3504 Federal Register / Vol. 78, No. 11 / Wednesday, January 16, 2013 / Proposed Rules 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Parts 16 and 112 

[Docket No. FDA–2011–N–0921] 

RIN 0910–AG35 

Standards for the Growing, Harvesting, 

Packing, and Holding of Produce for 

Human Consumption 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Proposed rule. 

SUMMARY: To minimize the risk of 

serious adverse health consequences or 

death from consumption of 

contaminated produce, the Food and 

Drug Administration (FDA) is proposing 

to establish science-based minimum 

standards for the safe growing, 

harvesting, packing, and holding of 

produce, meaning fruits and vegetables 

grown for human consumption. FDA is 

proposing these standards as part of our 

implementation of the FDA Food Safety 

Modernization Act (FSMA). These 

standards would not apply to produce 

that is rarely consumed raw, produce for 

personal or on-farm consumption, or 

produce that is not a raw agricultural 

commodity. In addition, produce that 

receives commercial processing that 

adequately reduces the presence of 

microorganisms of public health 

significance would be eligible for 

exemption from the requirements of this 

rule. The proposed rule would set forth 

procedures, processes, and practices 

that minimize the risk of serious adverse 

health consequences or death, including 

those reasonably necessary to prevent 

the introduction of known or reasonably 

foreseeable biological hazards into or 

onto produce and to provide reasonable 

assurances that the produce is not 

adulterated on account of such hazards. 

We expect that the proposed rule, if 

finalized as proposed, would reduce 

foodborne illness associated with the 

consumption of contaminated produce. 

DATES: Submit either electronic or 

written comments on the proposed rule 

by May 16, 2013. Submit comments on 

information collection issues under the 

Paperwork Reduction Act of 1995 by 

February 15, 2013 (see the ‘‘Paperwork 

Reduction Act of 1995’’ section of this 

document). 

ADDRESSES: You may submit comments, 

identified by Docket No. FDA–2011–N– 

0921 and/or Regulatory Information 

Number RIN 0910–AG35, by any of the 

following methods, except that 

comments on information collection 

issues under the Paperwork Reduction 

Act of 1995 must be submitted to the 

Office of Regulatory Affairs, Office of 

Management and Budget (OMB) (see the 

‘‘Paperwork Reduction Act of 1995’’ 

section of this document). 

Electronic Submissions 

Submit electronic comments in the 

following way: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the 

instructions for submitting comments. 

Written Submissions 

Submit written submissions in the 

following ways: 

• Mail/Hand delivery/Courier (for 

paper or CD–ROM submissions): 

Division of Dockets Management (HFA– 

305), Food and Drug Administration, 

5630 Fishers Lane, rm. 1061, Rockville, 

MD 20852. 

Instructions: All submissions received 

must include the Agency name and 

Docket No. FDA–2011–N–0921 and 

Regulatory Information Number RIN 

0910–AG35 for this rulemaking. All 

comments received may be posted 

without change to http:// 

www.regulations.gov, including any 

personal information provided. For 

additional information on submitting 

comments, see the ‘‘Comments’’ heading 

of the SUPPLEMENTARY INFORMATION

section of this document. 

Docket: For access to the docket to 

read background documents or 

comments received, go to http:// 

www.regulations.gov and insert the 

docket number(s), found in brackets in 

the heading of this document, into the 

‘‘Search’’ box and follow the prompts 

and/or go to the Division of Dockets 

Management, 5630 Fishers Lane, rm. 

1061, Rockville, MD 20852. 

FOR FURTHER INFORMATION CONTACT: 

Samir Assar, Center for Food Safety and 

Applied Nutrition (HFS–317), Food and 

Drug Administration, 5100 Paint Branch 

Pkwy., College Park, MD 20740, 240– 

402–1636. 

SUPPLEMENTARY INFORMATION: 

Table of Contents 

Executive Summary 

Proposed Rule 

I. Introduction 

A. Contamination With Microbiological 

Hazards 

B. Contamination With Chemical, Physical 

or Radiological Hazards 

II. Efforts To Address Produce Safety 

A. Inspections and Investigations 

B. Guidance Documents and Letters to 

Industry 

C. Produce Safety Action Plan 

D. Public Hearings 

E. Partnerships and Collaborations 

F. Current Industry Practices 

G. 2010 Federal Register Notice and 

Preliminary Stakeholder Comments 

H. White House Food Safety Working 

Group 

I. Other Related Issues 

III. Legal Authority 

A. Section 105 of FSMA and Section 419 

of the FD&C Act 

B. Other Provisions of the FD&C Act 

C. The Public Health Service Act 

D. Legal Authority for Records 

Requirements 

E. Intrastate Activities 

F. Relevance of Section 415 of the FD&C 

Act to ‘‘Farm’’ Definition and Related 

Definitions 

IV. Regulatory Approach 

A. Qualitative Assessment of Risk 

B. Focus on Biological Hazards 

C. Consideration of Differing Risk of 

Different Commodities and Practices 

D. Framework of the Rule 

E. Records 

F. Farm-specific Food Safety Plans 

G. Foreign Farms 

H. Consistency With Codex Guidelines 

I. Product Testing as a Strategy to Control 

Pathogens 

J. Effective Dates 

K. Compliance Dates 

V. The Proposal 

A. Subpart A—General Provisions 

B. Subpart B—General Requirements 

C. Subpart C—Standards Directed to 

Personnel Qualifications and Training 

D. Subpart D—Standards Directed to 

Health and Hygiene 

E. Subpart E—Standards Directed to 

Agricultural Water 

F. Subpart F—Standards Directed to 

Biological Soil Amendments of Animal 

Origin and Human Waste 

G. Reserved 

H. Reserved 

I. Subpart I—Standards Directed to 

Domesticated and Wild Animals 

J. Reserved 

K. Subpart K—Standards Directed to 

Growing, Harvesting, Packing and 

Holding Activities 

L. Subpart L—Standards Directed to 

Equipment, Tools, Buildings, and 

Sanitation 

M. Subpart M—Standards Directed to 

Sprouts 

N. Subpart N—Analytical Methods 

O. Subpart O—Requirements Applying to 

Records That You Must Establish and 

Keep 

P. Subpart P—Variances 

Q. Subpart Q—Compliance and 

Enforcement 

R. Subpart R—Withdrawal of Qualified 

Exemption 

VI. Preliminary Regulatory Impact Analysis 

VII. Analysis Of Environmental Impact 

VIII. Federalism 

IX. Comments 

X. References 

Executive Summary 

The FDA Food Safety Modernization 

Act (FSMA) (Pub. L. 111–353) requires 

FDA to publish a notice of proposed 

rulemaking to establish science-based 

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Federal Register / Vol. 78, No. 11 / Wednesday, January 16, 2013 / Proposed Rules 3505 

minimum standards for the safe 

production and harvesting of those 

types of fruits and vegetables that are 

raw agricultural commodities for which 

we have determined such standards 

minimize the risk of serious adverse 

health consequences or death. Further, 

new section 419 also requires FDA to 

adopt a final regulation based on known 

safety risks, setting forth procedures, 

processes, and practices that we 

determine to minimize the risk of 

serious adverse health consequences or 

death, including those that are 

reasonably necessary to prevent the 

introduction of known or reasonably 

foreseeable hazards into produce and to 

provide reasonable assurances that 

produce is not adulterated under section 

402 of the FD&C Act. 

This proposed rule focuses on 

microbiological hazards related to 

produce growing, harvesting, packing, 

and holding. We conducted a ‘‘Draft 

Qualitative Assessment of Risk to Public 

Health from On-Farm Contamination of 

Produce’’ and considered the findings of 

this assessment in developing this 

proposed rule. While we acknowledge 

the potential for chemical, physical or 

radiological contamination of produce, 

for reasons discussed in this proposed 

rule, we are not proposing specific 

standards for these hazards in this 

rulemaking. 

Scope of Coverage of the Proposed Rule 

The proposed rule would apply to 

both domestic and imported produce. 

However, as explained in the remainder 

of this document, the proposed rule 

contains several exemptions: 

• The proposed rule would not apply 

to certain specified produce 

commodities that are rarely consumed 

raw. 

• The proposed rule also would not 

apply to produce that is used for 

personal or on-farm consumption, or 

that is not a raw agricultural 

commodity. 

• The proposed rule would provide 

an exemption for produce that receives 

commercial processing that adequately 

reduces the presence of microorganisms 

(e.g. a ‘‘kill step’’) as long as certain 

documentation is kept. 

• The proposed rule would not cover 

farms that have an average annual value 

of food sold during the previous threeyear period of $25,000 or less. 

• The proposed rule would provide a 

qualified exemption and modified 

requirements for farms that meet two 

requirements: (1) The farm must have 

food sales averaging less than $500,000 

per year during the last three years; and 

(2) the farm’s sales to qualified endusers must exceed sales to others. A 

qualified end-user is either (a) the 

consumer of the food or (b) a restaurant 

or retail food establishment that is 

located in the same State as the farm or 

not more than 275 miles away. Instead, 

these farms would be required to 

include their name and complete 

business address either on the label of 

the produce that would otherwise be 

covered (if a label is required under the 

FD&C Act and its implementing 

regulations) or at the point-of-purchase. 

This exemption may be withdrawn in 

the event of an active investigation of an 

outbreak that is directly linked to the 

farm, or if it is necessary to protect the 

public health and prevent or mitigate an 

outbreak based on conduct or 

conditions on the farm that are material 

to the safety of the produce. As 

explained in the Preamble, these entities 

are either exempt from all the 

requirements of the rule or are subject 

to a narrower set of requirements. 

Summary of the Major Provisions of the 

Regulatory Action 

The proposed rule would establish 

science-based minimum standards for 

the safe growing, harvesting, packing, 

and holding of produce on farms. We 

propose new standards in the following 

major areas: 

• Worker Training and Heath and 

Hygiene 

Æ Establish qualification and 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); 

Æ Require documentation of required 

training (proposed § 112.30); and 

Æ Establish hygienic practices and 

other measures needed to prevent 

persons, including visitors, from 

contaminating produce with 

microorganisms of public health 

significance (proposed §§ 112.31, 

112.32, and 112.33). 

• Agricultural Water 

Æ Require that all agricultural water 

must be of safe and sanitary quality for 

its intended use (proposed § 112.41). 

Agricultural water is defined in part as 

water that is intended to, or likely to, 

contact the harvestable portion of 

covered produce or food-contact 

surfaces (proposed § 112.3(c)); 

Æ Establish requirements for 

inspection, maintenance, and follow-up 

actions related to the use of agricultural 

water, water sources, and water 

distribution systems associated with 

growing, harvesting, packing, and 

holding of covered produce (proposed 

§§ 112.42 and 112.46); 

Æ 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); 

Æ Establish specific requirements for 

the quality of agricultural water that is 

used for certain specified purposes, 

including provisions requiring periodic 

analytical testing of such water (with 

exemptions provided for use of public 

water supplies under certain specified 

conditions or treated water), and 

requiring certain actions to be taken 

when such water does not meet the 

quality standards (proposed §§ 112.44 

and 112.45); and provide for alternative 

requirements for certain provisions 

under certain conditions (proposed 

§ 112.12); and 

Æ Require certain records, including 

documentation of inspection findings, 

scientific data or information relied on 

to support the adequacy of water 

treatment methods, treatment 

monitoring results, water testing results, 

and scientific data or information relied 

on to support any permitted alternatives 

to requirements (proposed § 112.50). 

• Biological Soil Amendments 

Æ Establish requirements for 

determining the status of a biological 

soil amendment of animal origin as 

treated or untreated, and for their 

handling, conveying, and storing 

(proposed §§ 112.51, 112.52) 

Æ Prohibit the use of human waste for 

growing covered produce except in 

compliance with EPA regulations for 

such uses or equivalent regulatory 

requirements (proposed § 112.53); 

Æ 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 alternative 

requirements for certain provisions 

under certain conditions (proposed 

§ 112.12); 

Æ Establish application requirements 

and minimum application intervals for 

untreated and treated biological soil 

amendments of animal origin (proposed 

§ 112.56); and provide for alternative 

requirements for certain provisions 

under certain conditions (proposed 

§ 112.12); and 

Æ Require certain records, including 

documentation of application and 

harvest dates relevant to application 

intervals; documentation from suppliers 

of treated biological soil amendments of 

animal origin, periodic test results, and 

scientific data or information relied on 

to support any permitted alternatives to 

requirements (proposed § 112.60). 

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3506 Federal Register / Vol. 78, No. 11 / Wednesday, January 16, 2013 / Proposed Rules 

• Domesticated and Wild Animals 

Æ If animals are allowed to graze or 

are used as working animals in fields 

where covered produce is grown and 

under the circumstances there is a 

reasonable probability that grazing or 

working animals will contaminate 

covered produce, require, at a 

minimum, an adequate waiting period 

between grazing and harvesting for 

covered produce in any growing area 

that was grazed, and measures to 

prevent the introduction of known or 

reasonably foreseeable hazards into or 

onto covered produce (proposed 

§ 112.82); and 

Æ If under the circumstances there is 

a reasonable probability that animal 

intrusion will contaminate covered 

produce, require monitoring of those 

areas that are used for a covered activity 

for evidence of animal intrusion 

immediately prior to harvest and, as 

needed, during the growing season 

(proposed § 112.83). 

• Equipment, Tools, and Buildings 

Æ Establish requirements related to 

equipment and tools that contact 

covered produce and instruments and 

controls (including equipment used in 

transport), buildings, domesticated 

animals in and around fully-enclosed 

buildings, pest control, hand-washing 

and toilet facilities, sewage, trash, 

plumbing, and animal excreta (proposed 

§§ 112.121–134); and 

Æ Require certain records related to 

the date and method of cleaning and 

sanitizing equipment used in growing 

operations for sprouts, and in covered 

harvesting, packing, or holding 

activities (proposed § 112.140). 

• Sprouts 

Æ Establish measures that must be 

taken related to seeds or beans for 

sprouting (proposed § 112.141); 

Æ Establish measures that must be 

taken for the growing, harvesting, 

packing, and holding of sprouts 

(proposed § 112.142); 

Æ Require that you test the growing 

environment for Listeria spp. or L. 

monocytogenes and that you test each 

production batch of spent irrigation 

water or sprouts for E. coli O157:H7 and 

Salmonella species and take appropriate 

follow-up actions (proposed §§ 112.143, 

112.144, 112.145, 112.146); and 

Æ Require certain records, including 

documentation of your treatment of 

seeds or beans for sprouting, a written 

environmental monitoring plan and 

sampling plan, test results, and certain 

methods used (proposed § 112.150). 

As proposed, the effective date is 60 

days after a final rule is published, 

however, we are providing for a longer 

timeline for farms to come into 

compliance. Small businesses (i.e., 

those subject to proposed part 112 and, 

on a rolling basis, the average annual 

monetary value of food sold during the 

previous three-year period is no more 

than $500,000) would have three years 

after the effective date to comply; for 

some of the water requirements, they 

would have five years. In addition, very 

small businesses (i.e., those subject to 

proposed part 112 and, on a rolling 

basis, the average annual monetary 

value of food sold during the previous 

three-year period is no more than 

$250,000) would have four years after 

the effective date to comply; for some of 

the water requirements, they would 

have six years. All other farms would 

have two years after the effective date to 

comply; for some of the water 

requirements, they would have four 

years to comply. 

Costs and Benefits 

The baseline estimate for preventing 

all illnesses associated with microbial 

contamination of produce covered by 

this proposed regulation is $1.6 billion; 

however, we do not expect that we will 

eliminate all illnesses associated with 

covered produce. Instead, we expect 

that the proposed produce safety 

regulation will prevent some portion of 

this illness burden from recurring. We 

estimate the number of foodborne 

illness prevented by this regulation to 

be 1.75 million, with an associated 

benefit of $1.04 billion, annually. As 

described in the Preliminary Regulatory 

Impact Analysis (PRIA), making a 

precise estimate of the rule’s likely 

effectiveness is extremely difficult, 

because FDA has only limited data that 

would establish a clear baseline 

estimate of how contamination occurs 

and the likely impact of the proposed 

provisions on that baseline, with respect 

to causing human illness. We estimate 

the costs of the proposed rule to be 

$459.56 million annually for domestic 

farms, $170.62 million annually for 

foreign farms covered by the rule (for a 

grand total of $630.18 million annually), 

resulting in $406.22 million annually in 

estimated potential net benefits. 

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 

1As described in detail in the PRIA, data to estimate the costs and benefits of this rule are limited. Best estimates were made for both the 

costs and the benefits of the rule, given the data available. We request comment on these estimations, and request, in particular, data related to 

the amount of contamination attributable to each potential pathway of contamination, the relative effectiveness of each provision at reducing contamination, and data related to current industry food safety practices. 

Proposed Rule 

I. Introduction 

Each year, about 48 million 

Americans (1 in 6) get sick, 128,000 are 

hospitalized, and 3,000 die from 

foodborne diseases, according to 

estimates from the Centers for Disease 

Control and Prevention. The FDA Food 

Safety Modernization Act (FSMA) (Pub. 

L. 111–353), signed into law by 

President Obama on January 4, 2011, 

enables FDA to better protect public 

health by helping to ensure the safety 

and security of the food supply. FSMA 

enables us to focus more on preventing 

food safety problems rather than 

primarily reacting to problems after they 

occur. The law also provides us with 

new enforcement authorities to help us 

achieve higher rates of compliance with 

prevention- and risk-based safety 

standards and to better respond to and 

contain problems when they do occur. 

In addition, the law gives us important 

new tools to better ensure the safety of 

imported foods and directs us to build 

an integrated national food safety 

system in partnership with State and 

local authorities. 

Section 105 of FSMA adds section 

419 to the Federal Food, Drug, and 

Cosmetic Act (FD&C Act) (21 U.S.C. 

350h) requiring FDA to publish a notice 

of proposed rulemaking to establish 

science-based minimum standards for 

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Federal Register / Vol. 78, No. 11 / Wednesday, January 16, 2013 / Proposed Rules 3507 

the safe production and harvesting of 

those types of fruits and vegetables that 

are raw agricultural commodities for 

which we have determined such 

standards are necessary to minimize the 

risk of serious adverse health 

consequences or death. Further, new 

section 419 also requires FDA to adopt 

a final regulation based on known safety 

risks, setting forth procedures, 

processes, and practices that we 

determine to minimize the risk of 

serious adverse health consequences or 

death, including those that are 

reasonably necessary to prevent the 

introduction of known or reasonably 

foreseeable hazards into produce and to 

provide reasonable assurances that 

produce is not adulterated under section 

402 of the FD&C Act. This proposed rule 

sets forth such standards, as well as 

certain exemptions from the standards, 

consistent with section 419 of the FD&C 

Act. 

Two additional proposed rules, with 

the produce safety proposed rule, will 

be the foundation of, and central 

framework for, a new food safety system 

in the United States. In an 

accompanying notice in this issue of the 

Federal Register, FDA is publishing the 

preventive controls proposed rule that 

would apply to human food and require 

domestic and foreign facilities that are 

required to register under the FD&C Act 

to have written plans that identify 

hazards, specify the steps that will be 

put in place to minimize or prevent 

those hazards, monitor results, and act 

to correct problems that arise. 

FDA also intends to publish the 

foreign supplier verification program 

(FSVP) proposed rule, which would 

help ensure the safety of foods imported 

into the U.S. by making importers 

accountable for verifying that the food 

they import is produced using processes 

and procedures that achieve the same 

level of public health protection for 

imported food as required of domestic 

growers and processors under FSMA’s 

new standards for produce safety and 

preventive controls. 

Eating fruits and vegetables is an 

important part of a healthy diet (Ref. 1). 

FDA is responsible for ensuring the 

safety of all domestic and imported 

fruits and vegetables consumed in the 

United States. We place a high priority 

on identifying and implementing 

measures that can reduce the incidence 

of foodborne illness associated with 

produce and maintain a high level of 

consumer confidence in this important 

food category. Produce is vulnerable to 

contamination with microorganisms of 

public health significance (e.g., bacteria 

and viruses that can cause disease), as 

well as chemical, physical, and 

radiological contaminants. 

Contamination of produce can occur onfarm during growing (either in an open 

environment or in a fully- or partiallyenclosed building), harvesting, packing, 

or holding; or elsewhere along the farmto-table continuum. 

A. Contamination With Microbiological 

Hazards 

American consumers enjoy one of the 

safest supplies of produce in the world. 

Over the last few decades, however, 

problems linked to produce, including 

the associated public health 

implications, have been reported in a 

number of countries worldwide. Many 

factors affect the occurrence of 

microbial contamination of fresh 

produce, including worker health and 

hygiene, the quality of agricultural 

water, the use of animal manure and 

other materials of animal origin as 

fertilizer, the presence of wild or 

domestic animals in or near fields or 

packing areas, growing and harvesting 

operations, and equipment and building 

sanitation. As discussed in more detail 

below, FDA has taken several steps to 

help reduce the likelihood of microbial 

contamination; significant advances 

have been made. However, in spite of 

these efforts, produce-associated 

foodborne illnesses continue. 

FDA has looked specifically at 

outbreaks where the point of 

contamination is likely to have 

happened early in the production chain, 

during growing, harvesting, 

manufacturing, processing, packing, 

holding, or transportation (Ref. 2). Of 

the total reported outbreaks and 

outbreak-related illnesses linked to 

FDA-regulated foods between 1996 and 

2010, in the FDA database, produce 

accounted for 23.3% and 42.3%, 

respectively. Both domestic produce 

and imported produce were identified 

as vehicles in these outbreaks. From 

1996 to 2010, approximately 131 

produce-related reported outbreaks 

occurred, resulting in 14,132 outbreakrelated illnesses, 1,360 hospitalizations 

and 27 deaths. These outbreaks were 

associated with approximately 20 

different fresh produce commodities 

(Ref. 3). Commodities associated with 

outbreaks during this time period 

included sprouts; leafy greens such as 

lettuce and spinach; tomatoes; melons 

such as cantaloupe and honeydew; 

berries such as raspberries, blueberries, 

blackberries, and strawberries; fresh 

herbs such as basil and parsley; and 

green onions as well as fresh-cut fruits 

and vegetables. FDA also has evidence 

that contamination occurs on some 

produce crops at least intermittently 

based on sampling performed as part of 

investigation, inspections, and FDA 

Domestic and Import Field Assignments 

and data from United States Department 

of Agriculture (USDA)’s Agricultural 

Marketing Service (AMS) 

Microbiological Database program 

(MDP) (Ref. 4 Ref. 5). For instance, in 

2009, AMS tested eight types of produce 

for E. coli O157:H7, non-O157 E. coli 

carrying shiga toxin and enterotoxin 

genes, and Salmonella. MDP identified 

51 samples with E. coli carrying shiga 

toxin genes; however only 24 of these 

were determined to be pathogenic. MDP 

identified 32 samples with Salmonella 

confirmed by culture. The USDA AMS 

MDP was discontinued in 2012 and 

FDA is evaluating options for any future 

collection of similar microbiological 

data. 

The following commodities accounted 

for 88.5% of the total produceassociated outbreaks: 

• 34 outbreaks associated with 

sprouts, 

• 30 outbreaks associated with leafy 

greens such as lettuce and spinach 

• 17 outbreaks associated with 

tomatoes 

• 14 outbreaks associated with 

melons such as cantaloupe and 

honeydew 

• 10 outbreaks associated with 

berries, such as raspberries, blueberries, 

blackberries and strawberries 

• 6 outbreaks associated with fresh 

herbs such as basil and parsley 

• 3 outbreaks associated with green 

onions. 

(Ref. 2) 

In the FDA database, fresh-cut fruits 

and vegetables accounted for 16.8% of 

the total produce-related outbreaks. 

Generally, the most likely point of 

original contamination for the fresh-cutrelated outbreaks, as determined by 

FDA and its federal and state partners 

during the outbreak investigations, 

appears to be during growing, harvest, 

packing or holding, while the 

commodity is still in its raw agricultural 

commodity (RAC) form, rather than 

during manufacturing/processing of the 

fresh-cut product (Ref. 2). In a few 

instances, such as unwashed, field 

packed tomatoes being removed from a 

warm ripening room and placed in cold 

water to firm for slicing (which may 

have promoted infiltration of pathogens) 

(Ref. 6), it is possible that practices or 

conditions at the fresh-cut facility 

contributed to the contamination event. 

It is possible that the way product is 

handled during processing, including 

mixing large batches of fresh-cut 

product, may spread contamination 

across a larger volume of product, 

impacting the size and scope of an 

outbreak associated with fresh-cut 

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3508 Federal Register / Vol. 78, No. 11 / Wednesday, January 16, 2013 / Proposed Rules 

produce. However, there have also been 

a number of very large outbreaks 

associated with RACs. 

Pathogens associated with the 

produce outbreaks include bacteria, 

viruses and parasites. Between 1996 and 

2010, the majority of fresh producerelated outbreaks and illnesses in the 

FDA database were associated with 

bacterial agents (86.5%), followed by 

parasites (11.6%) and viruses (1.9%). 

These outbreaks involved a number of 

pathogens, including E. coli O157:H7, E. 

coli O157, Salmonella species 

(Salmonella spp.), Listeria 

monocytogenes (L. monocytogenes), 

Cyclospora, Shigella sonnei, and 

Hepatitis A. 

In an accompanying document titled 

‘‘Draft Qualitative Assessment of Risk to 

Public Health from On-Farm 

Contamination of Produce,’’ FDA has 

conducted a qualitative assessment of 

risk associated with growing, 

harvesting, packing, and holding of 

produce (hereafter referred to as the 

Qualitative Assessment of Risk (QAR)). 

In particular, the QAR is intended to 

address various risk management 

questions related to biological hazards 

of concern in fresh produce that can 

lead to serious adverse health 

consequences or death; potential routes 

of contamination; and the likelihood of 

contamination and likelihood of illness 

attributable to consumption among 

various types of produce commodities. 

The findings of this qualitative 

assessment of risk informed our 

regulatory approach and several 

proposed provisions. We provide a 

summary of the findings in section IV; 

additionally, we refer to the QAR 

throughout this proposed rule, 

including the discussion of proposed 

provisions in section V of this 

document. 

B. Contamination With Chemical, 

Physical or Radiological Hazards 

Chemical contaminants of produce 

can originate from a variety of sources. 

Most common among these include soil 

(through previous chemical exposure), 

equipment (e.g., lubricants, fuels, and 

refrigerants), pesticides, insecticides 

and related agents, and cleaning 

compounds (e.g., sanitizers) normally 

used in the course of maintaining 

buildings and equipment. FDA monitors 

chemical and pesticide residues in 

foods through its regulatory monitoring 

programs with emphasis on raw 

agricultural commodities (RACs) and 

foods consumed by infants and 

children. Illnesses attributable to 

chemical hazards are rare (Ref. 7). In 

fact, between 1997 and 2011, there have 

been no Class I recalls of produce 

associated with a chemical hazard for 

which there is a reasonable probability 

of causing serious health problems or 

death (Ref. 8). Current monitoring, 

regulations, and industry practice have 

been sufficient to keep these hazards 

under control. 

Similarly, the potential public health 

consequences of physical hazard 

contamination (e.g. glass or metal 

fragments) in produce appear to be 

relatively (Ref. 7). Rarely do the 

physical hazards associated with 

produce suggest a risk of serious adverse 

health consequences or death for 

individuals that would consume the 

product. In fact, between 1997 and 

2011, there have been no Class I recalls 

of produce associated with a physical 

hazard for which there is a reasonable 

probability of causing serious health 

problems or death (Ref. 8). 

The presence of radiological hazards 

in foods is a rare event and consumer 

exposure to harmful levels of 

radionuclide hazards, outside of 

catastrophic events, is very low (Ref. 7. 

Ref. 9). 

While we acknowledge the potential 

for chemical, physical or radiological 

contamination of produce, based on our 

analysis (Ref. 7), and for the reasons 

discussed in section IV.B of this 

document, we are not proposing specific 

standards for these hazards in this 

rulemaking. 

II. Efforts to Address Produce Safety 

FDA and others have taken a number 

of actions to address produce safety in 

the last two decades. This section 

describes several of these activities up 

to and including FSMA. 

A. Inspections and Investigations 

We have conducted a number of 

inspections and investigations that have 

provided useful information about the 

routes of contamination. Investigations 

involved visiting multiple field 

locations and packing operations. 

Observations during the investigations 

revealed several areas of farm practices 

that seem most likely to have been 

possible routes of contamination for 

produce involved in the outbreaks. Our 

inspections, investigations, and 

surveillance sampling activities are 

described in more detail in 

accompanying documents. 

B. Guidance Documents and Letters to 

Industry 

1. GAPs Guide 

On October 2, 1997, President Clinton 

announced the ‘‘Initiative to Ensure the 

Safety of Imported and Domestic Fruits 

and Vegetables’’ (Produce and Imported 

Food Safety Initiative or PIFSI). As part 

of this initiative, the President directed 

the Secretary of the Department of 

Health and Human Services (HHS) and 

the Secretary of the U.S. Department of 

Agriculture (USDA), in cooperation 

with the agricultural community, to 

issue guidance on good agricultural 

practices (GAPs) for fresh fruits and 

vegetables. In October, 1998, we issued 

final guidance to industry entitled 

‘‘Guide to Minimize Microbial Food 

Safety Hazards for Fresh Fruits and 

Vegetables’’ (GAPs Guide) (Ref. 10). 

This guide contains voluntary 

recommendations for good agricultural 

practices (GAPs) that growers and 

packers can undertake to address 

common factors contributing to 

contamination in their operations. The 

GAPs Guide is a broad scope guidance 

that takes into account the diversity of 

conditions and practices associated with 

the growing, harvesting, packing and 

holding of fresh produce. We noted that 

firms should use the general 

recommendations in the GAPs Guide to 

tailor practices to their individual 

operations. As the GAPs Guide notes, 

current technologies cannot eliminate 

all potential food safety hazards 

associated with fresh produce that will 

be eaten raw. Therefore, the focus of the 

GAPs Guide is on implementing 

measures to minimize the potential for 

introduction of such hazards. 

On September 2, 2008, we issued a 

notice in the Federal Register (73 FR 

51306) requesting comments and 

scientific data and information to assist 

us in improving the GAPs Guide. We 

specifically asked for information about 

(1) current agricultural practices and 

conditions used to produce, harvest, 

pack, cool, and transport fresh produce; 

(2) risk factors for contamination of 

fresh produce associated with these 

practices; and (3) possible 

recommendations or additional 

measures that would enhance the safety 

of fresh produce. We also requested 

information about the estimated costs 

and benefits of current practices and/or 

the cost and benefits of any 

recommendations. We received 

approximately two dozen submissions 

from organizations and individuals, 

including: Industry, government, 

universities, environmental groups, 

consumers, and consumer groups. A 

number of comments discussed the 

value of performing operational 

assessments, developing food safety 

plans and record keeping but suggested 

that any updated guidance acknowledge 

that these activities should be 

commensurate with the complexity of 

an operation and associated risks. Other 

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comments requested additional 

information on microbial testing to 

ensure that when testing is done it is 

meaningful and cost effective. 

2. Letters to Lettuce, Tomato, and 

Cilantro Industries 

On February 5, 2004, we issued a 

letter to firms that grow, harvest, pack 

or hold fresh lettuce and fresh tomatoes, 

expressing concern regarding outbreaks 

of foodborne illness associated with the 

consumption of these products, and 

recommending actions to enhance the 

safety of these products (Ref. 11). On 

November 4, 2005, we issued a second 

letter to firms that grow, harvest, pack, 

hold or manufacture/process fresh and 

fresh-cut lettuce, reiterating concerns 

about continuing outbreaks (Ref. 12). In 

the November 2005 letter, we strongly 

encouraged applicable firms to review 

their current operations in light of the 

GAPs Guide, as well as other available 

information regarding the reduction or 

elimination of pathogens on fresh 

produce. We encouraged firms to 

consider modifying their operations to 

ensure that they were taking the 

appropriate measures to provide a safe 

product to the consumer. We 

recommended that firms from the farm 

level through the distribution level 

undertake these steps. 

In March, 2011, we issued a letter to 

firms that grow, harvest, pack or hold 

fresh cilantro, expressing concern about 

positive sample findings and 

recommending actions to enhance the 

safety of these products (Ref. 13). 

Between 2004 and March, 2011, there 

had been 28 confirmed Salmonella 

positive sample results in fresh cilantro 

in, or entering into, commerce. Samples 

were of both U.S. and imported origin. 

As with earlier letters to the industry, 

we strongly encouraged applicable firms 

to review their current operations in 

light of the GAPs Guide, as well as other 

available information regarding the 

reduction or elimination of pathogens 

on fresh produce. We encouraged firms 

to consider modifying their operations 

to ensure that they were taking the 

appropriate measures to provide a safe 

product to the consumer. In addition, 

we encouraged these firms to assess 

hazards unique to the production of 

cilantro and to develop commodityspecific preventive control strategies. 

We recommended that firms from the 

farm level through the distribution level 

undertake these steps. 

3. Guidances and Letters Regarding 

Sprouts 

On October 27, 1999, we published a 

notice of availability (64 FR 57893) for 

two guidance documents to inform all 

parties involved in the production of 

sprouts (i.e., producers, conditioners, 

and distributors of seeds and beans used 

for sprouting, sprout producers) that 

sprouts have been recognized as an 

important cause of foodborne illness 

and to provide recommendations for 

preventive controls that we believed 

should be taken immediately to reduce 

the likelihood of sprouts serving as a 

vehicle for foodborne illness (Ref. 

14).(Ref. 15) The first guidance 

document, ‘‘Reducing Microbial Food 

Safety Hazards for Sprouted Seeds’’ (the 

Sprout Guide), provides 

recommendations based on the 

recommendations of the National 

Advisory Committee on Microbiological 

Criteria for Foods (NACMCF) (Ref. 16). 

We also released a second guidance, 

‘‘Sampling and Microbial Testing of 

Spent Irrigation Water During Sprout 

Production’’ (the Sprout Testing Guide), 

to assist sprouters in implementing one 

of the principal recommendations in the 

broader Sprout Guide, i.e., that 

producers test spent irrigation water for 

two pathogens (Salmonella spp. and E 

coli O157:H7) before product enters 

commerce. We refer to these guidances 

collectively as the Sprout Guides. 

On April 22, 2005, we announced in 

the Federal Register (70 FR 20852) a 

public meeting to elicit information on 

current science related to foodborne 

illness associated with the consumption 

of sprouts. The meeting notice 

contained a series of questions to help 

focus comments, including questions 

regarding: (1) Practices that may 

contribute to contamination of seeds 

used for sprouting and intervention 

strategies that could help prevent, 

reduce, or control contamination of 

seeds used for sprouting; (2) Whether 

the preventive controls recommended in 

our Sprout Guides could be improved 

and, if so, how this might be done; (3) 

What can or should be done to increase 

the involvement of producers of seeds 

for sprouting and seed distributors to 

ensure the safety of sprouts; (4) How, if 

at all, should the actions to improve the 

safety of seeds for sprouting be 

structured to take into account variation 

within the seed and sprout industry, 

including variations in size of 

establishments, the types of seeds and 

sprouts produced and the practices used 

in production; and (5) Existing food 

safety systems or standards (such as 

international standards) that we should 

consider as part of our efforts to 

minimize foodborne illness associated 

with the consumption of sprouts. 

In general, comments expressed a 

need to include the seed industry, as 

well as the sprout industry, in efforts to 

improve the safety of sprouts. Several 

comments stated that any 

recommendations should be 

scientifically sound, based on 

appropriate (and feasible) expectations 

for risk reduction, and be easy to 

understand and implement. Comments 

expressed concern about the effect on 

worker health of treating seed with 

20,000 ppm calcium hypochlorite. 

Comments were generally supportive of 

recommendations in the Sprout Guides 

to test spent irrigation water; several 

comments supported expanded testing, 

including seed testing by seed 

producers and distributors. All but one 

comment maintained that seeds were 

the primary source of contamination in 

sprout-associated outbreaks. Several 

comments discussed practices and 

conditions, such as animal grazing, 

which could contaminate seed in the 

field. One comment suggested the 

industry develop a GAPs guidance 

specific to the production of seed for 

use in sprouts. Several comments 

supported applying Current Good 

Manufacturing Practices (CGMPs) (21 

CFR Part 110) to sprout facilities. A 

number of comments cited the diversity 

of sprout types currently being 

produced and noted this diversity of 

products is likely to continue to grow. 

These comments maintained it was 

therefore appropriate to provide 

flexibility for individual operations to 

select mitigations appropriate for the 

products they produce. Comments to 

the 2005 Sprout Public Meeting were 

considered in this rulemaking and will 

be further described when we discuss 

proposed provisions specific to sprouts 

in section V.M. of this document. 

On May 1, 2009, we issued a letter to 

suppliers and distributors of seeds and 

beans used for sprouting, and sprouters, 

to make firms aware of our serious 

concerns with continuing outbreaks 

associated with the consumption of raw 

and lightly cooked sprouts and to urge 

firms to review their operations in light 

of our Sprout Guides and other available 

information (Ref. 17), and to modify 

their operations accordingly to ensure 

they are taking appropriate measures to 

provide a safe product to consumers. 

We also shared a May 1, 2008, letter 

from the California Department of 

Public Health (CDPH) to the California 

sprout industry outlining several critical 

areas of concern identified in recent 

investigations and CDPH 

recommendations for controlling 

hazards associated with those 

observations (Ref. 18). 

4. Draft Commodity Specific Guidances 

On August 3, 2009, we published a 

notice in the Federal Register 

announcing the availability for public 

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comment of draft commodity specific 

guidances (CSGs) for melons (74 FR 

38437), tomatoes (74 FR 38438) and 

leafy greens (74 FR 38439). The draft 

CSGs are intended for growers, packers, 

processors, transporters, retailers, and 

others throughout the supply chain. The 

draft CSGs, if finalized, would provide 

a framework for identifying and 

implementing appropriate measures to 

minimize the likelihood of microbial 

contamination of tomatoes, leafy greens, 

and melons. The draft CSGs reflect both 

commodity specific information, such 

as recommendations for tomato 

repacking, and advances in collective 

thinking in broader areas, such as 

assessing potential hazards in and near 

the field before beginning production 

and immediately before harvest, and 

protecting and maintaining water 

quality at its source and during 

distribution and use. The draft CSGs are 

designed to complement our GAPs 

Guide and Fresh-cut Guide. On 

November 4, 2009, we published a 

notice in the Federal Register, 

extending to January 4, 2010, the 

comment period on the draft CSGs. We 

have not yet issued these guidances in 

final form. 

In developing the draft CSGs, we 

relied heavily on existing industry 

commodity specific guidelines, our 

produce safety initiatives and programs, 

lessons learned from outbreak 

investigations, and other public and 

private programs. We have since 

received several dozen written 

comments, from industry, States, and 

individuals. Comments were generally 

supportive of the scope and objectives 

of the draft CSGs. Comments provided 

their views on both commodity specific 

issues (e.g., recommendations for field 

packing tomatoes, water quality for 

rehydrating leafy greens after harvest) 

and cross-cutting issues (e.g., 

management of wild animal intrusion, 

quality of water used in postharvest 

operations). A number of comments 

requested that we recognize different 

risks may be associated with different 

commodities within the commodity 

groups covered by the CSGs, noting, for 

example, that cantaloupe (not 

watermelon) have been identified as the 

vehicle in the majority of foodborne 

illness outbreaks associated with 

melons. A number of comments 

expressed concern about potential bias 

of the CSG approach (i.e., separate 

recommendations for different 

commodities) against small farms 

growing a diversity of crops, especially 

the concern that the CSG approach 

could require such farms to have 

multiple food safety plans to cover each 

of the commodities they grow. 

Additional comments will be discussed 

when we describe proposed provisions 

relevant to those comments. 

5. Guidances Regarding Nuts 

On March 11, 2009, we published a 

notice in the Federal Register (74 FR 

10598) announcing the availability for 

public comment of draft guidance for 

industry: Measures to Address the Risk 

for Contamination by Salmonella 

Species in Food Containing a PeanutDerived Product as an Ingredient. 

Additionally, on June 29, 2009, we 

published a notice in the Federal 

Register (74 FR 310308) announcing the 

availability for public comment of draft 

guidance for industry: Measures to 

Address the Risk for Contamination by 

Salmonella Species in Food Containing 

a Pistachio-Derived Product As An 

Ingredient. These draft guidance 

documents were intended for 

manufacturers who use a peanutderived product or pistachio-derived 

product as an ingredient in a food 

product. These draft guidances provide 

recommendations for evaluating the 

effectiveness of certain Salmonella 

control measures. We have not yet 

issued these guidances in final form. 

6. Fresh-cut Guide 

On March 6, 2006, we published a 

notice in the Federal Register (71 FR 

11209) announcing the availability on 

our Web site of a draft Guidance for 

Industry entitled ‘‘Guide to Minimize 

Microbial Food Safety Hazards of Freshcut Fruits and Vegetables’’ (the Freshcut Guide). We received a number of 

comments from trade associations, 

consumer groups, and industry. 

Comments were generally supportive of 

the draft Guide. A few comments 

included questions about our draft 

definition of fresh-cut produce and 

whether the recommendations in the 

draft guidance were mandatory or 

voluntary, in light of the mandatory 

requirements in existing CGMPs. 

On February 25, 2008, we published 

a notice (73 FR 10037) announcing our 

finalization and the availability of our 

‘‘Guide to Minimize Microbial Food 

Safety Hazards of Fresh-cut Fruits and 

Vegetables’’ (the Fresh-cut Guide). The 

Fresh-cut Guidance complements the 

CGMPs in 21 CFR, Part 110 and 

provides recommendations for a 

framework for identifying and 

implementing appropriate measures to 

minimize the likelihood of microbial 

contamination during the processing of 

fresh-cut produce. Examples of 

recommendations for fresh-cut 

processors in the Fresh-cut Guidance 

include: (1) Know your suppliers and 

have a mechanism to verify that your 

suppliers use good agricultural 

practices, good manufacturing practices, 

and other appropriate food safety 

practices; and (2) ensure equipment is 

designed to prevent water collection. 

While fresh-cut produce is not covered 

under the scope of this proposed rule, 

we include a reference to our guidance 

on fresh-cut produce as some of the 

measures recommended in that 

document are relevant to the 

requirements proposed for covered 

produce in this rule. 

B. Produce Safety Action Plan 

On June 15, 2004, we published a 

Federal Register notice (69 FR 33393) 

announcing a public meeting to elicit 

information from stakeholders 

concerning key elements of a draft 

produce safety action plan entitled 

‘‘Produce Safety From Production to 

Consumption: An Action Plan to 

Minimize Foodborne Illness Associated 

With Fresh Produce’’ (the Produce 

Safety Action Plan or PSAP). We posted 

the draft PSAP on June 18, 2004 (Ref. 

19). The draft PSAP continued the 1997 

Produce and Imported Food Safety 

Initiative, building on experience from 

earlier efforts such as the development 

and implementation of the GAPs Guide, 

inspections of farms and produce 

packing facilities, surveillance sampling 

assignments, and investigations of 

foodborne illness outbreaks. The draft 

PSAP addressed all principal points 

between the farm and table where 

contamination of produce could occur. 

It covered fresh fruit and vegetables in 

their native (RAC) form and raw, 

minimally processed products (i.e., 

fresh-cut produce) that have received 

some processing to alter their form but 

have not been subject to a thermal 

process that would eliminate microbial 

hazards. The draft PSAP was not 

intended to cover processed products 

such as juice, or agricultural products 

other than fruits and vegetables. 

After considering comments received 

from various stakeholders, in October 

2004, we issued the final PSAP. In 

recognition that contamination of 

produce can happen at any point in the 

supply chain, the PSAP expands on the 

areas covered by the GAPs Guide (i.e., 

farms and packing houses) to extend to 

all parts of the food supply chain from 

farm through retail or consumer 

preparation and consumption. The 

PSAP does not cover frozen fruits and 

vegetables, fruit and vegetable juices, or 

nuts. The PSAP has four main 

objectives: (1) Prevent contamination of 

fresh produce with pathogens; (2) 

minimize the public health impact 

when contamination of fresh produce 

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occurs; (3) improve communication 

with producers, packers, processors, 

transporters, distributors, preparers, 

consumers, and other government 

entities about the safety of fresh 

produce; and (4) facilitate and support 

research relevant to the contamination 

of fresh produce. For each objective, the 

PSAP identifies steps or actions that 

could contribute to the achievement of 

that objective. The PSAP has 

measurable goals and outcomes, and 

several steps outlined in the PSAP are 

already in progress or have been 

completed. For example, we issued the 

Fresh-cut Guide and provided technical 

assistance to industry efforts to develop 

commodity specific supply chain 

guidance as part of the PSAP objective 

regarding prevention of contamination. 

C. Public Hearings 

On February, 27, 2007, we published 

a notice (72 FR 8750) of two public 

hearings, and request for comment, on 

the safety of fresh produce. In that 

notice, we stated that we believe that 

the measures outlined in the PSAP, the 

GAPs Guide, and other public and 

private sector actions, when 

implemented, can be effective in 

reducing the likelihood of microbial 

contamination of fresh produce. 

However, the fact that outbreaks of 

foodborne illness associated with fresh 

produce continue to occur supports the 

need for a close examination of: The 

extent to which these measures have 

been implemented; whether they have 

been effective when implemented 

properly; and, what additional or 

different interventions might be 

appropriate to reduce the likelihood of 

future outbreaks. 

We held the public hearings to share 

information about recent outbreaks of 

foodborne illness associated with 

microbial contamination of fresh 

produce, and to invite comments, data, 

and other scientific information about: 

Current practices used to grow, harvest, 

pack, hold, manufacture/process, and 

transport fresh produce; risk factors for 

contamination of fresh produce 

associated with these practices; and 

measures FDA could take to enhance 

the safety of fresh produce. The notice 

of hearings included a list of issues and 

questions to help focus comments and 

asked for scientific information and 

data. We received approximately 48 

submissions from industry, government, 

universities, environmental groups, 

consumers, and consumer groups. 

Recurring comments included: The 

importance of activities to promote or 

enhance rapid, accurate traceback; 

strengthened coordination and 

communication between all sectors (i.e., 

researchers, regulators, and industry) on 

available science and current 

unpublished data; and an integrated, 

multidisciplinary approach to identify 

best practices not currently incorporated 

by industry. A number of comments 

expressed concerns about the cost of 

third party audits and lack of 

standardization of such audits. 

Comments also indicated a desire for 

training. Comments were divided on 

whether we should continue to promote 

adoption of voluntary GAPs guidance or 

pursue rulemaking to establish 

mandatory requirements. Comments 

supporting mandatory requirements 

differed on what these requirements 

should look like; suggestions ranged 

from mandatory GAPs to a Hazard 

Analysis and Critical Control Point 

(HACCP)-like approach, or a 

combination of the two. Comments were 

in general agreement that, whatever 

regulatory approach was chosen, it 

should be consistent across the United 

States, based on sound science, and 

cover a broad range of commodities 

while being flexible enough to 

accommodate the needs of specific 

commodities, regions, operations, 

practices, and different sizes of 

operations. 

D. Partnerships and Collaborations 

1. Public and Private Standards 

Because the GAPs Guide is voluntary, 

FDA and food safety partners in the 

public and private sectors have 

emphasized education and outreach to 

industry to promote adoption of the 

guidance. Buyer requirements that 

producers and other suppliers provide 

self- or third party audit verification that 

they are following the GAPs Guide have 

further promoted adoption of the 

guidance. We have worked with the 

fresh produce industry since the release 

of the GAPs Guide to promote its 

recommendations and to advance the 

scientific knowledge applicable to 

enhancing the safety of fresh produce. 

For example, in conjunction with the 

PSAP, we have provided technical 

assistance to industry in developing 

several industry commodity specific 

guidelines that cover the entire supply 

chain, including commodity-specific 

guidelines for melons, leafy greens, 

tomatoes, and green onions; these 

commodities together accounted for 70 

percent of the foodborne outbreaks 

associated with produce between 1998 

and 2009 (Ref. 3). These industry 

guidelines were in turn helpful to us in 

developing FDA’s draft commodity 

specific guidances for the same 

commodities (see section II.B.4 of this 

document). Additional industry 

guidelines have been developed or are 

in progress for a broad range of 

commodities, including: strawberries, 

mushrooms, watermelon, potatoes, 

storage onions, and citrus. 

We provided technical assistance to 

the Association of Food and Drug 

Officials (AFDO) to formulate a Model 

Code of Practice for the Production of 

Fresh Fruits and Vegetables (the Model 

Code) (Ref. 20). This work grew out of 

a request from the tomato industry in 

late 2006 to address outbreaks of 

foodborne illness attributed to fresh 

tomatoes. However, the AFDO Board 

believed that it was also important to 

address GAPs in the production of a 

broader range of fresh fruits and 

vegetables. Thus, AFDO convened a 

working group to develop a Model Code 

for produce safety during growing, 

harvesting, packing and holding that 

could be considered as a model for 

guidance and/or regulation by Federal 

and State regulatory bodies, and for 

collaboration among such parties and 

the industry. The Model Code does not 

address the additional processing steps 

that may occur at a fresh-cut or other 

processing facility, which is covered by 

the CGMPs in 21 CFR part 110. The 

Model Code focuses on minimizing the 

potential for contamination of fresh 

produce with pathogens. 

Through cooperative agreement with 

Cornell University, FDA has, together 

with USDA AMS, established a jointly 

funded Produce Safety Alliance (PSA), 

based on the successful Seafood HACCP 

Alliance for Training and Education. 

The PSA is a public-private partnership 

that will develop and disseminate 

science- and risk-based training and 

education programs to provide produce 

farms with fundamental food safety 

knowledge, starting in advance of this 

proposed rule and continuing after the 

final rule is promulgated. The PSA 

includes active participation from the 

produce industry and academic 

institutions nationwide. The curriculum 

development process has already 

started, through establishment of topicspecific working committees charged 

with identifying challenges to 

understanding and implementing GAPs 

on farms. This first phase of work, in 

advance of a final rule, is intended to 

assist farms, especially small farms, in 

establishing appropriate food safety 

measures, consistent with the GAPs 

Guide and other existing guidances, so 

that they will be better positioned when 

we issue a final rule establishing 

produce safety standards under section 

419 of the FD&C Act. As this rulemaking 

progresses, the PSA materials will be 

modified, as needed, to be consistent 

with the requirements in the rule. 

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2. Foodborne Illness Investigations— 

Environmental Assessment Model 

An ‘‘environmental assessment,’’ in 

the foodborne illness outbreak or food 

contamination setting, means an 

investigation that is triggered by an 

outbreak of foodborne illness or food 

contamination incident with the 

purpose of determining how the 

environment may have contributed to 

the introduction or transmission of 

pathogens or other hazards that caused 

illness or contamination. In addition to 

our more traditional investigational 

team approach, during this process we 

work collaboratively with a number of 

experts from CDC, State and local 

agencies, and industry. 

In 2010, we conducted an 

environmental assessment in response 

to a foodborne illness outbreak 

involving 33 cases of STEC O145 

infection in 5 States. While we have not 

made a definitive determination 

regarding how or at what point in the 

supply chain E. coli O145 

contamination occurred, this assessment 

was important in a number of respects. 

As mentioned above, we worked 

collaboratively with a number of experts 

from CDC, State and local agencies, and 

industry. Working with this team, we 

assessed potential sources of E. coli 

O145 not just in the field of interest, but 

in the larger growing area surrounding 

the field of interest, along with the 

potential for E. coli O145 to be 

transported from a source in the 

surrounding area to the field where 

implicated lettuce was grown. This 

highly collaborative, systems-based 

approach allowed for the discovery of 

important environmental risk factors 

that would not typically be explored by 

conventional investigation methods 

(Ref. 21). On December 29, 2010, we 

posted a report, entitled ‘‘Environmental 

Assessment: Non-O157 Shiga ToxinProducing E. coli (STEC): Findings and 

Potential Preventive Control Strategies’’ 

(Ref. 21), outlining the environmental 

assessment approach used in this 

investigation, our observations and 

tentative conclusions. 

In 2011, we conducted an 

environmental assessment in response 

to a foodborne illness outbreak 

involving a total of 139 persons infected 

with any of four outbreak-associated 

strains of L. monocytogenes, including 

29 deaths, in 28 States (as of November 

1, 2011). On October 19, 2011, we 

posted a report, entitled ‘‘Environmental 

Assessment: Factors Potentially 

Contributing to the Contamination of 

Fresh Whole Cantaloupe Implicated in a 

Multi-State Outbreak of Listeriosis,’’ 

providing an overview of the assessment 

process, potential contributing factors in 

this outbreak, and recommended 

measures firms should employ to 

prevent similar contamination (http:// 

www.fda.gov/Food/FoodSafety/ 

FoodborneIllness/ucm276247.htm). As 

discussed further in sections III.F and 

V.A.2.b.i of this document, this 

proposed rule would not apply to offfarm packing facilities such as the 

packing facility associated with this 

cantaloupe outbreak—such facilities 

would instead be subject to existing part 

110 and section 418 of the FD&C Act. 

However, we include the findings of 

this environmental assessment here 

because the contributing factors are 

relevant to both on-farm and off-farm 

produce packing practices. 

3. Produce Safety Initiative Assessments 

In August 2006 we launched the Leafy 

Greens Safety Initiative (LGSI), a multiyear initiative which involved 

assessments of practices and conditions 

at select leafy greens farms and facilities 

in California (Ref. 22). In the summer of 

2007, we began a multi-year Tomato 

Safety Initiative (TSI) to assess practices 

and conditions associated with growing 

and packing tomatoes on the Eastern 

Shore of Virginia, followed by 

assessments in three tomato growing 

areas in Florida (Ref. 23). 

The initiatives were conducted as part 

of a strategy to reduce foodborne illness 

by focusing food safety efforts on 

specific products, practices, and 

growing areas that have been identified 

in past outbreak investigations. The 

initiatives were a collaborative effort 

between FDA and the State health and 

agriculture departments in California, 

Virginia, and Florida, in cooperation 

with several universities and members 

of the produce industry. Both initiatives 

contained several important 

components, the most visible of which 

was a series of assignments to the field 

to assess conditions and practices at 

farms and packing houses that could 

lead to contamination and to observe 

actions taken by growers and packers in 

response to these conditions. Other 

important components of the initiatives 

included continuing communication 

and outreach with the industry at all 

points along the supply chain, 

facilitating and promoting research to 

enhance leafy green and tomato safety, 

and strengthening collaboration 

between Federal, State, and local public 

health officials in disease detection and 

response. 

Assessments of tomato packing 

facilities covered dump tank water 

quality parameters, employee hygiene, 

and facility cleaning and sanitation 

practices. Assessments of the farms 

addressed irrigation water sources (such 

as ponds and wells), source water and 

procedures for mixing crop chemicals, 

the potential impacts of weather events, 

such as drought and flooding, and 

animal proximity to growing fields. 

Assessments were scheduled to 

coincide with tomato production and 

harvest seasons on the Eastern Shore of 

Virginia and in three tomato producing 

regions in Florida. 

Where the teams observed conditions 

or practices at one or more locations 

that might be improved, they shared 

those observations directly with the 

individual firm and also shared 

observations in general terms at a postassessment meeting so that all interested 

parties could apply the findings to their 

operations. For example, we identified 

issues related to proximity of portable 

toilets to irrigating ponds and harvesting 

of drops at one or more locations. The 

teams recommended that portable 

toilets should be distanced from the 

irrigation pond and policies that forbid 

the harvesting of drops should be 

strictly enforced. We also shared 

preliminary observations through other 

venues, including a tomato research 

priorities meeting in College Park 

(hosted by Joint Institute for Food Safety 

and Applied Nutrition (JIFSAN) and the 

University of Florida’s Institute of Food 

and Agricultural Sciences) (JIFSAN 

2010 (update)), a Leafy Greens Research 

Needs workshop hosted by United Fresh 

in Herndon, VA (United Fresh 2008), 

and as technical assistance to public 

and private efforts to develop new or 

enhanced guidances. 

4. Research 

FDA researchers have focused on 

refining or developing methods to 

detect, isolate and subtype pathogens of 

concern in produce, to enhance our 

ability to analyze samples in support of 

our compliance activities. As resources 

permit, FDA scientists also directly 

investigate questions about factors 

contributing to produce contamination. 

We also supported extramural research 

and collaborations with other Federal 

agencies, academic institutions, and 

industry-supported entities to leverage 

research efforts, expertise, and resources 

(such as experimental stations for field 

research). This includes successful 

collaborations with USDA on research 

of mutual interest. To fill knowledge 

gaps, thus facilitating implementation of 

any new policies, we have initiated new 

agreements with USDA to conduct 

research in key areas such as 

agricultural water and soil amendments 

(Ref. 24). Specifically, FDA has 

provided approximately one million 

dollars to sponsor research at USDA 

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ARS and to develop a produce safety 

rule research network at the Western 

Center for Food Safety at University of 

California Davis. We intend these 

collaborative efforts to result in the 

collection of data that may help resolve 

questions about the necessary time 

between application of raw manure or 

contaminated water and safe harvest of 

produce in key agro-ecological growing 

conditions and for key crops. Our goal 

is for this research to result in suggested 

protocols that farms could follow in 

compliance with a final produce rule, 

and for this process to be duplicated for 

other crops and regions as further 

funding is secured. This FDA sponsored 

research was initiated to demonstrate 

the commitment of federal agencies to 

address the needs of farmers, to provide 

initial data to finalize study protocols 

for further research, and to attract 

matching funds from industry. 

In partnership with academic 

institutions across the country, FDA has 

also created four Centers of Excellence 

(CoE), each housed at a university and 

charged with specific food-safety tasks 

(Ref. 25). In 2008, a 5-year cooperative 

agreement was awarded to the 

University of California, Davis (UC 

Davis) to establish the most recent of 

these CoEs, the Western Center for Food 

Safety (WCFS). Through this agreement, 

FDA has been able to leverage the 

resources and expertise of UC Davis to 

study the impact of the unique 

geography and ecology of the growing 

regions of the Western United States. 

5. Engagement With Other Federal 

Agencies 

FDA regularly consults and 

coordinates with other Federal agencies 

in the area of produce safety. Examples 

of these efforts can be found throughout 

this document and include collecting 

samples, sharing data, providing 

training and technical assistance to 

industry, and research. Our partnerships 

with USDA and CDC have been 

particularly valuable to our efforts. 

6. Engagement with Industry and 

Academia 

We regularly engage with experts in 

the produce industry and in academia. 

These engagements serve to both 

educate the industry about our thinking, 

activities, and expectations, and to 

educate us about current industry 

practices and academic efforts to 

enhance the safety of produce. 

In addition to the collaborations 

mentioned above, we initiated multiple 

produce industry listening sessions 

across the country prior to the passage 

of FSMA. At these sessions, we 

provided local industry and academia 

an opportunity to ask questions and 

voice concerns about the potential for 

legislation impacting the produce 

industry. We visited a total of 13 States 

with significant produce production in 

2010. FDA and USDA technical experts, 

scientists and managers participated in 

these meetings, and we were able to tour 

large and smaller scale farms, and talk 

to people with practical experience in 

production and implementing food 

safety programs on farms. 

We also were involved with the 

Produce Safety Project (PSP), a research 

and advocacy organization based at 

Georgetown University and funded by 

the Pew Charitable Trust. The PSP 

provided four issue briefs (Ref. 26.Ref. 

27.Ref. 28.Ref. 29) each focused on 

specific aspects of produce production, 

the risks they may represent, prevention 

and mitigation strategies to address 

these risks, and further research needs 

in the area. Further, PSP held 6 regional 

stakeholder discussion sessions to elicit 

comment and reaction from the produce 

industry, and to offer an avenue to 

speak directly to the documents’ 

authors. A common message from the 

industry during these discussions was 

concern about food safety and a desire 

to know how to reduce risks. Small 

growers and packers in particular 

conveyed a need for information and 

technical support that would assist 

them in implementing food safety 

practices. 

E. Current Industry Practices 

In response to foodborne illnesses 

associated with produce in the mid 

1990s, the produce industry developed 

produce safety guidance, engaged in 

outreach regarding produce safety best 

practices, developed compliance 

auditing programs, and funded produce 

safety research. 

1. Industry Produce Safety Best 

Practices Guidance 

In 1997, the International Fresh-cut 

Produce Association and the Western 

Growers Association published 

Voluntary Food Safety Guidelines for 

Fresh Produce, which provided 

generalized voluntary industry 

guidelines to minimize the potential for 

contamination for fresh produce in 

growing, packing, shipping and 

processing operations. After FDA issued 

our GAPs Guide, industry developed 

commodity specific guidances for 

various produce industry segments 

including: Commodity Specific Food 

Safety Guidelines for the Melon Supply 

Chain (2005), Commodity Specific Food 

Safety Guidelines for the Lettuce and 

Leafy Greens Supply Chain (2006), 

Commodity Specific Food Safety 

Guidelines for the Fresh Tomato Supply 

Chain (2006 1st Edition, 2008 2nd 

edition) and Commodity Specific Food 

Safety Guidelines for the Production, 

Harvest, Post-Harvest, and ValuedAdded Unit Operations of Green Onions 

(2010). In addition, other industry 

segments including, but not limited to 

mushrooms, strawberries, watermelons, 

citrus, avocados, almonds, and dry bulb 

onions developed commodity specific 

guidances. The fresh-cut produce 

industry, via the International Fresh 

Produce Association, published in 1992 

Food Safety Guidelines for the Fresh-cut 

Produce Industry and updated this 

publication periodically, with the 4th 

edition being published most recently in 

2001. 

2. Produce Industry Food Safety 

Compliance Auditing 

Shortly after the FDA GAPs Guide 

was finalized, a number of retail 

produce buyers informed suppliers that 

as a condition of sale, their produce 

suppliers must follow, and be third 

party audited for conformance with, the 

FDA GAPs guide (Ref. 30). In 1999 

USDA AMS began developing a GAPs 

and Good Handling Practices (GAP & 

GHP) Audit Verification Program, in 

response to requests from growers and 

the Association of Fruit and Vegetable 

Inspection and Standardization 

Agencies. The program, based on the 

GAPs Guide, was piloted in 2000 and 

fully available later that same year. In 

September 2001 the United Fresh Fruit 

and Vegetable Association published 

guidance entitled Food Safety Auditing 

Guidelines: Core Elements of Good 

Agricultural Practices for Fresh Fruits 

and Vegetables to provide the basis for 

GAPs audits in the produce industry. In 

2011 the United Fresh Produce 

Association published a Harmonized 

GAPs Standard for use by producers and 

third party auditors in the fresh produce 

industry. 

In 2007 leafy greens growers in 

California, with the assistance of the 

USDA AMS and CDFA, developed and 

implemented the California Leafy 

Greens Marketing Agreement (CA 

LGMA) (Ref. 31). The objective of the 

CA LGMA is to protect public health via 

compliance with the food safety 

practices accepted by the LGMA board, 

verified through mandatory government 

audits of members and signatories to the 

agreement by CDFA auditors trained 

and licensed by USDA AMS (Ref. 31). 

In 2007 leafy greens growers in Arizona 

also adopted a similar marketing 

agreement and audit structure for their 

growers (Ref. 32). At the request of 

industry, the USDA AMS in 2009 held 

seven hearings throughout the United 

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States to solicit input from the leafy 

greens industries across the U.S. 

regarding their desire to develop a 

proposed national marketing agreement 

for leafy greens (74 FR 45565). A 

decision regarding the proposed USDA 

AMS national marketing agreement for 

leafy greens is currently pending. 

In 2007, the Florida Legislature 

passed a law that provided the 

Department of Agriculture and 

Consumer Services with the authority to 

address safety concerns related to fresh 

tomatoes. Implementing regulations 

which became effective on July 1, 2008 

(Florida Tomato Inspection Regulation 

5G–6, 2007) adopted and incorporated 

by reference almost all of the 

recommendations in the Commodity 

Specific Food Safety Guidelines for the 

Fresh Tomato Supply Chain, 2nd 

Edition (July 2008). 

GAPs implementation and GAPs 

audits have now become common 

components of purchase specifications 

for produce in some market segments, 

and have been a significant force in 

increasing awareness of GAPs and 

promoting their implementation (Ref. 

33). However, growers and packers who 

sell product through direct marketing 

channels, or to buyers who do not 

include GAPs as a condition of sale, 

may be less familiar with GAPs. 

3. Produce Industry Produce Safety 

Education Outreach 

In addition to participation in the 

PSA housed at Cornell University 

(discussed above in section II.D. of this 

document), the produce industry 

promoted adoption and implementation 

of the recommendations in the FDA 

GAPs Guide through education and 

outreach efforts in cooperation with the 

land grant universities. The National 

GAPs Program at Cornell University, 

with collaborators at other land grant 

universities, developed a series of 

publications to train domestic growers 

and packers on the key principles of 

produce safety, including: Food Safety 

Begins on the Farm: A Grower’s Guide 

(2000); Food Safety Begins on the Farm: 

A Grower Self Assessment of Food 

Safety Risks (2003); and, Fruits, 

Vegetables, and Food Safety: Health and 

Hygiene on the Farm (2004). These 

publications and others developed by 

land grant universities throughout the 

United States have been used to train 

the produce industry on produce safety 

best practices. 

F. 2010 Federal Register Notice and 

Preliminary Stakeholder Comments 

On February 23, 2010, we published 

in the Federal Register (75 FR 8086; 

2010 FR notice) a notice opening a 

docket to obtain information about 

current practices and conditions for the 

production and packing of fresh 

produce. On May 20, 2010, we extended 

the original 90-day comment period for 

the docket until July 23, 2010 (75 FR 

28263). We established this docket to 

provide an opportunity for interested 

parties to provide information and share 

views that would inform the 

development of (1) safety standards for 

fresh produce at the farm and packing 

house and (2) strategies and cooperative 

efforts to ensure compliance. 

In particular, we welcomed input on 

these general categories: (1) Role of the 

good agricultural practice 

recommendations in the GAPs Guide; 

(2) Standards for domestic and foreign 

growers and packers; (3) Identification 

and prioritization of risk factors; (4) 

Environmental assessment of hazards 

and possible pathways of 

contamination; (5) The impact of scale/ 

size of growing operations on the nature 

and degree of possible food safety 

hazards; (6) Methods to tailor preventive 

controls to particular hazards and 

conditions affecting an operation; (7) 

Possible approaches to tailoring 

preventive controls to the scale of an 

operation so that the controls achieve an 

appropriate level of food safety 

protection and are feasible for a wide 

range of large and small operations; (8) 

Coordination of produce food safety 

practices and sustainable and/or organic 

production methods; (9) Coordination of 

produce food safety practices and 

environmental and/or conservation 

goals or practices; (10) Coordination of 

produce food safety practices and 

Federal, state, local and tribal 

government statutes and regulations; 

(11) Microbial testing; (12) Postharvest 

operations and the role of the CGMPs in 

21 CFR part 110; (13) Records and other 

documentation that would be useful to 

industry and regulators in ensuring the 

safety of fresh produce; and (14) 

Strategies to enhance compliance. 

We further advised that information 

previously submitted to the dockets 

requesting comments on the draft 

commodity-specific guidances (CSGs), 

or to the docket requesting comments 

and scientific data and information to 

update the GAPs Guide, would be 

considered in this rulemaking and need 

not be resubmitted. Comments 

submitted to these dockets, i.e., dockets 

on the GAPs Guide update and draft 

CSGs, as well as comments at the 

Sprouts Public Meeting and Produce 

Safety Hearings, are discussed in 

sections II.B. and II.D. of this document. 

In response to the 2010 FR notice, we 

received about 880 comments from 

consumers, farmers and producers, 

industry groups and trade associations, 

consumer groups, environmental 

groups, academia, retail establishments, 

packers and handlers, food markets and 

coops, laboratories and public health 

facilities, and federal, state, local and 

foreign governments. The USDA 

Agricultural Marketing Service (AMS) 

submitted a record of their public 

hearings related to their proposed 

voluntary national marketing agreement 

for leafy green vegetables (NLGMA) (74 

FR 45565, September 3, 2009 and 74 FR 

48423, September 23, 2009), and 

requested that we consider the contents 

of that record (which included 

testimony, exhibits, and written 

arguments or briefs based on evidence 

received at the public hearing) in our 

deliberations to develop safety 

standards for fresh produce. A summary 

of general comments received is 

presented in this section while specific 

comments relevant to the issues 

addressed in this proposed rule are 

discussed in sections V.C through V.R of 

this document. 

1. Comments on Impact, Flexibility and 

Transparency 

Overall, a majority of stakeholders, 

including farmers, producers, 

consumers and industry, expressed 

concern about the scope and impact of 

regulation on the livelihoods of those 

who produce food and on their ability 

to produce food in an economicallyfeasible manner. Most comments 

supported a food safety system, 

grounded in science, for the production 

of produce in a fair and equitable 

manner for both domestic and imports. 

Comments noted that regulations 

developed should be science-based and 

provide for producers to manage risks in 

a manner appropriate to their 

operations. Several comments 

maintained that risk assessments, 

hazard assessments, operational 

assessments and development of food 

safety plans are vital tools for farmers to 

be able to demonstrate that the food 

safety practices they employ are 

effective. Conversely, others questioned 

the need for some industry segments, 

such as small farms or growers of ‘‘low 

risk’’ commodities to establish food 

safety plans. A majority of comments 

also stated that research is needed on 

various issues relevant to produce 

safety, including water quality, soil 

amendments, animals (both wildlife and 

domesticated), and worker health and 

hygiene. Comments urged the agency to 

tailor regulations to reflect variables 

such as farm size, markets served, 

growing conditions, and risk. In 

addition, comments highlighted the 

importance of transparency in the 

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development and implementation of 

food safety standards, and expressed 

that transparency provides regulators, 

buyers, and the public with the 

confidence they need to ensure that all 

reasonable and required practices have 

been put in place and that any specific 

producer or packer of produce is in 

compliance with required food safety 

practices. FSMA directs us to establish 

science-based minimum standards for 

produce safety. These standards are to 

include procedures, processes, and 

practices that we determine to be 

reasonably necessary to prevent the 

introduction of known or reasonably 

foreseeable biological, chemical, and 

physical hazards into covered produce 

and to provide reasonable assurances 

that produce is not adulterated under 

section 402 of the FD&C Act. As 

discussed in section IV below, FDA 

intends to adopt a regulatory approach 

that considers the risk posed by both the 

commodity and relevant agronomic 

practices, and provides the most 

appropriate balance between public 

health protection and flexibility. We 

recognize the need to incorporate 

appropriate flexibility within 

regulations to reflect the diversity of 

commodities and associated processes, 

practices, and conditions covered 

within the scope of this rule. For 

example, exemptions based on 

monetary value of food sold by the farm 

and direct farm marketing, commercial 

processing of commodities, and other 

criteria are reflected in proposed 

subpart A. Under certain specified 

conditions, qualified exemptions and 

associated modified requirements in a 

calendar year are also provided under 

proposed subpart A. In addition, 

proposed § 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 agroecological conditions and therefore 

alternatives to certain requirements 

would be permitted when adequate and 

documented scientific data or 

information support such alternatives. 

Similarly, proposed subpart P sets 

procedures for a State or foreign country 

to request a variance from one or more 

requirements of this part when certain 

conditions are met, as required by 

Section 419(c)(2) of the FD&C Act. For 

example, a State or foreign country may 

consider that the historical performance 

of an industry within their jurisdiction 

(e.g., as indicated by the 

epidemiological record) and the 

combination of measures taken by that 

industry merits requesting a variance 

from some or all provisions of this 

proposed rule. In requesting a variance, 

among other things, the State or foreign 

country would submit information that, 

while the procedures, processes and 

practices to be followed under the 

variance would be different from those 

prescribed in this proposed rule, the 

requested variance is reasonably likely 

to ensure that the produce is not 

adulterated under section 402 of the 

FD&C Act and provide the same level of 

public health protection as the 

requirements of the final regulations 

(see proposed 112.173). FDA would 

encourage consideration of these kinds 

of submissions. 

Furthermore, in addition to soliciting 

comments on the proposed regulation 

through this notice, we will be holding 

public meetings in diverse geographic 

areas of the United States to provide 

persons in different regions an 

opportunity to comment, as required 

under Section 419(a)(2) of the FD&C 

Act. 

2. Comments on Environmental 

Considerations 

Several comments pointed out that 

there are a number of state and federal 

laws and programs that relate to 

environmental stewardship, and noted 

that environmental conservation and 

food safety are not necessarily crosscompeting goals. Comments favored a 

uniform regulatory approach among 

Federal, State, local and tribal 

governments’ statutes and regulations, 

and recommended that we consider the 

work of other Federal agencies, 

including the Environmental Protection 

Agency, the Department of Agriculture, 

and the Department of the Interior in 

developing proposed requirements for 

produce to ensure such requirements do 

not unnecessarily inhibit comanagement of food safety and 

environmental concerns. In this regard, 

a few comments stated that while comanagement of food safety and 

sustainability may be considered, 

ultimately, food safety has to be top 

priority and it is unacceptable to sell 

unsafe food to customers. 

Section 419(a)(3)(D) of the FD&C Act 

directs that this proposed rule take into 

consideration, consistent with ensuring 

enforceable public health protection, 

conservation and environmental 

practice standards and policies 

established by Federal natural resource 

conservation, wildlife conservation, and 

environmental agencies. As discussed 

further in Sections III.A.8 and V.I, we 

consulted with several Federal agencies 

in order to take into consideration 

conservation and environmental 

practice standards and policies 

established by those agencies. FDA also 

plans to work closely with Federal, 

State, and local agencies in 

implementing the final rule. 

3. Comments on Guidance and 

Education 

A majority of comments also 

expressed the need for guidance to 

assist stakeholders in implementing the 

requirements established in final 

regulations. Moreover, several 

comments stressed the importance of 

educational programs and incentives in 

any effective food safety system. 

Section 419(e) of the FD&C Act 

requires FDA to publish updated good 

agricultural practices and guidance for 

the safe production and harvesting of 

specific types of fresh produce, in 

consultation with the Secretary of 

Agriculture, representatives of State 

departments of agriculture, farmer 

representatives, and various types of 

entities engaged in the production and 

harvesting or importing of fruits and 

vegetables that are raw agricultural 

commodities, including small 

businesses. In addition, section 419(e) of 

the FD&C Act requires FDA to conduct 

education and outreach regarding this 

guidance through public meetings in 

diverse geographical regions. FDA 

intends to provide ample opportunity 

for public consultation and input and 

will strive to develop stronger 

partnerships with the private sector to 

ensure optimal use of resources. 

4. Comments Related to Foreign 

Producers 

A number of foreign governments 

expressed concerns with the foreign 

producers’ ability to comply with and 

FDA’s enforcement of the regulation, 

stressing the need for transparency. 

Some comments requested we consider 

convergence with existing private 

schemes, such as the Global Food Safety 

Initiative and Global G.A.P to avoid 

duplication of efforts while others urged 

us to consider recognition of foreign 

governments’ produce safety initiatives. 

In implementing a final rule based on 

this proposed rule, we intend to provide 

equal treatment in the application, 

compliance, and enforcement of the 

proposed standards for foreign and 

domestic facilities. Recognizing that 

foreign farms in some countries may 

have difficulty in understanding the 

rule’s applicability to them, we will 

partner with stakeholders to identify 

areas for outreach and technical 

cooperation to achieve greater 

understanding of the proposed 

provisions. 

Furthermore, consistent with section 

419(c)(2) of the FD&C Act, in proposed 

subpart P, we establish a procedure 

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3516 Federal Register / Vol. 78, No. 11 / Wednesday, January 16, 2013 / Proposed Rules 

whereby a State or foreign country 

could request a variance from one or 

more requirements proposed in the rule, 

where the State or foreign country 

determines that (1) the variance is 

necessary in light of local growing 

conditions; and (2) the procedures, 

processes, and practices to be followed 

under the variance are reasonably likely 

to ensure that the produce is not 

adulterated under section 402 of the 

FD&C Act, and to provide the same level 

of public health protection as the 

requirements of this rule (see section 

V.P. of this document). 

G. White House Food Safety Working 

Group 

In 2009, President Obama established 

a White House Food Safety Working 

Group to identify measures needed to 

upgrade our food safety laws for the 21st 

Century, coordinate Federal efforts, and 

develop short- and long-term agendas to 

make food safer. Specific objectives of 

this workgroup included: Fostering 

coordination of food safety efforts 

throughout the government and 

ensuring laws are being adequately 

enforced to keep the American people 

safe from foodborne illness. The 

workgroup was co-chaired by the 

Secretaries of the HHS and USDA. 

Participating agencies included FDA, 

USDA’s Food Safety and Inspection 

Service (FSIS), CDC, the Department of 

Homeland Security, the Department of 

Commerce, the Department of State, 

EPA, and several offices of the White 

House. 

On July 7, 2009, the workgroup 

released its report ‘‘Implementing a 

National Public Health Approach to 

Food Safety: Report to the President.’’ 

This report included recommendations 

for a new public health-focused 

approach to the safety of all food based 

on three core principles: (1) Prioritizing 

prevention, (2) strengthening 

surveillance and enforcement, and (3) 

improving response and recovery. 

Workgroup recommendations and 

White House directives specific to 

produce included (1) issuing 

commodity-specific guidances to reduce 

the likelihood of microbial 

contamination in the production and 

distribution of tomatoes, melons, and 

leafy greens; and (2) taking steps 

(including seeking public comment) to 

establish required practices through 

regulation. The numerous steps we have 

taken in response to these directives are 

described throughout this section. 

H. Other Related Issues 

1. Tracking and Tracing of Produce 

Our regulations in 21 CFR part 1, 

subpart J require that persons who 

manufacture, process, pack, transport, 

distribute, receive, hold, or import food 

in the United States establish and 

maintain records identifying the 

immediate previous sources and 

immediate subsequent recipients of 

food. During an outbreak of foodborne 

illness, these records can help 

determine the source of the food 

implicated in the outbreak. Farms are 

excluded from the requirements of part 

1, subpart J. We recently held public 

meetings to stimulate and focus a 

discussion about mechanisms to 

enhance product tracing systems for 

food in general (74 FR 56843; November 

3, 2009) and for produce in particular 

(73 FR 55115; September 24, 2008). 

Section 204 of FSMA now directs us to 

take a variety of different actions that 

will enhance our ability to track and 

trace foods, including to establish pilot 

projects to explore and evaluate 

methods to rapidly and effectively 

identify recipients of food to prevent or 

control a foodborne illness outbreak. 

Further efforts to enhance the tracking 

and tracing of food are outside of the 

scope of this proposed rule. 

2. Transportation of Food 

On April 30, 2010 (75 FR 22713), we 

published in the Federal Register an 

Advance Notice of Proposed 

Rulemaking (ANPRM) as a first step in 

implementing the Sanitary Food 

Transportation Act of 2005 (SFTA). 

SFTA requires the Secretary of HHS to 

issue regulations setting forth sanitary 

transportation practices to be followed 

by shippers, carriers by motor vehicle or 

rail vehicle, receivers, and others 

engaged in food transport. Section 111 

of FSMA directs us to promulgate 

regulations to implement SFTA. We 

intend to focus our efforts directed to 

sanitary transportation practices as a 

separate rulemaking, already underway 

under the ANPRM. However, such 

efforts are outside of the scope of this 

proposed rule. 

III. Legal Authority 

FDA is proposing this regulation 

under the FD&C Act as amended by 

FSMA, and the Public Health Service 

Act (PHS Act). 

A. Section 105 of FSMA and Section 419 

of the FD&C Act 

On January 4, 2011, the FDA Food 

Safety Modernization Act (FSMA) (Pub. 

L. 111–353) was signed into law. 

Section 105 of FSMA, Standards for 

Produce Safety, among other things, 

amends the FD&C Act to create a new 

section 419 with the same name. 

Section 419(a)(1)(A) of the FD&C Act 

directs the Secretary of HHS, ‘‘in 

coordination with the Secretary of 

Agriculture and representatives of State 

departments of agriculture (including 

with regard to the national organic 

program established under the Organic 

Foods Production Act of 1990), and in 

consultation with the Secretary of 

Homeland Security,’’ to ‘‘publish a 

notice of proposed rulemaking to 

establish science-based minimum 

standards for the safe production and 

harvesting of those types of fruits and 

vegetables, including specific mixes or 

categories of fruits and vegetables, that 

are raw agricultural commodities for 

which the Secretary has determined that 

such standards minimize the risk of 

serious adverse health consequences or 

death.’’ In addition to this broad 

direction in section 419(a)(1)(A), section 

419(a)(3) establishes more specific 

requirements for the content of the 

proposed rule, including that the 

proposed rule: 

• ‘‘[P]rovide sufficient flexibility to be 

applicable to various types of entities 

engaged in the production and 

harvesting of fruits and vegetables that 

are raw agricultural commodities, 

including small businesses and entities 

that sell directly to consumers, and be 

appropriate to the scale and diversity of 

the production and harvesting of such 

commodities’’ (section 419(a)(3)(A)); 

• ‘‘[I]nclude, with respect to growing, 

harvesting, sorting, packing, and storage 

operations, science-based minimum 

standards related to soil amendments, 

hygiene, packaging, temperature 

controls, animals in the growing area, 

and water’’ (section 419(a)(3)(B)); 

• ‘‘[C]onsider hazards that occur 

naturally, may be unintentionally 

introduced, or may be intentionally 

introduced, including by acts of 

terrorism’’ (section 419(a)(3)(C)); 

• ‘‘[T]ake into consideration, 

consistent with ensuring enforceable 

public health protection, conservation 

and environmental practice standards 

and policies established by Federal 

natural resource conservation, wildlife 

conservation, and environmental 

agencies’’ (section 419(a)(3)(D)); 

• ‘‘[I]n the case of production that is 

certified organic, not include any 

requirements that conflict with or 

duplicate the requirements of the 

national organic program established 

under the Organic Foods Production Act 

of 1990, while providing the same level 

of public health protection as the 

requirements under guidance 

documents, including guidance 

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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 sciencebased standards for those types of fruits 

and vegetables, including specific mixes 

or categories of fruits and vegetables, 

that are raw agricultural commodities, 

based on known safety risks, which may 

include a history of foodborne illness 

outbreaks’’ (section 419(b)(1)); 

• ‘‘[P]rovide for coordination of 

education and enforcement activities by 

State and local officials, as designated 

by the Governors of the respective States 

or the appropriate elected State official 

as recognized by State statute’’ (section 

419(b)(2)(A)); and 

• ‘‘[I]nclude a description of the 

variance process under [section 419(c)] 

and the types of permissible variances 

the Secretary may grant’’ (section 

419(b)(2)(B)). 

In section 419(c), the FD&C Act 

establishes criteria for the final 

regulation, including that the final 

regulation: 

• ‘‘[S]et forth those procedures, 

processes, and practices that the 

Secretary determines to minimize the 

risk of serious adverse health 

consequences or death, including 

procedures, processes, and practices 

that the Secretary determines to be 

reasonably necessary to prevent the 

introduction of known or reasonably 

foreseeable biological, chemical, and 

physical hazards, including hazards that 

occur naturally, may be unintentionally 

introduced, or may be intentionally 

introduced, including by acts of 

terrorism, into fruits and vegetables, 

including specific mixes or categories of 

fruits and vegetables, that are raw 

agricultural commodities and to provide 

reasonable assurances that the produce 

is not adulterated under section 402’’ 

(section 419(c)(1)(A)); 

• ‘‘[P]rovide sufficient flexibility to be 

practicable for all sizes and types of 

businesses, including small businesses 

such as a small food processing facility 

co-located on a farm’’ (section 

419(c)(1)(B)); 

• ‘‘[C]omply with chapter 35 of title 

44, United States Code (commonly 

known as the ‘Paperwork Reduction 

Act’), with special attention to 

minimizing the burden (as defined in 

section 3502(2) of such Act) on the 

business, and collection of information 

(as defined in section 3502(3) of such 

Act), associated with such regulations’’ 

(section 419(c)(1)(C)); 

• ‘‘[A]cknowledge differences in risk 

and minimize, as appropriate, the 

number of separate standards that apply 

to separate foods’’ (section 419(c)(1)(D)); 

• ‘‘[N]ot require a business to hire a 

consultant or other third party to 

identify, implement, certify, compliance 

with these procedures, processes, and 

practices, except in the case of 

negotiated enforcement resolutions that 

may require such a consultant or third 

party’’ (section 419(c)(1)(E); 

• ‘‘[P]ermit States and foreign 

countries from which food is imported 

into the United States to request from 

the Secretary variances from the 

requirements of the regulations, subject 

to [section 419(c)(2) of the FD&C Act], 

where the State or foreign country 

determines that the variance is 

necessary in light of local growing 

conditions and that the procedures, 

processes, and practices to be followed 

under the variance are reasonably likely 

to ensure that the produce is not 

adulterated under section 402 [of the 

FD&C Act] and to provide the same 

level of public health protection as the 

requirements of the regulations adopted 

under [section 419(b) of the FD&C Act]’’ 

(section 419(c)(1)(F)); and 

• Establish requirements relating to 

variances, including that: 

Æ ‘‘A State or foreign country from 

which food is imported into the United 

States may in writing request a variance 

from the Secretary. Such request shall 

describe the variance requested and 

present information demonstrating that 

the variance does not increase the 

likelihood that the food for which the 

variance is requested will be adulterated 

under section 402, and that the variance 

provides the same level of public health 

protection as the requirements of the 

regulations adopted under [section 

419(b) of the FD&C Act]. The Secretary 

shall review such requests in a 

reasonable timeframe’’ (section 

419(c)(2)(A)). 

Æ ‘‘The Secretary may approve a 

variance in whole or in part, as 

appropriate, and may specify the scope 

of applicability of a variance to other 

similarly situated persons’’ (section 

419(c)(2)(B)). 

Æ ‘‘The Secretary may deny a 

variance request if the Secretary 

determines that such variance is not 

reasonably likely to ensure that the food 

is not adulterated under section 402 and 

is not reasonably likely to provide the 

same level of public health protection as 

the requirements of the regulation 

adopted under [section 419(b) of the 

FD&C Act]. The Secretary shall notify 

the person requesting such variance of 

the reasons for the denial’’ (section 

419(c)(2)(C)). 

Æ ‘‘The Secretary, after notice and an 

opportunity for a hearing, may modify 

or revoke a variance if the Secretary 

determines that such variance is not 

reasonably likely to ensure that the food 

is not adulterated under section 402 and 

is not reasonably likely to provide the 

same level of public health protection as 

the requirements of the regulations 

adopted under [section 419(b) of the 

FD&C Act]’’ (section 419(c)(2)(D)). 

In addition, section 105(c) of FSMA 

creates a new section 301(vv) in the 

FD&C Act (21 U.S.C. 331(vv)) to prohibit 

‘‘[t]he failure to comply with the 

requirements under section 419 [of the 

FD&C Act].’’ 

1. Coordination and Consultation 

Requirements 

Consistent with section 419(a)(1)(A) 

of the FD&C Act, FDA has coordinated 

with the Secretary of Agriculture and 

representatives of State departments of 

agriculture (Ref. 34. Ref. 35) and 

consulted with the Secretary of 

Homeland Security regarding this 

proposed rule. 

2. Definitions of Small and Very Small 

Businesses 

Section 419(a)(3)(F) of the FD&C Act 

requires that the regulations define the 

terms ‘‘small business’’ and ‘‘very small 

business.’’ These terms are significant 

because section 419 of FSMA contains 

provisions specific to such entities. 

• ‘‘With respect to small and very small 

businesses* * * that produce and harvest 

those types of fruits and vegetables that are 

raw agricultural commodities that the 

Secretary has determined are low risk and do 

not present a risk of serious adverse health 

consequences or death, the Secretary may 

determine not to include production and 

harvesting of such fruits and vegetables in 

such rulemaking, or may modify the 

applicable requirements of regulations 

promulgated pursuant to [section 419]’’ 

(section 419(a)(1)(B) of the FD&C Act). 

• ‘‘[T]he regulations promulgated under 

[section 419 of the FD&C Act] shall apply to 

a small business* * * after the date that is 

1 year after the effective date of the final 

regulation* * * [and] to a very small 

business* * * after the date that is 2 years 

after the effective date of the final regulation’’ 

(section 419(b)(3) of the FD&C Act). 

In section V.A. of this document, we 

discuss our proposed definitions of 

small and very small business. In 

section IV.K. of this document, we 

discuss our proposal to establish 

compliance dates for small and very 

small businesses that are three and four 

years, respectively, after the effective 

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date of the final regulation, with 

additional, more extended compliance 

dates for certain proposed provisions 

related to water. FDA has tentatively 

decided not to exempt or modify the 

requirements of the proposed rule with 

respect to small and very small 

businesses that produce and harvest 

certain types of produce based on a 

determination that such types of 

produce are low risk and do not present 

a risk of serious adverse health 

consequences or death using the 

discretionary authority provided by 

section 419(a)(1)(B). It is not necessary 

to use this discretionary authority in 

part because, as discussed in section 

V.A. of this document, FDA proposes in 

§ 112.2 to exclude certain types of low 

risk produce from the coverage of this 

rule without regard to the business size 

of the farm producing and harvesting 

such produce. As discussed in section 

IV.C.2. of this document, these 

exclusions are based on our tentative 

conclusion that science-based minimum 

standards to minimize the risk of 

serious adverse health consequences or 

death from biological hazards in these 

commodities are not warranted. Another 

reason it is not necessary to use the 

discretionary authority in section 

419(a)(1)(B) is because, as discussed in 

section V.A. of this document, FDA 

proposes in § 112.4 to apply this 

regulation only to businesses with an 

average annual monetary value of food 

sold during the previous three-year 

period of more than $25,000 on a rolling 

basis, based on a tentative conclusion 

that businesses with $25,000 or less in 

sales do not contribute significantly to 

the produce market (1.5% of covered 

produce acres) and, therefore, to the 

volume of production that could 

become contaminated. Accordingly, we 

tentatively conclude that imposing the 

proposed requirements on these 

businesses is not warranted because it 

would have little measurable public 

health impact. We note that such farms 

would continue to be subject to the 

applicable requirements of the FD&C 

Act. 

3. Exemptions and Exceptions 

Section 419(f)(1) of the FD&C Act 

establishes an exemption from the 

requirements under section 419 based 

on average annual monetary value of the 

food sold directly to ‘‘qualified endusers’’ (as defined in section 419(f)(4)) 

as compared to all other buyers and 

average annual monetary value of all 

food sold. Section 419(f)(2) establishes 

requirements for consumer notifications 

with respect to food from exempt farms, 

and section 419(f)(3) provides that the 

Secretary may withdraw the exemption 

in specified circumstances. In sections 

V.A and V.R of this document, we 

discuss proposed §§ 112.5 and 112.6, 

and subpart R, respectively, which 

would implement these provisions of 

the FD&C Act. 

Section 419(g) of the FD&C Act states 

‘‘[t]his section shall not apply to 

produce that is produced by an 

individual for personal consumption.’’ 

In section V.A. of this document, we 

discuss proposed § 112.2(a)(2), which 

would implement this provision. 

Section 419(h) of the FD&C Act states 

‘‘[t]his section shall not apply to 

activities of a facility that are subject to 

section 418.’’ In sections III.F and 

V.A.2.b.i of this document we discuss 

proposed § 112.4(a), which would 

implement this provision. 

4. Intentional Adulteration 

FDA proposes to implement section 

105 of FSMA in two regulations, rather 

than a single regulation that covers all 

hazards relevant to produce. This 

rulemaking is not intended to address 

hazards ‘‘that may be intentionally 

introduced, including by acts of 

terrorism.’’ (§ 419(a)(3)(C) and (c)(1)(A) 

of the FD&C Act). FDA plans to 

implement section 105 of FSMA 

regarding such hazards in a separate 

rulemaking in the future, and intends to 

consult with the Secretary of Homeland 

Security in that rulemaking, as required 

by § 419(a)(1)(A) of the FD&C Act. FDA 

tentatively concludes that intentional 

hazards likely will require different 

kinds of controls and would be best 

addressed in a separate rulemaking. 

5. Science-Based Minimum Standards 

Related to Specific Topics 

Consistent with the provisions in 

Section 419(a)(3)(B) of the FD&C Act 

that requires us to establish ‘‘sciencebased minimum standards related to 

soil amendments, hygiene, packaging, 

temperature controls, animals in the 

growing area, and water,’’ this proposed 

rule addresses specific topics relevant to 

production and harvesting of produce 

on farms. We address standards related 

to soil amendments in subpart F; 

standards for hygiene in subpart D, 

standards for animals in the growing 

area in subpart I; and standards for 

water in subpart E. We address 

packaging as part of our proposed 

standards for harvest, packing, and 

holding activities in subpart K; and 

temperature controls as part of our 

proposed standards for agricultural 

water in subpart E. 

6. Providing Sufficient Flexibility To Be 

Practicable 

As required by section 419(a)(3)(A) 

and (c)(1)(B), this proposed rule would 

provide sufficient flexibility to be 

practicable for all sizes and types of 

entities engaged in the production and 

harvesting of fruits and vegetables that 

are raw agricultural commodities, 

including small businesses and entities 

that sell directly to consumers, and is 

appropriate to the scale and diversity of 

the production and harvesting of such 

commodities. 

As discussed in section IV of this 

document, we have chosen a regulatory 

approach that provides significant 

flexibility. We propose a variety of 

different types of measures (including 

GMP-type measures, numerical 

standards, requirements to monitor and 

take action under certain circumstances, 

and written plans) to tailor the 

requirements of the proposed rule 

appropriately and to be practical for the 

diversity of farms and commodities that 

would be covered by the proposed rule. 

Wherever possible, we have also 

attempted to fashion this regulation to 

be as flexible as possible to 

accommodate future changes in science 

and technology and the particularities of 

local growing conditions and 

commodities. As discussed in section 

V.B of this document, in proposed 

§ 112.12, we list the specific 

requirements established in this rule for 

which we would allow alternatives to be 

established and used in appropriate 

circumstances. This provision would 

provide significant flexibility by 

allowing individual farms to develop 

alternative standards suitable to their 

operations with appropriate scientific 

support. In addition, consistent with 

sections 419(c)(1)(F) and (c)(2) of the 

FD&C Act, in proposed subpart P, we 

provide for a mechanism by which a 

State or a foreign country from which 

food is imported into the United States 

may request a variance from one or 

more requirements proposed in this 

part, where the State or foreign country 

determines that: (a) The variance is 

necessary in light of local growing 

conditions; and (b) the procedures, 

processes, and practices to be followed 

under the variance are reasonably likely 

to ensure that the produce is not 

adulterated under Section 402 of the Act 

and to provide the same level of public 

health protection as the requirements of 

this part. Proposed subpart P would 

provide additional flexibility for 

alternative practices to be used where 

appropriate to specific local growing 

conditions and commodities. 

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7. Use of Third Parties 

In accordance with section 

419(c)(1)(E) of the FD&C Act, we are not 

proposing to require a farm to hire a 

consultant or third party to identify, 

implement, certify, or comply with 

these produce safety standards. These 

standards are intended to be capable of 

implementation by those who engage in 

routine activities on the farm. As 

discussed in section II.D.1 and V.Q., 

FDA has, together with USDA AMS, 

established a jointly funded Produce 

Safety Alliance (PSA), a public-private 

partnership that will develop and 

disseminate science- and risk-based 

training and education programs to 

provide produce farms with 

fundamental food safety knowledge. 

Education and outreach through 

mechanisms like PSA and other sources 

of information that are familiar to the 

produce farming community (such as 

Cooperative Extension, land grant 

universities and trade associations) is 

the foundation of our intended 

compliance strategy. Through these 

mechanisms, FDA aims to assist farmers 

in gaining the food safety knowledge 

they will need to comply with the 

provisions of a final produce safety rule. 

8. Consideration of Environmental 

Standards 

As required by section 419(a)(3)(D), in 

developing these produce safety 

standards and consistent with ensuring 

enforceable public health protection, we 

took into consideration conservation 

and environmental practice standards 

and policies established by Federal 

natural resource conservation, wildlife 

conservation, and environmental 

agencies. In developing this rule, we 

consulted with USDA’s National 

Organic Program and Natural Resources 

Conservation Service, U.S. Fish and 

Wildlife Service, and the EPA to take 

into consideration conservation and 

environmental practice standards and 

policies established by those agencies 

(Ref. 34). Our proposed requirements 

encourage the application of practices 

that can enhance food safety, including 

sustainable conservation practices. 

Additionally, as discussed in section 

V.E of this document, this proposed rule 

is designed to be compatible with 

existing conservation practices in the 

management of agricultural water 

systems. Moreover, as discussed in 

section V.I of this document, this 

proposed rule would not require the 

destruction of habitat or the clearing of 

farm borders around outdoor growing 

areas or drainages. 

9. Consistency With National Organic 

Program 

In accordance with section 

419(a)(3)(E), this proposed rule does not 

include any requirements that conflict 

with or duplicate the requirements of 

the National Organic Program. In 

developing this proposed rule, we 

consulted with technical experts and 

representatives from the National 

Organic Program (Ref. 34). Compliance 

with the provisions of this proposed 

rule would not preclude compliance 

with the requirements for organic 

certification in 7 CFR part 205. 

Moreover, where this proposed rule and 

the National Organic Program would 

include similar or related requirements, 

we propose that our requirements may 

be satisfied concurrently with those of 

the National Organic Program (i.e., to 

the extent the requirements are the 

same, compliance with this proposed 

rule could be achieved without 

duplication). For example, proposed 

§ 112.54(c) would establish multiple 

options for composting processes used 

to treat biological soil amendments of 

animal origin used to grow covered 

produce, including two options 

(§ 112.54(c)(1) and (2)) that are 

consistent with the options available to 

USDA-certified organic farms under the 

National Organic Program regulations in 

7 CFR 205.203(c)(2). 

As another example, the National 

Organic Program application intervals 

for the use of raw manure as a soil 

amendment in 7 CFR 205.203(c)(1) are 

90 days and 120 days before harvest, 

depending on whether the edible 

portion of the crop contacts the soil. 

Proposed § 112.56(a)(1)(i) would require 

a 9 month application interval for use of 

raw manure in the growing of covered 

produce when application is performed 

in a manner that does not contact 

covered produce during application and 

minimizes the potential for contact with 

covered produce after application. 

Proposed § 112.56(a)(1)(ii) would not 

require an application interval for use of 

raw manure in the growing of covered 

produce when application is performed 

in a manner that does not contact 

covered produce during or after 

application. For certified organic farms 

growing produce that would be subject 

to this rule, the National Organic 

Program application intervals would 

run concurrently with the proposed 

application interval in this proposed 

rule, rather than consecutively. Organic 

farms (like other farms) using raw 

manure would either need to wait 9 

months between application and harvest 

and use application methods meeting 

the proposed requirements for avoiding 

and minimizing contact between 

covered produce and raw manure, or 

apply the raw manure in a manner that 

does not contact covered produce 

during or after application. Doing so 

would not jeopardize their compliance 

with the requirements of the National 

Organic Program. 

In addition, this proposed rule would 

establish in proposed § 112.163 that 

records kept for other purposes could be 

used to satisfy the recordkeeping 

requirements in this proposed rule. 

Accordingly, records kept under 7 CFR 

205.103 for the purposes of the National 

Organic Program that contain 

information that would be required in 

records under this proposed rule would 

not need to be duplicated. 

Further, while not critical to our 

conclusion regarding compliance with 

section 419(a)(3)(E) of the FD&C Act, we 

note that the provisions of the proposed 

rule are not in conflict with or 

duplicative of the non-binding 

recommendations of the National 

Organic Standards Board’s Compost Tea 

Task Force (Ref. 36). Certified organic 

farms would be able to comply with the 

provisions of this proposed rule with 

respect to their use of agricultural teas 

while simultaneously meeting or 

exceeding the non-binding 

recommendations in the NOSB Compost 

Tea Task Force Report. 

We seek comment on our approach to 

ensuring that this proposed rule does 

not conflict with or duplicate the 

requirements of the National Organic 

Program while providing the same level 

of public health protection as required 

under FSMA. 

10. Minimizing PRA burden 

In implementing section 419 of the 

FD&C Act through this proposed rule, 

FDA has complied with chapter 35 of 

title 44, United States code (commonly 

known as the ‘‘Paperwork Reduction 

Act’’ (PRA)), with special attention to 

minimizing the burden (as defined in 

section 3502(2) of such Act (44 U.S.C. 

3502(2)) on the facility, and collection 

of information (as defined in section 

3502(3) of such Act (44 U.S.C. 3502(3)), 

associated with the proposed rule. 

Under section 3502(2) of the PRA, 

‘‘burden’’ means the ‘‘time, effort, or 

financial resources expended by persons 

to generate, maintain, or provide 

information to or for a Federal agency.’’ 

Under section 3502(3) of the PRA, 

‘‘collection of information’’ means, in 

relevant part, ‘‘the obtaining, causing to 

be obtained, soliciting, or requiring the 

disclosure to third parties or the public, 

of facts or opinions by or for an agency, 

regardless of form or format, calling for 

* * * answers to identical questions 

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3520 Federal Register / Vol. 78, No. 11 / Wednesday, January 16, 2013 / Proposed Rules 

posed to, or identical reporting or 

recordkeeping requirements imposed 

on, ten or more persons.* * *’’ In 

section X of this document, we discuss 

how this proposed rule complies with 

the requirements of the PRA. In 

addition, in implementing section 419 

of the FD&C Act, we have paid special 

attention to minimizing burden and 

collection of information associated 

with this proposed rule. 

As discussed above, we are proposing 

requirements that provide significant 

flexibility for different sizes and types of 

farms. By making these requirements 

flexible enough to be practicable for 

different sizes and types of farms, the 

proposed rule also avoids creating 

unnecessary information collection 

burden for entities, because farms 

should be able to tailor their 

recordkeeping to their specific 

circumstances while still complying 

with the requirements of the proposed 

rule. 

In addition, as discussed in section 

IV.E. of this document, the only 

requirements we are proposing that 

constitute collections of information are 

those that are necessary to implement 

section 419 of the FD&C Act and for the 

efficient enforcement of the FD&C Act. 

We propose to require records under 

this rule only in instances where 

maintenance of detailed information is 

needed to keep track of measures 

directed at minimizing the risk of a 

known or reasonably foreseeable 

hazards, where identification of a 

pattern of problems is important to 

minimizing the risk of such hazards, or 

where they are important to facilitate 

verification and compliance with 

standards and this cannot be effectively 

done by means other than a review of 

records. These instances are discussed 

in more detail in section IV.E. of this 

document and throughout section V of 

this document. In addition, although we 

recognize their value and encourage 

their use, we are not proposing to 

require farms to conduct operational 

assessments or to develop written food 

safety plans akin to similar 

requirements for facilities subject to 

section 418 of the FD&C Act or our juice 

HACCP or seafood HACCP regulations. 

B. Other Provisions of the Federal Food, 

Drug, and Cosmetic Act 

FDA’s authority for this proposed rule 

also derives from sections 402(a)(3), 

402(a)(4), and 701(a) of the FD&C Act. 

Section 402(a)(3) of the FD&C Act 

provides that a food is adulterated if it 

consists in whole or in part of any 

filthy, putrid, or decomposed substance, 

or if it is otherwise unfit for food. 

Section 402(a)(4) of the FD&C Act 

provides that a food is adulterated if it 

has been prepared, packed, or held 

under insanitary conditions whereby it 

may have become contaminated with 

filth, or whereby it may have been 

rendered injurious to health. Under 

section 701(a) of the FD&C Act, FDA is 

authorized to issue regulations for the 

efficient enforcement of the FD&C Act. 

The proposed rule includes many 

requirements that are necessary to 

prevent food from being adulterated 

(either because it consists in whole or in 

part of a filthy, putrid, or decomposed 

substance, because it is otherwise unfit 

for food, or because it has been held 

under insanitary conditions whereby it 

may have become contaminated with 

filth, or whereby it may have been 

rendered injurious to health). A 

regulation that requires measures to 

prevent food from being held under 

insanitary conditions whereby either of 

the proscribed results may occur allows 

for the efficient enforcement of the 

FD&C Act. See, e.g., regulations to 

require HACCP systems for fish and 

fishery products (21 CFR Part 123) and 

juice (part 120), regulations to require a 

safe handling statement on cartons of 

shell eggs that have not been treated to 

destroy Salmonella organisms and to 

require refrigeration of shell eggs held 

for retail distribution (parts 101 and 

115), and regulations for the production, 

storage, and transportation of shell eggs 

(part 118). 

C. The Public Health Service Act 

In addition to the FD&C Act, FDA’s 

legal authority for the proposed rule 

derives from the PHS Act. Authority 

under the PHS Act for the proposed 

regulations is derived from the 

provisions of sections 311, 361, and 368 

(42 U.S.C. 243, 264, and 271) that relate 

to communicable disease. The PHS Act 

authorizes the Secretary to make and 

enforce such regulations as ‘‘are 

necessary to prevent the introduction, 

transmission, or spread of 

communicable diseases from foreign 

countries into the States * * * or from 

one State * * * into any other State’’ 

(section 361(a) of the PHS Act). (See sec. 

1, Reorg. Plan No. 3 of 1966 at 42 U.S.C. 

202 for transfer of authority from the 

Surgeon General to the Secretary; see 21 

CFR 5.10(a)(4) for delegation from the 

Secretary to FDA.) The provisions in the 

proposed rule are necessary to prevent 

food from being contaminated with 

human pathogens such as Salmonella, 

L. monocytogenes, and E. coli O157, 

and therefore to prevent the 

introduction, transmission, or spread of 

communicable disease from foreign 

countries into the United States, or from 

one state in the United States to another. 

As discussed in section II of this 

document, without appropriate 

prevention steps, certain practices on 

farms can lead to the contamination of 

food with pathogens, increasing the 

likelihood of foodborne illness. We 

tentatively conclude that the proposed 

provisions in this document are 

necessary to prevent the spread of 

communicable disease and to prevent 

food from containing filthy, putrid, or 

decomposed substances; being 

otherwise unfit for food, or being 

prepared, packed, or held under 

insanitary conditions whereby it may 

have become contaminated with filth, or 

whereby it may have been rendered 

injurious to health. 

D. Legal Authority for Records 

Requirements 

We are proposing to use our authority 

under the FD&C Act and the PHS Act to 

institute certain records requirements as 

follows: 

• For covered produce that is 

exempted from the requirements of the 

proposed rule because it receives 

commercial processing that adequately 

reduces the presence of microorganisms 

of public health significance, the 

identity of the recipient that receives 

this produce (§ 112.2); 

• For alternatives that farms may 

establish and use for certain 

requirements of the proposed rule, the 

scientific data and information used to 

support such alternatives (§ 112.12); 

• Documentation of compliance with 

certain requirements related to training 

of personnel (§ 112.30); water 

monitoring and testing (§ 112.50); 

biological soil amendments of animal 

origin (§ 112.60); sanitizing of 

equipment used in growing operations 

for sprouts, or for covered harvest, 

packing, or holding activities 

(§ 112.140), 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 requirements are 

necessary for covered farms to ensure 

their own compliance with these 

aspects of the proposed rule and for 

FDA to ensure that covered farms are 

complying with the same aspects of the 

proposed rule. Therefore, these 

proposed requirements are necessary for 

the efficient enforcement of the FD&C 

Act because they will aid both farms 

and FDA in ensuring that food is not 

adulterated, and are necessary to 

prevent the spread of communicable 

disease because they will aid both farms 

and FDA in ensuring that food does not 

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become contaminated with human 

pathogens. 

In addition to having the authority 

under the FD&C Act and the PHS Act to 

require this recordkeeping, we also have 

the authority to require access to the 

records. Because the underlying 

requirements are necessary to minimize 

the likelihood of adulteration and the 

spread of communicable disease, access 

to records that demonstrate that a farm 

has followed those requirements is 

essential to confirm compliance and 

achieve the full benefits of the rule. We 

also have the authority to copy the 

records when necessary. We may 

consider it necessary to copy records 

when, for example, our investigator may 

need assistance in reviewing a certain 

record from relevant experts in 

headquarters. If we are unable to copy 

the records, we would have to rely 

solely on our investigators’ notes and 

reports when drawing conclusions. In 

addition, copying records will facilitate 

follow up regulatory actions. Therefore, 

we have tentatively concluded that the 

ability to access and copy records is 

necessary to enforce the rule and 

prevent adulteration and the spread of 

communicable disease. In other relevant 

sections of this document, we explain in 

more detail the recordkeeping 

provisions that we believe are necessary 

and, because they are limited to what is 

necessary, that we believe do not create 

an unreasonable recordkeeping burden. 

F. Intrastate Activities 

FDA tentatively concludes that the 

provisions in the proposed rule should 

be applicable to activities that are 

intrastate in character. The plain 

language of section 419 of the FD&C Act 

directs FDA to establish science-based 

minimum standards for the safe 

production and harvesting of fruit and 

vegetable RACs to minimize the risk of 

serious adverse health consequences or 

death. Section 419 does not include a 

limitation to interstate commerce. In 

addition, the exemption provided in 

section 419(f) of the FD&C Act, based in 

part on the proportion of a farm’s sales 

made to restaurants or retail food 

establishments intrastate or within 275 

miles, suggests that Congress intended 

the rule issued under section 419 to 

apply to intrastate commerce because 

otherwise there would be no need to 

provide an exemption for farms whose 

sales are intrastate in character. In 

addition, section 301(vv) of the FD&C 

Act provides that ‘‘[t]he failure to 

comply with the requirements under 

section 419’’, or the causing thereof, is 

a prohibited act. Section 301(vv) does 

not require an interstate commerce 

nexus. Notably, other subsections in 

section 301 of the FD&C Act, and 

section 304 of the FD&C Act (21 U.S.C. 

334) demonstrate that Congress has 

included a specific interstate commerce 

nexus in the provisions of the FD&C Act 

when that is its intent. Accordingly, it 

is reasonable to interpret sections 419 

and 301(vv) of the FD&C Act as not 

limiting the application of the proposed 

rule only to those farms with a direct 

connection to interstate commerce. 

FDA is mindful that its interpretation 

of FSMA and the FD&C Act should not 

cast doubt on the constitutionality of 

those statutes. (See Solid Waste Agency 

of Northern Cook County v. U.S., 531 

U.S. 159 (2001)). FDA has considered 

the relevant provisions of FSMA and the 

FD&C Act, FDA’s responsibilities in 

implementing those statutes, and the 

law interpreting the commerce clause of 

the Constitution (Article I, section 8). 

Congress’s power to legislate under the 

commerce clause is very broad. 

However, such power is not without 

limits, see United States v. Lopez, 514 

U.S. 549, 567 (1995); U.S. v. Morrison, 

529 U.S. 598, 618 (2000), and these 

limits have been construed in light of 

relevant and enduring precedents. In 

particular, in Lopez, supra, the Supreme 

Court acknowledged the continuing 

vitality of Wickard v. Filburn, 317 U.S. 

111 (1942), noting that ‘‘although 

Filburn’s own contribution to the 

demand for wheat may have been trivial 

by itself, that was not ‘enough to remove 

him from the scope of Federal 

regulation where, as here, his 

contribution, taken together with that of 

many others similarly situated, is far 

from trivial.’’’ (514 U.S. at 556.) See also 

Gonzales v. Raich, 545 U.S. 1, 17–25 

(2005). This principle applies to the 

application of sections 419 and 301(vv) 

of the FD&C Act, as added by section 

105 of FSMA. Accordingly, given the 

collective impact on commerce of farms 

that grow, harvest, pack, or hold food 

that is sold in ‘‘intrastate’’ commerce, 

FDA tentatively concludes that such 

farms should be subject to the proposed 

rule unless an exemption from the rule 

applies (for example, if the farm is 

eligible for the qualified exemption in 

proposed § 112.5, or if the farm only 

grows produce exempt 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 action to enforce the act’s 

requirements respecting foods, drugs, 

devices, and cosmetics, any necessary 

connection with interstate commerce is 

presumed. Likewise, this outcome is 

consistent with FSMA’s risk-based, 

preventive approach to food safety 

because the risk presented by unsafe 

food can be great, whether or not the 

food moves from one state to another. 

FDA seeks comment on the number of 

so-called ‘‘intrastate’’ farms that would 

not be exempt from the proposed rule 

either under the proposed exemption in 

§ 112.5 or as a result of growing only 

produce that would be exempt under 

proposed § 112.2. 

E. Relevance of Section 415 of the FD&C 

Act to ‘‘Farm’’ Definition and Related 

Definitions 

Section 419 directs FDA to issue a 

proposed rule ‘‘for the safe production 

and harvesting’’ of certain produce. 

