This document is scheduled to be published in the
Federal Register on 01/16/2013 and available online at 
http://federalregister.gov/a/2013-00123
, 
and on 
FDsys.gov
4160-01-P 
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Parts 16 and 112 [Docket No. FDA-2011-N-0921] RIN 0910-AG35 Standards for the Growing, Harvesting, P acking, and Holding of Produce for Human 
Consumption AGENCY:  Food and Drug Administration, HHS.  ACTION:  Proposed rule. SUMMARY:  To minimize the risk of serious a dverse health conseque nces or death from 
consumption of contaminated produce, the Food  and Drug Administration (FDA) is proposing to 
establish science-based minimum standards fo r the safe growing, harvesting, packing, and 
holding of produce, meaning fruits and vegeta bles grown for human consumption.  FDA is 
proposing these standards as part of our implem entation of the FDA Food Safety Modernization 
Act (FSMA).  These standards would not apply to  produce that is rarely consumed raw, produce 
for personal or on-farm consumption, or produce th at is not a raw agricultural commodity.  In 
addition, produce that receives commercial proces sing that adequately reduces the presence of 
microorganisms of public health  significance would be eligib le for exemption from the 
requirements of this rule.  The proposed rule woul d set forth procedures, processes, and practices 
that minimize the risk of serious adverse he alth consequences or death, including those 
reasonably necessary to preven t the introduction of known or r easonably foreseeable biological 
hazards into or onto produce and to provide r easonable assurances that the produce is not 2 
 
adulterated on account of such hazards. We exp ect that the proposed rule, if finalized as 
proposed, would reduce foodborne il lness associated with the c onsumption of contaminated 
produce. DATES: Submit either electronic or written comments on the proposed rule byMay 16, 2013.  
Submit comments on information collection is sues under the Paperwork Reduction Act of 1995 
by February 15, 2013 (see the “Paperwork Reducti on Act of 1995” section of this document). 
ADDRESSES: You may submit comments, iden tified by Docket No. FDA-2011-N-0921 and/or 
Regulatory Information Number  RIN 0910-AG35, by any of the following methods, except that 
comments on information collection issues under the Paperwork Reduction Act of 1995 must be 
submitted to the Office of Regulatory Affairs,  Office of Management and Budget (OMB) (see 
the “Paperwork Reduction Act of 1995” section of this document). Electronic Submissions
 
Submit electronic comments in the following way: 
• Federal eRulemaking Portal:  http://www.regulations.gov . Follow the instructions for 
submitting comments. 
Written Submissions  
Submit written submissions in the following ways: 
• Mail/Hand delivery/Courier (for paper or CD -ROM submissions):  Division of Dockets 
Management (HFA-305), Food and Drug Admi nistration, 5630 Fishers Lane, rm. 1061, 
Rockville, MD  20852. 
Instructions :  All submissions received must include  the Agency name and Docket No. FDA-
2011-N-0921 and Regulatory Information Number RIN 0910-AG35 for this rulemaking. All comments received may be posted without chan ge to http://www.regulations.gov, including any 3 
 
personal information provided. For additional information on submitting comments, see the 
“Comments” heading of the SUPPLEMENTARY INFORMATION section of this document. 
Docket :  For access to the docket to read background documents or comments received, 
go to http://www.regulations.gov  and insert the docket number(s ), found in brackets in the 
heading of this document, into the “Search ” box and follow the prompts and/or go to the 
Division of Dockets Management, 5630 Fish ers Lane, rm. 1061, Rockville, MD  20852. 
FOR FURTHER INFORMATION C ONTACT: Samir Assar, Center for Food Safety and 
Applied Nutrition (HFS-317), Food and Drug Admi nistration, 5100 Paint Branch Pkwy., College 
Park, MD 20740, 240-402-1636.   SUPPLEMENTARY INFORMATION: Table of Contents
 
EXECUTIVE SUMMARY PROPOSED RULE 
I. INTRODUCTION 
A. Contamination with Microbiological Hazards 
B. Contamination with Chemical, Physical or Radiological Hazards 
II. EFFORTS TO ADDRESS PRODUCE SAFETY 
A. Inspections and Investigations 
B. Guidance documents and letters to industry 
C. Produce Safety Action Plan 
D. Public hearings 
E. Partnerships and collaborations 
F. Current industry practices 4 
 
G. 2010 Federal Register  Notice and Preliminary Stakeholder Comments 
H. White House Food Safety Working Group 
I. Other related issues 
III. LEGAL AUTHORITY 
A. Section 105 of FSMA and Sec tion 419 of the FD&C Act 
B. Other Provisions of the FD&C Act 
C. The Public Health Service Act 
D. Legal Authority for Records Requirements 
E. Intrastate Activities 
F. Relevance of Section 415 of the FD&C Act to “Farm” Definition and Related 
Definitions 
IV. REGULATORY APPROACH 
A. Qualitative assessment of risk 
B. Focus on biological hazards 
C. Consideration of differing risk of different commodities and practices 
D. Framework of the rule 
E. Records 
F. Farm-specific food safety plans 
G. Foreign farms 
H. Consistency with Codex guidelines 
I. Product testing as a strategy to control pathogens 
J. Effective dates 
K. Compliance dates 5 
 
V. THE PROPOSAL 
A. Subpart A – General provisions 
B. Subpart B – General requirements 
C. Subpart C – Standards directed to personnel qualifications and training 
D. Subpart D – Standards directed to health and hygiene 
E. Subpart E – Standards direct ed to agricultural water 
F. Subpart F – Standards directed to biologica l soil amendments of animal origin and 
human waste 
G. Reserved  
H. Reserved 
I. Subpart I – Standards directed to  domesticated and wild animals 
J. Reserved 
K. Subpart K – Standards directed to growing, harvesting, packing and holding activities  
L. Subpart L – Standards directed to equi pment, tools, buildings, and sanitation 
M. Subpart M – Standards directed to sprouts 
N. Subpart N – Analytical methods 
O. Subpart O – Requirements applying to reco rds that you must es tablish and keep 
P. Subpart P – Variances 
Q. Subpart Q – Compliance and enforcement 
R. Subpart R – Withdrawal of qualified exemption 
VI. PRELIMINARY REGULATORY IMPACT ANALYSIS VII. ANALYSIS OF ENVIRONMENTAL IMPACT  VIII. FEDERALISM  6 
 
IX. COMMENTS 
X. REFERENCES 7 
 
Executive Summary  
The FDA Food Safety Modernization Act ( FSMA) (Pub. L. 111-353) requires FDA to 
publish a notice of proposed rulemaking to establ ish science-based minimum standards for the 
safe production and harvesting of those types of fr uits and vegetables th at are raw agricultural 
commodities for which we have determined such standards minimize the risk of serious adverse health consequences or death.  Further, new section 419 also requires FDA to adopt a final 
regulation based on known safety risks, setting fort h procedures, processes, and practices that we 
determine to minimize the risk of serious advers e health consequences or death, including those 
that are reasonably necessary to prevent the in troduction of known or reasonably foreseeable 
hazards into produce and to provide reasonable as surances that produce is not adulterated under 
section 402 of the FD&C Act.   
This proposed rule focuses on microbiologi cal hazards related to produce growing, 
harvesting, packing, and holding.  We conducted a “Draft Qualitative Assessment of Risk to 
Public Health from On-Farm Contamination of  Produce” and considered the findings of this 
assessment in developing this proposed rule.  Wh ile we acknowledge the potential for chemical, 
physical or radiological contamin ation of produce, for reasons discussed in this proposed rule, 
we are not proposing specific standards for these hazards in this rulemaking. 
 
Scope of Coverage of the Proposed Rule 
 The proposed rule would apply to both do mestic and imported produce. However, as 
explained in the remainder of this document, th e proposed rule contains several exemptions:  
 8 
 
• The proposed rule would not apply to certa in specified produce commodities that are 
rarely consumed raw.   
• The proposed rule also would not apply to pr oduce that is used for personal or on-farm 
consumption, or that is not a raw agricultural commodity.   
• The proposed rule would provide an exem ption for produce that receives commercial 
processing that adequately reduces the presen ce of microorganisms (e .g. a “kill step”) as 
long as certain documentation is kept. 
• The proposed rule would not cover farms that have an average annual value of food sold 
during the previous three-year period of $25,000 or less.   
• The proposed rule would provide a qualifie d exemption and modified requirements for 
farms that meet two requirements: (1) the fa rm must have food sales averaging less than 
$500,000 per year during the last three years; and (2) the fa rm’s sales to qualified end-
users must exceed sales to others.  A qualified end-user is either (a) the consumer of the 
food or (b) a restaurant or retail food establishm ent that is located in the same State as the 
farm or not more than 275 miles away.  Inst ead, these farms would be required to include 
their name and complete business address e ither on the label of the produce that would 
otherwise be covered (if a label is requir ed under the FD&C Act and its implementing 
regulations) or at the point-of-purchase.   This exemption may be withdrawn in the event 
of an active investigatio n of an outbreak that is directly  linked to the farm, or if it is 
necessary to protect the public health and prevent or mitigate an outbreak based on conduct or conditions on the farm that are material to the safety of the produce. 
As explained in the Preamble, these entities are either exempt from all the requirements 
of the rule or are subject to a narrower set of requirements.  9 
 
 
Summary of the Major Provisi ons of the Regulatory Action 
 
The proposed rule would establish scien ce-based minimum standards for the safe 
growing, harvesting, packing, and holding of produ ce on farms. We propose new standards in the 
following major areas: 
• Worker Training and Heath and Hygiene 
o Establish qualification a nd training requirements for all personnel who handle 
(contact) covered produce or food-contact surfaces  and their supervisors 
(proposed §§ 112.21, 112.22, and 112.23);  
o Require documentation of require d training (proposed § 112.30); and 
o Establish hygienic practices and other measures needed to prevent persons, 
including visitors, from contaminati ng produce with microorganisms of public 
health significance (proposed §§ 112.31, 112.32, and 112.33). 
• Agricultural Water 
o Require that all agricultural water must be  of safe and sanitary quality for its 
intended use (proposed § 112.41).  Agricultura l water is defined in part as water 
that is intended to, or likely to, contac t the harvestable portion of covered produce 
or food-contact surfaces  (proposed § 112.3(c)); 
o Establish requirements for in spection, maintenance, and follow-up actions related 
to the use of agricultural water, wate r sources, and water distribution systems 
associated with growing, harvesting, packing, and holding of covered produce 
(proposed §§ 112.42 and 112.46);  10 
 
o Require treatment of agricultural water if  you know or have reason to believe that 
the water is not safe and of adequate  sanitary quality for its intended use, 
including requirements for treating such  water and monitoring its treatment 
(proposed § 112.43); 
o Establish specific requirements for the quality  of agricultural water that is used for 
certain specified purposes, including pr ovisions requiring periodic analytical 
testing of such water (with exemptions provided for use of public water supplies 
under certain specified conditions or trea ted water), and requiring certain actions 
to be taken when such water does not meet the quality standards (proposed §§ 
112.44 and 112.45); and provide for altern ative requirements for certain 
provisions under certain condi tions (proposed § 112.12); and 
o Require certain records, in cluding documentation of in spection findings, scientific 
data or information relied on to support the adequacy of water treatment methods, 
treatment monitoring results, water testing results, and scientific data or 
information relied on to support any pe rmitted alternatives to requirements 
(proposed § 112.50). 
• Biological Soil Amendments 
o Establish requirements for determining th e status of a biological soil amendment 
of animal origin as treated or untreat ed, and for their handling, conveying, and 
storing (proposed §§ 112.51, 112.52) 
o Prohibit the use of human waste for growing covered produce except in 
compliance with EPA regulations for su ch uses or equivalent regulatory 
requirements (proposed § 112.53); 11 
 
o Establish requirements for treatment of biological soil amendments of animal 
origin with scientifically valid, controlled, physical and/ or chemical processes or 
composting processes that satisfy certain  specific microbial standards (proposed 
§§ 112.54 and 112.55); and provide for alte rnative requirements for certain 
provisions under certain c onditions (proposed § 112.12); 
o Establish application requirements and minimum application intervals for 
untreated and treated biological soil amen dments of animal origin (proposed § 
112.56); and provide for alternative requi rements for certain provisions under 
certain conditions (proposed § 112.12); and 
o Require certain records, in cluding documentation of a pplication and harvest dates 
relevant to application intervals; do cumentation from suppliers of treated 
biological soil amendments of animal orig in, periodic test resu lts, and scientific 
data or information relied on to support a ny permitted alternativ es to requirements 
(proposed § 112.60). 
• Domesticated and Wild Animals 
o If animals are allowed to graze or are used as working animals in fields where 
covered produce is grown and under the circumstances there is a reasonable 
probability that grazing or working anim als will contaminate covered produce, 
require, at a minimum, an adequa te waiting period between grazing and 
harvesting for covered produce in an y growing area that was grazed, and 
measures to prevent the introduction of known or reasonably foreseeable hazards 
into or onto covered pr oduce (proposed § 112.82); and 12 
 
o If under the circumstances there is a reas onable probability that animal intrusion 
will contaminate covered produce, require m onitoring of those areas that are used 
for a covered activity for evidence of animal intrusion immediately prior to harvest and, as needed, during the growing season (proposed § 112.83). 
• Equipment, Tools, and Buildings  
o Establish requirements related to equi pment and tools that contact covered 
produce and instruments and controls (inc luding equipment used in transport), 
buildings, domesticated animals in a nd around fully-enclosed buildings, pest 
control, hand-washing and to ilet facilities, sewage, trash, plumbing, and animal 
excreta (proposed §§ 112.121-134); and 
o Require certain records related to the da te and method of cleaning and sanitizing 
equipment used in growing operations fo r sprouts, and in covered harvesting, 
packing, or holding activ ities (proposed § 112.140). 
• Sprouts 
o Establish measures that must be taken related to seeds or beans for sprouting 
(proposed § 112.141); 
o Establish measures that must be take n for the growing, harvesting, packing, and 
holding of sprouts (proposed § 112.142); 
o Require that you test the grow ing environment for Listeria  spp. or L.  
monocytogenes  and that you test eac h production batch of spent irrigation water 
or sprouts for E. coli  O157:H7 and Salmonella  species and take appropriate 
follow-up actions (proposed §§ 112.143, 112.144, 112.145, 112.146); and 13 
 
o Require certain records, in cluding documentation of your  treatment of seeds or 
beans for sprouting, a writ ten environmental monitoring plan and sampling plan, 
test results, and certain me thods used (proposed § 112.150). 
  As proposed, the effective date  is 60 days after a final rule  is published, however, we are 
providing for a longer timeline for farms to come into compliance.  Small businesses (i.e., those 
subject to proposed part 112 and, on a rolling basi s, the average annual monetary value of food 
sold during the previous three- year period is no more than $500,000) would have three years 
after the effective date to comply; for some of  the water requirements, they would have five 
years.  In addition, very small businesses (i.e ., those subject to proposed part 112 and, on a 
rolling basis, the average annual monetary valu e of food sold during th e previous three-year 
period is no more than $250,000) would have four years after the effective date to comply; for 
some of the water requirements, they would have  six years.  All other farms would have two 
years after the effective date to  comply; for some of the water requirements, they would have 
four years to comply.  
Costs and Benefits 
The baseline estimate for preventing all illnesse s associated with microbial contamination 
of produce covered by this proposed  regulation is $1.6 billion; how ever, we do not expect that 
we will eliminate a ll illnesses associated with covered pr oduce.  Instead, we expect that the 
proposed produce safety regulation will prevent some portion of this illness burden from 
recurring.  We estimate the number of foodborne il lness prevented by this regulation to be 1.75 
million, with an associated benefit of $1.04 billio n, annually.  As described in the Preliminary 14 
 
Regulatory Impact Analysis (PRIA) , making a precise estimate of the rule’s likely effectiveness 
is extremely difficult, because FDA has only limite d data that would esta blish a clear baseline 
estimate of how contamination o ccurs and the likely impact of the proposed provisions on that 
baseline, with respect to causing human illness.  We estimate the costs of the proposed rule to be 
$459.56 million annually for domestic farms, $17 0.62 million annually for foreign farms covered 
by the rule (for a grand total of $630.18 milli on annually), resulting in $406.22 million annually 
in estimated potential net benefits. 
Summary of 
Costs and 
Benefits of the Proposed Rule
1 Prevented 
foodborne 
Illnesses (in millions) Total 
Benefits (in 
millions) Total 
Domestic 
Costs (in 
millions) Total 
Foreign 
Costs (in 
millions) Total Costs 
(Domestic + 
Foreign) Net 
Benefits 
(in millions) 
Total  1.75 $1,036.40 $459.56 $170.62 $630.18  $406.22 
 
  Very Small Small Large 
Average Annual Cost per Farm $4,697 $12,972  $30,566 
 
1 As described in detail in the PRIA, data to estimate the costs and benefits of this rule are limited.  Best estimates 
were made for both the costs and the benefits of the rule, given the data available.  We request comment on these 
estimations, and request, in particular, data related to th e amount of contamination a ttributable to each potential 
pathway of contamination, the relative e ffectiveness of each provision at reducing contamination, and data related to 
current industry food sa fety practices.     
 
 
 15 
 
Proposed Rule 
 
I.  Introduction 
Each year, about 48 million Americans (1 in  6) get sick, 128,000 are hospitalized, and 
3,000 die from foodborne diseases, according to es timates from the Centers for Disease Control 
and Prevention.  The FDA Food Safety Modern ization Act (FSMA) (Pub. L. 111-353), signed 
into law by President Obama on January 4, 2011, en ables FDA to better protect public health by 
helping to ensure the safety a nd security of the food supply.  FS MA enables us to focus more on 
preventing food safety problems rather than primar ily reacting to problems af ter they occur.  The 
law also provides us with new enforcement au thorities to help us achieve higher rates of 
compliance with prevention- and risk-based safety  standards and to better  respond to and contain 
problems when they do occur.  In addition, the la w gives us important new tools to better ensure 
the safety of imported foods and directs us to bu ild an integrated national food safety system in 
partnership with State and local authorities. 
Section 105 of FSMA adds section 419 to the Federal Food, Drug, and Cosmetic Act 
(FD&C Act) (21 U.S.C. 350h) requiring FDA to  publish a notice of proposed rulemaking to 
establish science-based minimum standards for th e safe production and harvesting of those types 
of fruits and vegetables that are raw agricultural commodities for which we have determined such standards are necessary to minimize the risk  of serious adverse health consequences or 
death.  Further, new section 419 also requires FDA to adopt a final regulation based on known 
safety risks, setting forth proce dures, processes, and practices th at we determine to minimize the 
risk of serious adverse health consequences or death, including thos e that are reasonably 
necessary to prevent the introdu ction of known or reasonably fo reseeable hazards into produce 
and to provide reasonable assurances that pr oduce is not adulterated under section 402 of the 16 
 
FD&C Act.  This proposed rule sets forth such st andards, as well as certain exemptions from the 
standards, consistent with sect ion 419 of the FD&C Act.   
Two additional proposed rules, with the produce safety proposed rule, will be the 
foundation of, and central framework for, a new food safety system in the United States.  In an 
accompanying notice in this issue of the Federal Register , FDA is publishing the preventive 
controls proposed rule that  would apply to human food and require domestic and foreign 
facilities that are require d to register under the FD&C Act to have written plans that identify 
hazards, specify the steps that will be put in plac e to minimize or prevent those hazards, monitor 
results, and act to correc t problems that arise.   
FDA also intends to publish the foreign s upplier verification program (FSVP) proposed 
rule, which would help ensure the safety of foods imported into the U.S. by making importers 
accountable for verifying that the food they impor t is produced using processes and procedures 
that achieve the same level of public health pr otection for imported food as required of domestic 
growers and processors under FSMA’ s new standards for produce safety and preventive controls.  
Eating fruits and vegetables is an important part of a healthy diet (Ref. 1).  FDA is 
responsible for ensuring the safety of all domestic  and imported fruits and vegetables consumed 
in the United States.  We place a high priority  on identifying and implementing measures that 
can reduce the incidence of foodborne illness asso ciated 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 significan ce (e.g., bacteria and viruses that can cause 
disease), as well as chemical , physical, and radiological contaminants.  Contamination of 
produce can occur on-farm during growing (either in an open environment or in a fully- or 17 
 
partially-enclosed building), harvesting, packi ng, or holding; or else where along the farm-to-
table continuum.  
 A.  Contamination with Microbiological Hazards 
American consumers enjoy one of the safest supplies of produce in the world.  Over the 
last few decades, however, problems linked to pr oduce, including the associated public health 
implications, have been reported in a number of  countries worldwide.  Many factors affect the 
occurrence of microbial contamin ation of fresh produce, includi ng worker health and hygiene, 
the quality of agricultural water, the use of anim al manure and other materials of animal origin as 
fertilizer, the presence of wild or domestic animal s in or near fields or  packing areas, growing 
and harvesting operations, and equipment and build ing sanitation.  As discussed in more detail 
below, FDA has taken several steps to help redu ce the likelihood of mi crobial contamination; 
significant advances have been made.  However, in spite of these efforts, produce-associated 
foodborne illnesses continue.   
FDA has looked specifically at outbreaks where the point of contamin ation is likely to 
have happened early in the production chai n, during growing, harvesting, manufacturing, 
processing, packing, holding, or transportation 
(Ref. 2).  Of the total repo rted outbreaks and 
outbreak-related illnesse s linked to FDA-regulated foods between 1996 and 2010, in the FDA 
database, produce accounted for 23.3% and 42.3%, respectively. Both domestic produce and imported produce were identified as vehicles  in these outbreaks.  From 1996 to 2010, 
approximately 131 produce-related reported ou tbreaks occurred, resu lting in 14,132 outbreak-
related illnesses, 1,360 ho spitalizations and 27 deaths.  Thes e outbreaks were associated with 
approximately 20 different fresh produce commodities 
(Ref. 3).  Commodities associated with 18 
 
outbreaks during this time period included sprouts;  leafy greens such as lettuce and spinach; 
tomatoes; melons such as cantaloupe and honeyde w; berries such as raspberries, blueberries, 
blackberries, and strawberries; fres h herbs such as basil and parsle y; and green onions as well as 
fresh-cut fruits and vegetables. FDA also ha s evidence that contamination occurs on some 
produce crops at least intermittently based on sa mpling performed as part of investigation, 
inspections, and FDA Domestic and Import Fiel d Assignments and data from United States 
Department of Agriculture (USDA)’s Agricult ural Marketing Service (AMS) Microbiological 
Database program (MDP) (Ref. 4.Ref. 5). For instance, in 2009, AMS tested eight types of 
produce for E. coli O157:H7, non-O 157 E. coli carrying shiga toxin and enterotoxin genes, and 
Salmonella.  MDP identified 51 samples with E.  coli carrying shiga toxin genes; however only 
24 of these were determined to be pathogeni c. MDP identified 32 samples with Salmonella 
confirmed by culture.  The USDA AMS MDP wa s discontinued in 2012 and FDA is evaluating 
options for any future collection of  similar microbiological data.   
The following commodities accounted for 88.5 % of the total produce-associated 
outbreaks: 
• 34 outbreaks associated with sprouts,  
• 30 outbreaks associated with leafy gr eens such as lettuce and spinach 
• 17 outbreaks associated with tomatoes 
• 14 outbreaks associated with melons such as cantaloupe and honeydew  
• 10 outbreaks associated with be rries, such as raspberries, blueberries, blackberries and 
strawberries 
• 6 outbreaks associated with fresh he rbs such as basil and parsley  
• 3 outbreaks associated with green onions 19 
 
 (Ref. 2) 
In the FDA database, fresh-cut fruits and vegetables accounted for 16.8% of the total 
produce-related outbreaks.  Generally, the most li kely point of original contamination for the 
fresh-cut-related outbreaks, as determined by F DA and its federal and st ate partners during the 
outbreak investigations, appears to be during growing, harvest,  packing or holding, while the 
commodity is still in its raw agricultural commodity (RAC) form, rather than during 
manufacturing/processing of the fresh-cut pr oduct (Ref. 2). In a few instances, such as 
unwashed, field packed tomatoes being removed fr om a warm ripening room and placed in cold 
water to firm for slicing (which may ha ve promoted infiltration of pathogens) (Ref. 6), it is 
possible that practices or conditi ons at the fresh-cut facility co ntributed to the contamination 
event.  It is possible that the way product is handled during processing, including mixing large 
batches of fresh-cut product, may spread contam ination across a larger volume of product, 
impacting the size and scope of an  outbreak associated with fresh-c ut produce.  However, there 
have also been a number of very la rge outbreaks associated with RACs. 
Pathogens associated with the produce outbreaks include bacteria, viru ses and parasites.  
Between 1996 and 2010, the majority of fresh pr oduce-related outbreaks and illnesses in the 
FDA database were associated with bacterial agents (86.5%), followed by parasites (11.6%) and 
viruses (1.9%).  These outbreaks involved  a number of pathogens, including E. coli  O157:H7, E. 
coli O157, Salmonella  species (Salmonella  spp.), Listeria monocyt ogenes (L. monocytogenes) , 
Cyclospora , Shigella sonnei , and Hepatitis A.   
In an accompanying document titled “Draft Qual itative Assessment of Risk to Public 
Health from On-Farm Contamination of Produ ce,” FDA has conducted a qualitative assessment 
of risk associated with growing, harvesting, packing, and holding of produce (hereafter referred 20 
 
to as the Qualitative Assessment of Risk (QAR)).  In particular, the QAR is intended to address 
various risk management questions related to bi ological hazards of concern in fresh produce that 
can lead to serious adverse health consequences or death; potential routes of contamination; and 
the likelihood of contamination and likelihood of  illness attributable  to consumption among 
various types of produce commodities. The findings of this qualitative assessment of risk informed our regulatory approach and several proposed provisions. We provide a summary of 
the findings in section IV; additionally, we re fer to the QAR throughout this proposed rule, 
including the discussion of proposed provi sions in section V of this document. 
  B. Contamination with Chemical, Physical or Radiological Hazards 
Chemical contaminants of produce can origin ate from a variety of sources.  Most 
common among these include so il (through previous chemical exposure), equipment (e.g., 
lubricants, fuels, and refrigerants), pesticides , insecticides and rela ted agents, and cleaning 
compounds (e.g., sanitizers) normally used in the course of maintaining buildings and 
equipment.  FDA monitors chemical and pest icide residues in foods through its regulatory 
monitoring programs with emphasis on raw ag ricultural commodities (RACs) and foods 
consumed by infants and children.  Illnesses attributable to chemi cal hazards are rare 
(Ref. 7).  In 
fact, between 1997 and 2011, there have been no Cl ass I recalls of produce associated with a 
chemical hazard for which there is a reasonable pr obability of causing serious health problems or 
death (Ref. 8).  Current monitoring, regulations, and i ndustry practice have been sufficient to 
keep these hazards under control.   Similarly, the potential public health conseque nces of physical hazard contamination (e.g. glass 
or metal fragments) in produ ce appear to be relatively 
(Ref. 7).  Rarely do the physical hazards 21 
 
associated with produce suggest a risk of seri ous adverse health cons equences or death for 
individuals that would consume the product.  In  fact, between 1997 and 2011, there have been no 
Class I recalls of produce associ ated with a physical hazard for which there is a reasonable 
probability of causing serious health problems or death (Ref. 8). 
The presence of radiological hazards in foods  is a rare event and consumer exposure to 
harmful levels of radionuclide hazards, outsi de of catastrophic events, is very low (Ref. 7.Ref. 9).   
While we acknowledge the potential for chemi cal, physical or radiological contamination 
of produce, based on our analysis (Ref. 7), and for the reasons discusse d in section IV.B of this 
document, we are not proposing specific sta ndards for these hazards in this rulemaking. 
 
II. Efforts to Address Produce Safety 
FDA and others have taken a number of actions  to address produce safe ty in the last two 
decades.  This section describes several of  these activities up to and including FSMA. 
 
A. Inspections and Investigations We have conducted a number of inspections a nd investigations that have provided useful 
information about the routes of contamination.  Investigations involved visiting multiple field 
locations and packing operations.  Observations during the investigations revealed several areas 
of farm practices that seem most likely to ha ve been possible routes of contamination for 
produce involved in the outbreaks. Our inspectio ns, investigations, a nd surveillance sampling 
activities are described in more detail in accompanying documents.   
 B. Guidance Documents and Letters to Industry 22 
 
1. GAPs Guide 
On October 2, 1997, President Clinton announced th e ‘‘Initiative to Ensu re the Safety of 
Imported and Domestic Fruits and Vegetables’’ (Produce and Imported Food Safety Initiative or 
PIFSI). As part of this initiative, the President di rected the Secretary of th e Department of Health 
and Human Services (HHS) and the Secretary of the U.S. Departme nt of Agriculture (USDA), in 
cooperation with the ag ricultural community, to issue gui dance on good agricultural practices 
(GAPs) for fresh fruits and vegetables.  In Oc tober, 1998, we issued final guidance to industry 
entitled “Guide to Minimize Microbial Food Safe ty Hazards for Fresh Fruits and Vegetables” 
(GAPs Guide) (Ref. 10) .  This guide contains voluntar y recommendations for good agricultural 
practices (GAPs) that growers and packer s can undertake to address common factors 
contributing to contamination in their operations .  The GAPs Guide is a broad scope guidance 
that takes into account the diversity of conditi ons and practices associated with the growing, 
harvesting, packing and holding of fresh produce.  We noted that  firms should use the general 
recommendations in the GAPs Guide to tailor pract ices to their individu al operations.  As the 
GAPs Guide notes, current technologies cannot eliminate all potential food safety hazards associated with fresh produce that will be eaten raw.  Therefore, the focus of the GAPs Guide is 
on implementing measures to minimize the poten tial for introduction of such hazards.   
On September 2, 2008, we issued a notice in the Federal Register
 (73 FR 51306) 
requesting comments and scientif ic data and information to a ssist us in improving the GAPs 
Guide.  We specifically asked for information about (1) current agricultural practices and 
conditions used to produce, harvest, pack, cool, and transport fresh produce;  (2) risk factors for 
contamination of fresh produce associated with these practices; and (3) possible 
recommendations or additional measures that would enhance the safety of fresh produce.  We 23 
 
also requested information about the estimated cost s and benefits of current  practices and/or the 
cost and benefits of any recommendations. We received approximately two dozen submissions from organizations and individuals, including: industry, government, univers ities, environmental 
groups, consumers, and consumer groups.  A nu mber of comments discussed the value of 
performing operational assessments, developing food safety plans and record keeping but 
suggested that any updated guida nce acknowledge that these activ ities should be commensurate 
with the complexity of an operation and associat ed risks.  Other comments requested additional 
information on microbial testing to ensure that when testing is done it is meaningful and cost 
effective.   
2. Letters to Lettuce, Tomat o, and Cilantro Industries 
 On February 5, 2004, we issued a letter to fi rms that grow, harvest, pack or hold fresh 
lettuce and fresh tomatoes, expressing con cern regarding outbreak s of foodborne illness 
associated with the consumption of these pr oducts, and recommending actions to enhance the 
safety of these products 
(Ref. 11).  On November 4, 2005, we issued a second letter to firms that 
grow, harvest, pack, hold or ma nufacture/process fresh and fresh- cut lettuce, reiterating concerns 
about continuing outbreaks (Ref. 12).  In the November 2005 letter, we strongly encouraged 
applicable firms to review their current operations in light of th e GAPs Guide, as well as other 
available information regarding the reduction or elimination of pathogens on fresh produce.  We 
encouraged firms to consider modifying their ope rations to ensure that they were taking the 
appropriate measures to provide a safe product to the consumer.  We recommended that firms 
from the farm level through the dist ribution level undertake these steps. 
In March, 2011, we issued a lette r to firms that grow, harvest, pack or hold fresh cilantro, 
expressing concern about positive sample findi ngs and recommending actions to enhance the 24 
 
safety of these products(Ref. 13).  Between 2004 and March, 2011, th ere had been 28 confirmed 
Salmonella  positive sample results in fresh cilantro in, or entering into, commerce.  Samples 
were of both U.S. and imported origin.  As with  earlier letters to th e industry, we strongly 
encouraged applicable firms to review their cu rrent operations in light of the GAPs Guide, as 
well as other available informa tion regarding the reduction or e limination of pathogens on fresh 
produce.  We encouraged firms to consider modify ing their operations to ensure that they were 
taking the appropriate measures to provide a safe product to the consumer.  In addition, we 
encouraged these firms to assess hazards unique to the production of cilantro and to develop 
commodity-specific preventive control strategies .  We recommended that firms from the farm 
level through the distribution leve l undertake these steps.    
3. Guidances and Letters Regarding Sprouts  On October 27, 1999, we published a notice of  availability (64 FR 57893) for two 
guidance documents to inform all parties involved  in the production of sprouts (i.e., producers, 
conditioners, and distributors of seeds and bean s used for sprouting, sprout producers) that 
sprouts have been recognized as an important  cause of foodborne i llness and to provide 
recommendations for preventive controls that we  believed should be taken immediately to reduce 
the likelihood of sprouts serving as a vehicle for foodborne illness 
(Ref. 14).(Ref. 15)  The first 
guidance document, “Reducing Microbial Food Safety  Hazards for Sprouted Seeds” (the Sprout 
Guide), provides recommendations based on th e recommendations of the National Advisory 
Committee on Microbiological Cr iteria for Foods (NACMCF) (Ref. 16).  We also released a 
second guidance, “Sampling and Microbial Test ing of Spent Irrigation Water During Sprout 
Production” (the Sprout Te sting Guide), to assist sprouters in  implementing one of the principal 
recommendations in the broader Sprout Guide, i.e ., that producers test sp ent irrigation water for 25 
 
two pathogens (Salmonella  spp. and E coli  O157:H7) before product enters commerce.  We refer 
to these guidances collectively as the Sprout Guides. 
On April 22, 2005, we announced in the Federal Register  (70 FR 20852) a public meeting 
to elicit information on current science rela ted to foodborne illness associated with the 
consumption of sprouts.  The meeting notice co ntained a series of que stions to help focus 
comments, including questions rega rding: (1) Practices that may contribute to contamination of 
seeds used for sprouting and inte rvention strategies that could he lp prevent, reduc e, or control 
contamination of seeds used for sprouting; (2) Whether the preventive c ontrols recommended in 
our Sprout Guides could be improved and, if so, how this might be done; (3) What can or should 
be done to increase the involvement of producers of  seeds for sprouting a nd seed distributors to 
ensure the safety of sprouts; (4) How, if at all, should the actions  to improve the safety of seeds 
for sprouting be structured to take into accoun t variation within the s eed and sprout industry, 
including variations in size of establishments, the types of seeds and sprouts produced and the 
practices used in production; and (5) Existing food safety systems or standards (such as 
international standards) that we should consider  as part of our effort s to minimize foodborne 
illness associated with the consumption of sprouts. 
In general, comments expressed a need to in clude the seed industry, as well as the sprout 
industry, in efforts to improve the safety of sprouts.  Several comments stated that any 
recommendations should be scientifically  sound, based on appropr iate (and feasible) 
expectations for risk reduction, and be easy to understand and implement.  Comments expressed 
concern about the effect on worker health  of treating seed with 20,000 ppm calcium 
hypochlorite.  Comments were generally supportive of  recommendations in the Sprout Guides to 
test spent irrigation water; se veral comments supported expanded te sting, includi ng seed testing 26 
 
by seed producers and distributors .  All but one comment maintained  that seeds were the primary 
source of contamination in spr out-associated outbreaks.  Severa l comments discussed practices 
and conditions, such as animal grazing, whic h could contaminate seed in the field.  One 
comment suggested the industry develop a GAPs gui dance specific to the production of seed for 
use in sprouts.  Several comments supporte d applying Current Good Manufacturing Practices 
(CGMPs) (21 CFR Part 110) to spro ut facilities.  A number of co mments cited the diversity of 
sprout types currently being produced  and noted this diversity of pr oducts is likely to continue to 
grow.  These comments maintained it was ther efore appropriate to provide flexibility for 
individual operations to select mitigations appr opriate for the products th ey produce.   Comments 
to the 2005 Sprout Public Meeting were consid ered in this rulemaking and will be further 
described when we discuss proposed provisions sp ecific to sprouts in section V.M. of this 
document. 
On May 1, 2009, we issued a lette r to suppliers and distributor s of seeds and beans used 
for sprouting, and sprouters, to make firms aw are of our serious concerns with continuing 
outbreaks associated with the consumption of raw and lightly cooked sprouts and to urge firms to 
review their operations in li ght of our Sprout Guides and other available information (Ref. 17), 
and to modify their operations a ccordingly to ensure they are taking appropriate measures to 
provide a safe product to consumers.  We also shared a May 1, 2008, letter from the California 
Department of Public Health (CDPH) to the Cali fornia sprout industry ou tlining several critical 
areas of concern identified in recent investigations and CDPH recommendations for controlling 
hazards associated with those observations (Ref. 18). 
4. Draft Commodity Specific Guidances 27 
 
On August 3, 2009, we published a no tice in the Federal Register  announcing the 
availability for public comment of draft commod ity specific guidances (CSGs) for melons (74 
FR 38437), tomatoes (74 FR 38438) and leafy greens (74 FR 38439).  The draft CSGs are intended for growers, packers, processors, tran sporters, retailers, and others throughout the 
supply chain.  The draft CSGs, if finalized, would provide a framework for identifying and 
implementing appropriate measures to minimize the likelihood of microbi al contamination of 
tomatoes, leafy greens, and melons.  The dr aft CSGs reflect both commodity specific 
information, such as recommendations for tomato repacking, and advances in collective thinking 
in broader areas, such as assess ing potential hazards in and ne ar the field before beginning 
production and immediately before harvest, and protecting and main taining water quality at its 
source and during distribution and use.  The dr aft CSGs are designed to  complement our GAPs 
Guide and Fresh-cut Guide.  On November 4, 2009, we published a notice in the Federal 
Register , extending to January 4, 2010, the comment pe riod on the draft CSGs. We have not yet 
issued these guidances in final form. 
In developing the draft CSGs, we relied h eavily on existing industry commodity specific 
guidelines, our produce safety initiatives a nd programs, lessons learned from outbreak 
investigations, and other public and private programs.  We have  since received several dozen 
written comments, from industry, States, and individuals. Comments we re generally supportive 
of the scope and objectives of the draft CSGs. Comments provided their views on both 
commodity specific issues (e.g., recommendations fo r field packing tomatoes, water quality for 
rehydrating leafy greens after harvest) and cross- cutting issues (e.g., management of wild animal 
intrusion, quality of water used in postharvest operations).  A number of comments requested 
that we recognize different risks may be associ ated with different commodities within the 28 
 
commodity groups covered by the CSGs, noting, for example, that cantaloupe (not watermelon) 
have been identified as the vehicle in the major ity of foodborne illness ou tbreaks associated with 
melons.  A number of comments expressed concer n about potential bias of the CSG approach 
(i.e., separate recommendations for different commodities) against small farms growing a diversity of crops, especially th e concern that the CSG approach  could require such farms to 
have multiple food safety plans to cover each  of the commodities they grow.  Additional 
comments will be discussed when we describe propos ed provisions relevant to those comments.  
5. Guidances Regarding Nuts  On March 11, 2009, we published a notice in the Federal Register
 (74 FR 10598) 
announcing the availability for public comment of  draft guidance for industry: Measures to 
Address the Risk for Contamination by Salmonella  Species in Food Contai ning a Peanut-Derived 
Product as an Ingredient.  Additionally, on J une 29, 2009, we published a notice in the Federal 
Register  (74 FR 310308) announcing the availability fo r public comment of draft guidance for 
industry: Measures to Address the Risk for Contamination by Salmonella  Species in Food 
Containing a Pistachio-Derived Product As An Ingredient.  These draft guidance documents 
were intended for manufacturers who use a pean ut-derived product or pistachio-derived product 
as an ingredient in a food product.  Thes e draft guidances provide recommendations for 
evaluating the effectiveness of certain Salmonella  control measures.  We have not yet issued 
these guidances in final form. 
6. Fresh-cut Guide On March 6, 2006, we published a notice in the Federal Register
 (71 FR 11209) 
announcing the availability on our website of a dr aft Guidance for Industry entitled “Guide to 
Minimize Microbial Food Safety Hazards of Fres h-cut Fruits and Vegetables” (the Fresh-cut 29 
 
Guide).  We received a number of comments from trade associations, consumer groups, and 
industry.  Comments were generally supportive of  the draft Guide.  A few comments included 
questions about our draft defin ition of fresh-cut produce and whet her the recommendations in the 
draft guidance were mandatory or voluntary, in li ght of the mandatory requirements in existing 
CGMPs.   
On February 25, 2008, we published a notice (73 FR 10037) announcing our finalization 
and the availability of our “Guide to Minimi ze Microbial Food Safety Hazards of Fresh-cut 
Fruits and Vegetables” (the Fresh-cut Guide).  The Fresh-cut Guidance complements the CGMPs 
in 21 CFR, Part 110 and provides recommendati ons for a framework for identifying and 
implementing appropriate measures to minimi ze the likelihood of mi crobial contamination 
during the processing of fresh-cut produce.  Examples of recommendations for fresh-cut 
processors in the Fresh-cut Guidance include: (1) know your suppliers and have a mechanism to 
verify that your suppliers use good agricultura l practices, good manufact uring practices, and 
other appropriate food safety pract ices; and (2) ensure equipment is designed to prevent water 
collection.  While fresh-cut produce is not cove red under the scope of th is proposed rule, we 
include a reference to our guidance on fresh-cu t produce as some of the measures recommended 
in that document are relevant to the requireme nts proposed for covered produce in this rule. 
 
B. Produce Safety Action Plan On June 15, 2004, we published a Federal Register
 notice (69 FR 33393) announcing a 
public meeting to elicit information from stak eholders concerning key elements of a draft 
produce safety action plan entitled ``Produce Sa fety From Production to Consumption: An 
Action Plan to Minimize Foodborne  Illness Associated With Fres h Produce'' (the Produce Safety 30 
 
Action Plan or PSAP). We poste d the draft PSAP on June 18, 2004 (Ref. 19). The draft PSAP 
continued the 1997 Produce and Imported Food Safe ty Initiative, buildin g on experience from 
earlier efforts such as the development and im plementation of the GAPs Guide, inspections of 
farms and produce packing facilities, surveillanc e sampling assignments, and investigations of 
foodborne illness outbreaks. The draft PSAP addresse d all principal points between the farm and 
table where contamination of produce could occur. It covered fresh fruit and vegetables in their 
native (RAC) form and raw, minimally processe d products (i.e., fresh-cu t produce) that have 
received some processing to alter their form but have not been subject to a thermal process that 
would eliminate microbial hazards. The draf t PSAP was not intended to cover processed 
products such as juice, or agricultural products other than  fruits and vegetables.   
After considering comments received from various stakeholders, in October 2004, we 
issued the final PSAP.  In recognition that cont amination of produce can happen at any point in 
the supply chain, the PSAP expands on the areas  covered by the GAPs Gu ide (i.e., farms and 
packing houses) to extend to all parts of th e food supply chain from farm through retail or 
consumer preparation and consumption.  The PSAP does not cover frozen fruits and vegetables, 
fruit and vegetable juices, or nuts.  The PSAP has four main obj ectives: (1) prevent 
contamination of fresh produce with pathogens; (2) minimize the public health impact when 
contamination of fresh produce occurs; (3) im prove communication with producers, packers, 
processors, transporters, distribut ors, preparers, consumers, a nd other government entities about 
the safety of fresh produce; and (4) facilitate and support research  relevant to the contamination 
of fresh produce.  For each objective, the PSAP identi fies steps or actions that could contribute to 
the achievement of that objective.  The PSAP ha s measurable goals and outcomes, and several 
steps outlined in the PSAP are already in progres s or have been completed.  For example, we 31 
 
issued the Fresh-cut Guide and provided techni cal assistance to industr y efforts to develop 
commodity specific supply chain guidance as part  of the PSAP objective re garding prevention of 
contamination.   
C. Public Hearings On February, 27, 2007, we published a notice (7 2 FR 8750) of two public hearings, and 
request for comment, on the safety of fresh produce.   In that notice, we stated that we believe 
that the measures outlined in the PSAP, the GAP s Guide, and other public and private sector 
actions, when implemented, can be effectiv e in reducing the likelihood of microbial 
contamination of fresh produce.  However, the f act that outbreaks of foodborne illness associated 
with fresh produce continue to occur supports the need for a close examina tion of: the extent to 
which these measures have been implemented;  whether they have been effective when 
implemented properly; and, what additional or di fferent interventions might be appropriate to 
reduce the likelihood of future outbreaks.   
We held the public hearings to share info rmation about recent outbreaks of foodborne 
illness associated with microbial contamination of fresh produce, and to invite comments, data, and other scientific information about: current practices used to grow, harvest, pack, hold, 
manufacture/process, and transpor t fresh produce; risk factors fo r contamination of fresh produce 
associated with these practices; and measures F DA could take to enhance the safety of fresh 
produce.  The notice of hearings included a list of issues and que stions to help focus comments 
and asked for scientific information and data.  We received approximately 48 submissions from 
industry, government, universities, environmen tal groups, consumers, and consumer groups.  
Recurring comments included: the importance of ac tivities to promote or enhance rapid, accurate 32 
 
traceback; strengthened coordina tion and communication between a ll sectors (i.e., researchers, 
regulators, and industry) on avai lable science and current unpublis hed data; and an integrated, 
multidisciplinary approach to identify best practices not currently incorporated by industry.  A number of comments expressed concerns about the cost of third part y audits and lack of 
standardization of such audits.  Comments also indicated a desire for training.  Comments were 
divided on whether we should c ontinue to promote adoption of voluntary GAPs guidance or 
pursue rulemaking to establish mandatory requirements.  Comments supporting mandatory requirements differed on what these requirement s should look like; suggestions ranged from 
mandatory GAPs to a Hazard Analysis and Criti cal Control Point (HACCP)-like approach, or a 
combination of the two.  Comments were in general agreement that, whatever regulatory 
approach was chosen, it should be consistent across the United States, based on sound science, 
and cover a broad range of commodities while be ing flexible enough to accommodate the needs 
of specific commodities, regions, operations, practices, and different sizes of operations.   
 
D. Partnerships and Collaborations 1. Public and Private Standards Because the GAPs Guide is voluntary, FDA a nd food safety partners in the public and 
private sectors have emphasized education and outreach to indus try to promote adoption of the 
guidance.  Buyer requirements that producers an d other suppliers provid e self- or third party 
audit verification that they are following the GAP s Guide have further promoted adoption of the 
guidance.  We have worked with the fresh prod uce industry since the re lease of the GAPs Guide 
to promote its recommendations and to advance th e scientific knowledge a pplicable to enhancing 
the safety of fresh produce.  For example, in  conjunction with the PSAP, we have provided 33 
 
technical assistance to indus try in developing several industry commodity specific 
guidelines that cover the entire supply ch ain, including commodity-specific guidelines for 
melons, leafy greens, tomatoes, and green onion s; these commodities together accounted for 70 
percent of the foodborne out breaks associated with produce between 1998 and 2009 (Ref. 3).  
These industry guidelines were in turn helpfu l to us in developing FDA’s draft commodity 
specific guidances for the same commodities (see section II.B.4 of this document).  Additional industry guidelines have been developed or ar e in progress for a broad range of commodities, 
including: strawberries, mushrooms, watermel on, potatoes, storage onions, and citrus.   
We provided technical assistan ce to the Association of F ood and Drug Officials (AFDO) 
to formulate a Model Code of Practice for the Pr oduction of Fresh Fruits and Vegetables (the 
Model Code) 
(Ref. 20).  This work grew out of a request fr om the tomato industry in late 2006 to 
address outbreaks of foodborne i llness attributed to fresh tomatoes.  However, the AFDO Board 
believed that it was also important  to address GAPs in the producti on of a broader range of fresh 
fruits and vegetables.  Thus, AFDO convened a working group to develop a Model Code for 
produce safety during growing, ha rvesting, packing and holding that could be considered as a 
model for guidance and/or regulation by Fede ral and State regulatory bodies, and for 
collaboration among such parties and the industry. The Model Code does not address the additional processing steps that may occur at a fre sh-cut or other proce ssing facility, which is 
covered by the CGMPs in 21 CFR part 110.  The Model Code focuses on minimizing the 
potential for contamination of  fresh produce with pathogens. 
Through cooperative agreement with Cornell University, FDA has, together with USDA 
AMS, established a jointly funded Produce Safe ty Alliance (PSA), based on the successful 
Seafood HACCP Alliance for Training and Educa tion. The PSA is a public-private partnership 34 
 
that will develop and disseminate science- and ri sk-based training and education programs to  
provide produce farms with fundamental food sa fety knowledge, starting in advance of this 
proposed rule and continuing af ter the final rule is promulgated.  The PSA includes active 
participation from the produce industry and academic institutions nationwide.  The curriculum development process has already started, thr ough establishment of t opic-specific working 
committees charged with identifying challe nges to understanding and implementing GAPs on 
farms. This first phase of work, in advance of a fi nal rule, is intended to assist farms, especially 
small farms, in establishing appropriate food sa fety measures, consistent with the GAPs Guide 
and other existing guidances, so that they will be better positioned when we issue a final rule 
establishing produce safety standa rds under section 419 of the FD&C  Act.  As this rulemaking 
progresses, the PSA materials will be modified, as needed, to be consistent with the requirements 
in the rule.   
2. Foodborne Illness Investigations - Environmental Assessment Model 
An “environmental assessment,” in the foodborne  illness outbreak or food contamination 
setting, means an investigation that is triggered by an outbr eak of foodborne illness or food 
contamination incident with the purpose of  determining how the environment may have 
contributed to the introduction or transmission of  pathogens or other hazards that caused illness 
or contamination.  In addition to our more trad itional investigational team approach, during this 
process we work collaboratively with a number of experts from CDC, St ate and local agencies, 
and industry.   
In 2010, we conducted an environmental assessm ent in response to a foodborne illness 
outbreak involving 33 cases of STEC O145 infecti on in 5 States.  While we have not made a 
definitive determination regarding how or at  what point in the supply chain E. coli
 O145 35 
 
contamination occurred, this assessment was impor tant in a number of re spects.  As mentioned 
above, we worked collaboratively with a number of experts from CDC, St ate and local agencies, 
and industry.  Working with this team, we assessed potential sources of E. coli  O145 not just in 
the field of interest, but in th e larger growing area surrounding the field of interest, along with 
the potential for E. coli  O145 to be transported from a sour ce in the surrounding area to the field 
where implicated lettuce was grown.  This highl y collaborative, systems-based approach allowed 
for the discovery of important environmental risk factors that would not t ypically be explored by 
conventional investigation methods (Ref. 21).  On December 29, 2010, we posted a report, 
entitled “Environmental Assessment: N on-O157 Shiga Toxin-Producing E. coli  (STEC): 
Findings and Potential Preventive Control Strategies” (Ref. 21), outlining the environmental 
assessment approach used in th is investigation, our observations  and tentative conclusions.   
In 2011, we conducted an environmental assessm ent in response to a foodborne illness 
outbreak involving a total of 139 pe rsons infected with any of four  outbreak-associated strains of 
L. monocytogenes , including 29 deaths, in 28 States (as of November 1, 2011).  On October 19, 
2011, we posted a report, entitled “Environmental Assessment: Factors Potentially Contributing 
to the Contamination of Fresh Whole Cantaloup e Implicated in a Multi-State Outbreak of 
Listeriosis,” providing an overvie w of the assessment process, pot ential contributing factors in 
this outbreak, and recommended m easures firms should employ to prevent similar contamination 
(http://www.fda.gov/Food/FoodSaf ety/FoodborneIllness/ucm276247.htm ).  As discussed further 
in sections III.F and V.A.2.b.i of this document, this proposed rule would not apply to off-farm 
packing facilities such as the p acking facility associated with this cantaloupe outbreak-- such 
facilities would instead be subj ect to existing part 110 and se ction 418 of the FD&C Act.  36 
 
However, we include the findings of this environmental assessment here because the 
contributing factors are relevant to both on-fa rm and off-farm produce packing practices.   
3. Produce Safety Initiative Assessments  In August 2006 we launched the Leafy Greens Safety Initiative (LGSI), a multi-year 
initiative which involved assessm ents of practices and conditions at select leafy greens farms and 
facilities in California 
(Ref. 22).  In the summer of 2007, we began a multi-year Tomato Safety 
Initiative (TSI) to assess pract ices and conditions asso ciated with growing and packing tomatoes 
on the Eastern Shore of Virginia, followed by as sessments in three tomato growing areas in 
Florida (Ref. 23). 
The initiatives were conducted as part of a strategy to reduce foodborne illness by 
focusing food safety efforts on specific products, practices, and growing areas that have been 
identified in past outbreak inve stigations. The initiatives were a collaborative effort between 
FDA and the State health and agriculture departme nts in California, Virginia, and Florida, in 
cooperation with several universit ies and members of the produce industry.  Both initiatives 
contained several important components, the most visible of which was a series of assignments 
to the field to assess conditions and practices at farms and pack ing houses that could lead to 
contamination and to observe actions taken by growers and packers in response to these 
conditions.  Other important components of th e initiatives included continuing communication 
and outreach with the industry at  all points along the supply ch ain, facilitating and promoting 
research to enhance leafy green  and tomato safety, and streng thening collaboration between 
Federal, State, and local public health offi cials in disease detection and response.  
Assessments of tomato packing facilities covered dump tank water quality parameters, 
employee hygiene, and facility cleaning and sa nitation practices. Asse ssments of the farms 37 
 
addressed irrigation water sources (such as pond s and wells), source wate r and procedures for 
mixing crop chemicals, the potential impacts of  weather events, such  as drought and flooding, 
and animal proximity to growing fields.  Assess ments were scheduled to coincide with tomato 
production and harvest seasons on the Eastern Shor e of Virginia and in three tomato producing 
regions in Florida.  
Where the teams observed conditions or practices  at one or more locations that might be 
improved, they shared those obser vations directly with the indi vidual firm and also shared 
observations in general terms at a post-assessment meeting so that all interested parties could 
apply the findings to their operations.  For example,  we identified issues related to proximity of 
portable toilets to irriga ting ponds and harvesting of drops at one or more locations.  The teams 
recommended that portable toile ts should be distanced from th e irrigation pond and policies that 
forbid the harvesting of drops should be strictly enforced.   We also shared preliminary 
observations through other venues, including a tomato research pr iorities meeting in College 
Park (hosted by Joint Institute for Food Safety and Applied Nutrition (JIFSAN) and the 
University of Florida’s Institute of Food and Agricultural Sciences) (JIFSAN 2010 (update)), a 
Leafy Greens Research Needs workshop hosted by United Fresh in Herndon, VA (United Fresh 
2008), and as technical assistance to public and private efforts to develop new or enhanced 
guidances.   
4. Research FDA researchers have focused on refining or developing methods to detect, isolate and 
subtype pathogens of concern in produce, to enha nce our ability to analyze samples in support of 
our compliance activities. As resources permit, FDA scientists also directly investigate questions 
about factors contributing to produce contaminati on.  We also supported extramural research and 38 
 
collaborations with other Federal agencies, academic institutions, and industry-supported entities 
to leverage research efforts, expertise, and re sources (such as experime ntal stations for field 
research).  This includes successful collaboration s with USDA on research of mutual interest.  
To fill knowledge gaps, thus fac ilitating implementation of any new policies, we have initiated 
new agreements with USDA to conduct research in  key areas such as agricultural water and soil 
amendments (Ref. 24).  Specifically, FDA has provided approximately one million dollars to 
sponsor research at USDA ARS and to develop a produce safety rule re search network at the 
Western Center for Food Safety at University of  California Davis.  We intend these collaborative 
efforts to result in the collection of data that ma y help resolve questions about the necessary time 
between application of raw manure or contaminated water an d safe harvest of produce in key 
agro-ecological growing conditions and for key crops.  Our goal is for this research to result in 
suggested protocols that farms c ould follow in compliance with a final produce rule, and for this 
process to be duplicated for other crops and re gions as further funding is secured.  This FDA 
sponsored research was initiated to demonstrate the commitment of federal agencies to address 
the needs of farmers, to provide initial data to finali ze study protocols for further research, and to 
attract matching funds from industry. 
In partnership with academic institutions acr oss the country, FDA has also created four 
Centers of Excellence (CoE), each housed at a un iversity and charged with specific food-safety 
tasks (Ref. 25).  In 2008, a 5-year cooperative agreemen t was awarded to the University of 
California, Davis (UC Davis) to establish the most recent of th ese CoEs, the Western Center for 
Food Safety (WCFS). Through this agreement, FDA has been able to leverage the resources and 
expertise of UC Davis to study the impact of the unique geography and ecology of the growing 
regions of the Western United States. 39 
 
5. Engagement with other Federal Agencies 
FDA regularly consults and coordinates with  other Federal agencies in the area of 
produce safety.  Examples of these efforts can  be found throughout this document and include 
collecting samples, sharing data, providing trai ning and technical assist ance to industry, and 
research.  Our partnerships with USDA and CDC have  been particularly valu able to our efforts.  
6. Engagement with Industry and Academia We regularly engage with experts in the produce industry and in academia. These 
engagements serve to both educate the industry about our thinking, activi ties, and expectations, 
and to educate us about current industry practices  and academic efforts to enhance the safety of 
produce. 
In addition to the collaborations mentioned above, we initiated multiple produce industry 
listening sessions across the country prior to th e passage of FSMA.  At these sessions, we 
provided local industry and academia an opportunity  to ask questions and voice concerns about 
the potential for legislation impacting the produce i ndustry.  We visited a total of 13 States with 
significant produce production in  2010. FDA and USDA technical  experts, scientists and 
managers participated in these meetings, and we we re able to tour large and smaller scale farms, 
and talk to people with practical experience  in production and implementing food safety 
programs on farms. 
We also were involved with the Produce Sa fety Project (PSP), a research and advocacy 
organization based at Georgetown University an d funded by the Pew Charitable Trust.  The PSP 
provided four issue briefs 
(Ref. 26.Ref. 27.Ref. 28.Ref. 29) each focused on specific aspects of 
produce production, the risks they may represent, prevention and mitigation strategies to address 
these risks, and further research needs in the area. Further, PSP held 6 regional stakeholder 40 
 
discussion sessions to elicit co mment and reaction from the produ ce industry, and to offer an 
avenue to speak directly to the documents’ au thors. A common message from the industry during 
these discussions was concern abou t food safety and a desire to know  how to reduce risks.  Small 
growers and packers in particular conveyed a ne ed for information and technical support that 
would assist them in implementing food safety practices. 
 E. Current Industry Practices 
In response to foodborne illnesses associated  with produce in the mid 1990s, the produce 
industry developed produce safety guidance, engaged in outreach regarding produce safety best practices, developed compliance auditing progr ams, and funded produce safety research.  
 1.  Industry Produce Safety Best Practices Guidance 
In 1997, the International Fresh-cut Produ ce Association and the Western Growers 
Association published Voluntary Food Safety Gu idelines for Fresh Produce, which provided 
generalized voluntary industry gui delines to minimize the potential for contamination for fresh 
produce in growing, packing, shipping and proce ssing operations.  After FDA issued our GAPs 
Guide, industry developed commodity specific gu idances for various produce industry segments 
including: Commodity Specific Food Safety Gu idelines for the Melon Supply Chain (2005),  
Commodity Specific Food Safety Guidelines for the Lettuce and Leafy Greens Supply Chain 
(2006),  Commodity Specific  Food Safety Guide lines for the Fresh Tomato Supply Chain (2006 
1
st Edition, 2008 2nd edition) and Commodity Specific Food Safety Guidelines for the 
Production, Harvest, Post-Harvest, and Valued-Adde d Unit Operations of Green Onions (2010).  
In addition, other industry segments including, bu t not limited to mushrooms, strawberries, 
watermelons, citrus, avocados, almonds, and dry bulb onions develope d commodity specific 41 
 
guidances.  The fresh-cut produ ce industry, via the In ternational Fresh Produce Association, 
published in 1992 Food Safety Guidelines for the Fresh-cut Produce Indust ry and updated this 
publication periodically, with the 4th edition being published most recently in 2001.   
 2.  Produce Industry Food Safety Compliance Auditing 
Shortly after the FDA GAPs Guide was fina lized, a number of retail produce buyers 
informed suppliers that as a c ondition of sale, their produce suppliers must follow, and be third 
party audited for conformance with, the FDA GAPs guide (Ref. 30).  In 1999 USDA AMS began 
developing a GAPs and Good Handling Practices (GAP & GHP) Audit Verification Program, in 
response to requests from growers and the Asso ciation of Fruit and Vegetable Inspection and 
Standardization Agencies.  The program, based on the GAPs Guide, was piloted in 2000 and 
fully available later that same year.  In Se ptember 2001 the United Fresh Fruit and Vegetable 
Association published guidance entitled Food Safe ty Auditing Guidelines: Core Elements of 
Good Agricultural Practices for Fresh Fruits and Ve getables to provide the basis for GAPs audits 
in the produce industry. In 2011 the United Fres h Produce Association published a Harmonized 
GAPs Standard for use by producers and third part y auditors in the fresh produce industry.   
In 2007 leafy greens growers in California, with the assistance of the USDA AMS and 
CDFA, developed and implemented the Califor nia Leafy Greens Marketing Agreement (CA 
LGMA) (Ref. 31).  The objective of the CA LGMA is to protect public health via compliance 
with the food safety practices accepted by the LGMA board, verified through mandatory 
government audits of members and signatories to  the agreement by CDFA auditors trained and 
licensed by USDA AMS (Ref. 31).  In 2007 leafy greens growers in Arizona also adopted a 
similar marketing agreement and audit structure for their growers (Ref. 32).  At the request of 
industry, the USDA AMS in 2009 held seven heari ngs throughout the Unit ed States to solicit 42 
 
input from the leafy greens industries across the US regarding their desire to develop a proposed 
national marketing agreement for leafy green s (74 FR 45565).  A deci sion regarding the 
proposed USDA AMS national marketing agreemen t for leafy greens is currently pending.   
In 2007, the Florida Legislature passed a law th at provided the Depart ment of Agriculture 
and Consumer Services with the au thority to address safety concer ns related to fresh tomatoes.  
Implementing regulations which became effec tive on July 1, 2008 (Florida Tomato Inspection 
Regulation 5G-6, 2007) adopted and incorpor ated by reference almost all of the 
recommendations in the Commodity Specific Food Safety Guidelines for the Fresh Tomato Supply Chain, 2nd Edition (July 2008).   GAPs implementation and GAPs audits ha ve now become common components of 
purchase specifications for produce in some market  segments, and have been a significant force 
in increasing awareness of GAPs and promoting their implementation 
(Ref. 33).  However, 
growers and packers who sell product through dir ect marketing channels, or to buyers who do 
not include GAPs as a condition of sale, may be less familiar with GAPs. 
3.  Produce Industry Produce Safety Education Outreach 
In addition to participation in the PSA housed  at Cornell University (discussed above in 
section II.D. of this document), the produce indu stry promoted adoption and implementation of 
the recommendations in the FDA GAPs Guide through education and outreach efforts in 
cooperation with the land grant universities.  The Na tional GAPs Program at Cornell University, 
with collaborators at other land grant universitie s, developed a series of  publications to train 
domestic growers and packers on the key principles of  produce safety, including: Food Safety 
Begins on the Farm: A Grower’s Guide (2000); F ood Safety Begins on the Farm: A Grower Self 
Assessment of Food Safety Risks (2003); and, Fru its, Vegetables, and Food Safety: Health and 43 
 
Hygiene on the Farm (2004).  These publications a nd others developed by land grant universities 
throughout the United States have been used to train the produce industry on produce safety best 
practices. 
 F. 2010 Federal Register Notice and Preliminary Stakeholder Comments 
On February 23, 2010, we published in the Federal Register
 (75 FR 8086; 2010 FR 
notice) a notice opening a docket to obtain information about  current practices and conditions for 
the production and packing of fresh produce. On  May 20, 2010, we extended the original 90-day 
comment period for the docket until July 23, 2010 ( 75 FR 28263).  We established this docket to 
provide an opportunity for interested parties to  provide information and share views that would 
inform the development of (1) safety standards for fresh produce at the farm and packing house 
and (2) strategies and cooperative efforts to ensure compliance.   
In particular, we welcomed input on thes e general categories: (1) Role of the good 
agricultural practice recommendations in the GAPs Guide; (2) Standards for domestic and 
foreign growers and packers; (3 ) Identification and prioritiza tion of risk factors; (4)  
Environmental assessment of hazards and possible pa thways of contamination; (5) The impact of 
scale/size of growing operations on the nature and degree of possible food safety hazards; (6)  
Methods to tailor preventive controls to particul ar hazards and conditions affecting an operation; 
(7) Possible approaches to tailori ng preventive controls to the scale of an operation so that the 
controls achieve an appropriate level of food safety protection a nd are feasible for a wide range 
of large and small operations; (8 ) Coordination of produce food safe ty practices and sustainable 
and/or organic production methods; (9) Coordi nation of produce food sa fety practices and 
environmental and/or conservation goals or prac tices; (10) Coordination of produce food safety 44 
 
practices and Federal, state, lo cal and tribal government statutes  and regulations; (11) Microbial 
testing; (12) Postharvest operati ons and the role of the CGMPs in  21 CFR part 110; (13) Records 
and other documentation that would be useful to industry and regulators in ensuring the safety of 
fresh produce; and (14) Strategi es to enhance compliance.  
We further advised that information previously submitted to the dockets requesting 
comments on the draft commodity-specific guida nces (CSGs), or to the docket requesting 
comments and scientific data and information to update the GAPs Guide, would be considered in 
this rulemaking and need not be resubmitted.  Comments submitted to these dockets, i.e., dockets 
on the GAPs Guide update and draft CSGs, as well as comments at the Sp routs Public Meeting 
and Produce Safety Hearings, are discussed in sections II.B. and II.D. of this document. 
In response to the 2010 FR notice, we rece ived about 880 comments from consumers, 
farmers and producers, industry gr oups and trade associations, consumer groups, environmental 
groups, academia, retail establishments, pack ers and handlers, food markets and coops, 
laboratories and public health facilities, and fede ral, state, local and foreign governments.  The 
USDA Agricultural Marketing Serv ice (AMS) submitted a re cord of their public hearings related 
to their proposed voluntary national marketing agreement for leafy green vegetables (NLGMA) 
(74 FR 45565, September 3, 2009 and 74 FR 48423, Se ptember 23, 2009), and requested that we 
consider the contents of that record (which included testimo ny, exhibits, and written arguments 
or briefs based on evidence received at the public hearing) in our delibera tions to develop safety 
standards for fresh produce.  A summary of general comments received is presented in this 
section while specific comments re levant to the issues addresse d in this proposed rule are 
discussed in sections V.C through V.R of this document.   
1.  Comments on Impact, Flex ibility and Transparency 45 
 
Overall, a majority of stakeholders, in cluding farmers, producers, consumers and 
industry, expressed concern about th e scope and impact of regulati on on the livelihoods of those 
who produce food and on their ability to produce food in an economically-feasible manner.  
Most comments supported a food safety system , grounded in science, for the production of 
produce in a fair and equitable manner for bot h domestic and imports.  Comments noted that 
regulations developed should be science-based and provide for producers to manage risks in a 
manner appropriate to  their operations. Several comments maintained that risk assessments, 
hazard assessments, operational assessments and de velopment of food safety plans are vital tools 
for farmers to be able to demons trate that the food safety practic es they employ are effective.  
Conversely, others questioned the need for some  industry segments, such as small farms or 
growers of “low risk” commodities to establish food safety plans.  A majority of comments also stated that research is needed on various issu es relevant to produce safety, including water 
quality, soil amendments, animals (both wildli fe and domesticated), and worker health and 
hygiene.  Comments urged the agency to ta ilor regulations to reflect va riables such as farm size, 
markets served, growing conditions, and risk.  In addition, comments highlighted the  importance 
of transparency in the development and implemen tation of food safety standards, and expressed 
that transparency provides regulat ors, buyers, and the public with the confidence they need to 
ensure that all reasonable and re quired practices have been put in  place and that any specific 
producer or packer of produce is in complia nce with required food safety practices. 
FSMA directs us to establish science-based mi nimum standards for produce safety.  These 
standards are to include procedur es, processes, and practices that  we determine to be reasonably 
necessary to prevent the introdu ction of known or reasonably fo reseeable biological, chemical, 
and physical hazards into covered produce and to  provide reasonable assurances that produce is 46 
 
not adulterated under section 402 of the FD&C Act.   As discussed in section IV below, FDA 
intends to adopt a regulatory approach that co nsiders the risk posed by both the commodity and 
relevant agronomic practices, a nd provides the most appropriate balance between public health 
protection and flexibility.  We r ecognize the need to incorporate appropriate flexibility within 
regulations to reflect the diversity of commod ities and associated processes, practices, and 
conditions covered within the scope of this rule .  For example, exemptions based on monetary 
value of food sold by the farm and direct  farm marketing, commercial processing of 
commodities, and other criteria are reflected in proposed subpart A.  Under certain specified 
conditions, qualified exemptions and associated modified requirements in a calendar year are 
also provided under proposed subpart A.  In addition, proposed § 112.12 would establish a 
framework for alternatives to certain requirements of the rule .  We realize that numerous 
differences exist among practices based on risk or agro-ecological c onditions and therefore 
alternatives to certain requirements would be permitted when adequate and documented 
scientific data or information support such alternatives.  Si milarly, proposed subpart P sets 
procedures for a State or forei gn country to request a variance fr om one or more requirements of 
this part when certain conditions  are met, as required by Secti on 419(c)(2) of the FD&C Act.  
For example, a State or foreign country may cons ider that the historic al performance of an 
industry within their jurisdiction (e.g., as i ndicated by the epidemiological record) and the 
combination of measures taken by that industry merits requesting a variance from some or all 
provisions of this proposed rule.  In requesti ng a variance, among other things, the State or 
foreign country would submit info rmation that, while the procedur es, processes and practices to 
be followed under the variance would be different from those prescribed in this proposed rule, 
the requested variance is reasona bly likely to ensure that th e produce is not adulterated under 47 
 
section 402 of the FD&C Act and provide the sa me level of public health protection as the 
requirements of the final regulations (see proposed 112.173).  FDA would encourage 
consideration of these kinds of submissions. 
Furthermore, in addition to soliciting comment s on the proposed regulatio n through this notice, 
we will be holding public meetings in diverse ge ographic areas of the Un ited States to provide 
persons in different regions an opportunity to comment, as required under Section 419(a)(2) of 
the FD&C Act. 2. Comments on Environmental Considerations 
Several comments pointed out that there ar e a number of state and federal laws and 
programs that relate to environmental stewards hip, and noted that environmental conservation 
and food safety are not necessarily cross-co mpeting goals.  Comments favored a uniform 
regulatory approach among Federal, State, local and tribal governme nts’ statutes and regulations, 
and recommended that we consider the work  of other Federal agencies, including the 
Environmental Protection Agency, the Department  of Agriculture, and the Department of the 
Interior in developing proposed requirements for produce to ensure such requirements do not 
unnecessarily inhibit co-management of food safety and environmental concerns.  In this regard, 
a few comments stated that while  co-management of food safety  and sustainability may be 
considered, ultimately, food safety has to be top priority and it is unaccep table to sell unsafe food 
to customers. Section 419(a)(3)(D) of the FD&C Act directs that  this proposed rule take into consideration, 
consistent with ensuring enforceable public heal th protection, conservation and environmental 
practice standards and policies established by Federal natural resource conservation, wildlife 
conservation, and environmental agencies.  As discussed further in Sections III.A.8 and V.I, we 48 
 
consulted with several Federal agencies in orde r to take into consid eration conservation and 
environmental practice standards and policies establishe d by those agencies.  FDA also plans to 
work closely with Federal, State, and local agencies in implementing the final rule.   
3.  Comments on Guidance and Education A majority of comments also expressed t he need for guidance to assist stakeholders in 
implementing the requirements esta blished in final regulations.  Moreover, several comments 
stressed the importance of educational program s and incentives in any effective food safety 
system.   
Section 419(e) of the FD&C Act requires F DA to publish updated good agricultural practices 
and guidance for the safe production and harves ting of specific types of fresh produce, in 
consultation with the Secretary of Agriculture , representatives of State departments of 
agriculture, farmer representativ es, and various types of entitie s engaged in the production and 
harvesting or importing of fruits and vegetables that are raw agricultural commodities, including 
small businesses. In addition, section 419(e)  of the FD&C Act requires FDA to conduct 
education and outreach regarding this guidance through public meetings in diverse geographical 
regions.  FDA intends to provide ample opportun ity for public consultation and input and will 
strive to develop stronger partnerships with the priv ate sector to ensure optimal use of resources.  
4.  Comments Related to Foreign Producers  
A number of foreign governments expressed co ncerns with the foreign producers’ ability 
to comply with and FDA’s enforcement of the regulation, stressing the n eed for transparency.  
Some comments requested we cons ider convergence with existing pr ivate schemes, such as the 
Global Food Safety Initiative and Global G.A.P to avoid duplication of efforts while others urged 
us to consider recognition of foreign governments’ produce safety initiatives. 49 
 
 In implementing a final rule based on this  proposed rule, we intend to provide equal 
treatment in the application, compliance, and en forcement of the proposed standards for foreign 
and domestic facilities.  Recognizi ng that foreign farms in some countries may have difficulty in 
understanding the rule’s applicability to them, we will partner with stakeholders to identify areas 
for outreach and technical cooperation to ach ieve greater understanding of the proposed 
provisions.     
Furthermore, consistent with section 419(c)(2) of the FD&C Act, in proposed subpart P, 
we establish a procedure whereby a State or foreign country could request a variance from one or 
more requirements proposed in the rule, where the State or foreign country determines that (1) 
the variance is necessary in light  of local growing conditions; and (2) the procedures, processes, 
and practices to be followed under the variance are reasonably likely to ensu re that the produce is 
not adulterated under section 402 of the FD&C Ac t, and to provide the same level of public 
health protection as the requirements of this  rule (see section V.P. of this document). 
 
G. White House Food Safety Working Group In 2009, President Obama established a White House Food Safety Working Group to 
identify measures needed to upgrade our food safety laws for the 21st Century, coordinate 
Federal efforts, and develop s hort- and long-term agendas to make food safer.  Specific 
objectives of this workgroup included:  fosteri ng coordination of food safety efforts throughout 
the government and ensuring laws are being adequa tely enforced to keep the American people 
safe from foodborne illness.  The workgroup was co-chaired by the Secret aries of the HHS and 
USDA.  Participating agencies included FDA,  USDA’s Food Safety and Inspection Service 50 
 
(FSIS), CDC, the Department of Homeland S ecurity, the Department of Commerce, the 
Department of State, EPA, and several offices of the White House.    
On July 7, 2009, the workgroup released its report “Implementing a National Public 
Health Approach to Food Safety: Report to  the President.”  This report included 
recommendations for a new public health-focused approach to the safety of all food based on 
three core principles: (1) Prioritizing preventi on, (2) strengthening surveillance and enforcement, 
and (3) improving response and recovery.  Workgroup recommendations and White House 
directives specific to produce included (1) issuing commodity-sp ecific guidances to reduce the 
likelihood of microbial contamina tion in the production and dist ribution of tomatoes, melons, 
and leafy greens; and (2) taking steps (including seeking public co mment) to establish required 
practices through regulation.  The numerous steps we  have taken in response to these directives 
are described throughout this section. 
 
H. Other Related Issues 
1. Tracking and Tracing of Produce Our regulations in 21 CFR part 1, subpart J require that persons who manufacture, 
process, pack, transport, distri bute, receive, hold, or  import food in the United States establish 
and maintain records identifying the immediate previous sources and immediate subsequent 
recipients of food.  During an outbreak of foodborn e illness, these records can help determine the 
source of the food implicated in the outbreak.  Farms are excluded from the requirements of part 
1, subpart J.  We recently held public meeti ngs to stimulate and focus a discussion about 
mechanisms to enhance product tracing systems for food in general (74 FR 56843; November 3, 
2009) and for produce in particular (73 FR 55115; September 24, 2008).  Section 204 of FSMA 51 
 
now directs us to take a variety of different actions that will enha nce our ability to track and trace 
foods, including to establish pilot projects to explore and evaluate methods to rapidly and 
effectively identify recipients of food to preven t or control a foodborne illness outbreak.  Further 
efforts to enhance the tracking a nd tracing of food are outside of th e scope of this proposed rule. 
2. Transportation of Food On April 30, 2010 (75 FR 22713), we published in the Federal Register
 an Advance 
Notice of Proposed Rulemaking (ANPRM) as a fi rst step in implementing the Sanitary Food 
Transportation Act of 2005 (SFTA).  SFTA requires the Secretary of HHS to issue regulations 
setting forth sanitary transpor tation practices to be followe d by shippers, carriers by motor 
vehicle or rail vehicle, receive rs, and others engaged in food transport.  Section 111 of FSMA 
directs us to promulgate regulati ons to implement SFTA.  We inte nd to focus our efforts directed 
to sanitary transportation pr actices as a separate rulema king, already underway under the 
ANPRM.  However, such efforts are outside  of the scope of this proposed rule. 
  52 
 
 
III.  Legal Authority 
FDA is proposing this regulation under th e FD&C Act as amended by FSMA, and the 
Public Health Service Act (PHS Act).   
 A.  Section 105 of FSMA and Section 419 of the FD&C Act On January 4, 2011, the FDA Food Safety Mode rnization Act (FSMA) (Public Law 111-
353) was signed into law.  Section 105 of FSMA, Standards for Produce Safety, among other 
things, amends the FD&C Act to create a new section 419 with the same name.   
Section 419(a)(1)(A) of the FD&C Act dir ects the Secretary of HHS, “in coordination 
with the Secretary of Agriculture and represen tatives of State depart ments of agriculture 
(including with regard to the national organi c program established under the Organic Foods 
Production Act of 1990), and in consultation with  the Secretary of Homeland Security,” to 
“publish a notice of proposed rulemaking to esta blish science-based minimum standards for the 
safe production and harvesting of those types of fruits and vegetables, including specific mixes 
or categories of fruits and vegetables, that are raw agricultural commodities for which the Secretary has determined that such standards minimize the risk of serious adverse health 
consequences or death.”  In addition to this broad direction in sect ion 419(a)(1)(A), section 
419(a)(3) establishes more specific requirements for the content of the proposed rule, including 
that the proposed rule: 
• “[P]rovide sufficient flexibility to be applicab le to various types of entities engaged in the 
production and harvesting of fruits and vegeta bles that are raw agricultural commodities, 
including small businesses and entities that se ll directly to consumers, and be appropriate 53 
 
to the scale and diversity of the production and harvesting of such commodities” (section 
419(a)(3)(A)); 
• “[I]nclude, with respect to growing, harvesting, sorting, p acking, and storage operations, 
science-based minimum standards related to soil amendments, hygiene, packaging, 
temperature controls, animals in the growi ng area, and water” (section 419(a)(3)(B)); 
• “[C]onsider hazards that occu r naturally, may be unintentionally introduced, or may be 
intentionally introdu ced, including by act s of terrorism” (sec tion 419(a)(3)(C)); 
• “[T]ake into consideration, consistent with ensuring enforceable public health protection, 
conservation and environmental practice sta ndards and policies established by Federal 
natural resource conservati on, wildlife conservation, and environmental agencies” 
(section 419(a)(3)(D)); 
• “[I]n the case of production that is certified organic, not in clude any requirements that 
conflict with or duplicate the requirements of the national organic program established 
under the Organic Foods Production Act of 1990, while providing the same level of 
public health protection as the require ments under guidance documents, including 
guidance documents regarding action levels, and regulations under the FDA Food Safety 
Modernization Act” (section 419(a)(3)(E)); and 
• “[D]efine, for purposes of [section 419], the terms ‘small business’ and ‘very small 
business’” (section 419(a)(3)(F)). 
Furthermore, section 419(b) of the FD&C Act establishes additional requirements that the final regulation:  
• “[P]rovide for minimum science-based standard s for those types of fruits and vegetables, 
including specific mixes or cate gories of fruits and vegetables , that are raw agricultural 54 
 
commodities, based on known safety risks, which may include a history of foodborne 
illness outbreaks” (section 419(b)(1)); 
• “[P]rovide for coordination of education a nd enforcement activities by State and local 
officials, as designated by the Governors of  the respective States  or the appropriate 
elected State official as recognized by State statute” (section 419(b)(2)(A)); and  
• “[I]nclude a description of the variance process under [sect ion 419(c)] and the types of 
permissible variances the Secretary may grant” (section 419(b)(2)(B)). 
In section 419(c), the FD&C Act establishes criteria for the fina l regulation, including that the 
final regulation: 
• “[S]et forth those procedures, processes, and practices that the Secretary determines to 
minimize the risk of serious adverse h ealth consequences or death, including 
procedures, processes, and practices that the Secretary determines to be reasonably 
necessary to prevent the intr oduction of known or reasonab ly foreseeable biological, 
chemical, and physical hazards, including hazards that occur naturally, may be 
unintentionally introduced, or may be inten tionally introduced, in cluding by acts of 
terrorism, into fruits and vegetables, including specific mixes or cate gories of fruits and 
vegetables, that are raw agricultural commodities and to provide reasonable assurances that the produce is not adulterated under section 402” (section 419(c)(1)(A)); 
• “[P]rovide sufficient flexibility  to be practicable for all si zes and types of businesses, 
including small businesses such as a sma ll food processing facility co-located on a 
farm”  (section 419(c)(1)(B)); 
• “[C]omply with chapter 35 of title 44, United States Code (commonly known as the 
‘Paperwork Reduction Act’), with special at tention to minimizing the burden (as defined 55 
 
in section 3502(2) of such Act) on the bus iness, and collection of information (as 
defined in section 3502(3) of such Act), a ssociated with such regulations” (section 
419(c)(1)(C)); 
• “[A]cknowledge differences in  risk and minimize, as appropriate, the number of 
separate standards that apply to se parate foods” (section 419(c)(1)(D));  
• “[N]ot require a business to hire a consultant or other third party to identify, implement,  
certify, compliance with these pr ocedures, processes, and practic es, except in the case of 
negotiated enforcement resolutions that may re quire such a consulta nt or third party” 
(section 419(c)(1)(E);  
• “[P]ermit States and foreign countries fr om which food is imported into the United 
States to request from the Secretary varian ces from the requirements of the regulations, 
subject to [section 419(c)(2) of the FD&C Act], where th e State or foreign country 
determines that the variance is necessary in  light of local growi ng conditions and that 
the procedures, processes, and practices to be followed under the variance are 
reasonably likely to ensure that the produ ce is not adulterated under section 402 [of the 
FD&C Act] and to provide the same le vel of public health  protection as the 
requirements of the regulations adopted under [section 419(b) of  the FD&C Act]” 
(section 419(c)(1)(F)); and 
• Establish requirements relating to variances, including that: 
o “A State or foreign country from which food is imported into the United States 
may in writing request a variance from the Secretary. Such request shall describe 
the variance requested and present inform ation demonstrating that the variance 
does not increase the likelihood that the f ood for which the variance is requested 56 
 
will be adulterated under section 402, and that the variance provides the same 
level of public health prot ection as the requirements of  the regulations adopted 
under [section 419(b) of the FD&C Act].  The Secretary shall review such 
requests in a reasonable timeframe” (section 419(c)(2)(A)).  
o “The Secretary may approve a variance in whole or in part, as appropriate, and 
may specify the scope of app licability of a variance to other similarly situated 
persons” (section 419(c)(2)(B)).  
o “The Secretary may deny a variance request if the Secretary determines that such 
variance is not reasonably likely to ensu re that the food is not adulterated under 
section 402 and is not reasonably likely to provide the same level of public 
health protection as the requirements of the regulation adopted under [section 
419(b) of the FD&C Act]. The Secretary shall notify the pers on requesting such 
variance of the reasons for the denial” (section 419(c)(2)(C)).  
o “The Secretary, after notice and an opportunity for a hearing, may modify or 
revoke a variance if the S ecretary determines that such variance is not 
reasonably likely to ensure that the food is not adulterated un der section 402 and 
is not reasonably likely to provide the same level of public health protection as 
the requirements of the regulations a dopted under [section 419(b) of the FD&C 
Act]” (section 419(c)(2)(D)). 
In addition, section 105(c) of FSMA creates a new section 30 1(vv) in the FD&C Act (21 
U.S.C. 331(vv)) to prohibit “[t]he failure to co mply with the requirements under section 419 [of 
the FD&C Act].”    
1. Coordination and Consultation Requirements 57 
 
Consistent with section 419(a )(1)(A) of the FD&C Act, F DA has coordinated with the 
Secretary of Agriculture and representati ves of State departments of agriculture (Ref. 34.Ref. 35) 
and consulted with the Secretary of Homeland Security regarding this proposed rule.   
2. Definitions of Small and Very Small Businesses Section 419(a)(3)(F) of the FD&C Act requir es that the regulations define the terms 
“small business” and “very small business.”  These terms are significant because section 419 of FSMA contains provisions sp ecific to such entities. 
• “With respect to small and very small busine sses… that produce and harvest those types 
of fruits and vegetables that are raw ag ricultural commodities that the Secretary has 
determined are low risk and do not present a ri sk of serious adverse health consequences 
or death, the Secretary may determine not to  include production and harvesting of such 
fruits and vegetables in such rulemaking, or  may modify the applicable requirements of 
regulations promulgated pursuant to [secti on 419]” (section 419(a )(1)(B) of the FD&C 
Act). 
• “[T]he regulations promulgated under [secti on 419 of the FD&C Act] shall apply to a 
small business… after the date that is 1 y ear after the effective date of the final 
regulation… [and] to a very small business… after the date that is 2 years after the 
effective date of the final regulation”  (section 419(b)(3) of  the FD&C Act). 
In section V.A. of this document, we discu ss our proposed definitions of small and very 
small business.  In section IV .K. of this document, we discuss our proposal to establish 
compliance dates for small and very small businesse s that are three and f our years, respectively, 
after the effective date of the final regulation, with additional, more ex tended compliance dates 
for certain proposed provisions related to water.  FDA has tentatively deci ded not to exempt or 58 
 
modify the requirements of the proposed rule wi th respect to small and very small businesses 
that produce and harvest certain types of produce based on a determination that such types of 
produce are low risk and do not present a risk of serious adverse health consequences or death 
using the discretionary authority pr ovided by section 419(a)(1)(B).  It is not necessary to use this 
discretionary authority in part because, as disc ussed in section V.A. of this document, FDA 
proposes in § 112.2 to exclude certain types of low risk produce from the coverage of this rule 
without regard to the business size of the fa rm producing and harvesting such produce.  As 
discussed in section IV.C.2. of this document, these exclusions are based on our tentative 
conclusion that science-based minimum standards to  minimize the risk of serious adverse health 
consequences or death from biological hazards in  these commodities are not warranted.  Another 
reason it is not necessary to use the discretionary  authority in section 419(a)(1)(B) is because, as 
discussed in section V.A. of this document, FDA proposes in § 112.4 to apply this regulation 
only to businesses with an averag e annual monetary value of food sold during the previous three-
year period of more than $25,000 on a rolling ba sis, based on a tenta tive conclusion that 
businesses with $25,000 or less in sales do not contribute signif icantly to the produce market 
(1.5% of covered produce acres) an d, therefore, to the volume of  production that could become 
contaminated.  Accordingly, we tentatively conc lude that imposing the proposed requirements on 
these businesses is not warranted because it would have little measurable public health impact.  
We note that such farms would continue to be subject to the applicab le requirements of the 
FD&C Act.  
3. Exemptions and Exceptions Section 419(f)(1) of the FD&C  Act establishes an exemption from the requirements 
under section 419 based on average a nnual monetary value of the food sold directly to “qualified 59 
 
end-users” (as defined in sect ion 419(f)(4)) as compared to al l other buyers and average annual 
monetary value of all food sold.  Section 419( f)(2) establishes requirements for consumer 
notifications with respect to food from exempt  farms, and section 419(f)(3) provides that the 
Secretary may withdraw the exemption in specifie d circumstances.  In sections V.A and V.R of 
this document, we discuss proposed §§ 112.5 and 112.6, and subpart R, respectively, which 
would implement these provisions of the FD&C Act.  Section 419(g) of the FD&C Ac t states “[t]his section shall not apply to produce that is 
produced by an individual for personal consump tion.”  In section V.A. of this document, we 
discuss proposed § 112.2(a)(2), whic h would implement this provision. 
 Section 419(h) of the FD&C Ac t states “[t]his section shall not apply to activities of a 
facility that are subject to s ection 418.”  In sections III.F a nd V.A.2.b.i of this document we 
discuss proposed § 112.4(a), which would implement this provision.   
4. Intentional Adulteration 
FDA proposes to implement section 105 of FSMA in two regulations, rather than a single 
regulation that covers all hazards relevant to produce.  This rulemaking is not intended to address 
hazards “that may be intentiona lly introduced, including by acts of  terrorism.” (§§ 419(a)(3)(C) 
and (c)(1)(A) of the FD&C Act).  FDA plans to implement section 105 of FSMA regarding such hazards in a separate rulemaking in the future, and intends to consult with the Secretary of 
Homeland Security in that rule making, as required by § 419(a)(1)(A) of the FD&C Act.  FDA 
tentatively concludes that intentional hazards lik ely will require different kinds of controls and 
would be best addressed in a separate rulemaking.   
5. Science-based minimum standard s related to specific topics 60 
 
Consistent with the provisions in Section 419 (a)(3)(B) of the FD&C Act that requires us 
to establish "science-based minimum standards re lated to soil amendments, hygiene, packaging, 
temperature controls, animals in the growing ar ea, and water," this proposed rule addresses 
specific topics relevant to produc tion and harvesting of produce on farms.  We address standards 
related to soil amendments in subpart F; standards for hygiene in subpart D, standards for 
animals in the growing area in subpart I; and st andards for water in subpart E.  We address 
packaging as part of our proposed standards for harvest, packing, and holding activities in 
subpart K; and temperature controls as part of  our proposed standards fo r agricultural water in 
subpart E. 
6. Providing Sufficient Flexib ility to be Practicable 
As required by section 419(a )(3)(A) and (c)(1)(B), this proposed rule would provide 
sufficient flexibility to be pract icable for all sizes and types of  entities engaged in the production 
and harvesting of fruits and vegetables that are raw agricultural commodities, including small 
businesses and entities that sell directly to c onsumers, and is appropriate to the scale and 
diversity of the production and ha rvesting of such commodities.   
As discussed in section IV of this document,  we have chosen a re gulatory approach that 
provides significant flexibility.  We propose a vari ety of different types of measures (including 
GMP-type measures, numeri cal standards, requirements to m onitor and take action under certain 
circumstances, and written plans)  to tailor the requirements of  the proposed rule appropriately 
and to be practical for the diversity of farm s and commodities that would be covered by the 
proposed rule.   
Wherever possible, we have also attempted to fashion this regulation to be as flexible as 
possible to accommodate future changes in science and technol ogy and the particularities of 61 
 
local growing conditions and commodities.  As di scussed in section V.B of this document, in 
proposed § 112.12, we list the specific  requirements established in this rule for which we would 
allow alternatives to be established and used in appropriate circumstances.   This provision would 
provide significant flexibility by allowing individual farms to develop alternative standards 
suitable to their operations with appropriate scientific  support.  In addition, consistent with 
sections 419(c)(1)(F) and (c)(2) of the FD&C Act, in pr oposed subpart P, we provide for a 
mechanism by which a State or a foreign countr y from which food is imported into the United 
States may request a variance from one or more  requirements proposed in this part, where the 
State or foreign country determines that: (a) the variance is necessary in light of local growing 
conditions; and (b) the procedures, processes, an d practices to be follo wed under the variance are 
reasonably likely to ensure that the produce is  not adulterated under S ection 402 of the Act and 
to provide the same level of public health protec tion as the requirements of this part.  Proposed 
subpart P would provide additional flexibility for alternative practices  to be used where 
appropriate to specific local gr owing conditions and commodities. 
7. Use of Third Parties In accordance with section 419(c)(1)(E) of the FD&C Act, we are not proposing to 
require a farm to hire a consulta nt or third party to identify, im plement, certify, or comply with 
these produce safety standards.  These standards are intended to be capable of implementation by 
those who engage in routine ac tivities on the farm.  As discu ssed in section II.D.1 and V.Q., 
FDA has, together with USDA AMS, establ ished a jointly funded Produce Safety Alliance 
(PSA), a public-private partnershi p that will develop and dissem inate science- and risk-based 
training and education programs to provide produce farms with fundamental food safety 
knowledge.  Education and outreach through m echanisms like PSA and other sources of 62 
 
information that are familiar to the produce fa rming community (such as Cooperative Extension, 
land grant universities and trade associations ) is the foundation of our intended compliance 
strategy.  Through these mechanisms, FDA aims to  assist farmers in gaining the food safety 
knowledge they will need to comply with the pr ovisions of a final produce safety rule.   
8. Consideration of Environmental Standards 
As required by section 419( a)(3)(D), in developing these produ ce safety standards and consistent 
with ensuring enforceable public health protectio n, we took into consideration conservation and 
environmental practice standards and policie s established by Federal natural resource 
conservation, wildlife conservation, and environmen tal agencies.  In deve loping this rule, we 
consulted with USDA’s National Organic Program and Natural Resources Conservation Service, 
U.S. Fish and Wildlife Service, and the EPA to take into consideration conservation and 
environmental practice standards and po licies established by those agencies (Ref. 34).  Our 
proposed requirements encourage the application of practices that can enhance food safety, 
including sustainable conservation practices.  Add itionally, as discussed in section V.E of this 
document, this proposed rule is designed to be compatible with existing conservation practices in 
the management of agricultural water systems.  Moreover, as discussed in section V.I of this 
document, this proposed rule woul d not require the destru ction of habitat or the clearing of farm 
borders around outdoor growi ng areas or drainages. 
9. Consistency with National Organic Program 
In accordance with section 419(a)(3)(E), this proposed rule does not include any 
requirements that conflict with or duplicate th e requirements of the National Organic Program.  
In developing this proposed rule, we consulted with technical experts a nd representatives from 
the National Organic Program (Ref. 34).  Compliance with the provisi ons of this proposed rule 63 
 
would not preclude compliance with the requireme nts for organic certification in 7 CFR part 
205.  Moreover, where this proposed rule and the National Organic Program would include 
similar or related requirements, we propose that our requirements may be satisfied concurrently 
with those of the National Organic Program (i.e.,  to the extent the requirements are the same, 
compliance with this proposed rule could be achieved without duplication).   For example, 
proposed § 112.54(c) would establish multiple opti ons for composting processes used to treat 
biological soil amendments of animal origin used to grow covered produce, including two 
options (§§ 112.54(c)(1) and (2)) that  are consistent with the opti ons available to USDA-certified 
organic farms under the National Organic Prog ram regulations in 7 CFR 205.203(c)(2).   
As another example, the National Organic Pr ogram application inte rvals for the use of 
raw manure as a soil amendment in 7 CFR 205.203(c)(1) are 90 days and 120 days before harvest, depending on whether the edible portion of the crop contacts the soil.  Proposed § 
112.56(a)(1)(i) would require a 9 month applica tion interval for use of raw manure in the 
growing of covered produce when  application is performed in a manner that does not contact 
covered produce during application and minimizes the potential for contact with covered produce 
after application.  Proposed § 112.56(a )(1)(ii) would not require an ap plication interv al for use of 
raw manure in the growing of covered produce when  application is performed in a manner that 
does not contact covered produce during or afte r application.  For certified organic farms 
growing produce that would be subject to this rule, the National Orga nic Program application 
intervals would run concurrently with the proposed application in terval in this proposed rule, 
rather than consecutively.  Organic farms (like ot her farms) using raw manure would either need 
to wait 9 months between application and harv est and use application methods meeting the 
proposed requirements for avoiding and minimizi ng contact between covered produce and raw 64 
 
manure, or apply the raw manure in a manner th at does not contact covered produce during or 
after application.  Doing so w ould not jeopardize their complian ce with the requirements of the 
National Organic Program.   
In addition, this proposed rule would esta blish in proposed § 112.163 that records kept 
for other purposes could be used to satisfy the re cordkeeping requirements in this proposed rule.  
Accordingly, records kept under 7 CFR 205.103 for the purposes of the National Organic 
Program that contain information that would be  required in records unde r this proposed rule 
would not need to be duplicated.   
Further, while not critical  to our conclusion regarding compliance with section 
419(a)(3)(E) of the FD&C Act, we note that th e provisions of the propos ed rule are not in 
conflict with or duplicative of the non-bindi ng recommendations of the National Organic 
Standards Board’s Compost Tea Task Force (Ref. 36).  Certified organic farms would be able to 
comply with the provisions of th is proposed rule with respect to their use of agricultural teas 
while simultaneously meeting or exceeding the non-binding recomme ndations in the NOSB 
Compost Tea Task Force Report.   We seek comment on our approach to ensuring that this proposed rule does  not conflict with or 
duplicate the requirements of the National Organic Program while providing the same level of 
public health protection as required under FSMA.   
10. Minimizing PRA burden In implementing section 419 of the FD&C Act through this proposed rule, FDA has 
complied with chapter 35 of title 44, United States code (commonly known as the “Paperwork Reduction Act” (PRA)), with special attention to  minimizing the burden (as defined in section 
3502(2) of such Act (44 U.S.C. 3502(2)) on the faci lity, and collection of information (as defined 65 
 
in section 3502(3) of such Act (44 U.S.C. 3502(3 )), associated with the proposed rule.  Under 
section 3502(2) of the PRA, “burden” means the “time, effort, or financial resources expended 
by persons to generate, maintain, or provide information to or for a Federal agency.”  Under 
section 3502(3) of the PRA, “collection of informa tion” means, in releva nt part, “the obtaining, 
causing to be obtained, soliciting, or  requiring the disclosure to th ird parties or the public, of 
facts or opinions by or for an agency, regardless of  form or format, calling for . . . . answers to 
identical questions posed to, or  identical reporting or recordkeeping requirements imposed on, 
ten or more persons. . . . .”  In section X of this document, we discuss how this proposed rule 
complies with the requirements of the PRA.  In  addition, in implementing section 419 of the 
FD&C Act, we have paid special attention to  minimizing burden and collection of information 
associated with this proposed rule. 
As discussed above, we are proposing requirement s that provide significant flexibility for 
different sizes and types of farms.  By ma king these requirements flexible enough to be 
practicable for different sizes and types of farms, the proposed  rule also avoids creating 
unnecessary information collection burden for entitie s, because farms should be able to tailor 
their recordkeeping to their specific circumstance s while still complying with the requirements of 
the proposed rule. In addition, as discussed in se ction IV.E. of this document, the only requirements we are 
proposing that constitute collections of informa tion are those that are necessary to implement 
section 419 of the FD&C Act and for the efficien t enforcement of the FD&C Act.  We propose 
to require records under th is rule only in instances where main tenance of detailed information is 
needed to keep track of measures directed at  minimizing the risk of a known or reasonably 
foreseeable hazards, where identific ation of a pattern of problems is important to minimizing the 66 
 
risk of such hazards, or where they are important  to facilitate verifica tion and compliance with 
standards and this cannot be eff ectively done by means other than a review of records.  These 
instances are discussed in more detail in secti on IV.E. of this document and throughout section V 
of this document.  In addition, although we reco gnize their value and encour age their use, we are 
not proposing to require farms to conduct operati onal assessments or to develop written food 
safety plans akin to similar requirements for faci lities subject to section 418 of the FD&C Act or 
our juice HACCP or seafood HACCP regulations.   
 B. Other Provisions of the Federal Food, Drug, and Cosmetic Act FDA’s authority for this propos ed rule also derives from sections 402(a)(3), 402(a)(4), 
and 701(a) of the FD&C Act.  Section 402(a)(3) of  the FD&C Act provides that a food is 
adulterated if it consists in whole or in part of any filthy, putrid, or decomposed substance, or if it 
is otherwise unfit for food.  S ection 402(a)(4) of the FD&C Act provides that a food is 
adulterated if it has been prepared, packed, or  held under insanitary conditions whereby it may 
have become contaminated with filth, or whereby it may have been rendered injurious to health.  
Under section 701(a) of the FD&C Act, FDA is au thorized to issue regulat ions for the efficient 
enforcement of the FD&C Act.   The propos ed rule includes many requirements that are 
necessary to prevent food from being adulterated (eit her because it consists in whole or in part of 
a filthy, putrid, or decomposed substance, because  it is otherwise unfit for food, or because it has 
been held under insanitary conditions whereby it may have become contaminated with filth, or 
whereby it may have been rendered injurious to hea lth).  A regulation that requires measures to 
prevent food from being held under insanitary cond itions whereby either of the proscribed results 
may occur allows for the efficient enforcement of the FD&C Act.  S ee, e.g., regulations to 67 
 
require HACCP systems for fish and fishery pr oducts (21 CFR Part 123) and juice (part 120), 
regulations to require a safe handling statement on cartons of shell eggs  that have not been 
treated to destroy Salmonella organisms and to requi re refrigeration of shell eggs held for retail 
distribution (parts 101 and 115), an d regulations for the production, storage, and transportation of 
shell eggs (part 118). 
 C. The Public Health Service Act In addition to the FD&C Act, FDA’s legal au thority for the proposed rule derives from 
the PHS Act.  Authority under the PHS Act for the proposed regulations is derived from the 
provisions of sections 311, 361, and 368 (42 U.S.C. 243, 264, and 271) that relate to 
communicable disease.  The PHS Act authorizes  the Secretary to make and enforce such 
regulations as ‘‘are necessary  to prevent the introduction, transmission, or spread of 
communicable diseases from foreign countries into  the States … or from one State … into any 
other State’’ (section 361(a) of the PHS Act). (S ee sec. 1, Reorg. Plan No. 3 of 1966 at 42 U.S.C. 
202 for transfer of authority from the Surgeon General to the Secretar y; see 21 CFR 5.10(a)(4) 
for delegation from the Secretary to FDA.)  The provisions in the proposed rule are necessary to 
prevent food from being contaminated with  human pathogens such as Salmonella, L. 
monocytogenes, and E. coli O157, and therefore to prevent the introduction, transmission, or 
spread of communicable disease from foreign count ries into the United States, or from one state 
in the United States to another.   As discussed in section II of this document, without appropriate 
prevention steps, certain pract ices on farms can lead to th e contamination of food with 
pathogens, increasing the likelihood of foodborne illness.  We te ntatively conclude that the 
proposed provisions in this document are necessa ry to prevent the spread of communicable 68 
 
disease and to prevent food from containing f ilthy, putrid, or decomposed substances; being 
otherwise unfit for food, or being prepared, pack ed, or held under insanitary conditions whereby 
it may have become contaminated with filth, or whereby it may have been rendered injurious to 
health.  
 D. Legal Authority for Records Requirements We are proposing to use our authority under the FD&C Act and the PHS Act to institute 
certain records requirements as follows:   
• For covered produce that is exempted from th e requirements of the proposed rule because 
it receives commercial processing that adequately reduces the presence of 
microorganisms of public health significance, the identity of the recipient that receives 
this produce (§ 112.2); 
• For alternatives that farms may establish and use for certain requirements of the proposed 
rule, the scientific data a nd information used to support such alternatives (§ 112.12).  
• Documentation of compliance with certain requ irements related to training of personnel 
(§ 112.30); water monitoring and testing (§  112.50); biological soil amendments of 
animal origin (§ 112.60); sanitizing of equipmen t used in growing operations for sprouts, 
or for covered harvest, packing, or hold ing activities (§ 112.1 40), and sprouts (§ 
112.150); and 
• General requirements in subpart O that apply to records required to  be established and 
maintained.   As discussed further in sections V.A., V.B ., V.C., V.E., V.F., V.L ., V.M., and V.O. of 
this document, the proposed recordkeeping requ irements are necessary for covered farms to 69 
 
ensure their own compliance with these aspects of the proposed rule  and for FDA to ensure that 
covered farms are complying with the same asp ects of the proposed rule.  Therefore, these 
proposed requirements are necessary for the effi cient enforcement of the FD&C Act because 
they will aid both farms and FDA in ensuring that  food is not adulterate d, and are necessary to 
prevent the spread of communicable disease because they will aid both farms and FDA in 
ensuring that food does not become c ontaminated with human pathogens. 
In addition to having the authority under the FD&C Act and the PHS Act to require this 
recordkeeping, we also have the authority to  require access to the records. Because the 
underlying requirements are necessary to minimize the likelihood of adulteration and the spread 
of communicable disease, access to records that demonstrate that a farm has followed those requirements is essential to confirm compliance and achieve the full benefits of the rule. We also 
have the authority to copy the records when n ecessary. 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 ar e unable to copy the record s, we would have to 
rely solely on our investigators' notes and reports when drawing conclusions. In addition, 
copying records will facilitate follow up regulator y actions. Therefore, we have tentatively 
concluded that the ability to acce ss and copy records is necessary to  enforce the rule and prevent 
adulteration and the spread of communicable dis ease.  In other relevant sections of this 
document, we explain in more detail the recordk eeping provisions that we believe are necessary 
and, because they are limited to wh at is necessary, that we beli eve do not create an unreasonable 
recordkeeping burden. 
 
