[Federal Register Volume 80, Number 228 (Friday, November 27, 2015)]
[Rules and Regulations]
[Pages 74354-74568]
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
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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
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Time periods starting from the effective date of this rule
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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.
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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
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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
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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.
------------------------------------------------------------------------
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.
4. Food and Drug Administration. ``Transcript: FSMA Proposed Rules
On Produce Safety And Preventive Controls For Human Food Facilities.
Public Meeting, Day One. March 11, 2013.'' available at http://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm336329.htm and in Docket
No. FDA-2011-N-0920, 2013.
5. Food and Drug Administration. ``Transcript: FSMA Proposed Rules
On Produce Safety And Preventive Controls for Human Food Facilities.
Public Meeting, Day Two. March 12, 2013.'' available at http://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm339097.htm and in Docket
No. FDA-2011-N-0920, 2013.
6. Food and Drug Administration. ``Transcript: FSMA Proposed Rules
On Produce Safety And Preventive Controls For Human Food Facilities.
Public Meeting, Day One. March 27, 2013.'' available at http://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm339096.htm and in Docket
No. FDA-2011-N-0920, 2013.
7. Food and Drug Administration. ``Transcript: FSMA Proposed Rules
On Produce Safety And Preventive Controls For Human Food Facilities.
Public Meeting, Day Two. March 28, 2013.'' available at http://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm339096.htm and in Docket
No. FDA-2011-N-0920, 2013.
8. Food and Drug Administration. ``FSMA Supplemental Proposals
Records of Outreach Sessions--September 29, 2014--December 15,
2014.'' Available in Docket No. FDA-2011-N-0920.
9. Taylor, M. 2013. ``Statement From FDA Deputy Commissioner for
Foods and Veterinary Medicine, Michael Taylor, on Key Provisions of
the Proposed FSMA Rules Affecting Farmers.'' last modified September
19, 2014. accessed October 20, 2015. http://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm379397.htm.
10. Taylor, M. ``Your Input Is Bringing Change to Food Safety
Rules.'' last modified December 19, 2013. accessed October 20, 2015.
http://blogs.fda.gov/fdavoice/index.php/2013/12/your-input-is-bringing-change-to-food-safety-rules.
11. Food and Drug Administration. ``Current Good Manufacturing
Practice, Hazard Analysis, and Risk-Based Preventive Controls for
Human Food; Final Rule.'' Federal Register. 80 FR 55908, September
17, 2015. available at https://www.federalregister.gov/articles/2015/09/17/2015-21920/current-good-manufacturing-practice-hazard-analysis-and-risk-based-preventive-controls-for-human and Docket No.
FDA-2011-N-0920.
12. Food and Drug Administration. ``President's FY 2016 Budget
Request for FSMA: Education and Technical Assistance for Industry.''
last modified March 5, 2015. accessed October 14, 2015. http://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm436153.htm.
13. Food and Drug Administration. 2015. ``FDA's Strategy for FSMA
Training.'' last modified October 06, 2015. accessed October 20,
2015. http://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm461513.htm.
14. Food and Drug Administration. 1998. ``Guidance for Industry:
Guide to Minimize Microbial Food Safety Hazards for Fresh Fruits and
Vegetables.'' last modified May 13, 2015. accessed June 23, 2015.
http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/ucm064574.htm.
[[Page 74540]]
15. Nesse, L.L., T. L[Oslash]vold, B. Bergsj[Oslash], K. Nordby, C.
Wallace, and G. Holstad. ``Persistence of Orally Administered
Salmonella enterica Serovars Agona and Montevideo in Atlantic Salmon
(Salmo salar L.),'' Journal of Food Protection 68 (7):1336-1339,
2005.
16. Gaertner, J., P.E. Wheeler, S. Obafemi, J. Valdez, M.R.
Forstner, T.H. Bonner, and D. Hahn. ``Detection of Salmonellae from
Fish in a Natural River System,'' Journal of Aquatic Animal Health
20 (3):150-157, 2008.
17. Buras, N., L. Luek, and S. Niv. ``Reactions of Fish to
Microorganisms in Wastewater,'' Applied and Environmental
Microbiology 50 (4):989-995, 1985.
18. Pal, D., and C.D. Gupta. ``Nonspecific Defense Mechanisms of
Cirrhinus mrigala against Escherichia coli and Salmonella typhi,''
Current Science 63 (12):744-747, 1992.
19. Nedoluha, P.C., and D. Westhoff. ``Microbiology of Striped Bass
Grown in Three Aquaculture Systems,'' Food Microbiology 14 (3),
1997.
20. De Roever, C.D. ``Microbiological Safety Evaluations and
Recommendations on Fresh Produce,'' Food Control 9 (6):321-347,
1998.
21. National Advisory Committee on Microbiological Criteria for
Food. 1999. ``Microbiological Safety Evaluations and Recommendations
on Sprouted Seed.'' Food and Drug Administration, last modified May
13, 2015. accessed October 19, 2015. http://www.fda.gov/food/guidanceregulation/guidancedocumentsregulatoryinformation/produceplantproducts/ucm078789.htm.
22. Food and Agriculture Organization and World Health Organization.
``CODEX Alimentarius Code of Hygienic Practice for Fresh Fruits and
Vegetables, CAC/RCP 53-2003.'' 2010.
23. Food and Agriculture Organization and World Health Organization.
``CODEX Alimentarius Code of Hygienic Practice for Fresh Fruits and
Vegetables CAC/RCP 53-2003, Annex II for Sprout Production.'' 2003.
24. Wells, J.M., and J.E. Butterfield. ``Salmonella Contamination
Associated with Bacterial Soft Rot of Fresh Fruits and Vegetables in
the Marketplace,'' Plant Disease 81 (8):867-872, 1997.
25. Wells, J.M., and J.E. Butterfield. ``Incidence of Salmonella on
Fresh Fruits and Vegetables Affected by Fungal Rots or Physical
Injury,'' Plant Disease 83 (8):722-726, 1999.
26. D'Lima, C., and K. Vierk. ``Memorandum to the File--Produce
Related Outbreaks and illnesses, December 2011.'' Food and Drug
Administration.
27. Gubernot, D. ``Memorandum to the File--Melon Outbreaks 1996-
2015, October 2015.'' Food and Drug Administration.
28. Merriweather, S., T.C. Cloyd, and D. Gubernot. ``Memorandum to
the File--2011-2014 Produce Related Outbreaks and Illnesses, May
2015.'' Food and Drug Administration.
29. Food and Drug Administration. ``Final Qualitative Assessment of
Risk to Public Health from On-Farm Contamination of Produce.'' 2015.
30. Vadlamudi, S., T.M. Taylor, C. Blankenburg, and A. Castillo.
``Effect of Chemical Sanitizers on Salmonella enterica Serovar Poona
on the Surface of Cantaloupe and Pathogen Contamination of Internal
Tissues as a Function of Cutting Procedure,'' Journal of Food
Protection 75 (10):1766-1773, 2012.
31. Joint FAO/WHO Food Standards Programme Codex Alimentarius
Commission. ``Pesticides Residues in Food, Codex Classification of
Foods and Animal Feeds.'' Rome, 1993.
32. Rutgers.edu. ``The IR-4 Project.'' last modified 2015. accessed
June 26, 2015. http://ir4.rutgers.edu/.
33. Environmental Protection Agency Office of Pesticide Programs.
``Pesticide Use Index: Index of Pesticide Use Sites--Corresponding
Major Use Pattern(s)--Crop Group.'' 2006.
34. ``Food Safety Good Agricultural Practices (GAP) for California
Citrus Growers.'' last modified 2010. accessed October 2015. http://calcitrusquality.org/wp-content/uploads/2009/05/Final-Food-Safety-GAP-document-_Oct-26_.pdf.