Section 419 does not affirmatively 

identify the businesses to which the 

proposed rule must apply, but requires 

FDA to address ‘‘with respect to 

growing, harvesting, sorting, packing, 

and storage operations * * * soil 

amendments, hygiene, packaging, 

temperature controls, animals in the 

growing area, and water’’ (419(a)(3)(B)); 

frequently uses the term ‘‘farm’’ (e.g., 

section 419(f)); and clarifies that section 

419 does not apply to produce produced 

by an individual for personal 

consumption (section 419(g)) or 

activities of facilities subject to section 

418 (section 419(h)). FDA intends to 

issue a notice of proposed rulemaking 

implementing section 418 of the FD&C 

Act (section 103 of FSMA) in the near 

future. FDA tentatively concludes that 

‘‘activities of facilities subject to section 

418’’ are those activities triggering the 

requirement to register with FDA under 

section 415 of the FD&C Act (21 U.S.C. 

350d), ‘‘Registration of Food Facilities.’’ 

FDA therefore tentatively concludes that 

it is reasonable to apply this proposed 

rule to farms and activities of farm 

mixed-type facilities that are within a 

definition of ‘‘farm’’ consistent with that 

utilized in FDA’s implementation of 

section 415 of the FD&C Act, except to 

the extent that such entities are 

producing fruits and vegetables for their 

own consumption. In the near future, 

we plan to address how we will 

coordinate the definitions in the section 

415 registration regulations with the 

definitions we are proposing for the 

purpose of the produce safety proposed 

rule. Ultimately, FDA intends that the 

activities to be regulated under this 

proposed rule will not trigger the 

requirement to register under section 

415 of the FD&C Act and as a result will 

not be ‘‘activities of a facility subject to 

section 418,’’ consistent with the 

requirement in section 419(h). 

Moreover, the activities within the 

definition of ‘‘farm’’ we propose as part 

of this rulemaking closely track those 

identified in section 419(a)(3)(B), and 

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3522 Federal Register / Vol. 78, No. 11 / Wednesday, January 16, 2013 / Proposed Rules 

this interpretation is consistent with 

section 419(f)’s use of the term ‘‘farm.’’ 

Because section 418(o)(2) of the FD&C 

Act defines the term ‘‘facility’’ for the 

purposes of section 418 to mean only 

those facilities required to register under 

section 415 of the FD&C Act, FDA 

tentatively concludes that Congress 

intended the exemptions from the 

registration requirement set forth in 

section 415 and FDA’s implementing 

regulations in part 1, subpart H 

(including the farm exemption in 

§ 1.226(b)) to be meaningful for the 

purposes of defining section 418’s 

applicability (and in turn, section 419’s 

applicability). Thus, we tentatively 

conclude that activities within a 

definition of ‘‘farm’’ consistent with the 

definition utilized to implement the 

section 415 registration requirement are 

not subject to section 418 of the FD&C 

Act, but activities outside such a 

definition of ‘‘farm’’ are subject to 

section 418 when they cause a facility 

to be required to register with FDA 

under section 415. We discuss the 

proposed definition of ‘‘farm’’ and 

related definitions in section V.A.2.b.i 

of this document. We seek comment on 

these interpretations. 

IV. Regulatory Approach 

A. Qualitative Assessment of Risk 

As discussed below, we are proposing 

to adopt an approach that focuses on the 

likelihood of contamination of produce 

posed by the agricultural practices 

applied to the crop, while exempting 

only the lowest-risk produce. We 

conducted a qualitative assessment of 

risk (QAR) of hazards related to produce 

production and harvesting. The QAR 

indicated that produce commodities are 

potentially subject to similar 

microbiological hazard pathways: 

Commodities can potentially become 

contaminated from, for example, direct 

exposure to contaminated water or soil 

amendment. Therefore, we propose to 

adopt a regulatory approach for 

minimizing the risks associated with 

those hazards and, as appropriate, 

provide flexibility for the use of 

alternative measures that would provide 

the same level of public health 

protection as the proposed standard. 

The QAR addressed various questions 

related to produce safety, including: (1) 

What are the biological hazards of 

concern in produce that can lead to 

serious adverse health consequences or 

death? (2) How does produce become 

contaminated (i.e., routes of 

contamination) during on-farm growth, 

harvesting, and postharvest operations? 

(3) Does the likelihood of contamination 

vary among produce commodity types? 

(4) Does the likelihood of illness 

attributable to produce consumption 

vary among produce commodity types? 

(5) What is the impact of postharvest 

practices on the level of contamination 

at consumption? (6) What on-farm 

interventions are available to reduce the 

likelihood of contamination? (Ref. 2). 

The qualitative assessment of risk 

document is currently being peer 

reviewed and changes can be reasonably 

anticipated based on the peer review. 

The peer review plan is available online 

at http://www.fda.gov/ScienceResearch/ 

SpecialTopics/

PeerReviewofScientificInformation

andAssessments/ucm079120.htm. We 

will consider peer reviewers’ and public 

comments in finalizing the qualitative 

assessment and this proposed rule. 

While data and information available 

to us at this time permitted us to 

conduct only a qualitative (not 

quantitative) assessment, some 

important conclusions can be drawn, 

which provide a basis for our proposed 

science-based minimum standards for 

the safe production and harvesting of 

produce commodities. We provide 

below a brief summary of conclusions of 

the QAR. 

Key conclusions from this assessment 

are: 

• Produce can be contaminated with 

biological hazards, and the vast majority 

of produce-related illnesses are 

associated with biological hazards. 

• The most likely routes of 

contamination from growing, 

harvesting, and on-farm postharvest 

activities are associated with seed (for 

sprouts), water, soil amendments, 

animals, worker health and hygiene, 

and buildings/equipment. 

• Although some types of produce 

have been repeatedly associated with 

outbreaks, all types of produce 

commodities have the potential to 

become contaminated through one or 

more of these potential routes of 

contamination. 

• The specific growing, harvesting, 

and on-farm postharvest conditions and 

practices associated with a produce 

commodity influence the potential 

routes of contamination and the 

likelihood that the given route could 

lead to contamination and illness. Use 

of poor agricultural practices could lead 

to contamination and illness, even 

where the potential for contamination is 

relatively low. 

• Postharvest practices such as 

cooking (and, possibly certain peeling) 

before consumption may have an impact 

on the likelihood of contamination of 

the edible portion and the likelihood of 

illness. 

Hazards of concern in produce—The 

scientific evidence from outbreaks, 

surveys and published literature 

establish that human pathogens (e.g., 

Salmonella, pathogenic E.coli, Shigella, 

Cyclospora) constitute a biological 

hazard with the potential to cause 

serious adverse health consequences or 

death and result in the vast majority of 

foodborne illness known to be 

associated with produce consumption. 

Potential routes of contamination— 

Based on our observations during 

inspections, investigations, and 

surveillance activities and other 

available information, we have grouped 

the possible routes of contamination 

into five major pathways: Water, Soil 

amendments, Animals, Worker health 

and hygiene, and Equipment and 

buildings. Seed is an additional route of 

contamination for sprouts. 

Likelihood of contamination—All 

produce commodities can be 

contaminated before, during, and/or 

after harvest through one or more of the 

potential routes of contamination. 

Although the likelihood of 

contamination varies by commodity, it 

appears to be dependent on the 

practices employed and, to a lesser 

extent, on the characteristics of the 

commodity. There appears to be greater 

variability in the likelihood of 

contamination among commodities 

during growing than during harvest or 

after harvest. 

Likelihood of exposure—Subsequent 

to any contamination on-farm, 

consumer and retail handling practices 

and produce consumption rates affect 

the likelihood that consumers will be 

exposed to contamination. Postharvest 

practices such as cooking (and possibly 

certain peeling) before consumption 

may have an impact on the likelihood 

of exposure if indeed the produce is 

contaminated. 

Risk of illness—Contaminated 

produce has the potential to cause 

illness. However, there are differences 

among commodities in the risk of illness 

primarily based on the routes of 

contamination associated with the 

commodity. 

Produce commodities that are ranked 

as ‘‘higher’’ risk of illness and those 

ranked as ‘‘lower’’ risk of illness share 

some of the same characteristics. Both 

categories include: 

• Crops where the harvestable portion 

grows in the ground; 

• Row crops where the harvestable 

portion grows on or near the ground; 

• Crops where the harvestable portion 

grows above the ground; 

• Crops where the harvestable portion 

grows on trees, high above the ground; 

and 

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• Crops that are generally grown 

without soil. 

Such diversity suggests that sorting 

commodities for risk based only on the 

manner in which commodities grow 

would be inappropriate. This diversity 

also characterizes commodities 

associated with outbreaks. Even within 

a commodity group, physical 

characteristics (such as texture of the 

fruit) of the commodity that could alter 

the potential for contamination and, 

therefore, association with an outbreak, 

do not always appear to do so. 

In summary, some produce types are 

repeatedly associated with reported 

foodborne illness whereas other 

produce types are only intermittently 

associated with foodborne illness. Still 

other produce commodities have not 

been associated with reported foodborne 

illness. Likely factors contributing to the 

likelihood of contamination, exposure, 

and illness include: Agricultural 

practices used during growing, 

harvesting, and postharvest; physical 

characteristics of the crop; consumer 

and retail handling practices (such as 

cooking and peeling); and rates of 

consumption. However, use of poor 

agricultural practices could lead to 

contamination and illness, even where 

the potential for contamination is 

relatively low. 

With regard to water as a route of 

contamination:— 

• Agricultural water can be a source 

of contamination of produce. 

• Public Drinking Water Systems 

(domestically regulated by the EPA) 

have the lowest relative likelihood of 

contamination due to existing standards 

and routine analytical testing. 

• Groundwater has the potential to 

pose a public health risk, despite the 

regulation of many U.S. public wells 

being subject to regulation under the 

Ground Water Regulation. 

• There is a significant likelihood that 

U.S. surface waters will contain human 

pathogens, and surface waters pose the 

highest potential for contamination and 

the greatest variability in quality of the 

agricultural water sources. 

• Susceptibility to runoff significantly 

increases the variability of surface water 

quality. 

• Water that is applied directly to the 

harvestable portion of the plant is more 

likely to contaminate produce than 

water applied by indirect methods that 

are not intended to, or not likely to, 

contact produce. 

• Proximity of the harvestable portion 

of produce to water is a factor in the 

likelihood of contamination during 

indirect application. 

• Timing of water application in 

produce production before consumption 

is an important factor in determining 

likelihood of contamination. 

• Commodity type (growth 

characteristics, e.g. near to ground) and 

surface properties (e.g., porosity) affect 

the probability and degree of 

contamination. 

• Microbial quality of source waters, 

method of application, and timing of 

application are key determinants in 

assessing relative likelihood of 

contamination attributable to 

agricultural water use practices. 

With regard to soil amendments as a 

route of contamination— 

• Soil amendments can be a source of 

contamination to produce 

• Biological soil amendments of 

animal origin have a greater likelihood 

of containing human pathogens than do 

chemical or physical soil amendments 

or those that do not contain animal 

waste (e.g., plant-based soil 

amendments). 

• Human waste is the most likely 

waste to contain human pathogens. 

• Animal waste subject to treatments, 

such as chemical and physical 

treatments and composting, has 

relatively lower levels of human 

pathogens than untreated animal waste. 

• Composting is less likely than 

controlled chemical or physical 

treatments to fully eliminate human 

pathogens from animal waste. 

• Incompletely treated, or recontaminated, biological soil 

amendments of animal origin may also 

contain human pathogens. 

• Human pathogens in untreated or 

composted biological soil amendments, 

once introduced to the growing 

environment, will eventually die off, but 

the rate of die-off is dependent upon a 

number of environmental, regional, and 

other agro-ecological factors. 

• Treatments, such as chemical and 

physical treatments and composting, 

can effectively reduce the levels of 

human pathogens in animal waste. 

• Among application methods, 

application of soil amendments in a 

manner in which they contact the 

harvestable portion of the crop presents 

the greatest likelihood of contamination, 

especially when applied close to 

harvest. 

With regard to animals as a route of 

contamination— 

• Animals can be a source of 

contamination to produce. 

• Animal excreta poses a high 

likelihood of contamination of produce. 

• Excreta from domesticated animals 

poses a greater likelihood of 

contamination of produce than does 

excreta of wild animals. However, 

domesticated animals can be expected 

to be more readily controlled (i.e., kept 

apart from produce growing, harvesting, 

and postharvest areas). 

• Excreta from wild animals that 

rarely associate with human activities 

poses the least likelihood of 

contamination of produce. 

• Human pathogens from animal 

excreta, once introduced to the growing 

environment, can be expected to 

eventually die off; but the rate of die-off 

is dependent upon a number of 

environmental, regional, and other agroecological factors. 

With regard to worker health and 

hygiene as a route of contamination— 

• Humans (i.e., workers and visitors) 

are potential carriers of foodborne 

pathogens and can be a source of 

contamination of produce. 

• Individuals with communicable 

diseases that can be spread via food who 

are engaged in activities in which they 

contact produce or food contact surfaces 

can result in contamination of the 

produce or food-contact surfaces with 

human pathogens. 

• Hand-washing reduces the potential 

for contamination of produce. Its 

efficacy varies depending upon the use 

of soap, the quality of the water, and 

whether or not hands are dried after 

washing. 

• Dirty and damaged gloves may 

contaminate produce. 

• Workers or visitors that touch 

animals can contaminate produce or 

food contact surfaces. 

• Poor hygienic practices, e.g. lack of 

hand washing, can lead to 

contamination of produce. 

• The presence of adequate toilet 

facilities in reasonable proximity to 

growing areas can reduce produce 

contamination. 

With regard to equipment and 

buildings as a route of contamination— 

• Food contact surfaces are potential 

routes of contamination of produce. 

• Food contact surfaces such as 

equipment that are designed and 

constructed to be cleanable minimize 

the potential for contamination of 

produce. 

• Pests in buildings used to grow or 

pack produce can be a source of 

contamination of produce. 

• Waste material can be a source of 

contamination, or may become an 

attractant for pests and thereby act as a 

source of contamination to produce, if 

not properly contained, stored, and 

conveyed. 

The provisions proposed in section V 

of this document reflect the above 

conclusions drawn from our qualitative 

assessment of risk. We seek public 

comment on the QAR, conclusions 

drawn from that assessment, and our 

consideration of those conclusions in 

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3524 Federal Register / Vol. 78, No. 11 / Wednesday, January 16, 2013 / Proposed Rules 

developing the proposed requirements. 

We also request you to submit any data 

or factual information that may help the 

agency to conduct, as warranted, a 

thorough and robust quantitative 

assessment of risk associated with 

produce production and harvesting 

practices. 

B. Focus on Biological Hazards 

Section 419 of the FD&C Act directs 

us to establish science-based minimum 

standards for the safe production and 

harvesting of those types of fruit and 

vegetable raw agricultural commodities 

(RACs) for which we determine that 

such standards minimize the risk of 

serious adverse health consequences or 

death (section 419(a)(1)(A) of the FD&C 

Act). These standards are to be based on 

known safety risks and to include 

procedures, processes, and practices 

that we determine to be reasonably 

necessary to prevent the introduction of 

known or reasonably foreseeable 

biological, chemical, and physical 

hazards into fruit and vegetable RACs 

and to provide reasonable assurances 

that produce will not be adulterated 

under section 402 of the FD&C Act 

(sections 419(b)(1) and 419(c)(1)(A) of 

the FD&C Act). 

As discussed in the QAR, available 

data and information clearly establish 

that human pathogens constitute a 

biological hazard with the potential to 

cause serious adverse health 

consequences or death and result in the 

vast majority of foodborne illness 

known to be associated with produce 

consumption. By contrast, chemical, 

physical, and radiological hazards 

associated with produce rarely pose a 

risk of serious adverse health 

consequences or death for individuals 

that would consume the product (Ref. 

7). Section 419(c)(1)(A) of the FD&C Act 

requires FDA to ‘‘set forth those 

procedures, processes, and practices 

that the Secretary determines to 

minimize the risk of serious adverse 

health consequences or death, including 

procedures, processes, and practices 

that the Secretary determines to be 

reasonably necessary to prevent the 

introduction of known or reasonably 

foreseeable biological, chemical, and 

physical hazards * * * and to provide 

reasonable assurances that the produce 

is not adulterated under section 402 [of 

the FD&C Act].’’ The frequency and 

nature of chemical, physical, and 

radiological hazards in produce are such 

that promulgation of a new regulatory 

regime for their control does not, at this 

time, appear to be reasonably necessary 

to prevent their introduction into 

produce or to provide reasonable 

assurances that produce will not be 

adulterated under section 402 of the 

Act. FDA tentatively concludes that 

existing programs, such as EPA 

registration of pesticides, and State and 

industry efforts to control the presence 

of pesticides and mycotoxins in 

produce, are sufficient to keep these 

hazards under control. In addition, 

under its broader food safety regulatory 

framework, FDA monitors natural toxins 

(e.g., mycotoxins), pesticides, industrial 

chemicals (such as dioxins; cooking or 

heating related chemicals, such as 

acrylamide), and other chemical 

contaminants, and radionuclides in 

foods. 

For these reasons, we tentatively 

conclude that the proposed rule should 

be limited in scope to biological hazards 

and science-based standards necessary 

to minimize the risk of serious adverse 

health consequences or death associated 

with biological hazards. Because of the 

proposed rule’s focus on biological 

hazards, and because of the 

effectiveness of cooking and similar 

processes on the reduction of the 

likelihood of contamination of such 

hazards, as described in the Qualitative 

Assessment of Risk, we also propose to 

exempt produce that is rarely consumed 

raw or that receives commercial 

processing that adequately reduces the 

presence of microorganisms of public 

health significance (see section V.A. of 

this document). 

We request comment on this 

approach, and specifically on whether 

there are practices that are reasonably 

necessary to prevent the introduction of 

known or reasonably foreseeable 

chemical, physical or radiological 

hazards into produce or otherwise to 

provide reasonable assurances that 

produce is not adulterated under section 

402 of the FD&C Act because of 

chemical, physical, or radiological 

hazards. For example, proposed 

§ 112.11 would require covered farms to 

take appropriate measures to minimize 

risks of serious adverse health 

consequences or death from the use of, 

or exposure to, covered produce 

attributable to biological hazards that 

may arise unexpectedly and therefore 

not be reflected in a specific standard 

set forth in proposed subparts C to O of 

this rule, or when there are biological 

hazards specific to a covered farm’s 

location or circumstances for which 

such measures would be appropriate. 

Should § 112.11 also apply, for example, 

in the event of an accident or other 

unexpected event, such as a likelihood 

of radiological contamination relevant 

to a covered farm’s location, to require 

that the covered farm take appropriate 

measures to prevent the introduction of 

radiological hazards into or onto the 

produce or by taking measures to 

provide reasonable assurances that the 

produce is not adulterated under section 

402 of the FD&C Act? Such measures 

might include, for example, preventing 

covered produce from entering 

commerce if it may have been 

contaminated with radiological hazards 

that may render it injurious to health. 

As another example, if a covered farm’s 

land was previously used for another 

activity that may have contaminated the 

soil with chemical hazards such that 

using the land to grow covered produce 

may cause introduction of those hazards 

into or onto the covered produce, 

should proposed § 112.11 require the 

covered farm to take appropriate 

measures to prevent the introduction of 

the chemical hazards into or onto the 

produce or by taking measures to 

provide reasonable assurances that the 

produce is not adulterated under section 

402 of the FD&C Act? Such measures 

might include, for example, collecting 

and analyzing soil samples for residues 

of pesticides that are typically used in 

the production of cotton, if you intend 

to use a former cotton field for produce 

production. We seek comment on 

whether, and to what extent, chemical, 

physical, or radiological hazards should 

be covered within the scope of this rule. 

C. Consideration of Differing Risk of 

Different Commodities and Practices 

Section 419 of the FD&C Act also 

directs us to establish requirements that 

would provide sufficient flexibility to be 

applicable to various types of entities 

engaged in the production and 

harvesting of fruit and vegetable RACs, 

including small businesses and entities 

that sell directly to consumers, and to be 

appropriate to the scale and diversity of 

the production and harvesting of such 

commodities (section 419(a)(3)(A) of the 

FD&C Act). Section 419 further directs 

us to acknowledge differences in risk 

while minimizing, as appropriate, the 

number of separate standards we apply 

to separate foods (section 419(c)(1)(D) of 

the FD&C Act). We considered different 

approaches to determine how we might 

most appropriately respond to these 

directives, informed by the information 

contained in the Qualitative Assessment 

of Risk. These primarily included: 

• Commodity-specific approach— 

covering only those produce 

commodities or commodity groups that 

might be described as posing a relatively 

higher risk of foodborne illness or 

applying different requirements to 

commodity categories based on relative 

risk of foodborne illness represented by 

the commodity category (such as higher, 

moderate and lower risk). A benefit of 

opting to pursue a commodity specific 

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Federal Register / Vol. 78, No. 11 / Wednesday, January 16, 2013 / Proposed Rules 3525 

approach would be a reduction in the 

costs of the proposed rule. Some 

commodities have little or no history of 

links to foodborne illness and, thus, 

exempting them from coverage could 

reduce costs to farmers with little or no 

reduction in calculated benefits from 

the rule. However, because foodborne 

illness outbreaks have regularly been 

associated with commodities that have 

previously not been linked to outbreaks, 

this approach carries the risk of failing 

to prevent future outbreaks. 

• Integrated approach—covering all 

produce commodities except those that 

pose little or no risk of foodborne illness 

and then applying the most stringent 

requirements to agricultural practices 

that pose the greatest likelihood of 

contamination of the produce, 

regardless of the covered produce 

commodity. A benefit of selecting this 

option is that we would cover all 

commodities except those that pose 

little or no risk of foodborne illness, an 

approach that takes into account the 

sporadic and unpredictable nature of 

illness outbreaks, while still being 

sensitive to risk. 

As discussed below, we explored both 

approaches thoroughly using 

information available to us at this time, 

and propose to use an integrated 

approach. Based on available data, we 

have not been able to fully develop a 

commodity-specific approach that we 

believe would adequately minimize risk 

of serious adverse health consequences 

or death from biological hazards in 

produce. However, as discussed in 

section IV.C.1.b., we have tentatively 

identified an approach based on 

outbreak data, and we further explore 

that option in that section. We welcome 

comment on this approach and ask that 

you provide data and factual 

information that would help us to 

further consider developing this or 

another appropriate commodity-specific 

approach. 

1. Commodity-Specific Approaches 

As noted above, there are multiple 

possible approaches that we could take 

with respect to produce. One of them is 

what we refer to as a ‘‘commodityspecific approach’’ in which this rule 

would apply only to those produce 

commodities or commodity groups that 

pose a relatively higher risk of 

foodborne illness. (We could also 

simply apply different or less stringent 

requirements to the relatively lower-risk 

commodities.) In theory, commodities 

might also be grouped into higher, 

moderate, or lower levels of risk with 

different levels of stringency applied to 

each. As discussed in section IV.A. 

above, we attempted to categorize 

commodities and commodity groups by 

risk in our Qualitative Assessment of 

Risk. 

a. Relative Risk Considerations 

To fully explore the viability of a 

commodity-specific approach, we 

reviewed the relative risk of different 

commodities using four such data 

sources: Outbreak data; Pathogen 

surveillance data; Commodity 

characteristics; and Market channels. 

Our analysis shows that each data 

source presents certain gaps that make 

it challenging to develop a commodityspecific approach that would adequately 

minimize risk of serious adverse health 

consequences or death. We explain our 

analysis below and request data and 

factual information on how we might 

address these gaps and further develop 

and consider a commodity-specific 

approach. 

i. Outbreak Data and Commodity Risk: 

We reviewed FDA’s data on producerelated outbreaks and considered 

categorizing commodities or commodity 

groups by risk based on documented 

association of specific produce 

commodities with specific outbreaks of 

human illness (Ref. 2). Using this 

approach, we could exempt certain 

commodities or commodity groups that 

had never been linked to human 

illnesses or were only rarely linked to 

human illness; this would allow us to 

reduce the costs of the rule with little 

or no reduction in calculated benefits. 

However, our QAR also leads us to 

tentatively conclude that past patterns 

of outbreaks by commodity have 

limitations which make it challenging to 

use as a key determining factor in 

establishing the scope of this proposed 

rule or how its provisions apply. We 

briefly discuss the reasons here (please 

refer to the QAR for more information). 

Our QAR concluded that some 

produce types are repeatedly associated 

with reported foodborne illness, 

whereas other produce types are 

intermittently associated with reported 

foodborne illness. Still other produce 

commodities have not been associated 

with reported foodborne illness. As 

such, five commodity groups (leafy 

greens, tomatoes, herbs, melons, and 

sprouts) together account for 77 percent 

of all produce-related outbreaks from 

1996–2010 (Ref. 3). These commodity 

groups also account for 54 percent of 

produce-related illnesses and 56 percent 

of produce-related hospitalizations. 

Sprouts account for a quarter of the 

produce related outbreaks (26%), 15 

percent of the illnesses, 9 percent of the 

hospitalizations, and one death. 

As discussed in the QAR, because 

only a small percentage of outbreaks are 

both reported and assigned to a food 

vehicle, outbreak data may not provide 

a complete picture of the commodities 

upon which we need to focus to 

minimize current and future risk of 

illness. The food vehicle responsible for 

an outbreak is not identified in about 

half of all outbreaks. Identifying the 

vehicle of an outbreak in which the 

vehicle is contained in a multiingredient food (e.g., salsa, salads) is 

particularly challenging. As our abilities 

to detect outbreaks and to identify food 

vehicles responsible for an outbreak 

improve, including refining our 

approach to outbreaks associated with 

multi-ingredient foods, it is likely that 

previously unrecognized outbreak 

vehicles will be identified. A further 

complication to use of outbreak data as 

an indication of commodity risk is that, 

until a food is identified as a vehicle in 

an outbreak, public health officials may 

not be likely to include questions about 

that commodity when investigating an 

outbreak, making the attribution of 

outbreaks to commodities with no 

outbreak history more difficult. 

In addition, as discussed in the QAR, 

our data show that the patterns of 

outbreaks associated with produce 

commodities change over time. Some 

commodities have a continuing and 

repeated pattern of association with 

outbreaks, over multiple years, such as 

tomatoes and leafy greens (Ref. 2). On 

the other hand, occasionally a produce 

commodity is associated with an 

outbreak that had not been previously 

linked to foodborne illness. For 

example, prior to the 2008 Salmonella 

Saintpaul outbreak (Ref. 37), jalapeno 

and serrano peppers had not been 

identified as vehicles in a foodborne 

illness outbreak. Papayas had also not 

been associated with outbreaks, prior to 

an outbreak that occurred in 2011. 

Therefore, a regulatory approach that 

relied on a static list of commodities 

prepared solely from a history of 

outbreaks would not be able to prevent 

future outbreaks in commodities not 

previously associated with an outbreak. 

If we adopted an approach that 

exempted commodities without a 

history of outbreaks, we would likely 

need to add commodities as future 

outbreaks occur. For example, we could 

adopt a ‘‘moving window’’ approach 

that would consider only outbreaks over 

a given time period. For example, we 

could consider only the outbreaks over 

the most recent five years at any given 

time. Using such an approach, produce 

commodities or commodity groups 

might move onto and off of the higher 

risk list over time based on changes in 

outbreak data. The advantage of such an 

approach could potentially be to 

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3526 Federal Register / Vol. 78, No. 11 / Wednesday, January 16, 2013 / Proposed Rules 

recognize and reward efforts by industry 

segments that implement changes in 

practices contributing to reduced 

outbreaks associated with their 

commodities, and provide an incentive 

for other industry segments to enhance 

the safety of their practices. However, 

the adoption of such practices by an 

industry segment does not change the 

risk posed by the commodity in the 

absence of such practices, such as when 

practices are not universally adopted or 

they are discontinued. In the absence of 

those practices, illness outbreaks may 

resume. For example, sprout associated 

outbreaks appeared to decline after 

release of our Sprout Guides in 1999 

and, for three years (2005–2007), there 

were no reported outbreaks associated 

with sprouts, presumably because of 

improved practices during the 

production of sprouts (Ref. 3). However, 

outbreaks have recurred since that time 

period, possibly because practices have 

regressed to some extent or possibly 

because of the entry of new sprout 

growers who were not familiar with the 

voluntary recommendations in the 

Sprout Guides and had not adopted 

them. In late 2008, there was one 

sprout-associated Salmonella outbreak; 

in 2009, a Salmonella outbreak 

associated with sprouts resulted in more 

than 200 illnesses; and in 2010, there 

were 3 outbreaks associated with 

sprouts (Ref. 3). Further, as discussed in 

the QAR, some commodities (e.g., leafy 

greens) are consistently associated with 

outbreaks while others (e.g., grapes, 

jalapeno peppers) are only rarely 

associated with outbreaks. With a 

moving window approach those 

commodities that only intermittently are 

associated with outbreaks may cycle on 

and off the higher risk list, even though 

their risk may not have actually 

changed. For these reasons, we have 

tentatively concluded that a ‘‘moving 

window’’ approach for determining risk 

based on outbreak history is not viable. 

Grouping commodities based on 

outbreak history also has challenges. 

Within a commodity group, 

contamination may have been 

associated with relatively few types of 

produce, such as cantaloupe and 

honeydew melons within the melon 

group, which includes multiple species, 

or more broadly, such as roma, red 

round, plum, and grape tomatoes within 

the tomato group, which consists of 

multiple varieties within a single 

species (Ref. 3). 

Having considered that making 

exemptions solely based on outbreak 

data could significantly reduce the costs 

of the proposed rule with little or no 

reduction in calculated benefits, we 

have not selected this alternative, 

because we do not believe that the past 

history of outbreaks can be fully 

predictive of future outbreaks. 

Historically, outbreaks are sometimes 

linked to commodities that had no 

previous associated illnesses. If we were 

to develop a commodity-specific list of 

covered produce, we could add 

commodities to the list as more data 

became available. We request comment 

on whether this option would 

adequately minimize the risk of serious 

adverse health consequences or death 

and whether it would sufficiently move 

toward a prevention-based food safety 

system. We request comment on this 

determination and on the specific 

approaches we have outlined here. We 

are particularly interested in the 

marginal effects of adopting this 

approach: If we exempted commodities 

based on a history of outbreaks, what 

would the likely reductions in the costs 

of the rule be, and what would the 

likely increase in human illnesses be 

from this approach. 

ii. Pathogen Surveillance Data and 

Commodity Risk: As an alternative to 

categorizing and regulating commodities 

based on outbreak history, we 

considered using data on levels and 

frequency of pathogen detection, such 

as by surveillance sampling assignments 

in specific produce commodities. As 

demonstrated in the QAR, this approach 

would also present a number of 

challenges. Of most importance, our 

contamination data are limited in that 

most sampling programs have focused 

on produce commodities that have an 

existing history of known outbreaks, 

providing little additional information 

about the risk presented by commodities 

that do not have such a history. Given 

the potential for system failure and 

sporadic contamination, it is probable 

that testing of other produce 

commodities may eventually lead to 

positive identification of contamination. 

For example, when we added 

cucumbers to our surveillance sampling 

program in 2009, we found a significant 

number of positive samples for 

Salmonella spp. although, in previous 

years, cucumbers had not been 

identified as the vehicle of a foodborne 

outbreak in FDA’s database. We also 

found pathogens in and on produce 

commodities such as broccoli, culantro, 

rapini, and radicchio that have not been 

currently identified in outbreaks (Ref. 

3). For this reason, we do not believe 

that pathogen surveillance data alone 

can provide sufficient information for a 

risk-based exemption from the proposed 

rule’s provisions. We request comment 

on this determination. 

iii. Commodity Characteristics and 

Commodity Risk: As an alternative to 

categorizing and regulating commodities 

based on outbreak history or 

surveillance data, we also considered 

using characteristics of produce 

commodities themselves, such as 

growth habit. In other words, if, for 

example, the risk of illnesses associated 

with tree fruit, were consistently lower 

than the risk of illness from 

commodities grown in the soil, such a 

distinction might provide the basis of an 

exemption. However, as demonstrated 

in the QAR, we found that it would be 

extremely difficult to make conclusions 

across commodity groups that are 

consistent with outbreak and 

surveillance data, in light of the 

diversity of commodities, practices, and 

conditions across operations. 

Attempts to categorize produce by 

commodity characteristics is 

confounded by the outbreak data, which 

show no consistent pattern that can be 

matched to commodity characteristics 

such as growth habit. As discussed in 

the QAR, the characteristics of 

approximately 20 produce commodities 

associated with outbreaks are diverse 

and include: 

• Crops generally grown without soil, 

such as sprouts; 

• Crops where the harvestable portion 

grows in the ground, such as green 

onions; 

• Row crops where the harvestable 

portion grows on or near the ground, 

such as lettuce, spinach, basil, parsley 

and cantaloupe; 

• Crops where the harvestable portion 

grows above the ground, such as 

tomatoes and chili peppers, raspberries 

and blueberries; and 

• Crops where the harvestable portion 

grows on trees, high above the ground, 

such as mangoes and almonds. 

Moreover, as discussed in the QAR, 

even within what may be a reasonable 

set of commodities to group together, 

physical characteristics of the produce 

that could alter the potential for 

contamination do not always appear to 

do so. For example, within the melon 

group, cantaloupe has a netted rind, 

whereas honeydew has a smooth rind, 

seemingly making it less likely to harbor 

pathogens. However, both have been 

associated with outbreaks (Ref. 3). 

In addition, multiple characteristics 

would have to be considered to create 

commodity groupings, making such an 

approach very complicated. For 

example, while growth characteristics, 

such as distance between the edible 

portion of the plant and the ground, 

may make a commodity less likely to 

become contaminated through certain 

routes, (e.g., tree fruit may be less 

vulnerable to contamination from 

grazing animals), distance from the 

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ground does not necessarily provide an 

increased level of protection against 

other sources of contamination (e.g., 

direct contact with a crop protection 

spray if the spray mix were made using 

contaminated water). Furthermore, once 

the produce commodity is removed 

from the growing area, it may lose any 

safety advantage it had in the field 

based on growth characteristics if it is 

exposed to routes of contamination such 

as poor worker hygiene practices, 

contaminated water, or insanitary food 

contact surfaces. As another example, 

mangoes are an example of a produce 

commodity that may be thought to 

present relatively low risk of foodborne 

illness, but for which poor water quality 

management during insect 

disinfestation hot water treatment and 

cooling as part of harvest, packing, and 

holding resulted in an outbreak (Ref. 

38). Some physical characteristics of 

produce commodities (e.g., netted rind 

of cantaloupe or large, rough surface 

area of some leafy greens) may increase 

the likelihood of contaminants being 

trapped and surviving long enough to 

cause illness, but as noted earlier, these 

characteristics do not necessarily 

determine whether contamination 

occurs or persists. 

For the reasons described here, we 

have tentatively determined that such 

an approach cannot serve as the sole 

basis for a risk-based exemption from 

the proposed rule. We request comment 

on this determination and on whether 

there are known produce characteristics 

that could serve as a reliable and 

practicable indicator of contamination 

and illness risk. We seek comment on 

this issue and data to inform commodity 

categorization. 

iv. Market Channel and Risk: We also 

considered whether different market 

channels might have an impact on the 

likelihood of contamination of produce 

and therefore whether use of certain 

market channels should be a factor in 

covering or regulating produce in this 

proposed rule. In particular, we 

considered whether there is a difference 

in the likelihood of contamination of 

produce that is sold directly to the 

consumer or end user (‘‘direct market 

channels’’) as compared to that of 

produce that is sold into other 

commercial channels. We are not aware 

of any data that would enable us to 

compare the likelihood of 

contamination in these two situations. 

We tentatively conclude that produce in 

both direct market channels and other 

commercial channels are subject to the 

same routes of contamination, although 

the number of opportunities for 

contamination during packing and 

holding may be greater for produce in 

other commercial channels as compared 

to produce in direct market channels if 

there are greater numbers of touch 

points and handlers in these channels 

than there are in direct market channels. 

We seek comment on this tentative 

conclusion. 

Section 419(f) of the FD&C Act 

provides a qualified exemption from 

this proposed rule for many farms 

selling directly to consumers or other 

‘‘qualified end users,’’ and as a result, 

many farms that primarily use direct 

market channels will not be subject to 

the requirements of this proposed rule 

(with qualifications provided by the 

statute). Because the statutory qualified 

exemption addresses market channels as 

a possible risk factor, and because we 

identified no data that would allow us 

to otherwise use market channels as a 

factor in covering and regulating 

produce under this proposed rule, we 

tentatively conclude that we should not 

otherwise use market channels as a 

basis of risk categorization in this 

proposed rule. We seek comment on 

this tentative conclusion. 

b. Considering an Appropriate 

Commodity-Specific Approach 

In the previous section, IV.C.1.a, we 

discuss four different relative risk 

considerations that might be used to 

develop an appropriate commodityspecific approach. Each has a set of 

challenges, as discussed above. Of the 

four, outbreak data provide the most 

direct representation of public health 

burden, even considering the confines 

associated with these data. In this 

section we further explore how outbreak 

data might be used to identify 

commodity groups or specific 

commodities to cover in this proposed 

rule. 

One possible commodity-specific 

approach would be to cover those 

commodity groups that have been 

associated with outbreaks. Commodity 

groups ‘‘associated with outbreaks’’ 

could be identified as, for example, 

commodity groups associated with one 

or more outbreaks during a set period of 

time. The remaining commodity groups 

could then either not be subject to the 

proposed rule, or be subject to the 

proposed rule but with less stringent 

requirements. A commodity-specific 

approach that covers the commodity 

groups associated with outbreaks would 

target the commodity groups that 

present the greatest public health 

burden. However, as discussed above in 

section IV.C.1.a., there are various 

drawbacks with using outbreak data in 

this way. For example, because only a 

small percentage of outbreaks are both 

reported and assigned to a food vehicle, 

outbreak data may not provide a 

complete picture of the commodities 

upon which we need to focus to 

minimize current and future risk of 

illness. 

Another possible commodity-specific 

approach that attempts to account for 

the drawbacks of the above approach 

would be to cover all of the 

commodities that have been identified 

as associated with an outbreak at any 

time. Produce commodities that have 

not been identified as associated with 

an outbreak could then either not be 

subject to the proposed rule, or be 

subject to the proposed rule but with 

less stringent requirements. This option 

would address more than the percent of 

known outbreaks addressed by the 

above approach in that it would address 

all known outbreaks. This approach 

would also significantly reduce the 

costs of the proposed rule by exempting 

produce categories that have never been 

associated with human illness. As 

discussed above, however, outbreaks 

have been associated with commodities 

without an illness history. Although we 

would expect to use additional data to 

update any list we might develop of 

commodities subject to the provisions of 

the rule, we would expect that this 

approach would not minimize the risk 

of occurrence of some number of 

additional outbreaks and illnesses. 

We have discussed limitations with 

each of the above methods of creating a 

risk-based exemption from the rule. We 

could also combine two or more of the 

approaches used above to create a more 

holistic picture of risk. For example, we 

might combine a history of outbreak 

data with the growing characteristics of 

a commodity or class of commodity. 

Such an approach could potentially 

exempt additional commodities that 

pose minimal or no risk (in addition to 

those we already considered in the 

proposed approach: Those specified as 

rarely consumed raw, and those that are 

receive commercial processing that 

adequately reduces the presence of 

microorganisms of public health 

significance). If there were individual 

commodities or classes of commodities 

that have not been linked to human 

illness and we had reason to believe that 

they were unlikely to be linked to 

human illness in the future, we would 

consider exempting these commodities 

or classes of commodities from some or 

all provisions of the rule. This would 

reduce the cost of the rule without 

significantly reducing the calculated 

benefits of the rule. However, we have 

not been able to fully develop an 

approach that might combine a history 

of outbreak data with the growing 

characteristics of a commodity or class 

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3528 Federal Register / Vol. 78, No. 11 / Wednesday, January 16, 2013 / Proposed Rules 

of commodities to create risk-based 

exemptions from the rule and, thus, 

minimize the risk of serious adverse 

health consequences or death. We seek 

comment on this issue. Is there 

information in the QAR that could be 

used to develop such a system of riskbased exemptions? Are there 

commodity characteristics or growth 

conditions that could be used as a basis 

to develop such a system? Do the 

proposed provisions for variances (see 

section V.P. below) adequately address 

this issue? 

We ask for comment on all of the 

above approaches, and we especially 

ask for comment on the likely marginal 

effects of the different risk-based 

exemptions. If we adopted one of the 

approaches above, what would the 

likely reductions in the costs of the 

proposed rule be, and what would the 

likely increases in human illnesses be 

(using our proposed rule as a baseline). 

We also ask for comment on whether 

any of the above approaches would be 

sufficiently protective of the public 

health. 

c. Need for additional data and 

information 

We seek comment on our analysis and 

considerations related to considering an 

appropriate commodity-specific 

approach that would adequately 

minimize risk of serious adverse health 

consequences or death from biological 

hazards associated with produce. We 

also request comment on whether and 

how different relative risk 

considerations, including outbreak data, 

pathogen surveillance data, commodity 

characteristics and/or market channels, 

could be used to develop a commodityspecific approach, and data and factual 

information that would address the 

drawbacks that are discussed in this 

section IV.C. that may be accounted for 

in such an approach. Specifically, 

D Are there specific commodities or 

categories of commodities that should 

be excluded from the scope of the rule, 

based on data related to their relative 

risk considerations? (Note that under 

our proposed integrated approach, we 

propose to exempt certain commodities, 

including a specified list of produce that 

is rarely consumed raw, and produce 

that receives commercial processing that 

adequately reduces the presence of 

microorganisms of public health 

significance; see section V.A.2.a. of this 

rule.) 

Æ For example, the QAR ranked 

certain produce commodities, such as 

bananas and coconuts, as lower risk for 

illness, in part because such 

commodities are peeled or shelled 

before consumption in a manner that 

can be expected not to transfer 

contamination onto the interior, edible 

portion of the commodity. Should such 

commodities be covered by the rule? Is 

coverage of these commodities 

unnecessary? Should they be covered 

but subject to a less stringent set of 

requirements? 

Æ Certain commodities are ranked in 

the QAR as presenting a relatively lower 

likelihood of exposure, in part because 

such commodities have fewer potential 

routes of contamination and/or lower 

potential for contamination. In addition, 

some commodities are not known to 

have been associated with outbreaks. 

Some commodities (for example, pears, 

grapefruit, oranges, and lemons) meet 

both of these criteria, considering the 

rankings and outbreak data used in the 

QAR. Should commodities that meet 

both of these criteria be covered by the 

rule? Is coverage of these commodities 

unnecessary? Should they be covered 

but subject to a less stringent set of 

requirements? How should the rule 

address the changing nature of outbreak 

data over time? 

Æ How should the agency account for 

uncovered commodities in considering 

a commodity-specific approach that 

relies on outbreak data? 

D Are there pathogen surveillance 

data from sampling programs focusing 

on produce commodities that have no 

history of known outbreaks that would 

be useful in considering a commodityspecific approach? 

D Can commodity characteristics be 

used as a basis to consider a 

commodity-specific approach? While 

the outbreak data show no consistent 

pattern that can be matched to 

commodity characteristics such as 

growth habit, our QAR shows that 

produce commodities that are ranked as 

higher risk of illness and those ranked 

as lower risk of illness do share some of 

the same characteristics. A further 

refinement of our assessment might be 

helpful in developing a commodityspecific approach based on commodity 

characteristics. Considering the 

qualitative nature of our assessment, are 

there quantitative data sets available 

that would enable a further refinement 

of our assessment? 

D Are produce in both direct market 

channels and other commercial 

channels subject to the same routes of 

contamination? Is the number of 

opportunities for contamination during 

packing and holding greater for produce 

in other commercial channels as 

compared to produce in direct market 

channels? If yes, is this due to greater 

numbers of touch points and handlers 

in these channels than there are in 

direct market channels, or to other 

factors? 

D Should market channels be used as 

a basis for risk categorization? If so, 

how? Is there a need to consider market 

channels in risk categorization, 

considering that the statutory qualified 

exemption already addresses market 

channels as a possible risk factor? 

D Are other data or information 

available that would otherwise be useful 

in considering a commodity-specific 

approach? 

2. Integrated Approach, as Proposed 

As discussed in section IV.A. above, 

our QAR indicates that some produce 

types are repeatedly associated with 

reported foodborne illness whereas 

other produce types are intermittently 

associated with foodborne illness. Still 

other produce commodities have not 

been associated with reported foodborne 

illness. Likely factors contributing to the 

likelihood of contamination, exposure, 

and illness include: Agricultural 

practices used during growing, 

harvesting, and postharvest; physical 

characteristics of the crop; consumer 

and retail handling practices (such as 

cooking and peeling); and rates of 

consumption. However, use of poor 

agricultural practices could lead to 

contamination and illness, even where 

the potential for contamination is 

relatively low. 

Therefore, we tentatively conclude 

that an integrated approach that focuses 

on the likelihood of contamination of 

produce posed by the agricultural 

practices applied to the crop, while 

exempting the lowest-risk produce, 

would provide the most appropriate 

balance between public health 

protection, flexibility, and appropriate 

management of different levels of risk. 

We tentatively conclude that controls 

should be tailored, taking into account 

the analysis done by the farm in certain 

areas, to the potential routes of 

contamination that each commodity 

presents based on the agricultural 

practices employed, and the 

characteristics of the commodity and 

the environmental conditions under 

which it is grown. 

Based on our QAR, we are able to 

identify certain conditions under which 

produce commodities constitute very 

low to no risk with respect to biological 

hazards. We tentatively conclude that, 

under these conditions, science-based 

minimum standards to minimize the 

risk of serious adverse health 

consequences or death from biological 

hazards in produce are not warranted. 

As described in the QAR, such 

conditions include produce that 

receives commercial processing that 

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adequately reduces the presence of 

microorganisms of public health 

significance (proposed § 112.2(b)); and 

produce commodities that are rarely 

consumed raw (proposed § 112.2(a)(1)). 

In each of these cases the produce can 

be expected to receive commercial 

processing or other treatments that 

significantly minimize the risk of 

serious adverse health consequences or 

death from biological hazards associated 

with such produce. 

In addition, as discussed in section 

V.A. of this document, FDA proposes in 

§ 112.4 to apply this regulation only to 

businesses with an average annual 

monetary value of food sold during the 

previous three-year period of more than 

$25,000 on a rolling basis, based on a 

tentative conclusion that businesses 

with $25,000 or less in sales do not 

contribute significantly to the produce 

market and, therefore, to the volume of 

production that could become 

contaminated. Accordingly, imposing 

the proposed requirements on these 

businesses would have little measurable 

public health impact. In addition to 

these exclusions proposed by FDA, 

section 419(f) of the FD&C Act provides 

a qualified exemption for certain farms, 

which FDA proposes to implement in 

proposed §§ 112.5 and 112.6, and 

subpart R, as discussed in sections V.A. 

and V.R. of this document. 

For produce commodities that would 

be covered within the scope of this rule 

(i.e., ‘‘covered produce’’ as defined in 

proposed § 112.3), we are proposing to 

establish science-based minimum 

standards to minimize the risk of 

serious adverse health consequences or 

death. Given our current understanding 

of existing microbiological hazards and 

current data limitations, as described in 

our QAR, we have determined that a 

regulatory approach that addresses the 

potential likelihood of contamination 

posed by procedures, processes, and 

practices employed in the growing, 

harvesting, packing, and holding of 

produce commodities will be more 

effective and appropriate than an 

approach based on the individual 

commodities’ physical characteristics, 

known record of contamination, or 

known outbreak history. The only 

commodity-specific requirements 

proposed in this rule are those 

designated for sprouts, which have 

unique growing procedures (i.e., warm, 

moist nutrient-rich environment for an 

extended period of time that supports 

pathogen growth in addition to 

sprouting) and, therefore, present a 

unique risk profile (Ref. 16.Ref. 2). For 

this reason, and as discussed in section 

V.M. of this document, we tentatively 

conclude that a specific set of safety 

standards (proposed subpart M) for this 

produce commodity is warranted. 

The requirements of the proposed 

regulation would be based on identified 

routes of contamination and the 

associated practices that affect the 

likelihood that produce becomes 

contaminated: Agricultural practices 

that are more likely to contaminate 

produce would require more stringent 

measures to ensure that the likelihood 

of contamination is sufficiently 

minimized. For example, as discussed 

in section V.E. of this document, we are 

proposing the most stringent standards 

for water that is used in direct contact 

with the harvestable portion of covered 

produce during or after harvest 

activities (when there is little further 

opportunity for pathogen die off) and in 

certain other uses that present 

significant safety risk for the safety of 

the produce (such as irrigation of 

sprouts); less stringent standards for 

water that directly contacts the 

harvestable portion of covered produce 

(other than sprouts) during growing 

activities (when the opportunity for 

pathogen die off is greater); and no 

requirements when water is used during 

growing, but does not contact the 

harvestable portion of covered produce 

(other than sprouts). Similarly, we are 

proposing to prohibit the use on covered 

produce of biological soil amendments 

that present the greatest likelihood of 

pathogen contamination, i.e., untreated 

human waste (Ref. 39). Untreated 

manure or other untreated biological 

soil amendments of animal origin, 

which are less likely to be contaminated 

with human pathogens than human 

waste, but are relatively likely to be 

contaminated (Ref. 35. Ref. 36. Ref. 37), 

would be allowed, subject to stringent 

requirements; manure or other 

biological soil amendments of animal 

origin that have been properly 

composted to reduce the level of 

pathogens contained therein would be 

subject to less stringent requirements; 

and certain chemically or physically 

treated biological soil amendments of 

animal origin that receive more robust 

treatments to eliminate pathogens 

would be subject to the least stringent 

requirements. 

In addition, we are proposing to 

include other measures that would be 

broadly applicable (e.g., personnel 

qualifications and training requirements 

in proposed subpart C, health and 

hygiene requirements in proposed 

subpart D; requirements for equipment, 

tools, buildings, and sanitation in 

proposed subpart L) and the proposed 

standards for these are consistent for all 

covered growing, harvesting, packing, 

and holding operations. 

We tentatively conclude that the 

appropriate way to minimize the risk of 

serious adverse health consequences or 

death is to require all covered farms to 

comply with the standards in this 

proposed rule with regard to all but the 

lowest risk produce. Identifying the 

higher-risk agricultural practices and 

setting standards in which the 

stringency of the requirement tracks the 

risk of the chosen practices is 

appropriate from a public health risk 

mitigation standpoint and would also 

provide an incentive for farmers to 

move to lower-risk practices where such 

options are available. We also expect 

that our proposed approach is more 

workable for row crop farmers who may 

grow multiple produce commodities 

than it would be if we were to assign 

different requirements to specific 

commodities based on the risk of 

foodborne illness associated with those 

commodities. In these types of 

operations, many agricultural practices 

and agricultural inputs (such as water 

sources and distribution systems, soil 

amendments and their application 

methods) tend to be farm-specific and, 

thus, relatively consistent across 

produce commodities on a given farm. 

Requiring different measures from row 

to row based on the produce commodity 

in that row would likely pose a 

considerable burden on such farms. 

Setting standards that enable such farms 

to apply consistent measures to multiple 

crops is consistent with the statutory 

provision in section 418(c)(1)(D) of the 

FD&C Act that directs the agency to 

‘‘acknowledge differences in risk and 

minimize, as appropriate, the number of 

separate standards that apply to separate 

foods.’’ 

D. Framework of the Rule 

In developing a framework for this 

proposed rule we considered various 

models used in proposed and final FDA 

regulations, including those applied in: 

(1) The existing Current Good 

Manufacturing Practice in 

Manufacturing, Packing or Holding 

Human Food regulation (current 21 CFR 

part 110; ‘‘Food CGMP regulation’’); (2) 

the Production, Storage, and 

Transportation of Shell Eggs regulation 

(21 CFR part 118; ‘‘Shell Egg 

Regulation’’); (3) the Hazard Analysis 

and Critical Control Point (HACCP) 

Systems (‘‘juice HACCP’’) regulation (21 

CFR part 120); and (4) the Fish and 

Fishery Products (‘‘seafood HACCP’’) 

regulation (21 CFR part 123). None of 

these regulations applies to fruits and 

vegetables at the point at which we 

propose to regulate such food by this 

regulation (during growing, harvesting, 

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3530 Federal Register / Vol. 78, No. 11 / Wednesday, January 16, 2013 / Proposed Rules 

packing, and holding on farms), but as 

models they are instructive. 

Generally, the Food CGMP Regulation 

sets out mandatory, broad, generallyapplicable practices and conditions that 

are required to be met, and the criteria 

and definitions in that part are 

applicable in determining whether the 

food is adulterated (1) within the 

meaning of section 402(a)(3) of the act, 

in that the food has been manufactured 

under such conditions that it is unfit for 

food, or (2) within the meaning of 

section 402(a)(4) of the act, in that the 

food has been prepared, packed, or held 

under insanitary conditions whereby it 

may have become contaminated with 

filth, or whereby it may have been 

rendered injurious to health. The 

criteria and definitions in that part are 

also applicable in determining whether 

a food violates section 361 of the Public 

Health Service Act. In some instances 

where the appropriate measures are 

universal and well recognized, the 

cGMP requirements are prescriptive 

(e.g., the requirement to remove 

unsecured jewelry at § 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 regulation and the desire 

to provide flexibility for operators to put 

in place measures that are best suited to 

the specifics of their operation, the 

cGMP rule sets out more general 

requirements (e.g., the requirement that 

persons working in direct contact with 

food conform to hygienic practices to 

the extent necessary to protect against 

contamination of the food at § 110.10(b), 

the requirement that food that can 

support the rapid growth of undesirable 

microorganisms be held in a manner 

that prevents the food from becoming 

adulterated at § 110.80(b)(3)). Many 

provisions of the Shell Egg Regulation 

also take a similar approach to the Food 

CGMP Regulation. 

The Juice HACCP and Seafood 

HACCP Regulations set out mandatory 

frameworks through which entities 

subject to those regulations assess the 

hazards that are reasonably likely to 

occur in their products and processes 

and design tailored controls to prevent 

or eliminate them or reduce them to an 

acceptable level. These regulations 

require the development of a plan, 

based on the assessment of hazards, 

which includes monitoring procedures, 

corrective action procedures, 

verification procedures, and 

recordkeeping procedures. The plan 

also includes the identification of the 

critical control points (CCPs) where the 

controls must be applied and critical 

limits, which are the set points for the 

process that must be met to ensure 

product safety. 

The Food CGMP Regulation and the 

Shell Egg Regulation do not use the 

structure applied in the other 

regulations identified here to ensure 

that the conditions and practices are 

keeping hazards in check as anticipated 

(through hazard analysis, establishment 

of critical control points, monitoring, 

corrective actions, verification, and 

recordkeeping in all applicable 

contexts). The Food CGMP Regulation 

preceded the HACCP regulations and is 

generally thought of as a pre-requisite or 

foundation to those regulations. That is, 

it is generally recognized that HACCPtype regulations must build on the 

foundation of a good manufacturing 

practice (GMP)-type regulation in order 

to further reduce the risk of illness or 

injury to consumers associated with 

contaminated produce (Ref. 40 Ref. 41). 

In developing the framework for this 

proposed rule, we considered the 

following: (1) The produce farming 

community is very diverse, including 

very small and large farms, some with 

significant expertise in the area of food 

safety and others with minimal 

knowledge in the area, some located in 

the U.S. and some abroad; (2) there is a 

broad range of crops and agricultural 

practices employed by the produce 

farming community, such that a 

measure for addressing an on-farm route 

of contamination for one produce 

commodity in one region may not be 

practical or effective for another on-farm 

route of contamination, produce 

commodity or region; (3) this proposed 

rule is the first effort by FDA to regulate 

the produce farming community—the 

produce farming community does not 

have the history of regulatory 

interaction with FDA and the same 

experience with food safety regulations 

as does the food manufacturing 

industry; (4) the adequacy of some 

measures to control specific known or 

reasonably foreseeable hazards affecting 

produce is well established, while 

others are poorly studied, suggesting 

that future research may identify 

alternative measures that may be more 

effective and/or efficient; and (5) some 

on-farm routes of contamination occur 

in a relatively controlled environment 

(e.g., a fully or partially enclosed 

building), while others occur in an 

outdoor environment that may be 

beyond the control of the farm (e.g., an 

open field), affecting the ability of the 

farm to take measures that minimize the 

likelihood of contamination. 

Given these considerations, and the 

need to tailor the proposed 

requirements to specific on-farm routes 

of contamination (as discussed in 

section IV.C of this document), we 

propose an integrated approach that 

draws on our past experiences in the 

regulations discussed above. In some 

cases, we propose standards that are 

very similar to those contained in the 

Food CGMP Regulation, especially 

where the routes of contamination are 

well-understood and appropriate 

measures are well-established and 

generally applicable across covered 

produce commodities (e.g., personnel 

qualifications, training, health, and 

hygiene; harvesting, packing, and 

holding activities; equipment, tools, 

buildings, and sanitation). We rely on 

this approach where possible, in part, 

because we tentatively conclude that 

compliance would be more suitable 

with this regulatory framework (given 

the diversity of the industry with 

respect to size, agricultural practices, 

and knowledge of food safety) than 

would be the case with a more complex 

framework such as one that also 

required an individual written plan. 

In other cases, we have proposed 

specific numerical standards against 

which the effectiveness of a farm’s 

measures would be compared and 

actions taken to bring the operation into 

conformance with the standards, as 

necessary (e.g., proposed standards for 

agricultural water in subpart E; 

biological soil amendments of animal 

origin in subpart F; sprout 

environmental testing and spent sprout 

irrigation water testing in subpart M). 

We rely on such a numerical standards 

approach where the effectiveness of 

individual measures (e.g., protection of 

agricultural water sources from 

contamination, establishment of 

application intervals for certain soil 

amendments, and chemical disinfection 

treatment of seeds before sprouting) is 

not complete or fully known and/or 

because much of what affects the onfarm 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 § 112.54) we have 

provided measures that are well 

established to meet the numerical 

standard under a wide range of 

conditions, while also recognizing that 

other measures, if properly validated, 

may also be suitable (see proposed 

§ 112.12, discussed in section V.B. of 

this document). Our proposed use of 

numerical standards is similar to the 

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requirement for egg testing in the Shell 

Egg Regulation. 

In still other cases, we have proposed 

a standard that requires the farm to 

inspect or monitor an on-farm route of 

contamination and take appropriate 

measures if conditions warrant. We rely 

on such a monitoring approach where 

the diversity of conditions that can be 

expected relative to an on-farm route of 

contamination is very high and it would 

be impractical and unduly restrictive to 

set out a standard that specifies the 

appropriate measures for each possible 

circumstance (e.g., requirements for 

monitoring for animal intrusion in 

proposed § 112.83, requirement for 

inspection of agricultural water system 

in proposed § 112.42). In addition, we 

propose this approach in instances 

where further research is needed to fully 

understand the effectiveness of 

measures to mitigate the risk of serious 

adverse health consequences or death. 

Our proposed use of inspection and 

monitoring followed by appropriate 

corrective action is similar to the 

requirement to monitor for rodent 

activity and take corrective action on 

egg farms in the Shell Egg Regulation 

(§ 118.4). 

Finally, in still other cases, we 

propose a standard that requires the 

farm to develop a written plan, 

committing itself to specific measures 

(e.g., sprout environmental testing and 

spent sprout irrigation water testing). 

We propose the use of written plans 

where the details of the measures to be 

taken are more than can be reasonably 

expected to be retained in memory, 

especially where the details may change 

over time and a historical record of the 

evolution of the measures is important 

for the operator to assess whether 

further changes to the measures are 

needed (e.g., changes or rotation in the 

sampling sites for sprout environmental 

testing). Such plans are also important 

for the efficient enforcement of the 

standard as they serve as a clear 

commitment on the part of the operator 

of the farm to a particular course of 

action, against which their actual 

performance can be judged by the 

regulator. Our proposed use of written 

plans in these specific instances is 

similar to the requirement for a written 

Salmonella Enteritidis prevention plan 

on egg farms in the Shell Egg Regulation 

(§ 118.4). 

We performed a quantitative risk 

assessment to estimate the predicted 

effectiveness of some of the provisions 

of the proposed regulation with respect 

to one example commodity and one 

example pathogen (Ref. 42). This 

quantitative risk assessment evaluated 

the combination of fresh-cut lettuce, 

enterohemorrhagic E. coli (EHEC), and 

irrigation water (with and without 

proposed measures in place), and 

concluded that a number of variables 

may influence the predicted EHEC 

illnesses associated with fresh-cut 

lettuce, as defined by the model 

scenarios that included contamination 

from irrigation water and other 

environmental sources on the farm, and 

changes in the contamination during the 

product life cycle from farm to 

consumption. The quantitative risk 

assessment document is currently being 

peer reviewed and changes can be 

reasonably anticipated based on the 

peer review. The peer review plan is 

available online at http://www.fda.gov/

ScienceResearch/SpecialTopics/ 

PeerReviewofScientific

InformationandAssessments/ 

ucm079120.htm. We will consider peer 

reviewers’ and public comments in 

finalizing the quantitative risk 

assessment and this proposed rule. 

This rulemaking is not intended to 

address ‘‘hazards that may be 

intentionally introduced, including by 

acts of terrorism.’’ (§ 418(b)(2) of the 

FD&C Act). FDA plans to implement 

section 103 of FSMA regarding such 

hazards in a separate rulemaking in the 

future. FDA tentatively concludes that 

intentional hazards likely will require 

different kinds of controls and would be 

best addressed in a separate rulemaking. 

However, we request comment on 

whether we should include standards 

related to preventing economically 

motivated intentional adulteration of 

produce in this rule. Is economically 

motivated adulteration of produce 

reasonably likely to occur and, if so, by 

what mechanisms may potential 

hazards be intentionally introduced in 

produce for economic reasons? If such 

adulteration is reasonably likely to 

occur, what standards should FDA 

consider for preventing such 

adulteration? 

E. Records 

We are proposing to require that farms 

keep records as a component of the 

above described standards, under 

certain, limited circumstances. In 

determining those circumstances in 

which records are necessary, we 

considered the statutory direction in 

section 419(c)(1)(C) of the FD&C Act to 

comply with the Paperwork Reduction 

Act (44 U.S.C. 3501 et seq.) ‘‘with 

special attention to minimizing’’ the 

recordkeeping burden on the business 

and collection of information as defined 

in that act. 

Records are useful for keeping track of 

detailed information over a period of 

time. Records can identify patterns of 

problems and, thus, enable a farm to 

find and correct the source of problems. 

Records are also useful for investigators 

during inspections to determine 

compliance with requirements (e.g., by 

FDA investigators to determine 

compliance with requirements that 

would be established by this rule, or by 

a third party auditor that a farm or 

retailer may voluntarily engage under a 

business arrangement between the farm 

and the retailer). We propose to require 

records in instances where they are 

important to facilitate verification and 

compliance with standards and this 

cannot be effectively done by means 

other than a review of records; where 

identification of a pattern of problems is 

important to minimizing the likelihood 

of contamination; and where 

maintenance of detailed information is 

needed by the operator in order to 

minimize the risk of contamination and 

demonstrate their compliance. 

F. Farm-Specific Food Safety Plans 

Each farm has a unique combination 

of size, climate, crops grown, current 

and previous use of its own land and 

nearby land, sources of agricultural 

water, growing, harvesting, packing, and 

holding practices, animal grazing, 

potential for domestic and wild animals 

to enter growing or packing areas, and 

sewage or septic system. Relevant 

documents on produce safety, such as 

our GAPs Guide (Ref. 10), industry 

CSGs for melons, tomatoes, leafy greens, 

and green onions (Ref. 43. Ref. 44. Ref. 

45. Ref. 46), the CA and AZ LGMA (Ref. 

31. Ref. 32), the AFDO Model Code of 

Produce Safety (Ref. 20), the Codex 

Guide (Ref. 47), and Industry 

Harmonized GAPs (Ref. 48. Ref. 49) 

recommend that a farm tailor its food 

safety practices to the practices and 

conditions at its individual operation. In 

addition, many of these documents 

explicitly recommend that a farm 

conduct an assessment of its growing 

environment and may specify when 

assessments should be done (e.g., before 

planting, during production, and 

immediately prior to harvest) to identify 

potential food safety hazards in light of 

its particular commodities, practices 

and conditions (Ref. 43. Ref. 44. Ref. 45. 

Ref. 46. Ref. 40. Ref. 47). 

Several of these documents further 

recommend that a farm use the findings 

of its assessment to help establish a plan 

to control potential hazards (Ref. 43. 

Ref. 46. Ref. 48. Ref. 45. Ref. 49. Ref. 28. 

Ref. 18)(Ref. 50. Ref. 51). For example, 

the introduction to the AFDO Model 

Code notes that a food safety plan 

should be commensurate with the size 

and complexity of an operation and the 

inherent risks of the commodities 

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grown, along with site specific practices 

and conditions. The purpose of a food 

safety plan is to establish measures 

designed to prevent the introduction of 

known or reasonably foreseeable food 

safety hazards into or onto produce in 

light of the crops, practices, and 

conditions at the physical location of 

the farm and would include, for 

example, measures applicable to an 

individual farm for agricultural water, 

animal grazing, and any specific hazards 

identified in the recommended 

operational assessment. The FDA draft 

CSGs recommend developing and 

maintaining written food safety plans 

and SOPs for areas such as handling and 

storage practices, field, facility, and 

vehicle cleaning and sanitation, and 

employee training programs. A number 

of comments to the 2010 FR notice 

maintained that the most effective 

approach to produce safety would be 

one that incorporates food safety plans 

developed at the operational level. 

Conversely, another group of comments 

questioned the need for some industry 

segments, such as small farms or 

growers of ‘‘low risk’’ commodities to 

develop or implement food safety plans. 

The above-mentioned documents 

provide guidance or recommendations 

for operators to consider and, as such, 

do not represent requirements that must 

be met. We recognize that requiring 

covered farms to conduct a hazard 

analysis and develop a food safety plan 

at the level required in our juice and 

seafood HACCP regulations, or 

prescribed by section 418 of FSMA for 

food manufacturing/processing 

facilities, may not be feasible. We also 

recognize that, at this time, only limited 

tools are available to help with the 

development of on-farm food safety 

plans. 

Also as noted above, this proposed 

rule is the first effort by FDA to regulate 

the produce farming community. We 

have tentatively concluded, in part 

based on the statutory direction in 

section 419 to establish ‘‘minimum 

science-based standards,’’ and in 

recognition of the direction to pay 

special attention to minimizing 

recordkeeping burden and collection of 

information, that the most appropriate 

approach for this proposed rule is to 

establish standards of the type described 

in section D above. We are not 

proposing to require farms to conduct 

operational assessments or to develop 

food safety plans akin to similar 

requirements for facilities subject to 

section 418 of FSMA or our juice 

HACCP or seafood HACCP regulations. 

We acknowledge that operational 

assessments and food safety plans have 

a prominent place in many public and 

private produce guidance documents, as 

discussed above. 

The importance of tailoring what you 

do at an individual operation to your 

commodities, practices and conditions 

is commonly accepted, and an 

operational assessment and food safety 

plan could be valuable tools for farms to 

select and implement those 

recommendations which are appropriate 

for their circumstances. While we are 

not proposing to require farms to 

conduct an operational assessment or 

develop a food safety plan, we do 

recommend that farms do so, because 

this could help farms be more effective 

in protecting the safety of their produce. 

Further, we request comment on 

whether we should require that some or 

all covered farms perform operational 

assessments and/or develop a food 

safety plan, and if only some, what 

criteria should be used to separate those 

to whom the requirement would apply 

from those to whom it would not. 

G. Foreign Farms 

The proposed rule would apply to 

foreign farms that meet the criteria to be 

covered farms and that grow, harvest, 

pack, or hold covered produce for 

import into the United States. This is 

protective of public health, as foreign 

farms have been implicated in 

foodborne illness outbreaks associated 

with contaminated produce consumed 

in the United States (Ref. 3). This is also 

consistent with the requirements of 

section 419 of the FD&C Act, which 

clearly contemplates that the rule issued 

under that authority will apply to 

foreign farms. This is apparent in 

sections 419(c)(1)(F) and (c)(2), which 

provide for a variance process in which 

states or foreign countries from which 

food is imported into the US may 

request variances from FDA. Foreign 

countries would not be eligible to 

request variances from this rule if 

Congress did not intend the rule to 

apply to farms in foreign countries. 

H. Consistency With Codex Guidelines 

In developing our proposed approach, 

we considered the recommendations of 

relevant Codex guidelines, specifically, 

the Codex Code of Hygienic Practice for 

Fresh Fruits and Vegetables (CAC/RCP 

53–2003) (the Codex Code). Many of the 

provisions proposed in this rule are 

parallel to or consistent with the 

recommendations in the Codex Code. 

For example, like our proposed 

approach of focusing on biological 

hazards, the Codex Code (while 

intended to help control microbial, 

chemical and physical hazards 

associated with production of fresh 

fruits and vegetables) pays particular 

attention to minimizing microbial 

hazards. It concentrates on microbial 

hazards and addresses physical and 

chemical hazards only in so far as they 

relate to good agricultural and 

manufacturing practices. The Codex 

Code recommends measures applicable 

to all stages of the production of fresh 

fruits and vegetables, from primary 

production to packing, with a particular 

emphasis on those intended to be 

consumed raw (Section 2.1 of the Codex 

Code). In proposed § 112.2(a)(1), we 

propose to exempt a specified list of 

produce that is rarely consumed raw 

from the scope of this rule. Similarly, 

for those commodities not cooked before 

consumption, the Codex Code 

recommends a set of broadly applicable 

minimum standards, with risk-based 

adjustments. 

With respect to agricultural water, the 

Codex Code recommends the 

assessment of agricultural water for 

suitability for use; special attention to 

irrigation water that is directly applied 

to edible portion, especially close to 

harvest; and use of clean water for 

initial stages followed by potable water 

for later stages during and after harvest, 

including cooling (Section 3.2.1.1 of the 

Codex Code). Many of the proposed 

provisions described in section V.E. of 

this document are consistent with these 

recommendations. 

As another example, the Codex Code 

recommends that personnel follow 

health and hygiene requirements and 

that toilet and hand washing and drying 

facilities be provided during and after 

harvest, which are reflected in the 

proposed provisions described in 

section V.D. of this document. In 

addition, the proposed provisions 

described in section V.L. of this 

document and the Codex Code both 

recognize the importance of proper 

design, construction, maintenance and 

cleaning of buildings and equipment in 

ensuring produce safety. 

Moreover, the Codex Code 

recommends that ‘‘manure, biosolids 

and other natural fertilizers which are 

untreated or partially treated may be 

used only if appropriate corrective 

actions are being adopted to reduce 

microbial contaminants, such as 

maximizing the time between 

application and harvest of fresh fruits 

and vegetables’’ (Section 3.2.1.2 of the 

Codex Code). The recommendation to 

consider maximizing time between 

application of untreated amendments 

and harvest is reflected in proposed 

provisions described in section V.F. of 

this document, in particular proposed 

§ 112.56, which stipulates application 

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intervals for different biological soil 

amendments of animal origin. 

The Codex Code also recommends 

that ‘‘existing practices should be 

reviewed to assess the prevalence and 

likelihood of uncontrolled deposits of 

animal faeces coming into contact with 

crops. Considering this potential source 

of contamination, efforts should be 

made to protect fresh produce growing 

areas from animals. As far as possible, 

domestic and wild animal should be 

excluded from the area’’ (Section 3.1 of 

the Codex Code). We believe that the 

proposed provisions in § 112.82, which 

requires an adequate waiting period 

between grazing by working animals 

and harvesting when under the 

circumstances there is a reasonable 

probability that grazing or working 

animals will contaminate covered 

produce, and § 112.83, which requires 

monitoring for wild animal intrusion 

and assessment of safety of harvest 

where significant intrusion is evident if 

under the circumstances there is a 

reasonable probability that animal 

intrusion will contaminate covered 

produce, are consistent with (though not 

identical to) these Codex 

recommendations. 

Furthermore, the proposed 

requirements related to the maintenance 

of records (described in section V.O. of 

this document) are in concert with the 

Codex documentation and records 

recommendations for growers and 

packers, which states: ‘‘Growers should 

keep current all relevant information on 

agricultural activities such as the site of 

production, suppliers’ information on 

agricultural inputs, lot numbers of 

agricultural inputs, irrigation practices, 

use of agricultural chemicals, water 

quality data, pest control and cleaning 

schedules for indoor establishments, 

premises, facilities, equipment and 

containers. Packers should keep current 

all information concerning each lot such 

as information on incoming materials 

(e.g. information from growers, lot 

numbers), data on the quality of 

processing water, pest control 

programmes, cooling and storage 

temperatures, chemicals used in 

postharvest treatments, and cleaning 

schedules for premises, facilities, 

equipment and containers, etc.’’ 

(Section 5.7 of the Codex Code). In the 

discussion throughout section V of this 

document, we point out where the 

proposed provisions are consistent with 

these and other recommendations of the 

Codex Code. 

I. Product Testing as a Strategy To 

Control Pathogens 

We considered requiring 

microbiological product testing either 

routinely or under specific conditions as 

a strategy to minimize known or 

reasonably foreseeable hazards. While 

not widely adopted, product testing is 

being used by some in the produce 

industry. Some produce buyers for retail 

distributors require routine microbial 

testing of product as a condition of sale 

in their purchasing specifications (Ref. 

52). Individual fresh-cut produce 

companies began product testing in 

response to the 2006 E. coli O157:H7 

outbreak associated with bagged fresh 

spinach (Ref. 53). At least one company 

is reported to use product testing to 

verify the efficacy of good agricultural 

practices programs and to prevent 

contaminated product lots from entering 

commerce (Ref. 52). The California 

Leafy Greens Marketing Agreement 

requires crop testing for E. coli O157:H7 

and Salmonella spp. whenever a crop 

has been directly contacted with water 

that exceeds the agreements’ acceptance 

criteria for generic E. coli (Ref. 31). 

Product testing, especially 

microbiological testing, for process 

control purposes presents several 

challenges. Pathogen prevalence in 

produce as a result of contamination 

events that occur during growing, 

harvesting, packing, or holding on farms 

are generally temporally intermittent, 

non-homogeneous in a lot or a field, and 

at low concentrations (Ref. 54). 

Therefore, unlike some processed foods 

that may consist of batches of 

homogeneous material (e.g., bulk flour, 

milk, juice), produce are best thought of 

as individual units, and while a positive 

test result for one unit does raise 

concern about the rest of the lot or the 

field subject to the same conditions, 

procedures, processes, and practices, 

any contamination present in one unit 

may not have necessarily spread to 

other units. In addition, it is generally 

recognized that negative product test 

results do not necessarily indicate the 

absence of a hazard, particularly when 

the hazard is present at very low levels 

and is not uniformly distributed (Ref. 

55. Ref. 56). Sampling plans intended to 

ensure detection of contamination with 

a reasonable assurance of success in 

produce lots or fields can be costprohibitive, and may not be effective for 

use in produce. For example, for any 

given contamination rate, the 

probability of detecting Salmonella 

increases with the number of samples 

tested and it is not feasible to identify 

low levels of contamination in an 

individual lot. For example, when 30 

samples in a lot are tested, the 

probability of detecting Salmonella is 1 

percent when the contamination rate is 

1 in 3000, 26 percent when the 

contamination rate is 1 in 100, and 96 

percent when the contamination rate is 

1 in 10 (Ref. 57). Both industry and FDA 

survey data indicate that contamination 

rates in produce (melons, greens, 

tomatoes), while variable, are typically 

very low (Ref. 58. Ref. 59). In addition, 

microbial testing can only detect the 

pathogens that the analytical procedures 

are designed to detect. Testing instead 

for indicator organisms may be a viable 

option, but is not without challenges, as 

discussed in section V.E.2. of this 

document. 

Another factor affecting the utility of 

product testing for pathogens as a 

control measure is that FDA 

recommends, and it is generally 

industry practice, to hold any batch of 

product from which samples are taken 

for testing to prevent the need for a 

recall should the test results 

demonstrate the presence of a pathogen. 

With a highly perishable product as is 

the case for most produce, storing 

product during such analyses would 

significantly reduce the shelf-life of the 

product. For these reasons, we 

tentatively conclude that product testing 

would be impracticable as a component 

of science-based minimum standards 

proposed in this rule except as set forth 

in proposed subpart M under certain 

circumstances for sprouts. 

J. Effective Dates 

We are proposing that the effective 

date of this rule would be 60 days after 

the date of publication of the final rule 

in the Federal Register with staggered 

compliance dates. The effective date is 

the date that provisions in the rule affect 

the current CFR. 

An effective date of 60 days after date 

of publication of the final rule in the 

Federal Register would be consistent 

with the effective dates in recent FDA 

rules directed to food safety. See, e.g., 

Federal Register of July 9, 2009 (74 FR 

33029 at 33030), establishing an 

effective date of September 8, 2009, for 

a final rule for the prevention of 

Salmonella Enteritidis in shell eggs 

during production, storage, and 

transportation; and Federal Register of 

June 25, 2007 (72 FR 34751 at 34752), 

establishing an effective date of August 

24, 2007, for a final rule for current good 

manufacturing practice in 

manufacturing, packaging, labeling, or 

holding operations for dietary 

supplements. 

K. Compliance Dates 

We are proposing that the compliance 

dates for entities subject to the rule 

would be based on the size of a farm 

and the effective date of the 

requirement, with additional flexibility 

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for compliance with proposed 

provisions for water quality 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 

businesses (those subject to proposed 

part 112 and, on a rolling basis, the 

average annual monetary value of food 

sold during the previous three-year 

period is no more than $250,000, as 

defined in proposed § 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 below). The compliance date 

for very small businesses would not be 

in conflict with the requirement in 

section 419(b)(3)(B) of the FD&C Act for 

the regulations promulgated under 

section 419 to apply to very small 

businesses ‘‘after the date that is 2 years 

after the effective date of the final 

regulation. * * *’’ because this 

requirement specifies that the 

regulations shall apply after, not on, the 

date that is 2 years after the effective 

date. To provide additional flexibility to 

small businesses, we would provide two 

more years for very small businesses to 

comply with the rule than is required 

under section 419(b)(3)(B). Providing an 

extended compliance period to very 

small businesses as a means of 

providing additional flexibility is 

consistent with our approach to 

compliance dates in recent rules 

directed to food safety. (See, e.g., 74 FR 

33029 at 33034 and 72 FR 34751 at 

34752.) 

The compliance date for small 

businesses (those subject to proposed 

part 112 and, on a rolling basis, the 

average annual monetary value of food 

sold during the previous three-year 

period is no more than $500,000, as 

defined in proposed § 112.3(b)(2)) 

would be three 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). The compliance date 

for small businesses would not be in 

conflict with the requirement in section 

419(b)(3)(A) of the FD&C Act for the 

regulations promulgated under section 

419 to apply to small businesses ‘‘after 

the date that is 1 year after the effective 

date of the final regulation. * * *’’ 

because this requirement specifies that 

the regulations shall apply after, not on, 

the date that is 1 year after the effective 

date. To provide additional flexibility to 

small businesses, we would provide two 

more years than is required under 

section 419(b)(3)(A). Providing an 

extended compliance period to small 

businesses as a means of providing 

additional flexibility is consistent with 

our approach to compliance dates in 

recent rules directed to food safety. (See, 

e.g., 74 FR 33029 at 33034 and 72 FR 

34751 at 34752.) 

The compliance date for all other 

farms subject to the rule would be two 

years from the effective date (with the 

exception of compliance with §§ 112.44, 

112.45, 112.50(b)(5), 112.50(b)(6), and 

112.50(b)(7), as discussed below). 

The compliance dates for water 

quality requirements in proposed 

§ 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 time to cope 

with implementation of the water 

quality testing, monitoring, and related 

record-keeping provisions. This 

additional compliance period would 

also be expected to permit farms to 

consider identifying alternatives to the 

standard in proposed § 112.44(b) and 

developing adequate scientific data or 

information necessary to support a 

conclusion that the alternative would 

provide the same level of public health 

protection as the standard that would be 

established in this part, and would not 

increase the likelihood that the covered 

produce will be adulterated under 

section 402 of the FD&C Act, in light of 

the farm’s covered produce, practices, 

and conditions. The extended 

compliance dates for the water quality 

testing, monitoring, and related record 

keeping requirements in proposed 

§§ 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 for an exemption 

from most requirements of the rule, 

because such farms have modified 

requirements (proposed § 112.6) to 

which they would be subject on the 

relevant compliance date. 

We seek comment on these proposed 

implementation periods. In addition, 

given that activities related to produce 

production, harvesting, packing, and 

holding may be affected by the produce 

growing season, we seek comment on 

whether these compliance dates 

sufficiently address any issues related to 

the seasonal nature of produce-related 

activities. 

V. The Proposal 

A. Subpart A—General Provisions 

As proposed, subpart A contains 

provisions that establish the scope of, 

and definitions applicable to, this 

regulation, and identifies who is subject 

to the requirements of this part. This 

subpart also describes the proposed 

modified requirements and procedures 

governing qualified exemptions from 

this rule. 

1. Comments Related to Proposed 

Provisions 

We received several comments in 

response to the 2010 FR notice that 

addressed issues relevant to the general 

scope of this proposed rule. Some 

comments requested that tree crops be 

exempt from this regulation. For 

example, an apple grower asserted that 

apples are not as susceptible to E. coli 

and other pathogens as are lettuce and 

tomatoes, and therefore they should not 

be subject to the same controls and 

restrictions. Additionally, one grower 

stated that citrus fruits should be 

exempt because citrus fruits have not 

been identified to be the source of an 

incident of food-borne illness, a 

majority of such produce does not touch 

the ground, citrus fruit are washed 

during the packing process, and the peel 

is rarely consumed raw. Several 

comments from produce associations 

requested removal of watermelons from 

the ‘‘melon’’ category, stating that they 

should have their own category since 

they have a different risk profile from 

other melons. In addition, comments 

from several tree nut growers stated that 

some tree nut commodities should have 

less rigorous requirements or be exempt. 

As we explained in Section IV.C, we 

tentatively concluded that an approach 

that considers both the risk associated 

with the commodity and that associated 

with the agricultural practices applied 

to the crop under the conditions in 

which it is grown, would provide the 

most appropriate balance between 

public health protection, flexibility, and 

appropriate management of different 

levels of risk. Under this approach, we 

considered available information on 

outbreaks and contamination as well as 

existing evidence on characteristics of 

the commodity (such as whether the 

commodity grows on trees or has a 

smooth rind). This evidence informed 

the proposed requirements, but we have 

tentatively concluded that limiting the 

scope of this rule based on outbreak 

data or on the levels of frequency of 

pathogen detection alone would not 

adequately address the risk of serious 

adverse health consequences or death. 

Therefore, as discussed in section 

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V.A.2.a. of this document, we are 

proposing to cover apples, citrus fruits, 

watermelons, and tree nuts in this 

proposed rule. Because the scope and 

stringency of the regulatory 

requirements depends in several cases 

on the types of practices employed 

within operations, producers of 

different commodities who use different 

practices will not be subject to all of the 

same controls and restrictions. We seek 

comment on our proposed approach. 

Because our regulatory approach does 

not depend on categorizing 

commodities based on risk profiles, we 

do not see the need to distinguish 

among fruits, including watermelons, on 

this basis. We do note, however, that in 

proposed § 112.1(b)(1) we have listed 

watermelons separately from other 

melons. While we propose to cover tree 

nuts that do not meet the criteria we 

propose for ‘‘rarely consumed raw’’ (see 

section V.A.2.a) in this proposed rule, 

such as walnuts and almonds, we 

recognize that many of these tree nuts 

receive commercial processing to 

adequately reduce pathogens and, thus, 

may be eligible for an exemption under 

proposed § 112.2(b) (discussed in 

section V.A.2.a. of this document). Our 

main food safety concerns relevant to 

on-farm growing, harvesting, packing, 

and holding of tree nuts pertain to those 

tree nuts that would be sold raw and 

untreated. We request comments on our 

treatment of tree nuts in this proposal. 

We also received comments regarding 

various activities performed on produce 

in relation to the scope of this proposed 

rule. One comment stated that 

‘‘processing’’ should not refer to rinsing 

heads of lettuce or bunches of greens 

before they are packed for market, but 

rather should be defined specifically to 

include other processes that appear to 

involve additional risk to the consumer. 

Some comments suggested that no 

grower should be exempt from these 

food safety regulations, whereas another 

stakeholder stated that the produce 

safety standards must be very clear as to 

what constitutes produce processing 

versus produce preparation for market 

acceptance and that Part 110 should be 

reserved for situations where extensive 

commingling, cutting, washing and 

bagging of produce are practiced. 

Finally, a comment suggested that 

growers who deliver produce to the 

consumer within 24–30 hours should be 

exempt from this regulation. As 

discussed in section III.F. of this 

document and further in section 

V.A.2.b.i below, this proposed rule 

would apply to activities of farms and 

farm mixed-type facilities that are 

within the definition of ‘‘farm’’ 

proposed here. A farm or farm mixedtype facility that washes its own 

covered produce would be harvesting 

within the farm definition and therefore 

that activity would be covered by this 

proposed rule unless another exemption 

applied. However, a farm mixed-type 

facility that washes covered produce not 

grown on that farm or another farm 

under the same ownership for 

distribution into commerce would be 

engaging in an activity outside the farm 

definition (i.e., a manufacturing/ 

processing activity). Such activities 

would not be subject to this rule but 

instead would be subject to section 418 

of the FD&C Act. 

As discussed in section I of this 

document and the QAR, produce is 

vulnerable to contamination by 

pathogens, which can occur at various 

points during growing, harvesting, 

packing, and holding. Although 

contamination usually occurs in low 

doses, even low doses of some of these 

harmful pathogens can result in human 

illness or death (Ref. 60). Thus, if 

produce is contaminated with a 

pathogen, there is a reasonable 

possibility that the amount of the 

pathogen present will be enough to 

cause serious adverse health 

consequences or death to a consumer 

even without an extended time period 

before consumption for the pathogen to 

grow and multiply. In addition, even in 

cases where the delivery time may not 

exceed 24–30 hours, consumers and 

other recipients may store produce (in a 

refrigerator or otherwise) thereafter and 

not consume it immediately, allowing 

additional time for pathogen growth. 

Therefore, FDA tentatively concludes it 

would not be appropriate to exempt any 

farms from this proposed rule based on 

the speed of their deliveries to the 

consumer. 

2. Proposed Requirements 

a. Food Covered by This Rule 

This proposal is applicable to certain 

farm activities performed on certain 

produce for use as human food. Section 

105 of FSMA does not specify whether 

the rulemaking conducted under that 

section should apply to human food, 

animal food, or both. The general 

rulemaking requirements in 

419(a)(1)(A), (b)(1), and (c)(1)(A) 

authorize FDA to establish standards for 

the safe production and harvesting of 

fruits and vegetables that are raw 

agricultural commodities for which the 

Secretary has determined that such 

standards minimize the risk of serious 

adverse health consequences or death. 

FDA tentatively concludes that the risk 

posed to animals, and to humans from 

contact with animals or consumption of 

animals as food, by farm practices in 

producing and harvesting fruits and 

vegetables does not merit imposition of 

new regulatory requirements at this 

time. Therefore, this proposal is limited 

to produce for use as human food. 

Produce that is intended for use as 

animal food would not be subject to the 

requirements of this rule. This is 

reflected in the title of the proposed rule 

(‘‘Standards for the Growing, 

Harvesting, Packing, and Holding of 

Produce for Human Consumption’’) and 

its proposed location in Chapter I, 

Subchapter B of Title 21, Code of 

Federal Regulations (‘‘Food for Human 

Consumption’’). 

As proposed, § 112.1 establishes the 

scope of food that 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) 

defines ‘‘raw agricultural commodity’’ 

as any food in its raw or natural state, 

including all fruits that are washed, 

colored, or otherwise treated in their 

unpeeled natural form prior to 

marketing.’’ This includes produce 

RACs grown domestically and produce 

RACs that will be imported or offered 

for import in any State or territory of the 

United States, the District of Columbia, 

or the Commonwealth of Puerto Rico. 

As discussed in section III and IV of this 

document, FDA tentatively concludes 

that proposed § 112.1(a) is consistent 

with section 419(a)(1)(A) of the FD&C 

Act, which directs us to establish 

science-based minimum standards for 

the safe production and harvesting of 

those types of fruits and vegetables that 

are raw agricultural commodities for 

which the Secretary has determined that 

such standards minimize the risk of 

serious adverse health consequences or 

death. 

We propose to establish a definition 

of ‘‘produce’’ in proposed § 112.3(c) (see 

section V.A.2.b.iii. of this document) 

that would be relevant to the use of that 

term in proposed § 112.1. ‘‘Produce’’ 

would mean any fruit or vegetable 

(including specific mixes or categories 

of fruits and vegetables) grown for 

human consumption, and would 

include mushrooms, sprouts 

(irrespective of seed source), peanuts, 

tree nuts and herbs. Within the 

definition of ‘‘produce,’’ we would 

further define ‘‘fruit’’ and ‘‘vegetable’’ to 

reflect the common meanings of those 

terms. 

We would define a fruit as the edible 

reproductive body of a seed plant or tree 

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nut (such as apple, orange and almond), 

such that fruit would mean the 

harvestable or harvested part of a plant 

developed from a flower. This is 

consistent with the common meaning of 

the term ‘‘fruit,’’ as demonstrated by the 

Merriam-Webster Dictionary definition 

of ‘‘fruit’’ to mean, in relevant part ‘‘the 

usually edible reproductive body of a 

seed plant; especially: One having a 

sweet pulp associated with the seed 

* * * a succulent plant part (as the 

petioles of a rhubarb plant) used chiefly 

in a dessert or sweet course * * * a 

product of fertilization in a plant with 

its modified envelopes or appendages; 

specifically: The ripened ovary of a seed 

plant and its contents * * *’’ (Ref. 61). 

We would define a vegetable as the 

edible part of an herbaceous plant (such 

as cabbage and potato) or fleshy fruiting 

body of a fungus (such as white button 

and shiitake) grown for an edible part, 

such that vegetable would mean the 

harvestable or harvested part of any 

plant or fungus whose fruit, fleshy 

fruiting bodies, seeds, roots, tubers, 

bulbs, stems, leaves, or flower parts are 

used as food and includes mushrooms, 

sprouts, and herbs (such as basil and 

cilantro). 

This is consistent with the common 

meaning of the term ‘‘vegetable,’’ as 

demonstrated by the Merriam-Webster 

Dictionary definition of ‘‘vegetable’’ to 

mean, in relevant part, ‘‘a usually 

herbaceous plant (as the cabbage, bean, 

or potato) grown for an edible part that 

is usually eaten as part of a meal; also: 

Such an edible part * * *’’ (Ref. 61). 

We are proposing to specify in the 

definition of produce that it includes 

mushrooms, sprouts, peanuts, tree nuts 

and herbs, to leave no doubt about the 

status of these foods. Taxonomically, a 

mushroom is a fungus (Ref. 62). For 

regulatory purposes in the United 

States, however, mushrooms have 

generally been treated as vegetables. 

Mushrooms are classified as vegetables 

by USDA AMS under the Perishable 

Agricultural Commodities Act (7 U.S.C. 

499a–499t) (PACA) (Ref. 63), using a 

definition stating in relevant part that 

‘‘fresh fruits and fresh vegetables’’ 

means ‘‘all produce in fresh form 

generally considered as perishable fruits 

and vegetables * * *’’ (21 CFR 46.2(u)). 

The USDA 2010 Dietary Guidelines for 

Americans also include mushrooms in 

the ‘‘vegetable’’ food group (Ref. 64). In 

addition, the produce industry appears 

to recognize mushrooms as vegetables, 

as demonstrated by various industry 

documents (Ref. 65. Ref. 66). Moreover, 

the hazards and controls relevant to 

minimizing serious adverse health 

consequences or death during the 

growing, harvesting, packing, and 

holding of mushrooms are generally 

similar to those for other produce (Ref. 

67). Accordingly, we tentatively 

conclude that it is reasonable to include 

mushrooms in the proposed definition 

of ‘‘vegetable.’’ 

Sprouts meet the definition of 

‘‘vegetable’’ above from the MerriamWebster Dictionary (Ref. 61). In 

addition, sprouts are classified as 

vegetables by USDA AMS under PACA 

(Ref. 63). The USDA 2010 Dietary 

Guidelines for Americans also include 

‘‘bean sprouts’’ in the ‘‘vegetable’’ food 

group (Ref. 64). In addition, the produce 

industry appears to recognize sprouts as 

vegetables, as demonstrated by various 

industry documents (Ref. 68). Moreover, 

the hazards and controls relevant to 

minimizing serious adverse health 

consequences or death during the 

growing, harvesting, packing, and 

holding of sprouts are generally similar 

to those for other produce, but with 

additional controls necessary due to the 

unique risks presented by sprouts (Ref. 

160. Ref. 161) (see section V.M of this 

document). Accordingly, we tentatively 

conclude that it is reasonable to include 

sprouts in the proposed definition of 

‘‘vegetable.’’ Herbs meet the definition 

of ‘‘vegetable’’ above from the MerriamWebster Dictionary (Ref. 61). Herbs are 

generally consumed in combination 

with other foods (for example, in salads 

or as garnishes) rather than consumed as 

distinct servings, but they nonetheless 

satisfy the dictionary definition of 

‘‘vegetable.’’ In addition, USDA 

considers herbs to be covered 

commodities under PACA, such that 

they are classified as ‘‘herbs’’ but fall 

within the broader category of ‘‘fresh 

fruits and fresh vegetables’’ (Ref. 63). In 

addition, the produce industry appears 

to recognize herbs as vegetables, as 

demonstrated by various industry 

documents (Ref. 66). Moreover, the 

hazards and controls relevant to 

minimizing serious adverse health 

consequences or death during the 

growing, harvesting, packing, and 

holding of herbs are generally similar to 

those for other produce(Ref. 13. Ref. 50). 

Accordingly, we tentatively conclude 

that it is reasonable to include herbs in 

the proposed definition of ‘‘vegetable.’’ 

Peanuts and tree nuts both meet the 

definition of ‘‘fruit’’ above from the 

Merriam-Webster Dictionary (Ref. 61). 

The Merriam-Webster Dictionary 

defines ‘‘peanut,’’ in relevant part, as ‘‘a 

low-branching widely cultivated annual 

herb * * * of the legume family with 

showy yellow flowers having a 

peduncle which elongates and bends 

into the soil where the ovary ripens into 

a pod containing one to three oily edible 

seeds * * *,’’ and ‘‘nut,’’ in relevant 

part, as ‘‘a hard-shelled dry fruit or seed 

with a separable rind or shell and 

interior kernel * * *’’ (Ref. 61). In 

addition, the produce industry appears 

to recognize peanuts and tree nuts as 

produce, as demonstrated by various 

industry documents (Ref. 65. Ref. 66). 

Moreover, the hazards and controls 

relevant to minimizing serious adverse 

health consequences or death during the 

growing, harvesting, packing, and 

holding of peanuts and tree nuts are 

generally similar to those for other 

produce (Ref. 69. Ref. 70). Specifically, 

peanuts and tree nuts share the 

significant hazard of pathogens with 

other covered produce. To a significant 

extent, this hazard is eliminated during 

manufacturing/processing operations, 

such as roasting, by facilities subject to 

section 418 of the FD&C Act, rather than 

through measures taken by farms subject 

to this regulation. However, as 

discussed in section V.A.2.a below, 

peanuts meet our proposed criteria for 

‘‘rarely consumed raw’’ and therefore 

would be exempt from this proposed 

rule. Tree nuts that do not meet the 

criteria for ‘‘rarely consumed raw’’ 

would also be exempt from this 

proposed regulation if you establish and 

keep documentation that demonstrates 

that the recipient of the produce 

performs commercial processing in 

accordance with proposed § 112.2(b)(1). 

For tree nuts that remain subject to the 

proposed rule, the kinds of measures 

necessary to minimize the risk of known 

or reasonably foreseeable biological 

hazards are the same as those in 

subparts A through O of this proposed 

rule (e.g., control of soil amendments, 

agricultural water, worker hygiene). 

Accordingly, we conclude it is 

reasonable to include peanuts and tree 

nuts in the proposed definition of 

produce as a ‘‘fruit.’’ We recognize that 

peanuts and tree nuts are not covered 

commodities under PACA ((Ref. 63. Ref. 

71) and that the USDA 2010 Dietary 

Guidelines for Americans consider nuts 

a ‘‘protein food’’ rather than as part of 

the ‘‘fruits and vegetables’’ group for the 

purpose of providing dietary advice 

(Ref. 72); however, in light of the 

treatment of peanuts and tree nuts as 

produce in common usage and in the 

produce industry, and the commonality 

of on-farm hazards and controls for 

peanuts, tree nuts, and other produce 

(Ref. 70. Ref. 69), we tentatively 

conclude that it is reasonable to include 

peanuts and tree nuts in the proposed 

definition of produce as ‘‘fruits.’’ 

We propose to specify in the 

definition of ‘‘produce’’ that the term 

would not include food grains, meaning 

the small, hard fruits or seeds of arable 

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crops, or the crops bearing these fruits 

or seeds, that are grown and processed 

for use as meal, flour, baked goods, 

cereals and oils rather than for fresh 

consumption (including cereal grains, 

pseudo cereals, oilseeds and other 

plants used in the same fashion). 

Examples of food grains would include 

barley, dent- or flint-corn, sorghum, 

oats, rice, rye, wheat, amaranth, quinoa, 

buckwheat, cotton seed, and soybean. 

Our proposed definition of ‘‘food 

grains’’ is consistent with the common 

meaning of the term ‘‘grain’’ when used 

in the context of food, as demonstrated 

by the Merriam-Webster Dictionary 

definition of ‘‘grain’’ to mean, in 

relevant part, ‘‘a seed or fruit of a cereal 

grass * * * the seeds or fruits of various 

food plants including the cereal grasses 

and in commercial and statutory usage 

other plants (as the soybean) * * * 

plants producing grain * * *’’ (Ref. 61). 

In addition, the industry appears to 

recognize grains as a separate 

commodity group from produce, as 

demonstrated by various industry 

documents regarding ‘‘produce’’ and 

‘‘fruits and vegetables’’ that do not 

include grains (Ref. 65. Ref. 66). Grains 

are not covered commodities under 

PACA (Ref. 63). The USDA 2010 Dietary 

Guidelines for Americans treat grains as 

a separate food group from the ‘‘fruits 

and vegetables’’ food group (Ref. 73). In 

addition, the hazards and controls 

relevant to minimizing serious adverse 

health consequences or death during the 

growing, harvesting, packing, and 

holding of grains are significantly 

different from those relevant to fruits 

and vegetables (Ref. 74). Specifically, 

the hazards of concern in grains are 

primarily chemical hazards such as 

mycotoxins and pesticides, rather than 

biological hazards (which, as discussed 

in section IV.B. of this document, are 

the only hazards we currently propose 

to address in this rule, as they are the 

most significant hazards affecting 

covered produce), because grains are 

milled and/or cooked such that 

pathogens that may be present are 

reduced to a level where they are 

unlikely to present a risk to public 

health for most products. Accordingly, 

we tentatively conclude that it is 

reasonable to exclude grains from the 

definition of ‘‘produce.’’ 

Proposed § 112.1(b)(1) lists specific 

examples of produce covered by this 

rule. Such covered produce would 

include almonds, apples, apricots, 

aprium, asian pear, avocados, babaco, 

bamboo shoots, bananas, Belgian 

endive, blackberries, blueberries, 

broccoli, cabbage, cantaloupe, 

carambola, carrots, cauliflower, celery, 

cherries, citrus (such as clementine, 

grapefruit, lemons, limes, mandarin, 

oranges, tangerines, tangors, and uniq 

fruit), cucumbers, curly endive, garlic, 

grapes, green beans, guava, herbs (such 

as basil, chives, cilantro, mint, oregano, 

and parsley), honeydew, kiwifruit, 

lettuce, mangos, other melons (such as 

canary, crenshaw and persian), 

mushrooms, nectarine, onions, papaya, 

passion fruit, peaches, pears, peas, 

peppers (such as bell and hot), 

pineapple, plums, plumcot, radish, 

raspberries, red currant, scallions, snow 

peas, spinach, sprouts (such as alfalfa 

and mung bean), strawberries, summer 

squash (such as patty pan, yellow and 

zucchini), tomatoes, walnuts, watercress 

and watermelon. 

The list of fruits and vegetables 

provided in proposed § 112.1(b)(1) is 

not an exhaustive list of produce 

covered by this rule. This section is 

intended simply to provide examples of 

produce commonly consumed in the 

United States that would be included 

within the scope of this regulation. The 

absence of a specific fruit or vegetable 

from this list does not indicate that it is 

not covered, except where the specific 

fruit or vegetable is exempted from the 

regulation by § 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. Proposed § 112.1(b)(2) is 

consistent with section 419(a)(1)(A) of 

the FD&C Act, which includes mixes or 

categories of fruits and vegetable RACs 

as part of the rulemaking requirement 

we are implementing through this 

proposed rule. 

As proposed, § 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, 

asparagus, beets, black-eyed peas, bok 

choy, brussels sprouts, chick-peas, 

collard greens, crabapples, cranberries, 

eggplant, figs, ginger root, kale, kidney 

beans, lentils, lima beans, okra, 

parsnips, peanuts, pinto beans, 

plantains, potatoes, pumpkin, rhubarb, 

rutabaga, sugarbeet, sweet corn, sweet 

potatoes, taro, turnips, water chestnuts, 

winter squash (acorn and butternut 

squash), and yams. Because these listed 

fruits and vegetables are almost always 

consumed only after being cooked, 

which is a kill-step that adequately 

reduces the presence of microorganisms 

of public health significance, we 

propose that these listed produce be 

excluded from the requirements of this 

rule. Studies have shown that the 

numbers of microorganisms of public 

health significance (such as Listeria 

monocytogenes, Salmonella, shiga 

toxin-producing E. coli) are significantly 

reduced in produce by a variety of 

relatively moderate heat treatments (Ref. 

75. Ref. 76. Ref. 77. Ref. 78). Therefore, 

we tentatively conclude that the cooking 

that the produce listed in § 112.2(a)(1) 

receive before they are consumed, 

whether commercially or by the 

consumer, would be sufficient to 

minimize the risk of serious adverse 

health consequences or death. 

We note that all produce commodities 

are and will continue to be covered 

under the adulteration provisions and 

other applicable provisions of the 

Federal Food, Drug, and Cosmetic Act 

and applicable implementing 

regulations, irrespective of whether they 

are included within the scope of this 

proposed rule. 

We developed this list in proposed 

§ 112.2(a)(1) of produce that rarely is 

consumed raw by analyzing 

consumption data on selected produce 

commodities using data available from 

the National Health and Nutrition 

Examination Survey (NHANES) and 

other resources (Ref. 79). We looked at 

the percentage of the population 

consuming the produce commodity in 

fresh form as well as the percentage of 

eating occasions on which the produce 

commodity is eaten uncooked (Ref. 79. 

Ref. 80). As explained further in a memo 

to the record, we found that artichokes, 

asparagus, beets, bok choy, brussels 

sprouts, cranberries, eggplant, figs, 

ginger root, lima beans, okra, plantains, 

potatoes, rhubarb, sweet corn, sweet 

potatoes, turnips, and yams are eaten 

uncooked by less than 0.1% of the U.S. 

population and are consumed uncooked 

on less than 0.1% of eating occasions 

(Ref. 79). Other commodities, including 

black-eyed peas, chick-peas, collard 

greens, crabapples, kale, kidney beans, 

lentils, parsnips, peanuts, pinto beans, 

pumpkin, rutabaga, sugarbeet, taro, 

water chestnut, and winter squash 

(which includes both acorn and 

butternut squash) are included in the 

NHANES data set but their categories of 

reported consumption do not include 

‘‘uncooked,’’ indicating that they are not 

consumed uncooked in any measurable 

quantity (Ref. 79). Still other 

commodities on the list, namely, 

arrowhead and arrowroot, are not 

identified in the NHANES data set as 

being eaten in the United States in any 

form, uncooked or otherwise (Ref. 79). 

Other references indicated that those 

commodities are typically consumed 

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3538 Federal Register / Vol. 78, No. 11 / Wednesday, January 16, 2013 / Proposed Rules 

cooked (Ref. 63. Ref. 82). We request 

comment on the proposed criteria used 

for identifying the commodities that are 

rarely consumed raw. Further, we 

request comment on additional 

commodities that should be considered 

for inclusion in the list in 112.2(a)(1). 

As noted above, we analyzed 

consumption data on selected produce 

commodities to generate this list. We 

acknowledge that there may be 

additional commodities that would 

meet these criteria that we did not 

analyze. Also, we anticipate that, in the 

case of some commodities, the 

consumption rates in the United States 

may be too low for the NHANES data 

and other data sources used in our 

analysis to support a conclusion that the 

commodity is rarely consumed raw 

using our proposed criteria. We request 

comment on additional sources of 

information and/or criteria that should 

be applied in such cases. 

We also request comment on the 

inclusion of commodities that our 

analysis indicates are rarely consumed 

raw, but may not be prepared in a 

manner that would kill microbial 

contaminants, should they be present on 

the food. For example, we have 

included asparagus, bok choy, and 

cranberries in the list of commodities 

that will be exempt from the 

requirements of this rule in proposed 

§ 112.2(a)(1) because the NHANES data 

indicated that these commodities are 

consumed uncooked by less than 0.1% 

of the U.S. population and are 

consumed uncooked on less than 0.1% 

of eating occasions (Ref. 79). However, 

we are concerned that the method of 

food preparation that these commodities 

may be subjected (for example, stir 

frying bok choy) to prior to 

consumption may not constitute a killstep that adequately reduces the 

presence of microorganisms of public 

health significance. We request 

comment on our tentative conclusions 

about these commodities and others 

proposed for exclusion in § 112.2(a)(1). 

Second, § 112.2(a)(2) proposes to 

exempt produce that is produced by an 

individual for personal consumption or 

produced for consumption on the farm 

or another farm under the same 

ownership. With respect to the 

exemption for personal consumption, 

section 419(g) of the FD&C Act 

specifically exempts food produced by 

an individual for personal consumption 

from this rulemaking, and proposed 

§ 112.2(a)(2) implements this exclusion. 

With respect to the exclusion for 

produce for consumption on the farm or 

another farm under the same ownership, 

such activities are within the definition 

of farm that we propose here, and would 

therefore be subject to this rule without 

an exemption. To the extent that there 

is any difference between produce ‘‘for 

personal consumption’’ and produce 

‘‘consumed on the farm or another farm 

under the same ownership,’’ FDA 

proposes to exclude produce for either 

type of consumption from this proposed 

rule. 

Third, § 112.2(a)(3) proposes to 

exclude produce that is not a raw 

agricultural commodity from this 

proposed rule. For example, this would 

exclude ‘‘fresh-cut’’ produce, which is 

subject to current part 110 and to 

section 418 of the FD&C Act as 

applicable (Ref. 83). This is consistent 

with section 419(a)(1)(A) of the FD&C 

Act, which directs FDA to ‘‘establish 

science-based minimum standards for 

the safe production and harvesting of 

those types of fruits and vegetables 

* * * that are raw agricultural 

commodities * * *.’’ This is also 

consistent with the application of this 

rule to activities within the farm 

definition. In section V.A.2.b.i of this 

document, we discuss how we 

considered how the activities of farms 

relate to the concept of a RAC and 

tentatively concluded that the farm 

definition and related definitions in this 

proposed rule should be revised based 

on the concept that RACs are the 

essential products of farms. 

Accordingly, the definitions proposed 

here (for the terms farm, mixed-type 

facility, harvesting, manufacturing/ 

processing, packing, and holding) reflect 

the tentative conclusion that activities 

involving RACs that farms traditionally 

do for the purposes of growing their 

own RACs, removing them from the 

growing areas and preparing them for 

use as a food RAC, and for packing, 

holding and transporting them, should 

all be within the definition of ‘‘farm.’’ 

This is the case even if the same 

activities off-farm would be considered 

to be ‘‘manufacturing/processing’’ 

because those activities involve 

‘‘making food from one or more 

ingredients, or synthesizing, preparing, 

treating, modifying or manipulating 

food.’’ This special classification of onfarm activities, however, should only 

apply to RACs because only RACs, not 

processed foods, are the essential 

products of farms. For all of these 

reasons, RACs are a logical and 

appropriate focus for these produce 

safety standards. 

In addition to these three exemptions 

mentioned above, under the conditions 

specified in § 112.2(b), we propose to 

allow covered produce which receives 

commercial processing that adequately 

reduces the presence of microorganisms 

of public health significance to be 

eligible for an exemption from the 

requirements of this part (except for 

subparts A, Q, and O). Examples of 

commercial processing that adequately 

reduces the presence of microorganisms 

of public health significance are 

processing in accordance with the 

requirements of part 113, part 114, or 

part 120; treating with a validated 

process to eliminate spore-forming 

microorganisms (such as processing to 

produce tomato paste or shelf-stable 

tomatoes); and processing such as 

refining or distilling produce into 

products such as sugar, oil, spirits, or 

similar products. As discussed in 

section IV.C. of this document, FDA 

tentatively concludes that such 

commercial processing significantly 

minimizes the risk of serious adverse 

health consequences or death associated 

with biological hazards for such 

produce, such that the produce can be 

considered to be low risk and the 

imposition of the requirements in this 

proposed rule is not warranted. We note 

that such produce is and will continue 

to be covered under the adulteration 

provisions and other applicable 

provisions of the Federal Food, Drug, 

and Cosmetic Act and applicable 

implementing regulations, irrespective 

of whether it is included within the 

scope of this proposed rule. 

As proposed, to qualify for the 

§ 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 

processing in accordance with the 

requirements of proposed subpart O. 

FDA tentatively concludes that such 

records are necessary for the efficient 

enforcement of the FD&C Act. Without 

such records, FDA would have no way 

to assess whether farms are complying 

with the terms of this exemption. In 

addition, proposed § 112.2(b)(3) would 

clarify that the requirements of subparts 

A and Q apply to such produce because 

subpart A includes relevant provisions 

such as the scope of this rule and 

definitions, and Q contains provisions 

relating to compliance and enforcement. 

It is important to note that any of the 

exemptions in proposed § 112.2 are only 

applicable to the produce specified in 

the exemption. In other words, a 

covered farm may not rely on these 

exemptions for all of its covered 

produce simply because a subset of that 

produce is rarely consumed raw; is for 

personal or on-farm consumption; is not 

a RAC; or will receive the requisite 

commercial processing; in those 

instances, only the subset that meets the 

relevant exemption criteria would be 

exempt from this proposed rule. For 

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Federal Register / Vol. 78, No. 11 / Wednesday, January 16, 2013 / Proposed Rules 3539 

example, if you own or operate a farm 

that produces both tomatoes that will be 

processed into tomato paste, and 

tomatoes that will not receive any 

commercial processing to adequately 

reduce pathogens, and you do not 

qualify for any other exemption, you 

would be subject to the rule when you 

grow, harvest, pack or hold those 

tomatoes that will not be processed to 

adequately reduce pathogens. Likewise, 

if you produce both artichokes and 

lettuce, you would be subject to the rule 

when you grow, harvest, pack or hold 

lettuce, but you would not be subject to 

the rule when you grow, harvest, pack, 

or hold artichokes. 

We request comment on proposed 

§§ 112.1 and 112.2, including the 

specific examples of produce that would 

be covered by the rule; the list of 

produce that would not be covered by 

the rule because it is rarely consumed 

raw; and the proposed exemption for 

produce that receives commercial 

processing, including the types of 

processing that should qualify for this 

exemption. 

b. Definitions 

Proposed § 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 the common meanings 

of these terms as well as the definitions 

of the terms in other food 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 interpretations of terms in section 

201 of the FD&C Act will apply to such 

terms when used in part 112. 

i. Definitions of ‘‘Farm,’’ ‘‘Mixed-Type 

Facility,’’ and Related Activities 

We are proposing to establish an 

inter-related series of definitions in this 

proposed rule that, collectively, would 

address several issues related to the 

scope of establishments (namely, 

‘‘farms’’) that would be subject to the 

rule. These inter-related definitions 

include two definitions for types of 

establishments (i.e., ‘‘farm’’ and ‘‘mixedtype facility’’) and five definitions for 

types of activities (i.e., ‘‘harvesting,’’ 

‘‘holding,’’ ‘‘manufacturing/processing,’’ 

‘‘packaging,’’ and ‘‘packing’’) conducted 

on farms and mixed-type facilities. 

