This document is scheduled to be published in the
Federal Register on 11/27/2015 and available online at 
http://federalregister.gov/a/2015-28159
, 
and on 
FDsys.gov
4164 -01-P 
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.  
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 grow n for human consumption. FDA is 
establishing these standards as p art 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, prod uce that receives commercial processing that adequately reduce s 
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 minimiz e 
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  
2 
 such hazards. We expect the rule to reduce foodborne illness associated with the consumption of 
contaminated produce.  
DATES:  This rule is effective [ INSERT DATE 60 DAYS AFTER DATE OF PUBLICATION 
IN THE FEDERAL REGISTER ]. The effective date of § § 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 [INSERT DATE 60 DAYS AFTER DATE OF PUBLICATION IN THE FEDERAL 
REGISTER ]. The effective date of §§ 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 [INSERT DATE 60 DAYS 
AFTER DATE OF PUBLICATION IN THE FEDERAL REGISTER ]. 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 [ INSERT DATE 60 DAYS 
AFTER DATE OF PUBLICATION IN THE FEDERAL REGISTER ]. 
FOR FURTHER INFORMATION CONTACT: Samir Assar, Cen ter 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   
3 
 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 Co mments 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   
4 
 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 F ood 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 ( §§ 112.1 and 112.2, and Definition of 
“Produce” in § 112.3(c))  
B. Definitions Other Than Small Business, Very Small Business, Produce ( § 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 § 112.11  
B. General Comments About Alternatives in § 112.12  
C. Alternatives for Additional or All Requirements  
D. Addit ional Clarification  
E. Prior Approval of Alternatives  
XI. Subpart C – Comments on Personnel Qualifications and Training  
A. General Comments   
5 
 B. Qualification and Training for Personnel Who Handle (Contact) Covered Produce or 
Food -Contact Surfaces ( § 112.21)  
C. Training Personnel Who Conduct a Covered Activity (§ 112.22)  
D. Records Related to Personnel Qualifications and Training (§ 112.30)  
XII. Subpart D – Comments on Health and H ygiene  
A. General Comments  
B. Ill or Infected Persons ( § 112.31)  
C. Personnel Hygienic Practices (§ 112.32)  
D. Visitors (§ 112.33)  
XIII.  Subpart E – Comments on Ag ricultural Water 
A. General Comments  
B. General Agricultural Water Quality Requirement  (§ 112.41) and Corresponding 
Corrective Measures (§ 112.45(a))  
C. Agricultural Water  Sources, Water Distribution Systems, and Pooling of Water (§ 
112.42)  
D. Treatment of Agricultural Water (§ 112.43)  
E. Microbial Quality Criterion  for Agricultural Water Used for Certain Specified 
Purposes (§ 112.44(a)) and Corresponding Corrective Measures (§ 112.45(a))  
F. Microbial Quality Criteria for Agricultural Water Used for Direct Application During 
Growing Activities of Produce (Other Than Sprouts) ( § 112.44(b)) and 
Corresponding Corrective Measures (§ 112.45(b))  
G. Testing of Agricultural Water (§ 112.46)  
H. Sharing of Water Testing Data (§ 112.47(a))   
6 
 I. Agricultural Water Used During Harvest, Packing, and Holding Activities (§ 112.48)  
J. Records Related to Agricultural Water (§ 112.50)  
K. Compliance Periods Related to Agricultural Water  
XIV.  Subpart F – Comments on Biological S oil Amendme nts of Animal Origin and Human 
Waste 
A. General Comments  
B. Determining the Status of a Biological Soil Amendment of Animal Origin ( § 112.51)  
C. Handling, Conveying, and Storing Biological Soil Amendments of Animal Origin (§ 
112.52)  
D. Prohibitions Regarding Use of Human Waste (§ 112.53)  
E. Treatment Processes (§ 112.54)  
F. Microbial Standards Applicable to the Treatment Processes in § 112.54 (§ 112.55)  
G. Application Requirements and Minimum Application Intervals (§ 112.56)  
H. Records Related to Biological Soil Amendments of Animal Origin (§ 112.60)  
I. Other Comments  
XV. Subpart I – Comments on D omesticated and Wild Animals  
A. Subpart I and Prevention of Contamination  
B. Limited Scope of Applicability of Subpart I ( § 112.81)  
C. Grazing and Working Animals (§ 112.83)  
D. Animal Intrusion (§ 112.83)  
E. List of “Animals of Concern”  
XVI.  Subpart K – Comments on  Growing, Harvesting, Packing , and Holding Activities   
7 
 A. Growing, Harvesting, Packing, or Holding Both Covered and Excluded Produce ( § 
112.111)  
B. Harvest ing Covered Produce  (§ 112.112)  
C. Handling Harvested Covered Produce (§ 112.113)  
D. Dropped Covered Produce (§ 112.114)  
E. Packaging Covered Produce (§ 112.115)  
F. Food -Packing (Including Food Packaging) Material (§ 112.116)  
XVII.  Subpart L – Comments on Equipment, T ools, Buildings, and Sanitation  
A. Types of Buildings That are Subject to the Requirements of Subpart L ( § 112.122)  
B. Equipment and Tools (§ 112.123)  
C. Instruments and Controls Used to Measure, Regulate, or Record (§ 112.124)  
D. Equipment Used in the Transport of Covered Produce (§ 112.125)  
E. Buildings (§ 112.126)  
F. Toilet Facil ities (§ 112.129) and Hand -Washing Facilities (§ 112.130)  
G. Controlling Animal Excreta and Litter From Domesticated Animals (§ 112.134)  
XVIII.  Subpart M – Comments on S prouts  
A. General Comments  
B. Seeds or Beans Used to Grow Sprouts ( § 112.142)  
C. Growing, Harvesting, Packing, and Holding Sprouts (§ 112.143)  
D. Testing During Growing, Harvesting, Packing, and Holding Sprouts (§ 112.144)  
E. Environmental Testing for Listeria  Species or L. monocytogenes  (§ 112.145)  
F. Follow -Up Actions for Positive Environmental Testing Results (§ 112.146)   
8 
 G. Collection and Testing of Samples of Spent Sprout irrigation Water or Sprouts (§ 
112.147)  
H. Actions if Spent Sprout Irrigation Water or Sprouts Test Positive for a Pathogen ( § 
112.148)  
I. Records Related to Sprouts (§ 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 R ecords  
A. General Comments  
B. General Requirements Applicable to Records Required Under Part 112 ( § 112.161)  
C. Storage of Records (§ 112.162)  
D. Use of Existing Records (§ 112.163)  
E. Length of Records Retention (§ 112.164)  
F. Acceptable Formats for Records (§ 112.165)  
G. Disclosure of Records Submitted to FDA (§ 112.167)  
XXI.  Subpart P – Comments on V ariances  
A. Requesting a Variance ( §§ 112.171 and 112.172)  
B. The Statement of Grounds in a Variance Petition (§ 112.173)  
C. Process for Requesting a Variance (§ 112.176)   
9 
 D. Permissible Types of Variances ( § 112.182)  
E. Other Comments  
XXII.  Subpart Q – Comments on C ompliance and Enforcement  
A. General Comments on Compliance and Enforcement Strategy  
B. FDA Enforcement Decisions  
C. Coordination of Education and Enforcement ( § 112.193)  
D. On-Farm Inspections  
E. Third -Party Audits, Inspections, and Other Arrangements  
XXIII.  Subpart R – Comments on Withdrawal of Q ualified Exemption  
A. Circumstances That May Lead FDA to Withdraw a Farm’s Qualified Exemption ( § 
112.20 1) 
B. Contents of an Order to Withdraw a Qualified Exemption (§ 112.203)  
C. Compliance With, or Appeal of, an Order to Withdraw a Qualified Exemption (§§ 
112.204, 112.205, and 112.206)  
D. Procedure for Requesting an Informal Hearing ( § 112.207)  
E. Informal  Hearing (§ 112.208)  
F. Circumstances Related to Reinstatement of a Qualified Exemption That is Withdrawn 
(§ 112.213)  
G. Other Comments  
H. Conforming Amendment to 21 CFR Part 16  
XXIV.  Comments on Effective and Compliance Dates  
A. Effective and Compliance D ates for Part 112  
B. Effective Dates for Conforming Changes   
10 
 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 a dverse 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 dea th, 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 Cosm etic 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, an d holding of produce, meaning fruits and vegetables grown for human  
11 
 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 ru lemaking 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 conduct ed 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 :  
The rule does not apply to certain specified produce commodities that are rarely 
consumed raw.   
The rule also does not apply to produce that is used for personal or on -farm consumption, 
or that is not a RAC .    
12 
 The rule provides an exemption for produce that receives commercial processing that 
adequately reduce s 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 . 
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.   
The rule provides a qualified exemption and modified requirements for farm s 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 addres s 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 ke ep 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  
13 
 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:  
Worker Training and Health and Hygiene  
o Establish qualification and training requirements for all personnel who handle 
(contact) covered produce or food -contact surfaces and their supervisors (§§ 
112.21, 112.22, and 112.23);  
o Require documentation of required training and corrective actions (§ 112.30); and  
o Establish hygienic practices and other measures needed to prevent persons, 
including visitors, from contaminating produce with microorganisms of public 
health significance (§§ 112.31, 112.32, and 112.33).  
Agricultural Water  
o Require that  all agricultural water must be safe and of adequate sanitary quality 
for its intended use (§ 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 s urfaces (§ 112.3(c));  
o 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 cover ed 
produce (§ § 112.42  and 112.48 );   
14 
 o If a farm  choose s to treat agricultural water to meet relevant requirement s for its 
inten ded use, establish require ments related to  methods of treatment  and 
monitoring such treatment (§ 112.43);  
o Establish specific re quirements 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 speci fied 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 
requirement s (§§ 112.44, 112.45, 112.46 , and 112.47 ); and provide for the use of 
alternative requirements for certain provisions under certain conditions (§§ 112.12 
and 112.49); and  
o 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  (§ 112.50).  
Biological Soil Amendments  
o 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 (§§ 112.51 and 112.52) ;  
15 
 o 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 (§ 112.53);  
o 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 (§§ 112.54 and 112.55), 
including ex amples of such processes;  
o Establish application requirements and minimum application intervals for 
untreated and treated biological soil amendments of animal origin (§ 112.56); and  
o Require certain records, including documentation from suppliers of treated 
biological soil amendments of animal origin , documentation that process controls 
were achieved , and corrective actions  (§ 112.60).  
Domesticated and Wild Animals  
o If there is a reasonable probability that grazing animals, working animals, or 
anim al 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 f arm must identify, and not harvest , covered produce that is 
reasonably likely to be contaminated with a known or reasonably foreseeable 
hazard (§§ 112.83 and 112.112).  
Equipment, Tools, and Buildings  
o Establish requirements related to equipment and tool s that contact covered 
produce and instruments and controls (including equipment used in transport),  
16 
 buildings, domesticated animals in and around fully -enclosed buildings, pest 
control, hand -washing and toilet facilities, sewage, trash, plumbing, and anim al 
excreta (§§ 112.121 -134); and  
o 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  (§ 112.1 40). 
Sprouts  
o Establish scope of applicability of sprout provisions  (§ 112.141);   
o Establish  measures that must be taken related to seeds or beans for sprouting (§ 
112.142);  
o Establish measures that must be taken for the growing, harvesting, packing, and 
holding of sprouts (§ 112.143);  
o 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 (§§ 112.144 -112.148); and  
o 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  (§ 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,  
17 
 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 a re also providing extended compliance dates for certain specified 
requirements related to agricultural water.  In the compliance date s relating to the qualified 
exemption , the compliance date  for the records that a farm is required by § 112.7(b) to maintain 
to support its eligibility for a qualified exemption is the effective date of this rule, i.e., [INSERT 
DATE 60 DAYS AFTER DATE OF PUBLICATION IN THE FEDERAL REGISTER DATE ]. 
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 § 112.6(b)(1).    
 
Compliance Dates  
Size of 
covered 
farm  Covered 
activities 
involving 
sprouts 
covered under 
subpart M  
(i.e., subject 
to all 
requirements 
of part 112)  Covered activities involving all 
other covered produce ( i.e., 
subject to part 112, except 
subpart M)  Farms eligible for a qualified exemption (if 
applicable)  
Compliance 
date for 
certain 
specified 
agricultural 
water 
requirements  Compliance 
date for all 
other 
requirements  Compliance 
date for 
retention of 
records 
supporting 
eligibility in 
§ 112.7(b)  Compliance 
date for 
modified 
requirement 
in § 
112.6(b)(1)  Compliance 
date for all 
other 
requirements 
in §§ 112.6 
and 112.7  
Time periods starting from the effective date of 
this rule  
Very small 
business  3 years  6 years  4 years  Effective date 
of rule  
 January 1, 
2020  4 years  
Small 
business  2 years  5 years  3 years  3 years  
All other 
businesses  1 year  4 years  2 years  N/A 
 
  
18 
 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 ap proximately 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 prob lems 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  
19 
 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, Harvesting, Packing, 
and Holding of Produce for Human Consumption  2013 proposed produce 
safety rule or simply “2013 
proposed rule”  78 FR 3504, January 16, 
2013  
Current Good Manufacturing Practice and Hazard 
Analysis and Risk -Based Preventive Controls for 
Human Food  2013 proposed human 
preventive controls rule 78 FR 3646, January 16, 
2013  
Current Good Manufacturing Practice and Hazard 
Analysis and Risk -Based Preventive Controls for 
Food for Animals  2013 proposed animal 
preventive controls rule  78 FR 64736, October 29, 
2013  
Foreign Supplier Verification Pr ograms (FSVP) 
for Importers of Food for Humans and Animals  2013 proposed FSVP rule  78 FR 45730, July 29, 
2013  
Accreditation of Third -Party Auditors/Certification 
Bodies to Conduct Food Safety Audits and to Issue 
Certifications  2013 proposed third -party 
certification rule  78 FR 45782, July 29, 
2013  
Focused Mitigation Strategies To Protect Food 
Against Intentional Adulteration  2013 proposed intentional 
adulteration rule  78 FR 78014, December 
24, 2013  
Sanitary Transportation of Human and Animal 
Food  2014 proposed sanitary 
transportation rule  79 FR 7006, February 5, 
2014  
 
We also issued  supplemental notice s 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, Harvesting, Packing, 
and Holding of Produce for Human Consumption  2014 supplemental produce 
safety notice or simply 
“supplemental notice”  79 FR 58434, September 
29, 2014  
Current Good Manufacturing Practice and Hazard 
Analysis and Risk -Based Preventive Controls for 
Human Food  2014 supplemental human 
preventive controls notice  79 FR 58524, September 
29, 2014  
Current Good Manufacturing Practice and Hazard 
Analysis and Risk -Based Preventive Controls for 
Food for Animals  2014 supplemental animal 
preventive controls notice  79 FR 58476, September 
29, 2014  
Foreign Supplier Verification Programs (FSVP) 
for Importers of Food for Humans and Animals  2014 supplemental FSVP 
notice  79 FR 58574, September 
29, 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 hazar ds are  
20 
 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 regulat ions 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 presentation s 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 
engage s 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 radiolog ical) contaminants . Contamination of produce can occur on -farm during  
21 
 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 FS MA 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 introduc tion 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 provisi ons, to: 
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; equipment, tools, and 
buildings; and sprouts ; 
Focus the rule on microbiological hazards related to produce growing, harvesting, 
packing, and holding ; 
Apply proposed part 112  to bot h domestic and imported produce, with several 
exemptions, including that t he rule would not apply  to certain specified produce   
22 
 commodities that are rarely consumed  raw; produce that is used for  personal or on -farm 
consumption; or produce that is not  a RAC ;  
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;  
Not cover farms that have an average annual value  of food sold during the previous 3-
year period of $25,000 or less;  
Provide a  qualified exemption and modified  requirements for farms that meet certain 
requirements , as well as establish circumstances and procedures under which th is 
exemption may be withd rawn; and  
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 2469 2, April 26, 2013 ). 
We later extended the comment period to allow interested persons an opportunity to consider the 
interrelationships between the 2013 proposed prod uce safety rule  and the 2013 proposed FSVP 
and t hird-party certification  rules (78 FR 48637, August 9, 2013 ). We also issued a notice 
correcting several typogra phical, 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.   
23 
 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 asses sment , and asked 
for public c omment on our assessment and findings  (78 FR 3504, January 16, 2013 ). The 
tentative conclusions of this assessment  inform ed our proposed science -based minimum 
standards for the safe production and harvesting of produce commodit ies.  
 
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 th e 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 : 
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;   
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 ownersh ip;   
24 
 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 ;  
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 ;  
Amendment to remov e the 9 -month  minimum application interval for use of  raw manure  
and other untreated biological soil amendments of anim al origin , and d efer FDA’s  
decision  on an appropriate time interval until  FDA  takes certain specified actions;  
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  
New provision s 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 supplemen tal notice . In addition, we 
emphasized that the new and amended proposed provisions we included in the regulatory text  
25 
 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 sa fety 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.  
Table 3.-- List of Federal Register Publications Regarding the Proposed Produce Safety  Rule  
Description  Publication  
2013 proposed produce safety  rule, requesting comments by May 16, 
2013  78 FR 3 504, January 16, 2013  
Notice of public meeting (held in Washington D.C. on February 28, 
2013) on the 2013 proposed preventive controls rule and the 2013 
proposed produce safety rule  78 FR 6762, January 31, 2013  
Notice of public meetings (held in Chicago, IL on March 11, 2013 
and in Portland, OR on March 27, 2013) on the 2013 proposed 
preventive controls rule and the 2013 proposed produce safety rule  78 FR 10107, February 13, 2013  
Notice extending comment period, until May 16, 2013, for the 
information collection provisions of the 2013 propose d produce safety 
rule 78 FR 11611 , February 19, 2013  
Notice of correction for the 2013 proposed produce safety rule 78 FR 17155 , March 20, 2013  
Notice extending the comment period, until September 16, 2013, for 
the 2013 proposed produce safety  rule and i ts information collection 
provisions  78 FR 24692 , April 26, 2013  
Notice extending the comment period, until November 15, 2013, for 
the 2013 proposed produce safety  rule and its information collection 
provisions  78 FR 48637 , August 9, 2013   
26 
 Description  Publication  
Notice extending the comment period, until November 22, 2013, for 
the 2013 proposed produce safety  rule and its information collection 
provisions  78 FR 69605 , November 20, 2013  
Produce safety supplemental n otice, requesting comments by 
December 15 , 2014  79 FR 58434 , September 29,  2014  
Notice of public meeting (held in College Park, MD  on November 13, 
2014 ) on the human preventive controls supplemental notice, produce 
safety supplemental notice, animal preventive controls supplemental 
notice, and FSVP supplemental notice  79 FR 63346 , October 23 , 2014  
 
 
 
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 doc ument , 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 f irms; 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  
27 
 statements from m ultiple 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 e xplain 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 response s 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 commen ts 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, foreig n 
supplier v erification 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   
28 
 The final rule requires that, to rely on the exemption in § 112.2(b) for produce that 
receives commercial processing that adequately reduce s the presence of microorganisms of 
public health concern, a covered farm must disclose in documents accompanying the produce 
that the food is “not process ed to adequately reduce  the presence of microorganisms of public 
health significance” (§ 112.2(b)(2)). This requirement is authorized by  section s 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 pro duce 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 c hain 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 applie d. 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 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 S tate 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   
29 
 We are using our au thority 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 
eligibl e 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 far m’s continued 
eligibility for the qualified exemption (§ 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 § 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 §§ 
112.50(b)( 6) and 112.150(b)( 6). Moreover, in § 112.50(b)(6), we ar e also establishing specific 
requirements for d ocumentation of any time interval or (calculated) log reduction applied in 
accordance with § 112.45(b)(1)(i) and/or (b)(1)(ii), including the specific time interval or log 
reduction applied, how the time inter val 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 activi ties such as commercial washing . 
In addition, we note that the revised records requirements in § 112.2(b) include:  (1) For 
farms relying on the exemption in § 112.2(b), documentation of disclosures required under § 
112.2(b)(2) and annual written assurances obtained from customers under § 112.2(b)(3) (§ 
112.2(b)(4) ); and  (2) For entities that provide a written assurance under § 112.2(b)(3), 
documenting actions taken to satisfy the written assurance  (§ 112.2(b)(6)) .    
30 
 As discussed further in the 2013 proposed rule and in sections  XI, XIII, XIV, XVII , and 
XVIII  of thi s 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 ind ustry 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. Becaus e 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   
31 
 (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 r ule 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 pla in 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 no t 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, sugges ts 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 pro vides 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.   
32 
 FDA is mindful that its interpretation of FSMA and the FD&C Act should not cast doubt 
on the ir 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 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 impac t 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 
qualifi ed exemption in § 112.5, or if the farm only grows produce exempt from the regulation 
under one of the exemptions in § 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 A ct’s requirements respecting foods, drugs, devices, and cosmetics, any 
necessary connection with interstate commerce is presumed. Likewise, this outcome is consistent  
33 
 with FSMA’s risk -based, preventive approach to food safet y 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 i n § 112.2(b)(6) that the 
entities that provide written assurances described in § 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 ot her entities that voluntarily agree to provide the written 
assurances described in § 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, 
complyi ng with, and documenting compliance with the written assurances described in § 
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 section s 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 consi stent 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  
34 
 Controls for Huma n 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 Fo od 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 A ct (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 sp ecific 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 th is rule to 
help covered farms  to understand and implement this rule , particularly in the area s of agricultural 
water, personnel training, domesticated and wild animals, sprout production, and biological soil 
amend ments  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.  Comment s 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 suppor t for ongoing education and outreach, including taking an active role in providing 
needed instructional examples and lessons learned from current investigations and foodborne 
outbreaks.   
35 
 (Response)  We are developing guidance documents, including general gu idance 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 commo dities, 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 guidance s 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 (§ 10.115(g)(5)).  
We agree with comments that stress the importance of education and outreach. 
Supporting efforts to help  covered farm s get the education and technical assistance they need to 
understand and implement the requ irements 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 in formation 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 th is rule . 
We continue to work with other government agencie s, 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  
36 
 Agriculture (USDA) and others, h as 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 farm s 
with fundame ntal, on -farm food safety knowledge and equip them to comply with the produce 
safety regulation . FDA is working to ensure that the PSA and SSA training materials (which we 
refer to collectively as “the Alliance courses”) are consistent with the requirement s 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 disadva ntaged 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 universitie s, 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 ve ry 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.   
37 
 (Comment 4) Some comments ask us to establish and annually convene a scientific 
workgroup that includes experts in produce product ion, 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 pro vide 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 regula tions 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 updatin g 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 ne ed 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 infor mation becomes available. One 
commenter requests that FDA establish a process for such review and update.   
38 
 (Response)  FDA may, on its own initiative or in response to a petition from an interested 
person, initiate administrative proceedings to amend existin g 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 hav e 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 a gricultural 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 underst anding 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 acknowle dge 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 m icroorganism” includes those 
microorganisms that are of public health significance, that subject food to decomposition, that  
39 
 indicate that food is contaminated with filth, or that otherwise may cause food to be 
adulterated. The produce safety standards est ablished in this rule focus on minimizing the risk 
of contamination of produce with microorganisms that can cause serious adverse health 
consequences or death , and a re 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, an d 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 § 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 a re 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.   
40 
 (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 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 o ther 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 t here 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 approv als. 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 § 112.4 6, for testing  for 
Listeria  spp. or L. monocytogenes  to satisfy the requirements of § 112.144 (a), and  for testing 
for certain pathogens to satisfy the requirements of § 112.144(b)  and (c) , provided they meet 
certain conditions in accordance with §§ 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  
41 
 for detecting and identifying microorganisms of public health significance. These c omments 
argue that if there are no criteria for training and appropriate us e of testing devices or 
interpretation, test results may not be reliable. These comments also suggest posting a list of 
accredited laboratories on FDA’s website for use by farms.  
(Response)  We are currently working on a proposed rule to implement section 2 02 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 crit eria 
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 assessmen t 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, s ome 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.  
42 
 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 divers ity, 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 A merican 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 t hat 
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 man ufacture, 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 exce pt for farms that produce milk (per section 420 of 
the FD&C Act) (78 FR 78014).  
C. Registration   
43 
 In the 2013 proposed produce safety rule, we requested comment on whether we should 
require that covered farms, as described in proposed § 112.4(a), register w ith 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 regis tration would be most helpful during response activities associated with 
illness outbreaks and recalls. These c omments 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 o f 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 t o register with FDA, stating that such a 
requirement would be unreasonable and inconsistent with FSMA. These comments argue that 
FSMA does not authorize FDA to require farms to register with FDA, and that FDA fails to 
establish how requiring farms to regis ter would contribute to improved food safety outcomes in 
produce production. Other comm ents suggest that FDA has many S tate and federal partners to 
assist in reaching out to the produce production community, and that there are existing industry  
44 
 resources, which include lists of producers. Some  comments state that local and S tate 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, w e 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 suf ficient 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 en hance 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 farm s 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 farm s from following NOP 
standards, including the provisions in NOP’s regulations at 7 CFR 205.200, 205.205, and 20 5.2.  
45 
 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 requiremen ts. 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 Ser vice (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  
46 
 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 conser vation 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 adver se 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 
conservati on 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 conflic t 
with federal or State programs. In addition, by including § 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 prac tices in violation of the ESA ,  
47 
 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 field s.  
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 § 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 Testi ng as a Strategy to Control Pathogens  
(Comment 16) Some  comment s 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 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 farm s and FDA to monitor for trends, correct 
imbalances or inaccuraci es, 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  
48 
 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 dom esticated and wild animals in subpart I. These c omments 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 aqua ponic 
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; aqu aponic 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 comm ents state that fish waste does not contain E. coli and, 
therefore, the water microbial quality and testing requirements in proposed §§ 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  
49 
 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 acknowled ge 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 
aquapon ic 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 grow n 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 § 112.44  and the relevant water testing requiremen ts in § 112.46 . Also, as 
discussed further in  Comment  222, the § 112.46(a) exception from water testing requirements 
applies only when water received from a public water system (as in § 112.46(a)(1)) or a public 
water supply (as in § 112.46(a)(2)) is not h eld under your control in a way that meets the 
definitions of “ground water” or “surface water” before you use it as agricultural water. For  
50 
 example, where under the circumstances the water used in the aquaponic system is “agricultural 
water” (because it i s 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 § 112.46. For example, the testing requirements in § 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 be come  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 
susce ptible 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 agricul tural 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  
51 
 (when the water meets the definition of agricultural water) an d the requirements related to 
harvesting in § 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 § 112.81 to specify 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 
circumsta nces, 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 safe r 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 § 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  
52 
 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 t he 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 implement ing 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 Pract ice 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  
53 
 and safety considerations associated with aquaponics, generally, as well as with hydroponic 
production of crops other than sprouts, are sufficiently addressed through the provisi ons 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 § 
112.112 . We will consider issuing guidance on these  topic s in the future, as appropriate. 
Aquaponic and/or h ydroponic operations growing produce other than sprouts may also 
voluntarily choose to follow the standards in su bpart 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 assoc iated 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 cl asses 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  
54 
 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 believ e 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 string ent 
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 presen t 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 t he 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.   
55 
 We requested comment on our tentative conclusions related to our proposed regulatory 
approach. W e 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 t o 
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 d ata 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 exemption s 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 facto rs, such as adhesion and infiltration. Some comments also express  
56 
 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 ta rgeted 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 micr obial 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 c omments 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 co mmodities that present a greater risk profile. 
Some c omments 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 strateg ies 
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, c rop-specific standards  
57 
 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 f act, 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 t he 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 rout es 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  
58 
 good indicators of an association, or lack thereof, with outbreaks. Commenters also did not 
provide information affecting this conclusion. The QAR looked at like lihood 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 ev idenced by past association with an outbreak 
for a range of commodities with variable characteristics. For example, i f 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 201 4, there have  
been a total of 20 outbreaks in the United States  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 ) imp licated 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” commodit ies are assoc iated 
with outbreak s 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 p ast association with an outbreak 
to define a subset of low risk commodities that would be exempt from the requirements of part  
59 
 112. However, these comments did not provide data that affected the findings of the QAR, and 
in finalizing this rulemaking we con tinue 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 
consequence s 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 potentia l 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 onl y 
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 oth er 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 adequ ately addressed to allow development 
of a commodity -specific approach that would be sufficiently protective of public health. As a  
60 
 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 cons umed 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 t he 
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 pee l, 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 banana s 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 lowe r 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  
61 
 ground, may be rele vant 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 ra nked 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 commod ities 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 commodit ies due to 
the fact that they are  acidic, ha ve a rarely consumed peel, are grown in trees, irrigation water 
generally does not touch the fruit , and citrus fruits have  not been associated with  outbreak s. 
However, t he 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 commo dities 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 additio n, 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 GAP s, see Comment   
62 
 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 characterized as l ow 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 (§§ 112.2(a)(1) and (b)) . We are not 
establishing an additional process  or exemptions . 
(Comment 22) We received numerous comment s 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 
requirem ents 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  § 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, giv en 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 goo d manufacturing practices -type provisions, especially where the routes 
of contamination are well -understood and appropriate measures are well -established and  
63 
 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 conditi ons 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 § 112.83 and inspection of agricultural water system in § 112.42). In still 
other cases (e.g., sprouts), ou r 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 aga inst 
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 stand ards 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 tai lored, 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 tak ing into account their specific commodities and 
conditions in their operations , and risk profile associated with them . For example, we defin e 
“agricultural water,” in relevant part, to mean  water that is intended to, or likely to, contact the  
64 
 harvestable p ortion 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 qu ality 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 f lexibility to accommodate future 
changes in science and technology and the particularities of local growing conditions and 
commodities. Under § 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 § § 
112.12( a) and 112.49(a) , alternatives are permitted to the microbial quality criteria in § 
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 Un ited 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 accoun t 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, § 112.45( b)(1) provide s 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  
65 
 die-off between last irrigation and harvest and/or microbial reductio n 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 diver sity 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 thre shold, 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 produc e safety regulation. This regulation does not apply to those businesses with 
$25,000 or less in sales of produce, as described in § 112.4(a), because such farms do not 
contribute significantly to the produce market and, therefore, to the volume of producti on 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 fr om 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 requirements, as described in §§ 112.5, 112.6, and 
112.7.  
In additio n, 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  
66 
 not require that produce to be subject to the requirements in part 112. We are exempt ing 
produce commodities that are rarely consumed raw (§ 112.2(a)(1)) . Produce that receives 
commercial processing that adequately reduce s the presence of pathogens is also eligible for 
exemption under certain conditions (§ 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 thos e 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 scient ific 
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 cert ain 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 §§ 112.44, 
112.45, 112.55 and 112.56, are too prescriptive and inflexible to be codified in the regulation.  
67 
 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 me trics 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 comm ents 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 §§ 112.44, 112.4 5, 
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 § 
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 §§ 112.44, 
112.45, 112.46, and 112.55. For a discussion of t he 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 s uch 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 th e Rule   
68 
 (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 2 010. 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 outb reak 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 produ ction 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 r eview 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 o ne component of 
what we mean by the term “scientifically valid;” however, we continue to believe that peer - 
69 
 reviewed literature may be an important source of validation of, for example, a procedure, 
process, or practice allowed as an alternative to a specif ic requirement of this rule under §  
112.12.  
(Comment 27) Some comments suggest we should revise the regulation to align with 
what the commenter s identif y 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 brin g 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 a lso 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.  
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  
70 
 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, i ncluding 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 “immedia te 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 farmi ng 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 le afy 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  
71 
 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, includi ng 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 docum ented. 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  addre sses 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 t raceback after illness occurs.   
72 
 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 touc h 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 likel ihood 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 § 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 
previous ly 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 o f 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. Thes e 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   
73 
 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 n umber of 
other regulations with which farm s 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 fruits and vegetables, that are RAC s for which the 
Secretary has determine d 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 farm s 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 oper ators 
sufficient flexibility to tailor their practices as appropriate to achieve compliance with the 
applicable produce safety standards. Moreover, g uidance will play an important role in  
74 
 providing recommendations to assist farms in tailoring thei r 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 auditi ng 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 inspect ions 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  
75 
 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 wi th 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 consid ering 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 de velop 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 f or small and mid -
sized agricultural operations, and express concern about the burden of the rule on small farms  
76 
 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 “in dustrial 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, harve sting, 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 (§ 112.4(a) ) and a qualified exemption and corresponding modified requirements (§§ 
112.5, 112.6, and 112.7), a s well as  extended compliance periods (s ee 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 pract ices as appropriate. Our record keeping 
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 techn ical assistance to farmers is important. As 
mentioned throughout this document, FDA will be issuing guidance, including SECG,  
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 specifically aimed at assisting small and very small farms to comply with the requ irements of 
this rule. See also Comment 3  and section s XI and XXII  of this documen t. 
 
(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 comp ared 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 req uirements 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” definiti on 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 § 112.4(a) is not 
covered under this rule. Mor eover, under § 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 
sectio n XXIV  of this document. All of these factors will reduce the burden of this rule on small  
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 farms.  
 
H. Estimated Produce Outbreaks and Associated Illnesses  
(Comment 33) Several comments question our analysis and estimates of produce -related 
outbreak illness es. 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 ill nesses 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 cons ideration 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 sh ould 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 d ata also do not include a large number of reported illnesses/outbreaks where the 
contaminated food veh icle cannot be determined. The d ata 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 outbrea ks 
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  
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 of this rule. Our goal is to minimize illnesses and deaths associa ted 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 t hese illnesses for purposes of the Regulatory Impact 
Analysis (RIA) for this rule, we are otherwise considering them in our assessment in th e QAR 
and in establishing th is rule. We have determined that it is most appropriate to attribute the 
benefits of avo iding 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 syst em 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 th is rule 
and the PCHF r egulation  even tho ugh the economic benefits of avoiding illnesses attributable 
to such products are b eing 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 o f animal origin. These comments urge FDA 
to remove restrictions applicable to these methods of farming, absent data showing an actual,  
80 
 verified increased rate of foodborne illness associated with use of such. In addition, these 
comments argue that FDA is i nappropriately 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 wor king 
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 th at 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 far mers 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 tai lor 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 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 p artners on  
81 
 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 farm s 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 standardi zation 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, in cluding 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  
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 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 pr oduce 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 contaminati on) 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) W hat 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 consider ed peer reviewers' comments as well as  public comments  received  in 
response to t he 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  
83 
 system used in the draft QAR and updating the datasets for outbreaks and farm investigations to 
include data through 2014, to have imp roved 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 ar e: (1) Produce can be contaminated with biological hazards, and the vast 
majority of produce -related illnesses are ass ociated with biological hazards; (2) t he known routes 
of contamination from growing, harvesting, and on -farm postharvest activities are as sociated 
with seed (for sprouts), water, soil amendments, animals, worker health and h ygiene, and 
buildings/equipment; (3) a lthough 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 po tential routes of contamination; (4) t he 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 c ontamination 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.   
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 Potential routes of contamination  -- Based on our observations during inspections, 
investigations, and surveillance activities and o ther 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 depen dent 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 o f 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) . Postharvest practi ces 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 dif ferences 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 s ame characteristics. Both categories include:  
Crops where the harvestable portion grows in the ground;  
Row crops where the harvestable portion grows on or near the ground;   
85 
 Crops where the harvestable portion grows above the ground;  
Crops where the harvestable portion grows on trees, high above the ground; and  
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 diversit y 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 outbrea k, 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; 
consu mer 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 iden tifies 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; an d prevalence and 
levels of pathogens in produce that cause illness .  
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 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 rout es 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 wat er. 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 quali ty 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 § 112.44. In this rule, we ar e finalizing those proposed  
87 
 requirements, with revisions, consistent with our updated supporting analyses (see section X III 
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 r isk 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 ad ulterated 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-biolog ical 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 radio logical)”  
88 
 throughout this rule. This reference to radiological hazards as a subset of  chemical hazards is 
consistent with how these hazards are considered in t he PCHF regulation (see definition of 
“hazard ” in § 117.3). 
 
(Comment 37) Several comments genera lly 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 the re 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 farm s are 
already regulated at both the State and federal levels in their use of agricultural chemicals, and 
this 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 conse quences 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.  
89 
 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 ris k 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 cont inue 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 
recommenda tions 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 no te 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  
90 
 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 refer s 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 t he 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 wit h 
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.   
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 (Response)  We disagree. Focusing the produce safety regulation on biological hazards 
is consistent with sec tion 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 practice s 
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 sectio n 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 deat h 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 concl ude 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  
92 
 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 o f 
hazards, in light of local, regional or country -wide 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 req uirement in §  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 exampl e, 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 contamina ted 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  
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 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 neces sarily 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 assessm ent 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.  
  
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 (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 contam ination 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 Guid e addresses previous land use 
including animal grazing, chemical application, and toxic spills. In addition, at the request of 
some forei gn 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 s ection 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 necessaril y 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  
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 evidence on the negative impacts of agricultural chemical use on public health. Other comments 
express concern over other chemical hazards, such as thos e 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 no t 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 u ses 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 mea t, poultry, and some egg products. As mentioned previously, FDA also routinely  
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 monitors for chemicals, pesticide residues, metals and radionuclides through its regulatory 
monitoring programs, with an emphasis on RACs and foods consumed by infants and child ren 
(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 pro gram 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 release d 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  
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 noted in that report, FDA has already undertaken certain actions to enhance its program. For 
example, FDA has increased its mon itoring 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 test ing. 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 h azards 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 com ments 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 demon strate 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  
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 occurre nce 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 F arm-Specific F ood 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 requir e 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 t his 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 farm s 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 alr eady 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  
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 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 comme nts 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 alr eady 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 ca n 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 food safety plans. For example, in the GAPs Guide, we stated that the 
recommendations in that guide would be most effective if farm s 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 ass essment  
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 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 prac tices; 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 be lieve, 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 A nalysis 
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 introd uction of hazards and provide reasonable assurances  
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 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 A Z LGMA, the  Association of Food and Drug Officials’ (AFDO) Model Code of Practice for 
the Pr oduction 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 m ost 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 th an 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 safe ty 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 th ose 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  
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 workshop that can be added to their basic training on the assessment and food safety plan 
development process. We also acknowledge the effo rts 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 enforc ement, 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 t hat 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 wit h 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  
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 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 usefu l 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 subj ect 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 § 112.201. As established in § 
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 detentio n, 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 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 compl y 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 p revent ive controls rule. The commenter explains that, instead of following the 
prescribed standards, a covered farm would have the option to demonstrate and document the  
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 identification of its risks through its unique hazard analysis, and maintain adequate scient ific 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 pro posed § 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 s afety 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 § 112.12) could be applied to the specific operations at the farm. Note, however, 
section § 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 
comment er’s suggestion that we sh ould 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 alternati ve 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  
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 provisions FDA is establishing in this rule are those that FDA has determined are a ppropriate 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 § 112.12.  
 
(Comment 49) One comment suggests that national and regional crop associations should 
have the flexibility to add commodity ‐specific and risk -based standards to FDA -prescribed 
standards to fit their own crop(s), as necessary. This comment ma intains 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 doe s 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 § 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 additio n 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 ‐specific, risk -based recommendations, as n eeded 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  
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 consideration, similar to our d evelopment 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 regardi ng 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 (subpar t 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 
issue s 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 disadva ntage. 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.   
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 (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 enforc ement, 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 
domesti cally - 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 farmer s 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, tr ade associations, foreign partners, 
JIFSAN, and federal agencies (such as USAID and USDA), among others).  
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, su ch 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  
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 regulation) or is produced in accordance with processes and procedures that ensure the sam e 
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 
certifica tion 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 req uirements. 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 veri fication 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 en sure 
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 practic es. Instead, the comment asserts  
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 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 d omestic 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 th e 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 criteri a, 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 co nditions 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 cove rs pro duce 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  
110 
 domes tically 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 req uirements 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 produ ction 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 secti on 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 r isk 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 .  
  
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 (Comment 54) Some comments argue that imported produce should be more closely 
monitored than domestically -grow n 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 cove rs 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.  
 