35. Herman, K.M., A.J. Hall, and L.H. Gould. ``Outbreaks Attributed
to Fresh Leafy Vegetables, United States, 1973-2012,'' Epidemiology
and Infection 143 (14):3011-3021, 2015.
36. Mercanoglu Taban, B., and A.K. Halkman. ``Do Leafy Green
Vegetables and Their Ready-To-Eat [RTE] Salads Carry a Risk of
Foodborne Pathogens?,'' Anaerobe 17 (6):286-287, 2011.
37. Food and Drug Administration. 2013. ``Food Code 2013.'' last
modified July 2, 2015. accessed October 14, 2015. http://www.fda.gov/Food/GuidanceRegulation/RetailFoodProtection/FoodCode/ucm374275.htm.
38. Food and Drug Administration. ``Raw Produce: Selecting and
Serving it Safely.'' last modified September 16, 2015. accessed June
2015. http://www.fda.gov/Food/ResourcesForYou/Consumers/ucm114299.htm.
39. Food and Drug Administration. 2006. ``Talking About Juice
Safety: What You Need to Know.'' last modified September 21, 2015.
accessed August 12, 2015. http://www.fda.gov/Food/ResourcesForYou/Consumers/ucm110526.htm.
40. Leafy Greens Marketing Agreement (LGMA) California Leafy Green
Products. ``Handler Marketing Agreement: The California Leafy Greens
Marketing Agreement.'' accessed June 23, 2015. http://www.farmfoundation.org/news/articlefiles/1819-363-scott%20horsfal.pdf.
41. Arizona Department of Agriculture. 2011. ``Arizona Leafy Green
Products Shipper Marketing Agreement.'' last modified October 1,
2011. accessed October 2015. https://agriculture.az.gov/sites/default/files/LEAFY_GREEN_MARKETING_AGREEMENT_2015_with_Tracked_Changes.pdf.
42. Food and Drug Administration. ``Memorandum to the File--
Qualitative Assessment of Risk to Public Health from On-Farm
Contamination of Produce--FDA Responses to Public and Peer Reviewer
Comments, October 2015.''
43. Food and Drug Administration. ``Quantitative Risk Assessment to
Support the Proposed Produce Rule.'' 2012. See Reference 42 to the
2013 proposed produce rule.
44. Ravaliya, K., M. Fatica, and E. Snellman. ``Memorandum to the
File--Review of Water Quality Standards in Development of Proposed
Microbial Standard in Sec. 112.44(c) of the Proposed Standards for
the Growing, Harvesting, Packing, and Holding of Produce for Human
Consumption, September 2014.'' Food and Drug Administration. See
Reference 13 to the 2014 proposed supplemental produce rule.
45. Snellman, E., F. Marianne, K. Ravaliya, and S. Assar.
``Memorandum to the File--Review of Microbial Decay Constants
Reported in Field Trials of Contaminated Produce, September 2014.''
Food and Drug Administration. See Reference 17 to the 2014 proposed
supplemental produce rule.
46. Beru, N. ``Memorandum to the File--Physical, Chemical and
Radiological Hazards Associated with Produce, May 2012.'' Food and
Drug Administration. See Reference 7 to the 2013 proposed produce
rule.
47. Smith, M.A., and S. Luccioli. ``Memorandum to the File--Addendum
to May 29, 2012 Memo on Chemical and Physical Hazards Associated
with Produce, October 2015.'' Food and Drug Administration.
48. Food and Drug Administration. ``Pesticide Monitoring Program
Fiscal Year 2012 Pesticide Report.'' 2012.
49. United Fresh Fruit and Vegetable Association. 2013. ``Field
Operations and Harvesting Harmonized Food Safety Standard.''
accessed June 2015. http://www.ams.usda.gov/sites/default/files/media/GAP-GHP-FieldHarvesting-Harmonized-Food-Safety.pdf.
50. United Fresh Fruit and Vegetable Association 2014. ``Post-
harvest Operations Harmonized Food Safety Standard.'' accessed June
2015. http://www.ams.usda.gov/sites/default/files/media/GAP-GHP-Post-Harvest-Harmonized-Food-Safety.pdf.
51. Joint Institute for Food Safety and Applied Nutrition. ``Good
Agricultural Practices (GAP) Manual.'' University of Maryland, last
modified 2015. accessed June 25, 2015. http://international.jifsan.umd.edu/catalogue/course/good_agricultural_practices/#GAPs_manual_english.
52. Environmental Protection Agency. 2007 ``About Pesticide
Registration.'' last modified July 28, 2015. accessed October 21,
2015. http://www2.epa.gov/pesticide-registration/about-pesticide-registration.
53. U.S. Department of Agriculture Agricultural Marketing Service.
``Pesticide Data Program, Annual Summary, Calendar Year 2013.''
2014.
54. U.S. Department of Health and Human Services, National
Institutes of Health,
[[Page 74541]]
and N.C. Institute. 2010 ``2008-2009 Annual Report--Reducing
Environmental Cancer Risk.'' accessed October 21, 2015. http://deainfo.nci.nih.gov/advisory/pcp/annualReports/pcp08-09rpt/PCP_Report_08-09_508.pdf.
55. Partnership for Food Safety Education. ``Fight Bac!: Safe
Handling of Fresh Fruits and Vegetables.'' http://www.fightbac.org/storage/documents/flyers/producebrochure.pdf, 2004.
56. Food and Drug Administration. 2009. ``Draft Guidance for
Industry: Guide to Minimize Microbial Food Safety Hazards of
Tomatoes.'' last modified April 30, 2015. accessed October 20, 2015.
http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/ucm173902.htm.
57. Food and Drug Administration. 2009. ``Draft Guidance for
Industry: Guide to Minimize Microbial Food Safety Hazards of Leafy
Greens.'' last modified April 30, 2015. accessed October 20, 2015.
http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/ucm174200.htm.
58. Food and Drug Administration. 2009. ``Draft Guidance for
Industry: Guide to Minimize Microbial Food Safety Hazards of
Melons.'' last modified April 30, 2015. accessed October 20, 2015.
http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/ucm174171.htm.
59. Produce Marketing Association and United Fresh Fruit and
Vegetable Association. ``Commodity Specific Food Safety Guidelines
for the Melon Supply Chain.'' http://www.fda.gov/downloads/Food/GuidanceRegulation/UCM168625.pdf, 2005.
60. North American Tomato Trade Work Group and California Tomato
Commission. 2008. ``Commodity Specific Food Safety Guidelines for
the Fresh Tomato Supply Chain.'' accessed June 2015. http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/ProducePlantProducts/ucm171695.htm.
61. Western Growers Association and Intertox Incorporated. 2010.
``Commodity Specific Food Safety Guidelines for the Production,
Harvest, Post-Harvest, and Valued-Added Unit Operations of Green
Onions.'' accessed June 2015. http://www.fda.gov/downloads/Food/FoodSafety/Product-SpecificInformation/FruitsVegetablesJuices/GuidanceComplianceRegulatoryInformation/UCM203114.pdf.
62. Association of Food and Drug Officials (AFDO). ``Association of
Food and Drug Officials Model Code for Produce Safety for State and
Local Regulatory Agencies.'' 2009.
63. Food and Drug Administration. 2009. ``Draft Guidance for
Industry: Ingredients Declared as Evaporated Cane Juice; Draft
Guidance.'' last modified April 30, 2015. accessed June 10, 2015.
http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/ucm181491.htm.
64. Andersen, R.A. ``Algae.'' last modified 2015. accessed June 24,
2015. http://www.britannica.com/science/algae.
65. Dictionary.com. ``Algae.'' last modified 2015. accessed June 24,
2015. http://dictionary.reference.com/browse/algae?s=t.