These proposed definitions are based 

on definitions already established in our 

regulations (e.g., in § 1.227 in the 

regulations for Registration of Food 

Facilities, established under section 415 

of the FD&C Act; hereinafter the section 

415 registration regulations). However, 

the definitions that we are proposing for 

the purpose of the produce safety rule 

have some differences relative to the 

current definitions established in the 

section 415 registration regulations. In 

the near future, we plan to address how 

we will coordinate the definitions in the 

section 415 registration regulations with 

the definitions we are proposing for the 

purpose of the produce safety proposed 

rule. 

In developing these proposed 

definitions, we considered how the 

activities of farms relate to the statutory 

concepts of ‘‘raw agricultural 

commodity’’ and ‘‘processed food.’’ The 

FD&C Act defines ‘‘raw agricultural 

commodity’’ and ‘‘processed food’’ in 

relation to each other, and identifies 

certain activities that transform a raw 

agricultural commodity (RAC) into a 

processed food and others that do not. 

Section 201(r) of the FD&C Act (21 

U.S.C. 321(r)) defines ‘‘raw agricultural 

commodity’’ to mean ‘‘any food in its 

raw or natural state, including all fruits 

that are washed, colored, or otherwise 

treated in their unpeeled natural form 

prior to marketing.’’ Section 201(gg) of 

the FD&C Act (21 U.S.C. 321(gg)) 

defines ‘‘processed food’’ to mean ‘‘any 

food other than a raw agricultural 

commodity and includes any raw 

agricultural commodity that has been 

subject to processing, such as canning, 

cooking, freezing, dehydration, or 

milling.’’ In addition, section 

201(q)(1)(B)(i)(II) of the FD&C Act 

(which defines pesticide chemicals) 

contains the following language 

regarding activities that do not 

transform a RAC into a processed food: 

‘‘the treatment [with pesticide 

chemicals] is in a manner that does not 

change the status of the food as a raw 

agricultural commodity (including 

treatment through washing, waxing, 

fumigating, and packing such 

commodities in such manner).’’ 

The status of a food as a RAC or 

processed food is relevant for many 

different purposes under the FD&C Act, 

including section 419(a)(1)(A) of the 

FD&C Act, which authorizes FDA to 

establish minimum science-based 

standards applicable to certain fruits 

and vegetables that are RACs. For 

example, under 403(w) of the FD&C Act 

(21 U.S.C. 343(w)), labeling 

requirements related to major food 

allergens apply to processed foods but 

do not apply to RACs. Under sections 

201(q), 403(k), 403(l), and 408 of the 

FD&C Act (21 U.S.C. 321(q), 343(k), 

343(l), and 346a), the status of a food as 

a RAC has an impact on the manner in 

which pesticide chemicals and their 

residues are regulated. FSMA created 

more provisions in the FD&C Act and 

elsewhere that take status as a RAC or 

processed food into account, including 

section 417(f) of the FD&C Act (21 

U.S.C. 350f(f)), establishing notification 

requirements for reportable foods that 

do not apply to fruits and vegetables 

that are RACs; section 418(m) of the 

FD&C Act, which authorizes FDA to 

exempt or modify the requirements for 

compliance under section 418 with 

respect to facilities that are solely 

engaged in the storage of RACs other 

than fruits and vegetables intended for 

further distribution or processing; and 

section 204(d)(6)(D) of FSMA (21 U.S.C. 

2223(d)(6)(D)), which contains special 

provisions for commingled RACs 

applicable to FDA’s authority under 

section 204 of FSMA to establish 

additional recordkeeping requirements 

for high risk foods. 

The term ‘‘raw agricultural 

commodity’’ and similar terms also 

appear in other Federal statutes. While 

these statutes are not implemented or 

enforced by FDA and do not directly 

impact the interpretation of the 

definitions in sections 201(r) and 

201(gg) of the FD&C Act, they do 

provide some suggestions about what 

‘‘raw agricultural commodity’’ and 

related concepts can mean in various 

circumstances. For example, the 

Secretary of Transportation may 

prescribe commercial motor vehicle 

safety standards under 49 U.S.C. 31136, 

but the Motor Carrier Safety 

Improvement Act of 1999 (Pub. L. 106– 

159, title II, Sec. 229, Dec. 9, 1999), as 

added and amended by the Safe, 

Accountable, Flexible, Efficient 

Transportation Equity Act: A Legacy for 

Users (Pub. L. 109–59, title IV, Sec. 

4115, 4130, Aug. 10, 2005), provided an 

exemption from maximum driving or 

on-duty times for drivers transporting 

‘‘agricultural commodities’’ or farm 

supplies within specific areas during 

planting and harvest periods. In that 

circumstance, ‘‘agricultural commodity’’ 

is defined as ‘‘any agricultural 

commodity, non-processed food, feed, 

fiber, or livestock * * * and insects’’ 

(49 U.S.C. 31136 note). Another 

example is 19 U.S.C. 1677(4)(E), which 

provides for certain circumstances in 

which producers or growers of raw 

agricultural products may be considered 

part of the industry producing 

processed foods made from the raw 

agricultural product for the purposes of 

customs duties and tariffs related to 

such processed foods. In that 

circumstance, ‘‘raw agricultural 

product’’ is defined as ‘‘any farm or 

fishery product’’ (19 U.S.C. 1677(4)(E)). 

These statutes are informative in that 

they suggest that the ‘‘raw agricultural 

commodity’’ concept describes and 

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3540 Federal Register / Vol. 78, No. 11 / Wednesday, January 16, 2013 / Proposed Rules 

signifies the products of farms in their 

natural states, or, in other words, that 

which a farm exists to produce on a 

basic level. 

Because the status of a food as a RAC 

or processed food is of great importance 

in defining the jurisdiction of FDA and 

the U.S. Environmental Protection 

Agency (EPA) over antimicrobial 

substances, FDA and EPA have 

developed guidance regarding whether 

or not various activities transform RACs 

into processed foods. FDA and EPA 

jointly issued a legal and policy 

interpretation of the agencies’ 

jurisdiction under the FD&C Act over 

antimicrobial substances used in or on 

food (hereinafter the ‘‘1998 Joint EPA/ 

FDA Policy Interpretation’’) (63 FR 

54532, October 9, 1998). In 1999, FDA 

issued guidance addressing several of 

the issues discussed in the 1998 Joint 

EPA/FDA Policy Interpretation. (See 

Guidance for Industry: Antimicrobial 

Food Additives, July 1999 (hereinafter 

‘‘Antimicrobial Guidance’’) (Ref. 84)). 

Table 1 summarizes activities that cause 

food RACs to become processed foods 

and activities that do not change the 

status of a food RAC, as set out in the 

1998 Joint EPA/FDA Policy 

Interpretation and the Antimicrobial 

Guidance. 

TABLE 1—THE EFFECT OF ACTIVITIES ON RACS THAT ARE FOODS

Activities that change a RAC into a 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 postslaughter, including skinning, eviscerating, and quartering. 

Slicing. 

Activities that alter the general state of the commodity. 

In developing the proposed 

definitions, we also considered the 

definition of ‘‘manufacturing/ 

processing’’ that FDA established in 

§ 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 activities are 

cutting, peeling, trimming, washing, 

waxing, eviscerating, rendering, 

cooking, baking, freezing, cooling, 

pasteurizing, homogenizing, mixing, 

formulating, bottling, milling, grinding, 

extracting juice, distilling, labeling, or 

packaging. The summary in Table 1 

demonstrates that the activities that 

transform a RAC into a processed food 

(and are sometimes therefore referred to 

as ‘‘processing’’ in the context of a 

food’s status as a RAC or processed 

food) are not coextensive with the 

definition of ‘‘manufacturing/ 

processing’’ that FDA established in 

§ 1.227(b)(6) for the purposes of the 

section 415 registration regulations. The 

definition of ‘‘Manufacturing/ 

processing’’ in that regulation includes 

most food-handling activities because it 

is satisfied by any degree of ‘‘making 

food from one or more ingredients, or 

synthesizing, preparing, treating, 

modifying or manipulating food.’’ In 

contrast, transforming a RAC into a 

processed food seems to require meeting 

a threshold of altering the general state 

of the commodity (Ref. 3, section 7 and 

63 FR 54532 at 54541), sometimes 

referred to as transformation of the RAC 

into a new or distinct commodity (61 FR 

2386 at 2388). Because the activities that 

transform a RAC into a processed food 

are not coextensive with the definition 

of ‘‘manufacturing/processing’’ in 

§ 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. Examples of such 

activities include coloring, washing, and 

waxing. 

The current section 415 registration 

regulations demonstrate that some 

activities may be classified differently 

on farms and off farms. For example, 

‘‘washing’’ is an example of 

manufacturing/processing under the 

definition of that term in § 1.227(b)(6). 

However, ‘‘washing’’ produce is 

identified as part of harvesting under 

the farm definition in § 1.227(b)(3), so 

washing on farms is harvesting rather 

than manufacturing/processing under 

the Section 415 registration regulations. 

To date, we have not articulated 

organizing principles explaining these 

differences. 

In this document, we are tentatively 

articulating five organizing principles 

(summarized in Table 2 below) to 

explain the basis for the proposed 

definitions that would classify activities 

on-farm and off-farm for the purpose of 

this proposed rule. In the near future, 

we plan to address how we will 

coordinate the definitions in the section 

415 registration regulations with the 

definitions we are proposing for the 

purpose of this proposed rule. 

First Organizing Principle. The 

statutes we describe above, and 

previous interpretations of the concepts 

of RACs and processed food as set forth 

in the 1998 Joint EPA/FDA Policy 

Interpretation and the Antimicrobial 

Guidance, lead FDA to tentatively 

conclude that the basic purpose of farms 

is to produce RACs and that RACs are 

the essential products of farms. 

Second Organizing Principle. Our 

second organizing principle is that 

activities that involve RACs and that 

farms traditionally do for the purposes 

of growing their own RACs, removing 

them from the growing areas, and 

preparing them for use as a food RAC, 

and for packing, holding and 

transporting them, should all be within 

the definition of ‘‘farm.’’ This is because 

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the basic purpose of farms is to produce 

RACs (principle 1). This is the case even 

if the same activities off-farm would be 

considered to be manufacturing/ 

processing, because those activities 

involve ‘‘making food from one or more 

ingredients, or synthesizing, preparing, 

treating, modifying or manipulating 

food.’’ 

Third Organizing Principle. Activities 

should be classified based in part on 

whether the food operated on is a RAC 

or a processed food, and on whether the 

activity transforms a RAC into a 

processed food. This is because 

principle 2 (i.e., the special 

classification of on-farm activities) 

should only apply to RACs. A farm that 

chooses to transform its RACs into 

processed foods should be considered to 

have chosen to expand its business 

beyond the traditional business of a 

farm. 

Fourth Organizing Principle. Principle 

2 (i.e., the special classification of onfarm activities) should only apply to 

RACs grown or raised on the farm itself 

or on other farms under the same 

ownership because the essential 

purpose of a farm is to produce its own 

RACs, not to handle RACs grown on 

unrelated farms for distribution into 

commerce. (For the purposes of this 

discussion, we refer to RACs grown or 

raised on a farm or another farm under 

the same ownership as a farm’s ‘‘own 

RACs,’’ in contrast to RACs grown on a 

farm under different ownership, which 

we refer to as ‘‘others’ RACs.’’) 

Activities that farms may perform on 

others’ RACs should appropriately be 

classified as manufacturing/processing, 

packing, or holding in the same manner 

as these activities are classified off-farm 

when the RACs are to be distributed 

into commerce. In general, when a farm 

opts to perform activities outside the 

farm definition, the establishment’s 

activities that are within the farm 

definition should be classified as 

manufacturing/processing, packing, or 

holding in the same manner as for a 

farm that does not perform activities 

outside the farm definition, but the 

activities that are outside the farm 

definition should be classified in the 

same manner as for an off-farm food 

establishment. 

Fifth Organizing Principle. 

Manufacturing/processing, packing, or 

holding food— whether RACs or 

processed foods, from any source—for 

consumption on the farm should remain 

within the farm definition because 

otherwise farms could not feed people 

and animals on the farm without being 

considered to have engaged in activities 

outside the farm definition. 

TABLE 2—SUMMARY OF ORGANIZING PRINCIPLES REGARDING CLASSIFICATION OF ACTIVITIES ON-FARM AND OFF-FARM

Number Organizing principle 

1 ...................... The basic purpose of farms is to produce RACs and RACs are the essential products of farms. 

2 ...................... Activities that involve RACs and that farms traditionally do for the purposes of growing their own RACs, removing them from 

the growing areas, and preparing them for use as a food RAC, and for packing, holding and transporting them, should all be 

within the definition of ‘‘farm.’’ 

3 ...................... Activities should be classified based in part on whether the food operated on is a RAC or a processed food, and on whether 

the activity transforms a RAC into a processed food. 

4 ...................... Activities farms may perform on others’ RACs should appropriately be classified as manufacturing/processing, packing, or holding in the same manner as these activities are classified off-farm when the RACs are to be distributed into commerce. 

5 ...................... Manufacturing/processing, packing, or holding food—whether RACs or processed foods, from any source—for consumption on 

the farm should remain within the farm definition. 

We are proposing to include 

definitions for two types of 

establishments (i.e., ‘‘farm’’ and ‘‘mixedtype facility’’) and five types of 

activities (i.e., ‘‘harvesting,’’ ‘‘holding,’’ 

‘‘manufacturing/processing,’’ 

‘‘packaging,’’ and ‘‘packing’’), to reflect 

the organizing principles articulated 

immediately above and to clarify how 

those definitions apply to specific 

activities depending on where the 

activities take place, the food used in 

the activities, where the food comes 

from, and where the food is consumed. 

We discuss these proposed definitions 

in this section because they are interrelated; however, we propose that they 

appear in § 112.3(c) in alphabetical 

order with the other definitions 

discussed in section V.A.2.b.iii of this 

document below. 

We are proposing to define ‘‘farm’’ to 

mean a facility in one general physical 

location devoted to the growing and 

harvesting of crops, the raising of 

animals (including seafood), or both. 

The term ‘‘farm’’ includes: (i) Facilities 

that pack or hold food, provided that all 

food used in such activities is grown, 

raised, or consumed on that farm or 

another farm under the same ownership; 

and (ii) Facilities that manufacture/ 

process food, provided that all food 

used in such activities is consumed on 

that farm or another farm under the 

same ownership. The proposed 

definition of ‘‘farm’’ is based on the 

definition already established in 

§ 1.227(b) in the section 415 registration 

regulations, except that it does not 

include the statement ‘‘Washing, 

trimming of outer leaves of, and cooling 

produce are considered part of 

harvesting.’’ The description of 

harvesting activities is included in a 

separate proposed definition of 

‘‘harvesting’’ and thus would be 

redundant in the proposed definition of 

‘‘farm.’’ 

We are proposing to define ‘‘Mixedtype facility’’ to mean an establishment 

that engages in both activities that are 

exempt from registration under section 

415 of the FD&C Act and activities that 

require the establishment to be 

registered. This term and its definition 

were initially developed in the 

preamble to the proposed rule on food 

facility registration (68 FR 5378 at 5381) 

and in the interim final rule on food 

facility registration (68 FR 58894 at 

58906–7, 58914, 58934–8). The 

proposed definition would also provide, 

as an example of such a facility, a 

definition of a ‘‘farm mixed-type 

facility.’’ A ‘‘farm mixed-type facility’’ 

would be defined as an establishment 

that grows and harvests crops or raises 

animals and may conduct other 

activities within the farm definition, but 

also conducts activities that require the 

establishment to be registered. This 

definition is important to include in this 

rule because the activities of farm 

mixed-type facilities that are within the 

definition of ‘‘farm’’ are potentially 

subject to this rule, as provided in 

proposed § 112.4. FDA would apply this 

proposed rule only to the ‘‘farm’’ 

portion of these establishments’ 

activities, and not to the ‘‘non-farm’’ 

portion of their activities (which would 

be subject to section 418 of the FD&C 

Act and therefore not subject to this 

proposed rule, consistent with section 

419(h) of the FD&C Act). Put another 

way, farms and the ‘‘farm’’ portion of 

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3542 Federal Register / Vol. 78, No. 11 / Wednesday, January 16, 2013 / Proposed Rules 

the activities of farm mixed-type 

facilities would be subject to this 

proposed rule as applicable. For 

simplicity, FDA proposes to reference 

these activities collectively in proposed 

§ 112.4(a) as one aspect of what makes 

an entity a ‘‘covered farm’’ and then to 

refer only to ‘‘covered farms’’ 

throughout the proposed rule. Thus, 

references to ‘‘farms’’ and ‘‘covered 

farms’’ throughout this proposed rule 

should be understood to include the 

portion of a farm mixed-type facility’s 

activities that are within the farm 

definition. 

We are proposing to define the term 

‘‘Harvesting’’ to apply to farms and farm 

mixed-type facilities and be defined as 

activities that are traditionally 

performed by farms for the purpose of 

removing raw agricultural commodities 

from the place they were grown or 

raised and preparing them for use as 

food. Harvesting would be limited to 

activities performed on raw agricultural 

commodities on the farm on which they 

were grown or raised, or another farm 

under the same ownership. Harvesting 

would not include activities that 

transform a raw agricultural commodity, 

as defined in section 201(r) of the FD&C 

Act, into a processed food as defined in 

section 201(gg) of the FD&C Act. 

Gathering, washing, trimming of outer 

leaves of, removing stems and husks 

from, sifting, filtering, threshing, 

shelling, and cooling raw agricultural 

commodities grown on a farm or 

another farm under the same ownership 

would be listed as examples of 

harvesting. This proposed definition 

would include the same examples of 

‘‘harvesting’’ that are currently part of 

the farm definition in § 1.227(b)(3) 

(washing, trimming of outer leaves, and 

cooling) and would add other examples 

to help clarify the scope of the 

definition of harvesting. ‘‘Harvesting’’ is 

a category of activities that is only 

applicable to farms and farm mixed-type 

facilities. Activities that would be 

‘‘harvesting’’ when performed on a farm 

on the farm’s own RACs would be 

classified differently under other 

circumstances, such as at a processing 

facility that is not on a farm, or when 

performed by a farm on others’ RACs. 

For example, at an off-farm facility that 

packs tomatoes, washing the tomatoes 

after they are received would not be 

‘‘harvesting’’ because it is not being 

performed on the farm that produced 

the tomatoes (or another farm under the 

same ownership). Instead, washing 

tomatoes at the off-farm packing facility 

would be ‘‘manufacturing,’’ because it 

involves preparing, treating, modifying, 

or manipulating food. 

We are proposing to define ‘‘Holding’’ 

to mean the storage of food. The 

proposed definition would state that, for 

farms and farm mixed-type facilities, 

holding would also include activities 

traditionally performed by farms for the 

safe or effective storage of RACs grown 

or raised on the same farm or another 

farm under the same ownership, but 

would not include activities that 

transform a RAC, as defined in section 

201(r) of the FD&C Act, into a processed 

food as defined in section 201(gg) of the 

FD&C Act. This would mean that more 

activities than just storage of food would 

be classified as ‘‘holding’’ when a farm 

or farm mixed-type facility performs 

those activities on its own RACs. For 

example, fumigating or otherwise 

treating a farm’s own RACs against pests 

for the purpose of safe and effective 

storage would be ‘‘holding’’ under this 

proposed definition. However, 

fumigating or otherwise treating food 

against pests under other circumstances 

(such as off-farm or by a farm handling 

others’ RACs) would not be ‘‘holding’’ 

food because it is not storage of food, 

which would remain the definition of 

holding applicable to most 

circumstances. 

We are proposing to define 

‘‘Manufacturing/processing’’ to mean 

making food from one or more 

ingredients, or synthesizing, preparing, 

treating, modifying or manipulating 

food, including food crops or 

ingredients. The proposed definition 

would also state that, for farms and farm 

mixed-type facilities, manufacturing/ 

processing would not include activities 

that are part of harvesting, packing, or 

holding. Under this proposed definition, 

the expanded definitions of ‘‘packing’’ 

and ‘‘holding,’’ and the extra category 

‘‘harvesting,’’ would apply to activities 

performed by farms and farm mixedtype facilities on their own RACs. These 

expanded and extra categories would 

not apply off-farm or to foods other than 

a farm’s own RACs or a farm mixed-type 

facility’s own RACs. Thus, some 

activities that would otherwise be 

manufacturing/processing would 

instead be defined as packing, holding, 

or harvesting by virtue of being 

performed by a farm or farm mixed-type 

facility on its own RACs. Accordingly, 

these activities would not be 

manufacturing/processing because they 

would already be classified into the 

expanded definitions of packing or 

holding, or into the extra category of 

harvesting. 

We are proposing to define 

‘‘Packaging’’ to mean (when used as a 

verb) placing food into a container that 

directly contacts the food and that the 

consumer receives. We are proposing to 

use the same definition of ‘‘packaging’’ 

as is currently established in § 1.227. 

We are proposing to define ‘‘Packing’’ 

to mean placing food into a container 

other than packaging the food. The 

proposed definition would also state 

that, for farms and farm mixed-type 

facilities, packing would also include 

activities (which may include 

packaging) traditionally performed by 

farms to prepare RACs grown or raised 

on the same farm or another farm under 

the same ownership for storage and 

transport, but would not include 

activities that transform a RAC, as 

defined in section 201(r) of the FD&C 

Act, into a processed food as defined in 

section 201(gg) of the FD&C Act. This 

would mean that more activities than 

just placing food into a container other 

than packaging would be classified as 

‘‘packing’’ when a farm or farm mixedtype facility performs those activities on 

its own RACs. For example, packaging 

(placing food into a container that 

directly contacts the food and that the 

consumer receives) a farm’s own RACs 

would be ‘‘packing’’ under this 

definition because farms traditionally 

do this to provide greater protection for 

fragile RACs than would be possible if 

the RACs were placed in containers 

other than the consumer container, and 

because this activity does not transform 

a RAC into a processed food. However, 

packaging food under other 

circumstances would not be ‘‘packing’’ 

food because packaging is explicitly 

excluded from the definition of packing 

applicable to most circumstances 

(placing food into a container other than 

packaging). Other examples of activities 

that could be packing when performed 

by a farm or a farm mixed-type facility 

on its own RACs include packaging or 

packing a mix of RACs together (e.g., in 

a bag containing three different colored 

bell peppers, or a box of mixed produce 

for a community sponsored agriculture 

program farm share); coating RACs with 

wax, oil, or resin coatings used for the 

purposes of storage or transport; placing 

stickers on RACs; labeling packages 

containing RACs; sorting, grading, or 

culling RACs; and drying RACs for the 

purpose of storage or transport. 

Table 3 provides examples of how we 

would classify activities conducted offfarm and on-farm (including farm 

mixed-type facilities) using these 

proposed definitions. 

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Federal Register / Vol. 78, No. 11 / Wednesday, January 16, 2013 / Proposed Rules 3543 

TABLE 3—CLASSIFICATION OF ACTIVITIES CONDUCTED OFF-FARM AND ON-FARM

[including farm mixed-type facilities] 

Classification Off farm On farm (including farm mixed-type facilities) 

Harvesting ............................ 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. 

Examples: Not applicable .............................................. Examples: activities that fit this definition when performed on a farm’s ‘‘own RACs’’ (a term we use to 

include RACs grown or raised on that farm or another farm under the same ownership) include gathering, washing, trimming of outer leaves, removing 

stems and husks, sifting, filtering, threshing, shelling, 

and cooling. These activities, performed on a farm’s 

own RACs, are inside the farm definition. 

Packing ................................ Notes: Placing food in a 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. 

.

Examples: putting individual unit cartons into a larger 

box used for shipping, and putting articles of produce 

in non-consumer containers (such as shipping crates).

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, stickering/labeling, drying for the purpose of storage or transport, and sorting/grading/culling. These activities, performed on a 

farm’s own RACs, are inside the farm definition. 

Activities that fit the definition of packing when performed on a farm on any other foods, including RACs 

grown or raised on a farm not under the same ownership, include putting individual unit cartons into a 

larger box used for shipping, and putting articles of 

produce in non-consumer containers (such as shipping crates)—the same activities that fit the definition 

of packing off farm. These activities, performed on 

food other than a farm’s own RACs, are outside the 

farm definition unless done on food for consumption 

on the farm. 

Holding ................................. Notes: Storage of food ................................................... Notes: Storage of food, or activities traditionally performed by farms for the safe or effective storage of 

RACs grown or raised on that farm or another farm 

under the same ownership. Holding does not include 

activities that change a RAC into a processed food. 

Activities that are holding are within the farm definition when they are performed on food grown, raised, 

or consumed on that farm or another farm under the 

same ownership; under any other circumstances they 

are outside the farm definition. 

Example: storing food, such as 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. 

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3544 Federal Register / Vol. 78, No. 11 / Wednesday, January 16, 2013 / Proposed Rules 

TABLE 3—CLASSIFICATION OF ACTIVITIES CONDUCTED OFF-FARM AND ON-FARM—Continued 

[including farm mixed-type facilities] 

Classification Off farm On farm (including farm mixed-type facilities) 

An activity that fit the definition of holding when performed on a farm on any other foods, including RACs 

grown or raised on a farm not under the same ownership, is storing food, such as in a warehouse—the 

same activity that fits the definition of holding off 

farm. This activity, performed on food other than a 

farm’s own RACs, is outside the farm definition unless done on food for consumption on the farm. 

Manufacturing/Processing .... Notes: Making food from 1 or 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. 

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 postslaughter operations, irradiation, cutting/coring/chopping/slicing, canning, artificial ripening, cooking, pasteurizing/homogenizing, infusing, distilling, salting, 

smoking, grinding/milling, and freezing.

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, grinding/milling, and freezing. These activities, performed on a farm’s own 

RACs, are 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, packaging, mixing, coating, stickering/labeling, drying, sorting/grading/culling not incidental to packing or holding, fumigating, slaughtering animals or post-slaughter operations, irradiation, cutting/coring/chopping/slicing, 

canning, artificial ripening, cooking, pasteurizing/homogenizing, infusing, distilling, salting, smoking, 

grinding/milling, and freezing—the same activities 

that fit the definition of manufacturing/processing off 

farm. These activities, performed on food other than 

a farm’s own RACs, are outside the farm definition 

unless done on food for consumption on the farm. 

ii. Proposed Definitions of ‘‘Very Small 

Business’’ and ‘‘Small Business’’ 

SUMMARY OF PROPOSED QUALIFICATIONS

[on a rolling basis, average annual monetary value of food sold during the previous three-year period] 

Above $250,000 and no more than $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 business’’ for purposes of 

this proposed rule only. FDA uses a 

measure of the average annual monetary 

value of food sold to determine farm 

size. This measure should serve as a 

valid proxy for both the volume and 

value of production within size category 

and commodities. The USDA National 

Commission on Small Farms 

recommended a definition for a small 

farm as a family farm with less than 

$250,000 annual monetary value of all 

commodities sold (Ref. 85). The 

Commission’s recommendation was 

based on the reasoning that these farms 

are the likeliest to exit the industry, and 

have the greatest need to improve net 

farm incomes Ref. 85). The Commission 

states that although 94% of all U.S. 

farms generate less than $250,000 

annual monetary value of all 

commodities sold, their revenue 

constitutes only 41% of total gross 

revenue from all farms (Ref. 85). We 

propose to use the $250,000 annual 

monetary value of food sold threshold 

for our cutoff of a very small farm since 

the revenue of covered produce farms 

below this threshold constitutes only 

12% of total gross revenue from food 

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Federal Register / Vol. 78, No. 11 / Wednesday, January 16, 2013 / Proposed Rules 3545 

sales by produce farms and make up 

83% of all produce farms. We propose 

to use the statutory cutoff of $500,000 

annual monetary value of food sold as 

one part of the criteria for the qualified 

exemption in section 419(f) of the FD&C 

Act (implemented in proposed § 112.5) 

as the threshold for a small farm. Farms 

below the $500,000 annual value of food 

sold cutoff make up 89% of covered 

farms, and their revenue constitutes 

18% of total gross revenue from food 

sales by produce farms. We developed 

this proposed definition using sales 

class breaks found in generally available 

information from USDA (Ref. 86). 

Proposed § 112.3(b)(1) would define 

your farm to be a very small business if 

it is subject to proposed part 112 and, 

on a rolling basis, the average annual 

monetary value of food you sold during 

the previous three-year period is no 

more than $250,000. 

Proposed § 112.3(b)(2) would define 

your farm to be a small business if it is 

subject to proposed part 112 and, on a 

rolling basis, the average annual 

monetary value of food you sold during 

the previous three-year period is no 

more than $500,000; and your farm is 

not a very small business as provided in 

proposed § 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 subject 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 

classified as small or very small 

businesses. 

iii. Additional Proposed Definitions 

Proposed § 112.3(c) would establish 

the following additional definitions that 

would apply for the purposes of part 

112. 

We propose to define ‘‘adequate’’ to 

mean that which is needed to 

accomplish the intended purpose in 

keeping with good public health 

practice. This proposed definition is the 

same as the definition we have 

established in § 110.3 with respect to 

current good manufacturing practice in 

manufacturing, packing, or holding 

human food. We have been applying 

this definition for the purpose of 

enforcing the regulations in part 110 for 

more than 40 years and tentatively 

conclude that it would be an 

appropriate definition to apply to part 

112 as well. Throughout this document, 

we provide examples of what we mean 

by ‘‘adequate’’ for purposes of 

complying with specific proposed 

provisions. 

We propose to define ‘‘adequately 

reduce microorganisms of public health 

significance’’ to mean reduce the 

presence of such microorganisms to an 

extent sufficient to prevent illness. This 

proposed definition would establish in 

part 112 a definition that we have used 

in guidance associated with the risk of 

foodborne illness from pathogens (Ref. 

87. Ref. 88). As discussed in those 

documents, the extent of reduction 

sufficient to prevent illness is usually 

determined by the estimated extent to 

which a pathogen may be present in the 

food combined with a safety factor to 

account for uncertainty in that estimate. 

For example, if it is estimated that there 

would be no more than 1,000 (i.e., 3 

logs) Salmonella organisms per gram of 

food, and a safety factor of 100 (i.e., 2 

logs) is employed, a process that 

adequately reduces Salmonella spp. 

would be a process capable of reducing 

Salmonella spp. by 5 logs per gram of 

food. 

We propose to define ‘‘agricultural 

tea’’ to mean a water extract of 

biological materials (such as humus, 

manure, non-fecal animal byproducts, 

peat moss, pre-consumer vegetative 

waste, table waste, or yard trimmings), 

excluding any form of human waste, 

produced to transfer microbial biomass, 

fine particulate organic matter, and 

soluble chemical components into an 

aqueous phase. Agricultural teas are 

held for longer than one hour before 

application. We developed this term to 

cover a wide range of ‘‘teas’’ used in 

production of fresh produce, but not to 

include ‘‘tea’’ served as a beverage. The 

term ‘‘agricultural tea’’ was based in 

part on the definition of ‘‘compost tea’’ 

developed by the National Organic 

Standards Board (Ref. 89). Human waste 

would be excluded for consistency with 

proposed § 112.53 regarding the use of 

human waste as a soil amendment. The 

one hour limitation is intended to 

distinguish between agricultural teas 

and other liquids such as leachate and 

runoff and is consistent with the 

recommendations of the 

recommendations of the National 

Organic Standards Board (Ref. 36). 

We propose to define ‘‘agricultural tea 

additive’’ to mean a nutrient source 

(such as molasses, yeast extract, or algal 

powder) added to agricultural tea to 

increase microbial biomass. The term 

‘‘agricultural tea additive’’ was based in 

part on the definition of ‘‘compost tea 

additive’’ developed by the National 

Organic Standards Board (Ref. 89). 

We propose to define ‘‘agricultural 

water’’ to mean water used in covered 

activities on covered produce where 

water is intended to, or is likely to, 

contact covered produce or food-contact 

surfaces, including water used in 

growing activities (including irrigation 

water applied using direct water 

application methods, water used for 

preparing crop sprays, and water used 

for growing sprouts) and in harvesting, 

packing, and holding activities 

(including water used for washing or 

cooling harvested produce and water 

used for preventing dehydration of 

covered produce). This proposed 

definition is different from our 

definition of agricultural water in our 

Good Agricultural Practices guide (Ref. 

10) both because it is not limited to 

water in the growing environment, and 

because we have excluded water that 

does not contact covered produce from 

this definition based on the information 

in our QAR. 

We propose to define ‘‘animal 

excreta’’ to mean solid or liquid animal 

waste. By contrast, we are proposing to 

define ‘‘manure’’ to mean animal 

excreta, alone or in combination with 

litter (such as straw and feathers used 

for animal bedding) for use as a soil 

amendment. We are proposing 

definitions to distinguish ‘‘animal 

excreta’’ from ‘‘manure’’ based on 

whether the animal excreta is used as a 

soil amendment because some proposed 

requirements make such a distinction. 

For example, the proposed requirements 

in §§ 112.54 and 112.56 are directed to 

the treatment and safe application of 

biological soil amendments of animal 

origin, including manure intentionally 

used as a soil amendment, and the 

proposed requirements in §§ 112.82 and 

112.83 would be directed to preventing 

contamination of covered produce with 

animal excreta deposited by wild or 

domestic animals that intrude in an area 

where a covered activity is conducted 

on covered produce. The proposed 

definition of ‘‘manure’’ also accounts for 

the potential inclusion of animal litter 

that is collected with animal excreta, 

e.g., from barns. 

We propose to define ‘‘application 

interval’’ to mean the time interval 

between application of an agricultural 

input (such as a biological soil 

amendment of animal origin) to a 

growing area and harvest of covered 

produce from the growing area where 

the agricultural input was applied. The 

proposed definition would provide a 

simple term to use when describing 

such a time interval. The proposed 

application intervals for biological soil 

amendments in proposed § 112.56 

would establish requirements regarding 

such time intervals. 

We propose to define ‘‘biological soil 

amendment’’ to mean any soil 

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3546 Federal Register / Vol. 78, No. 11 / Wednesday, January 16, 2013 / Proposed Rules 

amendment containing biological 

materials such as humus, manure, nonfecal animal byproducts, peat moss, preconsumer vegetative waste, sewage 

sludge biosolids, table waste, 

agricultural tea, or yard trimmings, 

alone or in combination. We are 

proposing this definition as a means to 

distinguish soil amendments that 

contain biological components from 

those that do not (like chemical 

fertilizers). In addition, we propose to 

define ‘‘biological soil amendment of 

animal origin’’ to mean a biological soil 

amendment which consists, in whole or 

in part, of materials of animal origin, 

such as manure or non-fecal animal 

byproducts, or table waste, alone or in 

combination. The term ‘‘biological soil 

amendment of animal origin’’ does not 

include any form of human waste. We 

are proposing this definition as a means 

to distinguish these biological soil 

amendments from soil amendments that 

are wholly plant-based (such as yard 

trimmings). 

We propose to define ‘‘composting’’ to 

mean a process to produce humus in 

which organic material is decomposed 

by the actions of microorganisms under 

thermophilic conditions for a 

designated period of time (for example, 

3 days) at a designated temperature (for 

example, 131 °F (55 °C)), followed by a 

curing stage under cooler conditions. 

The proposed definition is consistent 

with definitions or explanations of 

‘‘compost’’ and ‘‘composting’’ in 

documents such as a State regulation 

(Ref. 90), Appendix B to 40 CFR part 

503 (Ref. 91), documents prepared by 

the U.S. EPA (Ref. 92), and the Produce 

Safety Project Issue Brief on Composting 

of Animal Manures (Ref. 27). 

We propose to define ‘‘covered 

activity’’ to mean growing, harvesting, 

packing, or holding covered produce, 

provided that all covered produce used 

in covered packing or holding activities 

is grown, raised, or consumed on that 

farm or another farm under the same 

ownership. Covered activities would not 

include manufacturing/processing 

within the definition elsewhere in 

proposed § 112.3(c). As discussed in 

sections III.F and V.A.2.b.i of this 

document, manufacturing/processing on 

a farm is potentially subject to the 

coverage of Section 418 of the FD&C 

Act, unless all of the food used in such 

activities is consumed on that farm or 

another farm under the same ownership. 

Where all of the manufactured/ 

processed food is consumed on that 

farm or another farm under the same 

ownership, the activity would be 

potentially within the scope of Section 

419 of the FD&C Act and this proposed 

rule, except that Section 419(g) of the 

FD&C Act specifies that ‘‘[t]his section 

shall not apply to produce that is 

produced by an individual for personal 

consumption,’’ and section 419(c)(1)(B) 

of the FD&C Act also requires that FDA 

ensure that the final rule is practicable 

for ‘‘a small food processing facility colocated on a farm.’’ 

FDA tentatively concludes that onfarm manufacturing/processing 

activities for on-farm consumption (like 

produce for individual consumption) 

should not be subject to this rule, either 

because it is automatically excluded by 

Section 419(g) or because, to the extent 

there may be any difference between 

produce ‘‘for personal consumption’’ 

and produce ‘‘consumed on the farm or 

another farm under the same 

ownership,’’ it is appropriate to exclude 

on-farm manufacturing/processing for 

on-farm consumption from the rule. The 

definition of covered activity would also 

specify, for clarity, that this part does 

not apply to activities of a facility that 

are subject to part 110 of this chapter . 

We propose to define ‘‘covered 

produce’’ to mean produce that is 

subject to the requirements of this part 

in accordance with §§ 112.1 and 112.2. 

The term ‘‘covered produce’’ refers to 

the harvestable or harvested part of the 

crop. We are proposing to define 

‘‘covered produce’’ to provide a simple 

term to use when describing food that 

would be within the scope of the rule 

under proposed § 112.1 and not exempt 

from the rule under proposed § 112.2. 

We propose to define ‘‘curing’’ to 

mean the maturation stage of 

composting, which is conducted after 

much of the readily metabolized 

biological material has been 

decomposed, at cooler temperatures 

than those in the thermophilic phase of 

composting, to further reduce 

pathogens, promote further 

decomposition of cellulose and lignin, 

and stabilize composition. This 

proposed definition is consistent with 

definitions of ‘‘curing’’ in a State 

regulation (Ref. 93), documents 

prepared by the U.S. EPA (Ref. 92), and 

a glossary of composting terms prepared 

by the Cornell Waste Management 

Institute (Ref. 94). 

We propose to define ‘‘direct water 

application method’’ to mean using 

agricultural water in a manner whereby 

the water is intended to, or is likely to, 

contact covered produce or food-contact 

surfaces during use of the water. This 

proposed definition would provide a 

simple term to use when describing 

such water within regulations such as 

proposed § 112.44(c). By cross-reference 

to the definitions of ‘‘covered produce’’ 

and ‘‘produce’’, this term only applies to 

methods in which the water is intended 

to, or is likely to, contact the harvestable 

part of the covered produce. 

We propose to define ‘‘food’’ to mean 

food as defined in section 201(f) of the 

FD&C Act and to include seeds and 

beans used to grow sprouts. We have 

long considered seeds and beans used to 

grow sprouts to be ‘‘food’’ within the 

meaning of section 201(f) of the FD&C 

Act (Ref. 95). Seeds and beans used to 

grow sprouts are both articles used for 

food and articles used for components 

of articles used for food. We are 

proposing to include them specifically 

in the definition of food for purposes of 

this rule for clarity because sprouts are 

covered by this rule. 

We propose to define ‘‘food-contact 

surfaces’’ to mean those surfaces that 

contact human food and those surfaces 

from which drainage or other transfer 

onto the food or onto surfaces that 

contact the food ordinarily occurs 

during the normal course of operations. 

‘‘Food-contact surfaces’’ includes foodcontact surfaces of equipment and tools 

used during harvest, packing, and 

holding. This proposed definition of 

‘‘food-contact surfaces’’ is consistent 

with the definition of this term in 

§ 110.3 except that we propose to add 

the phrase ‘‘or other transfer’’ after 

‘‘drainage’’ definition of ‘‘food-contact 

surfaces’’ to clarify that surfaces from 

which any transfer involving liquids or 

non-liquids onto the food or onto 

surfaces that contact the food are foodcontact surfaces. 

We propose to define ‘‘hazard’’ to 

mean any biological agent that is 

reasonably likely to cause illness or 

injury in the absence of its control. The 

proposed definition is consistent with 

the NACMCF HACCP guidelines, the 

Codex HACCP Annex, Federal HACCP 

regulations for seafood, juice, and meat 

and poultry, except that for the 

purposes of this rule the term would be 

limited to biological hazards because, as 

discussed in section IV.A. of this 

document, this proposed rule is only 

addressing biological hazards. The 

NACMCF HACCP guidelines (Ref. 41) 

and our HACCP regulation for juice 

(§ 120.3(g)) define ‘‘hazard’’ and ‘‘food 

hazard,’’ respectively as a biological, 

chemical, or physical agent that is 

reasonably likely to cause illness or 

injury in the absence of its control. The 

Codex HACCP Annex defines ‘‘hazard’’ 

as a biological, chemical or physical 

agent in, or condition of, food with the 

potential to cause an adverse health 

effect (Ref. 96). Our HACCP regulation 

for seafood (§ 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 

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to be unsafe for human consumption. 

We recognize that there are other 

hazards relevant to produce safety on 

farm that would not be addressed in this 

proposed rule such as chemical, 

physical, and radiological hazards (see 

section IV.B. of this document) and do 

not intend to suggest by this definition 

that such hazards are not hazards. We 

request comment on whether we should 

instead use the term ‘‘biological 

hazards’’ in this rule. 

We propose to define ‘‘humus’’ to 

mean a stabilized (i.e., finished) 

biological soil amendment produced 

through a controlled composting 

process. We are proposing to use 

‘‘humus’’ as the term to identify the 

final, mature product of composting for 

the purpose of this rule. Our proposed 

definition derives from our proposed 

definitions for ‘‘composting’’ and 

‘‘curing’’ and the Cornell Waste 

Management Institute’s glossary of 

composting terms (Ref. 94), which 

defines humus as a complex aggregate 

made during the decomposition of plant 

and animal residues; mainly derivatives 

of lignin, proteins, and cellulose 

combined with inorganic soil parts. 

However, other relevant documents 

(Ref. 27. Ref. 92. Ref. 97) refer to the 

production of ‘‘humus-like material’’ 

through composting, and humus can be 

produced by mechanisms other than the 

action of microorganisms (Ref. 98). We 

request comment on whether our 

proposed definition and use of the term 

‘‘humus’’ for the final product of 

composting is appropriate for the 

purpose of this rule, or whether we 

should use a term other than ‘‘humus,’’ 

such as ‘‘mature compost.’’ 

We propose to define ‘‘manure’’ to 

mean animal excreta, alone or in 

combination with litter (such as straw 

and feathers used for animal bedding) 

for use as a soil amendment. As 

discussed above in the definition of 

animal excreta, this definition is 

intended to make a distinction between 

the terms ‘‘manure’’ and ‘‘animal 

excreta.’’ 

We propose to define 

‘‘microorganisms’’ to mean yeasts, 

molds, bacteria, viruses, protozoa, and 

microscopic parasites and to include 

species having public health 

significance. As proposed, the term 

‘‘undesirable microorganisms’’ includes 

those microorganisms that are of public 

health significance, that subject food to 

decomposition, that indicate that food is 

contaminated with filth, or that 

otherwise may cause food to be 

adulterated. The substantive difference 

between this proposed definition and 

that in current § 110.3 is the addition of 

protozoa (e.g., Giardia lamblia) and 

microscopic parasites (e.g., Cyclospora 

cayetanensis). Because such 

microorganisms are relevant to produce 

safety, we tentatively conclude that it is 

reasonable to include them. 

We propose to define ‘‘monitor’’ to 

mean to conduct a planned sequence of 

observations or measurements to assess 

whether a process, point, or procedure 

is under control, and, when applicable, 

to produce an accurate record of the 

observation or measurement. 

We propose to define ‘‘non-fecal 

animal byproduct’’ to mean solid waste 

(other than manure) that is animal in 

origin (such as meat, fat, dairy products, 

eggs, carcasses, blood meal, bone meal, 

fish meal, shellfish waste (such as crab, 

shrimp, and lobster waste), fish 

emulsions, and offal) and is generated 

by commercial, institutional, or 

agricultural operations. This proposed 

definition reflects the use of a similar 

term in sources such as the State of 

Florida’s regulations (Ref. 90). However, 

we are proposing to include more 

examples of these byproducts than are 

included in Florida’s regulations to 

clearly communicate what we mean by 

the term. We propose to define ‘‘pest’’ 

to mean any objectionable animals or 

insects including birds, rodents, flies, 

and larvae. This proposed definition is 

consistent with the definition of ‘‘pest’’ 

in current § 110.3. 

We propose to define ‘‘pre-consumer 

vegetative waste’’ to mean solid waste 

that is purely vegetative in origin, not 

considered yard trash, and derived from 

commercial, institutional, or 

agricultural operations without coming 

in contact with animal products, 

byproducts or manure or with an end 

user (consumer). As proposed, preconsumer vegetative waste includes 

material generated by farms, packing 

houses, canning operations, wholesale 

distribution centers and grocery stores; 

products that have been removed from 

their packaging (such as out-of-date 

juice, vegetables, condiments, and 

bread); and associated packaging that is 

vegetative in origin (such as paper or 

corn-starch based products). As 

proposed, pre-consumer vegetative 

waste does not include table waste, 

packaging that has come in contact with 

materials (such as meat) that are not 

vegetative in origin, or any waste 

generated by restaurants. This proposed 

definition is consistent with a State 

regulation (Ref. 90). 

For the purpose of this rule, we 

propose to define the term ‘‘produce’’ to 

mean any fruit or vegetable (including 

mixes of intact fruits and vegetables) 

and includes mushrooms, sprouts 

(irrespective of seed source), peanuts, 

tree nuts and herbs. For the purposes of 

this rule, we propose to define ‘‘fruit’’ 

as the edible reproductive body of a 

seed plant or tree nut (such as apple, 

orange and almond) such that fruit 

means the harvestable or harvested part 

of a plant developed from a flower; and 

‘‘vegetable’’ as the edible part of an 

herbaceous plant (such as cabbage or 

potato) or fleshy fruiting body of a 

fungus (such as white button or 

shiitake) grown for an edible part such 

that vegetable means the harvestable or 

harvested part of any plant or fungus 

whose fruit, fleshy fruiting bodies, 

seeds, roots, tubers, bulbs, stems, leaves, 

or flower parts are used as food and 

includes mushrooms, sprouts, and herbs 

(such as basil or cilantro). 

For the purposes of this rule, produce 

does not include ‘‘food grains’’ meaning 

the small, hard fruits or seeds of arable 

crops, or the crops bearing these fruits 

or seeds, that are grown and processed 

for use as meal, flour, baked goods, 

cereals and oils rather than for fresh 

consumption (including cereal grains, 

pseudo cereals, oilseeds and other 

plants used in the same fashion). 

Examples of food grains include barley, 

dent- or flint-corn, sorghum, oats, rice, 

rye, wheat, amaranth, quinoa, 

buckwheat, cotton seed, and soybeans. 

With this definition, we are proposing 

to specifically include mushrooms, 

sprouts (irrespective of seed source), 

peanuts, tree nuts and herbs, and 

specifically exclude food grains. We 

explain our proposed definition of 

‘‘produce’’ in detail above, in section 

V.A.2.a of this document. We request 

comments on our proposed definition of 

‘‘produce.’’ 

We propose to define ‘‘production 

batch of sprouts’’ to mean all sprouts 

that are started at the same time in a 

single growing unit (e.g., a single drum 

or bin, or a single rack of trays that are 

connected to each other), whether or not 

the sprouts are grown from a single lot 

of seed (including, for example, when 

multiple types of seeds are grown 

within a single growing unit). Through 

this definition, we intend to treat as a 

production batch product that would be 

exposed to the same conditions during 

sprouting, such as multiple seed types 

grown in a common drum or multiple 

trays in a single rack that may be 

exposed to water that has contacted 

other product in the same growing unit. 

This term is used in proposed subpart 

M. Limiting the definition of 

‘‘production lot’’ to a single growing 

unit would prevent sprout growers from 

‘‘pooling’’ samples from multiple 

growing units within an operation 

whereby contamination in spent water 

in one unit could be diluted by noncontaminated water from other units to 

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the point where pathogens might not be 

detected. This proposed definition is 

consistent with our 1999 guidance for 

industry on sampling and microbial 

testing of spent irrigation water during 

sprout production (Ref. 15). We 

recognize that there are a diversity of 

growing practices and a variety of 

growing units that may represent 

different product volumes, so we 

request comment on this proposed 

definition. 

We propose to define ‘‘qualified enduser,’’ 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 produced the food; or (ii) not more 

than 275 miles from such farm. The 

definition would also state that the term 

‘‘consumer’’ does not include a 

business. This definition implements 

section 419(f)(4) of the FD&C Act. We 

note that section 419(f)(4)(A) of the 

FD&C Act does not provide for a 

different analysis for when an 

international border falls within the 275 

miles; thus, we tentatively conclude that 

international borders should not affect 

the distance calculation. Thus, for 

example, a farm in Mexico selling food 

to a restaurant or retail food 

establishment in the U.S. that is within 

275 miles of the farm could count that 

sale as a sale to a qualified end user. As 

another example, the same would also 

be true for a U.S. farm selling food to a 

restaurant or retail food establishment 

in Mexico that is within 275 miles of the 

farm. Finally, we also note that the 

requirements related to distance (in the 

same state or within 275 miles of the 

farm) only apply to restaurants and 

retail food establishment customers, and 

not to consumers. Thus, a farm may 

count any sale directly to a consumer as 

a sale to a qualified end-user. 

We propose to define ‘‘raw 

agricultural commodity (RAC)’’ to mean 

‘‘raw agricultural commodity’’ as 

defined in section 201(r) of the FD&C 

Act. We propose to include this 

reference to the FD&C Act definition to 

provide additional clarity regarding the 

meaning of this term. 

We propose to define ‘‘reasonably 

foreseeable hazard’’ to mean a potential 

hazard that may be associated with the 

farm or the food. We provide a proposed 

definition for this term as it is used in 

section 419(c)(1)(A) of the FD&C Act 

and reflected in several requirements 

proposed in this rule. As noted in the 

discussion of the proposed definition of 

‘‘hazard’’ in this section, this definition 

would be limited to biological hazards 

because those are the only hazards we 

are currently proposing to address in 

this rule. We recognize that there are 

other reasonably foreseeable hazards 

relevant to produce safety on farm that 

would not be addressed in this 

proposed rule such as chemical, 

physical, and radiological hazards (see 

section IV.B of this document) and do 

not intend to suggest by this definition 

that such hazards are not reasonably 

foreseeable. We request comment on 

whether we should instead use the term 

‘‘reasonably foreseeable biological 

hazards’’ in this rule. 

We propose to define ‘‘sanitize’’ to 

mean to adequately treat cleaned foodcontact surfaces by a process that is 

effective in destroying vegetative cells of 

microorganisms of public health 

significance, and in substantially 

reducing numbers of other undesirable 

microorganisms, but without adversely 

affecting the product or its safety for the 

consumer. This proposed definition is 

consistent with the existing § 110.3 

definition for ‘‘sanitize’’ except that we 

propose to include the term ‘‘cleaned’’ 

before ‘‘food-contact surfaces.’’ It is well 

established that sanitizers can be 

inactivated by organic material and, 

thus, are not effective unless used on 

clean surfaces (Ref. 99). This proposed 

definition is consistent with the 

definition of ‘‘sanitize’’ in § 111.3. 

We propose to define ‘‘sewage sludge 

biosolids’’ to mean the solid or semisolid residue generated during the 

treatment of domestic sewage in a 

treatment works within the meaning of 

the definition of ‘sewage sludge’ in 40 

CFR 503.9(w). This proposed definition 

is consistent with that of the U.S. 

Environmental Protection Agency 

(EPA), which has regulatory jurisdiction 

over treated domestic sewage and has 

established terms to describe specific 

types of treated waste. 

We propose to define ‘‘soil 

amendment’’ to mean any chemical, 

biological, or physical material (such as 

elemental fertilizers, humus, manure, 

non-fecal animal byproducts, peat moss, 

perlite, pre-consumer vegetative waste, 

sewage sludge biosolids, table waste, 

agricultural tea and yard trimmings) 

intentionally added to the soil to 

improve the chemical or physical 

condition of soil in relation to plant 

growth or to improve the capacity of the 

soil to hold water. This proposed 

definition is consistent with commonly 

used definitions in industry guidelines 

and marketing agreements (Ref. 46. Ref. 

31). We also propose to include within 

the meaning of ‘‘soil amendment’’ 

growth media that serve as the entire 

substrate during the growth of covered 

produce (such as mushrooms and some 

sprouts). While this inclusion is not 

consistent with the common usage of 

the term, it provides convenience since 

it is addressing the identical standards 

that we are proposing for identical 

hazards that exist for such growth media 

and soil amendments. 

We propose to define ‘‘spent sprout 

irrigation water’’ to mean water that has 

been used in the growing of sprouts. 

This definition is intended to minimize 

the potential for confusion between 

spent sprout irrigation water and water 

used for irrigation of other types of 

covered produce.We are proposing to 

define ‘‘static composting’’ to mean a 

process to produce humus in which air 

is introduced into biological material (in 

a pile (or row) covered with at least 6 

inches of insulating material, or in an 

enclosed vessel) by a mechanism that 

does not include turning. As proposed, 

examples of structural features for 

introducing air would include 

embedded perforated pipes and a 

constructed permanent base that 

includes aeration slots. As proposed, 

examples of mechanisms for 

introducing air include passive 

diffusion and mechanical means (such 

as blowers that suction air from the 

composting material or blow air into the 

composting material using positive 

pressure). The proposed definition 

derives from definitions and 

explanations of ‘‘static composting’’ in 

documents such as prepared by the U.S. 

EPA (Ref. 92), the Produce Safety 

Project Issue Brief on Composting of 

Animal Manures (Ref. 27), and a report 

from the Food and Agriculture 

Organization of the United Nations (Ref. 

100). 

We propose to define ‘‘surface water’’ 

to mean all water which is open to the 

atmosphere and subject to surface 

runoff, including water obtained from 

an underground aquifer that is held or 

conveyed in a manner that is open to 

the atmosphere, such as in canals, 

ponds, other surface containment or 

open conveyances. This proposed 

definition is consistent with EPA’s 

definition and with common usage of 

the term ‘‘surface water’’ (Ref. 101). We 

propose to define this term to 

distinguish ‘‘surface water’’ from other 

water, such as water from an 

underground aquifer that has not been 

held or conveyed in a manner open to 

the environment (‘‘ground water’’) 

because there is a greater likelihood that 

surface water could become 

contaminated, for example, by surface 

runoff. 

We propose to define ‘‘table waste’’ to 

mean any post-consumer food waste, 

irrespective of whether the source 

material is animal or vegetative in 

origin, derived from individuals, 

institutions, restaurants, retail 

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operations, or other sources where the 

food has been served to a consumer. 

This definition is intended to 

distinguish post-consumer food waste 

from pre-consumer vegetative waste. 

We propose to define ‘‘turned 

composting’’ to mean a process to 

produce humus in which air is 

introduced into biological material (in a 

pile, row, or enclosed vessel) by turning 

on a regular basis. Turning is the 

process of mechanically mixing 

biological material that is undergoing a 

composting process with the specific 

intention of moving the outer, cooler 

sections of the material being 

composted to the inner, hotter sections. 

The proposed definition is consistent 

with definitions or explanations of 

‘‘windrow composting’’ in documents 

prepared by the U.S. EPA (Ref. 92. Ref. 

91), the Produce Safety Project Issue 

Brief on Composting of Animal Manures 

(Ref. 27), and a report from the Food 

and Agriculture Organization of the 

United Nations (Ref. 100). We are 

proposing to use the term ‘‘turned 

composting’’ rather than ‘‘windrow 

composting’’ so that the term describing 

this method would not be limited to use 

in ‘‘rows.’’ 

We propose to define ‘‘water 

distribution system’’ to mean a system 

to carry water from its primary source 

to its point of use, including pipes, 

sprinklers, irrigation canals, pumps, 

valves, storage tanks, reservoirs, meters, 

and fittings. The proposed definition 

would provide a simple term to use 

when describing such systems. 

We propose to define ‘‘we’’ to mean 

the U.S. Food and Drug Administration. 

We propose to define ‘‘yard 

trimmings’’ to mean purely vegetative 

matter resulting from landscaping 

maintenance or land clearing 

operations, including materials such as 

tree and shrub trimmings, grass 

clippings, palm fronds, trees, tree 

stumps, untreated lumber, untreated 

wooden pallets, and associated rocks 

and soils. This proposed definition is 

consistent with a definition in State 

composting regulations (Ref. 90), except 

that we are proposing to use the term 

‘‘yard trimmings’’ rather than ‘‘yard 

trash.’’ We are proposing to use the term 

‘‘yard trimmings’’ to avoid potentially 

negative connotations associated with 

the word ‘‘trash,’’ even though some 

components of our proposed definition 

(e.g., untreated wooden pallets) arguably 

are not ‘‘trimmings.’’ We request 

comment on whether our proposed use 

of the term ‘‘yard trimmings’’ is 

appropriate for the purpose of this rule, 

or whether we should propose to use a 

term other than ‘‘yard trimmings,’’ such 

as ‘‘yard trash’’ or ‘‘yard waste.’’ 

We propose to define ‘‘you’’ to mean 

a person who is subject to some or all 

of the requirements in this part. 

c. Persons Subject to This Rule 

Proposed § 112.4(a) states that, except 

as provided in paragraph (b) of that 

section, if you are a farm or farm mixedtype 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 farm’’ subject to this part; 

however, specific exemptions and 

partial exemptions apply. If you are a 

covered farm subject to this part, you 

must comply with all applicable 

requirements of this part when you 

conduct a covered activity on covered 

produce. We are proposing to apply this 

proposed rule only to farms and farm 

mixed-type facilities with an average 

annual monetary value of food (as 

‘‘food’’ is defined in § 112.3(c)) sold 

during the previous three-year period of 

more than $25,000 (on a rolling basis) 

because we have tentatively concluded 

that farms with $25,000 or less in sales 

do not contribute significantly to the 

produce market. Farms below the 

$25,000 limit collectively account for 

only 1.5% of covered produce acres, 

suggesting that they contribute little 

exposure to the overall produce 

consumption. We note that such farms 

are and will continue to be covered 

under the adulteration provisions and 

other applicable provisions of the 

Federal Food, Drug, and Cosmetic Act 

and applicable implementing 

regulations, irrespective of whether they 

are included within the scope of this 

proposed rule. 

As proposed, § 112.4(a) would make 

clear that the rule applies to both farms 

and farm mixed-type facilities, and that 

such entities would be subject to the 

rule when they conduct a covered 

activity on covered produce, as those 

terms are defined in proposed 

§ 112.3(c). This would mean that, for 

example, a farm mixed-type facility that 

is a covered farm and that grows, 

harvests, packs, and holds its own 

lettuce would be subject to the proposed 

rule when conducting those activities 

(unless an exemption applies, such as 

that in proposed § 112.4(b)). However, 

the covered farm would not be subject 

to the rule when conducting other 

activities that are not covered activities, 

or when conducting operations on food 

other than covered produce. For 

example, if the farm mixed-type facility 

applied a manufacturing/processing 

step (such as chopping) to its lettuce for 

distribution into commerce (i.e., not for 

consumption on the farm or another 

farm under the same ownership, or for 

personal consumption), this would not 

be a ‘‘covered activity’’ as that term is 

defined in proposed § 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 for eligibility for a qualified 

exemption and associated special 

requirements based on average 

monetary value of all food sold and 

direct farm marketing. This exemption 

is mandated by Section 419(f) of the 

FD&C Act. Except as provided in 

§ 112.6, you would be exempt from all 

of the requirements of this part, except 

proposed subparts except A, Q, and R, 

in a calendar year if: 

• During the previous 3-year period 

preceding the applicable calendar year, 

the average annual monetary value of 

the food you sold directly to qualified 

end-users during such period exceeded 

the average annual monetary value of 

the food you sold to all other buyers 

during that period (§ 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 applicable calendar year 

was less than $500,000, adjusted for 

inflation, the baseline year for 

calculating the adjustment for inflation 

is 2011. The conditions related to 

average annual monetary value 

established in section 419(f)(1)(B) of the 

FD&C Act allow adjustment for 

inflation. To establish a level playing 

field for all farms that may satisfy the 

criteria for the qualified exemption, we 

are proposing to establish the baseline 

year for the calculation in proposed 

§ 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, 

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3550 Federal Register / Vol. 78, No. 11 / Wednesday, January 16, 2013 / Proposed Rules 

or farmers markets. It does seem likely 

that many such operations will meet the 

criteria for qualified exemption. Each 

such operation would need to analyze 

its sales under the terms of § 112.5 to 

determine its eligibility for the qualified 

exemption. For example, if a you-pick 

operation has an average annual 

monetary value of food sold during the 

relevant 3-year period of less than 

$500,000, and all of its sales were to 

individuals who come to the farm to 

pick their own produce, all of its sales 

would be sales to consumers (who are 

qualified end-users, regardless of 

location) for the purpose of determining 

the proportion of the sales that are to 

qualified end-users. In this example, the 

you-pick farm would be eligible for the 

qualified exemption. As another 

example, if a CSA farm has an average 

annual monetary value of food sold 

during the relevant 3-year period of less 

than $500,000; and 25% of the monetary 

value of its sales comes from sales to 

individual consumers enrolled in the 

CSA, 50% of the monetary value of its 

sales comes from sales to restaurants in 

the same state as the farm, and 25% of 

the monetary value of its sales comes 

from sales to other buyers who are not 

qualified end-users; the CSA farm 

would be eligible for the qualified 

exemption. In this example, the CSA 

farm’s sales to qualified end-users 

(consumers and in-state restaurants) 

make up 75% of the average annual 

monetary value of food sold, so the 

value of the farm’s sales to qualified 

end-users exceed the value of its sales 

to all other buyers during the relevant 

time period. 

ii. Applicable Requirements for 

Qualified Exemptions 

Proposed § 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 qualified exemption under 

§ 112.5. This is because subpart A 

contains this provision and other 

general provisions such as definitions, 

Subpart Q contains provisions related to 

compliance and enforcement, and 

subpart R contains provisions necessary 

to implement section 419(f)(3) of the 

FD&C Act, as discussed further in 

section V.R. of this document. 

Consistent with section 419(f)(2) of the 

FD&C Act, proposed § 112.6(b) 

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) 

would require that, when a food 

packaging label is required on food that 

would otherwise be covered produce 

under the FD&C Act or its implementing 

regulations, you include prominently 

and conspicuously on the food 

packaging label the name and complete 

business address of the farm where the 

produce was grown. Proposed 

§ 112.6(b)(2) requires that, when a food 

packaging label is not required on food 

that would otherwise be covered 

produce under the FD&C Act, you 

prominently and conspicuously display, 

at the point of purchase, the name and 

complete business address of the farm 

where the produce was grown. As 

proposed, the name and address of the 

farm must be displayed on a label, 

poster, sign, placard, or documents 

delivered contemporaneously with the 

produce in the normal course of 

business, or, in the case of Internet 

sales, in an electronic notice. That is, if 

a label is otherwise required on the 

produce that would otherwise be 

covered (for example, tomatoes in a 

‘‘clam shell’’ package) then the label 

must include the name and business 

address of the farm where the produce 

was grown. If a label is not required (for 

example, unpackaged tomatoes) then 

the name and business address of the 

farm where the produce was grown 

must be displayed at the point of 

purchase (such as on a poster, for 

example). These proposed provisions 

reflect our interpretation of section 

419(f)(2)(A)(i) and (ii) as applying only 

to food that would otherwise be covered 

produce but for the qualified exemption. 

We tentatively conclude that this 

interpretation is reasonable because 

applying these consumer notification 

requirements to food that would not 

otherwise be covered produce would 

mean applying requirements to food 

that bears no relationship to the subject 

of this rulemaking (e.g., to milk from a 

farm that also grows and harvests 

produce and that meets the criteria for 

the qualified exemption from this 

proposed rule). 

Proposed 112.6(b)(3) states that the 

complete business address that you 

must include in accordance with the 

requirements of paragraph (b)(1) or (2) 

of this section must include the street 

address or post office box, city, state, 

and zip code for domestic farms, and 

comparable full address information for 

foreign farms. Proposed § 112.6(b)(3) 

would enable consumers to contact the 

farm where the food that would 

otherwise be covered produce was 

grown (e.g., if the consumer identifies or 

suspects a food safety problem with a 

the produce) irrespective of whether the 

produce bears a label. The use of the 

term ‘‘business address’’ in section 

419(f)(2)(A) of the FD&C Act contrasts 

with Congress’ use of a different term, 

‘‘place of business,’’ in section 403(e) of 

the FD&C Act (21 U.S.C. 343(e)). Section 

403(e) provides that foods in package 

form are misbranded unless the product 

label bears the name and place of 

business of the manufacturer, packer, or 

distributor of the food. Our regulations 

interpret ‘‘place of business’’ as 

requiring only the firm’s city, state, and 

zip code to appear on the product label, 

as long as the firm’s street address is 

listed in a current telephone directory or 

other city directory (21 CFR 101.5(d)). 

We tentatively conclude that the use of 

the term ‘‘business address’’ in section 

419(f)(2)(A) demonstrates Congress’ 

intent to require the farm’s full address, 

including the street address or P.O. box, 

to appear on labels or other required 

notifications when the farm qualifies for 

the exemption in section 419(f) of the 

FD&C Act. If Congress had considered 

the less complete address already 

required under section 403(e)(1) of the 

FD&C Act and the ‘‘place of business’’ 

labeling regulation (§ 101.5(d)) to be 

adequate for notification to consumers 

for foods required to bear labels, there 

would have been no need to impose a 

new, more specific requirement in 

section 419(f)(2)(A)(1) for the farm’s 

‘‘business address’’ to appear on the 

food label. Requiring the complete 

business address for this purpose is 

consistent with our guidance to industry 

on the labeling of dietary supplements 

as required by the Dietary Supplement 

and Nonprescription Drug Consumer 

Protection Act (Ref. 103). When 

proposed § 112.5(b) would apply to a 

food for which a food packaging label is 

required under any other provision of 

the FD&C Act, the complete business 

address would substitute for the ‘‘place 

of business’’ required under section 

403(e)(1) of the FD&C Act and 21 CFR 

101.5(d) and would not impose any 

requirement for a label that would be in 

addition to any label required under any 

other provision of the FD&C Act. We 

seek comment on the feasibility of the 

labeling provisions in proposed 

112.6(b), particularly in the case of 

consolidating produce from several farm 

locations. 

Section 419 of the FD&C Act does not 

explicitly require farms that meet the 

criteria for the qualified exemption to 

establish and maintain documentation 

of the basis for their exemption. FDA 

considers that it may be necessary for 

farms to maintain such records, and to 

allow FDA access to such records upon 

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request, in order to efficiently enforce 

section 419 of the FD&C Act. Otherwise 

we would have no way to determine 

whether a farm claiming the qualified 

exemption actually met the criteria for 

that exemption. This could be 

important, for example, if a farm 

claiming the qualified exemption is 

directly linked to a foodborne illness 

outbreak during an active investigation 

or if FDA determines, based on conduct 

or conditions associated with the farm 

that are material to the safety of the food 

produced or harvested at such farm, that 

it is necessary to protect the public 

health and prevent or mitigate a 

foodborne illness outbreak to withdraw 

the farm’s qualified exemption (see 

section V.R. of this document discussing 

proposed subpart R). Because the 

withdrawal procedure in proposed 

subpart R would only apply to farms 

that are eligible for the qualified 

exemption, we would need to know 

whether the farm is indeed eligible for 

the exemption in order to select the 

appropriate and efficient enforcement 

strategy. We request comment on 

whether we should require farms to be 

able to provide adequate 

documentation, as needed, to 

demonstrate the basis for the qualified 

exemption. Specifically, we request 

comment on whether we should do this 

by requiring records to be established 

and maintained in accordance with the 

requirements of proposed subpart O, or 

if there is an alternative strategy by 

which we could require retention of and 

access to such records (such as by 

requiring farms only to retain records 

kept in the normal course of their 

business bearing on the criteria for the 

qualified exemption that they use to 

determine their eligibility and requiring 

FDA access to such records upon 

request). 

B. Subpart B—General Requirements 

As proposed, subpart B discusses the 

general requirements applicable to 

persons who are subject to this part and 

alternatives from the requirements 

established in this part that would be 

permitted, under specified conditions. 

1. Comments Relevant to Proposed 

Provisions 

We received several comments in 

response to the 2010 FR notice that 

addressed issues relevant to the general 

requirements established in this subpart 

of the rule. A consumer organization 

urged FDA to take additional steps to 

ensure the safety of bagged salads and 

all leafy greens. Some comments 

recommended that FDA include in this 

rule an amendment mechanism that can 

expeditiously accommodate new 

scientific knowledge. 

Section 402 of the FD&C Act specifies 

conditions under which a food is 

deemed adulterated, including if the 

food bears or contains any added 

poisonous or deleterious substance 

which may render it injurious to health 

(402(a)(1)); if it is unfit for food 

(402(a)(3)); or if it has been prepared, 

packed, or held under insanitary 

conditions whereby it may have become 

contaminated with filth, or whereby it 

may have been rendered injurious to 

health (402(a)(4)). In proposed § 112.11, 

we would specifically require that 

covered farms take appropriate 

measures to minimize the risk of serious 

adverse health consequences or death 

from the use of, or exposure to, covered 

produce, including those measures 

reasonably necessary to prevent the 

introduction of known or reasonably 

foreseeable hazards into covered 

produce as well as to provide reasonable 

assurances that the produce is not 

adulterated under section 402 of the 

FD&C Act on account of such hazards. 

Such hazards would include all 

pathogens to the extent that they pose 

a risk of serious adverse health 

consequences or death, including 

Salmonella and E. coli O157:H7, in all 

covered produce raw agricultural 

commodities, including leafy greens. 

With respect to bagged salads, we note 

that such salads are manufactured in 

facilities that are required to register 

with us and, therefore, would be 

covered under section 418 of the FD&C 

Act and any regulations promulgated 

pursuant to that authority, rather than 

by this proposed rulemaking. 

We recognize the value in making this 

regulation flexible, where appropriate, 

to accommodate future changes in 

science and technology. In proposed 

§ 112.12, we list the specific 

requirements established in this rule for 

which we believe alternatives may be 

appropriate and the circumstances 

under which such alternatives could be 

used. In addition, consistent with 

section 419(c)(2) of the FD&C Act, in 

proposed subpart P, we provide for a 

mechanism by which a State or a foreign 

country from which food is imported 

into the United States may request a 

variance from one or more requirements 

proposed in this part, where the State or 

foreign country determines that: (a) The 

variance is necessary in light of local 

growing conditions; and (b) the 

procedures, processes, and practices to 

be followed under the variance are 

reasonably likely to ensure that the 

produce is not adulterated under 

Section 402 of the Act and to provide 

the same level of public health 

protection as the requirements of this 

part (see section V.P. of this document). 

We also intend to publish guidance, as 

appropriate, to provide updates on 

current thinking with respect to best 

practices in produce safety. 

2. Proposed Requirements 

a. General Requirements Applicable to 

Persons Subject to This Part 

As proposed, § 112.11 establishes the 

general requirements applicable to 

persons who are subject to this rule. 

Proposed § 112.11 requires that you take 

appropriate measures to minimize the 

risk of serious adverse health 

consequences or death from the use of, 

or exposure to, covered produce, 

including those measures reasonably 

necessary to prevent the introduction of 

known or reasonably foreseeable 

hazards into covered produce, and to 

provide reasonable assurances that the 

produce is not adulterated under section 

402 of the FD&C Act on account of such 

hazards. 

This provision is consistent with the 

requirements of section 419(c)(1)(a) of 

the FD&C Act, which mandates, in 

relevant part, that we publish 

regulations that ‘‘set forth those 

procedures, processes, and practices 

that the Secretary determines to 

minimize the risk of serious adverse 

health consequences or death, including 

procedures, processes, and practices 

that the Secretary determines to be 

reasonably necessary to prevent the 

introduction of known or reasonably 

foreseeable biological, chemical, and 

physical hazards, including hazards that 

occur naturally, may be unintentionally 

introduced, * * * into fruits and 

vegetables, * * * and to provide 

reasonable assurances that the produce 

is not adulterated under section 402.’’ 

As discussed in section IV.B. of this 

document, we have tentatively 

concluded that this rule should focus 

solely on biological hazards. 

In subparts C to O, we propose 

science-based minimum standards 

related to the growing, harvesting, 

packing, and holding of covered 

produce that we believe are necessary to 

minimize the risk of serious adverse 

health consequences or death by 

preventing the introduction of hazards 

and providing reasonable assurances 

that the covered produce is not 

adulterated. 

Proposed § 112.11 would require, for 

example, that whenever a standard 

specified in this part is not met, you 

would take those steps reasonably 

necessary to identify and evaluate the 

cause of the problem and ensure that it 

is rectified. Accurate identification of 

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the cause of the failure is critical to the 

success of any potential corrective 

actions. For example, if your employees 

are having difficulty identifying covered 

produce that should not be harvested 

due to potential contamination, you 

might initially think the answer is to 

provide more frequent training; however 

upon investigation, you may discover 

that the actual cause of the problem is 

that your employee training program is 

providing inaccurate information. In 

this case, to correct the problem, you 

would need to fix your training 

program. Promptly taking such followup actions once the cause of the 

problem has been identified is necessary 

to minimize the risk of serious adverse 

health consequences or death from the 

use of, or exposure to, your covered 

produce and to provide reasonable 

assurances that the product is not 

adulterated under section 402 of the 

FD&C Act. 

In addition, proposed § 112.11 would 

require you to take appropriate 

measures to minimize risks of serious 

adverse health consequences or death 

from the use of, or exposure to, covered 

produce that may arise unexpectedly 

and therefore not be reflected in a 

specific standard set forth in proposed 

subparts C to O of this rule. For 

example, in the event of an unexpected 

event, such as receipt of information 

suggesting that your covered produce 

from a particular field is adulterated 

because it bears or contains a pathogen 

that may render the produce injurious to 

health, proposed § 112.11 would require 

you to take appropriate measures to 

minimize the risk of serious adverse 

health consequences or death from the 

use of, or exposure to, your covered 

produce by preventing the introduction 

of biological hazards into or onto your 

produce or by taking measures to 

provide reasonable assurances that the 

produce is not adulterated under section 

402 of the FD&C Act. Such measures 

might include, for example, conducting 

a root cause investigation to try to 

determine the source of the 

contamination, making appropriate 

changes to your conditions and 

practices suggested by the root cause 

investigation, including to produce in 

other fields, as appropriate, determining 

the extent of the impact of the root 

cause (i.e., within the suspect field and 

in other fields), and excluding 

adulterated produce from commerce. 

We note, however, that we do not 

intend for proposed § 112.11 to suggest 

that you would need to take measures 

to exclude animals from outdoor 

growing areas, to destroy animal 

habitats near your outdoor growing 

areas, to clear farm borders around 

outdoor growing areas or drainages, or 

to take any action that would violate 

applicable environmental laws or 

regulations. 

We propose to include proposed 

§ 112.11 in order to account for the 

variety of possible circumstances that 

might arise in which an unexpected 

circumstance or unique farm 

characteristics would justify preventive 

measures to prevent introduction of 

hazards or provide assurances against 

adulteration in order to minimize the 

risk of serious adverse health 

consequences or death. We request 

comment on this approach, and on 

whether we should instead establish 

specific standards for any types of 

hazards that would be covered in 

proposed § 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 

use of alternatives to certain 

requirements of this part. Subparagraph 

(a) lists the specific requirements for 

which alternatives may be considered 

provided you are in compliance with 

subparagraphs (b) and (c), which 

describe the conditions for use of an 

alternative. Proposed § 112.12(b) states 

that you may establish and use an 

alternative to any of the requirements 

listed in paragraph (a), provided you 

have adequate scientific data or 

information to support a conclusion that 

the alternative would provide the same 

level of public health protection as the 

applicable requirement established in 

this part (including meeting the same 

microbiological standards, where 

applicable) and would not increase the 

likelihood that your covered produce 

will be adulterated under section 402 of 

the FD&C Act, in light of your covered 

produce, practices, and conditions, 

including agro-ecological conditions 

and application interval. We do not 

propose to require you to submit such 

scientific data or information to us for 

review or approval prior to marketing. 

However, we would require that you 

maintain a record of any such scientific 

data or information, including any 

analytical information, and make such 

data and information available to us to 

evaluate upon request. 

Proposed § 112.12(c) clarifies that the 

scientific data and information used to 

support an alternative to a requirement 

may be developed by you, available in 

the scientific literature, or available to 

you through a third party, and further 

provides that documentation of such 

data and information must be 

established and maintained in 

accordance with the requirements of 

subpart O of this part. As discussed in 

section II.E.4. of this document, FDA is 

collaborating with partners on research 

that may provide scientific support for 

specific alternatives to certain of these 

requirements. FDA intends to issue 

guidance on specific alternatives that it 

may identify as meeting the 

requirements of the rule in order to 

assist farms in complying with the final 

rule. For example, a farm that applies 

crop protection sprays to the harvestable 

portion of crops (i.e., application of 

water containing crop protection 

substances using a direct water 

application method) several days before 

the crop is harvested using a water 

source that does not meet the 

requirements of § 112.44(c) (i.e, EPA 

generic E. coli ‘‘recreational water’’ 

standard), may use an alternative 

measure provided by their Cooperative 

Extension agent, for example, as long as 

the measure is based on scientifically 

sound data and meets the conditions 

described above (i.e., provides the same 

level of public health protection as the 

applicable requirement and does not 

increase the likelihood that covered 

produce will be adulterated). For 

example, the study might demonstrate 

that the quality of water used for direct 

application method irrigation is not 

important as long as there are at least 

two days between application and 

harvest, or that water of some lesser 

standard than that in § 112.44(c) could 

safely be applied immediately before 

harvest. The farm operator would 

maintain a copy of the information 

provided by the agent as documentation 

that the alternative measure was based 

on sound science. When FDA becomes 

aware of such information, it is our 

intention to include it in guidance, so 

that farm operators can also rely on FDA 

guidance for such alternative measures. 

As proposed in § 112.12(a), you may 

establish alternatives to the following 

requirements: 

(1) The requirements in § 112.44(c), 

for testing water, and taking action 

based on test results, when agricultural 

water is used during growing operations 

for covered produce (other than sprouts) 

using a direct water application method; 

(2) The composting treatment 

processes required in § 112.54(c)(1) and 

(2); 

(3) The minimum application interval 

established in § 112.56(a)(1)(i) for an 

untreated biological soil amendment of 

animal origin; and 

(4) The minimum application interval 

established in § 112.56(a)(4)(i) for a 

biological soil amendment of animal 

origin treated by a composting process. 

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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 

agricultural water is used during 

growing operations 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 

appropriate analytical methods in 

proposed subpart N. If you find that 

there is more than 235 CFU (or MPN, as 

appropriate) generic E. coli per 100 ml 

for any single sample or a rolling 

geometric mean (n=5) of more than 126 

CFU (or MPN, as appropriate) per 100 

ml of water, you must immediately 

discontinue use of that source of 

agricultural water and/or its distribution 

system for the uses described in that 

paragraph and before you may use the 

water source and/or its distribution 

system again for those uses, you must 

either: (1) Re-inspect the entire 

agricultural water system under your 

control, identify any conditions that are 

reasonably likely to introduce known or 

reasonably foreseeable hazards into or 

onto covered produce or food-contact 

surfaces, make necessary changes, and 

retest the water to determine if your 

changes were effective, or (2) treat the 

water in accordance with the 

requirements of § 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 water 

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 circumstances an alternative 

standard (e.g., a standard that applies an 

application interval (time between 

application and harvest) in place of the 

112.44(c) water standard, but is limited 

to a specific commodity or commodity 

group and region) may be appropriate if 

the alternative standard is shown to 

provide the same level of public health 

protection as the standard in proposed 

§ 112.44(c) and not to increase the 

likelihood that the covered produce will 

be adulterated. For example, we are 

working with USDA and other 

stakeholders to facilitate research into 

application intervals that would be 

commodity- and region-specific, such 

that water not meeting the proposed 

§ 112.44(c) standard could be used in a 

direct water application method for 

growing covered produce other than 

sprouts as long as it was applied before 

the start of the scientifically established 

application interval (i.e., at a certain 

number of days before harvest or 

earlier). Therefore, we tentatively 

conclude that it would be appropriate to 

allow for alternatives to the 

requirements in proposed § 112.44(c). 

Under proposed § 112.12(a)(2), you 

may 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 established 

in § 112.54(c)(1) and (2) as scientifically 

valid controlled composting processes 

demonstrated to satisfy the microbial 

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 insulation; and (2) Turned 

composting that maintains aerobic 

conditions at a minimum of 131 °F (55 

°C) for 15 days, with a minimum of five 

turnings, and is followed by adequate 

curing, which includes proper 

insulation. We tentatively conclude that 

it would be appropriate to allow for the 

use of other static or turned composting 

protocols that maintain conditions for a 

combination of temperatures and time 

other than the temperature and times 

specified in proposed §§ 112.54(c)(1) 

and (2), and is followed by adequate 

curing, which includes proper 

insulation, if they achieve the same 

level of pathogen reduction (i.e., meet 

the microbial standard in § 112.55(b)). 

In this sense, the microbial standards 

would provide a performance standard; 

practices that meet this objective 

measure would be acceptable. It would 

be your responsibility to consider the 

moisture content, pH, carbon to nitrogen 

ratio (C:N), feedstock, and any other 

appropriate consideration needed 

during composting to adequately 

achieve the microbial standards of 

proposed § 112.55(b). 

Under proposed § 112.12(a)(3), you 

may establish an alternative to the 

minimum application interval of nine 

(9) months, established in proposed 

§ 112.56(a)(1)(i), for an untreated 

biological soil amendment of animal 

origin that is reasonably likely to 

contact covered produce after 

application or for a compost agricultural 

tea that contains compost agricultural 

tea additives. As discussed in section 

V.F of this document, we have 

tentatively concluded that, under 

certain circumstances, the application 

interval in § 112.56(a)(1)(i) may be more 

than what is necessary for minimizing 

the likelihood that covered produce that 

is grown in soils amended with an 

untreated biological soil amendment, 

and is reasonably likely to contact the 

soil after application, pose to the public 

health. These circumstances could 

include differences in likelihood of 

contamination posed by the specific 

feedstock, application method or 

treatment method, especially given the 

potential for new innovations in such 

methods. 

Under proposed § 112.12(a)(4), you 

may establish an alternative to the 

minimum application interval of 45 

days, established in proposed 

§ 112.56(a)(4)(i), for a biological soil 

amendment of animal origin treated by 

a composting process in accordance 

with the requirements of proposed 

§ 112.54(c) that satisfies the microbial 

standard in proposed § 112.55(b), and 

that is reasonably likely to contact 

covered produce after application. As 

discussed in section V.F. of this 

document, we are proposing a multiplehurdle approach to minimizing the 

likelihood of contamination by addition 

of an application interval of 45 days to 

any biological soil amendment of 

animal origin treated by composting that 

is reasonably likely to contact covered 

produce after application. This time 

period has been shown to be effective 

when the population of the pathogen is 

minimal (Ref. 104) as can be expected 

of a fully composted biological soil 

amendment of animal origin. This 

multiple hurdle approach and time 

interval has also been utilized in current 

industry standards for leafy greens (Ref. 

31). We seek comments on this 

proposal. We have also tentatively 

concluded that, under certain 

circumstances, the application interval 

in § 112.56(a)(4)(i) may be more than 

what is necessary for minimizing the 

likelihood of contamination of covered 

produce that is grown in soils amended 

with a treated biological soil 

amendment, and that is reasonably 

likely to contact the soil after 

application. These circumstances could 

include differences in likelihood of 

contamination posed by the specific 

feedstock, application method or 

treatment method, especially given the 

potential for new innovations in such 

methods. 

As noted above, in any use of 

alternatives permitted in § 112.12(a)(1) 

through § 112.12(a)(4), in accordance 

with proposed § 112.12(b), you would 

be required to have adequate scientific 

data or information to support a 

conclusion that the alternative would 

provide the same level of public health 

protection as the requirement specified 

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in the proposed rule and would not 

increase the likelihood that your 

covered produce will be adulterated 

under section 402 of the FD&C Act. 

Further, in accordance with proposed 

§ 112.12(c), you must establish and 

maintain documentation of such 

scientific data or information, which 

may be developed by you, available in 

the scientific literature, or available to 

you through a third party. We are 

working with USDA and other 

stakeholders to conduct research on 

relevant alternative practices and intend 

to make the results of that research 

available in the future. We seek 

comment on whether we should require 

you to notify FDA of your conclusion to 

establish or use an alternative that is 

permitted under §§ 112.12(a)(1) through 

(a)(4), and whether we should require 

you to submit relevant scientific data or 

information to FDA as part of such a 

notification. 

C. Subpart C—Standards Directed to 

Personnel Qualifications and Training 

As proposed, subpart C discusses 

minimum standards directed to 

personnel qualifications and training 

that are reasonably necessary to 

minimize the risk of serious adverse 

health consequences or death from the 

use of, or exposure to, covered produce, 

including those reasonably necessary to 

prevent the introduction of known or 

reasonably foreseeable hazards into 

covered produce, and to provide 

reasonable assurances that the covered 

produce is not adulterated under section 

402 of the FD&C Act. 

1. Comments Related to Proposed 

Provisions 

We received several comments in 

response to the 2010 FR notice that 

addressed issues relevant to personnel 

qualifications and training. Several 

comments expressed concern over 

language and educational barriers 

greatly impeding the farm’s ability to 

effectively fulfill the training 

requirements for their field workers. 

They also stressed the need for far 

reaching, accurate, consistent, and wellrounded training programs with skilled 

trainers providing the same information 

to growers, processors and distributors. 

Comments further suggested that 

training materials should have 

addendums to reflect the differences 

among the varied growing regions, 

commodities, and production practices 

and processes, as well as train-thetrainer programs for individuals 

responsible for training farm workers. 

Many firms also urged organizations, 

universities, and extension agencies to 

share experiences and to provide 

resources for worker training. Several 

comments pointed out difficulties in 

training due to the transient or short 

term nature of farm workers and due to 

the seasonal relocation of their 

operations. In addition, comments 

expressed concern over the cost of 

implementation, including regular 

refresher courses and training materials, 

and the reliability of third-party training 

materials. One comment requested that 

individuals responsible for the training 

program and materials should ensure 

that curricula are updated to reflect any 

new scientific information. 

We believe that adequate and 

appropriate training of personnel who 

handle covered produce or food-contact 

surfaces, or who are engaged in the 

supervision thereof, is an essential 

component of standards for produce 

safety. Regardless of the nature of the 

farm workers, we propose that they 

must receive training upon hiring, at the 

beginning of each growing season, and 

with periodic updates as necessary in 

order to prevent contamination of 

covered produce. Farm workers need to 

know how to recognize potential 

contamination problems (e.g., a leafy 

green vegetable contaminated with 

manure) and to be trained to know what 

to do when those situations present 

themselves. The farm worker is a key 

component in the food chain for 

ensuring the safety of covered produce. 

No matter the transient nature, any 

worker can be a potential pathway for 

contamination of produce during 

growing, harvesting, packing, and 

holding (e.g., because of hygiene issues 

or illness) or fail to identify a situation 

that may result in contamination of the 

covered produce being grown, 

harvested, packed, or held if they are 

not cognizant of proper food safety 

procedures and standards. It is not 

uncommon for workers to change based 

on season and location and, therefore, 

proposed § 112.21(a) would require 

personnel to receive training upon 

hiring and at the beginning of each 

growing season (if applicable). Proposed 

§ 112.21(a) would also require that 

personnel receive periodic updates as a 

way of reminding them of the proper 

procedures including any changes in 

those procedures. Such updates may not 

require full training sessions, but only 

short descriptive sessions to ensure that 

all personnel remain aware of all 

procedures necessary to maintain the 

safety of produce. 

Together with the USDA, Cornell 

University’s National GAPs program, 

the Association of Food and Drug 

Officials (AFDO), and the National 

Association of State Departments of 

Agriculture (NASDA), we have formed 

the Produce Safety Alliance (PSA), 

which is a public-private partnership 

established to provide educational 

outreach assistance to fresh produce 

growers and packers. This program is in 

the process of creating training materials 

that will be both region- and 

commodity-specific. We expect these 

materials to be standardized, multiformatted, and multi-lingual, and 

available in pictorial format to help 

overcome literacy issues. Specific focus 

areas for the PSA include GAPs and comanagement education and outreach 

efforts for produce farmers and packers, 

with special emphasis on small-scale 

operations. This alliance will also 

include a train-the-trainer lesson plan 

and an education outreach program 

delivery for farmers, trainers, and 

regulators. We intend to explore the 

need for additional such partnerships, 

as appropriate, to address any 

commodity-specific needs for outreach 

and assistance. We welcome comments 

and suggestions for training 

development strategies. 

2. Proposed Requirements 

Proposed § 112.21 would establish 

requirements for the qualifications and 

training for personnel who handle 

(contact) covered produce or foodcontact surfaces, or who are engaged in 

the supervision thereof. Having 

personnel follow proper food hygiene 

practices, including personal health and 

hygiene, can reduce the potential for onfarm contamination of covered produce. 

Educating personnel who conduct 

covered activities in which they contact 

covered produce and supervisors about 

food hygiene, food safety, and the risks 

to produce safety associated with 

illnesses and inadequate personal 

hygiene is a simple step that can be 

taken to reduce the likelihood of 

pathogens being spread from or by 

personnel to covered produce. 

Most current FDA, private and 

international guidelines for the produce 

industry include provisions related to 

training food handlers in the importance 

of personal health and hygiene to food 

safety (Ref. 10. Ref. 20. Ref. 50. Ref. 48. 

Ref. 96. Ref. 26). As described in the 

QAR, FDA’s follow-up farm 

investigations in response to outbreaks 

and contamination events identified 

poor worker health and hygiene, unsafe 

produce handling and storage practices, 

and specifically poor training in these 

areas, as likely contributing factors to 

these events. This information 

reinforces the importance of training 

farm personnel, including supervisors, 

in food hygiene, food safety, employee 

health and personal hygiene. 

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Proposed § 112.21(a) would require 

that all personnel (including temporary, 

part time, seasonal and contracted 

personnel) who handle (contact) 

covered produce or food-contact 

surfaces and their supervisors receive 

training that is appropriate to the 

person’s duties, upon hiring, at the 

beginning of each growing season (if 

applicable), and periodically thereafter. 

Because ensuring that covered produce 

is not contaminated is dependent on 

personnel following proper food safety 

and hygiene practices, all personnel 

who contact covered produce and foodcontact surfaces must receive training 

when hired, before they participate in 

the growing, harvest, packing or holding 

of covered produce in which they 

contact covered produce, and must be 

periodically reminded about the need to 

follow these practices through refresher 

training. When a farm hires workers 

after the beginning of a growing season, 

these workers would need to be trained 

upon hiring. Because the farm does not 

employ these workers at the beginning 

of the first growing season, the 

requirement for training at the 

beginning of each growing season would 

not be applicable to those workers until 

the beginning of the next growing 

season, if they are still employed by the 

farm at that time. Managers and 

supervisors must have the necessary 

knowledge of food safety and hygiene 

principles and practices to be able to 

assess whether their staff are following 

appropriate practices, and take the 

necessary action to remedy any 

deficiencies, which could include onthe-spot training for their staff. 

Periodic refresher training for all 

relevant personnel, including managers 

and supervisors, is necessary to ensure 

continual awareness of important food 

safety and hygiene principles. It is also 

important when new information is 

available about practices that may 

contribute to foodborne illness or when, 

for that reason or other reasons, changes 

in the farm’s procedures are put in 

place. For example, during the past 

decade several segments of the produce 

industry reviewed and revised their 

industry guidelines or developed new 

guidelines to address current food safety 

concerns relative their specific 

commodity (i.e., lettuce, tomatoes, 

sprouts, and cilantro). 

Proposed § 112.21(b) would require 

that all personnel (including temporary, 

part time, seasonal and contracted 

personnel) who handle (contact) 

covered produce or food-contact 

surfaces and their supervisors have the 

training, in combination with education 

or experience, to perform the person’s 

assigned duties in a manner that ensures 

compliance with this part. Proposed 

§ 112.21(b) would provide flexibility for 

how personnel become qualified to 

perform their assigned duties by 

recognizing multiple pathways to obtain 

the necessary qualifications: Training 

(such as training provided on-the-job), 

in combination with education, or 

experience (e.g., work experience 

related to an employee’s current 

assigned duties). The standards in 

subparts C through O often involve 

action by farm personnel (e.g., 

monitoring of animal intrusion, 

inspecting agricultural water system) 

that require specific knowledge, skills 

and abilities, without which the 

standard could not be properly 

achieved. Proposed § 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. 

The goals of training cannot be achieved 

if the person receiving the training 

cannot understand it. Training could be 

understood by personnel being trained 

if, for example, it was conducted in the 

language that employees customarily 

speak and at the appropriate level of 

education. In some cases in may be 

necessary to use easily understood 

pictorials or graphics of important 

concepts (Ref. 105). 

Proposed § 112.21(d) would establish 

requirements for training to be repeated 

as necessary and appropriate in light of 

observations or information indicating 

that personnel are not adequately 

meeting standards established by FDA 

in subparts C through O of the rule. The 

goals of training are not achieved if the 

persons receiving the training do not 

correctly implement those standards 

taught. Moreover, repeated training as 

proposed in § 112.21(d) is necessary 

when an employee that does not follow 

the correct food safety protocol, because 

such behavior may increase the 

likelihood of introducing a food safety 

hazard to covered produce. When an 

employee requires additional training, it 

may consist of informal on-the-spot 

instruction to focus on those measures 

not being adequately implemented as 

opposed to more comprehensive 

training. For example, if you observe an 

employee commit a minor error, such as 

an inappropriate method for recording 

monitoring information in a log, an 

appropriate action could be to show the 

employee the correct method of 

recording the information and contrast 

this with the inappropriate method the 

employee had been using. However, if 

an employee displays repeated mistakes 

or a fundamental misunderstanding of 

the correct procedures for handling 

covered produce, an appropriate action 

may be to have the employee repeat 

relevant training, or to attend a 

comprehensive training course. If you 

conclude that the employee may not 

have the skills to conduct certain 

covered activities, an appropriate action 

may be to train the employee for new 

responsibilities that are more suitable to 

his or her skills. 

Proposed § 112.22(a) would require 

that, at a minimum, all personnel who 

handle (contact) covered produce 

during covered activities must receive 

training that would include: (1) 

Principles of food hygiene and food 

safety (proposed § 112.22(a)(1)); (2) the 

importance of health and personal 

hygiene for all personnel and visitors, 

including recognizing symptoms of a 

health condition that is reasonably 

likely to result in contamination of 

covered produce or food-contact 

surfaces with microorganisms of public 

health significance (proposed 

§ 112.22(a)(2)); and (3) the standards as 

applicable to the employee’s job 

responsibilities, including those 

established by FDA in subparts C 

through O of this part (proposed 

§ 112.22(a)(3)). 

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. Training in 

the principles of food hygiene and food 

safety are necessary to provide an 

overall framework for job performance. 

Training in health, hygiene, and disease 

control can teach workers how to 

minimize the likelihood of transferring 

pathogens to covered produce. These 

topics are covered in several currently 

used guidance documents (Ref. 10. Ref. 

20. Ref. 50. Ref. 48. Ref. 96). In addition, 

training in the specific standards 

established in subparts C through O of 

this part which are necessary for the 

employee to use during the course of 

their duties will increase the likelihood 

that those standards will be 

implemented correctly and effectively. 

We seek comments on the scope, 

frequency, and methods outlined in the 

proposed training sections of the 

proposed rule. 

Proposed § 112.22(b) would require 

that persons who conduct covered 

harvest activities for covered produce 

also receive training that includes all of 

the following: (1) Recognizing covered 

produce that should not be harvested, 

including covered produce that may be 

contaminated with known or reasonably 

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3556 Federal Register / Vol. 78, No. 11 / Wednesday, January 16, 2013 / Proposed Rules 

foreseeable food safety hazards 

(proposed § 112.22(b)(1)); (2) inspecting 

harvest containers and equipment to 

ensure that they are functioning 

properly, clean, and maintained so as 

not to become a source of contamination 

of covered produce with known or 

reasonably foreseeable food safety 

hazards (proposed § 112.22(b)(2)); and 

(3) correcting problems with harvest 

containers or equipment, or reporting 

such problems to the supervisor (or 

other responsible party), as appropriate 

to the person’s job responsibilities 

(proposed § 112.23(b)(3)). 

We tentatively conclude that the topic 

areas addressed in proposed § 112.22(b), 

in addition to § 112.22(a), are those 

minimum topic areas necessary to be 

covered during training for persons who 

conduct harvest activities. Harvest 

workers need to learn how to recognize 

produce that should not be harvested 

(such as rotten or decayed fruit, 

‘‘drops,’’ or harvestable items that have 

been contaminated with feces), because 

not harvesting such covered produce 

would be the first opportunity to 

prevent that produce from entering 

commerce, and as a practical matter 

may be the only such opportunity (for 

example, during a field-pack operation 

with no subsequent culling stage). 

Proposed § 112.112 would require that 

farms take all measures reasonably 

necessary to identify and not harvest 

covered produce that is visibly 

contaminated with animal excreta. 

Harvest workers must be trained to 

both recognize this condition and to 

avoid harvesting covered produce that 

exhibits the condition. Harvest workers 

also need to know how to inspect 

harvest containers and equipment to 

ensure that they are functioning 

properly, clean, and maintained so that 

they will not act as a source of 

contamination or lead to damage of 

covered produce (damaged produce is 

more likely to harbor pathogens, and at 

a greater population, than is sound 

produce (Ref. 59. Ref. 106)). Harvest 

workers also need to know how to 

correct problems with harvest 

equipment or containers when they 

encounter them, or need to know that 

they should report such problems to 

someone who would be responsible for 

ensuring that the problem is corrected. 

These topics are covered in several 

currently used relevant documents (Ref. 

8. Ref. 33. Ref. 18. Ref. 89. Ref. 84). We 

acknowledge the challenge these 

training requirements may pose to farms 

that employ contracted harvest crews. In 

such cases, we expect that the harvest 

crew company could provide the 

required training to workers, who move 

from farm to farm under the 

employment of the harvest crew 

company. Farms on which such harvest 

crews work could request certification 

from the harvest crew company that 

their workers have received the required 

training. We seek comment on the 

feasibility of the proposed training 

requirements, particularly with respect 

to harvest activities. 

Proposed § 112.22(c) would require 

that at least one supervisor or 

responsible party for your farm 

successfully complete food safety 

training at least equivalent to that 

received under standardized curriculum 

recognized as adequate by the Food and 

Drug Administration. Experience at 

farming does not necessarily convey 

knowledge of food safety, particularly 

that of microbial food safety hazards, 

and therefore specialized training is 

needed to address the specific concerns 

of on-farm food safety. The purpose of 

training a supervisor or other 

responsible party is so that person can 

help train other employees, recognize 

conditions that could lead to 

contamination of covered produce, and 

take action to correct those conditions. 

As discussed in section II.D. of this 

document, FDA has, together with 

USDA AMS, established the jointly 

funded PSA, a public-private 

partnership that will develop and 

disseminate science- and risk-based 

training and education programs to 

provide produce growers and packers 

with fundamental, on-farm food safety 

knowledge, starting in advance of this 

proposed rule and continuing after the 

final regulation is promulgated. A first 

phase of PSA’s work is intended to 

assist growers, especially small growers, 

in establishing food safety programs 

consistent with the GAPs Guide and 

other existing guidances and 

requirements so that they will be better 

positioned to comply with a final 

produce rule. As this rulemaking 

progresses, FDA will work to ensure 

that the PSA materials are modified, as 

needed, to be consistent with the 

requirements of this rule. Included in 

that material will be the standardized 

curriculum against which FDA intends 

to compare other training programs. 

After reviewing the final draft of the 

PSA training materials, FDA intends to 

publish a notice of availability of the 

documents in the Federal Register. We 

would encourage trainers outside the 

PSA to evaluate their courses, past, 

present, and future, against the PSA 

materials when they become available 

and to modify or adapt curricula, where 

necessary, to ensure that they are 

consistent with, and provide at least an 

equivalent level of instruction to, the 

Alliance course. We have no plans to 

publish a list of ‘‘approved’’ courses 

other than the Alliance course materials. 

Proposed § 112.23 would require that 

you assign or identify personnel to 

supervise (or otherwise be responsible 

for) your operations to ensure 

compliance with the requirements of the 

rule. Oversight by a qualified individual 

is essential to the effective 

implementation of the rule. Under 

proposed § 112.23, the personnel that 

you assign or identify to supervise (or 

otherwise be responsible for) your 

operations may be a single person 

(including yourself), or may be a team 

of individuals, each with specific areas 

of responsibility (e.g., you may assign or 

identify separate persons to be 

responsible for your water distribution 

system, your harvest activities, your 

sanitary accommodations, and your 

packing activities). 

Proposed § 112.30(a) would require 

that you establish and keep records 

required under subpart C in accordance 

with the requirements of subpart O of 

the rule. Proposed § 112.30(b) would 

require that you establish and keep 

records that document required training 

of personnel, including the date of the 

training, the topics covered, and the 

person(s) trained. An example of 

records that would comply with 

proposed § 112.30(b) is an attendance 

sheet with the date, list of those in 

attendance, and the particular topics 

covered (such as proper hand washing 

or how to collect samples for water 

testing). The records required by 

proposed § 112.30(b) would enable you 

to track the training personnel receive, 

thereby enabling you to identify 

personnel and training topics for 

periodic updates and personnel that 

have the prerequisite training for 

assignment to certain responsibilities. 

Such records would enable you to 

document that a person has, as would 

be required under proposed §§ 112.21(a) 

and (b), successfully completed training 

as appropriate to the person’s duties, 

upon hiring and periodically thereafter, 

including the principles of food hygiene 

and food safety and also the training 

that would be specific to a person’s 

tasks and responsibilities. 

D. Subpart D—Standards Directed to 

Health and Hygiene 

As proposed, subpart D discusses 

science-based minimum standards 

directed to health and hygiene that are 

reasonably necessary to minimize the 

risk of serious adverse health 

consequences or death from the use of, 

or exposure to, covered produce, 

including those reasonably necessary to 

prevent the introduction of known or 

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Federal Register / Vol. 78, No. 11 / Wednesday, January 16, 2013 / Proposed Rules 3557 

reasonably foreseeable hazards into 

covered produce, and to provide 

reasonable assurances that the produce 

is not adulterated under section 402 of 

the FD&C Act. 

1. Comments Relevant to Proposed 

Provisions 

We received some comments in 

response to the 2010 FR notice that 

addressed issues relevant to health and 

hygiene. Several comments noted the 

challenges of enforcing use of gloves 

and clean clothes. Others expressed 

concerns related to identifying sick 

employees who could contaminate 

covered produce or food-contact 

surfaces, while another comment asked 

about potential requirements on 

hygienic practices and questioned 

whether hand jewelry could 

contaminate produce such as leafy 

greens. 

We recognize the importance of taking 

appropriate measures to prevent sick or 

infected persons from contaminating 

covered produce or food-contact 

surfaces. In proposed § 112.22(a)(2), we 

propose to require training of personnel 

to recognize symptoms of a health 

condition that is reasonably likely to 

result in contamination of covered 

produce or food-contact surfaces with 

microorganisms of public health 

significance. The proposed 

requirements for standards directed to 

health and hygiene focus on 

maintaining adequate personal 

cleanliness. Gloves can provide a barrier 

to reduce the potential for 

contamination; however, gloves 

themselves can transfer pathogens to 

covered produce if they become 

contaminated. Therefore, while we are 

not proposing to require the use of 

gloves, we are proposing to require the 

proper use of gloves when workers wear 

them (proposed § 112.32(b)(4)). Clothes 

should be adequately clean if by virtue 

of type of operation the workers are 

performing, the clothes could 

potentially contaminate covered 

produce with pathogens. 

2. Proposed Requirements 

Proposed subpart D would require 

that you take those measures that we 

tentatively conclude are reasonably 

necessary to prevent personnel and 

visitors from introducing known or 

reasonably foreseeable hazards into or 

onto covered produce or food-contact 

surfaces. As discussed above (see 

sections I.A. of this document, and 

QAR), people can carry a wide variety 

of pathogens (including hepatitis A 

virus, Salmonella, E. coli O157:H7, 

Shigella, Cyclospora, and 

Cryptosporidium (Ref. 93) (Ref. 107). 

Bacteria, viruses, and parasites are 

frequently transmitted from person to 

person and from person to food, 

particularly through the fecal-oral route 

(Ref. 95. Ref. 96. Ref. 97. Ref. 98. Ref. 

93). Several of the provisions of 

proposed subpart D are similar to 

requirements in our Current Good 

Manufacturing Practice regulations for 

food and for dietary supplements 

(§ 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 measures necessary to prevent 

ill or infected persons from 

contaminating covered produce with 

microorganisms of public health 

significance. Proposed § 112.31(a) 

would require that you take measures to 

prevent contamination of covered 

produce and food-contact surfaces with 

microorganisms of public health 

significance from any person with an 

applicable health condition (such as 

communicable illnesses that present a 

public health risk in the context of 

normal work duties, infection, open 

lesion, vomiting, or diarrhea). 

Proposed § 112.31(b)(1) would require 

that you exclude any person from 

working in any operations that may 

result in contamination of covered 

produce or food-contact surfaces with 

microorganisms of public health 

significance when the person (by 

medical examination, the person’s 

acknowledgement, or observation (for 

example, by a supervisor or responsible 

party)) is shown to have, or appears to 

have, an applicable health condition, 

until the person’s health condition no 

longer presents a risk to public health. 

Applicable health conditions would not 

include non-communicable diseases 

such as cancer, diabetes, or high blood 

pressure, or non-communicable 

conditions such as pregnancy, which 

would not present a likelihood of 

contamination to covered produce or 

food contact surfaces. For example, if an 

employee tells you that his or her 

physician has diagnosed that the 

employee has a fever, and the employee 

normally handles your covered produce, 

you must take steps to ensure that the 

employee does not come into contact 

with your covered produce because the 

fever may suggest that the employee has 

an infection and there is a reasonable 

possibility of contamination. Likewise, 

if you see that an employee has an open 

wound or sore, and the employee 

normally handles covered produce, you 

must take steps to ensure that he or she 

is excluded from handling covered 

produce if the wound could be a source 

of microbial contamination. Proposed 

§ 112.31(b)(1) is similar to requirements 

in current §§ 110.10(a) and 111.10(a) 

and to provisions in our GAPs Guide 

(Ref. 10), the AFDO Model Code, 

various produce industry guidelines 

(Ref. 89. Ref. 84. Ref. 99), and a 

marketing agreement (Ref. 31), and the 

Codex Code (Ref. 96). 

Proposed § 112.31(b)(2) would require 

that you instruct your personnel to 

notify their supervisor(s) (or a 

responsible party) if they have, or if 

there is a reasonable possibility that 

they have, an applicable health 

condition. Consistent with the training 

requirement proposed in § 112.22(a)(2), 

we are proposing this requirement as a 

measure specifically directed at 

preventing sick or infected persons from 

contaminating covered produce or foodcontact surfaces and to emphasize that 

individual workers have a 

responsibility—every day—to take 

action to prevent contamination due to 

their own illness or infection. In a small 

or very small business, such as a farm 

largely operated by a husband and wife, 

the impact of proposed § 112.31(b)(2) 

would, in essence, be for a sick worker 

to take appropriate steps to exclude 

himself or herself from working in any 

operations that may result in 

contamination of covered produce or 

food-contact surfaces with pathogens. 

Proposed § 112.31(b)(2) is similar to 

requirements in current §§ 110.10(a) and 

111.10(a) and to provisions in the AFDO 

Model Code (Ref. 20), and a produce 

industry guideline ( (Ref. 46). We seek 

comments on the notification and other 

proposed requirements related to 

workers health. 

Proposed § 112.32 would require that 

personnel use certain hygienic 

practices. Proposed § 112.32(a) would 

require that personnel who work in an 

operation in which covered produce or 

food-contact surfaces are at likelihood of 

contamination with known or 

reasonably foreseeable hazards use 

hygienic practices while on duty to the 

extent necessary to protect against such 

contamination. Hygienic practices can 

prevent introduction of microbial (such 

as bacteria and viruses that could be 

present in saliva or on skin) 

contamination of covered produce (Ref. 

108). Inadequate hygienic practices 

among workers have been associated 

with outbreaks transmitted by various 

produce commodities, including 

strawberries, green onions, mamey, leaf 

lettuce, and basil (Ref. 107). Proposed 

§ 112.32(a) is similar to requirements in 

current §§ 110.10(b) and 111.10(b) and 

to provisions in our GAPs Guide (Ref. 

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3558 Federal Register / Vol. 78, No. 11 / Wednesday, January 16, 2013 / Proposed Rules 

44), the AFDO Model Code (Ref. 20), 

various produce industry guidelines 

(Ref. 46. Ref. 44), a marketing agreement 

(Ref. 31), and the Codex Code (Ref. 96). 

Proposed § 112.32(b) would require 

that personnel who handle (contact) 

covered produce use specific hygienic 

practices to satisfy the requirements of 

proposed § 112.32(a). Proposed 

§ 112.32(b)(1) would require the specific 

practice of maintaining adequate 

personal cleanliness to protect against 

contamination of covered produce and 

food-contact surfaces. Requiring that 

workers maintain adequate personal 

cleanliness is similar to requirements in 

current §§ 110.10(b) and 111.10(b) and 

to provisions in the Codex Code (Ref. 

96). We would expect that maintaining 

adequate personal cleanliness would 

include wearing adequate outer 

garments as necessary and appropriate 

to protect against contamination of 

covered produce and food-contact 

surfaces. Outer garments (e.g., smocks, 

aprons, or coveralls worn over a 

worker’s personal clothing) may be 

necessary and appropriate when a 

worker conducts an activity that has 

increased potential to contaminate the 

worker’s personal garments with 

hazards that could be transferred to 

covered produce or food-contact 

surfaces during subsequent activities in 

which the worker may contact covered 

produce. For example, a worker’s 

personal clothing could become 

contaminated with pathogens while a 

worker shovels manure, and such 

contamination could be transferred from 

the clothing to covered produce if the 

worker subsequently harvests covered 

produce wearing the same clothes. An 

apron, smock, or coverall worn over the 

worker’s personal clothing while 

shoveling the manure could simply be 

removed before the worker moves on to 

a harvest activity, which would reduce 

the likelihood of contaminating covered 

produce during the subsequent harvest 

activity. We intend to provide further 

information about adequate worker 

personal cleanliness in guidance. 

Proposed § 112.32(b)(2) would require 

that personnel avoid contact with 

animals other than working animals, 

and that personnel in direct contact 

with working animals take appropriate 

steps to minimize the likelihood of 

contamination of covered produce. 

Pathogens can be directly transmitted 

from animals to people when persons 

touch, pet, feed, or are licked by animals 

because animal hair, fur, saliva and skin 

can harbor pathogens (Ref. 98. Ref. 99. 

Ref. 100). For example, transmission of 

the pathogen Giardia lamblia from 

animals to humans was linked to an 

outbreak of foodborne illness associated 

with consumption of contaminated 

produce (Ref. 109). 

Proposed § 112.32(b)(3) would require 

that personnel wash hands thoroughly, 

including scrubbing with soap and 

running water that satisfies the 

requirements of § 112.44(a) (as 

applicable) for water used to wash 

hands, and that personnel dry hands 

thoroughly using single-service towels, 

clean cloth towels, sanitary towel 

service or other adequate hand drying 

devices on specified occasions. Those 

specified occasions include before 

starting work; before putting on gloves; 

after using the toilet; upon return to the 

work station after any break or other 

absence from the work station; as soon 

as practical after touching animals 

(including livestock and working 

animals) or any waste of animal origin; 

and at any other time when the hands 

may have become contaminated in a 

manner that is reasonably likely to lead 

to contamination of covered produce 

with known or reasonably foreseeable 

hazards. Under proposed § 112.32(b)(3), 

we would not expect workers to 

immediately stop work and wash their 

hands each time hands become soiled 

during the usual course of farm work 

with dirt or plant litter. However, we 

would expect workers to have sufficient 

training to recognize potential sources 

of hazards and to wash their hands 

when appropriate. We tentatively 

conclude that proposed § 112.32(b)(3) 

provides sufficient flexibility for 

operations to provide running water in 

a manner best suited to the conditions 

of use. For example, water can be 

supplied by a Public Water System, 

private well, or other source satisfying 

the requirements of § 112.44(a) through 

plumbed connections to building 

faucets (e.g., inside a packing house) to 

supply running water throughout the 

facility. Alternatively, water supplied 

from sources above and used to fill 

clean, portable water containers suited 

to field use (such as a carboy, tank, 

water buffalo, or similar container) 

fitted with a valve, spout, or spigot such 

that water released passes over the 

hands also can provide adequate 

running water for washing hands. Under 

proposed § 112.44(a), with certain 

exceptions set forth in proposed 

§ 112.45, you must test the quality of 

water used for hand washing during and 

after harvest to ensure that there is no 

detectable generic E. coli (see section 

V.E. of this document). 