 F. Intrastate Activities 70 
 
FDA tentatively concludes that the provisions in the proposed rule should be applicable 
to activities that are intrastate  in character.  The plain language  of section 419 of the FD&C Act 
directs FDA to establish sc ience-based minimum standard s for the safe production and 
harvesting of fruit and vegetable RACs to mi nimize the risk of se rious adverse health 
consequences or death.  Secti on 419 does not include a limitation to interstate commerce.  In 
addition, the exemption provided in  section 419(f) of the FD&C Act, based in part on the 
proportion of a farm’s sales made to restaurants or retail food establishments intrastate or within 
275 miles, suggests that Congre ss intended the rule issued un der section 419 to apply to 
intrastate commerce because otherwise there w ould be no need to provide an exemption for 
farms whose sales are intrastate  in character.  In addition, section 301(vv) of the FD&C Act 
provides that “[t]he failure to  comply with the requirements  under section 419”, or the causing 
thereof, is a prohibited act.  Section 301(vv) does not require an interstate commerce nexus.  
Notably, other subsections in section 301 of the FD&C Act, and section 304 of the FD&C Act 
(21 U.S.C 334) demonstrate that  Congress has included a specific interstate commerce nexus in 
the provisions of the FD&C Act when that is its intent.  Accordingly, it is  reasonable to interpret 
sections 419 and 301(vv) of the FD&C Act as not  limiting the application of the proposed rule 
only to those farms with a direct co nnection to interstate commerce.   
FDA is mindful that its interpretation of FSMA and the FD&C Act should not cast doubt 
on the constitutionality of those statutes. (See Solid Waste Agency of Northern Cook County v. 
U.S., 531 U.S. 159 (2001)).  FDA has considered the relevant provision s of FSMA and the 
FD&C Act, FDA's responsibilitie s in implementing those statutes , and the law interpreting the 
commerce clause of the Constitutio n (Article I, section 8).  C ongress's power to legislate under 
the commerce clause is very broad.  However, such power is not without limits, see United 71 
 
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 rele vant and enduring preceden ts.  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 `e nough 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 applicati on of sections 419 and 301( vv) of the FD&C Act, 
as added by section 105 of FSMA.  Accordingly,  given the collective impact on commerce of 
farms that grow, harvest, pack, or hold food th at is sold in “intrastate” commerce, FDA 
tentatively concludes that such farms should be subject to the proposed ru le unless an exemption 
from the rule applies (for example, if the farm is eligible for the qualified exemption in proposed 
§ 112.5, or if the farm only grows produce exem pt from the regulation under one of the 
exemptions in proposed § 112.2).  This outcome is  consistent with section 709 of the FD&C Act 
(21 U.S.C 379a), which states that in any act ion to enforce the act's requirements respecting 
foods, drugs, devices, and cosmetics, any necessa ry connection with interstate commerce is 
presumed.  Likewise, this outcome is consistent with FSMA’s risk-based, pr eventive approach to 
food safety because the risk presented by unsaf e food can be great, whether or not the food 
moves from one state to another.  FDA seeks co mment on the number of so-called “intrastate” 
farms that would not be exempt from the propose d rule either under the proposed exemption in § 
112.5 or as a result of growing only produce that would be exempt under proposed § 112.2. 
 72 
 
 E. Relevance of Section 415 of the FD&C  Act to “Farm” Definition and Related 
Definitions 
Section 419 directs FDA to issue a proposed ru le “for the safe pr oduction and harvesting” 
of certain produce.  Section 419 does not affirm atively identify the bus inesses to which the 
proposed rule must apply, but requires FDA to  address “with respect to growing, harvesting, 
sorting, packing, and storage operations… soil amendments, hygiene, packaging, temperature 
controls, animals in the growing area, and water” (419(a)(3)(B)); frequently uses the term “farm” 
(e.g., section 419(f)); and clarif ies that section 419 does not apply to produce produced by an 
individual for personal consumpti on (section 419(g)) or activities of facilities subject to section 
418 (section 419(h)).  FDA intends to issue a notice of proposed rulemaking implementing section 418 of the FD&C Act (s ection 103 of FSMA) in the near future.  FDA tentatively 
concludes that “activities of fac ilities subject to section 418” ar e those activities triggering the 
requirement to register with FDA under sec tion 415 of the FD&C Act (21 U.S.C. 350d), 
“Registration of Food Facilities.”  FDA therefore tentatively concludes that  it is reasonable to 
apply this proposed rule to farms and activities of farm mixed-type  facilities that are within a 
definition of “farm” consistent with that utilized   in FDA’s implementatio n of section 415 of the 
FD&C Act, except to the extent that such entities are producing fruits and vegetables for their 
own consumption.  In the near future, we plan to  address how we will coor dinate the definitions 
in the section 415 registration re gulations with the definitions we are proposing for the purpose 
of the produce safety proposed rule.  Ultimately, F DA intends that the activities to be regulated 
under this proposed rule will not trigger the requirement to re gister under section 415 of the 
FD&C Act and as a result will no t be “activities of a facility subj ect to section 418,” consistent 
with the requirement in section 419(h).  Moreover, the activities wi thin the definition of “farm” 73 
 
we propose as part of this rulemaking closely tr ack those identified in se ction 419(a)(3)(B), and 
this interpretation is consistent with section 419(f)’s use of the term “farm.” 
Because section 418(o)(2) of the FD&C Act de fines the term “facility” for the purposes 
of section 418 to mean only those facilities re quired to register under section 415 of the FD&C 
Act, FDA tentatively concludes that Congress intended the exem ptions from the registration 
requirement set forth in section 415 and FDA’s implementing regulations in part 1, subpart H 
(including the farm exemption in § 1.226(b)) to be meaningful for the purposes of defining 
section 418’s applicability (and in  turn, section 419’s applicability).  Thus, we tentatively 
conclude that activities within a definition of “farm” consistent  with the definition utilized to 
implement the section 415 registration requirement  are not subject to se ction 418 of the FD&C 
Act, but activities outside such a definition of “farm” are subject to s ection 418 when they cause 
a facility to be required to register with FDA under section 415.  We discuss the proposed 
definition of “farm” and related definitions in section V.A.2.b.i of this  document.  We seek 
comment on these interpretations.  74 
 
IV. Regulatory Approach 
A. Qualitative Assessment of Risk 
As discussed below, we are proposing to adopt an approach that focuses on the likelihood of 
contamination of produce posed by the agricu ltural practices applie d to the crop, while 
exempting only the lowest-risk produce.  We con ducted a qualitative assess ment of risk (QAR) 
of hazards related to produce production and harvesting.  The QAR indicated that produce 
commodities are potentially subject to similar microbiological hazard pathways: commodities can potentially become contaminated from, for ex ample, direct exposure to contaminated water 
or soil amendment.  Therefore, we propose to adopt a regulatory approach for minimizing the 
risks associated with those h azards and, as appropriate, prov ide flexibility for the use of 
alternative measures that woul d provide the same level of pub lic health protection as the 
proposed standard.  
The QAR addressed various questions related to produce safety, including: (1) What are 
the biological hazards of concern in produce that can lead to seri ous adverse health consequences 
or death? (2) How does produce become contaminat ed (i.e., routes of c ontamination) during on-
farm growth, harvesting, and postharvest opera tions? (3) Does the like lihood of contamination 
vary among produce commodity types? (4) Does th e likelihood of illness attributable to produce 
consumption vary among produce commodity types?  (5) What is the impact of postharvest 
practices on the level of contamination at cons umption? (6) What on-farm interventions are 
available to reduce the like lihood of contamination?  
(Ref. 2).  The qualitative assessment of risk 
document is currently being peer reviewed and changes can be reasonabl y anticipated based on 
the peer review.  The peer revi ew plan is available online at 
http://www.fda.gov/ScienceResearch/SpecialTopi cs/PeerReviewofScientificInformationandAsse75 
 
ssments/ucm079120.htm . We will consider peer reviewers' and public comments in finalizing the 
qualitative assessment and this proposed rule.  While data and information available to us at th is time permitted us to conduct only a qualitative 
(not quantitative) assessment, some important conclusions can be drawn, which provide a basis 
for our proposed science-based minimum standa rds for the safe production and harvesting of 
produce commodities.  We provide below a brie f summary of conclusions of the QAR.  
Key conclusions from this assessment are:  
• Produce can be contaminated with biologi cal hazards, and the vast majority of 
produce-related illnesses are associ ated with biological hazards. 
• The most likely routes of contaminati on from growing, harvesting, and on-farm 
postharvest activities are associated w ith seed (for sprouts), water, soil 
amendments, animals, worker health and hygiene, and buildings/equipment. 
• Although some types of produce have been re peatedly associated with outbreaks, 
all types of produce commodities have the potential to become contaminated through one or more of these poten tial routes of contamination. 
• The specific growing, harvesting, and on-farm postharvest conditions and 
practices associated with a produce commod ity influence the potential routes of 
contamination and the likelihood that the gi ven route could lead to contamination 
and illness. Use of poor ag ricultural practices  could lead to contamination and 
illness, even where the potential for contamination is relatively low.  
• Postharvest practices such as cooking (and, possibly certain peeling) before 
consumption may have an impact on the li kelihood of contamina tion of the edible 
portion and the likelihood of illness.   76 
 
 
Hazards of concern in produce  -- The scientific evidence from outbreaks, surveys and published 
literature establish that human pathogens (e.g., Salmonella, pathogenic E.coli, Shigella, 
Cyclospora) constitute a biologi cal hazard with the potential to cause serious adverse health 
consequences or death and result in the vast majority of foodborne  illness known to be associated 
with produce consumption. Potential routes of contamination
 -- Based on our observations duri ng inspections, investigations, 
and surveillance activities and ot her available information, we ha ve grouped the possible routes 
of contamination into five major pathways: Wa ter, 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 rout es of contamination. Although the 
likelihood of contamination varies by commodit y, it appears to be depe ndent on the practices 
employed and, to a lesser extent, on the character istics of the commodity. There appears to be 
greater variability in the lik elihood of contamination among commodities during growing than 
during harvest or after harvest.  Likelihood of exposure
 -- Subsequent to any contamina tion on-farm, consumer and retail 
handling practices and produce consumption rates affect the likelihood that consumers will be 
exposed to contamination.  Postha rvest practices such as cooking (and possibly certain peeling) 
before consumption may have an impact on the likelihood of exposure if indeed the produce is 
contaminated.   77 
 
Risk of illness  – Contaminated produce has the potential to cause illness. However, there are 
differences among commodities in the risk of illness primarily based on the routes of 
contamination associated with the commodity. Produce commodities that are ranked as “higher” ri sk of illness and those ranked as “lower” risk 
of illness share some of the same characteristics.  Both categories include: 
• Crops where the harvestable portion grows in the ground; 
• Row crops where the harvestable po rtion grows on or near the ground; 
• Crops where the harvestable portion grows above the ground; 
• Crops where the harvestable portion grow s on trees, high above the ground; and 
• Crops that are generall y grown without soil. 
Such diversity suggests that sorting commoditie s for risk based only on the manner in which 
commodities grow would be inappropriate. This  diversity also characterizes commodities 
associated with outbreaks. Even within a co mmodity group, physical characteristics (such as 
texture of the fruit) of the commodity that could alter the potential for contamination and, 
therefore, association with an outbr eak, do not always appear to do so. 
 In summary, some produce type s 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 w ith reported foodborne illness.  Likely factors 
contributing to the likelihood of contamination, exposure, and illness include: agricultural 
practices used during growing, ha rvesting, and postharvest; physic al characteristics of the crop; 
consumer and retail handling practices (such as cooking and peeling); and rates of consumption. 78 
 
However, use of poor agricultural practices could lead to contamination and illness, even where 
the potential for contamination is relatively low.  
 
With regard to water as a route of contamination:-- 
• Agricultural water can be a source of contamination of produce. 
• Public Drinking Water Systems (domestically regul ated by the EPA) have the lowest relative 
likelihood of contamination due to existing standards and routine analytical testing. 
• Groundwater has the potential to pose a public health risk, despite the regulation of many 
U.S. public wells being subject to regul ation under the Groun d Water Regulation. 
• There is a significant likelihood that U.S. surf ace waters will contain human pathogens, and 
surface waters pose the highest potential for contamination and the greatest variability in 
quality of the agricultural water sources. 
• Susceptibility to runoff significantly increase s the variability of surface water quality. 
• Water that is applied directly to the harvestable portion of the plant is more likely to 
contaminate produce than water applied by indire ct methods that are not intended to, or not 
likely to, contact produce. 
• Proximity of the harvestable portion of produce to water is a factor  in the likelihood of 
contamination during indirect application. 
• Timing of water application in produce production before consumption is an important factor 
in determining likelihood of contamination. 
• Commodity type (growth characteristics, e .g. near to ground) and surface properties (e.g., 
porosity) affect the probability and degree of contamination. 79 
 
• Microbial quality of source waters, method of application, and timing of application are key 
determinants in assessing rela tive likelihood of cont amination attributable to agricultural 
water use practices. 
 
With regard to soil amendments as a route of contamination-- 
• Soil amendments can be a source of contamination to produce 
• Biological soil amendments of animal origin have a greate r likelihood of containing human 
pathogens than do chemical or physical soil am endments or those that do not contain animal 
waste (e.g., plant-based soil amendments). 
• Human waste is the most likely wa ste to contain human pathogens. 
• Animal waste subject to treatments, such  as chemical and physical treatments and 
composting, has relatively lower levels of hu man pathogens than untreated animal waste. 
• Composting is less likely than controlled chemi cal or physical treatments to fully eliminate 
human pathogens from animal waste. 
• Incompletely treated, or re-contaminated, biol ogical soil amendments of  animal origin may 
also contain human pathogens. 
• Human pathogens in untreated or composted bi ological soil amendments, once introduced to 
the growing environment, will eventually die off,  but the rate of die-off is dependent upon a 
number of environmental, regional, and other agro-ecological factors. 
• Treatments, such as chemical and physical tr eatments and composting, can effectively reduce 
the levels of human pathogens in animal waste. 80 
 
• Among application methods, application of soil amendments in a manner in which they 
contact the harvestable portion of the crop pres ents the greatest likel ihood of contamination, 
especially when applied close to harvest. 
 
With regard to animals as a route of contamination-- 
• Animals can be a source of contamination to produce. 
• Animal excreta poses a high likeli hood of contamination of produce. 
• Excreta from domesticated animals poses a gr eater likelihood of c ontamination of produce 
than does excreta of wild animals. However, domesticated animals can be expected to be 
more readily controlled (i.e., ke pt apart from produce growing,  harvesting, and postharvest 
areas). 
• Excreta from wild animals that rarely asso ciate with human activities poses the least 
likelihood of contamination of produce. 
• Human pathogens from animal excreta, once in troduced to the growing environment, can be 
expected to eventually die off; but the ra te of die-off is depe ndent upon a number of 
environmental, regional, and ot her agro-ecological factors. 
 
With regard to worker health and hyg iene as a route of contamination-- 
• Humans (i.e., workers and visitors) are potenti al carriers of foodborne pathogens and can be 
a source of contamination of produce.  
• Individuals with communicable diseases that  can be spread via food who are engaged in 
activities in which they contact  produce or food contact surfaces  can result in contamination 
of the produce or food-contact su rfaces with human pathogens. 81 
 
• Hand-washing reduces the potential for cont amination of produce. Its efficacy varies 
depending upon the use of soap, th e quality of the water, and wh ether or not hands are dried 
after washing.  
• Dirty and damaged gloves may contaminate produce.  
• Workers or visitors that touch animals can  contaminate produce or food contact surfaces.  
• Poor hygienic practices, e.g. l ack of hand washing, can lead to contamination of produce.  
• The presence of adequate toilet facilities in reasonable proximity to growing areas can reduce 
produce contamination. 
 
With regard to equipment and buildin gs as a route of contamination-- 
• Food contact surfaces are potential r outes of contamination of produce. 
• Food contact surfaces such as equipment that are designed and constructed to be cleanable 
minimize the potential for contamination of produce. 
• Pests in buildings used to grow or pack produ ce can be a source of contamination of produce. 
• Waste material can be a source of contamination,  or may become an attractant for pests and 
thereby act as a source of contamination to pr oduce, if not properly contained, stored and 
conveyed. 
The provisions proposed in section V of th is document reflect the above conclusions 
drawn from our qualitative a ssessment of risk.  We seek public comment on the QAR, 
conclusions drawn from that assessment, and our consideration of those conclusions in 
developing the proposed requireme nts.  We also request you to submit any data or factual 
information that may help the agency to  conduct, as warranted, a thorough and robust 
quantitative assessment of risk associated wi th produce production and harvesting practices.  82 
 
 
B. Focus on Biological Hazards  
Section 419 of the FD&C Act directs us to establish science-base d minimum standards 
for the safe production and harvesting of those types of fruit and vegetable raw agricultural 
commodities (RACs) for which we determine that such standards minimize the risk of serious 
adverse health consequences or death (section 419(a)(1 )(A) of the FD&C Act) .  These standards 
are to be based on known safety risks and to include  procedures, processes, and practices that we 
determine to be reasonably necessary to prevent the introduction of known or reasonably foreseeable biological, chemical, and physical ha zards into fruit and vegetable RACs and to 
provide reasonable assurances that produce will not be adulterated under section 402 of the FD&C Act (sections 419 (b)(1) and 4 19(c)(1)(A) of the FD&C Act).    
As discussed in the QAR, available data a nd information clearly establish that human 
pathogens constitute a biological hazard with th e potential to cause serious adverse health 
consequences or death and result in the vast majority of foodborne  illness known to be associated 
with produce consumption.  By contrast, chemical , physical, and radiological hazards associated 
with produce rarely pose a risk of serious advers e health consequences or  death for individuals 
that would consume the product 
(Ref. 7).  Section 419(c)(1)(A) of the FD&C Act requires FDA 
to “set forth those procedures, pr ocesses, and practices that the Secretary determines to minimize 
the risk of serious adverse health consequences  or death, including proc edures, processes, and 
practices that the Secretary determines to be re asonably necessary to pr event the introduction of 
known or reasonably foreseeable biological, chem ical, and physical hazards… and to provide 
reasonable assurances that the produce is not adulte rated under section 402 [of the FD&C Act].”   
The frequency and nature of chemical, physical , and radiological hazards in produce are such 83 
 
that promulgation of a new regulatory regime for th eir control does not, at this time, appear to be 
reasonably necessary to prevent their introdu ction into produce or to provide reasonable 
assurances that produce will not be adulterated under section 402 of the Act.  FDA tentatively 
concludes that existing programs, such as EPA re gistration of pesticides , and State and industry 
efforts to control the presence of pesticides a nd mycotoxins in produce, are sufficient to keep 
these hazards under control.  In addition, under its broader food safety regulatory framework, 
FDA monitors natural toxi ns (e.g., mycotoxins), pesticides, i ndustrial chemicals (such as dioxins; 
cooking or heating related chemicals, such as ac rylamide), and other chemical contaminants, and 
radionuclides in foods. 
For these reasons, we tentativ ely conclude that the proposed  rule should be limited in 
scope to biological hazards and science-based standards necessary to minimize the risk of serious adverse health consequences or death associated  with biological haza rds.  Because of the 
proposed rule's focus on biological hazards, and because of the effectiveness of cooking and 
similar processes on the reduction of the likeli hood of contamination of  such hazards, as 
described in the Qualitative Assessment of Ris k, we also propose to exempt produce that is 
rarely consumed raw or that receives commerc ial processing that ad equately reduces the 
presence of microorganisms of public health sign ificance (see section V. A. of this document).     
We request comment on this approach, and specifically on whether there are practices 
that are reasonably necessary to prevent the in troduction of known or reasonably foreseeable 
chemical, physical or radiological hazards into  produce or otherwise to provide reasonable 
assurances that produce is not  adulterated under section 402 of the FD &C Act because of 
chemical, physical, or radiological hazards.  For example, proposed § 112.11 would require 
covered farms to take appropriate measures to minimize risks of serious adverse health 84 
 
consequences or death from the use of, or exposur e to, covered produce attributable to biological 
hazards that may arise unexpectedly and therefore not be reflected in  a specific standard set forth 
in proposed subparts C to O of this rule, or wh en there are biological hazards specific to a 
covered farm’s location or circumstances for whic h such measures would be appropriate.  Should 
§ 112.11 also apply, for example, in the event of an accident or other unexpected event, such as a likelihood of radiological contaminat ion relevant to a covered farm’s  location, to require that the 
covered farm take appropriate measures to prev ent the introduction of ra diological hazards into 
or onto the produce or by taking measures to provi de reasonable assurances that the produce is 
not adulterated under section 402 of the FD&C Act?   Such measures might include, for example, 
preventing covered produce from entering commer ce if it may have been contaminated with 
radiological hazards that may render it injurious to  health.  As another example, if a covered 
farm’s land was previously used for another activ ity that may have contaminated the soil with 
chemical hazards such that using the land to grow covered produce may cause introduction of 
those hazards into or onto the covered pr oduce, should proposed § 112.11 require the covered 
farm to take appropriate measures to prevent the introduction of the chemical hazards into or 
onto the produce or by taking measures to provide reasonable assurances that the produce is not 
adulterated under section 402 of the FD&C Act?  Such meas ures might include, for example, 
collecting and analyzing soil sample s for residues of pesticides th at are typically used in the 
production of cotton, if you intend to use a former  cotton field for produ ce production.  We seek 
comment on whether, and to what extent, chemi cal, physical or radiologi cal hazards should be 
covered within the scope of this rule. 
 C. Consideration of Differing Risk of Different Commodities and Practices 85 
 
Section 419 of the FD&C Act also directs us to  establish requirements that would provide 
sufficient flexibility to be applicable to vari ous types of entities enga ged in the production and 
harvesting of fruit and vegetable RACs, including small businesses and entities that sell directly 
to consumers, and to be appropr iate to the scale and diversity of the production and harvesting of 
such commodities (section 419(a)(3 )(A) of the FD&C Act).  Sec tion 419 further directs us to 
acknowledge differences in risk while minimizin g, as appropriate, the number of separate 
standards we apply to separate foods (section 41 9(c)(1)(D) of the FD&C Act).  We considered 
different approaches to determin e how we might most appropriate ly respond to these directives, 
informed by the information contained in the Qu alitative Assessment of Risk.  These primarily 
included:  
• Commodity-specific approach -- covering only those produce commodities or commodity 
groups that might be described as posing a relatively higher ri sk of foodborne illness or 
applying different requirements to commod ity categories based on relative risk of 
foodborne illness represented by the commodity  category (such as higher, moderate and 
lower risk). A benefit of opting to pursue a commodity specific approach would be a 
reduction in the costs of the proposed rule. So me commodities have little or no history of 
links to foodborne illness and, thus, exempti ng them from coverage could reduce costs to 
farmers with little or no reduction in calculated benefits from the rule.  However, because 
foodborne illness outbreaks have regularly b een associated with commodities that have 
previously not been linked to outbreaks, th is approach carries the risk of failing to 
prevent future outbreaks.   
• Integrated approach -- covering all produce commodities except those that pose little or 
no risk of foodborne illness and then appl ying the most stringent requirements to 86 
 
agricultural practices that pos e the greatest likelihood of c ontamination of the produce, 
regardless of the covered produce commodity. A benefit of selecting this option is that 
we would cover all commodities except those that pose little or no risk of foodborne 
illness, an approach that takes into account  the sporadic and unpredictable nature of 
illness outbreaks, while still being sensitive to risk. 
 As discussed below, we explored both a pproaches thoroughly using information available 
to us at this time, and propose to  use an integrated approach.  Based on available data, we have 
not been able to fully develop a commodity-speci fic approach that we believe would adequately 
minimize risk of serious adverse health conse quences or death from biological hazards in 
produce.  However, as discussed in section IV.C .1.b., we have tentatively identified an approach 
based on outbreak data, and we further explore that option in that section.  We welcome 
comment on this approach and ask that you provide data and factual information that would help 
us to further consider developing this or a nother appropriate commodity-specific approach. 
1. Commodity-Specific Approaches  
As noted above, there are multiple possible approaches that we could take with respect to 
produce.  One of them is what we refer to as a “commodity-specific approach” in which this rule would apply only to those produce commodities or commodity groups that pose a relatively higher risk of foodborne illness. (We could also  simply apply different or less stringent 
requirements to the relatively lower-risk commod ities.) In theory, commodities might also be 
grouped into higher, moderate, or lower levels of risk with different leve ls of stringency applied 
to each. As discussed in section IV.A. above , we attempted to categorize commodities and 
commodity groups by risk in our Qualitative Assessment of Risk. 
a. Relative Risk Considerations 87 
 
To fully explore the viability of a commodity-specific approach, we reviewed the relative 
risk of different commodities using four such data sources: Outbreak data; Pathogen surveillance 
data; Commodity characteristics; and Market channe ls.  Our analysis shows that each data source 
presents certain gaps that make  it challenging to develop a commodity-specific approach that 
would adequately minimize risk of serious advers e health consequences or death.  We explain 
our analysis below and request da ta and factual information on how  we might address these gaps 
and further develop and consider a commodity-specific approach.   
i. Outbreak Data and Commodity Risk: We  reviewed FDA’s data on produce-related 
outbreaks and considered categorizing commod ities or commodity groups by risk based on 
documented association of specific produce commodities with specific outbreaks of human illness 
(Ref. 2).  Using this approach, we could exempt certain commodities or commodity 
groups that had never been linked to human illnesses or were only rarely linked to human illness; 
this would allow us to reduce the costs of the rule with little or no reduction in calculated 
benefits.  However, our QAR also leads us to tent atively conclude that past  patterns of outbreaks 
by commodity have limitations which make it challe nging to use as a key determining factor in 
establishing the scope of this pr oposed rule or how its provisions apply.  We briefly discuss the 
reasons here (please refer to th e QAR for more information).  
Our QAR concluded that some produce types are repeatedly associated with reported 
foodborne illness, whereas other produce types are intermittently associated with reported 
foodborne illness.  Still other produce commodities have not b een associated with reported 
foodborne illness.  As such, five commodity grou ps (leafy greens, tomatoes, herbs, melons, and 
sprouts) together account for 77 percent of all produce-related outbr eaks from 1996-2010 (Ref. 
3).  These commodity groups also account for 54 percent of produce-re lated illnesses and 56 88 
 
percent of produce-related hospita lizations. Sprouts account for a quarter of the produce related 
outbreaks (26%), 15 percent of the illnesses, 9 pe rcent of the hospitalizat ions, and one death.   
As discussed in the QAR, because only a sma ll 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 minimi ze current and future risk of illness.  The 
food vehicle responsible for an outbreak is not identif ied in about half of  all outbreaks.  
Identifying the vehicle of an outbreak in which the vehicle is contained in a multi-ingredient food (e.g., salsa, salads) is partic ularly challenging.  As our abili ties to detect outbreaks and to 
identify food vehicles responsible for an out break improve, including re fining our approach to 
outbreaks associated with multi-ingredient foods , it is likely that previously unrecognized 
outbreak vehicles will be identified.  A furthe r complication to use of outbreak data as an 
indication of commodity risk is that, until a food is identified as a vehicle in an outbreak, public 
health officials may not be likely to include que stions about that commod ity when investigating 
an outbreak, making the attribution of outbreaks to commodities with no outbreak history more 
difficult.  
In addition, as discussed in the QAR, our data show that the patterns of outbreaks 
associated with produce commodities change over  time.  Some commoditi es have a continuing 
and repeated pattern of association with outbreak s, over multiple years, such as tomatoes and 
leafy greens 
(Ref. 2).  On the other hand, occasionally a produ ce commodity is associated with an 
outbreak that had not been previ ously linked to foodborne illness.  For example, prior to the 2008 
Salmonella Saintpaul outbreak (Ref. 37), jalapeno and serrano peppers had not been identified as 
vehicles in a foodborne illness outbreak.  Papayas had also not been associated with outbreaks, 
prior to an outbreak that occurred in 2011.  Th erefore, a regulatory appr oach that relied on a 89 
 
static list of commodities prepared solely from  a history of outbreaks would not be able to 
prevent future outbreaks in commodities not pr eviously associated with an outbreak.   
If we adopted an approach that exempted co mmodities without a history of outbreaks, we 
would likely need to add commodities as future ou tbreaks occur.  For example, we could adopt a 
“moving window” approach that would consider  only outbreaks over a given time period. For 
example, we could consider only the outbreaks over the most recent five years at any given time.  
Using such an approach, produce commodities or commodity groups might move onto and off of 
the higher risk list over time based on changes in  outbreak data.  The advantage of such an 
approach could potentially be to recognize and reward effort s by industry segments that 
implement changes in practices contributing to reduced outbreaks associated with their 
commodities, and provide an incenti ve for other industry segments to  enhance the safety of their 
practices.  However, the adoption of such practic es by an industry segment does not change the 
risk posed by the commodity in the absence of such practices, such as when practices are not 
universally adopted or they are discontinued.  In the absence of those practices, illness outbreaks 
may resume.   For example, sprout associated out breaks appeared to decline after release of our 
Sprout Guides in 1999 and, for three years ( 2005 -2007), there were no reported outbreaks 
associated with sprouts, presumably because  of improved practices during the production of 
sprouts (Ref. 3).  However, outbreaks have recurred si nce that time period, possibly because 
practices have regressed to some extent or possibly because of the entry of new sprout growers who were not familiar with the voluntary recommendations in the Sprout Guides and had not adopted them.  In late 2008, there was one sprout-associated Salmonella outbreak; in 2009, a 
Salmonella outbreak associated with sprouts re sulted in more than 200 illnesses; and in 2010, 
there were 3 outbreaks a ssociated with sprouts 
(Ref. 3).  Further, as discussed in the QAR, some 90 
 
commodities (e.g., leafy greens) ar e consistently associated with outbreaks while others (e.g., 
grapes, jalapeno peppers) are only rarely asso ciated with outbreaks. With a moving window 
approach those commodities that only intermitten tly are associated with outbreaks may cycle on 
and off the higher risk list, even though their risk may not have actually changed.  For these 
reasons, we have tentatively c oncluded that a “moving window” a pproach for determining risk 
based on outbreak history is not viable. 
Grouping commodities based on outbreak history also has challenges.  Within a 
commodity group, contamination may have been asso ciated with relatively few types of produce, 
such as cantaloupe and honeydew melons w ithin the melon group, which includes multiple 
species, or more broadly, such as roma, red r ound, plum, and grape tomatoes within the tomato 
group, which consists of multiple va rieties within a single species (Ref. 3).   
Having considered that making exemptions  solely based on outbreak data could 
significantly reduce the costs of the proposed rule with little  or no reduction in calculated 
benefits, we have not selected th is alternative, because we do not believe that the past history of 
outbreaks can be fully predictive of future ou tbreaks. Historically, outbreaks are sometimes 
linked to commodities that had no previous associ ated illnesses. If we were to develop a 
commodity-specific list of covered produce, we c ould add commodities to the list as more data 
became available.  We request comment on whether this option would adequately minimize the risk of serious adverse health consequences or  death and whether it would sufficiently move 
toward a prevention-based food safety system. We request comment on this determination and 
on the specific approaches we have outlined here. We are particularly interested in the marginal 
effects of adopting this approach: if we exem pted commodities based on a history of outbreaks, 91 
 
what would the likely reductions in  the costs of the rule be, and wh at would the likely increase in 
human illnesses be from this approach. 
ii. Pathogen Surveillance Data and Commodity  Risk: As an alternative to categorizing 
and regulating commodities based on outbreak hist ory, we considered using data on levels and 
frequency of pathogen detection, such as by su rveillance sampling assignments in specific 
produce commodities.  As demonstrated in the QAR , this approach would also present a number 
of challenges.  Of most importance, our contam ination data are limited in that most sampling 
programs have focused on produce commodities that have an existing history of known 
outbreaks, providing little additional information about the risk presented by commodities that 
do not have such a history. Given the potential for system failure and sporadic contamination, it 
is probable that testing of other produce co mmodities may eventually lead to positive 
identification of contamination.  For example, when we added cucumbers to our surveillance 
sampling program in 2009, we found a significant number of positive samples for Salmonella 
spp. although, in previous years, cucumbers had not  been identified as th e vehicle of a foodborne 
outbreak in FDA’s database.  We also found pa thogens in and on produce commodities such as 
broccoli, culantro, rapini, and radicchio that ha ve not been currently identified in outbreaks (Ref. 
3).  For this reason, we do not believe that pathogen surveillance data alone can provide 
sufficient information for a risk-based exemp tion from the proposed rule’s provisions. We 
request comment on this determination.  
iii. Commodity Characteristics and Commodity Risk: As an alternative to categorizing 
and regulating commodities based on outbreak history or surveillance data, we also considered using characteristics of produce commodities themselv es, such as growth habit.  In other words, 
if, for example, the risk of illnesses associated w ith tree fruit, were consistently lower than the 92 
 
risk of illness from commodities grown in the soil,  such a distinction might provide the basis of 
an exemption.  However, as demonstrated in  the QAR, we found that it would be extremely 
difficult to make conclusions across commodity groups that are consistent with outbreak and 
surveillance data, in light of the diversity of commodities, practices, and conditions across 
operations.   
Attempts to categorize produce by commod ity characteristics is confounded by the 
outbreak data, which show no consistent pa ttern that can be matched to commodity 
characteristics such as growth habit.  As discussed in the QAR, the characteristics of 
approximately 20 produce commodities associat ed with outbreaks are diverse and include: 
• Crops generally grown without soil, such as sprouts;  
• Crops where the harvestable portion grow s in the ground, such as green onions; 
• Row crops where the harvestable porti on grows on or near the ground, such as 
lettuce, spinach, basil, parsley and cantaloupe;  
• Crops where the harvestable portion grows above the ground, such as tomatoes and 
chili peppers, raspberries and blueberries; and 
• Crops where the harvestable portion grows on trees, high above the ground, such as 
mangoes and almonds.    Moreover, as discussed in the QAR, even within what may be a reasonable set of 
commodities to group together, physical characte ristics of the produce that could alter the 
potential for contamination do not always appear to do so.  For example, within the melon group, 
cantaloupe has a netted rind, whereas honeyde w has a smooth rind, seemingly making it less 
likely to harbor pathogens.  However, bot h have been associated with outbreaks 
(Ref. 3).   93 
 
 In addition, multiple characteristics would ha ve to be considered to create commodity 
groupings, making such an approach very co mplicated.  For example, while growth 
characteristics, such as distance between the edible portion of the pl ant and the ground, may 
make a commodity less likely to  become contaminated through certain routes, (e.g., tree fruit 
may be less vulnerable to contamination from  grazing animals), distance from the ground does 
not necessarily provide an increased level of pr otection against other sources of contamination 
(e.g., direct contact with a crop pr otection spray if the spray mix were made using contaminated 
water).  Furthermore, once the produce commodity is removed from the growing area, it may lose any safety advantage it had in the field base d on growth characteristics if it is exposed to 
routes of contamination such as  poor worker hygiene practices, cont aminated water, or insanitary 
food contact surfaces.  As another example, ma ngoes are an example of a produce commodity 
that may be thought to present relatively low risk  of foodborne illness, but for which poor water 
quality management during insect disinfestation hot water treatment and cooling as part of 
harvest, packing, and holding resulted in an outbreak  
(Ref. 38).  Some physical characteristics of 
produce commodities (e.g., netted rind of cantaloupe or large, rough surface area of some leafy 
greens) may increase the likelihood of contamin ants being trapped and surviving long enough to 
cause illness, but as noted earlier, these char acteristics do not necessarily determine whether 
contamination occurs or persists.   For the reasons described here, we have tent atively determined that such an approach 
cannot serve as the sole basis for a risk-based  exemption from the proposed rule. We request 
comment on this determination and on whether there are known produce characteristics that 
could serve as a reliable and practicable indicator  of contamination and illness risk. We seek 
comment on this issue and data to inform commodity categorization.  94 
 
 iv. Market Channel and Risk: We also cons idered whether different market channels 
might have an impact on the likelihood of contam ination of produce and therefore whether use of 
certain market channels should be a factor in covering or regulating produce in this proposed 
rule.  In particular, we considered whether ther e is a difference in the likelihood of contamination 
of produce that is sold directly  to the consumer or end user (“direct market channels”) as 
compared to that of produce that is sold into other commercial channels.  We are not aware of 
any data that would enable us to  compare the likelihood of  contamination in th ese two situations.  
We tentatively conclude that produce in both direct market ch annels and other commercial 
channels are subject to the same routes of contamination, although the number of opportunities 
for contamination during packing and holding ma y be greater for produc e in other commercial 
channels as compared to produce in direct market  channels if there are greater numbers of touch 
points and handlers in these channels than ther e are in direct market channels.  We seek 
comment on this tentative conclusion.  
 Section 419(f) of the FD&C Act provides a qualified exemption from this proposed rule 
for many farms selling directly to consumers or ot her “qualified end users, ” and as a result, many 
farms that primarily use direct market channels will not be subject to the requirements of this 
proposed rule (with qualifications provided by th e statute).  Because the statutory qualified 
exemption addresses market channels as a possible risk factor, and because we identified no data that would allow us to otherwise use market ch annels as a factor in covering and regulating 
produce under this proposed rule, we tentatively conclude that  we should not otherwise use 
market channels as a basis of risk categorizati on in this proposed rule. We seek comment on this 
tentative conclusion.     b. Considering an Appropriate Commodity-Specific Approach 95 
 
 In the previous section, IV.C .1.a, we discuss four different relative risk considerations 
that might be used to develop an appropriate commodity-specific approach.  Each has a set of 
challenges, as discussed above.  Of  the four, outbreak data provide the most direct representation 
of public health burden, even cons idering the confines associated wi th these data.  In this section 
we further explore how outbreak da ta might be used to identify commodity groups or specific 
commodities to cover in this proposed rule.    One possible commodity-specific approach would be to cover t hose commodity groups 
that have been associated with outbreaks.  Co mmodity groups “associated  with outbreaks” could 
be identified as, for example, commodity groups associated with one or more outbreaks during a 
set period of time.  The remaining commodity gr oups could then either not be subject to the 
proposed rule, or be subject to the proposed ru le but with less stri ngent requirements.  A 
commodity-specific approach that covers the commodity groups associated with outbreaks 
would target the commodity groups that present th e greatest public health burden.  However, as 
discussed above in sec tion IV.C.1.a., there are va rious drawbacks with using outbreak data in 
this way.  For example, because only a small percentage of outbreaks are both reported and assigned to a food vehicle, outbreak data may not  provide a complete picture of the commodities 
upon which we need to focus to minimize current and future risk of illness.   Another possible commodity-specific appr oach that attempts to account for the 
drawbacks of the above approach would be to cover all of the commodities that have been 
identified as associated with an outbreak at a ny time.  Produce commodities that have not been 
identified as associated with an outbreak could th en either not be subject to the proposed rule, or 
be subject to the proposed rule but with less stringen t requirements.  This option would address 
more than the percent of know n outbreaks addressed by the above approach in that it would 96 
 
address all known outbreaks. This approach woul d also significantly reduce the costs of the 
proposed rule by exempting produce categories that  have never been associated with human 
illness.  As discussed above, however, outbreaks have been associated with commodities without 
an illness history.  Although we would expect to use additional data to up date any list we might 
develop of commodities subject to the provisions of the rule, we would expect that this approach 
would not minimize the risk of occurrence of some number of additional outbreaks and illnesses.   We have discussed limitations with each of  the above methods of creating a risk-based 
exemption from the rule. We could also combine tw o or more of the approaches used above to 
create a more holistic picture of risk. For exampl e, we might combine a history of outbreak data 
with the growing characteristics of a commodity or  class of commodity.  Such an approach could 
potentially exempt additional commodities that po se minimal or no risk (in addition to those we 
already considered in the proposed  approach: those specified as ra rely consumed raw, and those 
that are receive commercial processing that ad equately reduces the pr esence of microorganisms 
of public health significance).  If there were  individual commodities or classes of commodities 
that have not been linked to human illness and we had reason to believe that they were unlikely to be linked to human illness in the future, we would consider exempting these commodities or 
classes of commodities from some or all provisions of the rule.  This would reduce the cost of the rule without significantly reduc ing the calculated benefits of the rule. However, we have not 
been able to fully develop an approach that mi ght combine a history of outbreak data with the 
growing characteristics of a commodity or class of commodities to create risk-based exemptions 
from the rule and, thus, minimize the risk of se rious adverse health consequences or death. We 
seek comment on this issue. Is there information in  the QAR that could be used to develop such a 
system of risk-based exemptions? Are there comm odity characteristics or growth conditions that 97 
 
could be used as a basis to develop such a syst em? Do the proposed provisions for variances (see 
section V.P. below) adequate ly address this issue?  
 We ask for comment on all of the above appr oaches, and we especially ask for comment 
on the likely marginal effects of  the different risk-based exemp tions. If we adopted one of the 
approaches above, what would th e likely reductions in the cost s of the proposed rule be, and 
what would the likely increases in human illnesse s be (using our proposed rule as a baseline). 
We also ask for comment on wh ether any of the above approa ches would be sufficiently 
protective of the public health. 
c. Need for additional data and information  We seek comment on our analysis and cons iderations related to considering an 
appropriate commodity-specific approach that would adequately minimize risk of serious 
adverse health consequences or death from biologi cal hazards associated with produce.   We also 
request comment on whether and ho w different relative risk cons iderations, including outbreak 
data, pathogen surveillance data , commodity characteristics and/ or market channels, could be 
used to develop a commodity-specific approach, and data and factual information that would 
address the drawbacks that are di scussed in this secti on IV.C. that may be accounted for in such 
an approach. Specifically, 
 Are there specific commodities or categories of commodities that should be excluded 
from the scope of the rule, based on data rela ted to their relative risk considerations?  
(Note that under our proposed integrated  approach, we propose to exempt certain 
commodities, including a specifi ed list of produce that is rarely consumed raw, and 
produce that receives commercial processing th at adequately reduces the presence of 
microorganisms of public heal th significance; see secti on V.A.2.a. of this rule.) 98 
 
o For example, the QAR ranked certain produce commodities, such as bananas and 
coconuts, as lower risk for illness, in pa rt because such commodities are peeled or 
shelled before consumption in a manner th at can be expected not to transfer 
contamination onto the interior, edible portion of the commodity.  Should such 
commodities be covered by the rule?  Is coverage of these commodities unnecessary?  Should they be covered but subject to a less stringent set of requirements?   
o Certain commodities are ranked in the QAR  as presenting a relatively lower 
likelihood of exposure, in part because su ch commodities have fewer potential routes 
of contamination and/or lo wer potential for contamina tion.   In addition, some 
commodities are not known to have been associated with outbreaks.  Some commodities (for example, pears, grapefruit, oranges, and lemons) meet both of these criteria, considering the rankings and out break data used in the QAR.  Should 
commodities that meet both of these criteria be covered by the rule? Is coverage of 
these commodities unnecessary?  Should th ey be covered but subject to a less 
stringent set of requirements?  How should the rule address the changing nature of 
outbreak data over time? 
o How should the agency account for uncovered commodities in considering a 
commodity-specific approach that relies on outbreak data?  
 Are there pathogen surveillance data fr om sampling programs focusing on produce 
commodities that have no history of known outbr eaks that would be useful in considering 
a commodity-specific approach?   
 Can commodity characteristics be used as a basis to consider a commodity-specific 
approach?  While the outbreak data show no consistent pattern that can be matched to 99 
 
commodity characteristics such as grow th habit, our QAR shows that produce 
commodities that are ranked as higher risk of  illness and those ranked as lower risk of 
illness do share some of the same characteristics.  A further refinement of our assessment might be helpful in developing a commod ity-specific approach based on commodity 
characteristics.  Considering the qualita tive nature of our assessment, are there 
quantitative data sets available that would enab le a further refinement of our assessment?   
 Are produce in both direct market channels a nd other commercial cha nnels subject to the 
same routes of contamination?  Is the number of opportunities fo r contamination during 
packing and holding greater for produce in othe r commercial channels  as compared to 
produce in direct market channels?  If yes, is  this due to greater numbers of touch points 
and handlers in these channels than there ar e in direct market channels, or to other 
factors?   
 Should market channels be used as a basis for risk categorization?  If  so, how?  Is there a 
need to consider market channels in risk categorization, consideri ng that the statutory 
qualified exemption already addresses market  channels as a possible risk factor? 
 Are other data or information available that would otherwise be useful in considering a 
commodity-specific approach? 
   2. Integrated Approach, as Proposed   As discussed in section IV.A. above, our QAR indicates that some produce types are 
repeatedly associated with reported foodborne  illness whereas other produce types are 
intermittently associated with foodborne illness. Stil l other produce commodities have not been 
associated with reported foodborne illness.  Li kely factors contributi ng to the likelihood of 100 
 
contamination, exposure, and illness include: agricultural practices used during growing, 
harvesting, and postharvest; physical characteristic s of the crop; consumer and retail handling 
practices (such as cooking and peeling); and rates of consumption. However, use of poor 
agricultural practices could lead to contamina tion and illness, even where the potential for 
contamination is relatively low.   Therefore, we tentatively c onclude that an integrated approach that focuses on the 
likelihood of contamination of produce posed by th e agricultural practices applied to the crop, 
while exempting the lowest-risk produce, would provide the most  appropriate balance between 
public health protection, flexibilit y, and appropriate management of different levels of risk.  We 
tentatively conclude that contro ls should be tailored, taking into  account the analysis done by the 
farm in certain areas,  to the potential routes of contamination that each commodity presents 
based on the agricultural practices  employed, and the characteristi cs of the commodity and the 
environmental conditions under which it is grown.   
 Based on our QAR, we are able to iden tify certain conditions under which produce 
commodities constitute very low to no risk with respect to biological hazards.  We tentatively 
conclude that, under these conditi ons, science-based minimum standa rds to minimize the risk of 
serious adverse health consequences or deat h from biological hazar ds in produce are not 
warranted.  As described in the QAR, such c onditions include produce that receives commercial 
processing that adequately reduces the presence of  microorganisms of pub lic health significance 
(proposed § 112.2(b)); and produce commodities th at are rarely consumed raw (proposed § 
112.2(a)(1)).  In each of these cases the produ ce can be expected to receive commercial 
processing or other treatments th at significantly minimize the risk  of serious adverse health 
consequences or death from biological haza rds associated with such produce.   101 
 
 In addition, as discussed in section V.A. of this document, FDA proposes in § 112.4 to 
apply this regulation only to bus inesses with an average annual  monetary value of food sold 
during the previous three-year  period of more than $25,000 on a rolling basis, based on a 
tentative conclusion that busines ses with $25,000 or less in sales do not contribute significantly 
to the produce market and, therefore, to th e volume of production that could become 
contaminated.  Accordingly, imposing the pr oposed requirements on these businesses would 
have little measurable public health impact.  In addition to th ese exclusions proposed by FDA, 
section 419(f) of the FD&C Act provides a quali fied exemption for certain farms, which FDA 
proposes to implement in proposed §§ 112.5 and 112.6, and subpart R, as discussed in sections 
V.A. and V.R. of this document.   For produce commodities that would be covere d within the scope of this rule (i.e., 
“covered produce” as defined in proposed § 112.3), we are proposing to establish science-based 
minimum standards to minimize the risk of serious  adverse health conseque nces or death.  Given 
our current understanding of exis ting microbiological hazards and current data limitations, as 
described in our QAR, we have determined th at a regulatory approach  that addresses the 
potential likelihood of contamina tion  posed by procedures, proce sses, and practices employed in 
the growing, harvesting, packing, and holding of  produce commodities will be more effective 
and appropriate than an approach based on the individual commodities’ physical characteristics, 
known record of contamination, or known out break history.  The only commodity-specific 
requirements proposed in this rule are those de signated for sprouts, which have unique growing 
procedures (i.e., warm, moist nutrient-rich en vironment for an extended period of time that 
supports pathogen growth in addition to sprouting)  and, therefore, present a unique risk profile 
(Ref. 16.Ref. 2).  For this reason, and as discussed in  section V.M. of this document, we 102 
 
tentatively conclude that a speci fic set of safety standards (pr oposed subpart M) for this produce 
commodity is warranted.   The requirements of the proposed regulation would be based on identified routes of 
contamination and the associated practices th at affect the likeli hood that produce becomes 
contaminated: agricultural practices that are more likely to contaminate produce would require 
more stringent measures to ensure that the like lihood of contamination is sufficiently minimized.  
For example, as discussed in sec tion V.E. of this document, we are proposing the most stringent 
standards for water that is used in direct cont act with the harvestable portion of covered produce 
during or after harvest activities (when there is little further oppor tunity for pathogen die off) and 
in certain other uses that present significant sa fety risk for the safety of the produce (such as 
irrigation of sprouts); less stri ngent standards for water that di rectly contacts the harvestable 
portion of covered produce (other  than sprouts) during growing activities (when the opportunity 
for pathogen die off is greater);  and no requirements when wate r is used during growing, but 
does not contact the harvestable portion of covered produce (other than sprouts).  Similarly, we 
are proposing to prohibit the use on covered produ ce of biological soil am endments that present 
the greatest likelihood of pathogen contam ination, i.e., untreated human waste 
(Ref. 39).  
Untreated manure or other untreated  biological soil amendments of animal origin, which are less 
likely to be contaminated with human pathogens th an human waste, but are relatively likely to be 
contaminated (Ref. 35.Ref. 36.Ref. 37), would be allowed, subject to stringent requirements; 
manure or other biological soil amendments of an imal origin that have been properly composted 
to reduce the level of pathoge ns contained therein would be  subject to less stringent 
requirements; and certain chemically or physically  treated biological soil amendments of animal 103 
 
origin that receive more robust treatments to el iminate pathogens would be subject to the least 
stringent requirements.     In addition, we are proposing to include othe r measures that would be broadly applicable 
(e.g., personnel qualifications a nd training requirements in propos ed subpart C, health and 
hygiene requirements in proposed subpart D; requ irements for equipment, tools, buildings, and 
sanitation in proposed subpart L)  and the proposed standards for these are consistent for all 
covered growing, harvesting, pack ing, and holding operations.  
 We tentatively conclude that  the appropriate way to minimize the risk of serious adverse 
health consequences or death is to require all covered farms to comply with the standards in this 
proposed rule with regard to all but the lowe st risk produce.  Identifying the higher-risk 
agricultural practices and setting standards in which the stringenc y of the requirement tracks the 
risk of the chosen practices is appropriate from a public health risk mitigation standpoint and would also provide an incentive for farmers to m ove to lower-risk practices where such options 
are available.  We also expect that our proposed  approach is more workable for row crop farmers 
who may grow multiple produce co mmodities than it would be if we were to assign different 
requirements to specific commodities based on th e risk of foodborne illness associated with 
those commodities.  In these types of operati ons, many agricultural practices and agricultural 
inputs (such as water sources a nd distribution systems, soil amendments and their application 
methods) tend to be farm-specific and, thus, re latively consistent across produce commodities on 
a given farm.  Requiring different  measures from row to row based on the produce commodity in 
that row would likely pose a cons iderable burden on such farms.  Setting standard s that enable 
such farms to apply consistent measures to multiple crops is consistent with the statutory provision in section 418(c)(1)(D)  of the FD&C Act that directs the agency to “acknowledge 104 
 
differences in risk and minimize, as appropriate, the number of separate st andards that apply to 
separate foods.” 
 D. Framework of the Rule  
In developing a framework for this proposed ru le we considered various models used in 
proposed and final FDA regulati ons, including those applied in : (1) the existing Current Good 
Manufacturing Practice in Manufact uring, Packing or Holding Huma n Food regulation (current 
21 CFR part 110; “Food CGMP regulation”); (2)  the Production, Storage, and Transportation of 
Shell Eggs regulation (21 CFR part 118; “Shell Egg Regulation”); (3) the Hazard Analysis and 
Critical Control Point (HACCP) Systems (“jui ce HACCP”) regulation (21 CFR part 120); and 
(4) the Fish and Fishery Products (“seafood HACCP ”) regulation (21 CFR part 123).  None of 
these regulations applies to fru its and vegetables at the point at which we propose to regulate 
such food by this regulation (during growing, ha rvesting, packing, and holding on farms), but as 
models they are instructive. 
Generally, the Food CGMP Regulation  sets out mandatory, broad, generally-applicable 
practices and conditions that are re quired to be met, and the criter ia and definitions in that part 
are applicable in determining wh ether the food is adulterated (1) within the meaning of section 
402(a)(3) of the act, in that the food has been ma nufactured under such conditions that it is unfit 
for food, or (2) within the meani ng of section 402(a)(4 ) of the act, in that the food has been 
prepared, packed, or held under insanitary cond itions whereby it may have become contaminated 
with filth, or whereby it may have been rendered in jurious to health.  The criteria and definitions 
in that part are also applicable in determini ng whether a food violates section 361 of the Public 
Health Service Act.  In some instances where the appropriate measures  are universal and well 105 
 
recognized, the cGMP requirements are prescriptive (e.g., the requirement to remove unsecured 
jewelry at § 110.10(a)(4), the requirement that each freezer and cold storage compartment be 
fitted with a temperature indicating thermometer,  temperature measuring device or temperature 
recording device at § 110.40(e)).  However, more commonly, because of the diversity of 
operations subject to the regulati on and the desire to provide flex ibility for operators to put in 
place measures that are best suited to the specif ics of their operation, the cGMP rule sets out 
more general requirements (e.g., the requirement th at persons working in direct contact with food 
conform to hygienic practices to the extent necessary to protect against contamination of the food 
at § 110.10(b), the requirement that food that can support the rapid gr owth of undesirable 
microorganisms be held in a manner that prevents the food from becoming adulterated at § 110.80(b)(3)).  Many provisions of the Shell Egg Re gulation also take a similar approach to the 
Food CGMP Regulation. 
The Juice HACCP and Seafood HACCP Regul ations set out mandatory frameworks 
through which entities subject to th ose regulations assess the hazards  that are reasonably likely to 
occur in their products and processes and design tailo red controls to prevent or eliminate them or 
reduce them to an acceptable level.  These regu lations require the develo pment of a plan, based 
on the assessment of hazards, which incl udes monitoring procedur es, corrective action 
procedures, verification procedur es, and recordkeeping procedures .  The plan also includes the 
identification of the critical control points (CCPs)  where the controls must be applied and critical 
limits, which are the set points fo r the process that must be me t to ensure product safety.   
The Food CGMP Regulation and the Shell Egg Regulation do not use the structure 
applied in the other regulations identified here to ensure that the conditions and practices are 
keeping hazards in check as anticipated (through  hazard analysis, establ ishment of critical 106 
 
control points, monitoring, corrective actions, ve rification, and recordkeep ing in all applicable 
contexts).  The Food CGMP Regulation preceded  the HACCP regulations  and is generally 
thought of as a pre-requisite or foundation to t hose regulations.  That is, it is generally 
recognized that HACCP-type regul ations must build on the f oundation of a good manufacturing 
practice (GMP)-type regulation in order to further reduce the risk  of illness or injury to 
consumers associated with contaminated produce (Ref. 40.Ref. 41).    
In developing the framework for this proposed  rule, we considered the following: 1) the 
produce farming community is very  diverse, including very small and large farms, some with 
significant expertise in the area of  food safety and others with minimal knowledge in the area, 
some located in the U.S. and some abroad; 2) there is a broad range of crops and agricultural practices employed by the produce farming community, such that a measure for addressing an 
on-farm route of contamination for one produce comm odity in one region may not be practical or 
effective for another on-farm route of contam ination, produce commodity or region; 3) this 
proposed rule is the first effort by FDA to regulate the produce farming community – the 
produce farming community does not have the hist ory of regulatory interaction with FDA and 
the same experience with food safety regulations as does the food manufact uring industry; 4) the 
adequacy of some measures to control spec ific known or reasonably foreseeable hazards 
affecting produce is well established, while ot hers are poorly studied, suggesting that future 
research may identify alternative measures that may be more effective and/or efficient; and 5) 
some on-farm routes of contamination occur in  a relatively controlled environment (e.g., a fully 
or partially enclosed building), while others occur in an outdoor environment that may be beyond 
the control of the farm (e.g., an open field), affecti ng the ability of the farm to take measures that 
minimize the likelihood of contamination. 107 
 
Given these considerations, a nd the need to tailor the propos ed requirements to specific 
on-farm routes of contamination (as discussed in  section IV.C of this document), we propose an 
integrated approach that draws on our past expe riences in the regulations discussed above.  In 
some cases, we propose standards that are very similar to those contained in the Food CGMP 
Regulation, especially where th e routes of contamination ar e well-understood and appropriate 
measures are well-established and generally a pplicable across covered produce commodities 
(e.g., personnel qualifications, training, healt h, and hygiene; harvesting, packing, and holding 
activities; equipment, tools, build ings, and sanitation).  We rely on this approach where possible, 
in part, because we tentatively conclude that compliance would be more suitable with this 
regulatory framework (given the diversity of th e industry with respect to size, agricultural 
practices, and knowledge of food sa fety) than would be the case with a more complex framework 
such as one that also required  an individual written plan.  
In other cases, we have proposed specific  numerical standards against which the 
effectiveness of a farm’s measures would be co mpared and actions taken to bring the operation 
into conformance with the standards, as necessa ry (e.g., proposed standards for agricultural water 
in subpart E; biological soil amendments of anim al origin in subpart F;  sprout environmental 
testing and spent sprout irrigati on water testing in subpart M).  We rely on such a numerical 
standards approach where the effectiveness of individual measures  (e.g., protection of 
agricultural water s ources from contamination, establishment of application intervals for certain 
soil amendments, and chemical disinfection treatmen t of seeds before sprouting) is not complete 
or fully known and/or because much of what affects the on-farm route of contamination is outside the control of the farm (e.g., the quality of a particular surface water source).  In some of 
these cases (e.g., composting of biological soil amendments of animal origin in proposed § 108 
 
112.54) we have provided measures that are well established to meet the numerical standard 
under a wide range of conditions, while also re cognizing that other measures, if properly 
validated, may also be suitable (see proposed § 112.12, discussed in section V.B. of this 
document).  Our proposed use of numerical standard s is similar to the requirement for egg testing 
in the Shell Egg Regulation.   
In still other cases, we have proposed a sta ndard that requires the farm to inspect or 
monitor an on-farm route of contamination and ta ke appropriate measures if conditions warrant.  
We rely on such a monitoring approach where the diversity of conditions that can be expected 
relative to an on-farm route of contamination is  very high and it would be impractical and unduly 
restrictive to set out a standa rd that specifies the appropria te measures for each possible 
circumstance (e.g., requirements for monitoring for animal intrusion in proposed § 112.83, requirement for inspection of agricultural water system in proposed § 112.42).  In addition, we propose this approach in instances where furthe r research is needed to fully understand the 
effectiveness of measures to mitigate the risk of serious adverse health consequences or death.  
Our proposed use of inspection and monitoring followed by appropriate corrective action is 
similar to the requirement to monitor for rodent  activity and take correct ive action on egg farms 
in the Shell Egg Regulation (§ 118.4). 
Finally, in still other cases, we propose a stan dard that requires the farm to develop a 
written plan, committing itself to specific measur es (e.g., sprout environmental testing and spent 
sprout irrigation water testing).  We propose th e use of written plans wh ere the details of the 
measures to be taken are more than can be re asonably expected to be retained in memory, 
especially where the details may change over time and a historical record of the evolution of the 
measures is important for the operator to assess whether further changes to the measures are 109 
 
needed (e.g., changes or rotation in the sampling sites for sprout environmental testing).  Such 
plans are also important for the efficient enforcem ent of the standard as they serve as a clear 
commitment on the part of the operator of the farm  to a particular course  of action, against which 
their actual performance can be judged by the re gulator.  Our proposed use of written plans in 
these specific instances is similar to the re quirement for a written Salmonella Enteritidis 
prevention plan on egg farms in the Shell Egg Regulation (§ 118.4). 
We performed a quantitative risk assessment to estimate the predicted effectiveness of 
some of the provisions of the proposed regulation with respect to one example commodity and 
one example pathogen (Ref. 42).  This quantitative risk assessme nt evaluated the combination of 
fresh-cut lettuce, enterohemorrhagic E. coli  (EHEC), and irrigation water (with and without 
proposed measures in place), and concluded th at a number of variables may influence the 
predicted EHEC illnesses associated with fresh-cut lettuce, as defined by the model scenarios that included contamination from irrigation wate r and other environmental sources on the farm, 
and changes in the contamination during the produc t life cycle from farm to consumption.  The 
quantitative risk assessment document is current ly being peer reviewed and changes can be 
reasonably anticipated based on the peer review.  The peer review plan is available online at 
http://www.fda.gov/ScienceResearch/SpecialTopi cs/PeerReviewofScientificInformationandAsse
ssments/ucm079120.htm .  We will consider peer reviewers'  and public comments in finalizing 
the quantitative risk assessment and this proposed rule.  
This rulemaking is not intended to address “h azards that may be intentionally introduced, 
including by acts of terro rism.” (§ 418(b)(2) of the FD&C Act) .  FDA plans to implement section 
103 of FSMA regarding such hazard s in a separate rulemaking in the future.  FDA tentatively 
concludes that intentiona l hazards likely will require differe nt kinds of controls and would be 110 
 
best addressed in a separate rulemaking.  Howe ver, we request comment on whether we should 
include standards relate d to preventing economically motivat ed intentional adulteration of 
produce in this rule.  Is economically motivated  adulteration of produce reasonably likely to 
occur and, if so, by what mechanisms may poten tial hazards be intentionally introduced in 
produce for economic reasons?  If su ch adulteration is reasonably li kely to occur, what standards 
should FDA consider for prev enting such adulteration? 
 E. Records 
We are proposing to require that farms k eep records as a component of the above 
described standards, under certain, limited circum stances.  In determining those circumstances in 
which records are necessary, we considered the st atutory direction in sect ion 419(c)(1)(C) of the 
FD&C Act to comply with the Paperwork Reducti on Act (44 U.S.C. 3501 et  seq.) “with special 
attention to minimizing” the re cordkeeping burden on the business and collection of information 
as defined in that act.  
Records are useful for keepi ng track of detailed information over a period of time.  
Records can identify patterns of problems and, thus , enable a farm to find and correct the source 
of problems.  Records are also useful for investigators during insp ections to determine 
compliance with requirements (e.g., by FDA in vestigators to determ ine compliance with 
requirements that would be established by this ru le, or by a third party au ditor that a farm or 
retailer may voluntarily engage unde r a business arrangement between the farm and the retailer).   
We propose to require records in instances where they are important  to facilitate verification and 
compliance with standards and this cannot be e ffectively done by means ot her than a review of 
records; where identification of  a pattern of problems is impo rtant to minimizing the likelihood 111 
 
of contamination; and where maintenance of deta iled information is need ed by the operator in 
order to minimize the risk of contamination and demonstrate their compliance.   
 F. Farm-specific Food Safety Plans 
Each farm has a unique combination of size, climate, crops grown, current and previous 
use of its own land and nearby land, sources of ag ricultural water, growing, harvesting, packing, 
and holding practices, animal grazi ng, potential for domestic and w ild animals to enter growing 
or packing areas, and sewage or septic system.  Relevant documents on produce safety, such as 
our GAPs Guide 
(Ref. 10), industry CSGs for melons, tomatoes, leafy greens, and green onions 
(Ref. 43.Ref. 44.Ref. 45.Ref. 46), the CA and AZ LGMA (Ref. 31.Ref. 32), the AFDO Model 
Code of Produce Safety (Ref. 20), the Codex Guide (Ref. 47), and Industry Harmonized GAPs 
(Ref. 48.Ref. 49) recommend that a farm tailor its food safety practices to the practices and 
conditions at its indivi dual operation.  In a ddition, many of these documents explicitly 
recommend that a farm conduct an assessment of its growing environment and may specify when 
assessments should be done (e.g., before planti ng, during production, a nd immediately prior to 
harvest) to identify potential food safety hazards in light of its particular commodities, practices 
and conditions (Ref. 43.Ref. 44.Ref. 45.Ref. 46.Ref. 40.Ref. 47).     
Several of these documents further recomm end that a farm use the findings of its 
assessment to help establish a plan to cont rol potential hazards (Ref . 43.Ref. 46.Ref. 48.Ref. 
45.Ref. 49.Ref. 28.Ref. 18)(Ref. 50.Ref. 51).  For example, the introduction to the AFDO Model 
Code notes that a food safety plan should be comm ensurate with the size and complexity of an 
operation and the inherent risks of the commodities grown, along w ith site specific practices and 
conditions.  The purpose of a food safety plan is to establish measures designed to prevent the 112 
 
introduction of known or reasonably foreseeable f ood safety hazards into or onto produce in light 
of the crops, practices, and conditi ons at the physical lo cation of the farm and would include, for 
example, measures applicable to an individual farm for agricultural water, animal grazing, and 
any specific hazards identified in the recomm ended operational assessment.  The FDA draft 
CSGs recommend developing and maintaining writte n food safety plans and SOPs for areas such 
as handling and storage practi ces, field, facility, and vehicl e cleaning and sanitation, and 
employee training programs.  A nu mber of comments to the 2010 FR notice maintained that the 
most effective approach to produce safety woul d be one that incorporates food safety plans 
developed at the operational level.  Conversely, another group of comments questioned the need 
for some industry segments, such as small fa rms or growers of “low risk” commodities to 
develop or implement food safety  plans.  The above-mentioned documents provide guidance or 
recommendations for operators to consider and, as such, do not re present requirements that must 
be met.  We recognize that requ iring covered farms to conduct a hazard analysis and develop a 
food safety plan at the level required in our ju ice and seafood HACCP regul ations, or prescribed 
by section 418 of FSMA for food manufacturing/processing facilities, may not be feasible. We 
also recognize that, at this time,  only limited tools are available to  help with the development of 
on-farm food safety plans.   
Also as noted above, this proposed rule is th e first effort by FDA to regulate the produce 
farming community.  We have tentatively conclude d, in part based on the statutory direction in 
section 419 to establish “minimum science-based standards,” and in recognition of the direction 
to pay special attention to minimizing recordke eping burden and collection of information, that 
the most appropriate approach for this proposed rule is to establish standards of the type 
described in section D above.  We are not pr oposing to require farms to conduct operational 113 
 
assessments or to develop food safety plans akin to similar requirements fo r facilities subject to 
section 418 of FSMA or our juice HACCP or seafood HACCP regulatio ns.  We acknowledge 
that operational assessments and food safety plans have a prominent place in many public and private produce guidance documents, as discussed above.   
The importance of tailoring what you do at an  individual operation to your commodities, 
practices and conditions is commonly accepted, a nd an operational assessment and food safety 
plan could be valuable tools for farms to sel ect and implement those recommendations which are 
appropriate for their circumstances.  While we are not proposing to require farms to conduct an 
operational assessment or develop a food safety  plan, we do recommend that farms do so, 
because this could help farms be more effectiv e in protecting the safety of their produce.  
Further, we request comment on whether we should require that some or all covered 
farms perform operational assessments and/or devel op a food safety plan, and if only some, what 
criteria should be used to se parate those to whom the requir ement would apply from those to 
whom it would not. 
 G. Foreign Farms 
The proposed rule would apply to foreign farms that meet the criteria to be covered farms 
and that grow, harvest, pack, or hold covered produce for import in to the United States.  This is 
protective of public health, as foreign farms have been implicated in foodborne illness outbreaks 
associated with contaminated produce consumed in the United States 
(Ref. 3).  This is also 
consistent with the requirements of section 419 of the FD&C Act, which clearly contemplates 
that the rule issued under that aut hority will apply to foreign farms.  This is apparent in sections 
419(c)(1)(F) and (c)(2), which provide for a variance process in which states or foreign countries 114 
 
from which food is imported into  the US may request variances from FDA.  Foreign countries 
would not be eligible to request variances from this rule if C ongress did not intend the rule to 
apply to farms in foreign countries.   
 H. Consistency with Codex Guidelines 
In developing our proposed approach, we c onsidered the recommendations of relevant 
Codex guidelines, specifically, th e Codex Code of Hygienic Pr actice for Fresh Fruits and 
Vegetables (CAC/RCP 53-2003) (the Codex Code).   Many of the provisions proposed in this 
rule are parallel to or consistent with the reco mmendations in the Codex Code.  For example, like 
our proposed approach of focusing on biological hazards, the Codex Code  (while intended to 
help control microbial, chemical and physical haza rds associated with production of fresh fruits 
and vegetables) pays particular attention to mi nimizing microbial hazards .  It concentrates on 
microbial hazards and addresses physical and chemi cal hazards only in so far as they relate to 
good agricultural and manufacturing practices .  The Codex Code recommends measures 
applicable to all stages of the production of fr esh fruits and vegetables , from primary production 
to packing, with a particular emphasis on those intended to be consumed raw (Section 2.1 of the 
Codex Code).  In proposed § 112.2(a)(1), we propose to exempt a specified list of produce that is 
rarely consumed raw from the scope of this rule.  Similarly, for those commodities not cooked 
before consumption, the Codex Code recommen ds a set of broadly applicable minimum 
standards, with risk-based adjustments.   
With respect to agricultural water, the Codex Code recommends the assessment of 
agricultural water for suitability for use; special attention to irrigation water that is directly 
applied to edible portion, especi ally close to harvest; and use of  clean water for initial stages 115 
 
followed by potable water for later stages duri ng and after harvest, in cluding cooling (Section 
3.2.1.1 of the Codex Code).  Many of the proposed pr ovisions described in section V.E. of this 
document are consistent with  these recommendations.   
As another example, the Codex Code reco mmends that personnel follow health and 
hygiene requirements and that toilet and hand washing and drying facili ties be provided during 
and after harvest, which are reflected in the propo sed provisions described in section V.D. of this 
document.  In addition, the propos ed provisions described in sec tion V.L. of this document and 
the Codex Code both recognize the importance of  proper design, construction, maintenance and 
cleaning of buildings and equipmen t in ensuring produce safety.   
Moreover, the Codex Code recommends that  “manure, biosolids and other natural 
fertilizers which are untreated or partially treat ed may be used only if appropriate corrective 
actions are being adopted to reduce microbial contaminants, such as maximizing the time 
between application and harvest of fresh fru its and vegetables” (Sect ion 3.2.1.2 of the Codex 
Code).  The recommendation to consider maxi mizing time between application of untreated 
amendments and harvest is reflected in proposed provisions described in section V.F. of this 
document, in particular proposed § 112.56, which s tipulates application in tervals for different 
biological soil amendments of animal origin.   
The Codex Code also recommends that “existi ng practices should be  reviewed to assess 
the prevalence and likelihood of uncontrolled deposits  of animal faeces coming into contact with 
crops. Considering this potential source of contam ination, efforts should be made to protect fresh 
produce growing areas from animals.  As far as possible, domestic and wild animal should be excluded from the area” (Section 3.1 of the Code x Code).  We believe that the proposed 
provisions in § 112.82, which requires an adequate  waiting period between grazing by working 116 
 
animals and harvesting when under the circumstan ces there is a reasonab le probability that 
grazing or working animals will contaminat e covered produce, and § 112.83, which requires 
monitoring for wild animal intr usion and assessment of safety  of harvest where significant 
intrusion is evident if under the circumstances there is a reasonable pr obability that animal 
intrusion will contaminate covered produce, are consistent with (though no t identical to) these 
Codex recommendations.   
Furthermore, the proposed requirements related to the maintenance of records (described 
in section V.O. of this document) are in c oncert with the Codex documentation and records 
recommendations for growers and packers, whic h states: “Growers should keep current all 
relevant information on agricu ltural activities such as the site of production, suppliers’ 
information on agricultural inputs, lot numbers of agricu ltural inputs, irrigati on practices, use of 
agricultural chemicals, water quality data, pest control and cleaning schedules for indoor 
establishments, premises, facilitie s, equipment and containers.  Packers should keep current all 
information concerning each lot such as information on incoming materials (e.g. information 
from growers, lot numbers), data on the quality of processing water, pe st control programmes, 
cooling and storage temperatures, chemicals us ed in postharvest treatments, and cleaning 
schedules for premises, facilities, equipment and containers, etc.” (Section 5.7 of the Codex 
Code).  In the discussion throughout section V of this document, we point out where the 
proposed provisions are consistent with these an d other recommendations of the Codex Code.  
 I. Product Testing as a Strate gy to Control Pathogens 
We considered requiring microbiological pr oduct testing either routinely or under 
specific conditions as a strategy to minimize know n or reasonably foreseeable hazards.  While 117 
 
not widely adopted, product te sting is being used by some in the produce industry.  Some 
produce buyers for retail distributors require rout ine microbial testing of  product as a condition 
of sale in their pur chasing specifications (Ref. 52).  Individual fresh-cut produce companies 
began product testing in response to the 2006 E. coli  O157:H7 outbreak associated with bagged 
fresh spinach (Ref. 53). At least one company is reported to  use product testing to verify the 
efficacy of good agricultural practices programs a nd to prevent contaminated product lots from 
entering commerce (Ref. 52).  The California Leafy Greens Ma rketing Agreement requires crop 
testing for E. coli  O157:H7 and Salmonella spp. whenever a crop has been directly contacted 
with water that exceeds th e agreements’ acceptance cr iteria for generic E. coli  (Ref. 31).  
Product testing, especially micr obiological testing, for proces s control purposes presents 
several challenges.  Pathogen prevalence in prod uce as a result of contamination events that 
occur during growing, harvesting, packing, or holding on farms are generally temporally 
intermittent, non-homogeneous in a lot or a field, and at low concentrations (Ref. 54).  Therefore, 
unlike some processed foods that may consist of  batches of homogeneous material (e.g., bulk 
flour, milk, juice), produce are best  thought of as individual units, and while a positi ve test result 
for one unit does raise concern about the rest of the lot or the fiel d subject to the same conditions, 
procedures, processes, and practices, any cont amination present in one unit may not have 
necessarily spread to other units.  In addition, it is generally recognized th at negative product test 
results do not necessarily indicate the absence of a hazard, particularly when the hazard is 
present at very low levels a nd is not uniformly distributed (Ref. 55.Ref. 56).  Sampling plans 
intended to ensure detection of contamination w ith a reasonable assura nce of success in produce 
lots or fields can be cost-prohibitive, and may not  be effective for use in produce.  For example, 
for any given contamination rate, th e probability of detecting Salmonella  increases with the 118 
 
number of samples tested and it is not feasible to identify low levels of contamination in an 
individual lot.  For example, when 30 samples in  a lot are tested, the probability of detecting 
Salmonella  is 1 percent when the contamination rate is 1 in 3000, 26 percent when the 
contamination rate is 1 in 100, and 96 percen t when the contamination rate is 1 in 10 (Ref. 57).  
Both industry and FDA survey data indicate that  contamination rates in produce (melons, greens, 
tomatoes), while variable, are typically very low (Ref. 58.Ref. 59).  In addition, microbial testing 
can only detect the pathogens that the analytical  procedures are designed to detect.  Testing 
instead for indicator organisms may be a viable option, but is  not without challenges, as 
discussed in section V.E.2. of this document.   
Another factor affecting the ut ility of product testing for pa thogens as a control measure 
is that FDA recommends, and it is generally indust ry practice, to hold any batch of product from 
which samples are taken for testing to prevent the need for a recall s hould the test results 
demonstrate the presence of a pathogen.  With a hi ghly perishable product as is the case for most 
produce, storing product during such analyses woul d significantly reduce the shelf-life of the 
product.  For these reasons, we tentatively conclu de that product testing would be impracticable 
as a component of science-based minimum standard s proposed in this rule except as set forth in 
proposed subpart M under certain ci rcumstances for sprouts.    
 J.  Effective Dates We are proposing that the effective date of th is rule would be 60 da ys after the date of 
publication of the final rule in the Federal Register
 with staggered compliance dates.  The 
effective date is the date that provisions in  the rule affect the current CFR.     119 
 
An effective date of 60 days after date of publication of the final rule in the Federal 
Register  would be consistent with the effective dates in recent FDA rules directed to food safety.  
See, e.g., Federal Register  of July 9, 2009 (74 FR 33029 at 33030) , establishing an effective date 
of September 8, 2009, for a final rule for the prev ention of Salmonella Enteritidis in shell eggs 
during production, storage, and tran sportation; and Federal Register  of June 25, 2007 (72 FR 
34751 at 34752), establishing an effective date of August 24, 2007, for a final rule for current 
good manufacturing practice in ma nufacturing, packaging, labeling, or holding operations for 
dietary supplements. 
 K. Compliance Dates We are proposing that the compliance dates for entities subject to the rule would be based 
on the size of a farm and the effective date of the requirement, with additional flexibility for 
compliance with proposed provisions for water qu ality in § 112.44 and related provisions in §§ 
112.45 and 112.50 (specifically, 112.50(b)(5),  112.50(b)(6), and 112.50(b)(7)).   
The compliance date for very small businesse s (those subject to proposed part 112 and, 
on a rolling basis, the average a nnual monetary value of food sold  during the previous three-year 
period is no more than $250,000, as defined in pr oposed § 112.3(b)(1)) would be four years from 
the effective date (with the exception of compliance with §§ 112.44, 112.45, 112.50(b)(5), 
112.50(b)(6), and 112.50(b)(7), as discussed belo w).  The compliance date for very small 
businesses would not be in conf lict with the requirement in s ection 419(b)(3)(B) of the FD&C 
Act for the regulations promulgated under section 419 to apply to very small businesses “after 
the date that is 2 years after th e effective date of the final regu lation….” because this requirement 
specifies that the regulations sha ll apply after, not on, th e date that is 2 year s after the effective 120 
 
date.  To provide additional flexibility to small businesses, we would provide two more years for 
very small businesses to comply  with the rule than is requ ired under sectio n 419(b)(3)(B).  
Providing an extended compliance period to very  small businesses as a means of providing 
additional flexibility is consistent with our approach to compliance dates in recent rules directed to food safety.  (See, e.g., 74 FR  33029 at 33034 and 72 FR 34751 at 34752.) 
The compliance date for small businesses (thos e subject to proposed part 112 and, on a 
rolling basis, the average annual monetary valu e of food sold during th e previous three-year 
period is no more than $500,000, as defined in  proposed § 112.3(b)(2)) would be three years 
from the effective date (w ith the exception of complia nce with §§ 112.44, 112.45, 112.50(b)(5), 
112.50(b)(6), and 112.50(b)(7), as discussed below) .  The compliance date for small businesses 
would not be in conflict with th e requirement in section 419(b)(3 )(A) of the FD&C Act for the 
regulations promulgated under section 419 to apply to  small businesses “after  the date that is 1 
year after the effective date of the final regulati on….” because this requirement specifies that the 
regulations shall apply after, not on, the date that is 1 year after the effective date.  To provide 
additional flexibility to small businesses, we would provide two more years than is required 
under section 419(b)(3)(A).  Provi ding an extended compliance pe riod to small businesses as a 
means of providing additional flexib ility is consistent with our approach to compliance dates in 
recent rules directed to food safety.  (S ee, e.g., 74 FR 33029 at 33034 and 72 FR 34751 at 
34752.) 
The compliance date for all other farms subject  to the rule would be two years from the 
effective date (with the exception of  compliance with §§ 112.44, 112.45, 112.50(b)(5), 
112.50(b)(6), and 112.50(b)(7), as discussed below).   121 
 
The compliance dates for water quality requirements in proposed § 112.44 and related 
provisions in §§ 112.45, 112.50(b)(5), 112.50(b)(6),  and 112.50(b)(7) would be two years 
beyond the compliance date for the rest of the final rule applicable to the farm based on its size.  
We recognize that farms may need additional ti me to cope with implementation of the water 
quality testing, monitoring, and related record-k eeping provisions.  This additional compliance 
period would also be expected to permit farms to consider identifying alternatives to the standard 
in proposed § 112.44(b) and developi ng adequate scientific data or information necessary to 
support a conclusion that the altern ative would provide the same le vel of public health protection 
as the standard that would be established in th is part, and would not in crease the likelihood that 
the covered produce will be adulterated under sec tion 402 of the FD&C Act, in light of the 
farm’s covered produce, practices , and conditions.  The extended compliance dates for the water 
quality testing, monitoring, and related reco rd keeping requirements in proposed §§ 112.44, 
112.45, 112.50(b)(5), 112.50(b)(6), and 112.50(b)(7) would then be six years from the effective 
date for very small businesses, five years from the effective date for small businesses, and four 
years from the effective date for all other farms subject to the rule. 
The compliance dates would apply to all farms subject to the rule, including those farms 
that satisfy the requirements in proposed § 112.5 fo r an exemption from mo st requirements of the 
rule, because such farms have modified require ments (proposed § 112.6) to which they would be 
subject on the relevant compliance date. 
We seek comment on these proposed implemen tation periods.  In addition, given that 
activities related to produce pr oduction, harvesting, packing, and hol ding may be affected by the 
produce growing season, we seek comment on whether these compliance dates sufficiently 
address any issues related the seasonal  nature of produce-related activities. 122 
 
 
V.  The Proposal   
A. Subpart A – General Provisions 
As proposed, subpart A contains pr ovisions that establish the scope  of, and definitions applicable 
to, this regulation, and identifies wh o is subject to the requirements  of this part.  This subpart 
also describes the proposed modified requi rements and procedures governing qualified 
exemptions from this rule. 
1. Comments Related to  Proposed Provisions 
We received several comments in response to th e 2010 FR notice that addressed issues relevant 
to the general scope of this proposed rule. Some  comments requested that tree crops be exempt 
from this regulation.  For example, an apple grower  asserted that apples ar e not as susceptible to 
E. coli  and other pathogens as are le ttuce and tomatoes, and therefor e they should not be subject 
to the same controls and restric tions.  Additionally, one grower stat ed that citrus fruits should be 
exempt because citrus fruits have not been iden tified to be the source of an incident of food-
borne illness, a majority of such produce doe s not touch the ground, citrus fruit are washed 
during the packing process, and the peel is rarely consumed raw.  Several comments from 
produce associations requested removal of waterm elons from the “melon” category, stating that 
they should have their own categor y since they have a different ri sk profile from other melons.  
In addition, comments from several tree nut grow ers stated that some  tree nut commodities 
should have less rigorous requi rements or be exempt.  
As we explained in Section IV.C, we tentatively concluded that an approach that considers both 
the risk associated with the commodity and that associated with the agricultural practices applied 
to the crop under the conditions in which it is grown, would provide the most appropriate 123 
 
balance between public health protection, flexibi lity, and appropriate management of different 
levels of risk.  Under this approach, we c onsidered available information on outbreaks and 
contamination as well as existing evidence on char acteristics of the commodity (such as whether 
the commodity grows on trees or has a smooth rind).  This evidence informed the proposed 
requirements, but we have tentatively conclude d that limiting the scope of this rule based on 
outbreak data or on the levels of frequency of  pathogen detection alone would not adequately 
address the risk of serious adverse health conseq uences or death.  Therefore, as discussed in 
section V.A.2.a. of this document, we are proposi ng to cover apples, citrus fruits, watermelons, 
and tree nuts in this proposed rule.  Becau se the scope and stringency of the regulatory 
requirements depends in several cases on the ty pes of practices employed within operations, 
producers of different commodities who use differen t practices will not be subject to all of the 
same controls and restrictions. We seek co mment on our proposed approach. Because our 
regulatory approach does not depend on categoriz ing commodities based on risk profiles, we do 
not see the need to distinguish among fruits, including watermelons, on this basis.  We do note, 
however, that in proposed § 112.1(b)(1) we have  listed watermelons separately from other 
melons.  While we propose to cover tree nuts that  do not meet the criteria we propose for “rarely 
consumed raw” (see section V.A.2.a) in this pr oposed rule, such as wa lnuts and almonds, we 
recognize that many of these tr ee nuts receive commercial pro cessing to adequately reduce 
pathogens and, thus, may be eligible for an exemption under proposed § 112.2(b) (discussed in 
section V.A.2.a. of this document).  Our main fo od safety concerns relevant to on-farm growing, 
harvesting, packing, and holding of tr ee nuts pertain to those tree nuts  that would be sold raw and 
untreated.  We request  comments on our treatment of tree nuts in this proposal.  124 
 
We also received comments regarding various ac tivities performed on produce in relation to the 
scope of this proposed rule. One comment stated  that “processing” shoul d not refer to rinsing 
heads of lettuce or bunches of greens before they  are packed for market , but rather should be 
defined specifically to include other processes that appear to involve additional risk to the 
consumer.  Some comments suggest ed that no grower should be exempt from these food safety 
regulations, whereas another stakeholder stated th at the produce safety standards must be very 
clear as to what constitutes produce processing ve rsus produce preparation for market acceptance 
and that Part 110 should be reserved for s ituations where extensive commingling, cutting, 
washing and bagging of produce are practiced.  Fi nally, a comment suggest ed that growers who 
deliver produce to the consumer within 24-30 hou rs should be exempt from this regulation.   
As discussed in section III.F. of this document and further in section V.A.2.b.i below, this 
proposed rule would apply to activities of farms and farm mixed-type fac ilities that are within 
the definition of “farm” proposed he re.  A farm or farm mixed-type  facility that washes its own 
covered produce would be harvestin g within the farm definition and therefore that activity would 
be covered by this proposed rule unless another exemption applied.  However, a farm mixed-type 
facility that washes covered produce not grown on that farm or another farm under the same 
ownership for distribution into commerce would be  engaging in an activity outside the farm 
definition (i.e., a manufacturing/proc essing activity).  Such activities would not be subject to this 
rule but instead would be subject to  section 418 of the FD&C Act..   
As discussed in section I of th is document and the QAR, produce is  vulnerable to contamination 
by pathogens, which can occur at various poi nts during growing, harvesting, packing, and 
holding.  Although contamination usually occurs in low doses, even low doses of some of these 
harmful pathogens can result in human illness or death (Ref. 60).  Thus, if produce is 125 
 
contaminated with a pathogen, there is a reasona ble possibility that the amount of the pathogen 
present will be enough to cause serious adverse hea lth consequences or death to a consumer even 
without an extended time period before consump tion for the pathogen to grow and multiply.  In 
addition, even in cases where the delivery time may not exceed 24-30 hours, consumers and other recipients may store produce (in a refrigerator or otherwise)  thereafter and not consume it 
immediately, allowing additional time for pat hogen growth.  Therefor e, FDA tentatively 
concludes it would not be appropriate to exempt any farms from this proposed rule based on the 
speed of their deliveries to the consumer.   
2. Proposed Requirements a. Food Covered By This Rule 
This proposal is applicable to certain farm activities performed on certain produce for use as 
human food.  Section 105 of  FSMA does not specify whether the rulemaking conducted under 
that section should apply to human food, an imal food, or both.  The general rulemaking 
requirements in 419(a)(1)(A), (b)(1 ), and (c)(1)(A) authorize FDA to establish standards for the 
safe production and harvesting of fruits and vegeta bles that are raw agricultural commodities for 
which the Secretary has determined that such standards minimize the risk of serious adverse 
health consequences or death.  F DA tentatively concludes that the risk posed to animals, and to 
humans from contact with animals or consump tion of animals as food, by farm practices in 
producing and harvesting fruits and vegetables  does not merit imposition of new regulatory 
requirements at this time.  Therefore, this pr oposal is limited to produce for use as human food. 
Produce that is intended for use as animal food w ould not be subject to th e requirements of this 
rule.  This is reflected in th e title of the proposed rule (“St andards for the Growing, Harvesting, 
Packing, and Holding of Produce for Human Co nsumption”) and its proposed location in 126 
 
