               followed by           deleted ``which
                               adequate curing,      includes proper
                               which includes        insulation'' as it
                               proper insulation;    is covered by
                                                     adequate curing.
Sec.   112.54(c)(2).........  Turned composting     Renumbered to Sec.
                               that maintains        112.54(b)(2) as a
                               aerobic conditions    conforming change
                               at a minimum of 131   to the combination
                               [deg]F (55 [deg]C)    of Sec.   112.54(b)
                               for 15 days, with a   and (c); revised to
                               minimum of five       state that ``15
                               turnings, and is      days'' does not
                               followed by           have to be
                               adequate curing,      consecutive;
                               which includes        deleted ``which
                               proper insulation;    includes proper
                               or                    insulation'' as it
                                                     is covered by
                                                     adequate curing;
                                                     and deleted ``or''
                                                     at end because Sec.
                                                       112.54(c)(3) is
                                                     deleted.
Sec.   112.54(c)(3).........  Other scientifically  Eliminated as not
                               valid, controlled     necessary. All
                               composting            scientifically
                               processes, provided   valid, controlled
                               you satisfy the       biological
                               requirements of       treatment
                               Sec.   112.12,        processes,
                               including that the    including
                               alternative has       composting, that
                               been demonstrated     meet the microbial
                               to satisfy the        standards of Sec.
                               microbial standard    112.55 are
                               in Sec.               allowable under
                               112.55(b).            revised Sec.
                                                     112.54(a) and (b),
                                                     making the
                                                     allowance for
                                                     alternative
                                                     processes
                                                     unnecessary.
------------------------------------------------------------------------

[[Page 74472]]

    (Comment 285) Some comments states that the rule inappropriately 
treats use of physically and chemically treated soil amendments as less 
risky than soil amendments treated by composting. One comment proposes 
an alternative approach to regulating stabilized compost, including an 
additional process to be added for stabilized compost that 1) meets the 
time and temperature requirements specified in Sec.  112.54(b)(1) and 
(b)(2); and 2) has been demonstrated to satisfy the microbial standard 
in Sec.  112.55(a).
    (Response) FDA agrees that flexibility needs to be added to the 
provisions of Sec.  112.54 to broaden the allowable methods for 
producing stabilized compost that may be regarded as ``treated'' under 
Sec.  112.51 and also to allow farms to regard as ``treated'' 
biological soil amendments of animal origin processed using biological 
processes other than composting, such as vermicomposting, provided that 
such processes meet the microbial standards in either Sec.  112.55(a) 
or (b). We also recognize that the structure of proposed Sec.  112.54 
should be revised to better reflect the application requirements in 
Sec.  112.56, which we proposed to change in our supplemental notice 
without making conforming changes to Sec.  112.54. Thus, we are adding 
options for biological treatment processes (including, but not limited 
to, composting) in Sec.  112.54(a); and collapsing Sec.  112.54(b) and 
(c) to allow for a ``scientifically valid, controlled biological (e.g., 
composting), chemical, or physical process, or combinations thereof, 
that has been demonstrated to satisfy the microbial standard in Sec.  
112.55(b) for Salmonella and fecal coliforms.'' Importantly, because 
these changes retain the requirements that all such treatment processes 
be demonstrated to satisfy either the microbial standards in Sec.  
112.55(a) or (b), we believe these changes address the comments, make 
these provisions as flexible as possible for farms, and provide 
sufficient public health protection.
    (Comment 286) A comment recommends that subpart F, in reference to 
biological soil amendment treatment processes, change the term 
``scientifically valid'' to ``scientifically validated.'' The comment 
recommends this revision to clarify the need for validation of the 
treatment method(s) used to treat biological soil amendments of animal 
origin to meet the microbial standards of Sec.  112.55. The comment 
notes that the need for validation is discussed in the preamble, but 
contends that it should also be explicitly stated in the codified so 
that there is no confusion.
    (Response) We do not agree that we should replace the term 
``scientifically valid'' in this subpart with the term ``scientifically 
validated,'' as these terms have different meanings. However, a 
biological soil amendment of animal origin does not meet the definition 
of ``treated'' per this subpart unless the treatment process is 
scientifically valid and controlled and has been demonstrated (i.e., 
validated) to meet the applicable microbial standards of Sec.  112.55. 
A treatment process that has been demonstrated to satisfy the microbial 
standards of Sec.  112.55 has been validated to meet those microbial 
standards. Therefore, because this comment suggested that there may be 
some confusion on this, we are revising Sec. Sec.  112.54(a) and (b) to 
replace the word ``demonstrated'' with the word ``validated.'' We note 
that consistent with language in other regulations (see the PCHF 
regulation and 21 CFR part 111), we use the term ``scientifically 
valid'' in this rule 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.
    (Comment 287) A comment requests that FDA add the following 
language to Sec.  112.54 ``. . .provided that the resulting biological 
soil amendments meet the microbial standards for the treatment 
processes as stated in Sec.  112.55 and are applied in accordance with 
the applicable requirements of Sec.  112.56...''
    (Response) It is not necessary to add this language to the 
introductory text of Sec.  112.54 as the requirements to meet the 
microbial standards in Sec.  112.55(a) or (b) are contained within the 
provisions of Sec.  112.54(a)-(b). To add the language as suggested by 
the comment would be duplicative.
    (Comment 288) Comments request that, in order to ensure that 
whatever scientifically valid controlled process is chosen by a farm 
(or their supplier) to comply with proposed Sec.  112.54 has been 
effectively followed, FDA add a required ``condition-specific'' 
verification as a requirement in the language of the regulation, which 
would include appropriate microbial testing using scientifically valid 
sampling techniques that include timing and location parameters, to 
establish that the appropriate microbial results stated in the proposed 
Sec.  112.55 have been achieved.
    (Response) FDA is not making this change. As discussed in the 2013 
proposed rule (78 FR 3504 at 3578), FDA is not requiring microbial 
testing of treated biological soil amendments of animal origin to 
ensure that the meet the relevant microbial standards. Rather, we have 
provided the microbial standards against which treatment processes must 
be validated. Proper validation to show that a process satisfies the 
microbial standards of Sec.  112.55 needs to include specific process 
variables, and the person applying the treatment process will need to 
monitor the physical parameters of the process (e.g., the temperature 
of a compost pile) to ensure they meet the conditions under which the 
process was validated. See also our response to Comment 286.
    (Comment 289) One comment suggests there may be a higher risk of 
microbial contamination and a greater threat to public health 
associated with the use of commercial compost than with compost made 
on-farm.
    (Response) FDA is not aware of a greater threat to public health 
from the use of commercial compost than compost made on individual 
farms. The comment did not provide additional information in support of 
this assertion.
    (Comment 290) One comment urges FDA to issue a regulation 
specifically for the use of manure from animal production facilities. 
The comment states that FDA should require animal production facilities 
that sell or give manure to produce farms to take specific steps to 
minimize contamination, including by harmful pathogens, in their animal 
waste.
    (Response) FDA declines this request. While we recognize the risk 
presented by the use of manure in growing of covered produce, manure 
comes from many sources, including from produce farms on which it is 
used. We believe that it is appropriate to focus this rule's 
requirements regarding biological soil amendments of animal origin on 
the operations that are using those materials in the growing of covered 
produce to minimize the risk presented by such uses.
    (Comment 291) Several comments request clarification on whether FDA 
requires testing of individual feedstocks used to prepare an 
agricultural tea, at intervals during the brewing process, or the final 
agricultural tea product, with attention to the fact that by the time 
the tea is applied, the test will no longer be representative of the 
original sample. One comment notes that if an agricultural tea is 
prepared from a stabilized compost feedstock that meets the 
microbiological standard of Sec.  112.55(b), then the remaining 
populations of these microorganisms have the potential to experience 
rapid population growth. The commenter also notes that the 
microbiological criterion

[[Page 74473]]

set in Sec.  112.55 are based on a dry weight (MPN/gram) basis, which 
would not be representative of an agricultural tea, in which the solid 
fraction is mostly removed prior to application.
    (Response) Like other biological soil amendments of animal origin, 
FDA is not requiring that agricultural teas (of animal origin) be 
tested. Rather, for an agricultural tea (of animal origin) to be 
considered ``treated'' for the purposes of Sec.  112.51, the components 
used to make the tea be treated via a process described in Sec.  112.54 
(a) or (b) to meet the microbial standards of Sec.  112.55(a) or (b). 
If a scientifically valid controlled process has been followed, there 
is no need to test the tea to consider it ``treated.'' Agricultural 
teas (of animal origin) that are not treated to such standards, or that 
contain agricultural tea additives or are made with water not meeting 
the requirements in Sec.  112.51(a), must be considered ``untreated'' 
for purposes of Sec.  112.51. With regard to the potential rapid growth 
of pathogens in agricultural teas that meet the microbial standards of 
Sec.  112.55, we note that agricultural teas cannot contain 
agricultural tea additives if they are to be considered ``treated'' for 
purposes of Sec.  112.51, which are the primary contributing factor to 
rapid growth of microflora in teas (Ref. 174). Finally, we agree that 
the proposed microbial standards in Sec.  112.55 were established on a 
dry weight basis, which would not be appropriate for agricultural teas. 
Therefore, we have modified Sec.  112.55 to add a liquid weight basis 
for sampling (for use in validation).
    (Comment 292) At least one comment suggests that stabilized compost 
be regulated according to a two-tier approach, whereby a farm could use 
a zero day application interval if the stabilized compost meets 
stringent criteria, but would have a 45-day interval for stabilized 
compost meeting general safety standards and being used on certain 
covered crops.
    (Response) FDA originally proposed a two-tiered strategy for the 
application interval for use of compost (78 FR 3504). However, in the 
supplemental notice, FDA proposed that all stabilized compost would 
have a zero day application interval (see discussion in 79 FR 58434). 
We are finalizing the provision in Sec.  112.56 for a zero-day interval 
for stabilized compost. Depending on the microbial standards that the 
stabilized compost meets (Sec.  112.55(a) or (b)), the allowable 
application methods differ (compare Sec.  112.56(a)(3) and (a)(2)).
    (Comment 293) A comment requests that FDA focus on compost maturity 
at the time of field application and requested that FDA provide a 
specific definition of ``curing'' along with guidance that would help 
farms ensure adequate pathogen reduction in stabilized compost, prior 
to field application. Several other comments also support requiring a 
curing stage in composting for purposes of considering a biological 
soil amendment of animal origin to be ``treated,'' stating that heating 
manure during the composting process uniformly and to a sufficient 
temperature through one phase of microbial activity is only part of the 
pathogen-control process. Other comments indicate that curing must be 
done in a manner that prevents cross-contamination and which may 
include proper insulation. Some comments express confusion about 
insulation, including the type (some comments suggested the use of a 
plastic tarp) and the timing of insulation (many comments suggested 
compost needs to be turned many times during the compost curing 
process). These comments suggest such use of insulation would be 
neither economically feasible nor operationally practical. Another 
commenter suggests that the specific requirements for use of insulating 
material on compost piles during the curing process are impractical for 
small-farm methods of composting. Some comments indicate that the 
proposed requirement for insulated curing of compost in Sec.  112.54 
(b)(1) and (b)(2) (originally proposed as Sec.  112.54(c)(1) and 
(c)(2)) is overly burdensome and not necessary for all approaches to 
the composting process.
    (Response) Curing is an important part of any type of composting 
process (i.e., static or turned), and reduces pathogens if performed in 
an adequate manner. The definition of ``composting'' in Sec.  112.3(c) 
reflects that curing is an integral part of the process: ``Composting 
means a process to produce stabilized compost 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.'' Curing involves 
the complete decomposition of cellulose and lignin in feedstock such 
that it cannot be further broken down by microbial metabolism. Curing 
may or may not need to include insulation to be adequate to reduce 
pathogens to a specified level, depending on environmental conditions. 
For example, insulation may be needed to ensure that compost 
temperatures do not drop too fast; proper curing involves a gradual 
temperature decline. Thus, we are clarifying the definition of 
``curing'' by adding a statement that ``[c]uring may or may not involve 
insulation, depending on environmental conditions.'' When there is a 
need to protect compost from external temperature changes, a plastic 
tarp would typically not be expected to provide effective insulation. 
Materials such as a layer of straw, hay, or stabilized compost are 
effective for use in insulation.
    We also acknowledge that, for static composting, insulation may 
also be used during the first stage of composting as well as during the 
curing stage. We have made a change to the definition of ``static 
composting'' to reflect this (see Comment 107) such that the definition 
reads, in relevant part, ``[s]tatic composting means a process to 
produce stabilized compost in which air is introduced into biological 
material (in a pile (or row) that may or may not be covered with 
insulating material, or in an enclosed vessel) by a mechanism that does 
not include turning.
    As noted previously, curing may or may not involve insulation. We 
are removing the requirements for proper insulation in Sec.  
112.54(b)(1) and (b)(2) because these provisions are examples of 
scientifically valid controlled biological (e.g., composting) processes 
that meet the microbial standard in Sec.  112.55(b). We agree that 
insulation may not be necessary to meet the microbial standard of Sec.  
112.55(b) under all circumstances and so we have removed the reference 
to insulation in Sec.  112.54(b)(1) and (b)(2). However, those 
employing the static and turned composting processes described in Sec.  
112.54(b)(1) and (b)(2) will need to make a determination whether 
insulation is needed as part of the curing phase to achieve stabilized 
compost.
    (Comment 294) A comment requests clarification regarding whether 
animal manure, or another biological soil amendment of animal origin, 
that is passively composted (that is, simply left in place without 
turning or monitoring) for nine months or more, would be considered 
``untreated'' or ``treated'' for purposes of Sec.  112.51 and 
associated application restrictions in Sec.  112.56. The commenter 
suggests that it would be reasonable to consider manure to be 
``treated'' if it has been aged for a period equal to the proposed 
application interval for untreated biological soil amendments of animal 
origin.
    (Response) Processes that meet the requirements of Sec.  112.54 
must be scientifically valid, controlled processes that have been 
validated to meet the

[[Page 74474]]

microbial standards in either Sec.  112.55(a) or (b). We are not aware 
of any data or information supporting a conclusion that ``passive 
composting'' as described by the commenter (stockpiling or aging 
manure) meets the microbial standards in either Sec.  112.55(a) or (b).
    (Comment 295) One comment asks for a revision to the example 
process provided for ``turned composting'' in Sec.  112.54(b)(2) 
(originally proposed as Sec.  112.54(c)(2)) to read, ``Composting that 
maintains a minimum average temperature of 131[emsp14][deg]F (55 
[deg]C) or higher for 15 days or longer and is followed by adequate 
curing, storage and handling practices. During the period when the 
compost is maintained at 131[emsp14][deg]F (55 [deg]C) or higher, there 
shall be a minimum of five turnings of the windrow with a minimum of 3 
days between turnings. The 15 or more days at or above 
131[emsp14][deg]F (55 [deg]C) do not have to be continuous.''
    (Response) We believe it would be appropriate to make some, but not 
all, of the changes to the example process for ``turned composting'' in 
Sec.  112.54(b)(2) suggested by the commenter. The distinctions between 
our language and that suggested by the comment are: (1) The commenter's 
additional mention of storage and handling; (2) the commenter's 
suggestion of requiring a minimum of 3 days between turnings; and (3) 
the commenter's suggestion that the 15 days need not be continuous.
    With respect to storage and handling, the rule already covers these 
topics sufficiently in Sec.  112.52, and those requirements apply 
equally to all processes used under the rule, including those described 
in Sec.  112.54(b)(2).
    With respect to the commenter's suggestion of requiring a minimum 
of 3 days between turnings, we are not aware of science sufficient to 
support a conclusion that this is required to meet the microbial 
standard in Sec.  112.55(b). Every compost pile has a unique size, 
shape and feedstock composition, all of which affects how the pile will 
generate and maintain heat. For example, many compost windrows will 
reach 55 [deg]C relatively quickly, at which time the operator will 
begin monitoring the `degree days' above this temperature toward 
meeting the fifteen days of exposure to 55 [deg]C per Sec.  
112.54(b)(2). To continue this `thermophilic phase' of the process, the 
operator will typically manage both oxygen and influx of new nutrient 
materials (via turning), and in some situations even moisture, to 
maintain the 55 [deg]C temperature for a total of 15 days to rely on 
the option in Sec.  112.54(b)(2). Turning the piles also serves the 
purpose of maximizing the exposure of as much of the compost material 
as possible to the elevated temperatures. To ensure that as much of the 
compost as possible is exposed to the 55 [deg]C temperature, to rely on 
the option in Sec.  112.54(b)(2), we are requiring a minimum of 5 
turnings but we are not specifying a timeframe for the turns. The 
timing will be driven by the size, shape and feedstock composition. It 
is our understanding that, in order to maintain a compost temperature 
of at least 55 [deg]C for the required 15 days, the operator will 
likely need to turn the windrow approximately three times per week 
(within the first two weeks) and then decrease the frequency to once or 
twice per week for the following month(s) as the compost matures.
    As discussed in response to Comment 293, Sec.  112.54(b)(1) and 
(b)(2) provide two example processes that farms may use to satisfy the 
microbial standard in Sec.  112.55(b), but these are not the only means 
of achieving adequate composting to meet the microbial standard in 
Sec.  112.55(b). Thus, we do not discourage farms from using processes 
that allow a minimum of 3 days between turnings if those processes are 
validated to meet the microbial standards in Sec.  112.55(a) or (b), 
but we are not revising our example process in Sec.  112.54(b)(2) 
because we do not believe it is necessary.
    With respect to the commenter's suggestion that the 15 days need 
not be continuous, we agree that the 15 days at 55 [deg]C need not be 
continuous and, given the nature of turned composting, it is unlikely 
that they would be continuous (Ref. 179). We are revising Sec.  
112.54(b)(2) to indicate that the 15 days at 55 [deg]C need not be 
consecutive. For clarity, we are also revising Sec.  112.54(b)(1) to 
indicate that the 3 days at 55 [deg]C is consecutive. For static 
aerated composting, 3 consecutive days at or above 55 [deg]C ensures 
that the microbial standard in Sec.  112.55(b) is achieved, considering 
the expected die-off rates of various classes of thermophilic and 
thermotolerant pathogens (Ref. 180).
    (Comment 296) One comment asks for confirmation that covered 
produce grown using biological soil amendments of animal origin 
containing pathogens at or below the microbial standards set forth in 
Sec.  112.55(a) and (b) are considered ``safe.''
    (Response) In this regulation, FDA is establishing those standards 
that we conclude minimize the risk of serious adverse health 
consequences or death, including procedures, processes, and practices 
that are reasonably necessary to prevent the introduction of hazards 
into produce, and to provide reasonable assurances that process is not 
adulterated under section 402 of the FD&C Act. We do not expect that 
compliance with these standards will eliminate all occurrences of 
hazards in covered produce.
    (Comment 297) One comment recommends that rather than focusing on 
process standards, which the commenter criticizes as ambiguous, the 
rule should instead require that stabilized compost be tested for 
indicator microbial species to determine appropriate application 
restrictions.
    (Response) FDA disagrees. We have established an approach where we 
define ``treated'' and ``untreated'' biological soil amendments of 
animal origin through the application of a scientifically valid, 
controlled process (described in Sec.  112.54) that has been validated 
to satisfy the microbial standards of either Sec.  112.55(a) or (b). We 
do not agree that such process standards are ambiguous. See discussions 
in Comment 286 and Comment 288. Moreover, we conclude that our approach 
is more protective of public health than relying on lot testing for 
indicator species. Appropriate indicator species in biological soil 
amendments of animal origin may be difficult to identify, and routine 
pathogen testing is not an effective indicator of the presence or 
absence of pathogens. In addition, such testing could require multiple 
target organisms, which could be very costly.
    (Comment 298) Some comments request that accepted treatment 
processes be backed by scientific evidence that they will protect 
public health.
    (Response) As discussed in the 2013 proposed rule (78 FR 3580-1), 
the microbial standards set out in Sec.  112.55 are protective of 
public health. Treatments for biological soil amendments of animal 
origin must be scientifically valid, controlled processes that have 
been validated to satisfy the relevant microbial standard in Sec.  
112.55(a) or (b). In Sec.  112.54(b)(1) and (b)(2) we have described 
processes for static and turned composting that have been previously 
validated to meet the standard in Sec.  112.55(b) for Salmonella and 
fecal coliforms when done properly.
    (Comment 299) Some comments request that FDA require suppliers to 
provide a guarantee to purchasers that a biological soil amendment the 
supplier claims is not of animal origin indeed not include any 
components of animal origin.
    (Response) FDA declines to require provision of such guarantees. 
Soil amendments that do not contain components of animal origin are not 
subject to the requirements in subpart F.

[[Page 74475]]

This rule does not require covered farms to receive such guarantees to 
use soil amendments that are not of animal origin other than as 
provided by subpart F. However, covered farms are responsible for their 
compliance with the rule, and we do not discourage farms from 
requesting such guarantees from their suppliers, which seems likely to 
be a prudent practice.

F. Microbial Standards Applicable to the Treatment Processes in Sec.  
112.54 (Sec.  112.55)

    Section 112.55 establishes microbial standards applicable to the 
treatment processes in Sec.  112.54. In Table 18, we describe the 
codified provisions of Sec.  112.55 and any changes we made to those 
provisions in the final rule. Comments specific to Sec.  112.55 follow 
the table.

           Table 18--Description of Revisions to Sec.   112.55
------------------------------------------------------------------------
                                                     Final revisions, if
     Proposed provision         Proposed language            any
------------------------------------------------------------------------
Sec.   112.55...............  The following         No change.
                               microbial standards
                               apply to the
                               treatment processes
                               in Sec.   112.54 as
                               set forth in that
                               section.
Sec.   112.55(a)............  For L.                No change.
                               monocytogenes,
                               Salmonella species,
                               and E. coli
                               O157:H7, the
                               relevant standards
                               [are those in
                               (a)(1)-(a)(3)] or;
Sec.   112.55(a)(1).........  L. monocytogenes . .  Revised to add
                               . Not detected        liquid sampling.
                               using a method that
                               can detect one
                               colony forming unit
                               (CFU) per 5 gram
                               analytical portion.
Sec.   112.55(a)(2).........  Salmonella species .  Revised to add
                               . . Less than three   liquid sampling and
                               most probable         indicate that it is
                               numbers (MPN) per 4   a `non-detect'
                               grams of total        standard.
                               solids (dry weight
                               basis).
Sec.   112.55(a)(3).........  E. coli O157:H7 . .   Revised to add
                               . Less than 0.3 MPN   liquid sampling and
                               per 1 gram            indicate that it is
                               analytical portion.   a `non-detect'
                                                     standard.
Sec.   112.55(b)............  Less than three MPN   Revised to add
                               Salmonella species    liquid sampling and
                               per four grams of     indicate that the
                               total solids (dry     Salmonella method
                               weight basis); and    is a `non-detect'
                               less than 1,000 MPN   standard.
                               fecal coliforms per
                               gram of total
                               solids (dry weight
                               basis).
------------------------------------------------------------------------

    (Comment 300) One comment suggests that should FDA consider end-use 
risk in establishing final microbial standards for treated biological 
soil amendments of animal origin. The comment pointed to Austrian 
[Ouml]NORM standards for compost, which differ by end-use categories.
    (Response) We believe we have appropriately considered end-use risk 
in establishing the microbial standards for treated biological soil 
amendments of animal origin. First, we note that this rule does not 
apply to end uses such as home gardening or growing crops other than 
covered produce. The end uses to which the requirements of subpart F 
apply are more limited than those in the Austrian standards noted in 
the comment. Second, we conclude that all treated biological soil 
amendments of animal origin must meet the standards in Sec.  112.55(a) 
or (b), and those that meet the standards of Sec.  112.55(b) must also 
be applied in accordance with the restrictions in Sec.  112.56(a)(2). 
We also conclude that untreated biological soil amendments of animal 
origin must be applied in accordance with the restrictions in Sec.  
112.56(a)(1). See Comment 257 regarding our plans for application 
intervals for such biological soil amendments of animal origin.
    (Comment 301) Some comments indicate a belief that the standards in 
proposed Sec.  112.55 are metrics for required microbial testing. The 
comments suggest the use of guidance documents, which can be more 
easily updated, in lieu of incorporating metrics in the provisions of 
the rule.
    (Response) FDA is not requiring microbial testing of treated 
biological soil amendments of animal origin to ensure that they meet 
the relevant microbial standards. Rather, we have provided the 
microbial standards against which treatment processes must be 
validated. Proper validation to show that a process satisfies the 
microbial standards of Sec.  112.55 needs to include specific process 
variables, and the person applying the treatment process will need to 
monitor the physical parameters of the process (e.g., the temperature 
of a compost pile) to ensure they meet the conditions under which the 
process was validated. See also our response to Comment 286. In 
Sec. Sec.  112.54(b)(1) and (b)(2) we have also described processes for 
static and turned composting that have been previously validated to 
meet the standard in Sec.  112.55(b) for Salmonella and fecal coliforms 
when done properly.
    (Comment 302) One comment recommends FDA change the microbial 
standards for Salmonella spp. and E. coli O157:H7 in Sec.  112.55(a) to 
``negative'' or less than detectable limit (<1/30 grams).
    (Response) The microbial standards as proposed in Sec.  112.55(a) 
represented ``less than the detectable limit'' for each pathogen, 
though only Sec.  112.55(a)(1) was phrased as ``not detected using a 
method that can detect . . .'' We are revising the standards in 
Sec. Sec.  112.55(a)(2) and (a)(3) and the Salmonella standard in 
112.55(b) to provide a parallel structure. As revised, Sec.  
112.55(a)(2), (a)(3), and (b) read as set forth in the regulatory text 
of this rule.

G. Application Requirements and Minimum Application Intervals (Sec.  
112.56)

    Section 112.56 establishes application restrictions based on 
whether biological soil amendments of animal origin are treated or 
untreated; and for those biological soil amendments of animal origin 
that are treated, based on the level of treatment they received (with 
reference to the microbial standards in Sec.  112.55). In Table 19, we 
describe the proposed codified provisions of Sec.  112.56 (considering 
the 2013 proposed rule and the supplemental notice, taken together) and 
any changes we made to those provisions in the final rule. Comments 
specific to Sec.  112.56 follow the tables.

[[Page 74476]]

         Table 19--Description of Revisions to Sec.   112.56(a)
------------------------------------------------------------------------
                                                     Final revisions, if
     Proposed provision         Proposed language            any
------------------------------------------------------------------------
Sec.   112.56(a)............  Except as provided    Deleted ``Except as
                               in paragraph (b) of   provided in
                               this section, you     paragraph (b) of
                               must apply the        this section'' as a
                               biological soil       conforming change
                               amendments of         to the deletion of
                               animal origin         (b) (made in the
                               specified in the      supplemental
                               first column of the   notice).
                               table in this        Revised (a)(1)-(4)
                               paragraph in          to (a)(1)-(3).
                               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
                               [table follows
                               containing (1)-(4)].
------------------------------------------------------------------------

    Proposed Sec.  112.56(a)(1)-(4) was published at 78 FR 3504, 
January 16, 2013.
    Final Sec.  112.56(a)(1)-(3) is set forth in the regulatory text of 
this rule.
    The revisions in final Sec.  112.56(a)(1)-(3) consist of conforming 
amendments to match changes made in Sec.  112.54 (including biological 
processes in both Sec.  112.54(a) and (b), and collapsing Sec.  
112.54(b) and (c)); and to renumber proposed (a)(2) as (a)(3).
    (Comment 303) Several comments request that FDA clarify the 
meanings of ``does not contact,'' and ``minimizes contact.'' Some 
comments suggest that the phrase ``In a manner that does not contact 
covered produce during or after application'' might be read to require 
that there is absolutely no possibility of contact of the soil 
amendment with the covered produce, and one comment suggested that such 
a requirement could never be met in light of the variety of activities 
performed on farms and the potential that dust from fields may contact 
covered produce. Another comment seeks clarification on whether the 
harvestable portion of underground crops would be considered to come 
into contact with the biological soil amendments of animal origin used 
on the soil.
    (Response) FDA intends ``does not contact'' in Sec.  112.56 to mean 
there is no intended or likely contact between the biological soil 
amendment of animal origin and covered produce during the relevant time 
period. For example, when an amendment is applied beneath a high tree 
crop that is not intentionally dropped to the ground for harvest, there 
would be no intended or likely contact either during or after 
application. We do not agree with the comment suggesting that a ``does 
not contact'' requirement could never realistically be met. We realize 
that there is always a chance that some soil amendment could be present 
in dust such that it settles on covered produce; however, we do not 
believe at this time that this type of potential contact is significant 
enough to be considered intended or likely for purposes of Sec.  
112.56. However, we intend to include consideration of wind-blown 
contamination in our upcoming risk assessment on untreated biological 
soil amendments of animal origin (See discussion under Comment 257).
    FDA intends ``minimizes contact'' to mean there is no intended 
contact between the biological soil amendment of animal origin and 
covered produce during the relevant time period, but some unintentional 
contact is likely due to incidental or environmental action. For 
example, a farm choosing to side-dress a leafy green crop with a soil 
amendment in the alley between crop rows could apply the amendment in a 
manner that does not contact the covered produce at application. 
However, it would be likely that some portion of the amendment would 
migrate to the area where the crop is located. This post-application 
contact would not be intended, but it is likely. Conversely, if the 
farm were to apply the soil amendment in the previous example not in 
the alley between crop rows but instead in a broadcast manner, it could 
be reasonably expected that there would be widespread contact between 
the amendment and the harvestable portion of the leafy greens both 
during and after application, and that such contact is both intentional 
and likely.
    A root crop grown in soil that has been amended with biological 
soil amendments of animal origin is both intended and likely to be in 
contact with those soil amendments both during and after application.
    We will consider addressing this topic further in our forthcoming 
implementation guidance.
    (Comment 304) Some comments state that use of raw manure should be 
subject to additional application restrictions beyond those in Sec.  
112.56(a)(1)(i) and (a)(1)(ii) because there is risk even if the manure 
is applied in such a way that there is no intended or likely contact 
with covered produce, noting that there will always be opportunities 
for indirect contact from forces such as wind and dust. These comments 
provide several references to support their conclusion that raw manure 
poses a significant risk to covered produce.
    (Response) As discussed in response to Comment 257, FDA is pursuing 
a risk assessment and research agenda to supplement the science on an 
appropriate application-to-harvest interval for raw manure. FDA will 
consider the information provided by these comments during future risk 
assessment and research efforts. We agree that raw manure can be an 
important route of contamination for covered produce and encourage 
farms to consider use of stabilized compost as an alternative to raw 
manure.

H. Records Related to Biological Soil Amendments of Animal Origin 
(Sec.  112.60)

    Section 112.60 requires that you establish and keep records for 
subpart F in accordance with the requirements of subpart O of this part 
and that you establish and keep certain records. In Table 20, we 
describe the codified provisions of Sec.  112.60 and any changes we 
made to those provisions in the final rule. Comments specific to Sec.  
112.60 follow the table.

           Table 20--Description of Revisions to Sec.   112.60
------------------------------------------------------------------------
                                                     Final revisions, if
     Proposed provision         Proposed language            any
------------------------------------------------------------------------
Sec.   112.60(a)............  You must establish    No change.
                               and keep records
                               required under this
                               subpart F in
                               accordance with the
                               requirements of
                               subpart O of this
                               part.

[[Page 74477]]

 
Sec.   112.60(b)............  For any biological    No change.
                               soil amendment of
                               animal origin you
                               use, you must
                               establish and keep
                               the following
                               records:
Sec.   112.60(b)(1).........  For a treated         Revision to
                               biological soil       eliminate proposed
                               amendment of animal   (1)(ii) and as a
                               origin you receive    conforming change
                               from a third party,   to renumber
                               documentation (such   (1)(iii) to (1)(ii)
                               as a Certificate of   and to require such
                               Conformance) that:    documentation at
                              (i) The process used   least annually.
                               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 risk
                               of contamination by
                               an untreated or in
                               process biological
                               soil amendment of
                               animal origin.
Sec.   112.60(b)(2).........  For a treated         No change.
                               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.
Sec.   112.60(b)(3).........  Scientific data or    Elimination of Sec.
                               information you        112.60(b)(3) as a
                               rely on to support    conforming change
                               a process used to     since Sec.
                               treat a biological    112.54(c)(3) has
                               soil amendment of     been deleted.
                               animal origin in
                               accordance with the
                               requirements of
                               Sec.   112.54(c)(3).
------------------------------------------------------------------------

    (Comment 305) One comment requests clarification on what compost 
suppliers should document to ensure covered farms could rely on such 
documentation to satisfy the rule and on documentation needed when 
using alternative composting procedures. Another comment asks us to 
clarify the requirements for records related to process verification in 
composting.
    (Response) With regard to documentation that a farm receives from a 
third party, such as a stabilized compost supplier, we have revised the 
proposed requirements. We are sensitive to requests that we minimize 
the burden of testing. Therefore, we are eliminating proposed Sec.  
112.60(b)(1)(ii) that would have required documentation of testing of 
treated biological soil amendments of animal origin received from third 
parties to verify that the treatment process satisfies the applicable 
microbial standard in Sec.  112.55 and the results of the periodic 
testing. We consider such periodic verification testing to be a best 
practice, but we conclude it is not necessary to mandate that farms 
maintain documentation of such testing performed by their suppliers. We 
are requiring in Sec.  112.60(b)(1)(i) that, with respect to treated 
biological soil amendments of animal origin received from a third 
party, covered farms must maintain documentation demonstrating that 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. Parameters will be process specific and 
may include, for example, time/temperature, moisture content, and pH. 
We are also renumbering proposed Sec.  112.60(b)(1)(iii) to Sec.  
112.60(b)(1)(ii) and maintaining the requirement, as proposed, that 
with respect to treated biological soil amendments of animal origin 
received from a third party, covered farms must maintain documentation 
that the biological soil amendment of animal origin has been handled, 
conveyed, and stored in a manner and location to minimize the risk of 
contamination by an untreated or in process biological soil amendment 
of animal origin.
    Regarding documentation that a farm producing its own treated 
biological soil amendment of animal origin must have, in accordance 
with Sec.  112.60(b)(2) a farm must have documentation that process 
controls (for example, time, temperature and turnings) were achieved. 
As a conforming change to the elimination of Sec.  112.54(c)(3), we are 
eliminating proposed Sec.  112.60(b)(3) which would have required 
records documenting the scientific data or information relied on to 
support any alternative composting process used to treat biological 
soil amendments of animal origin in accordance with Sec.  112.54(c)(3).
    (Comment 306) Several comments agree with FDA's decision to require 
certain documentation for any treated biological soil amendment of 
animal origin received from a third party. These comments stated this 
was consistent with established industry programs. Other commenters 
suggest that requiring certificates of conformance will be economically 
burdensome to compost suppliers, and requested clarification on how 
often such documentation would need to be obtained from a supplier.
    (Response) FDA agrees that documentation, meeting the requirements 
in Sec.  112.60(b)(1) should be required for a treated biological soil 
amendment of animal origin that you receive from a third party. Note 
that FDA proposes ``such as a Certificate of Conformance'' in the 
codified language only to serve as one possible example of adequate 
documentation. Any form of documentation is acceptable provided that it 
includes the information required in Sec.  112.60(b)(1); it need not be 
named a ``Certificate of Conformance.'' We disagree with the comment 
suggesting that such documentation is economically burdensome as we 
understand that such documentation is already frequently provided and 
is consistent with industry standards. Documentation must be obtained 
from third-party suppliers at least annually. We are adding the annual 
requirement to the codified in Sec.  112.60(b)(1).

[[Page 74478]]

    (Comment 307) Some comments suggest that, in order to best protect 
consumers from the risk of pathogens, FDA should require adequate 
recordkeeping for application intervals for all biological soil 
amendments of animal origin, whether treated or untreated, and without 
regard to whether produce contacts the soil.
    (Response) FDA agrees that robust recordkeeping is a best practice. 
However, FDA disagrees that it is reasonably necessary to require 
covered farms to maintain records of dates of application and harvest 
when they use biological soil amendments of animal origin that have a 
required application interval of zero days as described in Sec.  
112.56, which at this time includes all biological soil amendments of 
animal origin. Should FDA establish application intervals greater than 
zero days for any uses of biological soil amendments of animal origin 
at a later date, we will also establish appropriate recordkeeping 
requirements related to those intervals. See Comment 257 regarding our 
plans on this topic.
    (Comment 308) One comment states that FDA should require farms to 
document the particular fields on which biological soil amendments of 
animal origin received from a supplier are applied. This comment states 
that such a requirement could help facilitate traceback investigations 
if problems are identified, and may help limit the scope of a recall or 
product withdrawal.
    (Response) While we agree that this information could be useful in 
some very limited circumstances, we do not agree that it is reasonably 
necessary to establish such a requirement to minimize the risk of 
serious adverse health consequences or death, to prevent the 
introduction of hazards into or onto produce, or to provide reasonable 
assurances that produce is not adulterated under section 402 of the 
FD&C Act. We will consider addressing this topic in guidance.

I. Other Comments

    (Comment 309) Several comments address our request regarding how to 
classify 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). 
Some comments argue that spent mushroom mulch should not be defined as 
a biological soil amendment of animal origin regardless of the contents 
of its feedstock because it is processed with a steam treatment after 
the mushrooms are harvested and it originally met the microbial 
standards of Sec.  112.55(a) prior to use in growing mushrooms. These 
comments argue that spent mushroom mulch should have no restrictions on 
its use. On the other hand, many comments agree with FDA's tentative 
conclusion that if the spent mushroom mulch has been subject to a 
treatment process which met the microbial standard in Sec.  112.55(a), 
it would still be considered a ``treated'' biological soil amendment 
after use for growing mushrooms and therefore available for use as 
``treated'' in growing any covered produce commodity 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.
    (Response) FDA disagrees with the commenters that argued that spent 
mushroom mulches or other spent growth media should not be defined as 
biological soil amendments of animal origin, when it was defined as 
such before it was used. We conclude that if a substrate such as spent 
mushroom mulch previously met the requirements to be considered a 
``treated'' biological soil amendment of animal origin under Sec.  
112.51, then it retains that status after use as a growth media, unless 
you know or have reason to believe it has been otherwise contaminated 
with a hazard or has been associated with foodborne illness.

XV. Subpart I--Comments on Domesticated and Wild Animals

    In subpart I of proposed part 112, we proposed science-based 
minimum standards that are directed to domesticated and wild animals. 
As proposed, subpart I included standards that would be directed to the 
potential for biological hazards from animal excreta to be deposited by 
your own domesticated animals (such as livestock, working animals, and 
pets), by domesticated animals from a nearby area (such as livestock 
from a nearby farm), or by wild animals (such as deer and wild swine) 
on covered produce or in an area where you conduct a covered activity 
on covered produce. We requested comment on all provisions in subpart 
I, including specifically on the scope of the subpart's proposed 
applicability, including the meaning of the phrase ``under the 
circumstances'' and our tentative conclusion that crops that grow 
completely underground would not be subject to the proposed 
requirements of subpart I. We also requested comment on the 
interactions of the proposed provisions of subpart I with the NOP.
    In addition, in the supplemental notice, taking into account 
comments on the 2013 proposed rule, we proposed Sec.  112.84 to state 
that part 112 does not authorize or require covered farms to take 
certain actions. We asked for comment on our current thinking, 
including on proposed Sec.  112.84 (79 FR 58434 at 58463-58464).
    We solicited additional comments on the potential impact of the 
proposed produce safety rule on wildlife and animal habitat. We 
considered these comments in our EIS (see section XXVII of this 
document. In this section of this document we discuss comments we 
received on the standards directed to wild or feral animals and 
domesticated animals, in the 2013 proposed rule, but that we did not 
address in the supplemental notice. We discuss comments received on 
proposed Sec.  112.84 in the supplemental notice in section III.E of 
this document.
    We are finalizing these provisions with revisions (see Table 21). 
We discuss these changes in this section. We are finalizing the other 
provisions of subpart I without change.

   Table 21--Description of Re-Arrangement and Revisions to Subpart I
------------------------------------------------------------------------
    Proposed provision  (as
 proposed in the 2013 proposed                         Description of
    rule and amended in the      Final provision         revisions
     supplemental notice)
------------------------------------------------------------------------
Sec.   112.81.................  Sec.   112.81....  --Revision to Sec.
                                                    112.81(b) to state
                                                    that subpart I does
                                                    not apply to fish
                                                    used in aquaculture
                                                    operations.

[[Page 74479]]

 
Sec.   112.82.................  Sec.   112.83....  --Revision to combine
                                                    and unify
                                                    requirements related
                                                    to grazing and
                                                    working animals and
                                                    animal intrusion.
                                                   --Revision to require
                                                    farms to assess
                                                    relevant areas and
                                                    take certain steps
                                                    to prevent covered
                                                    produce that is
                                                    reasonably likely to
                                                    be contaminated
                                                    when, under the
                                                    circumstances, there
                                                    is a reasonable
                                                    probability that
                                                    grazing animals,
                                                    working animals, or
                                                    animal intrusion
                                                    will contaminate
                                                    covered produce.
                                                   --Revision to clarify
                                                    that Sec.   112.83
                                                    applies during the
                                                    growing season, in
                                                    contrast to the
                                                    related Sec.
                                                    112.112, which
                                                    applies during and
                                                    immediately prior to
                                                    harvest.
                                                   --Revisions to
                                                    further clarify what
                                                    type of evidence of
                                                    potential
                                                    contamination
                                                    requires a covered
                                                    farm to take action
                                                    under Sec.   112.83
                                                    (observation of
                                                    significant
                                                    quantities of
                                                    animals, significant
                                                    amounts of animal
                                                    excreta, or
                                                    significant crop
                                                    destruction), and
                                                    what kind of action
                                                    is required
                                                    (evaluate whether
                                                    the covered produce
                                                    can be harvested and
                                                    take measures
                                                    reasonably necessary
                                                    during growing to
                                                    assist you later
                                                    during harvest when
                                                    you must identify,
                                                    and not harvest,
                                                    covered produce that
                                                    is reasonably likely
                                                    to be contaminated
                                                    with a known or
                                                    reasonably
                                                    foreseeable hazard.
Sec.   112.83
Sec.   112.84.................  Sec.   112.84....  --No change.
------------------------------------------------------------------------

A. Subpart I and Prevention of Contamination

    (Comment 310) Some comments suggest that FDA should address 
contamination of produce from domesticated and wild animals through 
postharvest processing or treatment (including steps such as washing) 
rather than requiring measures to prevent contamination of covered 
produce with fecal material.
    (Response) We disagree that postharvest processing or treatments 
provide viable options for addressing the potential for contamination 
of covered produce by domesticated or wild animals. Produce that 
receives commercial processing that adequately reduces the presence of 
microorganisms of public health significance is eligible for exemption 
from this rule with certain documentation under Sec.  112.2(b). In 
addition, produce that is rarely consumed raw (i.e., it is typically 
cooked before consumption) is not subject to this rule under Sec.  
112.2(a). Thus, by definition, covered produce is produce that is not 
likely to receive a postharvest processing or a treatment step that 
will adequately reduce the presence of microorganisms of public health 
concern. As discussed in the 2013 proposed rule, 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. 181) (Ref. 182) (Ref. 183). In 
addition, 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. 184) (Ref. 185). Thus, our rule 
takes an approach consistent with the requirement in section 
419(c)(1)(A) that this regulation set forth the procedures, processes, 
and practices the Secretary determines to be reasonably necessary to 
prevent the introduction of known or reasonably foreseeable hazards 
into fruits and vegetables.

B. Limited Scope of Applicability of Subpart I (Sec.  112.81)

    (Comment 311) Several comments support limiting the applicability 
of subpart I to outdoor areas and partially-enclosed buildings, and not 
to fully-enclosed buildings. In contrast, some comments express 
concerns about intrusion by pests in both fully- and partially-enclosed 
buildings, and suggest that the scope of subpart I be expanded to 
include fully-enclosed buildings for this reason. One commenter 
believes we exempted activities that take place in fully enclosed 
buildings from subpart I on the basis that mammals and other carriers 
of human pathogens are less likely to come into contact with produce 
that is grown in controlled areas.
    (Response) We are maintaining the limitation on applicability of 
subpart I to outdoor areas and partially-enclosed buildings, as 
proposed. We are not expanding the applicability of subpart I to fully-
enclosed buildings. We identified mammals (such as cows, dogs, swine, 
and deer) as examples, and not to suggest that these are the only 
animals that can be a potential source of contamination of covered 
produce. We acknowledge that domesticated animals and intrusion by 
pests can be potential hazards for covered activities that take place 
in fully-enclosed buildings, and we are establishing requirements 
addressing these hazards in subpart L of part 112. Specifically, 
measures directed at domesticated animals in a fully-enclosed building 
are described under Sec.  112.127, and requirements regarding pest 
control in both fully-enclosed and partially-enclosed buildings are 
described under Sec.  112.128. We have also revised Sec.  112.181(b) to 
reflect that subpart I does not apply to fish used in aquaculture 
operations (See Comment 17).
    (Comment 312) One comment disagrees with our tentative conclusion 
that there would not be a reasonable probability of contamination by 
animals when covered produce grows completely underground, and that 
therefore such produce would not be subject to the requirements in 
subpart I. This comment stated that different scenarios of animal 
interaction with produce operations entail different levels of risk, 
and that it may not be appropriate to harvest covered produce grown 
underground in areas where there is a prolonged, high concentration of 
animals known to be vectors of key human pathogens, and suggested that 
the provisions of subpart I should apply under such circumstances.
    (Response) We agree that there may be situations in which even 
produce that grows completely underground should not be harvested as a 
result of wild animal activity, e.g., if the produce is visibly 
contaminated with animal excreta. We are revising both Sec.  112.112 
and Sec.  112.83 to make explicit when and how these provisions apply 
and how they differ from each other, clarifying

[[Page 74480]]

that Sec.  112.112 applies immediately prior to and during harvest, 
while Sec.  112.83 applies during the growing season. The requirement 
in Sec.  112.112 of subpart K requires covered farms 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 produce that is visibly 
contaminated with animal excreta. At a minimum, identifying and not 
harvesting covered produce that is reasonably likely to be contaminated 
with animal excreta or that is visibly contaminated with animal excreta 
requires a visual assessment of all covered produce to be harvested, 
regardless of the harvest method used. This requirement (Sec.  112.112) 
applies even to covered produce grown completely underground and FDA 
concludes that it is sufficient to address the majority of potential 
scenarios in which animals may contaminate covered produce grown 
completely underground.
    For example, section 112.112 requires farms to take steps to 
identify and not harvest covered carrots that are reasonably likely to 
be contaminated, including carrots that are visibly contaminated with 
animal excreta. At a minimum, with respect to animal excreta, this 
requires a covered farm to conduct a visual assessment of the growing 
area and all covered produce to be harvested, regardless of the harvest 
method used. Underground produce that is not visible prior to harvest 
must be visually assessed during harvest to comply with this 
requirement. If, during your assessment of the growing area or of the 
covered carrots, you see evidence of animal excreta on or surrounding a 
carrot, you must not harvest that carrot; and you must not harvest an 
area of carrots if animal excreta that is present in the growing area 
would be likely to contaminate carrots or food-contact surfaces of 
harvest equipment. By contrast, the requirements in subpart I include 
assessing relevant areas for evidence of potential contamination of 
covered produce as needed during the growing season, with required 
follow-up actions to be taken during the growing season if evidence of 
potential contamination is found (Sec.  112.83). FDA concludes it is 
not necessary to apply the additional requirements in subpart I to 
covered produce that grows completely underground because the growth 
habit of such commodities means that there will not be a reasonable 
probability of contamination of such commodities by animals as a 
general matter. We acknowledge that there is a rare and limited range 
of potential scenarios in which animals may contaminate covered produce 
grown completely underground during the growing season but where no 
evidence of such contamination would be visible immediately prior to or 
during harvest of that produce. For example, it is theoretically 
possible that pigs may root in a field of carrots, exposing those 
carrots to potential contamination from the pigs' excreta, and weather 
events may remove the evidence of the pigs' activity prior to harvest. 
However, we do not think this rare and limited scenario presents a 
reasonable probability of contamination during the growing season as a 
general matter that warrants application of the additional requirements 
in Sec.  112.83 during the growing season. Our QAR, too, suggests 
limited concerns of contamination of such underground produce from 
animals during the growing of these produce. Given the limited chance 
that animals will contaminate covered produce that grows completely 
underground in a manner not visible at harvest such that appropriate 
measures may be taken at that time, we do not think it is necessary to 
require covered farms to take the measures required in subpart I with 
respect to such produce. We emphasize, however, that covered produce 
commodities that grow completely underground will be subject to the 
rest of this rule, as applicable, including Sec.  112.112. We note that 
even covered produce grown completely underground is reasonably 
vulnerable to contamination with known or reasonably foreseeable 
hazards during and after harvest, as harvesting exposes such produce to 
contamination through various pathways. Thus, we conclude that it is 
warranted to apply Sec.  112.112 even to covered produce grown 
completely underground. We also emphasize that covered produce 
commodities that do not grow completely underground (for example, 
spinach or tomatoes) are subject to the requirements of subpart I.
    (Comment 313) One comment asserts that occasional animal intrusions 
should not represent a threat for the harvest of apples, in particular, 
given that the fruit is located above the ground while it grows and is 
typically hand-harvested, suggesting that such produce should not be 
subject to subpart I.
    (Response) We cannot draw a categorical conclusion with regard to 
the applicability of subpart I to all tree crops that grow high above 
the ground and are hand-harvested. Animal intrusion is outside the 
farm's control, and may include intrusion by significant quantities of 
birds that may, in some circumstances, be reasonably likely to 
contaminate such crops. There may be circumstances in which subpart I 
does not apply to such crops, and there will likely be circumstances in 
which subpart I does apply to such crops. That determination must be 
based on the farm's specific circumstances.

C. Grazing and Working Animals (Sec.  112.83)

    (Comment 314) Some comments request that FDA clarify what would be 
considered an adequate waiting period under proposed Sec.  112.82(a) 
and request that FDA specify a minimum waiting period between grazing 
of animals in a field and harvest of covered produce from that field. 
Some comments suggest that FDA should not require a waiting period 
between grazing and harvesting, or that certain commodities should not 
be subject to such a requirement. Several comments express concern 
about the ability of farmers who employ diversified crop-livestock 
farming systems that integrate or rotate livestock farming and produce 
growing to comply with proposed Sec.  112.82(a). Several comments 
express concerns with FDA's statement in the 2013 proposed rule that we 
would not expect it to be necessary for an adequate waiting period 
between grazing and harvest to exceed 9 months, which was the 
application interval we proposed for use of raw manure as a soil 
amendment in originally proposed Sec.  112.56(a)(1)(i). In contrast, 
other commenters recommend that FDA require a waiting period of nine 
months. One comment asks whether a visual evaluation of the presence of 
fecal material, as required in certain situations under Sec.  112.83 
relating to wildlife, could be used to satisfy the requirements of 
proposed Sec.  112.82(b) for working animals. Several comments noted 
the importance of working animals to farm operations and expressed 
concerns about how farmers who rely on working animals would comply 
with proposed Sec.  112.82(b). For example, some comments suggest that 
Sec.  112.82(b) may limit the use of working animals such as horses 
used for tilling and harvest activities and transporting produce, 
stating that it would be difficult to maintain a designated path 
completely segregated from growing produce to be used by draft animals 
such as working horses. Some comments express concerns about whether 
proposed Sec.  112.82(b) would prevent covered farms from using dogs, 
cats, or chickens to deter pests in growing areas; or prevent farms 
from

[[Page 74481]]

using guard dogs to keep other animals out of fields.
    (Response) We are removing Sec.  112.82 from the rule and replacing 
it with revised requirements related to grazing and working animals in 
Sec.  112.83, discussed further in the paragraphs that follow. FDA 
continues to believe that an adequate waiting period between grazing 
and harvest is an important consideration when, under the 
circumstances, there is a reasonable probability that grazing animals 
will contaminate covered produce. As discussed in the 2013 proposed 
rule and our QAR, domesticated animals can be a source of human 
pathogens. Some human pathogens of public health concern (e.g., E. coli 
O157:H7) that have been associated with produce-related foodborne 
outbreaks are zoonotic. Moreover, domesticated animals, due to their 
close proximity and interaction with humans, are generally more likely 
to harbor zoonotic pathogens than are wild animals (Ref. 186). The 
likelihood of contaminating produce with human pathogens from excreta 
from grazing animals is determined by numerous factors, including, but 
not limited to, the species of the animal and its association with 
human or domesticated animal activity or waste, the number of animals 
per unit area of land, agro-ecological conditions, the type of 
commodity and the time period between animal grazing in fields and the 
harvest of produce (Ref. 187) (Ref. 188) (Ref. 189) (Ref. 190) (Ref. 
191).
    However, currently available science does not allow us to identify 
a specific minimum time period between grazing and harvesting that is 
generally applicable across various commodities and farming practices. 
Rather, the appropriate minimum time period between grazing and 
harvesting would need to be determined based on the specific factors 
applicable to the conditions and practices associated with growing and 
harvesting the commodity. We are eliminating the proposed requirement 
for an adequate waiting period between grazing and harvesting in 
proposed Sec.  112.82(a). However, we encourage covered farms to 
voluntarily consider applying such waiting periods, as appropriate for 
the farm's commodities and operations. We will consider providing 
guidance on this practice in the future, as needed.
    In response to comments suggesting that the assessment strategy in 
proposed Sec.  112.83 was a reasonable approach not only to the risk of 
animal intrusion, but also to the risk posed by working animals, we 
evaluated applying that strategy more broadly to grazing animals, 
working animals, and animal intrusion. We have concluded that such an 
approach was reasonable, scientifically sound, and simpler than 
establishing different requirements based on different types of animal 
activity. Therefore, we are removing the proposed requirements for a 
waiting period between grazing and harvesting in relation to grazing 
animals (proposed Sec.  112.82(a)) and measures to prevent introduction 
of hazards from working animals into or onto covered produce (proposed 
Sec.  112.82(b)), and we are adopting an approach that unifies the 
requirements addressing the potential for contamination from grazing 
animals, working animals, and animal intrusion. Under revised Sec.  
112.83, we are requiring that you take the same steps if, under the 
circumstances there is a reasonable probability that grazing animals, 
working animals, or animal intrusion will contaminate covered produce 
(Sec.  112.83(a)). In such cases, you must assess the relevant areas 
used for a covered activity for evidence of potential contamination of 
covered produce as needed during the growing season (based on your 
covered produce; your practices and conditions; and your observations 
and experience) (Sec.  112.83(b)(1)). If you find evidence of potential 
contamination during that assessment (such as observation of 
significant quantities of animals, significant amounts of animal 
excreta, or significant crop destruction), you must evaluate whether 
the covered produce can be harvested in accordance with the 
requirements of Sec.  112.112, and you must take measures reasonably 
necessary during growing to assist you later during harvest when under 
Sec.  112.112 you must identify, and not harvest, covered produce that 
is reasonably likely to be contaminated with a known or reasonably 
foreseeable hazard (Sec.  112.83(b)(2)).
    Assessing the growing areas as needed during the growing season 
will enable you to identify instances when covered produce cannot be 
harvested for safe consumption, such as 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). Depending on the 
quantity of animals, extent of animal excreta, or extent of crop 
destruction, the affected growing areas may be localized (for example, 
a specific area of the field where you allowed grazing) or more 
widespread. We expect that, in cases of grazing and working animals, in 
particular, it is more likely that affected areas will be localized 
because grazing or working animals are expected to be present 
intermittently and in known areas of the field. Once you identify 
produce, or an area of produce, that cannot be harvested in accordance 
with Sec.  112.112, Sec.  112.83(b)(2) requires you to take measures 
reasonably necessary during growing to assist you later during harvest 
in complying with the requirements of Sec.  112.112. For example, if 
you have identified an area with significant animal excreta that is 
likely to cross-contaminate any covered produce harvested from that 
area such that the area may not be harvested, you could mark that area 
in a manner that will ensure it is not harvested, even if weather 
events or other occurrences remove the animal excreta so it is not 
visible later during harvest. For example, you might mark such an area 
by placing flags outlining the affected area. This provides additional 
protection in the event that the evidence of animal intrusion or other 
animal activity is no longer visible by the time of harvest, such as if 
a significant rain event washes away fecal deposits.
    FDA recognizes the longstanding co-location of animals and plant 
food production in agriculture. This rule does not prohibit the use of 
grazing or working animals on covered farms. We believe this approach 
addresses concerns regarding the feasibility of compliance with the 
rule for farms that rely on grazing animals (such as integrated or 
diversified farms with crop-livestock rotation systems) and farms that 
rely on working animals for various purposes, including horses, dogs, 
cats, and chickens. Under revised Sec.  112.83, farms would be required 
to apply the same approach to any of these uses of animals, and only if 
under the circumstances there is a reasonable probability that animals 
will contaminate covered produce (Sec.  112.83(a)). Farms in such 
circumstances must assess the relevant areas as needed during the 
growing season (Sec.  112.83(b)(1)), and if evidence of potential 
contamination is found, evaluate whether the covered produce can be 
harvested and take measures reasonably necessary to assist the farm 
later during harvest in identifying and not harvesting affected covered 
produce (Sec.  112.83(b)(2)). We also note that Sec.  112.83, like the 
rest of this rule, applies only to covered produce. Farms may graze 
animals on growing areas used for crops other than covered produce, or 
use working animals in such areas, without triggering Sec.  112.83. We 
will consider providing guidance on issues related to integrated or

[[Page 74482]]

diversified farming practices in the future, as needed.
    (Comment 315) One comment suggests that farmers should be 
prohibited from cultivating covered produce and grazing animals on the 
same soil.
    (Response) FDA believes this suggestion goes beyond what is 
reasonably necessary to minimize the risk of serious adverse health 
consequences or death, to prevent the introduction of known or 
reasonably foreseeable hazards into or onto produce, and to provide 
reasonable assurances that produce is not adulterated under section 402 
of the FD&C Act. We acknowledge the longstanding co-location of animals 
and plant food production in agriculture, and we do not believe it is 
necessary to prohibit grazing in areas where covered produce is grown 
to achieve the statutory purposes set forth in section 419 of the FD&C 
Act. We are requiring farms to assess relevant areas used for a covered 
activity as needed during the growing season for evidence of potential 
contamination, to evaluate whether produce can be safely harvested, and 
to take measures reasonably necessary during growing to assist the farm 
later during harvest when the farm must identify, and not harvest, 
covered produce that is reasonably likely to be contaminated with a 
known or reasonably foreseeable hazard when, under the circumstances, 
there is a reasonable probability that grazing animals, working 
animals, or animal intrusion will contaminate covered produce (Sec.  
112.83). We believe this rule requires an appropriate level of public 
health protection while also appropriately providing sufficient 
flexibility considering the diversity of production and harvesting of 
produce (sections 419(a)(3)(A) and (c)(1)(B) of the FD&C Act).
    (Comment 316) Some comments suggested that proposed Sec.  112.82(a) 
would require covered farms to implement a waiting period every time 
they suspected that a domesticated or wild animal had intruded upon a 
growing area, and expressed concern that such a requirement would lead 
to a de facto requirement for farms to exclude wildlife from areas 
where covered produce is grown.
    (Response) We are eliminating proposed Sec.  112.82(a) for the 
reasons discussed in response to Comment 314. In addition, to remove 
any possible confusion, FDA has added Sec.  112.84 to the rule 
explicitly stating that the rule does not require covered farms to take 
measures to exclude animals from outdoor growing areas, or to destroy 
animal habitat or otherwise clear farm borders around outdoor growing 
areas or drainages.
    (Comment 317) Some comments ask that FDA clarify that working 
animals are permitted in growing areas and that terminating the use of 
working animals is not necessary to comply with the regulation.
    (Response) Working animals are permitted in growing areas, and the 
regulation does not require termination of the use of working animals 
on covered farms. As discussed in response to Comment 314, we are 
revising requirements related to working animals, now established in 
Sec.  112.83. Revised Sec.  112.83 does not prohibit the use of working 
animals on covered farms. Therefore, covered farms can use working 
animals provided that the farm complies with Sec.  112.83, as 
applicable.
    (Comment 318) One comment suggests requiring domesticated animals 
to be vaccinated.
    (Response) We do not agree that we should specifically require 
vaccination of domesticated animals on covered farms, including working 
animals. We are not aware of currently available vaccines that would 
prevent animal excreta from containing human pathogens, and the comment 
did not provide information from which we could conclude that such 
vaccines are available.