66. Lembi, C.A. ``Fact Sheet on Toxic Blue-Green Algae.'' Purdue
University, last modified August 2012. accessed June 24, 2015.
https://www.btny.purdue.edu/Pubs/APM/blue-green_factsheet.pdf.
67. University of California Museum of Paleontology. ``Introduction
to the Cyanobacteria.'' last modified 2006. accessed June 24, 2015.
http://www.ucmp.berkeley.edu/bacteria/cyanointro.html.
68. USA Dry Peas and Lentil Council. ``Processing Information and
Technical Manual.'' last modified 2010. accessed 2015. http://www.pea-lentil.com/core/files/pealentil/uploads/files/Chapter1.pdf.
69. Mazzotta, A.S. ``Heat Resistance of Listeria monocytogenes in
Vegetables: Evaluation of Blanching Processes,'' Journal of Food
Protection 64 (3):385-387, 2001.
70. Doyle, M.E., A.S. Mazzotta, T. Wang, D.W. Wiseman, and V.N.
Scott. ``Heat Resistance of Listeria monocytogenes,'' Journal of
Food Protection 64 (3):410-429, 2001.
71. DiPersio, P.A., P.A. Kendall, Y. Yoon, and J.N. Sofos.
``Influence of Blanching Treatments on Salmonella during Home-type
Dehydration and Storage of Potato Slices,'' Journal of Food
Protection 68 (12):2587-2593, 2005.
72. Bari, M.L., Y. Inatsu, S. Isobe, and S. Kawamoto. ``Hot Water
Treatments to Inactivate Escherichia coli O157:H7 and Salmonella in
Mung Bean Seeds,'' Journal of Food Protection 71 (4):830-834, 2008.
73. Tijerina, M., J. Johanson, J. Spungen, and S. Briguglio.
``Memorandum to the File--Produce Rarely Consumed Raw, October
2015.'' Food and Drug Administration.
74. Centers for Disease Control and Prevention. ``National Health
and Nutritional Examination Survey: What We Eat in America, NHANES
2003-2010, Dietary Interview--Individual Foods--First Day and
Dietary Interview--Individual Foods--Second Day.'' U.S. Department
of Health and Human Services, Centers for Disease Control and
Prevention. accessed June 25, 2015. http://www.cdc.gov/nchs/nhanes/nhanes_citation.htm.
75. Johanson, J. ``Memorandum to the File--Produce Rarely Consumed
Raw, June 2012.'' Food and Drug Administration. See Reference 79 to
the 2013 proposed produce rule.
76. Environmental Protection Agency Office of Pesticide Programs and
University of Maryland Joint Institute for Food Safety and Applied
Nutrition. 2015. ``Food Commodity Intake Database: What We Eat in
America.'' last modified 2015. accessed June 24, 2015. http://fcid.foodrisk.org/#.
77. Panerabread.com. ``Power Kale Caesar Salad with Chicken.'' last
modified 2015. accessed August 27, 2015. https://www.panerabread.com/en-us/menu-categories/salads.html#power-kale-caesar-salad-with-chicken.
78. Sweetgreen.com. ``Early Summer Menu: DC, MD and VA.'' last
modified 2015. accessed June 24, 2015. http://sweetgreen.com/menu/?region=dc-md-va.
79. Woodlandsveganbistro.com. ``Woodland's Vegan Bistro Menu.''
accessed June 24, 2015. http://www.woodlandsveganbistro.net/menu.htm.
80. Bobbyflay.com. 2014. ``Shredded Kale with Lime and Cotija.''
last modified 2014. accessed June 24, 2015. http://bobbyflay.com/recipes/recipes/59/shredded-kale-with-lime-and-cotija.
81. Wolfgangpuck.com. ``Kale Salad with Grilled Artichokes.'' last
modified 2015. accessed June 24, 2015. http://www.wolfgangpuck.com/recipes/salads/Kale-Salad-with-Grilled-Artichokes.
82. Clark, M. 2012. ``Making Sure Kale Gets a Raw Deal.''
NYTimes.com, last modified 2015. accessed June 24, 2015. http://www.nytimes.com/2012/11/07/dining/making-sure-kale-gets-a-raw-deal.html?_r=0.
83. CBSnews.com. ``Kale, the sexy green.'' last modified November
24, 2013. accessed June 24, 2015. http://www.cbsnews.com/news/kale-the-sexy-green/.
84. Herrig, B. ``Recipe: Kale Salad.'' CBSnews.com, last modified
November 23, 2013. accessed June 24, 2015. http://www.cbsnews.com/news/recipe-kale-salad/.
85. NPR.org. ``Raw Kale Salad.'' last modified May 22, 2012.
accessed June 24, 2015. http://www.npr.org/2012/05/22/153277267/raw-kale-salad.
86. Fahr, Y. 2012. ``Raw Kale and Spinach Salad.'' Fox News. http://www.foxnews.com/recipe/raw-kale-and-spinach-salad.
87. Bjork, K. 2015. ``Kale Smoothie for Breakfast.''
Huffingtonpost.com, last modified 2015. accessed June 24, 2015.
http://www.huffingtonpost.com/katrin-bjork/kale-smoothie-for-breakfa_b_6893550.html?utm_hp_ref=kale.
88. International Commission on Microbiological Specifications for
Foods. ``Fermented Beverages.'' Microorganisms in Foods 6: Microbial
Ecology of Food Commodities, edited by T.A. Roberts, J.-L. Cordier,
L. Gram, R.B. Tompkin, J.I. Pitt, L.G.M. Gorris and K.M.J. Swanson,
pp 716-724. New York: Kluwer Academic/Plenum Publishers, 2005.
89. Food and Drug Administration. 2008. ``Guidance for Industry:
Guide to Minimize Microbial Food Safety Hazards of Fresh-cut Fruits
and Vegetables.'' last modified December 16, 2014. accessed October
26, 2015. http://www.fda.gov/food/guidanceregulation/ucm064458.htm.
[[Page 74542]]
90. Million, D. ``Dry Hopping: Techniques.'' BYO.com, last modified
September 2003. accessed June 24, 2015. https://byo.com/hops/item/569-dry-hopping-techniques.
91. University of California Davis. ``National Grape Registry
(NGR).'' last modified 2015. accessed June 24, 2015. http://ngr.ucdavis.edu/.
92. Parrott, C., and C.A. Morris. ``Big Help for Small Producers.''
U.S. Department of Agriculture, last modified September 22, 2014.
accessed June 24, 2015. http://blogs.usda.gov/2014/09/22/big-help-for-small-producers/#sthash.jEZMCTlm.dpuf%29.
93. Food and Drug Administration. 2012. ``Guidance for Industry:
Testing Salmonella Species in Human Foods and Direct-Human-Contact
Animal Food.'' last modified September 29, 2015. accessed October
16, 2015. http://www.fda.gov/food/guidanceregulation/guidancedocumentsregulatoryinformation/ucm295271.htm.
94. Food and Drug Administration. 2009. ``Guidance for Industry:
Measures to Address the Risk for Contamination by Salmonella Species
in Food Containing a Peanut-Derived Product as an Ingredient.'' last
modified April 30, 2015. accessed June 23, 2015. http://www.fda.gov/food/guidanceregulation/guidancedocumentsregulatoryinformation/ucm115386.htm.
95. National Organic Standards Board (NOSB). 2006. ``Crops Committee
Recommendation for Guidance: Use of Compost, Vermicompost, Processed
Manure and Compost Teas.'' accessed June 23, 2015. http://www.ams.usda.gov/sites/default/files/media/NOP%20Final%20Rec%20Guidance%20use%20of%20Compost.pdf.
96. Food and Drug Administration. 1982. ``CPG Sec. 555.750 Seeds for
Sprouting Prior to Food Use, i.e., Dried Mung Beans, Alfalfa Seeds,
etc.'' last modified March 20, 2015. accessed June 23, 2015. http://www.fda.gov/ICECI/ComplianceManuals/CompliancePolicyGuidanceManual/ucm074562.htm.