Chapter I, Subchapter B of Title 21, Code  of Federal Regulations (“Food for Human 
Consumption”). As proposed, § 112.1 establishes the scope of food th at is subject to this rule.  Under proposed § 
112.1(a), food that meets the definition of produce in § 112.3(c) and that is a raw agricultural 
commodity (RAC) as defined in section 201(r) of  the FD&C act, would be covered by part 112, 
unless it is excluded by § 112.2.  Section 201(r) de fines “raw agricultural commodity” as any 
food in its raw or natural state, including all fruits that are washe d, colored, or otherwise treated 
in their unpeeled natural form  prior to marketing.”  This includes produce RACs grown 
domestically and produce RACs th at will be imported or offere d for import in any State or 
territory of the United States, th e District of Columbia, or the Commonwealth of Puerto Rico.  
As discussed in section III and IV  of this document, FDA tentatively concludes that proposed § 
112.1(a) is consistent with section 419(a)(1)(A) of  the FD&C Act, which di rects us to establish 
science-based minimum standards fo r the safe production and harvesting of those types of fruits 
and vegetables that are raw agricultural commodities for which the Secretary has determined that 
such standards minimize the risk of serious adverse health consequences or death.   
We propose to establish a defini tion of “produce” in proposed § 112.3(c) (see section V.A.2.b.iii. 
of this document) that would be relevant to th e use of that term in proposed § 112.1.  “Produce” 
would mean any fruit or vegeta ble (including specific mixes or categories of fruits and 
vegetables) grown for human cons umption, and would include mush rooms, sprouts (irrespective 
of seed source), peanuts, tree nu ts and herbs.  Within the de finition of “produce,” we would 
further define “fruit” and “vegetable” to re flect the common meanings of those terms. 
We would define a fruit as the edible reproductive body of a seed plant or tr ee nut (such as apple, 
orange and almond), such that fruit would mean the harvestable or harvested part of a plant 127 
 
developed from a flower.  This is consistent w ith the common meaning of the term “fruit,” as 
demonstrated by the Merriam-Webster Dictionary de finition of “fruit” to m ean, in relevant part 
“the usually edible reproductiv e body of a seed plant; especi ally : one having a sweet pulp 
associated with the seed … a succulent plant part (as the petioles of a rhubarb plant) used chiefly 
in a dessert or sweet course ... a product of fertilization in a plan t with its modified envelopes or 
appendages; specifically: the ripened ovary  of a seed plant and its contents...” (Ref. 61).  
We would define a vegetable as the edible part  of an herbaceous plan t (such as cabbage and 
potato) or fleshy fruiting body of  a fungus (such as white button and shiitake) grown for an 
edible part, such that vegetable would mean the harvestable or harvested part of any plant or 
fungus whose fruit, fleshy fruiting bodies, seeds, roots, tubers, bulbs, stems, leaves, or flower 
parts are used as food and includes mushrooms, spr outs, and herbs (such as basil and cilantro).  
This is consistent with the co mmon meaning of the term “vegetable,” as demonstrated by the 
Merriam-Webster Dictionary defi nition of “vegetable” to mean, in relevant part, “a usually 
herbaceous plant (as the cabbage, bean, or potato) gr own for an edible part that is usually eaten 
as part of a meal; also : such an edible part…” (Ref. 61).   
We are proposing to specify in the definition of produce that it include s mushrooms, sprouts, 
peanuts, tree nuts and herbs, to leave no doubt about the status of these foods. 
Taxonomically, a mushroom is a fungus (Ref. 62).  For regulatory purposes in the United States, 
however, mushrooms have generally  been treated as vegetables.  Mushrooms are classified as 
vegetables by USDA AMS under the Perishable Agricultural Commodities Act (7 U.S.C. 499a-
499t) (PACA) (Ref. 63), using a definition stating in relevant  part that “fresh fruits and fresh 
vegetables” means “all produce in fresh form gene rally considered as perishable fruits and 
vegetables…” (21 CFR § 46.2(u)).  The USDA 2010 Dietary Guidelines for Americans also 128 
 
include mushrooms in the “vegetable” food group (Ref. 64).  In addition, the produce industry 
appears to recognize mushrooms as vegetables, as demonstrated by various industry documents 
(Ref. 65.Ref. 66).  Moreover, the hazards and controls relevant to minimizing serious adverse 
health consequences or death during the growing, harvesting, p acking, and holding of 
mushrooms are generally similar to those for other produce (Ref. 67).  Accordingly, we 
tentatively conclude that it is reasonable to include mushrooms in the proposed definition of 
“vegetable.” Sprouts meet the definition of “vegetable” above from the Merriam-Webster Dictionary 
(Ref. 
61).  In addition, sprouts ar e classified as vegetabl es by USDA AMS under PACA (Ref. 63).  The 
USDA 2010 Dietary Guidelines for Americans also  include “bean sprouts” in the “vegetable” 
food group (Ref. 64).  In addition, the produce industry appears to recogn ize sprouts as 
vegetables, as demonstrated by various industry documents (Ref. 68).  Moreover, the hazards and 
controls relevant to minimizing serious adve rse health consequences  or death during the 
growing, harvesting, packing, and holding of spro uts are generally similar to those for other 
produce, but with additional cont rols necessary due to the uni que risks presented by sprouts (Ref. 
160.Ref. 161) (see section V.M of this document).  Accord ingly, we tentatively conclude that it is 
reasonable to include sprouts in the proposed definition of “vegetable.” 
Herbs meet the definition of “vegetable” above from the Merriam-Webster Dictionary (Ref. 61).  
Herbs are generally consumed in combination with  other foods (for example, in salads or as 
garnishes) rather than consumed as distinct se rvings, but they nonetheles s satisfy the dictionary 
definition of “vegetable.”  In addition, USDA considers herbs to be covered commodities under PACA, such that they are classified as “herbs ” but fall within the broader category of “fresh 
fruits and fresh vegetables” 
(Ref. 63).  In addition, the produce i ndustry appears to recognize 129 
 
herbs as vegetables, as demonstr ated by various industry documents (Ref. 66).  Moreover, the 
hazards and controls relevant to minimizing seri ous adverse health consequences or death during 
the growing, harvesting, packing, and holding of he rbs are generally similar to those for other 
produce(Ref. 13.Ref. 50).  Accordingly, we tentatively conclu de that it is reas onable to include 
herbs in the proposed definition of “vegetable.” Peanuts and tree nuts both meet the definition of “fruit” above from  the Merriam-Webster 
Dictionary 
(Ref. 61).  The Merriam-Webster Dictionary define s “peanut,” in rele vant part, as “a 
low-branching widely cultivated annual herb … of the legume family with showy yellow flowers having a peduncle which elongates and bends into  the soil where the ovary ripens into a pod 
containing one to three oily edible seeds…,” and “nut,” in relevant part , as “a hard-shelled dry 
fruit or seed with a separable ri nd or shell and interior kernel…” 
(Ref. 61).  In addition, the 
produce industry appears to recognize peanuts and tree nuts as produce, as demonstrated by 
various industry documents (Ref. 65.Ref. 66).  Moreover, the hazards a nd controls relevant to 
minimizing serious adverse health consequen ces or death during the growing, harvesting, 
packing, and holding of peanuts and tree nuts ar e generally similar to those for other produce 
(Ref. 69.Ref. 70).  Specifically, peanuts and tree nuts share the significant hazard of pathogens 
with other covered produce.  To a significan t extent, this hazard is eliminated during 
manufacturing/processing operations, such as ro asting, by facilities subject  to section 418 of the 
FD&C Act, rather than through measures taken by farms subject to this re gulation.  However, as 
discussed in section V.A.2.a below, peanuts m eet our proposed criteria for “rarely consumed 
raw” and therefore would be exempt from this  proposed rule.  Tree nuts that do not meet the 
criteria for “rarely consumed ra w” would also be exempt from  this proposed regulation if you 
establish and keep documentation that demonstrat es that the recipient of the produce performs 130 
 
commercial processing in accordance with propo sed § 112.2(b)(1).  For tree nuts that remain 
subject to the proposed rule, the kinds of measur es necessary to minimize the risk of known or 
reasonably foreseeable biological hazards are the same as those in subparts A through O of this 
proposed rule (e.g., control of soil amendmen ts, agricultural wate r, worker hygiene). 
Accordingly, we conclude it is reasonable to  include peanuts and tr ee nuts in the proposed 
definition of produce as a “fruit.”  We recogni ze that peanuts and tree nuts are not covered 
commodities under PACA ((Ref. 63.Ref. 71) and that the USDA 2010 Dietary Guidelines for 
Americans consider nuts a “protein  food” rather than as part of  the “fruits and vegetables” group 
for the purpose of providing dietary advice (Ref. 72); however, in light of the treatment of 
peanuts and tree nuts as pr oduce in common usage and in the produce industry, and the 
commonality of on-farm hazards and controls for peanuts, tree nuts, and other produce (Ref. 
70.Ref. 69), we tentatively conclude that  it is reasonable to include p eanuts and tree nuts in the 
proposed definition of produce as “fruits.” 
We propose to specify in the definition of “produ ce” that the term would 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 would in clude barley, dent- or flint-corn, sorghum, oats, 
rice, rye, wheat, amaranth, quinoa, buckwheat , cotton seed, and soybean.  Our proposed 
definition of “food grains” is consistent with the common meaning of the term “grain” when 
used in the context of food, as demonstrated by the Merriam-Webster Dictionary definition of 
“grain” to mean, in relevant part, “a seed or fruit of a cereal grass … the seeds or fruits of various 
food plants including the cereal grasses and in co mmercial and statutory usage other plants (as 131 
 
the soybean) … plants producing grain…” (Ref. 61).  In addition, the industry appears to 
recognize grains as a separate commodity gr oup from produce, as demonstrated by various 
industry documents regarding “produce” and “fruits  and vegetables” that do not include grains 
(Ref. 65.Ref. 66).  Grains are not covered commodities under PACA (Ref. 63).  The USDA 2010 
Dietary Guidelines for Americans treat grains  as a separate food group from the “fruits and 
vegetables” food group (Ref. 73).  In addition, the hazards and c ontrols relevant to minimizing 
serious adverse health consequences or deat h during the growing, harvesting, packing, and 
holding of grains are significan tly different from those releva nt to fruits and vegetables (Ref. 74). 
Specifically, the hazards of concern in grains are primarily chemical hazards such as mycotoxins 
and pesticides, rather th an biological hazards (which, as di scussed in secti on IV.B. of this 
document, are the only hazards we currently propose to address in this rule, as they are the most 
significant hazards affecting covered produce), becau se grains are milled and/or cooked such that 
pathogens that may be present are reduced to a le vel where they are unlikel y to present a risk to 
public health for most products. Accordingly, we te ntatively conclude that  it is reasonable to 
exclude grains from the definition of “produce.” Proposed § 112.1(b)(1) lists specifi c examples of produce covered by this rule.  Such covered 
produce would include almonds, appl es, apricots, aprium, asian pear, avocados, babaco, bamboo 
shoots, bananas, Belgian endive, blackberries, blueberries, broccoli,  cabbage, cantaloupe, 
carambola, carrots, cauliflower, celery, cherries, c itrus (such as clementine, grapefruit, lemons, 
limes, mandarin, oranges, tangerines, tangors, an d uniq fruit), cucumbers, curly endive, garlic, 
grapes, green beans, guava, herbs (such as basil,  chives, cilantro, mint, oregano, and parsley), 
honeydew, kiwifruit, lettuce, mangos, other melons  (such as canary, crenshaw and persian), 
mushrooms, nectarine, onions, papaya, passion fruit,  peaches, pears, peas, peppers (such as bell 132 
 
and hot), pineapple, plums, plumcot, radish,  raspberries, red currant, scallions, snow peas, 
spinach, sprouts (such as alfalfa and mung bean),  strawberries, summer squash (such as patty 
pan, yellow and zucchini), tomatoes, wa lnuts, watercress and watermelon.   
  The list of fruits and vegetables provided in pr oposed § 112.1(b)(1) is not an exhaustive list of 
produce covered by this rule.  This section is intended simply to provide examples of produce 
commonly consumed in the United States that w ould be included within the scope of this 
regulation.  The absence of a specific fruit or vege table from this list doe s not indicate that it is 
not covered, except where the specific fruit or vegetable is exempted from the regulation by § 
112.2(a)(1).  We request comment on the examples of  fruits and vegetables listed in 112.1(b)(1).  
Proposed § 112.1(b)(2) would clarify that mixes of intact fruits and vegetables (such as fruit 
baskets) are also covered by this rule.  Pr oposed § 112.1(b)(2) is consistent with section 
419(a)(1)(A) of the FD&C Act, which includes mixe s or categories of fruits and vegetable RACs 
as part of the rulemaking requirement we are implementing through this proposed rule.  
As proposed, § 112.2(a) identifies three types of  produce not covered by this rule.  First, 
proposed § 112.2(a)(1) provides an exclusion for produce that is rarely consumed raw.  FDA 
proposes to establish the following exhaustive list of specific fruits  and vegetables that would be 
exempt under this provision: arrowhead, arrowroot, artichokes, as paragus, beets, black-eyed 
peas, bok choy, brussels sprouts, chick-peas, collard gr eens, crabapples, cranberries, eggplant, 
figs, ginger root, kale, kidney bean s, lentils, lima beans, okra, pa rsnips, peanuts, pinto beans, 
plantains, potatoes, pumpkin, rhubarb, rutabaga, sugarbeet, sweet corn, sweet potatoes, taro, 
turnips, water chestnuts, winter squash (acorn and butternut squash), a nd yams.  Because these 
listed fruits and vegetables are almost always consumed only afte r being cooked, which is a kill-133 
 
step that adequately reduces the presence of microorganisms of public health significance, we 
propose that these listed produce be excluded from the requirements of this rule.  Studies have 
shown that the numbers of microorganisms of public health significan ce (such as Listeria 
monocytogenes,  Salmonella , shiga toxin-producing E. coli ) are significantly reduced in produce 
by a variety of relatively moderate heat treatments (Ref. 75.Ref. 76.Ref. 77.Ref. 78).  Therefore, 
we tentatively conclude that th e cooking that the produce listed in § 112.2(a)(1) receive before 
they are consumed, whether commercially or by the consumer, would be sufficient to minimize 
the risk of serious adverse health consequences or death.   We note that all produce commodities are and will continue to be covered under the adulteration 
provisions and other app licable provisions of the Federa l Food, Drug, and Cosmetic Act and 
applicable implementing regulations, irrespective of whether they are included within the scope of this proposed rule.   We developed this list in proposed § 112.2(a)(1) of produce that rarely is consumed raw by 
analyzing consumption data on selected produce commodities using data available from the 
National Health and Nutrition Examinati on Survey (NHANES) and other resources 
(Ref. 79).  
We looked at the percentage of  the population consuming the pr oduce commodity in fresh form 
as well as the percenta ge of eating occasions on which th e produce commodity is eaten uncooked 
(Ref. 79.Ref. 80).  As explained further in a memo to  the record, we f ound that artichokes, 
asparagus, beets, bok choy, brussels sprouts, cran berries, eggplant, figs, ginger root, lima beans, 
okra,  plantains, potatoes, rhubarb, sweet cor n, sweet potatoes, turnips, and yams are eaten 
uncooked by less than 0.1% of the U.S. popula tion and are consumed uncooked on less than 
0.1% of eating occasions  (Ref. 79).  Other commodities, including black-eyed peas, chick-peas, 
collard greens, crabapples, kale, kidney beans, le ntils, parsnips, peanuts,  pinto beans, pumpkin, 134 
 
rutabaga, sugarbeet, taro, wate r chestnut, and winter squash (which includes both acorn and 
butternut squash) are included in the NHANES data set but their categories of reported 
consumption do not include “uncooked,” indicati ng that they are not consumed uncooked in any 
measurable quantity (Ref. 79).  Still other co mmodities on the list, namely, arrowhead and 
arrowroot, are not identified in th e NHANES data set as being eaten  in the United States in any 
form, uncooked or otherwise (Ref. 79).  Other re ferences indicated that those commodities are 
typically consumed cooked (Ref. 63.Ref. 82).  We request comment on the proposed criteria used 
for identifying the commodities that are rarely c onsumed raw.  Further, we request comment on 
additional commodities that should  be considered for inclusion in the list in 112.2(a)(1).  As 
noted above, we analyzed consumption data on se lected produce commodities to generate this 
list.  We acknowledge that there may be addition al commodities that would meet these criteria 
that we did not analyze.  Also, we anticipat e that, in the case of some commodities, the 
consumption rates in the United States may be  too low for the NHANES data and other data 
sources used in our analysis to support a conclu sion that the commodity is rarely consumed raw 
using our proposed criteria.  We request commen t on additional sources of information and/or 
criteria that should be ap plied in such cases.   
We also request comment on the inclusion of commodities that our analysis indicates are rarely consumed raw, but may not be prepared in a manner that would kill microbial contaminants, 
should they be present on the food.  For exam ple, we have included asparagus, bok choy, and 
cranberries in the list of commodities that will be  exempt from the requirements of this rule in 
proposed § 112.2(a)(1) because the NHANES data  indicated that these commodities are 
consumed uncooked by less than 0.1% of the U.S. population and are consumed uncooked on 
less than 0.1% of eating occasions 
(Ref. 79).  However, we are concerne d that the method of food 135 
 
preparation that these commodities may be subjected  (for example, stir frying bok choy) to prior 
to consumption may not constitute a kill-ste p that adequately reduces the presence of 
microorganisms of public health significance.  We request comme nt on our tentative conclusions 
about these commodities and others propos ed for exclusion in § 112.2(a)(1).   
Second, § 112.2(a)(2) proposes to exempt produce that  is produced by an i ndividual for personal 
consumption or produced for consumption on the farm or another farm under the same 
ownership.  With respect to the exemption fo r personal consumption, section 419(g) of the 
FD&C Act specifically exempts food produced by an individual for personal consumption from 
this rulemaking, and proposed § 112.2(a)(2) implem ents this exclusion.  With respect to the 
exclusion for produce for consumption on the farm  or another farm under the same ownership, 
such activities are within the de finition of farm that we propos e here, and would therefore be 
subject to this rule without an exemption.  To the extent that there is  any difference between 
produce “for personal consumption” and produce “consumed on the farm or another farm under 
the same ownership,” FDA proposes to exclude produ ce for either type of consumption from this 
proposed rule.  Third, § 112.2(a)(3) proposes to exclude produce th at is not a raw agricultural commodity from 
this proposed rule.  For example, this would ex clude “fresh-cut” produce,  which is subject to 
current part 110 and to section 418 of the FD&C Act as applicable 
(Ref. 83).  This is consistent 
with section 419(a)(1)(A) of the FD&C Act, which directs FDA to “establish science-based 
minimum standards for the safe production a nd harvesting of those types of fruits and 
vegetables… that are raw agricultural commodities….”  This is also consistent with the application of this rule to ac tivities within the farm definitio n.  In section V.A.2.b.i of this 
document, we discuss how we considered how the activities of farms relate  to the concept of a 136 
 
RAC and tentatively concluded that the farm defi nition and related defin itions in this proposed 
rule should be revised based on the concept that  RACs are the essential products of farms.  
Accordingly, the definitions proposed here (for the terms farm, mixed-type facility, harvesting, 
manufacturing/processing, packi ng, and holding) reflect the tentat ive conclusion that activities 
involving RACs that farms traditionally do fo r the purposes of growing their own RACs, 
removing them from the growing areas and prep aring them for use as a food RAC, and for 
packing, holding and transporting them, should all be wi thin the definition of “farm.”  This is the 
case even if the same activities off-farm would be considered to  be “manufacturing/processing” 
because those activities involve “making food from one or more ingredients, or synthesizing, 
preparing, treating, modifying or manipulating f ood.”  This special classification of on-farm 
activities, however, should only apply to RACs because only RACs, not processed foods, are the 
essential products of farms.  For all of these reasons, RACs ar e a logical and appropriate focus 
for these produce safety standards. 
In addition to these three exemptions men tioned above, under the conditions specified in 
§ 112.2(b), we propose to allow covered produce wh ich receives commercial processing that 
adequately reduces the presence of microorganisms of public health  significance to be eligible 
for an exemption from the requirements of this pa rt (except for subparts A, Q, and O).  Examples 
of commercial processing that adequately re duces the presence of microorganisms of public 
health significance are processing in accordance w ith the requirements of part 113, part 114, or 
part 120; treating with a validat ed process to eliminate spore- forming microorganisms (such as 
processing to produce tomato paste or shelf-stable  tomatoes); and processing such as refining or 
distilling produce into products such as sugar, oil, spirits, or similar products.  As discussed in 
section IV.C. of this document,  FDA tentatively concludes th at such commercial processing 137 
 
significantly minimizes the risk of  serious adverse health conseque nces or death associated with 
biological hazards for such produce, such that th e produce can be considered to be low risk and 
the imposition of the requirements in this propose d rule is not warranted.  We note that such 
produce is and will continue to be covered under the adulteration provisions and other applicable 
provisions of the Federal Food, Drug, and Co smetic Act and applicable implementing 
regulations, irrespective of whet her it is included within the scope of this proposed rule. 
As proposed, to qualify for the § 112.2(b) exemption, proposed § 112.2(b)(2) would 
require you to establish and keep documentation of the identity of  the recipient of the covered 
produce that performs the commercial proce ssing in accordance with the requirements of 
proposed subpart O.  FDA tentatively concludes th at such records are necessary for the efficient 
enforcement of the FD&C Act.  Without such  records, FDA would have no way to assess 
whether farms are complying with the terms of this exemption.  In addition, proposed § 
112.2(b)(3) would clarify that th e requirements of subparts A and Q apply to such produce 
because subpart A includes relevant provisions such  as the scope of this rule and definitions, and 
Q contains provisions relating to co mpliance and enforcement.     
It is important to note that any of the ex emptions in proposed § 112.2 are only applicable 
to the produce specified in the ex emption.  In other words, a covered farm may not rely on these 
exemptions for all of its covered produce simply  because a subset of that produce is rarely 
consumed raw; is for personal or on-farm cons umption; is not a RAC; or will receive the 
requisite commercial processing; in those instan ces, only the subset that meets the relevant 
exemption criteria would be exempt from this pr oposed rule.  For example, if you own or operate 
a farm that produces both tomatoes that will be processed into tomato paste, and tomatoes that 
will not receive any commercial processing to  adequately reduce pathogens, and you do not 138 
 
qualify for any other exemption, you would be subject  to the rule when you grow, harvest, pack 
or hold those tomatoes that will  not be processed to adequately  reduce pathogens.  Likewise, if 
you produce both artichokes and lettuce, you would be subject to the rule when you grow, 
harvest, pack or hold lettuce, but you would not be subject to the rule when you grow, harvest, 
pack, or hold artichokes.  We request comment on proposed §§ 112.1 and 112.2, including the specific examples of 
produce that would be covered by the rule; the list of  produce that would not be covered by the 
rule because it is rare ly consumed raw; and the proposed exemption for produce that receives 
commercial processing, including the types of processing that should qualify for this exemption.   
b. Definitions 
Proposed § 112.3 would establish the definitions of terms for purposes  of part 112.  To the extent 
possible, the new definitions proposed in § 112.3 are consistent with th e common meanings of 
these terms as well as the defini tions of the terms in other f ood safety regulations (see, e.g., 
current § 110.3 and § 111.3) and other applicable sources.  As proposed in § 112.3(a), to provide 
clarity and consistency, the definitions and interp retations of terms in section 201 of the FD&C 
Act will apply to such terms when used in part 112.    i. Definitions of “Farm,” “Mixed-type facility,” and Related Activities  
We are proposing to establish an inter-related series of definitions in this proposed rule 
that, collectively, would address se veral issues related to the sc ope of establishments (namely, 
“farms”) that would be subject to the rule.  Thes e inter-related definitions include two definitions 
for types of establishments (i.e., “farm” and “mix ed-type facility”) and fi ve definitions for types 139 
 
of activities (i.e., “h arvesting,” “holding,” “manufactur ing/processing,” “packaging,” and 
“packing”) conducted on farms and mixed-type facilities.    
These proposed definitions are based on definitions already established in our regulations 
(e.g., in § 1.227 in the regulations for Registratio n of Food Facilities, established under section 
415 of the FD&C Act; hereinafte r the section 415 re gistration regulations).  However, the 
definitions that we are proposing for the purpose of the produce safety rule have some differences relative to the current definitions  established in the s ection 415 registration 
regulations.  In the near future, we plan to addr ess how we will coordinate the definitions in the 
section 415 registration regulations  with the definitions we are proposing for the purpose of the 
produce safety proposed rule.   
In developing these proposed definitions, we considered how the activities of farms relate 
to the statutory concepts of “raw agricultural commodity” and “processed food.”  The FD&C Act 
defines “raw agricultural commod ity” and “processed food” in relation to each other, and 
identifies certain activities that transform a raw agricultural commodity (RAC) into a processed 
food and others that do not.  Section 201(r) of the FD&C Act (21 U.S.C. 321(r)) defines “raw 
agricultural commodity” to mean “any food in its raw or natural state, including all fruits that are 
washed, colored, or otherwise treated in their unp eeled natural form prior to marketing.”  Section 
201(gg) of the FD&C Act (21 U.S.C. 321(gg)) defines “processed food” to mean “any food other than a raw agricultural commodity and includes any raw agricultural commodity that has been subject to processing, such as canning, cooking, freezing, dehydration, or milling.”  In addition, 
section 201(q)(1)(B)(i)(II) of th e FD&C Act (which defines pest icide chemicals) contains the 
following language regarding activit ies that do not transform a RAC into a processed food: “the 
treatment [with pesticide chemicals] is in a manner that does no t change the status  of the food as 140 
 
a raw agricultural commodity (including treat ment through washing, waxing, fumigating, and 
packing such commodities in such manner).” 
The status of a food as a RAC or processed food is relevant for many different purposes 
under the FD&C Act, including section 419(a)(1)(A) of the FD&C Act, which authorizes FDA to 
establish minimum science-based standards applicab le to certain fruits and vegetables that are 
RACs.  For example, under 403(w) of the FD&C Act (21 U.S.C. 343(w)), labeling requirements 
related to major food allergens apply to pro cessed foods but do not apply to RACs.  Under 
sections 201(q), 403(k), 403(l), and 408 of the FD &C Act (21 U.S.C. 32 1(q), 343(k), 343(l), and 
346a), the status of a food as a RAC has an im pact on the manner in which pesticide chemicals 
and their residues are regulated.  FSMA created more provisions in the FD&C Act and elsewhere 
that take status as a RAC or processed food into account, incl uding section 417(f) of the FD&C 
Act (21 U.S.C. 350f(f)), establis hing notification requirements fo r reportable foods that do not 
apply to fruits and vegetables that are RACs; s ection 418(m) of the FD&C Act, which authorizes 
FDA to exempt or modify the requirements fo r compliance under secti on 418 with respect to 
facilities that are solely engaged in the storage of  RACs other than fruits and vegetables intended 
for further distribution or processing; a nd section 204(d)(6)(D) of FSMA (21 U.S.C. 
2223(d)(6)(D)), which contains sp ecial provisions for commingled  RACs applicable to FDA’s 
authority under section 204 of FSMA to establish additional reco rdkeeping requirements for high 
risk foods.   
The term “raw agricultural commodity” and si milar terms also appear in other Federal 
statutes.  While these statutes are not implem ented or enforced by FDA and do not directly 
impact the interpretation of the definitions in se ctions 201(r) and 201(gg) of the FD&C Act, they 
do provide some suggestions about what “raw ag ricultural commodity” and related concepts can 141 
 
mean in various circumstances.  For example, the Secretary of Transportation may prescribe 
commercial motor vehicle safety standards under 49 U.S.C. 31136, but the Motor Carrier Safety 
Improvement Act of 1999 (Pub. L. 106-159, title II, Sec. 229, Dec. 9, 1999), as added and 
amended by the Safe, Accountable, Flexible, Effici ent Transportation Equity Act: A Legacy for 
Users (Pub. L. 109-59, title IV, Sec. 4115, 4130, Aug. 10, 2005), provided an exemption from 
maximum driving or on-duty times for drivers tr ansporting “agricultural commodities” or farm 
supplies within specific areas during planting and harvest peri ods.  In that circumstance, 
“agricultural commodity” is defined as “any ag ricultural commodity, non-processed food, feed, 
fiber, or livestock… and inse cts” (49 U.S.C. 31136 note).  Another example is 19 U.S.C. 
1677(4)(E), which provides for certain circumst ances in which producers or growers of raw 
agricultural products may be considered part of the industry producing processed foods made 
from the raw agricultural product for the purposes of customs duties and tariffs related to such 
processed foods.  In that circumstance, “raw ag ricultural product” is defined as “any farm or 
fishery product” (19 U.S.C. 1677(4)(E)).  These stat utes are informative in that they suggest that 
the “raw agricultural commodity” concept describe s and signifies the products of farms in their 
natural states, or, in other words, that whic h a farm exists to produce on a basic level.  
Because the status of a food as a RAC or processed food is of great importance in 
defining the jurisdiction of FD A and the U.S. Environmental Protection Agency (EPA) over 
antimicrobial substances, FDA and EPA have developed guidance regarding whether or not 
various activities transform RACs into processed foods.  FDA and EPA jointly issued a legal and 
policy interpretation of  the agencies’ jurisdiction under the FD&C Act over antimicrobial 
substances used in or on food (hereinafter th e “1998 Joint EPA/FDA Po licy Interpretation”) (63 
FR 54532, October 9, 1998).  In 1999, FDA issued guidance addressing several of the issues 142 
 
discussed in the 1998 Joint EPA/FDA Policy In terpretation.  (See Guidance for Industry: 
Antimicrobial Food Additives, July 1999 (hereinafter “Antimicrobial Guidance”) (Ref. 84)).  
Table 1 summarizes activities that cause food RA Cs to become processed foods and activities 
that do not change the status of a food RAC,  as set out in the 1998 Joint EPA/FDA Policy 
Interpretation and the Antimicrobial Guidance.  
Table 1. The Effect of Activit ies on RACs That Are Foods  
Activities That Change a RAC into a Processed Food Activities That Do Not Change the Status of a RAC 
Canning Application of pesticides (including by washing, 
waxing, fumigation, or packing) 
Chopping Coloring 
Cooking Drying for the purpose of storage or transportation 
Cutting Hydro-cooling 
Drying that creates a distinct commodity Otherwise treating fruits in their unpeeled natural form 
Freezing Packing 
Grinding Refrigeration 
Homogenization Removal of leaves, stems, and husks 
Irradiation Shelling of nuts 
Milling Washing 
Pasteurization Waxing 
Peeling Activities designed only to isolate or separate the 
commodity from foreign objects or other parts of the plant 
Slaughtering animals for food and activities done to 
carcasses post-slaughter, including skinning, 
eviscerating, and quartering  
Slicing  
Activities that alter the general state of the commodity  
 
In developing the proposed definitions, we also considered the definition of 
“manufacturing/processing” that FDA es tablished in § 1.227.  Under § 1.227(b)(6), 
“manufacturing/processing” means making food from one or more ingredients, or synthesizing, 
preparing, treating, modifying or manipulating food, including food crops  or ingredients. 
Examples of manufacturing/processing activ ities are cutting, peeling, trimming, washing, 
waxing, eviscerating, rendering, cooking, baki ng, freezing, cooling, pasteurizing, homogenizing, 
mixing, formulating, bottling, milling, grinding, ex tracting juice, dist illing, labeling, or 
packaging. The summary in Table 1 demonstrates th at the activities that transform a RAC into a 143 
 
processed food (and are sometimes therefore referre d to as “processing” in the context of a 
food’s status as a RAC or processed food) are not coextensive w ith the definition of 
“manufacturing/processing” that FDA established in § 1.227(b)(6) fo r the purposes of the section 
415 registration regulations.  The definition of “Manufacturing/processing” in that regulation 
includes most food-handling activitie s because it is satisfied by a ny degree of “making food from 
one or more ingredients, or synthesizing, preparing, treating, m odifying or manipulating food.”  
In contrast, transforming a RAC into a processed food seems to require meeting a threshold of 
altering the general state of  the commodity (Ref. 3, sect ion 7 and 63 FR 54532 at 54541), 
sometimes referred to as transformation of the RAC into a new or distinct commodity (61 FR 
2386 at 2388).  Because the activ ities that transform a RAC in to a processed food are not 
coextensive with the definition of “manufacturing/processing” in  § 1.227(b)(6), a given activity 
may be manufacturing/processing under the current definition in § 1.227(b)(6) without 
transforming a RAC into a processed food.  Ex amples of such activities include coloring, 
washing, and waxing.  
The current section 415 registra tion regulations demonstrate th at some activities may be 
classified differently on farms and off farms.  For example, “washing” is an example of 
manufacturing/processing under the definition of that term in § 1.227(b)(6).  However, 
“washing” produce is identified as part of harv esting under the farm definition in § 1.227(b)(3), 
so washing on farms is harvesting rather th an manufacturing/processing under the Section 415 
registration regulations.  To date , we have not articulated organi zing principles explaining these 
differences.   
In this document, we are tentatively articu lating five organizing pr inciples (summarized 
in Table 2 below) to explain the basis for the pr oposed definitions that would classify activities 144 
 
on-farm and off-farm for the purpose of this proposed  rule.  In the near future, we plan to address 
how we will coordinate the definitions in th e section 415 registration regulations with the 
definitions we are proposing for the purpose of this proposed rule.   
First Organizing Principle.  The statutes we describe above,  and previous interpretations 
of the concepts of RACs and processed food as set forth in the 1998 Joint EPA/FDA Policy 
Interpretation and the Antimicrobial Guidance, lead FDA to tentatively conclude that the basic purpose of farms is to produce RACs and that RACs  are the essential produc ts of farms.     
Second Organizing Principle.  
 Our second organizing principl e is that activities that 
involve RACs and that farms traditionally do for the purposes of gr owing their own RACs, 
removing them from the growing areas, and pr eparing them for use as a food RAC, and for 
packing, holding and transporting them, should all be within the definition of “farm.”  This is 
because the basic purpose of farms is to produce RACs  (principle 1).  This is the case even if the 
same activities off-farm would be considered to be manufacturing/pr ocessing, because those 
activities involve “making food from one or more ingredient s, or synthesizing, preparing, 
treating, modifying or manipulating food.”   
Third Organizing Principle .  Activities should be classified  based in part on whether the 
food operated on is a RAC or a processed food, and on whether the activity transforms a RAC 
into a processed food.  This is because principl e 2 (i.e., the special cl assification of on-farm 
activities) should only apply to RACs.  A farm that chooses to transform its RACs into processed 
foods should be considered to have chosen to expand its business beyond the traditional business 
of a farm.   
Fourth Organizing Principle.   Principle 2 (i.e., the speci al classification of on-farm 
activities) should only ap ply to RACs grown or raised on the farm itself or on other farms under 145 
 
the same ownership because the essential purpose of a farm is to produce its own RACs, not to 
handle RACs grown on unrelated farm s for distribution into commerce.   (For the purposes of this 
discussion, we refer to RACs gr own or raised on a farm or another farm under the same 
ownership as a farm’s “own RACs,” in cont rast to RACs grown on a farm under different 
ownership, which we refer to as “others’ RACs.” )  Activities that farms may perform on others’ 
RACs should appropriately be classified as manu facturing/processing, pack ing, or holding in the 
same manner as these activities are classified off-farm when the RA Cs are to be distributed into 
commerce.  In general, when a farm opts to pe rform activities outside the farm definition, the 
establishment’s activities that  are within the farm definition should be classified as 
manufacturing/processing, packi ng, or holding in the same manner as for a farm that does not 
perform activities outside the farm definition, but the activities that are outside the farm 
definition should be classified in the same manner as for an off-farm food establishment.  
Fifth Organizing Principle .  Manufacturing/processing, packing, or holding food-- 
whether RACs or processed foods, from any source  -- for consumption on the farm should 
remain within the farm definition because othe rwise farms could not feed people and animals on 
the farm without being considered to have e ngaged in activities outside the farm definition. 
 
Table 2. Summary of Organizing Pr inciples Regarding Classificat ion of Activities On-Farm and 
Off-Farm 
No. Organizing Principle 
1 The basic purpose of farms is to pr oduce RACs and RACs are the essential 
products of farms. 
2 Activities that involve RACs and that fa rms traditionally do for the purposes of 
growing their own RACs, removing them fr om the growing areas, and preparing 
them for use as a food RAC, and for packing, holding and transporting them, 
should all be within th e definition of “farm.” 
3 Activities should be classifi ed based in part on whether the food operated on is a 
RAC or a processed food, and on whether the activity transforms a RAC into a 
processed food. 146 
 
No. Organizing Principle 
4 Activities farms may perform on othe rs’ RACs should appropriately be 
classified as manufacturi ng/processing, packing, or holding in the same manner 
as these activities are classified off-farm  when the RACs are to be distributed 
into commerce. 
5 Manufacturing/processin g, packing, or holding food-- whether RACs or 
processed foods, from any source-- for consumption on the farm should remain 
within the farm definition. 
 
 
We are proposing to include definitions for tw o types of establishments (i.e., “farm” and 
“mixed-type facility”) and five types of  activities (i.e., “har vesting,” “holding,” 
“manufacturing/processing,” “packaging,” and “pack ing”), to reflect the organizing principles 
articulated immediately above and to clarify how those definitions  apply to specific activities 
depending on where the activities take place, th e food used in the activities, where the food 
comes from, and where the food is consumed.  We  discuss these proposed definitions in this 
section because they are inter-r elated; however, we propose that they appear in § 112.3(c) in 
alphabetical order with the other definitions di scussed in section V.A.2.b.iii of this document 
below. 
We are proposing to define “farm” to mean  a facility in one ge neral physical location 
devoted to the growing and harv esting of crops, the raising of animals (including seafood), or 
both.  The term "farm" includes: (i) Facilities th at pack or hold food, provi ded that all food used 
in such activities is grown, raised, or consumed  on that farm or another farm under the same 
ownership; and (ii) Facilities th at manufacture/process food, provide d that all food used in such 
activities is consumed on that farm or anot her farm under the same ownership.  The proposed 
definition of “farm” is based on the definition al ready established in § 1.2 27(b) in the section 415 
registration regulations, except that it does not include the statement “Washing, trimming of 
outer leaves of, and cooling pr oduce are considered part of ha rvesting.”  The description of 147 
 
harvesting activities is included in  a separate proposed definition of “harvesting” and thus would 
be redundant in the proposed definition of “farm.”  
We are proposing to define “Mixed-type facili ty” to mean an establishment that engages 
in both activities that are exempt from regi stration under section 415 of the FD&C Act and 
activities that require the establishment to be registered.  This term and its definition were 
initially developed in the preamble to the propos ed rule on food facility  registration (68 FR 5378 
at 5381) and in the interim final rule on f ood facility registration (68 FR 58894 at 58906-7, 
58914, 58934-8).  The proposed definition would also prov ide, as an example of such a facility, a 
definition of a “farm mixed-type facility.” A “farm mixe d-type facility” would be defined as an 
establishment that grows and harvests crops or  raises animals and may conduct other activities 
within the farm definition, but also conducts acti vities that require the establishment to be 
registered.  This definition is important to incl ude in this rule because the activities of farm 
mixed-type facilities that are within  the definition of “farm” are pot entially subject to this rule, as 
provided in proposed § 112.4.  FDA w ould apply this proposed rule on ly to the “farm” portion of 
these establishments’ activities, and not to th e “non-farm” portion of their activities (which 
would be subject to section 418 of the FD&C Act a nd therefore not subject to this proposed rule, 
consistent with section 419(h) of the FD&C Act).  Put another way, farms and the “farm” portion 
of the activities of farm mixed-type facilities would be subject to th is proposed rule as 
applicable.  For simplicity, FDA proposes to refe rence these activities co llectively in proposed § 
112.4(a) as one aspect of what makes an entity  a “covered farm” and then to refer only to 
“covered farms” throughout the proposed rule.  T hus, references to “farms” and “covered farms” 
throughout this proposed rule shou ld be understood to include the portion of a farm mixed-type 
facility’s activities that ar e within the farm definition. 148 
 
We are proposing to define the term “Harvest ing” to apply to farms and farm mixed-type 
facilities and be defined as activities that are traditionally performed by farms for the purpose of 
removing raw agricultural commodities from the pl ace they were grown or raised and preparing 
them for use as food.  Harvesting would be lim ited to activities perfor med on raw agricultural 
commodities on the farm on which they were grow n or raised, or another farm under the same 
ownership.  Harvesting would not include activities that transform a raw agricultural commodity, 
as defined in section 201(r) of the FD&C Act, into a processed food as defined in section 201(gg) of the FD&C Act.  Gathering, washing, tr imming of outer leaves of, removing stems and 
husks from, sifting, filtering, threshing, shel ling, and cooling  raw agricultural commodities 
grown on a farm or another farm under the same ownership would be listed as examples of harvesting.  This proposed definiti on would include the same exampl es of “harvesting” that are 
currently part of the farm definition in § 1.227( b)(3) (washing, trimming of outer leaves, and 
cooling) and would add other examples to help cl arify the scope of the definition of harvesting.   
“Harvesting” is a category of activities that is  only applicable to farms and farm mixed-type 
facilities.  Activities that would be “harvesti ng” when performed on a farm on the farm’s own 
RACs would be classified differently under other circumstances, such as at a processing facility 
that is not on a farm, or when performed by a farm on others’ RACs.  For example, at an off-
farm facility that packs tomatoes, washing the tomatoes after they are received would not be “harvesting” because it is not being performed on the farm that produced the tomatoes (or 
another farm under the same ownership).  Instea d, washing tomatoes at the off-farm packing 
facility would be “manufactur ing,” because it involves preparing, treating, modifying, or 
manipulating food.   149 
 
We are proposing to define “Holding” to  mean the storage of food. The proposed 
definition would state that, for farms and farm mixed-type facilities, hol ding would also include 
activities traditionally performed by farms for the safe or effective storage of RACs grown or raised on the same farm or another farm unde r the same ownership, but would not include 
activities that transform a RAC, as defined in section 201(r) of the FD&C Act, into a processed 
food as defined in section 201(gg) of the FD&C Act.   This would mean that more activities than 
just storage of food would be cla ssified as “holding” when a farm  or farm mixed-type facility 
performs those activities on its own RACs.  For example, fumi gating or otherwise treating a 
farm’s own RACs against pests for the purpose of safe and effective storage would be “holding” 
under this proposed definition.  However, fumigating or otherwise treating food against pests under other circumstances (such as off-farm or by a farm handling others’ RACs) would not be 
“holding” food because it is not  storage of food, which would remain the definition of holding 
applicable to most circumstances. 
We are proposing to define “Manufacturing/ processing” to mean making food from one 
or more ingredients, or synthesizing, prep aring, treating, modifying or manipulating food, 
including food crops or ingredients.  The proposed  definition would also st ate that, for farms and 
farm mixed-type facilities, manu facturing/processing would not incl ude activities that  are part of 
harvesting, packing, or holding.  Under this proposed definiti on, the expanded definitions of 
“packing” and “holding,” and th e extra category “harvesting, ” would apply to activities 
performed by farms and farm mixed-type facili ties on their own RACs.  These expanded and 
extra categories would not apply off-farm or to foods other than a farm’s own RACs or a farm 
mixed-type facility’s own RACs.  Thus, some activities that would otherwise be 
manufacturing/processing would instead be defi ned as packing, holding, or  harvesting by virtue 150 
 
of being performed by a farm or farm mixed-type  facility on its own RA Cs.  Accordingly, these 
activities would not be manufacturing/processing b ecause they would already be classified into 
the expanded definitions of packing or holding, or into the extra category of harvesting. 
We are proposing to define “Packaging” to mean (when used as a verb) placing food into 
a container that directly contacts  the food and that the consumer receives.  We are proposing to 
use the same definition of “packaging” as  is currently established in § 1.227.   
We are proposing to define “Packing” to m ean placing food into a container other than 
packaging the food. The proposed definition would also state that, for farms and farm mixed-
type facilities, packing woul d also include activities  (w hich may include packaging) 
traditionally performed by farms to prepare RACs grown or raised on the same farm or another farm under the same ownership for storage and tr ansport, but would not include activ ities that 
transform a RAC, as defined in section 201(r) of th e FD&C Act, into a processed food as defined 
in section 201(gg) of th e FD&C Act.  This would mean that  more activities than just placing 
food into a container other than p ackaging would be classified as “packing” when a farm or farm 
mixed-type facility performs those activities on its own RACs.  For example, packaging (placing 
food into a container that directly  contacts the food and that the consumer receives) a farm’s own 
RACs would be “packing” under this definition because farms traditionally do this to provide 
greater protection for fragile RACs than would be possible if the RACs were placed in containers 
other than the consumer container, and because  this activity does not transform a RAC into a 
processed food.  However, packaging food under other circumstances would not be “packing” 
food because packaging is explicitly excluded from  the definition of packing applicable to most 
circumstances (placing food into a container other than packaging).  Other examples of activities 
that could be packing when performed by a farm or a farm mixed-type facility on its own RACs 151 
 
include packaging or packing a mix of RACs t ogether (e.g., in a bag containing three different 
colored bell peppers, or a box of mixed produce fo r a community sponsored agriculture program 
farm share); coating RACs with wax, oil, or resi n coatings used for the purposes of storage or 
transport; placing stickers on RACs; labeling pa ckages containing RACs; sorting, grading, or 
culling RACs; and drying RACs for the purpose of storage or transport.   
Table 3 provides examples of how we woul d classify activities conducted off-farm and 
on-farm (including farm mixed-type facili ties) using these proposed definitions.  
 
Table 3. Classification of Activities Conduc ted Off-Farm and On-Farm (Including Farm 
Mixed-Type Facilities) 
 
Classification Off Farm On Farm (inc luding farm mixed-type facilities) 
Notes:  Not applicable.  
Harvesting is a 
classification that only applies on farms and farm 
mixed-type facilities. Notes:  Activities traditionally performed by farms for the purpose of 
removing RACs from growing areas and preparing them for use as food.  
Harvesting is limited to activities performed on RACs on the farm on which they were grown or raised, or another farm under the same ownership.  
Harvesting does not include activities that change a RAC into processed food.  
Activities that are harvesting are within the farm definition.  
 
 Harvesting 
Examples:   Not applicable. Examples:  activities that fit this definition when performed on a farm’s “own 
RACs” (a term we use to include RACs grown or raised on that farm or 
another farm under the same ownership) include gathering, washing, 
trimming of outer leaves, removing stems and husks, sifting, filtering, threshing, shelling, and cooling.  These activities, performed on a farm’s 
own RACs, are inside the farm definition.  
 
Notes:  Placing food in a 
container other than 
packaging the food (where 
packaging means placing food into a container that 
directly contacts the food 
and that the consumer receives).   
 
 Notes:  Placing food in a container other than packaging the food (using the 
same definition of packaging), or activities (which may include packaging) 
traditionally performed by farms to prepare RACs grown or raised on that 
farm or another farm under the same ownership for storage or transport.  Packing does not include activities that change RAC into a processed food.  
Activities that are packing are within the farm definition when they are 
performed on food grown, raised, or consumed on that farm or another farm under the same ownership; under any other circumstances they are outside the 
farm definition. Packing 
Examples:  putting 
individual unit cartons into a 
larger box used for Examples:  activities that fit the definition of packing when performed on a 
farm’s own RACs include packaging, mixing, coating with wax/oil/resin for 
the purpose of storage or transport, s tickering/labeling, drying for the purpose 152 
 
Classification Off Farm On Farm (inc luding farm mixed-type facilities) 
shipping, and putting 
articles of produce in non-
consumer containers (such 
as shipping crates).  of storage or transport, and sorting/grading/culling.  These activities, 
performed on a farm’s own RACs, are inside the farm definition.   
 
Activities that fit the definition of packing when performed on a farm on any other foods, including RACs grown or raised on a farm not under the same 
ownership, include putting individual unit cartons into a larger box used for 
shipping, and putting articles of produce in non-consumer containers (such as shipping crates) -- the same activities that fit the definition of packing off 
farm.  These activities, performed on fo od other than a farm’s own RACs, 
are outside the farm definition unless done on food for consumption on 
the farm.  
 
Notes : Storage of food.   
 Notes:  Storage of food, or activities traditionally performed by farms for the 
safe or effective storage of RACs grown or raised on that farm or another 
farm under the same ownership.  Holding does not include activities that 
change a RAC into a processed food.  Activities that are holding are within the 
farm definition when they are performed on food grown, raised, or consumed 
on that farm or another farm under the same ownership; under any other 
circumstances they are outside the farm definition.  
 Holding 
Example:  storing food, such 
as in a warehouse. Examples:  activities that fit the definition of holding when performed on a 
farm’s own RACs include fumigating during storage, and storing food, such as in a warehouse. These activities, performed on a farm’s own RACs, are 
inside the farm definition.   
 
An activity that fit the definition of holding when performed on a farm on any 
other foods, including RACs grown or raised on a farm not under the same 
ownership, is storing food, such as in a warehouse -- the same activity that fits the definition of holding off farm.  This activity, performed on food 
other than a farm’s own RACs, is outs ide the farm definition unless done 
on food for consumption on the farm.  
 
Notes:  Making food from 1 
or more ingredients, or synthesizing, preparing, 
treating, modifying, or 
manipulating food.  Includes packaging (putting food in a 
container that directly 
contacts food and that consumer receives).   Notes:  Making food from 1 or more ingredients, or synthesizing, preparing, 
treating, modifying, or manipulating food; except for things that fall into the categories of harvesting, packing, or holding (see rows above).  Activities that 
are manufacturing/processing are outside the farm definition unless done on 
food for consumption on the farm.  
 Manufacturing/ Processing 
Examples:  activities that fit 
this definition include 
washing, trimming of outer leaves, removing stems and 
husks, sifting, filtering, 
threshing, shelling, cooling, packaging, mixing, coating, 
stickering/labeling, drying, 
sorting/grading/culling not 
incidental to packing or 
holding, fumigating, slaughtering animals or 
post-slaughter operations, Examples:  activities that fit the definition of manufacturing/processing when 
performed on a farm’s own RACs include slaughtering animals or post-
slaughter operations, irradiation, cutting/coring/chopping/slicing, canning, coating with things other than wax/oil/resin, drying that creates a distinct 
commodity, artificial ripening, cooking, pasteurizing/homogenizing, infusing, 
distilling, salting, smoking, gr inding/milling, and freezing. These activities, 
performed on a farm’s own RACs, ar e outside the farm definition unless 
done on food for consumption on the farm.  
 
Activities that fit the definition of manufacturing/processing when performed 
on a farm on any other foods, including RACs grown or raised on a farm not under the same ownership include washing, trimming of outer leaves, 
removing stems and husks, sifting, filtering, threshing, shelling, cooling, 153 
 
Classification Off Farm On Farm (inc luding farm mixed-type facilities) 
irradiation, 
cutting/coring/chopping/slic
ing, canning, artificial 
ripening, cooking, pasteurizing/homogenizing, 
infusing, distilling, salting, 
smoking, grinding/milling, and freezing. packaging, mixing, coating, stickering/labeling, drying, 
sorting/grading/culling not incidental to packing or holding, fumigating, 
slaughtering animals or post-sla ughter operations, irradiation, 
cutting/coring/chopping/slicing, canning, artificial ripening, cooking, pasteurizing/homogenizing, infusing, distilling, salting, smoking, 
grinding/milling, and freezing-- the same  activities that fit the definition of 
manufacturing/processing off farm.  These activities, performed on food 
other than a farm’s own RACs, are ou tside the farm definition unless 
done on food for consumption on the farm.  
 
 
 ii. Proposed Definitions of “Very Sm all Business” and “Small Business” 
Summary of Proposed Qualifications (on a rollin g basis, average annual monetary value of food 
sold during the previous  three-year period) 
 
Above $250,000 and no more than $500,000  Small Business 
Above $25,000 and no more than $250,000 Very Small Business 
$25,000 or less Excluded from coverage 
 
As required by section 419(a)(3 )(F) of the FD&C Act, proposed § 112.3(b) defines the terms 
“very small business” and “small bus iness” for purposes of this proposed rule only.  FDA uses a 
measure of the average annual m onetary value of food sold to determine farm size.  This 
measure should serve as a valid proxy for both the volume and value of production within size 
category and commodities.  The USDA National Commission on Small Farms recommended a definition for a small farm as a family farm w ith less than $250,000 annual monetary value of all 
commodities sold 
(Ref. 85).  The Commission’s recommendation was based on the reasoning that 
these farms are the likeliest to exit the industry, and have the great est need to improve net farm 
incomes (Ref. 85).  The Commission states that although 94% of all U.S. farms generate less than 
$250,000 annual monetary value of all commodities so ld, their revenue constitutes only 41% of 154 
 
total gross revenue from all farms (Ref. 85).  We propose to use the $250,000 annual monetary 
value of food sold threshold for our cutoff of a very small farm since the revenue of covered 
produce farms below this threshold constitutes on ly 12% of total gross revenue from food sales 
by produce farms and make up 83% of all produce fa rms.  We propose to use the statutory cutoff 
of $500,000 annual monetary value of food sold as one part of the criteria for the qualified 
exemption in section 419(f) of the FD&C Act (implemented in proposed § 112.5) as the 
threshold for a small farm.  Farms below the $500,000 annual value of food sold cutoff make up 
89% of covered farms, and their revenue constitu tes 18% of total gross revenue from food sales 
by produce farms.  We developed this proposed definition using sales class breaks found in 
generally available information from USDA (Ref. 86).   
  Proposed § 112.3(b)(1) would define your farm to  be a very small business if it is subject 
to proposed part 112 and, on a rolling basis, the average annual monetary value of food you sold 
during the previous three-year pe riod is no more than $250,000.   
Proposed § 112.3(b)(2) would define your farm to be  a small business if it is subject to proposed 
part 112 and, on a rolling basis, the average a nnual monetary value of food you sold during the 
previous three-year period is no more than $500,000;  and your farm is not a very small business 
as provided in proposed  § 112.3(b)(1). For clarity, in both proposed §§ 112.3(b )(1) and (2), the limitation “if it is subject to this part” is 
intended to exclude farms not subj ect to the proposed rule per proposed § 112.4(a), that is, farms 
with $25,000 or less of annual value of food sold.  As discussed in section V.A.2.c of this 
document, we propose to exclude such farms from the coverage of this proposed rule such that 
there would be no reason for them to be clas sified as small or very small businesses. 
iii. Additional Proposed Definitions 155 
 
Proposed § 112.3(c) would establish the following a dditional definitions that would apply for the 
purposes of part 112. We propose to define “adequate” to mean that which is needed to accomplish the intended purpose in keeping with good public h ealth practice.  This proposed definition is the same as the 
definition we have established in § 110.3 with respect to curre nt good manufacturing practice in 
manufacturing, packing, or holding human food.  We have been a pplying this definition for the 
purpose of enforcing the regulations  in part 110 for more than 40 years and tentatively conclude 
that it would be an appropriat e definition to apply to part  112 as well.  Throughout this 
document, we provide examples of what we m ean by “adequate” for purposes of complying with 
specific proposed provisions.  We propose to define “adequately reduce microor ganisms of public health significance” to mean 
reduce the presence of such microorganisms to an extent sufficient to prevent illness.  This 
proposed definition would establish in part 112 a definition that we have used in guidance 
associated with the risk of foodborne illness from pathogens 
(Ref. 87.Ref. 88).  As discussed in 
those documents, the extent of reduction sufficient to prevent illness is usually determined by the 
estimated extent to which a pathogen may be presen t in the food combined w ith a safety factor to 
account for uncertainty in that estimate. For exam ple, if it is estimated that there would be no 
more than 1000 (i.e., 3 logs) Salmonella organism s per gram of food, and a safety factor of 100 
(i.e., 2 logs) is employed, a process that adequa tely reduces Salmonella spp. would be a process 
capable of reducing Salmonella s pp. by 5 logs per gram of food. 
We propose to define “agricultural tea” to mean a water extract of biological materials (such as 
humus, manure, non-fecal animal byproducts, peat moss, pre-consumer vegetative waste, table 
waste, or yard trimmings), excl uding any form of human waste, produced to transfer microbial 156 
 
biomass, fine particulate organic matter, and soluble chemical components into an aqueous 
phase.  Agricultural teas are held  for longer than one hour before application.  We developed this 
term to cover a wide range of “teas” used in pr oduction of fresh produce, but not to include “tea” 
served as a beverage.  The term “agricultural t ea” was based in part on the definition of “compost 
tea” developed by the National Organic Standards Board (Ref. 89).  Human waste would be 
excluded for consistency with proposed § 112.53 re garding the use of human waste as a soil 
amendment.  The one hour limitation is intended to distinguish between agricultural teas and 
other liquids such as leachate and runoff and is consistent with the recommendations of the 
recommendations of the National Organic Standards Board (Ref. 36).  
We propose to define “agricultural tea additive” to mean a nutrient source (such as molasses, 
yeast extract, or algal powder) added to agricultur al tea to increase microbial biomass.  The term 
“agricultural tea additive” was based in part on the definition of “compost tea additive” developed by the National Organic Standards Board 
(Ref. 89). 
We propose to define “agricultura l water” to mean water used in  covered activities on covered 
produce where water is intended to, or is likely  to, contact covered pr oduce or food-contact 
surfaces, including water used in growing activi ties (including irrigation water applied using 
direct water application methods, water used for preparing crop sprays, and water used for 
growing sprouts) and in harves ting, packing, and holding activiti es (including water used for 
washing or cooling harvested produce and water used for preventing dehydration of covered 
produce).  This proposed definition is different fr om our definition of agricultural water in our 
Good Agricultural Practices guide (Ref. 10) both because it is not limited to water in the growing 
environment, and because we have excluded wate r that does not contact covered produce from 
this definition based on the information in our QAR. 157 
 
We propose to define “animal excreta” to mean solid  or liquid animal waste.  By contrast, we are 
proposing to define “manure” to mean animal excret a, alone or in combination with litter (such 
as straw and feathers used for animal bedding) for use as a soil amendment.  We are proposing 
definitions to distinguish “animal excreta” from  “manure” based on whether the animal excreta 
is used as a soil amendment because some propos ed requirements make su ch a distinction.  For 
example, the proposed requirements in §§ 112.54 and 112.56 are directed to the treatment and 
safe application of biological soil amendments of animal origi n, including manure intentionally 
used as a soil amendment, and the propos ed requirements in §§ 112.82 and 112.83 would be 
directed to preventing contamination of covere d produce with animal ex creta deposited by wild 
or domestic animals that intrude in an area wh ere a covered activity is  conducted on covered 
produce.  The proposed definition of “manure” also accounts for the potential inclusion of 
animal litter that is collected with  animal excreta, e.g., from barns. 
We propose to define “application interval” to m ean the time interval betw een application of an 
agricultural input (such as a biol ogical soil amendment of animal origin) to a growing area and 
harvest of covered produce from the growing area  where the agricultural input was applied.  The 
proposed definition would provide a simple term to use when describing such a time interval.  
The proposed application intervals for biolog ical soil amendments in proposed § 112.56 would 
establish requirements regarding such time intervals. We propose 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 bioso lids, table waste, agricultural tea, or yard 
trimmings, alone or in combination.  We are prop osing this definition as a means to distinguish 
soil amendments that contain biological compon ents from those that do not (like chemical 158 
 
fertilizers).  In addition, we pr opose to define “biological soil amendment of animal origin” to 
mean a biological soil amendment which consists, in  whole or in part, of materials of animal 
origin, such as manure or non-fecal animal byproducts , or table waste, alone or in combination.  
The term “biological soil amendment of animal  origin” does not include  any form of human 
waste. We are proposing this definition as a means to distinguish these biological soil 
amendments from soil amendments that are wh olly plant-based (such as yard trimmings). 
We propose to define “composting” to mean a process to produce humus in which organic 
material is decomposed by th e actions of microorganisms unde r thermophilic conditions for a 
designated period of time (for example, 3 days) at a designated temperature (for example, 131°F 
(55 °C)), followed by a curing stage under cool er conditions.  The proposed definition is 
consistent with definitions or explanations of “compost” and “composting” in documents such as 
a State regulation (Ref. 90), Appendix B to 40 CFR part 503 (Ref. 91), documents prepared by the 
U.S. EPA (Ref. 92), and the Produce Safety Project I ssue Brief on Composting of Animal 
Manures (Ref. 27).  
We propose to define “covered activity” to mean growing, harvesting, packing, or holding 
covered produce, provided that a ll covered produce used in cove red packing or holding activities 
is grown, raised, or consumed on that farm or another farm under the same ownership.  Covered 
activities would not include ma nufacturing/processing within the definition elsewhere in 
proposed § 112.3(c).  As discussed in secti ons III.F and V.A.2.b.i of this document, 
manufacturing/processing on a farm is potentially subject to the coverage of Section 418 of the 
FD&C Act, unless all of the food used in such activities is co nsumed on that farm or another 
farm under the same ownership.  Where all of the manufactured/processe d food is consumed on 
that farm or another farm under the same owners hip, the activity would be potentially within the 159 
 
scope of Section 419 of the FD&C Act and this proposed rule, except that  Section 419(g) of the 
FD&C Act specifies that “[t]hi s section shall not apply to pr oduce that is produced by an 
individual for personal consumption,” and secti on 419(c)(1)(B) of the FD&C Act also requires 
that FDA ensure that the final rule is practicab le for “a small food processing facility co-located 
on a farm.”   FDA tentatively concludes that on-farm manu facturing/processing activities for on-farm 
consumption (like produce for individual consumption)  should not be subject to this rule, either 
because it is automatically excluded by Section 419( g) or because, to the extent there may be any 
difference between produce “for personal consum ption” and produce “consumed on the farm or 
another farm under the same ownership,” it is appropriate to exclude on-farm 
manufacturing/processing for on-farm consumpti on from the rule.  The definition of covered 
activity would also specify, for clarity, that this part  does not apply to activiti es of a facility that 
are subject to part 110 of this chapter .     
We propose to define “covered produce” to mean produce that is subject to the requirements of 
this part in accordance with §§ 112.1 and 112.2.  The term “covered produce” refers to the 
harvestable or harvested part of the crop.  We  are proposing to define “covered produce” to 
provide a simple term to use when describing f ood that would be within the scope of the rule 
under proposed § 112.1 and not exempt fr om the rule under proposed § 112.2. 
We propose to define “curing” to mean the ma turation 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 pha se of composting, to further reduce pathogens, 
promote further decomposition of cellulose and lignin, and stabilize composition.  This proposed 
definition is consistent with definitio ns of “curing” in a State regulation 
(Ref. 93), documents 160 
 
prepared by the U.S. EPA (Ref. 92), and a glossary of composting terms prepared by the Cornell 
Waste Management Institute (Ref. 94).  
We propose to define “direct water application method” to mean using agricultural water in a 
manner whereby the water is intended to, or is likely to, contact covere d produce or food-contact 
surfaces during use of the water.  This proposed definition would provide a simple term to use 
when describing such water within regulations such as proposed § 112.44(c).  By cross-reference 
to the definitions of “covered produce” and “produce”, this term only applies to methods in which the water is intended to, or is likely to, co ntact the harvestable part of the covered produce. 
We propose to define “food” to mean food as defi ned in section 201(f) of the FD&C Act and to 
include seeds and beans used to grow sprouts.  We have long considered seeds and beans used to 
grow sprouts to be “food” w ithin the meaning of secti on 201(f) of the FD&C Act 
(Ref. 95).  
Seeds and beans used to grow sprouts are both articles used for food and articles used for 
components of articles used for food.  We are proposi ng to include them specifically in the 
definition of food for purposes of this rule for clarity because sprouts are covered by this rule. 
We propose to define “food-contact surfaces” to mean those surfaces that contact human food 
and those surfaces from which drainage or othe r transfer onto the f ood or onto surfaces that 
contact the food ordinarily occurs during th e normal course of operations. “Food-contact 
surfaces” includes food-contact su rfaces of equipment and tools used during harvest, packing, 
and holding.  This proposed defini tion of “food-contact surfaces” is  consistent with the definition 
of this term in § 110.3 except that we propose to add the phrase “or other transfer” after 
“drainage” definition of “food-cont act surfaces” to clarify that surfaces from which any transfer 
involving liquids or non-liquids  onto the food or onto surfaces that contact the food are food-
contact surfaces. 161 
 
We propose to define “hazard” to mean any biologi cal agent that is reasonably likely to cause 
illness or injury in the absence of its control.  The proposed definition is consistent with the 
NACMCF HACCP guidelines, the Codex HACCP Annex, Federal HACCP regulations for 
seafood, juice, and meat and poultry, except that for the purposes of this ru le the term would be 
limited to biological hazards because, as discus sed in section IV.A. of  this document, this 
proposed rule is only addressing biological  hazards.  The NACMCF HACCP guidelines (Ref. 41) 
and our HACCP regulation for jui ce (§120.3(g)) define “hazard” and “food hazard,” respectively 
as a biological, chemical, or physic al agent that is reasonably likely  to cause illness or injury in 
the absence of its control.  The Codex HACCP A nnex defines “hazard” as a biological, chemical 
or physical agent in, or condition of, food with th e potential to cause an adverse health effect 
(Ref. 96).  Our HACCP regulation for seafood (§123.3( f)) and the FSIS HACCP regulation for 
meat and poultry (9 CFR 417.1) define “food safety  hazard” as any biological, chemical, or 
physical property that may cause a food to be un safe for human consumption.  We recognize that 
there are other hazards relevant to produce safety  on farm that would not be addressed in this 
proposed rule such as chemical, physical, and ra diological hazards (see se ction IV.B. of this 
document) and do not intend to suggest by this defi nition that such hazards are not hazards.  We 
request comment on whether we should instead use th e term “biological hazard s” in this rule.   
We propose to define “humus” to mean a stabil ized (i.e., finished) biological soil amendment 
produced through a controlled composting process.   We are proposing to use “humus” as the 
term to identify the final, mature product of  composting for the purpose of this rule.  Our 
proposed definition derives from our proposed de finitions for “composting” and “curing” and the 
Cornell Waste Management Institute’s glossary of composting terms (Ref. 94), which defines 
humus as a complex aggregate made during the decomposition of plant and animal residues; 162 
 
mainly derivatives of lignin, proteins, and cellu lose combined with inorganic soil parts.  
However, other relevant documents (Ref. 27.Ref. 92.Ref. 97) refer to the production of “humus-
like material” through composting, and humus can be produced by mechanisms other than the 
action of microorganisms (Ref. 98).  We request comment on wh ether our proposed definition 
and use of the term “humus” for the final product of composting is appropriate for the purpose of 
this rule, or whether we shoul d use a term other than “humus,” such as “mature compost.” 
We propose to define “manure” to mean animal excr eta, alone or in combination with litter (such 
as straw and feathers used for animal bedding) fo r use as a soil amendment.  As discussed above 
in the definition of animal excreta, this definiti on is intended to make a distinction between the 
terms “manure” and “animal excreta.” We propose to define “microorgani sms” to mean yeasts, molds, b acteria, viruses, protozoa, and 
microscopic parasites and to incl ude species having public health significance. As proposed, the 
term “undesirable microorganisms” includes thos e microorganisms that are of public health 
significance, that subject food to decomposition, th at indicate that food is contaminated with 
filth, or that otherwise may cause food to be a dulterated. The substantive difference between this 
proposed definition and that in current § 110.3 is  the addition of protozoa (e.g., Giardia lamblia
) 
and microscopic parasites (e.g., Cyclospora cayetanensis ).   Because such microorganisms are 
relevant to produce safety, we tentatively conclu de that it is reasonabl e to include them.   
 We propose to define “monitor” to mean to  conduct a planned sequence of observations or 
measurements to assess whether a process, poi nt, or procedure is under control, and, when 
applicable, to produce an accurate record of the observation or measurement.   
We propose to define “non-fecal animal byproduct” to  mean solid waste (other than manure) that 
is animal in origin (such as meat, fat, dairy pr oducts, eggs, carcasses, bl ood meal, bone meal, fish 163 
 
meal, shellfish waste (such as crab, shrimp, and l obster waste), fish emulsi ons, and offal) and is 
generated by commercial, institutional, or ag ricultural operations.  This proposed definition 
reflects the use of a similar term in sources such as the State of Florida’s regulations (Ref. 90).  
However, we are proposing to include more exam ples of these byproducts than are included in 
Florida’s regulations to clearly co mmunicate what we mean by the term. 
We propose to define “pest” to mean any objec tionable animals or inse cts including birds, 
rodents, flies, and larvae.  This proposed definition is consistent with the definition of “pest” in 
current § 110.3. We propose to define “pre-consumer vegetative waste” to mean solid waste that is purely 
vegetative in origin, not consider ed yard trash, and derived from commercial, institutional, or 
agricultural operations without co ming in contact with animal products, byproducts or manure or 
with an end user (consumer).  As proposed, pr e-consumer vegetative waste includes material 
generated by farms, packing houses, canning ope rations, wholesale distribution centers and 
grocery stores; products that have been removed from their packaging (such as out-of-date juice, 
vegetables, condiments, and bread); and associated packaging that is vegetative in origin (such as 
paper or corn-starch based products).  As pr oposed, pre-consumer vegetative waste does not 
include table waste, packaging that has come in c ontact with materials (suc h as meat) that are not 
vegetative in origin, or any wa ste generated by restaurants.  This proposed definition is 
consistent with a State regulation 
(Ref. 90). 
For the purpose of this rule, we propose to define the term “produce” to mean any fruit or vegetable (including mixes of intact fruits a nd vegetables) and includes mushrooms, sprouts 
(irrespective of seed source), p eanuts, tree nuts and herbs.  Fo r the purposes of this rule, we 
propose to define “fruit” as the edible reproduc tive body of a seed plant or tree nut (such as 164 
 
apple, orange and almond) such that fruit mean s the harvestable or harv ested part of a plant 
developed from a flower; and “veget able” as the edible part of an herbaceous plant (such as 
cabbage or potato) or fleshy fruiting body of a fu ngus (such as white but ton or shiitake) grown 
for an edible part such that ve getable 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, spr outs, and herbs (such as basil or cilantro).  
For the purposes of this rule, produce does not include “food grains” meaning the small, hard fruits or seeds of arable crops, or the crops bearing these fruits  or seeds, that are grown and 
processed for use as meal, flour, baked goods, cereal s and oils rather than for fresh consumption 
(including cereal grains, pseudo cer eals, oilseeds and other plants used in the same fashion).  
Examples of food grains include barley, dent- or flint-corn, so rghum, oats, rice, rye, wheat, 
amaranth, quinoa, buckwheat, cotton seed, and s oybeans. With this definition, we are proposing 
to specifically include mushrooms, sprouts (irres pective of seed source),  peanuts, tree nuts and 
herbs, and specifically exclude food grains.  We explain our proposed definition of “produce” in 
detail above, in section V.A.2.a of this doc ument.  We request comments on our proposed 
definition of “produce.”  We propose to define “production batch of sprouts”  to mean all sprouts that are started at the 
same time in a single growing unit (e.g., a single dr um or bin, or a single rack of trays that are 
connected to each other), whether or not the sprouts are grown from a single lot of seed 
(including, for example, when multiple types of seeds are grown within a single growing unit).  
Through this definition, we intend to treat as a production batch product that would be exposed 
to the same conditions during sprouting, such as multiple seed types grown in a common drum or 
multiple trays in a single rack that may be expo sed to water that has c ontacted other product in 165 
 
the same growing unit.   This term is used in  proposed subpart M.  Limiting the definition of 
"production lot" to a single gr owing unit would prevent sprout growers from "pooling" samples 
from multiple growing units within an operation whereby contamination in spent water in one 
unit could be diluted by non-contaminated water fr om other units to the point where pathogens 
might not be detected.  This proposed defin ition is consistent with our 1999 guidance for 
industry on sampling and microbial testing of sp ent irrigation water dur ing sprout production 
(Ref. 15).  We recognize that there ar e a diversity of growing practi ces and a variety of growing 
units that may represent different product vol umes, so we request comment on this proposed 
definition.   We propose to define “qualified end-user,” with respect to a food, to mean the consumer of the 
food; or a restaurant or retail food establishment (as those terms are defined in § 1.227) that is 
located (i) in the same State as the farm that pr oduced the food; or (ii) not more than 275 miles 
from such farm.  The definition would also st ate that the term “consumer” does not include a 
business.  This definition implements section 419( f)(4) of the FD&C Act.  We note that section 
419(f)(4)(A) of the FD&C Act does not provide for a different analysis for when an international 
border falls within the 275 miles;  thus, we tentatively conclude that international borders should 
not affect the distance calcula tion.  Thus, for example, a farm in Mexico selling food to a 
restaurant or retail food establishm ent in the U.S. that is within 275 miles of the farm could count 
that sale as a sale to a qualified end user.  As another example, the same would also be true for a 
U.S. farm selling food to a restaurant or retail food establishment in Mexico that is within 275 
miles of the farm.  Finally, we also note that the requirements related to  distance (in the same 
state or within 275 miles of the farm) only appl y to restaurants and retail food establishment 166 
 
customers, and not to consumers.  Thus, a farm may count any sale directly to a consumer as a 
sale to a qualified end-user. We propose to define “raw agricultural co mmodity (RAC)” to m ean “raw agricultural 
commodity” as defined in section 201(r) of the FD&C Act.  We propose to include this reference to the FD&C Act definition to provide additiona l clarity regarding the meaning of this term. 
We propose to define “reasonably foreseeable ha zard” to mean a potential hazard that may be 
associated with the farm or the food.  We provide a proposed definition for this term as it is used 
in section 419(c)(1)(A) of the FD &C Act and reflected in severa l requirements proposed in this 
rule.  As noted in the discussion of the proposed  definition of “hazard” in this section, this 
definition would be limited to biological haza rds because those are the only hazards we are 
currently proposing to address in this rule.  We recognize that there are other reasonably 
foreseeable hazards relevant to produce safety on farm that would not be addressed in this 
proposed rule such as chemical, physical, and ra diological hazards (see se ction IV.B of this 
document) and do not intend to suggest by this de finition that such hazards are not reasonably 
foreseeable.  We request comment on whether we should instead use the term “reasonably 
foreseeable biological hazards” in this rule. We propose to define “sanitize” to mean to adeq uately treat cleaned food-contact surfaces by a 
process that is effective in destroying vege tative cells of microorganisms of public health 
significance, and in substantially  reducing numbers of other un desirable microorganisms, but 
without adversely affecting the product or its sa fety for the consumer.  This proposed definition 
is consistent with  the existing § 110.3 definition for “sanitize” except that we propose to include 
the term “cleaned” before “food-cont act surfaces.”  It is well esta blished that sanitizers can be 167 
 
inactivated by organic material and, thus, ar e not effective unless used on clean surfaces (Ref. 
99).  This proposed definition is consistent w ith the definition of “sanitize” in § 111.3. 
We propose to define “sewage sludge biosolids”  to mean the solid or semi-solid residue 
generated during the treatment of domestic sewage  in a treatment works within the meaning of 
the definition of ‘sewage sludge’ in 40 CFR 503.9( w).  This proposed definition is consistent 
with that of the U.S. Environmental Protection Agency (EPA), which has regulatory jurisdiction 
over treated domestic sewage a nd has established terms to desc ribe specific types of treated 
waste. We propose to define “soil amendment” to mean any chemical, biological , or physical material 
(such as elemental fertilizers, humus, manure,  non-fecal animal byproducts, peat moss, perlite, 
pre-consumer vegetative waste, sewage sludge bi osolids, table waste, ag ricultural tea and yard 
trimmings) intentionally added to the soil to im prove the chemical or physical condition of soil 
in relation to plant growth or to improve the cap acity of the soil to hold water.  This proposed 
definition is consistent with commonly used de finitions in industry guidelines and marketing 
agreements 
(Ref. 46.Ref. 31).  We also propose to include within the meaning of “soil 
amendment” growth media that serve as the en tire substrate during th e growth of covered 
produce (such as mushrooms and some sprouts). While  this inclusion is not consistent with the 
common usage of the term, it provides convenience si nce it is addressing the identical standards 
that we are proposing for identical hazards that exist for such growth media and soil 
amendments.  We propose to define “spent spro ut irrigation water” to mean water that has been used in the 
growing of sprouts.  This defi nition is intended to minimize the potential for confusion between 
spent sprout irrigation water and water used for irrigation of other types of covered produce.   168 
 
We are proposing to define “sta tic composting” to mean a proce ss 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 en closed vessel) by a mechanism that  does not include turning.  As 
proposed, examples of structural features for introducing air would include embedded perforated 
pipes and a constructed permanent base that incl udes aeration slots.  As  proposed, examples of 
mechanisms for introducing air include passive diffusion and mechanical means (such as blowers that suction air from the composting material or  blow air into the composting material using 
positive pressure).  The proposed definition derives from definitions and explanations of “static 
composting” in documents such as prepared by the U.S. EPA 
(Ref. 92), the Produce Safety 
Project Issue Brief on Com posting of Animal Manures (Ref. 27), and a report from the Food and 
Agriculture Organization of the United Nations (Ref. 100).  
We propose to define “surface water” to mean all water which is open to the atmosphere and subject to surface runoff, including water obtained  from an underground aquifer that is held or 
conveyed in a manner that is open to the atmo sphere, such as in canals, ponds, other surface 
containment or open conveyances.  This proposed definition is consistent with EPA’s definition 
and with common usage of the term “surface water” 
(Ref. 101).  We propose to define this term 
to distinguish “surface water” from other water, such as water from an underground aquifer that 
has not been held or conveyed in a manner open to the environment (“ground water”) because there is a greater likelihood that surface water could become contaminated, for example, by 
surface runoff.  We propose to define “table waste” to mean any post-consumer food waste, irrespective of 
whether the source material is animal or ve getative in origin, deri ved from individuals, 
institutions, restaurants, retail operations, or other sources where the food has been served to a 169 
 
consumer.  This definition is intended to di stinguish post-consumer food waste from pre-
consumer vegetative waste. We propose to define “turned composting” to me an a process to produce humus in which air is 
introduced into biological materi al (in a pile, row, or enclosed  vessel) by turning on a regular 
basis. Turning is the process of  mechanically mixing biological  material that is undergoing a 
composting process with the specific intention of moving the outer, cooler sections of the 
material being composted to the inner, hotter sections. The proposed  definition is consistent with 
definitions or explanations of “windrow composting” in documents prepared by the U.S. EPA 
(Ref. 92.Ref. 91), the Produce Safety Project Issue Br ief on Composting of Animal Manures (Ref. 
27), and a report from the Food and Agricult ure Organization of the United Nations (Ref. 100).  
We are proposing to use the term “turned composti ng” rather than “windrow  composting” so that 
the term describing this method woul d not be limited to use in “rows.” 
We propose to define “water distribution system ” to mean a system to carry water from its 
primary source to its point of use, including pipe s, sprinklers, irrigation canals, pumps, valves, 
storage tanks, reservoirs, meters, and fittings.  The proposed definition would provide a simple 
term to use when describing such systems. We propose to define “we” to mean the U.S. Food and Drug Administration.   We propose to define “yard trimmings” to mean purely vegetative matter resulting from 
landscaping maintenance or land clearing operations, including materials such as tree and shrub 
trimmings, grass clippings, palm fronds, trees, tree stumps, untreated lumber, untreated wooden 
pallets, and associated rocks and soils. This propos ed definition is consistent with a definition in 
State composting regulations 
(Ref. 90), except that we are propos ing to use the term “yard 
trimmings” rather than “yard trash.”  We are proposing to use the term “yard trimmings” to 170 
 
avoid potentially negative connot ations associated with the wo rd “trash,” even though some 
components of our proposed definition (e.g., untreated wooden pallets ) arguably are not 
“trimmings.”  We request comment on whether our  proposed use of the term “yard trimmings” is 
appropriate for the purpose of this rule, or wh ether we should propose to use a term other than 
“yard trimmings,” such as “y ard trash” or “yard waste.” 
We propose to define “you” to mean a person who is  subject to some or all of the requirements 
in this part.   
c. Persons Subject to this Rule Proposed § 112.4(a) states that, except as provid ed in paragraph (b) of  that section, if you 
are a farm or farm mixed-type facility with an  average annual monetary value of food (as “food” 
is defined in § 112.3(c)) sold during the previous  three-year period of more than $25,000 (on a 
rolling basis), you are a “covered fa rm” subject to this part; however, specific exemptions and 
partial exemptions apply.  If you are a covered fa rm subject to this part, you must comply with 
all applicable requirements of this part when you conduct a covered activ ity on covered produce.  
We are proposing to apply this proposed rule only  to farms and farm mixed-type facilities with 
an average annual monetary valu e of food (as “food” is define d in § 112.3(c)) sold during the 
previous three-year period of more than $25,000 (on a rolling basis) because we have tentatively 
concluded that farms with $25,000 or less in sale s do not contribute significantly to the produce 
market.  Farms below the $25,000 limit collectiv ely account for only 1.5% of covered produce 
acres, suggesting that they cont ribute little exposure to the ov erall produce consumption.  We 
note that such farms are and will continue to be covered under the adulteration provisions and 
other applicable provisions of the Federal Food, Drug, and Cosmetic Act and applicable 171 
 
implementing regulations, irrespective of whether they are included within the scope of this 
proposed rule.   
As proposed, § 112.4(a) would make clear that th e rule applies to both farms and farm mixed-
type facilities, and that such entities would be subject to the rule when they conduct a covered 
activity on covered produce, as those terms ar e defined in proposed § 112.3(c).  This would 
mean that, for example, a farm mixed-type faci lity that is a covered farm and that grows, 
harvests, packs, and holds its own lettuce would be subject to the proposed rule when conducting 
those activities (unless an exemption applies, such  as that in proposed § 112.4(b)).  However, the 
covered farm would not be subject to the rule  when conducting other activities that are not 
covered activities, or when conducting operati ons on food other than covered produce.  For 
example, if the farm mixed-type facility ap plied a manufacturing/pro cessing step (such as 
chopping) to its lettuce for dist ribution into commerce (i.e., not for consumption on the farm or 
another farm under the same ownership, or for personal consumption), this would not be a 
“covered activity” as that  term is defined in proposed § 112.3(c) and would therefore not be 
subject to this rule.    In proposed § 112.4(b), we  propose to state that you  are not a covered farm 
if you satisfy the requirements in § 112.5 and we have not withdrawn your exemption in accordance with the requirements of subpart R of this part.  This implements section 419(f) of 
the FD&C Act and is discussed further immediately below. d. Qualified Exemptions i. Criteria for Eligibility for a Qualified Exemption Proposed § 112.5(a) establishes the criteria fo r eligibility for a qua lified exemption and 
associated special requirements based on average m onetary value of all food sold and direct farm 
marketing. This exemption is mandated by Section 419(f) of the FD&C Act.  Except as provided 172 
 
in § 112.6, you would be exempt from all of the requirements of this part, except proposed 
subparts except A, Q, and R, in a calendar year if: 
• During the previous 3-year period preceding the applicable calendar year, the average 
annual monetary value of the food you sold di rectly to qualified end-users during such 
period exceeded the average a nnual monetary value of the food you sold to all other 
buyers during that period (§ 112.5(a)(1)); and  
• The average annual monetary value of all food you sold during the 3-year period 
preceding the applicable calendar year was less than $500,000, adjusted for inflation (§ 
112.5(a)(2)).  
Proposed § 112.5(b) provides that, for the purpose  of determining whether the average annual 
monetary value of all food sold during the 3-year  period preceding the ap plicable calendar year 
was less than $500,000, adjusted for inflation, the base line year for calculating the adjustment for 
inflation is 2011.  The conditions related to aver age annual monetary value established in section 
419(f)(1)(B) of the FD&C Act allow adjustment for inflation.  To establis h a level playing field 
for all farms that may satisfy the criteria fo r the qualified exempti on, we are proposing to 
establish the baseline year for the calculation in proposed § 112.5(a)(2).  We are proposing to 
establish 2011 as the baseline year for inflation because 2011 is the year that FSMA was enacted 
into law.   Section 419(f) of the FD&C Act does not specifically target arrangements such as community-
sponsored agriculture (CSA), you-pick operations, or  farmers markets.  It does seem likely that 
many such operations will meet the criteria fo r qualified exemption.  E ach such operation would 
need to analyze its sales under the terms of § 112. 5 to determine its eligib ility for the qualified 
exemption.  For example, if a you-pick operation has an average annual monetary value of food 173 
 
sold during the relevant 3-y ear period of less than $500,000, and all of its sales were to 
individuals who come to the farm to pick their own produce, all of its sales would be sales to 
consumers (who are qualified end-us ers, regardless of location) fo r the purpose of determining 
the proportion of the sales that ar e to qualified end-users.  In th is example, the you-pick farm 
would be eligible for the qualified exemption.  As another example, if a CSA farm has an 
average annual monetary value of food sold dur ing the relevant 3-year period of less than 
$500,000; and 25% of the monetary value of its sale s comes from sales to individual consumers 
enrolled in the CSA, 50% of the monetary value of its sales comes from sales to restaurants in 
the same state as the farm, and 25% of the moneta ry value of its sales co mes from sales to other 
buyers who are not qualified end-users; the CS A farm would be eligible for the qualified 
exemption.  In this example, the CSA farm’s sa les to qualified end-users (consumers and in-state 
restaurants) make up 75% of the average annual monetary value of food sold, so the value of the 
farm’s sales to qualified end-users exceed the va lue of its sales to al l other buyers during the 
relevant time period.    
ii. Applicable Requirements for Qualified Exemptions Proposed § 112.6 establishes the requirements that apply to you if you are eligible for a qualified 
exemption in accordance with § 112.5.  Proposed § 112.6(a) explains that subparts A, Q, and R 
remain applicable to those who qualify for a qua lified exemption under § 112.5.  This is because 
subpart A contains this provisi on and other general provisions such as definitions, Subpart Q 
contains provisions related to compliance and enforcement, and subpart R contains provisions 
necessary to implement section 419 (f)(3) of the FD&C Act, as disc ussed further in section V.R. 
of this document.  Consistent with section 419(f)(2) of the FD&C Act, proposed § 112.6(b) 174 
 
establishes the modified requirements (label or point of purchase display) applicable to those 
who meet the requirements under § 112.5 for a qualified exemption.   
Specifically, proposed § 112.6(b)(1) w ould require that, when a food packaging label is required 
on food that would otherwise be covered produ ce under the FD&C Act or its implementing 
regulations, you include prominently and conspi cuously on the food pack aging label the name 
and complete business address of the farm  where the produce was grown.  Proposed § 
112.6(b)(2) requires that, when a food packaging label is not  required on food that would 
otherwise be covered produce under the FD&C Act, you prominen tly and conspicuously display, 
at the point of purchase, the name and complete business address of the farm where the produce was grown.  As proposed, the name and address of the farm must be displayed on a label, poster, 
sign, placard, or documents delivered contemporan eously with the produce in the normal course 
of business, or, in the cas e of Internet sales, in an electroni c notice.  That is, if a label is 
otherwise required on the produce th at would otherwise be covered (for example, tomatoes in 
a "clam shell" package) then the label must in clude the name and business address of the farm 
where the produce was grown.  If a label is not  required (for example, unpackaged tomatoes) 
then the name and business address of the farm  where the produce was grown must be displayed 
at the point of purchase (such as  on a poster, for example). Thes e proposed provisions reflect our 
interpretation of section 419(f)(2)(A )(i) and (ii) as applying only to food that would otherwise be 
covered produce but for the qualified exemption.  We  tentatively conclude th at this interpretation 
is reasonable because applying these consumer no tification requirements to food that would not 
otherwise be covered produce would mean a pplying requirements to food that bears no 
relationship to the subject of th is rulemaking (e.g., to milk from a farm that also grows and 
harvests produce and that meets the criteria for the qualified exemption from  this proposed rule). 175 
 
Proposed 112.6(b)(3) states that  the complete business address that you must include in 
accordance with the requirements of paragraph (b )(1) or (2) of this section must include the 
street address or post office box, city, state, and zi p code for domestic farms, and comparable full 
address information for foreign farms.  Pr oposed § 112.6(b)(3) would enable consumers to 
contact the farm where the food that would othe rwise be covered produce was grown (e.g., if the 
consumer identifies or suspects a food safety probl em with a the produce) irrespective of whether 
the produce bears a label.  The us e of the term “business address”  in section 419(f)(2)(A) of the 
FD&C Act contrasts with Congress’ use of a di fferent term, “place of business,” in section 
403(e) of the FD&C Act (21 U.S.C. 343(e)). Sec tion 403(e) provides that foods in package form 
are misbranded unless the product label bear s the name and place of business of the 
manufacturer, packer, or distributor of the food.  Our regulations  interpret “place of business” as 
requiring only the firm’s city, state, and zip code to appear on the product label, as long as the 
firm’s street address is listed in a current telephone di rectory or other city  directory (21 CFR. 
101.5(d)).  We tentatively conclu de 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 othe r required notifications when the farm qualifies 
for the exemption in section 419(f) of the FD&C  Act.  If Congress had considered the less 
complete address already required under section 403(e)(1) of the FD&C Ac t and the “place of 
business” labeling regulation (§ 101. 5(d)) to be adequate for notif ication to consumers for foods 
required to bear labels, there would have b een no need to impose a new, more specific 
requirement in section 419(f)(2)(A)(1) for the fa rm’s “business address” to appear on the food 
label.  Requiring the complete business address for this  purpose is consiste nt with our guidance 
to industry on the labeling of dietary supplem ents as required by the Dietary Supplement and 176 
 
Nonprescription Drug Consumer Protection Act (Ref. 103).  When proposed § 112.5(b) would 
apply to a food for which a food packaging labe l is required under any other provision of the 
FD&C Act, the complete business address would s ubstitute for the “place of business” required 
under section 403(e)(1) of the FD&C Act and 21 CFR 101.5(d) and would not impose any 
requirement for a label that would be in additi on to any label required under any other provision 
of the FD&C Act.  We seek comment on the fe asibility of the labeli ng provisions in proposed 
112.6(b), particularly in the case of consolid ating produce from several farm locations.  
Section 419 of the FD&C Act does not explicitly require farms that meet the criteria for the 
qualified exemption to establish and maintain doc umentation of the basis for their exemption.  
FDA considers that it may be necessary for farm s to maintain such records, and to allow FDA 
access to such records upon request, in order to e fficiently enforce section 419 of the FD&C Act.  
Otherwise we would have no way to determine whether a farm claiming the qualified exemption 
actually met the criteria fo r that exemption.  This could be important, for example, if a farm 
claiming the qualified exemption is directly li nked to a foodborne illn ess outbreak during an 
active investigation or if FDA determines, based on conduct or c onditions associated with the 
farm that are material to the safety of the f ood 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 sec tion V.R. of this document discussing proposed 
subpart R).  Because the withdr awal procedure in proposed subpart R would only apply to farms 
that are eligible for the qualified exemption, we would need to know whether the farm is indeed 
eligible for the exemption in order to select th e appropriate and efficien t enforcement strategy.  
We request comment on whether we should requir e farms to be able to provide adequate 
documentation, as needed, to demonstrate the basi s for the qualified exemption.  Specifically, we 177 
 
request comment on whether we should do this by requiring records to be established and 
maintained in accordance with the requirements of proposed subpart O, or if there is an 
alternative strategy by which we could require rete ntion of and access to such records (such as by 
requiring farms only to retain reco rds kept in the normal course of their business bearing on the 
criteria for the qualified exemption that they use to determine their eligibility and requiring FDA 
access to such records upon request). 
 
B. Subpart B – General Requirements 
As proposed, subpart B discusses th e general requirements  applicable to pers ons who are subject 
to this part and alternatives from the require ments established in this  part that would be 
permitted, under specified conditions. 
1. Comments Relevant to Proposed Provisions 
We received several comments in response to th e 2010 FR notice that addressed issues relevant 
to the general requirements established in this  subpart of the rule.  A consumer organization 
urged FDA to take additional step s to ensure the safety of bagge d salads and all leafy greens.  
Some comments recommended that FDA include in this rule an amendment mechanism that can 
expeditiously accommodate new scientific knowledge. 
Section 402 of the FD&C Act specifies conditions under which a food is deemed 
adulterated, including if the food bears or contains any added poi sonous or deleterious substance 
which may render it injurious to health (402(a)(1));  if it is unfit for food ( 402(a)(3)); or  if it has 
been prepared, packed, or held under insan itary conditions whereby it may have become 
contaminated with filth, or whereby it may have b een rendered injurious to health (402(a)(4)).  In 
proposed § 112.11, we would specifically require that  covered farms take appropriate measures 178 
 
to minimize the risk of serious adverse health co nsequences or death from the use of, or exposure 
to, covered produce, including th ose measures reasonably necessa ry to prevent the introduction 
of known or reasonably foreseeable hazards in to covered produce as well as to provide 
reasonable assurances that the produce is not ad ulterated under section 402 of the FD&C Act on 
account of such hazards.  Such hazards would include  all pathogens to the extent that they pose a 
risk of serious adverse health cons equences or death, including Salmonella  and E. coli  O157:H7, 
in all covered produce raw agricultural commodities, including leafy greens.  With respect to bagged salads, we note that such salads are manufactur ed in facilities that are required to register 
with us and, therefore, would be covered under section 418 of the FD&C Act and any regulations 
promulgated pursuant to that authority, ra ther than by this proposed rulemaking.  
We recognize the value in making this re gulation flexible, where appropriate, to 
accommodate future changes in science and technology.  In proposed § 112.12, we list the 
specific requirements established in this rule  for which we believe alternatives may be 
appropriate and the circumstances under which su ch alternatives could be used.  In addition, 
consistent with section 419(c)(2 ) of the FD&C Act, in proposed subpart P, we provide for a 
mechanism by which a State or a foreign countr y from which food is imported into the United 
States may request a variance from one or more  requirements proposed in this part, where the 
State or foreign country determines that: (a) the variance is necessary in light of local growing 
conditions; and (b) the procedures, processes, and practices to be  followed under the variance are 
reasonably likely to ensure that the produce is  not adulterated under S ection 402 of the Act and 
to provide the same level of public health protecti on as the requirements of this part (see section 
V.P. of this document).  We also intend to publ ish guidance, as appropr iate, to provide updates 
on current thinking with respect to be st practices in produce safety.   179 
 
2. Proposed Requirements 
a. General Requirements Applicable to Persons Subject to this Part 
As proposed, § 112.11 establishes the general requirem ents applicable to persons who are subject 
to this rule.  Proposed § 112.11 requi res that you take appropriate measures to minimize the risk 
of serious adverse health consequences or death from the use of, or exposure to, covered 
produce, including those measures  reasonably necessary to prev ent the introduction of known or 
reasonably foreseeable hazards into covered produ ce, and to provide reasonable assurances that 
the produce is not adulterated und er section 402 of the FD&C Act on account of such hazards.  
This provision is consistent w ith the requirements of section 419(c)(1)(a) of the FD&C Act, 
which mandates, in relevant part, that we publis h regulations that “set forth those procedures, 
processes, and practices that th e Secretary determines to minimi ze the risk of serious adverse 
health consequences or death, in cluding procedures, processes, a nd practices that the Secretary 
determines to be reasonably necessary to prevent the introduction of known or reasonably 
foreseeable biological, chemical, and physical ha zards, including hazards that occur naturally, 
may be unintentionally introduced, … into fruits and vegetables, . . . and to provide reasonable 
assurances that the produce is no t adulterated under sec tion 402.”  As discussed in section IV.B. 
of this document, we have tentatively concluded that this rule should focus solely on biological 
hazards. In subparts C to O, we propose science-base d minimum standards related to the growing, 
harvesting, packing, and holding of covered produ ce that we believe are necessary to minimize 
the risk of serious adverse health conseque nces or death by preventing the introduction of 
hazards and providing reasonable assurances th at the covered produce is not adulterated.  
Proposed § 112.11 would require, for example,  that wh enever a standard specified in this part is 180 
 
not met, you would take those steps reasonably n ecessary to identify and evaluate the cause of 
the problem and ensure that it is  rectified.  Accurate identification of the cause of the failure is 
critical to the success of any pot ential corrective actions.  For example, if your employees are 
having difficulty identifying covered produce th at should not be harv ested due to potential 
contamination, you might initially th ink the answer is to provide mo re frequent training; however 
upon investigation, you may discover that the actual  cause of the problem is that your employee 
training program is providing inaccurate informati on.  In this case, to correct the problem, you 
would need to fix your training program.  Promp tly taking such follow-up actions once the cause 
of the problem has been identifie d is necessary to minimize the ri sk of serious adverse health 
consequences or death from the use of, or e xposure to, your covered produce and to provide 
reasonable assurances that the product is not adu lterated under section 402 of the FD&C Act.   
In addition, proposed § 112.11 would require you to take appropriate measures to minimize risks 
of serious adverse health consequences or deat h from the use of, or exposure to, covered produce 
that may arise unexpectedly and therefore not be reflected in a specific standard set forth in 
proposed subparts C to O of this rule.  For example,  in the event of an unexpected event, such as 
receipt of information suggesting that your covered produce from a pa rticular field is adulterated 
because it bears or contains a pathogen that ma y render the produce injurious to health, proposed 
§ 112.11 would require you to take a ppropriate measures to minimize the risk of serious adverse 
health consequences or death from the us e of, or exposure to, your covered produce by 
preventing the introduction of biological hazards  into or onto your produce or by taking 
measures to provide reasonable assurances that  the produce is not adul terated under section 402 
of the FD&C Act.  Such measures might include, for example, conducting a root cause 
investigation to try to determine the source of the contamin ation, making appropriate changes to 181 
 
your conditions and practices suggested by the ro ot cause investigation, including to produce in 
other fields, as appropriate, determ ining the extent of the impact of  the root cause (i.e., within the 
suspect field and in other fiel ds), and excluding adulterated pr oduce from commerce.  We note, 
however, that we do not intend for proposed § 1 12.11 to suggest that you would need to take 
measures to exclude animals from outdoor growi ng areas, to destroy anim al habitats near your 
outdoor growing areas, to clear fa rm borders around outdoor growing areas or drainages, or to 
take any action that would violate appli cable environmental laws or regulations. 
We propose to include proposed § 112.11 in orde r to account for the variety of possible 
circumstances that might arise in which an unexpected circumstance or unique farm 
characteristics would justify prev entive measures to prevent in troduction of hazards or provide 
assurances against adulteration in order to minimize the risk of serious adverse health 
consequences or death.  We request comment on this approa ch, and on whether we should 
instead establish specific standards for any types of hazards that would be covered in proposed § 
112.11 but for which we have not proposed specific  standards in proposed subparts C through O.  
b. Alternatives to Certain Requirements As proposed, § 112.12 allows for the us e of alternatives to certain requirements of this part.  
Subparagraph (a) lists the speci fic requirements for which alternatives may be considered 
provided you are in compliance with subparagraphs  (b) and (c), which describe the conditions 
for use of an alternative.  Proposed § 112.12(b)  states that you may establish and use an 
alternative to any of the requi rements listed in paragraph (a),  provided you have adequate 
scientific data or information to support a conc lusion that the alternative would provide the same 
level of public health protection as  the applicable requirement esta blished in this part (including 
meeting the same microbiological standards, where applicable) and would not increase the 182 
 
likelihood that your covered produce will be adulte rated under section 402 of the FD&C Act, in 
light of your covered produce, practices, and conditions, including agro-ecological conditions 
and application interval.  We do not propose to require you to submit such scientific data or 
information to us for review or approval prior to marketing.  However, we would require that 
you maintain a record of any su ch scientific data or inform ation, including any analytical 
information, and make such data and informati on available to us to evaluate upon request.  
Proposed § 112.12(c) clarifies that  the scientific data and in formation used to support an 
alternative to a requirement may be developed by  you, available in the scientific literature, or 
available to you through a third pa rty, and further provides that documentation of such data and 
information must be established and maintained in accordance with the requirements of subpart 
O of this part.  As discussed in section II.E .4. of this document, FDA is collaborating with 
partners on research that may pr ovide scientific support for specif ic alternatives to certain of 
these requirements.  FDA intends to issue guidance on specific alternatives that it may identify as 
meeting the requirements of the rule in order to a ssist farms in complying with the final rule.  For 
example, a farm that applies crop protection sp rays to the harvestable portion of crops (i.e., 
application of water containing crop protection substances usi ng a direct water application 
method) several days before the crop is harves ted using a water source that does not meet the 
requirements of § 112.44(c) (i.e, EPA generic E. coli  “recreational water” standard), may use an 
alternative measure provided by th eir Cooperative Extension agent,  for example, as long as the 
measure is based on scientifically sound data and meets the conditions described above (i.e., 
provides the same level of public health protec tion as the applicable requirement and does not 
increase the likelihood that cove red produce will be adulterated) .  For example, the study might 
demonstrate that the quality of water used fo r direct application method irrigation is not 183 
 
important as long as there are at least two days be tween application and harvest, or that water of 
some lesser standard than that in § 112.44(c) could safely be applied immedi ately before harvest.  
The farm operator would maintain a copy of  the information provided by the agent as 
documentation that the alternat ive measure was based on sound science.  When FDA becomes 
aware of such information, it is ou r intention to include it in guidance, so that farm operators can 
also rely on FDA guidance for such alternative measures. 
As proposed in § 112.12(a), you may establish alte rnatives to the following requirements: 
(1) the requirements in § 112.44(c), for testing wa ter, and taking action ba sed on test results, 
when agricultural water is used during growi ng operations for covered produce (other than 
sprouts) using a direct water application method; 
(2) the composting treatment processes required in § 112.54(c)(1) and (2);   
(3) the minimum application interval establishe d in § 112.56(a)(1)(i) for an untreated biological 
soil amendment of animal origin; and 
(4) the minimum application interval establ ished in § 112.56(a)(4)(i) for a biological soil 
amendment of animal origin tr eated by a composting process.  
Under proposed § 112.12(a)(1), you may establish an alternative to the requirements, established 
in proposed § 112.44(c) for testing water, a nd taking action based on test results when 
agricultural water is used during growing operati ons for covered produce (other than sprouts) 
using a direct water application method.  Under proposed § 112.44(c), you must test the quality 
of water you use during growing activities for covered produce (other than sprouts) in 
accordance with one of the appropr iate analytical methods in pr oposed subpart N.  If you find 
that there is more than 235 CFU (or MPN, as appropriate) generic E. coli per 100 ml for any 
single sample or a rolling geometric mean (n=5) of more than 126 CFU (o r MPN, as appropriate) 184 
 
per 100 ml of water, you must immediately disconti nue use of that source of agricultural water 
and/or its distribution system fo r the uses described in that paragraph and before you may use the 
water source and/or its distribu tion system again for those uses, you must either: (1) re-inspect 
the entire agricultural water system under your control, iden tify any conditions that are 
reasonably likely to introduce known or reasonab ly foreseeable hazards into or onto covered 
produce or food-contact surfaces, make necessary ch anges, and retest the water to determine if 
your changes were effective, or (2) treat the water in accordance with the requirements of § 
112.43.  As discussed in section V.E. of this document, we considered  several factors and 
ultimately determined that the microbial standard in proposed § 112.44(c), which is based on certain aspects of U.S. EPA’s recreational wate r standards is appropriate for the uses of 
agricultural water covered by proposed § 112.44(c).  We seek comment on this approach. 
However, we acknowledge that in specific circumst ances an alternative sta ndard (e.g., a standard 
that applies an application interval (time betw een application and harvest) in place of the 
112.44(c) water standard, but is limited to a spec ific commodity or comm odity group and region) 
may be appropriate if the alternative standard is shown to provide the same  level of public health 
protection as the standard in proposed § 112.44(c)  and not to increase the likelihood that the 
covered produce will be adulterated.  For example, we are working with USDA and other stakeholders to facilitate research into app lication intervals that would be commodity- and 
region-specific, such that water not meeting the proposed § 112.44(c) standard could be used in a 
direct water application method fo r growing covered produce other than sprouts as long as it was 
applied before the start of the scientifically established application interval (i.e., at a certain number of days before harvest or earlier).  Ther efore, we tentatively conc lude that it would be 
appropriate to allow for alternatives to  the requirements in proposed § 112.44(c). 185 
 
Under proposed § 112.12(a)(2), you ma y establish an alternative to the treatment processes, 
established in proposed § 112.54(c)(1) and (2),  for composting, provided you comply with § 
112.54(c)(3).  The processes esta blished in § 112.54(c )(1) and (2) as scie ntifically valid 
controlled composting processes de monstrated to satisfy the mi crobial standard in § 112.55(b) 
for Salmonella and for fecal coliforms are: (1) Static composting that maintains aerobic (i.e., 
oxygenated) conditions at a minimum of 131°F (55 °C) for 3 days and is followed by adequate 
curing, which includes proper insu lation; and (2) Turned compos ting that maintains aerobic 
conditions at a minimum of 131°F (55 °C) for 15 da ys, with a minimum of five turnings, and is 
followed by adequate curing, which includes proper insulation.  We tentat ively conclude that it 
would be appropriate to allow fo r the use of other static or tu rned composting protocols that 
maintain conditions for a combination of temper atures and time other than the temperature and 
times specified in proposed §§ 112.54(c)(1) and (2),  and is followed by adequate curing, which 
includes proper insulation, if th ey achieve the same level of pathogen reduc tion (i.e., meet the 
microbial standard in § 112.55(b)).  In this se nse, the microbial standards would provide a 
performance standard; practices that meet this objective measure would be acceptable.  It would 
be your responsibility to consider the moisture content, pH, carbon to nitrogen ratio (C:N), 
feedstock, and any other appropr iate consideration needed du ring composting to adequately 
achieve the microbial standa rds of proposed § 112.55(b). 
Under proposed § 112.12(a)(3), you ma y establish an alternative to the minimum application 
interval of nine (9) months, established in pr oposed § 112.56(a)(1)(i), for an untreated biological 
soil amendment of animal origin that is reason ably likely to contac t covered produce after 
application or for a compost agricultural tea that contains compost agricultural tea additives.  As 
discussed in section V.F of this document, we  have tentatively conc luded that, under certain 186 
 
circumstances, the application interval in § 112.56( a)(1)(i) may be more than what is necessary 
for minimizing the likelihood that covered produce that is grown in soils amended with an 
untreated biological soil amendment, and is reasonabl y likely to contact the soil after application, 
pose to the public health.  Th ese circumstances could include differences in likelihood of 
contamination posed by the specific feedst ock, application method or treatment method, 
especially given the potential for new innovations in such methods.   Under proposed § 112.12(a)(4), you ma y establish an alternative to the minimum application 
interval of 45 days, established in proposed § 112.56(a)(4)(i), for a biolog ical soil amendment of 
animal origin treated by a composting process in  accordance with the requirements of proposed § 
112.54(c) that satisfies the micr obial standard in proposed § 112.55(b), and that is reasonably 
likely to contact covered produce af ter application.   As discus sed in section V.F. of this 
document, we are proposing a multiple-hurdle approach to minimizing the likelihood of 
contamination by addition of an a pplication interval of 45 days to any biological soil amendment 
of animal origin treated by composting that is reasonably likely to cont act covered produce after 
application. This time period has been shown to be effective when the population of the pathogen 
is minimal 
(Ref. 104) as can be expected of a fully co mposted biological soil amendment of 
animal origin. This multiple hurdle approach and time interval has also been utilized in current 
industry standards for leafy greens (Ref. 31).  We seek comments on this proposal. We have also 
tentatively concluded that, unde r certain circumstances, the application interval in § 
112.56(a)(4)(i) may be more than what is necessary for minimizing the likelihood of contamination of covered produce that is grown in  soils amended with a treated biological soil 
amendment, and that is reasonably likely to  contact the soil after application.  These 
circumstances could include differences in lik elihood of contamination posed by the specific 187 
 
feedstock, application method or  treatment method, especially given the potential for new 
innovations in such methods.   As noted above, in any use of alternatives permitted in § 112.12(a)(1) through § 112.12(a)(4), in 
accordance with proposed § 112.12(b), you would be requi red to have adequate scientific data or 
information to support a conclusion that the alte rnative would provide the same level of public 
health protection as the requirement specified in the proposed rule and would not increase the 
likelihood that your covered produce will be adul terated under section 402 of the FD&C Act.  
Further, in accordance with proposed § 112.12(c), you must establish and maintain 
documentation of such scientific data or info rmation, which may be developed by you, available 
in the scientific literature, or available to you through a third party.  We are working with USDA 
and other stakeholders to conduct research on relevant alternative practices and intend to make 
the results of that research av ailable in the future.  We s eek comment on whether we should 
require you to notify FDA of your conclusion to esta blish or use an altern ative that is permitted 
under §§ 112.12(a)(1) through (a)(4), and whether we should require you to submit relevant 
scientific data or info rmation to FDA as part of such a notification.  
 C.  Subpart C – Standards Directed to  Personnel Qualifications and Training 
As proposed, subpart C discusses minimum standa rds directed to personnel qualifications and 
training that are reasonably necessary to minimize the risk of serious adverse health consequences or death from the use of, or exposure to, covered produce, including those 
reasonably necessary to prevent the introduction of known or reasona bly 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.  188 
 