(Comment 55) One comment asks FDA to clarify the applicability of the rule to a foreign 
farm t hat 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/re packaging 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  
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 that FDA should provide training and capacity building programs for foreign govern ments. 
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 no ted 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 outrea ch 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 rea ch 
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 wi th this rule. We also intend to disseminate guidance 
documents in multiple languages.  
IX. Subpart A – Comments on Definitions and General Provisions   
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 In proposed subpart A of part 112, we proposed to establish provisions that establish the 
scope of, and de finitions 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 eligi ble 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  
§ 112.1(b)(1)  - Revisions to the list of examples of fruits and 
vegetables  
§ 112.2(a)(1) – exhaustive 
list of rarely consumed raw 
produce  - Revisions to the list of exempt commodities based 
on our updated robust analysis using more recent 
data and information, and considering public 
comments  
§ 112.2(b) – produce that 
receives commercial 
processing  - Addition of wine and beer as examples in § 
112.2(b)(1)  
- New provisions § 112.2(b)(2), (3), and (4) to 
require certain disclosure and documentation, and 
annually obtain certain written assurances  
- New provision § 112.2(b)(6) related to entities 
that provide the written assurances described in § 
112.2(b)(3)(i) or (ii)  
§ 112.3(b) – Definition of 
“small business” and “very 
small business”  - Revision to acknowledge that such businesses 
may be subject to only some requirements of part 
112 if the farm is also eligible for qualified 
exemption.  
§ 112.3(c) – Definition of 
“agricultural tea”  - Revision to add “Agricultural teas are soil 
amendments for purposes of this rule”  
- Revision to replace “humus” with “stabilized 
compost”  
- Revision to specify that agricultural teas are soil 
amendments for th e purposes of this rule  
§ 112.3(c) – Definition of 
“biological soil 
amendment”  - Revision to replace “humus” with “stabilized 
compost”  
§ 112.3(c) – Definition of 
“biological soil amendment 
of animal origin”  - Revision to add animal mortalities as an exam ple 
§ 112.3(c) – Definition of 
“composting”  - Revision to replace “humus” with “stabilized 
compost”  
§ 112.3(c) – Definition of 
“covered activity”  - Revision to reflect new § 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.”   
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 § 112.3(c) – Definition of 
“curing”  - Revision to replace “maturation” with “final”  
- Revision to add “Curing may or may not i nvolve 
insulation, depending on environmental 
conditions.”  
§ 112.3(c) – Definition of 
“farm”  - Revision consistent with changes made in PCHF 
regulation  
§ 112.3(c) – Definition of 
“ground water”  - New definition of “ground water” added, with 
corresponding  changes to definition of “surface 
water”  
§ 112.3(c) – Definition of 
“growth media”  - Revision to replace “humus” with “stabilized 
compost”  
§ 112.3(c) – Definition of 
“harvesting”  - Revision consistent with changes made in PCHF 
regulation  
§ 112.3(c) – Definition of 
“hazard”  - Revision to more clearly distinguish “hazard” 
from “known or reasonably foreseeable hazard” 
by replacing “is reasonably likely to” with “has 
the potential to”  
§ 112.3(c) – Definition of 
“holding”  - Revision consistent with changes  made in PCHF 
regulation  
§ 112.3(c) – Definition of 
“known or reasonably 
foreseeable hazard”  - Replacing the term “reasonably foreseeable 
hazard” with “known or 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  
§ 112.3(c) – Definition of 
“manufacturing/processing”  - Revision consistent with changes made in PCHF 
regulation  
§ 112.3(c) – Definition of 
“mixed -type facility”  - Revision consistent with changes made in PCHF 
regulation  
§ 112.3(c) – Definition of 
“monitor”  - Revision to replace the phrase “when applicable” 
with “when required”  
§ 112.3(c) – Definition of 
“non -fecal animal 
byproduct”  - Revision to replace “other tha n excreta” with 
“other than manure”  
§ 112.3(c) – Definition of 
“packaging” (when used as 
a verb)  - Deleted consistent with changes made in PCHF 
regulation  
§ 112.3(c) – Definition of 
“packing”  - Revision consistent with changes made in PCHF 
regulation  
§ 112.3(c) – Definition of 
“produce”  - Revision to add “primarily” before “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  
§ 112.3(c) – Definition of 
“qualified end -user”  - Revision to add “or the same Indian reservation”  
- Revision  to move “The term ‘consumer’ does not 
include a business” from under (ii) into a 
parenthetical phrase within the definition   
§ 112.3(c) – Definition of - Revision to refer to adequately treating “surfaces”  
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 “sanitize”  rather than “food -contact surfaces,” consistent 
with changes made in PCHF regulation  
§ 112.3(c) – Definition of 
“stabilized compost”  - Revision to use the term “stabilized compost” 
rather than proposed term “humus” to better 
reflect the finished product of composting  
§ 112.3(c) – Definition of 
“soil amendment”  - Revision to replace “humus” with “stabilized 
compost”  
§ 112.3(c) – Definition of 
“static composting”  - Revision to replace “covered with at le ast 6 inches 
of insulating material” with “that may or may not 
be covered with insulating material”  
- Revision to replace “humus” with “stabilized 
compost”  
§ 112.3(c) – Definition of 
“surface water”  - Revision corresponding to new definition of 
“ground wa ter,” to clarify the differences between 
the two sources  
§ 112.3(c) – Definition of 
“turned composting”  - Revision to replace “humus” with “stabilized 
compost”  
§ 112.3(c) – Definition of 
“visitor”  - New definition of “visitor” added, with 
corresponding deletion of proposed definition that 
previously appeared in § 112.33(a) (content of 
final definition is unchanged)  
§ 112.3(c) – Definition of 
“you”  - Revision to clarify that “you” as 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”  
§ 112.4  - Revision to adjust the monetary threshold for 
inflation  
- Revision to reflect revised definition of “you”  
§ 112.5   - Revision to reflect revised definition of “you”  
§ 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 § 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”  
§ 112.7  - New provision to establish certain recordkeeping 
requirements in relation to qua lified exemption  
 
A. Food That is Covered and That is Not Covered (§§ 112.1 and 112.2, and Definition of 
“Produce” in §  112.3(c))  
1. Definition of “Produce” (§ 112.3(c)) and Food That is Covered (§ 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  
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 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 (Sept ember  8, 2000) (“Although seeds are clearly 
part of the plant kingdom, they ar e 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 dicti onary 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 rath er 
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 determining whether peanuts or tree nuts  
117 
 should be con sidered 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 § 
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 docu mentation) because they receive commercial 
processing that adequately reduce s the presence of microorganisms of public health significance 
under § 112.2(b).  
 
(Comment 58) Some comments ask whether “produce” includes food grains, algae, dry 
legumes, and foo d 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 20 13 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 (suc h as oil or flour ) and consumed  
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 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 
reduce s 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 pa rt 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, whe at, 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 (ha rvested 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  
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 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 see n 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 s cope 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 § 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 § 112.2(a)(1).   
120 
 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 appli es. 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 § 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 reduce s 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 § 112.2(b).  In addition, dried b eans are 
distinct commodities from fresh beans and are therefore processed foods. Processed foods are 
not subject to this rule (see § 112.2(a)(3)) , such that once beans subject to this rule are 
dried/dehydrated, the y are no longer subject to this rule .  
We also consider that lentils fit within the definition of produce. Lentils are the edible 
part of a n herbaceous plant grown for an edible part, and are the harvestable or harvested part 
of the 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 § 112.2(a)(1).  
The definition of “produce” in § 112.3 and the provisions for produce that is not  
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 covered under this rule in § 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 reduce s the presence of microorganisms of public 
health signi ficance (§ 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 § 112.2(a)), may be eligible for exemption under § 112.2(b) i f 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 § 112.2(b) (i.e., it receives commercial proce ssing that adequately reduce s 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 
§ 112.2(a)(3)), such that once produce RACs subject to this rule are made into processed foods , 
those processed foods  are no t 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 h arvestable 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  
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 provisions of subpart A, they are covered produce subject to the requirements of this rule.  
 
(Comment 60) One comment questio ns 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 Ric o. 
This includes produce RACs that are grown domestically for export to foreign countries.  
 
2. Produce That is Covered and Not Covered (§ 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 § 112.2 . 
This comment argues that people are consuming more fruits and vegetables to maintain a 
healthier diet, and thus all fruit and vegetables sh ould 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 §§ 112.2(a)(1) and 112.2(b), we exempt, or make eligible for 
exemption, produce that po se little to no risk of foodborne illness, either because it is rarely 
consumed raw (§ 112.2(a)(1)) (see section IX.A.3 of this document) or because it receives 
commercial processing that adequately reduce s the presence of pathogens (§ 112.2(b)). We 
conclu de 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 F D&C Act. In  
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 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 (§ 
112.2(a)(2)), and produce that is not a raw agricultural commodity (§ 11 2.2(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 § 112.2 is and will continue 
to be covered under the adulteration provisions and ot her 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 (§ 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 co mment, would be similar to the s eafood HACCP r egulation . 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 believe s 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 unde rgo a processing step that adequately reduce s the 
presence of microorganisms of public health concern.   
124 
 (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 pa rt 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 res ult, 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 informatio n or scientific data suggesting that cross -
contamination at retail or during food preparation in the home represent a significant concern for 
any of the commodities that we are identifying as “rarely consumed raw” produce. The 2013 
FDA Model Food Code incl udes 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 § 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 r egulations, 
irrespective of whether they are included within the scope of this rule.  
  
125 
 (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 § 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 
mann er 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 i ncluded 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 therefo re 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.  
(Resp onse)  We considered and rejected the possibility of providing a list of rarely 
consumed raw commodities in guidance without establishing any specific criteria for what  
126 
 “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 su bject 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 t he purposes of clarity of coverage and could present 
challenges for compliance and enforcement. The compl exity of the analysis (see  Ref. 73)  
necessary to obtain consumption patterns that consistently and adequately represent consumption 
among consumers acr oss 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 § 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, s uch 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 consum ers 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 n ot 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 State s.  
127 
 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, § 112.2(a)(1) lists the following produce as rarely consumed raw among 
United States  consumers: asparagus; bean s, black; bean s, great Northern; bean s, kidney; bean s, 
lima; bean s, navy; bean s, pinto; beet s, garden (roots  and tops); beets, sugar; cashew s; cherr ies, 
sour; chickpea s; cocoa bean s; coffee bean s; collards; corn, sweet; cranberr ies; dates; dill (seed s 
and weed); eggplant s; figs; ginger; hazelnut s; horseradish; lentil s; okra; peanut s; pecan s; 
peppermint; potato es; pumpkin s; squash, winter; sweet potato es; and water chestnut s.  
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 Da tabase (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. 
Moreo ver, where NHANES/WWEIA datasets provide the necessary data, we made additional  
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 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 m eals 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 int akes and 2 -day dietary intakes reported by survey respondents 
in the NHANES/WWEIA datasets.  
In addition, we added a third element to the set of criteria  we applied  to determ ine 
whether a commodity is rarely consumed raw. In the 2013 proposed rule, we appl ied 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 ana lysis 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 reg ularly consumed raw . This 
is reflected in the inclusion of raw kale in popular restaurant dishes  (Ref. 77) (Ref. 78)  (Ref. 79) ;  
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 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 conclusion s that commodit ies are  rarely consumed raw  are sufficiently 
reliable to justify removing  those commodities from the rule’s coverage , we concluded  that we 
should add a nother  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 represent ation 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 t his 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  × 0.01), whether its 1 -day consumption number “N” was 
equal  to or greater than 2,938,517 (293,851,741  × 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 consumpti on 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 repo rted consuming the commodity in any  
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 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  numer ical 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 tha t 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 fal l 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  
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 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 § 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).  
“Complete data” NHANES analysis:  
At least 1% of weighted number of 
respondents  consuming commodity in any 
form; less than 0.1% of population 
consumed uncooked ; AND  on less than 
0.1% of eating occasions , using either 1-
day or 2 -day survey  “No uncooked code ” 
NHANES analysis: At least 
1% of weighted number of 
respondents consuming 
commodity in any form; and 
no unco oked code reported in 
NHANES , using either 1 -day 
or 2-day survey  
 “Processed food” 
NHANES analysis: At 
least 1% of weighted 
number of respondents 
consuming commodity in 
any form; and r eported 
consumed only in 
processed food form with 
cook step  using either  1-
day or 2 -day survey  
Asparagus  Beans, black  Coffee beans  
Beans, lima  Beans, great Northern  Cocoa beans  
Beets, garden (roots and tops)  Beans, kidney   
Beets, sugar  Beans, navy   
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 § 112.2(a)(1)  
(All Analyses Combined, Alphabetical by Commodity)  
Proposed  Final   
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 Arrowhead1; Arrowroot1; Artichokes1; Asparagus; 
Beets; Black -eyed peas1; Brussels sprouts1; Bok choy1; 
Chick -peas; Collards; Crabapples1; Cranberries; 
Eggplant; Figs; Ginger root; Kale1; Kidney beans; 
Lentils; Lima beans; Okra; Parsnips1; Peanuts; Pinto 
beans; Plantains1; Potatoes; Pumpkin; Rhubarb1; 
Rutabaga1; Sugarbeet; Sweet corn; Sweet potatoes; 
Taro1; Turnips1; Water chestnut; Winter squash; Yams1  Asparagus; Bean s, black2; Bean s, great Northern2; 
Bean s, kidney; Bean s, lima; Bean s, navy2; Bean s, pint o; 
Beets, garden (roots and tops); Beet s, sugar; Cashew s2; 
Cherr ies, sour2; Chickpea s; Cocoa beans2; Coffee 
beans2; Collards; Corn, sweet; Cranberr ies; Date s2; Dill 
(seed s and weed)2; Eggplant s; Fig s; Ginger; Hazelnut s2; 
Horseradish2; Lentil s; Okra; Peanut s; Pecan s2; 
Peppermint2; Potato es; Pumpkin s; Squash, winter; Sweet 
potato es; Water chestnut s 
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 § 112.2(a)(1) to final § 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 Chickpea s 
Ginger root  Ginger  
Kidney beans  Bean s, kidney  
Lima beans  Bean s, lima  
Pinto beans  Bean s, pinto  
Sugarbeet  Beets, sugar  
Sweet corn  Corn, sweet  
Winter squash  Squash, winter  
 
 
We acknowledge there are certain limitations to th is 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 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 l ags behind changes in consumption. While the data source we have  
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 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 commod ity 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 
produc e 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 w e 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 survey s 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 thes e 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  
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 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 -representativ e 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 § 112.2(a)(1). One comment states that their 
interpretation of “raw” extends beyond cooking at the consumer level, and that although both 
consum er-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 comment s suggest that commodities treated with propylene oxide (PPO) to reduce 
levels of Salmonella  and other vegetative pathogens should be exempt as rarely consumed raw.  
135 
 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 § 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”, ther efore, 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 rar ely consumed raw produce (in § 112.2(a)(1)) is separate 
and distinct from the eligibility for exemption provided for produce that receives commercial 
processing (in § 112.2(b)). Produce commodities exempt under § 112.2(a)(1) are almost always 
eaten only af ter 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 con sumed 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 § 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 reduce s 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 ,  
136 
 L. monocyt ogenes , and E. coli O157:H7). Tomatoes  are eligible for exemption under § 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 § 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 § 112.2(b) if all relevant conditions are met, including that the treatment adequately 
reduce s the presence of microorganisms of public health significance.   
We recognize, however, that a produce commod ity that is generally exempt from this 
part because it is rarely consumed raw may, in some cases, also receive commercial processing 
that adequately reduce s the presence of microorganisms of public health significance. However, 
because such commodity is al ready exempt under § 112.2(a)(1), we would not consider the 
commodity under the provision in § 112.2(b)(1) or expect the farm to take the steps required 
under § 112.2(b)(2).  
 
4. Produce That is Eligible for Exemption Based on Receipt of Commercial Processing That 
Adequately Reduce s Pathogens (§ 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, R oma, or plum tomatoes is a 
common practice. This comment states that there are numerous instances where tomatoes grown  
137 
 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 
§ 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 § 112.2(b) applies to produce that receives commercial 
processing that adequately reduce s the presence of pathogens. Thus, the exemption is only 
available to produce that is actually processed in a manner that adequately reduce s 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 § 112.192, for which FDA may take appropriate 
action. Therefore, it is important that covered farms that rely on the exemption in § 112.2(b) 
ensure that the relevant produce meets the exemption criteria and take th e steps required in 
revised § 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, rathe r than a single “kill step,” adequately reduce s the presence 
of pathogens. We are adding as examples of commercial processing that adequately reduce s the 
presence of microorganisms of public health concern “otherwise manufacturing/processing 
produce into p roducts such as… wine, beer, or similar products.” Winemaking and brewing  
138 
 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 § 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 Mic robial 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 revi sed 
requirements are also consistent with similar requirements in §§ 117.136 and 117.137 of the 
PCHF  regulation, and in § 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  
139 
 hazards under certain circumstances.  
Under the first of the new provisions (§ 112.2(b)(2)), you must disclose in documents 
accompanying the produce that the food is not process ed to adequately reduce  the presence of 
microorga nisms 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, (§ 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 adequat ely reduce  the presence of 
microorganisms of public health significance (§ 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 (§ 112.2(b)(3)(ii)). In the lat ter case, the customer’s written assurance must also 
affirm that the customer will disclose in documents accompanying the food that the food is not 
process ed to adequately reduce  the presence of microorganisms of public health significance 
and that the cus tomer 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 process ed to adequately reduce  
microorganisms of public health significance. U nder § 112.2(b)(4), we are requiring you to 
keep documentation of the disclosures required under § 112.2(b)(2), and the annual written 
assurances obtained from customers required under § 112.2(b)(3). This replaces the 
requirement in the 2013 proposed rule that you keep documentation of the identity of the  
140 
 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 requirem ent in § 112.2(b)(5) (proposed as § 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 written assurances 
described in § 112.2(b)(3), we are specifying in § 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 § 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, complyi ng with, and documenting compliance 
with the written assurances described in § 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 tha t the food is not process ed 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 § 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 § 11 2.2(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  °F to 180  °F for one o r  
141 
 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 reduce s the presence of pathogens is eligible for exemption under § 112.2(b) if all 
of the conditions in that section are met. Blanching and/or freezing processes may qualify if 
they are valida ted 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 §§ 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 consumpt ion 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, specifical ly, 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 p roduce 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.   
142 
 (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 § 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 cho y 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 commodit y in 
any form . Therefore, we are removing bok choy from the list of rarely consumed raw prod uce 
in § 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 a re rarely consumed raw on the lack of an uncooked code reported in the 1999 -2006 
NHANES/WWEIA dataset. ( We note that we  incorrect ly described our  categorization of this 
commodity in the 2013 proposed rule  in a way that did not affect the ultimate result, but  did  
143 
 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 consu med 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 § 112 .2(a)(1). Instead, Brussels sprou ts 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 weighte d 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 fo r 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 § 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  
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 in § 112.2(a)( 1) and, instead, are covered produce subject to 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) , turnip s, 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 appropriat e to analyze 
consumption collectively to account for the entire harvested or harvestable portion of the plant. 
Based on o ur 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 
§ 112.2(a)(1) specif y “root and tops”  and “seeds and weed”, respectively . Conversely, dashe en 
(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, dashe en (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  
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 “turnip ” from the list of rarely consumed raw produce in § 112.2(a)(1). Instead, both dasheen 
(corm and leaves) and turnip (roots and greens) are covered produce subject to the 
requirements o f part 112 as applicable.   
In addition, two other commodit ies (i.e., a rtichoke s and plantains) that we had proposed 
to exempt as rarely consumed raw produce  (based on previous ly available uncooked 
consumption data ) are now not on our final list in § 112.2(a)(1)  because less than 1  percent  
weighted number of survey respondents report consumption of these commodit ies in any form  
and therefore  they do not meet our revised criteria for rarely consumed raw  (Ref. 73) . 
Artichoke is reported in the current NH ANES/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 meet s 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 i s no “uncooked” consumption category reported. Several comments argue that kale, which  
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 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 par snips 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), p eppermint (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 le ss 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 consum ers 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 commodit y 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 consumptio n in the  
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 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, c ashews, 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 § 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 p eppermint are rarely consumed raw  and, 
therefore,  we include them in the list in § 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 un der § 112.2(a)(1), we 
note that the FD&C Act still applies to the production of hazelnuts. )  
In addition, five other commodit ies 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 § 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  
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 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 § 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 c onsumption 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  quan titative  
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 § 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  
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 of the process of being made into the identified pr ocessed 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 co nsumed raw produce in § 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 proce ss 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 uncooke d 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 § 112.2(b)(1), provided the covered 
farm establishes and maintains documentation in accordance with § 112.2(b)(2). Brewing beer 
adequately reduce s 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 § 112.2(b)(1).  
 
(Comment 71) Some comments request exempting the following commodi ties 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,  
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 ramp, tamarillo, ti plant, and ulluko (melloco).  We also r eceived 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 pro vide 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, neit her 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 ap plied for these 
commodities . Therefore, we are removing arrowhead and arrowroot from the list of rarely 
consumed raw produce in § 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 rele vant data for  
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 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 i s 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 awa re 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. 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,  
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 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 w ine, to argue that wine grapes should be exempt from the standards established under 
this rule under proposed § 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 w ine 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”  
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 are not rarely consumed raw, and we do not include them in § 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 § 112.2(b)(1), prov ided the covered farm 
takes the required steps  in accordance with § 112.2(b). Winemaking adequately reduce s 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 § 112.2(b)(1).   
 
B. Definitions Other Than Small Business, Very Small Business, and Produce (§ 112.3(c))  
In the 2013 proposed rule, under proposed § 112.3(c), we propose d 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 “covere d activity,” “farm,” “harvesting,” “holding,” and 
“packing” in proposed § 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 thi s 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  
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 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 § 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 relate d 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 propo sed 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 §§ 1.227 and 117.We are adopting the same 
definitions of farm, manufacturing/processing, harvesting, holding, and packing established in § 
1.227 for purposes of the PCHF  regulation, now in § 112.3(c) for purpos es 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 § 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  
155 
 standards of pro posed 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, pr ovided 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 t hat:  
All food used in such activities is consumed on that farm or another farm under 
the same ownership; or  
Any manufacturing/processing of food that is not consumed on that farm or 
another farm under the same ownership consists only of:  
o Drying/de hydrating RACs to create a distinct commodity, and packaging and 
labeling such commodities, without additional manufacturing/processing; and  
o Packaging and labeling RACs, when these activities do not involve additional 
manufacturing/processing.  
Even aft er the revisions we proposed in the supplemental notice and the supplemental 
human p reventive controls notice, some comments asserted that the overall “farm” definition still 
presented an unrealistic and incomplete understanding of how most farms in the Un ited 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  
156 
 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 § 1.227, as explained in section IV of 
the final human preventi ve 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.  
Cons istent with the definition of “farm” in § 1.227, we are defining “farm” in § 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 mana gement 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 proce ssed 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, witho ut additional  
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 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 r aw 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 i s 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 ra w 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 fa rm 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.   
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 (Response)  There are two relevant considerations in the re vised “farm” definition. First, 
in the revised “farm” definition established in § 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 ownershi p” 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 farm s, food aggregators, and food hubs) 
and use language that the mo dern 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 o f 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 loc ation using the same practices 
even though there is no difference in risk. Some comments suggest adding a new paragraph to § 
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 h arvesting 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.   
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 (Response)  Under the revise d definition of “farm” we established in § 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 RAC s 
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 adoptin g this definition of farm in 
§ 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.  
(Response)  Under the revised defini tion of “farm” we established in § 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 § 112.3(c). Because, in this 
circumstance, the fa rm 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 § 112.4(a), providing 
that covered farms subject to part 112 must comply with all applicable requirements whe n 
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 t hat 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 § 112.4(a)) or may be eligible for a qualified exemption (see § 112.5) based  
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 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 
busine ss 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 argu es 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  
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 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 f all 
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 fo r 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 FS MA mandates 
that FDA conduct a rulemaking on additional recor dkeeping 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 § 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 achiev e compliance to the extent practicable. For example, 
this rule allows for sharing water testing data under certain circumstances  (see § 112.47(a)) . In 
addition, farms may find it useful to share training materials or record templates. We are aware 
of certa in 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) .  
  
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 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 § 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 § 1.227, w e are defining 
“manufacturing/processing” in § 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 activ ities 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, extr acting 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 “harve sting” in the 2013 proposed rule and consistent  
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 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 § 112.3(c).  
We proposed to amend the original ly 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 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 definitio n of “harvesting” 
and have established the revised definition in § 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 a nd revisions to our proposed definition of 
“harvesting”.  
Consistent with the definition of “harvesting” in § 1.227, we are defining “harvesting” in 
§ 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  
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 activities performed on raw agricultural commodities , or on processed foods cr eated 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). Exa mples 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 c omments 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 § 1.227, which we are adopting in § 
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 § 112.3(c).  
We proposed to amend the definition of “holding” to mean “storage of food and also 
includes acti vities 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  
165 
 distribution of that food (such as blending of the same [RACs ] and breakin g 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 facil ities, 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 § 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 § 1. 227, we are defining “holding” in § 
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 c ommodity 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.”  
  
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 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 o f “packing” in proposed § 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 th e 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 pr eventive 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 “pa cking” and have established the revised 
definition in § 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 § 1.227, we are defining “packing” in § 
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  
167 
 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 Fo od, 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 n ot introduce new or different risks to public health.  
 (Response)  We agree that packaging and labeling activities may include repackaging and 
relabeling and do not 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,” 
“man ure,” “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, exc ept as described in Table 
4. 
  
 Definition s 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 hea lth practice. We also proposed to define  
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 “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 d efinitions 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 exam ple, 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 hav e 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 “a dequately 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 s afety 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 reduce s 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  
169 
 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 “ adequatel y 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 § 112.2(b), the exemption 
for produce that receives  commercial processing that adequately reduce s 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 circumstance s, we cannot categorically conclude that they would do so under 
all circumstances.  
 
Definition s 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 agricu ltural tea to increase microbial biomass.  
  
170 
 (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 s imilar 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 
definitio ns 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  
171 
 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 . 
 
Definition s of “biological soil amendment” and “biological soil 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 te a, 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 de finition of “biological soil 
amendment.” We discuss this change in additional detail under the definition of “stabilized 
compost”.    
172 
  
(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 ‘biologi cal 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 coul d 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 s oil amendment should 
be considered “untreated.”  
(Response)  Section 112.51 establishes the requirements for determining a biological 
soil amendment as treated (§ 112.51(a)) or untreated (§ 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 § 112.51(b), a biological soil amendment is 
untreated if, among other conditions, the biological soil amendment has become contaminated 
after tre atment; has been recombined with an untreated biological soil amendment of animal  
173 
 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 illn ess. 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 humu s 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 ºF (55 ºC)), followed by a curing stage under coole r 
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 c ompost. For example, commenters point to mixing of 
organic waste with bulking agents, volatile organic compound s, heat, or water, and state that 
composting can occur under both thermophilic and mesophilic conditions, but is not always  
174 
 followed by curing. S ome comments suggest establishing performance standards rather than 
establishing a definition for composting.  
(Response)  We have revised §  112.54 to indicate that “composting” is only one type of 
biological process that may meet the requirements in that section and § 112.55(a) and (b) (see 
section XIV of this document). However, we also continue to believe that the process of 
composting invol ves 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 ar e 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 r evisions 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.”   
175 
 (Respo nse) 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 ha ve 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 def inition of “covered activity” to reflect new § 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 § 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 §§ 112.1 and 112.2. 
The term “covered produce” refers to the harvestable or harvested part of the c rop.  
 
(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 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 §§ 
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  
176 
 should be subject to part 112, it would not be appropriate to exempt some produce based on the 
point in time at which contami nation 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 § 112.2(a), we have exempted certain produce because it is 
rarely consumed raw, and in § 112.2(b), we have provided for produce to be eligible for 
exemption from the requirements of this rule if it receives commercial process ing that 
adequately reduce s 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 pro duce” 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 § 112.1 and not exempt from the rule under § 112.2. Not all 
“fresh produce” comm odities 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 
commo dities are not “covered produce” because they are exempt from this rule under the 
provisions of § 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  
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 composting, which is conducted after much of the readily metabolized biological material has 
been decomposed, at cool er 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 capture s 
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.   
178 
 (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 p ortion 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 dire ct 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 § 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 an imals, and articles used for components of any  
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 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 us ed 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 
harvesta ble 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 revision s 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” wit h “that has the potential to cause illness or injury” to more 
clearly distinguish “hazard” from “known or reasonably foreseeable hazard.” This increases the  
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 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 to include species 
having public health significance. W e 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).   
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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 acti vities 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 
requirem ent. 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 re gistered. 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 establish ment 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  
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 is governed by the exemptions established in § 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 f all 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 prev entive 
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 w ith “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,  
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 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.  
 
(Comme nt 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 p hrase “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 byp roduct. 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 (whe n 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 t he 
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  
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 used as a noun)” would apply when used in part 112, even though we did n ot 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 registratio n 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”)  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 consist ent 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”  
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 definition provides for packaging RA Cs 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 gr owing 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 small er 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  
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 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) Som e comments ask us to establish definitions for the terms “batch,” 
“sprouts,” and “soil -grown sprouts.”  
(Response)  We define “production batch of sprouts” in § 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, § 112.141, to clarify the types of commodities 
that are subject to the requirem ents 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 § 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 “Th e term ‘consumer’ does not 
include a business” from out of paragraph (ii) and into a parenthetical phrase  within the  
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 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 wit hin a S tate 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 R ico. 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 § 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 n ot 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 pro vide 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 purp ose 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  
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 themselves, do not amount to exemptions from the rule. A farm must meet all the criteria 
provided in § 112.5(a) to be eligible for the qualified exemption. These criteria in § 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 e stablishment 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 a s 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 
exemption, provided it meets the criteria establi shed in § 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 § 
1.227(b)(11), which is used in the definition of “qualified en d-user” in § 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 se parate 
rulemaking. In a recent n otice of proposed rulemaking titled, “Amendments to Registration of 
Food Facilities” (80 FR 19160; April 9, 2015) , FDA proposed various amendments, inc luding 
to the definition of “retail food establishment” in § 1.227(b)(11).  
  
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 (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 de finition of “qualified end -user” implements section 419(f)(4) of t he 
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, wi thout 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 § 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 incl uding the word “biological” within this proposed 
definition, consistent with the proposed definition of “hazard”.   
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 (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 t he 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 prov ided 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 purp oses 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 
undes irable 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 th at 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 m aking 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  
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 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 m ean 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 com menters 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 stabi lization 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 refer red 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  
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 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 “agri cultural 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 no t 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 compost can be made, which is not our intent.   
 
Definition of “static composting,”  We proposed to define “static c omposting” 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 me chanical means (such as blowers that suction air from the composting 
materials or blow air into the composting material using positive pressure).  
  
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 (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 defin ition 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 spo ts 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 § 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 c omposting” 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 mechani cal 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  
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 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 
horticultu re, 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 restrictiv e 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, a nd 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 pro vided 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  
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 “yard trimmings.” We use the term “yard trimmings” to a void 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 produ ce 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 r equirements 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 th e questions  
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 and provisions in §§ 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 docum ent; 
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 appropr iate, 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 Food CGMP regulation, 
especially where the routes of contamination are well -understo od 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 sanit ation). 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.  
  
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 (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 ined ible 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 th at 
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 th e 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 struct ure 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 term s 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 § 112.3 
is not necessary. We respond to comments about the applicability of subpart L to such  
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 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 th e 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 §  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 § 112.33(a) should in stead 
appear in § 112.3 with the other definitions, and we are making this change  to § 112.3 and 
eliminating proposed § 112.33(a) . 
  
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 (Comment 115) Some comments request definitions for other terms related to biological 
soil amendments, including for the ter ms “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 § 
112.3 is not necess ary.  
 
C. Small B usinesses, Very Small Businesses, and Farms That are N ot Covered or are Eligible for 
a Qualified Exemption  
In the 2013 proposed rule, under proposed § 112.3(b), we proposed to establish the 
definitions for very small business and small business, and under proposed § 112.4, we proposed 
to apply part 112 only to farms above a certain specified  average monetary va lue of sales (78 FR 
3504 at 3549). We also proposed  §§ 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 § 112.3(b)  as well as the 
provision in § 112.4 regarding farms not covered under  this rule (79 FR 58434 at 58436 -58438). 
In both the 2013 proposed rule a nd in the supplemental notice, we asked for public comment on 
our proposed provisions.  
We are finalizing §§ 112.4, 112.5, and 112.6 with changes, and adding new § 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 provision s in the supplemental 
notice.   
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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 t o 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 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  
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 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 f or 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 regulat ion.  
(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 veri fication 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, 
eligibl e for a qualified exemption , and/or eligible for an extended compliance period. Comm ents 
ask whether the value of produce donated to non -profit organizations such as food banks and  
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 senior centers would be counted towards sales. In addition, comments ask whether sales or 
donations to public institutions, such as prisons, would be counted t owards 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 instit utions 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 f or purposes of this rule.  
 
(Comment 120) Some comments seek clarification on the applicability of small or very 
small business definitions in proposed § 112.3 versus the eligibility criteria for a qualified 
exemption in § 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 compli ance periods (as small or very small business es) 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 fo od.”  
(Response)  We acknowledge that because of the difference in the bases for monetary cut -
offs established in § 112.3 and in § 112.5, there could be circumstances where a farm that is a 
small business or very small business (as defined in § 112.3) is al so eligible for a qualified 
exemption (in accordance with § 112.5). Farms eligible for a qualified exemption (in accordance 
with § 112.5) that also qualify as a small or very small business (as defined in § 112.3(b)), must  
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 comply with the modified requirem ents of §§ 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 pa rt 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 § 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 r ule. 
(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 A ctivities 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 RAC s harvested, packed, and/or held by the 
secondary activities farm owns, or jointly owns, a majority interest in the secondary activities 
farm . Thus, a f arm’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  
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 some farms may attempt to evade this regulation as suggested by the comment. How ever, 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 pr oduct 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 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. W e 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 activiti es associated with this 
rule. 
  
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 (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 (§ 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 th e effective date of this rule. In contrast, the $25,000 
monetary threshold in § 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  
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 inflation, an d we are revising § 112.4(a) accordingly. With respect to the monetary threshold 
related to eligibility for a qualified exemption, we are finalizing § 112.5, as proposed. Section 
112.5(a)(2) provides that the $500,000 figure will be adjusted for inflation,  and § 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 availab le 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 comment s, 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  
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 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 ac knowledge 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 o r 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 th eir  
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 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 § 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 § 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 ma ke 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 in the 
short term , both crop prices and exchange rates tend to stabil ize 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   
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 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” ver sus “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, compa red 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 di d 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 coveri ng 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 eligibl e 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  
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 to quantitatively determine the extent to which busine sses 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 tha t 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 expla ined 
elsewhere, the monetary threshold for a qualified exemption is established by statute as 
calculated based on all food, and we use this basis in § 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 (§ 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 § 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  
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 $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 harves ting of fruits and vegetables that are RAC s, 
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 bus inesses 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 
busin ess 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 U nited 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, appl ied 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 cove red 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  
212 
 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 bas ing 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 fi nalizing 
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.   
(Response)  We are providing extended complianc e 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 330 29 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  
213 
 Act to ensure the safety of their produce.  
 
4. The $25,000 Thresh old for Coverage Under the Rule (§ 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 
rangin g 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 s mall 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 regula te 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 threshol d 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  
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 the volume of produce in the marketp lace 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 appl icable 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 tha t 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 c oncluded 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 a pplying 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, an d 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 c overed produce, as explained in Comment 128 .  
We also considered alternative monetary value thresholds suggested by commenters.  
215 
 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, a pplied 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 (§§ 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 §§ 112.5 and 112.6 
reflect the fact tha t 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 dire ct 
farm marketing, as mandated by section 419(f)(1) of the FD&C Act. Similarly, § 112.6  
216 
 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 th ese 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.  
 
6. Criteria for Eligibility for a Qualified Exemption  (§ 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 wit hin 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 f or eligibility for a qualified exemption from 
$500,000 to a minimum of $1,000,000. This commenter states that the $500,000 limit in § 
112.5(a) would not adequately protect smaller farms, particularly because it would be applied to 
all food sales. In this r egard, 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 § 112.5(a), including the  
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 requirements related t o 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 § 112.3(c) implements 
section 419(f)(4) of the FD&C Act. Because these provisions are mandated by the statute, FD A 
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 cha nging 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 
throug h 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 § 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 201 3 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 § 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 sa les 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  
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 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 S tate 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 o f 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 “con sumer” 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 i s 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 o nly 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 ru lemaking. This 
rulemaking includes topics related to various types of sales platforms and the definition of “retail 
food establishment.”   
 
7. Applicable Requirements for Qualified Exemption  (§§ 112.6 and 112.7)  
(Comment 135) One comment requests that we clarify the cross -references in § 112.6(a) 
regarding the subparts applicable to farms eligible for the qualified exemption.   
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 (Response)  We are amending § 112.6(a) to provide the requested clarification, 
separating applicable subparts and including their tit les.  
 
(Comment 136) Some comments ask whether the required content of the label and point 
of purchase display requirements in § 112.6(b) includes only the name and address of the farm, 
or whether the notification must also include a statement notifying co nsumers of the farm’s 
qualified exemption from the produce safety regulation .  
(Response)  Label and point of purchase displays required under § 112.6(b) must include 
the name and the complete business address of the farm where the produce was grown. You ar e 
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 § 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 dis played under § 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 § 
112.6(b) is the farm where the produce was grown tha t 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 t his requirement. We are finalizing the requirement as 
proposed. If needed, we will consider issuing guidance in the future with respect to the  
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 application of this requirement when produce from different farms has been commingled.  
 
(Comment 138) Some commen ters 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 FDA consider 
alternativ e 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, website, 
email address, or business a ddress.  
(Response)  Section s 112.6 and 112.7 establish the modified requirements applicable to 
farms that meet the criteria under § 112.5 for a qualified exemption. As explained in the 2013 
proposed rule, these requirements are derived from the provisions i n 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 re quired notifications when the farm qualifies for the 
exemption (under § 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 F D&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 complet e 
address already required under section 403(e)(1) of the FD&C Act and the “place of business” 
labeling regulation (§ 101.5(d)) to be adequate for notification to consumers for foods required to  
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 bear labels, there would have been no need to impose a new, m ore 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, website , 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 
additiona l 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 w hen a farm is 
eligible for a qualified exemption from this rule. Therefore, we are finalizing § 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  
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 conditions associated with the farm that are material to the safety o f 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. The refore, we are adding a new provision § 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 qual ified 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 § 112.7, we are requiring that, if you are eligible for a qualified 
exemption i n accordance with § 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 record s required under 
§ 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 (§ 112.7(a)). Under § 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 § 112.5. Such records may 
include receipts of your sales to different buyers; the location of any buyers that are restaurants  
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 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 § 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 § 112.5(a)(2)), you must review your sales annually to 
confirm your continued eligibility for the qualified exemption for th e upcoming year. Under § 
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 § 112.16 1(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 § 
112.161(a)(4) in the 2013 proposed rule, the signature of the individua l 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,  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  
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 O, records required under this provision must be available and accessible to FDA for review 
upon request within 24 hours (see § 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 t hat a farm maintains 
under § 112.7 to support its eligibility  for a qualified exemption in accordance with § 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 re cords as applicable) is the effective date of this rule, 
i.e., [ INSERT DATE 60 DAYS AFTER DATE OF PUBLICATION IN THE FEDERAL 
REGISTER ]. 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 the ir 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 exem ption 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 eval uate 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  
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 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.  
 
  
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 X. Subpart B – Comm ents 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 (§ 112.11) and to establish a framework for 
alternatives to certain requirements establishe d in this part that would be permitted, under 
specified conditions (§ 112.12). We asked for comment on all provisions in subpart B.  
We are finalizing these provis ions 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  
§ 112.12  - Revision to refer to new § 112.49, which lists all 
of the requirements in subpart E for which we 
allow the use of alternatives  
- Revision to eliminate proposed § 112.12(a)(2), 
consistent with revisions to proposed § 112.54  
- Revision to replace “listed in” in proposed § 
112.12(b) and (c) with “specified in” to reflect 
new reference to § 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 § 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  § 112.11  
(Comment 140) One comment states that the definition and application of the term 
“reasonably” is unclear in § 112 .11, and expresses concern about disagreements between farmers 
and FDA over what measures are re asonably necessary to prevent the introduction of known or 
reasonably foreseeable hazards and provide reasonable assurances that the produce is not 
adulterated.  
 (Response)  In § 112.3, we revised our proposed term “reasonably foreseeable hazard” 
and corresponding definition to now use “known or reasonably foreseeable hazard” to mean a  
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 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 establi shing 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 pro duce. 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 th e 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 s afety of agricultural water, biological soil amendment s 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 § 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 know n or reasonably foreseeable 
hazards into covered produce, and to provide reasonable assurances that the produce is not  
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 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, § 112.11 accounts for the variety of possible 
circumstances that might arise in which unique farm circumstances 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 haz ards.  
 
