Vol. 78 Wednesday, No. 11 January 16, 2013

Part II

Department of Health and Human Services

Food and Drug Administration 21 CFR Parts 1, 16, 106, Et al. Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption; Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food; Draft Qualitative Risk Assessment of Risk of Activity/Food Combinations for Activities (Outside the Farm Definition) Conducted in a Facility Co-Located on a Farm; Availability; Proposed Rules

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DEPARTMENT OF HEALTH AND issues under the Paperwork Reduction F. Current Industry Practices HUMAN SERVICES Act of 1995 must be submitted to the G. 2010 Federal Register Notice and Office of Regulatory Affairs, Office of Preliminary Stakeholder Comments Food and Drug Administration Management and Budget (OMB) (see the H. White House Food Safety Working Group ‘‘Paperwork Reduction Act of 1995’’ I. Other Related Issues 21 CFR Parts 16 and 112 section of this document). III. Legal Authority [Docket No. FDA–2011–N–0921] Electronic Submissions A. Section 105 of FSMA and Section 419 of the FD&C Act RIN 0910–AG35 Submit electronic comments in the B. Other Provisions of the FD&C Act following way: C. The Public Health Service Act Standards for the Growing, Harvesting, • Federal eRulemaking Portal: http:// D. Legal Authority for Records Packing, and Holding of Produce for www.regulations.gov. Follow the Requirements Human Consumption instructions for submitting comments. E. Intrastate Activities F. Relevance of Section 415 of the FD&C AGENCY: Food and Drug Administration, Written Submissions Act to ‘‘Farm’’ Definition and Related HHS. Definitions Submit written submissions in the ACTION: Proposed rule. IV. Regulatory Approach following ways: A. Qualitative Assessment of Risk SUMMARY: To minimize the risk of • Mail/Hand delivery/Courier (for B. Focus on Biological Hazards serious adverse health consequences or paper or CD–ROM submissions): C. Consideration of Differing Risk of death from consumption of Division of Dockets Management (HFA– Different Commodities and Practices contaminated produce, the Food and 305), Food and Drug Administration, D. Framework of the Rule 5630 Fishers Lane, rm. 1061, Rockville, E. Records Drug Administration (FDA) is proposing F. Farm-specific Food Safety Plans to establish science-based minimum MD 20852. G. Foreign Farms standards for the safe growing, Instructions: All submissions received H. Consistency With Codex Guidelines harvesting, packing, and holding of must include the Agency name and I. Product Testing as a Strategy to Control produce, meaning fruits and vegetables Docket No. FDA–2011–N–0921 and Pathogens grown for human consumption. FDA is Regulatory Information Number RIN J. Effective Dates proposing these standards as part of our 0910–AG35 for this rulemaking. All K. Compliance Dates implementation of the FDA Food Safety comments received may be posted V. The Proposal without change to http:// A. Subpart A—General Provisions Modernization Act (FSMA). These B. Subpart B—General Requirements standards would not apply to produce www.regulations.gov, including any C. Subpart C—Standards Directed to that is rarely consumed raw, produce for personal information provided. For Personnel Qualifications and Training personal or on-farm consumption, or additional information on submitting D. Subpart D—Standards Directed to produce that is not a raw agricultural comments, see the ‘‘Comments’’ heading Health and Hygiene commodity. In addition, produce that of the SUPPLEMENTARY INFORMATION E. Subpart E—Standards Directed to receives commercial processing that section of this document. Agricultural Water adequately reduces the presence of Docket: For access to the docket to F. Subpart F—Standards Directed to read background documents or Biological Soil Amendments of Animal microorganisms of public health Origin and Human Waste significance would be eligible for comments received, go to http:// G. Reserved exemption from the requirements of this www.regulations.gov and insert the H. Reserved rule. The proposed rule would set forth docket number(s), found in brackets in I. Subpart I—Standards Directed to procedures, processes, and practices the heading of this document, into the Domesticated and Wild Animals that minimize the risk of serious adverse ‘‘Search’’ box and follow the prompts J. Reserved health consequences or death, including and/or go to the Division of Dockets K. Subpart K—Standards Directed to those reasonably necessary to prevent Management, 5630 Fishers Lane, rm. Growing, Harvesting, Packing and 1061, Rockville, MD 20852. Holding Activities the introduction of known or reasonably L. Subpart L—Standards Directed to foreseeable biological hazards into or FOR FURTHER INFORMATION CONTACT: Equipment, Tools, Buildings, and onto produce and to provide reasonable Samir Assar, Center for Food Safety and Sanitation assurances that the produce is not Applied Nutrition (HFS–317), Food and M. Subpart M—Standards Directed to adulterated on account of such hazards. Drug Administration, 5100 Paint Branch Sprouts We expect that the proposed rule, if Pkwy., College Park, MD 20740, 240– N. Subpart N—Analytical Methods finalized as proposed, would reduce 402–1636. O. Subpart O—Requirements Applying to foodborne illness associated with the Records That You Must Establish and SUPPLEMENTARY INFORMATION: Keep consumption of contaminated produce. Table of Contents P. Subpart P—Variances DATES: Submit either electronic or Q. Subpart Q—Compliance and written comments on the proposed rule Enforcement Executive Summary R. Subpart R—Withdrawal of Qualified by May 16, 2013. Submit comments on Proposed Rule Exemption information collection issues under the I. Introduction VI. Preliminary Regulatory Impact Analysis Paperwork Reduction Act of 1995 by A. Contamination With Microbiological VII. Analysis Of Environmental Impact February 15, 2013 (see the ‘‘Paperwork Hazards VIII. Federalism B. Contamination With Chemical, Physical Reduction Act of 1995’’ section of this IX. Comments or Radiological Hazards document). X. References II. Efforts To Address Produce Safety ADDRESSES: You may submit comments, A. Inspections and Investigations Executive Summary identified by Docket No. FDA–2011–N– B. Guidance Documents and Letters to 0921 and/or Regulatory Information Industry The FDA Food Safety Modernization Number RIN 0910–AG35, by any of the C. Produce Safety Action Plan Act (FSMA) (Pub. L. 111–353) requires following methods, except that D. Public Hearings FDA to publish a notice of proposed comments on information collection E. Partnerships and Collaborations rulemaking to establish science-based

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minimum standards for the safe qualified end-user is either (a) the believe that the water is not safe and of production and harvesting of those consumer of the food or (b) a restaurant adequate sanitary quality for its types of fruits and vegetables that are or retail food establishment that is intended use, including requirements raw agricultural commodities for which located in the same State as the farm or for treating such water and monitoring we have determined such standards not more than 275 miles away. Instead, its treatment (proposed § 112.43); minimize the risk of serious adverse these farms would be required to Æ Establish specific requirements for health consequences or death. Further, include their name and complete the quality of agricultural water that is new section 419 also requires FDA to business address either on the label of used for certain specified purposes, adopt a final regulation based on known the produce that would otherwise be including provisions requiring periodic safety risks, setting forth procedures, covered (if a label is required under the analytical testing of such water (with processes, and practices that we FD&C Act and its implementing exemptions provided for use of public determine to minimize the risk of regulations) or at the point-of-purchase. water supplies under certain specified serious adverse health consequences or This exemption may be withdrawn in conditions or treated water), and death, including those that are the event of an active investigation of an requiring certain actions to be taken reasonably necessary to prevent the outbreak that is directly linked to the when such water does not meet the introduction of known or reasonably farm, or if it is necessary to protect the quality standards (proposed §§ 112.44 foreseeable hazards into produce and to public health and prevent or mitigate an and 112.45); and provide for alternative provide reasonable assurances that outbreak based on conduct or requirements for certain provisions produce is not adulterated under section conditions on the farm that are material under certain conditions (proposed 402 of the FD&C Act. § 112.12); and to the safety of the produce. As Æ This proposed rule focuses on explained in the Preamble, these entities Require certain records, including microbiological hazards related to are either exempt from all the documentation of inspection findings, produce growing, harvesting, packing, requirements of the rule or are subject scientific data or information relied on and holding. We conducted a ‘‘Draft to a narrower set of requirements. to support the adequacy of water Qualitative Assessment of Risk to Public treatment methods, treatment Health from On-Farm Contamination of Summary of the Major Provisions of the monitoring results, water testing results, Produce’’ and considered the findings of Regulatory Action and scientific data or information relied this assessment in developing this The proposed rule would establish on to support any permitted alternatives proposed rule. While we acknowledge science-based minimum standards for to requirements (proposed § 112.50). • the potential for chemical, physical or the safe growing, harvesting, packing, Biological Soil Amendments Æ radiological contamination of produce, and holding of produce on farms. We Establish requirements for for reasons discussed in this proposed propose new standards in the following determining the status of a biological rule, we are not proposing specific major areas: soil amendment of animal origin as standards for these hazards in this • Worker Training and Heath and treated or untreated, and for their rulemaking. Hygiene handling, conveying, and storing Æ Establish qualification and training (proposed §§ 112.51, 112.52) Æ Scope of Coverage of the Proposed Rule requirements for all personnel who Prohibit the use of human waste for The proposed rule would apply to handle (contact) covered produce or growing covered produce except in both domestic and imported produce. food-contact surfaces and their compliance with EPA regulations for However, as explained in the remainder supervisors (proposed §§ 112.21, 112.22, such uses or equivalent regulatory of this document, the proposed rule and 112.23); requirements (proposed § 112.53); Æ contains several exemptions: Æ Require documentation of required Establish requirements for • The proposed rule would not apply training (proposed § 112.30); and treatment of biological soil amendments to certain specified produce Æ Establish hygienic practices and of animal origin with scientifically commodities that are rarely consumed other measures needed to prevent valid, controlled, physical and/or raw. persons, including visitors, from chemical processes or composting • The proposed rule also would not contaminating produce with processes that satisfy certain specific apply to produce that is used for microorganisms of public health microbial standards (proposed §§ 112.54 personal or on-farm consumption, or significance (proposed §§ 112.31, and 112.55); and provide for alternative that is not a raw agricultural 112.32, and 112.33). requirements for certain provisions commodity. • Agricultural Water under certain conditions (proposed • The proposed rule would provide Æ Require that all agricultural water § 112.12); an exemption for produce that receives must be of safe and sanitary quality for Æ Establish application requirements commercial processing that adequately its intended use (proposed § 112.41). and minimum application intervals for reduces the presence of microorganisms Agricultural water is defined in part as untreated and treated biological soil (e.g. a ‘‘kill step’’) as long as certain water that is intended to, or likely to, amendments of animal origin (proposed documentation is kept. contact the harvestable portion of § 112.56); and provide for alternative • The proposed rule would not cover covered produce or food-contact requirements for certain provisions farms that have an average annual value surfaces (proposed § 112.3(c)); under certain conditions (proposed of food sold during the previous three- Æ Establish requirements for § 112.12); and year period of $25,000 or less. inspection, maintenance, and follow-up Æ Require certain records, including • The proposed rule would provide a actions related to the use of agricultural documentation of application and qualified exemption and modified water, water sources, and water harvest dates relevant to application requirements for farms that meet two distribution systems associated with intervals; documentation from suppliers requirements: (1) The farm must have growing, harvesting, packing, and of treated biological soil amendments of food sales averaging less than $500,000 holding of covered produce (proposed animal origin, periodic test results, and per year during the last three years; and §§ 112.42 and 112.46); scientific data or information relied on (2) the farm’s sales to qualified end- Æ Require treatment of agricultural to support any permitted alternatives to users must exceed sales to others. A water if you know or have reason to requirements (proposed § 112.60).

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• Domesticated and Wild Animals harvesting, packing, or holding $250,000) would have four years after Æ If animals are allowed to graze or activities (proposed § 112.140). the effective date to comply; for some of • Sprouts the water requirements, they would are used as working animals in fields Æ where covered produce is grown and Establish measures that must be have six years. All other farms would under the circumstances there is a taken related to seeds or beans for have two years after the effective date to reasonable probability that grazing or sprouting (proposed § 112.141); comply; for some of the water Æ Establish measures that must be working animals will contaminate requirements, they would have four taken for the growing, harvesting, covered produce, require, at a years to comply. packing, and holding of sprouts minimum, an adequate waiting period (proposed § 112.142); Costs and Benefits between grazing and harvesting for Æ Require that you test the growing covered produce in any growing area environment for Listeria spp. or L. The baseline estimate for preventing that was grazed, and measures to monocytogenes and that you test each all illnesses associated with microbial prevent the introduction of known or production batch of spent irrigation contamination of produce covered by reasonably foreseeable hazards into or water or sprouts for E. coli O157:H7 and this proposed regulation is $1.6 billion; onto covered produce (proposed Salmonella species and take appropriate however, we do not expect that we will § 112.82); and follow-up actions (proposed §§ 112.143, eliminate all illnesses associated with Æ If under the circumstances there is 112.144, 112.145, 112.146); and covered produce. Instead, we expect a reasonable probability that animal Æ Require certain records, including that the proposed produce safety intrusion will contaminate covered documentation of your treatment of regulation will prevent some portion of produce, require monitoring of those seeds or beans for sprouting, a written this illness burden from recurring. We areas that are used for a covered activity environmental monitoring plan and estimate the number of foodborne for evidence of animal intrusion sampling plan, test results, and certain illness prevented by this regulation to immediately prior to harvest and, as methods used (proposed § 112.150). be 1.75 million, with an associated needed, during the growing season As proposed, the effective date is 60 benefit of $1.04 billion, annually. As (proposed § 112.83). days after a final rule is published, described in the Preliminary Regulatory Impact Analysis (PRIA), making a • Equipment, Tools, and Buildings however, we are providing for a longer precise estimate of the rule’s likely Æ timeline for farms to come into Establish requirements related to compliance. Small businesses (i.e., effectiveness is extremely difficult, equipment and tools that contact those subject to proposed part 112 and, because FDA has only limited data that covered produce and instruments and on a rolling basis, the average annual would establish a clear baseline controls (including equipment used in monetary value of food sold during the estimate of how contamination occurs transport), buildings, domesticated previous three-year period is no more and the likely impact of the proposed animals in and around fully-enclosed than $500,000) would have three years provisions on that baseline, with respect buildings, pest control, hand-washing after the effective date to comply; for to causing human illness. We estimate and toilet facilities, sewage, trash, some of the water requirements, they the costs of the proposed rule to be plumbing, and animal excreta (proposed would have five years. In addition, very $459.56 million annually for domestic §§ 112.121–134); and small businesses (i.e., those subject to farms, $170.62 million annually for Æ Require certain records related to proposed part 112 and, on a rolling foreign farms covered by the rule (for a the date and method of cleaning and basis, the average annual monetary grand total of $630.18 million annually), sanitizing equipment used in growing value of food sold during the previous resulting in $406.22 million annually in operations for sprouts, and in covered three-year period is no more than estimated potential net benefits.

Summary of Costs and Prevented foodborne Ill- Total benefits Total domestic Total foreign Total costs Net benefits Benefits of the Proposed nesses (in millions) costs costs (domestic + (in millions) Rule 1 (in millions) (in millions) (in millions) foreign)

Total ...... 1.75 ...... $1,036.40 $459.56 $170.62 $630.18 $406.22

Very small Small Large

Average Annual Cost per Farm ...... $4,697 $12,972 $30,566 1 As described in detail in the PRIA, data to estimate the costs and benefits of this rule are limited. Best estimates were made for both the costs and the benefits of the rule, given the data available. We request comment on these estimations, and request, in particular, data related to the amount of contamination attributable to each potential pathway of contamination, the relative effectiveness of each provision at reducing con- tamination, and data related to current industry food safety practices.

Proposed Rule enables FDA to better protect public In addition, the law gives us important I. Introduction health by helping to ensure the safety new tools to better ensure the safety of and security of the food supply. FSMA imported foods and directs us to build Each year, about 48 million enables us to focus more on preventing an integrated national food safety Americans (1 in 6) get sick, 128,000 are food safety problems rather than system in partnership with State and hospitalized, and 3,000 die from primarily reacting to problems after they local authorities. foodborne diseases, according to occur. The law also provides us with Section 105 of FSMA adds section estimates from the Centers for Disease new enforcement authorities to help us 419 to the Federal Food, Drug, and Control and Prevention. The FDA Food achieve higher rates of compliance with Cosmetic Act (FD&C Act) (21 U.S.C. Safety Modernization Act (FSMA) (Pub. prevention- and risk-based safety 350h) requiring FDA to publish a notice L. 111–353), signed into law by standards and to better respond to and of proposed rulemaking to establish President Obama on January 4, 2011, contain problems when they do occur. science-based minimum standards for

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the safe production and harvesting of radiological contaminants. investigation, inspections, and FDA those types of fruits and vegetables that Contamination of produce can occur on- Domestic and Import Field Assignments are raw agricultural commodities for farm during growing (either in an open and data from United States Department which we have determined such environment or in a fully- or partially- of Agriculture (USDA)’s Agricultural standards are necessary to minimize the enclosed building), harvesting, packing, Marketing Service (AMS) risk of serious adverse health or holding; or elsewhere along the farm- Microbiological Database program consequences or death. Further, new to-table continuum. (MDP) (Ref. 4 Ref. 5). For instance, in section 419 also requires FDA to adopt A. Contamination With Microbiological 2009, AMS tested eight types of produce a final regulation based on known safety Hazards for E. coli O157:H7, non-O157 E. coli risks, setting forth procedures, carrying shiga toxin and enterotoxin processes, and practices that we American consumers enjoy one of the genes, and Salmonella. MDP identified determine to minimize the risk of safest supplies of produce in the world. 51 samples with E. coli carrying shiga serious adverse health consequences or Over the last few decades, however, toxin genes; however only 24 of these death, including those that are problems linked to produce, including were determined to be pathogenic. MDP reasonably necessary to prevent the the associated public health identified 32 samples with Salmonella introduction of known or reasonably implications, have been reported in a confirmed by culture. The USDA AMS foreseeable hazards into produce and to number of countries worldwide. Many MDP was discontinued in 2012 and provide reasonable assurances that factors affect the occurrence of FDA is evaluating options for any future produce is not adulterated under section microbial contamination of fresh collection of similar microbiological 402 of the FD&C Act. This proposed rule produce, including worker health and data. sets forth such standards, as well as hygiene, the quality of agricultural The following commodities accounted certain exemptions from the standards, water, the use of animal manure and for 88.5% of the total produce- consistent with section 419 of the FD&C other materials of animal origin as associated outbreaks: Act. fertilizer, the presence of wild or • 34 outbreaks associated with Two additional proposed rules, with domestic animals in or near fields or sprouts, the produce safety proposed rule, will packing areas, growing and harvesting • 30 outbreaks associated with leafy be the foundation of, and central operations, and equipment and building greens such as lettuce and spinach framework for, a new food safety system sanitation. As discussed in more detail • 17 outbreaks associated with in the United States. In an below, FDA has taken several steps to tomatoes accompanying notice in this issue of the help reduce the likelihood of microbial • 14 outbreaks associated with Federal Register, FDA is publishing the contamination; significant advances melons such as cantaloupe and preventive controls proposed rule that have been made. However, in spite of honeydew would apply to human food and require these efforts, produce-associated • 10 outbreaks associated with domestic and foreign facilities that are foodborne illnesses continue. berries, such as raspberries, blueberries, required to register under the FD&C Act FDA has looked specifically at blackberries and strawberries to have written plans that identify outbreaks where the point of • 6 outbreaks associated with fresh hazards, specify the steps that will be contamination is likely to have herbs such as basil and parsley put in place to minimize or prevent happened early in the production chain, • 3 outbreaks associated with green those hazards, monitor results, and act during growing, harvesting, onions. to correct problems that arise. manufacturing, processing, packing, (Ref. 2) FDA also intends to publish the holding, or transportation (Ref. 2). Of In the FDA database, fresh-cut fruits foreign supplier verification program the total reported outbreaks and and vegetables accounted for 16.8% of (FSVP) proposed rule, which would outbreak-related illnesses linked to the total produce-related outbreaks. help ensure the safety of foods imported FDA-regulated foods between 1996 and Generally, the most likely point of into the U.S. by making importers 2010, in the FDA database, produce original contamination for the fresh-cut- accountable for verifying that the food accounted for 23.3% and 42.3%, related outbreaks, as determined by they import is produced using processes respectively. Both domestic produce FDA and its federal and state partners and procedures that achieve the same and imported produce were identified during the outbreak investigations, level of public health protection for as vehicles in these outbreaks. From appears to be during growing, harvest, imported food as required of domestic 1996 to 2010, approximately 131 packing or holding, while the growers and processors under FSMA’s produce-related reported outbreaks commodity is still in its raw agricultural new standards for produce safety and occurred, resulting in 14,132 outbreak- commodity (RAC) form, rather than preventive controls. related illnesses, 1,360 hospitalizations during manufacturing/processing of the Eating fruits and vegetables is an and 27 deaths. These outbreaks were fresh-cut product (Ref. 2). In a few important part of a healthy diet (Ref. 1). associated with approximately 20 instances, such as unwashed, field FDA is responsible for ensuring the different fresh produce commodities packed tomatoes being removed from a safety of all domestic and imported (Ref. 3). Commodities associated with warm ripening room and placed in cold fruits and vegetables consumed in the outbreaks during this time period water to firm for slicing (which may United States. We place a high priority included sprouts; leafy greens such as have promoted infiltration of pathogens) on identifying and implementing lettuce and spinach; tomatoes; melons (Ref. 6), it is possible that practices or measures that can reduce the incidence such as cantaloupe and honeydew; conditions at the fresh-cut facility of foodborne illness associated with berries such as raspberries, blueberries, contributed to the contamination event. produce and maintain a high level of blackberries, and strawberries; fresh It is possible that the way product is consumer confidence in this important herbs such as basil and parsley; and handled during processing, including food category. Produce is vulnerable to green onions as well as fresh-cut fruits mixing large batches of fresh-cut contamination with microorganisms of and vegetables. FDA also has evidence product, may spread contamination public health significance (e.g., bacteria that contamination occurs on some across a larger volume of product, and viruses that can cause disease), as produce crops at least intermittently impacting the size and scope of an well as chemical, physical, and based on sampling performed as part of outbreak associated with fresh-cut

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produce. However, there have also been associated with a chemical hazard for Food Safety Initiative or PIFSI). As part a number of very large outbreaks which there is a reasonable probability of this initiative, the President directed associated with RACs. of causing serious health problems or the Secretary of the Department of Pathogens associated with the death (Ref. 8). Current monitoring, Health and Human Services (HHS) and produce outbreaks include bacteria, regulations, and industry practice have the Secretary of the U.S. Department of viruses and parasites. Between 1996 and been sufficient to keep these hazards Agriculture (USDA), in cooperation 2010, the majority of fresh produce- under control. with the agricultural community, to related outbreaks and illnesses in the Similarly, the potential public health issue guidance on good agricultural FDA database were associated with consequences of physical hazard practices (GAPs) for fresh fruits and bacterial agents (86.5%), followed by contamination (e.g. glass or metal vegetables. In October, 1998, we issued parasites (11.6%) and viruses (1.9%). fragments) in produce appear to be final guidance to industry entitled These outbreaks involved a number of relatively (Ref. 7). Rarely do the ‘‘Guide to Minimize Microbial Food pathogens, including E. coli O157:H7, E. physical hazards associated with Safety Hazards for Fresh Fruits and coli O157, Salmonella species produce suggest a risk of serious adverse Vegetables’’ (GAPs Guide) (Ref. 10). (Salmonella spp.), Listeria health consequences or death for This guide contains voluntary monocytogenes (L. monocytogenes), individuals that would consume the recommendations for good agricultural Cyclospora, Shigella sonnei, and product. In fact, between 1997 and practices (GAPs) that growers and Hepatitis A. 2011, there have been no Class I recalls packers can undertake to address In an accompanying document titled of produce associated with a physical common factors contributing to ‘‘Draft Qualitative Assessment of Risk to hazard for which there is a reasonable contamination in their operations. The Public Health from On-Farm probability of causing serious health GAPs Guide is a broad scope guidance Contamination of Produce,’’ FDA has problems or death (Ref. 8). that takes into account the diversity of conducted a qualitative assessment of The presence of radiological hazards conditions and practices associated with risk associated with growing, in foods is a rare event and consumer the growing, harvesting, packing and harvesting, packing, and holding of exposure to harmful levels of holding of fresh produce. We noted that produce (hereafter referred to as the radionuclide hazards, outside of firms should use the general Qualitative Assessment of Risk (QAR)). catastrophic events, is very low (Ref. 7. recommendations in the GAPs Guide to In particular, the QAR is intended to Ref. 9). tailor practices to their individual address various risk management While we acknowledge the potential operations. As the GAPs Guide notes, questions related to biological hazards for chemical, physical or radiological current technologies cannot eliminate of concern in fresh produce that can contamination of produce, based on our all potential food safety hazards lead to serious adverse health analysis (Ref. 7), and for the reasons associated with fresh produce that will consequences or death; potential routes discussed in section IV.B of this be eaten raw. Therefore, the focus of the of contamination; and the likelihood of document, we are not proposing specific GAPs Guide is on implementing contamination and likelihood of illness standards for these hazards in this measures to minimize the potential for attributable to consumption among rulemaking. introduction of such hazards. various types of produce commodities. The findings of this qualitative II. Efforts to Address Produce Safety On September 2, 2008, we issued a assessment of risk informed our notice in the Federal Register (73 FR FDA and others have taken a number 51306) requesting comments and regulatory approach and several of actions to address produce safety in proposed provisions. We provide a scientific data and information to assist the last two decades. This section us in improving the GAPs Guide. We summary of the findings in section IV; describes several of these activities up additionally, we refer to the QAR specifically asked for information about to and including FSMA. throughout this proposed rule, (1) current agricultural practices and including the discussion of proposed A. Inspections and Investigations conditions used to produce, harvest, pack, cool, and transport fresh produce; provisions in section V of this We have conducted a number of document. (2) risk factors for contamination of inspections and investigations that have fresh produce associated with these B. Contamination With Chemical, provided useful information about the practices; and (3) possible Physical or Radiological Hazards routes of contamination. Investigations recommendations or additional Chemical contaminants of produce involved visiting multiple field measures that would enhance the safety can originate from a variety of sources. locations and packing operations. of fresh produce. We also requested Most common among these include soil Observations during the investigations information about the estimated costs (through previous chemical exposure), revealed several areas of farm practices and benefits of current practices and/or equipment (e.g., lubricants, fuels, and that seem most likely to have been the cost and benefits of any refrigerants), pesticides, insecticides possible routes of contamination for recommendations. We received and related agents, and cleaning produce involved in the outbreaks. Our approximately two dozen submissions compounds (e.g., sanitizers) normally inspections, investigations, and from organizations and individuals, used in the course of maintaining surveillance sampling activities are including: Industry, government, buildings and equipment. FDA monitors described in more detail in universities, environmental groups, chemical and pesticide residues in accompanying documents. consumers, and consumer groups. A foods through its regulatory monitoring B. Guidance Documents and Letters to number of comments discussed the programs with emphasis on raw Industry value of performing operational agricultural commodities (RACs) and assessments, developing food safety foods consumed by infants and 1. GAPs Guide plans and record keeping but suggested children. Illnesses attributable to On October 2, 1997, President Clinton that any updated guidance acknowledge chemical hazards are rare (Ref. 7). In announced the ‘‘Initiative to Ensure the that these activities should be fact, between 1997 and 2011, there have Safety of Imported and Domestic Fruits commensurate with the complexity of been no Class I recalls of produce and Vegetables’’ (Produce and Imported an operation and associated risks. Other

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comments requested additional parties involved in the production of comments stated that any information on microbial testing to sprouts (i.e., producers, conditioners, recommendations should be ensure that when testing is done it is and distributors of seeds and beans used scientifically sound, based on meaningful and cost effective. for sprouting, sprout producers) that appropriate (and feasible) expectations sprouts have been recognized as an for risk reduction, and be easy to 2. Letters to Lettuce, Tomato, and important cause of foodborne illness understand and implement. Comments Cilantro Industries and to provide recommendations for expressed concern about the effect on On February 5, 2004, we issued a preventive controls that we believed worker health of treating seed with letter to firms that grow, harvest, pack should be taken immediately to reduce 20,000 ppm calcium hypochlorite. or hold fresh lettuce and fresh tomatoes, the likelihood of sprouts serving as a Comments were generally supportive of expressing concern regarding outbreaks vehicle for foodborne illness (Ref. recommendations in the Sprout Guides of foodborne illness associated with the 14).(Ref. 15) The first guidance to test spent irrigation water; several consumption of these products, and document, ‘‘Reducing Microbial Food comments supported expanded testing, recommending actions to enhance the Safety Hazards for Sprouted Seeds’’ (the including seed testing by seed safety of these products (Ref. 11). On Sprout Guide), provides producers and distributors. All but one November 4, 2005, we issued a second recommendations based on the comment maintained that seeds were letter to firms that grow, harvest, pack, recommendations of the National the primary source of contamination in hold or manufacture/process fresh and Advisory Committee on Microbiological sprout-associated outbreaks. Several fresh-cut lettuce, reiterating concerns Criteria for Foods (NACMCF) (Ref. 16). comments discussed practices and about continuing outbreaks (Ref. 12). In We also released a second guidance, conditions, such as animal grazing, the November 2005 letter, we strongly ‘‘Sampling and Microbial Testing of which could contaminate seed in the encouraged applicable firms to review Spent Irrigation Water During Sprout field. One comment suggested the their current operations in light of the Production’’ (the Sprout Testing Guide), industry develop a GAPs guidance GAPs Guide, as well as other available to assist sprouters in implementing one specific to the production of seed for information regarding the reduction or of the principal recommendations in the use in sprouts. Several comments elimination of pathogens on fresh broader Sprout Guide, i.e., that supported applying Current Good produce. We encouraged firms to producers test spent irrigation water for Manufacturing Practices (CGMPs) (21 consider modifying their operations to two pathogens (Salmonella spp. and E CFR Part 110) to sprout facilities. A ensure that they were taking the coli O157:H7) before product enters number of comments cited the diversity appropriate measures to provide a safe commerce. We refer to these guidances of sprout types currently being product to the consumer. We collectively as the Sprout Guides. produced and noted this diversity of recommended that firms from the farm On April 22, 2005, we announced in products is likely to continue to grow. level through the distribution level the Federal Register (70 FR 20852) a These comments maintained it was undertake these steps. public meeting to elicit information on therefore appropriate to provide In March, 2011, we issued a letter to current science related to foodborne flexibility for individual operations to firms that grow, harvest, pack or hold illness associated with the consumption select mitigations appropriate for the fresh cilantro, expressing concern about of sprouts. The meeting notice products they produce. Comments to positive sample findings and contained a series of questions to help the 2005 Sprout Public Meeting were recommending actions to enhance the focus comments, including questions considered in this rulemaking and will safety of these products (Ref. 13). regarding: (1) Practices that may be further described when we discuss Between 2004 and March, 2011, there contribute to contamination of seeds proposed provisions specific to sprouts had been 28 confirmed Salmonella used for sprouting and intervention in section V.M. of this document. positive sample results in fresh cilantro strategies that could help prevent, On May 1, 2009, we issued a letter to in, or entering into, commerce. Samples reduce, or control contamination of suppliers and distributors of seeds and were of both U.S. and imported origin. seeds used for sprouting; (2) Whether beans used for sprouting, and sprouters, As with earlier letters to the industry, the preventive controls recommended in to make firms aware of our serious we strongly encouraged applicable firms our Sprout Guides could be improved concerns with continuing outbreaks to review their current operations in and, if so, how this might be done; (3) associated with the consumption of raw light of the GAPs Guide, as well as other What can or should be done to increase and lightly cooked sprouts and to urge available information regarding the the involvement of producers of seeds firms to review their operations in light reduction or elimination of pathogens for sprouting and seed distributors to of our Sprout Guides and other available on fresh produce. We encouraged firms ensure the safety of sprouts; (4) How, if information (Ref. 17), and to modify to consider modifying their operations at all, should the actions to improve the their operations accordingly to ensure to ensure that they were taking the safety of seeds for sprouting be they are taking appropriate measures to appropriate measures to provide a safe structured to take into account variation provide a safe product to consumers. product to the consumer. In addition, within the seed and sprout industry, We also shared a May 1, 2008, letter we encouraged these firms to assess including variations in size of from the California Department of hazards unique to the production of establishments, the types of seeds and Public Health (CDPH) to the California cilantro and to develop commodity- sprouts produced and the practices used sprout industry outlining several critical specific preventive control strategies. in production; and (5) Existing food areas of concern identified in recent We recommended that firms from the safety systems or standards (such as investigations and CDPH farm level through the distribution level international standards) that we should recommendations for controlling undertake these steps. consider as part of our efforts to hazards associated with those minimize foodborne illness associated observations (Ref. 18). 3. Guidances and Letters Regarding with the consumption of sprouts. Sprouts In general, comments expressed a 4. Draft Commodity Specific Guidances On October 27, 1999, we published a need to include the seed industry, as On August 3, 2009, we published a notice of availability (64 FR 57893) for well as the sprout industry, in efforts to notice in the Federal Register two guidance documents to inform all improve the safety of sprouts. Several announcing the availability for public

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comment of draft commodity specific of the commodities they grow. have a mechanism to verify that your guidances (CSGs) for melons (74 FR Additional comments will be discussed suppliers use good agricultural 38437), tomatoes (74 FR 38438) and when we describe proposed provisions practices, good manufacturing practices, leafy greens (74 FR 38439). The draft relevant to those comments. and other appropriate food safety practices; and (2) ensure equipment is CSGs are intended for growers, packers, 5. Guidances Regarding Nuts processors, transporters, retailers, and designed to prevent water collection. others throughout the supply chain. The On March 11, 2009, we published a While fresh-cut produce is not covered draft CSGs, if finalized, would provide notice in the Federal Register (74 FR under the scope of this proposed rule, a framework for identifying and 10598) announcing the availability for we include a reference to our guidance implementing appropriate measures to public comment of draft guidance for on fresh-cut produce as some of the minimize the likelihood of microbial industry: Measures to Address the Risk measures recommended in that contamination of tomatoes, leafy greens, for Contamination by Salmonella document are relevant to the and melons. The draft CSGs reflect both Species in Food Containing a Peanut- requirements proposed for covered commodity specific information, such Derived Product as an Ingredient. produce in this rule. Additionally, on June 29, 2009, we as recommendations for tomato B. Produce Safety Action Plan repacking, and advances in collective published a notice in the Federal thinking in broader areas, such as Register (74 FR 310308) announcing the On June 15, 2004, we published a assessing potential hazards in and near availability for public comment of draft Federal Register notice (69 FR 33393) the field before beginning production guidance for industry: Measures to announcing a public meeting to elicit and immediately before harvest, and Address the Risk for Contamination by information from stakeholders protecting and maintaining water Salmonella Species in Food Containing concerning key elements of a draft quality at its source and during a Pistachio-Derived Product As An produce safety action plan entitled distribution and use. The draft CSGs are Ingredient. These draft guidance ‘‘Produce Safety From Production to designed to complement our GAPs documents were intended for Consumption: An Action Plan to Guide and Fresh-cut Guide. On manufacturers who use a peanut- Minimize Foodborne Illness Associated November 4, 2009, we published a derived product or pistachio-derived With Fresh Produce’’ (the Produce notice in the Federal Register, product as an ingredient in a food Safety Action Plan or PSAP). We posted extending to January 4, 2010, the product. These draft guidances provide the draft PSAP on June 18, 2004 (Ref. recommendations for evaluating the 19). The draft PSAP continued the 1997 comment period on the draft CSGs. We effectiveness of certain Salmonella Produce and Imported Food Safety have not yet issued these guidances in control measures. We have not yet Initiative, building on experience from final form. issued these guidances in final form. earlier efforts such as the development In developing the draft CSGs, we and implementation of the GAPs Guide, 6. Fresh-cut Guide relied heavily on existing industry inspections of farms and produce commodity specific guidelines, our On March 6, 2006, we published a packing facilities, surveillance sampling produce safety initiatives and programs, notice in the Federal Register (71 FR assignments, and investigations of lessons learned from outbreak 11209) announcing the availability on foodborne illness outbreaks. The draft investigations, and other public and our Web site of a draft Guidance for PSAP addressed all principal points private programs. We have since Industry entitled ‘‘Guide to Minimize between the farm and table where received several dozen written Microbial Food Safety Hazards of Fresh- contamination of produce could occur. comments, from industry, States, and cut Fruits and Vegetables’’ (the Fresh- It covered fresh fruit and vegetables in individuals. Comments were generally cut Guide). We received a number of their native (RAC) form and raw, supportive of the scope and objectives comments from trade associations, minimally processed products (i.e., of the draft CSGs. Comments provided consumer groups, and industry. fresh-cut produce) that have received their views on both commodity specific Comments were generally supportive of some processing to alter their form but issues (e.g., recommendations for field the draft Guide. A few comments have not been subject to a thermal packing tomatoes, water quality for included questions about our draft process that would eliminate microbial rehydrating leafy greens after harvest) definition of fresh-cut produce and hazards. The draft PSAP was not and cross-cutting issues (e.g., whether the recommendations in the intended to cover processed products management of wild animal intrusion, draft guidance were mandatory or such as juice, or agricultural products quality of water used in postharvest voluntary, in light of the mandatory other than fruits and vegetables. operations). A number of comments requirements in existing CGMPs. After considering comments received requested that we recognize different On February 25, 2008, we published from various stakeholders, in October risks may be associated with different a notice (73 FR 10037) announcing our 2004, we issued the final PSAP. In commodities within the commodity finalization and the availability of our recognition that contamination of groups covered by the CSGs, noting, for ‘‘Guide to Minimize Microbial Food produce can happen at any point in the example, that cantaloupe (not Safety Hazards of Fresh-cut Fruits and supply chain, the PSAP expands on the watermelon) have been identified as the Vegetables’’ (the Fresh-cut Guide). The areas covered by the GAPs Guide (i.e., vehicle in the majority of foodborne Fresh-cut Guidance complements the farms and packing houses) to extend to illness outbreaks associated with CGMPs in 21 CFR, Part 110 and all parts of the food supply chain from melons. A number of comments provides recommendations for a farm through retail or consumer expressed concern about potential bias framework for identifying and preparation and consumption. The of the CSG approach (i.e., separate implementing appropriate measures to PSAP does not cover frozen fruits and recommendations for different minimize the likelihood of microbial vegetables, fruit and vegetable juices, or commodities) against small farms contamination during the processing of nuts. The PSAP has four main growing a diversity of crops, especially fresh-cut produce. Examples of objectives: (1) Prevent contamination of the concern that the CSG approach recommendations for fresh-cut fresh produce with pathogens; (2) could require such farms to have processors in the Fresh-cut Guidance minimize the public health impact multiple food safety plans to cover each include: (1) Know your suppliers and when contamination of fresh produce

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occurs; (3) improve communication researchers, regulators, and industry) on guidelines have been developed or are with producers, packers, processors, available science and current in progress for a broad range of transporters, distributors, preparers, unpublished data; and an integrated, commodities, including: strawberries, consumers, and other government multidisciplinary approach to identify mushrooms, watermelon, potatoes, entities about the safety of fresh best practices not currently incorporated storage onions, and citrus. produce; and (4) facilitate and support by industry. A number of comments We provided technical assistance to research relevant to the contamination expressed concerns about the cost of the Association of Food and Drug of fresh produce. For each objective, the third party audits and lack of Officials (AFDO) to formulate a Model PSAP identifies steps or actions that standardization of such audits. Code of Practice for the Production of could contribute to the achievement of Comments also indicated a desire for Fresh Fruits and Vegetables (the Model that objective. The PSAP has training. Comments were divided on Code) (Ref. 20). This work grew out of measurable goals and outcomes, and whether we should continue to promote a request from the tomato industry in several steps outlined in the PSAP are adoption of voluntary GAPs guidance or late 2006 to address outbreaks of already in progress or have been pursue rulemaking to establish foodborne illness attributed to fresh completed. For example, we issued the mandatory requirements. Comments tomatoes. However, the AFDO Board Fresh-cut Guide and provided technical supporting mandatory requirements believed that it was also important to assistance to industry efforts to develop differed on what these requirements address GAPs in the production of a commodity specific supply chain should look like; suggestions ranged broader range of fresh fruits and guidance as part of the PSAP objective from mandatory GAPs to a Hazard vegetables. Thus, AFDO convened a regarding prevention of contamination. Analysis and Critical Control Point working group to develop a Model Code for produce safety during growing, C. Public Hearings (HACCP)-like approach, or a combination of the two. Comments were harvesting, packing and holding that On February, 27, 2007, we published in general agreement that, whatever could be considered as a model for a notice (72 FR 8750) of two public regulatory approach was chosen, it guidance and/or regulation by Federal hearings, and request for comment, on should be consistent across the United and State regulatory bodies, and for the safety of fresh produce. In that States, based on sound science, and collaboration among such parties and notice, we stated that we believe that cover a broad range of commodities the industry. The Model Code does not the measures outlined in the PSAP, the while being flexible enough to address the additional processing steps GAPs Guide, and other public and accommodate the needs of specific that may occur at a fresh-cut or other private sector actions, when commodities, regions, operations, processing facility, which is covered by implemented, can be effective in practices, and different sizes of the CGMPs in 21 CFR part 110. The reducing the likelihood of microbial operations. Model Code focuses on minimizing the contamination of fresh produce. potential for contamination of fresh However, the fact that outbreaks of D. Partnerships and Collaborations produce with pathogens. foodborne illness associated with fresh 1. Public and Private Standards Through cooperative agreement with produce continue to occur supports the Cornell University, FDA has, together need for a close examination of: The Because the GAPs Guide is voluntary, with USDA AMS, established a jointly extent to which these measures have FDA and food safety partners in the funded Produce Safety Alliance (PSA), been implemented; whether they have public and private sectors have based on the successful Seafood HACCP been effective when implemented emphasized education and outreach to Alliance for Training and Education. properly; and, what additional or industry to promote adoption of the The PSA is a public-private partnership different interventions might be guidance. Buyer requirements that that will develop and disseminate appropriate to reduce the likelihood of producers and other suppliers provide science- and risk-based training and future outbreaks. self- or third party audit verification that education programs to provide produce We held the public hearings to share they are following the GAPs Guide have farms with fundamental food safety information about recent outbreaks of further promoted adoption of the knowledge, starting in advance of this foodborne illness associated with guidance. We have worked with the proposed rule and continuing after the microbial contamination of fresh fresh produce industry since the release final rule is promulgated. The PSA produce, and to invite comments, data, of the GAPs Guide to promote its includes active participation from the and other scientific information about: recommendations and to advance the produce industry and academic Current practices used to grow, harvest, scientific knowledge applicable to institutions nationwide. The curriculum pack, hold, manufacture/process, and enhancing the safety of fresh produce. development process has already transport fresh produce; risk factors for For example, in conjunction with the started, through establishment of topic- contamination of fresh produce PSAP, we have provided technical specific working committees charged associated with these practices; and assistance to industry in developing with identifying challenges to measures FDA could take to enhance several industry commodity specific understanding and implementing GAPs the safety of fresh produce. The notice guidelines that cover the entire supply on farms. This first phase of work, in of hearings included a list of issues and chain, including commodity-specific advance of a final rule, is intended to questions to help focus comments and guidelines for melons, leafy greens, assist farms, especially small farms, in asked for scientific information and tomatoes, and green onions; these establishing appropriate food safety data. We received approximately 48 commodities together accounted for 70 measures, consistent with the GAPs submissions from industry, government, percent of the foodborne outbreaks Guide and other existing guidances, so universities, environmental groups, associated with produce between 1998 that they will be better positioned when consumers, and consumer groups. and 2009 (Ref. 3). These industry we issue a final rule establishing Recurring comments included: The guidelines were in turn helpful to us in produce safety standards under section importance of activities to promote or developing FDA’s draft commodity 419 of the FD&C Act. As this rulemaking enhance rapid, accurate traceback; specific guidances for the same progresses, the PSA materials will be strengthened coordination and commodities (see section II.B.4 of this modified, as needed, to be consistent communication between all sectors (i.e., document). Additional industry with the requirements in the rule.

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2. Foodborne Illness Investigations— process, potential contributing factors in addressed irrigation water sources (such Environmental Assessment Model this outbreak, and recommended as ponds and wells), source water and An ‘‘environmental assessment,’’ in measures firms should employ to procedures for mixing crop chemicals, the foodborne illness outbreak or food prevent similar contamination (http:// the potential impacts of weather events, contamination setting, means an www.fda.gov/Food/FoodSafety/ such as drought and flooding, and investigation that is triggered by an FoodborneIllness/ucm276247.htm). As animal proximity to growing fields. outbreak of foodborne illness or food discussed further in sections III.F and Assessments were scheduled to contamination incident with the V.A.2.b.i of this document, this coincide with tomato production and purpose of determining how the proposed rule would not apply to off- harvest seasons on the Eastern Shore of environment may have contributed to farm packing facilities such as the Virginia and in three tomato producing the introduction or transmission of packing facility associated with this regions in Florida. Where the teams observed conditions pathogens or other hazards that caused cantaloupe outbreak—such facilities would instead be subject to existing part or practices at one or more locations illness or contamination. In addition to 110 and section 418 of the FD&C Act. that might be improved, they shared our more traditional investigational However, we include the findings of those observations directly with the team approach, during this process we this environmental assessment here individual firm and also shared work collaboratively with a number of because the contributing factors are observations in general terms at a post- experts from CDC, State and local relevant to both on-farm and off-farm assessment meeting so that all interested agencies, and industry. parties could apply the findings to their In 2010, we conducted an produce packing practices. operations. For example, we identified environmental assessment in response 3. Produce Safety Initiative Assessments issues related to proximity of portable to a foodborne illness outbreak In August 2006 we launched the Leafy toilets to irrigating ponds and harvesting involving 33 cases of STEC O145 Greens Safety Initiative (LGSI), a multi- of drops at one or more locations. The infection in 5 States. While we have not year initiative which involved teams recommended that portable made a definitive determination assessments of practices and conditions toilets should be distanced from the regarding how or at what point in the at select leafy greens farms and facilities irrigation pond and policies that forbid supply chain E. coli O145 in California (Ref. 22). In the summer of the harvesting of drops should be contamination occurred, this assessment 2007, we began a multi-year Tomato strictly enforced. We also shared was important in a number of respects. Safety Initiative (TSI) to assess practices preliminary observations through other As mentioned above, we worked and conditions associated with growing venues, including a tomato research collaboratively with a number of experts and packing tomatoes on the Eastern priorities meeting in College Park from CDC, State and local agencies, and Shore of Virginia, followed by (hosted by Joint Institute for Food Safety industry. Working with this team, we assessments in three tomato growing and Applied Nutrition (JIFSAN) and the assessed potential sources of E. coli areas in Florida (Ref. 23). University of Florida’s Institute of Food O145 not just in the field of interest, but The initiatives were conducted as part and Agricultural Sciences) (JIFSAN in the larger growing area surrounding of a strategy to reduce foodborne illness 2010 (update)), a Leafy Greens Research the field of interest, along with the by focusing food safety efforts on Needs workshop hosted by United Fresh potential for E. coli O145 to be specific products, practices, and in Herndon, VA (United Fresh 2008), transported from a source in the growing areas that have been identified and as technical assistance to public surrounding area to the field where in past outbreak investigations. The and private efforts to develop new or implicated lettuce was grown. This initiatives were a collaborative effort enhanced guidances. highly collaborative, systems-based between FDA and the State health and approach allowed for the discovery of agriculture departments in California, 4. Research important environmental risk factors Virginia, and Florida, in cooperation FDA researchers have focused on that would not typically be explored by with several universities and members refining or developing methods to conventional investigation methods of the produce industry. Both initiatives detect, isolate and subtype pathogens of (Ref. 21). On December 29, 2010, we contained several important concern in produce, to enhance our posted a report, entitled ‘‘Environmental components, the most visible of which ability to analyze samples in support of Assessment: Non-O157 Shiga Toxin- was a series of assignments to the field our compliance activities. As resources Producing E. coli (STEC): Findings and to assess conditions and practices at permit, FDA scientists also directly Potential Preventive Control Strategies’’ farms and packing houses that could investigate questions about factors (Ref. 21), outlining the environmental lead to contamination and to observe contributing to produce contamination. assessment approach used in this actions taken by growers and packers in We also supported extramural research investigation, our observations and response to these conditions. Other and collaborations with other Federal tentative conclusions. important components of the initiatives agencies, academic institutions, and In 2011, we conducted an included continuing communication industry-supported entities to leverage environmental assessment in response and outreach with the industry at all research efforts, expertise, and resources to a foodborne illness outbreak points along the supply chain, (such as experimental stations for field involving a total of 139 persons infected facilitating and promoting research to research). This includes successful with any of four outbreak-associated enhance leafy green and tomato safety, collaborations with USDA on research strains of L. monocytogenes, including and strengthening collaboration of mutual interest. To fill knowledge 29 deaths, in 28 States (as of November between Federal, State, and local public gaps, thus facilitating implementation of 1, 2011). On October 19, 2011, we health officials in disease detection and any new policies, we have initiated new posted a report, entitled ‘‘Environmental response. agreements with USDA to conduct Assessment: Factors Potentially Assessments of tomato packing research in key areas such as Contributing to the Contamination of facilities covered dump tank water agricultural water and soil amendments Fresh Whole Cantaloupe Implicated in a quality parameters, employee hygiene, (Ref. 24). Specifically, FDA has Multi-State Outbreak of Listeriosis,’’ and facility cleaning and sanitation provided approximately one million providing an overview of the assessment practices. Assessments of the farms dollars to sponsor research at USDA

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ARS and to develop a produce safety an opportunity to ask questions and Guidelines for the Fresh Tomato Supply rule research network at the Western voice concerns about the potential for Chain (2006 1st Edition, 2008 2nd Center for Food Safety at University of legislation impacting the produce edition) and Commodity Specific Food California Davis. We intend these industry. We visited a total of 13 States Safety Guidelines for the Production, collaborative efforts to result in the with significant produce production in Harvest, Post-Harvest, and Valued- collection of data that may help resolve 2010. FDA and USDA technical experts, Added Unit Operations of Green Onions questions about the necessary time scientists and managers participated in (2010). In addition, other industry between application of raw manure or these meetings, and we were able to tour segments including, but not limited to contaminated water and safe harvest of large and smaller scale farms, and talk mushrooms, strawberries, watermelons, produce in key agro-ecological growing to people with practical experience in citrus, avocados, almonds, and dry bulb conditions and for key crops. Our goal production and implementing food onions developed commodity specific is for this research to result in suggested safety programs on farms. guidances. The fresh-cut produce protocols that farms could follow in We also were involved with the industry, via the International Fresh compliance with a final produce rule, Produce Safety Project (PSP), a research Produce Association, published in 1992 and for this process to be duplicated for and advocacy organization based at Food Safety Guidelines for the Fresh-cut other crops and regions as further Georgetown University and funded by Produce Industry and updated this funding is secured. This FDA sponsored the Pew Charitable Trust. The PSP publication periodically, with the 4th research was initiated to demonstrate provided four issue briefs (Ref. 26.Ref. edition being published most recently in the commitment of federal agencies to 27.Ref. 28.Ref. 29) each focused on 2001. address the needs of farmers, to provide specific aspects of produce production, 2. Produce Industry Food Safety initial data to finalize study protocols the risks they may represent, prevention Compliance Auditing for further research, and to attract and mitigation strategies to address matching funds from industry. these risks, and further research needs Shortly after the FDA GAPs Guide In partnership with academic in the area. Further, PSP held 6 regional was finalized, a number of retail institutions across the country, FDA has stakeholder discussion sessions to elicit produce buyers informed suppliers that also created four Centers of Excellence comment and reaction from the produce as a condition of sale, their produce (CoE), each housed at a university and industry, and to offer an avenue to suppliers must follow, and be third charged with specific food-safety tasks speak directly to the documents’ party audited for conformance with, the (Ref. 25). In 2008, a 5-year cooperative authors. A common message from the FDA GAPs guide (Ref. 30). In 1999 agreement was awarded to the industry during these discussions was USDA AMS began developing a GAPs University of California, Davis (UC concern about food safety and a desire and Good Handling Practices (GAP & Davis) to establish the most recent of to know how to reduce risks. Small GHP) Audit Verification Program, in these CoEs, the Western Center for Food growers and packers in particular response to requests from growers and Safety (WCFS). Through this agreement, conveyed a need for information and the Association of Fruit and Vegetable FDA has been able to leverage the technical support that would assist Inspection and Standardization resources and expertise of UC Davis to them in implementing food safety Agencies. The program, based on the study the impact of the unique practices. GAPs Guide, was piloted in 2000 and fully available later that same year. In geography and ecology of the growing E. Current Industry Practices regions of the Western United States. September 2001 the United Fresh Fruit In response to foodborne illnesses and Vegetable Association published 5. Engagement With Other Federal associated with produce in the mid guidance entitled Food Safety Auditing Agencies 1990s, the produce industry developed Guidelines: Core Elements of Good FDA regularly consults and produce safety guidance, engaged in Agricultural Practices for Fresh Fruits coordinates with other Federal agencies outreach regarding produce safety best and Vegetables to provide the basis for in the area of produce safety. Examples practices, developed compliance GAPs audits in the produce industry. In of these efforts can be found throughout auditing programs, and funded produce 2011 the United Fresh Produce this document and include collecting safety research. Association published a Harmonized GAPs Standard for use by producers and samples, sharing data, providing 1. Industry Produce Safety Best third party auditors in the fresh produce training and technical assistance to Practices Guidance industry, and research. Our partnerships industry. with USDA and CDC have been In 1997, the International Fresh-cut In 2007 leafy greens growers in particularly valuable to our efforts. Produce Association and the Western California, with the assistance of the Growers Association published USDA AMS and CDFA, developed and 6. Engagement with Industry and Voluntary Food Safety Guidelines for implemented the California Leafy Academia Fresh Produce, which provided Greens Marketing Agreement (CA We regularly engage with experts in generalized voluntary industry LGMA) (Ref. 31). The objective of the the produce industry and in academia. guidelines to minimize the potential for CA LGMA is to protect public health via These engagements serve to both contamination for fresh produce in compliance with the food safety educate the industry about our thinking, growing, packing, shipping and practices accepted by the LGMA board, activities, and expectations, and to processing operations. After FDA issued verified through mandatory government educate us about current industry our GAPs Guide, industry developed audits of members and signatories to the practices and academic efforts to commodity specific guidances for agreement by CDFA auditors trained enhance the safety of produce. various produce industry segments and licensed by USDA AMS (Ref. 31). In addition to the collaborations including: Commodity Specific Food In 2007 leafy greens growers in Arizona mentioned above, we initiated multiple Safety Guidelines for the Melon Supply also adopted a similar marketing produce industry listening sessions Chain (2005), Commodity Specific Food agreement and audit structure for their across the country prior to the passage Safety Guidelines for the Lettuce and growers (Ref. 32). At the request of of FSMA. At these sessions, we Leafy Greens Supply Chain (2006), industry, the USDA AMS in 2009 held provided local industry and academia Commodity Specific Food Safety seven hearings throughout the United

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States to solicit input from the leafy docket to obtain information about industry groups and trade associations, greens industries across the U.S. current practices and conditions for the consumer groups, environmental regarding their desire to develop a production and packing of fresh groups, academia, retail establishments, proposed national marketing agreement produce. On May 20, 2010, we extended packers and handlers, food markets and for leafy greens (74 FR 45565). A the original 90-day comment period for coops, laboratories and public health decision regarding the proposed USDA the docket until July 23, 2010 (75 FR facilities, and federal, state, local and AMS national marketing agreement for 28263). We established this docket to foreign governments. The USDA leafy greens is currently pending. provide an opportunity for interested Agricultural Marketing Service (AMS) In 2007, the Florida Legislature parties to provide information and share submitted a record of their public passed a law that provided the views that would inform the hearings related to their proposed Department of Agriculture and development of (1) safety standards for voluntary national marketing agreement Consumer Services with the authority to fresh produce at the farm and packing for leafy green vegetables (NLGMA) (74 address safety concerns related to fresh house and (2) strategies and cooperative FR 45565, September 3, 2009 and 74 FR tomatoes. Implementing regulations efforts to ensure compliance. 48423, September 23, 2009), and which became effective on July 1, 2008 In particular, we welcomed input on requested that we consider the contents (Florida Tomato Inspection Regulation these general categories: (1) Role of the of that record (which included 5G–6, 2007) adopted and incorporated good agricultural practice testimony, exhibits, and written by reference almost all of the recommendations in the GAPs Guide; arguments or briefs based on evidence recommendations in the Commodity (2) Standards for domestic and foreign received at the public hearing) in our Specific Food Safety Guidelines for the growers and packers; (3) Identification deliberations to develop safety Fresh Tomato Supply Chain, 2nd and prioritization of risk factors; (4) standards for fresh produce. A summary Edition (July 2008). Environmental assessment of hazards of general comments received is GAPs implementation and GAPs and possible pathways of presented in this section while specific audits have now become common contamination; (5) The impact of scale/ comments relevant to the issues components of purchase specifications size of growing operations on the nature addressed in this proposed rule are for produce in some market segments, and degree of possible food safety discussed in sections V.C through V.R of and have been a significant force in hazards; (6) Methods to tailor preventive this document. increasing awareness of GAPs and controls to particular hazards and promoting their implementation (Ref. conditions affecting an operation; (7) 1. Comments on Impact, Flexibility and 33). However, growers and packers who Possible approaches to tailoring Transparency sell product through direct marketing preventive controls to the scale of an Overall, a majority of stakeholders, channels, or to buyers who do not operation so that the controls achieve an including farmers, producers, include GAPs as a condition of sale, appropriate level of food safety consumers and industry, expressed may be less familiar with GAPs. protection and are feasible for a wide concern about the scope and impact of range of large and small operations; (8) regulation on the livelihoods of those 3. Produce Industry Produce Safety Coordination of produce food safety who produce food and on their ability Education Outreach practices and sustainable and/or organic to produce food in an economically- In addition to participation in the production methods; (9) Coordination of feasible manner. Most comments PSA housed at Cornell University produce food safety practices and supported a food safety system, (discussed above in section II.D. of this environmental and/or conservation grounded in science, for the production document), the produce industry goals or practices; (10) Coordination of of produce in a fair and equitable promoted adoption and implementation produce food safety practices and manner for both domestic and imports. of the recommendations in the FDA Federal, state, local and tribal Comments noted that regulations GAPs Guide through education and government statutes and regulations; developed should be science-based and outreach efforts in cooperation with the (11) Microbial testing; (12) Postharvest provide for producers to manage risks in land grant universities. The National operations and the role of the CGMPs in a manner appropriate to their GAPs Program at Cornell University, 21 CFR part 110; (13) Records and other operations. Several comments with collaborators at other land grant documentation that would be useful to maintained that risk assessments, universities, developed a series of industry and regulators in ensuring the hazard assessments, operational publications to train domestic growers safety of fresh produce; and (14) assessments and development of food and packers on the key principles of Strategies to enhance compliance. safety plans are vital tools for farmers to produce safety, including: Food Safety We further advised that information be able to demonstrate that the food Begins on the Farm: A Grower’s Guide previously submitted to the dockets safety practices they employ are (2000); Food Safety Begins on the Farm: requesting comments on the draft effective. Conversely, others questioned A Grower Self Assessment of Food commodity-specific guidances (CSGs), the need for some industry segments, Safety Risks (2003); and, Fruits, or to the docket requesting comments such as small farms or growers of ‘‘low Vegetables, and Food Safety: Health and and scientific data and information to risk’’ commodities to establish food Hygiene on the Farm (2004). These update the GAPs Guide, would be safety plans. A majority of comments publications and others developed by considered in this rulemaking and need also stated that research is needed on land grant universities throughout the not be resubmitted. Comments various issues relevant to produce United States have been used to train submitted to these dockets, i.e., dockets safety, including water quality, soil the produce industry on produce safety on the GAPs Guide update and draft amendments, animals (both wildlife and best practices. CSGs, as well as comments at the domesticated), and worker health and Sprouts Public Meeting and Produce hygiene. Comments urged the agency to F. 2010 Federal Register Notice and Safety Hearings, are discussed in tailor regulations to reflect variables Preliminary Stakeholder Comments sections II.B. and II.D. of this document. such as farm size, markets served, On February 23, 2010, we published In response to the 2010 FR notice, we growing conditions, and risk. In in the Federal Register (75 FR 8086; received about 880 comments from addition, comments highlighted the 2010 FR notice) a notice opening a consumers, farmers and producers, importance of transparency in the

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development and implementation of proposed rule. In requesting a variance, plans to work closely with Federal, food safety standards, and expressed among other things, the State or foreign State, and local agencies in that transparency provides regulators, country would submit information that, implementing the final rule. while the procedures, processes and buyers, and the public with the 3. Comments on Guidance and practices to be followed under the confidence they need to ensure that all Education reasonable and required practices have variance would be different from those been put in place and that any specific prescribed in this proposed rule, the A majority of comments also producer or packer of produce is in requested variance is reasonably likely expressed the need for guidance to compliance with required food safety to ensure that the produce is not assist stakeholders in implementing the practices. FSMA directs us to establish adulterated under section 402 of the requirements established in final science-based minimum standards for FD&C Act and provide the same level of regulations. Moreover, several produce safety. These standards are to public health protection as the comments stressed the importance of include procedures, processes, and requirements of the final regulations educational programs and incentives in practices that we determine to be (see proposed 112.173). FDA would any effective food safety system. Section 419(e) of the FD&C Act reasonably necessary to prevent the encourage consideration of these kinds of submissions. requires FDA to publish updated good introduction of known or reasonably agricultural practices and guidance for foreseeable biological, chemical, and Furthermore, in addition to soliciting comments on the proposed regulation the safe production and harvesting of physical hazards into covered produce specific types of fresh produce, in and to provide reasonable assurances through this notice, we will be holding public meetings in diverse geographic consultation with the Secretary of that produce is not adulterated under areas of the United States to provide Agriculture, representatives of State section 402 of the FD&C Act. As persons in different regions an departments of agriculture, farmer discussed in section IV below, FDA opportunity to comment, as required representatives, and various types of intends to adopt a regulatory approach under Section 419(a)(2) of the FD&C entities engaged in the production and that considers the risk posed by both the Act. harvesting or importing of fruits and commodity and relevant agronomic vegetables that are raw agricultural practices, and provides the most 2. Comments on Environmental commodities, including small appropriate balance between public Considerations businesses. In addition, section 419(e) of health protection and flexibility. We Several comments pointed out that the FD&C Act requires FDA to conduct recognize the need to incorporate there are a number of state and federal education and outreach regarding this appropriate flexibility within laws and programs that relate to guidance through public meetings in regulations to reflect the diversity of environmental stewardship, and noted diverse geographical regions. FDA commodities and associated processes, that environmental conservation and intends to provide ample opportunity practices, and conditions covered food safety are not necessarily cross- for public consultation and input and within the scope of this rule. For competing goals. Comments favored a will strive to develop stronger example, exemptions based on uniform regulatory approach among partnerships with the private sector to monetary value of food sold by the farm Federal, State, local and tribal ensure optimal use of resources. and direct farm marketing, commercial governments’ statutes and regulations, processing of commodities, and other and recommended that we consider the 4. Comments Related to Foreign criteria are reflected in proposed work of other Federal agencies, Producers subpart A. Under certain specified including the Environmental Protection A number of foreign governments conditions, qualified exemptions and Agency, the Department of Agriculture, expressed concerns with the foreign associated modified requirements in a and the Department of the Interior in producers’ ability to comply with and calendar year are also provided under developing proposed requirements for FDA’s enforcement of the regulation, proposed subpart A. In addition, produce to ensure such requirements do stressing the need for transparency. proposed § 112.12 would establish a not unnecessarily inhibit co- Some comments requested we consider framework for alternatives to certain management of food safety and convergence with existing private requirements of the rule. We realize that environmental concerns. In this regard, schemes, such as the Global Food Safety numerous differences exist among a few comments stated that while co- Initiative and Global G.A.P to avoid practices based on risk or agro- management of food safety and duplication of efforts while others urged ecological conditions and therefore sustainability may be considered, us to consider recognition of foreign alternatives to certain requirements ultimately, food safety has to be top governments’ produce safety initiatives. would be permitted when adequate and priority and it is unacceptable to sell In implementing a final rule based on documented scientific data or unsafe food to customers. this proposed rule, we intend to provide information support such alternatives. Section 419(a)(3)(D) of the FD&C Act equal treatment in the application, Similarly, proposed subpart P sets directs that this proposed rule take into compliance, and enforcement of the procedures for a State or foreign country consideration, consistent with ensuring proposed standards for foreign and to request a variance from one or more enforceable public health protection, domestic facilities. Recognizing that requirements of this part when certain conservation and environmental foreign farms in some countries may conditions are met, as required by practice standards and policies have difficulty in understanding the Section 419(c)(2) of the FD&C Act. For established by Federal natural resource rule’s applicability to them, we will example, a State or foreign country may conservation, wildlife conservation, and partner with stakeholders to identify consider that the historical performance environmental agencies. As discussed areas for outreach and technical of an industry within their jurisdiction further in Sections III.A.8 and V.I, we cooperation to achieve greater (e.g., as indicated by the consulted with several Federal agencies understanding of the proposed epidemiological record) and the in order to take into consideration provisions. combination of measures taken by that conservation and environmental Furthermore, consistent with section industry merits requesting a variance practice standards and policies 419(c)(2) of the FD&C Act, in proposed from some or all provisions of this established by those agencies. FDA also subpart P, we establish a procedure

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whereby a State or foreign country H. Other Related Issues Produce Safety, among other things, could request a variance from one or amends the FD&C Act to create a new 1. Tracking and Tracing of Produce more requirements proposed in the rule, section 419 with the same name. where the State or foreign country Our regulations in 21 CFR part 1, Section 419(a)(1)(A) of the FD&C Act determines that (1) the variance is subpart J require that persons who directs the Secretary of HHS, ‘‘in necessary in light of local growing manufacture, process, pack, transport, coordination with the Secretary of conditions; and (2) the procedures, distribute, receive, hold, or import food Agriculture and representatives of State in the United States establish and processes, and practices to be followed departments of agriculture (including maintain records identifying the with regard to the national organic under the variance are reasonably likely immediate previous sources and program established under the Organic to ensure that the produce is not immediate subsequent recipients of Foods Production Act of 1990), and in adulterated under section 402 of the food. During an outbreak of foodborne consultation with the Secretary of FD&C Act, and to provide the same level illness, these records can help Homeland Security,’’ to ‘‘publish a of public health protection as the determine the source of the food notice of proposed rulemaking to requirements of this rule (see section implicated in the outbreak. Farms are establish science-based minimum V.P. of this document). excluded from the requirements of part standards for the safe production and G. White House Food Safety Working 1, subpart J. We recently held public harvesting of those types of fruits and Group meetings to stimulate and focus a vegetables, including specific mixes or discussion about mechanisms to categories of fruits and vegetables, that In 2009, President Obama established enhance product tracing systems for are raw agricultural commodities for a White House Food Safety Working food in general (74 FR 56843; November which the Secretary has determined that Group to identify measures needed to 3, 2009) and for produce in particular such standards minimize the risk of upgrade our food safety laws for the 21st (73 FR 55115; September 24, 2008). serious adverse health consequences or Century, coordinate Federal efforts, and Section 204 of FSMA now directs us to death.’’ In addition to this broad develop short- and long-term agendas to take a variety of different actions that direction in section 419(a)(1)(A), section 419(a)(3) establishes more specific make food safer. Specific objectives of will enhance our ability to track and requirements for the content of the this workgroup included: Fostering trace foods, including to establish pilot proposed rule, including that the coordination of food safety efforts projects to explore and evaluate methods to rapidly and effectively proposed rule: throughout the government and • identify recipients of food to prevent or ‘‘[P]rovide sufficient flexibility to be ensuring laws are being adequately control a foodborne illness outbreak. applicable to various types of entities enforced to keep the American people Further efforts to enhance the tracking engaged in the production and safe from foodborne illness. The and tracing of food are outside of the harvesting of fruits and vegetables that workgroup was co-chaired by the scope of this proposed rule. are raw agricultural commodities, Secretaries of the HHS and USDA. including small businesses and entities Participating agencies included FDA, 2. Transportation of Food that sell directly to consumers, and be USDA’s Food Safety and Inspection On April 30, 2010 (75 FR 22713), we appropriate to the scale and diversity of Service (FSIS), CDC, the Department of published in the Federal Register an the production and harvesting of such Homeland Security, the Department of Advance Notice of Proposed commodities’’ (section 419(a)(3)(A)); Commerce, the Department of State, Rulemaking (ANPRM) as a first step in • ‘‘[I]nclude, with respect to growing, EPA, and several offices of the White implementing the Sanitary Food harvesting, sorting, packing, and storage House. Transportation Act of 2005 (SFTA). operations, science-based minimum SFTA requires the Secretary of HHS to standards related to soil amendments, On July 7, 2009, the workgroup issue regulations setting forth sanitary hygiene, packaging, temperature released its report ‘‘Implementing a transportation practices to be followed controls, animals in the growing area, National Public Health Approach to by shippers, carriers by motor vehicle or and water’’ (section 419(a)(3)(B)); • Food Safety: Report to the President.’’ rail vehicle, receivers, and others ‘‘[C]onsider hazards that occur This report included recommendations engaged in food transport. Section 111 naturally, may be unintentionally for a new public health-focused of FSMA directs us to promulgate introduced, or may be intentionally approach to the safety of all food based regulations to implement SFTA. We introduced, including by acts of on three core principles: (1) Prioritizing terrorism’’ (section 419(a)(3)(C)); intend to focus our efforts directed to • prevention, (2) strengthening sanitary transportation practices as a ‘‘[T]ake into consideration, surveillance and enforcement, and (3) separate rulemaking, already underway consistent with ensuring enforceable improving response and recovery. under the ANPRM. However, such public health protection, conservation Workgroup recommendations and efforts are outside of the scope of this and environmental practice standards White House directives specific to proposed rule. and policies established by Federal produce included (1) issuing natural resource conservation, wildlife III. Legal Authority commodity-specific guidances to reduce conservation, and environmental the likelihood of microbial FDA is proposing this regulation agencies’’ (section 419(a)(3)(D)); • ‘‘[I]n the case of production that is contamination in the production and under the FD&C Act as amended by certified organic, not include any distribution of tomatoes, melons, and FSMA, and the Public Health Service Act (PHS Act). requirements that conflict with or leafy greens; and (2) taking steps duplicate the requirements of the (including seeking public comment) to A. Section 105 of FSMA and Section 419 national organic program established establish required practices through of the FD&C Act under the Organic Foods Production Act regulation. The numerous steps we have On January 4, 2011, the FDA Food of 1990, while providing the same level taken in response to these directives are Safety Modernization Act (FSMA) (Pub. of public health protection as the described throughout this section. L. 111–353) was signed into law. requirements under guidance Section 105 of FSMA, Standards for documents, including guidance

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documents regarding action levels, and business, and collection of information FD&C Act]. The Secretary shall notify regulations under the FDA Food Safety (as defined in section 3502(3) of such the person requesting such variance of Modernization Act’’ (section Act), associated with such regulations’’ the reasons for the denial’’ (section 419(a)(3)(E)); and (section 419(c)(1)(C)); 419(c)(2)(C)). • ‘‘[D]efine, for purposes of [section • ‘‘[A]cknowledge differences in risk Æ ‘‘The Secretary, after notice and an 419], the terms ‘small business’ and and minimize, as appropriate, the opportunity for a hearing, may modify ‘very small business’’’ (section number of separate standards that apply or revoke a variance if the Secretary 419(a)(3)(F)). to separate foods’’ (section 419(c)(1)(D)); determines that such variance is not • Furthermore, section 419(b) of the FD&C ‘‘[N]ot require a business to hire a reasonably likely to ensure that the food Act establishes additional requirements consultant or other third party to is not adulterated under section 402 and that the final regulation: identify, implement, certify, compliance is not reasonably likely to provide the • ‘‘[P]rovide for minimum science- with these procedures, processes, and same level of public health protection as based standards for those types of fruits practices, except in the case of the requirements of the regulations and vegetables, including specific mixes negotiated enforcement resolutions that adopted under [section 419(b) of the or categories of fruits and vegetables, may require such a consultant or third FD&C Act]’’ (section 419(c)(2)(D)). that are raw agricultural commodities, party’’ (section 419(c)(1)(E); In addition, section 105(c) of FSMA • ‘‘[P]ermit States and foreign based on known safety risks, which may creates a new section 301(vv) in the countries from which food is imported include a history of foodborne illness FD&C Act (21 U.S.C. 331(vv)) to prohibit into the United States to request from outbreaks’’ (section 419(b)(1)); ‘‘[t]he failure to comply with the the Secretary variances from the • ‘‘[P]rovide for coordination of requirements under section 419 [of the requirements of the regulations, subject education and enforcement activities by FD&C Act].’’ to [section 419(c)(2) of the FD&C Act], State and local officials, as designated where the State or foreign country 1. Coordination and Consultation by the Governors of the respective States determines that the variance is Requirements or the appropriate elected State official necessary in light of local growing as recognized by State statute’’ (section Consistent with section 419(a)(1)(A) conditions and that the procedures, of the FD&C Act, FDA has coordinated 419(b)(2)(A)); and processes, and practices to be followed • ‘‘[I]nclude a description of the with the Secretary of Agriculture and under the variance are reasonably likely representatives of State departments of variance process under [section 419(c)] to ensure that the produce is not and the types of permissible variances agriculture (Ref. 34. Ref. 35) and adulterated under section 402 [of the consulted with the Secretary of the Secretary may grant’’ (section FD&C Act] and to provide the same 419(b)(2)(B)). Homeland Security regarding this level of public health protection as the proposed rule. In section 419(c), the FD&C Act requirements of the regulations adopted establishes criteria for the final under [section 419(b) of the FD&C Act]’’ 2. Definitions of Small and Very Small regulation, including that the final (section 419(c)(1)(F)); and Businesses regulation: • Establish requirements relating to Section 419(a)(3)(F) of the FD&C Act • ‘‘[S]et forth those procedures, variances, including that: requires that the regulations define the processes, and practices that the Æ ‘‘A State or foreign country from terms ‘‘small business’’ and ‘‘very small Secretary determines to minimize the which food is imported into the United business.’’ These terms are significant risk of serious adverse health States may in writing request a variance because section 419 of FSMA contains consequences or death, including from the Secretary. Such request shall provisions specific to such entities. procedures, processes, and practices describe the variance requested and • that the Secretary determines to be ‘‘With respect to small and very small present information demonstrating that businesses* * * that produce and harvest reasonably necessary to prevent the the variance does not increase the those types of fruits and vegetables that are introduction of known or reasonably likelihood that the food for which the raw agricultural commodities that the foreseeable biological, chemical, and variance is requested will be adulterated Secretary has determined are low risk and do physical hazards, including hazards that under section 402, and that the variance not present a risk of serious adverse health occur naturally, may be unintentionally provides the same level of public health consequences or death, the Secretary may introduced, or may be intentionally protection as the requirements of the determine not to include production and introduced, including by acts of regulations adopted under [section harvesting of such fruits and vegetables in terrorism, into fruits and vegetables, 419(b) of the FD&C Act]. The Secretary such rulemaking, or may modify the including specific mixes or categories of applicable requirements of regulations shall review such requests in a promulgated pursuant to [section 419]’’ fruits and vegetables, that are raw reasonable timeframe’’ (section (section 419(a)(1)(B) of the FD&C Act). agricultural commodities and to provide 419(c)(2)(A)). • ‘‘[T]he regulations promulgated under reasonable assurances that the produce Æ ‘‘The Secretary may approve a [section 419 of the FD&C Act] shall apply to is not adulterated under section 402’’ variance in whole or in part, as a small business* * * after the date that is (section 419(c)(1)(A)); appropriate, and may specify the scope 1 year after the effective date of the final • ‘‘[P]rovide sufficient flexibility to be of applicability of a variance to other regulation* * * [and] to a very small practicable for all sizes and types of similarly situated persons’’ (section business* * * after the date that is 2 years businesses, including small businesses 419(c)(2)(B)). after the effective date of the final regulation’’ such as a small food processing facility Æ ‘‘The Secretary may deny a (section 419(b)(3) of the FD&C Act). co-located on a farm’’ (section variance request if the Secretary In section V.A. of this document, we 419(c)(1)(B)); determines that such variance is not discuss our proposed definitions of • ‘‘[C]omply with chapter 35 of title reasonably likely to ensure that the food small and very small business. In 44, United States Code (commonly is not adulterated under section 402 and section IV.K. of this document, we known as the ‘Paperwork Reduction is not reasonably likely to provide the discuss our proposal to establish Act’), with special attention to same level of public health protection as compliance dates for small and very minimizing the burden (as defined in the requirements of the regulation small businesses that are three and four section 3502(2) of such Act) on the adopted under [section 419(b) of the years, respectively, after the effective

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date of the final regulation, with in specified circumstances. In sections 6. Providing Sufficient Flexibility To Be additional, more extended compliance V.A and V.R of this document, we Practicable dates for certain proposed provisions discuss proposed §§ 112.5 and 112.6, As required by section 419(a)(3)(A) related to water. FDA has tentatively and subpart R, respectively, which and (c)(1)(B), this proposed rule would decided not to exempt or modify the would implement these provisions of provide sufficient flexibility to be requirements of the proposed rule with the FD&C Act. respect to small and very small practicable for all sizes and types of businesses that produce and harvest Section 419(g) of the FD&C Act states entities engaged in the production and certain types of produce based on a ‘‘[t]his section shall not apply to harvesting of fruits and vegetables that determination that such types of produce that is produced by an are raw agricultural commodities, produce are low risk and do not present individual for personal consumption.’’ including small businesses and entities a risk of serious adverse health In section V.A. of this document, we that sell directly to consumers, and is consequences or death using the discuss proposed § 112.2(a)(2), which appropriate to the scale and diversity of discretionary authority provided by would implement this provision. the production and harvesting of such section 419(a)(1)(B). It is not necessary Section 419(h) of the FD&C Act states commodities. to use this discretionary authority in ‘‘[t]his section shall not apply to As discussed in section IV of this part because, as discussed in section activities of a facility that are subject to document, we have chosen a regulatory V.A. of this document, FDA proposes in section 418.’’ In sections III.F and approach that provides significant § 112.2 to exclude certain types of low V.A.2.b.i of this document we discuss flexibility. We propose a variety of risk produce from the coverage of this proposed § 112.4(a), which would different types of measures (including rule without regard to the business size implement this provision. GMP-type measures, numerical of the farm producing and harvesting standards, requirements to monitor and such produce. As discussed in section 4. Intentional Adulteration take action under certain circumstances, IV.C.2. of this document, these and written plans) to tailor the exclusions are based on our tentative FDA proposes to implement section requirements of the proposed rule conclusion that science-based minimum 105 of FSMA in two regulations, rather appropriately and to be practical for the standards to minimize the risk of than a single regulation that covers all diversity of farms and commodities that serious adverse health consequences or hazards relevant to produce. This would be covered by the proposed rule. death from biological hazards in these rulemaking is not intended to address Wherever possible, we have also commodities are not warranted. Another hazards ‘‘that may be intentionally attempted to fashion this regulation to reason it is not necessary to use the introduced, including by acts of be as flexible as possible to discretionary authority in section terrorism.’’ (§ 419(a)(3)(C) and (c)(1)(A) accommodate future changes in science 419(a)(1)(B) is because, as discussed in of the FD&C Act). FDA plans to and technology and the particularities of section V.A. of this document, FDA implement section 105 of FSMA local growing conditions and proposes in § 112.4 to apply this regarding such hazards in a separate commodities. As discussed in section regulation only to businesses with an rulemaking in the future, and intends to average annual monetary value of food V.B of this document, in proposed consult with the Secretary of Homeland sold during the previous three-year § 112.12, we list the specific Security in that rulemaking, as required period of more than $25,000 on a rolling requirements established in this rule for by § 419(a)(1)(A) of the FD&C Act. FDA basis, based on a tentative conclusion which we would allow alternatives to be that businesses with $25,000 or less in tentatively concludes that intentional established and used in appropriate sales do not contribute significantly to hazards likely will require different circumstances. This provision would the produce market (1.5% of covered kinds of controls and would be best provide significant flexibility by produce acres) and, therefore, to the addressed in a separate rulemaking. allowing individual farms to develop volume of production that could alternative standards suitable to their 5. Science-Based Minimum Standards operations with appropriate scientific become contaminated. Accordingly, we Related to Specific Topics tentatively conclude that imposing the support. In addition, consistent with proposed requirements on these Consistent with the provisions in sections 419(c)(1)(F) and (c)(2) of the businesses is not warranted because it Section 419(a)(3)(B) of the FD&C Act FD&C Act, in proposed subpart P, we provide for a mechanism by which a would have little measurable public that requires us to establish ‘‘science- State or a foreign country from which health impact. We note that such farms based minimum standards related to food is imported into the United States would continue to be subject to the soil amendments, hygiene, packaging, may request a variance from one or applicable requirements of the FD&C temperature controls, animals in the Act. more requirements proposed in this growing area, and water,’’ this proposed part, where the State or foreign country 3. Exemptions and Exceptions rule addresses specific topics relevant to determines that: (a) The variance is Section 419(f)(1) of the FD&C Act production and harvesting of produce necessary in light of local growing establishes an exemption from the on farms. We address standards related conditions; and (b) the procedures, requirements under section 419 based to soil amendments in subpart F; processes, and practices to be followed on average annual monetary value of the standards for hygiene in subpart D, under the variance are reasonably likely food sold directly to ‘‘qualified end- standards for animals in the growing to ensure that the produce is not users’’ (as defined in section 419(f)(4)) area in subpart I; and standards for adulterated under Section 402 of the Act as compared to all other buyers and water in subpart E. We address and to provide the same level of public average annual monetary value of all packaging as part of our proposed health protection as the requirements of food sold. Section 419(f)(2) establishes standards for harvest, packing, and this part. Proposed subpart P would requirements for consumer notifications holding activities in subpart K; and provide additional flexibility for with respect to food from exempt farms, temperature controls as part of our alternative practices to be used where and section 419(f)(3) provides that the proposed standards for agricultural appropriate to specific local growing Secretary may withdraw the exemption water in subpart E. conditions and commodities.