Workers often touch produce with 

their bare hands, and the produce 

covered by this rule would not 

necessarily have a ‘‘kill step’’ to 

adequately reduce pathogens that could 

be transmitted through bare-hand 

contact. Hand-washing, when done 

effectively, can eliminate both resident 

bacterial contamination (such as on the 

hands of a worker who may not realize 

he is ill or infected) and transient 

microbial contamination (such as 

bacteria, viruses, and parasites that gets 

onto hands through contact with the 

environment) (Ref. 110). As a result, 

hand-washing is a key control measure 

in preventing contamination of covered 

produce and food-contact surfaces (Ref. 

26). The effectiveness of hand-washing 

is determined by multiple factors, 

including whether or not soap is used, 

the quality of water used, the duration 

of scrubbing and rinsing, and whether 

hands are dried. Soap serves as an 

emulsifier that enables dirt and oil to be 

suspended and washed off (Ref. 110). 

Rinsing hands without using soap, and 

not drying hands after washing, can 

promote the spread of microorganisms. 

For example, rinsing hands without 

using soap can loosen microorganisms 

without removing them, leaving the 

microorganisms more readily 

transferable to the next surface touched 

(Ref. 110). An investigation in follow-up 

to an outbreak of foodborne illness 

caused by E. coli O157:H7 in Florida 

found an association between illness 

and visits to fairs where visitors came in 

contact with animals, and found that 

persons who washed their hands with 

soap and water had a decreased 

likelihood of illness (Ref. 111). Drying 

hands is important because wet skin is 

more likely to transmit microorganisms 

than dry skin (Ref. 110). In addition, 

hand-drying has been demonstrated to 

remove bacteria from the hands and 

decrease ‘‘touch-contact-associated 

bacterial transfer’’ after hand-washing 

(Ref. 112). Proposed § 112.32(b)(3) does 

not prohibit use of hand sanitizers as a 

part of the hand washing process. 

However, our review of hand washing 

indicates that soap and water are far 

more effective than sanitizers in 

removing pathogens. The effectiveness 

of hand sanitizers has been shown to be 

highly dependent upon the removal of 

organic material from the hands prior to 

their use, as the presence of dirt, grease, 

or soil significantly reduces their 

effectiveness in eliminating bacteria on 

hands (Ref. 107). 

Proposed § 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 current §§ 110.10(b) and 

111.10(b). For example, proposed 

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§ 112.32(b) would not specify, in 

addition to the requirements for hand 

washing, that hands also be sanitized if 

necessary to protect against microbial 

contamination, while both §§ 111.10(b) 

and 111.10(b) have such a requirement. 

We tentatively conclude that the 

circumstances where use of a hand 

sanitizer as an additional measure to 

reduce likelihood of contamination with 

pathogens would be limited on a farm. 

Hand sanitizers are less likely to be 

effective on a farm than in a processing 

plant, since growers’ hands are more 

likely to get dirty during production on 

a farm and the resulting presence of 

organic material on the hands would 

impede the effectiveness of hand 

sanitizers (Ref. 113). 

In addition, proposed § 112.32(b)(3)(v) 

would specifically require washing 

hands after touching animals, a 

requirement that is not included in 

current § 110. We are proposing this 

requirement here because contact with 

animals is more likely to happen on a 

farm. In addition, the National 

Association of State Public Health 

Veterinarians has recommend washing 

hands after touching animals as a 

protection against outbreaks of E. coli 

O157:H7, Salmonella Enteritidis, 

Cryptosporidium parvum, non-O157 

STEC, Salmonella typhimurium, and 

Campylobacter jejuni (Ref. 111). 

Proposed § 112.32(b)(3) also would 

repeat some of the characteristics 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 characteristics of an 

adequate hand-washing facility because 

many of these facilities are likely to be 

in outdoor growing areas and be 

portable. Standard features that we have 

come to expect as a matter of course in 

a hand-washing facility in a building 

used for manufacturing/processing food 

may not be standard in a portable handwashing facility. Moreover, the outdoor 

nature of many areas where covered 

activities take place naturally presents 

workers with situations where they will 

get dirt on their hands, and workers may 

be routinely handling food, with their 

bare hands, that will not be cooked to 

adequately reduce pathogens. Therefore, 

we believe it is appropriate to repeat 

these requirements in the proposed 

provisions for workers to wash their 

hands as well as in the proposed 

provisions directed to hand-washing 

facilities. We seek comment on the 

hand-washing proposals described 

above. 

Proposed § 112.32(b)(4) would require 

that, if you choose to use gloves in 

handling covered produce or foodcontact surfaces, you maintain gloves in 

an intact and sanitary condition, and 

that you replace such gloves when you 

are no longer able to do so. We are not 

proposing to require the use of gloves, 

but gloves are used in many operations 

to protect workers’ hands. While gloves 

also provide a barrier that can reduce 

the potential for pathogens on workers’ 

hands to contaminate covered produce, 

gloves themselves, whether re-usable or 

disposable, can transfer pathogens to 

covered produce if the gloves become 

contaminated (Ref. 26). If gloves are 

used in handling covered produce or 

food contact surfaces, requiring that 

such gloves be either in an intact and 

sanitary condition, or else be replaced, 

reduces the potential for the gloves to be 

a source of contamination for covered 

produce. Proposed § 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 proper use 

of gloves. It has been reported that glove 

use can foster a ‘‘false sense of security’’ 

that can lead to less sanitary practices 

such as wearing the same pair of gloves 

for extended periods of time without 

cleaning them, or washing hands 

infrequently (Ref. 114). If your workers 

wear gloves, you should ensure that 

they know that wearing gloves in no 

way diminishes the importance of 

washing hands, and that gloves must be 

maintained and replaced, when 

necessary and appropriate. 

Proposed § 112.33 would require that 

you take measures to prevent visitors 

from contaminating covered produce 

and food-contact surfaces with 

microorganisms of public health 

significance. Proposed § 112.33(a) 

would define a visitor as any person 

(other than personnel) who enters your 

covered farm with your permission. 

Proposed § 112.33(b) would require that 

you make visitors aware of policies and 

procedures to protect covered produce 

and food-contact surfaces from 

contamination by people, and that you 

take all steps reasonably necessary to 

ensure that visitors comply with such 

policies and procedures. Proposed 

§ 112.33(c) would require that you make 

toilet and hand-washing facilities 

accessible to visitors. In contrast to food 

processing facilities, on-farm visitors 

often enter areas where covered produce 

is grown and harvested, particularly on 

farms that offer consumers an 

opportunity to pick their own fruits and 

vegetables. As with workers, visitors can 

transmit pathogens to covered produce 

and food-contact surfaces. Thus, we are 

proposing to require that farms address 

the potential for visitors to contaminate 

covered produce, even though we have 

no similar requirements in regulations 

such as parts 110 and 111. Proposed 

§ 112.33 is similar to provisions in our 

GAPS Guide (Ref. 10), the AFDO Model 

Code (Ref. 20), various produce industry 

guidelines (Ref. 89. Ref. 84. Ref. 99), a 

marketing agreement (Ref. 31), and the 

Codex Code (Ref. 96). A farm could 

comply with these proposed 

requirements by, for example, indicating 

the location of restrooms and handwashing facilities accessible to visitors 

and clearly posting rules applicable to 

visitors where they are likely to be seen 

and read at the beginning of a visitor’s 

visit, such as near the entrance or cash 

register at a ‘‘pick-your-own’’ farm 

operation. 

E. Subpart E—Standards Directed to 

Agricultural Water 

As proposed, subpart E discusses 

science-based minimum standards 

directed to agricultural water that are 

reasonably necessary to minimize the 

risk of serious adverse health 

consequences or death from the use of, 

or exposure to, covered produce, 

including those reasonably necessary to 

prevent the introduction of known or 

reasonably foreseeable hazards into 

covered produce, and to provide 

reasonable assurances that the produce 

is not adulterated under section 402 of 

the FD&C Act. 

1. Comments Relevant to Proposed 

Provisions 

We received some comments in 

response to the 2010 FR notice that 

addressed issues relevant to agricultural 

water. Several comments expressed 

concern that our proposed regulations 

could have an adverse effect upon or be 

in conflict with on-farm conservation or 

land management practices efforts; or 

that they could set standards for 

limiting all animal access to surface 

waters (e.g., by fencing or other barrier) 

or prohibit vegetation (normally used to 

stabilize soil or for use as a natural 

water filter) surrounding surface water 

sources. 

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In developing the provisions in 

proposed part 112, we consulted with 

USDA’s National Organic Program and 

Natural Resources Conservation Service, 

U.S. Fish and Wildlife Service, and the 

EPA (Ref. 115) to take into consideration 

conservation and environmental 

practice standards and policies 

established by those agencies. We 

recognize the importance of ensuring, to 

the extent possible, that our proposed 

provisions are compatible with existing 

conservation practices in the 

management of agricultural water 

systems. In proposed § 112.42(a)(1)–(5), 

we would require that you inspect your 

entire agricultural water system at the 

beginning of every growing season, 

focused on identifying conditions that 

are reasonably likely to introduce 

known or reasonably foreseeable 

hazards into or onto covered produce or 

food-contact surfaces. A similar 

(re)inspection would be required in 

proposed §§ 112.44(b) and (c) if the 

water you use for certain purposes does 

not meet the microbiological criteria 

described in those provisions. In each of 

these provisions, however, we do not 

describe specific inspection findings 

likely to adversely affect microbial 

water quality and relate them to specific 

required actions. For example, we do 

not propose that vegetation surrounding 

an on-farm pond be cut back and/or 

removed or that fencing must be used to 

prevent access to a pond by wildlife and 

domestic animals. We recognize that 

each farm, State, region, or produce 

commodity group may approach water 

management differently with respect to 

the likelihood of contamination of 

agricultural water and the use of 

specific conservation practices that may 

be appropriate or consistent with 

measures used to mitigate the likelihood 

of contamination. Practices used for one 

region or commodity may not be 

appropriate for others based upon 

historical experience. Under this 

proposed subpart, we would require 

that you address such issues only if they 

are reasonably likely to contribute to 

contamination of covered produce, and 

we would provide flexibility in the way 

in which you address any identified 

hazards, such that measures you 

implement to mitigate such hazards can 

be consistent with your current 

conservation practices. This approach 

allows you to put in place measures you 

deem most effective in addressing the 

potential for water contamination and to 

assess the effectiveness of those 

measures as they may be reflected in 

your microbial water quality data. 

We also received a number of 

comments expressing concern about 

costs and associated burden related to 

testing of agricultural water, including 

pathogen testing, indicators, and 

frequency of testing. As described in 

section in the QAR, pathogen presence 

and distributions in the environment 

and water systems can be expected to be 

sporadic, with survival dependent on a 

multitude of factors. Thus, broad 

generalizations concerning their 

presence or persistence in water or on 

produce are problematic, and their 

detection difficult. Therefore, rather 

than testing for the presence or levels of 

various pathogenic microorganisms, we 

propose to use a microbial indicator as 

a monitoring measure to assess the 

potential for contamination. After 

considering various microbial indicators 

of water quality (see section V.E.2. of 

this document), we tentatively conclude 

that generic Escherichia coli (E. coli) is 

best suited for this purpose. It can be 

found in at least 90 percent of all human 

and animal feces (Ref. 116) and is most 

closely associated with incidents of 

fecal contamination (Ref. 107. Ref. 108. 

Ref. 109. Ref. 110. Ref. 108. Ref. 111. 

Ref. 112). There are multiple test 

methods, commercial kits, and formats 

available at relatively low cost, and the 

accuracy, precision, and sensitivity of 

these analytical testing options would 

meet the requirements in this proposed 

rule. Although the correlation between 

generic E. coli and fecal contamination 

is strong, as discussed in section V.E.2. 

of this document, generic E. coli does 

not always reliably predict the presence 

of pathogens despite fecal pollution 

being a known source of pathogenic 

microorganisms. This is explainable, 

however, considering the current 

understanding of pathogen occurrence 

and distribution described in the QAR 

and the taxonomic diversity of 

waterborne pathogens (e.g., bacteria, 

viruses, and protists). Thus, generic E. 

coli monitoring serves as a measure to 

assess the potential for fecal 

contamination, not to directly predict 

the presence of pathogens. 

Comments also emphasized that 

microbial testing should be performed at 

a frequency dependent upon the results 

of an assessment of the risks posed by 

your agricultural water system. We 

agree that the frequency should reflect 

the risk. In proposed § 112.45(a), with 

certain exceptions, we propose to 

require you to test water used for certain 

purposes at the beginning of each 

growing season, and every three months 

thereafter during the growing season. 

We tentatively conclude that this 

frequency would provide sufficient 

information regarding the microbial 

quality of your agricultural water. We 

are proposing in addition in § 112.45(b) 

that untreated surface waters must be 

tested more frequently than ground 

water sources because surface 

watersheds are subject to a greater 

number of external forces that shape 

their overall composition, chemistry, 

and microbial water quality (e.g., 

erosion, run-off, dust, suspended 

sediments). We seek comment on our 

proposed approach. 

A number of comments related to 

quantifying risks associated with the use 

of agricultural water as a function of 

water source, time of application, 

irrigation method, and commodity type. 

Our research shows that this is an 

extremely difficult task. In the QAR, we 

considered various factors relevant to 

produce production and harvesting, 

including water sources and use (See 

the QAR document). Some conclusions 

related to likelihood of produce 

contamination associated with water 

use can be drawn, although the 

relevance of these findings and whether 

they can be generalized across 

commodities, regions, and climates is 

not known. For example, Stine et al 

(2005) (Ref. 109) and Song et al. (2006) 

(Ref. 117) provide strong evidence that 

subsurface drip irrigation lowers the 

likelihood of waterborne contamination 

compared to furrow or overhead 

irrigation. These authors also suggest 

that proximity of the edible portion 

relative to water applied and surface 

texture of the edible portion play key 

roles in likelihood of contamination. 

In addition, according to a WHO risk 

assessment (Ref. 118) of wastewater use 

in agriculture, pathogen (bacteria, 

protists, and viruses) die-off during the 

interval between last irrigation and 

consumption is approximately 1 log per 

day, although the rate varies with 

climatic conditions. Other measures that 

can be protective include cessation of 

watering, choice of irrigation method 

(localized irrigation—bubbler, drip, 

trickle is more protective than flood, 

furrow, or spray/sprinkler), and food 

preparation measures (washing) (Ref. 

118). It is difficult to determine to what 

extent this assessment can be applied to 

water systems that are not based on 

wastewater use where high pathogen 

loads can be expected. Produce grown 

with water of significantly higher water 

quality continues to be implicated in 

disease outbreaks (Ref. 119). These 

outbreaks not only illustrate the 

challenge in assigning absolute risk 

reduction values to measures used in 

the mitigation of risk, but also the 

sporadic nature of pathogen occurrence 

and localized conditions leading to the 

persistence of pathogens in the 

environment. 

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A few comments recommended that 

equipment used to hold or convey water 

should be inspected to ensure that it is 

clean. 

We agree that equipment used to hold 

or convey water should be maintained 

in a manner necessary to protect against 

contamination. In proposed 112.42(c), 

we propose to require that all 

agricultural water distribution systems 

must be adequately maintained as 

necessary and appropriate to prevent 

the water distribution system from being 

a source of contamination to covered 

produce, food-contact surfaces, areas 

used for a covered activity, or water 

sources, including by regularly 

inspecting and adequately storing all 

equipment used in the system. In 

addition, in proposed 112.42(b), we 

propose to require that all agricultural 

water sources that are under the control 

of a covered farm (such as wells) must 

be adequately maintained by regularly 

inspecting each source and keeping the 

source free of debris, trash, 

domesticated animals, and other 

possible sources of contamination of 

covered produce to the extent 

practicable and appropriate under the 

circumstances. 

We seek comment on our proposals 

and approach related to agricultural 

water. 

2. Water Quality Testing, Indicators, and 

Standards 

In this subsection, we present a 

technical discussion of issues related to 

water quality such as testing samples, 

microbial quality indicators, and 

microbial quality standards. We discuss 

these issues in greater detail in this 

subsection to further support the 

provisions proposed below related to 

water quality testing and microbial 

indicators. 

A fundamental component in 

assessing the adequacy of water for its 

intended use is a routine sampling and 

microbial testing program (Ref. 120. Ref. 

29). Water sampling and testing allows 

for informed decisions regarding the 

management of water use, such as 

choosing a water source and combining 

that selection with, for example, the 

irrigation method for a specific 

commodity or time period prior to 

harvest. Testing for microbial quality of 

water can identify possible fecal 

contamination at the water source or in 

a section of its distribution system (e.g., 

line break). Additionally, regular testing 

data may be used to identify seasonal 

(or other) trends and highlight areas of 

the system that may require attention. 

For example, regular testing results may 

show that periodic increases in 

indicator organisms are correlated with 

precipitation levels or suspended 

sediments in surface waters, providing 

useful information about when and how 

that water source can be safely used. 

Microbial water quality testing can be 

performed using a variety of methods 

that have been validated for water 

testing. A key element of any testing 

program is determining the indicator 

organism or specific pathogen(s) and the 

frequency of testing. The sensitivity of 

the method is also important, although 

most test methods available today have 

sensitivities that match or exceed 

requirements for EPA drinking water 

and FDA bottled water standards. 

Surface water quality and pathogen 

monitoring studies reported in the 

literature often quantify indicator 

organisms or pathogens on a monthly 

basis. However, most studies do not 

specifically address the impact of water 

quality on produce safety (Ref. 115. Ref. 

116. Ref. 117. Ref. 118). A lack of 

consensus among the different 

recommendations and approaches 

underscores the complexity and 

uncertainty in water quality sampling 

and testing strategies. Nevertheless, a 

vast majority of studies that address 

frequency of testing recommend that 

surface water sources should be 

sampled more frequently than ground 

water sources (Ref. 121). 

Two key determinants of an 

appropriate testing frequency emerge 

from this information: (1) Variability of 

the water source and (2) the extent to 

which it can be protected. The 

discussion above suggests that water 

obtained from a public water source is 

least likely to be a vehicle for pathogen 

contamination of produce, followed by 

water obtained from deep underground 

aquifers, shallow wells, and surface 

waters, in that order. This is consistent 

with findings reported in the literature 

(Ref. 122. Ref. 29). For purposes of 

defining likelihood of contamination, 

we further divide surface water into two 

types, based on the potential for 

contamination (through runoff), and the 

degree to which potential contamination 

can be recognized and controlled (i.e., 

(1) surface waters where runoff is 

difficult to recognize and control 

because of the size of the watershed 

(e.g., river or lake) and (2) surface waters 

where runoff can be easily detected and 

which can be managed so as to protect 

them from runoff (e.g., on-farm reservoir 

or pond)). Runoff is used here in 

differentiating the likelihood of 

contamination of surface water because 

it has the potential to carry pathogens 

and is known to mobilize pathogens 

from sediment reservoirs to the water 

column (Ref. 117. Ref. 120. Ref. 121. 

Ref. 122. Ref. 123) as well as carry 

pathogens to the surface water system 

from sources such as failing septic 

systems and deposited animal feces 

(Ref. 123. Ref. 124). 

a. Microbiological Indicators of Water 

Quality 

A primary consideration in 

establishing a microbiological water 

quality testing program is the choice of 

target organism(s). Two general 

approaches are commonly used: Test for 

the presence of an indicator organism(s) 

that may signal the presence of 

pathogens or test for pathogens 

themselves. In the United States, 

bacterial indicators have a long history 

of being used to demonstrate the safety 

of drinking water and adequacy of its 

treatment at the source. They have also 

been used to monitor the status of 

drinking water in distribution systems 

and determine if surface waters are 

microbiologically safe for recreational 

use (e.g., swimming) and shellfish 

harvest (Ref. 123). 

Bacterial fecal indicators are nonpathogenic microorganisms that are 

commonly found in the intestines of 

warm-blooded animals that are easily 

isolated and quantified as a measure of 

fecal contamination and potential for 

enteric pathogens. Desired 

characteristics for effective indicator 

organisms include: Ease of detection; 

being present only when fecal 

contamination or pathogens are present; 

and, being in numbers that correlate 

with the amount of contamination, 

numbers of pathogens and risk of 

illness. Survival times of indicator 

organisms in sediments and in water 

should be equal (or greater) to those for 

pathogens and their detection should be 

accomplished by simple, rapid methods 

at low cost. Indicator microorganisms 

are widely used in water quality testing 

because of their broad utility across 

many types of water but no single 

indicator that is universally accepted 

(Ref. 123). 

Pathogen detection has the obvious 

advantage of directly targeting 

microorganisms in water that are a risk 

to public health. However, sampling 

water for pathogens may present 

additional challenges, including larger 

sample sizes to facilitate detection, 

inherently higher costs, and the wide 

array of potential target pathogens (i.e., 

the presence or absence of one pathogen 

may not predict for the presence or 

absence of other pathogens). 

A number of indicator 

microorganisms have been used to 

predict the presence of pathogens in 

water, with varying degrees of success. 

These include total coliforms, fecal 

coliforms, enterococci, generic E. coli, 

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and coliphages. However, their presence 

does not always signal the presence of 

pathogens and the absence in their 

detection is not assurance that 

pathogens are absent (Ref. 126. Ref. 127. 

Ref. 128. Ref. 129. Ref. 130). 

Consequently, Gerba (2009) (Ref. 120) 

suggested indicators be defined by a 

purpose for which they are better suited 

instead as an indicator for pathogens. 

For example, efficacy of treatment (e.g., 

public water systems) or integrity in 

manufacturing processes (e.g., bottled 

water) can be effectively monitored by 

total coliforms because these 

environmental bacteria are not expected 

to survive the treatment conditions or be 

introduced during the manufacturing 

process. Their presence in treated 

municipal water or in bottled water may 

signal an inadequate treatment or 

deficient manufacturing step meriting 

investigation and subsequent corrective 

action to resolve the problems 

identified. Another example is using 

fecal indicator bacteria (e.g., enterococci 

or generic E. coli) to assess the risk of 

gastrointestinal illness (or other adverse 

health conditions) in marine and 

freshwater swimmers, because their 

presence is statistically correlated to 

adverse health outcomes in these groups 

(Ref. 119. Ref. 120). Generic E. coli 

alone, as an easily distinguishable 

member of the fecal coliform group, is 

more likely than the fecal coliform 

group as a whole to indicate fecal 

pollution (Ref. 120). Used in this way, 

indicator organisms are not used 

specifically to predict the presence of 

pathogens, but are useful predictors of 

undesirable conditions (e.g., ineffective 

treatment, defective manufacturing 

process, presence of fecal material). 

Total coliforms have frequently been 

used to assess water quality of several 

different types of natural waters (e.g., 

freshwater and marine) but their use for 

this purpose has decreased recently as 

they have been found to be present in 

natural water both because of fecal 

contamination and as natural 

environmental inhabitants. They are 

regularly isolated from soil, plants, 

vegetables, and effluents from 

agricultural and food industries but 

their presence does not reliably signal a 

fecal contamination event (Ref. 131. Ref. 

112). Fecal coliforms share a similar 

problem. Fecal coliforms are coliforms 

that are capable of growth at higher 

temperatures, conditions similar to 

those which can be found in the 

mammalian gut. However, some of its 

members (e.g., Klebsiella, Citrobacter, 

Enterobacter spp.) can normally be 

found outside the intestine including 

soil, water, vegetation, fresh vegetables, 

silage, insects, and many others (Ref. 

124) and there is ample evidence that 

they can grow and multiply there (Ref. 

132. Ref. 133. Ref. 114. Ref. 123). This 

makes using fecal coliforms as 

indicators for fecal contamination 

problematic, as it would be difficult to 

separate increases in their numbers due 

to natural forces (e.g., precipitation, 

erosion, wind, temperature) from 

increases due to fecal contamination 

events. 

Generic E. coli is a member of both 

the coliform and fecal coliform groups 

but has been shown to more 

consistently be associated with fecal 

contamination than other indicators 

(Ref. 134. Ref. 135. Ref. 133. Ref. 136. 

Ref. 137. Ref. 138. Ref. 112). It can be 

found in at least 90 percent of all human 

and animal feces (Ref. 108) (Ref. 116) 

where it persists, more than other 

transient fecal coliforms (Ref. 125. Ref. 

124). While its association with fecal 

contamination is very strong, it has also 

been isolated from environments with 

no apparent fecal contamination, 

including tropical watersheds (Ref. 126) 

and paper mill effluents (Ref. 127). 

Outside of these findings, reports of 

generic E. coli growth and proliferation 

outside the gut (e.g., in water) are 

generally rare. Generic E. coli 

demonstrates variable survival times in 

water but may only persist from 4 to 12 

weeks at 15–18 degrees Celsius (Ref. 

116). 

Generic E. coli has an extensive 

history of use as an indicator of fecal 

contamination and is considered the 

best indicator for monitoring water 

quality (Ref. 119). Its detection and 

enumeration can be performed using a 

variety of commercial products at 

relatively low cost. However, its ability 

to signal fecal contamination events is 

dependent upon sampling frequency 

and location relative to the source of 

contamination. Thus, instances of nondetection are not considered 

confirmation of the absence of fecal 

contamination because sampling 

frequency may not be adequate to detect 

events occurring over short periods of 

time. Sampling results can only be 

considered snapshots of water quality 

over time. Moreover, the fate and 

transport of generic E. coli in 

watersheds may be different than other 

fecal constituents in response to 

localized conditions (e.g., sunlight, 

temperature) (Ref. 128. Ref. 129. Ref. 

130). 

One challenge in using indicator 

organisms to predict water quality is 

correlating information concerning their 

numbers to the presence or absence of 

pathogens (as compared to the presence 

or absence of fecal material). Although 

generic E. coli is recognized as a good 

indicator of fecal contamination, 

pathogens are not always present in that 

fecal material because their distribution 

and persistence is sporadic. As a 

consequence, the record of generic E. 

coli as a predictor of pathogens is 

mixed. The Canadian FederalProvincial-Territorial Committee on 

Drinking Water states generic E. coli is 

unsatisfactory in predicting the 

presence of Giardia, Cryptosporidium, 

and enteric viruses (Ref. 119. Ref. 124) 

and Horman et al. 2004 (Ref. 131) found 

poor correlation between generic E. coli 

and the presence of pathogens 

(Campylobacter spp., Giardia spp., 

Cryptosporidium spp., and noroviruses) 

in Finnish surface waters. However, 

they did conclude that the absence of 

generic E. coli was a very strong 

predictor for the absence of pathogens. 

Duris et al (2009) (Ref. 132) found 

generic E. coli inconsistently correlated 

to genetic markers for generic E. coli 

O157 in Michigan and Indiana river 

water but suggested the relationship 

could be strengthened by increased 

sample size. Alternately, Wilkes et al., 

2009 (Ref. 133) reported generic E. coli 

concentrations were the best indicator 

of pathogens (E. coli O157:H7, 

Salmonella spp., Campylobacter spp, 

Giardia and Cryptosporidium) presence/ 

absence in Canadian watersheds. Others 

have noted that generic E. coli has a 

better record as an indicator for 

Salmonella than for E. coli O157:H7 

(Ref. 134). Review of these studies 

illustrates the complexity of possible 

interactions between indicators and 

pathogens in water, and their potential 

for separate fates within those systems. 

Studies relating indicators, pathogens, 

and the risks associated with produce 

consumption are few and are 

complicated by the relationships 

described above. Different survival 

profiles between indicators and 

pathogens on produce may also affect 

risk. The World Heath Organization 

(Ref. 118) proposed a set of pathogen 

reduction measures that can be used 

alone or in combination to achieve a 6– 

7 log pathogen reduction they 

determined necessary to meet healthbased targets. To verify the effectiveness 

of the measures, they recommend 

monitoring generic E. coli levels in 

treatment effluents and in crops at 

harvest. They noted that field pathogen 

die-off is variable (0.5–2 log per day), 

dependent on temperature, sunlight, 

crop type, time, and other factors. 

Produce contamination events that 

occur during growing, harvesting, 

packing, or holding on farm are 

generally thought to occur 

intermittently and at low doses. As a 

result, the detection of human 

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pathogens in contaminated produce 

using available testing methodologies 

remains an arduous process. It is 

impractical to test 100% of the product; 

therefore sampling plans to collect a 

statistically significant subset must be 

devised. Unfortunately, although such 

testing has in the past prevented some 

contaminated product from entering the 

market when pathogens are found, it is 

also very possible that testing can 

entirely miss a point contamination, 

thus it cannot provide a litmus test for 

food safety because the sample size 

needed to detect low dose, low 

frequency, and non-uniformly 

distributed contamination is 

impractically large (Ref. 135). In 

addition, microbial testing can only 

detect the pathogens the analytical 

procedures are designed to detect, and 

we tend to only test for pathogens 

known to be of concern. Considering the 

range of potential pathogens, these are 

significant limitations. 

b. Microbial Water Quality Standards 

The lack of sufficient information to 

support a pathogen-based 

microbiological standard for water used 

in the production of produce has led to 

the adoption of the generic E. coli 

component of the U.S. EPA recreational 

water standards (for frequently used 

beaches) by some industry groups (Ref. 

44. Ref. 31). The EPA recreational water 

standards were developed from 

epidemiological studies that correlated 

the risk of gastrointestinal illness to 

exposure to marine and freshwater by 

swimmers (Ref. 136). Generic E. coli was 

found to be a good predictor of 

swimming associated illness in 

freshwater and the EPA recommended 

criteria include a geometric mean of 126 

CFU per 100 ml and a single sample 

maximum for designated beach areas of 

235 CFU per 100 ml (Ref. 136). British 

Columbia, Canada has announced their 

intention to use a similar approach in 

setting generic E. coli criteria for 

irrigation water used on produce 

consumed raw. Their irrigation criteria 

(less than or equal to 77 CFU per 100 

ml geometric mean) are the same as and 

were derived from those used for 

primary-contact recreation (Ref. 137). 

See section V.E. of this document for 

additional discussion of this issue. 

The U.S. EPA criteria were developed 

from epidemiological studies of beach 

areas subject to point source fecal 

contamination rather than non-point 

source contamination (e.g., birds, 

agricultural and livestock runoff). Nonpoint sources may also influence the 

quality of agricultural water. Further, 

adverse health outcomes as a 

consequence of immersion while 

swimming in contaminated water may 

be different from those as a result of 

eating produce irrigated with 

contaminated water. The routes of 

infection and pathogen mortality rates 

are different in each environment. 

Based upon a WHO analysis of 

tolerable risk for irrigation water, the 

minimum microbial quality for water 

used on root crops that are eaten raw is 

1,000 CFU generic E. coli per 100 ml 

(10,000 CFU generic E. coli per 100 ml 

in leaf crops) (Ref. 120. Ref. 118). 

According to the WHO analysis, using 

water of this microbial quality is 

dependent upon a 2 log reduction due 

to die-off between last irrigation and 

consumption (includes die-off in the 

field and during distribution) and a 1 

log reduction attributed to washing 

prior to consumption. This analysis 

recognizes the variable nature of die-off 

values, ranging from 0.5–2.0 log per day 

(Ref. 118). The WHO analysis considers 

the need for a four log reduction 

through dilution, die-off, or treatment 

between the levels of generic E.coli in 

raw sewage (well represented in sewage 

by fecal coliform levels) and the levels 

in irrigation water used on root crops 

that are eaten raw (3 log for leaf crops), 

in addition to the 3 log reduction 

discussed above. 

3. Proposed Requirements 

a. General Requirement 

Proposed § 112.41 would establish the 

requirement that all agricultural water 

must be safe and of adequate sanitary 

quality for its intended use. The 

principle of ‘‘safe and of adequate 

sanitary quality for its intended use’’ 

contains elements related both to the 

quality of the source water used and the 

activity, practice, or use of the water. 

Uses vary significantly, including: Crop 

irrigation (using various direct water 

application methods); crop protection 

sprays; produce cooling water; dump 

tank water; water used to clean packing 

materials, equipment, tools and 

buildings; and hand washing water. The 

way in which water is used for different 

commodities and agricultural practices 

can determine how effectively 

pathogens that may be present are 

transmitted to produce. 

Comparing the probability of 

contamination of covered produce 

associated with key practices at 

different stages of production and across 

a range of commodities, the 

interrelatedness of these factors 

becomes apparent. The QAR shows that 

the likelihood of contamination 

associated with indirect water use for 

irrigation is relatively low compared to 

irrigation water that directly contacts 

produce (Ref. 2). Therefore, in Section 

V.A.2.b (Definitions), we propose to 

define ‘‘agricultural water’’ to mean 

water used in covered activities on 

covered produce, where water is 

intended to, or is likely to, contact 

covered produce or food-contact 

surfaces, including water used in 

growing activities (including irrigation 

water applied using direct water 

application methods, water used for 

preparing crop sprays, and water used 

for growing sprouts) and in harvesting, 

packing, and holding activities 

(including water used for washing or 

cooling harvested produce and water 

used for preventing dehydration of 

covered produce). As we propose in 

§ 112.3(c), ‘‘covered produce’’ refers to 

the harvestable or harvested portion of 

the crop. As proposed, ‘‘agricultural 

water’’ does not include indirect water 

application methods used during 

growing. For example, generally, the 

water used for drip or furrow irrigation 

in apple orchards would not be 

considered agricultural water because 

the water is unlikely to contact the 

harvestable portion of the crop. As 

another example, generally, the water 

used for overhead spray irrigation of 

romaine lettuce would be considered 

agricultural water because the water is 

likely to contact the harvestable portion 

of the crop. We are proposing to 

distinguish between water that is 

intended to, or is likely to, contact 

covered produce or food-contact 

surfaces (e.g., direct water application 

method irrigation water) and water that 

is not intended to, or is not likely to, 

contact covered produce or food-contact 

surfaces based on the relative likelihood 

of contamination from water that 

contacts covered produce and the need 

for measures to minimize such 

likelihood. 

If finalized as proposed, indirect 

water application methods would not be 

subject to the requirements of this rule. 

While indirectly applied water is 

unlikely to contact produce or foodcontact surfaces, we recognize that it 

presents the possibility of produce 

contamination. For example, use of 

contaminated water in drip or furrow 

irrigation may still serve as a vehicle for 

bringing contaminants into the growing 

environment which may potentially be 

transferred to produce by rain splash, 

workers, or equipment; use of 

contaminated water for dust abatement 

on farm roads may also be transferred to 

produce by run-off, rain splash, 

workers, or equipment. 

Indirect water application methods 

would remain subject to Section 

402(a)(4) of the FD&C Act. That is, 

indirect water application may 

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adulterate produce if, considering the 

water quality and the manner of its 

application, the use of the water causes 

produce to be prepared, packed, or held 

under insanitary conditions whereby it 

may have been contaminated with filth 

or rendered injurious to health. 

Moreover, if a pathogen is detected in or 

on produce, such produce would be 

considered adulterated under Sections 

402(a)(1) of the FD&C Act, in that it 

contains a poisonous or deleterious 

substance which may render it injurious 

to health. Therefore, we tentatively 

conclude that indirect water application 

methods do not need to be covered 

within the scope of ‘‘agricultural water’’ 

for the purposes of this rule. 

We ask for comment on the limited 

scope of ‘‘agricultural water’’ to only 

water that is intended to, or likely to 

contact covered produce or food-contact 

surfaces. We also seek comment on its 

resulting effect on the applicability of 

the general requirement in proposed 

§ 112.41 that agricultural water must be 

safe and of adequate sanitary quality for 

its intended use, to only water that is 

intended to, or likely to, contact covered 

produce or food-contact surfaces. Water 

that is not safe or of adequate sanitary 

quality for its intended use may lead to 

contamination of covered produce, even 

where the water use is indirect. We have 

previously recommended measures 

such as indirect water use when water 

quality is poor or unknown as a measure 

to minimize risk (Ref GAPs Guide). 

Considering the FD&C Act would still 

apply to such uses, and that there is a 

lower likelihood of contamination of 

produce by indirect water use, is there 

a need to subject indirect water use, 

including water used for dust 

abatement, to the general requirement in 

proposed § 112.41? We welcome 

comment on this approach, as well as 

other actions that have been found to be 

effective through practice and 

experience. 

We also considered proposing some 

requirements for water that is used 

during growing, but which does not 

contact the harvestable portion of 

covered produce. For example, water 

that did not contact produce would not 

have been subject to any testing 

requirement, although we considered 

requiring this water and all agricultural 

water to be of safe and adequate sanitary 

quality for its intended use (proposed 

§ 112.41). We also considered requiring 

indirect water to comply with proposed 

§ 112.42(a) (sanitary survey) and 

§ 112.42(b) through (d) (adequately 

maintaining water sources under your 

control). If we did include both direct 

and indirect water use in the definition 

of ‘‘agricultural water’’ in the final rule, 

which of the proposed requirements for 

agricultural water described in section 

V.E. of this document would (or would 

not) be appropriate for indirect water 

use? Are there other factors that we 

should consider? In every application of 

water, careful consideration should be 

given to what you know about the 

water’s quality at its source, the impact 

your distribution system may have on 

the water quality, and when or how that 

water is to be used. For example, water 

that contains Salmonella would not be 

safe or of adequate sanitary quality for 

its intended use when used in a 

postharvest dump tank for tomatoes. 

Salmonella is a food safety hazard that 

is well-documented to present a risk of 

severe adverse health consequences or 

death, and tomatoes can become 

contaminated by water containing 

Salmonella (Ref. 138. Ref. 139. Ref. 

140). As another example, when the 

surface water (e.g., river) that you use 

for crop irrigation using a direct 

application method has a noticeable 

decrease in quality due to an upstream 

event like the failure of a waste water 

treatment plant, resulting in the 

accidental discharge of untreated 

municipal sewage into the river, your 

water source would not be safe or of 

adequate sanitary quality for its 

intended use until the discharge is over 

and the water has been tested because 

the incompletely treated sewage in the 

discharge is likely to contain pathogenic 

microorganisms that could compromise 

the safety of irrigated covered produce. 

The most frequently used irrigation 

methods include overhead, surface and 

subsurface drip, furrow, flood, and seep 

irrigation (Ref. 29). These practices may 

be commodity-specific and choices may 

be limited by the availability of different 

water sources, crop needs, climate, 

precipitation levels, or regional 

practices. Each irrigation method 

presents a different likelihood of 

contamination, independent of the 

water source and its application to a 

particular commodity. For example, the 

likelihood of produce contamination 

may be reduced if irrigation water is 

delivered by subsurface drip irrigation 

compared to using the same water to 

irrigate by overhead spray (Ref. 141. Ref. 

122). Researchers also concluded that 

both the physical properties of the 

edible portion of the crop, such as 

surface texture, and the location of the 

edible portion of the plant in relation to 

irrigation water played significant roles 

in contamination (Ref. 130). As 

discussed in the QAR, the timing of 

irrigation water application also plays a 

role in minimizing the persistence of 

contamination. For example, water 

containing elevated generic E. coli used 

in overhead irrigation shortly before 

harvest may increase the likelihood of 

covered produce being contaminated 

with the pathogen at harvest, but the 

same water could safely be used to 

establish a crop and throughout the 

majority of the growing season because, 

as discussed in the QAR, pathogens dieoff over time on the surface of produce. 

Water used for washing hands during 

and after harvest, sprout irrigation, 

directly contacting produce during or 

after harvest (such as in washing and 

cooling, or to make ice that directly 

contacts produce), making treated 

agricultural tea, and water or ice that 

will contact food contact surfaces that 

contact covered produce presents an 

even greater likelihood of microbial 

contamination of covered produce (Ref. 

131. Ref. 132). Waterborne pathogens 

can be transferred to covered produce 

with little opportunity for die-off if 

contaminated water is used for hand 

washing during or after harvest, or in 

harvest, packing or holding activities 

where it directly contacts produce or 

surfaces that contact produce and, 

therefore, it is important to ensure that 

the water is safe and of adequate 

sanitary quality for such uses. Moreover, 

the high nutrient, high moisture 

conditions inherent to sprout 

production and agricultural teas not 

only support pathogen survival but are 

also conducive to their amplification if 

present (Ref. 142. Ref. 16). Again, the 

selection of a water source for these uses 

must ensure that the water is safe and 

of adequate sanitary quality for that use. 

b. Measures Regarding Agricultural 

Water Sources and Distribution Systems 

Proposed § 112.42 would establish the 

measures that you must take with 

respect to agricultural water sources, 

water distribution 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, practices, and 

conditions, including consideration of 

the following: 

(1) The nature of each agricultural 

water source (for example, ground water 

or surface water); 

(2) The extent of your control over 

each agricultural water source; 

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(3) The degree of protection of each 

agricultural water source; 

(4) Use of adjacent or nearby land; 

and 

(5) The likelihood of introduction of 

known or reasonably foreseeable 

hazards to agricultural water by another 

user of agricultural water before the 

water reaches your covered farm. 

Human pathogens can enter an 

agricultural water system anywhere 

from its source to point of use. Central 

to the prevention of pathogen 

contamination of agricultural water is 

an inspection of water source and the 

components of the distribution system 

to identify potential routes of 

contamination. Inspections of water 

sources and components of its 

distribution system are recommended 

by government and industry references 

(Ref. 10. Ref. 20. Ref. 45. Ref. 44). 

Generally, inspection of the 

agricultural water system under your 

control beginning at the water system 

source is the first opportunity for 

ensuring that it will deliver water that 

is safe and of adequate sanitary quality 

for its intended use. Inspection of your 

water source provides an opportunity to 

identify and characterize activities and 

situations that may lead to 

contamination of your agricultural 

water. Further, inspection results 

provide you with historical knowledge 

of your water sources, their quality, and 

factors that may affect their quality (Ref. 

31). Inspection of the water source and 

any equipment used to obtain the water 

from the source (e.g., well head, pumps, 

pipes) can ensure that the water that 

enters the distribution system is suitable 

for its intended use. 

Proposed § 112.42(a)(1) requires you 

to consider the nature of your 

agricultural water sources to identify 

conditions that are reasonably likely to 

introduce known or reasonably 

foreseeable hazards into or onto covered 

produce or food-contact surfaces. As 

discussed in the QAR, ground water 

which is often believed to be pathogen 

free can be contaminated. Ground water 

can also be compromised and its water 

quality degraded if wells are improperly 

constructed, poorly maintained, or 

improperly located (e.g., near areas of 

extensive livestock production or fields 

where manure is applied (Ref. 143. Ref. 

144. Ref. 122). U.S. water systems using 

ground water as source waters for 

drinking must operate in compliance 

with the U.S. EPA Ground water Rule 

(GWR) (40 CFR parts 141 and 142) to 

protect against illness from waterborne 

pathogens in ground water. However, 

the GWR does not address private wells 

because they are not under the 

jurisdiction of the Safe Drinking Water 

Act and are therefore not subject to EPA 

regulation. Thus, water quality and 

survey data on ground water used for 

agriculture are not publicly available. 

By their nature, surface waters are open 

systems, subject to the influence of 

various environmental factors that can 

impact the safety of the water. For 

example, increased precipitation levels, 

storm events, or wind may result in a 

spike in water turbidity, due to 

redistribution of sediments. We 

tentatively conclude that there exists 

significant potential for contamination 

of ground and surface waters and, 

therefore, we propose to require you to 

include both ground and surface water 

sources in your inspection of your 

agricultural water systems. We seek 

comment on this tentative conclusion 

and associated proposals. 

Proposed § 112.42(a)(2) requires you 

to consider the extent to which you 

have control over your agricultural 

water source to identify conditions that 

are reasonably likely to introduce 

known or reasonably foreseeable 

hazards into or onto covered produce or 

food-contact surfaces. You may have 

more control over your ground water 

source (well) if it draws water from an 

aquifer beneath your property and 

which you protect from the influence of 

surface activities. You would likely 

have less control if your well is located 

near a concentrated animal feeding 

operation or is influenced by surface 

water (e.g., a shallow well). You may 

have greater access to and control of onfarm surface water sources such as 

impoundments, catches, and ponds, 

than you would for flowing surface 

waters that only course through but do 

not originate on your land. 

Proposed § 112.42(a)(3) requires you 

to consider the degree of protection of 

each agricultural water source. 

Examples of protection for water 

sources include covers, containments, 

or fencing that exclude domesticated 

animals or other possible sources of 

contamination from the water source or 

earthen berms or other barriers that help 

minimize the influence of runoff on the 

water source. 

Proposed § 112.42(a)(4) requires you 

to consider the use of adjacent or nearby 

land. Agricultural water may be affected 

by upstream agricultural practices and 

runoff from those operations into 

surface water sources that you use. For 

example, an upstream alfalfa grower 

may apply raw manure as a soil 

amendment, and irrigation water runoff 

from that field may flow into your 

agricultural surface water source. While 

you may have little or no control of 

other agricultural water user practices, 

this proposed requirement to consider 

those nearby uses of which you are 

aware will help you determine 

appropriate and safe use of that water 

source. 

Proposed § 112.42(a)(5) requires you 

to consider the likelihood of 

introduction of known or reasonably 

foreseeable hazards to agricultural water 

by another user of agricultural water 

before the water reaches your covered 

farm. For example, if you use water 

from a river and are downstream from 

a waste water treatment plant that 

discharges into that river, this provision 

would require you to consider the 

likelihood that the wastewater treatment 

plant introduces hazards into the water 

before it reaches your farm. For 

example, you would consider the 

likelihood of accidental discharge of 

untreated municipal sewage into the 

river. 

Proposed § 112.42(b) would require 

that you adequately maintain all 

agricultural water sources that are under 

your control (such as wells) by regularly 

inspecting each source and keeping the 

source free debris, trash, domesticated 

animals, and other possible sources of 

contamination of covered produce to the 

extent practicable and appropriate 

under the circumstances. Regular 

maintenance of your water sources is 

imperative to ensure the continued 

safety of your water. Maintenance of onfarm water sources may include upkeep 

and repair of berms, pipes, liners, or any 

structural elements, that are used to 

protect the source. Properly maintaining 

a well includes conducting wellhead 

inspections, during which time you 

check the condition of the well 

covering, casing, and cap to make sure 

all are in good repair, leaving no cracks 

or other entry points for potential 

contaminants. Properly maintaining a 

storage tank includes cleaning the 

interior surfaces of all rust scale, paint 

scale, dirt, and bio-film forming growths 

and inspecting exterior surfaces for 

corrosion which may become a route of 

contamination (Ref. 31). Properly 

maintaining a farm pond that is used for 

irrigation using a direct application 

method, with respect to keeping it free 

from domesticated animals, could mean 

fencing the pond if you keep 

domesticated animals in the area such 

that they would otherwise have access 

to the pond. On the other hand, if you 

treat the water before use in this way, 

you may not need to take steps to 

prevent access of the domesticated 

animals to the pond. This proposed 

provision should not be construed to 

require the ‘‘taking’’ of an endangered 

species, as the term is defined in the 

Endangered Species Act (16 U.S.C. 

1532(19)) (i.e., to harass, harm, pursue, 

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3566 Federal Register / Vol. 78, No. 11 / Wednesday, January 16, 2013 / Proposed Rules 

hunt, shoot, wound, kill, trap, capture, 

or collect, or to attempt to engage in any 

such conduct). 

Proposed § 112.42(c) would require 

that you adequately maintain all 

agricultural water distribution systems 

as necessary and appropriate to prevent 

the water distribution system from being 

a source of contamination to covered 

produce, food-contact surfaces, areas 

used for a covered activity, or water 

sources, including by regularly 

inspecting and adequately storing all 

equipment used in the system. Regular 

maintenance of your agricultural water 

distribution system can be performed in 

conjunction with inspections and 

cleaning, as applicable. If not regularly 

maintained, portions of a water 

distribution system may fail, corrode, 

collect debris, or otherwise become a 

source of contamination. For 

agricultural water distribution system 

components that are underground, it 

would be important to look for signs of 

erosion or wet soil areas, as they may 

indicate a damaged underground 

component requiring further inspection 

and maintenance (Ref. 145). 

Proposed § 112.42(d) would establish 

that you must immediately discontinue 

use of a source of agricultural water 

and/or its distribution system, and not 

use the water source and/or its 

distribution system when you have 

determined or have reason to believe 

that your agricultural water is not safe 

and of adequate sanitary quality for its 

intended use, until you either: (1) Reinspect the entire agricultural water 

system under your control, identify any 

conditions that are reasonably likely to 

introduce known or reasonably 

foreseeable hazards into or onto covered 

produce or food-contact surfaces, make 

necessary changes, and test the water to 

determine if your changes were effective 

and to ensure that your agricultural 

water is safe and of adequate sanitary 

quality for its intended use; or (2) treat 

the water in accordance with the 

requirements of § 112.43. Using 

agricultural water that is not safe or of 

adequate sanitary quality for its 

intended use may lead to contamination 

of covered produce. Lapses in sanitary 

quality of water can occur in any 

segment of a water system, from source 

to point of use. For example, if you find 

that water contains Salmonella at the 

point where it would be used in a dump 

tank for tomatoes, it would not be safe 

or of adequate sanitary quality for that 

intended use. As another example, your 

water would not be considered safe or 

of adequate sanitary quality for its 

intended use if you found detectable 

generic E. coli in a 100 ml water sample 

you obtained at the point where the 

agricultural water is used for washing 

produce as described in proposed 

§ 112.44(a). Similarly, your water would 

not be considered safe or of adequate 

sanitary quality if you found that test 

results exceeded 235 CFU per 100 ml 

generic E. coli in a water sample you 

obtained from water used to overhead 

irrigate lettuce (a direct application 

method) as provided in proposed 

§ 112.44(c). We seek comment on these 

proposed thresholds. 

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 conditions you currently 

observe. You would identify changes 

likely to have an impact on the quality 

of water (e.g., evidence of runoff, animal 

intrusion, suspended sedimentation, 

changes in adjacent land use) or any 

lapses in your procedures (e.g., outdated 

well inspection, break in the water 

treatment schedule). You would test the 

water after you make changes you find 

necessary during your inspection. 

Under the proposed provision in 

§ 112.42(d)(2), you could instead choose 

to treat your water in accordance with 

the requirements of § 112.43 to ensure 

its safety. We tentatively 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 agricultural water does not 

serve as a source of contamination to 

covered produce. We welcome comment 

on this approach, as well as other 

actions that have been found to be 

effective through practice and 

experience. 

Proposed § 112.42(e) would establish 

that, as necessary and appropriate, you 

must implement measures reasonably 

necessary to reduce the potential for 

contamination of covered produce with 

known or reasonably foreseeable 

hazards as a result of pooling of water. 

For example, such measures may 

include using protective barriers or 

staking to keep covered produce from 

touching the ground, or using an 

alternative irrigation method. Pooling 

may occur if excessive water is applied 

to a crop, especially in areas of poor 

drainage. Pooled water that remains for 

extended periods of time has been 

shown to increase likelihood of 

contamination (Ref. 10. Ref. 45). 

Further, if pooled water is in close 

proximity to the crop, it may serve as an 

attractant for pests. Mounding soil, 

staking, subsoil drip irrigation, drip tape 

or plasticulture (use of agricultural 

plastics) are methods that are used to 

reduce the potential for pooling or to 

separate the pooled water from the 

covered produce. We acknowledge the 

potential for small pools of water to 

temporarily form in field areas or at the 

base of plants after irrigation. Small 

amounts of water of this nature, which 

are temporary and occur in the normal 

course of irrigation practices, are not 

reasonably likely to contribute to the 

contamination of covered produce. We 

are not suggesting that it will always be 

possible to eliminate pooling. Avoiding 

pooling by careful control of irrigation 

is ideal; however, events such as rainfall 

or irrigation malfunction may 

sometimes make pooling inevitable. In 

those cases, the proposed requirement 

would require farms to take steps to 

protect covered produce from 

contamination that may build in the 

pooled water. 

c. Requirements for Treating 

Agricultural Water 

Water treatment is an effective means 

of decreasing the number of waterborne 

outbreaks in sources of drinking water 

(Ref. 146). However, treatments that are 

inadequate or improperly applied, 

interrupted, or intermittent have been 

associated with waterborne disease 

outbreaks (Ref. 146). Failures in 

treatment systems are largely attributed 

to suboptimal particle removal and 

treatment malfunction (Ref. 147). For 

this reason, when treating water, it is 

important to monitor the treatment 

parameters to ensure the treatment is 

delivered in an efficacious manner. 

Monitoring treatment can be performed 

in lieu of microbial water quality 

monitoring, if under the intended 

conditions of the treatment, the water is 

rendered safe and of adequate sanitary 

quality for its intended use. Many 

operations choose to perform microbial 

water quality testing in addition to 

monitoring the water treatment as a 

further assurance of treatment 

effectiveness (Ref. 148). 

Proposed § 112.43 would establish 

requirements related to treatment of 

agricultural water. Specifically, 

proposed § 112.43(a) would require that 

you must treat any agricultural water 

that you use (such as with an EPAregistered antimicrobial pesticide 

product) if you know or have reason to 

believe that the water is not safe and of 

adequate sanitary quality for its 

intended use, whereas proposed 

§ 112.43(b) would 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 treatment 

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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) monitor any 

treatment of agricultural water at a 

frequency adequate to ensure that the 

treated water is consistently safe and of 

adequate sanitary quality for its 

intended use. 

If you choose to use water that is not 

safe or of adequate sanitary quality for 

its intended use, the water must be 

treated before it is put to such use to 

minimize the likelihood for 

contamination. For example, treating 

agricultural water with antimicrobial 

compounds can be an effective means to 

eliminate pathogens if done properly, 

including under conditions that ensure 

the effectiveness of the active ingredient 

(Ref. 149. Ref. 150). Any chemicals used 

in the treatment of water would require 

EPA registration under the Federal 

Insecticide, Fungicide and Rodenticide 

Act before they can be lawfully used. 

We note, however, that at the present 

time, no such registration for chemical 

treatment of irrigation water exists. We 

anticipate that the proposed delayed 

implementation period for water quality 

testing (see section IV.K. of the 

document) would provide industry 

adequate time to address such issues. 

We seek comment on this issue. 

To ensure water treatment is 

delivered in an effective manner, 

monitoring the conditions of treatment 

is also essential. An effective monitoring 

program would measure the level of 

active compound as well as those 

factors that may affect its activity, such 

as pH, temperature, and contact time. 

For example, monitoring water treated 

with hypochlorite in an orange 

postharvest wash would include, at a 

minimum, monitoring the level of active 

antimicrobial (free available chlorine) 

and pH, since it is known that 

hypochlorite activity is reduced both by 

organic material (e.g., soil, plant debris) 

and pH values outside its effective range 

(pH 6.0–7.5) (Ref. 149. Ref. 150). The 

concentration of active disinfectant and 

pH must be adjusted, as necessary, 

taking into account variations in water 

quality in order to maintain the 

effectiveness of the treatment. In 

addition, the frequency in which you 

monitor agricultural water treatment 

must be adequate to ensure that the 

conditions for proper treatment are 

consistently met and adjusted, as 

necessary, to result in water that is safe 

and adequate for its intended use. 

Research has shown that in other 

settings, monitoring of physical 

parameters, such as temperature, pH 

and disinfectant concentration, can be 

done in real-time and in an inexpensive, 

automated manner, facilitating good 

control of the process (Ref. 149). As a 

verification that the treatment process, 

monitored in accordance with the 

proposed requirements of § 112.43(c)(2), 

is effective in achieving a certain 

microbial standard (e.g., no detectable 

generic E. coli in 100 ml of water), you 

may chose to perform periodic 

microbiological analysis of the treated 

agricultural water. We are not proposing 

at this time that treated water must be 

tested in this manner because we 

believe that the effectiveness of various 

treatment processes is well understood. 

However, we encourage farms to 

perform such testing to provide further 

assurance of the effectiveness of their 

treatment under the specific conditions 

that exist on their farm. We seek 

comment on this issue. 

d. Testing and Frequency of Testing of 

Agricultural Water 

Proposed § 112.44 would establish 

requirements related to testing of 

agricultural water and subsequent 

actions based on the test results. 

Specifically, proposed § 112.44(a) 

would require that you 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 to ensure there is no detectable 

generic E. coli in 100 ml agricultural 

water when it is: 

(1) Used as sprout irrigation water; 

(2) Applied in any manner that 

directly contacts covered produce 

during or after harvest activities (for 

example, water that is applied to 

covered produce for washing or cooling 

activities, and water that is applied to 

harvested crops to prevent dehydration 

before cooling), including when used to 

make ice that directly contacts covered 

produce during or after harvest 

activities; 

(3) Used to make a treated agricultural 

tea; 

(4) Used to contact food-contact 

surfaces, or to make ice that will contact 

food-contact surfaces; or 

(5) Used for washing hands during 

and after harvest activities. 

We seek comment on the 

appropriateness of these proposed 

categories in which testing would be 

required. 

Proposed § 112.44(b) would require 

that if you find that there is any 

detectable generic E. coli in 100 ml of 

water, you must immediately 

discontinue use of that source of 

agricultural water and/or its distribution 

system for the uses described in 

§ 112.44(a). Before you may use the 

water source and/or distribution system 

again for the uses described in 

§ 112.44(a), you must either re-inspect 

the entire agricultural water system 

under your control, identify any 

conditions that are reasonably likely to 

introduce known or reasonably 

foreseeable hazards into or onto covered 

produce or food-contact surfaces, make 

necessary changes, and retest the water 

to determine if your changes were 

effective and to ensure that the water 

meets the requirements of § 112.44(a); or 

treat the water in accordance with the 

requirements of § 112.43. 

We reviewed the most widely used 

indicator(s) or indicator groups for their 

potential in assessing the microbial 

quality of water used for purposes 

described in proposed § 112.44(a) and 

all other uses of agricultural water as 

described in section V.E.2 of this 

document. We considered total 

coliforms and fecal coliforms as 

indicators of fecal contamination but 

determined that neither of them can 

serve as reliable indicators of a fecal 

contamination event (Ref. 124. Ref. 119. 

Ref. 151. Ref. 152). Generic E. coli is a 

member of both the coliform and fecal 

coliform groups but, unlike some 

members of those groups, it has been 

shown using various detection methods 

to be the only coliform consistently 

associated with fecal contamination 

(Ref. 132. Ref. 133. Ref. 134. Ref. 135. 

Ref. 136. Ref. 137. Ref. 108). Generic E. 

coli has an extensive history and 

support for use as an indicator of fecal 

contamination. Recently, it has emerged 

as the preferred indicator for monitoring 

water quality, not only because of the 

problems with other groups noted 

above, but also due to the development 

of superior methods of detection with 

greater accuracy, sensitivity, and 

simplicity over those previously used 

(Ref. 119). Despite widespread use and 

support for generic E. coli as an 

indicator of fecal contamination, its 

ability to signal contamination events is 

not without challenges. Sampling 

frequency and location relative to the 

source of contamination are reported to 

affect the performance of generic E. coli 

as an indicator of fecal contamination 

(Ref. 133. Ref. 143. Ref. 153. Ref. 131). 

Thus, non-detection cannot be 

considered absolute confirmation that 

fecal contamination has not occurred. 

Further, the fate and transport of generic 

E. coli takes different paths in different 

watersheds, and reservoirs have been 

identified, particularly sediments, 

where they may escape detection in the 

water column (Ref. 128. Ref. 129. Ref. 

130. Ref. 154). Nevertheless, based on 

our review of the literature, we 

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tentatively conclude that generic E. coli 

serves as the most appropriate microbial 

indicator of fecal contamination of 

water at this time and, therefore, we 

propose to use a microbial standard of 

no detectable generic E. coli in 100 ml 

agricultural water when it is for the 

intended uses listed in § 112.44(a). We 

seek comment on our selection of this 

indicator. 

As discussed in the QAR, water used 

for the purposes listed in proposed 

§ 112.44(a) has the potential to serve as 

a vehicle of pathogen contamination by 

direct contact with covered produce. 

Water used in sprout production must 

be free of fecal contamination because 

the conditions under which sprouted 

seeds are produced (warm, moist, 

nutrient-rich environment for extended 

period of time) are conducive to 

pathogen multiplication (Ref. 14). As 

discussed in section I.A. of this 

document, outbreaks associated with 

sprouted seeds are well documented; 

Salmonella and E. coli O157:H7 have 

been the major causes of sproutassociated outbreaks (Ref. 14). Similarly, 

the conditions under which agricultural 

tea is produced (moist and nutrientrich) are similar in that they support the 

multiplication of pathogens, if present 

(Ref. 142). Even a low number of 

pathogens introduced into or onto 

covered produce through contaminated 

water could rapidly increase to levels 

that could present risk of serious 

adverse health consequences or death to 

those who consume the covered 

produce for which the tea was used. 

Further, water that is used in direct 

contact with produce or food contact 

surfaces, or in making ice that directly 

contacts produce or food contact 

surfaces, must also be free of fecal 

contamination and pathogens. These 

water applications normally occur 

during or shortly after harvest, leaving 

only a relatively short period of time 

before consumption for the 

environmental factors that drive 

pathogen die-off to exercise a significant 

effect (see the QAR). In addition, we 

propose to apply the microbial standard 

in proposed § 112.44(a) to agricultural 

water that is intended for use in 

washing hands during harvesting, 

packing, and holding activities, where 

there is little opportunity for microbial 

die-off prior to consumption. Hands that 

contact produce during and after harvest 

must be free of microbial contaminants 

(Ref. 133). In the United States, the 

Occupational Safety and Health 

Administration (OSHA) of the U.S. 

Department of Labor has established 

requirements for water used for washing 

workers’ hands. Under 29 CFR 

1928.110(b), a hand-washing facility 

means ‘‘a facility providing either a 

basin, container, or outlet with an 

adequate supply of potable water, soap 

and single-use towels;’’ and potable 

water means ‘‘water that meets the 

standards for drinking purposes of the 

State or local authority having 

jurisdiction, or water that meets the 

quality standards prescribed by the U.S. 

EPA’s National Primary Drinking Water 

Regulations [NPDWR] (40 CFR part 

141).’’ The OSHA requirements in 29 

CFR 1928.110 require that farms 

employing eleven or more employees 

engaged in hand-labor operations in the 

field for a period of more than three 

hours in a day provide water that 

satisfies the microbial maximum 

contaminant level (MCL) in the 

NPDWR, which states that any generic 

E. coli-positive repeat sample or generic 

E. coli-positive routine sample (which 

would include a finding of any 

detectable generic E. coli in 100 ml of 

water using the methods of analysis in 

proposed subpart N) constitutes a 

violation of the MCL for total coliforms. 

Therefore, the microbial standard for 

hand washing water during harvesting, 

packing, and holding activities that is 

specified in proposed § 112.44(a) would 

be consistent with the OSHA 

requirements. 

We acknowledge the difficulty of 

associating specific indicator 

concentrations with specific produce 

related health risks. Even so, we have 

tentatively concluded that such 

difficulty does not negate the value of 

applying generic E. coli test results to 

the requirement to discontinue use of a 

water source until compliance with 

applicable generic E. coli standard is 

again achieved, because elevated 

indicator organism concentrations 

indicate increased levels of fecal 

contamination and elevated potential 

for the presence of human pathogens of 

fecal origin (Ref. 154). The uses listed in 

proposed § 112.44(a) are similar in that, 

if pathogens or fecal contamination are 

present, it is reasonably likely they 

could be transferred directly to covered 

produce through direct or indirect (via 

food-contact surfaces) contact with the 

water. Therefore, testing the agricultural 

water used for these purposes to ensure 

that it is absent of generic E. coli would 

provide reasonable assurances that the 

water does not contain pathogens, and 

therefore that the water is not likely to 

introduce pathogens into or onto 

covered produce and to provide 

reasonable assurances that the produce 

will not be adulterated under section 

402 of the FD&C Act. Moreover, a 

requirement that there be no detectable 

generic E. coli per 100 mL of 

agricultural water used in these 

activities and practices would be 

consistent with EPA’s MCLs for 

microbiological contaminants in public 

drinking water systems (40 CFR 

141.63(b)) and with our standard of 

quality for bottled water (21 CFR 

165.110(b)(2)(B)). We request comment 

on the need for, and appropriateness of, 

this proposed requirement and any 

other criteria that would ensure the 

safety of water for these intended uses. 

We tentatively conclude that we 

should require that if the water you use 

for the purposes listed in § 112.44(a) 

does not meet the microbial standard of 

no detectible generic E. coli per 100 ml, 

you must immediately discontinue use 

of the water and/or distribution system 

for those purposes. Before you use the 

water source and/or distribution system 

again for those uses, you would need to 

either (1) re-inspect the entire 

agricultural water system under your 

control, identify any conditions that are 

reasonably likely to introduce known or 

reasonably foreseeable hazards into or 

onto covered produce or food-contact 

surfaces, make necessary changes, and 

retest the water to determine if your 

changes were effective and to ensure 

that the water meets the required 

microbial standard; or (2) treat the water 

in accordance with the requirements of 

§ 112.43 (proposed § 112.44(b)). This 

proposed requirement is parallel to the 

requirement in proposed § 112.42(d), 

which is discussed above. 

Proposed § 112.44(c) would require 

that when agricultural water is used 

during growing activities for covered 

produce (other than sprouts) using a 

direct water application method, you 

must test the quality of water in 

accordance with one of the appropriate 

analytical methods in subpart N. If you 

find that there is more than 235 colony 

forming units (CFU) (or most probable 

number (MPN), as appropriate) generic 

E. coli per 100 ml for any single sample 

or a rolling geometric mean (n=5) of 

more than 126 CFU (or MPN, as 

appropriate) per 100 ml of water, you 

must immediately discontinue use of 

that source of agricultural water and/or 

its distribution system for the uses 

described in § 112.44(c). Before you may 

use the water source and/or distribution 

system again for the uses described 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 

foreseeable hazards into or onto covered 

produce or food-contact surfaces, make 

necessary changes, and retest the water 

to determine if your changes were 

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effective; or treat the water in 

accordance 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 verification of 

wastewater treatment, and laboratory 

analysis of crop contamination levels 

with generic E. coli at harvest and in 

retail to verify pathogen mortality (dieoff) (Ref. 118). However, they also noted 

the variability in pathogen die-off (0.5– 

2 log/day), dependent on temperature, 

sunlight intensity, crop type, time of 

water application, and other factors. 

Some industry groups have adopted 

the generic E. coli component of the 

U.S. EPA recreational water standards 

(for beaches used frequently) for certain 

uses of agricultural water (Ref. 31. Ref. 

44). In this regard, EPA recommends 

that criteria include a maximum steady 

state geometric mean of 126 CFU of 

generic E. coli per 100 ml and a single 

sample maximum allowable density of 

235 CFU of generic E. coli per 100 ml 

(Ref. 136). British Columbia, Canada has 

announced their intention to use generic 

E. coli criteria for irrigation water used 

on produce consumed raw. Their 

irrigation criteria (less than or equal to 

77 CFU per 100 ml geometric mean) are 

the same as and were derived from 

those used for primary-contact 

recreation (Ref. 137). Similarly, the 

generic E. coli component of EPA’s 

recreational water standard (for beaches 

used frequently) serves as the basis for 

our proposed standard for microbial 

water quality for water used in direct 

application methods during growing 

(proposed § 112.44(c)). 

It should be noted that EPA’s 

recreational water standards for beaches 

used frequently also includes a 

recommendation for a maximum steady 

state geometric mean of 33 CFU of 

enterococci per 100 ml and a single 

sample maximum allowable density of 

61 CFU of enterococci per 100 ml (Ref. 

136). Similarly, the current British 

Columbia criteria for irrigation water 

used on produce consumed raw is a 

geometric mean of less than or equal to 

200 CFU fecal coliform per 100 ml and 

they have announced their intention to 

use a geometric mean of less than or 

equal to 20 CFU enterococci per 100 ml 

(along with generic E. coli, as discussed 

above). We have tentatively concluded 

to not include enterococci or fecal 

coliform in our proposed standard at 

§ 112.44(c) because we believe generic 

E. coli to be the superior indicator of 

fresh water quality and do not believe 

that the added cost of testing for both 

generic E. coli and enterococci is 

warranted. Wade et al (2003) (Ref. 155) 

performed a systematic review of 27 

studies of water quality indicators used 

for the regulation of recreational waters. 

They compared the ability of 

enterococci, fecal coliform, generic E. 

coli and total coliform levels to predict 

for the occurrence of gastrointestinal 

illness. They concluded that for 

freshwater, generic E. coli was the more 

consistent predictor. Working under the 

framework of a WHO project for setting 

guidelines for quality of recreational 

waters and bathing beaches, Pruss 

(1998) (Ref. 156) reviewed 22 studies on 

uncontrolled waters (seas, lakes, and 

rivers) for dose-related relationships 

between GI illness and bacterial 

indicator (most commonly generic E. 

coli, enterococci, and fecal coliforms) 

counts. The author found the two 

indicator organisms which correlate best 

with health outcomes were enterococci 

for both marine and freshwater and 

generic E. coli for freshwater. 

We considered proposing a drinking 

water standard for water used on 

covered produce other than sprouts 

during growing in a direct water 

application method, but tentatively 

conclude that such criteria would be 

unnecessarily restrictive as it would not 

sufficiently account for forces driving 

pathogen die-off (e.g., sunlight, 

competing microorganisms) (see section 

V.E.2 of this document). We also 

considered proposing a second lower 

microbial quality criteria for water used 

in growing, but where the water used for 

irrigation is not reasonably likely to 

contact the edible portion of the covered 

produce (e.g., surface irrigation of tree 

crops). However, we are not aware of 

another standard for which there is 

sufficient scientific support. 

We acknowledge that the EPA 

recreational water standards were 

developed from epidemiological studies 

that correlated the risk of 

gastrointestinal illness to exposure to 

marine and freshwater by swimmers 

(Ref. 136), rather than to consumption of 

produce. These epidemiological studies 

were performed in beach areas subject 

to point source fecal contamination 

rather than non-point sources (e.g., 

birds, agricultural and livestock runoff), 

which may impact agricultural water. 

Further, risks of adverse health 

outcomes resulting from full body 

contact in contaminated water may be 

different than risks associated with 

consuming produce irrigated with 

contaminated water, given the 

differences in the expected routes of 

infection and pathogen mortality rates 

in the different environments (bodies of 

water for the EPA recreational water 

standards; soil, plants, and produce for 

this proposed rule). 

We also acknowledge that the 

proposed standard is more stringent 

than the WHO standard. Based upon an 

analysis of tolerable risk for irrigation 

water, WHO recommends that the 

minimum microbial quality for water 

used on root crops that are eaten raw is 

1000 CFU generic E. coli per 100 ml 

(10,000 CFU generic E. coli per 100 ml 

in leaf crops) (Ref. 118. Ref. 120). 

According to the WHO analysis, using 

water of this microbial quality is 

dependent upon a 2 log reduction due 

to die-off between last irrigation and 

consumption (includes die-off in the 

field and during distribution) and a 1 

log reduction attributed to washing 

prior to consumption. This analysis 

recognizes the variable nature of die-off 

values, ranging from 0.5–2.0 log per day 

(Ref. 118). The WHO analysis considers 

the need for a four log reduction 

through dilution, die-off, or treatment 

between the levels of generic E.coli in 

raw sewage (well represented in sewage 

by fecal coliform levels) and the levels 

in irrigation water used on root crops 

that are eaten raw (3 log for leaf crops), 

in addition to the 3 log reduction 

discussed above. 

We tentatively conclude that the 

recreational water generic E. coli criteria 

would serve to minimize risk of known 

or reasonably foreseeable hazards when 

used as a standard for agricultural water 

used on produce other than sprouts 

during growing in a direct water 

application method. We recognize that 

is somewhat more protective than the 

WHO standard, which we believe is 

appropriate given the uncertainty in dieoff values. We request comment on the 

need for, and appropriateness of, this 

requirement or other criteria that would 

ensure the quality of agricultural water 

used for this purpose. 

We tentatively conclude that if 

agricultural water you use on produce 

other than sprouts during growing in a 

direct application method does not meet 

the microbial water quality described in 

§ 112.44(c), you must immediately 

discontinue use of that source of 

agricultural water and/or its distribution 

system and either (1) re-inspect the 

agricultural water system components 

under your control, identify conditions 

that are reasonably likely to introduce 

hazards to the system, make necessary 

changes based upon your observations, 

and retest the water to determine if your 

changes were effective; or (2) treat the 

water in accordance with the 

requirements of § 112.43. This proposed 

requirement is parallel to the 

requirement proposed § 112.42(d), 

which is discussed above. 

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We tentatively conclude that violation 

of microbial water quality standards 

proposed in §§ 112.44(a) and (c) in and 

of itself would not necessarily establish 

evidence of adulteration of covered 

produce subjected to use of the water, 

nor would it necessarily mean that the 

food was contaminated. However, use of 

water that is shown to violate these 

standards would violate the requirement 

at proposed § 112.41 that all agricultural 

water must be safe and of adequate 

sanitary quality for its intended use. As 

described immediately above, these 

proposed standards are based on 

likelihood of fecal contamination (as 

indicated by the presence of generic E. 

coli), that we have tentatively concluded 

minimize the risk of serious adverse 

health consequences or death by 

preventing the introduction of hazards 

and providing reasonable assurances 

that produce is not adulterated under 

section 402 of the FD&C Act. 

Agricultural water in violation of these 

standards indicates increased likelihood 

of fecal contamination of the water and, 

consequently, increased likelihood of 

produce contamination with human 

pathogens, beyond that which is 

appropriate for the intended use. 

Therefore, we propose to require you to 

immediately discontinue use of that 

source of agricultural water and/or its 

distribution system until you have 

either followed certain prescribed steps 

to mitigate the problem or treated the 

water. 

Under the provisions of proposed 

§ 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 registration under the Federal 

Insecticide, Fungicide and Rodenticide 

Act before they can be lawfully used. At 

the present time, no such registration for 

chemical treatment of irrigation water 

exists. As discussed in section IV.K. of 

this document, FDA is proposing to 

delay implementation of certain 

provisions, including the water quality 

testing requirements in proposed 

§ 112.44, beyond the effective dates for 

other provisions of the rule. The 

proposed extended compliance dates for 

the water quality testing, monitoring, 

and related record keeping requirements 

in proposed §§ 112.44, 112.45, 

112.50(b)(5), 112.50(b)(6), and 

112.50(b)(7) are six years from the 

effective date for very small businesses, 

five years from the effective date for 

small businesses, and four years from 

the effective date for all other farms 

subject to the rule. We expect these 

extended compliance dates to provide 

adequate time for industry to address 

issues related to water quality testing. 

We seek comment on the adequacy of 

this timeline. 

Proposed § 112.44(d) would also 

allow you to establish and use 

alternatives to the requirements 

established in proposed § 112.44(c) 

provided you satisfy the requirements of 

proposed § 112.12. As discussed in 

section V.B. of this document, 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 

agricultural water is used during 

growing operations for covered produce 

(other than sprouts) using a direct water 

application method. We acknowledge 

that in specific circumstances an 

alternative standard (e.g., a standard 

that applies an application interval 

(time between application and harvest) 

in place of the § 112.44(c) standard, but 

is specific to a specific commodity or 

commodity group and region) may be 

appropriate if the alternative standard is 

shown to provide the same level of 

public health protection as the standard 

in proposed § 112.44(c) and not to 

increase the likelihood that the covered 

produce will be adulterated. Therefore, 

we tentatively conclude that it would be 

appropriate to allow for alternatives to 

the requirements in proposed 

§ 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 application method for 

growing covered produce other than 

sprouts as long as it was applied before 

the start of the scientifically established 

application interval (i.e., at a certain 

number of days before harvest or 

earlier). 

Proposed § 112.45 would establish 

requirements related 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 

agricultural water that is subject to the 

requirements of § 112.44 at the 

beginning of each growing season, and 

every three months thereafter during the 

growing season, except that there would 

be no requirement to test water when: 

(1) You receive water from a Public 

Water System, as defined under the Safe 

Drinking Water Act (SDWA) regulations, 

40 CFR Part 141, that furnishes water 

that meets the microbial requirements 

under those regulations or under the 

regulations of a State approved to 

administer the SDWA public water 

supply program, and you have Public 

Water System results or certificates of 

compliance that demonstrate that the 

water meets that requirement; 

(2) You receive water from a public 

water supply that furnishes water that 

meets the microbial requirement 

described in 112.44(a), and you have 

public water system results or 

certificates of compliance that 

demonstrate that the water meets that 

requirement; or 

(3) You treat water in accordance with 

the requirements of § 112.43. 

Water testing frequencies 

recommended by various industry 

documents vary widely, in part because 

there is a lack of publicly available 

information pertaining to the quality of 

irrigation waters. Recommendations 

range from monthly testing to once each 

year, for sources with a history of 

compliance with commodity specific 

recommendations (Ref. 31. Ref. 44). 

Even for sources considered reliable 

(e.g., well water), a one year period 

between testing does not minimize the 

risk of known or reasonably foreseeable 

hazards because microbiological water 

quality, even when sourced from ground 

water sources, is too variable for this 

frequency of testing to be protective 

(e.g., effects of flooding, runoff) (Ref. 

29). Alternatively, we tentatively 

conclude testing more frequently (less 

than every 3 months) would not 

significantly improve the accuracy of 

your assessment of ground water quality 

and would therefore be unnecessary. We 

also considered proposing testing 

frequencies established as a function of 

commodity, irrigation method (e.g., 

furrow, seep, subsurface dripfoliar), and 

timing of application (days prior to 

harvest), and concluded that the most 

effective approach is to test on a 

frequency related to the reliability of the 

agricultural water sources. We 

tentatively conclude that requiring 

testing as a function of time before 

harvest would be impractical for many 

farms as we have observed single 

sources (e.g., a well) providing water for 

multiple crops in different phases of 

production. We request comment on 

whether we should allow for adjustment 

of ground water testing frequencies 

dependent upon historical test results. 

For example, we are considering 

requiring testing ground water sources 

every three months for one year and 

yearly after that if the ground water 

consistently met the standard. We also 

request public comments on our 

proposed approach to frequency of 

testing, each of the options described 

here, and any other alternative testing 

frequencies that can be supported by 

water quality data. 

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Proposed § 112.45(a)(1) provides an 

exception to testing required in 

§ 112.45(a) when the water is sourced 

from a Public Water System or State 

authority approved to administer the 

SDWA public water supply program, 

and you have results of the water testing 

or certificates of compliance that 

demonstrate that the water meets the 

requirements of that program. These 

systems operate so that the water they 

deliver meets the microbial requirement 

in 112.44(a). In the U.S., Public Water 

Systems are required under U.S. EPA 

National Primary Drinking Water 

Regulations (NPDWR) in 40 CFR 141 to 

provide safe, clean water suitable for 

drinking and thus are at the lowest 

likelihood for pathogen contamination. 

Under the sampling, testing and 

reporting requirements of 40 CFR 141, 

we tentatively conclude that additional 

actions by the grower to assure its safety 

are unwarranted. Similarly, proposed 

§ 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 water 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 governed by the requirements of the 

EPA drinking water program, but 

provide water of a quality that meets the 

microbial 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 operations, 

we are not aware of anything suggesting 

a need for additional testing at its 

delivery point to the farm. We seek 

comments on this issue, including any 

practice(s) that could materially change 

the quality of public or municipal water 

between treatment and delivery to the 

farm, including changes in water quality 

during water distribution and holding. 

Finally, § 112.45(a)(3) exempts from 

testing water that you treat in 

accordance with proposed § 112.43, 

which is discussed above. 

Proposed § 112.45(b)(1) would 

establish that if you use untreated 

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 subject to the 

requirements of proposed § 112.44, and 

if the untreated surface water is from 

any source where underground aquifer 

water is transferred to a surface water 

containment constructed and 

maintained in a manner that minimizes 

runoff drainage into the containment 

(for example, an on-farm man-made 

water reservoir), then you must test the 

water at least once each month during 

the growing season. 

Surface water is subject to a great 

number of environmental factors that 

may alter its microbial water quality as 

discussed in the QAR and, when 

untreated, presents a significant source 

of pathogen contamination of produce. 

We tentatively conclude that the most 

important among these is runoff, 

because it has the potential to increase 

the number of pathogens in the water 

column if its origins include human, 

livestock or wildlife feces and because 

it has the potential to increase the 

amount of suspended sediments, which 

are likely to harbor pathogens (Ref. 157. 

Ref. 154). In proposing these testing 

frequencies, we tentatively divided 

untreated surface water into two 

categories based upon their potential to 

be impacted by runoff and the degree to 

which you reasonably could be 

expected to exercise protection and 

control over them. Flowing surface 

waters (e.g., river, stream, or creek) or 

sources that are not protected against 

runoff (e.g., natural ponds, lakes) must 

be tested at a relatively higher 

frequently than surface waters for which 

you have direct control and which you 

can manage in a way so to minimize the 

effect of runoff and other sources of 

contamination (e.g., on-farm reservoir or 

pond). Contamination events that can 

lead to surface water contamination can 

have profound effects on the quality of 

the water, but those effects can be 

fleeting, especially those involving 

runoff from rainfall (several days to 

several weeks). After the contamination 

event passes, water quality generally 

returns to background levels (Ref. 158). 

If sampling is less frequent than weekly 

from surface water sources subject to 

these kinds of contamination events, 

there is a good chance that some 

contamination events will go 

undetected. On the other hand, for 

surface water sources that are not 

subject to significant runoff, the water 

quality tends to remain stable, and the 

purpose of sampling is primarily to 

accurately characterize the background 

level. Monthly sampling provides 12 

samples per year that give a good 

representation of the quality of water 

through the seasons. The sampling and 

testing frequencies proposed in 

§ 112.45(b) are the minimum that we 

tentatively conclude provide sufficient 

information concerning your source 

surface water quality for you to use in 

determining method of application and 

its timing for which the water is safe 

and of adequate sanitary quality. We 

encourage additional sampling if you 

have reason to believe that its quality 

may have changed from the previous 

test. We welcome comments on the 

need for, and appropriateness of, our 

proposed testing frequencies, including 

any alternative approaches and 

examples where testing should be more 

or less frequent based upon your 

experience or observation. 

The monitoring frequencies proposed 

in this rule are practical intervals that 

we tentatively conclude are reflective of 

the varying potential for changes in 

water quality between ground aquifers 

and surface watersheds. In proposing 

the monitoring frequencies for untreated 

surface waters, we considered factors 

that are most likely to impact water 

quality. Precipitation and its effects 

(e.g., discharge and flow rate) along with 

temperature are common factors 

reported to affect the microbial quality 

of watersheds with agricultural land 

inputs (Ref. 159. Ref. 158). Precipitation 

levels have also been successfully used 

to manage openings and closings of 

molluscan shellfish harvest areas. These 

harvest areas are well characterized in 

terms of changes in the microbial water 

quality due to non-point source runoff 

as a consequence of rainfall. However, 

we have not proposed surface water 

testing frequency based upon 

precipitation because such an approach 

would require full characterization of its 

effects (Ref. 143) on the quality of 

surface water sources that are not likely 

to be generally useful across farms, 

States, or regions. Our approach to 

testing untreated surface water is to 

propose practical intervals of testing 

both because they are likely to capture 

transient events that may degrade 

quality and because they are useful 

regardless of geographic location. We 

welcome comments on this approach, 

including any alternate approaches, 

specifically if you believe that surface 

waters can be thoroughly characterized 

such that they require less frequent 

testing than proposed in § 112.45. 

e. Requirements for Water Used in 

Harvesting, Packing, and Holding 

Activities 

Proposed § 112.46 would establish the 

measures you must take for water that 

you use during harvest, packing, and 

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holding activities for covered produce. 

Specifically, proposed § 112.46(a) 

would require that you manage the 

water as necessary, including by 

establishing and following water-change 

schedules for re-circulated water, to 

maintain adequate sanitary quality and 

minimize the potential for 

contamination of covered produce and 

food-contact surfaces with known or 

reasonably foreseeable hazards (for 

example, hazards that may be 

introduced into the water from soil 

adhering to the covered produce). The 

proposed language allows sufficient 

flexibility for you to establish measures 

that are best suited to your needs based 

on practice and experience. For 

example, you may establish a waterchange schedule for water used in an 

apple flume based upon the rate of 

product flow, organic load, or other 

variables you determine best correlate 

with safety and sanitary quality of the 

flume water. Many commonly used 

wash water antimicrobials have 

decreased efficacy when organic matter 

is present in the water. For example, 

organic matter builds up in agricultural 

water flume systems from dirt and 

debris on the surface of fresh produce 

that are placed into the flume systems. 

Once the soluble and/or insoluble 

organic load builds up to sufficiently 

high levels, the addition of wash water 

antimicrobials becomes ineffective and 

inefficient. Changing the flume water on 

a regular basis, based on that system’s 

unique operating conditions, can assure 

that wash water disinfection treatments 

are consistently effective (Ref. 149. Ref. 

150). We point out that while water 

disinfection is one means to manage 

water quality, we are not specifically 

proposing to require disinfection 

treatment of re-circulated or single use 

water that is used in harvesting, 

packing, or holding activities. We are 

proposing that re-circulated or single 

pass water must be safe and of adequate 

sanitary quality for its intended use 

(§ 112.41) and that it contain no 

detectable E. coli (§ 112.44(a)). Further, 

if you have reason to believe that the 

water is not safe and of adequate 

sanitary quality for its intended use, 

proposed provisions in § 112.43 for 

water treatment can be applied. 

However, we are not proposing 

treatment of water as the only option. 

Other options for farms include making 

changes to the system and retesting the 

water successfully (§ 112.42(d)) and 

using the same water source for other 

uses for which it does qualify. For 

example, using water that does not meet 

the zero E. coli standard but does meet 

the 235 CFU per 100 ml standard for 

direct application method irrigation of 

produce other than sprouts; or for water 

that does not meet the 235 CFU per 100 

ml standard, applying the water for 

irrigation in a different manner that is 

not a direct application method 

(§ 112.44). These provisions offer 

flexibility for farms to choose among 

different options to ensure that the 

water is safe and adequate for the 

purpose for which it is intended. 

Should farms choose to disinfect water 

as a measure to control waterborne 

hazards during handling during and 

after harvest, we tentatively conclude 

that an effective disinfection program 

would render such water safe and of 

adequate sanitary quality. However, we 

request public comment on the 

appropriateness of this tentative 

conclusion and on whether a provision 

specifically directed to disinfection of 

water used during and after harvest is 

needed. We also seek public input 

regarding practices or conditions when 

disinfection of re-circulated or single 

use water would be unnecessary, 

inappropriate, or impractical. 

Proposed § 112.46(b) would require 

that you visually monitor the quality of 

water that you use during harvest, 

packing, and holding activities for 

covered produce (for example, water 

used for washing covered produce in 

dump tanks, flumes, or wash tanks, and 

water used for cooling covered produce 

in hydrocoolers) for build-up of organic 

material (such as soil and plant debris). 

Organic matter such as soil and plant 

debris has to the potential to adversely 

affect the quality of water; it may be a 

source of bacteria (including pathogens), 

support the growth of bacteria, and 

reduce the effectiveness of antimicrobial 

compounds (e.g., chlorine compounds) 

(Ref. 150). Such monitoring allows you 

to recognize conditions that require 

action, such as a water change in a 

dump tank. 

Proposed § 112.46(c) would require 

that you maintain and monitor the 

temperature of water at a temperature 

that is appropriate for the commodity 

and operation (considering the time and 

depth of submersion) and is adequate to 

minimize the potential for infiltration of 

microorganisms of public health 

significance into covered produce. 

Water temperature can influence 

processes leading to infiltration of 

microorganisms into many types of 

produce. As discussed in the QAR, 

infiltration of water containing 

pathogens into produce has been 

demonstrated in apples (Ref. 160), 

oranges (Ref. 161), tomatoes (Ref. 138. 

Ref. 139), and mangoes (Ref. 38) and 

was suggested to play a role in a 1999 

Salmonella outbreak associated with 

mangos (Ref. 162). A recent study 

demonstrated that additional factors, 

such as tomato variety and the time 

delay between tomato stem removal and 

water immersion have a significant 

impact on the frequency and population 

of internalized Salmonella in tomatoes. 

(Ref 140). However, this study also 

demonstrated that Salmonella 

internalization of tomatoes via their 

stem scar can occur even under a zero 

temperature differential, and 

temperature differentials up to 10 °F 

have no effect on the internalization 

frequency and have limited impact on 

Salmonella cell populations 

internalized in tomatoes. 

We considered proposing a single 

standard on temperature differential 

between water and product core 

temperature (e.g., water must be at least 

10 degrees F warmer than core) but 

tentatively conclude that there is 

insufficient scientific evidence 

supporting such a standard across all 

covered produce. However, we 

recognize the North American Tomato 

Trade Work Group and California 

Tomato Commission have 

recommended such a standard (Ref. 44). 

We seek public comment on the need 

for, and appropriateness of, the 

proposed provisions, including any 

alternative approaches that you found to 

be effective through experience or 

observation. 

f. Records Requirements 

Proposed § 112.50 would establish 

requirements about the records that you 

would need to establish and keep under 

this proposed subpart E. Specifically, 

proposed § 112.50(a) would require that 

you establish and keep records required 

under this proposed subpart E in 

accordance with the requirements of 

proposed subpart O. Proposed 

§ 112.50(b) would require that you 

establish and keep the following 

records: 

(1) The findings of the inspection of 

your agricultural water system in 

accordance with the requirements of 

proposed § 112.42(a); 

(2) Documentation of the results of 

any analytical tests conducted to 

determine whether agricultural water is 

safe and of adequate sanitary quality for 

its intended use; 

(3) Scientific data or information you 

rely on to support the adequacy of a 

method used to satisfy the requirements 

of § 112.43(b) and (c)(1); 

(4) Documentation of the results of 

water treatment monitoring under 

§ 112.43(c)(2); 

(5) Documentation of the results of 

water testing you perform to satisfy the 

requirements of § 112.44; 

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(6) Scientific data or information you 

rely on to support any alternative to the 

requirements established in § 112.44(c) 

for agricultural water used during 

growing activities using a direct water 

application method in accordance with 

the requirements of § 112.44(d); and 

(7) Annual documentation of the 

results or certificates of compliance 

from a public water system under 

112.45(a)(1) or (2), if applicable. 

Proposed § 112.50(b)(1) would require 

that you establish and keep records of 

agricultural water system inspection 

findings in order for FDA to verify 

compliance with the proposed 

requirement to inspect the agricultural 

water system. The records would also 

allow you to more effectively manage 

your agricultural water, to identify 

trends and changes in your agricultural 

water system over time, and to help 

identify potential sources of 

contamination of the water system and 

covered produce. In addition, these 

records may aid you in determining the 

most appropriate frequencies for 

maintenance of well and surface water 

sources, distribution and holding 

systems. 

Proposed § 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 

are necessary because otherwise FDA 

would have no way to determine 

whether you were making appropriate 

decisions about whether your water is 

safe and of adequate sanitary quality for 

its intended use. When such tests are 

conducted, results of those tests are also 

fundamental in making informed 

decisions concerning your use of water. 

We are proposing under § 112.50(b)(3) 

and (4) that you must establish and keep 

scientific information or data 

documenting the effectiveness of the 

treatment method that you use and 

records demonstrating that you deliver 

the treatment consistently to ensure the 

water is safe and of adequate sanitary 

quality. These records may include 

information provided by the 

antimicrobial product supplier, product 

labels with instructions for use, product 

material safety data sheets (MSDS), 

batch test results demonstrating correct 

active ingredient concentration, mixing 

proportions, and schedules or 

application rates you have developed to 

ensure water is treated effectively. They 

may also include results of testing you 

perform to confirm your treatment 

methods are being followed, such as 

records of active ingredient 

concentration, pH, temperature, flow 

rate, immersion time, or water changes, 

if they significantly impact the 

effectiveness of the treatment. 

Monitoring frequency may be affected 

by product flow, organic load on 

incoming product, temperature, UV 

exposure, and consumption rates or 

breakdown rate (expected and observed) 

for the active antimicrobial compound, 

among other factors. These records are 

necessary so that FDA can verify your 

compliance with those requirements. 

They will also allow you to ensure your 

own compliance with the requirements 

for water treatment in proposed 

§ 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 requirements 

of § 112.44. For example, records for 

water tests you perform to ensure input 

water used in sprout production meets 

the requirements in § 112.44(a) would 

include, at a minimum, the test date, 

specific water source (e.g., municipal 

water or well number 3), method name 

(e.g., multiple tube fermentation, 

membrane filter method, presenceabsence test, and commercial product 

name, if applicable) and the test result 

(e.g., not detected, generic E. coli MPN 

or CFU, as applicable). Records you 

maintain to demonstrate the microbial 

water quality meets the requirements of 

§ 112.44(c) for foliar application of 

spinach would include, at a minimum, 

the test date, specific water source (e.g., 

ranch X, well 3 or canal collection point 

2), method name (e.g., multiple tube 

fermentation, membrane filter method, 

and commercial product name, if 

applicable) and the test result (e.g., E. 

coli MPN or CFU, as applicable). We 

tentatively conclude that documentation 

of the results of water testing are 

necessary to demonstrate that the water 

you use meets the requirements of 

§ 112.44 and to provide a history of the 

microbial quality of your water system, 

which will be useful in spotting 

problems before they occur, minimizing 

the potential for water to be a source of 

contamination to covered produce. 

These records are necessary so that FDA 

can verify your compliance with those 

requirements and so that you can ensure 

your own compliance with the 

requirements for water testing and 

responding to test results in proposed 

§ 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 alternative to the 

requirements established in § 112.44(c) 

for agricultural water used during 

growing activities using a direct water 

application method in accordance with 

the requirements of § 112.44(d). Such 

documentation will enable us to verify, 

and you to ensure, that the alternative 

standard you use provides the same 

level of public health protection as the 

standard in proposed § 112.44(c) and 

does not increase the likelihood that the 

covered produce will be adulterated, in 

accordance with proposed § 112.12. 

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 that system 

supplies water meeting the microbial 

requirements of § 112.45(a)(1) or (2), if 

applicable. We tentatively conclude that 

maintaining such annual documentation 

is necessary for FDA to verify that the 

water you use is not subject to the 

requirements for testing under proposed 

§ 112.45 and to ensure that it meets the 

microbial requirements of proposed 

112.44, and for you to demonstrate that 

those requirements have been met. We 

seek comment on the appropriateness of 

the proposed record-keeping 

requirements. 

F. Subpart F—Standards Directed to 

Biological Soil Amendments of Animal 

Origin and Human Waste 

Proposed subpart F establishes 

standards directed to treated and 

untreated biological soil amendments of 

animal origin and human waste. These 

standards include requirements 

applicable for determining the status of 

a biological soil amendment of animal 

origin; procedures for handling, 

conveying, and storing biological soil 

amendments of animal origin; 

provisions regarding the use of human 

waste in growing covered produce; 

acceptable treatment processes for 

biological soil amendments of animal 

origin applied in the growing of covered 

produce; microbial standards applicable 

to treatment processes; application 

requirements and minimum application 

intervals; requirements specific to 

agricultural teas; and records 

requirements. The proposed 

requirements in subpart F derive from 

current recommendations in our GAPs 

guidance (Ref. 10), commodity-specific 

guidances (Ref. 31) (Refs. LGMA), State 

regulations (Ref. 90. Ref. 163. Ref. 164), 

other Federal Regulations (40 CFR 503, 

7 CFR 205), and international guidelines 

(Ref. 100. Ref. 51). 

1. Comments Relevant to Proposed 

Requirements 

We received several comments in 

response to the 2010 FR notice that 

addressed issues relevant to biological 

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3574 Federal Register / Vol. 78, No. 11 / Wednesday, January 16, 2013 / Proposed Rules 

soil amendments of animal origin and 

human waste. 

a. Definitions 

One comment stated that manure and 

compost are two different things, and 

the two words should not be used 

interchangeably as it causes confusion. 

We agree. As discussed in the QAR, and 

noted in the Produce Safety Project 

Issue Brief on Composting of Animal 

Manures there are documented 

differences in the populations and level 

of human pathogens in raw manure and 

animal feces and in properly composted 

manure (Ref. 27). We are proposing 

definitions that make the distinction 

clear. We are proposing to use the 

phrase ‘‘untreated biological soil 

amendments of animal origin’’ as a 

category that includes raw manure (see 

proposed § 112.3(c) and section 

V.A.2.b.iii of this document regarding 

‘‘biological soil amendment of animal 

origin,’’ and proposed § 112.51(a) and 

section V.F.2.a of this document 

regarding ‘‘untreated’’ biological soil 

amendments of animal origin). We use 

the term ‘‘treated biological soil 

amendments of animal origin’’ to 

include treatments that meet the 

requirements of the standards presented 

in this subpart (see proposed § 112.51(a) 

and section V.F.2.a of this document). 

To further alleviate confusion, we use 

the term ‘‘compost’’ as a verb, to mean 

the act of composting, and do not use it 

as a noun to describe a soil amendment 

that was treated by a composting 

method. Instead, we use the term 

‘‘humus’’ in its common agricultural 

meaning (see proposed § 112.3(c) and 

section V.A.2.b.iii of this document). 

b. Consideration of Other Regulations 

and Guidances 

Comments from growers whose 

operations are certified for organic 

produce requested us to ensure that our 

regulations do not interfere with 

existing organic certification systems or 

organic production practices. Another 

comment stated that the California code 

of regulations for composting yards (Cal. 

Code Regs. title. 14, ch. 3.1) would be 

an acceptable starting point in 

developing our regulations. 

We consider that organic production 

practices and food safety are not crosscompeting goals. In developing the 

provisions proposed in this rule, we 

consulted with technical experts and 

representatives from other Federal 

Agencies, including the Environmental 

Protection Agency, the Department of 

Agriculture (including both the National 

Organic Program and the Natural 

Resources Conservation Service), and 

the Department of the Interior (Fish & 

Wildlife Service) (Ref. 115). As 

discussed in section III.A.8. of this 

document, we tentatively conclude that 

compliance with the provisions of this 

proposed rule would not preclude 

compliance with the requirements for 

organic certification in 7 CFR part 205, 

and we seek comment on this tentative 

conclusion. Use of organic practices 

alone is not sufficient to ensure food 

safety. The use of raw manure at a time 

close to harvest, during organic or 

conventional production, presents a 

significant likelihood of contamination 

of covered produce if produce is 

reasonably likely to contact the soil. On 

this particular issue, and as discussed in 

sections II.E.4 and V.B of this document, 

we are working with USDA and other 

stakeholders to conduct research on 

application intervals necessary to 

ensure the safety of covered produce 

when raw manure is applied to a 

growing area and covered produce is 

reasonably likely to contact the soil. We 

also note that we considered several 

regulations, recommendations, and 

guidelines that address soil 

amendments, including those from 

State, federal, and international 

agencies, industry, and trade 

associations (including the California 

code of regulations for composting 

yards). In addition, we consulted with 

experts from multiple organizations and 

academia for scientific and technical 

input on the issues addressed in these 

provisions. The provisions proposed 

take into account information and input 

gathered through these consultations. 

c. Treatments, Processes, and Practices 

One comment suggested that many 

growers are accepting food waste 

compost, which has no manure in it but 

can often have a readily detectable level 

of Salmonella, and stated that ‘‘green 

waste’’ (or similar) does not necessarily 

equate to zero risk. Comments stated 

that if raw manure is used, there should 

be a science- and risk-based standard for 

determining the application-to-harvest 

waiting interval and that maximizing 

the time interval between soil 

amendment application and harvest is 

only logical if using fresh manure. 

Similarly, one comment stated that raw 

manure can be applied to soil if it is 

plowed and then given sufficient time 

before planting. 

Our review of various composting 

methods suggests that, regardless of the 

source, if the process is properly 

conducted (including proper turning of 

feedstock) the expected pathogen load 

and subsequent likelihood of produce 

contamination can be minimized. We 

agree that certain sources, including 

plant material (Ref. 165) and animal 

sources (Ref. 166), have differing 

likelihood of containing human 

pathogens or higher population levels of 

human pathogens. To address this 

concern, we propose separate, but 

related, provisions. First, we do not 

propose treatment or timing restrictions 

for biological soil amendments that do 

not contain any animal waste product or 

human waste (such as would be the case 

with yard waste, purely vegetative 

matter, or shrub trimmings, or 

agricultural teas made from such 

materials). Such biological soil 

amendments would not be subject to the 

requirements in proposed subpart F 

because they would not fit the 

definition of ‘‘biological soil 

amendments of animal origin’’ and they 

do not contain human waste. Further, in 

§ 112.51(b)(4) we propose that a 

biological soil amendment of animal 

origin contains a component that is 

untreated waste that you know or have 

reason to believe is contaminated with 

a hazard or has been associated with 

foodborne illness, you must regard it as 

if it were an untreated biological soil 

amendment of animal origin for 

application and treatment purposes if 

you still wish to utilize it. In addition, 

we treat ‘‘table waste’’ as ‘‘animal 

waste’’ for the purposes of the definition 

of biological soil amendments of animal 

origin. As discussed in the QAR, postconsumer waste, or table waste (such as 

plate scrapings), has a greater likelihood 

of being contaminated, or contaminated 

at higher populations, with human 

pathogens due to its unknown content 

(e.g., animal products, vegetable 

products, etc.) and its greater likelihood 

of containing human fluids or waste 

(e.g., spittle, vomitus, etc) (Ref. 167). 

Proposed § 112.56(a)(1)(i) would 

require that if you apply a biological soil 

amendment of animal origin that is 

untreated (such as raw manure), where 

covered produce is reasonably likely to 

contact the soil after application, the 

material must be applied in a manner 

that does not contact covered produce 

during application and minimizes the 

potential for contact with covered 

produce after application and the 

minimum application interval is nine 

(9) months. In section V.F.2.f. of this 

document we discuss the reasons for 

this proposed requirement in detail. 

Proposed § 112.56(b) would allow you 

to establish and use an alternative 

application interval under certain 

conditions (discussed further in section 

V.B. of this document). In situations 

where the covered produce will not 

contact the soil after application, 

proposed § 112.56(a)(1)(ii) would 

require that the biological soil 

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amendment of animal origin be applied 

in a manner that does not contact the 

produce at or after application, but 

would not require an application 

interval. Also, as discussed in section 

II.E.4. of this document, FDA is 

collaborating with partners on research 

that may provide scientific support for 

specific alternatives to this proposed 

application interval. 

One comment stated that compost 

made with animal manure must meet 

temperature, mixing, and time 

requirements to ensure its safety, 

whereas another comment stated that 

biologically active soil suppresses 

pathogens and that E. coli pathogens 

decline more rapidly in soils with a 

large diversity of microorganisms rather 

than in sterile soils. One comment 

recommended that we require compost 

operations to have standard operating 

procedures, a quality assurance plan, 

compost testing within specified 

timeframes of sale, and a Hazard 

Analysis Critical Control Point (HACCP) 

program. According to this commenter, 

several growers are requesting testing 

prior to purchase, and are refusing 

compost that has not been recently 

tested. 

Based on our review of the literature 

and as discussed in our QAR, we 

determined that improper composting 

will not have the desired pathogen 

reduction effect, and may enhance the 

survival of pathogenic organisms (Ref. 

168). Therefore, we propose specific 

time and temperature controls for 

composting procedures in proposed 

§ 112.54(c), and further recognize the 

need for composters to consider other 

factors that will impact the successful 

treatment of their particular composting 

situation (e.g., feedstock, C:N ratios, 

pH). We consider that the potential 

effects of soil ecological diversity on 

pathogen populations are regionally 

specific, and may be highly effective 

under some circumstances, while 

potentially inert under other 

circumstances. We recognize the need 

for consistent treatment by suppliers of 

treated biological soil amendments of 

animal origin, and for assurance by 

those that use such amendments that 

the material has been produced under 

adequate conditions, to avoid it being a 

source of contamination. We have 

tentatively concluded that the most 

reliable and least burdensome proposal 

regarding the use of purchased treated 

biological soil amendments of animal 

origin is to require growers to obtain 

certain documentation (such as a 

Certificate of Conformance) from the 

treating operation that validated 

treatment methods were utilized, the 

treatment process is periodically 

verified through testing, and good 

handling practices were followed. This 

is proposed in subpart 112.60(b)(2) and 

we request comment on this proposed 

requirement, including periodic 

verification through testing. 

d. Testing for Pathogens 

Several comments suggested that 

variable minimum application-toharvest waiting intervals should be 

applied using science-based knowledge 

about pathogen levels in and transfer 

from compost, and that if a compost 

tests pathogen-free, there should be no 

time limit between application, 

planting, and harvest. Another comment 

stated that pathogen testing has 

significant limitations, and that it would 

be more important to evaluate a 

treatment process to ensure that it is 

effective in inactivating pathogens. 

We considered testing of individual 

lots of biological soil amendments of 

animal origin as a means to determine 

if they were suitable for application to 

a fresh produce growing area and 

tentatively conclude that such testing is 

not a reliable means of determining the 

safety or expected likelihood of 

contaminating produce by use of 

biological soil amendments of animal 

origin. We have multiple concerns that 

led us to this conclusion. First, we were 

unable to determine standardized 

testing methods, such as sample 

collection methods, sample collection 

times, or location of sample collection, 

which would yield repeatable and 

reliable results under different 

circumstances. Second, we were unable 

to determine the frequency and sample 

size that would reliably indicate the 

microbiological safety of a given manure 

lot. Third, we recognize that there are 

numerous pathogens which may be 

present in biological soil amendments of 

animal origin and that pathogen testing 

would be necessary for all such 

potential contaminants, which would be 

a significant economic burden. 

Therefore, we tentatively conclude that 

an approach that is the most reasonable 

and the most protective of public health 

would involve the use of treatments that 

have been validated to meet certain 

specified microbial standards as 

proposed in this subpart. 

e. Research Needs 

Some comments suggested that there 

is a need for research to identify means 

other than through heat to inactivate 

pathogens, and that such alternative 

approaches may be more practical for 

farmers. Comments opined on the use of 

chemical inactivation, and noted that 

the effectiveness of use of volatile acids 

or ammonia in the inactivation of 

pathogens is not fully established but 

that further research may help refine 

time and temperature parameters for 

chemical inactivation. 

We agree that further research and 

innovation may lead to alternatives to 

heat treatments. Proposed § 112.54 

addresses the use of physical processes, 

chemical processes, or combinations of 

physical and chemical processes, in 

addition to composting, that may be 

used as treatments for biological soil 

amendments of animal origin, provided 

that they meet the applicable 

requirements of § 112.55 and the treated 

biological soil amendment of animal 

origin is applied in accordance with the 

applicable requirements 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 foster innovation and 

development of new means of treating 

biological soil amendments of animal 

origin to ensure produce safety. 

2. Proposed Requirements 

As proposed in § 112.3, ‘‘soil 

amendment’’ would be defined to mean 

any chemical, biological, or physical 

material (such as elemental fertilizers, 

humus, manure, non-fecal animal 

byproducts, peat moss, perlite, preconsumer vegetative waste, sewage 

sludge biosolids, table waste, 

agricultural tea and yard trimmings) 

intentionally added to the soil to 

improve the chemical or physical 

condition of soil in relation to plant 

growth or to improve the capacity of the 

soil to hold water. Additionally, 

‘‘biological soil amendment’’ would be 

defined in § 112.3 to mean any soil 

amendment containing biological 

materials such as humus, manure, nonfecal animal byproducts, peat moss, preconsumer vegetative waste, 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 

origin’’ to mean a biological soil 

amendment which consists, in whole or 

in part, of materials of animal origin, 

such as manure or non-fecal animal 

byproducts, or table waste, alone or in 

combination, and would specify that the 

term does not include any form of 

human waste. See section V.A.2.b.iii. of 

this document. Proposed subpart F is 

focused on biological soil amendments 

of animal origin, which include animal 

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manures and other materials of animal 

origin that you intentionally add to a 

growing area, and on human waste. 

Standards directed to animal feces 

deposited by domestic or wild animals 

that are not a part of your planned 

growing activities (e.g., by working 

animals, by animals that graze or 

encroach into your growing areas) are 

proposed to be included in subpart I, as 

discussed in section V.I. of this 

document. 

As discussed in the QAR, animal 

waste is likely to contain bacterial 

pathogens (e.g., Campylobacter, 

Salmonella spp., enterohemorrhagic E. 

coli) and various other pathogens such 

as parasites (e.g., Cryptosporidium 

parvum, helminthes), which may infect 

humans. The type of pathogen that may 

be present, and the extent to which it 

may be present, is dependent on the 

source of the manure (e.g., E. coli is 

more common from ruminants such as 

cattle, whereas Salmonella is more 

common from fowl such as chickens) 

and the rearing practices of the source 

animals (e.g., animals from densely 

populated farms or farms with a high 

population of immature animals have an 

increased likelihood of harboring 

various pathogens) (Ref. 169). Enteric 

(or gastroinstestinal) pathogens are not 

generally considered to be 

environmental, and are more commonly 

expected to be derived (and in higher 

populations) from a human or animal 

source (e.g., through feces, mortalities, 

blood, spittle, etc.) (Ref. 170). Material 

that does not contain any animal waste 

is far less likely to harbor these food 

safety hazards at microbial populations 

that can reasonably be expected to lead 

to severe adverse health consequences 

or death (Ref. 94). We have tentatively 

concluded that the likelihood of 

contaminating produce by use of 

biological soil amendments that do not 

contain animal waste or human waste 

(e.g., yard trimmings, pre-consumer 

vegetative waste) carrying human 

pathogens is low. Similarly, we are 

unaware of a situation in which 

chemical and physical soil 

amendments, such as elemental 

fertilizers (e.g., potash, aqueous 

nitrates), soil stabilizers (e.g., sand or 

crushed rock) or others typically made 

of mined or synthetic materials, have 

served as sources of microbial 

contamination and, therefore, neither 

chemical nor physical soil amendments 

are a focus of provisions of this rule. 

Therefore, in this proposed subpart F, 

we are proposing to focus on biological 

soil amendments of animal origin and 

human waste, which present a 

reasonable likelihood of harboring 

human enteric pathogens. Unless 

otherwise specifically noted, chemical 

soil amendments, physical soil 

amendments, and biological soil 

amendments that are not of animal 

origin (other than those that contain 

human waste, which are covered by 

proposed § 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 

requirements for determining the status 

of a biological soil amendment of 

animal origin for use in covered 

activities. Proposed § 112.51(a) would 

categorize a biological soil amendment 

of animal origin as treated if it has been 

processed to completion to adequately 

reduce microorganisms of public health 

significance in accordance with the 

requirements of § 112.54, or in the case 

of an agricultural tea, the biological 

materials used to make the tea have 

been so processed and the water used to 

make the tea satisfies the requirements 

of 112.44(a). Section 112.51(b) would 

categorize a biological soil amendment 

of animal origin as untreated if: (1) It 

has not been processed to completion in 

accordance with the requirements of 

§ 112.54, or in the case of an agricultural 

tea, the biological materials used to 

make the tea have not been so processed 

or the water used to make the tea does 

not satisfy the requirements of 

112.44(a); (2) it has become 

contaminated after treatment; (3) it has 

been recombined with an untreated 

biological soil amendment of animal 

origin; (4) it is or contains a component 

that is untreated waste that you know or 

have reason to believe is contaminated 

with a hazard or has been associated 

with foodborne illness; or (5) it is an 

agricultural tea that contains an 

agricultural tea additive. 

Proposed § 112.51(a) would provide a 

simple method of referring to biological 

soil amendments of animal origin as 

treated if they have received one of the 

treatment processes described in 

proposed § 112.54. We discuss those 

treatment process options in detail in 

section V.F.2.d of this document. 

Agricultural teas are mentioned 

separately for two reasons. First, 

treatments are typically applied to the 

biological materials used to make 

agricultural teas rather than to the teas 

themselves and our explicit mention of 

this fact is intended to aid in clarity. 