D. Animal Intrusion (Sec.  112.83)

    (Comment 319) In response to the 2013 proposed rule, several 
comments express support for the monitoring requirement in proposed 
Sec.  112.83, and assert that the proposed provisions provide 
sufficient flexibility to accommodate regional, operational, and 
commodity diversity in farming operations, and are consistent with 
current industry practices. On the other hand, several comments argue 
that proposed Sec.  112.83 would be impracticable or burdensome. Some 
of these comments state that any requirement to monitor for animal 
intrusion is untenable, particularly in the case of monitoring for 
birds on open-air farms. Such comments argue that farms would not be 
able to prevent all wildlife interaction with covered produce or detect 
every animal intrusion that occurs and, therefore, no reasonable effort 
to monitor animal intrusion could provide assurance that covered 
produce is not contaminated or adulterated. Some comments suggest FDA 
should use an ``outcome-based approach'' to animal intrusion, and 
suggest that monitoring of crop during harvest as set out in Sec.  
112.112 is the most appropriate control point at which to ensure 
contaminated produce is excluded. These comments appear to argue that 
monitoring as required by proposed Sec.  112.83, during the growing 
season and immediately prior to harvest, is unnecessary in light of the 
requirements of Sec.  112.112 that apply immediately prior to and 
during harvest.
    (Response) We disagree with comments that state that monitoring for 
evidence of animal intrusion is burdensome or impracticable. As 
discussed in the preamble of the 2013 proposed rule, periodic 
monitoring for evidence of animal intrusion and deposition of their 
excreta is a reasonably 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 such assessment during the growing season is a 
practical and reasonably necessary standard to sufficiently ensure that 
potential hazards related to animal intrusion are identified for 
appropriate follow-up actions, including the requirements that apply 
immediately prior to and during harvesting in Sec.  112.112. Section 
112.83 provides flexibility for farmers to consider the nature of their 
covered produce, their practices and conditions, and their observations 
and experience to determine when and how often to assess the relevant 
areas during the growing season when there is a reasonable probability 
that animals will contaminate covered produce (see Sec.  112.83(b)(1)). 
We do not expect the requirements of Sec.  112.83 to, as one comment 
suggested, prevent all wildlife interaction with covered produce or 
detect every animal intrusion that occurs. We have added a new 
provision, Sec.  112.84, to make explicit that this rule does not 
require exclusion of wild or feral animals from covered farms. By 
``wild'' animals we refer to those animals living in a state of nature 
and not ordinarily tamed or domesticated, and by ``feral'' animals we 
refer to those that have escaped from domestication and become wild. In 
the title of subpart I, ``Domesticated and Wild Animals,'' we use the 
term ``wild'' to refer collectively to both wild and feral animals. 
These provisions are intended to provide you with information about 
animal movements on your farm, allow you to recognize significant 
animal intrusion, and facilitate your taking appropriate measures 
following significant animal intrusion without being unduly 
restrictive.
    As discussed in response to Comment 314, Sec. Sec.  112.83 and 
112.112 are

[[Page 74483]]

complementary rather than duplicative, and we have revised them to 
remove overlap and clarify how they are different from each other, as 
well as revising Sec.  112.83 to apply to grazing animals, working 
animals, and animal intrusion. We have deleted requirements from 
proposed Sec.  112.83 that would have applied ``immediately prior to 
harvest'' and limited its application to ``during the growing season.'' 
By contrast, Sec.  112.112 is a generally applicable requirement that 
applies immediately prior to and during harvest activities. We are 
revising both Sec. Sec.  112.83 and 112.112 to make this distinction 
clear. We believe that Sec.  112.83 adds an important level of public 
health protection beyond the general harvest-related requirement in 
Sec.  112.112, and that the additional requirements of Sec.  112.83 
should apply whenever, under the circumstances, there is a reasonable 
probability that grazing animals, working animals, or animal intrusion 
will result in contamination of covered produce. Under such 
circumstances, covered farms must do more than just identify and not 
harvest covered produce that is reasonably likely to be contaminated 
based on observations made during and immediately prior to harvest 
(Sec.  112.112). In these situations, covered farms must take proactive 
steps under Sec.  112.83 to assess relevant areas during the growing 
season for evidence of potential contamination. Moreover, if such 
evidence is found (such as significant quantities of animals, 
significant amounts of animal excreta, or significant crop 
destruction), Sec.  112.83 requires covered farms to evaluate whether 
covered produce can be harvested and take measures reasonably necessary 
during growing to assist the farm later during harvest when the farm 
must identify and not harvest, covered produce that is reasonably 
likely to be contaminated with a known or reasonably foreseeable 
hazard. For example, if you have identified an area with significant 
animal excreta that is likely to cross-contaminate any covered produce 
harvested from that area such that the area may not be harvested, you 
could mark that area in a manner that will ensure it is not harvested, 
even if weather events or other occurrences remove the animal excreta 
so it is not visible later during harvest. For example, you might mark 
such an area by placing flags outlining the affected area. This 
provides additional protection in the event that the evidence of animal 
intrusion or other animal activity is no longer visible by the time of 
harvest, such as if a significant rain event washes away fecal 
deposits.
    We understand that when covered produce is grown in an outdoor 
environment, wild or feral animals are likely to have access to 
production fields. We reiterate that the presence of animals in a 
production field of covered produce, in and of itself, is not a 
significant food safety risk. However, wild or feral animals are known 
zoonotic disease reservoirs for human pathogens, and therefore their 
excreta may contaminate growing covered produce crops (Ref. 186) (Ref. 
188). Therefore, we conclude that assessing for evidence of potential 
contamination and taking appropriate follow-up actions, as described in 
Sec.  112.83, is a reasonably necessary when, under the circumstances, 
there is a reasonable probability that animals will contaminate covered 
produce. We note that, as discussed in our response to Comment 314, not 
all circumstances present a reasonable probability that animals will 
contaminate covered produce, such that not all covered farms or growing 
areas will be subject to the requirements in Sec.  112.83.
    (Comment 320) Some comments request that any requirements for 
recordkeeping related to animal intrusion be eliminated from the 
regulation. In contrast, one comment suggests requiring records to be 
maintained in relation to the requirements in subpart I.
    (Response) Part 112 does not include requirements for establishing 
or maintaining records related to subpart I. We do not believe such a 
requirement is warranted, although we encourage covered farms to 
prepare and keep documentation as appropriate to facilitate their 
implementation of the provisions of subpart I. Therefore, a covered 
farm is not required to develop or keep a record of its activities 
related to assessment for animal intrusion.
    (Comment 321) One comment suggests that FDA add a requirement that 
covered farms take reasonable measures to keep animals out of growing 
areas and water sources based on the farm's observations from 
assessment for animal intrusion.
    (Response) We do not believe it is necessary to establish such a 
requirement in subpart I. The presence of animals in a production field 
of covered produce, in and of itself, is not a significant food safety 
risk. We believe that assessing for animal intrusion and taking 
appropriate follow-up actions, as described in Sec.  112.83, is an 
appropriate approach to ensure the safety of covered produce when, 
under the circumstances, there is a reasonable probability that animal 
intrusion will contaminate covered produce. Moreover, Sec.  112.42(c) 
requires covered farms to adequately maintain all agricultural water 
sources that are under the farm's control (such as wells), including 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.
    (Comment 322) One comment requests that FDA define more 
specifically the time period that would be appropriate for fulfilling 
the proposed requirement in proposed Sec.  112.83(a)(2) to monitor for 
animal intrusion ``immediately prior to harvest.''
    (Response) We are eliminating the phrase ``immediately prior to 
harvest'' in Sec.  112.83. As described in response to Comment 314, 
revised Sec.  112.83 applies during the growing season. We are, 
however, retaining similar language in Sec.  112.112. As discussed in 
section XVI.B of this document, we use ``immediately prior to harvest'' 
in Sec.  112.112 to refer to the time period prior and as close to 
commencing harvesting as is practicable.
    (Comment 323) One comment suggests that FDA consider including in 
the regulation the CA LGMA Animal Hazard/Fecal Matter Decision Tree.
    (Response) We are aware that some decision-making tools, such as 
the CA LGMA Animal Hazard/Fecal Matter Decision Tree (the CA LGMA 
animal hazard decision tree) and the Cornell University National GAPs 
Program Wildlife and Animal Management Decision Tree (the Cornell 
animal management decision tree), are intended to help covered farms 
evaluate their fields for signs of animal intrusion and take follow-up 
action. Although these may be useful resources, we find the information 
and variables addressed in these tools to be more prescriptive than we 
consider necessary in this rule, and not necessarily applicable across 
all commodities and agro-ecological conditions. For example, the CA 
LGMA animal hazard decision tree is commodity-specific and tailored 
specifically for leafy greens operations in California. We decline to 
incorporate these decision-making tools into this regulation as 
requirements.
    (Comment 324) Some comments argue that the requirements of proposed 
Sec.  112.83 are vague and request that FDA provide guidance regarding 
methods for evaluating potential contamination of produce and 
determining if it is safe to harvest.

[[Page 74484]]

    (Response) As discussed in section XVI of this document, we have 
revised Sec.  112.112 to provide more specificity regarding the 
evaluation that is necessary during and immediately prior to harvest to 
identify and not harvest covered produce that is reasonably likely to 
be contaminated with animal excreta or that is visibly contaminated 
with animal excreta. At a minimum, this requires a visual assessment of 
the growing area and all covered produce to be harvested, regardless of 
the harvest method used. We also explain in that section that this may 
be achieved by, for example, visually examining each article of produce 
and surrounding areas immediately prior to harvesting the article of 
produce by hand; or by conducting a visual assessment of all of the 
growing area and the produce in the growing area to be harvested 
immediately prior to the start of mechanical or hand harvesting. For 
example, if you identify an article of covered produce that is visibly 
contaminated with excreta, you may not harvest that article of covered 
produce (e.g., watermelon with cow feces on it). As another example, if 
you identify an area with significant animal excreta that is likely to 
cross-contaminate any covered produce harvested from that area, the 
covered produce in that area may not be harvested (e.g., a ``no harvest 
zone'' in an area of a spinach field containing wild hog feces).
    Section 112.83 applies during the growing season rather than during 
or immediately prior to harvest. It requires an additional step during 
the growing season applicable only when under the circumstances there 
is a reasonable probability that grazing animals, working animals, or 
animal intrusion will contaminate covered produce. In such cases, 
covered farms must assess relevant areas used for a covered activity 
for evidence of potential contamination. This requires a visual 
assessment of all of the relevant areas used for a covered activity 
(including growing areas and any other areas in which there is a 
reasonable probability of contamination of covered produce from 
animals) and the covered produce. If evidence of potential 
contamination is found (such as significant quantities of animals, 
significant amounts of animal excreta, or significant crop 
destruction), Sec.  112.83(b)(2) requires covered farms to evaluate 
whether covered produce can be harvested. This evaluation described in 
Sec.  112.83(b)(2) is the same type of evaluation described in Sec.  
112.112, but under Sec.  112.83(b)(2) an evaluation is also performed 
earlier, during the growing season. This evaluation requires a farm 
that becomes aware of potential contamination to evaluate affected 
areas and produce, and to take appropriate measures to facilitate its 
identification of produce that may not be harvested later in the season 
(such as marking affected areas or produce, as discussed in response to 
Comment 314).
    (Comment 325) Some comments suggest that farms should be required 
to evaluate whether their covered produce can be harvested in 
accordance with Sec.  112.112 upon finding any evidence of animal 
intrusion; suggesting that the phrase ``significant quantities of'' in 
proposed Sec.  112.83(b) should be removed.
    (Response) We disagree. As noted previously, we do not expect the 
requirements of Sec.  112.83 to detect every animal intrusion that 
occurs or to require farms to take measures in response to every such 
intrusion. The requirements of Sec.  112.83 are intended to provide you 
with information about animal movements on your farm, allow you to 
recognize significant animal intrusion, and facilitate your taking 
appropriate measures following significant animal intrusion without 
being unduly restrictive. We believe that the harvest-related 
requirement in Sec.  112.112 provides sufficient protection to address 
less than significant animal intrusion (i.e., intrusion that occurs 
without the farm observing, during required assessment, significant 
quantities of animals, significant animal excreta, or significant crop 
destruction).
    (Comment 326) One comment suggests that, for tree crops, covered 
farms should be required to cover and remove animal excreta from the 
harvest area so that it does not contaminate workers or equipment. 
Other comments suggest that covered farms should be required to cordon 
off areas of ground crops where potential contamination may have 
occurred as a result of animal intrusion and ensure that covered 
produce is not harvested from those areas.
    (Response) Specific determinations about whether certain covered 
produce can be harvested, and what specific measures to take to assist 
the farm later during harvest will likely vary dependent on the 
specific circumstances relevant to the commodity and/or the farm's 
practices, procedures, and processes. The requirements of Sec.  112.83 
and related Sec.  112.112 are purposefully flexible, to allow covered 
farms to take steps in compliance with those requirements that are most 
appropriate to their operations, in light of their covered produce and 
the nature of their covered activities. We note that section 
419(c)(1)(D) of the FD&C Act directs us to minimize, as appropriate, 
the number of separate standards that apply to separate foods. We 
believe it is appropriate to establish one standard addressing the risk 
of contamination of covered produce from grazing animals, working 
animals, and animal intrusion, which is applicable whenever under the 
circumstances there is a reasonable probability that animals will 
contaminate covered produce. Therefore, we decline to establish more 
specific requirements such as those suggested by the comments. We will 
consider providing more specific recommendations with respect to how 
farms may implement these requirements for specific situations in the 
Produce Safety Regulation implementation guidance, which we expect to 
issue in the near term. We agree that the practices suggested by the 
commenters may be appropriate strategies for compliance with Sec.  
112.83, depending on the circumstances.
    (Comment 327) One comment maintains that the provisions should 
differentiate between produce that is hand-harvested and that harvested 
by a machine. The comment urges FDA to create a less stringent standard 
with respect to animal intrusion for producers who employ hand 
harvesting, noting that a machine cannot detect animal intrusions or 
animal excreta and, therefore, the presence of animals on large-scale 
farms that employ machine harvesting poses a significantly different 
level of risk than on farms that use hand harvesting.
    (Response) As discussed in section XVI of this document, we have 
revised Sec.  112.112 to provide more specificity regarding the 
evaluation that is necessary during and immediately prior to harvest to 
identify and not harvest covered produce that is reasonably likely to 
be contaminated with animal excreta or that is visibly contaminated 
with animal excreta. At a minimum, this requires a visual assessment of 
the growing area and all covered produce to be harvested, regardless of 
the harvest method used. We also explain in that section that this may 
be achieved by, for example, visually examining each article of produce 
and surrounding areas immediately prior to harvesting the article of 
produce by hand; or by conducting a visual assessment of all of the 
growing area and the produce in the growing area to be harvested 
immediately prior to the start of mechanical or hand harvesting. Thus, 
we have revised Sec.  112.112 to address the differences between hand 
harvesting and machine harvesting with respect to the ability to detect 
evidence of

[[Page 74485]]

potential contamination. We have also revised Sec.  112.83 to specify 
that it applies only during the growing season and not during or 
immediately prior to harvest. Thus, we do not consider it to be 
necessary to take into account harvesting practices in Sec.  112.83 
because we consider that they are sufficiently addressed in Sec.  
112.112.
    (Comment 328) Several comments express concern that proposed Sec.  
112.83 could be perceived as requiring measures to exclude wildlife 
from growing areas. Citing concerns that some on-farm food safety 
certification programs have resulted in farmers' abandoning 
conservation practices and actively excluding wildlife from farms, some 
comments ask FDA to explicitly clarify that the regulation does not 
require producers to exclude wild animals from the growing area. Some 
comments express concern that this proposed provision can be 
interpreted to conflict with other federal and State programs to 
establish buffer zones or other natural vegetation buffer strips 
intended to improve water quality, protect endangered species, and 
enhance wildlife habitat.
    (Response) We believe that these concerns have been addressed 
through our addition of Sec.  112.84, as discussed in the supplemental 
notice.

E. List of ``Animals of Concern''

    (Comment 329) Several commenters express support for FDA's 
tentative conclusion to not establish a list of ``animals of concern,'' 
agreeing that current scientific evidence is inadequate to develop such 
a list. On the other hand, some comments request FDA to establish a 
list of ``animals of concern'' to assist farms in determining the risk 
of animal intrusion in growing area. One such comment states that some 
research indicates that certain types of animals are not routine 
carriers of specific pathogenic organisms.
    (Response) We continue to find that currently available scientific 
data and information are insufficient to develop a list of specific 
animals that present the greatest risk for pathogens. The commenters 
that requested us to establish such a list did not provide specific 
scientific research or data in support of their request. Therefore, we 
decline the request to establish a list of ``animals of concern.''

XVI. Subpart K--Comments on Growing, Harvesting, Packing, and Holding 
Activities

    In subpart K of proposed part 112, we proposed 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. We asked 
for comment on our proposed provisions, including proposed Sec.  
112.114 related to dropped produce; and proposed Sec.  112.115 related 
to measures to prevent formation of botulinum toxin.
    We are finalizing these provisions with revisions (see Table 22). 
We discuss these changes in this section. We are finalizing the other 
provisions of subpart K as proposed.

                                 Table 22--Description of Revisions to Subpart K
----------------------------------------------------------------------------------------------------------------
                Final provision                                      Description of revisions
----------------------------------------------------------------------------------------------------------------
Sec.   112.111(a)..............................  --Revision to add ``(except when covered produce and excluded
                                                  produce are placed together in the same container for
                                                  distribution)'' to make our intent clear that this provision
                                                  does not preclude the placing together of covered and excluded
                                                  produce in containers for distribution, such as in gift
                                                  baskets.
Sec.   112.112.................................  --Revision to clarify that Sec.   112.112 applies during and
                                                  immediately prior to harvest, in contrast to the related Sec.
                                                   112.83, which applies during the growing season.
                                                 --Revision to specify that ``[a]t a minimum, identifying and
                                                  not harvesting covered produce that is reasonably likely to be
                                                  contaminated with animal excreta or that is visibly
                                                  contaminated with animal excreta requires a visual assessment
                                                  of the growing area and all covered produce to be harvested,
                                                  regardless of the harvest method used.''
Sec.   112.113.................................  --Revision to add the phrase ``to the degree practicable''
                                                  considering covered commodities that are harvested near the
                                                  soil line, where avoiding contact of cut surfaces of harvested
                                                  produce with soil may not be practicable.
Sec.   112.114.................................  --Revisions to clarify meaning of ``dropped covered produce,''
                                                  including explicitly state that dropped covered produce does
                                                  not include root crops (such as carrots) that grow
                                                  underground, crops (such as cantaloupe) that grow on the
                                                  ground, or produce that is intentionally dropped to the ground
                                                  as part of the harvesting method (such as almonds).
                                                 --Deletion of ``unless it is exempt under Sec.   112.2(b)'' as
                                                  confusing and unnecessary.
Sec.   112.115.................................  --No change.
Sec.   112.116.................................  --Revision to Sec.   112.116(a) to clarify that food-packing
                                                  materials used must be adequate for their intended use, which
                                                  includes being: (1) Cleanable or designed for single use and
                                                  (2) unlikely to support growth or transfer of bacteria.
                                                 --Revision to Sec.   112.116(b) to remove the reference to
                                                  ``sanitizing'' and to make clear the steps taken, including
                                                  the frequency of cleaning or replacing liners, must be
                                                  adequate.
----------------------------------------------------------------------------------------------------------------

A. Growing, Harvesting, Packing, or Holding Both Covered and Excluded 
Produce (Sec.  112.111)

    (Comment 330) Some comments generally express support for this 
provision. Some comments request further clarification regarding the 
requirement to keep covered produce separate from produce not covered 
under this rule. One commenter suggests defining ``separate'' as 
``preventing the ability of cross-contamination by separating in space 
so that covered and non-covered produce is not in direct contact with 
one another.'' Another commenter asks FDA to explain how this 
requirement would apply to covered and excluded produce items that are 
sold together, as in the case of gift baskets. This commenter asks 
whether gift baskets with other ingredients such as chocolate, would be 
covered under this rule, and whether the place where the non-produce 
item is originally packed is a factor is this determination.
    (Response) Section 112.111 requires covered farms to keep covered 
produce separate from excluded produce (that is

[[Page 74486]]

not grown, harvested, packed or held in accordance with part 112) 
during growing, harvesting, packing, and holding as applicable, to 
avoid physical contact between the two categories so as to minimize 
risk of transfer of pathogens from one to the other. We do not believe 
it is necessary to define the term ``separate;'' as used in this 
provision, we believe the common meaning of this term to be 
sufficiently descriptive for the purposes of conveying the intent of 
this requirement.
    For the purposes of part 112, covered produce includes not only 
fruits and vegetables, but also mixes of intact fruits and vegetables 
(see Sec.  112.1(b)(2)). However, it was not our intent to preclude the 
placing together of covered and excluded produce in containers for 
distribution, such as in gift baskets. We are revising Sec.  112.111(a) 
to make this intent clear. This provision also does not prevent you 
from placing covered produce into the same container (such as a gift 
basket) with other food items not covered under part 112. Excluded 
produce and/or other food items not covered under part 112 must adhere 
to all other applicable requirements under the FD&C Act. In addition, 
to the extent the establishment that assembles the basket or package is 
a mixed-type facility (including a farm mixed-type facility) or other 
facility that is required to register with FDA, such an establishment 
may be subject to the requirements of part 117, the PCHF regulation.

B. Harvesting Covered Produce (Sec.  112.112)

    (Comment 331) Some comments cite specific circumstances where 
contamination is likely and request clarification regarding applicable 
requirements under Sec.  112.112. One comment argues that produce is 
likely to be contaminated with animal excreta when a flock of birds 
land on an iceberg lettuce field, and should not be harvested under 
Sec.  112.112 although the excreta may not be visible. According to 
this commenter, some farms may routinely harvest produce that has been 
in contact with fecal material if the outer layers of the fruit or 
vegetable can be removed before depositing it into the harvest 
container, as in the case of lettuce. The commenter is concerned that, 
in such instances, all surfaces that come in contact with excreta may 
not have been identified or removed. Another comment points to an 
instance where covered produce comes into contact with water that is 
thought to be contaminated, and suggests that such produce should not 
be harvested under Sec.  112.112.
    (Response) Section 112.112 requires covered farms to take all 
reasonably necessary measures to identify, and not harvest, produce 
that is reasonably likely to be contaminated with a known or reasonably 
foreseeable hazard. See section IX of this document for a discussion of 
the definition of ``known or reasonably foreseeable hazard.'' We have 
revised Sec.  112.112 to clarify when and how this provision applies, 
and to distinguish it from the related Sec.  112.83. See our discussion 
of Sec.  112.83 in section XV of this document. Section 112.112 applies 
immediately prior to and during harvest, while Sec.  112.83 applies 
during the growing season. Section 112.112 applies generally to covered 
farms with respect to all covered produce, while Sec.  112.83 only 
applies when under the circumstances there is a reasonable probability 
that animals will contaminate covered produce. Section 112.112 applies 
generally to all covered produce that is reasonably likely to be 
contaminated with any known or reasonably foreseeable hazards covered 
under this rule, while Sec.  112.83 applies only when the reasonably 
likely source of contamination is animal activity.
    Within Sec.  112.112, we explicitly identify as an example one 
known or reasonably foreseeable hazard in relation to harvest 
activities, i.e., pathogens are likely to be introduced into or onto 
covered produce by animal excreta when it is present. Thus, one 
important aspect of Sec.  112.112 is that it requires farms to identify 
and not harvest covered produce that is reasonably likely to be 
contaminated with animal excreta, or that is visibly contaminated with 
animal excreta. We are clarifying in the text of Sec.  112.112 that 
identifying and not harvesting covered produce that is reasonably 
likely to be contaminated with animal excreta or that is visibly 
contaminated with animal excreta requires a visual assessment of all 
covered produce to be harvested, regardless of the harvest method used. 
This may be achieved by, for example, visually examining each article 
of produce and surrounding areas immediately prior to harvesting the 
article of produce by hand; or by conducting a visual assessment of all 
of the growing area and the produce in the growing area to be harvested 
immediately prior to the start of mechanical or hand harvesting. 
Underground produce that is not visible prior to harvest must be 
visually assessed during harvest to comply with this requirement.
    Section 112.112 includes, but is not limited to, visibly 
contaminated articles of covered produce. For example, you would comply 
with this provision by not harvesting a head of lettuce if you see 
excreta on the head of lettuce. As another example, if you see 
significant evidence of crop destruction from animal activity in an 
area of your field of carrots, you would comply with this provision by 
not harvesting the carrots from that area of the field, even if some of 
the carrots (not grazed on) may be intact, to the extent that these 
carrots, too, are reasonably likely to be contaminated as a result of 
the animal activity.
    Section 112.112 requires that these actions be taken ``immediately 
prior to and during harvest.'' We use the term ``immediately prior to . 
. . harvest'' in Sec.  112.112 to refer to the time period prior and as 
close to commencing harvesting as is practicable. We expect that in 
most cases covered farms will choose to take steps to identify covered 
produce that may not be harvested ``immediately prior to harvest,'' 
although this step may also be done during harvest. The required visual 
examination is most effective when done as close in time before 
beginning harvesting as is practicable, under the circumstances of the 
farm's operation, or during harvesting itself. We are not specifying 
the exact time period when such visual assessment must be done, given 
the practicability of such assessment is dependent, in part, on the 
farm's operation and commodity.
    In addition to potential pathogen contamination from animal 
activity, there may be other known or reasonably foreseeable hazards 
that a covered farm would need to identify and address under Sec.  
112.112. We consider, for example, the circumstance a commenter raised 
where covered produce may come into contact with water that is likely 
to be contaminated with pathogens. In subpart E, we are establishing 
requirements related to agricultural water, including that all 
agricultural water must be safe and of adequate sanitary quality for 
its intended use (Sec.  112.41). Subpart E provides the relevant 
requirements for what farms must do when agricultural water does not 
meet this standard (Sec.  112.45(a)), or other specific microbial 
quality criteria we are establishing for certain uses (Sec. Sec.  
112.45(a) and (b)), and therefore, we do not believe additional 
standards are needed under Sec.  112.112 with respect to harvesting 
based on agricultural water quality. Circumstances may arise, however, 
in which water that is likely to be contaminated with known or 
reasonably foreseeable hazards, such as flood water, contacts covered 
produce. Flood water is outside the definition of agricultural water 
established in this rule and is

[[Page 74487]]

therefore not subject to the requirements in subpart E. However, both 
Sec. Sec.  112.11 and 112.112 apply to flooding situations. In 
accordance with Sec.  112.11, covered farms 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 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. Moreover, in 
accordance with Sec.  112.112, a covered farm that has experienced 
flooding will be required to assess the extent of flooding and not 
harvest covered produce that is reasonably likely to be contaminated 
with known or reasonably foreseeable hazards through contact with flood 
water.
    (Comment 332) One commenter suggests revising Sec.  112.112 to 
provide that ``harvesting covered produce that is visibly contaminated 
with excreta should be avoided to the extent practicable.''
    (Response) We disagree with the suggestion to revise Sec.  112.112 
to provide that ``harvesting covered produce that is visibly 
contaminated with excreta should be avoided to the extent 
practicable.'' 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, we conclude that covered 
produce that is visibly contaminated with animal excreta must not be 
harvested. Accordingly, Sec.  112.112 requires that you take all 
measures reasonably necessary to identify and not harvest produce that 
is reasonably likely to be contaminated with a known or reasonably 
foreseeable hazard. Section 112.112 further specifies, to remove any 
possible confusion, that this includes taking steps to identify and not 
harvest covered produce that is visibly contaminated with animal 
excreta. For these reasons, we are not making the requested change.

C. Handling Harvested Covered Produce (Sec.  112.113)

    (Comment 333) One commenter recommends that we include the 
following types of explicit and specific requirements in Sec.  112.113, 
and that such requirements should also be commodity-specific: ideal 
harvest time of day, postharvest chill requirement, chill temperature, 
wash requirement(s), wash specifications, and ideal storage 
temperature(s). In addition, noting that many produce commodities cut 
during harvest grow near or in contact with the soil, the commenter 
questions the feasibility of the example provided in Sec.  112.113, 
i.e., ``by avoiding contact of cut surfaces of harvested produce with 
soil,'' and suggests revising it by adding the phrase ``to the degree 
practicable.''
    (Response) Due to the diversity of covered produce commodities and 
our desire to allow appropriate flexibility, FDA is not establishing 
commodity-specific handling requirements for harvested produce in this 
rule. We note, however, that FDA is working on certain commodity-
specific guidance documents. We have issued draft guidances for 
tomatoes, melons, and leafy greens and will consider developing 
guidances covering other commodities.
    With respect to the comment about the example listed within Sec.  
112.113, we agree that adding the phrase ``to the degree practicable'' 
is appropriate, considering covered produce commodities that are 
harvested near the soil line, such as herbs and celery, where avoiding 
contact of cut surfaces of harvested produce with soil may not be 
practicable. However, Sec.  112.113 requires covered farms to handle 
harvested covered produce in a manner that protects against 
contamination with known or reasonably foreseeable hazards, including 
pathogens that may be present in soil. This includes taking all 
measures that are reasonably necessary and practicable.
    Accordingly, we are revising Sec.  112.113 to read as set forth in 
the regulatory text of this rule.
    (Comment 334) Several comments support our tentative conclusion not 
to require washing of produce after harvesting. Some of these comments 
acknowledge that disinfectants added to wash water cannot be expected 
to kill all pathogens that may be present on produce, and may also 
accelerate decomposition of certain commodities.
    (Response) In light of these comments, and in the absence of new 
data or factual information, we are not establishing any requirement to 
wash harvested produce in this rule. Wash water, with or without an 
active antimicrobial agent, does not completely disinfect produce that 
may contain microorganisms of public health significance (Ref. 181) 
(Ref. 182) (Ref. 183). 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. 184) (Ref. 185). 
As appropriate, farms may choose to wash covered produce, and to add 
safe and suitable disinfectants to wash water, according to label 
instructions, to reduce the likelihood of produce contamination, 
including for example to help prevent the cross-contamination of 
surrounding produce with any pathogens that may be introduced into the 
wash water from a single fruit or vegetable.
    (Comment 335) Specifically in the context of harvested produce, one 
comment requests FDA to require facilities handling ``high-risk'' 
produce to periodically test the finished product for pathogens, and 
cites cantaloupe as an example of a produce commodity that should be 
subject to such a requirement.
    (Response) In the 2013 proposed rule (78 FR 3504 at 3533), we 
discussed the challenges associated with requiring microbiological 
product testing, either routinely or under specific conditions, as a 
strategy to minimize known or reasonably foreseeable hazards in covered 
produce. We have no new information suggesting that we should change 
our conclusion, nor did this commenter provide any new data or factual 
information. Therefore, we are not establishing a requirement for 
microbiological product testing of covered produce, except as 
established in subpart M under certain circumstances for sprouts (Sec.  
112.144(b) and (c)). See section III.F of this document.

D. Dropped Covered Produce (Sec.  112.114)

    In Sec.  112.114, we proposed to 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 adequately reduce the presence of 
microorganisms of public health significance). We also proposed to 
clarify in this provision that dropped covered produce does not include 
root crops (such as carrots) that grow underground or crops (such as 
cantaloupe) that grow on the ground. We also noted 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 are finalizing this section with certain changes as 
described in the paragraphs that follow.
    (Comment 336) Several comments favor the requirements of this 
provision, as proposed. However, one comment expresses a view that this 
requirement

[[Page 74488]]

should be applied by a farm according to an operational assessment of 
risk specific to that farm.
    (Response) We refer you to the discussion in section VII of this 
document, where we explain our conclusion not to require covered farms 
to conduct operational assessments or develop farm-specific food safety 
plans, although we encourage farms to do so voluntarily to identify any 
specific risks and operational efficiencies appropriate for their 
circumstances. We recognize the importance of tailoring your food 
safety practices to the commodities, practices, and conditions 
applicable to your individual operation. Covered farms may take steps 
to ensure the safety of their dropped covered produce as determined by 
a farm-specific operational assessment, as long as those steps are 
consistent with and do not violate the requirements of this rule, 
including Sec.  112.114.
    (Comment 337) Several comments express that certain produce 
commodities are intentionally dropped on the ground as part of their 
regular harvesting practice. For example, some comments refer to the 
harvesting practices of the tree nut industry in which some types of 
tree nuts (e.g. hazelnuts, chestnuts, and almonds) are typically shaken 
from the trees onto the ground as part of harvesting, and agree with 
our proposal that tree nuts and other commodities that are 
intentionally dropped as a part of harvesting should not be covered 
under this provision. Other comments request that FDA exclude from this 
provision any commodity that has an outer covering (such as a rind or 
husk) that is not typically consumed. Some comments generally question 
the scientific basis supporting this requirement. These commenters 
argue that there is no certainty that pathogens transfer into produce 
after contact with the ground, and assert that the likelihood of 
pathogens being at the exact spot where the produce drops is remote.
    (Response) In the 2013 proposed rule, we acknowledged that some 
produce is intentionally dropped to the ground as a part of the 
harvesting practice (e.g., some tree nuts), and that we expect that 
such harvesting practices were developed because the fall does not 
damage the edible crop, which is protected by a durable shell. 
Accordingly, we proposed to define ``dropped covered produce'' within 
Sec.  112.114 in a manner that excludes produce that is intentionally 
dropped as part of harvesting (i.e., produce that drops to the ground 
before harvest). Taking this into account and in light of other 
comments (see our response to Comment 338) we are revising Sec.  
112.114 to explicitly state that dropped covered produce does not 
include produce that is intentionally dropped as part of the harvesting 
method (for example, when trees bearing tree nuts, such as almonds, are 
intentionally shaken to drop tree nuts to the ground to be harvested). 
We note that this rule, including Sec.  112.114, is not applicable to 
produce commodities that are identified in 112.2(a)(1) as rarely 
consumed raw, such as hazelnuts.
    However, we have concluded that we should not similarly exclude all 
produce that has an outer peel that is inedible or not typically 
consumed. 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. 192). In 
addition, risk assessment models for apple contamination (Ref. 193) 
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. 193). Moreover, fruits with outer 
layers that are inedible or typically not consumed have been implicated 
in illness outbreaks. In 2011-2012, outbreak events have been linked to 
whole, intact mangoes, papayas, and cantaloupes (Ref. 194) (Ref. 195) 
(Ref. 196). Although these outbreak investigations did not conclude 
that contamination was a result of dropped produce that was harvested 
and sold, each of these fruits has an outer covering that is either 
inedible or typically not consumed. Moreover, as discussed in our QAR, 
there are limited data on the effect of peeling (and cutting) on the 
levels of pathogens across the range of commodities. Some produce 
commodities have an inedible rind that is generally removed in such a 
way that minimizes the potential for any surface contamination to come 
in contact with the edible portion of the fruit. In such commodities, 
for example bananas and coconuts, peeling before consumption may 
significantly reduce the potential for contamination. However, other 
produce commodities (e.g., mangos, oranges, carrots) are usually peeled 
in such a way (e.g., using a knife) that contamination on the surface 
can be carried to the edible portion of the produce. Thus, FDA 
maintains that provision Sec.  112.114 should apply generally to 
covered produce with only the exclusions specified in the provision, 
irrespective of whether such produce also has an inedible or rarely 
consumed outer layer. This conclusion is based on the likelihood of 
damage to the outer layer allowing access to the interior of the 
commodity, increased rates of contamination observed on some types of 
dropped produce, and the uncertainty that having some kind of inedible 
or rarely consumed outer layer provides sufficient protection to 
counteract these concerns as a general matter.
    (Comment 338) Several comments note that proposed Sec.  112.114, as 
worded, suggests that covered produce that is unintentionally dropped 
to the ground during harvest would be acceptable for distribution. One 
comment recommends revising this provision to clarify that covered 
farms must not distribute covered produce that falls to the ground 
``before and during harvest.'' Another comment states that dropped 
produce should not include produce that is still attached to the plant 
at the time of harvest.
    (Response) Covered produce is subject to the requirements in Sec.  
112.114 unless it is specifically identified as not being included 
within the meaning of ``dropped covered produce.'' Under revised Sec.  
112.114, dropped covered produce does not include root crops (such as 
carrots) that grow underground, crops (such as cantaloupe) that grow on 
the ground, or produce that is intentionally dropped to the ground as 
part of the harvesting method (such as almonds). However, produce that 
grows off the ground, such as tomatoes and apples, and that drop to the 
ground before harvest is considered dropped covered produce, even if 
articles of produce are still attached to the plant when they contact 
the ground. Moreover, an article of covered produce that drops to the 
ground before that specific article can be harvested, regardless of 
whether the farm has started harvesting generally, is still dropped 
covered produce subject to Sec.  112.114 unless it is otherwise 
excluded (e.g., if dropping is an intentional part of the harvesting 
process). For example, when an apple drops to the ground before it is 
harvested, it is dropped covered produce, whether or not the covered 
farm has already begun harvesting apples from that orchard such that 
the farm might consider the apple to have unintentionally fallen 
``during'' its harvesting of the orchard. The apple in this example 
dropped before the apple was harvested.
    (Comment 339) One commenter requests that FDA clarify that dropped 
covered produce may be used for personal consumption, for commercial 
processing, or for food for animals.

[[Page 74489]]

    (Response) We are removing the reference to produce that is exempt 
under Sec.  112.2(b) from the codified text of this section. We are 
making this change because produce that is exempt from the requirements 
of part 112 under Sec.  112.2(b) is exempt from all the requirements in 
part 112 except those specified in Sec.  112.2(b). We are concerned 
that including a specific reference to exempt produce in Sec.  112.114 
might have misleadingly and incorrectly suggested that produce that is 
not covered by part 112 (under Sec.  112.2(a), because it is rarely 
consumed raw, produced by an individual for personal consumption or 
produced for consumption on the farm or another farm under the same 
management, or not a RAC), or produce that is exempt from part 112 
(under Sec.  112.2(b), because it receives commercial processing that 
adequately reduces the presence of microorganisms of public health 
significance), is subject to certain requirements other than as 
specified in Sec.  112.2. In fact, neither produce that is not covered 
by part 112 (under Sec.  112.2(a)), or produce that is exempt from part 
112 (under Sec.  112.2(b)) is subject to Sec.  112.114.

E. Packaging Covered Produce (Sec.  112.115)

    (Comment 340) Several comments generally support this provision. 
One such comment finds no reason to highlight mushrooms as an example, 
and requests removing it from the text of the codified provision. This 
commenter states that there have been significant updates to packaging 
practices since the research FDA cited, which was conducted in 1978. In 
addition, this commenter believes that packaging mushrooms is likely 
done in a packinghouse that would be subject to the PCHF regulation, 
rather than to the produce safety regulation. Furthermore, some 
commenters express a view that it is important to consider whether 
Clostridium botulinum (C. botulinum) is a potential hazard for any 
commodity, just as it is important to consider all pathogens, and not 
just anaerobic bacteria, to ensure appropriate packaging.
    (Response) The provision in Sec.  112.115 requires you to package 
covered produce in a manner that prevents the formation of C. botulinum 
toxin, if such toxin is a known or reasonably foreseeable hazard. This 
requirement applies to the packaging of any covered produce where the 
formation of C. botulinum toxin is a known or reasonably foreseeable 
hazard. Within this provision, we explicitly list mushrooms as an 
example because the formation of C. botulinum toxin in mushrooms, when 
packaged under certain conditions, is a known or reasonably foreseeable 
hazard. As discussed in the 2013 proposed rule, the potential for toxin 
production by C. botulinum in mushrooms packaged under reduced oxygen 
conditions is well-established (Ref. 197). Mushrooms grow close to the 
ground, which is a source of C. botulinum spores, and 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. 
198). In such reduced oxygen or anoxic conditions, C. botulinum spores 
can germinate and multiply resulting in the formation of botulinum 
toxin, which can occur before any overt signs of mushroom spoilage 
(Ref. 197). Therefore, we continue to believe that mushrooms are an 
appropriate example.
    Modified atmosphere or other reduced-oxygen packaging of produce 
other than mushrooms may present a similar risk for botulinum toxin 
formation (Ref. 199). Therefore, it would be incorrect to infer that 
packaging of mushrooms is the only circumstance where C. botulinum 
toxin formation is a known or reasonably foreseeable hazard. We 
continue to include mushrooms as an example, but they are only an 
example.
    Moreover, covered farms must ensure their food packing (including 
food packaging) material is adequate for its intended use, as required 
in Sec.  112.116 (discussed in the paragraphs that follow). Section 
112.116 relates to all pathogens, and is not limited to C. botulinum 
toxin. Section 112.115 goes beyond the packing material requirements in 
Sec.  112.116 and applies specifically to the hazard of formation of C. 
botulinum toxin. Whereas Sec.  112.116 is aimed at ensuring that 
packing materials themselves do not introduce hazards into produce, 
Sec.  112.115 is aimed at the specific hazard of C. botulinum toxin 
when produce is packaged in a manner that allows C. botulinum spores to 
germinate and multiply, resulting in the formation of botulinum toxin, 
which can occur before any overt signs of spoilage of the produce. A 
farm using reduced oxygen packaging might comply with this requirement 
by applying means to reduce the potential for toxin formation. For 
example, perforated packaging film allows free air access and is a 
means to reduce the potential for toxin formation in mushrooms (Ref. 
200) (Ref. 201). Other means of preventing toxin formation in 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. 
199). Scientific information should support the use of methods used to 
prevent toxin formation, such as use of perforated packaging film, 
time-temperature integrators and antimicrobial compounds.
    We also note that, even if some packing or packaging of mushrooms 
may be done in facilities subject to the PCHF regulation, it is also 
likely that covered farms will conduct relevant activities within the 
coverage of the produce safety regulation. The definition of ``farm'' 
as provided in both this regulation (in Sec.  112.3(c)) and the PCHF 
regulation includes packing of RACs, and packaging of RACs when such 
packaging does not include additional manufacturing/processing. An 
example of additional manufacturing/processing is irradiation. However, 
Sec.  112.115 applies to packaging that does not include additional 
manufacturing/processing; such packaging includes modified atmosphere 
packaging and other methods of packaging of covered produce in a manner 
that creates anaerobic conditions where the formation of C. botulinum 
toxin is a known or reasonably foreseeable hazard. For example, 
packaging of mushrooms or other covered produce in semipermeable 
plastic films is a covered activity that fits within the farm 
definition and is, therefore, subject to this rule and to Sec.  
112.115.
    Accordingly, we are finalizing Sec.  112.115, as proposed, with no 
changes.

F. Food-Packing (Including Food Packaging) Material (Sec.  112.116)

    (Comment 341) Several comments agree that food-packing and 
packaging material must be adequate for its intended use. One comment 
requests clarification of what is meant by ``adequate for its intended 
use,'' and suggests incorporating the following text from the preamble 
of the 2013 proposed rule into the codified provision: ``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.''
    (Response) In the 2013 proposed rule, we provided some examples of 
what food-packing material would be adequate for its intended use in 
compliance with Sec.  112.116(a). For

[[Page 74490]]

example, food packing material that is adequate for its intended use 
includes plastic bins for holding fresh-picked fruit, wax impregnated 
corrugated cardboard for broccoli to be hydro-cooled 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 are used during harvest also must 
meet the requirement in Sec.  112.116(a), and can be used if they are 
adequately clean and sanitary for their intended use. This section 
requires that you use food-packing materials that are adequate for 
their intended use, which includes being: (1) Cleanable or designed for 
single use and (2) unlikely to support growth or transfer of bacteria. 
We are revising Sec.  112.116(a) to include this additional 
information.
    (Comment 342) Several comments discuss the use of containers (or 
bags or sacks) made from wooden, plastic, or cloth-like materials and 
pulp materials, as well as decorative containers used to enhance retail 
presentation. Many of these comments discuss the variety of on-farm and 
off-farm uses of such containers, and request that we allow the 
continued use of wooden containers and other porous materials during 
harvesting. Several other commenters point out requiring farms to 
switch to plastic containers would cause significant economic burden 
and may also result in loss of crop due to reduced air flow observed 
with plastic packing materials.
    (Response) The only restriction we are establishing on the types of 
food packing materials you may use for covered produce is that such 
materials must be adequate for their intended use (Sec.  112.116(a)). 
As discussed in response to Comment 341, this includes being (1) 
cleanable or designed for single use and (2) unlikely to support growth 
or transfer of bacteria. Thus, you may re-use food-packing material 
provided that it is cleanable and it is unlikely to support growth or 
transfer of bacteria. Moreover, if you re-use food packing material, 
you must take steps to ensure that food-contact surfaces are clean; for 
example, you must clean the food packing containers or use a clean 
liner on the food packing container to protect produce from 
contamination (Sec.  112.116(b)). The necessary frequency of such 
cleaning, and the necessary frequency with which liners must be 
replaced, will likely vary depending on the circumstances. Therefore we 
are not specifying a single required cleaning frequency in this 
regulation. However, we are revising this section to make clear that 
the steps you take, including the frequency of cleaning or replacing 
liners, must be adequate.
    We are not requiring farms that use wooden or other porous food 
packing materials to stop using them, but we are requiring that such 
materials be used only to the extent they are cleanable and unlikely to 
support the growth or transfer of bacteria. As noted in the 2013 
proposed rule, although some food-packing materials are sufficiently 
sturdy to be used multiple times, such materials may serve as a source 
of contamination if they are not adequately clean and/or if the 
material is used beyond its shelf life and adequate cleaning cannot be 
achieved.
    (Comment 343) One comment generally supports requiring that food-
contact surfaces of reusable food packing material be cleaned and 
sanitized between uses. In contrast, a few comments object to provision 
Sec.  112.116(b) to the extent it may require sanitizing food 
containers. One such comment states that it is not feasible for farmers 
to sanitize all harvest containers, and another comment notes some 
current practices involve using wooden bins, carpet-cushioned or 
cardboard-cushioned trailers and transporters, and other materials that 
cannot be sanitized. Yet another comment states that wooden bins used 
on farms during harvesting should be required to be kept clean, but not 
required to be sanitized.
    (Response) We are not requiring you to sanitize all food packing 
containers or food-contact surfaces that you re-use during harvesting, 
packing, or holding of covered produce. Rather, per Sec.  112.116(a), 
you must use food-packing material that is adequate for its intended 
use and, per Sec.  112.116(b), if you re-use a food packing container, 
you must take measures to ensure that the food-contact surfaces of that 
container are clean. We recognize the use of ``sanitizing'' in the 
example we provided within proposed Sec.  112.116(b) (i.e., ``such as 
by cleaning and sanitizing, when necessary, food-packing containers'') 
is confusing and implies a requirement that goes beyond that described 
in the established measure (i.e., ``if you reuse food-packing material, 
you must take steps to ensure that food-contact surfaces are clean''). 
Therefore, we are revising Sec.  112.116(b) by removing the reference 
to ``sanitizing'' such that the provision reads as follows: ``if you 
reuse food-packing material, you must take adequate steps to ensure 
that food-contact surfaces are clean, such as by cleaning food-packing 
containers or using a clean liner.''
    However, under Sec.  112.111(b), you are required to 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. For example, if you use food 
packing containers that were previously used to pack or hold excluded 
produce, and the excluded produce is not grown, harvested, packed, or 
held in accordance with part 112, you must clean and sanitize, as 
necessary, the food-contact surfaces of the containers that came into 
contact with the excluded produce before subsequently using the same 
containers for packing covered produce. In summary, taking adequate 
steps to ensure that food-contact surfaces of food-packing materials 
are clean is required whenever you are re-using food packing material 
for covered produce, and sanitizing such surfaces is also required, as 
necessary, when re-using such materials after using them on excluded 
produce not handled in accordance with part 112.

XVII. Subpart L--Comments on Equipment, Tools, Buildings, and 
Sanitation

    In subpart L of proposed part 112, we proposed to establish 
science-based minimum standards that are reasonably necessary to 
prevent 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. We asked for comment on the proposed provisions of 
this subpart.
    We are finalizing these provisions with revisions (see Table 23). 
We discuss these changes in this section.

             Table 23--Description of Revisions to Subpart L
------------------------------------------------------------------------
       Final provision                  Description of revisions
------------------------------------------------------------------------
Sec.   112.121...............  --Revisions to delete the term ``other
                                contamination'', and replace
                                ``undesirable microorganisms'' with
                                ``microorganisms of public health
                                significance''.

[[Page 74491]]

 
Sec.   112.123(d)............  --Revision to move ``when necessary and
                                appropriate'' before ``sanitize'' to
                                clarify applicability.
Sec.   112.124...............  --Revisions to delete the term ``other
                                contamination'', and replace
                                ``undesirable microorganisms'' with
                                ``microorganisms of public health
                                significance''.
Sec.   112.126...............  --Revision to eliminate proposed Sec.
                                112.126(a)(3) and, instead, establish
                                new provision Sec.   112.126(b)
                                requiring measures to prevent
                                contamination of covered produce and
                                food contact surfaces in buildings, as
                                appropriate, considering the potential
                                for contamination through floors, walls,
                                ceilings, fixtures, ducts, or pipes, and
                                drip or condensate.
Sec.   112.129...............  --Revision to clarify the required
                                frequency of servicing and cleaning
                                toilet facilities.
Sec.   112.130...............  --Revision to amend the list of examples
                                of adequate drying devices (removing
                                clean cloth towels and adding electric
                                hand dryers).
                               --Revision to use the term ``antiseptic
                                hand rubs'' in lieu of ``hand antiseptic/
                                sanitizer or wipes''.
                               --Revision to permit the use of ``other
                                effective surfactants'' in lieu of soap.
Sec.   112.140...............  --No change.
------------------------------------------------------------------------

    We are finalizing the other provisions of subpart L as proposed. 
For Sec. Sec.  112.127, 112.128, 112.131, 112.132, 112.133, and 
112.140, we did not receive any comments or received only general 
comments in support of the proposed provision and, therefore, we do not 
specifically discuss these provisions.

A. Types of Buildings That Are Subject to the Requirements of Subpart L 
(Sec.  112.122)

    (Comment 344) Some comments express concern with the applicability 
of the proposed provisions in subpart L to greenhouses (including high 
tunnels), germination chambers, or other protected environment 
production areas. A comment states that applying the proposed building 
requirements to greenhouses would negatively impact small farmers in 
areas without a warm climate for most of the year, such as in the North 
east, where farmers rely on greenhouses to grow produce throughout the 
year. Other comments contend that protected environment production 
areas enable farms to control various aspects of growing, such as 
humidity, temperature, or light, and believe it is highly improbable 
that a pathogen of public health significance would find its way into 
the controlled system.
    (Response) The provisions in subpart L apply to any fully or 
partially-enclosed buildings used for covered activities, including 
greenhouses, germination chambers, or other such structures. These 
structures used for growing activities can create an enclosed system 
where potential hazards can be amplified (Ref. 202). Therefore, we do 
not agree that greenhouses, high tunnels, germination chambers, or 
``protected environment production areas'' should be generally exempt 
from the standards in subpart L.
    We do not discourage the practice of growing produce inside 
greenhouses, germination chambers, or other such structures nor do we 
intend our requirements in subpart L to specifically impact small farms 
that use such structures for growing produce. Rather, our concern is to 
establish those procedures, processes, and practices that are 
reasonably necessary to prevent the introduction of 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. In response to 
these and other comments, we reviewed the provisions in subpart L to 
determine their appropriateness and practicability when applied to 
greenhouses (including high tunnels), germination chambers, and other 
such structures used for growing covered produce. We are deleting one 
provision in subpart L (i.e., Sec.  112.126(a)(3)) and replacing it 
with a new provision we believe is more appropriate to apply to all 
covered farm buildings, including greenhouses, germination chambers, 
and other such structures (see Comment 352).
    (Comment 345) Some comments state many existing on-farm structures 
will likely not meet the proposed building requirements, and one 
comment additionally states there are no data available on the number 
or quality of on-farm buildings such as packing sheds and storage 
facilities.
    (Response) We used available data sources to inform proposed 
provisions and our estimates of economic burden associated with the 
provisions in subpart L (Ref. 142). Under Sec.  112.122(b), storage 
sheds, buildings, or other structures used to store food-contact 
surfaces (such as harvest containers and food-packing materials) are 
subject to the requirements of subpart L. We believe it is important to 
apply the science-based minimum standards in subpart L to such 
buildings because contaminated food-contact surfaces can contaminate 
covered produce (Ref. 203) and, thus, present a potential hazard.