97. Food and Drug Administration. 1999. ``Guidance for Industry:
Sampling and Microbial Testing of Spent Irrigation Water During
Sprout Production.'' last modified April 14, 2015. accessed June 24,
2015. http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/ProducePlantProducts/ucm120246.htm.
98. Bureau of Economic Analysis. Gross Domestic Product. U.S.
Department of Commerce. Accessed October 29, 2015. http://www.bea.gov.
99. Bowers, J. ``Memorandum to the File--Minimum Sample Size for
Rolling Calculation of Microbial Water Quality Profile of Surface
Water Sources to be Used for Agricultural Water, September 2015.''
Food and Drug Administration.
100. Environmental Protection Agency. 2012. ``Recreational Water
Quality Criteria.'' accessed June 26, 2015. http://water.epa.gov/scitech/swguidance/standards/criteria/health/recreation/upload/RWQC2012.pdf.
101. Macdonald, D.J., E.C. McKillop, S. Trotter, and A. Gray, Jr.
``Improving Hand-Washing Performance--a Crossover Study of Hand-
Washing in the Orthopaedic Department,'' Annals of The Royal College
of Surgeons of England 88 (3):289-291, 2006.
102. Helder, O.K., J. Brug, C.W. Looman, J.B. van Goudoever, and
R.F. Kornelisse. ``The Impact of an Education Program on Hand
Hygiene Compliance and Nosocomial Infection Incidence in an Urban
Neonatal Intensive Care Unit: An Intervention Study with Before and
After Comparison,'' International Journal of Nursing Studies 47
(10):1245-1252, 2010.
103. Todd, E.C.D., B.S. Michaels, D. Smith, J.D. Greig, and C.A.
Bartleson. ``Outbreaks Where Food Workers Have Been Implicated in
the Spread of Foodborne Disease. Part 9. Washing and Drying of Hands
to Reduce Microbial Contamination,'' Journal of Food Protection 73
(10):1937-1955, 2010.
104. Bellamy, K., K.L. Laban, K.E. Barrett, and DCS. Talbot.
``Detection of Viruses and Body Fluids Which May Contain Viruses in
the Domestic Environment,'' Epidemiology and Infection 121 (3):673-
680, 1998.
105. Arrow, B.B. ``Salmonella Enteritidis Isolated from Sputum:
Report of Case,'' Journal of American Optometric Association 80
(9):609-612, 1981.
106. Smith, D.L., D.E. Stableforth, and E.G. Smith. ``Salmonella
newport in the Sputum of a Patient with Cystic Fibrosis,''
Respiratory Medicine 87:625-627, 1993.
107. Committee on Indicators for Waterborne Pathogens. 2004.
``Indicators for Waterborne Pathogens.'' The National Academies
Press. accessed June 25, 2015. http://www.nap.edu/openbook.php?record_id=11010.
108. Carrillo, M., Estrada, E., Hazen, T. C. ``Survival and
Enumeration of the Fecal Indicators Bifidobacterium adolescentis and
E. coli in a Tropical Rain Forest Watershed,'' Applied and
Environmental Microbiology 50 (2):468-476, 1985.
109. Gauthier, F., and F. Archibald. ``The Ecology of ``Fecal
Indicator'' Bacteria Commonly Found in Pulp and Paper Mill Water
Systems,'' Water Research 35 (9):2207-2218, 2001.
110. McElhany, K.G., and S.D. Pillai. ``Prevalence and Fate of Gut-
Associated Human Pathogens in the Environment.'' The Fecal Bacteria,
edited by M.J. Sadowsky, Whitman, R. L., pp 217-240. Washington, DC:
American Society for Microbiology, 2011.
111. Cooley, M., D. Carychao, L. Crawford-Miksza, M.T. Jay, C.
Myers, C. Rose, C. Keys, J. Farrar, and R.E. Mandrell. ``Incidence
and Tracking of Escherichia coli O157:H7 in a Major Produce
Production Region in California,'' PLoS One 2 (11):e1159, 2007.
112. Leclerc, H., D.A.A. Mossel, S.C. Edberg, and C.B. Struijk.
``Advances in the Bacteriology of the Coliform Group: Their
Suitability as Markers of Microbial Water Safety,'' Annual Review of
Microbiology 55:201-234, 2001.
113. Tallon, P., B. Magajna, C. Lofranco, and K. Leung. ``Microbial
Indicators of Faecal Contamination in Water: A Current
Perspective,'' Water, Air, and Soil Pollution 166 (1):139-166, 2005.
114. McLellan, S.L., A.D. Daniels, and A.K. Salmore. ``Clonal
Populations of Thermotolerant Enterobacteriaceae in Recreational
Water and Their Potential Interference with Fecal Escherichia coli
Counts,'' Applied and Environmental Microbiology 67 (10):4934-4938,
2001.
115. Diez-Gonzalez, F. ``Fecal Bacteria and Foods.'' The Fecal
Bacteria, edited by M.J. Sadowsky and R.L. Whitman, pp 275-293.
Washington, DC: American Society for Microbiology, 2011.
116. Environmental Protection Agency Office of Water Regulations and
Standards Criteria and Standards Divisions. ``Ambient Water Quality
Criteria for Bacteria--1986.'' Washington, DC. http://water.epa.gov/scitech/swguidance/standards/upload/2001_10_12_criteria_ambientwqc_bacteria1986.pdf, 1986.
117. Warrington, P.D., and T.R. Johnson. ``Water Quality Criteria
for Microbiological Indicators.'' Government of British Columbia,
last modified March 8, 2001. accessed October 14, 2015. http://www.env.gov.bc.ca/wat/wq/BCguidelines/microbiology/microbiology.html#tab1.
118. Gerba, C.P. ``The Role of Water and Water Testing in Produce
Safety '' Microbial Safety of Fresh Produce, edited by X. Fan, B.A.
Niemira, C.J. Doona, F.E. Feeherry and R.B. Gravani, pp 129-142.
Ames, IA: Wiley-Blackwell, 2009
119. Howell, J.M., M.S. Coyne, and P.L. Cornelius. ``Fecal Bacteria
in Agricultural Waters of the Bluegrass Region of Kentucky,''
Journal of Environmental Quality 24:411-419, 1995.
120. Garzio-Hadzick, A., D.R. Shelton, R.L. Hill, Y.A. Pachepsky,
A.K. Guber, and R. Rowland. ``Survival of Manure-borne E. coli in
Streambed Sediment: Effects of Temperature and Sediment
Properties,'' Water Research 44 (9):2753-2762, 2010.
121. Whitman, R.L., M.B. Nevers, K. Przybyla-Kelly, and M.N.
Byappanahalli. ``Physical and Biological Factors Influencing
Environmental Sources of Fecal Indicator Bacteria in Surface
Water.'' The Fecal Bacteria, edited by M.J. Sadowsky and R.L.
Whitman, pp 111-134. Washington, DC: American Society for
Microbiology, 2011.
122. Pachepsky, Y.A., and D.R. Shelton. ``Escherichia coli and Fecal
Coliforms in Freshwater and Estuarine Sediments,'' Critical Reviews
in Environmental Science and Technology 41 (12):1067-1110, 2011.
123. World Health Organization and United Nations Environmental
Programs. ``WHO Guidelines for the Safe Use of Wastewater, Excreta,
and Greywater, Vol II.'' In Wastewater use in agriculture. Geneva,
Switzerland, 2006.
124. Reynolds, K.A., K.D. Mena, and C.P. Gerba. ``Risk of Waterborne
Illness Via Drinking Water in the United States,''
[[Page 74543]]
Reviews of Environmental Contamination and Toxicology 192:117-158,
2008.