Second, we specify that the water used 

to make a treated agricultural tea must 

meet the standard in proposed 

§ 112.44(a) to prevent the introduction 

of pathogens into treated agricultural 

teas, which can be applied with fewer 

application restrictions than untreated 

agricultural teas in accordance with 

proposed § 112.56. As discussed in 

section V.E.2.d of this document, the 

conditions under which agricultural tea 

is produced (moist and nutrient-rich) 

support the multiplication of pathogens, 

if present (Ref. 142). Even a low number 

of pathogens introduced into or onto 

covered produce through contaminated 

water could rapidly increase to levels 

that could present risk of serious 

adverse health consequences or death to 

those who consume the covered 

produce for which the tea was used 

(Ref. 142). 

Proposed § 112.51(b) addresses the 

situations in which a biological soil 

amendment of animal origin should be 

regarded as untreated because they 

present a greater likelihood of 

contamination to covered produce than 

a treated biological soil amendment of 

animal origin. A treated biological soil 

amendment of animal origin can be 

expected to have a high content of 

available nutrients and minerals which 

can support rapid and prolific microbial 

population growth if sufficient moisture 

is available, possibly with limited 

competitive native microflora (Ref. 171) 

(depending on the specific treatment, 

treatment parameters, and handling 

used, (e.g., heat treated poultry manure 

pellets would be expected to have 

limited microorganism content 

including competitive native microflora, 

and composted manure would be 

expected to have substantial 

competitive native microflora)) (Ref. 

171. Ref. 172). Accordingly, pathogens 

could grow prolifically in a treated 

biological soil amendment of animal 

origin if it were to become contaminated 

through contact or partial mixing with 

an untreated biological soil amendment 

of animal origin, or other potential 

contaminant source, and if sufficient 

moisture were available (Ref. 171). 

Prolific microbial growth could also 

occur through premature termination of 

treatment, which could leave surviving 

microorganisms and a higher moisture 

content than after composting is 

completed. In addition, if a biological 

soil amendment of animal origin 

contains a component that is untreated 

waste that you know or have reason to 

believe is contaminated with a hazard or 

has been associated with foodborne 

illness, we tentatively conclude that the 

increased likelihood of pathogen 

presence in such materials results in a 

need to apply the most stringent 

controls to their use in the growing of 

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covered produce. Prolific growth of a 

human pathogen in a nutrient-rich, 

possibly competition poor, biological 

soil amendment of animal origin could 

lead to the amendment acting as an 

inoculum that spreads microorganisms 

on any field or covered produce growing 

area to which the amendment may be 

applied, leading to a potential 

significant likelihood of produce 

contamination. To avoid such 

inoculation, we propose to require you 

to regard any biological soil amendment 

of animal origin that is partially or 

incompletely treated as an untreated 

biological soil amendment of animal 

origin. Finally, we tentatively conclude 

that agricultural teas that contain 

agricultural tea additives should be 

regarded as untreated biological soil 

amendments in light of their content 

and the likelihood that they contain 

human pathogens. 

As discussed in section V.F.2.f. of this 

document, we tentatively conclude that 

the treatment process (including 

composting processes) can reduce the 

populations of pathogens significantly. 

However, it has been recently reported 

that while pathogens that are present in 

agricultural teas made from properly 

composted humus are reduced to 

undetectable levels within 8.5 days, 

such agricultural teas with added 

nutrient supplements (i.e., agricultural 

tea additives) allow low populations of 

remaining E. coli O157:H7, Salmonella, 

and fecal coliforms to grow and 

multiply (Ref. 142). For this reason, we 

propose to impose the same application 

restrictions on agricultural teas that 

have been prepared with nutrient 

additives as those that we propose for 

the use of untreated biological soil 

amendments of animal origin, such as 

raw manure (proposed § 112.56(a)(1)(i)), 

and seek comment on this proposal. See 

section V.F.2.f. of this document for 

further discussion of the reasons for 

these restrictions. 

b. Requirements for Handling, 

Conveying, and Storing 

Proposed § 112.52 would establish 

requirements for handling, conveying 

and storing soil amendments of animal 

origin. Specifically, we propose in 

§ 112.52(a) that you handle, convey, and 

store any biological soil amendment of 

animal origin in a manner and location 

such that it does not become a potential 

source of contamination to covered 

produce, food-contact surfaces, areas 

used for a covered activity, water 

sources, and water distribution systems. 

As discussed immediately above, 

prolific growth of a human pathogen in 

a potentially competition-poor, nutrientrich, biological soil amendment of 

animal origin could lead to the 

amendment acting as an inoculum that 

spreads microorganisms on any field or 

covered produce growing area to which 

the amendment may be applied, as well 

as to food-contact surfaces, areas used 

for covered activities, water sources, 

and water distribution systems. To 

fulfill the proposed requirement in 

§ 112.52(a), we would expect you to take 

specific measures to ensure that 

untreated biological soil amendments of 

animal origin do not contaminate 

covered produce directly or indirectly 

through contact with food contact 

surfaces, areas in which covered 

activities are conducted, water sources, 

or distribution systems. Such measures 

may include, for example, separation of 

treated and untreated manure (or other 

biological soil amendments of animal 

origin) and preventing any leachate 

originating from untreated biological 

soil amendments of animal origin from 

becoming a source of contamination for 

source water or water distribution 

systems (Ref. 173). 

As discussed in the QAR, any 

untreated biological soil amendment of 

animal origin that contaminates a food 

contact surface could be a source of 

further cross-contamination to covered 

produce. Moreover, a biological soil 

amendment of animal origin that has 

been treated by a composting process 

may still have a residual population of 

pathogens, since composting is not a 

complete kill step (Ref. 174); therefore, 

such biological soil amendments require 

a multiple hurdle approach to minimize 

the likelihood of introducing pathogens 

to a field on which they are applied. If 

composted material contaminates a food 

contact surface, the combined presence 

of available nutrients plus any 

pathogens that may have survived the 

composting process present a potential 

source of contamination for any covered 

produce that comes in contact with the 

contaminated food contact surface. 

Further, a fully heat-treated biological 

soil amendment of animal origin, while 

reasonably likely to be free of 

pathogens, may act as a source of 

nutrients for pathogens that might 

contaminate the food contact surface, 

thereby allowing them to multiply and 

pose a likelihood of contaminating any 

produce coming in contact with the 

food contact surface. 

As proposed, § 112.52(b) requires that 

you handle, convey and store any 

treated biological soil amendment of 

animal origin in a manner and location 

that minimizes the likelihood of it 

becoming contaminated by an untreated 

or in-process biological soil amendment 

of animal origin. This proposed 

requirement is necessary because a 

biological soil amendment of animal 

origin previously treated to reduce 

pathogens can become re-contaminated 

by pathogens if not properly handled 

and stored (Ref. 175). For example, if 

you fully compost manure produced by 

your cows with the intent of using it to 

amend a field you use to grow covered 

produce, proposed § 112.52(b) would 

require that you handle, convey, and 

store the fully composted manure in a 

manner and location to prevent its 

contamination by raw manure, or by 

manure in the composting process. This 

requirement is critical because bacterial 

pathogens, such as E. coli O157:H7 or 

Salmonella spp., if allowed to recontaminate finished compost, may 

grow and spread to populations that 

present a significant likelihood of 

contaminating any environment in 

which the soil amendment is used (Ref. 

171). An example of crosscontamination may include turning a 

pile of manure that is in the process of 

composting with a front-end loader, and 

then proceeding to handle fully 

composted humus from a mature pile 

with the same equipment. To avoid 

such cross-contamination, you could 

clean the front-end loader between 

manipulating an incomplete pile and 

manipulating a mature pile; move 

‘‘downstream,’’ beginning with sanitary 

equipment and manipulating the most 

mature piles first, then proceeding to 

less mature piles; or designate certain 

equipment to only be used on piles of 

a certain maturity; or adopt other 

strategies that meet the same goals. 

Proposed § 112.52(c) would require 

you to handle, convey, and store any 

biological soil amendment of animal 

origin that has become contaminated 

(for example, by an untreated or inprocess biological soil amendment of 

animal origin) as if it was untreated. In 

other words, a treated biological soil 

amendment of animal origin that has 

become contaminated would need to be 

applied in accordance with the 

application and interval restrictions of 

proposed § 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 origin becomes 

unintentionally contaminated (e.g., from 

runoff from an untreated biological soil 

amendment of animal origin), you 

would either need to treat that material 

in accordance with an option in 

proposed § 112.54 and then apply it in 

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accordance with the applicable 

requirements in § 112.56 for the 

treatment used, or you would have to 

follow the application requirements for 

untreated biological soil amendments of 

animal origin in proposed § 112.56(a)(1) 

for the contaminated material. 

c. Prohibition Regarding Use of Human 

Waste 

Proposed § 112.53 would prohibit the 

use of human waste for growing covered 

produce, except sewage sludge biosolids 

used in accordance with the 

requirements of 40 CFR Part 503, 

subpart D, or equivalent regulatory 

requirements. Human waste has a high 

probability of containing multiple 

diverse human pathogens, including 

bacteria, parasites and viruses, at 

potentially very large populations, thus 

presenting a significant likelihood of 

harboring and spreading these various 

microbiological hazards (Ref. 92). We 

recognize that an application of 

untreated human waste could occur 

outside of your control (for example, as 

a run-off event from adjacent land not 

under your control), or may have 

occurred as a previous use of land 

before you took possession. If you know 

or have reason to believe such an event 

has occurred, we would expect you to 

take measures reasonably necessary to 

minimize the risk of serious adverse 

health consequences or death based on 

your specific circumstances. Such 

measures may include crop diversion, 

reconditioning or destruction, and/or 

land remediation, or other comparable 

methods. 

Under 40 CFR part 503 subpart D 

(§ 503.30, 31, 32 and 33), the U.S. EPA 

requires that the application of sewage 

sludge biosolids to fields in which food 

or feed crops are grown adhere to 

certain pathogen reduction 

requirements, and use certain vector 

attraction reduction options. Depending 

on which options are implemented, 

there are different ranges of wait periods 

between application of the soil 

amendment, and the harvest of the crop 

grown. For example, if an untreated 

human waste (i.e., equivalent to 

domestic septage: ‘‘Liquid or solid 

material removed from a septic tank, 

cesspool, portable toilet’’) (40 CFR 

503.9(f)), is applied to a field used to 

produce a food crop, then ‘‘Food crops 

with harvested parts that touch the 

sewage sludge/soil mixture and are 

totally above the land surface shall not 

be harvested for 14 months after 

application of sewage sludge’’ (40 CFR 

503.32(c)(1), cross-referencing § (b)(5) of 

the same section). We agree these 

standards are appropriate for protecting 

public health and, therefore, we are not 

proposing to implement further 

restrictions. Our proposed definition of 

agricultural teas, discussed in section 

V.A.2.b.iii. of this document, would 

provide that agricultural teas are not 

made from any form of human waste 

because doing so would not be 

permissible under 40 CFR part 503 

subpart B. 

d. Acceptable Treatment Processes 

Although there is great variability in 

available data on pathogen survival in 

animal manure depending on the type 

and source of manure in question, the 

location and environment under which 

the manure is stored, and numerous 

other factors (Ref. 176. Ref. 177. Ref. 

178) there are data to suggest it is 

reasonable to expect that, given the 

proper conditions, pathogens in certain 

animal manures may survive for months 

(Ref. 179), years (Ref. 180), or even 

indefinitely (Ref. 174). Because the use 

of soil amendments that contain 

materials of animal origin poses a 

significant likelihood of contaminating 

the growing environment and covered 

produce with human pathogens, we 

have tentatively concluded that such 

materials used as a soil amendment 

require some level of treatment, or other 

risk-reducing steps (such as application 

restrictions), for use in the growing of 

covered produce. Proposed § 112.54(a)– 

(c) would establish acceptable treatment 

processes for a biological soil 

amendment of animal origin when 

applied in the growing of covered 

produce, along with associated 

microbial standards against which they 

must be validated in proposed § 112.55. 

A validated process, when properly 

implemented and monitored, would be 

expected to meet the listed microbial 

standards and thereby reduce the 

likelihood of hazards associated with 

biological soil amendments of animal 

origin from contaminating covered 

produce. The microbial standards in 

proposed § 112.55 are not meant as lotby-lot microbial testing requirements. 

Instead, the person applying the 

treatment process would need to 

monitor the physical parameters of the 

process (e.g., temperature of a compost 

pile) to ensure that they meet the 

conditions under which the process was 

validated. In addition, proposed 

§ 112.54 would provide that the 

resulting biological soil amendments 

must be applied in accordance with the 

applicable 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 microbial 

hazards being present in the applied soil 

amendment must also increase. That is, 

for an application practice that is more 

likely to result in the amendment 

contacting covered produce (e.g., 

broadcast application of a soil 

amendment vs. subsurface soil 

amendment injection for the same crop, 

or in-row application of a soil 

amendment for a row crop vs. in-row 

application for a tree crop), it is more 

important to have stricter controls for 

known or reasonably foreseeable 

microbial hazards in the applied soil 

amendment than for another 

amendment whose application practice 

is less likely to result in the amendment 

coming into contact with covered 

produce. Therefore, proposed § 112.54 

consists of multiple acceptable options 

for the treatment of soil amendments 

and corresponding standards against 

which they are to be validated (as 

further described in § 112.55). These 

proposed treatment options were 

designed to be flexible to allow you to 

determine what your operation’s needs 

are, and select the option that best fits 

those needs. In developing these 

proposed requirements, we have taken 

into account the wide variation 

presented by different feedstocks used 

in preparing biological soil amendments 

of animal origin, the diversity of 

commodities, and various growing 

regions. In addition, we considered the 

likelihood of contamination posed by 

biological soil amendments of animal 

origin subjected to each of these 

multiple treatment options when 

determining the appropriate application 

requirements, as proposed in § 112.56. 

We have tentatively concluded that the 

use of the physical, chemical, and 

composting treatments 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 form of high-heat treatment 

(cooking) of the biological soil 

amendment of animal origin to kill 

undesirable microorganisms. By 

contrast, chemical treatments usually 

involve greatly altering the pH of a 

biological soil amendment of animal 

origin, to the point that undesirable 

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microorganisms do not survive. In a 

study treating chicken manure with 

ammonia to reach high (alkaline) pH 

levels, a 3 to 4 log decrease of generic 

E. coli was observed over 6 days at 20°C, 

and drying manure to 10% moisture 

content and exposing it to ammonia gas 

(1% of manure wet weight) reduced 

pathogen load by 8 log (99.999999% 

reduction) (Ref. 181). To perform either 

physical or chemical treatments, the 

feedstock is generally placed in a large 

treatment container, and large amounts 

of energy are required in order to 

initiate the treatment. These factors 

alone make these forms of treatment 

impracticable for many farms. While 

such treatments can be expected to have 

a strong lethal impact on 

microorganisms present in the 

feedstock, they do not always result in 

complete elimination of pathogens. For 

example, chicken manure may be heattreated to create a dried, pelleted 

material that is functionally sterile due 

to the high heat used during production; 

however, it has been observed that if the 

heat treatment is not uniform, the end 

product may still harbor human 

pathogens and pose a likelihood of the 

material being re-colonized by the 

microbial pathogen, leading to the 

possible contamination of any covered 

produce to which it is applied (Ref. 

115). 

Biological soil amendments of animal 

origin may also be prepared by 

combining multiple treatments, either 

alone or in combination. For example, a 

single feedstock may be heat-treated 

(physical) while also drenched in strong 

ammonia (chemical) to acidify the 

material (Ref. 182). Alternatively, 

feedstock may first be composted and 

then treated by heat to further reduce 

pathogens, effectively pasteurizing the 

material, as is common practice in the 

production of mushroom growth media 

(Ref. 183). These systems have been 

shown to be highly effective when 

proper controls are in place and 

monitored, but they also require 

significant inputs and capital 

investments. 

Proposed § 112.54(a) would establish 

that a scientifically valid controlled 

physical process (e.g., thermal), 

chemical process (e.g., high alkaline 

pH), or combination of scientifically 

valid controlled physical and chemical 

processes that have been demonstrated 

to satisfy the microbial standard in 

§ 112.55(a) for Listeria monocytogenes, 

Salmonella spp., and E. coli O157:H7 is 

a treatment option for biological soil 

amendments of animal origin. This 

standard is currently used by the 

mushroom industry, which utilizes a 

two-phase process consisting of a 

composting treatment that meets the 

composting standard proposed in 

§ 112.54(c) followed by a subsequent 

heating process that meets the microbial 

standard 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 

significantly reduce or eliminate known 

or reasonably foreseeable microbial 

hazards in biological soil amendments 

of animal origin, and would constitute 

the lowest expected likelihood of any of 

the proposed treatment options. We 

have also tentatively concluded that a 

biological soil amendment of animal 

origin that has been treated to this 

standard would be appropriate for use 

when the likelihood for contamination 

of covered produce is the highest, such 

as the substrate (growth media) used for 

growing mushrooms and some sprouts. 

Therefore, as provided in proposed 

§ 112.56(a)(2) and discussed further in 

section V.F.2 f of this document, any 

biological soil amendment of animal 

origin treated to this standard would 

have the fewest limitations on its 

application. 

Proposed § 112.54(b) would establish 

that a scientifically valid controlled 

physical process, chemical process, or 

combination of scientifically valid 

controlled physical and chemical 

processes, that has been demonstrated 

to satisfy the microbial standard in 

§ 112.55(b) for Salmonella and fecal 

coliforms is a treatment option for 

biological soil amendments of animal 

origin. We have tentatively concluded 

that a treatment meeting this standard 

would significantly reduce known or 

reasonably foreseeable microbial 

hazards in biological soil amendments 

of animal origin leading to minimal 

likelihood of contamination. A 

biological soil amendment of animal 

origin that has been treated to this 

standard would be appropriate for use 

when there is a high likelihood that the 

soil amendment will come into contact 

with covered produce. Moreover, as 

provided in proposed § 112.56 and 

discussed further in section V.F.2.f of 

this document, any biological soil 

amendment of animal origin treated to 

this standard would have minimal 

limitations on its application. 

Proposed § 112.54(c) would establish 

that a scientifically valid controlled 

composting process that has been 

demonstrated to satisfy the microbial 

standard in § 112.55(b) for Salmonella 

and fecal coliforms is a treatment option 

for biological soil amendments of 

animal origin. Two specific 

scientifically valid controlled 

composting processes that could be 

used to meet the requirements of 

proposed § 112.54(c) are provided: (1) 

Static composting that maintains 

aerobic (i.e., oxygenated) conditions at a 

minimum of 131 °F (55 °C) for 3 days 

and is followed by adequate curing, 

which includes proper insulation; and 

(2) turned composting to maintain 

aerobic conditions at a minimum of 

131 °F (55 °C) for 15 days, with a 

minimum of five turnings, and is 

followed by adequate curing, which 

includes proper insulation. These two 

composting processes are currently 

considered by the U.S. Environmental 

Protection Agency as Processes to 

Further Reduce Pathogens (Appendix B 

to 40 CFR part 503, part B.1). Both are 

recommended for use by the U.S. 

Department of Agriculture’s 

Agricultural Research Service (Ref. 184), 

Natural Resources Conservation Service 

(Ref. 97), and National Organic Program 

(7 CFR part 205), and both are 

commonly accepted practices within the 

industry (Ref. 185). While there is 

robust discussion in the literature on 

times, temperatures, and other 

conditions (pH, moisture, oxygen levels, 

etc.) needed for significant reductions 

(albeit not elimination) of human 

pathogens in cattle, sheep and chicken 

manures, it is clear that composting 

cannot be considered as a pathogenelimination step because of the many 

variables that can affect the efficacy of 

the composting process (e.g., feedstock 

mixtures, climatic conditions, and 

various other physio-chemical 

parameters) (Ref. 174). These limits are 

currently used as composting endpoints 

by other federal agencies (40 CFR 503) 

States (Ref. 90. Ref. 164. Ref. 163), and 

industry (Ref. 31). 

Composting is generally the least 

expensive method with the lowest 

capital investment requirement, and if 

properly managed, can be expected to 

significantly reduce pathogen 

populations in feedstock materials (Ref. 

186). As noted in the Produce Safety 

Project Issue Brief on Composting of 

Animal Manures, composting has been 

shown to reduce the overall 

concentration of nitrogen in the soil 

amendment, which poses a concern for 

some farmers, but it also has been 

demonstrated that the remaining 

nitrogen is both in a more bio-available 

state (i.e., more easily utilized by plants) 

and will persist in the environment for 

a longer time (therefore providing 

nutrients to plants for a longer time) 

(Ref. 27). Composting leaves much of 

the native microflora intact (Ref. 187). 

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Proper composting is not difficult for 

most operations, but it does require a 

labor commitment to ensure conditions 

are met and maintained to achieve the 

desired effect. Some of the most critical 

elements of composting include proper 

stacking of a pile, proper aeration and 

turning, and ensuring the pile attains 

the proper temperature and is allowed 

to cool (cure) for an adequate time (Ref. 

27). There are currently no federally 

mandated composting standards for 

food safety. The USDA/NOP offers 

standards that are meant to maximize 

soil fertility in 7 CFR 205.203 (these are 

required to achieve ‘‘USDA Certified 

Organic’’ status, but otherwise are 

recommendations only), and EPA 

standards in 40 CFR part 503 are 

specific to sewage sludge, not animal 

manures. While these standards were 

not developed for food safety, several 

studies suggest that they would be 

appropriate for use as food safety 

measures (Ref. 27). Proper handling and 

storage during and after composting to 

avoid cross-contamination of cured 

product and in-process or raw product 

is critical, as discussed in section 

V.F.2.b of this document above 

regarding proposed § 112.52 of this rule. 

Other important factors in proper 

composting (such as the carbon to 

nitrogen ratio of the feedstock (C:N), the 

moisture content of the pile, the 

reaction to high cellulose-content 

material (i.e., plant material such as 

straw or vegetative waste), and the 

specifics of the beneficial microbial 

content will vary depending on the 

feedstock (Ref. 187). The person who 

manages the composting process would 

also need to consider such factors as the 

moisture content, pH, carbon to nitrogen 

ratio (C:N), and feedstock to achieve the 

microbial standards set forth in 

proposed § 112.55. Many resources are 

available that discuss these details, such 

as the USDA NRCS handbook (Ref. 97). 

When composting processes are carried 

out in an incorrect manner, the organic 

matter in the finished product remains 

poorly stabilized and recontamination is 

more likely to occur, which can 

potentially result in the compost 

becoming a source of pathogens that 

could contaminate the field to which it 

is applied and any crops that are grown 

in the amended soil (Ref. 165). 

As noted in the Produce Safety Project 

Issue Brief on Composting of Animal 

Manures, adequate curing, including 

proper insulation (usually consisting of 

around one foot thick of insulating 

material, e.g., hay, straw, finished 

compost) is included as part of this 

proposed requirement, because curing is 

an important step in the composting 

process to further reduce the levels of 

pathogens, complete the chemical 

reactions of composting, and mitigate 

the impact that incomplete turning 

(creating temperature stratification 

within an active pile) would have on 

composting efficacy (Ref. 27). Proper 

insulation serves as a layer of protection 

from external influences (e.g., 

temperature changes, wild animal 

encroachment). 

The treatment processes proposed in 

§ 112.54(c), paragraphs (1) and (2), may 

not be the only means of achieving 

adequate composting to meet 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 composting protocols other 

than those specified in § 112.54(c)(1) 

and (2), if they meet the microbial 

standards for validation for composting 

in proposed § 112.55(b). Proposed 

§ 112.54(c)(3) allows for the use of other 

scientifically valid, controlled 

composting processes, provided you 

satisfy the requirements of § 112.12, 

including that the alternative has been 

demonstrated to satisfy the microbial 

standard 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 processes to be 

conducted to meet the microbial 

standards presented; therefore, any 

scientifically valid controlled physical, 

chemical, or combination of physical 

and chemical processes that has been 

demonstrated to satisfy the relevant 

microbial standard in either § 112.55(a), 

or § 112.55(b) will meet the 

requirements of those subparts. 

e. Microbial Standards Applicable to 

Treatment Processes 

Proposed § 112.55 establishes 

microbial standards applicable to the 

treatment processes in § 112.54. 

Proposed § 112.55(a) would provide 

microbial standards for the treatment 

process in proposed § 112.54(a). It 

would require: (1) L. monocytogenes to 

be not detectable using a method that 

can detect one colony forming unit 

(CFU) per five gram analytical portion; 

(2) Salmonella spp. to be less than 3 

most probable number (MPN) per four 

grams of total solids (dry weight basis); 

and (3) E. coli O157:H7 to be less than 

0.3 MPN per 1 gram analytical portion. 

As discussed immediately above 

regarding proposed § 112.54(a), these 

standards are the most stringent and 

meant for applications in which a 

biological soil amendment of animal 

origin would otherwise pose the greatest 

likelihood of transferring a known or 

reasonably foreseeable hazard to a 

covered produce commodity. These 

standards would also be useful if you 

wanted to use a biological soil 

amendment of animal origin with the 

least amount of application restrictions 

available under proposed § 112.56. As 

previously noted, these microbial 

standards are currently used by the 

mushroom industry for growth media 

and reduce over 7 log CFU/g of Listeria, 

Salmonella, and E. coli O157:H7 to 

undetectable levels (Ref. 183). 

Proposed § 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 section would require less than 

3 MPN Salmonella spp. per 4 grams of 

total solids (dry weight basis), and less 

than 1,000 MPN fecal coliforms per 

gram of total solids (dry weight basis). 

These limits are currently used as 

composting validation endpoints by 

EPA (40 CFR 503), some States (Ref. 90. 

Ref. 164. Ref. 163), and industry (Ref. 

31). Ohio and California (Ref. 163. Ref. 

164), industry (Ref. 31) and other 

nations such as Canada and the United 

Kingdom (Ref. 27) use both of these 

criteria, while EPA and Florida (Ref. 92. 

Ref. 90) allow for either criteria to be 

used. As noted in the Produce Safety 

Project Issue Brief on Composting of 

Animal Manures, the EPA requirement 

of validation with either Salmonella 

spp. or fecal coliforms is based on the 

observation that reduction in fecal 

coliforms is well correlated to reduction 

in Salmonella spp. when biosolids are 

composted (Ref. 27). However, we 

tentatively conclude that satisfying both 

of these criteria is necessary to 

significantly minimize known or 

reasonably foreseeable hazards when 

combined with the applicable 

application requirements in proposed 

§ 112.56. Monitoring the relative levels 

of indicator microbes such as fecal 

coliforms, which are predominantly E. 

coli in manures and freshly mixed 

compost, is advantageous in that they 

are abundant in manure. In the absence 

of a reliably present pathogen, fecal 

coliforms are useful to validate the 

efficiency of the thermophilic 

composting process (Ref. 27). 

Additionally, E. coli, the primary fecal 

coliform in manure, has been 

documented to be a good indicator of 

the inactivation of E. coli O157:H7 (Ref. 

168). Validating solely with Salmonella 

spp. is not sufficiently protective or 

useful for validating the efficiency of a 

thermophilic composting process, since 

Salmonella spp. cannot be assumed to 

be present in all composting feedstock 

materials. On the other hand, 

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Salmonella spp. is the most common 

microbiological hazard associated with 

fresh produce (Ref. 3). As such, 

validating with fecal coliforms and 

Salmonella spp. not only assures the 

efficacy of the thermophilic composting 

process but also assures significant 

reduction of the pathogen Salmonella 

spp. when commonly used compost 

feedstocks are used that are likely 

sources of Salmonella spp. (e.g., cattle 

and poultry manure) (Ref. 188). We seek 

comment on these proposed microbial 

standards and potential alternatives. 

We do not intend this proposed 

provision to require that farms test their 

treated biological soil amendments for 

compliance with the microbial 

standards. Rather, we intend this 

provision to provide the standard 

against which treatment processes must 

be validated. Farms would be able to 

use treatment processes that are 

validated to meet the relevant microbial 

standard in this section without needing 

to test the end products of their 

treatments to confirm that the microbial 

standard was achieved. 

f. Application Requirements and 

Minimum Application Intervals 

Proposed § 112.56 establishes the 

application requirements and minimum 

application intervals applicable to 

biological soil amendments of animal 

origin. Proposed § 112.56(a) would 

establish a requirement that, except as 

provided in subparagraph (b), any 

biological soil amendment of animal 

origin that you use must be applied with 

the application method requirements 

and minimum application intervals 

specified in the table presenting 

proposed § 112.56(a)(1)–(4). The 

different application method 

requirements and intervals for biological 

soil amendments of animal origin are 

presented so that you may determine 

the amendment, application, and 

interval that is most appropriate for 

your situation, based on the expected 

likelihood of contaminating produce by 

use of the biological soil amendment of 

animal origin you plan to use. 

In developing the application 

methods requirements of proposed 

§ 112.56(a)(1)–(4), we first considered 

specifications of each type of biological 

soil amendment of animal origin, and 

then considered the likelihood that the 

soil amendment will come into contact 

with covered produce. For example, 

those biological soil amendments of 

animal origin treated with a process or 

processes capable of consistently and 

reliably reducing or eliminating 

pathogens as per § 112.54(a) do not have 

any application 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 application 

that minimize the potential for the 

treated biological soil amendment of 

animal origin to contact covered 

produce during and after application 

(proposed § 112.56(a)(3), (a)(4)(ii)) and 

also allow for pathogen die-off when it 

is reasonably likely that covered 

produce will contact soil after 

application of the soil amendment 

(proposed § 112.56(a)(4)(i)). 

Requirements would include the 

application of untreated biological soil 

amendments of animal origin in 

situations where it is reasonably likely 

that covered produce will contact the 

soil after application of the soil 

amendment (§ 112.56(a)(1)(i)), where the 

amendment would be permitted to be 

applied in a manner that minimizes the 

potential for contact with covered 

produce after application, but with an 

additional food safety measure that it 

can be applied only in a manner that 

does not contact covered produce 

during application and using a 

minimum application interval of 9 

months. By contrast, in situations where 

covered produce will not contact the 

soil, (§ 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 must be 

applied in a manner that does not 

contact covered produce during 

application and minimizes the potential 

for contact with covered produce after 

application and the minimum 

application interval is nine (9) months. 

This provision would apply to any 

situation in which the covered produce 

is reasonably likely to contact the soil 

after application of the soil amendment. 

Proposed § 112.56(a)(1)(ii) requires that 

if you apply a biological soil 

amendment of animal origin that is 

untreated, and the material is applied in 

a manner that does not contact covered 

produce during or after application, 

there is no minimum application 

interval. This provision would apply to 

any situation in which the covered 

produce will not contact the soil after 

application of the soil amendment. The 

specific microbial populations of raw 

manure are generally unknown, but can 

be expected to be very high, and are 

likely to include zoonotic 

microorganisms that pose a food safety 

hazard (such as Salmonella spp. up to 

10∧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 agricultural tea additives 

is also high (Ref. 142). Given the desire 

to both allow for the continued use of 

raw manure, agricultural teas containing 

agricultural tea additives, and other 

untreated biological soil amendments of 

animal origin; and to minimize the risk 

of known and reasonably foreseeable 

hazards, we have tentatively concluded 

that we should require that untreated 

biological soil amendment of animal 

origin (including raw manure) applied 

in the growing of covered produce 

should either first be treated to reduce 

microbial food safety hazards; or if the 

covered produce is reasonably likely to 

contact the soil after application of the 

soil amendment, the untreated soil 

amendment should be applied in a 

manner that keeps it from coming into 

contact with covered produce during 

application, minimizes the potential for 

contact after application, and allows for 

the die-off of pathogens; and if the 

covered produce will not contact the 

soil after application of the soil 

amendment, the untreated soil 

amendment should be applied in a 

manner that keeps it from coming into 

contact with covered produce during 

and after application. In the case of 

agricultural teas containing agricultural 

tea additives, we tentatively conclude 

that because additional treatment is not 

an option they should be applied in the 

same manner as untreated biological 

soil amendments of animal origin. 

Proposed § 112.56(a)(1)(i) would 

therefore establish such restrictions on 

the manner of application for these 

materials when they are reasonably 

likely to come in contact with covered 

produce after application, as well as a 

minimum application interval (waiting 

period) of nine (9) months from the 

application of untreated biological soil 

amendments of animal origin to the 

harvest of covered produce. On the 

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other hand, under proposed 

§ 112.56(a)(1)(ii), untreated biological 

soil amendments of animal origin would 

be permitted for use with no minimum 

waiting period when the soil 

amendment is applied in a manner that 

does not contact covered produce 

during or after application. We 

investigated the potential for survival of 

many enteric pathogens of public health 

concern (Ref. 190. Ref. 92) and 

determined that across various 

pathogens and their potential 

environments, pathogen survival and 

die-off time in soils amended with raw 

manures are extremely varied. One 

consistency across many trials was an 

observed rapid early die off of many 

pathogens, followed by a prolonged 

survival of the remaining low 

populations (Ref. 191. Ref. 104. Ref. 

192). It is unclear in the existing 

literature at what point the population 

is low enough to minimize the potential 

for contamination of covered produce; it 

is reasonable to suggest that once 

pathogen populations fall below 

detection limits, their risks are 

minimized. 

Some of the longest survival times 

involved organisms initially present at 

very high initial populations (e.g., E. 

coli O157:H7 in sheep manure (Ref. 177) 

surviving for 21 months) or involved 

certain pathogens such as encysting 

parasites (Cryptosporidium parvum 

cysts surviving for over a year (Ref. 193) 

or the eggs of parasitic flatworms 

(Ascaris ova surviving for over 15 years 

(Ref. 174)). Some enteric pathogens are 

reported to be more resilient to 

deleterious effects of the environment 

than others (most notably, Salmonella 

seems better attuned for survival outside 

of a host than does E. coli O157:H7 (Ref. 

194)) and those microorganisms that 

produce spores are especially hardy. 

Basing all manure application standards 

on these extreme cases would be 

unnecessary. The majority of survival 

studies showed that most enteric 

pathogens of public health importance, 

under the most common conditions, 

would not survive in the soil past 1 year 

(Ref. 190). This includes organisms less 

commonly associated with fresh 

produce, such Cryptosporidium, 

Giardia, and Ascaris (parasitic flat 

worms). Organisms most commonly 

associated with fresh produce outbreaks 

(such as E. coli, Salmonella and Listeria) 

are unlikely to survive at detectable 

population levels in soil past 270 days 

(Ref. 181. Ref. 182. Ref. 183). Therefore, 

we tentatively conclude that utilizing a 

9-month waiting period between the 

application of untreated biological soil 

amendment of animal origin and the 

harvest of covered produce would be 

protective for the preponderance of 

environments in situations where 

covered produce is reasonably likely to 

contact the soil after application of 

untreated biological soil amendments of 

animal origin. This is not inconsistent 

with the 12-month restriction used by 

some segments of the produce industry 

(Ref. 31). Where the soil amendment 

does not contact covered produce either 

during or after application, we do not 

believe that a minimum application 

interval is reasonably necessary to 

prevent the introduction of known or 

reasonably foreseeable hazards into 

covered produce. Therefore, proposed 

§ 112.56(a)(1)(ii) provides for the option 

to use untreated biological soil 

amendments of animal origin with no 

minimum waiting period, provided the 

soil amendment is applied in a manner 

that does not contact covered produce 

during or after application. We seek 

comment on the proposed waiting 

period. 

One study, which specifically 

addressed considerations of microbial 

survival in soil and resulting transfer on 

to produce grown in the soil, suggested 

that, under ideal conditions for survival, 

organisms could survive for greater than 

226 days (Ref. 191). The study was 

performed in the Southeastern U.S. 

(Georgia) and, therefore, is unlikely to 

reflect climatic conditions prevalent in 

other areas of the country, including the 

potential for the ground to freeze during 

winter. While microbes present on 

frozen ground can be expected to be 

reduced in population more rapidly 

(Ref. 195), those surviving are likely to 

persist for a longer time period in a state 

of dormancy (Ref. 196). The dormancy 

of microorganisms also means that they 

will pose a likelihood of contamination 

for greater periods of time, creating a 

wider window of opportunity for 

covered produce to become 

contaminated. We request comment on 

whether and how, as an additional 

requirement for the application of 

untreated biological soil amendments of 

animal origin, the time period when the 

soil is frozen should count toward the 

proposed application interval. Further, 

it has been noted that rapid freeze-thaw 

cycles of weather may cause more rapid 

die-off rates of pathogens present in 

soils (Ref. 197). We request comment on 

the impact that freeze-thaw cycles may 

have on use of biological soil 

amendments of animal origin. 

Proposed § 112.56(a)(2) would 

establish that the use of a biological soil 

amendment of animal origin treated by 

a scientifically valid controlled physical 

or chemical process, or combination of 

scientifically valid controlled physical 

and chemical processes, in accordance 

with the requirements of § 112.54(a) to 

meet the microbial standard in 

§ 112.55(a), would have no application 

method restrictions and no minimum 

application interval. At this level of 

microbial reduction, a treated biological 

soil amendment of animal origin can be 

expected to present negligible 

likelihood of contamination. Therefore, 

we have tentatively concluded that no 

further action is necessary for the safe 

use of such a product in conjunction 

with covered produce. 

For example, unlike other biological 

soil amendments of animal origin, the 

nature of a growth medium that is a 

biological soil amendment of animal 

origin and is used for growing 

mushrooms, some sprouts and similarly 

grown produce, makes contact between 

the covered produce and the growth 

medium inevitable. This precludes the 

ability to utilize application restrictions 

as a meaningful measure to minimize 

the likelihood of pathogen 

contamination of covered produce 

through a multiple-hurdle approach, 

that would allow for the use of less 

robust treatment processes in 

combination with application manner 

restrictions. Therefore, we tentatively 

conclude that, such growth media must 

be treated by a scientifically valid 

controlled physical or chemical process, 

or combination of scientifically valid 

controlled physical and chemical 

processes, in accordance with the 

requirements of § 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 chemical processes, in accordance 

with the requirements of § 112.54(b) to 

meet the microbial standard in 

§ 112.55(b) be used in a manner that 

minimizes the potential for contact with 

covered produce during and after 

application, with no minimum 

application interval. We have 

tentatively concluded that treating a 

biological soil amendment of animal 

origin to meet the standards of 

§ 112.54(b) would significantly decrease 

the population of any microorganisms of 

public health significance that may have 

previously been present. Further, the 

proposed application restriction of 

minimizing direct contact of the 

amendment with the edible portion of 

covered produce would further reduce 

the likelihood of any remaining 

microorganisms in a treated soil 

amendment contaminating covered 

produce, as well as reduce the 

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likelihood that the soil amendment 

would provide a nutrient source for any 

microorganisms of public health 

significance already present on covered 

produce. We have tentatively concluded 

that the treatment of the biological soil 

amendment of animal origin, combined 

with minimizing its contact with 

covered produce would adequately 

reduce the likelihood of contamination 

and subsequent severe adverse health 

consequences or death. We have also 

tentatively concluded that, with the 

likelihood already minimized, it is 

unnecessary to implement a further 

burden by proposing a minimum 

application interval for soil 

amendments treated by physical or 

chemical processes, or combinations of 

such processes, to the standards of 

§ 112.54(b). For example, chicken 

manure pellets that have been treated by 

a controlled high-temperature process 

according to a protocol that has been 

validated to meet the standards in 

proposed § 112.54(b) could be used as 

an in-furrow side-dress for leafy greens 

immediately before harvest. However, in 

this same example, the application 

could not be conducted by overhead 

broadcast spreading, since this method 

would not minimize contact of the 

biological soil amendment with the 

covered produce. 

Proposed § 112.56(a)(4)(i) would 

establish requirements for use of a 

biological soil amendment of animal 

origin treated by a composting process 

in accordance with the requirements of 

§ 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 and with a minimum 

application interval of 45 days. This 

provision would apply to situations in 

which the covered produce is 

reasonably likely to contact the soil after 

application of the soil amendment. 

Proposed § 112.56(a)(4)(ii) requires 

that if you apply a biological soil 

amendment of animal origin treated by 

a composting process in accordance 

with the requirements of § 112.54(c) to 

meet the microbial standard in 

§ 112.55(b), and the material is applied 

in a manner that does not contact 

covered produce during or after 

application, there is no minimum 

application interval. This provision 

would apply to any situation in which 

the covered produce will not contact the 

soil after application of the soil 

amendment. Although the microbial 

standards and application restrictions 

for biological soil amendments of 

animal origin treated to meet the 

requirements of proposed § 112.56(a)(4) 

are the same as those described 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 

tentatively concluded that process 

controls during chemical or physical 

treatments can be expected to be less 

prone to failure than process controls 

for composting. For example, heat 

treatments are often conducted in 

enclosed heat-treatment chambers (i.e., 

ovens), often with various means of 

agitation (such as stirring rods, etc.), 

that can be accurately monitored and 

controlled to reach the required 

treatment conditions throughout the 

material being treated. Conversely, 

composting usually occurs outdoors, is 

exposed to fluctuating environmental 

pressures and wildlife activity, is not 

homogeneous in nature and prone to 

having ‘‘cold-spots’’ that are not 

completely treated (even with proper 

turning) (Ref. 174). In general, in 

composting, there is a higher likelihood 

of having a systems failure, which is 

also more likely to go undetected, 

should it occur. Composting may result 

in a treated biological soil amendment 

of animal origin that may continue to 

harbor human pathogens of food safety 

concern (Ref. 174), although any such 

hazards that may be present can be 

expected to be present at low 

populations and unlikely to survive for 

extended periods under normal 

environmental conditions after 

application. Examples of a system 

failure that may occur during 

composting, but would not be expected 

during a thermal or physical treatment, 

could include animal intrusion, 

incomplete turning, or reduced 

efficiency of composting due to 

environmental or climatic conditions 

(e.g., heavy rainfall or excessive cloud 

cover reducing the temperature of the 

pile or portions of the pile). Therefore, 

we propose to impose an additional 

mitigation measure in situations where 

covered produce is reasonably likely to 

contact the soil after application of 

biological soil amendments of animal 

origin treated by composting by 

requiring a minimum application 

interval of 45 days. This time period has 

been shown to be effective when the 

population of the pathogen is minimal 

(Ref. 92. Ref. 91) (Ref. 198), as can be 

expected of a fully composted biological 

soil amendment of animal origin. This 

multiple hurdle approach and time 

interval has also been utilized in a 

current industry standard (Ref. 31). 

Where a biological soil amendment of 

animal origin does not contact covered 

produce either during or after 

application, we do not believe that a 

minimum application interval is 

reasonably necessary to prevent the 

introduction of known or reasonably 

foreseeable hazards into covered 

produce. Therefore, proposed 

§ 112.56(a)(4)(ii) provides for the option 

to use a biological soil amendment of 

animal origin treated by composting 

with no minimum waiting period, 

provided the soil amendment is applied 

in a manner that does not contact 

covered produce during or after 

application. We seek comment on the 

appropriateness of the proposed 

application period intervals. 

We have not proposed any provisions 

specific to the status of spent mushroom 

mulch (growth media already used in 

the production of mushrooms for 

subsequent use as a biological soil 

amendment of animal origin in the 

growing of other covered produce) and 

specifically request comment on how to 

classify its status. The practice of storing 

spent mushroom mulch for subsequent 

use in the growing of covered produce 

is not known to be a likely source of 

introduced contamination because the 

growth media would have been 

previously treated to eliminate 

pathogens (Ref. 62). Therefore, we 

tentatively conclude that spent 

mushroom mulch previously treated (in 

accordance with proposed § 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 

produce without any intervening 

treatment, unless you know or have 

reason to believe it has been otherwise 

contaminated with a hazard or has been 

associated with foodborne illness. We 

tentatively conclude that spent 

mushroom mulch should be considered, 

for the purpose of the application 

requirements in proposed § 112.56, as 

though it has been treated by 

composting, instead of considering it as 

though it has been treated in accordance 

with the most robust chemical/physical 

treatment process (§ 112.54(a)), though 

it would have received such a treatment 

in accordance with proposed § 112.54(a) 

before its use to grow mushrooms. This 

would have the effect of subjecting 

spent mushroom mulch used 

subsequently to grow other covered 

produce to the requirement to minimize 

the potential for contact with covered 

produce during and after application, 

and a minimum application interval of 

45 days. We consider the weathering 

process (the common practice of spent 

mushroom mulch being placed in a field 

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in windrow for further composting over 

the course of several weeks to years) to 

be similar to composting in terms of 

likelihood of introduction of 

contaminants. We request comment on 

this tentative conclusion. 

Under this proposal, you would, in 

most cases, maintain the flexibility to 

choose among a variety of treated and 

untreated soil amendments of animal 

origin based on the commodity being 

grown, growing conditions, and other 

factors relevant to your operation, but 

you would have to consider both the 

method of application (e.g., whether it 

would result in contact between the 

amendment and the produce) and, for 

certain amendments, the interval before 

harvest. We would expect you to 

determine which application method is 

most appropriate for your situation by 

selecting the application method and 

interval restrictions that would coincide 

best with your operation, and then 

purchase or treat a biological soil 

amendment of animal origin that meets 

the corresponding specifications (i.e., 

the first column in the table in 

§ 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 application interval. You 

would accordingly either use a 

controlled physical or chemical 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 covered 

produce during and after application, or 

use composted or untreated biological 

soil amendments of animal origin if you 

can apply them in a manner that 

ensures they do not contact covered 

produce during or after application (for 

example, if you are growing tree crops 

such as oranges, you apply the 

untreated soil amendment without 

causing it to contact the oranges, and 

you do not harvest oranges that have 

been allowed to come into contact with 

the soil after application of the soil 

amendment). Conversely, you may 

determine which application method 

and interval is most appropriate by 

evaluating which specification your 

biological soil amendment of animal 

origin meets, and then apply it 

according to the coinciding application 

method and interval restrictions. If, for 

example, you wish to apply raw manure 

to your field, you would find the 

requirements that apply to raw manure 

in § 112.56(a)(1) and note that, if it is 

reasonably likely that your covered 

produce will come in contact with the 

soil (for example, where almonds are 

harvested by intentionally dropping to 

the ground) after application of the raw 

manure, the use of raw manure is 

restricted to application in a manner 

that does not contact covered produce 

during application and minimizes the 

potential for contact with covered 

produce after application, and may be 

applied no less than 9 months before 

harvest. On the other hand, if you can 

apply the raw manure in a manner that 

ensures it does not contact covered 

produce during or after application, you 

may use it without a minimum 

application interval. Any minimum 

application interval that you use can be 

concurrent with any application 

intervals that you are already required 

to, or voluntarily, apply. For example, if 

you are a USDA-certified organic 

grower, and utilize a 120-day 

application interval for the use of raw 

manure as part of participation in the 

National Organic Program, the proposed 

9-month application interval 

requirement in § 112.56(a)(1)(i) would 

be concurrent, not consecutive, with the 

120 days. Thus, your use of a 9-month 

application interval for raw manure 

would satisfy both this proposed rule 

and the requirements of the National 

Organic Program. As another example, if 

you plan to apply a biological soil 

amendment of animal origin to a field 

of spinach that is nearing harvest for 

fresh market consumption, assuming the 

spinach is reasonably likely to contact 

the soil after application of the soil 

amendment, you could select a 

biological soil amendment of animal 

origin that is heat-treated to meet the 

standards presented in § 112.54(b) (e.g., 

chicken manure pellets), provided that 

you can apply it in a manner that 

minimizes the potential for contact with 

covered produce during and after 

application (e.g., used as a sidedressing), because there would not be an 

application restriction interval with that 

type of biological soil amendment of 

animal origin. If you plan to use manure 

as a biological soil amendment of 

animal origin for the same crop and 

plan to apply the amendment before 

planting, and do not wish to utilize a 

treatment such as described by 

§ 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 biological soil amendment of animal 

origin would only be restricted to 

application in a manner that minimizes 

the potential for contact with covered 

produce during and after application, 

and application at least 45 days prior to 

harvest. 

Proposed § 112.56(b) would establish 

requirements for the use of alternatives 

to the minimum application intervals 

established in paragraphs (a)(1)(a) and 

(4)(a) of proposed § 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 covered produce will 

be adulterated. For example, 

alternatives to the proposed minimum 

application intervals could take into 

account specific characteristics of the 

locality, crop and the agro-ecological 

environment. Such alternatives could 

consider differences in feedstock; 

application methods; and treatment 

methods, especially given the potential 

for new innovations in such methods. In 

any such case, as discussed below, we 

propose in § 112.60(b)(5) that you 

establish and keep documentation of the 

scientific data and information you are 

relying on to support the use of an 

alternative minimum application 

interval. We do not propose that you 

would be required to submit such data 

and information to us for prior approval; 

we do, however, propose the 

requirement that you maintain a record 

of any such data and information for us 

to evaluate upon request. 

h. Records Requirements 

Proposed § 112.60(a) requires that you 

establish and keep records for subpart F 

in accordance with the requirements of 

subpart O of this part. Proposed 

§ 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 any untreated biological 

soil amendment of animal origin 

(including raw manure) or any 

biological soil amendment of animal 

origin treated by composting to a 

growing area and the date of harvest of 

covered produce from that growing area, 

except when covered produce does not 

contact the soil after application of the 

soil amendment. These records would 

be required because the application of 

both raw manure and compost include 

minimum application intervals 

(§ 112.56(a)(1)(i) and (4)(i), 

respectively), so it would enable FDA to 

verify compliance with the application 

intervals associated with raw manure 

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and compost. These records would also 

allow you to keep track of the dates on 

which those biological soil amendments 

of animal origin were applied in order 

to determine when covered produce 

from those growing areas could be 

harvested in compliance with the rule. 

USDA-certified organic growers who 

already maintain records of when 

biological soil amendments of animal 

origin are applied in compliance with 7 

CFR 205.103 would not need to 

duplicate those records to meet the 

requirements of § 112.60(b)(1). 

Proposed § 112.60(b)(2) would require 

documentation (such as a Certificate of 

Conformance) for a treated biological 

soil amendment of animal origin that 

you receive from a third party. We have 

tentatively concluded that the 

information you will need both to verify 

that any biological soil amendment of 

animal origin you purchase for use in 

performing a covered activity is in 

compliance with this subpart F, and to 

inform your decisions on further 

handling, conveying, and storing of the 

purchased biological soil amendment of 

animal origin, includes the following: (i) 

The process used to treat the biological 

soil amendment of animal origin is a 

scientifically valid process that has been 

carried out with appropriate process 

monitoring; (ii) the applicable treatment 

process is periodically verified through 

testing using a scientifically valid 

analytical method on an adequately 

representative sample to demonstrate 

that the process satisfies the applicable 

microbial standard in § 112.55, 

including the results of such periodic 

testing; and (iii) the biological soil 

amendment of animal origin has been 

handled, conveyed and stored in a 

manner and location to minimize the 

likelihood of contamination by an 

untreated or in-process biological soil 

amendment of animal origin. Aspects (i) 

and (iii) of this proposed requirement 

reflect information that you would have 

if you treated the biological soil 

amendment of animal origin on your 

own farm in accordance with this 

proposed rule. Aspect (ii) of this 

requirement would provide you with 

reasonable assurances that your supplier 

is carrying out the applicable treatment 

process in an effective manner such that 

the biological soil amendment of animal 

origin that you purchase meets the 

applicable standards in proposed 

§§ 112.54 and 112.55. We tentatively 

conclude that it is appropriate to require 

this additional level of assurance from 

your suppliers in order to allow FDA to 

verify your compliance with these 

requirements. These requirements will 

also provide you with a comparable 

level of control over your supplier’s 

process of treating a biological soil 

amendment of animal origin as you 

would have if you were to apply the 

treatment process on-farm, where you 

would be able to monitor the process 

controls yourself. You would not be 

required to perform any treatment 

processes on a biological soil 

amendment of animal origin that you 

purchase and for which you have the 

appropriate documentation showing it 

has already been treated by a validated 

process in accordance with § 112.55. 

These records would also allow you to 

ensure that a treated biological soil 

amendment that you purchase from a 

third party meets the requirements of 

this proposed rule and to determine the 

relevant application restrictions you 

must apply to such a soil amendment. 

Proposed § 112.60(b)(3) would require 

documentation that process controls (for 

example, time, temperature and 

turnings) were achieved for any treated 

biological soil amendment of animal 

origin you produce for your own 

covered farms. This documentation is 

required to verify that the treatment or 

treatments you performed were properly 

carried out. For example, such records 

would inform you of any breakdown in 

the process or treatments, how they 

occurred or can be corrected, and create 

a history to help you predict and 

prevent any future breakdowns. Without 

such records, you would not be able to 

ensure, and we would not be able to 

verify, that the process or treatment you 

performed achieved the required 

parameters that are validated to meet 

the microbial standards of § 112.55 or 

that the alternatives 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 composting 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 

scientific data or information you rely 

on to support any alternative minimum 

application 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 processes 

presented in § 112.54(c)(1) and (c)(2) or 

application intervals in § 112.56(a)(1)(i) 

and (a)(4)(i), respectively. This 

documentation would be required so 

that, as necessary, we are able to verify 

that use of your alternative process 

achieves the required parameters of 

proposed subpart F and satisfies the 

requirements of proposed § 112.12. 

Finally, we seek comment on an issue 

that is not explicitly addressed in our 

proposed provisions. Biological soil 

amendments (including agricultural teas 

derived from biological materials) are 

nutrient rich and may support rapid and 

prolific growth of human pathogens, if 

pathogens are present. Seeds used for 

sprouting have repeatedly been 

demonstrated to have the potential to be 

contaminated with human pathogens 

and cause human illnesses. We note that 

the National Organic Standards Board 

Compost Tea Task Force recommended 

not allowing for the use of ‘‘compost 

tea’’ for the production of edible seed 

sprouts (Ref. 36). We are concerned that 

using a biological soil amendment 

(including agricultural teas derived from 

biological materials) could increase the 

likelihood of rapid and prolific growth 

of human pathogens, if present, during 

sprout growing. We request comment on 

whether sprouters currently use 

biological soil amendments (including 

agricultural teas made from biological 

materials, such as ‘‘compost teas’’) in 

the growing of sprouts. In addition, we 

request comment on the likelihood of 

contamination presented by such a 

practice and whether the practice 

should be prohibited. 

G. Subpart G—We Have Tentatively 

Reserved Subpart G of This Proposed 

Rule 

H. Subpart H—We Have Tentatively 

Reserved Subpart H of This Proposed 

Rule 

I. Subpart I—Standards Directed to 

Domesticated and Wild Animals 

As proposed, subpart I provides 

science-based minimum standards that 

are directed to domesticated and wild 

animals and are reasonably necessary to 

minimize the risk of serious adverse 

health consequences or death from the 

use of, or exposure to, covered produce, 

including those reasonably necessary to 

prevent the introduction of known or 

reasonably foreseeable hazards into 

covered produce, and to provide 

reasonable assurances that the produce 

is not adulterated under section 402 of 

the FD&C Act. 

1. Comments Related to Proposed 

Provisions 

We received several comments in 

response to the 2010 FR notice that 

addressed issues relevant to standards 

directed to domesticated and wild 

animals. Some comments expressed 

concern about requiring measures that 

prohibit the use of domesticated work 

animals on farms. Some comments 

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3586 Federal Register / Vol. 78, No. 11 / Wednesday, January 16, 2013 / Proposed Rules 

asserted that monitoring wildlife in a 

farm environment is untenable, whereas 

other comments recommended that we 

prepare a list of ‘‘animals of concern’’ to 

enable farmers to know where to target 

preventive controls for domesticated 

and wild animals. Some comments 

recommended that sustainable 

conservation practices should be 

adopted and recognized as enhancing 

food safety. Several comments noted 

that farmers are subject to State and 

Federal laws regarding wildlife (e.g., 

Endangered Species Act and Clean 

Water Act) and that there are programs 

that emphasize environmental 

stewardship (e.g., National Organic 

Program and programs of the Natural 

Resources Conservation Service). Others 

expressed concern about any 

requirements that would lead to 

destruction of habitat or clearing of farm 

borders. 

This proposed rule would not 

prohibit the use of on-farm 

domesticated working animals. Rather, 

this proposed rule would require you to 

take measures to prevent the 

introduction of known or reasonably 

foreseeable hazards into or onto covered 

produce, if you use working animals in 

a growing area where a crop has been 

planted and when, under the 

circumstances, there is a reasonable 

probability that animals will 

contaminate covered produce. We 

disagree with comments that asserted 

that monitoring for animal intrusion is 

untenable. Periodic monitoring for 

animal intrusion and deposition of their 

excreta is a necessary measure to 

prevent contamination of covered 

produce with biological food safety 

hazards when there is a reasonable 

probability that animals will 

contaminate covered produce. We 

consider that monitoring during the 

growing season and immediately prior 

to harvest is a practical and minimum 

necessary standard to sufficiently 

ensure that any potential hazards 

related to animal intrusion are 

identified for appropriate follow-up 

actions in these situations. Proposed 

§ 112.83 is intended to provide you with 

information about animal movements 

on your farm, allow you to recognize 

significant intrusion, and facilitate your 

taking appropriate measures following 

significant animal intrusion. 

While we recognize the value of 

establishing a list of ‘‘animals of 

concern,’’ we tentatively conclude that 

current scientific evidence on the extent 

to which specific animals present the 

greatest risk for pathogens is inadequate 

to develop such a list. Moreover, data on 

regional and seasonal variations in the 

prevalence of pathogens in different 

kinds of animals are scarce. We 

encourage the application of practices 

that can enhance food safety, including 

sustainable conservation practices. A set 

of examples of biodiversity and 

conservation practices that may enhance 

food safety is available from the 

Resource Conservation District of 

Monterey County, CA (Ref. 199). This 

proposed rule would not require the 

destruction of habitat or the clearing of 

farm borders. Instead, we propose to 

require you to monitor those areas that 

are used for a covered activity for 

evidence of animal intrusion when, 

under the circumstances, there is a 

reasonable probability that animals will 

contaminate covered produce. 

2. Proposed Requirements 

Proposed subpart I includes standards 

that would be directed to the potential 

for biological hazards from animal 

excreta to be deposited by your own 

domesticated animals (such as livestock, 

working animals, and pets), by 

domesticated animals from a nearby 

area (such as livestock from a nearby 

farm), or by wild animals (such as deer 

and wild swine) on covered produce or 

in an area where you conduct a covered 

activity on covered produce. Proposed 

subpart I would not be directed to the 

potential for biological hazards from 

manure that may be used as a soil 

amendment; such requirements directed 

to biological soil amendments of animal 

origin are discussed in section V.F of 

this document. 

Consistent with sections 419(a)(1)(A), 

419(a)(3)(E), and 419(a)(3)(D) of the Act, 

we consulted with USDA’s National 

Organic Program and Natural Resources 

Conservation Service, U.S. Fish and 

Wildlife Service, and the EPA (Ref. 115) 

to ensure that environmental and 

conservation standards and policies 

established by those agencies are 

appropriately considered in developing 

the requirements proposed in this 

subpart. Based on these consultations, 

we tentatively conclude that the 

provisions of proposed subpart I do not 

conflict with or duplicate the 

requirements of the National Organic 

Program. In addition, also based on 

these consultations, we tentatively 

conclude that the provisions of 

proposed subpart I are consistent with 

existing conservation and 

environmental practice standards and 

policies while providing for enforceable 

public health protection measures. 

Furthermore, the provisions in proposed 

subpart I are consistent with current 

recommendations in our GAPs Guide 

(Ref. 10), the AFDO Model Code (Ref. 

20), Commodity-specific industry 

guidances (Ref. 44. Ref. 46), and the 

LGMA (Ref. 31). We seek comment on 

the interactions of the proposed rule 

with the National Organic Program and 

opportunities to streamline compliance 

with both programs. 

We acknowledge the longstanding colocation of animals and plant food 

production in agriculture. However, as 

discussed in the QAR, both wild and 

domestic animals may be a source of 

human pathogens. In fact, domesticated 

animals, due to their close proximity 

and interaction with humans, are 

generally more likely to harbor zoonotic 

pathogens than are wild animals (Ref. 

200). Therefore we tentatively conclude 

that measures should be taken to 

minimize the likelihood of covered 

produce being contaminated by excreta 

from grazing and working animals. The 

likelihood of contaminating fresh 

produce with human pathogens from 

excreta from grazing and working 

animals is determined by numerous 

factors, including but not limited to the 

species of the animal, the number of 

animals per unit area of land, agroecological 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 establish 

that the requirements of proposed 

subpart I apply when a covered activity 

takes place in an outdoor area or a 

partially-enclosed building and when, 

under the circumstances, there is a 

reasonable probability that animals will 

contaminate covered produce. We have 

tentatively concluded that measures 

directed to domesticated and wild 

animals (such as cows, swine, and deer) 

are necessary when a covered activity 

takes place in an outdoor area or a 

partially-enclosed building if, under the 

circumstances, there is a reasonable 

probability that animals will 

contaminate covered produce, because 

it is reasonably likely that such animals 

will encroach on such areas and deposit 

excreta on covered produce or food 

contact surfaces. Some human 

pathogens of public health concern (e.g., 

E. coli O157:H7) that have been 

associated with produce foodborne 

outbreaks are zoonotic, meaning that 

they may originate from animals as well 

as humans. Therefore, animals, both 

wild and domestic, may be a source of 

human pathogens during the growing, 

harvesting, packing and holding of 

covered produce. We expect this 

provision to provide flexibility for 

farmers to consider the nature of 

covered produce and covered activities 

(including characteristics of covered 

produce) in light of the potential for 

contamination, and determine whether 

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the proposed requirements of subpart I 

would be applicable under the 

circumstances. For example, in the case 

of covered produce that grows 

completely underground, we expect that 

there would not be a reasonable 

probability of contamination of covered 

produce by domesticated or wild 

animals that may graze on or encroach 

into fields. The proposed requirements 

in §§ 112.82 and 112.83, therefore, 

would not apply to covered activities 

taking place in an outdoor area or a 

partially-enclosed building when such 

activities relate to covered produce that 

grows completely underground. We 

note, however, that we do not intend the 

phrase ‘‘under the circumstances’’ in 

these proposed requirements to suggest 

that farms alter their surrounding 

environment in order to reduce the 

chances of animal intrusion, such as by 

clearing farm borders around outdoor 

growing areas or drainages. This 

proposed rule is not intended to require 

such actions. We intend the phrase 

‘‘under the circumstances’’ to refer to 

the nature of the covered produce (such 

as its growth habit) and the nature of 

covered activities (such as the manner 

in which working animals are used in 

growing areas). We request comment on 

this issue. 

Proposed § 112.81(b) would provide 

that the provisions of proposed subpart 

I would not apply to fully enclosed 

buildings. We tentatively conclude that 

the measures proposed in this section 

directed to domesticated and wild 

animals (such as cows, dogs, swine, and 

deer) are not necessary when a covered 

activity takes place in a fully-enclosed 

building. Rather, we propose measures 

directed at domesticated and wild 

animals (such as horses, dogs, and 

rodents) in a fully-enclosed building in 

proposed § 112.127 (see section V.L. of 

this document). 

Proposed § 112.82 would establish 

requirements for measures that you 

must take, at a minimum, if you allow 

animals to graze or use them as working 

animals in fields where you grow 

covered produce and under the 

circumstances there is a reasonable 

probability that grazing or working 

animals will contaminate covered 

produce. Proposed § 112.82(a) would 

require you to implement an adequate 

waiting period between grazing and 

time of harvest for covered produce in 

any growing area that was grazed, to 

ensure the safety of the harvested crop. 

The potential likelihood of animals to 

act as vectors of human pathogens is 

determined by several factors, including 

but not limited to the type of 

commodity (as discussed above), and 

the species of the animal and its 

association with human or domesticated 

animal activity or waste (Ref. 199). A 

suitable time period based on these and 

other relevant factors must be 

established for the purpose of reducing, 

via die-off, pathogen levels in the 

excreta that may be transferred to 

covered produce. We would not expect 

it to be necessary for such time periods 

to exceed 9 months, which is the 

application interval we propose for use 

of raw manure as a soil amendment in 

proposed § 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 measures to 

prevent the introduction of known or 

reasonably foreseeable hazards into or 

onto covered produce. For example, if 

you use draft horses as working animals 

in your covered produce fields, you 

could establish and use horse paths 

which are segregated from covered 

produce plantings, and minimize entry 

of the horses into covered produce 

plantings, thus minimizing the 

opportunity for horse excreta to contact 

covered produce or food contact 

surfaces. 

Proposed § 112.83 would establish 

requirements for measures related to 

animal intrusion in those areas that are 

used for covered activities for covered 

produce when under the circumstances 

there is a reasonable probability that 

animal intrusion will contaminate 

covered produce. We are proposing to 

require that you monitor these areas as 

needed throughout the growing season, 

based on the covered produce being 

grown and your observations and 

experiences (proposed § 112.83(a)(1)(i) 

and (ii)), and immediately prior to 

harvest (proposed § 112.83(a)(2)). In 

proposed § 112.83(b) we would also 

require that, if animal intrusion occurs, 

as evidenced by observation of 

significant quantities of animals, animal 

excreta or crop destruction via grazing, 

you must evaluate whether the covered 

produce can be harvested in accordance 

with the requirements of proposed 

§ 112.112. 

We acknowledge that when covered 

produce is grown in an outdoor 

environment, wild animals are likely to 

have access to production fields. The 

presence of animals in a production 

field of covered produce, in and of 

itself, is not a significant food safety 

risk. However, wild animals are known 

zoonotic disease reservoirs for human 

pathogens, and therefore their excreta 

may contaminate growing covered 

produce crops (Ref. 169. Ref. 203). 

Monitoring immediately prior to harvest 

will enable you to identify instances 

when covered produce cannot be safely 

harvested, such as when it is not 

possible to effectively avoid the harvest 

of covered produce that was directly 

exposed to animal excreta or that may 

be cross-contaminated during harvest 

(e.g., contamination of covered produce 

by contact with a food-contact surface 

that contacted animal excreta), as 

provided for in proposed § 112.112. 

Monitoring throughout the growing 

season may assist you in developing an 

understanding of when and the degree 

to which animal intrusion occurs 

throughout the production season from 

planting to harvest. This proposed 

provision should not be construed to 

require the ‘‘taking’’ of an endangered 

species, as the term is defined in the 

Endangered Species Act (16 U.S.C. 

1532(19)) (i.e., to harass, harm, pursue, 

hunt, shoot, wound, kill, trap, capture, 

or collect, or to attempt to engage in any 

such conduct), or to require farms to 

take measures to exclude animals from 

outdoor growing areas or destroy animal 

habitat or otherwise clear farm borders 

around outdoor growing areas or 

drainages. 

J. Subpart J—We Have Tentatively 

Reserved Subpart J of This Proposed 

Rule 

K. Subpart K—Standards Directed to 

Growing, Harvesting, Packing, and 

Holding Activities 

As proposed, subpart K discusses 

science-based minimum standards 

directed to growing, harvesting, 

packing, and holding activities that are 

reasonably necessary to minimize the 

risk of serious adverse health 

consequences or death from the use of, 

or exposure to, covered produce, 

including those reasonably necessary to 

prevent the introduction of known or 

reasonably foreseeable hazards into 

covered produce, and to provide 

reasonable assurances that the produce 

is not adulterated under section 402 of 

the FD&C Act. 

1. Comments Relevant to the Proposed 

Provisions 

We received some comments in 

response to the 2010 FR notice that 

addressed the adequacy and cleanliness 

of food-packing material and requested 

that reusable containers be allowed in 

packing produce commodities. 

It is important to ensure that foodpacking material that is used in covered 

activities is adequate for its intended 

use, including that it is clean. In 

proposed § 112.116 below, we address 

the adequacy and cleanliness of foodpacking material. Specifically, proposed 

§ 112.116(b) would require that if you 

reuse food-packing material, you take 

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measures to ensure that food-contact 

surfaces are clean, such as by cleaning 

and sanitizing, when necessary, foodpacking containers or using a clean 

liner. 

2. Proposed Requirements 

Proposed § 112.111 would establish 

that if you grow, harvest, pack or hold 

produce that is not covered in this part 

(i.e., excluded produce in accordance 

with § 112.2) and also conduct such 

activities on covered produce, and the 

excluded produce is not grown, 

harvested, packed or held in accordance 

with this part, you must take measures 

during these covered activities, as 

applicable, to: (a) Keep covered produce 

separate from excluded produce 

(proposed § 112.111(a)); and (b) 

Adequately clean and sanitize, as 

necessary, any food-contact surfaces 

that contact excluded produce before 

using such food-contact surfaces for 

covered activities on covered produce 

(proposed § 112.111(b)). As discussed in 

the QAR, raw produce may have a 

variety of microorganisms in and on it, 

including, occasionally, human 

pathogens. The types of 

microorganisms, including human 

pathogens, detected on raw produce are 

diverse and may often be found in high 

numbers (Ref. 204. Ref. 205. Ref. 206). 

In addition, some human pathogens that 

are commonly isolated from the growing 

environment (e.g., L. monocytogenes) 

are reported to adapt and survive in the 

food production environment (e.g., food 

contact surfaces, floors, walls, drains, 

sinks, standing water, and seals) and, 

thus, pose a potential source of 

contamination (Ref. 207). The proposed 

standards included in this part are 

designed to reduce the likelihood that 

human pathogens are present in or on 

covered produce. For this reason, 

excluded produce that is not grown, 

harvested, packed and stored in 

accordance with the standards proposed 

in this part is likely to present a greater 

likelihood of contamination with 

human pathogens than would covered 

produce that is grown, harvested, 

packed, and held in accordance with 

this part. We tentatively conclude that 

for operations handling both covered 

and excluded produce, crosscontamination is reasonably likely in 

the absence of measures directed toward 

its prevention. Such measures include 

separation of the two types of produce 

to avoid physical contact and any 

transfer of pathogens from one to the 

other; and cleaning and sanitizing, as 

necessary, food contact surfaces used on 

such excluded produce before those 

surfaces come in contact with covered 

produce so that any pathogens picked 

up by the food-contact surface from 

excluded produce are not transferred to 

covered produce. 

Proposed § 112.112 would require you 

to take all measures reasonably 

necessary to identify, and not harvest, 

covered produce that is reasonably 

likely to be contaminated with a known 

or reasonably foreseeable hazard, 

including steps to identify and not 

harvest covered produce that is visibly 

contaminated with animal excreta. For 

example, you would comply with this 

provision by not harvesting a head of 

lettuce if you see evidence of bird 

excreta on the head of lettuce. As 

discussed in the QAR, it is well 

established that animal excreta is a 

source of pathogens. Transmission of 

pathogens from animal excreta to 

covered produce and, subsequently, to 

humans through consumption is 

reasonably likely in cases where the 

presence of animal excreta can be 

visually confirmed. Therefore, if the 

presence of animal excreta in a field of 

covered produce precludes your ability 

to safely harvest the covered produce, 

either because a significant portion of 

the covered produce has animal excreta 

on it or because the animal excreta that 

is present would be likely to 

contaminate food contact surfaces of 

harvest equipment, you must not 

harvest the relevant portions of that 

field. 

Proposed § 112.113 would require 

that you handle harvested covered 

produce during covered activities in a 

manner that protects against 

contamination with known or 

reasonably foreseeable hazards, for 

example, by avoiding contact of cut 

surfaces of harvested produce with soil. 

As discussed in the QAR, research 

demonstrates that soil microorganisms, 

including human pathogens, may 

effectively colonize produce when the 

produce has lost its protective covering 

(e.g. cuticle) in the course of harvest 

activities (e.g., cutting or trimming) or 

when damaged during such operations 

(Ref. 208. Ref. 209). Once established, 

the high moisture content of produce 

provides a suitable environment for 

survival and growth of such pathogens. 

Pathogens, if present, may be transferred 

to cut surfaces of harvested produce 

from soil and, therefore, preventing 

unnecessary contact between such cut 

surfaces and soil will reduce the 

likelihood of such transfer. For example, 

you could take steps to temporarily 

place cut lettuce heads on clean 

cardboard or other clean surface during 

field packing, rather than placing them 

directly on the soil. 

We considered washing as a 

requirement to reduce the likelihood of 

contamination. Washing is an attractive 

option because it effectively removes 

excess dirt, debris, and other organic 

matter and its use incurs a relatively 

low cost allowing it to be employed 

across a variety of equipment (water 

flumes, hydrocoolers, dips, scrubbers, 

sorters, etc.) or steps in combination, or 

in sequence before packaging. Despite 

these advantages, a number of studies 

have concluded that wash water, with 

or without an active antimicrobial agent, 

does not completely disinfect produce 

that may contain microorganisms of 

public health significance (Ref. 206. Ref. 

210. Ref. 209). Wash water containing 

an antimicrobial such as chlorine is 

reported to reduce microbial 

populations by two or three log units 

(100 to 1000 fold), but does not 

eliminate microbes (Ref. 211. Ref. 210). 

Bacteria may find harborage and 

protection on plants through 

hydrophobic areas, stomata, lenticels, 

punctures, and bruises and where it is 

not readily washed off (Ref. 212. Ref. 

213). Of special significance to bacterial 

survival on plants are circumstances 

that lead to bacterial cells being drawn 

in or internalized inside the edible 

portion of the plant where they may 

escape the action of water altogether. 

This phenomenon, termed 

internalization, may occur as a 

consequence of temperature 

differentials created when warm 

produce (from field heat or daytime 

high temperatures) is submerged in 

cooler water. Under these conditions, 

infiltration of water occurs because 

intercellular air spaces within fruits and 

vegetables contract, thereby creating a 

partial pressure differential that draws 

the water into the internal 

compartments of the plant. If the 

cooling water contains human 

pathogens the fresh produce item will 

now be internally contaminated. This 

phenomenon has been seen with 

Salmonella and E. coli O157:H7 in 

tomatoes, oranges, or mangoes (Ref. 138. 

Ref. 139. Ref. 214). As part of a postoutbreak study, Penteado et al. 2004 

reported evidence that Salmonella spp. 

may have internalized in fresh mangoes 

during a postharvest cooling step 

involving a water bath (Ref. 38). We 

seek comment on whether we should 

consider washing, alone or in 

combination with other measures, as a 

requirement to reduce the likelihood of 

contamination. 

Proposed § 112.114 would prohibit 

you from distributing covered produce 

that drops to the ground before harvest 

(dropped covered produce) unless it is 

exempt under § 112.2(b) (i.e. if it 

receives commercial processing to 

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adequately reduce the presence of 

microorganisms of public health 

significance). Dropped covered produce 

does not include root crops (such as 

carrots) that grow underground or crops 

(such as cantaloupe) that grow on the 

ground. However, produce that grows 

off the ground, such as tomatoes and 

apples, and that drop to the ground 

before harvest would be considered 

dropped covered produce. Evidence 

from studies of tree fruit (e.g., apples 

and pears) indicates that dropped and 

damaged fruit contain coliform bacteria 

in significantly higher numbers than 

intact tree fruit (Ref. 215). Risk 

assessment models for apple 

contamination (Ref. 216) show that 

dropped apples are more likely to be 

contaminated with bacteria than treepicked apples, and dropped fruit used 

in the production of apple products 

(e.g., apple cider) are likely to increase 

rates of product contamination (Ref. 

216). While data available to us is 

primarily derived from studies 

investigating apples, we tentatively 

conclude that all dropped covered 

produce is likely to present a potential 

likelihood for contamination, although 

to varying degrees. Studies have 

indicated that when produce drops to 

the ground, the produce can become 

structurally damaged, which is 

considered to be a factor for 

proliferation of human pathogens on 

such produce (Ref. 217. Ref. 218. Ref. 

219). Excluding dropped fruit from 

harvest is also recommended in some 

existing guidance documents (Ref. 220. 

Ref. 221. Ref. 44). However, some 

produce is dropped to the ground as a 

part of the harvesting practice (e.g., 

some tree nuts). We expect that such 

harvesting practices were developed 

because the fall does not damage the 

edible crop, because the crop is 

protected with a durable shell. 

Accordingly, we have defined ‘‘dropped 

covered produce’’ to exclude produce 

that is intentionally dropped as part of 

harvesting. Further, we do not propose 

to prohibit the use of dropped covered 

produce in a commercial process (e.g., 

canning) that is designed to adequately 

reduce the presence of microorganisms 

of public health significance. Therefore, 

dropped covered produce that is exempt 

under proposed § 112.2(b) may be 

distributed for such commercial 

processing as described in proposed 

§ 112.2 (see section V.A. of this 

document). 

We seek comment on this provision 

and whether specific commodities 

should be exempted from this provision 

based on the harvesting practices 

associated with the commodity and/or 

the nature of the commodity itself. If 

specific commodities should be 

exempted from this provision, please 

explain the practices, processes, and 

conditions associated with that 

commodity that would justify such 

exemption. We expect that this 

proposed provision would prevent the 

marketing for fresh use of produce that 

may have been bruised as a result of the 

fall. As noted above, damaged or 

bruised fruit provide an opportunity for 

pathogen intrusion into the edible 

portion and may liberate nutrients for 

pathogen growth. We note that produce 

that is intentionally dropped to the 

ground as part of the harvesting method 

would not be considered ‘‘dropped 

covered produce’’ as defined in 

proposed § 112.114 (i.e., produce that 

drops to the ground before harvest). We 

seek comment on whether proposed 

§ 112.114 adequately takes into account 

produce that is intentionally dropped 

during harvesting and whether such 

harvesting practices do not cause 

damage to the produce. Proposed 

§ 112.115 would establish measures that 

you must take when packaging covered 

produce. Specifically, proposed 

§ 112.115 would require that you 

package covered produce in a manner 

that prevents the formation of 

Clostridium botulinum toxin, if such 

toxin is a known or reasonably 

foreseeable hazard (such as for 

mushrooms). The potential for toxin 

production by C. botulinum in 

mushrooms packaged under reduced 

oxygen conditions is well-known (Ref. 

222). Mushrooms grow close to the 

ground, which is a source of C. 

botulinum spores. Mushrooms remain 

metabolically active after harvest, which 

may quickly reduce the amount of 

oxygen, particularly when mushrooms 

are packaged under conditions that limit 

the transfer of oxygen across the layer of 

packaging (Ref. 223). In such reduced 

oxygen or anoxic conditions, C. 

botulinum spores can germinate 

resulting in the formation of botulinum 

toxin, which can occur before any overt 

signs of mushroom spoilage (Ref. 222). 

Modified or reduced-oxygen packaging 

of other produce may present a similar 

risk for botulinum toxin formation (Ref. 

224). Perforated packaging film allows 

free air access to mushrooms and is 

recommended as a means to reduce the 

potential for toxin formation in 

mushrooms (Ref. 225). Other means of 

preventing toxin formation in modified 

or reduced oxygen packaging may 

include use of time-temperature 

integrators on individual packages of 

produce to signal when a cumulative 

time-temperature combination has been 

reached that presents a risk for C. 

botulinum toxin formation or use of 

antimicrobial compounds (Ref. 224). We 

request comment on the need for this 

proposed provision and on the types or 

conditions of modified or reduced 

oxygen packaging methods that may or 

may not increase the risk of formation 

of botulinum toxin. 

Proposed § 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 foodpacking material must be adequate for 

its intended use. For example, foodpacking material that would be adequate 

for its intended use include plastic bins 

for holding fresh-picked fruit, waximpregnated corrugated cardboard for 

broccoli to be hydrocooled or top-iced 

after packing, plastic clamshells used 

for packaging strawberries for retail sale, 

and single-use cardboard containers for 

packing tomatoes. Wooden bins or 

boxes, and canvas bags that may be used 

during harvest also would need to meet 

this requirement, and could be used if 

they are adequately clean and sanitary 

for their intended use. To implement 

this provision, you would have to use 

food-packing materials that are: (1) 

Cleanable or designed for single use and 

(2) unlikely to support growth or 

transfer of bacteria. In addition, 

proposed § 112.116(b) would require 

that if you reuse food-packing material, 

you take measures to ensure that foodcontact surfaces are clean, such as by 

cleaning and sanitizing, when 

necessary, food-packing containers or 

using a clean liner. Evidence from 

scientific literature indicates that the 

number of microorganisms detected on 

the surface of fruits is directly correlated 

to the amount of contact time between 

the fruit commodity and its packing 

material (Ref. 226. Ref. 227). Although 

some food-packing material is 

sufficiently sturdy to be used multiple 

times, it may serve as a source of 

contamination in the absence of regular 

cleaning and sanitizing between each 

such use. Further, certain food-packing 

material may have a serviceable shelf 

life beyond which it may not possible to 

effectively clean and sanitize the 

material. It is reasonably likely that such 

packing material, if it continues to be 

used, may serve as harborage sites for 

pathogens, if they become established 

on its surface. 

L. Subpart L—Standards Directed to 

Equipment, Tools, Buildings, and 

Sanitation 

Proposed subpart L establishes 

science-based minimum standards that 

are reasonably necessary to prevent 

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equipment, tools, buildings, and 

inadequate sanitation from introducing 

known or reasonably foreseeable 

hazards into or onto covered produce or 

food-contact surfaces, and to provide 

reasonable assurances that the covered 

produce is not adulterated under section 

402 of the FD&C Act. 

A few comments recommended that 

equipment used to hold or convey water 

should be inspected to ensure that it is 

clean. 

We agree that equipment used to hold 

or convey water should be maintained 

in a manner necessary to protect against 

contamination. In 112.42 (b), we would 

require that you must adequately 

maintain all agricultural water sources 

that are under your control (such as 

wells) by regularly inspecting each 

source and keeping the source free of 

debris, trash, domesticated animals, and 

other possible sources of contamination 

of covered produce to the extent 

practicable and appropriate under the 

circumstances. In 112.42 (c), we would 

require that you must adequately 

maintain all agricultural water 

distribution systems as necessary and 

appropriate to prevent the water 

distribution system from being a source 

of contamination to covered produce, 

food-contact surfaces, areas used for a 

covered activity, or water sources, 

including by regularly inspecting and 

adequately storing all equipment used 

in the system. 

1. Comments Relevant to Proposed 

Provisions 

We received some comments in 

response to the 2010 FR notice that 

expressed that the use of animals on a 

farm or their presence near farming 

operations should not be prohibited. 

We address issues related to animals 

in and around farming operations in 

subpart I (see section V.I. of this 

document) of this rule. However, in this 

subpart, we address the presence of 

animals in fully-enclosed buildings. 

Specifically, proposed § 112.127 would 

require that you take reasonable 

precautions to prevent domesticated 

animals, including guard and guide 

dogs, in and around a fully-enclosed 

building from contaminating covered 

produce, food-contact surfaces, and food 

packing materials with known or 

reasonably foreseeable hazards. 

2. Proposed Requirements 

a. Equipment, Tools, and Buildings That 

Are Subject to the Requirements of This 

Subpart 

Any equipment and tools used during 

covered activities that are intended to, 

or likely to, contact covered produce 

would be subject to proposed subpart L. 

In addition, instruments or controls 

used to measure, regulate, or record 

conditions to control or prevent the 

growth of undesirable microorganisms 

or other contamination would be subject 

to proposed subpart L. In proposed 

§ 112.121, we provide examples of such 

equipment and tools, i.e., knives, 

implements, mechanical harvesters, 

waxing machinery, cooling equipment 

(including hydrocoolers), grading belts, 

sizing equipment, palletizing 

equipment, and equipment used to store 

or convey harvested covered produce 

(such as containers, bins, food-packing 

material, dump tanks, flumes, and 

vehicles or other equipment used for 

transport). 

Proposed § 112.122 would identify 

the types of buildings that are subject to 

the requirements of proposed subpart L. 

Such buildings would include any fullyor partially-enclosed buildings used for 

covered activities, including minimal 

structures that have a roof but do not 

have any walls (proposed § 112.122(a)). 

Fully-enclosed buildings are typically 

used to grow covered produce such as 

sprouts and mushrooms and may be 

used to grow a variety of covered 

produce indoors to create or extend the 

growing season in a particular 

geographic area. Partially-enclosed 

buildings can be used to grow covered 

produce such as tomatoes, and are often 

used to pack covered produce. 

Buildings that are subject to the 

requirements of the rule would also 

include storage sheds, buildings, or 

other structures used to store foodcontact surfaces (such as harvest 

containers and food-packing materials) 

(proposed § 112.122(b)). We are 

proposing this requirement because 

contaminated food-contact surfaces can 

contaminate covered produce (Ref. 182) 

(Ref. 228) and, thus, present a potential 

hazard. 

b. General Requirements Applicable to 

Equipment and Tools 

As proposed, § 112.123 establishes 

general requirements applicable 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 

workmanship to enable them to be 

adequately cleaned and properly 

maintained. For example, some lettuce 

coring knives currently used in the 

industry are designed in a way that 

gives them the propensity to transfer 

microbial contaminants from soil to the 

lettuce (Ref. 229). Using a tool that is 

designed to minimize the potential for 

pathogen transfer from soil to the 

produce and/or that allows for 

mechanical polishing to facilitate 

cleaning and sanitizing the tool would 

enhance food safety (Ref. 230). 

Proposed § 112.123(b)(1) would 

establish that equipment and tools you 

use must be installed and maintained in 

a manner that facilitates cleaning of the 

equipment and of all adjacent spaces. 

For example, equipment that is 

permanently installed in an on-farm 

packing operation would need to be 

installed in such a manner that both 

maintenance and cleaning crews are 

able to easily access any food contact 

surfaces, protective covering or barriers, 

and any movable parts or other potential 

sources of contamination. A conveyor 

belt system that is part of a grading line 

would be considered properly installed 

if there is easy access to the belt (a foodcontact 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 equipment and tools you 

use must be stored and maintained to 

protect covered produce from being 

contaminated with known or reasonably 

foreseeable hazards and to prevent the 

equipment and tools from attracting or 

harboring pests. As discussed in the 

QAR, if farm equipment or tools are 

stored outside or in a partially-enclosed 

building, they may attract or harbor 

pests, which can carry human 

pathogens (Ref. 231). Appropriate 

practices for storing and maintaining 

equipment and tools can reduce the 

potential for these problems. For 

example, you would comply with this 

provision by storing equipment and 

tools indoors when practical, and when 

not practical, minimizing surrounding 

debris and checking periodically for 

pests. 

Proposed § 112.123(c) would establish 

that seams on food-contact surfaces of 

equipment and tools that you use must 

be either smoothly bonded, or 

maintained to minimize accumulation 

of dirt, filth, food particles, and organic 

material and thus minimize the 

opportunity for harborage or growth of 

microorganisms. This provision is 

consistent with current § 110.40(a) and 

(b) and § 111.27(a). 

Proposed § 112.123(d)(1) would 

require you to inspect, maintain, and 

clean and sanitize (when necessary and 

appropriate) all food-contact surfaces of 

equipment and tools used in covered 

activities as frequently as reasonably 

necessary to protect against 

contamination of covered produce. This 

provision is intended to prevent transfer 

of contaminants on food-contact 

surfaces of equipment or tools (e.g., 

harvest knives, grading belts, or harvest 

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bins) to covered produce. As discussed 

in the QAR, for example, it has been 

documented that E. coli O157:H7 can be 

transferred to Iceberg lettuce from 

contaminated coring devices used in a 

simulated field coring (Ref. 229). Even 

food contact surfaces made of stainless 

steel can transfer pathogens to covered 

produce, if not properly cleaned and 

sanitized. For example, transfer of 

pathogens from stainless steel tools to 

lettuce has been demonstrated to occur 

to various extents, depending on the 

amount of water on the leaf surface (Ref. 

232). 

Proposed § 112.123(d)(2) would 

require you to maintain and clean all 

non-food-contact surfaces of equipment 

and tools subject to subpart L used in 

covered activities during harvesting, 

packing, and holding as frequently as 

reasonably necessary to protect against 

contamination of covered produce. The 

potential for an equipment or tool to 

come into contact with covered produce 

varies with the type and intended use of 

the equipment or tool. Non-food-contact 

surfaces of tools and equipment used in 

contact with covered produce can be 

sources of contamination. Therefore, it 

is important to maintain such surfaces 

of covered equipment and tools in a 

clean and sanitary condition. However, 

such surfaces may not require cleaning 

as frequently as those that come into 

direct contact with produce, and may 

not require sanitizing. An example of 

such a surface is the handle of a tool 

used when working directly with 

covered produce, although depending 

on the use, such equipment or tool may 

be or consist of a food-contact surface. 

For example, a truck used to harvest 

produce may not need to be thoroughly 

cleaned or sanitized; however, the 

flatbed of the same truck if used to haul 

un-packed/loose produce would be 

considered a food-contact surface. 

Proposed § 112.123(e) would establish 

that, if you use equipment such as 

pallets, forklifts, tractors, and vehicles 

such that they are intended to, or likely 

to, contact covered produce, you do so 

in a manner that minimizes the 

potential for contamination of covered 

produce or food-contact surfaces with 

known or reasonably foreseeable 

hazards. For example, you may consider 

the appropriate route for any equipment 

to move in, through, and out of 

production fields, and when there may 

be a need to visually inspect and clean 

such equipment to prevent 

contamination or cross-contamination of 

covered produce. The potential for 

transfer of contaminants from tractors to 

covered produce, for example, if the 

tractors drive through or otherwise 

come in contact with manure is also 

highlighted in our GAPs Guide (Ref. 10). 

We seek comment on the 

appropriateness of the proposed 

cleaning provisions related to 

equipment and tools. 

c. General Requirements Applicable to 

Instruments and Controls 

Proposed § 112.124 would establish 

that instruments or controls you use to 

measure, regulate, or record 

temperatures, hydrogen-ion 

concentration (pH), sanitizer efficacy or 

other conditions, in order to control or 

prevent the growth of pathogens or 

other contamination, must be: (a) 

Accurate and precise as necessary and 

appropriate in keeping with their 

purpose; (b) adequately maintained; and 

(c) adequate in number for their 

designated uses. Proposed § 112.124 is 

consistent with current § 111.27(a)(6), 

and similar to requirements in current 

§ 110.40(f). Accuracy addresses whether 

the recorded measurements are equal to 

the true value of that which is being 

measured, while precision addresses 

whether individual measurements are 

close to each other when made under 

the same conditions. Both accuracy and 

precision are necessary to ensure the 

validity and reliability of measurements. 

The appropriate degree of accuracy and 

precision, however, would need to be 

determined based on the nature of the 

instrument and its specific use for the 

covered activity. Instruments must also 

be adequately maintained to ensure that 

they are functioning properly for their 

intended use. For example, an in-line 

water oxidation-reduction potential 

meter that is used to determine the 

approximate sanitizer concentration in a 

water flume system must be 

appropriately maintained to ensure that 

there is no debris build-up that would 

interfere with its proper operation. In 

addition, you must have an adequate 

number of instruments as needed for the 

designated use. For example, if you are 

composting a small pile of manure and 

monitoring the temperature, one 

thermometer may be sufficient. 

However, if you are composting large 

windrows in excess of several hundred 

yards in length, and using an automated 

system to monitor the internal 

temperature of the pile, you would need 

multiple thermocouples placed 

throughout the pile to get a good reading 

of the overall temperature. 

d. Transport of Covered Produce 

Proposed § 112.125 would establish 

that equipment subject to subpart L that 

you use to transport covered produce 

during covered activities must be: (a) 

Adequately clean before use in 

transporting covered produce; and (b) 

adequate for use in transporting covered 

produce. Transport equipment that is 

intended to, or likely to, contact covered 

produce that is not clean, or that is not 

adequate for the covered produce it is 

being used to transport, can be a source 

of cross-contamination of covered 

produce. Equipment used to transport 

covered produce would not be 

adequately clean if, for example, there is 

dirt, filth, organic material, particles of 

food, remains of previous shipping 

loads, or any other extraneous materials 

or contaminants on surfaces that are 

likely to come into contact with the 

produce. Equipment used to transport 

covered produce would not be adequate 

if, for example, the same equipment is 

used to haul live animals or garbage that 

is not completely contained, and the 

equipment is either not designed in a 

manner that allows cleaning and 

sanitizing or it is not cleaned or 

sanitized, before it is used to transport 

covered produce. Proposed § 112.125 is 

consistent with recommendations in 

FDA’s GAPs Guide (Ref. 10), the AFDO 

Model Code (Ref. 20), commodityspecific guidances (Ref. 85. Ref. 94. Ref. 

27), and international guidelines (Ref. 

96. Ref. 96). 

e. Design and Construction 

Requirements Applicable to Buildings 

Proposed § 112.126 would establish 

requirements 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 facilitate 

maintenance and sanitary operations for 

covered activities to reduce the 

potential for contamination of covered 

produce or food-contact surfaces with 

known or foreseeable hazards. For 

buildings to be suitable in size, it should 

have enough room for covered activities 

to be conducted without cross-contact 

between covered produce or foodcontact surfaces and building materials, 

non-food-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 covered 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 contamination of covered 

produce, food contact surfaces, or 

packing material with known or 

reasonably foreseeable hazards. The 

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potential for contamination must be 

reduced by effective design, including 

the separation of operations in which 

contamination is likely to occur, by one 

or more of the following means: 

Location, time, partition, enclosed 

systems, or other effective means. This 

provision provides flexibility in the 

precautions you take for your buildings 

and proposes separation of operations, 

such as by having sufficient space so 

that incompatible operations can be 

kept at a reasonable distance from each 

other, for example, so that spray coming 

off equipment being washed does not 

contact covered produce being packed. 

The proposed provisions in § 112.126(a) 

are similar to requirements in current 

§ 110.20(b)(2) and § 111.20. 

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 covered produce, foodcontact surfaces, or packing materials. 

Buildings where covered activities 

occur must be suitably constructed to 

allow adequate cleaning and sanitizing 

in order to minimize the presence or 

persistence of hazards and the potential 

for damage or contamination of covered 

produce. Buildings should be kept in 

good repair so as to prevent drip or 

condensate from pipes or ceilings to 

drop onto covered produce or foodcontact surfaces, and holes in walls of 

enclosed buildings from permitting 

pests access to covered produce or areas 

of covered activities. 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 requirements that you provide 

adequate drainage in all areas where 

normal operations release or discharge 

water or other liquid waste on the 

ground or floor of the building. Standing 

water can attract pests and support the 

growth of pathogens, such as L. 

monocytogenes, presenting potential for 

contamination of covered produce. The 

proposed provision in § 112.126(b) is 

similar to requirements in current 

§ 110.37(b)(4) and § 111.15(f)(4). 

f. Domesticated Animals in and Around 

Fully-Enclosed Buildings 

Proposed § 112.127(a) would require 

you to take reasonable precautions to 

prevent contamination of covered 

produce, food-contact surfaces, and 

food-packing materials in fully-enclosed 

buildings with known or reasonably 

foreseeable hazards from domesticated 

animals by: (1) Excluding domesticated 

animals from fully-enclosed buildings 

where covered produce, food-contact 

surfaces, or food-packing material is 

exposed; or (2) separating domesticated 

animals in a fully-enclosed building 

from an area where a covered activity is 

conducted on covered produce by 

location, time, or partition. As discussed 

in the QAR, domesticated animals can 

carry pathogens, potentially resulting in 

contamination of covered produce or 

food contact surfaces. However, 

consistent with current § 110.35(c), we 

propose to permit guard or guide dogs 

in some areas of a fully-enclosed 

building if the presence of the dogs is 

unlikely to result in contamination of 

produce, food-contact surfaces, or foodpacking materials (proposed 

§ 112.127(b)). You would need to take 

reasonable precautions to prevent 

contamination of covered produce, 

food-contact surfaces, and food-packing 

material with hazards from such dogs. 

We believe that animals such as guard 

or guide dogs, when kept under control 

and where the activities of the animal 

can be contained, are unlikely to result 

in contamination of produce, foodcontact surfaces, or food-packing 

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 

contact surfaces or food-packing 

materials. Therefore, in proposed 

§ 112.128(a), we propose to require you 

to take measures reasonably necessary 

to protect covered produce, food-contact 

surfaces, and food-packing materials 

from contamination by pests in 

buildings, including routine monitoring 

for pests as necessary and appropriate. 

Furthermore, we propose to require you 

to take measures to exclude pests from 

fully-enclosed buildings (proposed 

§ 112.128(b)) and to prevent pests from 

becoming established in partiallyenclosed buildings (such as by use of 

screens or by monitoring for the 

presence of pests and removing them, 

when present) (proposed § 112.128(c)). 

We recognize that it might be 

impossible to exclude pests, such as 

birds, from entering buildings that are 

not fully-enclosed. To comply with 

proposed § 112.128(c), you would need 

to take those steps reasonably necessary 

to prevent birds or other animals from 

building nests in partially-enclosed 

buildings and, if possible, to find and 

remove any nests that become 

established. Any measures or steps 

taken under these provisions would 

need to comply with applicable wildlife 

conservation regulations. 

h. Toilet and Hand-Washing Facilities 

Human feces may contain pathogens 

in relatively high concentrations (Ref. 

233). The most basic measure to prevent 

the potential transfer of pathogens from 

human feces into or onto covered 

produce and food-contact surfaces is to 

provide toilet facilities that collect and 

contain human feces. Proposed 

§ 112.129 would establish requirements 

related to toilet facilities, including that 

you must provide personnel with 

adequate, readily accessible toilet 

facilities, including facilities readily 

accessible to growing areas during 

harvesting activities (proposed 

§ 112.129(a)). In proposed § 112.129(b), 

we propose to establish that toilet 

facilities must be designed, located, and 

maintained to: (1) Prevent 

contamination of covered produce, 

food-contact surfaces, areas used for a 

covered activity, water sources, and 

water distribution systems with human 

waste (proposed § 112.129(b)(1)); (2) be 

directly accessible for servicing, be 

serviced and kept clean on a schedule 

sufficient to ensure suitability of use, 

and be kept supplied with toilet paper 

(proposed § 112.129(b)(2)); and (3) 

provide for the sanitary disposal of 

waste and toilet paper (proposed 

§ 112.129(b)(3)). These provisions are 

intended to contribute to an overall 

sanitary measure to help protect covered 

produce and areas where covered 

activities are conducted from 

contamination with pathogens. A 

portable toilet facility that leaks or a 

fixed toilet facility that lacks proper 

drainage or backflow devices would not 

be considered properly designed or 

maintained. As discussed in the QAR, 

runoff from such a toilet facility has the 

potential to directly contaminate 

covered produce, while contamination 

of soil and irrigation water from such 

runoff can have longer-lasting impact. 

To minimize the potential for 

contamination during events such as 

flooding or high winds, toilet facilities 

should be located away from water 

sources and water distribution systems, 

and at a reasonable distance from 

growing and packing areas. Sewage 

transport or other servicing trucks 

should have clear access to toilet 

facilities to ensure proper collection and 

disposal of wastes. In addition, workers 

are more likely to use toilet facilities 

that are clean, well-stocked, and in good 

condition (Ref. 234). We recognize that 

the growing area of a farm may spread 

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Federal Register / Vol. 78, No. 11 / Wednesday, January 16, 2013 / Proposed Rules 3593 

across several acres of land, and workers 

or visitors may be in growing areas for 

an extended period of time primarily 

during harvest activities. At times other 

than during harvest, we would consider 

toilet facilities to be readily accessible 

if, for example, the facility is available 

to workers at a farm building before and 

after they work in a growing area, or at 

a nearby public facility that is readily 

accessible to your workers. However, 

during harvest activities we consider it 

likely that workers and visitors will 

spend a significant amount of time in 

growing areas. We point out that the 

field sanitation requirements prescribed 

by the Occupational Safety and Health 

Administration (OSHA) under the 

Occupational Safety and Health Act, 

specifically 29 CFR 1928.110, describes 

the appropriate number of toilets to the 

number of workers, proper 

handwashing facilities, maximum 

worker-to-restroom distance, and 

frequency of cleaning facilities. 

Agricultural establishments subject to 

the requirements of 29 CFR 

1928.110(c)(2), must provide one toilet 

facility for each 20 employees or 

fraction thereof (except that toilet 

facilities are not required for employees 

who perform field work for a period of 

three hours or less (including 

transportation time to and from the 

field) during the day). 

As discussed in the QAR, the fecaloral route for contamination of food 

with pathogens is well-established and 

proper washing and drying of hands are 

fundamental practices demonstrated to 

be effective in breaking the fecal-oral 

route of contamination. Therefore, in 

proposed 112.129(c), we would 

establish requirements that you provide 

a hand-washing station during growing 

activities that take place in a fullyenclosed building, and during covered 

harvesting, packing, or holding 

activities, that is in sufficiently close 

proximity to toilet facilities to make it 

practical for persons who use the toilet 

facility to wash their hands. We discuss 

the importance of hand-washing in 

presenting the proposed requirements 

for hygienic practices in section V.D. of 

this document. 

The provisions in proposed § 112.129 

are consistent with recommendations in 

our GAPs Guide (Ref. 10), the AFDO 

Model Code (Ref. 20), commodityspecific 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 accessible hand-washing 

facilities during growing activities that 

take place in a fully-enclosed building, 

and during covered 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: Soap 

(or other effective surfactant) (proposed 

§ 112.130(b)(1)); running water that 

satisfies the requirements of § 112.44(a) 

for water used to wash hands (proposed 

§ 112.130(b)(2)); and adequate drying 

devices (such as single service towels, 

clean cloth towels or sanitary towel 

service) (proposed § 112.130(b)(3)). As 

discussed in the QAR, hand-washing is 

a key control measure in preventing the 

spread of pathogens from ill or infected 

workers to covered produce and foodcontact surfaces. Workers often touch 

produce with their bare hands. Handwashing, when done effectively, can 

significantly reduce the number of 

resident bacteria on the hands of a 

worker who may not be aware of being 

ill or infected, as well as transient 

microbial pathogens that get onto hands 

through contact with the environment 

or other ill workers. The effectiveness of 

hand-washing is determined by 

multiple factors, including whether or 

not soap is used, the quality of water 

used, the duration of scrubbing and 

rinsing, and whether and how hands are 

dried. The frequency of hand-washing, 

as well as the efficacy of a single handwashing event, may also be important 

factors in the spread of microbial 

pathogens by ill or contaminated 

workers (Ref. 107). 

Proposed subpart 112.130(c) would 

establish requirements that you provide 

for appropriate disposal of waste (for 

example, waste water and used singleservice towels) associated with a handwashing facility and take appropriate 

measures to prevent waste water from a 

hand-washing facility from 

contaminating covered produce, foodcontact surfaces, areas used for a 

covered activity, agricultural water 

sources, and agricultural water 

distribution systems with known or 

reasonably foreseeable hazards. A handwashing facility produces waste that can 

lead to contamination, and such waste 

needs to be controlled. For example, if 

the sink of a portable hand-washing 

station in field actively being harvested 

does not have a catch-basin or tank, but 

instead is open the ground, the wastewater from the sink can contaminate the 

soil. Finally, in proposed § 112.130(d), 

we would establish that you may not 

use hand antiseptic/sanitizer as a 

substitute for soap and water. As 

discussed in the QAR, hand sanitizers 

have not been found to be effective 

substitutes for washing hands with soap 

and water, because the presence of dirt, 

grease, or soil reduces their 

effectiveness in eliminating bacteria. 

However, we are not proposing to 

prohibit the use of sanitizers as they 

may be effective as an additional 

measure in reducing the number of 

bacteria on hands after proper washing 

with soap and water followed by drying 

The hand-washing provisions in 

proposed § 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 may contain pathogens in 

relatively high concentrations and, 

therefore, sewage must be properly 

disposed and sewage and septic systems 

must be maintained to minimize the 

potential for failure, leakage, or spills 

(and any leakage or spill appropriately 

managed) to prevent contamination of 

covered produce. Events such as 

flooding or earthquakes also have the 

potential to damage sewage and septic 

systems and impair their function and, 

therefore, it would be appropriate to 

assess your sewage systems for damage 

or other failures, following such events. 

Proposed § 112.131 would establish 

requirements that apply to the control 

and disposal of sewage, including that 

you must dispose of sewage into an 

adequate sewage or septic system or 

through other adequate means 

(proposed § 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, agricultural 

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 spills 

of human waste in a manner that 

prevents contamination of covered 

produce, and prevents or minimizes 

contamination of food-contact surfaces, 

areas used for a covered activity, 

agricultural water sources, or 

agricultural water distribution systems 

(proposed § 112.131(c)); and that after a 

significant event (such as flooding or an 

earthquake) that could negatively 

impact a sewage or septic system, you 

must take appropriate steps to ensure 

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that sewage and septic systems continue 

to operate in a manner that does not 

contaminate covered produce, foodcontact surfaces, areas used for a 

covered activity, agricultural water 

sources, or agricultural water 

distribution systems (proposed 

§ 112.131(d)). These provisions are 

consistent with recommendations in our 

GAPs Guide (Ref. 10), commodityspecific guidances (Ref. 44. Ref. 46), and 

the AFDO Model Code (Ref. 20). 

Proposed subpart 112.132 would 

establish requirements that apply to the 

control and disposal of trash, litter, and 

other waste in areas used for covered 

activities. Proposed § 112.132(a) would 

establish requirements that you convey, 

store, and dispose of trash, litter and 

waste to: (1) Minimize the potential for 

trash, litter, or waste to attract or harbor 

pests (proposed § 112.132(a)(1)); and (2) 

Protect against contamination of 

covered produce, food-contact surfaces, 

areas used for a covered activity, 

agricultural water sources, and 

agricultural water distribution systems 

with known or reasonably foreseeable 

hazards (proposed § 112.132(a)(2)). In 

addition, we propose to require that you 

adequately operate systems for waste 

treatment and disposal so that they do 

not constitute a potential source of 

contamination in areas used for a 

covered activity (proposed § 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 

with recommendations for packing areas 

in our GAPs Guide (Ref. 10), and 

commodity-specific guidance (Ref. 46). 

j. Plumbing 

Proposed § 112.133 would establish 

that plumbing must be of an adequate 

size and design and be adequately 

installed and maintained to (1) 

distribute water under pressure as 

needed, in sufficient quantities, in all 

areas where used for covered activities, 

for sanitary operations, or for handwashing and toilet facilities (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 surfaces, areas 

used for a covered activity, or 

agricultural water sources (proposed 

§ 112.133(c)); and (4) not allow backflow 

from, or cross connection between, 

piping systems that discharge waste 

water or sewage and piping systems that 

carry water used for a covered activity, 

for sanitary operations, or for use in 

hand-washing facilities (proposed 

§ 112.133(d)). An example of a problem 

that may result from inadequate 

plumbing is improper drainage of 

refrigeration drip pans. If drip pans do 

not drain properly, they may drip onto 

covered produce or allow moisture to 

accumulate providing an environment 

that can support the establishment of 

and growth of L. monocytogenes. 

Proposed § 112.133 is intended to 

ensure that your plumbing and water 

distribution systems do not adversely 

affect the water you use in covered 

activities on covered produce. If the 

plumbing and water distribution 

systems are not adequately installed and 

maintained, they may contaminate your 

water supply and, in turn, contaminate 

your covered produce through direct 

contact (such as when you use water in 

irrigation or harvest activities), or 

through indirect contact (such as when 

the contaminated water is used to wash 

a food-contact surface). Such crosscontamination of clean water and waste 

water has been implicated in outbreak 

investigations (Ref. 235). It would also 

be important to prevent contamination 

of water that must meet the 

requirements under subpart E by water 

that does not meet the relevant 

requirements. For example, water used 

for irrigation of covered produce other 

than sprouts using a direct water 

application method would need to meet 

the requirements of §§ 112.41 and 

112.44(c) or (d), but would not 

necessarily meet the requirements of 

§ 112.44(a) (see section V.E. of this 

document). These provisions are 

consistent 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 Litter 

From Domesticated Animals 

In proposed § 112.134(a), we would 

require that, if you have domesticated 

animals, to prevent contamination of 

covered produce, food-contact surfaces, 

areas used for a covered activity, 

agricultural water sources, or 

agricultural water distribution systems 

with animal waste, you must: (1) 

Adequately control their excreta and 

litter, and (2) maintain a system for 

control of animal excreta and litter. For 

example, you would comply with this 

provision by not locating manure piles 

adjacent to packing sheds in which 

covered produce is exposed. As 

discussed in the QAR, pathogens 

inhabit the gut of a variety of warmblooded animal species and are often 

shed in feces in high numbers. If not 

effectively controlled, such pathogens 

may persist in the environment for long 

periods of time (see the QAR) and may 

pose a threat to water quality from 

runoff and leaching (Ref. 236. Ref. 169), 

creating multiple opportunities for these 

pathogens to contaminate produce or 

food contact surfaces. 

l. Record Keeping 

Proposed § 112.140(a) would make 

clear that records required under this 

subpart L must be established and kept 

in accordance with the requirements of 

subpart O of this part. Records required 

to be established and kept under this 

subpart L include documentation of the 

date and method of cleaning and 

sanitizing of the equipment you use in 

growing operations for sprouts 

(proposed § 112.140(b)(1)) and in 

covered harvesting, packing, or holding 

activities (proposed § 112.140(b)(2)). 

These documentation requirements are 

intended to enable us to verify and you 

to ensure that requirements of this 

subpart are met. 

M. Subpart M—Standards Directed to 

Sprouts 

Proposed subpart M would establish 

science-based minimal standards for the 

growing, harvesting, packing and 

holding of sprouts that are reasonably 

necessary to minimize the risk of known 

or reasonably foreseeable hazards that 

are associated with serious adverse 

health consequences or death. As noted 

in section I of this document, sprouts 

have been frequently associated with 

foodborne illness outbreaks (Ref. 3). As 

a result, we issued our first commodityspecific guidance for sprouts. Likewise, 

the Codex Alimentarius Commission 

supplemented its Codex Fresh Fruits 

and Vegetables Code with a Sprout 

Annex (Ref. 50). 

Sprouts present a special concern 

with respect to human pathogens than 

other covered produce because of the 

warm, moist, and nutrient-rich 

conditions required to produce sprouts, 

the same conditions that are also ideal 

for the proliferation of pathogens if 

present (Ref. 208. Ref. 16). Therefore, we 

believe it is necessary to incorporate 

this additional subpart establishing 

standards specific to sprouts. The 

provisions of proposed subpart M are 

consistent with recommendations in 

FDA’s Sprout Guides (Ref. 14. Ref. 15), 

industry guidance (Ref. 237), and 

international regulations and guidelines 

(Ref. 38. Ref. 191. Ref. 192. Ref. 193). 

We are also seeking comment on 

whether, or to what extent, the measures 

in this subpart should be applied to soilgrown sprouts. The NACMCF Sprout 

White paper and our Sprout Guides do 

not distinguish soil-grown sprouts and 

hydroponic sprouts (Ref. 14. Ref. 15. 

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Ref. 16). However, we are not aware of 

any outbreaks associated with sprouts 

grown in soil or media, which could be 

because of the lower percentage of 

sprouts grown in that manner, the 

nature of the species of sprouts grown 

in that manner, or a difference in 

likelihood of contamination posed by 

that method and hydroponics. This 

could be the case because of the relative 

ease of transfer of pathogens between 

sprouts in a water environment and, 

possibly, a greater amplification of 

pathogens during hydroponic sprout 

production compared to the more 

stressful environment for pathogen 

growth posed by exposure to air and 

sunlight when seeds are grown under 

conditions more typical of a natural 

setting (soil and media methods). On the 

other hand, we expect that seeds or 

beans would be a potential vehicle of 

contamination, regardless of sprouting 

method employed. Seeds or beans (in 

the form of seed leaves or cotyledons) 

could be part of the food consumed, 

regardless of the method used for 

sprouting. In addition, flats of soil or 

media grown sprouts may be placed on 

a growing rack, similar to hydroponic 

sprouts grown in clamshells (as opposed 

to large bins for bean sprouts or rotating 

drums used to start green sprouts), with 

overhead sprout irrigation water, 

providing an opportunity for pathogens, 

if present, to be spread within a flat of 

sprouts and to other flats on racks 

below. Alternatively, flats may be 

placed side-by-side in a growing area 

such as a greenhouse, where the 

likelihood of pathogen spread would 

presumably be lower than when a 

growing rack is used. 

Finally, as discussed in section IV of 

this document, while we recommend 

that farms conduct an operational 

assessment and develop a food safety 

plan, at this time, we are not proposing 

to require them to do so. We request 

comment on whether, in a final rule, a 

food safety plan and/or an operational 

assessment should be required for farms 

conducting covered activities related to 

sprouts, either in addition to or in place 

of the standards proposed in this 

subpart. We also request comment on 

whether a written plan similar to the 

type required under section 418 of the 

FD&C Act would be more appropriate 

for farms conducting covered activities 

related to sprouts. 

1. Comments Relevant to the Proposed 

Provisions 

We received very few comments 

related specifically to sprouts. Those 

that were submitted were generally 

supportive of our efforts to create 

policies to prevent illness and produce 

safer sprouts, citing the need for 

addressing residual agricultural 

chemicals and microbial contamination 

of seed, seed disinfection treatments, 

worker health and hygiene, and 

sanitation. One comment hoped that we 

understood the realities currently facing 

the sprout industry worldwide, and 

would take actions to ensure truly 

practical measures that would be 

accepted by the sprout industry, 

questioning, for example, the need for 

extensive record keeping or monitoring 

sprout facilities for Listeria. This 

comment maintained that we should 

consider current production methods 

and consumption practices in 

establishing standards for sprouts. 