B. Equipment and Tools (Sec.  112.123)

    (Comment 346) Some comments recommend covered farms be allowed to 
clean equipment and tools as an alternative to the requirement related 
to storage and maintenance of equipment and tools in proposed Sec.  
112.123(b)(2).
    (Response) We are establishing the requirement in Sec.  
112.123(b)(2) because appropriate practices for storing and maintaining 
equipment and tools can protect against contamination and reduce the 
potential for attracting or harboring pests, which can carry human 
pathogens. Pest harborage by equipment not only can contaminate the 
equipment; it can also increase the prevalence of pests near a 
building, and provide a place for them to live and breed. We have 
included sufficient flexibility in this requirement such that you may 
store equipment and tools in a manner that is practical but also 
protects against contamination and prevents attraction and harborage of 
pests. For example, you may satisfy this requirement by storing 
equipment indoors or outdoors, provided that the location appropriately 
protects against contamination and you appropriately minimize 
surrounding debris, check periodically for pests, and take any other 
measures reasonably necessary under the circumstances. Separate and 
distinct from this requirement regarding storage and maintenance is the 
provision in Sec.  112.123(d)(1), which requires you to inspect, 
maintain, and clean and sanitize (when necessary and appropriate) all 
food-contact surfaces of equipment and tools used in covered 
activities. This provision is intended to prevent transfer of 
contaminants on food-contact surfaces of equipment or tools to covered 
produce. Appropriate storage, maintenance, and cleaning of equipment 
are all reasonably necessary to minimize the risk of produce

[[Page 74492]]

contamination, and we disagree that cleaning of equipment and tools 
alone should relieve a covered farm of the need for proper storage and 
maintenance of equipment and tools.
    (Comment 347) Two comments question the applicability and 
practicality of the requirement to ``sanitize'' food-contact surfaces 
of equipment and tools under Sec.  112.123(d)(1) with respect to the 
knife that cuts the asparagus below the ground if the part of the spear 
that the knife contacts is cut off before the spear is shipped to 
consumers. One comment acknowledges that asparagus was not covered 
under the 2013 proposed rule, and asks us to clarify what would be 
required with respect to sanitation of ``asparagus boxes'' containers, 
if asparagus were to be covered by the final rule.
    (Response) We are establishing the requirement in Sec.  
112.123(d)(1) taking into account evidence that pathogens can be 
transferred to produce from contaminated coring devices and 
contaminated food-contact surfaces of tools (Ref. 204) (Ref. 205). We 
acknowledge that sanitizing all food-contact surfaces of equipment and 
tools used in covered activities is impractical, considering the wide 
range of equipment and tools used in covered activities and the 
diversity of produce growing, harvesting, packing, and holding 
practices. Therefore, in Sec.  112.123(d)(1), we are requiring you to 
sanitize only when necessary and appropriate, but to always inspect, 
maintain, and clean all food-contact surfaces of equipment and tools 
used in covered activities, and to do so as frequently as reasonably 
necessary to protect against contamination of covered produce. As the 
commenter noted, asparagus is not covered under this rule because it is 
rarely consumed raw (see Sec.  112.2(a)(1)).
    (Comment 348) With respect to proposed Sec.  112.123(d)(2) related 
to non-food-contact surfaces, some comments point out that non-food-
contact surfaces (such as on trailers, tractors, and vehicles) are, by 
definition, not expected to come into contact with produce and, as 
such, are rarely designed to be cleaned to the same degree of 
cleanliness as food-contact surfaces. These comments request us either 
to provide clarification on how operations would be expected to 
implement this requirement or to delete this requirement.
    (Response) As discussed in the 2013 proposed rule, the potential 
for equipment or a 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 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, we acknowledge that such surfaces may not require 
cleaning as frequently as those that come into direct contact with 
produce, and also may not require sanitizing. Under this provision, you 
are required to maintain and clean all non-food-contact surfaces of 
equipment and tools used in covered activities during harvesting, 
packing, and holding as frequently as reasonably necessary to protect 
against contamination of covered produce. We provide examples of 
equipment and tools subject to the requirements of subpart L in Sec.  
112.121.
    In contrast to the requirements regarding food-contact surfaces in 
Sec.  112.123(d)(1), the requirements related to non-food-contact 
surfaces in Sec.  112.123(d)(2) do not require sanitizing such 
surfaces. As an example, the blades and conveyors in a harvesting 
machine that directly contact produce are considered a food-contact 
surface, but the portion of the truck that is used to hold boxes or 
crates containing harvested produce is not a food-contact surface. 
Likewise, the brush rollers on a sorting or grading machine where the 
rollers come in direct contact with the produce are food-contact 
surfaces, and must be inspected, maintained, and cleaned and, as 
necessary and appropriate, sanitized per Sec.  112.123(d)(1). In 
contrast, a gear box attached to the rollers that does not come into 
contact with produce is a non-food-contact surface, and must be 
maintained and cleaned per Sec.  112.123(d)(2).

C. Instruments and Controls Used To Measure, Regulate, or Record (Sec.  
112.124)

    (Comment 349) One comment generally supports proposed Sec.  
112.124. Another comment requests clarification regarding what is meant 
or intended by ``other contamination''.
    (Response) We are revising Sec. Sec.  112.121 and 112.124 to delete 
the term ``other contamination'' and to replace ``undesirable 
microorganisms'' with ``microorganisms of public health significance.'' 
The requirements in this rule are intended to address microorganisms of 
public health concern and not all forms of contamination or undesirable 
microorganisms generally.

D. Equipment Used in the Transport of Covered Produce (Sec.  112.125)

    (Comment 350) Some comments express concern that requiring cleaning 
of surfaces that come into contact with covered produce during their 
transport would be problematic for the watermelon industry. Comments 
state that harvest transportation from field to packing shed for 
watermelons is often done by using buses that are adapted for this 
purpose by, for example, covering the interior of the bus at the 
beginning of the season with either carpet or cardboard to cushion and 
protect the watermelons from damage and pathogen contamination from 
bruises or cuts that could occur during transport.
    (Response) Section 112.125 is not prescriptive about the manner in 
which farms ensure that their equipment used to transport covered 
produce is adequately cleaned before use in transporting covered 
produce and is adequate for use in transporting covered produce. This 
provision requires covered farms to take measures to minimize the risk 
that equipment used during transportation becomes a potential source of 
contamination of covered produce. In the specific instance described in 
these comments, we expect the cushioning material(s) that comes into 
contact with the watermelons to be adequately cleaned prior to 
transportation and to be adequate for its intended use (meaning it must 
be cleanable or designed for single use, and unlikely to support growth 
or transfer of bacteria).

E. Buildings (Sec.  112.126)

    (Comment 351) One comment states that, under proposed Sec.  
112.126, a cooler in a packing house would be required to have 18'' of 
separation from the wall around the entire perimeter on the inside of 
the cooler, such that a 10,000 sq. ft. cooler might lose 5 percent of 
its floor space. This comment also notes that such a requirement would 
discriminate against smaller operations, and also create an unsafe 
working environment due to ``free standing'' stacks of bins.
    (Response) Under Sec.  112.126(a)(1)(i), buildings must provide 
sufficient space for placement of equipment and storage of materials. 
We are not establishing a precise amount of space needed for the 
placement or storage of materials, or a minimum distance required 
between an interior wall and any stacked bins or pallets. The intent of 
this provision is to ensure that buildings are spacious enough for the 
maintenance of sanitary operations and the conduct of covered 
activities. In the specific circumstance

[[Page 74493]]

described by the commenter, space between the bins or pallets and the 
interior wall is not necessary if the bins or pallets can be moved to 
allow for cleaning activities.
    (Comment 352) Some comments express concern regarding proposed 
Sec.  112.126(a)(3) requiring that buildings must be constructed in a 
manner such that drip or condensate does not contaminate covered 
produce, food-contact surfaces, or packing materials. Comments note, by 
nature of the indoor growing process or cold-storage process, it would 
be impossible to prevent formation of condensate. Comments also note 
condensate sometimes is present in a produce growing room but that 
because growing rooms are cleaned and sanitized between each crop, the 
condensation does not come from an unsanitary surface and, therefore, 
poses no threat of contamination. Comments object to this proposed 
requirement particularly with respect to its applicability to certain 
types of buildings, such as greenhouses (including high tunnels) and 
cold storage buildings. Comments recommend excluding greenhouses 
(including high tunnels and low tunnels) and other season-extending, 
non-permanent structures used for growing, as well as cold storage 
buildings from coverage under proposed Sec.  112.126(a)(3) and/or 
creating alternative standards, recognizing that condensation cannot be 
prevented in such buildings.
    (Response) Proposed Sec.  112.126(a)(3) would have applied equally 
to fully-enclosed structures used in growing activities as it would to 
storage sheds, packing sheds, barns, or other farm buildings used for 
packing or holding activities, and would have required that buildings 
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. Upon 
review of these comments, we agree there is a need to incorporate 
flexibility in the implementation of this provision to account for 
differences inherent to certain covered activities conducted in fully- 
or partially-enclosed buildings. For example, condensation is a common 
occurrence in fully-enclosed buildings used for growing activities 
(such as greenhouses, including high tunnels, which are substituting 
for growing conditions in an open field), and may not represent a 
likely source of contamination of covered produce if produce is 
physically protected from condensate drip or the interior of the fully-
enclosed building (such as walls and ceiling) where condensate is 
formed (and may drip onto covered produce) is kept adequately clean. 
Similarly, condensation is a natural phenomenon during storage under 
high relative humidity conditions and if produce is physically 
protected from condensate drip or the interior of such cold-storage 
building is adequately clean, any condensate that forms on walls or 
ceiling is not likely to be a potential source of contamination. We are 
making revisions to the codified text so that a covered farm is 
required to take measures necessary to protect covered produce and 
food-contact surfaces from potential contamination from building 
surfaces such as floors, walls, ceilings, fixtures, ducts, or pipes, 
and generally through condensation or drip from these or other 
surfaces, rather than requiring farms to prevent condensation or drip 
contact with covered produce or food-contact surfaces.
    We are deleting proposed Sec.  112.126(a)(3) and replacing it with 
a new provision under Sec.  112.126(b), which requires that covered 
farms implement measures to prevent contamination of covered produce 
and food-contact surfaces in the farm's buildings, as appropriate, 
considering the potential for such contamination through: (1) Floors, 
walls, ceilings, fixtures, ducts, or pipes; and (2) drip or condensate. 
For example, to comply with this provision, you must consider whether 
for your growing or storage practices in your buildings, the occurrence 
of drip or condensate presents a potential for contamination of your 
covered produce, and take measures to minimize or prevent that 
potential for contamination. Such measures include, for example, 
keeping buildings in good repair so as to prevent leakage of rainwater 
into the walls or ceilings of buildings, so that any drip or condensate 
from overhead pipes or ceilings that may drop onto covered produce or 
food-contact surfaces does not contaminate covered produce. Such 
measures also include adequately and regularly cleaning fixtures, 
ducts, or pipes inside the building where covered activities occur in 
order to minimize the presence or persistence of hazards, such as in 
biofilms, and the potential for contamination of covered produce.
    (Comment 353) With respect to the requirement in proposed Sec.  
112.126(a)(3) that buildings must be constructed in a manner such that 
floors, walls, ceilings, fixtures, ducts, and pipes can be adequately 
cleaned and kept in good repair, one comment suggests that this 
requirement may preclude use of certain older barns, and further 
asserts that ``modern'' warehouses have been associated with foodborne 
illnesses.
    (Response) It is not our intent to preclude the use of any specific 
types of buildings or barns; rather, we are establishing the provisions 
in subpart L to ensure that buildings used in covered activities are 
suitable and facilitate sanitary operations, and can be adequately 
cleaned and maintained to prevent contamination of the covered produce, 
food-contact surfaces, or packing materials. We are deleting Sec.  
112.126(a)(3) and replacing it with a new provision under Sec.  
112.126(b) that we believe is more appropriate to apply to all covered 
farm buildings (see our response to Comment 352). We have no data or 
information to suggest that large warehouse-like structures pose a 
greater risk of produce contamination compared to smaller barn-like 
structures, and the commenter provided no data to support this claim.
    (Comment 354) One comment expresses concern that proposed Sec.  
112.126(a)(3) would require farms to prevent the pooling of water on 
the floor and lay out the crops in a manner that workers may move 
freely without their clothes touching the produce.
    (Response) We are deleting proposed Sec.  112.126(a)(3) and 
replacing it with a new provision under Sec.  112.126(b); see Comment 
352. Under Sec.  112.126(a)(2), 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. We acknowledge the 
potential for small pools of water to temporarily form on the floor of 
buildings used for growing activities, and that pooling of water of 
this nature, which is temporary and may occur in the normal course of 
watering practices, is 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 greenhouse watering practices with consideration to your 
drainage system is ideal; however, to the extent pooling may be 
inevitable or may sometimes occur, despite adequate drainage, we expect 
covered farms to take steps to protect covered produce from any 
contamination that may build in the pooled water. Moreover, Sec.  
112.126(a), which addresses building design and construction 
requirements, does not impose any specifications regarding crop layout 
in buildings used for growing activities or establish measures for 
movement of workers within covered areas in a building. Rather, a 
covered farm is required to implement measures related to worker health 
and hygiene in accordance with subpart D of part 112.

[[Page 74494]]

F. Toilet Facilities (Sec.  112.129) and Hand-Washing Facilities (Sec.  
112.130)

    (Comment 355) A few comments note that it is not necessary for 
toilet facilities to be cleaned ``on a schedule'', and request that 
Sec.  112.129(b)(2) be revised to remove the reference to a schedule 
and require instead that they must be ``serviced and cleaned at a 
frequency sufficient to ensure suitability of use.''
    (Response) We intend for this requirement to provide flexibility 
for covered farms to determine the frequency of servicing necessary to 
keep the toilet facilities clean and suitable for use. We are revising 
this provision, as suggested by commenters, to make our intent more 
clear.
    (Comment 356) One comment recommends that the requirements 
applicable to toilet facilities (in Sec.  112.129) and hand-washing 
facilities (in Sec.  112.130) should either simply reference OSHA field 
sanitation standards in 29 CFR 1928.110 or mirror those standards as 
closely as possible to avoid confusion and conflicting requirements.
    (Response) The requirements for toilet and hand-washing facilities 
in Sec. Sec.  112.129 and 112.130 are generally similar and consistent 
with the requirements in the United States Occupational Safety and 
Health Administration's (OSHA) field sanitation standards in 29 CFR 
1928.110, although the OSHA standards are more prescriptive in some 
provisions. For example, whereas we are establishing a general 
requirement that you must provide personnel with adequate, readily 
accessible toilet facilities, including facilities readily accessible 
to growing areas during harvesting activities (Sec.  112.129(a)), the 
OSHA standards include specific requirements on the number and 
proximity of such facilities. The field sanitation standards in 29 CFR 
1928.110 specify that one toilet facility and one hand-washing facility 
must be provided for each twenty employees or fraction thereof (with 
additional exception) (paragraph (c)(2)(i)), and that the toilet and 
hand-washing facilities shall be located within a one-quarter-mile walk 
of each hand laborer's place of work in the field (paragraph 
(c)(2)(iii)).
    Nevertheless, we disagree that the toilet and hand-washing 
provisions in part 112 should simply refer to the field sanitation 
standards in 29 CFR 1928.110. Unlike the OSHA field sanitation 
standards, the requirements in Sec. Sec.  112.129 and 112.130 relate 
specifically to the growing, harvesting, packing, and holding of 
covered produce, with a focus on minimizing the risk of contamination 
of covered produce, food-contact surfaces, or areas used for a covered 
activity with human waste or by ill or infected workers. Moreover, the 
OSHA field sanitation standards apply only to an agricultural 
establishment where 11 or more employees are engaged on any given day 
in hand-labor operations in the field. (As defined in paragraph (b) of 
that regulation, hand-labor operations exclude those conducted in 
permanent structures such as in packing houses). It is not clear that 
this scope, established for the purposes of the OSHA field sanitation 
standards, sufficiently addresses the covered farms and covered 
activities defined in this rule for the purposes of produce safety 
standards. Therefore, we decline the request to simply refer to 29 CFR 
1928.110 in lieu of establishing requirements for toilet and hand-
washing facilities in part 112. Compliance with our provisions for 
toilet and hand-washing provisions in part 112 do not preclude 
compliance with OSHA field sanitation requirements, and we believe our 
requirements in part 112 can be met concurrently with those of OSHA 
field sanitation.
    (Comment 357) According to one comment, hand-washing stations are 
typically located together with field toilets and, in the case of open 
fields, it would not be possible or realistic to have a hand-washing 
station located in a fully-enclosed building.
    (Response) We are not requiring hand-washing stations to be located 
inside a fully-enclosed building. Rather, under Sec.  112.129(c), 
during growing activities that take place in a fully-enclosed building, 
and during covered harvesting, packing, or holding activities, you are 
required to provide a hand-washing station that is in sufficiently 
close proximity to toilet facilities, such that it is practical for 
persons who use the toilet facility to wash their hands.
    (Comment 358) One comment generally notes that employers must 
provide agricultural workers with necessary training, protective 
equipment, and hygienic supplies (such as enough clean bathrooms and 
hand-washing facilities) while working on the farm.
    (Response) We agree that employers must provide agricultural 
workers with necessary training, and hygienic supplies while working on 
the farm. In this subpart L, we are finalizing provisions Sec. Sec.  
112.129 and 112.130 to establish requirements for toilet and hand-
washing facilities, and in subpart C of this rule, we are establishing 
requirements related to worker training.
    (Comment 359) With respect to the provision related to hand-drying 
devices in proposed Sec.  112.130(b)(3), one comment recommends that 
the use of ``clean cloth towels'' be limited to operations where only 
one person would be using the ``clean cloth towel'' to dry their hands. 
This comment notes that use of a ``clean cloth towel'' to dry multiple 
persons' hands should not be allowed as this is likely to facilitate 
the transference of pathogens (if present) from one towel user to the 
next. An additional comment notes that the example of ``clean cloth 
towels'' listed as an adequate drying device conflicts with OSHA's 
requirement of single-use towels. Finally, another comment requests 
that we provide for use of electric hand dryers because the quality of 
drying from these devices can be similar to paper towels.
    (Response) Under OSHA's field sanitation standards, a ``hand-
washing facility'' means a facility providing a basin, container, or 
outlet with an adequate supply of potable water, soap and single-use 
towels (29 CFR 1928.110). In light of the OSHA definition and comments, 
we are revising Sec.  112.130(b)(3), which requires that hand-washing 
facilities be furnished with adequate drying devices, to revise the 
examples of ``adequate drying devices'' to no longer include ``clean 
cloth towels'' because the repeated use of towels or use by multiple 
users can increase the potential for contamination (Ref. 103). We are 
also revising the list of examples to include electric hand dryers, 
which we agree can be adequate drying devices. We acknowledge that this 
provides additional flexibility compared to OSHA's field sanitation 
standards; however, this provision does not prevent covered farms that 
are subject to this OSHA requirement from complying with the OSHA 
requirement. We also note that our list of examples is not intended to 
be exhaustive.
    (Comment 360) With respect to the provision related to hand 
antiseptic/sanitizer in proposed Sec.  112.130(d), some comments state 
that although hand antiseptic/sanitizer or wipes may not be a 
substitute for soap and water, this requirement prohibits the use of 
future innovation in hand sanitizers. Comments recommend revising this 
requirement to read ``. . . as a substitute for soap and water unless 
validated by the manufacturer as effective for that purpose.''
    (Response) As discussed in the 2013 proposed rule, ``hand 
sanitizers'' have not been found to be effective

[[Page 74495]]

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 prohibiting the use of antiseptic hand 
rubs because such products 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. Should there be advancements in product 
development in this area, we will consider revisiting this issue in the 
future, as needed. We recognize, however, that effective surfactants 
other than soap may be used in lieu of soap during hand-washing, and we 
are revising Sec.  112.130(d) to be consistent with Sec.  
112.130(b)(1), which we are retaining as proposed. We are also revising 
Sec.  112.130(d) to use the term ``antiseptic hand rubs'' to 
collectively refer to leave-on antiseptic products, such as hand 
sanitizers or wipes.

G. Controlling Animal Excreta and Litter From Domesticated Animals 
(Sec.  112.134)

    (Comment 361) One comment requests clarification on whether Sec.  
112.134 would allow cats and dogs to be present on produce farms if the 
farmer can demonstrate reasonable precautions that can reasonably 
minimize the risk of their excreta contaminating covered produce.
    (Response) You are permitted to have cats or dogs on your covered 
farm, provided that under Sec.  112.134 you (1) adequately control 
their excreta and litter and (2) maintain a system for control of their 
excreta and litter. These measures are necessary to prevent 
contamination of covered produce, food-contact surfaces, areas used for 
a covered activity, agricultural water sources, and agricultural water 
distribution systems with waste from your cats or dogs. In addition, 
you must comply with the requirements of Sec.  112.127 regarding 
domesticated animals in and around a fully-enclosed building, and, when 
applicable, the requirements related to animals in subpart I.

XVIII. Subpart M--Comments on Sprouts

    In subpart M of proposed part 112, we proposed to establish 
science-based minimum standards specific to 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 (in 
combination with the standards in other subparts of part 112 that also 
would apply to sprout operations). We tentatively concluded that it is 
necessary to incorporate this subpart establishing additional standards 
specific to sprouts because sprouts present a special concern with 
respect to human pathogens compared to other covered produce. We asked 
for comment on our proposed provisions in subpart M for sprouts, 
including on whether, or to what extent, the measures in this subpart 
should be applied to soil-grown sprouts; and 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 requested comments on whether a supplier approval and 
verification program for seeds and beans intended for sprout production 
is practical and effective.
    We are finalizing these provisions with several revisions (See 
Table 24). We discuss these changes in this section.

             Table 24--Description of Revisions to Subpart M
------------------------------------------------------------------------
                                                       Description of
      Proposed provision         Final provision         revisions
------------------------------------------------------------------------
                                Sec.   112.141...  --New section to
                                                    describe the scope
                                                    of subpart M.
Sec.   112.141................  Sec.   112.142...  --Revision to combine
                                                    all requirements for
                                                    seeds and beans into
                                                    Sec.   112.142.
                                                   --Revision to Sec.
                                                    112.142(b) to
                                                    include a
                                                    requirement to
                                                    discontinue use of a
                                                    lot of seeds or
                                                    beans that you know
                                                    or have reason to
                                                    believe may be
                                                    contaminated with a
                                                    pathogen due to
                                                    association with
                                                    foodborne illness or
                                                    positive microbial
                                                    test results and
                                                    adding actions that
                                                    must be taken with
                                                    regard to a lot that
                                                    may be contaminated.
                                                   --Revision to
                                                    establish in Sec.
                                                    112.142(c) certain
                                                    limited
                                                    circumstances under
                                                    which you are not
                                                    required to take the
                                                    steps set forth in
                                                    Sec.   112.142(b).
Sec.   112.142................  Sec.   112.143...  --Revision to
                                                    summarize in this
                                                    section all measures
                                                    that need to be
                                                    taken for growing,
                                                    harvesting, packing,
                                                    and holding, with
                                                    relevant cross-
                                                    references to other
                                                    parts of subpart M.
                                                    (We have added Sec.
                                                     112.143(c)
                                                    referring to testing
                                                    requirements in Sec.
                                                      112.144; Sec.
                                                    112.143(d) referring
                                                    to the written
                                                    environmental
                                                    monitoring plan
                                                    required in Sec.
                                                    112.145; Sec.
                                                    112.143(e) referring
                                                    to the actions you
                                                    must take when
                                                    Listeria spp. or L.
                                                    monocytogenes is
                                                    detected in the
                                                    growing, harvesting,
                                                    packing, or holding
                                                    environment as
                                                    required in Sec.
                                                    112.146; Sec.
                                                    112.143(f) referring
                                                    to the written
                                                    sampling plan
                                                    required in Sec.
                                                    112.147, and Sec.
                                                    112.143(g) referring
                                                    to the actions you
                                                    must take when
                                                    samples of spent
                                                    irrigation water or
                                                    sprouts test
                                                    positive for a
                                                    pathogen as required
                                                    in Sec.   112.148.)
                                                   --Revision to move
                                                    requirement for
                                                    treating seeds and
                                                    beans into Sec.
                                                    112.42.
Sec.   112.143................  Sec.   112.144...  --Revision to clarify
                                                    the soil-grown
                                                    sprouts example in
                                                    Sec.
                                                    112.144(b)(2).
                                                   --Addition of new
                                                    Sec.   112.144(c),
                                                    and revision to Sec.
                                                      112.144(b), to
                                                    require additional
                                                    pathogen testing
                                                    when certain
                                                    specified criteria
                                                    are met.

[[Page 74496]]

 
Sec.   112.144................  Sec.   112.145...  --Revision to clarify
                                                    that you must
                                                    aseptically collect
                                                    environmental
                                                    samples in Sec.
                                                    112.145(d).
                                                   --Addition of
                                                    requirement in Sec.
                                                     112.145(e) that
                                                    your written
                                                    environmental
                                                    monitoring plan must
                                                    include a corrective
                                                    action plan that
                                                    details the actions
                                                    you will take if the
                                                    environment tests
                                                    positive for
                                                    Listeria spp. or L.
                                                    monocytogenes.
Sec.   112.145................  Sec.   112.146...  --New provision Sec.
                                                     112.146(f) to
                                                    indicate that you
                                                    must take
                                                    appropriate action
                                                    to prevent any food
                                                    that is adulterated
                                                    from entering
                                                    commerce.
Sec.   112.146................  Sec.   112.147...  --Addition of
                                                    requirement in Sec.
                                                     112.147(b) that you
                                                    must not allow a
                                                    production batch of
                                                    sprouts to enter
                                                    commerce until you
                                                    receive negative
                                                    pathogen testing
                                                    results on spent
                                                    sprout irrigation
                                                    water or sprouts.
                                                   --Addition of
                                                    requirement in Sec.
                                                     112.147(c) that
                                                    your written
                                                    sampling plan must
                                                    include a corrective
                                                    action plan if your
                                                    spent irrigation
                                                    water or sprouts
                                                    test positive for a
                                                    pathogen.
                                Sec.   112.148...  --New section to
                                                    describe actions
                                                    that must be taken
                                                    if spent irrigation
                                                    water or sprouts
                                                    test positive for E.
                                                    coli O157:H7,
                                                    Salmonella spp., or
                                                    a pathogen
                                                    identified in
                                                    accordance with Sec.
                                                      112.144(c).
Sec.   112.150................  Sec.   112.150...  --Revision to Sec.
                                                    112.150(b)(3) to
                                                    clarify
                                                    recordkeeping
                                                    requirement related
                                                    to written sampling
                                                    plan for each
                                                    production batch of
                                                    sprouts in
                                                    accordance with Sec.
                                                      112.147(a) and
                                                    (c).
                                                   --Revision to Sec.
                                                    112.150(b)(4) to
                                                    require
                                                    documentation of
                                                    results of all
                                                    analytical testing
                                                    conducted to comply
                                                    with subpart M.
                                                   --Revision to Sec.
                                                    112.150(b)(5) to
                                                    clarify
                                                    recordkeeping
                                                    requirement related
                                                    to any analytical
                                                    methods used in lieu
                                                    of methods
                                                    incorporated by
                                                    reference in Sec.
                                                    Sec.   112.152 and
                                                    112.153.
                                                   --Elimination of
                                                    proposed Sec.
                                                    112.150(b)(6) as a
                                                    corresponding change
                                                    to final Sec.
                                                    112.150(b)(5).
                                                   --Addition of new
                                                    provision (i.e.,
                                                    final Sec.
                                                    112.150(b)(6)) to
                                                    clarify the
                                                    recordkeeping
                                                    requirement for
                                                    actions taken in
                                                    accordance with Sec.
                                                     Sec.   112.142(b)
                                                    and (c), 112.146,
                                                    and 112.148.
------------------------------------------------------------------------

A. General Comments

    (Comment 362) Several comments agree with FDA's proposal to 
establish additional standards specific to sprouts in subpart M. In 
contrast, one comment maintains that the proposed requirements for 
sprouts are unlikely to improve the safety of sprouts, and argues there 
is little known about the causes of sprout contamination and that many 
interventions, such as seed treatments, occur before sprouting whereas 
most pathogens of concern are introduced or proliferate during 
sprouting. Several comments also mention that additional research is 
needed to improve the safety of sprouts.
    (Response) We are finalizing the rule with certain sprout-specific 
requirements in subpart M. We disagree with the comment arguing that 
little is known about the causes of sprout contamination. We have 
learned much in this area through extensive direct experience 
conducting inspections at sprout operations, as well as investigations 
to follow-up on foodborne illness outbreaks and/or positive sample 
findings. We also published guidances to industry (Ref. 97) (Ref. 206), 
and issued a letter to suppliers and distributors of seeds and beans to 
urge firms to review their operations in light of our guidances and 
other available information (Ref. 207), and to modify their operations 
accordingly. FDA's 2014 sprouts assignment suggested that although many 
operations were taking some steps to implement at least some of the 
recommendations in our sprout guidances, this effort was not universal 
across sprout farms visited nor was it across all recommendations 
within a single operation (Ref. 208).
    Sprouts have been frequently associated with foodborne illness 
outbreaks. Between 1996 and 2010, there were a total of 34 outbreaks, 
2,150 illnesses, and 123 hospitalizations associated with sprouts (Ref. 
26) (Ref. 27). Moreover, there have been an additional nine outbreaks 
associated with sprouts, accounting for 255 illnesses and 48 
hospitalizations, between 2011 and 2014, including the first documented 
L. monocytogenes sprout outbreak in the United States that resulted in 
deaths (Ref. 28).
    We have relied on available science and evidence to inform the 
development of the sprout-specific requirements in subpart M. For 
example, it is well-established that sprouts can become contaminated 
through the use of contaminated seeds for sprouting, and we are aware 
of outbreaks associated with multiple sprout farms using the same lot 
of seed (Ref. 29). In addition, although treatment of seeds prior to 
sprouting does not guarantee pathogen-free sprouts, treatment can be 
expected to reduce the percentage of contaminated batches (Ref. 209) 
(Ref. 210). Therefore, we are including certain requirements applicable 
to seeds or beans used to grow sprouts to help prevent seeds and beans 
from serving as a vehicle for introducing contamination in sprouts. We 
are also requiring testing of spent sprout irrigation water (or 
production batches of sprouts) for certain pathogens, which is 
consistent with current recommendations in our guidances, and existing 
international guidelines and regulations (Ref. 23) (Ref. 211) (Ref. 
212) (Ref. 213). Such testing is appropriate in addition to the seed 
treatment requirements because pathogens that are not eliminated by 
seed treatment could potentially grow out again when subjected to 
enrichment conditions, as experienced during sprouting (Ref. 21) (Ref. 
23). We are also requiring testing the growing, harvesting, packing, 
and holding environment for Listeria spp. or L. monocytogenes. 
Contamination from L. monocytogenes from the environment is

[[Page 74497]]

common (Ref. 214) and, thus, targeted preventive controls to minimize 
L. monocytogenes in sprouts are warranted. While appropriate sanitation 
measures can minimize the presence of environmental pathogens in a 
sprouting operation, we conclude that environmental monitoring is still 
necessary for sprouting operations as an added safety measure. There 
have been positive sample findings and multiple recalls associated with 
L. monocytogenes in sprouts (Ref. 215) (Ref. 216) (Ref. 217). Between 
2002 and 2015, there have been 28 recalls involving multiple sprout 
types due to potential or confirmed contamination with L. monocytogenes 
(Ref. 218). 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. 215). Moreover, we are adding a 
requirement that sprout operations must not allow the production batch 
of sprouts to enter commerce unless the results of the testing of spent 
sprout irrigation water or sprouts are negative for certain specified 
pathogens (see Sec.  112.147(b)). This requirement is consistent with 
current industry best practices (Ref. 219). Together with new Sec.  
112.148(a), this requirement will help ensure that sprout operations 
take appropriate steps to prevent contaminated sprouts from entering 
commerce.
    We discuss these and other sprout-specific requirements in greater 
detail in this section. For additional information, see also sections 
II and V.M of the 2013 proposed rule.
    The requirements in subpart M are consistent with recommendations 
in FDA's guidances (Ref. 97) (Ref. 206), industry guidance (Ref. 219), 
and international regulations and guidelines (Ref. 23) (Ref. 211) (Ref. 
212) (Ref. 220).
    We intend to promote and support additional research in this area, 
as needed. In addition, seeds have been the source of contamination in 
many, but not all, sprout outbreaks (Ref. 21) (Ref. 26) (Ref. 27) (Ref. 
28)). Interventions applied before sprouting, such as those directed to 
seed, are meant to avoid, eliminate, or reduce pathogen load on seeds 
and, therefore, reduce the risk of pathogen proliferation during 
sprouting.
    (Comment 363) Some comments ask whether microgreens would be 
subject to subpart M and/or to the general provisions of part 112. Some 
comments maintain that, because differences in the length of the 
growing period and practices followed for microgreen production result 
in a lower risk for cross-contamination than in sprout production, 
microgreens should not be subject to requirements directed to sprouts. 
Other comments suggest microgreens are a ready-to-eat produce item that 
is growing in popularity and could carry risks similar to sprouts.
    (Response) Subpart M applies to the production of all types of 
sprouts, including alfalfa, clover, and mung bean sprouts, except for 
soil-grown sprouts harvested without roots (see Comment 364). FDA 
agrees that microgreens and sprouts are different products. Our 
longstanding guidances to industry on sprouts do not list microgreens 
as sprouts. This interpretation is also consistent with other public 
and private standards, e.g., the IFSH Sprout Taskforce sprout-specific 
audit check list and the Food Safety Australia New Zealand (FSANZ) 
standards for sprouts. In addition, in the 2013 proposed rule 
discussion of potential differences in practices and risk factors 
related to soil-grown versus hydroponically-grown sprouts, we did not 
specifically mention microgreens because we do not consider microgreens 
to be sprouts. Historically, the primary criterion FDA has used to 
distinguish between the two product categories has been the growth 
stage of the leaves (Ref. 221). Sprouts are usually harvested when the 
cotyledons (or seed leaves) are still un- or under-developed and true 
leaves have not begun to emerge. In contrast, microgreens reach a later 
stage of growth, typically associated with the emergence of ``true'' 
leaves. Microgreens are also typically grown in soil or substrate and 
harvested above the soil or substrate line. Because microgreens are not 
sprouts, they are not subject to the requirements in subpart M. 
However, microgreens are considered ``covered produce'' for the 
purposes of this rule and, unless exempt or excluded under the 
provisions in subpart A, microgreens and microgreen farms are subject 
to all other subparts of part 112.
    Additional research would be helpful to better define the risk 
profile of microgreens that are grown using conditions similar to those 
of sprouts (i.e., warm, moist, and nutrient-rich media) (Ref. 222). To 
the extent the specific microgreen production practices may present 
risks similar to those associated with sprouts, we encourage microgreen 
operations to consider voluntarily implementing the standards in 
subpart M, in addition to complying with the required provisions of 
part 112.
    (Comment 364) Some comments seek clarification on whether soil-
grown sprouts are covered under subpart M. One comment maintains that 
measures described under subpart M should be applied to both soil-grown 
and hydroponically-grown sprouts. This comment states that, although 
they are not aware of any outbreaks associated with sprouts grown in 
soil or media, contaminated soil has been a concern in the context of 
other produce commodities. In contrast, one comment requests different 
standards for soil-grown sprouts, and states that FDA should require 
that sprouters take steps to minimize cross-contamination between 
hydroponic and soil-grown sprouts.
    (Response) Soil- or substrate-grown sprout shoots that are 
harvested above the soil or substrate line, such that their roots are 
not harvested for human consumption, do not present the same risks as 
other types of sprouts and we are therefore excluding them from 
coverage under subpart M. We have added new Sec.  112.141 to address 
this. New Sec.  112.141 states that the requirements of subpart M apply 
to growing, harvesting, packing, and holding of all sprouts, except 
soil- or substrate-grown sprouts harvested without their roots. 
However, soil- or substrate-grown sprouts harvested above the soil line 
are ``covered produce'' and, unless exempt or excluded under the 
provisions of subpart A, are subject to all other applicable 
requirements of part 112.
    We believe the potential risks are sufficiently different between 
sprouts where the entire plant is consumed and sprout products that are 
harvested without the roots (Ref. 223) (Ref. 224). Microscopic 
examination of sprouts has been reported to show that pathogens target 
root hairs of sprouts for colonization, with presence of few viable 
cells elsewhere on the sprout, which indicates that root hairs provide 
a niche for pathogen proliferation (Ref. 224) (Ref. 225). Therefore, we 
do not see the need to apply the additional sprout-specific safety 
standards in subpart M to soil- or substrate-grown sprouts that are 
harvested above the soil or substrate line. However, we are applying 
the requirements of subpart M to soil- or substrate-grown sprouts that 
are harvested with the roots. We also agree that all hydroponically 
grown sprouts should be covered under subpart M. Under typical 
conditions for growing hydroponic sprouts, water runs through sprouts 
in the same growing unit, and any pathogens present in the seed or 
sprouting seed can spread throughout the production lot of sprouts 
(Ref. 21) (Ref. 226) (Ref. 227).
    To avoid any confusion about the applicability of subpart M to 
soil- or substrate-grown sprouts, we are also revising the term ``soil-
grown sprouts''

[[Page 74498]]

used as an example in proposed Sec.  112.143(b)(2) so that the example 
now refers specifically to ``soil-grown sprouts harvested with roots'' 
in final Sec.  112.144(b)(2). To the extent production practices for 
soil- or substrate-grown sprouts that are harvested above the soil or 
substrate line may present risks similar to those associated with other 
sprouts, we encourage such operations to consider voluntarily 
implementing the standards in subpart M, in addition to complying with 
the required provisions of part 112. We are also including, in the 
examples in renumbered Sec.  112.144(b)(2), ``hydroponically grown 
sprouts that use very little water,'' as another example for which 
testing spent sprout irrigation water may not be practicable such that 
you may, therefore, 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.  112.147.
    The potential for soil or substrate to be a source of contamination 
in a soil- or substrate-grown sprout operation is a valid concern, and 
we agree with comments stating that measures must be taken to minimize 
the risk of the soil or substrate serving as a source of contamination, 
for either sprouts grown in the soil or substrate, or for other produce 
that may be grown or handled at the sprout operation. We are 
establishing minimum science-based standards directed to biological 
soil amendments of animal origin and human waste under subpart F of 
part 112, which are applicable to all covered produce, including soil- 
or substrate-grown sprouts (however they are harvested).
    (Comment 365) Some comments question whether wheatgrass would be 
covered under subpart M as a sprout, particularly since the seed is not 
consumed whether grown hydroponically or in a medium.
    (Response) Sprouts, as a category, include many varieties, 
including wheatgrass. Wheatgrass has long been considered a sprout 
within the industry. For example, it was considered a sprout in the 
NACMCF recommendations (Ref. 21), the Sprout Testing Guide, and the 
FDA/CDPH sprout video (Ref. 228). We consider it a sprout for purposes 
of this rule and in particular for the application of subpart M of this 
rule. However, wheatgrass is typically grown in soil or substrate and 
harvested above the soil or substrate-line, and in those circumstances, 
it is not subject to subpart M.
    (Comment 366) One comment requests that we subject small onions 
that are thinned from a starter tray to the requirements of subpart M.
    (Response) We understand that some operations use a starter tray, 
where seeds are sown thickly, and then weaker seedlings are thinned 
out, providing the stronger seedlings with more space to grow. When 
small onions are grown in starter trays, some operations discard the 
produce resulting from the first thinning and others sell that produce 
for use as food. In terms of potential hazards associated with 
production, such produce is akin to soil- or substrate-grown sprouts 
that are harvested above the soil line or to microgreens, both of which 
we are not subjecting to the requirements of subpart M. Therefore, we 
conclude that small onions grown in flats should not be subject to the 
requirements of subpart M, and we are not subjecting them to the 
requirements of that subpart. Such produce is subject to the other 
requirements of part 112, as applicable, however.

B. Seeds or Beans Used To Grow Sprouts (Sec.  112.142)

    These requirements were proposed as Sec.  112.141. We have now 
renumbered this section as Sec.  112.142 as a consequential change from 
the addition of new Sec.  112.141.
    (Comment 367) Pointing out that seeds are often the source of 
contamination for sprouts, several comments argue that proposed subpart 
M lacks sufficient emphasis on the origin of seeds, their traceability, 
and the growing and production of seeds intended for sprouting. One 
comment suggests that seeds destined for sprouting should be labeled as 
such with the seed producer's name and full address. Some comments 
maintain that seeds and beans should be covered under the produce 
safety regulation, and that FDA should require seeds to be grown and 
produced under good agricultural practices and specifically for 
sprouting for human consumption, rather than being potentially sourced 
from fields where the seeds were intended to be directed toward animal 
feed production. Several comments also support a requirement for a 
supplier approval and verification program for seeds and beans received 
by sprouters for sprouting purposes (including seed lot testing and use 
of a HACCP approach). In this regard, one comment suggests FDA should 
require documentation of the processes that the seeds are subjected to 
during their cleaning and preparation for sale while another argues 
that unless seeds from a particular crop or variety can be produced in 
a safe manner, industry should be required to cease production of 
sprouts from that crop or variety.
    (Response) Since 1999, FDA has taken a number of steps to provide 
guidance to the sprouts industry, including those involved in the 
growing and production of seeds (78 FR 3504 at 3509). In developing 
this rule, FDA has carefully considered the growing and distribution of 
seeds for sprouting. As noted in the 2013 proposed rule, various crops 
may be grown to produce seeds and beans for sprouting with different 
production practices, growing seasons, conditions, and crop needs. 
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 are 
used for sprouting may vary. Therefore, we did not propose to prescribe 
specific provisions to prevent the introduction of known or reasonably 
foreseeable hazards into or onto seeds or beans during growing, 
harvesting, conditioning, or holding. Instead, we referred to our 
recommendations in relevant guidances, including the GAPs Guide (78 FR 
3504 at 3595).
    In the 2013 proposed rule, we considered proposing a supplier 
approval and verification program for seeds and beans received by 
sprout operations for sprouting purposes. Such 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, we also noted that a supplier approval and verification 
program may not be practical or effective for seeds and beans received 
by sprout operations for sprouting purposes because, for most crops, 
only a small percentage of the harvested seeds or beans is used for 
sprout production. In addition, seeds and beans 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 (at 78 FR 3504 at 3595-3596).
    Information we have received subsequent to the 2013 proposed rule 
suggests that seed distributors may request that their seed growers and 
handlers provide assurance, through the use of agreements, that safe 
growing and handling practices are employed during

[[Page 74499]]

the growing, harvesting, conditioning, storage, handling, and 
transportation of the seeds that the distributor will sell to sprouting 
operations (Ref. 229). In addition, we believe that proposed Sec.  
112.141(a) would not have been effective at addressing hazards 
associated with the growing of seeds or beans used for sprouts because 
few, if any, sprout operations in the United States grow their own 
seeds or beans but instead, receive the seeds or beans from other 
entities, such as seed growers or distributors (Ref. 230). It is 
important that this rule includes measures to prevent the introduction 
of known or reasonably foreseeable hazards into seeds or beans that are 
used for sprouting. Therefore, and in light of information that 
sprouting operations typically receive (rather than grow their own) 
seeds or beans, we are revising proposed Sec.  112.141(a), renumbered 
as Sec.  112.142(a), to require the sprout operation to take measures 
reasonably necessary to prevent the introduction of known or reasonably 
foreseeable hazards into or onto seeds or beans that they will then use 
for sprouting regardless of whether the sprouter also grew the seeds or 
beans.
    Measures required under renumbered Sec.  112.142(a) include, for 
example, keeping the seed storage area clean and dry, and dedicated to 
seed storage. Seed containers must be tightly covered or closed, stored 
off the floor and away from the walls, clean, identified with lot 
numbers, and, for reusable containers, emptied, cleaned, and sanitized 
between uses. Sprout operations must also complete a visual examination 
of seeds/beans and their packaging upon receipt and prior to use for 
potential contamination (e.g. visual exam and/or black light/UV exam of 
seed bags for evidence of insects, rodents, or other contamination).
    As noted previously, we also asked for comment on a seed supplier 
program. While we believe that the agreements and assurances made 
between seed suppliers and other entities in the supply chain providing 
assurances that the seeds and beans have been grown and handled under 
good agricultural practices and that seeds that may be used for 
sprouting have been conditioned, stored, and transported in a manner 
that minimizes the likelihood that the seeds will be contaminated with 
pathogens, are valuable, we are not requiring that sprouters request, 
receive, or provide such agreements and assurances. We recommend these 
practices, consistent with recommendations in our 1999 guidance to 
industry, ``Reducing Microbial Food Safety Hazards for Sprouted 
Seeds,'' (the Sprout Guide) and recommendations or requirements by 
other competent authorities (Ref. 211) (Ref. 212) (Ref. 231), and are 
encouraged that some comments indicated that this is already happening. 
However, we do not believe that it is currently feasible for all seeds 
and beans used for sprouting to be produced under GAPs, particularly 
when the vast majority of seed is not produced for such use. If the 
situation changes, we may revisit this in the future. The other 
requirements in Sec.  112.142 also address potential contamination in 
seeds and beans.
    (Comment 368) Several comments state that sprout operations should 
not use sprouts if they have reason to believe that a lot of seeds or 
beans has been associated with foodborne illness. Comments also request 
that FDA further clarify that if a farm has reason to believe that a 
lot of seeds has been contaminated with a hazard likely to cause 
foodborne illness, the farm should not use that lot to produce sprouts, 
regardless of whether that contamination has caused illness. In this 
regard, one comment explains that farms will be unable to accurately 
and reliably assess whether a particular batch of seeds has been linked 
to consumer illness. Finally, one comment expresses concern with 
requiring sprout operations to discontinue use of a seed lot found to 
be contaminated through microbial testing. This commenter poses several 
questions regarding follow-up actions that a sprouter may have to take 
in response to a positive test finding.
    (Response) Proposed Sec.  112.141(b), now renumbered as Sec.  
112.142(b), focuses on reasonably necessary measures when it is known 
or there is reason to believe that a lot of seeds or beans that will be 
used for sprouting is contaminated. As proposed, Sec.  112.141(b) would 
have required 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. As discussed in the 
2013 proposed rule, we 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, and 
you must not use that lot of seeds or beans to produce sprouts (78 FR 
3504 at 3596). We are revising this section to make clear that relevant 
knowledge or reason to believe seeds or beans may be contaminated may 
be based either on an implication of the seeds or beans in a foodborne 
illness outbreak or on a positive microbial test result, including a 
finding made after testing spent sprout irrigation water or sprouts. 
For example, section 112.144(b) requires testing of spent sprout 
irrigation water from each production batch of sprouts or, if such 
testing is not practicable, testing of each production batch of sprouts 
at the in-process stage. In either circumstance, i.e., through 
implication in an outbreak or through microbial testing (including that 
required under Sec.  112.144(b)), the information gathered is 
sufficient to indicate that the lot of seeds or beans may be 
contaminated and there is reason to believe that other parts of that 
lot may also be contaminated. Therefore, we continue to believe that it 
is reasonably necessary to prevent the introduction of known or 
reasonably foreseeable hazards into sprouts that you discontinue use of 
all seeds or beans from that lot for sprout production (Sec.  
112.142(b)(1)). We are also expanding the duties you have under Sec.  
112.142(b) beyond simply not using the seeds or beans to produce 
sprouts, to include ensuring that sprouts grown from that lot of seeds 
or beans do not enter commerce (Sec.  112.142(b)(1)), and reporting the 
information (association with illness and/or findings of microbial 
testing) to the seed grower, distributor, supplier, or other entity 
from whom you received the seeds or beans (Sec.  112.142(b)(2)). Since 
the lot of seeds or beans may be contaminated, it is critical to 
discontinue use of the seeds and beans for sprout production for human 
consumption and ensure that sprouts grown from that lot do not enter 
commerce. Other national or international standards, too, require or 
recommend discontinuing use of a lot of seeds or beans that may be 
contaminated and is likely to present a health hazard (Ref. 23) (Ref. 
211) (Ref. 212).
    It is also important that the sprout operation report the findings 
to the entity (seed grower, distributor, or supplier) that supplied the 
seeds or beans so that the seed grower, distributor, or supplier, upon 
receiving such information, could then take appropriate follow-up 
actions, which may include reporting the finding to other buyers of the 
suspected lot of seeds or beans, destroying or diverting any remaining 
seed or beans to other uses, including non-food uses and/or 
investigating the potential source of contamination, as necessary. In 
such circumstance, where applicable, the seed grower, distributor, or 
supplier may be required to submit a report to the Reportable Food 
Registry (RFR), in

[[Page 74500]]

accordance with section 417 of the FD&C Act (21 U.S.C. 350d), which 
requires responsible parties for food facilities that are required to 
register under section 415 of the FD&C Act (21 U.S.C. 350d) to report 
certain information to FDA when there is a reasonable probability that 
the use of, or exposure to, an article of food will cause serious 
adverse health consequences or death to humans or animals.
    In addition, we are adding two provisions under new Sec.  
112.142(c) that apply only if your reason for believing the lot of 
seeds or beans may be contaminated is based only on microbial test 
results. First, we are providing that you do not have to take the steps 
in Sec.  112.142(b)(1) if you treat your lot of seeds or beans with a 
process that is reasonably certain to achieve destruction or 
elimination in the seeds or beans of the most resistant microorganisms 
of public health significance that are likely to occur in the seeds or 
beans (may also be referred to as a ``pasteurization'' step) ((Sec.  
112.142(c)(1)). We are including this option to allow sprout farms 
flexibility in responding to a finding that would otherwise mean they 
would have to discontinue use of the seeds and to encourage future 
innovation in seed treatment processes. However, we note that processes 
that meet the description in (c)(1) are not currently commonly used in 
the sprouting industry. Such processes are far more robust than the 
seed treatment processes described in Sec.  112.142(e) because the seed 
treatments described in Sec.  112.142(e) typically only reduce 
microorganisms of public health significance (these treatments do not 
eliminate or destroy pathogens), and are therefore part of a multi-
hurdle risk reduction framework that also includes spent irrigation 
water or sprout testing for pathogens on a lot by lot basis. 
Irradiation is an example of a process that may be able to meet the 
description in Sec.  112.142(c)(1).
    Second, we are adding new Sec.  112.142(c)(2) to provide that you 
do not have to take the steps in Sec.  112.142(b)(1) and (2) if you 
later reasonably determine through appropriate follow-up actions that 
the lot of seeds or beans is not the source of contamination (for 
example, the lot of seeds or beans is not the source of a pathogen 
found in spent sprout irrigation water or sprouts).
    We expect that the situations in which you could take follow-up 
actions that would be adequate to make a reasonable determination that 
the lot of seeds or beans was not the source of the contamination are 
not extensive. However, the following are examples of situations in 
which we believe such a determination might be appropriate:
    1. Seed lot A is recalled by the seed supplier due to contamination 
with Salmonella while an operation has sprouting in process with that 
seed lot. The sprout operation immediately stops production of sprouts 
using seed lot A, disposes of the sprouts and returns unused seed to 
the distributor. The sprouts operation cleans the equipment and starts 
using the same equipment to grow another batch of sprouts using seed 
lot B. Spent irrigation water from the next lot of sprouts using seed 
lot B then tests positive for Salmonella, and follow-up sample analysis 
shows the same Salmonella serotype that was identified as contaminating 
seed lot A. The sprout operation discovers that cleaning and sanitizing 
protocols were not followed properly following sprout production using 
seed lot A, and swabs the equipment and finds a matching Salmonella 
serotype on the equipment that had been used to sprout both seed lots A 
and B. After adequately and thoroughly re-cleaning and sanitizing the 
equipment and re-testing food-contact surfaces for Salmonella with 
negative results, the sprout operation starts a new production batch of 
sprouts using seed lot B as a follow-up action to the positive test 
result to determine whether seed lot B may also be contaminated. The 
second time, all spent irrigation water tests from seed lot B sprouts 
come back negative. In this circumstance, the sprout operator could 
reasonably conclude that seed lot A had contaminated the equipment, 
which was not initially adequately cleaned and sanitized and therefore 
contaminated the first batch of sprouts produced from seed lot B. If 
the farm is following appropriate follow-up sanitation procedures, 
spent irrigation water from seed lot B is no longer testing positive 
for Salmonella, under these circumstances the farm may reasonably 
conclude that seed lot B was not the source of contamination that 
generated the positive test result when testing spent irrigation water 
from seed lot B sprouts. We note that in general a negative test for 
seeds or spent irrigation water would not, by itself, be enough 
evidence that seed lot B was not contaminated. However, in this 
example, the seed supplier's Salmonella serotype result from seed lot A 
that matches serotype found in the positive spent irrigation water 
sample and the swab from equipment used to sprout seed lot B, combined 
with the improper cleaning and sanitizing of equipment, negative 
subsequent test results, and the intervening improvements in cleaning 
procedures, supports the conclusion that the positive spent irrigation 
water sample from sprouts made with seed lot B was most likely due to 
contamination of shared production equipment with seed lot A.
    2. A sprout operation mixes two seed lots (lot A and B) together to 
result in a mixed sprout product for which the spent irrigation water 
tests positive for Salmonella. The sprout operation could sprout each 
seed lot individually. If upon follow-up serotype sample analysis, 
spent irrigation water from only one seed lot (lot A) tests positive 
for Salmonella matching the original positive, the sprout operation 
could reasonably determine that seed lot A was the source of the 
Salmonella positive in spent irrigation water from the mixed seed 
sprouts. The sprout operation would be required to discontinue use of 
all seeds from the affected seed lot for sprout production (unless it 
treats the seed lot in accordance with Sec.  112.142(b)(1)), ensure 
that sprouts grown from that seed lot do not enter into commerce, and 
report the information to the grower, distributor, supplier, or other 
entity from whom the farm received the seeds, in compliance with Sec.  
112.142(b). Under Sec.  112.142(c), the sprout farm could continue to 
use seed lot B, provided there were no subsequent positive test results 
and no information suggesting association of that seed lot with 
foodborne illness.
    We recognize that there may be other microbial testing through 
which you may conclude that a lot of seeds or beans is contaminated. 
For example, testing of seeds (although not required under this rule) 
using statistically valid sampling and testing protocols may lead you 
to conclude that seeds or beans are contaminated. Information of this 
kind triggers the requirements in Sec.  112.142(b) and requires farms 
to discontinue use of all seeds or beans from that lot, ensure that 
sprouts grown from that lot of seeds or beans do not enter commerce, 
and report the information to the grower, distributor, supplier, or 
other entity from whom the farm received the seeds.
    Although we believe there may be follow-up actions that could allow 
a sprout operation to determine that a lot of seeds or beans that had 
been associated with a positive microbial test result from testing 
spent sprout irrigation water or sprouts at their operation (required 
under Sec.  112.144(b)) were not the source of contamination, we do not 
believe the same is true of a lot of seeds or beans that have been 
associated with a foodborne illness. We are not aware of actions that a 
sprout farm could take to demonstrate that the lot of seeds or beans 
was not the source

[[Page 74501]]

of contamination following an outbreak of foodborne illness. A sprout 
farm, along with regulators, may make a determination that the farm's 
seeds or beans were not associated with a foodborne illness outbreak, 
but it is unlikely that the sprout farm would have adequate information 
(e.g., epidemiological data and traceback information) to make that 
determination independently. Therefore, we are not providing a similar 
option to Sec.  112.142(c) applicable in instances where there is 
knowledge or reason to believe that a lot of seeds or beans has been 
associated with foodborne illness.
    (Comment 369) One comment asked whether, in sprout production, 
sampling and testing can be properly defined as a process control, or 
whether it should be defined simply as a confirmation that a process 
control has worked as intended. The comment maintained that if sampling 
and testing is a process control then a positive test may not be 
grounds for discontinuation of a seed lot since the control worked as 
intended.
    (Response) In the case of sprouts, sampling and testing of spent 
sprout irrigation water can be viewed as both a verification of a 
process control (e.g. of seed treatment) as well as a process control 
itself (``hold and release'' testing that is used to prevent a 
contaminated lot from entering commerce (see Sec.  112.147(b)). Even if 
a sprout operation's spent irrigation water testing is effective and 
identifies pathogen-positive lots of sprouts where seed treatment 
failed to eliminate a pathogen, the fact remains that seed is most 
often the source of contamination and that current seed treatments 
cannot guarantee the elimination of pathogens on seed. Currently 
available seed treatments typically reduce, but do not eliminate, 
pathogen presence on seeds, and these pathogens could potentially 
multiply when subjected to enrichment conditions, such as those 
experienced during sprouting. We view spent irrigation water sampling 
and testing as an additional reasonably necessary food safety measure 
to help ensure that contaminated product is not marketed. This measure 
is consistent with FDA's Sprout Testing Guide and also consistent with 
the Codex Guide. See also revised and renumbered Sec.  112.142 and new 
Sec.  112.148.
    (Comment 370) Some comments request that FDA either specify 
``pathogens of concern'' that are the most often associated with 
foodborne illness linked to sprouts (e.g., Salmonella, E. coli O157:H7, 
and L. monocytogenes) in proposed Sec.  112.141(a), or add language 
such as ``contaminated with a hazard likely to cause foodborne 
illness'' to that provision.
    (Response) For the purposes of the produce safety regulation, in 
Sec.  112.3, we define ``hazard'' to mean ``any biological agent that 
has the potential to cause illness or injury in the absence of its 
control'' and ``known or reasonably foreseeable hazard'' to mean a 
hazard that is known to be, or has the potential to be, associated with 
the farm or the food. Given these definitions, we believe it is not 
necessary or appropriate to specify ``hazard likely to cause foodborne 
illness'' within Sec.  112.142(a). We also do not believe it necessary 
or appropriate to list specific pathogens of concern or those most 
often associated with sprout-related illness outbreaks in lieu of the 
phrase ``known or reasonably foreseeable hazards'' in Sec.  112.142(a). 
Although we agree that Salmonella, E. coli O157:H7, and L. 
monocytogenes have been most often implicated in sprout-related illness 
outbreaks, there may be other biological agents with the potential to 
cause illness or injury that may be associated with the sprouting farm 
or sprouts. We conclude that we should not restrict the scope of 
hazards that are expected to be controlled under this provision. See 
discussion under Comment 375 of other pathogens that have been 
associated with sprouts.
    (Comment 371) One commenter believes that seed suppliers should be 
required to test seed for the presence of pathogens using statistically 
valid sampling and testing protocols and to provide sprout operations 
with a Certificate of Analysis for the seeds and beans, despite the 
recognized limitations of testing.
    (Response) We considered and tentatively rejected this approach in 
the 2013 proposed rule, and the commenter did not provide any new 
information suggesting we should change our conclusion. We recognize 
that at least one other competent authority has established 
microbiological criteria and requirements for testing all batches of 
seeds intended for sprouting (i.e., European Commission Regulation No. 
2073/2005). However, as explained in the 2013 proposed rule, 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. 21) and laboratory analyses have 
frequently been unable to isolate pathogens from implicated seeds or 
beans (Ref. 223). Nevertheless, we recognize that a positive test 
result can detect contaminated seeds and beans even though a negative 
test result is not a guarantee of the absence of pathogens. Therefore, 
we encourage seed suppliers and sprouters to test seed using 
statistically valid sampling and testing protocols. However, we 
continue to believe that testing seeds and beans is not sufficiently 
reliable to require it as a measure necessary to prevent the 
introduction of known or reasonably foreseeable hazards into sprouts.