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7. Use of Third Parties 9. Consistency With National Organic and minimizing contact between Program covered produce and raw manure, or In accordance with section apply the raw manure in a manner that 419(c)(1)(E) of the FD&C Act, we are not In accordance with section 419(a)(3)(E), this proposed rule does not does not contact covered produce proposing to require a farm to hire a include any requirements that conflict during or after application. Doing so consultant or third party to identify, with or duplicate the requirements of would not jeopardize their compliance implement, certify, or comply with the National Organic Program. In with the requirements of the National these produce safety standards. These developing this proposed rule, we Organic Program. standards are intended to be capable of consulted with technical experts and In addition, this proposed rule would implementation by those who engage in representatives from the National establish in proposed § 112.163 that records kept for other purposes could be routine activities on the farm. As Organic Program (Ref. 34). Compliance used to satisfy the recordkeeping discussed in section II.D.1 and V.Q., with the provisions of this proposed requirements in this proposed rule. FDA has, together with USDA AMS, rule would not preclude compliance Accordingly, records kept under 7 CFR established a jointly funded Produce with the requirements for organic 205.103 for the purposes of the National Safety Alliance (PSA), a public-private certification in 7 CFR part 205. Organic Program that contain partnership that will develop and Moreover, where this proposed rule and information that would be required in disseminate science- and risk-based the National Organic Program would records under this proposed rule would training and education programs to include similar or related requirements, provide produce farms with not need to be duplicated. we propose that our requirements may Further, while not critical to our fundamental food safety knowledge. be satisfied concurrently with those of Education and outreach through conclusion regarding compliance with the National Organic Program (i.e., to section 419(a)(3)(E) of the FD&C Act, we mechanisms like PSA and other sources the extent the requirements are the note that the provisions of the proposed of information that are familiar to the same, compliance with this proposed rule are not in conflict with or produce farming community (such as rule could be achieved without duplicative of the non-binding Cooperative Extension, land grant duplication). For example, proposed recommendations of the National universities and trade associations) is § 112.54(c) would establish multiple Organic Standards Board’s Compost Tea the foundation of our intended options for composting processes used Task Force (Ref. 36). Certified organic compliance strategy. Through these to treat biological soil amendments of farms would be able to comply with the mechanisms, FDA aims to assist farmers animal origin used to grow covered provisions of this proposed rule with in gaining the food safety knowledge produce, including two options respect to their use of agricultural teas they will need to comply with the (§ 112.54(c)(1) and (2)) that are while simultaneously meeting or provisions of a final produce safety rule. consistent with the options available to exceeding the non-binding USDA-certified organic farms under the recommendations in the NOSB Compost 8. Consideration of Environmental National Organic Program regulations in Standards Tea Task Force Report. 7 CFR 205.203(c)(2). We seek comment on our approach to As required by section 419(a)(3)(D), in As another example, the National ensuring that this proposed rule does Organic Program application intervals developing these produce safety not conflict with or duplicate the for the use of raw manure as a soil standards and consistent with ensuring requirements of the National Organic amendment in 7 CFR 205.203(c)(1) are enforceable public health protection, we Program while providing the same level 90 days and 120 days before harvest, took into consideration conservation of public health protection as required depending on whether the edible and environmental practice standards under FSMA. portion of the crop contacts the soil. and policies established by Federal Proposed § 112.56(a)(1)(i) would require 10. Minimizing PRA burden natural resource conservation, wildlife a 9 month application interval for use of In implementing section 419 of the conservation, and environmental raw manure in the growing of covered FD&C Act through this proposed rule, agencies. In developing this rule, we produce when application is performed FDA has complied with chapter 35 of consulted with USDA’s National in a manner that does not contact title 44, United States code (commonly Organic Program and Natural Resources covered produce during application and known as the ‘‘Paperwork Reduction Conservation Service, U.S. Fish and minimizes the potential for contact with Act’’ (PRA)), with special attention to Wildlife Service, and the EPA to take covered produce after application. minimizing the burden (as defined in into consideration conservation and Proposed § 112.56(a)(1)(ii) would not section 3502(2) of such Act (44 U.S.C. environmental practice standards and require an application interval for use of 3502(2)) on the facility, and collection policies established by those agencies raw manure in the growing of covered of information (as defined in section (Ref. 34). Our proposed requirements produce when application is performed 3502(3) of such Act (44 U.S.C. 3502(3)), encourage the application of practices in a manner that does not contact associated with the proposed rule. that can enhance food safety, including covered produce during or after Under section 3502(2) of the PRA, sustainable conservation practices. application. For certified organic farms ‘‘burden’’ means the ‘‘time, effort, or Additionally, as discussed in section growing produce that would be subject financial resources expended by persons V.E of this document, this proposed rule to this rule, the National Organic to generate, maintain, or provide is designed to be compatible with Program application intervals would information to or for a Federal agency.’’ existing conservation practices in the run concurrently with the proposed Under section 3502(3) of the PRA, management of agricultural water application interval in this proposed ‘‘collection of information’’ means, in systems. Moreover, as discussed in rule, rather than consecutively. Organic relevant part, ‘‘the obtaining, causing to section V.I of this document, this farms (like other farms) using raw be obtained, soliciting, or requiring the proposed rule would not require the manure would either need to wait 9 disclosure to third parties or the public, destruction of habitat or the clearing of months between application and harvest of facts or opinions by or for an agency, farm borders around outdoor growing and use application methods meeting regardless of form or format, calling for areas or drainages. the proposed requirements for avoiding * * * answers to identical questions

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posed to, or identical reporting or provides that a food is adulterated if it As discussed in section II of this recordkeeping requirements imposed has been prepared, packed, or held document, without appropriate on, ten or more persons.* * *’’ In under insanitary conditions whereby it prevention steps, certain practices on section X of this document, we discuss may have become contaminated with farms can lead to the contamination of how this proposed rule complies with filth, or whereby it may have been food with pathogens, increasing the the requirements of the PRA. In rendered injurious to health. Under likelihood of foodborne illness. We addition, in implementing section 419 section 701(a) of the FD&C Act, FDA is tentatively conclude that the proposed of the FD&C Act, we have paid special authorized to issue regulations for the provisions in this document are attention to minimizing burden and efficient enforcement of the FD&C Act. necessary to prevent the spread of collection of information associated The proposed rule includes many communicable disease and to prevent with this proposed rule. requirements that are necessary to food from containing filthy, putrid, or As discussed above, we are proposing prevent food from being adulterated decomposed substances; being requirements that provide significant (either because it consists in whole or in otherwise unfit for food, or being flexibility for different sizes and types of part of a filthy, putrid, or decomposed prepared, packed, or held under farms. By making these requirements substance, because it is otherwise unfit insanitary conditions whereby it may flexible enough to be practicable for for food, or because it has been held have become contaminated with filth, or different sizes and types of farms, the under insanitary conditions whereby it whereby it may have been rendered proposed rule also avoids creating may have become contaminated with injurious to health. unnecessary information collection filth, or whereby it may have been D. Legal Authority for Records burden for entities, because farms rendered injurious to health). A Requirements should be able to tailor their regulation that requires measures to recordkeeping to their specific prevent food from being held under We are proposing to use our authority circumstances while still complying insanitary conditions whereby either of under the FD&C Act and the PHS Act to with the requirements of the proposed the proscribed results may occur allows institute certain records requirements as rule. for the efficient enforcement of the follows: • In addition, as discussed in section FD&C Act. See, e.g., regulations to For covered produce that is IV.E. of this document, the only require HACCP systems for fish and exempted from the requirements of the requirements we are proposing that fishery products (21 CFR Part 123) and proposed rule because it receives constitute collections of information are juice (part 120), regulations to require a commercial processing that adequately those that are necessary to implement safe handling statement on cartons of reduces the presence of microorganisms section 419 of the FD&C Act and for the shell eggs that have not been treated to of public health significance, the efficient enforcement of the FD&C Act. destroy Salmonella organisms and to identity of the recipient that receives We propose to require records under require refrigeration of shell eggs held this produce (§ 112.2); • this rule only in instances where for retail distribution (parts 101 and For alternatives that farms may maintenance of detailed information is 115), and regulations for the production, establish and use for certain needed to keep track of measures storage, and transportation of shell eggs requirements of the proposed rule, the directed at minimizing the risk of a (part 118). scientific data and information used to known or reasonably foreseeable support such alternatives (§ 112.12); hazards, where identification of a C. The Public Health Service Act • Documentation of compliance with pattern of problems is important to In addition to the FD&C Act, FDA’s certain requirements related to training minimizing the risk of such hazards, or legal authority for the proposed rule of personnel (§ 112.30); water where they are important to facilitate derives from the PHS Act. Authority monitoring and testing (§ 112.50); verification and compliance with under the PHS Act for the proposed biological soil amendments of animal standards and this cannot be effectively regulations is derived from the origin (§ 112.60); sanitizing of done by means other than a review of provisions of sections 311, 361, and 368 equipment used in growing operations records. These instances are discussed (42 U.S.C. 243, 264, and 271) that relate for sprouts, or for covered harvest, in more detail in section IV.E. of this to communicable disease. The PHS Act packing, or holding activities document and throughout section V of authorizes the Secretary to make and (§ 112.140), and sprouts (§ 112.150); and this document. In addition, although we enforce such regulations as ‘‘are • General requirements in subpart O recognize their value and encourage necessary to prevent the introduction, that apply to records required to be their use, we are not proposing to transmission, or spread of established and maintained. require farms to conduct operational communicable diseases from foreign As discussed further in sections V.A., assessments or to develop written food countries into the States * * * or from V.B., V.C., V.E., V.F., V.L., V.M., and safety plans akin to similar one State * * * into any other State’’ V.O. of this document, the proposed requirements for facilities subject to (section 361(a) of the PHS Act). (See sec. recordkeeping requirements are section 418 of the FD&C Act or our juice 1, Reorg. Plan No. 3 of 1966 at 42 U.S.C. necessary for covered farms to ensure HACCP or seafood HACCP regulations. 202 for transfer of authority from the their own compliance with these Surgeon General to the Secretary; see 21 aspects of the proposed rule and for B. Other Provisions of the Federal Food, CFR 5.10(a)(4) for delegation from the FDA to ensure that covered farms are Drug, and Cosmetic Act Secretary to FDA.) The provisions in the complying with the same aspects of the FDA’s authority for this proposed rule proposed rule are necessary to prevent proposed rule. Therefore, these also derives from sections 402(a)(3), food from being contaminated with proposed requirements are necessary for 402(a)(4), and 701(a) of the FD&C Act. human pathogens such as Salmonella, the efficient enforcement of the FD&C Section 402(a)(3) of the FD&C Act L. monocytogenes, and E. coli O157, Act because they will aid both farms provides that a food is adulterated if it and therefore to prevent the and FDA in ensuring that food is not consists in whole or in part of any introduction, transmission, or spread of adulterated, and are necessary to filthy, putrid, or decomposed substance, communicable disease from foreign prevent the spread of communicable or if it is otherwise unfit for food. countries into the United States, or from disease because they will aid both farms Section 402(a)(4) of the FD&C Act one state in the United States to another. and FDA in ensuring that food does not

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become contaminated with human section 301 of the FD&C Act, and because the risk presented by unsafe pathogens. section 304 of the FD&C Act (21 U.S.C. food can be great, whether or not the In addition to having the authority 334) demonstrate that Congress has food moves from one state to another. under the FD&C Act and the PHS Act to included a specific interstate commerce FDA seeks comment on the number of require this recordkeeping, we also have nexus in the provisions of the FD&C Act so-called ‘‘intrastate’’ farms that would the authority to require access to the when that is its intent. Accordingly, it not be exempt from the proposed rule records. Because the underlying is reasonable to interpret sections 419 either under the proposed exemption in requirements are necessary to minimize and 301(vv) of the FD&C Act as not § 112.5 or as a result of growing only the likelihood of adulteration and the limiting the application of the proposed produce that would be exempt under spread of communicable disease, access rule only to those farms with a direct proposed § 112.2. to records that demonstrate that a farm connection to interstate commerce. E. Relevance of Section 415 of the FD&C has followed those requirements is FDA is mindful that its interpretation essential to confirm compliance and Act to ‘‘Farm’’ Definition and Related of FSMA and the FD&C Act should not Definitions achieve the full benefits of the rule. We cast doubt on the constitutionality of Section 419 directs FDA to issue a also have the authority to copy the those statutes. (See Solid Waste Agency proposed rule ‘‘for the safe production records when necessary. We may of Northern Cook County v. U.S., 531 and harvesting’’ of certain produce. consider it necessary to copy records U.S. 159 (2001)). FDA has considered when, for example, our investigator may Section 419 does not affirmatively the relevant provisions of FSMA and the identify the businesses to which the need assistance in reviewing a certain FD&C Act, FDA’s responsibilities in record from relevant experts in proposed rule must apply, but requires implementing those statutes, and the headquarters. If we are unable to copy FDA to address ‘‘with respect to law interpreting the commerce clause of the records, we would have to rely growing, harvesting, sorting, packing, the Constitution (Article I, section 8). solely on our investigators’ notes and and storage operations * * * soil Congress’s power to legislate under the reports when drawing conclusions. In amendments, hygiene, packaging, commerce clause is very broad. addition, copying records will facilitate temperature controls, animals in the However, such power is not without follow up regulatory actions. Therefore, growing area, and water’’ (419(a)(3)(B)); limits, see United States v. Lopez, 514 we have tentatively concluded that the frequently uses the term ‘‘farm’’ (e.g., U.S. 549, 567 (1995); U.S. v. Morrison, ability to access and copy records is section 419(f)); and clarifies that section 529 U.S. 598, 618 (2000), and these necessary to enforce the rule and 419 does not apply to produce produced prevent adulteration and the spread of limits have been construed in light of by an individual for personal communicable disease. In other relevant relevant and enduring precedents. In consumption (section 419(g)) or sections of this document, we explain in particular, in Lopez, supra, the Supreme activities of facilities subject to section more detail the recordkeeping Court acknowledged the continuing 418 (section 419(h)). FDA intends to provisions that we believe are necessary vitality of Wickard v. Filburn, 317 U.S. issue a notice of proposed rulemaking and, because they are limited to what is 111 (1942), noting that ‘‘although implementing section 418 of the FD&C necessary, that we believe do not create Filburn’s own contribution to the Act (section 103 of FSMA) in the near an unreasonable recordkeeping burden. demand for wheat may have been trivial future. FDA tentatively concludes that by itself, that was not ‘enough to remove ‘‘activities of facilities subject to section F. Intrastate Activities him from the scope of Federal 418’’ are those activities triggering the FDA tentatively concludes that the regulation where, as here, his requirement to register with FDA under provisions in the proposed rule should contribution, taken together with that of section 415 of the FD&C Act (21 U.S.C. be applicable to activities that are many others similarly situated, is far 350d), ‘‘Registration of Food Facilities.’’ intrastate in character. The plain from trivial.’’’ (514 U.S. at 556.) See also FDA therefore tentatively concludes that language of section 419 of the FD&C Act Gonzales v. Raich, 545 U.S. 1, 17–25 it is reasonable to apply this proposed directs FDA to establish science-based (2005). This principle applies to the rule to farms and activities of farm minimum standards for the safe application of sections 419 and 301(vv) mixed-type facilities that are within a production and harvesting of fruit and of the FD&C Act, as added by section definition of ‘‘farm’’ consistent with that vegetable RACs to minimize the risk of 105 of FSMA. Accordingly, given the utilized in FDA’s implementation of serious adverse health consequences or collective impact on commerce of farms section 415 of the FD&C Act, except to death. Section 419 does not include a that grow, harvest, pack, or hold food the extent that such entities are limitation to interstate commerce. In that is sold in ‘‘intrastate’’ commerce, producing fruits and vegetables for their addition, the exemption provided in FDA tentatively concludes that such own consumption. In the near future, section 419(f) of the FD&C Act, based in farms should be subject to the proposed we plan to address how we will part on the proportion of a farm’s sales rule unless an exemption from the rule coordinate the definitions in the section made to restaurants or retail food applies (for example, if the farm is 415 registration regulations with the establishments intrastate or within 275 eligible for the qualified exemption in definitions we are proposing for the miles, suggests that Congress intended proposed § 112.5, or if the farm only purpose of the produce safety proposed the rule issued under section 419 to grows produce exempt from the rule. Ultimately, FDA intends that the apply to intrastate commerce because regulation under one of the exemptions activities to be regulated under this otherwise there would be no need to in proposed § 112.2). This outcome is proposed rule will not trigger the provide an exemption for farms whose consistent with section 709 of the FD&C requirement to register under section sales are intrastate in character. In Act (21 U.S.C. 379a), which states that 415 of the FD&C Act and as a result will addition, section 301(vv) of the FD&C in any action to enforce the act’s not be ‘‘activities of a facility subject to Act provides that ‘‘[t]he failure to requirements respecting foods, drugs, section 418,’’ consistent with the comply with the requirements under devices, and cosmetics, any necessary requirement in section 419(h). section 419’’, or the causing thereof, is connection with interstate commerce is Moreover, the activities within the a prohibited act. Section 301(vv) does presumed. Likewise, this outcome is definition of ‘‘farm’’ we propose as part not require an interstate commerce consistent with FSMA’s risk-based, of this rulemaking closely track those nexus. Notably, other subsections in preventive approach to food safety identified in section 419(a)(3)(B), and

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this interpretation is consistent with (4) Does the likelihood of illness Hazards of concern in produce—The section 419(f)’s use of the term ‘‘farm.’’ attributable to produce consumption scientific evidence from outbreaks, Because section 418(o)(2) of the FD&C vary among produce commodity types? surveys and published literature Act defines the term ‘‘facility’’ for the (5) What is the impact of postharvest establish that human pathogens (e.g., purposes of section 418 to mean only practices on the level of contamination Salmonella, pathogenic E.coli, Shigella, those facilities required to register under at consumption? (6) What on-farm Cyclospora) constitute a biological section 415 of the FD&C Act, FDA interventions are available to reduce the hazard with the potential to cause tentatively concludes that Congress likelihood of contamination? (Ref. 2). serious adverse health consequences or intended the exemptions from the The qualitative assessment of risk death and result in the vast majority of registration requirement set forth in document is currently being peer foodborne illness known to be section 415 and FDA’s implementing reviewed and changes can be reasonably associated with produce consumption. regulations in part 1, subpart H anticipated based on the peer review. Potential routes of contamination— (including the farm exemption in The peer review plan is available online Based on our observations during § 1.226(b)) to be meaningful for the at http://www.fda.gov/ScienceResearch/ inspections, investigations, and purposes of defining section 418’s SpecialTopics/ surveillance activities and other applicability (and in turn, section 419’s PeerReviewofScientificInformation available information, we have grouped applicability). Thus, we tentatively andAssessments/ucm079120.htm. We the possible routes of contamination conclude that activities within a will consider peer reviewers’ and public into five major pathways: Water, Soil definition of ‘‘farm’’ consistent with the comments in finalizing the qualitative amendments, Animals, Worker health definition utilized to implement the assessment and this proposed rule. and hygiene, and Equipment and section 415 registration requirement are While data and information available buildings. Seed is an additional route of not subject to section 418 of the FD&C to us at this time permitted us to contamination for sprouts. Act, but activities outside such a conduct only a qualitative (not Likelihood of contamination—All definition of ‘‘farm’’ are subject to quantitative) assessment, some produce commodities can be section 418 when they cause a facility important conclusions can be drawn, contaminated before, during, and/or to be required to register with FDA which provide a basis for our proposed after harvest through one or more of the under section 415. We discuss the science-based minimum standards for potential routes of contamination. proposed definition of ‘‘farm’’ and the safe production and harvesting of Although the likelihood of related definitions in section V.A.2.b.i produce commodities. We provide contamination varies by commodity, it of this document. We seek comment on below a brief summary of conclusions of appears to be dependent on the these interpretations. the QAR. practices employed and, to a lesser extent, on the characteristics of the IV. Regulatory Approach Key conclusions from this assessment are: commodity. There appears to be greater A. Qualitative Assessment of Risk • Produce can be contaminated with variability in the likelihood of contamination among commodities As discussed below, we are proposing biological hazards, and the vast majority during growing than during harvest or to adopt an approach that focuses on the of produce-related illnesses are after harvest. likelihood of contamination of produce associated with biological hazards. • The most likely routes of Likelihood of exposure—Subsequent posed by the agricultural practices to any contamination on-farm, applied to the crop, while exempting contamination from growing, harvesting, and on-farm postharvest consumer and retail handling practices only the lowest-risk produce. We and produce consumption rates affect conducted a qualitative assessment of activities are associated with seed (for sprouts), water, soil amendments, the likelihood that consumers will be risk (QAR) of hazards related to produce exposed to contamination. Postharvest production and harvesting. The QAR animals, worker health and hygiene, and buildings/equipment. practices such as cooking (and possibly indicated that produce commodities are certain peeling) before consumption • Although some types of produce potentially subject to similar may have an impact on the likelihood have been repeatedly associated with microbiological hazard pathways: of exposure if indeed the produce is outbreaks, all types of produce Commodities can potentially become contaminated. contaminated from, for example, direct commodities have the potential to Risk of illness—Contaminated exposure to contaminated water or soil become contaminated through one or produce has the potential to cause amendment. Therefore, we propose to more of these potential routes of illness. However, there are differences adopt a regulatory approach for contamination. • among commodities in the risk of illness minimizing the risks associated with The specific growing, harvesting, primarily based on the routes of those hazards and, as appropriate, and on-farm postharvest conditions and contamination associated with the provide flexibility for the use of practices associated with a produce commodity. alternative measures that would provide commodity influence the potential Produce commodities that are ranked the same level of public health routes of contamination and the as ‘‘higher’’ risk of illness and those protection as the proposed standard. likelihood that the given route could ranked as ‘‘lower’’ risk of illness share The QAR addressed various questions lead to contamination and illness. Use some of the same characteristics. Both related to produce safety, including: (1) of poor agricultural practices could lead categories include: What are the biological hazards of to contamination and illness, even • Crops where the harvestable portion concern in produce that can lead to where the potential for contamination is grows in the ground; serious adverse health consequences or relatively low. • Row crops where the harvestable death? (2) How does produce become • Postharvest practices such as portion grows on or near the ground; contaminated (i.e., routes of cooking (and, possibly certain peeling) • Crops where the harvestable portion contamination) during on-farm growth, before consumption may have an impact grows above the ground; harvesting, and postharvest operations? on the likelihood of contamination of • Crops where the harvestable portion (3) Does the likelihood of contamination the edible portion and the likelihood of grows on trees, high above the ground; vary among produce commodity types? illness. and

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• Crops that are generally grown is an important factor in determining apart from produce growing, harvesting, without soil. likelihood of contamination. and postharvest areas). Such diversity suggests that sorting • Commodity type (growth • Excreta from wild animals that commodities for risk based only on the characteristics, e.g. near to ground) and rarely associate with human activities manner in which commodities grow surface properties (e.g., porosity) affect poses the least likelihood of would be inappropriate. This diversity the probability and degree of contamination of produce. also characterizes commodities contamination. • Human pathogens from animal associated with outbreaks. Even within • Microbial quality of source waters, excreta, once introduced to the growing a commodity group, physical method of application, and timing of environment, can be expected to characteristics (such as texture of the application are key determinants in eventually die off; but the rate of die-off fruit) of the commodity that could alter assessing relative likelihood of is dependent upon a number of the potential for contamination and, contamination attributable to environmental, regional, and other agro- therefore, association with an outbreak, agricultural water use practices. ecological factors. do not always appear to do so. With regard to soil amendments as a With regard to worker health and In summary, some produce types are route of contamination— hygiene as a route of contamination— repeatedly associated with reported • Soil amendments can be a source of • Humans (i.e., workers and visitors) foodborne illness whereas other contamination to produce are potential carriers of foodborne produce types are only intermittently • Biological soil amendments of pathogens and can be a source of associated with foodborne illness. Still animal origin have a greater likelihood contamination of produce. other produce commodities have not of containing human pathogens than do • Individuals with communicable been associated with reported foodborne chemical or physical soil amendments diseases that can be spread via food who illness. Likely factors contributing to the or those that do not contain animal are engaged in activities in which they likelihood of contamination, exposure, waste (e.g., plant-based soil contact produce or food contact surfaces and illness include: Agricultural amendments). can result in contamination of the practices used during growing, • Human waste is the most likely produce or food-contact surfaces with harvesting, and postharvest; physical waste to contain human pathogens. human pathogens. characteristics of the crop; consumer • Animal waste subject to treatments, • Hand-washing reduces the potential and retail handling practices (such as such as chemical and physical for contamination of produce. Its cooking and peeling); and rates of treatments and composting, has efficacy varies depending upon the use consumption. However, use of poor relatively lower levels of human of soap, the quality of the water, and agricultural practices could lead to pathogens than untreated animal waste. whether or not hands are dried after • contamination and illness, even where Composting is less likely than washing. the potential for contamination is controlled chemical or physical • Dirty and damaged gloves may relatively low. treatments to fully eliminate human contaminate produce. With regard to water as a route of pathogens from animal waste. • Workers or visitors that touch contamination:— • Incompletely treated, or re- animals can contaminate produce or • Agricultural water can be a source contaminated, biological soil food contact surfaces. of contamination of produce. amendments of animal origin may also • Poor hygienic practices, e.g. lack of • Public Drinking Water Systems contain human pathogens. hand washing, can lead to (domestically regulated by the EPA) • Human pathogens in untreated or contamination of produce. have the lowest relative likelihood of composted biological soil amendments, • The presence of adequate toilet contamination due to existing standards once introduced to the growing facilities in reasonable proximity to and routine analytical testing. environment, will eventually die off, but growing areas can reduce produce • Groundwater has the potential to the rate of die-off is dependent upon a contamination. pose a public health risk, despite the number of environmental, regional, and With regard to equipment and regulation of many U.S. public wells other agro-ecological factors. buildings as a route of contamination— being subject to regulation under the • Treatments, such as chemical and • Food contact surfaces are potential Ground Water Regulation. physical treatments and composting, routes of contamination of produce. • There is a significant likelihood that can effectively reduce the levels of • Food contact surfaces such as U.S. surface waters will contain human human pathogens in animal waste. equipment that are designed and pathogens, and surface waters pose the • Among application methods, constructed to be cleanable minimize highest potential for contamination and application of soil amendments in a the potential for contamination of the greatest variability in quality of the manner in which they contact the produce. agricultural water sources. harvestable portion of the crop presents • Pests in buildings used to grow or • Susceptibility to runoff significantly the greatest likelihood of contamination, pack produce can be a source of increases the variability of surface water especially when applied close to contamination of produce. quality. harvest. • Waste material can be a source of • Water that is applied directly to the With regard to animals as a route of contamination, or may become an harvestable portion of the plant is more contamination— attractant for pests and thereby act as a likely to contaminate produce than • Animals can be a source of source of contamination to produce, if water applied by indirect methods that contamination to produce. not properly contained, stored, and are not intended to, or not likely to, • Animal excreta poses a high conveyed. contact produce. likelihood of contamination of produce. The provisions proposed in section V • Proximity of the harvestable portion • Excreta from domesticated animals of this document reflect the above of produce to water is a factor in the poses a greater likelihood of conclusions drawn from our qualitative likelihood of contamination during contamination of produce than does assessment of risk. We seek public indirect application. excreta of wild animals. However, comment on the QAR, conclusions • Timing of water application in domesticated animals can be expected drawn from that assessment, and our produce production before consumption to be more readily controlled (i.e., kept consideration of those conclusions in

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developing the proposed requirements. adulterated under section 402 of the produce or by taking measures to We also request you to submit any data Act. FDA tentatively concludes that provide reasonable assurances that the or factual information that may help the existing programs, such as EPA produce is not adulterated under section agency to conduct, as warranted, a registration of pesticides, and State and 402 of the FD&C Act? Such measures thorough and robust quantitative industry efforts to control the presence might include, for example, preventing assessment of risk associated with of pesticides and mycotoxins in covered produce from entering produce production and harvesting produce, are sufficient to keep these commerce if it may have been practices. hazards under control. In addition, contaminated with radiological hazards under its broader food safety regulatory that may render it injurious to health. B. Focus on Biological Hazards framework, FDA monitors natural toxins As another example, if a covered farm’s Section 419 of the FD&C Act directs (e.g., mycotoxins), pesticides, industrial land was previously used for another us to establish science-based minimum chemicals (such as dioxins; cooking or activity that may have contaminated the standards for the safe production and heating related chemicals, such as soil with chemical hazards such that harvesting of those types of fruit and acrylamide), and other chemical using the land to grow covered produce vegetable raw agricultural commodities contaminants, and radionuclides in may cause introduction of those hazards (RACs) for which we determine that foods. into or onto the covered produce, such standards minimize the risk of For these reasons, we tentatively should proposed § 112.11 require the serious adverse health consequences or conclude that the proposed rule should covered farm to take appropriate death (section 419(a)(1)(A) of the FD&C be limited in scope to biological hazards measures to prevent the introduction of Act). These standards are to be based on and science-based standards necessary the chemical hazards into or onto the known safety risks and to include to minimize the risk of serious adverse produce or by taking measures to procedures, processes, and practices health consequences or death associated provide reasonable assurances that the that we determine to be reasonably with biological hazards. Because of the produce is not adulterated under section necessary to prevent the introduction of proposed rule’s focus on biological 402 of the FD&C Act? Such measures known or reasonably foreseeable hazards, and because of the might include, for example, collecting biological, chemical, and physical effectiveness of cooking and similar and analyzing soil samples for residues hazards into fruit and vegetable RACs processes on the reduction of the of pesticides that are typically used in and to provide reasonable assurances likelihood of contamination of such the production of cotton, if you intend that produce will not be adulterated hazards, as described in the Qualitative to use a former cotton field for produce under section 402 of the FD&C Act Assessment of Risk, we also propose to production. We seek comment on (sections 419(b)(1) and 419(c)(1)(A) of exempt produce that is rarely consumed whether, and to what extent, chemical, the FD&C Act). raw or that receives commercial physical, or radiological hazards should As discussed in the QAR, available processing that adequately reduces the be covered within the scope of this rule. data and information clearly establish presence of microorganisms of public that human pathogens constitute a health significance (see section V.A. of C. Consideration of Differing Risk of biological hazard with the potential to this document). Different Commodities and Practices cause serious adverse health We request comment on this Section 419 of the FD&C Act also consequences or death and result in the approach, and specifically on whether directs us to establish requirements that vast majority of foodborne illness there are practices that are reasonably would provide sufficient flexibility to be known to be associated with produce necessary to prevent the introduction of applicable to various types of entities consumption. By contrast, chemical, known or reasonably foreseeable engaged in the production and physical, and radiological hazards chemical, physical or radiological harvesting of fruit and vegetable RACs, associated with produce rarely pose a hazards into produce or otherwise to including small businesses and entities risk of serious adverse health provide reasonable assurances that that sell directly to consumers, and to be consequences or death for individuals produce is not adulterated under section appropriate to the scale and diversity of that would consume the product (Ref. 402 of the FD&C Act because of the production and harvesting of such 7). Section 419(c)(1)(A) of the FD&C Act chemical, physical, or radiological commodities (section 419(a)(3)(A) of the requires FDA to ‘‘set forth those hazards. For example, proposed FD&C Act). Section 419 further directs procedures, processes, and practices § 112.11 would require covered farms to us to acknowledge differences in risk that the Secretary determines to take appropriate measures to minimize while minimizing, as appropriate, the minimize the risk of serious adverse risks of serious adverse health number of separate standards we apply health consequences or death, including consequences or death from the use of, to separate foods (section 419(c)(1)(D) of procedures, processes, and practices or exposure to, covered produce the FD&C Act). We considered different that the Secretary determines to be attributable to biological hazards that approaches to determine how we might reasonably necessary to prevent the may arise unexpectedly and therefore most appropriately respond to these introduction of known or reasonably not be reflected in a specific standard directives, informed by the information foreseeable biological, chemical, and set forth in proposed subparts C to O of contained in the Qualitative Assessment physical hazards * * * and to provide this rule, or when there are biological of Risk. These primarily included: reasonable assurances that the produce hazards specific to a covered farm’s • Commodity-specific approach— is not adulterated under section 402 [of location or circumstances for which covering only those produce the FD&C Act].’’ The frequency and such measures would be appropriate. commodities or commodity groups that nature of chemical, physical, and Should § 112.11 also apply, for example, might be described as posing a relatively radiological hazards in produce are such in the event of an accident or other higher risk of foodborne illness or that promulgation of a new regulatory unexpected event, such as a likelihood applying different requirements to regime for their control does not, at this of radiological contamination relevant commodity categories based on relative time, appear to be reasonably necessary to a covered farm’s location, to require risk of foodborne illness represented by to prevent their introduction into that the covered farm take appropriate the commodity category (such as higher, produce or to provide reasonable measures to prevent the introduction of moderate and lower risk). A benefit of assurances that produce will not be radiological hazards into or onto the opting to pursue a commodity specific

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approach would be a reduction in the commodities and commodity groups by both reported and assigned to a food costs of the proposed rule. Some risk in our Qualitative Assessment of vehicle, outbreak data may not provide commodities have little or no history of Risk. a complete picture of the commodities links to foodborne illness and, thus, upon which we need to focus to a. Relative Risk Considerations exempting them from coverage could minimize current and future risk of reduce costs to farmers with little or no To fully explore the viability of a illness. The food vehicle responsible for reduction in calculated benefits from commodity-specific approach, we an outbreak is not identified in about the rule. However, because foodborne reviewed the relative risk of different half of all outbreaks. Identifying the illness outbreaks have regularly been commodities using four such data vehicle of an outbreak in which the associated with commodities that have sources: Outbreak data; Pathogen vehicle is contained in a multi- previously not been linked to outbreaks, surveillance data; Commodity ingredient food (e.g., salsa, salads) is this approach carries the risk of failing characteristics; and Market channels. particularly challenging. As our abilities to prevent future outbreaks. Our analysis shows that each data to detect outbreaks and to identify food • Integrated approach—covering all source presents certain gaps that make vehicles responsible for an outbreak produce commodities except those that it challenging to develop a commodity- improve, including refining our pose little or no risk of foodborne illness specific approach that would adequately approach to outbreaks associated with and then applying the most stringent minimize risk of serious adverse health multi-ingredient foods, it is likely that requirements to agricultural practices consequences or death. We explain our previously unrecognized outbreak that pose the greatest likelihood of analysis below and request data and vehicles will be identified. A further contamination of the produce, factual information on how we might complication to use of outbreak data as regardless of the covered produce address these gaps and further develop an indication of commodity risk is that, commodity. A benefit of selecting this and consider a commodity-specific until a food is identified as a vehicle in option is that we would cover all approach. an outbreak, public health officials may commodities except those that pose i. Outbreak Data and Commodity Risk: not be likely to include questions about little or no risk of foodborne illness, an We reviewed FDA’s data on produce- that commodity when investigating an approach that takes into account the related outbreaks and considered outbreak, making the attribution of sporadic and unpredictable nature of categorizing commodities or commodity outbreaks to commodities with no illness outbreaks, while still being groups by risk based on documented outbreak history more difficult. sensitive to risk. association of specific produce In addition, as discussed in the QAR, As discussed below, we explored both commodities with specific outbreaks of our data show that the patterns of approaches thoroughly using human illness (Ref. 2). Using this outbreaks associated with produce information available to us at this time, approach, we could exempt certain commodities change over time. Some and propose to use an integrated commodities or commodity groups that commodities have a continuing and approach. Based on available data, we had never been linked to human repeated pattern of association with have not been able to fully develop a illnesses or were only rarely linked to outbreaks, over multiple years, such as commodity-specific approach that we human illness; this would allow us to tomatoes and leafy greens (Ref. 2). On believe would adequately minimize risk reduce the costs of the rule with little the other hand, occasionally a produce of serious adverse health consequences or no reduction in calculated benefits. commodity is associated with an or death from biological hazards in However, our QAR also leads us to outbreak that had not been previously produce. However, as discussed in tentatively conclude that past patterns linked to foodborne illness. For section IV.C.1.b., we have tentatively of outbreaks by commodity have example, prior to the 2008 Salmonella identified an approach based on limitations which make it challenging to Saintpaul outbreak (Ref. 37), jalapeno outbreak data, and we further explore use as a key determining factor in and serrano peppers had not been that option in that section. We welcome establishing the scope of this proposed identified as vehicles in a foodborne comment on this approach and ask that rule or how its provisions apply. We illness outbreak. Papayas had also not you provide data and factual briefly discuss the reasons here (please been associated with outbreaks, prior to information that would help us to refer to the QAR for more information). an outbreak that occurred in 2011. further consider developing this or Our QAR concluded that some Therefore, a regulatory approach that another appropriate commodity-specific produce types are repeatedly associated relied on a static list of commodities approach. with reported foodborne illness, prepared solely from a history of whereas other produce types are outbreaks would not be able to prevent 1. Commodity-Specific Approaches intermittently associated with reported future outbreaks in commodities not As noted above, there are multiple foodborne illness. Still other produce previously associated with an outbreak. possible approaches that we could take commodities have not been associated If we adopted an approach that with respect to produce. One of them is with reported foodborne illness. As exempted commodities without a what we refer to as a ‘‘commodity- such, five commodity groups (leafy history of outbreaks, we would likely specific approach’’ in which this rule greens, tomatoes, herbs, melons, and need to add commodities as future would apply only to those produce sprouts) together account for 77 percent outbreaks occur. For example, we could commodities or commodity groups that of all produce-related outbreaks from adopt a ‘‘moving window’’ approach pose a relatively higher risk of 1996–2010 (Ref. 3). These commodity that would consider only outbreaks over foodborne illness. (We could also groups also account for 54 percent of a given time period. For example, we simply apply different or less stringent produce-related illnesses and 56 percent could consider only the outbreaks over requirements to the relatively lower-risk of produce-related hospitalizations. the most recent five years at any given commodities.) In theory, commodities Sprouts account for a quarter of the time. Using such an approach, produce might also be grouped into higher, produce related outbreaks (26%), 15 commodities or commodity groups moderate, or lower levels of risk with percent of the illnesses, 9 percent of the might move onto and off of the higher different levels of stringency applied to hospitalizations, and one death. risk list over time based on changes in each. As discussed in section IV.A. As discussed in the QAR, because outbreak data. The advantage of such an above, we attempted to categorize only a small percentage of outbreaks are approach could potentially be to

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recognize and reward efforts by industry because we do not believe that the past categorizing and regulating commodities segments that implement changes in history of outbreaks can be fully based on outbreak history or practices contributing to reduced predictive of future outbreaks. surveillance data, we also considered outbreaks associated with their Historically, outbreaks are sometimes using characteristics of produce commodities, and provide an incentive linked to commodities that had no commodities themselves, such as for other industry segments to enhance previous associated illnesses. If we were growth habit. In other words, if, for the safety of their practices. However, to develop a commodity-specific list of example, the risk of illnesses associated the adoption of such practices by an covered produce, we could add with tree fruit, were consistently lower industry segment does not change the commodities to the list as more data than the risk of illness from risk posed by the commodity in the became available. We request comment commodities grown in the soil, such a absence of such practices, such as when on whether this option would distinction might provide the basis of an practices are not universally adopted or adequately minimize the risk of serious exemption. However, as demonstrated they are discontinued. In the absence of adverse health consequences or death in the QAR, we found that it would be those practices, illness outbreaks may and whether it would sufficiently move extremely difficult to make conclusions resume. For example, sprout associated toward a prevention-based food safety across commodity groups that are outbreaks appeared to decline after system. We request comment on this consistent with outbreak and release of our Sprout Guides in 1999 determination and on the specific surveillance data, in light of the and, for three years (2005–2007), there approaches we have outlined here. We diversity of commodities, practices, and were no reported outbreaks associated are particularly interested in the conditions across operations. with sprouts, presumably because of marginal effects of adopting this Attempts to categorize produce by improved practices during the approach: If we exempted commodities commodity characteristics is production of sprouts (Ref. 3). However, based on a history of outbreaks, what confounded by the outbreak data, which outbreaks have recurred since that time would the likely reductions in the costs show no consistent pattern that can be period, possibly because practices have of the rule be, and what would the matched to commodity characteristics regressed to some extent or possibly likely increase in human illnesses be such as growth habit. As discussed in because of the entry of new sprout from this approach. the QAR, the characteristics of growers who were not familiar with the ii. Pathogen Surveillance Data and approximately 20 produce commodities voluntary recommendations in the Commodity Risk: As an alternative to associated with outbreaks are diverse Sprout Guides and had not adopted categorizing and regulating commodities and include: them. In late 2008, there was one based on outbreak history, we • Crops generally grown without soil, sprout-associated Salmonella outbreak; considered using data on levels and such as sprouts; in 2009, a Salmonella outbreak frequency of pathogen detection, such • Crops where the harvestable portion associated with sprouts resulted in more as by surveillance sampling assignments grows in the ground, such as green than 200 illnesses; and in 2010, there in specific produce commodities. As onions; were 3 outbreaks associated with demonstrated in the QAR, this approach • Row crops where the harvestable sprouts (Ref. 3). Further, as discussed in would also present a number of portion grows on or near the ground, the QAR, some commodities (e.g., leafy challenges. Of most importance, our such as lettuce, spinach, basil, parsley greens) are consistently associated with contamination data are limited in that and cantaloupe; outbreaks while others (e.g., grapes, most sampling programs have focused • Crops where the harvestable portion jalapeno peppers) are only rarely on produce commodities that have an grows above the ground, such as associated with outbreaks. With a existing history of known outbreaks, tomatoes and chili peppers, raspberries moving window approach those providing little additional information and blueberries; and • commodities that only intermittently are about the risk presented by commodities Crops where the harvestable portion associated with outbreaks may cycle on that do not have such a history. Given grows on trees, high above the ground, and off the higher risk list, even though the potential for system failure and such as mangoes and almonds. their risk may not have actually sporadic contamination, it is probable Moreover, as discussed in the QAR, changed. For these reasons, we have that testing of other produce even within what may be a reasonable tentatively concluded that a ‘‘moving commodities may eventually lead to set of commodities to group together, window’’ approach for determining risk positive identification of contamination. physical characteristics of the produce based on outbreak history is not viable. For example, when we added that could alter the potential for Grouping commodities based on cucumbers to our surveillance sampling contamination do not always appear to outbreak history also has challenges. program in 2009, we found a significant do so. For example, within the melon Within a commodity group, number of positive samples for group, cantaloupe has a netted rind, contamination may have been Salmonella spp. although, in previous whereas honeydew has a smooth rind, associated with relatively few types of years, cucumbers had not been seemingly making it less likely to harbor produce, such as cantaloupe and identified as the vehicle of a foodborne pathogens. However, both have been honeydew melons within the melon outbreak in FDA’s database. We also associated with outbreaks (Ref. 3). group, which includes multiple species, found pathogens in and on produce In addition, multiple characteristics or more broadly, such as roma, red commodities such as broccoli, culantro, would have to be considered to create round, plum, and grape tomatoes within rapini, and radicchio that have not been commodity groupings, making such an the tomato group, which consists of currently identified in outbreaks (Ref. approach very complicated. For multiple varieties within a single 3). For this reason, we do not believe example, while growth characteristics, species (Ref. 3). that pathogen surveillance data alone such as distance between the edible Having considered that making can provide sufficient information for a portion of the plant and the ground, exemptions solely based on outbreak risk-based exemption from the proposed may make a commodity less likely to data could significantly reduce the costs rule’s provisions. We request comment become contaminated through certain of the proposed rule with little or no on this determination. routes, (e.g., tree fruit may be less reduction in calculated benefits, we iii. Commodity Characteristics and vulnerable to contamination from have not selected this alternative, Commodity Risk: As an alternative to grazing animals), distance from the

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ground does not necessarily provide an other commercial channels as compared outbreak data may not provide a increased level of protection against to produce in direct market channels if complete picture of the commodities other sources of contamination (e.g., there are greater numbers of touch upon which we need to focus to direct contact with a crop protection points and handlers in these channels minimize current and future risk of spray if the spray mix were made using than there are in direct market channels. illness. contaminated water). Furthermore, once We seek comment on this tentative Another possible commodity-specific the produce commodity is removed conclusion. approach that attempts to account for from the growing area, it may lose any Section 419(f) of the FD&C Act the drawbacks of the above approach safety advantage it had in the field provides a qualified exemption from would be to cover all of the based on growth characteristics if it is this proposed rule for many farms commodities that have been identified exposed to routes of contamination such selling directly to consumers or other as associated with an outbreak at any as poor worker hygiene practices, ‘‘qualified end users,’’ and as a result, time. Produce commodities that have contaminated water, or insanitary food many farms that primarily use direct not been identified as associated with contact surfaces. As another example, market channels will not be subject to an outbreak could then either not be mangoes are an example of a produce the requirements of this proposed rule subject to the proposed rule, or be commodity that may be thought to (with qualifications provided by the subject to the proposed rule but with present relatively low risk of foodborne statute). Because the statutory qualified less stringent requirements. This option illness, but for which poor water quality exemption addresses market channels as would address more than the percent of management during insect a possible risk factor, and because we known outbreaks addressed by the disinfestation hot water treatment and identified no data that would allow us above approach in that it would address cooling as part of harvest, packing, and to otherwise use market channels as a all known outbreaks. This approach holding resulted in an outbreak (Ref. factor in covering and regulating would also significantly reduce the 38). Some physical characteristics of produce under this proposed rule, we costs of the proposed rule by exempting produce commodities (e.g., netted rind tentatively conclude that we should not produce categories that have never been of cantaloupe or large, rough surface otherwise use market channels as a associated with human illness. As area of some leafy greens) may increase basis of risk categorization in this discussed above, however, outbreaks the likelihood of contaminants being proposed rule. We seek comment on have been associated with commodities trapped and surviving long enough to this tentative conclusion. without an illness history. Although we would expect to use additional data to cause illness, but as noted earlier, these b. Considering an Appropriate update any list we might develop of characteristics do not necessarily Commodity-Specific Approach determine whether contamination commodities subject to the provisions of occurs or persists. In the previous section, IV.C.1.a, we the rule, we would expect that this For the reasons described here, we discuss four different relative risk approach would not minimize the risk have tentatively determined that such considerations that might be used to of occurrence of some number of an approach cannot serve as the sole develop an appropriate commodity- additional outbreaks and illnesses. basis for a risk-based exemption from specific approach. Each has a set of We have discussed limitations with the proposed rule. We request comment challenges, as discussed above. Of the each of the above methods of creating a on this determination and on whether four, outbreak data provide the most risk-based exemption from the rule. We there are known produce characteristics direct representation of public health could also combine two or more of the that could serve as a reliable and burden, even considering the confines approaches used above to create a more practicable indicator of contamination associated with these data. In this holistic picture of risk. For example, we and illness risk. We seek comment on section we further explore how outbreak might combine a history of outbreak this issue and data to inform commodity data might be used to identify data with the growing characteristics of categorization. commodity groups or specific a commodity or class of commodity. iv. Market Channel and Risk: We also commodities to cover in this proposed Such an approach could potentially considered whether different market rule. exempt additional commodities that channels might have an impact on the One possible commodity-specific pose minimal or no risk (in addition to likelihood of contamination of produce approach would be to cover those those we already considered in the and therefore whether use of certain commodity groups that have been proposed approach: Those specified as market channels should be a factor in associated with outbreaks. Commodity rarely consumed raw, and those that are covering or regulating produce in this groups ‘‘associated with outbreaks’’ receive commercial processing that proposed rule. In particular, we could be identified as, for example, adequately reduces the presence of considered whether there is a difference commodity groups associated with one microorganisms of public health in the likelihood of contamination of or more outbreaks during a set period of significance). If there were individual produce that is sold directly to the time. The remaining commodity groups commodities or classes of commodities consumer or end user (‘‘direct market could then either not be subject to the that have not been linked to human channels’’) as compared to that of proposed rule, or be subject to the illness and we had reason to believe that produce that is sold into other proposed rule but with less stringent they were unlikely to be linked to commercial channels. We are not aware requirements. A commodity-specific human illness in the future, we would of any data that would enable us to approach that covers the commodity consider exempting these commodities compare the likelihood of groups associated with outbreaks would or classes of commodities from some or contamination in these two situations. target the commodity groups that all provisions of the rule. This would We tentatively conclude that produce in present the greatest public health reduce the cost of the rule without both direct market channels and other burden. However, as discussed above in significantly reducing the calculated commercial channels are subject to the section IV.C.1.a., there are various benefits of the rule. However, we have same routes of contamination, although drawbacks with using outbreak data in not been able to fully develop an the number of opportunities for this way. For example, because only a approach that might combine a history contamination during packing and small percentage of outbreaks are both of outbreak data with the growing holding may be greater for produce in reported and assigned to a food vehicle, characteristics of a commodity or class

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of commodities to create risk-based can be expected not to transfer direct market channels, or to other exemptions from the rule and, thus, contamination onto the interior, edible factors? minimize the risk of serious adverse portion of the commodity. Should such D Should market channels be used as health consequences or death. We seek commodities be covered by the rule? Is a basis for risk categorization? If so, comment on this issue. Is there coverage of these commodities how? Is there a need to consider market information in the QAR that could be unnecessary? Should they be covered channels in risk categorization, used to develop such a system of risk- but subject to a less stringent set of considering that the statutory qualified based exemptions? Are there requirements? exemption already addresses market commodity characteristics or growth Æ Certain commodities are ranked in channels as a possible risk factor? conditions that could be used as a basis the QAR as presenting a relatively lower D Are other data or information to develop such a system? Do the likelihood of exposure, in part because available that would otherwise be useful proposed provisions for variances (see such commodities have fewer potential in considering a commodity-specific section V.P. below) adequately address routes of contamination and/or lower approach? this issue? potential for contamination. In addition, 2. Integrated Approach, as Proposed We ask for comment on all of the some commodities are not known to As discussed in section IV.A. above, above approaches, and we especially have been associated with outbreaks. our QAR indicates that some produce ask for comment on the likely marginal Some commodities (for example, pears, types are repeatedly associated with effects of the different risk-based grapefruit, oranges, and lemons) meet reported foodborne illness whereas exemptions. If we adopted one of the both of these criteria, considering the other produce types are intermittently approaches above, what would the rankings and outbreak data used in the likely reductions in the costs of the associated with foodborne illness. Still QAR. Should commodities that meet other produce commodities have not proposed rule be, and what would the both of these criteria be covered by the likely increases in human illnesses be been associated with reported foodborne rule? Is coverage of these commodities illness. Likely factors contributing to the (using our proposed rule as a baseline). unnecessary? Should they be covered We also ask for comment on whether likelihood of contamination, exposure, but subject to a less stringent set of and illness include: Agricultural any of the above approaches would be requirements? How should the rule sufficiently protective of the public practices used during growing, address the changing nature of outbreak harvesting, and postharvest; physical health. data over time? Æ characteristics of the crop; consumer c. Need for additional data and How should the agency account for and retail handling practices (such as information uncovered commodities in considering cooking and peeling); and rates of We seek comment on our analysis and a commodity-specific approach that consumption. However, use of poor considerations related to considering an relies on outbreak data? agricultural practices could lead to appropriate commodity-specific D Are there pathogen surveillance contamination and illness, even where approach that would adequately data from sampling programs focusing the potential for contamination is minimize risk of serious adverse health on produce commodities that have no relatively low. consequences or death from biological history of known outbreaks that would Therefore, we tentatively conclude hazards associated with produce. We be useful in considering a commodity- that an integrated approach that focuses also request comment on whether and specific approach? on the likelihood of contamination of how different relative risk D Can commodity characteristics be produce posed by the agricultural considerations, including outbreak data, used as a basis to consider a practices applied to the crop, while pathogen surveillance data, commodity commodity-specific approach? While exempting the lowest-risk produce, characteristics and/or market channels, the outbreak data show no consistent would provide the most appropriate could be used to develop a commodity- pattern that can be matched to balance between public health specific approach, and data and factual commodity characteristics such as protection, flexibility, and appropriate information that would address the growth habit, our QAR shows that management of different levels of risk. drawbacks that are discussed in this produce commodities that are ranked as We tentatively conclude that controls section IV.C. that may be accounted for higher risk of illness and those ranked should be tailored, taking into account in such an approach. Specifically, as lower risk of illness do share some of the analysis done by the farm in certain D Are there specific commodities or the same characteristics. A further areas, to the potential routes of categories of commodities that should refinement of our assessment might be contamination that each commodity be excluded from the scope of the rule, helpful in developing a commodity- presents based on the agricultural based on data related to their relative specific approach based on commodity practices employed, and the risk considerations? (Note that under characteristics. Considering the characteristics of the commodity and our proposed integrated approach, we qualitative nature of our assessment, are the environmental conditions under propose to exempt certain commodities, there quantitative data sets available which it is grown. including a specified list of produce that that would enable a further refinement Based on our QAR, we are able to is rarely consumed raw, and produce of our assessment? identify certain conditions under which that receives commercial processing that D Are produce in both direct market produce commodities constitute very adequately reduces the presence of channels and other commercial low to no risk with respect to biological microorganisms of public health channels subject to the same routes of hazards. We tentatively conclude that, significance; see section V.A.2.a. of this contamination? Is the number of under these conditions, science-based rule.) opportunities for contamination during minimum standards to minimize the Æ For example, the QAR ranked packing and holding greater for produce risk of serious adverse health certain produce commodities, such as in other commercial channels as consequences or death from biological bananas and coconuts, as lower risk for compared to produce in direct market hazards in produce are not warranted. illness, in part because such channels? If yes, is this due to greater As described in the QAR, such commodities are peeled or shelled numbers of touch points and handlers conditions include produce that before consumption in a manner that in these channels than there are in receives commercial processing that

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adequately reduces the presence of standards (proposed subpart M) for this We tentatively conclude that the microorganisms of public health produce commodity is warranted. appropriate way to minimize the risk of significance (proposed § 112.2(b)); and The requirements of the proposed serious adverse health consequences or produce commodities that are rarely regulation would be based on identified death is to require all covered farms to consumed raw (proposed § 112.2(a)(1)). routes of contamination and the comply with the standards in this In each of these cases the produce can associated practices that affect the proposed rule with regard to all but the be expected to receive commercial likelihood that produce becomes lowest risk produce. Identifying the processing or other treatments that contaminated: Agricultural practices higher-risk agricultural practices and significantly minimize the risk of that are more likely to contaminate setting standards in which the serious adverse health consequences or produce would require more stringent stringency of the requirement tracks the death from biological hazards associated measures to ensure that the likelihood risk of the chosen practices is with such produce. of contamination is sufficiently appropriate from a public health risk In addition, as discussed in section minimized. For example, as discussed mitigation standpoint and would also V.A. of this document, FDA proposes in in section V.E. of this document, we are provide an incentive for farmers to § 112.4 to apply this regulation only to proposing the most stringent standards move to lower-risk practices where such businesses with an average annual for water that is used in direct contact options are available. We also expect monetary value of food sold during the with the harvestable portion of covered that our proposed approach is more previous three-year period of more than produce during or after harvest workable for row crop farmers who may $25,000 on a rolling basis, based on a activities (when there is little further grow multiple produce commodities tentative conclusion that businesses opportunity for pathogen die off) and in than it would be if we were to assign with $25,000 or less in sales do not certain other uses that present different requirements to specific contribute significantly to the produce significant safety risk for the safety of commodities based on the risk of market and, therefore, to the volume of the produce (such as irrigation of foodborne illness associated with those production that could become sprouts); less stringent standards for commodities. In these types of contaminated. Accordingly, imposing water that directly contacts the operations, many agricultural practices the proposed requirements on these harvestable portion of covered produce and agricultural inputs (such as water businesses would have little measurable (other than sprouts) during growing sources and distribution systems, soil public health impact. In addition to activities (when the opportunity for amendments and their application these exclusions proposed by FDA, pathogen die off is greater); and no methods) tend to be farm-specific and, section 419(f) of the FD&C Act provides requirements when water is used during thus, relatively consistent across a qualified exemption for certain farms, growing, but does not contact the produce commodities on a given farm. which FDA proposes to implement in harvestable portion of covered produce Requiring different measures from row proposed §§ 112.5 and 112.6, and (other than sprouts). Similarly, we are to row based on the produce commodity subpart R, as discussed in sections V.A. proposing to prohibit the use on covered in that row would likely pose a and V.R. of this document. produce of biological soil amendments considerable burden on such farms. For produce commodities that would that present the greatest likelihood of Setting standards that enable such farms be covered within the scope of this rule pathogen contamination, i.e., untreated to apply consistent measures to multiple (i.e., ‘‘covered produce’’ as defined in human waste (Ref. 39). Untreated crops is consistent with the statutory proposed § 112.3), we are proposing to manure or other untreated biological provision in section 418(c)(1)(D) of the establish science-based minimum soil amendments of animal origin, FD&C Act that directs the agency to standards to minimize the risk of which are less likely to be contaminated ‘‘acknowledge differences in risk and serious adverse health consequences or with human pathogens than human minimize, as appropriate, the number of death. Given our current understanding waste, but are relatively likely to be separate standards that apply to separate of existing microbiological hazards and contaminated (Ref. 35. Ref. 36. Ref. 37), foods.’’ current data limitations, as described in would be allowed, subject to stringent our QAR, we have determined that a requirements; manure or other D. Framework of the Rule regulatory approach that addresses the biological soil amendments of animal potential likelihood of contamination origin that have been properly In developing a framework for this posed by procedures, processes, and composted to reduce the level of proposed rule we considered various practices employed in the growing, pathogens contained therein would be models used in proposed and final FDA harvesting, packing, and holding of subject to less stringent requirements; regulations, including those applied in: produce commodities will be more and certain chemically or physically (1) The existing Current Good effective and appropriate than an treated biological soil amendments of Manufacturing Practice in approach based on the individual animal origin that receive more robust Manufacturing, Packing or Holding commodities’ physical characteristics, treatments to eliminate pathogens Human Food regulation (current 21 CFR known record of contamination, or would be subject to the least stringent part 110; ‘‘Food CGMP regulation’’); (2) known outbreak history. The only requirements. the Production, Storage, and commodity-specific requirements In addition, we are proposing to Transportation of Shell Eggs regulation proposed in this rule are those include other measures that would be (21 CFR part 118; ‘‘Shell Egg designated for sprouts, which have broadly applicable (e.g., personnel Regulation’’); (3) the Hazard Analysis unique growing procedures (i.e., warm, qualifications and training requirements and Critical Control Point (HACCP) moist nutrient-rich environment for an in proposed subpart C, health and Systems (‘‘juice HACCP’’) regulation (21 extended period of time that supports hygiene requirements in proposed CFR part 120); and (4) the Fish and pathogen growth in addition to subpart D; requirements for equipment, Fishery Products (‘‘seafood HACCP’’) sprouting) and, therefore, present a tools, buildings, and sanitation in regulation (21 CFR part 123). None of unique risk profile (Ref. 16.Ref. 2). For proposed subpart L) and the proposed these regulations applies to fruits and this reason, and as discussed in section standards for these are consistent for all vegetables at the point at which we V.M. of this document, we tentatively covered growing, harvesting, packing, propose to regulate such food by this conclude that a specific set of safety and holding operations. regulation (during growing, harvesting,

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packing, and holding on farms), but as critical control points (CCPs) where the Given these considerations, and the models they are instructive. controls must be applied and critical need to tailor the proposed Generally, the Food CGMP Regulation limits, which are the set points for the requirements to specific on-farm routes sets out mandatory, broad, generally- process that must be met to ensure of contamination (as discussed in applicable practices and conditions that product safety. section IV.C of this document), we are required to be met, and the criteria The Food CGMP Regulation and the propose an integrated approach that and definitions in that part are Shell Egg Regulation do not use the draws on our past experiences in the applicable in determining whether the structure applied in the other regulations discussed above. In some food is adulterated (1) within the regulations identified here to ensure cases, we propose standards that are meaning of section 402(a)(3) of the act, that the conditions and practices are very similar to those contained in the in that the food has been manufactured keeping hazards in check as anticipated Food CGMP Regulation, especially under such conditions that it is unfit for (through hazard analysis, establishment where the routes of contamination are food, or (2) within the meaning of of critical control points, monitoring, well-understood and appropriate section 402(a)(4) of the act, in that the corrective actions, verification, and measures are well-established and food has been prepared, packed, or held recordkeeping in all applicable generally applicable across covered under insanitary conditions whereby it contexts). The Food CGMP Regulation produce commodities (e.g., personnel may have become contaminated with preceded the HACCP regulations and is qualifications, training, health, and filth, or whereby it may have been generally thought of as a pre-requisite or rendered injurious to health. The hygiene; harvesting, packing, and foundation to those regulations. That is, holding activities; equipment, tools, criteria and definitions in that part are it is generally recognized that HACCP- also applicable in determining whether buildings, and sanitation). We rely on type regulations must build on the this approach where possible, in part, a food violates section 361 of the Public foundation of a good manufacturing Health Service Act. In some instances because we tentatively conclude that practice (GMP)-type regulation in order compliance would be more suitable where the appropriate measures are to further reduce the risk of illness or universal and well recognized, the with this regulatory framework (given injury to consumers associated with the diversity of the industry with cGMP requirements are prescriptive contaminated produce (Ref. 40 Ref. 41). (e.g., the requirement to remove respect to size, agricultural practices, In developing the framework for this unsecured jewelry at § 110.10(a)(4), the and knowledge of food safety) than proposed rule, we considered the requirement that each freezer and cold would be the case with a more complex storage compartment be fitted with a following: (1) The produce farming framework such as one that also temperature indicating thermometer, community is very diverse, including required an individual written plan. very small and large farms, some with temperature measuring device or In other cases, we have proposed temperature recording device at significant expertise in the area of food safety and others with minimal specific numerical standards against § 110.40(e)). However, more commonly, which the effectiveness of a farm’s because of the diversity of operations knowledge in the area, some located in the U.S. and some abroad; (2) there is a measures would be compared and subject to the regulation and the desire actions taken to bring the operation into to provide flexibility for operators to put broad range of crops and agricultural practices employed by the produce conformance with the standards, as in place measures that are best suited to necessary (e.g., proposed standards for the specifics of their operation, the farming community, such that a measure for addressing an on-farm route agricultural water in subpart E; cGMP rule sets out more general biological soil amendments of animal requirements (e.g., the requirement that of contamination for one produce commodity in one region may not be origin in subpart F; sprout persons working in direct contact with environmental testing and spent sprout food conform to hygienic practices to practical or effective for another on-farm route of contamination, produce irrigation water testing in subpart M). the extent necessary to protect against We rely on such a numerical standards contamination of the food at § 110.10(b), commodity or region; (3) this proposed approach where the effectiveness of the requirement that food that can rule is the first effort by FDA to regulate individual measures (e.g., protection of support the rapid growth of undesirable the produce farming community—the agricultural water sources from microorganisms be held in a manner produce farming community does not contamination, establishment of that prevents the food from becoming have the history of regulatory adulterated at § 110.80(b)(3)). Many interaction with FDA and the same application intervals for certain soil provisions of the Shell Egg Regulation experience with food safety regulations amendments, and chemical disinfection also take a similar approach to the Food as does the food manufacturing treatment of seeds before sprouting) is CGMP Regulation. industry; (4) the adequacy of some not complete or fully known and/or The Juice HACCP and Seafood measures to control specific known or because much of what affects the on- HACCP Regulations set out mandatory reasonably foreseeable hazards affecting farm route of contamination is outside frameworks through which entities produce is well established, while the control of the farm (e.g., the quality subject to those regulations assess the others are poorly studied, suggesting of a particular surface water source). In hazards that are reasonably likely to that future research may identify some of these cases (e.g., composting of occur in their products and processes alternative measures that may be more biological soil amendments of animal and design tailored controls to prevent effective and/or efficient; and (5) some origin in proposed § 112.54) we have or eliminate them or reduce them to an on-farm routes of contamination occur provided measures that are well acceptable level. These regulations in a relatively controlled environment established to meet the numerical require the development of a plan, (e.g., a fully or partially enclosed standard under a wide range of based on the assessment of hazards, building), while others occur in an conditions, while also recognizing that which includes monitoring procedures, outdoor environment that may be other measures, if properly validated, corrective action procedures, beyond the control of the farm (e.g., an may also be suitable (see proposed verification procedures, and open field), affecting the ability of the § 112.12, discussed in section V.B. of recordkeeping procedures. The plan farm to take measures that minimize the this document). Our proposed use of also includes the identification of the likelihood of contamination. numerical standards is similar to the

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requirement for egg testing in the Shell enterohemorrhagic E. coli (EHEC), and problems and, thus, enable a farm to Egg Regulation. irrigation water (with and without find and correct the source of problems. In still other cases, we have proposed proposed measures in place), and Records are also useful for investigators a standard that requires the farm to concluded that a number of variables during inspections to determine inspect or monitor an on-farm route of may influence the predicted EHEC compliance with requirements (e.g., by contamination and take appropriate illnesses associated with fresh-cut FDA investigators to determine measures if conditions warrant. We rely lettuce, as defined by the model compliance with requirements that on such a monitoring approach where scenarios that included contamination would be established by this rule, or by the diversity of conditions that can be from irrigation water and other a third party auditor that a farm or expected relative to an on-farm route of environmental sources on the farm, and retailer may voluntarily engage under a contamination is very high and it would changes in the contamination during the business arrangement between the farm be impractical and unduly restrictive to product life cycle from farm to and the retailer). We propose to require set out a standard that specifies the consumption. The quantitative risk records in instances where they are appropriate measures for each possible assessment document is currently being important to facilitate verification and circumstance (e.g., requirements for peer reviewed and changes can be compliance with standards and this monitoring for animal intrusion in reasonably anticipated based on the cannot be effectively done by means proposed § 112.83, requirement for peer review. The peer review plan is other than a review of records; where inspection of agricultural water system available online at http://www.fda.gov/ identification of a pattern of problems is in proposed § 112.42). In addition, we ScienceResearch/SpecialTopics/ important to minimizing the likelihood propose this approach in instances PeerReviewofScientific of contamination; and where where further research is needed to fully InformationandAssessments/ maintenance of detailed information is understand the effectiveness of ucm079120.htm. We will consider peer needed by the operator in order to measures to mitigate the risk of serious reviewers’ and public comments in minimize the risk of contamination and adverse health consequences or death. finalizing the quantitative risk demonstrate their compliance. Our proposed use of inspection and assessment and this proposed rule. monitoring followed by appropriate This rulemaking is not intended to F. Farm-Specific Food Safety Plans corrective action is similar to the address ‘‘hazards that may be Each farm has a unique combination requirement to monitor for rodent intentionally introduced, including by of size, climate, crops grown, current activity and take corrective action on acts of terrorism.’’ (§ 418(b)(2) of the and previous use of its own land and egg farms in the Shell Egg Regulation FD&C Act). FDA plans to implement nearby land, sources of agricultural (§ 118.4). section 103 of FSMA regarding such water, growing, harvesting, packing, and Finally, in still other cases, we hazards in a separate rulemaking in the holding practices, animal grazing, propose a standard that requires the future. FDA tentatively concludes that potential for domestic and wild animals farm to develop a written plan, intentional hazards likely will require to enter growing or packing areas, and committing itself to specific measures different kinds of controls and would be sewage or septic system. Relevant (e.g., sprout environmental testing and best addressed in a separate rulemaking. documents on produce safety, such as spent sprout irrigation water testing). However, we request comment on our GAPs Guide (Ref. 10), industry We propose the use of written plans whether we should include standards CSGs for melons, tomatoes, leafy greens, where the details of the measures to be related to preventing economically and green onions (Ref. 43. Ref. 44. Ref. taken are more than can be reasonably motivated intentional adulteration of 45. Ref. 46), the CA and AZ LGMA (Ref. expected to be retained in memory, produce in this rule. Is economically 31. Ref. 32), the AFDO Model Code of especially where the details may change motivated adulteration of produce Produce Safety (Ref. 20), the Codex over time and a historical record of the reasonably likely to occur and, if so, by Guide (Ref. 47), and Industry evolution of the measures is important what mechanisms may potential Harmonized GAPs (Ref. 48. Ref. 49) for the operator to assess whether hazards be intentionally introduced in recommend that a farm tailor its food further changes to the measures are produce for economic reasons? If such safety practices to the practices and needed (e.g., changes or rotation in the adulteration is reasonably likely to conditions at its individual operation. In sampling sites for sprout environmental occur, what standards should FDA addition, many of these documents testing). Such plans are also important consider for preventing such explicitly recommend that a farm for the efficient enforcement of the adulteration? conduct an assessment of its growing standard as they serve as a clear environment and may specify when commitment on the part of the operator E. Records assessments should be done (e.g., before of the farm to a particular course of We are proposing to require that farms planting, during production, and action, against which their actual keep records as a component of the immediately prior to harvest) to identify performance can be judged by the above described standards, under potential food safety hazards in light of regulator. Our proposed use of written certain, limited circumstances. In its particular commodities, practices plans in these specific instances is determining those circumstances in and conditions (Ref. 43. Ref. 44. Ref. 45. similar to the requirement for a written which records are necessary, we Ref. 46. Ref. 40. Ref. 47). Salmonella Enteritidis prevention plan considered the statutory direction in Several of these documents further on egg farms in the Shell Egg Regulation section 419(c)(1)(C) of the FD&C Act to recommend that a farm use the findings (§ 118.4). comply with the Paperwork Reduction of its assessment to help establish a plan We performed a quantitative risk Act (44 U.S.C. 3501 et seq.) ‘‘with to control potential hazards (Ref. 43. assessment to estimate the predicted special attention to minimizing’’ the Ref. 46. Ref. 48. Ref. 45. Ref. 49. Ref. 28. effectiveness of some of the provisions recordkeeping burden on the business Ref. 18)(Ref. 50. Ref. 51). For example, of the proposed regulation with respect and collection of information as defined the introduction to the AFDO Model to one example commodity and one in that act. Code notes that a food safety plan example pathogen (Ref. 42). This Records are useful for keeping track of should be commensurate with the size quantitative risk assessment evaluated detailed information over a period of and complexity of an operation and the the combination of fresh-cut lettuce, time. Records can identify patterns of inherent risks of the commodities

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grown, along with site specific practices a prominent place in many public and fruits and vegetables) pays particular and conditions. The purpose of a food private produce guidance documents, as attention to minimizing microbial safety plan is to establish measures discussed above. hazards. It concentrates on microbial designed to prevent the introduction of The importance of tailoring what you hazards and addresses physical and known or reasonably foreseeable food do at an individual operation to your chemical hazards only in so far as they safety hazards into or onto produce in commodities, practices and conditions relate to good agricultural and light of the crops, practices, and is commonly accepted, and an manufacturing practices. The Codex conditions at the physical location of operational assessment and food safety Code recommends measures applicable the farm and would include, for plan could be valuable tools for farms to to all stages of the production of fresh example, measures applicable to an select and implement those fruits and vegetables, from primary individual farm for agricultural water, recommendations which are appropriate production to packing, with a particular animal grazing, and any specific hazards for their circumstances. While we are emphasis on those intended to be identified in the recommended not proposing to require farms to consumed raw (Section 2.1 of the Codex operational assessment. The FDA draft conduct an operational assessment or Code). In proposed § 112.2(a)(1), we CSGs recommend developing and develop a food safety plan, we do propose to exempt a specified list of maintaining written food safety plans recommend that farms do so, because produce that is rarely consumed raw and SOPs for areas such as handling and this could help farms be more effective from the scope of this rule. Similarly, storage practices, field, facility, and in protecting the safety of their produce. for those commodities not cooked before vehicle cleaning and sanitation, and Further, we request comment on consumption, the Codex Code employee training programs. A number whether we should require that some or recommends a set of broadly applicable of comments to the 2010 FR notice all covered farms perform operational minimum standards, with risk-based maintained that the most effective assessments and/or develop a food adjustments. approach to produce safety would be safety plan, and if only some, what With respect to agricultural water, the one that incorporates food safety plans criteria should be used to separate those Codex Code recommends the developed at the operational level. to whom the requirement would apply assessment of agricultural water for from those to whom it would not. Conversely, another group of comments suitability for use; special attention to questioned the need for some industry G. Foreign Farms irrigation water that is directly applied segments, such as small farms or The proposed rule would apply to to edible portion, especially close to growers of ‘‘low risk’’ commodities to foreign farms that meet the criteria to be harvest; and use of clean water for develop or implement food safety plans. covered farms and that grow, harvest, initial stages followed by potable water The above-mentioned documents pack, or hold covered produce for for later stages during and after harvest, provide guidance or recommendations import into the United States. This is including cooling (Section 3.2.1.1 of the for operators to consider and, as such, protective of public health, as foreign Codex Code). Many of the proposed do not represent requirements that must farms have been implicated in provisions described in section V.E. of be met. We recognize that requiring foodborne illness outbreaks associated this document are consistent with these covered farms to conduct a hazard with contaminated produce consumed recommendations. analysis and develop a food safety plan in the United States (Ref. 3). This is also As another example, the Codex Code at the level required in our juice and consistent with the requirements of recommends that personnel follow seafood HACCP regulations, or section 419 of the FD&C Act, which health and hygiene requirements and prescribed by section 418 of FSMA for clearly contemplates that the rule issued that toilet and hand washing and drying food manufacturing/processing under that authority will apply to facilities be provided during and after facilities, may not be feasible. We also foreign farms. This is apparent in harvest, which are reflected in the recognize that, at this time, only limited sections 419(c)(1)(F) and (c)(2), which proposed provisions described in tools are available to help with the provide for a variance process in which section V.D. of this document. In development of on-farm food safety states or foreign countries from which addition, the proposed provisions plans. food is imported into the US may described in section V.L. of this Also as noted above, this proposed request variances from FDA. Foreign document and the Codex Code both rule is the first effort by FDA to regulate countries would not be eligible to recognize the importance of proper the produce farming community. We request variances from this rule if design, construction, maintenance and have tentatively concluded, in part Congress did not intend the rule to cleaning of buildings and equipment in based on the statutory direction in apply to farms in foreign countries. ensuring produce safety. section 419 to establish ‘‘minimum Moreover, the Codex Code science-based standards,’’ and in H. Consistency With Codex Guidelines recommends that ‘‘manure, biosolids recognition of the direction to pay In developing our proposed approach, and other natural fertilizers which are special attention to minimizing we considered the recommendations of untreated or partially treated may be recordkeeping burden and collection of relevant Codex guidelines, specifically, used only if appropriate corrective information, that the most appropriate the Codex Code of Hygienic Practice for actions are being adopted to reduce approach for this proposed rule is to Fresh Fruits and Vegetables (CAC/RCP microbial contaminants, such as establish standards of the type described 53–2003) (the Codex Code). Many of the maximizing the time between in section D above. We are not provisions proposed in this rule are application and harvest of fresh fruits proposing to require farms to conduct parallel to or consistent with the and vegetables’’ (Section 3.2.1.2 of the operational assessments or to develop recommendations in the Codex Code. Codex Code). The recommendation to food safety plans akin to similar For example, like our proposed consider maximizing time between requirements for facilities subject to approach of focusing on biological application of untreated amendments section 418 of FSMA or our juice hazards, the Codex Code (while and harvest is reflected in proposed HACCP or seafood HACCP regulations. intended to help control microbial, provisions described in section V.F. of We acknowledge that operational chemical and physical hazards this document, in particular proposed assessments and food safety plans have associated with production of fresh § 112.56, which stipulates application

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intervals for different biological soil routinely or under specific conditions as contamination rate is 1 in 100, and 96 amendments of animal origin. a strategy to minimize known or percent when the contamination rate is The Codex Code also recommends reasonably foreseeable hazards. While 1 in 10 (Ref. 57). Both industry and FDA that ‘‘existing practices should be not widely adopted, product testing is survey data indicate that contamination reviewed to assess the prevalence and being used by some in the produce rates in produce (melons, greens, likelihood of uncontrolled deposits of industry. Some produce buyers for retail tomatoes), while variable, are typically animal faeces coming into contact with distributors require routine microbial very low (Ref. 58. Ref. 59). In addition, crops. Considering this potential source testing of product as a condition of sale microbial testing can only detect the of contamination, efforts should be in their purchasing specifications (Ref. pathogens that the analytical procedures made to protect fresh produce growing 52). Individual fresh-cut produce are designed to detect. Testing instead areas from animals. As far as possible, companies began product testing in for indicator organisms may be a viable domestic and wild animal should be response to the 2006 E. coli O157:H7 option, but is not without challenges, as excluded from the area’’ (Section 3.1 of outbreak associated with bagged fresh discussed in section V.E.2. of this the Codex Code). We believe that the spinach (Ref. 53). At least one company document. proposed provisions in § 112.82, which is reported to use product testing to Another factor affecting the utility of requires an adequate waiting period verify the efficacy of good agricultural product testing for pathogens as a between grazing by working animals practices programs and to prevent control measure is that FDA and harvesting when under the contaminated product lots from entering recommends, and it is generally circumstances there is a reasonable commerce (Ref. 52). The California industry practice, to hold any batch of probability that grazing or working Leafy Greens Marketing Agreement product from which samples are taken animals will contaminate covered requires crop testing for E. coli O157:H7 for testing to prevent the need for a produce, and § 112.83, which requires and Salmonella spp. whenever a crop recall should the test results monitoring for wild animal intrusion has been directly contacted with water demonstrate the presence of a pathogen. and assessment of safety of harvest that exceeds the agreements’ acceptance With a highly perishable product as is where significant intrusion is evident if criteria for generic E. coli (Ref. 31). the case for most produce, storing under the circumstances there is a product during such analyses would Product testing, especially reasonable probability that animal significantly reduce the shelf-life of the microbiological testing, for process intrusion will contaminate covered product. For these reasons, we control purposes presents several produce, are consistent with (though not tentatively conclude that product testing challenges. Pathogen prevalence in identical to) these Codex would be impracticable as a component produce as a result of contamination recommendations. of science-based minimum standards events that occur during growing, Furthermore, the proposed proposed in this rule except as set forth harvesting, packing, or holding on farms requirements related to the maintenance in proposed subpart M under certain are generally temporally intermittent, of records (described in section V.O. of circumstances for sprouts. this document) are in concert with the non-homogeneous in a lot or a field, and Codex documentation and records at low concentrations (Ref. 54). J. Effective Dates recommendations for growers and Therefore, unlike some processed foods We are proposing that the effective packers, which states: ‘‘Growers should that may consist of batches of date of this rule would be 60 days after keep current all relevant information on homogeneous material (e.g., bulk flour, the date of publication of the final rule agricultural activities such as the site of milk, juice), produce are best thought of in the Federal Register with staggered production, suppliers’ information on as individual units, and while a positive compliance dates. The effective date is agricultural inputs, lot numbers of test result for one unit does raise the date that provisions in the rule affect agricultural inputs, irrigation practices, concern about the rest of the lot or the the current CFR. use of agricultural chemicals, water field subject to the same conditions, An effective date of 60 days after date quality data, pest control and cleaning procedures, processes, and practices, of publication of the final rule in the schedules for indoor establishments, any contamination present in one unit Federal Register would be consistent premises, facilities, equipment and may not have necessarily spread to with the effective dates in recent FDA containers. Packers should keep current other units. In addition, it is generally rules directed to food safety. See, e.g., all information concerning each lot such recognized that negative product test Federal Register of July 9, 2009 (74 FR as information on incoming materials results do not necessarily indicate the 33029 at 33030), establishing an (e.g. information from growers, lot absence of a hazard, particularly when effective date of September 8, 2009, for numbers), data on the quality of the hazard is present at very low levels a final rule for the prevention of processing water, pest control and is not uniformly distributed (Ref. Salmonella Enteritidis in shell eggs programmes, cooling and storage 55. Ref. 56). Sampling plans intended to during production, storage, and temperatures, chemicals used in ensure detection of contamination with transportation; and Federal Register of postharvest treatments, and cleaning a reasonable assurance of success in June 25, 2007 (72 FR 34751 at 34752), schedules for premises, facilities, produce lots or fields can be cost- establishing an effective date of August equipment and containers, etc.’’ prohibitive, and may not be effective for 24, 2007, for a final rule for current good (Section 5.7 of the Codex Code). In the use in produce. For example, for any manufacturing practice in discussion throughout section V of this given contamination rate, the manufacturing, packaging, labeling, or document, we point out where the probability of detecting Salmonella holding operations for dietary proposed provisions are consistent with increases with the number of samples supplements. these and other recommendations of the tested and it is not feasible to identify K. Compliance Dates Codex Code. low levels of contamination in an individual lot. For example, when 30 We are proposing that the compliance I. Product Testing as a Strategy To samples in a lot are tested, the dates for entities subject to the rule Control Pathogens probability of detecting Salmonella is 1 would be based on the size of a farm We considered requiring percent when the contamination rate is and the effective date of the microbiological product testing either 1 in 3000, 26 percent when the requirement, with additional flexibility