1. Comments Related to  Proposed Provisions 
We received several comments in response to th e 2010 FR notice that addressed issues relevant 
to personnel qualifications and training. Severa l comments expressed concern over language and 
educational barriers greatly impeding the farm’s ability to effectively fulfill the training 
requirements for their field workers.  They also  stressed the need for far reaching, accurate, 
consistent, and well-rounded training programs with skilled trainers providing the same 
information to growers, processors and distri butors. Comments further suggested that training 
materials should have addendums to reflect the differences among the varied growing regions, 
commodities, and production practices and processes, as well as train-the-trainer programs for individuals responsible for training farm work ers.  Many firms also urged organizations, 
universities, and extension agencies to share ex periences and to provide resources for worker 
training.  Several comments pointed out difficulties in training due to the transient or short term 
nature of farm workers and due to the seasona l relocation of their ope rations.  In addition, 
comments expressed concern over the cost of implementation, including regular refresher 
courses and training materials, a nd the reliability of third-party training materials. One comment 
requested that individuals responsible for the tr aining program and materials should ensure that 
curricula are updated to reflect a ny new scientific information.   
 We believe that adequate a nd appropriate training of personne l who handle covered produce or 
food-contact surfaces, or who are engaged in the s upervision thereof, is an essential component 
of standards for produce safety.  Regardless of th e nature of the farm workers, we propose that 
they must receive training upon hiring, at th e beginning of each growing season, and with 
periodic updates as necessary in order to prevent contamination of covered produce.  Farm workers need to know how to recognize potenti al contamination problems (e.g., a leafy green 189 
 
vegetable contaminated with manure) and to be tr ained to know what to do when those situations 
present themselves.  The farm worker is a ke y component in the food chain for ensuring the 
safety of covered produce.  No matter the transient nature, any worker can be a potential pathway 
for contamination of produce during growing, ha rvesting, packing, and holding (e.g., because of 
hygiene issues or illness) or fail to identify a situation that may result in contamination of the 
covered produce being grown, harvested, packed, or  held if they are no t cognizant of proper food 
safety procedures and standards.  It is not uncommon for workers to change based on season and 
location and, therefore, proposed § 112.21(a) would require personnel to receive training upon 
hiring and at the beginning of each growing seas on (if applicable).  Proposed § 112.21(a) would 
also require that pers onnel receive periodic updates as a wa y of reminding them of the proper 
procedures including any changes in those proce dures. Such updates may not require full training 
sessions, but only short descriptiv e sessions to ensure that all personnel remain aware of all 
procedures necessary to mainta in the safety of produce.  
Together with the USDA, Cornell University’s National GAPs program, the Association of Food 
and Drug Officials (AFDO), and th e National Association of Stat e Departments of Agriculture 
(NASDA), we have formed the Produce Safety  Alliance (PSA), whic h is a public-private 
partnership established to provi de educational outreach assistance to fresh produce growers and 
packers.  This program is in the process of crea ting training materials that  will be both region- 
and commodity-specific.  We expect these materials to be standardized, multi-formatted, and multi-lingual, and available in pictorial format to  help overcome literacy issues.  Specific focus 
areas for the PSA include GAPs and co-managem ent education and outreach efforts for produce 
farmers and packers, with special emphasis on sm all-scale operations.  This alliance will also 
include a train-the-trainer lesson plan and an e ducation outreach program delivery for farmers, 190 
 
trainers, and regulators.  We intend to explore the need for additional such partnerships, as 
appropriate, to address any commodity-specific needs for outreach and assistance. We welcome 
comments and suggestions for training development strategies.  
2. Proposed Requirements 
Proposed § 112.21 would establish requirements for the qualifications and training for personnel 
who handle (contact) covered pr oduce or food-contact surfaces, or who are engaged in the 
supervision thereof. Having personnel follow proper food hygiene practices, including personal 
health and hygiene, can reduce the potential fo r on-farm contamination of covered produce.  
Educating personnel who conduct co vered activities in which they  contact covered produce and 
supervisors about food hygiene, food safety, and the risks to produce safety associated with 
illnesses and inadequate personal hygiene is a s imple step that can be taken to reduce the 
likelihood of pathogens being spread from or by personnel to covered produce.   
Most current FDA, private and internationa l guidelines for the pr oduce industry include 
provisions related to training f ood handlers in the importance of personal health and hygiene to 
food safety (Ref. 10.Ref. 20.Ref. 50.Ref. 48.Ref. 96.Ref. 26).  As described in the QAR, FDA’s 
follow-up farm investigations in response to out breaks and contamination events identified poor 
worker health and hygiene, unsafe produce handli ng and storage practices, and specifically poor 
training in these areas, as likely contributing factor s to these events.  This information reinforces 
the importance of training farm personnel, incl uding supervisors, in food hygiene, food safety, 
employee health and personal hygiene.   Proposed § 112.21(a) would require that all personnel (including te mporary, part time, seasonal 
and contracted personnel) who handle (contact) covered produce or food-contact surfaces and 
their supervisors receive training that is appropriate to the pe rson’s duties, upon hiring, at the 191 
 
beginning of each growing season (if applicable), and periodically thereaf ter.  Because ensuring 
that covered produce is not contaminated is de pendent on personnel follow ing proper food safety 
and hygiene practices, all personnel who contac t covered produce and food-contact surfaces 
must receive training when hired, before they pa rticipate in the growing, harvest, packing or 
holding of covered produce in which they contact  covered produce, and must be periodically 
reminded about the need to follow these practices through refresher training.  When a farm hires 
workers after the beginning of a growing season, these workers would need to be trained upon 
hiring.  Because the farm does not employ these wo rkers at the beginning of the first growing 
season, the requirement for training at the be ginning of each growing season would not be 
applicable to those workers unt il the beginning of the next grow ing season, if they are still 
employed by the farm at that time.  Manage rs and supervisors must have the necessary 
knowledge of food safety and hygiene principles and practices to be able to  assess whether their 
staff are following appropriate practices, a nd take the necessary action to remedy any 
deficiencies, which could include on-t he-spot training for their staff.   
Periodic refresher training for all relevant pers onnel, including managers and supervisors, is 
necessary to ensure continual aw areness of important food safety and hygiene principles.  It is 
also important when new information is ava ilable about practices th at may contribute to 
foodborne illness or when, for that reason or other reasons, changes in the farm’s procedures are 
put in place.  For example, during the past de cade several segments of the produce industry 
reviewed and revised their indus try guidelines or developed ne w guidelines to address current 
food safety concerns relative their specific comm odity (i.e., lettuce, tomatoes, sprouts, and 
cilantro).   192 
 
Proposed § 112.21(b) would require that all personnel (including te mporary, part time, seasonal 
and contracted personnel) who handle (contact) covered produce or food-contact surfaces and 
their supervisors  have the trai ning, in combination with educati on or experience, to perform the 
person’s assigned duties in a manner that ensu res compliance with this part.  Proposed § 
112.21(b) would provide flexibility for how pe rsonnel become qualified to perform their 
assigned duties by recognizing multiple pathways to obtain the necessary qualifications: training 
(such as training provided on-the-job), in combin ation with education, or experience (e.g., work 
experience related to an employee’s current as signed duties).  The standards in subparts C 
through O often involve action by farm pers onnel (e.g., monitoring of animal intrusion, 
inspecting agricultural water syst em) that require specific knowle dge, skills and abilities, without 
which the standard could not be properly ac hieved.  Proposed § 112.21(b)  requires that those 
farm personnel have the training so that they will have the necessary knowledge, skills, and 
abilities to perform their duties. 
Proposed § 112.21(c) would establish requirements for training to be  conducted in a manner that 
is easily understood by personnel being trained.  Th e goals of training cannot  be achieved if the 
person receiving the training ca nnot understand it.  Training c ould be understood by personnel 
being trained if, for example, it was conducted in  the language that employees customarily speak 
and at the appropriate level of education.  In some cases in may be necessary to use easily 
understood pictorials or graphi cs of important concepts (Ref. 105).   
Proposed § 112.21(d) would establish requirements for training to be repeated as necessary and 
appropriate in light of observat ions or information indicating th at personnel are not adequately 
meeting standards established by FDA in subparts C through O of the rule.  The goals of training 
are not achieved if the persons receiving the training do not correc tly implement those standards 193 
 
taught.  Moreover, repeated trai ning as proposed in § 112.21(d) is  necessary when an employee 
that does not follow the correct food safety prot ocol, because such behavior may increase the 
likelihood of introducing a food safety hazard to covered produce.  When an employee requires 
additional training, it may consist of informal on-th e-spot instruction to focus on those measures 
not being adequately implemented as opposed to more comprehensive training.  For example, if 
you observe an employee commit a minor error, su ch as an inappropriate method for recording 
monitoring information in a log, an appropriate ac tion could be to show the employee the correct 
method of recording the information and contra st this with the inappropriate method the 
employee had been using.  However, if an employ ee displays repeated mistakes or a fundamental 
misunderstanding of the correct procedures for handling covered produce, an appropriate action 
may be to have the employee repeat relevant training, or to attend a comprehensive training 
course.  If you conclude that the employee may not have the skills to conduct certain covered 
activities, an appropriate action may be to trai n the employee for new re sponsibilities that are 
more suitable to his or her skills.   
Proposed § 112.22(a) would require that, at a minimum, all personnel who handle (contact) 
covered produce during covered activities mu st receive training that would include: (1) 
principles of food hygiene and food safety (p roposed § 112.22(a)(1)); (2 ) the importance of 
health and personal hygiene for all personnel and visitors, including recognizing symptoms of a 
health condition that is reasonabl y likely to result in contamin ation of covered produce or food-
contact surfaces with microorganisms of public  health significance (proposed § 112.22(a)(2)); 
and (3) the standards as applic able to the employee’s job res ponsibilities, including those 
established by FDA in subparts C through O of  this part (proposed § 112.22(a)(3)).   194 
 
We tentatively conclude that the broad topic areas addressed in proposed § 112.22(a) are those 
minimum topic areas necessary to be covered during training for all employees who handle 
(contact) covered produce.  Trai ning in the principles of food hygiene and food safety are 
necessary to provide an overall framework for job performance.  Training in health, hygiene, and 
disease control can teach workers how to mini mize the likelihood of transferring pathogens to 
covered produce.  These topics are covered in several currently used guidance documents (Ref. 
10.Ref. 20.Ref. 50.Ref. 48.Ref. 96).  In addition, training in the sp ecific standards established in 
subparts C through O of this part which are necessary for the employee to use during the course of their duties will increase the likelihood that those standards w ill be implemented correctly and 
effectively.  We seek comments on the scope, fr equency, and methods outlined in the proposed 
training sections of the proposed rule.  Proposed § 112.22(b) would require that persons  who conduct covered harvest activities for 
covered produce also receive trai ning that includes all of the following: (1) recognizing covered 
produce that should not be harveste d, including covered produce th at may be contaminated with 
known or reasonably foreseeable food safety ha zards  (proposed § 112.22(b)(1)); (2) inspecting 
harvest containers and equipment to ensure that they are functioni ng properly, clean, and 
maintained so as not to become a source of c ontamination of covered produce with known or 
reasonably foreseeable food safety hazards  (proposed § 112.22(b)(2)); and (3) correcting 
problems with harvest containers or equipment, or reporting such problems to the supervisor (or 
other responsible party), as appropriate to the person’s j ob responsibilities (proposed § 
112.23(b)(3)). We tentatively conclude that the topic areas a ddressed in proposed § 112.22(b), in addition to § 
112.22(a), are those minimum topic areas necessary  to be covered during training for persons 195 
 
who conduct harvest activities.  Harvest workers need to learn how to recognize produce that 
should not be harvested (such as rotten or decayed fruit, “drops,” or harvestable items that have 
been contaminated with feces), because not harv esting such covered produce would be the first 
opportunity to prevent that produc e from entering commerce, and as a practical matter may be 
the only such opportunity (for example, during a fi eld-pack operation with no subsequent culling 
stage).  Proposed § 112.112 would require that farm s take all measures reasonably necessary to 
identify and not harvest covered produce that is  visibly contaminated with animal excreta.  
Harvest workers must be trained to both recogn ize this condition and to avoid harvesting covered 
produce that exhibits the condition.  Harvest work ers also need to know how to inspect harvest 
containers and equipment to ensure that they are functioning properly, cl ean, and maintained so 
that they will not act as a source of contamin ation or lead to dama ge of covered produce 
(damaged produce is more likely to harbor pat hogens, and at a greater population, than is sound 
produce (Ref. 59.Ref. 106)).   Harvest workers also need to know how to correct  problems with 
harvest equipment or containers when they encounter them, or n eed to know that they should 
report such problems to someone who would be responsible for ensuring that the problem is 
corrected.  These topics are covered in se veral currently used relevant documents (Ref. 8.Ref. 
33.Ref. 18.Ref. 89.Ref. 84).  We acknowledge the challenge th ese training requirements may pose 
to farms that employ contracted harvest crews.  In such cases, we expect that the harvest crew 
company could provide the required training to wo rkers, who move from farm to farm under the 
employment of the harvest crew company.  Fa rms on which such harvest crews work could 
request certification from the harvest crew co mpany that their workers have received the 
required training.  We seek comment on the feas ibility of the proposed training requirements, 
particularly with respect to harvest activities.  196 
 
Proposed § 112.22(c) would require that at least one supervisor or responsible party for your 
farm successfully complete food safety training at least equivalent to  that received under 
standardized curriculum recognized as ade quate by the Food and Drug Administration. 
Experience at farming does not necessarily convey  knowledge of food safety, particularly that of 
microbial food safety hazards, and therefore specialized training is needed to address the specific 
concerns of on-farm food safety. The purpose of training a supervisor or other responsible party 
is so that person can help train other empl oyees, recognize conditions that could lead to 
contamination of covered produce, and take action to co rrect those conditions.  As discussed in 
section II.D. of this document, FDA has, together with USDA AMS, established the jointly funded PSA, a public-private partnership that will  develop and disseminate science- and risk-
based training and education programs to provide produce growers and packers with 
fundamental, on-farm food safety  knowledge, starting in advance of this proposed rule and 
continuing after the final regulati on is promulgated.  A first phase of PSA’s work is intended to 
assist growers, especially small growers, in esta blishing food safety programs consistent with the 
GAPs Guide and other existing guidances and require ments so that they will be better positioned 
to comply with a final produce rule.  As this rulemaking progresses, FDA will work to ensure that the PSA materials are modifi ed, as needed, to be consistent  with the requirements of this 
rule.  Included in that material will be the standardized curriculum against which FDA intends to compare other training programs.  After reviewing the final draft of the PSA training materials, 
FDA intends to publish a notice of availability  of the documents in the Federal Register
. We 
would encourage trainers outside the PSA to evaluate their course s, past, present, and future, 
against the PSA materials when they become ava ilable and to modify or adapt curricula, where 
necessary, to ensure that they are consistent w ith, and provide at least an equivalent level of 197 
 
instruction to, the Alliance course . We have no plans to publish a list of "approved'' courses other 
than the Alliance course materials.  Proposed § 112.23 would require that you assign or identify 
personnel to supervise (o r otherwise be responsible for) your  operations to ensure compliance 
with the requirements of the rule.  Oversight by a qualified individual is essential to the effective 
implementation of the rule.  Under proposed § 112.23, the personnel that you assign or identify 
to supervise (or otherw ise be responsible for) your operations  may be a single person (including 
yourself), or may be a team of individuals, each with specific  areas of responsibility (e.g., you 
may assign or identify separate persons to be re sponsible for your water distribution system, your 
harvest activities, your san itary accommodations, and your packing activities).   
Proposed § 112.30(a) would require that you establis h and keep records required under subpart C 
in accordance with the requirements of subpa rt O of the rule.  Proposed § 112.30(b) would 
require that you establish and keep records th at document required training of personnel, 
including the date of the traini ng, the topics covered, and the pe rson(s) trained. An example of 
records that would comply with proposed § 112.30(b) is an attendance sheet with the date, list of 
those in attendance, and the par ticular topics covered (such as  proper hand washing or how to 
collect samples for water testing).  The reco rds required by proposed § 112.30(b) would enable 
you to track the training personnel receive, th ereby enabling you to identify personnel and 
training topics for periodic updates and personne l that have the prerequisite training for 
assignment to certain responsibilities.  Such r ecords would enable you to document that a person 
has, as would be required under proposed §§ 112.21( a) and (b), successfully completed training 
as appropriate to the person’s duties, upon hiring and periodically thereaf ter, including the 
principles of food hygiene and food safety and al so the training that would be specific to a 
person’s tasks and responsibilities. 198 
 
 
D.  Subpart D – Standards Directed to Health and Hygiene 
As proposed, subpart D discusses science-based minimum standards directed to health and 
hygiene that are reasonably necessary to mini mize 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 assu rances that the produce is not adulterated under 
section 402 of the FD&C Act. 
1. Comments Relevant to  Proposed Provisions  
We received some comments in response to the 20 10 FR notice that addresse d issues relevant to 
health and hygiene. Several comments noted the challenges of enforcing use of gloves and clean 
clothes.  Others expressed con cerns related to identifying sick employees who could contaminate 
covered produce or food-contact surfaces, wh ile another comment asked about potential 
requirements on hygienic practices and questio ned whether hand jewelr y could contaminate 
produce such as leafy greens.    We recognize the importance of taking appropriate measures to prevent sick or infected persons 
from contaminating covered produce or food-cont act surfaces.  In prop osed § 112.22(a)(2), we 
propose to require training of pe rsonnel to recognize symptoms of  a health condition that is 
reasonably likely to result in contamination of  covered produce or food- contact surfaces with 
microorganisms of public health significance.  The proposed requi rements for standards directed 
to health and hygiene focus on ma intaining adequate personal clea nliness.  Gloves can provide a 
barrier to reduce the potential for contamination; however, gl oves themselves can transfer 
pathogens to covered produce if they become contaminated.  Therefore, while we are not 199 
 
proposing to require the use of gloves, we are pro posing to require the proper use of gloves when 
workers wear them (proposed § 112.32(b)(4)).  Clothe s should be adequately clean if by virtue of 
type of operation the workers are performing, the clothes could potentially contaminate covered 
produce with pathogens.  
2.  Proposed Requirements 
Proposed subpart D would require th at you take those measures that we tentatively conclude are 
reasonably necessary to prevent personnel and vi sitors from introducing known or reasonably 
foreseeable hazards into or onto covered produce or food-contact surfaces.  As discussed above 
(see sections I.A. of this document, and QAR),  people can carry a wide variety of pathogens 
(including hepatitis A virus, Salmonella , E. coli  O157:H7, Shigella , Cyclospora , and 
Cryptosporidium  (Ref. 93)(Ref. 107).  Bacteria, viruses, and parasites are frequently transmitted 
from person to person and from person to f ood, particularly through the fecal-oral route (Ref. 
95.Ref. 96.Ref. 97.Ref. 98.Ref. 93). Several of the provisions of pr oposed subpart D are similar to 
requirements in our Current Good Manufacturing Practice regulations fo r food and for dietary 
supplements (§ 110.10 and 111.10, respectively), and to provisions in our GAPs Guide (Ref. 10), 
the AFDO Model Code (Ref. 20), various produce industry guidelines (Ref. 46.Ref. 44), a 
marketing agreement (Ref. 31), and international guidelines (Ref. 96).  
Proposed § 112.31 would require that you take measur es necessary to prev ent ill or infected 
persons from contaminating covered produce with microorganisms of public health significance. 
Proposed § 112.31(a) would require th at you take measures to prev ent contamination of covered 
produce and food-contact surfaces with microorgani sms of public health significance from any 
person with an applicable health condition (suc h as communicable illnesses that present a public 
health risk in the context of normal work duties, infection, open lesion, vomiting, or diarrhea).   200 
 
Proposed § 112.31(b)(1) would require that you exclude any person from working in any 
operations that may result in contamination of covered produce or food-c ontact surfaces with 
microorganisms of public health  significance when the person (by medical examination, the 
person’s acknowledgement, or observa tion (for example, by a supervis or or responsible party)) is 
shown to have, or appears to have, an applic able health condition, unt il the person’s health 
condition no longer presents a risk to public he alth.  Applicable health conditions would not 
include non-communicable diseases such as can cer, diabetes, or high blood pressure, or non-
communicable conditions such as pregnanc y, which would not present a likelihood of 
contamination to covered produce or food contact surfaces.  For example, if an employee tells 
you that his or her physician has diagnosed that  the employee has a fever, and the employee 
normally handles your covered produce, you must take steps to ensure that the employee does 
not come into contact with your covered pr oduce because the fever may suggest that the 
employee has an infection and ther e is a reasonable possibility of contamination. Likewise, if 
you see that an employee has an open wound or  sore, and the employee normally handles 
covered produce, you must take steps to ensure th at he or she is excluded from handling covered 
produce if the wound could be a s ource of microbial contamina tion.  Proposed § 112.31(b)(1) is 
similar to requirements in current §§ 110.10(a) and 111.10(a) and to prov isions in our GAPs 
Guide (Ref. 10), the AFDO Model Code , various produce industry guidelines (Ref. 89.Ref. 
84.Ref. 99), and a marketing agreement (Ref. 31), and the Codex Code (Ref. 96). 
Proposed § 112.31(b)(2) would require that you instruct your personnel to notify their 
supervisor(s) (or a responsible party) if they have, or if there is a reasonab le possibility that they 
have, an applicable health condition.  Consiste nt with the training requirement proposed in § 
112.22(a)(2), we are proposing this requirement as  a measure specifically directed at preventing 201 
 
sick or infected persons from contaminating covered produce or food-c ontact surfaces and to 
emphasize that individual workers have a responsi bility – every day – to take action to prevent 
contamination due to their own illn ess or infection.  In a small or very small business, such as a 
farm largely operated by a husband and wife, the impact of proposed § 112.31(b)(2) would, in 
essence, be for a sick worker to take appropr iate steps to exclude hi mself or herself from 
working in any operations that may result in c ontamination of covered produce or food-contact 
surfaces with pathogens.  Proposed § 112.31(b)(2) is similar to requirements in current §§ 110.10(a) and 111.10(a) and to provisi ons in the AFDO Model code 
(Ref. 20), and a produce 
industry guideline ((Ref. 46). We seek comments on the not ification and other proposed 
requirements related to workers health.  Proposed § 112.32 would require that personnel us e certain hygienic practices.  Proposed § 
112.32(a) would require that personn el who work in an operation in which covered produce or 
food-contact surfaces are at likelihood of cont amination with known or reasonably foreseeable 
hazards use hygienic practices while on duty to th e extent necessary to protect against such 
contamination.  Hygienic practices can prevent introduction of microbial (such as bacteria and 
viruses that could be presen t in saliva or on skin) contamination of covered produce 
(Ref. 108).  
Inadequate hygienic practices among workers ha ve been associated with outbreaks transmitted 
by various produce commodities, including strawbe rries, green onions, mamey, leaf lettuce, and 
basil (Ref. 107).    Proposed § 112.32(a) is similar to requirements in current §§ 110.10(b) and 
111.10(b) and to provisions in our GAPs Guide (Ref. 44), the AFDO Model Code (Ref. 20), 
various produce industry guidelines (Ref. 46.Ref. 44), a marketing agreement (Ref. 31), and the 
Codex Code (Ref. 96).   202 
 
Proposed § 112.32(b) would require that personnel who handle (c ontact) covered produce use 
specific hygienic practices to satisfy the requirements of proposed § 112.32(a).  Proposed § 
112.32(b)(1) would require the speci fic practice of maintaining ad equate personal cleanliness to 
protect against contamination of covered pr oduce and food-contact surfaces.  Requiring that 
workers maintain adequate personal cleanline ss is similar to requirements in current §§ 
110.10(b) and 111.10(b) and to prov isions in the Codex Code (Ref. 96).  We would expect that 
maintaining adequate personal cleanliness would include wearing adequate outer garments as 
necessary and appropriate to protect against c ontamination of covered produce and food-contact 
surfaces.  Outer garments (e.g., smocks, aprons, or coveralls worn over a worker’s personal 
clothing) may be necessary and appropriate wh en a worker conducts an activity that has 
increased potential to contaminate the worker’s personal garments with hazards that could be 
transferred to covered produce or food-contact su rfaces during subsequent activities in which the 
worker may contact covered produc e.   For example, a worker’s personal clothing could become 
contaminated with pathogens while a worker sh ovels manure, and such contamination could be 
transferred from the clothing to covered produce if the worker subsequently harvests covered 
produce wearing the same clothes.  An apron, smock, or coverall worn over the worker’s 
personal clothing while shoveling th e manure could simply be removed before the worker moves 
on to a harvest activity, which would reduce the likelihood of contaminating covered produce 
during the subsequent harvest activity.  We intend to provide further information about adequate 
worker personal cleanliness in guidance. Proposed § 112.32(b)(2) would require that perso nnel avoid contact with  animals other than 
working animals, and that personnel in direct contact with working animals take appropriate 
steps to minimize the likelihood of contamination of covered produce.   Pathogens can be directly 203 
 
transmitted from animals to people when persons touch, pet, feed, or are licked by animals 
because animal hair, fur, saliva and skin can harbor pathogens (Ref. 98.Ref. 99.Ref. 100).  For 
example, transmission of the pathogen Giardia lamblia  from animals to humans was linked to an 
outbreak of foodborne illness associated with consumpti on of contaminated produce (Ref. 109).   
Proposed § 112.32(b)(3) would require that pe rsonnel wash hands thoroughly, including 
scrubbing with soap and running water that sa tisfies the requirements of § 112.44(a) (as 
applicable) for water used to wash hands, a nd that personnel dry hands thoroughly using single-
service towels, clean cloth towels, sanitary towe l service or other adequa te hand drying devices 
on specified occasions.  Those specified occasion s include before starting work; before putting 
on gloves; after using the toilet; upon return to the work station after any break or other absence 
from the work station; as soon as practical after touching animals (including livestock and 
working animals) or any waste of animal origin; and at any other time when the hands may have 
become contaminated in a manner that is reasonab ly likely to lead to c ontamination of covered 
produce with known or reasonably foreseeable hazards.  Under proposed § 112.32(b)(3), we 
would not expect workers to immediately stop work and wash their hands each time hands 
become soiled during the usual course of farm work with dirt or plant litt er.  However, we would 
expect workers to have sufficient training to r ecognize potential sources of hazards and to wash 
their hands when appropriate.  We tentativel y conclude that propos ed § 112.32(b)(3) provides 
sufficient flexibility for operations to provide running water in a manner best suited to the 
conditions of use.  For example, water can be supplied by a Public Water System, private well, 
or other source satisfying th e requirements of § 112.44(a) through plumbed connections to 
building faucets (e.g., inside a packing house) to  supply running water throughout the facility.  
Alternatively, water supplied from sources above and used to fill clean, portable water containers 204 
 
suited to field use (such as a ca rboy, tank, water buffalo, or similar container) fitted with a valve, 
spout, or spigot such that wate r released passes over the hands also can provide adequate running 
water for washing hands.  Under proposed § 112.44(a), with certain exceptions set forth in 
proposed § 112.45, you must test the quality of wa ter used for hand washing during and after 
harvest to ensure that there is no detectable generic E. coli (see section V.E. of this document).  
Workers often touch produce with  their bare hands, and the pr oduce covered by this rule would 
not necessarily have a “kill step” to adequate ly reduce pathogens that could be transmitted 
through bare-hand contact.  Hand-washing, when done effectively, can eliminate both resident 
bacterial contamination (such as on the hands of  a worker who may not realize he is ill or 
infected) and transient microbial contamination (suc h as bacteria, viruses, and parasites that gets 
onto hands through contact with the environment) (Ref. 110).  As a result, hand-washing is a key 
control measure in preventing contamination of covered produce and food-contact surfaces (Ref. 
26).  The effectiveness of hand-washing is determined by multiple factors, including whether or 
not soap is used, the quality of water used, the duration of scrubbing and rinsing, and whether 
hands are dried.  Soap serves as an emulsifier that enables dirt and oil to be suspended and 
washed off (Ref. 110).  Rinsing hands without using soa p, and not drying hands after washing, 
can promote the spread of microorganisms.  For example, rinsing hands without using soap can 
loosen microorganisms without removing them , leaving the microorganisms more readily 
transferable to the next surface touched (Ref. 110).  An investigation in follow-up to an outbreak 
of foodborne illness caused by E. coli  O157:H7 in Florida found an association between illness 
and visits to fairs where visitors came in c ontact with animals, a nd found that persons who 
washed their hands with soap and wa ter had a decreased likelihood of illness (Ref. 111).  Drying 
hands is important because wet skin is more likely to transmit microorganisms than dry skin 205 
 
(Ref. 110).  In addition, hand-drying has been demonstr ated to remove bacteria from the hands 
and decrease “touch-contact-associated bacterial transfer” after hand-washing (Ref. 112).  
Proposed § 112.32(b)(3) does not prohi bit use of hand sanitizers as a part of the hand washing 
process.  However, our review of hand washi ng indicates that soap and water are far more 
effective than sanitizers in removing pathogens.  The effectiveness of hand sanitizers has been 
shown to be highly dependent upon the removal of or ganic material from the hands prior to their 
use, as the presence of dirt, grease, or soil signi ficantly reduces their eff ectiveness in eliminating 
bacteria on hands  (Ref. 107). 
Proposed § 112.32(b)(3) is similar to  provisions in our GAPs Guide (Ref. 10), the AFDO Model 
Code (Ref. 20), various produce industry guidelines (Ref. 89.Ref. 84.Ref. 99), a marketing 
agreement (Ref. 31), and the Codex Code (Ref. 96).  Several differences exist between proposed § 
112.32(b)(3) and analogous provisions in curr ent §§ 110.10(b) and 111.10(b).  For example, 
proposed § 112.32(b) would not specify, in additi on to the requirements for hand washing, that 
hands also be sanitized if necessary to prot ect against microbial co ntamination, while both §§ 
111.10(b) and 111.10(b) have such a requirement .  We tentatively conclude that the 
circumstances where use of a hand sanitizer as an additional measure to  reduce likelihood of 
contamination with pathogens would be limited on a farm. Hand sanitizers are less likely to be 
effective on a farm than in a processing plant, si nce growers’ hands are mo re likely to get dirty 
during production on a farm and the resulting pr esence of organic material on the hands would 
impede the effectiveness of hand sanitizers (Ref. 113).   
In addition, proposed § 112.32(b)(3)( v) would specifically require washing hands after touching 
animals, a requirement that is not included in current § 110.  We are prop osing this requirement 
here because contact with animals is more lik ely to happen on a farm. In addition, the National 206 
 
Association of State Public Health Veterina rians has recommend washin g hands after touching 
animals as a protection against outbreaks of E. coli O157:H7, Salmonella  Enteritidis , 
Cryptosporidium parvum , non-O157 STEC, Salmonella typhimurium , and Campylobacter jejuni  
(Ref. 111).   
Proposed § 112.32(b)(3) also would repeat some of the characte ristics of an adequate hand-
washing facility specified in proposed § 112.130 (i.e ., soap, running water of specified microbial 
quality, and adequate drying devices).  Currently , in our CGMP regulation for food facilities, § 
110.37(e) identifies examples of how to achieve compliance with  the requirements for an 
adequate hand-washing facility, but it does not repeat them in  the requirement in § 110.10(b) 
regarding workers washing their hands.  In  proposed § 112.32(b)(3) (and in proposed § 112.130), 
we are proposing to identify specific characteri stics of an adequate hand-washing facility 
because many of these facilities are likely to be in outdoor growing areas and be portable.  
Standard features that we have co me to expect as a matter of cour se in a hand-washing facility in 
a building used for manufacturing/processing food may not be standard in a portable hand-
washing facility.  Moreover, the outdoor nature of many areas where covered activities take 
place naturally presents workers with situations  where they will get di rt on their hands, and 
workers may be routinely handling food, with th eir bare hands, that will not be cooked to 
adequately reduce pathogens.  Therefore, we  believe it is appropriate to repeat these 
requirements in the proposed provisions for work ers to wash their hands as well as in the 
proposed provisions directed to hand-washing facilities. We s eek comment on the hand-washing 
proposals described above.   Proposed § 112.32(b)(4) would require that, if yo u choose to use gloves in handling covered 
produce or food-contact surfaces, you maintain gl oves in an intact and sanitary condition, and 207 
 
that you replace such gloves when you are no longer able to do so.  We are not proposing to 
require the use of gloves, but gloves are used in many operations to protect workers’ hands.  
While gloves also provide a barrie r that can reduce the potential for pathogens on workers’ hands 
to contaminate covered produce, gloves themselves , whether re-usable or disposable, can transfer 
pathogens to covered produce if the gloves become contaminated (Ref. 26).  If gloves are used in 
handling covered produce or food c ontact surfaces, requir ing that such gloves be either in an 
intact and sanitary condition, or else be replace d, reduces the potential for the gloves to be a 
source of contamination for covered produce.  Proposed § 112.32(b)(4) is similar to requirements 
in current §§ 110.10(b) and 111.10(b).  Our GAPs Guide (Ref. 10), various produce industry 
guidelines (Ref. 89.Ref. 84.Ref. 99) and the Codex Code (Ref. 96) include specific provisions 
directed to the use of gloves.  The AFDO Model Code (Ref. 20) and a marketing agreement (Ref. 
31) direct farms to establish policies to ensure prop er use of gloves.  It has been reported that 
glove use can foster a “false sense of security” th at can lead to less sani tary practices such as 
wearing the same pair of gloves for extended pe riods of time without cleaning them, or washing 
hands infrequently (Ref. 114).  If your workers wear gloves, you should ensure that they know 
that wearing gloves in no way diminishes the im portance of washing hands, and that gloves must 
be maintained and replaced, when necessary and appropriate. Proposed § 112.33 would require that you take measur es to prevent visitors from contaminating 
covered produce and food-contact surfaces with mi croorganisms of public health significance.  
Proposed § 112.33(a) would define a visitor as any person (other than personnel) who enters 
your covered farm with your permission.  Propo sed § 112.33(b) would require that you make 
visitors aware of policies and procedures to protect covered produce and food-contact surfaces 
from contamination by people, and that you take all steps reasonably necessary to ensure that 208 
 
visitors comply with such policies and proce dures.  Proposed § 112.33(c) would require that you 
make toilet and hand-washing faci lities accessible to visi tors.  In contrast to food processing 
facilities, on-farm visitors often enter areas where covered produce is grown and harvested, 
particularly on farms that offer c onsumers an opportunity to pick th eir own fruits and vegetables.  
As with workers, visitors can transmit pathoge ns to covered produce and food-contact surfaces.  
Thus, we are proposing to requir e that farms address the potentia l for visitors to contaminate 
covered produce, even though we have no similar requirements in regulations such as parts 110 
and 111.  Proposed § 112.33 is similar to provisions in our GAPS Guide (Ref. 10), the AFDO 
Model Code (Ref. 20), various produce industry guidelines (Ref. 89.Ref. 84.Ref. 99), a marketing 
agreement (Ref. 31), and the Codex Code (Ref. 96).  A farm could comply with these proposed 
requirements by, for example, indicating the loca tion of restrooms and hand-washing facilities 
accessible to visitors and clearly posting rules applicable to visitors where they are likely to be seen and read at the beginning of a visitor’s visit, such as near the entrance or cash register at a 
“pick-your-own” farm operation.  
 
E. Subpart E – Standards Dir ected to Agricultural Water 
As proposed, subpart E discusses science-based minimum standards directed to agricultural 
water that are reasonably necessary to minimize th e risk of serious adverse health consequences 
or death from the use of, or exposure to, cove red produce, including those reasonably necessary 
to prevent the introduction of known or reasonab ly foreseeable hazards into covered produce, 
and to provide reasonable assura nces that the produce is not adulterated u nder section 402 of the 
FD&C Act. 
1. Comments Relevant to  Proposed Provisions  209 
 
We received some comments in response to the 20 10 FR notice that addresse d issues relevant to 
agricultural water.  Several comments expresse d concern that our proposed regulations could 
have an adverse effect upon or be in conflic t with on-farm conservation or land management 
practices efforts; or that they  could set standards for limiting all animal access to surface waters 
(e.g., by fencing or other barrier) or prohibit vegeta tion (normally used to st abilize soil or for use 
as a natural water filter) surr ounding surface water sources.   
In developing the provisions in proposed part  112, we consulted with USDA’s National Organic 
Program and Natural Resources Conservation Servi ce, U.S. Fish and Wildlife Service, and the 
EPA (Ref. 115) to take into consideration conservati on and environmental pr actice standards and 
policies established by t hose agencies.  We recognize the impor tance of ensuring, to the extent 
possible, that our proposed provisi ons are compatible with existi ng conservation practices in the 
management of agricultural water systems.  In proposed § 112.42(a)(1)-(5), we would require 
that you inspect your entire agricultural water sy stem at the beginning of every growing season, 
focused on identifying conditions that are reason ably likely to introduce known or reasonably 
foreseeable hazards into or onto covered pr oduce or food-contact su rfaces.  A similar 
(re)inspection would be required in proposed  §§ 112.44(b) and (c) if the water you use for 
certain purposes does not meet the microbiologica l criteria described in those provisions.  In 
each of these provisions, however, we do not de scribe specific inspection findings likely to 
adversely affect microbial water quality and re late them to specific required actions.  For 
example, we do not propose that vegetation su rrounding an on-farm pond be cut back and/or 
removed or that fencing must be used to prevent access to a pond by wildlife and domestic 
animals.  We recognize that each farm, State,  region, or produce commodity group may approach 
water management differently with respect to the likelihood of contamination of agricultural 210 
 
water and the use of specific conservation practices  that may be appropriate or consistent with 
measures used to mitigate the likelihood of contamination.  Practices used for one region or commodity may not be appropriate for others based upon historical experience.  Under this 
proposed subpart, we would require that you addr ess such issues only if they are reasonably 
likely to contribute to contamination of covered produce, and we would provide flexibility in the 
way in which you address any identified hazards, such that measures you implement to mitigate 
such hazards can be consistent with your curren t conservation practices.  This approach allows 
you to put in place measures you deem most effe ctive in addressing the potential for water 
contamination and to assess the effectiveness of t hose measures as they may be reflected in your 
microbial water quality data.   We also received a number of comments expres sing concern about costs and associated burden 
related to testing of agricultura l water, including pathogen testi ng, indicators, and frequency of 
testing.  As described in section in the QAR , pathogen presence and distributions in the 
environment and water systems can be expected to be sporadic, with survival dependent on a 
multitude of factors.  Thus, broad generalizati ons concerning their presence or persistence in 
water or on produce are problematic, and their detection difficult.  Th erefore, rather than testing 
for the presence or levels of various pathogeni c microorganisms, we propose to use a microbial 
indicator as a monitoring measure to assess the potential for contamination.  After considering various microbial indicators of  water quality (see section V.E.2. of this document), we 
tentatively conclude that  generic Escherichia coli
 (E. coli ) is best suited for this purpose.  It can 
be found in at least 90 percent of all human and animal feces (Ref. 116) and is most closely 
associated with incidents of fecal contamination (Ref. 107.Ref. 108.Ref. 109.Ref. 110.Ref. 
108.Ref. 111.Ref. 112).  There are multiple test methods, commercial kits, and formats available 211 
 
at relatively low cost, and the accuracy, precision, and sensitivity  of these analytical testing 
options would meet the requirements in this proposed rule.  Although the correlation between 
generic E . coli  and fecal contamination is strong, as disc ussed in section V.E.2. of this document, 
generic E . coli  does not always reliably pr edict the presence of pathoge ns despite fecal pollution 
being a known source of pathogeni c microorganisms.  This is e xplainable, however, considering 
the current understanding of pa thogen occurrence and distribution described in the QAR and the 
taxonomic diversity of waterborne pathogens (e.g., b acteria, viruses, and protists).  Thus, generic 
E. coli  monitoring serves as a measure to assess th e potential for fecal contamination, not to 
directly predict the presence of pathogens.   Comments also emphasized that microbial testin g should be performed at a frequency dependent 
upon the results of an assessment of the risks pos ed by your agricultural water system.  We agree 
that the frequency should reflect  the risk.  In proposed § 112.45( a), with certain exceptions, we 
propose to require you to test water used for cer tain purposes at the beginning of each growing 
season, and every three months th ereafter during the gr owing season.  We tentatively conclude 
that this frequency would provide  sufficient information regardi ng the microbial quality of your 
agricultural water.  We are proposing in addi tion in § 112.45(b) that untreated surface waters 
must be tested more frequently  than ground water sources because surface watersheds are subject 
to a greater number of external forces th at shape their overall co mposition, chemistry, and 
microbial water quality (e.g. eros ion, run-off, dust, suspended sediments). We seek comment on 
our proposed approach.  A number of comments related to quantifying risks associated with the use of agricultural water 
as a function of water source, time of applica tion, irrigation method, a nd commodity type.  Our 
research shows that this is an extremely diffi cult task.  In the QAR, we considered various 212 
 
factors relevant to produce production and harv esting, including water sources and use (See the 
QAR document).  Some conclusions related to likelihood of produce contamination associated 
with water use can be drawn, although the releva nce of these findings and whether they can be 
generalized across commodities, re gions, and climates is not known.  For example, Stine et al 
(2005) (Ref. 109) and Song et al. (2006) (Ref. 117) provide strong evidence that subsurface drip 
irrigation lowers the likelihood of waterborne co ntamination compared to furrow or overhead 
irrigation.  These authors also suggest that proxi mity of the edible portion relative to water 
applied and surface texture of the edible portion play key roles in likelihood of contamination.  
In addition, according to a WHO risk assessment (Ref. 118) of wastewater use in agriculture, 
pathogen (bacteria, protists, and vi ruses) die-off during the interv al between last irrigation and 
consumption is approximately 1 log per day, alt hough the rate varies with climatic conditions.  
Other measures that can be protective include cessation of watering, choice of irrigation method 
(localized irrigation—bu bbler, drip, trickle is more pr otective than flood, furrow, or 
spray/sprinkler), and food prep aration measures (washing) (Ref. 118).  It is difficult to determine 
to what extent this assessment can be applied to  water systems that are not based on wastewater 
use where high pathogen loads can be expected.  Produce grown with water of significantly 
higher water quality continues to be  implicated in disease outbreaks (Ref. 119).  These outbreaks 
not only illustrate the ch allenge in assigning absolu te risk reduction values to measures used in 
the mitigation of risk, but also the sporadic  nature of pathogen occurrence and localized 
conditions leading to the persistenc e of pathogens in the environment.                 
A few comments recommended that equipment used to hold or convey water should be inspected 
to ensure that it is clean.   213 
 
We agree that equipment used to hold or convey water should be maintained in a manner 
necessary to protect against c ontamination.  In proposed 112.42 (c ), we propose to require that 
all agricultural water distribution systems must be adequately maintained as necessary and appropriate to prevent the wate r distribution system from bein g a source of contamination to 
covered produce, food-contact su rfaces, areas used for a cove red activity, or water sources, 
including by regularly in specting and adequately storing all e quipment used in the system.  In 
addition, in proposed 112.42 (b), we propose to require that all agri cultural water sources that are 
under the control of a covered farm  (such as wells) must be adequately maintained by regularly 
inspecting each source and keeping the source fr ee of debris, trash, domesticated animals, and 
other possible sources of contamination of c overed produce to the extent practicable and 
appropriate under the circumstances.  We seek comment on our proposals and appr oach related to ag ricultural water. 
 
2. Water Quality Testing, Indicators, and Standards 
In this subsection, we present a technical di scussion of issues related to water quality 
such as testing samples, microbial quality indi cators, and microbial qua lity standards.  We 
discuss these issues in greater detail in this subsection to fu rther support the provisions proposed 
below related to water quality tes ting and microbial indicators.   
A fundamental component in assessing the adeq uacy of water for its intended use is a 
routine sampling and microbial testing program 
(Ref. 120.Ref. 29).  Water sampling and testing 
allows for informed decisions regarding the mana gement of water use, such as choosing a water 
source and combining that sel ection with, for example, the irrigation method for a specific 
commodity or time period prior to harvest.  Test ing for microbial quality of water can identify 214 
 
possible fecal contamination at the water source or in a section of its distribution system (e.g., 
line break).  Additionally, regular testing data may be used to id entify seasonal (or other) trends 
and highlight areas of the system that may require  attention.  For example, regular testing results 
may show that periodic increases in indicator organisms are corre lated with precipitation levels 
or suspended sediments in surface waters, providi ng useful information about when and how that 
water source can be safely used.      
Microbial water quality testing can be perfor med using a variety of  methods that have 
been validated for water testing.  A key elemen t of any testing program is determining the 
indicator organism or specific pathogen(s) and th e frequency of testing.  The sensitivity of the 
method is also important, although most test met hods available today have sensitivities that 
match or exceed requirements for EPA drinking water and FDA bottled water standards.   
Surface water quality and pathogen monitoring studies reported in the literature often 
quantify indicator organisms or pathogens on a m onthly basis.  However, most studies do not 
specifically address the impact of water quality on produce safety (Ref. 115.Ref. 116.Ref. 
117.Ref. 118).  A lack of consensus among the diffe rent recommendations and approaches 
underscores the complexity and uncertainty in wa ter quality sampling and testing strategies.  
Nevertheless, a vast majority of studies that ad dress frequency of testing recommend that surface 
water sources should be sampled more frequently than ground water sources (Ref. 121).   
Two key determinants of an appropriate testi ng frequency emerge from this information: 
(1) variability of the water source  and (2) the extent to which it can be protected.  The discussion 
above suggests that water obtained from a public water source is le ast likely to be a vehicle for 
pathogen contamination of produce, followe d by water obtained from deep underground 
aquifers, shallow wells, and surface waters, in that order.  This is consistent with findings 215 
 
reported in the literature (Ref. 122.Ref. 29).  For purposes of defining likelihood of 
contamination, we further divide surface water into two types, based on the potential for 
contamination (through runoff), and the degree to which potential contamination can be 
recognized and controlled (i.e., (1) surface waters  where runoff is difficult to recognize and 
control because of the size of th e watershed ( e.g., river or lake) and (2) surface waters where 
runoff can be easily detected and which can be ma naged so as to protect them from runoff (e.g., 
on-farm reservoir or pond)).  Runoff is us ed here in different iating the likelihood of 
contamination of surface water be cause it has the potential to carry pathogens and is known to 
mobilize pathogens from sediment reservoirs to the water column (Ref. 117.Ref. 120.Ref. 
121.Ref. 122.Ref. 123) as well as carry pathogens to the su rface water system from sources such 
as failing septic systems and deposited animal feces (Ref. 123.Ref. 124).   
a. Microbiological indicators of water quality A primary consideration in establishing a mi crobiological water qual ity testing program 
is the choice of target organism(s). Two gene ral approaches are commonly used: test for the 
presence of an indicator organism(s) that ma y signal the presence of pathogens or test for 
pathogens themselves.  In the United States, bact erial indicators have a long history of being 
used to demonstrate the safety of drinking water and adequacy of its treatment at the source.  
They have also been used to monitor the stat us of drinking water in distribution systems and 
determine if surface waters are microbiologically safe for recr eational use (e.g., swimming) and 
shellfish harvest 
(Ref. 123).   
Bacterial fecal indicators are non-pathogenic microorganisms that are commonly found in 
the intestines of warm-blooded an imals that are easily isolated and quantified as a measure of 
fecal contamination and potential for enteric pa thogens.  Desired characteristics for effective 216 
 
indicator organisms include: ease of detection; being present only when fecal contamination or 
pathogens are present; and, being in numbers that  correlate with the amount of contamination, 
numbers of pathogens and risk of illness.  Surviv al times of indicator organisms in sediments and 
in water should be equal (or greater) to thos e for pathogens and thei r detection should be 
accomplished by simple, rapid methods at low cost .  Indicator microorganisms are widely used 
in water quality testing because of their broad utility across many types of water but no single 
indicator that is universally accepted (Ref. 123).   
Pathogen detection has the obvious advantage of  directly targeting microorganisms in 
water that are a risk to public health.  Ho wever, sampling water for pathogens may present 
additional challenges, including larg er sample sizes to facilitate  detection, inherently higher 
costs, and the wide array of pot ential target pathogens (i.e., th e presence or absence of one 
pathogen may not predict for the presence or absence of other pathogens).   
A number of indicator microorganisms have  been used to predict the presence of 
pathogens in water, with varying degrees of success.  These include total coliforms, fecal 
coliforms, enterococci, generic E. coli , and coliphages.  However, th eir presence does not always 
signal the presence of pathogens and the absen ce in their detection is  not assurance that 
pathogens are absent (Ref. 126.Ref. 127.Ref. 128.Ref. 129.Ref. 130).   
Consequently, Gerba (2009) (Ref. 120)  suggested indicators be  defined by a purpose for 
which they are better suited instead as an i ndicator for pathogens.  For example, efficacy of 
treatment (e.g., public water systems) or inte grity in manufacturing processes (e.g., bottled 
water) can be effectively monitored by total coli forms because these environmental bacteria are 
not expected to survive the treatment conditi ons or be introduced during the manufacturing 
process.  Their presence in treated municipal wa ter or in bottled water may signal an inadequate 217 
 
treatment or deficient manufacturing step meritin g investigation and subsequent corrective action 
to resolve the problems identified.  Another ex ample is using fecal i ndicator bacteria (e.g., 
enterococci or generic E. coli ) to assess the risk of gastrointestin al illness (or other adverse health 
conditions) in marine and freshwater swimmers, b ecause their presence is statistically correlated 
to adverse health outcomes in these groups (Ref. 119.Ref. 120).  Generic E. coli  alone, as an 
easily distinguishable member of the fecal colifo rm group, is more likely than the fecal coliform 
group as a whole to indicate fecal pollution (Ref. 120).  Used in this way, indicator organisms are 
not used specifically to predict the presence of pathogens, but are useful predictors of 
undesirable conditions (e.g., ineffect ive treatment, defective manufact uring process, presence of 
fecal material).   
Total coliforms have frequently been used to assess water quality of several different 
types of natural waters (e.g., freshwater and mari ne) but their use for this purpose has decreased 
recently as they have been found to be pres ent in natural water both because of fecal 
contamination and as natural envi ronmental inhabitants.  They ar e regularly isolated from soil, 
plants, vegetables, and effluents from agricultural and food industries but their presence does not 
reliably signal a fecal contamination event (Ref. 131.Ref. 112).  Fecal coliforms share a similar 
problem.  Fecal coliforms are coliforms that ar e capable of growth at higher temperatures, 
conditions similar to those which can be found in the mammalian gut.  However, some of its 
members (e.g., Klebsiella, Citrobacter, Enteroba cter spp.) can normally be found outside the 
intestine including soil, water, vegetation, fresh vegetables, sila ge, insects, and many others (Ref. 
124) and there is ample evidence that they can grow and multiply there (Ref. 132.Ref. 133.Ref. 
114.Ref. 123).  This makes using fecal coliforms as indicators for fecal contamination 218 
 
problematic, as it would be difficult to separate in creases in their numbers due to natural forces 
(e.g., precipitation, erosion, wind, te mperature) from increases due to fecal contamination events. 
Generic E. coli  is a member of both the coliform a nd fecal coliform groups but has been 
shown to more consistently be associated w ith fecal contamination than other indicators (Ref. 
134.Ref. 135.Ref. 133.Ref. 136.Ref. 137.Ref. 138.Ref. 112).  It can be found in  at least 90 percent 
of all human and animal feces (Ref. 108)(Ref. 116) where it persists, more than other transient 
fecal coli forms (Ref. 125.Ref. 124).   While its association with  fecal contamination is very 
strong, it has also been isolat ed from environments with no apparent fecal contamination, 
including tropical watersheds (Ref. 126) and paper mill effluents (Ref. 127).   Outside of these 
findings, reports of generic E. coli  growth and proliferation outs ide the gut (e.g., in water) are 
generally rare.  Generic E. coli  demonstrates variable surviv al times in water but may only 
persist from 4 to 12 weeks at 15 – 18 degrees Celsius (Ref. 116).     
Generic E. coli  has an extensive history of use as an  indicator of fecal contamination and 
is considered the best indicat or for monitoring water quality (Ref. 119).  Its detection and 
enumeration can be performed using a variety of  commercial products at relatively low cost.  
However, its ability to signal fecal contamina tion events is dependent upon sampling frequency 
and location relative to the source of contaminat ion.  Thus, instances of non-detection are not 
considered confirmation of the absence of fecal contamination because sampling frequency may 
not be adequate to detect events occurring over short periods of time.  Sampling results can only 
be considered snapshots of water quality over time.  Moreover, the fate and transport of generic E
. coli  in watersheds may be different than other fecal constituents in response to localized 
conditions (e.g., sunlight, temperature) (Ref. 128.Ref. 129.Ref. 130).     219 
 
One challenge in using indicator organism s to predict water quality is correlating 
information concerning their numbers to the pres ence or absence of pathogens (as compared to 
the presence or abse nce of fecal material ).  Although generic E . coli  is recognized as a good 
indicator of fecal contamination, pathogens are not always present in that fecal material because 
their distribution and persisten ce is sporadic.  As a conseque nce, the record of generic E . coli  as a 
predictor of pathogens is mixed.  The Canadi an Federal-Provincial-Territorial Committee on 
Drinking Water states generic E.  coli is unsatisfactory in predic ting the presence of Giardia , 
Cryptosporidium , and enteric viruses (Ref. 119.Ref. 124) and Horman et al. 2004 (Ref. 131) found 
poor correlation be tween generic E . coli  and the presence of pathogens (Campylobacter spp., 
Giardia  spp., Cryptosporidium  spp., and noroviruses) in Finnish surface waters.  However, they 
did conclude that the absence of generic E.  coli was a very strong predic tor for the absence of 
pathogens.  Duris et al (2009) (Ref. 132) found generic E . coli  inconsistently correlated to genetic 
markers for generic E . coli  O157 in Michigan and Indiana river water but suggested the 
relationship could be strengthene d by increased sample size.  Alternately, Wilkes et al., 2009 
(Ref. 133) reported generic E . coli  concentrations were the be st indicator of pathogens (E . coli  
O157:H7, Salmonella  spp., Campylobacter  spp, Giardia  and Cryptosporidium ) presence/absence 
in Canadian  watersheds.  Othe rs have noted that generic E . coli  has a better record as an 
indicator for Salmonella  than for E . coli  O157:H7 (Ref. 134).  Review of these studies illustrates 
the complexity of possible inte ractions between indi cators and pathogens in  water, and their 
potential for separate fates within those systems.     
Studies relating indicators, pathogens, and th e risks associated with produce consumption 
are few and are complicated by the relationships described above.  Different survival profiles 
between indicators and pathogens on produce ma y also affect risk.  The World Heath 220 
 
Organization (Ref. 118) proposed a set of pathogen reduction m easures that can be used alone or 
in combination to achieve a 6-7 log pathogen re duction they determined necessary to meet 
health-based targets.  To verify the effectiv eness of the measures, they recommend monitoring 
generic E. coli  levels in treatment effluents and in cr ops at harvest.  They noted that field 
pathogen die-off is variable ( 0.5–2 log per day), dependent on temp erature, sunlight, crop type, 
time, and other factors.   
Produce contamination events that occur dur ing growing, harvesting, packing, or holding 
on farm are generally thought to occur intermittently and at low doses.  As a result, the detection of human pathogens in contaminated produce us ing available testing methodologies remains an 
arduous process.  It is impractic al to test 100% of the product; th erefore sampling plans to collect 
a statistically significant subset must be devise d.  Unfortunately, although su ch testing has in the 
past prevented some contaminated product from  entering the market when pathogens are found, 
it is also very possible that testing can entirely  miss a point contaminati on, thus it cannot provide 
a litmus test for food safety because the sample  size needed to detect low dose, low frequency, 
and non-uniformly distributed contamin ation  is  impractically large 
(Ref. 135).  In addition, 
microbial testing can only detect the pathogens the analytical pro cedures are designed to detect, 
and we tend to only test for pathogens known to  be of concern.  Cons idering the range of 
potential pathogens, these are significant limitations. 
b. Microbial water quality standards The lack of sufficient information to suppor t a pathogen-based micr obiological standard 
for water used in the production of produce ha s led to the adoption of the generic E. coli
 
component of the US EPA recrea tional water standards (for fre quently used beaches) by some 
industry groups (Ref. 44.Ref. 31).  The EPA recreational water st andards were developed from 221 
 
epidemiological studies that correlated the risk of  gastrointestinal illnes s to exposure to marine 
and freshwater by swimmers (Ref. 136).  Generic E. coli  was found to be a good predictor of 
swimming associated illness in freshwater  and the EPA recommended criteria include a 
geometric mean of 126 CFU per 100 ml and a single sample maximum for designated beach 
areas of 235 CFU per 100 ml (Ref. 136).  British Columbia, Canada has announced their 
intention to use a similar a pproach in setting generic E.  coli criteria for irrigation water used on 
produce consumed raw.  Their irrigation criteri a (less than or equal to 77 CFU per 100 ml 
geometric mean) are the same as and were de rived from those used for primary-contact 
recreation (Ref. 137).  See section V.E. of this document fo r additional discussion of this issue. 
The US EPA criteria were developed from epid emiological studies of beach areas subject 
to point source fecal contamina tion rather than non-point source contamination (e.g., birds, 
agricultural and livestock runoff).  Non-point sources may also influence the quality of 
agricultural water.  Further, adverse health outcomes as a consequence of immersion while 
swimming in contaminated water may be different  from those as a result of eating produce 
irrigated with contaminated water.  The routes  of infection and pat hogen mortality rates are 
different in each environment.    
Based upon a WHO analysis of tolerable risk for irrigation water, the minimum microbial 
quality for water used on root crops that are eaten raw is 1000 CFU ge neric E. coli per 100 ml 
(10,000 CFU generic E. coli pe r 100 ml in leaf crops) (Ref. 120.Ref. 118).  According to the 
WHO analysis, using water of this microbial qu ality is dependent upon a 2 log reduction due to 
die-off between last irrigation and consumpti on (includes die-off in the field and during 
distribution) and a 1 log reduction attributed to washing prior to consumption.  This analysis 
recognizes the variable nature of die-o ff values, ranging from 0.5 – 2.0 log per day (Ref. 118).  222 
 
The WHO analysis considers the need for a f our log reduction through dilution, die-off, or 
treatment between the levels of generic E.coli in raw sewage (well re presented in sewage by 
fecal coliform levels) and the levels in irrigation water used on root crops that are eaten raw (3 
log for leaf crops), in addition to  the 3 log reduction discussed above. 
 3. Proposed Requirements a. General requirement Proposed § 112.41 would establish the requirement  that all agricultural water must be 
safe and of adequate sanitary quali ty for its intended use.  The pr inciple of “safe and of adequate 
sanitary quality for its intended use” contains el ements related both to the quality of the source 
water used and the activit y, practice, or use of the water.  Us es vary significantly, including: crop 
irrigation (using various  direct water application methods ); crop protection sprays; produce 
cooling water; dump tank water; water used to clean packing materials, equipment, tools and 
buildings; and hand washing water.  The way in which water is used for different commodities 
and agricultural practices can determine how e ffectively pathogens that may be present are 
transmitted to produce.   
Comparing the probability of contamination of covered produce associated with key 
practices at different st ages of production and across a range of commodities, th e interrelatedness 
of these factors becomes apparent.  The QAR  shows that the likelihood of contamination 
associated with indirect water use for irrigation is  relatively low compared to irrigation water that 
directly contacts produce 
(Ref. 2).  Therefore, in Section V.A .2.b (Definitions), we propose to 
define “agricultural water” to mean water used in covered activities on covered produce, where 
water is intended to, or is likel y to, contact covered produce or food-contact surfaces, including 223 
 
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 (inc luding water used for washing or cooling 
harvested produce and water used for preventi ng dehydration of covered produce).   As we 
propose in § 112.3(c), “covered produce” refers to the harvestable or harvested portion of the crop.  As proposed, “agricultural water” does not
 include indirect wate r application methods 
used during growing.  For example, generally, th e water used for drip or furrow irrigation in 
apple orchards would not be c onsidered agricultural water because the water is unlikely to 
contact the harvestable portion of the crop.  As another example, generally, the water used for 
overhead spray irrigation of romaine lettuce would be considered agricultural water because the 
water is likely to contact the ha rvestable portion of the crop.  We  are proposing to distinguish 
between water that is intended to, or is lik ely to, contact covered produce or food-contact 
surfaces (e.g., direct water application method irri gation water) and water that is not intended to, 
or is not likely to, contact covered produce or food-contact surfaces based on the relative 
likelihood of contamination from water that cont acts covered produce and the need for measures 
to minimize such likelihood.   
If finalized as proposed, indirect water appl ication methods would not  be subject to the 
requirements of this rule.  While  indirectly applied water is un likely to contact produce or food-
contact surfaces, we recognize that it presents the possibility of produ ce contamination.  For 
example, use of contaminated water in drip or furrow irrigation may still serve as a vehicle for 
bringing contaminants into the growing environm ent which may potentially be transferred to 
produce by rain splash, workers, or equipment; us e of contaminated water for dust abatement on 
farm roads may also be transferred to produce by run-off, rain splash, workers, or equipment.   224 
 
Indirect water application me thods would remain subject to  Section 402(a)(4) of the 
FD&C Act.  That is, indirect water applicati on may adulterate produce if, considering the water 
quality and the manner of its application, the us e of the water causes pr oduce to be prepared, 
packed, or held under insanitary conditions where by it may have been contaminated with filth or 
rendered injurious to health.  Moreover, if a path ogen is detected in or on produce, such produce 
would be considered adulterated und er Sections 402(a)(1) of the FD&C  Act, in that it contains a 
poisonous or deleterious substance which may rende r it injurious to hea lth.  Therefore, we 
tentatively conclude that indirect  water application methods do not need to be covered within the 
scope of “agricultural water” for the purposes of this rule.   
We ask for comment on the limited scope of “agricultural water” to only water that is 
intended to, or likely to contact  covered produce or food-contact  surfaces.  We also seek 
comment on its resulting effect on the applicabil ity of the general requirement in proposed § 
112.41 that agricultural water must be safe and of adequate sanitary quality for its intended use, 
to only water that is intended t o, or likely to, contact covered produce or food-contact surfaces.  
Water that is not safe or of adequate sani tary quality for its intended use may lead to 
contamination of covered produce, even where the water use is indirect.  We have previously 
recommended measures such as indirect water us e when water quality is poor or unknown as a 
measure to minimize risk (Ref GAPs Guide).  C onsidering the FD&C Act would still apply to 
such uses, and that there is a lower likelihood of  contamination of produce by indirect water use, 
is there a need to subject indirect water use, including water used for dust abatement, to the 
general requirement in proposed § 112.41?  We welcome comment on this approach, as well as 
other actions that have been found to be  effective through practice and experience. 225 
 
We also considered proposing some requireme nts for water that is  used during growing, 
but which does not contact the harvestable portion  of covered produce.  For example, water that 
did not contact produce would not have been su bject to any testing re quirement, although we 
considered requiring this water a nd all agricultural water to be of safe and adequate sanitary 
quality for its intended use (proposed § 112.41).  We  also considered requir ing indirect water to 
comply with proposed § 112.42(a) (sanitary su rvey) and § 112.42(b) th rough (d) (adequately 
maintaining water sources under your control).  If we did include both direct and indirect water 
use in the definition of “agricu ltural water” in the fi nal rule, which of the proposed requirements 
for agricultural water described in section V. E. of this document would (or would not) be 
appropriate for indirect water us e?  Are there other factors that  we should consider?  In every 
application of water, careful consideration should be given to what you know about the water’s 
quality at its source, the imp act your distribution system ma y have on the water quality, and 
when or how that water is to be used.  For example, water that contains Salmonella  would not be 
safe or of adequate sanitary quality for its inte nded use when used in a postharvest dump tank for 
tomatoes.  Salmonella  is a food safety hazard that is well- documented to present a risk of severe 
adverse health consequences or death, and tomatoes can become contaminated by water 
containing Salmonella  (Ref. 138.Ref. 139.Ref. 140).  As another example, when the surface water 
(e.g., river) that you use for crop irrigation usin g a direct application method has a noticeable 
decrease in quality due to an upstream event lik e the failure of a waste water treatment plant, 
resulting in the accidental discharge of untreated  municipal sewage into  the river, your water 
source would not be safe or of ad equate sanitary quality for its in tended use until the discharge is 
over and the water has been tested because the in completely treated sewage in the discharge is 226 
 
likely to contain pathogenic microorganisms that  could compromise the safety of irrigated 
covered produce.   
The most frequently used irrigation methods  include overhead, surface and subsurface 
drip, furrow, flood, and seep irrigation (Ref. 29).  These practices may be commodity-specific 
and choices may be limited by the availability of  different water sources, crop needs, climate, 
precipitation levels, or regional practices.  Each  irrigation method presen ts a different likelihood 
of contamination, independent of the water source and its applicati on to a particular commodity.  
For example, the likelihood of produce contamin ation may be reduced if irrigation water is 
delivered by subsurface drip irrigation compared to using the same water to irrigate by overhead 
spray (Ref. 141.Ref. 122).  Researchers also concluded that both the physical properties of the 
edible portion of the crop, such as surface textur e, and the location of the edible portion of the 
plant in relation to irrigation water play ed significant roles in contamination (Ref. 130).  As 
discussed in the QAR, the timing of  irrigation water app lication also plays a role in minimizing 
the persistence of contamination.  For exam ple, water containing elevated generic E . coli  used in 
overhead irrigation shortly before harvest may increase the likelihood of covered produce being 
contaminated with the pathogen at harvest, but the same water could safely be used to establish a 
crop and throughout the majority of the growing season because , as discussed in the QAR, 
pathogens die-off over time on the surface of produ ce.  Water used for washing hands during and 
after harvest, sprout irrigation, directly contacting produce during or after harvest (such as in 
washing and cooling, or to make ice that direct ly contacts produce), ma king treated agricultural 
tea, and water or ice that will contact food cont act surfaces that contact covered produce presents 
an even greater likelihood of microbi al contamination of covered produce (Ref. 131.Ref. 132).  
Waterborne pathogens can be tran sferred to covered produce with li ttle opportunity for die-off if 227 
 
contaminated water is used for hand washing during or after harvest, or in harvest, packing or 
holding activities where it dire ctly contacts produce or surfaces that contact produce and, 
therefore, it is important to ensure that the water is safe and of adequate sanitary quality for such 
uses. Moreover, the high nutrient, high moisture  conditions inherent to  sprout production and 
agricultural teas no t only support pathogen survival but are also conducive to their amplification 
if present (Ref. 142.Ref. 16).  Again, the selection of a water source for these uses must ensure 
that the water is safe and of adequa te sanitary quality for that use.   
b. Measures regarding agricultural wa ter sources and distribution systems 
Proposed § 112.42 would establish the measures  that you must take with respect to 
agricultural water sources, water distribut ion systems, and pooling of water.   
Proposed § 112.42(a) would establish that at the beginning of a growing season, you must 
inspect the entire agricultural water system under your control (including water source, water 
distribution system, facilities, and equipment), to identify conditions that are reasonably likely to 
introduce known or reasonably foreseeable hazards into or onto covered produce or food-contact 
surfaces in light of your covered produce, prac tices, and conditions, including consideration of 
the following:  (1) The nature of each agricultural water source  (for example, ground water or surface water); 
(2) The extent of your control over  each agricultural water source;  
(3) The degree of protection of each agricultural water source;  
(4) Use of adjacent or nearby land; and (5) The likelihood of introduction of known or re asonably foreseeable hazards to agricultural 
water by another user of agri cultural water before  the water reaches your covered farm. 228 
 
Human pathogens can enter an agricultural wa ter system anywhere from its source to 
point of use.  Central to the prevention of pathogen contaminati on of agricultural water is an 
inspection of water source and the components of the distribution system to identify potential 
routes of contamination.  Insp ections of water sources and com ponents of its distribution system 
are recommended by government and industry references (Ref. 10.Ref. 20.Ref. 45.Ref. 44).      
Generally, inspection of the agricultural water sy stem under your control be ginning at the water 
system source is the first opportunity for ensuring that it will deliver wate r that is safe and of 
adequate sanitary quality for its intended use.  Inspection of  your water source provides an 
opportunity to identify and characterize activities a nd situations that may lead to contamination 
of your agricultural water.  Furt her, inspection results provide you with historical knowledge of 
your water sources, their quality, and f actors that may aff ect their quality (Ref. 31).  Inspection of 
the water source and any equipment used to obt ain the water from the source (e.g., well head, 
pumps, pipes) can ensure that the water that en ters the distribution system is suitable for its 
intended use.   
Proposed § 112.42(a)(1) requires you to consider the nature of your agricultu ral water sources to 
identify conditions that are reasonably likely to introduce known or reasonably foreseeable 
hazards into or onto covered pr oduce or food-contact su rfaces.  As discussed in the QAR, ground 
water which is often believed to be pathogen fr ee can be contaminated.  Ground water can also 
be compromised and its water quality degraded  if wells are imprope rly constructed, poorly 
maintained, or improperly located (e.g., near ar eas of extensive livestock production or fields 
where manure is applied (Ref. 143.Ref. 144.Ref. 122).  US water systems using ground water as 
source waters for drinking must operate in compliance with the US EPA Ground water Rule 
(GWR) (40 CFR Parts 141 and 142) to protect agai nst illness from waterborne pathogens in 229 
 
ground water.  However, the GWR does not address private wells because they are not under the 
jurisdiction of the Safe Drinki ng Water Act and are therefore not subject to EPA regulation .  
Thus, water quality and survey data on ground water used for agricu lture are not publicly 
available.  By their nature, surface waters are op en systems, subject to the influence of various 
environmental factors that can impact the safe ty of the water.  For example, increased 
precipitation levels, storm events, or wind may result in a spike in water turbidity, due to 
redistribution of sediments.  We tentatively conc lude that there exists significant potential for 
contamination of ground and surface waters and, th erefore, we propose to require you to include 
both ground and surface water sources in your inspec tion of your agricultural water systems. We 
seek comment on this tentative conc lusion and associated proposals.  
Proposed § 112.42(a)(2) requires you to consider th e extent to which you have control over your 
agricultural water s ource to identify conditions  that are reasonably li kely to introduce known or 
reasonably foreseeable hazards into or onto cove red produce or food-contact  surfaces.  You may 
have more control over your ground water source  (well) if it draws water from an aquifer 
beneath your property and which you protect from th e influence of surface act ivities.  You would 
likely have less control if your well is located near  a concentrated animal feeding operation or is 
influenced by surface water (e.g., a shallow well).   You may have greater access to and control 
of on-farm surface water sources such as impoundments, catches, and ponds, than you would for flowing surface waters that only course th rough but do not originate on your land.   
Proposed § 112.42(a)(3) requires you to consider the degree of protection of each agricultural 
water source.  Examples of prot ection for water sources include c overs, containments, or fencing 
that exclude domesticated animals or other pos sible sources of contamination from the water 230 
 
source or earthen berms or other barriers that help minimize the in fluence of runoff on the water 
source.   Proposed § 112.42(a)(4) requires you to consider  the use of adjacent or nearby land.  
Agricultural water may be affected by upstream  agricultural practices and runoff from those 
operations into surface water source s that you use.  For example, an upstream alfalfa grower may 
apply raw manure as a soil amendment, and irrigati on water runoff from that field may flow into 
your agricultural surface water source.  While  you may have little or no control of other 
agricultural water user practices , this proposed requirement to consider those nearby uses of 
which you are aware will help you determine appr opriate and safe use of that water source. 
Proposed § 112.42(a)(5) requires you to consider the likelihood of intr oduction of known or 
reasonably foreseeable hazards to agricultural water by another user  of agricultural water before 
the water reaches your covered farm.  For exam ple, if you use water from a river and are 
downstream from a waste water treatment plant that  discharges into that river, this provision 
would require you to consider the likelihood that  the wastewater treatment plant introduces 
hazards into the water before  it reaches your farm.  For example, you would consider the 
likelihood of accidental discharge of untreated  municipal sewage into the river.   
Proposed § 112.42(b) would requir e that you adequately mainta in all agricultural water 
sources that are under your c ontrol (such as wells) by regular ly inspecting each source and 
keeping the source free debris, trash, domestic ated animals, and other possible sources of 
contamination of covered produce to the ex tent practicable and appropriate under the 
circumstances.  Regular maintenance of your wate r sources is imperative to ensure the continued 
safety of your water.  Maintenance of on-farm water sources may include upkeep and repair of 
berms, pipes, liners, or any structural elements, that are used to protect the source.  Properly 231 
 
maintaining a well includes conducting wellhead  inspections, during which time you check the 
condition of the well covering, casing, and cap to make sure all are in good repair, leaving no 
cracks or other entry points for potential contam inants.  Properly maintaining a storage tank 
includes cleaning the interior surf aces of all rust scale, paint s cale, dirt, and bio-film forming 
growths and inspecting exterior surfaces for corrosion which may become a route of 
contamination (Ref. 31).  Properly maintaining a farm pond th at is used for irrigation using a 
direct application method, with re spect to keeping it free from dome sticated animals, could mean 
fencing the pond if you keep domesticated animals in  the area such that they would otherwise 
have access to the pond.  On the other hand, if you treat the water before use in this way, you 
may not need to take steps to prevent access of the domesticated animals to the pond.  This proposed provision should not be co nstrued to require the “taking”  of an endangered species, as 
the term is defined in the Endangered Species Act (16 U.S.C. 1532(19)) (i.e., to harass, harm, 
pursue, hunt, shoot, wound, kill, trap, capture, or co llect, or to attempt to engage in any such 
conduct). 
Proposed § 112.42(c) would require that you ade quately maintain a ll agricultural water 
distribution systems as necessary and appropriate to prevent the water distribution system from 
being a source of contamination to covered pro duce, food-contact surfa ces, areas used for a 
covered activity, or water sour ces, including by regularly inspec ting and adequately storing all 
equipment used in the system.  Regular main tenance of your agricultu ral water distribution 
system can be performed in conjunction with in spections and cleaning, as applicable.  If not 
regularly maintained, portions of a water distribu tion system may fail, corr ode, collect debris, or 
otherwise become a source of contamination.  For agricultural water distribution system 
components that are underground, it would be important to look for signs of erosion or wet soil 232 
 
areas, as they may indicate a damaged undergro und component requiring further inspection and 
maintenance (Ref. 145).   
Proposed § 112.42(d) would establish that you must immediately discontinue use of a 
source of agricultural water and/or  its distribution system, and not use the water source and/or its 
distribution system when you have determined or  have reason to believ e that your agricultural 
water is not safe and of adequa te sanitary quality for its inte nded use, until you either: (1) re-
inspect the entire agricultural water system unde r your control, identify any conditions that are 
reasonably likely to introduce known or reasonab ly foreseeable hazards into or onto covered 
produce or food-contact surfaces, make necessary ch anges, and test the wa ter to determine if 
your changes were effective and to ensure that y our agricultural water is safe and of adequate 
sanitary quality for its intended use; or (2) treat the water in accordance w ith the requirements of 
§ 112.43. Using agricultural water that  is not safe or of adequate sanitary quality for its intended 
use may lead to contamination of covered produce.  Lapses in sanitary quality of water can occur 
in any segment of a water system, from source to  point of use.  For example, if you find that 
water contains Salmonella  at the point where it would be used in a dump tank for tomatoes, it 
would not be safe or of adequate sanitary quali ty for that intended use.  As another example, 
your water would not be considered safe or of ad equate sanitary quality for its intended use if 
you found detectable generic E. coli  in a 100 ml water sample you obtained at the point where 
the agricultural water is used for washi ng produce as described in proposed § 112.44(a).  
Similarly, your water would not be considered sa fe or of adequate san itary quality if you found 
that test results exceeded 235 CFU per 100 ml generic E . coli  in a water sample you obtained 
from water used to overhead irrigate lettuce (a direct application method) as provided in 
proposed § 112.44(c).  We seek comment  on these proposed thresholds.  233 
 
Under this proposed provision in § 112.42(d )(1), for example, you would review your 
previous inspection results for the affected portion of your agricultural water system and 
compare those results to conditi ons you currently observe.  You would identify changes likely to 
have an impact on the quality of water (e.g., ev idence of runoff, animal  intrusion, suspended 
sedimentation, changes in adjacent land use) or a ny lapses in your procedures (e.g., outdated well 
inspection, break in the water tr eatment schedule).  You would test the water after you make 
changes you find necessary during your insp ection.  Under the proposed provision in § 
112.42(d)(2), you could instead choose to treat y our water in accordance with the requirements 
of § 112.43 to ensure its safety.  We tentativel y conclude that the measures proposed in § 
112.42(d) are necessary and adequate to address deficiencies that may exist in your water 
management system and practices so that your ag ricultural water does not  serve as a source of 
contamination to covered produce.  We welcome comment on this approach, as well as other 
actions that have been found to be eff ective through practi ce and experience.  
Proposed § 112.42(e) would establish that, as necessary and appropriate, you must 
implement measures reasonably necessary to redu ce the potential for cont amination of covered 
produce with known or reasonably foreseeable hazar ds as a result of pooling of water.  For 
example, such measures may include using prot ective barriers or staking to keep covered 
produce from touching the ground, or using an alte rnative irrigation met hod.  Pooling may occur 
if excessive water is applied to a crop, especially in areas of p oor drainage.  Pooled water that 
remains for extended periods of time has been sh own to increase likelihood of contamination  
(Ref. 10.Ref. 45).  Further, if pooled water is in close proximity to the crop, it may serve as an 
attractant for pests.  Mounding soil, staking, subsoil drip irrigation, dr ip tape or plasticulture (use 
of agricultural plastics) are methods that are used to reduce the potential for pooling or to 234 
 
separate the pooled water from the covered prod uce.  We acknowledge the potential for small 
pools of water to temporarily form in field areas or at the base of plants af ter irrigation.  Small 
amounts of water of this nature, which are temporar y and occur in the normal  course of irrigation 
practices, are not reasonably like ly to contribute to the contamin ation of covered produce.  We 
are not suggesting that it will always be po ssible to eliminate pooling.  Avoiding pooling by 
careful control of irrigation is ideal; however, ev ents such as rainfall or irrigation malfunction 
may sometimes make pooling inevitable.  In  those cases, the proposed requirement would 
require farms to take steps to protect covered pr oduce from contamination that may build in the 
pooled water.   
c. Requirements for treating agricultural water Water treatment is an effective means of d ecreasing the number of waterborne outbreaks 
in sources of drinking water 
(Ref. 146).  However, treatments that are inadequate or improperly 
applied, interrupted, or intermittent have been associated with waterborne disease outbreaks (Ref. 
146).  Failures in treatment systems are largely attributed to suboptimal particle removal and 
treatment malfunction (Ref. 147).   For this reason, when treating water, it is important to monitor 
the treatment parameters to ensure the treatm ent is delivered in an efficacious manner.  
Monitoring treatment can be performed in lieu of microbial water qualit y monitoring, if under 
the intended conditions of the trea tment, the water is rendered sa fe and of adequate sanitary 
quality for its intended use.  Many operations choose to perform microbial water quality testing 
in addition to monitoring the water treatment as a further assurance of treatment effectiveness 
(Ref. 148).   
Proposed § 112.43 would establish requirements related to treatment  of agricultural 
water.  Specifically, proposed § 112.43(a) woul d require that you must treat any agricultural 235 
 
water that you use (such as with  an EPA-registered antimicrobi al pesticide product) if you know 
or have reason to believe that the water is not safe and of ad equate sanitary quality for its 
intended use, whereas proposed § 112.43(b) woul d require that any method you use to treat 
agricultural water to satisfy this  requirement in paragraph § 112.43(a) must be effective to make 
the water safe and of adequate sanitary quality  for its intended use.  In addition, proposed § 
112.43(c) would require you to: (1) deliver any tr eatment of agricultural water required by § 
112.43(a) in a manner to ensure that the treated water is consistently safe and of adequate 
sanitary quality for its intended use; and (2) mo nitor any treatment of agricultural water at a 
frequency adequate to ensure that  the treated water is consistently safe and of adequate sanitary 
quality for its intended use.  
If you choose to use water that is not safe or of adequate sanitary qua lity for its intended 
use, the water must be treated before it is put to such use to minimize the likelihood for 
contamination.  For example, tr eating agricultura l water with antimicrobial compounds can be an 
effective means to eliminate pa thogens if done properly, includi ng under conditions that ensure 
the effectiveness of the active ingredient (Ref. 149.Ref. 150).  Any chemicals used in the 
treatment of water would require EPA registrati on under the Federal Insecticide, Fungicide and 
Rodenticide Act before they can be lawfully use d.  We note, however, that  at the present time, no 
such registration for chemical treatment of ir rigation water exists.  We anticipate that the 
proposed delayed implementation period for wate r quality testing (see section IV.K. of the 
document) would provide industry adequa te time to address such issues.   We seek comment on 
this issue.  
To ensure water treatment is delivered in an  effective manner, monitoring the conditions 
of treatment is also essential.  An effectiv e monitoring program woul d measure the level of 236 
 
active compound as well as those factors that may affect its activity, such as pH, temperature, 
and contact time.  For example, monitoring wa ter treated with hypochl orite in an orange 
postharvest wash would include, at  a minimum, monitoring the leve l of active antimicrobial (free 
available chlorine) and pH, since it is know n that hypochlorite activ ity is reduced both by 
organic material (e.g., soil, plant debris) and pH values outside its eff ective range (pH 6.0 – 7.5) 
(Ref. 149.Ref. 150).  The concentration of active disinf ectant and pH must be adjusted, as 
necessary, taking into account varia tions in water quality in order to  maintain the effectiveness of 
the treatment.  In addition, the frequency in whic h you monitor agricultural  water treatment must 
be adequate to ensure that the conditions for proper treatment are consistently met and adjusted, 
as necessary, to result in water that is safe and adequate for its intended use.  Research has shown that in other settings, monitoring of physical  parameters, such as temperature, pH and 
disinfectant concentration, can be done in real-time and in an inexpensive, automated manner, 
facilitating good cont rol of the process 
(Ref. 149).  As a verification that the treatment process, 
monitored in accordance with the proposed requirements of § 112.43(c)(2), is effective in 
achieving a certain microbial standard  (e.g., no detectable generic E. coli  in 100 ml of water), 
you may chose to perform periodic microbiological analysis of the treated agricultu ral water.  
We are not proposing at this time that treated wa ter must be tested in this manner because we 
believe that the effectiveness of various trea tment processes is well understood.  However, we 
encourage farms to perform such testing to provide  further assurance of the effectiveness of their 
treatment under the specific conditions that exist on their farm.  We s eek comment on this issue.     
d. Testing and frequency of te sting of agricultural water 
Proposed § 112.44 would establish requirements re lated to testing of  agricultural water 
and subsequent actions based on the test re sults.  Specifically, proposed § 112.44(a) would 237 
 
require that you test the quality  of agricultural wate r according to the re quirements in § 112.45 
using a quantitative, or presence-absence method of analysis provided in subpart N to ensure 
there is no detectable generic E. coli  in 100 ml agricultural water when it is: 
(1) Used as sprout irrigation water; (2) Applied in any manner that directly cont acts covered produce during or after harvest 
activities (for example, water that is applied to covered produce for washi ng or cooling activities, 
and water that is applied to harvested crops to prevent dehydration before cooling), including 
when used to make ice that directly contacts covered produce during or after harvest activities; 
(3) Used to make a treat ed agricultural tea;  
(4) Used to contact food-contact surfaces, or to make ice that w ill contact food-contact surfaces; 
or (5) Used for washing hands duri ng and after harvest activities. 
We seek comment on the appropriateness of these proposed categorie s in which testing 
would be required.  
Proposed § 112.44(b) would require that if you find that there is  any detectable generic E. 
coli in 100 ml of water, you must immediately di scontinue use of that source of agricultural 
water and/or its distribution system for the us es described in § 112.44(a) .  Before you may use 
the water source and/or distribut ion system again for the uses described in § 112.44(a), you must 
either re-inspect the entire agri cultural water system under your control, identify any conditions 
that are reasonably likely to introduce known or  reasonably foreseeable hazards into or onto 
covered produce or food-contact surfaces, make necessary changes, and retest the water to determine if your changes were effective and to en sure that the water meets the requirements of § 
112.44(a); or treat the water in accord ance with the requirements of § 112.43. 238 
 
We reviewed the most widely used indicator( s) or indicator groups for their potential in 
assessing the microbial quality of water used for purposes described in proposed § 112.44(a) and 
all other uses of agricultural water as descri bed in section V.E.2 of this document.  We 
considered total coliforms and fecal coliforms as indicators  of fecal contamination but 
determined that neither of them can serve as re liable indicators of a fecal contamination event 
(Ref. 124.Ref. 119.Ref. 151.Ref. 152).  Generic E . coli  is a member of both the coliform and fecal 
coliform groups but, unlike some members of t hose groups, it has been shown using various 
detection methods to be the only coliform cons istently associated with fecal contamination (Ref. 
132.Ref. 133.Ref. 134.Ref. 135.Ref. 136.Ref. 137.Ref. 108).  Generic E.  coli has an extensive 
history and support for use as an indicator of fecal contamination.  R ecently, it has emerged as 
the preferred indicator for monito ring water quality, not only becau se of the problems with other 
groups noted above, but also due to the developm ent of superior methods of detection with 
greater accuracy, sensitivity, and simp licity over those previously used (Ref. 119).  Despite 
widespread use and support for generic E.  coli as an indicator of fecal contamination, its ability 
to signal contamination events is not without  challenges.  Sampling frequency and location 
relative to the source of contamin ation are reported to affect the performance of generic E. coli  
as an indicator of fecal contamination (Ref. 133.Ref. 143.Ref. 153.Ref. 131).  Thus, non-detection 
cannot be considered absolute confirmation that fecal contamination has not occurred.  Further, 
the fate and transport of generic E . coli  takes different paths in different watersheds, and 
reservoirs have been identified, particularly se diments, where they may escape detection in the 
water column (Ref. 128.Ref. 129.Ref. 130.Ref. 154).  Nevertheless, based on our review of the 
literature, we tentatively c onclude that generic E. coli  serves as the most appropriate microbial 
indicator of fecal contaminati on of water at this time and, therefore, we propose to use a 239 
 
microbial standard of no detectable generic E. coli  in 100 ml agricultural wa ter when it is for the 
intended uses listed in § 112.44(a). We seek comme nt on our selection of this indicator.  
As discussed in the QAR, water used for the purposes listed in proposed § 112.44(a) has the 
potential to serve as a vehicle of pathogen contamination by direct  contact with covered produce.  
Water used in sprout production must be free of fecal contamination because the conditions 
under which sprouted seeds are produced (warm, moist, nutrient-rich environment for extended 
period of time) are conducive to pathogen multiplication (Ref. 14).  As discussed in section I.A. 
of this document, outbreaks associated with sprouted seeds are well documented; Salmonella  and 
E. coli  O157:H7 have been the major cause s of sprout-associ ated outbreaks (Ref. 14).  Similarly, 
the conditions under which agricultur al tea is produced (moist a nd nutrient-rich) are similar in 
that they support the multipli cation of pathogens, if present (Ref. 142).  Even a low number of 
pathogens introduced into or onto covered pr oduce through contaminated water could rapidly 
increase to levels that could pres ent risk of serious adverse health  consequences or death to those 
who consume the covered produce fo r which the tea was used.  Furt her, water that is used in 
direct contact with produce or food contact su rfaces, or in making ice that directly contacts 
produce or food contact surfaces, must also be free  of fecal contamination and pathogens.  These 
water applications normally occu r during or shortly after harvest,  leaving only a relatively short 
period of time before consumption for the enviro nmental factors that drive pathogen die-off to 
exercise a significant effect (s ee the QAR).  In addition, we propose to apply the microbial 
standard in proposed 112.44(a) to  agricultural water th at is intended for use in washing hands 
during harvesting, packing, and holdi ng activities, where there is li ttle opportunity for microbial 
die-off prior to consumption.  Ha nds that contact produce during a nd after harvest must be free 
of microbial contaminants (Ref. 133).  In the United States, the O ccupational Safety and Health 240 
 
Administration (OSHA) of the U. S. Department of Labor has established requirements for water 
used for washing workers’ hands.  Under 29 CFR 1928.110(b), a hand-washing facility means “a facility providing either a basin, container, or outlet with an adequate supply of potable water, 
soap and single-use towels;” and potable wate r means “water that meets the standards for 
drinking purposes of the State or local author ity having jurisdiction, or water that meets the 
quality standards prescribed by the U.S. EPA’ s National Primary Drinking Water Regulations 
[NPDWR] (40 CFR part 141).”  The OSHA requi rements in 29 CFR 1928.110 require that farms 
employing eleven or more employees engaged in hand-labor operations in  the field for a period 
of more than three hours in a day provide water that satisfies the microbial maximum 
contaminant level (MCL) in the NPDWR, which states that any generic E. coli
-positive repeat 
sample or generic E. coli -positive routine sample (which  would include a finding of any 
detectable generic E. coli  in 100 ml of water using the methods of analysis in proposed subpart 
N) constitutes a violation of the MCL for total co liforms.  Therefore, the microbial standard for 
hand washing water during harvesting, packing, and holding activities th at is specified in 
proposed § 112.44(a) would be consiste nt with the OSHA requirements. 
We acknowledge the difficulty of associating sp ecific indicator concen trations with specific 
produce related health risks.  Even so, we have  tentatively concluded th at such difficulty does 
not negate the value of applying generic E. coli  test results to the requirement to discontinue use 
of a water source until compliance w ith applicable generic E. coli  standard is again achieved, 
because elevated indicator organism concentr ations indicate increased levels of fecal 
contamination and elevated potential for the pr esence of human pathogens of fecal origin (Ref. 
154).  The uses listed in proposed § 112.44(a) ar e similar in that, if pathogens or fecal 
contamination are present, it is reasonably likely  they could be transfe rred directly to covered 241 
 
produce through direct or indirect (via food-contac t surfaces) contact with th e water.  Therefore, 
testing the agricultural water used for these purpos es to ensure that it is absent of generic E . coli  
would provide reasonable assura nces that the water does not c ontain pathogens, and therefore 
that the water is not likely to introduce pathogens into or onto covered produce and to provide 
reasonable assurances that the produce will not be adulterated under section 402 of the FD&C 
Act.  Moreover, a requirement that  there be no detectable generic E . coli  per 100 mL of 
agricultural water used in these activities and pr actices would be consistent with EPA’s MCLs 
for microbiological contaminants in public dr inking water systems (40 CFR 141.63(b)) and with 
our standard of quality for bottled water ( 21 CFR 165.110(b)(2)(B)).  We request comment on 
the need for, and appropriateness of, this proposed  requirement and any other criteria that would 
ensure the safety of water for these intended uses.   
We tentatively conclude that we should requ ire that if the water you use for the purposes 
listed in § 112.44(a) does not meet the microbi al standard of no detectible generic E . coli  per 100 
ml, you must immediately discontinue use of th e water and/or distribution system for those 
purposes.  Before you use the water source and/or  distribution system again for those uses, you 
would need to either (1) re-ins pect the entire agri cultural water system under your control, 
identify any conditions that are reasonably li kely to introduce known or reasonably foreseeable 
hazards into or onto covered pr oduce or food-contact surfaces, make necessary changes, and 
retest the water to determine if  your changes were effective and to ensure that the water meets 
the required microbial standard; or (2) treat the water in accordance with the requirements of § 
112.43 (proposed § 112.44(b)).  This proposed require ment is parallel to the requirement in 
proposed § 112.42(d), which is discussed above.    242 
 
Proposed § 112.44(c) would require that when agricultural water is used during growing 
activities for covered produce (other than spr outs) using a direct wa ter application method, you 
must test the quality of water in accordance with  one of the appropriate analytical methods in 
subpart N.  If you find that there is more than 235 colony forming units (CFU) (or most probable 
number (MPN), as approp riate) generic E. coli  per 100 ml for any single sample or a rolling 
geometric mean (n=5) of more than 126 CFU (or MPN, as appropriate) per 100 ml of water, you 
must immediately discontinue use of that source of agricultural water and/or its distribution 
system for the uses described in § 112.44(c).  Before you may use the water source and/or 
distribution system again for the uses describe d in § 112.44(c), you must either re-inspect the 
entire agricultural water system  under your control, identify any conditions that are reasonably 
likely to introduce known or reasonably foreseea ble hazards into or onto covered produce or 
food-contact surfaces, make necessary changes, and retest the water to determine if your changes 
were effective; or treat the water in accord ance with the requirements of § 112.43. We seek 
comment on this approach.  
As discussed in section V.E.2. of this  document, the WHO recommends monitoring 
generic E. coli  numbers in treatment effluents as ve rification of wastewater treatment, and 
laboratory analysis of crop contamin ation levels with generic E. coli  at harvest and in retail to 
verify pathogen mortality (die-off) (Ref. 118).  However, they also noted the variability in 
pathogen die-off (0.5 – 2 log/day) , dependent on temperature, sun light intensity, crop type, time 
of water application, and other factors.   
Some industry groups have a dopted the generic E. coli  component of the US EPA 
recreational water standard s (for beaches used frequently) for certain uses of agricultural water 
(Ref. 31.Ref. 44).  In this regard, EPA recommends that  criteria include a maximum steady state 243 
 
geometric mean of 126 CFU of generic E. coli  per 100 ml and a single sample maximum 
allowable density of 235 CFU of generic E. coli  per 100 ml (Ref. 136).  British Columbia, 
Canada has announced their inte ntion to use generic E. coli  criteria for irrigation water used on 
produce consumed raw.  Their irrigation criteri a (less than or equal to 77 CFU per 100 ml 
geometric mean) are the same as and were de rived from those used for primary-contact 
recreation (Ref. 137).  Similarly, the generic E. coli  component of EPA’s recreational water 
standard (for beaches used frequently) serves as  the basis for our proposed standard for microbial 
water quality for water used in direct appl ication methods during growing (proposed § 
112.44(c)).   
It should be noted that EPA’s recreational wa ter standards for beaches used frequently 
also includes a recommendation for a maximum steady state geometric mean of 33 CFU of 
enterococci per 100 ml and a single sample maximum allowable density of 61 CFU of 
enterococci per 100 ml (Ref. 136).  Similarly, the current British Columbia criteria for irrigation 
water used on produce consumed raw is a geometri c mean of less than or equal to 200 CFU fecal 
coliform per 100 ml and they have announced thei r intention to use a geometric mean of less 
than or equal to 20 CFU enterococci pe r 100 ml (along with generic E. coli,  as discussed above).  
We have tentatively concluded to not include enterococci or fecal co liform in our proposed 
standard at § 112.44(c) because we believe generic E. coli  to be the superior  indicator of fresh 
water quality and do not believe that the adde d cost of testing for both generic E. coli  and 
enterococci is warranted.  Wade et al (2003) (Ref. 155) performed a systematic review of 27 
studies of water quality indicators used for the re gulation of recreational waters.  They compared 
the ability of enterococci, fecal coliform, generic E. coli  and total coliform levels to predict for 
the occurrence of gastrointestinal illness.  They  concluded that for freshwater, generic E. coli 244 
 
was the more consistent predictor.  Working under the framework of a WHO project for setting 
guidelines for quality of recreational wa ters and bathing beaches, Pruss (1998) (Ref. 156) 
reviewed 22 studies on uncontrolle d waters (seas, lakes, and rivers ) for dose-related relationships 
between GI illness and bacterial indi cator (most commonly generic E. coli , enterococci, and fecal 
coliforms) counts.  The author found the two in dicator organisms which correlate best with 
health outcomes were enterococci for both marine and freshwater and generic E. coli  for 
freshwater.   We considered proposing a drinking water standa rd for water used on covered produce other 
than sprouts during growing in a direct water ap plication method, but tentatively conclude that 
such criteria would be unnecessa rily restrictive as it would not sufficiently account for forces 
driving pathogen die-off (e.g., sunlight, competi ng microorganisms) (see section V.E.2 of this 
document).  We also considered proposing a second lower microbial quality criteria for water 
used in growing, but where the water used for i rrigation is not reasonably  likely to contact the 
edible portion of the covered pr oduce (e.g., surface irri gation of tree crops).  However, we are 
not aware of another standard for which there is sufficient scientific support. 
We acknowledge that the EPA recreational water standards were developed from 
epidemiological studies that correlated the risk of  gastrointestinal illnes s to exposure to marine 
and freshwater by swimmers 
(Ref. 136), rather than to consum ption of produce.  These 
epidemiological studies were performed in beach areas subject to point source fecal 
contamination rather than non-point  sources (e.g., birds, agricultu ral and livestock runoff), which 
may impact agricultural water.  Further, risks of adverse health outcomes resulting from full 
body contact in contaminated water may be diff erent than risks associated with consuming 
produce irrigated with contaminated water, give n the differences in th e expected routes of 245 
 
infection and pathogen mortality ra tes in the different environments  (bodies of water for the EPA 
recreational water standards; soil, plants, and produce fo r this proposed rule).   
We also acknowledge that the proposed sta ndard is more stringent than the WHO 
standard.  Based upon an analysis of tolerable risk for irrigation wate r, WHO recommends that 
the minimum microbial quality for water used on  root crops that are eaten raw is 1000 CFU 
generic E . coli  per 100 ml (10,000 CFU generic E. coli  per 100 ml in leaf crops) (Ref. 118.Ref. 
120).  According to the WHO analysis, using water of this microbial qual ity is dependent upon a 
2 log reduction due to die-off between last irri gation and consumption (includes die-off in the 
field and during distribution) and a 1 log reduction attributed to washing prior to consumption.  
This analysis recognizes the variable nature of  die-off values, ranging from 0.5 – 2.0 log per day 
(Ref. 118).  The WHO analysis considers the need fo r a four log reduction through dilution, die-
off, or treatment between the levels of generic E.coli  in raw sewage (well represented in sewage 
by fecal coliform levels) and the levels in irriga tion water used on root crops that are eaten raw 
(3 log for leaf crops), in addition to the 3 log reduction discussed above.   
We tentatively conclude that the recreational water generic E. coli  criteria would serve to 
minimize risk of known or reasonably foreseeable hazards when used as a standard for agricultural water used on pr oduce other than sprouts during growing in a direct water 
application method.  We recognize that is some what more protective than the WHO standard, 
which we believe is appropriate given the uncerta inty in die-off values.  We request comment on 
the need for, and appropriateness of, this requir ement or other criteria that would ensure the 
quality of agricultural water used for this purpose.    
We tentatively conclude that if agricultu ral water you use on produce other than sprouts 
during growing in a direct a pplication method does not meet  the microbial water quality 246 
 
described in § 112.44(c), you must im mediately discontinue use of that source of agricultural 
water and/or its distribution system and either  (1) re-inspect the agricultural water system 
components under your control, identify conditions  that are reasonably likely to introduce 
hazards to the system, make necessary change s based upon your observations, and retest the 
water to determine if your changes were effective;  or (2) treat the water in accordance with the 
requirements of § 112.43.  This proposed requireme nt is parallel to the requirement proposed § 
112.42(d), which is discussed above.    
We tentatively conclude that violation of microbial water quality standards proposed in 
§§ 112.44 (a) and (c) in and of itsel f would not necessarily establis h evidence of adulteration of 
covered produce subjected to use of the water, nor would it necessarily mean that the food was 
contaminated.  However, use of water that is sh own to violate these standards would violate the 
requirement at proposed § 112.41 that all agricultu ral water must be safe and of adequate 
sanitary quality for its intended use.  As desc ribed immediately above, these proposed standards 
are based on likelihood of fecal contamination (a s indicated by the presence of generic E. coli ), 
that we have tentatively concluded minimize the ri sk of serious adverse health consequences or 
death by preventing the introduction of hazards and providing reasonable assurances that 
produce is not adulterated under section 402 of the FD &C Act.  Agricultural water in violation of 
these standards indicates increased likelihood of fecal contamination of the water and, 
consequently, increased likelihood of produce co ntamination with human pathogens, beyond that 
which is appropriate for the intended use. Ther efore, we propose to require you to immediately 
discontinue use of that source of agricultural wa ter and/or its distribut ion system until you have 
either followed certain prescribed steps to mitigate the problem or treated the water.  247 
 
Under the provisions of proposed § 112.44, if covered farms choose to treat irrigation 
water in accordance with the requirements of  proposed § 112.43, any chemicals used in such 
treatment would require registra tion under the Federal Insecticid e, Fungicide and Rodenticide 
Act before they can be lawfully used.  At th e present time, no such registration for chemical 
treatment of irrigation water exists.  As discu ssed in section IV.K. of this document, FDA is 
proposing to delay implementation of certain pr ovisions, including the water quality testing 
requirements in proposed §112.44, beyond the effective dates for other provisions of the rule.   
The proposed extended compliance dates for the water quality testing, m onitoring, and related 
record keeping requirements in proposed §§ 112.44, 112.45, 112.50(b)(5), 112.50(b)(6), and 112.50(b)(7) are six years from the e ffective date for very small businesses, five years from the 
effective date for small businesses, and four y ears from the effective da te for all other farms 
subject to the rule.  We expect  these extended compliance dates to provide adequate time for 
industry to address issues relate d to water quality testing. We s eek comment on the adequacy of 
this timeline.  
Proposed § 112.44(d) would also allo w you to establish and use altern atives to the requirements 
established in proposed § 112.44(c)  provided you satisfy the re quirements of proposed § 112.12.  
As discussed in section V.B. of this documen t, under proposed § 112.12(a)(1), you may establish 
an alternative to the requirements, established in proposed  § 112.44(c) for testing water, and 
taking action based on test results when agricultur al water is used during growing operations for 
covered produce (other than sprouts) using a direct water applicati on method.  We acknowledge 
that in specific circumstances an  alternative standard (e.g., a standard that applies an application 
interval (time between applica tion and harvest) in place of the § 112.44(c) standard, but is 
specific to a specific commodity or commodity group and region) may be appropriate if the 248 
 
alternative standard is shown to provide the same level of public he alth protection as the standard 
in proposed § 112.44(c) and not to increase th e likelihood that the covered produce will be 
adulterated.  Therefore, we tentatively conclu de that it would be a ppropriate to allow for 
alternatives to the require ments in proposed § 112.44(c). 
We are working with USDA and other stakeholders  to facilitate research into application 
intervals that would be commodity- and region -specific, such that water not meeting the 
proposed § 112.44(c) standard could be used in a direct water applicat ion method for growing 
covered produce other than sprouts as long as it was applied before the start of the scientifically 
established application interval (i .e., at a certain number of days before harvest or earlier).   
Proposed § 112.45 would establish requirements re lated to frequency of testing agricultural 
water that is subject to the requirements of § 112.44.  Specifically, proposed § 112.45(a) would 
require that you test any agricultu ral water that is subject to the requirements of § 112.44 at the 
beginning of each growing season, and every thr ee months thereafter during the growing season, 
except that there would be no re quirement to test water when: 
(1) You receive water from a Public Water Sy stem, 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 re gulations of a State approved to administer 
the SDWA public water supply program, and yo u have Public Water System results or 
certificates of compliance that demonstrat e that the water meets that requirement; 
(2) You receive water from a pub lic water supply that furnishes water that meets the microbial 
requirement described in 112.44(a), and you have public water system  results or certificates of 
compliance that demonstrate that the water meets that requirement; or (3) You treat water in accordance with the requirements of § 112.43.  249 
 