C. Growing, Harvesting, Packing, and Holding Sprouts (Sec.  112.143)

    These requirements were proposed as Sec.  112.142. We have now 
renumbered this section as Sec.  112.143 as a consequential change from 
the addition of new Sec.  112.141. For purposes of clarification, we 
are revising final Sec.  112.143 to summarize under this section the 
various measures related to the growing, harvesting, packing, and 
holding of sprouts required in this subpart M, with relevant cross-
references to other sections of subpart M. Thus, we have added Sec.  
112.143(c) referring to testing requirements in Sec.  112.144; Sec.  
112.143(d) referring to the written environmental monitoring plan 
required in Sec.  112.145; Sec.  112.143(e) referring to the actions 
you must take when Listeria spp. or L. monocytogenes is detected in the 
growing, harvesting, packing, or holding environment as required in 
Sec.  112.146; Sec.  112.143(f) referring to the written sampling plan 
required in Sec.  112.147, and Sec.  112.143(g) referring to the 
actions you must take when samples of spent irrigation water or sprouts 
test positive for a pathogen as required in Sec.  112.148.
    In addition, because the requirement for seed treatment proposed as 
Sec.  112.142(c) establishes standards applicable to seeds and beans 
used for sprouting, it fits more directly under final Sec.  112.142 
rather than under final Sec.  112.143 (which was proposed as Sec.  
112.142). Therefore, we are moving this provision, as revised, into 
renumbered final Sec.  112.142 and finalizing it as Sec.  112.142(e). 
We discuss other changes to this provision in response to Comment 368.
    (Comment 372) Several comments agree with our proposed requirement 
for sprout operations to treat seeds or beans used for growing sprouts, 
and that prior treatment would not eliminate the sprout farm's 
responsibility for treatment immediately before sprouting. A number of 
these comments encourage FDA to support research to determine effective 
means of seed treatment prior to sprout production. Some comments 
express concern that this rule may require treatment of seeds using 
extremely high levels of chlorine (e.g., 20,000 ppm), and recommend 
allowing alternative effective treatments. One commenter believes seed 
treatment

[[Page 74502]]

resulting in at least a 3-log pathogen reduction should be required. 
Another comment suggests using the term ``disinfect'' rather than 
``treat'' when referring to seed treatments. Some comments also ask 
that FDA not require seeds to be treated immediately before sprouting, 
and urge FDA to create an information-sharing portal where sprout farms 
can share valid treatment and testing methods and data to better inform 
the sprout community. Another comment requests that FDA reconsider 
allowing for the use of ``proprietary research'' to determine the 
scientific validity of seed treatment. Finally, one comment suggests 
that FDA require seeds used for sprouting to be irradiated by the seed 
supplier, noting that this sprout operation's foreign seed supplier 
currently treats seeds in this manner.
    (Response) We are retaining the term ``treat'' when referring to 
seed treatments because of its longstanding use in our guidances to 
industry and common use within the sprouts industry. Moreover, because 
most current seed treatments cannot guarantee the elimination of 
pathogens, we conclude that the term ``disinfect'' would not be an 
appropriate description. (See also Comment 368 comparing most current 
treatment processes to more robust treatments processes that are 
reasonably certain to achieve destruction or elimination in the seeds 
or beans of the most resistant microorganisms of public health 
significance that are likely to occur in the seeds or beans).
    FDA has been working independently and in collaboration with others 
to develop a framework to conduct research on effective seed 
treatments, and we will support a variety of mechanisms to make this 
information available to sprout farms. For example, we are working 
through the SSA to facilitate development of an educational curriculum 
and sharing of best practices among sprout farms. We acknowledge that 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. 21). 
We cited 20,000 ppm calcium hypochlorite treatment in the Sprout Guide 
and in the 2013 proposed rule as an example of a treatment that has 
been shown to be effective for the reduction of pathogens. However, 
Sec.  112.142(e) (proposed Sec.  112.142(c)) allows you to use any 
scientifically valid method to treat seeds or beans that will be used 
to grow sprouts. We are also not precluding the use of proprietary seed 
treatments. We would expect a farm using a proprietary seed treatment 
to take steps to ensure that it is in compliance with all relevant 
laws, including FIFRA, if applicable, and to ensure that its treatment 
is effective in reducing pathogens on seed. In the event of an 
inspection or investigation of a sprout operation, we may ask to review 
the science supporting the use of the proprietary treatment to ensure 
the scientific validity of the treatment.
    We use the term ``scientifically valid'' in this rule 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. Our use of proprietary research in this 
context is consistent with our considerations in other rulemakings (see 
Current Good Manufacturing Practice Requirements for Dietary 
Ingredients and Dietary Supplements; 68 FR 12157 at 12198).
    Under proposed Sec.  112.142(c), we proposed to require sprout 
operations to treat seeds or beans using a scientifically valid method 
immediately before sprouting to reduce microorganisms of public health 
significance. We have since conducted a thorough review of currently 
available treatment methods as well as treatment methods under 
development and evaluation. Based on this review, we conclude that 
there are treatment methods that can be effectively applied by a 
grower, handler, or distributor of seeds or beans such that, when 
followed by good handling and packaging procedures, they can eliminate 
the need for follow-up treatment of the seeds or beans at the farm 
immediately before sprouting (Ref. 232). For example, as suggested by a 
commenter, irradiation is an option for seed treatment that could be 
applied by a seed supplier, handler, or distributor to reduce 
microorganisms of public health significance that may not be feasible 
for a sprout farm to apply on-site. In addition, hot water treatments 
have been demonstrated to reduce pathogens on seeds by more than 5 log 
CFU/g in one study (Ref. 233) and to undetectable levels in another 
(Ref. 234). However, these treatments can require use of equipment such 
as industrial-sized hot water pasteurization machines (Ref. 235) that 
might be cost-prohibitive for a small sprout farm. Therefore, in final 
Sec.  112.142(e)(1), we are removing the requirement to treat seeds or 
beans used for sprouting ``immediately before sprouting'' as well as 
the provision that stated ``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.'' We are also adding Sec.  112.142(e)(2) to 
explicitly allow covered sprout farms to rely on prior treatment of 
seeds or beans conducted by a grower, distributor, or supplier of the 
seeds or beans (whether to fulfill this requirement completely or for 
the purpose of considering such prior treatment when applying 
appropriate additional treatment of the seeds or beans at the covered 
sprout farm immediately before sprouting), provided that you obtain 
documentation (such as a Certificate of Conformance) from the grower, 
distributor, or supplier of the seeds or beans that (i) the prior 
treatment was conducted using a scientifically valid method to reduce 
microorganisms of public health significance; and (ii) the treated 
seeds or beans were handled and packaged following the treatment in a 
manner that minimizes the potential for contamination.
    Finally, as discussed previously, because this provision 
establishes standards applicable to seeds and beans used for sprouting, 
it fits more directly under final Sec.  112.142 rather than under final 
Sec.  112.143 (which was proposed as Sec.  112.142). Therefore, we are 
moving this provision, as revised, into renumbered final Sec.  112.142 
and finalizing it as Sec.  112.142(e). In addition, we are revising the 
corresponding recordkeeping provision in Sec.  112.150(b)(1) to require 
you to establish and keep documentation of your treatment of seeds or 
beans to reduce microorganisms of public health significance in the 
seeds or beans, at your farm; or alternatively, documentation (such as 
a Certificate of Conformance) from your seed supplier that seeds or 
beans are treated to reduce microorganisms of public health 
significance and are appropriately handled and packaged following the 
treatment, in accordance with the requirements of Sec.  112.142(e).

D. Testing During Growing, Harvesting, Packing, and Holding Sprouts 
(Sec.  112.144)

    These requirements were proposed as Sec.  112.143. We have now 
renumbered this section as Sec.  112.144 as a consequential change from 
the addition of new Sec.  112.141.
    (Comment 373) Some comments suggest that FDA issue through 
guidance, rather than in regulation, recommendations to test for 
pathogens that have been linked to a sprout outbreak causing human 
illness. Other comments support our proposed requirements for 
environmental testing

[[Page 74503]]

and testing of spent sprout irrigation water or sprouts.
    (Response) In developing the proposed provisions of subpart M, we 
tentatively concluded 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. We also tentatively 
concluded that testing spent sprout irrigation water or sprouts for E. 
coli O157:H7 and Salmonella spp. is a necessary measure to ensure the 
safety of sprouts. Given the outbreaks associated with sprouts and 
these pathogens, we are finalizing our conclusion that requiring this 
testing is warranted. These comments did not provide information that 
would change our conclusion.
    (Comment 374) Some comments state that requiring testing for 
Listeria at the genus level does not confirm the presence of a pathogen 
of interest and, therefore, recommend that FDA require testing for 
Listeria at the species level. In contrast, one comment states that 
frequent testing for Listeria would be expensive, arbitrary, and 
difficult to implement. The comment recommends that we instead require 
initial swab testing for Listeria, followed by a program of testing and 
cleaning until repeated tests are negative and, as an alternative, 
suggests that routine cleaning of equipment and facility inspections 
should be sufficient for controlling Listeria.
    (Response) The purpose of environmental monitoring is to verify the 
adequacy, or lack thereof, of cleaning and sanitizing practices through 
monitoring for the presence of pathogens in the environment and, if 
pathogens are present, to eliminate or minimize their presence and 
prevent transfer of pathogens to food-contact surfaces or to sprouts 
where they might cause illness. Testing for either the pathogen 
directly or an indicator organism facilitates accomplishing these 
objectives and, therefore, we are providing for the option to either 
directly test for L. monocytogenes (pathogen) or for an indicator 
organism (Listeria spp.). As discussed in the scientific literature, 
the term ``indicator organism'' means a microorganism or group of 
microorganisms that is indicative that (1) a food has been exposed to 
conditions that pose an increased risk for contamination of the food 
with a pathogen or (2) a food has been exposed to conditions under 
which a pathogen can increase in numbers (Ref. 236). Listeria spp. is 
an appropriate indicator organism for L. monocytogenes because tests 
for Listeria spp. will detect multiple species of Listeria, including 
L. monocytogenes (Ref. 237) (Ref. 238), and because the available 
information supports a conclusion that modern sanitation programs, 
which incorporate environmental monitoring for Listeria spp., have 
public health benefits (Ref. 239) (Ref. 240). With regard to the 
suggestion for initial swab testing with repeated cleaning until 
negative findings, we agree that negative findings from repeated tests 
indicate that current cleaning and sanitizing is likely effective. 
However, because Listeria can be reintroduced into the environment 
through different routes which can vary over time, it is important to 
continuously monitor the environment with routine sampling and testing, 
at a regular frequency, to verify effectiveness of cleaning and 
sanitizing practices.
    (Comment 375) With respect to testing of spent sprout irrigation 
water or sprouts in proposed Sec.  112.143(b), several comments express 
concern that additional pathogen strains may be associated with sprouts 
in the future, similar to the 2012 outbreak of E. coli O104:H4 linked 
to sprouts in Europe, and that requiring testing just for Salmonella 
and E. coli O157:H7 is too limited. Other comments were supportive of 
testing for Salmonella spp. and E. coli O157:H7. Another comment 
supports FDA's tentative decision not to require testing of spent 
irrigation water for Listeria, and believes that it would not be an 
appropriate use of resources to require such testing given the ubiquity 
of Listeria spp. in water and the limitations of current testing 
methods to detect L. monocytogenes.
    (Response) With respect to requiring testing of spent sprout 
irrigation water or sprouts, we focus on the two pathogens most 
commonly associated with sprout outbreaks, while also taking into 
consideration currently available analytical methodology. There is a 
long history of sprout-related outbreaks associated with E. coli 
O157:H7 and Salmonella spp. (Ref. 26) (Ref. 27) (Ref. 28) (Ref. 241) 
and we are retaining the requirement from proposed Sec.  112.143(b) in 
renumbered Sec.  112.144(b) for testing spent sprout irrigation water 
or sprouts for these two pathogens.
    We also recognize that two recent sprout-associated outbreaks in 
the United States, as well as the large 2012 sprout outbreak in Europe, 
were due to non-O157 STEC (Ref. 28). In the 2013 proposed rule, we 
requested comments on whether pathogens other than Salmonella spp. and 
E. coli O157:H7 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. We discussed the 
challenges of requiring testing for non-O157 STECs in the 2013 proposed 
rule (78 FR 3504 at 3598). For example, there are hundreds of serotypes 
of STECs, and many are non-pathogenic or of low pathogenicity such that 
detection of an STEC alone in spent sprout irrigation water or sprouts 
would not be necessarily indicative of a public health concern, as not 
all STECs cause illness. Moreover, although laboratory tests to detect 
non-O157 STECs are currently available, methods necessary for follow-up 
testing to determine pathogenicity are not readily available (Ref. 
242). We also considered requiring STEC testing for the major six 
pathogenic STEC serogroups (O26, O103, O111, O121, O45 and O145) 
identified by FSIS for non-intact raw beef. In addition, we reviewed 
the European Commission Regulation No. 209/2013, which amended 
Regulation No. 2073/2005 and established microbiological criteria for 
the testing of sprouts in an approach similar to that of FSIS' 
serogroup testing. Four serogroups, i.e., O26, O103, O111, and O145, 
are identified for testing in both the EC and FSIS approaches. However, 
available sampling data from the AMS' Microbiological Data Program 
(MDP) and from FDA's sampling assignments infrequently recovered these 
STECs from fresh produce, including sprouts (Ref. 242), and so it is 
not clear that these serogroups should be prioritized in terms of 
testing for sprouts. Because we recognize that in the future there may 
be additional pathogens associated with sprouts for which 
scientifically valid test methods become available such that testing 
for those additional pathogens would be warranted, we have revised 
Sec.  112.144(b) and added new Sec.  112.144(c) to address this 
situation.
    Revised Sec.  112.144(b) adds to the pathogens that covered sprout 
operations are required to test for in either spent sprout irrigation 
water or in-process sprouts ``any pathogens meeting the conditions 
identified in Sec.  112.144(c).'' New Sec.  112.144(c) requires sprout 
operations to conduct the tests required in Sec.  112.144(b) for 
additional pathogens when the following conditions are met: (1) Testing 
for the pathogen is reasonably necessary to minimize the risk of 
serious adverse health consequences or death from use of, or exposure 
to, sprouts; and (2) A scientifically valid test method is available to 
detect the pathogen in spent sprout irrigation water (or sprouts). 
These provisions require additional pathogen testing, in the future, if 
the criteria in Sec.  112.144(c) are met. First, the

[[Page 74504]]

association of the pathogen and sprout-related outbreaks or illness 
must be established to the point that routine testing for such a 
pathogen is reasonably necessary to protect public health and minimize 
the risk of serious adverse health consequences or death from use of, 
or exposure to, sprouts. As mentioned previously, both E. coli O157:H7 
and Salmonella spp. have a long history of association with sprout-
related illness. However, a new pathogen need not equal or surpass the 
history of association of E. coli O157:H7 and Salmonella spp. with 
sprout-related illness in order to warrant testing under Sec.  
112.144(b) and (c). To satisfy Sec.  112.144(c)(1), a new pathogen 
would need to have an established association with sprout-related 
illness. Second, there must be a scientifically valid test method 
available to detect the pathogen in spent sprout irrigation water (or 
sprouts). As mentioned previously with regard to STECs, we are not 
currently aware of an appropriate test to identify pathogenic non-O157 
STECs in spent sprout irrigation water (or sprouts) that is available 
to industry. However, test methods are continually under development 
and there will likely be improved methods in the future.
    In the event that, in the future, both criteria are met for a 
particular pathogen such that testing would be required, FDA intends to 
issue guidance in accordance with good guidance practices to advise 
sprout farms of FDA's assessment that: (1) There is a pathogen, in 
addition to E. coli O157:H7 and Salmonella spp., for which testing is 
reasonably necessary to minimize the risk of serious adverse health 
consequences or death from use of, or exposure to, sprouts, and (2) a 
scientifically valid test method is available to detect the pathogen in 
spent sprout irrigation water (or sprouts). In this guidance, we would 
address the history of the association of the pathogen and sprout-
related illness and also any relevant information about the testing 
protocol. We anticipate issuing such guidance initially as a draft for 
comment, unless, due to urgent circumstances, it is not feasible or 
appropriate to issue the document first in draft. Under those 
circumstances, we would invite comment on the final guidance, and 
revise it as appropriate. FDA intends to enforce the requirements for 
additional pathogen testing required in accordance with Sec.  
112.144(b) and (c) of this rule only after FDA issues a final guidance 
advising industry and the public of FDA's assessment that the criteria 
for additional pathogen testing have been met.
    With regard to testing spent sprout irrigation water for L. 
monocytogenes, for the reasons described in the 2013 proposed rule (78 
FR 3505 at 3597-3599) and in light of comments received, we conclude 
that, at this time, monitoring the environment, rather than spent 
sprout irrigation water, for Listeria spp. or L. monocytogenes is the 
most effective approach for controlling L. monocytogenes in a sprout 
operation (see next section).

E. Environmental Testing for Listeria Species or L. monocytogenes 
(Sec.  112.145)

    These requirements were proposed as Sec.  112.144. We have now 
renumbered this section as Sec.  112.145 as a consequential change from 
the addition of new Sec.  112.141.
    (Comment 376) Several comments agree with our proposed requirement 
for establishing and implementing a written environmental monitoring 
plan for Listeria. These comments maintain that it is critical that 
sprout farms recognize the importance of designing and maintaining a 
monitoring plan that is not simply compliant with regulations, but is 
also sufficiently tailored to their operations to be appropriately 
protective of public health. According to another comment, sprout farms 
currently routinely test spent irrigation water, but are not familiar 
with and do not currently utilize environmental monitoring.
    (Response) 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. 214) (Ref. 243). We 
conclude that testing the growing, harvesting, packing and holding 
environment for Listeria spp. or L. monocytogenes is a reasonably 
necessary measure to prevent the introduction of hazards into sprouts 
and to provide reasonable assurances that sprouts are not adulterated. 
Therefore, we are retaining the provisions of proposed Sec.  112.144 in 
renumbered Sec.  112.145, with three revisions. First, we are requiring 
that the sampling plan, a necessary aspect of the required 
environmental monitoring plan, must also specify the timing of 
collection of the environmental samples during production (see Sec.  
112.145(c)(2)). We believe this is an important addition to the 
sampling plan to ensure that sampling is conducted in a manner to 
optimize detection of Listeria, if present, and ensure consistency in 
the sampling strategy and facilitate the tailoring of the corrective 
action plan to the finding of a positive at a certain point during 
production. Second, we are requiring that environmental samples must be 
aseptically collected. This revision is consistent with proposed Sec.  
112.146(b) regarding aseptic collection of samples of spent sprout 
irrigation water or sprouts, which we are retaining in final Sec.  
112.147(b) (see also Comment 233 where we explain the importance of 
aseptic sampling). Third, we are requiring that the written 
environmental monitoring plan must include a corrective action plan 
that, at a minimum, requires you to take the actions in Sec.  112.146, 
and details when and how you will accomplish those actions, if the 
growing, harvesting, packing, or holding environment tests positive for 
Listeria spp. or L. monocytogenes (see Sec.  112.145(e)). Requiring 
that your written environmental monitoring plan include a corrective 
action plan aligns with the requirement for you to take appropriate 
actions under Sec.  112.146. Establishing and implementing a written 
corrective action plan will help ensure that corrective actions are 
taken quickly in response to positive findings of testing the 
production environment. This requires you to review appropriate sprout 
safety resources and consider the likely scenarios in advance of 
needing to take corrective actions, rather than reacting to these 
scenarios on an ad hoc basis after the fact. The requirement to have a 
written plan is consistent with other FDA food safety regulations, such 
as our juice and seafood HACCP regulations.
    (Comment 377) One comment suggests that daily verification of 
sanitation using rapid detection methods (such as bioluminescence, ATP, 
or protein tests) serves as a better indicator of sanitation than 
environmental sampling on food-contact surfaces.
    (Response) While rapid detection methods such as those mentioned 
are very useful for monitoring overall sanitation, they cannot 
substitute for environmental monitoring for Listeria spp. or L. 
monocytogenes to help ensure that L. monocytogenes has not become 
established in a harborage site, or niche, in a sprout operation. 
Cleaning and sanitizing may not remove all microorganisms and rapid 
methods such as those mentioned may not detect the presence of L. 
monocytogenes in harborage sites. However, daily monitoring of 
sanitation with a rapid

[[Page 74505]]

method such as those mentioned that allows for corrections to be made 
in ``real time'' if the cleaning and sanitizing have not been effective 
can be useful and we encourage sprout farms to use them in combination 
with required periodic sampling for Listeria spp. or L. monocytogenes 
to provide a robust approach to verifying cleaning and sanitization 
practices are adequately addressing L. monocytogenes in the 
environment.

F. Follow-Up Actions for Positive Environmental Testing Results (Sec.  
112.146)

    These requirements were proposed as Sec.  112.145. We have now 
renumbered this section as Sec.  112.146 as a consequential change from 
the addition of new Sec.  112.141.
    (Comment 378) Some comments state that the language in proposed 
Sec.  112.145(d) is insufficient for public health protection. One 
comment notes that the requirement as written will cause sprout farms 
to target sampling in order to achieve negative results with a minimum 
number of tests, rather than to target sampling to identify any 
potential sources of Listeria. According to another comment, finished 
product testing as a follow-up to a positive environmental finding is 
both useful and advisable, but is itself insufficient without a 
commensurate action step upon a positive result. This comment states 
that mandating testing throughout production and of finished product is 
a critically important part of ensuring that food is not contaminated--
but it is logically necessary that a discovery of contamination must 
carry an appropriate response. Some commenters also maintain that FDA 
should require the disposal of any food that has come into contact with 
contaminated water or production equipment.
    (Response) We agree that environmental monitoring is only effective 
when designed to identify L. monocytogenes if present and if followed 
by appropriate and effective corrective actions, where necessary. For 
this reason, we specify in Sec.  112.145(a) that sprout farms 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. As previously discussed, 
we are revising the rule to require that you establish and implement a 
written corrective action plan (as required under Sec.  112.145(e)) to 
help ensure that corrective actions are taken quickly in response to 
positive findings of testing the production environment. This requires 
you to consider the likely scenarios in advance, developed through 
review of appropriate sprout safety resources, rather than react to 
these scenarios on an ad hoc basis.
    Specifically with respect to renumbered Sec.  112.146(d), finished 
product testing can provide useful information in certain situations 
when pathogens have been detected in the environment. For example, 
finished product testing is likely appropriate if a food-contact 
surface tests positive for Listeria spp. in tests conducted following 
cleaning and sanitizing the surface to address an initial positive for 
Listeria spp., especially if production has occurred between the 
positive findings. The finding of Listeria spp. after a production run 
on a food-contact surface following corrective actions indicates that 
product contamination is reasonably likely, because it may indicate 
that the Listeria has become established in a niche on the equipment 
and is being dislodged during production. Our draft guidance to 
industry, the Listeria Guide (Ref. 244), includes draft recommendations 
for responses to positive environmental testing. A positive finding 
from environmental testing, as appropriate, can be confirmed through 
finished product testing and, if confirmed, necessary steps must be 
taken to remove the contaminated sprouts from the market and/or prevent 
contaminated sprouts from entering the market. We expect to address 
this issue further as we finalize the Listeria Guide. Accordingly, we 
are retaining in renumbered Sec.  112.146 the provisions proposed as 
Sec.  112.145 to require sprout operations to take certain minimum 
actions when there is a positive finding of L. monocytogenes or 
Listeria spp. in the production environment. Among these actions, 
listed in renumbered Sec.  112.146, we are also specifying that the 
sprout farm must take appropriate action to prevent any food that is 
adulterated under section 402 of the FD&C Act from entering into 
commerce (see Sec.  112.146(f)).

G. Collection and Testing of Samples of Spent Sprout Irrigation Water 
or Sprouts (Sec.  112.147)

    These requirements were proposed as Sec.  112.146. We have now 
renumbered this section as Sec.  112.147 as a consequential change from 
the addition of new Sec.  112.141.
    (Comment 379) Several comments support our proposed requirement to 
develop a written sampling plan and to test spent irrigation water or 
sprouts for E. coli O157:H7 and Salmonella. One comment states that 
testing of spent irrigation water should apply to ``green sprouts'' 
(e.g., alfalfa, clover) only, and that mung bean sprouts should be 
exempt from this requirement. According to this commenter, mung bean 
sprouts are periodically irrigated with large volumes of water (i.e., 
200 gallons per growing container) and it would be difficult to collect 
and analyze a meaningfully representative sample of spent irrigation 
water during mung bean sprout production.
    (Response) Sampling spent sprout irrigation water or sprouts is an 
important testing procedure to ensure contaminated product does not 
enter commerce, and, therefore, we are retaining the provisions in 
proposed Sec.  112.146 as renumbered Sec.  112.147 with certain 
revisions, as explained in the paragraphs that follow. We expect the 
written sampling plan to be developed taking into account the farm's 
specific growing and irrigation practices so the samples collected and 
tested are representative of the farm's spent sprout irrigation water 
or sprouts. For example, in some situations, a sprout farm may want to 
temporarily adjust the volume of water that flows through a growing 
unit for the purposes of collecting spent irrigation water samples. 
With regard to mung bean sprout production, research has shown that 
testing spent irrigation water of sprouting mung bean beds can provide 
a useful assessment of its microbiological status, and we disagree that 
mung bean sprouts should be exempt from the requirements of Sec.  
112.147 in light of certain irrigation practices (Ref. 227). One means 
to comply with Sec.  112.147(b) is to follow the recommendations in the 
Sprouts Testing Guide (Ref. 97).
    We are revising Sec.  112.147(b) to reflect the new provisions in 
Sec.  112.144(b) and (c) for testing for additional pathogens when the 
criteria in the rule are met. Thus, we are revising the introductory 
text in Sec.  112.147 to refer to testing ``for pathogens as required 
in Sec.  112.114(b)'' and revising Sec.  112.147(b) to refer not to 
testing for E. coli O157:H7 and Salmonella spp., but instead generally 
to ``pathogens,'' by which we mean those pathogen tests required by 
Sec.  112.144(b) and (c). We are also revising Sec.  112.147(b) to 
require testing using a method as set forth in new Sec.  112.153 (see 
discussion in section XIX.B of this document).
    As we previously noted in Comment 369, testing of spent sprout 
irrigation water or sprouts is a process control as well as a 
verification step. Accordingly, we have added text in Sec.  112.147(b) 
to require that you must not allow the production batch of sprouts to 
enter commerce unless the results of the

[[Page 74506]]

testing of spent sprout irrigation water or sprouts are negative for E. 
coli O157:H7, Salmonella spp., and, if applicable, a pathogen meeting 
the criteria in Sec.  112.144(c). This is consistent with the 
requirement in Sec.  112.148(a) that, if samples of spent sprout 
irrigation water or sprouts are positive for E. coli O157:H7, 
Salmonella spp., or a pathogen meeting the criteria in Sec.  
112.144(c), you must take appropriate action to prevent any food that 
is adulterated under section 402 of the FD&C Act from entering 
commerce. The requirement to not allow sprouts to enter into commerce 
until pathogen testing results are negative is consistent with current 
industry best practices (Ref. 219).
    In addition, as in Sec.  112.145 for environmental testing 
(discussed in Comment 378), we are adding a requirement that your 
written sampling plan for spent sprout irrigation water testing (or 
sprout testing) include a corrective action plan that at a minimum, 
requires you to take the actions in Sec.  112.148, and details when and 
how you will accomplish those actions, if the samples of spent sprout 
irrigation water or sprouts test positive for E. coli O157:H7, 
Salmonella spp., or a pathogen meeting the criteria in Sec.  112.144(c) 
(see Sec.  112.147(c)). Establishing and implementing a written 
corrective action plan will help ensure that corrective actions are 
taken quickly in response to positive findings of pathogens in spent 
irrigation water or sprouts. This requires you to consider the likely 
scenarios in advance, developed through review of appropriate sprout 
safety resources, rather than react to these scenarios on an ad hoc 
basis. The requirement to have a written plan is consistent with other 
FDA food safety regulations, such as our juice and seafood HACCP 
regulations.

H. Actions if Spent Sprout Irrigation Water or Sprouts Test Positive 
for a Pathogen (Sec.  112.148)

    (Comment 380) Several comments state that FDA should establish the 
steps that sprouters must take on a finished batch or lot of sprouts 
found to be contaminated through the testing requirements of this 
subpart. One comment states that FDA should require the immediate 
destruction or disposal of any finished product that may be 
adulterated, as indicated by a positive finding in the tests required 
under proposed Sec.  112.146.
    (Response) In light of these comments, we are establishing new 
Sec.  112.148 to require sprout operations to take certain actions if 
the samples of spent sprout irrigation water or sprouts test positive 
for E. coli O157:H7, Salmonella spp., or a pathogen meeting the 
criteria in Sec.  112.144(c). In part, Sec.  112.148 requires you to 
take appropriate action to ensure that adulterated food does not enter 
commerce (see Sec.  112.148(a)).
    Testing of spent sprout irrigation water or sprouts for Salmonella 
spp., E. coli O157:H7, or a pathogen meeting the criteria in Sec.  
112.144(c) is required under Sec.  112.144(b). A production batch of 
sprouts for which any of these pathogens is detected in the spent 
sprout irrigation water is 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. Similarly, a production batch of sprouts for which 
any of these pathogens is detected in the sprouts is 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 
them injurious to health. In such a circumstance, the covered farm must 
take appropriate steps to ensure that the adulterated food does not 
enter commerce, including, as appropriate, destroying or diverting the 
product to non-food use.
    In addition, new Sec.  112.148(b) requires you to take the steps 
required in Sec.  112.142(b) with respect to the lot of seeds or beans 
used to grow the affected production batch of sprouts (except as 
allowed under Sec.  112.142(c)). This provision is intended to make 
clear that the requirements in Sec.  112.142(b) relating to seeds or 
beans apply to all situations in which your required testing of spent 
irrigation water or sprouts results in a positive pathogen finding, 
except as otherwise provided in section Sec.  112.142(c). For a 
detailed discussion of these requirements, see section XVIII.B of this 
document.
    In addition, Sec.  112.148(c) requires you to clean and sanitize 
the affected surfaces and surrounding areas. This provision is 
consistent with our recommendations in the Sprouts Testing Guide. 
Anything in the sprouting operation that has come into contact with the 
contaminated production batch or its water (e.g., drums, trays, bins, 
buckets, tools and other sprouting equipment, testing equipment, and 
other possible surfaces, such as floors, drains, walls, and tables), 
must be thoroughly cleaned and sanitized to avoid contamination of 
subsequent batches of sprouts (Ref. 97).
    Finally, Sec.  112.148(d) requires you to perform any other actions 
necessary to prevent reoccurrence of the contamination. For example, a 
sprout grower may consider re-evaluating their seed treatment protocol, 
consider switching their seed supplier, or consider switching to using 
seeds that have been grown under Good Agricultural Practices and 
conditioned, handled and stored under sanitary conditions.

I. Records Related to Sprouts (Sec.  112.150)

    We are making conforming changes to this section to reflect 
renumbering and revisions to other provisions in this subpart. In 
addition, we note that while we have added requirements for covered 
sprout farms to establish corrective action plans, such plans are 
required as part of the written environmental monitoring plan already 
required under Sec.  112.145 and the written sampling plan for each 
production batch of sprouts already required under Sec.  112.147. Thus, 
we are not revising Sec.  112.150 to add separate records requirements 
for these corrective action plans because they are already covered in 
Sec.  112.150(b)(2) (written environmental monitoring plans) and Sec.  
112.150(b)(3) (written sampling plans for each production batch of 
sprouts). We are also adding new requirement in final Sec.  
112.150(b)(6), discussed further in Comment 381.
    (Comment 381) Several comments state that the recordkeeping 
requirements should be expanded to include documentation of any 
corrective actions that farms employ to address problems identified and 
verification that those corrective actions were effective.
    (Response) In proposed Sec.  112.161(b), we proposed a general 
provision applicable to records are required under subparts C, E, F, L, 
and M of part 112 that you must establish and keep documentation of 
actions you take when a standard in any of these subparts is not met. 
For clarification, we are eliminating proposed Sec.  112.161(b) and, 
instead, adding that requirement within the records provisions of two 
relevant subparts, including subpart M. As revised, under Sec.  
112.150(b)(6), you must establish and keep documentation of actions you 
take in accordance with Sec. Sec.  112.142(b) and (c), 112.146, and 
112.148. This requires covered sprout farms to keep documentation of 
actions taken related to seeds and beans that may be contaminated, in 
accordance with Sec.  112.142(b) and (c), and corrective actions in 
accordance with Sec. Sec.  112.146 or 112.148. For example, if your 
testing required under Sec.  112.144(a) indicates a detection of 
Listeria spp. or L. monocytogenes in the growing, harvesting, packing, 
or holding

[[Page 74507]]

environment, this provision requires you to establish and keep a record 
of the corrective steps that you took in response to that positive 
finding in compliance with Sec.  112.146.
    In addition, in final Sec.  112.150(b)(5), we are requiring records 
of any analytical methods you use in lieu of the methods that are 
incorporated by reference in new Sec.  112.153 (see section XIX.B of 
this document). This requirement is consistent with proposed Sec.  
112.150(b)(5), in which we proposed to require records of any 
analytical methods you use in lieu of the methods that are incorporated 
by reference in Sec.  112.152, which we have retained in final Sec.  
112.150(b)(5). That is, in final Sec.  112.150(b)(5), we require 
records of any analytical methods you use in lieu of the methods that 
are incorporated by reference in Sec. Sec.  112.152 and 112.153. In 
addition, we are eliminating proposed Sec.  112.150(b)(6) as a 
corresponding change.
    We are also revising proposed Sec.  112.150(b)(4) to clarify that 
documentation of the results of all analytical tests conducted for 
purposes of compliance with subpart M is required. This revision is 
consistent with the records requirement for agricultural water in Sec.  
112.50(b)(2).

J. Compliance Periods for Covered Activities Involving Sprouts

    (Comment 382) Some comments request clarification regarding 
coverage of sprout operations under part 112 and the applicability of 
the provisions of part 112 (other than subpart M) to sprout operations. 
Some comments request clarification on whether all sprout farms will be 
subject to part 112 in addition to proposed subpart M, and whether 
sprout farms may also be eligible for a qualified exemption or extended 
compliance periods based on the farm's size. Citing the high risk 
nature of sprout production, one commenter argues that sprout farms 
should not be eligible for the qualified exemption or extended 
compliance periods. Some comments specifically asked us to shorten the 
compliance periods for sprouts to protect public health.
    (Response) As described throughout the 2013 proposed rule and in 
this rule, part 112 establishes the minimum science-based standards 
that we determine to minimize the risk of serious adverse health 
consequences or death, including procedures, processes, and practices 
that we determine to be reasonably necessary to prevent the 
introduction of known or reasonably foreseeable hazards into fruits and 
vegetables, and to provide reasonable assurances that the produce is 
not adulterated. Sprouts are produce (see definition of ``produce'' in 
Sec.  112.3) and, therefore, sprout farms are subject to all of part 
112, as applicable. In addition, as discussed in the 2013 proposed rule 
(78 FR 3504 at 3594), because sprouts present a special concern with 
respect to human pathogens compared to other covered produce due to the 
warm, moist, and nutrient-rich conditions required to produce sprouts, 
we have incorporated the additional standards in subpart M specifically 
targeted to sprout operations. Accordingly, covered sprout farms are 
subject to all applicable requirements of part 112, including the 
specific requirements of subpart M.
    The threshold for coverage (under Sec.  112.4(a)) and the qualified 
exemption and associated modified requirements (under Sec. Sec.  
112.4(b) and 112.5-112.7) all apply to sprout farms.
    With regard to compliance dates for covered activities involving 
sprouts, we agree that our proposed compliance dates were not 
sufficiently protective of public health. There is a long history of 
food safety problems associated with sprouts (78 FR 3504 at 3594-3601) 
and, therefore, we agree that we should establish shorter compliance 
periods for sprouts as compared to other covered produce. Section 
419(a)(4) of the FD&C Act provides that we shall prioritize the 
implementation of this rule for specific fruits and vegetables based on 
known risks which may include a history and severity of foodborne 
illness outbreaks. We believe it is appropriate to expedite the 
implementation of the provisions of part 112, including subpart M, for 
covered activities involving sprouts, based in part on the history and 
severity of sprout-related foodborne illness outbreaks, to reduce the 
likelihood of future sprout-related outbreaks.
    We also believe it is not necessary to give sprout farms extra time 
to comply with the certain water provisions of subpart E as we are 
doing with respect to other commodities (see section XIII.K of this 
document). Based on information available to us, we believe that most, 
if not all, sprout farms already use public water supplies and/or 
ground water sources for all relevant purposes subject to the microbial 
quality criterion in Sec.  112.44(a) (Ref. 245). The other provisions 
in subpart E for which we are allowing extended compliance dates for 
other commodities are either (1) directly linked to compliance with the 
microbial quality criterion in Sec.  112.44(a); or (2) are not relevant 
to sprouts (i.e., the criteria in Sec.  112.44(b) are only for produce 
other than sprouts).
    Therefore, for covered activities involving sprouts, we are 
establishing that businesses other than small and very small businesses 
would have one year after the effective date of the final rule to 
comply with all of the provisions of this rule, whereas small 
businesses would have two years and very small businesses would have 
three years to comply with all of the provisions of this rule. This is 
consistent with the requirements in section 419(b)(3) of the FD&C Act 
that this rule 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. See also XXIV of this document for additional 
information.

K. Other Comments

    (Comment 383) One comment recommends that FDA require a food safety 
plan, and that this plan should also include a sprout-specific section.
    (Response) As explained in section VII of this document, although 
we are not establishing a general requirement for covered farms to 
conduct an operational assessment or develop and implement a food 
safety plan, we encourage all farms to do so because food safety plans 
can help a farm to be more effective in ensuring the safety of produce 
grown, harvested, packed, or held at that farm.
    (Comment 384) One comment asks us to consider establishing audit 
and inspection requirements specific to the sprout industry, and to 
provide appropriate training to auditors and inspectors. This commenter 
also suggests that FDA should require GFSI audits and unannounced 
inspections of sprout operations to verify best practices and food 
safety and quality standards.
    (Response) We are not establishing requirements in this rule for 
audits of covered farms, generally, or of sprout farms, specifically. 
We do not see a reason to impose audit requirements specific to sprout 
farms in this rule. However, we recognize the role that third-party 
audits can play in promoting food safety. In the final human preventive 
controls rule (80 FR 55908) and the final FSVP rule (published 
elsewhere in this issue of the Federal Register), we are establishing 
certain supplier verification requirements that we expect to play a 
role in achieving compliance with this rule. In addition, we note that 
in the final third-party certification rule (published elsewhere in 
this issue of the Federal Register), FDA is establishing a voluntary 
program for the accreditation of third-party certification bodies that 
may conduct audits and issue certifications for purposes of 
establishing an entity's

[[Page 74508]]

eligibility to participate in the Voluntary Qualified Importer Program 
(VQIP) or to satisfy conditions set forth under section 801(q) of the 
FD&C Act.
    We are also working with our partners to develop sprout-specific 
training, including training for use by inspectors. See section XXII of 
this document where we discuss our strategy for the implementation of 
the produce safety regulation, including the role of our federal, 
State, local, territorial, and tribal partners as well as private 
entities.

XIX. Subpart N--Comments on Analytical Methods

    In subpart N of proposed part 112, we proposed methods of analysis 
for testing the quality of agricultural water and the growing 
environment for sprouts, as required under proposed subparts E and M, 
respectively. We asked for comment on our proposed provisions in 
subpart N, including specific methods and an allowance for alternative 
methods to be used provided they are at least equivalent to the 
proposed methods in accuracy, precision, and sensitivity.
    We are finalizing these provisions with revisions (see Table 25). 
We discuss these changes in this section.

             Table 25--Description of Revisions to Subpart N
------------------------------------------------------------------------
       Final provision                  Description of revisions
------------------------------------------------------------------------
Sec.   112.151...............  --Revision to eliminate the Official
                                Methods of Analysis of the AOAC
                                International, the Standard Methods for
                                the Examination of Water and Wastewater
                                of the American Public Health
                                Association, and the FDA's
                                Bacteriological Analytical Manual from
                                the list of specified methods.
                               --Revision to specify as the prescribed
                                method of analysis, and to incorporate
                                by reference, Method 1603 published by
                                EPA.
                               --Revision to clarify that methods used
                                other than that specifically
                                incorporated must be scientifically
                                valid.
                               --Revision to indicate that methods used
                                for other indicators of fecal
                                contamination must be scientifically
                                valid.
                               --Editorial revision, moving ``a method
                                of analysis'' into subparagraphs.
                               --Conforming revision to change cross-
                                reference in title to Sec.   112.46.
Sec.   112.152...............  --Revision to incorporate by reference a
                                specific method that is based on methods
                                and procedures described in FDA's
                                Bacteriological Analytical Manual (BAM),
                                USDA's Microbiology Laboratory
                                Guidebook, and those used in FDA's
                                compliance activities (in lieu of
                                specifying a chapter of FDA's BAM)
                                Revision to the locations where a copy
                                of the specified method may be obtained
                                or inspected.
                               --Revision to clarify that methods used
                                other than that specifically
                                incorporated must be scientifically
                                valid.
                               --Editorial revision to shorten
                                introductory text by removing
                                duplicative phrase ``by testing'' and
                                unnecessary reference to ``in
                                environmental samples''.
                               --Conforming revision to change cross-
                                reference in title to Sec.   112.144(a),
                                and to add ``harvesting, packing, and
                                holding'' to title and introductory
                                text.
Sec.   112.153...............  --New section to: (1) Prescribe a method
                                of analysis for testing spent sprout
                                irrigation water (or sprouts) from each
                                production batch of sprouts for E. coli
                                O157:H7 and Salmonella to satisfy the
                                requirements of Sec.   112.144(b), and
                                to provide flexibility for use of other
                                scientifically valid methods (see Sec.
                                112.153(a)) and (2) specify that a
                                scientifically valid method must be used
                                for any other pathogens meeting the
                                criteria in Sec.   112.144(c) (see Sec.
                                 112.153(b)).
------------------------------------------------------------------------

A. Responses to Comments

    (Comment 385) One comment suggests revising proposed Sec.  
112.151(a)(1) to cite the 19th edition of the Official Methods of 
Analysis published by AOAC INTERNATIONAL in 2012, rather than the 18th 
edition that was issued in 2011.
    (Response) We are revising final Sec.  112.151 to eliminate the 
method of analysis, as published in the Official Methods of Analysis of 
AOAC International, as a prescribed method for testing the quality of 
water to satisfy the requirements of Sec.  112.46. See section XIX.B of 
this document.
    (Comment 386) Some comments seek clarification on the allowance for 
use of equivalent methods. One comment asks whether FDA would review a 
method to determine its equivalency to the relevant specified 
method(s), and requests clarification on how such equivalency should be 
determined. In addition, another comment suggests FDA should consider 
EPA-approved test methods for water acceptable for purposes of testing 
the quality of water required under this rule.
    (Response) We have specified in subpart N certain analytical 
methods for use to satisfy the testing requirements related to 
agricultural water and sprouts. We reviewed EPA-approved test methods 
for water, and determined that Method 1603, an EPA-approved test method 
identified in 40 CFR 136.3, Table IH, is appropriate for testing water 
quality to satisfy the requirements of Sec.  112.46 (see section XIX.B 
of this document).
    However, we recognize that other scientifically valid methods, 
particularly test kits, may be available or may become available in the 
future. Therefore, we provide flexibility for covered farms to use any 
other scientifically valid method that is at least equivalent to a 
prescribed analytical method in accuracy, precision, and sensitivity. 
See also Comment 9. We are clarifying in Sec. Sec.  112.151(b), 
112.152(b), and 112.153(a)(2) and (b) that such methods must be 
scientifically valid. As noted in response to Comment 26, the term 
``scientifically valid'' means an approach that is based on scientific 
information, data, or results published in, for example, scientific 
journals, references, text books, or proprietary research. Any 
scientifically valid method can be used provided you ensure that the 
method is at least equivalent to the applicable prescribed analytical 
method in accuracy, sensitivity, and precision in detecting the 
relevant organism or indicator (e.g., generic E. coli, Salmonella, L. 
monocytogenes, or Listeria spp.) in the relevant sample matrix (e.g., 
ground water, surface water, environmental swabs, spent sprout 
irrigation water, or sprouts). We are not further requiring covered 
farms to notify or submit information about such methods of analysis 
for FDA's review or approval prior to use, nor do we believe that such 
a requirement is warranted. We intend to disseminate useful scientific 
information, when available, including on any new scientifically valid 
methods of analysis at least equivalent in accuracy, precision, and 
sensitivity to our prescribed methods.
    (Comment 387) Another comment states that if samples are not 
collected in a sanitary manner there is no

[[Page 74509]]

guarantee that the results will be scientifically valid.
    (Response) We agree aseptic collection of samples is important, and 
have added this requirement under Sec. Sec.  112.47(b) and 112.145(d). 
In addition, we have retained the requirement to collect samples 
aseptically, as previously proposed, in renumbered Sec.  112.147(b). 
See also Comment 233 and Comment 376.

B. Other Revisions

    With respect to the prescribed methods for testing agricultural 
water, we are eliminating proposed Sec. Sec.  112.151(a)(1), 
112.151(a)(2), and 112.151(a)(3). On further review, we find the 
testing methods specified in proposed Sec.  112.151(a)(1) to (3) 
inadequate for the purpose of testing the quality of water to satisfy 
the requirements of Sec.  112.46. The methods of analysis in the 
Official Methods of Analysis of AOAC INTERNATIONAL and the Standard 
Methods for the Examination of Water and Wastewater specified in 
proposed Sec. Sec.  112.151(a)(1) and 112.151(a)(2), respectively, are 
not intended to capture discrete concentrations of microbial 
populations in sources of water that may be turbid or whose microbial 
quality may potentially vary irregularly. Likewise, the FDA's 
Bacteriological Analytical Manual (BAM) method specified in proposed 
Sec.  112.151(a)(3) covers examination of bottled water only and does 
not explicitly address testing of agricultural water. Instead, for 
analysis of environmental water, the FDA's BAM method refers to EPA-
approved test methods, which we have reviewed and we are specifying 
EPA's Method 1603 as a prescribed method in final Sec.  112.151(a). We 
are also adding Sec.  112.151(b)(2) to clarify that if you use an 
alternative indicator of fecal contamination in accordance with Sec.  
112.49(a) you must use a scientifically valid method to test for the 
indicator.
    With respect to the prescribed methods for testing the sprout 
growing, harvesting, packing, and holding environment for Listeria spp. 
or L. monocytogenes, we are retaining proposed Sec.  112.152 with 
revisions. Under final Sec.  112.152(a), we are prescribing the 
relevant method, i.e., FDA's method of analysis described in ``Testing 
Methodology for Listeria species or L. monocytogenes in Environmental 
Samples,'' October, 2015, rather than prescribing a particular chapter 
of FDA's BAM (as in proposed Sec.  112.152). On further review, we find 
the method that is described in the particular chapter of FDA's BAM 
(cited in proposed Sec.  112.152) has been validated for detection of 
Listeria spp. or L. monocytogenes primarily in food samples. For the 
purposes of testing environmental samples for detection of Listeria 
spp. or L. monocytogenes to satisfy the requirements of 112.144(a), we 
are incorporating by reference a method that is based on the methods 
and procedures in USDA's Microbiology Laboratory Guidebook, FDA's BAM, 
and those used in FDA's compliance activities. In addition, consistent 
with Sec.  112.151(b)(1), under Sec.  112.152(b), we are retaining the 
proposed flexibility for the use of other method(s) in lieu of the 
prescribed methods of analysis, provided the other method is 
scientifically valid and is at least equivalent in accuracy, 
sensitivity, and precision to the method in Sec.  112.152(a). We 
believe these changes in final Sec.  112.152 are necessary to prescribe 
the appropriate testing methods, while retaining flexibility for use of 
other scientifically valid methods, to meet our testing requirements in 
Sec.  112.144(a).
    We are revising both proposed Sec. Sec.  112.151 and 112.152 to 
provide current information about the location where you may obtain or 
inspect a copy of the prescribed methods. We are also making certain 
conforming changes in these sections to update the cross-references to 
other provisions. We are also making certain non-substantive editorial 
changes in these sections (moving the phrase ``a method of analysis'' 
in Sec.  112.151, and shortening the introductory text in Sec.  112.152 
by removing the duplicative phrase ``by testing'' and an unnecessary 
reference to ``in environmental samples'').
    We are adding new Sec.  112.153 to specify certain methods of 
analysis for testing spent sprout irrigation water (or sprouts) from 
each production batch of sprouts, which is required under Sec.  
112.144(b). We are specifying that you must test for E. coli O157:H7 
and Salmonella spp. using FDA's method of analysis described in 
``Testing Methodologies for E. coli O157:H7 and Salmonella species in 
Spent Sprout Irrigation Water (or Sprouts),'' October, 2015 (Sec.  
112.153(a)(1)); or using a scientifically valid alternative method 
(Sec.  112.153(a)(2)). The method described in Sec.  112.153(a)(1) is 
based on the method described in the current edition of FDA's BAM with 
additional details for testing spent irrigation water or sprouts, and 
we are incorporating by reference this particular method into part 112 
for the purposes of testing required under Sec.  112.144(b). In Sec.  
112.153(a)(2), consistent with Sec. Sec.  112.151(b)(1) and 112.152(b), 
we are providing flexibility for the use of an alternative method(s) 
for E. coli O157:H7 or Salmonella spp., in lieu of the prescribed 
method of analysis, provided the alternative method is scientifically 
valid and is at least equivalent in accuracy, sensitivity, and 
precision to the method in Sec.  112.153(a)(1). In addition, Sec.  
112.153(b) specifies that a scientifically valid method must be used to 
test spent sprout irrigation water (or sprouts) from each production 
batch of sprouts for any other pathogen(s) that meet the criteria in 
Sec.  112.144(c). By prescribing the method of analysis and 
incorporating sufficient flexibility for the use of scientifically 
valid alternative methods, we expect new Sec.  112.153 to help covered 
farms meet our testing requirements in Sec.  112.144(b).

C. Incorporation by Reference

    In Sec.  112.152(a), FDA is incorporating by reference ``Testing 
Methodology for Listeria species or L. monocytogenes in Environmental 
Samples,'' Version 1, dated October 2015, U.S. Food and Drug 
Administration and, in Sec.  112.153(a)(1), FDA is incorporating by 
reference ``Testing Methodologies for E. coli O157:H7 and Salmonella 
species in Spent Sprout Irrigation Water (or Sprouts),'' Version 1, 
dated October 2015, U.S. Food and Drug Administration, which was 
approved by the Office of the Federal Register. You may obtain a free 
copy of the material from the Division of Produce Safety, Center for 
Food Safety and Applied Nutrition, U.S. Food and Drug Administration, 
5100 Paint Branch Pkwy., College Park, MD 20740, 240-402-1600; the 
Docket at www.regulations.gov; or from the Food and Drug 
Administration, at FDA's Main Library, 10903 New Hampshire Ave., Bldg. 
2, Third Floor, Silver Spring, MD 20993, 301-796-2039. These methods 
are related to the detection of pathogens in the production of sprouts. 
We are specifying the prescribed method for testing of the sprout 
production environment for Listeria in accordance with Sec.  
112.144(a). This is an enrichment method for the detection of Listeria 
spp. in the environment of sprout farms and the confirmation of the 
presence of L. monocytogenes in samples that are positive for Listeria 
spp. We are also specifying the prescribed method for testing of spent 
sprout irrigation water or sprouts for two pathogens in accordance with 
Sec.  112.144(b). This method includes: (1) Screening procedures by 
real-time PCR to establish the presumptive presence of E. coli O157:H7, 
followed by culture confirmation of E. coli O157:H7, and (2) screening 
procedures to detect a presumptive positive for the presence of

[[Page 74510]]

Salmonella spp., followed by confirmation of the presence of Salmonella 
spp. by a variety of confirmatory tests. We are specifying these 
prescribed methods, while also providing the flexibility for use of 
other scientifically valid methods, to help covered farms to meet our 
testing requirements in Sec.  112.144.
    In Sec.  112.151(a), FDA is incorporating by reference ``Method 
1603: Escherichia coli (E. coli) in Water by Membrane Filtration Using 
Modified membrane-Thermotolerant Escherichia coli Agar (Modified 
mTEC),'' dated December 2009, U.S. Environmental Protection Agency 
(EPA), EPA-821-R-09-007, which was approved by the Office of the 
Federal Register. You may obtain a free copy of the material from EPA, 
Office of Water (4303T), 1200 Pennsylvania Avenue NW., Washington, DC 
20460. 202-564-6620; http://water.epa.gov/scitech/methods/cwa/bioindicators/upload/method_1603.pdf; the Docket at 
www.regulations.gov; or from the Food and Drug Administration, at FDA's 
Main Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver 
Spring, MD 20993, 301-796-2039. This method is an EPA-approved 
analytical test method. It provides the procedures for testing 
agricultural water samples to determine the microbial quality of water 
to satisfy the requirements of Sec.  112.46. We are specifying this 
prescribed method, while also providing the flexibility for use of 
other scientifically valid methods, to help covered farms to meet our 
testing requirements in Sec.  112.46.

XX. Subpart O--Comments on Records

    In subpart O of proposed part 112, we proposed requirements that 
would be applicable to all records required by part 112. We tentatively 
concluded 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. We asked for comment on our proposed 
provisions.
    We are finalizing these provisions with revisions (see Table 26). 
We discuss these changes in this section. Some comments support one or 
more of the proposed provisions without change. We discuss the comments 
that ask us to clarify the proposed requirements or that disagree with, 
or suggest one or more changes to, the proposed requirements. For Sec.  
112.166, we did not receive any comments or received only general 
comments in support of the proposed provision and, therefore, we do not 
specifically discuss these provisions.