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for compliance with proposed additional flexibility is consistent with V. The Proposal provisions for water quality in § 112.44 our approach to compliance dates in A. Subpart A—General Provisions and related provisions in §§ 112.45 and recent rules directed to food safety. (See, 112.50 (specifically, 112.50(b)(5), e.g., 74 FR 33029 at 33034 and 72 FR As proposed, subpart A contains 112.50(b)(6), and 112.50(b)(7)). 34751 at 34752.) provisions that establish the scope of, The compliance date for very small The compliance date for all other and definitions applicable to, this businesses (those subject to proposed farms subject to the rule would be two regulation, and identifies who is subject part 112 and, on a rolling basis, the years from the effective date (with the to the requirements of this part. This average annual monetary value of food exception of compliance with §§ 112.44, subpart also describes the proposed sold during the previous three-year 112.45, 112.50(b)(5), 112.50(b)(6), and modified requirements and procedures period is no more than $250,000, as 112.50(b)(7), as discussed below). governing qualified exemptions from defined in proposed § 112.3(b)(1)) The compliance dates for water this rule. would be four years from the effective quality requirements in proposed 1. Comments Related to Proposed date (with the exception of compliance § 112.44 and related provisions in Provisions with §§ 112.44, 112.45, 112.50(b)(5), §§ 112.45, 112.50(b)(5), 112.50(b)(6), 112.50(b)(6), and 112.50(b)(7), as We received several comments in and 112.50(b)(7) would be two years response to the 2010 FR notice that discussed below). The compliance date beyond the compliance date for the rest for very small businesses would not be addressed issues relevant to the general of the final rule applicable to the farm scope of this proposed rule. Some in conflict with the requirement in based on its size. We recognize that section 419(b)(3)(B) of the FD&C Act for comments requested that tree crops be farms may need additional time to cope exempt from this regulation. For the regulations promulgated under with implementation of the water section 419 to apply to very small example, an apple grower asserted that quality testing, monitoring, and related apples are not as susceptible to E. coli businesses ‘‘after the date that is 2 years record-keeping provisions. This after the effective date of the final and other pathogens as are lettuce and additional compliance period would tomatoes, and therefore they should not regulation. * * *’’ because this also be expected to permit farms to requirement specifies that the be subject to the same controls and consider identifying alternatives to the restrictions. Additionally, one grower regulations shall apply after, not on, the standard in proposed § 112.44(b) and date that is 2 years after the effective stated that citrus fruits should be developing adequate scientific data or exempt because citrus fruits have not date. To provide additional flexibility to information necessary to support a small businesses, we would provide two been identified to be the source of an conclusion that the alternative would more years for very small businesses to incident of food-borne illness, a provide the same level of public health comply with the rule than is required majority of such produce does not touch protection as the standard that would be under section 419(b)(3)(B). Providing an the ground, citrus fruit are washed established in this part, and would not extended compliance period to very during the packing process, and the peel increase the likelihood that the covered small businesses as a means of is rarely consumed raw. Several produce will be adulterated under providing additional flexibility is comments from produce associations section 402 of the FD&C Act, in light of consistent with our approach to requested removal of watermelons from the farm’s covered produce, practices, compliance dates in recent rules the ‘‘melon’’ category, stating that they and conditions. The extended directed to food safety. (See, e.g., 74 FR should have their own category since 33029 at 33034 and 72 FR 34751 at compliance dates for the water quality they have a different risk profile from 34752.) testing, monitoring, and related record other melons. In addition, comments The compliance date for small keeping requirements in proposed from several tree nut growers stated that businesses (those subject to proposed §§ 112.44, 112.45, 112.50(b)(5), some tree nut commodities should have part 112 and, on a rolling basis, the 112.50(b)(6), and 112.50(b)(7) would less rigorous requirements or be exempt. average annual monetary value of food then be six years from the effective date As we explained in Section IV.C, we sold during the previous three-year for very small businesses, five years tentatively concluded that an approach period is no more than $500,000, as from the effective date for small that considers both the risk associated defined in proposed § 112.3(b)(2)) businesses, and four years from the with the commodity and that associated would be three years from the effective effective date for all other farms subject with the agricultural practices applied date (with the exception of compliance to the rule. to the crop under the conditions in with §§ 112.44, 112.45, 112.50(b)(5), The compliance dates would apply to which it is grown, would provide the 112.50(b)(6), and 112.50(b)(7), as all farms subject to the rule, including most appropriate balance between discussed below). The compliance date those farms that satisfy the requirements public health protection, flexibility, and for small businesses would not be in in proposed § 112.5 for an exemption appropriate management of different conflict with the requirement in section from most requirements of the rule, levels of risk. Under this approach, we 419(b)(3)(A) of the FD&C Act for the because such farms have modified considered available information on regulations promulgated under section requirements (proposed § 112.6) to outbreaks and contamination as well as 419 to apply to small businesses ‘‘after which they would be subject on the existing evidence on characteristics of the date that is 1 year after the effective relevant compliance date. the commodity (such as whether the date of the final regulation. * * *’’ We seek comment on these proposed commodity grows on trees or has a because this requirement specifies that implementation periods. In addition, smooth rind). This evidence informed the regulations shall apply after, not on, given that activities related to produce the proposed requirements, but we have the date that is 1 year after the effective production, harvesting, packing, and tentatively concluded that limiting the date. To provide additional flexibility to holding may be affected by the produce scope of this rule based on outbreak small businesses, we would provide two growing season, we seek comment on data or on the levels of frequency of more years than is required under whether these compliance dates pathogen detection alone would not section 419(b)(3)(A). Providing an sufficiently address any issues related to adequately address the risk of serious extended compliance period to small the seasonal nature of produce-related adverse health consequences or death. businesses as a means of providing activities. Therefore, as discussed in section

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V.A.2.a. of this document, we are proposed here. A farm or farm mixed- contact with animals or consumption of proposing to cover apples, citrus fruits, type facility that washes its own animals as food, by farm practices in watermelons, and tree nuts in this covered produce would be harvesting producing and harvesting fruits and proposed rule. Because the scope and within the farm definition and therefore vegetables does not merit imposition of stringency of the regulatory that activity would be covered by this new regulatory requirements at this requirements depends in several cases proposed rule unless another exemption time. Therefore, this proposal is limited on the types of practices employed applied. However, a farm mixed-type to produce for use as human food. within operations, producers of facility that washes covered produce not Produce that is intended for use as different commodities who use different grown on that farm or another farm animal food would not be subject to the practices will not be subject to all of the under the same ownership for requirements of this rule. This is same controls and restrictions. We seek distribution into commerce would be reflected in the title of the proposed rule comment on our proposed approach. engaging in an activity outside the farm (‘‘Standards for the Growing, Because our regulatory approach does definition (i.e., a manufacturing/ Harvesting, Packing, and Holding of not depend on categorizing processing activity). Such activities Produce for Human Consumption’’) and commodities based on risk profiles, we would not be subject to this rule but its proposed location in Chapter I, do not see the need to distinguish instead would be subject to section 418 Subchapter B of Title 21, Code of among fruits, including watermelons, on of the FD&C Act. Federal Regulations (‘‘Food for Human this basis. We do note, however, that in As discussed in section I of this Consumption’’). proposed § 112.1(b)(1) we have listed document and the QAR, produce is As proposed, § 112.1 establishes the watermelons separately from other vulnerable to contamination by scope of food that is subject to this rule. melons. While we propose to cover tree pathogens, which can occur at various Under proposed § 112.1(a), food that nuts that do not meet the criteria we points during growing, harvesting, meets the definition of produce in propose for ‘‘rarely consumed raw’’ (see packing, and holding. Although § 112.3(c) and that is a raw agricultural section V.A.2.a) in this proposed rule, contamination usually occurs in low commodity (RAC) as defined in section such as walnuts and almonds, we doses, even low doses of some of these 201(r) of the FD&C act, would be recognize that many of these tree nuts harmful pathogens can result in human covered by part 112, unless it is receive commercial processing to illness or death (Ref. 60). Thus, if excluded by § 112.2. Section 201(r) adequately reduce pathogens and, thus, produce is contaminated with a defines ‘‘raw agricultural commodity’’ may be eligible for an exemption under pathogen, there is a reasonable as any food in its raw or natural state, proposed § 112.2(b) (discussed in possibility that the amount of the including all fruits that are washed, section V.A.2.a. of this document). Our pathogen present will be enough to colored, or otherwise treated in their main food safety concerns relevant to cause serious adverse health unpeeled natural form prior to on-farm growing, harvesting, packing, consequences or death to a consumer marketing.’’ This includes produce and holding of tree nuts pertain to those even without an extended time period RACs grown domestically and produce tree nuts that would be sold raw and before consumption for the pathogen to RACs that will be imported or offered untreated. We request comments on our grow and multiply. In addition, even in for import in any State or territory of the treatment of tree nuts in this proposal. cases where the delivery time may not United States, the District of Columbia, or the Commonwealth of Puerto Rico. We also received comments regarding exceed 24–30 hours, consumers and other recipients may store produce (in a As discussed in section III and IV of this various activities performed on produce document, FDA tentatively concludes in relation to the scope of this proposed refrigerator or otherwise) thereafter and not consume it immediately, allowing that proposed § 112.1(a) is consistent rule. One comment stated that with section 419(a)(1)(A) of the FD&C ‘‘processing’’ should not refer to rinsing additional time for pathogen growth. Therefore, FDA tentatively concludes it Act, which directs us to establish heads of lettuce or bunches of greens science-based minimum standards for would not be appropriate to exempt any before they are packed for market, but the safe production and harvesting of farms from this proposed rule based on rather should be defined specifically to those types of fruits and vegetables that the speed of their deliveries to the include other processes that appear to are raw agricultural commodities for consumer. involve additional risk to the consumer. which the Secretary has determined that Some comments suggested that no 2. Proposed Requirements such standards minimize the risk of grower should be exempt from these a. Food Covered by This Rule serious adverse health consequences or food safety regulations, whereas another death. stakeholder stated that the produce This proposal is applicable to certain We propose to establish a definition safety standards must be very clear as to farm activities performed on certain of ‘‘produce’’ in proposed § 112.3(c) (see what constitutes produce processing produce for use as human food. Section section V.A.2.b.iii. of this document) versus produce preparation for market 105 of FSMA does not specify whether that would be relevant to the use of that acceptance and that Part 110 should be the rulemaking conducted under that term in proposed § 112.1. ‘‘Produce’’ reserved for situations where extensive section should apply to human food, would mean any fruit or vegetable commingling, cutting, washing and animal food, or both. The general (including specific mixes or categories bagging of produce are practiced. rulemaking requirements in of fruits and vegetables) grown for Finally, a comment suggested that 419(a)(1)(A), (b)(1), and (c)(1)(A) human consumption, and would growers who deliver produce to the authorize FDA to establish standards for include mushrooms, sprouts consumer within 24–30 hours should be the safe production and harvesting of (irrespective of seed source), peanuts, exempt from this regulation. As fruits and vegetables that are raw tree nuts and herbs. Within the discussed in section III.F. of this agricultural commodities for which the definition of ‘‘produce,’’ we would document and further in section Secretary has determined that such further define ‘‘fruit’’ and ‘‘vegetable’’ to V.A.2.b.i below, this proposed rule standards minimize the risk of serious reflect the common meanings of those would apply to activities of farms and adverse health consequences or death. terms. farm mixed-type facilities that are FDA tentatively concludes that the risk We would define a fruit as the edible within the definition of ‘‘farm’’ posed to animals, and to humans from reproductive body of a seed plant or tree

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nut (such as apple, orange and almond), holding of mushrooms are generally part, as ‘‘a hard-shelled dry fruit or seed such that fruit would mean the similar to those for other produce (Ref. with a separable rind or shell and harvestable or harvested part of a plant 67). Accordingly, we tentatively interior kernel * * *’’ (Ref. 61). In developed from a flower. This is conclude that it is reasonable to include addition, the produce industry appears consistent with the common meaning of mushrooms in the proposed definition to recognize peanuts and tree nuts as the term ‘‘fruit,’’ as demonstrated by the of ‘‘vegetable.’’ produce, as demonstrated by various Merriam-Webster Dictionary definition Sprouts meet the definition of industry documents (Ref. 65. Ref. 66). of ‘‘fruit’’ to mean, in relevant part ‘‘the ‘‘vegetable’’ above from the Merriam- Moreover, the hazards and controls usually edible reproductive body of a Webster Dictionary (Ref. 61). In relevant to minimizing serious adverse seed plant; especially: One having a addition, sprouts are classified as health consequences or death during the sweet pulp associated with the seed vegetables by USDA AMS under PACA growing, harvesting, packing, and * * * a succulent plant part (as the (Ref. 63). The USDA 2010 Dietary holding of peanuts and tree nuts are petioles of a rhubarb plant) used chiefly Guidelines for Americans also include generally similar to those for other in a dessert or sweet course * * * a ‘‘bean sprouts’’ in the ‘‘vegetable’’ food produce (Ref. 69. Ref. 70). Specifically, product of fertilization in a plant with group (Ref. 64). In addition, the produce peanuts and tree nuts share the its modified envelopes or appendages; industry appears to recognize sprouts as significant hazard of pathogens with specifically: The ripened ovary of a seed vegetables, as demonstrated by various other covered produce. To a significant plant and its contents * * *’’ (Ref. 61). industry documents (Ref. 68). Moreover, extent, this hazard is eliminated during We would define a vegetable as the the hazards and controls relevant to manufacturing/processing operations, edible part of an herbaceous plant (such minimizing serious adverse health such as roasting, by facilities subject to as cabbage and potato) or fleshy fruiting consequences or death during the section 418 of the FD&C Act, rather than body of a fungus (such as white button growing, harvesting, packing, and through measures taken by farms subject and shiitake) grown for an edible part, holding of sprouts are generally similar to this regulation. However, as such that vegetable would mean the to those for other produce, but with discussed in section V.A.2.a below, harvestable or harvested part of any additional controls necessary due to the peanuts meet our proposed criteria for plant or fungus whose fruit, fleshy unique risks presented by sprouts (Ref. ‘‘rarely consumed raw’’ and therefore fruiting bodies, seeds, roots, tubers, 160. Ref. 161) (see section V.M of this would be exempt from this proposed bulbs, stems, leaves, or flower parts are document). Accordingly, we tentatively rule. Tree nuts that do not meet the used as food and includes mushrooms, conclude that it is reasonable to include criteria for ‘‘rarely consumed raw’’ sprouts, and herbs (such as basil and sprouts in the proposed definition of would also be exempt from this cilantro). ‘‘vegetable.’’ Herbs meet the definition proposed regulation if you establish and This is consistent with the common of ‘‘vegetable’’ above from the Merriam- keep documentation that demonstrates meaning of the term ‘‘vegetable,’’ as Webster Dictionary (Ref. 61). Herbs are that the recipient of the produce demonstrated by the Merriam-Webster generally consumed in combination performs commercial processing in Dictionary definition of ‘‘vegetable’’ to with other foods (for example, in salads accordance with proposed § 112.2(b)(1). mean, in relevant part, ‘‘a usually or as garnishes) rather than consumed as For tree nuts that remain subject to the herbaceous plant (as the cabbage, bean, distinct servings, but they nonetheless proposed rule, the kinds of measures or potato) grown for an edible part that satisfy the dictionary definition of necessary to minimize the risk of known is usually eaten as part of a meal; also: ‘‘vegetable.’’ In addition, USDA or reasonably foreseeable biological Such an edible part * * *’’ (Ref. 61). considers herbs to be covered hazards are the same as those in We are proposing to specify in the commodities under PACA, such that subparts A through O of this proposed definition of produce that it includes they are classified as ‘‘herbs’’ but fall rule (e.g., control of soil amendments, mushrooms, sprouts, peanuts, tree nuts within the broader category of ‘‘fresh agricultural water, worker hygiene). and herbs, to leave no doubt about the fruits and fresh vegetables’’ (Ref. 63). In Accordingly, we conclude it is status of these foods. Taxonomically, a addition, the produce industry appears reasonable to include peanuts and tree mushroom is a fungus (Ref. 62). For to recognize herbs as vegetables, as nuts in the proposed definition of regulatory purposes in the United demonstrated by various industry produce as a ‘‘fruit.’’ We recognize that States, however, mushrooms have documents (Ref. 66). Moreover, the peanuts and tree nuts are not covered generally been treated as vegetables. hazards and controls relevant to Mushrooms are classified as vegetables minimizing serious adverse health commodities under PACA ((Ref. 63. Ref. by USDA AMS under the Perishable consequences or death during the 71) and that the USDA 2010 Dietary Agricultural Commodities Act (7 U.S.C. growing, harvesting, packing, and Guidelines for Americans consider nuts 499a–499t) (PACA) (Ref. 63), using a holding of herbs are generally similar to a ‘‘protein food’’ rather than as part of definition stating in relevant part that those for other produce(Ref. 13. Ref. 50). the ‘‘fruits and vegetables’’ group for the ‘‘fresh fruits and fresh vegetables’’ Accordingly, we tentatively conclude purpose of providing dietary advice means ‘‘all produce in fresh form that it is reasonable to include herbs in (Ref. 72); however, in light of the generally considered as perishable fruits the proposed definition of ‘‘vegetable.’’ treatment of peanuts and tree nuts as and vegetables * * *’’ (21 CFR 46.2(u)). Peanuts and tree nuts both meet the produce in common usage and in the The USDA 2010 Dietary Guidelines for definition of ‘‘fruit’’ above from the produce industry, and the commonality Americans also include mushrooms in Merriam-Webster Dictionary (Ref. 61). of on-farm hazards and controls for the ‘‘vegetable’’ food group (Ref. 64). In The Merriam-Webster Dictionary peanuts, tree nuts, and other produce addition, the produce industry appears defines ‘‘peanut,’’ in relevant part, as ‘‘a (Ref. 70. Ref. 69), we tentatively to recognize mushrooms as vegetables, low-branching widely cultivated annual conclude that it is reasonable to include as demonstrated by various industry herb * * * of the legume family with peanuts and tree nuts in the proposed documents (Ref. 65. Ref. 66). Moreover, showy yellow flowers having a definition of produce as ‘‘fruits.’’ the hazards and controls relevant to peduncle which elongates and bends We propose to specify in the minimizing serious adverse health into the soil where the ovary ripens into definition of ‘‘produce’’ that the term consequences or death during the a pod containing one to three oily edible would not include food grains, meaning growing, harvesting, packing, and seeds * * *,’’ and ‘‘nut,’’ in relevant the small, hard fruits or seeds of arable

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crops, or the crops bearing these fruits cherries, citrus (such as clementine, propose that these listed produce be or seeds, that are grown and processed grapefruit, lemons, limes, mandarin, excluded from the requirements of this for use as meal, flour, baked goods, oranges, tangerines, tangors, and uniq rule. Studies have shown that the cereals and oils rather than for fresh fruit), cucumbers, curly endive, garlic, numbers of microorganisms of public consumption (including cereal grains, grapes, green beans, guava, herbs (such health significance (such as Listeria pseudo cereals, oilseeds and other as basil, chives, cilantro, mint, oregano, monocytogenes, Salmonella, shiga plants used in the same fashion). and parsley), honeydew, kiwifruit, toxin-producing E. coli) are significantly Examples of food grains would include lettuce, mangos, other melons (such as reduced in produce by a variety of barley, dent- or flint-corn, sorghum, canary, crenshaw and persian), relatively moderate heat treatments (Ref. oats, rice, rye, wheat, amaranth, quinoa, mushrooms, nectarine, onions, papaya, 75. Ref. 76. Ref. 77. Ref. 78). Therefore, buckwheat, cotton seed, and soybean. passion fruit, peaches, pears, peas, we tentatively conclude that the cooking Our proposed definition of ‘‘food peppers (such as bell and hot), that the produce listed in § 112.2(a)(1) grains’’ is consistent with the common pineapple, plums, plumcot, radish, receive before they are consumed, meaning of the term ‘‘grain’’ when used raspberries, red currant, scallions, snow whether commercially or by the in the context of food, as demonstrated peas, spinach, sprouts (such as alfalfa consumer, would be sufficient to by the Merriam-Webster Dictionary and mung bean), strawberries, summer minimize the risk of serious adverse definition of ‘‘grain’’ to mean, in squash (such as patty pan, yellow and health consequences or death. relevant part, ‘‘a seed or fruit of a cereal zucchini), tomatoes, walnuts, watercress We note that all produce commodities grass * * * the seeds or fruits of various and watermelon. are and will continue to be covered food plants including the cereal grasses The list of fruits and vegetables under the adulteration provisions and and in commercial and statutory usage provided in proposed § 112.1(b)(1) is other applicable provisions of the other plants (as the soybean) * * * not an exhaustive list of produce Federal Food, Drug, and Cosmetic Act plants producing grain * * *’’ (Ref. 61). covered by this rule. This section is and applicable implementing In addition, the industry appears to intended simply to provide examples of regulations, irrespective of whether they recognize grains as a separate produce commonly consumed in the are included within the scope of this commodity group from produce, as United States that would be included proposed rule. demonstrated by various industry within the scope of this regulation. The We developed this list in proposed documents regarding ‘‘produce’’ and absence of a specific fruit or vegetable § 112.2(a)(1) of produce that rarely is ‘‘fruits and vegetables’’ that do not from this list does not indicate that it is consumed raw by analyzing include grains (Ref. 65. Ref. 66). Grains not covered, except where the specific consumption data on selected produce are not covered commodities under fruit or vegetable is exempted from the commodities using data available from the National Health and Nutrition PACA (Ref. 63). The USDA 2010 Dietary regulation by § 112.2(a)(1). We request Examination Survey (NHANES) and Guidelines for Americans treat grains as comment on the examples of fruits and other resources (Ref. 79). We looked at a separate food group from the ‘‘fruits vegetables listed in 112.1(b)(1). Proposed § 112.1(b)(2) would clarify the percentage of the population and vegetables’’ food group (Ref. 73). In that mixes of intact fruits and vegetables consuming the produce commodity in addition, the hazards and controls (such as fruit baskets) are also covered fresh form as well as the percentage of relevant to minimizing serious adverse by this rule. Proposed § 112.1(b)(2) is eating occasions on which the produce health consequences or death during the consistent with section 419(a)(1)(A) of commodity is eaten uncooked (Ref. 79. growing, harvesting, packing, and the FD&C Act, which includes mixes or Ref. 80). As explained further in a memo holding of grains are significantly categories of fruits and vegetable RACs to the record, we found that artichokes, different from those relevant to fruits as part of the rulemaking requirement asparagus, beets, bok choy, brussels and vegetables (Ref. 74). Specifically, we are implementing through this sprouts, cranberries, eggplant, figs, the hazards of concern in grains are proposed rule. ginger root, lima beans, okra, plantains, primarily chemical hazards such as As proposed, § 112.2(a) identifies potatoes, rhubarb, sweet corn, sweet mycotoxins and pesticides, rather than three types of produce not covered by potatoes, turnips, and yams are eaten biological hazards (which, as discussed this rule. First, proposed § 112.2(a)(1) uncooked by less than 0.1% of the U.S. in section IV.B. of this document, are provides an exclusion for produce that population and are consumed uncooked the only hazards we currently propose is rarely consumed raw. FDA proposes on less than 0.1% of eating occasions to address in this rule, as they are the to establish the following exhaustive list (Ref. 79). Other commodities, including most significant hazards affecting of specific fruits and vegetables that black-eyed peas, chick-peas, collard covered produce), because grains are would be exempt under this provision: greens, crabapples, kale, kidney beans, milled and/or cooked such that arrowhead, arrowroot, artichokes, lentils, parsnips, peanuts, pinto beans, pathogens that may be present are asparagus, beets, black-eyed peas, bok pumpkin, rutabaga, sugarbeet, taro, reduced to a level where they are choy, brussels sprouts, chick-peas, water chestnut, and winter squash unlikely to present a risk to public collard greens, crabapples, cranberries, (which includes both acorn and health for most products. Accordingly, eggplant, figs, ginger root, kale, kidney butternut squash) are included in the we tentatively conclude that it is beans, lentils, lima beans, okra, NHANES data set but their categories of reasonable to exclude grains from the parsnips, peanuts, pinto beans, reported consumption do not include definition of ‘‘produce.’’ plantains, potatoes, pumpkin, rhubarb, ‘‘uncooked,’’ indicating that they are not Proposed § 112.1(b)(1) lists specific rutabaga, sugarbeet, sweet corn, sweet consumed uncooked in any measurable examples of produce covered by this potatoes, taro, turnips, water chestnuts, quantity (Ref. 79). Still other rule. Such covered produce would winter squash (acorn and butternut commodities on the list, namely, include almonds, apples, apricots, squash), and yams. Because these listed arrowhead and arrowroot, are not aprium, asian pear, avocados, babaco, fruits and vegetables are almost always identified in the NHANES data set as bamboo shoots, bananas, Belgian consumed only after being cooked, being eaten in the United States in any endive, blackberries, blueberries, which is a kill-step that adequately form, uncooked or otherwise (Ref. 79). broccoli, cabbage, cantaloupe, reduces the presence of microorganisms Other references indicated that those carambola, carrots, cauliflower, celery, of public health significance, we commodities are typically consumed

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cooked (Ref. 63. Ref. 82). We request therefore be subject to this rule without eligible for an exemption from the comment on the proposed criteria used an exemption. To the extent that there requirements of this part (except for for identifying the commodities that are is any difference between produce ‘‘for subparts A, Q, and O). Examples of rarely consumed raw. Further, we personal consumption’’ and produce commercial processing that adequately request comment on additional ‘‘consumed on the farm or another farm reduces the presence of microorganisms commodities that should be considered under the same ownership,’’ FDA of public health significance are for inclusion in the list in 112.2(a)(1). proposes to exclude produce for either processing in accordance with the As noted above, we analyzed type of consumption from this proposed requirements of part 113, part 114, or consumption data on selected produce rule. part 120; treating with a validated commodities to generate this list. We Third, § 112.2(a)(3) proposes to process to eliminate spore-forming acknowledge that there may be exclude produce that is not a raw microorganisms (such as processing to additional commodities that would agricultural commodity from this produce tomato paste or shelf-stable meet these criteria that we did not proposed rule. For example, this would tomatoes); and processing such as analyze. Also, we anticipate that, in the exclude ‘‘fresh-cut’’ produce, which is refining or distilling produce into case of some commodities, the subject to current part 110 and to products such as sugar, oil, spirits, or consumption rates in the United States section 418 of the FD&C Act as similar products. As discussed in may be too low for the NHANES data applicable (Ref. 83). This is consistent section IV.C. of this document, FDA and other data sources used in our with section 419(a)(1)(A) of the FD&C tentatively concludes that such analysis to support a conclusion that the Act, which directs FDA to ‘‘establish commercial processing significantly commodity is rarely consumed raw science-based minimum standards for minimizes the risk of serious adverse using our proposed criteria. We request the safe production and harvesting of health consequences or death associated comment on additional sources of those types of fruits and vegetables with biological hazards for such information and/or criteria that should * * * that are raw agricultural produce, such that the produce can be be applied in such cases. commodities * * *.’’ This is also considered to be low risk and the We also request comment on the consistent with the application of this imposition of the requirements in this inclusion of commodities that our rule to activities within the farm proposed rule is not warranted. We note analysis indicates are rarely consumed definition. In section V.A.2.b.i of this that such produce is and will continue raw, but may not be prepared in a document, we discuss how we to be covered under the adulteration manner that would kill microbial considered how the activities of farms provisions and other applicable contaminants, should they be present on relate to the concept of a RAC and provisions of the Federal Food, Drug, the food. For example, we have tentatively concluded that the farm and Cosmetic Act and applicable included asparagus, bok choy, and definition and related definitions in this implementing regulations, irrespective cranberries in the list of commodities proposed rule should be revised based of whether it is included within the that will be exempt from the on the concept that RACs are the scope of this proposed rule. requirements of this rule in proposed essential products of farms. As proposed, to qualify for the § 112.2(a)(1) because the NHANES data Accordingly, the definitions proposed § 112.2(b) exemption, proposed indicated that these commodities are here (for the terms farm, mixed-type § 112.2(b)(2) would require you to consumed uncooked by less than 0.1% facility, harvesting, manufacturing/ establish and keep documentation of the of the U.S. population and are processing, packing, and holding) reflect identity of the recipient of the covered consumed uncooked on less than 0.1% the tentative conclusion that activities produce that performs the commercial of eating occasions (Ref. 79). However, involving RACs that farms traditionally processing in accordance with the we are concerned that the method of do for the purposes of growing their requirements of proposed subpart O. food preparation that these commodities own RACs, removing them from the FDA tentatively concludes that such may be subjected (for example, stir growing areas and preparing them for records are necessary for the efficient frying bok choy) to prior to use as a food RAC, and for packing, enforcement of the FD&C Act. Without consumption may not constitute a kill- holding and transporting them, should such records, FDA would have no way step that adequately reduces the all be within the definition of ‘‘farm.’’ to assess whether farms are complying presence of microorganisms of public This is the case even if the same with the terms of this exemption. In health significance. We request activities off-farm would be considered addition, proposed § 112.2(b)(3) would comment on our tentative conclusions to be ‘‘manufacturing/processing’’ clarify that the requirements of subparts about these commodities and others because those activities involve A and Q apply to such produce because proposed for exclusion in § 112.2(a)(1). ‘‘making food from one or more subpart A includes relevant provisions Second, § 112.2(a)(2) proposes to ingredients, or synthesizing, preparing, such as the scope of this rule and exempt produce that is produced by an treating, modifying or manipulating definitions, and Q contains provisions individual for personal consumption or food.’’ This special classification of on- relating to compliance and enforcement. produced for consumption on the farm farm activities, however, should only It is important to note that any of the or another farm under the same apply to RACs because only RACs, not exemptions in proposed § 112.2 are only ownership. With respect to the processed foods, are the essential applicable to the produce specified in exemption for personal consumption, products of farms. For all of these the exemption. In other words, a section 419(g) of the FD&C Act reasons, RACs are a logical and covered farm may not rely on these specifically exempts food produced by appropriate focus for these produce exemptions for all of its covered an individual for personal consumption safety standards. produce simply because a subset of that from this rulemaking, and proposed In addition to these three exemptions produce is rarely consumed raw; is for § 112.2(a)(2) implements this exclusion. mentioned above, under the conditions personal or on-farm consumption; is not With respect to the exclusion for specified in § 112.2(b), we propose to a RAC; or will receive the requisite produce for consumption on the farm or allow covered produce which receives commercial processing; in those another farm under the same ownership, commercial processing that adequately instances, only the subset that meets the such activities are within the definition reduces the presence of microorganisms relevant exemption criteria would be of farm that we propose here, and would of public health significance to be exempt from this proposed rule. For

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example, if you own or operate a farm the purpose of the produce safety rule processed food into account, including that produces both tomatoes that will be have some differences relative to the section 417(f) of the FD&C Act (21 processed into tomato paste, and current definitions established in the U.S.C. 350f(f)), establishing notification tomatoes that will not receive any section 415 registration regulations. In requirements for reportable foods that commercial processing to adequately the near future, we plan to address how do not apply to fruits and vegetables reduce pathogens, and you do not we will coordinate the definitions in the that are RACs; section 418(m) of the qualify for any other exemption, you section 415 registration regulations with FD&C Act, which authorizes FDA to would be subject to the rule when you the definitions we are proposing for the exempt or modify the requirements for grow, harvest, pack or hold those purpose of the produce safety proposed compliance under section 418 with tomatoes that will not be processed to rule. respect to facilities that are solely adequately reduce pathogens. Likewise, In developing these proposed engaged in the storage of RACs other if you produce both artichokes and definitions, we considered how the than fruits and vegetables intended for lettuce, you would be subject to the rule activities of farms relate to the statutory further distribution or processing; and when you grow, harvest, pack or hold concepts of ‘‘raw agricultural section 204(d)(6)(D) of FSMA (21 U.S.C. lettuce, but you would not be subject to commodity’’ and ‘‘processed food.’’ The 2223(d)(6)(D)), which contains special the rule when you grow, harvest, pack, FD&C Act defines ‘‘raw agricultural provisions for commingled RACs or hold artichokes. commodity’’ and ‘‘processed food’’ in applicable to FDA’s authority under We request comment on proposed relation to each other, and identifies section 204 of FSMA to establish §§ 112.1 and 112.2, including the certain activities that transform a raw additional recordkeeping requirements specific examples of produce that would agricultural commodity (RAC) into a for high risk foods. be covered by the rule; the list of processed food and others that do not. The term ‘‘raw agricultural produce that would not be covered by Section 201(r) of the FD&C Act (21 commodity’’ and similar terms also the rule because it is rarely consumed U.S.C. 321(r)) defines ‘‘raw agricultural appear in other Federal statutes. While raw; and the proposed exemption for commodity’’ to mean ‘‘any food in its these statutes are not implemented or produce that receives commercial raw or natural state, including all fruits enforced by FDA and do not directly processing, including the types of that are washed, colored, or otherwise impact the interpretation of the processing that should qualify for this treated in their unpeeled natural form definitions in sections 201(r) and exemption. prior to marketing.’’ Section 201(gg) of 201(gg) of the FD&C Act, they do the FD&C Act (21 U.S.C. 321(gg)) b. Definitions defines ‘‘processed food’’ to mean ‘‘any provide some suggestions about what Proposed § 112.3 would establish the food other than a raw agricultural ‘‘raw agricultural commodity’’ and definitions of terms for purposes of part commodity and includes any raw related concepts can mean in various 112. To the extent possible, the new agricultural commodity that has been circumstances. For example, the definitions proposed in § 112.3 are subject to processing, such as canning, Secretary of Transportation may consistent with the common meanings cooking, freezing, dehydration, or prescribe commercial motor vehicle of these terms as well as the definitions milling.’’ In addition, section safety standards under 49 U.S.C. 31136, of the terms in other food safety 201(q)(1)(B)(i)(II) of the FD&C Act but the Motor Carrier Safety regulations (see, e.g., current § 110.3 and (which defines pesticide chemicals) Improvement Act of 1999 (Pub. L. 106– § 111.3) and other applicable sources. contains the following language 159, title II, Sec. 229, Dec. 9, 1999), as As proposed in § 112.3(a), to provide regarding activities that do not added and amended by the Safe, clarity and consistency, the definitions transform a RAC into a processed food: Accountable, Flexible, Efficient and interpretations of terms in section ‘‘the treatment [with pesticide Transportation Equity Act: A Legacy for 201 of the FD&C Act will apply to such chemicals] is in a manner that does not Users (Pub. L. 109–59, title IV, Sec. terms when used in part 112. change the status of the food as a raw 4115, 4130, Aug. 10, 2005), provided an agricultural commodity (including exemption from maximum driving or i. Definitions of ‘‘Farm,’’ ‘‘Mixed-Type treatment through washing, waxing, on-duty times for drivers transporting Facility,’’ and Related Activities fumigating, and packing such ‘‘agricultural commodities’’ or farm We are proposing to establish an commodities in such manner).’’ supplies within specific areas during inter-related series of definitions in this The status of a food as a RAC or planting and harvest periods. In that proposed rule that, collectively, would processed food is relevant for many circumstance, ‘‘agricultural commodity’’ address several issues related to the different purposes under the FD&C Act, is defined as ‘‘any agricultural scope of establishments (namely, including section 419(a)(1)(A) of the commodity, non-processed food, feed, ‘‘farms’’) that would be subject to the FD&C Act, which authorizes FDA to fiber, or livestock * * * and insects’’ rule. These inter-related definitions establish minimum science-based (49 U.S.C. 31136 note). Another include two definitions for types of standards applicable to certain fruits example is 19 U.S.C. 1677(4)(E), which establishments (i.e., ‘‘farm’’ and ‘‘mixed- and vegetables that are RACs. For provides for certain circumstances in type facility’’) and five definitions for example, under 403(w) of the FD&C Act which producers or growers of raw types of activities (i.e., ‘‘harvesting,’’ (21 U.S.C. 343(w)), labeling agricultural products may be considered ‘‘holding,’’ ‘‘manufacturing/processing,’’ requirements related to major food part of the industry producing ‘‘packaging,’’ and ‘‘packing’’) conducted allergens apply to processed foods but processed foods made from the raw on farms and mixed-type facilities. do not apply to RACs. Under sections agricultural product for the purposes of These proposed definitions are based 201(q), 403(k), 403(l), and 408 of the customs duties and tariffs related to on definitions already established in our FD&C Act (21 U.S.C. 321(q), 343(k), such processed foods. In that regulations (e.g., in § 1.227 in the 343(l), and 346a), the status of a food as circumstance, ‘‘raw agricultural regulations for Registration of Food a RAC has an impact on the manner in product’’ is defined as ‘‘any farm or Facilities, established under section 415 which pesticide chemicals and their fishery product’’ (19 U.S.C. 1677(4)(E)). of the FD&C Act; hereinafter the section residues are regulated. FSMA created These statutes are informative in that 415 registration regulations). However, more provisions in the FD&C Act and they suggest that the ‘‘raw agricultural the definitions that we are proposing for elsewhere that take status as a RAC or commodity’’ concept describes and

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signifies the products of farms in their or not various activities transform RACs EPA/FDA Policy Interpretation. (See natural states, or, in other words, that into processed foods. FDA and EPA Guidance for Industry: Antimicrobial which a farm exists to produce on a jointly issued a legal and policy Food Additives, July 1999 (hereinafter basic level. interpretation of the agencies’ ‘‘Antimicrobial Guidance’’) (Ref. 84)). Because the status of a food as a RAC jurisdiction under the FD&C Act over Table 1 summarizes activities that cause or processed food is of great importance antimicrobial substances used in or on food RACs to become processed foods in defining the jurisdiction of FDA and food (hereinafter the ‘‘1998 Joint EPA/ and activities that do not change the the U.S. Environmental Protection FDA Policy Interpretation’’) (63 FR status of a food RAC, as set out in the Agency (EPA) over antimicrobial 54532, October 9, 1998). In 1999, FDA 1998 Joint EPA/FDA Policy substances, FDA and EPA have issued guidance addressing several of Interpretation and the Antimicrobial developed guidance regarding whether the issues discussed in the 1998 Joint 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 for- eign objects or other parts of the plant. Slaughtering animals for food and activities done to carcasses post- slaughter, including skinning, eviscerating, and quartering. Slicing. Activities that alter the general state of the commodity.

In developing the proposed synthesizing, preparing, treating, organizing principles explaining these definitions, we also considered the modifying or manipulating food.’’ In differences. definition of ‘‘manufacturing/ contrast, transforming a RAC into a In this document, we are tentatively processing’’ that FDA established in processed food seems to require meeting articulating five organizing principles § 1.227. Under § 1.227(b)(6), a threshold of altering the general state (summarized in Table 2 below) to ‘‘manufacturing/processing’’ means of the commodity (Ref. 3, section 7 and explain the basis for the proposed making food from one or more 63 FR 54532 at 54541), sometimes definitions that would classify activities ingredients, or synthesizing, preparing, referred to as transformation of the RAC on-farm and off-farm for the purpose of treating, modifying or manipulating into a new or distinct commodity (61 FR this proposed rule. In the near future, food, including food crops or 2386 at 2388). Because the activities that we plan to address how we will ingredients. Examples of transform a RAC into a processed food coordinate the definitions in the section manufacturing/processing activities are are not coextensive with the definition 415 registration regulations with the cutting, peeling, trimming, washing, of ‘‘manufacturing/processing’’ in definitions we are proposing for the waxing, eviscerating, rendering, § 1.227(b)(6), a given activity may be purpose of this proposed rule. cooking, baking, freezing, cooling, manufacturing/processing under the First Organizing Principle. The pasteurizing, homogenizing, mixing, current definition in § 1.227(b)(6) statutes we describe above, and formulating, bottling, milling, grinding, without transforming a RAC into a previous interpretations of the concepts extracting juice, distilling, labeling, or processed food. Examples of such of RACs and processed food as set forth packaging. The summary in Table 1 activities include coloring, washing, and in the 1998 Joint EPA/FDA Policy demonstrates that the activities that waxing. Interpretation and the Antimicrobial transform a RAC into a processed food The current section 415 registration Guidance, lead FDA to tentatively (and are sometimes therefore referred to regulations demonstrate that some conclude that the basic purpose of farms as ‘‘processing’’ in the context of a activities may be classified differently is to produce RACs and that RACs are food’s status as a RAC or processed on farms and off farms. For example, the essential products of farms. food) are not coextensive with the ‘‘washing’’ is an example of Second Organizing Principle. Our definition of ‘‘manufacturing/ manufacturing/processing under the second organizing principle is that processing’’ that FDA established in definition of that term in § 1.227(b)(6). activities that involve RACs and that § 1.227(b)(6) for the purposes of the However, ‘‘washing’’ produce is farms traditionally do for the purposes section 415 registration regulations. The identified as part of harvesting under of growing their own RACs, removing definition of ‘‘Manufacturing/ the farm definition in § 1.227(b)(3), so them from the growing areas, and processing’’ in that regulation includes washing on farms is harvesting rather preparing them for use as a food RAC, most food-handling activities because it than manufacturing/processing under and for packing, holding and is satisfied by any degree of ‘‘making the Section 415 registration regulations. transporting them, should all be within food from one or more ingredients, or To date, we have not articulated the definition of ‘‘farm.’’ This is because

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the basic purpose of farms is to produce Fourth Organizing Principle. Principle opts to perform activities outside the RACs (principle 1). This is the case even 2 (i.e., the special classification of on- farm definition, the establishment’s if the same activities off-farm would be farm activities) should only apply to activities that are within the farm considered to be manufacturing/ RACs grown or raised on the farm itself definition should be classified as processing, because those activities or on other farms under the same manufacturing/processing, packing, or involve ‘‘making food from one or more ownership because the essential holding in the same manner as for a ingredients, or synthesizing, preparing, purpose of a farm is to produce its own farm that does not perform activities treating, modifying or manipulating RACs, not to handle RACs grown on outside the farm definition, but the food.’’ unrelated farms for distribution into activities that are outside the farm Third Organizing Principle. Activities commerce. (For the purposes of this definition should be classified in the should be classified based in part on discussion, we refer to RACs grown or same manner as for an off-farm food whether the food operated on is a RAC raised on a farm or another farm under establishment. or a processed food, and on whether the the same ownership as a farm’s ‘‘own activity transforms a RAC into a RACs,’’ in contrast to RACs grown on a Fifth Organizing Principle. processed food. This is because farm under different ownership, which Manufacturing/processing, packing, or principle 2 (i.e., the special we refer to as ‘‘others’ RACs.’’) holding food— whether RACs or classification of on-farm activities) Activities that farms may perform on processed foods, from any source—for should only apply to RACs. A farm that others’ RACs should appropriately be consumption on the farm should remain chooses to transform its RACs into classified as manufacturing/processing, within the farm definition because processed foods should be considered to packing, or holding in the same manner otherwise farms could not feed people have chosen to expand its business as these activities are classified off-farm and animals on the farm without being beyond the traditional business of a when the RACs are to be distributed considered to have engaged in activities farm. into commerce. In general, when a farm 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 hold- ing 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 raised, or consumed on that farm or facility registration (68 FR 5378 at 5381) definitions for two types of another farm under the same ownership; and in the interim final rule on food establishments (i.e., ‘‘farm’’ and ‘‘mixed- and (ii) Facilities that manufacture/ facility registration (68 FR 58894 at type facility’’) and five types of process food, provided that all food 58906–7, 58914, 58934–8). The activities (i.e., ‘‘harvesting,’’ ‘‘holding,’’ used in such activities is consumed on proposed definition would also provide, ‘‘manufacturing/processing,’’ that farm or another farm under the as an example of such a facility, a ‘‘packaging,’’ and ‘‘packing’’), to reflect same ownership. The proposed definition of a ‘‘farm mixed-type the organizing principles articulated definition of ‘‘farm’’ is based on the facility.’’ A ‘‘farm mixed-type facility’’ immediately above and to clarify how definition already established in would be defined as an establishment those definitions apply to specific § 1.227(b) in the section 415 registration that grows and harvests crops or raises activities depending on where the regulations, except that it does not animals and may conduct other activities take place, the food used in include the statement ‘‘Washing, activities within the farm definition, but the activities, where the food comes trimming of outer leaves of, and cooling also conducts activities that require the from, and where the food is consumed. produce are considered part of establishment to be registered. This We discuss these proposed definitions harvesting.’’ The description of definition is important to include in this in this section because they are inter- harvesting activities is included in a rule because the activities of farm related; however, we propose that they separate proposed definition of mixed-type facilities that are within the appear in § 112.3(c) in alphabetical ‘‘harvesting’’ and thus would be definition of ‘‘farm’’ are potentially order with the other definitions redundant in the proposed definition of subject to this rule, as provided in discussed in section V.A.2.b.iii of this ‘‘farm.’’ proposed § 112.4. FDA would apply this document below. We are proposing to define ‘‘Mixed- proposed rule only to the ‘‘farm’’ We are proposing to define ‘‘farm’’ to type facility’’ to mean an establishment portion of these establishments’ mean a facility in one general physical that engages in both activities that are activities, and not to the ‘‘non-farm’’ location devoted to the growing and exempt from registration under section portion of their activities (which would harvesting of crops, the raising of 415 of the FD&C Act and activities that be subject to section 418 of the FD&C animals (including seafood), or both. require the establishment to be Act and therefore not subject to this The term ‘‘farm’’ includes: (i) Facilities registered. This term and its definition proposed rule, consistent with section that pack or hold food, provided that all were initially developed in the 419(h) of the FD&C Act). Put another food used in such activities is grown, preamble to the proposed rule on food way, farms and the ‘‘farm’’ portion of

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the activities of farm mixed-type involves preparing, treating, modifying, We are proposing to define facilities would be subject to this or manipulating food. ‘‘Packaging’’ to mean (when used as a proposed rule as applicable. For We are proposing to define ‘‘Holding’’ verb) placing food into a container that simplicity, FDA proposes to reference to mean the storage of food. The directly contacts the food and that the these activities collectively in proposed proposed definition would state that, for consumer receives. We are proposing to § 112.4(a) as one aspect of what makes farms and farm mixed-type facilities, use the same definition of ‘‘packaging’’ an entity a ‘‘covered farm’’ and then to holding would also include activities as is currently established in § 1.227. refer only to ‘‘covered farms’’ traditionally performed by farms for the We are proposing to define ‘‘Packing’’ throughout the proposed rule. Thus, safe or effective storage of RACs grown to mean placing food into a container references to ‘‘farms’’ and ‘‘covered or raised on the same farm or another other than packaging the food. The farms’’ throughout this proposed rule farm under the same ownership, but proposed definition would also state should be understood to include the would not include activities that that, for farms and farm mixed-type portion of a farm mixed-type facility’s transform a RAC, as defined in section facilities, packing would also include activities that are within the farm 201(r) of the FD&C Act, into a processed activities (which may include definition. food as defined in section 201(gg) of the packaging) traditionally performed by We are proposing to define the term FD&C Act. This would mean that more farms to prepare RACs grown or raised ‘‘Harvesting’’ to apply to farms and farm activities than just storage of food would on the same farm or another farm under mixed-type facilities and be defined as be classified as ‘‘holding’’ when a farm the same ownership for storage and activities that are traditionally or farm mixed-type facility performs transport, but would not include performed by farms for the purpose of those activities on its own RACs. For activities that transform a RAC, as removing raw agricultural commodities example, fumigating or otherwise defined in section 201(r) of the FD&C from the place they were grown or treating a farm’s own RACs against pests Act, into a processed food as defined in raised and preparing them for use as for the purpose of safe and effective section 201(gg) of the FD&C Act. This food. Harvesting would be limited to storage would be ‘‘holding’’ under this would mean that more activities than activities performed on raw agricultural proposed definition. However, just placing food into a container other commodities on the farm on which they fumigating or otherwise treating food than packaging would be classified as were grown or raised, or another farm against pests under other circumstances ‘‘packing’’ when a farm or farm mixed- under the same ownership. Harvesting (such as off-farm or by a farm handling type facility performs those activities on would not include activities that others’ RACs) would not be ‘‘holding’’ its own RACs. For example, packaging transform a raw agricultural commodity, food because it is not storage of food, (placing food into a container that as defined in section 201(r) of the FD&C which would remain the definition of directly contacts the food and that the Act, into a processed food as defined in holding applicable to most consumer receives) a farm’s own RACs section 201(gg) of the FD&C Act. circumstances. would be ‘‘packing’’ under this Gathering, washing, trimming of outer We are proposing to define definition because farms traditionally leaves of, removing stems and husks ‘‘Manufacturing/processing’’ to mean do this to provide greater protection for from, sifting, filtering, threshing, making food from one or more fragile RACs than would be possible if shelling, and cooling raw agricultural ingredients, or synthesizing, preparing, the RACs were placed in containers commodities grown on a farm or treating, modifying or manipulating other than the consumer container, and another farm under the same ownership food, including food crops or because this activity does not transform would be listed as examples of ingredients. The proposed definition a RAC into a processed food. However, harvesting. This proposed definition would also state that, for farms and farm packaging food under other would include the same examples of mixed-type facilities, manufacturing/ circumstances would not be ‘‘packing’’ ‘‘harvesting’’ that are currently part of processing would not include activities food because packaging is explicitly the farm definition in § 1.227(b)(3) that are part of harvesting, packing, or excluded from the definition of packing (washing, trimming of outer leaves, and holding. Under this proposed definition, applicable to most circumstances cooling) and would add other examples the expanded definitions of ‘‘packing’’ (placing food into a container other than to help clarify the scope of the and ‘‘holding,’’ and the extra category packaging). Other examples of activities definition of harvesting. ‘‘Harvesting’’ is ‘‘harvesting,’’ would apply to activities that could be packing when performed a category of activities that is only performed by farms and farm mixed- by a farm or a farm mixed-type facility applicable to farms and farm mixed-type type facilities on their own RACs. These on its own RACs include packaging or facilities. Activities that would be expanded and extra categories would packing a mix of RACs together (e.g., in ‘‘harvesting’’ when performed on a farm not apply off-farm or to foods other than a bag containing three different colored on the farm’s own RACs would be a farm’s own RACs or a farm mixed-type bell peppers, or a box of mixed produce classified differently under other facility’s own RACs. Thus, some for a community sponsored agriculture circumstances, such as at a processing activities that would otherwise be program farm share); coating RACs with facility that is not on a farm, or when manufacturing/processing would wax, oil, or resin coatings used for the performed by a farm on others’ RACs. instead be defined as packing, holding, purposes of storage or transport; placing For example, at an off-farm facility that or harvesting by virtue of being stickers on RACs; labeling packages packs tomatoes, washing the tomatoes performed by a farm or farm mixed-type containing RACs; sorting, grading, or after they are received would not be facility on its own RACs. Accordingly, culling RACs; and drying RACs for the ‘‘harvesting’’ because it is not being these activities would not be purpose of storage or transport. performed on the farm that produced manufacturing/processing because they Table 3 provides examples of how we the tomatoes (or another farm under the would already be classified into the would classify activities conducted off- same ownership). Instead, washing expanded definitions of packing or farm and on-farm (including farm tomatoes at the off-farm packing facility holding, or into the extra category of mixed-type facilities) using these would be ‘‘manufacturing,’’ because it harvesting. proposed definitions.

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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 Notes: Activities traditionally performed by farms for that only applies on farms and farm mixed-type facili- the purpose of removing RACs from growing areas ties. 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 in- clude 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 per- formed on a farm’s ‘‘own RACs’’ (a term we use to include RACs grown or raised on that farm or an- other farm under the same ownership) include gath- ering, 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 pack- Notes: Placing food in a container other than pack- aging the food (where packaging means placing food aging the food (using the same definition of pack- into a container that directly contacts the food and aging), or activities (which may include packaging) that the consumer receives). 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 cir- cumstances they are outside the farm definition. . Examples: putting individual unit cartons into a larger Examples: activities that fit the definition of packing box used for shipping, and putting articles of produce when performed on a farm’s own RACs include pack- in non-consumer containers (such as shipping crates). aging, mixing, coating with wax/oil/resin for the pur- pose of storage or transport, stickering/labeling, dry- ing for the purpose of storage or transport, and sort- ing/grading/culling. These activities, performed on a farm’s own RACs, are inside the farm definition. Activities that fit the definition of packing when per- formed on a farm on any other foods, including RACs grown or raised on a farm not under the same own- ership, include putting individual unit cartons into a larger box used for shipping, and putting articles of produce in non-consumer containers (such as ship- ping 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 per- formed 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 defini- tion 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 fumi- gating 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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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 per- formed on a farm on any other foods, including RACs grown or raised on a farm not under the same own- ership, 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 un- less done on food for consumption on the farm. Manufacturing/Processing .... Notes: Making food from 1 or more ingredients, or syn- Notes: Making food from 1 or more ingredients, or syn- thesizing, preparing, treating, modifying, or manipu- thesizing, preparing, treating, modifying, or manipu- lating food. Includes packaging (putting food in a lating food; except for things that fall into the cat- container that directly contacts food and that con- egories of harvesting, packing, or holding (see rows sumer receives). 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 wash- Examples: activities that fit the definition of manufac- ing, trimming of outer leaves, removing stems and turing/processing when performed on a farm’s own husks, sifting, filtering, threshing, shelling, cooling, RACs include slaughtering animals or post-slaughter packaging, mixing, coating, stickering/labeling, drying, operations, irradiation, cutting/coring/chopping/slicing, sorting/grading/culling not incidental to packing or canning, coating with things other than wax/oil/resin, holding, fumigating, slaughtering animals or post- drying that creates a distinct commodity, artificial rip- slaughter operations, irradiation, cutting/coring/chop- ening, cooking, pasteurizing/homogenizing, infusing, ping/slicing, canning, artificial ripening, cooking, pas- distilling, salting, smoking, grinding/milling, and freez- teurizing/homogenizing, infusing, distilling, salting, ing. These activities, performed on a farm’s own smoking, grinding/milling, and freezing. RACs, are outside the farm definition unless done on food for consumption on the farm. Activities that fit the definition of manufacturing/proc- essing 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, mix- ing, coating, stickering/labeling, drying, sorting/grad- ing/culling not incidental to packing or holding, fumi- gating, slaughtering animals or post-slaughter oper- ations, irradiation, cutting/coring/chopping/slicing, canning, artificial ripening, cooking, pasteurizing/ho- mogenizing, 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 Commission on Small Farms farms generate less than $250,000 the FD&C Act, proposed § 112.3(b) recommended a definition for a small annual monetary value of all defines the terms ‘‘very small business’’ farm as a family farm with less than commodities sold, their revenue and ‘‘small business’’ for purposes of $250,000 annual monetary value of all constitutes only 41% of total gross this proposed rule only. FDA uses a commodities sold (Ref. 85). The revenue from all farms (Ref. 85). We measure of the average annual monetary Commission’s recommendation was propose to use the $250,000 annual value of food sold to determine farm based on the reasoning that these farms monetary value of food sold threshold size. This measure should serve as a are the likeliest to exit the industry, and for our cutoff of a very small farm since valid proxy for both the volume and have the greatest need to improve net the revenue of covered produce farms value of production within size category farm incomes Ref. 85). The Commission below this threshold constitutes only and commodities. The USDA National states that although 94% of all U.S. 12% of total gross revenue from food

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sales by produce farms and make up complying with specific proposed water is intended to, or is likely to, 83% of all produce farms. We propose provisions. contact covered produce or food-contact to use the statutory cutoff of $500,000 We propose to define ‘‘adequately surfaces, including water used in annual monetary value of food sold as reduce microorganisms of public health growing activities (including irrigation one part of the criteria for the qualified significance’’ to mean reduce the water applied using direct water exemption in section 419(f) of the FD&C presence of such microorganisms to an application methods, water used for Act (implemented in proposed § 112.5) extent sufficient to prevent illness. This preparing crop sprays, and water used as the threshold for a small farm. Farms proposed definition would establish in for growing sprouts) and in harvesting, below the $500,000 annual value of food part 112 a definition that we have used packing, and holding activities sold cutoff make up 89% of covered in guidance associated with the risk of (including water used for washing or farms, and their revenue constitutes foodborne illness from pathogens (Ref. cooling harvested produce and water 18% of total gross revenue from food 87. Ref. 88). As discussed in those used for preventing dehydration of sales by produce farms. We developed documents, the extent of reduction covered produce). This proposed this proposed definition using sales sufficient to prevent illness is usually definition is different from our class breaks found in generally available determined by the estimated extent to definition of agricultural water in our information from USDA (Ref. 86). which a pathogen may be present in the Good Agricultural Practices guide (Ref. Proposed § 112.3(b)(1) would define food combined with a safety factor to 10) both because it is not limited to your farm to be a very small business if account for uncertainty in that estimate. water in the growing environment, and it is subject to proposed part 112 and, For example, if it is estimated that there because we have excluded water that on a rolling basis, the average annual would be no more than 1,000 (i.e., 3 does not contact covered produce from monetary value of food you sold during logs) Salmonella organisms per gram of this definition based on the information the previous three-year period is no food, and a safety factor of 100 (i.e., 2 in our QAR. more than $250,000. logs) is employed, a process that We propose to define ‘‘animal Proposed § 112.3(b)(2) would define adequately reduces Salmonella spp. excreta’’ to mean solid or liquid animal your farm to be a small business if it is would be a process capable of reducing waste. By contrast, we are proposing to subject to proposed part 112 and, on a Salmonella spp. by 5 logs per gram of define ‘‘manure’’ to mean animal rolling basis, the average annual food. excreta, alone or in combination with monetary value of food you sold during We propose to define ‘‘agricultural litter (such as straw and feathers used the previous three-year period is no tea’’ to mean a water extract of for animal bedding) for use as a soil more than $500,000; and your farm is biological materials (such as humus, amendment. We are proposing not a very small business as provided in manure, non-fecal animal byproducts, definitions to distinguish ‘‘animal proposed § 112.3(b)(1). peat moss, pre-consumer vegetative excreta’’ from ‘‘manure’’ based on For clarity, in both proposed waste, table waste, or yard trimmings), whether the animal excreta is used as a § 112.3(b)(1) and (2), the limitation ‘‘if it excluding any form of human waste, soil amendment because some proposed is subject to this part’’ is intended to produced to transfer microbial biomass, requirements make such a distinction. exclude farms not subject to the fine particulate organic matter, and For example, the proposed requirements proposed rule per proposed § 112.4(a), soluble chemical components into an in §§ 112.54 and 112.56 are directed to that is, farms with $25,000 or less of aqueous phase. Agricultural teas are the treatment and safe application of annual value of food sold. As discussed held for longer than one hour before biological soil amendments of animal in section V.A.2.c of this document, we application. We developed this term to origin, including manure intentionally propose to exclude such farms from the cover a wide range of ‘‘teas’’ used in used as a soil amendment, and the coverage of this proposed rule such that production of fresh produce, but not to proposed requirements in §§ 112.82 and there would be no reason for them to be include ‘‘tea’’ served as a beverage. The 112.83 would be directed to preventing classified as small or very small term ‘‘agricultural tea’’ was based in contamination of covered produce with businesses. part on the definition of ‘‘compost tea’’ animal excreta deposited by wild or developed by the National Organic domestic animals that intrude in an area iii. Additional Proposed Definitions Standards Board (Ref. 89). Human waste where a covered activity is conducted Proposed § 112.3(c) would establish would be excluded for consistency with on covered produce. The proposed the following additional definitions that proposed § 112.53 regarding the use of definition of ‘‘manure’’ also accounts for would apply for the purposes of part human waste as a soil amendment. The the potential inclusion of animal litter 112. one hour limitation is intended to that is collected with animal excreta, We propose to define ‘‘adequate’’ to distinguish between agricultural teas e.g., from barns. mean that which is needed to and other liquids such as leachate and We propose to define ‘‘application accomplish the intended purpose in runoff and is consistent with the interval’’ to mean the time interval keeping with good public health recommendations of the between application of an agricultural practice. This proposed definition is the recommendations of the National input (such as a biological soil same as the definition we have Organic Standards Board (Ref. 36). amendment of animal origin) to a established in § 110.3 with respect to We propose to define ‘‘agricultural tea growing area and harvest of covered current good manufacturing practice in additive’’ to mean a nutrient source produce from the growing area where manufacturing, packing, or holding (such as molasses, yeast extract, or algal the agricultural input was applied. The human food. We have been applying powder) added to agricultural tea to proposed definition would provide a this definition for the purpose of increase microbial biomass. The term simple term to use when describing enforcing the regulations in part 110 for ‘‘agricultural tea additive’’ was based in such a time interval. The proposed more than 40 years and tentatively part on the definition of ‘‘compost tea application intervals for biological soil conclude that it would be an additive’’ developed by the National amendments in proposed § 112.56 appropriate definition to apply to part Organic Standards Board (Ref. 89). would establish requirements regarding 112 as well. Throughout this document, We propose to define ‘‘agricultural such time intervals. we provide examples of what we mean water’’ to mean water used in covered We propose to define ‘‘biological soil by ‘‘adequate’’ for purposes of activities on covered produce where amendment’’ to mean any soil

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amendment containing biological FD&C Act specifies that ‘‘[t]his section to, or is likely to, contact the harvestable materials such as humus, manure, non- shall not apply to produce that is part of the covered produce. fecal animal byproducts, peat moss, pre- produced by an individual for personal We propose to define ‘‘food’’ to mean consumer vegetative waste, sewage consumption,’’ and section 419(c)(1)(B) food as defined in section 201(f) of the sludge biosolids, table waste, of the FD&C Act also requires that FDA FD&C Act and to include seeds and agricultural tea, or yard trimmings, ensure that the final rule is practicable beans used to grow sprouts. We have alone or in combination. We are for ‘‘a small food processing facility co- long considered seeds and beans used to proposing this definition as a means to located on a farm.’’ grow sprouts to be ‘‘food’’ within the distinguish soil amendments that FDA tentatively concludes that on- meaning of section 201(f) of the FD&C contain biological components from farm manufacturing/processing Act (Ref. 95). Seeds and beans used to those that do not (like chemical activities for on-farm consumption (like grow sprouts are both articles used for fertilizers). In addition, we propose to produce for individual consumption) food and articles used for components define ‘‘biological soil amendment of should not be subject to this rule, either of articles used for food. We are animal origin’’ to mean a biological soil because it is automatically excluded by proposing to include them specifically amendment which consists, in whole or Section 419(g) or because, to the extent in the definition of food for purposes of in part, of materials of animal origin, there may be any difference between this rule for clarity because sprouts are such as manure or non-fecal animal produce ‘‘for personal consumption’’ covered by this rule. byproducts, or table waste, alone or in and produce ‘‘consumed on the farm or We propose to define ‘‘food-contact combination. The term ‘‘biological soil another farm under the same surfaces’’ to mean those surfaces that amendment of animal origin’’ does not ownership,’’ it is appropriate to exclude contact human food and those surfaces include any form of human waste. We on-farm manufacturing/processing for from which drainage or other transfer are proposing this definition as a means on-farm consumption from the rule. The onto the food or onto surfaces that to distinguish these biological soil definition of covered activity would also contact the food ordinarily occurs amendments from soil amendments that specify, for clarity, that this part does during the normal course of operations. are wholly plant-based (such as yard not apply to activities of a facility that ‘‘Food-contact surfaces’’ includes food- trimmings). are subject to part 110 of this chapter . contact surfaces of equipment and tools We propose to define ‘‘composting’’ to We propose to define ‘‘covered used during harvest, packing, and mean a process to produce humus in produce’’ to mean produce that is holding. This proposed definition of which organic material is decomposed subject to the requirements of this part ‘‘food-contact surfaces’’ is consistent by the actions of microorganisms under in accordance with §§ 112.1 and 112.2. with the definition of this term in thermophilic conditions for a The term ‘‘covered produce’’ refers to § 110.3 except that we propose to add designated period of time (for example, the harvestable or harvested part of the the phrase ‘‘or other transfer’’ after 3 days) at a designated temperature (for crop. We are proposing to define ‘‘drainage’’ definition of ‘‘food-contact example, 131 °F (55 °C)), followed by a ‘‘covered produce’’ to provide a simple surfaces’’ to clarify that surfaces from curing stage under cooler conditions. term to use when describing food that which any transfer involving liquids or The proposed definition is consistent would be within the scope of the rule non-liquids onto the food or onto with definitions or explanations of under proposed § 112.1 and not exempt surfaces that contact the food are food- ‘‘compost’’ and ‘‘composting’’ in from the rule under proposed § 112.2. contact surfaces. documents such as a State regulation We propose to define ‘‘curing’’ to We propose to define ‘‘hazard’’ to (Ref. 90), Appendix B to 40 CFR part mean the maturation stage of mean any biological agent that is 503 (Ref. 91), documents prepared by composting, which is conducted after reasonably likely to cause illness or the U.S. EPA (Ref. 92), and the Produce much of the readily metabolized injury in the absence of its control. The Safety Project Issue Brief on Composting biological material has been proposed definition is consistent with of Animal Manures (Ref. 27). decomposed, at cooler temperatures the NACMCF HACCP guidelines, the We propose to define ‘‘covered than those in the thermophilic phase of Codex HACCP Annex, Federal HACCP activity’’ to mean growing, harvesting, composting, to further reduce regulations for seafood, juice, and meat packing, or holding covered produce, pathogens, promote further and poultry, except that for the provided that all covered produce used decomposition of cellulose and lignin, purposes of this rule the term would be in covered packing or holding activities and stabilize composition. This limited to biological hazards because, as is grown, raised, or consumed on that proposed definition is consistent with discussed in section IV.A. of this farm or another farm under the same definitions of ‘‘curing’’ in a State document, this proposed rule is only ownership. Covered activities would not regulation (Ref. 93), documents addressing biological hazards. The include manufacturing/processing prepared by the U.S. EPA (Ref. 92), and NACMCF HACCP guidelines (Ref. 41) within the definition elsewhere in a glossary of composting terms prepared and our HACCP regulation for juice proposed § 112.3(c). As discussed in by the Cornell Waste Management (§ 120.3(g)) define ‘‘hazard’’ and ‘‘food sections III.F and V.A.2.b.i of this Institute (Ref. 94). hazard,’’ respectively as a biological, document, manufacturing/processing on We propose to define ‘‘direct water chemical, or physical agent that is a farm is potentially subject to the application method’’ to mean using reasonably likely to cause illness or coverage of Section 418 of the FD&C agricultural water in a manner whereby injury in the absence of its control. The Act, unless all of the food used in such the water is intended to, or is likely to, Codex HACCP Annex defines ‘‘hazard’’ activities is consumed on that farm or contact covered produce or food-contact as a biological, chemical or physical another farm under the same ownership. surfaces during use of the water. This agent in, or condition of, food with the Where all of the manufactured/ proposed definition would provide a potential to cause an adverse health processed food is consumed on that simple term to use when describing effect (Ref. 96). Our HACCP regulation farm or another farm under the same such water within regulations such as for seafood (§ 123.3(f)) and the FSIS ownership, the activity would be proposed § 112.44(c). By cross-reference HACCP regulation for meat and poultry potentially within the scope of Section to the definitions of ‘‘covered produce’’ (9 CFR 417.1) define ‘‘food safety 419 of the FD&C Act and this proposed and ‘‘produce’’, this term only applies to hazard’’ as any biological, chemical, or rule, except that Section 419(g) of the methods in which the water is intended physical property that may cause a food

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to be unsafe for human consumption. microscopic parasites (e.g., Cyclospora this rule, we propose to define ‘‘fruit’’ We recognize that there are other cayetanensis). Because such as the edible reproductive body of a hazards relevant to produce safety on microorganisms are relevant to produce seed plant or tree nut (such as apple, farm that would not be addressed in this safety, we tentatively conclude that it is orange and almond) such that fruit proposed rule such as chemical, reasonable to include them. means the harvestable or harvested part physical, and radiological hazards (see We propose to define ‘‘monitor’’ to of a plant developed from a flower; and section IV.B. of this document) and do mean to conduct a planned sequence of ‘‘vegetable’’ as the edible part of an not intend to suggest by this definition observations or measurements to assess herbaceous plant (such as cabbage or that such hazards are not hazards. We whether a process, point, or procedure potato) or fleshy fruiting body of a request comment on whether we should is under control, and, when applicable, fungus (such as white button or instead use the term ‘‘biological to produce an accurate record of the shiitake) grown for an edible part such hazards’’ in this rule. observation or measurement. that vegetable means the harvestable or We propose to define ‘‘humus’’ to We propose to define ‘‘non-fecal harvested part of any plant or fungus mean a stabilized (i.e., finished) animal byproduct’’ to mean solid waste whose fruit, fleshy fruiting bodies, biological soil amendment produced (other than manure) that is animal in seeds, roots, tubers, bulbs, stems, leaves, through a controlled composting origin (such as meat, fat, dairy products, or flower parts are used as food and process. We are proposing to use eggs, carcasses, blood meal, bone meal, includes mushrooms, sprouts, and herbs ‘‘humus’’ as the term to identify the fish meal, shellfish waste (such as crab, (such as basil or cilantro). final, mature product of composting for shrimp, and lobster waste), fish For the purposes of this rule, produce the purpose of this rule. Our proposed emulsions, and offal) and is generated does not include ‘‘food grains’’ meaning definition derives from our proposed by commercial, institutional, or the small, hard fruits or seeds of arable definitions for ‘‘composting’’ and agricultural operations. This proposed crops, or the crops bearing these fruits ‘‘curing’’ and the Cornell Waste definition reflects the use of a similar or seeds, that are grown and processed Management Institute’s glossary of term in sources such as the State of for use as meal, flour, baked goods, composting terms (Ref. 94), which Florida’s regulations (Ref. 90). However, cereals and oils rather than for fresh defines humus as a complex aggregate we are proposing to include more consumption (including cereal grains, made during the decomposition of plant examples of these byproducts than are pseudo cereals, oilseeds and other and animal residues; mainly derivatives included in Florida’s regulations to plants used in the same fashion). of lignin, proteins, and cellulose clearly communicate what we mean by Examples of food grains include barley, combined with inorganic soil parts. the term. We propose to define ‘‘pest’’ dent- or flint-corn, sorghum, oats, rice, However, other relevant documents to mean any objectionable animals or rye, wheat, amaranth, quinoa, (Ref. 27. Ref. 92. Ref. 97) refer to the insects including birds, rodents, flies, buckwheat, cotton seed, and soybeans. production of ‘‘humus-like material’’ and larvae. This proposed definition is With this definition, we are proposing through composting, and humus can be consistent with the definition of ‘‘pest’’ to specifically include mushrooms, produced by mechanisms other than the in current § 110.3. sprouts (irrespective of seed source), action of microorganisms (Ref. 98). We We propose to define ‘‘pre-consumer peanuts, tree nuts and herbs, and request comment on whether our vegetative waste’’ to mean solid waste specifically exclude food grains. We proposed definition and use of the term that is purely vegetative in origin, not explain our proposed definition of ‘‘humus’’ for the final product of considered yard trash, and derived from ‘‘produce’’ in detail above, in section composting is appropriate for the commercial, institutional, or V.A.2.a of this document. We request purpose of this rule, or whether we agricultural operations without coming comments on our proposed definition of should use a term other than ‘‘humus,’’ in contact with animal products, ‘‘produce.’’ such as ‘‘mature compost.’’ byproducts or manure or with an end We propose to define ‘‘production We propose to define ‘‘manure’’ to user (consumer). As proposed, pre- batch of sprouts’’ to mean all sprouts mean animal excreta, alone or in consumer vegetative waste includes that are started at the same time in a combination with litter (such as straw material generated by farms, packing single growing unit (e.g., a single drum and feathers used for animal bedding) houses, canning operations, wholesale or bin, or a single rack of trays that are for use as a soil amendment. As distribution centers and grocery stores; connected to each other), whether or not discussed above in the definition of products that have been removed from the sprouts are grown from a single lot animal excreta, this definition is their packaging (such as out-of-date of seed (including, for example, when intended to make a distinction between juice, vegetables, condiments, and multiple types of seeds are grown the terms ‘‘manure’’ and ‘‘animal bread); and associated packaging that is within a single growing unit). Through excreta.’’ vegetative in origin (such as paper or this definition, we intend to treat as a We propose to define corn-starch based products). As production batch product that would be ‘‘microorganisms’’ to mean yeasts, proposed, pre-consumer vegetative exposed to the same conditions during molds, bacteria, viruses, protozoa, and waste does not include table waste, sprouting, such as multiple seed types microscopic parasites and to include packaging that has come in contact with grown in a common drum or multiple species having public health materials (such as meat) that are not trays in a single rack that may be significance. As proposed, the term vegetative in origin, or any waste exposed to water that has contacted ‘‘undesirable microorganisms’’ includes generated by restaurants. This proposed other product in the same growing unit. those microorganisms that are of public definition is consistent with a State This term is used in proposed subpart health significance, that subject food to regulation (Ref. 90). M. Limiting the definition of decomposition, that indicate that food is For the purpose of this rule, we ‘‘production lot’’ to a single growing contaminated with filth, or that propose to define the term ‘‘produce’’ to unit would prevent sprout growers from otherwise may cause food to be mean any fruit or vegetable (including ‘‘pooling’’ samples from multiple adulterated. The substantive difference mixes of intact fruits and vegetables) growing units within an operation between this proposed definition and and includes mushrooms, sprouts whereby contamination in spent water that in current § 110.3 is the addition of (irrespective of seed source), peanuts, in one unit could be diluted by non- protozoa (e.g., Giardia lamblia) and tree nuts and herbs. For the purposes of contaminated water from other units to

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the point where pathogens might not be this rule. We recognize that there are the term, it provides convenience since detected. This proposed definition is other reasonably foreseeable hazards it is addressing the identical standards consistent with our 1999 guidance for relevant to produce safety on farm that that we are proposing for identical industry on sampling and microbial would not be addressed in this hazards that exist for such growth media testing of spent irrigation water during proposed rule such as chemical, and soil amendments. sprout production (Ref. 15). We physical, and radiological hazards (see We propose to define ‘‘spent sprout recognize that there are a diversity of section IV.B of this document) and do irrigation water’’ to mean water that has growing practices and a variety of not intend to suggest by this definition been used in the growing of sprouts. growing units that may represent that such hazards are not reasonably This definition is intended to minimize different product volumes, so we foreseeable. We request comment on the potential for confusion between request comment on this proposed whether we should instead use the term spent sprout irrigation water and water definition. ‘‘reasonably foreseeable biological used for irrigation of other types of We propose to define ‘‘qualified end- hazards’’ in this rule. covered produce.We are proposing to user,’’ with respect to a food, to mean We propose to define ‘‘sanitize’’ to define ‘‘static composting’’ to mean a the consumer of the food; or a restaurant mean to adequately treat cleaned food- process to produce humus in which air or retail food establishment (as those contact surfaces by a process that is is introduced into biological material (in terms are defined in § 1.227) that is effective in destroying vegetative cells of a pile (or row) covered with at least 6 located (i) in the same State as the farm microorganisms of public health inches of insulating material, or in an that produced the food; or (ii) not more significance, and in substantially enclosed vessel) by a mechanism that than 275 miles from such farm. The reducing numbers of other undesirable does not include turning. As proposed, definition would also state that the term microorganisms, but without adversely examples of structural features for ‘‘consumer’’ does not include a affecting the product or its safety for the introducing air would include business. This definition implements consumer. This proposed definition is embedded perforated pipes and a section 419(f)(4) of the FD&C Act. We consistent with the existing § 110.3 constructed permanent base that note that section 419(f)(4)(A) of the definition for ‘‘sanitize’’ except that we includes aeration slots. As proposed, FD&C Act does not provide for a propose to include the term ‘‘cleaned’’ examples of mechanisms for different analysis for when an before ‘‘food-contact surfaces.’’ It is well introducing air include passive international border falls within the 275 established that sanitizers can be diffusion and mechanical means (such miles; thus, we tentatively conclude that inactivated by organic material and, as blowers that suction air from the international borders should not affect thus, are not effective unless used on composting material or blow air into the the distance calculation. Thus, for clean surfaces (Ref. 99). This proposed composting material using positive example, a farm in Mexico selling food definition is consistent with the pressure). The proposed definition to a restaurant or retail food definition of ‘‘sanitize’’ in § 111.3. derives from definitions and establishment in the U.S. that is within We propose to define ‘‘sewage sludge explanations of ‘‘static composting’’ in 275 miles of the farm could count that biosolids’’ to mean the solid or semi- documents such as prepared by the U.S. sale as a sale to a qualified end user. As solid residue generated during the EPA (Ref. 92), the Produce Safety another example, the same would also treatment of domestic sewage in a Project Issue Brief on Composting of be true for a U.S. farm selling food to a treatment works within the meaning of Animal Manures (Ref. 27), and a report restaurant or retail food establishment the definition of ‘sewage sludge’ in 40 from the Food and Agriculture in Mexico that is within 275 miles of the CFR 503.9(w). This proposed definition Organization of the United Nations (Ref. farm. Finally, we also note that the is consistent with that of the U.S. 100). requirements related to distance (in the Environmental Protection Agency We propose to define ‘‘surface water’’ same state or within 275 miles of the (EPA), which has regulatory jurisdiction to mean all water which is open to the farm) only apply to restaurants and over treated domestic sewage and has atmosphere and subject to surface retail food establishment customers, and established terms to describe specific runoff, including water obtained from not to consumers. Thus, a farm may types of treated waste. an underground aquifer that is held or count any sale directly to a consumer as We propose to define ‘‘soil conveyed in a manner that is open to a sale to a qualified end-user. amendment’’ to mean any chemical, the atmosphere, such as in canals, We propose to define ‘‘raw biological, or physical material (such as ponds, other surface containment or agricultural commodity (RAC)’’ to mean elemental fertilizers, humus, manure, open conveyances. This proposed ‘‘raw agricultural commodity’’ as non-fecal animal byproducts, peat moss, definition is consistent with EPA’s defined in section 201(r) of the FD&C perlite, pre-consumer vegetative waste, definition and with common usage of Act. We propose to include this sewage sludge biosolids, table waste, the term ‘‘surface water’’ (Ref. 101). We reference to the FD&C Act definition to agricultural tea and yard trimmings) propose to define this term to provide additional clarity regarding the intentionally added to the soil to distinguish ‘‘surface water’’ from other meaning of this term. improve the chemical or physical water, such as water from an We propose to define ‘‘reasonably condition of soil in relation to plant underground aquifer that has not been foreseeable hazard’’ to mean a potential growth or to improve the capacity of the held or conveyed in a manner open to hazard that may be associated with the soil to hold water. This proposed the environment (‘‘ground water’’) farm or the food. We provide a proposed definition is consistent with commonly because there is a greater likelihood that definition for this term as it is used in used definitions in industry guidelines surface water could become section 419(c)(1)(A) of the FD&C Act and marketing agreements (Ref. 46. Ref. contaminated, for example, by surface and reflected in several requirements 31). We also propose to include within runoff. proposed in this rule. As noted in the the meaning of ‘‘soil amendment’’ We propose to define ‘‘table waste’’ to discussion of the proposed definition of growth media that serve as the entire mean any post-consumer food waste, ‘‘hazard’’ in this section, this definition substrate during the growth of covered irrespective of whether the source would be limited to biological hazards produce (such as mushrooms and some material is animal or vegetative in because those are the only hazards we sprouts). While this inclusion is not origin, derived from individuals, are currently proposing to address in consistent with the common usage of institutions, restaurants, retail