B. General Comments About Alternatives in § 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 co nsider 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 § 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  
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 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 operation s, in light 
of conditions, processe s, 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 rang e 
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 ba sis 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 circumstan ces 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 § 112.12. See 
also comments under section IV.F of this document. For example, o ne 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 § 112.12(c), for any alternative that you use under the 
provisions of § 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 t hird party. Such  
230 
 scientific support may be derived from or include commodity -specific or other guida nce 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 § 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 r elated to agricultural water, which are listed in § 112. 49 and cross -
referenced in § 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 §  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, su ch requests must be submitted by a 
State , tribe, or foreign government to FDA using the citizen petition process in § 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, § 112.12, with the provisions  
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 allowing States , tribes, and foreign governments to request variances from one  or more 
requirements of the rule in subpart P, §§ 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 th is rule. See our discussion of the variance provisions and 
entities eli gible 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 § 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 § 112.44(a) for certain uses of agricultural 
water and proposed § 112.55 for soil amendment treatment processes), and water testing 
frequency ( proposed § 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 app roach 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 s imilar to those contained in the Food CGMP regulation , especially where 
the routes of contamination are well -understood and appropriate measures are well -established 
and generally applicable across covered produce commodities ( e.g., personnel qualifications,  
232 
 training, health, and hygiene; harvesting, packing, and holding activ ities; 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 approp riate 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 st andard that specifies the appropriate measures for each possible circumstance ( e.g., 
requirements for assessment related to animal intrusion in § 112.83 and inspection of 
agricultural water system in § 112.42). We are not convinced by comments suggesting t hat 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, f or 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 spro ut 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  
233 
 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 th e 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 g roup 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 effect iveness 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 
provi sions 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 §§ 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 fo r the use of  
234 
 scientifically -supported alternatives to the se 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 § 112.56(a)(1)(i)) and compost ( proposed § 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 §§ 112.56(a)(1)(i) and 112.5 6(a)(4)(i)) 
removing the application interval requirements, which makes the corresponding alternatives 
provisions unnecessary. We are finalizing § 112.56  with some changes, under which 
alternatives continue to be unnecessary (see section XIV.G of this docu ment) . 
For other provisions that include numerical criteria , i.e., §§ 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 co nditions 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 § 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 § 112. 54. We do not intend § 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 § 112. 54 must be validated. Farms would be able to use  
235 
 treatment processes that are validated to meet the relevant microbial standard in § 112.55 
without the need to test the end products of their treatments to confirm that the microbial 
standard was achieved. B ecause our revisions to § 112.54( a) already provide for the use of any 
scientifically valid, controlled treatment processes that are demonstrated to satisfy the 
microbial standard  in § 112.55(a) for L. monocytogenes , Salmonella  spp., and E. coli O157:H7 , 
further provision under § 112.12 for use of alternatives is not necessary. Similarly, because  in 
revised § 112.54( b) we already explicitly provide for the use of any scientifically valid, 
controlled treatment process  that is demonstrated to satisfy the micr obial standards in § 
112.55(b) for Salmonella  and for fecal coliforms  (see § 112.54(c)(3)), a  corresponding 
alternatives provision under § 112.12  is not needed. Given these revisions to  § 112.54  (see 
section XIV of this document), we have  eliminat ed proposed § 112.12(a)(3)  in finalizing § 
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 involve the submission of a 
citizen petition by a Stat e, 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 § 112.12. An allowance for alternatives to be establi shed 
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 § 112.12.  
 
D. Additional Clarification   
236 
 (Comment 146) A number of comments ask what is meant by the requirement in § 
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 § 112.12(a), you may establish an alternative to one or more of  
certain requirements established in subpart E, as specified in § 112.49. Because, for 
clarification, we have listed all of the requirements in subpart E for which we permit 
alternatives  within new  § 112.49, in § 112.12(a), we simply provide a cross -reference to § 
112.49 rather than listing out each of the specific requirements for which alternat ives are 
permitted (as we did under proposed § 112.12(a)). As a conforming edit, we are changing two 
occurrences of “listed in [§ 112.12(a)]” in § 112.12(b) and (c) to read “specified in [§ 
112.12(a)].” As specified in §  112.49, in accordance with § 112.12 , you may establish and use 
alternatives to the following specific requirements related to agricultural water: §§ 112.44( b), 
112.45(b)(1)(i), 112.4 6(b)(1)(i)(A), and 112.4 6(b)(2)(i) (A).  
Section s 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 applicat ion method.  
The § 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 ca lculation 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  
237 
 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 criteri on (or criteri a). Under § 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 § 112.44( b). We 
recommend that the scientific data or in formation to support the use of an alternative indicato r 
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 § 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 adult erated. In addition, for any use of an alternative indicator, you should also 
consider whether the microbial die -off rate that we established in § 112.4 5(b)(1)(i), if you choose  
238 
 to apply it in conjunction with your alternative microbial quality criteria , continues to be 
appropriate.  
Similarly, under § 112.4 9(b), you may establish an alternative to the microbial die -off 
rate between last irrigation and harvest and accompanying maximum time interval  established in 
§ 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 § 
112.4 5(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 mic robes 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 es timate 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 § 
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 accompa nying 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  
239 
 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 -
establish ed standard and ensuring that your alternative standard would not increase the likelihood 
that your covered produce will be adulterated.  
In § 112. 49(c) and (d),  we are provid ing for the use of alternative water testing 
frequency in lieu of the FDA -established required number of samples for the initial survey 
(established in § 112.4 6(b)(1)(i) (A)) and the annual survey (established in § 112.4 6(b)(2)(i) (A)) 
for the testing of untrea ted 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 § 
112.45(b)), which we are retaining with some changes  (final § 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 tes ting. Among the testing requirements in § 
112.4 6(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  
240 
 deviation of log 10 E. coli abundance measurements in surface waters is 0.4  (Ref. 100) . We 
acknowledge that circumstances unique to the variability of the microbial qualit y 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 
log 10 E. coli abundance measurements for their surface w ater 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 § 112.4 6(b)(1)(i) (A) or 112.4 6(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 § 112.4 6(b)(1)(i) (A) and 112.4 6(b)(2)(i) (A), and does not extend to the other required 
elements of testing, specified in § 112.4 6(b). Likewise, we are not providing for an alternative 
to the testing frequency specified in § 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 § 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 .  
241 
 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 o n water quality.  In 
light of the specific provisions for which we are allowing alternatives in this rule, we are 
deleting two phrases from proposed § 112.12 as unnecessary: “including meeting the same 
microbiological standards, where applicable,” and “incl uding 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 throu gh 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 produ ce after exposure from contaminated surface irrigation water,  
242 
 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 
pathog ens 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 f armers 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 § 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 ind ustry or trade associations and commodity boards. 
You may establish the alternatives under § 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, p ractices, and conditions, in accordance with § 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,  
243 
 conditions, or practices. However, such generalizations may not a lways be appropriate. 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 scientifi c information to their operations, as appropriate.  
 
E. Prior A pproval 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 § 112.12 to specifical ly 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 § 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 comp liance with the provisions of 
§ 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 § 112.12(c), and make such data and information available to us 
to evaluate upon request, under § 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 inform ation, as well as conducting significant education and outreach related  
244 
 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.   
245 
 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 p roduce, 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 ar e finalizing these provisions with revisions (see Table 9). We discuss these changes 
in this section. For § 112.23, we did not receive any comments or received only general 
comments in support of the proposed provision and, therefore, we do not specificall y discuss this 
provision.  
Table 9.-- Description of Revisions to Subpart C  
Final Provision  Description of Revisions  
§ 112.21(a)  - Revision such that required training must be 
repeated periodically thereafter , at least once 
annually  
§ 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  
§ 112.22  - Revision to change “should” to “must” in § 
112.22(b)(1)  
§ 112.30  - No change  
 
A. General Comments   
246 
 (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 tran smitted 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 tr aining 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 gree n 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 
ensurin g 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  
247 
 requirements based on the size of the business. Training farm workers is important regardless of 
the size of the farm.  
 
(Comment 151) Tw o 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 particul arly useful for workers 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 t o 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 shoul d 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.   
248 
 (Response)  We see the value of workers r eceiving 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 § 
112.30 (b)(1) , you must establish and keep records of training that document required training of 
person nel, 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 cor responding training 
materials.  
 
(Comment 153) Some comments urge the use of website(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 rapi d 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 onli ne.  
 
(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  
249 
 (including manufacturers, exporters, and regulators) can understand and p roperly 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 document s 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 techni cal 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 government s as well 
as training of foreign industry entities.  
 
B. Qualification and Training for Personnel Who Handle ( Contact) Covered Produce or Food-
Contact Surfaces (§ 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 othe r 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 work ers, 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  
250 
 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 traini ng 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 fr om 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 § 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 (§ 
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 (§ 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 ref resher 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 lie u of the proposed 
requirement to train workers at the beginning of each growing season if applicable, we are  
251 
 revising the requirement to specify  that periodic training must be conducted at least once 
annually. This requirement is in addition to the trainin g 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 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. I n 
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 di sagree with the 
suggestion that education or experience can serve as a substitute for appropriate training.  
  
252 
 (Comment 157) Some comments seek clarification on whether “pick -your-own” farms 
would be required to provide training to customers who pick their o wn 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 re quires, in § 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 polici es 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 ar e establishing it in this rule (see definition of  
253 
 “farm” in § 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 th ose 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 continu es 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 cond uct 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 c hoose to 
rely on the harvest crew company to provide or conduct the training, request relevant  
254 
 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 ru le (see definition of 
“farm” in § 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 § 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 definit ion, 
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  
255 
 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 cou ld 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.  
 
C. Training Personnel Who Conduct a Covered Activity (§ 112.22)  
We are revising § 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 § 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 effi cient  
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 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, rathe r 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 ot her 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 § 
112.22(c)). We expect this s tandardized 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 § 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 § 
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 § 112.22(a) and, as applicable, § 112.22(b). We encourage 
trainers outside the PSA and SSA to  evaluate their courses against the PSA and SSA materials  
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 when they become available and to modify or adapt curricula, where necessary, to ensure that 
they are consistent with, and provide at least an equivalent level of instruction to, the Alliance 
course s. 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 t raining 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 t o 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 A dministration” as stated in § 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, altho ugh 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 th e elements of “food hygiene and food safety” that should be covered in 
comprehensive training, and offers suggestions on such elements.   
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 (Response)  FDA concludes that the broad topic areas addressed in § 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 (§ 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 § 
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 § 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 .  
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 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 t hose 
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 p roposed 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.  
Table 10.-- Description of Revisions to Subpart D  
Final Provision  Description of Revisions  
§ 112.31  - Fixed grammatical error in § 112.31(a) (deleted 
“a” before “communicable illnesses”)  
§ 112.32(b)  - Update d list of examples of hand drying devices 
in § 112.32(b)(3)  (deleted “clean cloth towels” 
and added “electric hand dryers”)  
- Revision to § 112.32(b)(3) to allow the use of 
“other effective  surfactants ” in lieu of soap during 
hand -washing  
- Added n ew § 112.32(b)(5) to require removing or 
covering hand jewelry under certain 
circumstances  
- Added n ew § 112.32(b)(6) to prohibit eating, 
chewing gum , and using tobacco products in areas 
used for c overed activities (except that drinking 
beverages is permitted in designated areas)  
§ 112.33  - Deleted proposed § 112.33(a) defining “visitor” 
(moved  definition of visitor to § 112.3(c) ) 
 
A. General Comments   
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 (Comment 165) We received several comments  on this subpart , many of which support 
the proposed provisions under subpart D. Many c ommenters 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 foreseeab le 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 recog nized 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.   
(Respons e) 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 int o 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 f or 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 a ll firms to use 
appropriate hygienic practices in the production of produce, regardless of whether they are 
subject to this rule. Under § 112.2(b) covered produce that receives commercial processing that 
adequately reduce s 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  
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 (i.e., it is typically cooked before consumption) is not subject to this rule under § 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 m icroorganisms 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 r equirement 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 (§ 112.31)  
(Comment 167) Some c omments seek clarification on compliance with this provision and 
express concerns about the feasibility of continuously monitoring workers for signs of illness.  
Some c omments 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 illn esses that present a 
public health risk in the context of normal work duties, infection, open lesion, vomiting, or 
diarrhea) (§ 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  
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 from working in any operations that may result in contamination of covered produce or food -
contact surfaces with microorganisms of public health significance w hen 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 pre sents a risk to public health (§ 
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 visi tors, 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 (§ 112.22(a)(2)).  
Another measure we require is t hat 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 (§ 112.31(b)(2)). Consistent with the training 
requirement in § 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 § 112.31(b)(1), when or how often workers’ health must  
be considered , we expect covered  farm s 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 inquir e about the health of the harvest crew daily when they report to 
work, prior to allowing the crew to enter the fie ld to begin harvesting, and mak e appropriate 
decisions about whether any workers should be reassigned to different duties.   
263 
 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 em ployee 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 fo r 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 (§ 112 .32) 
(Comment 168) Some comments raise concern with the provision that would require 
washing hands after certain specified occasions. Some c omments 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  
264 
 hand -washing  before handling produce and throughout handl ing, as needed, taking into account 
the presence of debris or other unsanitary conditions. Another comment incorrectly interprets 
proposed § 112.3 2(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) require s (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 requir ing hands to be sterile and free of microorganis ms. 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 re quiring 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 ani mals) 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  
265 
 wash their hands. In addition, under § 112.32(b)(2), whic h 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 § 112.130(b)(3), we are making a revision to 
the examples of hand drying devices in § 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 §  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 § 
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 reusab le gloves for different activities, and that whereas disposable gloves  
266 
 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 § 112.32(b)(4), if gloves 
are used in handling covered produce or food-contact  surfaces, you are required to maintain the 
gloves eithe r 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 § 112.3 2(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 exam ple, 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 je welry, gum, spitting, chewing, eating, and drinking 
(excluding drinking water) in growing areas.  
(Response)  We are revising § 112.32(b) to add two new provisions. New § 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 addresses th e 
potential biological hazard posed by jewelry that is not effectively cleaned and could serve as a  
267 
 harborage for pathogens. New § 112.32(b)(6) requires not eating, chewing gum, or using tobacco 
products in an area used for a covered activity (however, dri nking beverages is permitted in 
designated areas). Eating, chewing gum (and potentially spitting the gum out), and using tobacco 
products (and potentially dropping used cigarette s or cigar s or spitting chewing tobacco juice) all 
constitute potential avenues of dissemination of enteric foodborne pathogens  (Ref. 103) (Ref. 
104) (Ref. 105) (Ref. 106) . However, w e are not prohibiting the consumption of beverages by 
personnel in designated areas . For example, d rinking 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 requirement s are consistent with , although not identical to,  the requirements for 
food facilities, under the PCHF regulation (§ 117.10(b)(4) and (b)(8)), and our long-standing 
provisions in the Food CGMP regulation (§ 110.10(b)(4) and (b)(8)).  
In addition , these  requirement s 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 pe rmitted 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 an other  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  
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 have a written policy regarding jewelry. We believe many farms are already implementing the 
measures required by § 112.32(b)(5) and (6) based on these industry recommendations , and we 
believe they are practica l 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 (§ 112.33)  
(Comment 172) One comment questions whether or how proposed § 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 activ ities 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 cover ed 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  
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 measures that reasonably minimize the potential for visitors to become a source of produce 
contamination , provide reasonab le 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 § 112.3(c) using the text in proposed § 112.33(a). As a result, we have 
elimi nated proposed § 112.33(a) , and we are renumbering proposed § 112.33(b) and (c) as final 
§ 112.33(a) and (b), respectively.  
Under final § 112.33( a), you must make visitors aware of your policies and procedures 
to protect covered produce and food -contact su rfaces 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 § 112.33( a) by explaining the importance of health and 
personal hygiene, in cluding 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 § 112.33( a).  
We believe that the requirements of § 112.33 are those reasonably necessary to prevent 
contamination of covered produce by  visitors. As such, we decline to include requirements that  
270 
 apply directly to visitors.  
 
(Comment 173) Other comments express concern with proposed § 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. Anothe r 
comment requests that proposed § 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 an d well -maintained 
toilet and hand -washing  facilities for their personnel as a measure to prevent contamination of 
produce  and food -contact surfaces (see §§ 112.129 and 112.130), and § 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 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 f arm 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 §§ 112.1 29 and 112.130, respectively. As noted in the 2013 proposed rule, a farm could 
comply with the requirements of § 112.33 by, for example, indicating the location of restrooms  
271 
 and hand -washing  facilities that are accessible to visitors and clearly posting ru les 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 ris k 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 (§ 112.32), adequacy of toilet and hand -washing facilities (§ § 
112.129 and 112.130), and visitors (§ 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.  
  
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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 st andards 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 prop osed rule, we proposed to amend our water quality and testing 
requirements in proposed §§ 112.44 and 112.45 (79 FR 58434 at 584 40-58457).  
In the 2013 proposed rule and the supplemental notice, w e 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 system s, and pooling of water; the 
treatme nt 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 agricu ltural water used during 
harvest, packing, and holding activiti es 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 agric ultural water in the 2013 proposed rule, but that we did not address in the  
273 
 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 severa l changes . We re-structured subpart E to 
better organize the requirements related to agricultural water into the following categories : (1) 
General requirement s for agricultural water quality  (§ 112.41) ; (2) Inspection of agricultural 
water distribution systems and pooling of water  (§ 112.42) ; (3) Treatment of agricultural water  
(§ 112.43) ; (4) Specific microbial quality criteria for certain uses of agricultural water  (§ 
112.44) ; (5) Follow -up measures or corrective actions if agricultural water does not meet 
applicable requirements, including microbial quality  criteria  (§ 112.45) ; (6) Frequency of testing 
of agricultural water  (§ 112.46) ; (7) Who must p erform water tests and what analytical methods  
must be used  (§ 112.47) ; (8) Agricultural water that is u sed during harvesting, packing, and 
holding  (§ 112.48) ; (9) Permitted alternatives  (§ 112.49) ; and (10) Records requirements  (§ 
112.50) . In Table 11, we identify the new final provision corresponding to each proposed 
provision, and describe  the nature of s ubstantive revisions to that proposed provision. We discuss 
all of the revisions to the proposed requirements in this section.   
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 Table 11.-- Description of Re-arrangement and Revisions to Subpart E  
Proposed Provision  Final Provision  Description of Revisions  
§ 112.41  § 112.41  - No change  
§ 112.42(a), (b), (c)  § 112.42 (a), (b), (c)  - Revision to clarify inspection requirement in § 
112.42(a) applies to the extent agricultural water 
distribution system s 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 § 112.42(a) to clarify inspection is 
required at the beginning of a growing season, as 
appropriate, but at least once annually  
- Revision of § 112.42(a)(4) to make clear both 
adjacent and nearby lands are  to be  included in 
required  considerations  
- Reordered § 112.42(b) and (c)  
- Revision of § 112.42(b) to clarify maintenance 
requirement for agricultural water distribution 
systems applies to the extent such systems are  
under your control  
- Revision of § 112 .42(c) to clarify measures 
required to adequately maintain agricultural water 
sources  
§ 112.42(d)  § 112.45(a) and 112.45(b)  - Revisions to clarify measures that are required 
when agricultural water is not safe or of adequate 
sanitary quality for its inte nded use; does not meet 
the microbial quality criterion in § 112.44(a); or 
does not meet the microbial quality criteria in § 
122.44(b)  
- Revision to replace “the entire agricultural water 
system” with “the entire affected agricultural 
water system” to clar ify re -inspection requirement  
§ 112.42(e)  § 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  
§ 112.43(a) , (b), (c) § 112.43(a) and (b)  - Revision to clarify 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, i ncluding using a 
pesticide device, and other suitable method as 
additional treatment options  
§ 112.44(a)  § 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 § 112.44(a)  
- Revision to delete proposed § 112.44(a)(3) 
reference to water used to make agricultural teas   
275 
 § 112.47(b)  - Rearrangement of requirements to use specified 
analytical methods into a separate prov ision 
within § 112.47  
- Requirement that samples must be aseptically 
collected  
§ 112.44(b)  § 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 § 
112.44(a)  
§ 112.44(c)  § 112.44(b)  - Revision to separate testing requirements and 
required follow -up measures from microbial 
quality criteria  
§ 112.47(b)  - Rearrangement of requirements related to 
analytical methods as a separate provision within 
§ 112.47  
- Requirement that samples must be aseptically 
collected  
§ 112.44(c)(1), (c)(2), and 
(c)(3)  § 112.45(b)  - Revisions to clarify measures that are required 
when agricultural water does not meet the 
microbial quality criteria in § 112.44(b), including 
the timing when such measures must be taken  
- New limitation in § 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 § 
112.44(b)  
- Revision to provide that an alternative microbial 
die-off rate permitted under § 112.45(b)(1)(i)(B) 
may be accompanied by a maximum time 
interval, in accordance with § 112.49  
§ 112.44(d)  § 112.49  - Consolidation of all provisions that provide for 
the use of alternatives into new § 112.49, with 
additional provisions to permit alternatives to 
testing frequencies required under § 112.46(b)  
§ 112.45(a)  § 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  
§ 112.45(b)  and (c)  § 112.46(b)  - Revision to combine testing requirements for 
untreated surface water and untreated ground 
water used for purposes spe cified in § 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 su rface 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 - 
276 
 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  
- Revision s to clarify timing of sample col lection  
§ 112.45(c)  § 112.46(c)  - Revisions to separately state testing requirements 
for use of untreated ground water  for uses 
specified in § 112.44(a)  
§ 112.45(d)  § 112.44(a)  - Revision to prohibit the use of untreated surface 
water for the purposes specified in § 112.44(a)  
§ 112.45(e)  § 112.47 (a) - No substantive change  
§ 112.46  § 112.48  - No substantive change  
§ 112.50  § 112.50  - Revision to combine two proposed records 
requirements related to test results ( proposed § 
112.50(b)(2) and (5)) into one requirement (§  
112.50(b)(2))  
- Revisions corresponding to elimination of § 
112.161(b), requiring records of actions taken in 
accordance with § 112.45, and establishing 
specific  requirements for application of time 
intervals under § 112.45(b) (§ 112.50( b)(6))  
- Revisions to require records  of scientific data or 
information related to use of alternatives 
permitted under § 112.49  (§ 112.50(b)(8))  
- Addition of new § 112.50(b)(9) to require 
documentation of any analytical methods used in 
lieu of the prescribed method in § 112.151 (a) 
 
  
277 
  
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 standa rd(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 s hould 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 kno wn 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 p roduce production, which indicates that 
agricultural water is a potential route of contamination of produce during growing, harvesting,  
278 
 and on -farm postharvest activities and that use of poor agricultural practices could lead to 
contamination and illness e ven 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 impleme ntation 
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 re search and collaborated 
with other f ederal 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. Researc h 
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  
279 
 Washington , to conduct research on a variety of commodities including apples, citrus, and 
onions. We intend to disseminate useful scientific information obtained from these effort s, 
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 
inappropria te because the final objective is to prevent pathogen contamination. Therefore, the se 
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 c omments 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 pathoge ns 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 describ ed 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 the mselves.  
In the United States, bacterial indicators have a long history of being used to 
demonstrate the safety of drinking water and adequacy of its treatment. They have also been 
used to monitor the status of drinking water in distribution systems and d etermine if surface  
280 
 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 tes ting 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 su pport 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)  
281 
 pathogens may be present even if the E. coli thresh old 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 provid e 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 do es 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 § 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 reliabl e 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 wi th 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  
282 
 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 w ater 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 developme nt 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, a nd 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  
283 
 agricultural water in § 112.44(a) and ( b) relying on gener ic 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 § 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 § 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 § 112.44( b) (proposed as § 112.44(c)) . A potential example of s uch 
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 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 § 112.44( b). Farms may establish such alternative microbial criterion (or 
criteria) , provided that t he 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 § 112.44( b) and would not increase the likelihood that the 
covered produce will be adulterated.   
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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 c omments also ask us to clarify whether and how subpart E 
applies to water used d uring 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 do es 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 commoditi es 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 defin e 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  
285 
 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 de hydration of covered 
produce). Related to this definition is our definition of “dir ect 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 surfa ces during use of the water (§ 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 t he 
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 (§ 112.41)  and Corresponding Corrective 
Measures (§ 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 commen ts  
286 
 suggest modifying proposed § 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 wat er” (see section IX.B of this document) or 
the applicability of the requirement in § 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 § 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, th at 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. 
There fore, 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 rul e. Uses of such water 
that are outside the scope of “agricultural water” subject to the standards in this rule may  
287 
 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 th e 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 adul terated 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 b e met to ensure agricultural water is safe and of adequate sanitary quality in 
compliance with proposed § 112.41. Comments also ask how the microbial quality criteria in 
proposed § 112.44 should be interpreted in relation to the requirement in proposed § 112.41.  
(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 wat er. 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 gen eral requirement in § 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 qua lity applicable to all covered activities that involve the use of  
288 
 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 § 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 § 112.44(b) . Each of these microbial quality 
requirements has a differ ent purpose, as discussed in the par agraphs that follow .  
First, the microbial quality requirement of zero -detectable generic E. coli, in final § 
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 direct ly to covered produce  through 
direct or indirect ( via food -contact surfaces) contact with the water . In this regard, we con sider 
the agricultural water that does not meet the microbial quality requirement  in final § 112.44(a) 
also does not meet the general requirement of safe and of adequate sanitary quality in final § 
112.41. Therefore, in final § 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 § 112.44(a), which are the same corrective measures that are necessary when 
your agricultural water does not meet the general requirement in § 112.41.  
We n ote, however, that agricultural water that meets the microbial water quality  
289 
 criterion in § 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 20 13 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 §  112.44(a) demonstrates that the water is not 
safe or of adequate sanitary quali ty for those specified uses, the converse is not necessarily true. 
That is, agricultural water that meets § 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 c riteria of specified levels of GM and STV values of 
generic E. coli, in § 112.44(b), for agricultural water used in a direct application method during 
growing of produce (other than sprouts), like § 112.44(a), are intended to address the known or 
reasonabl y 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 determin ing 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 § 112.44(b)  to 
support your long-term strategy  for use of water sources, u nder final § 112.45(b), if your water 
does not meet the microbial quality criteria in § 112.44(b), we require you to take certain  
290 
 corrective measures as soon as practicable , and no later than the following year. Those 
corrective measures  provide additional mean s 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 test ing scheme (§ 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 § 112.45(b).  
The stringency of the applicable microbial  quality criteria  (and related flexibility) varies 
between  § 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 § 112.44 ((a) or (b)) does not automatically 
ensure that the requirement in § 112.41 is satisfied. See also examples  discuss ed 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 c omments 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 quali ty for its intended use as required 
by proposed § 112.41.  
(Response)  Under  final § 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  
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 quality for its intended use (including when water does not meet the microbial quality criterion  
in § 112.44(a) ) (see § 112.45(a)) or when agricultural water does not meet the microbial quality 
criteria in § 112.44 (b) (see § 112.45(b)) .  
Under § 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 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 § 112.44(a).  The covered farm may also treat the water in 
accordance with the requirements in § 112.43. Depending on the circums tances, 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 § 112.44(a) may be 
appropriate for use as irrigation water for pr oduce (other than sprouts) if it meets the criteria  in 
§ 112.44( b)). See examples under Comment 246 . 
Under § 112.45(b), s pecifically in relation to irrigation water and other water directly 
applied to covered produce other than sprouts during growing, we have  incorporate d flexibility 
by provid ing 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 th an four consecutive days  (§ 112.4 5(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, pro vided the farm has adequate supporting scientific data and information for the 
microbial die -off and/or removal rates (§ 112.4 5(b)(1)(ii) ). We also provide for the use of an  
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 alternative microbial die -off rate between last irrigation and harvest and an accompanying 
maximum time interval, in new § 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 § 112.4 5(b)(1) to reduce the likelih ood that a covered farm will need to alter the 
source of its irrigation water. In addition, when water subject to the § 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  (§ 112.45(b)(2)) . It would also be an option for the farm to treat agricultural 
water in accordance with §  112.43  (§ 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 § 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 § 
112.43 . Violation of this rule is a prohibit ed act that may subject a farm to enforcement or other 
appropriate action (see § 112.192).    
 
(Comment 182) Some  comment s 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 §§ 112.41 and  
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 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 § 112.44(a ). You must  
determine the appropriate use of agricultural water in light of the conditions and practices on 
your farm , and t aking into account the  general safe and of adequate sanitary quality standard in 
§ 112.41 as well as any specific microbial quality criteria relevant to your intended use(s)  of 
that agricultural water  in § 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 (§ 112.42)  
(Comment 183) Several comments express concern regarding the identification of 
conditions that are reasonably likely to introduce known or reasonably foreseeable haz ards into 
or onto covered produce or food -contact surfaces in proposed § 112.42(a). These comments state 
that it is unclear what specifically  should be considered to be r easonably foreseeable hazards in 
making such a determination.  
(Response)  In § 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 sectio n 419(c)(1)(A) 
of the FD&C Act and reflected in several requirements in part 112. Under final § 112.42(a), 
you are required to inspect all of your agricultural water system s to the extent they are  under 
your control (including water source s, water distribution system s, 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,  
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 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 ext ensive 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 wastew ater 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 ar e 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 a re 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 § 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  
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 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.  
(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 § 112.4 6(b)) provide you with historical knowledge of your water 
sources, their quality, and factors that may affect their quality. Inspection of the water source s 
and any equipment used to obtain the water from the  source ( e.g., well head, pumps, pipes) can 
ensure that the portion s 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 § 112.42(a)(2), we are req uiring 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 § 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 § 112.42(a)(5),  
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 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 ov er 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 § 112.41 that your agricultural water must be 
safe and of adequate sanitary quality for its intended use.   
We are also revising § 112.42(c) to clarify that adequate maintenance of your 
agricultural water sources includes regularly ins pecting 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, we ll 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 § 112.42 requires 
every  covered farm operator to conduct an inspection of their water system s 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 
frequenc ies and start -stop acceptance criteria based on the capacity of their system.   
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 (Response)  In the supplemental notice, which we issued subsequent to the submission 
of these comments, we proposed to provide tiered approaches for spe cific 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 e stablishing 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 § 112.49 (c) and (d) , for the use of an alternative testing frequency for untreated s urface 
water sources (in lieu of those required in § 112.4 6(b)(1)(i) (A) or § 112.4 6(b)(2)(i) (A)), under 
the conditions specified in § 112.12.   
 
(Comment 186) We received several comments that request clarification on the phrase in 
§ 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 monitor ing 
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 propos ed rule does not adequately or 
realistically account for such complexity.  
(Response)  The agricultural water system s referred to in § 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  
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 sources and the extent to which you can protect the water source or its distribution system, we 
incorporated into § 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 system s 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 tha t 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 assoc iated with your agricultural water system (s), and evaluating these factors 
as part of your inspection under § 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 a re 
revising “under your control” in § 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 in §§ 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  
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 circumstances, some comments suggest that the phrase “at the beginning of the growing season” 
in § 112.42(a) should be replaced with “as applicable or at least annually.”  
(Response)  We recognize that many cro ps 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 § 112.42(a) to require inspection of agricultural water system s “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 annu ally, 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 t he 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 intr oduce 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 o f their water source to contamination.  
 
(Comment 188) A comment suggests that the language of § 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 “adjace nt” and “nearby” have different meanings, and we 
intend to require you to consider both adjacent land and nearby land uses in identifying and  
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 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 locat ion. 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 l and. While you may have little or 
no control of other agricultural water user s’ 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 § 112.42(d)(1 ) or 
proposed § 112.42(d)(2), and whether or not the farm  is required to follow proposed § 
112.42(d)(2) if the requirements in proposed § 112.42(d)(1) are met.  In addition, one comment 
focusing on proposed § 112.42(d) states that although it may be feasibl e 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 hea lth 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.   
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 (Response)  See our response to Comment  181 and Table 11. We have now consolidated 
proposed § 112.42(d) and proposed § 112.44(b) into final § 112.45(a), which establishes the 
corrective measures that must be taken, an d the required timing, when agricultural water does 
not meet the general requirement in § 112.41  and/or when it does not meet  the microbial 
quality requirement in § 112.44(a)  for those specified purposes. In addition , in final § 
112.45(b), we specify the corrective measures that must be taken, and the required timing, 
when agricultural water does not meet  the mic robial quality criteria in § 112.44(b)  for the 
specified purpose .   
Specifically , § 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 irri gation, 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 reducti on for these intended uses. For these specified uses, we are retaining the 
requirement, in final § 112.4 5(a), for you to immediately discontinue the use of the water that 
does not meet the applicable microbial quality requirement until you take the necessa ry 
required measures in § 112.45(a)(1)  or (a)(2) .  
In addition, with respect to the microbial quality criteria in § 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 §§ 
112.45(b) (1) and 112.49, making it less likely that a farm will have to discontinue use of the  
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 water used for these purposes due to small fluctuations in water quality. In addition, under §  
112.45(b) (2) and (3) , farms also have similar options to those in § 112.45(a). Moreover, under 
§ 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 foll owing year. See examples 
discussed under Comment  246.  
With respect to thresholds suggested by one commenter, w e have also made revisions to 
the water testing requirements that eliminate the need to re -characterize the water quality 
profile for § 112.44(b)  uses in response to specific annual survey results that are over a 
particular “threshold” (final § 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 § 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 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.    
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 (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 tempo rary 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 re visions . 
In final § 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 wa ter, is unnecessary and would not provide sufficient flexibility for 
covered farms to implement measures as necessary and appropriate.  
 
(Comment 191) Regarding proposed § 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 § 112.42(c) to 
refer to agricultural water distribution systems to the extent they are under your control .   
  
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 (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 §§ 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 syst em 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 represent s 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 § 112.42(a) includes  each discrete water source if a 
farm has mor e than one water source, and must also include all relevant water distribution 
systems, facilities, and equipment. We are revising § 112.42(a) to reflect this by clarifying that 
you must inspect “all of your agr icultural water systems, to the  extent they a re under your 
control (including water sources, water distribution systems, facilities, and equipment).”  
When a re -inspection is conducted to satisfy § 112.45(a)(1) or (b)(2) after identification 
of a problem with agricultural water, such re -inspection ca n 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 § 
112.45(a)(1) and (b)(2) to specify tha t such requirements apply to the “entire affected  
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 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 § 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  § 112.42(d)(1) alone, disregarding other applicable provisions 
in subpart E of part 112 . Other provisions in subpart E establish the minimum sci ence-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 ( §§ 112.44 , 112.45 , and 112.46 ). See the discussio n in section XIII.G of this 
document.  
 
D. Treatment of Agricultural Water (§ 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 § 112.43. For example, one comment states that widespread use of 
antimicrobial p esticides on ground water  and surface water sources by farms across the country  
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 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 § 112.43 would encourage the use of pesticides to treat 
agricultural water because treating water may be the most viable opt ion for some farm s, 
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 § 112.43(a), as proposed, and 
affirm that treatment of water should be an option available to farm s who believe their water is 
contaminated, based upon their experience and risk assessment. I n contrast, other comments state 
that the use of chemical sanitizers to treat 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  
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 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 w ater in § 112.43, 
with some revisions as explained here.  
In § 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 § 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 §§ 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 t o 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 hav e 
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 an d 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 § 112.43  might have been read to suggest that  the 
treatment of water is always a r equired measure to ensure the safety of water for its intended  
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 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 § 112.43 to read as follows: 
“§ 112.43 What requirements apply to treating agricultural water?  (a) When agricultural water 
is treated in accordance with § 112.45 of this part : . . . . ” In addition, in final §§ 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 § 112.41 
and/or to satisfy the microbial quality criteria in §§ 112.44(a) and/or (b).  
We recognize that improper use, management, or disposa l 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 env ironment (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 regulati on 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 produ ce 
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 re gistration and use. The FIFRA provides for federal  
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 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 discu ss 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 comm ents 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, s uch 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 chl orine 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 orchardi sts, in  
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 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 cer tification 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).  
FDA ha s 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 cro pland  
(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 chlor ine 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  
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 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 requirement s 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, commen ts 
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 farm s 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 la ck of approved treatments, farm s may treat water with unapproved methods that could 
lead to environmental and public health concerns. Another commenter recommends eliminating 
proposed § 112.43(a) because no approved treatment products for this use currentl y exist.  
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 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 t o 
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 t hat 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 § 112.43.  
Other comments state that EPA -approved products for tre ating 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 ve getable 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 regis tered 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 § 112.43 with some modifications, as explained under 
Comment 194 . This provision applies to  agricultural water (as defined in § 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  
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 consistent with § 112.43.  
At th is 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 fo r 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 product s 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 h ouses. 
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 f or 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 § 112.44( b). 
We anticipate that the delayed compliance dates  for certain water quality provision s 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  
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 registration of pesticide products for treatment of agricultural wat er 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 website 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 suitabl e methods for treatment 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 suit able 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 § 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 §  
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 112.44, as applicable , as required under final  § 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 website  (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 website 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 website 
at: http://iaspub.epa.gov/apex/pestic ides/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 Elimin ation System (NPDES) permit, and that 
implementation of agricultural water treatment in compliance with § 112.43 would expose farms 
to liability under the Clean Water Act (CWA), including a potential citizen suit. The commenter 
also maintains that requirin g farms to treat surface irrigation water with antimicrobial pesticides 
could subject farms to liability un der the ESA or potential increased scrutiny regarding their 
effects on anadromous ( i.e., ascending rivers from the sea for breeding) species. The commenter  
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 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 potentia l 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 desc ribed 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 11 2. 
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 § 112.84 that 
explicitly states that part 112 does not authorize or require covered farms to take actions that 
would constitute the “taking” of threate ned 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 finalizi ng 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 infor mation.   
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(Comment 198) Several commenters discuss the interface between proposed § 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 farm s 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). Thi s 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 § 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 cov ered 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;  
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 EPA -register ed antimicrobial pesticide product; or other suitable method). 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 considere d 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 tr eatment 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 § 112.43. One commenter claims that proposed § 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 establ ished 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 th at FDA clarify which water treatments beyond 
chlorination are available to comply with proposed § 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 treat ment, which minimize the potential for environmental and public health  
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 impacts. Relatedly, another commenter contends that FDA should explicitly recommend 
methods of water treatment that do not involve chemicals. Although supporting the requirement 
in prop osed § 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 § 112.44 , § 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 § 112.44, as applicable . The 
required quality is dependent on the intended use of the agricultural water, with specific 
microbial quality criteria established in § 112.44(a) for certain specified uses; in § 112.44( b) for 
use during growing of produce (othe r than sprouts) using a direct application method; and in § 
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 § 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 pr ogram 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,  
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 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 § 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 verif ication that the treatment process, monitored in 
accordance with § 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 ana lysis 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 di scussing these 
issues further in the Produce Safety Regulation implementation guidance to be issued in the near 
term.  
 
(Comment 200) Several com ments focus on the treatment of harvest and postharvest  
water. For example, one comment requests clarification o n whether the proposed standard would 
require water for dump tanks to have an added disinfectant, whereas another commenter  
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 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 w ater 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) th at 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 § 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 § 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 , theref ore, applies to wash 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  
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 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 additio n 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 (§ 112.4 5(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 § 112.44(a), and options for taking action when water 
does not meet that standard in § 112.4 5(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 su bstances 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 availa ble at: 
http://www.fda.gov/Food/IngredientsPackagingLabeling/PackagingFCS/RegulatoryAuthorityA
ntimicrobialSubstances/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 § 112.43 would create a 
preference for the use of antimicrobial pesticides as an appropriate water treatment method; these  
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 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 t reatment 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 t o 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 § 112.44, as applicable , we are providing 
for the treatment of water using any effective treat ment 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 EI S 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 § 112.43(a) to include additional examples besides chemical 
treatment methods.  
  
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 (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 crop s, 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 ef fective, 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 
farme rs, 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 
compl iance 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 treati ng 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 § 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 tha t substances which are prohibited in organic production are described  
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 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 § 112.43. In addition, options other than treating 
agricultural water are also available under this r ule 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 All owed 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 fin al 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 water treatments, postharvest  options with 
and wit hout 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) .   
 