As discussed further in section V.M.3. 

of this document, our proposed rule 

carefully considers the various 

conditions under which sprouts are 

grown and consumed. The proposal 

provides flexibility to achieve the goal 

of minimizing the risk of known or 

reasonably foreseeable hazards that are 

associated with serious adverse health 

consequences or death. We consider 

that the proposed requirements for the 

growing, harvesting, packing and 

holding of sprouts, as well as for record 

keeping, are all practical and necessary 

to protect public health. With respect to 

consideration of the method of growth, 

as discussed above, we are seeking 

comment on whether soil-grown sprouts 

are subject to the same risk factors as 

hydroponic sprouts and to whether, or 

to what extent, the measures in this 

subpart should be applied to them. 

One comment recommended that 

bean sprouts be subjected to less 

stringent requirements compared to 

others, e.g., green sprouts, because bean 

sprouts are rarely consumed raw (less 

than 1% according to their estimates). 

This comment suggested that seed 

disinfection treatments might not be 

necessary (or argued for more 

disinfection method choices) for bean 

sprouts. Our 1999 Sprout Guides apply 

to all sprouted seeds and beans (Ref. 14. 

Ref. 15) and we are proposing in subpart 

M to cover all sprouts, including bean 

sprouts. Our earliest efforts to promote 

sprout safety, including consumer 

advisories, focused primarily on green 

sprouts, such as alfalfa and clover 

sprouts, where we were seeing sprout 

outbreaks and because we assumed bean 

sprouts were most often cooked before 

consumption (Ref. 238). However, in 

2002, we updated our consumer 

advisories to include advice on the risks 

associated with eating all types of 

sprouts, including raw and lightly 

cooked bean sprouts based on four 

foodborne illness outbreaks associated 

with mung bean sprouts between 2000 

and 2002 (Ref. 239). As noted in section 

V.A.2.a. of this document, we analyzed 

consumption of selected produce 

commodities to determine those that are 

rarely consumed raw. We included 

sprouts (alfalfa and mung bean) in our 

analysis, and based on data available 

from the NHANES, alfalfa and mung 

bean sprouts do not meet our criteria for 

rarely consumed raw commodities (Ref. 

79). 

2. Proposed Requirements 

Proposed § 112.141 would establish 

measures directed to seeds or beans 

used to grow sprouts. Seeds and beans 

used for sprouting are believed to be the 

vehicle for contamination in most E. coli 

O157:H7 and Salmonella foodborne 

illness outbreaks associated with 

sprouts (Ref. 3. Ref. 16). Proposed 

§ 112.141 is consistent with our Sprout 

Guide and other public and private 

programs (Ref. 50. Ref. 240). 

Proposed § 112.141(a) would require 

that, if you grow seeds or beans for use 

to grow sprouts, you must take measures 

reasonably necessary to prevent the 

introduction of known or reasonably 

foreseeable hazards into or onto seeds or 

beans that you will use for sprouting. 

These measures would need to be taken 

during growing, harvesting, packing, 

and holding of seeds and beans, which 

include such activities as cleaning, 

conditioning, and blending. 

Various crops may be grown to 

produce seeds and beans for sprouting 

with different production practices, 

growing seasons, conditions, and crop 

needs. Some of these plants set seeds or 

beans without intervention from 

growers, while others (such as alfalfa) 

may require steps, such as being cutback, to encourage seed set. Harvesting, 

packing, and holding may also vary by 

seed type and by the conditions needed 

to maintain seed quality, such as 

germination. Because of the diversity of 

practices, processes, and procedures, 

the controls reasonably necessary to 

prevent the introduction of known or 

reasonably foreseeable hazards into or 

onto seeds or beans that you use for 

sprouting may vary. Therefore, we are 

not proposing to prescribe specific 

measures that are reasonably necessary 

to prevent the introduction of known or 

reasonably foreseeable hazards into or 

onto seeds or beans. However, you may 

refer to our recommendations in 

relevant guidances (Ref. 14. Ref. 10). 

It is well-established that sprouts can 

become contaminated through the use of 

contaminated seeds for sprouting. 

Therefore, we considered proposing a 

supplier approval and verification 

program for seeds and beans received by 

sprouters for sprouting purposes. Such 

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3596 Federal Register / Vol. 78, No. 11 / Wednesday, January 16, 2013 / Proposed Rules 

a program would provide assurance that 

seeds or beans received from a third 

party for use to grow sprouts are grown, 

harvested, stored, and handled using 

measures reasonably necessary to 

prevent the introduction of known or 

reasonably foreseeable hazards into or 

onto seeds or beans used for sprouting. 

However, a supplier approval and 

verification program may not be 

practical or effective for seeds and beans 

received by sprouters for sprouting 

purposes. For example, for most crops, 

only a small percentage of the harvested 

seeds or beans goes to sprout production 

(Ref. 16. Ref. 241). Several distributors 

sell seeds and beans primarily for 

agricultural use with little or no sales 

for sprouting (Ref. 16). Seeds and beans 

have a relatively long shelf-life, 

sometimes being stored for a year or 

longer, and they often pass through a 

number of business entities before their 

final sale. Therefore, the ultimate end 

use of seeds and beans will likely not be 

known by many growers, handlers, or 

distributors (Ref. 16. Ref. 196. Ref. 192. 

Ref. 197). We are also not aware of any 

regulatory standards that include a 

supplier approval and verification 

program for seeds and beans received by 

sprouters for sprouting purposes. For 

example, Food Standards Australia New 

Zealand (FSANZ) considered but did 

not require such a program (Ref. 242). 

We ask for comment on this approach 

and whether there are additional 

practical steps or practices that can be 

taken to ensure the safety of seeds and 

beans used for sprout production. 

Specifically, we request comments on 

whether a supplier approval and 

verification program for seeds and beans 

intended for sprout production is 

practical and effective. 

We also considered whether to 

propose a requirement that you test 

incoming seeds and beans, and rejected 

this approach. Although 

epidemiological investigations often 

identify seeds and beans as the most 

likely source of contamination, 

contamination may be at very low levels 

(4 CFU/kg seed) (Ref. 16) and laboratory 

analyses have frequently been unable to 

isolate pathogens from implicated seeds 

or beans (Ref. 243). In a recent EFSA 

publication, the authors concluded that 

a 2-class sampling plan ‘‘absence in 

25g’’, n=5; c=0, as specified in EC 

Regulation 2073/2005 for sprouted 

seeds, will not give sufficient 

confidence to demonstrate the absence 

of a target pathogen at these low levels 

in seeds. To increase the probability of 

rejection of a positive lot, the authors 

estimated that it would be necessary to 

analyze kilogram quantities of the 

sample (Ref. 244). Guidances from 

Canadian and Irish authorities include 

recommendations that seeds and beans 

be tested by the distributor, and that the 

sprouter obtain a Certificate of Analysis 

(CoA) for the seeds and beans (Ref. 240. 

Ref. 245), but recognize the limitations 

of testing seeds. 

While a negative test result is not a 

guarantee of the absence of pathogens, 

a positive test result would facilitate 

detection of contaminated seeds and 

beans for destroying or diverting to nonfood use. Thus, we would encourage 

seed suppliers and sprouters to test seed 

using statistically valid sampling and 

testing protocols. However, we 

tentatively conclude that testing seeds 

and beans is not sufficiently reliable to 

include as a measure necessary to 

prevent the introduction of known or 

reasonably foreseeable hazards. Instead, 

we propose to focus on seed treatment 

(proposed § 112.142) and testing spent 

irrigation water from each production 

batch of sprouts (or testing each 

production batch of sprouts at the inprocess stage when testing spent 

irrigation water is not practicable) 

(proposed § 112.143). 

When seeds or beans are used to 

produce sprouts, they are ‘‘food,’’ as 

defined in section 201(f) of the FD&C 

Act (Ref. 95). The definition of ‘‘food’’ 

in proposed § 112.3 is consistent with 

this interpretation. When you grow, 

harvest, pack, and store seeds and beans 

for sprouting at your operation, you 

know the end use of the seeds and 

beans, and proposed § 112.141(a) would 

require that you exercise control over 

that input into your sprout production. 

On the other hand, growers of seeds and 

beans may be unaware as to whether 

their crop will be used for sprout 

production. We seek comment on any 

provisions that would be effective in 

reducing the risk posed by 

contaminated seeds or beans in such 

cases, without also imposing an undue 

burden on the agricultural sector that 

produces seed used primarily for 

purposes of growing food or feed crops 

and not intended for use as food for 

human consumption as sprouts. 

Proposed § 112.141(b) through (c) 

would establish additional requirements 

to ensure that seeds and beans do not 

serve as a vehicle for introducing 

contamination in sprouts. Proposed 

§ 112.141(b) would require that if you 

know or have reason to believe that a lot 

of seeds or beans has been associated 

with foodborne illness, you must not 

use that lot of seeds or beans to produce 

sprouts. Contamination of seeds and 

beans is generally at a low level and not 

distributed homogeneously throughout 

a seed lot. Thus, a seed lot may be in 

distribution for some time and in use by 

multiple sprout farms before it is known 

or suspected to be contaminated. As 

discussed in the QAR, we are aware of 

outbreaks associated with multiple 

sprout farms using the same lot of seed. 

In addition, pathogens, such as 

Salmonella and E. coli O157:H7, can 

survive for an extended period of time 

on seeds and beans, as evidenced by 

outbreaks linked to seed that is a year 

or two old, so setting aside a potentially 

contaminated seed lot for later use does 

not reduce the likelihood of producing 

contaminated sprouts from that lot of 

seeds or beans (Ref. 16. Ref. 243). For 

these reasons, we have tentatively 

concluded that, once you know or have 

reason to believe that a lot of seeds or 

beans is contaminated, through 

microbial testing or implication as the 

vehicle in an outbreak, there is reason 

to believe that other parts of that lot may 

also be contaminated, you must not use 

that lot of seeds or beans to produce 

sprouts. This is consistent with existing 

guidances and standards (Ref. 16. Ref. 

18. Ref. 192. Ref. 193). 

Proposed § 112.141(c) would require 

that you visually examine seeds and 

beans, and packaging used to ship seeds 

or beans, for signs of potential 

contamination with known or 

reasonably foreseeable hazards. Visual 

examination of seeds and beans for 

sprouting, and the packaging used to 

ship them, provides an opportunity to 

see signs of potential contamination, 

such as rodent or bird feces or urine, 

which may introduce pathogens into or 

onto sprouts (Ref. 241. Ref. 246). Feces 

from rodents and birds are known to 

carry pathogens (Ref. 247). This 

proposed provision is consistent with 

recent FDA and international guidance 

(Ref. 38. Ref. 18. Ref. 192. Ref. 193). 

Proposed § 112.142 would establish 

measures you must take for growing, 

harvesting, packing, and holding 

sprouts. Specifically, proposed 

§ 112.142(a) would require that you 

grow, harvest, pack, and hold sprouts in 

a fully-enclosed building. Proposed 

§ 112.142(b) would require that any 

food-contact surfaces you use to grow, 

harvest, pack, or hold sprouts must be 

sanitized after cleaning and before 

contact with sprouts or seeds or beans 

used to grow sprouts. As discussed in 

the QAR, although the source of 

contamination in outbreaks associated 

with sprouts has most often been 

incoming seeds or beans, pathogens can 

also be introduced during sprout 

growing, harvesting, packing, and 

holding. 

Therefore, we are proposing these 

additional requirements for sprout farms 

(i.e., conducting operations in a fully 

enclosed building, sanitizing foodmstockstill on DSK4VPTVN1PROD with 

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contact surfaces after cleaning) because 

we have tentatively concluded that the 

sprouting process represents a unique 

bacterial amplification step that requires 

a higher level of care compared to the 

growing, harvesting, packing, and 

holding of other covered produce. This 

proposed approach, a higher level of 

care compared to produce growing, 

harvesting, packing and holding 

generally, is consistent with Codex 

guidelines (Ref. 50). 

Proposed § 112.142(c) would require 

you to treat seeds or beans that will be 

used to grow sprouts using a 

scientifically valid method immediately 

before sprouting to reduce 

microorganisms of public health 

significance. Consistent with our 

previous discussion of the term 

‘‘scientifically valid’’ with respect to 

testing in the proposed rule to establish 

Current Good Manufacturing Practice 

requirements for dietary ingredients and 

dietary supplements (68 FR 12157 at 

12198), we use the term ‘‘scientifically 

valid’’ to mean using an approach that 

is based on scientific information, data, 

or results published in, for example, 

scientific journals, references, text 

books, or proprietary research. Methods 

used for reducing microorganisms of 

public health significance in seeds or 

beans for sprouting must be 

scientifically valid if they are to provide 

assurance that they are effective. 

Prior treatment conducted by a 

grower, handler, or distributor of seeds 

or beans, does not eliminate your 

responsibility to treat seeds or beans 

immediately before sprouting, at your 

covered farm. This proposed 

requirement is consistent with 

NACMCF recommendations and our 

Sprout Guide (Ref. 16. Ref. 14) and 

international guidance (Ref. 193. Ref. 

191. Ref. 38). Specifically, NACMCF 

recommends that seed treatments that 

deliver less than a 5-log pathogen 

reduction be coupled with a microbial 

testing program. We did not cite any 

specific log reduction in our Sprout 

Guide as ‘‘adequate to reduce 

pathogens.’’ At that time, few if any 

seed treatments were thought to be 

capable of consistently delivering a 5- 

log pathogen reduction. 

A number of treatments have been 

shown to reduce levels of, but not 

eliminate, pathogenic bacteria present 

on seeds. Such treatments are likely to 

reduce the level of contamination if 

present and, in turn, decrease the risk 

for foodborne disease with sprouted 

seeds (Ref. 16). We cited in the Sprout 

Guide a 20,000 ppm calcium 

hypochlorite treatment as an example of 

a treatment that has been shown to be 

effective for the reduction of pathogens 

on seed. Scientific literature indicates 

that the 20,000 ppm Ca(OCl)2 treatment, 

widely adopted by sprouters who treat 

seed prior to sprouting, produces a 2.5 

log reduction, with a range of 1.0–6.5 

log reduction (Ref. 192. Ref. 201). Other 

chemical and physical seed disinfection 

treatments, alone and in combination, 

have been evaluated for efficacy but 

there is a high degree of variability in 

research results based on a number of 

factors (e.g., seed type, whether seed 

was naturally or artificially 

contaminated, level of initial 

contamination). In their evaluation of 

the current state of microbiological 

safety of seeds and sprouts, Fett et al. 

(Ref. 243) present a comparison of the 

efficacy of select aqueous chemical 

disinfection treatments with Ca(OCl)2

for sanitizing alfalfa seed from the 

literature. Canada recommends a lower 

level of calcium hypochlorite, 2,000 

ppm (Ref. 245). 

We acknowledge that several 

outbreaks have brought into question 

the effectiveness of seed disinfection 

treatments. For example, an outbreak of 

Salmonella kottbus in alfalfa sprouts 

was linked to seed that underwent a 

chlorine sanitization step, although 

records indicate the concentration of 

chlorine was probably lower than the 

recommended 20,000 ppm (Ref. 248). 

Conversely, in 1999, an outbreak of 

Salmonella enterica serotype Mbandaka 

occurred in Oregon, Washington, Idaho, 

and California. Based on epidemiologic 

and pulsed-field gel electrophoresis 

evidence from 87 confirmed cases, the 

outbreak was linked to contaminated 

alfalfa seeds grown in California’s 

Imperial Valley. Trace-back and traceforward investigations identified a 

single lot of seeds used by five sprout 

growers during the outbreak period. 

Cases of salmonellosis were linked with 

two sprout growers who had not 

employed chemical disinfection; no 

cases were linked to the three sprout 

growers who used seed disinfection 

(Ref. 249). In another outbreak of 

Salmonella typhimurium in clover 

sprouts linked to seed sold to multiple 

sprout operations, sprouters who had 

treated the seeds in 20,000 ppm 

chlorine had fewer cases attributed to 

their sprouts compared to those that did 

not (Ref. 250). This is consistent with 

modeling work by Montville and 

Schaffner, indicating that, while 

disinfection of seeds prior to sprouting 

did not guarantee pathogen free sprouts, 

disinfection reduced the percentage of 

contaminated batches. Seed disinfection 

was most effective when contamination 

was sporadic and at low levels; at a low 

prevalence (1 out of 10,000 25-g samples 

are positive), as would normally be 

expected, the percentage of 

contaminated batches was reduced from 

13.7 to 0.1%. Where the initial 

contamination was high and uniform, 

the proportion of contaminated batches 

was reduced only from 100 to 87.7% 

(Ref. 251). 

For these reasons we continue to 

believe that seed disinfection treatments 

are valuable as one of several measures 

necessary to ensure the safety of 

sprouts. We ask for comment on this 

approach. 

Proposed § 112.143 would establish 

requirements for testing procedures you 

apply to the growing, harvesting, 

packing, and holding of sprouts. 

Specifically, proposed § 112.143(a) 

would require that you test the growing, 

harvesting, packing, and holding 

environment for Listeria spp. or L. 

monocytogenes (Lm) in accordance with 

the requirements of § 112.144. The 

proposed testing requirement in 

§ 112.143(a) is in response to emerging 

concerns about positive sample findings 

and multiple recalls associated with L. 

monocytogenes in sprouts (Ref. 17. Ref. 

252). Between 2002 and 2010, there 

have been 10 recalls involving multiple 

sprout types due to potential or 

confirmed contamination with L. 

monocytogenes (Ref. 253). In one of 

these recalls, the strain found in sprouts 

matched the strain isolated from 20 

confirmed cases of listeriosis in 6 States 

and positive sample findings from an 

environmental investigation at the 

sprouting operation (Ref. 252). 

Contamination from L. 

monocytogenes from the environment is 

common (Ref. 207) and, thus, targeted 

preventive controls to minimize L. 

monocytogenes in RTE foods are 

warranted. While appropriate sanitation 

measures can minimize the presence of 

environmental pathogens in a sprouting 

operation, we tentatively conclude that 

environmental monitoring is still 

necessary for sprouting operations as an 

added safety measure. Such monitoring 

can be conducted by testing for the 

specific pathogenic microorganism or by 

testing for an ‘‘indicator organism,’’ 

which can indicate conditions in which 

the environmental pathogen may be 

present. Typically, a firm that finds an 

indicator organism during 

environmental monitoring conducts 

microbial testing of surrounding 

surfaces and areas to determine the 

potential source of the contamination, 

cleans and sanitizes the contaminated 

surfaces and areas, and conducts 

additional microbial testing to 

determine whether the contamination 

has been eliminated. Further steps may 

be necessary if the indicator organism is 

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3598 Federal Register / Vol. 78, No. 11 / Wednesday, January 16, 2013 / Proposed Rules 

found on retest. Tests for the indicator 

organism Listeria spp. detect multiple 

species of Listeria, including the 

pathogen L. monocytogenes. For 

example, USDA’s FSIS regulations and 

guidelines use Listeria spp. as an 

appropriate indicator organism for L. 

monocytogenes in for RTE meat or 

poultry products exposed to the 

processing environment after cooking to 

prevent product adulteration by L. 

monocytogenes (Ref. 254). FDA’s 

current thinking is that Listeria spp. is 

an appropriate indicator organism for L. 

monocytogenes, because tests for 

Listeria spp. will detect multiple species 

of Listeria, including L. monocytogenes, 

and because the available information 

supports a conclusion that modern 

sanitation programs, which incorporate 

environmental monitoring for Listeria 

spp., have public health benefits. The 

taking of actions based on the presence 

of an appropriate indicator organism is 

protective of public health, since there 

will be times when steps are taken in 

the absence of the pathogen. Therefore, 

we tentatively conclude that testing the 

growing, harvesting, packing and 

holding environment for Listeria spp. or 

L. monocytogenes is a necessary 

measure to ensure the safety of sprouts. 

Proposed § 112.143(b) would require 

that you either: (1) Test spent sprout 

irrigation water from each production 

batch of sprouts for E. coli O157:H7 and 

Salmonella spp. in accordance with the 

requirements of § 112.146; or (2) if 

testing spent sprout irrigation water is 

not practicable (for example, for soilgrown sprouts), that you test each 

production batch of sprouts at the inprocess stage (i.e., while sprouts 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 

irrigation water for the sprouts would be 

considered adulterated under Section 

402(a)(4) of the FD&C Act, in that it has 

been prepared, packed, or held under 

insanitary conditions whereby it may 

have been rendered injurious to health. 

A production batch for which either of 

these pathogens is detected in the 

sprouts would be considered 

adulterated under Sections 402(a)(1) of 

the FD&C Act, in that the sprouts 

contain a poisonous or deleterious 

substance which may render it injurious 

to health. Therefore, we tentatively 

conclude that microbiological testing of 

spent irrigation water from each 

production lot (or of each production 

batch of sprouts) is necessary to provide 

reasonable assurances that sprouts are 

not adulterated under Section 402 of the 

FD&C Act. The proposed testing 

requirement in § 112.143(b) to test spent 

sprout irrigation water (or sprouts) for 

Salmonella and E. coli O157:H7 would 

codify current recommendations in our 

Sprout Guides and is consistent with 

existing international guidelines and 

regulations (Ref. 38. Ref. 191. Ref. 193). 

We are proposing these testing 

requirements in § 112.143(b) in addition 

to the proposed treatment requirements 

in § 112.142(c) because pathogens that 

are merely injured, but not killed, by 

seed treatment could potentially grow 

out again when subjected to enrichment 

conditions, as experienced during 

sprouting (Ref. 16. Ref. 74). Because 

seed disinfection treatments can reduce, 

but may not eliminate, pathogens on 

seed, we are proposing to require 

microbiological testing. Spent irrigation 

water that has flowed over and through 

sprouts is a good indicator of the types 

and quantities of microorganisms in the 

sprouts themselves (differing by only 1 

log or less from the level in the sprouts) 

and the microflora in spent irrigation 

water is fairly homogeneous (Ref. 15. 

Ref. 198. Ref. 209). The optimal time for 

testing is when pathogen levels are 

highest (approximately 24–48 hours 

after the start of sprouting), but also 

when it is early enough in the sprouting 

process to obtain results before product 

is shipped. 

We have emphasized testing irrigation 

water in proposed § 112.143(b) because 

testing sprouts has several significant 

disadvantages compared to testing spent 

irrigation water. First, contamination of 

sprouts is not likely to be as 

homogeneous as is the spent irrigation 

water (Ref. 243. Ref. 255). Second, 

multiple sprout samples must be taken 

from different locations in the drum or 

trays to ensure that the sample collected 

is representative of the batch. 

Furthermore, additional preparation 

(e.g., selecting representative 

subsamples for analyses, blending or 

stomaching) is required when testing 

sprouts. Each additional step introduces 

a possibility for error. Consequently, 

testing of spent sprout irrigation water 

is generally preferred over testing 

sprouts unless production methods 

make it impractical to test spent sprout 

irrigation water. For example, spent 

irrigation water may not be available 

when sprouts are grown in soil. 

We chose pathogen testing for 

Salmonella spp. and E. coli O157:H7 

because these pathogens are the two 

most common agents in sproutassociated outbreaks in the U.S. (Ref. 3). 

Recently, EFSA concluded that there are 

currently no indicator organisms that 

can effectively substitute for the testing 

of pathogens in seeds, sprouted seeds or 

irrigation water (Ref. 244). We 

tentatively concur with this conclusion. 

In developing our Sprout Guides in 

1999 and in deliberations for this 

proposed rule, we also considered 

whether to include testing spent sprout 

irrigation water for L. monocytogenes, in 

addition to testing it for Salmonella spp. 

and E. coli O157:H7. However, we 

tentatively concluded that testing spent 

sprout irrigation water for Listeria has a 

number of potential challenges. The 

warm, moist, nutrient-rich conditions 

during sprouting encourage the 

proliferation of Salmonella and E. coli 

O157:H7 and this proliferation increases 

the probability of their detection, if 

present. In contrast, Listeria may be a 

poor competitor at the warmer 

temperatures and against the high level 

of native microflora present during the 

sprouting process. In addition, Listeria 

is ubiquitous. We would expect frequent 

positives using rapid tests for Listeria 

spp., which would not necessarily mean 

pathogens were present. Such testing 

would need to be followed by 

confirmatory testing to determine 

whether or not L. monocytogenes was 

present in order to determine 

appropriate actions with respect to the 

product. While rapid test kits are now 

available to screen for L. 

monocytogenes, their use on spent 

sprout irrigation water or sprouts would 

need to be validated (Ref. 14). We 

tentatively conclude that environmental 

monitoring for Listeria spp. or L. 

monocytogenes is the most practical 

approach for control of this pathogen. 

We request comments on this tentative 

conclusion. 

We also considered the 

appropriateness of proposing provisions 

for testing spent sprout irrigation water 

for non E. coli O157:H7 shiga toxinproducing E. coli (STEC) which were 

involved in the recent large sprout 

associated E. coli O104 foodborne 

illness outbreak in Europe (Ref EU OB). 

The O104:H4 strain that caused the 

outbreak in Europe was an unusual 

strain that none of the tests that were 

being used to test for 

enterohaemorrhagic E. coli (EHEC) at 

that time would have picked it up. The 

challenge is that there are estimated to 

be 400 serotypes of E. coli that produces 

any one of the 3 Stx1 and/or 8 Stx2 

subtypes and many of these are isolated 

from environmental and animal sources 

but have not been implicated in human 

illness. Many of the STEC strains 

entailed tedious plating and retesting to 

isolate and even longer to serotype (Ref. 

256). For these reasons, we tentatively 

conclude that proposing to require 

testing spent sprout irrigation water for 

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non E. coli O157:H7 STECs would not 

be a practical approach at this time. 

We request comments on this 

tentative conclusion, and on whether 

pathogens in addition to E. coli O157:H7 

and Salmonella spp. should be included 

in testing of spent sprout irrigation 

water or in-process sprouts, either by 

specifically listing the additional 

pathogens or by set criteria (e.g., 

association with one or more outbreaks 

linked to sprouts) for inclusion. 

Proposed § 112.144 would establish 

requirements 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 

directed to sampling and testing for 

Listeria spp. or L. monocytogenes. 

Proposed § 112.144(c)(1) through (3) 

would require that your written 

environmental monitoring plan include 

a sampling plan that specifies: What you 

will test collected samples for (i.e., 

Listeria spp. or L. monocytogenes) 

(proposed § 112.144(c)(1)); How often 

you will collect environmental samples, 

which 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 effective and must include 

appropriate food-contact surfaces and 

non-food-contact surfaces of equipment, 

and other surfaces within the growing, 

harvesting, packing, and holding 

environment (proposed § 112.144(c)(3)). 

Proposed § 112.144(d) would require 

you to collect 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 monitoring 

to be conducted with sufficient 

frequency to detect the environmental 

pathogen or appropriate indicator 

organism if present. We tentatively 

conclude that monthly sampling and 

testing is a minimum requirement 

(proposed § 112.144(c)(2)). More 

frequent testing may be needed. For 

example, the frequency of monitoring 

for environmental pathogens should 

increase as a result of finding the 

environmental pathogen or an indicator 

of the environmental pathogen or as a 

result of situations that pose an 

increased likelihood of contamination, 

e.g., construction (Ref. 211. Ref. 212). 

The frequency of taking environmental 

samples will vary depending on existing 

data on the presence of the 

environmental pathogen of concern in 

the environment where foods are 

exposed to the environment. In the 

absence of information, data should be 

generated to assist in determining the 

frequency of monitoring (Ref. 257). We 

request comment on whether the 

minimum frequency of at least monthly 

for environmental monitoring is 

adequate to assess whether the measures 

taken to minimize the risk associated 

with L. monocytogenes in sprouts are 

effective. We tentatively conclude that 

specifying the frequency of testing in 

the written environmental monitoring 

plan is necessary to enable assurance by 

the operator and verification by FDA 

that testing efforts are consistent with a 

carefully thought through effort to find 

the environmental pathogen if it is 

present in the environment. 

The purpose of environmental 

monitoring is to verify the 

implementation and effectiveness of 

sanitation measures for controlling the 

presence of L. monocytogenes in the 

sprout production environment. The 

monitoring must be designed to find 

environmental pathogens that remain in 

the sprouting operation after routine 

cleaning and sanitizing procedures in 

order to prevent contamination of 

product that could lead to illness. To 

accomplish this purpose, there must be 

a scientific basis for the locations 

selected for sampling, the number of 

samples taken, the frequency of 

sampling, the sampling procedures used 

and the test methodology. The sampling 

must be biased—i.e., the locations to be 

tested must be those in which the 

environmental pathogens can enter the 

environment where the food is exposed 

and those areas where harborage of the 

pathogen is likely (Ref. 258). 

One approach to defining sampling 

locations is to divide the sprouting 

operation into zones based on the 

likelihood of contamination of the 

product. A common industry practice is 

to use four zones (Ref. 213. Ref. 212): 

Zone 1 consists of food-contact surfaces; 

Zone 2 consists of non-food-contact 

surfaces in close proximity to food and 

food-contact surfaces; Zone 3 consists of 

more remote non-food-contact surfaces 

that are in the area used for growing, 

harvesting, packing, and holding and 

could lead to contamination of zones 1 

and 2; and Zone 4 consists of non-foodcontact surfaces, outside of the area 

used for growing, harvesting, packing, 

and holding from which environmental 

pathogens can be introduced into the 

growing, harvesting, packing, and 

holding environment. Generally the 

number of samples and frequency of 

testing is higher in zones 1 and 2 

because of the greater likelihood of food 

contamination if the environmental 

pathogen is present in these zones. 

Information on appropriate locations for 

sampling within these zones can be 

found in the literature (Ref. 175. Ref. 

212). Operators should become familiar 

with locations in which environmental 

pathogens have been found in other 

sprout firms and use this information in 

selecting sites to sample. 

L. monocytogenes frequently 

establishes itself in a harborage site on 

equipment and grows (increases in 

number) there, where both food and 

moisture are available. L. 

monocytogenes organisms work their 

way out of the harborage site during 

production and contaminate food. 

Testing food-contact surfaces for Listeria 

spp. is a commonly recommended 

verification measure for firms producing 

refrigerated RTE foods (Ref. 175. Ref. 

211). 

Examples of appropriate non-foodcontact surfaces that could be monitored 

include exteriors of equipment, 

equipment supports, control panels, 

door handles, floors, drains, 

refrigeration units, ducts, overhead 

structures, cleaning tools, and motor 

housings. Standing water in growing, 

harvesting, and packing areas and areas 

that have become wet and then have 

dried are also appropriate places to 

monitor. Testing non-food-contact 

surfaces for L. monocytogenes or Listeria 

spp. is a commonly recommended 

verification measure for firms producing 

refrigerated or frozen RTE foods (Ref. 

258. Ref. 259) and can detect L. 

monocytogenes that is brought into the 

plant by people or objects. Actions you 

then take can prevent transferring the 

organisms to a food-contact surface 

(where they can contaminate food) or 

from establishing a harborage that can 

serve as a source of contamination. 

Proposed § 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. 

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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 microbial sampling and 

testing to determine whether the Listeria 

spp. or L. monocytogenes has been 

eliminated (proposed § 112.145(c)); 

Conduct finished product testing when 

appropriate (proposed § 112.145(d)); 

and Perform any other actions necessary 

to prevent reoccurrence of the problem 

(proposed § 112.145(e)). Testing the 

environment of a sprouting operation 

for L. monocytogenes (or for Listeria 

spp. as an indicator of potential 

contamination with L. monocytogenes), 

and taking actions to eliminate L. 

monocytogenes or Listeria spp. when 

found in the environment of a sprouting 

operation, is an important component of 

controlling microorganisms of public 

health significance (Ref. 175. Ref. 211). 

The actions we are proposing to require, 

including additional testing to 

determine the extent of contamination, 

ensuring contamination is eliminated 

and taking steps to prevent its 

recurrence, are consistent with 

recommendations in our Listeria Guide 

(Ref. 260). 

If an environmental pathogen or an 

appropriate indicator organism (the test 

organism) is detected in the 

environment, steps must be taken to 

eliminate the organism, including 

finding a harborage site if one exists 

(Ref. 175. Ref. 211) (Ref. 257). 

Otherwise, the presence of the 

environmental pathogen could result in 

contamination of food-contact surfaces 

or food. The presence of the indicator 

organism suggests that conditions exist 

in which the environmental pathogen 

may be present and could result in 

contamination of food-contact surfaces 

or food. Actions must be taken for every 

finding of an environmental pathogen or 

indicator organism in the environment 

to prevent contamination of foodcontact surfaces or food. 

Sampling and microbial testing from 

surfaces surrounding the area where the 

test organism was found (proposed 

§ 112.145(a)) are necessary to determine 

whether the test organism is more 

widely distributed than on the original 

surface where it was found and to help 

find the source of contamination if other 

sites are involved. Cleaning and 

sanitizing the contaminated surfaces 

and surrounding areas (proposed 

§ 112.145(b)) are necessary to eliminate 

the test organism that was found there. 

Additional 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 indicates that 

the initial cleaning was not effective, 

and additional, more intensified 

cleaning and sanitizing, or other actions 

may be needed, including dismantling 

equipment, scrubbing surfaces, and 

heat-treating equipment parts (Ref. 207). 

The finding of a test organism on a foodcontact surface usually represents 

transient contamination rather than a 

harborage site (Ref. 259). However, 

finding the test organism on multiple 

surfaces in the same area, or continuing 

to find the test organism after cleaning 

and sanitizing the surfaces where it was 

found, suggests a harborage site for the 

test organism. Mapping the location of 

contamination sites, whether the 

harborage site is on equipment or in the 

environment, can help locate the source 

of the harborage site or identify 

additional locations to sample (Ref. 

257). 

Proposed § 112.145 would not specify 

how certain actions must be performed, 

such as the number of sites to test when 

the test organism is found in a sprouting 

operation, or how to clean and sanitize 

the surfaces on which the test organism 

was detected. The number of sites 

appropriate for testing and the 

applicable cleaning and sanitizing 

procedures will depend on the 

sprouting operation and the equipment. 

We tentatively conclude that, when 

microbial testing is conducted as part of 

steps in light of the results of 

environmental monitoring, specifying 

such procedural requirements would 

not provide facilities with sufficient 

flexibility to develop and implement 

aggressive and appropriate actions to 

find and eliminate the source of the 

contamination in the environment. Such 

actions may involve investigative 

procedures when the initial measures 

have not been successful in eliminating 

the environmental pathogen or indicator 

organism. One example of an 

investigative procedure is taking 

samples from food-contact surfaces and/ 

or produce at multiple times during the 

day while the equipment is operating 

and producing product (Ref. 207). 

Proposed § 112.145(d) would require 

that if environmental monitoring 

identifies the presence of an 

environmental pathogen or indicator 

organism, the operator conduct finished 

product testing, when appropriate. As 

discussed in section IV.I. of this 

document, there are shortcomings for 

microbiological testing of food for 

process control purposes. Testing 

cannot ensure the absence of a hazard, 

particularly when the hazard is present 

at very low levels and is not uniformly 

distributed. If an environmental 

pathogen is detected on a food-contact 

surface, finished product testing would 

be appropriate only to confirm actual 

contamination or assess the extent of 

contamination, because negative 

findings from product testing could not 

adequately assure that the 

environmental pathogen is not present 

in food exposed to the food-contact 

surface. If you detect an environmental 

pathogen on a food-contact surface, the 

sprouting operation should presume 

that the produce is adulterated under 

Section 402(a)(4) of the FD&C Act. 

Finished product testing could be 

appropriate if an environmental 

pathogen is detected on a non-foodcontact 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-foodcontact surface is generally low, but 

transfer from non-food-contact surfaces 

to food contact surfaces can occur. 

Finished product testing can provide 

useful information on the overall risk of 

a food when pathogens have been 

detected in the environment. 

Proposed § 112.145(e) would require 

that if environmental monitoring 

identifies the presence of an 

environmental pathogen or appropriate 

indicator organism, the operator 

perform any other steps necessary to 

prevent recurrence of the 

contamination. Actions taken as a result 

of monitoring for an environmental 

pathogen or an indicator organism for 

such pathogen must ensure these 

requirements are met. The measures for 

environmental monitoring specified in 

proposed § 112.145(a) through (d) are 

not all inclusive. Examples of measures 

that may be necessary include 

reinforcing employee hygiene practices 

and traffic patterns; repairing damaged 

floors; eliminating damp insulation, 

water leaks, and sources of standing 

water; replacing equipment parts that 

can become harborage sites (e.g., hollow 

conveyor rollers and equipment 

framework), and repairing roof leaks 

(Ref. 180. Ref. 219). Additional 

information on measures for 

environmental monitoring can be found 

in the literature (Ref. 180. Ref. 221. Ref. 

219). Proposed § 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. Specifically, proposed 

§ 112.146(a) would require that you 

establish and implement a written 

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sampling plan that identifies the 

number and location of samples (of 

spent sprout irrigation water or sprouts) 

to be collected for each production 

batch of sprouts to ensure that the 

collected samples are representative of 

the production batch when testing for 

contamination. Additionally, proposed 

§ 112.146(b) would require that, in 

accordance with the written sampling 

plan required under paragraph (a) of 

this section, you aseptically collect 

samples of spent sprout irrigation water 

or sprouts, and test the collected 

samples for E. coli O157:H7 and 

Salmonella spp. using a method that has 

been validated for its intended use 

(testing spent sprout irrigation water or 

sprouts) to ensure that the testing is 

accurate, precise, and sensitive in 

detecting these pathogens. This 

proposed provision is consistent with 

recommendations in our Sprout Testing 

Guide, the Canada and Irish Codes and 

the FSANZ standard (Ref. 15. Ref. 206. 

Ref. 201. Ref. 203). 

One means to test for E. coli O157:H7 

and Salmonella spp. as required under 

proposed § 112.146(b) is to follow our 

guidance on sampling and testing spent 

irrigation water or sprouts (Ref. 15). The 

methods described in our guidance have 

been validated to be effective on spent 

sprout irrigation water and sprouts (Ref. 

15. Ref. 223. Ref. 224). The effectiveness 

of detection methods can vary 

depending on multiple factors, 

including but not limited to whether the 

sample tested is representative of the 

food, type of food, level of microflora 

present, the enrichment procedure and 

type of test used. Spent sprout irrigation 

water and sprouts have a high level of 

natural microflora that can interfere 

with detection (Ref. 15. Ref. 243). 

Therefore, other methods that have been 

validated to be effective for other foods 

may not work for spent sprout irrigation 

water and sprouts. Because the 

microflora in spent sprout irrigation 

water is more homogeneous compared 

to seeds or sprouts, sampling 

procedures described in our guidance 

for sprout irrigation water are relatively 

simple. In addition, spent sprout 

irrigation water can be used directly in 

the test procedures described in our 

guidance, thus reducing the possibility 

of error (Ref. 15. Ref. 243). Sampling 

spent sprout irrigation water or sprouts 

is an important testing procedure to 

ensure contaminated product does not 

enter commerce. The testing procedures 

described in our guidance give accurate 

results as quickly and simply as 

possible on the presence or absence of 

E. coli O157:H7 and Salmonella spp. 

Proposed § 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 

requirements applicable to all records. 

Proposed § 112.150(b) would require 

you to establish and keep the following 

records: Documentation of your 

treatment of seeds or beans to reduce 

microorganisms of public health 

significance in the seeds or beans, at 

your farm (proposed § 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 plan 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 lieu 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 operations in order to 

help document your compliance with 

the provisions of this rule. We 

tentatively conclude that such records 

are needed for us to verify and you to 

ensure that appropriate measures are 

being followed consistently and 

correctly (e.g., your sampling plan for 

spent sprout irrigation water from each 

production lot). The records would also 

allow FDA or you to identify trends that 

might signal a need to adjust the 

measures in your environmental 

monitoring plan to improve its 

effectiveness and reliability (e.g., test 

results from your environmental 

monitoring program may signal the need 

to enhance sprouting operation cleaning 

and sanitation). 

N. Subpart N—Analytical Methods 

Proposed subpart N would specify 

methods of analysis for testing the 

quality of water and the growing 

environment for sprouts, as required 

under proposed subparts E and M (see 

sections V.E. and V.M., respectively, of 

this document). 

Proposed § 112.151 would establish 

that you must test 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) standards 

methods for the examination of water 

and wastewater as published by the 

American Public Health Association; or 

(3) methods prescribed in the FDA 

Bacteriological Analytical Manual, or by 

another method that is at least 

equivalent to the above-mentioned three 

methods in accuracy, precision and 

sensitivity in detecting E. coli. 

Proposed § 112.151(a)(1) provides for 

the use of official methods of analysis 

published by AOAC International in the 

latest edition of their publication 

‘‘Official Methods of Analysis of the 

Association of Official Analytical 

Chemists,’’ 18th edition, revision 4 

(published in 2011). The Official 

Methods of Analysis of AOAC 

International (18th Ed., revision 4, 2011) 

would be incorporated by reference 

with the approval of the Director of the 

Federal Register in accordance with 5 

U.S.C. 552(a) and 1 CFR Part 5. 

Proposed § 112.151(a)(2) would 

establish that methods of analysis 

published in the Standard Methods for 

the Examination of Water and 

Wastewater (21st Edition, 2005), 

American Public Health Association 

would be acceptable for testing the 

quality of water. In addition, the 

Standards Methods for the Examination 

of Water and Wastewater, (21st Ed., 

2005), would be incorporated by 

reference in accordance with 5 U.S.C. 

552(a) and 1 CFR part 5. 

Proposed § 112.151(a)(3) would 

establish that methods of analysis 

published in Chapter 4 of the FDA 

Bacteriological Analytical Manual 

(Edition 8, Revision A, 1998) (BAM), as 

updated in June 2011, would be 

acceptable for testing the quality of 

water. In addition, Chapter 4 of the 

BAM (Edition 8, Revision A, 1998), as 

updated in June 2011, would be 

incorporated by reference in accordance 

with 5 U.S.C. 552(a) and 1 CFR part 5. 

With advances in science and as 

appropriate, FDA periodically updates 

the BAM to add newer methods or 

revise existing ones. For the purposes of 

this proposed rule, we refer to Chapter 

4 of the BAM (edition 8, revision A, 

published in 1988) as updated in June 

2011. However, should FDA update or 

revise the methods and procedures 

currently listed in Chapter 4 of the June 

2011 version, for the purpose of testing 

the quality of water, we encourage 

industry to use such relevant, updated 

methods and procedures. 

Proposed § 112.151(a)(4) would 

provide for the use of a method that is 

at least equivalent in accuracy, 

precision, and sensitivity to the 

methods in § 112.151(a)(1), (a)(2) or 

(a)(3). Test kit methods are generally not 

published in the literature due to their 

proprietary nature. FDA is aware of 

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programs, such as the AOAC Research 

Institute’s Performance Tested Methods 

Program that provides an independent 

third-party review of proprietary test 

method performance. Test methods 

demonstrated to meet acceptable 

performance criteria are granted 

Performance Test Methods (PTM) status. 

The PTM certification assures users that 

an independent assessment has found 

that the test method performance meets 

an appropriate standard for the claimed 

use. FDA would consider methods, 

particularly test kit methods, approved 

by the PTM program or other similar 

programs acceptable for testing the 

quality of water. FDA is also aware that 

there are numerous scientific testing 

and diagnostic development companies 

that have invented rapid tests and 

systems for pathogens and water 

quality. Many of these products undergo 

rigorous internal quality control and 

performance testing, as well as receive 

additional third-party and/or regulatory 

approvals. FDA is also aware that the 

Environmental Protection Agency (EPA) 

approves analytical methods that 

industrial and municipal facilities use 

to determine pollutants of wastewater 

(published in 40 CFR Part 136) and to 

meet federal requirements or to 

demonstrate compliance with drinking 

water and ground water regulations (40 

CFR 141.402 and 40 CFR 141.403). For 

example, the EPA, has approved the use 

of E*Colite® Test, m-ColiBlue 24® Test, 

and Colitag® Test for compliance 

monitoring related to EPA’s Ground 

Water Rule. FDA would consider these 

tests acceptable for testing the quality of 

water to satisfy the requirements of 

§ 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 

incorporated by reference in accordance 

with 5 U.S.C. 552(a) and 1 CFR part 5. 

With advances in science and as 

appropriate, FDA periodically updates 

the BAM to add newer methods or 

revise existing ones. For the purposes of 

this proposed rule, we refer to Chapter 

10 of the BAM (Edition 8, revision A, 

published in 1998) as updated in April 

2011. However, should FDA update or 

revise the methods and procedures 

currently listed in Chapter 10 of the 

April 2011 version, for the purpose of 

testing the growing environment for 

Listeria spp. or L. monocytogenes, we 

encourage industry to use such relevant, 

updated methods and procedures. 

Proposed § 112.152 would also 

provide for the use of a method at least 

equivalent in accuracy, precision, and 

sensitivity in detecting Listeria spp. or 

L. monocytogenes as is the method 

described in Chapter 10 of the BAM. For 

example, prescribed rapid detection kits 

with their respective enrichment media 

may be conditionally used to screen for 

presence of Listeria contaminants. 

Isolates may be rapidly positively or 

negatively confirmed as L. 

monocytogenes by using specific test 

kits. FDA is aware that there are 

numerous scientific testing and 

diagnostic development companies that 

have invented rapid tests and systems 

for Listeria spp. or L. monocytogenes. 

Many of these products undergo 

rigorous internal quality control and 

performance testing, as well as receive 

additional third-party and/or regulatory 

approvals. As discussed above in 

proposed § 112.151(a)(4), FDA would 

consider methods, particularly test kit 

methods, approved for example by the 

AOAC Research Institute’s Performance 

Tested Methods Program PTM program 

or other similar, acceptable for testing 

Listeria spp. or L. monocytogenes. 

O. Subpart O—Requirements Applying 

to Records That You Must Establish and 

Keep 

As proposed, subpart O discusses the 

general requirements applicable to 

documentation and records that you 

must establish and maintain under 

proposed part 112. 

1. Comments Relevant to the Proposed 

Requirements 

We received several comments in 

response to the 2010 FR notice that 

addressed issues relevant to establishing 

and maintaining documents and 

records. Comments expressed concern 

over the costs of complying with record 

keeping requirements. Several 

comments also stated that there should 

not be a requirement for electronic 

record keeping for farmers, especially if 

they are small-scale. One comment 

requested that, to protect the 

confidentiality of individual farm 

businesses, any recordkeeping 

requirements be accompanied by 

assurance that information accessed by 

federal government authorities with 

respect to food safety protocols will 

remain confidential. Another comment 

requested that we consider pre-existing 

records kept by the produce industry for 

other purposes, so as to avoid 

duplication, while another farmer 

commented that records or documents 

would not ensure safety and, therefore, 

asked that records should be required 

for only annual activities, such as 

employee training and surveys of 

surrounding land activities. Finally, 

several comments indicated that the 

current legal liability system in the 

United States serves to discourage any 

grower or packing house from keeping 

additional detailed records related to 

food safety and that such records are 

subject to intrusive judicial subpoena 

power. 

We believe that documentation of 

some practices is critical to ensure that 

science-based minimum produce safety 

standards proposed in this rule are 

adequately implemented on the farm. 

Records are useful for keeping track of 

detailed information over a period of 

time. Records can identify patterns of 

problems and, thus, enable a farm to 

find and correct the source of problems. 

Records are also useful for investigators 

during inspections to determine 

compliance with requirements (e.g., by 

FDA investigators to determine 

compliance with requirements that 

would be established by this rule, or by 

a third party auditor that a farm or 

retailer may voluntarily engage under a 

business arrangement between the farm 

and the retailer). Therefore, we 

tentatively conclude that records of only 

annual activities are insufficient to 

ensure produce safety. However, in 

determining those circumstances in 

which records are necessary as part of 

science-based minimum standards that 

minimize the risk of serious adverse 

health consequences or death and 

provide reasonable assurances that 

produce is not adulterated under section 

402 of the FD&C Act, we considered the 

statutory direction in section 

419(c)(1)(C) of the FD&C Act to comply 

with the Paperwork Reduction Act (44 

U.S.C. 3501 et seq.) ‘‘with special 

attention to minimizing’’ the 

recordkeeping burden on the business 

and collection of information as defined 

in that act. We propose to require 

records in instances where maintenance 

of detailed information is needed to 

keep track of measures directed at 

minimizing the risk of known or 

reasonably foreseeable hazards, where 

identification of a pattern of problems is 

important to minimizing the risk of such 

hazards, or where they are important to 

facilitate verification and compliance 

with standards and this cannot be 

effectively done by means other than a 

review of records. See section IV.E of 

this document for further discussion. 

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Federal Register / Vol. 78, No. 11 / Wednesday, January 16, 2013 / Proposed Rules 3603 

We appreciate the concerns expressed 

by some commenters with respect to 

cost and burden to farms. To the extent 

possible, we attempted to propose 

documentation requirements that are 

risk-based and capable of being tailored 

to your individual farm, taking into 

account the unique characteristics of the 

operation, the commodities handled, 

and the operation’s growing, harvesting, 

packing, and holding procedures. A 

large majority of growers, farmers, and 

producers indicated during listening 

sessions and other stakeholder 

discussions that they already practice 

good agricultural practices and keep 

adequate records. They agreed that such 

recordkeeping is necessary. Moreover, 

they indicated that the cost of a large 

scale recall event would have the 

potential to far exceed the cost of 

routine record keeping. 

As proposed, the recordkeeping 

requirements allow the use of existing 

records and do not require duplication, 

provided such records satisfy all of the 

applicable requirements of this part (see 

proposed § 112.163). In addition, per 

proposed § 112.165, electronic records 

would be acceptable but would not be 

required by this subpart. Records would 

be acceptable under this subpart if kept 

in forms as diverse as hard copies of 

handwritten logs, invoices, and 

documents reporting laboratory results, 

provided that they are indelible and 

legible. 

We understand the concerns 

regarding confidentiality. Our 

disclosure of information is subject to 

the Freedom of Information Act (FOIA) 

(5 U.S.C. 552), the Trade Secrets Act (18 

U.S.C. 1905), the FD&C Act, and our 

implementing regulations under part 20, 

which include protection for 

confidential commercial information 

and trade secrets. We note that many 

segments of the food industry already 

are subject to food safety-related 

recordkeeping requirements similar to 

those proposed in this subpart. Other 

existing food safety regulations, such as 

the infant formula quality control 

procedures regulation (§ 106.100), the 

dietary supplement 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 similar record keeping. 

In addition, many farmers that are part 

of the various programs such as 

National Organic Program and LGMA 

already have similar recordkeeping 

requirements (Ref. 45. Ref. 261). 

Recordkeeping has proven useful for the 

above-mentioned food industries and, 

thus far, we are not aware that any of 

these industries has been adversely 

affected by excessive judicial subpoenas 

resulting from their recordkeeping. 

2. Proposed Requirements 

Proposed subpart O would establish 

requirements that would be applicable 

to all records required by part 112. FDA 

tentatively concludes that the 

requirements in subpart O describing 

how records must be established and 

maintained, including the general 

requirements, record retention 

requirements, and requirements for 

official review and public disclosure, 

are applicable to all records that would 

be required under all subparts, because 

records that would be required under 

each of the subparts would aid farms in 

complying with the requirements of part 

112; and allow farms to show, and FDA 

to determine, compliance with the 

requirements of part 112. 

a. General Requirements 

As proposed, § 112.161(a)(1) requires 

that your records include: (i) The name 

and location of your farm; (ii) actual 

values and observations obtained during 

monitoring; (iii) an adequate description 

(such as the commodity name, or the 

specific variety or brand name of a 

commodity, and, when available, any 

lot number or other identifier) of 

covered produce applicable to the 

record; (iv) the location of a growing 

area (for example, a specific field) or 

other area (for example, a specific 

packing shed) applicable to the record; 

and (v) the date and time of the activity 

documented. 

The name and location of your farm 

and the date and time would allow the 

owner, operator, or agent in charge of a 

farm (and, during inspection, an FDA 

investigator) to assess whether the 

record is current and establish the 

relevance of the record to your farm, 

which is necessary for review by 

regulators. An adequate description of 

covered produce would allow the farm 

to more readily track measures, identify 

a pattern of problems, and verify 

compliance. Such a description will 

also allow the farm to identify specific 

produce for which the standards of this 

part have not been met, and to take 

appropriate measures as provided for 

under § 112.11. 

Recording actual values and 

observations during monitoring are 

necessary to produce an accurate record. 

Notations that monitoring 

measurements are ‘‘satisfactory’’ or 

‘‘unsatisfactory,’’ without recording the 

actual times and observations (e.g., 

temperatures and turnings in treating 

biological soil amendments of animal 

origin) are vague and subject to varying 

interpretations and, thus, will not 

ensure that required measures have 

been taken or standards have been met. 

In addition, it is not possible to discern 

a trend without actual measurement 

values. 

Proposed § 112.161(a)(1) is consistent 

with our HACCP regulations for seafood 

and juice. Our HACCP regulations for 

seafood and juice require that all 

records include the name and location 

of the processor; the date and time of 

the activity that the record reflects; the 

signature or initials of the person 

performing the operation; and where 

appropriate, the identity of the product 

and the production code, if any 

(§§ 123.9(a) and 120.12(b), respectively). 

Our HACCP regulations for seafood and 

juice also require that records contain 

the actual values (such as temperature) 

and observations obtained during 

monitoring (§§ 123.6(c)(7) and 

120.12(b)(4), respectively). 

Additional requirements in proposed 

§ 112.161(a) include that records must 

be created at the time an activity is 

performed or observed (proposed 

§ 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 individual who 

made the observation would ensure 

responsibility and accountability. In 

addition, if there is a question about the 

record, a signature would ensure that 

the source of the record will be known. 

These proposed requirements are 

consistent with our HACCP regulations 

for seafood and juice. Our HACCP 

regulations for seafood and juice require 

that processing and other information be 

entered on records at the time that it is 

observed (§§ 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 must 

establish and keep documentation of 

actions you take when a standard in 

those subparts is not met. This 

documentation is necessary to show that 

you have taken the steps reasonably 

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necessary to minimize the risk of 

serious adverse health consequences or 

death from the use of, or exposure to, 

covered produce, including those 

measures reasonably necessary to 

prevent the introduction of known or 

reasonably foreseeable hazards into 

covered produce, and to provide 

reasonable assurances that the produce 

is not adulterated under section 402 of 

the FD&C Act. For example, if under 

§ 112.44(b) you are required to 

discontinue the use of agricultural water 

and take corrective steps, this provision 

would require you to establish and keep 

a record of the corrective steps that you 

took. 

As proposed, § 112.161(c) would 

require a supervisor or responsible party 

to review, date, and sign those records 

that are required under 112.50(b)(4), 

112.50(b)(5), 112.60(b)(1), 112.60(b)(3), 

112.140, 112.150(b)(1), 112.150(b)(4), 

and 112.161(b). These records relate to 

certain of your testing, monitoring, 

sanitizing, and corrective action 

activities. As described above, one of 

the primary purposes for establishing 

and maintaining records is so that you 

can review the records to see if the 

requirements of this part have been met. 

Requiring a signature from a supervisor 

or responsible party for these records 

emphasizes the importance of such a 

review. 

b. Storage of Records 

Proposed § 112.162 would establish 

the requirements regarding where your 

records must be stored. Proposed 

§ 112.162(a) establishes that offsite 

storage of records is permitted after 6 

months following the date the record 

was made if such record can be 

retrieved and provided onsite within 24 

hours of request for official review. FDA 

realizes that the proposed requirements 

for recordkeeping could require some 

farms to store a significant quantity of 

records, and that there may not be 

adequate storage space in the farm for 

these records. Providing for offsite 

storage of most records after 6 months 

would enable a farm to comply with the 

proposed requirements for record 

retention while reducing the amount of 

space needed for onsite storage of the 

records without interfering with the 

purpose of record retention, because the 

records will be readily available. 

Proposed § 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 the 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 following the date that the 

monitoring occurred, if such records can 

be retrieved and provided onsite within 

24 hours of request for official review 

and considers electronic records to be 

onsite if they are accessible from an 

onsite location (§ 120.12(d)(2)). We seek 

comment on the appropriateness of the 

proposed recordkeeping requirements. 

c. Use of Existing Records 

As proposed, § 112.163 would clarify 

that the regulations in this part do not 

require duplication of existing records if 

those records contain all of the 

information required by this part. In this 

provision, we seek to minimize the 

burden of keeping records to that which 

is necessary to accomplish the intended 

purposes of this part. 

For example, as proposed, you are not 

required to duplicate existing records, 

such as records kept to satisfy the 

requirements of the National Organic 

Program, if those records contain all of 

the information required by this part. 

Additionally, you are not required to 

keep all of the information required by 

this part in one set of records. Similarly, 

if you have records containing some but 

not all of the required information, this 

proposed regulation provides you the 

flexibility to keep any additional 

information required by this part either 

separately or combined with your 

existing records. While we propose this 

provision to give you the greatest degree 

of flexibility, we remind you that 

keeping records together in one place 

likely will expedite review of records in 

the event of a public health emergency 

or during an FDA inspection or 

investigation. 

d. Length of Time for Records Storage 

Proposed § 112.164(a) would require 

that you keep records required by this 

part for two years after the date the 

record was created. Retaining records 

for at least this length of time is 

necessary to ensure that the records are 

available for reference during 

verification activities as well as during 

FDA inspections. It is also critical for 

documentation and observation of 

trends of the food safety risks that may 

affect your operation over time. Multiyear retention of records allows an 

owner, operator, or agency to better 

understand and proactively respond to 

the risk factors affecting his or her farm. 

Since many weather events, such as 

drought or floods, which have an 

influence on the safety of fresh produce 

are relatively rare; maintaining 

historical records to inform the 

development of preventive controls 

specific to a given operation is 

invaluable. Similarly, proposed 

§ 112.164(b) would establish that 

records that relate to the general 

adequacy of the equipment or processes 

being used by a farm, including the 

results of scientific studies and 

evaluations, must be retained at the 

farm for at least two years after the use 

of such equipment or processes is 

discontinued. 

Certain growers and packers of 

covered produce currently retain 

records for at least two years. For 

example, produce operations certified 

by the National Organic Program must 

maintain their records relating to the 

production, harvesting, and handling of 

‘‘organic’’ agricultural products for at 

least five years beyond the creation of 

the records (7 CFR 205.103). USDA’s 

Agricultural Marketing Service requires 

that restricted use pesticide records be 

maintained for two years from the date 

of pesticide application (7 CFR 110.3). 

Under USDA’s regulations 

implementing the Perishable 

Agricultural Commodities Act, 1930 

(PACA), packers who pack and sell 

another firm’s produce and growers and 

packers who voluntarily obtain a PACA 

license are required to preserve records 

for two years (7 CFR 46.14). Under the 

Florida Tomato Rule (‘‘Tomato Good 

Agricultural Practices [T–GAP] & 

Tomato Best Management Practices’’) 

(Ref. 262), firms must keep records 

documenting adherence to T–GAPs, 

‘‘including those addressing 

environmental review, water usage, 

record of completed education and 

training, pest control and crop 

production practices for the operation,’’ 

for at least three calendar years (Ref. 44). 

Participants in the California Leafy 

Green Marketing Agreement (LGMA) 

must maintain their records kept under 

the LGMA agreement for two years (Ref. 

45). 

e. Acceptable Formats for Records 

As proposed, § 112.165 would require 

that you keep records as either: (a) 

Original records; (b) true copies (such as 

photocopies, pictures, scanned copies, 

microfilm, microfiche, or other accurate 

reproductions of the original records); or 

(c) electronic records in compliance 

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with part 11. True copies of records 

should be of sufficient quality to detect 

whether the original record was 

changed or corrected in a manner that 

obscured the original entry (e.g., 

through the use of white-out). Proposed 

§ 112.165 would provide flexibility for 

mechanisms for keeping records while 

maintaining the integrity of the 

recordkeeping system. The proposed 

requirement allowing true copies is 

consistent with other regulations such 

as our Good Manufacturing Practices 

(GMPs) regulation for dietary 

supplements (§ 111.605(b)) and provides 

options that may be compatible with the 

way records 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 provides criteria for 

acceptance by FDA, under certain 

circumstances, of electronic records, 

electronic signatures, and handwritten 

signatures executed to electronic 

records as equivalent to paper records 

and handwritten signatures executed on 

paper. The proposed requirement 

clarifies and acknowledges that records 

required by part 112 may be retained 

electronically, provided that they 

comply with part 11. 

FDA tentatively concludes that it is 

appropriate to apply the requirements of 

part 11 to the records that would be 

required to be kept under part 112. 

However, we request comment on 

whether there are any circumstances 

that would warrant not applying part 11 

to records that would be kept under part 

112. For example, would a requirement 

that electronic records be kept according 

to part 11 mean that current electronic 

records and recordkeeping systems 

would have to be recreated and 

redesigned, which we determined to be 

the case in the regulation Establishment 

and Maintenance of Records Under the 

Public Health Security and Bioterrorism 

Preparedness and Response Act of 2002 

(69 FR 71562; December 9, 2004 (the BT 

records regulation))? For the purposes of 

the records requirements in the BT 

records regulation, we concluded that it 

was not necessary for new 

recordkeeping systems to be established 

as long as current practices would 

satisfy the requirements of the Act and, 

therefore, we exempted the records from 

the requirements of part 11 (21 CFR 

1.329(b)). We also exempted records 

related to certain cattle materials 

prohibited from use in human food and 

cosmetics from part 11 (21 CFR 

189.5(c)(7) and 700.27(c)(7), 

respectively). We also seek comment on 

whether we should allow additional 

time for electronic records to be kept in 

accordance with part 11. Comments 

should provide the basis for any view 

that the requirements of part 11 are not 

warranted. 

f. Making Records Available for Official 

Review 

Proposed § 112.166(a) would require 

that you have all records required under 

this part readily available and accessible 

during the retention period for 

inspection and copying by FDA upon 

oral or written request, except that you 

have 24 hours to obtain records you 

keep offsite and make them available 

and accessible to FDA for inspection 

and copying. Our access to records 

required under this part would expedite 

efforts to document and ensure that 

covered produce is not adulterated, as 

well as to quickly and accurately 

identify any adulterated covered 

produce and prevent it from reaching 

consumers. For example, during a 

foodborne illness outbreak or 

contamination investigation, records 

access would help enable you and us to 

pinpoint the source and cause of 

contamination in a timely manner. This 

provision is consistent with our HACCP 

regulations for juice (§ 120.12(e)) and 

seafood (§ 123.9(c)), and dietary 

supplement GMPs (§ 111.610(b)), which 

require that all records required under 

those rulemakings be available for 

review and copying at reasonable times. 

This provision also is similar to 

requirements in the infant formula 

quality control procedures regulation 

(§ 106.100(l)) stating that manufacturers 

make readily available for authorized 

inspection all records required under 

those regulations. In addition, this 

proposed provision is similar to 

provisions in the juice HACCP 

regulation (§ 123.9(f)) and in the 

regulation on production, storage, and 

transportation of shell eggs (§ 118.10(d)) 

that require that firms be able to retrieve 

and provide any records stored offsite 

within 24 hours of request for official 

review. 

Proposed § 112.166(b) would require 

that if you use electronic techniques to 

keep records, or to keep true copies of 

records, or if you use reduction 

techniques such as microfilm to keep 

true copies of records, that you provide 

the records to us in a format in which 

they are accessible and legible. For 

example, you might provide us with an 

unencrypted copy of an electronic 

record or provide us with suitable 

equipment for viewing, printing, and 

copying a record. This provision would 

enable us to comprehend your records 

in a timely manner. 

Consistent with proposed 

§ 112.166(a), proposed § 112.166(c) 

would require that if your farm is closed 

for a prolonged period, the records may 

be transferred to some other reasonably 

accessible location but must be returned 

to your farm within 24 hours for official 

review upon request. Allowing for 

transfer of records will give practical 

storage relief to seasonal operations or 

those closed for other reasons for 

prolonged periods. Proposed 

§ 112.166(c) is consistent with our 

HACCP regulations for seafood and 

juice, which provide for transfer of 

records for facilities closed for 

prolonged periods (between seasonal 

packs, in the case of juice) if the records 

could be immediately returned for 

official review upon request 

(§§ 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 are 

subject to the disclosure requirements 

under part 20 of this chapter. FDA’s 

regulations in 21 CFR part 20, FOIA, the 

Trade Secrets Act [18 U.S.C. 1905], and 

the FD&C Act govern FDA’s disclosures 

of information, including treatment of 

confidential commercial information 

and trade secret information. Our 

general policies, procedures, and 

practices relating to the protection of 

confidential information received from 

third parties would apply to information 

received under this rule. Proposed 

§ 112.167 is consistent with, but framed 

differently than, the disclosure 

provisions of the HACCP regulations for 

seafood and juice (§§ 123.9(d) and 

120.12(f), respectively). Proposed 

§ 112.167 is framed similarly to the 

disclosure provisions for records that 

must be kept under part 118 (Prevention 

of Salmonella Enteritidis in Shell Eggs 

During Production); under § 118.10(f), 

records required by part 118 are subject 

to the disclosure requirements under 

part 20. 

P. Subpart P—Variances 

1. Relevant Provisions of Section 419 of 

the FD&C Act 

In section 419(c), the FD&C Act 

establishes criteria for the final 

regulation, including that the final 

regulation ‘‘permit States and foreign 

countries from which food is imported 

into the United States to request from 

the Secretary variances from the 

requirements of the regulations, subject 

to [section 419(c)(2) of the FD&C Act], 

where the State or foreign country 

determines that the variance is 

necessary in light of local growing 

conditions and that the procedures, 

processes, and practices to be followed 

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under the variance are reasonably likely 

to ensure that the produce is not 

adulterated under section 402 [of the 

FD&C Act] and to provide the same 

level of public health protection as the 

requirements of the regulations adopted 

under [section 419(b) of the FD&C Act]’’ 

(section 419(c)(1)(F)). Section 419(c)(2) 

specifies the following: 

‘‘REQUESTS FOR VARIANCES.—A 

State or foreign country from which 

food is imported into the United States 

may in writing request a variance from 

the Secretary. Such request shall 

describe the variance requested and 

present information demonstrating that 

the variance does not increase the 

likelihood that the food for which the 

variance is requested will be adulterated 

under section 402, and that the variance 

provides the same level of public health 

protection as the requirements of the 

regulations adopted under [section 

419(b) of the FD&C Act]. The Secretary 

shall review such requests in a 

reasonable timeframe’’ (section 

419(c)(2)(A)). 

‘‘APPROVAL OF VARIANCES.—The 

Secretary may approve a variance in 

whole or in part, as appropriate, and 

may specify the scope of applicability of 

a variance to other similarly situated 

persons’’ (section 419(c)(2)(B)). 

‘‘DENIAL OF VARIANCES.—The 

Secretary may deny a variance request 

if the Secretary determines that such 

variance is not reasonably likely to 

ensure that the food is not adulterated 

under section 402 and is not reasonably 

likely to provide the same level of 

public health protection as the 

requirements of the regulation adopted 

under [section 419(b) of the FD&C Act]. 

The Secretary shall notify the person 

requesting such variance of the reasons 

for the denial’’ (section 419(c)(2)(C)). 

‘‘MODIFICATION OR REVOCATION 

OF A VARIANCE.—The Secretary, after 

notice and an opportunity for a hearing, 

may modify or revoke a variance if the 

Secretary determines that such variance 

is not reasonably likely to ensure that 

the food is not adulterated under section 

402 and is not reasonably likely to 

provide the same level of public health 

protection as the requirements of the 

regulations adopted under [section 

419(b) of the FD&C Act]’’ (section 

419(c)(2)(D)). 

2. Proposed Requirements 

Consistent with the statutory 

provisions mentioned above, in this 

subpart, we propose a process by which 

variances from one or more 

requirements of part 112 may be 

requested by a State or foreign 

government, information that must 

accompany such requests, and the 

procedures and circumstances under 

which FDA may grant or deny such 

requests, and modify or revoke such 

variances. Variances approved by FDA 

would be limited to the requirements of 

part 112 specified by FDA, and have no 

effect on the application of other 

provisions of the FD&C Act. 

Consistent with section 419(c)(2)(A) 

of the Act, proposed § 112.171 would 

establish that a State or foreign country 

from which food is imported into the 

U.S. may request a variance from one or 

more of the requirements proposed in 

part 112, where the State or foreign 

country determines that the variance is 

necessary in light of local growing 

conditions (proposed § 112.171(a)); and 

the procedures, processes, and practices 

to be followed under the variance are 

reasonably likely to ensure that the 

produce is not adulterated under 

Section 402 of the Act and to provide 

the same level of public health 

protection as the requirements of 

proposed part 112 (proposed 

§ 112.171(b)). Such a determination 

would likely be based on the particular 

crop, climate, soil, geographic, and 

environmental conditions of a particular 

region, as well as processes, procedures, 

or practices followed in that region. 

Given the diversity of covered produce 

commodities and covered activities 

subject to the requirements of part 112, 

we tentatively conclude that this 

provision provides sufficient flexibility 

while ensuring the same level of public 

health protection for covered produce. 

For example, a State or foreign country 

may consider that the historical 

performance of an industry within their 

jurisdiction (e.g., as indicated by the 

epidemiological record) and the 

combination of measures taken by that 

industry merits requesting a variance 

from some or all provisions of this 

proposed rule. In requesting a variance, 

among other things, the State or foreign 

country would submit information that, 

while the procedures, processes and 

practices to be followed under the 

variance would be different from those 

prescribed in this proposed rule, the 

requested variance is reasonably likely 

to ensure that the produce is not 

adulterated under section 402 of the 

FD&C Act and provide the same level of 

public health protection as the 

requirements of the final regulations 

(see proposed 112.173). FDA would 

encourage consideration of these kinds 

of submissions, and welcomes requests 

for pre-petition consultations, including 

meetings, with interested States or 

foreign governments to facilitate the 

development of variance petitions, 

including data and information that 

would be needed to demonstrate that 

the variance is necessary in light of local 

growing conditions and that the 

procedures, processes, and practices to 

be followed under the variance are 

reasonably likely to ensure that the 

produce is not adulterated under 

Section 402 of the Act and provide the 

same level of public health protection as 

the requirements in this rule, when 

finalized. As discussed in section IV.K, 

FDA is proposing extended compliance 

dates for this proposed rule. We expect 

that these compliance periods would 

allow sufficient time for variance 

petitions to be developed, submitted, 

and reviewed by FDA. We request 

comment on the compliance periods. 

In proposed § 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 addition to the requirements set 

forth in § 10.30, the Statement of 

Grounds (which is specified under 

§ 10.30(b)) such petition requesting a 

variance must include a statement that 

the applicable State or foreign country 

has determined that the variance is 

necessary in light of local growing 

conditions and that the procedures, 

processes, and practices to be followed 

under the variance are reasonably likely 

to ensure that the produce is not 

adulterated under Section 402 of the Act 

and to provide the same level of public 

health protection as the requirements of 

this part (proposed § 112.173(a)). In 

addition, the Statement of Grounds 

would be required to describe with 

particularity the variance requested, 

including the persons to whom the 

variance would apply and the 

provision(s) of part 112 to which the 

variance would apply (proposed 

§ 112.173(b)); and present information 

demonstrating that the procedures, 

processes, and practices to be followed 

under the variance requested are 

reasonably likely to ensure that the 

produce is not adulterated under 

Section 402 of the Act and to provide 

the same level of public health 

protection as the requirements of 

proposed part 112 (proposed 

§ 112.173(c)). Under these provisions, a 

State or foreign country would be 

required to submit relevant and 

scientifically-valid information or 

materials specific to the covered 

produce or covered activity to support 

the petitioner’s determination that the 

variance requested is reasonably likely 

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to ensure that the produce is not 

adulterated under Section 402 of the Act 

and to provide the same level of public 

health protection as the requirements of 

this part. This would include 

information about the crop, climate, 

soil, and geographical or environmental 

conditions of a particular region, as well 

as the processes, procedures, or 

practices followed in that region. 

Proposed § 112.174 establishes our 

presumption that information submitted 

in a petition requesting a variance and 

comments submitted on such a petition, 

including a request that a variance be 

applied to its similarly situated persons, 

does not contain information exempt 

from public disclosure under part 20 of 

this chapter and would be made public 

as part of the docket associated with this 

request. We do not believe that 

information exempt from disclosure 

under part 20 of this chapter is the type 

of information that FDA is requiring to 

be submitted in such a petition or that 

would be relevant in any comments 

submitted on such a petition. We also 

believe that providing full public access 

to this information is important to 

ensuring transparency and for the 

opportunity for states and foreign 

governments to request similar 

variances for similarly situated persons. 

Therefore, we expect to make these 

submissions publicly available. 

Proposed § 112.175 would establish 

the Director or Deputy Directors of the 

Center for Food Safety and Applied 

Nutrition (CFSAN), or the Director of 

the Office of Compliance, CFSAN as the 

responsible official for responding to a 

request for a variance from one or more 

requirements in proposed part 112. 

Proposed § 112.176 would establish 

the general procedures applying to a 

petition requesting a variance from one 

or more requirements 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 requesting a 

variance. Section 10.30 of this chapter 

specifies the requirements for any 

citizen petition submitted by a person 

(including a petitioner who is not a 

citizen of the United States) to FDA. 

Proposed § 112.176(b) would establish 

that, under § 10.30(h)(3) of this chapter, 

we will publish a notice in the Federal 

Register, requesting information and 

views on the filed petition, including 

information and views from persons 

who could be affected by the variance 

if the petition were to be granted (either 

because their farm is covered by the 

petition or as a person similarly situated 

to persons covered by the petition). For 

example, similarly situated persons may 

include those whose farm operates 

under similar circumstances with 

similar procedures, processes, and 

practices as those covered by the 

petition. Proposed § 112.176(c) would 

establish that, under § 10.30(e)(3), FDA 

will respond to the petitioner in writing 

and will publish a notice on our Web 

site announcing our decision to either 

grant or deny the petition. Proposed 

§ 112.176(c)(1) would establish that, if 

we grant the petition, either in whole or 

in part, we will specify the persons to 

whom the variance would apply and the 

provision(s) of this part to which the 

variance would apply. Proposed 

§ 112.176(c)(2) would establish that, if 

FDA denies the petition (including 

partial denials), FDA will explain the 

reason(s) for the denial in its written 

response to the petitioner and in the 

notice on our Web site announcing the 

decision to deny. Under proposed 

§ 112.176(d), we propose to make 

readily accessible to the public, and 

periodically update, a list of filed 

petitions requesting variances, 

including the status of each petition (for 

example, pending, granted, or denied). 

The provisions in proposed § 112.176 

would ensure transparency in FDA’s 

activities and decision-making, which 

allows the public to better understand 

the agency’s decisions, increasing 

credibility and promoting 

accountability. 

Proposed § 112.177 would establish 

circumstances under which an 

approved variance could apply to any 

person other than those identified in the 

petition requesting the variance. Under 

proposed § 112.177(a), a State or a 

foreign country that believes that a 

variance requested by a petition 

submitted by another State or foreign 

country should also apply to similarly 

situated persons in its jurisdiction may 

request that the variance be applied to 

its similarly situated persons by 

submitting comments in accordance 

with § 10.30. These comments must 

include the information required in 

§ 112.173. If FDA determines that these 

comments should instead be treated as 

a separate request for a variance, FDA 

will notify the State 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 those identified in the 

petition. Consequently, under proposed 

§ 112.177(c), if we specify that the 

variance also applies to persons in a 

specific location who are similarly 

situated to those identified in the 

petition, we will inform the applicable 

State or foreign country where the 

similarly situated persons are located of 

our decision in writing and will publish 

a notice on our Web site announcing our 

decision to apply the variance to 

similarly situated persons in that 

particular location. We tentatively 

conclude that the provisions in 

proposed § 112.177 ensure 

consideration of the application of 

variances to similarly situated persons 

to and provide for transparency and 

accountability in FDA’s review of 

requests and decision-making. 

Proposed § 112.178 would provide 

that we may deny a variance request if 

it does not provide the information 

required under proposed § 112.173 

(including the requirements of § 10.30), 

or if we determine that the variance is 

not reasonably likely to ensure that the 

produce is not adulterated under 

Section 402 of the Act and to provide 

the same level of public health 

protection as the requirements of this 

part. For example, we would expect to 

deny a petition if the State or foreign 

government failed to submit 

scientifically-valid data, information, or 

materials to demonstrate that the 

procedures, processes, or practices to be 

followed under the requested variance 

are reasonably likely to ensure that the 

produce is not adulterated under 

Section 402 of the Act and to provide 

the same level of public health 

protection as the requirements of 

proposed part 112. 

Proposed § 112.179 would specify 

that a variance 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 

variance is not reasonably likely to 

ensure that the produce is not 

adulterated under Section 402 of the Act 

and to provide the same level of public 

health protection as the requirements of 

proposed part 112. For example, we 

may deem it necessary to modify terms 

and conditions of the variance based on 

a review of updated scientific data or 

factual information that is applicable to 

the covered produce and procedures, 

processes, or practices followed under 

the variance. 

Proposed § 112.181 would establish 

the procedures that apply if FDA 

determines that an approved variance 

should be modified or revoked. Under 

§ 112.181(a), we would provide notice 

of such a determination as follows: (1) 

We will notify a State or a foreign 

country directly, in writing at the 

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address identified in its petition, if we 

determine that a variance granted in 

response to its petition should be 

modified or revoked. Our direct, written 

notification will provide the State or 

foreign country with an opportunity to 

request an informal hearing under part 

16 of this chapter; (2) We will publish 

in the Federal Register a notice of our 

determination that a variance should be 

modified or revoked. This notice will 

establish a public docket so that 

interested parties may submit written 

submissions on our determination; and 

(3) When applicable, we will: (i) Notify 

in writing any States or foreign 

countries where a variance applies to 

similarly situated persons of our 

determination that the variance should 

be modified or revoked; (ii) Provide 

those States or foreign countries with an 

opportunity to request an informal 

hearing under part 16 of this chapter; 

and (iii) Include in the Federal Register 

notice described in paragraph (a)(2) of 

this section public notification of our 

decision to modify or revoke the 

variance granted to States or foreign 

countries in which similarly situated 

persons are located. 

Under § 112.181(b), we would 

consider submissions from affected 

States or foreign countries and from 

other interested parties as follows: (1) 

We will consider requests for hearings 

by affected States or foreign countries 

under part 16 of this chapter. If FDA 

grants a hearing, we will provide the 

State or foreign country with an 

opportunity to make an oral submission. 

We will provide notice on our Web site 

of the hearing, including the time, date, 

and place of hearing. If more than one 

State or foreign country requests an 

informal hearing under part 16 of this 

chapter about our determination that a 

particular variance should be modified 

or revoked, we may consolidate such 

requests (for example, into a single 

hearing); and (2) We will consider 

written submissions submitted to the 

public docket from interested parties. 

Under § 112.181(c), we would provide 

notice of our final decision as follows: 

(1) On the basis of the administrative 

record, FDA will issue a written 

decision, as provided for under part 16 

of this chapter; and (2) We will publish 

a notice of our decision in the Federal 

Register. The effective date of the 

decision will be the date of publication 

of the notice. 

We tentatively conclude that these 

provisions are necessary not only to 

ensure transparency and accountability 

in FDA’s activities and decision-making, 

but also to provide relevant parties with 

an opportunity for due process. 

Finally, in proposed § 112.182, we 

would provide examples of permissible 

types of variances. These examples of 

variances from certain requirements in 

proposed part 112 are consistent with 

our proposed provisions in subpart B for 

alternatives from requirements in 

proposed part 112. A State or foreign 

government may request a variance from 

other requirements in proposed part 

112, provided the conditions described 

in proposed § 112.171 are met. 

3. Conforming Amendment to 21 CFR 

Part 16 

We propose to amend § 16.1(b)(1) to 

include Section 419(c)(2)(D) of the 

FD&C Act relating to the modification or 

revocation of a variance from the 

requirements of Section 419 of the 

FD&C Act, to the list of statutory and 

regulatory provisions under which 

regulatory hearings are available. 

Q. Subpart Q—Compliance and 

Enforcement 

1. Overall Strategy for Implementation 

and Compliance 

FDA expects this proposed rule to 

improve produce safety to the extent the 

proposed requirements related to 

practices are actually implemented by 

farms. Many farms already follow some 

or all of the proposed practices, but we 

recognize that, when finalized, the 

proposed rule will be the first national 

standard for on-farm practices related to 

produce safety and that it will take time 

and a concerted, community-wide effort 

for the wide range of farms to come into 

full compliance. FDA is committed to 

working with the produce community 

and with partners in the U.S. 

Department of Agriculture, State 

agencies, and foreign governments to 

facilitate compliance through education, 

technical assistance and regulatory 

guidance. 

We anticipate that compliance will be 

achieved primarily through the 

conscientious efforts of farmers, 

complemented by the efforts of State 

and local governments, extension 

services, private audits and 

certifications, and other private sector 

supply chain management efforts. We 

also recognize that the time needed to 

comply will vary, so we are proposing 

to phase in compliance dates based on 

farm size (see section IV.K of this 

document). 

Under the FD&C Act, FDA has 

authority to inspect produce farms and 

can take enforcement action when 

needed to prevent significant hazards 

from entering the food supply or in 

response to produce safety problems, 

although FDA faces severe constraints 

in inspection and enforcement when it 

comes to foreign farms. FDA’s 

inspection resources are very limited, 

however, in relation to the number of 

produce farms and the many other food 

production, processing and storage 

settings for which FDA has regulatory 

responsibility. Thus, as outlined below, 

FDA inspection will play an important 

but necessarily limited role in the 

overall compliance effort. FDA invites 

comment on all aspects of its 

compliance strategy. 

2. Education, Technical Assistance and 

Regulatory Guidance 

Education and technical assistance is 

the foundation of our intended 

compliance strategy. As discussed in 

section II.D. above, FDA has, together 

with USDA AMS, established a jointlyfunded Produce Safety Alliance (PSA), 

a public-private partnership that will 

develop and disseminate science- and 

risk-based training and education 

programs to provide produce growers 

and packers with fundamental food 

safety knowledge. A first phase of PSA’s 

work is intended to assist farms, 

especially small and very small farms, 

in establishing food safety programs 

consistent with the GAPs Guide and 

other existing guidances so that they 

will be better positioned to comply 

when we issue a final produce safety 

rule under section 419 of the FD&C Act. 

As this rulemaking progresses, FDA will 

work to ensure that the PSA materials 

are modified, as needed, to be consistent 

with the requirements of the produce 

safety rule. FDA intends to work with 

federal, State, and local officials, 

industry, and academia through the PSA 

to assist farmers to implement measures 

necessary to minimize the risk of 

serious adverse health consequences or 

death from consumption of covered 

produce. 

We also will work to provide 

education and technical assistance 

through other sources of information 

that are familiar to the produce farming 

community (such as Cooperative 

Extension, land grant universities, trade 

associations, and foreign partners and 

JIFSAN to reach farmers exporting 

covered produce into the U.S. in their 

local languages). We plan to work with 

these and other stakeholders to develop 

a network of institutions that can 

provide technical assistance to the 

farming community, especially small 

and very small farms, as they endeavor 

to comply with the provisions of the 

final rule. 

FDA intends to further facilitate 

compliance with a final produce safety 

rule through the development and 

dissemination of guidance, in multiple 

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languages, on procedures, conditions, 

and practices that farms can implement 

to reduce the risk of known or 

reasonably foreseeable hazards. Section 

419(e) of the FD&C Act requires FDA to 

develop guidance ‘‘for the safe 

production and harvesting of specific 

types of fresh produce under [section 

419]’’ and to hold at least three public 

meetings in diverse geographical areas 

of the U.S. as part of an effort to conduct 

education and outreach regarding the 

guidance. Consistent with this statutory 

provision, FDA plans to develop 

guidance materials, including additional 

guidances specific to commodities, 

practices, and conditions, as needed and 

informed, in part, by stakeholder input, 

including that received during public 

meetings. 

Section 419(a)(4) of FSMA states that 

‘‘the Secretary shall prioritize the 

implementation of the regulations under 

this section for specific fruits and 

vegetables that are raw agricultural 

commodities based on known risks 

which may include a history and 

severity of foodborne illness outbreaks.’’ 

As discussed immediately above, we 

intend to fulfill this mandate by (1) 

conducting extensive outreach and 

educational efforts focused on the 

known risks of specific types of produce 

and specific types of agricultural 

practices applied to such produce; (2) 

focusing our inspection and 

enforcement efforts on farms that 

present the greatest risk based, in part, 

on past association with outbreaks, 

contamination, or the known risks of 

their agricultural practices and 

conditions and/or their specific types of 

produce; and (3) developing guidance 

materials related to the rule (including 

commodity-specific guidances) focused 

on known risks. We request comment 

on this approach and on specific 

strategies we should employ in order to 

best prioritize our implementation of 

the rule in this manner. 

3. Supply Chain Management 

FDA anticipates that significant 

incentives and accountability for 

compliance with a final produce safety 

rule will come through non-regulatory 

audits and supply chain management 

initiated by private entities. 

As discussed in section II.F.2. of this 

document, a number of retail produce 

buyers currently require, as a condition 

of sale, that their produce suppliers 

comply with and be audited by third 

parties for conformance with the FDA 

GAPs guide. USDA AMS also offers a 

GAPs and Good Handling Practices 

(GAP&GHP) Audit Verification Program. 

USDA AMS and the California 

Department of Food and Agriculture 

(CDFA) have developed and are 

implementing the California Leafy 

Greens Marketing Agreement (CA 

LGMA) to protect public health via 

compliance with the food safety 

practices that are accepted by the LGMA 

board (Ref. 45). Compliance with such 

practices is further verified for members 

and signatories to the agreement 

through mandatory government audits 

by CDFA auditors who are trained and 

licensed by USDA AMS (Ref. 263). 

Leafy greens growers in Arizona have 

adopted a similar marketing agreement 

and audit structure for their growers 

(Ref. 32). 

At the request of industry, the USDA 

AMS in 2009 held seven hearings 

throughout the United States to solicit 

input from the leafy greens industries 

across the U.S. regarding their desire to 

develop a proposed national marketing 

agreement for leafy greens. A decision 

regarding the proposed USDA AMS 

national marketing agreement for leafy 

greens is currently pending, but FDA 

and USDA are committed to working 

together to harmonize the provisions of 

any national or regional marketing 

agreements for produce with the 

provisions of any final rule FDA issues 

under section 419 of the FD&C Act. 

Rigorous audits conducted under 

national or regional marketing 

agreements can be an important tool for 

fostering compliance with the produce 

safety rule. 

FDA also intends to issue notices of 

proposed rulemaking implementing 

sections 418 and 805 of the FD&C Act 

(sections 103 and 301 of FSMA). FDA is 

aware of the diversity in quality of 

audits and the need to strengthen that 

system, but we anticipate that audits 

will be an important source of 

accountability for compliance with a 

final produce safety rule. 

4. Inspections 

With a community as large and 

diverse as the produce farming industry, 

it is not reasonable to expect that 

industry-wide compliance can be gained 

primarily through inspection and 

enforcement, though, of course, 

inspection and enforcement must be a 

component of our efforts. Inspections 

will, of necessity, be targeted to those 

farms that present the greatest risk 

based, in part, on their association with 

past outbreaks or contamination events 

and the risk associated with the 

agricultural practices they apply in the 

growing, harvesting, packing, and 

holding of covered produce. 

FDA intends to work collaboratively 

with our federal and State regulatory 

partners to use available inspection 

resources to conduct risk-based 

inspections of farms for compliance 

with a final produce safety regulation. 

Section 702(a)(1)(A) of the FD&C Act [21 

U.S.C. 372(a)(1)(A)] expressly authorizes 

FDA to conduct examinations and 

investigations for the purposes of the 

FD&C Act through any health, food, or 

drug officer or employee of any State, 

Territory, or political subdivision 

thereof (such as a locality), duly 

commissioned to act on behalf of FDA. 

Qualified State, Territorial, or local 

regulatory officials may be 

commissioned or serve under contract 

with FDA to conduct examinations, 

inspections, and investigations for 

purposes of the FD&C Act. In addition, 

section 702(a)(2) [21 U.S.C. 372(a)(2)] 

expressly authorizes FDA to conduct 

examinations and investigations for the 

purposes of the FD&C Act through 

officers and employees of another 

Federal department or agency, subject to 

certain conditions set forth in that 

section. We expect to continue to 

cooperatively leverage the resources of 

federal, State, and local government 

agencies in this way as we strive to 

obtain industry-wide compliance with a 

final produce safety rule. 

Section 419(b)(2)(A) of the FD&C Act 

specifically instructs FDA to ‘‘provide 

for coordination of education and 

enforcement activities by State and local 

officials, as designated by the Governors 

of the respective States or the 

appropriate elected State official as 

recognized by State statute.’’ Consistent 

with this provision and with the 

direction to improve the training of 

State, local, territorial, and tribal food 

safety officials under Section 1011 of 

the FD&C Act (21 U.S.C. 399c, added to 

the FD&C Act by section 209 of FSMA), 

FDA intends to work closely with 

extension and education organizations 

and State, local, territorial, and tribal 

partners to develop the tools and 

training programs needed to facilitate 

consistent inspection and regulatory 

activities associated with the 

requirements of a final produce safety 

rule. We expect to build on our 

collaboration with State, local, 

territorial, and tribal officials in the 

development of tools and training for 

use by inspectors in farm investigations 

on issues specific to food safety during 

growing, harvest, packing and holding 

produce. 

FDA anticipates that some States may 

choose to adopt requirements modeled 

after the provisions of a final federal 

produce safety rule and may choose to 

perform inspections under their own 

authorities to enforce those provisions 

of their state laws. Such actions would 

further drive compliance with a final 

federal produce safety rule. 

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5. Comments Related to the Proposed 

Provisions 

We received many comments on 

strategies for compliance, including 

comments from farmers, consumers, 

retail, State, federal and foreign 

governments, academia, trade 

associations and industry groups, and a 

non-profit research and advocacy 

organization. These comments broadly 

expressed strategies for compliance that 

included specific suggestions on how to 

ensure that all covered produce is in 

compliance with a final rule. Several 

comments recognized the importance of 

partnerships with respect to bringing 

about compliance with, and ultimately 

enforcing, a final rule. Comments urged 

the agency to work in cooperation with 

other federal, State, Territorial, tribal 

and local agencies with jurisdiction and 

expertise to ensure a coordinated and 

uniform approach to enforcement and 

compliance that will improve efficiency 

and effectiveness. Several comments 

noted that governmental testing 

laboratories should be recognized and 

funding should be provided to States to 

hire and train auditors. 

We agree that partnerships will play 

a crucial role in bringing the produce 

industry into compliance with a final 

rule. As discussed in our overall 

strategy above and reflected in proposed 

112.193, FDA intends to work with 

State, Territorial, tribal, and local 

partners to develop the education and 

enforcement tools and training programs 

needed to facilitate consistent 

inspection and regulatory activities 

associated with the requirements of a 

final produce safety rule. Education and 

outreach through mechanisms like PSA 

and other sources of information that 

are familiar to the produce farming 

community (such as Cooperative 

Extension, land grant universities, and 

trade associations) are the foundation of 

our intended compliance strategy. We 

also plan to work with these and other 

stakeholders to develop a network of 

institutions that can provide technical 

assistance to the farming community, 

especially small and very small farms, 

as they endeavor to comply with the 

provisions of a final rule. Of course, 

although much of our initial effort will 

be focused on education and outreach, 

we will also inspect farms on a targeted 

basis for compliance with a final 

produce safety rule. Partnerships will 

play an important role with regard to 

inspections as well. FDA intends to 

work collaboratively with our federal, 

State, Territorial, tribal, and local 

regulatory partners to use available 

inspection resources to conduct riskbased inspections of farms for 

compliance with the final regulation. 

FDA intends to further facilitate 

compliance with our final regulation 

through the development and 

dissemination of guidance on 

procedures, conditions, and practices 

that farms can implement to reduce the 

risk of known or reasonably foreseeable 

hazards. 

Several comments noted that foreign 

governments could also play an 

important role in verifying compliance. 

Some noted that global recognition of 

food safety and food defense efforts 

should be developed. One country 

specifically requested that we recognize 

foreign fresh produce initiatives as 

equivalent oversight of the industry. 

We agree that foreign governments 

will play an important part in bringing 

about compliance with a final produce 

rule with respect to foreign products. 

We have already begun to reach out to 

foreign governments regarding the 

requirements of FSMA and will 

continue to provide technical assistance 

as we move closer to finalizing rules 

issued under FSMA authorities. There 

are several provisions of FSMA that 

directly relate to these partnerships. 

Section 305 of FSMA specifically 

directs us to develop a plan to build the 

capacity of foreign governments with 

respect to food safety that will include, 

among other things, training of foreign 

governments on our requirements, 

provisions for mutual recognition of 

inspection reports, and provisions for 

multilateral acceptance of laboratory 

methods and testing and detection 

techniques. Under section 307 of FSMA, 

which added section 808 to the FD&C 

Act [21 U.S.C. 384d], we are directed to 

establish a system for the recognition of 

accreditation bodies that accredit thirdparty auditors to certify that eligible 

entities meet certain requirements. 

Under that section, foreign governments 

or agencies of foreign governments, may 

be accredited as third party auditors 

who could help to ensure compliance 

with a final produce safety rule. Section 

303 of FSMA amended section 801 of 

the FD&C Act to, among other things, 

allow us to designate an agency or 

representative of the foreign government 

of the country from which a food 

originated to provide certification or 

other assurances that certain foods are 

in compliance with the FD&C Act, if 

FDA chooses to require such 

certifications or assurances for certain 

foods. We are working to implement 

these provisions of FSMA. In addition, 

as set forth in subpart P of this proposed 

rule, foreign countries may request 

variances from requirements proposed 

in this rule, provided they meet certain 

conditions. See section V.P. of this 

document for further discussion of the 

process, conditions, and procedures 

related to a request for variance(s). 

In addition to partnering with other 

U.S. agencies and foreign governments, 

several comments discussed the 

strength of industry programs imposed 

throughout the supply chain and urged 

us to leverage these private sector 

efforts. Some commented on the 

importance of verification of 

compliance by qualified and 

independent third parties and 

recognition of third party certification. 

These third parties could be those hired 

by industry, including retailers, to 

ensure the safety of produce from their 

suppliers. However, some comments 

identified duplicative audits and 

excessive documentation as 

problematic, particularly for small 

growers. Other comments recognized 

that importers can play an important 

role in verifying compliance with a final 

produce safety rule and safety of 

imported produce. 

We agree that we should leverage the 

efforts of private supply chain 

management to further compliance with 

a final rule in this area. See discussion 

of our overall enforcement and 

compliance strategy immediately above. 

We also agree that importers will play 

an important role in ensuring the safety 

of produce grown in other countries and 

shipped to the United States. Under 

section 301 of FSMA, importers will 

have to verify that imported covered 

produce is produced in compliance 

with processes and procedures that 

provide the same level of public health 

protection as those required under 

section 419 of the FD&C Act. 

Other comments noted that 

compliance with produce safety 

requirements should be tiered to reflect 

farm size, market requirements and risk. 

One comment noted that there should 

be dedicated inspectors for identified 

groups that may need additional 

assistance. 

We agree that we should prioritize our 

compliance and enforcement efforts. As 

discussed above, we will be targeting 

our education efforts to the smaller 

businesses that may not be as familiar 

with our requirements as some of the 

larger farms. We also propose to give 

small and very small businesses extra 

time to comply with the final rule, as 

discussed in section IV.K of this 

document. With respect to inspections, 

they will, of necessity, be targeted to 

those farms that present the greatest risk 

based, in part, on their association with 

past outbreaks or contamination events 

and the risk associated with the 

agricultural practices they apply in the 

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growing, harvesting, packing, and 

holding of covered produce. 

A few comments mentioned that 

research can play an important part in 

bringing about industry compliance. 

Some noted that foodborne illness 

outbreak investigations needed to be 

improved and used as educational 

opportunities to support food safety 

research. They noted that better 

investigative methods should be 

developed to help reveal possible 

sources of contamination. FDA agrees, 

as reflected in the recent establishment 

of the Coordinated Outbreak Response 

and Evaluation (CORE) Network, which 

is a permanent cadre of FDA experts 

whose full time responsibility is to 

enhance outbreak detection, response, 

and follow up investigations to inform 

future prevention efforts. CORE will 

work with CDC, state and local partners, 

and the food industry to investigate root 

causes of major outbreaks and share 

findings with the food safety 

community. 

Comments also noted that a 

permanent institutional part of 

government should be developed to 

coordinate research, information, 

responses to, and control measures for, 

human pathogens and their evolution in 

the environment, including the farm 

environment, animal production, the 

industrial and commercial environment 

and the medical (healthcare) system. As 

discussed previously, we are pursuing 

regulatory science and research 

activities in collaboration with various 

partners. See section II.E. of this 

document for further information. 

6. Proposed Requirements 

Proposed § 112.191 states that the 

criteria and definitions in this part 

apply in determining whether a food is 

adulterated (1) within the meaning of 

section 402(a)(3) of the Federal Food, 

Drug, and Cosmetic Act in that the food 

has been grown, harvested, packed, or 

held under such conditions that it is 

unfit for food; or (2) within the meaning 

of section 402(a)(4) of the Federal Food, 

Drug, and Cosmetic Act in that the food 

has been prepared, packed, or held 

under insanitary conditions whereby it 

may have become contaminated with 

filth, or whereby it may have been 

rendered injurious to health. The 

criteria and definitions in this part also 

apply in determining whether a food is 

in violation of section 361 of the Public 

Health Service Act (42 U.S.C. 264). 

As discussed in section III of this 

document, FDA proposes these 

regulations under the FD&C Act as 

amended by FSMA, and the Public 

Health Service Act (PHS Act). We note 

that section 419(c)(1)(A) of the FD&C 

Act provides that FDA shall establish in 

this rulemaking ‘‘procedures, processes, 

and practices that the Secretary 

determines to be reasonably necessary 

* * * to provide reasonable assurances 

that the produce is not adulterated 

under section 402 [of the FD&C Act]’’ 

and that similar references to preventing 

adulteration under section 402 of the 

FD&C Act also appear in section 

419(c)(1)(F), (c)(2)(A), (c)(2)(C), and 

(c)(2)(D). In sections V.A. through V.O. 

of this document, we explain how the 

proposed provisions are necessary to 

protect against contamination with 

hazards that may adulterate food. We 

tentatively conclude that the link 

between the proposed provisions and 

the potential for adulteration provides a 

basis for applying the criteria and 

definitions in proposed part 112 in 

determining whether, under particular 

circumstances, a food is adulterated 

under section 402(a)(3) or (a)(4) or in 

violation of section 361 of the PHS Act. 

We also note 402(a)(4) of the FD&C Act 

provides that food is adulterated if it has 

been ‘‘prepared, packed, or held under 

insanitary conditions’’ whereby either of 

the proscribed results may occur. 

‘‘Prepared, packed, or held’’ includes 

growing, harvesting, packing, and 

holding. The common meaning of 

‘‘prepare,’’ as represented by the 

dictionary definition is, in relevant part, 

‘‘to make ready beforehand for some 

purpose, use, or activity * * * to put 

together’’ (Ref. 264). Growing and 

harvesting are operations that make food 

ready for use as food. In addition, 

growing and harvesting at times involve 

holding of food. 

Section 105(c) of FSMA amends 

section 301 of the FD&C Act (21 U.S.C. 

331) by adding a new section—(vv)—to 

the list of acts and the causing thereof 

that are prohibited. Under section 

301(vv), the following act, and the 

causing thereof, is prohibited: ‘‘[t]he 

failure to comply with the requirements 

under section 419 [of the FD&C Act].’’ 

To clearly communicate that failure to 

comply with regulations established 

under section 419 is a prohibited act, 

proposed § 112.192 would establish that 

the failure to comply with the 

requirements of part 112, issued under 

section 419 of the Federal Food, Drug, 

and Cosmetic Act, is a prohibited act 

under section 301(vv) of the Federal 

Food, Drug, and Cosmetic Act (21 U.S.C. 

331(vv)). 

Proposed § 112.193 provides that 

under Section 419(b)(2)(A) of the FD&C 

Act, FDA coordinates education and 

enforcement activities by State, 

Territorial, tribal, and local officials. As 

described above, we plan to work 

closely with State, Territorial, tribal, 

and local partners to develop the 

education and enforcement tools and 

training programs needed to facilitate 

consistent inspection and regulatory 

activities associated with the 

requirements proposed in subparts A 

through O. 

R. Subpart R—Withdrawal of Qualified 

Exemption 

As proposed, subpart R establishes 

the procedures that would govern the 

circumstances and process whereby we 

may issue an order withdrawing a 

qualified exemption applicable to a farm 

in accordance with the requirements of 

§ 112.5. Specifically, proposed § 112.201 

lists the circumstances under which 

FDA can withdraw a qualified 

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 qualified exemption. In addition, 

proposed §§ 112.204 through 112.207 

provide for a process whereby you may 

submit a written appeal (which may 

include a request for a hearing) of an 

order to withdraw a qualified exemption 

applicable to your farm, and proposed 

§§ 112.208 through 112.211 provide a 

procedure for appeals, hearings, and 

decisions on appeals and hearings. 

1. Requirements of Section 419 of the 

FD&C Act 

Section 419(f)(3)(A) of the FD&C Act 

specifies that, ‘‘[i]n the event of an 

active investigation of a foodborne 

illness outbreak that is directly linked to 

a farm subject to an exemption under 

[section 419(f) of the FD&C Act], or if 

the Secretary determines that it is 

necessary to protect the public health 

and prevent or mitigate a foodborne 

illness outbreak based on conduct or 

conditions associated with a farm that 

are material to the safety of the food 

produced or harvested at such farm, the 

Secretary may withdraw the exemption 

provided to such farm under [section 

419(f) of the FD&C Act].’’ Section 419 

does not expressly prescribe the 

procedures for withdrawing a qualified 

exemption provided to a farm under 

section 419(f). We tentatively conclude 

that it is appropriate to be transparent 

about the process we would use to 

withdraw a qualified exemption and 

that we should include the process in 

the proposed rule. 

2. Proposed Requirements 

a. Circumstances for Withdrawal 

Proposed § 112.201 would establish 

the circumstances under which FDA 

can withdraw an exemption applicable 

to a farm. Consistent with Section 

419(f)(3)(A) of the FD&C Act, it states 

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3612 Federal Register / Vol. 78, No. 11 / Wednesday, January 16, 2013 / Proposed Rules 

that we may withdraw your qualified 

exemption under proposed § 112.5: 

(1) In the event of an active 

investigation 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 protect the public health and prevent 

or mitigate a foodborne illness outbreak 

based on conduct or conditions 

associated with your farm that are 

material to the safety of the food that 

would otherwise be covered produce 

grown, harvested, packed or held at 

your farm (proposed § 112.201(b)). 

Proposed § 112.201(a) would 

implement the statutory language of 

section 419(f)(3)(A) of the FD&C Act. An 

outbreak of foodborne illness is the 

occurrence of two or more cases of a 

similar illness resulting from the 

ingestion of a common food. Food can 

become contaminated at many different 

steps in the farm-to-table continuum: 

On the farm; in packing, manufacturing/ 

processing, or distribution facilities; 

during storage or transit; at retail 

establishments; in restaurants; and in 

the home. When foodborne illness is 

associated with food, an investigation 

may enable us to directly link the illness 

to the farm that grew, harvested, packed, 

and/or held the food. 

Proposed § 112.201(b) would also 

implement the statutory language of 

section 419(f)(3)(A) of the FD&C Act, 

which provides that FDA may withdraw 

a qualified exemption available to a 

farm under section 419(f) ‘‘if the 

Secretary determines that it is necessary 

to protect the public health and prevent 

or mitigate a foodborne illness outbreak 

based on conduct or conditions 

associated with a farm that are material 

to the safety of the food produced or 

harvested at such farm.’’ We tentatively 

conclude that the food to which this 

standard applies is food that would 

otherwise be covered produce, because 

that is the food that would be subject to 

this proposed rule if a qualified 

exemption is withdrawn. We also 

tentatively conclude that it is reasonable 

to interpret the word ‘‘produced’’ in this 

standard to refer to the activities within 

the farm definition other than 

harvesting, because this proposed rule 

would apply only to activities within 

the farm definition and the standard 

already uses the word ‘‘harvested.’’ 

Thus, proposed § 112.201(b) would 

provide that FDA may withdraw the 

qualified exemption applicable to a farm 

under proposed § 112.5 if FDA 

determines that it is necessary to protect 

the public health and prevent or 

mitigate a foodborne illness outbreak 

based on conduct or conditions 

associated with a farm that are material 

to the safety of the food that would 

otherwise be covered produce grown, 

harvested, packed, or held at such farm. 

As an example, we may receive reports 

to the Reportable Food Registry under 

section 417 of the FD&C Act about 

contamination of a food, and the reports 

may lead us to investigate a farm that 

grew, harvested, packed or held the 

food. If our investigation finds conduct 

or conditions associated with the farm 

that are material to the safety of the food 

that would otherwise be covered 

produce subject to proposed subparts B 

through O of this rule (for example, 

conduct or conditions that likely led to 

the contamination of the food), we 

would consider withdrawing the 

qualified exemption applicable to the 

farm under proposed § 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 contamination of food that 

would otherwise be covered produce 

with microorganisms of public health 

significance, we would consider 

withdrawing the qualified exemption 

provided to the facility under proposed 

§ 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 withdrawn, any 

officer or qualified employee of FDA 

may issue an order to withdraw the 

exemption. We intend to create and 

maintain a written record of a 

determination that the withdrawal of an 

exemption is warranted and to include 

the basis for the determination in the 

written record. Proposed § 112.202(b) 

would require that an FDA District 

Director in whose district the farm is 

located (or, in the case of a foreign farm, 

the Director of the Office of Compliance 

in the Center for Food Safety and 

Applied Nutrition), or an FDA official 

senior to such Director, must approve an 

order to withdraw the exemption as part 

of the withdrawal determination 

procedure before the order is issued. A 

Regional Food and Drug Director is an 

example of an FDA official senior to a 

District Director. The Deputy Directors 

and Director of the Center for Food 

Safety and Applied Nutrition are 

examples of an FDA official senior to 

the Director of the Office of Compliance. 

Requiring prior approval of a 

withdrawal order by a District Director 

or an FDA official senior to a District 

Director is consistent with the approval 

requirement for a detention order in part 

1, subpart K (Administrative Detention 

of Food for Human or Animal 

Consumption). Requiring prior approval 

of a withdrawal order by the Director of 

the Office of Compliance in the Center 

for Food Safety and Applied Nutrition 

is consistent with current FDA practices 

when dealing with foreign firms. 

Proposed § 112.202(c) would require 

that FDA issue an order to withdraw the 

exemption to the owner, operator, or 

agent in charge of the farm. We 

tentatively conclude that it would be 

appropriate for FDA to issue an 

exemption withdrawal order to any of 

these persons. Proposed § 112.202(d) 

would require that FDA issue an order 

to withdraw the exemption in writing, 

signed and dated by the officer or 

qualified employee of FDA who is 

issuing the order. 

c. Information Included in FDA’s 

Withdrawal Order 

Proposed § 112.203(a) through (h) 

would require that an order to withdraw 

a qualified exemption applicable to a 

farm under § 112.5 include the 

following information: 

(a) The date of the order (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 associated 

with a farm that are material to the 

safety of the food that would otherwise 

be covered produce grown, harvested, 

packed and held at such farm (proposed 

§ 112.203(c)); 

(d) A statement that the farm must 

comply with subpart B through subpart 

O of this part on the date that is 60 

calendar days after the date of the order 

(proposed § 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, email address, and facsimile 

number of the FDA district office and 

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the name of the FDA District Director in 

whose district the farm is located (or, in 

the case of a foreign farm, the same 

information for the Director of the Office 

of Compliance in the Center for Food 

Safety and Applied Nutrition); 

(proposed § 112.203(g)); and 

(h) The name and the title of the FDA 

representative who approved the order 

(proposed § 112.203(h)). 

FDA tentatively concludes that the 

requirements that we propose in 

§ 112.203 would provide the owner, 

operator, or agent in charge of a farm 

subject to a withdrawal with adequate 

notice of the basis for our determination 

to withdraw the exemption and of their 

opportunity to appeal our determination 

and to request an informal hearing. The 

proposed notification procedures are 

similar to and consistent with the 

notification requirements in other 

regulations involving administrative 

action, such as administrative detention 

of food under § 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 Withdrawal 

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 resume within 60 

calendar days, before the beginning of 

operations in the next growing season; 

or (b) appeal the order within 10 

calendar days of the date of the order in 

accordance with the requirements of 

§ 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 health. We 

tentatively conclude that ten calendar 

days for the submission of an appeal 

from the date of the receipt of a 

withdrawal order is appropriate for 

purposes of the efficient adjudication of 

the appeal of a withdrawal order and 

would provide reasonable due process 

that comes to closure sufficiently in 

advance of the effective date of the order 

to provide an opportunity for the farm 

to come into compliance if we deny the 

appeal. 

e. Procedure for Appealing a 

Withdrawal Order (Including Requests 

for Informal Hearing) 

Proposed § 112.205(a) would establish 

that submission of an appeal, including 

submission of a request for an informal 

hearing, will not delay or stay any 

administrative action, including 

enforcement action by FDA, unless the 

Commissioner of Food and Drugs, as a 

matter of discretion, determines that 

delay or a stay is in the public interest. 

For example, the submission of an 

appeal of a withdrawal order with a 

request for an informal hearing would 

not prevent FDA from simultaneously 

detaining food from the farm under 

section 304(h) of the FD&C Act, seeking 

seizure of food from the farm under 

section 304(a) of the FD&C Act, or 

seeking or enforcing an injunction 

under section 302 of the FD&C Act. 

Proposed § 112.205(b) would require 

that, if the owner, operator, or agent in 

charge of the farm appeals the order, 

and FDA confirms the order, the owner, 

operator, or agent in charge of the farm 

must comply with applicable 

requirements of this part within 60 

calendar days of the date of the order or, 

if operations have ceased and will not 

resume within 60 calendar days, before 

the beginning of operations in the next 

growing season. Proposed § 112.205(b) 

would make clear that the 60 calendar 

day time frame for compliance applies 

regardless of whether the owner, 

operator, or agent in charge of a farm 

requests, and FDA grants, a hearing. As 

already discussed, FDA tentatively 

concludes that the circumstances that 

lead to a determination that an 

exemption should be withdrawn 

warrant prompt compliance in the 

interest of public health. 

Proposed § 112.206(a) would require 

that, to appeal an order to withdraw a 

qualified exemption applicable to a farm 

under § 112.5, the owner, operator, or 

agent in charge of the farm must: (1) 

Submit the appeal in writing to the FDA 

District Director in whose district the 

farm is located (or, in the case of a 

foreign farm, to the Director of the 

Office of Compliance in the Center for 

Food Safety and Applied Nutrition), at 

the mailing address, email address, or 

facsimile number identified in the order 

within 10 calendar days of the date of 

the order; and (2) respond with 

particularity to the facts and issues 

contained in the order, including any 

supporting documentation upon which 

the owner, operator or agent in charge 

of the farm relies. Allowing the owner, 

operator, or agent in charge of the farm 

to submit an appeal in person, by mail, 

email, or fax would provide for 

flexibility as well as speed. For 

example, submitting in person would 

give the owner, operator, or agent in 

charge direct knowledge that the request 

for appeal had been delivered and 

received. Email and fax are 

instantaneous, and overnight mail 

delivery services are readily available to 

those who choose to use them; however, 

the ten day time frame for appeal of the 

order would not require the use of 

overnight mail delivery. For clarity, 

proposed § 112.206(a)(1) would repeat 

the 10 calendar day time frame that 

would be established in proposed 

§ 112.204 and would not establish any 

new requirement. Any appeal would 

need to be written in order for FDA to 

evaluate the basis for the appeal. We are 

proposing that a written appeal would 

need to address with particularity all of 

the issues raised in the withdrawal 

order and include all supporting 

documentation so that we would be able 

to issue a final determination as to the 

disposition of the appeal solely on the 

basis of the materials submitted as part 

of the written appeal. 