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operations, or other sources where the We propose to define ‘‘you’’ to mean farm under the same ownership, or for food has been served to a consumer. a person who is subject to some or all personal consumption), this would not This definition is intended to of the requirements in this part. be a ‘‘covered activity’’ as that term is distinguish post-consumer food waste defined in proposed § 112.3(c) and c. Persons Subject to This Rule from pre-consumer vegetative waste. would therefore not be subject to this We propose to define ‘‘turned Proposed § 112.4(a) states that, except rule. In proposed § 112.4(b), we propose composting’’ to mean a process to as provided in paragraph (b) of that to state that you are not a covered farm produce humus in which air is section, if you are a farm or farm mixed- if you satisfy the requirements in § 112.5 introduced into biological material (in a type facility with an average annual and we have not withdrawn your pile, row, or enclosed vessel) by turning monetary value of food (as ‘‘food’’ is exemption in accordance with the on a regular basis. Turning is the defined in § 112.3(c)) sold during the requirements of subpart R of this part. process of mechanically mixing previous three-year period of more than This implements section 419(f) of the biological material that is undergoing a $25,000 (on a rolling basis), you are a FD&C Act and is discussed further composting process with the specific ‘‘covered farm’’ subject to this part; immediately below. intention of moving the outer, cooler however, specific exemptions and sections of the material being partial exemptions apply. If you are a d. Qualified Exemptions composted to the inner, hotter sections. covered farm subject to this part, you i. Criteria for Eligibility for a Qualified The proposed definition is consistent must comply with all applicable Exemption with definitions or explanations of requirements of this part when you Proposed § 112.5(a) establishes the ‘‘windrow composting’’ in documents conduct a covered activity on covered criteria for eligibility for a qualified prepared by the U.S. EPA (Ref. 92. Ref. produce. We are proposing to apply this 91), the Produce Safety Project Issue proposed rule only to farms and farm exemption and associated special Brief on Composting of Animal Manures mixed-type facilities with an average requirements based on average (Ref. 27), and a report from the Food annual monetary value of food (as monetary value of all food sold and and Agriculture Organization of the ‘‘food’’ is defined in § 112.3(c)) sold direct farm marketing. This exemption United Nations (Ref. 100). We are during the previous three-year period of is mandated by Section 419(f) of the proposing to use the term ‘‘turned more than $25,000 (on a rolling basis) FD&C Act. Except as provided in composting’’ rather than ‘‘windrow because we have tentatively concluded § 112.6, you would be exempt from all composting’’ so that the term describing that farms with $25,000 or less in sales of the requirements of this part, except this method would not be limited to use do not contribute significantly to the proposed subparts except A, Q, and R, produce market. Farms below the in a calendar year if: in ‘‘rows.’’ • We propose to define ‘‘water $25,000 limit collectively account for During the previous 3-year period distribution system’’ to mean a system only 1.5% of covered produce acres, preceding the applicable calendar year, to carry water from its primary source suggesting that they contribute little the average annual monetary value of to its point of use, including pipes, exposure to the overall produce the food you sold directly to qualified sprinklers, irrigation canals, pumps, consumption. We note that such farms end-users during such period exceeded valves, storage tanks, reservoirs, meters, are and will continue to be covered the average annual monetary value of and fittings. The proposed definition under the adulteration provisions and the food you sold to all other buyers would provide a simple term to use other applicable provisions of the during that period (§ 112.5(a)(1)); and • when describing such systems. Federal Food, Drug, and Cosmetic Act The average annual monetary value We propose to define ‘‘we’’ to mean and applicable implementing of all food you sold during the 3-year the U.S. Food and Drug Administration. regulations, irrespective of whether they period preceding the applicable We propose to define ‘‘yard are included within the scope of this calendar year was less than $500,000, trimmings’’ to mean purely vegetative proposed rule. adjusted for inflation (§ 112.5(a)(2)). matter resulting from landscaping As proposed, § 112.4(a) would make Proposed § 112.5(b) provides that, for maintenance or land clearing clear that the rule applies to both farms the purpose of determining whether the operations, including materials such as and farm mixed-type facilities, and that average annual monetary value of all tree and shrub trimmings, grass such entities would be subject to the food sold during the 3-year period clippings, palm fronds, trees, tree rule when they conduct a covered preceding the applicable calendar year stumps, untreated lumber, untreated activity on covered produce, as those was less than $500,000, adjusted for wooden pallets, and associated rocks terms are defined in proposed inflation, the baseline year for and soils. This proposed definition is § 112.3(c). This would mean that, for calculating the adjustment for inflation consistent with a definition in State example, a farm mixed-type facility that is 2011. The conditions related to composting regulations (Ref. 90), except is a covered farm and that grows, average annual monetary value that we are proposing to use the term harvests, packs, and holds its own established in section 419(f)(1)(B) of the ‘‘yard trimmings’’ rather than ‘‘yard lettuce would be subject to the proposed FD&C Act allow adjustment for trash.’’ We are proposing to use the term rule when conducting those activities inflation. To establish a level playing ‘‘yard trimmings’’ to avoid potentially (unless an exemption applies, such as field for all farms that may satisfy the negative connotations associated with that in proposed § 112.4(b)). However, criteria for the qualified exemption, we the word ‘‘trash,’’ even though some the covered farm would not be subject are proposing to establish the baseline components of our proposed definition to the rule when conducting other year for the calculation in proposed (e.g., untreated wooden pallets) arguably activities that are not covered activities, § 112.5(a)(2). We are proposing to are not ‘‘trimmings.’’ We request or when conducting operations on food establish 2011 as the baseline year for comment on whether our proposed use other than covered produce. For inflation because 2011 is the year that of the term ‘‘yard trimmings’’ is example, if the farm mixed-type facility FSMA was enacted into law. appropriate for the purpose of this rule, applied a manufacturing/processing Section 419(f) of the FD&C Act does or whether we should propose to use a step (such as chopping) to its lettuce for not specifically target arrangements term other than ‘‘yard trimmings,’’ such distribution into commerce (i.e., not for such as community-sponsored as ‘‘yard trash’’ or ‘‘yard waste.’’ consumption on the farm or another agriculture (CSA), you-pick operations,

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or farmers markets. It does seem likely Specifically, proposed § 112.6(b)(1) the produce) irrespective of whether the that many such operations will meet the would require that, when a food produce bears a label. The use of the criteria for qualified exemption. Each packaging label is required on food that term ‘‘business address’’ in section such operation would need to analyze would otherwise be covered produce 419(f)(2)(A) of the FD&C Act contrasts its sales under the terms of § 112.5 to under the FD&C Act or its implementing with Congress’ use of a different term, determine its eligibility for the qualified regulations, you include prominently ‘‘place of business,’’ in section 403(e) of exemption. For example, if a you-pick and conspicuously on the food the FD&C Act (21 U.S.C. 343(e)). Section operation has an average annual packaging label the name and complete 403(e) provides that foods in package monetary value of food sold during the business address of the farm where the form are misbranded unless the product relevant 3-year period of less than produce was grown. Proposed label bears the name and place of $500,000, and all of its sales were to § 112.6(b)(2) requires that, when a food business of the manufacturer, packer, or individuals who come to the farm to packaging label is not required on food distributor of the food. Our regulations pick their own produce, all of its sales that would otherwise be covered interpret ‘‘place of business’’ as would be sales to consumers (who are produce under the FD&C Act, you requiring only the firm’s city, state, and qualified end-users, regardless of prominently and conspicuously display, zip code to appear on the product label, location) for the purpose of determining at the point of purchase, the name and as long as the firm’s street address is the proportion of the sales that are to complete business address of the farm listed in a current telephone directory or qualified end-users. In this example, the where the produce was grown. As other city directory (21 CFR 101.5(d)). you-pick farm would be eligible for the proposed, the name and address of the We tentatively conclude that the use of qualified exemption. As another farm must be displayed on a label, the term ‘‘business address’’ in section example, if a CSA farm has an average poster, sign, placard, or documents 419(f)(2)(A) demonstrates Congress’ annual monetary value of food sold delivered contemporaneously with the intent to require the farm’s full address, during the relevant 3-year period of less produce in the normal course of including the street address or P.O. box, than $500,000; and 25% of the monetary business, or, in the case of Internet to appear on labels or other required value of its sales comes from sales to sales, in an electronic notice. That is, if notifications when the farm qualifies for individual consumers enrolled in the a label is otherwise required on the the exemption in section 419(f) of the CSA, 50% of the monetary value of its produce that would otherwise be FD&C Act. If Congress had considered sales comes from sales to restaurants in covered (for example, tomatoes in a the less complete address already the same state as the farm, and 25% of ‘‘clam shell’’ package) then the label required under section 403(e)(1) of the the monetary value of its sales comes must include the name and business FD&C Act and the ‘‘place of business’’ from sales to other buyers who are not address of the farm where the produce labeling regulation (§ 101.5(d)) to be qualified end-users; the CSA farm was grown. If a label is not required (for adequate for notification to consumers would be eligible for the qualified example, unpackaged tomatoes) then for foods required to bear labels, there exemption. In this example, the CSA the name and business address of the would have been no need to impose a farm’s sales to qualified end-users farm where the produce was grown new, more specific requirement in (consumers and in-state restaurants) must be displayed at the point of section 419(f)(2)(A)(1) for the farm’s make up 75% of the average annual purchase (such as on a poster, for ‘‘business address’’ to appear on the monetary value of food sold, so the example). These proposed provisions food label. Requiring the complete value of the farm’s sales to qualified reflect our interpretation of section business address for this purpose is end-users exceed the value of its sales 419(f)(2)(A)(i) and (ii) as applying only consistent with our guidance to industry to all other buyers during the relevant to food that would otherwise be covered on the labeling of dietary supplements time period. produce but for the qualified exemption. as required by the Dietary Supplement We tentatively conclude that this and Nonprescription Drug Consumer ii. Applicable Requirements for interpretation is reasonable because Protection Act (Ref. 103). When Qualified Exemptions applying these consumer notification proposed § 112.5(b) would apply to a Proposed § 112.6 establishes the requirements to food that would not food for which a food packaging label is requirements that apply to you if you otherwise be covered produce would required under any other provision of are eligible for a qualified exemption in mean applying requirements to food the FD&C Act, the complete business accordance with § 112.5. Proposed that bears no relationship to the subject address would substitute for the ‘‘place § 112.6(a) explains that subparts A, Q, of this rulemaking (e.g., to milk from a of business’’ required under section and R remain applicable to those who farm that also grows and harvests 403(e)(1) of the FD&C Act and 21 CFR qualify for a qualified exemption under produce and that meets the criteria for 101.5(d) and would not impose any § 112.5. This is because subpart A the qualified exemption from this requirement for a label that would be in contains this provision and other proposed rule). addition to any label required under any general provisions such as definitions, Proposed 112.6(b)(3) states that the other provision of the FD&C Act. We Subpart Q contains provisions related to complete business address that you seek comment on the feasibility of the compliance and enforcement, and must include in accordance with the labeling provisions in proposed subpart R contains provisions necessary requirements of paragraph (b)(1) or (2) 112.6(b), particularly in the case of to implement section 419(f)(3) of the of this section must include the street consolidating produce from several farm FD&C Act, as discussed further in address or post office box, city, state, locations. section V.R. of this document. and zip code for domestic farms, and Section 419 of the FD&C Act does not Consistent with section 419(f)(2) of the comparable full address information for explicitly require farms that meet the FD&C Act, proposed § 112.6(b) foreign farms. Proposed § 112.6(b)(3) criteria for the qualified exemption to establishes the modified requirements would enable consumers to contact the establish and maintain documentation (label or point of purchase display) farm where the food that would of the basis for their exemption. FDA applicable to those who meet the otherwise be covered produce was considers that it may be necessary for requirements under § 112.5 for a grown (e.g., if the consumer identifies or farms to maintain such records, and to qualified exemption. suspects a food safety problem with a allow FDA access to such records upon

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request, in order to efficiently enforce expeditiously accommodate new protection as the requirements of this section 419 of the FD&C Act. Otherwise scientific knowledge. part (see section V.P. of this document). we would have no way to determine Section 402 of the FD&C Act specifies We also intend to publish guidance, as whether a farm claiming the qualified conditions under which a food is appropriate, to provide updates on exemption actually met the criteria for deemed adulterated, including if the current thinking with respect to best that exemption. This could be food bears or contains any added practices in produce safety. important, for example, if a farm poisonous or deleterious substance 2. Proposed Requirements claiming the qualified exemption is which may render it injurious to health directly linked to a foodborne illness (402(a)(1)); if it is unfit for food a. General Requirements Applicable to outbreak during an active investigation (402(a)(3)); or if it has been prepared, Persons Subject to This Part or if FDA determines, based on conduct packed, or held under insanitary As proposed, § 112.11 establishes the or conditions associated with the farm conditions whereby it may have become general requirements applicable to contaminated with filth, or whereby it that are material to the safety of the food persons who are subject to this rule. may have been rendered injurious to produced or harvested at such farm, that Proposed § 112.11 requires that you take health (402(a)(4)). In proposed § 112.11, it is necessary to protect the public appropriate measures to minimize the we would specifically require that health and prevent or mitigate a risk of serious adverse health covered farms take appropriate foodborne illness outbreak to withdraw consequences or death from the use of, measures to minimize the risk of serious the farm’s qualified exemption (see or exposure to, covered produce, adverse health consequences or death section V.R. of this document discussing including those measures reasonably from the use of, or exposure to, covered proposed subpart R). Because the necessary to prevent the introduction of produce, including those measures withdrawal procedure in proposed known or reasonably foreseeable subpart R would only apply to farms reasonably necessary to prevent the introduction of known or reasonably hazards into covered produce, and to that are eligible for the qualified provide reasonable assurances that the exemption, we would need to know foreseeable hazards into covered produce as well as to provide reasonable produce is not adulterated under section whether the farm is indeed eligible for 402 of the FD&C Act on account of such the exemption in order to select the assurances that the produce is not adulterated under section 402 of the hazards. appropriate and efficient enforcement This provision is consistent with the strategy. We request comment on FD&C Act on account of such hazards. Such hazards would include all requirements of section 419(c)(1)(a) of whether we should require farms to be the FD&C Act, which mandates, in able to provide adequate pathogens to the extent that they pose a risk of serious adverse health relevant part, that we publish documentation, as needed, to regulations that ‘‘set forth those demonstrate the basis for the qualified consequences or death, including Salmonella and E. coli O157:H7, in all procedures, processes, and practices exemption. Specifically, we request that the Secretary determines to comment on whether we should do this covered produce raw agricultural commodities, including leafy greens. minimize the risk of serious adverse by requiring records to be established health consequences or death, including and maintained in accordance with the With respect to bagged salads, we note that such salads are manufactured in procedures, processes, and practices requirements of proposed subpart O, or that the Secretary determines to be if there is an alternative strategy by facilities that are required to register with us and, therefore, would be reasonably necessary to prevent the which we could require retention of and covered under section 418 of the FD&C introduction of known or reasonably access to such records (such as by Act and any regulations promulgated foreseeable biological, chemical, and requiring farms only to retain records pursuant to that authority, rather than physical hazards, including hazards that kept in the normal course of their by this proposed rulemaking. occur naturally, may be unintentionally business bearing on the criteria for the We recognize the value in making this introduced, * * * into fruits and qualified exemption that they use to regulation flexible, where appropriate, vegetables, * * * and to provide determine their eligibility and requiring to accommodate future changes in reasonable assurances that the produce FDA access to such records upon science and technology. In proposed is not adulterated under section 402.’’ request). § 112.12, we list the specific As discussed in section IV.B. of this B. Subpart B—General Requirements requirements established in this rule for document, we have tentatively which we believe alternatives may be concluded that this rule should focus As proposed, subpart B discusses the appropriate and the circumstances solely on biological hazards. general requirements applicable to under which such alternatives could be In subparts C to O, we propose persons who are subject to this part and used. In addition, consistent with science-based minimum standards alternatives from the requirements section 419(c)(2) of the FD&C Act, in related to the growing, harvesting, established in this part that would be proposed subpart P, we provide for a packing, and holding of covered permitted, under specified conditions. mechanism by which a State or a foreign produce that we believe are necessary to 1. Comments Relevant to Proposed country from which food is imported minimize the risk of serious adverse Provisions into the United States may request a health consequences or death by variance from one or more requirements preventing the introduction of hazards We received several comments in proposed in this part, where the State or and providing reasonable assurances response to the 2010 FR notice that foreign country determines that: (a) The that the covered produce is not addressed issues relevant to the general variance is necessary in light of local adulterated. requirements established in this subpart growing conditions; and (b) the Proposed § 112.11 would require, for of the rule. A consumer organization procedures, processes, and practices to example, that whenever a standard urged FDA to take additional steps to be followed under the variance are specified in this part is not met, you ensure the safety of bagged salads and reasonably likely to ensure that the would take those steps reasonably all leafy greens. Some comments produce is not adulterated under necessary to identify and evaluate the recommended that FDA include in this Section 402 of the Act and to provide cause of the problem and ensure that it rule an amendment mechanism that can the same level of public health is rectified. Accurate identification of

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the cause of the failure is critical to the areas, to clear farm borders around accordance with the requirements of success of any potential corrective outdoor growing areas or drainages, or subpart O of this part. As discussed in actions. For example, if your employees to take any action that would violate section II.E.4. of this document, FDA is are having difficulty identifying covered applicable environmental laws or collaborating with partners on research produce that should not be harvested regulations. that may provide scientific support for due to potential contamination, you We propose to include proposed specific alternatives to certain of these might initially think the answer is to § 112.11 in order to account for the requirements. FDA intends to issue provide more frequent training; however variety of possible circumstances that guidance on specific alternatives that it upon investigation, you may discover might arise in which an unexpected may identify as meeting the that the actual cause of the problem is circumstance or unique farm requirements of the rule in order to that your employee training program is characteristics would justify preventive assist farms in complying with the final providing inaccurate information. In measures to prevent introduction of rule. For example, a farm that applies this case, to correct the problem, you hazards or provide assurances against crop protection sprays to the harvestable would need to fix your training adulteration in order to minimize the portion of crops (i.e., application of program. Promptly taking such follow- risk of serious adverse health water containing crop protection up actions once the cause of the consequences or death. We request substances using a direct water problem has been identified is necessary comment on this approach, and on application method) several days before to minimize the risk of serious adverse whether we should instead establish the crop is harvested using a water health consequences or death from the specific standards for any types of source that does not meet the use of, or exposure to, your covered hazards that would be covered in requirements of § 112.44(c) (i.e, EPA produce and to provide reasonable proposed § 112.11 but for which we generic E. coli ‘‘recreational water’’ assurances that the product is not have not proposed specific standards in standard), may use an alternative adulterated under section 402 of the proposed subparts C through O. measure provided by their Cooperative FD&C Act. b. Alternatives to Certain Requirements Extension agent, for example, as long as the measure is based on scientifically In addition, proposed § 112.11 would As proposed, § 112.12 allows for the sound data and meets the conditions require you to take appropriate use of alternatives to certain described above (i.e., provides the same measures to minimize risks of serious requirements of this part. Subparagraph level of public health protection as the adverse health consequences or death (a) lists the specific requirements for applicable requirement and does not from the use of, or exposure to, covered which alternatives may be considered increase the likelihood that covered produce that may arise unexpectedly provided you are in compliance with produce will be adulterated). For and therefore not be reflected in a subparagraphs (b) and (c), which specific standard set forth in proposed describe the conditions for use of an example, the study might demonstrate subparts C to O of this rule. For alternative. Proposed § 112.12(b) states that the quality of water used for direct example, in the event of an unexpected that you may establish and use an application method irrigation is not event, such as receipt of information alternative to any of the requirements important as long as there are at least suggesting that your covered produce listed in paragraph (a), provided you two days between application and from a particular field is adulterated have adequate scientific data or harvest, or that water of some lesser because it bears or contains a pathogen information to support a conclusion that standard than that in § 112.44(c) could that may render the produce injurious to the alternative would provide the same safely be applied immediately before health, proposed § 112.11 would require level of public health protection as the harvest. The farm operator would you to take appropriate measures to applicable requirement established in maintain a copy of the information minimize the risk of serious adverse this part (including meeting the same provided by the agent as documentation health consequences or death from the microbiological standards, where that the alternative measure was based use of, or exposure to, your covered applicable) and would not increase the on sound science. When FDA becomes produce by preventing the introduction likelihood that your covered produce aware of such information, it is our of biological hazards into or onto your will be adulterated under section 402 of intention to include it in guidance, so produce or by taking measures to the FD&C Act, in light of your covered that farm operators can also rely on FDA provide reasonable assurances that the produce, practices, and conditions, guidance for such alternative measures. produce is not adulterated under section including agro-ecological conditions As proposed in § 112.12(a), you may 402 of the FD&C Act. Such measures and application interval. We do not establish alternatives to the following might include, for example, conducting propose to require you to submit such requirements: a root cause investigation to try to scientific data or information to us for (1) The requirements in § 112.44(c), determine the source of the review or approval prior to marketing. for testing water, and taking action contamination, making appropriate However, we would require that you based on test results, when agricultural changes to your conditions and maintain a record of any such scientific water is used during growing operations practices suggested by the root cause data or information, including any for covered produce (other than sprouts) investigation, including to produce in analytical information, and make such using a direct water application method; other fields, as appropriate, determining data and information available to us to (2) The composting treatment the extent of the impact of the root evaluate upon request. processes required in § 112.54(c)(1) and cause (i.e., within the suspect field and Proposed § 112.12(c) clarifies that the (2); in other fields), and excluding scientific data and information used to (3) The minimum application interval adulterated produce from commerce. support an alternative to a requirement established in § 112.56(a)(1)(i) for an We note, however, that we do not may be developed by you, available in untreated biological soil amendment of intend for proposed § 112.11 to suggest the scientific literature, or available to animal origin; and that you would need to take measures you through a third party, and further (4) The minimum application interval to exclude animals from outdoor provides that documentation of such established in § 112.56(a)(4)(i) for a growing areas, to destroy animal data and information must be biological soil amendment of animal habitats near your outdoor growing established and maintained in origin treated by a composting process.

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Under proposed § 112.12(a)(1), you direct water application method for than what is necessary for minimizing may establish an alternative to the growing covered produce other than the likelihood that covered produce that requirements, established in proposed sprouts as long as it was applied before is grown in soils amended with an § 112.44(c) for testing water, and taking the start of the scientifically established untreated biological soil amendment, action based on test results when application interval (i.e., at a certain and is reasonably likely to contact the agricultural water is used during number of days before harvest or soil after application, pose to the public growing operations for covered produce earlier). Therefore, we tentatively health. These circumstances could (other than sprouts) using a direct water conclude that it would be appropriate to include differences in likelihood of application method. Under proposed allow for alternatives to the contamination posed by the specific § 112.44(c), you must test the quality of requirements in proposed § 112.44(c). feedstock, application method or water you use during growing activities Under proposed § 112.12(a)(2), you treatment method, especially given the for covered produce (other than sprouts) may establish an alternative to the potential for new innovations in such in accordance with one of the treatment processes, established in methods. appropriate analytical methods in proposed § 112.54(c)(1) and (2), for Under proposed § 112.12(a)(4), you proposed subpart N. If you find that composting, provided you comply with may establish an alternative to the there is more than 235 CFU (or MPN, as § 112.54(c)(3). The processes established minimum application interval of 45 appropriate) generic E. coli per 100 ml in § 112.54(c)(1) and (2) as scientifically days, established in proposed for any single sample or a rolling valid controlled composting processes § 112.56(a)(4)(i), for a biological soil geometric mean (n=5) of more than 126 demonstrated to satisfy the microbial amendment of animal origin treated by CFU (or MPN, as appropriate) per 100 standard in § 112.55(b) for Salmonella a composting process in accordance ml of water, you must immediately and for fecal coliforms are: (1) Static with the requirements of proposed discontinue use of that source of composting that maintains aerobic (i.e., § 112.54(c) that satisfies the microbial agricultural water and/or its distribution oxygenated) conditions at a minimum of standard in proposed § 112.55(b), and ° ° system for the uses described in that 131 F (55 C) for 3 days and is followed that is reasonably likely to contact paragraph and before you may use the by adequate curing, which includes covered produce after application. As water source and/or its distribution proper insulation; and (2) Turned discussed in section V.F. of this system again for those uses, you must composting that maintains aerobic document, we are proposing a multiple- conditions at a minimum of 131 °F (55 hurdle approach to minimizing the either: (1) Re-inspect the entire ° agricultural water system under your C) for 15 days, with a minimum of five likelihood of contamination by addition control, identify any conditions that are turnings, and is followed by adequate of an application interval of 45 days to reasonably likely to introduce known or curing, which includes proper any biological soil amendment of reasonably foreseeable hazards into or insulation. We tentatively conclude that animal origin treated by composting that onto covered produce or food-contact it would be appropriate to allow for the is reasonably likely to contact covered surfaces, make necessary changes, and use of other static or turned composting produce after application. This time retest the water to determine if your protocols that maintain conditions for a period has been shown to be effective changes were effective, or (2) treat the combination of temperatures and time when the population of the pathogen is water in accordance with the other than the temperature and times minimal (Ref. 104) as can be expected requirements of § 112.43. As discussed specified in proposed §§ 112.54(c)(1) of a fully composted biological soil and (2), and is followed by adequate amendment of animal origin. This in section V.E. of this document, we curing, which includes proper multiple hurdle approach and time considered several factors and insulation, if they achieve the same interval has also been utilized in current ultimately determined that the level of pathogen reduction (i.e., meet industry standards for leafy greens (Ref. microbial standard in proposed the microbial standard in § 112.55(b)). 31). We seek comments on this § 112.44(c), which is based on certain In this sense, the microbial standards proposal. We have also tentatively aspects of U.S. EPA’s recreational water would provide a performance standard; concluded that, under certain standards is appropriate for the uses of practices that meet this objective circumstances, the application interval agricultural water covered by proposed measure would be acceptable. It would in § 112.56(a)(4)(i) may be more than § 112.44(c). We seek comment on this be your responsibility to consider the what is necessary for minimizing the approach. moisture content, pH, carbon to nitrogen likelihood of contamination of covered However, we acknowledge that in ratio (C:N), feedstock, and any other produce that is grown in soils amended specific circumstances an alternative appropriate consideration needed with a treated biological soil standard (e.g., a standard that applies an during composting to adequately amendment, and that is reasonably application interval (time between achieve the microbial standards of likely to contact the soil after application and harvest) in place of the proposed § 112.55(b). application. These circumstances could 112.44(c) water standard, but is limited Under proposed § 112.12(a)(3), you include differences in likelihood of to a specific commodity or commodity may establish an alternative to the contamination posed by the specific group and region) may be appropriate if minimum application interval of nine feedstock, application method or the alternative standard is shown to (9) months, established in proposed treatment method, especially given the provide the same level of public health § 112.56(a)(1)(i), for an untreated potential for new innovations in such protection as the standard in proposed biological soil amendment of animal methods. § 112.44(c) and not to increase the origin that is reasonably likely to As noted above, in any use of likelihood that the covered produce will contact covered produce after alternatives permitted in § 112.12(a)(1) be adulterated. For example, we are application or for a compost agricultural through § 112.12(a)(4), in accordance working with USDA and other tea that contains compost agricultural with proposed § 112.12(b), you would stakeholders to facilitate research into tea additives. As discussed in section be required to have adequate scientific application intervals that would be V.F of this document, we have data or information to support a commodity- and region-specific, such tentatively concluded that, under conclusion that the alternative would that water not meeting the proposed certain circumstances, the application provide the same level of public health § 112.44(c) standard could be used in a interval in § 112.56(a)(1)(i) may be more protection as the requirement specified

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in the proposed rule and would not resources for worker training. Several the Produce Safety Alliance (PSA), increase the likelihood that your comments pointed out difficulties in which is a public-private partnership covered produce will be adulterated training due to the transient or short established to provide educational under section 402 of the FD&C Act. term nature of farm workers and due to outreach assistance to fresh produce Further, in accordance with proposed the seasonal relocation of their growers and packers. This program is in § 112.12(c), you must establish and operations. In addition, comments the process of creating training materials maintain documentation of such expressed concern over the cost of that will be both region- and scientific data or information, which implementation, including regular commodity-specific. We expect these may be developed by you, available in refresher courses and training materials, materials to be standardized, multi- the scientific literature, or available to and the reliability of third-party training formatted, and multi-lingual, and you through a third party. We are materials. One comment requested that available in pictorial format to help working with USDA and other individuals responsible for the training overcome literacy issues. Specific focus stakeholders to conduct research on program and materials should ensure areas for the PSA include GAPs and co- relevant alternative practices and intend that curricula are updated to reflect any management education and outreach to make the results of that research new scientific information. efforts for produce farmers and packers, available in the future. We seek We believe that adequate and with special emphasis on small-scale comment on whether we should require appropriate training of personnel who operations. This alliance will also you to notify FDA of your conclusion to handle covered produce or food-contact include a train-the-trainer lesson plan establish or use an alternative that is surfaces, or who are engaged in the and an education outreach program permitted under §§ 112.12(a)(1) through supervision thereof, is an essential delivery for farmers, trainers, and (a)(4), and whether we should require component of standards for produce regulators. We intend to explore the you to submit relevant scientific data or safety. Regardless of the nature of the need for additional such partnerships, information to FDA as part of such a farm workers, we propose that they as appropriate, to address any notification. must receive training upon hiring, at the commodity-specific needs for outreach beginning of each growing season, and and assistance. We welcome comments C. Subpart C—Standards Directed to with periodic updates as necessary in Personnel Qualifications and Training and suggestions for training order to prevent contamination of development strategies. As proposed, subpart C discusses covered produce. Farm workers need to minimum standards directed to know how to recognize potential 2. Proposed Requirements personnel qualifications and training contamination problems (e.g., a leafy Proposed § 112.21 would establish that are reasonably necessary to green vegetable contaminated with requirements for the qualifications and minimize the risk of serious adverse manure) and to be trained to know what training for personnel who handle health consequences or death from the to do when those situations present (contact) covered produce or food- use of, or exposure to, covered produce, themselves. The farm worker is a key contact surfaces, or who are engaged in including those reasonably necessary to component in the food chain for the supervision thereof. Having prevent the introduction of known or ensuring the safety of covered produce. personnel follow proper food hygiene reasonably foreseeable hazards into No matter the transient nature, any practices, including personal health and covered produce, and to provide worker can be a potential pathway for hygiene, can reduce the potential for on- reasonable assurances that the covered contamination of produce during farm contamination of covered produce. produce is not adulterated under section growing, harvesting, packing, and Educating personnel who conduct 402 of the FD&C Act. holding (e.g., because of hygiene issues covered activities in which they contact or illness) or fail to identify a situation 1. Comments Related to Proposed covered produce and supervisors about that may result in contamination of the Provisions food hygiene, food safety, and the risks covered produce being grown, We received several comments in harvested, packed, or held if they are to produce safety associated with response to the 2010 FR notice that not cognizant of proper food safety illnesses and inadequate personal addressed issues relevant to personnel procedures and standards. It is not hygiene is a simple step that can be qualifications and training. Several uncommon for workers to change based taken to reduce the likelihood of comments expressed concern over on season and location and, therefore, pathogens being spread from or by language and educational barriers proposed § 112.21(a) would require personnel to covered produce. greatly impeding the farm’s ability to personnel to receive training upon Most current FDA, private and effectively fulfill the training hiring and at the beginning of each international guidelines for the produce requirements for their field workers. growing season (if applicable). Proposed industry include provisions related to They also stressed the need for far § 112.21(a) would also require that training food handlers in the importance reaching, accurate, consistent, and well- personnel receive periodic updates as a of personal health and hygiene to food rounded training programs with skilled way of reminding them of the proper safety (Ref. 10. Ref. 20. Ref. 50. Ref. 48. trainers providing the same information procedures including any changes in Ref. 96. Ref. 26). As described in the to growers, processors and distributors. those procedures. Such updates may not QAR, FDA’s follow-up farm Comments further suggested that require full training sessions, but only investigations in response to outbreaks training materials should have short descriptive sessions to ensure that and contamination events identified addendums to reflect the differences all personnel remain aware of all poor worker health and hygiene, unsafe among the varied growing regions, procedures necessary to maintain the produce handling and storage practices, commodities, and production practices safety of produce. and specifically poor training in these and processes, as well as train-the- Together with the USDA, Cornell areas, as likely contributing factors to trainer programs for individuals University’s National GAPs program, these events. This information responsible for training farm workers. the Association of Food and Drug reinforces the importance of training Many firms also urged organizations, Officials (AFDO), and the National farm personnel, including supervisors, universities, and extension agencies to Association of State Departments of in food hygiene, food safety, employee share experiences and to provide Agriculture (NASDA), we have formed health and personal hygiene.

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Proposed § 112.21(a) would require compliance with this part. Proposed an employee displays repeated mistakes that all personnel (including temporary, § 112.21(b) would provide flexibility for or a fundamental misunderstanding of part time, seasonal and contracted how personnel become qualified to the correct procedures for handling personnel) who handle (contact) perform their assigned duties by covered produce, an appropriate action covered produce or food-contact recognizing multiple pathways to obtain may be to have the employee repeat surfaces and their supervisors receive the necessary qualifications: Training relevant training, or to attend a training that is appropriate to the (such as training provided on-the-job), comprehensive training course. If you person’s duties, upon hiring, at the in combination with education, or conclude that the employee may not beginning of each growing season (if experience (e.g., work experience have the skills to conduct certain applicable), and periodically thereafter. related to an employee’s current covered activities, an appropriate action Because ensuring that covered produce assigned duties). The standards in may be to train the employee for new is not contaminated is dependent on subparts C through O often involve responsibilities that are more suitable to personnel following proper food safety action by farm personnel (e.g., his or her skills. and hygiene practices, all personnel monitoring of animal intrusion, Proposed § 112.22(a) would require who contact covered produce and food- inspecting agricultural water system) that, at a minimum, all personnel who contact surfaces must receive training that require specific knowledge, skills handle (contact) covered produce when hired, before they participate in and abilities, without which the during covered activities must receive the growing, harvest, packing or holding standard could not be properly training that would include: (1) of covered produce in which they achieved. Proposed § 112.21(b) requires Principles of food hygiene and food contact covered produce, and must be that those farm personnel have the safety (proposed § 112.22(a)(1)); (2) the periodically reminded about the need to training so that they will have the importance of health and personal follow these practices through refresher necessary knowledge, skills, and hygiene for all personnel and visitors, training. When a farm hires workers abilities to perform their duties. including recognizing symptoms of a after the beginning of a growing season, Proposed § 112.21(c) would establish health condition that is reasonably these workers would need to be trained requirements for training to be likely to result in contamination of upon hiring. Because the farm does not conducted in a manner that is easily covered produce or food-contact employ these workers at the beginning understood by personnel being trained. surfaces with microorganisms of public of the first growing season, the The goals of training cannot be achieved health significance (proposed requirement for training at the if the person receiving the training § 112.22(a)(2)); and (3) the standards as beginning of each growing season would cannot understand it. Training could be applicable to the employee’s job not be applicable to those workers until understood by personnel being trained responsibilities, including those the beginning of the next growing if, for example, it was conducted in the established by FDA in subparts C season, if they are still employed by the language that employees customarily through O of this part (proposed farm at that time. Managers and speak and at the appropriate level of § 112.22(a)(3)). supervisors must have the necessary education. In some cases in may be We tentatively conclude that the knowledge of food safety and hygiene necessary to use easily understood broad topic areas addressed in proposed principles and practices to be able to pictorials or graphics of important § 112.22(a) are those minimum topic assess whether their staff are following concepts (Ref. 105). areas necessary to be covered during appropriate practices, and take the Proposed § 112.21(d) would establish training for all employees who handle necessary action to remedy any requirements for training to be repeated (contact) covered produce. Training in deficiencies, which could include on- as necessary and appropriate in light of the principles of food hygiene and food the-spot training for their staff. observations or information indicating safety are necessary to provide an Periodic refresher training for all that personnel are not adequately overall framework for job performance. relevant personnel, including managers meeting standards established by FDA Training in health, hygiene, and disease and supervisors, is necessary to ensure in subparts C through O of the rule. The control can teach workers how to continual awareness of important food goals of training are not achieved if the minimize the likelihood of transferring safety and hygiene principles. It is also persons receiving the training do not pathogens to covered produce. These important when new information is correctly implement those standards topics are covered in several currently available about practices that may taught. Moreover, repeated training as used guidance documents (Ref. 10. Ref. contribute to foodborne illness or when, proposed in § 112.21(d) is necessary 20. Ref. 50. Ref. 48. Ref. 96). In addition, for that reason or other reasons, changes when an employee that does not follow training in the specific standards in the farm’s procedures are put in the correct food safety protocol, because established in subparts C through O of place. For example, during the past such behavior may increase the this part which are necessary for the decade several segments of the produce likelihood of introducing a food safety employee to use during the course of industry reviewed and revised their hazard to covered produce. When an their duties will increase the likelihood industry guidelines or developed new employee requires additional training, it that those standards will be guidelines to address current food safety may consist of informal on-the-spot implemented correctly and effectively. concerns relative their specific instruction to focus on those measures We seek comments on the scope, commodity (i.e., lettuce, tomatoes, not being adequately implemented as frequency, and methods outlined in the sprouts, and cilantro). opposed to more comprehensive proposed training sections of the Proposed § 112.21(b) would require training. For example, if you observe an proposed rule. that all personnel (including temporary, employee commit a minor error, such as Proposed § 112.22(b) would require part time, seasonal and contracted an inappropriate method for recording that persons who conduct covered personnel) who handle (contact) monitoring information in a log, an harvest activities for covered produce covered produce or food-contact appropriate action could be to show the also receive training that includes all of surfaces and their supervisors have the employee the correct method of the following: (1) Recognizing covered training, in combination with education recording the information and contrast produce that should not be harvested, or experience, to perform the person’s this with the inappropriate method the including covered produce that may be assigned duties in a manner that ensures employee had been using. However, if contaminated with known or reasonably

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foreseeable food safety hazards employment of the harvest crew Alliance course. We have no plans to (proposed § 112.22(b)(1)); (2) inspecting company. Farms on which such harvest publish a list of ‘‘approved’’ courses harvest containers and equipment to crews work could request certification other than the Alliance course materials. ensure that they are functioning from the harvest crew company that Proposed § 112.23 would require that properly, clean, and maintained so as their workers have received the required you assign or identify personnel to not to become a source of contamination training. We seek comment on the supervise (or otherwise be responsible of covered produce with known or feasibility of the proposed training for) your operations to ensure reasonably foreseeable food safety requirements, particularly with respect compliance with the requirements of the hazards (proposed § 112.22(b)(2)); and to harvest activities. rule. Oversight by a qualified individual (3) correcting problems with harvest Proposed § 112.22(c) would require is essential to the effective containers or equipment, or reporting that at least one supervisor or implementation of the rule. Under such problems to the supervisor (or responsible party for your farm proposed § 112.23, the personnel that other responsible party), as appropriate successfully complete food safety you assign or identify to supervise (or to the person’s job responsibilities training at least equivalent to that otherwise be responsible for) your (proposed § 112.23(b)(3)). received under standardized curriculum operations may be a single person We tentatively conclude that the topic recognized as adequate by the Food and (including yourself), or may be a team areas addressed in proposed § 112.22(b), Drug Administration. Experience at of individuals, each with specific areas in addition to § 112.22(a), are those farming does not necessarily convey of responsibility (e.g., you may assign or minimum topic areas necessary to be knowledge of food safety, particularly identify separate persons to be covered during training for persons who that of microbial food safety hazards, responsible for your water distribution conduct harvest activities. Harvest and therefore specialized training is system, your harvest activities, your workers need to learn how to recognize needed to address the specific concerns sanitary accommodations, and your produce that should not be harvested of on-farm food safety. The purpose of packing activities). (such as rotten or decayed fruit, Proposed § 112.30(a) would require training a supervisor or other ‘‘drops,’’ or harvestable items that have that you establish and keep records responsible party is so that person can been contaminated with feces), because required under subpart C in accordance help train other employees, recognize not harvesting such covered produce with the requirements of subpart O of conditions that could lead to would be the first opportunity to the rule. Proposed § 112.30(b) would contamination of covered produce, and prevent that produce from entering require that you establish and keep commerce, and as a practical matter take action to correct those conditions. records that document required training may be the only such opportunity (for As discussed in section II.D. of this of personnel, including the date of the example, during a field-pack operation document, FDA has, together with training, the topics covered, and the with no subsequent culling stage). USDA AMS, established the jointly person(s) trained. An example of Proposed § 112.112 would require that funded PSA, a public-private records that would comply with farms take all measures reasonably partnership that will develop and proposed § 112.30(b) is an attendance necessary to identify and not harvest disseminate science- and risk-based sheet with the date, list of those in covered produce that is visibly training and education programs to attendance, and the particular topics contaminated with animal excreta. provide produce growers and packers covered (such as proper hand washing Harvest workers must be trained to with fundamental, on-farm food safety or how to collect samples for water both recognize this condition and to knowledge, starting in advance of this testing). The records required by avoid harvesting covered produce that proposed rule and continuing after the proposed § 112.30(b) would enable you exhibits the condition. Harvest workers final regulation is promulgated. A first to track the training personnel receive, also need to know how to inspect phase of PSA’s work is intended to thereby enabling you to identify harvest containers and equipment to assist growers, especially small growers, personnel and training topics for ensure that they are functioning in establishing food safety programs periodic updates and personnel that properly, clean, and maintained so that consistent with the GAPs Guide and have the prerequisite training for they will not act as a source of other existing guidances and assignment to certain responsibilities. contamination or lead to damage of requirements so that they will be better Such records would enable you to covered produce (damaged produce is positioned to comply with a final document that a person has, as would more likely to harbor pathogens, and at produce rule. As this rulemaking be required under proposed §§ 112.21(a) a greater population, than is sound progresses, FDA will work to ensure and (b), successfully completed training produce (Ref. 59. Ref. 106)). Harvest that the PSA materials are modified, as as appropriate to the person’s duties, workers also need to know how to needed, to be consistent with the upon hiring and periodically thereafter, correct problems with harvest requirements of this rule. Included in including the principles of food hygiene equipment or containers when they that material will be the standardized and food safety and also the training encounter them, or need to know that curriculum against which FDA intends that would be specific to a person’s they should report such problems to to compare other training programs. tasks and responsibilities. someone who would be responsible for After reviewing the final draft of the ensuring that the problem is corrected. PSA training materials, FDA intends to D. Subpart D—Standards Directed to These topics are covered in several publish a notice of availability of the Health and Hygiene currently used relevant documents (Ref. documents in the Federal Register. We As proposed, subpart D discusses 8. Ref. 33. Ref. 18. Ref. 89. Ref. 84). We would encourage trainers outside the science-based minimum standards acknowledge the challenge these PSA to evaluate their courses, past, directed to health and hygiene that are training requirements may pose to farms present, and future, against the PSA reasonably necessary to minimize the that employ contracted harvest crews. In materials when they become available risk of serious adverse health such cases, we expect that the harvest and to modify or adapt curricula, where consequences or death from the use of, crew company could provide the necessary, to ensure that they are or exposure to, covered produce, required training to workers, who move consistent with, and provide at least an including those reasonably necessary to from farm to farm under the equivalent level of instruction to, the prevent the introduction of known or

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reasonably foreseeable hazards into Bacteria, viruses, and parasites are is excluded from handling covered covered produce, and to provide frequently transmitted from person to produce if the wound could be a source reasonable assurances that the produce person and from person to food, of microbial contamination. Proposed is not adulterated under section 402 of particularly through the fecal-oral route § 112.31(b)(1) is similar to requirements the FD&C Act. (Ref. 95. Ref. 96. Ref. 97. Ref. 98. Ref. in current §§ 110.10(a) and 111.10(a) 93). Several of the provisions of and to provisions in our GAPs Guide 1. Comments Relevant to Proposed proposed subpart D are similar to (Ref. 10), the AFDO Model Code, Provisions requirements in our Current Good various produce industry guidelines We received some comments in Manufacturing Practice regulations for (Ref. 89. Ref. 84. Ref. 99), and a response to the 2010 FR notice that food and for dietary supplements marketing agreement (Ref. 31), and the addressed issues relevant to health and (§ 110.10 and 111.10, respectively), and Codex Code (Ref. 96). hygiene. Several comments noted the to provisions in our GAPs Guide (Ref. Proposed § 112.31(b)(2) would require challenges of enforcing use of gloves 10), the AFDO Model Code (Ref. 20), that you instruct your personnel to and clean clothes. Others expressed various produce industry guidelines notify their supervisor(s) (or a concerns related to identifying sick (Ref. 46. Ref. 44), a marketing agreement responsible party) if they have, or if employees who could contaminate (Ref. 31), and international guidelines there is a reasonable possibility that covered produce or food-contact (Ref. 96). they have, an applicable health surfaces, while another comment asked Proposed § 112.31 would require that condition. Consistent with the training about potential requirements on you take measures necessary to prevent requirement proposed in § 112.22(a)(2), hygienic practices and questioned ill or infected persons from we are proposing this requirement as a whether hand jewelry could contaminating covered produce with measure specifically directed at contaminate produce such as leafy microorganisms of public health preventing sick or infected persons from greens. significance. Proposed § 112.31(a) contaminating covered produce or food- We recognize the importance of taking would require that you take measures to contact surfaces and to emphasize that appropriate measures to prevent sick or prevent contamination of covered individual workers have a infected persons from contaminating produce and food-contact surfaces with responsibility—every day—to take covered produce or food-contact microorganisms of public health action to prevent contamination due to surfaces. In proposed § 112.22(a)(2), we significance from any person with an their own illness or infection. In a small propose to require training of personnel applicable health condition (such as or very small business, such as a farm to recognize symptoms of a health communicable illnesses that present a largely operated by a husband and wife, condition that is reasonably likely to public health risk in the context of the impact of proposed § 112.31(b)(2) result in contamination of covered normal work duties, infection, open would, in essence, be for a sick worker produce or food-contact surfaces with lesion, vomiting, or diarrhea). to take appropriate steps to exclude microorganisms of public health Proposed § 112.31(b)(1) would require himself or herself from working in any significance. The proposed that you exclude any person from operations that may result in requirements for standards directed to working in any operations that may contamination of covered produce or health and hygiene focus on result in contamination of covered food-contact surfaces with pathogens. maintaining adequate personal produce or food-contact surfaces with Proposed § 112.31(b)(2) is similar to cleanliness. Gloves can provide a barrier microorganisms of public health requirements in current §§ 110.10(a) and to reduce the potential for significance when the person (by 111.10(a) and to provisions in the AFDO contamination; however, gloves medical examination, the person’s Model Code (Ref. 20), and a produce themselves can transfer pathogens to acknowledgement, or observation (for industry guideline ( (Ref. 46). We seek covered produce if they become example, by a supervisor or responsible comments on the notification and other contaminated. Therefore, while we are party)) is shown to have, or appears to proposed requirements related to not proposing to require the use of have, an applicable health condition, workers health. gloves, we are proposing to require the until the person’s health condition no Proposed § 112.32 would require that proper use of gloves when workers wear longer presents a risk to public health. personnel use certain hygienic them (proposed § 112.32(b)(4)). Clothes Applicable health conditions would not practices. Proposed § 112.32(a) would should be adequately clean if by virtue include non-communicable diseases require that personnel who work in an of type of operation the workers are such as cancer, diabetes, or high blood operation in which covered produce or performing, the clothes could pressure, or non-communicable food-contact surfaces are at likelihood of potentially contaminate covered conditions such as pregnancy, which contamination with known or produce with pathogens. would not present a likelihood of reasonably foreseeable hazards use contamination to covered produce or hygienic practices while on duty to the 2. Proposed Requirements food contact surfaces. For example, if an extent necessary to protect against such Proposed subpart D would require employee tells you that his or her contamination. Hygienic practices can that you take those measures that we physician has diagnosed that the prevent introduction of microbial (such tentatively conclude are reasonably employee has a fever, and the employee as bacteria and viruses that could be necessary to prevent personnel and normally handles your covered produce, present in saliva or on skin) visitors from introducing known or you must take steps to ensure that the contamination of covered produce (Ref. reasonably foreseeable hazards into or employee does not come into contact 108). Inadequate hygienic practices onto covered produce or food-contact with your covered produce because the among workers have been associated surfaces. As discussed above (see fever may suggest that the employee has with outbreaks transmitted by various sections I.A. of this document, and an infection and there is a reasonable produce commodities, including QAR), people can carry a wide variety possibility of contamination. Likewise, strawberries, green onions, mamey, leaf of pathogens (including hepatitis A if you see that an employee has an open lettuce, and basil (Ref. 107). Proposed virus, Salmonella, E. coli O157:H7, wound or sore, and the employee § 112.32(a) is similar to requirements in Shigella, Cyclospora, and normally handles covered produce, you current §§ 110.10(b) and 111.10(b) and Cryptosporidium (Ref. 93) (Ref. 107). must take steps to ensure that he or she to provisions in our GAPs Guide (Ref.

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44), the AFDO Model Code (Ref. 20), with consumption of contaminated contact. Hand-washing, when done various produce industry guidelines produce (Ref. 109). effectively, can eliminate both resident (Ref. 46. Ref. 44), a marketing agreement Proposed § 112.32(b)(3) would require bacterial contamination (such as on the (Ref. 31), and the Codex Code (Ref. 96). that personnel wash hands thoroughly, hands of a worker who may not realize Proposed § 112.32(b) would require including scrubbing with soap and he is ill or infected) and transient that personnel who handle (contact) running water that satisfies the microbial contamination (such as covered produce use specific hygienic requirements of § 112.44(a) (as bacteria, viruses, and parasites that gets practices to satisfy the requirements of applicable) for water used to wash onto hands through contact with the proposed § 112.32(a). Proposed hands, and that personnel dry hands environment) (Ref. 110). As a result, § 112.32(b)(1) would require the specific thoroughly using single-service towels, hand-washing is a key control measure practice of maintaining adequate clean cloth towels, sanitary towel in preventing contamination of covered personal cleanliness to protect against service or other adequate hand drying produce and food-contact surfaces (Ref. contamination of covered produce and devices on specified occasions. Those 26). The effectiveness of hand-washing food-contact surfaces. Requiring that specified occasions include before is determined by multiple factors, workers maintain adequate personal starting work; before putting on gloves; including whether or not soap is used, cleanliness is similar to requirements in after using the toilet; upon return to the the quality of water used, the duration current §§ 110.10(b) and 111.10(b) and work station after any break or other of scrubbing and rinsing, and whether to provisions in the Codex Code (Ref. absence from the work station; as soon hands are dried. Soap serves as an 96). We would expect that maintaining as practical after touching animals emulsifier that enables dirt and oil to be adequate personal cleanliness would (including livestock and working suspended and washed off (Ref. 110). include wearing adequate outer animals) or any waste of animal origin; Rinsing hands without using soap, and garments as necessary and appropriate and at any other time when the hands not drying hands after washing, can to protect against contamination of may have become contaminated in a promote the spread of microorganisms. covered produce and food-contact manner that is reasonably likely to lead For example, rinsing hands without surfaces. Outer garments (e.g., smocks, to contamination of covered produce using soap can loosen microorganisms aprons, or coveralls worn over a with known or reasonably foreseeable without removing them, leaving the worker’s personal clothing) may be hazards. Under proposed § 112.32(b)(3), microorganisms more readily necessary and appropriate when a we would not expect workers to transferable to the next surface touched worker conducts an activity that has immediately stop work and wash their (Ref. 110). An investigation in follow-up increased potential to contaminate the hands each time hands become soiled to an outbreak of foodborne illness worker’s personal garments with during the usual course of farm work caused by E. coli O157:H7 in Florida hazards that could be transferred to with dirt or plant litter. However, we found an association between illness covered produce or food-contact would expect workers to have sufficient and visits to fairs where visitors came in surfaces during subsequent activities in training to recognize potential sources contact with animals, and found that which the worker may contact covered of hazards and to wash their hands persons who washed their hands with produce. For example, a worker’s when appropriate. We tentatively soap and water had a decreased personal clothing could become conclude that proposed § 112.32(b)(3) likelihood of illness (Ref. 111). Drying contaminated with pathogens while a provides sufficient flexibility for hands is important because wet skin is worker shovels manure, and such operations to provide running water in more likely to transmit microorganisms contamination could be transferred from a manner best suited to the conditions than dry skin (Ref. 110). In addition, the clothing to covered produce if the of use. For example, water can be hand-drying has been demonstrated to worker subsequently harvests covered supplied by a Public Water System, remove bacteria from the hands and produce wearing the same clothes. An private well, or other source satisfying decrease ‘‘touch-contact-associated apron, smock, or coverall worn over the the requirements of § 112.44(a) through bacterial transfer’’ after hand-washing worker’s personal clothing while plumbed connections to building (Ref. 112). Proposed § 112.32(b)(3) does shoveling the manure could simply be faucets (e.g., inside a packing house) to not prohibit use of hand sanitizers as a removed before the worker moves on to supply running water throughout the part of the hand washing process. a harvest activity, which would reduce facility. Alternatively, water supplied However, our review of hand washing the likelihood of contaminating covered from sources above and used to fill produce during the subsequent harvest clean, portable water containers suited indicates that soap and water are far activity. We intend to provide further to field use (such as a carboy, tank, more effective than sanitizers in information about adequate worker water buffalo, or similar container) removing pathogens. The effectiveness personal cleanliness in guidance. fitted with a valve, spout, or spigot such of hand sanitizers has been shown to be Proposed § 112.32(b)(2) would require that water released passes over the highly dependent upon the removal of that personnel avoid contact with hands also can provide adequate organic material from the hands prior to animals other than working animals, running water for washing hands. Under their use, as the presence of dirt, grease, and that personnel in direct contact proposed § 112.44(a), with certain or soil significantly reduces their with working animals take appropriate exceptions set forth in proposed effectiveness in eliminating bacteria on steps to minimize the likelihood of § 112.45, you must test the quality of hands (Ref. 107). contamination of covered produce. water used for hand washing during and Proposed § 112.32(b)(3) is similar to Pathogens can be directly transmitted after harvest to ensure that there is no provisions in our GAPs Guide (Ref. 10), from animals to people when persons detectable generic E. coli (see section the AFDO Model Code (Ref. 20), various touch, pet, feed, or are licked by animals V.E. of this document). produce industry guidelines (Ref. 89. because animal hair, fur, saliva and skin Workers often touch produce with Ref. 84. Ref. 99), a marketing agreement can harbor pathogens (Ref. 98. Ref. 99. their bare hands, and the produce (Ref. 31), and the Codex Code (Ref. 96). Ref. 100). For example, transmission of covered by this rule would not Several differences exist between the pathogen Giardia lamblia from necessarily have a ‘‘kill step’’ to proposed § 112.32(b)(3) and analogous animals to humans was linked to an adequately reduce pathogens that could provisions in current §§ 110.10(b) and outbreak of foodborne illness associated be transmitted through bare-hand 111.10(b). For example, proposed

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§ 112.32(b) would not specify, in these requirements in the proposed ensure that visitors comply with such addition to the requirements for hand provisions for workers to wash their policies and procedures. Proposed washing, that hands also be sanitized if hands as well as in the proposed § 112.33(c) would require that you make necessary to protect against microbial provisions directed to hand-washing toilet and hand-washing facilities contamination, while both §§ 111.10(b) facilities. We seek comment on the accessible to visitors. In contrast to food and 111.10(b) have such a requirement. hand-washing proposals described processing facilities, on-farm visitors We tentatively conclude that the above. often enter areas where covered produce circumstances where use of a hand Proposed § 112.32(b)(4) would require is grown and harvested, particularly on sanitizer as an additional measure to that, if you choose to use gloves in farms that offer consumers an reduce likelihood of contamination with handling covered produce or food- opportunity to pick their own fruits and pathogens would be limited on a farm. contact surfaces, you maintain gloves in vegetables. As with workers, visitors can Hand sanitizers are less likely to be an intact and sanitary condition, and transmit pathogens to covered produce effective on a farm than in a processing that you replace such gloves when you and food-contact surfaces. Thus, we are plant, since growers’ hands are more are no longer able to do so. We are not proposing to require that farms address likely to get dirty during production on proposing to require the use of gloves, the potential for visitors to contaminate a farm and the resulting presence of but gloves are used in many operations covered produce, even though we have organic material on the hands would to protect workers’ hands. While gloves no similar requirements in regulations impede the effectiveness of hand also provide a barrier that can reduce such as parts 110 and 111. Proposed sanitizers (Ref. 113). the potential for pathogens on workers’ § 112.33 is similar to provisions in our In addition, proposed § 112.32(b)(3)(v) hands to contaminate covered produce, GAPS Guide (Ref. 10), the AFDO Model would specifically require washing gloves themselves, whether re-usable or Code (Ref. 20), various produce industry hands after touching animals, a disposable, can transfer pathogens to guidelines (Ref. 89. Ref. 84. Ref. 99), a requirement that is not included in covered produce if the gloves become marketing agreement (Ref. 31), and the current § 110. We are proposing this contaminated (Ref. 26). If gloves are Codex Code (Ref. 96). A farm could requirement here because contact with used in handling covered produce or comply with these proposed animals is more likely to happen on a food contact surfaces, requiring that requirements by, for example, indicating farm. In addition, the National such gloves be either in an intact and the location of restrooms and hand- Association of State Public Health sanitary condition, or else be replaced, washing facilities accessible to visitors Veterinarians has recommend washing reduces the potential for the gloves to be and clearly posting rules applicable to hands after touching animals as a a source of contamination for covered visitors where they are likely to be seen protection against outbreaks of E. coli produce. Proposed § 112.32(b)(4) is and read at the beginning of a visitor’s O157:H7, Salmonella Enteritidis, similar to requirements in current visit, such as near the entrance or cash Cryptosporidium parvum, non-O157 §§ 110.10(b) and 111.10(b). Our GAPs register at a ‘‘pick-your-own’’ farm STEC, Salmonella typhimurium, and Guide (Ref. 10), various produce operation. Campylobacter jejuni (Ref. 111). industry guidelines (Ref. 89. Ref. 84. Proposed § 112.32(b)(3) also would Ref. 99) and the Codex Code (Ref. 96) E. Subpart E—Standards Directed to repeat some of the characteristics of an include specific provisions directed to Agricultural Water adequate hand-washing facility the use of gloves. The AFDO Model As proposed, subpart E discusses specified in proposed § 112.130 (i.e., Code (Ref. 20) and a marketing science-based minimum standards soap, running water of specified agreement (Ref. 31) direct farms to directed to agricultural water that are microbial quality, and adequate drying establish policies to ensure proper use reasonably necessary to minimize the devices). Currently, in our CGMP of gloves. It has been reported that glove risk of serious adverse health regulation for food facilities, § 110.37(e) use can foster a ‘‘false sense of security’’ consequences or death from the use of, identifies examples of how to achieve that can lead to less sanitary practices or exposure to, covered produce, compliance with the requirements for such as wearing the same pair of gloves including those reasonably necessary to an adequate hand-washing facility, but for extended periods of time without prevent the introduction of known or it does not repeat them in the cleaning them, or washing hands reasonably foreseeable hazards into requirement in § 110.10(b) regarding infrequently (Ref. 114). If your workers covered produce, and to provide workers washing their hands. In wear gloves, you should ensure that reasonable assurances that the produce proposed § 112.32(b)(3) (and in they know that wearing gloves in no is not adulterated under section 402 of proposed § 112.130), we are proposing way diminishes the importance of the FD&C Act. to identify specific characteristics of an washing hands, and that gloves must be 1. Comments Relevant to Proposed adequate hand-washing facility because maintained and replaced, when Provisions many of these facilities are likely to be necessary and appropriate. in outdoor growing areas and be Proposed § 112.33 would require that We received some comments in portable. Standard features that we have you take measures to prevent visitors response to the 2010 FR notice that come to expect as a matter of course in from contaminating covered produce addressed issues relevant to agricultural a hand-washing facility in a building and food-contact surfaces with water. Several comments expressed used for manufacturing/processing food microorganisms of public health concern that our proposed regulations may not be standard in a portable hand- significance. Proposed § 112.33(a) could have an adverse effect upon or be washing facility. Moreover, the outdoor would define a visitor as any person in conflict with on-farm conservation or nature of many areas where covered (other than personnel) who enters your land management practices efforts; or activities take place naturally presents covered farm with your permission. that they could set standards for workers with situations where they will Proposed § 112.33(b) would require that limiting all animal access to surface get dirt on their hands, and workers may you make visitors aware of policies and waters (e.g., by fencing or other barrier) be routinely handling food, with their procedures to protect covered produce or prohibit vegetation (normally used to bare hands, that will not be cooked to and food-contact surfaces from stabilize soil or for use as a natural adequately reduce pathogens. Therefore, contamination by people, and that you water filter) surrounding surface water we believe it is appropriate to repeat take all steps reasonably necessary to sources.

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In developing the provisions in costs and associated burden related to are proposing in addition in § 112.45(b) proposed part 112, we consulted with testing of agricultural water, including that untreated surface waters must be USDA’s National Organic Program and pathogen testing, indicators, and tested more frequently than ground Natural Resources Conservation Service, frequency of testing. As described in water sources because surface U.S. Fish and Wildlife Service, and the section in the QAR, pathogen presence watersheds are subject to a greater EPA (Ref. 115) to take into consideration and distributions in the environment number of external forces that shape conservation and environmental and water systems can be expected to be their overall composition, chemistry, practice standards and policies sporadic, with survival dependent on a and microbial water quality (e.g., established by those agencies. We multitude of factors. Thus, broad erosion, run-off, dust, suspended recognize the importance of ensuring, to generalizations concerning their sediments). We seek comment on our the extent possible, that our proposed presence or persistence in water or on proposed approach. provisions are compatible with existing produce are problematic, and their A number of comments related to conservation practices in the detection difficult. Therefore, rather quantifying risks associated with the use management of agricultural water than testing for the presence or levels of of agricultural water as a function of systems. In proposed § 112.42(a)(1)–(5), various pathogenic microorganisms, we water source, time of application, we would require that you inspect your propose to use a microbial indicator as irrigation method, and commodity type. entire agricultural water system at the a monitoring measure to assess the Our research shows that this is an beginning of every growing season, potential for contamination. After extremely difficult task. In the QAR, we focused on identifying conditions that considering various microbial indicators considered various factors relevant to are reasonably likely to introduce of water quality (see section V.E.2. of produce production and harvesting, known or reasonably foreseeable this document), we tentatively conclude including water sources and use (See hazards into or onto covered produce or that generic Escherichia coli (E. coli) is the QAR document). Some conclusions food-contact surfaces. A similar best suited for this purpose. It can be related to likelihood of produce (re)inspection would be required in found in at least 90 percent of all human contamination associated with water proposed §§ 112.44(b) and (c) if the and animal feces (Ref. 116) and is most use can be drawn, although the water you use for certain purposes does closely associated with incidents of relevance of these findings and whether not meet the microbiological criteria fecal contamination (Ref. 107. Ref. 108. they can be generalized across described in those provisions. In each of Ref. 109. Ref. 110. Ref. 108. Ref. 111. commodities, regions, and climates is these provisions, however, we do not Ref. 112). There are multiple test not known. For example, Stine et al describe specific inspection findings methods, commercial kits, and formats (2005) (Ref. 109) and Song et al. (2006) likely to adversely affect microbial available at relatively low cost, and the (Ref. 117) provide strong evidence that water quality and relate them to specific accuracy, precision, and sensitivity of subsurface drip irrigation lowers the required actions. For example, we do these analytical testing options would likelihood of waterborne contamination not propose that vegetation surrounding meet the requirements in this proposed compared to furrow or overhead an on-farm pond be cut back and/or rule. Although the correlation between irrigation. These authors also suggest removed or that fencing must be used to generic E. coli and fecal contamination that proximity of the edible portion prevent access to a pond by wildlife and is strong, as discussed in section V.E.2. relative to water applied and surface texture of the edible portion play key domestic animals. We recognize that of this document, generic E. coli does roles in likelihood of contamination. each farm, State, region, or produce not always reliably predict the presence In addition, according to a WHO risk of pathogens despite fecal pollution commodity group may approach water assessment (Ref. 118) of wastewater use management differently with respect to being a known source of pathogenic in agriculture, pathogen (bacteria, the likelihood of contamination of microorganisms. This is explainable, protists, and viruses) die-off during the agricultural water and the use of however, considering the current interval between last irrigation and specific conservation practices that may understanding of pathogen occurrence consumption is approximately 1 log per be appropriate or consistent with and distribution described in the QAR day, although the rate varies with measures used to mitigate the likelihood and the taxonomic diversity of climatic conditions. Other measures that of contamination. Practices used for one waterborne pathogens (e.g., bacteria, can be protective include cessation of region or commodity may not be viruses, and protists). Thus, generic E. watering, choice of irrigation method appropriate for others based upon coli monitoring serves as a measure to (localized irrigation—bubbler, drip, historical experience. Under this assess the potential for fecal trickle is more protective than flood, proposed subpart, we would require contamination, not to directly predict furrow, or spray/sprinkler), and food that you address such issues only if they the presence of pathogens. preparation measures (washing) (Ref. are reasonably likely to contribute to Comments also emphasized that 118). It is difficult to determine to what contamination of covered produce, and microbial testing should be performed at extent this assessment can be applied to we would provide flexibility in the way a frequency dependent upon the results water systems that are not based on in which you address any identified of an assessment of the risks posed by wastewater use where high pathogen hazards, such that measures you your agricultural water system. We loads can be expected. Produce grown implement to mitigate such hazards can agree that the frequency should reflect with water of significantly higher water be consistent with your current the risk. In proposed § 112.45(a), with quality continues to be implicated in conservation practices. This approach certain exceptions, we propose to disease outbreaks (Ref. 119). These allows you to put in place measures you require you to test water used for certain outbreaks not only illustrate the deem most effective in addressing the purposes at the beginning of each challenge in assigning absolute risk potential for water contamination and to growing season, and every three months reduction values to measures used in assess the effectiveness of those thereafter during the growing season. the mitigation of risk, but also the measures as they may be reflected in We tentatively conclude that this sporadic nature of pathogen occurrence your microbial water quality data. frequency would provide sufficient and localized conditions leading to the We also received a number of information regarding the microbial persistence of pathogens in the comments expressing concern about quality of your agricultural water. We environment.

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A few comments recommended that precipitation levels or suspended pathogens to the surface water system equipment used to hold or convey water sediments in surface waters, providing from sources such as failing septic should be inspected to ensure that it is useful information about when and how systems and deposited animal feces clean. that water source can be safely used. (Ref. 123. Ref. 124). We agree that equipment used to hold Microbial water quality testing can be or convey water should be maintained performed using a variety of methods a. Microbiological Indicators of Water in a manner necessary to protect against that have been validated for water Quality contamination. In proposed 112.42(c), testing. A key element of any testing A primary consideration in we propose to require that all program is determining the indicator establishing a microbiological water agricultural water distribution systems organism or specific pathogen(s) and the quality testing program is the choice of must be adequately maintained as frequency of testing. The sensitivity of target organism(s). Two general necessary and appropriate to prevent the method is also important, although approaches are commonly used: Test for the water distribution system from being most test methods available today have the presence of an indicator organism(s) a source of contamination to covered sensitivities that match or exceed that may signal the presence of produce, food-contact surfaces, areas requirements for EPA drinking water pathogens or test for pathogens used for a covered activity, or water and FDA bottled water standards. themselves. In the United States, sources, including by regularly Surface water quality and pathogen bacterial indicators have a long history inspecting and adequately storing all monitoring studies reported in the of being used to demonstrate the safety equipment used in the system. In literature often quantify indicator of drinking water and adequacy of its addition, in proposed 112.42(b), we organisms or pathogens on a monthly treatment at the source. They have also propose to require that all agricultural basis. However, most studies do not been used to monitor the status of water sources that are under the control specifically address the impact of water drinking water in distribution systems of a covered farm (such as wells) must quality on produce safety (Ref. 115. Ref. and determine if surface waters are be adequately maintained by regularly 116. Ref. 117. Ref. 118). A lack of microbiologically safe for recreational inspecting each source and keeping the consensus among the different use (e.g., swimming) and shellfish source free of debris, trash, recommendations and approaches harvest (Ref. 123). domesticated animals, and other underscores the complexity and Bacterial fecal indicators are non- possible sources of contamination of uncertainty in water quality sampling pathogenic microorganisms that are covered produce to the extent and testing strategies. Nevertheless, a commonly found in the intestines of practicable and appropriate under the vast majority of studies that address warm-blooded animals that are easily circumstances. frequency of testing recommend that isolated and quantified as a measure of We seek comment on our proposals surface water sources should be fecal contamination and potential for and approach related to agricultural sampled more frequently than ground enteric pathogens. Desired water. water sources (Ref. 121). characteristics for effective indicator Two key determinants of an organisms include: Ease of detection; 2. Water Quality Testing, Indicators, and appropriate testing frequency emerge being present only when fecal Standards from this information: (1) Variability of contamination or pathogens are present; In this subsection, we present a the water source and (2) the extent to and, being in numbers that correlate technical discussion of issues related to which it can be protected. The with the amount of contamination, water quality such as testing samples, discussion above suggests that water numbers of pathogens and risk of microbial quality indicators, and obtained from a public water source is illness. Survival times of indicator microbial quality standards. We discuss least likely to be a vehicle for pathogen organisms in sediments and in water these issues in greater detail in this contamination of produce, followed by should be equal (or greater) to those for subsection to further support the water obtained from deep underground pathogens and their detection should be provisions proposed below related to aquifers, shallow wells, and surface accomplished by simple, rapid methods water quality testing and microbial waters, in that order. This is consistent at low cost. Indicator microorganisms indicators. with findings reported in the literature are widely used in water quality testing A fundamental component in (Ref. 122. Ref. 29). For purposes of because of their broad utility across assessing the adequacy of water for its defining likelihood of contamination, many types of water but no single intended use is a routine sampling and we further divide surface water into two indicator that is universally accepted microbial testing program (Ref. 120. Ref. types, based on the potential for (Ref. 123). 29). Water sampling and testing allows contamination (through runoff), and the Pathogen detection has the obvious for informed decisions regarding the degree to which potential contamination advantage of directly targeting management of water use, such as can be recognized and controlled (i.e., microorganisms in water that are a risk choosing a water source and combining (1) surface waters where runoff is to public health. However, sampling that selection with, for example, the difficult to recognize and control water for pathogens may present irrigation method for a specific because of the size of the watershed additional challenges, including larger commodity or time period prior to (e.g., river or lake) and (2) surface waters sample sizes to facilitate detection, harvest. Testing for microbial quality of where runoff can be easily detected and inherently higher costs, and the wide water can identify possible fecal which can be managed so as to protect array of potential target pathogens (i.e., contamination at the water source or in them from runoff (e.g., on-farm reservoir the presence or absence of one pathogen a section of its distribution system (e.g., or pond)). Runoff is used here in may not predict for the presence or line break). Additionally, regular testing differentiating the likelihood of absence of other pathogens). data may be used to identify seasonal contamination of surface water because A number of indicator (or other) trends and highlight areas of it has the potential to carry pathogens microorganisms have been used to the system that may require attention. and is known to mobilize pathogens predict the presence of pathogens in For example, regular testing results may from sediment reservoirs to the water water, with varying degrees of success. show that periodic increases in column (Ref. 117. Ref. 120. Ref. 121. These include total coliforms, fecal indicator organisms are correlated with Ref. 122. Ref. 123) as well as carry coliforms, enterococci, generic E. coli,

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and coliphages. However, their presence 124) and there is ample evidence that indicator of fecal contamination, does not always signal the presence of they can grow and multiply there (Ref. pathogens are not always present in that pathogens and the absence in their 132. Ref. 133. Ref. 114. Ref. 123). This fecal material because their distribution detection is not assurance that makes using fecal coliforms as and persistence is sporadic. As a pathogens are absent (Ref. 126. Ref. 127. indicators for fecal contamination consequence, the record of generic E. Ref. 128. Ref. 129. Ref. 130). problematic, as it would be difficult to coli as a predictor of pathogens is Consequently, Gerba (2009) (Ref. 120) separate increases in their numbers due mixed. The Canadian Federal- suggested indicators be defined by a to natural forces (e.g., precipitation, Provincial-Territorial Committee on purpose for which they are better suited erosion, wind, temperature) from Drinking Water states generic E. coli is instead as an indicator for pathogens. increases due to fecal contamination unsatisfactory in predicting the For example, efficacy of treatment (e.g., events. presence of Giardia, Cryptosporidium, public water systems) or integrity in Generic E. coli is a member of both and enteric viruses (Ref. 119. Ref. 124) manufacturing processes (e.g., bottled the coliform and fecal coliform groups and Horman et al. 2004 (Ref. 131) found water) can be effectively monitored by but has been shown to more poor correlation between generic E. coli total coliforms because these consistently be associated with fecal and the presence of pathogens environmental bacteria are not expected contamination than other indicators (Campylobacter spp., Giardia spp., to survive the treatment conditions or be (Ref. 134. Ref. 135. Ref. 133. Ref. 136. Cryptosporidium spp., and noroviruses) introduced during the manufacturing Ref. 137. Ref. 138. Ref. 112). It can be in Finnish surface waters. However, process. Their presence in treated found in at least 90 percent of all human they did conclude that the absence of municipal water or in bottled water may and animal feces (Ref. 108) (Ref. 116) generic E. coli was a very strong signal an inadequate treatment or where it persists, more than other predictor for the absence of pathogens. deficient manufacturing step meriting transient fecal coliforms (Ref. 125. Ref. Duris et al (2009) (Ref. 132) found investigation and subsequent corrective 124). While its association with fecal generic E. coli inconsistently correlated action to resolve the problems contamination is very strong, it has also to genetic markers for generic E. coli identified. Another example is using been isolated from environments with O157 in Michigan and Indiana river fecal indicator bacteria (e.g., enterococci no apparent fecal contamination, water but suggested the relationship or generic E. coli) to assess the risk of including tropical watersheds (Ref. 126) could be strengthened by increased gastrointestinal illness (or other adverse and paper mill effluents (Ref. 127). sample size. Alternately, Wilkes et al., health conditions) in marine and Outside of these findings, reports of 2009 (Ref. 133) reported generic E. coli freshwater swimmers, because their generic E. coli growth and proliferation concentrations were the best indicator presence is statistically correlated to outside the gut (e.g., in water) are of pathogens (E. coli O157:H7, adverse health outcomes in these groups generally rare. Generic E. coli Salmonella spp., Campylobacter spp, (Ref. 119. Ref. 120). Generic E. coli demonstrates variable survival times in Giardia and Cryptosporidium) presence/ alone, as an easily distinguishable water but may only persist from 4 to 12 absence in Canadian watersheds. Others member of the fecal coliform group, is weeks at 15–18 degrees Celsius (Ref. have noted that generic E. coli has a more likely than the fecal coliform 116). better record as an indicator for group as a whole to indicate fecal Generic E. coli has an extensive Salmonella than for E. coli O157:H7 pollution (Ref. 120). Used in this way, history of use as an indicator of fecal (Ref. 134). Review of these studies indicator organisms are not used contamination and is considered the illustrates the complexity of possible specifically to predict the presence of best indicator for monitoring water interactions between indicators and pathogens, but are useful predictors of quality (Ref. 119). Its detection and pathogens in water, and their potential undesirable conditions (e.g., ineffective enumeration can be performed using a for separate fates within those systems. treatment, defective manufacturing variety of commercial products at Studies relating indicators, pathogens, process, presence of fecal material). relatively low cost. However, its ability and the risks associated with produce Total coliforms have frequently been to signal fecal contamination events is consumption are few and are used to assess water quality of several dependent upon sampling frequency complicated by the relationships different types of natural waters (e.g., and location relative to the source of described above. Different survival freshwater and marine) but their use for contamination. Thus, instances of non- profiles between indicators and this purpose has decreased recently as detection are not considered pathogens on produce may also affect they have been found to be present in confirmation of the absence of fecal risk. The World Heath Organization natural water both because of fecal contamination because sampling (Ref. 118) proposed a set of pathogen contamination and as natural frequency may not be adequate to detect reduction measures that can be used environmental inhabitants. They are events occurring over short periods of alone or in combination to achieve a 6– regularly isolated from soil, plants, time. Sampling results can only be 7 log pathogen reduction they vegetables, and effluents from considered snapshots of water quality determined necessary to meet health- agricultural and food industries but over time. Moreover, the fate and based targets. To verify the effectiveness their presence does not reliably signal a transport of generic E. coli in of the measures, they recommend fecal contamination event (Ref. 131. Ref. watersheds may be different than other monitoring generic E. coli levels in 112). Fecal coliforms share a similar fecal constituents in response to treatment effluents and in crops at problem. Fecal coliforms are coliforms localized conditions (e.g., sunlight, harvest. They noted that field pathogen that are capable of growth at higher temperature) (Ref. 128. Ref. 129. Ref. die-off is variable (0.5–2 log per day), temperatures, conditions similar to 130). dependent on temperature, sunlight, those which can be found in the One challenge in using indicator crop type, time, and other factors. mammalian gut. However, some of its organisms to predict water quality is Produce contamination events that members (e.g., Klebsiella, Citrobacter, correlating information concerning their occur during growing, harvesting, Enterobacter spp.) can normally be numbers to the presence or absence of packing, or holding on farm are found outside the intestine including pathogens (as compared to the presence generally thought to occur soil, water, vegetation, fresh vegetables, or absence of fecal material). Although intermittently and at low doses. As a silage, insects, and many others (Ref. generic E. coli is recognized as a good result, the detection of human

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pathogens in contaminated produce swimming in contaminated water may produce (Ref. 2). Therefore, in Section using available testing methodologies be different from those as a result of V.A.2.b (Definitions), we propose to remains an arduous process. It is eating produce irrigated with define ‘‘agricultural water’’ to mean impractical to test 100% of the product; contaminated water. The routes of water used in covered activities on therefore sampling plans to collect a infection and pathogen mortality rates covered produce, where water is statistically significant subset must be are different in each environment. intended to, or is likely to, contact devised. Unfortunately, although such Based upon a WHO analysis of covered produce or food-contact testing has in the past prevented some tolerable risk for irrigation water, the surfaces, including water used in contaminated product from entering the minimum microbial quality for water growing activities (including irrigation market when pathogens are found, it is used on root crops that are eaten raw is water applied using direct water also very possible that testing can 1,000 CFU generic E. coli per 100 ml application methods, water used for entirely miss a point contamination, (10,000 CFU generic E. coli per 100 ml preparing crop sprays, and water used thus it cannot provide a litmus test for in leaf crops) (Ref. 120. Ref. 118). for growing sprouts) and in harvesting, food safety because the sample size According to the WHO analysis, using packing, and holding activities needed to detect low dose, low water of this microbial quality is (including water used for washing or frequency, and non-uniformly dependent upon a 2 log reduction due cooling harvested produce and water distributed contamination is to die-off between last irrigation and used for preventing dehydration of impractically large (Ref. 135). In consumption (includes die-off in the covered produce). As we propose in addition, microbial testing can only field and during distribution) and a 1 § 112.3(c), ‘‘covered produce’’ refers to detect the pathogens the analytical log reduction attributed to washing the harvestable or harvested portion of procedures are designed to detect, and prior to consumption. This analysis the crop. As proposed, ‘‘agricultural we tend to only test for pathogens recognizes the variable nature of die-off water’’ does not include indirect water known to be of concern. Considering the values, ranging from 0.5–2.0 log per day application methods used during range of potential pathogens, these are (Ref. 118). The WHO analysis considers growing. For example, generally, the significant limitations. the need for a four log reduction water used for drip or furrow irrigation in apple orchards would not be b. Microbial Water Quality Standards through dilution, die-off, or treatment between the levels of generic E.coli in considered agricultural water because The lack of sufficient information to raw sewage (well represented in sewage the water is unlikely to contact the support a pathogen-based by fecal coliform levels) and the levels harvestable portion of the crop. As microbiological standard for water used in irrigation water used on root crops another example, generally, the water in the production of produce has led to that are eaten raw (3 log for leaf crops), used for overhead spray irrigation of the adoption of the generic E. coli in addition to the 3 log reduction romaine lettuce would be considered component of the U.S. EPA recreational discussed above. agricultural water because the water is water standards (for frequently used likely to contact the harvestable portion beaches) by some industry groups (Ref. 3. Proposed Requirements of the crop. We are proposing to 44. Ref. 31). The EPA recreational water a. General Requirement distinguish between water that is standards were developed from intended to, or is likely to, contact epidemiological studies that correlated Proposed § 112.41 would establish the covered produce or food-contact the risk of gastrointestinal illness to requirement that all agricultural water surfaces (e.g., direct water application exposure to marine and freshwater by must be safe and of adequate sanitary method irrigation water) and water that swimmers (Ref. 136). Generic E. coli was quality for its intended use. The is not intended to, or is not likely to, found to be a good predictor of principle of ‘‘safe and of adequate contact covered produce or food-contact swimming associated illness in sanitary quality for its intended use’’ surfaces based on the relative likelihood freshwater and the EPA recommended contains elements related both to the of contamination from water that criteria include a geometric mean of 126 quality of the source water used and the contacts covered produce and the need CFU per 100 ml and a single sample activity, practice, or use of the water. for measures to minimize such maximum for designated beach areas of Uses vary significantly, including: Crop likelihood. 235 CFU per 100 ml (Ref. 136). British irrigation (using various direct water If finalized as proposed, indirect Columbia, Canada has announced their application methods); crop protection water application methods would not be intention to use a similar approach in sprays; produce cooling water; dump subject to the requirements of this rule. setting generic E. coli criteria for tank water; water used to clean packing While indirectly applied water is irrigation water used on produce materials, equipment, tools and unlikely to contact produce or food- consumed raw. Their irrigation criteria buildings; and hand washing water. The contact surfaces, we recognize that it (less than or equal to 77 CFU per 100 way in which water is used for different presents the possibility of produce ml geometric mean) are the same as and commodities and agricultural practices contamination. For example, use of were derived from those used for can determine how effectively contaminated water in drip or furrow primary-contact recreation (Ref. 137). pathogens that may be present are irrigation may still serve as a vehicle for See section V.E. of this document for transmitted to produce. bringing contaminants into the growing additional discussion of this issue. Comparing the probability of environment which may potentially be The U.S. EPA criteria were developed contamination of covered produce transferred to produce by rain splash, from epidemiological studies of beach associated with key practices at workers, or equipment; use of areas subject to point source fecal different stages of production and across contaminated water for dust abatement contamination rather than non-point a range of commodities, the on farm roads may also be transferred to source contamination (e.g., birds, interrelatedness of these factors produce by run-off, rain splash, agricultural and livestock runoff). Non- becomes apparent. The QAR shows that workers, or equipment. point sources may also influence the the likelihood of contamination Indirect water application methods quality of agricultural water. Further, associated with indirect water use for would remain subject to Section adverse health outcomes as a irrigation is relatively low compared to 402(a)(4) of the FD&C Act. That is, consequence of immersion while irrigation water that directly contacts indirect water application may