Water testing frequencies recommended by variou s industry documents vary widely, in part 
because there is a lack of public ly available information pertaini ng to the quality of irrigation 
waters.  Recommendations range from monthly testing to once each year, for sources with a 
history of compliance with co mmodity specific recommendations (Ref. 31.Ref. 44).  Even for 
sources considered reliable (e .g., well water), a one year pe riod between testing does not 
minimize the risk of known or reasonably fo reseeable hazards because microbiological water 
quality, even when sourced from ground water sour ces, is too variable for this frequency of 
testing to be protective (e .g., effects of flooding, runoff) (Ref. 29).  Alternatively, we tentatively 
conclude testing more frequently (less than ev ery 3 months) would not significantly improve the 
accuracy of your assessment of ground water qual ity and would therefore be unnecessary.  We 
also considered proposing testi ng frequencies established as a function of commodity, irrigation 
method (e.g., furrow, seep, subsurface dripfolia r), and timing of appli cation (days prior to 
harvest), and concluded that the most effective a pproach is to test on a frequency related to the 
reliability of the agricultural water sources.  We tentatively conclude that requiring testing as a 
function of time before harvest would be imprac tical for many farms as we have observed single 
sources (e.g., a well) providing water for multiple  crops in different phases of production.  We 
request comment on whether we should allow for adjustment of ground water testing frequencies 
dependent upon historical test results.  For ex ample, we are consider ing requiring testing ground 
water sources every three months for one year  and yearly after that if the ground water 
consistently met the standard.  We also reque st public comments on our proposed approach to 
frequency of testing, each of the options desc ribed here, and any othe r alternative testing 
frequencies that can be suppor ted by water quality data.   250 
 
Proposed § 112.45(a)(1) provides an exception to test ing required in § 112.45(a) when the water 
is sourced from a Public Water System or St ate authority approved to  administer the SDWA 
public water supply program, and you have result s of the water testing or certificates of 
compliance that demonstrate that the water meets the requirements of that program.  These systems operate so that the water they deliver meets the microbial requirement in 112.44(a).  In 
the U.S., Public Water Systems are required und er U.S. EPA National Primary Drinking Water 
Regulations (NPDWR) in 40 CFR 1 41 to provide safe, clean water suitable for drinking and thus 
are at the lowest likelihood fo r pathogen contamination.   Under the sampling, testing and 
reporting requirements of 40 CFR 141, we tentatively conclude that additional actions by the 
grower to assure its safety are unwarranted.  Similarly, proposed § 112.45(a)(2) provides for an 
exception to testing when the water is furnished from a public water supply that furnishes water 
that meets the standards of § 112.44( a), and you have results of the wa ter testing or certificates of 
compliance that demonstrate that the water meets that standard.  The standard in § 112.44(a) is 
derived from the EPA drinking water standard, and this provision is included to accommodate 
foreign public water supplies that are not govern ed by the requirements of the EPA drinking 
water program, but provide water of a quality that meets the micr obial requirement of proposed § 
112.44(a).  Where public water that  meets or is comparable to  (in other countries)  EPA’s 
drinking water standards is used in produce opera tions, we are not aware of anything suggesting 
a need for additional testing at its delivery point to the farm.  We seek comments on this issue, including any practice(s) that co uld materially change the qualit y of public or municipal water 
between treatment and delivery to the farm, in cluding changes in water quality during water 
distribution and holding.  Finall y, § 112.45(a)(3) exempts from te sting water that you treat in 
accordance with proposed § 112.43, which is discussed above. 251 
 
Proposed § 112.45(b)(1) would es tablish that if you use unt reated surface water for 
purposes that are subject to the requirements of proposed § 112.44, and if the untreated surface 
water is from any source where a significant quantity  of runoff is likely to drain into the source 
(for example, a river or natural lake), then you must test the water at least every 7 days during 
the growing season.  Proposed § 112.45(b)(2) would establish that  if you use untreated surface 
water for purposes that are subj ect to the requirements of pro posed § 112.44, and if the untreated 
surface water is from any source where  undergr ound aquifer water is transferred to a surface 
water containment constructed and maintained in  a manner that minimizes runoff drainage into 
the containment (for example, an on-farm man- made water reservoir), then you must test the 
water at least once each mont h during the growing season.  
Surface water is subject to a great number of e nvironmental factors that may alter its microbial 
water quality as discussed in the QAR and, when untreated, presents a si gnificant source of 
pathogen contamination of produce.  We tentat ively conclude that the most important among 
these is runoff, because it has the potential to increase the number of pathogens in the water 
column if its origins include human, livestock or wildlife feces and because it has the potential to 
increase the amount of suspended sediment s, which are likely to harbor pathogens (Ref. 157.Ref. 
154).  In proposing these testing frequencies, we te ntatively divided untrea ted surface water into 
two categories based upon their potential to be impacted by ru noff and the degree to which you 
reasonably could be expected to exercise pr otection and control over them.  Flowing surface 
waters (e.g., river, stream, or creek) or sources that are not pr otected against runoff (e.g., natural 
ponds, lakes) must be tested at a relatively hi gher frequently than surface waters for which you 
have direct control and which you can manage in a way so to minimize the effect of runoff and 
other sources of contamination (e.g., on-farm reser voir or pond).  Contamination events that can 252 
 
lead to surface water contamination can have profound effects on the quality of the water, but 
those effects can be fleeting, especially those in volving runoff from rainfall (several days to 
several weeks).  After the contamination even t passes, water quality generally returns to 
background levels (Ref. 158).   If sampling is less frequent than weekly from surface water 
sources subject to these kinds of contamina tion events, there is a good chance that some 
contamination events will go undetected.  On th e other hand, for surface water sources that are 
not subject to significant runoff, the water qualit y tends to remain stable, and the purpose of 
sampling is primarily to accurately characte rize the background level.  Monthly sampling 
provides 12 samples per year that give a good repr esentation of the quality of water through the 
seasons. The sampling and testing frequencies pro posed in § 112.45(b) are the minimum that we 
tentatively conclude provide sufficient informa tion concerning your source surface water quality 
for you to use in determining method of applicati on and its timing for which the water is safe and 
of adequate sanitary quality.  We encourage ad ditional sampling if you ha ve reason to believe 
that its quality may have changed from the pr evious test.  We welcome comments on the need 
for, and appropriateness of, our proposed tes ting frequencies, incl uding any alternative 
approaches and examples where testing should be more or less frequent based upon your 
experience or observation. The monitoring frequencies proposed in this rule  are practical interval s that we tentatively 
conclude are reflective of the varying potenti al for changes in water quality between ground 
aquifers and surface watersheds.  In proposing th e monitoring frequencies for untreated surface 
waters, we considered factors th at are most likely to impact wa ter quality.  Precipitation and its 
effects (e.g., discharge and flow  rate) along with temperature ar e common factors reported to 
affect the microbial quality of wate rsheds with agri cultural land inputs 
(Ref. 159.Ref. 158).  253 
 
Precipitation levels have also been successfully  used to manage openings and closings of 
molluscan shellfish harvest areas.  These harvest areas are well characterized  in terms of changes 
in the microbial water quality due to non-point source runoff as a consequence of rainfall.  
However, we have not proposed surface water testing frequency based upon precipitation because such an approach would requir e full characterizatio n of its effects 
(Ref. 143) on the 
quality of surface water sources that are not likely to be generally useful across farms, States, or 
regions.  Our approach to testing untreated surf ace water is to propose practical intervals of 
testing both because they are likely to capture transient events that may degrade quality and 
because they are useful regardless of geogra phic location.  We welcome comments on this 
approach, including any alternate approaches, speci fically if you believe th at surface waters can 
be thoroughly characterized such  that they require less freque nt testing than proposed in § 
112.45. e. Requirements for water used in ha rvesting, packing, and holding activities 
Proposed § 112.46 would establish the measures  you must take for water that you use 
during harvest, packing, and holdi ng activities for covered produ ce.  Specifically, proposed § 
112.46(a) would require that you manage the wate r as necessary, including by establishing and 
following water-change schedules fo r re-circulated water, to maintain adequate sanitary quality 
and minimize the potential for contamination of covered produce and food-contact surfaces with 
known or reasonably foreseeable hazards (for example, hazards that may be introduced into the water from soil adhering to the covered produc e).  The proposed language allows sufficient 
flexibility for you to establish m easures that are best suited to  your needs based on practice and 
experience.  For example, you may establish a wa ter-change schedule for water used in an apple 
flume based upon the rate of product flow, organi c load, or other variables you determine best 254 
 
correlate with safety and sanitary quality of the flume water.  Many commonly used wash water 
antimicrobials have decreased efficacy when or ganic matter is present in the water.  For 
example, organic matter builds up in  agricultural water flume system s from dirt and debris on the 
surface of fresh produce that are placed into the flume systems.  On ce the soluble and/or 
insoluble organic load builds up to sufficien tly high levels, the addition of wash water 
antimicrobials becomes ineffective and inefficient.   Changing the flume water on a regular basis, 
based on that system’s unique operating conditions , can assure that wash water disinfection 
treatments are consistently effective (Ref. 149.Ref. 150).We point out that while water 
disinfection is one means to manage water qualit y, we are not specifica lly proposing to require 
disinfection treatment of re-circulated or single us e water that is used in harvesting, packing, or 
holding activities.  We are proposin g that re-circulated or single pass water must be safe and of 
adequate sanitary quality for its intended use (§ 112.41) and th at it contain no detectable E . coli  
(§ 112.44(a)).  Further, if you have reason to believ e that the water is not safe and of adequate 
sanitary quality for its intended use, proposed provisions in § 112.43 for water treatment can be 
applied.  However, we are not proposing treatment of water as the only option.  Other options for 
farms include making changes to the system and retesting the water suc cessfully (§ 112.42(d)) 
and using the same water source for other uses fo r which it does qualify.  For example, using 
water that does not meet the zero E. coli standard but does meet the 235 CFU per 100 ml 
standard for direct application method irrigation of produce other th an sprouts; or for water that 
does not meet the 235 CFU per 100 ml standard, a pplying the water for irri gation in a different 
manner that is not a direct a pplication method (§ 112.44).  These provisions offer flexibility for 
farms to choose among different options to ensure that the water is safe and adequate for the 
purpose for which it is intended.  Should farms choos e to disinfect water as a measure to control 255 
 
waterborne hazards during handling during and afte r harvest, we tentatively conclude that an 
effective disinfection program would render such wa ter safe and of adequa te sanitary quality.  
However, we request public comment on the appr opriateness of this te ntative conclusion and on 
whether a provision specifically dire cted to disinfection of water us ed during and after harvest is 
needed.  We also seek public input regarding practices or conditions when disinfection of re-
circulated or single use water would be unn ecessary, inappropriate, or impractical.   
Proposed § 112.46 (b) would require that you visu ally monitor the quality of water that 
you use during harvest, packing, and holding activ ities for covered produce (for example, water 
used for washing covered produce in dump tanks , flumes, or wash tanks, and water used for 
cooling covered produce in hydrocoolers) for build- up of organic material (such as soil and plant 
debris).  Organic matter such as soil and plant de bris has to the potential to adversely affect the 
quality of water; it may be a source of bacter ia (including pathogens), support the growth of 
bacteria, and reduce the effectiveness of an timicrobial compounds (e.g., chlorine compounds) 
(Ref. 150).  Such monitoring allows you to recognize conditions that require action, such as a 
water change in a dump tank. 
Proposed § 112.46 (c) would require that you 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.  Water temperature can 
influence processes leading to infiltration of microorganisms into many types of produce.  As 
discussed in the QAR, infiltration of water containing pathogens into produce has been 
demonstrated in apples (Ref. 160), oranges (Ref. 161), tomatoes (Ref. 138.Ref. 139), and mangoes 
(Ref. 38) and was suggested to play  a role in a 1999 Salmonella  outbreak associated with mangos 256 
 
(Ref. 162).  A recent study demonstrated that additional factors, such as tomato variety and the 
time delay between tomato stem removal and wate r immersion have a significant impact on the 
frequency and population of internalized Salmonella in tomatoes. (Ref. 140)  However, this study 
also demonstrated that Salmonella  internalization of tomatoes via their stem scar can occur even 
under a zero temperature differential, and temperature differentials up to 10oF have no effect on 
the internalization frequency and have limited impact on Salmonella  cell populations internalized 
in tomatoes.   
We considered proposing a single standard on temperature differential between water and 
product core temperature (e.g., water must be at  least 10 degrees F warmer than core) but 
tentatively conclude that there is insufficient scien tific evidence supporting such a standard 
across all covered produce.  Howe ver, we recognize the North American Tomato Trade Work 
Group and California Tomato Commission have recommended such a standard (Ref. 44).  We 
seek public comment on the need for, and approp riateness of, the proposed  provisions, including 
any alternative approaches that you found to be  effective through experience or observation.   
f. Records requirements Proposed § 112.50 would establish requirements a bout the records that you would need to 
establish and keep under this proposed subpart  E.  Specifically, pr oposed § 112.50(a) would 
require that you establish and keep records requi red under this proposed subpart E in accordance 
with the requirements of proposed subpart O.  Proposed § 112.50(b) would require that you 
establish and keep the following records: (1) The findings of the inspection of your agricu ltural water system in accordance with the 
requirements of proposed § 112.42(a);   257 
 
(2)  Documentation of the results of any anal ytical tests conducted to determine whether 
agricultural water is safe and of adequate sanitary quality for its intended use;   
(3)  Scientific data or information you rely on to support the adequacy  of a method used to 
satisfy the requirements of § 112.43(b) and (c)(1); (4) Documentation of the results of wate r treatment monitori ng under § 112.43(c)(2); 
(5) Documentation of the results of water testin g you perform to satisfy the requirements of § 
112.44;  (6) Scientific data or information you rely on to support any alternativ e to the requirements 
established in § 112.44(c) for agricultural water used during growing activ ities using a direct 
water application method in accordance with the requirements of § 112.44(d); and (7) Annual documentation of the re sults or certificates of compliance from a public water system 
under 112.45(a)(1) or (2 ), if applicable. 
Proposed § 112.50(b)(1) would require that you esta blish and keep records of agricultural 
water system inspection findings in order for FDA to verify compliance with the proposed 
requirement to inspect the agricultural water syst em.  The records would also allow you to more 
effectively manage your agricultur al water, to identify trends a nd changes in your agricultural 
water system over time, and to help identify potential sources of contamination of the water 
system and covered produce.  In addition, thes e records may aid you in determining the most 
appropriate frequencies for maintenance of we ll and surface water sour ces, distribution and 
holding systems.   
Proposed § 112.50(b)(2) would require that you establish and keep records of any 
analytical test results from any tests you may have conducted to  determine if water meets the 
quality requirements proposed in  § 112.41.  We have tentatively concluded that  these records 258 
 
are necessary because otherwise FDA would have no way to determine whether you were 
making appropriate decisions about whether your wate r is safe and of ade quate sanitary quality 
for its intended use.  When such tests are conducte d, results of those tests are also fundamental in 
making informed decisions concer ning your use of water.    
We are proposing under §§ 112.50(b)(3) and (4 ) that you must establish and keep 
scientific information or data documenting the e ffectiveness of the treatment method that you use 
and records demonstrating that you deliver the treatment consistently  to ensure the water is safe 
and of adequate sanitary quali ty.  These records may include information provided by the 
antimicrobial product supplier, prod uct labels with instructions for use, product material safety 
data sheets (MSDS), batch test results demons trating correct active i ngredient concentration, 
mixing proportions, and schedules or  application rates you have de veloped to ensure water is 
treated effectively.  They may also include results of testi ng you perform to confirm your 
treatment methods are being followed, such as re cords of active ingredient concentration, pH, 
temperature, flow rate, immersi on time, or water changes, if they significantly impact the 
effectiveness of the treatment.  Monitoring fr equency may be affected by product flow, organic 
load on incoming product, temperature, UV exposur e, and consumption rates or breakdown rate 
(expected and observed) for the active antimic robial compound, among other factors.  These 
records are necessary so that FDA can verify yo ur compliance with those requirements.  They 
will also allow you to ensure your own compliance with the requirements for water treatment in 
proposed § 112.43. 
We are proposing in § 112.50(b)(5) that you must establish and keep records of the 
results of water testing you perform to satisfy the require ments of § 112.44.  For example, 
records for water tests you perform to ensure input water used in sprout production meets the 259 
 
requirements in § 112.44(a) would include, at a mi nimum, the test date, specific water source 
(e.g., municipal water or well number 3), me thod name (e.g., multiple tube fermentation, 
membrane filter method, presence-absence test, a nd commercial product name, if applicable) and 
the test result (e.g., not detected, generic E . coli MPN or CFU, as applicable).  Records you 
maintain to demonstrate the microbial water quality meets the requirements of § 112.44(c) for 
foliar application of spinach woul d include, at a minimum, the test  date, specific water source 
(e.g., ranch X, well 3 or canal collection point 2), method name (e.g., multiple tube fermentation, 
membrane filter method, and commercial product name , if applicable) and the test result (e.g., E . 
coli MPN or CFU, as applicable).   We tentativel y conclude that documentation of the results of 
water testing are necessary to demonstrate that the water you use meets the requirements of § 
112.44 and to provide a history of the microbial quality of your water system, which will be 
useful in spotting problems before they occur, mi nimizing the potential for water to be a source 
of contamination to covered produce.   These re cords are necessary so that FDA can verify your 
compliance with those requirements and so that  you can ensure your own compliance with the 
requirements for water testing and res ponding to test results in proposed § 112.44. 
In proposed § 112.50(b)(6), we would require you to establish and keep that scientific data or 
information you rely on to support any alternativ e to the requirements established in § 112.44(c) 
for agricultural water used during growing activi ties using a direct water application method in 
accordance with the requirements of § 112.44(d).  Such documentati on will enable us to verify, 
and you to ensure, that the alternative standard you use provides the same level of public health 
protection as the standard in proposed § 112.44(c)  and does not increase the likelihood that the 
covered produce will be adulterated, in accordance with proposed § 112.12. 260 
 
We are proposing in § 112.50(b)(7) that if you use water from a public water system, you 
must establish and keep annual documentation (e.g., certificate of compliance, water quality 
testing results) demonstrating th at system supplies water meeting the microbial requirements of § 
112.45(a)(1) or (2), if applicable .  We tentatively conclude th at maintaining such annual 
documentation is necessary for FDA to verify that the water you use is not subject to the 
requirements for testing under proposed § 112.45 and to ensure that it meets the microbial 
requirements of proposed 112.44, and for you to dem onstrate that those re quirements have been 
met. We seek comment on the appropriateness of the proposed record-keeping requirements.  
 
F. Subpart F -- Standards Directed to Biologi cal Soil Amendments of Animal Origin and 
Human Waste  
Proposed subpart F establishes st andards directed to treated and untreated biological soil 
amendments of animal origin and human wa ste.  These standards include requirements 
applicable for determining the st atus of a biological soil amendmen t of animal origin; procedures 
for handling, conveying, and storing biological soil amendments of animal origin; provisions 
regarding the use of human wast e in growing covered produce; acceptable treatment processes 
for biological soil amendments of animal orig in applied in the growing of covered produce; 
microbial standards applicable to treatment pr ocesses; application requirements and minimum 
application intervals; requirements specific to agricultural teas; and records requirements.  The 
proposed requirements in subpart F derive from  current recommendations in our GAPs guidance 
(Ref. 10), commodity-specific guidances (Ref. 31)(Refs. LGMA), State regulations (Ref. 90.Ref. 
163.Ref. 164), other Federal Regulations ( 40 CFR 503, 7 CFR 205), and international guidelines 
(Ref. 100.Ref. 51).   261 
 
1. Comments Relevant to  Proposed Requirements 
We received several comments in response to th e 2010 FR notice that addressed issues relevant 
to biological soil amendments of an imal origin and human waste.   
a. Definitions One comment stated that manure and compost are two different things, and the two words should 
not be used interchangeably as it causes confus ion.  We agree. As discussed in the QAR, and 
noted in the Produce Safety Project Issue Brie f on Composting of Animal Manures there are 
documented differences in the populations and le vel of human pathogens in raw manure and 
animal feces and in properly composted manure 
(Ref. 27).  We are proposing definitions that 
make the distinction clear.  We are proposi ng to use the phrase “untreated biological soil 
amendments of animal origin” as a category that includes raw manure (see proposed § 112.3(c) 
and section V.A.2.b.iii of this document regarding “biological soil amendmen t of animal origin,” 
and proposed § 112.51(a) and section V.F.2.a of th is document regarding “untreated” biological 
soil amendments of animal origin). We use th e term “treated biological soil amendments of 
animal origin” to include treatments that meet th e requirements of the standards presented in this 
subpart (see proposed § 112.51(a) and section V.F.2.a of this document).  To further alleviate 
confusion, we use the term “compost” as a verb, to mean the act of composting, and do not use it as a noun to describe a soil amendment that wa s treated by a composting method.  Instead, we 
use the term “humus” in its common agricultu ral meaning (see proposed § 112.3(c) and section 
V.A.2.b.iii of this document). b. Consideration of other regulations and guidances 
Comments from growers whose ope rations are certified for orga nic produce requested us to 
ensure that our regulations do not  interfere with existing organic certification systems or organic 262 
 
production practices.  Another comment stated that the California code of regulations for 
composting yards  (Cal. Code Regs. title. 14, ch. 3.1) w ould be an acceptable starting point in 
developing our regulations.  We consider that organic producti on practices and food safety are not cross-competing goals.  In 
developing the provisions proposed in this rule , we consulted with technical experts and 
representatives from other Federal Agencies, including the Environmental Protection Agency, 
the Department of Agriculture (including both the National Organic Program and the Natural 
Resources Conservation Service), and the Departme nt of the Interior (Fish & Wildlife Service) 
(Ref. 115).  As discussed in section III.A.8. of this document, we tentatively conclude that 
compliance with the provisions of this proposed  rule would not preclude compliance with the 
requirements for organic certification in 7 CFR pa rt 205, and we seek comment on this tentative 
conclusion.  Use of organic practices  alone is not sufficient to ensu re food safety.  The use of raw 
manure at a time close to harvest, during or ganic or conventional production, presents a 
significant likelihood of contamination of covere d produce if produce is reasonably likely to 
contact the soil.  On this particular issue, and as discussed in sections II.E.4 and V.B of this 
document, we are working with USDA and other st akeholders to conduct re search on application 
intervals necessary to ensure the safety of c overed produce when raw manure is applied to a 
growing area and covered produce is reasonably likely  to contact the soil.  We also note that we 
considered several regulations , recommendations, and guidelines that address soil amendments, 
including those from State, fede ral, and internationa l agencies, industry, and trade associations 
(including the California code of regulations fo r composting yards).  In  addition, we consulted 
with experts from multiple organizations and aca demia for scientific and technical input on the 263 
 
issues addressed in these provisions.  The provi sions proposed take into account information and 
input gathered through these consultations. c. Treatments, processes, and practices One comment suggested that many growers ar e accepting food waste compost, which has no 
manure in it but can often have a r eadily detectable level of Salmonella
, and stated that “green 
waste” (or similar) does not necessarily equate to zero risk.  Comments stat ed that if raw manure 
is used, there should be a scien ce- and risk-based standard for determining the application-to-
harvest waiting interval and that maximizi ng the time interval between soil amendment 
application and harvest is only lo gical if using fresh manure.  Si milarly, one comment stated that 
raw manure can be applied to soil if it is plowed  and then given sufficient time before planting.  
Our review of various composting methods suggests that, regardless  of the source, if the process 
is properly conducted (including pr oper turning of feedstock) th e expected pathogen load and 
subsequent likelihood of produce contamination can be minimized.  We agree that certain 
sources, including plant material (Ref. 165) and animal sources (Ref. 166), have differing 
likelihood of containing human pat hogens or higher population leve ls of human pathogens.  To 
address this concern, we propose separate, but related, provisi ons. First, we do not propose 
treatment or timing restrictions for biological soil amendments that do not contain any animal 
waste product or human waste (such as would be  the case with yard wa ste, purely vegetative 
matter, or shrub trimmings, or agricultural teas made from such material s).  Such biological soil 
amendments would not be subject to the requireme nts in proposed subpart F because they would 
not fit the definition of “biological soil amendmen ts of animal origin” and they do not contain 
human waste.  Further, in § 112.51(b)(4) we prop ose that a biological soil amendment of animal 
origin contains a component that is untreated wa ste that you know or have reason to believe is 264 
 
contaminated with a hazard or has been associat ed with foodborne illness, you must regard it as 
if it were an untreated biological soil amendment of animal origin for application and treatment 
purposes if you still wish to utiliz e it.  In addition, we treat “table waste” as “animal waste” for 
the purposes of the definition of biological soil amendments of anim al origin.  As discussed in 
the QAR, post-consumer waste, or  table waste (such as plate sc rapings), has a greater likelihood 
of being contaminated, or contaminated at high er populations, with human  pathogens due to its 
unknown content (e.g., animal products, vegetable pr oducts, etc.) and its gr eater likelihood of 
containing human fluids or wast e (e.g., spittle, vomitus, etc) (Ref. 167). 
Proposed § 112.56(a)(1)(i) would requi re that if you apply a biologi cal soil amendment of animal 
origin that is untreated (suc h as raw manure), where covered produce is reasonably likely to 
contact the soil after application, the material must be applied in  a manner that does not contact 
covered produce during application and minimizes the potential for contact with covered produce 
after application and the minimum application interval is nine (9 ) months. In section V.F.2.f. of 
this document we discuss the reasons for this proposed requirement in detail.  Proposed § 
112.56(b) would allow you to establish and use an a lternative application in terval under certain 
conditions (discussed further in section V.B. of th is document).  In situations where the covered 
produce will not contact the soil after applicati on, proposed § 112.56(a)(1)(ii ) would require that 
the biological soil amendment of animal origin be applied in a manner that does not contact the 
produce at or after application, bu t would not require an applicati on interval.  Also, as discussed 
in section II.E.4. of this document, FDA is co llaborating with partners on research that may 
provide scientific support for sp ecific alternatives to this pr oposed application interval.   
One comment stated that compost made with an imal manure must meet temperature, mixing, and 
time requirements to ensure its safety, whereas an other comment stated th at biologically active 265 
 
soil suppresses pathogens and that E. coli  pathogens decline more rapidly in soils with a large 
diversity of microorganisms rather than in st erile soils.  One comment recommended that we 
require compost operations to have standard op erating procedures, a qua lity assurance plan, 
compost testing within specified timeframes of  sale, and a Hazard Analysis Critical Control 
Point (HACCP) program.  According to this co mmenter, several growers are requesting testing 
prior to purchase, and are refusing compos t that has not been recently tested.  
Based on our review of the litera ture and as discussed in our QAR , we determined that improper 
composting will not have the desired pathogen reduc tion effect, and may enhance the survival of 
pathogenic organisms (Ref. 168).  Therefore, we propose specific  time and temperature controls 
for composting procedures in proposed § 112.54( c), and further recognize the need for 
composters to consider other factors that will im pact the successful treatm ent of their particular 
composting situation (e.g., feedstoc k, C:N ratios, pH).  We consid er that the potential effects of 
soil ecological diversity on pat hogen populations are regionally specific, and may be highly 
effective under some circumstances, while poten tially inert under othe r circumstances.  We 
recognize the need for consistent treatment by supp liers of treated biologi cal soil amendments of 
animal origin, and for assurance by those that us e such amendments that the material has been 
produced under adequate conditions , to avoid it being a source of contamination.  We have 
tentatively concluded that the most reliable a nd least burdensome proposal regarding the use of 
purchased treated biological soil amendments of animal origin is to require growers to obtain 
certain documentation (such as a Certificate of Conformance) from the treating operation that 
validated treatment methods were utilized, the tr eatment process is periodically verified through 
testing, and good handling practices  were followed. This is proposed in subpart 112.60(b)(2) and 266 
 
we request comment on this pr oposed requirement, including pe riodic verification through 
testing.  d. Testing for pathogens Several comments suggested that variable mini mum application-to-harvest waiting intervals 
should be applied using science-based knowledge about pathogen levels in and transfer from 
compost, and that if a compost tests pathoge n-free, there should be no time limit between 
application, planting, and harvest.  Another comment  stated that pathogen  testing has significant 
limitations, and that it would be more important to evaluate a treatment process to ensure that it 
is effective in inactivating pathogens. We considered testing of individual lots of bi ological soil amendments of animal origin as a 
means to determine if they were suitable for application to a fresh produce growing area and 
tentatively conclude that such testing is not a reliable means of determining the safety or 
expected likelihood of contamina ting produce by use of biological  soil amendments of animal 
origin.  We have multiple concerns that led us to this conclusion.  First, we were unable to 
determine standardized testing methods, such as  sample collection methods, sample collection 
times, or location of sample collection, which w ould yield repeatable and reliable results under 
different circumstances.  Second, we were unable to determine the frequency and sample size 
that would reliably indicate th e microbiological safety of a given manure lot.  Third, we 
recognize that there are nume rous pathogens which may be present in biological soil 
amendments of animal origin and that pathogen te sting would be necessary for all such potential 
contaminants, which would be a significant ec onomic burden.  Therefore, we tentatively 
conclude that an approach that is the most reasonable and the mo st protective of public health 267 
 
would involve the use of treatments that have b een validated to meet cer tain specified microbial 
standards as proposed in this subpart.  e. Research needs Some comments suggested that ther e is a need for research to id entify means other than through 
heat to inactivate pathogens, and that such al ternative approaches may be more practical for 
farmers.  Comments opined on the use of chemical  inactivation, and noted that the effectiveness 
of use of volatile acids or ammonia in the inactiv ation of pathogens is not fully established but 
that further research may help refine time and te mperature parameters for chemical inactivation.   
We agree that further research  and innovation may lead to alte rnatives to heat treatments. 
Proposed § 112.54 addresses the use of  physical processes, chemical processes, or combinations 
of physical and chemical processes, in addition to  composting, that may be used as treatments for 
biological soil amendments of anim al origin, provided that they m eet the applicable requirements 
of § 112.55 and the treated biological  soil amendment of animal orig in is applied in accordance 
with the applicable requirement s in § 112.56.  We consider heat  treatments to be physical 
processes within the meaning of  that term in § 112.54, and we have purposefully chosen the 
broader term “physical processes”  to allow for possibilities other than heat treatment.  Thus, 
these proposed requirements would allow for the use of alternatives to heat treatment, and are 
intended to be flexible to fost er innovation and development of new means of treating biological 
soil amendments of animal origin to ensure produce safety.  2. Proposed Requirements As proposed in § 112.3, “soil amendment” would be defined to mean any chemical, biological, or physical material (such as elemental fertil izers, humus, manure, non-fecal animal byproducts, 
peat moss, perlite, pre-consumer vegetative wa ste, sewage sludge bi osolids, table waste, 268 
 
agricultural tea and yard trimmings) intentionally added to the soil to improve the chemical or 
physical condition of soil in relation to plant growth  or to improve the capacity of the soil to hold 
water.  Additionally, “biological soil amendment”  would be defined in § 112.3 to mean any soil 
amendment containing biological materials such as humus, manure, non-fecal animal 
byproducts, peat moss, pre-consumer vegetative wa ste, sewage sludge biosolids, table waste, 
agricultural tea, or yard trimmings, alone or in combination.  Finally, proposed § 112.3 would 
define “biological soil amendment of animal orig in” 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 combina tion, and would specify that the term does not 
include any form of human waste.   See section V.A.2.b.iii. of this document.  Proposed subpart F 
is focused on biological soil amendments of an imal origin, which include animal manures and 
other materials of animal origin that you inte ntionally add to a grow ing area, and on human 
waste.  Standards directed to animal feces de posited by domestic or wild animals that are not a 
part of your planned growing activities (e.g., by working animals, by animals that graze or 
encroach into your growing areas) are proposed to  be included in subpart I, as discussed in 
section V.I. of this document. As discussed in the QAR, animal waste is likely to contain bacterial pathogens (e.g., 
Campylobacter,
 Salmonella  spp., enterohemorrhagic E. coli ) and various other pathogens such as 
parasites (e.g., Cryptosporidium parvum, helminthes ), which may infect humans.  The type of 
pathogen that may be present, and the extent to  which it may be present, is dependent on the 
source of the manure (e.g., E. coli  is more common from rumina nts such as cattle, whereas 
Salmonella is more common from fowl such as chickens ) and the rearing prac tices of the source 
animals (e.g., animals from densely populated  farms or farms with a high population of 269 
 
immature animals have an increased li kelihood of harboring various pathogens) (Ref. 169).  
Enteric (or gastroinstestinal) pat hogens are not generally considered  to be environmental, and are 
more commonly expected to be derived (and in  higher populations) from a human or animal 
source (e.g, through feces, mortalities, blood, spittle, etc.) (Ref. 170).  Material that does not 
contain any animal waste is far less likely to harbor these food  safety hazards at microbial 
populations that can reasonably be expected to lead to severe a dverse health consequences or 
death (Ref. 94).  We have tentatively concluded that  the likelihood of contaminating produce by 
use of biological soil amendments that do not contain animal waste or  human waste (e.g., yard 
trimmings, pre-consumer vegetativ e waste) carrying human pathogens  is low.  Similarly, we are 
unaware of a situation in which chemical and physical soil amendments, such as elemental 
fertilizers (e.g., potash, aqueous nitrates), soil st abilizers (e.g., sand or crushed rock) or others 
typically made of mined or synthetic materi als, have served as sources of microbial 
contamination and, therefore, neither chemical  nor physical soil amendments are a focus of 
provisions of this rule.  Therefore, in this proposed subpart F, we are proposing to focus on 
biological soil amendments of animal origin and human waste, which present a reasonable 
likelihood of harboring human ente ric pathogens. Unless otherwise specifically noted, chemical 
soil amendments, physical soil amendments, and biological soil amendments that are not of 
animal origin (other than those that contai n human waste, which are covered by proposed § 
112.53) are not covered by this rule .  We encourage comment on our tentative decision not to 
provide requirements for the use of these kinds  of soil amendments in this proposed rule.  
a. Requirements for determining status  Proposed § 112.51 would establish re quirements for determining the status of a biological soil 
amendment of animal origin for use in c overed activities.  Proposed § 112.51(a) would 270 
 
categorize a biological soil amendmen t of animal origin as treated  if it has been processed to 
completion to adequately reduce microorganisms of public health significance in accordance 
with the requirements of §112.54, or in the case of  an agricultural tea, the biological materials 
used to make the tea have been so processed a nd the water used to make the tea satisfies the 
requirements of 112.44(a).  Section 112.51(b) woul d categorize a biological  soil amendment of 
animal origin as untreated if: (1) it has not been processed to completion in accordance with the 
requirements of § 112.54, or in the case of an agri cultural tea, the biologi cal materials used to 
make the tea have not been so processed or the water used to make the tea does not satisfy the 
requirements of 112.44(a); (2) it has become cont aminated after treatment; (3) it has been 
recombined with an untreated biol ogical soil amendment of animal origin; (4) it is or contains a 
component that is untreated waste that you know or  have reason to believe is contaminated with 
a hazard or has been associated with foodborne illness; or (5) it is an agricultural tea that 
contains an agricultural tea additive. 
Proposed § 112.51(a) would provide a simple method of referring to biolog ical soil amendments 
of animal origin as treated if they have rece ived one of the treatment processes described in 
proposed § 112.54.  We discuss those treatment pro cess options in detail in section V.F.2.d of 
this document.  Agricultural teas are mentioned se parately for two reasons.  First, treatments are 
typically applied to the bi ological materials used to make agricult ural teas rather than to the teas 
themselves and our explicit mention of this fact is intended to aid in clarity.  Second, we specify 
that the water used to make a treated agricultural t ea must meet the standard in proposed § 
112.44(a) to prevent the introductio n of pathogens into treated ag ricultural teas, which can be 
applied with fewer application re strictions than untreated agricu ltural teas in accordance with 
proposed § 112.56.  As discussed in section V. E.2.d of this document, the conditions under 271 
 
which agricultural tea is produced (moist a nd nutrient-rich) support the multiplication of 
pathogens, if present (Ref. 142).  Even a low number of pathogens introduced into or onto 
covered produce through contaminat ed water could rapidly increase to levels that could present 
risk of serious adverse health consequences or  death to those who c onsume the covered produce 
for which the tea was used (Ref. 142).   
Proposed § 112.51(b) addresses the situations in which a biologi cal soil amendment of animal 
origin should be regarded as untreated because they present a greater likelihood of contamination 
to covered produce than a treated biological so il amendment of animal origin.  A treated 
biological soil amendment of animal  origin can be expected to ha ve a high content of available 
nutrients and minerals which can support rapid and prolific microbial population growth if 
sufficient moisture is available, possibly with limited competitive native microflora (Ref. 171) 
(depending on the specific treatment, treatment pa rameters, and handling used, (e.g., heat treated 
poultry manure pellets would be expected to have limited microorganism content including 
competitive native microflora, and composted manur e would be expected to have substantial 
competitive native microflora)) (Ref. 171.Ref. 172).  Accordingly, pathogens could grow 
prolifically in a treated biologi cal soil amendment of animal origin if it were to become 
contaminated through contact or partial mixing w ith an untreated biolog ical soil amendment of 
animal origin, or other potential contaminant s ource, and if sufficient moisture were available 
(Ref. 171).  Prolific microbial grow th could also occur through  premature termination of 
treatment, which could leave su rviving microorganisms and a highe r moisture content than after 
composting is completed.  In addition, if a biol ogical soil amendment of animal origin contains a 
component that is untreated waste that you know or  have reason to believe is contaminated with 
a hazard or has been associated with foodborne illne ss, we tentatively conclude that the increased 272 
 
likelihood of pathogen presence in such materials results in a need to apply the most stringent 
controls to their use in the grow ing of covered produce.  Prolific  growth of a human pathogen in 
a nutrient-rich, possibly competiti on poor, biological soil amendment of animal origin could lead 
to the amendment acting as an inoculum that spreads microorganisms on any field or covered produce growing area to which the amendment may be applied, leading to  a potential significant 
likelihood of produce contamination.  To avoid su ch inoculation, we propose to require you to 
regard any biological soil amendment of animal orig in that is partially or incompletely treated as 
an untreated biological soil amendment of animal origin.  Finally, we tent atively conclude that 
agricultural teas that contain agricultural tea addi tives should be regarded  as untreated biological 
soil amendments in light of thei r content and the like lihood that they contain human pathogens.  
As discussed in section V.F.2.f. of this document, we tentativel y conclude that the treatment 
process (including composting proc esses) can reduce the populations of pathogens significantly.  
However, it has been recently reported that while pathogens that are presen t in agricu ltural teas 
made from properly composted humus are reduced to undetectable levels within 8.5 days, such 
agricultural teas with added nutrient supplements  (i.e., agricultural tea additives) allow low 
populations of remaining E. coli
 O157:H7, Salmonella , and fecal coliforms to grow and multiply 
(Ref. 142).  For this reason, we propose to impose the same applicati on restrictions on 
agricultural teas that have been prepared with nu trient additives as those that we propose for the 
use of untreated biological soil amendments of animal origin, such as raw manure (proposed § 
112.56(a)(1)(i)), and seek comment on this propos al. See section V.F.2.f. of this document for 
further discussion of the reasons  for these restrictions.   
b. Requirements for handling, conveying, and storing  273 
 
 Proposed § 112.52 would establish requirement s for handling, conveying and storing soil 
amendments of animal origin.  Specificall y, we propose in § 112.52(a) that you handle, convey, 
and store any biological soil ame ndment of animal origin in a manner and location such that it 
does not become a potential source of contamina tion to covered produce, food-contact surfaces, 
areas used for a covered activity, water sources, and water distribution systems.  As discussed 
immediately above, prolific growth of a hu man pathogen in a potentially competition-poor, 
nutrient-rich, biological soil amendm ent of animal origin could l ead to the amendment acting as 
an inoculum that spreads microorganisms on any field or covered produce growing area to which 
the amendment may be applied, as well as to food-contact surfaces, areas used for covered 
activities, water sources, and water distribution sy stems.  To fulfill the proposed requirement in § 
112.52(a), we would expect you to take specific meas ures to ensure that untreated biological soil 
amendments of animal origin do not contaminate covered produce directly or indirectly through 
contact with food contact surf aces, areas in which covered activities are conducted, water 
sources, or distribution systems.  Such measures may include, for example, separation of treated 
and untreated manure (or other bi ological soil amendments of an imal origin) and preventing any 
leachate originating from untreat ed biological soil amendments of  animal origin from becoming 
a source of contamination for source water or water distribution systems (Ref. 173).     
As discussed in the QAR, any untreated biologi cal soil amendment of animal origin that 
contaminates a food contact surface could be a s ource of further cross-contamination to covered 
produce. Moreover, a biological soil amendment of  animal origin that has been treated by a 
composting process may still have  a residual population of pathogens, since composting is not a 
complete kill step (Ref. 174); therefore, such biological so il amendments require a multiple 
hurdle approach to minimize the likelihood of introducing pathogens to a field on which they are 274 
 
applied.  If composted material contaminates a food contact surface, the combined presence of 
available nutrients plus any pathogens that may have survived the com posting process present a 
potential source of contamination for any cove red produce that comes in contact with the 
contaminated food contact surface. Further, a fu lly heat-treated biologi cal soil amendment of 
animal origin, while reasonably likely to be fr ee of pathogens, may act as a source of nutrients 
for pathogens that might contaminate the food c ontact surface, thereby al lowing them to multiply 
and pose a likelihood of contaminating any prod uce coming in contact with the food contact 
surface.   
As proposed, § 112.52(b) requires th at you handle, convey and store any treated biological soil 
amendment of animal origin in a manner a nd location that minimizes the likelihood of it 
becoming contaminated by an untreated or in-p rocess biological soil amendment of animal 
origin. This proposed requirement is necessary because a biological soil amendment of animal 
origin previously treated to reduce pathogens can become re-contaminated by pathogens if not 
properly handled and stored (Ref. 175).  For example, if you fully compost manure produced by 
your cows with the intent of using it to amend a field you use to grow covered produce, proposed 
§ 112.52(b) would require that you handle, convey, and store the fully composted manure in a 
manner and location to prevent its contamin ation by raw manure, or by manure in the 
composting process.  This requirement is critical  because bacterial pathog ens, such as E. coli  
O157:H7 or Salmonella  spp., if allowed to re-contaminate finished compost, may grow and 
spread to populations that pr esent a significant likelihood of c ontaminating any environment in 
which the soil amendment is used (Ref. 171).  An example of cross- contamination may include 
turning a pile of manure that is  in the process of composting w ith a front-end loader, and then 
proceeding to handle fully composted humus from a mature pile with the same equipment.  To 275 
 
avoid such cross-contamination, you could clean the front-end loader between manipulating an 
incomplete pile and manipulating a mature pile ; move “downstream,” beginning with sanitary 
equipment and manipulating the most mature piles fi rst, then proceeding to less mature piles; or 
designate certain equipment to only be used on piles of a certain maturity; or adopt other 
strategies that meet the same goals.   Proposed § 112.52(c) would require you to handl e, convey, and store any biological soil 
amendment of animal origin that has become cont aminated (for example, by an untreated or in-
process biological soil amendment of animal origin ) as if it was untreated.  In other words, a 
treated biological soil amendment of animal origin that has beco me contaminated would need to 
be applied in accordance with the application a nd interval restrictions of proposed § 112.56(a)(1) 
for untreated biological soil amendments of animal  origin, or it would need to be treated in 
compliance with one of the options in proposed  § 112.54 and then applied in accordance with the 
applicable requirements in § 112.56 for the treatment  used.  For example, if a treated or in-
process biological soil amendment of animal or igin becomes unintentionally contaminated (e.g., 
from runoff from an untreated biological soil amendment of an imal origin), you would either 
need to treat that material in accordance with an option in proposed § 112.54 and then apply it in 
accordance with the applicable requirements in § 112.56 for the treatment used, or you would have to follow the application re quirements for untreated biologi cal soil amendments of animal 
origin in proposed § 112.56(a)(1) fo r the contaminated material.   
c. Prohibition regardi ng use of human waste 
Proposed § 112.53 would prohibit the use of hum an waste for growing covered produce, 
except sewage sludge biosolids used in accord ance with the requirements of 40 CFR Part 503, 
subpart D, or equivalent re gulatory requirements.  Human waste has a high probability of 276 
 
containing multiple diverse human pathogens, in cluding bacteria, parasites and viruses, at 
potentially very large populati ons, thus presenting a significant  likelihood of harboring and 
spreading these various microbiological hazards (Ref. 92).  We recognize that  an application of 
untreated human waste could occur outside of your control (for example, as a run-off event from 
adjacent land not under your control), or may have occurred as a previous use of land before you 
took possession.  If you know or have reason to be lieve such an event has occurred, we would 
expect you to take measures reasonably necessary to minimize the risk of serious adverse health 
consequences or death based on your specific circumstances.  Su ch measures may include crop 
diversion, reconditioning or dest ruction, and/or land remediation, or other comparable methods. 
Under 40 CFR part 503 subpart D (§ 503.30, 31, 32 and 33), the U.S. EPA requires that 
the application of sewage sludge biosolids to fiel ds in which food or feed  crops are grown adhere 
to certain pathogen reduction re quirements, and use certain vect or attraction reduction options. 
Depending on which options are implemented, there are different ranges of  wait periods between 
application of the soil amendment, and the harv est of the crop grown.  For example, if an 
untreated human waste (i.e., equiva lent to domestic septage: “li quid or solid material removed 
from a septic tank, cesspool, portable toilet”) (40 CFR § 503.9(f)), is applied to a field used to 
produce a food crop, then “Food crops with harveste d parts that touch th e sewage sludge/soil 
mixture and are totally above the land surface shall not be harvested for 14 months after 
application of sewage sludge” (40 CFR § 503.32(c)(1 ), cross-referencing § (b)(5) of the same 
section).  We agree these standa rds are appropriate for protecting public health and, therefore, we 
are not proposing to implement further restrictions .  Our proposed definition of agricultural teas, 
discussed in section V.A.2.b.iii. of this document,  would provide that agricultural teas are not 277 
 
made from any form of human waste because doing so would not be permissible under 40 CFR 
part 503 subpart B. 
d. Acceptable treatment processes  Although there is great variability in available data on pathogen survival in animal 
manure depending on the type and source of manur e in question, the loca tion and environment 
under which the manure is store d, and numerous other factors 
(Ref. 176.Ref. 177.Ref. 178) there 
are data to suggest it is reas onable to expect that, given th e proper conditions, pathogens in 
certain animal manures may survive for months (Ref. 179), years (Ref. 180), or even indefinitely 
(Ref. 174).  Because the use of soil amendments that contain materials of animal origin poses a 
significant likelihood of contaminating the gr owing environment and covered produce with 
human pathogens, we have tentatively concluded th at such materials used as a soil amendment 
require some level of treatment, or other risk-red ucing steps (such as appli cation restrictions), for 
use in the growing of covered produce.  Pr oposed § 112.54(a)-(c) would establish acceptable 
treatment processes for a biological soil amendm ent of animal origin when applied in the 
growing of covered produce, along with associated  microbial standards against which they must 
be validated in proposed § 112.55.  A validated  process, when properly implemented and 
monitored, would be expected to meet the lis ted microbial standards and thereby reduce the 
likelihood of hazards associated with biological  soil amendments of animal origin from 
contaminating covered produce.  The microbial standards in proposed § 112.55 are not meant as 
lot-by-lot microbial testing requirements. In stead, the person applying the treatment process 
would need to monitor the physical parameters of the process (e.g., temperature of a compost 
pile) to ensure that they meet the conditions un der which the process was validated.  In addition, 
proposed § 112.54 would provide that  the resulting biologi cal soil amendments must be applied 278 
 
in accordance with the appli cable application requirements in § 112.56. We seek comments on 
this approach.  The underlying framework for the provisions of §§ 112.54(a)–(c), 112.55, and 112.56 is that as 
the likelihood that a method of application of a biological soil amendment of animal origin will 
result in it contacting covered produce increases, the extent of measures taken to reduce the 
likelihood of known or reasonably foreseeable microbi al hazards being present in the applied soil 
amendment must also increase.  That is, for an app lication practice that is more likely to result in 
the amendment contacting covered produce (e.g., br oadcast application of  a soil amendment vs. 
subsurface soil amendment injection for the same crop, or in-row application of a soil 
amendment for a row crop vs. in-row application fo r a tree crop), it is more important to have 
stricter controls for known or reasonably fore seeable microbial hazards in the applied soil 
amendment than for another amendm ent whose application practice is  less likely to result in the 
amendment coming into contact with covered pro duce.  Therefore, proposed § 112.54 consists of 
multiple acceptable options for the treatment of  soil amendments and corresponding standards 
against which they are to be  validated (as further descri bed in § 112.55).  These proposed 
treatment options were designed to be flexible to allow you to determine what your operation’s 
needs are, and select the option that best f its those needs. In developing these proposed 
requirements, we have taken into account the wi de variation presented by  different feedstocks 
used in preparing biological so il amendments of animal origin, the diversity of commodities, and 
various growing regions.  In addition, we cons idered the like lihood of contamination posed by 
biological soil amendments of animal origin su bjected to each of these multiple treatment 
options when determining the appropriate appl ication requirements, as proposed in § 112.56.  
We have tentatively concluded that the use of the physical, chemical, and composting treatments 279 
 
listed in proposed § 112.54(a)-(c), when applied in accordance with proposed § 112.56, are 
capable of adequately reducing pathogen levels in  biological soil amendments of animal origin.  
We request comment on the appropriateness of each  of the options considered, and discussion of 
any other options not listed in proposed § 112.54. 
Physical treatments usually involve some fo rm of high-heat treatme nt (cooking) of the 
biological soil amendment of animal origin to kill undesirable microorganisms.  By contrast, 
chemical treatments usually involve greatly alte ring the pH of a biolog ical soil amendment of 
animal origin, to the point that undesirable micr oorganisms do not survive.  In a study treating 
chicken manure with ammonia to reach high (alkalin e) pH levels, a 3 to 4 log decrease of generic 
E. coli  was observed over 6 days at 20ºC, and drying manure to  10% moisture content and 
exposing it to ammonia gas (1% of manure wet weight) reduced pathogen load by 8 log 
(99.999999% reduction) (Ref. 181).  To perform either physical or chemical treatments, the 
feedstock is generally placed in  a large treatment container, and large amounts of energy are 
required in order to initiate the treatment. Th ese factors alone make these forms of treatment 
impracticable for many farms. While such treatmen ts can be expected to have a strong lethal 
impact on microorganisms present in the feedst ock, they do not always result in complete 
elimination of pathogens. For example, chicken manure may be heat-treated to create a dried, 
pelleted material that is functionally sterile  due to the high heat used during production; 
however, it has been observed that if the heat treatment is not uniform, the end product may still 
harbor human pathogens and pose a likelihood of the material being re-colonized by the 
microbial pathogen, leading to th e possible contamination of any covered produce to which it is 
applied (Ref. 115). 280 
 
Biological soil amendments of animal origin may also be prepared by combining multiple 
treatments, either alone or in combination. For ex ample, a single feedstoc k may be heat-treated 
(physical) while also drenched in strong a mmonia (chemical) to acidify the material (Ref. 182). 
Alternatively, feedstock may firs t be composted and then treated by heat to further reduce 
pathogens, effectively pasteurizi ng the material, as is common practice in the production of 
mushroom growth media (Ref. 183). These systems have been shown to be highly effective when 
proper controls are in place and monitored, but they  also require significant inputs and capital 
investments. Proposed § 112.54(a) would establish that a scientif ically 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 demons trated to satisfy the microbial 
standard in § 112.55(a) fo r Listeria monocytogenes
, Salmonella  spp., and E. coli  O157:H7 is a 
treatment option for biological soil amendments of animal origin. Th is standard is currently used 
by the mushroom industry, which utilizes a tw o-phase process consisting of a composting 
treatment that meets the composting standard pr oposed in § 112.54(c) followed by a subsequent 
heating process that meets the microbial st andard of proposed § 112.55(a).  Together, the 
treatment reduces over 7 log cfu/g of Listeria , Salmonella , and E. coli  O157:H7 to undetectable 
levels (Ref. 183).  It also eliminates much of the native microflora (Ref. 183).  We have 
tentatively concluded that a treatment meeting this standard would si gnificantly reduce or 
eliminate known or reasonably foreseeable microbial  hazards in biological soil amendments of 
animal origin, and would constitute the lowe st expected likelihood of  any of the proposed 
treatment options.  We have also tentatively concluded that a biologi cal soil amendment of 
animal origin that has been treated to this standard would be appropriate for use when the 281 
 
likelihood for contamination of covered produce is  the highest, such as the substrate (growth 
media) used for growing mushrooms and some spr outs.  Therefore, as provided in proposed § 
112.56(a)(2) and discussed further in section V.F.2.f of this document, any biological soil 
amendment of animal origin treated to this st andard would have the fewest limitations on its 
application. Proposed § 112.54(b) would establish that a scientifically valid controlled physical process, 
chemical process, or combination of scientif ically valid controlled physical and chemical 
processes, that has been demonstrated to sa tisfy the microbial sta ndard in § 112.55(b) for 
Salmonella
 and fecal coliforms is a treatment option for biological soil amendments of animal 
origin.  We have tentatively concluded that a tr eatment meeting this stan dard would significantly 
reduce known or reasonably foreseeable microbia l hazards in biological  soil amendments of 
animal origin leading to minimal likelihood of co ntamination.  A biological soil amendment of 
animal origin that has been treated to this sta ndard would be appropriate for use when there is a 
high likelihood that the soil amendment will come into contact with covered produce.  Moreover, 
as provided in proposed § 112.56 and discussed further in section V.F.2.f of this document, any 
biological soil amendment of animal origin tr eated to this standard would have minimal 
limitations on its application. 
Proposed § 112.54(c) would establish that a sc ientifically valid c ontrolled composting 
process that has been demonstrated to satis fy the microbial standard in § 112.55(b) for 
Salmonella  and fecal coliforms is a treatment option fo r biological soil amendments of animal 
origin. Two specific scientifically  valid controlled composting pro cesses that could be used to 
meet the requirements of proposed § 112.54(c) are provided: 1) static co mposting that maintains 
aerobic (i.e., oxygenated) conditions  at a minimum of 131°F (55 °C) for 3 days and is followed 282 
 
by adequate curing, which include s proper insulation; and 2) turned composting to maintain 
aerobic conditions at a minimum of 131°F (55 °C) fo r 15 days, with a minimum of five turnings, 
and is followed by adequate curing, which incl udes proper insulation.  These two composting 
processes are currently c onsidered by the U.S. Environmental Protection Agency as Processes to 
Further Reduce Pathogens (Appendix B to 40 CFR 503, part B.1).  Both are recommended for use by the U.S. Department of Agricultu re’s Agricultural Research Service 
(Ref. 184), Natural 
Resources Conservation Service (Ref. 97), and National Organic Program (7 CFR 205), and both 
are commonly accepted practices within the industry (Ref. 185). While there is robust discussion 
in the literature on times, temperatures, and ot her conditions (pH, moisture, oxygen levels, etc.) 
needed for significant reductions (a lbeit not elimination) of human pathogens in cattle, sheep and 
chicken manures, it is clear that composting canno t be considered as a pa thogen-elimination step 
because of the many variables that can affect  the efficacy of the composting process (e.g., 
feedstock mixtures, climatic conditions, a nd various other physio-chemical parameters) (Ref. 
174).  These limits are currently used as compos ting endpoints by other federal agencies (40 CFR 
503) States (Ref. 90.Ref. 164.Ref. 163), and industry (Ref. 31). 
Composting is generally the least expensive method with the lowest capital investment 
requirement, and if properly managed, can be expected to signifi cantly reduce pathogen 
populations in feedstock materials (Ref. 186). As noted in the Produce Sa fety Project Issue Brief 
on Composting of Animal Manures, composti ng has been shown to reduce the overall 
concentration of nitrogen in the soil amendment, which poses a concern for some farmers, but it 
also has been demonstrated that the remaining nitr ogen is both in a more bio-available state (i.e., 
more easily utilized by plants) and will persist in  the environment for a longer time (therefore 
providing nutrients to plants for a longer time) (Ref. 27). Composting leaves much of the native 283 
 
microflora intact (Ref. 187).  Proper composting is not difficult for most operations, but it does 
require a labor commitment to ensure conditions are met and maintained to achieve the desired 
effect. Some of the most critic al elements of composting include  proper stacking of a pile, proper 
aeration and turning, and ensuring th e pile attains the proper temper ature and is allowed to cool 
(cure) for an adequate time (Ref. 27).  There are currently no federally mandated composting 
standards for food safety. The USDA/NOP offers  standards that are meant to maximize soil 
fertility in 7 CFR § 205.203 (these are required to achieve “USDA Certified Organic” status, but 
otherwise are recommendations on ly), and EPA standards in 40 CFR Part 503 are specific to 
sewage sludge, not animal manures. While these standards were not developed for food safety, 
several studies suggest that th ey would be appropriate for use as food safety measures (Ref. 27). 
Proper handling and storage during and after composting to avoid cross-contamination of cured 
product and in-process or raw product is critical, as discussed in section V.F.2.b of this document 
above regarding proposed § 112.52 of this rule. Other important factors in proper composting 
(such as the carbon to nitrogen ratio  of the feedstock (C:N), the mo isture content of the pile, the 
reaction to high cellulose-content material (i.e., plan t material such as stra w or vegetative waste), 
and the specifics of the beneficial microbial  content will vary depending on the feedstock (Ref. 
187).  The person who manages the composting process would also need to consider such factors 
as the moisture content, pH, carbon to nitrogen  ratio (C:N), and feed stock to achieve the 
microbial standards set forth in proposed § 112.55. Many resources are available that discuss 
these details, such as the USDA NRCS handbook (Ref. 97).  When composting processes are 
carried out in an incorrect manner, the organi c matter in the finished product remains poorly 
stabilized and recontamination is  more likely to occur, whic h can potentially result in the 284 
 
compost becoming a source of pathogens that coul d contaminate the field to which it is applied 
and any crops that are grown in the amended soil (Ref. 165).   
As noted in the Produce Safety Project Issue Brief on Composting of Animal Manures, adequate 
curing, including proper insulation (usually cons isting of around one foot thick of insulating 
material, e.g., hay, straw, finished compost) is included as part of this proposed requirement, 
because curing is an important step in the comp osting process to further reduce the levels of 
pathogens, complete the chemical reactions of composting, and mitig ate the impact that 
incomplete turning (creating temperature stratif ication within an active pile) would have on 
composting efficacy (Ref. 27).  Proper insulation serves as a layer of protection from external 
influences (e.g., temperature changes,  wild animal encroachment).   
The treatment processes proposed in § 112.54(c), pa ragraphs (1) and (2), may not be the only 
means of achieving adequate composting to m eet the microbial standards in proposed § 
112.55(b). Therefore, we have tentatively concluded that it would be appropriate to allow for the 
use of static or turned compos ting protocols other than those sp ecified in §§ 112.54(c)(1) and (2), 
if they meet the microbial standards for va lidation for composting in proposed § 112.55(b). 
Proposed § 112.54(c)(3) allows for the use of othe r scientifically valid, controlled composting 
processes, provided you satisfy the requirements of § 112.12, including that  the alternative has 
been demonstrated to satisfy the microbial sta ndard in § 112.55(b).  No such alternatives are 
provided for the treatment requirements of  §§ 112.54(a) and 112.54(b), because those parts do 
not explicitly define the proce sses to be conducted to meet the microbial standards presented; 
therefore, any scientific ally valid controlled physical, chemic al, or combination of physical and 
chemical processes that has been demonstrated to satisfy the releva nt microbial standard in either 
§ 112.55(a), or § 112.55(b) will meet the requirements of those subparts. 285 
 
e. Microbial standards applicable to treatment processes 
Proposed § 112.55 establishes microbial standards a pplicable to the treatment processes in § 
112.54.  Proposed § 112.55(a) would pr ovide microbial standards fo r the treatment process in 
proposed § 112.54(a).  It would re quire: (1) L. monocytogenes  to be not detectable using a 
method that can detect one colony forming unit (C FU) per five gram analytical portion; (2) 
Salmonella  spp. to be less than 3 most probable number  (MPN) per four grams of total solids 
(dry weight basis); and (3) E. coli  O157:H7 to be less than 0.3 MPN per 1 gram analytical 
portion.  As discussed immediat ely above regarding proposed § 112.54(a), these standards are 
the most stringent and meant for applications in  which a biological soil amendment of animal 
origin would otherwise pose th e greatest likelihood of transf erring a known or reasonably 
foreseeable hazard to a covered produce commodit y.  These standards would also be useful if 
you wanted to use a biological soil amendment of  animal origin with  the least amount of 
application restrictions availa ble under proposed § 112.56.  As prev iously noted, these microbial 
standards are currently used by the mushroom in dustry for growth media and reduce over 7 log 
CFU/g of Listeria , Salmonella , and E.  coli O157:H7 to undetectable levels (Ref. 183). 
Proposed §§ 112.55(b) would provide two microbial standards, both of which must be satisfied 
for the treatment processes in proposed §§ 112.54(b)  and (c).  This sec tion would require less 
than 3 MPN Salmonella  spp. per 4 grams of total solids (dry  weight basis), and less than 1,000 
MPN fecal coliforms per gram of total solids (dry  weight basis). These limits are currently used 
as composting validation endpoints by EPA (40 CFR 503), some States (Ref. 90.Ref. 164.Ref. 
163), and industry (Ref. 31). Ohio and California (Ref. 163.Ref. 164), industry (Ref. 31) and other 
nations such as Canada and the United Kingdom (Ref. 27) use both of these criteria, while EPA 
and Florida (Ref. 92.Ref. 90) allow for either criteria to be used. As noted in the Produce Safety 286 
 
Project Issue Brief on Composting of Animal Ma nures, the EPA requirement  of validation with 
either Salmonella spp. or fecal coliforms is based on the observation that reduction in fecal 
coliforms is well correlated to reduction in Salmonella  spp. when biosolids are composted (Ref. 
27).  However, we tentatively conclude that sati sfying both of these criteria is necessary to 
significantly minimize known or reasonably fore seeable hazards when combined with the 
applicable applicati on requirements in proposed § 112.56.  M onitoring the relative levels of 
indicator microbes such as fecal colif orms, which are predominantly E. coli  in manures and 
freshly mixed compost, is advantageous in that th ey are abundant in manure.  In the absence of a 
reliably present pathogen, fecal coliforms are usef ul to validate the efficiency of the thermophilic 
composting process (Ref. 27).  Additionally, E. coli , the primary fecal coliform in manure,  has 
been documented to be a good indicato r of the inactivation of E. coli  O157:H7 (Ref. 168).  
Validating solely with Salmonella  spp. is not sufficiently protectiv e or useful for validating the 
efficiency of a thermophilic composting process, since Salmonella spp. cannot be assumed to be 
present in all composting feedstock ma terials.  On the other hand, Salmonella  spp. is the most 
common microbiological hazard as sociated with fresh produce (Ref. 3).  As such, validating with 
fecal coliforms and Salmonella  spp. not only assures the efficacy of the thermophilic composting 
process but also assure s significant reduction of the pathogen Salmonella spp. when commonly 
used compost feedstocks are used that are likely sources of Salmone lla spp. (e.g., cattle and 
poultry manure) (Ref. 188).  We seek comment on these pr oposed microbial standards and 
potential alternatives.  We do not intend this proposed prov ision to require that farms test  their treated biological soil 
amendments for compliance with the microbial sta ndards.  Rather, we intend this provision to 
provide the standard against whic h treatment processes must be va lidated.  Farms would be able 287 
 
to use treatment processes that are validated to meet the relevant microbial standard in this 
section without needing to test th e end products of their treatments  to confirm that the microbial 
standard was achieved. f. Application requirements and minimum application intervals 
Proposed § 112.56 establishes the ap plication requirements and mi nimum application intervals 
applicable to biological soil amendments of an imal origin.  Proposed § 112.56(a) would establish 
a requirement that, except as provided in s ubparagraph (b), any biol ogical soil amendment of 
animal origin that you use must be applied with the application method requirements and 
minimum application intervals specified in the table presenting pr oposed §§ 112.56(a)(1)-(4). 
The different application method requirements a nd intervals for biological soil amendments of 
animal origin are presented so that you may de termine the amendment, application, and interval 
that is most appropriate for your situation, based on the expect ed likelihood of contaminating 
produce by use of the biological soil amendmen t of animal origin you plan to use.  
In developing the application methods require ments of proposed § 112.56(a)(1)-(4), we first 
considered specifications of each type of biologi cal soil amendment of animal origin, and then 
considered the likelihood that the soil amendmen t will come into contact  with covered produce. 
For example, those biological soil amendments of animal origin treated with a process or 
processes capable of consistently and reliably  reducing or eliminating pathogens as per § 
112.54(a) do not have any applica tion restrictions, and may come  into contact with covered 
produce during harvest and growing (proposed § 112.56(a)(2)), such as in the growing of 
mushrooms and some sprouts.  Conversely, those treatments that are expected to have some 
likelihood of harboring significant numbers of human  pathogens, i.e., those treated in accordance 
with the requirements of §§ 112.54(b) or (c), have proposed limitations on the method of 288 
 
application that minimize the poten tial for the treated biological soil amendment of animal origin 
to contact covered produce during and after application (propose d § 112.56(a)(3), (a )(4)(ii)) and 
also allow for pathogen die-off wh en it is reasonably likely that  covered produce will contact soil 
after application of the soil amendment (proposed § 112.56(a)(4 )(i)). Requirements would 
include the application of untreat ed biological soil amendments of animal origin in situations 
where it is reasonably likely that covered produ ce will contact the soil af ter application of the 
soil amendment (§ 112.56(a)(1)(i)), where the amen dment would be permitted to be applied in a 
manner that minimizes the potential fo r contact with covered produce after  application, but with 
an additional food safety measure that it can be applied only in a manne r that does not contact 
covered produce during  application and using a minimum app lication interval of 9 months.  By 
contrast, in situations where covered produce will not contact th e soil, (§ 112.56(a)(1)(ii)), the 
amendment would be permitted to be applied without  an application interval.  We explain each 
of these proposals in detail below. 
Proposed § 112.56(a)(1)(i) requires that if you apply a biological  soil amendment of animal 
origin that is untreated, then the material mu st be applied in a manner that does not contact 
covered produce during application and minimizes the potential for contact with covered produce 
after application and the minimum application interval is nine (9) months. This provision would 
apply to any situation in which the covered produ ce is reasonably likely to contact the soil after 
application of the soil amendment.  Proposed § 112.56(a)(1)(ii) requires  that if you apply a 
biological soil amendment of animal origin that is untreated, and the material is applied in a 
manner that does not contact covered produce duri ng or after application, there is no minimum 
application interval.  This pr ovision would apply to any situa tion in which the covered produce 
will not contact the soil after application of the soil amendment.  The specific microbial 289 
 
populations of raw manure are ge nerally unknown, but can be expected  to be very high, and are 
likely to include zoonotic microorganisms that pose a food safety hazard (such as Salmonella  
spp. up to 10^7 (Ref. 176) and E. coli  O157:H7 up to 10^6 (Ref. 189)). Based on our QAR, we 
have determined that  raw animal waste (manure,  litter, mortalities, etc.) is likely to contain 
human pathogens and has the highest likelihood of  contaminating covered produce.  Therefore, 
we tentatively conclude that such  material should only be used where, and in a manner, that such 
likelihood is minimized.  As discussed above, the likelihood of produce contamination by an 
agricultural tea that contains agricu ltural tea additives is also high (Ref. 142).  Given the desire to 
both allow for the continued use of raw manure, agricultural teas containing agricultural tea 
additives, and other untreated biological soil amen dments of animal origin; and to minimize the 
risk of known and reasonably foreseeable hazards,  we have tentatively co ncluded that we should 
require that untreated biological soil amendment of  animal origin (including raw manure) applied 
in the growing of covered produce should either first be treated to reduce microbial food safety 
hazards; or if the covered produce is  reasonably likely to contact th e soil after application of the 
soil amendment, the untreated soil amendment shoul d be applied in a manner that keeps it from 
coming into contact with covered produce during application, minimizes the potential for contact 
after application, and allows for the die-off of  pathogens; and if the covered produce will not 
contact the soil after applicati on of the soil amendment, the unt reated soil amendment should be 
applied in a manner that keeps it from coming in to contact with covered produce during and after 
application.  In the case of agri cultural teas containing agricultur al tea additives, we tentatively 
conclude that because additional treatment is not  an option they should be applied in the same 
manner as untreated biological soil amendments of animal origin.  Proposed § 112.56(a)(1)(i) 
would therefore establish such restrictions on th e manner of application fo r these materials when 290 
 
they are reasonably likely to come in contact wi th covered produce after a pplication, as well as a 
minimum application interval (w aiting period) of nine (9) m onths from the application of 
untreated biological soil amendments of animal orig in to the harvest of covered produce.  On the 
other hand, under proposed § 112.56(a)(1 )(ii), untreated biological soil amendments of animal 
origin would be permitted for use with no mi nimum waiting period when the soil amendment is 
applied in a manner that does not contact cove red produce during or af ter application.  We 
investigated the potential for su rvival of many enteric pathoge ns of public health concern (Ref. 
190.Ref. 92) and determined that acro ss various pathogens and th eir potential environments, 
pathogen survival and die-off time in soils ame nded with raw manures are extremely varied. One 
consistency across many trials was an observed ra pid early die off of many pathogens, followed 
by a prolonged survival of the remaining low populations (Ref. 191.Ref. 104.Ref. 192). It is 
unclear in the existing literature at what point the population is low enough to minimize the 
potential for contamination of covered produce; it is reasonable to suggest that once pathogen 
populations fall below detection lim its, their risks are minimized.  
Some of the longest survival times involved or ganisms initially present at very high initial 
populations (e.g., E.  coli O157:H7 in sheep manure (Ref. 177) surviving for 21 months) or 
involved certain pathogens such as encysting parasites (Cryptosporidium  parvum  cysts surviving 
for over a year (Ref. 193) or the eggs of parasitic flatworms (Ascaris  ova surviving for over 15 
years (Ref. 174)). Some enteric pathogens are reported to be more resilient to  deleterious effects 
of the environment than ot hers (most notably, Salmonella  seems better attuned for survival 
outside of a host than does E. coli  O157:H7 (Ref. 194)) and those microorganisms that produce 
spores are especially hardy. Basing all manure application standards on these extreme cases 
would be unnecessary. The majority of survival st udies showed that most enteric pathogens of 291 
 
public health importance, under the most common c onditions, would not survive in the soil past 
1 year (Ref. 190). This includes organisms less commonly associated with fresh produce, such 
Cryptosporidium , Giardia , and Ascaris  (parasitic flat worms) . Organisms most commonly 
associated with fresh produce outbreaks (such as E. coli , Salmonella  and Listeria ) are unlikely to 
survive at detectable population levels in soil past 270 days (Ref. 181.Ref. 182.Ref. 183).  
Therefore, we tentatively c onclude that utilizing a 9-m onth waiting period between the 
application of untreated biological  soil amendment of animal orig in and the harvest of covered 
produce would be protective for th e preponderance of environments in situations where covered 
produce is reasonably likely to co ntact the soil after applicati on of untreated biological soil 
amendments of animal origin. This is not inc onsistent with the 12-month restriction used by 
some segments of the produce industry (Ref. 31).  Where the soil amen dment does not contact 
covered produce either during or after application, we do not belie ve that a minimum application 
interval is reasonably necessary  to prevent the introduction of known or reasonably foreseeable 
hazards into covered produce.  Therefore, pr oposed § 112.56(a)(1)(ii) provides for the option to 
use untreated biological soil amendments of animal origin with no minimum waiting period, 
provided the soil amendment is applied in a manne r that does not contact covered produce during 
or after application. We seek commen t on the proposed waiting period.   
One study, which specifically addressed considerations  of microbial survival  in soil and resulting 
transfer on to produce grown in the soil, sugge sted that, under ideal conditions for survival, 
organisms could survive for greater than 226 days (Ref. 191).  The study was performed in the 
Southeastern U.S. (Georgia) and, therefore, is unli kely to reflect climatic  conditions prevalent in 
other areas of the country, including the potenti al for the ground to freeze during winter.  While 
microbes present on frozen ground can be expected  to be reduced in population more rapidly 292 
 
(Ref. 195), those surviving are likely to persist fo r a longer time period in a state of dormancy 
(Ref. 196).  The dormancy of microorganisms also mean s that they will pose a likelihood of 
contamination for greater periods of time, creat ing a wider window of opp ortunity for covered 
produce to become contaminated.  We request comment on whether and how, as an additional requirement for the application of untreated biol ogical soil amendments of animal origin, the 
time period when the soil is frozen should count  toward the proposed ap plication interval.  
Further, it has been noted that rapid freeze-thaw cycles of weathe r may cause more rapid die-off 
rates of pathogens present in soils 
(Ref. 197).  We request comment on the impact that freeze-
thaw cycles may have on use of biologi cal soil amendments of animal origin.  
Proposed § 112.56(a)(2) would estab lish that the use of a biologi cal soil amendment of animal 
origin treated by a scientifically valid controlled p hysical or chemical process, or combination of 
scientifically valid controlled physical and chemical processes, in accordance with the 
requirements of § 112.54(a) to meet the micr obial standard in § 112.55(a), would have no 
application method restrictions a nd no minimum application interval . At this level of microbial 
reduction, a treated biological so il amendment of animal origin can be expected to present 
negligible likelihood of contaminat ion.  Therefore, we have tentat ively concluded that no further 
action is necessary for the safe use of such a product in conjunction with covered produce.  
For example, unlike other biological soil amendmen ts of animal origin, the nature of a growth 
medium that is a biological soil amendment of  animal origin and is used for growing 
mushrooms, some sprouts and similarly grow n produce, makes contact between the covered 
produce and the growth medium inevitable.  This  precludes the ability to utilize application 
restrictions as a meaningful measure to mini mize the likelihood of pathogen contamination of 
covered produce through a multiple-hurdle approach, that would allow for the use of less robust 293 
 
treatment processes in combination with appl ication manner restricti ons.  Therefore, we 
tentatively conclude that, such growth media must be treated by a scientifically valid controlled 
physical or chemical process, or combination of  scientifically valid controlled physical and 
chemical processes, in accordan ce with the requirements of § 112.54(a) to meet the microbial 
standard in § 112.55(a). As proposed, § 112.56(a)(3) would require that a biological soil amendment of animal origin 
treated by a scientifically valid controlled physical or chemical process, or a combination of 
scientifically valid controlled physical and ch emical processes, in accordance with the 
requirements of 112.54(b) to meet the microbial st andard in § 112.55(b) be used in a manner that 
minimizes the potential for contact with cove red produce during and afte r application, with no 
minimum application interval. We have tentativ ely concluded that trea ting a biological soil 
amendment of animal origin to meet the sta ndards of § 112.54(b) would significantly decrease 
the population of any microorganisms of public h ealth significance that may have previously 
been present. Further, the propos ed application restri ction of minimizing direct contact of the 
amendment with the edible por tion of covered produce would further reduce the likelihood of 
any remaining microorganisms in a treated soil  amendment contaminating covered produce, as 
well as reduce the likelihood that the soil amendment would provide  a nutrient source for any 
microorganisms of public health  significance already present on covered produce. We have 
tentatively concluded that the treatment of th e biological soil amendment of animal origin, 
combined with minimizing its contact with covered produce would adequately reduce the 
likelihood of contamination and subsequent severe  adverse health consequences or death. We 
have also tentatively conclude d that, with the like lihood already minimized, it is unnecessary to 
implement a further burden by proposing a minimu m application interval for soil amendments 294 
 
treated by physical or chemical pr ocesses, or combinations of such  processes, to the standards of 
§ 112.54(b). For example, chicken manure pellets th at have been treated by a controlled high-
temperature process according to a protocol that has been valida ted to meet the standards in 
proposed § 112.54(b) could be used as an in-fu rrow side-dress for leafy greens immediately 
before harvest. However, in this same exam ple, the application could not be conducted by 
overhead broadcast spreading, si nce this method would not mini mize contact of the biological 
soil amendment with the covered produce. Proposed § 112.56(a)(4)(i) would es tablish requirements for use of  a biological soil amendment 
of animal origin treated by a composting pro cess in accordance with the requirements of § 
112.54(c) to meet the microbial standard in § 11 2.55(b) in a manner that minimizes the potential 
for contact with covered produce during and afte r application and with a minimum application 
interval of 45 days. This provision would apply to situations in which the covered produce is 
reasonably likely to contact the soil afte r application of the soil amendment.   
Proposed § 112.56(a)(4)(ii) requires  that if you apply a biologi cal soil amendment of animal 
origin treated by a composting process in acco rdance with the requirements of § 112.54(c) to 
meet the microbial standard in § 112.55(b), and the material is a pplied in a manner that does not 
contact covered produce during or after application, ther e is no minimum application interval.  
This provision would apply to any situation in which the covered produce will not contact the 
soil after application of  the soil amendment.  Although the mi crobial standards and application 
restrictions for biological soil am endments of animal origin treat ed to meet the requirements of 
proposed § 112.56(a)(4) are the same as those de scribed under proposed § 112.56(a)(3), there is 
an additional 45 day application interval for § 112.56(a)(4)(i) that  would not be required in § 
112.56(a)(3).  We have tentativel y concluded that proc ess controls during chemical or physical 295 
 
treatments can be expected to be less prone to  failure than process controls for composting. For 
example, heat treatments are often conducted in en closed heat-treatment chambers (i.e., ovens), 
often with various means of agitation (such as  stirring rods, etc.), that can be accurately 
monitored and controlled to re ach the required treatment cond itions throughout the material 
being treated. Conversely, composting usually o ccurs outdoors, is exposed to fluctuating 
environmental pressures and wild life activity, is not homogeneous in nature and prone to having 
“cold-spots” that are not completely treated (even with proper turning) (Ref. 174).  In general, in 
composting, there is a higher likelihood of having a systems failure, which is also more likely to 
go undetected, should it occur. Composting may resu lt in a treated biolog ical soil amendment of 
animal origin that may continue to har bor human pathogens of food safety concern (Ref. 174), 
although any such hazards that may be present can be expected to be present at low populations 
and unlikely to survive for extended periods  under normal environmental conditions after 
application. Examples of a system failure that  may occur during composting, but would not be 
expected during a thermal or physical treatment , could include animal intrusion, incomplete 
turning, or reduced efficiency of composting du e to environmental or climatic conditions (e.g. 
heavy rainfall or excessive cloud cover reducing th e temperature of the pile or portions of the 
pile). Therefore, we propose to impose an additional mitigation measure in situations where covered produce is reasonably likely to contac t the soil after applic ation of biological soil 
amendments of animal origin treated by compos ting by requiring a minimum application interval 
of 45 days. This time period has been shown to be effective when the population of the pathogen 
is minimal 
(Ref. 92.Ref. 91)(Ref. 198), as can be expected of a fully composted biological soil 
amendment of animal origin. This multiple hurdl e approach and time interval has also been 
utilized in a current industry standard (Ref. 31).  Where a biological soil amendment of animal 296 
 
origin does not contact covered pr oduce either during or after appl ication, we do not believe that 
a minimum application interval is reasonably ne cessary to prevent the introduction of known or 
reasonably foreseeable hazards into covered pr oduce.  Therefore, proposed § 112.56(a)(4)(ii) 
provides for the option to use a biological soil amendment of animal origin treated by 
composting with no minimum waiting period, provi ded the soil amendment is applied in a 
manner that does not contact covered produce duri ng or after application. We seek comment on 
the appropriateness of the proposed application period intervals.   
We have not proposed any provisi ons specific to the status of spent mushroom mulch (growth 
media already used in the production of mushr ooms for subsequent use as a biological soil 
amendment of animal origin in the growing of other covered produce) an d specifically request 
comment on how to classify its status.  The practice of storing spen t mushroom mulch for 
subsequent use in the growing of covered produ ce is not known to be a likely source of 
introduced  contamination because the growth me dia would have been previously treated to 
eliminate pathogens (Ref. 62).  Therefore, we tentatively conc lude that spent mushroom mulch 
previously treated (in accordance with proposed § 112.54(a), to meet the microbial standards of § 
112.55(a)) before use in the growing of mushrooms would still be considered as “treated” to 
meet the standards of § 112.54(c) after use for growing mushrooms, and for any possible subsequent use in the growing of fresh produ ce without any intervening treatment, unless you 
know or have reason to believe it has been othe rwise contaminated with  a hazard or has been 
associated with foodborne illness.  We tentativ ely conclude that spent mushroom mulch should 
be considered, for the purpose of the applic ation requirements in proposed § 112.56, as though it 
has been treated by composting, instead of c onsidering it as though it has been treated in 
accordance with the most robust chemical/physic al treatment process (§ 112.54(a)), though it 297 
 
would have received such a treatment in accord ance with proposed § 112.54(a) before its use to 
grow mushrooms.  This would have the eff ect of subjecting spent mushroom mulch used 
subsequently to grow other covered produce to  the requirement to mi nimize the potential for 
contact with covered produce duri ng and after applicati on, and a minimum application interval of 
45 days.  We consider the weathering process (the common practice of spent mushroom mulch 
being placed in a field in windr ow for further composting over the course of several weeks to 
years) to be similar to  composting in terms of likelihood of introduction of contaminants.  We 
request comment on this tentative conclusion. Under this proposal, you would, in most cases, main tain the flexibility to  choose among a variety 
of treated and untreated soil amendments of an imal origin based on the commodity being grown, 
growing conditions, and other fact ors relevant to your operation, but  you would have to consider 
both the method of application (e.g., whether it would result in contact between the amendment 
and the produce) and, for certain amendments, the interval before harvest.  We would expect you 
to determine which application method is most appropriate for your situ ation by selecting the 
application method and interval restrictions that would coinci de best with your operation, and 
then purchase or treat a biological  soil amendment of animal or igin that meets the corresponding 
specifications (i.e., the first column in the tabl e in § 112.56(a)).  For example, if you intend to 
apply a side-dress of a biological soil amendment of  animal origin close to harvest, you would 
find §§ 112.56(a)(1)(ii), (2), (3), and (4)(ii) have no minimum app lication interval.  You would 
accordingly either use a controlled physical or ch emical process that meets the requirements of § 
112.54(a) and have no further restrictions,  use a controlled physical or chemical process that 
meets the less stringent microbial standards of § 112.54(b) if you can apply the treated biological 
soil amendment of animal origin in a manner that minimizes potential for contact with the 298 
 
covered produce during and after application, or use composted or untreated biological soil 
amendments of animal origin if  you can apply them in a manner that ensures they do not contact 
covered produce during or after ap plication (for example, if you are growing tree crops such as 
oranges, you apply the untreated soil amendmen t without causing it to co ntact the oranges, and 
you do not harvest oranges that have been allowe d to come into contact with the soil after 
application of the soil amendm ent). Conversely, you may determ ine which application method 
and interval is most appropriate by evalua ting which specificati on your biological soil 
amendment of animal origin meets, and then apply it according to th e coinciding application 
method and interval restrictions. If, for exampl e, you wish to apply raw manure to your field, you 
would find the requirements that apply to raw manure in § 112.56(a)(1) and note that, if it is 
reasonably likely that your cove red produce will come in contact  with the soil (for example, 
where almonds are harvested by intentionally dropping to the gr ound) after application of the 
raw manure, the use of raw manure is restricted to  application in a manner that does not contact 
covered produce during application and minimizes the potential for contact with covered produce 
after application, and may be applied no less than 9 months before harvest.  On the other hand, if 
you can apply the raw manure in a manner that ensures it does not contact covered produce 
during or after application, you may use it without a minimum application interval.  Any 
minimum application interval that  you use can be concurrent with  any application intervals that 
you are already required to, or voluntarily, appl y. For example, if you are a USDA-certified 
organic grower, and utilize a 120-day application in terval for the use of raw manure as part of 
participation in the National Organic Program , the proposed 9 month application interval 
requirement in § 112.56(a)(1)(i) would be concurre nt, not consecutive, with the 120 days.  Thus, 
your use of a 9-month application interval for ra w manure would satisfy both this proposed rule 299 
 
and the requirements of the National Organic Progra m.  As another example, if you plan to apply 
a biological soil amendment of animal origin to a field of spinach that is nearing harvest for fresh 
market consumption, assuming the spinach is reasonably likely to contact the soil after application of the soil amendment,  you could select a bi ological soil amendmen t of animal origin 
that is heat-treated to meet the standards presented in § 112.54( b) (e.g., chicken manure pellets), 
provided that you can apply it in a manner that mi nimizes the potential for contact with covered 
produce during and after applicati on (e.g., used as a side-dressing) , because there would not be 
an application restriction interval with that type of biologica l soil amendment of animal origin. If 
you plan to use manure as a biological soil amendment of animal origin for the same crop and plan to apply the amendment before planting, an d do not wish to utilize a treatment such as 
described by §§ 112.54(a) or (b), you would choose to compost the soil amendment to meet the 
requirements of § 112.54(c).  Use of such a biolog ical soil amendment of animal origin would 
only be restricted to applicat ion in a manner that minimizes the potential for contact with 
covered produce during and after ap plication, and applicatio n at least 45 days pr ior to harvest.   
Proposed § 112.56(b) would establis h requirements for the use of alternatives to the minimum 
application intervals establis hed in paragraphs (a)(1)(a ) and (4)(a) of proposed § 112.56, 
provided you satisfy the requirements of § 112.12.  We have tentatively concluded that, under 
certain circumstances, an alternative standard may be appropriate if it is shown to provide the 
same level of public health protection as the standard in proposed § 112.56(a)(1)(i) and (4)(a) 
and not to increase the likelihood that the cove red produce will be adulterated. For example, 
alternatives to the proposed minimum applicat ion intervals could take  into account specific 
characteristics of the locality, crop and the agro- ecological environment.  Such alternatives could 
consider differences in feedstock; application methods; and treatment methods, especially given 300 
 
the potential for new innovations in such methods. In any such case, as discussed below, we 
propose in § 112.60(b)(5) that you establish and keep  documentation of the scientific data and 
information you are relying on to su pport the use of an alternative minimum a pplication interval. 
We do not propose that you would be required to submit such data and information to us for 
prior approval; we do, however, propose the requir ement that you maintain a record of any such 
data and information for us to evaluate upon request. h. Records requirements 
Proposed § 112.60(a) requires that you estab lish and keep records for subpart F in 
accordance with the requirements of subpart O of this part.  Proposed § 112.60(b) would 
establish requirements for records you must establish and keep regarding biological soil 
amendments of animal origin that you use.  Proposed § 112.60(b)(1) would require 
documentation of the date of application of a ny untreated biological soil amendment of animal 
origin (including raw manure) or  any biological soil amendment of animal origin treated by 
composting to a growing area and the date of ha rvest of covered produce from that growing area, 
except when covered produce does not contact the soil after application of the soil amendment. 
These records would be required because the ap plication of both raw manure and compost 
include minimum application intervals (§ 112.56(a)(1 )(i) and (4)(i), respec tively), so it would 
enable FDA to verify compliance with the application intervals associated with raw manure and compost.  These records would also allow you to keep track of th e dates on which those 
biological soil amendments of animal origin were  applied in order to determine when covered 
produce from those growing areas  could be harvested in comp liance with the rule. . USDA-
certified organic growers who alr eady maintain records of when bi ological soil amendments of 301 
 
animal origin are applied in compliance with  7 CFR 205.103 would not need to duplicate those 
records to meet the requ irements of § 112.60(b)(1). 
Proposed § 112.60(b)(2) would require documentation (such as a Certificate of Conformance) 
for a treated biological soil amendm ent of animal origin that you receive from a third party. We 
have tentatively concluded that the information you will need both to verify that any biological 
soil amendment of animal origin you purchase fo r use in performing a c overed activity is in 
compliance with this subpart F, and to inform your decisions on furthe r handling, conveying, and 
storing of the purchased biological  soil amendment of animal orig in, includes the following: (i) 
the process used to treat the biological soil amendment of animal origin is a scientifically valid process that has been carried out with appropriate process m onitoring; (ii) the applicable 
treatment process is periodically verified through testing using a scientifically va lid analytical 
method on an adequately represen tative sample to demonstrate that the process satisfies the 
applicable microbial standard in § 112.55, including th e results of such period ic testing; and (iii) 
the biological soil amendment of animal origin has been handled, conveyed and stored in a 
manner and location to minimize the likelihood of contamination by an unt reated or in-process 
biological soil amendment of animal origin.  Asp ects (i) and (iii) of th is proposed requirement 
reflect information that you woul d have if you treated the biologi cal soil amendment of animal 
origin on your own farm in accordance with this proposed rule.  Aspect (ii) of this requirement would provide you with reasonable assurances that your supplier is  carrying out the applicable 
treatment process in an effectiv e manner such that the biological soil amendment of animal 
origin that you purchase meets the applicab le standards in proposed §§ 112.54 and 112.55.  We 
tentatively conclude that  it is appropriate to re quire this additional leve l of assurance from your 
suppliers in order to allow FDA to verify your compliance with these requirements. These 302 
 
requirements will also provide you with a compar able level of control over your supplier’s 
process of treating a biological soil amendment of animal origin  as you would have if you were 
to apply the treatment process on-farm, where you w ould be able to monitor the process controls 
yourself.  You would not be requ ired to perform any treatment processes on a biological soil 
amendment of animal origin that you purchase and for wh ich you have the appropriate 
documentation showing it has already been treated  by a validated process in accordance with § 
112.55.  These records would also allow you to ensu re that a treated biological soil amendment 
that you purchase from a third party meets th e requirements of this proposed rule and to 
determine the relevant application restrictions you must apply to such  a soil amendment.  
Proposed § 112.60(b)(3) would require documentation th at process controls (for example, time, 
temperature and turnings) were achieved for any treated biologi cal soil amendment of animal 
origin you produce for your own covered farms. This  documentation is require d to verify that the 
treatment or treatments you performed were prop erly carried out.  For example, such records 
would inform you of any breakdown in the process or treatments, how they occurred or can be 
corrected, and create a history to help you predict and prevent any future breakdowns. Without 
such records, you would not be able to ensure, and we would not be able to verify, that the 
process or treatment you performed achieved the re quired parameters that are validated to meet 
the microbial standards of § 112.55 or that the al ternatives that you are using (if applicable) 
satisfy the requirements of proposed § 112.12.  Proposed § 112.60(b)(4) would require documentation of  scientific data or information you rely 
on to support any alternative com posting process used to treat a biological soil amendment of 
animal origin in accordance with the requirements of § 112.54(c)(3).  Similarly, proposed § 112.60(b)(5) would require documentation of scien tific data or information you rely on to 303 
 
support any alternative minimum ap plication interval in accordance with the requirements of § 
112.56(b). The records described in §§ 112.60(b)(4 ) and (5) would be required only if you 
choose to use alternatives to those proce sses presented in §§ 112.54(c)(1) and (c)(2) or 
application intervals in 112.56(a)(1 )(i) and (a)(4)(i), respectivel y. This documentation would be 
required so that, as necessary, we are able to veri fy that use of your alte rnative process achieves 
the required parameters of proposed subpart F and satisfies the requirements of proposed § 
112.12. 
Finally, we seek comment on an issue that is  not explicitly addressed in our proposed 
provisions.  Biological soil amendments (inclu ding agricultural teas de rived from biological 
materials) are nutrient rich a nd may support rapid and prolific growth of human pathogens, if 
pathogens are present.  Seeds used for sprouting have repeatedly been demonstrated to have the 
potential to be contaminated w ith human pathogens and cause human illnesses.  We note that the 
National Organic Standards Board Compost Tea Task Force recommended not allowing for the 
use of "compost tea" for the pr oduction of edible seed sprouts (Ref. 36).  We are concerned that 
using a biological soil amendment (i ncluding agricultural teas deri ved from biologi cal materials) 
could increase the likelih ood of rapid and prolific growth of human pathogens, if present, during 
sprout growing.  We request comment on whet her sprouters currently  use biological soil 
amendments (including agricultural teas made from  biological materials, such as "compost teas") 
in the growing of sprouts.  In addition, we re quest comment on the likelihood of contamination 
presented by such a practice and whethe r the practice should be prohibited. 
 
G. Subpart G – We have tentatively rese rved subpart G of this proposed rule. 
 304 
 
H. Subpart H – We have tentatively rese rved subpart H of this proposed rule. 
 
I.  Subpart I – Standards Directed to Domesticated and Wild Animals  
As proposed, subpart I provides science-based minimum standa rds that are directed to 
domesticated and wild animals and are reasonabl y necessary to minimize the risk of serious 
adverse health consequences or death from the use of, or exposur e to, covered produce, including 
those 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 
adulterated under section 402 of the FD&C Act. 
1. Comments Related to  Proposed Provisions  
We received several comments in response to th e 2010 FR notice that addressed issues relevant 
to standards directed to dome sticated and wild animals.  Some comments expressed concern 
about requiring measures that prohibit the use of  domesticated work animals on farms.  Some 
comments asserted that monitori ng wildlife in a farm environmen t is untenable, whereas other 
comments recommended that we prepare a list of “animals of concern” to enable farmers to 
know where to target preventive controls for dom esticated and wild animals.  Some comments 
recommended that sustainable conservation practices should be adopted and recognized as 
enhancing food safety.  Several comments noted that farmers are subject to State and Federal 
laws regarding wildlife (e.g., Endangered Species Act and Clean Water Act)  and that there are 
programs that emphasize environmental stew ardship (e.g., National Organic Program and 
programs of the Natural Resources Conservation Se rvice).  Others expressed concern about any 
requirements that would lead to destructi on of habitat or clearing of farm borders. 305 
 
This proposed rule would not prohi bit the use of on-farm domesticat ed working animals.  Rather, 
this proposed rule would require you to take meas ures to prevent the in troduction of known or 
reasonably foreseeable hazards into or onto c overed produce, if you use working animals in a 
growing area where a crop has been planted and when, under the circumstances, there is a 
reasonable probability that animals will contam inate covered produce.  We disagree with 
comments that asserted that monitoring for anim al intrusion is untenab le.  Periodic monitoring 
for animal intrusion and deposition of their excreta is a necessary measure to prevent 
contamination of covered produce with biological food safety hazards when there is a reasonable 
probability that animals will cont aminate covered produce.  We consider that monitoring during 
the growing season and immediatel y prior to harvest is a prac tical and minimum necessary 
standard to sufficiently ensure that any potential hazards related to animal intrusion are identified 
for appropriate follow-up actions in these situ ations.  Proposed § 112.83 is intended to provide 
you with information about animal movements on your farm, allow you to recognize si gnificant 
intrusion, and facilitate your taking appropriate measures follo wing significant animal intrusion.   
While we recognize the value of establishing a list of “animals of concern,” we tentatively 
conclude that current scientific evidence on th e extent to which specific animals present the 
greatest risk for pathogens is inadequate to deve lop such a list.  Moreover, data on regional and 
seasonal variations in the preval ence of pathogens in different kinds of animals are scarce.   
We encourage the application of practices that  can enhance food safety, including sustainable 
conservation practices.  A set of examples of biodiversity and conserva tion practices that may 
enhance food safety is available from the Res ource Conservation District  of Monterey County, 
CA (Ref. 199).  This proposed rule would not require the destruction of habita t or the clearing of 
farm borders.  Instead, we propos e to require you to monitor t hose areas that are used for a 306 
 
covered activity for evidence of animal intr usion when, under the circumstances, there is a 
reasonable probability that animals will contaminate covered produce. 
2.  Proposed Requirements 
Proposed subpart I includes standa rds that would be directed to  the potential for biological 
hazards from animal excreta to be deposit ed 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 anim als (such as deer and wild swine) on covered 
produce or in an area where you conduct a cove red activity on covered produce.  Proposed 
subpart I would not be directed to the potential for biological hazards from manure that may be 
used as a soil amendment; such requirements dire cted to biological soil amendments of animal 
origin are discussed in sec tion V.F of this document. 
Consistent with sections 419(a) (1)(A), 419(a)(3)(E), and 419(a)(3 )(D) of the Act, we consulted 
with USDA’s National Organic Program and Natura l Resources Conservation Service, U.S. Fish 
and Wildlife Service, and the EPA (Ref. 115) to ensure that environmental and conservation 
standards and policies es tablished by those agencies are appr opriately considered in developing 
the requirements proposed in this subpart.  Base d on these consultations, we tentatively conclude 
that the provisions of proposed subpart I do not conflict with or duplicate the requirements of the 
National Organic Program.  In addition, also based on these consultations, we tentatively 
conclude that the provisions of proposed subpart I are consistent  with existing conservation and 
environmental practice standards and policies wh ile providing for enfo rceable public health 
protection measures.  Furthermore, the provisions  in proposed subpart I are consistent with 
current recommendations in our GAPs Guide (Ref. 10), the AFDO Model Code (Ref. 20), 
Commodity-specific industry guidances (Ref. 44.Ref. 46), and the LGMA (Ref. 31). We seek 307 
 
comment on the interactions of the proposed rule with the National Organic Program and 
opportunities to streamline compliance with both programs.  We acknowledge the longstanding co-locati on of animals and plant food production in 
agriculture.  However, as discu ssed in the QAR, both wild and do mestic animals may be a source 
of human pathogens.  In fact, domesticated animal s, due to their close proximity and interaction 
with humans, are generally more likely to har bor zoonotic pathogens than are wild animals 
(Ref. 
200).  Therefore we tentatively conclude that measures should be taken to minimize the 
likelihood of covered produce being contaminated by excreta from grazing and working animals.  
The likelihood of contaminating fresh produce w ith human pathogens from excreta from grazing 
and working animals is determined by numerous factors, including but no t limited to the species 
of the animal, the number of animals per unit area of land, agro-ecologi cal conditions, and the 
time period between animal grazing or working in fields and the harvest of fresh produce (Ref. 
176.Ref. 169.Ref. 201.Ref. 202). 
Proposed § 112.81(a) would establis h that the requirements of pr oposed subpart I apply when a 
covered activity takes place in an outdoor area or a partially-enclosed building and when, under 
the circumstances, there is a reasonable probabi lity that animals will contaminate covered 
produce.  We have tentatively concluded that measures directed to domesticated and wild 
animals (such as cows, swine, and deer) are nece ssary when a covered activity takes place in an 
outdoor area or a partially-encl osed building if, under the circum stances, there is a reasonable 
probability that animals will cont aminate covered produce, because it is reasonably likely that 
such animals will encroach on such areas and de posit excreta on covered produce or food contact 
surfaces.  Some human pathogens of public health concern (e.g., E. coli  O157:H7) that have been 
associated with produce foodborne outbreaks are zoonotic, meaning th at they may originate from 308 
 
animals as well as humans.  Therefore, animal s, both wild and domestic, may be a source of 
human pathogens during the growing, harvesting, packing and holding of covered produce.  We 
expect this provision to provide flexibility for farmers to consid er the nature of covered produce 
and covered activities (including ch aracteristics of covered produce)  in light of the potential for 
contamination, and determine whether the pr oposed requirements of subpart I would be 
applicable under the circumstan ces.  For example, in the case  of covered produce that grows 
completely underground, we expect that ther e would not be a reasonable probability of 
contamination of covered produce by domestic ated or wild animals that may graze on or 
encroach into fields.  The proposed require ments in §§ 112.82 and 112.83, therefore, would not 
apply to covered activities taking place in an out door area or a partially- enclosed building when 
such activities relate to covered produce that  grows completely underground.  We note, however, 
that we do not intend the phrase “under the circ umstances” in these proposed requirements to 
suggest that farms alter their su rrounding environment in order to reduce the chances of animal 
intrusion, such as by clearing farm borders aroun d outdoor growing areas or  drainages.  This 
proposed rule is not intended to require su ch actions.  We inte nd the phrase “under the 
circumstances” to refer to the nature of the c overed produce (such as its growth habit) and the 
nature of covered activities (suc h as the manner in which working animals are used in growing 
areas).  We request comment on this issue.  Proposed § 112.81(b) would provide th at the provisions of proposed subpart I would not apply to 
fully enclosed buildings.  We te ntatively conclude that the meas ures proposed in this section 
directed to domesticated and wild animals (such as cows, dogs, swine, and deer) are not 
necessary when a covered activity  takes place in a fu lly-enclosed building.  Rather, we propose 309 
 
measures directed at domesticat ed and wild animals (such as horses, dogs, and rodents) in a 
fully-enclosed building in proposed § 112.127 (s ee section V.L. of this document).  
Proposed § 112.82 would establish re quirements for measures that you must take, at a minimum, 
if you allow animals to graze or use them as wo rking animals in fields where you grow covered 
produce and under the circumstances  there is a reasonable probab ility that grazing or working 
animals will contaminate covered produce.  Proposed § 112.82(a) would require you to 
implement an adequate waiting period between grazing and time of harvest for covered produce 
in any growing area that was graze d, to ensure the safety of th e harvested crop.  The potential 
likelihood of animals to act as vectors of human pathogens is determined by several factors, 
including but not limited to the type of commodity (as discussed above), and the species of the 
animal and its association with human or domesticated animal activity or waste (Ref. 199).  A 
suitable time period based on these and other relevant factors must  be established for the purpose 
of reducing, via die-off, pathoge n levels in the excreta that may be transferred to covered 
produce.  We would not expect it to be necessa ry for such time periods to exceed 9 months, 
which is the application interval we propose for use of raw manure as a soil amendment in 
proposed § 112.56(a)(1)(i).   Proposed § 112.82(b) would require that, if you use working animals in a growing area where a 
crop has been planted, you must take measur es to prevent the in troduction of known or 
reasonably foreseeable hazards into or onto c overed produce.  For example, if you use draft 
horses as working animals in your covered produ ce fields, you could establish and use horse 
paths which are segregated from covered produ ce plantings, and minimize entry of the horses 
into covered produce plantings, thus minimizing the opportunity for horse excreta to contact 
covered produce or food contact surfaces.   310 
 
Proposed § 112.83 would establish requi rements for measures related to animal intrusion in those 
areas that are used for covered activities for covered produce wh en under the circumstances there 
is a reasonable probability that animal intrus ion will contaminate covered produce.  We are 
proposing to require that you monitor these ar eas as needed throughout  the growing season, 
based on the covered produce being grown and your observations and experiences (proposed § 
112.83(a)(1)(i) and (ii)), and im mediately prior to harvest (proposed § 112.83(a)(2)).  In 
proposed § 112.83(b) we would also require that, if animal intr usion occurs, as evidenced by 
observation of significant quantities  of animals, animal excreta or crop destruction via grazing, 
you must evaluate whether the covered produce can be harvested in accordance with the 
requirements of proposed § 112.112.  We acknowledge that when covered produce is grown in an outdoor environment, wild animals are likely to have access to produc tion fields.  The presence of animals in a production field of 
covered produce, in and of itself, is not a signif icant food safety risk.  However, wild animals are 
known zoonotic disease reservoirs for human pathogens, and therefore their excreta may 
contaminate growing covered produce crops 
(Ref. 169.Ref. 203).  Monitoring immediately prior 
to harvest will enable you to identify inst ances when covered produce cannot be safely 
harvested, such as when it is not possible to eff ectively avoid the harvest of covered produce that 
was directly exposed to animal excreta or that  may be cross-contaminated during harvest (e.g., 
contamination of covered produce by contact with  a food-contact surface that contacted animal 
excreta), as provided for in proposed § 112.112. 
Monitoring throughout the growing season may a ssist you in developing an understanding of 
when and the degree to which animal intrusion o ccurs throughout the production season from 
planting to harvest.  This proposed provision should  not be construed to re quire the “taking” of 311 
 
an endangered species, as the term is defined in the Endangered Species Act (16 U.S.C. 
1532(19)) (i.e., to harass, harm, pursue, hunt, shoot,  wound, kill, trap, capture , or collect, or to 
attempt to engage in any such conduct), or to re quire farms to take measures to exclude animals 
from outdoor growing areas or destroy animal habitat or otherwise clear farm borders around 
outdoor growing areas or drainages.   
  J. Subpart J – We have tentatively re served subpart J of this proposed rule. 
 