             Table 26--Description of Revisions to Subpart O
------------------------------------------------------------------------
       Final provision                  Description of revisions
------------------------------------------------------------------------
Sec.   112.161...............  --Revision to eliminate proposed Sec.
                                112.161(b) and, instead, add that
                                requirement within the records
                                provisions of the relevant subpart,
                                i.e., Sec.  Sec.   112.50(b)(6) and
                                112.150(b)(6).
                               --Renumber proposed Sec.   112.161(c) as
                                Sec.   112.161(b) and make conforming
                                edits to update cross references.
                               --Revision to add the phrase ``except as
                                otherwise specified'' in Sec.
                                112.161(a) to reflect that certain
                                records requirements specified in the
                                relevant subparts of part 112 include
                                requirements that are different from the
                                ones in subpart O.
                               --Revision to cover new provision Sec.
                                112.7 within renumbered Sec.
                                112.161(b).
Sec.   112.162...............  --Revision to remove ``after 6 months
                                following the date the record was made''
                                to allow immediate offsite storage of
                                records provided they can be retrieved
                                and provided onsite within 24 hours of
                                request for official review.
Sec.   112.163...............  --Revision to clarify types of existing
                                records that do not need to be
                                duplicated to comply with this part.
                               --Revision to clarify that such records
                                must satisfy the requirements of this
                                part.
                               --Revision to add ``Existing records may
                                be supplemented as necessary to include
                                all of the required information and
                                satisfy the requirements of this part
                                112''.
                               --Revision to clarify that the
                                information required by this part need
                                not be kept in one set of records, and
                                any new information required by this
                                part may be kept separately or combined
                                with existing records.
Sec.   112.164...............  --Revision to add new Sec.
                                112.164(a)(2) to specify that records
                                that a farm relies on during the 3-year
                                period preceding the applicable calendar
                                year to satisfy the criteria for a
                                qualified exemption must be retained as
                                long as necessary to support the farm's
                                status during the applicable calendar
                                year.
                               --Revision to Sec.   112.164(a)(1) to
                                replace ``2 years'' with ``at least 2
                                years'' so the length of record
                                retention in this provision is
                                harmonized with new Sec.
                                112.164(a)(2).
                               --Revision to Sec.   112.164(b) to
                                specify that ``records that relate to
                                analyses, sampling, or action plans
                                being used by a farm, including the
                                results of scientific studies, tests,
                                and evaluations'' must be retained for
                                at least two years after the use of such
                                records is discontinued.
Sec.   112.165...............  --Revision to establish that electronic
                                records maintained to satisfy this part
                                112 are exempt from the requirements of
                                part 11 of this chapter, except to the
                                extent that they are also required under
                                other applicable statutory provisions or
                                regulations and are therefore subject to
                                part 11.
Sec.   112.167...............  --Revision to clarify that records
                                ``obtained by FDA in accordance with
                                this part'' are subject to the
                                disclosure requirements under part 20.
------------------------------------------------------------------------

A. General Comments

    (Comment 388) Several comments express support for our proposed 
approach to limit recordkeeping requirements. These commenters state 
that records of required monitoring activities and corrective actions 
are sufficient for FDA to evaluate an operation's level of compliance 
with the requirements of the rule. Conversely, one commenter recommends 
that fruits and vegetables with little or no associated risk of 
foodborne illness should have a lower recordkeeping burden, whereas 
another commenter, while not providing specific suggestions, urges us 
to reduce the recordkeeping requirements to a minimum.
    (Response) The recordkeeping requirements in this rule are limited 
to those specific instances where: (1) Maintenance of detailed 
information is needed to keep track of measures directed at minimizing 
the risk of known or reasonably foreseeable hazards; (2) identification 
of a pattern of problems is important to minimizing the risk of such 
hazards; and (3) records are

[[Page 74511]]

important to facilitate verification and compliance with standards and 
such verification and compliance cannot be effectively done by means 
other than a review of relevant records. Therefore, we believe that the 
requirements for developing and maintaining records established in part 
112 are the minimum necessary.
    With respect to the comment about establishing different 
recordkeeping requirements for different commodities based on their 
associated risk of foodborne illness, we refer you to the discussion in 
section IV of this document, in which we explain our rationale for 
relying on an integrated regulatory approach that focuses on practices, 
processes, and procedures and the potential for contamination through 
common on-farm routes, rather than on a commodity-specific regulatory 
framework. The recordkeeping requirements in this rule stem from our 
integrated regulatory approach.
    (Comment 389) Several comments state that recordkeeping may cause 
financial hardship, such as lost time and revenue, for small- to mid-
size farms.
    (Response) As we discussed in sections IV.E and V.O of the 2013 
proposed rule, in determining the 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 appreciate the concerns with respect to cost and burden to farms 
and, to the extent possible, we have established documentation 
requirements that are risk-based and capable of being tailored to an 
individual farm, taking into account the unique characteristics of the 
operation, the commodities handled, and the operation's growing, 
harvesting, packing, and holding procedures. The recordkeeping 
requirements in subpart O of part 112 allow the use of existing 
records, provided such records satisfy all of the applicable 
requirements of part 112 (see Sec.  112.163). We are further clarifying 
in this final rule that you are not required to keep all of the 
information required by part 112 in one set of records. In addition, 
per Sec.  112.165, electronic records are acceptable, although not 
required. Records in forms as diverse as hard copies of handwritten 
logs, invoices, and documents reporting laboratory results are also 
acceptable, provided they are indelible and legible. We estimated the 
costs associated with our recordkeeping requirements (Ref. 142).
    (Comment 390) A few comments request that we more clearly define 
the records that must be kept and the content of such records. One of 
these comments asks whether FDA will provide training, including 
specific forms, templates or checklists, for farmers to comply with the 
records requirements.
    (Response) The records required under this regulation are 
dependent, in part, on the nature of practices and procedures related 
to the covered activities in your operation, and are listed under the 
applicable sections of part 112, including in subparts A, C, E, F, L, 
and M (i.e., Sec. Sec.  112.2(b)(4), 112.7, 112.30, 112.50, 112.60, 
112.140, and 112.150). We will consider providing guidance on the 
required records and their content, as needed. We also expect that the 
training curriculum and materials being developed by the PSA will 
address recordkeeping, and the SSA intends to provide ``model'' forms 
and training for sprout farmers on how to develop and maintain 
appropriate records.
    (Comment 391) One comment suggests that records related to safety, 
including testing reports, should appear as part of labeling that 
accompanies produce as the commodity moves through the food chain. This 
commenter also asks us to make labels an active component of the food 
safety system instead of establishing the recordkeeping requirements we 
proposed.
    (Response) Documentation of some practices is critical to ensure 
that this rule is adequately implemented on the farm. Records are 
useful for keeping track of detailed information over a period of time, 
and can identify patterns of problems and, thus, enable a farm to find 
and correct the source of problems. Records are also useful during FDA 
inspections for investigators to determine compliance with relevant 
requirements of the rule. We are not establishing new labeling 
requirements in this rule other than as set forth in Sec.  112.6(b) for 
farms eligible for the qualified exemption and Sec.  112.2(b) for 
produce eligible for the commercial processing exemption. We do not 
agree that product labels or labeling should be used as a substitute 
for the recordkeeping requirements in subpart O of part 112. Produce 
commodities, in packaged form, are subject to certain labeling 
requirements specified in 21 CFR part 100; however, such requirements 
are outside the scope of this rule.

B. General Requirements Applicable to Records Required Under Part 112 
(Sec.  112.161)

    (Comment 392) Stating that on-farm records are often recorded in 
pencil, one comment expresses concern that, under the proposed 
requirements of Sec.  112.161, records would have to be recorded in 
ink. This commenter states that outdoor on-farm environmental 
conditions often dictate the use of pencils instead of pens because 
rain can cause smearing of ink-recorded paperwork.
    (Response) This comment appears to be in response to the 
requirement in Sec.  112.161(a)(3) that records must be, among other 
things, indelible. We believe it is important for records to be 
indelible, and are retaining this requirement, as proposed. If a 
covered farm were to prepare the required record in pencil, we could 
not be confident that the record had not been altered from its original 
content. In addition, we do not believe the requirement is impractical 
for farms because we understand that a number of products such as all-
weather and ballpoint pens are available that can write on wet paper 
and also do not cause smearing. This requirement is consistent with the 
provisions of the PCHF regulation and we are finalizing it as proposed.
    (Comment 393) Some comments express support for proposed Sec.  
112.161(c) requiring a supervisor or responsible party to review 
certain records. Another comment recommends that allowances be made for 
a situation where the person who is responsible for the initial record 
is the owner or supervisor, in which case he or she should also be 
allowed to document the review of the records.
    (Response) We are making some changes by eliminating proposed Sec.  
112.161(b) and, instead, adding that requirement (as necessary) within 
the records provisions of the relevant subparts. Rather than a general 
requirement for documentation of actions you take when a requirement 
subparts C, E, F, L, or M is not met, we are limiting this requirement 
as compared to that in the 2013 proposed rule, and making our intent 
clear by specifying the corrective measures in relation to which your 
actions must be recorded and such records retained. As revised, under 
final Sec. Sec.  112.50(b)(6) and 112.150(b)(6), you must establish and 
keep documentation of actions you take in accordance with certain 
specified corrective measures established in

[[Page 74512]]

subparts E and M, respectively. We do not see the need for a similar 
documentation requirement in subparts C or L because we are not 
establishing specific corrective measures in relation to requirements 
in those subparts. Subpart F, too, does not include specific corrective 
measures for which additional documentation requirements (beyond the 
provisions we are finalizing, as discussed in section XIV.H of this 
document) are necessary. Therefore, we are not adding additional 
documentation requirements in Sec. Sec.  112.30, 112.60, or 112.140 
solely as a result of eliminating proposed Sec.  112.161(b). With the 
elimination of proposed Sec.  112.161(b), we have renumbered proposed 
Sec.  112.161(c) as Sec.  112.161(b), and we have also made conforming 
edits to update the cross-references in the provision that is now Sec.  
112.161(b).
    Regardless of who creates or prepares the initial documentation, if 
the record is one that is required under Sec. Sec.  112.7(b), 
112.30(b)(2), 112.50(b)(2), 112.50(b)(4), 112.50(b)(6), 112.60(b)(2), 
112.140(b)(1), 112.140(b)(2), 112.150(b)(1), 112.150(b)(4), or 
112.150(b)(6), it must be reviewed, dated, and signed by a supervisor 
or responsible party. This includes the records being required under 
new Sec.  112.7(b) (see Comment 139). In addition, in accordance with 
Sec.  112.161(a)(4), applicable records must be dated, and signed or 
initialed by the person who performed the activity that is documented. 
Where the owner or supervisor is both the person who performed the 
activity as well as the responsible party, by signing and dating the 
record, the owner or supervisor will have satisfied the requirements in 
both Sec. Sec.  112.161(a)(4) and 112.161(b).
    We have also revised Sec.  112.161(a) to add ``except as otherwise 
specified'' to reflect the fact that certain records requirements 
specified in relevant subparts of part 112 include requirements that 
are different from the ones in subpart O (e.g., Sec.  112.7(a), 
providing that we are not requiring sales receipts kept in the normal 
course of business to be signed or initialed by the person who 
performed the sale) (see Comment 139).

C. Storage of Records (Sec.  112.162)

    (Comment 394) Several comments express concern with our proposed 
provision Sec.  112.162(a) that would prohibit off-site storage of 
records for the first six months after a record is created. These 
comments find this provision to be unnecessarily burdensome, and argue 
that operations that move seasonally or that operate multiple growing 
sites should be able to retain records at an offsite location. These 
comments recommend revising this provision to read: ``Offsite storage 
of records is permitted if such records can be retrieved and provided 
onsite within 24 hours of request for official review.'' Another 
comment recommends also adding ``or a reasonable period of time'' as an 
alternative to help alleviate the burden.
    (Response) We understand the seasonal nature of certain farming 
operations and the fact that many farms have multiple growing sites 
that may not be contiguous. Proposed Sec.  112.162(a) would not require 
a farm with multiple growing sites to establish multiple records 
storage locations. Where multiple growing sites are operated under one 
management in one general (but not necessarily contiguous) physical 
location, they are part of one farm under our definition of farm (see 
Sec.  112.3(c)). We consider records to be on-site at a farm as long as 
they are located at a site on that farm (or in the case of electronic 
records, accessible from a site on that farm, see Sec.  112.162(b)). 
Thus, a farm's records would be considered to be on-site even if 
records related to field A are stored at field B, provided both fields 
are operated by the same farm under our definition. This allows a 
covered farm to store all of its records, including those records 
created during covered activities on seasonally-rented field(s) or in 
multiple growing locations, in the main offices of the farm's 
operation, for example, and does not require a single farm to set up a 
mechanism to store records related to each field separately at 
different locations. Nevertheless, we are revising Sec.  112.162(a) to 
permit offsite storage of required records provided such records can be 
retrieved and provided onsite within 24 hours of request for official 
review. Because the records will be available within 24 hours of an 
official request, and because we expect that a farm will also be able 
to retrieve and review all necessary records from its recent operations 
within a 24 hour period (allowing them to use the records to review 
detailed information needed to keep track of measures minimizing the 
risk of hazards, and identifying patterns of problems for the same 
purpose), we consider that this provision will satisfy the purposes of 
record retention. In order to maintain inspectional efficiency and to 
ensure that farms can use their own records as described previously, we 
are requiring that the time period between an FDA request for the 
records and their arrival not exceed 24 hours. Allowing for offsite 
storage of records under the conditions noted in Sec.  112.162(a) is 
consistent with our regulation on Production, Storage, and 
Transportation of Shell Eggs, 21 CFR part 118, which allows for offsite 
storage of records, except for the written Salmonella Enteritidis 
prevention plan, which must be stored on-site (see Sec.  118.10).

D. Use of Existing Records (Sec.  112.163)

    (Comment 395) Several commenters express support for proposed Sec.  
112.163, and ask that we clarify that records already kept for other 
purposes and information presented across multiple records in different 
forms are sufficient to meet the recordkeeping requirements of the 
produce safety regulation.
    (Response) We are revising proposed Sec.  112.163 to provide 
additional clarity about the fact that the regulations in part 112 do 
not require duplication of existing records if those records contain 
all of the information required by part 112. We have minimized the 
burden of keeping records to that which is necessary to accomplish the 
intended purposes of part 112. As discussed in the 2013 proposed rule, 
for example, you are not required to duplicate existing records, such 
as records kept to satisfy the requirements of the NOP, 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, the 
produce safety regulation provides you the flexibility to keep any 
additional information required by this part either separately or 
combined with your existing records, even where the formats for each 
record may not be the same. However, note 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.
    To make our intent clear, and consistent with a similar provision 
Sec.  117.330 in the PCHF regulation, we are revising proposed Sec.  
112.163 to read as follows: (a) Existing records (e.g., records that 
are kept to comply with other federal, State, or local regulations, or 
for any other reason) do not need to be duplicated if they contain all 
of the required information and satisfy the requirements of this part 
112. Existing records may be supplemented as necessary to include all 
of the required information and satisfy the requirements of this part 
112; and (b) The information required by this part does not need to be 
kept in one set of records. If existing records contain some

[[Page 74513]]

of the required information, any new information required by this part 
may be kept either separately or combined with the existing records.
    We acknowledge that the records required by this part may be multi-
component--a web of related documents. This provision provides 
flexibility, but it is not without limitations. As an example, a farm 
that collects spent sprout irrigation water samples and sends them to a 
laboratory for testing may have sampling records that contain the 
information required by Sec.  112.161(a)(1), such as the name and 
location of the farm, the date when the samples were collected, the 
signature or initials of the person collecting the samples and an 
adequate description of the sprouts applicable to the record (including 
a lot number or other identifier, when available). The laboratory 
report may not include some of the information, such as the location of 
the farm, but would contain some identifying information relating to 
the sample tested, such as the date of the sample or the lot number for 
the applicable sprouts. These records together contain all the required 
information to associate them with a farm and a specific lot of 
product. However, the following example for monitoring records 
illustrates there can be limitations on supplementing existing records 
with required information kept in other documents. Monitoring records 
must be created concurrently with the monitoring activity and contain 
the signature or initials of the person conducting the monitoring. If 
the existing records document the monitoring activity and the date and 
time but do not provide space for the name and location of the farm or 
the signature or initials of the person performing the activity, it 
would not be acceptable to supplement that record with the name and 
location of the farm and signatures on a separate page.

E. Length of Records Retention (Sec.  112.164)

    We received some comments generally supporting proposed Sec.  
112.164. We are retaining Sec.  112.164 with certain changes. First, we 
are adding new Sec.  112.164(a)(2) to require that records that a farm 
relies on during the 3-year period preceding the applicable calendar 
year to satisfy the criteria for a qualified exemption, in accordance 
with Sec. Sec.  112.5 and 112.7, must be retained at the farm as long 
as necessary to support the farm's status during the applicable 
calendar year. As discussed in section IX of this document, the 
criteria for a qualified exemption established in this rule (in Sec.  
112.5) are based, in part, on average sales during the 3-year period 
preceding the applicable calendar year. Thus, a farm that does not 
retain records documenting its sales during the 3 to 4 years prior to 
the applicable calendar year will not have documentation adequate to 
demonstrate its eligibility for the qualified exemption. The actual 
retention time necessary to support its eligibility during the 
applicable calendar year could be as long as 4 years. For example, if a 
farm were to be inspected on May 1, 2024, the farm would have retained 
the records from 2021-2023 for 3 years and four months. On the other 
hand, if a farm were to be inspected on December 28, 2024, the farm 
would have retained the records from 2021-2023 for nearly 4 years.
    Second, we are making a corresponding revision to Sec.  
112.164(a)(1) to replace ``2 years'' with ``at least 2 years'' so the 
length of record retention in this provision is harmonized with new 
Sec.  112.164(a)(2).
    Finally, we are revising Sec.  112.164(b) to make clear that it 
covers such records as those related to analyses, sampling, or action 
plans being used by a farm, including the results of scientific 
studies, tests, and evaluations. For example, the initial or annual 
surveys that a farm conducts to develop or update the microbial water 
quality profile under Sec.  112.46(b) can be comprised of data derived 
from water tests conducted within the previous 4 years, and these 
results inform the farm's use of that agricultural water in accordance 
with Sec.  112.45. Because these results are necessary to verify the 
use of the agricultural water in compliance with the microbial quality 
criteria in Sec.  112.44 as well as any time interval in compliance 
with the microbial die-off provisions in Sec.  112.45(b)(1)(i) and/or 
(b)(1)(ii), we conclude a retention period of 2 years after their use 
is discontinued (i.e., 2 years after the test results are used to 
inform the microbial water quality profile) is warranted for these 
water test results. Likewise, the written environmental monitoring plan 
(required under Sec.  112.145) and written sampling plan (required 
under Sec.  112.147) that a sprouting operation establishes and 
implements must be retained at the farm for at least 2 years after 
their use is discontinued.

F. Acceptable Formats for Records (Sec.  112.165)

    (Comment 396) Several comments express concern about the proposed 
requirement in proposed Sec.  112.165(c) that any electronic records 
maintained to satisfy the requirements of part 112 be kept in 
compliance with part 11 of this chapter. These commenters state that 
while large operations may have invested in part 11-compliant software, 
other farm operations currently maintain electronic records using 
commonly available software, such as Excel. Comments also state that 
only a few farms currently have the computer training necessary to 
implement the requirements of part 11, and that adapting their existing 
systems to be in compliance with part 11 would require significant 
investments by many farms. These commenters request that the 
requirement for electronic records to comply with part 11 be deleted 
from the final produce safety regulation. In addition, one commenter 
recommends that FDA provide information in guidance as to how 
operations should protect electronic records from intentional or 
unintentional falsification. In contrast, another commenter agrees that 
electronic records should be required to be in compliance with part 11. 
This commenter notes that most electronic records include a date stamp 
indicating when they were last modified, suggesting that this should be 
considered sufficient evidence of compliance with part 11 and allow 
such records to be considered original records.
    (Response) We agree that the need to redesign large numbers of 
already existing electronic records and recordkeeping systems would 
create a substantial burden, particularly in light of frequent software 
patches and security updates and the use of open source software by 
some farms. Therefore, we are revising Sec.  112.165(c) to provide that 
records that are established or maintained to satisfy the requirements 
of part 112 and that meet the definition of electronic records in Sec.  
11.3(b)(6) are exempt from the requirements of part 11. We also are 
specifying that records that satisfy the requirements of part 112, but 
that also are required under other applicable statutory provisions or 
regulations, remain subject to part 11. This rule provides that a farm 
may rely on existing records to satisfy the requirements of this rule, 
and this rule does not change the status under part 11 of any such 
records if those records are currently subject to part 11. As we did in 
the PCHF regulation, we are establishing a conforming change in part 11 
to specify in new provision Sec.  11.1(k) that part 11 does not apply 
to records required to be established or maintained under part 112, and 
that records that satisfy the requirements of part 112, but

[[Page 74514]]

that also are required under other applicable statutory provisions or 
regulations, remain subject to part 11. Although we are not specifying 
that part 11 applies, covered farms should take appropriate measures to 
ensure that electronic records are trustworthy, reliable, and generally 
equivalent to paper records and handwritten signatures executed on 
paper.
    Note, however, that we are not requiring electronic records. 
Indeed, to minimize the burden this regulation may have on covered 
farms, FDA is not specifying the form or format of the records that 
must be established and maintained except as set forth in part O. To 
satisfy the requirements of the produce safety regulation, paper or 
electronic records or a combination of the two may be used. We also 
expect that the training curriculum and materials being developed by 
the PSA and SSA will include training on how to develop and maintain 
appropriate records.

G. Disclosure of Records Submitted to FDA (Sec.  112.167)

    (Comment 397) One comment asks FDA to affirm that the regulations 
under 21 CFR part 20 will be followed. This comment also generally 
expresses concern about disclosure of confidential information 
submitted by a covered farm to FDA, and that small businesses may not 
be fully aware of FDA's ability to disclose certain types of materials. 
The commenter asks FDA to provide guidance to assure that covered farms 
understand FDA's procedures for publicly disclosing certain submitted 
materials.
    (Response) We understand the concerns regarding confidentiality. 
Section 112.167 explicitly states that records obtained by FDA in 
accordance with part 112 are subject to the disclosure requirements 
under 21 CFR part 20. 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 
21 CFR part 20, which include protection for confidential commercial 
information and trade secrets. 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. We will consider addressing this topic in our SECG to be 
issued in the near term following this rule. We are revising this 
provision to specify that records obtained by FDA in accordance with 
this part are subject to the disclosure requirements under part 20. FDA 
is making this change to clarify that the requirements in part 20 
attach to those documents obtained by FDA under this rule.

XXI. Subpart P--Comments on Variances

    In subpart P of proposed part 112, we proposed a process by which a 
State or a foreign country may request a variance(s) from one or more 
requirements of part 112, consistent with the statutory provisions in 
section 419(c) of the FD&C Act. We proposed that the competent 
authority for a State or foreign country submit the petition requesting 
the variance, what information must accompany such requests, and the 
procedures and circumstances under which FDA may grant or deny such 
requests, and modify or revoke such variances.
    We asked for comment on our proposed provisions in subpart P for 
variances, including related process and scientific data and 
information to 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. We also asked whether there are any 
specific concerns that we should consider in finalizing the procedures 
and processes for requests for variances, as applicable to foreign 
governments.
    We are finalizing these provisions with revisions (see Table 27). 
We discuss these changes in this section. We are finalizing the other 
provisions of subpart P without change. For Sec. Sec.  112.174, 
112.175, 112.177, 112.178, 112.179, 112.180, and 112.181, we did not 
receive any comments or received only general comments in support of 
the proposed provision and, therefore, we do not specifically discuss 
these provisions further.

             Table 27--Description of Revisions to Subpart P
------------------------------------------------------------------------
       Final provision                  Description of revisions
------------------------------------------------------------------------
Sec.   112.171...............  --Revision to establish that Federally-
                                recognized tribes may submit a variance
                                petition; and corresponding changes
                                throughout subpart P.
Sec.   112.172...............  --Revision to make clear that a competent
                                authority, for purposes of submitting a
                                request for a variance in accordance
                                with this rule, is the regulatory
                                authority for food safety (replacing
                                ``e.g.,'' with ``i.e.'').
Sec.   112.176...............  --Revision of Sec.   112.176(b) to
                                replace ``either'' with ``e.g.'' to make
                                clear that the situations described are
                                merely examples and not limitations on
                                who may comment.
                               --Editorial revision to treat ``website''
                                as one word.
Sec.   112.177...............  --Editorial revision to treat ``website''
                                as one word.
Sec.   112.179...............  --Editorial revision to add the word
                                ``on'' before ``the date of our written
                                decision''.
Sec.   112.181...............  --Editorial revision to treat ``website''
                                as one word.
Sec.   112.182...............
                               --Revision to clarify that the
                                permissible types of variances are not
                                limited to the examples provided (adding
                                ``A variance(s) may be requested for one
                                or more requirements in subparts A
                                through O in part 112'').
                               --Revision to include additional examples
                                and delete examples that are no longer
                                applicable due to revisions in other
                                sections of part 112.
                               --Revisions to update cross references in
                                examples and descriptions of cross
                                referenced requirements.
------------------------------------------------------------------------

A. Requesting a Variance (Sec. Sec.  112.171 and 112.172)

    (Comment 398) Several comments express concerns about the lack of 
allowance for tribes to request variances from the requirements of part 
112.
    (Response) Tribal governments may request a variance(s) from part 
112 under the same provision that permits States to request a 
variance(s) from part 112. FDA interprets 21 U.S.C. 350h(c)(2) to allow 
Federally-recognized tribes (which we refer to in the rule as 
``tribes'') to be treated in the same manner as States for the purpose 
of the variance provision. Therefore, any one or more of Federally-
recognized tribes may submit a variance petition, in accordance with 
Sec.  112.171, and all other provisions in subpart P that apply to a 
petition submitted by a State apply equally to a petition submitted by 
a

[[Page 74515]]

Federally-recognized tribe (Ref. 246). In light of comments, we are 
adding ``tribe'' in part 112 to clarify for purposes of this rule that 
``tribes'' are included. To make this explicit, we are revising Sec.  
112.171 to establish that a State, tribe, or foreign country may submit 
a petition requesting a variance(s) from the requirements of part 112, 
and making corresponding revisions throughout subpart P.
    (Comment 399) One comment seeks clarification on who would be 
considered a competent authority for a State or foreign government, as 
proposed in Sec.  112.172.
    (Response) A competent authority is commonly understood to be a 
person or organization that has the legally delegated or invested 
authority, capacity, or power to perform a designated function. For the 
purposes of the produce safety regulation, a competent authority is the 
regulatory authority for food safety for a State (e.g., State 
Department of Agriculture, etc.), tribe, or a foreign country importing 
food into the United States. Our reference to this term in the produce 
safety regulation is consistent with the use of term in other 
regulatory contexts. For example, competent authority is used in 
various Codex guidelines, referring to the official government agency 
having jurisdiction (Ref. 247) (Ref. 248). This term is also used to 
refer to relevant regulatory authorities in the European Union (Ref. 
249). We are editing Sec.  112.172 to replace ``e.g.'' with ``i.e.'' to 
make this clear.
    (Comment 400) Some comments state that entities allowed to submit 
variance requests should not be limited to State and foreign 
governments. A number of comments contend that additional groups, 
including State and federal commodity organizations, commodity boards, 
commodity commissions, trade associations, or other coalitions of farms 
should also be permitted to request variances using the same procedures 
available to States and foreign governments. These comments maintain 
that such groups are more likely to encompass the affected industry and 
are in a better position to consider and represent the risks and 
practices of the covered commodity. One comment states that a commodity 
commission is a State entity and should be able to submit a variance on 
behalf of a State. Some comments note that commodity boards have long 
partnered with research institutions and farms to investigate ways to 
improve produce safety, and are well positioned to present the 
information necessary to support a variance request. Some comments also 
state that allowing petitions for variances from parties other than 
State governments would reduce the burden currently placed solely on 
State agencies.
    (Response) The provision in Sec.  112.171 establishes that a State, 
tribe, or foreign country from which food is imported into the United 
States may request a variance from one or more of the requirements 
proposed in part 112. This provision implements the statutory 
provisions in sections 419(c)(1)(F) and 419(c)(2)(A) of the FD&C Act, 
which specify the criteria for the final regulation and explicitly 
provide for ``States and foreign countries from which food is imported 
into the United States'' to request variances from the requirements of 
the produce safety regulation. These statutory provisions do not 
identify private industry groups or trade associations. With respect to 
an entity that may be a State entity, such as a State commodity 
commission, but that is not the competent authority for that State, 
such entities are not eligible to request a variance. We are limiting 
this provision to competent authorities for a State, tribe, or foreign 
country because these entities with legally delegated or invested 
authority for food safety issues are the most appropriate to represent 
a State, tribe, or foreign country in food safety regulatory matters.
    FDA recognizes the knowledge of industry groups and appreciates 
their contributions to public and private partnerships to improve 
produce safety. FDA also appreciates that many groups have already 
instituted or are developing their own commodity-specific programs and 
guidelines (for example, in the case of strawberries, tomatoes, leafy 
greens, potatoes, and mushrooms) as well as with programs and guidance 
that cut across different commodity groups (for example, the AFDO Model 
Code; the Global GAPs (Ref. 250); and the Produce GAPs Harmonization 
Initiative (Ref. 251) (Ref. 252)). As noted previously, the processes 
in part 112, subpart P, do not preclude any entity from working with 
the competent authority (i.e., the regulatory authority for food 
safety) for their State, tribe, or foreign country to develop a 
petition to request a variance. FDA anticipates that industry groups 
and other relevant stakeholders would be willing to provide assistance 
to reduce the burden on States, tribes, and foreign governments, 
including, as appropriate, by developing the necessary scientific data 
to support a request for a variance and/or drafting the variance 
petitions for signature and submission by the State, tribe, or foreign 
country. As discussed in the paragraphs that follow, FDA also intends 
to take a number of steps, including providing for pre-submission 
consultations and making public scientific data and other information 
in petitions submitted, which may further ease the burden on States, 
tribes, and foreign governments with similarly situated covered farms.
    (Comment 401) A comment states that the process of submitting a 
variance would require significant resources.
    (Response) As noted previously, if a State, tribe, or foreign 
government chooses to submit a variance, we encourage them to work with 
other entities to develop variance petitions. FDA also intends to take 
a number of steps to provide assistance to States, tribes, and foreign 
governments interested in submitting petitions requesting a variance, 
including providing for pre-submission consultations and making public 
scientific data and other information in petitions submitted (see Sec.  
112.174), which may ease the burden on States, tribes, and foreign 
governments. In addition, in accordance with Sec.  112.177, we may 
extend a variance granted to a State, tribe, or foreign government 
petition to another State, tribe, or foreign country that requests a 
similar variance for covered farms who are similarly situated within 
its jurisdiction.
    (Comment 402) One comment requests us to follow the World Trade 
Organization (WTO) Agreement on the Application of Sanitary and 
Phytosanitary Measures (SPS Agreement) guidelines for the process for 
requests for variances from foreign competent authorities. This comment 
notes unfamiliarity with the petition process in Sec.  10.30, but 
expects FDA to compare and contrast, and modify the currently proposed 
process to fit with WTO guidelines.
    (Response) The process established under part 112 is appropriate 
not only for the petitioners for a variance, but also for the specific 
nature of the determinations that FDA is required to make when 
considering a variance request. In developing this process, FDA took 
into account WTO guidelines for considering petitions for variance, 
including documents by the relevant international organizations such as 
the Codex. Where appropriate, the petition process established by this 
rule should satisfy the recommendations of such guidelines.

B. The Statement of Grounds in a Variance Petition (Sec.  112.173)

    (Comment 403) Comments generally support the proposed requirements 
related to processes, scientific data, and information to support a 
variance

[[Page 74516]]

request. Contrastingly, some comments request additional clarification 
on the scientific data and information necessary to support variance 
requests. Comments express concern with the availability, 
accessibility, and adequacy of the scientific data or information 
needed to demonstrate that the variance provides the same level of 
public health protection as the requirements of the produce safety 
regulation. Comments note that the lack of peer-reviewed scientific 
information will hamper the practicality and usefulness of the 
flexibility of variances, and information does not need to be published 
in peer reviewed journals in order to be used in support of a request 
for variance. Comments also support the use of industry-generated 
scientific data conducted through accredited or university 
laboratories, and suggest that data sets, methodology and analysis 
should be publicly shared so that other stakeholders can access and 
leverage such scientific information.
    (Response) With regard to the scientific data and information 
necessary to support variance requests, States, tribes, and foreign 
countries may, among other things, consult scientific papers. FDA 
agrees that information does not need to be published in peer reviewed 
journals in order to be used in support of a request for variance, 
although we encourage use of peer-reviewed data and information, to the 
extent available. A State, tribe, or foreign country is required to 
submit relevant and scientifically-valid information or materials 
specific to the covered produce and/or covered activity to support the 
petitioner's request for a variance(s) from corresponding requirements 
established in part 112. Depending on the variance(s) requested, this 
could 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. For example, a State, tribe, or foreign country may conclude 
that meeting certain requirements of the rule would be problematic in 
light of local growing conditions and that a variance from some or all 
provisions of this proposed rule is necessary. The State, tribe, or 
foreign country might consider 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. In requesting a variance, among 
other things, the State, tribe, 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 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 corresponding 
requirement(s) of the produce safety regulation for which a variance is 
requested. FDA encourages consideration of these types of information 
to support a request for a variance.
    For example, the microbial die-off rate of 0.5 log per day to 
determine an adequate time interval, no greater than four consecutive 
days, between last irrigation and harvest is established in Sec.  
112.45(b)(1)(i). We derived this die-off rate based on a review of 
currently available scientific literature that shows a range of 
microbial die-off rates of 0.5 to 2.0 log per day, dependent on various 
environmental factors, including sunlight intensity, moisture level, 
temperature, pH, the presence of competitive microbes, and suitable 
plant substrate. Generally, pathogens and other microbes die off or are 
inactivated relatively rapidly under hot, dry, and sunny conditions 
compared to inactivation rates observed under cloudy, cool, and wet 
conditions. Our analysis led us to conclude that a rate of 0.5 log per 
day provides a reasonable estimate of microbial die-off under a broad 
range of variables to include microbe characteristics, environmental 
conditions, crop type, and watering frequency (see discussion on 79 FR 
58434 at 58445-446; see also (Ref. 45)). Nevertheless, we acknowledge 
that practices and conditions on a farm and circumstances unique to a 
specific commodity could result in higher die-off rates between last 
irrigation and harvest, especially under conditions of high ultraviolet 
radiation, high temperature exposures or low humidity, coupled with 
little or no precipitation. A State, tribe, or foreign country may 
submit a petition for a variance to the microbial die-off rate, as well 
as to the accompanying maximum time interval between last irrigation 
and harvest, established in Sec.  112.45(b)(1)(i), along with 
scientific information and data demonstrating that the requested 
microbial die-off rate is appropriate for the specific crop, based on 
climate, soil, and/or geographical or environmental conditions of a 
particular region, and/or the processes, procedures, or practices 
followed in that region for the specific crop, as described in its 
petition to FDA. (Note that a covered farm can also establish an 
alternative microbial die-off rate and an accompanying maximum time 
interval, in accordance with Sec. Sec.  112.12(a) and 112.49(b), 
without the need for a variance for this specific requirement, although 
a variance approved by FDA could provide assurance to covered farms of 
the scientific basis for the deviation from FDA-established microbial 
die-off rate and also minimize the resource burden on individual farms 
developing the scientific support for an alternative as opposed to a 
State requesting a variance for all covered farms for which a variance 
would apply in a specified region.) Such scientific information and 
data may include scientific literature, such as research data on 
microbial populations and survival and/or die-off rates under 
conditions representative of that specific region (e.g., temperature, 
humidity, precipitation); weather station data comparing their 
environment to that in the scientific literature; any historical, 
reliable water sampling or survey data relevant to the specific region; 
and/or data on current industry practices for the commodity in the 
specific region. The weather conditions are likely to vary based on 
factors such as topographic and environmental conditions. Therefore, we 
envision that the information and data supporting such a request for a 
variance would demonstrate the microbial die-off between last 
irrigation and harvest for a specific commodity, and under the 
environmental conditions of a particular region, that is requested in 
the petition to FDA.
    Interested parties may work independently or in collaboration with 
their competent authority to compile supporting information for use by 
the State, tribe, or foreign country in its submission of a variance 
petition. In addition, Sec.  112.177 ensures consideration of the 
application of variances to similarly situated persons and provides for 
transparency and accountability in FDA's review of requests and 
decision-making. FDA also welcomes pre-petition consultations with 
interested States, tribes, or foreign countries to facilitate the 
development of variance petitions, including a discussion of the types 
of data and information that would be needed to support the specific 
variance the State, tribe, or foreign country expects to request in its 
petition.

C. Process for Requesting a Variance (Sec.  112.176)

    (Comment 404) One comment recommends that we clearly delineate the 
processes associated with the approval or denial of the variance, while 
another comment asks us to establish

[[Page 74517]]

criteria for how information supplied in support of variances will be 
evaluated.
    (Response) We are establishing the general procedures applying to 
variance petitions in Sec.  112.176. Under these procedures, a State, 
tribe, or foreign country from which food is imported into the United 
States may in writing submit a request for a variance(s) to the FDA 
using the process described in Sec.  10.30. Such a 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 produce safety regulation. Under 
the procedures described in Sec.  112.176, FDA will review such 
requests and may approve the variance requested either in whole or in 
part, as appropriate, and may specify the scope of applicability of the 
variance to other similarly situated persons. FDA 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. 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. 
If the petition is granted, either in whole or in part, FDA will 
specify the persons to whom the variance would apply and the 
provision(s) of part 112 to which the variance would apply. If the 
petition is denied (including partial denials), FDA will explain the 
reason(s) for the denial in its written response to the petitioner and 
will post this information on our Web site. We intend to make readily 
accessible to the public, and periodically update, a list of filed 
petitions requesting variances, including the status of each petition.
    In evaluating petitions, FDA will look to see if the petition 
addressed the relevant requirements, for example, whether the petition 
included information on the need for the variance and that procedures, 
processes, and practices to be followed under the variance provide the 
same level of public health protection as the relevant requirement(s) 
of part 112 (see Sec.  112.171). We will also look for a Statement of 
Grounds describing 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 (Sec.  112.173(b)). We will 
assess whether the scientific information, data, and materials included 
in the petition sufficiently support the variance requested and 
accompanying rationale for the request. If FDA finds that we need 
additional information to make a decision, we intend to communicate 
with the petitioner. As noted previously, we welcome pre-submission 
consultations so that data and information necessary to adequately 
support a specific variance can be identified. FDA anticipates 
providing guidance and other information, as appropriate, to assist 
States, tribes, and foreign countries in preparing petitions for 
requests for variances and developing the necessary scientific basis to 
support such requests.
    (Comment 405) One comment asks whether we would be able to assess 
and provide a decision on variance requests before the implementation 
date if FDA were faced with large number of variance applications. This 
comment also suggests that, if we are not able to decide on a variance 
request before the implementation date, variance requestors should be 
able to continue operating under their existing practices until the FDA 
decision has been made. Another comment states that rapid approval of 
variances is a critical component to ensuring continuity in farming 
operations in areas where water quality is an issue yet food safety of 
certain commodities has not been impacted.
    (Response) We expect the compliance periods we have established for 
this rule allow sufficient time for variance petitions to be developed, 
submitted, and reviewed by FDA. Per section 419(c)(2)(A) of the FD&C 
Act, FDA will review variance petitions and respond to petitioners in a 
reasonable timeframe. FDA welcomes pre-petition consultations, which 
could facilitate FDA's timely review and decisions on variance 
petitions.
    (Comment 406) Comments asked us to establish a stakeholder group to 
review variances.
    (Response) We deny the request to establish a stakeholder group to 
review variances submitted to FDA. Rather, FDA will review all variance 
petitions submitted to the agency. However, the citizen petition 
process, which we are employing in relation to requests for variances, 
allows opportunity for stakeholders to provide comment on variance 
petitions filed with FDA, including on the requested variance and the 
scientific merits of the request.

D. Permissible Types of Variances (Sec.  112.182)

    (Comment 407) One comment notes that while a variance can be 
requested for one or more requirements of the produce safety 
regulation, the examples of permissible types of variances provided in 
Sec.  112.182 of the rule creates the impression that only variances in 
those areas will be approved. This comment requests us to revise this 
provision to make it clear that a variance is not limited to certain 
elements of the rule.
    (Response) The list in Sec.  112.182 is intended to provide 
examples of the types of variances that may be requested and, if FDA 
deems appropriate, granted. Therefore, variance petitions are not 
intended or required to be limited to these examples. A State, tribe, 
or foreign country may request a variance from any one or more 
requirements in subpart A through subpart O in part 112, under the 
conditions described in Sec.  112.171. We are revising Sec.  112.182 to 
make our intent clear and to revise and update the list of examples. As 
revised, Sec.  112.182 states that a variance(s) may be requested for 
one or more requirements in subpart A through O in part 112. Examples 
of permissible types of variances include: (1) Variance from the 
microbial quality criteria when agricultural water is used during 
growing activities for covered produce (other than sprouts) using a 
direct water application method, established in Sec.  112.44(b); (2) 
variance from the microbial die-off rate that is used to determine the 
time interval between last irrigation and harvest, and/or the 
accompanying maximum time interval, established in Sec.  
112.45(b)(1)(i); and (3) variance from the approach or frequency for 
testing water used for purposes that are subject to the requirements of 
Sec.  112.44(b), established in Sec.  112.46(b).

E. Other Comments

    (Comment 408) One comment seeks clarification on how a variance 
request would work for countries seeking equivalence or systems 
recognition arrangements. This commenter states that FDA recognition of 
food safety systems in the foreign country should be an accepted 
variance to this rule. The organization also requests FDA to provide 
direction to foreign governments to help them determine which of the 
two options--a request for variance or for systems recognition--is more 
appropriate given their particular circumstances.
    (Response) Variances, systems recognition, and equivalence are 
distinct regulatory tools, each requiring

[[Page 74518]]

different analyses, although they do overlap somewhat. As described in 
this rule, a foreign country may submit a request for a variance(s) by, 
among other things, demonstrating that local conditions and practices, 
while different, achieve the same level of public health protection as 
the relevant standard under the produce safety regulation. Variances 
may be requested for one or more requirements established under part 
112. Systems recognition, as developed by FDA, applies to and evaluates 
the robustness of a foreign country's oversight of their food safety 
system and its comparability with United States controls and standards 
based on a comparison of key elements of the overall food control 
system and a rigorous in-country audit of food safety controls. 
Equivalence, as described in the WTO SPS Agreement, provides for 
exporting countries to demonstrate that they achieve the importing 
member's appropriate level of protection. Equivalence can be determined 
for a specific measure, a set of measures, or the entire food control 
system.
    A country does not need equivalence or a systems recognition 
arrangement to obtain a variance. Systems recognition involves an 
intensive and extensive review of key aspects of the overall food 
safety control system. Indeed, an overall food safety system may not be 
comparable to that of the United States for FDA-regulated products, but 
the country may be able to successfully demonstrate that a specific 
produce production practice or set of practices provides the same level 
of public health protection for a specific measure or a set of measures 
as described in the requirements contained in part 112 of this rule.
    Ideally, FDA's systems recognition of a food control system should 
include a successful assessment of its produce production practices. 
However, it is premature to determine that variances will not be needed 
or considered for countries with existing or future arrangements. We 
note that FDA's pilot systems recognition activities pre-date FSMA and 
FDA is currently refining the program and transitioning it from a pilot 
to the full program operations stage. Part of this process entails 
ensuring alignment, where appropriate, with FSMA. While all systems 
recognition assessments have followed a similar process, each 
assessment varies in scope of the review for oversight of specific 
products. In the future, FDA will likely consider including additional 
consideration for produce standards, oversight and production practices 
particularly with respect to the country's practices and oversight 
regarding the specific provision(s) in part 112 in its systems 
recognition assessments. Any proposed changes to our process for 
existing arrangements and future assessments will be transparent and 
publically notified. For existing arrangements, FDA will work with the 
regulatory partner to determine if additional evaluation may need to be 
considered for any proposed variances.
    Given varying scenarios and possibilities regarding the scope of 
each respective systems recognition arrangement currently being 
considered, FDA concludes that whether or how requests for a variance 
relate to current and future systems recognition assessments will need 
to be evaluated on a case-by-case basis and will be undertaken in 
consultation with the foreign country involved.
    More information on systems recognition can be found at FDA's Web 
site: http://www.fda.gov/food/internationalinteragencycoordination/ucm367400.htm.
    (Comment 409) One comment asks whether FDA considered extending the 
applicability of a variance to produce that is subject to another 
United States government regulatory framework that provides the same 
level of public health protection as the produce rule. This comment 
maintains that not recognizing the requirements mandated by another 
United States government regulatory framework could result in 
duplicative or contradictory standards and costs, with no additional 
public health benefit.
    (Response) We are not aware of any federal regulatory programs that 
are duplicative of the produce safety regulation. We welcome pre-
petition meetings to discuss any such regulatory programs and how the 
provisions of subpart P might apply.
    (Comment 410) One comment expresses concern that although State-by-
State variances can provide appropriate relief and recognition for 
localized alternate approaches, they can create a patchwork effect 
instead of uniform protection, especially if one State has the 
resources to pursue a variance and another does not. This comment 
suggests that a different approach to variances may be to take a 
regional approach for certain aspects of the rule, or to implement 
first only those portions of the rule that can be applied uniformly or 
consistently while options for addressing more variable aspects are 
explored. The comment provides, as an example, that risk-based modeling 
or system-wide approaches may be appropriate methods for assessing risk 
and conditions such as water quality, and that tested, safe, and common 
alternatives could be accommodated within the body of the rule as 
regional or condition-based standards, thus reducing the need for some 
variances.
    (Response) FDA agrees that some variances may be appropriate on a 
regional basis, not just at a State level. As discussed previously, 
this subpart provides a variety of mechanisms for applying some or all 
parts of a variance to other similarly situated persons, including to a 
region, rather than to a single State.

XXII. Subpart Q--Comments on Compliance and Enforcement

    In the 2013 proposed rule, we outlined our overall strategy for 
implementation and compliance (78 FR 3504 at 3608-3609). In subpart Q 
of proposed part 112, we included certain proposed provisions regarding 
how the criteria and definitions in part 112 relate to the FD&C Act and 
the PHS Act, the consequences of failing to comply with this part, and 
coordination of education and enforcement. We asked for comment on the 
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.
    We are finalizing these provisions with revisions (see Table 28). 
We discuss these changes in this section. We did not receive any 
comments or received only general comments in support of proposed Sec.  
112.191 and 112.192 and, therefore, we do not discuss final Sec.  
112.192 further.

[[Page 74519]]

                       Table 28--Description of Re-Arrangement and Revisions to Subpart Q
----------------------------------------------------------------------------------------------------------------
           Proposed provision                   Final provision                 Description of revisions
----------------------------------------------------------------------------------------------------------------
Sec.   112.191..........................  Sec.   112.192.............  --Revision to combine proposed Sec.  Sec.
                                                                          112.191 and 112.192, all of which
                                                                        relate to the applicability and status
                                                                        of part 112, including the results of
                                                                        failures to comply with part 112, into
                                                                        one section.
                                                                       --Revision to include proposed Sec.
                                                                        112.191 as new provision Sec.
                                                                        112.192(b), along with revisions for
                                                                        clarity to separate the authorities
                                                                        cited from FD&C Act from that cited from
                                                                        the PHS Act.
Sec.   112.192..........................
Sec.   112.193..........................  Sec.   112.193.............  --Revision to clarify that FDA
                                                                        coordinates education and enforcement
                                                                        activities by State, territorial,
                                                                        tribal, and local officials ``by helping
                                                                        develop education, training, and
                                                                        enforcement approaches''.
----------------------------------------------------------------------------------------------------------------

A. General Comments on Compliance and Enforcement Strategy

    (Comment 411) Several comments ask for information on FDA's 
compliance strategy. One comment urges that inspections, which the 
commenter feels will assure compliance and promote consumer confidence, 
should be the center of FDA's core strategy. Noting FDA's limited 
resources, one comment encourages FDA to adopt a voluntary program, 
rather than require compliance with a regulation, and asserts that FDA 
should pursue meaningful relationships with producers in order to make 
the goal of the produce safety rule a reality. One comment asks FDA and 
other relevant agencies to ensure their implementation strategies 
include and are informed by community input. Another comment suggests 
that FDA's priority during the first several years after the regulation 
is finalized should be on education rather than enforcement.
    (Response) During this rulemaking process, our FSMA implementation 
teams have been working concurrently on developing strategies and 
frameworks to operationalize the new FSMA prevention-focused food 
safety standards, including the produce safety rule. In May 2014, FDA 
published ``Operational Strategy for Implementing the Food Safety 
Modernization Act (FSMA)'' which describes guiding principles for FSMA 
implementation, including for the produce safety rule (Ref. 253). 
Stakeholder engagement is also central to operationalizing FSMA. FDA 
has engaged and sought input from the farming community and other 
stakeholders consistently throughout this rulemaking process. In 
addition, FDA held a public meeting on April 23-24, 2015 and opened a 
public docket to present our current thinking and gather stakeholder 
input on our operational work plans (Ref. 254) (Ref. 255). FDA intends 
to make the FSMA operational work plans public, once they are 
finalized.
    FDA's implementation of the produce safety rule will entail a 
broad, collaborative effort to foster awareness and compliance through 
guidance, education, and technical assistance, coupled with 
accountability for compliance from multiple public and private sources, 
including FDA and partner agencies, USDA audits, marketing agreements, 
and private audits required by commercial purchasers. In keeping with 
this broad vision, FDA intends to focus its efforts on:
    [ssquf] Deploying a cadre of produce safety experts in headquarters 
and the field with the depth and breadth of capacity to develop the 
guidance needed to support implementation and provide technical support 
to government and industry parties working to foster compliance;
    [ssquf] Actively supporting education and technical assistance for 
farms, primarily through collaboration with other public and private 
parties;
    [ssquf] Supporting public and private parties involved in audits 
and other accountability functions with technical assistance and other 
collaborative support;
    [ssquf] Conducting targeted on-farm surveys and inspections to 
understand current practices and identify gaps in compliance;
    [ssquf] Taking administrative compliance and enforcement action 
when needed to correct problems that put consumers at risk;
    [ssquf] Responding to produce outbreaks effectively to lessen 
impact on public health; and
    [ssquf] Conducting in-depth environmental assessments where 
appropriate to identify root causes of outbreaks associated with 
produce and inform future prevention efforts.
    FDA's inspection resources will be targeted based on risk. In 
addition to conducting its own inspections, FDA also plans to rely 
heavily on States to conduct a large proportion of the routine 
inspections on farms. Thus, inspection will play an important role in 
the overall compliance effort.

B. FDA Enforcement Decisions

    (Comment 412) Several comments suggest specific criteria that FDA 
should use in determining how to respond to violations of this rule, 
such as whether the violation represents an ``immediate public health 
risk,'' and whether the farm demonstrates a willingness and effort to 
correct violations. Another comment requests that FDA be clear in 
explaining to farmers what is wrong to allow them to come into 
compliance. Some comments express concern about the potential impact of 
FDA's compliance and enforcement determinations on their business.
    (Response) We intend to assess a farm's compliance with this rule 
on a case-by-case basis. In considering what action is appropriate, we 
are likely to consider factors including the severity of the violation, 
the willingness of the farmer to cooperate and take corrective actions, 
and the risk to public health. While many farms already follow some or 
all of the requirements in this regulation, we recognize that this is 
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. Under 
the FD&C Act, FDA has authority to inspect produce farms and can take 
enforcement action when appropriate. However, we realize that no food 
safety regime can provide complete assurance against the emergence of 
foodborne illness, and there might be circumstances in which the 
failure to prevent foodborne illness might not mean that the farm has 
violated the Produce Safety rule. See also our response to Comment 411 
describing our implementation and enforcement strategy.
    (Comment 413) One comment suggests that compliance with FSMA should 
be presumed for certain farms. The comment cites North Carolina

[[Page 74520]]

Session Law 2013-265 (Senate Bill 63) (NC Farm Act of 2013) as 
providing protection to farmers by entitling them to ``a rebuttable 
presumption that the commodity producer was not negligent when death or 
injury is proximately caused by consumption of the producer's raw 
agricultural commodity'' under certain conditions.
    (Response) We are aware that North Carolina has passed this law in 
their State, and that other States may choose to establish similar 
laws. However, State law tort duties are not relevant for purposes of 
this rule.

C. Coordination of Education and Enforcement (Sec.  112.193)

    (Comment 414) Several comments address the degree to which FDA will 
enforce the rule, and the extent to which States will be involved. 
Several comments request clarification, including on the framework for 
coordination, timeline for inspection-related activities, expectations 
from State agencies, and securing necessary funds and resources. 
Several comments favor FDA working with State governments using 
existing established efforts, including State-industry educational and 
regulatory interfaces and assistance programs, as well as education and 
standards of current protocols developed by extension services, State 
departments, other farming good management practices, and local 
regulations. Several comments express a belief that such an approach 
would be most successful because State governments best know the 
realities of agricultural practices within their borders and often have 
an established history of successful inspection processes. Some 
comments express a preference for State agricultural agencies to be 
involved in compliance activities related to this rule, rather than 
other State agencies (such as health- or environmentally-oriented 
agencies), arguing that State agricultural agencies have a deep 
understanding of local agricultural practices and have developed strong 
working relationships with farmers. One comment notes some potential 
challenges with implementation by States, including that in some 
circumstances, State agencies lack the authority to enter farms. Some 
comments also express concerns related to resources necessary for 
States to conduct inspections.
    (Response) As discussed previously, we are revising Sec.  112.193 
to clarify that FDA coordinates education and enforcement activities by 
State, territorial, tribal, and local officials by helping develop 
education, training, and enforcement approaches. FDA plans to work 
closely with States to implement the produce safety rule. We agree that 
our State counterparts have substantial knowledge about the farms in 
their jurisdiction. 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 this rule. 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, tribal, 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, tribal, and 
local government agencies in this and other ways as we strive to obtain 
industry-wide compliance with this rule. We agree that FDA should 
leverage existing State programs when feasible. The roles of FDA and 
State partners are likely to vary based on the nature of the task and 
the State involved.
    We have entered into a cooperative agreement with NASDA to obtain 
critical information related to implementation of this rule, in 
partnership with State regulatory agencies (Ref. 256). As part of the 
cooperative agreement, NASDA will conduct an assessment of the current 
foundation of State law, the resources needed by States to implement 
this rule, as well as develop a timeline for successful implementation.
    In addition, FDA anticipates that some States may choose to adopt 
requirements modeled after the provisions of this rule and may choose 
to perform inspections under their own authorities to enforce the 
provisions of their State laws. Such actions would further drive 
compliance with the produce safety standards in this rule.
    (Comment 415) One comment notes that a State agency would not be 
the appropriate enforcement agency on tribal lands regarding food and 
water systems. This comment also states the final produce safety rule 
should include issuance of a tribal regulatory authority for training 
and implementation and limit the authority of State law enforcement 
officers on tribal lands, or exclude tribal lands altogether from State 
enforcement unless at the request of the tribe.
    (Response) FDA recognizes the importance of engaging tribal 
regulatory authorities for successful FSMA implementation on tribal 
lands. FDA intends to work collaboratively with tribal regulatory 
partners to develop the appropriate education, enforcement, and 
training needed to facilitate compliance with the produce safety 
regulation on tribal lands (see FDA's recently released FSMA training 
strategy at www.fda.gov/fsma). We do not expect to use State officials 
to conduct inspections on FDA's behalf on tribal lands, but rather we 
intend to work with tribal authorities to commission tribal officials, 
as appropriate, to conduct these inspections.
    (Comment 416) One comment requests adding to Sec.  112.193 a list 
of entities, including State and federal partners, that will be working 
with FDA to implement the rule, as well as a timeframe for when 
operations will begin.
    (Response) FDA declines to establish a list of partnerships in the 
regulatory text. Such partnerships may change over time. Similarly, our 
operations timeframes will depend on the specific operational 
strategies we adopt in various circumstances. We plan to make 
information on our FSMA operational work plans public as previously 
described in Comment 411.

D. On-Farm Inspections

    (Comment 417) Several comments seek information about on-farm 
inspections. Some comments argue that, because farmers make the 
majority of their money in a relatively small period of time, 
inspectors should be sufficiently familiar with agricultural 
production, harvesting, and handling methods to minimize potential 
disruptions to the farm business, particularly when inspections occur 
at the peak of harvest season. In addition, some comments ask FDA to 
develop specific training modules to ensure consistency in inspections 
and inspectors' awareness of farming practices. Some comments also 
recommend that inspectors should have familiarity with acceptable on-
farm practices taking into consideration the diversity of agricultural 
practices, conditions and commodities.

[[Page 74521]]

    (Response) See our response to Comment 411, in which we discuss our 
expectation that inspections will play an important role in the overall 
compliance effort, along with a range of other public and private 
efforts ranging from education, training, and technical assistance to 
private third-party audits. We anticipate developing educational 
materials related to compliance and enforcement activities for produce 
safety. As discussed previously (in Comment 411 and Comment 414), FDA 
plans to collaborate with State and other partners in implementing the 
produce safety rule. Personnel performing farm inspections may include 
federal investigators, State inspectors, or other authorities, and will 
likely vary by State. In addition, FDA plans to deploy a cadre of 
produce safety experts in headquarters and the field with the depth and 
breadth of capacity to support implementation and provide technical 
support to government and industry parties working to foster 
compliance.
    We anticipate that FDA and State investigators, as well as other 
partners conducting inspections, will receive joint training and 
education, which will include refresher training as needed. FDA intends 
to work closely with State, local, territorial, and tribal partners to 
develop the tools and training programs needed to help implementation 
activities, including inspections, to be conducted consistently. 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. Funding may be 
made available through various mechanisms, such as grant programs, to 
support inspector training.
    (Comment 418) Some comments ask questions regarding when farms 
would be inspected and for what reasons. Some comments ask FDA to 
clarify whether or not FDA may inspect a farm without prior notice. One 
commenter believes all farm inspections should be ``for-cause'' only, 
and that Congress did not intend for FDA to routinely inspect farms.
    (Response) FDA's authority to conduct on-farm examinations and 
investigations for the purposes of the FD&C Act is not limited to for-
cause situations and FDA is not required to give a farm prior notice of 
an inspection. As discussed in Comment 411, FDA intends to prioritize 
inspections based on risk. FDA intends to develop a work plan regarding 
routine farm inspections. FDA is exploring the possibility of pre-
announcing at least some farm inspections; however, there will likely 
be instances where a farm will not receive prior notice regarding an 
inspection.