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adulterate produce if, considering the which of the proposed requirements for containing elevated generic E. coli used water quality and the manner of its agricultural water described in section in overhead irrigation shortly before application, the use of the water causes V.E. of this document would (or would harvest may increase the likelihood of produce to be prepared, packed, or held not) be appropriate for indirect water covered produce being contaminated under insanitary conditions whereby it use? Are there other factors that we with the pathogen at harvest, but the may have been contaminated with filth should consider? In every application of same water could safely be used to or rendered injurious to health. water, careful consideration should be establish a crop and throughout the Moreover, if a pathogen is detected in or given to what you know about the majority of the growing season because, on produce, such produce would be water’s quality at its source, the impact as discussed in the QAR, pathogens die- considered adulterated under Sections your distribution system may have on off over time on the surface of produce. 402(a)(1) of the FD&C Act, in that it the water quality, and when or how that Water used for washing hands during contains a poisonous or deleterious water is to be used. For example, water and after harvest, sprout irrigation, substance which may render it injurious that contains Salmonella would not be directly contacting produce during or to health. Therefore, we tentatively safe or of adequate sanitary quality for after harvest (such as in washing and conclude that indirect water application its intended use when used in a cooling, or to make ice that directly methods do not need to be covered postharvest dump tank for tomatoes. contacts produce), making treated within the scope of ‘‘agricultural water’’ Salmonella is a food safety hazard that agricultural tea, and water or ice that for the purposes of this rule. is well-documented to present a risk of will contact food contact surfaces that We ask for comment on the limited severe adverse health consequences or contact covered produce presents an scope of ‘‘agricultural water’’ to only death, and tomatoes can become even greater likelihood of microbial water that is intended to, or likely to contaminated by water containing contamination of covered produce (Ref. contact covered produce or food-contact Salmonella (Ref. 138. Ref. 139. Ref. 131. Ref. 132). Waterborne pathogens surfaces. We also seek comment on its 140). As another example, when the can be transferred to covered produce resulting effect on the applicability of surface water (e.g., river) that you use with little opportunity for die-off if the general requirement in proposed for crop irrigation using a direct contaminated water is used for hand § 112.41 that agricultural water must be application method has a noticeable washing during or after harvest, or in safe and of adequate sanitary quality for decrease in quality due to an upstream harvest, packing or holding activities its intended use, to only water that is event like the failure of a waste water where it directly contacts produce or intended to, or likely to, contact covered treatment plant, resulting in the surfaces that contact produce and, produce or food-contact surfaces. Water accidental discharge of untreated therefore, it is important to ensure that that is not safe or of adequate sanitary municipal sewage into the river, your the water is safe and of adequate quality for its intended use may lead to water source would not be safe or of sanitary quality for such uses. Moreover, contamination of covered produce, even adequate sanitary quality for its the high nutrient, high moisture where the water use is indirect. We have intended use until the discharge is over conditions inherent to sprout previously recommended measures and the water has been tested because production and agricultural teas not such as indirect water use when water the incompletely treated sewage in the only support pathogen survival but are quality is poor or unknown as a measure discharge is likely to contain pathogenic also conducive to their amplification if to minimize risk (Ref GAPs Guide). microorganisms that could compromise present (Ref. 142. Ref. 16). Again, the Considering the FD&C Act would still the safety of irrigated covered produce. selection of a water source for these uses apply to such uses, and that there is a must ensure that the water is safe and lower likelihood of contamination of The most frequently used irrigation of adequate sanitary quality for that use. produce by indirect water use, is there methods include overhead, surface and a need to subject indirect water use, subsurface drip, furrow, flood, and seep b. Measures Regarding Agricultural including water used for dust irrigation (Ref. 29). These practices may Water Sources and Distribution Systems abatement, to the general requirement in be commodity-specific and choices may Proposed § 112.42 would establish the proposed § 112.41? We welcome be limited by the availability of different measures that you must take with comment on this approach, as well as water sources, crop needs, climate, respect to agricultural water sources, other actions that have been found to be precipitation levels, or regional water distribution systems, and pooling effective through practice and practices. Each irrigation method of water. experience. presents a different likelihood of We also considered proposing some contamination, independent of the Proposed § 112.42(a) would establish requirements for water that is used water source and its application to a that at the beginning of a growing during growing, but which does not particular commodity. For example, the season, you must inspect the entire contact the harvestable portion of likelihood of produce contamination agricultural water system under your covered produce. For example, water may be reduced if irrigation water is control (including water source, water that did not contact produce would not delivered by subsurface drip irrigation distribution system, facilities, and have been subject to any testing compared to using the same water to equipment), to identify conditions that requirement, although we considered irrigate by overhead spray (Ref. 141. Ref. are reasonably likely to introduce requiring this water and all agricultural 122). Researchers also concluded that known or reasonably foreseeable water to be of safe and adequate sanitary both the physical properties of the hazards into or onto covered produce or quality for its intended use (proposed edible portion of the crop, such as food-contact surfaces in light of your § 112.41). We also considered requiring surface texture, and the location of the covered produce, practices, and indirect water to comply with proposed edible portion of the plant in relation to conditions, including consideration of § 112.42(a) (sanitary survey) and irrigation water played significant roles the following: § 112.42(b) through (d) (adequately in contamination (Ref. 130). As (1) The nature of each agricultural maintaining water sources under your discussed in the QAR, the timing of water source (for example, ground water control). If we did include both direct irrigation water application also plays a or surface water); and indirect water use in the definition role in minimizing the persistence of (2) The extent of your control over of ‘‘agricultural water’’ in the final rule, contamination. For example, water each agricultural water source;

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(3) The degree of protection of each Act and are therefore not subject to EPA those nearby uses of which you are agricultural water source; regulation. Thus, water quality and aware will help you determine (4) Use of adjacent or nearby land; survey data on ground water used for appropriate and safe use of that water and agriculture are not publicly available. source. (5) The likelihood of introduction of By their nature, surface waters are open Proposed § 112.42(a)(5) requires you known or reasonably foreseeable systems, subject to the influence of to consider the likelihood of hazards to agricultural water by another various environmental factors that can introduction of known or reasonably user of agricultural water before the impact the safety of the water. For foreseeable hazards to agricultural water water reaches your covered farm. example, increased precipitation levels, by another user of agricultural water Human pathogens can enter an storm events, or wind may result in a before the water reaches your covered agricultural water system anywhere spike in water turbidity, due to farm. For example, if you use water from its source to point of use. Central redistribution of sediments. We from a river and are downstream from to the prevention of pathogen tentatively conclude that there exists a waste water treatment plant that contamination of agricultural water is significant potential for contamination discharges into that river, this provision an inspection of water source and the of ground and surface waters and, would require you to consider the components of the distribution system therefore, we propose to require you to likelihood that the wastewater treatment to identify potential routes of include both ground and surface water plant introduces hazards into the water contamination. Inspections of water sources in your inspection of your before it reaches your farm. For sources and components of its agricultural water systems. We seek example, you would consider the distribution system are recommended comment on this tentative conclusion likelihood of accidental discharge of by government and industry references and associated proposals. untreated municipal sewage into the (Ref. 10. Ref. 20. Ref. 45. Ref. 44). Proposed § 112.42(a)(2) requires you river. Generally, inspection of the to consider the extent to which you Proposed § 112.42(b) would require agricultural water system under your have control over your agricultural that you adequately maintain all control beginning at the water system water source to identify conditions that agricultural water sources that are under source is the first opportunity for are reasonably likely to introduce your control (such as wells) by regularly ensuring that it will deliver water that known or reasonably foreseeable inspecting each source and keeping the is safe and of adequate sanitary quality hazards into or onto covered produce or source free debris, trash, domesticated for its intended use. Inspection of your food-contact surfaces. You may have animals, and other possible sources of water source provides an opportunity to more control over your ground water contamination of covered produce to the identify and characterize activities and source (well) if it draws water from an extent practicable and appropriate situations that may lead to aquifer beneath your property and under the circumstances. Regular contamination of your agricultural which you protect from the influence of maintenance of your water sources is water. Further, inspection results surface activities. You would likely imperative to ensure the continued provide you with historical knowledge have less control if your well is located safety of your water. Maintenance of on- of your water sources, their quality, and near a concentrated animal feeding farm water sources may include upkeep factors that may affect their quality (Ref. operation or is influenced by surface and repair of berms, pipes, liners, or any 31). Inspection of the water source and water (e.g., a shallow well). You may structural elements, that are used to any equipment used to obtain the water have greater access to and control of on- protect the source. Properly maintaining from the source (e.g., well head, pumps, farm surface water sources such as a well includes conducting wellhead pipes) can ensure that the water that impoundments, catches, and ponds, inspections, during which time you enters the distribution system is suitable than you would for flowing surface check the condition of the well for its intended use. waters that only course through but do covering, casing, and cap to make sure Proposed § 112.42(a)(1) requires you not originate on your land. all are in good repair, leaving no cracks to consider the nature of your Proposed § 112.42(a)(3) requires you or other entry points for potential agricultural water sources to identify to consider the degree of protection of contaminants. Properly maintaining a conditions that are reasonably likely to each agricultural water source. storage tank includes cleaning the introduce known or reasonably Examples of protection for water interior surfaces of all rust scale, paint foreseeable hazards into or onto covered sources include covers, containments, scale, dirt, and bio-film forming growths produce or food-contact surfaces. As or fencing that exclude domesticated and inspecting exterior surfaces for discussed in the QAR, ground water animals or other possible sources of corrosion which may become a route of which is often believed to be pathogen contamination from the water source or contamination (Ref. 31). Properly free can be contaminated. Ground water earthen berms or other barriers that help maintaining a farm pond that is used for can also be compromised and its water minimize the influence of runoff on the irrigation using a direct application quality degraded if wells are improperly water source. method, with respect to keeping it free constructed, poorly maintained, or Proposed § 112.42(a)(4) requires you from domesticated animals, could mean improperly located (e.g., near areas of to consider the use of adjacent or nearby fencing the pond if you keep extensive livestock production or fields land. Agricultural water may be affected domesticated animals in the area such where manure is applied (Ref. 143. Ref. by upstream agricultural practices and that they would otherwise have access 144. Ref. 122). U.S. water systems using runoff from those operations into to the pond. On the other hand, if you ground water as source waters for surface water sources that you use. For treat the water before use in this way, drinking must operate in compliance example, an upstream alfalfa grower you may not need to take steps to with the U.S. EPA Ground water Rule may apply raw manure as a soil prevent access of the domesticated (GWR) (40 CFR parts 141 and 142) to amendment, and irrigation water runoff animals to the pond. This proposed protect against illness from waterborne from that field may flow into your provision should not be construed to pathogens in ground water. However, agricultural surface water source. While require the ‘‘taking’’ of an endangered the GWR does not address private wells you may have little or no control of species, as the term is defined in the because they are not under the other agricultural water user practices, Endangered Species Act (16 U.S.C. jurisdiction of the Safe Drinking Water this proposed requirement to consider 1532(19)) (i.e., to harass, harm, pursue,

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hunt, shoot, wound, kill, trap, capture, agricultural water is used for washing separate the pooled water from the or collect, or to attempt to engage in any produce as described in proposed covered produce. We acknowledge the such conduct). § 112.44(a). Similarly, your water would potential for small pools of water to Proposed § 112.42(c) would require not be considered safe or of adequate temporarily form in field areas or at the that you adequately maintain all sanitary quality if you found that test base of plants after irrigation. Small agricultural water distribution systems results exceeded 235 CFU per 100 ml amounts of water of this nature, which as necessary and appropriate to prevent generic E. coli in a water sample you are temporary and occur in the normal the water distribution system from being obtained from water used to overhead course of irrigation practices, are not a source of contamination to covered irrigate lettuce (a direct application reasonably likely to contribute to the produce, food-contact surfaces, areas method) as provided in proposed contamination of covered produce. We used for a covered activity, or water § 112.44(c). We seek comment on these are not suggesting that it will always be sources, including by regularly proposed thresholds. possible to eliminate pooling. Avoiding inspecting and adequately storing all Under this proposed provision in pooling by careful control of irrigation equipment used in the system. Regular § 112.42(d)(1), for example, you would is ideal; however, events such as rainfall maintenance of your agricultural water review your previous inspection results or irrigation malfunction may distribution system can be performed in for the affected portion of your sometimes make pooling inevitable. In conjunction with inspections and agricultural water system and compare those cases, the proposed requirement cleaning, as applicable. If not regularly those results to conditions you currently would require farms to take steps to maintained, portions of a water observe. You would identify changes protect covered produce from distribution system may fail, corrode, likely to have an impact on the quality contamination that may build in the collect debris, or otherwise become a of water (e.g., evidence of runoff, animal pooled water. source of contamination. For intrusion, suspended sedimentation, agricultural water distribution system changes in adjacent land use) or any c. Requirements for Treating components that are underground, it lapses in your procedures (e.g., outdated Agricultural Water would be important to look for signs of well inspection, break in the water Water treatment is an effective means erosion or wet soil areas, as they may treatment schedule). You would test the of decreasing the number of waterborne indicate a damaged underground water after you make changes you find outbreaks in sources of drinking water component requiring further inspection necessary during your inspection. (Ref. 146). However, treatments that are and maintenance (Ref. 145). Under the proposed provision in inadequate or improperly applied, Proposed § 112.42(d) would establish § 112.42(d)(2), you could instead choose interrupted, or intermittent have been that you must immediately discontinue to treat your water in accordance with associated with waterborne disease use of a source of agricultural water the requirements of § 112.43 to ensure outbreaks (Ref. 146). Failures in and/or its distribution system, and not its safety. We tentatively conclude that treatment systems are largely attributed use the water source and/or its the measures proposed in § 112.42(d) to suboptimal particle removal and distribution system when you have are necessary and adequate to address treatment malfunction (Ref. 147). For determined or have reason to believe deficiencies that may exist in your water this reason, when treating water, it is that your agricultural water is not safe management system and practices so important to monitor the treatment and of adequate sanitary quality for its that your agricultural water does not parameters to ensure the treatment is intended use, until you either: (1) Re- serve as a source of contamination to delivered in an efficacious manner. inspect the entire agricultural water covered produce. We welcome comment Monitoring treatment can be performed system under your control, identify any on this approach, as well as other in lieu of microbial water quality conditions that are reasonably likely to actions that have been found to be monitoring, if under the intended introduce known or reasonably effective through practice and conditions of the treatment, the water is foreseeable hazards into or onto covered experience. rendered safe and of adequate sanitary produce or food-contact surfaces, make Proposed § 112.42(e) would establish quality for its intended use. Many necessary changes, and test the water to that, as necessary and appropriate, you operations choose to perform microbial determine if your changes were effective must implement measures reasonably water quality testing in addition to and to ensure that your agricultural necessary to reduce the potential for monitoring the water treatment as a water is safe and of adequate sanitary contamination of covered produce with further assurance of treatment quality for its intended use; or (2) treat known or reasonably foreseeable effectiveness (Ref. 148). the water in accordance with the hazards as a result of pooling of water. Proposed § 112.43 would establish requirements of § 112.43. Using For example, such measures may requirements related to treatment of agricultural water that is not safe or of include using protective barriers or agricultural water. Specifically, adequate sanitary quality for its staking to keep covered produce from proposed § 112.43(a) would require that intended use may lead to contamination touching the ground, or using an you must treat any agricultural water of covered produce. Lapses in sanitary alternative irrigation method. Pooling that you use (such as with an EPA- quality of water can occur in any may occur if excessive water is applied registered antimicrobial pesticide segment of a water system, from source to a crop, especially in areas of poor product) if you know or have reason to to point of use. For example, if you find drainage. Pooled water that remains for believe that the water is not safe and of that water contains Salmonella at the extended periods of time has been adequate sanitary quality for its point where it would be used in a dump shown to increase likelihood of intended use, whereas proposed tank for tomatoes, it would not be safe contamination (Ref. 10. Ref. 45). § 112.43(b) would require that any or of adequate sanitary quality for that Further, if pooled water is in close method you use to treat agricultural intended use. As another example, your proximity to the crop, it may serve as an water to satisfy this requirement in water would not be considered safe or attractant for pests. Mounding soil, paragraph § 112.43(a) must be effective of adequate sanitary quality for its staking, subsoil drip irrigation, drip tape to make the water safe and of adequate intended use if you found detectable or plasticulture (use of agricultural sanitary quality for its intended use. In generic E. coli in a 100 ml water sample plastics) are methods that are used to addition, proposed § 112.43(c) would you obtained at the point where the reduce the potential for pooling or to require you to: (1) Deliver any treatment

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of agricultural water required by done in real-time and in an inexpensive, water source and/or distribution system § 112.43(a) in a manner to ensure that automated manner, facilitating good again for the uses described in the treated water is consistently safe and control of the process (Ref. 149). As a § 112.44(a), you must either re-inspect of adequate sanitary quality for its verification that the treatment process, the entire agricultural water system intended use; and (2) monitor any monitored in accordance with the under your control, identify any treatment of agricultural water at a proposed requirements of § 112.43(c)(2), conditions that are reasonably likely to frequency adequate to ensure that the is effective in achieving a certain introduce known or reasonably treated water is consistently safe and of microbial standard (e.g., no detectable foreseeable hazards into or onto covered adequate sanitary quality for its generic E. coli in 100 ml of water), you produce or food-contact surfaces, make intended use. may chose to perform periodic necessary changes, and retest the water If you choose to use water that is not microbiological analysis of the treated to determine if your changes were safe or of adequate sanitary quality for agricultural water. We are not proposing effective and to ensure that the water its intended use, the water must be at this time that treated water must be meets the requirements of § 112.44(a); or treated before it is put to such use to tested in this manner because we treat the water in accordance with the minimize the likelihood for believe that the effectiveness of various requirements of § 112.43. contamination. For example, treating treatment processes is well understood. We reviewed the most widely used agricultural water with antimicrobial However, we encourage farms to indicator(s) or indicator groups for their compounds can be an effective means to perform such testing to provide further potential in assessing the microbial eliminate pathogens if done properly, assurance of the effectiveness of their quality of water used for purposes including under conditions that ensure treatment under the specific conditions described in proposed § 112.44(a) and the effectiveness of the active ingredient that exist on their farm. We seek all other uses of agricultural water as (Ref. 149. Ref. 150). Any chemicals used comment on this issue. described in section V.E.2 of this in the treatment of water would require document. We considered total EPA registration under the Federal d. Testing and Frequency of Testing of coliforms and fecal coliforms as Insecticide, Fungicide and Rodenticide Agricultural Water indicators of fecal contamination but Act before they can be lawfully used. Proposed § 112.44 would establish determined that neither of them can We note, however, that at the present requirements related to testing of serve as reliable indicators of a fecal time, no such registration for chemical agricultural water and subsequent contamination event (Ref. 124. Ref. 119. treatment of irrigation water exists. We actions based on the test results. Ref. 151. Ref. 152). Generic E. coli is a anticipate that the proposed delayed Specifically, proposed § 112.44(a) member of both the coliform and fecal implementation period for water quality would require that you test the quality testing (see section IV.K. of the coliform groups but, unlike some of agricultural water according to the members of those groups, it has been document) would provide industry requirements in § 112.45 using a adequate time to address such issues. shown using various detection methods quantitative, or presence-absence to be the only coliform consistently We seek comment on this issue. method of analysis provided in subpart To ensure water treatment is associated with fecal contamination N to ensure there is no detectable (Ref. 132. Ref. 133. Ref. 134. Ref. 135. delivered in an effective manner, generic E. coli in 100 ml agricultural monitoring the conditions of treatment Ref. 136. Ref. 137. Ref. 108). Generic E. water when it is: coli has an extensive history and is also essential. An effective monitoring (1) Used as sprout irrigation water; program would measure the level of (2) Applied in any manner that support for use as an indicator of fecal active compound as well as those directly contacts covered produce contamination. Recently, it has emerged factors that may affect its activity, such during or after harvest activities (for as the preferred indicator for monitoring as pH, temperature, and contact time. example, water that is applied to water quality, not only because of the For example, monitoring water treated covered produce for washing or cooling problems with other groups noted with hypochlorite in an orange activities, and water that is applied to above, but also due to the development postharvest wash would include, at a harvested crops to prevent dehydration of superior methods of detection with minimum, monitoring the level of active before cooling), including when used to greater accuracy, sensitivity, and antimicrobial (free available chlorine) make ice that directly contacts covered simplicity over those previously used and pH, since it is known that produce during or after harvest (Ref. 119). Despite widespread use and hypochlorite activity is reduced both by activities; support for generic E. coli as an organic material (e.g., soil, plant debris) (3) Used to make a treated agricultural indicator of fecal contamination, its and pH values outside its effective range tea; ability to signal contamination events is (pH 6.0–7.5) (Ref. 149. Ref. 150). The (4) Used to contact food-contact not without challenges. Sampling concentration of active disinfectant and surfaces, or to make ice that will contact frequency and location relative to the pH must be adjusted, as necessary, food-contact surfaces; or source of contamination are reported to taking into account variations in water (5) Used for washing hands during affect the performance of generic E. coli quality in order to maintain the and after harvest activities. as an indicator of fecal contamination effectiveness of the treatment. In We seek comment on the (Ref. 133. Ref. 143. Ref. 153. Ref. 131). addition, the frequency in which you appropriateness of these proposed Thus, non-detection cannot be monitor agricultural water treatment categories in which testing would be considered absolute confirmation that must be adequate to ensure that the required. fecal contamination has not occurred. conditions for proper treatment are Proposed § 112.44(b) would require Further, the fate and transport of generic consistently met and adjusted, as that if you find that there is any E. coli takes different paths in different necessary, to result in water that is safe detectable generic E. coli in 100 ml of watersheds, and reservoirs have been and adequate for its intended use. water, you must immediately identified, particularly sediments, Research has shown that in other discontinue use of that source of where they may escape detection in the settings, monitoring of physical agricultural water and/or its distribution water column (Ref. 128. Ref. 129. Ref. parameters, such as temperature, pH system for the uses described in 130. Ref. 154). Nevertheless, based on and disinfectant concentration, can be § 112.44(a). Before you may use the our review of the literature, we

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tentatively conclude that generic E. coli 1928.110(b), a hand-washing facility generic E. coli per 100 mL of serves as the most appropriate microbial means ‘‘a facility providing either a agricultural water used in these indicator of fecal contamination of basin, container, or outlet with an activities and practices would be water at this time and, therefore, we adequate supply of potable water, soap consistent with EPA’s MCLs for propose to use a microbial standard of and single-use towels;’’ and potable microbiological contaminants in public no detectable generic E. coli in 100 ml water means ‘‘water that meets the drinking water systems (40 CFR agricultural water when it is for the standards for drinking purposes of the 141.63(b)) and with our standard of intended uses listed in § 112.44(a). We State or local authority having quality for bottled water (21 CFR seek comment on our selection of this jurisdiction, or water that meets the 165.110(b)(2)(B)). We request comment indicator. quality standards prescribed by the U.S. on the need for, and appropriateness of, As discussed in the QAR, water used EPA’s National Primary Drinking Water this proposed requirement and any for the purposes listed in proposed Regulations [NPDWR] (40 CFR part other criteria that would ensure the § 112.44(a) has the potential to serve as 141).’’ The OSHA requirements in 29 safety of water for these intended uses. a vehicle of pathogen contamination by CFR 1928.110 require that farms We tentatively conclude that we direct contact with covered produce. employing eleven or more employees should require that if the water you use Water used in sprout production must engaged in hand-labor operations in the for the purposes listed in § 112.44(a) be free of fecal contamination because field for a period of more than three does not meet the microbial standard of no detectible generic E. coli per 100 ml, the conditions under which sprouted hours in a day provide water that you must immediately discontinue use seeds are produced (warm, moist, satisfies the microbial maximum of the water and/or distribution system nutrient-rich environment for extended contaminant level (MCL) in the for those purposes. Before you use the period of time) are conducive to NPDWR, which states that any generic water source and/or distribution system pathogen multiplication (Ref. 14). As E. coli-positive repeat sample or generic again for those uses, you would need to discussed in section I.A. of this E. coli-positive routine sample (which either (1) re-inspect the entire document, outbreaks associated with would include a finding of any agricultural water system under your sprouted seeds are well documented; detectable generic E. coli in 100 ml of control, identify any conditions that are Salmonella and E. coli O157:H7 have water using the methods of analysis in reasonably likely to introduce known or been the major causes of sprout- proposed subpart N) constitutes a violation of the MCL for total coliforms. reasonably foreseeable hazards into or associated outbreaks (Ref. 14). Similarly, onto covered produce or food-contact the conditions under which agricultural Therefore, the microbial standard for hand washing water during harvesting, surfaces, make necessary changes, and tea is produced (moist and nutrient- retest the water to determine if your rich) are similar in that they support the packing, and holding activities that is specified in proposed § 112.44(a) would changes were effective and to ensure multiplication of pathogens, if present that the water meets the required (Ref. 142). Even a low number of be consistent with the OSHA requirements. microbial standard; or (2) treat the water pathogens introduced into or onto in accordance with the requirements of covered produce through contaminated We acknowledge the difficulty of § 112.43 (proposed § 112.44(b)). This water could rapidly increase to levels associating specific indicator proposed requirement is parallel to the that could present risk of serious concentrations with specific produce requirement in proposed § 112.42(d), adverse health consequences or death to related health risks. Even so, we have which is discussed above. those who consume the covered tentatively concluded that such Proposed § 112.44(c) would require produce for which the tea was used. difficulty does not negate the value of that when agricultural water is used Further, water that is used in direct applying generic E. coli test results to during growing activities for covered contact with produce or food contact the requirement to discontinue use of a produce (other than sprouts) using a surfaces, or in making ice that directly water source until compliance with direct water application method, you contacts produce or food contact applicable generic E. coli standard is must test the quality of water in surfaces, must also be free of fecal again achieved, because elevated accordance with one of the appropriate contamination and pathogens. These indicator organism concentrations analytical methods in subpart N. If you water applications normally occur indicate increased levels of fecal find that there is more than 235 colony during or shortly after harvest, leaving contamination and elevated potential forming units (CFU) (or most probable only a relatively short period of time for the presence of human pathogens of number (MPN), as appropriate) generic before consumption for the fecal origin (Ref. 154). The uses listed in E. coli per 100 ml for any single sample environmental factors that drive proposed § 112.44(a) are similar in that, or a rolling geometric mean (n=5) of pathogen die-off to exercise a significant if pathogens or fecal contamination are more than 126 CFU (or MPN, as effect (see the QAR). In addition, we present, it is reasonably likely they appropriate) per 100 ml of water, you propose to apply the microbial standard could be transferred directly to covered must immediately discontinue use of in proposed § 112.44(a) to agricultural produce through direct or indirect (via that source of agricultural water and/or water that is intended for use in food-contact surfaces) contact with the its distribution system for the uses washing hands during harvesting, water. Therefore, testing the agricultural described in § 112.44(c). Before you may packing, and holding activities, where water used for these purposes to ensure use the water source and/or distribution there is little opportunity for microbial that it is absent of generic E. coli would system again for the uses described in die-off prior to consumption. Hands that provide reasonable assurances that the § 112.44(c), you must either re-inspect contact produce during and after harvest water does not contain pathogens, and the entire agricultural water system must be free of microbial contaminants therefore that the water is not likely to under your control, identify any (Ref. 133). In the United States, the introduce pathogens into or onto conditions that are reasonably likely to Occupational Safety and Health covered produce and to provide introduce known or reasonably Administration (OSHA) of the U.S. reasonable assurances that the produce foreseeable hazards into or onto covered Department of Labor has established will not be adulterated under section produce or food-contact surfaces, make requirements for water used for washing 402 of the FD&C Act. Moreover, a necessary changes, and retest the water workers’ hands. Under 29 CFR requirement that there be no detectable to determine if your changes were

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effective; or treat the water in warranted. Wade et al (2003) (Ref. 155) standards; soil, plants, and produce for accordance with the requirements of performed a systematic review of 27 this proposed rule). § 112.43. We seek comment on this studies of water quality indicators used We also acknowledge that the approach. for the regulation of recreational waters. proposed standard is more stringent As discussed in section V.E.2 of this They compared the ability of than the WHO standard. Based upon an document, the WHO recommends enterococci, fecal coliform, generic E. analysis of tolerable risk for irrigation monitoring generic E. coli numbers in coli and total coliform levels to predict water, WHO recommends that the treatment effluents as verification of for the occurrence of gastrointestinal minimum microbial quality for water wastewater treatment, and laboratory illness. They concluded that for used on root crops that are eaten raw is analysis of crop contamination levels freshwater, generic E. coli was the more 1000 CFU generic E. coli per 100 ml with generic E. coli at harvest and in consistent predictor. Working under the (10,000 CFU generic E. coli per 100 ml retail to verify pathogen mortality (die- framework of a WHO project for setting in leaf crops) (Ref. 118. Ref. 120). off) (Ref. 118). However, they also noted guidelines for quality of recreational According to the WHO analysis, using the variability in pathogen die-off (0.5– waters and bathing beaches, Pruss water of this microbial quality is 2 log/day), dependent on temperature, (1998) (Ref. 156) reviewed 22 studies on dependent upon a 2 log reduction due sunlight intensity, crop type, time of uncontrolled waters (seas, lakes, and to die-off between last irrigation and water application, and other factors. rivers) for dose-related relationships consumption (includes die-off in the Some industry groups have adopted between GI illness and bacterial field and during distribution) and a 1 the generic E. coli component of the indicator (most commonly generic E. log reduction attributed to washing U.S. EPA recreational water standards coli, enterococci, and fecal coliforms) prior to consumption. This analysis (for beaches used frequently) for certain counts. The author found the two recognizes the variable nature of die-off uses of agricultural water (Ref. 31. Ref. indicator organisms which correlate best values, ranging from 0.5–2.0 log per day 44). In this regard, EPA recommends with health outcomes were enterococci (Ref. 118). The WHO analysis considers that criteria include a maximum steady for both marine and freshwater and the need for a four log reduction state geometric mean of 126 CFU of generic E. coli for freshwater. through dilution, die-off, or treatment generic E. coli per 100 ml and a single We considered proposing a drinking between the levels of generic E.coli in sample maximum allowable density of water standard for water used on raw sewage (well represented in sewage 235 CFU of generic E. coli per 100 ml covered produce other than sprouts by fecal coliform levels) and the levels (Ref. 136). British Columbia, Canada has in irrigation water used on root crops during growing in a direct water announced their intention to use generic that are eaten raw (3 log for leaf crops), application method, but tentatively E. coli criteria for irrigation water used in addition to the 3 log reduction conclude that such criteria would be on produce consumed raw. Their discussed above. irrigation criteria (less than or equal to unnecessarily restrictive as it would not We tentatively conclude that the 77 CFU per 100 ml geometric mean) are sufficiently account for forces driving recreational water generic E. coli criteria the same as and were derived from pathogen die-off (e.g., sunlight, would serve to minimize risk of known those used for primary-contact competing microorganisms) (see section or reasonably foreseeable hazards when recreation (Ref. 137). Similarly, the V.E.2 of this document). We also used as a standard for agricultural water generic E. coli component of EPA’s considered proposing a second lower used on produce other than sprouts recreational water standard (for beaches microbial quality criteria for water used during growing in a direct water used frequently) serves as the basis for in growing, but where the water used for application method. We recognize that our proposed standard for microbial irrigation is not reasonably likely to is somewhat more protective than the water quality for water used in direct contact the edible portion of the covered WHO standard, which we believe is application methods during growing produce (e.g., surface irrigation of tree appropriate given the uncertainty in die- (proposed § 112.44(c)). crops). However, we are not aware of off values. We request comment on the It should be noted that EPA’s another standard for which there is need for, and appropriateness of, this recreational water standards for beaches sufficient scientific support. requirement or other criteria that would used frequently also includes a We acknowledge that the EPA ensure the quality of agricultural water recommendation for a maximum steady recreational water standards were used for this purpose. state geometric mean of 33 CFU of developed from epidemiological studies We tentatively conclude that if enterococci per 100 ml and a single that correlated the risk of agricultural water you use on produce sample maximum allowable density of gastrointestinal illness to exposure to other than sprouts during growing in a 61 CFU of enterococci per 100 ml (Ref. marine and freshwater by swimmers direct application method does not meet 136). Similarly, the current British (Ref. 136), rather than to consumption of the microbial water quality described in Columbia criteria for irrigation water produce. These epidemiological studies § 112.44(c), you must immediately used on produce consumed raw is a were performed in beach areas subject discontinue use of that source of geometric mean of less than or equal to to point source fecal contamination agricultural water and/or its distribution 200 CFU fecal coliform per 100 ml and rather than non-point sources (e.g., system and either (1) re-inspect the they have announced their intention to birds, agricultural and livestock runoff), agricultural water system components use a geometric mean of less than or which may impact agricultural water. under your control, identify conditions equal to 20 CFU enterococci per 100 ml Further, risks of adverse health that are reasonably likely to introduce (along with generic E. coli, as discussed outcomes resulting from full body hazards to the system, make necessary above). We have tentatively concluded contact in contaminated water may be changes based upon your observations, to not include enterococci or fecal different than risks associated with and retest the water to determine if your coliform in our proposed standard at consuming produce irrigated with changes were effective; or (2) treat the § 112.44(c) because we believe generic contaminated water, given the water in accordance with the E. coli to be the superior indicator of differences in the expected routes of requirements of § 112.43. This proposed fresh water quality and do not believe infection and pathogen mortality rates requirement is parallel to the that the added cost of testing for both in the different environments (bodies of requirement proposed § 112.42(d), generic E. coli and enterococci is water for the EPA recreational water which is discussed above.

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We tentatively conclude that violation issues related to water quality testing. supply program, and you have Public of microbial water quality standards We seek comment on the adequacy of Water System results or certificates of proposed in §§ 112.44(a) and (c) in and this timeline. compliance that demonstrate that the of itself would not necessarily establish Proposed § 112.44(d) would also water meets that requirement; evidence of adulteration of covered allow you to establish and use (2) You receive water from a public produce subjected to use of the water, alternatives to the requirements water supply that furnishes water that nor would it necessarily mean that the established in proposed § 112.44(c) meets the microbial requirement food was contaminated. However, use of provided you satisfy the requirements of described in 112.44(a), and you have water that is shown to violate these proposed § 112.12. As discussed in public water system results or standards would violate the requirement section V.B. of this document, under certificates of compliance that at proposed § 112.41 that all agricultural proposed § 112.12(a)(1), you may demonstrate that the water meets that water must be safe and of adequate establish an alternative to the requirement; or sanitary quality for its intended use. As requirements, established in proposed (3) You treat water in accordance with described immediately above, these § 112.44(c) for testing water, and taking the requirements of § 112.43. proposed standards are based on action based on test results when Water testing frequencies likelihood of fecal contamination (as agricultural water is used during recommended by various industry indicated by the presence of generic E. growing operations for covered produce documents vary widely, in part because coli), that we have tentatively concluded (other than sprouts) using a direct water there is a lack of publicly available minimize the risk of serious adverse application method. We acknowledge information pertaining to the quality of health consequences or death by that in specific circumstances an irrigation waters. Recommendations preventing the introduction of hazards alternative standard (e.g., a standard range from monthly testing to once each and providing reasonable assurances that applies an application interval year, for sources with a history of that produce is not adulterated under (time between application and harvest) compliance with commodity specific section 402 of the FD&C Act. in place of the § 112.44(c) standard, but recommendations (Ref. 31. Ref. 44). Even for sources considered reliable Agricultural water in violation of these is specific to a specific commodity or (e.g., well water), a one year period standards indicates increased likelihood commodity group and region) may be between testing does not minimize the of fecal contamination of the water and, appropriate if the alternative standard is risk of known or reasonably foreseeable consequently, increased likelihood of shown to provide the same level of hazards because microbiological water produce contamination with human public health protection as the standard quality, even when sourced from ground pathogens, beyond that which is in proposed § 112.44(c) and not to water sources, is too variable for this appropriate for the intended use. increase the likelihood that the covered frequency of testing to be protective Therefore, we propose to require you to produce will be adulterated. Therefore, (e.g., effects of flooding, runoff) (Ref. immediately discontinue use of that we tentatively conclude that it would be 29). Alternatively, we tentatively source of agricultural water and/or its appropriate to allow for alternatives to the requirements in proposed conclude testing more frequently (less distribution system until you have than every 3 months) would not either followed certain prescribed steps § 112.44(c). We are working with USDA and other significantly improve the accuracy of to mitigate the problem or treated the stakeholders to facilitate research into your assessment of ground water quality water. application intervals that would be and would therefore be unnecessary. We Under the provisions of proposed commodity- and region-specific, such also considered proposing testing § 112.44, if covered farms choose to treat that water not meeting the proposed frequencies established as a function of irrigation water in accordance with the § 112.44(c) standard could be used in a commodity, irrigation method (e.g., requirements of proposed § 112.43, any direct water application method for furrow, seep, subsurface dripfoliar), and chemicals used in such treatment would growing covered produce other than timing of application (days prior to require registration under the Federal sprouts as long as it was applied before harvest), and concluded that the most Insecticide, Fungicide and Rodenticide the start of the scientifically established effective approach is to test on a Act before they can be lawfully used. At application interval (i.e., at a certain frequency related to the reliability of the the present time, no such registration for number of days before harvest or agricultural water sources. We chemical treatment of irrigation water earlier). tentatively conclude that requiring exists. As discussed in section IV.K. of Proposed § 112.45 would establish testing as a function of time before this document, FDA is proposing to requirements related to frequency of harvest would be impractical for many delay implementation of certain testing agricultural water that is subject farms as we have observed single provisions, including the water quality to the requirements of § 112.44. sources (e.g., a well) providing water for testing requirements in proposed Specifically, proposed § 112.45(a) multiple crops in different phases of § 112.44, beyond the effective dates for would require that you test any production. We request comment on other provisions of the rule. The agricultural water that is subject to the whether we should allow for adjustment proposed extended compliance dates for requirements of § 112.44 at the of ground water testing frequencies the water quality testing, monitoring, beginning of each growing season, and dependent upon historical test results. and related record keeping requirements every three months thereafter during the For example, we are considering in proposed §§ 112.44, 112.45, growing season, except that there would requiring testing ground water sources 112.50(b)(5), 112.50(b)(6), and be no requirement to test water when: every three months for one year and 112.50(b)(7) are six years from the (1) You receive water from a Public yearly after that if the ground water effective date for very small businesses, Water System, as defined under the Safe consistently met the standard. We also five years from the effective date for Drinking Water Act (SDWA) regulations, request public comments on our small businesses, and four years from 40 CFR Part 141, that furnishes water proposed approach to frequency of the effective date for all other farms that meets the microbial requirements testing, each of the options described subject to the rule. We expect these under those regulations or under the here, and any other alternative testing extended compliance dates to provide regulations of a State approved to frequencies that can be supported by adequate time for industry to address administer the SDWA public water water quality data.

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Proposed § 112.45(a)(1) provides an § 112.45(b)(2) would establish that if representation of the quality of water exception to testing required in you use untreated surface water for through the seasons. The sampling and § 112.45(a) when the water is sourced purposes that are subject to the testing frequencies proposed in from a Public Water System or State requirements of proposed § 112.44, and § 112.45(b) are the minimum that we authority approved to administer the if the untreated surface water is from tentatively conclude provide sufficient SDWA public water supply program, any source where underground aquifer information concerning your source and you have results of the water testing water is transferred to a surface water surface water quality for you to use in or certificates of compliance that containment constructed and determining method of application and demonstrate that the water meets the maintained in a manner that minimizes its timing for which the water is safe requirements of that program. These runoff drainage into the containment and of adequate sanitary quality. We systems operate so that the water they (for example, an on-farm man-made encourage additional sampling if you deliver meets the microbial requirement water reservoir), then you must test the have reason to believe that its quality in 112.44(a). In the U.S., Public Water water at least once each month during may have changed from the previous Systems are required under U.S. EPA the growing season. test. We welcome comments on the National Primary Drinking Water Surface water is subject to a great need for, and appropriateness of, our Regulations (NPDWR) in 40 CFR 141 to number of environmental factors that proposed testing frequencies, including provide safe, clean water suitable for may alter its microbial water quality as any alternative approaches and drinking and thus are at the lowest discussed in the QAR and, when examples where testing should be more likelihood for pathogen contamination. untreated, presents a significant source or less frequent based upon your Under the sampling, testing and of pathogen contamination of produce. experience or observation. The monitoring frequencies proposed reporting requirements of 40 CFR 141, We tentatively conclude that the most in this rule are practical intervals that we tentatively conclude that additional important among these is runoff, we tentatively conclude are reflective of actions by the grower to assure its safety because it has the potential to increase the varying potential for changes in are unwarranted. Similarly, proposed the number of pathogens in the water water quality between ground aquifers § 112.45(a)(2) provides for an exception column if its origins include human, and surface watersheds. In proposing to testing when the water is furnished livestock or wildlife feces and because the monitoring frequencies for untreated from a public water supply that it has the potential to increase the surface waters, we considered factors furnishes water that meets the standards amount of suspended sediments, which of § 112.44(a), and you have results of that are most likely to impact water are likely to harbor pathogens (Ref. 157. quality. Precipitation and its effects the water testing or certificates of Ref. 154). In proposing these testing compliance that demonstrate that the (e.g., discharge and flow rate) along with frequencies, we tentatively divided temperature are common factors water meets that standard. The standard untreated surface water into two in § 112.44(a) is derived from the EPA reported to affect the microbial quality categories based upon their potential to of watersheds with agricultural land drinking water standard, and this be impacted by runoff and the degree to provision is included to accommodate inputs (Ref. 159. Ref. 158). Precipitation which you reasonably could be levels have also been successfully used foreign public water supplies that are expected to exercise protection and not governed by the requirements of the to manage openings and closings of control over them. Flowing surface molluscan shellfish harvest areas. These EPA drinking water program, but waters (e.g., river, stream, or creek) or harvest areas are well characterized in provide water of a quality that meets the sources that are not protected against terms of changes in the microbial water microbial requirement of proposed runoff (e.g., natural ponds, lakes) must quality due to non-point source runoff § 112.44(a). Where public water that be tested at a relatively higher as a consequence of rainfall. However, meets or is comparable to (in other frequently than surface waters for which we have not proposed surface water countries) EPA’s drinking water you have direct control and which you testing frequency based upon standards is used in produce operations, can manage in a way so to minimize the precipitation because such an approach we are not aware of anything suggesting effect of runoff and other sources of would require full characterization of its a need for additional testing at its contamination (e.g., on-farm reservoir or effects (Ref. 143) on the quality of delivery point to the farm. We seek pond). Contamination events that can surface water sources that are not likely comments on this issue, including any lead to surface water contamination can to be generally useful across farms, practice(s) that could materially change have profound effects on the quality of States, or regions. Our approach to the quality of public or municipal water the water, but those effects can be testing untreated surface water is to between treatment and delivery to the fleeting, especially those involving propose practical intervals of testing farm, including changes in water quality runoff from rainfall (several days to both because they are likely to capture during water distribution and holding. several weeks). After the contamination transient events that may degrade Finally, § 112.45(a)(3) exempts from event passes, water quality generally quality and because they are useful testing water that you treat in returns to background levels (Ref. 158). regardless of geographic location. We accordance with proposed § 112.43, If sampling is less frequent than weekly welcome comments on this approach, which is discussed above. from surface water sources subject to including any alternate approaches, Proposed § 112.45(b)(1) would these kinds of contamination events, specifically if you believe that surface establish that if you use untreated there is a good chance that some waters can be thoroughly characterized surface water for purposes that are contamination events will go such that they require less frequent subject to the requirements of proposed undetected. On the other hand, for testing than proposed in § 112.45. § 112.44, and if the untreated surface surface water sources that are not water is from any source where a subject to significant runoff, the water e. Requirements for Water Used in significant quantity of runoff is likely to quality tends to remain stable, and the Harvesting, Packing, and Holding drain into the source (for example, a purpose of sampling is primarily to Activities river or natural lake), then you must test accurately characterize the background Proposed § 112.46 would establish the the water at least every 7 days during level. Monthly sampling provides 12 measures you must take for water that the growing season. Proposed samples per year that give a good you use during harvest, packing, and

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holding activities for covered produce. direct application method irrigation of mangos (Ref. 162). A recent study Specifically, proposed § 112.46(a) produce other than sprouts; or for water demonstrated that additional factors, would require that you manage the that does not meet the 235 CFU per 100 such as tomato variety and the time water as necessary, including by ml standard, applying the water for delay between tomato stem removal and establishing and following water-change irrigation in a different manner that is water immersion have a significant schedules for re-circulated water, to not a direct application method impact on the frequency and population maintain adequate sanitary quality and (§ 112.44). These provisions offer of internalized Salmonella in tomatoes. minimize the potential for flexibility for farms to choose among (Ref 140). However, this study also contamination of covered produce and different options to ensure that the demonstrated that Salmonella food-contact surfaces with known or water is safe and adequate for the internalization of tomatoes via their reasonably foreseeable hazards (for purpose for which it is intended. stem scar can occur even under a zero example, hazards that may be Should farms choose to disinfect water temperature differential, and ° introduced into the water from soil as a measure to control waterborne temperature differentials up to 10 F adhering to the covered produce). The hazards during handling during and have no effect on the internalization proposed language allows sufficient after harvest, we tentatively conclude frequency and have limited impact on flexibility for you to establish measures that an effective disinfection program Salmonella cell populations that are best suited to your needs based would render such water safe and of internalized in tomatoes. on practice and experience. For adequate sanitary quality. However, we We considered proposing a single example, you may establish a water- request public comment on the standard on temperature differential change schedule for water used in an appropriateness of this tentative between water and product core apple flume based upon the rate of conclusion and on whether a provision temperature (e.g., water must be at least product flow, organic load, or other specifically directed to disinfection of 10 degrees F warmer than core) but variables you determine best correlate water used during and after harvest is tentatively conclude that there is with safety and sanitary quality of the needed. We also seek public input insufficient scientific evidence flume water. Many commonly used regarding practices or conditions when supporting such a standard across all disinfection of re-circulated or single wash water antimicrobials have covered produce. However, we use water would be unnecessary, decreased efficacy when organic matter recognize the North American Tomato inappropriate, or impractical. Trade Work Group and California is present in the water. For example, Proposed § 112.46(b) would require organic matter builds up in agricultural Tomato Commission have that you visually monitor the quality of recommended such a standard (Ref. 44). water flume systems from dirt and water that you use during harvest, debris on the surface of fresh produce We seek public comment on the need packing, and holding activities for for, and appropriateness of, the that are placed into the flume systems. covered produce (for example, water Once the soluble and/or insoluble proposed provisions, including any used for washing covered produce in alternative approaches that you found to organic load builds up to sufficiently dump tanks, flumes, or wash tanks, and high levels, the addition of wash water be effective through experience or water used for cooling covered produce observation. antimicrobials becomes ineffective and in hydrocoolers) for build-up of organic inefficient. Changing the flume water on material (such as soil and plant debris). f. Records Requirements a regular basis, based on that system’s Organic matter such as soil and plant Proposed § 112.50 would establish unique operating conditions, can assure debris has to the potential to adversely requirements about the records that you that wash water disinfection treatments affect the quality of water; it may be a would need to establish and keep under are consistently effective (Ref. 149. Ref. source of bacteria (including pathogens), this proposed subpart E. Specifically, 150). We point out that while water support the growth of bacteria, and proposed § 112.50(a) would require that disinfection is one means to manage reduce the effectiveness of antimicrobial you establish and keep records required water quality, we are not specifically compounds (e.g., chlorine compounds) under this proposed subpart E in proposing to require disinfection (Ref. 150). Such monitoring allows you accordance with the requirements of treatment of re-circulated or single use to recognize conditions that require proposed subpart O. Proposed water that is used in harvesting, action, such as a water change in a § 112.50(b) would require that you packing, or holding activities. We are dump tank. establish and keep the following proposing that re-circulated or single Proposed § 112.46(c) would require records: pass water must be safe and of adequate that you maintain and monitor the (1) The findings of the inspection of sanitary quality for its intended use temperature of water at a temperature your agricultural water system in (§ 112.41) and that it contain no that is appropriate for the commodity accordance with the requirements of detectable E. coli (§ 112.44(a)). Further, and operation (considering the time and proposed § 112.42(a); if you have reason to believe that the depth of submersion) and is adequate to (2) Documentation of the results of water is not safe and of adequate minimize the potential for infiltration of any analytical tests conducted to sanitary quality for its intended use, microorganisms of public health determine whether agricultural water is proposed provisions in § 112.43 for significance into covered produce. safe and of adequate sanitary quality for water treatment can be applied. Water temperature can influence its intended use; However, we are not proposing processes leading to infiltration of (3) Scientific data or information you treatment of water as the only option. microorganisms into many types of rely on to support the adequacy of a Other options for farms include making produce. As discussed in the QAR, method used to satisfy the requirements changes to the system and retesting the infiltration of water containing of § 112.43(b) and (c)(1); water successfully (§ 112.42(d)) and pathogens into produce has been (4) Documentation of the results of using the same water source for other demonstrated in apples (Ref. 160), water treatment monitoring under uses for which it does qualify. For oranges (Ref. 161), tomatoes (Ref. 138. § 112.43(c)(2); example, using water that does not meet Ref. 139), and mangoes (Ref. 38) and (5) Documentation of the results of the zero E. coli standard but does meet was suggested to play a role in a 1999 water testing you perform to satisfy the the 235 CFU per 100 ml standard for Salmonella outbreak associated with requirements of § 112.44;

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(6) Scientific data or information you rate, immersion time, or water changes, the requirements of § 112.44(d). Such rely on to support any alternative to the if they significantly impact the documentation will enable us to verify, requirements established in § 112.44(c) effectiveness of the treatment. and you to ensure, that the alternative for agricultural water used during Monitoring frequency may be affected standard you use provides the same growing activities using a direct water by product flow, organic load on level of public health protection as the application method in accordance with incoming product, temperature, UV standard in proposed § 112.44(c) and the requirements of § 112.44(d); and exposure, and consumption rates or does not increase the likelihood that the (7) Annual documentation of the breakdown rate (expected and observed) covered produce will be adulterated, in results or certificates of compliance for the active antimicrobial compound, accordance with proposed § 112.12. from a public water system under among other factors. These records are We are proposing in § 112.50(b)(7) 112.45(a)(1) or (2), if applicable. necessary so that FDA can verify your that if you use water from a public water Proposed § 112.50(b)(1) would require compliance with those requirements. system, you must establish and keep that you establish and keep records of They will also allow you to ensure your annual documentation (e.g., certificate agricultural water system inspection own compliance with the requirements of compliance, water quality testing findings in order for FDA to verify for water treatment in proposed results) demonstrating that system compliance with the proposed § 112.43. supplies water meeting the microbial requirement to inspect the agricultural We are proposing in § 112.50(b)(5) requirements of § 112.45(a)(1) or (2), if water system. The records would also that you must establish and keep applicable. We tentatively conclude that allow you to more effectively manage records of the results of water testing maintaining such annual documentation your agricultural water, to identify you perform to satisfy the requirements is necessary for FDA to verify that the trends and changes in your agricultural of § 112.44. For example, records for water you use is not subject to the water system over time, and to help requirements for testing under proposed identify potential sources of water tests you perform to ensure input § 112.45 and to ensure that it meets the contamination of the water system and water used in sprout production meets microbial requirements of proposed covered produce. In addition, these the requirements in § 112.44(a) would 112.44, and for you to demonstrate that records may aid you in determining the include, at a minimum, the test date, those requirements have been met. We most appropriate frequencies for specific water source (e.g., municipal seek comment on the appropriateness of maintenance of well and surface water water or well number 3), method name the proposed record-keeping sources, distribution and holding (e.g., multiple tube fermentation, systems. membrane filter method, presence- requirements. Proposed § 112.50(b)(2) would require absence test, and commercial product F. Subpart F—Standards Directed to that you establish and keep records of name, if applicable) and the test result Biological Soil Amendments of Animal any analytical test results from any tests (e.g., not detected, generic E. coli MPN Origin and Human Waste you may have conducted to determine or CFU, as applicable). Records you if water meets the quality requirements maintain to demonstrate the microbial Proposed subpart F establishes proposed in § 112.41. We have water quality meets the requirements of standards directed to treated and tentatively concluded that these records § 112.44(c) for foliar application of untreated biological soil amendments of are necessary because otherwise FDA spinach would include, at a minimum, animal origin and human waste. These would have no way to determine the test date, specific water source (e.g., standards include requirements whether you were making appropriate ranch X, well 3 or canal collection point applicable for determining the status of decisions about whether your water is 2), method name (e.g., multiple tube a biological soil amendment of animal safe and of adequate sanitary quality for fermentation, membrane filter method, origin; procedures for handling, its intended use. When such tests are and commercial product name, if conveying, and storing biological soil conducted, results of those tests are also applicable) and the test result (e.g., E. amendments of animal origin; fundamental in making informed coli MPN or CFU, as applicable). We provisions regarding the use of human decisions concerning your use of water. tentatively conclude that documentation waste in growing covered produce; We are proposing under § 112.50(b)(3) of the results of water testing are acceptable treatment processes for and (4) that you must establish and keep necessary to demonstrate that the water biological soil amendments of animal scientific information or data you use meets the requirements of origin applied in the growing of covered documenting the effectiveness of the § 112.44 and to provide a history of the produce; microbial standards applicable treatment method that you use and microbial quality of your water system, to treatment processes; application records demonstrating that you deliver which will be useful in spotting requirements and minimum application the treatment consistently to ensure the problems before they occur, minimizing intervals; requirements specific to water is safe and of adequate sanitary the potential for water to be a source of agricultural teas; and records quality. These records may include contamination to covered produce. requirements. The proposed information provided by the These records are necessary so that FDA requirements in subpart F derive from antimicrobial product supplier, product can verify your compliance with those current recommendations in our GAPs labels with instructions for use, product requirements and so that you can ensure guidance (Ref. 10), commodity-specific material safety data sheets (MSDS), your own compliance with the guidances (Ref. 31) (Refs. LGMA), State batch test results demonstrating correct requirements for water testing and regulations (Ref. 90. Ref. 163. Ref. 164), active ingredient concentration, mixing responding to test results in proposed other Federal Regulations (40 CFR 503, proportions, and schedules or § 112.44. In proposed § 112.50(b)(6), we 7 CFR 205), and international guidelines application rates you have developed to would require you to establish and keep (Ref. 100. Ref. 51). ensure water is treated effectively. They that scientific data or information you 1. Comments Relevant to Proposed may also include results of testing you rely on to support any alternative to the Requirements perform to confirm your treatment requirements established in § 112.44(c) methods are being followed, such as for agricultural water used during We received several comments in records of active ingredient growing activities using a direct water response to the 2010 FR notice that concentration, pH, temperature, flow application method in accordance with addressed issues relevant to biological

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soil amendments of animal origin and Wildlife Service) (Ref. 115). As sources (Ref. 166), have differing human waste. discussed in section III.A.8. of this likelihood of containing human document, we tentatively conclude that pathogens or higher population levels of a. Definitions compliance with the provisions of this human pathogens. To address this One comment stated that manure and proposed rule would not preclude concern, we propose separate, but compost are two different things, and compliance with the requirements for related, provisions. First, we do not the two words should not be used organic certification in 7 CFR part 205, propose treatment or timing restrictions interchangeably as it causes confusion. and we seek comment on this tentative for biological soil amendments that do We agree. As discussed in the QAR, and conclusion. Use of organic practices not contain any animal waste product or noted in the Produce Safety Project alone is not sufficient to ensure food human waste (such as would be the case Issue Brief on Composting of Animal safety. The use of raw manure at a time with yard waste, purely vegetative Manures there are documented close to harvest, during organic or matter, or shrub trimmings, or differences in the populations and level conventional production, presents a agricultural teas made from such of human pathogens in raw manure and significant likelihood of contamination materials). Such biological soil animal feces and in properly composted of covered produce if produce is amendments would not be subject to the manure (Ref. 27). We are proposing reasonably likely to contact the soil. On requirements in proposed subpart F definitions that make the distinction this particular issue, and as discussed in because they would not fit the clear. We are proposing to use the sections II.E.4 and V.B of this document, definition of ‘‘biological soil phrase ‘‘untreated biological soil we are working with USDA and other amendments of animal origin’’ and they amendments of animal origin’’ as a stakeholders to conduct research on do not contain human waste. Further, in category that includes raw manure (see application intervals necessary to § 112.51(b)(4) we propose that a proposed § 112.3(c) and section ensure the safety of covered produce biological soil amendment of animal V.A.2.b.iii of this document regarding when raw manure is applied to a origin contains a component that is ‘‘biological soil amendment of animal growing area and covered produce is untreated waste that you know or have origin,’’ and proposed § 112.51(a) and reasonably likely to contact the soil. We reason to believe is contaminated with section V.F.2.a of this document also note that we considered several a hazard or has been associated with regarding ‘‘untreated’’ biological soil regulations, recommendations, and foodborne illness, you must regard it as amendments of animal origin). We use guidelines that address soil if it were an untreated biological soil the term ‘‘treated biological soil amendments, including those from amendment of animal origin for amendments of animal origin’’ to State, federal, and international application and treatment purposes if include treatments that meet the agencies, industry, and trade you still wish to utilize it. In addition, requirements of the standards presented associations (including the California we treat ‘‘table waste’’ as ‘‘animal in this subpart (see proposed § 112.51(a) code of regulations for composting waste’’ for the purposes of the definition and section V.F.2.a of this document). yards). In addition, we consulted with of biological soil amendments of animal To further alleviate confusion, we use experts from multiple organizations and origin. As discussed in the QAR, post- the term ‘‘compost’’ as a verb, to mean academia for scientific and technical consumer waste, or table waste (such as the act of composting, and do not use it input on the issues addressed in these plate scrapings), has a greater likelihood as a noun to describe a soil amendment provisions. The provisions proposed of being contaminated, or contaminated that was treated by a composting take into account information and input at higher populations, with human method. Instead, we use the term gathered through these consultations. pathogens due to its unknown content ‘‘humus’’ in its common agricultural (e.g., animal products, vegetable meaning (see proposed § 112.3(c) and c. Treatments, Processes, and Practices products, etc.) and its greater likelihood section V.A.2.b.iii of this document). One comment suggested that many growers are accepting food waste of containing human fluids or waste b. Consideration of Other Regulations compost, which has no manure in it but (e.g., spittle, vomitus, etc) (Ref. 167). and Guidances can often have a readily detectable level Proposed § 112.56(a)(1)(i) would Comments from growers whose of Salmonella, and stated that ‘‘green require that if you apply a biological soil operations are certified for organic waste’’ (or similar) does not necessarily amendment of animal origin that is produce requested us to ensure that our equate to zero risk. Comments stated untreated (such as raw manure), where regulations do not interfere with that if raw manure is used, there should covered produce is reasonably likely to existing organic certification systems or be a science- and risk-based standard for contact the soil after application, the organic production practices. Another determining the application-to-harvest material must be applied in a manner comment stated that the California code waiting interval and that maximizing that does not contact covered produce of regulations for composting yards (Cal. the time interval between soil during application and minimizes the Code Regs. title. 14, ch. 3.1) would be amendment application and harvest is potential for contact with covered an acceptable starting point in only logical if using fresh manure. produce after application and the developing our regulations. Similarly, one comment stated that raw minimum application interval is nine We consider that organic production manure can be applied to soil if it is (9) months. In section V.F.2.f. of this practices and food safety are not cross- plowed and then given sufficient time document we discuss the reasons for competing goals. In developing the before planting. this proposed requirement in detail. provisions proposed in this rule, we Our review of various composting Proposed § 112.56(b) would allow you consulted with technical experts and methods suggests that, regardless of the to establish and use an alternative representatives from other Federal source, if the process is properly application interval under certain Agencies, including the Environmental conducted (including proper turning of conditions (discussed further in section Protection Agency, the Department of feedstock) the expected pathogen load V.B. of this document). In situations Agriculture (including both the National and subsequent likelihood of produce where the covered produce will not Organic Program and the Natural contamination can be minimized. We contact the soil after application, Resources Conservation Service), and agree that certain sources, including proposed § 112.56(a)(1)(ii) would the Department of the Interior (Fish & plant material (Ref. 165) and animal require that the biological soil

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amendment of animal origin be applied verified through testing, and good pathogens is not fully established but in a manner that does not contact the handling practices were followed. This that further research may help refine produce at or after application, but is proposed in subpart 112.60(b)(2) and time and temperature parameters for would not require an application we request comment on this proposed chemical inactivation. interval. Also, as discussed in section requirement, including periodic We agree that further research and II.E.4. of this document, FDA is verification through testing. innovation may lead to alternatives to collaborating with partners on research heat treatments. Proposed § 112.54 d. Testing for Pathogens that may provide scientific support for addresses the use of physical processes, specific alternatives to this proposed Several comments suggested that chemical processes, or combinations of application interval. variable minimum application-to- physical and chemical processes, in One comment stated that compost harvest waiting intervals should be addition to composting, that may be made with animal manure must meet applied using science-based knowledge used as treatments for biological soil temperature, mixing, and time about pathogen levels in and transfer amendments of animal origin, provided requirements to ensure its safety, from compost, and that if a compost that they meet the applicable whereas another comment stated that tests pathogen-free, there should be no requirements of § 112.55 and the treated biologically active soil suppresses time limit between application, biological soil amendment of animal pathogens and that E. coli pathogens planting, and harvest. Another comment origin is applied in accordance with the decline more rapidly in soils with a stated that pathogen testing has applicable requirements in § 112.56. We large diversity of microorganisms rather significant limitations, and that it would consider heat treatments to be physical than in sterile soils. One comment be more important to evaluate a processes within the meaning of that recommended that we require compost treatment process to ensure that it is term in § 112.54, and we have operations to have standard operating effective in inactivating pathogens. purposefully chosen the broader term procedures, a quality assurance plan, We considered testing of individual ‘‘physical processes’’ to allow for compost testing within specified lots of biological soil amendments of possibilities other than heat treatment. timeframes of sale, and a Hazard animal origin as a means to determine Thus, these proposed requirements Analysis Critical Control Point (HACCP) if they were suitable for application to would allow for the use of alternatives program. According to this commenter, a fresh produce growing area and to heat treatment, and are intended to be several growers are requesting testing tentatively conclude that such testing is flexible to foster innovation and prior to purchase, and are refusing not a reliable means of determining the development of new means of treating compost that has not been recently safety or expected likelihood of biological soil amendments of animal tested. contaminating produce by use of origin to ensure produce safety. Based on our review of the literature biological soil amendments of animal and as discussed in our QAR, we origin. We have multiple concerns that 2. Proposed Requirements determined that improper composting led us to this conclusion. First, we were As proposed in § 112.3, ‘‘soil will not have the desired pathogen unable to determine standardized amendment’’ would be defined to mean reduction effect, and may enhance the testing methods, such as sample any chemical, biological, or physical survival of pathogenic organisms (Ref. collection methods, sample collection material (such as elemental fertilizers, 168). Therefore, we propose specific times, or location of sample collection, humus, manure, non-fecal animal time and temperature controls for which would yield repeatable and byproducts, peat moss, perlite, pre- composting procedures in proposed reliable results under different consumer vegetative waste, sewage § 112.54(c), and further recognize the circumstances. Second, we were unable sludge biosolids, table waste, need for composters to consider other to determine the frequency and sample agricultural tea and yard trimmings) factors that will impact the successful size that would reliably indicate the intentionally added to the soil to treatment of their particular composting microbiological safety of a given manure improve the chemical or physical situation (e.g., feedstock, C:N ratios, lot. Third, we recognize that there are condition of soil in relation to plant pH). We consider that the potential numerous pathogens which may be growth or to improve the capacity of the effects of soil ecological diversity on present in biological soil amendments of soil to hold water. Additionally, pathogen populations are regionally animal origin and that pathogen testing ‘‘biological soil amendment’’ would be specific, and may be highly effective would be necessary for all such defined in § 112.3 to mean any soil under some circumstances, while potential contaminants, which would be amendment containing biological potentially inert under other a significant economic burden. materials such as humus, manure, non- circumstances. We recognize the need Therefore, we tentatively conclude that fecal animal byproducts, peat moss, pre- for consistent treatment by suppliers of an approach that is the most reasonable consumer vegetative waste, sewage treated biological soil amendments of and the most protective of public health sludge biosolids, table waste, animal origin, and for assurance by would involve the use of treatments that agricultural tea, or yard trimmings, those that use such amendments that have been validated to meet certain alone or in combination. Finally, the material has been produced under specified microbial standards as proposed § 112.3 would define adequate conditions, to avoid it being a proposed in this subpart. ‘‘biological soil amendment of animal source of contamination. We have origin’’ to mean a biological soil tentatively concluded that the most e. Research Needs amendment which consists, in whole or reliable and least burdensome proposal Some comments suggested that there in part, of materials of animal origin, regarding the use of purchased treated is a need for research to identify means such as manure or non-fecal animal biological soil amendments of animal other than through heat to inactivate byproducts, or table waste, alone or in origin is to require growers to obtain pathogens, and that such alternative combination, and would specify that the certain documentation (such as a approaches may be more practical for term does not include any form of Certificate of Conformance) from the farmers. Comments opined on the use of human waste. See section V.A.2.b.iii. of treating operation that validated chemical inactivation, and noted that this document. Proposed subpart F is treatment methods were utilized, the the effectiveness of use of volatile acids focused on biological soil amendments treatment process is periodically or ammonia in the inactivation of of animal origin, which include animal

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manures and other materials of animal human enteric pathogens. Unless § 112.44(a) to prevent the introduction origin that you intentionally add to a otherwise specifically noted, chemical of pathogens into treated agricultural growing area, and on human waste. soil amendments, physical soil teas, which can be applied with fewer Standards directed to animal feces amendments, and biological soil application restrictions than untreated deposited by domestic or wild animals amendments that are not of animal agricultural teas in accordance with that are not a part of your planned origin (other than those that contain proposed § 112.56. As discussed in growing activities (e.g., by working human waste, which are covered by section V.E.2.d of this document, the animals, by animals that graze or proposed § 112.53) are not covered by conditions under which agricultural tea encroach into your growing areas) are this rule. We encourage comment on our is produced (moist and nutrient-rich) proposed to be included in subpart I, as tentative decision not to provide support the multiplication of pathogens, discussed in section V.I. of this requirements for the use of these kinds if present (Ref. 142). Even a low number document. of soil amendments in this proposed of pathogens introduced into or onto As discussed in the QAR, animal rule. covered produce through contaminated waste is likely to contain bacterial a. Requirements for Determining Status water could rapidly increase to levels pathogens (e.g., Campylobacter, that could present risk of serious Proposed § 112.51 would establish Salmonella spp., enterohemorrhagic E. adverse health consequences or death to requirements for determining the status coli) and various other pathogens such those who consume the covered of a biological soil amendment of as parasites (e.g., Cryptosporidium produce for which the tea was used animal origin for use in covered (Ref. 142). parvum, helminthes), which may infect activities. Proposed § 112.51(a) would humans. The type of pathogen that may categorize a biological soil amendment Proposed § 112.51(b) addresses the be present, and the extent to which it of animal origin as treated if it has been situations in which a biological soil may be present, is dependent on the processed to completion to adequately amendment of animal origin should be source of the manure (e.g., E. coli is reduce microorganisms of public health regarded as untreated because they more common from ruminants such as significance in accordance with the present a greater likelihood of cattle, whereas Salmonella is more requirements of § 112.54, or in the case contamination to covered produce than common from fowl such as chickens) of an agricultural tea, the biological a treated biological soil amendment of and the rearing practices of the source materials used to make the tea have animal origin. A treated biological soil animals (e.g., animals from densely been so processed and the water used to amendment of animal origin can be populated farms or farms with a high make the tea satisfies the requirements expected to have a high content of population of immature animals have an of 112.44(a). Section 112.51(b) would available nutrients and minerals which increased likelihood of harboring categorize a biological soil amendment can support rapid and prolific microbial various pathogens) (Ref. 169). Enteric of animal origin as untreated if: (1) It population growth if sufficient moisture (or gastroinstestinal) pathogens are not has not been processed to completion in is available, possibly with limited generally considered to be accordance with the requirements of competitive native microflora (Ref. 171) environmental, and are more commonly § 112.54, or in the case of an agricultural (depending on the specific treatment, expected to be derived (and in higher tea, the biological materials used to treatment parameters, and handling populations) from a human or animal make the tea have not been so processed used, (e.g., heat treated poultry manure source (e.g., through feces, mortalities, or the water used to make the tea does pellets would be expected to have blood, spittle, etc.) (Ref. 170). Material not satisfy the requirements of limited microorganism content that does not contain any animal waste 112.44(a); (2) it has become including competitive native microflora, is far less likely to harbor these food contaminated after treatment; (3) it has and composted manure would be safety hazards at microbial populations been recombined with an untreated expected to have substantial that can reasonably be expected to lead biological soil amendment of animal competitive native microflora)) (Ref. to severe adverse health consequences origin; (4) it is or contains a component 171. Ref. 172). Accordingly, pathogens or death (Ref. 94). We have tentatively that is untreated waste that you know or could grow prolifically in a treated concluded that the likelihood of have reason to believe is contaminated biological soil amendment of animal contaminating produce by use of with a hazard or has been associated origin if it were to become contaminated biological soil amendments that do not with foodborne illness; or (5) it is an through contact or partial mixing with contain animal waste or human waste agricultural tea that contains an an untreated biological soil amendment (e.g., yard trimmings, pre-consumer agricultural tea additive. of animal origin, or other potential vegetative waste) carrying human Proposed § 112.51(a) would provide a contaminant source, and if sufficient pathogens is low. Similarly, we are simple method of referring to biological moisture were available (Ref. 171). unaware of a situation in which soil amendments of animal origin as Prolific microbial growth could also chemical and physical soil treated if they have received one of the occur through premature termination of amendments, such as elemental treatment processes described in treatment, which could leave surviving fertilizers (e.g., potash, aqueous proposed § 112.54. We discuss those microorganisms and a higher moisture nitrates), soil stabilizers (e.g., sand or treatment process options in detail in content than after composting is crushed rock) or others typically made section V.F.2.d of this document. completed. In addition, if a biological of mined or synthetic materials, have Agricultural teas are mentioned soil amendment of animal origin served as sources of microbial separately for two reasons. First, contains a component that is untreated contamination and, therefore, neither treatments are typically applied to the waste that you know or have reason to chemical nor physical soil amendments biological materials used to make believe is contaminated with a hazard or are a focus of provisions of this rule. agricultural teas rather than to the teas has been associated with foodborne Therefore, in this proposed subpart F, themselves and our explicit mention of illness, we tentatively conclude that the we are proposing to focus on biological this fact is intended to aid in clarity. increased likelihood of pathogen soil amendments of animal origin and Second, we specify that the water used presence in such materials results in a human waste, which present a to make a treated agricultural tea must need to apply the most stringent reasonable likelihood of harboring meet the standard in proposed controls to their use in the growing of

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covered produce. Prolific growth of a animal origin could lead to the biological soil amendment of animal human pathogen in a nutrient-rich, amendment acting as an inoculum that origin previously treated to reduce possibly competition poor, biological spreads microorganisms on any field or pathogens can become re-contaminated soil amendment of animal origin could covered produce growing area to which by pathogens if not properly handled lead to the amendment acting as an the amendment may be applied, as well and stored (Ref. 175). For example, if inoculum that spreads microorganisms as to food-contact surfaces, areas used you fully compost manure produced by on any field or covered produce growing for covered activities, water sources, your cows with the intent of using it to area to which the amendment may be and water distribution systems. To amend a field you use to grow covered applied, leading to a potential fulfill the proposed requirement in produce, proposed § 112.52(b) would significant likelihood of produce § 112.52(a), we would expect you to take require that you handle, convey, and contamination. To avoid such specific measures to ensure that store the fully composted manure in a inoculation, we propose to require you untreated biological soil amendments of manner and location to prevent its to regard any biological soil amendment animal origin do not contaminate contamination by raw manure, or by of animal origin that is partially or covered produce directly or indirectly manure in the composting process. This incompletely treated as an untreated through contact with food contact requirement is critical because bacterial biological soil amendment of animal surfaces, areas in which covered pathogens, such as E. coli O157:H7 or origin. Finally, we tentatively conclude activities are conducted, water sources, Salmonella spp., if allowed to re- that agricultural teas that contain or distribution systems. Such measures contaminate finished compost, may agricultural tea additives should be may include, for example, separation of grow and spread to populations that regarded as untreated biological soil treated and untreated manure (or other present a significant likelihood of amendments in light of their content biological soil amendments of animal contaminating any environment in and the likelihood that they contain origin) and preventing any leachate which the soil amendment is used (Ref. human pathogens. originating from untreated biological 171). An example of cross- As discussed in section V.F.2.f. of this soil amendments of animal origin from contamination may include turning a document, we tentatively conclude that becoming a source of contamination for pile of manure that is in the process of the treatment process (including source water or water distribution composting with a front-end loader, and composting processes) can reduce the systems (Ref. 173). then proceeding to handle fully populations of pathogens significantly. As discussed in the QAR, any composted humus from a mature pile However, it has been recently reported untreated biological soil amendment of with the same equipment. To avoid that while pathogens that are present in animal origin that contaminates a food such cross-contamination, you could agricultural teas made from properly contact surface could be a source of clean the front-end loader between composted humus are reduced to further cross-contamination to covered manipulating an incomplete pile and undetectable levels within 8.5 days, produce. Moreover, a biological soil manipulating a mature pile; move such agricultural teas with added amendment of animal origin that has ‘‘downstream,’’ beginning with sanitary nutrient supplements (i.e., agricultural been treated by a composting process equipment and manipulating the most tea additives) allow low populations of may still have a residual population of mature piles first, then proceeding to remaining E. coli O157:H7, Salmonella, pathogens, since composting is not a less mature piles; or designate certain and fecal coliforms to grow and complete kill step (Ref. 174); therefore, equipment to only be used on piles of multiply (Ref. 142). For this reason, we such biological soil amendments require a certain maturity; or adopt other propose to impose the same application a multiple hurdle approach to minimize strategies that meet the same goals. restrictions on agricultural teas that the likelihood of introducing pathogens have been prepared with nutrient to a field on which they are applied. If Proposed § 112.52(c) would require additives as those that we propose for composted material contaminates a food you to handle, convey, and store any the use of untreated biological soil contact surface, the combined presence biological soil amendment of animal amendments of animal origin, such as of available nutrients plus any origin that has become contaminated raw manure (proposed § 112.56(a)(1)(i)), pathogens that may have survived the (for example, by an untreated or in- and seek comment on this proposal. See composting process present a potential process biological soil amendment of section V.F.2.f. of this document for source of contamination for any covered animal origin) as if it was untreated. In further discussion of the reasons for produce that comes in contact with the other words, a treated biological soil these restrictions. contaminated food contact surface. amendment of animal origin that has Further, a fully heat-treated biological become contaminated would need to be b. Requirements for Handling, soil amendment of animal origin, while applied in accordance with the Conveying, and Storing reasonably likely to be free of application and interval restrictions of Proposed § 112.52 would establish pathogens, may act as a source of proposed § 112.56(a)(1) for untreated requirements for handling, conveying nutrients for pathogens that might biological soil amendments of animal and storing soil amendments of animal contaminate the food contact surface, origin, or it would need to be treated in origin. Specifically, we propose in thereby allowing them to multiply and compliance with one of the options in § 112.52(a) that you handle, convey, and pose a likelihood of contaminating any proposed § 112.54 and then applied in store any biological soil amendment of produce coming in contact with the accordance with the applicable animal origin in a manner and location food contact surface. requirements in § 112.56 for the such that it does not become a potential As proposed, § 112.52(b) requires that treatment used. For example, if a treated source of contamination to covered you handle, convey and store any or in-process biological soil amendment produce, food-contact surfaces, areas treated biological soil amendment of of animal origin becomes used for a covered activity, water animal origin in a manner and location unintentionally contaminated (e.g., from sources, and water distribution systems. that minimizes the likelihood of it runoff from an untreated biological soil As discussed immediately above, becoming contaminated by an untreated amendment of animal origin), you prolific growth of a human pathogen in or in-process biological soil amendment would either need to treat that material a potentially competition-poor, nutrient- of animal origin. This proposed in accordance with an option in rich, biological soil amendment of requirement is necessary because a proposed § 112.54 and then apply it in

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accordance with the applicable proposing to implement further soil amendment of animal origin will requirements in § 112.56 for the restrictions. Our proposed definition of result in it contacting covered produce treatment used, or you would have to agricultural teas, discussed in section increases, the extent of measures taken follow the application requirements for V.A.2.b.iii. of this document, would to reduce the likelihood of known or untreated biological soil amendments of provide that agricultural teas are not reasonably foreseeable microbial animal origin in proposed § 112.56(a)(1) made from any form of human waste hazards being present in the applied soil for the contaminated material. because doing so would not be amendment must also increase. That is, permissible under 40 CFR part 503 c. Prohibition Regarding Use of Human for an application practice that is more subpart B. Waste likely to result in the amendment d. Acceptable Treatment Processes contacting covered produce (e.g., Proposed § 112.53 would prohibit the broadcast application of a soil use of human waste for growing covered Although there is great variability in amendment vs. subsurface soil produce, except sewage sludge biosolids available data on pathogen survival in amendment injection for the same crop, used in accordance with the animal manure depending on the type or in-row application of a soil requirements of 40 CFR Part 503, and source of manure in question, the amendment for a row crop vs. in-row subpart D, or equivalent regulatory location and environment under which application for a tree crop), it is more requirements. Human waste has a high the manure is stored, and numerous important to have stricter controls for probability of containing multiple other factors (Ref. 176. Ref. 177. Ref. known or reasonably foreseeable diverse human pathogens, including 178) there are data to suggest it is microbial hazards in the applied soil bacteria, parasites and viruses, at reasonable to expect that, given the amendment than for another potentially very large populations, thus proper conditions, pathogens in certain amendment whose application practice presenting a significant likelihood of animal manures may survive for months is less likely to result in the amendment harboring and spreading these various (Ref. 179), years (Ref. 180), or even coming into contact with covered microbiological hazards (Ref. 92). We indefinitely (Ref. 174). Because the use produce. Therefore, proposed § 112.54 recognize that an application of of soil amendments that contain consists of multiple acceptable options untreated human waste could occur materials of animal origin poses a for the treatment of soil amendments outside of your control (for example, as significant likelihood of contaminating and corresponding standards against a run-off event from adjacent land not the growing environment and covered which they are to be validated (as under your control), or may have produce with human pathogens, we further described in § 112.55). These occurred as a previous use of land have tentatively concluded that such proposed treatment options were before you took possession. If you know materials used as a soil amendment designed to be flexible to allow you to or have reason to believe such an event require some level of treatment, or other determine what your operation’s needs has occurred, we would expect you to risk-reducing steps (such as application are, and select the option that best fits take measures reasonably necessary to restrictions), for use in the growing of those needs. In developing these minimize the risk of serious adverse covered produce. Proposed § 112.54(a)– proposed requirements, we have taken health consequences or death based on (c) would establish acceptable treatment into account the wide variation your specific circumstances. Such processes for a biological soil presented by different feedstocks used measures may include crop diversion, amendment of animal origin when in preparing biological soil amendments reconditioning or destruction, and/or applied in the growing of covered land remediation, or other comparable produce, along with associated of animal origin, the diversity of methods. microbial standards against which they commodities, and various growing Under 40 CFR part 503 subpart D must be validated in proposed § 112.55. regions. In addition, we considered the (§ 503.30, 31, 32 and 33), the U.S. EPA A validated process, when properly likelihood of contamination posed by requires that the application of sewage implemented and monitored, would be biological soil amendments of animal sludge biosolids to fields in which food expected to meet the listed microbial origin subjected to each of these or feed crops are grown adhere to standards and thereby reduce the multiple treatment options when certain pathogen reduction likelihood of hazards associated with determining the appropriate application requirements, and use certain vector biological soil amendments of animal requirements, as proposed in § 112.56. attraction reduction options. Depending origin from contaminating covered We have tentatively concluded that the on which options are implemented, produce. The microbial standards in use of the physical, chemical, and there are different ranges of wait periods proposed § 112.55 are not meant as lot- composting treatments listed in between application of the soil by-lot microbial testing requirements. proposed § 112.54(a)–(c), when applied amendment, and the harvest of the crop Instead, the person applying the in accordance with proposed § 112.56, grown. For example, if an untreated treatment process would need to are capable of adequately reducing human waste (i.e., equivalent to monitor the physical parameters of the pathogen levels in biological soil domestic septage: ‘‘Liquid or solid process (e.g., temperature of a compost amendments of animal origin. We material removed from a septic tank, pile) to ensure that they meet the request comment on the appropriateness cesspool, portable toilet’’) (40 CFR conditions under which the process was of each of the options considered, and 503.9(f)), is applied to a field used to validated. In addition, proposed discussion of any other options not produce a food crop, then ‘‘Food crops § 112.54 would provide that the listed in proposed § 112.54. with harvested parts that touch the resulting biological soil amendments Physical treatments usually involve sewage sludge/soil mixture and are must be applied in accordance with the some form of high-heat treatment totally above the land surface shall not applicable application requirements in (cooking) of the biological soil be harvested for 14 months after § 112.56. We seek comments on this amendment of animal origin to kill application of sewage sludge’’ (40 CFR approach. undesirable microorganisms. By 503.32(c)(1), cross-referencing § (b)(5) of The underlying framework for the contrast, chemical treatments usually the same section). We agree these provisions of §§ 112.54(a)–(c), 112.55, involve greatly altering the pH of a standards are appropriate for protecting and 112.56 is that as the likelihood that biological soil amendment of animal public health and, therefore, we are not a method of application of a biological origin, to the point that undesirable

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microorganisms do not survive. In a composting treatment that meets the animal origin. Two specific study treating chicken manure with composting standard proposed in scientifically valid controlled ammonia to reach high (alkaline) pH § 112.54(c) followed by a subsequent composting processes that could be levels, a 3 to 4 log decrease of generic heating process that meets the microbial used to meet the requirements of E. coli was observed over 6 days at 20°C, standard of proposed § 112.55(a). proposed § 112.54(c) are provided: (1) and drying manure to 10% moisture Together, the treatment reduces over 7 Static composting that maintains content and exposing it to ammonia gas log cfu/g of Listeria, Salmonella, and E. aerobic (i.e., oxygenated) conditions at a (1% of manure wet weight) reduced coli O157:H7 to undetectable levels (Ref. minimum of 131 °F (55 °C) for 3 days pathogen load by 8 log (99.999999% 183). It also eliminates much of the and is followed by adequate curing, reduction) (Ref. 181). To perform either native microflora (Ref. 183). We have which includes proper insulation; and physical or chemical treatments, the tentatively concluded that a treatment (2) turned composting to maintain feedstock is generally placed in a large meeting this standard would aerobic conditions at a minimum of treatment container, and large amounts significantly reduce or eliminate known 131 °F (55 °C) for 15 days, with a of energy are required in order to or reasonably foreseeable microbial minimum of five turnings, and is initiate the treatment. These factors hazards in biological soil amendments followed by adequate curing, which alone make these forms of treatment of animal origin, and would constitute includes proper insulation. These two impracticable for many farms. While the lowest expected likelihood of any of composting processes are currently such treatments can be expected to have the proposed treatment options. We considered by the U.S. Environmental a strong lethal impact on have also tentatively concluded that a Protection Agency as Processes to microorganisms present in the biological soil amendment of animal Further Reduce Pathogens (Appendix B feedstock, they do not always result in origin that has been treated to this to 40 CFR part 503, part B.1). Both are complete elimination of pathogens. For standard would be appropriate for use recommended for use by the U.S. example, chicken manure may be heat- when the likelihood for contamination Department of Agriculture’s treated to create a dried, pelleted of covered produce is the highest, such Agricultural Research Service (Ref. 184), material that is functionally sterile due as the substrate (growth media) used for Natural Resources Conservation Service to the high heat used during production; growing mushrooms and some sprouts. (Ref. 97), and National Organic Program however, it has been observed that if the Therefore, as provided in proposed (7 CFR part 205), and both are heat treatment is not uniform, the end § 112.56(a)(2) and discussed further in commonly accepted practices within the product may still harbor human section V.F.2 f of this document, any industry (Ref. 185). While there is pathogens and pose a likelihood of the biological soil amendment of animal robust discussion in the literature on material being re-colonized by the origin treated to this standard would times, temperatures, and other microbial pathogen, leading to the have the fewest limitations on its conditions (pH, moisture, oxygen levels, possible contamination of any covered application. etc.) needed for significant reductions produce to which it is applied (Ref. Proposed § 112.54(b) would establish (albeit not elimination) of human 115). that a scientifically valid controlled pathogens in cattle, sheep and chicken Biological soil amendments of animal physical process, chemical process, or manures, it is clear that composting origin may also be prepared by combination of scientifically valid cannot be considered as a pathogen- combining multiple treatments, either controlled physical and chemical elimination step because of the many alone or in combination. For example, a processes, that has been demonstrated variables that can affect the efficacy of single feedstock may be heat-treated to satisfy the microbial standard in the composting process (e.g., feedstock (physical) while also drenched in strong § 112.55(b) for Salmonella and fecal mixtures, climatic conditions, and ammonia (chemical) to acidify the coliforms is a treatment option for various other physio-chemical material (Ref. 182). Alternatively, biological soil amendments of animal parameters) (Ref. 174). These limits are feedstock may first be composted and origin. We have tentatively concluded currently used as composting endpoints then treated by heat to further reduce that a treatment meeting this standard by other federal agencies (40 CFR 503) pathogens, effectively pasteurizing the would significantly reduce known or States (Ref. 90. Ref. 164. Ref. 163), and material, as is common practice in the reasonably foreseeable microbial industry (Ref. 31). production of mushroom growth media hazards in biological soil amendments (Ref. 183). These systems have been of animal origin leading to minimal Composting is generally the least shown to be highly effective when likelihood of contamination. A expensive method with the lowest proper controls are in place and biological soil amendment of animal capital investment requirement, and if monitored, but they also require origin that has been treated to this properly managed, can be expected to significant inputs and capital standard would be appropriate for use significantly reduce pathogen investments. when there is a high likelihood that the populations in feedstock materials (Ref. Proposed § 112.54(a) would establish soil amendment will come into contact 186). As noted in the Produce Safety that a scientifically valid controlled with covered produce. Moreover, as Project Issue Brief on Composting of physical process (e.g., thermal), provided in proposed § 112.56 and Animal Manures, composting has been chemical process (e.g., high alkaline discussed further in section V.F.2.f of shown to reduce the overall pH), or combination of scientifically this document, any biological soil concentration of nitrogen in the soil valid controlled physical and chemical amendment of animal origin treated to amendment, which poses a concern for processes that have been demonstrated this standard would have minimal some farmers, but it also has been to satisfy the microbial standard in limitations on its application. demonstrated that the remaining § 112.55(a) for Listeria monocytogenes, Proposed § 112.54(c) would establish nitrogen is both in a more bio-available Salmonella spp., and E. coli O157:H7 is that a scientifically valid controlled state (i.e., more easily utilized by plants) a treatment option for biological soil composting process that has been and will persist in the environment for amendments of animal origin. This demonstrated to satisfy the microbial a longer time (therefore providing standard is currently used by the standard in § 112.55(b) for Salmonella nutrients to plants for a longer time) mushroom industry, which utilizes a and fecal coliforms is a treatment option (Ref. 27). Composting leaves much of two-phase process consisting of a for biological soil amendments of the native microflora intact (Ref. 187).