Proposed § 112.206(b) would provide 

that, in a written appeal of the order 

withdrawing an exemption provided 

under § 112.5, the owner, operator, or 

agent in charge of the farm may include 

a written request for an informal hearing 

as provided in § 112.207. 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). However, 

if the owner, operator, or agent in charge 

of the farm does not request an informal 

hearing at the time the written appeal is 

submitted, the owner, operator, or agent 

in charge of the farm will not be entitled 

to an informal hearing. Instead, FDA 

will make a final decision based on the 

written appeal and its supporting 

materials. 

Proposed § 112.207(a)(1) would 

provide that, if the owner, operator, or 

agent in charge of the farm appeals the 

order, the owner, operator, or agent in 

charge of the farm may request an 

informal hearing. Proposed 

§ 112.207(a)(1) would restate 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, operator, or agent in charge of 

the farm appeals the order, the owner, 

operator, or agent in charge of the farm 

must submit any request for an informal 

hearing together with its written appeal 

submitted in accordance with § 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 

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3614 Federal Register / Vol. 78, No. 11 / Wednesday, January 16, 2013 / Proposed Rules 

that the owner, operator, or agent in 

charge of the farm would be required to 

submit a written appeal is appropriate 

for purposes of the efficient 

adjudication of the appeal of a 

withdrawal order and would provide 

reasonable due process that would come 

to closure sufficiently in advance of the 

effective date of the order to provide an 

opportunity for the farm to come into 

compliance if we deny the appeal. 

Proposed § 112.207(b) would establish 

that a request for an informal hearing 

may be denied, in whole or in part, if 

the presiding officer determines that no 

genuine and substantial issue of 

material fact has been raised by the 

material submitted. Proposed 

§ 112.207(b) would also provide that if 

the presiding officer determines that a 

hearing is not justified, written notice of 

the determination will be given to the 

owner, operator, or agent in charge of 

the farm explaining the reason for the 

denial. Under proposed § 112.206(a), a 

written appeal would be required to 

respond with particularity to the facts 

and issues contained in the withdrawal 

order, including any supporting 

documentation upon which the owner, 

operator or agent in charge of the farm 

relies. If the materials submitted do not 

directly address the facts and issues 

contained in the withdrawal order in a 

manner that suggests that there is a 

genuine dispute regarding the material 

facts contained in the order, the 

presiding officer may determine that an 

informal hearing is not warranted. The 

presiding officer may include written 

notice of the determination that a 

hearing is not justified as part of the 

final decision on the appeal. 

f. Procedure for Appeals (Including 

Informal Hearings) 

Proposed § 112.208(a) would establish 

that, if the owner, operator or agent in 

charge of the farm requests an informal 

hearing, and FDA grants the request, the 

hearing will be held within 10 calendar 

days after the date the appeal is filed or, 

if applicable, within a time frame agreed 

upon in writing by the owner, operator, 

or agent in charge of the farm and FDA. 

We tentatively conclude that, if we grant 

a request for an informal hearing, 

holding the hearing within 10 calendar 

days, or within an alternative time 

frame as agreed upon in writing, is 

appropriate for purposes of the efficient 

adjudication of the appeal of a 

withdrawal order and would provide 

reasonable due process that would come 

to closure sufficiently in advance of the 

effective date of the order to provide an 

opportunity for the farm to come into 

compliance if we deny the appeal. 

Proposed 112.208(b) would establish 

that the presiding officer may require 

that a hearing conducted under this 

subpart be completed within 1 calendar 

day, as appropriate. We tentatively 

conclude that, if we grant a request for 

an informal hearing, limiting the time 

for the hearing itself to be completed 

within 1 calendar day is appropriate for 

purposes of the efficient adjudication of 

the appeal of a withdrawal order and 

would provide reasonable due process 

that would come to closure sufficiently 

in advance of the effective date of the 

order to provide an opportunity for the 

farm to come into compliance if we 

deny the appeal. 

Proposed § 112.208(c)(1) through (7) 

would establish that, if the owner, 

operator or agent in charge of the farm 

requests an informal hearing, and FDA 

grants the request, FDA must conduct 

the hearing in accordance with part 16, 

except that: 

(1) The order withdrawing an 

exemption under § 112.5, rather than 

the notice under § 16.22(a), provides 

notice of opportunity for a hearing 

under this section and is part of the 

administrative record of the regulatory 

hearing under § 16.80(a) of this chapter. 

(2) A request for a hearing under this 

subpart must be addressed to the FDA 

District Director (or, in the case of a 

foreign farm, the Director of the Office 

of Compliance in the Center for Food 

Safety and Applied Nutrition) as 

provided in the order withdrawing an 

exemption. 

(3) Section 112.209, rather than 

§ 16.42(a), describes the FDA employees 

who preside at hearings under this 

subpart. 

(4) Section 16.60(e) and (f) of this 

chapter does not apply to a hearing 

under this subpart. The presiding officer 

must prepare a written report of the 

hearing. All written material presented 

at the hearing will be attached to the 

report. The presiding officer must 

include as part of the report of the 

hearing a finding on the credibility of 

witnesses (other than expert witnesses) 

whenever credibility is a material issue, 

and must include a proposed decision, 

with a statement of reasons. The hearing 

participant may review and comment on 

the presiding officer’s report within 2 

calendar days of issuance of the report. 

The presiding officer will then issue the 

final decision. 

(5) Section 16.80(a)(4) of this chapter 

does not apply to a regulatory hearing 

under this subpart. The presiding 

officer’s report of the hearing and any 

comments on the report by the hearing 

participant under § 112.208(c)(4) are 

part of the administrative record. 

(6) No party shall have the right, 

under § 16.119 of this chapter to 

petition the Commissioner of Food and 

Drugs for reconsideration or a stay of the 

presiding officer’s final decision. 

(7) If FDA grants a request for an 

informal hearing on an appeal of an 

order withdrawing an exemption, the 

hearing must be conducted as a 

regulatory hearing pursuant 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 hearing under 

this subpart, the administrative record 

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 

proceeding 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 

under part 16. Section 419 of the FD&C 

Act does not expressly provide for a 

hearing if circumstances lead FDA to 

determine that a qualified exemption 

provided to a farm under proposed 

§ 112.5 should be withdrawn. However, 

we tentatively conclude as a matter of 

agency discretion that providing an 

opportunity for a hearing by regulation 

in this subpart of the proposed rule 

would provide appropriate process to 

the owner, operator, or agent in charge 

of a farm subject to withdrawal of the 

farm’s qualified exemption. We also 

tentatively conclude that the modified 

part 16 procedures contained in this 

proposed rule would provide the owner, 

operator, or agent in charge of a farm 

subject to a withdrawal order sufficient 

fairness and due process while enabling 

FDA to expeditiously adjudicate an 

appeal of a withdrawal order for which 

an informal hearing has been granted. 

We seek comment on this proposed 

process. 

Section 16.119 provides that, after any 

final administrative action that is the 

subject of a hearing under part 16, any 

party may petition the Commissioner for 

reconsideration of any part or all of the 

decision or action under § 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 

withdrawing a qualified exemption 

provided under proposed § 112.5. The 

circumstances that may lead FDA to 

withdraw a qualified exemption include 

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an active investigation of a foodborne 

illness outbreak that is directly linked to 

a farm, or our determination that it is 

necessary to protect the public health 

and prevent or mitigate a foodborne 

illness outbreak based on conduct or 

conditions associated with a farm that 

are material to the safety of the food that 

would otherwise be covered produce 

grown, harvested, packed, or held at 

such farm. Such circumstances require 

prompt action. Under § 16.120, a farm 

that disagrees with FDA’s decision to 

withdraw 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 Director 

or another FDA official senior to an FDA 

District Director. Under § 16.42(b), an 

officer presiding over an informal 

hearing is to be free from bias or 

prejudice and may not have participated 

in the investigation or action that is the 

subject of the hearing or be subordinate 

to a person, other than the 

Commissioner, who has participated in 

such investigation or action. An order 

for the withdrawal of a qualified 

exemption applicable to a farm must be 

approved by a District Director or an 

official senior to a District Director. It is, 

therefore, necessary that appeals of a 

decision to issue a withdrawal order 

should be handled by persons in 

positions senior to the District Directors. 

The Regional Food and Drug Director is 

such a person and could be from the 

same region where the farm is located, 

provided that the Regional Food and 

Drug Director did not participate in the 

determination that an exemption should 

be withdrawn and is otherwise free from 

bias or prejudice. Alternatively, the 

Regional Food and Drug Director could 

be from a different region than the 

region where the farm is located, for 

example in the event the Regional Food 

and Drug Director for the region in 

which the farm is located is the FDA 

official who approved the withdrawal 

order. Any Office Director of FDA’s 

Office of Regulatory Affairs could 

preside at a hearing, provided that the 

Office Director did not participate in the 

determination that an exemption should 

be withdrawn and is otherwise free from 

bias or prejudice. 

h. Decisions on Appeals (Including 

Informal Hearings) 

Proposed § 112.210(a) would require 

that, if the owner, operator, or agent in 

charge of a farm appeals the order 

without requesting a hearing, the 

presiding officer must issue a written 

report that includes a final decision 

confirming or revoking the withdrawal 

by the tenth calendar day after the 

appeal is filed. Under proposed 

§ 112.201, FDA would issue a 

withdrawal order either in the event of 

an active investigation of a foodborne 

illness outbreak that is directly linked to 

a farm or if we determine that an 

exemption withdrawal is necessary to 

protect the public health and prevent or 

mitigate a foodborne illness outbreak 

based on conduct or conditions 

associated with a farm that are material 

to the safety of the food that would 

otherwise be covered produce grown, 

harvested, packed, or held by the farm. 

We tentatively conclude that we will 

need 10 calendar days to review the 

written appeal and the materials 

submitted with the written appeal, and 

that a final decision confirming or 

revoking a withdrawal order should be 

issued as quickly as possible in the 

interest of the public health and to 

provide reasonable due process that 

would come to closure sufficiently in 

advance of the effective date of the order 

to provide an opportunity for the farm 

to come into compliance if we deny the 

appeal. 

Proposed § 112.210(b)(1) would 

require that, if the owner, operator, or 

agent in charge of a farm appeals the 

order and requests an informal hearing 

and, if FDA grants the request for a 

hearing and the hearing is held, the 

presiding officer must provide a 2 

calendar day opportunity for the hearing 

participants to review and submit 

comments on the report of the hearing 

under § 112.208(c)(4), and must issue a 

final decision within the 10-calendar 

day period after the hearing is held. We 

tentatively conclude that it is 

appropriate to grant the owner, operator, 

or agent in charge of a farm subject to 

a withdrawal order the opportunity to 

review and submit comments to the 

presiding officer’s report because the 

report is part of the record of a final 

agency action (see discussion of 

proposed § 112.211(d)) that is not 

subject to further reconsideration by 

FDA. The presiding officer would have 

discretion to determine whether to 

revise the report of the hearing in light 

of any comments that might be 

submitted by any of the hearing 

participants. 

Proposed § 112.210(b)(2) would 

require that, if the owner, operator, or 

agent in charge of a farm appeals the 

order and requests an informal hearing 

and if FDA denies the request for a 

hearing, the presiding officer must issue 

a final decision on the appeal 

confirming or revoking the withdrawal 

within 10 calendar days after the date 

the appeal is filed. We tentatively 

conclude that ten calendar days for the 

presiding officer to issue a final decision 

is appropriate for purposes of the 

efficient adjudication of the appeal of a 

withdrawal order, would provide 

reasonable due process that would come 

to closure sufficiently in advance of the 

effective date of the order to provide an 

opportunity for the farm to come into 

compliance if we deny the appeal, and 

is in the interest of public health. 

i. Revocation of Withdrawal Order 

Proposed § 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 the order and 

requests an informal hearing, FDA 

grants the request for an informal 

hearing, and the presiding officer does 

not confirm the order within the 10 

calendar days after the hearing, or issues 

a decision revoking the order within 

that time (proposed § 112.211(a)); or 

(b) The owner, operator, or agent in 

charge of the farm appeals the order and 

requests an informal hearing, FDA 

denies the request for an informal 

hearing, and FDA does not confirm the 

order within the 10 calendar days after 

the appeal is filed, or issues a decision 

revoking the order within that time 

(proposed § 112.211(b)); or 

(c) The owner, operator, or agent in 

charge of the farm appeals the order 

without requesting an informal hearing, 

and FDA does not confirm the order 

within the 10 calendar days after the 

appeal is filed, or issues a decision 

revoking the order within that time 

(proposed § 112.211(c)). 

We tentatively conclude that an order 

to withdraw an exemption may be 

revoked in one of two manners. First, 

we are proposing that the FDA officer 

responsible for adjudicating the appeal 

and presiding over a hearing, if one is 

granted, may expressly issue a written 

decision revoking the order within the 

specified 10 calendar day time frame. 

Second, we are proposing that the 

failure of the FDA officer responsible for 

adjudicating an appeal to issue a final 

decision expressly confirming the order 

within the specified time frames will 

also serve to revoke the order. We 

tentatively conclude that fairness would 

warrant the revocation of a withdrawal 

order if FDA is unable to meet the 

proposed deadlines for expressly 

confirming an order. 

Proposed § 112.211(d) would 

establish that confirmation of a 

withdrawal order by the presiding 

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3616 Federal Register / Vol. 78, No. 11 / Wednesday, January 16, 2013 / Proposed Rules 

officer is considered a final agency 

action for purposes of section 702 of 

title 5 of the United States Code (5 

U.S.C. 702). A confirmation of an order 

withdrawing an exemption therefore 

would be reviewable by the courts 

under section 702 of title 5 and in 

accordance with § 10.45 (21 CFR 10.45). 

3. Conforming Amendment to 21 CFR 

Part 16 

We propose to amend § 16.1(b)(2) to 

include part 112, subpart R, relating to 

the withdrawal of a qualified exemption 

applicable to a farm, to the list of 

regulatory provisions under which 

regulatory hearings are available. 

VI. Preliminary Regulatory Impact 

Analysis 

A. Overview 

FDA has examined the impacts of this 

proposed rule under Executive Order 

12866, Executive Order 13563, the 

Regulatory Flexibility Act (5 U.S.C. 

601–612), and the Unfunded Mandates 

Reform Act of 1995 (Pub. L.104–4). 

Executive Orders 12866 and 13563 

direct agencies to assess all costs and 

benefits of available regulatory 

alternatives and, when regulation is 

necessary, to select regulatory 

approaches that maximize net benefits 

(including potential economic, 

environmental, public health and safety, 

and other advantages; distributive 

impacts; and equity). FDA has 

developed a preliminary regulatory 

impact analysis (PRIA) that presents the 

benefits and costs of this proposed rule 

(Ref. 265). FDA believes that the 

proposed rule will be an economically 

significant regulatory action as defined 

by Executive Order 12866. FDA requests 

comments on the PRIA. 

B. Regulatory Flexibility Act 

The Regulatory Flexibility Act 

requires agencies to analyze regulatory 

options that would minimize any 

significant impact of a rule on small 

entities. Because many small businesses 

will need to implement a number of 

new provisions, FDA acknowledges that 

the final rules resulting from this 

proposed rule will have a significant 

economic impact on a substantial 

number of small entities. 

C. Small Business Regulatory 

Enforcement Fairness Act of 1996 

The Small Business Regulatory 

Enforcement Fairness Act of 1996 (Pub. 

L. 104–121) defines a major rule for the 

purpose of congressional review as 

having caused or being likely to cause 

one or more of the following: An annual 

effect on the economy of $100 million 

or more; a major increase in costs or 

prices; significant adverse effects on 

competition, employment, productivity, 

or innovation; or significant adverse 

effects on the ability of United Statesbased enterprises to compete with 

foreign-based enterprises in domestic or 

export markets. In accordance with the 

Small Business Regulatory Enforcement 

Fairness Act, the Office of Management 

and Budget (OMB) has determined that 

this proposed rule is a major rule for the 

purpose of congressional review. 

D. Unfunded Mandates Reform Act of 

1995 

Section 202(a) of the Unfunded 

Mandates Reform Act of 1995 requires 

that agencies prepare a written 

statement, which includes an 

assessment of anticipated costs and 

benefits, before proposing ‘‘any rule that 

includes any Federal mandate that may 

result in the expenditure by State, local, 

and tribal governments, in the aggregate, 

or by the private sector, of $100,000,000 

or more (adjusted annually for inflation) 

in any one year.’’ The current threshold 

after adjustment for inflation is $136 

million, using the most current (2010) 

Implicit Price Deflator for the Gross 

Domestic Product. FDA expects that the 

proposed rule will result in a 1-year 

expenditure that would exceed this 

amount. 

E. Paperwork Reduction Act of 1995 

This proposed rule contains 

information collection provisions that 

are subject to review by OMB under the 

Paperwork Reduction Act of 1995 (44 

U.S.C. 3501–3520). The collections of 

information in the proposed rule have 

been submitted to OMB for review 

under Section 3507(d) of the Paperwork 

Reduction Act of 1995. FDA invites 

comments on: (1) Whether the proposed 

collection of information is necessary 

for the proper performance of FDA’s 

functions, including whether the 

information will have practical utility; 

(2) the accuracy of FDA’s estimate of the 

burden of the proposed collection of 

information, including the validity of 

the methodology and assumptions used; 

(3) ways to enhance the quality, utility, 

and clarity of the information to be 

collected; and (4) ways to minimize the 

burden of the collection of information 

on respondents, including through the 

use of automated collection techniques, 

when appropriate, and other forms of 

information technology. 

To ensure that comments on 

information collection are received, 

OMB recommends that written 

comments be faxed to the Office of 

Information and Regulatory Affairs, 

OMB, Attn: FDA Desk Officer, FAX: 

202–395–7285, or emailed to 

oira_submission@omb.eop.gov. All 

comments should be identified with the 

title ‘‘Standards for the Growing, 

Harvesting, Packing, and Holding of 

Produce for Human Consumption.’’ In 

compliance with the Paperwork 

Reduction Act of 1995 (44 U.S.C. 

3407(d)), the Agency has submitted the 

information collection provisions of this 

proposed rule to OMB for review. These 

requirements will not be effective until 

FDA obtains OMB approval. FDA will 

publish a notice concerning OMB 

approval of these requirements in the 

Federal Register. 

F. Public Access to the Analyses 

The analyses that FDA has performed 

in order to examine the impacts of this 

proposed rule under Executive Order 

12866, Executive Order 13563, the 

Regulatory Flexibility Act (5 U.S.C. 

601–612), the Unfunded Mandates 

Reform Act of 1995 (Pub. L. 104–4), and 

the Paperwork Reduction Act of 1995 

(44 U.S.C. 3501–3520) are available to 

the public in the docket for this 

proposed rule (Ref. 265). 

VII. Analysis of Environmental Impact 

The agency has prepared a categorical 

exclusion determination relying upon 

the categorical exclusion at 21 CFR 

25.30(j) and the determination that there 

are no extraordinary circumstances 

which raise the potential for this rule to 

individually or cumulatively have a 

significant effect on the human 

environment (Ref. 266). FDA requests 

comment on its analysis and 

determination. As set out in more detail 

in Section IX of this document, to the 

extent there are any environmental 

effects that FDA should take into 

consideration as it prepares a final rule, 

FDA requests public comment and 

supporting data or other information 

(e.g., studies, data, reports). The agency 

will evaluate the information and input 

received in response to this proposed 

rule, including the specific questions 

listed in section IX of this document. 

Although FDA finds that no EIS is 

necessary for this proposed rule, if in 

response to comment received, FDA 

prepares an EA or EIS, it will provide 

notice and an opportunity for public 

review and comment on any such 

document. 

VIII. Federalism 

FDA has analyzed this proposed rule 

in accordance with the principles set 

forth in Executive Order 13132. FDA 

has determined that the proposed rule, 

if finalized, would not contain policies 

that would have substantial direct 

effects on the States, on the relationship 

between the National Government and 

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the States, or on the distribution of 

power and responsibilities among the 

various levels of government. 

Accordingly, the agency tentatively 

concludes that the proposed rule does 

not contain policies that have 

federalism implications as defined in 

the Executive order and, consequently, 

a federalism summary impact statement 

is not required. 

IX. Comments 

Interested persons may submit to the 

Division of Dockets Management (see 

ADDRESSES) either electronic or written 

comments regarding this document. It is 

only necessary to send one set of 

comments. It is no longer necessary to 

send two copies of mailed comments. 

Identify comments with the docket 

number found in brackets in the 

heading of this document. Received 

comments may be seen in the Division 

of Dockets Management between 9 a.m. 

and 4 p.m., Monday through Friday. 

Comments on proposed provisions 

and related issues—We seek comment 

on the need for, and appropriateness of, 

the various provisions proposed in this 

rule and our accompanying rationale. 

Specifically, we seek comment on the 

following issues: 

• Proposed provisions in subpart A, 

including: 

Æ proposed §§ 112.1 and 112.2, 

including the produce that would be 

covered or not covered by the rule; the 

list of produce that would not be 

covered by the rule because it is rarely 

consumed raw (including asparagus, 

bok choy, and cranberries); and the 

proposed exemption for produce that 

receives commercial processing, 

including the types of processing that 

should qualify for this exemption; 

Æ proposed definitions in § 112.3(c), 

including those of agricultural water, 

hazard, reasonably foreseeable hazard, 

produce, humus, production batch of 

sprouts, and yard trimmings; 

Æ proposed definitions of small and 

very small businesses in § 112.3(b); as 

well as the proposed exclusion of 

certain farms from the scope of this rule 

based sales in § 112.4(a); 

Æ whether and how we should 

require farms that meet the criteria for 

the qualified exemption to establish and 

maintain documentation of the basis for 

their exemption; 

Æ the feasibility of the labeling 

provisions in proposed 112.6(b), 

particularly in the case of consolidating 

produce from several farm locations. 

• Proposed general requirements in 

§ 112.11, including 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 

standards in proposed subparts C 

through O; and the proposed allowance 

in § 112.12 for alternatives to certain 

specified requirements, including 

appropriateness of the list of permitted 

alternatives. Are there other proposed 

provisions for which we should permit 

alternatives and, if so, under what, if 

any, additional or different criteria than 

those proposed in § 112.12(b) and (c)? 

• Proposed provisions in subparts C 

and D directed to personnel training, 

and health and hygiene, including the 

proposed requirements for training on 

principles of food hygiene and food 

safety, and for the maintenance of 

adequate personal cleanliness and 

hygienic practices when handling 

covered produce or food-contact 

surfaces during covered activities, 

including the provisions relevant to use 

of gloves and hand sanitizers; 

• Proposed provisions directed to 

water, including those related to water 

quality, microbial indicators, and testing 

in §§ 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: 

Æ Are the provisions in §§ 112.44– 

112.46 appropriately tailored to the risk 

posed by the manner in which the water 

is used? 

Æ Are the microbial standards 

specified in these provisions 

appropriate for the specified intended 

uses? For example, are the microbial 

standards appropriately tailored to uses 

such as direct application of irrigation 

water? 

Æ 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? 

Æ Is there a need for a provision 

specifically related to disinfection 

treatment of re-circulated or single pass 

water used during and after harvest? 

Æ Are there any alternative options 

not considered in the proposed rule? 

• Proposed provisions in subpart F 

directed to soil amendments, including 

those related to status, treatment, 

application restrictions, minimum 

application intervals, and recordkeeping 

(including the requirement related to 

documentation such as Certificates of 

Conformance); our focus on biological 

soil amendments of animal origin; any 

alternative options that we have not 

considered in this proposed rule; and 

the risk presented by the use of 

biological soil amendments in sprouting 

and whether that practice should be 

prohibited; 

• Proposed provisions in subparts I, 

K, and L, including proposed § 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 prevent 

formation of botulinum toxin; 

specifically: 

Æ 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 partiallyenclosed building where there is a 

reasonable probability of contamination 

of covered produce, and our tentative 

conclusion that, accordingly, crops that 

grow completely underground would 

not be subject to the proposed 

provisions of subpart I? 

Æ With respect to dropped produce, 

should proposed § 112.114 apply to all 

commodities or should we provide for 

certain exceptions (and, if so, under 

what criteria)? Does proposed § 112.114 

appropriately address produce (such as 

almonds) that is intentionally dropped 

to the ground during harvesting and 

where such harvesting does not cause 

bruising or damage to the produce? 

Should produce with peelable skin be 

excluded? 

Æ Is proposed § 112.115 a reasonably 

necessary measure to ensure the safety 

of packaged covered produce? Are there 

specific types or conditions of modified 

or reduced oxygen packaging methods 

that may or may not increase the risk of 

formation of botulinum toxin? 

• Proposed provisions specific to 

sprouts in subpart M, including 

treatment of seeds and beans; microbial 

indicators and frequency of 

environmental monitoring; and 

requirement to establish and implement 

a written environmental monitoring 

plan (§ 112.144(a)) and sampling plan 

for each production batch of sprouts 

(§ 112.146(a)); as well as whether soilgrown sprouts should be subject to the 

proposed requirements, and whether 

and how to establish a supplier 

approval and verification program for 

seeds and beans used for sprouting; 

• Proposed provisions in subpart N, 

including methods and allowance for 

alternative methods to be used provided 

they are at least equivalent to the 

proposed method in accuracy, 

precision, and sensitivity; 

• Proposed requirements related to 

documentation and records in subpart 

O, including the requirement for a 

supervisor or responsible party to 

review certain records, and whether 

there are any circumstances that would 

warrant not applying part 11 to records 

that would be required to be kept under 

part 112; 

• Proposed provisions in subpart P 

for variances, including related process 

and scientific data and information to 

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3618 Federal Register / Vol. 78, No. 11 / Wednesday, January 16, 2013 / Proposed Rules 

support a request for variance, and 

circumstances for approval or denial of 

a request for variance and for 

modification or revocation of an 

approved variance; Are there any 

specific concerns that we should 

consider in finalizing the procedures 

and processes for requests for variances, 

as applicable to foreign governments? 

• Overall implementation and 

compliance strategy and proposed 

provisions in subpart Q, including 

specific strategies we should employ in 

order to best prioritize our 

implementation of the rule, and 

coordination of education and 

enforcement activities by relevant State, 

Territorial, tribal, and local authorities; 

and 

• Proposed provisions in subpart R 

for withdrawal of a qualified exemption, 

including related process and 

timeframes for actions to be taken by 

FDA or farms. 

• Regarding the scope of the 

recordkeeping requirements, are there 

alternative options that should be 

considered? 

• Regarding the handwashing and 

toilet facility requirements, are our 

proposals reasonably consistent with 

current model practices or are there 

alternatives not considered in the 

proposed rule? 

Regulatory approach—As discussed 

in section IV of this document, we have 

tentatively concluded that we should 

use a regulatory framework based on 

practices, procedures, and processes 

associated with growing, harvesting, 

packing, and holding of all covered 

produce. We considered and rejected 

the option to develop a framework that 

(based solely on a history of outbreaks 

or illnesses associated with the 

commodity) would be applicable to 

individual commodities or classes of 

commodities. Relevant references on the 

subject of produce safety, as well as the 

QAR, identify common on-farm routes 

of contamination, such as personnel 

training, health, and hygiene; domestic 

and wild animals; biological soil 

amendments of animal origin; 

agricultural water; and equipment and 

buildings. Procedures, processes and 

practices in each of these on-farm routes 

of contamination have the potential to 

introduce biological hazards into or 

onto any covered produce. Therefore, 

we are proposing an integrated 

approach to prescribe standards for each 

of these on-farm routes of contamination 

that we have tentatively determined are 

reasonably necessary to prevent the 

introduction of known or reasonably 

foreseeable biological hazards and to 

provide reasonable assurances that 

produce is not adulterated under section 

402 of the FD&C Act. We also recognize 

the need for additional standards 

specifically tailored to the growing, 

harvesting, packing and holding of 

sprouts, and have proposed minimum 

necessary standards for sprouts. We 

seek comment on our tentative 

conclusions related to this issue and the 

proposed regulatory approach described 

in section IV of the document. In 

addition, we seek comment on the 

following: 

• Are there any alternative 

approaches that we should consider in 

establishing science-based minimum 

standards for the safe production and 

harvesting of produce and to minimize 

the risk of serious adverse health 

consequences or death? 

• Are there specific commodities or 

categories of commodities that should 

be excluded from the scope of the rule, 

based on data related to their relative 

risk considerations? (Note that under 

our proposed integrated approach, we 

propose to exempt certain commodities, 

including a specified list of produce that 

is rarely consumed raw, and produce 

that receives commercial processing that 

adequately reduces the presence of 

microorganisms of public health 

significance; see section V.A.2.a. of this 

rule.) 

• For example, the QAR ranked 

certain produce commodities, such as 

bananas and coconuts, as lower risk for 

illness, in part because such 

commodities are peeled or shelled 

before consumption in a manner that 

can be expected not to transfer 

contamination onto the interior, edible 

portion of the commodity. Should such 

commodities be covered by the rule? Is 

coverage of these commodities 

unnecessary? Should they be covered 

but subject to a less stringent set of 

requirements? 

• Certain commodities are ranked in 

the QAR as presenting a relatively lower 

likelihood of exposure, in part because 

such commodities have fewer potential 

routes of contamination and/or lower 

potential for contamination. In addition, 

some commodities are not known to 

have been associated with outbreaks. 

Some commodities (for example, pears, 

grapefruit, oranges, and lemons) meet 

both of these criteria, considering the 

rankings and outbreak data used in the 

QAR. Should commodities that meet 

both of these criteria be covered by the 

rule? Is coverage of these commodities 

unnecessary? Should they be covered 

but subject to a less stringent set of 

requirements? How should the rule 

address the changing nature of outbreak 

data over time? 

• How should we account for 

uncovered commodities in considering 

a commodity-specific approach that 

relies on outbreak data? 

• Are there pathogen surveillance 

data from sampling programs focusing 

on produce commodities that have no 

history of known outbreaks that would 

be useful in considering a commodityspecific approach? 

• Can commodity characteristics be 

used as a basis to consider a 

commodity-specific approach? While 

the outbreak data show no consistent 

pattern that can be matched to 

commodity characteristics such as 

growth habit, our QAR shows that 

produce commodities that are ranked as 

higher risk of illness and those ranked 

as lower risk of illness do share some of 

the same characteristics. A further 

refinement of our assessment might be 

helpful in developing a commodityspecific approach based on commodity 

characteristics. Considering the 

qualitative nature of our assessment, are 

there quantitative data sets available 

that would enable a further refinement 

of our assessment? 

• We seek comment on our tentative 

conclusion that produce in both direct 

market channels and other commercial 

channels are subject to the same routes 

of contamination, although the number 

of opportunities for contamination 

during packing and holding may be 

greater for produce in other commercial 

channels as compared to produce in 

direct market channels if there are 

greater numbers of touch points and 

handlers in these channels than there 

are in direct market channels. 

• We seek comment on our tentative 

conclusion that because the statutory 

qualified exemption addresses market 

channels as a possible risk factor, and 

because we identified no data that 

would allow us to otherwise use market 

channels as a factor in covering and 

regulating produce under this proposed 

rule, we should not otherwise use 

market channels as a basis of risk 

categorization in this proposed rule. 

• Are other data or information 

available that would be otherwise useful 

in considering a commodity-specific 

approach? 

• We seek comment on the proposed 

effective and compliance dates. 

• We seek comment on the 

appropriateness of the proposed 

exemptions and partial exemptions. Are 

there additional exemptions and 

relevant data to support such 

exemptions that we should consider? 

Qualitative assessment of risk—We 

seek comment on the QAR, conclusions 

drawn from that assessment, and our 

consideration of those conclusions in 

developing the proposed requirements 

described in this rule. We also request 

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you to submit any data or factual 

information that may help the agency to 

conduct, as warranted, a thorough and 

robust quantitative assessment of risk 

associated with produce production and 

harvesting practices. 

Chemical, physical or radiological 

hazards—We seek comment on our 

tentative conclusion that procedures, 

practices, and processes, which are 

proposed in this rule, are reasonably 

necessary to prevent the introduction of 

biological hazards only, and on 

whether, and to what extent, chemical, 

physical or radiological hazards should 

be covered within the scope of a final 

rule. Are there procedures, practices, or 

processes that minimize the risk of 

serious adverse health consequences or 

death and that are reasonably necessary 

to prevent the introduction of known or 

reasonably foreseeable chemical, 

physical or radiological hazards into 

produce or to provide reasonable 

assurances that produce is not 

adulterated under section 402 of the 

FD&C Act? 

Environmental testing for L. 

monocytogenes or Listeria spp for 

covered produce other than sprouts— 

Proposed § 112.143(a) would require 

testing the growing, harvesting, packing, 

and holding environment for sprouts for 

Listeria species or L. monocytogenes; 

however, we have not proposed to 

require environmental testing for other 

covered produce. A recent outbreak of 

listeriosis from cantaloupes attributed to 

insanitary conditions at a facility that 

washed, packed, cooled and held intact 

cantaloupes (Ref. 267) raises the 

question as to whether specific 

measures are necessary to minimize the 

risk posed by L. monocytogenes as an 

environmental pathogen. As discussed 

in section V.A. of this document, this 

proposed rule would not apply to offfarm facilities such as the facility 

associated with this cantaloupe 

outbreak— such facilities would instead 

be subject to part 110 and may be 

subject to section 418 of the FD&C Act. 

However, the same risk factors and 

potential measures for minimizing risk 

are relevant to both on-farm and offfarm produce washing, packing, cooling, 

and holding practices. Such measures 

could include environmental testing for 

L. monocytogenes or Listeria spp. to 

verify the adequacy of a covered farm’s 

sanitation measures. Because L. 

monocytogenes is a ubiquitous 

microorganism, an intact fruit or 

vegetable could reasonably be expected 

to occasionally be positive for L. 

monocytogenes. Many studies have 

shown the presence of L. 

monocytogenes on fresh, intact produce, 

but there is limited epidemiological 

evidence associating listeriosis with 

produce, especially with intact fruits 

and vegetables (Ref. 268. Ref. 269. Ref. 

270. Ref. 271. Ref. 272. Ref. 267). 

However, this recent outbreak indicates 

that intact produce can be a vehicle for 

listeriosis. What is not known is the 

extent to which, and under what 

circumstances, whole produce 

contaminated with L. monocytogenes 

presents a risk to consumers. The 

outbreak of listeriosis due to 

contamination of intact cantaloupes 

appears to have occurred due to a 

combination of factors, including 

pooled water on the floor of the facility, 

which was also difficult to clean, poorly 

designed equipment that was previously 

used for other commodities, no pre-cool 

step, a truck parked near the packing 

area that had visited a cattle operation, 

and possible low level contamination 

from the growing/harvesting operation 

(Ref. 273). The contribution of 

internalization of the organism and 

growth within the fruit is not known. 

Moreover, it is not known whether all 

of these circumstances are needed for L. 

monocytogenes to present a risk on 

produce or whether any one or more 

would have been sufficient. We also do 

not know the prevalence of L. 

monocytogenes environmental 

contamination of fruit and vegetable 

packing facilities (both on- and offfarm), nor do we know the prevalence 

of L. monocytogenes on produce 

washed, packed, cooled and stored in 

such facilities. We encourage research to 

answer these questions. We request 

comment on whether we should require, 

in a final rule, any or all covered farms 

that wash and pack produce, or that 

only pack produce, to perform 

environmental testing for L. 

monocytogenes or Listeria spp., and any 

criteria that should be employed to 

determine which farms should be 

subjected to such a requirement. 

Operational assessment, food safety 

plans—As discussed in section IV of 

this document, while we recommend 

that farms conduct an operational 

assessment and develop a food safety 

plan, at this time, we are not proposing 

to require them to do so. We request 

comment on whether we should require, 

in a final rule, some or all covered farms 

to perform operational assessments and/ 

or develop a food safety plan, and any 

criteria that should be employed to 

determine which farms should be 

subjected to such a requirement. 

Registration—We are also requesting 

comment about whether we should 

require, in a final rule, that covered 

farms, as described in proposed 

§ 112.4(a), register with FDA. We are not 

aware of a nationwide database of farms, 

nor an accumulation of statewide 

databases, that would enable us to 

identify the names and locations of all 

entities subject to this proposed 

regulation. This would enable us to 

better provide outreach and technical 

assistance to covered entities. In 

addition, while inspection is intended 

to be only a relatively minor part of our 

overall compliance effort (see section 

V.Q. of the document for more 

information on our overall strategy), we 

anticipate performing inspections for 

enforcement purposes. We would use 

the covered farm registration 

information to create a database that we 

would use to allocate inspection 

resources. We are also interested in the 

existence of databases that could help 

us identify covered farms in the absence 

of a registration system, and in the 

appropriate data elements that should 

be collected in a registration system, 

should we decide to set up such a 

system. 

Environmental issues—Consistent 

with § 25.50, FDA is involving the 

public in implementing its NEPA 

procedures applicable to this proposed 

rule. The agency will evaluate the 

information and input received in 

response to this proposed rule, 

including the specific questions below, 

to determine further actions, as 

appropriate. 

Proposed subpart E would establish 

standards for an indicator organism in 

agricultural water applied to covered 

produce, and establish requirements for 

waters that do not meet those standards. 

We are soliciting comments on potential 

means or mechanisms for meeting the 

proposed standards. In your responses, 

please distinguish, to the extent 

appropriate, between sprouts and other 

covered produce. 

1. Do farms that would be covered by 

the proposed rule, if finalized, currently 

treat water used for irrigation directly 

applied to covered produce other than 

sprouts, or water used to irrigate sprouts 

(whether or not it is directly applied)? 

We are seeking comments on pesticides 

used to reduce concentration of 

organisms of concern in water used for 

such irrigation and not pesticides used 

to prevent biofouling (chemigation). 

2. What actions are currently being 

taken by farmers, either on their own or 

at the request of produce handlers or 

sellers to control the bacterial loads in 

water? Please provide data to support 

the information provided. 

3. What water treatment methods do 

farmers use to clean their irrigation 

systems, how broadly are they used, and 

what are the effects on the environment? 

In what amounts or frequency are each 

of these methods applied? Please 

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provide data to support the information 

provided. 

4. Do farms currently use municipal 

water sources to irrigate produce that 

would be covered by this proposed rule, 

if finalized? If so, please provide data on 

the use rate and prevalence of this 

practice, as well as data regarding 

effects on crop productivity of 

disinfection byproducts in municipal 

water used to irrigate produce that 

would be covered by the rule. 

5. What sources of irrigation water 

(for example, municipal water, surface 

water and groundwater) are most 

frequently used? If more than one 

source is available, is there a preference 

for using one source over another? 

Please explain why. 

In addition, we seek comment on 

potential effects of actions taken as a 

result of this rule on water rights/Tribal 

rights. Are water rights or Tribal rights 

likely to be affected by actions taken as 

a result of this rule? If so, how and to 

what extent? 

Proposed subpart F would require the 

use of application method restrictions, 

application intervals, and/or treatment 

of biological soil amendments of animal 

origin to reduce exposure of covered 

produce to organisms of public health 

concern. We recognize that the 

requirements in this section may 

represent a departure from current 

practices. 

1. How do farms that would be 

covered by the proposed rule, if 

finalized, currently manage solid animal 

waste? Manage liquid animal waste? 

2. What is the prevalence of 

composting on farms using methods 

described in proposed subpart F? Please 

provide data or other available 

information on the frequency of such 

composting. 

3. Are composting methods other than 

those described in proposed subpart F 

currently utilized on farms? To what 

extent? Please provide data or other 

available information on the frequency 

of such composting. 

4. Are currently utilized methods of 

composting governed by state, county or 

local laws, ordinances or regulations? 

Please identify in your comments any 

relevant laws, ordinances, or 

regulations, and include copies if 

reasonably feasible. 

5. What are the current laws, 

ordinances, or regulations in produce 

growing areas that govern manure 

handling and storage? How if at all do 

such laws, ordinances, or regulations 

address potential environmental effects 

from methane associated with manure? 

Ammonia? Nitrogen? Phosphorus? 

Under proposed subpart F, manure 

may be chemically treated as an 

alternative to composting that would 

not require use of an application 

interval. We are also soliciting 

comments on available chemical 

treatment methods. 

1. Do farms that would be covered by 

the proposed rule, if finalized, currently 

utilize chemical treatments to prevent or 

minimize pathogens in manure? 

2. What types and quantities of 

chemicals are used for chemical 

treatment of manure? Please describe 

the treatment protocols, including 

application time, containment methods, 

and temperature requirements. 

3. Please provide any data or other 

information relating to the effectiveness, 

and the relative effectiveness, of these 

chemical manure treatments, as well as 

any environmental effects of their use. 

Proposed subpart I would apply when 

under the circumstances there is a 

reasonable probability that animal 

intrusion will contaminate covered 

produce. In such circumstances, 

proposed subpart I would require 

monitoring of those areas that are used 

for a covered activity for evidence of 

animal intrusion immediately prior to 

harvest and as needed during the 

growing season. If significant evidence 

of animal intrusion is found, these 

provisions would require farms to 

evaluate whether the covered produce 

can be harvested in accordance with 

proposed subpart K. Proposed subpart K 

would require taking reasonable 

measures to identify, and not harvest, 

covered produce that is reasonably 

likely to be contaminated, including 

steps to identify and not harvest covered 

produce that is visibly contaminated 

with animal excreta. We are soliciting 

comments on current practices relevant 

to these provisions. 

1. What measures, if any, are 

currently being implemented to prevent 

harvest of produce contaminated by 

excreta deposited by wild animals? If 

there are preferred measures, please 

explain the rationale for such 

preference. Please provide data to 

support the information provided. 

2. Are farms removing vegetation 

bordering outdoor produce growing 

areas or drainages in an effort to deter 

wildlife from entering growing areas? If 

so, what is the current rate at which 

vegetation bordering outdoor produce 

growing areas or drainages is currently 

being removed? Are sediment basins or 

other conservation practices currently 

being removed and at what rate? Please 

provide data or other information to 

support the information provided. 

3. To what extent have farmers taken 

action to exclude wildlife from outdoor 

produce growing areas? What measures 

are being used for these purposes, e.g. 

construction of fences or other physical 

barriers, chemical deterrents, or other 

mechanisms around growing areas to 

exclude wildlife? Please provide data or 

other information to support the 

information provided. 

4. Has the implementation of 

measures to prevent animal intrusion 

negatively impacted habitat for rare or 

declining aquatic or terrestrial wildlife 

species or migratory birds? Please 

provide examples. 

X. References 

The following references have been 

placed on display in the Division of 

Dockets Management (see ADDRESSES) 

and may be seen by interested persons 

between 9 a.m. and 4 p.m., Monday 

through Friday. (FDA has verified the 

Web site addresses, but FDA is not 

responsible for any subsequent changes 

to the Web sites after this document 

publishes in the Federal Register.) 

1. U.S. Department of Health and Human 

Services and U.S. Department of 

Agriculture. Dietary Guidelines for 

Americans, 2010. 2011. www.health.gov/ 

DietaryGuidelines/dga2010/ 

DietaryGuidelines2010.pdf. 

2. Food and Drug Administration. s.v. ‘‘Draft 

Qualitative Assessment of Risk to Public 

Health from On-Farm Contamination of 

Produce.’’ Accessed 2012. 

3. D’Lima, C., Vierk, K., and Food and Drug 

Administration, ‘‘Memorandum to the 

Record’’, 2011. 

4. Smith, M. A. s.v. ‘‘Memorandum to the 

Record.’’ Accessed 2012. 

5. Viazis, S. and Food and Drug 

Administration, ‘‘Memorandum to the 

Record’’, 2011. 

6. Centers for Disease Control and 

Prevention. ‘‘Multistate Outbreaks of 

Salmonella Infections Associated with 

Raw Tomatoes Eaten in Restaurants— 

United States, 2005–2006.’’ MMWR 56, 

no. 35 (2007): 909–911. 

7. Beru, N. and Food and Drug 

Administration. s.v. ‘‘Memorandum to 

the Record.’’ Accessed 2012. 

8. ‘‘Enforcement Reports.’’ Food and Drug 

Administration. http://www.fda.gov/ 

Safety/Recalls/EnforcementReports/

default.htm. Last Modified 2011. 

9. ‘‘Sources of Ionizing Radiation.’’ United 

Nations Scientific Committee on the 

Effects of Atomic Radiation. UNSCEAR 

2008 Report. http://www.unscear.org/

unscear/en/publications/2008_1.html. 

Last Modified 2011. 

10. ‘‘Guidance for Industry: Guide to 

Minimize Microbial Food Safety Hazards 

for Fresh Fruits and Vegetables.’’ Food 

and Drug Administration. http:// 

www.fda.gov/food/

guidancecomplianceregulatory

information/guidancedocuments/ 

produceandplanproducts/

ucm064458.htm. Accessed November 30, 

2011. Last Modified 1998. 

11. ‘‘Letter to Firms that Grow, Pack, or Ship 

Fresh Lettuce and Fresh Tomatoes.’’ 

mstockstill on DSK4VPTVN1PROD with 

Federal Register / Vol. 78, No. 11 / Wednesday, January 16, 2013 / Proposed Rules 3621 

Food and Drug Administration. http:// 

www.fda.gov/Food/FoodSafety/ProductSpecificInformation/

FruitsVegetablesJuices/

GuidanceComplianceRegulatory

Information/ucm118896.htm. Accessed 

December 8, 2011. Last Modified 2004. 

12. ‘‘Letter to California Firms that Grow, 

Pack, Process, or Ship Fresh and Freshcut Lettuce, November 4, 2005.’’ Food 

and Drug Administration. http:// 

www.fda.gov/Food/FoodSafety/ProductSpecificInformation/

FruitsVegetablesJuices/

GuidanceComplianceRegulatory

Information/ucm118911.htm. Accessed 

December 8, 2011. Last Modified 2011. 

13. ‘‘Guidance for Industry: Letter to Firms 

that Grow, Harvest, Sort, Pack, or Ship 

Fresh Cilantro.’’ Food and Drug 

Administration. http://www.fda.gov/

Food/GuidanceCompliance

RegulatoryInformation/

GuidanceDocuments/Produceand

PlanProducts/ucm249401.htm. Accessed 

December 8, 2011. Last Modified 2011. 

14. ‘‘Guidance for Industry: Reducing 

Microbial Food Safety Hazards For 

Sprouted Seeds.’’ Food and Drug 

Administration. http://www.fda.gov/

Food/GuidanceCompliance

RegulatoryInformation/

GuidanceDocuments/ProduceandPlan

Products/ucm120244.htm. Accessed 

December 1, 2011. Last Modified 1999. 

15. ‘‘Guidance for Industry: Sampling and 

Microbial Testing of Spent Irrigation 

Water During Sprout Production.’’ Food 

and Drug Administration. http:// 

www.fda.gov/Food/GuidanceCompliance

RegulatoryInformation/

GuidanceDocuments/

ProduceandPlanProducts/

ucm120246.htm?utm_

campaign=Google2&utm_source=

fdaSearch&utm_medium=website&utm_

term=sprout%20guidance&utm

_content=2. Last Modified 2011. 

16. ‘‘Microbiological Safety Evaluations and 

Recommendations on Sprouted Seed.’’ 

National Advisory Committee on 

Microbiological Criteria for Food. http:// 

www.fda.gov/Food/FoodSafety/ProductSpecificInformation/

FruitsVegetablesJuices/ucm078789.htm. 

Last Modified 1999. 

17. ‘‘Letter from FDA to Seed Suppliers, 

Distributors, and Sprouters.’’ Food and 

Drug Administration. http:// 

www.fda.gov/NewsEvents/PublicHealth

Focus/ucm151758.htm. Accessed 

December 8, 2011. Last Modified 2009. 

18. ‘‘Letter from California Department of 

Public Health to Sprout Manufacturers.’’ 

Pettit, J. M. and California Department of 

Public Health. http://www.fda.gov/

NewsEvents/PublicHealthFocus/ 

ucm152150.htm. Last Modified 2009. 

19. ‘‘Produce Safety From Production to 

Consumption: A Proposed Action Plan to 

Minimize Foodborne Illness Associated 

with Fresh Produce Consumption—June 

2004.’’ Food and Drug Administration. 

http://www.fda.gov/Food/FoodSafety/ 

Product-SpecificInformation/

FruitsVegetablesJuices/

FDAProduceSafetyActivities/ 

ProduceSafetyActionPlan/ 

ucm056859.htm. Accessed December 8, 

2011. Last Modified 2009. 

20. Association of Food and Drug Officials. 

Model Code for Produce Safety, 

Association of Food and Drug Officials 

Model Code for Produce Safety for State 

and Local Regulatory Agencies. 

Association of Food and Drug Officials, 

2009. 

21. Crawford, W., Baloch, M., and Gerrity, K. 

Environmental Assessment Report, FDA 

Foods Program, Non-O157 Shiga ToxinProducing E. coli (STEC). 2010. http:// 

www.fda.gov/downloads/Food/ 

FoodSafety/FoodborneIllness/ 

UCM235923.pdf. Accessed 12–8–2011. 

22. ‘‘Leafy Greens Safety Inititiave—2nd 

Year.’’ Food and Drug Administration. 

http://www.fda.gov/Food/FoodSafety/ 

Product-SpecificInformation/Fruits

VegetablesJuices/FDAProduceSafety

Activities/ucm115898.htm. Accessed 

December 9, 2011. Last Modified 2009. 

23. ‘‘Tomato Safety Initiative.’’ Food and 

Drug Administration. http:// 

www.fda.gov/Food/FoodSafety/ProductSpecificInformation/Fruits

VegetablesJuices/FDA

ProduceSafetyActivities/

ucm115334.htm. Accessed December 9, 

2011. Last Modified 2009. 

24. ‘‘Memorandum of Understanding 

Between the United States Food and 

Drug Administration and the United 

States Department of Agriculture, 

Research, Education, and Economics.’’ 

Food and Drug Administration. http:// 

www.fda.gov/AboutFDA/Partnerships

Collaborations/ 

MemorandaofUnderstandingMOUs/ 

DomesticMOUs/ucm261929.htm. 

Accessed February 28, 2012. Last 

Modified 2011. 

25. ‘‘International Outreach & Technical 

Assistance.’’ Food and Drug 

Administration. http://www.fda.gov/

Food/InternationalActivities/ 

ucm103051.htm. Accessed December 9, 

2011. Last Modified 2009. 

26. Gravani, R. B. Produce Safety Project 

Issue Brief: Farm Worker Health and 

Hygiene. Georgetown University: 

Produce Safety Project, 2010. http:// 

www.pewhealth.org/uploadedFiles/PHG/

Content_Level_Pages/Issue_Briefs/ 

PSP_Worker-1.pdf. Accessed 11–29– 

2011. 

27. Erickson, M., Critzer, F., and Doyle, M. 

Issue Brief on Composting of Animal 

Manures, Composting Criteria for 

Animal Manure. 2010. http:// 

www.pewhealth.org/uploadedFiles/PHG/ 

Content_Level_Pages/Issue_Briefs/ 

PSP_PEW-PSP-Composting-ManureNarrative-v4-2.pdf. Accessed 5–25–2012. 

28. Lowell, K., Langholz, J., and Stuart, D. 

Safe and Sustainable: Co-Managing for 

Food Safety and Ecological Health in 

California’s Central Coast Region. 2010. 

http://www.pewhealth.org/

uploadedFiles/PHG/Content_

Level_Pages/Issue_Briefs/PSP_SummarySS.pdf. Accessed 12–9–2011. 

29. Suslow, T. V. Standards for Irrigation and 

Foliar Contact Water. Georgetown 

University: Produce Safety Project, 2010. 

http://www.pewhealth.org/

uploadedFiles/PHG/Content_Level

_Pages/Issue_Briefs/PSP_Water-Suslow1.pdf. Accessed 11–29–2011. 

30. ‘‘Safeway Quality Assurance and 

Consumer Protection Policy.’’ Noland, J. 

and Kunduru, M. http:// 

suppliers.safeway.com/usa/forms/ 

Produce_Vendor_Food_

Safety_Verification_Program.pdf. 

Accessed December 9, 2011. Last 

Modified 2008. 

31. ‘‘California Leafy Green Products 

Handlers Marketing Agreement.’’ 

California Department of Food and 

Agriculture. http://www.caleafygreens

.ca.gov/mission. Accessed December 9, 

2011. Last Modified 2011. 

32. ‘‘Arizona Leafy Green Products Shipper 

Marketing Agreement.’’ Arizona 

Department of Agriculture. http:// 

www.azlgma.gov/default.asp. Accessed 

December 9, 2011. Last Modified 2011. 

33. ‘‘Product Quality and Safety.’’ Wegmans. 

http://www.wegmans.com/webapp/wcs/ 

stores/servlet/

ProductDisplay?productId=

656169&storeId=10052&langId=-1. Last 

Modified 2011. 

34. Mahovic, M. and Food and Drug 

Administration, ‘‘Memorandum to the 

Record’’, 2011. 

35. Wise, C. and Food and Drug 

Administration. s.v. ‘‘Memorandum to 

the Record.’’ Accessed 2012. 

36. ‘‘National Organic Standards Board, 

Compost Tea Task Force Report.’’ 

National Organic Standards Board. 

http://www.ams.usda.gov/AMSv1.0/ 

getfile?dDocName=STELPRDC5058470. 

Accessed April 6, 2004. Last Modified 11 

A.D. 

37. ‘‘Outbreak of Salmonella Serotype 

Saintpaul Infections Associated with 

Multiple Raw Produce Items—United 

States, 2008.’’ Centers for Diseas Control 

and Prevention. MMWR Weekly. http:// 

www.cdc.gov/mmwr/preview/ 

mmwrhtml/mm5734a1.htm. Accessed 

December 14, 2011. Last Modified 2008. 

38. Penteado, A. L., Eblen, B. S., and Miller, 

A. J. ‘‘Evidence of Salmonella 

Internalization into Fresh Mangos during 

Simulated Postharvest Insect 

Disinfestation Procedures.’’ Journal of 

Food Protection 67, no. 1 (2004): 181– 

184. 

39. Yanko, W. A. s.v. ‘‘Project Summary, 

Occurence of Pathogens in Distribution 

and Marketing Municipal Sludges.’’ 

Accessed 1988. 

40. Codex Alimentarius Commission. s.v. 

‘‘Hazard Analysis and Critical Control 

Point (HACCP) System and Guidelines 

for Its Application.’’ Accessed 2003. 

www.codexalimentarius.net/download/ 

standards/23/CXP_001e.pdf. 

41. ‘‘Hazard Analysis and Critical Control 

Point Principles and Application 

Guidelines.’’ National Advisory 

Committee on Microbiological Criteria 

for Food. 

http://www.fda.gov/Food/FoodSafety/ 

HazardAnalysisCritical

ControlPointsHACCP/ucm114868.htm. 

mstockstill on DSK4VPTVN1PROD with 

3622 Federal Register / Vol. 78, No. 11 / Wednesday, January 16, 2013 / Proposed Rules 

Accessed December 14, 2011. Last 

Modified 2011. 

42. Food and Drug Administration. 

Quantitative Risk Assessment to Support 

the Proposed Produce Rule. 2012. 

43. ‘‘Commodity Specific Food Safety 

Guidelines for the Melon Supply Chain.’’ 

Produce Industry Food Safety Initiative, 

Produce Marketing Association, and 

United Fresh Fruit and Vegetable 

Association. http:// 

www.nationalwatermelon

association.com/MelonGuidance

Document.pdf. Accessed December 14, 

2011. Last Modified 2005. 

44. North American Tomato Trade Work 

Group and California Tomato 

Commission. Commodity Specific Food 

Safety Guidelines for the Fresh Tomato 

Supply Chain. Fresno, CA: North 

American Tomato Trade Work Group, 

2006. 

45. California Leafy Green Products Handler 

Marketing Agreement. Commodity 

Specific Food Safety Guidelines for the 

Production and Harvest of Lettuce and 

Leafy Greens. Sacramento: California 

Leafy Green Products Handler Marketing 

Agreement, 2011. http:// 

www.caleafygreens.ca.gov/food-safetypractices/downloads. Accessed 11–29– 

2011. 

46. Western Growers Association and 

Intertox Incorporated. Commodity 

Specific Food Safety Guidelines for the 

Production, Harvest, Post-Harvest, and 

Valued-Added Unit Operations of Green 

Onions. Western Growers Association; 

Intertox, Inc., 2010. http://www.fda.gov/ 

downloads/Food/FoodSafety/ProductSpecificInformation/FruitsVegetables

Juices/GuidanceCompliance

RegulatoryInformation/UCM203114.pdf. 

Accessed 11–29–2011. 

47. Food and Agriculture Organization and 

World Health Organization. CODEX 

Alimentarius Code of Hygienic Practice 

for Fresh Fruits and Vegetables. 2010. 1– 

26. 

48. United Fresh Fruit and Vegetable 

Association. s.v. ‘‘Field Operations and 

Harvesting Harmonized Food Safety 

Standard.’’ Accessed 2011. 

49. United Fresh Fruit and Vegetable 

Association. s.v. ‘‘Post-harvest 

Operations Harmonized Food Safety 

Standard.’’ Accessed 2011. 

50. Joint FAO/WHO Codex Alimentarius 

Commission, Joint FAO/WHO Food 

Standards Program, World Health 

Organization et al. Codex Alimentarius: 

Fresh Fruits and Vegetables. Rome: FAO, 

2007. 

51. ‘‘Integrated Farm Assurance (IFA) 

Standard Version 4, Fruit and 

Vegetables.’’ GLOBALG.A.P. http:// 

www.globalgap.org/cms/front_content.

php?idart=1440&changelang=1. 

Accessed December 28, 2011. Last 

Modified 2011. 

52. ‘‘Costco mandates produce testing by 

suppliers.’’ The Packer. Accessed 

December 19, 2011. Last Modified 2011. 

53. ‘‘Perishable Pundit, A Closer Look at 

Finished Product Testing.’’ Prevor Jim. 

http://www.perishablepundit.com/ 

index.php?date=09/07/07&pundit=5. 

Last Modified 2007. 

54. ‘‘Microbiological Testing of Fresh 

Produce, A White Paper on 

Considerations in Developing and Using 

Microbiological Sampling and Testing 

Procedures if Used as Part of a Food 

Safety Program for Fresh Fruit and 

Vegetable Products.’’ United Fresh Fruit 

and Vegetable Association and United 

Fresh Produce Association Food Safety & 

Technology Council. http:// 

www.unitedfresh.org/assets/food_safety/

MicroWhite_Paper.pdf. Accessed 

December 19, 2011. Last Modified 2010. 

55. Buchanan, R. L. ‘‘Acquisition of 

Microbiological Data to Enhance Food 

Safety.’’ Journal of Food Protection 63, 

no. 6 (2000): 832–838. 

56. International Commission for the 

Microbiological Specifications of Foods 

(ICMSF). ‘‘Selection and Use of 

Acceptance Criteria.’’ In Microorganisms 

in Foods 7: Microbiological Testing in 

Food Safety Management, Kluwer 

Academic/Plenum Publishers, 2002. 

57. ‘‘Investigations Operations Manual.’’ 

Food and Drug Administration. http:// 

www.fda.gov/ICECI/Inspections/IOM/

default.htm. Accessed December 14, 

2011. Last Modified 2011. 

58. ‘‘MDP-Program Data and Reports.’’ 

U.S.Department of Agriculture 

Agricultural Marketing Service. http:// 

www.ams.usda.gov/AMSv1.0/ 

ams.fetchTemplateData.do?

template=TemplateO&

topNav=&leftNav=

ScienceandLaboratories&page=

MDPProgramReports&

description=MDP+Program+Reports&

acct=microbiodataprg. Last Modified 

2011. 

59. Wells, J. M. and Butterfield, J. E. 

‘‘Salmonella Contamination Associated 

with Bacterial Soft Rot of Fresh Fruits 

and Vegetables in the Market Place.’’ 

Plant Disease 81, no. 8 (1997): 867–872. 

60. ‘‘Bad Bug Book: Foodborne Pathogenic 

Microorganisms and Natural Toxins 

Handbook.’’ Food and Drug 

Administration. http://www.fda.gov/

food/foodsafety/foodborneillness/ 

foodborneillnessfoodborne

pathogensnaturaltoxins/badbugbook/ 

default.htm. Accessed December 14, 

2011. Last Modified 2011. 

61. Merriam-WebsteOnline. s.v. ‘‘ ‘fruit,’ 

‘vegetable,’ ‘peanut,’ ‘grain,’ and 

‘prepare’.’’ Accessed 2011. http:// 

www.merriam-webster.com/. 

62. Beyer, D. M., PennState, College of 

Agricultural Sciences et al. Basic 

Procedures for Agaricus Mushroom 

Growing. 2003. 

63. U.S. Department of Agriculture and 

Agricultural Marketing Service. Example 

Commodities Covered by the Perishable 

Agricultural Commodities Act (PACA). 

USDA, 2010. http://www.ams.usda.gov/

AMSv1.0/getfile?dDoc

Name=STELPRDC5082566. Accessed 

11–30–2011. 

64. ‘‘Food Groups, Vegetables, What Foods 

Are in the Vegetable Group?’’ U.S. 

Department of Agriculture. http:// 

www.choosemyplate.gov/food-groups/ 

vegetables.html. Accessed December 14, 

11 A.D. Last Modified 2011. 

65. ‘‘Produce Facts in English, 

Recommendations for Maintaining 

Postharvest Quality.’’ University of 

California and UC Davis. http:// 

postharvest.ucdavis.edu/producefacts/. 

Accessed December 14, 2011. Last 

Modified 2011. 

66. ‘‘ProduceMarketGuide.com.’’ http:// 

www.producemarketguide.com/. 

Accessed December 14, 2011. Last 

Modified 2011. 

67. Penn State University and the American 

Mushroom Institute. Mushroom Good 

Agricultural Practices Program: IndustryWide Food Safety Standards for Fresh 

Mushroom Growing, Harvesting, and 

Shipping. 2010. https://sites.google.com/ 

a/mgap.org/mgap/home/mgap-files/

MGAP_v_15May2010.pdf?attredirects=0. 

Accessed 11–29–2011. 

68. ‘‘Good Sprout News, What Are Sprouts? 

Where Do They Come From?’’ 

International Sprout Growers 

Association. http://www.isgasprouts.org/grow.htm. Accessed 

December 14, 2011. Last Modified 2010. 

69. California Almonds, A. B. o. C. s.v. ‘‘Good 

Agricultural Practices.’’ Accessed 2011. 

70. American Peanut Council. s.v. ‘‘Good 

Agricultural Practices for Safe Growing 

and Harvesting of Peanuts.’’ 

71. U.S. Department of Agriculture, 

Agricultural Marketing Service, Fruit 

and Vegetable Programs et al. s.v. 

‘‘Directive 2020: Products Not Subject to 

the PACA.’’ Accessed 2003. 

72. ‘‘Food Groups, What Foods Are in the 

Protein Foods Group?’’ U.S. Department 

of Agriculture. http://www.choosemy

plate.gov/food-groups/proteinfoods.html. 

Accessed December 14, 2011. Last 

Modified 2011. 

73. ‘‘Food Groups, What Foods Are in the 

Grains Group?’’ U.S. Department of 

Agriculture. http://www.choosemy

plate.gov/food-groups/grains.html. 

Accessed December 14, 2011. Last 

Modified 2011. 

74. CODEX. s.v. ‘‘Code of Practice for the 

Prevention and Reduction of Mycotoxin 

Contamination in Cereals, Including 

Annexes on Ochratoxin A, Zearalenone, 

Fumonisins and Tricothecenes.’’ 

Accessed 2011. 

75. Mazzotta, A. S. ‘‘Research Note, Heat 

Resistance of Listeria monocytogenes in 

Vegetables: Evaluation of Blanching 

Process.’’ Journal of Food Protection 64, 

no. 3 (2001): 385–387. 

76. Doyle, M. E., Mazzotta, A. S., Wang, T. 

et al. ‘‘Review, Heat Resistance of 

Listeria monocytogenes.’’ Journal of 

Food Protection 64, no. 3 (2001): 410– 

429. 

77. DiPersio, P. A., Kendall, P. A., Yoon, Y. 

et al. ‘‘Influence of Blanching Treatments 

on Salmonella during Home-type 

Dehydration and Storage of Potato 

Slices.’’ Journal of Food Protection 68, 

no. 12 (2005): 2587–2593. 

78. Bari, M. L., Inatsu, Y., Isobe, S. et al. 

‘‘Research Note, Hot Water Treatments to 

Inactivate Escherichia coli O157:H7 and 

mstockstill on DSK4VPTVN1PROD with 

Federal Register / Vol. 78, No. 11 / Wednesday, January 16, 2013 / Proposed Rules 3623 

Salmonella in Mung Bean Seeds.’’ 

Journal of Food Protection 71, no. 4 

(2008): 830–834. 

79. Johanson, J. and Food and Drug 

Administration, ‘‘Memorandum to the 

Record’’, 2012. 

80. Hoelzer, K., Pouillot, R., Egan, K. et al. 

‘‘Produce Consumption in the United 

States—An Analysis of Consumption 

Frequencies, Serving Sizes, Processing 

Forms, and High-Consuming Population 

Subgroups for Microbial Risk 

Assessments.’’ Journal of Food 

Protection 75, no. 2 (2012): 328–340. 

82. Bianchini, F. and Corbetta, F. The 

Complete Book of Fruits and Vegetables. 

New York: Crown Publishers, 1976. 

83. ‘‘Guidance for Industry: Guide to 

Minimize Microbial Food Safety Hazards 

of Fresh-cut Fruits and Vegetables.’’ 

Food and Drug Administration and 

Center for Food Safety and Applied 

Nutrition. 

http://www.fda.gov/food/guidance

complianceregulatoryinformation/

guidancedocuments/produceand

planproducts/ucm064458.htm#ch8. 

Accessed November 29, 2011. Last 

Modified 2008. 

84. ‘‘Guidance for Industry: Antimicrobial 

Food Additives.’’ Food and Drug 

Administration. http://www.fda.gov/

Food/GuidanceComplianceRegulatory

Information/GuidanceDocuments/

FoodIngredientsandPackaging/

ucm077256.htm?utm_

campaign=Google2&utm_source=

fdaSearch&utm_medium=website&utm_

term=Guidance%20for%20Industry%20

Antimicrobial&utm_content=1. Accessed 

May 22, 2012. Last Modified 2011. 

85. U.S. Department of Agriculture and 

National Commission on Small Farms. A 

Time to Act. Washington, DC: USDA, 

1998. http://www.csrees.usda.gov/nea/ 

ag_systems/in_focus/smallfarms_if_

time.html. Accessed 12–1–2011. 

86. U.S. Department of Agriculture. Farms, 

Land in Farms, and Livestock Operations 

2009 Summary. USDA National 

Agricultural Statistics Service, 2010. 

http://usda01.library.cornell.edu/usda/ 

nass/FarmLandIn//2010s/2010/ 

FarmLandIn-02-12-2010_new_

format.pdf. Accessed 11–30–2011. 

87. ‘‘Draft Guidance for Industry: Testing for 

Salmonella Species in Human Foods and 

Direct-Human-Contact Animal Foods.’’ 

Food and Drug Administration. http:// 

www.fda.gov/Food/GuidanceCompliance

RegulatoryInformation/

GuidanceDocuments/FoodSafety/ucm

247759.htm. Accessed December 14, 

2011. Last Modified 2011. 

88. ‘‘Guidance for Industry: Measures to 

Address the Risks for Contamination by 

Salmonella Species in Food Containing a 

Peanut-Derived Product as an 

Ingredient.’’ Food and Drug 

Administration. http://www.fda.gov/

Food/GuidanceComplianceRegulatory

Information/GuidanceDocuments/

ProduceandPlanProducts/

ucm115386.htm. Accessed December 14, 

2011. Last Modified 2011. 

89. O’Rell, K. and National Organic 

Standards Board. Formal 

Recommendation by the National 

Organic Standards Board (NOSB) to the 

National Organic Program (NOP). 2006. 

90. State of Florida. s.v. ‘‘Criteria for Organics 

Processing and Recycling Facilities.’’ 

Accessed 2010. 

91. ‘‘Title 40—Protection of the Environment, 

Chapter I—Environmental Protection 

Agency, Subchapter O—Sewage Sludge, 

Part 503—Standards for the Use or 

Disposal of Sewage Sludge.’’ U.S. 

Environmental Protection Agency. 

http://ecfr.gpoaccess.gov/cgi/t/text/textidx?c=ecfr&sid=b5569c064fb7d288e

6f263c95242c58c&tpl=/ecfrbrowse/

Title40/40cfr503_main_02.tpl. Accessed 

December 14, 2011. Last Modified 2011. 

92. U.S. Environmental Protection Agency. 

Environmental Regulations and 

Technology, Control of Pathogens and 

Vector Attraction in Sewage Sludge. U.S. 

Environmental Protection Agency, 2003. 

93. ‘‘California Regulations: Title 14, Natural 

Resources—Division 7, CIWMB Chapter 

3.1. Compostable Materials Handling 

Operations and Facilities Regulatory 

Requirements.’’ http://www.calrecycle.

ca.gov/Laws/Regulations/Title14/

ch31.htm. Accessed May 25, 2012. Last 

Modified 2012. 

94. ‘‘Composting Fact Sheets.’’ Cornell Waste 

Management Institute. http://cwmi.css.

cornell.edu/factsheets.htm. Accessed 

December 14, 2011. Last Modified 2011. 

95. ‘‘CPG Sec. 555.750 Seeds for Sprouting 

Prior to Food Use, i.e., Dried Mung 

Beans, Alfalfa Seeds, etc.’’ Food and 

Drug Administration. http:// 

www.fda.gov/ICECI/Compliance

Manuals/CompliancePolicy

GuidanceManual/ucm074562.htm. 

Accessed December 1, 2011. Last 

Modified 1989. 

96. Joint FAO/WHO Codex Alimentarius 

Commission, Joint FAO/WHO Food 

Standards Program, UN Food and 

Agriculture Organization et al. Codex 

Alimentarius: Food Hygiene; Basic Texts. 

Rome: FAO, 2003. 

97. U.S. Department of Agriculture, N. R. C. 

S. ‘‘Composting.’’ In Part 637 

Environmental Engineering, National 

Engineering Handbook, United States 

Department of Agriculture, 2000. 

98. Whitehead, D. C. and Tinsley, J. ‘‘The 

Biochemistry of Humus Formation.’’ 

Journal of the Science of Food and 

Agriculture 14, no. 12 (1963): 849–857. 

10.1002/jsfa.2740141201. 

99. Troller, J. A. Sanitation in Food 

Processing. Academic Press, 1993. 

100. ‘‘Land and Water Discussion Paper: Onfarm composting methods.’’ Misra, R. V., 

Roy, R. N., Hiraoka et al. ftp:// 

ftp.fao.org/docrep/fao/006/y5104e/y

5104e00.pdf. Accessed December 19, 

2011. Last Modified 2003. 

101. ‘‘Ohio State University Extension Fact 

Sheet, Ground- and Surface-Water 

Terminology.’’ Brown, L. C. and Black, L. 

P. http://ohioline.osu.edu/aex-fact/

0460.html. Accessed December 19, 2011. 

Last Modified 2011. 

102. ‘‘The Census of Agriculture, 2007 

Census of Agriculture.’’ U.S. Department 

of Agriculture. http://www.agcensus.

usda.gov/publications/2007/index.asp. 

Accessed December 19, 2011. Last 

Modified 2011. 

103. ‘‘Guidance for Industry: Questions and 

Answers Regarding the Labeling of 

Dietary Supplements as Required by the 

Dietary Supplement and 

Nonprescription Drug Consumer 

Protection Act.’’ Food and Drug 

Administration. http://www.fda.gov/ 

Food/GuidanceCompliance

RegulatoryInformation/

GuidanceDocuments/Dietary

Supplements/ucm179018.htm. Accessed 

December 14, 2011. Last Modified 2011. 

104. Islam, M., Doyle, M. P., Phatak, S. C. et 

al. ‘‘Persistence of Enterohemorrhagic 

Escherichia coli O157:H7 in Soil and on 

Leaf Lettuce and Parsley Grown in Fields 

Treated with Contaminated Manure 

Composts or Irrigation Water.’’ Journal of 

Food Protection 67, no. 7 (2004): 1365– 

1370. 

105. ‘‘National GAPs Educational Materials.’’ 

Cornell University, D. o. F. S. http:// 

www.gaps.cornell.edu/educational

materials.html. Accessed December 19, 

2011. Last Modified 2011. 

106. Well, J. M. and Butterfield, J. E. 

‘‘Incidence of Salmonella on Fresh Fruits 

and Vegetables Affected by Fungal Rots 

or Physical Injury.’’ Plant Disease 83, no. 

8 (1999): 722–726. 

107. Michaels, B. S. and Todd, E. C. D. 

‘‘Microbial Hazard Identification in 

Fresh Fruits and Vegetables.’’ In 

Microbial hazard identification in fresh 

fruits and vegetables., edited by James, 

Jennylynd, 115- Hoboken, NJ: John Wiley 

& Sons, Inc., 2006. 10.1002/0470007761. 

108. Smith, D. L., Stableforth, D. E., and 

Smith, E. G. ‘‘Case Reports, Salmonella 

newport in the sputum of a patient with 

cystic fibrosis.’’ Respiratory Medicine 87, 

(1993): 625–627. 

109. Porter, J. D., Gaffney, C., Heymann, D. 

et al. ‘‘Food-Borne Outbreak of Giardia 

lamblia.’’ American Journal of Public 

Health 80, no. 10 (1990): 1259–1260. 

110. Todd, E. C. D., Michaels, B. S., Smith, 

D. et al. ‘‘Outbreaks Where Food 

Workers Have Been Implicated in the 

Spread of Foodborne Disease. Part 9. 

Washing and Drying of Hands to Reduce 

Microbial Contamination.’’ Journal of 

Food Protection 73, no. 10 (2010): 1937– 

1955. 

111. National Association of State Public 

Health Veterinarians. ‘‘Compendium of 

Measures to Prevent Disease Associated 

with Animals in Public Settings, 2011.’’ 

MMWR Weekly 60, no. 4 (2011): 

112. Patrick, D. R., Findon, G., and Miller, T. 

E. ‘‘Residual Moisture Determines the 

Level of Touch-Contact-Associated 

Bacterial Transfer Following Hand 

Washing.’’ Epidemiology and Infection 

119, no. 3 (1997): 319–325. 

113. Todd, E. C. D., Michael, B. S., Holah, J. 

et al. ‘‘Outbreaks Where Food Workers 

Have Been Implicated in the Spread of 

Foodborne Disease. Part 10. AlcoholBased Antiseptics for Hand Disinfection 

and a Comparison of Their Effectiveness 

with Soaps.’’ Journal of Food Protection 

73, no. 11 (2010): 2128–2140. 

mstockstill on DSK4VPTVN1PROD with 

3624 Federal Register / Vol. 78, No. 11 / Wednesday, January 16, 2013 / Proposed Rules 

114. Todd, E. C. D., Michaels, B. S., Greig, 

J. D. et al. ‘‘Outbreaks Where Food 

Workers Have Been Implicated in the 

Spread of Foodborne Disease. Part 8. 

Gloves as Barriers to Prevent 

Contamination of Food by Workers.’’ 

Journal of Food Protection 73, no. 9 

(2010): 1762–73. 

115. Food and Drug Administration and 

Mahovic, M., ‘‘Memorandum to the 

Record’’, 2011. 

116. Edberg, S. C., Rice, E. W., Karlin, R. J. 

et al. ‘‘Escherichia coli: the best 

biological drinking water indicator for 

public health protection.’’ Journal of 

Applied Microbiology 88, (2000): 106S– 

116S. 

117. Song, I., Stine, S. W., Choi, C. Y. et al. 

‘‘Comparison of Crop Contamination by 

Microorganisms during Subsurface Drip 

and Furrow Irrigation.’’ Journal of 

Environmental Engineering 132, no. 10 

(2006): 1243–1248. 

118. World Health Organization and United 

Nations Environmental Programs. WHO 

Guidelines for the Safe Use of 

Wastewater, Excreta and Greywater. 

Geneva, Switzerland: WHO Press, 2006. 

119. Tallon, P., Magajna, B., Lofranco, C. et 

al. ‘‘Microbial Indicators of Faecal 

Contamination in Water: A Current 

Perspective.’’ Water, Air, & Soil Pollution 

166, no. 1–4 (2005): 139–166. 10.1007/ 

s11270–005–7905–4. 

120. Gerba, C. P. ‘‘The Role of Water and 

Water Testing in Produce Safety.’’ In 

Microbial Safety of Fresh Produce, edited 

by Fan, X., Niemira, B. A., Doona, C. J., 

Feeherry, F. E., and Gravani, R. B., 129– 

142. Ames, IA: Wiley-Blackwell, 2009. 

121. ‘‘What You Should Know About 

Irrigation Water Quality Safety.’’ 

Jamieson, T., Gordon, R., Bezanson, G. S. 

et al. 

http://nsac.ca/eng/outreach/Irrigation

waterquality.pdf. Last Modified 2002. 

122. Leifert, C., Ball, K., Volakakis, N. et al. 

‘‘Control of Enteric Pathogens in Readyto-Eat Vegetable Crops in Organic and 

‘Low Input’ Production Systems: a 

HACCP-Based Approach.’’ Journal of 

Applied Microbiology 105, no. 4 (2008): 

931–950. 

123. Committee on Indicators for Waterborne 

Pathogens, N. R. C. Indicators for 

Waterborne Pathogens. Washington, DC: 

National Academies Press, 2004. http:// 

www.nap.edu/catalog.php?record_id=

11010#toc. 

124. Leclerc, H., Mossel, D. A. A., Edberg, S. 

C. et al. ‘‘Advances in the Bacteriology 

of the Coliform Group: Their Suitability 

as Markers of Microbial Water Safety.’’ 

Annual Review of Microbiology 55, 

(2001): 201–234. 

125. Seyfried, P. and Harris, E. 

Bacteriological Characterization of Feces 

and Source Differentiation. Queen’s 

Printer for Ontario, 1990. 

126. Carrillo, M., Estrada, E., and Hazen, T. 

C. ‘‘Survival and Enumeration of the 

Fecal Indicators Bifidobacterium 

adolescentis and Escherichia coli in a 

Tropical Rain Forest Watershed.’’ 

Applied and Environmental 

Microbiology 50, no. 2 (1985): 468–476. 

127. Gauthier, F. and Archibald, F. ‘‘The 

Ecology of ‘Fecal Indicator Bacteria’ 

Commonly Found in Pulp and Paper 

Mill Water Systems.’’ Water Research 35, 

no. 9 (2001): 2207–2218. doi: 10.1016/ 

S0043–1354(00)00506–6. 

128. Garzio-Hadzick, A., Shelton, D. R., Hill, 

R. L. et al. ‘‘Survival of Manure-Borne E. 

coli in Streambed Sediment: Effects of 

Temperature and Sediment Properties.’’ 

Water Research 44, no. 9 (2010): 2753– 

62. 

129. Whitman, R. L., Nevers, M. B., PrzybylaKelly, K. et al. ‘‘Physical and Biological 

Factors Influencing Environmental 

Sources of Fecal Indicator Bacteria in 

Surface Water.’’ In The Fecal Bacteria, 

edited by Sadowsky, Michael J. and 

Whitman, Richard L., 111–134. 

American Society for Microbiology 

(ASM), 2011. 

130. McElhany, K. G. and Pillai, S. D. 

‘‘Prevalence and Fate of Gut-Associated 

Human Pathogens in the Environment.’’ 

In Fecal Bacteria, edited by Sadowsky, 

Michael J. and Whitman, Richard L., 

217–240. American Society for 

Microbiology (ASM), 2011. 

131. Horman, A., Rimhanen-Finne, R., 

Maunula, L. et al. ‘‘Campylobacter spp., 

Giardia spp., Cryptosporidium spp., 

Noroviruses and Indicator Organisms in 

Surface Water in Southwestern Finland, 

2000–2001.’’ Applied and Environmental 

Microbiology 70, no. 1 (2004): 87–95. 

132. Duris, J. W., Haack, S. K., and Fogarty, 

L. R. ‘‘Gene and Antigen Markers of 

Shiga-Toxin Producing E. coli from 

Michigan and Indiana River Water: 

Occurrence and Relation to Recreational 

Water Quality Criteria.’’ Journal of 

Environmental Quality 38, no. 5 (2009): 

1878–1886. 

133. Wilkes, G., Edge, T., Gannon, V. et al. 

‘‘Seasonal Relationships among Indicator 

Bacteria, Pathogenic Bacteria, 

Cryptosporidium Oocysts, Giardia Cysts, 

and Hydrological Indices for Surface 

Waters within an Agricultural 

Landscape.’’ Water Research 43, no. 8 

(2009): 2209–2223. 

134. Diez-Gonzalez. ‘‘Fecal Bacteria and 

Foods.’’ In Fecal Bacteria, edited by 

Sadowsky, Michael J. and Whitman, 

Richard L., 275–293. American Society 

for Microbiology (ASM), 2011. 

135. Garrett, E. H. ‘‘Plant Sanitation and 

Good Manufacturing Practices for 

Optimum Food Safety in Fresh-Cut 

Produce.’’ In Microbial Safety of Fresh 

Produce, edited by Fan, Xuetong, 

Niemira, Brendan A., Doona, Christopher 

J. Feeherry Forence E., and Gravani, 

Robert B., 307–320. Oxford, UK: WileyBlackwell, 2009. 10.1002/ 

9781444319347.ch16. 

136. United States Environmental Protection 

Agency. Ambient Water Quality Criteria 

for Bacteria—1986. 1986. 

137. ‘‘Water Quality Criteria for 

Microbiological Indicators: Overview 

Report.’’ Johnson, T. R. http:// 

www.env.gov.bc.ca/wat/wq/ 

BCguidelines/microbiology/ 

microbiology.html#tab1. Accessed 

November 29, 2011. Last Modified 2001. 

138. Bartz, J. A. and Showalter, R. K. 

‘‘Infiltration of Tomatoes by Aqueous 

Bacterial Suspensions.’’ Phytopathology 

71, no. 5 (1981): 515–518. 

139. Bartz, J. A. ‘‘Potential for Postharvest 

Disease in Tomato Fruit Infiltrated with 

Chlorinated Water.’’ Plant Disease 72, 

no. 1 (1988): 9–13. 

140. Xia, X., Luo, Y., Yang, Y. et al. ‘‘Effects 

of Tomato Variety, Temperature 

Differential, and Post-Stem Removal 

Time on Internalization of Salmonella 

enterica Serovar Thompson in 

Tomatoes.’’ Journal of Food Protection 

(2011): 

141. Steele, M. and Odumeru, J. ‘‘Irrigation 

Water as Source of Foodborne Pathogens 

on Fruit and Vegetables.’’ Journal of 

Food Protection 67, no. 12 (2004): 2839– 

2849. 

142. Ingram, D. and Millner, P. ‘‘Factors 

affecting compost tea as a potential 

source of Escherichia Coli and 

Salmonella on fresh produce.’’ Journal of 

Food Protection 70, no. 4 (2007): 828– 

834. 

143. Howell, J. M., Coyne, M. S., and 

Cornelius, P. ‘‘Water Quality, Fecal 

Bacteria in Agricultural Waters of the 

Bluegrass Region of Kentucky.’’ Journal 

of Environmental Quality 24, (1995): 

415–419. 

144. Close, M., Dann, R., Ball, A. et al. 

‘‘Microbial Groundwater Quality and its 

Health Implications for a Border-Strip 

Irrigated Dairy Farm Catchment, South 

Island, New Zealand.’’ Journal of Water 

and Health 6, no. 1 (2008): 83–98. 

145. Mai, T. L., Sofyan, N. I., Fergus, J. W. 

et al. ‘‘Attachment of Listeria 

monocytogenes to an Austenitic 

Stainless Steel after Welding and 

Accelerated Corrosion Treatments.’’ 

Journal of Food Protection 69, no. 7 

(2006): 1527–1532. 

146. Reynolds, K. A., Mena, K. D., and Gerba, 

C. P. ‘‘Risk of Waterborne Illness via 

Drinking Water in the United States.’’ 

Reviews of Environmental 

Contamination and Toxicology 192, 

(2008): 117–158. 

147. Westrell, T., Bergstedt, O., Stenstrom, T. 

A. et al. ‘‘A theoretical approach to 

assess microbial risks due to failures in 

drinking water systems.’’ International 

Journal of Environmental Health 

Research 13, (2003): 181–197. 10.1080/ 

0960312031000098080. 

148. Food and Drug Administration and 

Snellman, E., ‘‘Memorandum to the 

Record’’, 2011. 

149. Suslow, T. V. and University of 

California. Postharvest Chlorination: 

Basic Properties and Key Points for 

Effective Disinfection. Oakland, CA: 

University of California, Division of 

Agriculture and Natural Resources, 1997. 

150. Suslow, T. V. Water Disinfection: A 

practical Approach to Calculating Dose 

Values for Preharvest and Postharvest 

Applications. UC Davis: Agriculture and 

Natural Resources, 2001. http:// 

anrcatalog.ucdavis.edu/pdf/7256.pdf. 

Accessed 11–29–2011. 

151. McLellan, S. L., Daniels, A. D., and 

Salmore, A. K. ‘‘Clonal Populations of 

mstockstill on DSK4VPTVN1PROD with 

Federal Register / Vol. 78, No. 11 / Wednesday, January 16, 2013 / Proposed Rules 3625 

Thermotolerant Enterobacteriaceae in 

Recreational Water and Their Potential 

Interference with Fecal Escherichia coli 

Counts.’’ Applied and Environmental 

Microbiology 67, no. 10 (2001): 4934– 

4938. 

152. Jjemba, P. K., Weinrich, L. A., Cheng, W. 

et al. ‘‘Regrowth of Potential 

Opportunistic Pathogens and Algae in 

Reclaimed-Water Distribution Systems.’’ 

Applied and Environmental 

Microbiology 76, no. 13 (2010): 4169– 

4178. 

153. Cooley, M., Carychao, D., CrawfordMiksza, L. et al. ‘‘Incidence and Tracking 

of Escherichia coli O157:H7 in a Major 

Produce Prodution Region in California.’’ 

PLoS ONE 11, no. e1159 (2007): 

154. Pachepsky, Y. A. and Shelton, D. R. 

‘‘Escherichia Coli and Fecal Coliforms in 

Freshwater and Estuarine Sediments.’’ 

Critical Reviews in Environmental 

Science and Technology 41, no. 12 

(2011): 1067–1110. 

155. Wade, T. J., Sams, E., Brenner, K. P. et 

al. ‘‘Rapidly measured indicators of 

recreational water quality and 

swimming-associated illness at marine 

beaches: A prospectie cohort study.’’ 

Environmental Health 9, (2010): 

156. Pruss, A. ‘‘Review of epidemiological 

studies on health effects from exposure 

to recreational water.’’ International 

Journal of Epidemiology 27, (1988): 1–9. 

157. Droppo, I. G., Krishnappan, B. G., Liss, 

S. N. et al. ‘‘Modelling SedimentMicrobial Dynamics in the South Nation 

River, Ontario, Canada: Towards the 

Prediction of Aquatic and Human Health 

Risk.’’ Water Research 45, no. 12 (2011): 

3797–3809. doi: 10.1016/ 

j.watres.2011.04.032. 

158. Haley, B. J., Cole, D. J., and Lipp, E. K. 

‘‘Distribution, Diversity, and Seasonality 

of Waterborne Salmonellae in a Rural 

Watershed.’’ Applied and Environmental 

Microbiology 75, no. 5 (2009): 1248– 

1255. 

159. Lipp, E. K., Kurz, R., Vincent, R. et al. 

‘‘The Effects of Seasonal Variability and 

Weather on Microbial Fecal Pollution 

and Enteric Pathogens in a Subtropical 

Estuary.’’ Estuaries 24, no. 2 (2001): 266– 

276. 

160. Buchanan, R. L., Edelson, S. G., Miller, 

R. L. et al. ‘‘Contamination of Intact 

Apples after Immersion in an Aqueous 

Environment Containing Escherichia coli 

O157:H7.’’ Journal of Food Protection 62, 

no. 5 (1999): 444–450. 

161. ‘‘Preliminary Experiments on the Effect 

of Temperature Differences on Dye 

Uptake by Oranges and Grapefruit.’’ 

Merker, R., Edelson-Mammel, S., Davis, 

V. et al. FDA. http://www.fda.gov/Food/ 

FoodSafety/HazardAnalysis

CriticalControlPointsHACCP/

JuiceHACCP/ucm082931.htm. Accessed 

December 1, 2011. Last Modified 1999. 

162. Sivapalasingam, S., Barrett, E., Kimura, 

A. et al. ‘‘A Multistate Outbreak of 

Salmonella enterica Serotype Newport 

Infection Linked to Mango Consumption: 

Impact of Water-Dip Disinfestation 

Technology.’’ Clinical Infectious 

Diseases 37, no. 12 (2003): 1585–1590. 

163. Ohio. s.v. ‘‘Standards for compost 

products.’’ Accessed 2004. 

164. ‘‘Chapter 3.1 Compostable Materials 

Handling Operations and Facilities 

Regulatory Requirments.’’ California. 

http://www.calrecycle.ca.gov/Laws/ 

Regulations/Title14/ch31.htm. Accessed 

December 19, 2011. Last Modified 2011. 

165. Jones, P. and Martin, M. s.v. ‘‘A Review 

of the Literature on the Occurence and 

Surival of Pathogens of Animals and 

Humans in Green Compost.’’ Accessed 

2003. 

166. Fischer, J. R., Zhao, T., Doyle, M. et al. 

‘‘Experimental and Field Stuides of 

Escherichia coli O157:H7 in WhiteTailed Deer.’’ Applied and 

Environmental Microbiology 67, no. 3 

(2001): 1218–1224. 

167. E & A Environmental Consultants. s.v. 

‘‘Excerpts from the Document: ‘‘Research 

Concerning Human Pathogens and 

Environmental Issues Related to 

Composting of Non-Green Feedstocks’’.’’ 

Accessed 2001. 

168. Shepherd Jr., M. W., Singh, R., Kim, J. 

et al. ‘‘Effect of heat-shock treatment on 

the survival of Escherichia coli O157:H7 

and Salmonella enterica Typhimurium 

in dairy manure co-composted with 

vegetable wastes under field conditions.’’ 

Bioresource Technology 101, (2010): 

5407–5413. 

169. Renter, D. G. and Sargeant, J. M. 

‘‘Enterohemorrhagic Escherichia coli 

O157:H7 epidemiology and ecology in 

bovine production environments.’’ 

Animal Health Research Reviews 3, no. 

2 (2002): 83–94. 10.1079/AHRR200245. 

170. Yan, T. and Sadowsky Michael J. 

‘‘Determining Sources of Fecal Bacteria 

in Waterways.’’ Environ Monit Assess 

129, no. 97 (2007): 196–10.1007/s10661– 

006–9426–z. 

171. Kim, S.-H. and Wei, C.-I. ‘‘Molecular 

Characterization of Biofilm Formation 

and Attachment of Salmonella enterica 

Serovar Typhimurium DT104 on Food 

Contact Surfaces.’’ Journal of Food 

Protection 72, no. 9 (2009): 1841–1847. 

172. Ngodigha, E. M. and Owen, O. J. ‘‘Short 

Communication, Evaluation of the 

bacteriological characteristics of poultry 

litter as feedstuff for cattle.’’ Scientific 

Research and Essay 4, no. 3 (2009): 188– 

190. 

173. ‘‘Inspections, Compliance, Enforcement 

and Criminal Investigations, Tiny Greens 

5/5/11.’’ MacIntire, S. and Food and 

Drug Administration. http:// 

www.fda.gov/ICECI/ 

EnforcementActions/WarningLetters/

ucm256991.htm. Accessed December 15, 

2011. Last Modified 2011. 

174. Wichuk, K. M. and McCartney, D. ‘‘A 

review of the effectiveness of current 

time-temperature regulations on 

pathogen inactivation during 

composting.’’ Journal of Environmental 

Engineering Science 6, (2007): 573–586. 

10.1139/S07–011. 

175. Sidhu, J., Gibbs, R. A., Ho, G. E. et al. 

‘‘The Role of Indigenous Microorganisms 

in Suppression of Salmonella Regrowth 

in Composted Biosolids.’’ Water 

Research 35, no. 4 (2001): 913–920. 

176. Pell, A. N. ‘‘Manure and Microbes: 

Public and Animal Health Problem?’’ 

Journal of Dairy Science 80, (1997): 

2673–2681. 

177. Kudva, I. T., Blanch, K., and Hovde, C. 

J. ‘‘Analysis of Escherichia coli O157:H7 

Survival in Ovine or Bovine Manure and 

Manure Slurry.’’ Applied and 

Environmental Microbiology 64, no. 9 

(1998): 3166–3174. 

178. Jones, P. W. s.v. ‘‘Sewage Sludge as a 

Vector of Salmonellosis.’’ Accessed 

1986. 

179. Islam, M., Doyle, M. P., Phatak, S. C. et 

al. ‘‘Survival of Escherichia coli O157:H7 

in soil and on carrots and onions grown 

in fields treated with contaminated 

manure composts or irrigation water.’’ 

Food Microbiology 22, (2005): 63–70. 

180. You, Y., Rankin, S. C., Aceto, H. W. et 

al. ‘‘Survival of Salmonella enterica 

Serovar Newport in Manure and ManureAmended Soils.’’ Applied and 

Environmental Microbiology 72, no. 9 

(2006): 5777–5783. 

181. Himathongkham, S. and Riemann, H. 

‘‘Destruction of Salmonella 

typhimurium, Escherichia coli O157:H7 

and Listeria monocytogenes in chicken 

manure by drying and/or gassing with 

ammonia.’’ FEMS Microbiology Letters 

171, (1999): 179–182. 

182. Martens, W. and Bohm, R. ‘‘Overview of 

the ability of different treatment methods 

for liquid and solid manure to inactivate 

pathogens.’’ Bioresource Technology 

100, (2009): 5374–5378. 

183. Weil, J. D., Beelman, R. B., and LaBorde, 

L. F. s.v. ‘‘Destruction of Select Human 

Pathogenic Bacteria in Mushroom 

Compost During Phase II 

Pasteurization.’’ Accessed 2004. 

184. Millner, P. D., ‘‘HACCP Compost for 

Fruit and Vegetable Production’’, 2009. 

185. US Composting Council. Field Guide to 

Compost Use. 2011. 

186. Brinton, Jr. W. F., Storms, P., and 

Blewett, T. C. ‘‘Occurence and Levels of 

Fecal Indicators and Pathogenic Bacteria 

in Market-Ready Recycled Organic 

Matter Composts.’’ Journal of Food 

Protection 72, no. 2 (2009): 332–339. 

187. Finstein, M. S. and Morris, M. 

‘‘Microbiology of municipal solid waste 

composting.’’ Advanced Applied 

Microbiology 19, (1975): 113–151. 

188. Suslow, T. V., Oria, M. P., Beuchat, L. 

R. et al. ‘‘Production Practices as Risk 

Factors in Microbial Food Safety of Fresh 

and Fresh-Cut Produce.’’ Comprehensive 

Review in Food Science and Food Safety 

2, (2003): 38–77. 10.1111/j.1541– 

4337.2003.tb00030.x. 

189. Diez-Gonzalez, F., Callway, T. R., 

Kizoulis, M. G. et al. ‘‘Grain Feeding and 

the Dissemination of Acid-Resistant 

Escherichia coli from Cattle.’’ Science 

281, (1998): 

190. Sorber, C. A. and Moore, B. W. s.v. 

‘‘Project Summary, Survival and 

Transport of Pathogens in SludgeAmended Soil: A Critical Literature 

Review.’’ Accessed 1987. 

191. Jiang, X., Morgan, J., and Doyle, M. P. 

‘‘Fate of Escherichia Coli O157:H7 in 

Manure-Amended Soil.’’ Applied and 

mstockstill on DSK4VPTVN1PROD with 

3626 Federal Register / Vol. 78, No. 11 / Wednesday, January 16, 2013 / Proposed Rules 

Environmental Microbiology 68, no. 5 

(2002): 2605–2609. 

192. Islam, M., Morgan, J., Doyle, M. P. et al. 

‘‘Persistence of Salmonella enterica 

Serovar Typhimurium on Lettuce and 

Parsley and in Soils on Which They were 

Grown in Fields Treated with 

Contaminated Manure Composts or 

Irrigation Water.’’ Foodborne Pathogens 

and Disease 1, no. 1 (2004): 27–35. 

193. Peng, X., Murphy, T., and Holden, N. M. 

‘‘Evaluation of the Effect of Temperature 

on the Die-Off Rate for Cryptosporidium 

parvum Oocysts in Water, Soils, and 

Feces.’’ Applied and Environmental 

Microbiology 74, no. 23 (2008): 7101– 

7107. 

194. Semenov, A. V., van Brugen, A. H., van 

Overbeek, L. et al. ‘‘Influence of 

temperature fluctuations on Escherichia 

coli O157:H7 and Salmonella enterica 

serovar Typhimurium in cow manure.’’ 

FEMS Microbiology Ecology 60, no. 3 

(2007): 419–428. 

195. Nicholson, F. A., Groves, S. J., and 

Chambers, B. J. ‘‘Pathogen survival 

during livestock manure storage and 

following land application.’’ Bioresource 

Technology 96, no. 2 (2005): 134–143. 

196. Placha, I., Venglovsky, J., Sasakova, N. 

et al. ‘‘The effect of summer and winter 

seasons on the survival of Salmonella 

typhimurium and indicator microorganisms during storage of solid 

fraction of pig slurry.’’ Journal of 

Applied Microbiology 91, no. 6 (2001): 

1036–1043. 

197. Natvig, E. E., Ingham, S. C., Ingham, B. 

H. et al. ‘‘Salmonella enterica Serovar 

Typhimurium and Escherichia coli 

Contamination of Root and Leaf 

Vegetables Grown in Soils with 

Incorporated Bovine Manure.’’ Applied 

and Environmental Microbiology 68, no. 

6 (2002): 2737–2744. 

198. Wang, G. Z. T. and Doyle, M. P. ‘‘Fate 

of Enterohemorrhagic Escherichia coli 

O157:H7 in Bovine Feces.’’ Applied and 

Environmental Microbiology 62, no. 7 

(1996): 2567–2570. 

199. Resource Conservation District of 

Monterey County. Handbook of 

Agricultural Conservation Practices, 

Photos and Descriptions with Food 

Safety Considerations. Resource 

Conservation District of Monterey 

County, 2009. 

200. Franz, E. and van Bruggen, A. H. C. 

‘‘Ecology of E. coli O157:H7 and 

Salmonella enterica in the Primary 

Vegetable Production Chain.’’ Critical 

Reviews in Microbiology 34, no. 3 (2008): 

143–161. 

201. Whipp, S. C. ‘‘Animals as a source of 

Escherichia coli pathogenic for humanbeings.’’ Journal of the American 

Medical Association 204, no. 8 (1994): 

1168–1175. 

202. Atwill, E. R., Partyka, M., Bond, R. F. 

et al. An Introduction to Waterborne 

Pathogens in Agricultural Watersheds. 

Washington, DC: USDA, Natural 

Resources Conservation Service, 2010. 

1–139. 

203. Nielsen, E. M., Skov, M. N., Madsen, J. 

J. et al. ‘‘Verocytotoxin-Producing 

Escherichia coli in Wild Birds and 

Rodents in Close Proximity to Farms.’’ 

Applied and Environmental 

Microbiology 70, no. 11 (2004): 6944– 

6947. 

204. Brackett, R. E. ‘‘Incidence, Contributing 

Factors, and Control of Bacterial 

Pathogens in Produce.’’ Postharvest 

Biology and Technology 15, no. 3 (1999): 

305–311. 

205. Francis, G. A., Thomas, C., and 

O’Beirne, D. ‘‘The Microbiological Safety 

of Minimally Processed Vegetables.’’ 

International Journal of Food Science 

and Technology 34, no. 1 (1999): 1–22. 

206. Beuchat, L. R. ‘‘Pathogenic 

Microorganisms Associated with Fresh 

Produce.’’ Journal of Food Protection 59, 

no. 2 (1996): 204–216. 

207. Tompkin, R. B., Scott, V. N., Bernard, D. 

T. et al. ‘‘Guidelines to Prevent PostProcessing Contamination from Listeria 

monocytogenes.’’ Dairy, Food and 

Environmental Sanitation: a Publication 

of the International Association of Milk, 

Food and Environmental Sanitarians 19, 

no. 8 (1999): 551–562. 

208. De Roever, C. D. ‘‘Microbiological safety 

evaluations and recommendations on 

fresh produce.’’ Food Control 9, no. 6 

(1988): 321–347. 

209. Lynch, M. F., Tauxe, R. V., and Hedberg, 

C. W. ‘‘The Growing Burden of 

Foodborne Outbreaks Due to 

Contaminated Fresh Produce: Risks and 

Opportunities.’’ Epidemiology and 

Infection 137, no. 3 (2009): 307–315. 

210. Beuchat, L. R. ‘‘Survival of 

Enterohemorrhagic Escherichia coli 

O157:H7 in Bovine Feces Applied to 

Lettuce and the Effectiveness of 

Chlorinated Water as a Disinfectant.’’ 

Journal of Food Protection 62, no. 8 

(1999): 845–849. 

211. ‘‘Surface Decontamination of Fruits and 

Vegetables Eaten Raw: A Review.’’ 

Beuchat, L. R. World Health 

Organization. http://www.who.int/ 

foodsafety/publications/fs_management/ 

surfac_decon/en/. Accessed November 

28, 2011. Last Modified 1998. 

212. Seo, K. H. and Frank, J. F. ‘‘Attachment 

of Escherichia coli O157:H7 to Lettuce 

Leaf Surface and Bacterial Viability in 

Response to Chlorine Treatment as 

Demonstrated by Using Confocal 

Scanning Laser Microscopy.’’ Journal of 

Food Protection 62, no. 1 (1999): 3–9. 

213. Brackett, R. E. ‘‘Microbiological 

consequences of minimally processed 

fruits and vegetables.’’ Journal of Food 

Quality 10, (1987): 195–206. 

214. Zhuang, R. Y., Beuchat, L. R., and 

Angulo, F. J. ‘‘Fate of Salmonella 

montevideo on and in Raw Tomatoes as 

Affected by Temperature and Treatment 

with Chlorine.’’ Applied and 

Environmental Microbiology 61, no. 6 

(1995): 2127–2131. 

215. Riordan, D. C. R., Sapers, G. M., 

Hankinson, T. R. et al. ‘‘A Study of U.S. 

Orchards to Identify Potential Sources of 

Escherichia coli O157:H7.’’ Journal of 

Food Protection 64, no. 9 (2001): 1320– 

1327. 

216. Duffy, S. and Schaffner, D. W. ‘‘Monte 

Carlo simulation of the risk of 

contaminaiton of apples with 

Escherichia coli O157:H7.’’ International 

Journal of Food Microbiology 78, (2002): 

245–255. 

217. Aruscavage, D., Lee, K., Miller, S. et al. 

‘‘Interactions Affecting the Proliferation 

and Control of Human Pathogens on 

Edible Plants.’’ Journal of Food Science 

71, no. 8 (2006): R89–R99. 10.1111/ 

j.1750-3841.2006.00157.x. 

218. Aruscavage, D., Miller, S., Lewis Ivy, M. 

L. et al. ‘‘Survival and Dissemination of 

Escherichia coli O157:H7 on Physically 

and Biologically Damaged Lettuce 

Plants.’’ Journal of Food Protection 71, 

no. 12 (2008): 2384–2388. 

219. Sargent, S. A., Brecht, J. K., Zoellner, J. 

J. et al. ‘‘Reducing Mechanical Damage to 

Tomatoes During Handling and 

Shipment’’. Paper No. 89–6616, AN 

ASAE MEETING PRESENTATION. 1989. 

220. ‘‘Guidance for Industry: Juice HACCP 

Hazards and Controls Guidance First 

Edition; Final Guidance.’’ Food and Drug 

Adminstration. http://www.fda.gov/

Food/GuidanceCompliance

RegulatoryInformation/Guidance

Documents/Juice/ucm072557.htm. 

Accessed December 22, 2011. Last 

Modified 2004. 

221. ‘‘GMPs—Appendix A: Annotated 

Bibliography on Food Safety Problems 

and Recommended Controls.’’ Food and 

Drug Administration. http:// 

www.fda.gov/Food/

GuidanceComplianceRegulatory

Information/CurrentGood

ManufacturingPracticesCGMPs/ 

ucm110962.htm. Accessed December 22, 

2011. Last Modified 2009. 

222. Sugiyama, H. and Yang, K. H. ‘‘Growth 

Potential of Clostridium botulinum in 

Fresh Mushrooms Packaged in 

Semipermeable Plastic Film.’’ Applied 

Microbiology 30, no. 6 (1975): 964–969. 

223. Austin, J. W., Dodds, K. L., Blanchfield, 

B. et al. ‘‘Growth and Toxin Production 

by Clostridium botulinum on Inoculated 

Fresh-Cut Packaged Vegetables.’’ Journal 

of Food Protection 61, no. 3 (1998): 324– 

328. 

224. Farber, J. N., Harris, L. J., Parish, M. E. 

et al. ‘‘Chapter IV, Microbiological Safety 

of Controlled and Modified Atmosphere 

Packaging of Fresh and Fresh-Cut 

Produce.’’ Comprehensive Reviews in 

Food Science and Food Safety 2 

(Supplement), (2003): 143–160. 

225. ‘‘Health Canada Advisory Concerning 

the Packaging of Fresh Mushrooms.’’ 

Health Products and Food Branch. 

http://www.hc-sc.gc.ca/fn-an/advisoriesavis/mushrooms-champignons-050817- 

eng.php. Accessed November 29, 2011. 

Last Modified 2008. 

226. Abadias, M., Canamas, T. P., Anguera, 

A. M. et al. ‘‘Microbial quality of 

commercial ‘Golden Delicious’ apples 

throughout production and shelf-life in 

Lleida (Catalonia, Spain).’’ International 

Journal of Food Microbiology 108, 

(2006): 404–409. 

227. Gagliardi, J. V., Millner, P. D., Lester, G. 

et al. ‘‘On-Farm and Postharvest 

Processing Sources of Bacterial 

Contamination to Melon Rinds.’’ Journal 

mstockstill on DSK4VPTVN1PROD with 

Federal Register / Vol. 78, No. 11 / Wednesday, January 16, 2013 / Proposed Rules 3627 

of Food Protection 66, no. 1 (2003): 82– 

87. 

228. Duffy, E. A., Lucia, L. M., Kells, J. M. 

et al. ‘‘Concentrations of Escherichia coli 

and Genetic Diversity and Antibiotic 

Resistance Profiling of Salmonella 

Isolated from Irrigation Water, Packing 

Shed Equipment, and Fresh Produce in 

Texas.’’ Journal of Food Protection 68, 

no. 1 (2005): 70–79. 

229. Taormina, P. J., Beuchat, L. R., Erickson, 

M. C. et al. ‘‘Transfer of Escherichia coli 

O157:H7 to Iceberg Lettuce via 

Simulated Field Coring.’’ Journal of Food 

Protection 72, no. 3 (2009): 465–472. 

230. Zhou, B., Luo, Y., Millner, P. et al. 

‘‘Research Note, Sanitation and Design of 

Lettuce Coring Knives for Minimizing 

Escherichia coli O157:H7 

Contamination.’’ Journal of Food 

Protection 75, no. 3 (2012): 563–566. 

231. Cramer, M. M. Food Plant Sanitation: 

Design, Maintenance, and Good 

Manufacturing Practices. CRC Press, 

2006. 

232. Moore, C. M., Sheldon, B. W., and 

Jaykus, L.-A. ‘‘Transfer of Salmonella 

and Campylobacter from Stainless Steel 

to Romaine Lettuce.’’ Journal of Food 

Protection 66, no. 12 (2003): 2231–2236. 

233. Carrington, E. G. Evaluation of Sludge 

Treatments for Pathogen Reduction— 

Final Report. 2001. 

234. Bihn, E. A. and Gravani, R. B. ‘‘Role of 

Good Agricultural Practices in Fruit and 

Vegetable Safety.’’ In Microbiology of 

Fresh Produce, edited by Matthews, K. 

R., 21–52. Washington, DC: ASM Press, 

2006. 

235. ‘‘Investigation of the Taco John’s 

Escherichia coli O157:H7 Outbreak 

Associated with Iceberg Lettuce, Final 

Report.’’ California Food Emergency 

Response Team. http:// 

www.cdph.ca.gov/pubsforms/ 

Documents/fdb%20eru%20IceLet%20

TacoJohn022008.pdf. Last Modified 

2008. 

236. ‘‘The Fecal Bacteria.’’ Sadowsky, M. J. 

and Whitman, R. L. American Society for 

Microbiology. http://www.knovel.com/

web/portal/browse/display?_EXT_

KNOVEL_DISPLAY_bookid=4177. 

Accessed December 1, 2011. Last 

Modified 2011. 

237. Institute for Food Safety and Health and 

Sprout Safety Task Force. s.v. ‘‘Sprout 

Safety Training Workshop.’’ Accessed 

2011. 

238. Food and Drug Administration. s.v. 

‘‘HHS News, Consumers Advised of 

Risks Associated with Raw Sprouts.’’ 

Accessed 1999. 

239. Food and Drug Administration. s.v. 

‘‘Consumers Advised of Risks Associated 

with Eating Raw and Lightly Cooked 

Sprouts.’’ Accessed 2002. 

240. Food Safety Authority of Ireland. s.v. 

‘‘Guidelines on Safe Production of 

Ready-to-Eat Sprouted Seeds (Sprouts).’’ 

Accessed 2011. 

241. California Department of Health 

Services and Food and Drug 

Administration. s.v. ‘‘Safer Processing of 

Sprouts.’’ Accessed 2000. http:// 

www.cdph.ca.gov/pubsforms/

Documents/fdbIRfrm01.pdf. 

242. ‘‘Proposal P1004, Primary Production & 

Processing Standard for Seed Sprouts, 

Approval Report.’’ Food Standards 

Australia New Zealand. http:// 

www.foodstandards.gov.au/_srcfiles/ 

P1004%20PPPS%20for%20Sprouts%20

AppR.pdf. Accessed December 22, 2011. 

Last Modified 2011. 

243. Fett, W. F., Tortorell, M., and Fu, T. 

‘‘Seed Sprouts: the State of 

Microbiological Safety.’’ In Microbiology 

of Fresh Produce, edited by Matthews, K. 

R., 167–219. ASM Press, 2005. 

244. European Food Safety Authority and 

EFSA Panel on Biological Hazards 

(BIOHAZ). ‘‘Scientific Opinion on the 

risk posed by Shiga toxin-producing 

Escherichia coli (STEC) and other 

pathogenic bacteria in seeds and 

sprouted seeds.’’ EFSA Journal 9, no. 11 

(2011): 101–10.2903/j.efsa.2011.2424. 

245. ‘‘Code of Practice for the Hygienic 

Production of Sprouted Seeds.’’ 

Canadian Food Inspection Agency. 

http://www.inspection.gc.ca/english/ 

fssa/frefra/safsal/sprointe.shtml. Last 

Modified 2008. 

246. ‘‘Transcript of Proceedings of Public 

Meeting on Sprout Safety, May 17, 

2005.’’ http://www.fda.gov/Food/ 

FoodSafety/ProductSpecificInformation/

FruitsVegetablesJuices/ucm078701.htm. 

Last Modified 2010. 

247. Steinmuller, N., Demma, L., Bender, J. 

B. et al. ‘‘Outbreak of Enteric Disease 

Associated with Animal Contact: Not 

Just a Foodborne Problem Anymore.’’ 

Clinical Infectious Diseases 43, (2006): 

1596–1602. 

248. Winthrop, K. L., Palumbo, M. S., Farrar, 

J. A. et al. ‘‘Alfalfa Sprouts and 

Salmonella Kottbus Infection: A 

Multistate Outbreak following 

Inadequate Seed Disinfection with Heat 

and Chlorine.’’ Journal of Food 

Protection 66, no. 1 (2003): 13–17. 

249. Gill, C. J., Keene, W. E., Mohle-Boetani, 

J. C. et al. ‘‘Alfalfa Seed Decontamination 

in Salmonella Outbreak.’’ Emerging 

Infectious Diseases 9, no. 4 (2003): 474– 

479. 

250. Brooks, J. T., Rowe, S. Y., Shillam, P. et 

al. ‘‘Salmonella Typhimurium Infections 

Transmitted by Chlorine-pretreated 

Clover Sprout Seeds.’’ American Journal 

of Epidemiology 154, no. 11 (2001): 

1020–1028. 

251. Montville, R. and Schaffner, D. ‘‘Monte 

Carlo Simulation of Pathogen Behavior 

during the Sprout Production Process.’’ 