(Com ment 203) Some comments discuss the costs associated with treating water under 
proposed § 112.43. Comments assert that some irrigation districts, municipalities, and farms lack 
the necessary infrastructure or financial resources to build such infrastructure. An ad ditional  
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 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 Comm ent 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 ru le. Therefore, for covered activities involving covered 
produce (except sprouts) , we are providing extended compliance periods for certain wa ter 
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 cos ts 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 § 112.43 if such treatment would conflict with applicable laws . 
(Response)  There is nothing in § 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 agricultur al 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.   
  
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 E. Microbial Quality Criterion for Agricultural Water Used for Certain Specified Purposes ( § 
112.44(a) ) and Corresponding Corrective Measures  (§ 112.45(a) ) 
(Comment 205) Some comments support the applicability of the microbial quality 
criterion  in proposed § 112.44(a) ( i.e., no detectable E. coli) for use s 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 t o provide guidance on the specifics of a sampling plan.  
(Response)  We are finalizing proposed  § 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 § 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 § 112.51(a) and (b) in subpart F, and the definit ion of 
“agricultural tea” in § 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 1 81, 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 § 112.45(a), when your agricultural water does not meet the 
microbial quality criterion in § 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 § 112.44(a). Instead, we 
proposed that you must test th e quality of each source of the untreated surface water with an 
adequate frequency to provide reasonable assurances that the water meets the required microbial  
328 
 standard and that you must have adequate scientific data or information to support your testing 
frequency (proposed § 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 
anticipate d 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 § 112.44(a), provided that the water  meets the no 
detect able E. coli standard for those purposes. We asked for comment on the prevalence of use of 
untreated surface water for the purposes listed under § 112.44(a), and on an appropriate 
approach(es) to sampling and testing of untreated surface w ater 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 § 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 s ufficient confidence that any source of untreated surface water, given the inherent 
variability associated with such sources, will consistently meet the no detect able E. coli 
microbial water quality criterion in proposed § 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 syste ms 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 §  
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 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 en sure the safe use of such untreated 
surface water for the purposes of § 112.44(a) ; and the lack of comments persuading us to retain 
proposed  § 112.45(d), we are eliminating proposed  § 112.45(d) from subpart E  and adding a 
prohibition in § 112.44(a) on usin g untreated surface water for any of the purposes identified in 
that section .  
 
(Comment 206) One comment recommends that we establish less protective water 
quality requirement s than th ose in proposed  § 112.44(a) and § 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 pr oducts.  
(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 §§ 112.2(a) and 112.2(b) sufficiently add ress 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 b elieve that less protective water requirements along 
with labeling instructions would be appropriately protective of public health or fulfill our FSMA  
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 mandate to establish science -based minimum standards for the safe production and harvesting of 
produce th at 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 standard s. 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 c onsumed 
uncooked.    
 
(Comment 207) Some comments suggest the microbial quality requirement in proposed § 
112.44(a) should apply to postharvest  activities only.  
(Response)  As discussed in the QAR, water used for the purposes listed in § 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 § 112.44(a) to the str ingent 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 § 112.44(a) 
should be limited to postharvest  uses o nly (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  
331 
 under the same ownership would be required to comply with the  proposed  § 112.44(a) 
requirement to test water used for the listed purposes to ensure there is no detect able 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 § 112.44(a), nor is there any requirement to 
test water treated in accordance with § 112.43 used for the same purposes (see § 112.46(a)).  
See Comment 222 . In addition, we are prohibiting use of untreated surface water for these 
purposes (see § 112.44(a)), which means that only untreated ground water must be tested when 
used for these purposes (see § 112.46(c)).  
Second, a s 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 F arm(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  
332 
 houses, for example, will be considered Secondary Activities F arms, 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 F R 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)  (§ 112.44( b) and Corresponding Corrective 
Measures (§ 112.45(b) ) 
1. Microbial Quality Criteria ( § 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 § 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 kno wn 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 wa ter for irrigation. These 
comments recommend that any microbial quality standard established in a final rule should be  
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 based on data that are specific to produce safety and agricultural water. In contrast, some 
comment s support the use of RWQC in developin g the microbial quality criteria in proposed § 
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 § 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, as 
discussed in the supplemental notice, we find t hat 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 occ ur 
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 anal ysis does not distinguish 
the illness rates between different bodies of water (i.e., marine or fresh) due to incidental  
334 
 ingestion. Overall, we find the scientific rigor underlying the RWQC to be sufficient for us to 
rely on to inform our thinking on agricu ltural 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 accom panied 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 measure s specified in §§ 112.44(b) and 112.45(b)(1), 
respectively. Unlike empirical method s, model -based method s 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 determin ed 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 § 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  
335 
 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 q uality 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 cal culation 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 (inclu ding 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) 
Guide lines 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 guide lines 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 f ood 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 § 112.4 5(b)(1) were  
336 
 informed by our analysis of these WHO g uidelines.   
 
(Comment 210) In the supplemental notice, in relation to the microbial quality criteria in 
proposed § 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 shoul d 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 § 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 d istribution . 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.  
  
337 
 (Comment 211) Several comments recommend FDA set an “interim ” microbial water 
quality requirement in proposed § 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 c omments advise that such an “interi m” 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 agricultu ral water.  
(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 suggeste d 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 c onsequences 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 me ans 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 w ith various partners (s ee Comment 174). 
 
(Comment 212) Several comments recommend other approaches for us to consider in 
establishing microbial quality requirement s for § 112.44(b) uses , including: (1) using the WHO 
standard, asserting it may be easier to implement and more easily understood by foreign 
produ cers; (2) adopting a qualitative standard to require that water must be of adequate quality  
338 
 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 evaluati ng 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 standar d.  
 (Response)  See Comment 209 . The WHO guidelines present several illustrations for  
how to  reduc e 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 guid elines 
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 ) healt h 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 point s 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 § 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 requir es action by industry to ensure the criteria are  
339 
 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 § 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 § 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 c omments 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  § 112.44(c) are complicated and are likely to be confu sing and challenging for 
farmers  to implement. Some c omments 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  
340 
 provisions. Comments also ask FDA to develop guid ance 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 recogn ize 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 th ese topic s 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 day s) 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 (§ 112.4 5(b)(1)) and Other Corrective 
Measures (§ 112.45(b)(2) and (b)(3))  
(Comment 214) Several comments support proposed § 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 treat ment. In 
addition, several comments suggest that the se 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.    
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 (Response)  We are retaining the microbial die -off and removal provisions in final § 
112.4 5(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 t o, 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 cro p. Therefore, the provisions in subpart E, 
including § 112.44( b) and corresponding § 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  establish ing 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 § 112.45(b) to consolidate and clarify 
applicable  options for corrective measures  when agricultural water used during gr owing 
activities for covered produce (other than sprouts) using a direct water application method does 
not meet the microbial quality criteria in § 112.44(b) . That is, available options include  (1) 
applying a time interval (in days) between last irrigation  and harvest (§ 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 (§ 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 § 112.44(b) (§ 112.45(b)(2)); or (3) 
treat th e water in accordance with § 112.43 (§ 112.45(b)(3) ). Consistent with our intent for the 
microbial quality criteria in § 112.44(b) to serve as a long -term water management tool, we 
further clarify in § 112.45(b) that these corrective actions must be taken as soon as practicable ,  
342 
 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 wat er 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 § 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 § 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 n ot 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 o f appropriate, broadly applicable 
microbial die-off or reduction rate(s) for these purposes . Nevertheless, we provide this option  
in final § 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  
343 
 practices and conditi ons 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 under lying the microbial die -off 
rate in proposed § 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 fa rms producing different commodities across the country.   
(Response)  The microbial die -off rate in § 112.4 5(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 de pendent 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  
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 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) . There fore, in final §§ 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 § 112.45(b)(1)(i)(A), and 
would not increase the likelihood that your covered produce will be adulterate d 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 “pro viding 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 § 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 produc e production, and 
have provided options in § 112.4 5(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  
345 
 that is used in a direct application method du ring growing of produce (other than sprouts). We 
also n ote 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 § 
112.4 9(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 Comme nt 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 § 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 c omments recommend a maximum time interval 
between last irrigation and harvest of 4 days, applying a microbial die ‐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 maxi mum 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  
346 
 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 d ie-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 av ailable 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 i nterval of  four consecutive days is also consistent with  recommend ations  by 
commenters. Therefore, we are adding a new limitation in § 112.4 5(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 § 112.44( b). In addition, we expect any 
scientifically -supported die -off rate that a farm applies as an alternative under § 
112.45(b)(1)(i)(B) between last application and harvest; or to determine the ap propriate time 
interval between harvest and end of storage, in accordance with § 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  
347 
 die-off). We also expect that if you develop an alternative to the microbial quality criteria  in § 
112.4 4(b) and if you intend to take advantage of the provision in § 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 microb ial die -
off. 
 
(Comment 219) One comment requests flexibility to apply the 0.5 log per day die-off rate 
in proposed  § 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 betwe en 
last irrigation and harvest in final § 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 
propose d § 112.45, particularly in light of the microbial die -off and removal provisions in 
proposed § 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  
348 
 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 farm s should be allowed to 
“opt out” of testing requirement s for untreated surface water in  proposed  § 112.4 5(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 § 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 grow ing 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 § 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 § 112.45(b)(1) , you 
must first characterize the water quality by testing in accordance with § 112. 46(b) and calculate 
a GM and STV. Moreover, under § 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 § 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 §§ 112.45(b)(1)(i)(B), 112.49(b), and 112.12. T o do so, you must have adequate  
349 
 scientific data and information to support your con clusions , 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 § 112.45(b)(1)(i)(A) . Also, under 
§ 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 § 112.50(b)(5)) . As for the die -off or removal 
rates in § 112.45(b)(1)(i i), 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 § 
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 § 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 wa ter sources to a level 
compliant with § 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 wh ether 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 int erval. The commenter also notes,  
350 
 however, that such records should be required only in the case where the agricultural water tested 
in accordance with proposed § 112.45 does not meet the microbial quality criteria established in  
proposed  § 112.44(c).  
(Resp onse)  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 pro vision in § 
112.45(b)(1) (i) is applied to achieve the microbial quality criteria in § 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 wa ter 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 § 112.45(b)(1)(ii)  is applied to achieve the microbial quality 
criteria in § 112.44( b). Such records would be required only when such a time interval or log 
reduction is applied, in accordance with § 112.4 5(b)(1), and not when no such time interval(s) 
is applied. We are adding this records requirement in new § 112.50(b)( 6) (corresponding wi th 
our elimination of proposed § 112.161(b) ), which requires you to document any actions you 
take in accordance with § 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 § 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 (s uch 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 (§ 112. 46)  
351 
 1. Testing of Agricultural Water Not Required Under Certain  Conditions (§ 112.46(a))  
(Comment 222) Some comments believe proposed § 112.45(a) would allow farm s 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 § 112.46(a), we are retaining proposed § 112.45(a), which establishes 
that there is no requirement to test any agricultural water that is subject to the requirements of § 
112.44 when: (1) you receive water from a public water system, under the con ditions specified in 
that provision (§ 112.46(a)(1)); (2) you receive water from a public water supply that furnishes 
water that meets the microbial quality requirement in § 112.44(a), under the conditions specified 
in that provision (§ 112.46(a)(2)); or y ou treat water in accordance with § 112.43 (§ 
112.46(a)(3)).  
This exception from the testing requirements that follow in § 112.46(b) and (c) applies 
only when water received from a public water system (as in § 112.46(a)(1)) or a public water 
supply (as in  § 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 § 112.3(c). If you hold water rec eived 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 § 112.46(b) and (c).   
352 
 We are also revising § 112.46(a)(1) to add a reference t o 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 o f 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 S tates 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, d isapprove, and 
promulgate water quality standards as authorized by section 303(c) of the C WA (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, m any farms rely on di tches to direct water to the field , and t hese ditches are normally 
open to the environment and can cover significant dista nces.  There are no controls in the CWA 
that would account for  potential  contamination in th ese ditches.  
  
353 
 2. Approach to Testing Untreated Surface Water (§ 112.4 6(b)) and Untreated Ground Water (§ 
112.46(b) and ( c))  
(Comment 224) Several comments support the revisions we proposed in the supplemental 
notice to proposed § 112.45 that we had proposed in the 2013 proposed rule. These c omments 
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 c omments also find the proposed tiered approach l ess burdensome than the originally 
proposed requirements. Conversely, several other comments state the revisions to proposed § 
112.45 proposed in the supplemental notice result in a testing scheme that is overly complicated, 
burdensome, lacks scientific ju stification, 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 w ater 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 § 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 parti cular, 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  
354 
 more flexible by proposing tiered approaches to testi ng untreated surface water ( proposed § 
112.45(b)) and untreated ground water  (proposed § 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 
§ 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 corr ective 
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 
establish ing in our testing scheme for untreated surface water in § 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 establish ing in § 112.46( b).  
355 
 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 agricultur al 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 practi ces and conditions on their farm. In addition, in new § 112.49(c) and (d), 
we are  allow ing, 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 surve ys 
under § 112.4 6(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 ne w § 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 frequenc ies. 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 § 112.4 7(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 § 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 th at 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  
356 
 ground water used for § 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 § 
112.45(c).  
In addition, we are revising proposed § 112.45(c) to separately address the testing of 
untreated ground water  when used for purposes of § 112.44(a) (see final § 112.46(c)) . 
Similarly, in final § 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 § 112.44(a), 
as proposed in the supplemental notice in proposed § 112.45(c).  
 
(Commen t 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 untreated ground 
water  used for § 112.44(b) purposes represent science -based minimum standards for the safe 
production and ha rvesting 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 esti mation of the microbial  
357 
 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 § 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 ea ch State to develop its 
own testing regime for ensuring water meets the microbial quality standard in proposed § 
112.44(c), subject to FDA approval. This commenter believes such an approach would allow 
States to tailor testing requirements to the unique ci rcumstances 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 § 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 § 112.46(b)), whereas the provisions for alternatives under § 112.49(c) and (d) are restricted 
only to the use of alternative testing frequencies in lieu of the frequencies we i dentified in § 
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 § 112.46(b) more broadly.  
  
358 
 (Comment 227) Some comments assert that the proposed testing frequency requirements 
in proposed § 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 untreate d 
surface water and untreated ground water sources in § 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 environment al 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 i f a farm  is receiving water  
359 
 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 far m, 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 t ake 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 § 112.46 
when applicable. Te st 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 i n 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 a n 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 a dequately 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  
360 
 described in subpart N of part 112  and cross -referenced in new § 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 test ing 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 c omments 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 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 u sing the 0.5 log per day die -off rate, based on input of sample data, such 
that farm s would not need to perform the necessary calculations themselves .  
  
361 
 (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 § 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 § 112.4 6(b) require samples to be colle cted as 
close in time as practica ble 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 use d to determine the appropriate use of that water. In § 
112.3(c), w e 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, incl uding 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 p roduce (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  
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 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 
Registe r), FDA is establishing requirements for importers to verify that imported food, 
including produce, is produced in compliance with applicable FDA food safety regulations, 
including th is 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 impor ted 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 w ill 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 sourc es 
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 i nstead 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 adopt ing for 
water testing in § 112.46 is responsive to comments that requested that we establish a risk -based,  
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 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 micro organisms, 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 fr om 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 ex ample, 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 source s 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 § 112.44(b) , we require a 
lesser frequency of testing for ground  water than for surface water sources  (see § 112.46(b)) . We 
acknowledge  that ground water sources can become contaminated, for example, if they are  
364 
 improperly maintained. The testing frequencies established in § 112.46 for such sources, and the 
requirements in § 112.42 to regularly inspect and maintain such sources, are desig ned 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 pr oposed 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 “ ground 
water” in § 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 influe nced 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 in to 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  
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 water.” Thus, where a ground water source is directly influenced by surface water, it no longer 
meets the definition of “gro und 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 definiti on 
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 § 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 n umber 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 § 112.46(b)(1)(i)(A) or § 112.46(b)(2)(i)(A). To account for such circumstances, w e 
are providing in § 112.49(c) and (d) for the use of an alternative testing frequency (in lieu of 
those required in § 112.46(b)(1)(i)(A) or § 112.45(b)(2)(i)(A)), under the conditions specified in 
§ 112.12. On the other hand, because ground water sources (as we have defined “ground water” 
in § 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 § 112.46(b)), and no  alternative option for different testing frequencies is available for 
ground water sources.  
  
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 (Comment 233) Several comments state the importance of making sure that water tests 
are conducted properly by certified and accredited labs. Some c omments 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 § 112. 151, as required under § 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 t he 
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 defi nes 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. Timi ng of Collection of Water Samples for Testing Required Under § 112.4 6(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  § 112.45(b) and/or § 112.45(c). Some c omments point out the time period for 
harvesting varies across regions and ranges from a few days to several months or year round.  
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 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, har vest (see § 112.46(b)(1)(ii) and § 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 sampli ng 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  wildli fe 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 peri od(s) as close as practicable  
368 
 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 contaminati on 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 provide adequate variation as 
the d istribution 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 ag ricultural 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 § 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 harvest ing 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 recu rring patterns of water quality variations are often seen on an annual  
369 
 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 § 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 applicabl e, using a minimum total of four samples 
collected to be representative of the intended use(s) (see § 112.46(c)).  See Comment 229.  
 
4. Clarification of Terms Used in § 112.4 6 
(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 § 112.44(b) and make a decision regarding corrective measures, as necessary, 
under § 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 § 
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 §  
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 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 
wate r, 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 thre shold 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 § 
112.4 6(b) a nd (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, w e are specifying in § 112.4 4(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 STV s 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 rat e) based on input of sample data, such that a farmer would not need to perform 
the necessary calculations themselves.  
  
371 
 (Comment 237) Several comments request clarification on the meaning of the term 
“water source,” as it relates to the water testing requirements in proposed § 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 wheth er 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 agr icultural 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 surf ace 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 tha t 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  
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 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 b e a surface water source) . Where water testing 
requirements apply, they apply 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 fiel ds. 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 system s 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 § 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 co llect 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 § 112.46( b) and (c)).  
 
5. Minimum Number of Samples for Initial Survey (§ 112.4 6(b)(1)(i) (A)) and/or Annual 
Survey (§ 112.4 6(b)(2)(i) (A)) Related to Testing of Untreated Surface Water Used in a Direct 
Water Application Method During Growing Activities   
373 
 (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.  
Thes e 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 f inalizing in §  112.46(b)  
for untreated surface water used for § 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 § 112.44(b) , given certain expectations about 
the variability of that source. For untreated surface water sources, where measurements of log 10 
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 conce rning 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 sur vey data within a moving window of 
observations collected over multiple years. However, based on an assessment of the magnitude 
of bias in estimates of log 10 GM and log 10 STV for hypothetical changes in population log 10 
GM, a minimum sample size of 5 for a nnual surveys, being 25  percent  of the minimum of 20  
374 
 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 p rofile 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 § 112.4 6(b)(1)(i) and 5 samples for the annual 
survey required under § 112.4 6(b)(2)(i). To provide flexibility and account for sources of water 
that have less variability in their quality than that assumed i n our calculations, we are providing 
for the use of an alternative testing frequency in lieu of the required minimum number of 
samples, in §  112.49(c) and (d) , provided the conditions  in § 112.12  are met . With respect to 
comments about USDA’s GAP guideline s, 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 § 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 commo dities 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  
375 
 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 
comm ent 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 s urface 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 
farm s 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 cond itions of use of the water based on certain expectations about the average 
variability of log 10 E. coli abundance  (Ref. 99) . Therefore, we are retaining the requirement for a 
minimum sample size of 20 samples in § 112.4 6(b)(1)(i) (A). However, we acknowledge the 
concerns commenters raised about the impracticability of collecting 20 samples 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  
376 
 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 sample s over more than 2 years. We believe a minimum 
period of 2 years  is necessary to provide an adequate representation of t he 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 th an 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 per iod 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 yo ur 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  
377 
 is lower than that required in § 112.4 6(b)(1)(i) (A) or § 112.4 6(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 minimu m number of samples  (see § § 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 farm s, with no appreciable increase to produce safety. These c omments 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 § 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 activi ties 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, § 112.46(b) among them (except § 11 2.46(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 XX IV for compliance dates for covered activities involving sprouts, 
which are subject to a ll of part 112 including subpart M). We also have included certain size -
based provisions, including a coverage threshold and a qualified exemption described in §§ 
112.4 and 112.5.   
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(Comment 242) Several comments oppose the minimum sample size of five samples for 
the annual survey, under proposed § 112.45(b)(2)(i), stating that such a frequency of testing is 
unnecessary, burdensome, and not scientifically determined. These c omments suggest differ ent 
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 § 112.4 6(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 (§ 112.4 6(b)) 
(Comment 243) Some comments note farms currently conduct water testing (including, 
for example, consistent with relevant industry guidelines) and maint ain 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 § 112.46(b)(1) 
for untreated surface water used in growing covered prod uce 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.  
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 We do not expect farms to incur addi tional sampling costs to satisfy the initial survey 
requirement in § 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 
§ 112.46(b). Un der 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 ha ve 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 § 112.46, except § 112.46(a) and 
(b)(1) with respect to untreated surface water, for c overed activities involving covered produce 
(except sprouts).  
We exclude § 112.46(b)(1), with respect to untreated surface water only, from the 2 -year 
extended compliance period provided for the remainder of § 112.46 because, in order to comply 
with the m icrobial 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 rule for very 
small farms; not later than 3 years after issua nce 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 m inimum 20 samples  
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 necessary to develop the microbial water quality profile required under § 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 ye ars 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 sufficie nt 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 § 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 § 112.46(b) until 5 and 6 years, respecti vely, 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 § 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 § 112.46(b)(1)(i)(A) and (B)).  
Note  that the exclusion of § 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 § 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.   
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 We are also excluding § 112.46(a) from the extended compliance period because this 
provision provides an important exception to the testing r equirements in § 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 c overed activities involving sprout s, as discussed in section  XVIII .J 
of this document . Therefore, covered farms  must comply  with all of the applicable requirements  
of part 1 12, 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 (§ 112.4 6(b)(2))  
In the supplemental notice, we acknowledged that there are certain limitations to our 
proposed tiered app roach, 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 § 
112.45(b)( 1)(iii)(A) , and, instead, recommend applying a rolling set of samples such that the  
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 water quality profil e is updated on an ongoing basis. Similarly, o ne 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 ru le 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 provi sions 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 (§ 112.46(b)).   
We are revising our tiered approach to testing by, first, elim inating (1) the proposed 
requirement to develop a new water quality profile at least once every 10 years (proposed § 
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 § 112.44(c), you must develop a new water quality profile (pr oposed § 
112.45(b)(2)(ii)).  
Second, in lieu of the eliminated provisions, we are adding these revised requirements in 
final § 112.46(b)(2): (1) Following the development of the microbial water quality profile based 
on an initial survey, you must test wate r annually to update your existing microbial water quality  
383 
 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 (§ 
112.46(b)(2)(i) and (ii)); and (2) To update the microbial water quality pr ofile, 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) (§ 112.46(b)(2)(iii)); and (3) You must modify your water use, as 
appropriate, based on the revised GM and STV values in your updated water quality profile, in 
accordance with § 112.45 (b)(1) through (3) (§ 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 advantage s 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 fr equency 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 followin g 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  
384 
 associated with use of the water. Moreover, the revised approach established in § 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 appro ach, codified in § 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 us e 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.   
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 This approach also alleviate s 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 
generi c 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 § 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 § 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 C FU 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  
386 
 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 be tween 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 sufficient ly high level  (spike ) in even one sample can elevate the G M (and/or STV) over the 
microbial  quality  criteria in § 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 th e 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 ir rigation 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 §  
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  
387 
 changes in adjacent land use that are reasonably likely to adversely af fect 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 calcu late 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 at least 20 samples or 4 samples (for untreated surface water, or untreated ground 
water, respective ly). 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 § 112.45(b) (see § 
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 tes ting 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 § 
112.46(b), such water sources would be subject to the same testing requirements as all other  
388 
 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 § 
112.46(b) to allow farms to independently determine, in compliance with §§ 112.49(c) and ( d) 
and 112.1 2, 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 wate r 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 § 112.4 6(b) and developing a microbial water 
quality profile. If the GM or STV do not meet the microbial quality criteria in § 112.44(b), then 
you must consider and implement the options provided in § 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 (§§ 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 qualit y 
profile. Some c omments 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 c omments also poin t out the proposed provisions  
389 
 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 § 112.46(b), you wi ll 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 § 112.44(b), you must take 
actions in a ccordance with § 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 informat ion and 
clarification on follow -up corrective measures that are required under the different provisions, 
including in response to results of testing required in § 112.46 and/or in response to your 
knowledge or determination that water is not safe or of ade quate sanitary quality and/or does not 
meet the microbial quality criteria in § 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 
establis hed 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  
390 
 has started operation upstream from the farm and within a close distanc e 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, un der § 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 § 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 f arm 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 it s 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 un der § 112.41 because the water is reasonably likely to contain human pathogens  
391 
 transferred by the dead and decaying deer. Therefore, under § 112.45(a), the farm must 
immediately discontinue using the water for irrigation until it completes one of the actio ns 
described in § 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 th at 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 (§ 
112.45(a)(1)). In this cas e, 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 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 irri gation of its covered produce.  
Example 3: Exceedance of no detectable generic E. coli criterion in § 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  
392 
 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 detect able generic E. coli is found, thus 
exceeding the required criterion in § 112.44(a) . Under § 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 
purpose s until it completes one of the actions described in § 112.45(a). The farm’s choices are to 
re-inspect th e 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 ne cessary changes, and take 
adequate measures to determine if the changes were effective (§ 112.45(a)(1)), or to treat the 
water in accordance with § 112.43 (§ 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 § 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  purpose s (see § 112.44(a)). If the 
circumstances  allow the farm to use § 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 § 112.44(a) (see § 112.45(a)(1)). 
Making necessary changes to address the identified  conditions (as required by § 112.45(a)(1)) 
also includes steps such as cleaning affected food contact surfaces, for example. Moreover, under 
§ 112.46(c), the farm must also test the well at least four times per growing season or year in the 
next year beca use of the test result that failed to meet the microbial quality criterion in §  
393 
 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 i n § 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 § 112.44(b) (so no time 
interva ls 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 § 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 § 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 f arm has adequate 
supporting scientific data and information in accordance with § 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 op tions in § 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  
394 
 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 § 112.43. If none of the above mitigation options are selected and appropriately 
applied to achieve the microbial water quality criteria, the farm mus t 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 § 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 co rrected 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 § 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 ha s been made to adequately ensure that the water meets the microbial 
quality criteria in § 112.44(b) (see § 112.45(b)(2)). Under § 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 § 112.46(b)(2) for  the annual survey,  
395 
 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 earl ier (such as immediately post -correction, even if not 
close in time to harv est) 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 S TV 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 m ake 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 quality profile are likely to be r are (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 § 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 ca used 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  
396 
 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 a pplication 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 exceed ing the microbial water quality criteria in § 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 § 112.45(b) that must be taken when the 
microbia l water quality criteria in § 112.44(b) are not met involve longer -term decisions (rather 
than the immediate decisions required under § 112.45(a)) about the use of that water as soon as 
practicable (considering crop in the field, next harvest, or next grow ing 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  
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 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 reas on 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 § 112.44(b) and the 
corresponding testing scheme in § 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 § 
112.45(b)(1) through (b)(3), a requirement to immediately implement corrective a ctions on the 
current crop during growing or harvested crop solely based on the results of § 112.46(b) is not 
warranted. Rather, we conclude the general requirement in §§ 112.41 and corresponding 
112.45(a) sufficiently address those circumstances and neces sary immediate actions when 
water is not safe or of adequate sanitary quality for its intended use.  
 
H. Sharing of Water Testing Data (§ 112. 47(a) ) 
(Comment 248) One comment requests that FDA provide for the establishment of water 
quality profiles for comm on water sources affecting various farms in a specific geographic area 
or region.  
(Response)  Section 112.4 7(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 § 112.46(b) on a regional basis for large water sources such 
as rivers. As provided in § 112.47(a)(2), you may use data collected by a third party or parties  
398 
 only if the wat er 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 represent s 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 p rovision, 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 w ork 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 C FR 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  
399 
 SDWA public water supply program, we note that under § 112.4 6(a)(1), there is no 
requirement to test any agricultural water that is subject to the requirements of § 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 § 112.45(b), rather than 
having to co nduct a new baseline survey.  
(Response)  Under § 112.4 7(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 applica ble requirements of the rule are met. A water 
source sampled by a third party adequately represent s 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 reaso nably 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 § 112.47(a)(2), the farmer may use such data to satisfy relevant 
testing requirements under § 112.46, including those required under § 112.46(b). On the other 
hand, if a farmer  of a leased land does not have access to pr evious years’ water testing data , or 
the farmer has access to such data but those data do not meet the requirements of § 
112.47(a)(2), the farm will need to perform its own testing  to develop the initial microbial  
400 
 water quality profile .  
 
I. Agricultural Water Used During Harvest, Packing, and Holding Activities (§ 112.4 8) 
(Comment 251) Some c omments 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 112.4 8(b) requires you to visually monitor the quality of water that 
you use during harvest, packing, and holding activities for covered p roduce (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 ) 
establish es a microbial quality criterion for such water and prohibits using untreated surface 
water for such purposes. We consider the § 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 § 112.44(a) microbial criterion . In addition, § 
112.46(a) establishes the circumstances in which water used for the purposes listed in §  
401 
 112.44(a) is not required to be tested, and § 112.4 6(c) requires testing untreated ground water  
used for the se 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 § 
112.44(a), a gricultural 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 pr oduce during or after harvest activities , we are not requiring 
treatment of re -circulated water. Instead, we have provided flexibility for farms to implement  
402 
 measures appropriate to their practices to comply with § 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 co mmodities. 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 
demonst rated 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 cons idered 
proposing a specific  temperature differential between water and product core temperature ( e.g., 
water must be at least 10 °F warmer than core) , and tentatively concluded that there is 
insufficient scientific evidence supporting the application of su ch a specific temperature 
differential requirement across all covered produce. Instead, we proposed and now finalize § 
112.4 8(c), which requires that you must maintain and monitor the temperature of water at a 
temperature that is appropriate for the commod ity and operation (considering the time and 
depth of submersion) and is adequate to minimize the potential for infiltration of  
403 
 microorgani sms of public health significance . Thus, the requirement is tailored to apply only to 
appropriate commodities and prac tices, 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 
toma toes, 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 even under a zero temperature 
differential, and temperature differentials up to 10 °F have no effect on the internalization 
frequency and have limited impact on Salmonella  spp. cell populations internalized in 
tomato es. 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 Relat ed to Agricultural Water (§ 112.50)  
(Comment 254) In response to the 2013 proposed rule, seve ral comments support the 
record keeping requirements of proposed § 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 farm s must establish and keep records relating to the 
findings of the inspection of the agricultural water system; the results of any analytical tests  
404 
 conducted to determine whether water is safe and of adequate sanitary quality for its intended 
use; and scientific data relied on to su pport 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 correcti ve 
actions and compliance with the relevant requirements . In proposed § 112.161(b), we proposed 
a general provision applicable to records required under subpart s 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 § 112.161(b) and, 
instead, adding that requirement within the records provisions of two relev ant subpart s, 
subpart s E and M . In subpart E a s edited, under new § 112.50( b)(6), you must establish and 
keep documentation of actions you take in accordance with § 112.45 . For example, if you 
determine that water you use for a purpose listed in § 112.44(a ) does not meet the microbial 
quality criterion established in that section, § 112.45(a) provides that you must take certain 
steps as a result. This § 112.50(b)( 6) requires that you establish and keep documentation of the 
steps taken to satisfy § 112.45(a) . In addition, in this section we are also establishing specific  
requirement s for documentation of time intervals or calculated log reductions applied  in 
accordance with § 112.45(b)(1).   
405 
 We are also adding new § 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 § 
112.151 (a). Under § 112.151( b)(1), you may use any scientifically valid method tha t is at least 
equivalent to the method of analysis in § 112.151(a) in accuracy, precision, and sensitivity  to 
satisfy the water testing requirements under § 112.46 . In addition, under § 112.151(b)(2), if you 
use an alternative indicator of fecal contaminat ion in accordance with § 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 p rovision is consistent with proposed § 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 t wo proposed 
records requirements related to water testing results (proposed § 112.50(b)(2) and (5)) into one 
requirement in final § 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 § 112.42.  
(Response)  Under § 112.50(b)(1), you are required to establish and keep records of your 
agricultural water system inspection findin gs under  § 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 § 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  
406 
 monitoring, an adequate description of covered produce applicable to the record, the locatio n of 
a growing area or other area applicable to the record, and the date and time of the activity 
documented. Under § 112.161 (a)(2), records must be created at the time an activity is 
performed or observed, under § 112.161 (a)(3) they must be accurate, legi ble, and indelible, and 
under § 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 tha t is appropriate for the farm’s operation 
provided that the records contain all necessary information and satisfy subpart O. Under § 
112.163(a), y ou 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, § 112.163 provides you the flexibility 
to keep any additional information required either separately or combined with your e xisting 
records, even where the formats for each record may not be the same.  
 
K. Compliance Periods Relat ed to Agricultural Water  
For covered activities involving covered produce  (except sprouts  subject to  subpart M ), 
the compliance dates for water quality requirements in § 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.   
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. 
Compliance Dates of 2-4 years Applicable to the Farm 
Based on its Size Extended Compliance Date of Additional 2 years 
Beyond the Compliance Date Based on Size of Farm 
§ 112.41  
§ 112.42  
§ 112.43  
§ 112.45(a) with respect to safe and adequate standard  
§ 112.46(a)  
§ 112.46(b)(1) with respect to untreated surface water  § 112.44  
§ 112.45(a) with respect to § 112.44(a) criterion  
§ 112.45(b)  
§ 112.46(b)(1) with respect to untreated ground water  
§ 112.46(b)(2) and (b)(3) § 112.46(c)  
  
407 
 § 112.47  
§ 112.48  
§ 112.49  
§ 112.50  
 
Note that although most of § 112.4 6 is subject to the  extended compliance periods, § 
112.46(a) is not, and § 112.4 6(b)(1) with respect to untreated surface water is not . Therefore, 
covered farms must initiate actions in compliance with § 112.4 6(a) and , with respect to untreated 
surface water,  § 112.46 (b)(1) under the regular compliance per iods applicable to the remaining 
sections of this rule . Similarly, § 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 2 43 for an explanation for treating § 112.4 6(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 o f 
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 § 112.44( b), the microbial die -off rate in 
§ 112.4 5(b)(1)(i), or the testing frequencies in § 112.4 6(b)(1)(i) (A) and § 112.4 6(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 y ears from the effective  
408 
 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 specifi c 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, d epending on size of the farm. See also 
section XXIV .A of this document  for additional information.  
  
  
409 
 XIV. Subpart F – Comments on Biological Soil Amendme nts 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 deat h 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 adult erated under section 402 of the FD&C 
Act. In the 2013 proposed rule and the supplemental notice, w e asked for comment on our 
proposed provisions, including our decision not to establish  requirements for chemical or 
physical soil amendments, or biological s oil 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 appl ication 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 min imum 
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 s tandards 
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.   
410 
 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 
§ 112.3, which are described in section IX of this  document.  
Table 13.-- Description of Revisions to Subpart F  
Final Provision  Description of Revisions  
§ 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 § 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  
§ 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 o f this rule  
- Revision to (c) to rep lace “that has become” with 
“that you know or reasonably believe may have 
become”  
- See Table 15 for additional information  
§ 112.53  - No change  
§ 112.54  - Revision to (a) and (b) to add biological processes 
and replace “demonstrated” with “validated”  
- Rearrang ement 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  
- Revis ion 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  
§ 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  
§ 112.56  - Revision to (a) to delete “exc ept 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 § 112.54(b)  
- Renumbering of proposed (a)(2) as (a)(3)  
- See Table 19 for additional information   
411 
 § 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 § 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 spe cial 
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 amendment s of animal origin, including 
raw manure.  Some comment s 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 ro ute of contamination on farm and, therefore, we do not believe it would be 
sufficient merely to make recommendations related to biological soil amendment s 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 amendment s of animal origin, 
including raw manure, which  was proposed in the 2013 proposed rule and withdrawn in the 
supplemental notice , see Comment 257 .    
412 
  
(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 rec ommended 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 lo ng as they are applied in accordance with § 
112.56. The provisions of § 112.54 allow for biological (including composting), chemical, and 
physical treatment processes, or combinations thereof, for producing treated biological soil 
amendment s of animal origin, as long as they meet the microbial standards in § 112.55. We do 
not believe it would be appropriate to broadly adopt USDA’s NOP standards for biological soil 
amendment s of animal origin because they were established for purposes of orga nic 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 industry, is  
413 
 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 amendment s of 
animal origin, including raw manure, in response to our original proposal we recei ved 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 5846 0-5846 1) that we were deferring 
action on an application interval until we pursued certain steps i ncluding 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 pri or to establishing an application interval for untreated 
biological soil amendment s 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 assess ment 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  
414 
 intervening 5 -10 years while FDA pursues its ri sk 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 c onduct 
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 amendment s 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 amendment s 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 amendment s 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 resea rch  
415 
 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 appli cation interval for 
untreated biological soil amendment s 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 s tandard, established in part 112, is necessary to minimize the likelihood of 
contamination of produce resulting from the use of untreated biological soil amendment s of 
animal origin, including raw manure, in a manner that contacts covered produce. We 
ackno wledged 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 c rop 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 amendment s of animal origin such 
as raw manure. Given that the scientific lit erature demonstrates that the probability of pathogen 
survival decreases as the length of time between application of untreated biological soil 
amendment s of animal origin and harvest increases, and that more rapid die -off occurs during the 
months immediat ely 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 
contamina tion 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.    
416 
  
(Comment 259) One comment recommend s only stabilized compost tha t 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 (§  112.52(b)) and that it should be considered untreated if it has become 
contaminated (§  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 amendment s 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 request s only mammalian and avian species be included in 
the definition of “biological soil amendments of animal origin” and therefore subject to the 
requirements of subpart F.  
(Respon se) 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.  
417 
 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 amendment s from all animal sources should be addressed through 
inclusion in the term “biological so il 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 div erse, 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 ri sk 
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.   
418 
 (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 reasona bly 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 synthet ic 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 amendment s 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 amendment s of animal origin incentivizes the use of chemical 
fertilizers. However, we did conside r the effect of farms switching to chemical fertilizers in the 
EIS and concluded that a switch away from biological soil amendment s of animal origin to 
chemical fertilizers could cause moderate adverse environmental impacts to soils, but not to a 
significa nt 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 h ealth and biological soil 
amendment s 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 trimmin gs 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  
419 
 composting bef ore 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 comp ost, 
suggesting that “green waste” should not be treated as less risky than biological soil amendment s 
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 so il 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 § 112.3(c) st ipulates 
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 materia l 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 -consume r 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 n ot likely to contain significant animal waste or human waste (e.g., yard  
420 
 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 pres ence 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 t o 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 contai ning 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 § 112.52(a) requires th at 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 s ources, 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 am endment 
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 
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.   
  
421 
 (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 s torage 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 request s clarification on whether “table waste” would be 
an example of a biological soil amendment of animal origin.  In addition, other c omments 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, instit utions, restaurants, retail operations, or other 
sources where the food has been served to a consumer” (§ 112.3(c)). Table waste is explicitly 
included within the definition of “biological soil amendment of animal origin” in § 112.3(c), 
making it subject t o 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  
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 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 t o 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 considere d “pre -consumer vegetative waste” (and therefore not 
subject to the requirements in subpart F) if it meets the terms of that definition (§ 112.3(c)). 
Notably, we are defining “pre -consumer vegetative waste” in part to require that these materials 
may not h ave come in contact with animal products, bypr oducts 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 t o the requirements of subpart F. We 
acknowledge that a variety of feedstocks may be used to produce treated biological soil 
amendment s 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 §§ 112.54 and 112.55, we conclude that the end product may be 
used in accordance with requirements for treated biological soil amendment s of animal origin 
rather than untreated biological soil amendment s of animal origin in § 112.56. We note that, 
depending on the level of treatment received, the end products present d iffering levels of risk 
reflected in the different application requirements established in § 112.56.    
423 
  
(Comment 266) One comment request s FDA not subject manure from grass -fed animals 
to the requirements of subpart F. The comment state s 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 su pport 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. The se comment s 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 a pplicable to that covered farm.  In addition, the 
requirements we are establishing in § 112.56 allow use of both treated and untreated biological 
soil amendment s of animal origin in situations where there is no contact between the covered 
produce and t he 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 gr eater 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.    
424 
 (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 a ssociated 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. 17 1). 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. 12 6). 
 