K. Subpart K – Standards Directed to Growing, Harvesting, Packing, and Holding 
Activities As proposed, subpart K discusses science-base d minimum standards directed to growing, 
harvesting, packing, and holding activities that are reasonably necessary to minimize the risk of 
serious adverse health consequen ces or death from the use of, or exposure to, covered produce, 
including those reasonably necessary to pr event the introduction of known or reasonably 
foreseeable hazards into covered produce, and to  provide reasonable assurances that the produce 
is not adulterated under s ection 402 of the FD&C Act. 
1. Comments Relevant to  the Proposed Provisions 
We received some comments in response to the 2010 FR notice that addressed the adequacy and 
cleanliness of food-packi ng material and requested that reus able containers be allowed in 
packing produce commodities.   It is important to ensure that f ood-packing material that is used in covered activities is adequate 
for its intended use, including that it is cl ean.  In proposed § 112.116 below, we address the 
adequacy and cleanliness of f ood-packing material.  Specifi cally, proposed § 112.116(b) would 312 
 
require that if you reuse food-packing material, yo u take measures to ensure that food-contact 
surfaces are clean, such as by cleaning and sani tizing, when necessary, food-packing containers 
or using a clean liner.   2. Proposed Requirements  Proposed § 112.111 would establis h that if you grow, harvest, pack or hold produce that 
is not covered in this part (i.e., excluded pr oduce 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 pa rt, you must take measures duri ng these covered activities, as 
applicable, to: (a) Keep c overed produce separate from excluded produce (proposed § 
112.111(a)); and (b) Adequately clea n and sanitize, as necessary, any food-contact surfaces that 
contact excluded produce before using such f ood-contact surfaces for covered activities on 
covered produce (proposed § 112.111(b)).  As di scussed in the QAR, raw produce may have a 
variety of microorganisms in and on it, includi ng, occasionally, human pathogens.  The types of 
microorganisms, including human pathogens, det ected on raw produce are diverse and may often 
be found in high numbers 
(Ref. 204.Ref. 205.Ref. 206).  In addition, some human pathogens that 
are commonly isolated from the grow ing environment (e.g., L. monocytogenes ) are reported to 
adapt and survive in the food production environm ent (e.g., food contact surfaces, floors, walls, 
drains, sinks, standing water, a nd seals) and, thus, pose a poten tial source of contamination (Ref. 
207).  The proposed standards included  in this part are designed to reduce the likelihood that 
human pathogens are present in or  on covered produce.  For this reason, excluded produce that is 
not grown, harvested, packed and stored in accordan ce with the standards propos ed in this part is 
likely to present a greater like lihood of contamination with huma n pathogens than would covered 
produce that is grown, harvested, packed, and held in accordance with this part.  We tentatively 313 
 
conclude that for operations handling both covere d and excluded produce, cross-contamination is 
reasonably likely in the absence of measures di rected toward its prevention.  Such measures 
include separation of the two types of produce to  avoid physical contact and any transfer of 
pathogens from one to the other; and cleaning an d sanitizing, as necessar y, food contact surfaces 
used on such excluded produce before those surfaces come in contact with covered produce so that any pathogens picked up by the food-c ontact surface from excluded produce are not 
transferred to covered produce.   
Proposed § 112.112 would require you to take all measures reasonably necessary to 
identify, and not harvest, covered produce that is  reasonably likely to be contaminated with a 
known or reasonably foreseeable hazard, including  steps to identify and not harvest covered 
produce that is visibly contaminated with animal  excreta.  For example, you would comply with 
this provision by not harvesting a head of lettuce if you see evidence of bird excreta on the head 
of lettuce.  As discussed in the QAR, it is well established that animal excreta is a source of 
pathogens.  Transmission of pathogens from  animal excreta to covered produce and, 
subsequently, to humans through consumption is reasonably likely in cases where the presence 
of animal excreta can be visually  confirmed.  Therefore, if the pr esence of animal excreta in a 
field of covered produce precludes your ability to safely harvest the covered produce, either 
because a significant portion of the covered pr oduce has animal excreta on it or because the 
animal excreta that is present would be likely to contaminate f ood contact surfaces of harvest 
equipment, you must not harvest the relevant portions of that field.  
Proposed § 112.113 would require that you handle  harvested covered produce during covered 
activities in a manner that prot ects against contamination with known or reasonably foreseeable 
hazards, for example, by avoiding contact of cut surfaces of harvested produce with soil.  As 314 
 
discussed in the QAR, research demonstrates  that soil microorganisms, including human 
pathogens, may effectively colonize produce when  the produce has lost its protective covering 
(e.g. cuticle) in the course of harvest activities (e. g., cutting or trimming) or when damaged 
during such operations (Ref. 208.Ref. 209).  Once established, the high moisture content of 
produce provides a suitable environment for surviv al and growth of such pathogens.  Pathogens, 
if present, may be transferred to cut surfaces of harvested pr oduce from soil and, therefore, 
preventing unnecessary contact between such cu t surfaces and soil will reduce the likelihood of 
such transfer.  For example, you could take step s to temporarily place cut lettuce heads on clean 
cardboard or other clean surface dur ing field packing, rather than placing them directly on the 
soil.   We considered washing as a requirement to re duce the likelihood of contamination.  Washing is 
an attractive option because it effectively remove s excess dirt, debris, and other organic matter 
and its use incurs a relatively low cost allowing it to be employed across a variety of equipment 
(water flumes, hydrocoolers, dips, scrubbers, sort ers, etc.) or steps in combination, or in 
sequence before packaging. Despite these advantag es, a number of studies have concluded that 
wash water, with or without an active antimicr obial agent, does not comp letely disinfect produce 
that may contain microorganisms  of public health significance 
(Ref. 206.Ref. 210.Ref. 209).  
Wash water containing an antimicrobial such as chlorine is reported to reduce microbial 
populations by two or three log units (100 to 1000 fold), but does not eliminate microbes (Ref. 
211.Ref. 210).  Bacteria may find harborage and pr otection on plants through hydrophobic areas, 
stomata, lenticels, punctures, and bruises and where it is not readily washed off (Ref. 212.Ref. 
213).  Of special significance to bacterial surviv al on plants are circumstances that lead to 
bacterial cells being drawn in or internalized in side the edible portion of the plant where they 315 
 
may escape the action of water altogether.  This  phenomenon, termed inte rnalization, may occur 
as a consequence of temperature differentials created when warm produce (from field heat or 
daytime high temperatures) is submerged in cooler water.  Under these conditions, infiltration of water occurs because intercellular air spaces w ithin fruits and vegetables contract, thereby 
creating a partial pressure differential that draws the water into the internal compartments of the plant.  If the cooling water contains huma n pathogens the fresh produce item will now be 
internally contaminated.  This  phenomenon has been seen with Salmonella and E. coli O157:H7 
in tomatoes, oranges, or mangoes 
(Ref. 138.Ref. 139.Ref. 214).  As part of a post-outbreak study, 
Penteado et al. 2004 reported evidence that Salm onella spp. may have in ternalized in fresh 
mangoes during a postharvest cooli ng step involving a water bath (Ref. 38).  We seek comment 
on whether we should consider wa shing, alone or in combination with other measures, as a 
requirement to reduce the lik elihood of contamination.  
Proposed § 112.114 would prohibit you from distri buting 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).  Dropped covered produce does not include root crops (such as carrots) that 
grow underground or crops (such as cantaloupe) that grow on the ground.  However, produce 
that grows off the ground, such as tomatoes a nd apples, and that drop to the ground before 
harvest would be considered dropped covered pr oduce.  Evidence from studies of tree fruit (e.g., 
apples and pears) indicates th at dropped and damaged fruit contain coliform bacteria in 
significantly higher numbers than intact tree fruit (Ref. 215).  Risk assessment models for apple 
contamination (Ref. 216) show that dropped apples are more likely to be contaminated with 
bacteria than tree-picked apples , and dropped fruit used in the pr oduction of apple products (e.g., 316 
 
apple cider) are likely  to increase rates of  product contamination (Ref. 216)).  While data 
available to us is primarily de rived from studies investigating a pples, we tentatively conclude 
that all dropped covered produce is likely to present a poten tial likelihood for contamination, 
although to varying degrees.  Studi es have indicated that when produce drops to the ground, the 
produce can become structurally damaged, which is c onsidered to be a factor for proliferation of 
human pathogens on such produce (Ref. 217.Ref. 218.Ref. 219).  Excluding dropped fruit from 
harvest is also recommended in some existing guidance documents (Ref. 220.Ref. 221.Ref. 44).  
However, some produce is dropped to the ground as  a part of the harvesting practice (e.g., some 
tree nuts).  We expect that such harvesting pr actices were developed because the fall does not 
damage the edible crop, because the crop is prot ected with a durable shell.  Accordingly, we 
have defined “dropped covered produce” to exclude  produce that is inten tionally dropped as part 
of harvesting.  Further, we do not propose to pr ohibit the use of dropped covered produce in a 
commercial process (e.g., canning)  that is designed to adequa tely reduce the presence of 
microorganisms of public health significance.  Therefore, dr opped covered produce that is 
exempt under proposed § 112.2(b) may be distributed for such commercial processing as 
described in proposed § 112.2 (see sec tion V.A. of this document).   
We seek comment on this provision and whether specific commodities should be 
exempted from this provision based on the harv esting practices associated with the commodity 
and/or the nature of the commodity itself.  If sp ecific commodities should be exempted from this 
provision, please explain the practice s, processes, and conditions a ssociated with that commodity 
that would justify such exemption.  We expect that this proposed pr ovision would prevent the 
marketing for fresh use of produce that may have b een bruised as a result of the fall.  As noted 
above, damaged or bruised fruit provide an opport unity for pathogen intrusion into the edible 317 
 
portion and may liberate nutrients for pathogen growth.  We note that produce that is 
intentionally dropped to the ground as part of the harvesting me thod would not be considered 
“dropped covered produce” as defined in proposed § 112.114 (i.e., produce that drops to the ground before
 harvest).  We seek comment on whethe r proposed § 112.114 adequately takes into 
account produce that is intent ionally dropped during harvesting and whether such harvesting 
practices do not cause damage to the produce. Proposed § 112.115 would establish measures that 
you must take when packaging covered pr oduce.  Specifically, proposed § 112.115 would 
require that you package covered produce in a manne r that prevents the formation of Clostridium 
botulinum  toxin, if such toxin is a known or re asonably foreseeable hazard (such as for 
mushrooms).  The potential for toxin production by C . botulinum  in mushrooms packaged under 
reduced oxygen conditions is well-known (Ref. 222).  Mushrooms grow close to the ground, 
which is a source of C. botulinum  spores.  Mushrooms remain meta bolically active after harvest, 
which may quickly reduce the amount of oxygen, pa rticularly when mushrooms are packaged 
under conditions that limit the transfer of oxygen across the layer of packaging (Ref. 223).  In 
such reduced oxygen or anoxic conditions, C. botulinum  spores can germinate resulting in the 
formation of botulinum toxin, which can occur be fore any overt signs of mushroom spoilage 
(Ref. 222). Modified or reduced-oxygen packaging of  other produce may present a similar risk 
for botulinum toxin formation (Ref. 224). Perforated packaging film allows free air access to 
mushrooms and is recommended as a means to reduce the potential for toxin formation in 
mushrooms (Ref. 225).  Other means of preventing toxin formation in modified or reduced 
oxygen packaging may include use of time-temper ature integrators on individual packages of 
produce to signal when a cumulative time-temper ature combination has been reached that 
presents a risk for C. botulinum  toxin formation or use of antimicrobial compounds (Ref. 224). 318 
 
We request comment on the need for this propo sed provision and on the t ypes or conditions of 
modified or reduced oxygen packaging methods that may or may not increase the risk of 
formation of botulinum toxin. 
Proposed § 112.116 would establish measures that you must take when using food-
packing (including food packaging) material.  Specifically, proposed § 112.116(a) would require 
that food-packing material must be adequate fo r its intended use.  For example, food-packing 
material that would be adequate for its intended use include plastic bins for holding fresh-picked 
fruit, wax-impregnated corrugated cardboard for br occoli to be hydrocoole d or top-iced after 
packing, plastic clamshells used for packaging strawberries for retail sale, and single-use 
cardboard containers for packing tomatoes.  Wooden bins or boxes, and canvas bags that may be 
used during harvest also would need to meet th is requirement, and could be used if they are 
adequately clean and sanitary for their intended use.   To implement this provision, you would 
have to use food-packing materials that are: (1) cleanable or designed for single use and (2) 
unlikely to support growth or transfer of bacteria. In addition, proposed § 112.116(b) would 
require that if you reuse food-packing material, yo u take measures to ensure that food-contact 
surfaces are clean, such as by cleaning and sani tizing, when necessary, food-packing containers 
or using a clean liner.  Evidence from scien tific literature indicates that the number of 
microorganisms detected on the surface of fruits is  directly correlated to the amount of contact 
time between the fruit commodity and its packing material (Ref. 226.Ref. 227).  Although some 
food-packing material is sufficiently sturdy to be  used multiple times, it may serve as a source of 
contamination in the absence of regular cleaning and sani tizing between each such use.  Further, 
certain food-packing material may have a servic eable shelf life beyond which it may not possible 
to effectively clean and sanitize th e material.  It is reasonably likel y that such packing material, if 319 
 
it continues to be used, may serve as harborage sites for pathogens, if they become established on 
its surface.    
L.  Subpart L – Standards Directed to E quipment, Tools, Buildings, and Sanitation 
Proposed subpart L establishes science-based mini mum standards that are reasonably necessary 
to prevent equipment, tools, buildings, and in adequate sanitation from introducing known or 
reasonably foreseeable hazards into or onto c overed produce or food-cont act surfaces, and to 
provide reasonable assurances th at the covered produce is not adulterated under section 402 of 
the FD&C Act.   A few comments recommended that equipment used to hold or convey water should be inspected 
to ensure that it is clean.   We agree that equipment used to hold or convey water should be maintained in a manner 
necessary to protect against c ontamination.  In 112.42 (b), we would require that you must 
adequately maintain all agricultu ral water sources that are unde r your control (such as wells) by 
regularly inspecting each source and keeping th e source free of debris, trash, domesticated 
animals, and other possible sources of contaminat ion of covered produce to the extent practicable 
and appropriate under the circumstances. In 112.42 (c), we would require that you must 
adequately maintain all agricultural water distri bution systems as necessary and appropriate to 
prevent the water distribution system from bei ng a source of contamination to covered produce, 
food-contact surfaces, areas used for a covered activity, or water sources, including by regularly 
inspecting and adequately storing al l equipment used in the system. 
 
1. Comments Relevant to  Proposed Provisions  320 
 
We received some comments in response to the 2010 FR notice that expressed that the 
use of animals on a farm or their presence near  farming operations should not be prohibited. 
We address issues related to animals in a nd around farming operations in subpart I (see 
section V.I. of this document) of this rule.  Ho wever, in this subpart, we  address the presence of 
animals in fully-enclosed buildings.  Speci fically, proposed § 112.127 would require that you 
take reasonable precautions to prevent domesticat ed animals, including guard and guide dogs, in 
and around a fully-enclosed building from c ontaminating covered produce, food-contact 
surfaces, and food packing materials with know n or reasonably foreseeable hazards.  
2. Proposed Requirements 
a. Equipment, tools, and build ings that are subject to the requirements of this subpart 
Any equipment and tools used during covered acti vities that are intend ed to, or likely to, 
contact covered produce would be subject to proposed subpart L.   In addition, instruments or 
controls used to measure, regulate, or record conditions to control or prevent the growth of 
undesirable microorganisms or other contamination would be subject to proposed subpart L.  In 
proposed § 112.121, we provide examples of such e quipment and tools, i.e., knives, implements, 
mechanical harvesters, waxing machinery, cooli ng equipment (including hydrocoolers), grading 
belts, sizing equipment, palletizing equipment, and equipment used to store or convey harvested 
covered produce (such as cont ainers, bins, food-packing material, dump tanks, flumes, and 
vehicles or other equipmen t used for transport).   
Proposed § 112.122 would identify the types of  buildings that are subject to the 
requirements of proposed subpart L.  Such bu ildings would include any fully- or partially-
enclosed buildings used for covered activities, in cluding minimal structures that have a roof but 
do not have any walls (proposed § 112.122(a)).  Fully-enclosed build ings are typically used to 321 
 
grow covered produce such as sprouts and mushro oms and may be used to grow a variety of 
covered produce indoors to create or extend the gr owing season in a particular geographic area.  
Partially-enclosed buildings can be used to gr ow covered produce such as tomatoes, and are 
often used to pack covered produce.  Buildings th at are subject to the requirements of the rule 
would also include storage sheds, buildings, or  other structures used to store food-contact 
surfaces (such as harvest containers and food- packing materials) (proposed § 112.122(b)).  We 
are proposing this requirement because contam inated food-contact surfaces can contaminate 
covered produce (Ref. 182)(Ref. 228) and, thus, present a potential hazard. 
b. General requirements applicab le to equipment and tools 
As proposed, § 112.123 establishes ge neral requirements applicab le to equipment and tools 
subject to subpart L. Proposed § 112.123(a) would require you to use equipment and tools that 
are of adequate design, construction, and workmanshi p to enable them to be adequately cleaned 
and properly maintained.  For example, some lettu ce coring knives currently used in the industry 
are designed in a way that gives them the propensity  to transfer microbial contaminants from soil 
to the lettuce (Ref. 229).  Using a tool that is designed to minimize the potential for pathogen 
transfer from soil to the produce and/or that allows for mechanic al polishing to facilitate cleaning 
and sanitizing the tool w ould enhance food safety (Ref. 230).  
 Proposed § 112.123(b)(1) would esta blish that equipment and tool s you use must be installed 
and maintained in a manner that facilitates cleani ng of the equipment and of all adjacent spaces. 
For example, equipment that is permanently in stalled in an on-farm packing operation would 
need to be installed in such a manner that both maintenance and cleaning crews are able to easily 
access any food contact surfaces, prot ective covering or barriers, a nd any movable parts or other 
potential sources of contaminati on.  A conveyor belt system that is  part of a grading line would 322 
 
be considered properly installed if there is eas y access to the belt (a food-contact surface) for 
cleaning.  The proposed provisions in § 112.123(b)(1) are consistent with the requirements in 
current § 110.40(a) and § 111.27(a). Proposed § 112.123(b)(2) would establish that equi pment and tools you use must be stored and 
maintained to protect covered produce from be ing contaminated with known or reasonably 
foreseeable hazards and to prevent the equipment and tools from attracting or harboring pests.  
As discussed in the QAR, if farm equipment or tool s are stored outside or in a partially-enclosed 
building, they may attract or harbor pe sts, which can carry human pathogens 
(Ref. 231).  
Appropriate practices for stori ng and maintaining equipment and tools can reduce the potential 
for these problems.  For example, you would co mply with this provisi on by storing equipment 
and tools indoors when practical, and when not  practical, minimizing surrounding debris and 
checking periodically for pests. Proposed § 112.123(c) would establish that seam s on food-contact surfaces  of equipment and 
tools that you use must be either smoothly bonde d, or maintained to minimize accumulation of 
dirt, filth, food particles, and organic material and thus mini mize the opportunity for harborage 
or growth of microorganisms.  This provision is consistent with current § 110.40(a) and (b) and § 
111.27(a).  Proposed § 112.123(d)(1) would require you to insp ect, maintain, and clean and sanitize (when 
necessary and appropriate) all f ood-contact surfaces of equipmen t and tools used in covered 
activities as frequently as reasonably necessary  to protect against c ontamination of covered 
produce.  This provision is intended to prevent tr ansfer of contaminants on food-contact surfaces 
of equipment or tools (e.g., harvest knives, grad ing belts, or harvest bins) to covered produce.  
As discussed in the QAR, for example, it has been documented that E. coli
 O157:H7 can be 323 
 
transferred to Iceberg lettuce from contaminated  coring devices used in a simulated field coring 
(Ref. 229).  Even food contact surfaces made of stainless steel can tr ansfer pathogens to covered 
produce, if not properly cleaned a nd sanitized.  For example, transf er of pathogens from stainless 
steel tools to lettuce has been demonstrated to occur to various extents, depending on the amount 
of water on the leaf surface (Ref. 232). 
Proposed § 112.123(d)(2) would require you to ma intain and clean all non-food-contact 
surfaces of equipment and tools subject to subpar t L used in covered activities during harvesting, 
packing, and holding as frequently as reasonably necessary to protect ag ainst contamination of 
covered produce.  The potential for an equipmen t or tool to come into contact with covered 
produce varies with the type a nd intended use of the equipmen t or tool.  Non-food-contact 
surfaces of tools and equipment used in cont act 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.  Howeve r, such surfaces may not require cleaning as 
frequently as those that come into direct contact with produce,  and may not require sanitizing.  
An example of such a surface is the handle of a tool used when working directly with covered 
produce, although depending on the use, such equipm ent or tool may be or consist of a food-
contact surface.  For example, a truck used to  harvest produce may not need to be thoroughly 
cleaned or sanitized; however, the flatbed of th e same truck if used to haul un-packed/loose 
produce would be considered a food-contact surface. Proposed § 112.123(e) would establis h that, if you use equipment such as pallets, forklifts, 
tractors, and vehicles such that they are inte nded to, or likely to, cont act covered produce, you do 
so in a manner that minimizes the potential for contamination of covere d produce or food-contact 
surfaces with known or reasonably foreseeable hazards.  For example, you may consider the 324 
 
appropriate route for any equipment to move i n, through, and out of production fields, and when 
there may be a need to visually inspect and cl ean such equipment to prevent contamination or 
cross-contamination of covered produce.  The pote ntial for transfer of contaminants from tractors 
to covered produce, for example, if the tractors drive through or otherwise come in contact with 
manure is also highlighted in our GAPs Guide (Ref. 10).  We seek comment on the 
appropriateness of the proposed cleaning provi sions related to equipment and tools.  
c. General requirements applicable  to instruments and controls  
Proposed § 112.124 would establish that instru ments or controls you use to measure, 
regulate, or record temperatures , hydrogen-ion concentration (pH) , sanitizer efficacy or other 
conditions, in order to control or prevent the gr owth of pathogens or ot her contamination, must 
be: (a) accurate and precise as necessary and ap propriate in keeping with their purpose; (b) 
adequately maintained; and (c ) adequate in number for thei r designated uses.  Proposed § 
112.124 is consistent with current §111.27(a)(6), and similar to requirements in current § 
110.40(f).  Accuracy addresses whethe r the recorded measurements ar e equal to the true value of 
that which is being measured, while precision addresses whether individual measurements are 
close to each other when made under the same conditions.  Both accuracy and precision are 
necessary to ensure the validity and reliability of measurements.  The appropriate degree of 
accuracy and precision, however, would need to be determined based on the nature of the 
instrument and its specific use for the covered ac tivity.  Instruments must  also be adequately 
maintained to ensure that they are functioning pr operly for their intended use.  For example, an 
in-line water oxidation-reduction potential meter that is used to determine the approximate 
sanitizer concentration in a water flume system mu st be appropriately maintained to ensure that 
there is no debris build-u p that would interfere with its pr oper operation.  In addition, you must 325 
 
have an adequate number of instruments as need ed for the designated use.  For example, if you 
are composting a small pile of manure and monitoring the temperature, one thermometer may be sufficient.  However, if you are composting larg e windrows in excess of several hundred yards in 
length, and using an automated system to monitor the internal temperatur e of the pile, you would 
need multiple thermocouples placed throughout th e pile to get a good reading of the overall 
temperature. 
d. Transport of covered produce Proposed § 112.125 would establish that equipmen t subject to subpart L that you use to 
transport covered produce during co vered activities must be: (a) ad equately clean before use in 
transporting covered produce; and (b) adequate for use in transporting covered produce.  
Transport equipment that is intende d to, or likely to, contact covere d produce that is not clean, or 
that is not adequate for the covered produce it is being used to transport, can be a source of cross-
contamination of covered produce.  Equipment us ed to transport covered produce would not be 
adequately clean if, for example, there is dirt, fi lth, organic material, particles of food, remains of 
previous shipping loads, or any other extraneous materials or c ontaminants on surfaces that are 
likely to come into contact with the produce.  Equipment used to transport covered produce 
would not be adequate if, for example, the same  equipment is used to haul live animals or 
garbage that is not completely contained, and the equipment is either not designed in a manner 
that allows cleaning and sanitizing or it is not cleaned or sanitized, before it is used to transport 
covered produce.  Proposed § 112.125 is consis tent with recommendations in FDA’s GAPs 
Guide 
(Ref. 10), the AFDO Model Code (Ref. 20), commodity-specific guidances (Ref. 85.Ref. 
94.Ref. 27), and international guidelines (Ref. 96.Ref. 96). 
e. Design and construction require ments applicable to buildings 326 
 
Proposed § 112.126 would establish re quirements applicable to the design and construction of 
buildings.  As proposed, § 112.126(a) requires that your buildings must be suitable in size, 
construction, and design to facil itate maintenance and sanitary operations for covered activities 
to reduce the potential for contamination of covered produce or food- contact surfaces with 
known or foreseeable hazards.  For buildings to be suitable in si ze, it should have enough room 
for covered activities to be c onducted without cross-contact be tween covered produce or food-
contact surfaces and building materials, non-fo od-contact surfaces, or clothing.  Proposed § 
112.126(a)(1) would establish requirements that your building provide sufficient space for 
placement of equipment and storage of materials.  This is necessary for the maintenance of 
sanitary operations and the conduct of covere d activities.  The proposed provisions in § 
112.126(a)(1) are consistent with requirements in current § 110.20(b)(1) and § 111.20.  Proposed 
§ 112.126(a)(2) would establish requirements that  your buildings must permit proper precautions 
to be taken to reduce the potential for contam ination of covered produ ce, food contact surfaces, 
or packing material with known or reasonabl y foreseeable hazards.  The potential for 
contamination must be reduced by effective desi gn, including the separa tion of operations in 
which contamination is likely to occur, by one or more of the followi ng means: location, time, 
partition, enclosed systems, or other effective mean s.  This provision provides flexibility in the 
precautions you take for your buildings and propos es separation of operations, such as by having 
sufficient space so that incompatible operations can be kept at a reasonable distance from each 
other, for example, so that spray coming off equipment being washed does not contact covered 
produce being packed.  The proposed provisions in  § 112.126(a) are similar to requirements in  
current § 110.20(b)(2) and § 111.20.    327 
 
Proposed § 112.126(a)(3) would require buildings to be  constructed in a manner such that floors, 
walls, ceilings, fixtures, ducts, and pipes can be adequately cleaned and kept in good repair, and 
that drip or condensate does not contaminate co vered produce, food-contact surfaces, or packing 
materials.  Buildings where covered activities occur must be suitably constructed to allow adequate cleaning and sanitizing in order to mini mize the presence or persistence of hazards and 
the potential for damage or contamination of co vered produce.  Buildings should be kept in good 
repair so as to prevent drip or  condensate from pipes or ceilin gs to drop onto covered produce or 
food-contact surfaces, and holes in walls of encl osed buildings from permitting pests access to 
covered produce or areas of covered activitie s.  The proposed provisions in § 112.126(a)(3) are 
consistent with requirements in  current § 110.20(b)(4) and § 111.20.   
Finally, proposed § 112.126(b) would establish requi rements that you provide adequate drainage 
in all areas where normal operations release or  discharge water or ot her liquid waste on the 
ground or floor of the building.  Standing water can attract pests and su pport the growth of 
pathogens, such as L. monocytogenes
, presenting potential for contamination of covered 
produce.  The proposed provision in § 112.126(b) is similar to requirements in current § 
110.37(b)(4) and § 111.15(f)(4). 
f. Domesticated animals in a nd around fully-enclosed buildings 
Proposed § 112.127(a) would require you to ta ke reasonable precautions to prevent 
contamination of covered produce, food-contact surfaces, and food-packing materials in fully-
enclosed buildings with known or  reasonably foreseeable hazards from domesticated animals by: 
(1) excluding domesticated animals from fully-e nclosed buildings where covered produce, food-
contact surfaces, or food-packing material is expo sed; or (2) separating domesticated animals in 
a fully-enclosed building from an area where a covered activity is c onducted on covered produce 328 
 
by location, time, or partition.  As discussed in the QAR, domesticated animals can carry 
pathogens, potentially resulting in contamination of covered produce or food contact surfaces.  
However, consistent with current § 110.35(c), we  propose to permit guard or guide dogs in some 
areas of a fully-enclosed building if the pres ence of the dogs is unlikely to result in 
contamination of produce, food-contact surfac es, or food-packing materials (proposed § 
112.127(b)).  You would need to take reasonabl e precautions to prevent contamination of 
covered produce, food-contact surf aces, and food-packing material with hazards from such dogs.  
We believe that animals such as guard or gui de dogs, when kept unde r control and where the 
activities of the animal can be contained, are un likely to result in contamination of produce, 
food-contact surfaces, or food-pack ing materials.  We seek comment on the appropriateness of 
this provision and whether proposed provision § 112.127(b) should be extended to all working 
animals.  
g. Pest control 
As discussed in the QAR, pests such as rodents,  snakes, lizards, turtles, iguanas, and birds 
are known to carry human pathogens, such as Salmonella  spp. and, if not controlled, can cause 
the contamination of covered produce, food c ontact surfaces or food-packing materials.  
Therefore, in proposed § 112.128(a), we propose to  require you to take measures reasonably 
necessary to protect covered pr oduce, food-contact surfaces, a nd food-packing materials from 
contamination by pests in buildings, including routine monitoring for pests as necessary and appropriate.  Furthermore, we propose to require you to take measures to exclude
 pests from 
fully-enclosed buildings (proposed § 112.128(b)) and to prevent  pests from becoming established 
in partially-enclosed buildings (such as by use of  screens or by monitoring for the presence of 
pests and removing them, when present) (propo sed § 112.128(c)).  We recognize that it might be 329 
 
impossible to exclude pests, such as birds, from  entering buildings that are not fully-enclosed.  
To comply with proposed § 112.128(c), you would need  to take those steps reasonably necessary 
to prevent birds or other animals from buildi ng nests in partially-enclosed buildings and, if 
possible, to find and remove any nests that become established.  Any measures or steps taken 
under these provisions would need to comply with applicable wildlife conservation regulations. 
h. Toilet and hand-washing facilities Human feces may contain pathogens in  relatively high concentrations 
(Ref. 233).  The 
most basic measure to prevent th e potential transfer of pathogens  from human feces into or onto 
covered produce and food-contact surfaces is to provi de toilet facilities th at collect and contain 
human feces.  Proposed § 112.129 would establish re quirements related to toilet facilities, 
including that you must provide personnel with adequate, readily  accessible toile t facilities, 
including facilities readily acce ssible to growing areas during harvesting activities (proposed § 
112.129(a)).  In proposed § 112.129(b), we propose to establish that toilet  facilities must be 
designed, located, and maintained  to: (1) prevent contaminat ion of covered produce, food-
contact surfaces, areas used for a covered activit y, water sources, and water distribution systems 
with human waste (proposed § 112.129(b)(1)); (2) be directly accessible for servicing, be 
serviced and kept clean on a schedule sufficient to ensure suitability of us e, and be kept supplied 
with toilet paper (proposed § 112.129(b)(2)); and (3) prov ide for the sanitary disposal of waste 
and toilet paper (proposed § 112.129(b)(3)).   Thes e provisions are intended to contribute to an 
overall sanitary measure to help protect cove red produce and areas wher e covered activities are 
conducted from contamination with pathogens.  A portable toilet faci lity that leaks or a fixed 
toilet facility that lacks prope r drainage or backflow devices would not be considered properly 
designed or maintained.  As discussed in the QAR , runoff from such a toilet facility has the 330 
 
potential to directly contamin ate covered produce, while contam ination of soil and irrigation 
water from such runoff can have longer-las ting impact.  To minimize the potential for 
contamination during events such  as flooding or high wi nds, toilet facilities  should be located 
away from water sources and wa ter distribution systems, and at a reasonable distance from 
growing and packing areas.  Sewage transport or  other servicing trucks should have clear access 
to toilet facilities to ensure proper collection and disposal of wastes.  In addition, workers are 
more likely to use toilet facilities that  are clean, well-stock ed, and in good condition (Ref. 234).  
We recognize that the growing area of a farm may spread across severa l acres of land, and 
workers or visitors may be in growing areas for an extended period of time primarily during 
harvest activities.  At times other than during harvest, we would c onsider toilet facilities to be 
readily accessible if, for example, the facility is available to wo rkers at a farm building before 
and after they work in a growing area, or at a nearby public facility  that is readily accessible to 
your workers.  However, during ha rvest activities we  consider it likely that  workers and visitors 
will spend a significant amount of time in growing areas.  We point  out that the field sanitation 
requirements prescribed by the Occupational Sa fety and Health Admi nistration (OSHA) under 
the Occupational Safety and Health Act, sp ecifically 29 CFR 1928.110, desc ribes the appropriate 
number of toilets to the number  of workers, proper handwashi ng facilities, maximum worker-to-
restroom distance, and frequency of cleaning facil ities.  Agricultural establishments subject to 
the requirements of 29 CFR 1928.110(c)(2), must provide one toilet facility for each 20 
employees or fraction thereof (except that toilet  facilities are not requ ired for employees who 
perform field work for a period of three hours or  less (including transportation time to and from 
the field) during the day).  331 
 
As discussed in the QAR, the fecal-oral route for contamination of food with pathogens is 
well-established  and proper washing and drying of hands are fundamental practices 
demonstrated to be effective in breaking the feca l-oral route of contamination.  Therefore, in 
proposed 112.129(c), we would esta blish requirements that you provide a hand-washing station 
during growing activities that take place in a fully-enclosed building, and during covered 
harvesting, packing, or holding activiti es, that is in sufficiently clos e proximity to toilet facilities 
to make it practical for persons w ho use the toilet facility to wash  their hands.  We discuss the 
importance of hand-washing in presenting the pr oposed requirements for hygienic practices in 
section V.D. of this document.   
The provisions in proposed § 112.129 are consiste nt with recommendations in our GAPs 
Guide (Ref. 10), the AFDO Model Code (Ref. 20), commodity-specific guidances (Ref. 85.Ref. 
94.Ref. 194), and international guidelines (Ref. 96.Ref. 96).  These provisions are also similar to 
requirements in current § 110.37(d) and § 111.15.  
With respect to hand-washing facilities, we  propose to require you to provide personnel 
with adequate, readily accessibl e hand-washing facilities during growing activities that take 
place in a fully-enclosed building, and during cove red harvest, packing, or holding activities 
(proposed § 112.130(a)).  In addition, in  proposed § 112.130(b), we would establish 
requirements that your hand-washing facilities must  be furnished with: so ap (or other effective 
surfactant) (proposed § 112.130(b) (1)); running water that satis fies the requirements of § 
112.44(a) for water used to wash hands (propos ed § 112.130(b)(2)); and adequate drying devices 
(such as single service towels , clean cloth towels or sanita ry towel service) (proposed § 
112.130(b)(3)).  As discussed in the QAR, hand-wash ing is a key control measure in preventing 
the spread of pathogens from ill or infected  workers to covered produce and food-contact 332 
 
surfaces.  Workers often touch produce with their bare hands.  Hand-washing, when done 
effectively, can significantly reduce the number of  resident bacteria on the hands of a worker 
who may not be aware of being ill or infected, as  well as transient microbial pathogens that get 
onto hands through contact with the environment or other ill workers.  Th e effectiveness of hand-
washing is determined by multiple factors, includi ng whether or not soap is used, the quality of 
water used, the duration of scr ubbing and rinsing, and whether and how hands are dried.  The 
frequency of hand-washing, as well as the efficac y of a single hand-washing event, may also be 
important factors in the spread of microbial  pathogens by ill or contaminated workers (Ref. 107). 
Proposed subpart 112.130(c) would establis h requirements that you provide for 
appropriate disposal of waste (for example, waste water an d used single-service towels) 
associated with a hand-washing facility and take  appropriate measures to prevent waste water 
from a hand-washing facility from contaminating covered produce, food-contact surfaces, areas used for a covered activity, agri cultural water sources, and agricultural water distribution systems 
with known or reasonably foreseeable hazards.  A hand-washing facility produces waste that can 
lead to contamination, and such waste needs to  be controlled. For example, if the sink of a 
portable hand-washing station in field actively being harvested doe s not have a catch-basin or 
tank, but instead is open the gr ound, the waste-water from the sink can contaminate the soil.  
Finally, in proposed § 112.130(d), we woul d establish that you may not use hand 
antiseptic/sanitizer as a substitute for soap and wa ter.  As discussed in the QAR, hand sanitizers 
have not been found to be effective substitutes for washing hands with soap and water, because the presence of dirt, grease, or soil reduces thei r effectiveness in eliminating bacteria.  However, 
we are not proposing to prohibit the use of saniti zers as they may be effective as an additional 333 
 
measure in reducing the number of  bacteria on hands after proper  washing with soap and water 
followed by drying  
The hand-washing provisions in pr oposed § 112.130 are consistent with 
recommendations in our GAPs Guide (Ref. 10), the AFDO Model Code (Ref. 20), commodity-
specific guidances (Ref. 85.Ref. 94.Ref. 194), and international guidelines  (Ref. 96).  They are 
also similar to the requirements in  current § 110.37(e) and §111.15(i).  
i. Disposal of sewage, trash, litter, and other waste As discussed in the QAR, human feces ma y contain pathogens in relatively high 
concentrations and, therefore, sewage must be pr operly disposed and sewage and septic systems 
must be maintained to minimize the potential for failure, leakage, or spills (and any leakage or 
spill appropriately managed) to prevent contamination of covered produce.  Events such as flooding or earthquakes also  have the potential to damage sewa ge and septic systems and impair 
their function and, therefore, it would be appropr iate to assess your sewa ge systems for damage 
or other failures, following such events.  Pr oposed § 112.131 would establish requirements that 
apply to the control and disposal of sewage, including that you mu st dispose of sewage into an 
adequate sewage or septic system or thr ough other adequate means (proposed § 112.131(a)), 
which is consistent with current § 110.37(c)  and § 111.15(g); you must maintain sewage and 
septic systems in a manner that prevents contamination of covered produce, food-contact 
surfaces, areas used for a covered activity, agri cultural water sources, and agricultural water 
distribution systems with known or reasonably foreseeable hazards (proposed § 112.131(b)); you 
must manage and dispose of leakages or spi lls of human waste in a manner that prevents 
contamination of covered produce, and prevents  or minimizes contamination of food-contact 
surfaces, areas used for a covered activity, agri cultural water sources, or agricultural water 334 
 
distribution systems (proposed § 112.131(c)); and that after a si gnificant event (such as flooding 
or an earthquake) that could negatively imp act a sewage or septic system, you must take 
appropriate steps to ensure that sewage and septic systems conti nue to operate in a manner that 
does not contaminate covered produce, food-contact  surfaces, areas used for a covered activity, 
agricultural water source s, or agricultural water distribu tion systems (proposed § 112.131(d)).  
These provisions are consistent with  recommendations in our GAPs Guide (Ref. 10), commodity-
specific guidances (Ref. 44.Ref. 46), and the AFDO Model Code (Ref. 20). 
Proposed subpart 112.132 would establish requi rements that apply to the control and 
disposal of trash, litter, and other waste in areas used for covered activities.  Proposed § 
112.132(a) would establish requiremen ts that you convey, store, a nd dispose of trash, litter and 
waste to: (1) Minimize the potential for trash, litter, or waste to at tract or harbor pests (proposed 
§ 112.132(a)(1)); and (2) Protect against contamination of co vered produce, food-contact 
surfaces, areas used for a covered activity, agri cultural water sources, and agricultural water 
distribution systems with known or reasonably foreseeable hazards (proposed § 112.132(a)(2)).  
In addition, we propose to require that you adequa tely operate systems for waste treatment and 
disposal so that they do not constitute a poten tial source of contaminatio n in areas used for a 
covered activity (proposed § 112.132(b)).  The provisions proposed in § 112.132 are consistent 
with requirements in current §§ 111.15(a) and (g ) and similar to requirements in current § 
110.37(f). These provisions are also consistent w ith recommendations for packing areas in our 
GAPs Guide (Ref. 10), and commodity-specific guidance (Ref. 46). 
j. Plumbing Proposed § 112.133 would establish that plumbi ng must be of an adequate size and 
design and be adequately insta lled and maintained to (1) dist ribute water under pressure as 335 
 
needed, in sufficient quantities, in all areas wh ere used for covered activities, for sanitary 
operations, or for hand-washing and toilet facil ities (proposed § 112.133(a));  (2) properly convey 
sewage and liquid disposable waste (proposed  § 112.133(b)); (3) avoid being a source of 
contamination to covered produce, food-contact su rfaces, areas used for a covered activity, or 
agricultural water source s (proposed § 112.133(c)); and (4) not allow backflow from, or cross 
connection between, piping systems that discharg e waste water or sewage and piping systems 
that carry water used for a covered activity, for sanitary operations, or for use in hand-washing 
facilities (proposed § 112.133(d)).  An example of  a problem that may result from inadequate 
plumbing is improper drainage of refrigeration drip  pans. If drip pans do not drain properly, they 
may drip onto covered produce or allow moisture to accumulate providing an environment that 
can support the establishmen t of and growth of L.  monocytogenes .  Proposed § 112.133 is 
intended to ensure that your plumbing and water distribution systems do not adversely affect the 
water you use in covered activitie s on covered produce.  If th e plumbing and water distribution 
systems are not adequately inst alled and maintained, they ma y contaminate your water supply 
and, in turn, contaminate your covered produce through direct contact (such as when you use 
water in irrigation or harvest activities), or through indirect contact  (such as when the 
contaminated water is used to wash a food-contac t surface).  Such cross- contamination of clean 
water and waste water has been implicated in outbreak investigations (Ref. 235).  It would also be 
important to prevent contamination of water th at must meet the requi rements under subpart E by 
water that does not meet the relevant requirement s.  For example, water used for irrigation of 
covered produce other than sprouts using a direct  water application method would need to meet 
the requirements of §§ 112.41 and 112.44(c) or (d), but would not necessarily meet the requirements of § 112.44(a) (see section V.E. of th is document).  These provisions are consistent 336 
 
with the requirements in current §§ 110.37(b) and 111.15(f), and with the recommendations in 
our GAPs Guide (Ref. 10), the AFDO Model Code (Ref. 20), and commodity-specific guidances 
(Ref. 46.Ref. 44). 
k. Control of animal excreta and li tter from domesticated animals 
In proposed 112.134(a), we would require that, if you have do mesticated animals, to 
prevent contamination of covered produce, f ood-contact surfaces, areas  used for a covered 
activity, agricultural water sources, or agricultural  water distribution systems with animal waste, 
you must: (1) adequately c ontrol their excreta and lit ter, and (2) maintain a system for control of 
animal excreta and litter.  For example, you w ould comply with this provision by not locating 
manure piles adjacent to packing sheds in which covered produce is exposed.  As discussed in 
the QAR, pathogens inhabit the gut of a variety of warm-blooded animal species and are often 
shed in feces in high numbers.  If not effectiv ely controlled, such pathoge ns may persist in the 
environment for long periods of time (see the QAR) and may pose a threat to water quality from 
runoff and leaching (Ref. 236.Ref. 169), creating multiple opportunities for these pathogens to 
contaminate produce or food contact surfaces.   
l. Record keeping Proposed § 112.140(a) would make clear that records required  under this subpart L must 
be established and kept in accordance with the re quirements of subpart O of this part.  Records 
required to be established and kept under this subpart L include documentation of the date and 
method of cleaning and sanitizing of the equipm ent you use in growing operations for sprouts 
(proposed § 112.140(b)(1)) and in co vered harvesting, packing, or hol ding activities (proposed § 
112.140(b)(2)).  These documentation requirements ar e intended to enable us to verify and you 
to ensure that requirements of this subpart are met. 337 
 
 
M. Subpart M – Standards Directed to Sprouts  Proposed subpart M would establish science- based minimal standards for the growing, 
harvesting, packing and holding of sprouts that are reasonably nece ssary to minimize the risk of 
known or reasonably foreseeable hazards that ar e associated with serious adverse health 
consequences or death.  As noted  in section I of this document,  sprouts have been frequently 
associated with foodborne illness outbreaks 
(Ref. 3).  As a result, we issued our first commodity-
specific guidance for sprouts.  Likewise, the Codex Alimentarius Commission supplemented its 
Codex Fresh Fruits and Vegetabl es Code with a Sprout Annex (Ref. 50).  
Sprouts present a special concern with resp ect to human pathogens than other covered 
produce because of the warm, moist, and nutrient-ri ch conditions required to produce sprouts, the 
same conditions that are also ideal for th e proliferation of pa thogens if present (Ref. 208.Ref. 16).  
Therefore, we believe it is neces sary to incorporate this additional subpart establishing standards 
specific to sprouts. The provisi ons of proposed subpart M are c onsistent with recommendations 
in FDA’s Sprout Guides (Ref. 14.Ref. 15), industry guidance (Ref. 237), and international 
regulations and guidelines (Ref. 38.Ref. 191.Ref. 192.Ref. 193).  
We are also seeking comment on whet her, or to what extent, the measures in this subpart should 
be applied to soil-grown sprouts. The NACMCF Sprout White paper and our Sprout Guides do 
not distinguish soil-grown sprouts and hydroponic sprouts (Ref. 14.Ref. 15.Ref. 16).  However, 
we are not aware of any outbreaks associated with sprouts grown in soil or media, which could 
be because of the lower percentage of sprouts grow n in that manner, the nature of the species of 
sprouts grown in that manner, or a differen ce in likelihood of contamination posed by that 
method and hydroponics.  This could be the case b ecause of the relative ease of transfer of 338 
 
pathogens between sprouts in a water environm ent and, possibly, a greater amplification of 
pathogens during hydroponic sprout  production compared to the more stressful environment for 
pathogen growth posed by exposure to air and su nlight when seeds are grown under conditions 
more typical of a natural setti ng (soil and media methods).  On the other hand, we expect that 
seeds or beans would be a potential vehicle of  contamination, regardless of sprouting method 
employed.  Seeds or beans (in the form of seed leaves or cotyledons) could be part of the food 
consumed, regardless of the method used for sprou ting.  In addition, flats of soil or media grown 
sprouts may be placed on a growing rack, simila r to hydroponic sprouts grown in clamshells (as 
opposed to large bins for bean sprouts or rota ting drums used to star t green sprouts), with 
overhead sprout irrigation water, providing an oppor tunity for pathogens, if present, to be spread 
within a flat of sprouts and to other flats on racks below. Altern atively, flats may be placed side-
by-side in a growing area such  as a greenhouse, where the like lihood of pathogen spread would 
presumably be lower than when a growing rack is used.  
Finally, as discussed in section IV of this document, while we recommend that farms conduct an 
operational assessment and develop a food safety plan, at this time, we are not proposing to 
require them to do so.  We request comment on whet her, in a final rule, a food safety plan and/or 
an operational assessment should be required for farms conducting covered ac tivities related to 
sprouts, either in addition to or in place of the standards proposed in this subpart.  We also 
request comment on whether a wri tten plan similar to the type required under section 418 of the 
FD&C Act would be more appropriate for farms c onducting covered activities  related to sprouts. 
1.  Comments Relevant to  the Proposed Provisions 
We received very few comments related specifically to sprouts.  Those that were submitted were 
generally supportive of our efforts to create policies to prevent il lness and produce safer sprouts, 339 
 
citing the need for addressing residual agricult ural chemicals and microbial contamination of 
seed, seed disinfection treatments, worker he alth and hygiene, and sanitation.  One comment 
hoped that we understood the realit ies currently facing the sprout industry worldwide, and would 
take actions to ensure truly practical measures that would be accepted by the sprout industry, 
questioning, for example, the need for extensive record keeping or mon itoring sprout facilities 
for Listeria . This comment maintained that we shoul d consider current production methods and 
consumption practices in estab lishing standards for sprouts. 
As discussed further in section V.M.3. of this document, our proposed rule carefully considers 
the various conditions under which sprouts are grown and consumed.  The proposal provides 
flexibility to achieve the goal of  minimizing the risk of known or reasonably foreseeable hazards 
that are associated with serious adverse health consequences or death.  We consider that the 
proposed requirements for the growing, harvesting, p acking and holding of sprouts, as well as for 
record keeping, are all practical  and necessary to protect public  health.  With respect to 
consideration of the method of growth, as disc ussed above, we are seeking comment on whether 
soil-grown sprouts are subject to the same risk factors as hydroponi c sprouts and to whether, or 
to what extent, the measures in this  subpart should be applied to them. 
One comment recommended that bean sprouts be  subjected to less stringent requirements 
compared to others, e.g., green sprouts, because bean sprouts are rarely consumed raw (less than 
1% according to their estimates). This comment suggested that seed disinfection treatments 
might not be necessary (or argued for more di sinfection method choices) for bean sprouts.  
Our 1999 Sprout Guides apply to all sprouted seeds and beans (Ref. 14.Ref. 15) and we are 
proposing in subpart M to cover all sprouts, incl uding bean sprouts.  Our earliest efforts to 
promote sprout safety, including consumer adviso ries, focused primarily on green sprouts, such 340 
 
as alfalfa and clover sprouts, where we were seeing sprout outbreaks and because we assumed 
bean sprouts were most often cooked before consumption (Ref. 238).  However, in 2002, we 
updated our consumer advisories to  include advice on the risks asso ciated with eating all types of 
sprouts, including raw and lightly cooked bean sp routs based on four foo dborne illness outbreaks 
associated with mung bean sprouts between 2000 and 2002 (Ref. 239).  As noted in section 
V.A.2.a of this document, we analyzed c onsumption of selected produce commodities to 
determine those that are rarely consumed raw.  We included sprouts (alfalfa and mung bean) in 
our analysis, and based on data available from  the NHANES, alfalfa and mung bean sprouts do 
not meet our criteria for rarely consumed raw commodities (Ref. 79).  
2. Proposed Requirements 
Proposed § 112.141 would establish meas ures directed to seeds or beans used to grow sprouts.  
Seeds and beans used for sprouting are believed to be the vehicle for contamination in most E.  
coli O157:H7 and Salmonella  foodborne illness outbreaks associated with sprouts (Ref. 3.Ref. 
16). Proposed § 112.141 is consistent with our Sp rout Guide and other public and private 
programs (Ref. 50.Ref. 240).   
Proposed § 112.141(a) would require th at, if you grow seeds or bean s for use to grow sprouts, 
you must take measures reasonably necessary to prevent the introduction of known or reasonably 
foreseeable hazards into or onto seeds or beans that you will use for sprouting.  These measures 
would need to be taken during growing, harvesti ng, packing, and holding of seeds and beans, 
which include such activities as cleaning, conditioning, and blending.  
Various crops may be grown to produce seed s and beans for sprouting with different 
production practices, growing seas ons, conditions, and crop needs.  Some of these plants set 
seeds or beans without interventi on from growers, while others (such as alfalfa) may require 341 
 
steps, such as being cut-back, to  encourage seed set.  Harvesting, packing, and holding may also 
vary by seed type and by the conditions needed to  maintain seed quality, such as germination.  
Because of the diversity of practices, proce sses, and procedures, the controls reasonably 
necessary to prevent the introdu ction of known or reasonably fo reseeable hazards into or onto 
seeds or beans that you use for sprouting may var y.  Therefore, we are not proposing to prescribe 
specific measures that are r easonably necessary to preven t the introduction of known or 
reasonably foreseeable hazards into or onto s eeds or beans. However, you may refer to our 
recommendations in relevant guidances (Ref. 14.Ref. 10).  
It is well-established that sprouts can become contaminated through the use of 
contaminated seeds for sprouting.  Therefore, we considered proposing a supplier approval and 
verification program for seeds and beans received  by sprouters for sprouting purposes.  Such a 
program would provide assurance th at seeds or beans received from a third party for use to grow 
sprouts are grown, harvested, stored, and handl ed using measures reasonably necessary to 
prevent the introduction of known or  reasonably foreseeable hazards into or onto seeds or beans 
used for sprouting.   
However, a supplier approval and verification program may not be pr actical or effective 
for seeds and beans received by sprouters for spr outing purposes.  For example, for most crops, 
only a small percentage of the harvested seeds or beans goes to sprout production (Ref. 16.Ref. 
241).  Several distributors sell s eeds and beans primarily for agricultural use with little or no 
sales for sprouting (Ref. 16).  Seeds and beans have a relative ly long shelf-life, sometimes being 
stored for a year or longer, a nd they often pass through a number of business entities before their 
final sale.  Therefore, the ultimate end use of seeds and beans will likely not be known by many growers, handlers, or distributors 
(Ref. 16.Ref. 196.Ref. 192.Ref. 197).  We are also not aware of 342 
 
any regulatory standards that in clude a supplier approval and veri fication program for seeds and 
beans received by sprouters for sprouting purposes .  For example, Food Standards Australia New 
Zealand (FSANZ) considered but did not require such a program (Ref. 242).  We ask for 
comment on this approach and whether there are a dditional practical steps or practices that can 
be taken to ensure the safety of seeds and b eans used for sprout production.  Specifically, we 
request comments on whether a supplier approval and verification program for seeds and beans 
intended for sprout production is practical and effective. 
We also considered whether to propose a requirement that you test incoming seeds and 
beans, and rejected this appro ach.  Although epidemiological inve stigations ofte n identify seeds 
and beans as the most likely source of contamina tion, contamination may be at very low levels (4 
CFU/kg seed) (Ref. 16) and laboratory analyses have frequen tly been unable to isolate pathogens 
from implicated seeds or beans (Ref. 243).  In a recent EFSA publica tion, the authors concluded 
that a 2-class sampling plan “absence in 25g” , n=5; c=0, as specified in EC Regulation 
2073/2005 for sprouted seeds, will not give suffici ent confidence to demons trate the absence of a 
target pathogen at these low levels in seeds.  To increase the probability of rejection of a positive 
lot, the authors estimated that it would be necessary to analyze kilogram quantities of the sample 
(Ref. 244).  Guidances from Canadian and Irish author ities include recommendations that seeds 
and beans be tested by the distributor, and that the sprouter obtain a Certificate of Analysis 
(CoA) for the seeds and beans (Ref. 240.Ref. 245), but recognize the limitati ons of testing seeds.   
While a negative test result is not a guarantee of the absence of pathogens, a positive test 
result would facilitate detection of contaminated  seeds and beans for destroying or diverting to 
non-food use.  Thus, we would encourage seed suppliers and sprouters to test seed using 
statistically valid sampling and te sting protocols. However, we te ntatively conclude that testing 343 
 
seeds and beans is not sufficiently reliable to include as a measure necessary to prevent the 
introduction of known or reasonably foreseeable hazards.  Instead, we propose to focus on seed 
treatment (proposed § 112.142) and testing spent irrigation water from each production batch of 
sprouts (or testing each production batch of sprout s at the in-process stage when testing spent 
irrigation water is not pract icable) (proposed § 112.143). 
When seeds or beans are used to produce spr outs, they are “food,” as defined in section 
201(f) of the FD&C Act (Ref. 95).  The definition of “food” in proposed § 112.3 is consistent 
with this interpretation. When you grow, harvest,  pack, and store seeds and beans for sprouting 
at your operation, you know the end use of th e seeds and beans, and proposed § 112.141(a) 
would require that you exercise control over that input into your sprout production.  On the other 
hand, growers of seeds and beans may be unaware as to whether their crop will be used for sprout production.  We seek comment on any provis ions that would be ef fective in reducing the 
risk posed by contaminated seeds or beans in such cases, without also imposing an undue burden 
on the agricultural sector that produces seed used  primarily for purposes of growing food or feed 
crops and not intended for use as food for human consumption as sprouts.  
Proposed § 112.141(b) through (c) would establish additional requirements  to ensure that 
seeds and beans do not serve as a vehicle for in troducing contamination in sprouts.  Proposed § 
112.141(b) would require that if you know or have reason to believe that a lot of seeds or beans 
has been associated with foodborne illness, you must  not use that lot of seeds or beans to produce 
sprouts.  Contamination of seeds and beans is  generally at a low le vel and not distributed 
homogeneously throughout a seed lot.  Thus, a se ed lot may be in distribution for some time and 
in use by multiple sprout farms before it is known or suspected to be contaminated.  As discussed in the QAR, we are aware of outbreaks associated with multiple sprout farms using the same lot 344 
 
of seed.  In addition, pathogens, such as Salmonella  and E. coli  O157:H7, can survive for an 
extended period of time on seeds and beans, as ev idenced by outbreaks linked to seed that is a 
year or two old, so setting asid e a potentially contaminated seed lot for later use does not reduce 
the likelihood of producing contaminated sp routs from that lot of seeds or beans (Ref. 16.Ref. 
243). For these reasons, we have tentatively c oncluded that, once you know or have reason to 
believe that a lot of seeds or beans is contaminated, through micr obial testing or implication as 
the vehicle in an outbreak, there is reason to believe that other parts of that lot may also be 
contaminated, you must not use that lot of seeds or beans to produce sp routs.   This is consistent 
with existing guidan ces and standards (Ref. 16.Ref. 18.Ref. 192.Ref. 193). 
Proposed § 112.141(c) would requi re that you visually examine seeds and beans, and 
packaging used to ship seeds or beans, for signs of potential contam ination with known or 
reasonably foreseeable hazards.  Visual examination of seeds and beans for sprouting, and the packaging used to ship them, provides an opport unity to see signs of potential contamination, 
such as rodent or bird feces or urine, wh ich may introduce pathogens into or onto sprouts 
(Ref. 
241.Ref. 246).  Feces from rodents and birds are known to carry pathogens (Ref. 247).  This 
proposed provision is consistent with recent FDA and international guidance (Ref. 38.Ref. 
18.Ref. 192.Ref. 193).  
Proposed § 112.142 would establish measures y ou must take for growing, harvesting, 
packing, and holding sprouts.  Specifically, pr oposed § 112.142(a) would re quire that you grow, 
harvest, pack, and hold sprouts in a fully -enclosed building.  Pr oposed § 112.142(b) would 
require that any food-contact su rfaces you use to grow, harvest, pack, or hold sprouts must be 
sanitized after cleaning and before contact with sprouts or  seeds or beans used to grow sprouts.  
As discussed in the QAR, although the source of contamination in outbreaks associated with 345 
 
sprouts has most often been incoming seeds or beans, pathogens can also be introduced during 
sprout growing, harvesting, packing, and holding.  .   
Therefore, we are proposing these additi onal requirements for sprout farms (i.e., 
conducting operations in a fully enclosed build ing, sanitizing food-contact surfaces after 
cleaning) because we have tenta tively concluded that the sprou ting process represents a unique 
bacterial amplification step that requires a hi gher level of care co mpared to the growing, 
harvesting, packing, and holding of other covere d produce..  This proposed approach, a higher 
level of care compared to produce growing, harvesting, packing and holding generally, is 
consistent with Codex guidelines (Ref. 50). 
Proposed § 112.142(c) would require you to treat seeds or beans th at will be used to grow 
sprouts using a scien tifically valid method immediately before sprouting to reduce 
microorganisms of public health significance.  Co nsistent with our previous discussion of the 
term “scientifically valid” with respect to test ing in the proposed rule to establish Current Good 
Manufacturing Practice requirements for dietary ingredients and dietary supplements (68 FR 
12157 at 12198), we use the term “scientifically valid ” to mean using an approach that is based 
on scientific information, data, or results publ ished in, for example, scientific journals, 
references, text books, or proprie tary research.  Methods used for reducing microorganisms of 
public health significance in seeds or beans for spr outing must be scientifically valid if they are 
to provide assurance that they are effective.  
Prior treatment conducted by a gr ower, handler, or di stributor of seeds or beans, does not 
eliminate your responsib ility to treat seeds or beans imme diately before sprouting, at your 
covered farm.  This proposed requirement is consistent with NACMCF recommendations and 
our Sprout Guide (Ref. 16.Ref. 14) and international guidance  (Ref. 193.Ref. 191.Ref. 38).  346 
 
Specifically, NACMCF recommends th at seed treatments that deliv er less than a 5-log pathogen 
reduction be coupled with a microbial testing program.  We did not cite any specific log 
reduction in our Sprout Guide as “adequate to reduce pathogens.”  At that time, few if any seed 
treatments were thought to be capable of consis tently delivering a 5-log pathogen reduction.   
A number of treatments have been shown to reduce levels of, but not eliminate, 
pathogenic bacteria present on seeds. Such tr eatments are likely to  reduce the level of 
contamination if present and, in turn, decrease th e risk for foodborne disease with sprouted seeds 
(Ref. 16).  We cited in the Sprout Guide a 20,000 ppm calcium hypochlorite treatment as an 
example of a treatment that ha s been shown to be effective for the reduction of pathogens on 
seed.  Scientific literature i ndicates that the 20,000 ppm Ca(OCl) 2 treatment, widely adopted by 
sprouters who treat seed prior to sprouting, produces a 2.5 log reduction, with a range of 1.0 – 
6.5 log reduction (Ref. 192.Ref. 201).  Other chemical and physical seed disinfection treatments, 
alone and in combination, have been evaluate d for efficacy but there is a high degree of 
variability in research results based on a numbe r of factors (e.g., seed type, whether seed was 
naturally or artificially contaminated, level of initial contamination).  In their evaluation of the current state of microbiological safety  of seeds and sprouts, Fett et al 
(Ref. 243) present a 
comparison of the efficacy of select aqueous ch emical disinfection trea tments with Ca(OCl) 2 for 
sanitizing alfalfa seed from the literature.  Canada recommends a lower level of calcium 
hypochlorite, 2,000 ppm (Ref. 245). 
We acknowledge that several outbreaks have brought into question the effectiveness of 
seed disinfection treatments. For example, an outbreak of Salmonella  kottbus  in alfalfa sprouts 
was linked to seed that underwent a chlorine  sanitization step, alt hough records indicate the 
concentration of chlorine was probabl y lower than the recommended 20,000 ppm (Ref. 248). 347 
 
Conversely, in 1999, an outbreak of Salmonella enterica  serotype Mbandaka occurred in Oregon, 
Washington, Idaho, and Californi a. Based on epidemiologic and pulsed-field gel electrophoresis 
evidence from 87 confirmed cases, the outbreak wa s linked to contaminated alfalfa seeds grown 
in California’s Imperial Valley. Trace-back and trace-forward inve stigations identified a single 
lot of seeds used by five sprout growers during the outbreak period. Cases of salmonellosis were 
linked with two sprout growers who had not em ployed chemical disinfection; no cases were 
linked to the three sprout grow ers who used seed disinfection (Ref. 249). In another outbreak of 
Salmonella  typhimurium  in clover sprouts linked to seed sold to multiple sprout operations, 
sprouters who had treated the seeds in 20,000 ppm ch lorine had fewer cases attributed to their 
sprouts compared to those that did not (Ref. 250). This is consistent with modeling work by 
Montville and Schaffner, indicati ng that, while disinfection of s eeds prior to sprouting did not 
guarantee pathogen free sprouts, disinfection reduced  the percentage of contaminated batches. 
Seed disinfection was most effective when contam ination was sporadic and at low levels; at a 
low prevalence (1 out of 10,000 25-g samples are positive), as would normally be expected, the 
percentage of contaminated batches was reduced from 13.7 to 0.1%. Where the initial 
contamination was high and uniform, the proporti on of contaminated batches was reduced only 
from 100 to 87.7% (Ref. 251).   
For these reasons we continue to believe that seed disinfection treatments are valuable as 
one of several measures necessary to ensure the safety of sprouts.  We ask for comment on this 
approach.  
Proposed § 112.143 would establish requirements for testing pr ocedures you apply to the 
growing, harvesting, packing, and holding of sp routs.  Specifically, proposed § 112.143(a) would 
require that you test the grow ing, harvesting, packing, and holding environment for Listeria  spp. 348 
 
or L. monocytogenes  (Lm) in accordance with the requirements of § 112.144.  The proposed 
testing requirement in § 112.143(a) is in response  to emerging concerns about positive sample 
findings and multiple recalls asso ciated with L. monocytogenes  in sprouts (Ref. 17.Ref. 252).  
Between 2002 and 2010, there have been 10 recalls  involving multiple sprout types due to 
potential or confirmed contam ination with L. monocytogenes   (Ref. 253).  In one of these recalls, 
the strain found in sprouts matched the strain isolat ed from 20 confirmed cases of listeriosis in 6 
States and positive sample findings from an environmental investigation at the sprouting operation 
(Ref. 252). 
Contamination from L. monocytogenes  from the environment is common (Ref. 207) and, 
thus, targeted preventive contro ls to minimize L. monocytogenes  in RTE foods are warranted.  
While appropriate sanitation measures can minimi ze the presence of environmental pathogens in 
a sprouting operation, we tentativ ely conclude that environmenta l monitoring is still necessary 
for sprouting operations as an added safety measure.  Such monitoring can be conducted by 
testing for the specific pathogenic microorganism or by testing for an “indicator organism,” 
which can indicate conditions in which the enviro nmental pathogen may be present.  Typically, a 
firm that finds an indicator organism duri ng environmental monitoring conducts microbial 
testing of surrounding surfaces and areas to determ ine the potential source of the contamination, 
cleans and sanitizes the contaminated surfaces  and areas, and conducts additional microbial 
testing to determine whether the contamination has been eliminated.  Further steps may be 
necessary if the indicator organism is found on rete st.  Tests for the indicator organism Listeria 
spp. detect multiple species of Listeria , including the pathogen L. monocytogenes . For example, 
USDA’s FSIS regulations a nd guidelines use Listeria  spp. as an appropriate  indicator organism 
for L. monocytogenes  in for RTE meat or poultry pr oducts exposed to the processing 349 
 
environment after cooking to prevent product adulteration by L. monocytogenes   (Ref. 254).  
FDA’s current thinking is that Listeria  spp. is an appropriate i ndicator organism for L. 
monocytogenes , because tests for Listeria  spp. will detect multiple species of Listeria , including 
L. monocytogenes , and because the available information supports a conclusion that modern 
sanitation programs, which incorporate environmental monitoring for Listeria  spp., have public 
health benefits.  The taking of actions based on th e presence of an appropria te indicator organism 
is protective of public health, sin ce there will be times when steps are taken in the absence of the 
pathogen.  Therefore, we tenta tively conclude that testing th e growing, harvesting, packing and 
holding environment for Listeria  spp. or L. monocytogenes  is a necessary measure to ensure the 
safety of sprouts.  
Proposed § 112.143(b) would require that you either: (1) test sp ent sprout irrigation water 
from each production batch of sprouts for E. coli  O157:H7 and Salmonella  spp. in accordance 
with the requirements of § 112.146; or (2) if testing spent sprout ir rigation water is not 
practicable (for example, for soil-grown sprouts) , that you test each production batch of sprouts 
at the in-process stage (i.e., while sp routs are still growing) for E. coli  O157:H7 and Salmonella  
spp. in accordance with the requirements of § 112.146.  A production batch for which either of 
these pathogens is detected in the spent irriga tion water for the sprouts would be considered 
adulterated under Section 402(a)(4) of the FD&C Act, in that  it has been prepared, packed, or 
held under insanitary conditions whereby it may have been rendered injurious to health.  A 
production batch for which either of these pat hogens is detected in the sprouts would be 
considered adulterated under Sect ions 402(a)(1) of the FD&C Act, in that the sprouts contain a 
poisonous or deleterious substance which may rende r it injurious to hea lth.  Therefore, we 
tentatively conclude that microbiological tes ting of spent irrigation water from each production 350 
 
lot (or of each production batch of  sprouts) is necessary to provi de reasonable assurances that 
sprouts are not adulterated under Section 402 of  the FD&C Act.  The proposed testing 
requirement in § 112.143(b) to test spent sprout  irrigation water (or sprouts) for Salmonella  and 
E. coli  O157:H7 would codify current recommendations  in our Sprout Guides and is consistent 
with existing international guidelines and regulations (Ref. 38.Ref. 191.Ref. 193).   
We are proposing these testing requirement s in § 112.143(b) in addition to the proposed 
treatment requirements in § 112.142(c) because pathoge ns that are merely injured, but not killed, 
by seed treatment could potentially grow out agai n when subjected to enrichment conditions, as 
experienced during sprouting (Ref. 16.Ref. 74).  Because seed disinfecti on treatments can reduce, 
but may not eliminate, pathogens on seed, we ar e proposing to require microbiological testing.  
Spent irrigation water that has flowed over and through sprouts is  a good indicator of the types 
and quantities of microorganisms in the sprouts themselves (differing by only 1 log or less from 
the level in the sprouts) and the microflora in  spent irrigation water is fairly homogeneous (Ref. 
15.Ref. 198.Ref. 209). The optimal time for testing is when pathogen levels are highest 
(approximately 24 - 48 hours after th e start of sprouting), but also when it is  early enough in the 
sprouting process to obtain resu lts before product is shipped.   
We have emphasized testing irrigation water in proposed § 112.143(b) because testing 
sprouts has several significant di sadvantages compared to testing spent irrigation water. First, 
contamination of sprouts is not likely to be as  homogeneous as is th e spent irrigation water (Ref. 
243.Ref. 255).  Second, multiple sprout samples must be  taken from differen t locations in the 
drum or trays to ensure that the sample collec ted is representative of the batch. Furthermore, 
additional preparation (e.g., sele cting representative subsampl es for analyses, blending or 
stomaching) is required when testing sprouts. Ea ch additional step introduces a possibility for 351 
 
error.  Consequently, testing of spent sprout ir rigation water is generally preferred over testing 
sprouts unless production methods make it impractical  to test spent sprout  irrigation water. For 
example, spent irrigation water may not be av ailable when sprouts are grown in soil.  
We chose pathogen testing for Salmonella  spp. and E. coli  O157:H7 because these 
pathogens are the two most common agents in  sprout-associated outbreaks in the U.S. (Ref. 3).  
Recently, EFSA concluded that there are currently  no indicator organisms that can effectively 
substitute for the testing of  pathogens in seeds, sprout ed seeds or ir rigation water (Ref. 244). We 
tentatively concur with  this conclusion.   
In developing our Sprout Guides in 1999 and in deliberations for this proposed rule, we 
also considered whether to include testing sp ent sprout irrigation wa ter for L. monocytogenes , in 
addition to testing it for Salmonella  spp. and E. coli  O157:H7. However, we tentatively 
concluded that testing spent spro ut irrigation water for Listeria  has a number of potential 
challenges.  The warm, moist, nutrient-rich  conditions during sp routing encourage the 
proliferation of Salmonella  and E. coli  O157:H7 and this prolifera tion increases the probability 
of their detection, if present.  In contrast, Listeria  may be a poor competitor at the warmer 
temperatures and against the high level of native mi croflora present during th e sprouting process.  
In addition, Listeria  is ubiquitous.  We woul d expect frequent positiv es using rapid tests for 
Listeria  spp., which would not necessarily mean pat hogens were present.  Such testing would 
need to be followed by confirmatory testing to determine whether or not L. monocytogenes  was 
present in order to determine a ppropriate actions with respect to  the product.  While rapid test 
kits are now available to screen for L. monocytogenes , their use on spent sprout irrigation water 
or sprouts would need  to be validated (Ref. 14).  We tentatively conclude that environmental 352 
 
monitoring for Listeria  spp. or L. monocytogenes  is the most practical approach for control of 
this pathogen.  We request commen ts on this tentative conclusion. 
We also considered the appropriateness of proposing provisions for testing spent sprout 
irrigation water for non E. coli  O157:H7 shiga toxi n-producing E. coli  (STEC) which were 
involved in the recent large sprout associated E. coli  O104 foodborne illness outbreak in Europe 
(Ref EU OB).  The O104:H4 stra in that caused the outbreak in Europe was an unusual strain that 
none of the tests that were being used to test for enterohaemorrhagic E. coli  (EHEC) at that time 
would have picked it up.   The challenge is that  there are estimated to be 400 serotypes of E. coli  
that produces any one of the 3 Stx1 and/or 8 Stx2  subtypes and many of these are isolated from 
environmental and animal sources but have not been implicated in human illness.  Many of the STEC strains entailed te dious plating and retesting to isol ate and even longer to serotype 
(Ref. 
256).  For these reasons, we tentatively conclude that proposing to require testing spent sprout 
irrigation water for non E. coli  O157:H7 STECs would not be a prac tical approach at this time.   
We request comments on this tentative conclu sion, and on whether pathogens in addition 
to E. coli  O157:H7 and Salmonella  spp. should be included in tes ting of spent sprout irrigation 
water or in-process sprouts, either by specifi cally listing the additiona l pathogens or by set 
criteria (e.g., association with  one or more outbreaks linked to sprouts) for inclusion.  
Proposed § 112.144 would establish require ments for how you test the growing, 
harvesting, packing, and holding environment for Listeria spp. or L. monocytogenes .  
Specifically, proposed § 112.144(a) would require that you establish and implement a written 
environmental monitoring plan that is designed to find L. monocytogenes  if it is present in the 
growing, harvesting, packing or holding environment. Proposed § 112.144(b) would require that 
your written environmental monitoring plan be di rected to sampling and testing for Listeria spp. 353 
 
or L. monocytogenes .  Proposed § 112.144(c)(1) through (3) would require that your written 
environmental monitoring plan include a sampli ng plan that specifies:  What you will test 
collected samples for (i.e., Listeria  spp. or L. monocytogenes ) (proposed § 112.144(c)(1)); How 
often you will collect environmental samples, wh ich must be no less than monthly (proposed § 
112.144(c)(2)); and Sample collection sites.  The number and location of sampling sites must be 
sufficient to determine whether measures are eff ective and must include appropriate food-contact 
surfaces and non-food-contact surfa ces of equipment, and other surfaces within the growing, 
harvesting, packing, and holding environmen t (proposed § 112.144(c)(3)).  Proposed § 
112.144(d) would require you to co llect environmental samples and test them for Listeria  spp. or 
L. monocytogenes  according to the method in § 112.152.  
Proposed § 112.144(c)(1) would require that you specify whether you will be testing for 
the pathogen L. monocytogenes  or the indicator organism, Listeria  spp.  As discussed above, 
FDA’s current thinking is that Listeria  spp. may be an appropriate indicator organism for L. 
monocytogenes , because tests for Listeria  spp. will detect multiple species of Listeria , including 
L. monocytogenes . FDA expects environmental monitori ng to be conducted with sufficient 
frequency to detect the environmental pathogen or appropriate indicator organism if present. We 
tentatively conclude that mont hly sampling and testing is a minimum requirement (proposed 
§ 112.144(c)(2)).  More frequent testing may be  needed.  For example, the frequency of 
monitoring for environmental pathogens should incr ease as a result of finding the environmental 
pathogen or an indicator of the environmental pat hogen or as a result of situations that pose an 
increased likelihood of cont amination, e.g., construction (Ref. 211.Ref. 212).  The frequency of 
taking environmental samples will vary depending on existing data on the presence of the environmental pathogen of concern in the environment where foods  are exposed to the 354 
 
environment.  In the absence of information, data  should be generated to assist in determining 
the frequency of monitoring (Ref. 257).  We request comment on whether the minimum 
frequency of at least monthly for environmenta l monitoring is adequate to assess whether the 
measures taken to minimize the risk associated with L. monocytogenes  in sprouts are effective.  
We tentatively conclude that specifying the freq uency of testing in the written environmental 
monitoring plan is necessary to enable assura nce by the operator and verification by FDA that 
testing efforts are consistent with a carefully thought through effort to find the environmental 
pathogen if it is presen t in the environment. 
The purpose of environmental monitoring is to verify the implementation and 
effectiveness of sanitation measures for c ontrolling the presence of L. monocytogenes  in the 
sprout production environment.  The monito ring must be designed to find environmental 
pathogens that remain in the sp routing operation after routine cleaning and sanitizing procedures 
in order to prevent contamination of product th at could lead to illness.  To accomplish this 
purpose, there must be a scientific basis for th e locations selected for sampling, the number of 
samples taken, the frequency of sampling, th e sampling procedures used and the test 
methodology.  The sampling must be biased – i.e., th e locations to be tested must be those in 
which the environmental pathogens can enter th e environment where the food is exposed and 
those areas where harborage of the pathogen is likely (Ref. 258).   
One approach to defining sampling locations is to divide the spr outing operation into 
zones based on the likelihood of contamination of the product.  A common industry practice is to 
use four zones (Ref. 213.Ref. 212): Zone 1 consists of food-contact  surfaces; Zone 2 consists of 
non-food-contact surfaces in close proximity to food and food-contact surfaces; Zone 3 consists 
of more remote non-food-contact surfaces that are in the area used for growing, harvesting, 355 
 
packing, and holding and could lead to contaminati on of zones 1 and 2; and Zone 4 consists of 
non-food-contact surfaces, outside of the area used for growing, harvesting, packing, and holding 
from which environmental pathogens can be in troduced into the growing, harvesting, packing, 
and holding environment.  Generally the number of samples and frequency of testing is higher in 
zones 1 and 2 because of the greater likelihood of food contamination if the environmental 
pathogen is present in these zones. Informati on on appropriate locations for sampling within 
these zones can be found in the literature (Ref. 175.Ref. 212).  Operators should become familiar 
with locations in which environm ental pathogens have been found in other sprout firms and use 
this information in selecting sites to sample. 
L. monocytogenes  frequently establishes itself in a harborage site on equipment and 
grows (increases in number) there, where bot h food and moisture are available.  L. 
monocytogenes  organisms work their way out of th e harborage site during production and 
contaminate food.  Testing food- contact surfaces for Listeria  spp. is a commonly recommended 
verification measure for firms producing refrigerated RTE foods (Ref. 175.Ref. 211).   
Examples of appropriate non- food-contact surfaces that c ould be monitored include 
exteriors of equipment, equipment supports, control panels, door ha ndles, floors, drains, 
refrigeration units, ducts, overhead structures, cleaning tools, and mo tor housings.  Standing 
water in growing, harvesting, and packing areas a nd areas that have beco me wet and then have 
dried are also appropriate places to monito r. Testing non-food-contact surfaces for L. 
monocytogenes  or Listeria  spp. is a commonly recommended verification measure for firms 
producing refrigerated or frozen RTE foods (Ref. 258.Ref. 259) and can detect L. monocytogenes  
that is brought into the plant by people or objects.  Actions you th en take can prevent transferring 356 
 
the organisms to a food-contact surface (where they  can contaminate food) or from establishing a 
harborage that can serve as a source of contamination.   
Proposed § 112.145 would establish requirements for actions you must take if you detect 
Listeria  spp. or L. monocytogenes  in the growing, harvesting, packing, or holding environment, 
i.e., Conduct additional microbial testing of surfaces and areas surrounding the area where 
Listeria  spp. or L. monocytogenes  was detected to evaluate the extent of the problem, including 
the potential for Listeria  spp. or L. monocytogenes  to have become established in a niche 
(proposed § 112.145(a); Clean and sanitize the affected surfaces and surrounding areas 
(proposed § 112.145(b)); Conduct additional micr obial sampling and testing to determine 
whether the Listeria  spp. or L. monocytogenes  has been eliminated (proposed § 112.145(c)); 
Conduct finished product testing when appropr iate (proposed § 112.145(d)); and Perform any 
other actions necessary to prevent reoccu rrence of the problem (proposed § 112.145(e)). 
Testing the environment of a sprout ing operation for L. monocytogenes  (or for Listeria  spp. as an 
indicator of potential contamin ation 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 microor ganisms of public health significance (Ref. 175.Ref. 
211).  The actions we are proposing to require, including additional testing to determine the 
extent of contamination, ensuri ng contamination is eliminated a nd taking steps to prevent its 
recurrence, are consistent with  recommendations in our Listeria  Guide (Ref. 260). 
If an environmental pathogen or an appropriate  indicator organism (t he test organism) is 
detected in the environment, steps must be ta ken to eliminate the organism, including finding a 
harborage site if one exists (Ref. 175.Ref. 211)(Ref. 257).  Otherwise, the presence of the 
environmental pathogen could result in contamin ation of food-contact surfaces or food.  The 357 
 
presence of the indicator organism suggests th at conditions exist in which the environmental 
pathogen may be present and could result in c ontamination of food-cont act surfaces or food.  
Actions must be taken for every finding of an environmental pathogen or indicator organism in 
the environment to prevent contaminati on of food-contact surfaces or food.   
Sampling and microbial testing from su rfaces surrounding the area where the test 
organism was found (proposed § 112.145(a)) are n ecessary to determine whether the test 
organism is more widely distributed than on th e original surface where it was found and to help 
find the source of contamination if other s ites are involved.  Clean ing and sanitizing the 
contaminated surfaces and surrounding areas (pr oposed § 112.145(b)) are necessary to eliminate 
the test organism that was found there.  Add itional sampling and microbial testing (proposed § 
112.145(c)) are necessary to determine the efficacy  of cleaning and sanitizing.  For example, 
detection of the test organism after cleaning and sanitizing indicat es that the initial cleaning was 
not effective, and additional, more intensified cleaning and sanitizing, or  other actions may be 
needed, including dismantling equipment, scrubbing surfaces, and heat-tre ating equipment parts 
(Ref. 207).  The finding of a test organism on a food- contact surface usually represents transient 
contamination rather than a harborage site (Ref. 259).  However, finding the test organism on 
multiple surfaces in the same area, or continui ng to find the test organism after cleaning and 
sanitizing the surfaces where it was found, suggest s a harborage site for the test organism.  
Mapping the location of contamination sites, whethe r the harborage site is on equipment or in the 
environment, can help locate the source of the ha rborage site or identify additional locations to 
sample (Ref. 257).  
Proposed § 112.145 would not specify how certain  actions must be performed, such as 
the number of sites to test when the test orga nism is found in a sprouting operation, or how to 358 
 
clean and sanitize the surfaces on which the test organism was detected.  The number of sites 
appropriate for testing and the applicable clean ing and sanitizing proced ures will depend on the 
sprouting operation and the equipment.  We tenta tively conclude that, when microbial testing is 
conducted as part of steps in light of the resu lts of environmental monitoring, specifying such 
procedural requirements would not provide facili ties with sufficient flexibility to develop and 
implement aggressive and appropriate actions  to find and eliminate the source of the 
contamination in the environment. Such actions may involve investigative procedures when the 
initial measures have not been successful in el iminating the environmenta l pathogen or indicator 
organism. One example of an investigative pr ocedure is taking samples from food-contact 
surfaces and/or produce at multiple times during the day while the equipment is operating and 
producing product  (Ref. 207).   
Proposed § 112.145(d) would require that if environmental monitoring identifies the 
presence of an environmental pathogen or in dicator organism, the operator conduct finished 
product testing, when appropriate.  As discussed in section IV.I. of this document, there are 
shortcomings for microbiological testing of food for process cont rol purposes.  Testing cannot 
ensure the absence of a hazard, particularly when th e hazard is present at very low levels and is 
not uniformly distributed.  If an environmenta l pathogen is detected on a food-contact surface, 
finished product testing would be  appropriate only to confirm actual contamination or assess the 
extent of contamination, because negative find ings from product testing could not adequately 
assure that the environmental pathogen is not  present in food exposed to the food-contact 
surface.  If you detect an environmental pat hogen on a food-contact surface, the sprouting 
operation should presume that the produce is adu lterated under Section 4 02(a)(4) of the FD&C 
Act. 359 
 
Finished product testing could be appropriate if an environm ental pathogen is detected on 
a non-food-contact surface, such as on the exterior of equipment, on a floor or in a drain.  The 
potential for food to be contaminated directly from contamination in or on a non-food-contact 
surface is generally low, but transfer from non-fo od-contact surfaces to food contact surfaces can 
occur. Finished product testing can  provide useful information on the overall risk of a food when 
pathogens have been detected in the environment.  
Proposed § 112.145(e) would require that if environmental monitoring identifies the 
presence of an environmental pathogen or appr opriate indicator organism, the operator perform 
any other steps necessary to prev ent recurrence of the contaminati on.  Actions taken as a result 
of monitoring for an environmental pathogen or an indicator organism for such pathogen must 
ensure these requirements are met.  The measures for environmental monitoring specified in proposed § 112.145(a) through (d) are not all inclusiv e.  Examples of measures that may be 
necessary include reinforcing employee hygiene pract ices and traffic pattern s; repairing damaged 
floors; eliminating damp insulation, water leak s, and sources of sta nding water; replacing 
equipment parts that can become harborage si tes (e.g., hollow conveyor rollers and equipment 
framework), and repairing roof leaks 
(Ref. 180.Ref. 219). Additional information on measures for 
environmental monitoring can be found in the literature (Ref. 180.Ref. 221.Ref. 219).  Proposed 
§ 112.145 is consistent with the FSIS Listeria  Guidelines (Ref. 254).   
Proposed § 112.146 would establish requirements for how you collect and test samples of 
spent sprout irrigation water or sprouts. Sp ecifically, proposed § 112.146(a)  would require that 
you establish and implement a written sampling plan  that identifies the number and location of 
samples (of spent sprout irrigation water or sprouts) to be collect ed for each production batch of 
sprouts to ensure that the co llected samples are representati ve of the production batch when 360 
 
testing for contamination. Additionally, proposed  § 112.146(b) would require that, in accordance 
with the written sampling plan required under pa ragraph (a) of this section, you aseptically 
collect samples of spent sprout irrigation water or sprouts, and test the collected samples for E.  
coli O157:H7 and Salmonella  spp. using a method that has been  validated for its  intended use 
(testing spent sprout irrigation wate r or sprouts) to ensure that th e testing is accurate, precise, and 
sensitive in detecting these pathogens. Th is proposed provision is consistent with 
recommendations in our Sprout Testing Guide,  the Canada and Irish Codes and the FSANZ 
standard (Ref. 15.Ref. 206.Ref. 201.Ref. 203). 
One means to test for E. coli  O157:H7 and Salmonella  spp. as required under proposed § 
112.146(b) is to follow our guidance on sampling a nd testing spent irriga tion water or sprouts 
(Ref. 15).  The methods described in our guidance have  been validated to be effective on spent 
sprout irrigation water and sprouts (Ref. 15.Ref. 223.Ref. 224).  The effectiveness of detection 
methods can vary depending on multiple factors, in cluding but not limited to whether the sample 
tested is representative of the food, type of food, level of microf lora present, the enrichment 
procedure and type of test used.  Spent sprout irrigation water and sprout s have a high level of 
natural microflora that can interfere with detection (Ref. 15.Ref. 243).  Therefore, other methods 
that have been validated to be effective for ot her foods may not work for spent sprout irrigation 
water and sprouts.  Because the microflora in spent sprout irrigation water is more homogeneous 
compared to seeds or sprouts, sampling pro cedures described in our guidance for sprout 
irrigation water are relatively si mple.  In addition, spent sprout  irrigation water can be used 
directly in the test procedures described in our guidance, thus reducing the possibility of error 
(Ref. 15.Ref. 243).  Sampling spent sprout irrigation wate r or sprouts is an important testing 
procedure to ensure contaminated product does not enter commerce.  The testing procedures 361 
 
described in our guidance give ac curate results as quickly and simply as possible on the presence 
or absence of E. coli  O157:H7 and Salmonella  spp. 
Proposed § 112.150 would establish requirements for records that you must establish and 
keep regarding sprouts.  Under proposed § 112.150( a), you must establish and keep the required 
records in accordance with the requirements of proposed subpart O.  As discussed in section 
V.O. of this document, proposed subpart O would establish general requir ements applicable to 
all records.   
Proposed § 112.150(b) would require you to esta blish and keep the following records: 
documentation of your treatment of seeds or be ans to reduce microorgani sms of public health 
significance in the seeds or b eans, at your farm (proposed  § 112.150(b)(1)); your written 
environmental monitoring plan in accordance with the requirements of § 112.144 (proposed § 
112.150(b)(2)); your written sampling and testing pl an for each production batch of sprouts in 
accordance with the requirements of § 112.146(a) (proposed § 112.150(b)(3)); the results of any 
testing conducted in accordance with the requirements of §§ 112.143 and 112.144 (proposed § 
112.150(b)(4)); any analytical methods you use in lie u of the methods that are incorporated by 
reference in § 112.152  (proposed § 112.150(b)(5 )); and the testing method you use in 
accordance with the requirements of § 112.146(b)  (proposed § 112.150(b)(6)). We are proposing 
to require you to keep the above records specific to sprout operati ons in order to help document 
your compliance with the provisions of this rule.  We tentatively conclude that such records are 
needed for us to verify and you to ensure that appropriate measures are being followed consistently and correctly (e.g., your sampling pl an for spent sprout irrigation water from each 
production lot).  The records would also allow FDA or you to identify trends that might signal a 
need to adjust the measures in  your environmental monitoring pl an to improve its effectiveness 362 
 
and reliability (e.g., test results from your e nvironmental monitoring program may signal the 
need to enhance sprouting opera tion cleaning and sanitation).   
 N.  Subpart N – Analytical Methods Proposed subpart N would specif y methods of analysis for te sting the quality of water 
and the growing environment for sprouts, as required under proposed subparts E and M (see 
sections V.E. and V.M., respectively, of this document).   
Proposed § 112.151 would establish that you must te st the quality of water to satisfy the 
requirements of § 112.45 by one of three methods: (1 ) official methods of analysis published by 
the AOAC International; (2) sta ndards methods for the examination of water and wastewater as 
published by the American Public Health Associ ation; or (3) methods prescribed in the FDA 
Bacteriological Analytical  Manual, or by another method that is  at least equivalent to the above-
mentioned three methods in accuracy, precisi on and sensitivity in detecting E. coli
. 
Proposed § 112.151(a)(1) provides for the use of official methods of analysis published 
by AOAC International in th e latest edition of thei r publication “Official Methods of Analysis of 
the Association of Official Analytical Chemists,” 18th edition, revision 4 (published in 2011).  
The Official Methods of Analysis of AOAC In ternational (18th Ed., revision 4, 2011) would be 
incorporated by reference with the approval of the Director of the Federal Register in accordance 
with 5 U.S.C.  552(a) and 1 CFR Part 5.  
Proposed § 112.151(a)(2) would establish that methods of analysis published in the 
Standard Methods for the Examina tion of Water and Wastewater (21st Edition, 2005), American 
Public Health Association would be acceptable for testing the quality of wa ter.  In addition, the 363 
 
Standards Methods for the Examina tion of Water and Wastewater, (21st Ed., 2005), would be 
incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 5.   
Proposed § 112.151(a)(3) would establish that me thods of analysis published in Chapter 
4 of the FDA Bacteriological Analytical Manu al (Edition 8, Revision A, 1998) (BAM), as 
updated in June 2011, would be acceptable for testi ng the quality of water.  In addition, Chapter 
4 of the BAM (Edition 8, Revisi on A, 1998), as updated in June 2011, would be incorporated by 
reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 5.  With advances in science and as 
appropriate, FDA periodically updates the BAM to add newer methods or re vise existing ones.  
For the purposes of this proposed rule, we refer to Chapter 4 of the BAM (edition 8, revision A, 
published in 1988) as updated in June 2011.  Howe ver, should FDA update or revise the methods 
and procedures currently listed in Chapter 4 of  the June 2011 version, fo r the purpose of testing 
the quality of water, we encourage industr y to use such relevant, updated methods and 
procedures.   
Proposed § 112.151(a)(4) would provide for the use of a method that is at least equivalent 
in accuracy, precision, and sensitivity to the met hods in §§ 112.151(a)(1), (a)(2) or (a)(3).  Test 
kit methods are generally not published in the litera ture due to their proprie tary nature.  FDA is 
aware of programs, such as the AOAC Resear ch Institute’s Performance Tested Methods 
Program that provides an independent third-party re view of proprietary test method performance.  
Test methods demonstrated to meet acceptable performance criteria are granted Performance 
Test Methods (PTM) status.  The PTM certificati on assures users that an independent assessment 
has found that the test method performance meets an  appropriate standard for the claimed use.  
FDA would consider methods, particularly test  kit methods, approved by the PTM program or 
other similar programs acceptable for testing the quali ty of water.  FDA is also aware that there 364 
 
are numerous scientific testing and diagnostic development companies that have invented rapid 
tests and systems for pathogens and water qua lity.  Many of these products undergo rigorous 
internal quality control and performance testing, as well as re ceive additional third-party and/or 
regulatory approvals.  FDA is also aware that  the Environmental Protection Agency (EPA) 
approves analytical methods that industrial and municipal facilities use to determine pollutants of 
wastewater (published in 40 CFR Pa rt 136) and to meet federal re quirements or to demonstrate 
compliance with drinking water and ground water regulations (40 CFR 141.402 and 40 CFR 
141.403).  For example, the EPA, has approved the use of E*Colite® Test, m-ColiBlue 24® Test, and Colitag® Test for compliance monitori ng related to EPA’s Ground Water Rule.  FDA 
would consider these tests accepta ble for testing the quality of wa ter to satisfy the requirements 
of § 112.45.  
Proposed § 112.152 establishes the methods you must use to test the growing 
environment for Listeria
 spp. or L. monocytogenes  to satisfy the requirements of §§ 112.143(a) 
and 112.144.  As proposed, you must test environmental samples using the methods and 
procedures described in Chapter 10 of the BAM, “Listeria monocytogenes , Detection and 
Enumeration of Listeria monocytogenes  in Foods.”  Chapter 10 of the BAM (Edition 8, Revision 
A, 1998), as updated in April 2011, would be incor porated by reference in accordance with 5 
U.S.C. 552(a) and 1 CFR part 5. With advances in  science and as appropriate, FDA periodically 
updates the BAM to add newer methods or revise  existing ones.  For the purposes of this 
proposed rule, we refer to Chapter 10 of the BAM (Edition 8, revision A,  published in 1998) as 
updated in April 2011.  However, should FDA update or revise the methods and procedures 
currently listed in Chapter 10 of  the April 2011 version, for the purpose of testing the growing 365 
 
environment for Listeria  spp. or L. monocytogenes , we encourage industry to use such relevant, 
updated methods and procedures.  
Proposed § 112.152 would also provide for the us e of a method at least equivalent in 
accuracy, precision, and sensitiv ity in detecting Listeria  spp. or L. monocytogenes  as is the 
method described in Chapter 10 of the BAM .  For example, prescribed rapid detection kits with 
their respective enrichment media may be conditiona lly used to screen fo r presence of Listeria  
contaminants.  Isolates may be rapidly positivel y or negatively confirmed as L. monocytogenes  
by using specific test kits.  FDA is aware that there are numerous scientific testing and diagnostic 
development companies that have invent ed rapid tests and systems for Listeria  spp. or L. 
monocytogenes .  Many of these products undergo ri gorous internal quality control and 
performance testing, as well as r eceive additional third-party and/ or regulatory approvals.  As 
discussed above in proposed § 112.151( a)(4), FDA would consider me thods, particularly test kit 
methods, approved for example by the AOAC Resear ch Institute’s Performance Tested Methods 
Program PTM program or other simila r, acceptable for testing Listeria  spp. or L.  
monocytogenes.   
 