125. Westrell, T., O. Bergstedt, T.A. Stenstrom, and N.J. Ashbolt.
``A Theoretical Approach to Assess Microbial Risks Due to Failures
in Drinking Water Systems,'' International Journal of Environmental
Health Research 13 (2):181-197, 2003.
126. Food and Drug Administration. ``Final Environmental Impact
Statement for the Proposed Rule Standards for Growing, Harvesting,
Packing, and Holding of Produce for Human Consumption, October
2015.''
127. Environmental Protection Agency. ``Pesticide Registration
Manual: Chapter 1--Overview of Requirements for Pesticide
Registration and Registrant Obligations.'' last modified October 15,
2015. accessed October 16, 2015. http://www2.epa.gov/pesticide-registration/pesticide-registration-manual-chapter-1-overview-requirements-pesticide#laws.
128. Environmental Protection Agency. Availability of Pesticides for
Use in Produce Wash or Process Water to Control E. coli, January
2014.'' Washington, DC.
129. Environmental Protection Agency. ``Pesticides: Regulating
Pesticides.'' last modified October 14, 2015. accessed October 21,
2015. http://www2.epa.gov/pesticides.
130. Environmental Protection Agency. ``Pesticide Registration
Manual: Chapter 13--Devices.'' last modified June 25, 2015. accessed
June 26, 2015. http://www2.epa.gov/pesticide-registration/pesticide-registration-manual-chapter-13-devices.
131. National Pesticide Information Center. ``State Pesticide
Regulatory Agencies.'' accessed June 26, 2015. http://npic.orst.edu/reg/state_agencies.html.
132. Environmental Protection Agency. ``Tribal Pesticide Programs.''
last modified October 14, 2015. accessed October 26, 2015. http://www2.epa.gov/pesticide-advisory-committees-and-regulatory-partners/tribal-pesticide-programs.
133. Environmental Protection Agency. ``Product Labeling--Pesticide
Product Label System.'' accessed October 16, 2015. http://iaspub.epa.gov/apex/pesticides/f?p=PPLS:1.
134. Food and Drug Administration. ``Endangered Species Action
Section 7 No Effects Determination, December 2014.''
135. Food and Drug Administration. ``Supplement to Endangered
Species Act Section 7 No Effects Determination, October 2015.''
136. Suslow, T.V. 1997 ``Postharvest Chlorination: Basic Properties
and Key Points for Effective Disinfection.'' University of
California, Division of Agriculture and Natural Resources. accessed
June 26, 2015. http://anrcatalog.ucdavis.edu/pdf/8003.pdf.
137. Suslow, T.V. 2001 ``Water Disinfection: A Practical Approach to
Calculating Dose Values for Preharvest and Postharvest
Applications.'' The University of California, Division of
Agriculture and Natural Resources. accessed June 26, 2015. http://anrcatalog.ucdavis.edu/pdf/7256.pdf.
138. Ritenour, M.A., S.A. Sargent, and J.A. Bartz. 2002. ``Chlorine
Use in Produce Packing Lines.'' Institute of Food Safety and
Agricultural Sciences, University of Florida. accessed June 26,
2015. http://edis.ifas.ufl.edu/pdffiles/CH/CH16000.pdf.
139. University of Florida IFAS Extension. ``Citrus Postharvest and
Handling.'' last modified 2015. accessed June 26, 2015. http://edis.ifas.ufl.edu/topic_citrus_post_harvest.
140. Food and Drug Administration. ``Determining Regulatory
Authority for Antimicrobial Substances.'' last modified July 28,
2015. accessed June 26, 2015. http://www.fda.gov/Food/IngredientsPackagingLabeling/PackagingFCS/RegulatoryAuthorityAntimicrobialSubstances/default.htm.
141. Shannon, M.A., P.W. Bohn, E. Menachem, J.G. Georgiadis, B.J.
Marinas, and A.M. Mayes. ``Science and Technology for Water
Purification in the Coming Decades,'' Nature 452 (20):301-310, 2008.
142. Food and Drug Administration. ``Final Regulatory Impact
Analysis, Final Regulatory Flexibility Analysis, and Unfunded
Mandates Reform Act Analysis for the Standards for the Growing,
Harvesting, Packing and Holding of Produce for Human Consumption.''
October 2015.
143. Natural Resource Management Ministerial Council and Environment
Protection and Heritage Council and Australian Health Ministers
Conference. ``Australian Guidelines for Water Recycling: Managing
Health and Environmental Risk (Phase 1).'' 2006.
144. Assar, S. ``Memorandum to the File--Addendum to September 16,
2014 Memo on Review of Microbial Decay Constants Reported in Field
Trials of Contaminated Produce, October 2015.'' Food and Drug
Administration.
145. Petterson, S.R., N.J. Ashbolt, and A. Sharma. ``Microbial Risks
from Wastewater Irrigation of Salad Crops: A Screening-Level Risk
Assessment,'' Water Environmental Research: A Research Publication
of the Water Environment Federation 72 (6):667-672, 2001.
146. Petterson, S.R., N.J. Ashbolt, and A. Sharma. ``Of: Microbial
Risks from Wastewater Irrigation of Salad Crops: A Screening-Level
Risk Assessment,'' Water Environmental Research: A Research
Publication of the Water Environment Federation 74:411, 2002.
147. Wood, J.D., G.S. Bezanson, R.J. Gordon, and R. Jamieson.
``Population Dynamics of Escherichia coli Inoculated by Irrigation
into the Phyllosphere of Spinach Grown under Commercial Production
Conditions,'' International Journal of Food Microbiology 143
(3):198-204, 2010.
148. Fonseca, J.M., S.D. Fallon, C.A. Sanchez, and K.D. Nolte.
``Escherichia coli Survival in Lettuce Fields Following Its
Introduction Through Different Irrigation Systems,'' Journal of
Applied Microbiology 110 (4):893-902, 2011.
149. Moyne, A.L., M.R. Sudarshana, T. Blessington, S.T. Koike, M.D.
Cahn, and L.J. Harris. ``Fate of Escherichia coli O157:H7 in Field-
Inoculated Lettuce,'' Food Microbiology 28 (8):1417-1425, 2011.
150. Food and Drug Administration. ``Record of Decision. Final
Environmental Impact Statement- Standards for the Growing,
Harvesting, Packing, and Holding of Produce for Human Consumption,
October 2015.''
151. Close, M., R. Dann, A. Ball, R. Pirie, M. Savill, and Z. Smith.
``Microbial Groundwater Quality and Its Health Implications for a
Border-Strip Irrigated Dairy Farm Catchment, South Island, New
Zealand,'' Journal of Water and Health 6 (1):83-98, 2008.
152. Leifert, C., K. Ball, N. Volakakis, and J.M. Cooper. ``Control
of Enteric Pathogens in Ready-to-Eat Vegetable Crops in Organic and
`Low Input' Production Systems: a HACCP-Based Approach,'' Journal of
Applied Microbiology 105 (4):931-950, 2008.
153. Gelting, R.J., M.A. Baloch, M.A. Zarate-Bermudez, and C.
Selman. ``Irrigation Water Issues Potentially Related to the 2006
Multistate E. coli O157:H7 Outbreak Associated with Spinach,''
Agricultural Water Management 98 (9):1395-1402, 2011.
154. Gelting, R.J., and M.A. Baloch. ``The Food-Water Nexus:
Irrigation Water Quality, Risks to Food Safety, and the Need for a
Systems-Based Preventive Approach,'' Journal of Environmental Health
75 (3):40-41, 2012.
155. Food and Drug Administration. 2015. ``Chapter 4--Sampling in
Investigations Operations Manual 2015.'' accessed October 16, 2015.
http://www.fda.gov/downloads/ICECI/Inspections/IOM/UCM123507.pdf.