(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. The comment further state s 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 o rigin, 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 (§ 112. 3(c)) and are therefore not subject to this rule.  Sweet corn  
425 
 is exempt from the rule because it is on the list of produce that FDA has determined is “rarely 
consumed raw” in § 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 dis cuss agricultural tea as having unique food 
safety risks and request that FDA address agricultural teas separately within § 112 .56. These 
comments ask FDA to establish reasonable, scientifically based minimum application intervals 
for use of agricultural t eas 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 provide s two literature citations to argue 
that pathogens such as E. coli and Salmonella , are poor at survi ving on plants and are quickly 
overrun by normal, plant colonizing bacteria. The comment argue s that more significant risks are 
posed by anaerobically prepared manure or non -NOP compliant agricultural teas, which the 
comment argue s should be banned from us e as soil amendments.  
(Response)  FDA agrees that agricultural teas that are biological soil amendment s of 
animal origin (see Comment 271 ) should be regulated similarly to other biological soil  
426 
 amendment s of animal origin, with appropriate attention given t o their unique qualities, and we 
believe we have done so in this rule. Under § 112.51, the components of an agricultural tea (of 
animal origin) must be processed to the same standards as other biological soil amendment s 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 §§ 
112.51(a) and (b)(1)) and the heightened risk presented by the use of agricultural tea additives 
(see § 112.51(b)(5)). We consider that, in connection with the provisions of § 112.51 just 
described, the treatment processes described in § 112.54 and the microbial standards of § 112.55 
are adequate for all biological soil amendments of animal origin, in cluding agricultural teas (of 
animal origin), and it is not necessary to also include a separate section in § 112.56 regarding 
agricultural teas (of animal origin). We have addressed the unique risks of agricultural teas (of 
animal origin) by limiting in §  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 § 112.56(1)(i) or (ii).  In addition, like all other biological soil amendment s of 
animal origin, agricultur al teas (of animal origin) must be considered untreated and applied in 
accordance with § 112.56(1)(i) or (ii) if they fall within any of the categories in § 112 .51(b) (for 
example, if the biological materials of animal origin used to make the tea are not p rocessed to 
completion in accordance with the requirements of § 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 dat a or information supporting that assertion. However,  
427 
 we note that under §§ 112.56(a)(2) or (a)(3), biological soil amendment s of animal origin that are 
agricultural teas prepared from properly handled stabilized compost (i.e., biological materials of 
anima l origin are processed to completion in accordance with § 112.54 to meet relevant 
microbial standards in § 112.55; made with water satisfying the requirements of § 112. 51(a); and 
not otherwise considered “untreated” under § 112.51(b)) have an application i nterval of zero 
days, and application method restrictions that vary based only on the level of treatment provided 
by the processing.  Under § 112.56(a)(1), other biological soil amendment s of animal origin that 
are agricultural teas and that are considered “untreated” under § 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 Comm ent 257  regarding our plans relating to a minimum application interval for 
untreated biological soil amendment s of animal origin applied in a manner that contacts covered 
produce.    
With regard to the comment about anaerobic preparation, FDA does not consi der 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 fo r 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) .   
428 
  
(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 § 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 teas may be applied in some cases fo r 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 t hat 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 amendment s of animal origin, and not the requirements in subpart E that apply to 
agricultural water. We are removing the reference to agricultural te a in subpart E of this rule, in 
proposed § 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 § 
112.44(a) for the resulting agri cultural tea to be considered “treated” under § 112.51 in subpart F. 
Whether a biological soil amendment  of animal origin is “treated” or “untreated” under § 112.51 
affects the application restrictions that apply to its use in § 112.56. However, we do not intend to  
429 
 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 de finition of “agricultural tea,” and revising to § 
112.51(a) and (b)(1) to clarify this. As revised, § 112.51(a) provides that “a biological soil 
amendment of animal origin is treated if it has been processed to completion to adequately 
reduce microorganism s of public health significance in accordance with the requirements of § 
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, § 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 § 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 surfa ce 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,  
430 
 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 state s 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 state s that compost extracts without 
“com post 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 amendment s of animal origin similarly  to other biological soil 
amendment s 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 § 
112.3(c).  Further, this rule does distinguish bet ween agricultural teas, as we have defined that 
term in § 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 -consume r 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 th an 
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 § 112.56 in  
431 
 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 amendment s of animal origin as compared to other biological soil 
amendment s 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 amendment s of animal origin in 
subpart F.  
 
(Comment 273) One comment argue s 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 
amendment s 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 amend ment s of animal origin, thus requiring that there be some component of 
animal origin in the biological soil amendment  feedstock (or, in the case of § 112.53, human  
432 
 waste).  To improve clarity, we are amending the three appearances of the term “agricultural tea” 
in § 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  (§ 112.51)  
In proposed § 112.51, we proposed to establish requir ements for determining the status of 
a biological soil amendment of animal origin a s being treated or untreated, for use in covered 
activities. In  Table 14, we describe the codified provisions of § 112.51 and any changes we made 
to those provisions in the final rule. Comments specific to § 112.51 follow the table.   
Table 14.-- Description of Revisions to § 112.51  
Proposed 
Provision  Proposed Language  Final Revisions, if Any 
§ 112 .51(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 § 112.54, or in the case of an agricultural tea, 
the biological materials used to make the tea have 
been so processed and the w ater used to make the 
tea satisfies the requirements of § 112.44(a)  Revised to clarify that agricultural teas 
covered are those for which the biological 
materials include materials of animal 
origin , , and to replace reference to § 
112.44(a) with clarifying  text.  
§ 112.51(b)(1)  A biological soil amendment of animal origin is 
untreated if: (1) It has not been processed to 
completion in accordance with the requirements of 
§ 112.54, or in the case of an agricultural tea, the 
biological materials used to make the tea have not 
been so processed or the water used to make the 
tea does not satisfy the requirements of § 
112.44(a)  Revised to clarify that agricultural teas 
covered are those for which the biological 
materials include materials of animal 
origin , and to replace reference to § 
112.44(a) with clarifying text .  
§ 112.51(b)(2)  A biological soil amendment of animal origin is 
untreated if: (2) it has become contaminated after 
treatment;   No change  
§ 112.51(b)(3)  A biological soil amendment of animal origin is 
untreated if: (3) it has been recombined with an 
untreated biological soil amendment of animal 
origin  No change  
§ 112.51(b)(4)  A biological soil 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  No change  
§ 112.51(b)(5)  A biological soil amendment of animal origin is 
untreated if: (5) it is an agricultural tea that 
contains an agricultur al tea additive  Revised to clarify that agricultural teas 
covered are those for which the biological 
materials include materials of animal  
433 
 origin.   
 
(Comment 274) A comment recommend s 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 § 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 (st arting 
material). Application restrictions for treated and untreated biological soil amendments of animal 
origin are described in § 112.56.  
 
(Comment 275) One comment generally agree s with our regulatory descriptions in § 
112.51(b) of biological soil amendments of animal origin that are untreated, but asked us to 
modify § 112 .51(b)(4) so that if any discrete component of a soil amendment is untreated, the 
entirety is considered untreated. The comment argue s that whether any un treated 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 untreate d, 
the entirety is considered untreated. However, such situations are addressed in § 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 § 
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  
434 
 such cases, FDA concludes that yo u should be required to consider the biological soil 
amendment  to be untreated for purposes of subpart F, including the application restrictions in § 
112.56.  If there is reason to think that materials used in a biological soil amendment  of animal 
origin ar e 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 §§ 112.54 and 112.55.   
 
(Comment 276) One com ment 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 cite s a reference  (Ref. 175)  which , according to the 
comm enter,  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 argue s 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 additi ves 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 increa se 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 bi ological 
materials of animal origin used as feedstock for an agricultural tea meet the microbial standards 
of § 112 .55(a) or the microbial standard of §  112.55(b), when an agricultural tea additive is used,  
435 
 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 produc e 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 i nconclusive 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 si gnificance 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 Kan nangara (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 
productio n and use of agricultural tea additives become established, we will consider appropriate 
next steps, including possibly revisiting these requirements.  
  
436 
 (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 amendment s of animal origin (such as static compost, 
vermicom post, 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 amendm ents may not 
pose the same risks as raw manure.  
(Response)  We disagree that our requirements would result in all the listed biological soil 
amendment s of animal origin being subject to the same requirements as raw manure. Section 
112.51 distinguishes betwe en ‘treated’ and ‘untreated’ biological soil amendments of animal 
origin, and § 112.56 describes the application restrictions that apply to biological soil 
amendment s of animal origin depending on whether they are treated or untreated (and if treated, 
depe nding on which level of treatment they received). The provisions of § 112.51 refer to the 
treatment processes of § 112.54, which in turn refers to the microbial standard provisions of § 
112.55. We have revised the text throughout § 112.54 to refer to “biol ogical process[es],” and we 
use “composting” as an example of a biological process. Thus, under the revised options for 
treatment processes in § 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 § 
112.55(a) or (b) as “treated” biological soil amendment s of animal origin (provided there is no 
other reason to consider them untreated under § 112.51(b), such as contamination after 
treatment). Th erefore, 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 § 112.54(c)(1) and (2) may be considered “tre ated”  
437 
 provided that they meet the requirements of § 112.54, including satisfying one of the microbial 
standards in § 112.55. On the other hand, raw manure must be regarded as “untreated” under § 
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 § 
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 ca tegory as raw manure with regard to application restrictions in 
§ 112.56.  
 
C. Handling, Convey ing, and Storing Biological Soil Amendments of Animal Origin  (§ 112.52)  
As proposed, § 112.52 would establish requirements for handling, conveying and storing 
soil amendments of animal origin. In  Table 15, we describe the codified provisions of § 112.52 
and any changes we made to those provisions in the final rule.  Comments specific to § 112.52 
follow the table.    
Table 15.-- Description of Revisions to § 112.52  
Proposed 
Provision  Proposed Language  Final Revisions, if Any 
§ 112.52(a)  You must handle, convey, and store any 
biological soil amendment of animal origin in 
a manner and location such that it does not 
become a potential source of contamination to  
covered produce, food -contact surfaces, areas 
used for a covered activity, water sources, and 
water distribution systems  Revised to add other soil amendments and to 
clarify that drip fertigation with agricultural 
teas that are biological soil amendment s of 
animal origin is permitted in compliance with 
other requirements of this rule.   
§ 112.52(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 contamin ated by an 
untreated or in -process biological soil 
amendment of animal origin  No change  
§ 112.52(c)  You must handle, convey, and store any 
biological soil amendment of animal origin 
that has become contaminated as if it was 
untreated  Revised  
  
438 
 (Comment 278) One comment state s that many farms store animal manure purchased 
from animal production facilities for several months before application. The comment maintain s 
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 co vered activity, water 
sources, water distribution systems, and other soil amendments.  
 
(Comment 279) One comment interpret s § 112.52(a) as forbidding drip “fertigation” with 
biological soil amendments of animal origin, even if the material is not reasonab ly likely to 
contact covered produce. The commenter request s 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 reasonab ly be likely to result in contamination 
of covered produce.”  
(Response)  We did not intend for § 112.52(a) to forbid drip fertigation with biological 
soil amendment s of animal origin. Biological soil amendment s of animal origin may be used in 
water distribution systems in accordance with § 112.56 and their status as “treated” or 
“untreated” and, if “treated”, to what standard. If “untreated” or “treated” to the standard in § 
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 § 112.55(a), then there are no restrictions on use. We are  
439 
 revising § 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 th at the proposed language of § 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 § 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 th at you should be required to 
regard as “untreated” under § 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 
amendment s of animal origin that have actual ly become contaminated. This revision makes clear 
that covered farms must regard biological soil amendment s 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 (§ 112.53)  
In § 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  
440 
 provisions of § 112.53 and any changes we made to those provisions in the final rule. Comments 
specific to § 112.53 follow the table.   
Table 16.-- Description of Revisions to § 112.53  
Proposed 
Provision  Proposed Language  Final Revisions, if Any 
§ 112.53  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.  No change  
 
(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 us ed 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 request s 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 protec tive of public health.   
With regard to concerns about ensuring that the provisions are followed for imported 
produce, we note that § 112.53 refers to “equivalent regulatory requirements” to provide for the  
441 
 possibility that other competent authorities have established such require ments 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 th at part 503 is out of date. One comment point s to a National 
Academy of Science s review of part 503, and argue s 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 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 biosol ids 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 wi th 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.   
442 
  
(Comment 283) A comment request s that source separated human urine be classified 
separately from sewage sludge biosolids, thus allowing it to be used i n 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 no t covered by 40 CFR part 503 and, therefore, as human waste, § 
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 use d in growing covered produce, and therefore we are not making this change.  
 
(Comment 284) One comment argue s that even if human sewage has been adequately 
treated to be free of pathogens, it would still be susceptible to recontamination.  This comment 
suggest s 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 t o 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.    
  
443 
 E. Treatmen t Processes (§ 112.54)  
Section § 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 § 112.54 and any changes we made to those provisions in the final 
rule. Comments specific to § 112.54 follow the table.   
Table 17.-- Description of Revisions to § 112.54  
Proposed 
Provision  Proposed Language  Final Revisions, if Any 
§ 112.54  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, providing that the resulting 
biological soil amendments are applied in 
accordance with the applicable requirements of 
§ 122.56:  No change  
§ 112.54(a)  A scientifically valid controlled physical 
process (e.g., thermal), chemical process (e.g., 
high alkaline pH), or combination of 
scientifically valid controlled physical and 
chemical processes that have been 
demonstrated to satisfy the microbial standard 
in § 112.55(a) for L. monocytogenes , 
Salmonella  spp., and E. coli O157:H7;  Revised to add biological processes and replace 
“demonstrated” with “validated .”  
§ 112.54(b)  A scientifically valid controlled physical 
process, chemical process, or comb ination of 
scientifically valid controlled physical and 
chemical processes, that has been demonstrated 
to satisfy the microbial standard in § 112.55(b) 
for Salmonella  and fecal coliforms; or  Revised to add biological processes and replace 
“demonstrated” with “validated .”  
§ 112.54(c)  A scientifically valid controlled composting 
process that has been demonstrated to satisfy 
the microbial standard in § 112.55(b) for 
Salmonella  and fecal coliforms.  Scientifically 
valid controlled composting processes includ e: First sentence eliminated because biological 
processes meeting the § 112.55(b) standard are 
now included in revised § 112.54(b). Second 
sentence is now part of § 112.54(b) and has been 
revised to refer again to the microbial standard 
in § 112.55(b).  
§ 
112.54(c)(1)  Static composting that maintains aerobic (i.e., 
oxygenated) conditions at a minimum of 131 
°F (55 °C) for 3 days and is followed by 
adequate curing, which includes proper 
insulation;  Renumbered to § 112.54(b)(1) as a conforming 
change to the c ombination of § 112.54(b) and 
(c); clarified that “3 days” is consecutive ; and 
deleted “which includes proper insulation”  as it 
is covered by adequate curing  
§ 
112.54(c)(2)  Turned composting that maintains aerobic 
conditions at a minimum of 131 °F (55 °C)  for 
15 days, with a minimum of five turnings, and 
is followed by adequate curing, which includes 
proper insulation; or  Renumbered to § 112.54(b)(2) as a conforming 
change to the combination of § 112.54(b) and 
(c); revised to state  that “15 days” does not have 
to be consecutive ; deleted “which includes 
proper insulation” as it is covered by adequate 
curing; and deleted “or” at end because § 
112.54(c)(3) is deleted.  
§ Other scientifically valid, controlled Eliminated as not necessary.  All scientifically  
444 
 112.54(c)(3)  composting processes, provided you sat isfy the 
requirements of § 112.12, including that the 
alternative has been demonstrated to satisfy the 
microbial standard in § 112.55(b).  valid, controlled biological treatment processes, 
including composting , that meet the microbial 
standards of § 112.55 are allowable under 
revised § 112.54(a) and (b), making the 
allowance for alternative processes unnecessary.   
 
(Comment 285) Some comments state s that the rule inappropriately treats use of 
physically and chemically treated soil amendments as less risky than soil amendments treated by 
composting.   One comment propose s 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 § 112 .54(b)(1) and (b)(2); and 2) has been demonstrated to 
satisfy the microbial standard in § 112.55(a).  
(Response)  FDA agrees that flexibility ne eds to be added to the provisions of § 112.54 to 
broaden the allowable methods for producing stabilized compost that may be regarded as 
“treated” under § 112.51 and also to allow farms to regard as “treated” biological soil 
amendment s of animal origin proc essed using biological processes other than composting, such 
as vermicomposting, provided that such processes meet the microbial standards in either § 
112.55(a) or (b). We also recognize that the structure of proposed § 112.54 should be revised to 
better r eflect the application requirements in § 112.56, which we proposed to change in our 
supplemental notice without making conforming changes to § 112.54. Thus, we are adding 
options for biological treatment processes (including, but not limited to, composting ) in § 
112.54(a); and collapsing § 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 § 1 12.55(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 § 112.55(a) or (b), we  
445 
 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 § 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 val id” 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 scientifi cally valid and controlled and has been 
demonstrated (i.e., validated) to meet the applicable microbial standards of § 112.55. A treatment 
process that has been demonstrated to satisfy the microbial standards of § 112.55 has been 
validated to meet those mi crobial standards. Therefore, because this comment suggested that 
there may be some confusion on this, we are revising §§ 112.54(a) and (b) to replace the word 
“demonstrated” with the word “validated.” We note that consistent with language in other 
regulat ions ( 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 b ooks, or proprietary 
research.   
446 
  
(Comment 287) A comment requests that FDA add the following language to §  112.54 
“…provided that the resulting biological soil amendments meet the microbial standards for the 
treatment processes as stated in §  112.55 and are applied in accordance with the applicable 
requirements of §  112.56...”  
(Response)  It is not necessary to add this language to the introductory text of § 112.54 as 
the requirements to meet the microbial standards in § 112.55(a) or (b) are contained within t he 
provisions of § 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 §  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 t echniques that include timing and location parameters, to 
establish that the appropriate microbial results stated in the proposed §  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 valida ted. Proper 
validation to show that a process satisfies the microbial standards of § 112 .55 needs to include 
specific process variables, and the person applying the treatment process will need to monitor the  
447 
 physical parameters of the process (e.g., the te mperature 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 suggest s 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 urge s FDA to issue a regulation specifically for the use of 
manure from animal production facilities. The comment states that FDA should require animal 
production faci lities 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 a re 
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  
448 
 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 note s that 
if an agricultural tea is prepared from a stabilized compost feedstock that meets the 
microbiological standard of §  112.55(b), then the remaining populations of these microorganisms 
have the potential to experience rapid population growth. The commen ter also note s that the 
microbiological criterion set in §  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 othe r biological soil amendment s 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 § 112.51, the components used to make  the tea be 
treated via a process described in § 112.54 (a) or (b) to meet the microbial standards of § 
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.” Agricultura l 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 § 112.51(a) , must be considered “untreated” for purposes of § 112.51. With 
regard to the pot ential rapid growth of pathogens in agricultural teas that meet the microbial 
standards of § 112.55, we note that agricultural teas cannot contain agricultural tea additives if 
they are to be considered “treated” for purposes of § 112.51, which are the pri mary contributing 
factor to rapid growth of microflora in teas  (Ref. 174) . Finally, we agree that the proposed 
microbial standards in § 112.55 were established on a dry weight basis, which would not be 
appropriate for agricultural teas. Therefore, we have modified § 112.55 to add a liquid weight 
basis for sampling (for use in validation).     
449 
  
(Comment 292) At least one comment suggest s 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 saf ety 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 woul d have a zero day application interval (see discussion in 79 FR 58434 ). 
We are finalizing the provision in § 112.56 for a zero -day interval for stabilized compost.  
Depending on the microbial standards that the stabilized compost meets (§ 112.55(a) or (b)),  the 
allowable application methods differ (compare § 112.56(a)( 3) and (a)( 2)).  
 
(Comment 293) A comment request s 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 farm s ensure adequate pathogen reduction in stabilized compost, prior 
to field applica tion. 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 sufficie nt 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 expre ss 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  
450 
 compost curing process). These comments suggest suc h use of insulation would be neither 
economically feasible nor operationally practical. Another commenter suggest s that the specific 
requirements for use of insulating material on compost piles during the curing process are 
impractical for small -farm metho ds of composting. Some comments indicate  that the proposed 
requirement for insulated curing of compost in §  112.54 (b)(1) and (b)(2) (originally proposed as 
§ 112.54(c)(1) and (c)(2)) is overly burdensome and not necessary for all approaches to the 
compost ing 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 § 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 tem perature (for example, 131  °F (55 °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 m ay 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 gradu al 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 cha nges, 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.   
451 
 We also acknowledge that, for static composting, insulation may also b e 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 previou sly, curing may or may not involve insulation. W e are removing the 
requirements for proper insulation in §  112.54(b)(1) and (b)(2) because these provisions are  
examples of scientifically valid controlled biological (e.g., composting) processes that meet th e 
microbial standard in § 112.55(b) . We agree that insulation may not be necessary to meet the 
microbial standard of § 112.55(b) under all circumstances  and so we have removed the reference 
to insulation in § 112.54(b)(1) and (b)(2). However, those employi ng the static and turned 
composting processes described in § 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 request s 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 “tr eated” for purposes of § 112.51 and associated application restrictions in § 
112.56. The commenter suggest s 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 untre ated biological 
soil amendment s of animal origin.   
452 
 (Response)  Processes that meet the requirements of § 112.54 must be scientifically valid, 
controlled processes that have been validated to meet the microbial standards in either § 
112.55(a) or (b).  We are n ot 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 § 112.55(a) or (b).  
 
(Comment 295) One comment ask s for a revision to the example process provided for 
“turned composting” in § 112.54(b)(2) (originally proposed as § 112.54(c)(2)) to read, 
“Composting that maintains a minimum average temperature of 131 °F (55 °C) or higher for 15 
days or longer and is followed by adequate c uring, storage and handling practices. During the 
period when the compost is maintained at 131 °F (55 °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 °F (55 °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 § 112.54(b)(2) suggested by the comment er. 
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 b e continuous.   
With respect to storage and handling, the rule already covers these topics sufficiently in § 
112.52, and those requirements apply equally to all processes used under the rule, including 
those described in § 112.54(b)(2).    
453 
 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 § 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 windrow s will reach 55  °C relatively quickly, at which time the 
operator will begin monitoring the ‘degree days’ above this temperature  towar d meeting the 
fifteen days of exposure to 55 °C  per §  112.54(b)(2). T o continue this ‘thermophilic phase’ of th e 
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 °C temperature for a total of  
15 days to rely on the option in § 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 °C 
temperature, to rely on the option in § 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 siz e, shape 
and feedstock composition. It is our understanding that, in order to maintain a compost 
temperature  of at least 55  °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 , § 112.54(b)(1) and (b)(2) provide two 
example processes that farms may use to satisfy the microbial standard in § 112.55(b), but these 
are not the only means of achieving adequate composting to meet the microbial standard in § 
112.55(b). Thus, we do not discourage farms from using processes that allow a minimum of 3 
days between turnings if tho se processes are validated to meet the microbial standards in §  
454 
 112.55(a) or (b), but we are not revising our example process in § 112.54(b)(2) because we do 
not believe it is necessary.   
With respect to the commenter’s sug gestion that the 15 days need n ot be continuous, we 
agree that the 15 days at 55 °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 § 
112.54(b)(2) to indicate that the 15 days at 55 °C need not be consecutive . For clarity , we are 
also revising § 112.54(b)(1) to indicate that the 3 days at 55 °C is consecutive . For static aerated 
composting, 3 consecutive days at or above 55 °C ensures that the microbial standard in § 
112.55(b) is achieved, consideri ng the expected die -off rates of various classes of thermophilic 
and thermotolerant pathogens  (Ref. 180 ).  
 
(Comment 296) One comment ask s for confirmation that covered produce grown using 
biological soil amendments of animal origin containing pathogens at or below the microbial 
standards set forth in § 112.55(a) and (b) are considered “safe.”  
(Response)  In this regulation, FDA is establishi ng 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 reasonab le 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 recommend s that rather than fo cusing on process 
standards, which the commenter criticize s as ambiguous, the rule should instead require that  
455 
 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 § 112.54) that has been validated to s atisfy 
the microbial standards of either § 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 additio n, 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 § 112.55 are protective of public health. Treatments for biological soil 
amendments of animal origin must be scientifically valid, controlled processes that have bee n 
validated to satisfy the relevant microbial standard in § 112.55(a) or (b). In § 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 § 112.55(b) for Salmonella a nd fecal coliforms when done 
properly.   
  
456 
 (Comment 299) Some c omments 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. This 
rule does not require covered farms to receive such guara ntees 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 § 112.54  (§ 112.55)  
Section 112.55 establishes microbial standards applicable to the treatment processes in § 
112.54. In  Table 18, we describe th e codified provisions of § 112.55 and any changes we made 
to those provisions in the final rule. Comments specific to § 112.55 follow the table.  
Table 18.-- Description of Revisions to § 112.55  
Proposed 
Provision  Proposed Language  Final Revisions, if Any 
§ 112.55  The following microbial standards 
apply to the treatment processes in § 
112.54 as set forth in that section.  No change  
§ 112.55(a)  For L. monocytogenes , Salmonella  
species, and E. coli O157:H7, the 
relevant standards [are those in (a)(1) - 
(a)(3)] or;  No change  
§ 112.55(a)(1)  L. monocytogenes ... Not  detected  
using  a method  that can detect  one 
colony  forming  unit (CFU)  per 5 
gram analytical portion.  Revised to add liquid sampling . 
§ 112.55(a)(2)   
Salmonella  species... Less than three 
most probable numbers (MPN) per 4 
grams of total solids (dry weight basis)  Revised to add liquid sampling and indicate that it is a 
‘non-detect’ standard .  
§ 112.55(a)(3)  E. coli O157:H7… Less than 0.3 
MPN per 1 gram analytical  portion.  Revised to add liquid sampling and indicate that it is a 
‘non-detect’ standard .  
§ 112.55(b)  Less than three MPN Salmonella  Revised to add liquid sampling and indicate that the  
457 
 species per four grams of total solids 
(dry weight basis); and less than 1,000 
MPN fecal coliforms per gram of total 
solids (dry weight basis).   Salmonella  method is a ‘non -detect’ standard .  
 
(Comment 300) One comment suggest s that should FDA consider end -use risk in 
establishing final microbial standards for treated biological soil amendment s of animal origin. 
The comment pointed to Austrian ÖNORM 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 amend ment s 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. T he end uses to which the requirements of subpart F apply are more limited than those 
in the Austrian stand ards noted in the comment. Second, we conclude that all treated biological 
soil amendments of animal origin must meet the standards in § 112.55(a) or (b), and those that 
meet the standards of § 112.55(b) must also be applied in accordance with the restrict ions in § 
112.56(a)( 2). We also conclude that untreated biological soil amendments of animal origin must 
be applied in accordance with the restrictions in § 112.56(a)(1). See Comment 257  regarding our 
plans for application intervals for such biological soi l amendment s of animal origin.  
 
(Comment 301) Some comments indicate a belief that the standards in proposed § 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 the y meet the relevant microbial standards. Rather, we have 
provided the microbial standards against which treatment processes must be validated. Proper  
458 
 validation to show that a process s atisfies the microbial standards of §  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 mee t 
the conditions under which the process was validated. See also our response to  Comment 286 . In 
§§ 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 § 112. 55(b) for Salmonella  and fecal 
coliforms when done properly.    
 
(Comment 302) One comment recommend s FDA change the microbial standards for 
Salmonella  spp. and E. coli O157:H7 in § 112 .55(a) to “negative” or less than detect able limit 
(<1/30 grams).  
(Response)  The microbial standards as proposed in §  112.55(a) represented “less than the 
detectable limit” for each pathogen, though only §  112.55(a)(1) was phrased as “not detected 
using a method that can detect...” We are revising the standards in §§ 112 .55(a)(2) and (a)(3) and 
the Salmonella standard in 112.55(b) to provide a parallel structure. As revised, §  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  (§ 112.56)  
Section 112.56 establishes application restrictions based on whether biological soil 
amendment s of animal origin are treated or untreated; and for those biological soil amendment s 
of animal origin that are treated, based on the level of treatment they received (with reference to 
the microbial standards in § 112.55). In Table 19, we describe the proposed codified provisions 
of § 112.56 (considering the 2013 proposed rule and the su pplemental notice, taken together) and  
459 
 any changes we made to those provisions in the final rule. Comments specific to § 112.56 follow 
the table s. 
Table 19.-- Description of Revisions to § 112.56 (a) 
Proposed 
Provision  Proposed Language  Final Revisions, if Any 
§ 112.56(a)  Except as provided in paragraph (b) of 
this section, you must apply the 
biological soil amendments of animal 
origin specified in the first column of 
the table in this paragraph in 
accordance with the application 
require ments 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)]. Deleted “Except as provided in paragraph (b) of this 
section” as a conforming change to the deletion of (b) 
(made in the supplemental notice ). 
 
Revised (a)(1) -(4) to (a) (1)-(3)  
 
 Proposed §  112.56(a)(1) -(4) was published at 78 FR 3504 , January 16, 2013 . 
 Final §  112.56(a)(1) -(3) is set forth in the regulatory text of this rule . 
 
The revisions in final  § 112.56(a)(1) -(3) consist of conforming amendments to match 
changes made in §  112.54 (including biological processes in both § 112.54(a) and (b), and 
collapsing § 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 
commen t 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  
460 
 underground crops would be considered to come into contact with the biological soil 
amendment s of animal origin used on the soil.    
(Response)  FDA intends “does not contact” in § 112.56 to mean there is no intended or 
likely contact between the biological s oil 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 § 112.56. However, we 
intend to include consideration of wind -blown contamina tion 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 a nd 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 intend ed, 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  
461 
 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 int ended 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 § 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 al ways 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 farm s to consider use of stabilized compost as 
an alternative to raw manure.   
 
H. Records Relat ed to Biological Soil Amendments of Animal Origin (§ 112.60)   
462 
 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 § 112.60 and any changes we made to those 
provisions in the final rule.  Comments specific to § 112.60 follow the table.  
 
Table 20.-- Description of Revisions to § 112.60  
Proposed 
Provision  Proposed Language  Final Revisions, if Any 
§ 112.60(a)  You must establish and keep records required under this 
subpart F in accordance with the requirements of subpart 
O of this part  No change  
§ 112.60(b)  For any biological soil amendment of animal origin you 
use, you must  establish and keep the following records:  No change  
§ 112.60(b)(1)  For a treated biological soil amendment of animal origin 
you receive from a third party, documentation (such as a 
Certificate of Conformance) that:  
(i) The process used to treat the biolo gical 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 § 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  
 Revision to eliminate proposed (1)(ii) 
and as a conforming change to 
renumber (1)(iii) to (1)(ii)  and to 
require such documentation at least 
annually .  
§ 112.60(b)(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  No change  
§ 112.60(b)(3)  Scientific data or information you rely on to support a 
process used to treat a biological soil amendment of 
animal origin in accordance with the requirements of § 
112.54(c)(3).  
 Elimination of § 112.60(b)(3) as a 
conforming change since § 
112.54(c)(3) has been deleted  
 
(Comment 305) One comment request s clarification on what compost suppliers should 
document to ensure covered farms could rely on such documentation to satisfy the rule and on  
463 
 documentation needed when using alternative composting procedures.  Another comment ask s us 
to clarify the requireme nts 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 requirement s. We are sensitive to 
requests t hat we minimize the burden of testing. Therefore, we are eliminating proposed § 
112.60 (b)(1)(ii) that would have required documentation of testing of treated biological soil 
amendment s of animal origin received from third parties to verify that the treatme nt process 
satisfies the applicable microbial standard in § 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 documentati on of such testing performed by their  
supplier s. We are requiring in § 112.60(b)(1)(i) that , with respect to treated biological soil 
amendment s of animal origin received from a third party, cover ed 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 § 112.60 (b)(1)(iii) to § 
112.60 (b)(1)(ii) and maintaining the requirement, as proposed, that  with respect to treated 
biological soil amendment s of animal origin rece ived 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 biolo gical 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 § 112.60(b)(2) a farm must have  
464 
 documentation that process controls (for example,  time, temperature and turnings) were 
achieved. As a conforming change to the elimination of § 112.54(c)(3), we are eliminating 
proposed § 112.60(b)(3) which would have required records documenting the scientific data or 
information relied on to support an y alternative composting process used to treat biological soil 
amendment s of animal origin in accordance with § 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 § 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 § 112.60(b)(1); 
it need not be named a “Certificate of Conformance.” We disagr ee 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 a t least annually. We are adding the annual requirement to 
the codified in § 112.60(b)(1).   
  
465 
 (Comment 307) Some comments suggest that, in order to best protect consumers from the 
risk of pathogens, FDA should require adequate recordkeeping for application i ntervals 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 § 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 amen dments 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 state s that FDA should require farms to docu ment 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.   
466 
  
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 § 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 comm ents 
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 § 112.55(a), it would still be considered a 
“treated” biological soil amendment  after use for growing mu shrooms 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 th at if a substrate 
such as spent mushroom mulch previously met the requirements to be considered a “treated” 
biological soil amendment of animal origin under § 112.51, then it retains that status after use as 
a growth media, unless you know or have reason t o believe it has been otherwise contaminated 
with a hazard or has been associated with foodborne illness.    
467 
 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 conclusi on 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, taki ng into account comments on the 2013 
proposed rule, we proposed § 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 § 112.84 (79 FR 58434 a t 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 di scuss 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 discu ss comments received on  
proposed § 112.84 in the supplemental  notice  in section  III.E of this document .  
468 
 We are finalizing these provisions with revisions (s ee 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 Rule and 
Amended in the 
Supplemental Notice)  Final Provision  Description of Revisions  
§ 112.81  § 112.81  - Revision to § 112.81(b) to state that subpart I does not apply to fish 
used in aquaculture operations  
§ 112.82  § 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 prev ent 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 § 112.8 3 applies during the growing 
season, in contrast to the related § 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 § 
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 neces sary 
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  
§ 112.83  -  
§ 112.84  § 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 addressin g the potential for contamination of covered produce by domesticated or wild 
animals. Produce that receives commercial processing that adequately reduce s the presence of  
469 
 microorganisms of public health significance is eligible for exemption from this rule with certain 
documentation under § 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 § 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 antimicr obial 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 (§ 112.81)  
(Comment 311) Several comments support limit ing 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 tha t 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.   
470 
 (Response)  We are maintaining the limitation on applicability of subpart I to outdoor 
areas and partially -enclosed buildings, as proposed. We are not expanding t he 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 ac knowledge 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, me asures directed at domesticated animals in a fully -enclosed building are 
described under § 112.127, and requirements regarding pest control in both fully -enclosed and 
partially -enclosed buildings are described under § 112.128. We have also revised § 112.18 1(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 cov ered 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, an d 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 s uch 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 § 112.112 and §  
471 
 112.83 to make explicit when and how these provisions apply and how they differ from each 
other, clarifying that § 112.112 applies immediately prior to and du ring harvest, while § 112.83 
applies during the growing season. The requirement in § 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 contamina ted 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 (§ 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 pr oduce 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 covere d 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  
472 
 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 (§ 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 commodit ies 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 gro wn 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, exp osing 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 contamina tion during 
the growing season as a general matter that warrants application of the additional requirements in 
§ 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 § 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  
473 
 various pat hways. Thus, we conclude that it is warranted to apply § 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 typicall y 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 suc h 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 (§ 112.83)  
(Comment 314) Some comments request that FDA clar ify what would be considered an 
adequate  waiting period under proposed § 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  
474 
 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 § 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 § 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 § 112.83 relating to wildlife, could be used to satisfy the requirements of proposed § 
112.82(b) for working animals. Seve ral 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 § 112.82(b). For example, some comments suggest that § 112.82(b) may 
limit the use of wo rking 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. S ome 
comments express concerns about whether proposed § 112.82(b) would prevent covered farms 
from using dogs, cats, or chickens to deter pests in growing areas; or prevent farms from using 
guard dogs to keep other animals out of fields.  
(Response)  We are r emoving § 112.82 from the rule and replacing it with revised 
requirements related to grazing and working animals in § 112.83, discussed further in the 
paragraphs that follow . FDA continues to believe that an adequate waiting period between 
grazing and harv est is an important consideration when, under the circumstances, there is a 
reasonable probability that grazing animals will contaminate covered produce. As discussed in  
475 
 the 2013 proposed rule and our QAR, domesticated animals can be a source of human path ogens. 
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 gene rally more likely to 
harbor zoonotic pathogens than are wild animals (Ref. 18 6). 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 prod uce (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 farmin g 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 
elimin ating the proposed requirement for an adequate waiting period between grazing and 
harvesting in proposed § 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 § 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,  
476 
 scientifically sound, and simpler than establishing diffe rent 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 § 112.82(a)) and 
measures to prevent introducti on of hazards from working animals into or onto covered produce 
(proposed § 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. Un der revised § 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 (§ 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) ( § 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 covere d produce can be harvested in accordance with the requirements of § 
112.112, and you must take measures reasonably necessary during growing to assist you later 
during harvest when under § 112.112 you must identify, and not harvest, covered produce that is 
reasonably likely to be contaminated with a known or reasonably foreseeable hazard (§ 
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 co nsumption, 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  
477 
 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 anim als, 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 harve sted in 
accordance with § 112.112, § 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 § 
112.112. For example, if you have identified an area with signifi cant 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 occurre nces 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 u se 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 rotatio n systems) and farms that rely on working animals for various purposes, 
including horses, dogs, cats, and chickens. Under revised § 112.83, farms would be required to 
apply the same approach to any of these uses of animals, and only if under the circumstan ces  
478 
 there is a reasonable probability that animals will contaminate covered produce (§ 112.83(a)).  
Farms in such circumstances must assess the relevant areas as needed during the growing season 
(§ 112.83(b)(1)), and if evidence of potential contamination i s 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 (§ 112.83(b)(2)). We 
also note that § 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 § 112.83. We will consider providing guidance on 
issues related  to integrated or 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 reasona ble 
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 cove red 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 eva luate 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  
479 
 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 (§ 112.83). We believe this rule requires an appropriate l evel 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 § 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 requiremen t for farms to exclude wildlife from areas where covered 
produce is grown.  
(Response)  We are eliminating proposed § 112.82(a) for the reasons discussed in 
response to Comment 314. In addition, to remove any possible confusion, FDA has added § 
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 reg ulation does not 
require termination of the use of working animals on covered farms. As discussed in response to  
480 
 Comment 314 , we are revising requirements related to working animals, now established in § 
112.83. Revised § 112.83 does not prohibit the use o f working animals on covered farms. 
Therefore, covered farms can use working animals provided that the farm complies with § 
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 th e comment did not provide information from which we could conclude that 
such vaccines are available.    
 
D. Animal Intrusion (§ 112.83)  
(Comment 319) In response to the 2013 proposed rule, several comments express support 
for the monitoring requirement in p roposed § 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 § 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 farm s 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 contami nated or adulterated. Some comments suggest  
481 
 FDA should use an “outcome -based approach” to animal intrusion, and suggest that monitoring 
of crop during harvest as set out in § 112.112 is the most appropriate control point at which to 
ensure contaminated pro duce is excluded. These comments appear to argue that monitoring as 
required by proposed § 112.83, during the growing season and immediately prior to harvest, is 
unnecessary in light of the requirements of § 112.112 that apply immediately prior to and duri ng 
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 d eposition 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 assessm ent 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 pri or to and during harvesting in § 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 § 112.83(b)(1)). We do not expect the 
requirements of § 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, 
§ 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  
482 
 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, §§ 112.83 and 112.112 are 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 § 112.83 to apply to grazing animals, working 
animals, and animal intrusion.  We have deleted requirements from proposed § 112.83 that 
would have applied “immediately prior to harvest” and limited its application to “during the 
growing season.” By contrast, § 112.112 is a generally applicable requirement that applies 
immediately pr ior to and during harvest activities. We are revising both §§ 112.83 and 112.112 
to make this distinction clear. We believe that § 112.83 adds an important level of public health 
protection beyond the general harvest -related requirement in § 112.112, and t hat the additional 
requirements of § 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 circumstanc es, 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 (§ 112.112). In these 
situations, covered farms must take proa ctive steps under § 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  
483 
 significant cro p destruction), § 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 th at 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 a n 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 awa y 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 o f 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 conclu de that assessing for evidence of potential contamination and taking 
appropriate follow -up actions, as described in § 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 § 112.83.    
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(Comment 320) Some comments request t hat any requirem ents for record keeping 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 e stablishing 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 anim als 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 § 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, § 112.42( c) requires covered farms to 
adequately maintain all agricultural water sources that are under the farm’s control (s uch 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 circumstance s.  
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(Comment 322) One comment requests that FDA define more specifically the time period 
that would be appropriate for fulfilling the proposed requirement in proposed § 112.83(a)(2) to 
monitor for animal intrusion “immediately prior to harvest.”  
(Response ) We are eliminating th e phrase “immediately prior to harvest” in § 112.83.  As 
described  in response to Comment 314, revised § 112.83 applies during the growing season. We 
are, however, retaining similar language in § 112.112. As discussed in  section XVI.B of this 
document, we use “immediately prior to harvest” in § 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 intr usion 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 req uirements.  
  