E. Third-Party Audits, Inspections, and Other Arrangements

    (Comment 419) One comment urges FDA to encourage retailers and 
other customers who require audits to minimize the number of individual 
audits and align the standards against which farms are audited with the 
standards in the produce safety regulation. The comment notes that such 
an approach will minimize the economic and operational burden created 
by multiple audits, especially on smaller operations.
    (Response) FDA supports streamlining audit standards for efficiency 
and supports harmonizing existing industry standards with the 
requirements of this rule. We also recognize the value in industry's 
continued development of innovative and effective methods to ensure the 
production of safe foods.
    (Comment 420) Several comments note the existence of third-party 
audits, stating that existing groups already conduct various farm 
audits. Some comments suggest that FDA should utilize these third-party 
audits as part of FDA's compliance strategy for this rule. Some 
comments ask FDA to ``recognize'' certain types of audits as sufficient 
for certain purposes.
    (Response) FDA anticipates that significant incentives and 
accountability for compliance with this rule will come through third-
party audits and supply chain management initiated by produce farms, 
their customers, or other private entities. As outlined in Comment 411, 
third-party audits are an important part of our overall compliance 
strategy. We believe it is important to have significant oversight of 
farms to ensure compliance with the rule. Thus, as a complement to 
State and FDA inspections of farms, we intend to leverage the conduct 
of reliable third-party farm audits by USDA and others, as well as 
compliance with marketing agreements, with a goal of annual 
verification of farms that must comply with the rule.
    In addition to audits conducted to meet buyer-specific criteria, 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 GAPs guide, USDA GAP and GHPs, CA LGMA 
and AZ LGMA standards, and other voluntary programs. Whether conducted 
under such programs or in response to specific buyer demands, 
adequately rigorous and reliable private audits can be an important 
additional tool for fostering food safety and ultimately compliance 
with this rule. We note further that private audits may be relevant to 
some aspects of compliance with the supplier verification requirements 
in the FSVP and preventive controls regulations, where a farm supplies 
produce to an importer or receiving facility that seeks to verify that 
the farm has adequately controlled applicable hazards.
    We intend to pursue the goal of making third-party audits an 
important part of our compliance strategy by building on current 
private audit activity and by working with the produce industry and 
other government and private partners to improve the rigor and 
reliability of private audits. We believe that strengthening both the 
quality and credibility of private audits will help improve food 
safety, especially if conducted on the basis of the standards in this 
rule, but it can also be the basis for streamlining current audit 
practices and making them more efficient. Potentially, a single annual 
audit that is recognized to be a rigorous and reliable means of 
verifying compliance with this rule could substitute for multiple 
audits conducted under disparate standards with less well-established 
credibility. We seek public-private collaboration to achieve this goal.
    We also note that in the final third-party certification rule 
(published elsewhere in this issue of the Federal Register), FDA is 
establishing a voluntary program for the accreditation of third-party 
certification bodies that may conduct audits and issue certifications 
for purposes of establishing an entity's eligibility to participate in 
VQIP or to satisfy conditions set forth under section 801(q) of the 
FD&C Act.
    FDA is not recognizing any auditing body in this produce safety 
rulemaking.
    (Comment 421) Some comments recommend that FDA should both permit 
the use of any government-approved inspector or inspection service and 
also require farms' customers to accept certification or approval by 
any such approved inspector or service. The commenters believe that 
this step is necessary to protect farms from having to pay large fees 
to private companies.
    (Response) It is beyond the scope of this rule to require that 
entities in a supply chain accept certifications or approvals provided 
by third-party inspection services for other entities in the supply 
chain. To the extent that the

[[Page 74522]]

comments request that FDA allow farms to undergo inspections or audits, 
nothing in this rule prohibits such use of inspection or auditing 
services.
    (Comment 422) One comment suggests that, where FDA has systems 
recognition arrangements with foreign governments, importers who import 
produce from such countries should be subject to lesser requirements 
than they otherwise would be, and FDA should not inspect covered farms 
from that country.
    (Response) As discussed previously (see our response to Comment 
408), systems recognition involves an intensive and extensive review of 
key aspects of a country's overall food safety control system. The 
comment addresses the requirements applicable to an importer when there 
is a systems recognition arrangement. Requirements for importers are 
outside the scope of this produce safety rule. FDA addresses 
requirements applicable to importers who import food from countries 
whose food safety systems FDA has officially recognized as comparable 
or equivalent in the final FSVP rule (published elsewhere in this issue 
of the Federal Register).
    This comment also addresses FDA inspections of covered farms in 
countries with which FDA has systems recognition arrangements. Ideally, 
FDA's systems recognition of a food control system should include a 
successful assessment of its produce production practices. We note that 
FDA's pilot systems recognition activities pre-date FSMA, and FDA is 
currently refining the program to ensure alignment, where appropriate, 
with FSMA. While all systems recognition assessments have followed a 
similar process, each assessment varies in scope of the review for 
oversight of specific products. In the future, FDA will likely consider 
including additional consideration for produce standards, oversight, 
and production practices particularly with respect to the country's 
practices and oversight regarding the specific provision(s) in part 112 
in its systems recognition assessments. Further, systems recognition 
does not mean that no oversight of produce from such a country is 
warranted; therefore, it would not be appropriate to state that farms 
in countries with systems recognition are not subject to FDA 
inspection. It is also premature at this point to determine whether or 
how existing or future systems recognition arrangements may affect our 
inspections of foreign farms.

XXIII. Subpart R--Comments on Withdrawal of Qualified Exemption

    In the 2013 proposed rule, under subpart R of proposed part 112, we 
proposed to establish the procedures that would govern the 
circumstances and process whereby we may issue an order withdrawing a 
qualified exemption applicable to a farm in accordance with the 
requirements of proposed Sec.  112.5. Specifically, proposed Sec.  
112.201 listed the circumstances under which FDA may withdraw a 
qualified exemption applicable to a farm, while Sec. Sec.  112.202 and 
112.203 specified the procedure and information that FDA would include 
in an order to withdraw such qualified exemption. In addition, proposed 
Sec. Sec.  112.204 through 112.207 provided for a process whereby you 
may submit a written appeal (which may include a request for a hearing) 
of an order to withdraw a qualified exemption applicable to your farm, 
and proposed Sec. Sec.  112.208 through 112.211 provided a procedure 
for appeals, hearings, and decisions on appeals and hearings. We 
discussed each of the proposed provisions and explained our rationale 
(78 FR 3504 at 3611 through 3616). We requested public comment on our 
proposed provisions, including on related process and timeframes for 
actions to be taken by FDA and covered farms.
    In the supplemental notice, in part, taking into account public 
comment on the 2013 proposed rule, we proposed certain amendments to 
Sec. Sec.  112.201 and 112.202 related to the circumstances under which 
FDA may withdraw a qualified exemption and the procedure for issuing an 
order to withdraw a qualified exemption; and added a new proposed 
provision Sec.  112.213 to list the circumstances under which FDA would 
reinstate a farm's qualified exemption that is withdrawn. We asked for 
public comment on our new and amended proposed provisions (79 FR 58434 
at 58464-58467).
    In this section of this document we discuss comments that we 
received on the withdrawal provisions in the 2013 proposed rule, but 
that we did not address in the supplemental notice. We also discuss 
comments that we received on the new and amended proposed withdrawal 
provisions in the supplemental notice.
    We are finalizing the provisions in subpart R with revisions (see 
Table 29). We discuss these changes in this section. For Sec. Sec.  
112.202, 112.209, 112.210, and 112.211, we did not receive any comments 
or received only general comments in support of the proposed provision 
and, therefore, we do not specifically discuss these provisions 
further.

             Table 29--Description of Revisions to Subpart R
------------------------------------------------------------------------
       Final provision                  Description of revisions
------------------------------------------------------------------------
Sec.   112.201(b)(2).........  --Revision to allow 15 calendar days from
                                the date of receipt of an order to
                                withdraw a qualified exemption, for a
                                farm to respond in writing to our
                                notification.
Sec.   112.202...............  --Editorial change to insert the word
                                ``either'' in Sec.   112.202(a).
Sec.   112.203(c)............  --Editorial changes to clarify that the
                                order will specify which of two
                                circumstances that may lead FDA to
                                withdraw a qualified exemption apply, or
                                whether both of these two circumstances
                                apply.
Sec.   112.203(d)............  --Revision to require that the contents
                                of an order must include a statement
                                that the farm must either comply with or
                                appeal the order.
                               --Revision to require compliance with an
                                order to withdraw a qualified exemption
                                within 120 days of the date of receipt
                                of the order, consistent with the
                                timeline in the PCHF regulation; and
                                corresponding changes to Sec.  Sec.
                                112.204(a) and 112.205(b).
Sec.   112.203(e)............  --Include a statement informing the farm
                                that it may ask us to reinstate an
                                exemption that was withdrawn by
                                following the procedures in Sec.
                                112.213.
Sec.   112.204(b)............  --Revision to require that a farm may
                                request an informal hearing by
                                submitting a written appeal within 15
                                calendar days from the date of receipt
                                of the order; and corresponding changes
                                to Sec.  Sec.   112.206(a)(1) and
                                112.207(a)(2).
Sec.   112.205(b)(2).........  --Specifies that a farm that loses its
                                qualified exemption would no longer need
                                to comply with the modified requirements
                                in Sec.  Sec.   112.6 and 112.7.
Sec.   112.208(a)............  --Revision to allow for the hearing to be
                                held within 15 calendar days after the
                                date the appeal is filed.
Sec.   112.213(a)............  --Editorial change to replace the word
                                ``shall' with ``will''.
------------------------------------------------------------------------

[[Page 74523]]

A. Circumstances That May Lead FDA To Withdraw a Farm's Qualified 
Exemption (Sec.  112.201)

    (Comment 423) Some comments agree with the proposed provisions 
regarding certain actions we may take, and other actions we must take, 
before issuing an order to withdraw a qualified exemption. For example, 
some comments agree that other regulatory actions should be considered 
before withdrawing a qualified exemption, and some comments agree that 
it is appropriate to assess corrective actions taken by a farm in 
response to a food safety problem when considering whether to withdraw 
its exemption. Some comments recommend revising the wording in Sec.  
112.201(b)(1) from ``may consider'' to ``shall take'' thus requiring 
FDA to take alternative actions prior to withdrawing a qualified 
exemption. Other comments agree that these provisions are reasonable 
and will provide farms due process and greater clarity on the 
withdrawal process, but suggest that we could issue guidance rather 
than include these provisions in the rule to allow us greater 
flexibility should we have to act quickly to protect the public health.
    Other comments disagree with these proposed provisions and ask us 
to delete them from the final rule. These comments assert that FSMA 
does not require us to describe the actions that we may take prior to 
withdrawing a qualified exemption and that it is not necessary to do so 
because it is customary for us to work with regulated industry to 
address problems before taking enforcement actions. These comments also 
express concern that listing possible regulatory actions before we 
would issue an order to withdraw a qualified exemption could create an 
expectation that we will always exercise such regulatory actions before 
issuing the order. These comments also express concern that being bound 
by these provisions could prevent us from acting quickly to protect 
public health.
    (Response) We are retaining the provisions regarding certain 
actions we may take, and other actions we must take, before issuing an 
order to withdraw a qualified exemption. We agree that it is customary 
for us to work with industry to address problems before taking 
enforcement actions but disagree that specifying this customary 
practice in the rule would prevent us from acting quickly to protect 
public health. We consider that issuing an order to withdraw an 
exemption would be a rare event, in part because alternative actions 
such as those described in these provisions may provide a more 
expeditious approach to correcting a problem than withdrawing an 
exemption. We also disagree that the rule binds us to take alternative 
regulatory action before issuing an order to withdraw a qualified 
exemption, other than to notify the farm in writing of circumstances 
that may lead us to withdraw the exemption, provide an opportunity for 
the farm to respond in writing, and consider the actions taken by the 
farm to address the circumstances we describe. The rule clearly 
specifies that regulatory actions such as a warning letter, recall, 
administrative detention, refusal of food offered for import, seizure, 
and injunction are actions that we ``may'' (not ``must'') take before 
issuing an order to withdraw a qualified exemption. Providing the farm 
with an opportunity to correct the problems before we take steps to 
withdraw an exemption has the potential to save agency resources 
associated with preparing an order, responding to an appeal of the 
order and request for a hearing, and administering a hearing. Directing 
resources to help a farm to correct problems, rather than to administer 
a withdrawal process that could be resolved by the time of a hearing, 
is appropriate public health policy.
    (Comment 424) Some comments ask us to specify that the notification 
of circumstances that may lead FDA to withdraw the exemption must 
include facts specific to the situation and information about how the 
farm can remedy the situation.
    (Response) By specifying that we must notify the farm of 
circumstances that may lead us to withdraw an exemption, we mean that 
we would include facts specific to the situation. It is the 
responsibility of the farm, not FDA, to remedy the situation.
    (Comment 425) Some comments recommend that both the initial notice 
of intent to withdraw and the withdrawal order itself should be based 
on an individualized, case-by-case determination, and should not apply 
to a group or class of farms.
    (Response) The decision to withdraw a qualified exemption is an 
individualized determination and will not be applied to a class of 
farms or farmers.
    (Comment 426) Some comments ask us to provide additional time for a 
farm to respond, in writing, to a notification of circumstances that 
may lead us to withdraw its qualified exemption. Some of these comments 
request timeframes such as 2 weeks or 90 days for a farm to compile 
information and documentation of facts and to respond to FDA's 
notification.
    (Response) We are revising Sec.  112.201(b)(2) to provide for 15 
calendar days, rather than 10 calendar days, for a farm to respond in 
writing to our notification. The 15-day timeframe is the same as the 
timeframe for responding to a warning letter. Circumstances that could 
lead us to withdraw a qualified exemption require prompt action on the 
part of a farm, just as circumstances that lead us to issue a warning 
letter require prompt action.
    (Comment 427) Several comments request that FDA notify the 
appropriate State regulatory agency before a farm's qualified exemption 
is withdrawn or reinstated.
    (Response) We decline this request. We are sensitive to the time 
required for various inspection activities and intend to communicate 
with States regarding our expectations for how to verify whether a farm 
meets the criteria for a qualified exemption. The qualified exemption 
status of a farm principally affects the requirements that it is 
subject to, and will be most useful to FDA and our food safety partners 
when preparing for inspection. At this time, we do not intend to 
establish a system notifying the applicable State authorities at a 
point in time when the qualified exemption status of a farm changes, 
whether as a result of withdrawal or reinstatement of the farm's 
qualified exemption or because the farm's business has grown to the 
point where it exceeds the criteria that must be met for a farm to be 
eligible for a qualified exemption.

B. Contents of an Order To Withdraw a Qualified Exemption (Sec.  
112.203)

    (Comment 428) Some comments recommend that the order specify which 
of the two circumstances (Sec.  112.201(a)(1) or Sec.  112.201(a)(2)) 
that could lead us to issue the order apply.
    (Response) We have made editorial changes to the regulatory text to 
make it more clear that the proposed provision to require us to include 
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, should specify which of these two 
circumstances apply, or whether both of these two circumstances apply. 
See the revised regulatory text for Sec.  112.203(c).

[[Page 74524]]

    (Comment 429) Several comments recommend that the written order 
withdrawing the qualified exemption should include a detailed 
description of the substantial, science-based evidence FDA has to 
support its finding for withdrawal of a qualified exemption, rather 
than a brief, general description, as described in Sec.  112.203(c). 
Comments argue that a brief, general description supporting the order 
to withdraw a qualified exemption is not sufficient to allow the farmer 
to adequately respond to the order or prepare for an appeal hearing. 
Comments also contend that FDA must be required to clearly and 
specifically identify the ``material conduct or conditions associated 
with the farm that are material to the safety of the food'' regulated 
under this rule. In addition, some comments assert that ``material 
conditions'' should be based on scientifically measureable traits that 
can be clearly identified as occurring on the individual farm and/or 
should be limited to conditions within the farm's control. Some 
comments recommend that we require FDA to meet an explicit evidentiary 
threshold to find that conduct or conditions exist on a farm sufficient 
to warrant withdrawal of the farm's exemption.
    (Response) We agree that the order must provide sufficient 
information to enable a farm to respond with particularity to specific 
evidence about the circumstances leading to the order. However, we 
disagree that the order must do so by including the specific 
information recommended by the comments, or that we should include an 
explicit evidentiary threshold, and we have not revised the proposed 
withdrawal provisions to incorporate the suggestions of these comments. 
A number of these comments appear to be more focused on whether the 
circumstances that lead us to issue an order meet an evidentiary 
standard than on explaining the problem so that a farm can both 
understand the problem and respond with particularity to the facts and 
issues contained in the order. The withdrawal provisions that we are 
establishing in this provision require the order to include 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. The requirements that we are establishing 
in this provision would enable the farm to understand the problem, have 
a dialogue with us as appropriate, and respond to the problem. In 
addition, we intend that the process of responding to the notification 
that we must send before issuing an order to withdraw a qualified 
exemption, including discussing the problems with FDA as warranted, 
would provide additional information to the farm to enable the farm to 
both understand the problem and respond to it. Also, as discussed in 
Comment 184 and Comment 186, conditions that are not within a farm's 
control may be material to the safety of the produce grown on that 
farm, and this rule includes certain provisions requiring covered farms 
to consider certain conditions that may not be under the farm's control 
as an important part of minimizing the risks presented by such 
conditions.
    (Comment 430) Some comments suggest that FDA should require 
confirmation of the delivery and receipt of the withdrawal order by the 
farm, such as through certified mail.
    (Response) We are not specifying that we send an order in a way 
that ensures its receipt. Although certified mail with confirmation of 
delivery is one way to ensure receipt, other methods are available, 
including delivery through private carriers that provide mechanisms to 
document receipt. FDA will likely use one of these methods to document 
receipt. In light of the provisions in Sec. Sec.  112.203, 112.204, 
112.205, 112.206, and 112.207 linking the timeframes for you to comply 
with, or appeal, an order to the date of receipt of the order (rather 
than to the date of the order) (see our responses to Comment 433 and 
Comment 434), it will be up to us to deliver the order in a way that 
provides us with evidence of receipt.
    (Comment 431) Some comments ask us to include in the order a 
statement that a farm may request that FDA reinstate an exemption that 
was withdrawn by following the procedures in Sec.  112.213.
    (Response) We are revising the requirements for the contents of an 
order as requested by these comments (see Sec.  112.203(e)).
    (Comment 432) One comment recommends that the order specify the two 
options that a farm has upon receipt of the order, similar to the 
withdrawal provisions in proposed 117.257(d) in the proposed human 
preventive controls rule.
    (Response) We agree that it would be useful for the order to itself 
specify the two options that a farm has upon receipt of the order, even 
though the order would otherwise include this information (because the 
order will contain the full text of the withdrawal provisions under 
Sec.  112.203(f)). In Sec.  112.203(d), we are requiring that the 
contents of an order must include a statement that the farm must either 
comply with or appeal the order.

C. Compliance With, or Appeal of, an Order To Withdraw a Qualified 
Exemption (Sec. Sec.  112.204, 112.205, and 112.206)

    (Comment 433) Several comments express that 60 calendar days in 
proposed Sec.  112.204(a) is not sufficient time for a farm to comply 
with an order withdrawing its qualified exemption. Several comments 
recommend revising proposed Sec. Sec.  112.203(d) and 112.204(a) to 
require compliance within 120 days of the date of receipt of the order, 
consistent with the parallel timeline in part 117. Other comments ask 
for 1 or 2 years to comply. Some comments also suggest that the 
timelines in both rules should be based on working or business days 
rather than on calendar days. Other comments ask us to consider 
provisions that would require compliance with only those portions of 
the rule that formed the basis for the revocation.
    (Response) As in the case of facilities subject to the PCHF 
regulation, we conclude that the nature of what a farm would need to do 
to comply with an order--i.e., comply with the full requirements for 
minimum science-based standards established in the produce safety 
regulation--makes the 60-day timeframe in the 2013 proposed withdrawal 
provisions insufficient. However, it is relevant that in contrast to 
the general compliance dates, the withdrawal provisions would only 
apply when a significant public health concern has been identified for 
a particular farm.
    We are revising Sec. Sec.  112.203(d), 112.204(a), and 112.205(b) 
to require compliance within 120 days of the date of receipt of the 
order, consistent with the parallel timeline in part 117. We believe 
that the 120-day timeframe is adequate, but we are adding flexibility 
such that a farm may request, with a justification in writing to FDA, a 
reasonable timeframe for compliance that exceeds 120 calendar days from 
the date of receipt of the order. FDA must grant the request for the 
farm to receive the extended timeframe. We are not generally extending 
the timeframe because circumstances that could lead us to withdraw a 
farm's qualified exemption require prompt action on the part of the 
farm. A farm that receives an order to withdraw its qualified exemption 
would have received advance notification of the

[[Page 74525]]

circumstances leading to the order and would have had an opportunity to 
correct the problems rather than have us proceed to issue the order 
(see Sec.  112.201(b)). If the farm requests a hearing, more than 40 
days could elapse between the date that the farm receives the order and 
the date that the presiding officer for the hearing confirms the order 
to withdraw the exemption. Given that the circumstances that would lead 
us to issue the order involve either (1) an active investigation of a 
foodborne illness outbreak that is directly linked to the farm; or (2) 
a determination that withdrawal of the exemption is necessary to 
protect the public health and prevent or mitigate a foodborne illness 
outbreak based on conduct or conditions associated with the farm that 
are material to the safety of the food that would otherwise be covered 
produce grown, harvested, packed and held at such farm, a delay of one 
to two years to comply with the rule is not warranted.
    We also do not believe that it would be appropriate to require a 
farm to come into compliance with only those provisions that formed the 
basis of the revocation. The provisions of subparts B through O are 
interrelated and operate as a system and, therefore, are not optimized 
through piecemeal implementation. However, FDA may consider staggered 
implementation as an option in granting a request for an extension of 
the timeframe to comply with an order to withdraw the qualified 
exemption for a farm.
    We also conclude that it is appropriate to link the timeframe for 
compliance to the date of receipt of the order, rather than to the date 
the order was issued. Doing so would be consistent with our other 
administrative procedures, such as appeal of an order for 
administrative detention (21 CFR 1.402).
    In the supplemental notice, we acknowledged the difference in our 
proposed timelines for compliance when a qualified exemption is 
withdrawn between the PCHF and produce safety regulations (79 FR 58434 
at 58467). We have made the administrative procedures associated with 
the withdrawal of a qualified exemption consistent to the extent 
practicable, and are revising the withdrawal provisions to require that 
a covered farm comply with an order to withdraw an exemption within 120 
calendar days of the date of receipt of the order. See the revised 
regulatory text in provisions Sec. Sec.  112.203(d), 112.204(a), and 
112.205(b).
    For clarification, we are specifying, in new Sec.  112.205(b)(2), 
that a farm that loses its qualified exemption would no longer need to 
comply with the modified requirements in Sec. Sec.  112.6 and 112.7. 
This revision is also consistent with provisions in the PCHF 
regulation.
    (Comment 434) Several comments request longer than the proposed 10 
calendar days to file a written appeal of the order of withdrawal of 
the qualified exemption. Comments cite various reasons, including 
possible issues in mail delivery such that the farmer would have less 
than 10 calendar days, potential need for legal counsel, and time 
needed to gather evidence. Some comments ask us to provide 15 business 
days from date of receipt of the order for the farm to appeal the 
order.
    (Response) We have revised the timeframe for compliance with the 
rule to the date of receipt of an order to withdraw a qualified 
exemption (see our response to Comment 433). Likewise, we conclude that 
it is appropriate to link the timeframe for submitting a written appeal 
of a withdrawal order to the date of receipt of the order, rather than 
to the date the order was issued. Doing so would be consistent with our 
other administrative procedures, such as appeal of an order for 
administrative detention (21 CFR 1.402). Accordingly, we are revising 
the withdrawal provisions to require that a covered farm may request an 
informal hearing by submitting a written appeal in accordance with 
Sec.  112.206 within 15 calendar days from the date of receipt of the 
order. See the revised regulatory text in provisions Sec. Sec.  
112.204(b), 112.206(a)(1), and 112.207(a)(2). We are also revising 
Sec.  112.201(b)(2) to provide for 15 calendar days from the date of 
receipt of the order for a farm to respond in writing to FDA's 
notification. We are also extending the timeframe for the hearing to be 
held within 15 calendar days, rather than the proposed 10 calendar 
days, after the date the appeal is filed to provide more time for the 
farm to prepare for the hearing (see Sec.  112.208(a)). The timeframe 
for the hearing to be held continues to provide for an alternative 
timeframe agreed upon in writing by both the farm and FDA; a farm that 
would have preferred the proposed timeframe of 10 calendar days could 
request that the hearing be held more quickly than 15 calendar days.
    The 15-day timeframe is the same as the timeframe for responding to 
a warning letter. As discussed in Comment 423, circumstances that could 
lead us to withdraw a qualified exemption require prompt action on the 
part of a farm, just as circumstances that lead us to issue a warning 
letter require prompt action.

D. Procedure for Requesting an Informal Hearing (Sec.  112.207)

    (Comment 435) Some comments ask us to guarantee a hearing so that a 
farm can present its case in person before having its qualified 
exemption revoked.
    (Response) We decline this request. We agree that a farm has a 
right to appeal an order to withdraw its qualified exemption, and we 
have provided for a right to appeal.

E. Informal Hearing (Sec.  112.208)

    (Comment 436) One comment states that the two-day time period to 
review and respond to the presiding officer's report is not sufficient.
    (Response) We decline this request. Circumstances that could lead 
us to withdraw a farm's qualified exemption require prompt action on 
the part of the farm, and we conclude that two calendar days is a 
reasonable timeframe, should the farm choose to review and comment on 
the presiding officer's report.
    (Comment 437) Some comments object to our proposal that no party 
shall have the right, under 21 CFR 16.119, to petition FDA for 
reconsideration or a stay of the presiding officer's final decision, 
and ask us to revise proposed Sec.  112.208(c)(6) to specify that a 
farm with a qualified exemption shall have the right to file a motion 
for reconsideration or stay. These comments find insufficient our 
rationale that the circumstances that would lead to a withdrawal merit 
prompt action and that a farm has the opportunity for judicial review 
in accordance with 21 CFR 10.45.
    (Response) We decline this request. In Sec.  112.201(b), we are 
providing an additional mechanism for a farm with a qualified exemption 
to present its view that its exemption should not be withdrawn--i.e., 
by providing advance written notification to the farm if we are 
considering withdrawing an exemption and providing an opportunity for 
the farm to respond before we issue an order to withdraw an exemption. 
In addition, in Sec.  112.213, we are providing an opportunity for 
reinstatement of a qualified exemption that had been withdrawn. We 
believe the multiple opportunities now available to a farm provide 
adequate opportunities for the farm's views to be considered, and 
further mechanisms are not warranted.

F. Circumstances Related to Reinstatement of a Qualified Exemption That 
is Withdrawn (Sec.  112.213)

    (Comment 438) Some comments agree with our tentative conclusion 
that the absence of a specific provision in

[[Page 74526]]

section 418 of the FD&C Act for the reinstatement of an exemption that 
is withdrawn does not preclude us from providing for such a process (79 
FR 58434 at 58466). Other comments disagree with that tentative 
conclusion and assert that Congress crafted the withdrawal provision as 
a ``one strike, you're out'' provision. These comments also assert that 
including the withdrawal provision as a ``one strike, you're out'' 
provision was an essential part of the legislative agreement that 
allowed for adoption of the qualified exemption of a farm. These 
comments also assert that reinstatement would undermine the intent of 
the withdrawal provision, because it would reduce the incentive for 
small farms to ensure that the produce they sell is as safe as 
possible. These comments also assert that a recognized principle of 
statutory interpretation provides that exemptions to statutes should be 
strictly construed, particularly when the statute addresses public 
health and safety, and that FDA is giving the exemption an 
impermissibly broad construction.
    Some comments ask why we believe that a farm deserves a ``second 
bite of the apple'' in light of the understanding (under proposed Sec.  
112.201(b)) that we will first seek to correct problems before 
considering withdrawal. These comments also question at what point a 
farm would apply for reinstatement, and ask why we would allow a farm 
that has already come into compliance with FSMA's requirement to 
implement produce safety standards to abandon those measures in favor 
of reinstating its exempt status. These comments ask us to eliminate 
the proposed provisions allowing for reinstatement.
    Some comments do not support the proposed reinstatement provisions 
when a farm has been directly linked to a foodborne illness outbreak. 
Some comments support the proposed reinstatement provisions only when 
we determine, after finishing an active investigation of a foodborne 
illness outbreak, that the outbreak is not directly linked to the farm 
that had its exemption withdrawn.
    (Response) We disagree that the proposed reinstatement provisions 
would give the exemption an impermissibly broad construction. The 
express statutory language of section 419(f) of the FD&C Act does not 
support the comments' assertion that the withdrawal provision is a 
``one strike, you're out'' provision. We also disagree that 
reinstatement would undermine the intent of the withdrawal provision in 
that it would reduce the incentive for small farms to ensure that the 
produce they sell is as safe as possible. We proposed that a farm would 
need to present data and information to demonstrate that it has 
adequately resolved the problems with the conduct or conditions that 
are material to the safety of the food that would otherwise be covered 
produce grown, harvested, packed or held at the farm, such that 
continued withdrawal of the exemption is not necessary to protect 
public health and prevent or mitigate a foodborne illness outbreak. In 
contrast to the assertion of the comments, we believe that the 
opportunity for reinstatement would be an incentive--not a 
disincentive--for farms that are eligible for a qualified exemption to 
ensure that the produce they sell is safe by continuing to adhere to 
procedures and practices that it develops to comply with the rule. For 
example, if a farm had to implement the provisions of the rule after 
having its exemption withdrawn and realized through testing to comply 
with the water provisions that it needed to apply a day of die-off in 
field before harvesting to come into compliance with the water 
standard, then the farm would likely continue to apply the die-off and 
delay harvesting by a day even after the exemption was reinstated. The 
farm would likely realize that if it did not continue to conduct 
activities that improve the safety of its produce that it might have a 
repeat food safety issue.
    We disagree that we should categorically refuse to consider 
reinstating a qualified exemption if we had withdrawn the exemption 
because a farm had been directly linked to a foodborne illness 
outbreak. First, if information later comes to light to raise 
considerable doubt that a farm with a qualified exemption had, indeed, 
been directly linked to a foodborne illness outbreak, and conduct and 
conditions at the farm do not otherwise warrant withdrawing the farm's 
exemption, it would be appropriate for us to reinstate the farm's 
exemption. Second, as already discussed in this response, we consider 
the reinstatement provisions to be an incentive for a farm to continue 
adhering to procedures and practices that it develops to comply with 
the rule.
    (Comment 439) Some comments that support the reinstatement of a 
withdrawn exemption ask us to establish a timeframe within which FDA 
will reinstate an exemption. Some comments ask us to specify in the 
regulatory text that the reinstatement would occur in a reasonable 
period of time, both in circumstances where FDA has decided on its own 
initiative to reinstate the exemption and in circumstances where a farm 
submits a request for reinstatement. Some comments suggest 10 days is a 
reasonable period of time within which FDA should reinstate an 
exemption.
    (Response) We decline the requests to establish a timeframe for 
reinstatement in the regulatory text. If we determine on our own 
initiative to reinstate an exemption (e.g., because we later determine, 
after finishing the active investigation of a foodborne illness 
outbreak, that the outbreak is not directly linked to the farm), our 
determination would be effective immediately. If we receive a request 
to reinstate a withdrawn exemption, we intend to respond in a 
reasonable time frame consistent with available resources. In some 
cases, we may respond that we need more information in order to 
evaluate your request.
    (Comment 440) Some comments ask us to establish a 1-year 
probationary period before the withdrawn qualified exemption of a farm 
could be fully reinstated.
    (Response) We decline this request. We intend to act on a request 
for reinstatement based on the merits of the data and information 
presented in the request, not after a pre-determined timeframe.
    (Comment 441) One comment believes that the word ``will'' in 
proposed Sec.  112.213(c) implies discretion where none is warranted, 
and suggests changing it to ``shall'' consistent with 112.213(a).
    (Response) We decline this request. Instead, we are replacing the 
word ``shall'' with ``will'' in Sec.  112.213(a) to be consistent with 
Sec.  112.213(c), in the interest of using plain language in drafting 
regulations.

G. Other Comments

    (Comment 442) Several comments ask us to provide clarification 
through guidance, issued for public comment, on a variety of topics 
associated with the withdrawal provisions, including on science-based 
standards that FDA would use when making the final decision to either 
approve or deny an order to withdraw a qualified exemption, and the 
conduct, conditions, or activities that would trigger FDA's actions 
toward withdrawal.
    (Response) We will consider the need for guidance in the future. At 
this time, we consider that withdrawing a qualified exemption of a farm 
would be both rare and dependent upon the circumstances. We need to 
direct our resources to developing guidance on issues that would apply 
more broadly, and more generally, than the withdrawal provisions.

[[Page 74527]]

H. Conforming Amendment to 21 CFR Part 16

    We proposed 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. We received no comments that disagreed with 
this proposed provision, and we are finalizing it as proposed.

XXIV. Comments on Effective and Compliance Dates

A. Effective and Compliance Dates for Part 112

    In the 2013 proposed rule, we proposed that any final rule based on 
proposed part 112 would become effective 60 days after its date of 
publication in the Federal Register, with staggered compliance dates 
based on size of the farm. In addition, for certain specified proposed 
requirements related to agricultural water, we proposed the compliance 
dates would be 2 years beyond the compliance date for the rest of the 
final rule applicable to the farm based on its size.
    Most comments generally support our proposed staggered compliance 
periods based on farm size as well as the extended compliance period 
for the specified water provisions, although some comments suggest 
further extensions whereas others find the proposed compliance periods 
too long. In this section, we discuss comments that express concern 
with the proposed compliance periods, suggest extensions to the 
proposed compliance dates, and/or ask us to clarify how the compliance 
dates will apply.
    After considering comments, we are finalizing the effective date as 
proposed, i.e., 60 days after the publication of this rule. As shown in 
Table 30, we are establishing three sets of compliance dates, all of 
which vary based on size of the farm: one for covered activities 
involving sprouts covered under subpart M, which are subject to all of 
part 112; another for covered activities involving all other produce, 
which are subject to part 112 except subpart M; and another for 
modified requirements relating to the qualified exemption. In the 
second set of compliance dates, we are also providing extended 
compliance dates for certain specified requirements related to 
agricultural water. In the compliance dates relating to the qualified 
exemption, the compliance date for the records that a farm is required 
by Sec.  112.7(b) to maintain to support its eligibility for the 
qualified exemption (e.g., sales receipts and other records as 
applicable) is the effective date of this rule, i.e., January 26, 2016. 
Farms need not comply with the requirement for a written record 
reflecting that the farm has performed an annual review and 
verification of continued eligibility for the qualified exemption until 
the farm's general compliance date, however. In addition, we are 
establishing January 1, 2020, as the compliance date for the modified 
requirement in Sec.  112.6(b)(1).

                                                               Table 30--Compliance Dates
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                      Covered activities involving all other   Farms eligible for a qualified exemption (if applicable)
                                  Covered activities  covered produce (i.e., subject to part -----------------------------------------------------------
                                   involving sprouts          112, except subpart M)
                                     covered under   ----------------------------------------   Compliance date                         Compliance date
      Size of covered farm         subpart M (i.e.,     Compliance date                        for retention of     Compliance date      for all other
                                    subject to all        for certain       Compliance date   records supporting     for modified       requirements in
                                    requirements of        specified         for all other      eligibility in      requirement in    Sec.  Sec.   112.6
                                       part 112)      agricultural water     requirements       Sec.   112.7(b)   Sec.   112.6(b)(1)       and 112.7
                                                          requirements
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                  Time periods starting from the effective date of this rule
                                 ------------------------------------------------------------
Very small business.............  3 years...........  6 years...........  4 years...........  Effective date of   January 1, 2020...  4 years.
                                                                                               rule.
Small business..................  2 years...........  5 years...........  3 years...........  ..................  ..................  3 years.
All other businesses............  1 year............  4 years...........  2 years...........  ..................  ..................  N/A.
--------------------------------------------------------------------------------------------------------------------------------------------------------

    (Comment 443) Some comments state the proposed compliance periods 
are too long and fail to protect public health. One such comment 
suggests we increase efforts to provide technical assistance, 
particularly to small and very small farms to help implement the rule, 
and decrease the length of compliance periods. Another comment suggests 
not delaying compliance period for the standards directed to worker 
health and hygiene because the commenter believes farms already 
implement those provisions to comply with other government regulations.
    Conversely, some other comments find the proposed compliance 
periods unrealistic given, according to these commenters, the 
significant scope and number of changes required and associated 
potential costs. One comment states implementation of the rule will 
require substantial investment and covered farms in its country will 
need additional time to comply with the rule. This comment suggests ten 
years as the compliance period for the water provisions and a minimum 
of four to six years for the remaining provisions.
    Still other comments maintain we should apply a uniform 5-year 
compliance period for all covered farms, instead of the proposed 
staggered compliance periods based on farm sizes. These comments argue 
having different compliance dates for different covered farms will be 
confusing and difficult to manage across different entities in the 
produce supply chain.
    (Response) We intend to prioritize our compliance and enforcement 
efforts. The purpose of tiered compliance dates is to give businesses 
of various sizes time to come into compliance with the rule 
technically, financially, and operationally. FDA and food safety 
partners will be targeting education and outreach efforts to smaller 
businesses that may not be as familiar with our requirements as some of 
the larger farms.
    We conducted extensive stakeholder outreach during the 10-month 
comment period for the 2013 proposed rule. We also provided public 
notice about proposed changes to the farm-related definitions that 
affect the determination of whether a farm is subject to this rule or 
the PCHF regulation, and about specific potential requirements for 
agricultural water. We conducted outreach activities to discuss the new 
and amended proposed provisions in the supplemental notice (see section 
I.E of this document). In addition, we have been collaborating with 
relevant stakeholders to support the development of necessary training 
materials (see section XI of this document) as well as research in the 
areas of agricultural water and raw manure (see sections XIII and XIV, 
respectively, of this document). In light of the extensive outreach 
associated with this rulemaking, we disagree that farms will need more 
than the established compliance periods

[[Page 74528]]

(including the extended compliance periods for certain water provisions 
for covered activities involving covered produce (except sprouts 
covered under subpart M)) to fully adapt their programs to the specific 
requirements of this rule.
    We disagree that we should establish a uniform compliance period 
across all farm sizes. Rather, these compliance periods provide an 
appropriate balance between public health protection and flexibility, 
in light of practical considerations for small and very small 
businesses. Moreover, the extended compliance periods for certain 
specified water provisions are intended to help businesses to develop 
the necessary expertise to implement the specified water requirements, 
and to consider appropriate alternatives and develop adequate 
scientific data or information necessary to support the use of that 
alternative.
1. Effective Date
    Under this rule, the effective date is 60 days after the date of 
publication of this rule in the Federal Register.
2. Compliance Dates for Covered Activities Involving Sprouts Covered 
Under Subpart M
    For covered activities involving sprouts covered under subpart M 
(i.e., all requirements of part 112 apply), the compliance dates are as 
follows: (1) 3 years from the effective date for covered farms that are 
very small businesses; (2) 2 years from the effective date for covered 
farms that are small businesses; and (3) 1 year from the effective date 
for all other covered farms. As discussed in section XVIII.J of this 
document, we conclude these compliance periods are appropriate for 
covered activities involving sprouts covered under subpart M, to 
protect public health. We are also not providing extended compliance 
dates related to certain water requirements. Therefore, the one-to-
three year compliance period applicable to the farm based on its size 
applies for compliance with all requirements of part 112.
3. Compliance Dates for Covered Activities Involving All Other Covered 
Produce
    For covered activities involving all other covered produce (i.e., 
except sprouts covered under subpart M) (i.e., requirements of part 112 
except those of subpart M apply), the compliance dates are as follows: 
(1) 4 years from the effective date (with the exception of compliance 
with certain requirements in subpart E, as discussed in the paragraphs 
that follow)) for covered farms that are very small businesses; (2) 3 
years from the effective date (with the exception of compliance with 
certain requirements in subpart E, as discussed in the paragraphs that 
follow) for covered farms that are small businesses; and (3) 2 years 
from the effective date (with the exception of compliance with certain 
requirements in subpart E, as discussed in the paragraphs that follow) 
for all other covered farms. In addition, for covered activities 
involving covered produce (except sprouts covered under subpart M), we 
are providing the additional flexibility of extended compliance dates 
for certain water-related requirements. As discussed in section XIII.K 
of this document, the compliance period for the following requirements 
is 2 years beyond the compliance date for the rest of this rule 
applicable to the farm based on its size: Sec. Sec.  112.44, 112.45, 
112.46 (except Sec.  112.46(a) and (b)(1)), 112.50(b)(5), 112.50(b)(6), 
112.50(b)(7), and 112.50(b)(8). Accordingly, for these specified 
requirements, the compliance period is 6 years from the effective date 
for covered farms that are very small businesses, 5 years from the 
effective date for covered farms that are small businesses, and 4 years 
from the effective date for all other covered farms.
4. Compliance Dates for Farms Engaged in Covered Activities Involving 
Sprouts Covered Under Subpart M as Well as Other Covered Produce
    For those covered farms that may be engaged in covered activities 
involving both sprouts covered under subpart M as well as other covered 
produce, both sets of compliance dates will apply depending on the 
produce involved in the covered activity. For those aspects of your 
operation relating to covered activities involving sprouts covered 
under subpart M, the compliance dates ranging from 1 to 3 years (based 
on size of your farm) will apply, and for other aspects of your 
operation relating to covered activities involving all other covered 
produce, the compliance dates ranging from 2 to 4 years (based on size 
of the farm) as well as the extended compliance dates ranging from 4 to 
6 years (based on size of the farm) for certain specified water 
requirements will apply.
5. Compliance Dates Applicable to Farms Eligible for a Qualified 
Exemption
    We are establishing three additional compliance dates applicable to 
farms eligible for a qualified exemption. First, as explained in 
section IX.C.7 of this document, the compliance date for the records 
that a farm maintains to support its eligibility for a qualified 
exemption in accordance with Sec. Sec.  112.5 and 112.7 is the 
effective date of this rule, i.e., January 26, 2016. Farms need not 
comply with the requirement for a written record reflecting that the 
farm has performed an annual review and verification of continued 
eligibility for the qualified exemption until the farm's general 
compliance date, however. Second, we are establishing January 1, 2020, 
as the compliance date for the modified requirement of Sec.  
112.6(b)(1). A farm that is eligible for a qualified exemption must 
notify consumers as to the name and complete business address of the 
farm where the food is grown, harvested, packed, and held (see Sec.  
112.6(b)). If a food packaging label is required, the required 
notification must appear prominently and conspicuously on the label of 
the food (see Sec.  112.6(b)(1)). This modified requirement may require 
some farms to update the labels of their packaged food products. For 
many labeling requirements, the time frame for a food establishment to 
comply with new or revised labeling requirements is governed by a 
uniform compliance date (see, e.g., 79 FR 73201, December 10, 2014 and 
77 FR 70885, November 28, 2012). Use of a uniform compliance date 
provides for an orderly and economical industry adjustment to new 
labeling requirements by allowing sufficient lead time to plan for the 
use of existing label inventories and the development of new labeling 
materials. This policy serves consumers' interests as well because the 
cost of multiple short-term label revisions that would otherwise occur 
would likely be passed on to consumers in the form of higher prices. We 
generally announce a uniform compliance date during November or 
December of even-numbered calendar years, and establish the uniform 
compliance date to be January 1 of an upcoming even-numbered calendar 
year. For example, in December, 2014, we issued a final rule 
establishing January 1, 2018, as the uniform compliance date for food 
labeling regulations that are issued between January 1, 2015, and 
December 31, 2016 (79 FR 73201). Likewise, in November, 2012, we issued 
a final rule establishing January 1, 2016, as the uniform compliance 
date for food labeling regulations that are issued between January 1, 
2013, and December 31, 2014 (77 FR 70885, November 28, 2012). These 
uniform compliance dates provide a minimum of 1 year between the date 
when a food labeling regulation is issued and the date when a food

[[Page 74529]]

establishment must comply with that regulation. Following this pattern, 
we intend that the next uniform compliance date will be January 1, 2020 
for food labeling regulations that are issued between January 1, 2017 
and December 31, 2018. A farm that is eligible for a qualified 
exemption would become subject to the modified requirement in Sec.  
112.6(b)(1) during this timeframe--i.e., by December 31, 2018. The 
compliance date that we are establishing for the modified requirement 
of Sec.  112.6(b)(1) (i.e., January 1, 2020) is consistent with the 
approach of a uniform compliance date and will provide such farms with 
more than 1 year from the applicable general compliance date to comply 
with this modified requirement. This compliance date also will provide 
such a farm with more than 4 years to comply with the modified 
requirement relative to the date of publication of this rule. Third, we 
are establishing the compliance dates for all other requirements in 
Sec. Sec.  112.6 and 112.7. As explained under Comment 120, because of 
the difference in the bases for monetary cut-offs established in Sec.  
112.3 and in Sec.  112.5, farms that are eligible for the qualified 
exemption may be either small businesses or very small businesses (as 
defined in Sec.  112.3). Farms eligible for a qualified exemption (in 
accordance with Sec.  112.5) must comply with all other modified 
requirements of Sec. Sec.  112.6 and 112.7 within the compliance 
periods established for either a small business or a very small 
business, whichever is applicable. Based on the monetary cut-offs and 
definitions in Sec.  112.3 and in Sec.  112.5, a farm eligible for a 
qualified exemption must either be a small business or a very small 
business for purposes of this rule.
    (Comment 444) Some comments further request clarification regarding 
the beginning of the compliance period. One comment asks us to account 
for the seasonal nature of farming operations and suggests the 
compliance period should begin on the date of the beginning of the 
first harvest period following the effective date of the rule.
    (Response) See our response to Comment 443 for compliance dates, 
which are based on the size of a covered farm. Setting the compliance 
date for a farm based on the time of harvest, as the comment suggested, 
is challenging because harvest periods will vary greatly based on 
commodity, region, and the farm's practices, which would result in 
widely variable compliance dates. Therefore, we decline this request.

B. Effective Dates for Conforming Changes

    The conforming amendment to part 11 adds a reference to the scope 
of part 11 that the records required under part 112 are not subject to 
part 11. The conforming amendment to part 16 adds a reference to the 
scope of part 16 for new procedures in part 112, subpart R that provide 
a person with an opportunity for a hearing under part 16. These 
conforming amendments are effective on January 26, 2016, the same date 
as the effective date of part 112. We are not establishing compliance 
dates for these conforming amendments. As a practical matter, 
compliance will be implemented by compliance with part 112.

C. Effective Date for Certain Provisions in the PCHF Regulation

    The final human preventive controls rule established six new 
provisions (Sec. Sec.  117.5(k)(2), 117.8, 117.405(c), 
117.410(d)(2)(ii), 117.430(d), and 117.475(c)(13)) that refer to 
provisions in part 112. We announced our intent to publish a document 
in the Federal Register announcing the effective dates of these 
provisions (80 FR 55908). These provisions are effective on January 26, 
2016, the same date as the effective date of part 112.

D. Effective Date for Certain Provisions in the PCAF Regulation

    The final animal preventive controls rule established five new 
provisions (Sec. Sec.  507.12(a)(1)(ii), 507.105(c), 507.110(d)(2)(ii), 
507.130(d), and 507.175(c)(13)) that refer to provisions in part 112. 
We announced our intent to publish a document in the Federal Register 
announcing the effective dates of these provisions (80 FR 56170). These 
provisions are effective on January 26, 2016, the same date as the 
effective date of part 112.

XXV. Executive Order 13175

    In accordance with Executive Order 13175, FDA has consulted with 
tribal government officials. A Tribal Summary Impact Statement has been 
prepared that includes a summary of tribal officials' concerns and how 
FDA has addressed them (Ref. 257). Persons with access to the Internet 
may obtain the Tribal Summary Impact Statement at http://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm334114.htm or at http://www.regulations.gov. Copies of the Tribal Summary Impact Statement also 
may be obtained by contacting the person listed under FOR FURTHER 
INFORMATION CONTACT.

XXVI. Economic Analysis of Impacts

    FDA has examined the impacts of the final 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) (Ref. 142). 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 believes this rule is a significant regulatory action 
under Executive Order 12866.
    The Regulatory Flexibility Act requires Agencies to analyze 
regulatory options that would minimize any significant impact of a rule 
on small entities. Because small farms will bear a large portion of the 
costs, FDA concludes that the final rule will have a significant 
economic impact on a substantial number of small entities.
    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 $144 million, using the most current (2014) Implicit 
Price Deflator for the Gross Domestic Product. FDA expects this final 
rule to result in a 1-year expenditure that will exceed this amount.
    The final analysis conducted in accordance with these Executive 
Orders and statutes is available in the docket for this rulemaking 
(Ref. 142) and at: http://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/.

XXVII. Analysis of Environmental Impact

    FDA has carefully considered the potential environmental effects of 
this action. FDA determined that the proposed action may significantly 
affect the quality of the human environment (21 CFR 25.22(b)) and, 
therefore, an EIS is necessary for the final rule (78 FR 50358, August 
19, 2013). The Draft EIS was released for public comment (80 FR 1852, 
January 14, 2015). FDA considered the comments received on

[[Page 74530]]

the Draft EIS when preparing the Final EIS (see (Ref. 258)). Table 31 
lists Federal Register publications regarding the EIS related to this 
rule.
    FDA's Final EIS and record of decision (Ref. 126) (Ref. 150) may be 
seen in the Division of Dockets Management (see ADDRESSES) between 9 
a.m. and 4 p.m., Monday through Friday.

    Table 31--List of Federal Register Publications Regarding the EIS
------------------------------------------------------------------------
                Description                          Publication
------------------------------------------------------------------------
Proposed Rule, Standards for Growing,       78 FR 3504; January 16,
 Harvesting, Packing, and Holding of         2013.
 Produce for Human Consumption (Note: The
 categorical exclusion statement was cited
 as a reference in this document).
Notice of Intent to Prepare an              78 FR 50358; August 19,
 Environmental Impact Statement for the      2013.
 Proposed Rule.
Extension of Comment Period for the         78 FR 69006; November 18,
 Environmental Impact Statement.             2013.
Public Meeting on Scoping of Environmental  79 FR 13593; March 11, 2014.
 Impact Statement and Extension of Comment
 Period for the Environmental Impact
 Statement.
Draft Environmental Impact Statement        80 FR 1852; January 14,
 Notice of Availability.                     2015.
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XXVIII. Paperwork Reduction Act of 1995

    This rule contains information collection provisions that are 
subject to review by OMB under the Paperwork Reduction Act of 1995 (44 
U.S.C. 3501-3520). A description of these provisions is given in the 
following paragraphs with an estimate of the annual recordkeeping and 
reporting burdens. Included in the estimate is the time for reviewing 
instructions, searching existing data sources, gathering and 
maintaining the data needed, and completing and reviewing each 
collection of information.
    Title: Standards for the Growing, Harvesting, Packing and Holding 
of Produce for Human Consumption.
    Description: Section 105 of FSMA adds section 419 to the FD&C Act 
(21 U.S.C. 350h) requiring FDA to adopt a final regulation to provide 
for minimum science-based standards for fruits and vegetables that are 
RACs based on known safety risks, and directing FDA to set forth in the 
final regulation those 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.
    Description of Respondents: The regulation applies to farms that 
grow produce, meaning fruits and vegetables such as berries, tree nuts, 
herbs, and sprouts. There are 37,404 farms in the United States, 
excluding sprouting operations (Ref. 259), that would be covered by the 
rule. We estimate that there are approximately 285 sprouting operations 
covered by this rule. One section of the regulation also applies to 
some non-farm entities as described in the Third-Party Disclosure 
Burden sub-section of this section.

Exemptions or Eligibility for Exemptions

    The rule includes provisions under which certain farms and produce 
are either not covered or eligible for an exemption and, instead, 
subject to certain modified requirements (see Sec. Sec.  112.2 through 
112.7).