O. Subpart O – Requirements Applying to R ecords That You Must Establish and Keep 
As proposed, subpart O discusses the genera l requirements applicable to documentation 
and records that you must establish a nd maintain under proposed part 112.   
1. Comments Relevant to the Proposed Requirements 
We received several comments in response to th e 2010 FR notice that addressed issues relevant 
to establishing and maintaining documents and r ecords.  Comments expressed concern over the 
costs of complying with record keeping requirement s.  Several comments also stated that there 366 
 
should not be a requirement for electronic record keeping for farmers, es pecially if they are 
small-scale.  One comment requested that, to protect the confidentiali ty of individual farm 
businesses, any recordkeeping requirements be  accompanied by assurance that information 
accessed by federal government authorities with re spect to food safety protocols will remain 
confidential.  Another comment requested that we consider pr e-existing records kept by the 
produce industry for other purposes, so as to av oid duplication, while another farmer commented 
that records or documents would not ensure safety and, therefore,  asked that records should be 
required for only annual activitie s, such as employee training and surveys of surrounding land 
activities.  Finally, several comments indicated that the current legal liability system in the United States serves to discourag e any grower or packing house fr om keeping additional detailed 
records related to food safety and that such r ecords are subject to intr usive judicial subpoena 
power.  We believe that documentation of some practices  is critical to ensure that science-based 
minimum produce safety standards proposed in th is rule are adequately implemented on the 
farm.  Records are useful for keeping track of  detailed information over a period of time.  
Records can identify patterns of problems and, t hus, enable a farm to find and correct the source 
of problems.  Records are also useful for investigators during insp ections to determine 
compliance with requirements (e.g., by FDA in vestigators to determ ine compliance with 
requirements that would be established by this ru le, or by a third party au ditor that a farm or 
retailer may voluntarily engage unde r a business arrangement between the farm and the retailer).   
Therefore, we tentatively conclude  that records of only annual activities are in sufficient to ensure 
produce safety.  However, in determining those ci rcumstances in which records are necessary as 
part of science-based minimum standards that minimize the risk of serious adverse health 367 
 
consequences or death and provi de reasonable assurances that produce is not adulterated under 
section 402 of the FD&C Act, we considered the statutory direc tion in section 419(c)(1)(C) of 
the FD&C Act to comply with the Paperwor k Reduction Act (44 U.S.C. 3501 et seq.) “with 
special attention to minimizing” the recordk eeping burden on the business and collection of 
information as defined in that act.  We propose to require record s in instances where 
maintenance of detailed information is needed to keep track of measures directed at minimizing 
the risk of known or reasonably foreseeable h azards, where identifica tion of a pattern of 
problems is important to minimizing the risk of such hazards, or where they are important to 
facilitate verification and compliance with st andards and this cannot be effectively done by 
means other than a review of records.  See sect ion IV.E of this document for further discussion. 
We appreciate the concerns expressed by some co mmenters with respect to cost and burden to 
farms.  To the extent possible, we attempte d to propose documentation requirements that are 
risk-based and capable of being tailored to your  individual farm, taking into account the unique 
characteristics of the operation, the commod ities handled, and the operation’s growing, 
harvesting, packing, and holding procedures.  A large majority of growers, farmers, and 
producers indicated during listening sessions and other stakeholder di scussions that they already 
practice good agricultural practices  and keep adequate records.  They agreed that such 
recordkeeping is necessary.  Moreover, they indicat ed that the cost of a large scale recall event 
would have the potential to far exceed the cost of routine record keeping. 
As proposed, the recordkeeping re quirements allow the use of exis ting records and do not require 
duplication, provided such records sa tisfy all of the applicable requirements of this part (see 
proposed § 112.163).  In addition, per propos ed § 112.165, electronic records would be 
acceptable but would not be required by this subpar t.  Records would be acceptable under this 368 
 
subpart if kept in forms as diverse as hard c opies of handwritten logs, invoices, and documents 
reporting laboratory results, provided that  they are indelible and legible.  
We understand the concerns regarding confidentialit y.  Our disclosure of information is subject 
to the Freedom of Information Act (FOIA) (5 U.S.C. 552), the Trade Secrets Act (18 U.S.C. 
1905), the FD&C Act, and our implementing regulat ions under part 20, which include protection 
for confidential commercial information and trade secrets.  We note that many segments of the 
food industry already are subject to food safety-related recordk eeping requirements similar to 
those proposed in this subpart.  Other existing food safety regulati ons, such as the infant formula 
quality control procedures regulation (§ 106.100), the dietary supplem ent regulation (§ 111.605 
and § 111.610), the acidified foods regulation (§  114.100), the regulation on production, storage, 
and transportation of shell eggs (§ 118.10), the juice HACCP regulation (§ 120.12), and the 
seafood HACCP regulation (§ 123.9) require simila r record keeping.  In addition, many farmers 
that are part of the various programs such as National Organic Program and LGMA already have 
similar recordkeeping requirements (Ref. 45.Ref. 261).  Recordkeeping has proven useful for the 
above-mentioned food industries and, thus far, we are not aware that any of these industries has 
been adversely affected by exce ssive judicial subpoenas resul ting from their recordkeeping.  
2. Proposed Requirements Proposed subpart O would establish requirements that would be appl icable to all records required 
by part 112.  FDA tentatively concludes that th e requirements in subpa rt O describing how 
records must be established and maintained, incl uding the general requireme nts, record retention 
requirements, and requirements for official review and public disc losure, are applicable to all 
records that would be required under all subparts, because records that would be required under 369 
 
each of the subparts would aid farms in complyi ng with the requirements of part 112; and allow 
farms to show, and FDA to determine, co mpliance with the requirements of part 112. 
a. General Requirements As proposed, § 112.161(a)(1) requires  that your records include: (i) the name and location of 
your farm; (ii) actual values and observations obtained during monitoring ; (iii) an adequate 
description (such as the commodity  name, or the specific variety or brand name of a commodity, 
and, when available, any lot number or other iden tifier) of covered produce applicable to the 
record; (iv) the location of a gr owing area (for example, a specifi c field) or ot her area (for 
example, a specific packing shed) applicable to the record; and (v) the date and time of the 
activity documented.   The name and location of your farm and the date  and time would allow the owner, operator, or 
agent in charge of a farm (and, during inspectio n, an FDA investigator) to assess whether the 
record is current and establish th e relevance of the record to y our farm, which is necessary for 
review by regulators.  An adequate description of  covered produce would allow the farm to more 
readily track measures, identify a pattern of problems, and verify compliance.  Such a description 
will also allow the farm to identify specific produce for which the standards of this part have not been met, and to take appropriate meas ures as provided for under § 112.11.      
Recording actual values and observations dur ing monitoring are necessary to produce an 
accurate record.  Notations that monitoring measurem ents are  “satisfactory” or “unsatisfactory,” 
without recording the actual times and observation s (e.g., temperatures and turnings in treating 
biological soil amendments of an imal origin) are vague and subj ect to varying interpretations 
and, thus, will not ensure that requi red measures have been taken or standards have been met.  In 
addition, it is not possible to discern a tr end without actual measurement values.   370 
 
Proposed § 112.161(a)(1) is consistent with our HAC CP regulations for seafood and juice.  Our 
HACCP regulations for seafood and juice require that a ll records include the name and location 
of the processor; the date and tim e of the activity that the record reflects; the signature or initials 
of the person performing the operation; and where appropriate, the identity of the product and the 
production code, if any (§§ 123.9(a) and 120.12(b), re spectively).  Our HACCP regulations for 
seafood and juice also require that  records contain the actual values (such as temperature) and 
observations obtained during monitoring (§§ 123.6(c)(7) and 120.12(b)(4 ), respectively). 
Additional requirements in proposed § 112.161(a) incl ude that records must be created at the 
time an activity is performed or observed (pro posed § 112.161(a)(2)); be accurate, legible, and 
indelible (proposed § 112.161(a)(3)) ; and be dated, and signed or  initialed by the person who 
performed the activity documented (proposed § 112.161(a)(4)).  These requirements would ensure that the records are useful to the owner,  operator, or agent in 
charge of a farm in complying with the requirements of part 112, for example, in documenting 
compliance with monitoring requirements.  These proposed requirements would also ensure that 
the records would be useful to  FDA in determining compliance with the requirements of part 
112.  For example, the signature of the indi vidual who made the observation would ensure 
responsibility and accountability. In  addition, if there is a questi on about the record, a signature 
would ensure that the source of the record will be known. These proposed requirements are 
consistent with our HACCP regulations for s eafood and juice.  Our HACCP regulations for 
seafood and juice require that processing and othe r information be entered on records at the time 
that it is observed (§§ 123.9(a)(4) and 120.12(b)(4), respectively).  
As proposed, under § 112.161(b), when  records are required to be  established and kept in 
subparts C, E, F, L, and M of this part (§§ 112.30, 112.50, 112.60, 112.140, and 112.150), you 371 
 
must establish and keep documentation of actions you take when a standard in those subparts is 
not met. This documentation is necessary to s how that you have taken the steps reasonably 
necessary to minimize the risk of  serious adverse health conseque nces or death from the use of, 
or exposure to, covered produce, including those measures reasona bly necessary to prevent the 
introduction of known or reasonably foreseeable hazards into covered produce, and to provide 
reasonable assurances that the produce is not adu lterated under section 40 2 of the FD&C Act.  
For example, if under § 112.44(b) you are required to  discontinue the use of agricultural water 
and take corrective steps, this provision would require you to establish and k eep a record of the 
corrective steps that you took.  As proposed, § 112.161(c) would require a supervisor  or responsible party to review, date, and 
sign those records that are re quired under 112.50(b)(4), 112.50(b)(5 ), 112.60(b)(1), 112.60(b)(3), 
112.140, 112.150(b)(1), 112.150(b)(4), and 112.161(b).  Thes e records relate to  certain of your 
testing, monitoring, sanitizing, and corrective action activi ties.  As described above, one of the 
primary purposes for establishing and maintaining records is so that you can revi ew the records 
to see if the requirements of this  part have been met.  Requiring a signature from a supervisor or 
responsible party for these records emphasizes the importa nce of such a review.   
b. Storage of Records Proposed § 112.162 would establish the requiremen ts regarding where your records must be 
stored.  Proposed § 112.162(a) establishes that of fsite storage of records is permitted after 6 
months following the date the record was made if  such record can be retrieved and provided 
onsite within 24 hours of request for official  review.  FDA realizes that the proposed 
requirements for recordkeeping could require so me farms to store a significant quantity of 
records, and that there may not be adequate storage space in the farm for these records.  372 
 
Providing for offsite storage of most records after 6 months would enable a farm to comply with 
the proposed requirements for record retention while reducing the amount of space needed for 
onsite storage of the records wit hout interfering with th e purpose of record retention, because the 
records will be readily available.  Proposed § 112.162(b) would clarify that  electronic records are 
considered to be onsite at your farm if they are accessible from an onsite location at your farm.  
For example, we would consider electronic records to be onsite if they were available from your 
computer, including records transmitted to your computer via a network connection or accessed 
from either the internet or electronic or digital storage applications.   Proposed § 112.162 is consistent with our HACCP  regulations for seafood and juice.  Our 
HACCP regulation for seafood provides for transfer  of records if record  storage capacity is 
limited on a processing vessel or at a remote processing site, if th e records could be immediately 
returned for official review upon request (§ 123.9(b)(3)). Our HACCP regulation for juice  
permits offsite storage of processing records after 6 months followi ng the date that the 
monitoring occurred, if such records can be retrieved and provided onsite within 24 hours of 
request for official review and considers electro nic records to be onsite if they are accessible 
from an onsite location (§ 120.12(d)(2)). We s eek comment on the appropriateness of the 
proposed recordkeeping requirements.  c. Use of Existing Records As proposed, § 112.163 would clarify th at the regulations in this pa rt do not require duplication 
of existing records if those record s contain all of the information re quired by this part.  In this 
provision, we seek to minimize the burden of keeping records to that which is necessary to accomplish the intended purposes of this part.   373 
 
For example, as proposed, you are not required to duplicate existing records, such as records kept 
to satisfy the requirements of the National Organi c Program, if those records contain all of the 
information required by this part.  Additionally, you are not required to keep all of the information required by this part in one set of re cords.  Similarly, if you have records containing 
some but not all of the required information, this  proposed regulation provides you the flexibility 
to keep any additional informati on required by this part either se parately or combined with your 
existing records.  While we propose this provision to give you the greatest degree of flexibility, 
we remind you that keeping records together in one place likely will exped ite review of records 
in the event of a public health  emergency or during an FDA inspection or investigation.  
d. Length of Time for Records Storage  Proposed § 112.164(a) would requi re that you keep records required by this part for two 
years after the date the record was created.  Retain ing records for at least this length of time is 
necessary to ensure that the re cords are available for reference during verification activities as 
well as during FDA inspections.  It is also critica l for documentation and observation of trends of 
the food safety risks that may affect your operation over time.  Multi-year retention of records 
allows an owner, operator, or agency to bett er understand and proactiv ely respond to the risk 
factors affecting his or her farm.  Since many we ather events, such as drought or floods, which 
have an influence on the safety of fresh produce ar e relatively rare; maintaining historical records 
to inform the development of preventive contro ls specific to a given ope ration is invaluable.  
Similarly, proposed § 112.164(b) would establish that records that relate to  the general adequacy 
of the equipment or processes being used by a farm , including the results of scientific studies and 
evaluations, must be retained at the farm for at least two years af ter the use of such equipment or 
processes is discontinued. 374 
 
Certain growers and packers of covered produce curr ently retain records for at least two years.  
For example, produce operations certified by the National Organic Program must maintain their 
records relating to the production, harvesting, and handling of “org anic” agricultural products for 
at least five years beyond th e creation of the records (7 CFR 205.103).  USDA’s Agricultural 
Marketing Service requires that restricted use pe sticide records be maintained for two years from 
the date of pesticide application (7 CFR 110.3) .  Under USDA’s regulations implementing the 
Perishable Agricultural  Commodities Act, 1930 (PACA), p ackers who pack and sell another 
firm’s produce and growers and packers who volunt arily obtain a PACA li cense are required to 
preserve records for two years (7 CFR 46.14).  Under the Florida Tomato Rule (“Tomato Good Agricultural Practices [T-GAP] & To mato Best Management Practices”) 
(Ref. 262), firms must 
keep records documenting adherence to T-GAPs,  “including those addressing environmental 
review, water usage, record of completed education and tr aining, pest control and crop 
production practices for the operation,” for at least three calendar years (Ref. 44).  Participants in 
the California Leafy Green Marketing Agreement (LGMA) must maintain their records kept 
under the LGMA agreement for two years (Ref. 45).   
e. Acceptable Formats for Records As proposed, § 112.165 would require that you keep r ecords as either: (a) or iginal records; (b) 
true copies (such as photocopies , pictures, scanned copies, mi crofilm, microfiche, or other 
accurate reproductions of the original records); or (c) electronic records in compliance with part 
11.  True copies of records should be of sufficient quality to dete ct whether the original record 
was changed or corrected in a manner that obscu red the original entry (e.g., through the use of 
white-out).   Proposed § 112.165 w ould provide flexibility for mechanisms for keeping records 
while maintaining the integrity of  the recordkeeping system.  Th e proposed requirement allowing 375 
 
true copies is consistent w ith other regulations such as our Good Manufacturing Practices 
(GMPs) regulation for dietary supplements (§  111.605(b)) and provides options that may be 
compatible with the way reco rds are currently being kept in plants and facilities.  
Proposed § 112.165 also would require that electronic records be kept  in accordance with part 11 
(21 CFR part 11).  Part 11 pr ovides criteria for acceptance by FDA, under certain circumstances, 
of electronic records, electronic signatures, a nd handwritten signatures executed to electronic 
records as equivalent to pape r records and handwritten signatu res executed on paper.  The 
proposed requirement clarifies and acknowledges that records required by part 112 may be 
retained electronically, provided th at they comply with part 11. 
FDA tentatively concludes that it is appropriate to apply the requirements of part 11 to the 
records that would be required to be kept under part 112.  Ho wever, we request comment on 
whether there are any circumstances that would warrant not applying part 11 to records that 
would be kept under part 112.  For example, would a requirement that electronic records be kept 
according to part 11 mean that current electronic records and recordkeeping systems would have 
to be recreated and redesigned, which we de termined to be the case in the regulation 
Establishment and Maintenance of Records Under the Public Health Secu rity and Bioterrorism 
Preparedness and Response Act of 2002 (69 FR 71562; December 9, 2004 (the BT records regulation))?  For the purposes of the records requirements in the BT records regulation, we 
concluded that it was not necessary for new reco rdkeeping systems to be established as long as 
current practices would satisfy the requirements of the Act and, therefore, we exempted the 
records from the requirements of part 11 (21 CFR § 1.329(b)).  We also exempted records related to certain cattle materials prohi bited from use in human food and cosmetics from part 11 (21 
CFR §§ 189.5(c)(7) and 700.27(c)(7),  respectively).  We also seek comment on whether we 376 
 
should allow additional time for electronic record s to be kept in accordance with part 11.  
Comments should provide the basis for any view  that the requirements of part 11 are not 
warranted. f. Making Records Available for Official Review 
Proposed § 112.166(a) would require  that you have all record s required under this part 
readily available and accessible during the rete ntion period for inspection and copying by FDA 
upon oral or written request, except that you ha ve 24 hours to obtain reco rds you keep offsite and 
make them available and accessible to FDA fo r inspection and copying.  Our access to records 
required under this part would e xpedite efforts to document and ensure that covered produce is 
not adulterated, as well as to quickly and accu rately identify any adulterated covered produce 
and prevent it from reaching consumers.  For example, during a foodborne illness outbreak or contamination investigation, records access would he lp enable you and us to pinpoint the source 
and cause of contamination in a timely manner.  This provision is cons istent with our HACCP 
regulations for juice (§ 120.12( e)) and seafood (§ 123.9(c)), and dietary supplement GMPs (§ 
111.610(b)), which require that al l records required under those rulemakings be available for 
review and copying at reasonable tim es.  This provision also is similar to requirements in the 
infant formula quality control procedures re gulation (§ 106.100(l)) stati ng that manufacturers 
make readily available for authorized inspection all records required under those regulations.  In 
addition, this proposed provision is similar to provisions in the juic e HACCP regulation (§ 
123.9(f)) and in the regulation on production, storage, and trans portation of shell eggs (§ 
118.10(d)) that require that firms be able to retrieve and provide a ny records stored offsite within 
24 hours of request for official review. 377 
 
Proposed § 112.166(b) would require that if yo u use electronic techniques to keep 
records, or to keep true copies of records, or if you use reduction techniqu es such as microfilm to 
keep true copies of records, th at you provide the records to us in a format in which they are 
accessible and legible.  For example, you might provide us with an unencrypted copy of an 
electronic record or provide us with suitabl e equipment for viewing, printing, and copying a 
record.  This provision would enable us to co mprehend your records in a timely manner.   
Consistent with proposed § 112.166(a), proposed § 112.166(c) would require th at if your farm is 
closed for a prolonged period, the records may be transferred to some other reasonably 
accessible location but must be returned to your farm within 24 hours for official review upon 
request.  Allowing for transfer of records will give practical storage relief to seasonal operations or those closed for other reasons  for prolonged periods.  Proposed  § 112.166(c) is consistent with 
our HACCP regulations for seafood and juice, which provide for transfer of records for facilities 
closed for prolonged periods (between seasonal pack s, in the case of juice)  if the records could 
be immediately returned for official revi ew upon request (§ 123.9( b)(3) and 120.12(d)(3) for 
seafood and juice, respectively).  g. Disclosure Requirements Proposed § 112.167 would specify that records required by this part ar e subject to the disclosure 
requirements under part 20 of this chapter.  FDA’s regulations in 21 CFR part 20, FOIA, the 
Trade Secrets Act [18 U.S.C. 1905], and th e FD&C Act govern FDA’s disclosures of 
information, including treatment of confidentia l commercial information and trade secret 
information.  Our general policies, procedures , and practices relating to the protection of 
confidential information received  from third parties would apply to information received under 
this rule.  Proposed § 112.167 is consistent with, but framed differently than, the disclosure 378 
 
provisions of the HACCP regulations fo r seafood and juice (§§123.9(d) and 120.12(f), 
respectively).   Proposed § 112.167 is framed simila rly to the disclosure provisions for records 
that must be kept under part  118 (Prevention of Salmonella  Enteritidis  in Shell Eggs During 
Production); under § 118.10(f), records required by part 118 are subject to the disclosure 
requirements under part 20.    
P. Subpart P – Variances 1. Relevant provisions of S ection 419 of the FD&C Act 
In section 419(c), the FD&C Act establishes criteria for the fina l regulation, including that the 
final regulation “permit States a nd foreign countries from which food is imported into the United 
States to request from the Secretary variances from the requirements of the regulations, subject 
to [section 419(c)(2) of the FD&C  Act], where the State or foreign country determines that the 
variance is necessary in light of  local growing conditions and that  the procedures, processes, and 
practices to be followed under the variance are reasonably likely to ensure that the produce is not 
adulterated under section 402 [of th e FD&C Act] and to provide th e same level of public health 
protection as the requirements of the regulations adopted under  [section 419(b) of the FD&C 
Act]” (section 419(c)(1)(F)).  Sectio n 419(c)(2) specifies the following:  
“REQUESTS FOR VARIANCES. -- A State or foreign country fr om which food is imported 
into the United States may in writing request a variance from the Secretary. Such request shall 
describe the variance requested and present inform ation demonstrating that  the variance does not 
increase the likelihood that the food for which the variance is re quested will be adulterated under 
section 402, and that the variance provides the same level of pub lic health protection as the 379 
 
requirements of the regulations adopted under [sec tion 419(b) of the FD&C Act].  The Secretary 
shall review such requests in a reason able timeframe” (section 419(c)(2)(A)).  
“APPROVAL OF VARIANCES. -- The S ecretary may approve a variance  in whole or in part, as 
appropriate, and may specify the scope of applicabili ty of a variance to other similarly situated 
persons” (section 419(c)(2)(B)).  “DENIAL OF VARIANCES. -- Th e Secretary may deny a variance request if the Secretary 
determines that such variance is not reasonably likely to  ensure that the fo od is not adulterated 
under section 402 and is not reas onably likely to provide the same level of public health 
protection as the requirements of the regula tion adopted under [section 419(b) of the FD&C 
Act]. The Secretary shall notify th e person requesting such variance of the reasons for the denial” 
(section 419(c)(2)(C)).  “MODIFICATION OR REVOCATION OF A VARIANCE. -- The Secretary, after notice and an 
opportunity for a hearing, may modify or revoke a variance if the Secretary determines that such 
variance is not reasonably likely to ensure that  the food is not adulte rated under section 402 and 
is not reasonably likely to provi de the same level of public health  protection as the requirements 
of the regulations adopted under [section 419(b)  of the FD&C Act]” (section 419(c)(2)(D)). 
2. Proposed Requirements Consistent with the statutor y provisions mentioned above, in this subpart, we propose a 
process by which variances from one or more requirements of part 112 may be requested by a 
State or foreign government, information that mu st accompany such requests, and the procedures 
and circumstances under which FDA may grant or  deny such requests, and modify or revoke 
such variances.  Variances a pproved by FDA would be limited to  the requirements of part 112 
specified by FDA, and have no effect on the appl ication of other provisions of the FD&C Act. 380 
 
Consistent with section 419( c)(2)(A) of the Act, proposed  § 112.171 would establish that 
a State or foreign country from which food is impor ted into the U.S. may request a variance from 
one or more of  the requirements proposed in  part 112, where the Stat e or foreign country 
determines that the variance is necessary in light of local growing conditions (proposed § 
112.171(a)); and the procedures, processes, and pr actices to be followed under the variance are 
reasonably likely to ensure that the produce is  not adulterated under S ection 402 of the Act and 
to provide the same level of public health prot ection as the requirements of proposed part 112 
(proposed § 112.171(b)).  Such a determination would likely be based on the particular crop, 
climate, soil, geographic, and environmental conditions of a particular region, as well as 
processes, procedures, or practices followed in  that region.  Given th e diversity of covered 
produce commodities and covered activities subj ect to the requirements of part 112, we 
tentatively conclude that this provision provides sufficient flex ibility while ensuring the same 
level of public health protection for covered prod uce.  For example, a State or foreign country 
may consider that the historical performance of  an industry within their jurisdiction (e.g., as 
indicated by the epidemiological record) and the combination of measures taken by that industry 
merits requesting a variance from some or all pr ovisions of this proposed rule.  In requesting a 
variance, among other things, the State or foreign country would submit information that, while 
the procedures, processes and pr actices to be followed under th e variance would be different 
from those prescribed in this pr oposed rule, the requested  variance is reasonably likely to ensure 
that the produce is not adulte rated under section 402 of the FD&C Act and provide the same 
level of public health protecti on as the requirements of the final regulations (see proposed 
112.173).  FDA would encourage consideration of these kinds of submissions, and welcomes 
requests for pre-petition consulta tions, including meetings, with interested States or foreign 381 
 
governments to facilitate the de velopment of variance petitions, incl uding data and information 
that would be needed to demonstrate that the variance is necessary in light of local growing 
conditions and that the procedures, processes, an d practices to be followe d under the variance are 
reasonably likely to ensure that the produce is  not adulterated under S ection 402 of the Act and 
provide the same level of public health protect ion as the requirements in this rule, when 
finalized.  As discussed in section IV.K, FDA is proposing extended compliance dates for this 
proposed rule.  We expect that these compliance pe riods would allow sufficient time for variance 
petitions to be developed, submitted, and revi ewed by FDA.  We request comment on the 
compliance periods. 
In proposed § 112.172, we propose to establish that  a request for a variance, as described 
in proposed § 112.171, must be submitted by the competent authority (e.g., the regulatory authority for food safety) for the state or foreign government to FDA in the form of a citizen petition in accordance with 21 CFR 10.30.   
In proposed § 112.173, we propose that, in additi on to the requirements set forth in § 
10.30, the Statement of Grounds (whi ch is specified under § 10.30(b )) such petition requesting a 
variance must include a statement that the applicab le State or foreign country has determined that 
the variance is necessary in light  of local growing conditions and that the procedures, processes, 
and practices to be followed under the variance are reasonably likely to ensu re that the produce is 
not adulterated under Section 402 of the Act and to provide the same level of public health 
protection as the requirements of this part (p roposed § 112.173(a)).  In addition, the Statement of 
Grounds would be required to describe with pa rticularity the variance requested, including the 
persons to whom the variance would apply and the provision(s) of part 112 to which the variance 
would apply (proposed § 112.173(b)); and pres ent information demonstrating that the 382 
 
procedures, processes, and pract ices to be followed under the va riance requested are reasonably 
likely to ensure that the produce is not adulte rated under Section 402 of the Act and to provide 
the same level of public health protection as the requirements of proposed part 112 (proposed § 
112.173(c)).  Under these provisions, a State or foreign country would be required to submit 
relevant and scientifically-valid information or materials specific to the covered produce or covered activity to support th e petitioner’s determination that  the variance requested is 
reasonably likely to ensure that the produce is  not adulterated under S ection 402 of the Act and 
to provide the same level of public health protecti on as the requirements of this part.  This would 
include information about the crop, climate, soil , and geographical or en vironmental conditions 
of a particular region, as well as the processes, procedures, or pr actices followed in that region.  
  Proposed § 112.174 establishes our presumption that information submitted in a petition requesting a variance and comments submitted on su ch a petition, including a request that a 
variance be applied to its simila rly situated persons, does not c ontain information exempt from 
public disclosure under part 20 of this chapter and would be made  public as part of the docket 
associated with this request.  We do not beli eve that information exempt from disclosure under 
part 20 of this chapter is the type of information that FDA is requiring to be submitted in such a petition or that would be relevant in any co mments submitted on such a petition.  We also 
believe that providing full public a ccess to this information is impor tant to ensuring transparency 
and for the opportunity for states and forei gn governments to request similar variances for 
similarly situated persons.  Therefore, we expect  to make these submissions publicly available.  
Proposed § 112.175 would establish the Director or Deputy Directors of the Center for 
Food Safety and Applied Nutrition (CFSAN), or the Director of the Office of Compliance, 383 
 
CFSAN as the responsible official  for responding to a request for a variance from one or more 
requirements in proposed part 112.   
Proposed § 112.176 would establish the genera l procedures applying to a petition 
requesting a variance from one or more requ irements in proposed part 112.  Proposed § 
112.176(a) would provide that the procedures sets forth in § 10.30 govern the process by which 
FDA responds to a petition request ing a variance.  Section 10.30 of  this chapter specifies the 
requirements for any citizen petition submitted by a person (including a petitioner who is not a 
citizen of the United States) to FDA.  Pr oposed § 112.176(b) would es tablish that, under § 
10.30(h)(3) of this chapter, we will p ublish a notice in the Federal Register , requesting 
information and views on the filed petition, incl uding information and views from persons who 
could be affected by the variance if  the petition were to be granted (either because their farm is 
covered by the petition or as a person similarly si tuated to persons covered by the petition).  For 
example, similarly situated persons may in clude those whose farm operates under similar 
circumstances with similar procedures, processes,  and practices as those covered by the petition.  
Proposed § 112.176(c) would establish that, und er § 10.30(e)(3), FDA will respond to the 
petitioner in writing and will publ ish a notice on our website announc ing our decision to either 
grant or deny the petition.  Proposed § 112.176(c )(1) would establish that, if we grant the 
petition, either in whole or in part, we will speci fy the persons to whom the variance would apply 
and the provision(s) of this  part to which the variance would apply. Proposed § 112.176(c)(2) 
would establish that, if FDA denies the petition (including partial denials), FDA will explain the 
reason(s) for the denial in its written response to the petitioner and in the notice on our website 
announcing the decision to deny.  Under proposed  § 112.176(d), we propose to make readily 
accessible to the public, and period ically update, a list of  filed petitions requesting variances, 384 
 
including the status of each petition (for exampl e, pending, granted, or denied).  The provisions 
in proposed § 112.176 would ensure transparency  in FDA’s activities and decision-making, 
which allows the public to better understand th e agency’s decisions, increasing credibility and 
promoting accountability.   
Proposed § 112.177 would establish circumstan ces under which an approved variance 
could apply to any person other than those identified in the petition requesting the variance.  
Under proposed § 112.177(a), a State or  a foreign country that belie ves that a variance requested 
by a petition submitted by another State or foreign c ountry should also apply to similarly situated 
persons in its jurisdiction may re quest that the variance be applied to its similarly situated 
persons by submitting comments in accordance with § 10.30.  These comments must include the information required in § 112.173.  If FDA determin es that these comments should instead be 
treated as a separate request for a variance, FD A will notify the State or foreign country that 
submitted these comments that a separate request must be submitted in accordance with §§ 
112.172 and 112.173.  Moreover, under proposed § 112.177(b), we propose that if we grant a 
petition requesting a variance, in whole or in part, we may specify  that the variance also applies 
to persons in a specific location who are similarly situated to t hose identified in the petition.  
Consequently, under proposed § 112.177(c), if we sp ecify that the variance also applies to 
persons in a specific location who are similarly situat ed to those identified in the petition, we will 
inform the applicable State or foreign country wh ere the similarly situated  persons are located of 
our decision in writing and will publish a notice on our website announcing our decision to apply the variance to similarly situated persons in that particular location.  We tentatively conclude that 
the provisions in proposed § 112.177 ensure consid eration of the application of variances to 385 
 
similarly situated persons to and provide for tran sparency and accountability  in FDA’s review of 
requests and decision-making. 
Proposed § 112.178 would provide that we ma y deny a variance request if it does not 
provide the information required under propos ed § 112.173 (including the requirements of § 
10.30), or if we determine that the variance is no t reasonably likely to ensure that the produce is 
not adulterated under Section 402 of the Act and to provide the same level of public health 
protection as the requirements of this part.  Fo r example, we would expect to deny a petition if 
the State or foreign government failed to subm it scientifically-valid data, information, or 
materials to demonstrate that th e procedures, processes, or pr actices to be followed under the 
requested variance are reasonabl y likely to ensure that the pr oduce is not a dulterated under 
Section 402 of the Act and to provide the same  level of public health protection as the 
requirements of proposed part 112. 
Proposed § 112.179 would specify that a vari ance approved by FDA becomes effective 
on the date of our written decision on the petition. 
Under proposed § 112.180, we would be able to  modify or revoke an approved variance 
if we determine that such vari ance is not reasonably likely to ensure that the produce is not 
adulterated under Section 402 of the Act and to provide the same level of public health 
protection as the requirements of proposed part 112.  For example, we may deem it necessary to 
modify terms and conditions of the variance based on a review of  updated scientific data or 
factual information that is applicable to th e covered produce and procedures, processes, or 
practices followed under the variance.   
Proposed § 112.181 would establish th e procedures that apply if FDA determines that an 
approved variance should be modified or revoke d.  Under § 112.181(a), we would provide notice 386 
 
of such a determination as follows: (1) We will notify a State or a foreign country directly, in 
writing at the address id entified in its petition, if we determine that a variance granted in 
response to its petition should be modified or revoked.  Our direct, wr itten notification will 
provide the State or foreign count ry with an opportunity to re quest an informal hearing under 
Part 16 of this chapter; (2) We will publish in the Federal Register  a notice of our determination 
that a variance should be modified or revoked.  Th is notice will establish a public docket so that 
interested parties may submit written submi ssions on our determination; and (3) When 
applicable, we will: (i) Notify in writing any States or foreign c ountries where a variance applies 
to similarly situated persons of our determin ation that the variance should be modified or 
revoked; (ii) Provide those States or foreign countries with an oppor tunity 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 secti on public notification of  our decision to modify or revoke the 
variance granted to States or fo reign countries in which similarl y situated persons are located. 
Under § 112.181(b), we would consider submissi ons from affected States or foreign 
countries and from other interested parties as fo llows: (1) We will consider requests for hearings 
by affected States or foreign countries under part 16 of this chapter.  If FDA grants a hearing, we 
will provide the State or foreign country with an  opportunity to make an oral submission.  We 
will provide notice on our website of the hearing, in cluding the time, date, and place of hearing.  
If more than one State or fore ign country requests an informal hearing under part 16 of this 
chapter about our determination that a particul ar variance should be modified or revoked, we 
may consolidate such requests (for example, in to a single hearing); and (2) We will consider 
written submissions submitted to the public docket from interested parties.  387 
 
Under § 112.181(c), we would provide notice of our final decision as follows: (1) On the 
basis of the administrative record, FDA will issu e a written decision, as provided for under Part 
16 of this chapter; and (2) We will publish a notice of our decision in the Federal Register . The 
effective date of the decision will be the date of publication of the notice. 
We tentatively conclude th at these provisions are nece ssary not only to ensure 
transparency and accountability in FDA’s activit ies and decision-making, but also to provide 
relevant parties with an o pportunity for due process. 
Finally, in proposed § 112.182, we would provi de examples of permissible types of 
variances. These examples of variances from cer tain requirements in proposed part 112 are 
consistent with our proposed provisions in s ubpart B for alternatives from requirements in 
proposed part 112.  A State or foreign govern ment may request a variance from other 
requirements in proposed part 112, provided the conditions described in proposed § 112.171 are 
met. 
3. Conforming Amendment to 21 CFR Part 16 
We propose to amend § 16.1(b)(1) to include Sec tion 419(c)(2)(D) of the FD&C Act relating to 
the modification or revocation of a variance from the requiremen ts of Section 419 of the FD&C 
Act, to the list of statutory and regulatory provisions under which re gulatory hearings are 
available.  
Q.  Subpart Q – Compliance and Enforcement  1. Overall Strategy for Implementation and Compliance FDA expects this proposed rule to improve produce safety to the extent the proposed 
requirements related to practices  are actually implemented by farms.  Many farms already follow 388 
 
some or all of the proposed practices, but we re cognize that, when finaliz ed, the proposed rule 
will be the first national standard for on-farm practices relate d to produce safety and that it will 
take time and a concerted, community-wide effort for the wide range of farms to come into full 
compliance.  FDA is committed to working with the produce community and with partners in the 
U.S. Department of Agriculture, state agencies , and foreign governments to  facilitate compliance 
through education, technical assistan ce and regulatory guidance.   
We anticipate that compliance will be ach ieved primarily through the conscientious 
efforts of farmers, complemented by the effo rts of state and local governments, extension 
services, private audits and certifications, and other private sector s upply chain management 
efforts.  We also recognize that the time need ed to comply will vary, so we are proposing to 
phase in compliance dates based on farm si ze (see section IV.K of this document).  
Under the FD&C Act, FDA has authority to inspect produce farms and can take 
enforcement action when needed to prevent significant hazards from entering the food supply or 
in response to produce safety problems, although F DA faces severe constraints in inspection and 
enforcement when it comes to foreign farms.  FDA’s inspection resources are very limited, however, in relation to the number of produce farms and the many other food production, 
processing and storage settings for which FDA ha s regulatory responsibility.  Thus, as outlined 
below, FDA inspection will play  an important but necessarily limited role in the overall 
compliance effort.  FDA invites comment on all aspects of its compliance strategy.          
2. Education, Technical Assist ance and Regulatory Guidance 
Education and technical assist ance is the foundation of our intended compliance strategy.  
As discussed in section II.D. above, FDA has, t ogether with USDA AMS,  established a jointly-
funded Produce Safety Alliance (PSA), a public-p rivate partnership that will develop and 389 
 
disseminate science- and risk-b ased training and education progr ams to provide produce growers 
and packers with fundamental f ood safety knowledge.  A first phase  of PSA’s work is intended 
to assist farms, especially small and very small farms, in establishing food safety programs consistent with the GAPs Guide and other exis ting guidances so that they will be better 
positioned to comply when we issue a final produce safety rule under section 419 of the FD&C Act.  As this rulemaking progresses, FDA will work to ensure that the PSA materials are 
modified, as needed, to be consistent with th e requirements of the produce safety rule.  FDA 
intends to work with federal, State, and local  officials, industry, and academia through the PSA 
to assist farmers to implement measures necessary  to minimize the risk of serious adverse health 
consequences or death from cons umption of covered produce.  
We also will work to provide education a nd technical assistance th rough other sources of 
information that are familiar to the produce fa rming community (such as Cooperative Extension, 
land grant universities, trade associations, and foreign partners and JIFSAN to reach farmers 
exporting covered produce into the U.S. in their lo cal languages).  We plan to work with these 
and other stakeholders to develop a network of in stitutions that can provide technical assistance 
to the farming community, especially small and very small farms, as they endeavor to comply with the provisions of the final rule.   
FDA intends to further facilitate compliance with a final produce safe ty rule through the 
development and dissemination of guidance, in  multiple languages, on procedures, conditions, 
and practices that farms can implement to reduc e the risk of known or reasonably foreseeable 
hazards.  Section 419(e) of the FD&C Act requi res FDA to develop guidance “for the safe 
production and harvesting of specific types of fresh produce under [section 419]” and to hold at 
least three public meetings in di verse geographical areas of the U.S. as part of an effort to 390 
 
conduct education and outreach rega rding the guidance.  Consistent  with this st atutory provision, 
FDA plans to develop guidance materials, including additional guidances specific to 
commodities, practices, and conditions, as needed  and informed, in part, by stakeholder input, 
including that received during public meetings. 
Section 419(a)(4) of FSMA states  that “the Secretary shall prioritize the implementation 
of the regulations under this sec tion for specific fruits and vegeta bles that are raw agricultural 
commodities based on known risks which may include  a history and severity of foodborne illness 
outbreaks.”  As discussed immediately above, we  intend to fulfill this mandate by (1) conducting 
extensive outreach and educational efforts fo cused on the known risks of specific types of 
produce and specific types of agri cultural practices applied to such produce; (2) focusing our 
inspection and enforcement efforts on farms that present the greatest risk based, in part, on past 
association with outbreaks, contamination, or th e known risks of their ag ricultural practices and 
conditions and/or their specific types of produce; and (3) devel oping guidance materials related 
to the rule (including commod ity-specific guidances) focused on known risks.  We request 
comment on this approach and on specific strategies  we should employ in order to best prioritize 
our implementation of the rule in this manner. 
3. Supply Chain Management FDA anticipates that significant incentives and accountability for compliance with a final 
produce safety rule will come through non-regul atory audits and supply chain management 
initiated by private entities.    
As discussed in section II.F.2. of this document, a number of retail produce buyers 
currently require, as a condition of  sale, that their pr oduce suppliers comply with and be audited 
by third parties for conformance with the FDA GAPs guide.  USDA AMS also offers a GAPs 391 
 
and Good Handling Practices (GAP&GHP) Audit Verification Program.  USDA AMS and the 
California Department of Food and Agriculture (CDFA) have developed and are implementing 
the California Leafy Greens Marketing Agreemen t (CA LGMA) to protect public health via 
compliance with the food safety practices that are accepted by the LGMA board (Ref. 45).  
Compliance with such practices is further verifi ed for members and signatories to the agreement 
through mandatory government audits by CDFA a uditors who are trained and licensed by USDA 
AMS (Ref. 263).  Leafy greens growers in Arizona have  adopted a similar marketing agreement 
and audit structure for their growers (Ref. 32).   
At the request of industry, the USDA AMS in 2009 held seven hearings throughout the 
United States to solicit input from the leafy gr eens industries across the U.S. regarding their 
desire to develop a proposed national marketi ng agreement for leafy greens.  A decision 
regarding the proposed USDA AM S national marketing agreement for leafy greens is currently 
pending, but FDA and USDA are committed to worki ng together to harmonize the provisions of 
any national or regional marketing agreements fo r produce with the provisions of any final rule 
FDA issues under section 419 of the FD&C Act.  Rigorous audits conducted under national or 
regional marketing agreements can be an impor tant tool for fosteri ng compliance with the 
produce safety rule. 
FDA also intends to issue notices of propos ed rulemaking implementing sections 418 and 
805 of the FD&C Act (sections 103 and 301 of FSMA).  FDA is aware of the diversity in quality 
of audits and the need to streng then that system, but we anticipate that audits will be an 
important source of accountability for compliance with a final produce safety rule.   
4. Inspections 392 
 
With a community as large and diverse as the produce farming industry, it is not 
reasonable to expect that industry-wide complia nce can be gained primarily through inspection 
and enforcement, though, of course, inspection a nd enforcement must be a component of our 
efforts.  Inspections will, of necessity, be targeted to those farms that present the greatest risk based, in part, on their association with past ou tbreaks or contamination events and the risk 
associated with the agricultural practices they  apply in the growing, harvesting, packing, and 
holding of covered produce.   
FDA intends to work collaboratively with our federal and State regulatory partners to use 
available inspection resources to conduct risk-bas ed inspections of farm s for compliance with a 
final produce safety regulation.  Section 702(a)(1)( A) of the FD&C Act [21 U.S.C. 372(a)(1)(A)] 
expressly authorizes FDA to conduct examinations  and investigations fo r the purposes of the 
FD&C Act through any health, food, or drug offi cer or employee of any State, Territory, or 
political subdivision thereof (such as a locality),  duly commissioned to act on behalf of FDA.  
Qualified State, Territorial, or local regulatory o fficials may be commissioned or serve under 
contract with FDA to conduct examinations, insp ections, and investigations for purposes of the 
FD&C Act.  In addition, secti on 702(a)(2) [21 U.S.C. 372(a)(2)] expressly authorizes FDA to 
conduct examinations and investigations for th e purposes of the FD&C Act through officers and 
employees of another Federal department or agenc y, subject to certain conditions set forth in that 
section.  We expect to continue to cooperatively leverage the re sources of federal, State, and 
local government agencies in this way as we st rive to obtain industry-wide compliance with a 
final produce safety rule. 
Section 419(b)(2)(A) of the FD&C Act spec ifically instructs FDA to “provide for 
coordination of education and enforcement activi ties by State and local officials, as designated 393 
 
by the Governors of the respective States or the appropriate elected  State official as recognized 
by State statute.”  Consistent with this provision and with the direction to  improve the training of 
State, local, territorial, and trib al food safety officials under S ection 1011 of the FD&C Act (21 
U.S.C. 399c, added to the FD&C Act by section 209 of FSMA), FDA intends to work closely 
with extension and education organizations and St ate, local, territorial, and tribal partners to 
develop the tools and training prog rams needed to facilitate cons istent inspection and regulatory 
activities associated with the requ irements of a final produce safety  rule.  We expect to build on 
our collaboration with State, local , territorial, and tribal officials in the development of tools and 
training for use by inspectors in farm investig ations on issues specific to food safety during 
growing, harvest, packing and holding produce.   
FDA anticipates that some States may choos e to adopt requiremen ts modeled after the 
provisions of a final federal produce safety ru le and may choose to perform inspections under 
their own authorities to enforce those provisions of their state la ws.  Such actions would further 
drive compliance with a final federal produce safety rule.  
5. Comments Related to the Proposed Provisions 
We received many comments on strategies for compliance, including comments from 
farmers, consumers, retail, State, federal and foreign governments, academia, trade associations 
and industry groups, and a non-profit research and advocacy organization.  These comments 
broadly expressed strategies for compliance that included specific suggestions on how to ensure 
that all covered produce is in compliance with a final rule.  Several comments recognized the 
importance of partnerships with respect to bringing about compliance with, and ultimately 
enforcing, a final rule.  Comments urged the agen cy to work in cooperatio n with other federal, 
State, Territorial, tribal and loca l agencies with jurisdiction and e xpertise to ensure a coordinated 394 
 
and uniform approach to enforcement and co mpliance that will improve efficiency and 
effectiveness.  Several comments noted that  governmental testing la boratories should be 
recognized and funding should be provided to States to hire and train auditors.   
We agree that partnerships will play a crucia l role in bringing the produce industry into 
compliance with a final rule.  As discussed in our overall strategy a bove and reflected in 
proposed 112.193, FDA intends to work with State,  Territorial, tribal, a nd local partners to 
develop the education and enfo rcement tools and training prog rams needed to facilitate 
consistent inspection and regulator y activities associated with the requirements of a final produce 
safety rule.  Education and outreach through mechanisms like PSA and other sources of 
information that are familiar to the produce fa rming community (such as Cooperative Extension, 
land grant universities, and trade associations ) are the foundation of our intended compliance 
strategy.  We also plan to work with these a nd other stakeholders to  develop a network of 
institutions that can provide technical assistan ce to the farming community, especially small and 
very small farms, as they endeavor to comply with the provisions of a final rule.  Of course, 
although much of our initial effort will be fo cused on education and outreach, we will also 
inspect farms on a targeted basis for compliance w ith a final produce safety rule.  Partnerships 
will play an important role w ith regard to inspections as well.  FDA intends to work 
collaboratively with our federal, State, Territori al, tribal, and local regul atory partners to use 
available inspection resources to conduct risk-bas ed inspections of farms for compliance with the 
final regulation.  FDA intends to further facilita te compliance with our final regulation through 
the development and dissemination of guidance on procedures, conditions, and practices that 
farms can implement to reduce the risk of known or reasonably foreseeable hazards.  395 
 
Several comments noted that foreign government s could also play an important role in 
verifying compliance.  Some noted that  global recognition of food safety and food defense 
efforts should be developed.  One country specific ally requested that we  recognize foreign fresh 
produce initiatives as equivalent  oversight of the industry.   
We agree that foreign governments will play  an important part in bringing about 
compliance with a final produce rule  with respect to foreign products.  We have already begun to 
reach out to foreign governments regarding th e requirements of FSMA and will continue to 
provide technical assistance as  we move closer to finaliz ing rules issued under FSMA 
authorities.  There are several pr ovisions of FSMA that directly re late to these partnerships.  
Section 305 of FSMA specifically dir ects us to develop a plan to build the capacity of foreign 
governments with respect to food safety that will  include, among other things , training of foreign 
governments on our requirements, provisions for mu tual recognition of inspection reports, and 
provisions for multilateral acceptance of labor atory methods and testing and detection 
techniques.  Under section 307 of  FSMA, which added section 808 to the FD&C Act [21 U.S.C. 
384d], we are directed to establish a system for the recognition of accreditation bodies that 
accredit third-party auditors to certif y that eligible entities meet ce rtain requirements.  Under that 
section, foreign governments or agencies of fo reign governments, may be accredited as third 
party auditors who could help to  ensure compliance with a final produce safety rule.  Section 303 
of FSMA amended section 801 of the FD&C Act t o, among other things, allow us to designate 
an agency or representative of the forei gn government of the country from which a food 
originated to provide ce rtification or other assu rances that certain foods are in compliance with 
the FD&C Act, if FDA chooses to require such certifications or a ssurances for certa in foods.  We 
are working to implement these provisions of FSMA.  In addition, as set forth in subpart P of this 396 
 
proposed rule, foreign countries may request variances from requi rements proposed in this rule, 
provided they meet certain conditions.  See secti on V.P. of this document for further discussion 
of the process, conditions, and procedures  related to a reques t for variance(s). 
In addition to partnering with other U.S. agencies and foreign governments, several 
comments discussed the strength of industry pr ograms imposed throughout the supply chain and 
urged us to leverage these pr ivate sector efforts.  Some commented on the importance of 
verification of compliance by quali fied and independent third pa rties and recognition of third 
party certification.  These third parties could be  those hired by industr y, including retailers, to 
ensure the safety of produce from their supp liers.  However, some comments identified 
duplicative audits and excessive do cumentation as problematic, part icularly for small growers.  
Other comments recognized that importers can play  an important role in verifying compliance 
with a final produce safety rule and safety of imported produce. 
We agree that we should leverage the effo rts of private supply chain management to 
further compliance with a final rule in this area.   See discussion of our overall enforcement and 
compliance strategy immediately above.  We also agree that importers w ill play an important 
role in ensuring the safety of produce grown in ot her countries and shipped to the United States.  
Under section 301 of FSMA, importers will have to verify that imported covered produce is 
produced in compliance with processes and proce dures that provide the same level of public 
health protection as those required u nder section 419 of the FD&C Act.   
Other comments noted that compliance with pr oduce safety requirements should be tiered 
to reflect farm size, market requirements and risk. One comment noted that there should be 
dedicated inspectors for identified groups th at may need additional assistance.    397 
 
 We agree that we should prioritize our complia nce and enforcement efforts.  As discussed 
above, we will be targeting our education efforts to the smaller businesses that may not be as 
familiar with our requirements as some of the larger farms.  We also propose to give small and very small businesses extra time to comply with th e final rule, as discusse d in section IV.K of 
this document.  With respect to inspections, they  will, of necessity, be targeted to those farms 
that present the greatest risk  based, in part, on their associ ation with past outbreaks or 
contamination events and the risk associated with the agricultural practices they apply in the growing, harvesting, packing, and ho lding of covered produce.   
A few comments mentioned that research can play an important part in bringing about 
industry compliance.  Some noted that foodborne il lness outbreak investigations needed to be 
improved and used as educational opportunities to support food safety research.  They noted that 
better investigative methods should be devel oped to help reveal possible sources of 
contamination.  FDA agrees, as reflected in the recent establishment of the Coordinated 
Outbreak Response and Evaluation (CORE) Ne twork, which is a permanent cadre of FDA 
experts whose full time responsibility is to en hance outbreak detection, response, and follow up 
investigations to inform future prevention effort s.  CORE will work with CDC, state and local 
partners, and the food industry to  investigate root causes of ma jor outbreaks and share findings 
with the food safety community.  
Comments also noted that a permanent in stitutional part of government should be 
developed to coordinate resear ch, information, responses to, a nd control measures for, human 
pathogens and their evolution in the environmen t, including the farm environment, animal 
production, the industrial and commer cial environment and the medical (healthcare) system.  As 398 
 
discussed previously, we are pursu ing regulatory science and research  activities in collaboration 
with various partners.  See section II.E. of this document for further information. 
6. Proposed Requirements 
Proposed § 112.191 states that the criteria a nd definitions in this part apply in 
determining whether a food is adulterated (1) w ithin the meaning of s ection 402(a)(3) of the 
Federal Food, Drug, and Cosmetic Act in that the food has been grown, harvested, packed, or 
held under such conditions that it is unfit for food ; or (2) within the mean ing of section 402(a)(4) 
of the Federal Food, Drug, and Cosmetic Act in that  the food has been prep ared, packed, or held 
under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to  health. The criteria and definitio ns in this part also apply in 
determining whether a food is in violation of section 361 of the Public Health Service Act (42 
U.S.C. 264). As discussed in section III of this document , FDA proposes these regulations under the FD&C 
Act as amended by FSMA, and the Public Health Service Act (PHS Act).  We note that section 
419(c)(1)(A) of the FD&C Act provides that FDA shall establish in this rulemaking “procedures, 
processes, and practices that th e Secretary determines to be re asonably necessary … to provide 
reasonable assurances that the produce is not ad ulterated under section 402 [of the FD&C Act]” 
and that similar references to  preventing adulteration under sec tion 402 of the FD&C Act also 
appear in section 419(c)(1)(F), (c )(2)(A), (c)(2)(C), and (c)(2)(D).  In sections V.A. through V.O. 
of this document, we explain how the proposed provisions are necessary to protect against contamination with hazards that may adulterate  food.  We tentatively conclude that the link 
between the proposed provisions and the potential for adulterati on provides a basis for applying 
the criteria and definitions in proposed part 112 in determining whether, under particular 399 
 
circumstances, a food is adultera ted under section 402(a)(3 ) or (a)(4) or in violation of section 
361 of the PHS Act.  We also not e 402(a)(4) of the FD &C Act provides that food is adulterated 
if it has been “prepared, packed, or held unde r insanitary conditions” whereby either of the 
proscribed results may occur.  “Prepared, packed, or held” incl udes growing, harvesting, 
packing, and holding.  The common meaning of “p repare,” as represented by the dictionary 
definition is, in relevant part, “to make ready beforehand for some  purpose, use, or activity… to 
put together” (Ref. 264).  Growing and harvesting are operati ons that make food ready for use as 
food.  In addition, growing and harvesting at times involve holding of food.   
Section 105(c) of FSMA amends section 301 of the FD&C Act (21 U.S.C. 331) by 
adding a new section - (vv) - to th e list of acts and the causing thereof that are prohibited.  Under 
section 301(vv), the following act, and the causing th ereof, is prohibited:   “[t]he failure to 
comply with the requirements under section 419 [of the FD&C Act].”  To clearly communicate 
that failure to comply with regulations estab lished under section 419 is a prohibited act, proposed 
§ 112.192 would establish that the fa ilure to comply with the requirements of part 112, issued 
under section 419 of the Federal Food, Drug, and Cosm etic Act, is a prohibited act under section 
301(vv) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 331(vv)).     
Proposed § 112.193 provides that under Secti on 419(b)(2)(A) of the FD&C Act, FDA 
coordinates education and enforcem ent activities by State, Territorial , tribal, and local officials.  
As described above, we plan to work closely with State, Territorial, tribal , and local partners to 
develop the education and enfo rcement tools and training prog rams needed to facilitate 
consistent inspection and regulat ory activities associated with the requirements proposed in 
subparts A through O. 
 400 
 
R. Subpart R – Withdrawal of Qualified Exemption 
As proposed, subpart R establishes the proced ures that would govern the circumstances 
and process whereby we may issue an order with drawing a qualified exem ption applicable to a 
farm in accordance with the requirements of § 112.5.  Specifically, proposed § 112.201 lists the circumstances under which FDA can withdraw a qua lified exemption applicable to a farm, while 
§§ 112.202 and 112.203 specify the procedure and information that FDA would include in an order to withdraw such qua lified exemption.  In addition, proposed §§ 112.204 through 112.207 
provide for a process whereby you may submit a writ ten appeal (which may include a request for 
a hearing) of an order to wit hdraw a qualified exemption applicab le to your farm, and proposed 
§§ 112.208 through 112.211 provide a procedure for app eals, hearings, and decisions on appeals 
and hearings.  
1. Requirements of Section 419 of the FD&C Act 
Section 419(f)(3)(A) of the FD&C Ac t specifies that, “[i]n the event of an active investigation of 
a foodborne illness outbreak that is directly li nked to a farm subject to an exemption under 
[section 419(f) of the FD&C Act], or  if the Secretary determines that it is necessary to protect the 
public health and prevent or mitigate a f oodborne illness outbreak based on conduct or 
conditions associated with a farm that are mate rial to the safety of the food produced or 
harvested at such farm, the Secretary may withdr aw the exemption provid ed to such farm under 
[section 419(f) of the FD&C Act] .”  Section 419 does not expressl y prescribe the procedures for 
withdrawing a qualified exemption provided to a farm under section 419(f).  We tentatively 
conclude that it is appropriate to be transparent about the proc ess we would use to withdraw a 
qualified exemption and that we should in clude the process in the proposed rule. 
2. Proposed Requirements 401 
 
 a. Circumstances for withdrawal 
Proposed § 112.201 would establish the circum stances under which FDA can withdraw 
an exemption applicable to a farm.  Consistent  with Section 419(f)(3)(A ) of the FD&C Act, it 
states that we may withdraw your qu alified exemption under proposed § 112.5: 
(1) In the event of an active inve stigation of a foodborne illness outbreak that is directly linked to 
your farm (proposed § 112.201(a)); or  
(2) If we determine that it is necessary to pr otect the public health and prevent or mitigate a 
foodborne illness outbreak based on conduct or cond itions associated with your farm that are 
material to the safety of the food that woul d otherwise be covered produce grown, harvested, 
packed or held at your farm (proposed § 112.201(b)). Proposed § 112.201(a) would implement the statut ory language of section 419(f)(3)(A) of the 
FD&C Act.  An outbreak of foodbor ne illness is the occu rrence of two or more  cases of a similar 
illness resulting from the ingestion of a common food.  Food can become contaminated at many 
different steps in the farm-to-table continuum: on the farm; in packing, 
manufacturing/processing, or distribution faci lities; during storage or transit; at retail 
establishments; in restaurants; a nd in the home.  When foodborne illness is associated with food, 
an investigation may enable us to directly li nk the illness to the farm  that grew, harvested, 
packed, and/or held the food.     Proposed § 112.201(b) would also implement the st atutory language of s ection 419(f)(3)(A) of 
the FD&C Act, which provides that FDA may w ithdraw a qualified exemption available to a 
farm under section 419(f) “if the Secretary determin es that it is necessary to protect the public 
health and prevent or mitigate a foodborne illness outbreak based on conduct or conditions associated with a farm that are material to the safety of the food produced or harvested at such 402 
 
farm.”  We tentatively conclude that the food to which this sta ndard applies is food that would 
otherwise be covered produce, because that is th e food that would be subject to this proposed 
rule if a qualified exemption is withdrawn.  We al so tentatively conclude th at it is reasonable to 
interpret the word “produced” in this standard to refer to the activities within the farm definition 
other than harvesting, because this proposed rule would apply only to activ ities within the farm 
definition and the standard al ready uses the word “harvested.”  Thus, proposed § 112.201(b) 
would provide that FDA may withdraw the qualif ied exemption applicable to a farm under 
proposed § 112.5 if FDA determines that it is necessa ry to protect the pub lic health and prevent 
or mitigate a foodborne illness outbreak based on conduct or conditions associated with a farm 
that are material to the safety of the food that would otherwise be covered produce grown, 
harvested, packed, or held at such farm.  As  an example, we may receive reports to the 
Reportable Food Registry under section 417 of th e FD&C Act about contamination of a food, 
and the reports may lead us to investigate a farm  that grew, harvested, packed or held the food.  
If our investigation finds conduct or  conditions associated with the farm that are material to the 
safety of the food that would otherwise be covered produce subject to  proposed subparts B 
through O of this rule (for example, conduct or c onditions that likely led to the contamination of 
the food), we would consider withdrawing the qu alified exemption appli cable to the farm under 
proposed § 112.5 if doing so would be necessary to  protect the public health and prevent or 
mitigate a foodborne illness outbreak.  Likewise, if during a routine inspection of a farm to 
which the qualified exemption in proposed § 112.5 applies, we discover conditions and practices 
that are likely to lead to c ontamination of food that would ot herwise be covered produce with 
microorganisms of public health significance, we would consid er withdrawing the qualified 403 
 
exemption provided to the fac ility under proposed § 112.5 if doing so would be necessary to 
protect the public health and prevent or  mitigate a foodborne illness outbreak.   
b. Procedure for issuance of withdrawal order Proposed § 112.202(a) would provide  that, if FDA determines that a qualified exemption 
applicable to a farm under § 112.5 should be wi thdrawn, any officer or qualified employee of 
FDA may issue an order to withdraw the exempti on. We intend to create and maintain a written 
record of a determination that the withdrawal of  an exemption is warranted and to include the 
basis for the determination in the written reco rd.  Proposed § 112.202(b) w ould require that an 
FDA District Director  in whose district the farm is located (or, in the case of a foreign farm, the 
Director of the Office of Complia nce in the Center for Food Safety and Applied Nutrition), or an 
FDA official senior to such Dire ctor, must approve an order to w ithdraw the exemption as part of 
the withdrawal determination procedure before the order is issued.  A Regional Food and Drug 
Director is an example of an FDA official seni or to a District Direct or.  The Deputy Directors 
and Director of the Center for Food Safety a nd Applied Nutrition are examples of an FDA 
official senior to the Direct or of the Office of Compliance.   Requiring prior approval of a 
withdrawal order by a District Di rector or an FDA official seni or to a District Director is 
consistent with the approval requirement for a detention order in part 1, subpart K 
(Administrative Deten tion of Food for Human or Animal  Consumption).  Requiring prior 
approval of a withdrawal order by the Director of the Office of  Compliance in the Center for 
Food Safety and Applied Nutrition is consistent with current FDA practices when dealing with 
foreign firms.  Proposed § 112.202(c) would require  that FDA issue an order to withdraw the 
exemption to the owner, operator, or  agent in charge of the farm.  We tentatively conclude that it 
would be appropriate for FDA to issue an exemp tion withdrawal order to any of these persons.  404 
 
Proposed § 112.202(d) would require that FDA issue an order to withdraw the exemption in 
writing, signed and dated by the officer or qualifie d employee of FDA who is issuing the order.  
c. Information included in FDA’s withdrawal order Proposed § 112.203(a) through (h) would require th at an order to withdraw a qualified 
exemption applicable to a farm under § 112.5 include the following information: 
 (a) The date of the or der (proposed § 112.203(a)); 
 (b) The name, address and location of the covered farm (proposed § 112.203(b)); 
 (c) A brief, general statement of the reasons  for the order, including information relevant 
to: 
(1) An active investigation of a foodborne illness outbreak that  is directly linked to the 
farm; or  
(2) Conduct or conditions associat ed with a farm that are material to the safety of the 
food that would otherwise be covered produce grow n, harvested, packed and held at such farm 
(proposed § 112.203(c));  
(d) A statement that the farm must comply w ith subpart B through subpart O of this part 
on the date that is 60 calendar days after the date of the orde r (proposed § 112.203(d)); 
(e) The text of section 419(f)  of the Federal Food, Drug, and Cosmetic Act and of subpart 
R of the rule (proposed § 112.203(e)); 
(f) A statement that any informal hearing on an  appeal of the order must be conducted as 
a regulatory hearing under part 16 (21 CFR Part  16), with certain exceptions described in 
proposed § 112.208 (proposed § 112.203(f)); 
(g) The mailing address, telephone number, e-ma il address, and facsimile number of the 
FDA district office and the name of the FDA Dist rict Director in whose district the farm is 405 
 
located (or, in the case of a foreign farm, the sa me information for the Director of the Office of 
Compliance in the Center for Food Safety and Applied Nutrition); (proposed § 112.203(g)); and  
(h) The name and the title of the FDA repr esentative who approved the order (proposed § 
112.203(h)). FDA tentatively concludes that the requirement s that we propose in § 112.203 would provide the 
owner, operator, or agent in charge of a farm subj ect to a withdrawal with adequate notice of the 
basis for our determination to withdraw the ex emption and of their opportunity to appeal our 
determination and to request an informal hear ing.  The proposed notification procedures are 
similar to and consistent with  the notification requirements in other regulations involving 
administrative action, such as administrativ e detention of food under § 1.393, orders for 
diversion or destruction of  shell eggs under the PHS Act under § 118.12(a)(i), and with 
procedures for an informal hearing in part 16. We seek comments on the proposed process for 
withdrawal of a qualified exemption. 
d. Requirements when a wit hdrawal order is issued 
Proposed § 112.204 would require that the owner, operator, or agent in charge of a farm that 
receives an order to withdraw  an exemption applicable to that farm under § 112.5 either (a) 
comply with applicable requirements of this part within 60 calendar days of the date of the order 
or, if operations have ceased and will not resu me within 60 calendar days, before the beginning 
of operations in the next growing season; or (b) appeal the order within 10 calendar days of the 
date of the order in accordance with the requirements of § 112.206.  We tentatively conclude that 
either of the two circumstances that could result in our determination that an exemption should 
be withdrawn (as described in proposed § 112.201) warrant prompt compliance with the rule in 
the interest of public he alth.  We tentatively conclude that ten calendar days for the submission 406 
 
of an appeal from the date of the receipt of a wi thdrawal order is appropria te for purposes of the 
efficient adjudication of the appeal of a wit hdrawal order and would provide reasonable due 
process that comes to closure sufficiently in advan ce of the effective date of the order to provide 
an opportunity for the farm to come into compliance if we deny the appeal. e. Procedure for appealing a withdrawal orde r (including requests for informal hearing) 
Proposed § 112.205(a) would establis h that submission of an app eal, including submission of a 
request for an informal heari ng, will not delay or stay any administrative action, including 
enforcement action by FDA, unless the Commi ssioner of Food and Drugs, as a matter of 
discretion, determines that delay or a stay is in  the public interest. For example, the submission 
of an appeal of a withdrawal order with a requ est for an informal hearing would not prevent FDA 
from simultaneously detaining food from the farm under section 304(h) of the FD&C Act, 
seeking seizure of food from the farm under sect ion 304(a) of the FD&C Act, or seeking or 
enforcing an injunction unde r section 302 of the FD&C Ac t.  Proposed § 112.205(b) would 
require that, if the owner, operato r, or agent in charge of the farm appeals the order, and FDA 
confirms the order, the owner, operator, or ag ent in charge of the farm must comply with 
applicable requirements of this part within 60 calendar days of the date of the order or, if 
operations have ceased and will not resume within 60 calendar days, before the beginning of operations in the next growing season.  Pr oposed § 112.205(b) would make clear that the 60 
calendar day time frame for compliance applies re gardless of whether the owner, operator, or 
agent in charge of a farm requests, and FDA grants, a hearing.  As already discussed, FDA 
tentatively concludes that the ci rcumstances that lead to a determination that an exemption 
should be withdrawn warrant prompt complia nce in the interest  of public health. 407 
 
Proposed § 112.206(a) would require that, to appeal  an order to withdraw a qualified exemption 
applicable to a farm under § 112.5, the owner, operato r, or agent in charge of the farm must: (1) 
submit the appeal in writing to the FDA District Dir ector in whose district the farm is located (or, 
in the case of a foreign farm, to the Director of the Office of Compliance in the Center for Food 
Safety and Applied Nutrition), at the mailing address, e-mail address, or facsimile number 
identified in the order within 10 calendar days of the date of the orde r; and (2) respond with 
particularity to the facts a nd issues contained in the order, including any supporting 
documentation upon which the owner, operator or agen t in charge of the fa rm relies.  Allowing 
the owner, operator, or agent in charge of th e farm to submit an appeal in person, by mail, e-
mail, or fax would provide for flexibility as well as speed.  For example, submitting in person would give the owner, operator, or agent in char ge direct knowledge that the request for appeal 
had been delivered and received.  E-mail and fax are instantaneous, and overnight mail delivery services are readily available to  those who choose to use them; however, the ten day time frame 
for appeal of the order would not require the use of overnight mail de livery.  For clarity, 
proposed § 112.206(a)(1) would repeat  the 10 calendar day time fram e that would be established 
in proposed § 112.204 and would not establish any ne w requirement.  Any appeal would need to 
be written in order for FDA to evaluate the basi s for the appeal.  We are proposing that a written 
appeal would need to address with particularity a ll of the issues raised in the withdrawal order 
and include all suppo rting documentation so that we would be  able to issue a final determination 
as to the disposition of the appeal solely on the basis of the materials submitted as part of the written appeal.   Proposed § 112.206(b) would provide that, in a written appeal of  the order withdrawing an 
exemption provided under § 112.5, the owner, operato r, or agent in charge of the farm may 408 
 
include a written request for an informal hearing as provided in § 112.207.  Requesting an 
informal hearing does not mean that a hearing will be held, because we may deny the request 
(see discussion of proposed § 112.207(b) below).  Howe ver, if the owner, operator, or agent in 
charge of the farm does not request an inform al hearing at the time the written appeal is 
submitted, the owner, operator, or agent in charge of the farm will not be entitled to an informal 
hearing.  Instead, FDA will make a final decision  based on the written appeal and its supporting 
materials. Proposed § 112.207(a)(1) would provide that, if the ow ner, operator, or agent in charge of the 
farm appeals the order, the owner, operator, or  agent in charge of th e farm may request an 
informal hearing.  Proposed § 112.207(a)(1) would re state an option that would be included in 
proposed § 112.206(b) to highlight the opportunity to  request an informal hearing.  Proposed § 
112.207(a)(2) would require that, if the owner, operato r, or agent in charge of the farm appeals 
the order, the owner, operator, or agent in charge of the farm  must submit any request for an 
informal hearing together with its written appeal submitted in accordance with § 112.206 within 
10 calendar days of the date of the order.  We tentatively conclude that  requiring submission of a 
request for an informal hearing in writing at the time that the owne r, operator, or agent in charge 
of the farm would be required to submit a written appeal is appropriate for purposes of the 
efficient adjudication of the appeal of a wit hdrawal order and would provide reasonable due 
process that would come to closure sufficiently in  advance of the effective date of the order to 
provide an opportunity for the farm to come into compliance if we deny the appeal.  Proposed § 112.207(b) would establish that a  request for an informal hearing may be denied, in 
whole or in part, if the presid ing officer determines that no ge nuine and substantial issue of 
material fact has been raised by the materi al submitted.  Proposed § 112.207(b) would also 409 
 
provide that if the presiding offi cer determines that a hearing is not justified, written notice of the 
determination will be given to the owner, operator,  or agent in charge of the farm explaining the 
reason for the denial.  Under proposed § 112.206(a) , a written appeal w ould be required to 
respond with particularity to the facts and issues  contained in the with drawal order, including 
any supporting documentation upon which the owner, operator or agent in charge of the farm 
relies.  If the materials submitted do not directly address the facts and issues contained in the withdrawal order in a manner that  suggests that there is a genuine dispute regarding the material 
facts contained in the order, the presiding officer  may determine that an informal hearing is not 
warranted.  The presiding officer may include written notice of the determination that a hearing 
is not justified as part of the final decision on the appeal. 
f. Procedure for appeals (i ncluding informal hearings) 
Proposed § 112.208(a) would establish th at, if the owner, operator or agent in charge of the farm 
requests an informal hearing, and FDA grants th e request, the hearing wi ll be held within 10 
calendar days after the date the a ppeal is filed or, if applicable , within a time frame agreed upon 
in writing by the owner, operator, or agent in charge of the farm and FDA.  We tentatively 
conclude that, if we grant a request for an informal hearing, holdi ng the hearing within 10 
calendar days, or within an alte rnative time frame as agreed upon in writing, is appropriate for 
purposes of the efficient adjudication of the a ppeal of a withdrawal order and would provide 
reasonable due process that would co me to closure sufficiently in advance of the effective date of 
the order to provide an opportunity for the farm to  come into compliance if we deny the appeal.   
Proposed 112.208(b) would establis h that the presiding officer may require that a hearing 
conducted under this subpart be completed within 1 calendar day, as appropriate.  We tentatively 
conclude that, if we grant a request for an in formal hearing, limiting the time for the hearing 410 
 
itself to be completed within 1 calendar day is appropriate for purpos es of the efficient 
adjudication of the appeal of a withdrawal orde r and would provide reasonable due process that 
would come to closure sufficiently in advance of the effective date of the order to provide an 
opportunity for the farm to come into compliance if we deny the appeal. Proposed § 112.208(c)(1) through (7) would establish that, if the owner, operator or agent in 
charge of the farm requests an informal heari ng, and FDA grants the request, FDA must conduct 
the hearing in accordance with part 16, except that:  (1) The order withdrawing an exempti on under § 112.5, rather th an the notice under § 
16.22(a), provides notice of opportunity for a hear ing under this section and is part of the 
administrative record of the regulatory h earing under § 16.80(a) of this chapter.  
 (2) A request for a hearing under this subpart  must be addressed to the FDA District 
Director (or, in the case of a foreign farm, the Director of the Office of Compliance in the Center 
for Food Safety and Applied Nutrition) as prov ided in the order withdrawing an exemption.  
 (3) Section 112.209, rather than § 16.42(a), de scribes the FDA employees who preside at 
hearings under this subpart.    (4) Section 16.60(e) and (f) of th is chapter does not apply to a hearing under this subpart.  
The presiding officer must prepar e a written report of the heari ng. All written material presented 
at the hearing will be attached to the report. Th e presiding officer must include as part of the 
report of the hearing a finding on the credibility of witnesses (o ther than expert witnesses) 
whenever credibility is a material issue, and must include a proposed d ecision, with a statement 
of reasons. The hearing particip ant 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.   411 
 
 (5) Section 16.80(a)(4) of this  chapter does not apply to a regulatory hearing under this 
subpart.  The presiding officer’s report of th e hearing and any comment s 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, und er § 16.119 of this chapter to petition the 
Commissioner of Food and Drugs for reconsiderati on 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 purs uant to regulation in 
accordance with part 16, except that § 16.95(b) does  not apply to a hearing under this subpart.  
With respect to a regulatory h earing under this subpart , the administrative r ecord of the hearing 
specified in §§ 16.80(a)(1), (a)(2), (a)(3), and (a)(5), and 112.208(c)(5) constitutes the exclusive 
record for the presiding officer’s  final decision.  For purposes of  judicial review under § 10.45 of 
this chapter, the record of the administrative proc eeding consists of the record of the hearing and 
the presiding officer’s final decision. 
Under § 16.1(b), the procedures in part 16 apply when a regulation provides a person with an 
opportunity for a hearing on a regulatory action u nder part 16.  Section 419 of the FD&C Act 
does not expressly provide for a hearing if circum stances lead FDA to determine that a qualified 
exemption provided to a farm under proposed § 112.5 should be withdrawn.   However, we 
tentatively conclude as a matter of agency discretion that providi ng an opportunity for a hearing 
by regulation in this subpart of the proposed ru le would provide appropr iate process to the 
owner, operator, or agent in charge of a farm  subject to withdrawal of the farm’s qualified 
exemption.  We also tentatively conclude that th e modified part 16 proced ures contained in this 
proposed rule would provide the owner, operator, or agent in charge of a farm subject to a 412 
 
withdrawal order sufficient fa irness and due process while en abling FDA to expeditiously 
adjudicate an appeal of a wit hdrawal order for which an informal hearing has been granted. We 
seek comment on this proposed process.  Section 16.119 provides that, after an y final administrative action that  is the subject of a hearing 
under part 16, any party may petition the Commissione r for reconsideration of  any part or all of 
the decision or action under § 10.33 or may petition for a stay of the decision or action under § 
10.35.  Proposed § 112.208(c)(6) would specify that these procedures for reconsideration and 
stay would not apply to the process of w ithdrawing a qualified exemption provided under 
proposed § 112.5.  The circumstances that may l ead FDA to withdraw a qualified exemption 
include an active investigation of a foodborne illness outbreak that is  directly linked to a farm, or 
our determination that it is necessary to prot ect the public health and prevent or mitigate a 
foodborne illness outbreak based on conduct or c onditions associated with a farm that are 
material to the safety of the food that woul d otherwise be covered produce grown, harvested, 
packed, or held at such farm.  Such circumst ances require prompt action.  Under § 16.120, a farm 
that disagrees with FDA’s decision to withdr aw an exemption provided under § 112.5 has an 
opportunity for judicial review in accordance with § 10.45. g. Presiding officer Proposed § 112.209 would require that the presiding officer for an appeal, and for an informal 
hearing, must be an FDA Regional Food and Drug Dir ector or another FDA of ficial senior to an 
FDA District Direct or.  Under § 16.42(b), an officer presidin g over an informal hearing is to be 
free from bias or prejudice and may not have particip ated in the investigation or action that is the 
subject of the hearing or be subordinate to a person, other than the Commissioner, who has 
participated in such investigation or action.  An order for the wit hdrawal of a qualified 413 
 
exemption applicable to a farm must be approved by a District Director or an  official senior to a 
District Director.  It is, therefor e, necessary that appeals of a d ecision to issue a withdrawal order 
should be handled by persons in positions senior to the District Direct ors. The Regional Food 
and Drug Director is such a pers on and could be from the same re gion where the farm is located, 
provided that the Regional Food a nd Drug Director did not particip ate in the determination that 
an exemption should be withdrawn and is otherwise free from bias  or prejudice.  Alternatively, 
the Regional Food and Drug Director  could be from a different re gion than the region where the 
farm is located, for example in the event the Regional Food and Drug Dir ector for the region in 
which the farm is located is the FDA official who approved the withdrawal  order.  Any Office 
Director of FDA’s Office of Re gulatory Affairs could preside at  a hearing, provided that the 
Office Director did not participat e in the determination that an  exemption should be withdrawn 
and is otherwise free from bias or prejudice. h. Decisions on appeals (inc luding informal hearings) 
Proposed § 112.210(a) would require th at, if the owner, operator, or agent in charge of a farm 
appeals the order without requestin g a hearing, the presiding officer  must issue a written report 
that includes a final decision c onfirming or revoking the withdraw al by the tenth calendar day 
after the appeal is filed.  U nder proposed § 112.201, FDA would issu e a withdrawal order either 
in the event of an active investigation of a foodbor ne illness outbreak that is directly linked to a 
farm or if we determine that an  exemption withdrawal is necessary to protect the public health 
and prevent or mitigate a foodborne illness outbre ak based on conduct or conditions associated 
with a farm that are material to the safety of  the food that would otherwise be covered produce 
grown, harvested, packed, or held by the farm.  We tentatively c onclude that we will need 10 
calendar days to review the written appeal and the materials submitted with the written appeal, 414 
 
and that a final decision confir ming or revoking a withdrawal orde r should be issued as quickly 
as possible in the interest of the public health and to provide reasonable due process that would 
come to closure sufficiently in advance of th e effective date of th e order to provide an 
opportunity for the farm to come into compliance if we deny the appeal.  Proposed § 112.210(b)(1) would require th at, if the owner, operator, or  agent in charge of a farm 
appeals the order and requests an informal hearin g and, if FDA grants the request for a hearing 
and the hearing is held, the presiding officer must provide a 2 calendar day opportunity for the 
hearing participants to review and submit co mments on the report of  the hearing under § 
112.208(c)(4), and must issue a final decision within  the 10-calendar day pe riod after the hearing 
is held.  We tentatively conclude  that it is appropriate to grant the owner, operator, or agent in 
charge of a farm subject to a withdrawal order the opportunity to review and submit comments to 
the presiding officer’s report because the report is part of the record of a final agency action (see 
discussion of proposed § 112.211(d)) th at is not subject to furthe r reconsideration by FDA. The 
presiding officer would have disc retion to determine whether to re vise the report of the hearing 
in light of any comments that might be submitted by any of the hearing participants. Proposed § 112.210(b)(2) would require th at, if the owner, operator, or  agent in charge of a farm 
appeals the order and requests an informal hearin g and if FDA denies the request for a hearing, 
the presiding officer must issue a final deci sion on the appeal c onfirming or revoking the 
withdrawal within 10 calendar days after the date the appeal is filed.  We tentatively conclude 
that ten calendar days for the presiding officer to issue a fi nal decision is appropriate for 
purposes of the efficient adjudication of the a ppeal of a withdrawal order, would provide 
reasonable due process that would co me to closure sufficiently in advance of the effective date of 415 
 
the order to provide an opportunity for the farm to come into compliance if we deny the appeal, 
and is in the interest of public health. i. Revocation of withdrawal order Proposed § 112.211(a) through (c) would establish that an order to withdraw a qualified 
exemption applicable to a farm under § 112.5 is revoked if: (a) The owner, operator, or agent in charge of the farm appeals th e order and requests an 
informal hearing, FDA grants the request for an informal hearing, and the presiding officer does 
not confirm the order within the 10 calendar days after the heari ng, or issues a decision revoking 
the order within that time (proposed § 112.211(a)); or  (b) The owner, operator, or agent in charge of the farm appeals th e order and requests an 
informal hearing, FDA denies the request for an  informal hearing, and FDA does not confirm the 
order within the 10 calendar days  after the appeal is filed, or issues a decision revoking the order 
within that time (proposed § 112.211(b)); or 
 (c) The owner, operator, or agent in char ge of the farm app eals the order without 
requesting an informal hearing, and FDA does not confirm the orde r within the 10 calendar days 
after the appeal is filed, or issues a decision revoking the order within that time (proposed § 
112.211(c)). We tentatively conclude that an order to wit hdraw an exemption may be revoked in one of two 
manners.  First, we are proposing that the FDA officer responsible for adjudicating the appeal 
and presiding over a hearing, if one is grante d, may expressly issue a written decision revoking 
the order within the specified 10 calendar day ti me frame.  Second, we are proposing that the 
failure of the FDA officer responsible for adju dicating an appeal to issue a final decision 
expressly confirming the order within the specif ied time frames will also  serve to revoke the 416 
 
order.  We tentatively conclude  that fairness would warrant the revocation of a withdrawal order 
if FDA is unable to meet the proposed d eadlines for expressly confirming an order. 
Proposed § 112.211(d) would establis h that confirmation of a wit hdrawal order by the presiding 
officer is considered a final agency action for purposes of section 702 of  title 5 of the United 
States Code (5 U.S.C. 702).  A confirmation of an order withdrawing an exemption therefore 
would be reviewable by the courts under sec tion 702 of title 5 and in accordance with § 10.45 
(21 CFR § 10.45).   
3. Conforming Amendment to 21 CFR Part 16 
 We propose to amend § 16.1(b)(2) to incl ude 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 hear ings are available. 417 
 
VI. Preliminary Regulatory Impact Analysis 
A. Overview  
 FDA has examined the impacts of th is proposed rule under Executive Order 12866, 
Executive Order 13563, the Regulatory Flexibilit y Act (5 U.S.C. 601-612), and the Unfunded 
Mandates Reform Act of 1995 (Public Law 104-4).  Executive Orders 12866 and 13563 direct agencies to assess all costs and be nefits of available re gulatory alternatives  and, when regulation 
is necessary, to select regulatory approaches that maximize net benefits (including potential 
economic, environmental, public health and safe ty, and other advantages; distributive impacts; 
and equity).  FDA has developed a preliminary re gulatory impact analysis (PRIA) that presents 
the benefits and costs of this proposed rule (Ref. 265).  FDA belie ves that the proposed rule will 
be an economically significan t regulatory action as defined by Executive Order 12866.  FDA 
requests comments on the PRIA. 
B. Regulatory Flexibility Act
 
 The Regulatory Flexibility Act requires agenci es to analyze regulatory options that would 
minimize any significant impact of a rule on sma ll entities.  Because many small businesses will 
need to implement a number of new provisions, FDA acknowledges that th e final rules resulting 
from this proposed rule will have a significant economic impact on a substantial number of small 
entities. 
C. Small Business Regulatory Enforcement Fairness Act of 1996  
 The Small Business Regulatory Enforcement Fairness Act of 1996 (Public Law 104-121) defines a major rule for the purpose of congression al review as having caused or being likely to 
cause one or more of the following: An annua l effect on the economy of  $100 million or more; a 
major increase in costs or prices; signifi cant adverse effects on competition, employment, 418 
 
productivity, or innovation; or si gnificant adverse eff ects on the ability of United States-based 
enterprises to compete with foreign-based en terprises in domestic or export markets. In 
accordance with the Small Business Regulatory Enforcement Fairness Act, the Office of 
Management and Budget (OMB) has determined that this proposed rule is  a major rule for the 
purpose of congressional review. 
D. Unfunded Mandates Reform Act of 1995  
 Section 202(a) of the Unfunded Mandates Re form 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 Fede ral mandate that may result in the expenditure 
by State, local, and tribal governments, in th e aggregate, or by th e private sector, of 
$100,000,000 or more (adjusted annually for inflation)  in any one year.”  The current threshold 
after adjustment for inflation is $136 million, using the most current (2010) Implicit Price 
Deflator for the Gross Domestic Product.  FDA expects that the proposed rule will result in a 1-
year expenditure that would exceed this amount. 
E. Paperwork Reduction Act of 1995  
 This proposed rule contains information colle ction provisions that ar e subject to review 
by OMB under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501–3520). The collections of 
information in the proposed rule have been s ubmitted to OMB for review under Section 3507(d) 
of the Paperwork Reduction Act of 1995.  FDA i nvites comments on: (1) Whether the proposed 
collection of information is necessary for the pr oper performance of FDA’s functions, including 
whether the information will have practical utilit y; (2) the accuracy of FDA’s estimate of the 
burden of the proposed collection of informati on, including the validity  of the methodology and 
assumptions used; (3) ways to enhance the qualit y, utility, and clarity of the information to be 419 
 
collected; and (4) ways to mini mize the burden of the collection of information on respondents, 
including through the use of auto mated collection techniques, when  appropriate, and other forms 
of information technology.  To ensure that comments on information collection are received, OMB recommends that written comments be faxed to the Office of In formation and Regulatory Affairs, OMB, Attn: 
FDA Desk Officer, FAX: 202-395-7285, or emailed to oira_submission@omb.eop.gov
.  All 
comments should be identified with the title “Standards for the Grow ing, Harvesting, Packing, 
and Holding of Produce for Human Consumption.”  In compliance with the Paperwork Reduction 
Act of 1995 (44 U.S.C. 3407(d)), the Agency ha s submitted the information collection provisions 
of this proposed rule to OMB for review. Th ese requirements will not be effective until FDA 
obtains OMB approval. FDA will publish a notice concerning OMB approval of these requirements in the Federal Register
. 
F. Public Access to the Analyses  
 The analyses that FDA has performed in or der to examine the impacts of this proposed 
rule under Executive Order 12866, Executive Orde r 13563, the Regulatory Flexibility Act (5 
U.S.C. 601-612), the Unfunded Mandates Reform Act of 1995 (Public Law 104-4), and the Paperwork Reduction Act of 1995 (44 U.S.C. 3 501–3520) are available to the public in the 
docket for this proposed  rule (Ref. 265). 
 
VII. Analysis of Environmental Impact  
The agency has prepared a categorical exclusion determination relying upon the 
categorical exclusion at 21 CF R 25.30 (j) and the determination that there are no extraordinary 
circumstances which raise the potential for  this rule to individually or cumulatively have a 420 
 
significant effect on the human environment (Ref. 266).  FDA requests comment on its analysis 
and determination.  As set out in more detail in S ection IX of this document, to the extent there 
are any environmental effects that FDA should take into consideration as it prepares a final rule, 
FDA requests public comment and supporting data  or other information (e.g., studies, data, 
reports).  The agency will evaluate the info rmation and input received in response to this 
proposed rule, including the specif ic questions listed in section IX of this document.  Although 
FDA finds that no EIS is necessary for this pr oposed rule, if in response to comment received, 
FDA prepares an EA or EIS, it will provide notice and an opportunity  for public review and 
comment on any such document.  
VIII. Federalism  
FDA has analyzed this proposed rule in acco rdance with the principles set forth in 
Executive Order 13132.  FDA has determined that the proposed rule, if finalized, would not 
contain policies that would have  substantial direct effects on the States, on the relationship 
between the National Government and the St ates, or on the distri bution of power and 
responsibilities among the various levels of gove rnment.  Accordingly, the agency tentatively 
concludes that the proposed rule does not contain policies that ha ve federalism implications as 
defined in the Executive order a nd, consequently, a federalism su mmary impact statement is not 
required.  
IX.  Comments 
Interested persons may submit to the Division of Dockets Management (see 
ADDRESSES) either electronic or written commen ts regarding this document.  It is only 421 
 
necessary to send one set of comme nts.  It is no longer necessar y to send two copies of mailed 
comments.  Identify comments with the docket numb er found in brackets in the heading of this 
document.  Received comments may be seen in th e Division of Dockets Management between 9 
a.m. and 4 p.m., Monday through Friday. 
Comments on proposed provi sions and related issues  – We seek comment on the need 
for, and appropriateness of, the various provisi ons proposed in this rule and our accompanying 
rationale.  Specifically, we seek  comment on the following issues: 
• Proposed provisions in subpart A, including: 
o proposed §§ 112.1 and 112.2, including the pr oduce that would be covered or not 
covered by the rule; the list of produce that would not be covered by the rule because 
it is rarely consumed raw (including as paragus, bok choy, and cranberries); and the 
proposed exemption for produce that rece ives commercial pro cessing, including the 
types of processing that shoul d qualify for this exemption; 
o proposed definitions in § 112.3(c),  including those of agricultural water, hazard, 
reasonably foreseeable hazard, produce, humus, production batch of sprouts, and yard trimmings; 
o proposed definitions of small and very sma ll businesses in § 112.3(b); as well as the 
proposed exclusion of certain farms from th e scope of this rule based sales in § 
112.4(a); 
o whether and how we should require farms th at meet the criteri a for the qualified 
exemption to establish and maintain documen tation of the basis for their exemption; 
o the feasibility of the labeli ng provisions in proposed 112.6(b) , particularly in the case 
of consolidating produce fr om several farm locations. 422 
 
• Proposed general requirements in § 112.11, incl uding on whether we should establish 
specific standards for any types of hazards that would be covered in proposed § 112.11 
but for which we have not proposed specific st andards in proposed subparts C through O; 
and the proposed allowance in § 112.12 for alte rnatives to certain specified requirements, 
including appropriateness of the list of permitted alternatives.  Are there other proposed provisions for which we should permit alte rnatives and, if so, under what, if any, 
additional or different criteria than  those proposed in § 112.12(b) and (c)? 
• Proposed provisions in subparts C and D dir ected to personnel trai ning, and health and 
hygiene, including the proposed requirements for training on principles of food hygiene 
and food safety, and for the maintenance of  adequate personal cl eanliness and hygienic 
practices when handling covered produce or food-contact surfaces during covered 
activities, including the provi sions relevant to use of gloves and hand sanitizers; 
• Proposed provisions directed to water, includi ng those related to water quality, microbial 
indicators, and testing in §§ 112.41, 112.44, and 112.45; provision related to water 
sourced from public water systems in § 112.45(a); and recordkeeping in § 112.50; specifically:  
o Are the provisions in §§ 112.44 – 112.46 appropr iately tailored to  the risk posed 
by the manner in which the water is used?   
o Are the microbial standards specified in  these provisions appropriate for the 
specified intended uses?  For example, ar e the microbial standards appropriately 
tailored to uses such as direct  application of irrigation water? 423 
 
o Are the provisions related to treatment of water sufficiently flexible to permit 
alternative safe uses of water that does not meet the specified microbial standard 
for its intended use?  
o Is there a need for a provision specifically  related to disinfec tion treatment of re-
circulated or single pass water used during and after harvest? 
o Are there any alternative options no t considered in the proposed rule? 
• Proposed provisions in subpart F directed to soil amendments, including those related to 
status, treatment, application restricti ons, minimum application intervals, and 
recordkeeping (including the re quirement related to documentation such as Certificates of 
Conformance); our focus on biological soil amen dments of animal origin; any alternative 
options that we have not considered in this  proposed rule; and the risk presented by the 
use of biological soil amendments in spr outing and whether that  practice should be 
prohibited;  
• Proposed provisions in subparts I, K, and L, including proposed § 112.81 related to the 
scope of applicability of subpart I, proposed § 112.114 related to dropped produce, and 
proposed § 112.115 related to measures to pr event formation of botulinum toxin; 
specifically: 
o Do you agree with our proposal to apply the proposed provisions in subpart I 
when covered activities take place in an outdoor area or a partially-enclosed 
building where there is a reasonable pr obability of contamination of covered 
produce, and our tentative conclusion that, accordingly, crops that grow 
completely underground would not be s ubject to the proposed provisions of 
subpart I?  424 
 
o With respect to dropped produce, should proposed § 112.114 apply to all 
commodities or should we provide for certa in exceptions (and, if so, under what 
criteria)?  Does proposed § 112.114 appr opriately address produce (such as 
almonds) that is intentio nally dropped to the ground during harvesting and where 
such harvesting does not cause bruising or damage to the produce?  Should produce with peelable skin be excluded?  
o Is proposed § 112.115 a reasonably necessary measure to ensure the safety of 
packaged covered produce?  Are there specif ic types or conditions of modified or 
reduced oxygen packaging methods that may or may not increase the risk of 
formation of botulinum toxin? 
• Proposed provisions specific to  sprouts in subpart M, incl uding treatment of seeds and 
beans; microbial indicators and frequency of environmenta l monitoring; a nd requirement 
to establish and implement a written envi ronmental monitoring plan (§ 112.144(a)) and 
sampling plan for each production batch of sprouts (§ 112.146(a)); as well as whether 
soil-grown sprouts should be subject to th e proposed requirements, and whether and how 
to establish a supplier approval and verifica tion program for seeds and beans used for 
sprouting; 
• Proposed provisions in subpart N, includi ng methods and allowance for alternative 
methods to be used provided they are at least equivalent to the proposed method in 
accuracy, precision, and sensitivity; 
• Proposed requirements related to documentation and records in subpart O, including the 
requirement for a supervisor or responsible pa rty to review certain records, and whether 425 
 
there are any circumstances that would warrant not applying part 11 to records that would 
be required to be kept under part 112; 
• Proposed provisions in subpart P for variances, including rela ted 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; Are there any specific concerns th at we should consider in finalizing the 
procedures and processes for requests fo r variances, as applicable to foreign 
governments?  
• Overall implementation and compliance strate gy and proposed provisi ons in subpart Q, 
including specific strategies we should employ in order to best prioritize our 
implementation of the rule, and coordination of education and enfo rcement activities by 
relevant State, Territorial, tr ibal, and local authorities; and 
• Proposed provisions in subpart R for withdr awal of a qualified exemption, including 
related process and timeframes for acti ons to be taken by FDA or farms.  
• Regarding the scope of the recordkeeping requ irements, are there alte rnative options that 
should be considered? 
• Regarding the handwashing and toilet facility requirements, are our proposals reasonably 
consistent with current model practices or ar e there alternatives not considered in the 
proposed rule? Regulatory approach
 – As discussed in sec tion IV of this document, we have tentatively 
concluded that we should use a regulatory framework based on pract ices, procedures, and 
processes associated with growing, harvesting, pack ing, and holding of all covered produce.  We 
considered and rejected the opti on to develop a framework that (based solely on a history of 426 
 
outbreaks or illnesses associated with the comm odity) would be applicable to individual 
commodities or classes of commoditie s.  Relevant references on the subject of produce safety, as 
well as the QAR, identify common on-farm routes of contaminat ion, such as personnel training, 
health, and hygiene; domestic and wild animals; biological soil amendments of animal origin; 
agricultural water; and equipment and buildings.  Procedures, pro cesses and practices in each of 
these on-farm routes of contamination have the potential to introduce biol ogical hazards into or 
onto any covered produce.  Therefore, we are pr oposing an integrated approach to prescribe 
standards for each of these on-farm routes of cont amination that we have tentatively determined 
are reasonably necessary to prevent the introduction of known or reasonably foreseeable biological hazards and to provide  reasonable assurances that produce is not adulterated under 
section 402 of the FD&C Act.  We also recognize the need for additional standards specifically 
tailored to the growing, harves ting, packing and holding of spr outs, and have proposed minimum 
necessary standards for sprouts.  We seek comme nt on our tentative conclu sions related to this 
issue and the proposed regulatory ap proach described in section IV of the document.  In addition, 
we seek comment on the following: 
• Are there any alternative approaches that we  should consider in establishing science-
based minimum standards for the safe pr oduction and harvesting of produce and to 
minimize the risk of serious adverse health consequences or death?  
• Are there specific commodities or categories of commodities that should be excluded 
from the scope of the rule, based on data rela ted to their relative risk considerations?  
(Note that under our proposed integrated  approach, we propose to exempt certain 
commodities, including a specifi ed list of produce that is rarely consumed raw, and 427 
 
produce that receives commercial processing th at adequately reduces the presence of 
microorganisms of public heal th significance; see secti on V.A.2.a. of this rule.) 
• For example, the QAR ranked certain produce commodities, such as bananas and 
coconuts, as lower risk for illness, in part because such commodities are peeled or shelled 
before consumption in a manner that can be expected not to transfer contamination onto 
the interior, edible portion of the commod ity.  Should such commodities be covered by 
the rule?  Is coverage of these commodities unnecessary?  Should they be covered but 
subject to a less stringent set of requirements?    
• Certain commodities are ranked in the QAR as presenting a relatively lower likelihood of 
exposure, in part because such commodities ha ve fewer potential routes of contamination 
and/or lower potential for contamination.   In addition, some commodities are not known 
to have been associated with outbreaks.  Some commodities (for example, pears, grapefruit, oranges, and lemons) meet both of  these criteria, considering the rankings and 
outbreak data used in the QAR.  Should comm odities that meet both of these criteria be 
covered by the rule? Is coverage of these commodities unnecessary?  Should they be 
covered but subject to a less st ringent set of requirements?  How should the rule address 
the changing nature of outbreak data over time? 
• How should we account for uncovered commoditie s in considering a commodity-specific 
approach that relies on outbreak data?  
• Are there pathogen surveillance data fr om sampling programs focusing on produce 
commodities that have no history of known outbr eaks that would be useful in considering 
a commodity-specific approach?   428 
 
• Can commodity characteristics be used as a basis to consider a commodity-specific 
approach?  While the outbreak data show no consistent pattern that can be matched to 
commodity characteristics such as grow th habit, our QAR shows that produce 
commodities that are ranked as higher risk of  illness and those ranked as lower risk of 
illness do share some of the same characteristics.  A further refinement of our assessment might be helpful in developing a commod ity-specific approach based on commodity 
characteristics.  Considering the qualita tive nature of our assessment, are there 
quantitative data sets available that would enab le a further refinement of our assessment?   
• We seek comment on our tentative conclu sion that produce in both direct market 
channels and other commercial channels are su bject to the same routes of contamination, 
although the number of opportunities for cont amination during packing and holding may 
be greater for produce in other commercial ch annels as compared to produce in direct 
market channels if there are greater numb ers of touch points a nd handlers in these 
channels than there are in direct market channels.   
• We seek comment on our tentative conclu sion that because the statutory qualified 
exemption addresses market channels as a possible risk factor, and because we identified no data that would allow us to otherwise use market channels as a factor in covering and 
regulating produce under this proposed rule , we should not otherwise use market 
channels as a basis of risk categor ization in this proposed rule.    
• Are other data or information available that would be otherw ise useful in considering a 
commodity-specific approach?  
• We seek comment on the proposed effective and compliance dates. 429 
 
• We seek comment on the appropriateness of  the proposed exemptions and partial 
exemptions. Are there additional exempti ons and relevant data to support such 
exemptions that we should consider?  
 Qualitative assessment of risk  – We seek comment on the QAR, conclusions drawn from 
that assessment, and our cons ideration of those conclusions  in developing the proposed 
requirements described in this rule.  We al so request you to submit any data or factual 
information that may help the agency to  conduct, as warranted, a thorough and robust 
quantitative assessment of risk associated wi th produce production and harvesting practices.  
Chemical, physical or radiological hazards  – We seek comment on our tentative conclusion that 
procedures, practices, and processe s, which are proposed in this ru le, are reasonably necessary to 
prevent the introduction of biological hazards only, and on whether, and to what extent, 
chemical, physical or radiological hazards should be covered within the sc ope of a final rule.  
Are there procedures, practices, or processes that  minimize the risk of serious adverse health 
consequences or death and that  are reasonably necessary to pr event the introduction of known or 
reasonably foreseeable chemical, physical or ra diological hazards into produce or to provide 
reasonable assurances that produce is not adul terated under section 402 of the FD&C Act?  
Environmental testing for L. monocytogenes or Listeria spp for covered produce other 
than sprouts  – Proposed § 112.143(a) would require te sting the growing, harvesting, packing, 
and holding environment for sprouts for Listeria  species or L. monocytoge nes; however, we have 
not proposed to require environmenta l testing for other covered produce.  A recent outbreak of 
listeriosis from cantaloupes attributed to insanita ry conditions at a facility that washed, packed, 
cooled and held intact cantaloupes (Ref. 267) raises the question as to whether specific measures 
are necessary to minimize the risk posed by L. monocytogenes  as an environmental pathogen.  430 
 
As discussed in section V.A. of this document, this proposed rule would not apply to off-farm 
facilities such as the facility associated with this cantaloupe outbreak-- such facilities would 
instead be subject to part 110 a nd may be subject to section 418 of the FD&C Act.  However, the 
same risk factors and potential measures for mi nimizing risk are releva nt to both on-farm and 
off-farm produce washing, packing, cooling, a nd holding practices.  Such measures could 
include environmental testing for L. monocytogenes  or Listeria spp. to verify the adequacy of a 
covered farm’s sanitation measures.  Because L. monocytogenes  is a ubiquitous microorganism, 
an intact fruit or vegetable c ould reasonably be expected to occasionally be positive for L. 
monocytogenes .  Many studies have shown the presence of L. monocytogenes  on fresh, intact 
produce, but there is limited epidemiological ev idence associating listeriosis with produce, 
especially with intact fruits and vegetables (Ref. 268.Ref. 269.Ref. 270.Ref. 271.Ref. 272.Ref. 
267). However, this recent outbreak indicates that intact produce can be a vehicle for listeriosis.  
What is not known is the extent to which, and under what circumstances, whole produce 
contaminated with L. monocytogenes  presents a risk to consumers.  The outbreak of listeriosis 
due to contamination of intact cantaloupes appe ars to have occurred due to a combination of 
factors, including pooled water on the floor of th e facility, which was also difficult to clean, 
poorly designed equipment that was previously used for other commodities, no pre-cool step, a 
truck parked near the packing area that had visited a cattle operati on, and possible low level 
contamination from the growing/harvesting operation (Ref. 273). The contribution of 
internalization of the organism and growth with in the fruit is not known.  Moreover, it is not 
known whether all of these circumstan ces are needed for L. monocytogenes  to present a risk on 
produce or whether any one or more would have  been sufficient. We also do not know the 
prevalence of L. monocytogenes  environmental contamination of fruit and vegetable packing 431 
 
facilities (both on- and off-farm), nor do we know the prevalence of L. monocytogenes  on 
produce washed, packed, cooled and stored in such facilities.  We  encourage research to answer 
these questions. We request comment on whether we  should require, in a final rule, any or all 
covered farms that wash and pack produce, or th at only pack produce, to perform environmental 
testing for  L. monocytogenes  or Listeria  spp., and any criteria th at should be employed to 
determine which farms should be subjected to such a requirement. 
Operational assessment, food safety plans  – As discussed in section IV of this document, 
while we recommend that farms conduct an ope rational assessment and develop a food safety 
plan, at this time, we are not proposing to re quire them to do so.  We request comment on 
whether we should require, in a final rule, so me or all covered farms to perform operational 
assessments and/or develop a food safety plan, and any criteria that should be employed to 
determine which farms should be subjected to such a requirement.  
Registration  – We are also requesting comment a bout whether we should require, in a 
final rule, that covered farms, as described in proposed § 112.4(a), register with FDA.  We are 
not aware of a nationwide database of farms, nor  an accumulation of statewide databases, that 
would enable us to identify the names and loca tions of all entities subject to this proposed 
regulation.  This would enable us  to better provide outreach and technical assistance to covered 
entities.  In addition, while insp ection is intended to be only a re latively minor part of our overall 
compliance effort (see section V.Q. of the document for more information on our overall 
strategy), we anticipate perfor ming inspections for enforcemen t purposes.  We would use the 
covered farm registration information to create  a database that we would use to allocate 
inspection resources.  We are also  interested in the existence of  databases that could help us 
identify covered farms in the absence of a re gistration system, and in  the appropriate data 432 
 
elements that should be collected  in a registration system, shoul d we decide to set up such a 
system. 
Environmental issues  – Consistent with § 25.50, FDA is involving the public in 
implementing its NEPA procedures applicable to this proposed rule.  The agency will evaluate 
the information and input received in response to this proposed rule, including the specific 
questions below, to determine further actions, as appropriate.  
Proposed subpart E would establish standards for an indicator organism in agricultural 
water applied to covered produce, and establish requirements for waters that do not meet those 
standards.  We are soliciting comments on pot ential means or mechanisms for meeting the 
proposed standards.  In your responses, please distinguish, to the extent appropriate, between 
sprouts and other covered produce.  
1. Do farms that would be covered by the proposed  rule, if finalized, currently treat water 
used for irrigation directly applied to covered produce other than sprouts, or water used to 
irrigate sprouts (whether or not it is di rectly applied)?  We are seeking comments on 
pesticides used to reduce concentration of organisms of concern in water used for such 
irrigation and not pesticides used to prevent biofouling (chemigation). 
2. What actions are currently being taken by farmer s, either on their own or at the request of 
produce handlers or sellers to control the bacter ial loads in water? Please provide data to 
support the information provided. 
3. What water treatment methods do farmers us e to clean their irri gation systems, how 
broadly are they used, and what are the eff ects on the environment?  In what amounts or 
frequency are each of these methods applied?  Please provide data to support the information provided. 433 
 
4. Do farms currently use municipal water source s to irrigate produce th at would be covered 
by this proposed rule, if fi nalized? If so, please provide data on the use rate and 
prevalence of this practice, as well as data regarding e ffects on crop productivity of 
disinfection byproducts in municipal water used to irrigate produce that would be covered 
by the rule.  
5. What sources of irrigation water (for example, munici pal water, surface water and 
groundwater) are most frequently used? If more  than one source is available, is there a 
preference for using one source ove r another? Please explain why.  
In addition, we seek comment on pot ential effects of actions take n as a result of this rule 
on water rights/Tribal Rights.  Are water rights or  Tribal rights likely to be affected by actions 
taken as a result of this rule?  If so, how and to what extent?  
Proposed subpart F would require the use of application method rest rictions, application 
intervals, and/or treatm ent of biological soil amendments of animal origin to reduce exposure of 
covered produce to organisms of public health concern.  We recognize th at the requirements in 
this section may represent a depa rture from current  practices.   
1. How do farms that would be covered by the pro posed rule, if finalized, currently manage 
solid animal waste?  Manage liquid animal waste? 
2. What is the prevalence of composting on fa rms using methods described in proposed 
subpart F? Please provide data or other ava ilable information on the frequency of such 
composting. 
3. Are composting methods other than those de scribed in proposed subpart F currently 
utilized on farms? To what extent?  Please pr ovide data or other available information on 
the frequency of such composting. 434 
 
4. Are currently utilized methods of composting governed by state, c ounty or local laws, 
ordinances or regulations?  Please iden tify in your comments any relevant laws, 
ordinances, or regulations, and incl ude copies if reasonably feasible. 
5. What are the current laws, ordinances, or regulations in produce growing areas that 
govern manure handling and storage?  How if at all do such laws, ordinances, or 
regulations address potentia l environmental effects from methane associated with 
manure? Ammonia? Nitrogen? Phosphorus? Under proposed subpart F, manure may be ch emically treated as an alternative to 
composting that would not require use of an a pplication interval.  We  are also soliciting 
comments on available chemical treatment methods.   
1. Do farms that would be covered by the propos ed rule, if finalized, currently utilize 
chemical treatments to prevent or minimize pathogens in manure? 
2. What types and quantities of chemicals are used for chemical treatment of manure?  
Please describe the treatment protocols, incl uding application time, containment methods, 
and temperature requirements. 
3. Please provide any data or other information re lating to the effectiveness, and the relative 
effectiveness, of these chemical manure treatme nts, as well as any environmental effects 
of their use. Proposed subpart I would apply when under the circumstances there is a reasonable 
probability that animal intrusion will contamin ate covered produce.  In such circumstances, 
proposed subpart I would require monitoring of t hose areas that are used for a covered activity 
for evidence of animal intrusion immediately pr ior to harvest and as n eeded during the growing 
season.  If significant evidence of animal intr usion is found, these provisions would require 435 
 
farms to evaluate whether the covered produce can be harvested in accordance with proposed 
subpart K.  Proposed subpart K would require taking r easonable measures to identify, and not 
harvest, covered produce that is  reasonably likely to be contam inated, including steps to identify 
and not harvest covered produce th at is visibly contaminated with animal excreta.  We are 
soliciting comments on current practices  relevant to these provisions. 
1. What measures, if any, are currently being implemented to prevent harvest of produce 
contaminated by excreta deposited by wild animals? If there ar e preferred measures, 
please explain the rationale fo r such preference.  Please provide data to support the 
information provided. 
2. Are farms removing vegetation bordering outdoo r produce growing areas or drainages in 
an effort to deter wildlife from entering growi ng areas?  If so, what is  the current rate at 
which vegetation bordering outdoor produce gr owing areas or drainages is currently 
being removed?  Are sediment basins or other conservation pract ices currently being 
removed and at what rate?  Please provide data or other information to support the 
information provided.  
3. To what extent have farmers taken acti on to exclude wildlife from outdoor produce 
growing areas?  What measur es are being used for these purposes, e.g. c onstruction of 
fences or other physical barriers, chemi cal deterrents, or other mechanisms around 
growing areas to exclude wildlife?  Please pr ovide data or other information to support 
the information provided.   
4.   Has the implementation of measures to pr event animal intrusion negatively impacted 
habitat for rare or declining aquatic or terrestrial wildlife species or migratory birds?  
Please provide examples. 436 
 
 
X. References  The following references have been placed  on display in the Division of Dockets 
Management (see ADDRESSES) and may be seen by interested persons between 9 a.m. and 4 
p.m., Monday through Friday. (FDA has verified the Web site addresses, but FDA is not 
responsible for any subsequent changes to the Web sites after this document publishes in the 
Federal Register
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http://www.cdc.gov/salmonella/saint paul/alfalfa/archive/042709.html . Accessed December 28, 
2011. Last Modified 2009.  273.  "Information on the Recalled Jensen Farms Whole Cantaloupes." Food and Drug 
Administration. http://www.fda.gov/Food/FoodSafet y/CORENetwork/ucm272372.htm#report
.  
Last Modified 2011.   474 
 
List of Subjects 
21 CFR Part 16  
 Administrative prac tice and procedure. 
21 CFR Part 112  
Foods, Fruits and vegetables, Incorporati on by reference, Packaging and containers, 
Recordkeeping requirements, Safety. Therefore, under the Federal Food, Drug, and Cosm etic Act and under authority delegated to the 
Commissioner of Food and Drugs, it is proposed that 21 CFR Chapter I be amended to read as 
follows: PART 16—REGULATORY HEARI NG BEFORE THE FOOD AND DRUG 
ADMINISTRATION  1. The authority citation for 21 CFR pa rt 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. 
2. In §16.1: a. In paragraph (b)(1), add an  entry in numerical order. 
b. In paragraph (b)(2), add an  entry in numerical order. 
The additions read as follows: 
§ 16.1 Scope.
 