156. Government of Australia Department of Health. 2010. ``Standard
Microbiological Water Sampling Technique.'' last modified October
25, 2010. accessed June 2015. http://www.public.health.wa.gov.au/cproot/1310/2/Environmental%20waters%20micro%20sampling%20technique.pdf.
157. Hunt, M.E. ``9060 Samples.'' Standard Methods for the
Examination of Water and Wastewater, edited by E.W. Rice, R.B.
Baird, A.D. Eaton and L.S. Clesceri, pp 9/33-9/36. Washington, DC:
American Public Health Association, American Water Works
Association, and Water environment Federation, 2012.
158. Buchanan, R.L., S.G. Edelson, R.L. Miller, and G.M. Sapers.
``Contamination of Intact Apples after Immersion in an Aqueous
Environment Containing Escherichia coli O157: H7,'' Journal of Food
Protection 62 (5):444-450, 1999.
159. Merker, R., S. Edelson-Mammel, V. Davis, and R.L. Buchanan.
``Preliminary Experiments on the Effect of
[[Page 74544]]
Temperature Differences on Dye Uptake by Oranges and Grapefruit.''
Food and Drug Administration, last modified July 16, 2014. accessed
October 14, 2015. http://www.fda.gov/food/guidanceregulation/haccp/ucm082931.htm.
160. Bartz, J.A., and R.K. Showalter. ``Infiltration of Tomatoes by
Aqueous Bacterial Suspensions,'' Phytopathology 71 (5):515-518,
1981.
161. Bartz, J.A. ``Potential for Postharvest Disease in Tomato Fruit
Infiltrated with Chlorinated Water,'' Plant Disease 72 (1):9-13,
1988.
162. Penteado, A.L., B.S. Eblen, and A.J. Miller. ``Evidence of
Salmonella Internalization into Fresh Mangos during Simulated
Postharvest Insect Disinfection Procedures,'' Journal of Food
Protection 67 (1):181-184, 2004.
163. Sivapalasingam, S., E. Barrett, A. Kimura, S. Van Duyne, W. De
Witt, M. Ying, A. Frisch, Q. Phan, E. Gould, P. Shillam, V. Reddy,
T. Cooper, M. Hoekstra, C. Higgins, J.P. Sanders, R.V. Tauxe, and L.
Slutsker. ``A Multistate Outbreak of Salmonella enterica Serotype
Newport Infection Linked to Mango Consumption: Impact of Water-Dip
Disinfestation Technology,'' Clinical Infectious Diseases 37
(12):1585-1590, 2003.
164. Xia, X., Y. Luo, Y. Yang, B. Vinyard, K. Schneider, and J.
Meng. ``Effects of Tomato Variety, Temperature Differential, and
Post-Stem Removal Time on Internalization of Salmonella enterica
Serovar Thompson in Tomatoes,'' Journal of Food Protection 75
(2):297-303, 2012.
165. Bartlett, K.H., T.J. Trust, and H. Lior. ``Small Pet Aquarium
Frogs as a Source of Salmonella,'' Applied and Environmental
Microbiology 33 (5):1026-1029, 1977.
166. Pfleger, S., G. Benyr, R. Sommer, and A. Hassl. ``Pattern of
Salmonella Excretion in Amphibians and Reptiles in a Vivarium,''
International Journal of Hygiene and Environmental Health 206
(1):53-59, 2003.
167. Novotny, L., L. Dvorska, A. Lorencova, V. Beran, and I. Pavlik.
``Fish: a Potential Source of Bacterial Pathogens for Human
Beings,'' Veterinary Medicine 49 (9):343-358, 2004.
168. Brinton, J.W.F., P. Storms, and T.C. Blewett. ``Occurrence and
Levels of Fecal Indicators and Pathogenic Bacteria in Market-Ready
Recycled Organic Matter Composts,'' Journal of Food protection 72
(2):332-339, 2009.
169. Erickson, M., F. Critzer, and M. Doyle. ``Issue Brief on
Composting of Animal Manures: Composting Criteria for Animal
Manure.'' PEW Produce Safety Project, 2010.
170. Par[eacute], T., H. Dinel, M. Schnitzer, and S. Dumontet.
``Transformation of Carbon and Nitrogen During Composting of Animal
Manure and Shredded Paper,'' Biology and Fertility of Soils 26
(3):173-178, 1998.
171. Bernal, M.P., J.A. Alburquerque, and R. Moral. ``Composting of
Animal Manures and Chemical Criteria for Compost Maturity
Assessment. A review,'' Bioresource Technology 100 (22):5444-5453,
2009.
172. US Composting Council. 2008. ``USCC Fact Sheet: Compost and its
Benefits.'' accessed June 19, 2015. http://compostingcouncil.org/wp/wp-content/uploads/2010/09/Compost-and-Its-Benefits.pdf.
173. Mehta, C.M., U. Palni, I.H. Franke-Whittle, and A.K. Sharma.
``Compost: Its Role, Mechanism and Impact on Reducing Soil-Borne
Plant Diseases,'' Waste Management 34 (3):607-622, 2014.
174. Ingram, D.T., and P.D. Millner. ``Factors Affecting Compost Tea
as a Potential Source of Escherichia coli and Salmonella on Fresh
Produce,'' Journal of Food Protection 70 (4):828-834, 2007.
174a. Environmental Protection Agency. ``Pesticide Registration
Manual: Chapter 11--Tolerance Petitions.'' last modified October 6,
2015. accessed October 28, 2015. http://www2.epa.gov/pesticide-registration/pesticide-registration-manual-chapter-11-tolerance-petitions.
175. Duffy, B., C. Sarreal, S. Ravva, and L. Stanker. ``Effect of
Molasses on Regrowth of E. coli O157:H7 and Salmonella in Compost
Teas,'' Compost Science and Utilization 12 (1):93-96, 2004.
176. Kannangara, T., T. Forge, and B. Dang. ``Effects of Aeration,
Molasses, Kelp, Compost type, and Carrot Juice on the Growth of
Escherichia coli in Compost teas,'' Compost Science and Utilization
14 (1):40-47, 2006.
177. National Academy of Sciences, Committee on Toxicants and
Pathogens in Biosolids Applied to Land, Board on Environmental
Studies and Toxicology, Division on Earth and Life Studies, and
National Research Council. 2002. ``Biosolids Applied to Land:
Advancing Standards and Practices.'' accessed June 22, 2015. http://www.nap.edu/catalog/10426/biosolids-applied-to-land-advancing-standards-and-practices.
178. Environmental Protection Agency. ``Water Home.'' last modified
April 9, 2015. accessed October 26, 2015. http://water.epa.gov/.
179. Environmental Protection Agency Office of Water. ``Biosolids
Technology Fact Sheet: Use of Composting for Biosolids Management.''
Washington, DC, 2002.
180. Environmental Protection Agency. ``Environmental Regulations
and Technology: Control of Vector Attraction in Sewage Sludge.''
Cincinnati, OH, 2003.
181. Beuchat, L.R. ``Pathogenic Microorganisms Associated with Fresh
Produce,'' Journal of Food Protection 59 (2):204-216, 1996.
182. Beuchat, L.R. ``Survival of Enterohemorrhagic Escherichia coli
O157: H7 in Bovine Feces Applied to Lettuce and the Effectiveness of
Chlorinated Water as a Disinfectant,'' Journal of Food Protection 62
(8):845-849, 1999.
183. Lynch, M.F., R.V. Tauxe, and C.W. Hedberg. ``The Growing Burden
of Foodborne Outbreaks Due to Contaminated Fresh Produce: Risks and
Opportunities,'' Epidemiology and Infection 137 (3):307-315, 2009.