Information Collection Burden Estimate

    The estimated hourly burden is 20,484 one-time hours, and 1,112,641 
annual hours. Furthermore, the estimated one-time third-party 
disclosure burden is 247 hours and the estimated annual third-party 
disclosure burden is 379,705 hours. FDA estimates the burden for this 
information collection as follows:
One-Time Hourly Burden
Agricultural Water--Documentation of Scientific Data
    Section 112.50(b)(3) requires documentation of scientific data or 
information relied on to support the adequacy of a method used to 
satisfy the requirements of Sec. Sec.  112.43(a)(1) and (a)(2). All 
covered farms that would treat their water to achieve a water quality 
requirement in the rule will be required to keep these records. 
Consequently, we estimate that 5,547 farms ([17,840 farms from table 18 
of the RIA x 20 percent that do not rely on die-off] + [3,958 farms 
from table 19 of the RIA x 50 percent that do not re-inspect and 
correct]) would rely on documentation of scientific data or information 
to support the adequacy of a method used to satisfy these requirements. 
It is estimated that one recordkeeper for each of 5,547 farms will 
spend 0.5 hour one-time on this documentation, estimated to consist of 
gathering and maintaining the documentation of scientific data and 
information. Therefore, 5,547 x 0.5 = 2,773 one-time hours to meet the 
requirement of Sec.  112.50(b)(3).
    Section 112.50(b)(5) requires farms that rely on a microbial die-
off or removal rate to determine a time interval between harvest and 
end of storage, including other activities such as commercial washing, 
to achieve a calculated log reduction of generic E. coli in accordance 
with Sec.  112.45(b)(1)(ii) to have documentation of the scientific 
data or information they rely on to support that rate. We estimate that 
25 percent of all farms that rely on die-off, 3,661 (17,840 farms from 
table 18 of the RIA x 80 percent that rely on die-off x 25 percent) 
would generate these records for postharvest die-off intervals. It is 
estimated that two recordkeepers for each of 3,661 farms will spend 0.5 
hour one-time on this documentation, estimated to consist of gathering 
and maintaining the documentation of scientific data and information. 
Therefore, 3,661 x 2 x 0.5 = 3,661 one-time hours to meet the 
requirement of Sec.  112.50(b)(5).
    Section 112.50(b)(8) requires all farms that choose to rely on an 
alternative under Sec.  112.49 to have documentation of the scientific 
data or information they rely on to support that alternative. There are 
four types of alternatives that may be employed according to Sec.  
112.49(a)-(d).
    Section 112.49(a) provides for an alternative microbial quality 
criterion (or criteria) using an appropriate indicator of fecal 
contamination, in lieu of the microbial quality criteria in Sec.  
112.44(b). We estimate that approximately 8,757 farms that irrigate 
(35,029 total farms x 25 percent) will generate these alternative 
records. It is estimated that one recordkeeper (one for each type of 
alternative offered) for each of 8,757 farms will spend 0.5 hour one-
time on this documentation, estimated to consist of gathering and 
maintaining

[[Page 74531]]

the documentation of scientific data and information. Therefore, 8,757 
x 0.5 = 4,376 one-time hours to meet the requirements of Sec. Sec.  
112.50(b)(8) and 112.49(a).
    Section 112.49(b) provides for an alternative microbial die-off 
rate and an accompanying maximum time interval, in lieu of the 
microbial die-off rate and maximum time interval in Sec.  
112.45(b)(1)(i). We estimate that approximately 3,661 farms that rely 
on die-off (14,643 farms that rely on die-off x 25 percent) will 
generate these alternative records. It is estimated that one 
recordkeeper (one for each type of alternative offered) for each of 
3,661 farms will spend 0.5 hour one-time on this documentation, 
estimated to consist of gathering and maintaining the documentation of 
scientific data and information. Therefore, 3,661 x 0.5 = 1,830 one-
time hours to meet the requirements of Sec. Sec.  112.50(b)(8) and 
112.49(b).
    Section 112.49(c) provides for an alternative minimum number of 
samples used in the initial survey for an untreated surface water 
source, in lieu of the minimum number of samples required under Sec.  
112.46(b)(1)(i)(A). We estimate that approximately 2,551 farms that 
utilize surface water (12,554 irrigated farms that use surface water 
less the percentage estimated on public water sources x 20 percent) 
will generate these alternative records. It is estimated that one 
recordkeeper (one for each type of alternative offered) for each of 
2,511 farms will spend 0.5 hour one-time on this documentation, 
estimated to consist of gathering and maintaining the documentation of 
scientific data and information. Therefore, 2,511 x 0.5 = 1,255 one-
time hours to meet the requirements of Sec. Sec.  112.50(b)(8) and 
112.49(c).
    Section 112.49(d) provides for an alternative minimum number of 
samples used in the annual survey for an untreated surface water 
source, in lieu of the minimum number of samples required under Sec.  
112.46(b)(2)(i)(A). We estimate that approximately 2,551 farms that 
utilize surface water (12,554 irrigated farms that use surface water 
less the percentage estimated on public water sources x 20 percent) 
will generate these alternative records. It is estimated that one 
recordkeeper (one for each type of alternative offered) for each of 
2,511 farms will spend 0.5 hour one-time on this documentation, 
estimated to consist of gathering and maintaining the documentation of 
scientific data and information. Therefore, 2,511 x 0.5 = 1,255 one-
time hours to meet the requirements of Sec. Sec.  112.50(b)(8) and 
112.49(c).
    Section 112.50(b)(9) requires all farms that are required to test 
their agricultural water in compliance with Sec.  112.46 to have 
documentation of any analytical methods that they choose to use for 
such testing in lieu of the method that is incorporated by reference in 
Sec.  112.151(a). It is not known how many farms will use other 
analytical methods; however, it is estimated that one recordkeeper will 
work a total of 5 hours one-time to fulfill this requirement, estimated 
as the time needed to search for and collect the documentation of the 
alternative analytical methods.
Sprouts--Establishment of Environmental Monitoring Plan
    Section 112.150(b)(2) requires sprout operations to establish and 
keep a written environmental monitoring plan in accordance with Sec.  
112.145. There is a one-time burden estimated for the establishment of 
this plan and an annual burden estimated for the maintenance of this 
plan. For 74 very small farms, it is estimated that the establishment 
of this environmental monitoring plan (that is, determining the 
information needed to be included in the monitoring plan, including the 
corrective action plan, and developing a template for the plan) record 
is a one-time burden of 7 hours. Therefore, 46 farms x 7 hours = 321 
one-time hours to comply with Sec.  112.150(b)(2). For 60 small farms, 
it is estimated that the establishment of this environmental monitoring 
plan (that is, determining the information needed to be included in the 
monitoring plan, including the corrective action plan, and developing a 
template for the plan) is a one-time burden of 12 hours. Therefore, 37 
farms x 12 hours = 446 one-time hours to comply with Sec.  
112.150(b)(2). For 94 large farms, it is estimated that the 
establishment of this environmental monitoring plan (that is, 
determining the information needed to be included in the monitoring 
plan, including the corrective action plan, and developing a template 
for the plan) is a one-time burden of 17 hours. Therefore, 94 farms x 
17 hours = 1,592 one-time hours to comply with Sec.  112.150(b)(2).
Sprouts--Establishment of Sampling Plan
    Section 112.150(b)(3) requires the documentation of the written 
sampling plan for each production batch of sprouts in accordance with 
Sec.  112.147(a). It is estimated that there is a one-time burden to 
establish this record (that is, determining the information needed to 
be included in the sampling plan, including a corrective action plan, 
and developing a template for the plan) and an annual burden to 
maintain this record (such as updating or making needed changes to the 
plan). For each of 177 sprout farms, it is estimated that the one-time 
burden to establish a written sampling plan is 8 hours. Therefore, 8 
hours x 177 sprout farms = 1,414 one-time burden hours for sprout farms 
to comply with Sec.  112.150(b)(3).
Sprouts--Documentation of Scientific Data
    Section 112.150(b)(5) requires sprout operations to have 
documentation of any analytical methods used in lieu of the methods for 
both environmental testing and batch testing that are incorporated by 
reference in Sec. Sec.  112.152 and 112.153. It is not known how many 
sprout operations will use other analytical methods; however, it is 
estimated that one recordkeeper will work a total of 5 hours one-time 
to fulfill this requirement, estimated as the time needed to search for 
and collect the documentation of the alternative analytical methods.
    In addition, Sec.  112.144(c) requires sprout operations to conduct 
testing for additional pathogens when certain conditions are met, and 
Sec.  112.150(b)(5) requires sprouting operations to have documentation 
of any analytical methods used for such testing because there is no 
specific method for such testing incorporated by reference in Sec.  
112.152 or 112.153. It is not known if or when there will be a 
pathogen(s) meeting the relevant criteria; however, it is estimated 
that one recordkeeper will work a total of 2 hours one-time to fulfill 
this requirement, estimated as the time needed to establish a new 
testing routine. Therefore, we estimate it will take 177 sprouters 353 
records (177 x 2) to fulfill this requirement. At two hours per record, 
this represents a total hourly burden of 707 (353 x 2) to fulfill the 
requirements of Sec. Sec.  112.150(b)(5) and Sec.  112.144(c).
Variances
    Section 112.171 of this rule allows States, tribes, and foreign 
countries to petition FDA for a variance from one or more requirements 
of the rule. Section 112.172 requires the competent authority (i.e., 
the regulatory authority for food safety) for a State, tribe, or a 
foreign country to submit a petition to seek a variance, and Sec.  
112.173 describes what must be included in the Statement of Grounds in 
a petition requesting a variance.
    Data on the number of hours needed to assemble the information 
required for a petition are not available. However, it is estimated 
that it will take one

[[Page 74532]]

recordkeeper 80 hours to compile the relevant information and submit 
the petition to FDA. Furthermore, it is estimated that an additional 
recordkeeper (for example, a supervisor) will evaluate and review the 
petition before it is submitted. We estimate that it will take an 
additional 40 hours for the additional recordkeeper to review the 
submission. Therefore, it is estimated that a State, tribe, or foreign 
government would spend a total of 120 hours on a petition, and this 
would be a one-time burden. Data do not exist to estimate how many 
petitions FDA may get in a year; however, for the purposes of this 
analysis, it is estimated that FDA may receive seven petitions. 
Therefore, 120 hours x 7 petitions = 840 hours to comply with the 
requirements of Sec.  112.173.
Annual Hourly Burden
Qualified Exempt Farms--Documenting Eligibility
    Section 112.7(b) requires farms eligible for the qualified 
exemption in accordance with Sec.  112.5 to establish and keep adequate 
records necessary to demonstrate that the farm satisfies the criteria 
for a qualified exemption, including a written record reflecting that 
the owner, operator, or agent in charge of the farm has performed an 
annual review and verification of the farm's continued eligibility for 
the qualified exemption. We calculate that there are a total of 3,285 
farms that will incur the costs of recordkeeping associated with 
demonstrating qualified exempt status. Therefore, it is estimated that 
one recordkeeper on each of 3,285 farms will spend an average of 0.5 
hours per year on recordkeeping related to documenting eligibility for 
the qualified exemption. Therefore, 3,285 recordkeepers x 0.5 average 
hours per recordkeeper = 1,643 hours to meet the requirements of Sec.  
112.7(b).
Training Records
    Section 112.30(b)(1) requires the establishment and maintenance of 
records of training documenting required training of personnel, 
including the date of training, topics covered, and the persons(s) 
trained. We calculate that there are a total of 24,420 farms (37,404 
total farms x 0.65 not currently keeping training records) that will 
incur the costs of worker training recordkeeping. Therefore, it is 
estimated that one recordkeeper on each of 24,420 farms will spend an 
average of 7.25 hours per year on recordkeeping related to training 
requirements (recording and maintaining the dates and topics of 
training, and person(s) trained) of this final rule. Therefore, 24,420 
recordkeepers x 7.25 average hours per recordkeeper = 177,045 hours to 
meet the requirements of Sec.  112.30(b)(1).
Water Testing
    Water Testing for Zero Detectable Generic E. coli. Section 
112.46(c) requires testing untreated groundwater for the purposes that 
are subject to the requirements of Sec.  112.44(a). We calculate there 
are a total of 26,038 farms (all farms with activities during and after 
harvest, and sprout farms using untreated ground water for growing 
sprouts) that will incur these costs. Therefore, it is estimated that 
two recordkeepers on each of 26,038 farms will spend an average of 0.66 
hours per year on testing water for zero detectable generic E. coli of 
this final rule. Therefore, 26,038 farms x 2 recordkeepers x 0.66 
average hours per recordkeeper = 34,371 hours to meet the requirements 
of Sec. Sec.  112.44(a) and 112.46(c).
    Testing for GM of 126 CFU/100 mL and STV of 410 CFU/100 mL Generic 
E. coli.--Untreated Surface Water Used For Direct Application 
Irrigation of Non-Sprout Covered Produce. Section 112.46(b) requires 
testing each such source of water used for the purposes that are 
subject to the requirements of Sec.  112.44(b). We calculate that there 
are a total of 12,554 farms (all irrigated farms using surface water 
less the percentage estimated on public water sources) that will incur 
these costs. Therefore, it is estimated that 6.29 recordkeepers on each 
of 12,554 farms will spend an average of 0.92 hours per year on Testing 
for GM of 126 CFU/100 mL and STV of 410 CFU/100 mL Generic E. coli--
Untreated Surface Water Used For Direct Application Irrigation of Non-
Sprout Covered Produce of this final rule. Therefore, 12,554 farms x 
6.29 recordkeepers x 0.92 average hours per recordkeeper = 72,648 hours 
to meet the requirements of Sec. Sec.  112.44(b) and 112.46(b).
    Testing for GM of 126 CFU/100 mL and STV of 410 CFU/100 mL Generic 
E. coli--Untreated Ground Water Used For Direct Application Irrigation 
of Non-Sprout Covered Produce. Section 112.46(b) requires testing each 
such source of water used for the purposes that are subject to the 
requirements of Sec.  112.44(b). We calculate that there are a total of 
9,471 farms (all irrigated farms using ground water less the percentage 
estimated on public water sources) that will incur these costs. 
Therefore, it is estimated that 1.4 recordkeepers on each of 9,471 
farms will spend an average of 0.92 hours per year on Testing for GM of 
126 CFU/100 mL and STV of 410 CFU/100 mL Generic E. coli--Untreated 
Ground Water Used For Direct Application Irrigation of Non-Sprout 
Covered Produce of this final rule. Therefore, 9,471 farms x 1.4 
recordkeepers x 0.92 average hours per recordkeeper = 12,198 hours to 
meet the requirements of Sec. Sec.  112.44(b) and 112.46(b).
    Section 112.45 requires water testing as part of certain options 
for corrective steps when the water quality requirements of Sec. Sec.  
112.41 or 112.44 are not met (see Sec. Sec.  112.45(a)(1)(i) and 
112.45(b)(2)). We calculate approximately one percent of all irrigated 
farms will need to conduct these tests; therefore 298 farms (29,763 x 1 
percent) will incur these costs. Therefore, it is estimated that 1 
recordkeeper on each of the 298 farms will spend an average of 0.33 
hours per year on these actions taken when requirements in subpart E 
are not met. Therefore, 298 farms x 1 recordkeeper x 0.33 average hours 
per recordkeeper = 98 hours to meet the requirements of Sec.  112.45.
Recordkeeping Related to Water
    Section 112.50(b)(1) requires the establishment and maintenance of 
records of the Findings of Water System Inspections. We calculate that 
there are 34,369 (all covered farms not currently keeping these 
records) that will incur the costs of water inspection recordkeeping. 
Therefore, it is estimated that 4 recordkeepers on each of 34,369 farms 
will spend an average of 0.8 hours per year on recordkeeping related to 
the Findings of Water System Inspections. Therefore, 34,369 farms x 4 
recordkeepers x 0.8 average hours per recordkeeper = 110,066 hours to 
meet the requirement of Sec.  112.50(b)(1).
    Section 112.50(b)(2) requires the establishment and maintenance of 
Records of Testing for 0 Detectable Generic E. coli. We calculate that 
26,038 farms (see testing discussion) will incur the costs of 
recordkeeping of testing for 0 detectable generic E. coli. Therefore, 
it is estimated that 2 recordkeepers on each of the 26,038 farms will 
spend an average of 0.33 hours per year on recordkeeping related to 
Records of Testing for 0 Detectable Generic E. coli. Therefore, 26,038 
farms x 2 recordkeepers x 0.33 average hours per recordkeeper = 17,185 
hours to meet the requirements of Sec.  112.50(b)(2).
    Section 112.50(b)(2) requires the establishment and maintenance of 
Records of Testing for GM of 126 CFU/100 mL and STV of 410 CFU/100 mL 
Generic E. coli for Untreated Surface Water Used for Direct Application 
Irrigation of Non-Sprout Covered

[[Page 74533]]

Produce. We calculate that 12,554 farms (see previous testing 
discussion) will incur the costs of establishing these records. 
Therefore, it is estimated that 6.29 recordkeepers on each of the 
12,554 farms will spend an average of 0.08 hours per year on this 
recordkeeping. Therefore, 12,554 farms x 6.29 recordkeepers x 0.08 
average hours per recordkeeper = 6,317 hours to meet the requirements 
of Sec.  112.50(b)(2). As noted in response to Comment 229, we are 
exploring the development of an online tool to allow covered farms to 
derive their GM and STV values and appropriate time intervals between 
last irrigation and harvest using the 0.5 log per day die-off rate, 
based on input of sample data, such that farms would not need to 
perform the necessary calculations themselves. We expect such a tool to 
reduce the recordkeeping burden associated with testing of untreated 
surface and untreated ground water (Sec. Sec.  112.46(b) and 
112.50(b)(2)) and time intervals applied between last irrigation and 
harvest (Sec. Sec.  112.45(b)(1) and 112.50(b)(6)). Moreover, FDA will 
not be collecting, storing, or otherwise using any water testing sample 
data that farms enter into the online tool to calculate the GM and STV 
values and develop or update their microbial water quality profiles.
    Section 112.50(b)(2) also requires the establishment and 
maintenance of Records of Testing for GM of 126 CFU/100 mL and STV of 
410 CFU/100 mL Generic E. coli for Untreated Ground Water Used for 
Direct Application Irrigation of Non-Sprout Covered Produce. We 
calculate that 9,471 farms (see previous testing discussion) will incur 
the costs of establishing these records. Therefore, it is estimated 
that 1.4 recordkeepers on each of the 9,471 farms will spend an average 
of 0.08 hours per year on this recordkeeping. Therefore, 9,471 farms x 
1.4 recordkeepers x 0.08 average hours per recordkeeper = 1,061 hours 
to meet the requirements of Sec.  112.50(b)(2). As noted previously, we 
expect development of an online tool to reduce the recordkeeping burden 
associated with testing of untreated surface and untreated ground water 
required under Sec. Sec.  112.46(b) and 112.50(b)(2).
    Section 112.50(b)(4) requires Documentation of Results of 
Monitoring Water Treatment under Sec.  112.43(b). We calculate that 
5,547 farms (the proportion of covered farms that do not use municipal 
water sources and who are not able to use other options to otherwise 
meet quality criteria) will incur the costs of documentation of 
monitoring water treatment. Therefore, it is estimated that 1 
recordkeeper on each of the 5,547 farms will spend an average of 0.98 
hours per year on recordkeeping related to Monitoring Water Treatment. 
Therefore, 5,547 farms x 1 recordkeeper x 0.98 average hours per 
recordkeeper = 5,436 hours to meet the requirements of Sec.  
112.50(b)(4).
    Section 112.50(b)(6) requires documentation of any corrective 
actions taken in accordance with Sec.  112.45. Further, where time 
intervals or (calculated) log reductions are applied in accordance with 
Sec.  112.45(b)(1)(i) and/or (b)(1)(ii), such documentation must 
include the specific time interval or log reduction applied, how the 
time interval or log reduction was determined, and the dates of 
corresponding activities such as the dates of last irrigation and 
harvest, the dates of harvest and end of storage, and/or the dates of 
activities such as commercial washing. We calculate that 14,643 farms 
will incur the costs of documentation of any corrective actions taken 
in accordance with Sec.  112.45, including any time intervals or 
calculated log reductions applied. Therefore, it is estimated that 1 
recordkeeper on each of the 14,643 farms will spend an average of 0.5 
hours per year on recordkeeping related to corrective actions applied. 
Therefore, 14,643 farms x 1 recordkeeper x 0.5 average hours per 
recordkeeper = 7,322 hours to meet the requirements of Sec.  
112.50(b)(6). As noted previously, we expect development of an online 
tool to reduce the recordkeeping burden associated with time intervals 
applied between last irrigation and harvest as required under 
Sec. Sec.  112.45(b)(1) and 112.50(b)(6).
    Section 112.50(b)(7) requires annual documentation of the results 
or certificates of compliance from a Public Water System required under 
Sec.  112.46(a)(1) or (a)(2), if applicable. We calculate that 9,108 
farms (the number of farms using public water systems such as municipal 
water sources) will incur the costs of getting this annual 
documentation from their public water systems. Therefore, it is 
estimated that 1 recordkeeper on each of the 9,108 farms will spend an 
average of 0.33 hours per year on recordkeeping related to 
Documentation from Public Water Systems. Therefore, 9,108 farms x 1 
recordkeeper x 0.33 average hours per recordkeeper = 3,005 hours to 
meet the requirements of Sec.  112.50(b)(7).
Recordkeeping Related to Biological Soil Amendments of Animal Origin
    Section 112.60(b) of this rule specifies the records that covered 
produce farms must establish and keep regarding biological soil 
amendments of animal origin.
    For treated soil amendments acquired from a third party, Sec.  
112.60(b)(1) requires documentation, at least annually, that certain 
criteria have been met, namely that: (1) 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; 
and (2) The biological soil amendment of animal origin has been 
handled, conveyed and stored in a manner and location to minimize the 
risk of contamination by an untreated or in process biological soil 
amendment of animal origin. It is estimated that, for any covered 
produce farm already using treated biological soil amendments from a 
third party, this requirement does not represent a new recordkeeping 
burden. Furthermore, to account for the possibility that this may still 
be a new recordkeeping burden for farms using soil amendments acquired 
from a third party, it is estimated that this requirement will be a new 
recordkeeping burden for an additional 10 percent of remaining covered 
farms (35,029 x 0.10 = 3,503) Therefore, for the purposes of this 
analysis, it is estimated that one recordkeeper for each of a maximum 
of 3,503 farms will spend 0.25 hour annually to meet this requirement, 
estimated to consist of the act of acquiring and maintaining 
documentation. Therefore, 3,503 recordkeepers x 0.25 hour = 876 annual 
hours.
    Section 112.60(b)(2) of this rule requires covered farms to 
document, for a treated biological soil amendment of animal origin 
produced by the covered farm, documentation that process controls (for 
example, time, temperature, and turnings) were achieved. NASS data do 
not exist that would make it possible to estimate how many covered 
farms would choose to produce treated biological soil amendments of 
animal origin for use on their own farms. However, using the USDA's 
1999 Fruit and Vegetable Survey (Ref. 260), it is estimated that 15 
percent of farms that claim to use manure also claim that the manure is 
composted on farm. Furthermore, using data from NASS, the RIA estimates 
that a total of 2,802 covered produce farms use manure (either as a 
component of stabilized compost or raw). For the purposes of this 
analysis, we assume, as an upper bound, that 420 covered farms (2,802 x 
0.15 = 420) choose to produce treated biological soil amendments of 
animal origin for their own farms, and that one recordkeeper for each 
of the 420 farms will spend 0.5 hour annually on this requirement, 
estimated to

[[Page 74534]]

consist of recording confirmation of process control achievement. 
Therefore, 420 recordkeepers x 0.5 hour = 210 annual hours.
Recordkeeping Related to Cleaning and Sanitation
    Section 112.140(b)(1) requires establishment and maintenance of 
records related to cleaning and sanitation, including cleaning worker 
tools and machinery. We calculate that 16,061 very small farms (farms 
that are not currently cleaning and sanitizing tools plus 50 percent of 
farms that are currently cleaning and sanitizing tools) will incur the 
costs of recordkeeping related to cleaning and sanitizing worker tools. 
Therefore, it is estimated that 1 recordkeeper on each of the 16,061 
very small farms will spend an average of 8 hours per year on 
recordkeeping related to cleaning and sanitizing worker tools. 
Therefore, 16,061 very small farms x 1 recordkeeper x 8 average hours 
per recordkeeper = 128,485 hours to meet the requirements of Sec.  
112.140(b)(1). We calculate that 8,635 small and large farms (farms 
that are not currently cleaning and sanitizing tools plus 50 percent of 
farms that are currently cleaning and sanitizing tools) will incur the 
costs of recordkeeping related to cleaning and sanitizing worker tools. 
Therefore, it is estimated that 1 recordkeeper on each of the 8,635 
small and large farms will spend an average of 25 hours per year on 
recordkeeping related to cleaning and sanitizing worker tools. 
Therefore, 8,635 small and large farms x 1 recordkeeper x 25 average 
hours per recordkeeper = 215,871 hours to meet the requirements of 
Sec.  112.140(b)(1).
    Section 112.140(b)(1) also requires establishment and maintenance 
of records related to the cleaning and sanitizing machinery. We 
calculate that 13,156 very small farms (farms that are not currently 
cleaning and sanitizing machinery plus 50 percent of farms that are 
currently cleaning and sanitizing machinery) will incur the costs of 
recordkeeping related to cleaning and sanitizing machinery. Therefore, 
it is estimated that 1 recordkeeper on each of the 13,156 very small 
farms will spend an average of 8 hours per year on recordkeeping 
related to cleaning and sanitizing machinery. Therefore, 13,156 very 
small farms x 1 recordkeeper x 8 average hours per recordkeeper = 
105,248 hours to meet the requirements of Sec.  112.140(b)(1). We 
calculate that 7,073 small and large farms (farms that are not 
currently cleaning and sanitizing machinery plus 50 percent of farms 
that are currently cleaning and sanitizing machinery) will incur the 
costs of recordkeeping related to cleaning and sanitizing machinery. 
Therefore, it is estimated that 1 recordkeeper on each of the 7,073 
small and large farms will spend an average of 25 hours per year on 
recordkeeping related to cleaning and sanitizing machinery. Therefore, 
7,073 small and large farms x 1 recordkeeper x 25 average hours per 
farm = 176,831 hours to meet the requirements of Sec.  112.140(b)(1).
Testing Requirements Related to Sprouts
    Sections 112.144(b) and (c), and 112.147 requires testing spent 
sprout irrigation water from each production batch of sprouts, or if 
such testing is not practicable, each production batch of sprouts at 
the in-process stage for certain pathogens, and Sec.  112.150(b)(4) 
requires recordkeeping related to those tests. This burden is estimated 
to vary across farm size. It is estimated that the burden associated 
with testing is an average of 0.5 hour per test. This time burden is 
estimated to include collecting and preparing the sample. We estimate 
that 33 very small sprout farms produce 3,710 batches, 27 small sprout 
farms produce 2,976 batches, and 68 large sprout farms produce 33,623 
batches. Each farm will have one recordkeeper for each test. Small and 
very small farms will average 125 (50 x 2.5 one each for E. coli and 
Salmonella and 0.5 to reflect the uncertainty associated with 
applicability of testing requirements for additional pathogens) tests 
per farm; large farms will average 558 (223 x 2.5) tests.
    It is estimated that a total of 4,163 batches of sprouts will be 
tested annually for E. coli and Salmonella and, if certain criteria are 
met, emerging pathogens across 33 very small farms. Therefore, 4,163 
tests x 0.5 hour per test = 2,081 annual hours for very small farms to 
comply with Sec. Sec.  112.144(b) and (c) and 112.147. It is estimated 
that a total of 3,375 batches of sprouts will be tested annually across 
27 small farms. Therefore 3,375 tests x 0.5 hour per test = 1,688 
annual hours for small farms to comply with Sec. Sec.  112.144(b) and 
(c) and 112.147. It is estimated that 37,882 batches of sprouts will be 
tested annually across 68 large farms. Therefore, 37,882 test x 0.5 
hour per = 18,941 annual hours for large farms to comply with 
Sec. Sec.  112.144(b) and (c) and 112.147.
    Sections 112.144(a) and 112.145 require testing the sprout growing, 
harvesting, packing, and holding environment for Listeria spp. or L. 
monocytogenes, and Sec.  112.150(b)(4) requires recordkeeping related 
to those tests. This burden is estimated to vary across farm size. It 
is estimated that the burden associated with testing is 0.15 hour to 
collect and prepare each sample. We expect that all firms will sample 
on a monthly basis; it is also expected that the number of samples will 
vary with the size of the farm. We expect very small farms to average 
five samples for each test; small farms to average ten samples per 
test; and large farms to average 15 samples. More samples are expected 
as the size of the farm increases because we estimate that the number 
and location of sampling sites, including appropriate food-contact 
surfaces and non-food-contact surfaces of equipment and other surfaces 
would increase as the farm size increases. It is estimated that one 
recordkeeper from each of the farms will be responsible for collecting 
samples. Therefore, to comply with the requirements of Sec. Sec.  
112.144(a) and 112.145, 33 very small farms will incur a total of 300 
hours of burden annually (33 farms x 5 samples x 12 annual tests x 0.15 
hour per sample); 27 small farms will incur a total of 486 hours 
annually, (27 farms x 10 samples x 12 annual tests x 0.15 hour per 
sample); and 68 large farms will incur a total of 1,835 hours (68 farms 
x 15 samples x 12 annual tests x 0.15 hour per sample).
Recordkeeping Requirements Related to Sprouts
    Section 112.150(b)(1) requires documentation of treatment of seeds 
or beans or documentation of previous seed treatment by a third party. 
This burden is expected to vary across farms; however, this 
documentation burden is estimated to be 0.2 hour per activity, 
estimated to consist of the time needed to record the treatment of 
seeds or beans. It is estimated that one recordkeeper per very small 
farm will document this activity 50 times annually. Therefore, 33 very 
small farms x 50 records = 1,665 records x 0.2 hours per record = 333 
hours for very small farms to comply with Sec.  112.150(b)(1). It is 
estimated that one recordkeeper per small farm will document this 
activity 50 times annually. Therefore, 27 small farms x 50 records = 
1,350 records x 0.2 hours per record = 270 hours for small farms to 
comply with Sec.  112.150(b)(1). It is estimated that one recordkeeper 
per large farm will document this activity about 223 times annually. 
Therefore, 68 large farms x 223 records = 15,153 records x 0.2 hours 
per record = 3,031 hours for large farms to comply with Sec.  
112.150(b)(1).
    Section 112.150(b)(2) requires sprout operations to establish and 
keep a written environmental monitoring plan

[[Page 74535]]

in accordance with Sec.  112.145. It is estimated that there is a one-
time burden to establish this record (that is, determining the 
information needed to be included in the sampling plan and developing a 
template for the plan) and an annual burden to maintain this record 
(such as updating or making needed changes to the plan). For annual 
burdens, it is estimated that each record will require one recordkeeper 
to work 0.15 hour to maintain the environmental monitoring plan (such 
as updating or making needed changes to the plan), across all farm 
sizes. For 46 very small farms, it is estimated that one record will be 
generated annually. Therefore, 46 records x 0.15 hour per record = 7 
total annual hours for very small farms to comply with Sec.  
112.150(b)(2). For 37 small farms, it is estimated that 37 total 
records will be generated annually. Therefore, 37 records x 0.15 hour 
per record = 6 total annual hours for small farms to comply with Sec.  
112.150(b)(2). For 94 large farms, it is estimated that 94 total 
records will be generated annually. Therefore, 94 records x 0.15 hour 
per record = 14 total annual hours for very small farms to comply with 
Sec.  112.150(b)(2).
    Section 112.150(b)(3) requires the documentation of the written 
sampling plan for each production batch of sprouts in accordance with 
Sec.  112.147(a). It is estimated that there is a one-time burden to 
establish this record (that is, determining the information needed to 
be included in the sampling plan and developing a template for the 
plan) and an annual burden to maintain this record (such as updating or 
making needed changes to the plan). For each of 177 sprout farms, it is 
estimated that there will be an annual burden of 1 hour per farm to 
update and make needed changes to the plans. Therefore, 177 sprout 
farms x 1 hour = 177 annual hours for sprout farms to comply with Sec.  
112.150(b)(3).
    Section 112.150(b)(4) requires records of all testing conducted in 
accordance with the requirements of Sec.  112.144 for sprouting 
operations. To comply with this, records of testing for E. coli O157:H7 
and Salmonella spp. and any pathogen meeting the criteria in Sec.  
112.144(c) will be kept, and it is estimated that each such record will 
represent a burden of 0.15 hour, estimated as the time needed to record 
the results of the tests, but the number of records will vary across 
farm sizes. For 33 very small sprouting operations testing for E. coli 
O157:H7 and Salmonella and other pathogens as applicable, it is 
estimated that 2,498 total records will be generated annually (or an 
average of 50.13 per firm x 1.5 to account for the uncertainty 
associated with applicability of testing requirements for additional 
pathogens). Therefore, 2,498 x 0.15 = 375 annual hours for very small 
sprouting operations to comply with Sec.  112.150(b)(4). For 27 small 
sprouting operations it is estimated that 2,025 total records will be 
generated annually (or an average of about 49.6 per sprouting operation 
x 1.5 to account for the uncertainty associated with applicability of 
testing requirements for additional pathogens). Therefore, 2,025 
records x 0.15 hour per record = 304 annual hours for small sprouting 
operations to comply with Sec.  112.150(b)(4) with respect to testing 
for E. coli O157:H7 and Salmonella and other pathogens as applicable. 
For 68 large sprouting operations it is estimated that 22,689 total 
records will be generated annually (or an average of about 222.6 per 
sprouting operation x 1.5 to account for the uncertainty associated 
with applicability of testing requirements for additional pathogens). 
Therefore, 22,689 records x 0.15 hour per record = 3,403 annual hours 
for large sprouting operations to comply with Sec.  112.150(b)(4) with 
respect to testing for E. coli O157:H7 and Salmonella, and other 
pathogens as applicable.
    Section 112.150(b)(4) requires records of all testing conducted in 
accordance with the requirements of Sec. Sec.  112.144 and 112.145 for 
sprouting operations. To comply with this, records of testing for 
Listeria spp. or L. monocytogenes will be kept, and it is estimated 
that each such record will represent a burden of 0.17 hour, estimated 
as the time needed to record the results of the tests, but the number 
of records will vary across sprouting operation sizes. For 33 very 
small sprouting operations, it is estimated that a total of 1,998 
records will be kept annually (or an average of 60 per sprouting 
operation) with respect to testing for Listeria spp. or L. 
monocytogenes. Therefore, 1,998 records x 0.17 hour per record = 340 
total annual hours for small sprouting operations to comply with Sec.  
112.150(b)(4) with respect to testing for Listeria spp. or L. 
monocytogenes. For 27 small farms, it is estimated that a total of 
3,240 records will be kept annually (or an average of 120 per sprouting 
operation). Therefore, 3,240 records x 0.17 hour per record = 551 total 
annual hours for small farms to comply with Sec.  112.150(b)(4) with 
respect to testing for Listeria spp. or L. monocytogenes. For 68 large 
sprouting operations, it is estimated that a total of 12,231 records 
will be kept annually (or an average of 180 per sprouting operation). 
Therefore, 12,231 records x 0.17 hour per record = 2,079 total annual 
hours for large sprouting operations to comply with Sec.  112.150(b)(4) 
with respect to testing for Listeria spp. or L. monocytogenes.
    Section 112.150(b)(6) requires records of corrective actions 
conducted in accordance with the requirements of Sec. Sec.  
112.142(b)(2), 112.146, and 112.148 for sprouting operations. It is 
estimated that all sprouting operations may collectively perform 
approximately 285 corrective actions annually. For each of 285 sprout 
operations, it is estimated that there will be an annual burden of 0.5 
hour per operation to make the required record documenting these 
corrective actions. Therefore, 285 sprout farms x 0.5 hour = 143 annual 
hours for sprout farms to comply with Sec.  112.150(b)(6).

Commercial Processing Exemption Recordkeeping

    Under Sec.  112.2(b)(4), farms relying on the commercial processing 
exemption must establish and maintain records of their required 
disclosures to customers regarding produce that has not been 
commercially processed and the annual written assurances obtained from 
customers regarding such commercial processing. It is estimated that 
Sec.  112.2(b)(4) represents a recordkeeping requirement for 4,568 
entities (4,153 farms that only grow produce exempt from the rule due 
to commercial processing, who would otherwise be subject to the rule x 
an additional 10 percent to account for covered farms relying on this 
exemption for only some of their produce, and other entities that will 
be required to make these records). We estimate that it will take 
approximately 5 minutes to make these records each year. Therefore, 
4,568 entities x 0.08 hour per entity = 365 annual hours to comply with 
Sec.  112.2(b)(4).

[[Page 74536]]

                                 Table 32--Estimated Annual Recordkeeping Burden
                                            [One-time hourly burden]
----------------------------------------------------------------------------------------------------------------
                                                                                                     Operating
                                                                                                     costs in
                                 Number of     Number of      Total       Average                    millions
           21 CFR              recordkeepers    records      records       hourly    Total hours    (related to
                                                                           burden                     testing
                                                                                                     burdens)
----------------------------------------------------------------------------------------------------------------
Agricultural Water--
 Documentation of Scientific
 Data:
    112.50(b)(3)............           5,547            1        5,547          0.5        2,773  ..............
    112.50(b)(5)............           3,661            2        7,322          0.5        3,661  ..............
    112.50(b)(8); 112.49(a).           8,757            1        8,757          0.5        4,379  ..............
    112.50(b)(8); 112.49(b).           3,661            1        3,661          0.5        1,830  ..............
    112.50(b)(8); 112.49(c).           2,511            1        2,511          0.5        1,255  ..............
    112.50(b)(8); 112.49(d).           2,511            1        2,511          0.5        1,255  ..............
    112.50(b)(9)............               1            1            1          5.0            5  ..............
----------------------------------------------------------------------------------------------------------------
Sprouts--Establishment of
 Environmental Monitoring
 Plan:
    112.150(b)(2), Very                   46            1           46          7.0          321  ..............
     Small Farms............
    112.150(b)(2), Small                  37            1           37         12.0          446  ..............
     farms..................
    112.150(b)(2), Large                  94            1           94         17.0        1,592  ..............
     farms..................
Sprouts--Establishment of
 Sampling Plan:
    112.150(b)(3)...........             177            1          177          8.0        1,414  ..............
----------------------------------------------------------------------------------------------------------------
Sprouts--Documentation of
 Scientific Data:
    112.150(b)(5)...........               1            1            1          5.0            5  ..............
    112.150(b)(5); 112.144(c             177            2          353          2.0          707  ..............
     )......................
Variances:
    112.173.................               7            1            7        120.0          840  ..............
                             -----------------------------------------------------------------------------------
        Total One-Time        ..............  ...........  ...........  ...........       20,484             N/A
         Hourly Burden......
----------------------------------------------------------------------------------------------------------------

                                              Annual Hourly Burden
----------------------------------------------------------------------------------------------------------------
                                                              Total       Average                    Operating
           21 CFR                Number of     Number of      annual       hourly    Total hours    costs  (in
                               recordkeepers    records      records       burden                    millions)
----------------------------------------------------------------------------------------------------------------
                          Qualified Exempt Farms--Documenting Eligibility for Exemption
----------------------------------------------------------------------------------------------------------------
112.7(b)....................           3,285            1        3,285          0.5        1,643  ..............
----------------------------------------------------------------------------------------------------------------
                                                    Training
----------------------------------------------------------------------------------------------------------------
112.30(b)(1)................          24,420            1       24,420         7.25      177,045  ..............
----------------------------------------------------------------------------------------------------------------
                                   Testing Requirements for Agricultural Water
----------------------------------------------------------------------------------------------------------------
Records of Testing for 0
 Detectable Generic E. coli:
    112.44(a), 112.46(c)....          26,038            2       52,077          0.7       34,371           $2.48
Testing for GM of 126 CFU/
 100 mL and STV of 410 CFU/
 100 mL Generic E. coli--
 Untreated Surface Water
 Used For Direct Application
 Irrigation of Non-Sprout
 Covered Produce:
    112.44(b), 112.46(b)....          12,554         6.29       78,965         0.92       72,647            5.24
Testing for GM of 126 CFU/
 100 mL and STV of 410 CFU/
 100 mL Generic E. coli--
 Untreated Ground Water Used
 For Direct Application
 Irrigation of Non-Sprout
 Covered Produce:
    112.44(b), 112.46(b)....           9,471            1       13,259          0.9       12,198            0.88
Records of Analytical Test
 Results as Part of
 Corrective Steps:
    112.45..................             298            1          298         0.33           98  ..............
----------------------------------------------------------------------------------------------------------------
Recordkeeping Related to Agricultural Water
----------------------------------------------------------------------------------------------------------------
Findings of Water System
 Inspection:
    112.50(b)(1)............          34,396            4      137,583          0.8      110,066  ..............
Records of Testing for 0
 Detectable Generic E. coli:
    112.50(b)(2)............          26,038            2       52,077         0.33       17,185  ..............

[[Page 74537]]

 
Records of Testing for GM of
 126 CFU/100 mL and STV of
 410 CFU/100 mL Generic E.
 coli--Untreated Surface
 Water Used For Direct
 Application Irrigation of
 Non-Sprout Covered Produce:
    112.50(b)(2)............          12,554         6.29       78,965         0.08        6,317  ..............
Records of Testing for GM of
 126 CFU/100 mL and STV of
 410 CFU/100 mL Generic E.
 coli--Untreated Ground
 Water Used For Direct
 Application Irrigation of
 Non-Sprout Covered Produce:
    112.50(b)(2)............           9,471            1       13,259         0.08        1,061  ..............
Documentation of Monitoring
 Water Treatment
    112.50(b)(4)............           5,547            1        5,547         0.98        5,436  ..............
Documentation of corrective
 actions applied:
112.50(b)(6)................          14,643            1       14,643          0.5        7,322  ..............
Documentation from Public
 Water Systems:
    112.50(b)(7)............           9,108            1        9,108         0.33        3,005  ..............
Recordkeeping Related to
 Soil Amendments:
    112.60(b)(1)............           3,503            1        3,503         0.25          876  ..............
    112.60(b)(2)............             420            1          420         0.50          210  ..............
Recordkeeping Related to
 Cleaning and Sanitation:
    112.140(b)(1) Cleaning            16,061            1       16,061          8.0      128,485  ..............
     worker tools, very
     small farms............
    112.140(b)(1) Cleaning             8,635            1        8,635         25.0      215,871  ..............
     worker tools, small and
     large farms............
    112.140(b)(1) Cleaning            13,156            1       13,156          8.0      105,248  ..............
     machinery, very small
     farms..................
    112.140(b)(1) Cleaning             7,073            1        7,073         25.0      176,831  ..............
     machinery, small and
     large farms............
----------------------------------------------------------------------------------------------------------------
Testing Requirements for Sprouts
----------------------------------------------------------------------------------------------------------------
Testing for E. coli and
 Salmonella and additional
 pathogens as applicable
    112.144(b) and (c),                   33          125        4,163         0.50        2,081            0.15
     112.147, very small
     farms..................
112.144(b) and (c), 112.147,              27          125        3,375         0.50        1,688           $0.12
 small farms................
    112.144(b) and (c),                   68          558       37,882         0.50       18,941            1.37
     112.147, large farms...
Testing for Listeria spp. or
 L. monocytogenes:
    112.144(a), 112.145,                  33           60        1,998         0.15          300            0.02
     very small farms.......
    112.144(a), 112.145,                  27          120        3,240         0.15          486            0.04
     small farms............
    112.144(a), 112.145,                  68          180       12,231         0.15        1,835            0.13
     large farms............
----------------------------------------------------------------------------------------------------------------
Recordkeeping Related to Sprouts
----------------------------------------------------------------------------------------------------------------
Documentation of Treatment
 of Seeds or Beans:
    112.150(b)(1), very                   33           50        1,665         0.20          333  ..............
     small farms............
    112.150(b)(1), small                  27           50        1,350         0.20          270  ..............
     farms..................
    112.150(b)(1), large                  68          223       15,153         0.20        3,031  ..............
     farms..................
Environmental Monitoring
 Plan--Updating:
    112.150(b)(2), very                   46            1           46         0.15            7  ..............
     small farms............
    112.150(b)(2), small                  37            1           37         0.15            6  ..............
     farms..................
    112.150(b)(2), large                  94            1           94         0.15           14  ..............
     farms..................
Sampling Plan--Updating:
    112.150(b)(3)...........             177            1          177         1.00          177  ..............
Records of Testing for
 E.coli and Salmonella and
 additional pathogens as
 applicable:
    112.150(b)(4), very                   33           75        2,498         0.15          375  ..............
     small farms............
    112.150(b)(4), small                  27           75        2,025         0.15          304  ..............
     farms..................
    112.150(b)(4), large                  68          334       22,689         0.15        3,403  ..............
     farms..................
Records of Testing for
 Listeria spp. or L.
 monocytogenes:
    112.150(b)(4), very                   33           60        1,998         0.17          340  ..............
     small farms............
    112.150(b)(4), small                  27          120        3,240         0.17          551  ..............
     farms..................
    112.150(b)(4), large                  68          180       12,231         0.17        2,079  ..............
     farms..................
Records of corrective
 actions:
    112.150(b)(6)...........             285            1          285         0.50          143  ..............
----------------------------------------------------------------------------------------------------------------
Commercial processing exemption recordkeeping
----------------------------------------------------------------------------------------------------------------
Records of disclosures to customers and annual written assurances obtained from customers:......................
----------------------------------------------------------------------------------------------------------------

[[Page 74538]]

 
    112.2(b)(4).............            4568            1        4,568         0.08          365  ..............
                             -----------------------------------------------------------------------------------
        Annual Hourly Burden  ..............  ...........  ...........  ...........    1,112,641  ..............
                             -----------------------------------------------------------------------------------
        Operating Costs.....  ..............  ...........  ...........  ...........  ...........           10.42
----------------------------------------------------------------------------------------------------------------

Third-Party Disclosure Burden
    Under Sec.  112.6(b) certain qualified exempt farms (those that 
would otherwise be covered by the rule but that meet the criteria in 
Sec.  112.5) must comply with certain food labeling or disclosure 
requirements. A total of 21,666 non-sprout farms are estimated to be 
eligible for the qualified exemption in Sec.  112.5. After subtracting 
the number of farms that are not covered by the rule because they have 
annual monetary value of produce sold of $25,000 or less, 3,285 farms 
remain that must comply with Sec.  112.6(b). It is estimated that it 
will take the farm operator approximately 5 minutes to buy and prepare 
one poster board. It is also estimated that the operator will buy 
posters bi-weekly. The total annual time required to buy and prepare a 
poster board is 24 hours [(60 minutes x 24)/60]. Therefore, 3,285 farms 
x 24 annual hours = 78,840 annual hours for these farms to comply with 
the requirement of Sec.  112.6(b).
    It is estimated that farms with other marketing channels will 
provide their name and complete business address on an invoice or 
receipt that accompanies their product. We estimate that a total of 
3,083 farms will incur a cost to comply with this provision. It is 
estimated that it will take a farm operator 5 minutes (0.08 hour) to 
change this template for new invoices, and that this is a one-time 
burden. Therefore, 3,083 x 0.08 hour = about 247 hours to comply with 
Sec.  112.6(b).
    Under Sec.  112.31(b)(2), covered farms are required to instruct 
personnel to notify their supervisor(s) if they are have, or if there 
is a reasonable possibility that they have 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). The number of farms that will need to implement 
this disclosure is based on the estimated number of farms that are not 
currently implementing the requirements imposed by the rule in the RIA. 
It is estimated that one worker from each of 29,175 farms will spend 5 
minutes annually to comply with Sec.  112.31(b)(2), which will consist 
of the employer giving verbal instructions to employees. Therefore, 
29,175 x 5 minutes = 2,334 hours to comply with Sec.  112.31(b)(2).
    Under Sec.  112.33(a), covered farms 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. It is estimated that farms with voluntary food safety 
programs in place will already have practices aligned with this 
provision; therefore no burden is estimated for those farms. After 
subtracting these farms, it is estimated that Sec.  112.33(a) 
represents a third-party disclosure requirement for 35,556 farms. We 
estimate that it will take 8 hours annually for the operator to inform 
visitors of the farm policies, including showing them where the 
restrooms are, and to take reasonable steps to ensure their compliance, 
such as monitoring visitors to ensure they are following the policies 
and procedures. Therefore, 35,556 farms x 8 hours per farm = 284,448 
annual hours to comply with Sec.  112.33(a).
    Under Sec.  112.2(b)(2), farms must disclose in documents 
accompanying produce that is eligible for the commercial processing 
exemption that the food is ``not processed to adequately reduce the 
presence of microorganisms of public health significance.'' It is 
estimated that Sec.  112.2(b)(2) represents a third-party disclosure 
requirement for 4,568 entities (4,153 farms that only grow produce 
exempt from the rule due to commercial processing, who would otherwise 
be subject to the rule x an additional 10 percent to account for 
covered farms relying on this exemption for only some of their produce, 
and other entities that will be required to make these disclosures). We 
estimate that it will take 0.08 hours to provide this statement, and 
the statement will occur on average about 26 times per year (or once a 
week for half of the year). Therefore, 4,568 entities x 0.08 hours per 
entity x 26 shipments = 9,502 annual hours to comply with Sec.  
112.2(b)(2).
    Under Sec.  112.2(b)(3), farms relying on the commercial processing 
exemption must receive certain annual documentation from their buyers 
ensuring that the relevant produce will receive the required 
processing. It is estimated that Sec.  112.2(b)(3) represents a third-
party disclosure requirement for 4,568 entities (the same entities 
described previously regarding Sec.  112.2(b)(2)). We estimate that it 
will take 1 hour to provide this documentation each year. Therefore, 
4,568 entities x 1 hour per entity = 4,568 annual hours to comply with 
Sec.  112.2(b)(3).
    Under Sec.  112.142(b)(2), with certain limited exceptions, if a 
sprouting operation knows or has reason to believe that a lot of seeds 
or beans may be contaminated with a pathogen, the sprouting operation 
must report that information to the seed grower, distributor, supplier, 
or other entity from whom the sprouting operation received the seeds or 
beans. We estimate that this requirement will apply to only a small 
percentage of sprouting operations; therefore this requirement 
represents a burden to 13 sprouting operations (128 x 10 percent). We 
estimate that it will take 1 hour to provide this documentation each 
year. Therefore, 13 sprouting operations x 1 hour per sprouting 
operations = 13 annual hours to comply with Sec.  112.2(b)(3).

[[Page 74539]]

                                Table 33--Estimated Third-Party Disclosure Burden
----------------------------------------------------------------------------------------------------------------
                                                                                      Average
                                     Number of       Number of         Total        burden per
 21 CFR Section  (or FDA Form #)    respondents   responses  per     responses     response  (in    Total hours
                                                     respondent                       hours)
----------------------------------------------------------------------------------------------------------------
                                     One Time Third-Party Disclosure Burden
----------------------------------------------------------------------------------------------------------------
112.6(b) Documentation..........           3,083               1           3,083            0.08             247
                                 -------------------------------------------------------------------------------
    Total One-Time Burden.......  ..............  ..............  ..............  ..............             247
----------------------------------------------------------------------------------------------------------------
                                      Annual Third-Party Disclosure Burden
----------------------------------------------------------------------------------------------------------------
112.6(b) Posting signage........           3,285              24          78,840               1          78,840
112.31(b)(2)....................          29,175               1          29,175            0.08           2,334
112.33(a).......................          35,556               1          35,556               8         284,448
112.2(b)(2).....................           4,568              26         118,776            0.08           9,502
112.2(b)(3).....................           4,568               1           4,568               1           4,568
112.142(b)(2 )..................              13               1              13               1              13
                                 -------------------------------------------------------------------------------
    Total annual burden hours...  ..............  ..............  ..............  ..............         379,705
----------------------------------------------------------------------------------------------------------------

XXIX. Federalism

    FDA has analyzed this final rule in accordance with the principles 
set forth in Executive Order 13132. FDA has determined that the rule 
does not contain policies that have substantial direct effects on the 
States, on the relationship between the National Government and the 
States, or on the distribution of power and responsibilities among the 
various levels of government. Accordingly, FDA has concluded that the 
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.

XXX. References

    The following references have been placed on display in the 
Division of Dockets Management (see ADDRESSES) and may be seen by 
interested persons between 9 a.m. and 4 p.m., Monday through Friday. 
These references are also available electronically at http://www.regulations.gov. We have verified the Web site addresses, but we 
are not responsible for any subsequent changes to Web sites after this 
document publishes in the Federal Register.

1. Food and Drug Administration. ``FDA Actions to Date.'' last 
modified August 17, 2015. accessed October 19, 2015. http://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm359450.htm.
2. Food and Drug Administration. ``Transcript: FSMA Proposed Rules 
On Produce Safety And Preventive Controls for Human Food Facilities. 
Public Meeting, Day One. February 28, 2013.'' available at http://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm336329.htm and in Docket 
No. FDA-2011-N-0920, 2013.
3. Food and Drug Administration. ``Transcript: FSMA Proposed Rules 
On Produce Safety And Preventive Controls For Human Food Facilities. 
Public Meeting, Day Two. March 1, 2013.'' available at http://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm336329.htm and in Docket 
No. FDA-2011-N-0920, 2013.
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233. Weiss, A., and W.P. Hammes. ``Efficacy of Heat Treatment in the 
Reduction of Salmonellae and Escherichia coli O157:H- on Alfalfa, 
Mung bean and Radish Seeds Used for Sprout Production,'' European 
Food Research and Technology 221 (1):187-191, 2005.
234. Bari, M.L., K. Enomoto, D. Nei, and S. Kawamoto. ``Practical 
Evaluation of Mung Bean Seed Pasteurization Method in Japan,'' 
Journal of Food Protection 73 (4):752-757, 2010.
235. Bari, L., K. Enomoto, D. Nei, and S. Kawamoto. ``Scale-Up Seed 
Decontamination Process to Inactivate Escherichia coli O157:H7 and 
Salmonella Enteritidis on Mung Bean Seeds,'' Foodborne Pathogen and 
Disease 7 (1):51-56, 2010.
236. Buchanan, R.L. ``Acquisition of Microbiological Data to Enhance 
Food Safety,'' Journal of Food Protection 63 (6):832-838, 2000.
237. Aguado, V., A.I. Vitas, and I. Garc[iacute]a-Jal[oacute]n. 
``Characterization of Listeria monocytogenes and Listeria innocua 
from a Vegetable Processing Plant by RAPD and REA,'' International 
Journal of Food Microbiology 90:341-347, 2004.
238. Pritchard, T.J., K.J. Flanders, and C.W. Donnelly. ``Comparison 
of the Incidence of Listeria on Equipment Versus Environmental Sites 
Within Dairy Processing Plants,'' International Journal of Food 
Microbiology 26:375-384, 1995.
239. U.S. Department of Agriculture Food Safety and Inspection 
Service. ``FSIS Compliance Guideline: Controlling Listeria 
monocytogenes in Post-lethality Exposed Ready-to-Eat Meat and 
Poultry Products.'' 2012.
240. United Fresh Food Safety and Technology Council. ``Guidance on 
Environmental Monitoring and Control of Listeria for the Fresh 
Produce Industry.'' Washington, DC: United Fresh Produce 
Association, 2013.
241. Centers for Disease Control and Prevention. ``Outbreak of 
Escherichia coli O104: H4 Infections Associated with Sprout 
Consumption--Europe and North America, May-July 2011,'' Morbidity 
and Mortality Weekly Report (MMWR) 62 (50):1029-1031, 2011.
242. Smith, M.A. ``Memorandum to the File--Current State of Testing 
for STECs and the Association of STECs with Fresh Produce, Including 
Sprouts: Communications with Peter Feng, Ph.D., September 2015.'' 
Food and Drug Administration.
243. Tompkin, R.B. ``Control of Listeria monocytogenes in the Food-
Processing Environment,'' Journal of Food Protection 65 (4):709-725, 
2002.
244. Food and Drug Administration. 2008. ``Guidance for Industry: 
Control of Listeria monocytogenes in Refrigerated for Frozen Ready-
To-Eat Foods; Draft Guidance.'' last modified October 30, 2014. 
accessed August 18, 2015. http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/FoodProcessingHACCP/ucm073110.htm.
245. Shakir, F.K., and C. D'Lima. ``Memorandum to the File--Sprout 
Firm Inspection Assignments: Findings on Water Sources Used by U.S. 
Sprout Firms for Irrigation, July 2015.'' Food and Drug 
Administration.
246. Bureau of Indian Affairs U.S. Department of the Interior. 
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October 19, 2015. http://www.bia.gov/WhoWeAre/BIA/OIS/TribalGovernmentServices/TribalDirectory/.
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the Production, Processing, Labeling, and Marketing of Organically 
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250. ``Global GAP.'' accessed October 26, 2015. http://www.globalgap.org/uk_en/.
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Safety Standard.'' last modified February 26, 2015. accessed June 
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Initiative.'' last modified 2014. accessed June 26, 2015. http://www.unitedfresh.org/food-safety/gap-harmonization-initiative/.
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254. Food and Drug Administration. ``FSMA Public Meeting: Focus on 
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Administration Food Safety Modernization: Focus on Implementation 
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Meeting and Establishment of Docket.'' last modified March 24, 2015. 
accessed June 24, 2015. https://www.federalregister.gov/articles/2015/03/24/2015-06656/the-food-and-drug-administration-food-safety-modernization-act-focus-on-implementation-strategy-for.
256. Food and Drug Administration. ``FDA Announces Cooperative 
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September 16, 2014. accessed June 24, 2015. http://www.fda.gov/Food/NewsEvents/ConstituentUpdates/ucm414777.htm.
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for Final Rule on Standards for the Growing, Harvesting, Packing and 
Holding of Produce for Human Consumption.'' 2015.
258. Food and Drug Administration. ``Memorandum to the File--
Response to Comments on Environmental Issues Submitted to the 
Proposed Rule for Produce Safety: Standards for the Growing, 
Harvesting, Packing, and Holding of Produce for Human Consumption, 
October 2015.''
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2012,'' (http://www.agcensus.usda.gov), 2014. Accessed and printed 
on October 29, 2015.
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Services. ``Fruit and Vegetables: Agricultural Practices--1999.'' 
http://purl.access.gpo.gov/GPO/LPS891192001.

Additional References

261. Food and Drug Administration, Memorandum to the File. 
Assessment of International Impacts under EO 12114 for the Final 
Rule: Produce Safety Standards for the Growing, Harvesting, Packing, 
and Holding of Produce for Human Consumption, October 2015.
262. Environmental Protection Agency. Method 1603: Escherichia coli 
(E. coli) in Water by Membrane Filtration Using Modified membrane-
Thermotolerant Escherichia coli Agar (Modified mTEC), December 2009.
263. Food and Drug Administration. Testing Methodology for Listeria 
species or L. monocytogenes in Environmental Samples, Version 1, 
October 2015.
264. Food and Drug Administration. Testing Methodologies for E. coli 
O157:H7 and Salmonella species in Spent Sprout Irrigation Water (or 
Sprouts), Version 1, October 2015.

List of Subjects

21 CFR Part 11

    Administrative practice and procedure, Computer technology, 
Reporting and recordkeeping requirements.

[[Page 74547]]

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, 21 CFR parts 
11, 16, and 112 are amended as follows:

PART 11--ELECTRONIC RECORDS; ELECTRONIC SIGNATURES

0
1. The authority citation for 21 CFR part 11 continues to read as 
follows:

    Authority: 21 U.S.C. 321-393; 42 U.S.C. 262.

0
2. In Sec.  11.1, add paragraph (k) to read as follows:

Sec.  11.1  Scope.

* * * * *
    (k) This part does not apply to records required to be established 
or maintained by part 112 of this chapter. Records that satisfy the 
requirements of part 112 of this chapter, but that also are required 
under other applicable statutory provisions or regulations, remain 
subject to this part.
* * * * *

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

0
3. 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
4. Amend Sec.  16.1 by:
0
a. In paragraph (b)(1), adding an entry in numerical order.
0
b. In paragraph (b)(2), adding 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 (see part 112, subpart P of this chapter).
* * * * *
    (2) * * *
    Sec. Sec.  112.201 through 112.213, (see part 112, subpart R of 
this chapter), relating to withdrawal of a qualified exemption.
* * * * *

0
5. 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 Which farms are subject to the requirements of this part?
112.5 Which farms are 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 my farm is eligible 
for a qualified exemption in accordance with Sec.  112.5?
112.7 What records must I establish and keep if my farm is 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--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--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--Agricultural Water
112.41 What requirements apply to the quality of agricultural water?
112.42 What requirements apply to my agricultural water sources, 
water distribution system, and pooling of water?
112.43 What requirements apply to treating agricultural water?
112.44 What specific microbial quality criteria apply to 
agricultural water used for certain intended uses?
112.45 What measures must I take if my agricultural water does not 
meet the requirements of Sec.  112.41 or Sec.  112.44?
112.46 How often must I test agricultural water that is subject to 
the requirements of Sec.  112.44?
112.47 Who must perform the tests required under Sec.  112.46 and 
what methods must be used?
112.48 What measures must I take for water that I use during 
harvest, packing, and holding activities for covered produce?
112.49 What alternatives may I establish and use in lieu of the 
requirements of this subpart?
112.50 Under this subpart, what requirements apply regarding 
records?
Subpart F--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-H--[Reserved]
Subpart I--Domesticated and Wild Animals
112.81 How do the requirements of this subpart apply to areas where 
covered activities take place?
112.83 What requirements apply regarding grazing animals, working 
animals, and animal intrusion?
112.84 Does this regulation require covered farms to take actions 
that would constitute a ``taking'' of threatened or endangered 
species; to take measures to exclude animals from outdoor growing 
areas; or to destroy animal habitat or otherwise clear farm borders 
around outdoor growing areas or drainages?
Subpart J--[Reserved]
Subpart K--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 immediately prior to and during 
harvest activities?
112.113 How must I handle harvested covered produce during covered 
activities?
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?

[[Page 74548]]

Subpart L--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--Sprouts
112.141 What commodities are subject to this subpart?
112.142 What requirements apply to seeds or beans used to grow 
sprouts?
112.143 What measures must I take for growing, harvesting, packing, 
and holding sprouts?
112.144 What testing must I do during growing, harvesting, packing, 
and holding sprouts?
112.145 What requirements apply to testing the environment for 
Listeria species or L. monocytogenes?
112.146 What actions must I take if the growing, harvesting, 
packing, or holding environment tests positive for Listeria species 
or L. monocytogenes?
112.147 What must I do to collect and test samples of spent sprout 
irrigation water or sprouts for pathogens?
112.148 What actions must I take if the samples of spent sprout 
irrigation water or sprouts test positive for a pathogen?
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.  112.46?
112.152 What methods must I use to test the growing, harvesting, 
packing, and holding environment for Listeria species or L. 
monocytogenes to satisfy the requirements of Sec.  112.144(a)?
112.153 What methods must I use to test spent sprout irrigation 
water (or sprouts) from each production batch of sprouts for 
pathogens to satisfy the requirements of Sec.  112.144(b) and (c)?
Subpart O--Records
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, tribe, 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 information submitted in a petition requesting a 
variance or submitted in comments on such a petition 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
112.192 What is the applicability and status of 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?
112.213 If my qualified exemption is withdrawn, under what 
circumstances would FDA reinstate my qualified exemption?