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Proper composting is not difficult for process to further reduce the levels of reasonably foreseeable hazard to a most operations, but it does require a pathogens, complete the chemical covered produce commodity. These labor commitment to ensure conditions reactions of composting, and mitigate standards would also be useful if you are met and maintained to achieve the the impact that incomplete turning wanted to use a biological soil desired effect. Some of the most critical (creating temperature stratification amendment of animal origin with the elements of composting include proper within an active pile) would have on least amount of application restrictions stacking of a pile, proper aeration and composting efficacy (Ref. 27). Proper available under proposed § 112.56. As turning, and ensuring the pile attains insulation serves as a layer of protection previously noted, these microbial the proper temperature and is allowed from external influences (e.g., standards are currently used by the to cool (cure) for an adequate time (Ref. temperature changes, wild animal mushroom industry for growth media 27). There are currently no federally encroachment). and reduce over 7 log CFU/g of Listeria, mandated composting standards for The treatment processes proposed in Salmonella, and E. coli O157:H7 to food safety. The USDA/NOP offers § 112.54(c), paragraphs (1) and (2), may undetectable levels (Ref. 183). standards that are meant to maximize not be the only means of achieving Proposed § 112.55(b) would provide soil fertility in 7 CFR 205.203 (these are adequate composting to meet the two microbial standards, both of which required to achieve ‘‘USDA Certified microbial standards in proposed must be satisfied for the treatment Organic’’ status, but otherwise are § 112.55(b). Therefore, we have processes in proposed § 112.54(b) and recommendations only), and EPA tentatively concluded that it would be (c). This section would require less than standards in 40 CFR part 503 are appropriate to allow for the use of static 3 MPN Salmonella spp. per 4 grams of or turned composting protocols other specific to sewage sludge, not animal total solids (dry weight basis), and less than those specified in § 112.54(c)(1) manures. While these standards were than 1,000 MPN fecal coliforms per and (2), if they meet the microbial not developed for food safety, several gram of total solids (dry weight basis). standards for validation for composting studies suggest that they would be These limits are currently used as in proposed § 112.55(b). Proposed appropriate for use as food safety composting validation endpoints by § 112.54(c)(3) allows for the use of other measures (Ref. 27). Proper handling and EPA (40 CFR 503), some States (Ref. 90. scientifically valid, controlled storage during and after composting to Ref. 164. Ref. 163), and industry (Ref. composting processes, provided you avoid cross-contamination of cured 31). Ohio and California (Ref. 163. Ref. satisfy the requirements of § 112.12, product and in-process or raw product 164), industry (Ref. 31) and other including that the alternative has been is critical, as discussed in section nations such as Canada and the United V.F.2.b of this document above demonstrated to satisfy the microbial standard in § 112.55(b). No such Kingdom (Ref. 27) use both of these regarding proposed § 112.52 of this rule. criteria, while EPA and Florida (Ref. 92. Other important factors in proper alternatives are provided for the treatment requirements of § 112.54(a) Ref. 90) allow for either criteria to be composting (such as the carbon to used. As noted in the Produce Safety nitrogen ratio of the feedstock (C:N), the and 112.54(b), because those parts do not explicitly define the processes to be Project Issue Brief on Composting of moisture content of the pile, the Animal Manures, the EPA requirement reaction to high cellulose-content conducted to meet the microbial standards presented; therefore, any of validation with either Salmonella material (i.e., plant material such as spp. or fecal coliforms is based on the straw or vegetative waste), and the scientifically valid controlled physical, chemical, or combination of physical observation that reduction in fecal specifics of the beneficial microbial and chemical processes that has been coliforms is well correlated to reduction content will vary depending on the demonstrated to satisfy the relevant in Salmonella spp. when biosolids are feedstock (Ref. 187). The person who microbial standard in either § 112.55(a), composted (Ref. 27). However, we manages the composting process would or § 112.55(b) will meet the tentatively conclude that satisfying both also need to consider such factors as the requirements of those subparts. of these criteria is necessary to moisture content, pH, carbon to nitrogen significantly minimize known or ratio (C:N), and feedstock to achieve the e. Microbial Standards Applicable to reasonably foreseeable hazards when microbial standards set forth in Treatment Processes combined with the applicable proposed § 112.55. Many resources are Proposed § 112.55 establishes application requirements in proposed available that discuss these details, such microbial standards applicable to the § 112.56. Monitoring the relative levels as the USDA NRCS handbook (Ref. 97). treatment processes in § 112.54. of indicator microbes such as fecal When composting processes are carried Proposed § 112.55(a) would provide coliforms, which are predominantly E. out in an incorrect manner, the organic microbial standards for the treatment coli in manures and freshly mixed matter in the finished product remains process in proposed § 112.54(a). It compost, is advantageous in that they poorly stabilized and recontamination is would require: (1) L. monocytogenes to are abundant in manure. In the absence more likely to occur, which can be not detectable using a method that of a reliably present pathogen, fecal potentially result in the compost can detect one colony forming unit coliforms are useful to validate the becoming a source of pathogens that (CFU) per five gram analytical portion; efficiency of the thermophilic could contaminate the field to which it (2) Salmonella spp. to be less than 3 composting process (Ref. 27). is applied and any crops that are grown most probable number (MPN) per four Additionally, E. coli, the primary fecal in the amended soil (Ref. 165). grams of total solids (dry weight basis); coliform in manure, has been As noted in the Produce Safety Project and (3) E. coli O157:H7 to be less than documented to be a good indicator of Issue Brief on Composting of Animal 0.3 MPN per 1 gram analytical portion. the inactivation of E. coli O157:H7 (Ref. Manures, adequate curing, including As discussed immediately above 168). Validating solely with Salmonella proper insulation (usually consisting of regarding proposed § 112.54(a), these spp. is not sufficiently protective or around one foot thick of insulating standards are the most stringent and useful for validating the efficiency of a material, e.g., hay, straw, finished meant for applications in which a thermophilic composting process, since compost) is included as part of this biological soil amendment of animal Salmonella spp. cannot be assumed to proposed requirement, because curing is origin would otherwise pose the greatest be present in all composting feedstock an important step in the composting likelihood of transferring a known or materials. On the other hand,

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Salmonella spp. is the most common during harvest and growing (proposed specific microbial populations of raw microbiological hazard associated with § 112.56(a)(2)), such as in the growing of manure are generally unknown, but can fresh produce (Ref. 3). As such, mushrooms and some sprouts. be expected to be very high, and are validating with fecal coliforms and Conversely, those treatments that are likely to include zoonotic Salmonella spp. not only assures the expected to have some likelihood of microorganisms that pose a food safety efficacy of the thermophilic composting harboring significant numbers of human hazard (such as Salmonella spp. up to process but also assures significant pathogens, i.e., those treated in 10∧7 (Ref. 176) and E. coli O157:H7 up reduction of the pathogen Salmonella accordance with the requirements of to 10∧6 (Ref. 189)). Based on our QAR, spp. when commonly used compost § 112.54(b) or (c), have proposed we have determined that raw animal feedstocks are used that are likely limitations on the method of application waste (manure, litter, mortalities, etc.) is sources of Salmonella spp. (e.g., cattle that minimize the potential for the likely to contain human pathogens and and poultry manure) (Ref. 188). We seek treated biological soil amendment of has the highest likelihood of comment on these proposed microbial animal origin to contact covered contaminating covered produce. standards and potential alternatives. produce during and after application Therefore, we tentatively conclude that We do not intend this proposed (proposed § 112.56(a)(3), (a)(4)(ii)) and such material should only be used provision to require that farms test their also allow for pathogen die-off when it where, and in a manner, that such treated biological soil amendments for is reasonably likely that covered likelihood is minimized. As discussed compliance with the microbial produce will contact soil after standards. Rather, we intend this above, the likelihood of produce application of the soil amendment contamination by an agricultural tea provision to provide the standard (proposed § 112.56(a)(4)(i)). against which treatment processes must that contains agricultural tea additives Requirements would include the is also high (Ref. 142). Given the desire be validated. Farms would be able to application of untreated biological soil use treatment processes that are to both allow for the continued use of amendments of animal origin in raw manure, agricultural teas containing validated to meet the relevant microbial situations where it is reasonably likely agricultural tea additives, and other standard in this section without needing that covered produce will contact the untreated biological soil amendments of to test the end products of their soil after application of the soil animal origin; and to minimize the risk treatments to confirm that the microbial amendment (§ 112.56(a)(1)(i)), where the of known and reasonably foreseeable standard was achieved. amendment would be permitted to be hazards, we have tentatively concluded applied in a manner that minimizes the f. Application Requirements and that we should require that untreated Minimum Application Intervals potential for contact with covered produce after application, but with an biological soil amendment of animal Proposed § 112.56 establishes the origin (including raw manure) applied application requirements and minimum additional food safety measure that it can be applied only in a manner that in the growing of covered produce application intervals applicable to should either first be treated to reduce biological soil amendments of animal does not contact covered produce during application and using a microbial food safety hazards; or if the origin. Proposed § 112.56(a) would covered produce is reasonably likely to establish a requirement that, except as minimum application interval of 9 months. By contrast, in situations where contact the soil after application of the provided in subparagraph (b), any soil amendment, the untreated soil biological soil amendment of animal covered produce will not contact the soil, (§ 112.56(a)(1)(ii)), the amendment amendment should be applied in a origin that you use must be applied with manner that keeps it from coming into the application method requirements would be permitted to be applied without an application interval. We contact with covered produce during and minimum application intervals application, minimizes the potential for specified in the table presenting explain each of these proposals in detail contact after application, and allows for proposed § 112.56(a)(1)–(4). The below. the die-off of pathogens; and if the different application method Proposed § 112.56(a)(1)(i) requires covered produce will not contact the requirements and intervals for biological that if you apply a biological soil soil amendments of animal origin are amendment of animal origin that is soil after application of the soil presented so that you may determine untreated, then the material must be amendment, the untreated soil the amendment, application, and applied in a manner that does not amendment should be applied in a interval that is most appropriate for contact covered produce during manner that keeps it from coming into your situation, based on the expected application and minimizes the potential contact with covered produce during likelihood of contaminating produce by for contact with covered produce after and after application. In the case of use of the biological soil amendment of application and the minimum agricultural teas containing agricultural animal origin you plan to use. application interval is nine (9) months. tea additives, we tentatively conclude In developing the application This provision would apply to any that because additional treatment is not methods requirements of proposed situation in which the covered produce an option they should be applied in the § 112.56(a)(1)–(4), we first considered is reasonably likely to contact the soil same manner as untreated biological specifications of each type of biological after application of the soil amendment. soil amendments of animal origin. soil amendment of animal origin, and Proposed § 112.56(a)(1)(ii) requires that Proposed § 112.56(a)(1)(i) would then considered the likelihood that the if you apply a biological soil therefore establish such restrictions on soil amendment will come into contact amendment of animal origin that is the manner of application for these with covered produce. For example, untreated, and the material is applied in materials when they are reasonably those biological soil amendments of a manner that does not contact covered likely to come in contact with covered animal origin treated with a process or produce during or after application, produce after application, as well as a processes capable of consistently and there is no minimum application minimum application interval (waiting reliably reducing or eliminating interval. This provision would apply to period) of nine (9) months from the pathogens as per § 112.54(a) do not have any situation in which the covered application of untreated biological soil any application restrictions, and may produce will not contact the soil after amendments of animal origin to the come into contact with covered produce application of the soil amendment. The harvest of covered produce. On the

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other hand, under proposed harvest of covered produce would be and chemical processes, in accordance § 112.56(a)(1)(ii), untreated biological protective for the preponderance of with the requirements of § 112.54(a) to soil amendments of animal origin would environments in situations where meet the microbial standard in be permitted for use with no minimum covered produce is reasonably likely to § 112.55(a), would have no application waiting period when the soil contact the soil after application of method restrictions and no minimum amendment is applied in a manner that untreated biological soil amendments of application interval. At this level of does not contact covered produce animal origin. This is not inconsistent microbial reduction, a treated biological during or after application. We with the 12-month restriction used by soil amendment of animal origin can be investigated the potential for survival of some segments of the produce industry expected to present negligible many enteric pathogens of public health (Ref. 31). Where the soil amendment likelihood of contamination. Therefore, concern (Ref. 190. Ref. 92) and does not contact covered produce either we have tentatively concluded that no determined that across various during or after application, we do not further action is necessary for the safe pathogens and their potential believe that a minimum application use of such a product in conjunction environments, pathogen survival and interval is reasonably necessary to with covered produce. die-off time in soils amended with raw prevent the introduction of known or For example, unlike other biological manures are extremely varied. One reasonably foreseeable hazards into soil amendments of animal origin, the consistency across many trials was an covered produce. Therefore, proposed nature of a growth medium that is a observed rapid early die off of many § 112.56(a)(1)(ii) provides for the option biological soil amendment of animal pathogens, followed by a prolonged to use untreated biological soil origin and is used for growing survival of the remaining low amendments of animal origin with no mushrooms, some sprouts and similarly populations (Ref. 191. Ref. 104. Ref. minimum waiting period, provided the grown produce, makes contact between 192). It is unclear in the existing soil amendment is applied in a manner the covered produce and the growth literature at what point the population that does not contact covered produce medium inevitable. This precludes the is low enough to minimize the potential during or after application. We seek ability to utilize application restrictions for contamination of covered produce; it comment on the proposed waiting as a meaningful measure to minimize is reasonable to suggest that once period. the likelihood of pathogen pathogen populations fall below One study, which specifically contamination of covered produce detection limits, their risks are addressed considerations of microbial through a multiple-hurdle approach, minimized. survival in soil and resulting transfer on that would allow for the use of less to produce grown in the soil, suggested robust treatment processes in Some of the longest survival times that, under ideal conditions for survival, combination with application manner involved organisms initially present at organisms could survive for greater than restrictions. Therefore, we tentatively very high initial populations (e.g., E. 226 days (Ref. 191). The study was conclude that, such growth media must coli O157:H7 in sheep manure (Ref. 177) performed in the Southeastern U.S. be treated by a scientifically valid surviving for 21 months) or involved (Georgia) and, therefore, is unlikely to controlled physical or chemical process, certain pathogens such as encysting reflect climatic conditions prevalent in or combination of scientifically valid parasites (Cryptosporidium parvum other areas of the country, including the controlled physical and chemical cysts surviving for over a year (Ref. 193) potential for the ground to freeze during processes, in accordance with the or the eggs of parasitic flatworms winter. While microbes present on requirements of § 112.54(a) to meet the (Ascaris ova surviving for over 15 years frozen ground can be expected to be microbial standard in § 112.55(a). (Ref. 174)). Some enteric pathogens are reduced in population more rapidly As proposed, § 112.56(a)(3) would reported to be more resilient to (Ref. 195), those surviving are likely to require that a biological soil amendment deleterious effects of the environment persist for a longer time period in a state of animal origin treated by a than others (most notably, Salmonella of dormancy (Ref. 196). The dormancy scientifically valid controlled physical seems better attuned for survival outside of microorganisms also means that they or chemical process, or a combination of of a host than does E. coli O157:H7 (Ref. will pose a likelihood of contamination scientifically valid controlled physical 194)) and those microorganisms that for greater periods of time, creating a and chemical processes, in accordance produce spores are especially hardy. wider window of opportunity for with the requirements of § 112.54(b) to Basing all manure application standards covered produce to become meet the microbial standard in on these extreme cases would be contaminated. We request comment on § 112.55(b) be used in a manner that unnecessary. The majority of survival whether and how, as an additional minimizes the potential for contact with studies showed that most enteric requirement for the application of covered produce during and after pathogens of public health importance, untreated biological soil amendments of application, with no minimum under the most common conditions, animal origin, the time period when the application interval. We have would not survive in the soil past 1 year soil is frozen should count toward the tentatively concluded that treating a (Ref. 190). This includes organisms less proposed application interval. Further, biological soil amendment of animal commonly associated with fresh it has been noted that rapid freeze-thaw origin to meet the standards of produce, such Cryptosporidium, cycles of weather may cause more rapid § 112.54(b) would significantly decrease Giardia, and Ascaris (parasitic flat die-off rates of pathogens present in the population of any microorganisms of worms). Organisms most commonly soils (Ref. 197). We request comment on public health significance that may have associated with fresh produce outbreaks the impact that freeze-thaw cycles may previously been present. Further, the (such as E. coli, Salmonella and Listeria) have on use of biological soil proposed application restriction of are unlikely to survive at detectable amendments of animal origin. minimizing direct contact of the population levels in soil past 270 days Proposed § 112.56(a)(2) would amendment with the edible portion of (Ref. 181. Ref. 182. Ref. 183). Therefore, establish that the use of a biological soil covered produce would further reduce we tentatively conclude that utilizing a amendment of animal origin treated by the likelihood of any remaining 9-month waiting period between the a scientifically valid controlled physical microorganisms in a treated soil application of untreated biological soil or chemical process, or combination of amendment contaminating covered amendment of animal origin and the scientifically valid controlled physical produce, as well as reduce the

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likelihood that the soil amendment proposed § 112.56(a)(3), there is an minimum application interval is would provide a nutrient source for any additional 45 day application interval reasonably necessary to prevent the microorganisms of public health for § 112.56(a)(4)(i) that would not be introduction of known or reasonably significance already present on covered required in § 112.56(a)(3). We have foreseeable hazards into covered produce. We have tentatively concluded tentatively concluded that process produce. Therefore, proposed that the treatment of the biological soil controls during chemical or physical § 112.56(a)(4)(ii) provides for the option amendment of animal origin, combined treatments can be expected to be less to use a biological soil amendment of with minimizing its contact with prone to failure than process controls animal origin treated by composting covered produce would adequately for composting. For example, heat with no minimum waiting period, reduce the likelihood of contamination treatments are often conducted in provided the soil amendment is applied and subsequent severe adverse health enclosed heat-treatment chambers (i.e., in a manner that does not contact consequences or death. We have also ovens), often with various means of covered produce during or after tentatively concluded that, with the agitation (such as stirring rods, etc.), application. We seek comment on the likelihood already minimized, it is that can be accurately monitored and appropriateness of the proposed unnecessary to implement a further controlled to reach the required application period intervals. burden by proposing a minimum treatment conditions throughout the We have not proposed any provisions application interval for soil material being treated. Conversely, specific to the status of spent mushroom amendments treated by physical or composting usually occurs outdoors, is mulch (growth media already used in chemical processes, or combinations of exposed to fluctuating environmental the production of mushrooms for such processes, to the standards of pressures and wildlife activity, is not subsequent use as a biological soil § 112.54(b). For example, chicken homogeneous in nature and prone to amendment of animal origin in the manure pellets that have been treated by having ‘‘cold-spots’’ that are not growing of other covered produce) and a controlled high-temperature process completely treated (even with proper specifically request comment on how to according to a protocol that has been turning) (Ref. 174). In general, in classify its status. The practice of storing validated to meet the standards in composting, there is a higher likelihood spent mushroom mulch for subsequent proposed § 112.54(b) could be used as of having a systems failure, which is use in the growing of covered produce an in-furrow side-dress for leafy greens also more likely to go undetected, is not known to be a likely source of immediately before harvest. However, in should it occur. Composting may result introduced contamination because the this same example, the application in a treated biological soil amendment growth media would have been could not be conducted by overhead of animal origin that may continue to previously treated to eliminate broadcast spreading, since this method harbor human pathogens of food safety pathogens (Ref. 62). Therefore, we would not minimize contact of the concern (Ref. 174), although any such tentatively conclude that spent biological soil amendment with the hazards that may be present can be mushroom mulch previously treated (in covered produce. Proposed § 112.56(a)(4)(i) would expected to be present at low accordance with proposed § 112.54(a), establish requirements for use of a populations and unlikely to survive for to meet the microbial standards of biological soil amendment of animal extended periods under normal § 112.55(a)) before use in the growing of origin treated by a composting process environmental conditions after mushrooms would still be considered as in accordance with the requirements of application. Examples of a system ‘‘treated’’ to meet the standards of § 112.54(c) to meet the microbial failure that may occur during § 112.54(c) after use for growing standard in § 112.55(b) in a manner that composting, but would not be expected mushrooms, and for any possible minimizes the potential for contact with during a thermal or physical treatment, subsequent use in the growing of fresh covered produce during and after could include animal intrusion, produce without any intervening application and with a minimum incomplete turning, or reduced treatment, unless you know or have application interval of 45 days. This efficiency of composting due to reason to believe it has been otherwise provision would apply to situations in environmental or climatic conditions contaminated with a hazard or has been which the covered produce is (e.g., heavy rainfall or excessive cloud associated with foodborne illness. We reasonably likely to contact the soil after cover reducing the temperature of the tentatively conclude that spent application of the soil amendment. pile or portions of the pile). Therefore, mushroom mulch should be considered, Proposed § 112.56(a)(4)(ii) requires we propose to impose an additional for the purpose of the application that if you apply a biological soil mitigation measure in situations where requirements in proposed § 112.56, as amendment of animal origin treated by covered produce is reasonably likely to though it has been treated by a composting process in accordance contact the soil after application of composting, instead of considering it as with the requirements of § 112.54(c) to biological soil amendments of animal though it has been treated in accordance meet the microbial standard in origin treated by composting by with the most robust chemical/physical § 112.55(b), and the material is applied requiring a minimum application treatment process (§ 112.54(a)), though in a manner that does not contact interval of 45 days. This time period has it would have received such a treatment covered produce during or after been shown to be effective when the in accordance with proposed § 112.54(a) application, there is no minimum population of the pathogen is minimal before its use to grow mushrooms. This application interval. This provision (Ref. 92. Ref. 91) (Ref. 198), as can be would have the effect of subjecting would apply to any situation in which expected of a fully composted biological spent mushroom mulch used the covered produce will not contact the soil amendment of animal origin. This subsequently to grow other covered soil after application of the soil multiple hurdle approach and time produce to the requirement to minimize amendment. Although the microbial interval has also been utilized in a the potential for contact with covered standards and application restrictions current industry standard (Ref. 31). produce during and after application, for biological soil amendments of Where a biological soil amendment of and a minimum application interval of animal origin treated to meet the animal origin does not contact covered 45 days. We consider the weathering requirements of proposed § 112.56(a)(4) produce either during or after process (the common practice of spent are the same as those described under application, we do not believe that a mushroom mulch being placed in a field

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in windrow for further composting over requirements that apply to raw manure produce during and after application, the course of several weeks to years) to in § 112.56(a)(1) and note that, if it is and application at least 45 days prior to be similar to composting in terms of reasonably likely that your covered harvest. likelihood of introduction of produce will come in contact with the Proposed § 112.56(b) would establish contaminants. We request comment on soil (for example, where almonds are requirements for the use of alternatives this tentative conclusion. harvested by intentionally dropping to to the minimum application intervals Under this proposal, you would, in the ground) after application of the raw established in paragraphs (a)(1)(a) and most cases, maintain the flexibility to manure, the use of raw manure is (4)(a) of proposed § 112.56, provided choose among a variety of treated and restricted to application in a manner you satisfy the requirements of § 112.12. untreated soil amendments of animal that does not contact covered produce We have tentatively concluded that, origin based on the commodity being during application and minimizes the under certain circumstances, an grown, growing conditions, and other potential for contact with covered alternative standard may be appropriate factors relevant to your operation, but produce after application, and may be if it is shown to provide the same level you would have to consider both the applied no less than 9 months before of public health protection as the method of application (e.g., whether it harvest. On the other hand, if you can standard in proposed § 112.56(a)(1)(i) would result in contact between the apply the raw manure in a manner that and (4)(a) and not to increase the amendment and the produce) and, for ensures it does not contact covered likelihood that the covered produce will be adulterated. For example, certain amendments, the interval before produce during or after application, you alternatives to the proposed minimum harvest. We would expect you to may use it without a minimum application intervals could take into determine which application method is application interval. Any minimum account specific characteristics of the most appropriate for your situation by application interval that you use can be locality, crop and the agro-ecological selecting the application method and concurrent with any application environment. Such alternatives could interval restrictions that would coincide intervals that you are already required consider differences in feedstock; best with your operation, and then to, or voluntarily, apply. For example, if application methods; and treatment purchase or treat a biological soil you are a USDA-certified organic methods, especially given the potential amendment of animal origin that meets grower, and utilize a 120-day for new innovations in such methods. In application interval for the use of raw the corresponding specifications (i.e., any such case, as discussed below, we the first column in the table in manure as part of participation in the propose in § 112.60(b)(5) that you § 112.56(a)). For example, if you intend National Organic Program, the proposed establish and keep documentation of the to apply a side-dress of a biological soil 9-month application interval scientific data and information you are amendment of animal origin close to requirement in § 112.56(a)(1)(i) would relying on to support the use of an harvest, you would find be concurrent, not consecutive, with the alternative minimum application § 112.56(a)(1)(ii), (2), (3), and (4)(ii) have 120 days. Thus, your use of a 9-month interval. We do not propose that you no minimum application interval. You application interval for raw manure would be required to submit such data would accordingly either use a would satisfy both this proposed rule and information to us for prior approval; controlled physical or chemical process and the requirements of the National we do, however, propose the that meets the requirements of Organic Program. As another example, if requirement that you maintain a record § 112.54(a) and have no further you plan to apply a biological soil of any such data and information for us restrictions, use a controlled physical or amendment of animal origin to a field to evaluate upon request. chemical process that meets the less of spinach that is nearing harvest for stringent microbial standards of fresh market consumption, assuming the h. Records Requirements § 112.54(b) if you can apply the treated spinach is reasonably likely to contact Proposed § 112.60(a) requires that you biological soil amendment of animal the soil after application of the soil establish and keep records for subpart F origin in a manner that minimizes amendment, you could select a in accordance with the requirements of potential for contact with the covered biological soil amendment of animal subpart O of this part. Proposed produce during and after application, or origin that is heat-treated to meet the § 112.60(b) would establish use composted or untreated biological standards presented in § 112.54(b) (e.g., requirements for records you must soil amendments of animal origin if you chicken manure pellets), provided that establish and keep regarding biological can apply them in a manner that you can apply it in a manner that soil amendments of animal origin that ensures they do not contact covered minimizes the potential for contact with you use. Proposed § 112.60(b)(1) would produce during or after application (for covered produce during and after require documentation of the date of example, if you are growing tree crops application (e.g., used as a side- application of any untreated biological such as oranges, you apply the dressing), because there would not be an soil amendment of animal origin untreated soil amendment without application restriction interval with that (including raw manure) or any causing it to contact the oranges, and type of biological soil amendment of biological soil amendment of animal you do not harvest oranges that have animal origin. If you plan to use manure origin treated by composting to a been allowed to come into contact with as a biological soil amendment of growing area and the date of harvest of the soil after application of the soil animal origin for the same crop and covered produce from that growing area, amendment). Conversely, you may plan to apply the amendment before except when covered produce does not determine which application method planting, and do not wish to utilize a contact the soil after application of the and interval is most appropriate by treatment such as described by soil amendment. These records would evaluating which specification your § 112.54(a) or (b), you would choose to be required because the application of biological soil amendment of animal compost the soil amendment to meet the both raw manure and compost include origin meets, and then apply it requirements of § 112.54(c). Use of such minimum application intervals according to the coinciding application a biological soil amendment of animal (§ 112.56(a)(1)(i) and (4)(i), method and interval restrictions. If, for origin would only be restricted to respectively), so it would enable FDA to example, you wish to apply raw manure application in a manner that minimizes verify compliance with the application to your field, you would find the the potential for contact with covered intervals associated with raw manure

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and compost. These records would also level of control over your supplier’s proposed subpart F and satisfies the allow you to keep track of the dates on process of treating a biological soil requirements of proposed § 112.12. which those biological soil amendments amendment of animal origin as you Finally, we seek comment on an issue of animal origin were applied in order would have if you were to apply the that is not explicitly addressed in our to determine when covered produce treatment process on-farm, where you proposed provisions. Biological soil from those growing areas could be would be able to monitor the process amendments (including agricultural teas harvested in compliance with the rule. controls yourself. You would not be derived from biological materials) are USDA-certified organic growers who required to perform any treatment nutrient rich and may support rapid and already maintain records of when processes on a biological soil prolific growth of human pathogens, if biological soil amendments of animal amendment of animal origin that you pathogens are present. Seeds used for origin are applied in compliance with 7 purchase and for which you have the sprouting have repeatedly been CFR 205.103 would not need to appropriate documentation showing it demonstrated to have the potential to be duplicate those records to meet the has already been treated by a validated contaminated with human pathogens requirements of § 112.60(b)(1). process in accordance with § 112.55. and cause human illnesses. We note that Proposed § 112.60(b)(2) would require These records would also allow you to the National Organic Standards Board documentation (such as a Certificate of ensure that a treated biological soil Compost Tea Task Force recommended Conformance) for a treated biological amendment that you purchase from a not allowing for the use of ‘‘compost soil amendment of animal origin that third party meets the requirements of tea’’ for the production of edible seed you receive from a third party. We have this proposed rule and to determine the sprouts (Ref. 36). We are concerned that tentatively concluded that the relevant application restrictions you using a biological soil amendment information you will need both to verify must apply to such a soil amendment. (including agricultural teas derived from that any biological soil amendment of Proposed § 112.60(b)(3) would require biological materials) could increase the animal origin you purchase for use in documentation that process controls (for likelihood of rapid and prolific growth performing a covered activity is in example, time, temperature and of human pathogens, if present, during compliance with this subpart F, and to turnings) were achieved for any treated sprout growing. We request comment on inform your decisions on further biological soil amendment of animal whether sprouters currently use handling, conveying, and storing of the origin you produce for your own biological soil amendments (including purchased biological soil amendment of covered farms. This documentation is agricultural teas made from biological animal origin, includes the following: (i) required to verify that the treatment or materials, such as ‘‘compost teas’’) in The process used to treat the biological treatments you performed were properly the growing of sprouts. In addition, we soil amendment of animal origin is a carried out. For example, such records request comment on the likelihood of scientifically valid process that has been would inform you of any breakdown in contamination presented by such a carried out with appropriate process the process or treatments, how they practice and whether the practice monitoring; (ii) the applicable treatment occurred or can be corrected, and create should be prohibited. process is periodically verified through a history to help you predict and G. Subpart G—We Have Tentatively testing using a scientifically valid prevent any future breakdowns. Without Reserved Subpart G of This Proposed analytical method on an adequately such records, you would not be able to Rule representative sample to demonstrate ensure, and we would not be able to H. Subpart H—We Have Tentatively that the process satisfies the applicable verify, that the process or treatment you Reserved Subpart H of This Proposed microbial standard in § 112.55, performed achieved the required Rule including the results of such periodic parameters that are validated to meet testing; and (iii) the biological soil the microbial standards of § 112.55 or I. Subpart I—Standards Directed to amendment of animal origin has been that the alternatives that you are using Domesticated and Wild Animals handled, conveyed and stored in a (if applicable) satisfy the requirements As proposed, subpart I provides manner and location to minimize the of proposed § 112.12. science-based minimum standards that likelihood of contamination by an Proposed § 112.60(b)(4) would require are directed to domesticated and wild untreated or in-process biological soil documentation of scientific data or animals and are reasonably necessary to amendment of animal origin. Aspects (i) information you rely on to support any minimize the risk of serious adverse and (iii) of this proposed requirement alternative composting process used to health consequences or death from the reflect information that you would have treat a biological soil amendment of use of, or exposure to, covered produce, if you treated the biological soil animal origin in accordance with the including those reasonably necessary to amendment of animal origin on your requirements of § 112.54(c)(3). prevent the introduction of known or own farm in accordance with this Similarly, proposed § 112.60(b)(5) reasonably foreseeable hazards into proposed rule. Aspect (ii) of this would require documentation of covered produce, and to provide requirement would provide you with scientific data or information you rely reasonable assurances that the produce reasonable assurances that your supplier on to support any alternative minimum is not adulterated under section 402 of is carrying out the applicable treatment application interval in accordance with the FD&C Act. process in an effective manner such that the requirements of § 112.56(b). The the biological soil amendment of animal records described in § 112.60(b)(4) and 1. Comments Related to Proposed origin that you purchase meets the (5) would be required only if you choose Provisions applicable standards in proposed to use alternatives to those processes We received several comments in §§ 112.54 and 112.55. We tentatively presented in § 112.54(c)(1) and (c)(2) or response to the 2010 FR notice that conclude that it is appropriate to require application intervals in § 112.56(a)(1)(i) addressed issues relevant to standards this additional level of assurance from and (a)(4)(i), respectively. This directed to domesticated and wild your suppliers in order to allow FDA to documentation would be required so animals. Some comments expressed verify your compliance with these that, as necessary, we are able to verify concern about requiring measures that requirements. These requirements will that use of your alternative process prohibit the use of domesticated work also provide you with a comparable achieves the required parameters of animals on farms. Some comments

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asserted that monitoring wildlife in a kinds of animals are scarce. We LGMA (Ref. 31). We seek comment on farm environment is untenable, whereas encourage the application of practices the interactions of the proposed rule other comments recommended that we that can enhance food safety, including with the National Organic Program and prepare a list of ‘‘animals of concern’’ to sustainable conservation practices. A set opportunities to streamline compliance enable farmers to know where to target of examples of biodiversity and with both programs. preventive controls for domesticated conservation practices that may enhance We acknowledge the longstanding co- and wild animals. Some comments food safety is available from the location of animals and plant food recommended that sustainable Resource Conservation District of production in agriculture. However, as conservation practices should be Monterey County, CA (Ref. 199). This discussed in the QAR, both wild and adopted and recognized as enhancing proposed rule would not require the domestic animals may be a source of food safety. Several comments noted destruction of habitat or the clearing of human pathogens. In fact, domesticated that farmers are subject to State and farm borders. Instead, we propose to animals, due to their close proximity Federal laws regarding wildlife (e.g., require you to monitor those areas that and interaction with humans, are Endangered Species Act and Clean are used for a covered activity for generally more likely to harbor zoonotic Water Act) and that there are programs evidence of animal intrusion when, pathogens than are wild animals (Ref. that emphasize environmental under the circumstances, there is a 200). Therefore we tentatively conclude stewardship (e.g., National Organic reasonable probability that animals will that measures should be taken to Program and programs of the Natural contaminate covered produce. minimize the likelihood of covered Resources Conservation Service). Others produce being contaminated by excreta 2. Proposed Requirements expressed concern about any from grazing and working animals. The requirements that would lead to Proposed subpart I includes standards likelihood of contaminating fresh destruction of habitat or clearing of farm that would be directed to the potential produce with human pathogens from borders. for biological hazards from animal excreta from grazing and working This proposed rule would not excreta to be deposited by your own animals is determined by numerous prohibit the use of on-farm domesticated animals (such as livestock, factors, including but not limited to the domesticated working animals. Rather, working animals, and pets), by species of the animal, the number of this proposed rule would require you to domesticated animals from a nearby animals per unit area of land, agro- take measures to prevent the area (such as livestock from a nearby ecological conditions, and the time introduction of known or reasonably farm), or by wild animals (such as deer period between animal grazing or foreseeable hazards into or onto covered and wild swine) on covered produce or working in fields and the harvest of produce, if you use working animals in in an area where you conduct a covered fresh produce (Ref. 176. Ref. 169. Ref. a growing area where a crop has been activity on covered produce. Proposed 201. Ref. 202). planted and when, under the subpart I would not be directed to the Proposed § 112.81(a) would establish circumstances, there is a reasonable potential for biological hazards from that the requirements of proposed probability that animals will manure that may be used as a soil subpart I apply when a covered activity contaminate covered produce. We amendment; such requirements directed takes place in an outdoor area or a disagree with comments that asserted to biological soil amendments of animal partially-enclosed building and when, that monitoring for animal intrusion is origin are discussed in section V.F of under the circumstances, there is a untenable. Periodic monitoring for this document. reasonable probability that animals will animal intrusion and deposition of their Consistent with sections 419(a)(1)(A), contaminate covered produce. We have excreta is a necessary measure to 419(a)(3)(E), and 419(a)(3)(D) of the Act, tentatively concluded that measures prevent contamination of covered we consulted with USDA’s National directed to domesticated and wild produce with biological food safety Organic Program and Natural Resources animals (such as cows, swine, and deer) hazards when there is a reasonable Conservation Service, U.S. Fish and are necessary when a covered activity probability that animals will Wildlife Service, and the EPA (Ref. 115) takes place in an outdoor area or a contaminate covered produce. We to ensure that environmental and partially-enclosed building if, under the consider that monitoring during the conservation standards and policies circumstances, there is a reasonable growing season and immediately prior established by those agencies are probability that animals will to harvest is a practical and minimum appropriately considered in developing contaminate covered produce, because necessary standard to sufficiently the requirements proposed in this it is reasonably likely that such animals ensure that any potential hazards subpart. Based on these consultations, will encroach on such areas and deposit related to animal intrusion are we tentatively conclude that the excreta on covered produce or food identified for appropriate follow-up provisions of proposed subpart I do not contact surfaces. Some human actions in these situations. Proposed conflict with or duplicate the pathogens of public health concern (e.g., § 112.83 is intended to provide you with requirements of the National Organic E. coli O157:H7) that have been information about animal movements Program. In addition, also based on associated with produce foodborne on your farm, allow you to recognize these consultations, we tentatively outbreaks are zoonotic, meaning that significant intrusion, and facilitate your conclude that the provisions of they may originate from animals as well taking appropriate measures following proposed subpart I are consistent with as humans. Therefore, animals, both significant animal intrusion. existing conservation and wild and domestic, may be a source of While we recognize the value of environmental practice standards and human pathogens during the growing, establishing a list of ‘‘animals of policies while providing for enforceable harvesting, packing and holding of concern,’’ we tentatively conclude that public health protection measures. covered produce. We expect this current scientific evidence on the extent Furthermore, the provisions in proposed provision to provide flexibility for to which specific animals present the subpart I are consistent with current farmers to consider the nature of greatest risk for pathogens is inadequate recommendations in our GAPs Guide covered produce and covered activities to develop such a list. Moreover, data on (Ref. 10), the AFDO Model Code (Ref. (including characteristics of covered regional and seasonal variations in the 20), Commodity-specific industry produce) in light of the potential for prevalence of pathogens in different guidances (Ref. 44. Ref. 46), and the contamination, and determine whether

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the proposed requirements of subpart I association with human or domesticated harvested, such as when it is not would be applicable under the animal activity or waste (Ref. 199). A possible to effectively avoid the harvest circumstances. For example, in the case suitable time period based on these and of covered produce that was directly of covered produce that grows other relevant factors must be exposed to animal excreta or that may completely underground, we expect that established for the purpose of reducing, be cross-contaminated during harvest there would not be a reasonable via die-off, pathogen levels in the (e.g., contamination of covered produce probability of contamination of covered excreta that may be transferred to by contact with a food-contact surface produce by domesticated or wild covered produce. We would not expect that contacted animal excreta), as animals that may graze on or encroach it to be necessary for such time periods provided for in proposed § 112.112. into fields. The proposed requirements to exceed 9 months, which is the Monitoring throughout the growing in §§ 112.82 and 112.83, therefore, application interval we propose for use season may assist you in developing an would not apply to covered activities of raw manure as a soil amendment in understanding of when and the degree taking place in an outdoor area or a proposed § 112.56(a)(1)(i). to which animal intrusion occurs partially-enclosed building when such Proposed § 112.82(b) would require throughout the production season from activities relate to covered produce that that, if you use working animals in a planting to harvest. This proposed grows completely underground. We growing area where a crop has been provision should not be construed to note, however, that we do not intend the planted, you must take measures to require the ‘‘taking’’ of an endangered phrase ‘‘under the circumstances’’ in prevent the introduction of known or species, as the term is defined in the these proposed requirements to suggest reasonably foreseeable hazards into or Endangered Species Act (16 U.S.C. that farms alter their surrounding onto covered produce. For example, if 1532(19)) (i.e., to harass, harm, pursue, environment in order to reduce the you use draft horses as working animals hunt, shoot, wound, kill, trap, capture, chances of animal intrusion, such as by in your covered produce fields, you or collect, or to attempt to engage in any clearing farm borders around outdoor could establish and use horse paths such conduct), or to require farms to growing areas or drainages. This which are segregated from covered take measures to exclude animals from proposed rule is not intended to require produce plantings, and minimize entry outdoor growing areas or destroy animal such actions. We intend the phrase of the horses into covered produce habitat or otherwise clear farm borders ‘‘under the circumstances’’ to refer to plantings, thus minimizing the around outdoor growing areas or the nature of the covered produce (such opportunity for horse excreta to contact drainages. as its growth habit) and the nature of covered produce or food contact covered activities (such as the manner surfaces. J. Subpart J—We Have Tentatively in which working animals are used in Proposed § 112.83 would establish Reserved Subpart J of This Proposed growing areas). We request comment on requirements for measures related to Rule this issue. animal intrusion in those areas that are K. Subpart K—Standards Directed to Proposed § 112.81(b) would provide used for covered activities for covered Growing, Harvesting, Packing, and that the provisions of proposed subpart produce when under the circumstances Holding Activities I would not apply to fully enclosed there is a reasonable probability that buildings. We tentatively conclude that animal intrusion will contaminate As proposed, subpart K discusses the measures proposed in this section covered produce. We are proposing to science-based minimum standards directed to domesticated and wild require that you monitor these areas as directed to growing, harvesting, animals (such as cows, dogs, swine, and needed throughout the growing season, packing, and holding activities that are deer) are not necessary when a covered based on the covered produce being reasonably necessary to minimize the activity takes place in a fully-enclosed grown and your observations and risk of serious adverse health building. Rather, we propose measures experiences (proposed § 112.83(a)(1)(i) consequences or death from the use of, directed at domesticated and wild and (ii)), and immediately prior to or exposure to, covered produce, animals (such as horses, dogs, and harvest (proposed § 112.83(a)(2)). In including those reasonably necessary to rodents) in a fully-enclosed building in proposed § 112.83(b) we would also prevent the introduction of known or proposed § 112.127 (see section V.L. of require that, if animal intrusion occurs, reasonably foreseeable hazards into this document). as evidenced by observation of covered produce, and to provide Proposed § 112.82 would establish significant quantities of animals, animal reasonable assurances that the produce requirements for measures that you excreta or crop destruction via grazing, is not adulterated under section 402 of must take, at a minimum, if you allow you must evaluate whether the covered the FD&C Act. animals to graze or use them as working produce can be harvested in accordance 1. Comments Relevant to the Proposed animals in fields where you grow with the requirements of proposed Provisions covered produce and under the § 112.112. circumstances there is a reasonable We acknowledge that when covered We received some comments in probability that grazing or working produce is grown in an outdoor response to the 2010 FR notice that animals will contaminate covered environment, wild animals are likely to addressed the adequacy and cleanliness produce. Proposed § 112.82(a) would have access to production fields. The of food-packing material and requested require you to implement an adequate presence of animals in a production that reusable containers be allowed in waiting period between grazing and field of covered produce, in and of packing produce commodities. time of harvest for covered produce in itself, is not a significant food safety It is important to ensure that food- any growing area that was grazed, to risk. However, wild animals are known packing material that is used in covered ensure the safety of the harvested crop. zoonotic disease reservoirs for human activities is adequate for its intended The potential likelihood of animals to pathogens, and therefore their excreta use, including that it is clean. In act as vectors of human pathogens is may contaminate growing covered proposed § 112.116 below, we address determined by several factors, including produce crops (Ref. 169. Ref. 203). the adequacy and cleanliness of food- but not limited to the type of Monitoring immediately prior to harvest packing material. Specifically, proposed commodity (as discussed above), and will enable you to identify instances § 112.116(b) would require that if you the species of the animal and its when covered produce cannot be safely reuse food-packing material, you take

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measures to ensure that food-contact up by the food-contact surface from contamination. Washing is an attractive surfaces are clean, such as by cleaning excluded produce are not transferred to option because it effectively removes and sanitizing, when necessary, food- covered produce. excess dirt, debris, and other organic packing containers or using a clean Proposed § 112.112 would require you matter and its use incurs a relatively liner. to take all measures reasonably low cost allowing it to be employed necessary to identify, and not harvest, 2. Proposed Requirements across a variety of equipment (water covered produce that is reasonably flumes, hydrocoolers, dips, scrubbers, Proposed § 112.111 would establish likely to be contaminated with a known sorters, etc.) or steps in combination, or that if you grow, harvest, pack or hold or reasonably foreseeable hazard, in sequence before packaging. Despite produce that is not covered in this part including steps to identify and not these advantages, a number of studies (i.e., excluded produce in accordance harvest covered produce that is visibly have concluded that wash water, with with § 112.2) and also conduct such contaminated with animal excreta. For or without an active antimicrobial agent, activities on covered produce, and the example, you would comply with this does not completely disinfect produce excluded produce is not grown, provision by not harvesting a head of that may contain microorganisms of harvested, packed or held in accordance lettuce if you see evidence of bird public health significance (Ref. 206. Ref. with this part, you must take measures excreta on the head of lettuce. As 210. Ref. 209). Wash water containing during these covered activities, as discussed in the QAR, it is well an antimicrobial such as chlorine is applicable, to: (a) Keep covered produce established that animal excreta is a reported to reduce microbial separate from excluded produce source of pathogens. Transmission of populations by two or three log units (proposed § 112.111(a)); and (b) pathogens from animal excreta to (100 to 1000 fold), but does not Adequately clean and sanitize, as covered produce and, subsequently, to eliminate microbes (Ref. 211. Ref. 210). necessary, any food-contact surfaces humans through consumption is Bacteria may find harborage and that contact excluded produce before reasonably likely in cases where the protection on plants through using such food-contact surfaces for presence of animal excreta can be hydrophobic areas, stomata, lenticels, covered activities on covered produce visually confirmed. Therefore, if the punctures, and bruises and where it is (proposed § 112.111(b)). As discussed in presence of animal excreta in a field of not readily washed off (Ref. 212. Ref. the QAR, raw produce may have a covered produce precludes your ability 213). Of special significance to bacterial variety of microorganisms in and on it, to safely harvest the covered produce, survival on plants are circumstances including, occasionally, human either because a significant portion of that lead to bacterial cells being drawn pathogens. The types of the covered produce has animal excreta in or internalized inside the edible microorganisms, including human on it or because the animal excreta that portion of the plant where they may pathogens, detected on raw produce are is present would be likely to escape the action of water altogether. diverse and may often be found in high contaminate food contact surfaces of This phenomenon, termed numbers (Ref. 204. Ref. 205. Ref. 206). harvest equipment, you must not internalization, may occur as a In addition, some human pathogens that harvest the relevant portions of that consequence of temperature are commonly isolated from the growing field. differentials created when warm environment (e.g., L. monocytogenes) Proposed § 112.113 would require produce (from field heat or daytime are reported to adapt and survive in the that you handle harvested covered high temperatures) is submerged in food production environment (e.g., food produce during covered activities in a cooler water. Under these conditions, contact surfaces, floors, walls, drains, manner that protects against infiltration of water occurs because sinks, standing water, and seals) and, contamination with known or intercellular air spaces within fruits and thus, pose a potential source of reasonably foreseeable hazards, for contamination (Ref. 207). The proposed example, by avoiding contact of cut vegetables contract, thereby creating a standards included in this part are surfaces of harvested produce with soil. partial pressure differential that draws designed to reduce the likelihood that As discussed in the QAR, research the water into the internal human pathogens are present in or on demonstrates that soil microorganisms, compartments of the plant. If the covered produce. For this reason, including human pathogens, may cooling water contains human excluded produce that is not grown, effectively colonize produce when the pathogens the fresh produce item will harvested, packed and stored in produce has lost its protective covering now be internally contaminated. This accordance with the standards proposed (e.g. cuticle) in the course of harvest phenomenon has been seen with in this part is likely to present a greater activities (e.g., cutting or trimming) or Salmonella and E. coli O157:H7 in likelihood of contamination with when damaged during such operations tomatoes, oranges, or mangoes (Ref. 138. human pathogens than would covered (Ref. 208. Ref. 209). Once established, Ref. 139. Ref. 214). As part of a post- produce that is grown, harvested, the high moisture content of produce outbreak study, Penteado et al. 2004 packed, and held in accordance with provides a suitable environment for reported evidence that Salmonella spp. this part. We tentatively conclude that survival and growth of such pathogens. may have internalized in fresh mangoes for operations handling both covered Pathogens, if present, may be transferred during a postharvest cooling step and excluded produce, cross- to cut surfaces of harvested produce involving a water bath (Ref. 38). We contamination is reasonably likely in from soil and, therefore, preventing seek comment on whether we should the absence of measures directed toward unnecessary contact between such cut consider washing, alone or in its prevention. Such measures include surfaces and soil will reduce the combination with other measures, as a separation of the two types of produce likelihood of such transfer. For example, requirement to reduce the likelihood of to avoid physical contact and any you could take steps to temporarily contamination. transfer of pathogens from one to the place cut lettuce heads on clean Proposed § 112.114 would prohibit other; and cleaning and sanitizing, as cardboard or other clean surface during you from distributing covered produce necessary, food contact surfaces used on field packing, rather than placing them that drops to the ground before harvest such excluded produce before those directly on the soil. (dropped covered produce) unless it is surfaces come in contact with covered We considered washing as a exempt under § 112.2(b) (i.e. if it produce so that any pathogens picked requirement to reduce the likelihood of receives commercial processing to

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adequately reduce the presence of the nature of the commodity itself. If reached that presents a risk for C. microorganisms of public health specific commodities should be botulinum toxin formation or use of significance). Dropped covered produce exempted from this provision, please antimicrobial compounds (Ref. 224). We does not include root crops (such as explain the practices, processes, and request comment on the need for this carrots) that grow underground or crops conditions associated with that proposed provision and on the types or (such as cantaloupe) that grow on the commodity that would justify such conditions of modified or reduced ground. However, produce that grows exemption. We expect that this oxygen packaging methods that may or off the ground, such as tomatoes and proposed provision would prevent the may not increase the risk of formation apples, and that drop to the ground marketing for fresh use of produce that of botulinum toxin. before harvest would be considered may have been bruised as a result of the Proposed § 112.116 would establish dropped covered produce. Evidence fall. As noted above, damaged or measures that you must take when using from studies of tree fruit (e.g., apples bruised fruit provide an opportunity for food-packing (including food packaging) and pears) indicates that dropped and pathogen intrusion into the edible material. Specifically, proposed damaged fruit contain coliform bacteria portion and may liberate nutrients for § 112.116(a) would require that food- in significantly higher numbers than pathogen growth. We note that produce packing material must be adequate for intact tree fruit (Ref. 215). Risk that is intentionally dropped to the its intended use. For example, food- assessment models for apple ground as part of the harvesting method packing material that would be adequate contamination (Ref. 216) show that would not be considered ‘‘dropped for its intended use include plastic bins dropped apples are more likely to be covered produce’’ as defined in for holding fresh-picked fruit, wax- impregnated corrugated cardboard for contaminated with bacteria than tree- proposed § 112.114 (i.e., produce that broccoli to be hydrocooled or top-iced picked apples, and dropped fruit used drops to the ground before harvest). We after packing, plastic clamshells used in the production of apple products seek comment on whether proposed for packaging strawberries for retail sale, (e.g., apple cider) are likely to increase § 112.114 adequately takes into account and single-use cardboard containers for rates of product contamination (Ref. produce that is intentionally dropped packing tomatoes. Wooden bins or 216). While data available to us is during harvesting and whether such boxes, and canvas bags that may be used primarily derived from studies harvesting practices do not cause during harvest also would need to meet investigating apples, we tentatively damage to the produce. Proposed this requirement, and could be used if conclude that all dropped covered § 112.115 would establish measures that produce is likely to present a potential they are adequately clean and sanitary you must take when packaging covered for their intended use. To implement likelihood for contamination, although produce. Specifically, proposed to varying degrees. Studies have this provision, you would have to use § 112.115 would require that you food-packing materials that are: (1) indicated that when produce drops to package covered produce in a manner the ground, the produce can become Cleanable or designed for single use and that prevents the formation of (2) unlikely to support growth or structurally damaged, which is Clostridium botulinum toxin, if such considered to be a factor for transfer of bacteria. In addition, toxin is a known or reasonably proposed § 112.116(b) would require proliferation of human pathogens on foreseeable hazard (such as for such produce (Ref. 217. Ref. 218. Ref. that if you reuse food-packing material, mushrooms). The potential for toxin you take measures to ensure that food- 219). Excluding dropped fruit from production by C. botulinum in contact surfaces are clean, such as by harvest is also recommended in some mushrooms packaged under reduced cleaning and sanitizing, when existing guidance documents (Ref. 220. oxygen conditions is well-known (Ref. necessary, food-packing containers or Ref. 221. Ref. 44). However, some 222). Mushrooms grow close to the using a clean liner. Evidence from produce is dropped to the ground as a ground, which is a source of C. scientific literature indicates that the part of the harvesting practice (e.g., botulinum spores. Mushrooms remain number of microorganisms detected on some tree nuts). We expect that such metabolically active after harvest, which the surface of fruits is directly correlated harvesting practices were developed may quickly reduce the amount of to the amount of contact time between because the fall does not damage the oxygen, particularly when mushrooms the fruit commodity and its packing edible crop, because the crop is are packaged under conditions that limit material (Ref. 226. Ref. 227). Although protected with a durable shell. the transfer of oxygen across the layer of some food-packing material is Accordingly, we have defined ‘‘dropped packaging (Ref. 223). In such reduced sufficiently sturdy to be used multiple covered produce’’ to exclude produce oxygen or anoxic conditions, C. times, it may serve as a source of that is intentionally dropped as part of botulinum spores can germinate contamination in the absence of regular harvesting. Further, we do not propose resulting in the formation of botulinum cleaning and sanitizing between each to prohibit the use of dropped covered toxin, which can occur before any overt such use. Further, certain food-packing produce in a commercial process (e.g., signs of mushroom spoilage (Ref. 222). material may have a serviceable shelf canning) that is designed to adequately Modified or reduced-oxygen packaging life beyond which it may not possible to reduce the presence of microorganisms of other produce may present a similar effectively clean and sanitize the of public health significance. Therefore, risk for botulinum toxin formation (Ref. material. It is reasonably likely that such dropped covered produce that is exempt 224). Perforated packaging film allows packing material, if it continues to be under proposed § 112.2(b) may be free air access to mushrooms and is used, may serve as harborage sites for distributed for such commercial recommended as a means to reduce the pathogens, if they become established processing as described in proposed potential for toxin formation in on its surface. § 112.2 (see section V.A. of this mushrooms (Ref. 225). Other means of document). preventing toxin formation in modified L. Subpart L—Standards Directed to We seek comment on this provision or reduced oxygen packaging may Equipment, Tools, Buildings, and and whether specific commodities include use of time-temperature Sanitation should be exempted from this provision integrators on individual packages of Proposed subpart L establishes based on the harvesting practices produce to signal when a cumulative science-based minimum standards that associated with the commodity and/or time-temperature combination has been are reasonably necessary to prevent

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equipment, tools, buildings, and would be subject to proposed subpart L. mechanical polishing to facilitate inadequate sanitation from introducing In addition, instruments or controls cleaning and sanitizing the tool would known or reasonably foreseeable used to measure, regulate, or record enhance food safety (Ref. 230). hazards into or onto covered produce or conditions to control or prevent the Proposed § 112.123(b)(1) would food-contact surfaces, and to provide growth of undesirable microorganisms establish that equipment and tools you reasonable assurances that the covered or other contamination would be subject use must be installed and maintained in produce is not adulterated under section to proposed subpart L. In proposed a manner that facilitates cleaning of the 402 of the FD&C Act. § 112.121, we provide examples of such equipment and of all adjacent spaces. A few comments recommended that equipment and tools, i.e., knives, For example, equipment that is equipment used to hold or convey water implements, mechanical harvesters, permanently installed in an on-farm should be inspected to ensure that it is waxing machinery, cooling equipment packing operation would need to be clean. (including hydrocoolers), grading belts, installed in such a manner that both We agree that equipment used to hold sizing equipment, palletizing maintenance and cleaning crews are or convey water should be maintained equipment, and equipment used to store able to easily access any food contact in a manner necessary to protect against or convey harvested covered produce surfaces, protective covering or barriers, contamination. In 112.42 (b), we would (such as containers, bins, food-packing and any movable parts or other potential require that you must adequately material, dump tanks, flumes, and sources of contamination. A conveyor maintain all agricultural water sources vehicles or other equipment used for belt system that is part of a grading line that are under your control (such as transport). would be considered properly installed wells) by regularly inspecting each Proposed § 112.122 would identify if there is easy access to the belt (a food- source and keeping the source free of the types of buildings that are subject to contact surface) for cleaning. The debris, trash, domesticated animals, and the requirements of proposed subpart L. proposed provisions in § 112.123(b)(1) other possible sources of contamination Such buildings would include any fully- are consistent with the requirements in of covered produce to the extent or partially-enclosed buildings used for current § 110.40(a) and § 111.27(a). practicable and appropriate under the covered activities, including minimal Proposed § 112.123(b)(2) would circumstances. In 112.42 (c), we would structures that have a roof but do not establish that equipment and tools you require that you must adequately have any walls (proposed § 112.122(a)). use must be stored and maintained to maintain all agricultural water Fully-enclosed buildings are typically protect covered produce from being distribution systems as necessary and used to grow covered produce such as contaminated with known or reasonably appropriate to prevent the water sprouts and mushrooms and may be foreseeable hazards and to prevent the distribution system from being a source used to grow a variety of covered equipment and tools from attracting or harboring pests. As discussed in the of contamination to covered produce, produce indoors to create or extend the QAR, if farm equipment or tools are food-contact surfaces, areas used for a growing season in a particular stored outside or in a partially-enclosed covered activity, or water sources, geographic area. Partially-enclosed building, they may attract or harbor including by regularly inspecting and buildings can be used to grow covered pests, which can carry human adequately storing all equipment used produce such as tomatoes, and are often pathogens (Ref. 231). Appropriate in the system. used to pack covered produce. Buildings that are subject to the practices for storing and maintaining 1. Comments Relevant to Proposed requirements of the rule would also equipment and tools can reduce the Provisions include storage sheds, buildings, or potential for these problems. For We received some comments in other structures used to store food- example, you would comply with this provision by storing equipment and response to the 2010 FR notice that contact surfaces (such as harvest tools indoors when practical, and when expressed that the use of animals on a containers and food-packing materials) not practical, minimizing surrounding farm or their presence near farming (proposed § 112.122(b)). We are debris and checking periodically for operations should not be prohibited. proposing this requirement because pests. We address issues related to animals contaminated food-contact surfaces can contaminate covered produce (Ref. 182) Proposed § 112.123(c) would establish in and around farming operations in that seams on food-contact surfaces of subpart I (see section V.I. of this (Ref. 228) and, thus, present a potential hazard. equipment and tools that you use must document) of this rule. However, in this be either smoothly bonded, or subpart, we address the presence of b. General Requirements Applicable to maintained to minimize accumulation animals in fully-enclosed buildings. Equipment and Tools of dirt, filth, food particles, and organic Specifically, proposed § 112.127 would As proposed, § 112.123 establishes material and thus minimize the require that you take reasonable general requirements applicable to opportunity for harborage or growth of precautions to prevent domesticated equipment and tools subject to subpart microorganisms. This provision is animals, including guard and guide L. Proposed § 112.123(a) would require consistent with current § 110.40(a) and dogs, in and around a fully-enclosed you to use equipment and tools that are (b) and § 111.27(a). building from contaminating covered of adequate design, construction, and Proposed § 112.123(d)(1) would produce, food-contact surfaces, and food workmanship to enable them to be require you to inspect, maintain, and packing materials with known or adequately cleaned and properly clean and sanitize (when necessary and reasonably foreseeable hazards. maintained. For example, some lettuce appropriate) all food-contact surfaces of 2. Proposed Requirements coring knives currently used in the equipment and tools used in covered industry are designed in a way that activities as frequently as reasonably a. Equipment, Tools, and Buildings That gives them the propensity to transfer necessary to protect against Are Subject to the Requirements of This microbial contaminants from soil to the contamination of covered produce. This Subpart lettuce (Ref. 229). Using a tool that is provision is intended to prevent transfer Any equipment and tools used during designed to minimize the potential for of contaminants on food-contact covered activities that are intended to, pathogen transfer from soil to the surfaces of equipment or tools (e.g., or likely to, contact covered produce produce and/or that allows for harvest knives, grading belts, or harvest

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bins) to covered produce. As discussed highlighted in our GAPs Guide (Ref. 10). adequate for use in transporting covered in the QAR, for example, it has been We seek comment on the produce. Transport equipment that is documented that E. coli O157:H7 can be appropriateness of the proposed intended to, or likely to, contact covered transferred to Iceberg lettuce from cleaning provisions related to produce that is not clean, or that is not contaminated coring devices used in a equipment and tools. adequate for the covered produce it is simulated field coring (Ref. 229). Even being used to transport, can be a source c. General Requirements Applicable to food contact surfaces made of stainless of cross-contamination of covered Instruments and Controls steel can transfer pathogens to covered produce. Equipment used to transport produce, if not properly cleaned and Proposed § 112.124 would establish covered produce would not be sanitized. For example, transfer of that instruments or controls you use to adequately clean if, for example, there is pathogens from stainless steel tools to measure, regulate, or record dirt, filth, organic material, particles of lettuce has been demonstrated to occur temperatures, hydrogen-ion food, remains of previous shipping to various extents, depending on the concentration (pH), sanitizer efficacy or loads, or any other extraneous materials amount of water on the leaf surface (Ref. other conditions, in order to control or or contaminants on surfaces that are 232). prevent the growth of pathogens or likely to come into contact with the Proposed § 112.123(d)(2) would other contamination, must be: (a) produce. Equipment used to transport require you to maintain and clean all Accurate and precise as necessary and covered produce would not be adequate non-food-contact surfaces of equipment appropriate in keeping with their if, for example, the same equipment is and tools subject to subpart L used in purpose; (b) adequately maintained; and used to haul live animals or garbage that covered activities during harvesting, (c) adequate in number for their is not completely contained, and the packing, and holding as frequently as designated uses. Proposed § 112.124 is equipment is either not designed in a reasonably necessary to protect against consistent with current § 111.27(a)(6), manner that allows cleaning and contamination of covered produce. The and similar to requirements in current sanitizing or it is not cleaned or potential for an equipment or tool to § 110.40(f). Accuracy addresses whether sanitized, before it is used to transport come into contact with covered produce the recorded measurements are equal to covered produce. Proposed § 112.125 is varies with the type and intended use of the true value of that which is being consistent with recommendations in the equipment or tool. Non-food-contact measured, while precision addresses FDA’s GAPs Guide (Ref. 10), the AFDO surfaces of tools and equipment used in whether individual measurements are Model Code (Ref. 20), commodity- contact with covered produce can be close to each other when made under specific guidances (Ref. 85. Ref. 94. Ref. sources of contamination. Therefore, it the same conditions. Both accuracy and 27), and international guidelines (Ref. is important to maintain such surfaces precision are necessary to ensure the 96. Ref. 96). of covered equipment and tools in a validity and reliability of measurements. clean and sanitary condition. However, The appropriate degree of accuracy and e. Design and Construction such surfaces may not require cleaning precision, however, would need to be Requirements Applicable to Buildings as frequently as those that come into determined based on the nature of the Proposed § 112.126 would establish direct contact with produce, and may instrument and its specific use for the requirements applicable to the design not require sanitizing. An example of covered activity. Instruments must also and construction of buildings. As such a surface is the handle of a tool be adequately maintained to ensure that proposed, § 112.126(a) requires that used when working directly with they are functioning properly for their your buildings must be suitable in size, covered produce, although depending intended use. For example, an in-line construction, and design to facilitate on the use, such equipment or tool may water oxidation-reduction potential maintenance and sanitary operations for be or consist of a food-contact surface. meter that is used to determine the covered activities to reduce the For example, a truck used to harvest approximate sanitizer concentration in a potential for contamination of covered produce may not need to be thoroughly water flume system must be produce or food-contact surfaces with cleaned or sanitized; however, the appropriately maintained to ensure that known or foreseeable hazards. For flatbed of the same truck if used to haul there is no debris build-up that would buildings to be suitable in size, it should un-packed/loose produce would be interfere with its proper operation. In have enough room for covered activities considered a food-contact surface. addition, you must have an adequate to be conducted without cross-contact Proposed § 112.123(e) would establish number of instruments as needed for the between covered produce or food- that, if you use equipment such as designated use. For example, if you are contact surfaces and building materials, pallets, forklifts, tractors, and vehicles composting a small pile of manure and non-food-contact surfaces, or clothing. such that they are intended to, or likely monitoring the temperature, one Proposed § 112.126(a)(1) would to, contact covered produce, you do so thermometer may be sufficient. establish requirements that your in a manner that minimizes the However, if you are composting large building provide sufficient space for potential for contamination of covered windrows in excess of several hundred placement of equipment and storage of produce or food-contact surfaces with yards in length, and using an automated materials. This is necessary for the known or reasonably foreseeable system to monitor the internal maintenance of sanitary operations and hazards. For example, you may consider temperature of the pile, you would need the conduct of covered activities. The the appropriate route for any equipment multiple thermocouples placed proposed provisions in § 112.126(a)(1) to move in, through, and out of throughout the pile to get a good reading are consistent with requirements in production fields, and when there may of the overall temperature. current § 110.20(b)(1) and § 111.20. be a need to visually inspect and clean Proposed § 112.126(a)(2) would such equipment to prevent d. Transport of Covered Produce establish requirements that your contamination or cross-contamination of Proposed § 112.125 would establish buildings must permit proper covered produce. The potential for that equipment subject to subpart L that precautions to be taken to reduce the transfer of contaminants from tractors to you use to transport covered produce potential for contamination of covered covered produce, for example, if the during covered activities must be: (a) produce, food contact surfaces, or tractors drive through or otherwise Adequately clean before use in packing material with known or come in contact with manure is also transporting covered produce; and (b) reasonably foreseeable hazards. The

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potential for contamination must be where covered produce, food-contact remove any nests that become reduced by effective design, including surfaces, or food-packing material is established. Any measures or steps the separation of operations in which exposed; or (2) separating domesticated taken under these provisions would contamination is likely to occur, by one animals in a fully-enclosed building need to comply with applicable wildlife or more of the following means: from an area where a covered activity is conservation regulations. Location, time, partition, enclosed conducted on covered produce by h. Toilet and Hand-Washing Facilities systems, or other effective means. This location, time, or partition. As discussed provision provides flexibility in the in the QAR, domesticated animals can Human feces may contain pathogens precautions you take for your buildings carry pathogens, potentially resulting in in relatively high concentrations (Ref. and proposes separation of operations, contamination of covered produce or 233). The most basic measure to prevent such as by having sufficient space so food contact surfaces. However, the potential transfer of pathogens from that incompatible operations can be consistent with current § 110.35(c), we human feces into or onto covered kept at a reasonable distance from each propose to permit guard or guide dogs produce and food-contact surfaces is to other, for example, so that spray coming in some areas of a fully-enclosed provide toilet facilities that collect and off equipment being washed does not building if the presence of the dogs is contain human feces. Proposed contact covered produce being packed. unlikely to result in contamination of § 112.129 would establish requirements The proposed provisions in § 112.126(a) produce, food-contact surfaces, or food- related to toilet facilities, including that are similar to requirements in current packing materials (proposed you must provide personnel with § 110.20(b)(2) and § 111.20. § 112.127(b)). You would need to take adequate, readily accessible toilet Proposed § 112.126(a)(3) would reasonable precautions to prevent facilities, including facilities readily require buildings to be constructed in a contamination of covered produce, accessible to growing areas during manner such that floors, walls, ceilings, food-contact surfaces, and food-packing harvesting activities (proposed fixtures, ducts, and pipes can be material with hazards from such dogs. § 112.129(a)). In proposed § 112.129(b), adequately cleaned and kept in good We believe that animals such as guard we propose to establish that toilet repair, and that drip or condensate does or guide dogs, when kept under control facilities must be designed, located, and not contaminate covered produce, food- and where the activities of the animal maintained to: (1) Prevent contact surfaces, or packing materials. can be contained, are unlikely to result contamination of covered produce, Buildings where covered activities in contamination of produce, food- food-contact surfaces, areas used for a occur must be suitably constructed to contact surfaces, or food-packing covered activity, water sources, and allow adequate cleaning and sanitizing materials. We seek comment on the water distribution systems with human in order to minimize the presence or appropriateness of this provision and waste (proposed § 112.129(b)(1)); (2) be persistence of hazards and the potential whether proposed provision directly accessible for servicing, be for damage or contamination of covered § 112.127(b) should be extended to all serviced and kept clean on a schedule produce. Buildings should be kept in working animals. sufficient to ensure suitability of use, good repair so as to prevent drip or and be kept supplied with toilet paper condensate from pipes or ceilings to g. Pest Control (proposed § 112.129(b)(2)); and (3) drop onto covered produce or food- As discussed in the QAR, pests such provide for the sanitary disposal of contact surfaces, and holes in walls of as rodents, snakes, lizards, turtles, waste and toilet paper (proposed enclosed buildings from permitting iguanas, and birds are known to carry § 112.129(b)(3)). These provisions are pests access to covered produce or areas human pathogens, such as Salmonella intended to contribute to an overall of covered activities. The proposed spp. and, if not controlled, can cause the sanitary measure to help protect covered provisions in § 112.126(a)(3) are contamination of covered produce, food produce and areas where covered consistent with requirements in current contact surfaces or food-packing activities are conducted from § 110.20(b)(4) and § 111.20. materials. Therefore, in proposed contamination with pathogens. A Finally, proposed § 112.126(b) would § 112.128(a), we propose to require you portable toilet facility that leaks or a establish requirements that you provide to take measures reasonably necessary fixed toilet facility that lacks proper adequate drainage in all areas where to protect covered produce, food-contact drainage or backflow devices would not normal operations release or discharge surfaces, and food-packing materials be considered properly designed or water or other liquid waste on the from contamination by pests in maintained. As discussed in the QAR, ground or floor of the building. Standing buildings, including routine monitoring runoff from such a toilet facility has the water can attract pests and support the for pests as necessary and appropriate. potential to directly contaminate growth of pathogens, such as L. Furthermore, we propose to require you covered produce, while contamination monocytogenes, presenting potential for to take measures to exclude pests from of soil and irrigation water from such contamination of covered produce. The fully-enclosed buildings (proposed runoff can have longer-lasting impact. proposed provision in § 112.126(b) is § 112.128(b)) and to prevent pests from To minimize the potential for similar to requirements in current becoming established in partially- contamination during events such as § 110.37(b)(4) and § 111.15(f)(4). enclosed buildings (such as by use of flooding or high winds, toilet facilities screens or by monitoring for the should be located away from water f. Domesticated Animals in and Around presence of pests and removing them, sources and water distribution systems, Fully-Enclosed Buildings when present) (proposed § 112.128(c)). and at a reasonable distance from Proposed § 112.127(a) would require We recognize that it might be growing and packing areas. Sewage you to take reasonable precautions to impossible to exclude pests, such as transport or other servicing trucks prevent contamination of covered birds, from entering buildings that are should have clear access to toilet produce, food-contact surfaces, and not fully-enclosed. To comply with facilities to ensure proper collection and food-packing materials in fully-enclosed proposed § 112.128(c), you would need disposal of wastes. In addition, workers buildings with known or reasonably to take those steps reasonably necessary are more likely to use toilet facilities foreseeable hazards from domesticated to prevent birds or other animals from that are clean, well-stocked, and in good animals by: (1) Excluding domesticated building nests in partially-enclosed condition (Ref. 234). We recognize that animals from fully-enclosed buildings buildings and, if possible, to find and the growing area of a farm may spread

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across several acres of land, and workers facilities during growing activities that have not been found to be effective or visitors may be in growing areas for take place in a fully-enclosed building, substitutes for washing hands with soap an extended period of time primarily and during covered harvest, packing, or and water, because the presence of dirt, during harvest activities. At times other holding activities (proposed grease, or soil reduces their than during harvest, we would consider § 112.130(a)). In addition, in proposed effectiveness in eliminating bacteria. toilet facilities to be readily accessible § 112.130(b), we would establish However, we are not proposing to if, for example, the facility is available requirements that your hand-washing prohibit the use of sanitizers as they to workers at a farm building before and facilities must be furnished with: Soap may be effective as an additional after they work in a growing area, or at (or other effective surfactant) (proposed measure in reducing the number of a nearby public facility that is readily § 112.130(b)(1)); running water that bacteria on hands after proper washing accessible to your workers. However, satisfies the requirements of § 112.44(a) with soap and water followed by drying during harvest activities we consider it for water used to wash hands (proposed The hand-washing provisions in likely that workers and visitors will § 112.130(b)(2)); and adequate drying proposed § 112.130 are consistent with spend a significant amount of time in devices (such as single service towels, recommendations in our GAPs Guide growing areas. We point out that the clean cloth towels or sanitary towel (Ref. 10), the AFDO Model Code (Ref. field sanitation requirements prescribed service) (proposed § 112.130(b)(3)). As 20), commodity-specific guidances (Ref. by the Occupational Safety and Health discussed in the QAR, hand-washing is 85. Ref. 94. Ref. 194), and international Administration (OSHA) under the a key control measure in preventing the guidelines (Ref. 96). They are also Occupational Safety and Health Act, spread of pathogens from ill or infected similar to the requirements in current specifically 29 CFR 1928.110, describes workers to covered produce and food- § 110.37(e) and § 111.15(i). the appropriate number of toilets to the contact surfaces. Workers often touch i. Disposal of Sewage, Trash, Litter, and number of workers, proper produce with their bare hands. Hand- Other Waste handwashing facilities, maximum washing, when done effectively, can As discussed in the QAR, human worker-to-restroom distance, and significantly reduce the number of feces may contain pathogens in frequency of cleaning facilities. resident bacteria on the hands of a relatively high concentrations and, Agricultural establishments subject to worker who may not be aware of being therefore, sewage must be properly the requirements of 29 CFR ill or infected, as well as transient disposed and sewage and septic systems 1928.110(c)(2), must provide one toilet microbial pathogens that get onto hands must be maintained to minimize the facility for each 20 employees or through contact with the environment potential for failure, leakage, or spills fraction thereof (except that toilet or other ill workers. The effectiveness of (and any leakage or spill appropriately facilities are not required for employees hand-washing is determined by who perform field work for a period of managed) to prevent contamination of multiple factors, including whether or covered produce. Events such as three hours or less (including not soap is used, the quality of water transportation time to and from the flooding or earthquakes also have the used, the duration of scrubbing and potential to damage sewage and septic field) during the day). rinsing, and whether and how hands are As discussed in the QAR, the fecal- systems and impair their function and, dried. The frequency of hand-washing, therefore, it would be appropriate to oral route for contamination of food as well as the efficacy of a single hand- with pathogens is well-established and assess your sewage systems for damage washing event, may also be important or other failures, following such events. proper washing and drying of hands are factors in the spread of microbial fundamental practices demonstrated to Proposed § 112.131 would establish pathogens by ill or contaminated be effective in breaking the fecal-oral requirements that apply to the control workers (Ref. 107). route of contamination. Therefore, in and disposal of sewage, including that proposed 112.129(c), we would Proposed subpart 112.130(c) would you must dispose of sewage into an establish requirements that you provide establish requirements that you provide adequate sewage or septic system or a hand-washing station during growing for appropriate disposal of waste (for through other adequate means activities that take place in a fully- example, waste water and used single- (proposed § 112.131(a)), which is enclosed building, and during covered service towels) associated with a hand- consistent with current § 110.37(c) and harvesting, packing, or holding washing facility and take appropriate § 111.15(g); you must maintain sewage activities, that is in sufficiently close measures to prevent waste water from a and septic systems in a manner that proximity to toilet facilities to make it hand-washing facility from prevents contamination of covered practical for persons who use the toilet contaminating covered produce, food- produce, food-contact surfaces, areas facility to wash their hands. We discuss contact surfaces, areas used for a used for a covered activity, agricultural the importance of hand-washing in covered activity, agricultural water water sources, and agricultural water presenting the proposed requirements sources, and agricultural water distribution systems with known or for hygienic practices in section V.D. of distribution systems with known or reasonably foreseeable hazards this document. reasonably foreseeable hazards. A hand- (proposed § 112.131(b)); you must The provisions in proposed § 112.129 washing facility produces waste that can manage and dispose of leakages or spills are consistent with recommendations in lead to contamination, and such waste of human waste in a manner that our GAPs Guide (Ref. 10), the AFDO needs to be controlled. For example, if prevents contamination of covered Model Code (Ref. 20), commodity- the sink of a portable hand-washing produce, and prevents or minimizes specific guidances (Ref. 85. Ref. 94. Ref. station in field actively being harvested contamination of food-contact surfaces, 194), and international guidelines (Ref. does not have a catch-basin or tank, but areas used for a covered activity, 96. Ref. 96). These provisions are also instead is open the ground, the waste- agricultural water sources, or similar to requirements in current water from the sink can contaminate the agricultural water distribution systems § 110.37(d) and § 111.15. soil. Finally, in proposed § 112.130(d), (proposed § 112.131(c)); and that after a With respect to hand-washing we would establish that you may not significant event (such as flooding or an facilities, we propose to require you to use hand antiseptic/sanitizer as a earthquake) that could negatively provide personnel with adequate, substitute for soap and water. As impact a sewage or septic system, you readily accessible hand-washing discussed in the QAR, hand sanitizers must take appropriate steps to ensure

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that sewage and septic systems continue that may result from inadequate periods of time (see the QAR) and may to operate in a manner that does not plumbing is improper drainage of pose a threat to water quality from contaminate covered produce, food- refrigeration drip pans. If drip pans do runoff and leaching (Ref. 236. Ref. 169), contact surfaces, areas used for a not drain properly, they may drip onto creating multiple opportunities for these covered activity, agricultural water covered produce or allow moisture to pathogens to contaminate produce or sources, or agricultural water accumulate providing an environment food contact surfaces. distribution systems (proposed that can support the establishment of l. Record Keeping § 112.131(d)). These provisions are and growth of L. monocytogenes. consistent with recommendations in our Proposed § 112.133 is intended to Proposed § 112.140(a) would make GAPs Guide (Ref. 10), commodity- ensure that your plumbing and water clear that records required under this specific guidances (Ref. 44. Ref. 46), and distribution systems do not adversely subpart L must be established and kept the AFDO Model Code (Ref. 20). affect the water you use in covered in accordance with the requirements of Proposed subpart 112.132 would activities on covered produce. If the subpart O of this part. Records required establish requirements that apply to the plumbing and water distribution to be established and kept under this control and disposal of trash, litter, and systems are not adequately installed and subpart L include documentation of the other waste in areas used for covered maintained, they may contaminate your date and method of cleaning and activities. Proposed § 112.132(a) would water supply and, in turn, contaminate sanitizing of the equipment you use in establish requirements that you convey, your covered produce through direct growing operations for sprouts store, and dispose of trash, litter and contact (such as when you use water in (proposed § 112.140(b)(1)) and in waste to: (1) Minimize the potential for irrigation or harvest activities), or covered harvesting, packing, or holding trash, litter, or waste to attract or harbor through indirect contact (such as when activities (proposed § 112.140(b)(2)). pests (proposed § 112.132(a)(1)); and (2) the contaminated water is used to wash These documentation requirements are Protect against contamination of a food-contact surface). Such cross- intended to enable us to verify and you covered produce, food-contact surfaces, contamination of clean water and waste to ensure that requirements of this areas used for a covered activity, water has been implicated in outbreak subpart are met. agricultural water sources, and investigations (Ref. 235). It would also M. Subpart M—Standards Directed to agricultural water distribution systems be important to prevent contamination Sprouts with known or reasonably foreseeable of water that must meet the hazards (proposed § 112.132(a)(2)). In requirements under subpart E by water Proposed subpart M would establish addition, we propose to require that you that does not meet the relevant science-based minimal standards for the adequately operate systems for waste requirements. For example, water used growing, harvesting, packing and treatment and disposal so that they do for irrigation of covered produce other holding of sprouts that are reasonably not constitute a potential source of than sprouts using a direct water necessary to minimize the risk of known contamination in areas used for a application method would need to meet or reasonably foreseeable hazards that covered activity (proposed § 112.132(b)). the requirements of §§ 112.41 and are associated with serious adverse The provisions proposed in § 112.132 112.44(c) or (d), but would not health consequences or death. As noted are consistent with requirements in necessarily meet the requirements of in section I of this document, sprouts current §§ 111.15(a) and (g) and similar § 112.44(a) (see section V.E. of this have been frequently associated with to requirements in current § 110.37(f). document). These provisions are foodborne illness outbreaks (Ref. 3). As These provisions are also consistent consistent with the requirements in a result, we issued our first commodity- with recommendations for packing areas current §§ 110.37(b) and 111.15(f), and specific guidance for sprouts. Likewise, in our GAPs Guide (Ref. 10), and with the recommendations in our GAPs the Codex Alimentarius Commission commodity-specific guidance (Ref. 46). Guide (Ref. 10), the AFDO Model Code supplemented its Codex Fresh Fruits and Vegetables Code with a Sprout j. Plumbing (Ref. 20), and commodity-specific guidances (Ref. 46. Ref. 44). Annex (Ref. 50). Proposed § 112.133 would establish Sprouts present a special concern that plumbing must be of an adequate k. Control of Animal Excreta and Litter with respect to human pathogens than size and design and be adequately From Domesticated Animals other covered produce because of the installed and maintained to (1) In proposed § 112.134(a), we would warm, moist, and nutrient-rich distribute water under pressure as require that, if you have domesticated conditions required to produce sprouts, needed, in sufficient quantities, in all animals, to prevent contamination of the same conditions that are also ideal areas where used for covered activities, covered produce, food-contact surfaces, for the proliferation of pathogens if for sanitary operations, or for hand- areas used for a covered activity, present (Ref. 208. Ref. 16). Therefore, we washing and toilet facilities (proposed agricultural water sources, or believe it is necessary to incorporate § 112.133(a)); (2) properly convey agricultural water distribution systems this additional subpart establishing sewage and liquid disposable waste with animal waste, you must: (1) standards specific to sprouts. The (proposed § 112.133(b)); (3) avoid being Adequately control their excreta and provisions of proposed subpart M are a source of contamination to covered litter, and (2) maintain a system for consistent with recommendations in produce, food-contact surfaces, areas control of animal excreta and litter. For FDA’s Sprout Guides (Ref. 14. Ref. 15), used for a covered activity, or example, you would comply with this industry guidance (Ref. 237), and agricultural water sources (proposed provision by not locating manure piles international regulations and guidelines § 112.133(c)); and (4) not allow backflow adjacent to packing sheds in which (Ref. 38. Ref. 191. Ref. 192. Ref. 193). from, or cross connection between, covered produce is exposed. As We are also seeking comment on piping systems that discharge waste discussed in the QAR, pathogens whether, or to what extent, the measures water or sewage and piping systems that inhabit the gut of a variety of warm- in this subpart should be applied to soil- carry water used for a covered activity, blooded animal species and are often grown sprouts. The NACMCF Sprout for sanitary operations, or for use in shed in feces in high numbers. If not White paper and our Sprout Guides do hand-washing facilities (proposed effectively controlled, such pathogens not distinguish soil-grown sprouts and § 112.133(d)). An example of a problem may persist in the environment for long hydroponic sprouts (Ref. 14. Ref. 15.