184. Seo, K.H., and J.F. Frank. ``Attachment of Escherichia coli
O157:H7 to Lettuce Leaf Surface and Bacterial Viability in Response
to Chlorine Treatment as Demonstrated by Using Confocal Scanning
Laser Microscopy,'' Journal of Food Protection 62 (1):3-9, 1999.
185. Brackett, R.E. ``Microbiological Consequences of Minimally
Processed Fruits and Vegetables,'' Journal of Food Quality 10:195-
206, 1987.
186. Nielsen, E.M., M.N. Skov, J.J. Madsen, J. Lodal, J.B.
Jespersen, and D.L. Baggesen. ``Verocytotoxin-Producing Escherichia
coli in Wild Birds and Rodents in Close Proximity to Farms,''
Applied and Environmental Microbiology 70 (11):6944-6947, 2004.
187. Pell, A.N. ``Manure and Microbes: Public and Animal Health
Problem?,'' Journal of Dairy Science 80 (10):2673-2681, 1997.
188. Renter, D.G., and J.M. Sargeant. ``Enterohemorrhagic
Escherichia coli O157: Epidemiology and Ecology in Bovine Production
Environments,'' Animal Health Research Reviews 3 (2):83-94, 2002.
189. Resource Conservation District of Monterey County. ``Handbook
of Agricultural Conservation Practices: Photos and Descriptions with
Food Safety Considerations, 2nd Edition.'' 2009.
190. Whipp, S.C., M.A. Rasmussen, and W.C.J. Cray. ``Animals as a
Source of Escherichia coli Pathogenic for Human Beings,'' Journal of
the American Medical Association 204 (8):1168-1175, 1994.
191. Atwill, E.R., M. Partyka, R.F. Bond, X. Li, C. Xiao, and L.E.
Kiger. ``An Introduction to Waterborne Pathogens in Agricultural
Watersheds, Second Edition.'' National Resources Conservation
Center, USDA, 2011.
192. Riordan, D.C.R., G.M. Sapers, T.R. Hankinson, M. Magee, A.M.
Mattrazzo, and B.A. Annous. ``A Study of U.S. Orchards to Identify
Potential Sources of Escherichia coli O157:H7,'' Journal of Food
Protection 64 (9):1320-1327, 2001.
193. Duffy, S., and D.W. Schaffner. ``Monte Carlo Simulation of the
Risk of Contamination of Apples with Escherichia coli O157:H7,''
International Journal of Food Microbiology 78 (3):245-255, 2002.
194. Food and Drug Administration. 2013. ``FDA Investigation
Summary--Multistate Outbreak of Salmonella Braenderup Infections
Associated with Mangoes.'' last modified July 21, 2014. accessed
August 19, 2015. http://www.fda.gov/Food/RecallsOutbreaksEmergencies/Outbreaks/ucm317337.htm.
195. Centers for Disease Control and Prevention. ``Multistate
Outbreak of Human Salmonella Agona Infections Linked to Whole, Fresh
Imported Papayas (Final Update).'' last modified
[[Page 74545]]
August 29, 2011. accessed October 16, 2015. http://www.cdc.gov/salmonella/2011/papayas-8-29-2011.html.
196. Food and Drug Administration. 2012. ``Information on the
Recalled Jensen Farms Whole Cantaloupes.'' last modified July 21,
2014. accessed October 16, 2015. http://www.fda.gov/Food/RecallsOutbreaksEmergencies/Outbreaks/ucm272372.htm.
197. Sugiyama, H., and K.H. Yang. ``Growth Potential of Clostridium
botulinum in Fresh Mushrooms Packaged in Semipermeable Plastic
Film,'' Applied Microbiology 30 (6):964-969, 1975.
198. Austin, J.W., K.L. Dodds, B. Blanchfield, and J.M. Farber.
``Growth and Toxin Production by Clostridium Botulinum on Inoculated
Fresh-Cut Packaged Vegetables,'' Journal of Food Protection 61
(3):324-328, 1998.
199. Farber, J.N., L.J. Harris, M.E. Parish, L.R. Beuchat, T.V.
Suslow, J.R. Gorney, E.H. Garrett, and F.F. Busta. ``Microbiological
Safety of Controlled and Modified Atmosphere Packaging of Fresh and
Fresh-Cut Produce,'' Comprehensive Reviews in Food Science and Food
Safety 2 (Supplement s1):143-160, 2003.
200. Health Products and Food Branch Health Canada. ``Health Canada
Guidance Concerning the Packaging of Fresh Mushrooms.'' last
modified July 8, 2013. accessed November 29, 2011. http://www.hc-sc.gc.ca/fn-an/legislation/guide-ld/mushrooms-champignons-050817-eng.php.
201. Sugiyama, H., and K.S. Rutledge. ``Failure of Clostridium
botulinum to Grow in Fresh Mushrooms Packaged in Plastic Film
Overwraps with Holes,'' Journal of Food Protection 41 (5):348-350,
1978.
202. Nguyen-the, C., and F. Carlin. ``Fresh and Processed
Vegetables.'' The microbiological safety and quality of food, edited
by B.M. Lund, T.C. Baird-Parker and G.W. Gould, pp 620-684.
Gaithersburg, MD: Aspen Publishers, Inc., 2000.
203. Duffy, E.A., L.M. Lucia, J.M. Kells, A. Castillo, and G.R.
Acuff. ``Concentrations of Escherichia coli and Genetic Diversity
and Antibiotic Resistance Profiling of Salmonella Isolated from
Irrigation Water, Packing Shed Equipment, and Fresh Produce in
Texas,'' Journal of Food Protection 68 (1):70-79, 2005.
204. Taormina, P.J., L.R. Beuchat, M.C. Erickson, L. Ma, G. Zhang,
and M.P. Doyle. ``Transfer of Escherichia coli O157:H7 to Iceberg
Lettuce via Simulated Field Coring,'' Journal of Food Protection 72
(3):465-472, 2009.
205. Moore, C.M., B.W. Sheldon, and L. Jaykus. ``Transfer of
Salmonella and Campylobacter from Stainless Steel to Romaine
Lettuce,'' Journal of Food Protection 66 (12):2231-2236, 2003.
206. Food and Drug Administration. 1999. ``Guidance for Industry:
Reducing Microbial Food Safety Hazards For Sprouted Seeds.'' last
modified 2011. accessed December 1, 2011. http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/ProducePlantProducts/ucm120244.htm.
207. Food and Drug Administration. 2009. ``Letter from FDA to Seed
Suppliers, Distributors, and Sprouters.'' last modified May 15,
2009. accessed October 19, 2015. www.fda.gov/NewsEvents/PublicHealthFocus/ucm151758.htm.
208. Shakir, F.K. ``Memorandum to the File--Summary of FY14-15
Sprout Assignment, October 2015.'' Food and Drug Administration.
209. Brooks, J.T., S.Y. Rowe, P. Shillam, D.M. Heltzel, S.B. Hunter,
L. Slutsker, M. Hoekstra, and S.P. Luby. ``Salmonella Typhimurium
Infections Transmitted by Chlorine-pretreated Clover Sprout Seeds,''
American Journal of Epidemiology 154 (11):1020-1028, 2001.
210. Montville, R., and D. Schaffner. ``Monte Carlo Simulation of
Pathogen Behavior During the Sprout Production Process,'' Applied
and Environmental Microbiology 71 (2):746-753, 2005.
211. Food Safety Authority of Ireland. ``Guidelines on Safe
Production of Ready-to-Eat Sprouted Seeds (Sprouts).'' 2011.
212. Canadian Food Inspection Agency. 2007. ``Code of Practice for
the Hygienic Production of Sprouted Seeds.'' last modified October
20, 2014. accessed October 13, 2015. http://www.inspection.gc.ca/food/fresh-fruits-and-vegetables/food-safety/sprouted-seeds/eng/1413825271044/1413825272091.