    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, 
apriums, Artichokes-globe-type, Asian pears, avocados, babacos, 
bananas, Belgian endive, blackberries, blueberries, boysenberries, 
brazil nuts, broad beans, broccoli, Brussels sprouts, burdock, 
cabbages, Chinese cabbages (Bok Choy, mustard, and Napa), cantaloupes, 
carambolas, carrots, cauliflower, celeriac, celery, chayote fruit, 
cherries (sweet), chestnuts, chicory (roots and tops), citrus (such as 
clementine, grapefruit, lemons, limes, mandarin, oranges, tangerines, 
tangors, and uniq fruit), cowpea beans, cress-garden, cucumbers, curly 
endive, currants, dandelion leaves, fennel-Florence, garlic, genip, 
gooseberries, grapes, green beans, guavas, herbs (such as basil, 
chives, cilantro, oregano, and parsley), honeydew, huckleberries, 
Jerusalem artichokes, kale, kiwifruit, kohlrabi, kumquats, leek, 
lettuce, lychees, macadamia nuts, mangos, other melons (such as Canary, 
Crenshaw and Persian), mulberries, mushrooms, mustard greens, 
nectarines, onions, papayas, parsnips, passion fruit, peaches, pears, 
peas, peas-pigeon, peppers (such as bell

[[Page 74549]]

and hot), pine nuts, pineapples, plantains, plums, plumcots, quince, 
radishes, raspberries, rhubarb, rutabagas, scallions, shallots, snow 
peas, soursop, spinach, sprouts (such as alfalfa and mung bean), 
strawberries, summer squash (such as patty pan, yellow and zucchini), 
sweetsop, Swiss chard, taro, tomatoes, turmeric, turnips (roots and 
tops), walnuts, watercress, watermelons, and yams; and
    (2) Mixes of intact fruits and vegetables (such as fruit baskets).

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: Asparagus; beans, black; beans, great 
Northern; beans, kidney; beans, lima; beans, navy; beans, pinto; beets, 
garden (roots and tops); beets, sugar; cashews; cherries, sour; 
chickpeas; cocoa beans; coffee beans; collards; corn, sweet; 
cranberries; dates; dill (seeds and weed); eggplants; figs; ginger; 
hazelnuts; horseradish; lentils; okra; peanuts; pecans; peppermint; 
potatoes; pumpkins; squash, winter; sweet potatoes; and water 
chestnuts.
    (2) Produce that is produced by an individual for personal 
consumption or produced for consumption on the farm or another farm 
under the same management; and
    (3) Produce that is not a raw agricultural commodity.
    (b) Produce is eligible for exemption from the requirements of this 
part (except as noted in paragraphs (b)(1), (2), and (3) of this 
section) under the following conditions:
    (1) The 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 part 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, distilling, or 
otherwise manufacturing/processing produce into products such as sugar, 
oil, spirits, wine, beer or similar products; and
    (2) You must disclose in documents accompanying the produce, in 
accordance with the practice of the trade, that the food is ``not 
processed to adequately reduce the presence of microorganisms of public 
health significance;'' and
    (3) You must either:
    (i) Annually obtain written assurance, subject to the requirements 
of paragraph (b)(6) of this section, from the customer that performs 
the commercial processing described in paragraph (b)(1) of this section 
that the customer has established and is following procedures 
(identified in the written assurance) that adequately reduce the 
presence of microorganisms of public health significance; or
    (ii) Annually obtain written assurance, subject to the requirements 
of paragraph (b)(6) of this section, from your customer that an entity 
in the distribution chain subsequent to the customer will perform 
commercial processing described in paragraph (b)(1) of this section and 
that the customer:
    (A) Will disclose in documents accompanying the food, in accordance 
with the practice of the trade, that the food is ``not processed to 
adequately reduce the presence of microorganisms of public health 
significance''; and
    (B) Will only sell to another entity that agrees, in writing, it 
will either:
    (1) Follow procedures (identified in a written assurance) that 
adequately reduce the presence of microorganisms of public health 
significance; or
    (2) Obtain a similar written assurance from its customer that the 
produce will receive commercial processing described in paragraph 
(b)(1) of this section, and that there will be disclosure in documents 
accompanying the food, in accordance with the practice of the trade, 
that the food is ``not processed to adequately reduce the presence of 
microorganisms of public health significance''; and
    (4) You must establish and maintain documentation of your 
compliance with applicable requirements in paragraphs (b)(2) and (3) in 
accordance with the requirements of subpart O of this part, including:
    (i) Documents containing disclosures required under paragraph 
(b)(2) of this section; and
    (ii) Annual written assurances obtained from customers required 
under paragraph (b)(3) of this section; and
    (5) The requirements of this subpart and subpart Q of this part 
apply to such produce; and
    (6) An entity that provides a written assurance under Sec.  
112.2(b)(3)(i) or (ii) must act consistently with the assurance and 
document its actions taken to satisfy the written assurance.

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 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 any of the requirements of 
this part and, on a rolling basis, the average annual monetary value of 
produce (as defined in paragraph (c) of this section) you sold during 
the previous 3-year period is no more than $250,000.
    (2) Small business. For the purpose of this part, your farm is a 
small business if it is subject to any of the requirements of this part 
and, on a rolling basis, the average annual monetary value of produce 
(as defined in paragraph (c) of this section) you sold during the 
previous 3-year period is no more than $500,000; and your farm is not a 
very small business as provided in paragraph (b)(1) of this section.
    (c) 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 stabilized compost, 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 teas are soil amendments 
for the purposes of this rule.
    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).

[[Page 74550]]

    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 stabilized compost, 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 including animal 
mortalities, 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 stabilized compost 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 on a farm. Covered activity includes manufacturing/
processing of covered produce on a farm, but only to the extent that 
such activities are performed on raw agricultural commodities and only 
to the extent that such activities are within the meaning of ``farm'' 
as defined in this chapter. Providing, acting consistently with, and 
documenting actions taken in compliance with written assurances as 
described in Sec.  112.2(b) are also covered activities. 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 final 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. 
Curing may or may not involve insulation, depending on environmental 
conditions.
    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:
    (i) Primary Production Farm. A Primary Production Farm is an 
operation under one management in one general (but not necessarily 
contiguous) physical location devoted to the growing of crops, the 
harvesting of crops, the raising of animals (including seafood), or any 
combination of these activities. The term ``farm'' includes operations 
that, in addition to these activities:
    (A) Pack or hold raw agricultural commodities;
    (B) Pack or hold processed food, provided that all processed food 
used in such activities is either consumed on that farm or another farm 
under the same management, or is processed food identified in paragraph 
(i)(C)(2)(i) of this definition; and
    (C) Manufacture/process food, provided that:
    (1) All food used in such activities is consumed on that farm or 
another farm under the same management; or
    (2) Any manufacturing/processing of food that is not consumed on 
that farm or another farm under the same management consists only of:
    (i) Drying/dehydrating raw agricultural commodities to create a 
distinct commodity (such as drying/dehydrating grapes to produce 
raisins), and packaging and labeling such commodities, without 
additional manufacturing/processing (an example of additional 
manufacturing/processing is slicing);
    (ii) Treatment to manipulate the ripening of raw agricultural 
commodities (such as by treating produce with ethylene gas), and 
packaging and labeling treated raw agricultural commodities, without 
additional manufacturing/processing; and
    (iii) Packaging and labeling raw agricultural commodities, when 
these activities do not involve additional manufacturing/processing (an 
example of additional manufacturing/processing is irradiation); or
    (ii) Secondary Activities Farm. A Secondary Activities Farm is an 
operation, not located on a Primary Production Farm, devoted to 
harvesting (such as hulling or shelling), packing, and/or holding of 
raw agricultural commodities, provided that the Primary Production 
Farm(s) that grows, harvests, and/or raises the majority of the raw 
agricultural commodities harvested, packed, and/or held by the 
Secondary Activities Farm owns, or jointly owns, a majority interest in 
the Secondary Activities Farm. A Secondary Activities Farm may also 
conduct those additional activities allowed on a Primary Production 
Farm in paragraphs (i)(B) and (C) of this definition.
    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.
    Ground water means the supply of fresh water found beneath the 
Earth's surface, usually in aquifers, which supply wells and springs. 
Ground water does not include any water that meets the definition of 
surface water.
    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 stabilized compost, manure, non-fecal animal 
byproducts or table waste).
    Harvesting applies to farms and farm mixed-type facilities and 
means activities that are traditionally performed on farms for the 
purpose of removing raw agricultural commodities from the place they 
were grown or raised and preparing them for use as food. Harvesting is 
limited to activities performed on raw agricultural commodities, or on 
processed foods created by drying/dehydrating a raw agricultural 
commodity without additional manufacturing/processing, on a farm. 
Harvesting does not include activities that transform a raw 
agricultural commodity into a processed food as defined in section 
201(gg) of the Federal Food, Drug, and Cosmetic Act. Examples of 
harvesting include cutting (or otherwise separating) the edible portion 
of the raw agricultural commodity from the crop plant and removing or 
trimming part of the raw agricultural commodity (e.g., foliage, husks, 
roots or stems). Examples of harvesting also include cooling, field 
coring, filtering, gathering, hulling, removing stems and husks from, 
shelling, sifting, threshing, trimming of outer leaves of, and washing 
raw

[[Page 74551]]

agricultural commodities grown on a farm.
    Hazard means any biological agent that has the potential to cause 
illness or injury in the absence of its control.
    Holding means storage of food and also includes activities 
performed incidental to storage of a food (e.g., activities performed 
for the safe or effective storage of that food, such as fumigating food 
during storage, and drying/dehydrating raw agricultural commodities 
when the drying/dehydrating does not create a distinct commodity (such 
as drying/dehydrating hay or alfalfa)). Holding also includes 
activities performed as a practical necessity for the distribution of 
that food (such as blending of the same raw agricultural commodity and 
breaking down pallets), but does not include activities that transform 
a raw agricultural commodity into a processed food as defined in 
section 201(gg) of the Federal Food, Drug, and Cosmetic Act. Holding 
facilities could include warehouses, cold storage facilities, storage 
silos, grain elevators, and liquid storage tanks.
    Known or reasonably foreseeable hazard means a biological hazard 
that is known to be, or has the potential to be, associated with the 
farm or the food.
    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 include: Baking, boiling, bottling, 
canning, cooking, cooling, cutting, distilling, drying/dehydrating raw 
agricultural commodities to create a distinct commodity (such as 
drying/dehydrating grapes to produce raisins), evaporating, 
eviscerating, extracting juice, formulating, freezing, grinding, 
homogenizing, labeling, milling, mixing, packaging (including modified 
atmosphere packaging), pasteurizing, peeling, rendering, treating to 
manipulate ripening, trimming, washing, or waxing. 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 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 is a farm, 
but that also conducts activities outside the farm definition 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 required, to produce an accurate record of the 
observation or measurement.
    Non-fecal animal byproduct means 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.
    Packing means placing food into a container other than packaging 
the food and also includes activities performed incidental to packing a 
food (e.g., activities performed for the safe or effective packing of 
that food (such as sorting, culling, grading, and weighing or conveying 
incidental to packing or re-packing)), 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 
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 primarily grown and processed for use as meal, flour, baked goods, 
cereals and oils rather than for direct consumption as small, hard 
fruits or seeds (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, and oilseeds (e.g., cotton seed, flax seed, 
rapeseed, soybean, and sunflower seed).
    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 (where the term consumer does not include a business); or a 
restaurant or retail food establishment (as those terms are defined in 
Sec.  1.227) that is located:
    (i) In the same State or the same Indian reservation as the farm 
that produced the food; or
    (ii) Not more than 275 miles from such farm.
    Raw agricultural commodity (RAC) means ``raw agricultural 
commodity'' as defined in section 201(r) of the Federal Food, Drug, and 
Cosmetic Act.
    Sanitize means to adequately treat cleaned surfaces by a process 
that is

[[Page 74552]]

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, stabilized compost, 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.
    Stabilized compost means a stabilized (i.e., finished) biological 
soil amendment produced through a controlled composting process.
    Static composting means a process to produce stabilized compost in 
which air is introduced into biological material (in a pile (or row) 
that may or may not be covered with 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 open to the atmosphere (rivers, 
lakes, reservoirs, streams, impoundments, seas, estuaries, etc.) and 
all springs, wells, or other collectors that are directly influenced by 
surface water.
    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 stabilized compost 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.
    Visitor means any person (other than personnel) who enters your 
covered farm with your permission.
    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, for purposes of this part, means the owner, operator, or agent 
in charge of a covered farm that is subject to some or all of the 
requirements of this part.

Sec.  112.4  Which farms are subject to the requirements of this part?

    (a) Except as provided in paragraph (b) of this section, a farm or 
farm mixed-type facility with an average annual monetary value of 
produce (as ``produce'' is defined in Sec.  112.3(c)) sold during the 
previous 3-year period of more than $25,000 (on a rolling basis), 
adjusted for inflation using 2011 as the baseline year for calculating 
the adjustment, is a ``covered farm'' subject to this part. Covered 
farms subject to this part must comply with all applicable requirements 
of this part when conducting a covered activity on covered produce.
    (b) A farm is not a covered farm if it satisfies the requirements 
in Sec.  112.5 and we have not withdrawn the farm's exemption in 
accordance with the requirements of subpart R of this part.

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

    (a) A farm is 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)) the farm 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 the farm 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)) the farm 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 my farm is 
eligible for a qualified exemption in accordance with Sec.  112.5?

    (a) If your farm is eligible for a qualified exemption in 
accordance with Sec.  112.5, you are subject to the requirements of:
    (1) This subpart (General Provisions);
    (2) Subpart O of this part (Records);
    (3) Subpart Q of this part (Compliance and Enforcement); and
    (4) Subpart R of this part (Withdrawal of Qualified Exemption).
    (b) In addition, you are subject to the following modified 
requirements:
    (1) When a food packaging label is required on food that would 
otherwise 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 (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.

[[Page 74553]]

Sec.  112.7  What records must I establish and keep if my farm is 
eligible for a qualified exemption in accordance with Sec.  112.5?

    If your farm is eligible for a qualified exemption in accordance 
with Sec.  112.5:
    (a) You must establish and keep records required under this 
provision in accordance with the requirements of subpart O of this 
part, except that the requirement in Sec.  112.161(a)(4) for a 
signature or initial of the person performing the activity is not 
required for sales receipts kept in the normal course of business. Such 
receipts must be dated as required under Sec.  112.161(a)(4).
    (b) You must establish and keep adequate records necessary to 
demonstrate that your farm satisfies the criteria for a qualified 
exemption that are described in Sec.  112.5, including a written record 
reflecting that you have performed an annual review and verification of 
your farm's continued eligibility for the qualified exemption.

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 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 certain specific requirements 
of subpart E of this part, as specified in Sec.  112.49, provided that 
you satisfy the requirements of paragraphs (b) and (c) of this section.
    (b) You may establish and use an alternative to any of the 
requirements specified 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, 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.
    (c) Scientific data and information used to support an alternative 
to a requirement specified 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. You are 
not required to notify or seek prior approval from FDA regarding your 
decision to establish or use an alternative under this section.

Subpart C--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, 
and periodically thereafter, at least once annually.
    (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 a 
combination of education, training, and experience necessary 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 must 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 
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 
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--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

[[Page 74554]]

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).
    (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 (or 
other effective surfactant) 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, 
sanitary towel service, electric hand dryers, 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;
    (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;
    (5) Removing or covering hand jewelry that cannot be adequately 
cleaned and sanitized during periods in which covered produce is 
manipulated by hand; and
    (6) Not eating, chewing gum, or using tobacco products in an area 
used for a covered activity (however, drinking beverages is permitted 
in designated areas).

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) 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.
    (b) You must make toilet and hand-washing facilities accessible to 
visitors.

Subpart E--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 requirements apply to my agricultural water sources, 
water distribution system, and pooling of water?

    (a) At the beginning of a growing season, as appropriate, but at 
least once annually, you must inspect all of your agricultural water 
systems, to the extent they are under your control (including water 
sources, water distribution systems, facilities, and equipment), 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 and 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 
distribution systems to the extent they are under your control 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.
    (c) You must adequately maintain all agricultural water sources to 
the extent they are under your control (such as wells). Such 
maintenance includes regularly inspecting each source to identify any 
conditions that are reasonably likely to introduce known or reasonably 
foreseeable hazards into or onto covered produce or food contact 
surfaces; correcting any significant deficiencies (e.g., repairs to 
well cap, well casing, sanitary seals, piping tanks and treatment 
equipment, and control of cross-connections); 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.
    (d) 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 contact of covered produce with pooled 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 requirements apply to treating agricultural water?

    (a) When agricultural water is treated in accordance with Sec.  
112.45:
    (1) Any method you use to treat agricultural water (such as with 
physical treatment, including using a pesticide device as defined by 
the U.S. Environmental Protection Agency (EPA); EPA-registered 
antimicrobial pesticide product; or other suitable method) must be 
effective to make the water safe and of adequate sanitary quality for 
its intended use and/or meet

[[Page 74555]]

the relevant microbial quality criteria in Sec.  112.44, as applicable.
    (2) You must deliver any treatment of agricultural water in a 
manner to ensure that the treated water is consistently safe and of 
adequate sanitary quality for its intended use and/or consistently 
meets the relevant microbial quality criteria in Sec.  112.44, as 
applicable.
    (b) 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 and/or 
consistently meets the relevant microbial quality criteria in Sec.  
112.44, as applicable.

Sec.  112.44  What specific microbial quality criteria apply to 
agricultural water used for certain intended uses?

    (a) When you use agricultural water for any one or more of these 
following purposes, you must ensure there is no detectable generic 
Escherichia coli (E. coli) in 100 milliliters (mL) of agricultural 
water, and you must not use untreated surface water for any of these 
purposes:
    (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 contact food contact surfaces, or to make ice that will 
contact food contact surfaces; and
    (4) Used for washing hands during and after harvest activities.
    (b) When you use agricultural water during growing activities for 
covered produce (other than sprouts) using a direct water application 
method, the following criteria apply (unless you establish and use 
alternative criteria in accordance with Sec.  112.49):
    (1) A geometric mean (GM) of your agricultural water samples of 126 
or less colony forming units (CFU) of generic E. coli per 100 mL of 
water (GM is a measure of the central tendency of your water quality 
distribution); and
    (2) A statistical threshold value (STV) of your agricultural water 
samples of 410 or less CFU of generic E. coli per 100 mL of water (STV 
is a measure of variability of your water quality distribution, derived 
as a model-based calculation approximating the 90th percentile using 
the lognormal distribution).

Sec.  112.45  What measures must I take if my agricultural water does 
not meet the requirements of Sec.  112.41 or Sec.  112.44?

    (a) If you have determined or have reason to believe that your 
agricultural water is not safe or of adequate sanitary quality for its 
intended use as required under Sec.  112.41 and/or if your agricultural 
water does not meet the microbial quality criterion for the specified 
purposes as required under Sec.  112.44(a), you must immediately 
discontinue that use(s), and before you may use the water source and/or 
distribution system again for the intended use(s), you must either:
    (1) Re-inspect the entire affected agricultural water system to the 
extent it is 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 take adequate measures to determine if your changes were 
effective and, as applicable, adequately ensure that your agricultural 
water meets the microbial quality criterion in Sec.  112.44(a); or
    (2) Treat the water in accordance with the requirements of Sec.  
112.43.
    (b) If you have determined that your agricultural water does not 
meet the microbial quality criteria (or any alternative microbial 
quality criteria, if applicable) required under Sec.  112.44(b), as 
soon as practicable and no later than the following year, you must 
discontinue that use, unless you either:
    (1) Apply a time interval(s) (in days) and/or a (calculated) log 
reduction by:
    (i) Applying a time interval between last irrigation and harvest 
using either:
    (A) A microbial die-off rate of 0.5 log per day to achieve a 
(calculated) log reduction of your geometric mean (GM) and statistical 
threshold value (STV) to meet the microbial quality criteria in Sec.  
112.44(b) (or any alternative microbial criteria, if applicable), but 
no greater than a maximum time interval of 4 consecutive days; or
    (B) An alternative microbial die-off rate and any accompanying 
maximum time interval, in accordance with Sec.  112.49; and/or
    (ii) Applying a time interval between harvest and end of storage 
using an appropriate microbial die-off rate between harvest and end of 
storage, and/or applying a (calculated) log reduction using appropriate 
microbial removal rates during activities such as commercial washing, 
to meet the microbial quality criteria in Sec.  112.44(b) (or any 
alternative microbial criteria, if applicable), and any accompanying 
maximum time interval or log reduction, provided you have adequate 
supporting scientific data and information;
    (2) Re-inspect the entire affected agricultural water system to the 
extent it is 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 take adequate measures to determine if your changes were 
effective and adequately ensure that your agricultural water meets the 
microbial quality criteria in Sec.  112.44(b) (or any alternative 
microbial criteria, if applicable); or
    (3) Treat the water in accordance with the requirements of Sec.  
112.43.

Sec.  112.46  How often must I test agricultural water that is subject 
to the requirements of Sec.  112.44?

    (a) There is no requirement to test any agricultural water that is 
subject to the requirements of Sec.  112.44 when:
    (1) You receive water from a Public Water System, as defined under 
the Safe Drinking Water Act (SDWA) regulations, 40 CFR part 141, that 
furnishes water that meets the microbial requirements under those 
regulations or under the regulations of a State (as defined in 40 CFR 
141.2) 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 quality 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) Except as provided in paragraph (a) of this section, you must 
take the following steps for each source of water used for purposes 
that are subject to the requirements of Sec.  112.44(b):
    (1) Conduct an initial survey to develop a microbial water quality 
profile of the agricultural water source.
    (i) The initial survey must be conducted:
    (A) For an untreated surface water source, by taking a minimum 
total of 20 samples of agricultural water (or an alternative testing 
frequency that you establish and use, in accordance with Sec.  112.49) 
over a minimum period of 2 years, but not greater than 4 years.
    (B) For an untreated ground water source, by taking a minimum total 
of four samples of agricultural water during the growing season or over 
a period of 1 year.

[[Page 74556]]

    (ii) The samples of agricultural water must be representative of 
your use of the water and must be collected as close in time as 
practicable to, but prior to, harvest. The microbial water quality 
profile initially consists of the geometric mean (GM) and the 
statistical threshold value (STV) of generic Escherichia coli (E. coli) 
(colony forming units (CFU) per 100 milliliter (mL)) calculated using 
this data set. You must determine the appropriate way(s) in which the 
water may be used based on your microbial water quality profile in 
accordance with Sec.  112.45(b).
    (iii) You must update the microbial water quality profile annually 
as required under paragraph (b)(2) of this section, and otherwise 
required under paragraph (b)(3) of this section.
    (2) Conduct an annual survey to update the microbial water quality 
profile of your agricultural water.
    (i) After the initial survey described in paragraph (b)(1)(i) of 
this section, you must test the water annually to update your existing 
microbial water quality profile to confirm that the way(s) in which the 
water is used continues to be appropriate. You must analyze:
    (A) For an untreated surface water source, a minimum number of five 
samples per year (or an alternative testing frequency that you 
establish and use, in accordance with Sec.  112.49).
    (B) For an untreated ground water source, a minimum of one sample 
per year.
    (ii) The samples of agricultural water must be representative of 
your use of the water and must be collected as close in time as 
practicable to, but prior to, harvest.
    (iii) To update the microbial water quality profile, you must 
calculate revised GM and STV values using your current annual survey 
data, combined with your most recent initial or annual survey data from 
within the previous 4 years, to make up a rolling data set of:
    (A) At least 20 samples for untreated surface water sources; and
    (B) At least 4 samples for untreated ground water sources.
    (iv) You must modify your water use, as appropriate, based on the 
revised GM and STV values in your updated microbial water quality 
profile in accordance with Sec.  112.45(b).
    (3) If you have determined or have reason to believe that your 
microbial water quality profile no longer represents the quality of 
your water (for example, if there are significant changes in adjacent 
land use that are reasonably likely to adversely affect the quality of 
your water source), you must develop a new microbial water quality 
profile reflective of the time period at which you believe your 
microbial water quality profile changed.
    (i) To develop a new microbial water quality profile, you must 
calculate new GM and STV values using your current annual survey data 
(if taken after the time of the change), combined with new data, to 
make up a data set of:
    (A) At least 20 samples for untreated surface water sources; and
    (B) At least 4 samples for untreated ground water sources.
    (ii) You must modify your water use based on the new GM and STV 
values in your new microbial water quality profile in accordance with 
Sec.  112.45(b).
    (c) If you use untreated ground water for the purposes that are 
subject to the requirements of Sec.  112.44(a), you must initially test 
the microbial quality of each source of the untreated ground water at 
least four times during the growing season or over a period of 1 year, 
using a minimum total of four samples collected to be representative of 
the intended use(s). Based on these results, you must determine whether 
the water can be used for that purpose, in accordance with Sec.  
112.45(a). If your four initial sample results meet the microbial 
quality criteria of Sec.  112.44(a), you may test once annually 
thereafter, using a minimum of one sample collected to be 
representative of the intended use(s). You must resume testing at least 
four times per growing season or year if any annual test fails to meet 
the microbial quality criteria in Sec.  112.44(a).

Sec.  112.47  Who must perform the tests required under Sec.  112.46 
and what methods must be used?

    (a) You may meet the requirements related to agricultural water 
testing required under Sec.  112.46 using:
    (1) Test results from your agricultural water source(s) performed 
by you, or by a person or entity acting on your behalf; or
    (2) Data collected by a third party or parties, provided the water 
source(s) sampled by the third party or parties adequately represent 
your agricultural water source(s) and all other applicable requirements 
of this part are met.
    (b) Agricultural water samples must be aseptically collected and 
tested using a method as set forth in Sec.  112.151.

Sec.  112.48  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 its safety and 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 buildup 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.  112.49  What alternatives may I establish and use in lieu of the 
requirements of this subpart?

    Provided you satisfy the requirements of Sec.  112.12, you may 
establish and use one or more of the following alternatives:
    (a) An alternative microbial quality criterion (or criteria) using 
an appropriate indicator of fecal contamination, in lieu of the 
microbial quality criteria in Sec.  112.44(b);
    (b) An alternative microbial die-off rate and an accompanying 
maximum time interval, in lieu of the microbial die-off rate and 
maximum time interval in Sec.  112.45(b)(1)(i);
    (c) An alternative minimum number of samples used in the initial 
survey for an untreated surface water source, in lieu of the minimum 
number of samples required under Sec.  112.46(b)(1)(i)(A); and
    (d) An alternative minimum number of samples used in the annual 
survey for an untreated surface water source, in lieu of the minimum 
number of samples required under Sec.  112.46(b)(2)(i)(A).

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

    (a) You must establish and keep records required under this subpart 
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 all analytical tests conducted 
on agricultural water for purposes of compliance with this subpart;
    (3) Scientific data or information you rely on to support the 
adequacy of a

[[Page 74557]]

method used to satisfy the requirements of Sec.  112.43(a)(1) and (2);
    (4) Documentation of the results of water treatment monitoring 
under Sec.  112.43(b);
    (5) Scientific data or information you rely on to support the 
microbial die-off or removal rate(s) that you used to determine the 
time interval (in days) between harvest and end of storage, including 
other activities such as commercial washing, as applicable, used to 
achieve the calculated log reduction of generic Escherichia coli (E. 
coli), in accordance with Sec.  112.45(b)(1)(ii);
    (6) Documentation of actions you take in accordance with Sec.  
112.45. With respect to any time interval or (calculated) log reduction 
applied in accordance with Sec.  112.45(b)(1)(i) and/or (ii), such 
documentation must include the specific time interval or log reduction 
applied, how the time interval or log reduction was determined, and the 
dates of corresponding activities such as the dates of last irrigation 
and harvest, the dates of harvest and end of storage, and/or the dates 
of activities such as commercial washing);
    (7) Annual documentation of the results or certificates of 
compliance from a public water system required under Sec.  112.46(a)(1) 
or (2), if applicable;
    (8) Scientific data or information you rely on to support any 
alternative that you establish and use in accordance with Sec.  112.49; 
and
    (9) Any analytical methods you use in lieu of the method that is 
incorporated by reference in Sec.  112.151(a).

Subpart F--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 of animal origin used to make the tea have been so processed, 
the water used to make the tea is not untreated surface water, and the 
water used to make the tea has no detectable generic Escherichia coli 
(E. coli) in 100 milliliters (mL) of water.
    (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 of animal origin used to make the tea have not 
been so processed, or the water used to make the tea is untreated 
surface water, or the water used to make the tea has detectable generic 
E. coli in 100 mL of water;
    (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 made with biological materials of animal 
origin 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, water 
distribution systems, and other soil amendments. Agricultural teas that 
are biological soil amendments of animal origin may be used in water 
distribution systems provided that all other requirements of this rule 
are met.
    (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 you know or have reason to believe may 
have 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 (e.g., 
thermal), chemical process (e.g., high alkaline pH), biological process 
(e.g., composting), or a combination of scientifically valid controlled 
physical, chemical and/or biological processes that has been validated 
to satisfy the microbial standard in Sec.  112.55(a) for Listeria 
monocytogenes (L. monocytogenes), Salmonella species, and E. coli 
O157:H7; or
    (b) A scientifically valid controlled physical, chemical, or 
biological process, or a combination of scientifically valid controlled 
physical, chemical, and/or biological processes, that has been 
validated to satisfy the microbial standard in Sec.  112.55(b) for 
Salmonella species and fecal coliforms. Examples of scientifically 
valid controlled biological (e.g., composting) processes that meet the 
microbial standard in Sec.  112.55(b) include:
    (1) Static composting that maintains aerobic (i.e., oxygenated) 
conditions at a minimum of 131[emsp14][deg]F (55 [deg]C) for 3 
consecutive days and is followed by adequate curing; and
    (2) Turned composting that maintains aerobic conditions at a 
minimum of 131[emsp14][deg]F (55 [deg]C) for 15 days (which do not have 
to be consecutive), with a minimum of five turnings, and is followed by 
adequate curing.

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 (a); 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
                                          (or milliliter, if liquid is
                                          being sampled) analytical
                                          portion.

[[Page 74558]]

 
(2) Salmonella species.................  Not detected using a method
                                          that can detect three most
                                          probable numbers (MPN) per 4
                                          grams (or milliliter, if
                                          liquid is being sampled) of
                                          total solids.
(3) E. coli O157:H7....................  Not detected using a method
                                          that can detect 0.3 MPN per 1
                                          gram (or milliliter, if liquid
                                          is being sampled) analytical
                                          portion.
------------------------------------------------------------------------

    (b) Salmonella species are not detected using a method that can 
detect three MPN Salmonella species 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).

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

    (a) You must apply the biological soil amendments of animal origin 
specified in the first column of the table in this paragraph (a) in 
accordance with the application requirements specified in the second 
column of the table in this paragraph (a) and the minimum application 
intervals specified in the third column of the table in this paragraph 
(a).

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

    (b) [Reserved]

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

    (a) You must establish and keep records required under this subpart 
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) For a treated biological soil amendment of animal origin you 
receive from a third party, documentation (such as a Certificate of 
Conformance) at least annually 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; and
    (ii) The biological soil amendment of animal origin has been 
handled, conveyed and stored in a manner and location to minimize the 
risk of contamination by an untreated or in process biological soil 
amendment of animal origin; and
    (2) 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.

Subpart G-H [Reserved]

Subpart I--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:
    (1) When a covered activity takes place in a fully-enclosed 
building; or
    (2) To fish used in aquaculture operations.

Sec.  112.83  What requirements apply regarding grazing animals, 
working animals, and animal intrusion?

    (a) You must take the steps set forth in paragraph (b) of this 
section if under the circumstances there is a reasonable probability 
that grazing animals, working animals, or animal intrusion will 
contaminate covered produce.
    (b) You must:
    (1) Assess the relevant areas used for a covered activity for 
evidence of potential contamination of covered produce as needed during 
the growing season (based on your covered produce; your practices and 
conditions; and your observations and experience); and
    (2) If significant evidence of potential contamination is found 
(such as observation of animals, animal excreta or crop destruction), 
you must evaluate whether the covered produce can be harvested in 
accordance with the requirements of Sec.  112.112 and take measures 
reasonably necessary during growing to assist you later during harvest 
when you must identify, and not harvest, covered produce that is 
reasonably likely to be contaminated with a known or reasonably 
foreseeable hazard.

[[Page 74559]]

Sec.  112.84  Does this regulation require covered farms to take 
actions that would constitute a ``taking'' of threatened or endangered 
species; to take measures to exclude animals from outdoor growing 
areas; or to destroy animal habitat or otherwise clear farm borders 
around outdoor growing areas or drainages?

    No. Nothing in this regulation authorizes the ``taking'' of 
threatened or endangered species as that term is defined by the 
Endangered Species Act (16 U.S.C. 1531-1544) (i.e., to harass, harm, 
pursue, hunt, shoot, wound, kill, trap, capture, or collect, or to 
attempt to engage in any such conduct), in violation of the Endangered 
Species Act. This regulation does not require covered farms to take 
measures to exclude animals from outdoor growing areas, or to destroy 
animal habitat or otherwise clear farm borders around outdoor growing 
areas or drainages.

Subpart J--[Reserved]

Subpart K--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 (except 
when covered produce and excluded produce are placed in the same 
container for distribution); 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 immediately prior to and 
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. At a minimum, identifying and not 
harvesting covered produce that is reasonably likely to be contaminated 
with animal excreta or that is visibly contaminated with animal excreta 
requires a visual assessment of the growing area and all covered 
produce to be harvested, regardless of the harvest method used.

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

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

Sec.  112.114  What requirements apply to dropped covered produce?

    You must not distribute dropped covered produce. Dropped covered 
produce is covered produce that drops to the ground before harvest. 
Dropped covered produce does not include root crops that grow 
underground (such as carrots), crops that grow on the ground (such as 
cantaloupe), or produce that is intentionally dropped to the ground as 
part of harvesting (such as almonds).

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, which includes being:
    (1) Cleanable or designed for single use; and
    (2) Unlikely to support growth or transfer of bacteria.
    (b) If you reuse food-packing material, you must take adequate 
steps to ensure that food contact surfaces are clean, such as by 
cleaning food-packing containers or using a clean liner.

Subpart L--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 microorganisms of public 
health significance. 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 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, when necessary 
and appropriate, sanitize 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

[[Page 74560]]

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 
microorganisms of public health significance, 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 requirements apply to my buildings?

    (a) All of the following requirements apply regarding buildings:
    (1) 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:
    (i) Provide sufficient space for placement of equipment and storage 
of materials;
    (ii) 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
    (2) 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.
    (b) You must implement measures to prevent contamination of your 
covered produce and food contact surfaces in your buildings, as 
appropriate, considering the potential for such contamination through:
    (1) Floors, walls, ceilings, fixtures, ducts, or pipes; and
    (2) Drip or condensate.

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 
at a frequency 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:
    (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, 
sanitary towel service, or electric hand dryers).
    (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 antiseptic hand rubs as a substitute for soap 
(or other effective surfactant) 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

[[Page 74561]]

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, what requirements apply regarding 
records?

    (a) You must establish and keep records required under this subpart 
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--Sprouts

Sec.  112.141  What commodities are subject to this subpart?

    The requirements of this subpart apply to growing, harvesting, 
packing, and holding of all sprouts, except soil- or substrate-grown 
sprouts harvested without their roots.

Sec.  112.142  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) 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) Except as provided in paragraph (c) of this section, if you 
know or have reason to believe that a lot of seeds or beans may be 
contaminated with a pathogen (either because it has been associated 
with foodborne illness; or based on microbial test results, including a 
positive finding of a pathogen in tests required under Sec.  
112.144(b)), you must:
    (1) Discontinue use of all seeds or beans from that lot for sprout 
production and ensure that sprouts grown from that lot of seeds or 
beans do not enter commerce; and
    (2) Report the information (association with illness and/or 
findings of microbial testing) to the seed grower, distributor, 
supplier, or other entity from whom you received the seeds or beans.
    (c) If your reason to believe that a lot of seeds or beans may be 
contaminated was based only on microbial test results:
    (1) You are not required to take the steps set forth in paragraph 
(b)(1) of this section if you treat your lot of seeds or beans with a 
process that is reasonably certain to achieve destruction or 
elimination in the seeds or beans of the most resistant microorganisms 
of public health significance that are likely to occur in the seeds or 
beans; or
    (2) You are not required to take the steps set forth in paragraphs 
(b)(1) and (2) of this section if you later reasonably determine, 
through appropriate followup actions, that the lot of seeds or beans is 
not the source of contamination (e.g., the lot of seeds or beans is not 
the source of a pathogen found in spent sprout irrigation water or 
sprouts).
    (d) 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.
    (e) You must either:
    (1) Treat seeds or beans that will be used to grow sprouts using a 
scientifically valid method to reduce microorganisms of public health 
significance; or
    (2) Rely on prior treatment of seeds or beans conducted by a 
grower, distributor, or supplier of the seeds or beans (whether to 
fulfill this requirement completely or for the purpose of considering 
such prior treatment when applying appropriate additional treatment of 
the seeds or beans at the covered farm immediately before sprouting), 
provided that you obtain documentation (such as a Certificate of 
Conformance) from the grower, distributor, or supplier that:
    (i) The prior treatment was conducted using a scientifically valid 
method to reduce microorganisms of public health significance; and
    (ii) The treated seeds or beans were handled and packaged following 
the treatment in a manner that minimizes the potential for 
contamination.

Sec.  112.143  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, or 
hold sprouts must be cleaned and sanitized before

[[Page 74562]]

contact with sprouts or seeds or beans used to grow sprouts.
    (c) You must conduct testing during growing, harvesting, packing, 
and holding sprouts, as specified in Sec.  112.144.
    (d) You must establish and implement a written environmental 
monitoring plan as specified in Sec.  112.145.
    (e) You must take certain actions if you detect Listeria species or 
L. monocytogenes in the growing, harvesting, packing, or holding 
environment, as specified in Sec.  112.146.
    (f) You must establish and implement a written sampling plan to 
test spent sprout irrigation water or sprouts for pathogens as 
specified in Sec.  112.147.
    (g) You must take certain actions if the samples of spent sprout 
irrigation water or sprouts test positive for a pathogen as specified 
in Sec.  112.148.

Sec.  112.144  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:
    (a) You must test the growing, harvesting, packing, and holding 
environment for Listeria species or L. monocytogenes in accordance with 
the requirements of Sec.  112.145.
    (b) You must either:
    (1) Test spent sprout irrigation water from each production batch 
of sprouts for E. coli O157:H7, Salmonella species, and any pathogens 
meeting the criteria in paragraph (c) of this section, in accordance 
with the requirements of Sec.  112.147; or
    (2) If testing spent sprout irrigation water is not practicable 
(for example, soil-grown sprouts harvested with roots or for 
hydroponically grown sprouts that use very little water), test each 
production batch of sprouts at the in-process stage (i.e., while 
sprouts are still growing) for E. coli O157:H7, Salmonella species, and 
any pathogens meeting the criteria in paragraph (c) of this section, in 
accordance with the requirements of Sec.  112.147.
    (c) In addition to E. coli O157:H7 and Salmonella species, you must 
conduct tests as provided in paragraph (b) of this section for 
additional pathogens when the following conditions are met:
    (1) Testing for the pathogen is reasonably necessary to minimize 
the risk of serious adverse health consequences or death from use of, 
or exposure to, sprouts; and
    (2) A scientifically valid test method for the pathogen is 
available to detect the pathogen in spent sprout irrigation water (or 
sprouts).

Sec.  112.145  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 at what point during production you will 
collect the samples; 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 aseptically collect environmental samples and test 
them for Listeria species or L. monocytogenes using a method as set 
forth in Sec.  112.152.
    (e) Your written environmental monitoring plan must include a 
corrective action plan that, at a minimum, requires you to take the 
actions in Sec.  112.146, and details when and how you will accomplish 
those actions, if the growing, harvesting, packing, or holding 
environment tests positive for Listeria species or L. monocytogenes.

Sec.  112.146  What actions must I take if the growing, harvesting, 
packing, or holding environment tests positive for Listeria species or 
L. monocytogenes?

    You must, at a minimum, 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 sampling and testing to determine whether 
the Listeria species or L. monocytogenes has been eliminated;
    (d) Conduct finished product testing when appropriate;
    (e) Perform any other actions necessary to prevent recurrence of 
the contamination; and
    (f) Take appropriate action to prevent any food that is adulterated 
under section 402 of the Federal Food, Drug, and Cosmetic Act from 
entering into commerce.

Sec.  112.147  What must I do to collect and test samples of spent 
sprout irrigation water or sprouts for pathogens?

    All of the following requirements apply for collecting and testing 
samples of spent sprout irrigation water or sprouts for pathogens as 
required in Sec.  112.144(b):
    (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 pathogens using a method as set forth in Sec.  112.153. You 
must not allow the production batch of sprouts to enter into commerce 
unless the results of the testing of spent sprout irrigation water or 
sprouts are negative for E. coli O157:H7, Salmonella species, and, if 
applicable, a pathogen meeting the criteria in Sec.  112.144(c).
    (c) Your written sampling plan must include a corrective action 
plan that at a minimum, requires you to take the actions in Sec.  
112.148, and details when and how you will accomplish those actions, if 
the samples of spent sprout irrigation water or sprouts test positive 
for E. coli O157:H7, Salmonella species, or a pathogen meeting the 
criteria in Sec.  112.144(c).

Sec.  112.148  What actions must I take if the samples of spent sprout 
irrigation water or sprouts test positive for a pathogen?

    You must, at a minimum, take the following actions if the samples 
of spent sprout irrigation water or sprouts test positive for E. coli 
O157:H7, Salmonella species, or a pathogen meeting the criteria in 
Sec.  112.144(c):
    (a) Take appropriate action to prevent any food that is adulterated 
under

[[Page 74563]]

section 402 of the Federal Food, Drug, and Cosmetic Act from entering 
into commerce;
    (b) Take the steps required in Sec.  112.142(b) with respect to the 
lot of seeds or beans used to grow the affected production batch of 
sprouts (except as allowed under Sec.  112.142(c));
    (c) Clean and sanitize the affected surfaces and surrounding areas; 
and
    (d) Perform any other actions necessary to prevent reoccurrence of 
the contamination.

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

    (a) You must establish and keep records required under this subpart 
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; or alternatively, documentation (such as a Certificate of 
Conformance) from your seed supplier that seeds or beans are treated to 
reduce microorganisms of public health significance and are 
appropriately handled and packaged following the treatment, in 
accordance with the requirements of Sec.  112.142(e);
    (2) Your written environmental monitoring plan in accordance with 
the requirements of Sec.  112.145;
    (3) Your written sampling plan for each production batch of sprouts 
in accordance with the requirements of Sec.  112.147(a) and (c);
    (4) Documentation of the results of all analytical tests conducted 
for purposes of compliance with this subpart;
    (5) Any analytical methods you use in lieu of the methods that are 
incorporated by reference in Sec. Sec.  112.152 and 112.153; and
    (6) Documentation of actions you take in accordance with Sec. Sec.  
112.142(b) and (c), 112.146, and 112.148.

Subpart N--Analytical Methods

Sec.  112.151  What methods must I use to test the quality of water to 
satisfy the requirements of Sec.  112.46?

    You must test the quality of water using:
    (a) The method of analysis published by the U.S. Environmental 
Protection Agency (EPA), ``Method 1603: Escherichia coli (E. coli) in 
Water by Membrane Filtration Using Modified membrane-Thermotolerant 
Escherichia coli Agar (Modified mTEC), EPA-821-R-09-007),'' December, 
2009. The Director of the Federal Register approves this incorporation 
by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. You 
may obtain a copy from EPA, Office of Water (4303T), 1200 Pennsylvania 
Avenue NW., Washington, DC 20460. You may inspect a copy at FDA's Main 
Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, 
MD 20993, 301-796-2039, 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
    (b)(1) A scientifically valid method that is at least equivalent to 
the method of analysis in Sec.  112.151(a) in accuracy, precision, and 
sensitivity; or
    (2) For any other indicator of fecal contamination you may test for 
pursuant to Sec.  112.49(a), a scientifically valid method.

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

    You must test the growing, harvesting, packing, and holding 
environment for Listeria species or L. monocytogenes using:
    (a) The method of analysis described in ``Testing Methodology for 
Listeria species or L. monocytogenes in Environmental Samples,'' 
Version 1, October 2015, U.S. Food and Drug Administration. The 
Director of the Federal Register approves this incorporation by 
reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 5. You may 
obtain a copy from, and/or inspect a copy at, the Division of Produce 
Safety, Center for Food Safety and Applied Nutrition (CFSAN), U.S. Food 
and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 
20740, 240-402-1600; FDA's Main Library, 10903 New Hampshire Ave., 
Bldg. 2, Third Floor, Silver Spring, MD 20993, 301-796-2039; http://www.fda.gov/fsma; 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
    (b) A scientifically valid method that is at least equivalent to 
the method of analysis in Sec.  112.152(a) in accuracy, precision, and 
sensitivity.

Sec.  112.153  What methods must I use to test spent sprout irrigation 
water (or sprouts) from each production batch of sprouts for pathogens 
to satisfy the requirements of Sec.  112.144(b) and (c)?

    You must test spent sprout irrigation water (or sprouts) from each 
production batch for pathogens using:
    (a) For E. coli O157:H7, Salmonella species:
    (1) The method of analysis described in ``Testing Methodologies for 
E. coli O157:H7 and Salmonella species in Spent Sprout Irrigation Water 
(or Sprouts),'' Version 1, October 2015, U.S. Food and Drug 
Administration. The Director of the Federal Register approves this 
incorporation by reference in accordance with 5 U.S.C. 552(a) and 1 CFR 
part 5. You may obtain a copy from, and/or inspect a copy at, the 
Division of Produce Safety, Center for Food Safety and Applied 
Nutrition (CFSAN), Food and Drug Administration, 5100 Paint Branch 
Pkwy., College Park, MD 20740, 240-402-1600; FDA's Main Library, 10903 
New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, MD 20993, 301-
796-2039; http://www.fda.gov/fsma; 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
    (2) A scientifically valid method that is at least equivalent to 
the method of analysis in Sec.  112.153(a)(1) in accuracy, precision, 
and sensitivity; and
    (b) For any other pathogen(s) meeting the criteria in Sec.  
112.144(c), a scientifically valid method.

Subpart O--Records

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

    (a) Except as otherwise specified, 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;

[[Page 74564]]

    (3) Be accurate, legible, and indelible; and
    (4) Be dated, and signed or initialed by the person who performed 
the activity documented.
    (b) Records required under Sec. Sec.  112.7(b), 112.30(b)(2), 
112.50(b)(2), (4), and (6), 112.60(b)(2), 112.140(b)(1) and (2), and 
112.150(b)(1), (4), and (6), 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 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?

    (a) Existing records (e.g., records that are kept to comply with 
other Federal, State, or local regulations, or for any other reason) do 
not need to be duplicated if they contain all of the required 
information and satisfy the requirements of this part. Existing records 
may be supplemented as necessary to include all of the required 
information and satisfy the requirements of this part.
    (b) The information required by this part does not need to be kept 
in one set of records. If existing records contain some of the required 
information, any new information required by this part may be kept 
either separately or combined with the existing records.

Sec.  112.164  How long must I keep records?

    (a)(1) You must keep records required by this part for at least 2 
years past the date the record was created.
    (2) Records that a farm relies on during the 3-year period 
preceding the applicable calendar year to satisfy the criteria for a 
qualified exemption, in accordance with Sec. Sec.  112.5 and 112.7, 
must be retained as long as necessary to support the farm's status 
during the applicable calendar year.
    (b) Records that relate to the general adequacy of the equipment or 
processes or records that relate to analyses, sampling, or action plans 
being used by a farm, including the results of scientific studies, 
tests, and evaluations, must be retained at the farm for at least 2 
years after the use of such equipment or processes, or records related 
to analyses, sampling, or action plans, 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. Records that are established or maintained 
to satisfy the requirements of this part and that meet the definition 
of electronic records in Sec.  11.3(b)(6) of this chapter are exempt 
from the requirements of part 11 of this chapter. Records that satisfy 
the requirements of this part, but that also are required under other 
applicable statutory provisions or regulations, remain subject to 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 of FDA?

    Records obtained by FDA in accordance with 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, Federally-recognized tribe (or ``tribe''), 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, 
tribe, 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 and to provide the same level of public health protection as the 
requirements of this part.

Sec.  112.172  How may a State, tribe, 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 competent authority (i.e., the regulatory authority for food 
safety) for a State, tribe, 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, tribe, 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 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 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.  112.174  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 will be made public as part of the docket 
associated with this request.

[[Page 74565]]

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 (e.g., 
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, tribe, or a foreign country that believes that a 
variance requested by a petition submitted by another State, tribe, 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, tribe, or foreign country that submitted these comments that a 
separate request must be submitted in accordance with Sec. Sec.  
112.172 and 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, tribe, 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 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 on 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 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, tribe, 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, 
tribe, 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 
comments on our determination.
    (3) When applicable, we will:
    (i) Notify in writing any States, tribes, 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, tribes, 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, tribes, or foreign countries in 
which similarly situated persons are located.
    (b) We will consider submissions from affected States, tribes, or 
foreign countries and from other interested parties as follows:
    (1) We will consider requests for hearings by affected States, 
tribes, or foreign countries under part 16 of this chapter.
    (i) If FDA grants a hearing, we will provide the State, tribe, 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 the hearing.
    (ii) If more than one State, tribe, 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?

    A variance(s) may be requested for one or more requirements in 
subparts A through O of this part. Examples of permissible types of 
variances include:
    (a) Variance from the microbial quality criteria when agricultural 
water is used during growing activities for covered produce (other than 
sprouts) using a direct water application method, established in Sec.  
112.44(b);

[[Page 74566]]

    (b) Variance from the microbial die-off rate that is used to 
determine the time interval between last irrigation and harvest, and/or 
the accompanying maximum time interval, established in Sec.  
112.45(b)(1)(i); and
    (c) Variance from the approach or frequency for testing water used 
for purposes that are subject to the requirements of Sec.  112.44(b), 
established in Sec.  112.46(b).

Subpart Q--Compliance and Enforcement

Sec.  112.192  What is the applicability and status of this part?

    (a) The failure to comply with the requirements of this part, 
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.
    (b) The criteria and definitions in this part apply in determining 
whether a food is:
    (1) Adulterated within the meaning of:
    (i) 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
    (ii) 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;
    or
    (2) In violation of section 361 of the Public Health Service Act 
(42 U.S.C. 264).

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, FDA coordinates education and enforcement activities by State, 
territorial, tribal, and local officials by helping develop education, 
training, and enforcement approaches.

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?

    (a) We may withdraw your qualified exemption under Sec.  112.5:
    (1) In the event of an active investigation of a foodborne illness 
outbreak that is directly linked to your farm; or
    (2) If we determine that it is necessary to protect the public 
health and prevent or mitigate a foodborne illness outbreak based on 
conduct or conditions associated with your farm that are material to 
the safety of the food that would otherwise be covered produce grown, 
harvested, packed or held at your farm.
    (b) Before FDA issues an order to withdraw your qualified 
exemption, FDA:
    (1) May consider one or more other actions to protect the public 
health and prevent or mitigate a foodborne illness outbreak, including 
a warning letter, recall, administrative detention, refusal of food 
offered for import, seizure, and injunction;
    (2) Must notify the owner, operator, or agent in charge of the 
farm, in writing, of circumstances that may lead FDA to withdraw the 
exemption, and provide an opportunity for the owner, operator, or agent 
in charge of the farm to respond in writing, within 15 calendar days of 
the date of receipt of the notification, to FDA's notification; and
    (3) Must consider the actions taken by the farm to address the 
circumstances that may lead FDA to withdraw the exemption.

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

    (a) An FDA District Director in whose district the farm is located 
(or, in the case of a foreign farm, the Director of the Office of 
Compliance in the Center for Food Safety and Applied Nutrition), or an 
FDA official senior to either such Director, must approve an order to 
withdraw the exemption before the order is issued.
    (b) Any officer or qualified employee of FDA may issue an order to 
withdraw the exemption after it has been approved in accordance with 
paragraph (a) of this section.
    (c) FDA must issue an order to withdraw the exemption to the owner, 
operator, or agent in charge of the farm.
    (d) FDA must issue an order to withdraw the exemption in writing, 
signed and dated by the officer or qualified employee of FDA who is 
issuing the order.

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 one or both of the following 
circumstances that leads FDA to issue the order:
    (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 either:
    (1) Comply with subparts B through O of this part on the date that 
is 120 calendar days from the date of receipt of the order, or within a 
reasonable timeframe, agreed to by FDA, based on a written 
justification, submitted to FDA, for a timeframe that exceeds 120 
calendar days from the date of receipt of the order; or
    (2) Appeal the order within 15 calendar days of the date of receipt 
of the order in accordance with the requirements of Sec.  112.206.
    (e) A statement that a farm may request that FDA reinstate an 
exemption that was withdrawn by following the procedures in Sec.  
112.213;
    (f) The text of section 419(f) of the Federal Food, Drug, and 
Cosmetic Act and of this subpart;
    (g) 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;
    (h) 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
    (i) The name and the title of the FDA representative who approved 
the order.

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 120 
calendar days of the date from receipt of the order or, if operations 
have ceased and will not resume within 120 calendar days, before the 
beginning of operations in the next growing season, or within a 
reasonable timeframe, agreed to by FDA, based on a written 
justification, submitted to FDA, for a

[[Page 74567]]

timeframe that exceeds 120 calendar days from the date of receipt of 
the order; or
    (b) Appeal the order within 15 calendar days of the date of receipt 
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:
    (1) The owner, operator, or agent in charge of the farm must comply 
with applicable requirements of this part within 120 calendar days from 
the date of receipt of the order, or, if operations have ceased and 
will not resume within 120 calendar days, before the beginning of 
operations in the next growing season, or within a reasonable 
timeframe, agreed to by FDA, based on a written justification, 
submitted to FDA, for a timeframe that exceeds 120 calendar days from 
the date of receipt of the order; and
    (2) The owner, operator, or agent in charge of the farm is no 
longer subject to the modified requirements in Sec. Sec.  112.6 and 
112.7.

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 15 calendar days of the 
date of receipt 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 15 
calendar days of the date of receipt 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 15 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 the 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 a 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), (2), (3), and (5) of this chapter 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.

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.
    (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

[[Page 74568]]

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.

Sec.  112.213  If my qualified exemption is withdrawn, under what 
circumstances would FDA reinstate my qualified exemption?

    (a) If the FDA District Director in whose district your farm is 
located (or, in the case of a foreign farm, the Director of the Office 
of Compliance in the Center for Food Safety and Applied Nutrition) 
determines that the farm has adequately resolved any problems with the 
conduct and conditions that are material to the safety of the food 
produced or harvested at such farm, and that continued withdrawal of 
the exemption is not necessary to protect the public health or prevent 
or mitigate a foodborne illness outbreak, the FDA District Director in 
whose district your farm is located (or, in the case of a foreign farm, 
the Director of the Office of Compliance in the Center for Food Safety 
and Applied Nutrition) will, on his own initiative or at the request of 
a farm, reinstate the qualified exemption.
    (b) You may ask FDA to reinstate a qualified exemption that has 
been withdrawn under the procedures of this subpart as follows:
    (1) Submit a request, in writing, to the FDA District Director in 
whose district your farm is located (or, in the case of a foreign farm, 
the Director of the Office of Compliance in the Center for Food Safety 
and Applied Nutrition); and
    (2) Present, in writing, data and information to demonstrate that 
you have adequately resolved any problems with the conduct and 
conditions that are material to the safety of the food produced and 
harvested at your farm, such that continued withdrawal of the exemption 
is not necessary to protect the public health and prevent or mitigate a 
foodborne illness outbreak.
    (c) If your qualified exemption was withdrawn under Sec.  
112.201(a)(1) and FDA later determines, after finishing the active 
investigation of a foodborne illness outbreak, that the outbreak is not 
directly linked to your farm, FDA will reinstate your qualified 
exemption under Sec.  112.5, and FDA will notify you in writing that 
your exempt status has been reinstated.
    (d) If your qualified exemption was withdrawn under Sec.  
112.201(a)(1) and (2) and FDA later determines, after finishing the 
active investigation of a foodborne illness outbreak, that the outbreak 
is not directly linked to your farm, FDA will inform you of this 
finding, and you may ask FDA to reinstate your qualified exemption 
under Sec.  112.5, in accordance with the requirements of paragraph (b) 
of this section.

    Dated: October 30, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-28159 Filed 11-13-15; 8:45 am]
 BILLING CODE 4164-01-P