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 (Comment 324) Some comments argue that the requirements of proposed § 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.  
(Respon se) As discussed in section XVI of this document, we have revised § 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 cove red 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 th at 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 animal s, 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  
487 
 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 si gnificant quantities of animals, significant amounts of animal excreta, or significant 
crop destruction), § 112.83(b)(2) requires covered farms to evaluate whether covered produce 
can be harvested. This evaluation described in § 112.83(b)(2) is the same ty pe of evaluation 
described in § 112.112, but under § 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 farm s should be required to evaluate 
whether their covered produce can be harvested in accordance with § 112.112 upon finding any 
evidence of animal intrusion; suggesting that the phrase “significant quantities of” in proposed § 
112.83(b) should be removed.  
(Resp onse)  We disagree. As noted previously , we do not expect the requirements of § 
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 § 112.83 are intended to provide you with 
information about animal mo vements 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 § 112.112  
provides sufficient protection to address less than significant animal intrusion ( i.e., intrusion that  
488 
 occurs without the farm observing, during required assessment, significant quantities of animals, 
significant animal excreta, or significant crop destru ction).  
 
(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 shou ld 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 requ irements of § 112.83 and related § 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 covere d 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 contaminati on 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 guid ance, which we expect to issue in the near term. We agree  
489 
 that the practices suggested by the commenters may be appropriate strategies for compliance 
with § 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 han d 
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 harv esting.  
(Response)  As discussed in section XVI of this document, we have revised § 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 r easonably 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 § 112.112 
to address the differences between hand harvesting and machine harvesting with respect to the 
ability to detect evidence of potential contamination. We have also revised § 112.83 to specify 
that it applies only during the growing season and not during or immediately prior to harvest.  
490 
 Thus, we do not consider it to be necessary to take into account harvesting practices in § 112.83 
because we consider that they are sufficiently addressed in § 112.112.  
 
(Comment 328) Several comments express concern that proposed § 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 pr oducers 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 inten ded to improve water quality, protect endangered species, and 
enhance wildlife habitat.  
(Response)  We believe that these concerns have been addressed through our addition of § 
112.84, as discussed in the supplemental notice.  
 
E. List of “ Animals of Conce rn” 
(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 farm s 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.   
491 
 (Respo nse) 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.”  
 
  
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 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. W e asked for comment 
on our proposed provisions, including proposed § 112.114 related to dropped produce; and 
proposed § 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  
§ 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 distri bution, such as in 
gift baskets.   
§ 112.112  - Revision to clarify that § 112.112 applies during 
and immediately prior to harvest, in contrast to the 
related § 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, regard less of the harvest method used”  
§ 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 pra cticable  
§ 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  
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 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 § 112.2(b)” 
as confusing and unnecessary  
§ 112.115  - No change  
§ 112.116  - Revision to § 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 § 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 (§ 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 cr oss-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 not grown, harvested, packed or held in accordance with part 
112) during growing, harvesting, packing, and holding as applicable, to avoid phy sical 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  
494 
 believe the common meaning of this term to be suf ficiently 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 § 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 § 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 cover ed 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. Harvest ing Covered Produce (§ 112.112)  
(Comment 331) Some comments cite specific circumstances where contamination is 
likely and request clarification regarding applicable requirements under § 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 § 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  
495 
 may not have been identified or removed. Anoth er 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 § 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 § 112.112 to 
clarify when and how this provision applies, and to distinguish it from the related § 112.83.  See 
our discussion of § 112.83 in section XV of this document . Section  112.112 applies 
immediately prior to and during harvest, while § 112.83 applies during the growing season. 
Section 112.112 applies generally to covered farms with respect to all covered produce, while § 
112.83 only applies when under the circumstances there i s 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 § 112.83 applies only when the reasonably likely source of 
contamination is animal activity.  
Within § 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 § 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 § 112.112 that identifying and not harvesting 
covered produce that is reasonably likely to be contaminated with animal excreta or that is  
496 
 visibly contaminated wi th 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 
harves ting 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 visibl e 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 harves ting 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 c arrots 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 § 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 choo se 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 
harvest ing 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  
497 
 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 § 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 agricultu ral water must be safe and of adequate sanitary quality for its 
intended use ( § 112.41) . Subpart E provides the relevant requirements for what farms must do 
when agricultural water does not meet this standard ( § 112.4 5(a)), or other specific microbial 
quality criteria  we are establishing for certain uses ( §§ 112.4 5(a) and ( b)), and therefore, we do 
not believe additional standards are needed under § 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 therefore not subject to the requirements in subpart E. However, both §§ 112.11 and  
112.112 apply to flooding situations. In accordance with § 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 unde r 
section 402 of the FD&C Act on account of such hazards. Moreover, in accordance with § 
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  
498 
 known or reasonably foreseeable hazards through contact with flood water.  
 
(Comment 332) One commenter suggests revising § 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 § 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 mus t not be harvested. Accordingly, § 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 spec ifies, 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 Covere d Produce (§ 112.113)  
(Comment 333) One commenter recommends that we include the following types of 
explicit and specific requirements in § 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  
499 
 that many produce commodities cut during harvest grow near or in contact with the soil, the 
commenter questions the feasi bility of the example provided in § 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 commodit ies 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 § 112.113, we agree that 
adding the phrase “to the degree practicable” i s 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, § 
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 
practicab le. 
Accordingly, we are revising § 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  
500 
 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. 1 82) 
(Ref. 183 ). Bacteria may find harborage and protection on plants through hydrophobic areas, 
stomata, lenticels, punctures, and bruises and where it  is not readily wash ed 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 h elp 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 
cove red 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  
501 
 are not establishing a requirement for microbiological product testing of covered pro duce, 
except as established in subpart M under certain circumstances for sprouts ( § 112.144(b) and 
(c)). See section III.F of this document.  
 
D. Dropped Covered Produce (§ 112.114)  
In § 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 § 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 gr ound. 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 § 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 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  
502 
 recognize the importance of tailoring your food safety practices t o 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 con sistent with and do not violate the requirements of 
this rule, including § 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 § 112.114 in a manner that excludes p roduce that is 
intentionally dropped as part of harvesting (i.e., produce that drops to the ground before   
503 
 harvest). Taking this into account and in light of other comments (see  our response to 
Comment 338 ) we are revising § 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 § 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 r ates 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 cantal oupes  (Ref. 19 4) (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 wa y that 
minimizes the potential for any surface contamination to come in contact with the edible  
504 
 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 § 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 laye r 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 
counterac t these concerns as a general matter.  
 
(Comment 338) Several comments note that proposed § 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 § 112.114 unless it is 
specifically identified as not being included within the meaning of “dropped covered produce.” 
Under revised § 112.114, dropped covered produ ce 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).  
505 
 However, produce that gro ws 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 § 
112.114 unless it is otherwise excluded ( e.g., if dropping is an inte ntional 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 co nsider 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 p ersonal consumption, for commercial processing, or for food for animals.  
(Response)  We are removing the reference to produce that is exempt under § 112.2(b) 
from the codified text of this section. We are making this change because produce that is 
exempt f rom the requirements of part 112 under § 112.2(b) is exempt from all the requirements 
in part 112 except those specified in § 112.2(b). We are concerned that including a specific 
reference to exempt produce in § 112.114 might have misleadingly and incorrec tly suggested 
that produce that is not covered by part 112 (under § 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 § 112.2(b), because it receives commercial processing that adequately  
506 
 reduce s the presence of microorganisms of public health significance), is subject to certain 
requirements other than as specified in § 112.2. In fact, neither produce that is not covered by 
part 112 (under § 112.2(a)), or produce that is exempt from part 112 (under § 112.2(b)) is 
subject to § 112.114.   
 
E. Packaging Covered Produce (§ 112.115)  
(Comment 340) Several comments generally su pport 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 r esearch 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 ensu re appropriate packaging.  
(Response)  The provision in § 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 th e 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 packa ged 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  
507 
 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). Therefo re, 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 § 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 § 112.116 and applies 
specifically to the hazard of formation of C. botulinum  toxin. Whereas § 112.116 is aimed at 
ensuring that packing materials themselves do not intro duce hazards into produce, § 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  
508 
 for toxin formation. For example, perforated packaging film allows free air access and is a mean s 
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 comp ounds.   
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 § 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 manufact uring/processing is irradiation . 
However, § 112.115 applies to packaging that does not include additional 
manufacturing/processing ; such packaging includ es modified atmosphere packaging and other 
methods of packaging of covered produce in a manner that cre ates 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 def inition and is, therefore, subject to this rule and to § 
112.115.  
Accordingly, we are finalizing § 112.115, as proposed, with no changes.  
  
509 
 F. Food-Packing ( Including Food Packaging) Material (§ 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 § 112.116(a). For 
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 bi ns or boxes, and 
canvas bags that are used during harvest also must meet the requirement in § 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 a dequate 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 § 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  
510 
 containers and other porous materials during harvesting. Several other commenters point out 
requiring farms to switch to plastic containers would cause significant economic bu rden 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 (§ 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 con tainers  or use a clean liner on the food packing container to protect produce from 
contamination (§ 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 cir cumstances. 
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 a nd adequate cleaning cannot be achieved.  
  
511 
 (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 § 112.116(b) to the extent it may require sanitizing food 
containers. One such comment states that it is not feasible for far mers 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 § 112.116(a), you must use food -packing material that is adequate for its intended 
use and, per § 112.116(b), if you re -use a food packing container, you must take measures to 
ensure that the food -conta ct surfaces of that container are clean. We recognize the use of 
“sanitizing” in the example we provided within proposed § 112.116(b) (i.e., “such as by 
cleaning and sanitizing, when necessary, food -packing containers”) is confusing and implies a 
requireme nt 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 § 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 § 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 - 
512 
 contact surfaces for covered activities on covered produce. For example, if you use food 
packing containers tha t 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.   
513 
 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 fore seeable 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  
§ 112.121  - Revisions to delete the term “other 
contamination”, and replace “undesirable 
microorganisms” with “microorganisms of public 
health significance”  
§ 112.123(d)  - Revision to move “when necessary and 
appropriate” before “sanitize” to clarify 
applicability  
§ 112.124  - Revisions to delete the term “other 
contamination”, and replace “undesirable 
microorganisms” with “microorganisms of public 
health significance”  
§ 112.126  - Revision to eliminate proposed § 112.126(a)(3) 
and, instead, establish new provision § 112.126(b) 
requiring measures to pr event 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  
§ 112.129  - Revision to clarify the required  frequency of 
servicing and cleaning toilet facilities  
§ 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 rub s” in 
lieu of “hand antiseptic /sanitizer or wipes ” 
- Revision  to permit the use of “other effective 
surfactants ” in lieu of soap  
§ 112.140  - No change  
 
  
514 
 We are finalizing the other provisions of subpart L as proposed. For §§ 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 Requireme nts of Subpart L (§  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 farm s to control various aspects of growing, such as humidity, 
temperature, or light, and beli eve 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 greenh ouses, 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 ch ambers, 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 re quirements in subpart L to specifically  
515 
 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 re asonably 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., § 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 state s 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 § 
112.122(b), storage sheds, buildings, or other structures used to store food -contact s urfaces (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.   
516 
  
B. Equipment and Tools (§ 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 § 112.123(b)(2).  
(Response)  We are establishing the requirement in § 112.123(b)(2) because appropriate 
practices for storing and maintaining equipment and tools can protect against contaminatio n 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 reas onably necessary under the circumstances. Separate and distinct from this 
requirement regarding storage and maintenance is the provision in § 112.123(d)(1), which 
requires you to inspect, maintain, and clean and sanitize (when necessary and appropriate) al l 
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 e quipment are all 
reasonably necessary to minimize the risk of produce contamination, and we disagree that  
517 
 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 § 112.123(d)(1) 
with respect to the knife that cuts the asparagus below the ground if the part of the spear th at 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 § 112.123(d)(1) taking into accou nt 
evidence that pathogens can be transferred to produce from contaminated coring devices and 
contaminated food -contact surfaces of tools  (Ref. 204 ) (Ref. 20 5). 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 § 
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 § 112.2(a)(1)).  
  
518 
 (Comment 348) With respect to proposed § 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 reques t 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 covere d 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 § 112.121.  
In contrast to the requirements regarding food -contact surfaces in § 112.123(d)(1), the 
requirements related to non -food-contact surfaces in § 112.123(d)(2) do not require sanitizi ng 
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  
519 
 produce are food-contact  surfaces, and must be inspected, maintained, and cleaned and , as 
necessary and appropriate, sanitized per § 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 § 112.123(d)(2).  
 
C. Instruments and Controls Used to Measure , Regulate, or Record (§ 112.124)  
(Comment 349) One comment generally supports proposed § 112.124.  Another comment 
requests clarification regarding what is meant or intended by “other contamination”.  
(Response)  We are revising §§ 112.121 and 112.124 to del ete 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 contamina tion or undesirable microorganisms 
generally.   
 
D. Equipment Used in the Transport of Covered Produce  (§ 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 f or 
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 c ontamination from bruises or 
cuts that could occur during transport.   
520 
 (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 
transport ing covered produce and is adequate for use in transporting covered produce. This 
provision requires  covered farms to take measures to minimize the risk t hat equipment used 
during transportation become s 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  
adeq uate 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 (§ 112.126)  
(Comment 351) One comment states that, under  proposed § 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 discri minate against smaller 
operations, and also create an unsafe working environment due to “free standing” stacks of bins.  
(Response)  Under § 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 eno ugh for the maintenance of sanitary operations and the conduct of 
covered activities. In the specific circumstance described by the commenter, space between the  
521 
 bins or pallets and the interior wall is not necessary if the bins or pallets can be moved to a llow 
for cleaning activities.   
 
(Comment 352) Some comments express concern regarding proposed § 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 
applicabil ity 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 grow ing, as well as 
cold storage buildings from coverage under proposed § 112.126(a)(3) and/or creating alternative 
standards, recognizing that condensation cannot be prevented in such buildings.  
(Response)  Proposed § 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 ce rtain covered activities conducted in fully - or partially -enclosed buildings. For  
522 
 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 condens ate 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 o f 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 
necess ary 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 re quiring farms to prevent 
condensation or drip contact with covered produce or food-contact  surfaces  
We are deleting proposed § 112.126(a)(3) and replacing it with a new provision under § 
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,  
keep ing buildings in good repair so as to prevent leakage of rainwater into the walls or ceiling s  
523 
 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 m easures 
also include adequately and regularly clean ing 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 require ment in proposed § 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 ar e deleting § 112.126(a)(3) and replacing it with a new provision under § 
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.  
  
524 
 (Comment 354) One comment e xpresses concern that proposed § 112.126(a)(3) would 
require farm s 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 §  112.126(a)(3) and replacing it with a new 
provision under § 112.126(b); see Comment 352 . Under § 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, § 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.  
 
F. Toilet Facilities (§ 112.129) and Hand-Washing Facilities (§ 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 § 112.129(b)(2) be revised to remove the reference to a  
525 
 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 § 112.129) and hand -washing facilities (in § 112.130) should either simply reference 
OSHA field sanitation stand ards 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 §§ 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 (§ 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 o ne 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 labore r’s place of work in the field (paragraph (c)(2)(iii)).   
526 
 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 §§ 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 fie ld 
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 require ments 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 § 112.129(c), during growing activities that take place in a 
fully -enclosed building , and during covered harvesting, packing, or holding activities, you are  
527 
 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 thei r 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 §§ 112.129 and 112.130 to establish requirements for toilet an d 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 
§ 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 like ly 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. Fi nally, 
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  
528 
 single -use towels (29 CFR 1928.110). In light of the OSHA definition and comments, we are 
revising § 112.130(b)(3), which requires that hand -washing facilities be f urnished 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 pre vent 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/sanitize r in 
proposed § 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 requir ement 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 substitutes for washing hands w ith 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 reduci ng 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  
529 
 effective surfactants other than soap may be used in lieu of soap during hand -washing , and we 
are revising  § 112.130(d)  to be  consistent with §  112.130(b)(1), which we are retaining as 
proposed.  We are  also revising § 112.130(d) to use the term “antiseptic hand rubs” to 
collectively refer to leave -on antiseptic products, such as h and sanitizers or wipes.   
 
G. Controlling Animal Excreta and Litter From Domesticated Animals (§ 112.134)  
(Comment 361) One comment requests clarification on whether § 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 § 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 pre vent 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 o f § 112.127 regarding domesticated animals 
in and around a fully -enclosed building, and, when applicable, the requirements related to 
animals in subpart I.  
  
530 
 XVIII . Subpart M – Comments on Sprouts  
In subpart M of proposed part 112, we proposed to establis h 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 a pplied 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   
Proposed Provision  Final 
Provision  Description of Revisions  
 § 112.141  - New section  to describe the scope of subpart M  
§ 112.141  § 112.142  - Revision to combine all requirements for seeds and beans into § 
112.142  
- Revision to § 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 foodbo rne 
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 § 112.142(c) certain limited circumstances 
under which you are not required to take the steps set forth in § 
112.142(b)  
§ 112.142  § 112.143  - Revision to summarize in this section all measures that need to be  
531 
 taken for growing, harvesting, packing, and holding, with relevant 
cross -references to other parts of subpart M. (We have added § 
112.143(c) referring to testing requirements in § 112.144 ; § 
112.143(d) referring to the written environmental monitoring plan 
required in § 112.145; § 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 § 
112.146; § 112.143(f) referring to the written sampling plan required 
in § 112.147, and § 112.143(g) referring to the actions you must take 
when samples of spent irri gation water or sprouts test positive for a 
pathogen as required in § 112.148.)  
- Revision to move requirement for treating seeds and beans into § 
112.42  
§ 112.143  § 112.144  - Revision to clarify the soil -grown sprouts example in § 
112.144 (b)(2)  
- Additio n of new § 112.144 (c), and revision to § 112.144 (b), to 
require additional pathogen testing when  certain specified criteria are 
met 
§ 112.144  § 112.145  - Revision to clarify that you must aseptically collect environmental 
samples in § 112.145 (d) 
- Addition of requirement in § 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  
§ 112.145  § 112. 146 - New provision  § 112.146 (f) to indicate that you must take 
appropriate action to prevent any food that is adulterated from 
entering commerce  
§ 112.146  § 112.147  - Addition of  requirement in § 112.147 (b) that you must not allow a 
production batch of s prouts to enter commerce until you receive 
negative pathogen testing results on spent sprout irrigation water or 
sprouts  
- Addition of  requirement in § 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  
 § 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 §  112.144(c)  
§ 112.150  § 112.150  - Revision to § 112.150 (b)(3) to clarify recordkeeping requirement 
related to written sampling plan for each production batch of sprouts 
in accordance with § 112.147(a) and (c)  
- Revision to § 112.150(b)(4) to require documentation of results of 
all analytical testing conducted to comply with subpart M  
- Revision to § 112.150 (b)(5) to clarify recordkeeping requirement 
related to any analytical methods used in lieu of methods incorporated 
by reference in §§ 112.152 and 1 12.153  
- Elimination of proposed § 112.150(b)(6) as a corresponding change 
to final § 112.150(b)(5)  
- Addition of new provision (i.e., final § 112.150 (b)(6)) to clarify the 
recordkeeping requirement for actions taken in accordance with §§ 
112.142(b) and (c ), 112.146 , and 112.148  
 
  
532 
 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 
proliferat e 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 l ittle 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 positiv e 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 201 4 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 wi thin 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, t here have been an additional nine 
outbreaks associated with sprouts , accounting for 255 illnesses and 48 hospitalizations,  
533 
 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 t o 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 
contaminatio n 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 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  
534 
 L. monocytogenes  in sprouts (Ref. 21 5) (Ref. 216) (Ref. 217 ). Between 2002 and 201 5, 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 testi ng of spent sprout 
irrigation water or sprouts are negative for certain specified pathogens (see § 112.147(b)). This 
requirement is consistent with current industry best practices  (Ref. 219 ). Together with new § 
112.148(a), thi s requirement will help ensur e that sprout operations take appropriate steps to 
prevent contaminated sprouts from en tering 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.  
  
535 
 (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, mi crogreens 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 o f 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 spr outs 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 sprout s. 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 -develo ped 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 substr ate line. B ecause 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  
536 
 provisions in subpart A, micr ogreens 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 t o 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 
contras t, 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 th at 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 §  112.141 to address this. New § 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  
537 
 substrate -grown sp routs 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 spr outs 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 sprou ts 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” used as an example in proposed § 
112.143(b)(2) so that the example now re fers specifically to “soil -grown sprouts harvested with 
roots” in final § 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 
associat ed 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 example s in renumbered § 112.144(b)(2),  
538 
 “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 spro uts are still growing) for E. 
coli O157:H7 and Salmonella  spp. in accordance with the requirements of § 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 a gree 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 op eration. 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 
(howev er 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.   
539 
  
(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 tra y, 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 ot hers 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 (§ 112.142)  
These requirements were proposed as § 112.141 . We have now renumbered this section 
as § 112.142 as a consequential change from the addition of new § 112.141.  
 
(Commen t 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 spro uting. 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  
540 
 covered under the produce safety regulation, and that FDA should r equire 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. Seve ral 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 sho uld 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 developi ng 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 nece ssary 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).   
541 
 In the 2013 proposed rule, we consider ed 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, ha rvested, 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 ul timate 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 see d growers and handlers provide assurance, through the 
use of agreements, that safe growing and handling practices are employed during the growing,  
harvesting, conditioning,  storage, handling, and transportation of the seeds that the distributor 
will sell t o sprouting operations  (Ref. 22 9). In addition, we believe that proposed § 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 St ates 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  
542 
 (rather than grow their own) seeds or beans, we are revising proposed § 112.141(a), 
renumbered as § 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 see ds or beans.  
Measures required under renumbered § 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 contami nation (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 trans ported 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  
543 
 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 § 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 wi th 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 farm s will be unable to accurately and reliably 
asses s 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 sev eral questions 
regarding follow -up actions that a sprouter may have to take in response to a positive test 
finding.  
(Response)  Proposed § 112.141(b), now renumbered as § 112.142(b), focuses on 
reasonably necessary measures when it is known or there is rea son to believe that a lot of seeds 
or beans that will be used for sprouting is contaminated. As proposed, § 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, y ou 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  
544 
 implication as the v ehicle 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 knowl edge 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 § 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 (§ 112.142(b)(1)). We are also expanding the duties you have under § 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 (§ 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 t he seeds or beans (§ 
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  
545 
 contaminated and is likely to present a health hazard  (Ref. 23) (Ref. 211) (Ref. 212 ).  
It is also important that the  sprout ope ration 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 i nclude 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 suc h 
circumstance, where applicable, the seed grower, distributor, or supplier may be required to 
submit a report to the Reportable Food Registry (RFR), in accordance with section 417 of the 
FD&C Act (21 U.S.C. 350d), which requires responsible parties for fo od 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 provision s under new § 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 § 
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) ((§ 112.142(c)(1)). We are including this option to allow sprout 
farms flexibility in responding to a finding that would otherwi se 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  
546 
 used in the sprouting industry. Such proc esses are far more robust than the seed treatment 
processes described in § 112.142(e) because the seed treatments described in § 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 § 
112.142 (c)(1).  
Second, w e are adding new § 112.142( c)(2) to provide that you do not have to take the 
steps in § 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 reasonabl e 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 see d 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  clean s the equipment and start s 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 p ositive for Salmonella , and follow -up sample 
analysis shows the same Salmonella  serotype that was identified as contaminat ing seed lot A.  
547 
 The sprout operation discovers that cleaning and sanitizing protocols were not followed 
properly following sprout prod uction 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 lot s 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 f ollowing appropriate follow -up sanitation 
procedures, spent irrigation water from seed lot B is no longer testing positive for Salmonella , 
under these circumstances t he 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 suppl ier’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  
548 
 sprout product for which the spent irrigation water tests positive for Salmonella . The sprout 
operation could sprout each seed lot individually. If upon fo llow-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 § 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 § 112.142(b). Under § 112.142(c), the sprout farm could c ontinue 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 tha t 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 kin d triggers the 
requirements in § 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, s upplier, 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 §  
549 
 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 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 § 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 con trol ( 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 § 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  
550 
 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 irriga tion 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 als o revised and renumbered § 112.142 and new § 112.148.  
 
(Comment 370) Some c omments 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 § 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 § 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 § 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 § 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  
551 
 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, des pite 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 ot her competent authorit y has establish ed 
microbiological criteria and requirement s for testing all batches of seeds intended for sprouting  
(i.e., European Commission Regulation No. 2073/2005) . However, a s 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 fr om 
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 supplier s 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 re asonably foreseeable hazards  into sprouts .  
 
C. Growing, Harvesting, Packing, and Holding Sprouts (§ 112.143)   
552 
 These requirements were proposed as § 112.142 . We have now renumbered this section 
as § 112.143 as a consequential change from the addition of new  § 112.141.  For purposes of 
clarification, we are revising final § 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 t o other sections of subpart M. Thus, we have added 
§ 112.143(c) referring to testing requirements in § 112.144; § 112.143(d) referring to the 
written environmental monitoring plan required in § 112.145; § 112.143(e) referring to the 
actions you must take w hen Listeria  spp. or L. monocytogenes  is detected in the growing, 
harvesting, packing, or holding environment as required in § 112.146; § 112.143(f) referring to 
the written sampling plan required in § 112.147, and § 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 § 112.148.  
In addition, because the requirement for seed treatment proposed as § 112.142(c) 
establishes standards applicable to seeds and beans used fo r sprouting, it fits more directly 
under final § 112.142 rather than under final § 112.143 (which was proposed as § 112.142). 
Therefore, we are moving this provision, as revised, into renumbered final § 112.142 and 
finalizing it as § 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  
553 
 treatment prior to sprout production. Some c omments express concern that this rule ma y 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 resulting in at 
least a 3 -log pathogen reduction should be required. Ano ther comment suggests using the term 
“disinfect” rather than “treat” when referring to seed treatments. Some c omments 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” whe n 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 re sistant 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 s upport a variety of 
mechanisms to make this information available to sprout farm s. For example, we are working  
554 
 through the SSA to facilitate development of an educational curriculum and sharing of best 
practices among sprout farm s. 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 sproute d 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, § 112.142 ( e) 
(proposed § 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 revi ew 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 publ ished 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 fo r Dietary Ingredients and Dietary Supplements; 68 FR 12157 at 
12198).  
Under proposed § 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  
555 
 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 eq uipment such as industrial -sized hot water pasteurization 
machines  (Ref. 235 ) that might be cost -prohibitive for a small sprout farm . Therefore, in final § 
112.142(e)(1), we are removing the requirement to treat seeds or beans used for sprouting 
“immediate ly 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.” W e are also adding § 
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 growe r, distributor, or supplier of the seeds or beans that (i) the prior 
treatment was conducted using a scientifically valid method to reduce microorganisms of  
556 
 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 § 112.142 rather than 
under final § 112.143 (which was proposed as § 112.142) . Therefore, we are moving this 
provision, as revised, into renumbered final § 112.142 and finalizing it as § 112.142( e). In 
addition, we are revising the corresponding recordkeeping provision in § 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 Con formance) 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 § 112.142( e).  
 
D. Testing D uring Growing, Harvesting, Packing, and Holding Sprouts (§ 112.144)  
These requirements were proposed as § 112.143 . We have now renumbered this section 
as § 112.144 as a consequential change from the addition of new § 112.141.  
 
(Comment 373) Some  comments s uggest 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 and testing of spent sprout irrigation water or sprouts.    
(Response)  In developing the proposed provisions of subpart M, we tent atively  
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 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 o r sprouts for E. coli O157:H7 
and Salmonella sp p. 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 environm ental 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 transfe r 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. monocytogene s (pathogen) or for an indicator organism ( Listeria  spp.). As discussed 
in the scientific literature, the term “indicator organism” means a microorganism or group of  
558 
 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 f or 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 § 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 
limit ed. Other comments were supportive of testing for Salmonella  spp. and E. coli O157:H7. 
Another comment supports FDA’s tentative decision not to req uire 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 .   
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 (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 meth odology. 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. 24 1) and we are retaining the requirement from proposed § 112.143(b) in 
renumbered § 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 pro posed 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 cr iteria. 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. 24 2). 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,  
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 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 f resh 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 § 
112.144(b) and  added new § 112.144( c) to address this situation.  
 Revised § 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 § 112.144(c).” New § 112.144( c) require s sprout operations  to conduct 
the tests requi red in § 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 sc ientifically 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 § 112.144(c) are 
met. First, the association of the pa thogen 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 § 112.144(b) and (c).  To satisfy § 112.144(c)(1),  
561 
 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 
irrigat ion 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 ur gent 
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 patho gen testing required in accordance 
with § 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 sp ent 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  
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 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 (§ 112.145)  
These requirements were proposed as § 112.144 . We have now renumbered this section 
as § 112.145 as a consequential change from the addition of new § 112.141.  
 
(Comment 376) Several comments agree with our proposed requirement for establishing 
and implement ing a written environmental monitoring plan for Listeria . These comments 
maintain that i t is critical that sprout farm s recognize the importance of designing and 
maintaining a monitoring plan that is not simply compliant with regulations, but is also 
sufficiently tailored to their operation s to be appropriately protective of public health. According 
to another comment, sprout farm s currently routinely test spent irrigation water, but are not 
familiar with and do not currently utilize environmental moni toring.  
(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  
563 
 proposed § 112.144 in renumb ered § 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 § 
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 corre ctive 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 
§ 112.146(b)  regarding aseptic collection of s amples of spent sprout irrigation water or sprouts , 
which we are retaining in final § 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 § 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 § 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 § 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.   
564 
  
(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.  
(Respons e) 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. Howeve r, daily monitoring of sanitation with a rapid 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 
combinatio n 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 Environ mental Testing Results ( § 112.146)  
These requirements were proposed as § 112.145 . We have now renumbered this section 
as § 112.146 as a consequential change from the addition of new § 112.141.  
 
(Comment 378) Some comments state that the language in proposed § 112.145(d) is 
insufficient for public health protection. One comment notes that the requirement as written will 
cause sprout farm s to target sampling in order to achieve negative results with a minimum  
565 
 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 insufficien t 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 th at a discovery of contamination must carry an 
appropriate response. Some c ommenters 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 environ mental 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 § 112.145(a) that sprout farms must 
establish and imp lement 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 i mplement a 
written corrective action plan (as required under § 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 i n 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 § 112.146(d), finished product testing can 
provide useful information in certain s ituations  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  
566 
 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. 24 4), 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, ne cessary 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 renumbe red § 112.146 the provisions proposed as § 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 §  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 § 112.146(f)).  
 
G. Collection and Testing of Samples of Spent Sprout Irrigation Water or Sprouts ( § 112.147)  
These requirements were proposed as § 112.146 . We have now renumbered this section 
as § 112.147 as a consequential change from the addition of new § 112.141.  
 
(Comment 379) Several comments support our propose d 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  
567 
 sprouts” (e.g. alfalfa, clover) only, and th at 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, th erefore, we are 
retaining the provisions in proposed § 112.146 as renumbered § 112.147 with certain  revision s, 
as explained in the paragraphs that follow . We expect the written sampling plan to be 
developed taking into account the farm’s specific growing a nd 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 gr owing 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 § 112.147 in light of certain irrigation practices  (Ref. 227 ). One means to 
comply with § 112.147(b) is to follow the recommendations in the Sprouts Testing Guide  (Ref. 
97).  
We are revising § 112.147(b) to reflect the new provisions in § 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 § 112.147 to refer to testing “for pathoge ns as required in § 112.114(b)” 
and revising § 112.147(b) to refer not to testing for E. coli O157:H7 and Salmonella  spp., but  
568 
 instead generally to “pathogens,” by which we mean those pathogen tests required by § 
112.144(b) and (c). We are also revising § 112.147(b) to require testing using a method as set 
forth in new § 112.153  (see discussion in section XIX .B of this docum ent). 
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 § 
112.147(b) to require  that you 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 E. coli O157:H7, Salmonella  spp., and, if applicable, a pathogen meeting the 
criteria  in § 112.144(c). This is consistent with the requirement in § 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 § 112.144(c), you must take appro priate 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 § 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 § 112.148, and details when and how you wil l 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 § 112.144(c) (see § 112.147(c)).  
Establishing and implementing a written correc tive 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  
569 
 review of appro priate 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 Spro ut Irrigation Water or Sprouts Test Positive for a Pathogen ( § 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 tha t may be adulterated , as indicated by a positive 
finding in the tests required under proposed § 112.146.  
(Response)  In light of these comments, we are establishing new § 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  
§ 112.144( c). In part, § 112.148 requires you to take appropriate action to ensure that 
adulterated food  does not enter commerce (see § 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 § 112.144( c) is required under § 112.144 (b). A production 
batch of sprouts for whic h 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 
injurio us to health. Similarly, a production batch of sprouts for which any of these pathogens is 
detected in the sprouts is considered adulterated under section s 402(a)(1) of the FD&C Act, in 
that the sprouts contain a poisonous or deleterious substance which ma y render them  injurious  
570 
 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 additio n, new § 112.148(b) requires you to take the steps required in § 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 § 112.142(c)). This provision is intended to make clear that the 
requirements in § 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 § 112.142(c). For a  detailed discussion of these 
requirements, see section XVIII.B  of this document.  
In addition, § 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, § 112.148(d) requires you to perform any other actions necessary to prevent 
reoccurrence of the co ntamination. 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.  
  
571 
 I. Records Related to Sprouts  (§ 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 § 112.145 and the written 
sampling plan for each production batch of sprouts already required under § 112.147. Thus, we 
are not revising § 112.150 to add separate reco rds requirements for these corrective action plans 
because they are already covered in § 112.150(b)(2) (written environmental monitoring plans) 
and § 112.150(b)(3) (written sampling plans for each production batch of sprouts). We are also 
adding new requir ement in final § 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 farm s employ to address 
problems identifi ed and verification that those corrective actions were effective.  
(Response)  In proposed § 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 § 112.161(b) and, instead, adding that 
requirement within the records provisions of two relevant subpart s, including subpa rt M. As 
revised , under § 112.150( b)(6), you must establish and keep documentation of actions you take 
in accordance with §§ 112.142(b) and (c), 112.146, and 112.148 . This requires covered sprout 
farms to keep documentation of actions taken related to seed s and beans that may be 
contaminated , in accordance with § 112.142(b) and (c), and corrective actions in accordance  
572 
 with §§ 112.146 or 112.148. For example, if your testing required under § 112.144(a) indicates 
a detection of Listeria  spp. or L. monocytogenes  in the growing, harvesting, packing, or 
holding 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 § 112.146 . 
In addition, in f inal § 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 § 112.153 (see section 
XIX.B of this document). This requirement is consistent with proposed § 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 § 112.152, which we have retained in final § 
112.150(b)(5).  That is, in final § 112.150(b)(5), we require records of any analytical methods 
you use in lieu of the methods that are incorporated by reference in §§ 112.152 and 112.153.  In 
addition, we are eliminating proposed § 112.150(b)(6) as a corresponding change.  
We are also revising proposed § 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 § 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 c omments request cl arification on whether all sprout farm s will 
be subject to part 112 in addition to proposed subpart M, and whether sprout farm s 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 farm s should  
573 
 not be eligible for the qualified exemption or extended com pliance 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 standar ds 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 in to fruits and vegetables, and to provide reasonable assurances 
that the produce is not adulterated . Sprouts are produce (see definition of “produce” in § 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 inc orporated 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  covera ge (under § 112.4 (a)) and the qualified exemption and associated 
modified requirements (under §§ 112.4(b) and 112.5 -112.7) all apply to sprout farms .  
With regard to compliance dates for covered activities involving sprout s, we agree that 
our proposed comp liance 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 co mpared 
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  
574 
 may include a history and severity of foodborne illness outbr eaks. 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 redu ce 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, s prout farms  already use public water supplies  and/or ground water  sources for all 
relevant purposes subject to the  microbial quality criterion  in § 112.44(a)  (Ref. 24 5). 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 § 
112.44(a); or (2) are not relevant to sprouts (i.e., the criteria in § 112.44(b) are only for produce 
other than sprouts).   
Therefore, for covered activities involving sprout s, 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 4 19(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 regula tion. See also  XXIV  of this document  for additional information.   
 
K. Other Comments   
575 
 (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 no t 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 th at we expect to play a role in 
achieving compliance with this rule. In addition, we note that  in the final third -party 
certif ication rule ( published  elsewhere in this issue of the Federal Register ), FDA is 
establishing a voluntary program  for the accredita tion of third -party certification bodies that 
may conduct audits and issue certifications for purposes of establishing an entity’s eligibility to 
participate in the Voluntary Qualified Importer Program ( VQIP ) or to satisfy conditions set  
576 
 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 safe ty regulation, including the role of our federal, State, 
local, territorial, and tribal partners as well as private entities.  
  
 
  
577 
 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 spec ific 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 
chan ges in this section.  
Table 25.-- Description of Revisions to Subpart N  
Final Provision  Description of Revisions  
§ 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 § 112.46  
§ 112.152  - Revision to inco rporate by reference a specific 
method that is based on method s 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 
chap ter 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   
578 
 - Editorial revision to shorten intr oductory text by 
removing duplicative phrase “by testing” and 
unnecessary reference to “in environmental 
samples”  
- Conforming revision to change cross -reference in 
title to § 112.144(a), and to add “harvesting, 
packing, and holding” to title and introductory 
text 
§ 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 § 112.144(b) , and to provide 
flexibility for use of other scientifically valid 
methods  (see § 112.153(a)) and (2) specify that a 
scientifically valid method must be used for any 
other pathogens meeting the criteria in § 
112.144(c)  (see § 112.153(b)) .  
 
A. Responses to Comments  
(Comment 385) One comment suggests revising proposed § 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 § 112.151 to eliminate the method of analysis, as 
published in the  Official Methods of Analysis of AOAC I nternational , as a prescribed method for 
testing the quality of water to satisfy the requirements of § 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.   
579 
 (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, i s appropriate for testing water quality to satisfy the 
requirements of § 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 o ther scientifically valid method that is at least equivalent to a prescribed 
analytical method in accur acy, precision, and sensitivity . See also Comment 9 . We are clarifying 
in §§ 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 be lieve 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 sens itivity to our prescribed methods . 
  
580 
 (Comment 387) Another comment states that if samples are not collected in a sanitary 
manner there is no guarantee that the results will be scientifically valid.  
(Response)  We agree aseptic collection of samples is important, and have added this 
requirement under §§ 112.47(b) and 112.145(d). In addition, we have retained the requirement to 
collect samples aseptically, as previously proposed, in renumbered § 112.147(b). See also 
Comment 233  and Comment 376 . 
 