213. European Commission. ``Commission Regulation (EC) No 2073/2005
of 15 November 2005 on Microbiological Criteria for Foodstuffs.''
available at: http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2005:338:0001:0026:EN:PDF, 2005.
214. Tompkin, R.B., V.N. Scott, D.T. Bernard, W.H. Sveum, and K.S.
Gombas. ``Guidelines to Prevent Post-Processing Contamination from
Listeria monocytogenes,'' Dairy, Food and Environmental Sanitation
19 (8):551-562, 1999.
215. Food and Drug Administration. 2009. ``Amalgamated Produce, Inc.
Recalls Sprouts in the North Eastern United States Because of
Possible Health Risk.'' last modified July 10, 2013. accessed
October 19, 2015. http://www.fda.gov/Safety/Recalls/ArchiveRecalls/2009/ucm135947.htm.
216. Food and Drug Administration. ``Kkot Saem Sprouts, Inc. Recalls
Soybean Sprouts and Mungbean Sprouts Because of Possible Health
Risk.'' last modified December 19, 2014. accessed October 19, 2015.
http://www.fda.gov/Safety/Recalls/ucm427666.htm.
217. Food and Drug Administration. ``Good Seed Inc. Recalls Soybean
Sprouts & Mung Bean Sprouts Due To A Possible Health Risk.'' last
modified August 11, 2015. accessed October 19, 2015. http://www.fda.gov/Safety/Recalls/ucm458037.htm.
218. Food and Drug Administration. ``Recalls: Listeria monocytogenes
in Sprouts.'' FDA Recall Enterprise System. accessed October 23,
2015.
219. Institute for Food Safety and Health. ``Auditing and Inspection
Checklist for Sprouting Facilities.'' last modified 2011. accessed
October 19, 2015. http://www.iit.edu/ifsh/sprout_safety/resources/pdf/ifsh2011_sproutsafetyaudit.pdf.
220. Food Standards Australia New Zealand. ``Proposal P1004, Primary
Production and Processing Standard for Seed Sprouts, Approval
Report.'' 2011.
221. Smith, M.A. ``Evolution of FDA's Policy: Sprouts versus
Microgreens.'' IAFP Annual Meeting, Indianapolis, IN, August 5,
2014, 2014
222. Xiao, Z., X. Nou, Y. Luo, and Q. Wang. ``Comparison of the
Growth of Escherichia coli O157: H7 and O104: H4 During Sprouting
and Microgreen Production from Contaminated Radish Seeds,'' Food
Microbiology 44:60-63, 2014.
223. Fett, W.F., M. Tortorello, and T. Fu. ``Seed Sprouts: The State
of Microbiological Safety.'' Microbiology of Fresh Produce edited by
K.R. Matthews, pp 167-219. Washington, DC: ASM Press, 2006.
224. Gorski, L., J.D. Palumbo, and K.D. Nguyen. ``Strain-Specific
Differences in the Attachment of Listeria monocytogenes to Alfalfa
Sprouts,'' Journal of Food Protection 67 (11):2488-2495, 2004.
225. Charkowski, A.O., J.D. Barak, C.Z. Sarreal, and R.E. Mandrell.
``Differences in Growth of Salmonella enterica and Escherichia coli
O157:H7 on Alfalfa Sprouts,'' Applied and Environmental Microbiology
68 (6):3114-3120, 2002.
226. Liu, B., and D. Schaffner. ``Mathematical Modeling and
Assessment of Microbial Migration during the Sprouting of Alfalfa in
Trays in a Nonuniformly Contaminated Seed Batch Using Enterobacter
aerogenes as a Surrogate for Salmonella Stanley,'' Journal of Food
Protection 70 (11):2602-2605, 2007.
227. Hora, R., M. Kumar, L. Garcia, B. Schumacher, J. Odumeru, and
K. Warriner. ``Spatial Distribution of Salmonella, Escherichia coli
O157:H7, and Other Bacterial Populations in Commercial and
Laboratory-Scale Sprouting Mung Bean Beds,'' Journal of Food
Protection 68 (12):2510-2518, 2005.
228. California Department of Public Health and Food and Drug
Administration. ``Safer Processing of Sprouts Video.'' https://www.cdph.ca.gov/pubsforms/Documents/fdbIRfrm01.pdf, 2000.
229. Caudill Seed Company Inc. ``Sprouting Seed Production
Guidelines.'' accessed June 24, 2015. http://www.perishablepundit.com/docs/alfa-confirmationcontract.pdf.
230. Fu, T.J. ``Memorandum to File--Sprouters Who Grow Their Own
Seeds: Communication with Mr. Bob Sanderson, June 2015.'' Food and
Drug Administration.
231. European Commission. ``Commission Regulation (EU) No 211/2013
of 11 March 2013 on Certification Requirements for Imports into the
Union of Sprouts and Seeds Intended for the
[[Page 74546]]
Production of Sprouts.'' available at: http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2013:068:0026:0029:EN:PDF, 2013.
232. Johanson, J., and C. McKenna. ``Memorandum to the File--Review
of Literature on Methods for Treatment of Seed Intended for
Sprouting, October 2015.'' Food and Drug Administration.
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.
``Tribal Directory.'' last modified October 19, 2015. accessed
October 19, 2015. http://www.bia.gov/WhoWeAre/BIA/OIS/TribalGovernmentServices/TribalDirectory/.
247. Food and Agriculture Organization and World Health
Organization. ``Codex Committee on Food Import and Export Inspection
and Certification Systems (CCFICS).'' last modified May 10, 2015.
accessed June 26, 2015. http://www.codexalimentarius.org/committees-and-task-forces/en/?provide=committeeDetail&idList=5.
248. Food and Agriculture Organization and World Health
Organization. 2004. ``Codex Alimentarius Commission: Guidelines for
the Production, Processing, Labeling, and Marketing of Organically
Produced Foods.'' accessed June 2015. http://www.fao.org/docs/eims/upload/230124/CXg_032e.pdf.
249. European Medicines Agency. 2015. ``National Competent
Authorities (Human).'' last modified 2015. accessed June 26, 2015.
http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/general/general_content_000155.jsp.
250. ``Global GAP.'' accessed October 26, 2015. http://www.globalgap.org/uk_en/.
251. United Fresh Produce Association. ``Combined Harmonized Food
Safety Standard.'' last modified February 26, 2015. accessed June
26, 2015. http://www.unitedfresh.org/content/uploads/2014/07/Combined-Harmonized-Standard-5-column-150226.pdf.
252. United Fresh Produce Association. ``GAP Harmonization
Initiative.'' last modified 2014. accessed June 26, 2015. http://www.unitedfresh.org/food-safety/gap-harmonization-initiative/.
253. Food and Drug Administration. ``Operational Strategy for
Implementing the FDA Food Safety Modernization Act (FSMA).'' last
modified August 5, 2014. accessed June 26, 2015. http://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm395105.htm.
254. Food and Drug Administration. ``FSMA Public Meeting: Focus on
Implementation Strategy for Prevention-Oriented Food Safety
Standards.'' last modified July 17, 2015. accessed October 15, 2015.
http://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm438205.htm.
255. Food and Drug Administration. 2015. ``The Food and Drug
Administration Food Safety Modernization: Focus on Implementation
Strategy for Prevention-Oriented Food Safety Standards; Public
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
Agreement to Implement National Produce Safety Rule.'' last modified
September 16, 2014. accessed June 24, 2015. http://www.fda.gov/Food/NewsEvents/ConstituentUpdates/ucm414777.htm.
257. Food and Drug Administration. ``Tribal Summary Impact Statement
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.''
259. U.S. Department of Agriculture, ``Census of Agriculture,
2012,'' (http://www.agcensus.usda.gov), 2014. Accessed and printed
on October 29, 2015.
260. U.S. Department of Agriculture National Agricultural Statistics
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