*****  (b)*** 
(1)*** 475 
 
Section 419(c)(2)(D) of the Federal Food, Drug, and Cosmetic Act relating to the 
modification or revocation of a variance from the requirements of section 419 of the Federal 
Food, Drug, and Cosmetic Act (see part 112, subpart P of this chapter). *****  (2) ***  §§112.201 through 112.211, (part 112, subpart R), re lating to withdrawal of a qualified 
exemption. *****  3. Add part 112 to read as follows: PART 112--STANDARDS FOR THE GROW ING, HARVESTING,  PACKING, AND 
HOLDING OF PRODUCE FO R HUMAN CONSUMPTION 
Subpart A – General Provisions Sec. 
112.1 What food is covered by this part? 
112.2 What produce is not covered by this part? 112.3 What definitions apply to this part? 112.4 Who is subject to the re quirements of this part? 
112.5 Who is eligible for a qualified exemption a nd associated modified requirements based on 
average monetary value of all food sold and direct farm marketing?  
112.6 What modified requirements apply to me if  I am eligible for a qualified exemption in 
accordance with § 112.5? 
Subpart B--General Requirements  
112.11 What general requirements apply to persons who are subj ect to this part? 476 
 
112.12 Are there any alternatives to the re quirements establishe d in this part? 
Subpart C--Standards Directed to Pe rsonnel Qualificati ons and Training 
112.21 What requirements apply re garding qualifications and training for personnel who handle 
(contact) covered produce or  food-contact surfaces? 
112.22 What minimum requirements apply for traini ng personnel who conduct a covered activity? 
112.23 What requirements appl y regarding supervisors? 
112.30 Under this subpart, what requir ements apply regarding records? 
Subpart D--Standards Directed to Health and Hygiene 112.31 What measures must I take to prevent ill or  infected persons from contaminating covered 
produce with microorganisms of public health significance? 
112.32 What hygienic practices must personnel use? 112.33 What measures must I take to prevent vi sitors from contaminating covered produce and 
food-contact surfaces with microorgani sms of public health significance? 
Subpart E--Standards Directed to Agricultural Water 
112.41 What requirements apply to th e quality of agri cultural water? 
112.42 What measures must I take with respect to my agricultural water sources, water distribution 
system, and pooling of water? 
112.43 What treatment of agricultural water is re quired, and what requirements apply to treating 
agricultural water? 
112.44 What testing is required for agricultural water,  and what must I do based on the test results? 
112.45 How often must I test agricultural water that is subject to re quirements of § 112.44? 
112.46 What measures must I take for water that  I use during harvest, packing, and holding 
activities for covered produce? 477 
 
112.50 Under this subpart, what requir ements apply regarding records? 
Subpart F--Standards Directed to Biological Soil Amendments of Animal Origin and Human Waste 
112.51 What requirements apply for determining th e status of a biologi cal soil amendment of 
animal origin? 
112.52 How must I handle, convey, and store biol ogical soil amendments of animal origin? 
112.53 What prohibitions apply rega rding use of human waste? 
112.54 What treatment processes are acceptable for a biological soil amendment of animal origin 
that I apply in the grow ing of covered produce? 
112.55 What microbial standards apply to the treatment processes in § 112.54? 
112.56 What application requirements and minimum a pplication intervals apply to biological soil 
amendments of animal origin? 
112.60 Under this subpart, what requir ements apply regarding records? 
Subpart G—[Reserved] 
Subpart H—[Reserved] 
Subpart I--Standards Directed to Domesticated and Wild Animals  
112.81 How do the requirements of this subpart apply to areas where covered activities take place? 
112.82 What requirements apply regarding domesticated  animals that I allow to graze in fields or 
use as working animals where I grow covered produce? 
112.83 What requirements apply re garding animal intrusion? 
Subpart J—[Reserved] Subpart K--Standards Directed to Growing, Harvesting, Packing, and Holding Activities 
112.111 What measures must I take if I grow, ha rvest, pack or hold both covered and excluded 
produce?   478 
 
112.112 What measures must I take  during harvest activities? 
112.113 How must I handle harvested covere d produce during covered activities? 
112.114 What requirements apply to dropped covered produce? 
112.115 What measures must I take when packaging covered produce? 
112.116 What measures must I take when using food-packing (incl uding food packaging) material? 
Subpart L--Standards Directed to Equipm ent, 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 th e requirements of this subpart? 
112.123 What requirements apply regarding equi pment and tools subject to this subpart? 
112.124 What requirements apply to instruments and c ontrols used to measure,  regulate, or record? 
112.125 What requirements apply to equipmen t 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 domesti cated animals in and around a fully-enclosed 
building? 
112.128 What requirements apply regard ing pest control in buildings? 
112.129 What requirements appl y to toilet facilities? 
112.130 What requirements apply for hand-washing facilities? 112.131 What must I do to contro l and dispose of sewage? 
112.132 What must I do to control and dispose of tras h, litter, and waste in areas used for covered 
activities? 
112.133 What requirements apply to plumbing? 479 
 
112.134 What must I do to control animal excreta a nd litter from domesticat ed animals that are 
under my control? 
112.140 Under this subpart, what requir ements apply regarding records? 
Subpart M--Standards Directed to Sprouts  112.141 What requirements apply to seeds or beans used to grow sprouts? 
112.142 What measures must I take for growi ng, harvesting, packing, and holding sprouts? 
112.143 What testing must I do during growing, harvesting, packing, and holding sprouts? 
112.144 What requirements apply to te sting the environment for Listeria
 species or L. 
monocytogenes ? 
112.145 What actions must I take if the growing, harvesting, packing, or holding environment tests 
positive for Listeria  species or L. monocytogenes ? 
112.146 What must I do to collect and test samples of spent sprout irriga tion water or sprouts? 
112.150 Under this subpart, what requir ements apply regarding records? 
Subpart N--Analytical Methods 
112.151 What methods must I use to test the qualit y of water to satisfy the requirements of § 
112.45? 
112.152 What methods must I use to test the growing environment for Listeria  species or L. 
monocytogenes  to satisfy the requirements of § 112.143(a) and § 112.144? 
Subpart O--Requirements Applying to Reco rds That You Must Establish and Keep 
112.161 What general requirements apply to  records required under this part? 
112.162 Where must I store records? 112.163 May I use existing records to satis fy the requirements of this part? 
112.164 How long must I keep records? 480 
 
112.165 What formats are acceptable for the records I keep? 
112.166 What requirements apply for making re cords available and accessible to FDA? 
112.167 Can records that I provide to FDA be disclosed to persons outside of FDA? 
Subpart P--Variances  112.171 Who may request a variance from the requirements of this part? 
112.172 How may a State or foreign country request a variance from one or more requirements of 
this part? 
112.173 What must be included in the Statement of  Grounds in a petition requesting a variance? 
112.174 What data and information submitted in a petition requesting a va riance are publicly 
available? 
112.175 Who responds to a petiti on requesting a variance? 
112.176 What process applies to a petition requesting a variance? 
112.177 Can an approved variance apply to any person other than those identified in the petition 
requesting that variance? 
112.178 Under what circumstances may FDA deny a petition requesting a variance? 
112.179 When does a variance approved by FDA become effective? 112.180 Under what circumstances may FDA modi fy or revoke an approved variance? 
112.181 What procedures apply if FDA determines that an approved variance should be modified 
or revoked? 
112.182 What are the permissible types of  variances that may be granted? 
Subpart Q--Compliance and Enforcement  112.191 How do the criteria and definitions in this  part apply to the Federal Food, Drug, and 
Cosmetic Act and the Public Health Service Act? 481 
 
112.192 What is the result of a failure  to comply with this part? 
112.193 What are the provisions for coordina tion of education and enforcement?  
Subpart R--Withdrawal of Qualified Exemption 112.201 Under what circumstances can FDA withdraw  a qualified exempti on 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 withdraw a qualified exemption? 
112.204 What must I do if I receive an order to w ithdraw a qualified exemp tion applicable to my 
farm? 
112.205 Can I appeal or request a hearing on an orde r 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 re questing an informal hearing? 
112.208 What requirements are applicab le to an informal hearing? 
112.209 Who is the presiding officer for an appeal and for an informal hearing? 
112.210 What is the timeframe for i ssuing a decision on an appeal? 
112.211 When is an order to withdraw a qualified exemption applicable to a farm revoked? 
Authority
: 21 U.S.C. 321, 331, 342, 350h, 371; 42 U.S.C. 243, 264, 271. 
Subpart A--General Provisions § 112.1  What food is co vered 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 agricu ltural commodity (RAC) is covered by this part.  
This includes a produce RAC that is grown do mestically and a produce RAC that will be 482 
 
imported or offered for import in any State or te rritory of the United States, the District of 
Columbia, or the Commonwealth of Puerto Rico.   
(b) For the purpose of this part and subject  to the exemptions and qualified exemptions 
therein, covered produce incl udes all of the following: 
(1) Fruits and vegetables such as almonds, a pples, apricots, aprium, asian pear, avocados, 
babaco, bamboo shoots, bananas, Belgian endive,  blackberries, bl ueberries, broccoli, cabbage, 
cantaloupe, carambola, carrots, cau liflower, celery, cherries, c itrus (such as clementine, 
grapefruit, lemons, limes, mandarin, oranges, ta ngerines, tangors, and uniq fruit), cucumbers, 
curly endive, garlic, grapes, green beans, guava, herbs (such as basil, chives, cilantro, mint, 
oregano, and parsley), honeydew, kiwifruit, le ttuce, mangos, other melons (such as canary, 
crenshaw and persian), mushrooms, nectarine, onions, papaya, passion fruit, peaches, pears, 
peas, peppers (such as bell and hot), pineapple, pl ums, plumcot, radish, raspberries, red currant, 
scallions, snow peas, spinach, sprouts (such as alfalfa and mung bean), strawberries, summer 
squash (such as patty pan, yellow and zucchini), tomatoes, walnuts, watercress, and watermelon; 
and  (2) Mixes of intact fruits and ve getables (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 – arrowhead, arrowroot, artichoke s, asparagus, beets, black-eyed peas, bok choy, 
brussels sprouts, chick-peas, collard greens, cr abapples, cranberries, eggplant, figs, ginger root, 
kale, kidney beans, lentils, lima beans, okra, pars nips, peanuts, pinto beans, plantains, potatoes, 483 
 
pumpkin, rhubarb, rutabaga, sugarbee t, sweet corn, sweet potatoes, ta ro, turnips, water chestnuts, 
winter squash (acorn and bu tternut squash), and yams;  
(2) Produce that is produced by an individua l for personal consumption or produced for 
consumption on the farm or another farm under the same ownership; and 
(3) Produce that is not a ra w agricultural commodity. 
(b) Covered produce is eligible for exemption from the requirements of this part (except 
as noted in paragraphs (b)(1), (b)(2), and (b)(3 ) of this section) under the following conditions: 
(1) The covered produce receiv es commercial processing that  adequately reduces the 
presence of microorganisms of public health si gnificance.  Examples of commercial processing 
that adequately reduces the presence of micr oorganisms of public health significance are 
processing in accordance with the requirements of  parts 113, 114, or 120 of this chapter, treating 
with a validated process to eliminate spore- forming microorganisms (such as processing to 
produce tomato paste or shelf-stable tomatoes), and processing such as refining or distilling 
produce into products such as sugar, o il, spirits, or similar products;  
(2) You must establish and keep documentati on in accordance with the requirements of 
subpart O of this part, of the id entity of the recipien t of the covered produce that performs the 
commercial processing described in paragr aph (b)(1) of this section; and  
(3) The requirements of this subpart and subpart  Q of this part appl y to such produce.   
§ 112.3  What definitions apply to this part?  
(a) The definitions and interpretations of terms in section 201 of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 321) apply to such terms when used in this part.   
(b) For the purpose of this part, the following definitions of very small business and small 
business also apply: 484 
 
(1) Very small business .  For the purpose of this part, your fa rm is a very small business if it is 
subject to this part and, on a rol ling basis, the average annual monetary value of food (as defined 
in paragraph (c) of this section) you sold duri ng the previous 3-year period is no more than 
$250,000. (2) Small business
.  For the purpose of this part, your farm  is a small business if it is subject to 
this part and, on a rolling basis, the average annual monetary value of food (as defined in 
paragraph (c) of this section) you sold during the previous 3-year period is no more than 
$500,000; and your farm is not a very small busine ss as provided in paragraph (b)(1) of this 
section.  (c) For the purpose of this part, th e following definitions also apply: 
Adequate
 means that which is needed to accomplis h 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 mate rials (such as humus, manure, non-fecal 
animal byproducts, peat moss, pre-co nsumer vegetative waste, tabl e waste, or yard trimmings), 
excluding any form of human waste, produced to transfer microbial biomass, fine particulate 
organic matter, and soluble chemical components in to an aqueous phase.  Agricultural teas are 
held for longer than one hour before application. Agricultural tea additive
 means a nutrient source (such as molasses, yeast extract, or algal 
powder) added to agricultural tea to increase microbial biomass. 
Agricultural water  means water used in covered activit ies on covered produce where water is 
intended to, or is likely to, contact covered produce or food-c ontact surfaces, including water 485 
 
used in growing activities (inc luding 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 (inc luding water used for washing or cooling 
harvested produce and water used for pr eventing dehydration of covered produce). 
Animal excreta  means solid or liquid animal waste.  
Application interval  means the time interval between appli cation of an agricultu ral input (such as 
a biological soil amendment of animal origin) to a growing area and harvest of covered produce 
from the growing area where the agricultural input was applied.  
Biological soil amendment  means any soil amendment containing biological materials such as 
humus, manure, non-fecal animal byproducts, peat moss, pre-consumer vegetative waste, sewage 
sludge biosolids, table waste, ag ricultural tea, or yard trimmi ngs, alone or in combination.  
Biological soil amendment of animal origin  means a biological soil amendment which consists, 
in whole or in part, of materials of animal  origin, such as manure or non-fecal animal 
byproducts, or table waste, alone or in combina tion.  The term “biological soil amendment of 
animal origin” does not include  any form of human waste. 
Composting  means a process to produce humus in whic h organic material is decomposed by the 
actions of microorganisms under thermophilic cond itions for a designated period of time (for 
example, 3 days) at a designated temperature (f or example, 131°F (55 °C)), followed by a curing 
stage under cooler conditions.  Covered activity
 means growing, harvesting, packing, or hol ding covered produce, provided that 
all covered produce used in covere d packing or holding activities is grown, raised, or consumed 
on that farm or another farm under the same ownership.  Covered ac tivity does not include 486 
 
manufacturing/processing within th e meaning defined in this chapter.   This part does not apply to 
activities of a facility that are subject to part 110 of this chapter. 
Covered produce  means produce that is subjec t to the requirements of this part in accordance 
with §§ 112.1 and 112.2.  The term “covered produce” re fers to the harvestable or harvested part 
of the crop.   Curing
 means the maturation stage of composting, wh ich is conducted after much of the readily 
metabolized biological material ha s been decomposed, at cooler te mperatures than those in the 
thermophilic phase of composting, to further reduce pathogens, promote further decomposition of cellulose and lignin, and stabilize composition. 
Direct water application method
 means using agricultural water in  a manner whereby the water is 
intended to, or is likely to, c ontact covered produce or  food-contact surfaces  during use of the 
water. Farm
 means a facility (as defined in § 1.227 of th is chapter) in one general physical location 
devoted to the growing and harv esting of crops, the raising of animals (including seafood) or 
both. Farm includes: (i) Facilities that pack or hold food, provided that a ll food used in such activities is grown, raised, 
or consumed on that farm or another farm under the same ownership; and  
(ii) Facilities that manufacture/ process food, provided that all f ood used in such activities is 
consumed on that farm or another farm under same ownership. Food
 means food as defined in section 201(f) of  the Federal Food, Drug, and Cosmetic Act and 
includes seeds and beans used to grow sprouts. Food-contact surfaces
 means those surfaces that contact human food and those surfaces from 
which drainage, or other transfer, onto the food or  onto surfaces that contact the food ordinarily 487 
 
occurs during the normal course of operations . “Food-contact surfaces” includes food-contact 
surfaces of equipment and tools used  during harvest, packing and holding. 
Growth media  means material that acts as a substr ate during the growth of covered produce 
(such as mushrooms and some sprouts) that c ontains, may contain, or consists of components 
that may include any animal waste (such as hum us, manure, non-fecal animal byproducts or table 
waste). Harvesting
 applies to farms and farm mixed-type facilities and means activities that are 
traditionally performed by farms for the purpose of  removing raw agricultural commodities from 
the place they were grown or raised and preparing them for use as food.  Harvesting is limited to activities performed on raw agricultural commoditie s on the farm on which they were grown or 
raised, or another farm under the same ownershi p.  Harvesting does not include activities that 
transform a raw agricultural commodity, as de fined in section 201(r) of the Federal Food, Drug, 
and Cosmetic Act, into a processed food as de fined in section 201(gg) of the Federal Food, Drug, 
and Cosmetic Act.  Gathering, washing, trimming of outer leaves of, removing stems and husks 
from, sifting, filtering, threshing, shelling, and cooling raw agricultural commodities grown on a farm or another farm under the same ownership are examples of harvesting.  Hazard
 means any biological agent that is reasonably  likely to cause illness or injury in the 
absence of its control. Holding
 means storage of food. Holdi ng facilities include warehouses , cold storage facilities, 
storage silos, grain elevators, and liquid storage tanks. For farms and farm mixed-type facilities, 
holding also includes activit ies traditionally perfor med by farms for the safe or effective storage 
of raw agricultural commodities grown or raised on the same farm or another farm under the same ownership, but does not in clude activities that transform a raw agricultural commodity, as 488 
 
defined in section 201(r) of the Federal Food, Drug, and Cosmetic Act, into a processed food as 
defined in section 201(gg) of the Federal Food, Drug, and Cosmetic Act. 
Humus  means a stabilized (i.e., finished) biol ogical soil amendment produced through a 
controlled composting process. Manufacturing/processing
 means making food from one or mo re ingredients, or synthesizing, 
preparing, treating, modifying or manipulating food, including food crops  or ingredients. 
Examples of manufacturing/processing activ ities are cutting, pee ling, trimming, washing, 
waxing, eviscerating, rendering, cooking, baki ng, freezing, cooling, pasteurizing, homogenizing, 
mixing, formulating, bottling, milling, grinding, ex tracting juice, dist illing, labeling, or 
packaging.  For farms and farm mixed-type faci lities, manufacturing/proc essing does not include 
activities that are part of harvesting, packing, or holding. 
Manure  means animal excreta, alone or in combina tion 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 significan ce. The term “undesirable microorganisms” 
includes those microorganisms that are of public  health significance, that subject food to 
decomposition, that indicate that food is contamin ated with filth, or that otherwise may cause 
food to be adulterated.  
Mixed-type facility  means an establishment that engages in both activities that  are exempt from 
registration under sectio n 415 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 350d) 
and activities that require the establishment to be registered.  An example of  such a facility is a 
“farm mixed-type facility,” whic h is an establishment that grow s and harvests crops or raises 489 
 
animals and may conduct other activities within th e farm definition, but also conducts activities 
that require the establishment to be registered. Monitor
 means to conduct a planned sequence of observations or measurements to assess 
whether a process, point or procedure is unde r control and, when appl icable, to produce an 
accurate record of the observation or measurement. Non-fecal animal byproduct
 means solid waste (other than excret a) 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), fi sh emulsions, and offal)  and is generated by 
commercial, institutional, or agricultural operations. Packaging
 (when used as a verb) means placing food in to a container that directly contacts the 
food and that the consumer receives.   
Packing  means placing food into a container other th an packaging the food.  For farms and farm 
mixed-type facilities, packing also include s activities (which may include packaging) 
traditionally performed by farms to prepare raw agricultural commodities grown or raised on the 
same farm or another farm under the same owne rship for storage and transport, but does not 
include activities that transform a raw agricultural  commodity, as defined in section 201(r) of the 
Federal Food, Drug, and Cosmetic Act, into a pro cessed food as defined in section 201(gg) of the 
Federal Food, Drug, and Cosmetic Act.   Pest
 means any objectionable animals or insects including birds, rodents, flies, and larvae. 
Pre-consumer vegetative waste  means solid waste that is purely vegetative in origin, not 
considered yard trash, and derived from commer cial, institutional, or agricultural operations 
without coming in contact with animal products , byproducts or manure or with an end user 
(consumer).  Pre-consumer vegetative waste includes material generated by farms, packing 490 
 
houses, canning operations, wholesale distribution centers and grocery stores; products that have 
been removed from their packaging (such as ou t-of-date juice, vegetables, condiments, and 
bread); and associated packaging that is vegetativ e 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 ar e not vegetative in origin, or any waste generated 
by restaurants. Produce
 means any fruit or vegetable (including mi xes of intact fruits and vegetables) and 
includes mushrooms, sprouts (irresp ective of seed source), peanuts, tree nuts and herbs.  A fruit 
is the edible reproductive body of a seed plant or  tree nut (such as appl e, orange and almond) 
such that fruit means the harvestable or harveste d 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 pl ant or fungus whose fruit, fleshy fruiting bodies, 
seeds, roots, tubers, bulbs, stems, leaves, or  flower parts are used as food and includes 
mushrooms, sprouts, and herbs (such as basil or cilantro).  Produce does not include food grains 
meaning the small, hard fruits or seeds of arable crops, or the crops bearing these fruits or seeds, 
that are grown and processed for use as meal, flour , baked goods, cereals and oils rather than for 
fresh consumption (including cereal grains, pseudo cereals, oilseeds and other plants used in the 
same fashion).  Examples of food grains include barley, dent- or flint-corn, sorghum, oats, rice, 
rye, wheat, amaranth, quinoa, buckwheat, cotton seed, and soybeans. Production batch of sprouts
 means all sprouts that are star ted at the same time in a single 
growing unit (e.g., a single drum or bin, or a sing le rack of trays that are connected to each 491 
 
other), whether or not the sprout s are grown from a single lot of  seed (including, for example, 
when multiple types of seeds are grown in a single growing unit). Qualified end-user
 with respect to a food  means the consumer of the food; or a restaurant or 
retail food establishment (as those terms are defined in § 1.227) that is located:  
(i) In the same State as the fa rm that produced the food; or  
(ii) Not more than 275 miles from such farm.  The term “consumer” does not include a business. Raw agricultural commodity (RAC)
 means “raw agricultural commodity” as defined in section 
201(r) of the Federal Food, Drug, and Cosmetic Act. Reasonably foreseeable hazard
 means a potential hazard that may be  associated with the farm or 
the food. Sanitize
 means to adequately treat cleaned food-contac t surfaces by a process that is effective in 
destroying vegetative cells of micr oorganisms of public health si gnificance, and in substantially 
reducing numbers of other undesirable microorga nisms, but without adversely affecting the 
product or its safety for the consumer.   
Sewage sludge biosolids  means the solid or semi-solid residu e generated during the treatment of 
domestic sewage in a treatment works within th e meaning of the definition of “sewage sludge” in 
40 CFR 503.9(w).  Soil amendment
 means any chemical, biological, or physical material (such as elemental 
fertilizers, humus, manure, non-fecal animal byproducts, peat moss, perlite, pre-consumer 
vegetative waste, sewage sludge biosolids, tabl e waste, agricultural tea and yard trimmings) 
intentionally added to th e soil to improve the chemical or phys ical condition of so il in relation to 
plant growth or to improve the cap acity of the soil to hold water.   The term soil amendment also 492 
 
includes growth media that serve as the entire  substrate during the gr owth of covered produce 
(such as mushrooms and some sprouts). Spent sprout irrigation water
 means water that has been used  in the growing of sprouts. 
Static composting  means a process to produce humus in wh ich air is introduced into biological 
material (in a pile (or row) covere d with at least 6 inches of insula ting material, or in an enclosed 
vessel) by a mechanism that does not include turn ing.  Examples of structural features for 
introducing air include embedded perforated pipes and a constructed permanent base that 
includes aeration slots.  Examples of mechanis ms for introducing air include passive diffusion 
and mechanical means (such as blowers that sucti on air from the composting material or blow air 
into the composting material using positive pressure).  Surface water
 means all water which is open to the at mosphere and subject to surface runoff, 
including water obtained from an  underground aquifer that is held  or conveyed in a manner that 
is open to the  atmosphere, such as in canals, ponds, other surface containment or open 
conveyances. 
Table waste  means any post-consumer food waste, irresp ective of whether the source material is 
animal or vegetative in origin, derived from individuals, institutions, restaurants, retail 
operations, or other sources where the food has been served to a consumer. 
Turned composting  means a process to produce humus in wh ich air is introduced  into biological 
material (in a pile, row, or encl osed vessel) by turning on a regular  basis. Turning is the process 
of mechanically mixing biological material that  is undergoing a composting process with the 
specific intention of moving the ou ter, cooler sections of the ma terial being composted to the 
inner, hotter sections. 493 
 
Water distribution system  means a system to carry water from its primary source to its point of 
use, including pipes, sprinkler s, irrigation canals, pumps, va lves, storage tanks, reservoirs, 
meters, and fittings. We
 means the U.S. Food and Drug Administration (FDA). 
Yard trimmings  means purely vegetative matter resulti ng from landscaping maintenance or land 
clearing operations, including materials such as tree and shrub trimmings, grass clippings, palm 
fronds, trees, tree stumps, untreated lumber, untre ated wooden pallets, and associated rocks and 
soils. You
 means a person who is subject to some or  all of the requirements in this part. 
§ 112.4  Who is subject to the requirements of this part?  
(a) Except as provided in paragr aph (b) of this section, if you are a farm or farm mixed-
type facility with an averag e annual monetary value of food (as “food” defined in § 112.3(c)) 
sold during the previous 3-y ear period of more than $25,000 (on a rolling basis), you are a 
“covered farm” subject to this part.  If you are a covered farm subject to this part, you must 
comply with all applicable requ irements of this part when you conduct a covered activity on 
covered produce.  
(b) You are not a covered farm if you satisfy  the requirements in § 112.5 and we have not 
withdrawn your exemption in accordance with th e requirements of subpart R of this part. 
§ 112.5  Who is eligible for a qualified exempti on and associated modified requirements based 
on average monetary value of all fo od sold and direct farm marketing?  
(a) You are eligible for a qualified exemption and associated modified requirements in a 
calendar year if: 494 
 
(1) During the previous 3-year period preceding the applicable calendar year, the average annual 
monetary value of the food (as defined in § 112.3( c)) you sold directly to  qualified end-users (as 
defined in § 112.3(c)) during such period exceeded  the average annual monetary value of the 
food you sold to all other buyers during that period; and  (2) The average annual monetary value of all fo od (as defined in § 112.3(c)) you sold during the 
3-year period preceding the applicable cale ndar year was less than $500,000, adjusted for 
inflation.  
(b) For the purpose of determining whether th e average annual monetary value of all food 
sold during the 3-year period preceding the a pplicable 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  I am eligible for a qualified exemption in 
accordance with § 112.5?  
(a) If you are eligible for a qualified ex emption in accordance with § 112.5, you are 
subject to the requirements of: 
(1) This subpart A; and (2) Subparts Q and R of this part. 
(b) In addition, you are subject to th e following modified requirements: 
(1) When a food packaging label is required on food that would otherwise be covered produce 
under the Federal Food, Drug, and Cosmetic Act or its implementing regulations, you must 
include prominently and conspicuously on the f ood 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 requir ed on food that would otherwise be covered 
produce under the Federal Food, Drug, and Cosm etic Act, you must prominently and 495 
 
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 c ourse of business, or, in the case of Internet 
sales, in an electronic notice. 
(3) The complete business a ddress that you must include  in accordance with the 
requirements of paragraph (b)(1) or  (b)(2) of this secti on must include the street address or post 
office box, city, state, and zip code for domestic farms, and comparable full address information 
for foreign farms. Subpart B--General Requirements § 112.11  What general requirements apply to persons who are subject to this part?
 
You must take appropriate measures to mi nimize the risk of serious adverse health 
consequences or death from the use of, or exposure to, covered produce, including those 
measures reasonably necessary to prevent the introduction of known or reasonably foreseeable 
hazards into covered produce, and to provide reasonable assurances that the produce is not 
adulterated under section 402 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 342) on 
account of such hazards. § 112.12  Are there any alternatives to the requirements established in this part?
 
(a) You may establish alternatives to the fo llowing specific requirements of this part, 
provided that you satisfy the requirements of paragraphs (b) and (c ) of this section: 
(1) The requirements in § 112.44(c) for testing wa ter, and taking action ba sed on test results, 
when agricultural water is used during growi ng operations for covered produce (other than 
sprouts) using a direct water application method; 
(2) Composting treatment processes es tablished in § 112.54( c)(1) and (c)(2); 496 
 
(3) The minimum application interval establishe d in § 112.56(a)(1)(i) for an untreated biological 
soil amendment of animal origin that is reas onably likely to cont act covered produce after 
application or for a compost agricultural tea that  contains compost agricultural tea additives; and 
(4) The minimum application interval establ ished in § 112.56(a)(4)(i) for a biological soil 
amendment of animal origin treated by a composting process that is reasonably likely to contact 
covered produce after application. 
(b) You may establish and use an alternativ e to any of the requirements listed in 
paragraph (a) of this section, provided you have adequate scientific data or information to 
support a conclusion that the altern ative would provide the same le vel of public health protection 
as the applicable requirement established in this part (including meeting the same 
microbiological standards, where applicable), and would not in crease the likelihood that your 
covered produce will be adulterated under sectio n 402 of the Federal Food, Drug, and Cosmetic 
Act, in light of your covered produce, practi ces, and conditions, incl uding agro-ecological 
conditions and application interval. 
(c) Scientific data and inform ation used to support an altern ative to a requirement listed 
in paragraph (a) of this section may be develope d by you, available in the sc ientific lite rature, or 
available to you through a third pa rty.  You must establish and maintain documentation of the 
scientific data and information on which you rely in accordance with the requirements of subpart O of this part. Subpart C--Standards Directed to Pe rsonnel Qualifications and Training  
§ 112.21  What requirements apply regarding qualifications and trai ning for personnel who 
handle (contact) covered produ ce or food-contact surfaces?  497 
 
All of the following requirements apply regarding qualifications and training for 
personnel who handle (contact) covered produce or food-contact surfaces: 
(a) All personnel (including temporary, part time, seasonal, and contracted personnel) 
who handle covered produce or food-contact surfaces, or who are engaged in the supervision thereof, must receive adequate training, as a ppropriate to the person’s duties, upon hiring, at the 
beginning of each growing season (if applic able), and periodi cally thereafter.  
 (b) All personnel (including temporary, part  time, seasonal, and contracted personnel) 
who handle covered produce or food-contact surfaces, or who are engaged in the supervision thereof, must have the training, in combinati on with education or experience to perform the 
person’s assigned duties in a manner that ensures compliance with this part.  
 (c) Training must be conducted in a manne r 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 pers onnel are not meeting standards established by FDA in subparts 
C through O of this part.   § 112.22  What minimum requirements apply fo r training personnel who conduct a covered 
activity?  
(a) At a minimum, all personnel who handl e (contact) covered produce during covered 
activities or supervise th e conduct of such activities must rece ive training that includes all of the 
following: (1) Principles of food hygiene and food safety;  498 
 
(2) The importance of health and personal hyg iene for all personnel and visitors, including 
recognizing symptoms of a health condition that is  reasonably likely to result in contamination of 
covered produce or food-contact surfaces with mi croorganisms of public health significance; and  
(3) The standards established by FDA in subparts C through O of this part th at are applicable to 
the employee’s job responsibilities.  
(b) Persons who conduct harvest activities for covered produce  must also receive training 
that includes all of the following: (1) Recognizing covered produce th at should not be harvested, in cluding covered produce that 
may be contaminated with known or reasonably foreseeable hazards;  (2) Inspecting harvest containers  and equipment to ensure that  they are functioning properly, 
clean, and maintained so as not to become a s ource of contamination of covered produce with 
known or reasonably foreseeable hazards; and (3) Correcting problems with harvest containers or  equipment, or reporting such problems to the 
supervisor (or other responsible party), as a ppropriate 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. § 112.23  What requirements apply regarding supervisors?
 
You must assign or identify personnel to supe rvise (or otherwise be responsible for) your 
operations to ensure compliance with  the requirements of this part. 
§ 112.30  Under this subpart, what re quirements apply regarding records?  
(a) You must establish and keep records requir ed under this subpart C in accordance with 
the requirements of subpart O of this part. 499 
 
(b) You must establish and keep records of  training that document required training of 
personnel, including the date of training, topics covered, and the persons(s) trained. 
Subpart D--Standards Directed to Health and Hygiene § 112.31  What measures must I take to prevent ill or infected persons  from contaminating
 
covered produce with microorganism s of public health significance?  
(a) You must take measures to prevent contamination of covered produce and food-
contact surfaces with microorganisms of public health significance from any person with an 
applicable health condition (such as a communicable illnesses that present a public health risk in 
the context of normal work duties, infec tion, open lesion, vomiting, or diarrhea).  
(b) The measures you must take to satisfy the requirements of paragraph (a) of this 
section must include all of the following measures: (1) Excluding any person from working in any op erations that may resu lt in contamination of 
covered produce or food-contact surfaces with  microorganisms of public health significance 
when the person (by medical examination, the person’s acknowledgement , or observation) is 
shown to have, or appears to have, an applic able health condition, unt il the person’s health 
condition no longer presents a risk to public health; and  
(2) Instructing personnel to notify th eir supervisor(s) (or a responsible party) if they have, or if 
there is a reasonable possibility that th ey have an applicable health condition. 
§ 112.32  What hygienic practi ces must personnel use?
 
(a) Personnel who work in an operation in  which covered produce or food-contact 
surfaces are at risk of contam ination with known or reasonably foreseeable hazards must use 
hygienic practices while on duty to the extent nece ssary to protect against such contamination.  500 
 
(b) The hygienic practices that personnel use to satisfy the re quirements of paragraph (a) 
of this section when handling (contacting) c overed produce or food-contact surfaces during a 
covered activity must include all of the following practices: 
(1) Maintaining adequate personal cleanliness to protect against contamination of covered 
produce and food-contact surfaces;  (2) Avoiding contact with animals other than wo rking animals, and taking appropriate steps to 
minimize the likelihood of contamination of cove red produce when in direct contact with 
working animals;  (3)  Washing hands thoroughly, including scrubbing with soap and running water that satisfies 
the requirements of § 112.44(a) (as applicable) fo r water used to wash hands, and drying hands 
thoroughly using single-service to wels, clean cloth towels, san itary towel service or other 
adequate hand drying devices: (i) Before starting work;  
(ii) Before putting on gloves;  
(iii) After using the toilet;  (iv) Upon return to the work station after any br eak or other absence from the work station;  
(v) As soon as practical after t ouching animals (including livestock  and working animals), or any 
waste of animal origin; and (vi) At any other time when the hands may have  become contaminated in a manner that is 
reasonably likely to lead to contamination of covered produce with known or reasonably 
foreseeable hazards; and 501 
 
(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.  § 112.33  What measures must I take to preven t visitors from contaminating covered produce 
and food-contact surfaces with microorga nisms of public health significance?   
(a) A visitor is any person (other than pers onnel) who enters your covered farm with your 
permission. 
(b) You must make visitors aware of policie s 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 w ith such policies and procedures.  
(c) You must make toilet and hand-wash ing facilities accessible to visitors. 
Subpart E--Standards Directed to Agricultural Water § 112.41  What requirements apply to th e quality of agricultural water? 
 
All agricultural water must be safe and of ad equate sanitary quality for its intended use.  
§ 112.42  What measures must I take with resp ect to my agricultural water sources, water 
distribution system, and pooling of water?  
(a) At the beginning of a growing season, you mu st inspect the entire  agricultural water 
system under your control (including water source, water distribution system, facilities, and equipment), to identify conditions  that are reasonably likely to introduce known or reasonably 
foreseeable hazards into or onto covered produc e or food-contact surfac es in light of your 
covered produce, practices, a nd conditions, including consid eration 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;  502 
 
(3) The degree of protection of each agricultural water source;  
(4) Use of adjacent or nearby land; and (5) The likelihood of introduction of known or re asonably foreseeable hazards to agricultural 
water by another user of agri cultural water before  the water reaches your covered farm. 
(b) You must adequately maintain all agri cultural water sources that are under your 
control (such as wells) by regular ly inspecting each source and k eeping the source free of debris, 
trash, domesticated animals, and other possible so urces of contamination of covered produce to 
the extent practicable and appr opriate under the circumstances. 
(c) You must adequately maintain all agricu ltural water distribution systems as necessary 
and appropriate to prevent the wa ter distribution system from bei ng a source of contamination to 
covered produce, food-contact su rfaces, areas used for a cove red activity, or water sources, 
including by regularly inspecting and adequately storing al l equipment used in the system. 
(d) You must immediately discontinue use of  a source of agricultural water and/or its 
distribution system, and not use th e water source and/or its dist ribution system when you have 
determined or have reason to be lieve that your agricultural water is not safe and of adequate 
sanitary quality for its intended use, until you either: 
(1) Re-inspect the entire agricultural water system unde r your control, identify any 
conditions that are reasonably likely to intr oduce known or reasonably foreseeable hazards into 
or onto covered produce or food-cont act surfaces, make necessary ch anges, and test the water to 
determine if your changes were effective and to ensu re that your agricultural water is safe and of 
adequate sanitary quality for its intended use; or 
(2) Treat the water in accordance w ith the requirements of § 112.43.  503 
 
(e) As necessary and appropriate, you must implement measures reasonably necessary to 
reduce the potential for contamin ation of covered produce with known or reasonably foreseeable 
hazards as a result of pooling of water.  Fo r example, such measures may include using 
protective barriers or staking to keep covere d produce from touching the ground or using an 
alternative irrigation method. § 112.43  What treatment of agricultural water is required, and what requirements apply to 
treating agricultural water?  
(a) You must treat any agricultural water that  you use (such as with an EPA-registered 
antimicrobial pesticide product) if you know or have  reason to believe that the water is not safe 
and of adequate sanitary qua lity for its intended use.  
(b) Any method you use to treat agricultural wate r to satisfy the requirement in paragraph 
(a) of this section must be effective to make the water safe and of adequate  sanitary quality for its 
intended use.  
(c)(1) You must deliver any treatment of agri cultural water require d by paragraph (a) of 
this section in a manner to ensure that the treat ed water is consistently safe and of adequate 
sanitary quality for its intended use. (2) You must monitor any treatment of agricultural  water at a frequency ad equate to ensure that 
the treated water is consistently safe and of adequate sanitary quality for its intended use. 
§ 112.44  What testing is required for agricultural water, and what  must I do based on the test 
results?  
(a) You must test the quality of agricultural water according to the requirements in § 
112.45 using a quantitative, or presence-absence method of analysis provided in subpart N of this 504 
 
part to ensure there is no detectable generic Escherichia coli  (E. coli ) in 100 milliliters (mL) of 
agricultural water when it is:  (1) Used as sprout irrigation water;  (2) Applied in any manner that directly c ontacts covered produce during or after harvest 
activities (for example, water that is applied to covered produce for washi ng or cooling activities, 
and water that is applied to harvested crops to prevent dehydration before cooling), including 
when used to make ice that directly contacts covered produce during or after harvest activities; 
 (3) Used to make a tr eated agricultural tea;  
 (4) Used to contact food-contact surfaces, or  to make ice that w ill contact food-contact 
surfaces; or 
(5) Used for washing hands duri ng and after harvest activities. 
(b) If you find that there is any detectable generic E
. coli  in 100 mL of water, you must 
immediately discontinue use of th at source of agricultural water a nd/or its distribution system for 
the uses described in paragraph (a) of this sec tion.  Before you may use the water source and/or 
distribution system again for the uses described in paragraph (a) of this section, you must either 
re-inspect the entire ag ricultural water system under your contro l, identify any conditions that are 
reasonably likely to introduce known or reasonab ly foreseeable hazards into or onto covered 
produce or food-contact surfaces, make necessary ch anges, and retest the water to determine if 
your changes were effective and to ensure that th e water meets the requirements of paragraph (a) 
of this section; or trea t the water in accordance wi th the requirements of § 112.43. 
(c) When agricultural water is used during growing activities for covered produce (other 
than sprouts) using a direct water applicati on method you must test the quality of water in 
accordance with one of the appropria te analytical methods in subpart  N.  If you find that there is 505 
 
more than 235 colony forming units (CFU) (or most probable number (MPN), as appropriate) 
generic E . coli  per 100 mL for any single sample or a roll ing geometric mean (n=5) of more than 
126 CFU (or MPN, as appropriate) per 100 mL of water, you must immediately discontinue use 
of that source of agricultural water and/or its di stribution system for the uses described in this 
paragraph.  Before you may use the water source and/or distribution system again for the uses 
described in this paragraph, you mu st either re-inspect the entire  agricultural water system under 
your control, identify any conditions that are reasonably likely to introduce known or reasonably 
foreseeable hazards into or onto covered produc e or food-contact surf aces, make necessary 
changes, and retest the water to determine if your  changes were effective;  or treat the water in 
accordance with the requirements of § 112.43. 
(d) You may establish and use alternatives to  the requirements esta blished in paragraph 
(c) of this section, provided you sa tisfy the requirements of § 112.12. 
§ 112.45   How often must I test agricultural wate r that is subject to the requirements of § 
112.44?  
(a) You must test any agricultu ral water that is subject to  the requirements of § 112.44 at 
the beginning of each growing season, and ever y three months thereafter during the growing 
season, except that there is no re quirement to test water when: 
(1) You receive water from a Public Water Sy stem, 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 re gulations of a State approved to administer 
the SDWA public water supply program, and yo u have Public Water System results or 
certificates of compliance that demonstrat e that the water meets that requirement; 506 
 
(2) You receive water from a pub lic water supply that furnishes water that meets the microbial 
requirement described in § 112.44(a) , and you have public water system  results or certificates of 
compliance that demonstrate that the water meets that requirement; or (3) You treat water in accordance with the requirements of § 112.43.  
(b) If you use untreated surface water for purposes  that are subject to the requirements of 
§ 112.44, you must test the water as specifi ed in the table in this paragraph. 
If the untreated surface water is: Then you must test the untreated 
surface water: 
(1) From any source where a significant quantity of runoff is likely to drain 
into the source (for example, a river or natural lake) … At least every 7 days during the 
growing season 
(2) From any source where underground aquifer water is transferred to a 
surface water containment constructed and maintained in a manner that 
minimizes runoff drainage into the co ntainment (for exam ple, an on-farm 
man-made water reservoir) … At least once each month during the 
growing season 
 
§ 112.46  What measures must I take for water that I use during harvest, packing, and holding 
activities for covered produce?  
(a) You must manage the water as nece ssary, including by establishing and following 
water-change schedules for re-circulated water,  to maintain adequate sanitary quality and 
minimize the potential for contamination of co vered produce and food-c ontact surfaces with 
known or reasonably foreseeable hazards (for example, hazards that may be introduced into the water from soil adhering to the covered produce); 
(b) You must visually monitor the quality of  water that you use during harvest, packing, 
and holding activities for covered produce (for example, water used for washing covered produce 
in dump tanks, flumes, or wash tanks, and water used for cooling covered produce in hydrocoolers) for build-up of organic materi al (such as soil and plant debris). 
(c) You must maintain and monitor the temper ature of water at a temperature that is 
appropriate for the commodity and operation (cons idering the time and depth of submersion) and 507 
 
is adequate to minimize the potential for in filtration of microorgani sms of public health 
significance into covered produce. § 112.50  Under this subpart, what re quirements apply regarding records?
 
(a) You must establish and keep records requ ired under this subpart E in accordance with 
the requirements of subpart O of this part. 
(b) You must establish and keep the following records: 
(1) The findings of the inspecti on of your agricultural water system in accordance with the 
requirements of § 112.42(a);   (2) Documentation of the results of any anal ytical tests conducted to determine whether 
agricultural water is safe and of adequate sanitary quality for its intended use;   
(3)  Scientific data or information you rely on to support the adequacy  of a method used to 
satisfy the requirements of § 112.43(b) and (c)(1); (4) Documentation of the results of wate r treatment monitori ng under § 112.43(c)(2); 
(5) Documentation of the results of water test ing you perform to satisfy  the requirements of 
§112.44; and (6) Scientific data or information you rely on to support any alternativ e to the requirements 
established in § 112.44(c) for agricultural water used during growing activ ities using a direct 
water application method in accordance with the requirements of § 112.44(d).  (7) Annual documentation of the re sults or certificates of compliance from a public water system 
under 112.45(a)(1) or (a)(2 ), if applicable. 
Subpart F--Standards Directed to Biological So il Amendments of Animal Origin and Human 
Waste  508 
 
§ 112.51  What requirements apply for determining the status of a biologi cal soil amendment of 
animal origin?  
(a) A biological soil amendment of animal origin is treated if it has been processed to 
completion to adequately reduce microorganisms of public health significance in accordance 
with the requirements of § 112.54, or, in the case of  an agricultural tea, the biological materials 
used to make the tea have been so processed a nd the water used to make the tea satisfies the 
requirements of 112.44(a).   (b) A biological soil amendment of animal origin is untreated if it: (1) Has not been processed to completion in acco rdance 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 t ea does not satisfy the requirements of 112.44(a); 
(2) Has become contaminated after treatment;  (3) Has been recombined with an untreated biological soil amendment of animal origin; 
(4) Is or contains a component th at is untreated waste that you know  or have reason to believe is 
contaminated with a hazard or has been  associated with foodborne illness; or 
(5) Is an agricultural tea that co ntains an agricultural tea additive. 
§ 112.52  How must I handle, convey, and store bi ological soil amendments  of animal origin?
 
(a) You must handle, convey and store any biol ogical soil amendment of  animal origin in 
a manner and location such that it does not b ecome a potential source of contamination to 
covered produce, food-contact su rfaces, areas used for a covere d activity, water sources, and 
water distribution systems.  509 
 
(b) You must handle, convey and store any tr eated biological soil am endment of animal 
origin in a manner and location that minimizes the risk of it becoming contaminated by an 
untreated or in-process biological so il amendment of animal origin. 
(c) You must handle, convey, and store any bi ological soil amendment of animal origin 
that has become contaminated  as if it was untreated. 
§ 112.53  What prohibitions apply regarding use of human waste?  
You may not use human waste for growi ng covered produce, except sewage sludge 
biosolids used in accordance with the requirement s of 40 CFR part 503, subpa rt 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 ar e acceptable for a biological soil amendment 
of animal origin that you appl y in the growing of covered pro duce, provided that the resulting 
biological soil amendments are applied in acco rdance with the applicable requirements of § 
112.56: 
(a) A scientifically valid cont rolled physical process (for example, thermal), chemical 
process (for example, high alkali ne pH), or combination of sc ientifically valid controlled 
physical and chemical processes that  has been demonstrated to satis fy the microbial standard in § 
112.55(a) for Listeria  monocytogenes  (L. monocytogenes ), Salmonella  species, and E . coli  
O157:H7;  
(b) A scientifically valid controlled physical pr ocess, chemical process, or combination of 
scientifically valid controlled physical and chemi cal processes, that has been demonstrated to 
satisfy the microbial standard  in § 112.55(b) for Salmonella  and fecal coliforms; or  510 
 
(c) A scientifically valid controlled composti ng process that has been demonstrated to 
satisfy the microbial standard  in § 112.55(b) for Salmonella  and fecal coliforms.  Scientifically 
valid controlled composting processes include: (1) Static composting th at maintains aerobic (i.e., oxygenated)  conditions at a minimum of 131°F 
(55 °C) for 3 days and is followed by adequa te curing, which includes proper insulation;  
(2) Turned composting that maintains aerobic co nditions 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 (3) Other scientifically valid, controlled co mposting processes, provided you satisfy the 
requirements of § 112.12, including th at the alternative process has been demonstrated to satisfy 
the microbial standard in §112.55(b).  § 112.55  What microbial standards apply to the treatment pr ocesses in § 112.54?
 
The following microbial standards apply to the treatment processe s 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 or; 
For the microorganism: The microbial standard is: 
(1) L . monocytogenes  Not detected using a method that can detect one colony 
forming unit (CFU) per 5 gram analytical portion 
(2) Salmonella  species Less than three most probable numbers (MPN) per 4 
grams of total solids (dry weight basis) 
(3) E . coli  O157:H7 Less than 0.3 MPN per 1 gram analytical portion 
 
(b) Less than three MPN Salmonella  species per four grams of to tal solids (dry weight basis); 
and less than 1,000 MPN fecal coliforms per gr am of total solids (dry weight basis). 
§ 112.56  What application require ments and minimum application intervals apply to biological 
soil amendments of animal origin?  511 
 
(a) Except as provided in para graph (b) of this section, you must apply the biological soil 
amendments of animal origin specified in the fi rst column of the table in this paragraph in 
accordance with the application requirements specif ied in the second column of the table in this 
paragraph and the minimum application intervals specified in the third column of the table in this paragraph. 
If the biological soil amendment of 
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 ... 9 months 
(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 or chemical 
process, or combination of 
scientifically valid controlled physical 
and chemical processes, in accordance with the re quirements of  
§ 112.54(a) to meet the microbial 
standard in § 112.55(a) ... In any manner (i.e., no restrictions) ... 0 days 
(3) Treated by a scientifically valid 
controlled physical or chemical process, or combination of 
scientifically valid controlled physical 
and chemical processes, in 
accordance with the re quirements 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 
(4)(i) Treated by a composting 
process in accordance with the 
requirements of § 112.54(c) 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 ... 45 days 
(ii) Treated by a composting process 
in accordance with the requirements 
of § 112.54(c) to meet the microbial 
standard in § 112.55(b) ... In a manner that does not contact covered 
produce during or after application ... 0 days 
 
(b) You may establish and use alternatives  to the minimum application intervals 
established in paragraphs (a)( 1)(i) and (a)(4)(i) of this se ction, provided you satisfy the 
requirements of § 112.12.   512 
 
§ 112.60  Under this subpart, what re quirements apply regarding records?  
(a) You must establish and keep records requ ired under this subpart F in accordance with 
the requirements of subpart O of this part. 
(b) For any biological soil amendment of anim al origin you use, you must establish and 
keep the following records: (1) Documentation of the date of application of a ny untreated biological soil amendment of 
animal origin (including raw manur e) or any biological soil amendm ent of animal origin treated 
by composting to a growing area and the date of harvest of covered produce from that growing 
area, except when covered produce does not cont act the soil after application of the soil 
amendment;  (2) For a treated biological soil amendment of animal origin you receive from a third party, 
documentation (such as a Certif icate of Conformance) that: 
(i) The process used to treat th e biological soil amendment of anim al origin is a scientifically 
valid process that has been carried out with appropriate process monitoring;  
(ii) The applicable treatment process is periodica lly verified through testi ng using a scientifically 
valid analytical method on an adequately represen tative 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 ha ndled, conveyed and stored in a 
manner and location to minimize the risk of co ntamination by an untreated or in-process 
biological soil amendment of animal origin;    513 
 
(3) For a treated biological so il amendment of animal origin you produce for your own covered 
farm(s), documentation that proce ss controls (for example, time, temperature and turnings) were 
achieved;  (4) Scientific data or information you rely on to  support any alternative composting process used 
to treat a biological soil amendment of animal origin in accordance with the requirements of § 
112.54(c)(3); and (5) Scientific data or information you rely on to support any alternative minimum application 
interval in accordance with the requirements of § 112.56(b).  
Subpart G—[Reserved] Subpart H—[Reserved] Subpart I--Standards Directed to Domesticated and Wild Animals  
§ 112.81  How do the requirements of this subpart apply to areas where c overed activities take 
place?   
(a) The requirements of this subpart apply when a covered activity takes place in an 
outdoor area or a partially-encl osed building and when, under th e circumstances, there is a 
reasonable probability that animals will contaminate covered produce. 
(b) The requirements of this subpart do not apply when a covered activity takes place in a 
fully-enclosed building. § 112.82  What requirements apply regarding domesticat ed animals that I allow to graze in fields 
or use as working animals where I grow covered produce?  
At a minimum, if you allow animals to graze or use them as working animals in fields 
where covered produce is grown, and under the ci rcumstances there is a reasonable probability 514 
 
that grazing or working animals will contaminat e covered produce, you must take the following 
measures:  
(a) An adequate waiting period between gr azing and harvesting for covered produce in 
any growing area that was grazed to ensure the safety of the harvested crop; and  
(b) If working animals are used in a gr owing area where a crop has been planted, 
measures to prevent the introduction of known or  reasonably foreseeable hazards into or onto 
covered produce. § 112.83  What requirements appl y regarding animal intrusion?
 
(a) If under the circumstances there is a reason able probability that animal intrusion will 
contaminate covered produce, you must monitor t hose areas that are used for a covered activity 
for evidence of animal intrusion: 
(1) As needed during the growing season based on: 
(i) Your covered produce; and 
(ii) Your observations  and experience; and 
(2) Immediately prior to harvest. (b) If animal intrusion, as made evident by observation of signif icant quantities of 
animals, animal excreta or cr op destruction via grazing, occurs, you must evaluate whether the 
covered produce can be harvested in acco rdance with the requirements of § 112.112. 
Subpart J—[Reserved] Subpart K--Standards Directed to Growing, Harvesting, Packing, and Holding Activities 
§ 112.111  What measures must I take if I grow, ha rvest, pack or hold both covered and excluded 
produce?   515 
 
 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 co nduct such activities on covered produce, and 
the excluded produce is not grown, harvested, pack ed or held in accordance with this part, you 
must take measures during these cove red activities, as applicable, to: 
(a) Keep covered produce separate  from excluded produce; and  
(b) Adequately clean and sanitize, as necessary, any food-contact surfaces that contact excluded 
produce before using such food-contact surfaces  for covered activities on covered produce.  
§ 112.112  What measures must I take during harvest activities?  
You must take all measures reasonably neces sary 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 harves t covered produce that is visibly contaminated 
with animal excreta. § 112.113  How must I handle harvested co vered produce during covered activities?
 
 You must handle harvested covered produ ce in a manner that protects against 
contamination with known or reasonably foreseeab le hazards – for example, by avoiding contact 
of cut surfaces of harv ested produce with soil. 
§ 112.114  What requirements appl y to dropped covered produce?  
You must not distribute cove red produce that drops to th e ground before harvest (dropped 
covered produce) unless it is exempt under § 112.2(b). Dropped covered produce does not 
include root crops (such as car rots) that grow underground or crops (such as cantaloupe) that 
grow on the ground. § 112.115  What measures must I take  when packaging covered produce?
 516 
 
You must package covered produce in a ma nner that prevents the formation 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 us ing food-packing (including food packaging) 
material?  
(a) You must use food-packing material that is adequate for its intended use.  (b) If you reuse food-packing material, you must  take steps to ensure that food-contact 
surfaces are clean, such as by cleaning and sani tizing, when necessary, food-packing containers 
or using a clean liner.  Subpart L--Standards Directed to Equipm ent, Tools, Buildings, and Sanitation 
§ 112.121  What equipment and tools are subjec t to the requirements of this subpart?
 
Equipment and tools subject to the requireme nts of this subpart are those that are 
intended to, or likely to, contac t covered produce; and those instruments or controls used to 
measure, regulate, or record conditions to control or prevent the growth of undesirable 
microorganisms or other contamination.  Exampl es 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 ma terial, dump tanks, flumes, and vehicles or 
other equipment used for transport that are inte nded to, or likely to, contact covered produce). 
§ 112.122  What buildings are subject to  the requirements of this subpart?  
Buildings subject to the require ments of this subpart include: 
(a) Any fully- or partially-enclosed build ing used for covered activities, including 
minimal structures that have a r oof but do not have any walls; and 517 
 
(b) Storage sheds, buildings, or other structur es used to store food-contact surfaces (such 
as harvest containers an d food-packing materials). 
§ 112.123  What general requirements apply rega rding equipment and tools subject to this 
subpart?  
All of the following requirements apply rega rding equipment and t ools subject to this 
subpart: 
(a) You must use equipment and tools that  are of adequate design, construction, and 
workmanship to enable them to be adequa tely cleaned and properly maintained; and 
(b) Equipment and tools must be:  
(1) Installed and maintained as to facilitate cleaning of the equipment and of all adjacent 
spaces, and 
(2) Stored and maintained to  protect covered produce from being contaminated with 
known or reasonably foreseeable hazards and to pr event the equipment and tools from attracting 
and harboring pests. 
(c) Seams on food-contact surfaces of equipment and tools that you use must be either smoothly 
bonded, or maintained to minimize accumulation of  dirt, filth, food particles, and organic 
material and thus minimize the opportunity for harborage or growth of microorganisms.  
(d)(1) You must inspect, maintain, and clean and sanitize, when necessary and 
appropriate, all food-contact surf aces of equipment and tools us ed in covered activities as 
frequently as reasonably necessary to protec t against contamination of covered produce.  
(2) You must maintain and clean  all non-food-contact su rfaces of equipment and tools subject to 
this subpart used during harves ting, packing, and holding as freque ntly as reasonably necessary 
to protect against contamin ation of covered produce. 518 
 
(e) If you use equipment such as pallets, forklift s, tractors, and vehicles such that they are 
intended to, or likely to, contac t covered produce, you must do so in a manner that minimizes the 
potential for contamination of covered pr oduce or food-contact surfaces with known or 
reasonably foreseeable hazards. § 112.124  What requirements apply to instruments a nd controls used to measure, regulate, or 
record?  
Instruments or controls you use to measure,  regulate, or record  temperatures, hydrogen-
ion concentration (pH), sanitizer efficacy or other conditions, in or der to control or prevent the 
growth of undesirable microorganisms or other contamination, must be: 
(a) Accurate and precise as necessary and a ppropriate 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?  
Equipment that is subject to this subpart th at 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 design and construction requirements apply to my buildings?  
All of the following design and construction requirements apply regarding buildings. 
(a) Buildings must be suitable in size, construc tion, 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 r easonably foreseeable hazards. Buildings must: 519 
 
(1) Provide sufficient space for placement of equipment and storage of materials;  
(2) Permit proper precautions to be taken to reduce the potential for contamination of covered produce, food-contact surfaces, or packing materi als with known or reasonably foreseeable 
hazards. The potential for contamination must be reduced by effective design including the separation of operations in which contamination is likely to occur, by one or more of the 
following means: Location, time, partition, enclos ed systems, or other effective means; and 
(3) Be constructed in such a manner that floors,  walls, ceilings, fixtures, ducts and pipes can be 
adequately cleaned and kept in good repair, and that drip or condensate does not contaminate 
covered produce, food-contact su rfaces, or packing materials. 
 (b) You must provide adequate drainage in all areas where normal operations release or 
discharge water or other liquid waste on the ground or floor of the building. 
§ 112.127  What requirements apply regarding do mesticated animals in and around a fully-
enclosed building?    
(a) You must take reasonable precautions to  prevent contamination of covered produce, 
food-contact surfaces, and food-packing materials in fully-enclosed buildings with known or 
reasonably foreseeable hazards from domesticated animals by: (1) Excluding domesticated anim als from fully-enclosed buildings  where covered produce, food-
contact surfaces, or food-packing material is exposed; or (2) Separating domesticated animals in a fully en closed building from an area where a covered 
activity is conducted on covered produ ce 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 c ontamination of produce, food-contact surfaces, or 
food-packing materials. 520 
 
§ 112.128  What requirements apply rega rding pest contro l in buildings?   
(a) You must take those measures reasonabl y 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 bu ildings, 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?
 
All of the following requirements apply to toilet facilities: (a) You must provide personnel with adequa te, readily accessibl e toilet facilities, 
including toilet facilities readil y accessible to growing areas du ring harvesting ac tivities.    
(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 dist ribution systems with human waste;  
(2) Be directly accessible for servicing, be serviced and cleaned on a schedule sufficient to ensure suitability of us e, and be kept supplied with toilet paper; and 
(3) Provide for the sanitary disposal of waste and toilet paper. 
(c) During growing activities that take pl ace in a fully-enclosed building, and during 
covered harvesting, packing, or holding activities,  you must provide a hand-washing station in 
sufficiently close proximity to toilet facilities to  make it practical for pe rsons who use the toilet 
facility to wash their hands.  521 
 
§ 112.130  What requirements apply for hand-washing facilities?    
All of the following requirements apply to hand-was hing facilities: 
(a) You must provide personnel with adequate , readily accessible hand-washing facilities 
during growing activities that take place in a fu lly-enclosed building, and during covered harvest, 
packing, or holding activities.  
(b) Your hand-washing facilitie s 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  (3) Adequate drying devices (such as single servi ce towels, clean cloth towels or sanitary towel 
service). 
(c) You must provide for appropriate disposal  of waste (for example, waste water and 
used single-service towels) associated with a hand-washing facility and take appropriate 
measures to prevent waste water from a hand- washing facility from contaminating covered 
produce, food-contact surfaces, areas used for a covered activity, agricultural water sources, and 
agricultural water distribution systems with known or reasonab ly foreseeable hazards.   
(d) You may not use hand antiseptic/sanitizer or  wipes as a substitute for soap and water. 
§ 112.131  What must I do to cont rol and dispose of sewage?
 
All of the following requirements apply fo r the control and disposal of sewage: 
(a) You must dispose of sewage into an ad equate sewage or septic system or through 
other adequate means. 
(b) You must maintain sewage and septic systems in a manner that prevents 
contamination of covered produce, food-contact surfaces, areas used for a covered activity, 522 
 
agricultural water source s, and agricultural wate r distribution systems w ith known or reasonably 
foreseeable hazards. 
(c) You must manage and dispose of leakages or spills of human waste in a manner that 
prevents contamination of covered produce, and prevents or minimizes contamination of food-
contact surfaces, areas used for a covered activ ity, agricultural water sources, or agricultural 
water distribution systems.  
(d) After a significant event (such as flooding or an eart hquake) that could negatively 
impact a sewage or septic system, you must take  appropriate steps to en sure that sewage and 
septic systems continue to operate in a manner that does not contaminate covered produce, food-
contact surfaces, areas used for a covered activ ity, agricultural water sources, or agricultural 
water distribution 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 th e control and disposal of trash, litter, and 
waste in areas used for covered activities: 
(a) You must convey, store, and disp ose of trash, litter and waste to:  
(1) Minimize the potential for trash, litter, or  waste to attract or harbor pests; and  
(2) Protect against contaminati on of covered produce, food-cont act surfaces, areas used for a 
covered activity, agricultural water sources, and agricultural wa ter distribution systems with 
known or reasonably foreseeable hazards.   
(b) You must adequately operate systems for wa ste treatment and disposal so that they do 
not constitute a potential sour ce of contamination in areas used for a covered activity.  
§ 112.133  What requirements apply to plumbing?    523 
 
The plumbing must be of an adequate size and design and be adequately installed and 
maintained to: 
(a) Distribute water under pressure as needed, in sufficient quantities, in all areas where 
used for covered activities, for sanitary operations , or for hand-washing and toilet facilities.   
(b) Properly convey sewage and liquid disposable waste;  
(c) Avoid being a source of contamination to covered pr oduce, food-contact surfaces, 
areas used for a covered activity, or  agricultural water sources; and 
(d) Not allow backflow from, or cross conn ection between, piping systems that discharge 
waste water or sewage and piping systems that  carry water used for a covered activity, for 
sanitary operations, or for us e in hand-washing facilities. 
§ 112.134  What must I do to control animal excret a and litter from dome sticated animals that 
are under my control?  
(a) If you have domesticated animals, to pr event contamination of  covered produce, food-
contact surfaces, areas used for a covered activ ity, agricultural water sources, or agricultural 
water distribution systems with animal waste, you must:  
(1) Adequately control thei r excreta and litter; and  
(2) Maintain a system for contro l of animal excreta and litter. 
(b) [Reserved]  
§ 112.140  Under this subpart L, what re quirements apply regarding records?   
(a) You must establish and keep records requ ired under this subpart L in accordance with 
the requirements of subpart O of this part. 
(b) You must establish and keep documentati on of the date and method of cleaning and 
sanitizing of equipment subject  to this subpart used in: 524 
 
(1) Growing operations for sprouts; and 
(2) Covered harvesting, pack ing, or holding activities. 
Subpart M--Standards Directed to Sprouts  § 112.141  What requirements apply to seed s or beans used to grow sprouts?
 
In addition to the requirements of this part , all of the following requirements apply to 
seeds or beans used to grow sprouts. 
(a) If your farm grows seeds or beans for us e to grow sprouts, you must take measures 
reasonably necessary to prevent the introduction of  known or reasonably foreseeable hazards into 
or onto seeds or beans that you will use for sprouting.   
(b) If you know or have reas on to believe that a lot of seeds or beans have been 
associated with foodborne illness, you must not use that lot of seeds or beans to produce sprouts. 
(c) You must visually examine seeds and bean s, and packaging used to ship seeds or 
beans, for signs of potential contamination wi th known or reasonably foreseeable hazards.  
§ 112.142  What measures must I take for grow ing, harvesting, packing, and holding sprouts?  
You must take all of the following meas ures for growing, harvesting, packing, and 
holding sprouts: 
(a) You must grow, harvest, pack, and hol d sprouts in a fully-enclosed building.  
(b) Any food-contact surfaces you use to grow, harvest, pack, and hold sprouts must be 
cleaned and sanitized before cont act with sprouts or seeds or b eans used to grow sprouts.   
(c) You must treat seeds or beans that will be used to grow sprouts using a scientifically 
valid method immediately before sprouting to  reduce microorganisms of public health 
significance.  Prior treatment conducted by a grow er, handler, or distributor of seeds or beans 525 
 
does not eliminate your responsibility to treat se eds or beans immediately before sprouting at 
your covered farm. § 112.143  What testing must I do during growi ng, harvesting, packing, and holding sprouts?
 
All of the following testing must be done  during growing, harvesting, packing, and 
holding sprouts: 
(a) You must test the growing, harvesting, packing, and holding environment for Listeria  
species or L . monocytogenes  in accordance with the requirements of § 112.144.  
(b) You must either: 
(1) Test spent sprout irrigation water fr om each production batch of sprouts for E . coli  O157:H7 
and Salmonella  species in accordance with th e requirements of § 112.146; or  
(2) If testing spent sprout irrigation water is not practicable (for example, for soil-grown sprouts), 
test each production batch of spr outs at the in-process stage (i.e., while sprouts are still growing) 
for E . coli  O157:H7 and Salmonella  species in accordance with  the requirements of § 112.146. 
§ 112.144  What requirements apply to testing th e environment for Listeria species or L. 
monocytogenes?  
All of the following testing requirements appl y for the growing, harvesting, packing, and 
holding environment for Listeria  species or L . monocytogenes . 
(a) You must establish and implement a writte n environmental monitoring plan that is 
designed to identify L . monocytogenes  if it is present in the gr owing, 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.  526 
 
(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 envi ronmental samples, which must be no less than monthly; and 
(3) Sample collection sites; the number and loca tion of sampling sites must be sufficient to 
determine whether measures are effective and must include appropriate food-contact surfaces 
and non-food-contact surfaces of equipment, and other surfaces within the growing, harvesting, 
packing, and holding environment.   
(d) You must collect environmental samples and test them for Listeria  species or L . 
monocytogenes  according to the method in § 112.152.  
§ 112.145  What actions must I take if the grow ing, harvesting, packing, or holding environment 
tests positive for Listeria species or L . monocytogenes?  
You must take the following ac tions if you detect Listeria  species or L . monocytogenes  in 
the growing, harvesting, pack ing, or holding environment: 
(a) Conduct additional testing of surfaces and areas surround ing 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 affect ed surfaces and surrounding areas;  
(c) Conduct additional microbial sampling and testing to determine whether the Listeria  species 
or L. monocytogenes  has been eliminated; 
(d) Conduct finished product te sting when appropriate; and 
(e) Perform any other actions necessary to prevent reoccurrence of  the contamination.  
§ 112.146  What must I do to collect and test samples of spent sprout  irrigation water or sprouts?  527 
 
All of the following requirements apply for co llecting and testing samples of spent sprout 
irrigation water or sprouts: 
(a) You must establish and implement a writte n sampling plan that identifies the number 
and location of samples (of spent sprout irrigatio n water or sprouts) to be collected for each 
production batch of sprouts to en sure that the collected sample s are representative of the 
production batch when testing for contamination.  
(b) In accordance with the wr itten sampling plan required und er paragraph (a) of this 
section, you must aseptically collect  samples of spent sprout irriga tion water or sprouts, and test 
the collected samples for E . coli O157:H7 and Salmonella  species using a method that has been 
validated for its intended use (testing spent sprout irrigation water or sprouts) to ensure that the 
testing is accurate, precise, and se nsitive in detecti ng these pathogens. 
§ 112.150  Under this subpart, what re quirements apply regarding records?  
(a) You must establish and keep records requir ed under this subpart M in accordance with 
the requirements of subpart O of this part. 
(b) You must establish and keep the following records: 
(1) Documentation of your treatment of seeds or beans to reduce microorganisms of public 
health significance in the seed s or beans, at your farm; 
(2) Your written environmental monitoring plan  in accordance with the requirements of § 
112.144;  (3) Your written sampling plan for each producti on batch of sprouts in accordance with the 
requirements of § 112.146(a);  (4) The results of all testing conducted in accordance with the requirements of §§ 112.143 and 
112.144;  528 
 
(5) Any analytical methods you use in lieu of the methods that are incorporated by reference in 
§§ 112.152; and (6) The testing method you use in accord ance with the requirements of § 112.146(b). 
Subpart N--Analytical Methods § 112.151  What methods must I use to test the quali ty of water to satisfy the requirements of § 
112.45?    
(a) You must test the quality of water using a method of analysis: (1) As published in the “Official Methods of Analysis of the Association of Official 
Analytical Chemists (AOAC) International” (18t h ed., revision 4, 2011) wh ich is incorporated by 
reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51.  Copies are available from the 
AOAC International, 481 North Frederick Av e., suite 500, Gaithersburg, MD 20877, or at the 
National Archives and Records Administration (NAR A).  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/i br_locations.html; or
 
(2) As published in the Standards Methods fo r the Examination of Water and Wastewater 
(21st ed., 2005), American Public Health A ssociation (APHA), which is incorporated by 
reference in accordance with 5 U.S.C. 552(a) an d 1 CFR part 51.  You may obtain a copy from 
the APHA, 800 I St. NW., Washington, DC 20001, 202-777-2742.  You may inspect a copy at 
the Center for Food Safety and Applied Nutrit ion’s Library, 5100 Paint Branch Pkwy., College 
Park, MD 20740, 240-402-2163, or at the National Archives and Records Administration 
(NARA).  For information on the availability of  this material at NARA, call 202-741-6030, or go 
to http://www.archives.gov/federal_ register/code_of_federal_regul ations/ibr_locations.html; or  529 
 
(3) As prescribed in Chapter 4 of the F DA Bacteriological Analytical Manual (BAM) 
(Edition 8, Revision A, 1998), as up dated in June 2011.  The Direct or of the Federal Register 
approves the incorporation by reference of F DA’s BAM, Chapter 4 (Edition 8, Revision A, 
1998), as updated in June 2011, in accordance with  5 U.S.C. 552(a) and 1 CFR part 5.  You may 
obtain a copy of the method from Office of Re gulatory Science, Center for Food Safety and 
Applied Nutrition (CFSAN), Food and Drug Admi nistration, 5100 Paint Branch Pkwy., College 
Park, MD 20740, 240-402-1990, or you may examine a copy at CFSAN's Library, 5100 Paint 
Branch Pkwy., College Park, MD, 240-402-2163, or  at the National Archives and Records 
Administration (NARA).  For info rmation on the availability of this material at NARA, call 202–
741–6030, or go to:  http://www.archives.gov/federal_register/c ode_of_federal_regulat ion/ibr_locations.html
; or 
(4) That is at least equivale nt to the appropriate method of analysis in §§112.151(a)(1), 
(a)(2) or (a)(3) in accuracy, precision, and sensitivity. 
§ 112.152  What methods must I use to test the gr owing environment for Listeria species or L. 
monocytogenes to satisfy the requ irements of § 112.143(a) and § 112.144?  
You must test the growing environment by testing for the presence of Listeria  species or 
L. monocytogenes  in environmental samples using the methods and procedures described in 
Chapter 10 of FDA’s Bacteriological Analytic al Manual (BAM) April 2011, Edition (Edition 8, 
Revision A, 1998), or a method that is at least equivalent in accu racy, precision, and sensitivity.  
The Director of the Federal Re gister approves the incorporati on by reference of FDA’s BAM, 
Chapter 10--“Listeria  monocytogenes , Detection and Enumeration of Listeria  monocytogenes  in 
Foods,” April 2011, in accordance with 5 U.S.C. 552(a) and 1 CFR part 5.  You may obtain a copy of the method from Office of  Regulatory Science, Center for Food Safety and Applied 530 
 
Nutrition (CFSAN), Food and Drug Administra tion, 5100 Paint Branch Pkwy., College Park, 
MD 20740, 240-402-1990, or you may examine a copy at CFSAN's Library, 5100 Paint Branch Pkwy., College Park, MD, 240-402-2163, or at  the National Archives and Records 
Administration (NARA).  For inform ation on the availability of th is material at NARA, call 202-
741-6030, or go to:  http://www.archives.gov/federal_register/c ode_of_federal_regulat ion/ibr_locations.html
. 
Subpart O--Requirements Applying to Reco rds That You Must Establish and Keep 
§ 112.161  What general requirements appl y to records required under this part?  
(a) All records required under this part must: 
(1) Include, as applicable: (i) The name and location of your farm;  (ii) Actual values and observati ons obtained during monitoring;  
(iii) An adequate description (suc h as the commodity name, or the specific variety or brand name 
of a commodity, and, when available, any lot nu mber or other identifier) of covered produce 
applicable to the record;  (iv) The location of a growing ar ea (for example, a specific field) or other area (for example, a 
specific packing shed) appli cable to the record; and  
(v) The date and time of the activity documented;  
(2) Be created at the time an activ ity is performed or observed;  
(3) Be accurate, legible, and indelible; and (4) Be dated, and signed or initialed by th e person who performed the activity documented. 531 
 
(b) When records are required to be established and kept in s ubparts C, E, F, L, and M of 
this part (§§ 112.30, 112.50, 112.60, 112.140, and 112.150) , you must establish and keep 
documentation of actions you take when a st andard in those subpa rts is not met.  
(c)  Records required under §§ 112.50(b)(4), 112.50(b)(5), 112.60(b)(1), 1 12.60(b)(3), 112.140, 
112.150(b)(1), 112.150(b)(4), and 112.161(b), must be  reviewed, dated, and signed, within a 
reasonable time after the records are made, by a supervisor or responsible party.  
§ 112.162  Where must I store records?  
(a) Offsite storage of records is permitted after 6 months following the date the record 
was made if such records can be retrieved a nd provided onsite within 24 hours of request for 
official review.   
(b) Electronic records are considered to be ons ite at your farm if they are accessible from 
an onsite location at your farm. § 112.163  May I use existing records to sati sfy the requirements of this part?
 
Yes. The regulations in this part do not require d uplication of existing records if those 
records contain all of the info rmation required by this part.  
§ 112.164  How long must I keep records?  
(a) You must keep records required by this part  for 2 years past the date the record was 
created.  
(b) Records that relate to the general adequ acy of the equipment or processes being used 
by a farm, including the results of scientific studies  and evaluations, must be retained at the farm 
for at least 2 years after the use of such  equipment or processes is discontinued. 
§ 112.165  What formats are acceptable for the records I keep?  
You must keep records as: 532 
 
(a) Original records; 
(b) True copies (such as photoc opies, pictures, scanned copies , microfilm, microfiche, or 
other accurate reproductions of the original records); or  
(c) Electronic records, in complian ce with 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 a nd copying by FDA upon oral  or written request, 
except that you have 24 hours to obtain records you keep offsite and make them available and 
accessible to FDA for inspection and copying. 
(b) If you use electronic techniques to keep records, or to keep true copies of records, or 
if you use reduction techniques such  as microfilm to keep true copies of records, you must 
provide the records to FDA in a format in  which they are accessible and legible.  
(c) If your farm is closed for a prolonged pe riod, the records may be  transferred to some 
other reasonably accessible loca tion but must be returned to your farm within 24 hours for 
official review upon request. § 112.167  Can records that I provide to F DA be disclosed to persons outside FDA?
 
Records required by this part are subject to the disclosure requirements under part 20 of 
this chapter. Subpart P -- Variances  § 112.171  Who may request a variance from  the requirements of this part?
 
A State or a foreign country from which f ood is imported into the United States may 
request a variance from one or more requirements of  this part, where the State or foreign country 
determines that: 533 
 
(a) The variance is necessa ry in light of local growing conditions; and  
(b) The procedures, processes, and practi ces to be followed under the variance are 
reasonably likely to ensure that the produce is  not adulterated under se ction 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. § 112.172  How may a State or foreign country  request a variance from one or more 
requirements of this part?  
To request a variance from one or more requir ements of this part, the competent authority 
(e.g., the regulatory authority for food safety) fo r a State or a foreign country must submit a 
petition under § 10.30 of this chapter. § 112.173  What must be included in the Stat ement 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 reque sting a variance must: 
(a) Provide a statement that the applicable St ate or foreign country has determined that 
the variance is necessary in light  of local growing conditions and that the procedures, processes, 
and practices to be followed under the variance are reasonably likely to ensu re that the produce is 
not adulterated under section 402 of the Federa l Food, Drug and Cosmetic Act (21 U.S.C. 342) 
and to provide the same level of public health  protection as the requi rements of this part; 
(b) Describe with particularity the variance requested, including the persons to whom the 
variance would apply and the prov ision(s) of this part to wh ich the variance would apply; 
(c) Present information demonstrating that the procedures, processes, and practices to be 
followed under variance are reasona bly likely to ensure that the produce is not adulterated under 534 
 
section 402 of the Federal Food, Drug, and Cosme tic Act (21 U.S.C. 342) and to provide the 
same level of public health protectio n 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 submitted in a petition requesting a variance and 
comments submitted on such a petition, including a request that a variance be applied to its 
similarly situated persons, does not contain in formation exempt from public disclosure under 
part 20 of this chapter and would be made public as part of  the docket associated with this 
request.   § 112.175  Who responds to a peti tion requesting a variance?
 
The Director or Deputy Direct ors of the Center for Food Safety and Applied Nutrition 
(CFSAN), or the Director, Office of Compliance, CFSAN, responds to a request for a variance. 
§ 112.176  What process applies to a petition reques ting 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 granted (either because 
their farm is covered by the petition or as a pers on similarly situated to persons covered by the 
petition).  
(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 website a nnouncing our decision to either grant or deny 
the petition. 535 
 
(1)  If we grant the petition, either in whol e 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 deni als), our written response to the petitioner and 
our public notice announcing our de cision to deny the petition will explain the reason(s) for the 
denial. 
(d) We will make readily accessible to the public , and periodically update, a list of filed 
petitions requesting variances, including the st atus 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 
petition requesting that variance?  
(a) A State or a foreign country that belie ves that a variance requested by a petition 
submitted by another State or foreign country should also apply to similarly situated persons in 
its jurisdiction may request that the variance be  applied to its simila rly situated persons by 
submitting comments in accordance with § 10.30 of th is chapter.  These comments must include 
the information required in § 112.173.  If FDA dete rmines that these comments should instead be 
treated as a separate request for a variance, FD A will notify the State or foreign country that 
submitted these comments that a separate request must be submitted in accordance with §§ 112.172 and § 112.173.  
(b) If we grant a petition reque sting a variance, in whole or in part, we may specify that 
the variance also applies to persons in a specifi c location who are similarly situated to those 
identified in the petition. 
(c) If we specify that the variance also app lies to persons in a sp ecific location who are 
similarly situated to those identified in the petiti on, we will inform the applicable State or foreign 536 
 
country where the similarly situated persons are located of our decision in writing and will 
publish a notice on our website an nouncing our decision to appl y 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 required 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 th at the produce is not a dulterated 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 th e requirements of this part. 
§ 112.179  When does a variance approved by FDA become effective?  
A variance approved by FDA becomes effective the date of our written decision on the 
petition. § 112.180  Under what circumstances may FDA modify or revoke an approved variance?
 
We may modify or revoke a vari ance if we determine that such variance is not reasonably 
likely to ensure that the produce is not adul terated 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.  § 112.181  What procedures apply if FDA determin es that an approved variance should be 
modified or revoked?  
(a) We will provide the following notifications: (1) We will notify a State or a foreign country directly, in writing at the address identified 
in its petition, if we determine that a variance granted in response to its petition should be 537 
 
modified or revoked.  Our direct, written notifica tion will provide the State or foreign country 
with an opportunity to request an informal  hearing under part 16 of this chapter.  
(2) We will publish a notice of our determination that a variance should be modified or 
revoked in the Federal Register .  This notice will establish a public docket so that interested 
parties may submit written submissions on our determination.  
(3) When applicable, we will: (i) Notify in writing any States  or foreign countries where a variance applies to similarly 
situated persons of our determination that the variance should be m odified or revoked;  
(ii) Provide those States or foreign countries with an opportu nity to request an informal 
hearing under part 16 of this chapter; and 
(iii) Include in the Federal Register
 notice described in paragraph (a)(2) of this section 
public notification of our decision to modify or revoke the variance granted to States or foreign 
countries in which similarly situated persons are located. 
(b)  We will consider submissions from aff ected States or foreign countries and from 
other interested parties as follows:   (1)  We will consider requests for hearings  by affected States or foreign countries under 
part 16 of this chapter.  
(i)  If FDA grants a heari ng, we will provide the State or  foreign country with an 
opportunity to make an oral submission.  We w ill provide notice on our website of the hearing, 
including the time, date, and place of hearing.    (ii) If more than one State or foreign count ry requests an informal hearing under part 16 
of this chapter about our determ ination that a particular varian ce should be modified or revoked, 
we may consolidate such requests (for  example, into a single hearing). 538 
 
(2) We will consider written submissions submitted to the public docket from interested 
parties.  
(c)  We will provide notice of our final decision as follows: 
 (1)  On the basis of the administrative record, FDA will issue a written decision, as 
provided for under part 16 of this chapter.    (2)  We will publish a notice of our decision in the Federal Register
. The effective date of 
the decision will be the date of publication of the notice. 
§ 112.182  What are the permissible types of variances that may be granted?  
Examples of permissible t ypes of variances include: 
(a) Variance from the requirements, establis hed in § 112.44(c), when agricultural water is 
used during growing operations fo r covered produce (oth er than sprouts) using a direct water 
application method. 
(b) Variance from the process conditions, established in § 112.54(c)(1), for static 
composting;   
(c) Variance from the process conditions, established in § 112.54(c)(2), for turned 
composting;   
(d) Variance from the minimum application in terval, established in § 112.56(a)(1), for an 
untreated biological soil amendm ent of animal origin; and 
(e) Variance from the minimum application in terval, established in  § 112.56(a)(4), for a 
biological soil amendment of animal origin treat ed by a composting process in accordance with 
the requirements of § 112.54(c).  Subpart Q--Compliance and Enforcement § 112. 191  How do the criteria and definitions in this part apply? 
 539 
 
 The criteria and definitions in this pa rt apply in determining whether a food is 
adulterated:   (a) Within the meaning of section 402(a)(3 ) of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 342(a)(3)) in that the food has been grown, harveste d, packed, or held under such 
conditions that it is unfit for food; or   (b) Within the meaning of section 402(a)(4 ) of the Federal Food, Drug, and Cosmetic Act 
in that the food has been prepared, packed, or  held under insanitary conditions whereby it may 
have become contaminated with filth, or whereby it may have been rendered injurious to health.  
The criteria and definitions in this  part also apply in determining whether a food is in violation of 
section 361 of the Public Health  Service Act (42 U.S.C. 264). 
§ 112.192  What is the result of a fa ilure to comply with this part?
 
The failure to comply with the requirements of this part, issued under section 419 of the 
Federal Food, Drug, and Cosmetic Act (21 U. S.C. 350h), is a prohibited act under section 
301(vv) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 331(vv)). 
§ 112.193  What are the provisions for coordi nation of education and enforcement?  
Under Section 419(b)(2)(A) of the Federa l Food, Drug, and Cosmetic Act (21 U.S.C. 
350h(b)(2)(A)), FDA coordinates education and enforcement activ ities by State, Territorial, 
tribal, and local officials. Subpart R--Withdrawal of Qualified Exemption § 112.201  Under what circumstances can FDA w ithdraw a qualified exemption in accordance 
with the requirements of § 112.5?  
We may withdraw your qualified exemption under § 112.5: 540 
 
(a) In the event of an active inve stigation of a foodborne illness outbreak that is directly linked to 
your farm; or  (b) If we determine that it is necessary to pr otect the public health and prevent or mitigate a 
foodborne illness outbreak based on conduct or cond itions associated with your farm that are 
material to the safety of the food that woul d otherwise be covered produce grown, harvested, 
packed or held at your farm. § 112.202  What procedure will FDA use to withdraw an exemption?
 
(a) If FDA determines that  a qualified exemption applic able to a farm under § 112.5 
should be withdrawn, any officer or qualified employee of FDA may issue an order to withdraw 
the exemption.  
(b) An FDA District Director in  whose district the farm is located (or, in the case of a 
foreign farm, the Director of the Office of Comp liance in the Center for Food Safety and Applied 
Nutrition), or an FDA official se nior to such Director, must a pprove an order to withdraw the 
exemption.  
(c) FDA must issue an order to  withdraw the exemption to th e 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 qua lified exemption applicable to a farm under § 112.5 must 
include the following information:  
(a) The date of the order; (b) The name, address and location of the farm; 541 
 
(c) A brief, general statement of the reasons for the order, including information relevant 
to: (1) An active investigation of a f oodborne 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, harv ested, packed and held at such farm.   
(d) A statement that the farm must comply with subparts B through O of this part on the 
date that is 60 calendar days after the date of the order; 
(e) The text of section 419( f) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
350(f)) and of this subpart; 
(f) A statement that any informal hearing on an  appeal of the order must be conducted as 
a regulatory hearing under part 16 of this chapter, with certa in exceptions described in § 
112.208; 
(g) The mailing address, telephone number, emai l address, and facsimile number of the 
FDA district office and the name of the FDA Dist rict Director in whose district the farm is 
located (or for foreign farms, the same informa tion for the Director of the Office of Compliance 
in the Center for Food Safety and Applied Nutrition); and 
(h) The name and the title of the FDA representative who approved the order. 
§ 112.204  What must I do if I receive an order to  withdraw a qualified ex emption 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: 542 
 
(a) Comply with applicable requirements of this part within 60 calendar days of the date of the 
order or, if operations have ceased and will not  resume within 60 calendar days, before the 
beginning of operations in the next growing season; or  (b) Appeal the order within 10 cal endar days of the date of th e 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 submi ssion of a request for an informal hearing, 
will not operate to delay or stay any administ rative action, including enforcement action by FDA, 
unless the Commissioner of Food a nd Drugs, as a matter of discretion, determines that delay or a 
stay is in the public interest. 
(b) If the owner, operator, or agent in char ge of the farm appeals the order, and FDA 
confirms the order, the owner, operator, or ag ent in charge of the farm must comply with 
applicable requirements of this part within 60 ca lendar days of the date of the order, or, if 
operations have ceased and will not resume within 60 calendar days, before the beginning of operations in the next growing season.  § 112.206  What is the procedure for submitting an appeal?
 
(a) To appeal an order to withdraw a qualif ied 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 for Food 
Safety and Applied Nutrition), at the mailing address, e-mail address, or facsimile number 
identified in the order within 10 calenda r days of the date of the order; and 543 
 
(2)  Respond with particularity to the facts a nd issues contained in the order, including any 
supporting documentation upon which the owner, operato r or agent in charge of the farm relies. 
(b) In a written appeal of the order wi thdrawing an exemption provided under § 112.5, 
the owner, operator, or agent in charge of the fa rm may include a written request for an informal 
hearing as provided in § 112.207.   § 112.207  What is the procedure for requesting an informal hearing?
 
(a) If the owner, operator, or agent in charge of the farm appeals the order, the owner, 
operator, or agent in charge of the farm: (1) May request an informal hearing; and  (2) Must submit any request for an informal hearing together with its written appeal submitted in accordance with § 112.206 within 10 calendar days of the date of the order. 
(b) A request for an informal hearing may be de nied, 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 determ ines 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 appli cable to an informal hearing?
 
If the owner, operator or agent in charge of  the farm requests an informal hearing, and 
FDA grants the request:  
(a) The hearing will be held within 10 calendar days after the date the appeal is filed or, if 
applicable, within a timef rame agreed upon in writing by the owner, operator, or agent in charge 
of the farm and FDA.  544 
 
(b) The presiding officer ma y require that a hearing c onducted under this subpart be 
completed within 1 calendar day, as appropriate.  
(c) FDA must conduct the heari ng in accordance with part 16 of  this chapter, except that: 
(1) The order withdrawing an exemption unde r § 112.5, rather than th e notice under § 16.22(a) 
of this chapter, provides notice of opportunity for a hearing under this sec tion and is part of the 
administrative record of the regulatory h earing under § 16.80(a) of this chapter.  
(2) A request for a hearing under this subpart must be addressed to the FDA District Director (or, 
in the case of a foreign farm, the Director of  the Office of Compliance in the Center for Food 
Safety and Applied Nutrition) as provided in the order withdraw ing an exemption.  
(3) Section 112.209, rather than § 16.42(a) of this chapter, de scribes 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 h earing 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 pres iding officer must include as part of the report 
of the hearing a finding on the credibility of witn esses (other than expert witnesses) whenever 
credibility is a material  issue, and must include a proposed decision, with a statement of reasons. 
The hearing participant may review and commen t on the presiding officer's report within 2 
calendar days of issuance of the report. The presiding officer will then issue the final decision.   
(5) Section 16.80(a)(4) of th is chapter does not apply to a regu latory hearing under this subpart.  
The presiding officer’s report of the hearing and any comments on th e 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 offi cer’s final decision.  545 
 
(7) If FDA grants a request for an informal h earing on an appeal of an  order withdrawing an 
exemption, the hearing must be conducted as a regulatory hearing under re gulation 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 h earing under this subpart , the administrative r ecord of the hearing 
specified in §§ 16.80(a)(1), (a)(2), (a)(3), a nd (a)(5), and § 112.208(c )(5) constitutes the 
exclusive record for the presiding officer’s final decision.  Fo r purposes of judicial review 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 fo r 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 fa rm appeals the order without 
requesting a hearing, the presidi ng officer must issue a writte n report that includes a final 
decision confirming or revoking the w ithdrawal by the 10th calendar day af ter the appeal is filed.   
(b) If the owner, operator, or agent in charge  of a farm appeals the order and requests an 
informal hearing:  (1) If FDA grants the request for a hearing and the hearing is held, the presiding officer must 
provide a 2 calendar day opportunity  for the hearing participants to review and submit comments 
on the report of the hearing under § 112.208(c)(4), and must issue a final decision within 10 
calendar days after the hearing is held; or 546 
 
(2) If FDA denies the request for a hearing, the presiding officer must issue a final decision on 
the appeal confirming or revoking the withdrawal within 10 cale ndar days after the date the 
appeal is filed.  § 112.211  When is an order to withdraw a qualif ied exemption applicable to a farm revoked?
 
An order to withdraw a qualif ied exemption applicable to a farm under § 112.5 is revoked 
if: 
(a) The owner, operator, or agent in charge of the farm appeals th e order and requests an 
informal hearing, FDA grants the request for an informal hearing, and the presiding officer does 
not confirm the order within the 10 calendar days after the heari ng, or issues a decision revoking 
the order within that time; or  
(b) The owner, operator, or agent in charge of the farm appeals th e order and requests an 
informal hearing, FDA denies the request for an  informal hearing, and FDA does not confirm the 
order within the 10 calendar days  after the appeal is filed, or issues a decision revoking the order 
within that time; or 
(c) The owner, operator, or agent in char ge of the farm app eals the order without 
requesting an informal hearing, and FDA does not confirm the orde r within the 10 calendar days 
after the appeal is filed, or issues a deci sion revoking the order within that time.  
(d) Confirmation of a withdrawal order by th e presiding officer is considered a final 
Agency action for purposes of 5 U.S.C. 702.  Dated: January 3, 2013. Leslie Kux, Assistant Commissioner for Policy. 547 
 
 
 [FR Doc. 2013-00123 Filed 01/04/2013 at 11: 15 am; Publication Date: 01/16/2013]