B. Other Revisions  
With respect to the p rescribed methods for testing agricultural water, we are eliminating 
proposed § § 112.151(a)(1), 112.151(a)(2), and 112.151(a)(3). On further review, we find the 
testing method s specified in proposed § 112.151(a) (1) to (3) inadequate for the purpose of testing 
the quality of water  to satisfy the requirements of § 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 s pecified in proposed §§ 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 § 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 method s, which we have reviewed and we are 
specifying  EPA’s Method 1603 as a prescribed method in final § 112.151( a). We are also adding 
§ 112.151(b)(2) to clarify that if you use an alternative indicator of fecal co ntamination in 
accordance with § 112.49(a) you must use a scientifically valid method to test for the indicator.   
581 
 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 §  112.152 with revisions. Under final § 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 §  112.152).  On further review, we find the 
method that is described in the particular chapter of FDA’s BAM (cited in proposed §  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 incorporat ing by reference a 
method that is  based on the methods a nd procedures in USDA’s Microbio logy Laboratory 
Guidebook, FDA’s BAM, and those used in FDA’s compliance activities . In addition , consistent 
with §  112.151( b)(1), under §  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 § 112.152(a). We be lieve these changes in final §  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 §  112.144(a).  
We are revising both proposed §§  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 § 112.151, and shortening the introductory text in §  
582 
 112.152 by removing the duplicative phrase “by testing” and an unnecessary referen ce to “in 
environmental samples”).  
We are adding new §  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 §  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 (§  
112.153( a)(1)); or using a  scientifically valid alternative method (§ 112.153( a)(2)). The method 
described in §  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 
incor porating by reference this particular method into part 112 for the purposes of testing 
required under §  112.144(b). In § 112.153( a)(2), consistent with §§  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, se nsitivity, and 
precision to the method in §  112.153(a) (1). In addition, § 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 § 112.144(c). 
By prescrib ing the method of analysis and incorporating sufficient flexibility for the use of 
scientifically valid alternative methods, we expect new §  112.153 to help covered farms meet our 
testing requirements in  § 112.144(b).  
 
C. Incorporation by Reference   
583 
 In § 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 § 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 approv ed 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 § 112.144(a).  This is an enrichment method for the detection of 
Listeria  spp. in the environment of sprout f arms 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 § 112.144(b).  This method includes : (1) screening procedures by real -time PCR 
to establish the presumptive prese nce 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 
Salmonella  spp., followed by confirmation of the presence of Salmonella  spp. by a variety of 
confirmatory tests.  We are specifying these  prescribed method s, while also providing the 
flexibility for use of other scientifically valid methods, to help covered farms to meet our testing 
requirements in §  112.144.   
584 
 In § 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 a pproved 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, N.W., Washington, DC 20460. 202 -564-6620; 
http://water.epa.gov/scitech/methods/cwa/bioindicators/upload/m ethod_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 q uality of water to satisfy the requirements 
of § 112.46. We are specifying this prescribed method, while also providing the flexibility for 
use of other scienti fically valid methods, to help covered farms to meet our testing requirements 
in § 112.46.  
  
585 
 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 w ith 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 th ese 
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 requir ements. For § 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  
§ 112.161  - Revision to eliminate proposed § 112.161(b) and, instead, 
add that requirement within the records provisions of the 
relevant subpart, i.e., §§ 112.50(b)( 6) and 112.150( b)(6) 
- Renumber proposed § 112.161(c) as § 112.161(b)  and 
make conforming edits to update cross references  
- Revision to add the phrase “except as otherwise specified” 
in § 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 § 112.7 within 
renumbered § 112.161(b)  
§ 112.162  - Revision to remove “after 6 months following the date the 
record was made” to allow immediate offsite storage of 
records pro vided they can be retrieved and provided onsite 
within 24 hours of request for official review   
586 
 § 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 rec ords must satisfy the 
requireme nts 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  
§ 112.164  - Revision to add new § 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 § 112.164(a)(1) to replace “2 ye ars” with “at 
least 2 years” so the length of record retention in this 
provision is harmonized with new § 112.164(a)(2)  
- Revision to § 112.164(b) to specify that “records that 
relate to analyses, sampling, or action plans being used by 
a farm, including t he results of scientific studies, tests, and 
evaluations” must be retained for at least two years after 
the use of such records is discontinued  
§ 112.165  - Revision to establish that electronic records maintained to 
satisfy this part 112 are exempt from t he 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  
§ 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.   
587 
 (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 m inimizing the risk of such hazards; and (3) records are 
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 belie ve 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 contaminatio n 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 farm s.  
(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  
588 
 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 c haracteristics 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 
§ 112.163). We are further clarifying in this final rule that y ou are not required to keep all of the 
information required by part 112 in one set of records. In addition, per § 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 fo rms, 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., 
§§ 112.2(b)(4), 112.7, 112.30, 112.50, 112.60, 112.140, and 112.150). We will consider  
589 
 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 com ponent of the 
food safety system instead of establishing the recordke eping 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 relevan t requirements of the rule. We are not 
establishing new labeling requirements in this rule other than as set forth in § 112.6(b) for farms 
eligible for the qualified exemption  and § 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; 
howev er, such requirements are outside the scope of this rule.  
 
B. General Requirements Applicable to Records Required Under Part 112 (§ 112.161)  
(Comment 392) Stating that on -farm records are often recorded in pencil, one comment 
expresses concern that, under the proposed requirements of § 112.161, records would have to be  
590 
 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 § 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 we re 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 s uch 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 exp ress support for proposed § 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 supe rvisor, in which case he or she should also be allowed to document the review 
of the records.  
(Response)  We are making some  change s by eliminating proposed § 112.161(b) and, 
instead, adding that requirement (as necessary ) within the records provisions of the relevant 
subpart s. 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  
591 
 final §§ 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 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 d iscussed in section 
XIV.H  of this document ) are necessary . Therefore, we are not adding additional documentation 
requirements in §§ 112.30, 112.60, or 112.140 solely as a result of eliminating proposed § 
112.161(b) . With the elimination of proposed § 112.1 61(b), we have renumbered proposed § 
112.161(c) as § 112.161(b) , and we have also made conforming edits to update the cross -
references in the provision that is now § 112.161(b).  
Regardless of who creates or prepares the initial documentation, if the record  is one that 
is required under §§ 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 § 112.7(b) (see Comment 139 ). In addition, in accordance with 
§ 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 §§ 112.161(a)(4) and 
112.1 61(b).  
We have also revised § 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  
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 requirements that are different from the ones in subpart O (e.g., § 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 (§ 112.162)  
(Comment 394) Several comments express concern  with our proposed provision § 
112.162(a) that would prohibit off -site storage of records for the first six mont hs after a record is 
created. These c omments 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 2 4 hours of request for official review.” Another comment recommends also adding “or a 
reasonable period of time” as an alternativ e to help alleviate the burden.  
(Response)  We understand the seasonal nature of certain farming operations and the fact 
that ma ny farms have multiple growing sites that may not be contiguous. Proposed § 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 o ne general (but 
not necessarily contiguous) physical location, they are part of one farm under our definition of 
farm (see § 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 electr onic records, accessible from a site on that farm, see § 
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  
593 
 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 requi re a single farm to set up a 
mechanism to store records related to each field separately at different locations. Nevertheless, 
we are revising § 112.162(a) to permit offsite storage of required records provided such records 
can be retrieved and provided on site 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 satisf y 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 § 112.162(a) is consistent with our regulation on Production, 
Storage, and Transportation of Shell Eggs, 21 CFR part 118, which allows for offsite st orage of 
records , except for the written Salmonella  Enteritidis  prevention plan, which must be stored o n-
site (see §  118.10).  
 
D. Use of Existing Records (§ 112.163)  
(Comment 395) Several commenters express support for proposed § 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 .  
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 (Response)  We are revising proposed § 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 bur den 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 § 11 7.330 in the PCHF 
regulation, we are revising proposed § 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 
requi red 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.   
595 
 We acknowledge tha t 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 § 
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 an d 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 identify ing 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, th e 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 th e 
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 perfor ming 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 (§ 112.164)  
We received some comments generally supporting proposed § 112.164. We are retaining 
§ 112.164 with certain  changes. First, we are adding new § 112.164(a)(2) to require that records  
596 
 that a farm relies on during the 3 -year period preceding the applicable cal endar year to satisfy the 
criteria for a qualified exemption, in accordance with § § 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 docu ment, the criteria for a qualified exemption established in this 
rule (in § 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 § 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 
§ 112 .164(a)(2).  
Finally , we are revising § 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 § 112.4 6(b) can be 
comprise d 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 § 112.4 5. Because 
these results are necessary to verify the use of the agricultural water in comp liance with the  
597 
 microbial quality criteria  in § 112.44 as well as any time interval in compliance with the 
microbial die -off provisions in § 112.4 5(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 p lan (required under § 112.145) and written sampling plan (required 
under § 11 2.147) 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 (§ 112.165)  
(Comment 396) Several comments  express concern about the proposed requirement in 
proposed § 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 m ay 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 implem ent 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 d eleted 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 com menter 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  
598 
 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, pa rticularly in 
light of frequent software patches and security updates and the use of open source software by 
some farms. Therefore, we are revising § 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 § 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 p rovisions 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 curre ntly 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 § 11.1(k) that part 11  does not apply to records required to be established or 
maintained under part 112, and that rec ords that satisfy the requirements of part 112, but 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 reg ulation 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  
599 
 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 (§ 112.167)  
(Comment 397) One comment asks FDA to a ffirm 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 s mall business es may not 
be fully aware of FDA’s ability to disclo se certain types of materials. The commenter asks FDA 
to provide guidance to assure  that covered farms understand FDA’s procedures for publicly 
disclosing certain su bmitted 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 t he 
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 genera l 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 f ollowing 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 t o those documents obtained by FDA  under this rule .   
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 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 procedur es 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 procedure s 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 
§§ 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  
§ 112.171  - Revision to establish that Federally -recognized tribes may 
submit a variance petition; and corresponding changes 
throughout subpart P  
§ 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.”)   
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 § 112.176  - Revision of § 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  
§ 112.177  - Editorial revision to treat “website” as one word  
§ 112.179  - Editorial revision to add the word “on” before “the date of 
our written decision”  
§ 112.181  - Editorial revision to treat “website” as one word  
§ 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 (§§ 112.171 and 112.172)  
(Comment 398) Several comments express concerns about the lack of allowance for 
tribes to request variances from the r equirements 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 § 
112.171, and al l other provisions in subpart P that apply to a petition submitted by a State apply 
equally to a petition submitted by a Federally -recognized tribe (Ref. 246 ). In light of comments, 
we are adding “ tribe” in part 112 to clarify for purposes of this rule tha t “tribes” are included. To 
make this explicit, we are revising § 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 s ubpart P . 
  
602 
 (Comment 399) One comment seeks clarification on who would be considered a 
competent authority for a State or foreign government, as proposed in § 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 us e 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 auth orities in the European Union  (Ref. 249) . We are editing § 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 government s. A number of comments contend that 
additional groups, including State and federal commodity organizations, commodity boards, 
commodity commissions, trade associations, or other coalitions of farm s should also be 
permitted to request variances using the s ame 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   
603 
 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 s olely on State agencies.  
(Response)  The provision in § 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 explici tly 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 
assoc iations. 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 a uthorities 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 rec ognizes 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 GAP s (Ref. 250) ; and the Pr oduce GAPs 
Harmonization  Initiative  (Ref. 251)  (Ref. 252) ). As noted previously , the processes in part 112,  
604 
 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 scie ntific 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 p rovide 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 § 112.174), which may ease the bur den on States, tribes, and foreign 
governments. In addition, in accordance with § 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 c overed farms who are similarly situated within its jurisdiction.  
  
605 
 (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 proc ess for requests for variances from foreign competent authorities. This 
comment notes unfamiliarity with the petition process in § 10.30, but expects FDA to compare 
and contrast, and modify the currently proposed process to fit with WTO guidelines.  
(Respon se) 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 (§ 112.173)  
(Comment 403) Comments generally support the proposed requirements related to 
processes, scientific data, and information to support a variance 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 t he 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  
606 
 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 req uest 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 we ll 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 pro cedures, 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 provid e the same level of public health protection as the  
607 
 corresponding requirement(s) of the produce safety regulation  for which a variance is requested. 
FDA encourage s 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 § 112.4 5(b)(1)(i). We derived this die -off rate based on a review of curren tly 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, an d 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 co nclude 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 § 
112.4 5(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 
geograph ical 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  
608 
 to FDA. (Note that a covered farm can also establish an alternative microbia l die-off rate  and an 
accompanying maximum time interval , in accordance with §§ 112.12(a) and 112.4 9(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 scie ntific 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 r egion ( 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 indust ry 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 
varianc e 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, § 112.177 ensure s consideration of the application 
of variances to simila rly situated persons and provide s 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  
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 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 pe tition.  
 
C. Process for Requesting a Variance (§  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 criteria for how infor mation supplied in support of variances will be evaluated.  
(Response)  We are establishing the general procedures applying to variance petitions in § 
112.176. Under these procedures, a State, tribe, or foreign country from which food is imported 
into the Un ited States may in writing submit a request for a variance(s) to the FDA using the 
process described in § 10.30. Such a request shall describe the variance requested and present 
information demonstrating that the variance does not increase the likelihood t hat 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 § 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 R egister , 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 noti ce 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  
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 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 website. We intend to make readily accessible to 
the public, and per iodically 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 informat ion 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 § 
112.171). We will also look for a Statemen t 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 (§ 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 befo re 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  
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 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 estab lish 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 (§  112.182)  
(Comment 407) One comment not es 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 § 112.182 of the rule creates the impression that only variances in those  
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 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 § 11 2.182 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 § 112.171. We are revising  § 112.182 to make 
our intent clear and to revise and update the list of  examples. As revised, § 1 12.182 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 g rowing activities for covered produce (other than 
sprouts) using a direct water application method , established in § 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 § 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 § 112.44(b) , established in § 112.4 6(b). 
 
E. Other C omments  
(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  
613 
 governments to help them determine which of the two options – a request for variance or for 
systems recognition – is more appropriate given their particular circumstance s.  
(Response)  Variances, s ystems recognition, and equivalence are distinct regulatory tools, 
each requiring different analyses, although they do overlap somewhat. As described in this rule , 
a foreign country may submit a request for a variance(s) by, amon g 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 est ablished under part 112. Systems r ecognition, 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 appropria te 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 r ecognition 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 de monstrate 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 .  
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 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 arrangem ents. 
We note that FDA’s pilot s ystems 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, wi th 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 sta ndards, 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 
arrangeme nts 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 scenar ios and possibilities regardin g the scope of each respective s ystems 
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 s ystems recognition can be found at FDA’s website: 
http://www.fda.gov/food/internationalinteragencycoordination/ucm367400.htm  
  
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 (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 cons istently 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 t ested, 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, no t 
just at a State level. As discussed previously , this subpart provides a variety of mechanisms for  
616 
 applying some or all parts of a variance to other similarly situated persons, including to a region, 
rather than to a single State.  
 
  
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 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 cri teria 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 pr oposed 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, t erritorial, tribal, and local authoritie s. 
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 § 112.191 and 112.192 and, therefore, we do not discuss final § 112.192 
further.  
Table 28.-- Description of Re-arrangement and Revisions to Subpart Q  
Proposed Provision  Final Provision  Description of Revisions  
§ 112.191  § 112.192  - Revision to combine proposed §§ 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 § 112.191 as new provision § 
112.192( b), along with revisions for clarity to separate the 
authorities cite d from FD&C Act from that cited from the PHS 
Act. 
§ 112.192  -  
§ 112.193  § 112.193  - Revision to clarify that FDA coordinates education and 
enforcem ent activities by State, t erritorial, 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  
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 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 t heir 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:   
619 
 Deploying a cadre of produce safety experts in headquarters and the field with the depth 
and breadth of capacity to develop the guidance nee ded to support implementation and 
provide technical support to government and industry parties working to foster 
compliance;  
Actively supporting education and technical assistance for farms, primarily through 
collaboration with other public and private p arties;  
Supporting public and private parties involved in audits and other accountability 
functions with technical assistance and other collaborative support;  
Conducting targeted on -farm surveys and inspections to understand current practices and 
identify gaps in compliance;  
Taking administrative compliance and enforcement action when needed to correct 
problems that put consumers at risk;  
Responding to produce outbreaks effectively to lessen impact on public health; and  
Conducting in -depth en vironmental assessments where appropriate to identify root causes 
of outbreaks associated with produce and inform future prevention efforts.  
FDA’s inspection resources will be  target ed 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  
620 
 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 t heir 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 t o cooperate and take corrective actions, 
and the risk to public health.  While m any 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 safet y 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 reali ze 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 Session Law 2013 -265 (Senate Bill 63) 
(NC Farm Act of 2013) as providing protection to farmers by entitling the m 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.   
621 
 (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 (§ 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 r equest 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 exi sting 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 pra ctices, 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 succes sful 
inspection processes. Some c omments 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 circumst ances, State agencies lack the authority to enter farms. 
Some c omments also express concerns related to resources necessary for States to conduct 
inspections.    
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 (Response)  As discussed previously , we are revising § 112.193 to clarify that FDA 
coordinates education and en forcement activities by State, t erritorial, 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 complianc e 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 b ehalf of FDA. Qualified State, t erritorial, 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 ind ustry -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  
623 
 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 choo se 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 impleme ntation 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 recen tly 
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 § 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.   
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 (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 operationa l 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  
inspection s 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 c ommen ts also recommend  that inspectors should  have familiarity with 
acceptable on -farm practices taking into consideration the diversity of agricultural practices, 
conditions and commodities.  
(Response)  See our response to Comment 411 , in which we discuss our expectation that  
inspection s 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 develo ping 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. Person nel performing farm inspections may include  federal investigators, 
State inspectors, or other authorit ies, and will likely vary by State. In addition, FDA plans to  
625 
 deploy a cadre of produce safety experts in headquarters and the field with the depth and br eadth 
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 inspect ions, 
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 c omments 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 F DA 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 intend s 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;  
626 
 however, there will likel y be instances where a f arm 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 farm s 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, stat ing 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 suffici ent 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  
627 
 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 th at 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 confo rmance 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  regulation s, 
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 reco gnized 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.   
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 We also note that in  the final third -party certification r ule (publish ed 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 ce rtifications 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 farm s 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 inspectio n services for other entities in 
the supply chain. To the extent that the 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 th at 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 appli cable to an  importer when  
629 
 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 ac tivities pre -date FSMA , and FDA  is currently 
refining the p rogram to ensure alignment, where appropriate, with FSMA. While all s ystems 
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 i ncluding 
additional consideration for produce standards, oversight, and production practices particularly 
with respect to the country’s practices and oversight regarding the specific p rovision(s) in part 
112 in its systems r ecognition 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 th is point to determine whether or how existing or future systems recognition 
arrangements may affect our inspections of foreign farms.  
  
630 
 XXIII . Subpart R – Comments on Withdrawal of Qualified Exemptio n 
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 § 112.5. Specifically, pr oposed § 112.201 listed the circumstances 
under which FDA may withdraw a qualified exemption applicable to a farm, while §§ 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 §§ 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 §§ 
112.208 thro ugh 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 provision s, 
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 §§ 112.201 and 112.202 rel ated 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 § 
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 20 13 proposed rule, but that we did not address in the supplemental notice. We  
631 
 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 revisi ons (see Table 29). We discuss 
these changes in this section. For §§ 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 discu ss these provisions  further . 
Table 29.-- Description of Revisions to Subpart R  
Final Provision  Description of Revisions  
§ 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  
§ 112.202  - Editorial change to insert the word “either” in § 112.202(a)  
§ 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  
§ 112.203(d)  - Revision to require that the contents of an ord er 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 §§ 
112.204(a) and 112.205(b)  
§ 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 § 112.213  
§ 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 §§ 112.206(a)(1) and 
112.207(a)(2)  
§ 112.205(b)(2)  - Specifies that a farm that loses its qualified exemption 
would no longer need to comply with the modified 
requirements in §§ 112.6 and 112.7  
§ 112.208(a)  - Revision to allow for the hearing to be held within 15 
calendar days after the date the appeal is filed  
§ 112.213 (a) - Editorial change to replace the word “shall’ with “will”  
 
A. Circumstances That May Lead FDA to Withdraw a Farm’s Qualified Exemption (§ 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  
632 
 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 § 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 proc ess 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 disagre e 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 be cause 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 exemptio n 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 e nforcement actions 
but disagree that specifying this customary practice in the rule would prevent us from acting  
633 
 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 wit hdraw 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 circumst ances 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 orde r 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.  
  
634 
 (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 withd raw 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 m ay 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 § 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 qu alified 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 far m’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  
635 
 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 crit eria that must be met for a farm to be eligible for a qualified 
exemption.  
 
B. Contents of an Order to Withdraw a Qualified Exemption (§ 112.203)  
(Comment 428) Some comments recommend that the order specify which of the two 
circumstances (§ 112.201(a)(1) o r § 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 o rder, 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 § 
112.203(c).  
 
(Comment 429) Several comments reco mmend 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 descripti on, as described in § 112.203(c). Comments argue that a brief, general 
description supporting the order to withdraw a qualified exemption is not sufficient to allow the  
636 
 farmer to adequately respond to the order or prepare for an appeal hearing. Comments al so 
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 particulari ty 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 explaini ng 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  
637 
 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 in formation 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, a nd 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 confirma tion 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  § 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 
§ 112.213.   
638 
 (Response)  We are revising the requirements for the contents of an order as requested 
by these comments (see § 112.203(e)).  
 
(Comment 432) One comment recommends that the order specify the two options that a 
farm has upon receipt of the or der, 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 th ough the order would otherwise 
include this information (because the order will contain the full text of the withdrawal 
provisions under § 112.203(f)). In § 112.203(d), we are requiring that the contents of an order 
must include a statement that the farm m ust either comply with or appeal the order.  
 
C. Compliance With, or Appeal of, an Order to Withdraw a Qualified Exemption (§§ 112.204 , 
112.205, and 112.206)  
(Comment 433) Several comments express that 60 calendar days in proposed § 
112.204(a) is not sufficient time for a farm to comply with an order withdrawing its qualified 
exemption. Several comments recommend revising proposed §§ 112.203(d) and 112.204(a) to 
require co mpliance 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 busine ss 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  
639 
 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 re vising §§ 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 
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 § 112.201(b)). If the farm requests a hearing, 
more than 40 days could elapse betw een 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 
investigatio n 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 ass ociated with  
640 
 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 pie cemeal 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 regulation s (79 FR 58434 at 58467). We have made the administrative proc edures 
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 dat e of receipt of the order. See the 
revised regulatory text in provisions §§ 112.203(d), 112.204(a), and 112.205(b).  
For clarification, w e are specifying, in  new § 112.205(b)(2) , that a farm that loses its 
qualified exemption would no longer need to comply  with the modified requirements in §§ 
112.6 and 112.7 . This revision is also consistent with provisions in the PCHF regulation.   
641 
  
(Comment 434) Several comments request longer than the proposed 10 calendar days to 
file a written appeal of the order of withd rawal 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 con sistent 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 § 112.206 within 15 calendar days from the date 
of receipt of the order. See the revised regulatory text in provisions §§ 112.204(b), 
112.206(a)(1), and 112.207(a)(2). We are also revising § 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 t he appeal is filed to provide more 
time for the farm to prepare for the hearing (see § 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  
642 
 and FDA; a farm that woul d 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 , circu mstances 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 (§ 112.207)  
(Com ment 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 quali fied exemption, and we have provided for a right to appeal.  
 
E. Informal Hearing (§ 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 commen t 
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  
643 
 final decision, and ask us to revise  proposed § 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 promp t action and that a farm has the opportunity for judicial review in accordance with 21 
CFR 10.45.  
(Response)  We decline this request. In § 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 ad dition, in § 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, an d further mechanisms are not warranted.  
 
F. Circumstances Related to Reinstatement of a Qualified Exemption That is Withdrawn (§ 
112.213)  
(Comment 438) Some comments agree with our tentative conclusion that the absence of a 
specific provision in 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 
withdrawa l 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 ex emption of a farm.  These  
644 
 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 § 112.201(b)) that we will first seek to correct 
problems before considering withdrawal. These comments also que stion 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 sta tus. 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  
645 
 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 reinstate ment 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  
646 
 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 withdraw n 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.  
  
647 
 (Comment 441) One comment believes that the word “will” in proposed § 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 § 112.213(a) to be consistent with § 112.213(c), in the interest of using plain language 
in drafting regulations.  
 
G. Other C omments  
(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 withdr aw 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.  
 
H. Conforming Amendment to 21 CFR Part 16  
We proposed to amend § 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 disagr eed with this proposed 
provision, and we are finalizing it as proposed.   
648 
 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 propos ed 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 § 112.7(b) to maintain 
to support its eligibility for the qualified exemption ( e.g., sales receipts and other records as  
649 
 applicable) is the effective date of this rule, i.e., [ INSERT DATE 60 DAYS AFTER DATE OF 
PUBLICATION IN THE FEDERAL REGISTER DATE ]. 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 § 112.6(b)(1).  
Table 30.-- Compliance Dates 
Size of 
covered 
farm  Covered 
activities 
involving 
sprouts 
covered under 
subpart M  
(i.e., subject 
to all 
requirements 
of part 112)  Covered activities involving all 
other covered produce ( i.e., 
subject to part 112, except 
subpart M)  Farms eligible for a qualified exemption (if 
applicable)  
Compliance 
date for 
certain 
specified 
agricultural 
water 
requirements  Compliance 
date for all 
other 
requirements  Compliance 
date for 
retention of 
records 
supporting 
eligibility in 
§ 112.7(b)  Compliance 
date for 
modified 
requirement 
in § 
112.6(b)(1)  Compliance 
date for all 
other 
requirements 
in §§ 112.6 
and 112.7  
Time periods starting from  the effective date of 
this rule  
Very small 
business  3 years  6 years  4 years  Effective date 
of rule  
 
 January 1, 
2020  
 4 years  
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 governme nt 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  
650 
 associated potential costs. One comment states implementation o f 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 busi nesses 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 require ments 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 determinatio n 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 sectio n 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  
651 
 (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 require ments 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 ver y 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 t hese 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  
652 
 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 e xception 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 follo w) 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 disc ussed 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: §§ 
112.44, 112.45, 112.46 (except § 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 co vered farms that are small businesses, and 4 years from the effective date for 
all other covered farms.  
  
653 
 4. Compliance Dates for Farms Engaged in Covered Activities Involving Sprouts Covered Under 
Subpart M as Well as Other Covered Produce  
For those covere d 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 t hree additional compliance dates appl icable to farms eligible for a 
qualified exemption. First, a s 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 § § 112.5 and 112.7  is the effective date of this rule, i.e., [ INSERT DATE 60 
DAYS AFTER DATE OF PUBLICATION IN THE FEDERAL REGISTER ]. 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 § 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  
654 
 farm where the food is grown, harvested, packed, and held (see § 112.6(b)). If a food packaging 
label is required, the required notification must appear prominently and con spicuously on the 
label of the food (see § 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 re vised 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 f inal 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, 2 016, 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 label ing regulation is issued and the date when a food 
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  
655 
 exemption would become subject to the modified requirement in § 112.6(b)(1) during this 
timeframe – i.e., by December 31, 2018 . The compliance date that we are establishing for the 
modi fied requirement of § 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. T his 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 §§ 112.6 and 11 2.7. As explained under Comment 120 , because of the 
difference in the bases for monetary cut -offs established in § 112.3 and in § 112.5, farms that are 
eligible for the qualified exemption may be either  small business es or very small business es (as 
defined  in § 112.3). Farms eligible for a qualified exemption (in accordance with § 112.5) must 
comply with all other modified requirements of §§ 112.6 and 112.7 within the compliance 
periods established for either a small business or a very small business, which ever is applicable.  
Based on the monetary cut -offs and definitions  in § 112.3 and in § 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 f ollowing 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,  
656 
 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 conformi ng amendments are 
effective on [ INSERT DATE 60 DAYS AFTER DATE OF PUBLICATION IN THE FEDERAL 
REGISTER ], the same date as the effective date of part 112. We are not establishing compliance 
dates for these conforming amendments. As a practical matter, compli ance 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 (§§ 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 [ INSERT 
DATE 60 DAYS AFTER  DATE OF PUBLICATION IN THE FEDERAL REGISTER ], the 
same date as the effective date of part 112.  
  
657 
 D. Effective Date for Certain Provisions in the PCAF Regulation  
The final animal preventive controls rule established five new provisions (§§ 
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 a re effective 
on [INSERT DATE 60 DAYS AFTER DATE OF PUBLICATION IN THE FEDERAL 
REGISTER ], 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 
offici als. 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 Analys is 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 12 866 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 an d safety, and other advantages; distributive impacts;  
658 
 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 $14 4 million, using the most current (201 4) Implicit P rice 
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 analys is 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/Economic Analyses/ . 
 
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  
659 
 14, 2015). FDA considered the comments received on 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, Harvesting, 
Packing, and Holding of Produce for Human 
Consumption (Note: the categorical exclusion statement 
was cited as a reference in this document)  78 FR 3504; January 16, 2013  
Notice of Intent to Prepare an Environmental Impact 
Statement for the Proposed Rule  78 FR 50358; August19, 2013  
Extension of Comment Period for the Environmental 
Impact Statement  78 FR 69006; November 18, 2013  
Public Meeting on Scoping of Environmental Impact 
Statement and Extension of Comment Period for the 
Environmental Impact Statement  79 FR 13593; March 11, 2014  
Draft Environmental Impact Statement Notice of 
Availability  80 FR 1852 ; January 1 4, 201 5 
 
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 w ith 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   
660 
 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 min imum 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 th at 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 approximate ly 285 sprouting operations covered by this rule.  One section 
of the regulation also applies to some non -farm ent ities as described in the Third -Party 
Disclosure Burden sub -section of this section.    
Exemptions or Eligibility for Exemptions  
The rule includ es provisions under which certain farms and produce are either not 
covered or eligible for an exemption and, instead, subject to certain modified requirements (see  
§§ 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 col lection as follows:   
661 
 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 §§ 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  × 20 percent that do not rely on die -off] + [3,958 farms from 
table 19 of the RIA  × 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 requirement s. 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  × 0.5 = 2,773 
one-time hours to meet the requirement of § 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 washi ng, to achieve a calculated log reduction of generic E. coli in accordance with 
§ 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  × 80 percent that rely on die -off × 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  
× 2 × 0.5 = 3,661 one -time hours to meet the requirement of § 112.50(b)(5).   
662 
 Section 112.50(b)( 8) requires all farms that choose to rely on an alternative under § 
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 § 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 § 
112.44(b). We estimate that approximately 8,757 farms th at irrigate (35,029 total farms  × 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 the documentation of scientific 
data and information. Therefore, 8,757  × 0.5 = 4,376  one-time hours to meet the requirement s of 
§§ 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 § 
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 × 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 
document ation of scientific data and information. Therefore, 3,661  × 0.5 = 1,830 one -time hours 
to meet the requirement s of §§ 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 § 112.46(b)(1)(i)(A). We estimate that approximately 2,551 farms that utilize  
663 
 surface water (12,554 irrigated farms that use surface water less the percentage estimated  on 
public water sources  × 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 consis t of gathering and maintaining the 
documentation of scientific data and information. Therefore, 2,511  × 0.5 = 1,255 one -time hours 
to meet the requirement s of §§ 112.50(b)(8)  and 112.49(c).  
 Section 112.49(d) provides for an alternative minimum number of s amples used in the 
annual survey for an untreated surface water source, in lieu of the minimum number of samples 
required under § 112.46(b)(2)(i)(A). We estimate that approximately 2,551 farms that utilize 
surface water (12,554 irrigated farms that use sur face water less the percentage estimated on 
public water sources  × 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  × 0.5 = 1,255 one -time hours 
to meet the requirement s of §§ 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 § 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 re ference in § 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 coll ect the documentation of the alternative analytical methods.  
Sprouts -Establishment of Environmental Monitoring Plan   
664 
 Section 112.150(b)(2) requires sprout operations to establish and keep a written 
environmental monitoring plan in accordance with § 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, deter mining 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  × 7 hours = 321 one -time hours to comply with 
§ 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 templa te for the plan) is a one -time 
burden of 12 hours. Therefore, 37 farms  × 12 hours = 446 one -time hours to comply with § 
112.150(b)(2). For 94 large farms, it is estimated that the establishment of this environmental 
monitoring plan (that is, determining th e 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  × 17 hours = 1,592 one -time hours to comply with § 
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 § 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  
665 
 sampling plan is 8 hours. Therefore, 8 hours  × 177 sprout farms = 1,414 one -time burden hours 
for sprout farms to comply with § 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 §§ 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 col lect the documentation of the alternative analytical methods.   
In addition, § 112.144(c) requires sprout operations to conduct testing for additional 
pathogens when certain conditions are met, and § 112.150(b)(5) requires sprouting operations to 
have docum entation of any analytical methods used for such testing because there is no specific 
method for such testing incorporated by reference in § 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  × 2) to fulfill thi s requirement. At two hours per record, this represents a total 
hourly burden of 707 (353  × 2) to fulfill the requirements of § § 112.150(b)(5)  and § 112.144(c).  
Variances  
Section 112.171 of this rule allows States, tribes, and foreign countries to petitio n 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  
666 
 submit a petition to seek a variance, and § 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 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  × 7 petitions 
= 840 hours to comply with the requirements of § 112 .173.  
Annual Hourly Burden  
Qualified exempt farms – documenting eligibility  
Section 112.7(b) requires farms eligible for the qualified exemption in accordance with § 
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 hour s per year on recordkeeping related to documenting eligibility for the  
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 qualified exemption. Therefore, 3,285 recordkeepers  × 0.5 average hours per recordkeeper = 
1,643 hours to meet the requirements of § 112.7(b).  
Training records  
Section 112.30(b)(1) req uires 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  × 
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 trai ning requirements 
(recording and maintaining the dates and topics of training, and person(s) trained) of this final 
rule. Therefore, 24,420 recordkeepers  × 7.25 average hours per recordkeeper = 177,045 hours to 
meet the requirements of § 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 § 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 untr eated 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 r ule. 
Therefore, 26,038 farms  × 2 recordkeepers  × 0.66 average hours per recordkeeper = 34,371 
hours to meet the requirements of §§ 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 Wat er Used For Direct Application Irrigation of Non -Sprout Covered  
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 Produce. Section 112.46(b) requires testing each such source of water used for the purposes that 
are subject to the requirements of § 112.44(b). We calculate that there are a total of 12,554 f arms 
(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 Tes ting 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  
× 6.29 recordkeepers  × 0.92 average hours  per recordkeeper = 72,648 hours to meet the 
requirements of §§ 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 § 112.44(b). We calculate that there are a total of 9,471 farms 
(all irrigated farms using ground water less the percentage e stimated 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  
× 1.4 recordkeepers  × 0.92 average hours per recordkeeper = 12,198 hours to meet the 
requirements of §§ 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 §§ 112.41 or 112.44 are not met (see §§ 112.45(a)(1)(i) and 
112.45(b)(2)) . We calculate approximately one percent  of all irrigated farms will need to conduct  
669 
 these tests; therefore 298 farms (29,763  × 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  × 
1 recordkeeper  × 0.33 average hours per recordkeeper = 98 hours to meet the requirements of § 
112.45.  
Recordkeeping related to water  
Section 112.50(b)(1) requires the establishment a nd 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  × 4 recordkeepers  × 0.8 average hours per recordkeeper = 110,066 
hours to meet the requirement of § 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  × 2 recordkeepers  × 0.33 average hours per recordkeeper = 17,185 
hours to meet the requirements of § 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 Produce. We  
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 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 farm s × 6.29 
recordkeepers  × 0.08 average hours per recordkeeper = 6,317 hours to meet the requirements of 
§ 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 redu ce the recordkeeping burden associated with testing of untreated 
surface and untreated ground water (§§ 112.46(b) and 112.50(b)(2)) and time intervals applied 
between last irrigation and harvest (§§ 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 establishm ent 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  
× 1.4 recordkeeper s × 0.08 average hours per recordkeeper = 1,061 hours to meet the 
requirements of § 112.50(b)(2). As noted previously , we expect development of an online tool to  
671 
 reduce the recordkeeping burden associated with testing of untreated surface and untreated 
ground water required under §§ 112.46(b) and 112.50(b)(2).  
Section 112.50(b)(4) requires Documentation of Results of Monitoring Water Treatment 
under § 112.43(b). We calculate that 5,547 farms (the proportion of covered farms that do not 
use municipal water s ources 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 0.9 8 hours per 
year on recordkeeping related to Monitoring Water Treatment. Therefore, 5,547 farms  × 1 
recordkeeper  × 0.98 average hours per recordkeeper = 5,436 hours to meet the requirements of § 
112.50(b)(4).  
 Section 112.50(b)(6) requires documentation of  any corrective actions taken in 
accordance with § 112.45. Further, where time intervals or (calculated) log reductions are 
applied in accordance with § 112.45(b)(1)(i) and/or (b)(1)(ii), such documentation must include 
the specific time interval or log re duction 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 § 112.45, including any time intervals or calculated log 
reductions applied. Therefore, it is estimated that 1 recordkeeper on e ach 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  × 1 recordkeeper  × 0.5 average hours per recordkeeper = 7,322 
hours to meet the requirements of § 112.50(b)( 6). As noted previously , we expect development  
672 
 of an online tool to reduce the recordkeeping burden associated with time intervals applied 
between last irrigation and harvest as required under §§ 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 § 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 sour ces) 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  × 1 recordkeeper  × 0.33 average hours per 
recordkeeper = 3,005 hours to meet the requirements of § 112.50(b)(7).  
Recordkeeping related to biological soil amendments of animal origin  
Section 112.60(b) of th is 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, § 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 amendmen t 
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 usi ng 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  
673 
 recordkeeping burden for an additional 10  percent  of remaining covered farms (35,029  × 0.1 0 = 
3,503)  Therefore, for the purposes of this analysis, it is estimated that one recordkeepe r 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  
× 0.2 5 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. 2 60), it is estimated th at 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  × 0.1 5 = 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 consist of recording confirmation of process control achievement. Therefore, 420 
recordkeepers  × 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   
674 
 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 a verage of 8 hours per year 
on recordkeeping related to cleaning and sanitizing worker tools. Therefore, 16,061 very small 
farms  × 1 recordkeeper  × 8 average hours per recordkeeper = 128,485 hours to meet the 
requirements of § 112.140(b)(1). We calculate th at 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. The refore, 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  × 1 recordkeeper  × 25 average 
hours per recordkeeper = 215,871 hours to meet the requirements of § 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 estima ted 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  × 1 recordkeeper  × 8 average hours per 
recordkeeper =  105,248 hours to meet the requirements of § 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 in cur the costs of 
recordkeeping related to cleaning and sanitizing machinery. Therefore, it is estimated that 1  
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 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 sanit izing machinery. Therefore, 7,073 small and 
large farms  × 1 recordkeeper  × 25 average hours per farm = 176,831 hours to meet the 
requirements of § 112.140(b)(1).  
Testing requirements related to sprouts  
Sections 112.144(b) and (c), and 112.147 requires test ing 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 § 112.150(b)(4) requires 
recordkeeping related to those test s. 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 s prout 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  × 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  × 2.5) tests.  
It is estimated that a total of 4,163 batches of sprouts wil l 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  × 0.5  hour per test = 2,081 annual hours for very small farms to comply 
with §§ 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  × 0.5  hour per test = 1 ,688 
annual hours for small farms to comply with §§ 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  
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 test × 0.5  hour per = 18,941 annual hours for large farms to  comply with §§ 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 § 112.150(b)(4) requires 
recordkeeping related to th ose 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 num ber 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 incr eases  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 recordke eper from each of the farms will be responsible for collecting 
samples. Therefore, to comply with the requirements of §§ 112.144(a) and 112.145, 33 very 
small farms will incur a total of 300 hours of burden annually (33 farms  × 5 samples  × 12 annual 
tests × 0.1 5 hour per sample); 27 small farms will incur a total of 486 hours annually, (27 farms  
× 10 samples  × 12 annual tests  × 0.1 5 hour per sample); and 68 large farms will incur a total of 
1,835 hours (68 farms  × 15 samples  × 12 annual tests  × 0.1 5 hour pe r 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  
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 recordkeeper per very small farm will document this activity 50 times annually. There fore, 33 
very small farms  × 50 records = 1,665 records  × 0.2  hours per record = 333 hours for very small 
farms to comply with § 112.150(b)(1). It is estimated that one recordkeeper per small farm will 
document this activity 50 times annually. Therefore, 27 small farms  × 50 records = 1,350 records  
× 0.2  hours per re cord = 270 hours for small farms to comply with § 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  × 223 records = 15,153 records  × 0.2  hours per record = 
3,031 hours for large farms to comply with § 112.150(b)(1).  
Section 112.150(b)(2) requires sprout operations to establish and keep a written 
environmental monitoring plan in accordance with § 112.145. It is estimated that there is a one -
time burden to estab lish 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 burde ns, 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  × 0.1 5 hour per record = 7 total annual hours for very small farms to 
comply with § 112.150(b)(2). For 37 small farms, it is estimated that 37 total records will be 
generated annually. Therefore , 37 records  × 0.1 5 hour per record = 6 total annual hours for small 
farms to comply with § 112.150(b)(2). For 94 large farms, it is estimated that 94 total records 
will be generated annually. Therefore, 94 records  × 0.1 5 hour per record = 14 total annual hours 
for very small farms to comply with § 112.150(b)(2).   
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  Section 112.150(b)(3) requires the documentation of the written sampling plan for each 
production batch of sprouts in accordance with § 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 eac h 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  × 1 hour = 177 annual hours for sprout farms 
to comply with § 112.150(b)(3).   
Section 112.150(b)(4) requires records of all testing conducted in accordance with the 
requirements of § 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 § 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 opera tions  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  × 1.5 to account for the uncertainty associated with applicability 
of testing requirements for additional pathogens). Therefore, 2,498  × 0.1 5 = 375 annual hours for 
very small sprouting operations  to comply with § 112.150(b)(4).  For 27 small sprouting 
operations  it is estimated that 2,025 total records will be generated annu ally (or an average of 
about 49.6 per sprouting operation  × 1.5 to account for the uncertainty associated with 
applicability of testing requirements for additional pathogens). Therefore, 2,025 records  × 0.1 5 
hour per record = 304 annual hours for small spr outing operations  to comply with § 
112.150(b)(4) with respect to testing for E. coli O157:H7 and Salmonella and other pathogens as  
679 
 applicable.  For 68 large sprouting operations  it is estimated that 22,689 total records will be 
generated annually (or an ave rage of about 222.6 per sprouting operation  × 1.5 to account for the 
uncertainty associated with applicability of testing requirements for additional pathogens). 
Therefore, 22,689 records  × 0.1 5 hour per record = 3,403 annual hours for large sprouting 
operations  to comply with § 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 §§ 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 es timated 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 estimat ed 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  × 0.1 7 hour per record = 340 total annual hours for 
small sprouting  operations  to comply with § 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, 3,2 40 records  × 0.1 7 
hour per record = 551 total annual hours for small farms to comply with § 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  × 0.1 7 hour per record = 2,079 total annual hours for large 
sprouting operations  to comply with § 112.150(b)(4) with respect to testing for Listeria  spp. or L. 
monocytogenes .   
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 Section 112.150(b)(6) requires records of corrective actions conducted in accordance 
with the requirements of §§ 112.142(b)(2), 112.146, and 112.148 for sprouting operations. It is 
estimated that all sprouting operations may collectively pe rform 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 fa rms × 0.5 hour = 143 annual hours for sprout farms to comply 
with § 112.150(b)(6).   
Commercial processing exemption recordkeeping  
Under § 112.2(b)(4), farms relying on the commercial processing exemption must 
establish and maintain records of their require d 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 § 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  × an 
additional 10 percent to account for covered farms relying on this exemption for only some of 
their pr oduce, 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  × 
0.08 hour per entity = 365 annual hours to comply with § 112.2(b)(4).  
Table 32.-- Estimated Annual Recordkeeping Burden  
One-Time Hourly Burden  
21 CFR  No. Of 
Recordkeepers  No. of 
Records  Total 
Records  Average 
Hourly 
Burden  Total 
Hours  Operating 
Costs in 
millions 
(related to 
testing 
burdens)  
Agricultural Water —Documentation of Scientific Data  
112.50(b)(3)  5,547  1 5,547  0.5 2,773     
681 
 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 Small 
Farms  46 1 46 7.0 321   
112.150(b)(2), Small farms  37 1 37 12.0 446   
112.150(b)(2), Large farms  94 1 94 17.0 1,592    
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 Hourly Burden  20,484  N/A 
Annual Hourly Burden  
21 CFR  No. of 
Recordkeepers  No of 
Records  Total 
Annual 
Records  Avg. 
Hourly 
Burden  Total 
Hours  Operating 
Costs (in 
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   
682 
 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    
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     
683 
 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 worker 
tools, very small farms  16,061  1 16,061  8.0 128,485    
112.140(b)(1) Cleaning worker 
tools, small and large farms  8,635  1 8,635  25.0 215,871    
112.140(b)(1) Cleaning 
machinery, very small farms  13,156  1 13,156  8.0 105,248    
112.140(b)(1) Cleaning 
machinery, small and large 
farms  7,073  1 7,073  25.0 176,831    
Testing Requirements for Sprouts  
Testing for E. coli and 
Salmonella  and additional 
pathogens as applicable              
112.144(b) and (c), 112.147, 
very small farms  33 125 4,163  0.50 2,081   $0.15  
112.144(b) and (c), 112.147, 
small farms  27 125 3,375  0.50 1,688   $0.12  
112.144(b) and (c), 112.147, 
large farms  68 558 37,882  0.50 18,941   $1.37  
Testing for Listeria  spp. or L. 
monocytogenes              
112.144(a), 112.145, very small 
farms  33 60 1,998  0.15 300  $0.02  
112.144(a), 112.145, small 
farms  27 120 3,240  0.15 486  $0.04  
112.144(a), 112.145, large 
farms  68 180 12,231  0.15 1,835   $0.13  
Recordkeeping Related to Sprouts  
Documentation of Treatment of 
Seeds or Beans              
112.150(b)(1), very small farms  33 50 1,665  0.20 333   
112.150(b)(1), small farms  27 50 1,350  0.20 270   
112.150(b)(1), large farms  68 223 15,153  0.20 3,031    
Environmental Monitoring Plan 
- Updating              
112.150(b)(2), very small farms  46 1 46 0.15 7   
112.150(b)(2), small farms  37 1 37 0.15 6   
112.150(b)(2), large farms  94 1 94 0.15 14    
684 
 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 small farms  33 75 2,498  0.15 375   
112.150(b)(4), small farms  27 75 2,025  0.15 304   
112.150(b)(4), large farms  68 334 22,689  0.15 3,403    
Records of Testing for Listeria  
spp. or L. monocytogenes              
112.150(b)(4), very small farms  33 60 1,998  0.17 340   
112.150(b)(4), small farms  27 120 3,240  0.17 551   
112.150(b)(4), large farms  68 180 12,231  0.17 2,079    
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        
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 § 112.6(b) certain qualified exempt farms (those that would otherwise be covered 
by the rule but that meet the criteria in § 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 § 112.5. After subtracting the number of farms that are not covered by the 
rule because they have a nnual monetary value of produce sold of $25,000 or less, 3,285 farms 
remain that must comply with § 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  
685 
 board is 24 hours [(60 minutes  × 24)/60]. Therefore, 3,285 farms  × 24 annual hours = 78,840 
annual hours for these farms to comply with the requirement of § 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. Th erefore, 3,083  × 0.08 hour = about 247 hours to comply with § 
112.6(b).  
Under § 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 applic able 
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 es timated 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 § 112.31(b)(2), 
which will consist of the em ployer giving verbal instructions to employees.  Therefore, 29,175  × 
5 minutes = 2,334 hours to comply with § 112.31(b)(2).  
Under § 112.33(a), covered farms must make visitors aware of policies and procedures to 
protect covered produce and food -contact sur faces 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 th is provision; therefore no burden is estimated for those farms. After subtracting 
these farms, it is estimated that § 112.33(a) represents a third -party disclosure requirement for  
686 
 35,556 farms. We estimate that it will take 8 hours annually for the operato r 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 farm s × 8 hours per farm = 284,448 annual hours to comply 
with § 112.33(a).  
Under § 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 
reduc e the presence of microorganisms of public health significance.” It is estimated that § 
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, wh o would otherwise be 
subject to the rule  × 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  × 0.08 hours per entity  × 26 shipments = 9,502 annual hours to comply with § 
112.2(b)(2).  
Under § 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 § 112.2(b)(3) represents a th ird-party disclosure 
requirement for 4,568 entities (the same entities described previously regarding § 112.2(b)(2)). 
We estimate that it will take 1 hour to provide this documentation each year. Therefore, 4,568 
entities  × 1 hour per entity = 4,568 annual  hours to comply with § 112.2(b)(3).   
687 
 Under § 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 
requiremen t represents a burden to 13 sprouting operations (128  × 10 percent). We estimate that 
it will take 1 hour to provide this documentation each year. Therefore, 13 sprouting operations  × 
1 hour per sprouting operations = 13 annual hours to comply with § 112.2 (b)(3).  
Table 33.-- Estimated Third -Party Disclosure Burden  
One Time Third -Party Disclosure Burden  
21 CFR Section (Or 
FDA Form #)  No. of 
Respondents  No. of Responses 
per Respondent  Total 
Responses  Average Burden per 
Response (in hours)  Total 
Hours  
112.6(b) 
Documentation  3,083  1 3,083  0.08 247 
Total One -Time Burden  247 
Annual Third -Party Disclosure Burden  
21 CFR Section (Or 
FDA Form #)  No. of 
Respondents  No. of Responses 
per Respondent  Total Annual 
Responses  Average Burden per 
Response (in hours)  Total 
Hours  
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  
  