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Ref. 16). However, we are not aware of safer sprouts, citing the need for and 2002 (Ref. 239). As noted in section any outbreaks associated with sprouts addressing residual agricultural V.A.2.a. of this document, we analyzed grown in soil or media, which could be chemicals and microbial contamination consumption of selected produce because of the lower percentage of of seed, seed disinfection treatments, commodities to determine those that are sprouts grown in that manner, the worker health and hygiene, and rarely consumed raw. We included nature of the species of sprouts grown sanitation. One comment hoped that we sprouts (alfalfa and mung bean) in our in that manner, or a difference in understood the realities currently facing analysis, and based on data available likelihood of contamination posed by the sprout industry worldwide, and from the NHANES, alfalfa and mung that method and hydroponics. This would take actions to ensure truly bean sprouts do not meet our criteria for could be the case because of the relative practical measures that would be rarely consumed raw commodities (Ref. ease of transfer of pathogens between accepted by the sprout industry, 79). sprouts in a water environment and, questioning, for example, the need for 2. Proposed Requirements possibly, a greater amplification of extensive record keeping or monitoring pathogens during hydroponic sprout sprout facilities for Listeria. This Proposed § 112.141 would establish production compared to the more comment maintained that we should measures directed to seeds or beans stressful environment for pathogen consider current production methods used to grow sprouts. Seeds and beans growth posed by exposure to air and and consumption practices in used for sprouting are believed to be the sunlight when seeds are grown under establishing standards for sprouts. vehicle for contamination in most E. coli conditions more typical of a natural As discussed further in section V.M.3. O157:H7 and Salmonella foodborne setting (soil and media methods). On the of this document, our proposed rule illness outbreaks associated with other hand, we expect that seeds or carefully considers the various sprouts (Ref. 3. Ref. 16). Proposed beans would be a potential vehicle of conditions under which sprouts are § 112.141 is consistent with our Sprout contamination, regardless of sprouting grown and consumed. The proposal Guide and other public and private method employed. Seeds or beans (in provides flexibility to achieve the goal programs (Ref. 50. Ref. 240). the form of seed leaves or cotyledons) of minimizing the risk of known or Proposed § 112.141(a) would require could be part of the food consumed, reasonably foreseeable hazards that are that, if you grow seeds or beans for use regardless of the method used for associated with serious adverse health to grow sprouts, you must take measures sprouting. In addition, flats of soil or consequences or death. We consider reasonably necessary to prevent the media grown sprouts may be placed on that the proposed requirements for the introduction of known or reasonably a growing rack, similar to hydroponic growing, harvesting, packing and foreseeable hazards into or onto seeds or sprouts grown in clamshells (as opposed holding of sprouts, as well as for record beans that you will use for sprouting. to large bins for bean sprouts or rotating keeping, are all practical and necessary These measures would need to be taken drums used to start green sprouts), with to protect public health. With respect to during growing, harvesting, packing, overhead sprout irrigation water, consideration of the method of growth, and holding of seeds and beans, which providing an opportunity for pathogens, as discussed above, we are seeking include such activities as cleaning, if present, to be spread within a flat of comment on whether soil-grown sprouts conditioning, and blending. sprouts and to other flats on racks are subject to the same risk factors as Various crops may be grown to below. Alternatively, flats may be hydroponic sprouts and to whether, or produce seeds and beans for sprouting placed side-by-side in a growing area to what extent, the measures in this with different production practices, such as a greenhouse, where the subpart should be applied to them. growing seasons, conditions, and crop likelihood of pathogen spread would One comment recommended that needs. Some of these plants set seeds or presumably be lower than when a bean sprouts be subjected to less beans without intervention from growing rack is used. stringent requirements compared to growers, while others (such as alfalfa) Finally, as discussed in section IV of others, e.g., green sprouts, because bean may require steps, such as being cut- this document, while we recommend sprouts are rarely consumed raw (less back, to encourage seed set. Harvesting, that farms conduct an operational than 1% according to their estimates). packing, and holding may also vary by assessment and develop a food safety This comment suggested that seed seed type and by the conditions needed plan, at this time, we are not proposing disinfection treatments might not be to maintain seed quality, such as to require them to do so. We request necessary (or argued for more germination. Because of the diversity of comment on whether, in a final rule, a disinfection method choices) for bean practices, processes, and procedures, food safety plan and/or an operational sprouts. Our 1999 Sprout Guides apply the controls reasonably necessary to assessment should be required for farms to all sprouted seeds and beans (Ref. 14. prevent the introduction of known or conducting covered activities related to Ref. 15) and we are proposing in subpart reasonably foreseeable hazards into or sprouts, either in addition to or in place M to cover all sprouts, including bean onto seeds or beans that you use for of the standards proposed in this sprouts. Our earliest efforts to promote sprouting may vary. Therefore, we are subpart. We also request comment on sprout safety, including consumer not proposing to prescribe specific whether a written plan similar to the advisories, focused primarily on green measures that are reasonably necessary type required under section 418 of the sprouts, such as alfalfa and clover to prevent the introduction of known or FD&C Act would be more appropriate sprouts, where we were seeing sprout reasonably foreseeable hazards into or for farms conducting covered activities outbreaks and because we assumed bean onto seeds or beans. However, you may related to sprouts. sprouts were most often cooked before refer to our recommendations in consumption (Ref. 238). However, in relevant guidances (Ref. 14. Ref. 10). 1. Comments Relevant to the Proposed 2002, we updated our consumer It is well-established that sprouts can Provisions advisories to include advice on the risks become contaminated through the use of We received very few comments associated with eating all types of contaminated seeds for sprouting. related specifically to sprouts. Those sprouts, including raw and lightly Therefore, we considered proposing a that were submitted were generally cooked bean sprouts based on four supplier approval and verification supportive of our efforts to create foodborne illness outbreaks associated program for seeds and beans received by policies to prevent illness and produce with mung bean sprouts between 2000 sprouters for sprouting purposes. Such

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a program would provide assurance that Canadian and Irish authorities include multiple sprout farms before it is known seeds or beans received from a third recommendations that seeds and beans or suspected to be contaminated. As party for use to grow sprouts are grown, be tested by the distributor, and that the discussed in the QAR, we are aware of harvested, stored, and handled using sprouter obtain a Certificate of Analysis outbreaks associated with multiple measures reasonably necessary to (CoA) for the seeds and beans (Ref. 240. sprout farms using the same lot of seed. prevent the introduction of known or Ref. 245), but recognize the limitations In addition, pathogens, such as reasonably foreseeable hazards into or of testing seeds. Salmonella and E. coli O157:H7, can onto seeds or beans used for sprouting. While a negative test result is not a survive for an extended period of time However, a supplier approval and guarantee of the absence of pathogens, on seeds and beans, as evidenced by verification program may not be a positive test result would facilitate outbreaks linked to seed that is a year practical or effective for seeds and beans detection of contaminated seeds and or two old, so setting aside a potentially received by sprouters for sprouting beans for destroying or diverting to non- contaminated seed lot for later use does purposes. For example, for most crops, food use. Thus, we would encourage not reduce the likelihood of producing only a small percentage of the harvested seed suppliers and sprouters to test seed contaminated sprouts from that lot of seeds or beans goes to sprout production using statistically valid sampling and seeds or beans (Ref. 16. Ref. 243). For (Ref. 16. Ref. 241). Several distributors testing protocols. However, we these reasons, we have tentatively sell seeds and beans primarily for tentatively conclude that testing seeds concluded that, once you know or have agricultural use with little or no sales and beans is not sufficiently reliable to reason to believe that a lot of seeds or for sprouting (Ref. 16). Seeds and beans include as a measure necessary to beans is contaminated, through have a relatively long shelf-life, prevent the introduction of known or microbial testing or implication as the sometimes being stored for a year or reasonably foreseeable hazards. Instead, vehicle in an outbreak, there is reason longer, and they often pass through a we propose to focus on seed treatment to believe that other parts of that lot may number of business entities before their (proposed § 112.142) and testing spent also be contaminated, you must not use final sale. Therefore, the ultimate end irrigation water from each production that lot of seeds or beans to produce use of seeds and beans will likely not be batch of sprouts (or testing each sprouts. This is consistent with existing known by many growers, handlers, or production batch of sprouts at the in- guidances and standards (Ref. 16. Ref. distributors (Ref. 16. Ref. 196. Ref. 192. process stage when testing spent 18. Ref. 192. Ref. 193). Ref. 197). We are also not aware of any irrigation water is not practicable) Proposed § 112.141(c) would require regulatory standards that include a (proposed § 112.143). that you visually examine seeds and supplier approval and verification When seeds or beans are used to beans, and packaging used to ship seeds program for seeds and beans received by produce sprouts, they are ‘‘food,’’ as or beans, for signs of potential sprouters for sprouting purposes. For defined in section 201(f) of the FD&C contamination with known or example, Food Standards Australia New Act (Ref. 95). The definition of ‘‘food’’ reasonably foreseeable hazards. Visual Zealand (FSANZ) considered but did in proposed § 112.3 is consistent with examination of seeds and beans for not require such a program (Ref. 242). this interpretation. When you grow, sprouting, and the packaging used to We ask for comment on this approach harvest, pack, and store seeds and beans ship them, provides an opportunity to and whether there are additional for sprouting at your operation, you see signs of potential contamination, practical steps or practices that can be know the end use of the seeds and such as rodent or bird feces or urine, taken to ensure the safety of seeds and beans, and proposed § 112.141(a) would which may introduce pathogens into or beans used for sprout production. require that you exercise control over onto sprouts (Ref. 241. Ref. 246). Feces Specifically, we request comments on that input into your sprout production. from rodents and birds are known to whether a supplier approval and On the other hand, growers of seeds and carry pathogens (Ref. 247). This verification program for seeds and beans beans may be unaware as to whether proposed provision is consistent with intended for sprout production is their crop will be used for sprout recent FDA and international guidance practical and effective. production. We seek comment on any (Ref. 38. Ref. 18. Ref. 192. Ref. 193). We also considered whether to provisions that would be effective in Proposed § 112.142 would establish propose a requirement that you test reducing the risk posed by measures you must take for growing, incoming seeds and beans, and rejected contaminated seeds or beans in such harvesting, packing, and holding this approach. Although cases, without also imposing an undue sprouts. Specifically, proposed epidemiological investigations often burden on the agricultural sector that § 112.142(a) would require that you identify seeds and beans as the most produces seed used primarily for grow, harvest, pack, and hold sprouts in likely source of contamination, purposes of growing food or feed crops a fully-enclosed building. Proposed contamination may be at very low levels and not intended for use as food for § 112.142(b) would require that any (4 CFU/kg seed) (Ref. 16) and laboratory human consumption as sprouts. food-contact surfaces you use to grow, analyses have frequently been unable to Proposed § 112.141(b) through (c) harvest, pack, or hold sprouts must be isolate pathogens from implicated seeds would establish additional requirements sanitized after cleaning and before or beans (Ref. 243). In a recent EFSA to ensure that seeds and beans do not contact with sprouts or seeds or beans publication, the authors concluded that serve as a vehicle for introducing used to grow sprouts. As discussed in a 2-class sampling plan ‘‘absence in contamination in sprouts. Proposed the QAR, although the source of 25g’’, n=5; c=0, as specified in EC § 112.141(b) would require that if you contamination in outbreaks associated Regulation 2073/2005 for sprouted know or have reason to believe that a lot with sprouts has most often been seeds, will not give sufficient of seeds or beans has been associated incoming seeds or beans, pathogens can confidence to demonstrate the absence with foodborne illness, you must not also be introduced during sprout of a target pathogen at these low levels use that lot of seeds or beans to produce growing, harvesting, packing, and in seeds. To increase the probability of sprouts. Contamination of seeds and holding. rejection of a positive lot, the authors beans is generally at a low level and not Therefore, we are proposing these estimated that it would be necessary to distributed homogeneously throughout additional requirements for sprout farms analyze kilogram quantities of the a seed lot. Thus, a seed lot may be in (i.e., conducting operations in a fully sample (Ref. 244). Guidances from distribution for some time and in use by enclosed building, sanitizing food-

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contact surfaces after cleaning) because on seed. Scientific literature indicates are positive), as would normally be we have tentatively concluded that the that the 20,000 ppm Ca(OCl)2 treatment, expected, the percentage of sprouting process represents a unique widely adopted by sprouters who treat contaminated batches was reduced from bacterial amplification step that requires seed prior to sprouting, produces a 2.5 13.7 to 0.1%. Where the initial a higher level of care compared to the log reduction, with a range of 1.0–6.5 contamination was high and uniform, growing, harvesting, packing, and log reduction (Ref. 192. Ref. 201). Other the proportion of contaminated batches holding of other covered produce. This chemical and physical seed disinfection was reduced only from 100 to 87.7% proposed approach, a higher level of treatments, alone and in combination, (Ref. 251). care compared to produce growing, have been evaluated for efficacy but For these reasons we continue to harvesting, packing and holding there is a high degree of variability in believe that seed disinfection treatments generally, is consistent with Codex research results based on a number of are valuable as one of several measures guidelines (Ref. 50). factors (e.g., seed type, whether seed necessary to ensure the safety of Proposed § 112.142(c) would require was naturally or artificially sprouts. We ask for comment on this you to treat seeds or beans that will be contaminated, level of initial approach. used to grow sprouts using a contamination). In their evaluation of Proposed § 112.143 would establish scientifically valid method immediately the current state of microbiological requirements for testing procedures you before sprouting to reduce safety of seeds and sprouts, Fett et al. apply to the growing, harvesting, microorganisms of public health (Ref. 243) present a comparison of the packing, and holding of sprouts. significance. Consistent with our efficacy of select aqueous chemical Specifically, proposed § 112.143(a) would require that you test the growing, previous discussion of the term disinfection treatments with Ca(OCl)2 ‘‘scientifically valid’’ with respect to for sanitizing alfalfa seed from the harvesting, packing, and holding testing in the proposed rule to establish literature. Canada recommends a lower environment for Listeria spp. or L. Current Good Manufacturing Practice level of calcium hypochlorite, 2,000 monocytogenes (Lm) in accordance with requirements for dietary ingredients and ppm (Ref. 245). the requirements of § 112.144. The dietary supplements (68 FR 12157 at proposed testing requirement in We acknowledge that several 12198), we use the term ‘‘scientifically § 112.143(a) is in response to emerging outbreaks have brought into question valid’’ to mean using an approach that concerns about positive sample findings the effectiveness of seed disinfection is based on scientific information, data, and multiple recalls associated with L. treatments. For example, an outbreak of or results published in, for example, monocytogenes in sprouts (Ref. 17. Ref. scientific journals, references, text Salmonella kottbus in alfalfa sprouts 252). Between 2002 and 2010, there books, or proprietary research. Methods was linked to seed that underwent a have been 10 recalls involving multiple used for reducing microorganisms of chlorine sanitization step, although sprout types due to potential or public health significance in seeds or records indicate the concentration of confirmed contamination with L. beans for sprouting must be chlorine was probably lower than the monocytogenes (Ref. 253). In one of scientifically valid if they are to provide recommended 20,000 ppm (Ref. 248). these recalls, the strain found in sprouts assurance that they are effective. Conversely, in 1999, an outbreak of matched the strain isolated from 20 Prior treatment conducted by a Salmonella enterica serotype Mbandaka confirmed cases of listeriosis in 6 States grower, handler, or distributor of seeds occurred in Oregon, Washington, Idaho, and positive sample findings from an or beans, does not eliminate your and California. Based on epidemiologic environmental investigation at the responsibility to treat seeds or beans and pulsed-field gel electrophoresis sprouting operation (Ref. 252). immediately before sprouting, at your evidence from 87 confirmed cases, the Contamination from L. covered farm. This proposed outbreak was linked to contaminated monocytogenes from the environment is requirement is consistent with alfalfa seeds grown in California’s common (Ref. 207) and, thus, targeted NACMCF recommendations and our Imperial Valley. Trace-back and trace- preventive controls to minimize L. Sprout Guide (Ref. 16. Ref. 14) and forward investigations identified a monocytogenes in RTE foods are international guidance (Ref. 193. Ref. single lot of seeds used by five sprout warranted. While appropriate sanitation 191. Ref. 38). Specifically, NACMCF growers during the outbreak period. measures can minimize the presence of recommends that seed treatments that Cases of salmonellosis were linked with environmental pathogens in a sprouting deliver less than a 5-log pathogen two sprout growers who had not operation, we tentatively conclude that reduction be coupled with a microbial employed chemical disinfection; no environmental monitoring is still testing program. We did not cite any cases were linked to the three sprout necessary for sprouting operations as an specific log reduction in our Sprout growers who used seed disinfection added safety measure. Such monitoring Guide as ‘‘adequate to reduce (Ref. 249). In another outbreak of can be conducted by testing for the pathogens.’’ At that time, few if any Salmonella typhimurium in clover specific pathogenic microorganism or by seed treatments were thought to be sprouts linked to seed sold to multiple testing for an ‘‘indicator organism,’’ capable of consistently delivering a 5- sprout operations, sprouters who had which can indicate conditions in which log pathogen reduction. treated the seeds in 20,000 ppm the environmental pathogen may be A number of treatments have been chlorine had fewer cases attributed to present. Typically, a firm that finds an shown to reduce levels of, but not their sprouts compared to those that did indicator organism during eliminate, pathogenic bacteria present not (Ref. 250). This is consistent with environmental monitoring conducts on seeds. Such treatments are likely to modeling work by Montville and microbial testing of surrounding reduce the level of contamination if Schaffner, indicating that, while surfaces and areas to determine the present and, in turn, decrease the risk disinfection of seeds prior to sprouting potential source of the contamination, for foodborne disease with sprouted did not guarantee pathogen free sprouts, cleans and sanitizes the contaminated seeds (Ref. 16). We cited in the Sprout disinfection reduced the percentage of surfaces and areas, and conducts Guide a 20,000 ppm calcium contaminated batches. Seed disinfection additional microbial testing to hypochlorite treatment as an example of was most effective when contamination determine whether the contamination a treatment that has been shown to be was sporadic and at low levels; at a low has been eliminated. Further steps may effective for the reduction of pathogens prevalence (1 out of 10,000 25-g samples be necessary if the indicator organism is

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found on retest. Tests for the indicator FD&C Act. The proposed testing irrigation water (Ref. 244). We organism Listeria spp. detect multiple requirement in § 112.143(b) to test spent tentatively concur with this conclusion. species of Listeria, including the sprout irrigation water (or sprouts) for In developing our Sprout Guides in pathogen L. monocytogenes. For Salmonella and E. coli O157:H7 would 1999 and in deliberations for this example, USDA’s FSIS regulations and codify current recommendations in our proposed rule, we also considered guidelines use Listeria spp. as an Sprout Guides and is consistent with whether to include testing spent sprout appropriate indicator organism for L. existing international guidelines and irrigation water for L. monocytogenes, in monocytogenes in for RTE meat or regulations (Ref. 38. Ref. 191. Ref. 193). addition to testing it for Salmonella spp. poultry products exposed to the We are proposing these testing and E. coli O157:H7. However, we processing environment after cooking to requirements in § 112.143(b) in addition tentatively concluded that testing spent prevent product adulteration by L. to the proposed treatment requirements sprout irrigation water for Listeria has a monocytogenes (Ref. 254). FDA’s in § 112.142(c) because pathogens that number of potential challenges. The current thinking is that Listeria spp. is are merely injured, but not killed, by warm, moist, nutrient-rich conditions an appropriate indicator organism for L. seed treatment could potentially grow during sprouting encourage the monocytogenes, because tests for out again when subjected to enrichment proliferation of Salmonella and E. coli Listeria spp. will detect multiple species conditions, as experienced during O157:H7 and this proliferation increases of Listeria, including L. monocytogenes, sprouting (Ref. 16. Ref. 74). Because the probability of their detection, if and because the available information seed disinfection treatments can reduce, present. In contrast, Listeria may be a supports a conclusion that modern but may not eliminate, pathogens on poor competitor at the warmer sanitation programs, which incorporate seed, we are proposing to require temperatures and against the high level environmental monitoring for Listeria microbiological testing. Spent irrigation of native microflora present during the spp., have public health benefits. The water that has flowed over and through sprouting process. In addition, Listeria taking of actions based on the presence sprouts is a good indicator of the types is ubiquitous. We would expect frequent of an appropriate indicator organism is and quantities of microorganisms in the positives using rapid tests for Listeria protective of public health, since there sprouts themselves (differing by only 1 spp., which would not necessarily mean will be times when steps are taken in log or less from the level in the sprouts) pathogens were present. Such testing the absence of the pathogen. Therefore, and the microflora in spent irrigation would need to be followed by we tentatively conclude that testing the water is fairly homogeneous (Ref. 15. confirmatory testing to determine growing, harvesting, packing and Ref. 198. Ref. 209). The optimal time for whether or not L. monocytogenes was testing is when pathogen levels are holding environment for Listeria spp. or present in order to determine highest (approximately 24–48 hours L. monocytogenes is a necessary appropriate actions with respect to the after the start of sprouting), but also measure to ensure the safety of sprouts. product. While rapid test kits are now when it is early enough in the sprouting available to screen for L. Proposed § 112.143(b) would require process to obtain results before product monocytogenes, their use on spent that you either: (1) Test spent sprout is shipped. irrigation water from each production We have emphasized testing irrigation sprout irrigation water or sprouts would batch of sprouts for E. coli O157:H7 and water in proposed § 112.143(b) because need to be validated (Ref. 14). We Salmonella spp. in accordance with the testing sprouts has several significant tentatively conclude that environmental requirements of § 112.146; or (2) if disadvantages compared to testing spent monitoring for Listeria spp. or L. testing spent sprout irrigation water is irrigation water. First, contamination of monocytogenes is the most practical not practicable (for example, for soil- sprouts is not likely to be as approach for control of this pathogen. grown sprouts), that you test each homogeneous as is the spent irrigation We request comments on this tentative production batch of sprouts at the in- water (Ref. 243. Ref. 255). Second, conclusion. process stage (i.e., while sprouts are still multiple sprout samples must be taken We also considered the growing) for E. coli O157:H7 and from different locations in the drum or appropriateness of proposing provisions Salmonella spp. in accordance with the trays to ensure that the sample collected for testing spent sprout irrigation water requirements of § 112.146. A production is representative of the batch. for non E. coli O157:H7 shiga toxin- batch for which either of these Furthermore, additional preparation producing E. coli (STEC) which were pathogens is detected in the spent (e.g., selecting representative involved in the recent large sprout irrigation water for the sprouts would be subsamples for analyses, blending or associated E. coli O104 foodborne considered adulterated under Section stomaching) is required when testing illness outbreak in Europe (Ref EU OB). 402(a)(4) of the FD&C Act, in that it has sprouts. Each additional step introduces The O104:H4 strain that caused the been prepared, packed, or held under a possibility for error. Consequently, outbreak in Europe was an unusual insanitary conditions whereby it may testing of spent sprout irrigation water strain that none of the tests that were have been rendered injurious to health. is generally preferred over testing being used to test for A production batch for which either of sprouts unless production methods enterohaemorrhagic E. coli (EHEC) at these pathogens is detected in the make it impractical to test spent sprout that time would have picked it up. The sprouts would be considered irrigation water. For example, spent challenge is that there are estimated to adulterated under Sections 402(a)(1) of irrigation water may not be available be 400 serotypes of E. coli that produces the FD&C Act, in that the sprouts when sprouts are grown in soil. any one of the 3 Stx1 and/or 8 Stx2 contain a poisonous or deleterious We chose pathogen testing for subtypes and many of these are isolated substance which may render it injurious Salmonella spp. and E. coli O157:H7 from environmental and animal sources to health. Therefore, we tentatively because these pathogens are the two but have not been implicated in human conclude that microbiological testing of most common agents in sprout- illness. Many of the STEC strains spent irrigation water from each associated outbreaks in the U.S. (Ref. 3). entailed tedious plating and retesting to production lot (or of each production Recently, EFSA concluded that there are isolate and even longer to serotype (Ref. batch of sprouts) is necessary to provide currently no indicator organisms that 256). For these reasons, we tentatively reasonable assurances that sprouts are can effectively substitute for the testing conclude that proposing to require not adulterated under Section 402 of the of pathogens in seeds, sprouted seeds or testing spent sprout irrigation water for

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non E. coli O157:H7 STECs would not testing is a minimum requirement more remote non-food-contact surfaces be a practical approach at this time. (proposed § 112.144(c)(2)). More that are in the area used for growing, We request comments on this frequent testing may be needed. For harvesting, packing, and holding and tentative conclusion, and on whether example, the frequency of monitoring could lead to contamination of zones 1 pathogens in addition to E. coli O157:H7 for environmental pathogens should and 2; and Zone 4 consists of non-food- and Salmonella spp. should be included increase as a result of finding the contact surfaces, outside of the area in testing of spent sprout irrigation environmental pathogen or an indicator used for growing, harvesting, packing, water or in-process sprouts, either by of the environmental pathogen or as a and holding from which environmental specifically listing the additional result of situations that pose an pathogens can be introduced into the pathogens or by set criteria (e.g., increased likelihood of contamination, growing, harvesting, packing, and association with one or more outbreaks e.g., construction (Ref. 211. Ref. 212). holding environment. Generally the linked to sprouts) for inclusion. The frequency of taking environmental number of samples and frequency of Proposed § 112.144 would establish samples will vary depending on existing testing is higher in zones 1 and 2 requirements for how you test the data on the presence of the because of the greater likelihood of food growing, harvesting, packing, and environmental pathogen of concern in contamination if the environmental holding environment for Listeria spp. or the environment where foods are pathogen is present in these zones. L. monocytogenes. Specifically, exposed to the environment. In the Information on appropriate locations for proposed § 112.144(a) would require absence of information, data should be sampling within these zones can be that you establish and implement a generated to assist in determining the found in the literature (Ref. 175. Ref. written environmental monitoring plan frequency of monitoring (Ref. 257). We 212). Operators should become familiar that is designed to find L. request comment on whether the with locations in which environmental monocytogenes if it is present in the minimum frequency of at least monthly pathogens have been found in other growing, harvesting, packing or holding for environmental monitoring is sprout firms and use this information in environment. Proposed § 112.144(b) adequate to assess whether the measures selecting sites to sample. would require that your written taken to minimize the risk associated L. monocytogenes frequently environmental monitoring plan be with L. monocytogenes in sprouts are establishes itself in a harborage site on directed to sampling and testing for effective. We tentatively conclude that equipment and grows (increases in Listeria spp. or L. monocytogenes. specifying the frequency of testing in number) there, where both food and Proposed § 112.144(c)(1) through (3) the written environmental monitoring moisture are available. L. would require that your written plan is necessary to enable assurance by monocytogenes organisms work their environmental monitoring plan include the operator and verification by FDA way out of the harborage site during a sampling plan that specifies: What you that testing efforts are consistent with a production and contaminate food. will test collected samples for (i.e., carefully thought through effort to find Testing food-contact surfaces for Listeria Listeria spp. or L. monocytogenes) the environmental pathogen if it is spp. is a commonly recommended (proposed § 112.144(c)(1)); How often present in the environment. verification measure for firms producing you will collect environmental samples, The purpose of environmental refrigerated RTE foods (Ref. 175. Ref. which must be no less than monthly monitoring is to verify the 211). (proposed § 112.144(c)(2)); and Sample implementation and effectiveness of Examples of appropriate non-food- collection sites. The number and sanitation measures for controlling the contact surfaces that could be monitored location of sampling sites must be presence of L. monocytogenes in the include exteriors of equipment, sufficient to determine whether sprout production environment. The equipment supports, control panels, measures are effective and must include monitoring must be designed to find door handles, floors, drains, appropriate food-contact surfaces and environmental pathogens that remain in refrigeration units, ducts, overhead non-food-contact surfaces of equipment, the sprouting operation after routine structures, cleaning tools, and motor and other surfaces within the growing, cleaning and sanitizing procedures in housings. Standing water in growing, harvesting, packing, and holding order to prevent contamination of harvesting, and packing areas and areas environment (proposed § 112.144(c)(3)). product that could lead to illness. To that have become wet and then have Proposed § 112.144(d) would require accomplish this purpose, there must be dried are also appropriate places to you to collect environmental samples a scientific basis for the locations monitor. Testing non-food-contact and test them for Listeria spp. or L. selected for sampling, the number of surfaces for L. monocytogenes or Listeria monocytogenes according to the method samples taken, the frequency of spp. is a commonly recommended in § 112.152. sampling, the sampling procedures used verification measure for firms producing Proposed § 112.144(c)(1) would and the test methodology. The sampling refrigerated or frozen RTE foods (Ref. require that you specify whether you must be biased—i.e., the locations to be 258. Ref. 259) and can detect L. will be testing for the pathogen L. tested must be those in which the monocytogenes that is brought into the monocytogenes or the indicator environmental pathogens can enter the plant by people or objects. Actions you organism, Listeria spp. As discussed environment where the food is exposed then take can prevent transferring the above, FDA’s current thinking is that and those areas where harborage of the organisms to a food-contact surface Listeria spp. may be an appropriate pathogen is likely (Ref. 258). (where they can contaminate food) or indicator organism for L. One approach to defining sampling from establishing a harborage that can monocytogenes, because tests for locations is to divide the sprouting serve as a source of contamination. Listeria spp. will detect multiple species operation into zones based on the Proposed § 112.145 would establish of Listeria, including L. monocytogenes. likelihood of contamination of the requirements for actions you must take FDA expects environmental monitoring product. A common industry practice is if you detect Listeria spp. or L. to be conducted with sufficient to use four zones (Ref. 213. Ref. 212): monocytogenes in the growing, frequency to detect the environmental Zone 1 consists of food-contact surfaces; harvesting, packing, or holding pathogen or appropriate indicator Zone 2 consists of non-food-contact environment, i.e., Conduct additional organism if present. We tentatively surfaces in close proximity to food and microbial testing of surfaces and areas conclude that monthly sampling and food-contact surfaces; Zone 3 consists of surrounding the area where Listeria spp.

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or L. monocytogenes was detected to testing (proposed § 112.145(c)) are particularly when the hazard is present evaluate the extent of the problem, necessary to determine the efficacy of at very low levels and is not uniformly including the potential for Listeria spp. cleaning and sanitizing. For example, distributed. If an environmental or L. monocytogenes to have become detection of the test organism after pathogen is detected on a food-contact established in a niche (proposed cleaning and sanitizing indicates that surface, finished product testing would § 112.145(a); Clean and sanitize the the initial cleaning was not effective, be appropriate only to confirm actual affected surfaces and surrounding areas and additional, more intensified contamination or assess the extent of (proposed § 112.145(b)); Conduct cleaning and sanitizing, or other actions contamination, because negative additional microbial sampling and may be needed, including dismantling findings from product testing could not testing to determine whether the Listeria equipment, scrubbing surfaces, and adequately assure that the spp. or L. monocytogenes has been heat-treating equipment parts (Ref. 207). environmental pathogen is not present eliminated (proposed § 112.145(c)); The finding of a test organism on a food- in food exposed to the food-contact Conduct finished product testing when contact surface usually represents surface. If you detect an environmental appropriate (proposed § 112.145(d)); transient contamination rather than a pathogen on a food-contact surface, the and Perform any other actions necessary harborage site (Ref. 259). However, sprouting operation should presume to prevent reoccurrence of the problem finding the test organism on multiple that the produce is adulterated under (proposed § 112.145(e)). Testing the surfaces in the same area, or continuing Section 402(a)(4) of the FD&C Act. environment of a sprouting operation to find the test organism after cleaning Finished product testing could be for L. monocytogenes (or for Listeria and sanitizing the surfaces where it was appropriate if an environmental spp. as an indicator of potential found, suggests a harborage site for the pathogen is detected on a non-food- contamination with L. monocytogenes), test organism. Mapping the location of contact surface, such as on the exterior and taking actions to eliminate L. contamination sites, whether the of equipment, on a floor or in a drain. monocytogenes or Listeria spp. when harborage site is on equipment or in the The potential for food to be found in the environment of a sprouting environment, can help locate the source contaminated directly from operation, is an important component of of the harborage site or identify contamination in or on a non-food- controlling microorganisms of public additional locations to sample (Ref. contact surface is generally low, but health significance (Ref. 175. Ref. 211). 257). transfer from non-food-contact surfaces The actions we are proposing to require, Proposed § 112.145 would not specify to food contact surfaces can occur. including additional testing to how certain actions must be performed, Finished product testing can provide determine the extent of contamination, such as the number of sites to test when useful information on the overall risk of ensuring contamination is eliminated the test organism is found in a sprouting a food when pathogens have been and taking steps to prevent its operation, or how to clean and sanitize detected in the environment. recurrence, are consistent with the surfaces on which the test organism Proposed § 112.145(e) would require recommendations in our Listeria Guide was detected. The number of sites that if environmental monitoring (Ref. 260). appropriate for testing and the identifies the presence of an If an environmental pathogen or an applicable cleaning and sanitizing environmental pathogen or appropriate appropriate indicator organism (the test procedures will depend on the indicator organism, the operator organism) is detected in the sprouting operation and the equipment. perform any other steps necessary to environment, steps must be taken to We tentatively conclude that, when prevent recurrence of the eliminate the organism, including microbial testing is conducted as part of contamination. Actions taken as a result finding a harborage site if one exists steps in light of the results of of monitoring for an environmental (Ref. 175. Ref. 211) (Ref. 257). environmental monitoring, specifying pathogen or an indicator organism for Otherwise, the presence of the such procedural requirements would such pathogen must ensure these environmental pathogen could result in not provide facilities with sufficient requirements are met. The measures for contamination of food-contact surfaces flexibility to develop and implement environmental monitoring specified in or food. The presence of the indicator aggressive and appropriate actions to proposed § 112.145(a) through (d) are organism suggests that conditions exist find and eliminate the source of the not all inclusive. Examples of measures in which the environmental pathogen contamination in the environment. Such that may be necessary include may be present and could result in actions may involve investigative reinforcing employee hygiene practices contamination of food-contact surfaces procedures when the initial measures and traffic patterns; repairing damaged or food. Actions must be taken for every have not been successful in eliminating floors; eliminating damp insulation, finding of an environmental pathogen or the environmental pathogen or indicator water leaks, and sources of standing indicator organism in the environment organism. One example of an water; replacing equipment parts that to prevent contamination of food- investigative procedure is taking can become harborage sites (e.g., hollow contact surfaces or food. samples from food-contact surfaces and/ conveyor rollers and equipment Sampling and microbial testing from or produce at multiple times during the framework), and repairing roof leaks surfaces surrounding the area where the day while the equipment is operating (Ref. 180. Ref. 219). Additional test organism was found (proposed and producing product (Ref. 207). information on measures for § 112.145(a)) are necessary to determine Proposed § 112.145(d) would require environmental monitoring can be found whether the test organism is more that if environmental monitoring in the literature (Ref. 180. Ref. 221. Ref. widely distributed than on the original identifies the presence of an 219). Proposed § 112.145 is consistent surface where it was found and to help environmental pathogen or indicator with the FSIS Listeria Guidelines (Ref. find the source of contamination if other organism, the operator conduct finished 254). sites are involved. Cleaning and product testing, when appropriate. As Proposed § 112.146 would establish sanitizing the contaminated surfaces discussed in section IV.I. of this requirements for how you collect and and surrounding areas (proposed document, there are shortcomings for test samples of spent sprout irrigation § 112.145(b)) are necessary to eliminate microbiological testing of food for water or sprouts. Specifically, proposed the test organism that was found there. process control purposes. Testing § 112.146(a) would require that you Additional sampling and microbial cannot ensure the absence of a hazard, establish and implement a written

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sampling plan that identifies the establish and keep regarding sprouts. and wastewater as published by the number and location of samples (of Under proposed § 112.150(a), you must American Public Health Association; or spent sprout irrigation water or sprouts) establish and keep the required records (3) methods prescribed in the FDA to be collected for each production in accordance with the requirements of Bacteriological Analytical Manual, or by batch of sprouts to ensure that the proposed subpart O. As discussed in another method that is at least collected samples are representative of section V.O. of this document, proposed equivalent to the above-mentioned three the production batch when testing for subpart O would establish general methods in accuracy, precision and contamination. Additionally, proposed requirements applicable to all records. sensitivity in detecting E. coli. § 112.146(b) would require that, in Proposed § 112.150(b) would require Proposed § 112.151(a)(1) provides for accordance with the written sampling you to establish and keep the following the use of official methods of analysis plan required under paragraph (a) of records: Documentation of your published by AOAC International in the this section, you aseptically collect treatment of seeds or beans to reduce latest edition of their publication samples of spent sprout irrigation water microorganisms of public health ‘‘Official Methods of Analysis of the or sprouts, and test the collected significance in the seeds or beans, at Association of Official Analytical samples for E. coli O157:H7 and your farm (proposed § 112.150(b)(1)); Chemists,’’ 18th edition, revision 4 Salmonella spp. using a method that has your written environmental monitoring (published in 2011). The Official been validated for its intended use plan in accordance with the Methods of Analysis of AOAC (testing spent sprout irrigation water or requirements of § 112.144 (proposed International (18th Ed., revision 4, 2011) sprouts) to ensure that the testing is § 112.150(b)(2)); your written sampling would be incorporated by reference accurate, precise, and sensitive in and testing plan for each production with the approval of the Director of the detecting these pathogens. This batch of sprouts in accordance with the Federal Register in accordance with 5 proposed provision is consistent with requirements of § 112.146(a) (proposed U.S.C. 552(a) and 1 CFR Part 5. recommendations in our Sprout Testing § 112.150(b)(3)); the results of any Proposed § 112.151(a)(2) would Guide, the Canada and Irish Codes and testing conducted in accordance with establish that methods of analysis the FSANZ standard (Ref. 15. Ref. 206. the requirements of §§ 112.143 and published in the Standard Methods for Ref. 201. Ref. 203). 112.144 (proposed § 112.150(b)(4)); any the Examination of Water and One means to test for E. coli O157:H7 analytical methods you use in lieu of Wastewater (21st Edition, 2005), and Salmonella spp. as required under the methods that are incorporated by American Public Health Association proposed § 112.146(b) is to follow our reference in § 112.152 (proposed would be acceptable for testing the guidance on sampling and testing spent § 112.150(b)(5)); and the testing method quality of water. In addition, the irrigation water or sprouts (Ref. 15). The you use in accordance with the Standards Methods for the Examination methods described in our guidance have requirements of § 112.146(b) (proposed of Water and Wastewater, (21st Ed., been validated to be effective on spent § 112.150(b)(6)). We are proposing to 2005), would be incorporated by sprout irrigation water and sprouts (Ref. require you to keep the above records reference in accordance with 5 U.S.C. 15. Ref. 223. Ref. 224). The effectiveness specific to sprout operations in order to 552(a) and 1 CFR part 5. of detection methods can vary help document your compliance with Proposed § 112.151(a)(3) would depending on multiple factors, the provisions of this rule. We establish that methods of analysis including but not limited to whether the tentatively conclude that such records published in Chapter 4 of the FDA sample tested is representative of the are needed for us to verify and you to Bacteriological Analytical Manual food, type of food, level of microflora ensure that appropriate measures are (Edition 8, Revision A, 1998) (BAM), as present, the enrichment procedure and being followed consistently and updated in June 2011, would be type of test used. Spent sprout irrigation correctly (e.g., your sampling plan for acceptable for testing the quality of water and sprouts have a high level of spent sprout irrigation water from each water. In addition, Chapter 4 of the natural microflora that can interfere production lot). The records would also BAM (Edition 8, Revision A, 1998), as with detection (Ref. 15. Ref. 243). allow FDA or you to identify trends that updated in June 2011, would be Therefore, other methods that have been might signal a need to adjust the incorporated by reference in accordance validated to be effective for other foods measures in your environmental with 5 U.S.C. 552(a) and 1 CFR part 5. may not work for spent sprout irrigation monitoring plan to improve its With advances in science and as water and sprouts. Because the effectiveness and reliability (e.g., test appropriate, FDA periodically updates microflora in spent sprout irrigation results from your environmental the BAM to add newer methods or water is more homogeneous compared monitoring program may signal the need revise existing ones. For the purposes of to seeds or sprouts, sampling to enhance sprouting operation cleaning this proposed rule, we refer to Chapter procedures described in our guidance and sanitation). 4 of the BAM (edition 8, revision A, for sprout irrigation water are relatively published in 1988) as updated in June simple. In addition, spent sprout N. Subpart N—Analytical Methods 2011. However, should FDA update or irrigation water can be used directly in Proposed subpart N would specify revise the methods and procedures the test procedures described in our methods of analysis for testing the currently listed in Chapter 4 of the June guidance, thus reducing the possibility quality of water and the growing 2011 version, for the purpose of testing of error (Ref. 15. Ref. 243). Sampling environment for sprouts, as required the quality of water, we encourage spent sprout irrigation water or sprouts under proposed subparts E and M (see industry to use such relevant, updated is an important testing procedure to sections V.E. and V.M., respectively, of methods and procedures. ensure contaminated product does not this document). Proposed § 112.151(a)(4) would enter commerce. The testing procedures Proposed § 112.151 would establish provide for the use of a method that is described in our guidance give accurate that you must test the quality of water at least equivalent in accuracy, results as quickly and simply as to satisfy the requirements of § 112.45 precision, and sensitivity to the possible on the presence or absence of by one of three methods: (1) Official methods in § 112.151(a)(1), (a)(2) or E. coli O157:H7 and Salmonella spp. methods of analysis published by the (a)(3). Test kit methods are generally not Proposed § 112.150 would establish AOAC International; (2) standards published in the literature due to their requirements for records that you must methods for the examination of water proprietary nature. FDA is aware of

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programs, such as the AOAC Research currently listed in Chapter 10 of the other purposes, so as to avoid Institute’s Performance Tested Methods April 2011 version, for the purpose of duplication, while another farmer Program that provides an independent testing the growing environment for commented that records or documents third-party review of proprietary test Listeria spp. or L. monocytogenes, we would not ensure safety and, therefore, method performance. Test methods encourage industry to use such relevant, asked that records should be required demonstrated to meet acceptable updated methods and procedures. for only annual activities, such as performance criteria are granted Proposed § 112.152 would also employee training and surveys of Performance Test Methods (PTM) status. provide for the use of a method at least surrounding land activities. Finally, The PTM certification assures users that equivalent in accuracy, precision, and several comments indicated that the an independent assessment has found sensitivity in detecting Listeria spp. or current legal liability system in the that the test method performance meets L. monocytogenes as is the method United States serves to discourage any an appropriate standard for the claimed described in Chapter 10 of the BAM. For grower or packing house from keeping use. FDA would consider methods, example, prescribed rapid detection kits additional detailed records related to particularly test kit methods, approved with their respective enrichment media food safety and that such records are by the PTM program or other similar may be conditionally used to screen for subject to intrusive judicial subpoena programs acceptable for testing the presence of Listeria contaminants. power. quality of water. FDA is also aware that Isolates may be rapidly positively or We believe that documentation of there are numerous scientific testing negatively confirmed as L. some practices is critical to ensure that and diagnostic development companies monocytogenes by using specific test science-based minimum produce safety kits. FDA is aware that there are that have invented rapid tests and standards proposed in this rule are numerous scientific testing and systems for pathogens and water adequately implemented on the farm. diagnostic development companies that quality. Many of these products undergo Records are useful for keeping track of have invented rapid tests and systems rigorous internal quality control and detailed information over a period of for Listeria spp. or L. monocytogenes. performance testing, as well as receive time. Records can identify patterns of Many of these products undergo additional third-party and/or regulatory problems and, thus, enable a farm to rigorous internal quality control and approvals. FDA is also aware that the find and correct the source of problems. performance testing, as well as receive Environmental Protection Agency (EPA) Records are also useful for investigators additional third-party and/or regulatory approves analytical methods that during inspections to determine industrial and municipal facilities use approvals. As discussed above in proposed § 112.151(a)(4), FDA would compliance with requirements (e.g., by to determine pollutants of wastewater FDA investigators to determine (published in 40 CFR Part 136) and to consider methods, particularly test kit methods, approved for example by the compliance with requirements that meet federal requirements or to would be established by this rule, or by demonstrate compliance with drinking AOAC Research Institute’s Performance Tested Methods Program PTM program a third party auditor that a farm or water and ground water regulations (40 retailer may voluntarily engage under a CFR 141.402 and 40 CFR 141.403). For or other similar, acceptable for testing Listeria spp. or L. monocytogenes. business arrangement between the farm example, the EPA, has approved the use and the retailer). Therefore, we ® ® of E*Colite Test, m-ColiBlue 24 Test, O. Subpart O—Requirements Applying tentatively conclude that records of only ® and Colitag Test for compliance to Records That You Must Establish and annual activities are insufficient to monitoring related to EPA’s Ground Keep ensure produce safety. However, in Water Rule. FDA would consider these As proposed, subpart O discusses the determining those circumstances in tests acceptable for testing the quality of general requirements applicable to which records are necessary as part of water to satisfy the requirements of documentation and records that you science-based minimum standards that § 112.45. must establish and maintain under minimize the risk of serious adverse Proposed § 112.152 establishes the proposed part 112. health consequences or death and methods you must use to test the provide reasonable assurances that growing environment for Listeria spp. or 1. Comments Relevant to the Proposed produce is not adulterated under section L. monocytogenes to satisfy the Requirements 402 of the FD&C Act, we considered the requirements of §§ 112.143(a) and We received several comments in statutory direction in section 112.144. As proposed, you must test response to the 2010 FR notice that 419(c)(1)(C) of the FD&C Act to comply environmental samples using the addressed issues relevant to establishing with the Paperwork Reduction Act (44 methods and procedures described in and maintaining documents and U.S.C. 3501 et seq.) ‘‘with special Chapter 10 of the BAM, ‘‘Listeria records. Comments expressed concern attention to minimizing’’ the monocytogenes, Detection and over the costs of complying with record recordkeeping burden on the business Enumeration of Listeria monocytogenes keeping requirements. Several and collection of information as defined in Foods.’’ Chapter 10 of the BAM comments also stated that there should in that act. We propose to require (Edition 8, Revision A, 1998), as not be a requirement for electronic records in instances where maintenance updated in April 2011, would be record keeping for farmers, especially if of detailed information is needed to incorporated by reference in accordance they are small-scale. One comment keep track of measures directed at with 5 U.S.C. 552(a) and 1 CFR part 5. requested that, to protect the minimizing the risk of known or With advances in science and as confidentiality of individual farm reasonably foreseeable hazards, where appropriate, FDA periodically updates businesses, any recordkeeping identification of a pattern of problems is the BAM to add newer methods or requirements be accompanied by important to minimizing the risk of such revise existing ones. For the purposes of assurance that information accessed by hazards, or where they are important to this proposed rule, we refer to Chapter federal government authorities with facilitate verification and compliance 10 of the BAM (Edition 8, revision A, respect to food safety protocols will with standards and this cannot be published in 1998) as updated in April remain confidential. Another comment effectively done by means other than a 2011. However, should FDA update or requested that we consider pre-existing review of records. See section IV.E of revise the methods and procedures records kept by the produce industry for this document for further discussion.

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We appreciate the concerns expressed thus far, we are not aware that any of origin) are vague and subject to varying by some commenters with respect to these industries has been adversely interpretations and, thus, will not cost and burden to farms. To the extent affected by excessive judicial subpoenas ensure that required measures have possible, we attempted to propose resulting from their recordkeeping. been taken or standards have been met. documentation requirements that are In addition, it is not possible to discern 2. Proposed Requirements risk-based and capable of being tailored a trend without actual measurement to your individual farm, taking into Proposed subpart O would establish values. account the unique characteristics of the requirements that would be applicable Proposed § 112.161(a)(1) is consistent operation, the commodities handled, to all records required by part 112. FDA with our HACCP regulations for seafood and the operation’s growing, harvesting, tentatively concludes that the and juice. Our HACCP regulations for packing, and holding procedures. A requirements in subpart O describing seafood and juice require that all large majority of growers, farmers, and how records must be established and records include the name and location producers indicated during listening maintained, including the general of the processor; the date and time of sessions and other stakeholder requirements, record retention the activity that the record reflects; the discussions that they already practice requirements, and requirements for signature or initials of the person good agricultural practices and keep official review and public disclosure, performing the operation; and where adequate records. They agreed that such are applicable to all records that would appropriate, the identity of the product recordkeeping is necessary. Moreover, be required under all subparts, because and the production code, if any they indicated that the cost of a large records that would be required under (§§ 123.9(a) and 120.12(b), respectively). scale recall event would have the each of the subparts would aid farms in Our HACCP regulations for seafood and potential to far exceed the cost of complying with the requirements of part juice also require that records contain routine record keeping. 112; and allow farms to show, and FDA the actual values (such as temperature) As proposed, the recordkeeping to determine, compliance with the and observations obtained during requirements allow the use of existing requirements of part 112. monitoring (§§ 123.6(c)(7) and records and do not require duplication, a. General Requirements 120.12(b)(4), respectively). provided such records satisfy all of the Additional requirements in proposed applicable requirements of this part (see As proposed, § 112.161(a)(1) requires § 112.161(a) include that records must proposed § 112.163). In addition, per that your records include: (i) The name be created at the time an activity is proposed § 112.165, electronic records and location of your farm; (ii) actual performed or observed (proposed would be acceptable but would not be values and observations obtained during § 112.161(a)(2)); be accurate, legible, and required by this subpart. Records would monitoring; (iii) an adequate description indelible (proposed § 112.161(a)(3)); and be acceptable under this subpart if kept (such as the commodity name, or the be dated, and signed or initialed by the in forms as diverse as hard copies of specific variety or brand name of a person who performed the activity handwritten logs, invoices, and commodity, and, when available, any documented (proposed § 112.161(a)(4)). documents reporting laboratory results, lot number or other identifier) of These requirements would ensure that provided that they are indelible and covered produce applicable to the the records are useful to the owner, legible. record; (iv) the location of a growing operator, or agent in charge of a farm in We understand the concerns area (for example, a specific field) or complying with the requirements of part regarding confidentiality. Our other area (for example, a specific 112, for example, in documenting disclosure of information is subject to packing shed) applicable to the record; compliance with monitoring the Freedom of Information Act (FOIA) and (v) the date and time of the activity requirements. These proposed (5 U.S.C. 552), the Trade Secrets Act (18 documented. requirements would also ensure that the U.S.C. 1905), the FD&C Act, and our The name and location of your farm records would be useful to FDA in implementing regulations under part 20, and the date and time would allow the determining compliance with the which include protection for owner, operator, or agent in charge of a requirements of part 112. For example, confidential commercial information farm (and, during inspection, an FDA the signature of the individual who and trade secrets. We note that many investigator) to assess whether the made the observation would ensure segments of the food industry already record is current and establish the responsibility and accountability. In are subject to food safety-related relevance of the record to your farm, addition, if there is a question about the recordkeeping requirements similar to which is necessary for review by record, a signature would ensure that those proposed in this subpart. Other regulators. An adequate description of the source of the record will be known. existing food safety regulations, such as covered produce would allow the farm These proposed requirements are the infant formula quality control to more readily track measures, identify consistent with our HACCP regulations procedures regulation (§ 106.100), the a pattern of problems, and verify for seafood and juice. Our HACCP dietary supplement regulation compliance. Such a description will regulations for seafood and juice require (§ 111.605 and § 111.610), the acidified also allow the farm to identify specific that processing and other information be foods regulation (§ 114.100), the produce for which the standards of this entered on records at the time that it is regulation on production, storage, and part have not been met, and to take observed (§§ 123.9(a)(4) and transportation of shell eggs (§ 118.10), appropriate measures as provided for 120.12(b)(4), respectively). the juice HACCP regulation (§ 120.12), under § 112.11. As proposed, under § 112.161(b), and the seafood HACCP regulation Recording actual values and when records are required to be (§ 123.9) require similar record keeping. observations during monitoring are established and kept in subparts C, E, F, In addition, many farmers that are part necessary to produce an accurate record. L, and M of this part (§§ 112.30, 112.50, of the various programs such as Notations that monitoring 112.60, 112.140, and 112.150), you must National Organic Program and LGMA measurements are ‘‘satisfactory’’ or establish and keep documentation of already have similar recordkeeping ‘‘unsatisfactory,’’ without recording the actions you take when a standard in requirements (Ref. 45. Ref. 261). actual times and observations (e.g., those subparts is not met. This Recordkeeping has proven useful for the temperatures and turnings in treating documentation is necessary to show that above-mentioned food industries and, biological soil amendments of animal you have taken the steps reasonably

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necessary to minimize the risk of from either the Internet or electronic or affect your operation over time. Multi- serious adverse health consequences or digital storage applications. year retention of records allows an death from the use of, or exposure to, Proposed § 112.162 is consistent with owner, operator, or agency to better covered produce, including those our HACCP regulations for seafood and understand and proactively respond to measures reasonably necessary to juice. Our HACCP regulation for seafood the risk factors affecting his or her farm. prevent the introduction of known or provides for transfer of records if record Since many weather events, such as reasonably foreseeable hazards into storage capacity is limited on a drought or floods, which have an covered produce, and to provide processing vessel or at a remote influence on the safety of fresh produce reasonable assurances that the produce processing site, if the records could be are relatively rare; maintaining is not adulterated under section 402 of immediately returned for official review historical records to inform the the FD&C Act. For example, if under upon request (§ 123.9(b)(3)). Our development of preventive controls § 112.44(b) you are required to HACCP regulation for juice permits specific to a given operation is discontinue the use of agricultural water offsite storage of processing records after invaluable. Similarly, proposed and take corrective steps, this provision 6 months following the date that the § 112.164(b) would establish that would require you to establish and keep monitoring occurred, if such records can records that relate to the general a record of the corrective steps that you be retrieved and provided onsite within adequacy of the equipment or processes took. 24 hours of request for official review being used by a farm, including the As proposed, § 112.161(c) would and considers electronic records to be results of scientific studies and require a supervisor or responsible party onsite if they are accessible from an evaluations, must be retained at the to review, date, and sign those records onsite location (§ 120.12(d)(2)). We seek farm for at least two years after the use that are required under 112.50(b)(4), comment on the appropriateness of the of such equipment or processes is 112.50(b)(5), 112.60(b)(1), 112.60(b)(3), proposed recordkeeping requirements. discontinued. 112.140, 112.150(b)(1), 112.150(b)(4), Certain growers and packers of c. Use of Existing Records and 112.161(b). These records relate to covered produce currently retain certain of your testing, monitoring, As proposed, § 112.163 would clarify records for at least two years. For sanitizing, and corrective action that the regulations in this part do not example, produce operations certified activities. As described above, one of require duplication of existing records if by the National Organic Program must the primary purposes for establishing those records contain all of the maintain their records relating to the and maintaining records is so that you information required by this part. In this production, harvesting, and handling of can review the records to see if the provision, we seek to minimize the ‘‘organic’’ agricultural products for at requirements of this part have been met. burden of keeping records to that which least five years beyond the creation of Requiring a signature from a supervisor is necessary to accomplish the intended the records (7 CFR 205.103). USDA’s or responsible party for these records purposes of this part. Agricultural Marketing Service requires emphasizes the importance of such a For example, as proposed, you are not that restricted use pesticide records be review. required to duplicate existing records, maintained for two years from the date such as records kept to satisfy the of pesticide application (7 CFR 110.3). b. Storage of Records requirements of the National Organic Under USDA’s regulations Proposed § 112.162 would establish Program, if those records contain all of implementing the Perishable the requirements regarding where your the information required by this part. Agricultural Commodities Act, 1930 records must be stored. Proposed Additionally, you are not required to (PACA), packers who pack and sell § 112.162(a) establishes that offsite keep all of the information required by another firm’s produce and growers and storage of records is permitted after 6 this part in one set of records. Similarly, packers who voluntarily obtain a PACA months following the date the record if you have records containing some but license are required to preserve records was made if such record can be not all of the required information, this for two years (7 CFR 46.14). Under the retrieved and provided onsite within 24 proposed regulation provides you the Florida Tomato Rule (‘‘Tomato Good hours of request for official review. FDA flexibility to keep any additional Agricultural Practices [T–GAP] & realizes that the proposed requirements information required by this part either Tomato Best Management Practices’’) for recordkeeping could require some separately or combined with your (Ref. 262), firms must keep records farms to store a significant quantity of existing records. While we propose this documenting adherence to T–GAPs, records, and that there may not be provision to give you the greatest degree ‘‘including those addressing adequate storage space in the farm for of flexibility, we remind you that environmental review, water usage, these records. Providing for offsite keeping records together in one place record of completed education and storage of most records after 6 months likely will expedite review of records in training, pest control and crop would enable a farm to comply with the the event of a public health emergency production practices for the operation,’’ proposed requirements for record or during an FDA inspection or for at least three calendar years (Ref. 44). retention while reducing the amount of investigation. Participants in the California Leafy space needed for onsite storage of the Green Marketing Agreement (LGMA) d. Length of Time for Records Storage records without interfering with the must maintain their records kept under purpose of record retention, because the Proposed § 112.164(a) would require the LGMA agreement for two years (Ref. records will be readily available. that you keep records required by this 45). Proposed § 112.162(b) would clarify that part for two years after the date the electronic records are considered to be record was created. Retaining records e. Acceptable Formats for Records onsite at your farm if they are accessible for at least this length of time is As proposed, § 112.165 would require from an onsite location at your farm. For necessary to ensure that the records are that you keep records as either: (a) example, we would consider electronic available for reference during Original records; (b) true copies (such as records to be onsite if they were verification activities as well as during photocopies, pictures, scanned copies, available from your computer, including FDA inspections. It is also critical for microfilm, microfiche, or other accurate records transmitted to your computer documentation and observation of reproductions of the original records); or via a network connection or accessed trends of the food safety risks that may (c) electronic records in compliance

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with part 11. True copies of records accordance with part 11. Comments would require that if your farm is closed should be of sufficient quality to detect should provide the basis for any view for a prolonged period, the records may whether the original record was that the requirements of part 11 are not be transferred to some other reasonably changed or corrected in a manner that warranted. accessible location but must be returned obscured the original entry (e.g., to your farm within 24 hours for official f. Making Records Available for Official through the use of white-out). Proposed Review review upon request. Allowing for § 112.165 would provide flexibility for transfer of records will give practical mechanisms for keeping records while Proposed § 112.166(a) would require storage relief to seasonal operations or maintaining the integrity of the that you have all records required under those closed for other reasons for recordkeeping system. The proposed this part readily available and accessible prolonged periods. Proposed requirement allowing true copies is during the retention period for § 112.166(c) is consistent with our consistent with other regulations such inspection and copying by FDA upon HACCP regulations for seafood and as our Good Manufacturing Practices oral or written request, except that you juice, which provide for transfer of (GMPs) regulation for dietary have 24 hours to obtain records you records for facilities closed for supplements (§ 111.605(b)) and provides keep offsite and make them available prolonged periods (between seasonal options that may be compatible with the and accessible to FDA for inspection packs, in the case of juice) if the records way records are currently being kept in and copying. Our access to records could be immediately returned for plants and facilities. required under this part would expedite official review upon request Proposed § 112.165 also would efforts to document and ensure that (§§ 123.9(b)(3) and 120.12(d)(3) for require that electronic records be kept in covered produce is not adulterated, as seafood and juice, respectively). accordance with part 11 (21 CFR part well as to quickly and accurately 11). Part 11 provides criteria for identify any adulterated covered g. Disclosure Requirements acceptance by FDA, under certain produce and prevent it from reaching Proposed § 112.167 would specify circumstances, of electronic records, consumers. For example, during a that records required by this part are electronic signatures, and handwritten foodborne illness outbreak or subject to the disclosure requirements signatures executed to electronic contamination investigation, records under part 20 of this chapter. FDA’s records as equivalent to paper records access would help enable you and us to regulations in 21 CFR part 20, FOIA, the and handwritten signatures executed on pinpoint the source and cause of Trade Secrets Act [18 U.S.C. 1905], and paper. The proposed requirement contamination in a timely manner. This the FD&C Act govern FDA’s disclosures clarifies and acknowledges that records provision is consistent with our HACCP of information, including treatment of required by part 112 may be retained regulations for juice (§ 120.12(e)) and confidential commercial information electronically, provided that they seafood (§ 123.9(c)), and dietary and trade secret information. Our comply with part 11. supplement GMPs (§ 111.610(b)), which general policies, procedures, and FDA tentatively concludes that it is require that all records required under practices relating to the protection of appropriate to apply the requirements of those rulemakings be available for confidential information received from part 11 to the records that would be review and copying at reasonable times. third parties would apply to information required to be kept under part 112. This provision also is similar to received under this rule. Proposed However, we request comment on requirements in the infant formula § 112.167 is consistent with, but framed whether there are any circumstances quality control procedures regulation differently than, the disclosure that would warrant not applying part 11 (§ 106.100(l)) stating that manufacturers provisions of the HACCP regulations for to records that would be kept under part make readily available for authorized seafood and juice (§§ 123.9(d) and 112. For example, would a requirement inspection all records required under 120.12(f), respectively). Proposed that electronic records be kept according those regulations. In addition, this § 112.167 is framed similarly to the to part 11 mean that current electronic proposed provision is similar to disclosure provisions for records that provisions in the juice HACCP records and recordkeeping systems must be kept under part 118 (Prevention regulation (§ 123.9(f)) and in the would have to be recreated and of Salmonella Enteritidis in Shell Eggs regulation on production, storage, and redesigned, which we determined to be During Production); under § 118.10(f), the case in the regulation Establishment transportation of shell eggs (§ 118.10(d)) records required by part 118 are subject and Maintenance of Records Under the that require that firms be able to retrieve to the disclosure requirements under Public Health Security and Bioterrorism and provide any records stored offsite part 20. Preparedness and Response Act of 2002 within 24 hours of request for official (69 FR 71562; December 9, 2004 (the BT review. P. Subpart P—Variances records regulation))? For the purposes of Proposed § 112.166(b) would require 1. Relevant Provisions of Section 419 of the records requirements in the BT that if you use electronic techniques to the FD&C Act records regulation, we concluded that it keep records, or to keep true copies of was not necessary for new records, or if you use reduction In section 419(c), the FD&C Act recordkeeping systems to be established techniques such as microfilm to keep establishes criteria for the final as long as current practices would true copies of records, that you provide regulation, including that the final satisfy the requirements of the Act and, the records to us in a format in which regulation ‘‘permit States and foreign therefore, we exempted the records from they are accessible and legible. For countries from which food is imported the requirements of part 11 (21 CFR example, you might provide us with an into the United States to request from 1.329(b)). We also exempted records unencrypted copy of an electronic the Secretary variances from the related to certain cattle materials record or provide us with suitable requirements of the regulations, subject prohibited from use in human food and equipment for viewing, printing, and to [section 419(c)(2) of the FD&C Act], cosmetics from part 11 (21 CFR copying a record. This provision would where the State or foreign country 189.5(c)(7) and 700.27(c)(7), enable us to comprehend your records determines that the variance is respectively). We also seek comment on in a timely manner. necessary in light of local growing whether we should allow additional Consistent with proposed conditions and that the procedures, time for electronic records to be kept in § 112.166(a), proposed § 112.166(c) processes, and practices to be followed

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under the variance are reasonably likely procedures and circumstances under would be needed to demonstrate that to ensure that the produce is not which FDA may grant or deny such the variance is necessary in light of local adulterated under section 402 [of the requests, and modify or revoke such growing conditions and that the FD&C Act] and to provide the same variances. Variances approved by FDA procedures, processes, and practices to level of public health protection as the would be limited to the requirements of be followed under the variance are requirements of the regulations adopted part 112 specified by FDA, and have no reasonably likely to ensure that the under [section 419(b) of the FD&C Act]’’ effect on the application of other produce is not adulterated under (section 419(c)(1)(F)). Section 419(c)(2) provisions of the FD&C Act. Section 402 of the Act and provide the specifies the following: Consistent with section 419(c)(2)(A) same level of public health protection as ‘‘REQUESTS FOR VARIANCES.—A of the Act, proposed § 112.171 would the requirements in this rule, when State or foreign country from which establish that a State or foreign country finalized. As discussed in section IV.K, food is imported into the United States from which food is imported into the FDA is proposing extended compliance may in writing request a variance from U.S. may request a variance from one or dates for this proposed rule. We expect the Secretary. Such request shall more of the requirements proposed in that these compliance periods would describe the variance requested and part 112, where the State or foreign allow sufficient time for variance present information demonstrating that country determines that the variance is petitions to be developed, submitted, the variance does not increase the necessary in light of local growing and reviewed by FDA. We request likelihood that the food for which the conditions (proposed § 112.171(a)); and comment on the compliance periods. In proposed § 112.172, we propose to variance is requested will be adulterated the procedures, processes, and practices under section 402, and that the variance establish that a request for a variance, as to be followed under the variance are provides the same level of public health described in proposed § 112.171, must reasonably likely to ensure that the protection as the requirements of the be submitted by the competent authority produce is not adulterated under regulations adopted under [section (e.g., the regulatory authority for food Section 402 of the Act and to provide 419(b) of the FD&C Act]. The Secretary safety) for the state or foreign the same level of public health shall review such requests in a government to FDA in the form of a protection as the requirements of reasonable timeframe’’ (section citizen petition in accordance with 21 proposed part 112 (proposed 419(c)(2)(A)). CFR 10.30. ‘‘APPROVAL OF VARIANCES.—The § 112.171(b)). Such a determination In proposed § 112.173, we propose Secretary may approve a variance in would likely be based on the particular that, in addition to the requirements set whole or in part, as appropriate, and crop, climate, soil, geographic, and forth in § 10.30, the Statement of may specify the scope of applicability of environmental conditions of a particular Grounds (which is specified under a variance to other similarly situated region, as well as processes, procedures, § 10.30(b)) such petition requesting a persons’’ (section 419(c)(2)(B)). or practices followed in that region. variance must include a statement that ‘‘DENIAL OF VARIANCES.—The Given the diversity of covered produce the applicable State or foreign country Secretary may deny a variance request commodities and covered activities has determined that the variance is if the Secretary determines that such subject to the requirements of part 112, necessary in light of local growing variance is not reasonably likely to we tentatively conclude that this conditions and that the procedures, ensure that the food is not adulterated provision provides sufficient flexibility processes, and practices to be followed under section 402 and is not reasonably while ensuring the same level of public under the variance are reasonably likely likely to provide the same level of health protection for covered produce. to ensure that the produce is not public health protection as the For example, a State or foreign country adulterated under Section 402 of the Act requirements of the regulation adopted may consider that the historical and to provide the same level of public under [section 419(b) of the FD&C Act]. performance of an industry within their health protection as the requirements of The Secretary shall notify the person jurisdiction (e.g., as indicated by the this part (proposed § 112.173(a)). In requesting such variance of the reasons epidemiological record) and the addition, the Statement of Grounds for the denial’’ (section 419(c)(2)(C)). combination of measures taken by that would be required to describe with ‘‘MODIFICATION OR REVOCATION industry merits requesting a variance particularity the variance requested, OF A VARIANCE.—The Secretary, after from some or all provisions of this including the persons to whom the notice and an opportunity for a hearing, proposed rule. In requesting a variance, variance would apply and the may modify or revoke a variance if the among other things, the State or foreign provision(s) of part 112 to which the Secretary determines that such variance country would submit information that, variance would apply (proposed is not reasonably likely to ensure that while the procedures, processes and § 112.173(b)); and present information the food is not adulterated under section practices to be followed under the demonstrating that the procedures, 402 and is not reasonably likely to variance would be different from those processes, and practices to be followed provide the same level of public health prescribed in this proposed rule, the under the variance requested are protection as the requirements of the requested variance is reasonably likely reasonably likely to ensure that the regulations adopted under [section to ensure that the produce is not produce is not adulterated under 419(b) of the FD&C Act]’’ (section adulterated under section 402 of the Section 402 of the Act and to provide 419(c)(2)(D)). FD&C Act and provide the same level of the same level of public health public health protection as the protection as the requirements of 2. Proposed Requirements requirements of the final regulations proposed part 112 (proposed Consistent with the statutory (see proposed 112.173). FDA would § 112.173(c)). Under these provisions, a provisions mentioned above, in this encourage consideration of these kinds State or foreign country would be subpart, we propose a process by which of submissions, and welcomes requests required to submit relevant and variances from one or more for pre-petition consultations, including scientifically-valid information or requirements of part 112 may be meetings, with interested States or materials specific to the covered requested by a State or foreign foreign governments to facilitate the produce or covered activity to support government, information that must development of variance petitions, the petitioner’s determination that the accompany such requests, and the including data and information that variance requested is reasonably likely