Applied and Environmental 

Microbiology 71, no. 2 (2005): 746–753. 

10.1128/?AEM.71.2.746–753.2005. 

252. ‘‘Recall—Firm Press Release, 

Amalgamated Produce, Inc. Recalls 

Sprouts in the North Eastern United 

States Because of Possible Health Risks.’’ 

Food and Drug Administration. http:// 

www.fda.gov/Safety/Recalls/

ArchiveRecalls/2009/ucm135947.htm. 

Accessed December 23, 2011. Last 

Modified 2009. 

253. Food and Drug Administration. s.v. 

‘‘Recalls: Listeria monocytogenes in 

Sprouts.’’ Accessed 2011. 

254. ‘‘Listeria Guidelines for Industry.’’ 

U.S.Department of Agriculture and Food 

Safety and Inspection Service. http:// 

www.fsis.usda.gov/OA/topics/

lmguide.htm. Last Modified 1999. 

255. Fu, T., Stewart, D., Reineke, K. et al. 

‘‘Use of Spent Irrigation Water for 

Microbiological Analysis of Alfalfa 

Sprouts.’’ Journal of Food Protection 64, 

no. 6 (2001): 802–806. 

256. Smith, M. A. and Food and Drug 

Administration, ‘‘Memorandum to the 

Record’’, 2011. 

257. Chen, Y., Scott, V. N., Freier, T. A. et 

al. ‘‘Control of Salmonella in Lowmoisture Foods III: Process Validation 

and Environmental Monitoring.’’ Food 

Protection Trends 29, no. 8 (2009): 493– 

508. 

258. International Commission for the 

Microbiological Specifications of Foods 

(ICMSF). ‘‘Sampling to Assess Control of 

the Environment.’’ In Microorganisms in 

Foods 7, 362-Kluwer Academic/Plenum 

Publishers, 2002. 

259. Tompkin, R. B. ‘‘Control of Listeria 

monocytogenes in the food-processing 

environment.’’ Journal of Food 

Protection 65, no. 4 (2002): 709–725. 

260. ‘‘Guidance for Industry: Control of 

Listeria monocytogenes in Refrigerated 

for Frozen Ready-To-Eat Foods; Draft 

Guidance.’’ Food and Drug 

Administration. http://www.fda.gov/

Food/GuidanceComplianceRegulatory

Information/GuidanceDocuments/Food

ProcessingHACCP/ucm073110.htm. 

Accessed December 28, 2011. Last 

Modified 2008. 

261. ‘‘Instruction Recordkeeping (NOP 

2602).’’ United States Department of 

Agriculture. http://www.ams.usda.gov/ 

AMSv1.0/getfile?dDocName=

STELPRDC5087110. Last Modified 2012. 

262. Florida Department of Agriculture and 

Consumer Services. Tomato Best 

Practices Manual. Florida Department of 

Agriculture and Consumer Services, 

2007. http://www.freshfromflorida.com/ 

fs/TomatoBestPractices.pdf. Accessed 

11–29–2011. 

263. ‘‘LGMA, California Leafy Green 

Products.’’ www.caleafygreens.ca.gov./ 

Accessed February 23, 2012. Last 

Modified 2012. 

264. ‘‘Prepare.’’ Merriam-Webster Online. 

Dictionary and Thesaurus—MerriamWebster Online. www.merriamwebster.com/dictionary/prepare. 

Accessed February 26, 2012. Last 

Modified 2012. 

265. ‘‘Fda’s analysis to examine the impacts 

of the Produce Safety proposed rule 

under Executive Order 12866, Executive 

Order 13563, the Regulatory Flexibility 

Act (5 U.S.C. 601–612), the Unfunded 

Mandates Reform Act of 1995 (Public 

Law 104–4), and the Paperwork 

Reduction Act of 1995 (44 U.S.C. 3501– 

3520)’’. 

266. Proffitt, L. D. and McCarthy, A. M. s.v. 

‘‘Memorandum to the Record.’’ Accessed 

2012. 

267. ‘‘Multistate Outbreak of Listeriosis 

Linked to Whole Cantaloupes from 

Jensen Farms, Colorado.’’ Centers for 

mstockstill on DSK4VPTVN1PROD with 

3628 Federal Register / Vol. 78, No. 11 / Wednesday, January 16, 2013 / Proposed Rules 

Disease Control and Prevention. http:// 

www.cdc.gov/listeria/outbreaks/

cantaloupes-jensen-farms/. Accessed 

December 28, 2011. Last Modified 2011. 

268. Norton, D. M. and Braden, C. R. 

‘‘Foodborne Listeriosis.’’ In Listeria, 

Listeriosis, and Food Safety, edited by 

Ryser, Elliot T and Marth, Elmer H., CRC 

Press, 2007. 

269. Schlech, W. F., Lavigne, P. M., 

Bortolussi, R. A. et al. ‘‘Epidemic 

Listeriosis—Evidence for Transmission 

by Food.’’ New England Journal of 

Medicine 308, no. 4 (1983): 203–206. 

270. Ho, J. L., Shands, K. N., Friedland, G. 

et al. ‘‘An outbreak of type 4b Listeria 

monocytogenes infection involving 

patients from eight Boston hospitals.’’ 

Archives of Internal Medicine 146, no. 3 

(1986): 520–524. 

271. ‘‘FDA Lab Results Positive for Listeria at 

SanGar Fresh Cut Produce.’’ Food and 

Drug Administration. http:// 

www.fda.gov/Food/FoodSafety/ProductSpecificInformation/

FruitsVegetablesJuices/ucm232237.htm. 

Accessed December 28, 2011. Last 

Modified 2010. 

272. ‘‘Investigation of an Outbreak of 

Salmonella Saintpaul Infections Linked 

to Raw Alfalfa Sprouts.’’ Centers for 

Disease Control and Prevention. http:// 

www.cdc.gov/salmonella/saintpaul/

alfalfa/archive/042709.html. Accessed 

December 28, 2011. Last Modified 2009. 

273. ‘‘Information on the Recalled Jensen 

Farms Whole Cantaloupes.’’ Food and 

Drug Administration. http:// 

www.fda.gov/Food/FoodSafety/ 

CORENetwork/ucm272372.htm#report. 

Last Modified 2011. 

List of Subjects 

21 CFR Part 16 

Administrative practice and 

procedure. 

21 CFR Part 112 

Foods, Fruits and vegetables, 

Incorporation by reference, Packaging 

and containers, Recordkeeping 

requirements, Safety. 

Therefore, under the Federal Food, 

Drug, and Cosmetic Act and under 

authority delegated to the Commissioner 

of Food and Drugs, it is proposed that 

21 CFR Chapter I be amended to read as 

follows: 

PART 16—REGULATORY HEARING 

BEFORE THE FOOD AND DRUG 

ADMINISTRATION 

■ 1. The authority citation for 21 CFR 

part 16 continues to read as follows: 

Authority: 15 U.S.C. 1451–1461; 21 U.S.C. 

141–149, 321–394, 467f, 679, 821, 1034; 28 

U.S.C. 2112; 42 U.S.C. 201–262, 263b, 364. 

■ 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) * * * 

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), relating to withdrawal of a 

qualified exemption. 

* * * * * 

■ 3. Add part 112 to read as follows: 

PART 112—STANDARDS FOR THE 

GROWING, HARVESTING, PACKING, 

AND HOLDING OF PRODUCE FOR 

HUMAN CONSUMPTION 

Subpart A—General Provisions 

Sec. 

112.1 What food is covered by this part? 

112.2 What produce is not covered by this 

part? 

112.3 What definitions apply to this part? 

112.4 Who is subject to the requirements of 

this part? 

112.5 Who is eligible for a qualified 

exemption and associated modified 

requirements based on average monetary 

value of all food sold and direct farm 

marketing? 

112.6 What modified requirements apply to 

me if I am eligible for a qualified 

exemption in accordance with § 112.5? 

Subpart B—General Requirements 

112.11 What general requirements apply to 

persons who are subject to this part? 

112.12 Are there any alternatives to the 

requirements established in this part? 

Subpart C—Standards Directed to 

Personnel Qualifications and Training 

112.21 What requirements apply regarding 

qualifications and training for personnel 

who handle (contact) covered produce or 

food-contact surfaces? 

112.22 What minimum requirements apply 

for training personnel who conduct a 

covered activity? 

112.23 What requirements apply regarding 

supervisors? 

112.30 Under this subpart, what 

requirements apply regarding records? 

Subpart D—Standards Directed to Health 

and Hygiene 

112.31 What measures must I take to 

prevent ill or infected persons from 

contaminating covered produce with 

microorganisms of public health 

significance? 

112.32 What hygienic practices must 

personnel use? 

112.33 What measures must I take to 

prevent visitors from contaminating 

covered produce and food-contact 

surfaces with microorganisms of public 

health significance? 

Subpart E—Standards Directed to 

Agricultural Water 

112.41 What requirements apply to the 

quality of agricultural water? 

112.42 What measures must I take with 

respect to my agricultural water sources, 

water distribution system, and pooling of 

water? 

112.43 What treatment of agricultural water 

is required, and what requirements apply 

to treating agricultural water? 

112.44 What testing is required for 

agricultural water, and what must I do 

based on the test results? 

112.45 How often must I test agricultural 

water that is subject to requirements of 

§ 112.44? 

112.46 What measures must I take for water 

that I use during harvest, packing, and 

holding activities for covered produce? 

112.50 Under this subpart, what 

requirements apply regarding records? 

Subpart F—Standards Directed to 

Biological Soil Amendments of Animal 

Origin and Human Waste 

112.51 What requirements apply for 

determining the status of a biological soil 

amendment of animal origin? 

112.52 How must I handle, convey, and 

store biological soil amendments of 

animal origin? 

112.53 What prohibitions apply regarding 

use of human waste? 

112.54 What treatment processes are 

acceptable for a biological soil 

amendment of animal origin that I apply 

in the growing of covered produce? 

112.55 What microbial standards apply to 

the treatment processes in § 112.54? 

112.56 What application requirements and 

minimum application intervals apply to 

biological soil amendments of animal 

origin? 

112.60 Under this subpart, what 

requirements apply regarding records? 

Subpart G—[Reserved] 

Subpart H—[Reserved] 

Subpart I—Standards Directed to 

Domesticated and Wild Animals 

112.81 How do the requirements of this 

subpart apply to areas where covered 

activities take place? 

112.82 What requirements apply regarding 

domesticated animals that I allow to 

graze in fields or use as working animals 

where I grow covered produce? 

112.83 What requirements apply regarding 

animal intrusion? 

Subpart J—[Reserved] 

Subpart K—Standards Directed to Growing, 

Harvesting, Packing, and Holding Activities 

112.111 What measures must I take if I 

grow, harvest, pack or hold both covered 

and excluded produce? 

112.112 What measures must I take during 

harvest activities? 

112.113 How must I handle harvested 

covered produce during covered 

activities? 

mstockstill on DSK4VPTVN1PROD with 

Federal Register / Vol. 78, No. 11 / Wednesday, January 16, 2013 / Proposed Rules 3629 

112.114 What requirements apply to 

dropped covered produce? 

112.115 What measures must I take when 

packaging covered produce? 

112.116 What measures must I take when 

using food-packing (including food 

packaging) material? 

Subpart L—Standards Directed to 

Equipment, Tools, Buildings, and Sanitation 

112.121 What equipment and tools are 

subject to the requirements of this 

subpart? 

112.122 What buildings are subject to the 

requirements of this subpart? 

112.123 What requirements apply regarding 

equipment and tools subject to this 

subpart? 

112.124 What requirements apply to 

instruments and controls used to 

measure, regulate, or record? 

112.125 What requirements apply to 

equipment that is subject to this subpart 

used in the transport of covered 

produce? 

112.126 What requirements apply to my 

buildings? 

112.127 What requirements apply regarding 

domesticated animals in and around a 

fully-enclosed building? 

112.128 What requirements apply regarding 

pest control in buildings? 

112.129 What requirements apply to toilet 

facilities? 

112.130 What requirements apply for handwashing facilities? 

112.131 What must I do to control and 

dispose of sewage? 

112.132 What must I do to control and 

dispose of trash, litter, and waste in areas 

used for covered activities? 

112.133 What requirements apply to 

plumbing? 

112.134 What must I do to control animal 

excreta and litter from domesticated 

animals that are under my control? 

112.140 Under this subpart, what 

requirements apply regarding records? 

Subpart M—Standards Directed to Sprouts 

112.141 What requirements apply to seeds 

or beans used to grow sprouts? 

112.142 What measures must I take for 

growing, harvesting, packing, and 

holding sprouts? 

112.143 What testing must I do during 

growing, harvesting, packing, and 

holding sprouts? 

112.144 What requirements apply to testing 

the environment for Listeria species or L. 

monocytogenes? 

112.145 What actions must I take if the 

growing, harvesting, packing, or holding 

environment tests positive for Listeria 

species or L. monocytogenes? 

112.146 What must I do to collect and test 

samples of spent sprout irrigation water 

or sprouts? 

112.150 Under this subpart, what 

requirements apply regarding records? 

Subpart N—Analytical Methods 

112.151 What methods must I use to test 

the quality of water to satisfy the 

requirements of § 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 

Records That You Must Establish and Keep 

112.161 What general requirements apply 

to records required under this part? 

112.162 Where must I store records? 

112.163 May I use existing records to satisfy 

the requirements of this part? 

112.164 How long must I keep records? 

112.165 What formats are acceptable for the 

records I keep? 

112.166 What requirements apply for 

making records available and accessible 

to FDA? 

112.167 Can records that I provide to FDA 

be disclosed to persons outside of FDA? 

Subpart P—Variances 

112.171 Who may request a variance from 

the requirements of this part? 

112.172 How may a State or foreign country 

request a variance from one or more 

requirements of this part? 

112.173 What must be included in the 

Statement of Grounds in a petition 

requesting a variance? 

112.174 What data and information 

submitted in a petition requesting a 

variance are publicly available? 

112.175 Who responds to a petition 

requesting a variance? 

112.176 What process applies to a petition 

requesting a variance? 

112.177 Can an approved variance apply to 

any person other than those identified in 

the petition requesting that variance? 

112.178 Under what circumstances may 

FDA deny a petition requesting a 

variance? 

112.179 When does a variance approved by 

FDA become effective? 

112.180 Under what circumstances may 

FDA modify or revoke an approved 

variance? 

112.181 What procedures apply if FDA 

determines that an approved variance 

should be modified or revoked? 

112.182 What are the permissible types of 

variances that may be granted? 

Subpart Q—Compliance and Enforcement 

112.191 How do the criteria and definitions 

in this part apply to the Federal Food, 

Drug, and Cosmetic Act and the Public 

Health Service Act? 

112.192 What is the result of a failure to 

comply with this part? 

112.193 What are the provisions for 

coordination of education and 

enforcement? 

Subpart R—Withdrawal of Qualified 

Exemption 

112.201 Under what circumstances can 

FDA withdraw a qualified exemption in 

accordance with the requirements of 

§ 112.5? 

112.202 What procedure will FDA use to 

withdraw an exemption? 

112.203 What information must FDA 

include in an order to withdraw a 

qualified exemption? 

112.204 What must I do if I receive an order 

to withdraw a qualified exemption 

applicable to my farm? 

112.205 Can I appeal or request a hearing 

on an order to withdraw a qualified 

exemption applicable to my farm? 

112.206 What is the procedure for 

submitting an appeal? 

112.207 What is the procedure for 

requesting an informal hearing? 

112.208 What requirements are applicable 

to an informal hearing? 

112.209 Who is the presiding officer for an 

appeal and for an informal hearing? 

112.210 What is the timeframe for issuing a 

decision on an appeal? 

112.211 When is an order to withdraw a 

qualified exemption applicable to a farm 

revoked? 

Authority: 21 U.S.C. 321, 331, 342, 350h, 

371; 42 U.S.C. 243, 264, 271. 

Subpart A—General Provisions 

§ 112.1 What food is covered by this part? 

(a) Unless it is excluded from this part 

under § 112.2, food that is produce 

within the meaning of this part and that 

is a raw agricultural commodity (RAC) 

is covered by this part. This includes a 

produce RAC that is grown domestically 

and a produce RAC that will be 

imported or offered for import in any 

State or territory of the United States, 

the District of Columbia, or the 

Commonwealth of Puerto Rico. 

(b) For the purpose of this part and 

subject to the exemptions and qualified 

exemptions therein, covered produce 

includes all of the following: 

(1) Fruits and vegetables such as 

almonds, apples, apricots, aprium, asian 

pear, avocados, babaco, bamboo shoots, 

bananas, Belgian endive, blackberries, 

blueberries, broccoli, cabbage, 

cantaloupe, carambola, carrots, 

cauliflower, celery, cherries, citrus 

(such as clementine, grapefruit, lemons, 

limes, mandarin, oranges, tangerines, 

tangors, and uniq fruit), cucumbers, 

curly endive, garlic, grapes, green beans, 

guava, herbs (such as basil, chives, 

cilantro, mint, oregano, and parsley), 

honeydew, kiwifruit, lettuce, mangos, 

other melons (such as canary, crenshaw 

and persian), mushrooms, nectarine, 

onions, papaya, passion fruit, peaches, 

pears, peas, peppers (such as bell and 

hot), pineapple, plums, plumcot, radish, 

raspberries, red currant, scallions, snow 

peas, spinach, sprouts (such as alfalfa 

and mung bean), strawberries, summer 

squash (such as patty pan, yellow and 

zucchini), tomatoes, walnuts, 

watercress, and watermelon; and 

(2) Mixes of intact fruits and 

vegetables (such as fruit baskets). 

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§ 112.2 What produce is not covered by 

this part? 

(a) The following produce is not 

covered by this part: 

(1) Produce that is rarely consumed 

raw, specifically the produce on the 

following exhaustive list—arrowhead, 

arrowroot, artichokes, asparagus, beets, 

black-eyed peas, bok choy, brussels 

sprouts, chick-peas, collard greens, 

crabapples, cranberries, eggplant, figs, 

ginger root, kale, kidney beans, lentils, 

lima beans, okra, parsnips, peanuts, 

pinto beans, plantains, potatoes, 

pumpkin, rhubarb, rutabaga, sugarbeet, 

sweet corn, sweet potatoes, taro, 

turnips, water chestnuts, winter squash 

(acorn and butternut squash), and yams; 

(2) Produce that is produced by an 

individual for personal consumption or 

produced for consumption on the farm 

or another farm under the same 

ownership; and 

(3) Produce that is not a raw 

agricultural commodity. 

(b) Covered produce is eligible for 

exemption from the requirements of this 

part (except as noted in paragraphs 

(b)(1), (b)(2), and (b)(3) of this section) 

under the following conditions: 

(1) The covered produce receives 

commercial processing that adequately 

reduces the presence of microorganisms 

of public health significance. Examples 

of commercial processing that 

adequately reduces the presence of 

microorganisms of public health 

significance are processing in 

accordance with the requirements of 

parts 113, 114, or 120 of this chapter, 

treating with a validated process to 

eliminate spore-forming microorganisms 

(such as processing to produce tomato 

paste or shelf-stable tomatoes), and 

processing such as refining or distilling 

produce into products such as sugar, oil, 

spirits, or similar products; 

(2) You must establish and keep 

documentation in accordance with the 

requirements of subpart O of this part, 

of the identity of the recipient of the 

covered produce that performs the 

commercial processing described in 

paragraph (b)(1) of this section; and 

(3) The requirements of this subpart 

and subpart Q of this part apply to such 

produce. 

§ 112.3 What definitions apply to this part? 

(a) The definitions and interpretations 

of terms in section 201 of the Federal 

Food, Drug, and Cosmetic Act (21 U.S.C. 

321) apply to such terms when used in 

this part. 

(b) For the purpose of this part, the 

following definitions of very small 

business and small business also apply: 

(1) Very small business. For the 

purpose of this part, your farm is a very 

small business if it is subject to this part 

and, on a rolling basis, the average 

annual monetary value of food (as 

defined in paragraph (c) of this section) 

you sold during the previous 3-year 

period is no more than $250,000. 

(2) Small business. For the purpose of 

this part, your farm is a small business 

if it is subject to this part and, on a 

rolling basis, the average annual 

monetary value of food (as defined in 

paragraph (c) of this section) you sold 

during the previous 3-year period is no 

more than $500,000; and your farm is 

not a very small business as provided in 

paragraph (b)(1) of this section. 

(c) For the purpose of this part, the 

following definitions also apply: 

Adequate means that which is needed 

to accomplish the intended purpose in 

keeping with good public health 

practice. 

Adequately reduce microorganisms of 

public health significance means reduce 

the presence of such microorganisms to 

an extent sufficient to prevent illness. 

Agricultural tea means a water extract 

of biological materials (such as humus, 

manure, non-fecal animal byproducts, 

peat moss, pre-consumer vegetative 

waste, table waste, or yard trimmings), 

excluding any form of human waste, 

produced to transfer microbial biomass, 

fine particulate organic matter, and 

soluble chemical components into an 

aqueous phase. Agricultural teas are 

held for longer than one hour before 

application. 

Agricultural tea additive means a 

nutrient source (such as molasses, yeast 

extract, or algal powder) added to 

agricultural tea to increase microbial 

biomass. 

Agricultural water means water used 

in covered activities on covered produce 

where water is intended to, or is likely 

to, contact covered produce or foodcontact surfaces, including water used 

in growing activities (including 

irrigation water applied using direct 

water application methods, water used 

for preparing crop sprays, and water 

used for growing sprouts) and in 

harvesting, packing, and holding 

activities (including water used for 

washing or cooling harvested produce 

and water used for preventing 

dehydration of covered produce). 

Animal excreta means solid or liquid 

animal waste. 

Application interval means the time 

interval between application of an 

agricultural input (such as a biological 

soil amendment of animal origin) to a 

growing area and harvest of covered 

produce from the growing area where 

the agricultural input was applied. 

Biological soil amendment means any 

soil amendment containing biological 

materials such as humus, manure, nonfecal animal byproducts, peat moss, preconsumer vegetative waste, sewage 

sludge biosolids, table waste, 

agricultural tea, or yard trimmings, 

alone or in combination. 

Biological soil amendment of animal 

origin means a biological soil 

amendment which consists, in whole or 

in part, of materials of animal origin, 

such as manure or non-fecal animal 

byproducts, or table waste, alone or in 

combination. The term ‘‘biological soil 

amendment of animal origin’’ does not 

include any form of human waste. 

Composting means a process to 

produce humus in which organic 

material is decomposed by the actions 

of microorganisms under thermophilic 

conditions for a designated period of 

time (for example, 3 days) at a 

designated temperature (for example, 

131°F (55 °C)), followed by a curing 

stage under cooler conditions. 

Covered activity means growing, 

harvesting, packing, or holding covered 

produce, provided that all covered 

produce used in covered packing or 

holding activities is grown, raised, or 

consumed on that farm or another farm 

under the same ownership. Covered 

activity does not include 

manufacturing/processing within the 

meaning defined in this chapter. This 

part does not apply to activities of a 

facility that are subject to part 110 of 

this chapter. 

Covered produce means produce that 

is subject to the requirements of this 

part in accordance with §§ 112.1 and 

112.2. The term ‘‘covered produce’’ 

refers to the harvestable or harvested 

part of the crop. 

Curing means the maturation stage of 

composting, which is conducted after 

much of the readily metabolized 

biological material has been 

decomposed, at cooler temperatures 

than those in the thermophilic phase of 

composting, to further reduce 

pathogens, promote further 

decomposition of cellulose and lignin, 

and stabilize composition. 

Direct water application method 

means using agricultural water in a 

manner whereby the water is intended 

to, or is likely to, contact covered 

produce or food-contact surfaces during 

use of the water. 

Farm means a facility (as defined in 

§ 1.227 of this chapter) in one general 

physical location devoted to the 

growing and harvesting of crops, the 

raising of animals (including seafood) or 

both. Farm includes: 

(i) Facilities that pack or hold food, 

provided that all food used in such 

activities is grown, raised, or consumed 

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on that farm or another farm under the 

same ownership; and 

(ii) Facilities that manufacture/ 

process food, provided that all food 

used in such activities is consumed on 

that farm or another farm under same 

ownership. 

Food means food as defined in section 

201(f) of the Federal Food, Drug, and 

Cosmetic Act and includes seeds and 

beans used to grow sprouts. 

Food-contact surfaces means those 

surfaces that contact human food and 

those surfaces from which drainage, or 

other transfer, onto the food or onto 

surfaces that contact the food ordinarily 

occurs during the normal course of 

operations. ‘‘Food-contact surfaces’’ 

includes food-contact surfaces of 

equipment and tools used during 

harvest, packing and holding. 

Growth media means material that 

acts as a substrate during the growth of 

covered produce (such as mushrooms 

and some sprouts) that contains, may 

contain, or consists of components that 

may include any animal waste (such as 

humus, manure, non-fecal animal 

byproducts or table waste). 

Harvesting applies to farms and farm 

mixed-type facilities and means 

activities that are traditionally 

performed by farms for the purpose of 

removing raw agricultural commodities 

from the place they were grown or 

raised and preparing them for use as 

food. Harvesting is limited to activities 

performed on raw agricultural 

commodities on the farm on which they 

were grown or raised, or another farm 

under the same ownership. Harvesting 

does not include activities that 

transform a raw agricultural commodity, 

as defined in section 201(r) of the 

Federal Food, Drug, and Cosmetic Act, 

into a processed food as defined in 

section 201(gg) of the Federal Food, 

Drug, and Cosmetic Act. Gathering, 

washing, trimming of outer leaves of, 

removing stems and husks from, sifting, 

filtering, threshing, shelling, and 

cooling raw agricultural commodities 

grown on a farm or another farm under 

the same ownership are examples of 

harvesting. 

Hazard means any biological agent 

that is reasonably likely to cause illness 

or injury in the absence of its control. 

Holding means storage of food. 

Holding facilities include warehouses, 

cold storage facilities, storage silos, 

grain elevators, and liquid storage tanks. 

For farms and farm mixed-type 

facilities, holding also includes 

activities traditionally performed by 

farms for the safe or effective storage of 

raw agricultural commodities grown or 

raised on the same farm or another farm 

under the same ownership, but does not 

include activities that transform a raw 

agricultural commodity, as defined in 

section 201(r) of the Federal Food, Drug, 

and Cosmetic Act, into a processed food 

as defined in section 201(gg) of the 

Federal Food, Drug, and Cosmetic Act. 

Humus means a stabilized (i.e., 

finished) biological soil amendment 

produced through a controlled 

composting process. 

Manufacturing/processing means 

making food from one or more 

ingredients, or synthesizing, preparing, 

treating, modifying or manipulating 

food, including food crops or 

ingredients. Examples of 

manufacturing/processing activities are 

cutting, peeling, trimming, washing, 

waxing, eviscerating, rendering, 

cooking, baking, freezing, cooling, 

pasteurizing, homogenizing, mixing, 

formulating, bottling, milling, grinding, 

extracting juice, distilling, labeling, or 

packaging. For farms and farm mixedtype facilities, manufacturing/ 

processing does not include activities 

that are part of harvesting, packing, or 

holding. 

Manure means animal excreta, alone 

or in combination with litter (such as 

straw and feathers used for animal 

bedding) for use as a soil amendment. 

Microorganisms means yeasts, molds, 

bacteria, viruses, protozoa, and 

microscopic parasites and includes 

species having public health 

significance. The term ‘‘undesirable 

microorganisms’’ includes those 

microorganisms that are of public health 

significance, that subject food to 

decomposition, that indicate that food is 

contaminated with filth, or that 

otherwise may cause food to be 

adulterated. 

Mixed-type facility means an 

establishment that engages in both 

activities that are exempt from 

registration under section 415 of the 

Federal Food, Drug, and Cosmetic Act 

(21 U.S.C. 350d) and activities that 

require the establishment to be 

registered. An example of such a facility 

is a ‘‘farm mixed-type facility,’’ which is 

an establishment that grows and 

harvests crops or raises animals and 

may conduct other activities within the 

farm definition, but also conducts 

activities that require the establishment 

to be registered. 

Monitor means to conduct a planned 

sequence of observations or 

measurements to assess whether a 

process, point or procedure is under 

control and, when applicable, to 

produce an accurate record of the 

observation or measurement. 

Non-fecal animal byproduct means 

solid waste (other than excreta) that is 

animal in origin (such as meat, fat, dairy 

products, eggs, carcasses, blood meal, 

bone meal, fish meal, shellfish waste 

(such as crab, shrimp, and lobster 

waste), fish emulsions, and offal) and is 

generated by commercial, institutional, 

or agricultural operations. 

Packaging (when used as a verb) 

means placing food into a container that 

directly contacts the food and that the 

consumer receives. 

Packing means placing food into a 

container other than packaging the food. 

For farms and farm mixed-type 

facilities, packing also includes 

activities (which may include 

packaging) traditionally performed by 

farms to prepare raw agricultural 

commodities grown or raised on the 

same farm or another farm under the 

same ownership for storage and 

transport, but does not include activities 

that transform a raw agricultural 

commodity, as defined in section 201(r) 

of the Federal Food, Drug, and Cosmetic 

Act, into a processed food as defined in 

section 201(gg) of the Federal Food, 

Drug, and Cosmetic Act. 

Pest means any objectionable animals 

or insects including birds, rodents, flies, 

and larvae. 

Pre-consumer vegetative waste means 

solid waste that is purely vegetative in 

origin, not considered yard trash, and 

derived from commercial, institutional, 

or agricultural operations without 

coming in contact with animal products, 

byproducts or manure or with an end 

user (consumer). Pre-consumer 

vegetative waste includes material 

generated by farms, packing houses, 

canning operations, wholesale 

distribution centers and grocery stores; 

products that have been removed from 

their packaging (such as out-of-date 

juice, vegetables, condiments, and 

bread); and associated packaging that is 

vegetative in origin (such as paper or 

corn-starch based products). Preconsumer vegetative waste does not 

include table waste, packaging that has 

come in contact with materials (such as 

meat) that are not vegetative in origin, 

or any waste generated by restaurants. 

Produce means any fruit or vegetable 

(including mixes of intact fruits and 

vegetables) and includes mushrooms, 

sprouts (irrespective of seed source), 

peanuts, tree nuts and herbs. A fruit is 

the edible reproductive body of a seed 

plant or tree nut (such as apple, orange 

and almond) such that fruit means the 

harvestable or harvested part of a plant 

developed from a flower. A vegetable is 

the edible part of an herbaceous plant 

(such as cabbage or potato) or fleshy 

fruiting body of a fungus (such as white 

button or shiitake) grown for an edible 

part such that vegetable means the 

harvestable or harvested part of any 

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plant or fungus whose fruit, fleshy 

fruiting bodies, seeds, roots, tubers, 

bulbs, stems, leaves, or flower parts are 

used as food and includes mushrooms, 

sprouts, and herbs (such as basil or 

cilantro). Produce does not include food 

grains meaning the small, hard fruits or 

seeds of arable crops, or the crops 

bearing these fruits or seeds, that are 

grown and processed for use as meal, 

flour, baked goods, cereals and oils 

rather than for fresh consumption 

(including cereal grains, pseudo cereals, 

oilseeds and other plants used in the 

same fashion). Examples of food grains 

include barley, dent- or flint-corn, 

sorghum, oats, rice, rye, wheat, 

amaranth, quinoa, buckwheat, cotton 

seed, and soybeans. 

Production batch of sprouts means all 

sprouts that are started at the same time 

in a single growing unit (e.g., a single 

drum or bin, or a single rack of trays 

that are connected to each other), 

whether or not the sprouts are grown 

from a single lot of seed (including, for 

example, when multiple types of seeds 

are grown in a single growing unit). 

Qualified end-user with respect to a 

food means the consumer of the food; or 

a restaurant or retail food establishment 

(as those terms are defined in § 1.227) 

that is located: 

(i) In the same State as the farm that 

produced the food; or 

(ii) Not more than 275 miles from 

such farm. The term ‘‘consumer’’ does 

not include a business. 

Raw agricultural commodity (RAC) 

means ‘‘raw agricultural commodity’’ as 

defined in section 201(r) of the Federal 

Food, Drug, and Cosmetic Act. 

Reasonably foreseeable hazard means 

a potential hazard that may be 

associated with the farm or the food. 

Sanitize means to adequately treat 

cleaned food-contact surfaces by a 

process that is effective in destroying 

vegetative cells of microorganisms of 

public health significance, and in 

substantially reducing numbers of other 

undesirable microorganisms, but 

without adversely affecting the product 

or its safety for the consumer. 

Sewage sludge biosolids means the 

solid or semi-solid residue generated 

during the treatment of domestic sewage 

in a treatment works within the 

meaning of the definition of ‘‘sewage 

sludge’’ in 40 CFR 503.9(w). 

Soil amendment means any chemical, 

biological, or physical material (such as 

elemental fertilizers, humus, manure, 

non-fecal animal byproducts, peat moss, 

perlite, pre-consumer vegetative waste, 

sewage sludge biosolids, table waste, 

agricultural tea and yard trimmings) 

intentionally added to the soil to 

improve the chemical or physical 

condition of soil in relation to plant 

growth or to improve the capacity of the 

soil to hold water. The term soil 

amendment also includes growth media 

that serve as the entire substrate during 

the growth of covered produce (such as 

mushrooms and some sprouts). 

Spent sprout irrigation water means 

water that has been used in the growing 

of sprouts. 

Static composting means a process to 

produce humus in which air is 

introduced into biological material (in a 

pile (or row) covered with at least 6 

inches of insulating material, or in an 

enclosed vessel) by a mechanism that 

does not include turning. Examples of 

structural features for introducing air 

include embedded perforated pipes and 

a constructed permanent base that 

includes aeration slots. Examples of 

mechanisms for introducing air include 

passive diffusion and mechanical means 

(such as blowers that suction air from 

the composting material or blow air into 

the composting material using positive 

pressure). 

Surface water means all water which 

is open to the atmosphere and subject to 

surface runoff, including water obtained 

from an underground aquifer that is 

held or conveyed in a manner that is 

open to the atmosphere, such as in 

canals, ponds, other surface 

containment or open conveyances. 

Table waste means any post-consumer 

food waste, irrespective of whether the 

source material is animal or vegetative 

in origin, derived from individuals, 

institutions, restaurants, retail 

operations, or other sources where the 

food has been served to a consumer. 

Turned composting means a process 

to produce humus in which air is 

introduced into biological material (in a 

pile, row, or enclosed vessel) by turning 

on a regular basis. Turning is the 

process of mechanically mixing 

biological material that is undergoing a 

composting process with the specific 

intention of moving the outer, cooler 

sections of the material being 

composted to the inner, hotter sections. 

Water distribution system means a 

system to carry water from its primary 

source to its point of use, including 

pipes, sprinklers, irrigation canals, 

pumps, valves, storage tanks, reservoirs, 

meters, and fittings. 

We means the U.S. Food and Drug 

Administration (FDA). 

Yard trimmings means purely 

vegetative matter resulting from 

landscaping maintenance or land 

clearing operations, including materials 

such as tree and shrub trimmings, grass 

clippings, palm fronds, trees, tree 

stumps, untreated lumber, untreated 

wooden pallets, and associated rocks 

and soils. 

You means a person who is subject to 

some or all of the requirements in this 

part. 

§ 112.4 Who is subject to the requirements 

of this part? 

(a) Except as provided in paragraph 

(b) of this section, if you are a farm or 

farm mixed-type facility with an average 

annual monetary value of food (as 

‘‘food’’ defined in § 112.3(c)) sold 

during the previous 3-year period of 

more than $25,000 (on a rolling basis), 

you are a ‘‘covered farm’’ subject to this 

part. If you are a covered farm subject 

to this part, you must comply with all 

applicable requirements of this part 

when you conduct a covered activity on 

covered produce. 

(b) You are not a covered farm if you 

satisfy the requirements in § 112.5 and 

we have not withdrawn your exemption 

in accordance with the requirements of 

subpart R of this part. 

§ 112.5 Who is eligible for a qualified 

exemption and associated modified 

requirements based on average monetary 

value of all food sold and direct farm 

marketing? 

(a) You are eligible for a qualified 

exemption and associated modified 

requirements in a calendar year if: 

(1) During the previous 3-year period 

preceding the applicable calendar year, 

the average annual monetary value of 

the food (as defined in § 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 food (as defined in 

§ 112.3(c)) you sold during the 3-year 

period preceding the applicable 

calendar year was less than $500,000, 

adjusted for inflation. 

(b) For the purpose of determining 

whether the average annual monetary 

value of all food sold during the 3-year 

period preceding the applicable 

calendar year was less than $500,000, 

adjusted for inflation, the baseline year 

for calculating the adjustment for 

inflation is 2011. 

§ 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 

exemption 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 the 

following modified requirements: 

(1) When a food packaging label is 

required on food that would otherwise 

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be covered produce under the Federal 

Food, Drug, and Cosmetic Act or its 

implementing regulations, you must 

include prominently and conspicuously 

on the food packaging label the name 

and the complete business address of 

the farm where the produce was grown. 

(2) When a food packaging label is not 

required on food that would otherwise 

be covered produce under the Federal 

Food, Drug, and Cosmetic Act, you must 

prominently and conspicuously display, 

at the point of purchase, the name and 

complete business address of the farm 

where the produce was grown, on a 

label, poster, sign, placard, or 

documents delivered 

contemporaneously with the produce in 

the normal course of business, or, in the 

case of Internet sales, in an electronic 

notice. 

(3) The complete business address 

that you must include in accordance 

with the requirements of paragraph 

(b)(1) or (b)(2) of this section must 

include the street address or post office 

box, city, state, and zip code for 

domestic farms, and comparable full 

address information for foreign farms. 

Subpart B—General Requirements 

§ 112.11 What general requirements apply 

to persons who are subject to this part? 

You must take appropriate measures 

to minimize the risk of serious adverse 

health consequences or death from the 

use of, or exposure to, covered produce, 

including those measures reasonably 

necessary to prevent the introduction of 

known or reasonably foreseeable 

hazards into covered produce, and to 

provide reasonable assurances that the 

produce is not adulterated under section 

402 of the Federal Food, Drug, and 

Cosmetic Act (21 U.S.C. 342) on account 

of such hazards. 

§ 112.12 Are there any alternatives to the 

requirements established in this part? 

(a) You may establish alternatives to 

the following specific requirements of 

this part, provided that you satisfy the 

requirements of paragraphs (b) and (c) of 

this section: 

(1) The requirements in § 112.44(c) for 

testing water, and taking action based 

on test results, when agricultural water 

is used during growing operations for 

covered produce (other than sprouts) 

using a direct water application method; 

(2) Composting treatment processes 

established in § 112.54(c)(1) and (c)(2); 

(3) The minimum application interval 

established in § 112.56(a)(1)(i) for an 

untreated biological soil amendment of 

animal origin that is reasonably likely to 

contact covered produce after 

application or for a compost agricultural 

tea that contains compost agricultural 

tea additives; and 

(4) The minimum application interval 

established in § 112.56(a)(4)(i) for a 

biological soil amendment of animal 

origin treated by a composting process 

that is reasonably likely to contact 

covered produce after application. 

(b) You may establish and use an 

alternative to any of the requirements 

listed in paragraph (a) of this section, 

provided you have adequate scientific 

data or information to support a 

conclusion that the alternative would 

provide the same level of public health 

protection as the applicable requirement 

established in this part (including 

meeting the same microbiological 

standards, where applicable), and 

would not increase the likelihood that 

your covered produce will be 

adulterated under section 402 of the 

Federal Food, Drug, and Cosmetic Act, 

in light of your covered produce, 

practices, and conditions, including 

agro-ecological conditions and 

application interval. 

(c) Scientific data and information 

used to support an alternative to a 

requirement listed in paragraph (a) of 

this section may be developed by you, 

available in the scientific literature, or 

available to you through a third party. 

You must establish and maintain 

documentation of the scientific data and 

information on which you rely in 

accordance with the requirements of 

subpart O of this part. 

Subpart C—Standards Directed to 

Personnel Qualifications and Training 

§ 112.21 What requirements apply 

regarding qualifications and training for 

personnel who handle (contact) covered 

produce or food-contact surfaces? 

All of the following requirements 

apply regarding qualifications and 

training for personnel who handle 

(contact) covered produce or foodcontact surfaces: 

(a) All personnel (including 

temporary, part time, seasonal, and 

contracted personnel) who handle 

covered produce or food-contact 

surfaces, or who are engaged in the 

supervision thereof, must receive 

adequate training, as appropriate to the 

person’s duties, upon hiring, at the 

beginning of each growing season (if 

applicable), and periodically thereafter. 

(b) All personnel (including 

temporary, part time, seasonal, and 

contracted personnel) who handle 

covered produce or food-contact 

surfaces, or who are engaged in the 

supervision thereof, must have the 

training, in combination with education 

or experience to perform the person’s 

assigned duties in a manner that ensures 

compliance with this part. 

(c) Training must be conducted in a 

manner that is easily understood by 

personnel being trained. 

(d) Training must be repeated as 

necessary and appropriate in light of 

observations or information indicating 

that personnel are not meeting 

standards established by FDA in 

subparts C through O of this part. 

§ 112.22 What minimum requirements 

apply for training personnel who conduct a 

covered activity? 

(a) At a minimum, all personnel who 

handle (contact) covered produce 

during covered activities or supervise 

the conduct of such activities must 

receive training that includes all of the 

following: 

(1) Principles of food hygiene and 

food safety; 

(2) The importance of health and 

personal hygiene for all personnel and 

visitors, including recognizing 

symptoms of a health condition that is 

reasonably likely to result in 

contamination of covered produce or 

food-contact surfaces with 

microorganisms of public health 

significance; and 

(3) The standards established by FDA 

in subparts C through O of this part that 

are applicable to the employee’s job 

responsibilities. 

(b) Persons who conduct harvest 

activities for covered produce must also 

receive training that includes all of the 

following: 

(1) Recognizing covered produce that 

should not be harvested, including 

covered produce that may be 

contaminated with known or reasonably 

foreseeable hazards; 

(2) Inspecting harvest containers and 

equipment to ensure that they are 

functioning properly, clean, and 

maintained so as not to become a source 

of contamination of covered produce 

with known or reasonably foreseeable 

hazards; and 

(3) Correcting problems with harvest 

containers or equipment, or reporting 

such problems to the supervisor (or 

other responsible party), as appropriate 

to the person’s job responsibilities. 

(c) At least one supervisor or 

responsible party for your farm must 

have successfully completed food safety 

training at least equivalent to that 

received under standardized curriculum 

recognized as adequate by the Food and 

Drug Administration. 

§ 112.23 What requirements apply 

regarding supervisors? 

You must assign or identify personnel 

to supervise (or otherwise be 

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responsible for) your operations to 

ensure compliance with the 

requirements of this part. 

§ 112.30 Under this subpart, what 

requirements apply regarding records? 

(a) You must establish and keep 

records required under this subpart C in 

accordance with the requirements of 

subpart O of this part. 

(b) You must establish and keep 

records of training that document 

required training of personnel, 

including the date of training, topics 

covered, and the persons(s) trained. 

Subpart D—Standards Directed to 

Health and Hygiene 

§ 112.31 What measures must I take to 

prevent ill or infected persons from 

contaminating covered produce with 

microorganisms of public health 

significance? 

(a) You must take measures to prevent 

contamination of covered produce and 

food-contact surfaces with 

microorganisms of public health 

significance from any person with an 

applicable health condition (such as a 

communicable illnesses that present a 

public health risk in the context of 

normal work duties, infection, open 

lesion, vomiting, or diarrhea). 

(b) The measures you must take to 

satisfy the requirements of paragraph (a) 

of this section must include all of the 

following measures: 

(1) Excluding any person from 

working in any operations that may 

result in contamination of covered 

produce or food-contact surfaces with 

microorganisms of public health 

significance when the person (by 

medical examination, the person’s 

acknowledgement, or observation) is 

shown to have, or appears to have, an 

applicable health condition, until the 

person’s health condition no longer 

presents a risk to public health; and 

(2) Instructing personnel to notify 

their supervisor(s) (or a responsible 

party) if they have, or if there is a 

reasonable possibility that they have an 

applicable health condition. 

§ 112.32 What hygienic practices must 

personnel use? 

(a) Personnel who work in an 

operation in which covered produce or 

food-contact surfaces are at risk of 

contamination with known or 

reasonably foreseeable hazards must use 

hygienic practices while on duty to the 

extent necessary to protect against such 

contamination. 

(b) The hygienic practices that 

personnel use to satisfy the 

requirements of paragraph (a) of this 

section when handling (contacting) 

covered produce or food-contact 

surfaces during a covered activity must 

include all of the following practices: 

(1) Maintaining adequate personal 

cleanliness to protect against 

contamination of covered produce and 

food-contact surfaces; 

(2) Avoiding contact with animals 

other than working animals, and taking 

appropriate steps to minimize the 

likelihood of contamination of covered 

produce when in direct contact with 

working animals; 

(3) Washing hands thoroughly, 

including scrubbing with soap and 

running water that satisfies the 

requirements of § 112.44(a) (as 

applicable) for water used to wash 

hands, and drying hands thoroughly 

using single-service towels, clean cloth 

towels, sanitary towel service or other 

adequate hand drying devices: 

(i) Before starting work; 

(ii) Before putting on gloves; 

(iii) After using the toilet; 

(iv) Upon return to the work station 

after any break or other absence from 

the work station; 

(v) As soon as practical after touching 

animals (including livestock and 

working animals), or any waste of 

animal origin; and 

(vi) At any other time when the hands 

may have become contaminated in a 

manner that is reasonably likely to lead 

to contamination of covered produce 

with known or reasonably foreseeable 

hazards; and 

(4) If you choose to use gloves in 

handling covered produce or foodcontact 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 

prevent visitors from contaminating 

covered produce and food-contact surfaces 

with microorganisms of public health 

significance? 

(a) A visitor is any person (other than 

personnel) who enters your covered 

farm with your permission. 

(b) You must make visitors aware of 

policies and procedures to protect 

covered produce and food-contact 

surfaces from contamination by people 

and take all steps reasonably necessary 

to ensure that visitors comply with such 

policies and procedures. 

(c) You must make toilet and handwashing facilities accessible to visitors. 

Subpart E—Standards Directed to 

Agricultural Water 

§ 112.41 What requirements apply to the 

quality of agricultural water? 

All agricultural water must be safe 

and of adequate sanitary quality for its 

intended use. 

§ 112.42 What measures must I take with 

respect to my agricultural water sources, 

water distribution system, and pooling of 

water? 

(a) At the beginning of a growing 

season, you must inspect the entire 

agricultural water system under your 

control (including water source, water 

distribution system, facilities, and 

equipment), to identify conditions that 

are reasonably likely to introduce 

known or reasonably foreseeable 

hazards into or onto covered produce or 

food-contact surfaces in light of your 

covered produce, practices, and 

conditions, including consideration of 

the following: 

(1) The nature of each agricultural 

water source (for example, ground water 

or surface water); 

(2) The extent of your control over 

each agricultural water source; 

(3) The degree of protection of each 

agricultural water source; 

(4) Use of adjacent or nearby land; 

and 

(5) The likelihood of introduction of 

known or reasonably foreseeable 

hazards to agricultural water by another 

user of agricultural water before the 

water reaches your covered farm. 

(b) You must adequately maintain all 

agricultural water sources that are under 

your control (such as wells) by regularly 

inspecting each source and keeping the 

source free of debris, trash, 

domesticated animals, and other 

possible sources of contamination of 

covered produce to the extent 

practicable and appropriate under the 

circumstances. 

(c) You must adequately maintain all 

agricultural water distribution systems 

as necessary and appropriate to prevent 

the water distribution system from being 

a source of contamination to covered 

produce, food-contact surfaces, areas 

used for a covered activity, or water 

sources, including by regularly 

inspecting and adequately storing all 

equipment used in the system. 

(d) You must immediately 

discontinue use of a source of 

agricultural water and/or its distribution 

system, and not use the water source 

and/or its distribution system when you 

have determined or have reason to 

believe that your agricultural water is 

not safe and of adequate sanitary quality 

for its intended use, until you either: 

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(1) Re-inspect the entire agricultural 

water system under your control, 

identify any conditions that are 

reasonably likely to introduce known or 

reasonably foreseeable hazards into or 

onto covered produce or food-contact 

surfaces, make necessary changes, and 

test the water to determine if your 

changes were effective and to ensure 

that your agricultural water is safe and 

of adequate sanitary quality for its 

intended use; or 

(2) Treat the water in accordance with 

the requirements of § 112.43. 

(e) As necessary and appropriate, you 

must implement measures reasonably 

necessary to reduce the potential for 

contamination of covered produce with 

known or reasonably foreseeable 

hazards as a result of pooling of water. 

For example, such measures may 

include using protective barriers or 

staking to keep covered produce from 

touching the ground or using an 

alternative irrigation method. 

§ 112.43 What treatment of agricultural 

water is required, and what requirements 

apply to treating agricultural water? 

(a) You must treat any agricultural 

water that you use (such as with an 

EPA-registered antimicrobial pesticide 

product) if you know or have reason to 

believe that the water is not safe and of 

adequate sanitary quality for its 

intended use. 

(b) Any method you use to treat 

agricultural water to satisfy the 

requirement in paragraph (a) of this 

section must be effective to make the 

water safe and of adequate sanitary 

quality for its intended use. 

(c)(1) You must deliver any treatment 

of agricultural water required by 

paragraph (a) of this section in a manner 

to ensure that the treated water is 

consistently safe and of adequate 

sanitary quality for its intended use. 

(2) You must monitor any treatment of 

agricultural water at a frequency 

adequate to ensure that the treated water 

is consistently safe and of adequate 

sanitary quality for its intended use. 

§ 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 part to ensure there is no 

detectable generic Escherichia coli (E. 

coli) in 100 milliliters (mL) of 

agricultural water when it is: 

(1) Used as sprout irrigation water; 

(2) Applied in any manner that 

directly contacts covered produce 

during or after harvest activities (for 

example, water that is applied to 

covered produce for washing or cooling 

activities, and water that is applied to 

harvested crops to prevent dehydration 

before cooling), including when used to 

make ice that directly contacts covered 

produce during or after harvest 

activities; 

(3) Used to make a treated agricultural 

tea; 

(4) Used to contact food-contact 

surfaces, or to make ice that will contact 

food-contact surfaces; or 

(5) Used for washing hands during 

and after harvest activities. 

(b) If you find that there is any 

detectable generic E. coli in 100 mL of 

water, you must immediately 

discontinue use of that source of 

agricultural water and/or its distribution 

system for the uses described in 

paragraph (a) of this section. Before you 

may use the water source and/or 

distribution system again for the uses 

described in paragraph (a) of this 

section, you must either re-inspect the 

entire agricultural water system under 

your control, identify any conditions 

that are reasonably likely to introduce 

known or reasonably foreseeable 

hazards into or onto covered produce or 

food-contact surfaces, make necessary 

changes, and retest the water to 

determine if your changes were effective 

and to ensure that the water meets the 

requirements of paragraph (a) of this 

section; or treat the water in accordance 

with the requirements of § 112.43. 

(c) When agricultural water is used 

during growing activities for covered 

produce (other than sprouts) using a 

direct water application method you 

must test the quality of water in 

accordance with one of the appropriate 

analytical methods in subpart N. If you 

find that there is more than 235 colony 

forming units (CFU) (or most probable 

number (MPN), as appropriate) generic 

E. coli per 100 mL for any single sample 

or a rolling geometric mean (n=5) of 

more than 126 CFU (or MPN, as 

appropriate) per 100 mL of water, you 

must immediately discontinue use of 

that source of agricultural water and/or 

its distribution system for the uses 

described in this paragraph. Before you 

may use the water source and/or 

distribution system again for the uses 

described in this paragraph, you must 

either re-inspect the entire agricultural 

water system under your control, 

identify any conditions that are 

reasonably likely to introduce known or 

reasonably foreseeable hazards into or 

onto covered produce or food-contact 

surfaces, make necessary changes, and 

retest the water to determine if your 

changes were effective; or treat the 

water in accordance with the 

requirements of § 112.43. 

(d) You may establish and use 

alternatives to the requirements 

established in paragraph (c) of this 

section, provided you satisfy the 

requirements of § 112.12. 

§ 112.45 How often must I test agricultural 

water that is subject to the requirements of 

§ 112.44? 

(a) You must test any agricultural 

water that is subject to the requirements 

of § 112.44 at the beginning of each 

growing season, and every three months 

thereafter during the growing season, 

except that there is no requirement to 

test water when: 

(1) You receive water from a Public 

Water System, as defined under the Safe 

Drinking Water Act (SDWA) regulations, 

40 CFR part 141, that furnishes water 

that meets the microbial requirements 

under those regulations or under the 

regulations of a State approved to 

administer the SDWA public water 

supply program, and you have Public 

Water System results or certificates of 

compliance that demonstrate that the 

water meets that requirement; 

(2) You receive water from a public 

water supply that furnishes water that 

meets the microbial requirement 

described in § 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 specified 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. 

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If the untreated surface water is— Then you must test the untreated surface 

water— 

(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 

containment (for example, 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 

necessary, including by establishing and 

following water-change schedules for recirculated water, to maintain adequate 

sanitary quality and minimize the 

potential for contamination of covered 

produce and food-contact surfaces with 

known or reasonably foreseeable 

hazards (for example, hazards that may 

be introduced into the water from soil 

adhering to the covered produce); 

(b) You must visually monitor the 

quality of water that you use during 

harvest, packing, and holding activities 

for covered produce (for example, water 

used for washing covered produce in 

dump tanks, flumes, or wash tanks, and 

water used for cooling covered produce 

in hydrocoolers) for build-up of organic 

material (such as soil and plant debris). 

(c) You must maintain and monitor 

the temperature of water at a 

temperature that is appropriate for the 

commodity and operation (considering 

the time and depth of submersion) and 

is adequate to minimize the potential for 

infiltration of microorganisms of public 

health significance into covered 

produce. 

§ 112.50 Under this subpart, what 

requirements apply regarding records? 

(a) You must establish and keep 

records required under this subpart E in 

accordance with the requirements of 

subpart O of this part. 

(b) You must establish and keep the 

following records: 

(1) The findings of the inspection of 

your agricultural water system in 

accordance with the requirements of 

§ 112.42(a); 

(2) Documentation of the results of 

any analytical tests conducted to 

determine whether agricultural water is 

safe and of adequate sanitary quality for 

its intended use; 

(3) Scientific data or information you 

rely on to support the adequacy of a 

method used to satisfy the requirements 

of § 112.43(b) and (c)(1); 

(4) Documentation of the results of 

water treatment monitoring under 

§ 112.43(c)(2); 

(5) Documentation of the results of 

water testing you perform to satisfy the 

requirements of § 112.44; and 

(6) Scientific data or information you 

rely on to support any alternative to the 

requirements established in § 112.44(c) 

for agricultural water used during 

growing activities using a direct water 

application method in accordance with 

the requirements of § 112.44(d). 

(7) Annual documentation of the 

results or certificates of compliance 

from a public water system under 

112.45(a)(1) or (a)(2), if applicable. 

Subpart F—Standards Directed to 

Biological Soil Amendments of Animal 

Origin and Human Waste 

§ 112.51 What requirements apply for 

determining the status of a biological soil 

amendment of animal origin? 

(a) A biological soil amendment of 

animal origin is treated if it has been 

processed to completion to adequately 

reduce microorganisms of public health 

significance in accordance with the 

requirements of § 112.54, or, in the case 

of an agricultural tea, the biological 

materials used to make the tea have 

been so processed and the water used to 

make the tea satisfies the requirements 

of 112.44(a). 

(b) A biological soil amendment of 

animal origin is untreated if it: 

(1) Has not been processed to 

completion in accordance with the 

requirements of § 112.54, or in the case 

of an agricultural tea, the biological 

materials used to make the tea have not 

been so processed or the water used to 

make the tea does not satisfy the 

requirements of 112.44(a); 

(2) Has become contaminated after 

treatment; 

(3) Has been recombined with an 

untreated biological soil amendment of 

animal origin; 

(4) Is or contains a component that is 

untreated waste that you know or have 

reason to believe is contaminated with 

a hazard or has been associated with 

foodborne illness; or 

(5) Is an agricultural tea that contains 

an agricultural tea additive. 

§ 112.52 How must I handle, convey, and 

store biological soil amendments of animal 

origin? 

(a) You must handle, convey and store 

any biological soil amendment of 

animal origin in a manner and location 

such that it does not become a potential 

source of contamination to covered 

produce, food-contact surfaces, areas 

used for a covered activity, water 

sources, and water distribution systems. 

(b) You must handle, convey and 

store any treated biological soil 

amendment of animal origin in a 

manner and location that minimizes the 

risk of it becoming contaminated by an 

untreated or in-process biological soil 

amendment of animal origin. 

(c) You must handle, convey, and 

store any biological soil amendment of 

animal origin that has become 

contaminated as if it was untreated. 

§ 112.53 What prohibitions apply 

regarding use of human waste? 

You may not use human waste for 

growing covered produce, except 

sewage sludge biosolids used in 

accordance with the requirements of 40 

CFR part 503, subpart D, or equivalent 

regulatory requirements. 

§ 112.54 What treatment processes are 

acceptable for a biological soil amendment 

of animal origin that I apply in the growing 

of covered produce? 

Each of the following treatment 

processes are acceptable for a biological 

soil amendment of animal origin that 

you apply in the growing of covered 

produce, provided that the resulting 

biological soil amendments are applied 

in accordance with the applicable 

requirements of § 112.56: 

(a) A scientifically valid controlled 

physical process (for example, thermal), 

chemical process (for example, high 

alkaline pH), or combination of 

scientifically valid controlled physical 

and chemical processes that has been 

demonstrated to satisfy the microbial 

standard in § 112.55(a) for Listeria 

monocytogenes (L. monocytogenes), 

Salmonella species, and E. coli 

O157:H7; 

(b) A scientifically valid controlled 

physical process, chemical process, or 

combination of scientifically valid 

controlled physical and chemical 

processes, that has been demonstrated 

to satisfy the microbial standard in 

§ 112.55(b) for Salmonella and fecal 

coliforms; or 

(c) A scientifically valid controlled 

composting process that has been 

demonstrated to satisfy the microbial 

standard in § 112.55(b) for Salmonella 

and fecal coliforms. Scientifically valid 

controlled composting processes 

include: 

(1) Static composting that maintains 

aerobic (i.e., oxygenated) conditions at a 

minimum of 131 °F (55 °C) for 3 days 

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and is followed by adequate curing, 

which includes proper insulation; 

(2) Turned composting that maintains 

aerobic conditions at a minimum of 

131 °F (55 °C) for 15 days, with a 

minimum of five turnings, and is 

followed by adequate curing, which 

includes proper insulation; or 

(3) Other scientifically valid, 

controlled composting processes, 

provided you satisfy the requirements of 

§ 112.12, including that the alternative 

process has been demonstrated to satisfy 

the microbial standard in § 112.55(b). 

§ 112.55 What microbial standards apply 

to the treatment processes in § 112.54? 

The following microbial standards 

apply to the treatment processes in 

§ 112.54 as set forth in that section. 

(a) For L. monocytogenes, Salmonella 

species, and E. coli O157:H7, the 

relevant standards in the table in this 

paragraph or; 

For the microorganism— The microbial standard is— 

(1) L. monocytogenes ................................................................................. Not detected using a method that can detect one colony forming unit 

(CFU) per 5 gram analytical portion. 

(2) Salmonella species ................................................................................ Less than three most probable numbers (MPN) per 4 grams of total 

solids (dry weight basis). 

(3) E. coli O157:H7 ..................................................................................... Less than 0.3 MPN per 1 gram analytical portion. 

(b) Less than three MPN Salmonella 

species per four grams of total solids 

(dry weight basis); and less than 1,000 

MPN fecal coliforms per gram of total 

solids (dry weight basis). 

§ 112.56 What application requirements 

and minimum application intervals apply to 

biological soil amendments of animal 

origin? 

(a) Except as provided in paragraph 

(b) of this section, you must apply the 

biological soil amendments of animal 

origin specified in the first column of 

the table in this paragraph in 

accordance with the application 

requirements specified in the second 

column of the table in this paragraph 

and the minimum application intervals 

specified in the third column of the 

table in this paragraph. 

If the biological soil amendment of 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 requirements 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 requirements of § 112.54(b) to meet the 

microbial standard in § 112.55(b).

In a manner that minimizes the potential for contact with 

covered produce during and after application 

0 days. 

(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 section, 

provided you satisfy the requirements of 

§ 112.12. 

§ 112.60 Under this subpart, what 

requirements apply regarding records? 

(a) You must establish and keep 

records required under this subpart F in 

accordance with the requirements of 

subpart O of this part. 

(b) For any biological soil amendment 

of animal origin you use, you must 

establish and keep the following 

records: 

(1) Documentation of the date of 

application of any untreated biological 

soil amendment of animal origin 

(including raw manure) or any 

biological soil amendment of animal 

origin treated by composting to a 

growing area and the date of harvest of 

covered produce from that growing area, 

except when covered produce does not 

contact the soil after application of the 

soil amendment; 

(2) For a treated biological soil 

amendment of animal origin you receive 

from a third party, documentation (such 

as a Certificate of Conformance) that: 

(i) The process used to treat the 

biological soil amendment of animal 

origin is a scientifically valid process 

that has been carried out with 

appropriate process monitoring; 

(ii) The applicable treatment process 

is periodically verified through testing 

using a scientifically valid analytical 

method on an adequately representative 

sample to demonstrate that the process 

satisfies the applicable microbial 

standard in § 112.55, including the 

results of such periodic testing; and 

(iii) The biological soil amendment of 

animal origin has been handled, 

conveyed and stored in a manner and 

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location to minimize the risk of 

contamination by an untreated or inprocess biological soil amendment of 

animal origin; 

(3) For a treated biological soil 

amendment of animal origin you 

produce for your own covered farm(s), 

documentation that process controls (for 

example, time, temperature and 

turnings) were achieved; 

(4) Scientific data or information you 

rely on to support any alternative 

composting process used to treat a 

biological soil amendment of animal 

origin in accordance with the 

requirements of § 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 covered 

activities take place? 

(a) The requirements of this subpart 

apply when a covered activity takes 

place in an outdoor area or a partiallyenclosed building and when, under the 

circumstances, there is a reasonable 

probability that animals will 

contaminate covered produce. 

(b) The requirements of this subpart 

do not apply when a covered activity 

takes place in a fully-enclosed building. 

§ 112.82 What requirements apply 

regarding domesticated animals that I allow 

to graze in fields or use as working animals 

where I grow covered produce? 

At a minimum, if you allow animals 

to graze or use them as working animals 

in fields where covered produce is 

grown, and under the circumstances 

there is a reasonable probability that 

grazing or working animals will 

contaminate covered produce, you must 

take the following measures: 

(a) An adequate waiting period 

between grazing and harvesting for 

covered produce in any growing area 

that was grazed to ensure the safety of 

the harvested crop; and 

(b) If working animals are used in a 

growing area where a crop has been 

planted, measures to prevent the 

introduction of known or reasonably 

foreseeable hazards into or onto covered 

produce. 

§ 112.83 What requirements apply 

regarding animal intrusion? 

(a) If under the circumstances there is 

a reasonable probability that animal 

intrusion will contaminate covered 

produce, you must monitor those areas 

that are used for a covered activity for 

evidence of animal intrusion: 

(1) As needed during the growing 

season based on: 

(i) Your covered produce; and 

(ii) Your observations and experience; 

and 

(2) Immediately prior to harvest. 

(b) If animal intrusion, as made 

evident by observation of significant 

quantities of animals, animal excreta or 

crop destruction via grazing, occurs, you 

must evaluate whether the covered 

produce can be harvested in accordance 

with the requirements of § 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, harvest, pack or hold both covered 

and excluded produce? 

If you grow, harvest, pack or hold 

produce that is not covered in this part 

(i.e., excluded produce in accordance 

with § 112.2) and also conduct such 

activities on covered produce, and the 

excluded produce is not grown, 

harvested, packed or held in accordance 

with this part, you must take measures 

during these covered activities, as 

applicable, to: 

(a) Keep covered produce separate 

from excluded produce; and 

(b) Adequately clean and sanitize, as 

necessary, any food-contact surfaces 

that contact excluded produce before 

using such food-contact surfaces for 

covered activities on covered produce. 

§ 112.112 What measures must I take 

during harvest activities? 

You must take all measures 

reasonably necessary to identify, and 

not harvest, covered produce that is 

reasonably likely to be contaminated 

with a known or reasonably foreseeable 

hazard, including steps to identify and 

not harvest covered produce that is 

visibly contaminated with animal 

excreta. 

§ 112.113 How must I handle harvested 

covered produce during covered activities? 

You must handle harvested covered 

produce in a manner that protects 

against contamination with known or 

reasonably foreseeable hazards—for 

example, by avoiding contact of cut 

surfaces of harvested produce with soil. 

§ 112.114 What requirements apply to 

dropped covered produce? 

You must not distribute covered 

produce that drops to the ground before 

harvest (dropped covered produce) 

unless it is exempt under § 112.2(b). 

Dropped covered produce does not 

include root crops (such as carrots) that 

grow underground or crops (such as 

cantaloupe) that grow on the ground. 

§ 112.115 What measures must I take 

when packaging covered produce? 

You must package covered produce in 

a manner that prevents the formation of 

Clostridium botulinum toxin if such 

toxin is a known or reasonably 

foreseeable hazard (such as for 

mushrooms). 

§ 112.116 What measures must I take 

when using food-packing (including food 

packaging) material? 

(a) You must use food-packing 

material that is adequate for its intended 

use. 

(b) If you reuse food-packing material, 

you must take steps to ensure that foodcontact surfaces are clean, such as by 

cleaning and sanitizing, when 

necessary, food-packing containers or 

using a clean liner. 

Subpart L—Standards Directed to 

Equipment, Tools, Buildings, and 

Sanitation 

§ 112.121 What equipment and tools are 

subject to the requirements of this subpart? 

Equipment and tools subject to the 

requirements of this subpart are those 

that are intended to, or likely to, contact 

covered produce; and those instruments 

or controls used to measure, regulate, or 

record conditions to control or prevent 

the growth of undesirable 

microorganisms or other contamination. 

Examples include knives, implements, 

mechanical harvesters, waxing 

machinery, cooling equipment 

(including hydrocoolers), grading belts, 

sizing equipment, palletizing 

equipment, and equipment used to store 

or convey harvested covered produce 

(such as containers, bins, food-packing 

material, dump tanks, flumes, and 

vehicles or other equipment used for 

transport that are intended to, or likely 

to, contact covered produce). 

§ 112.122 What buildings are subject to 

the requirements of this subpart? 

Buildings subject to the requirements 

of this subpart include: 

(a) Any fully- or partially-enclosed 

building used for covered activities, 

including minimal structures that have 

a roof but do not have any walls; and 

(b) Storage sheds, buildings, or other 

structures used to store food-contact 

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surfaces (such as harvest containers and 

food-packing materials). 

§ 112.123 What general requirements 

apply regarding equipment and tools 

subject to this subpart? 

All of the following requirements 

apply regarding equipment and tools 

subject to this subpart: 

(a) You must use equipment and tools 

that are of adequate design, 

construction, and workmanship to 

enable them to be adequately cleaned 

and properly maintained; and 

(b) Equipment and tools must be: 

(1) Installed and maintained as to 

facilitate cleaning of the equipment and 

of all adjacent spaces, and 

(2) Stored and maintained to protect 

covered produce from being 

contaminated with known or reasonably 

foreseeable hazards and to prevent the 

equipment and tools from attracting and 

harboring pests. 

(c) Seams on food-contact surfaces of 

equipment and tools that you use must 

be either smoothly bonded, or 

maintained to minimize accumulation 

of dirt, filth, food particles, and organic 

material and thus minimize the 

opportunity for harborage or growth of 

microorganisms. 

(d)(1) You must inspect, maintain, 

and clean and sanitize, when necessary 

and appropriate, all food-contact 

surfaces of equipment and tools used in 

covered activities as frequently as 

reasonably necessary to protect against 

contamination of covered produce. 

(2) You must maintain and clean all 

non-food-contact surfaces of equipment 

and tools subject to this subpart used 

during harvesting, packing, and holding 

as frequently as reasonably necessary to 

protect against contamination of 

covered produce. 

(e) If you use equipment such as 

pallets, forklifts, tractors, and vehicles 

such that they are intended to, or likely 

to, contact covered produce, you must 

do so in a manner that minimizes the 

potential for contamination of covered 

produce or food-contact surfaces with 

known or reasonably foreseeable 

hazards. 

§ 112.124 What requirements apply to 

instruments and controls used to measure, 

regulate, or record? 

Instruments or controls you use to 

measure, regulate, or record 

temperatures, hydrogen-ion 

concentration (pH), sanitizer efficacy or 

other conditions, in order to control or 

prevent the growth of undesirable 

microorganisms or other contamination, 

must be: 

(a) Accurate and precise as necessary 

and appropriate in keeping with their 

purpose; 

(b) Adequately maintained; and 

(c) Adequate in number for their 

designated uses. 

§ 112.125 What requirements apply to 

equipment that is subject to this subpart 

used in the transport of covered produce? 

Equipment that is subject to this 

subpart that you use to transport 

covered produce must be: 

(a) Adequately clean before use in 

transporting covered produce; and 

(b) Adequate for use in transporting 

covered produce. 

§ 112.126 What design and construction 

requirements apply to my buildings? 

All of the following design and 

construction requirements apply 

regarding buildings. 

(a) Buildings must be suitable in size, 

construction, and design to facilitate 

maintenance and sanitary operations for 

covered activities to reduce the 

potential for contamination of covered 

produce or food-contact surfaces with 

known or reasonably foreseeable 

hazards. Buildings must: 

(1) Provide sufficient space for 

placement of equipment and storage of 

materials; 

(2) Permit proper precautions to be 

taken to reduce the potential for 

contamination of covered produce, 

food-contact surfaces, or packing 

materials with known or reasonably 

foreseeable hazards. The potential for 

contamination must be reduced by 

effective design including the separation 

of operations in which contamination is 

likely to occur, by one or more of the 

following means: Location, time, 

partition, enclosed systems, or other 

effective means; and 

(3) Be constructed in such a manner 

that floors, walls, ceilings, fixtures, 

ducts and pipes can be adequately 

cleaned and kept in good repair, and 

that drip or condensate does not 

contaminate covered produce, foodcontact surfaces, or packing materials. 

(b) You must provide adequate 

drainage in all areas where normal 

operations release or discharge water or 

other liquid waste on the ground or 

floor of the building. 

§ 112.127 What requirements apply 

regarding domesticated animals in and 

around a fully-enclosed building? 

(a) You must take reasonable 

precautions to prevent contamination of 

covered produce, food-contact surfaces, 

and food-packing materials in fullyenclosed buildings with known or 

reasonably foreseeable hazards from 

domesticated animals by: 

(1) Excluding domesticated animals 

from fully-enclosed buildings where 

covered produce, food-contact surfaces, 

or food-packing material is exposed; or 

(2) Separating domesticated animals 

in a fully enclosed building from an area 

where a covered activity is conducted 

on covered produce by location, time, or 

partition. 

(b) Guard or guide dogs may be 

allowed in some areas of a fully 

enclosed building if the presence of the 

dogs is unlikely to result in 

contamination of produce, food-contact 

surfaces, or food-packing materials. 

§ 112.128 What requirements apply 

regarding pest control in buildings? 

(a) You must take those measures 

reasonably necessary to protect covered 

produce, food-contact surfaces, and 

food-packing materials from 

contamination by pests in buildings, 

including routine monitoring for pests 

as necessary and appropriate. 

(b) For fully-enclosed buildings, you 

must take measures to exclude pests 

from your buildings. 

(c) For partially-enclosed buildings, 

you must take measures to prevent pests 

from becoming established in your 

buildings (such as by use of screens or 

by monitoring for the presence of pests 

and removing them when present). 

§ 112.129 What requirements apply to 

toilet facilities? 

All of the following requirements 

apply to toilet facilities: 

(a) You must provide personnel with 

adequate, readily accessible toilet 

facilities, including toilet facilities 

readily accessible to growing areas 

during harvesting activities. 

(b) Your toilet facilities must be 

designed, located, and maintained to: 

(1) Prevent contamination of covered 

produce, food-contact surfaces, areas 

used for a covered activity, water 

sources, and water distribution systems 

with human waste; 

(2) Be directly accessible for servicing, 

be serviced and cleaned on a schedule 

sufficient to ensure suitability of use, 

and be kept supplied with toilet paper; 

and 

(3) Provide for the sanitary disposal of 

waste and toilet paper. 

(c) During growing activities that take 

place in a fully-enclosed building, and 

during covered harvesting, packing, or 

holding activities, you must provide a 

hand-washing station in sufficiently 

close proximity to toilet facilities to 

make it practical for persons who use 

the toilet facility to wash their hands. 

§ 112.130 What requirements apply for 

hand-washing facilities? 

All of the following requirements 

apply to hand-washing facilities: 

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(a) You must provide personnel with 

adequate, readily accessible handwashing facilities during growing 

activities that take place in a fullyenclosed building, and during covered 

harvest, packing, or holding activities. 

(b) Your hand-washing facilities must 

be furnished with: 

(1) Soap (or other effective surfactant); 

(2) Running water that satisfies the 

requirements of § 112.44(a) for water 

used to wash hands; and 

(3) Adequate drying devices (such as 

single service towels, clean cloth towels 

or sanitary towel service). 

(c) You must provide for appropriate 

disposal of waste (for example, waste 

water and used single-service towels) 

associated with a hand-washing facility 

and take appropriate measures to 

prevent waste water from a handwashing facility from contaminating 

covered produce, food-contact surfaces, 

areas used for a covered activity, 

agricultural water sources, and 

agricultural water distribution systems 

with known or reasonably foreseeable 

hazards. 

(d) You may not use hand antiseptic/ 

sanitizer or wipes as a substitute for 

soap and water. 

§ 112.131 What must I do to control and 

dispose of sewage? 

All of the following requirements 

apply for the control and disposal of 

sewage: 

(a) You must dispose of sewage into 

an adequate sewage or septic system or 

through other adequate means. 

(b) You must maintain sewage and 

septic systems in a manner that prevents 

contamination of covered produce, 

food-contact surfaces, areas used for a 

covered activity, agricultural water 

sources, and agricultural water 

distribution systems with known or 

reasonably foreseeable hazards. 

(c) You must manage and dispose of 

leakages or spills of human waste in a 

manner that prevents contamination of 

covered produce, and prevents or 

minimizes contamination of foodcontact surfaces, areas used for a 

covered activity, agricultural water 

sources, or agricultural water 

distribution systems. 

(d) After a significant event (such as 

flooding or an earthquake) that could 

negatively impact a sewage or septic 

system, you must take appropriate steps 

to ensure that sewage and septic 

systems continue to operate in a manner 

that does not contaminate covered 

produce, food-contact surfaces, areas 

used for a covered activity, agricultural 

water sources, or agricultural water 

distribution systems. 

§ 112.132 What must I do to control and 

dispose of trash, litter, and waste in areas 

used for covered activities? 

All of the following requirements 

apply to the control and disposal of 

trash, litter, and waste in areas used for 

covered activities: 

(a) You must convey, store, and 

dispose of trash, litter and waste to: 

(1) Minimize the potential for trash, 

litter, or waste to attract or harbor pests; 

and 

(2) Protect against contamination of 

covered produce, food-contact surfaces, 

areas used for a covered activity, 

agricultural water sources, and 

agricultural water distribution systems 

with known or reasonably foreseeable 

hazards. 

(b) You must adequately operate 

systems for waste treatment and 

disposal so that they do not constitute 

a potential source of contamination in 

areas used for a covered activity. 

§ 112.133 What requirements apply to 

plumbing? 

The plumbing must be of an adequate 

size and design and be adequately 

installed and maintained to: 

(a) Distribute water under pressure as 

needed, in sufficient quantities, in all 

areas where used for covered activities, 

for sanitary operations, or for handwashing and toilet facilities. 

(b) Properly convey sewage and liquid 

disposable waste; 

(c) Avoid being a source of 

contamination to covered produce, 

food-contact surfaces, areas used for a 

covered activity, or agricultural water 

sources; and 

(d) Not allow backflow from, or cross 

connection between, piping systems 

that discharge waste water or sewage 

and piping systems that carry water 

used for a covered activity, for sanitary 

operations, or for use in hand-washing 

facilities. 

§ 112.134 What must I do to control animal 

excreta and litter from domesticated 

animals that are under my control? 

(a) If you have domesticated animals, 

to prevent contamination of covered 

produce, food-contact surfaces, areas 

used for a covered activity, agricultural 

water sources, or agricultural water 

distribution systems with animal waste, 

you must: 

(1) Adequately control their excreta 

and litter; and 

(2) Maintain a system for control of 

animal excreta and litter. 

(b) [Reserved] 

§ 112.140 Under this subpart L, what 

requirements apply regarding records? 

(a) You must establish and keep 

records required under this subpart L in 

accordance with the requirements of 

subpart O of this part. 

(b) You must establish and keep 

documentation of the date and method 

of cleaning and sanitizing of equipment 

subject to this subpart used in: 

(1) Growing operations for sprouts; 

and 

(2) Covered harvesting, packing, or 

holding activities. 

Subpart M—Standards Directed to 

Sprouts 

§ 112.141 What requirements apply to 

seeds or beans used to grow sprouts? 

In addition to the requirements of this 

part, all of the following requirements 

apply to seeds or beans used to grow 

sprouts. 

(a) If your farm grows seeds or beans 

for use to grow sprouts, you must take 

measures reasonably necessary to 

prevent the introduction of known or 

reasonably foreseeable hazards into or 

onto seeds or beans that you will use for 

sprouting. 

(b) If you know or have reason to 

believe that a lot of seeds or beans have 

been associated with foodborne illness, 

you must not use that lot of seeds or 

beans to produce sprouts. 

(c) You must visually examine seeds 

and beans, and packaging used to ship 

seeds or beans, for signs of potential 

contamination with known or 

reasonably foreseeable hazards. 

§ 112.142 What measures must I take for 

growing, harvesting, packing, and holding 

sprouts? 

You must take all of the following 

measures for growing, harvesting, 

packing, and holding sprouts: 

(a) You must grow, harvest, pack, and 

hold sprouts in a fully-enclosed 

building. 

(b) Any food-contact surfaces you use 

to grow, harvest, pack, and hold sprouts 

must be cleaned and sanitized before 

contact with sprouts or seeds or beans 

used to grow sprouts. 

(c) You must treat seeds or beans that 

will be used to grow sprouts using a 

scientifically valid method immediately 

before sprouting to reduce 

microorganisms of public health 

significance. Prior treatment conducted 

by a grower, handler, or distributor of 

seeds or beans does not eliminate your 

responsibility to treat seeds or beans 

immediately before sprouting at your 

covered farm. 

§ 112.143 What testing must I do during 

growing, harvesting, packing, and holding 

sprouts? 

All of the following testing must be 

done during growing, harvesting, 

packing, and holding sprouts: 

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(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 

from each production batch of sprouts 

for E. coli O157:H7 and Salmonella 

species in accordance with the 

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 sprouts at the inprocess 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 the environment for Listeria species 

or L. monocytogenes? 

All of the following testing 

requirements apply for the growing, 

harvesting, packing, and holding 

environment for Listeria species or L. 

monocytogenes. 

(a) You must establish and implement 

a written environmental monitoring 

plan that is designed to identify L. 

monocytogenes if it is present in the 

growing, harvesting, packing, or holding 

environment. 

(b) Your written environmental 

monitoring plan must be directed to 

sampling and testing for either Listeria 

species or L. monocytogenes. 

(c) Your written environmental 

monitoring plan must include a 

sampling plan that specifies: 

(1) What you will test collected 

samples for (i.e., Listeria species or L. 

monocytogenes); 

(2) How often you will collect 

environmental samples, which must be 

no less than monthly; and 

(3) Sample collection sites; the 

number and location of sampling sites 

must be sufficient to determine whether 

measures are effective and must include 

appropriate food-contact surfaces and 

non-food-contact surfaces of equipment, 

and other surfaces within the growing, 

harvesting, packing, and holding 

environment. 

(d) You must collect environmental 

samples and test them for Listeria 

species or L. monocytogenes according 

to the method in § 112.152. 

§ 112.145 What actions must I take if the 

growing, harvesting, packing, or holding 

environment tests positive for Listeria 

species or L. monocytogenes? 

You must take the following actions if 

you detect Listeria species or L. 

monocytogenes in the growing, 

harvesting, packing, or holding 

environment: 

(a) Conduct additional testing of 

surfaces and areas surrounding the area 

where Listeria species or L. 

monocytogenes was detected to evaluate 

the extent of the problem, including the 

potential for Listeria species or L. 

monocytogenes to have become 

established in a niche; 

(b) Clean and sanitize the affected 

surfaces and surrounding areas; 

(c) Conduct additional microbial 

sampling and testing to determine 

whether the Listeria species or L. 

monocytogenes has been eliminated; 

(d) Conduct finished product testing 

when appropriate; and 

(e) Perform any other actions 

necessary to prevent reoccurrence of the 

contamination. 

§ 112.146 What must I do to collect and 

test samples of spent sprout irrigation 

water or sprouts? 

All of the following requirements 

apply for collecting and testing samples 

of spent sprout irrigation water or 

sprouts: 

(a) You must establish and implement 

a written sampling plan that identifies 

the number and location of samples (of 

spent sprout irrigation water or sprouts) 

to be collected for each production 

batch of sprouts to ensure that the 

collected samples are representative of 

the production batch when testing for 

contamination. 

(b) In accordance with the written 

sampling plan required under paragraph 

(a) of this section, you must aseptically 

collect samples of spent sprout 

irrigation water or sprouts, and test the 

collected samples for E. coli O157:H7 

and Salmonella species using a method 

that has been validated for its intended 

use (testing spent sprout irrigation water 

or sprouts) to ensure that the testing is 

accurate, precise, and sensitive in 

detecting these pathogens. 

§ 112.150 Under this subpart, what 

requirements apply regarding records? 

(a) You must establish and keep 

records required under this subpart M 

in accordance with the requirements of 

subpart O of this part. 

(b) You must establish and keep the 

following records: 

(1) Documentation of your treatment 

of seeds or beans to reduce 

microorganisms of public health 

significance in the seeds or beans, at 

your farm; 

(2) Your written environmental 

monitoring plan in accordance with the 

requirements of § 112.144; 

(3) Your written sampling plan for 

each production 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; 

(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 

accordance with the requirements of 

§ 112.146(b). 

Subpart N—Analytical Methods 

§ 112.151 What methods must I use to test 

the quality 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’’ (18th ed., revision 4, 

2011) which is incorporated by 

reference in accordance with 5 U.S.C. 

552(a) and 1 CFR part 51. Copies are 

available from the AOAC International, 

481 North Frederick Ave., suite 500, 

Gaithersburg, MD 20877, or at the 

National Archives and Records 

Administration (NARA). For 

information on the availability of this 

material at NARA, call 202–741–6030, 

or go to http://www.archives.gov/ 

federal_register/ 

code_of_federal_regulations/ 

ibr_locations.html; or 

(2) As published in the Standards 

Methods for the Examination of Water 

and Wastewater (21st ed., 2005), 

American Public Health Association 

(APHA), which is incorporated by 

reference in accordance with 5 U.S.C. 

552(a) and 1 CFR part 51. You may 

obtain a copy from the APHA, 800 I St. 

NW., Washington, DC 20001, 202–777– 

2742. You may inspect a copy at the 

Center for Food Safety and Applied 

Nutrition’s Library, 5100 Paint Branch 

Pkwy., College Park, MD 20740, 240– 

402–2163, or at the National Archives 

and Records Administration (NARA). 

For information on the availability of 

this material at NARA, call 202–741– 

6030, or go to http://www.archives.gov/ 

federal_register/ 

code_of_federal_regulations/ 

ibr_locations.html; or 

(3) As prescribed in Chapter 4 of the 

FDA Bacteriological Analytical Manual 

(BAM) (Edition 8, Revision A, 1998), as 

updated in June 2011. The Director of 

the Federal Register approves the 

incorporation by reference of FDA’s 

BAM, Chapter 4 (Edition 8, Revision A, 

1998), as updated in June 2011, in 

accordance with 5 U.S.C. 552(a) and 1 

CFR part 5. You may obtain a copy of 

the method from Office of Regulatory 

Science, Center for Food Safety and 

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Applied Nutrition (CFSAN), Food and 

Drug Administration, 5100 Paint Branch 

Pkwy., College Park, MD 20740, 240– 

402–1990, or you may examine a copy 

at CFSAN’s Library, 5100 Paint Branch 

Pkwy., College Park, MD, 240–402– 

2163, or at the National Archives and 

Records Administration (NARA). For 

information on the availability of this 

material at NARA, call 202–741–6030, 

or go to: http://www.archives.gov/ 

federal_register/ 

code_of_federal_regulation/ 

ibr_locations.html; or 

(4) That is at least equivalent to the 

appropriate method of analysis in 

§§ 112.151(a)(1), (a)(2) or (a)(3) in 

accuracy, precision, and sensitivity. 

§ 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? 

You must test the growing 

environment by testing for the presence 

of Listeria species or L. monocytogenes 

in environmental samples using the 

methods and procedures described in 

Chapter 10 of FDA’s Bacteriological 

Analytical Manual (BAM) April 2011, 

Edition (Edition 8, Revision A, 1998), or 

a method that is at least equivalent in 

accuracy, precision, and sensitivity. The 

Director of the Federal Register 

approves the incorporation by reference 

of FDA’s BAM, Chapter 10—‘‘Listeria 

monocytogenes, Detection and 

Enumeration of Listeria monocytogenes 

in Foods,’’ April 2011, in accordance 

with 5 U.S.C. 552(a) and 1 CFR part 5. 

You may obtain a copy of the method 

from Office of Regulatory Science, 

Center for Food Safety and Applied 

Nutrition (CFSAN), Food and Drug 

Administration, 5100 Paint Branch 

Pkwy., College Park, MD 20740, 240– 

402–1990, or you may examine a copy 

at CFSAN’s Library, 5100 Paint Branch 

Pkwy., College Park, MD, 240–402– 

2163, or at the National Archives and 

Records Administration (NARA). For 

information on the availability of this 

material at NARA, call 202–741–6030, 

or go to: http://www.archives.gov/ 

federal_register/ 

code_of_federal_regulation/ 

ibr_locations.html. 

Subpart O—Requirements Applying to 

Records That You Must Establish and 

Keep 

§ 112.161 What general requirements 

apply to records required under this part? 

(a) All records required under this 

part must: 

(1) Include, as applicable: 

(i) The name and location of your 

farm; 

(ii) Actual values and observations 

obtained during monitoring; 

(iii) An adequate description (such as 

the commodity name, or the specific 

variety or brand name of a commodity, 

and, when available, any lot number or 

other identifier) of covered produce 

applicable to the record; 

(iv) The location of a growing area (for 

example, a specific field) or other area 

(for example, a specific packing shed) 

applicable to the record; and 

(v) The date and time of the activity 

documented; 

(2) Be created at the time an activity 

is performed or observed; 

(3) Be accurate, legible, and indelible; 

and 

(4) Be dated, and signed or initialed 

by the person who performed the 

activity documented. 

(b) When records are required to be 

established and kept in subparts C, E, F, 

L, and M of this part (§§ 112.30, 112.50, 

112.60, 112.140, and 112.150), you must 

establish and keep documentation of 

actions you take when a standard in 

those subparts is not met. 

(c) Records required under 

§§ 112.50(b)(4), 112.50(b)(5), 

112.60(b)(1), 112.60(b)(3), 112.140, 

112.150(b)(1), 112.150(b)(4), and 

112.161(b), must be reviewed, dated, 

and signed, within a reasonable time 

after the records are made, by a 

supervisor or responsible party. 

§ 112.162 Where must I store records? 

(a) Offsite storage of records is 

permitted after 6 months following the 

date the record was made if such 

records can be retrieved and provided 

onsite within 24 hours of request for 

official review. 

(b) Electronic records are considered 

to be onsite at your farm if they are 

accessible from an onsite location at 

your farm. 

§ 112.163 May I use existing records to 

satisfy the requirements of this part? 

Yes. The regulations in this part do 

not require duplication of existing 

records if those records contain all of 

the information required by this part. 

§ 112.164 How long must I keep records? 

(a) You must keep records required by 

this part for 2 years past the date the 

record was created. 

(b) Records that relate to the general 

adequacy of the equipment or processes 

being used by a farm, including the 

results of scientific studies and 

evaluations, must be retained at the 

farm for at least 2 years after the use of 

such equipment or processes is 

discontinued. 

§ 112.165 What formats are acceptable for 

the records I keep? 

You must keep records as: 

(a) Original records; 

(b) True copies (such as photocopies, 

pictures, scanned copies, microfilm, 

microfiche, or other accurate 

reproductions of the original records); or 

(c) Electronic records, in compliance 

with part 11 of this chapter. 

§ 112.166 What requirements apply for 

making records available and accessible to 

FDA? 

(a) You must have all records required 

under this part readily available and 

accessible during the retention period 

for inspection and copying by FDA 

upon oral or written request, except that 

you have 24 hours to obtain records you 

keep offsite and make them available 

and accessible to FDA for inspection 

and copying. 

(b) If you use electronic techniques to 

keep records, or to keep true copies of 

records, or if you use reduction 

techniques such as microfilm to keep 

true copies of records, you must provide 

the records to FDA in a format in which 

they are accessible and legible. 

(c) If your farm is closed for a 

prolonged period, the records may be 

transferred to some other reasonably 

accessible location but must be returned 

to your farm within 24 hours for official 

review upon request. 

§ 112.167 Can records that I provide to 

FDA be disclosed to persons outside FDA? 

Records required by this part are 

subject to the disclosure requirements 

under part 20 of this chapter. 

Subpart P—Variances 

§ 112.171 Who may request a variance 

from the requirements of this part? 

A State or a foreign country from 

which food is imported into the United 

States may request a variance from one 

or more requirements of this part, where 

the State or foreign country determines 

that: 

(a) The variance is necessary in light 

of local growing conditions; and 

(b) The procedures, processes, and 

practices to be followed under the 

variance are reasonably likely to ensure 

that the produce is not adulterated 

under section 402 of the Federal Food, 

Drug, and Cosmetic Act (21 U.S.C. 342) 

and to provide the same level of public 

health protection as the requirements of 

this part. 

§ 112.172 How may a State or foreign 

country request a variance from one or 

more requirements of this part? 

To request a variance from one or 

more requirements of this part, the 

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Federal Register / Vol. 78, No. 11 / Wednesday, January 16, 2013 / Proposed Rules 3643 

competent authority (e.g., the regulatory 

authority for food safety) for a State or 

a foreign country must submit a petition 

under § 10.30 of this chapter. 

§ 112.173 What must be included in the 

Statement of Grounds in a petition 

requesting a variance? 

In addition to the requirements set 

forth in § 10.30 of this chapter, the 

Statement of Grounds in a petition 

requesting a variance must: 

(a) Provide a statement that the 

applicable State or foreign country has 

determined that the variance is 

necessary in light of local growing 

conditions and that the procedures, 

processes, and practices to be followed 

under the variance are reasonably likely 

to ensure that the produce is not 

adulterated under section 402 of the 

Federal Food, Drug and Cosmetic Act 

(21 U.S.C. 342) and to provide the same 

level of public health protection as the 

requirements of this part; 

(b) Describe with particularity the 

variance requested, including the 

persons to whom the variance would 

apply and the provision(s) of this part 

to which the variance would apply; 

(c) Present information demonstrating 

that the procedures, processes, and 

practices to be followed under variance 

are reasonably likely to ensure that the 

produce is not adulterated under section 

402 of the Federal Food, Drug, and 

Cosmetic Act (21 U.S.C. 342) and to 

provide the same level of public health 

protection as the requirements of this 

part. 

§ 112.174 What information submitted in a 

petition requesting a variance or submitted 

in comments on such a petition are publicly 

available? 

We will presume that information 

submitted in a petition requesting a 

variance and comments submitted on 

such a petition, including a request that 

a variance be applied to its similarly 

situated persons, does not contain 

information exempt from public 

disclosure under part 20 of this chapter 

and would be made public as part of the 

docket associated with this request. 

§ 112.175 Who responds to a petition 

requesting a variance? 

The Director or Deputy Directors of 

the Center for Food Safety and Applied 

Nutrition (CFSAN), or the Director, 

Office of Compliance, CFSAN, responds 

to a request for a variance. 

§ 112.176 What process applies to a 

petition requesting a variance? 

(a) In general, the procedures set forth 

in § 10.30 of this chapter govern our 

response to a petition requesting a 

variance. 

(b) Under § 10.30(h)(3) of this chapter, 

we will publish a notice in the Federal 

Register, requesting information and 

views on a filed petition, including 

information and views from persons 

who could be affected by the variance 

if the petition were to be granted (either 

because their farm is covered by the 

petition or as a person 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 Web site announcing 

our decision to either grant or deny the 

petition. 

(1) If we grant the petition, either in 

whole or in part, we will specify the 

persons to whom the variance applies 

and the provision(s) of this part to 

which the variance applies. 

(2) If we deny the petition (including 

partial denials), our written response to 

the petitioner and our public notice 

announcing our decision to deny the 

petition will explain the reason(s) for 

the denial. 

(d) We will make readily accessible to 

the public, and periodically update, a 

list of filed petitions requesting 

variances, including the status of each 

petition (for example, pending, granted, 

or denied). 

§ 112.177 Can an approved variance apply 

to any person other than those identified in 

the petition requesting that variance? 

(a) A State or a foreign country that 

believes that a variance requested by a 

petition submitted by another State or 

foreign country should also apply to 

similarly situated persons in its 

jurisdiction may request that the 

variance be applied to its similarly 

situated persons by submitting 

comments in accordance with § 10.30 of 

this chapter. These comments must 

include the information required in 

§ 112.173. If FDA determines that these 

comments should instead be treated as 

a separate request for a variance, FDA 

will notify the State 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 requesting a 

variance, in whole or in part, we may 

specify that the variance also applies to 

persons in a specific location who are 

similarly situated to those identified in 

the petition. 

(c) If we specify that the variance also 

applies to persons in a specific location 

who are similarly situated to those 

identified in the petition, we will 

inform the applicable State or foreign 

country where the similarly situated 

persons are located of our decision in 

writing and will publish a notice on our 

Web site announcing our decision to 

apply the variance to similarly situated 

persons in that particular location. 

§ 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 that the 

produce is not adulterated under section 

402 of the Federal Food, Drug and 

Cosmetic Act (21 U.S.C. 342) and to 

provide the same level of public health 

protection as the requirements of this 

part. 

§ 112.179 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 variance 

if we determine that such variance is 

not reasonably likely to ensure that the 

produce is not adulterated under section 

402 of the Federal Food, Drug, and 

Cosmetic Act (21 U.S.C. 342) and to 

provide the same level of public health 

protection as the requirements of this 

part. 

§ 112.181 What procedures apply if FDA 

determines that an approved variance 

should be modified or revoked? 

(a) We will provide the following 

notifications: 

(1) We will notify a State or a foreign 

country directly, in writing at the 

address identified in its petition, if we 

determine that a variance granted in 

response to its petition should be 

modified or revoked. Our direct, written 

notification will provide the State or 

foreign country with an opportunity to 

request an informal hearing under part 

16 of this chapter. 

(2) We will publish a notice of our 

determination that a variance should be 

modified or revoked in the Federal 

Register. This notice will establish a 

public docket so that interested parties 

may submit written submissions on our 

determination. 

(3) When applicable, we will: 

(i) Notify in writing any States or 

foreign countries where a variance 

applies to similarly situated persons of 

our determination that the variance 

should be modified or revoked; 

(ii) Provide those States or foreign 

countries with an opportunity to request 

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3644 Federal Register / Vol. 78, No. 11 / Wednesday, January 16, 2013 / Proposed Rules 

an informal hearing under part 16 of 

this chapter; and 

(iii) Include in the Federal Register 

notice described in paragraph (a)(2) of 

this section public notification of our 

decision to modify or revoke the 

variance granted to States or foreign 

countries in which similarly situated 

persons are located. 

(b) We will consider submissions 

from affected States or foreign countries 

and from other interested parties as 

follows: 

(1) We will consider requests for 

hearings by affected States or foreign 

countries under part 16 of this chapter. 

(i) If FDA grants a hearing, we will 

provide the State or foreign country 

with an opportunity to make an oral 

submission. We will provide notice on 

our Web site of the hearing, including 

the time, date, and place of hearing. 

(ii) If more than one State or foreign 

country requests an informal hearing 

under part 16 of this chapter about our 

determination that a particular variance 

should be modified or revoked, we may 

consolidate such requests (for example, 

into a single hearing). 

(2) We will consider written 

submissions submitted to the public 

docket from interested parties. 

(c) We will provide notice of our final 

decision as follows: 

(1) On the basis of the administrative 

record, FDA will issue a written 

decision, as provided for under part 16 

of this chapter. 

(2) We will publish a notice of our 

decision in the Federal Register. The 

effective date of the decision will be the 

date of publication of the notice. 

§ 112.182 What are the permissible types 

of variances that may be granted? 

Examples of permissible types of 

variances include: 

(a) Variance from the requirements, 

established in § 112.44(c), when 

agricultural water is used during 

growing operations for covered produce 

(other than sprouts) using a direct water 

application method. 

(b) Variance from the process 

conditions, established in § 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 interval, established in 

§ 112.56(a)(1), for an untreated 

biological soil amendment of animal 

origin; and 

(e) Variance from the minimum 

application interval, established in 

§ 112.56(a)(4), for a biological soil 

amendment of animal origin treated 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? 

The criteria and definitions in this 

part apply in determining whether a 

food is adulterated: 

(a) Within the meaning of section 

402(a)(3) of the Federal Food, Drug, and 

Cosmetic Act (21 U.S.C. 342(a)(3)) in 

that the food has been grown, harvested, 

packed, or held under such conditions 

that it is unfit for food; or 

(b) Within the meaning of section 

402(a)(4) of the Federal Food, Drug, and 

Cosmetic Act in that the food has been 

prepared, packed, or held under 

insanitary conditions whereby it may 

have become contaminated with filth, or 

whereby it may have been rendered 

injurious to health. The criteria and 

definitions in this part also apply in 

determining whether a food is in 

violation of section 361 of the Public 

Health Service Act (42 U.S.C. 264). 

§ 112.192 What is the result of a failure to 

comply with this part? 

The failure to comply with the 

requirements of this part, issued under 

section 419 of the Federal Food, Drug, 

and Cosmetic Act (21 U.S.C. 350h), is a 

prohibited act under section 301(vv) of 

the Federal Food, Drug, and Cosmetic 

Act (21 U.S.C. 331(vv)). 

§ 112.193 What are the provisions for 

coordination of education and 

enforcement? 

Under Section 419(b)(2)(A) of the 

Federal Food, Drug, and Cosmetic Act 

(21 U.S.C. 350h(b)(2)(A)), FDA 

coordinates education and enforcement 

activities by State, Territorial, tribal, and 

local officials. 

Subpart R—Withdrawal of Qualified 

Exemption 

§ 112.201 Under what circumstances can 

FDA withdraw a qualified exemption in 

accordance with the requirements of 

§ 112.5? 

We may withdraw your qualified 

exemption under § 112.5: 

(a) In the event of an active 

investigation of a foodborne illness 

outbreak that is directly linked to your 

farm; or 

(b) If we determine that it is necessary 

to protect the public health and prevent 

or mitigate a foodborne illness outbreak 

based on conduct or conditions 

associated with your farm that are 

material to the safety of the food that 

would otherwise be covered produce 

grown, harvested, packed or held at 

your farm. 

§ 112.202 What procedure will FDA use to 

withdraw an exemption? 

(a) If FDA determines that a qualified 

exemption applicable 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 Compliance in the Center for 

Food Safety and Applied Nutrition), or 

an FDA official senior to such Director, 

must approve an order to withdraw the 

exemption. 

(c) FDA must issue an order to 

withdraw the exemption to the owner, 

operator, or agent in charge of the farm. 

(d) FDA must issue an order to 

withdraw the exemption in writing, 

signed and dated by the officer or 

qualified employee of FDA who is 

issuing the order. 

§ 112.203 What information must FDA 

include in an order to withdraw a qualified 

exemption? 

An order to withdraw a qualified 

exemption applicable to a farm under 

§ 112.5 must include the following 

information: 

(a) The date of the order; 

(b) The name, address and location of 

the farm; 

(c) A brief, general statement of the 

reasons for the order, including 

information relevant to: 

(1) An active investigation of a 

foodborne illness outbreak that is 

directly linked to the farm; or 

(2) Conduct or conditions associated 

with a farm that are material to the 

safety of the food that would otherwise 

be covered produce grown, harvested, 

packed and held at such farm. 

(d) A statement that the farm must 

comply with subparts B through O of 

this part on the date that is 60 calendar 

days after the date of the order; 

(e) The text of section 419(f) of the 

Federal Food, Drug, and Cosmetic Act 

(21 U.S.C. 350(f)) and of this subpart; 

(f) A statement that any informal 

hearing on an appeal of the order must 

be conducted as a regulatory hearing 

under part 16 of this chapter, with 

certain exceptions described in 

§ 112.208; 

(g) The mailing address, telephone 

number, email address, and facsimile 

number of the FDA district office and 

the name of the FDA District Director in 

whose district the farm is located (or for 

foreign farms, the same information for 

the Director of the Office of Compliance 

in the Center for Food Safety and 

Applied Nutrition); and 

(h) The name and the title of the FDA 

representative who approved the order. 

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Federal Register / Vol. 78, No. 11 / Wednesday, January 16, 2013 / Proposed Rules 3645 

§ 112.204 What must I do if I receive an 

order to withdraw a qualified exemption 

applicable to my farm? 

The owner, operator, or agent in 

charge of a farm that receives an order 

to withdraw a qualified exemption 

applicable to that farm under § 112.5 

must either: 

(a) Comply with applicable 

requirements of this part within 60 

calendar days of the date of the order or, 

if operations have ceased and will not 

resume within 60 calendar days, before 

the beginning of operations in the next 

growing season; or 

(b) Appeal the order within 10 

calendar days of the date of the order in 

accordance with the requirements of 

§ 112.206. 

§ 112.205 Can I appeal or request a 

hearing on an order to withdraw a qualified 

exemption applicable to my farm? 

(a) Submission of an appeal, 

including submission of a request for an 

informal hearing, will not operate to 

delay or stay any administrative action, 

including enforcement action by FDA, 

unless the Commissioner of Food and 

Drugs, as a matter of discretion, 

determines that delay or a stay is in the 

public interest. 

(b) If the owner, operator, or agent in 

charge of the farm appeals the order, 

and FDA confirms the order, the owner, 

operator, or agent in charge of the farm 

must comply with applicable 

requirements of this part within 60 

calendar days of the date of the order, 

or, if operations have ceased and will 

not resume within 60 calendar days, 

before the beginning of operations in the 

next growing season. 

§ 112.206 What is the procedure for 

submitting an appeal? 

(a) To appeal an order to withdraw a 

qualified exemption applicable to a farm 

under § 112.5, the owner, operator, or 

agent in charge of the farm must: 

(1) Submit the appeal in writing to the 

FDA District Director in whose district 

the farm is located (or in the case of a 

foreign farm, the Director of the Office 

of Compliance in the Center for Food 

Safety and Applied Nutrition), at the 

mailing address, email address, or 

facsimile number identified in the order 

within 10 calendar days of the date of 

the order; and 

(2) Respond with particularity to the 

facts and issues contained in the order, 

including any supporting 

documentation upon which the owner, 

operator or agent in charge of the farm 

relies. 

(b) In a written appeal of the order 

withdrawing an exemption provided 

under § 112.5, the owner, operator, or 

agent in charge of the farm may include 

a written request for an informal hearing 

as provided in § 112.207. 

§ 112.207 What is the procedure for 

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 denied, in whole or in part, if 

the presiding officer determines that no 

genuine and substantial issue of 

material fact has been raised by the 

material submitted. If the presiding 

officer determines that a hearing is not 

justified, a written notice of the 

determination will be given to the 

owner, operator, or agent in charge of 

the farm explaining the reason for the 

denial. 

§ 112.208 What requirements are 

applicable to an informal hearing? 

If the owner, operator or agent in 

charge of the farm requests an informal 

hearing, and FDA grants the request: 

(a) The hearing will be held within 10 

calendar days after the date the appeal 

is filed or, if applicable, within a 

timeframe agreed upon in writing by the 

owner, operator, or agent in charge of 

the farm and FDA. 

(b) The presiding officer may require 

that a hearing conducted under this 

subpart be completed within 1 calendar 

day, as appropriate. 

(c) FDA must conduct the hearing in 

accordance with part 16 of this chapter, 

except that: 

(1) The order withdrawing an 

exemption under § 112.5, rather than 

the notice under § 16.22(a) of this 

chapter, provides notice of opportunity 

for a hearing under this section and is 

part of the administrative record of the 

regulatory hearing under § 16.80(a) of 

this chapter. 

(2) A request for a hearing under this 

subpart must be addressed to the FDA 

District Director (or, in the case of a 

foreign farm, the Director of the Office 

of Compliance in the Center for Food 

Safety and Applied Nutrition) as 

provided in the order withdrawing an 

exemption. 

(3) Section 112.209, rather than 

§ 16.42(a) of this chapter, describes the 

FDA employees who preside at hearings 

under this subpart. 

(4) Section 16.60(e) and (f) of this 

chapter does not apply to a hearing 

under this subpart. The presiding officer 

must prepare a written report of the 

hearing. All written material presented 

at the hearing will be attached to the 

report. The presiding officer must 

include as part of the report of the 

hearing a finding on the credibility of 

witnesses (other than expert witnesses) 

whenever credibility is a material issue, 

and must include a proposed decision, 

with a statement of reasons. The hearing 

participant may review and comment on 

the presiding officer’s report within 2 

calendar days of issuance of the report. 

The presiding officer will then issue the 

final decision. 

(5) Section 16.80(a)(4) of this chapter 

does not apply to a regulatory hearing 

under this subpart. The presiding 

officer’s report of the hearing and any 

comments on the report by the hearing 

participant under § 112.208(c)(4) are 

part of the administrative record. 

(6) No party shall have the right, 

under § 16.119 of this chapter to 

petition the Commissioner of Food and 

Drugs for reconsideration or a stay of the 

presiding officer’s final decision. 

(7) If FDA grants a request for an 

informal hearing on an appeal of an 

order withdrawing an exemption, the 

hearing must be conducted as a 

regulatory hearing under regulation in 

accordance with part 16 of this chapter, 

except that § 16.95(b) does not apply to 

a hearing under this subpart. With 

respect to a regulatory hearing under 

this subpart, the administrative record 

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 

proceeding consists of the record of the 

hearing and the presiding officer’s final 

decision. 

§ 112.209 Who is the presiding officer for 

an appeal and for an informal hearing? 

The presiding officer for an appeal, 

and for an informal hearing, must be an 

FDA Regional Food and Drug Director 

or another FDA official senior to an FDA 

District Director. 

§ 112.210 What is the timeframe for 

issuing a decision on an appeal? 

(a) If the owner, operator, or agent in 

charge of a farm appeals the order 

without requesting a hearing, the 

presiding officer must issue a written 

report that includes a final decision 

confirming or revoking the withdrawal 

by the 10th calendar day after the 

appeal is filed. 

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3646 Federal Register / Vol. 78, No. 11 / Wednesday, January 16, 2013 / Proposed Rules 

(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 

(2) If FDA denies the request for a 

hearing, the presiding officer must issue 

a final decision on the appeal 

confirming or revoking the withdrawal 

within 10 calendar days after the date 

the appeal is filed. 

§ 112.211 When is an order to withdraw a 

qualified exemption applicable to a farm 

revoked? 

An order to withdraw a qualified 

exemption applicable to a farm under 

§ 112.5 is revoked if: 

(a) The owner, operator, or agent in 

charge of the farm appeals the order and 

requests an informal hearing, FDA 

grants the request for an informal 

hearing, and the presiding officer does 

not confirm the order within the 10 

calendar days after the hearing, or issues 

a decision revoking the order within 

that time; or 

(b) The owner, operator, or agent in 

charge of the farm appeals the order and 

requests an informal hearing, FDA 

denies the request for an informal 

hearing, and FDA does not confirm the 

order within the 10 calendar days after 

the appeal is filed, or issues a decision 

revoking the order within that time; or 

(c) The owner, operator, or agent in 

charge of the farm appeals the order 

without requesting an informal hearing, 

and FDA does not confirm the order 

within the 10 calendar days after the 

appeal is filed, or issues a decision 

revoking the order within that time. 

(d) Confirmation of a withdrawal 

order by the presiding officer is 

considered a final Agency action for 

purposes of 5 U.S.C. 702. 

Dated: January 3, 2013. 

Leslie Kux, 

Assistant Commissioner for Policy. 

[FR Doc. 2013–00123 Filed 1–4–13; 11:15 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Parts 1, 16, 106, 110, 114, 117, 

120, 123, 129, 179, and 211 

[Docket No. FDA–2011–N–0920] 

RIN 0910–AG36 

Current Good Manufacturing Practice 

and Hazard Analysis and Risk-Based 

Preventive Controls for Human Food 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Proposed rule. 

SUMMARY: The Food and Drug 

Administration (FDA) is proposing to 

amend its regulation for Current Good 

Manufacturing Practice In 

Manufacturing, Packing, or Holding 

Human Food (CGMPs) to modernize it 

and to add requirements for domestic 

and foreign facilities that are required to 

register under the Federal Food, Drug, 

and Cosmetic Act (the FD&C Act) to 

establish and implement hazard 

analysis and risk-based preventive 

controls for human food. FDA also is 

proposing to revise certain definitions 

in FDA’s current regulation for 

Registration of Food Facilities to clarify 

the scope of the exemption from 

registration requirements provided by 

the FD&C Act for ‘‘farms.’’ FDA is taking 

this action as part of its announced 

initiative to revisit the CGMPs since 

they were last revised in 1986 and to 

implement new statutory provisions in 

the FD&C Act. The proposed rule is 

intended to build a food safety system 

for the future that makes modern, 

science-, and risk-based preventive 

controls the norm across all sectors of 

the food system. 

DATES: Submit either electronic or 

written comments on the proposed rule 

by May 16, 2013. Submit comments on 

information collection issues under the 

Paperwork Reduction Act of 1995 by 

February 15, 2013, (see the ‘‘Paperwork 

Reduction Act of 1995’’ section of this 

document). 

ADDRESSES: You may submit comments, 

identified by Docket No. FDA–2011–N– 

0920 and/or RIN 0910–AG36, 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: 

• FAX: 301–827–6870. 

• Mail/Hand delivery/Courier (for 

paper or CD–ROM submissions): 

Division of Dockets Management (HFA– 

305), Food and Drug Administration, 

5630 Fishers Lane, rm. 1061, Rockville, 

MD 20852. 

Instructions: All submissions received 

must include the Agency name and 

Docket No. for this rulemaking. All 

comments received may be posted 

without change to http:// 

www.regulations.gov, including any 

personal information provided. For 

additional information on submitting 

comments, see the ‘‘Comments’’ heading 

of the SUPPLEMENTARY INFORMATION

section of this document. 

Docket: For access to the docket to 

read background documents or 

comments received, go to http:// 

www.regulations.gov and insert the 

docket number, found in brackets in the 

heading of this document, into the 

‘‘Search’’ box and follow the prompts 

and/or go to the Division of Dockets 

Management, 5630 Fishers Lane, rm. 

1061, Rockville, MD 20852. 

FOR FURTHER INFORMATION CONTACT: 

With regard to the proposed rule: Jenny 

Scott, Center for Food Safety and 

Applied Nutrition (HFS–300), Food and 

Drug Administration, 5100 Paint Branch 

Pkwy., College Park, MD 20740, 240– 

402–2166. 

With regard to the information 

collection: Domini Bean, Office of 

Information Management, Food and 

Drug Administration, 1350 Picard Dr., 

PI50–400T, Rockville, MD 20850, 

domini.bean@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

Table of Contents 

Executive Summary 

Purpose and Coverage of the Proposed Rule 

Summary of the Major Provisions of the 

Proposed Rule 

Costs and Benefits 

I. Introduction 

II. Background 

A. Regulatory Framework for Human Food 

B. FDA Food Safety Modernization Act 

C. Preventive Controls and Hazard 

Analysis and Critical Control Points 

(HACCP) Systems 

D. Food Safety Problems Associated With 

Manufacturing, Processing, Packing, and 

Holding Food for Human Consumption 

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