688 
  
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 . 
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The following references have been placed on display in the Division of Dockets 
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712 
 List of Subjects  
21 CFR Part 11  
Administrative practi ce and procedure, Computer technology, Reporting and 
recordkeeping requirements.  
21 CFR Part 16  
 Administrative practice and procedure.  
21 CFR Part 112  
Foods, Fruits and vegetables, Incorporation by reference, Packaging and containers, 
Recordkeeping requir ements, 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  
1. The a uthority citation for 21 CFR part 11 continues to read as follows:  
Authority :  21 U.S.C. 321 –393; 42 U.S.C. 262.  
2.  In § 11.1, add paragraph (k) to read as follows:  
§ 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 regul ations, remain subject to this 
part.  
* * * * *   
713 
 PART 16 --REGULATORY HEARING BEFORE THE FOOD AND DRUG 
ADMINISTRATION  
 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.  
4. Amend § 16.1 by: 
a. In paragraph (b)(1), add ing an entry in numerical order . 
b. In paragraph (b)(2), add ing an entry in numerical order . 
The additions read as follows:  
§ 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) * * *  
 §§ 112.2 01 through 112.213, (see part 112, subpart R of this chapter), relating to 
withdrawal of a qualified exemption.  
* * * * *  
 5. Add part 112 to read as follows:   
714 
 PART 112 --STANDARDS FOR THE GROWING, HARVESTING, PACKING, AND 
HOLDING OF PRODUCE FOR HUMAN CONSUM PTION  
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 e xemption 
in accordance with § 112.5?  
112.7 What records must I establish and keep if my farm is eligible for a qualified exemption in 
accordance with § 112.5?  
Subpart B --General Requirements  
112.11 What general requirements apply to persons who are subjec t 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?   
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 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 mus t 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 req uirements 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 § 
112.41 or § 112.44?  
112.46 How often must I test agricultural water that is subject to the requirements of § 112.44?  
112.47 Who must perform the te sts required under § 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 requiremen ts of this subpart?  
112.50 Under this subpart, what requirements apply regarding records?  
Subpart F --Biological Soil Amendments of Animal Origin and Human Waste   
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 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 or igin 
that I apply in the growing of covered produce?  
112.55 What microbial standards apply to the treatment processes in § 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 requireme nts 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   
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 112.111 What measures must I take if I grow, h arvest, 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 t o dropped covered produce?  
112.115 What measures must I take when packaging covered produce?  
112.116 What measures must I take when using food -packing (including food packaging) 
material?  
Subpart L --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 a pply 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?   
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 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 require ments 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 colle ct 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 reg arding records?  
Subpart N --Analytical Methods  
112.151 What methods must I use to test the quality of water to satisfy the requirements of  
§ 112.46?   
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 112.152 What methods must I use to test the growing, harvesting, packing, and holding  
environment for Liste ria species or L. monocytogenes  to satisfy the requirements of § 
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 § 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 petitio n 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?   
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 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 v ariance 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 permissi ble 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 § 112.5?  
112.202 What procedure will FDA use to withdraw an exemption?  
112.203 What information must FDA include in an order to withdr aw 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?   
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 112.209 Who is the presiding officer for an appeal and for an informal hearing?  
112.2 10 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  
§ 112.1  What food is covered by this part?  
(a) Unless it is excluded from this part under § 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 D istrict 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, ap ricots, 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 Nap a), 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), 
cowpe a beans, cress -garden, cucumbers, curly endive, currants, dandelion leaves, fennel -
Florence, garlic, genip, gooseberries, grapes, green beans, guavas, herbs (such as basil, chives,  
722 
 cilantro, oregano, and parsley), honeydew, huckleberries, Jerusalem articho kes, 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 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, su mmer 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).  
§ 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, kid ney; 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 far m 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 conditi ons:  
723 
 (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 microorganism s 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 proc essing described in paragraph (b)(1) of this section and 
that the customer:   
724 
 (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 microorgani sms 
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 signific ance; 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 t he 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 paragraph s (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 parag raph (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 § 112.2(b)(3)(i) or (ii) must act 
consistently with the assurance and document  its actions taken to satisfy the written assurance.  
§ 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.    
725 
 (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 p art 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 che mical 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.   
726 
  Agricultural tea additive  means a nutrient source (such as molasses, yea st 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 surface s, 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 (includin g water used for washing or cooling 
harvested produce and water used for preventing dehydration of covered produce).  
 Animal excreta  means solid or liquid animal waste.  
 Application interval  means the time interval between application of an agricultural input 
(such as a biological soil amendment of animal origin) to a growing area and harvest of covered 
produce from the growing area where the agricultural input was applied.  
 Biological soil amendment  means any soil amendment containing biological materials 
such as 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 un der thermophilic conditions for a designated  
727 
 period of time (for example, 3 days) at a designated temperature (for example, 131 °F (55 °C)), 
followed by a curing stage under cooler conditions.  
 Covered activity  means growing, harvesting, packing, or holdi ng 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 § 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 §§ 112.1 and 112.2.  The term “covered produce” refers to the harvestable or 
harvested part of the cro p.   
 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, prom ote 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  
728 
 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 far m 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 ad ditional 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/proc essing is irradiation); or   
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  (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 A ctivities Farm. A Secondary Activities Farm may also conduct those 
additional activities allowed on a Primary Production Farm in paragraph s (i)(B) and ( C) of this 
definition.  
 Food  means food as defined in section 201(f) of the Federal Food, Drug, and Cosm etic 
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 occur s 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 aq uifers, 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  
730 
 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 proc essed 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 2 01(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 agricultural 
commodi ties 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 ha y 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.    
731 
  Know n 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, treati ng, 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 cau se 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 regi stered.  An example of such a facility is a “farm  
732 
 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 pla nned 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 ma nure) 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 ag ricultural 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 sortin g, 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 fo od 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 origi n, 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 gener ated by farms, packing 
houses, canning operations, wholesale distribution centers and grocery stores; products that have  
733 
 been removed from their packaging (such as out -of-date juice, vegetables, condiments, and 
bread); and associated packaging that is vege tative 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 resta urants.  
 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 n ut (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 
growin g unit (e.g., a single drum or bin, or a single rack of trays that are connected to each  
734 
 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).  
 Qual ified 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 § 1.227) that is located:  
 (i) In the same State or t he 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 effective in 
destroying vegetative cells of microorganisms of public health significance, and in substantially 
reducing numbers of other undesirable microorganisms, but without adv ersely 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, tabl e 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 gro wth media that serve as the entire substrate during the growth of 
covered produce (such as mushrooms and some sprouts).   
735 
  Spent sprout irrigation water  means water that has been used in the growing of sprouts.  
 Stabilized compost  means a stabilized (i.e., f inished) 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 wit h 
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 o f 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 at mosphere (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 sourc e 
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 a ir 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 th e 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.   
736 
  Water distribution system  means a system to carry water from its pr imary 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.  
§ 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 § 112.3(c)) sold 
during the previous 3 -year period of more than $25,000 (on a rolling b asis), 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 § 112.5 and we have 
not withdrawn the farm’s exemption in accordance with the requirements of subpart R 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?   
737 
 (a) A farm is eligible for a qualified exemption and associated modified requirements in a 
calendar year if:  
 (1) During t he previous 3 -year period preceding the applicable calendar year, the average 
annual monetary value of the food (as defined in § 112.3(c)) the farm sold directly to qualified 
end-users (as defined in § 112.3(c)) during such period exceeded the average annu al 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 § 112.3(c)) the farm 
sold during the 3 -year period preceding the applicable calendar year was less th an $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.  
§ 112.6  What modified requirements apply to me if my farm is eligible for a qualified 
exemption in accordance with § 112.5?  
(a) If your farm is eligible for a qualified exemption in accordance wi th § 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  
738 
 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 se ction 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.  
§ 112.7  What records must I establish and keep if my farm is eligible for a qualified exempt ion 
in accordance with § 112.5?  
If your farm is eligible for a qualified exemption in accordance with § 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 § 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 § 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 § 112.5, including a 
written record reflecting that you have performed an annual review and veri fication of your 
farm’s continued eligibility for the qualified exemption.   
739 
 Subpart B --General Requirements  
§ 112.11  What general requirements apply to persons who are subject to this part?  
You must take appropriate measures to minimize the risk of seriou s 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 as surances that the produce is not 
adulterated under section 402 of the Federal Food, Drug, and Cosmetic Act on account of such 
hazards.  
§ 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 § 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 alt ernative 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 infor mation on which you rely in accordance with the  
740 
 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 Qual ifications and Training  
§ 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 
thereo f, 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 mus t 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 su bparts 
C through O of this part.   
§ 112.22  What minimum requirements apply for training personnel who conduct a covered 
activity?   
741 
 (a) At a minimum, all personnel who handle (contact) covered produce during covered 
activities or supervise the conduct of s uch 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 conditi on 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 th e 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 ma y 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 know n 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.   
742 
 § 112.23  What requirements a pply 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.  
§ 112.30  Under this subpart, what requirements apply regarding record s? 
(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 tr aining, topics covered, and the persons(s) trained.  
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?  
(a) You must tak e 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).  
(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 i n 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 appe ars to have, an applicable health condition, until the 
person’s health condition no longer presents a risk to public health; and   
743 
  (2) Instructing personnel to notify their supervisor(s) (or a responsible party) if they have, 
or if there is a reasonable po ssibility that they have an applicable health condition.  
§ 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 fo reseeable 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 c ontact 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 othe r effective 
surfactant) and running water that satisfies the requirements of § 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;    
744 
  (v) As soon as practical after touching anima ls (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 jewel ry 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).  
§ 112.33  What measures must I take to prevent visitors from contaminating covered produce 
and fo od 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  
§ 112.41  What requirements apply to the quality of agricultural water?  
All agricul tural water must be safe and of adequate sanitary quality for its intended use.  
§ 112.42  What requirements apply to my agricultural water sources, water distribution system, 
and pooling of water?   
745 
 (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 like ly 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 i ntroduction 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 a re 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 inspecti ng 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 an y conditions that are reasonably likely to introduce known or reasonably 
foreseeable hazards into or onto covered produce or food contact surfaces; correcting any  
746 
 significant deficiencies (e.g., repairs to well cap, well casing, sanitary seals, piping tank s 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 circumstanc es. 
(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.  F or example, such 
measures may include using protective barriers or staking to keep covered produce from 
touching the ground or using an alternative irrigation method.  
§ 112.43  What requirements apply to treating agricultural water?  
(a) When agricultural w ater is treated in accordance with § 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 
the relevant microbial quality criteria in §  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 § 112.44, as applicable.  
 (b) You must monito r 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 § 112.44, as appl icable.   
747 
 § 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 Esch erichia 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 c overed 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 § 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).   
748 
 § 112.45 What measures must I take if my agricultural water does not meet the requirements of 
§ 112.41 or § 112.44?  
(a) If you have determined or have reason to believe that your agricultural water is no t 
safe or of adequate sanitary quality for its intended use as required under § 112.41 and/or if your 
agricultural water does not meet the microbial quality criterion for the specified purposes as 
required under § 112.44(a), you must immediately discontinu e 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 t hat 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, adequat ely ensure that your agricultural water meets the microbial quality criterion in 
§ 112.44(a); or  
(2) Treat the water in accordance with the requirements of § 112.43.  
(b) If you have determined that your agricultural water does not meet the microbial 
quali ty criteria (or any alternative microbial quality criteria, if applicable) required under 
§ 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) a nd/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 th reshold value (STV) to meet the microbial quality  
749 
 criteria in § 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 acco mpanying maximum time interval, 
in accordance with § 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 
reducti on using appropriate microbial removal rates during activities such as commercial 
washing, to meet the microbial quality criteria in § 112.44(b) (or any alternative microbial 
criteria, if applicable), and any accompanying maximum time interval or log reduc tion, 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 reaso nably 
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 c riteria in § 112.44(b) (or any 
alternative microbial criteria, if applicable); or  
(3) Treat the water in accordance with the requirements of § 112.43.  
§ 112.46  How often must I test agricultural water that is subject to the requirements of §  112.44?  
(a) There is no requirement to test any agricultural water that is subject to the 
requirements of § 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  
750 
 141.2) approved to administer the SDWA public water supply program, and you have Public 
Water System results or certificates of c ompliance 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 § 112.44(a), and you have public water system results 
or cert ificates of compliance that demonstrate that the water meets that requirement; or  
 (3) You treat water in accordance with the requirements of § 112.43.  
(b) Except as provided in paragraph (a) of this section, you must take the following steps 
for each sou rce of water used for purposes that are subject to the requirements of § 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 untreat ed 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 § 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.  
(ii) The samples of agricultural water must be representative of your use of the water and 
must be collecte d 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 § 112.45(b).   
751 
 (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 initia l 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) F or 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 § 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 va lues 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 sam ples 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 § 112.45(b).  
(3) If you have determined or have reason t o 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  
752 
 water source), you mus t 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 curr ent 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 mo dify your water use based on the new GM and STV values in your new 
microbial water quality profile in accordance with § 112.45(b).  
(c) If you use untreated ground water for the purposes that are subject to the requirements 
of § 112.44(a), you must initiall y 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 § 112.45(a). If your four initial sample results meet the microbial quality criteria of 
§ 112.44(a), you may test once annually thereafter, using a minimum of on e 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 § 112.44(a).  
§ 112.47 Who must perform the tests requi red under § 112.46 and what methods must be used?  
(a) You may meet the requirements related to agricultural water testing required under 
§ 112.46 using:  
(1) Test results from your agricultural water source(s) performed by you, or by a person 
or entity act ing on your behalf; or   
753 
 (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 § 112.151.  
§ 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 activi ties 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 ma intain 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.  
§ 112.49 What alternatives may I establish and use in lieu of the requirements of this subpart?  
Provided you satisfy the requirements of § 112.12, you may establish and use one or 
more of the following alternatives:   
754 
 (a) An  alternative microbial quality criterion (or criteria) using an appropriate indicator of 
fecal contamination, in lieu of the microbial quality criteria in § 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 § 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 
§ 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 
§ 112.46(b)(2)(i)(A).  
§ 112.50  Under this subpart, what requirement s 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 § 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 r ely on to support the adequacy of a method used to 
satisfy the requirements of § 112.43(a)(1) and (2);  
 (4) Documentation of the results of water treatment monitoring under § 112.43(b);  
 (5) Scientific data or information you rely on to support the microbi al die -off or removal 
rate(s) that you used to determine the time interval (in days) between harvest and end of storage,  
755 
 including other activities such as commercial washing, as applicable, used to achieve the 
calculated log reduction of generic Escherich ia coli (E. coli), in accordance with § 
112.45(b)(1)(ii);  
 (6) Documentation of actions you take in accordance with § 112.45. With respect to any 
time interval or (calculated) log reduction applied in accordance with § 112.45(b)(1)(i) and/or 
(ii), such do cumentation 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 § 112.46(a)(1) or (2), if applicable;  
(8) Scientific data or information y ou rely on to support any alternative that you establish 
and use in accordance with § 112.49; and  
(9) Any analytical methods you use in lieu of the method that is incorporated by 
reference in § 112.151(a).  
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?  
(a) A biological soil amendment of animal origin is treated if it has been processed to 
completion to adequately reduce micr oorganisms of public health significance in accordance 
with the requirements of § 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  
756 
 not u ntreated 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 
§ 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 cont ains 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.  
§ 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 c ontaminated by an 
untreated or in -process biological soil amendment of animal origin.   
757 
 (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 un treated.  
§ 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.  
§ 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 ani mal 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 
§ 112.56:  
(a) A scientifically valid controlled physical process (e.g., therma l), 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 § 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 bio logical processes, 
that has been validated to satisfy the microbial standard in § 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  § 112.55(b) include:   
758 
 (1) Static composting that maintains aerobic ( i.e., oxygenated) conditions at a minimum 
of 131 °F (55 °C) for 3 consecutive days and is followed by adequate curing; and  
(2) Turned composting that maintains aerobic conditions at a mini mum of 131 °F (55 °C) 
for 15 days (which do not have to be consecutive), with a minimum of five turnings, and is 
followed by adequate curing.  
§ 112.55 What microbial standards apply to the treatment processes in § 112.54?  
The following microbial standards apply to the treatment processes in § 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.  
(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 sol ids (dry weight basis).  
§ 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  
759 
 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). 
If the biological soil amendment of 
animal origin is -- Then the biological soil 
amendment of animal origin must  
be applied -- And then the  
minimum application  
interval is -- 
(1)(i) Untreated  
 In a manner that does not contact 
covered produce during application 
and minimizes the potential for 
contact with covered produce after 
application  [Reserved]  
 
(ii) Untreated  
 In a manner that does not contact 
covered produce during or after 
application  0 days  
 
(2) Treated by a scientifically valid 
controlled physical, chemical, or 
biological process, or combination 
of scientifically valid controlled 
physical, chemical, and/or biological 
processes, in accordance with the 
requirements of § 112.54(b) to meet 
the microbial standard in 
§ 112.55(b).  In a manner that minimizes  the 
potential for contact with covered 
produce during and after application  
 0 days  
 
(3) Treated by a scientifically valid 
controlled physical, chemical, or 
biological process, or combination 
of scientifically valid controlled 
physical, chemical, or biol ogical 
processes, in accordance with the 
requirements of § 112.54(a) to meet 
the microbial standard in 
§ 112.55(a).  In any manner ( i.e., no restrictions)  
 0 days  
 
 
(b) [Reserved]  
§ 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 trea ted biological soil amendment of animal origin you receive from a third 
party, documentation (such as a Certificate of Conformance) at least annually that:   
760 
 (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 pro cess 
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  
§ 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.  
§ 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 th e 
circumstances there is a reasonable probability that grazing animals, working animals, or animal 
intrusion will contaminate covered produce.   
761 
 (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); a nd  
(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 § 112.112 and ta ke 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.  
§ 112.84  Does this reg ulation 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 habita t or otherwise clear farm 
borders around outdoor growing areas or drainages.  
Subpart J --[Reserved]  
Subpart K --Growing, Harvesting, Packing, and Holding Activities   
762 
 § 112.111  What measures must I take if I grow, harvest, pack or hold both covered and exclud ed 
produce?   
 If you grow, harvest, pack or hold produce that is not covered in this part (i.e., excluded 
produce in accordance with § 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 di stribution); 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.  
§ 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 vi sibly 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 g rowing area and all covered produce to be 
harvested, regardless of the harvest method used.   
§ 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.   
763 
 § 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).  
§ 112.115  What measures must I take when packaging covered produce?  
You must package covered produce in a manner that prevents the forma tion of 
Clostridium  botulinum  toxin if such toxin is a known or reasonably foreseeable hazard (such as 
for mushrooms).  
§ 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  
§ 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  
764 
 publi c 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).  
§ 112.122  What buildings are subject to the requirements of thi s 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).  
§ 112.123  What general requirements apply regarding equipment and tools subject to this 
subpart?  
All of the following requirements apply regar ding 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) In stalled 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 too ls from attracting 
and harboring pests.   
765 
  (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 th e 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 nec essary to protect against contamination of covered produce.  
 (2) You must maintain and clean all non -food-contact surfaces of equipment and tools 
subject to this subpart used during harvesting, packing, and holding as frequently as reasonably 
necessary to  protect against contamination of covered produce.  
(e) If you use equipment such as pallets, forklifts, tractors, and vehicles such that they are 
intended to, or likely to, contact covered produce, you must do so in a manner that minimizes the 
potential fo r contamination of covered produce or food contact surfaces with known or 
reasonably foreseeable hazards.  
§ 112.124  What requirements apply to instruments and controls used to measure, regulate, or 
record?  
Instruments or controls you use to measure, regu late, 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.  
§ 112.125  What requirements apply to equipment that is subject to this subpart used in the 
transport of covered produce?   
766 
 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.  
§ 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 conta mination 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 like ly 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   
767 
 (2) Drip or condensate.  
§ 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 pro duce, 
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 con tact 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.  
§ 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).  
§ 112.129  What requirements apply to toilet facilities?   
768 
 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) Pro vide 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 clo se proximity to toilet facilities to make it practical for persons who use the toilet 
facility to wash their hands.  
§ 112.130  What requirements apply for hand -washing facilities?    
All of the following requirements apply to hand -washing facilities:  
(a) Y ou 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 § 112.44(a) for water used to wash 
hands; and   
769 
  (3) Adequate drying devices (such as single service towels, sanitary towel service, or 
elect ric 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 fro m 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.  
§ 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 sewa ge 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 agric ultural water distribution systems with known or reasonably 
foreseeable hazards.  
(c) You must manage and dispose of leakages or spills of human waste in a manner that 
prevents contamination of covered produce, and prevents or minimizes contamination of foo d 
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 mu st take appropriate steps to ensure that sewage and  
770 
 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 distri bution systems.  
§ 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 a ctivities:  
(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 p otential source of contamination in areas used for a covered activity.  
§ 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 t o covered produce, food contact surfaces, 
areas used for a covered activity, or agricultural water sources; and   
771 
 (d) Not allow backflow from, or cross connection between, piping systems that discharge 
waste water or sewage and piping systems that carry wate r used for a covered activity, for 
sanitary operations, or for use in hand -washing facilities.  
§ 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 prev ent 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]  
§ 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 requiremen ts 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 holdin g activities.  
Subpart M --Sprouts  
§ 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 r oots.  
§ 112.142  What requirements apply to seeds or beans used to grow sprouts?   
772 
 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 bean s 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 § 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, distr ibutor, 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 p aragraph (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 paragraph s (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).   
773 
 (d) You must visually examine seeds and beans, and packaging used to ship seeds or 
beans, for signs of potential contami nation 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.  
§ 112.143  What measures must I take for growing, ha rvesting, 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 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 § 112.144.   
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 (d) You must establish and implement a written environmental monitoring plan as 
specified in § 112.145.  
(e) You must take certain actions if you detect Listeria  species or L. monocytogenes  in 
the growing, harvesting, pac king, or holding environment, as specified in § 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 § 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 § 112.148.  
§ 112.144  What testing must I do during growing, harvesting, packing, and holding sprouts?  
All of the following testing must be done during growing, harve sting, 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 § 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 § 112.147; or  
 (2) If tes ting 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 § 112.147.   
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  (c) In addition to E. coli O157:H7 and Salmonella  species, you must cond uct 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, o r 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).   
§ 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 les s 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 c ontact surfaces  
776 
 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 § 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 § 112.146, and details when and how you 
will accomplish those actions, if the growing, harvesting, packing, or hold ing environment tests 
positive 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?  
You must, at a minimum, take t he 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 samp ling 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 appr opriate action to prevent any food that is adulterated under section 402 of 
the Federal Food, Drug, and Cosmetic Act from entering into commerce.   
777 
 § 112.147  What must I do to collect and test samples of spent sprout  irrigation water or sprouts 
for pathoge ns?  
All of the following requirements apply for collecting and testing samples of spent sprout 
irrigation water or sprouts for pathogens as required in § 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 wit h 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 § 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 § 112.14 4(c).  
(c) Your written sampling plan must include a corrective action plan that at a minimum, 
requires you to take the actions in § 112.148, and details when and how you will accomplish 
those actions, if the samples of spent sprout irrigation water or spr outs test positive for E. coli 
O157:H7, Salmonella  species, or a pathogen meeting the criteria in § 112.144(c).  
§ 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 mini mum, 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 § 112.144(c):   
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 (a) Take appropriate action to prevent any food that is ad ulterated under section 402 of 
the Federal Food, Drug, and Cosmetic Act from entering into commerce;   
(b) Take the steps required in § 112.142(b) with respect to the lot of seeds or beans used 
to grow the affected production batch of sprouts (except as al lowed under §  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.  
§ 112.150  Under this subpart, what requirements apply regarding reco rds? 
(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 signi ficance and are appropriately handled and packaged 
following the treatment, in accordance with the requirements of § 112.142(e);  
 (2) Your written environmental monitoring plan in accordance with the requirements of § 
112.145;  
 (3) Your written sampling plan for each production batch of sprouts in accordance with 
the requirements of § 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 §§ 112.152 and 112.153; and   
779 
 (6) Documentation of actions you take in accordance with §§ 112.142(b) and (c), 
112.146, and 112.148.  
Subpart N --Analytical Methods  
§ 112.151  What methods must I use to test the quality of water to satisfy the requirements of 
§ 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 M embrane 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 sc ientifically valid method that is at least equivalent to the method of analysis in 
§ 112.151(a) in accuracy, precision, and sensitivity; or  
(2) For any other indicator of fecal contamination you may test for pursuant to § 
112.49(a), a scientifically valid  method.   
780 
 § 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 
§ 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 i nspect 
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.go v/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 
§ 112.152(a) in accuracy, precision, and sensitivity.  
§ 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 § 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:   
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 (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 Nat ional 
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 v alid method that is at least equivalent to the method of analysis in § 
112.153(a)(1) in accuracy, precision, and sensitivity; and  
(b) For any other pathogen(s) meeting the criteria in § 112.144(c), a scientifically valid 
method.   
Subpart O --Records  
§ 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 observat ions obtained during monitoring;   
782 
  (iii) An adequate description (such as the commodity name, or the specific variety or 
brand name of a commodity, and, when available, any lot number or other identifier) of covered 
produce applicable to the record;  
 (iv) The location of a growing area (for example, a specific field) or other area (for 
example, a specific packing shed) applicable to the record; and  
 (v) The date and time of the activity documented;  
 (2) Be created at the time an activity is performed or observed;  
 (3) Be accurate, legible, and indelible; and  
 (4) Be dated, and signed or initialed by the person who performed the activity 
documented.  
 (b) Records required under §§ 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.  
§ 112.162  Where must I st ore 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 on site location at your farm.  
§ 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  
783 
 supplemented as necessary to include all of the required information and satisfy the requirements 
of this part.  
(b) The inform ation 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.  
§ 112.1 64  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 th e criteria for a qualified exemption, in accordance with §§ 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 process es 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 r ecords related to analyses, sampling, or action plans, is  
discontinued.  
§ 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   
784 
 (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 § 11.3(b)(6) of th is 
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.  
§ 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 reduc tion 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 rea sonably accessible location but must be returned to your farm within 24 hours for 
official review upon request.  
§ 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  
§ 112.171  Who may request a variance from the requirements of this part?   
785 
 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, proc esses, 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 
requir ements of this part.  
§ 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 § 10.30 of this chapter.  
§ 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 § 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 condit ions 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 publi c health protection as the requirements of this part;   
786 
 (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 informatio n 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.  
§ 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 sub mitted 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.   
§ 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, Offic e of Compliance, CFSAN, responds to a request for a variance.  
§ 112.176  What process applies to a petition requesting a variance?  
(a) In general, the procedures set forth in § 10.30 of this chapter govern our response to a 
petition requesting a variance.  
(b) Under § 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 g ranted (e.g., because 
their farm is covered by the petition or as a person similarly situated to persons covered by the 
petition).   
787 
 (c) Under § 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 publ ic, and periodically update, a list of filed 
petitions requesting variances, including the status of each petition (for example, pending, 
granted, or denied).  
§ 112.177  Can an approved variance apply to any person other than those identified in the 
petiti on 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 reques t that the variance be applied to its similarly situated 
persons by submitting comments in accordance with § 10.30 of this chapter.  These comments 
must include the information required in § 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 §§ 112.172 and 112.173.   
788 
 (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 an nouncing our decision to apply the variance to similarly 
situated persons in that particular location.  
§ 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 r equired under 
§ 112.173 (including the requirements of § 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.  
§ 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.  
§ 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.   
789 
 § 112.181  What procedures apply if FDA determines that an approved variance should be 
modified or revoked?  
(a) We will provide the followi ng 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, writte n 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 Feder al 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 con sider 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.   
790 
 (i) If FDA gran ts 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, t ribe, 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 conside r 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.  
§ 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 § 112.44(b);  
(b) Variance from the microbial die -off rate that is used to determine the time interval 
between last irrigation and harvest, and/or the accompan ying maximum time interval, established 
in § 112.45(b)(1)(i); and   
791 
 (c) Variance from the approach or frequency for testing water used for purposes that are 
subject to the requirements of § 112.44(b), established in § 112.46(b).  
Subpart Q --Compliance and Enf orcement  
§ 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 
Fede ral 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 g rown, 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 be come 
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).  
§ 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  
§ 112.201  Under what circumstances can FDA withdraw a qualified exemption in accordance 
with the requirements of § 112.5?   
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 (a) We may withdraw your qualified exemption under § 112.5:  
 (1) In the event of an active investi gation 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 cha rge 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 notif ication, 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.  
§ 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 ap prove an order to withdraw 
the exemption before the order is issued.   
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 (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.  
§ 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 § 112.5 must 
include the following information:  
(a) The date of the order;  
(b) The name, address and loc ation 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 tha t 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   
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 (2) Appeal the order within 15 calendar days of the date of receipt of the order in 
accordance with the requirements of § 112.206.  
(e) A statement that a farm may request that FDA rei nstate an exemption that was 
withdrawn by following the procedures in § 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 con ducted as 
a regulatory hearing under part 16 of this chapter, with certain exceptions described in 
§ 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 Directo r 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.  
§ 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 § 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 g rowing 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; or   
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  (b) Appeal the order within 15 calendar days o f the date of receipt of the order in 
accordance with the requirements of § 112.206.   
§ 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 intere st. 
(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 d ate 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, su bmitted 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 §§ 112.6 and 112.7.  
§ 112.206  What is t he procedure for submitting an appeal?  
(a) To appeal an order to withdraw a qualified exemption applicable to a farm under 
§ 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  
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 for Food Safety and Applied Nutrition), at the mailing address, email address, or facsimile 
number identified in the order within 1 5 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 w ritten appeal of the order withdrawing an exemption provided under § 112.5, 
the owner, operator, or agent in charge of the farm may include a written request for an informal 
hearing as provided in § 112.207.   
§ 112.207  What is the procedure for requestin g 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 togeth er with its written appeal 
submitted in accordance with § 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.  
§ 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:   
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 (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 subp art 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 § 112.5, rather than the notice under 
§ 16.22(a) of this chapte r, provides notice of the opportunity for a hearing under this section and 
is part of the administrative record of the regulatory hearing under § 16.80(a) of this chapter.  
 (2) A request for a hearing under this subpart must be addressed to the FDA Distri ct 
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 § 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 inc lude 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.    
798 
  (5) Secti on 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 § 112.208(c)(4) are part of the administrative record.  
 (6) No party shall have the right, under § 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 § 16.95(b) does not apply to a hearing under 
this subpart.  With respect to a regulatory he aring under this subpart, the administrative record of 
the hearing specified in §§ 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 revie w under § 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.  
§ 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.  
§ 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:   
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  (1) If FDA grants the request for a hearing and the hearing is held, the presiding officer 
must provide a 2 calendar day opportunity for the hearing p articipants to review and submit 
comments on the report of the hearing under § 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 iss ue a final 
decision on the appeal confirming or revoking the withdrawal within 10 calendar days after the 
date the appeal is filed.  
§ 112.211  When is an order to withdraw a qualified exemption applicable to a farm revoked?  
An order to withdraw a qualifie d exemption applicable to a farm under § 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 con firm 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 f or 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 conside red a final 
Agency action for purposes of 5 U.S.C. 702.   
800 
 § 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 f ood 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 qual ified 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 o f 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 § 112.201(a)(1) and FDA later 
determines, after finishing the active investigation of a foodborne illness outbreak, that the  
801 
 outbreak is not directly linked to your farm, FDA will reinstate your qualified exemption under 
§ 112.5, and FDA will notify you in writing that your e xempt status has been reinstated.   
(d) If your qualified exemption was withdrawn under § 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 § 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: 11/13/2015 8:45 am; Publication Date:  11/27/2015]