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to ensure that the produce is not under similar circumstances with specific location who are similarly adulterated under Section 402 of the Act similar procedures, processes, and situated to those identified in the and to provide the same level of public practices as those covered by the petition, we will inform the applicable health protection as the requirements of petition. Proposed § 112.176(c) would State or foreign country where the this part. This would include establish that, under § 10.30(e)(3), FDA similarly situated persons are located of information about the crop, climate, will respond to the petitioner in writing our decision in writing and will publish soil, and geographical or environmental and will publish a notice on our Web a notice on our Web site announcing our conditions of a particular region, as well site announcing our decision to either decision to apply the variance to as the processes, procedures, or grant or deny the petition. Proposed similarly situated persons in that practices followed in that region. § 112.176(c)(1) would establish that, if particular location. We tentatively Proposed § 112.174 establishes our we grant the petition, either in whole or conclude that the provisions in presumption that information submitted in part, we will specify the persons to proposed § 112.177 ensure in a petition requesting a variance and whom the variance would apply and the consideration of the application of comments submitted on such a petition, provision(s) of this part to which the variances to similarly situated persons including a request that a variance be variance would apply. Proposed to and provide for transparency and applied to its similarly situated persons, § 112.176(c)(2) would establish that, if accountability in FDA’s review of does not contain information exempt FDA denies the petition (including requests and decision-making. from public disclosure under part 20 of partial denials), FDA will explain the Proposed § 112.178 would provide this chapter and would be made public reason(s) for the denial in its written that we may deny a variance request if as part of the docket associated with this response to the petitioner and in the it does not provide the information request. We do not believe that notice on our Web site announcing the required under proposed § 112.173 information exempt from disclosure decision to deny. Under proposed (including the requirements of § 10.30), under part 20 of this chapter is the type § 112.176(d), we propose to make or if we determine that the variance is of information that FDA is requiring to readily accessible to the public, and not reasonably likely to ensure that the be submitted in such a petition or that periodically update, a list of filed produce is not adulterated under would be relevant in any comments petitions requesting variances, Section 402 of the Act and to provide submitted on such a petition. We also including the status of each petition (for the same level of public health believe that providing full public access example, pending, granted, or denied). protection as the requirements of this to this information is important to The provisions in proposed § 112.176 part. For example, we would expect to ensuring transparency and for the would ensure transparency in FDA’s deny a petition if the State or foreign opportunity for states and foreign activities and decision-making, which government failed to submit governments to request similar allows the public to better understand scientifically-valid data, information, or variances for similarly situated persons. the agency’s decisions, increasing materials to demonstrate that the Therefore, we expect to make these credibility and promoting procedures, processes, or practices to be submissions publicly available. accountability. followed under the requested variance Proposed § 112.175 would establish are reasonably likely to ensure that the the Director or Deputy Directors of the Proposed § 112.177 would establish produce is not adulterated under Center for Food Safety and Applied circumstances under which an Section 402 of the Act and to provide Nutrition (CFSAN), or the Director of approved variance could apply to any the same level of public health the Office of Compliance, CFSAN as the person other than those identified in the protection as the requirements of responsible official for responding to a petition requesting the variance. Under proposed part 112. request for a variance from one or more proposed § 112.177(a), a State or a Proposed § 112.179 would specify requirements in proposed part 112. foreign country that believes that a that a variance approved by FDA Proposed § 112.176 would establish variance requested by a petition becomes effective on the date of our the general procedures applying to a submitted by another State or foreign written decision on the petition. petition requesting a variance from one country should also apply to similarly Under proposed § 112.180, we would or more requirements in proposed part situated persons in its jurisdiction may be able to modify or revoke an approved 112. Proposed § 112.176(a) would request that the variance be applied to variance if we determine that such provide that the procedures sets forth in its similarly situated persons by variance is not reasonably likely to § 10.30 govern the process by which submitting comments in accordance ensure that the produce is not FDA responds to a petition requesting a with § 10.30. These comments must adulterated under Section 402 of the Act variance. Section 10.30 of this chapter include the information required in and to provide the same level of public specifies the requirements for any § 112.173. If FDA determines that these health protection as the requirements of citizen petition submitted by a person comments should instead be treated as proposed part 112. For example, we (including a petitioner who is not a a separate request for a variance, FDA may deem it necessary to modify terms citizen of the United States) to FDA. will notify the State or foreign country and conditions of the variance based on Proposed § 112.176(b) would establish that submitted these comments that a a review of updated scientific data or that, under § 10.30(h)(3) of this chapter, separate request must be submitted in factual information that is applicable to we will publish a notice in the Federal accordance with §§ 112.172 and the covered produce and procedures, Register, requesting information and 112.173. Moreover, under proposed processes, or practices followed under views on the filed petition, including § 112.177(b), we propose that if we grant the variance. information and views from persons a petition requesting a variance, in Proposed § 112.181 would establish who could be affected by the variance whole or in part, we may specify that the procedures that apply if FDA if the petition were to be granted (either the variance also applies to persons in determines that an approved variance because their farm is covered by the a specific location who are similarly should be modified or revoked. Under petition or as a person similarly situated situated to those identified in the § 112.181(a), we would provide notice to persons covered by the petition). For petition. Consequently, under proposed of such a determination as follows: (1) example, similarly situated persons may § 112.177(c), if we specify that the We will notify a State or a foreign include those whose farm operates variance also applies to persons in a country directly, in writing at the

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address identified in its petition, if we Finally, in proposed § 112.182, we in inspection and enforcement when it determine that a variance granted in would provide examples of permissible comes to foreign farms. FDA’s response to its petition should be types of variances. These examples of inspection resources are very limited, modified or revoked. Our direct, written variances from certain requirements in however, in relation to the number of notification will provide the State or proposed part 112 are consistent with produce farms and the many other food foreign country with an opportunity to our proposed provisions in subpart B for production, processing and storage request an informal hearing under part alternatives from requirements in settings for which FDA has regulatory 16 of this chapter; (2) We will publish proposed part 112. A State or foreign responsibility. Thus, as outlined below, in the Federal Register a notice of our government may request a variance from FDA inspection will play an important determination that a variance should be other requirements in proposed part but necessarily limited role in the modified or revoked. This notice will 112, provided the conditions described overall compliance effort. FDA invites establish a public docket so that in proposed § 112.171 are met. comment on all aspects of its interested parties may submit written compliance strategy. 3. Conforming Amendment to 21 CFR submissions on our determination; and Part 16 2. Education, Technical Assistance and (3) When applicable, we will: (i) Notify Regulatory Guidance in writing any States or foreign We propose to amend § 16.1(b)(1) to countries where a variance applies to include Section 419(c)(2)(D) of the Education and technical assistance is similarly situated persons of our FD&C Act relating to the modification or the foundation of our intended determination that the variance should revocation of a variance from the compliance strategy. As discussed in be modified or revoked; (ii) Provide requirements of Section 419 of the section II.D. above, FDA has, together those States or foreign countries with an FD&C Act, to the list of statutory and with USDA AMS, established a jointly- opportunity to request an informal regulatory provisions under which funded Produce Safety Alliance (PSA), hearing under part 16 of this chapter; regulatory hearings are available. a public-private partnership that will and (iii) Include in the Federal Register develop and disseminate science- and Q. Subpart Q—Compliance and risk-based training and education notice described in paragraph (a)(2) of Enforcement this section public notification of our programs to provide produce growers decision to modify or revoke the 1. Overall Strategy for Implementation and packers with fundamental food variance granted to States or foreign and Compliance safety knowledge. A first phase of PSA’s work is intended to assist farms, countries in which similarly situated FDA expects this proposed rule to especially small and very small farms, persons are located. improve produce safety to the extent the in establishing food safety programs Under § 112.181(b), we would proposed requirements related to consistent with the GAPs Guide and consider submissions from affected practices are actually implemented by other existing guidances so that they States or foreign countries and from farms. Many farms already follow some will be better positioned to comply other interested parties as follows: (1) or all of the proposed practices, but we when we issue a final produce safety We will consider requests for hearings recognize that, when finalized, the rule under section 419 of the FD&C Act. by affected States or foreign countries proposed rule will be the first national As this rulemaking progresses, FDA will under part 16 of this chapter. If FDA standard for on-farm practices related to work to ensure that the PSA materials grants a hearing, we will provide the produce safety and that it will take time are modified, as needed, to be consistent State or foreign country with an and a concerted, community-wide effort with the requirements of the produce opportunity to make an oral submission. for the wide range of farms to come into safety rule. FDA intends to work with We will provide notice on our Web site full compliance. FDA is committed to federal, State, and local officials, of the hearing, including the time, date, working with the produce community industry, and academia through the PSA and place of hearing. If more than one and with partners in the U.S. to assist farmers to implement measures State or foreign country requests an Department of Agriculture, State necessary to minimize the risk of informal hearing under part 16 of this agencies, and foreign governments to serious adverse health consequences or chapter about our determination that a facilitate compliance through education, death from consumption of covered particular variance should be modified technical assistance and regulatory produce. or revoked, we may consolidate such guidance. We also will work to provide requests (for example, into a single We anticipate that compliance will be education and technical assistance hearing); and (2) We will consider achieved primarily through the through other sources of information written submissions submitted to the conscientious efforts of farmers, that are familiar to the produce farming public docket from interested parties. complemented by the efforts of State community (such as Cooperative Under § 112.181(c), we would provide and local governments, extension Extension, land grant universities, trade notice of our final decision as follows: services, private audits and associations, and foreign partners and (1) On the basis of the administrative certifications, and other private sector JIFSAN to reach farmers exporting record, FDA will issue a written supply chain management efforts. We covered produce into the U.S. in their decision, as provided for under part 16 also recognize that the time needed to local languages). We plan to work with of this chapter; and (2) We will publish comply will vary, so we are proposing these and other stakeholders to develop a notice of our decision in the Federal to phase in compliance dates based on a network of institutions that can Register. The effective date of the farm size (see section IV.K of this provide technical assistance to the decision will be the date of publication document). farming community, especially small of the notice. Under the FD&C Act, FDA has and very small farms, as they endeavor We tentatively conclude that these authority to inspect produce farms and to comply with the provisions of the provisions are necessary not only to can take enforcement action when final rule. ensure transparency and accountability needed to prevent significant hazards FDA intends to further facilitate in FDA’s activities and decision-making, from entering the food supply or in compliance with a final produce safety but also to provide relevant parties with response to produce safety problems, rule through the development and an opportunity for due process. although FDA faces severe constraints dissemination of guidance, in multiple

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languages, on procedures, conditions, (CDFA) have developed and are inspections of farms for compliance and practices that farms can implement implementing the California Leafy with a final produce safety regulation. to reduce the risk of known or Greens Marketing Agreement (CA Section 702(a)(1)(A) of the FD&C Act [21 reasonably foreseeable hazards. Section LGMA) to protect public health via U.S.C. 372(a)(1)(A)] expressly authorizes 419(e) of the FD&C Act requires FDA to compliance with the food safety FDA to conduct examinations and develop guidance ‘‘for the safe practices that are accepted by the LGMA investigations for the purposes of the production and harvesting of specific board (Ref. 45). Compliance with such FD&C Act through any health, food, or types of fresh produce under [section practices is further verified for members drug officer or employee of any State, 419]’’ and to hold at least three public and signatories to the agreement Territory, or political subdivision meetings in diverse geographical areas through mandatory government audits thereof (such as a locality), duly of the U.S. as part of an effort to conduct by CDFA auditors who are trained and commissioned to act on behalf of FDA. education and outreach regarding the licensed by USDA AMS (Ref. 263). Qualified State, Territorial, or local guidance. Consistent with this statutory Leafy greens growers in Arizona have regulatory officials may be provision, FDA plans to develop adopted a similar marketing agreement commissioned or serve under contract guidance materials, including additional and audit structure for their growers with FDA to conduct examinations, guidances specific to commodities, (Ref. 32). inspections, and investigations for practices, and conditions, as needed and At the request of industry, the USDA purposes of the FD&C Act. In addition, informed, in part, by stakeholder input, AMS in 2009 held seven hearings section 702(a)(2) [21 U.S.C. 372(a)(2)] including that received during public throughout the United States to solicit expressly authorizes FDA to conduct meetings. input from the leafy greens industries examinations and investigations for the Section 419(a)(4) of FSMA states that across the U.S. regarding their desire to purposes of the FD&C Act through ‘‘the Secretary shall prioritize the develop a proposed national marketing officers and employees of another implementation of the regulations under agreement for leafy greens. A decision Federal department or agency, subject to this section for specific fruits and regarding the proposed USDA AMS certain conditions set forth in that vegetables that are raw agricultural national marketing agreement for leafy section. We expect to continue to commodities based on known risks greens is currently pending, but FDA cooperatively leverage the resources of which may include a history and and USDA are committed to working federal, State, and local government severity of foodborne illness outbreaks.’’ together to harmonize the provisions of agencies in this way as we strive to As discussed immediately above, we any national or regional marketing obtain industry-wide compliance with a intend to fulfill this mandate by (1) agreements for produce with the final produce safety rule. conducting extensive outreach and provisions of any final rule FDA issues Section 419(b)(2)(A) of the FD&C Act educational efforts focused on the under section 419 of the FD&C Act. specifically instructs FDA to ‘‘provide known risks of specific types of produce Rigorous audits conducted under for coordination of education and and specific types of agricultural national or regional marketing enforcement activities by State and local practices applied to such produce; (2) agreements can be an important tool for officials, as designated by the Governors focusing our inspection and fostering compliance with the produce of the respective States or the enforcement efforts on farms that safety rule. appropriate elected State official as present the greatest risk based, in part, FDA also intends to issue notices of recognized by State statute.’’ Consistent on past association with outbreaks, proposed rulemaking implementing with this provision and with the contamination, or the known risks of sections 418 and 805 of the FD&C Act direction to improve the training of their agricultural practices and (sections 103 and 301 of FSMA). FDA is State, local, territorial, and tribal food conditions and/or their specific types of aware of the diversity in quality of safety officials under Section 1011 of produce; and (3) developing guidance audits and the need to strengthen that the FD&C Act (21 U.S.C. 399c, added to materials related to the rule (including system, but we anticipate that audits the FD&C Act by section 209 of FSMA), commodity-specific guidances) focused will be an important source of FDA intends to work closely with on known risks. We request comment accountability for compliance with a extension and education organizations on this approach and on specific final produce safety rule. and State, local, territorial, and tribal strategies we should employ in order to partners to develop the tools and 4. Inspections best prioritize our implementation of training programs needed to facilitate the rule in this manner. With a community as large and consistent inspection and regulatory diverse as the produce farming industry, activities associated with the 3. Supply Chain Management it is not reasonable to expect that requirements of a final produce safety FDA anticipates that significant industry-wide compliance can be gained rule. We expect to build on our incentives and accountability for primarily through inspection and collaboration with State, local, compliance with a final produce safety enforcement, though, of course, territorial, and tribal officials in the rule will come through non-regulatory inspection and enforcement must be a development of tools and training for audits and supply chain management component of our efforts. Inspections use by inspectors in farm investigations initiated by private entities. will, of necessity, be targeted to those on issues specific to food safety during As discussed in section II.F.2. of this farms that present the greatest risk growing, harvest, packing and holding document, a number of retail produce based, in part, on their association with produce. buyers currently require, as a condition past outbreaks or contamination events FDA anticipates that some States may of sale, that their produce suppliers and the risk associated with the choose to adopt requirements modeled comply with and be audited by third agricultural practices they apply in the after the provisions of a final federal parties for conformance with the FDA growing, harvesting, packing, and produce safety rule and may choose to GAPs guide. USDA AMS also offers a holding of covered produce. perform inspections under their own GAPs and Good Handling Practices FDA intends to work collaboratively authorities to enforce those provisions (GAP&GHP) Audit Verification Program. with our federal and State regulatory of their state laws. Such actions would USDA AMS and the California partners to use available inspection further drive compliance with a final Department of Food and Agriculture resources to conduct risk-based federal produce safety rule.

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5. Comments Related to the Proposed compliance with the final regulation. document for further discussion of the Provisions FDA intends to further facilitate process, conditions, and procedures We received many comments on compliance with our final regulation related to a request for variance(s). strategies for compliance, including through the development and In addition to partnering with other comments from farmers, consumers, dissemination of guidance on U.S. agencies and foreign governments, retail, State, federal and foreign procedures, conditions, and practices several comments discussed the governments, academia, trade that farms can implement to reduce the strength of industry programs imposed associations and industry groups, and a risk of known or reasonably foreseeable throughout the supply chain and urged non-profit research and advocacy hazards. us to leverage these private sector organization. These comments broadly Several comments noted that foreign efforts. Some commented on the governments could also play an expressed strategies for compliance that importance of verification of important role in verifying compliance. included specific suggestions on how to compliance by qualified and Some noted that global recognition of ensure that all covered produce is in independent third parties and food safety and food defense efforts compliance with a final rule. Several recognition of third party certification. should be developed. One country comments recognized the importance of These third parties could be those hired specifically requested that we recognize partnerships with respect to bringing by industry, including retailers, to foreign fresh produce initiatives as about compliance with, and ultimately ensure the safety of produce from their equivalent oversight of the industry. suppliers. However, some comments enforcing, a final rule. Comments urged We agree that foreign governments the agency to work in cooperation with identified duplicative audits and will play an important part in bringing excessive documentation as other federal, State, Territorial, tribal about compliance with a final produce and local agencies with jurisdiction and problematic, particularly for small rule with respect to foreign products. growers. Other comments recognized expertise to ensure a coordinated and We have already begun to reach out to uniform approach to enforcement and that importers can play an important foreign governments regarding the role in verifying compliance with a final compliance that will improve efficiency requirements of FSMA and will and effectiveness. Several comments produce safety rule and safety of continue to provide technical assistance imported produce. noted that governmental testing as we move closer to finalizing rules We agree that we should leverage the laboratories should be recognized and issued under FSMA authorities. There efforts of private supply chain funding should be provided to States to are several provisions of FSMA that management to further compliance with hire and train auditors. directly relate to these partnerships. a final rule in this area. See discussion We agree that partnerships will play Section 305 of FSMA specifically of our overall enforcement and a crucial role in bringing the produce directs us to develop a plan to build the industry into compliance with a final capacity of foreign governments with compliance strategy immediately above. rule. As discussed in our overall respect to food safety that will include, We also agree that importers will play strategy above and reflected in proposed among other things, training of foreign an important role in ensuring the safety 112.193, FDA intends to work with governments on our requirements, of produce grown in other countries and State, Territorial, tribal, and local provisions for mutual recognition of shipped to the United States. Under partners to develop the education and inspection reports, and provisions for section 301 of FSMA, importers will enforcement tools and training programs multilateral acceptance of laboratory have to verify that imported covered needed to facilitate consistent methods and testing and detection produce is produced in compliance inspection and regulatory activities techniques. Under section 307 of FSMA, with processes and procedures that associated with the requirements of a which added section 808 to the FD&C provide the same level of public health final produce safety rule. Education and Act [21 U.S.C. 384d], we are directed to protection as those required under outreach through mechanisms like PSA establish a system for the recognition of section 419 of the FD&C Act. and other sources of information that accreditation bodies that accredit third- Other comments noted that are familiar to the produce farming party auditors to certify that eligible compliance with produce safety community (such as Cooperative entities meet certain requirements. requirements should be tiered to reflect Extension, land grant universities, and Under that section, foreign governments farm size, market requirements and risk. trade associations) are the foundation of or agencies of foreign governments, may One comment noted that there should our intended compliance strategy. We be accredited as third party auditors be dedicated inspectors for identified also plan to work with these and other who could help to ensure compliance groups that may need additional stakeholders to develop a network of with a final produce safety rule. Section assistance. institutions that can provide technical 303 of FSMA amended section 801 of We agree that we should prioritize our assistance to the farming community, the FD&C Act to, among other things, compliance and enforcement efforts. As especially small and very small farms, allow us to designate an agency or discussed above, we will be targeting as they endeavor to comply with the representative of the foreign government our education efforts to the smaller provisions of a final rule. Of course, of the country from which a food businesses that may not be as familiar although much of our initial effort will originated to provide certification or with our requirements as some of the be focused on education and outreach, other assurances that certain foods are larger farms. We also propose to give we will also inspect farms on a targeted in compliance with the FD&C Act, if small and very small businesses extra basis for compliance with a final FDA chooses to require such time to comply with the final rule, as produce safety rule. Partnerships will certifications or assurances for certain discussed in section IV.K of this play an important role with regard to foods. We are working to implement document. With respect to inspections, inspections as well. FDA intends to these provisions of FSMA. In addition, they will, of necessity, be targeted to work collaboratively with our federal, as set forth in subpart P of this proposed those farms that present the greatest risk State, Territorial, tribal, and local rule, foreign countries may request based, in part, on their association with regulatory partners to use available variances from requirements proposed past outbreaks or contamination events inspection resources to conduct risk- in this rule, provided they meet certain and the risk associated with the based inspections of farms for conditions. See section V.P. of this agricultural practices they apply in the

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growing, harvesting, packing, and Act provides that FDA shall establish in and local partners to develop the holding of covered produce. this rulemaking ‘‘procedures, processes, education and enforcement tools and A few comments mentioned that and practices that the Secretary training programs needed to facilitate research can play an important part in determines to be reasonably necessary consistent inspection and regulatory bringing about industry compliance. * * * to provide reasonable assurances activities associated with the Some noted that foodborne illness that the produce is not adulterated requirements proposed in subparts A outbreak investigations needed to be under section 402 [of the FD&C Act]’’ through O. improved and used as educational and that similar references to preventing R. Subpart R—Withdrawal of Qualified opportunities to support food safety adulteration under section 402 of the Exemption research. They noted that better FD&C Act also appear in section investigative methods should be 419(c)(1)(F), (c)(2)(A), (c)(2)(C), and As proposed, subpart R establishes developed to help reveal possible (c)(2)(D). In sections V.A. through V.O. the procedures that would govern the sources of contamination. FDA agrees, of this document, we explain how the circumstances and process whereby we as reflected in the recent establishment proposed provisions are necessary to may issue an order withdrawing a of the Coordinated Outbreak Response protect against contamination with qualified exemption applicable to a farm and Evaluation (CORE) Network, which hazards that may adulterate food. We in accordance with the requirements of is a permanent cadre of FDA experts tentatively conclude that the link § 112.5. Specifically, proposed § 112.201 whose full time responsibility is to between the proposed provisions and lists the circumstances under which enhance outbreak detection, response, the potential for adulteration provides a FDA can withdraw a qualified and follow up investigations to inform basis for applying the criteria and exemption applicable to a farm, while future prevention efforts. CORE will definitions in proposed part 112 in §§ 112.202 and 112.203 specify the work with CDC, state and local partners, determining whether, under particular procedure and information that FDA and the food industry to investigate root circumstances, a food is adulterated would include in an order to withdraw causes of major outbreaks and share under section 402(a)(3) or (a)(4) or in such qualified exemption. In addition, findings with the food safety violation of section 361 of the PHS Act. proposed §§ 112.204 through 112.207 community. We also note 402(a)(4) of the FD&C Act provide for a process whereby you may Comments also noted that a provides that food is adulterated if it has submit a written appeal (which may permanent institutional part of been ‘‘prepared, packed, or held under include a request for a hearing) of an government should be developed to insanitary conditions’’ whereby either of order to withdraw a qualified exemption coordinate research, information, the proscribed results may occur. applicable to your farm, and proposed responses to, and control measures for, ‘‘Prepared, packed, or held’’ includes §§ 112.208 through 112.211 provide a human pathogens and their evolution in growing, harvesting, packing, and procedure for appeals, hearings, and the environment, including the farm holding. The common meaning of decisions on appeals and hearings. environment, animal production, the ‘‘prepare,’’ as represented by the 1. Requirements of Section 419 of the industrial and commercial environment dictionary definition is, in relevant part, FD&C Act and the medical (healthcare) system. As ‘‘to make ready beforehand for some discussed previously, we are pursuing purpose, use, or activity * * * to put Section 419(f)(3)(A) of the FD&C Act regulatory science and research together’’ (Ref. 264). Growing and specifies that, ‘‘[i]n the event of an activities in collaboration with various harvesting are operations that make food active investigation of a foodborne partners. See section II.E. of this ready for use as food. In addition, illness outbreak that is directly linked to document for further information. growing and harvesting at times involve a farm subject to an exemption under [section 419(f) of the FD&C Act], or if 6. Proposed Requirements holding of food. Section 105(c) of FSMA amends the Secretary determines that it is Proposed § 112.191 states that the section 301 of the FD&C Act (21 U.S.C. necessary to protect the public health criteria and definitions in this part 331) by adding a new section—(vv)—to and prevent or mitigate a foodborne apply in determining whether a food is the list of acts and the causing thereof illness outbreak based on conduct or adulterated (1) within the meaning of that are prohibited. Under section conditions associated with a farm that section 402(a)(3) of the Federal Food, 301(vv), the following act, and the are material to the safety of the food Drug, and Cosmetic Act in that the food causing thereof, is prohibited: ‘‘[t]he produced or harvested at such farm, the has been grown, harvested, packed, or failure to comply with the requirements Secretary may withdraw the exemption held under such conditions that it is under section 419 [of the FD&C Act].’’ provided to such farm under [section unfit for food; or (2) within the meaning To clearly communicate that failure to 419(f) of the FD&C Act].’’ Section 419 of section 402(a)(4) of the Federal Food, comply with regulations established does not expressly prescribe the Drug, and Cosmetic Act in that the food under section 419 is a prohibited act, procedures for withdrawing a qualified has been prepared, packed, or held proposed § 112.192 would establish that exemption provided to a farm under under insanitary conditions whereby it the failure to comply with the section 419(f). We tentatively conclude may have become contaminated with requirements of part 112, issued under that it is appropriate to be transparent filth, or whereby it may have been section 419 of the Federal Food, Drug, about the process we would use to rendered injurious to health. The and Cosmetic Act, is a prohibited act withdraw a qualified exemption and criteria and definitions in this part also under section 301(vv) of the Federal that we should include the process in apply in determining whether a food is Food, Drug, and Cosmetic Act (21 U.S.C. the proposed rule. in violation of section 361 of the Public 331(vv)). 2. Proposed Requirements Health Service Act (42 U.S.C. 264). Proposed § 112.193 provides that As discussed in section III of this under Section 419(b)(2)(A) of the FD&C a. Circumstances for Withdrawal document, FDA proposes these Act, FDA coordinates education and Proposed § 112.201 would establish regulations under the FD&C Act as enforcement activities by State, the circumstances under which FDA amended by FSMA, and the Public Territorial, tribal, and local officials. As can withdraw an exemption applicable Health Service Act (PHS Act). We note described above, we plan to work to a farm. Consistent with Section that section 419(c)(1)(A) of the FD&C closely with State, Territorial, tribal, 419(f)(3)(A) of the FD&C Act, it states

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that we may withdraw your qualified to the safety of the food that would withdrawal order by a District Director exemption under proposed § 112.5: otherwise be covered produce grown, or an FDA official senior to a District (1) In the event of an active harvested, packed, or held at such farm. Director is consistent with the approval investigation of a foodborne illness As an example, we may receive reports requirement for a detention order in part outbreak that is directly linked to your to the Reportable Food Registry under 1, subpart K (Administrative Detention farm (proposed § 112.201(a)); or section 417 of the FD&C Act about of Food for Human or Animal (2) If we determine that it is necessary contamination of a food, and the reports Consumption). Requiring prior approval to protect the public health and prevent may lead us to investigate a farm that of a withdrawal order by the Director of or mitigate a foodborne illness outbreak grew, harvested, packed or held the the Office of Compliance in the Center based on conduct or conditions food. If our investigation finds conduct for Food Safety and Applied Nutrition associated with your farm that are or conditions associated with the farm is consistent with current FDA practices material to the safety of the food that that are material to the safety of the food when dealing with foreign firms. would otherwise be covered produce that would otherwise be covered Proposed § 112.202(c) would require grown, harvested, packed or held at produce subject to proposed subparts B that FDA issue an order to withdraw the your farm (proposed § 112.201(b)). through O of this rule (for example, exemption to the owner, operator, or Proposed § 112.201(a) would conduct or conditions that likely led to agent in charge of the farm. We implement the statutory language of the contamination of the food), we tentatively conclude that it would be section 419(f)(3)(A) of the FD&C Act. An would consider withdrawing the appropriate for FDA to issue an outbreak of foodborne illness is the qualified exemption applicable to the exemption withdrawal order to any of occurrence of two or more cases of a farm under proposed § 112.5 if doing so these persons. Proposed § 112.202(d) similar illness resulting from the would be necessary to protect the public would require that FDA issue an order ingestion of a common food. Food can health and prevent or mitigate a to withdraw the exemption in writing, become contaminated at many different foodborne illness outbreak. Likewise, if signed and dated by the officer or steps in the farm-to-table continuum: during a routine inspection of a farm to qualified employee of FDA who is On the farm; in packing, manufacturing/ which the qualified exemption in issuing the order. processing, or distribution facilities; proposed § 112.5 applies, we discover during storage or transit; at retail conditions and practices that are likely c. Information Included in FDA’s establishments; in restaurants; and in to lead to contamination of food that Withdrawal Order the home. When foodborne illness is would otherwise be covered produce Proposed § 112.203(a) through (h) associated with food, an investigation with microorganisms of public health would require that an order to withdraw may enable us to directly link the illness significance, we would consider a qualified exemption applicable to a to the farm that grew, harvested, packed, withdrawing the qualified exemption farm under § 112.5 include the and/or held the food. provided to the facility under proposed following information: Proposed § 112.201(b) would also § 112.5 if doing so would be necessary (a) The date of the order (proposed implement the statutory language of to protect the public health and prevent § 112.203(a)); section 419(f)(3)(A) of the FD&C Act, or mitigate a foodborne illness outbreak. (b) The name, address and location of which provides that FDA may withdraw the covered farm (proposed a qualified exemption available to a b. Procedure for Issuance of Withdrawal Order § 112.203(b)); farm under section 419(f) ‘‘if the (c) A brief, general statement of the Secretary determines that it is necessary Proposed § 112.202(a) would provide reasons for the order, including to protect the public health and prevent that, if FDA determines that a qualified information relevant to: or mitigate a foodborne illness outbreak exemption applicable to a farm under (1) An active investigation of a based on conduct or conditions § 112.5 should be withdrawn, any foodborne illness outbreak that is associated with a farm that are material officer or qualified employee of FDA directly linked to the farm; or to the safety of the food produced or may issue an order to withdraw the (2) Conduct or conditions associated harvested at such farm.’’ We tentatively exemption. We intend to create and with a farm that are material to the conclude that the food to which this maintain a written record of a safety of the food that would otherwise standard applies is food that would determination that the withdrawal of an be covered produce grown, harvested, otherwise be covered produce, because exemption is warranted and to include packed and held at such farm (proposed that is the food that would be subject to the basis for the determination in the § 112.203(c)); this proposed rule if a qualified written record. Proposed § 112.202(b) (d) A statement that the farm must exemption is withdrawn. We also would require that an FDA District comply with subpart B through subpart tentatively conclude that it is reasonable Director in whose district the farm is O of this part on the date that is 60 to interpret the word ‘‘produced’’ in this located (or, in the case of a foreign farm, calendar days after the date of the order standard to refer to the activities within the Director of the Office of Compliance (proposed § 112.203(d)); the farm definition other than in the Center for Food Safety and (e) The text of section 419(f) of the harvesting, because this proposed rule Applied Nutrition), or an FDA official Federal Food, Drug, and Cosmetic Act would apply only to activities within senior to such Director, must approve an and of subpart R of the rule (proposed the farm definition and the standard order to withdraw the exemption as part § 112.203(e)); already uses the word ‘‘harvested.’’ of the withdrawal determination (f) A statement that any informal Thus, proposed § 112.201(b) would procedure before the order is issued. A hearing on an appeal of the order must provide that FDA may withdraw the Regional Food and Drug Director is an be conducted as a regulatory hearing qualified exemption applicable to a farm example of an FDA official senior to a under part 16 (21 CFR Part 16), with under proposed § 112.5 if FDA District Director. The Deputy Directors certain exceptions described in determines that it is necessary to protect and Director of the Center for Food proposed § 112.208 (proposed the public health and prevent or Safety and Applied Nutrition are § 112.203(f)); mitigate a foodborne illness outbreak examples of an FDA official senior to (g) The mailing address, telephone based on conduct or conditions the Director of the Office of Compliance. number, email address, and facsimile associated with a farm that are material Requiring prior approval of a number of the FDA district office and

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the name of the FDA District Director in e. Procedure for Appealing a flexibility as well as speed. For whose district the farm is located (or, in Withdrawal Order (Including Requests example, submitting in person would the case of a foreign farm, the same for Informal Hearing) give the owner, operator, or agent in information for the Director of the Office Proposed § 112.205(a) would establish charge direct knowledge that the request of Compliance in the Center for Food that submission of an appeal, including for appeal had been delivered and Safety and Applied Nutrition); submission of a request for an informal received. Email and fax are (proposed § 112.203(g)); and hearing, will not delay or stay any instantaneous, and overnight mail delivery services are readily available to (h) The name and the title of the FDA administrative action, including those who choose to use them; however, representative who approved the order enforcement action by FDA, unless the the ten day time frame for appeal of the (proposed § 112.203(h)). Commissioner of Food and Drugs, as a order would not require the use of FDA tentatively concludes that the matter of discretion, determines that delay or a stay is in the public interest. overnight mail delivery. For clarity, requirements that we propose in For example, the submission of an proposed § 112.206(a)(1) would repeat § 112.203 would provide the owner, appeal of a withdrawal order with a the 10 calendar day time frame that operator, or agent in charge of a farm request for an informal hearing would would be established in proposed subject to a withdrawal with adequate not prevent FDA from simultaneously § 112.204 and would not establish any notice of the basis for our determination detaining food from the farm under new requirement. Any appeal would to withdraw the exemption and of their need to be written in order for FDA to section 304(h) of the FD&C Act, seeking opportunity to appeal our determination evaluate the basis for the appeal. We are seizure of food from the farm under and to request an informal hearing. The proposing that a written appeal would section 304(a) of the FD&C Act, or proposed notification procedures are need to address with particularity all of seeking or enforcing an injunction similar to and consistent with the the issues raised in the withdrawal under section 302 of the FD&C Act. order and include all supporting notification requirements in other Proposed § 112.205(b) would require documentation so that we would be able regulations involving administrative that, if the owner, operator, or agent in to issue a final determination as to the action, such as administrative detention charge of the farm appeals the order, disposition of the appeal solely on the of food under § 1.393, orders for and FDA confirms the order, the owner, basis of the materials submitted as part diversion or destruction of shell eggs operator, or agent in charge of the farm under the PHS Act under § 118.12(a)(i), of the written appeal. must comply with applicable Proposed § 112.206(b) would provide and with procedures for an informal requirements of this part within 60 hearing in part 16. We seek comments that, in a written appeal of the order calendar days of the date of the order or, withdrawing an exemption provided on the proposed process for withdrawal if operations have ceased and will not of a qualified exemption. under § 112.5, the owner, operator, or resume within 60 calendar days, before agent in charge of the farm may include d. Requirements When a Withdrawal the beginning of operations in the next a written request for an informal hearing Order Is Issued growing season. Proposed § 112.205(b) as provided in § 112.207. Requesting an would make clear that the 60 calendar informal hearing does not mean that a Proposed § 112.204 would require day time frame for compliance applies hearing will be held, because we may that the owner, operator, or agent in regardless of whether the owner, deny the request (see discussion of charge of a farm that receives an order operator, or agent in charge of a farm proposed § 112.207(b) below). However, to withdraw an exemption applicable to requests, and FDA grants, a hearing. As if the owner, operator, or agent in charge that farm under § 112.5 either (a) already discussed, FDA tentatively of the farm does not request an informal comply with applicable requirements of concludes that the circumstances that hearing at the time the written appeal is this part within 60 calendar days of the lead to a determination that an submitted, the owner, operator, or agent date of the order or, if operations have exemption should be withdrawn in charge of the farm will not be entitled ceased and will not resume within 60 warrant prompt compliance in the to an informal hearing. Instead, FDA calendar days, before the beginning of interest of public health. will make a final decision based on the operations in the next growing season; Proposed § 112.206(a) would require written appeal and its supporting or (b) appeal the order within 10 that, to appeal an order to withdraw a materials. calendar days of the date of the order in qualified exemption applicable to a farm Proposed § 112.207(a)(1) would accordance with the requirements of under § 112.5, the owner, operator, or provide that, if the owner, operator, or § 112.206. We tentatively conclude that agent in charge of the farm must: (1) agent in charge of the farm appeals the either of the two circumstances that Submit the appeal in writing to the FDA order, the owner, operator, or agent in could result in our determination that District Director in whose district the charge of the farm may request an an exemption should be withdrawn (as farm is located (or, in the case of a informal hearing. Proposed described in proposed § 112.201) foreign farm, to the Director of the § 112.207(a)(1) would restate an option warrant prompt compliance with the Office of Compliance in the Center for that would be included in proposed rule in the interest of public health. We Food Safety and Applied Nutrition), at § 112.206(b) to highlight the opportunity tentatively conclude that ten calendar the mailing address, email address, or to request an informal hearing. Proposed days for the submission of an appeal facsimile number identified in the order § 112.207(a)(2) would require that, if the from the date of the receipt of a within 10 calendar days of the date of owner, operator, or agent in charge of withdrawal order is appropriate for the order; and (2) respond with the farm appeals the order, the owner, purposes of the efficient adjudication of particularity to the facts and issues operator, or agent in charge of the farm the appeal of a withdrawal order and contained in the order, including any must submit any request for an informal would provide reasonable due process supporting documentation upon which hearing together with its written appeal that comes to closure sufficiently in the owner, operator or agent in charge submitted in accordance with § 112.206 advance of the effective date of the order of the farm relies. Allowing the owner, within 10 calendar days of the date of to provide an opportunity for the farm operator, or agent in charge of the farm the order. We tentatively conclude that to come into compliance if we deny the to submit an appeal in person, by mail, requiring submission of a request for an appeal. email, or fax would provide for informal hearing in writing at the time

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that the owner, operator, or agent in Proposed 112.208(b) would establish (6) No party shall have the right, charge of the farm would be required to that the presiding officer may require under § 16.119 of this chapter to submit a written appeal is appropriate that a hearing conducted under this petition the Commissioner of Food and for purposes of the efficient subpart be completed within 1 calendar Drugs for reconsideration or a stay of the adjudication of the appeal of a day, as appropriate. We tentatively presiding officer’s final decision. withdrawal order and would provide conclude that, if we grant a request for (7) If FDA grants a request for an reasonable due process that would come an informal hearing, limiting the time informal hearing on an appeal of an to closure sufficiently in advance of the for the hearing itself to be completed order withdrawing an exemption, the effective date of the order to provide an within 1 calendar day is appropriate for hearing must be conducted as a opportunity for the farm to come into purposes of the efficient adjudication of regulatory hearing pursuant to compliance if we deny the appeal. the appeal of a withdrawal order and regulation in accordance with part 16, Proposed § 112.207(b) would establish would provide reasonable due process except that § 16.95(b) does not apply to that a request for an informal hearing that would come to closure sufficiently a hearing under this subpart. With may be denied, in whole or in part, if in advance of the effective date of the respect to a regulatory hearing under the presiding officer determines that no order to provide an opportunity for the this subpart, the administrative record genuine and substantial issue of farm to come into compliance if we of the hearing specified in material fact has been raised by the deny the appeal. §§ 16.80(a)(1), (a)(2), (a)(3), and (a)(5), material submitted. Proposed Proposed § 112.208(c)(1) through (7) and 112.208(c)(5) constitutes the § 112.207(b) would also provide that if would establish that, if the owner, exclusive record for the presiding the presiding officer determines that a operator or agent in charge of the farm officer’s final decision. For purposes of hearing is not justified, written notice of requests an informal hearing, and FDA judicial review under § 10.45 of this the determination will be given to the grants the request, FDA must conduct chapter, the record of the administrative proceeding consists of the record of the owner, operator, or agent in charge of the hearing in accordance with part 16, hearing and the presiding officer’s final the farm explaining the reason for the except that: (1) The order withdrawing an decision. denial. Under proposed § 112.206(a), a Under § 16.1(b), the procedures in exemption under § 112.5, rather than written appeal would be required to part 16 apply when a regulation the notice under § 16.22(a), provides respond with particularity to the facts provides a person with an opportunity notice of opportunity for a hearing and issues contained in the withdrawal for a hearing on a regulatory action under this section and is part of the order, including any supporting under part 16. Section 419 of the FD&C administrative record of the regulatory documentation upon which the owner, Act does not expressly provide for a hearing under § 16.80(a) of this chapter. operator or agent in charge of the farm hearing if circumstances lead FDA to relies. If the materials submitted do not (2) A request for a hearing under this determine that a qualified exemption directly address the facts and issues subpart must be addressed to the FDA provided to a farm under proposed contained in the withdrawal order in a District Director (or, in the case of a § 112.5 should be withdrawn. However, manner that suggests that there is a foreign farm, the Director of the Office we tentatively conclude as a matter of genuine dispute regarding the material of Compliance in the Center for Food agency discretion that providing an facts contained in the order, the Safety and Applied Nutrition) as opportunity for a hearing by regulation presiding officer may determine that an provided in the order withdrawing an in this subpart of the proposed rule informal hearing is not warranted. The exemption. would provide appropriate process to presiding officer may include written (3) Section 112.209, rather than the owner, operator, or agent in charge notice of the determination that a § 16.42(a), describes the FDA employees of a farm subject to withdrawal of the hearing is not justified as part of the who preside at hearings under this farm’s qualified exemption. We also final decision on the appeal. subpart. tentatively conclude that the modified (4) Section 16.60(e) and (f) of this f. Procedure for Appeals (Including part 16 procedures contained in this chapter does not apply to a hearing Informal Hearings) proposed rule would provide the owner, under this subpart. The presiding officer operator, or agent in charge of a farm Proposed § 112.208(a) would establish must prepare a written report of the subject to a withdrawal order sufficient that, if the owner, operator or agent in hearing. All written material presented fairness and due process while enabling charge of the farm requests an informal at the hearing will be attached to the FDA to expeditiously adjudicate an hearing, and FDA grants the request, the report. The presiding officer must appeal of a withdrawal order for which hearing will be held within 10 calendar include as part of the report of the an informal hearing has been granted. days after the date the appeal is filed or, hearing a finding on the credibility of We seek comment on this proposed if applicable, within a time frame agreed witnesses (other than expert witnesses) process. upon in writing by the owner, operator, whenever credibility is a material issue, Section 16.119 provides that, after any or agent in charge of the farm and FDA. and must include a proposed decision, final administrative action that is the We tentatively conclude that, if we grant with a statement of reasons. The hearing subject of a hearing under part 16, any a request for an informal hearing, participant may review and comment on party may petition the Commissioner for holding the hearing within 10 calendar the presiding officer’s report within 2 reconsideration of any part or all of the days, or within an alternative time calendar days of issuance of the report. decision or action under § 10.33 or may frame as agreed upon in writing, is The presiding officer will then issue the petition for a stay of the decision or appropriate for purposes of the efficient final decision. action under § 10.35. Proposed adjudication of the appeal of a (5) Section 16.80(a)(4) of this chapter § 112.208(c)(6) would specify that these withdrawal order and would provide does not apply to a regulatory hearing procedures for reconsideration and stay reasonable due process that would come under this subpart. The presiding would not apply to the process of to closure sufficiently in advance of the officer’s report of the hearing and any withdrawing a qualified exemption effective date of the order to provide an comments on the report by the hearing provided under proposed § 112.5. The opportunity for the farm to come into participant under § 112.208(c)(4) are circumstances that may lead FDA to compliance if we deny the appeal. part of the administrative record. withdraw a qualified exemption include

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an active investigation of a foodborne presiding officer must issue a written within 10 calendar days after the date illness outbreak that is directly linked to report that includes a final decision the appeal is filed. We tentatively a farm, or our determination that it is confirming or revoking the withdrawal conclude that ten calendar days for the necessary to protect the public health by the tenth calendar day after the presiding officer to issue a final decision and prevent or mitigate a foodborne appeal is filed. Under proposed is appropriate for purposes of the illness outbreak based on conduct or § 112.201, FDA would issue a efficient adjudication of the appeal of a conditions associated with a farm that withdrawal order either in the event of withdrawal order, would provide are material to the safety of the food that an active investigation of a foodborne reasonable due process that would come would otherwise be covered produce illness outbreak that is directly linked to to closure sufficiently in advance of the grown, harvested, packed, or held at a farm or if we determine that an effective date of the order to provide an such farm. Such circumstances require exemption withdrawal is necessary to opportunity for the farm to come into prompt action. Under § 16.120, a farm protect the public health and prevent or compliance if we deny the appeal, and that disagrees with FDA’s decision to mitigate a foodborne illness outbreak is in the interest of public health. withdraw an exemption provided under based on conduct or conditions i. Revocation of Withdrawal Order § 112.5 has an opportunity for judicial associated with a farm that are material review in accordance with § 10.45. to the safety of the food that would Proposed § 112.211(a) through (c) otherwise be covered produce grown, would establish that an order to g. Presiding Officer harvested, packed, or held by the farm. withdraw a qualified exemption Proposed § 112.209 would require We tentatively conclude that we will applicable to a farm under § 112.5 is that the presiding officer for an appeal, need 10 calendar days to review the revoked if: and for an informal hearing, must be an written appeal and the materials (a) The owner, operator, or agent in FDA Regional Food and Drug Director submitted with the written appeal, and charge of the farm appeals the order and or another FDA official senior to an FDA that a final decision confirming or requests an informal hearing, FDA District Director. Under § 16.42(b), an revoking a withdrawal order should be grants the request for an informal officer presiding over an informal issued as quickly as possible in the hearing, and the presiding officer does hearing is to be free from bias or interest of the public health and to not confirm the order within the 10 prejudice and may not have participated provide reasonable due process that calendar days after the hearing, or issues in the investigation or action that is the would come to closure sufficiently in a decision revoking the order within subject of the hearing or be subordinate advance of the effective date of the order that time (proposed § 112.211(a)); or to a person, other than the to provide an opportunity for the farm (b) The owner, operator, or agent in Commissioner, who has participated in to come into compliance if we deny the charge of the farm appeals the order and such investigation or action. An order appeal. requests an informal hearing, FDA for the withdrawal of a qualified Proposed § 112.210(b)(1) would denies the request for an informal exemption applicable to a farm must be require that, if the owner, operator, or hearing, and FDA does not confirm the approved by a District Director or an agent in charge of a farm appeals the order within the 10 calendar days after official senior to a District Director. It is, order and requests an informal hearing the appeal is filed, or issues a decision therefore, necessary that appeals of a and, if FDA grants the request for a revoking the order within that time decision to issue a withdrawal order hearing and the hearing is held, the (proposed § 112.211(b)); or should be handled by persons in presiding officer must provide a 2 (c) The owner, operator, or agent in positions senior to the District Directors. calendar day opportunity for the hearing charge of the farm appeals the order The Regional Food and Drug Director is participants to review and submit without requesting an informal hearing, such a person and could be from the comments on the report of the hearing and FDA does not confirm the order same region where the farm is located, under § 112.208(c)(4), and must issue a within the 10 calendar days after the provided that the Regional Food and final decision within the 10-calendar appeal is filed, or issues a decision Drug Director did not participate in the day period after the hearing is held. We revoking the order within that time determination that an exemption should tentatively conclude that it is (proposed § 112.211(c)). be withdrawn and is otherwise free from appropriate to grant the owner, operator, We tentatively conclude that an order bias or prejudice. Alternatively, the or agent in charge of a farm subject to to withdraw an exemption may be Regional Food and Drug Director could a withdrawal order the opportunity to revoked in one of two manners. First, be from a different region than the review and submit comments to the we are proposing that the FDA officer region where the farm is located, for presiding officer’s report because the responsible for adjudicating the appeal example in the event the Regional Food report is part of the record of a final and presiding over a hearing, if one is and Drug Director for the region in agency action (see discussion of granted, may expressly issue a written which the farm is located is the FDA proposed § 112.211(d)) that is not decision revoking the order within the official who approved the withdrawal subject to further reconsideration by specified 10 calendar day time frame. order. Any Office Director of FDA’s FDA. The presiding officer would have Second, we are proposing that the Office of Regulatory Affairs could discretion to determine whether to failure of the FDA officer responsible for preside at a hearing, provided that the revise the report of the hearing in light adjudicating an appeal to issue a final Office Director did not participate in the of any comments that might be decision expressly confirming the order determination that an exemption should submitted by any of the hearing within the specified time frames will be withdrawn and is otherwise free from participants. also serve to revoke the order. We bias or prejudice. Proposed § 112.210(b)(2) would tentatively conclude that fairness would require that, if the owner, operator, or warrant the revocation of a withdrawal h. Decisions on Appeals (Including agent in charge of a farm appeals the order if FDA is unable to meet the Informal Hearings) order and requests an informal hearing proposed deadlines for expressly Proposed § 112.210(a) would require and if FDA denies the request for a confirming an order. that, if the owner, operator, or agent in hearing, the presiding officer must issue Proposed § 112.211(d) would charge of a farm appeals the order a final decision on the appeal establish that confirmation of a without requesting a hearing, the confirming or revoking the withdrawal withdrawal order by the presiding

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officer is considered a final agency prices; significant adverse effects on [email protected]. All action for purposes of section 702 of competition, employment, productivity, comments should be identified with the title 5 of the United States Code (5 or innovation; or significant adverse title ‘‘Standards for the Growing, U.S.C. 702). A confirmation of an order effects on the ability of United States- Harvesting, Packing, and Holding of withdrawing an exemption therefore based enterprises to compete with Produce for Human Consumption.’’ In would be reviewable by the courts foreign-based enterprises in domestic or compliance with the Paperwork under section 702 of title 5 and in export markets. In accordance with the Reduction Act of 1995 (44 U.S.C. accordance with § 10.45 (21 CFR 10.45). Small Business Regulatory Enforcement 3407(d)), the Agency has submitted the Fairness Act, the Office of Management information collection provisions of this 3. Conforming Amendment to 21 CFR and Budget (OMB) has determined that proposed rule to OMB for review. These Part 16 this proposed rule is a major rule for the requirements will not be effective until We propose to amend § 16.1(b)(2) to purpose of congressional review. FDA obtains OMB approval. FDA will include part 112, subpart R, relating to publish a notice concerning OMB D. Unfunded Mandates Reform Act of the withdrawal of a qualified exemption approval of these requirements in the 1995 applicable to a farm, to the list of Federal Register. regulatory provisions under which Section 202(a) of the Unfunded regulatory hearings are available. Mandates Reform Act of 1995 requires F. Public Access to the Analyses that agencies prepare a written The analyses that FDA has performed VI. Preliminary Regulatory Impact statement, which includes an in order to examine the impacts of this Analysis assessment of anticipated costs and proposed rule under Executive Order A. Overview benefits, before proposing ‘‘any rule that 12866, Executive Order 13563, the FDA has examined the impacts of this includes any Federal mandate that may Regulatory Flexibility Act (5 U.S.C. proposed rule under Executive Order result in the expenditure by State, local, 601–612), the Unfunded Mandates 12866, Executive Order 13563, the and tribal governments, in the aggregate, Reform Act of 1995 (Pub. L. 104–4), and Regulatory Flexibility Act (5 U.S.C. or by the private sector, of $100,000,000 the Paperwork Reduction Act of 1995 601–612), and the Unfunded Mandates or more (adjusted annually for inflation) (44 U.S.C. 3501–3520) are available to Reform Act of 1995 (Pub. L.104–4). in any one year.’’ The current threshold the public in the docket for this Executive Orders 12866 and 13563 after adjustment for inflation is $136 proposed rule (Ref. 265). million, using the most current (2010) direct agencies to assess all costs and VII. Analysis of Environmental Impact benefits of available regulatory Implicit Price Deflator for the Gross The agency has prepared a categorical alternatives and, when regulation is Domestic Product. FDA expects that the necessary, to select regulatory proposed rule will result in a 1-year exclusion determination relying upon approaches that maximize net benefits expenditure that would exceed this the categorical exclusion at 21 CFR (including potential economic, amount. 25.30(j) and the determination that there are no extraordinary circumstances environmental, public health and safety, E. Paperwork Reduction Act of 1995 and other advantages; distributive which raise the potential for this rule to This proposed rule contains impacts; and equity). FDA has individually or cumulatively have a information collection provisions that developed a preliminary regulatory significant effect on the human are subject to review by OMB under the impact analysis (PRIA) that presents the environment (Ref. 266). FDA requests Paperwork Reduction Act of 1995 (44 benefits and costs of this proposed rule comment on its analysis and U.S.C. 3501–3520). The collections of (Ref. 265). FDA believes that the determination. As set out in more detail information in the proposed rule have proposed rule will be an economically in Section IX of this document, to the been submitted to OMB for review significant regulatory action as defined extent there are any environmental by Executive Order 12866. FDA requests under Section 3507(d) of the Paperwork effects that FDA should take into comments on the PRIA. Reduction Act of 1995. FDA invites consideration as it prepares a final rule, comments on: (1) Whether the proposed FDA requests public comment and B. Regulatory Flexibility Act collection of information is necessary supporting data or other information The Regulatory Flexibility Act for the proper performance of FDA’s (e.g., studies, data, reports). The agency requires agencies to analyze regulatory functions, including whether the will evaluate the information and input options that would minimize any information will have practical utility; received in response to this proposed significant impact of a rule on small (2) the accuracy of FDA’s estimate of the rule, including the specific questions entities. Because many small businesses burden of the proposed collection of listed in section IX of this document. will need to implement a number of information, including the validity of Although FDA finds that no EIS is new provisions, FDA acknowledges that the methodology and assumptions used; necessary for this proposed rule, if in the final rules resulting from this (3) ways to enhance the quality, utility, response to comment received, FDA proposed rule will have a significant and clarity of the information to be prepares an EA or EIS, it will provide economic impact on a substantial collected; and (4) ways to minimize the notice and an opportunity for public number of small entities. burden of the collection of information review and comment on any such on respondents, including through the document. C. Small Business Regulatory use of automated collection techniques, Enforcement Fairness Act of 1996 when appropriate, and other forms of VIII. Federalism The Small Business Regulatory information technology. FDA has analyzed this proposed rule Enforcement Fairness Act of 1996 (Pub. To ensure that comments on in accordance with the principles set L. 104–121) defines a major rule for the information collection are received, forth in Executive Order 13132. FDA purpose of congressional review as OMB recommends that written has determined that the proposed rule, having caused or being likely to cause comments be faxed to the Office of if finalized, would not contain policies one or more of the following: An annual Information and Regulatory Affairs, that would have substantial direct effect on the economy of $100 million OMB, Attn: FDA Desk Officer, FAX: effects on the States, on the relationship or more; a major increase in costs or 202–395–7285, or emailed to between the National Government and

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the States, or on the distribution of which we have not proposed specific related to the scope of applicability of power and responsibilities among the standards in proposed subparts C subpart I, proposed § 112.114 related to various levels of government. through O; and the proposed allowance dropped produce, and proposed Accordingly, the agency tentatively in § 112.12 for alternatives to certain § 112.115 related to measures to prevent concludes that the proposed rule does specified requirements, including formation of botulinum toxin; not contain policies that have appropriateness of the list of permitted specifically: federalism implications as defined in alternatives. Are there other proposed Æ Do you agree with our proposal to the Executive order and, consequently, provisions for which we should permit apply the proposed provisions in a federalism summary impact statement alternatives and, if so, under what, if subpart I when covered activities take is not required. any, additional or different criteria than place in an outdoor area or a partially- those proposed in § 112.12(b) and (c)? enclosed building where there is a IX. Comments • Proposed provisions in subparts C reasonable probability of contamination Interested persons may submit to the and D directed to personnel training, of covered produce, and our tentative Division of Dockets Management (see and health and hygiene, including the conclusion that, accordingly, crops that ADDRESSES) either electronic or written proposed requirements for training on grow completely underground would comments regarding this document. It is principles of food hygiene and food not be subject to the proposed only necessary to send one set of safety, and for the maintenance of provisions of subpart I? comments. It is no longer necessary to adequate personal cleanliness and Æ With respect to dropped produce, send two copies of mailed comments. hygienic practices when handling should proposed § 112.114 apply to all Identify comments with the docket covered produce or food-contact commodities or should we provide for number found in brackets in the surfaces during covered activities, certain exceptions (and, if so, under heading of this document. Received including the provisions relevant to use what criteria)? Does proposed § 112.114 comments may be seen in the Division of gloves and hand sanitizers; appropriately address produce (such as of Dockets Management between 9 a.m. • Proposed provisions directed to almonds) that is intentionally dropped and 4 p.m., Monday through Friday. water, including those related to water to the ground during harvesting and Comments on proposed provisions quality, microbial indicators, and testing where such harvesting does not cause and related issues—We seek comment in §§ 112.41, 112.44, and 112.45; bruising or damage to the produce? on the need for, and appropriateness of, provision related to water sourced from Should produce with peelable skin be the various provisions proposed in this public water systems in § 112.45(a); and excluded? Æ rule and our accompanying rationale. recordkeeping in § 112.50; specifically: Is proposed § 112.115 a reasonably Specifically, we seek comment on the Æ Are the provisions in §§ 112.44– necessary measure to ensure the safety following issues: 112.46 appropriately tailored to the risk of packaged covered produce? Are there • Proposed provisions in subpart A, posed by the manner in which the water specific types or conditions of modified including: is used? or reduced oxygen packaging methods Æ proposed §§ 112.1 and 112.2, Æ Are the microbial standards that may or may not increase the risk of including the produce that would be specified in these provisions formation of botulinum toxin? covered or not covered by the rule; the appropriate for the specified intended • Proposed provisions specific to list of produce that would not be uses? For example, are the microbial sprouts in subpart M, including covered by the rule because it is rarely standards appropriately tailored to uses treatment of seeds and beans; microbial consumed raw (including asparagus, such as direct application of irrigation indicators and frequency of bok choy, and cranberries); and the water? environmental monitoring; and proposed exemption for produce that Æ Are the provisions related to requirement to establish and implement receives commercial processing, treatment of water sufficiently flexible a written environmental monitoring including the types of processing that to permit alternative safe uses of water plan (§ 112.144(a)) and sampling plan should qualify for this exemption; that does not meet the specified for each production batch of sprouts Æ proposed definitions in § 112.3(c), microbial standard for its intended use? (§ 112.146(a)); as well as whether soil- including those of agricultural water, Æ Is there a need for a provision grown sprouts should be subject to the hazard, reasonably foreseeable hazard, specifically related to disinfection proposed requirements, and whether produce, humus, production batch of treatment of re-circulated or single pass and how to establish a supplier sprouts, and yard trimmings; water used during and after harvest? approval and verification program for Æ proposed definitions of small and Æ Are there any alternative options seeds and beans used for sprouting; very small businesses in § 112.3(b); as not considered in the proposed rule? • Proposed provisions in subpart N, well as the proposed exclusion of • Proposed provisions in subpart F including methods and allowance for certain farms from the scope of this rule directed to soil amendments, including alternative methods to be used provided based sales in § 112.4(a); those related to status, treatment, they are at least equivalent to the Æ whether and how we should application restrictions, minimum proposed method in accuracy, require farms that meet the criteria for application intervals, and recordkeeping precision, and sensitivity; the qualified exemption to establish and (including the requirement related to • Proposed requirements related to maintain documentation of the basis for documentation such as Certificates of documentation and records in subpart their exemption; Conformance); our focus on biological O, including the requirement for a Æ the feasibility of the labeling soil amendments of animal origin; any supervisor or responsible party to provisions in proposed 112.6(b), alternative options that we have not review certain records, and whether particularly in the case of consolidating considered in this proposed rule; and there are any circumstances that would produce from several farm locations. the risk presented by the use of warrant not applying part 11 to records • Proposed general requirements in biological soil amendments in sprouting that would be required to be kept under § 112.11, including on whether we and whether that practice should be part 112; should establish specific standards for prohibited; • Proposed provisions in subpart P any types of hazards that would be • Proposed provisions in subparts I, for variances, including related process covered in proposed § 112.11 but for K, and L, including proposed § 112.81 and scientific data and information to

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support a request for variance, and 402 of the FD&C Act. We also recognize a commodity-specific approach that circumstances for approval or denial of the need for additional standards relies on outbreak data? a request for variance and for specifically tailored to the growing, • Are there pathogen surveillance modification or revocation of an harvesting, packing and holding of data from sampling programs focusing approved variance; Are there any sprouts, and have proposed minimum on produce commodities that have no specific concerns that we should necessary standards for sprouts. We history of known outbreaks that would consider in finalizing the procedures seek comment on our tentative be useful in considering a commodity- and processes for requests for variances, conclusions related to this issue and the specific approach? as applicable to foreign governments? proposed regulatory approach described • Can commodity characteristics be • Overall implementation and in section IV of the document. In used as a basis to consider a compliance strategy and proposed addition, we seek comment on the commodity-specific approach? While provisions in subpart Q, including following: the outbreak data show no consistent specific strategies we should employ in • Are there any alternative pattern that can be matched to order to best prioritize our approaches that we should consider in commodity characteristics such as implementation of the rule, and establishing science-based minimum growth habit, our QAR shows that coordination of education and standards for the safe production and produce commodities that are ranked as enforcement activities by relevant State, harvesting of produce and to minimize higher risk of illness and those ranked Territorial, tribal, and local authorities; the risk of serious adverse health as lower risk of illness do share some of and consequences or death? the same characteristics. A further • Proposed provisions in subpart R • Are there specific commodities or refinement of our assessment might be for withdrawal of a qualified exemption, categories of commodities that should helpful in developing a commodity- including related process and be excluded from the scope of the rule, specific approach based on commodity timeframes for actions to be taken by based on data related to their relative characteristics. Considering the FDA or farms. risk considerations? (Note that under qualitative nature of our assessment, are • Regarding the scope of the our proposed integrated approach, we there quantitative data sets available recordkeeping requirements, are there propose to exempt certain commodities, that would enable a further refinement alternative options that should be including a specified list of produce that of our assessment? considered? is rarely consumed raw, and produce • We seek comment on our tentative • Regarding the handwashing and that receives commercial processing that conclusion that produce in both direct toilet facility requirements, are our adequately reduces the presence of market channels and other commercial proposals reasonably consistent with microorganisms of public health channels are subject to the same routes current model practices or are there significance; see section V.A.2.a. of this of contamination, although the number alternatives not considered in the rule.) of opportunities for contamination proposed rule? • For example, the QAR ranked during packing and holding may be Regulatory approach—As discussed certain produce commodities, such as greater for produce in other commercial in section IV of this document, we have bananas and coconuts, as lower risk for channels as compared to produce in tentatively concluded that we should illness, in part because such direct market channels if there are use a regulatory framework based on commodities are peeled or shelled greater numbers of touch points and practices, procedures, and processes before consumption in a manner that handlers in these channels than there associated with growing, harvesting, can be expected not to transfer are in direct market channels. packing, and holding of all covered contamination onto the interior, edible • We seek comment on our tentative produce. We considered and rejected portion of the commodity. Should such conclusion that because the statutory the option to develop a framework that commodities be covered by the rule? Is qualified exemption addresses market (based solely on a history of outbreaks coverage of these commodities channels as a possible risk factor, and or illnesses associated with the unnecessary? Should they be covered because we identified no data that commodity) would be applicable to but subject to a less stringent set of would allow us to otherwise use market individual commodities or classes of requirements? channels as a factor in covering and • commodities. Relevant references on the Certain commodities are ranked in regulating produce under this proposed subject of produce safety, as well as the the QAR as presenting a relatively lower rule, we should not otherwise use QAR, identify common on-farm routes likelihood of exposure, in part because market channels as a basis of risk of contamination, such as personnel such commodities have fewer potential categorization in this proposed rule. training, health, and hygiene; domestic routes of contamination and/or lower • Are other data or information and wild animals; biological soil potential for contamination. In addition, available that would be otherwise useful amendments of animal origin; some commodities are not known to in considering a commodity-specific agricultural water; and equipment and have been associated with outbreaks. approach? buildings. Procedures, processes and Some commodities (for example, pears, • We seek comment on the proposed practices in each of these on-farm routes grapefruit, oranges, and lemons) meet effective and compliance dates. of contamination have the potential to both of these criteria, considering the • We seek comment on the introduce biological hazards into or rankings and outbreak data used in the appropriateness of the proposed onto any covered produce. Therefore, QAR. Should commodities that meet exemptions and partial exemptions. Are we are proposing an integrated both of these criteria be covered by the there additional exemptions and approach to prescribe standards for each rule? Is coverage of these commodities relevant data to support such of these on-farm routes of contamination unnecessary? Should they be covered exemptions that we should consider? that we have tentatively determined are but subject to a less stringent set of Qualitative assessment of risk—We reasonably necessary to prevent the requirements? How should the rule seek comment on the QAR, conclusions introduction of known or reasonably address the changing nature of outbreak drawn from that assessment, and our foreseeable biological hazards and to data over time? consideration of those conclusions in provide reasonable assurances that • How should we account for developing the proposed requirements produce is not adulterated under section uncovered commodities in considering described in this rule. We also request

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you to submit any data or factual evidence associating listeriosis with nor an accumulation of statewide information that may help the agency to produce, especially with intact fruits databases, that would enable us to conduct, as warranted, a thorough and and vegetables (Ref. 268. Ref. 269. Ref. identify the names and locations of all robust quantitative assessment of risk 270. Ref. 271. Ref. 272. Ref. 267). entities subject to this proposed associated with produce production and However, this recent outbreak indicates regulation. This would enable us to harvesting practices. that intact produce can be a vehicle for better provide outreach and technical Chemical, physical or radiological listeriosis. What is not known is the assistance to covered entities. In hazards—We seek comment on our extent to which, and under what addition, while inspection is intended tentative conclusion that procedures, circumstances, whole produce to be only a relatively minor part of our practices, and processes, which are contaminated with L. monocytogenes overall compliance effort (see section proposed in this rule, are reasonably presents a risk to consumers. The V.Q. of the document for more necessary to prevent the introduction of outbreak of listeriosis due to information on our overall strategy), we biological hazards only, and on contamination of intact cantaloupes anticipate performing inspections for whether, and to what extent, chemical, appears to have occurred due to a enforcement purposes. We would use physical or radiological hazards should combination of factors, including the covered farm registration be covered within the scope of a final pooled water on the floor of the facility, information to create a database that we rule. Are there procedures, practices, or which was also difficult to clean, poorly would use to allocate inspection processes that minimize the risk of designed equipment that was previously resources. We are also interested in the serious adverse health consequences or used for other commodities, no pre-cool existence of databases that could help death and that are reasonably necessary step, a truck parked near the packing us identify covered farms in the absence to prevent the introduction of known or area that had visited a cattle operation, of a registration system, and in the reasonably foreseeable chemical, and possible low level contamination appropriate data elements that should physical or radiological hazards into from the growing/harvesting operation be collected in a registration system, produce or to provide reasonable (Ref. 273). The contribution of should we decide to set up such a assurances that produce is not internalization of the organism and system. adulterated under section 402 of the growth within the fruit is not known. Environmental issues—Consistent FD&C Act? Moreover, it is not known whether all with § 25.50, FDA is involving the Environmental testing for L. of these circumstances are needed for L. public in implementing its NEPA monocytogenes or Listeria spp for monocytogenes to present a risk on procedures applicable to this proposed covered produce other than sprouts— produce or whether any one or more rule. The agency will evaluate the Proposed § 112.143(a) would require would have been sufficient. We also do information and input received in testing the growing, harvesting, packing, not know the prevalence of L. response to this proposed rule, and holding environment for sprouts for monocytogenes environmental including the specific questions below, Listeria species or L. monocytogenes; contamination of fruit and vegetable to determine further actions, as however, we have not proposed to packing facilities (both on- and off- appropriate. require environmental testing for other farm), nor do we know the prevalence Proposed subpart E would establish covered produce. A recent outbreak of of L. monocytogenes on produce standards for an indicator organism in listeriosis from cantaloupes attributed to washed, packed, cooled and stored in agricultural water applied to covered insanitary conditions at a facility that such facilities. We encourage research to produce, and establish requirements for washed, packed, cooled and held intact answer these questions. We request waters that do not meet those standards. cantaloupes (Ref. 267) raises the comment on whether we should require, We are soliciting comments on potential question as to whether specific in a final rule, any or all covered farms means or mechanisms for meeting the measures are necessary to minimize the that wash and pack produce, or that proposed standards. In your responses, risk posed by L. monocytogenes as an only pack produce, to perform please distinguish, to the extent environmental pathogen. As discussed environmental testing for L. appropriate, between sprouts and other in section V.A. of this document, this monocytogenes or Listeria spp., and any covered produce. proposed rule would not apply to off- criteria that should be employed to 1. Do farms that would be covered by farm facilities such as the facility determine which farms should be the proposed rule, if finalized, currently associated with this cantaloupe subjected to such a requirement. treat water used for irrigation directly outbreak— such facilities would instead Operational assessment, food safety applied to covered produce other than be subject to part 110 and may be plans—As discussed in section IV of sprouts, or water used to irrigate sprouts subject to section 418 of the FD&C Act. this document, while we recommend (whether or not it is directly applied)? However, the same risk factors and that farms conduct an operational We are seeking comments on pesticides potential measures for minimizing risk assessment and develop a food safety used to reduce concentration of are relevant to both on-farm and off- plan, at this time, we are not proposing organisms of concern in water used for farm produce washing, packing, cooling, to require them to do so. We request such irrigation and not pesticides used and holding practices. Such measures comment on whether we should require, to prevent biofouling (chemigation). could include environmental testing for in a final rule, some or all covered farms 2. What actions are currently being L. monocytogenes or Listeria spp. to to perform operational assessments and/ taken by farmers, either on their own or verify the adequacy of a covered farm’s or develop a food safety plan, and any at the request of produce handlers or sanitation measures. Because L. criteria that should be employed to sellers to control the bacterial loads in monocytogenes is a ubiquitous determine which farms should be water? Please provide data to support microorganism, an intact fruit or subjected to such a requirement. the information provided. vegetable could reasonably be expected Registration—We are also requesting 3. What water treatment methods do to occasionally be positive for L. comment about whether we should farmers use to clean their irrigation monocytogenes. Many studies have require, in a final rule, that covered systems, how broadly are they used, and shown the presence of L. farms, as described in proposed what are the effects on the environment? monocytogenes on fresh, intact produce, § 112.4(a), register with FDA. We are not In what amounts or frequency are each but there is limited epidemiological aware of a nationwide database of farms, of these methods applied? Please

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provide data to support the information alternative to composting that would construction of fences or other physical provided. not require use of an application barriers, chemical deterrents, or other 4. Do farms currently use municipal interval. We are also soliciting mechanisms around growing areas to water sources to irrigate produce that comments on available chemical exclude wildlife? Please provide data or would be covered by this proposed rule, treatment methods. other information to support the if finalized? If so, please provide data on 1. Do farms that would be covered by information provided. the use rate and prevalence of this the proposed rule, if finalized, currently 4. Has the implementation of practice, as well as data regarding utilize chemical treatments to prevent or measures to prevent animal intrusion effects on crop productivity of minimize pathogens in manure? negatively impacted habitat for rare or disinfection byproducts in municipal 2. What types and quantities of declining aquatic or terrestrial wildlife water used to irrigate produce that chemicals are used for chemical species or migratory birds? Please would be covered by the rule. treatment of manure? Please describe provide examples. 5. What sources of irrigation water the treatment protocols, including (for example, municipal water, surface application time, containment methods, X. References water and groundwater) are most and temperature requirements. The following references have been frequently used? If more than one 3. Please provide any data or other placed on display in the Division of source is available, is there a preference information relating to the effectiveness, Dockets Management (see ADDRESSES) for using one source over another? and the relative effectiveness, of these and may be seen by interested persons Please explain why. chemical manure treatments, as well as between 9 a.m. and 4 p.m., Monday In addition, we seek comment on any environmental effects of their use. through Friday. (FDA has verified the potential effects of actions taken as a Proposed subpart I would apply when Web site addresses, but FDA is not result of this rule on water rights/Tribal under the circumstances there is a responsible for any subsequent changes rights. Are water rights or Tribal rights reasonable probability that animal to the Web sites after this document likely to be affected by actions taken as intrusion will contaminate covered publishes in the Federal Register.) a result of this rule? If so, how and to produce. In such circumstances, proposed subpart I would require 1. U.S. Department of Health and Human what extent? Services and U.S. Department of Proposed subpart F would require the monitoring of those areas that are used Agriculture. Dietary Guidelines for use of application method restrictions, for a covered activity for evidence of Americans, 2010. 2011. www.health.gov/ application intervals, and/or treatment animal intrusion immediately prior to DietaryGuidelines/dga2010/ of biological soil amendments of animal harvest and as needed during the DietaryGuidelines2010.pdf. origin to reduce exposure of covered growing season. If significant evidence 2. Food and Drug Administration. s.v. ‘‘Draft produce to organisms of public health of animal intrusion is found, these Qualitative Assessment of Risk to Public provisions would require farms to Health from On-Farm Contamination of concern. We recognize that the Produce.’’ Accessed 2012. requirements in this section may evaluate whether the covered produce can be harvested in accordance with 3. D’Lima, C., Vierk, K., and Food and Drug represent a departure from current Administration, ‘‘Memorandum to the practices. proposed subpart K. Proposed subpart K Record’’, 2011. 1. How do farms that would be would require taking reasonable 4. Smith, M. A. s.v. ‘‘Memorandum to the covered by the proposed rule, if measures to identify, and not harvest, Record.’’ Accessed 2012. finalized, currently manage solid animal covered produce that is reasonably 5. Viazis, S. and Food and Drug waste? Manage liquid animal waste? likely to be contaminated, including Administration, ‘‘Memorandum to the 2. What is the prevalence of steps to identify and not harvest covered Record’’, 2011. composting on farms using methods produce that is visibly contaminated 6. Centers for Disease Control and described in proposed subpart F? Please with animal excreta. We are soliciting Prevention. ‘‘Multistate Outbreaks of comments on current practices relevant Salmonella Infections Associated with provide data or other available Raw Tomatoes Eaten in Restaurants— information on the frequency of such to these provisions. United States, 2005–2006.’’ MMWR 56, composting. 1. What measures, if any, are no. 35 (2007): 909–911. 3. Are composting methods other than currently being implemented to prevent 7. Beru, N. and Food and Drug those described in proposed subpart F harvest of produce contaminated by Administration. s.v. ‘‘Memorandum to currently utilized on farms? To what excreta deposited by wild animals? If the Record.’’ Accessed 2012. extent? Please provide data or other there are preferred measures, please 8. ‘‘Enforcement Reports.’’ Food and Drug available information on the frequency explain the rationale for such Administration. http://www.fda.gov/ of such composting. preference. Please provide data to Safety/Recalls/EnforcementReports/ 4. Are currently utilized methods of support the information provided. default.htm. Last Modified 2011. composting governed by state, county or 2. Are farms removing vegetation 9. ‘‘Sources of Ionizing Radiation.’’ United bordering outdoor produce growing Nations Scientific Committee on the local laws, ordinances or regulations? Effects of Atomic Radiation. UNSCEAR Please identify in your comments any areas or drainages in an effort to deter 2008 Report. http://www.unscear.org/ relevant laws, ordinances, or wildlife from entering growing areas? If unscear/en/publications/2008_1.html. regulations, and include copies if so, what is the current rate at which Last Modified 2011. reasonably feasible. vegetation bordering outdoor produce 10. ‘‘Guidance for Industry: Guide to 5. What are the current laws, growing areas or drainages is currently Minimize Microbial Food Safety Hazards ordinances, or regulations in produce being removed? Are sediment basins or for Fresh Fruits and Vegetables.’’ Food growing areas that govern manure other conservation practices currently and Drug Administration. http:// handling and storage? How if at all do being removed and at what rate? Please www.fda.gov/food/ such laws, ordinances, or regulations provide data or other information to guidancecomplianceregulatory information/guidancedocuments/ address potential environmental effects support the information provided. produceandplanproducts/ from methane associated with manure? 3. To what extent have farmers taken ucm064458.htm. Accessed November 30, Ammonia? Nitrogen? Phosphorus? action to exclude wildlife from outdoor 2011. Last Modified 1998. Under proposed subpart F, manure produce growing areas? What measures 11. ‘‘Letter to Firms that Grow, Pack, or Ship may be chemically treated as an are being used for these purposes, e.g. Fresh Lettuce and Fresh Tomatoes.’’

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Association of Food and Drug Officials Consumer Protection Policy.’’ Noland, J. 12. ‘‘Letter to California Firms that Grow, Model Code for Produce Safety for State and Kunduru, M. http:// Pack, Process, or Ship Fresh and Fresh- and Local Regulatory Agencies. suppliers.safeway.com/usa/forms/ cut Lettuce, November 4, 2005.’’ Food Association of Food and Drug Officials, Produce_Vendor_Food_ and Drug Administration. http:// 2009. Safety_Verification_Program.pdf. www.fda.gov/Food/FoodSafety/Product- 21. Crawford, W., Baloch, M., and Gerrity, K. Accessed December 9, 2011. Last SpecificInformation/ Environmental Assessment Report, FDA Modified 2008. FruitsVegetablesJuices/ Foods Program, Non-O157 Shiga Toxin- 31. ‘‘California Leafy Green Products GuidanceComplianceRegulatory Producing E. coli (STEC). 2010. http:// Handlers Marketing Agreement.’’ Information/ucm118911.htm. Accessed www.fda.gov/downloads/Food/ California Department of Food and December 8, 2011. Last Modified 2011. 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Codex Alimentarius Commission. s.v. Public Health to Sprout Manufacturers.’’ Content_Level_Pages/Issue_Briefs/ ‘‘Hazard Analysis and Critical Control Pettit, J. M. and California Department of PSP_PEW-PSP-Composting-Manure- Point (HACCP) System and Guidelines Public Health. http://www.fda.gov/ Narrative-v4-2.pdf. Accessed 5–25–2012. for Its Application.’’ Accessed 2003. NewsEvents/PublicHealthFocus/ 28. Lowell, K., Langholz, J., and Stuart, D. www.codexalimentarius.net/download/ ucm152150.htm. Last Modified 2009. Safe and Sustainable: Co-Managing for standards/23/CXP_001e.pdf. 19. ‘‘Produce Safety From Production to Food Safety and Ecological Health in 41. ‘‘Hazard Analysis and Critical Control Consumption: A Proposed Action Plan to California’s Central Coast Region. 2010. 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of Food Protection 66, no. 1 (2003): 82– 242. ‘‘Proposal P1004, Primary Production & 254. ‘‘Listeria Guidelines for Industry.’’ 87. Processing Standard for Seed Sprouts, U.S.Department of Agriculture and Food 228. Duffy, E. A., Lucia, L. M., Kells, J. M. Approval Report.’’ Food Standards Safety and Inspection Service. http:// et al. ‘‘Concentrations of Escherichia coli Australia New Zealand. http:// www.fsis.usda.gov/OA/topics/ and Genetic Diversity and Antibiotic www.foodstandards.gov.au/_srcfiles/ lmguide.htm. Last Modified 1999. Resistance Profiling of Salmonella P1004%20PPPS%20for%20Sprouts%20 255. Fu, T., Stewart, D., Reineke, K. et al. Isolated from Irrigation Water, Packing AppR.pdf. Accessed December 22, 2011. ‘‘Use of Spent Irrigation Water for Shed Equipment, and Fresh Produce in Last Modified 2011. Microbiological Analysis of Alfalfa Texas.’’ Journal of Food Protection 68, 243. Fett, W. F., Tortorell, M., and Fu, T. 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Moore, C. M., Sheldon, B. W., and fssa/frefra/safsal/sprointe.shtml. Last 259. Tompkin, R. B. ‘‘Control of Listeria Jaykus, L.-A. ‘‘Transfer of Salmonella Modified 2008. monocytogenes in the food-processing and Campylobacter from Stainless Steel 246. ‘‘Transcript of Proceedings of Public environment.’’ Journal of Food to Romaine Lettuce.’’ Journal of Food Meeting on Sprout Safety, May 17, Protection 65, no. 4 (2002): 709–725. Protection 66, no. 12 (2003): 2231–2236. 2005.’’ http://www.fda.gov/Food/ 260. ‘‘Guidance for Industry: Control of 233. Carrington, E. G. Evaluation of Sludge FoodSafety/Product- Listeria monocytogenes in Refrigerated Treatments for Pathogen Reduction— SpecificInformation/ for Frozen Ready-To-Eat Foods; Draft Final Report. 2001. FruitsVegetablesJuices/ucm078701.htm. Guidance.’’ Food and Drug 234. Bihn, E. A. and Gravani, R. B. ‘‘Role of Last Modified 2010. Administration. http://www.fda.gov/ Good Agricultural Practices in Fruit and 247. Steinmuller, N., Demma, L., Bender, J. Food/GuidanceComplianceRegulatory Vegetable Safety.’’ In Microbiology of B. et al. ‘‘Outbreak of Enteric Disease Information/GuidanceDocuments/Food Fresh Produce, edited by Matthews, K. Associated with Animal Contact: Not ProcessingHACCP/ucm073110.htm. R., 21–52. Washington, DC: ASM Press, Just a Foodborne Problem Anymore.’’ Accessed December 28, 2011. Last 2006. Modified 2008. 235. ‘‘Investigation of the Taco John’s Clinical Infectious Diseases 43, (2006): Escherichia coli O157:H7 Outbreak 1596–1602. 261. ‘‘Instruction Recordkeeping (NOP Associated with Iceberg Lettuce, Final 248. Winthrop, K. L., Palumbo, M. S., Farrar, 2602).’’ United States Department of Report.’’ California Food Emergency J. A. et al. ‘‘Alfalfa Sprouts and Agriculture. http://www.ams.usda.gov/ Response Team. http:// Salmonella Kottbus Infection: A AMSv1.0/getfile?dDocName= www.cdph.ca.gov/pubsforms/ Multistate Outbreak following STELPRDC5087110. Last Modified 2012. Documents/fdb%20eru%20IceLet%20 Inadequate Seed Disinfection with Heat 262. Florida Department of Agriculture and TacoJohn022008.pdf. Last Modified and Chlorine.’’ Journal of Food Consumer Services. Tomato Best 2008. Protection 66, no. 1 (2003): 13–17. Practices Manual. Florida Department of 236. ‘‘The Fecal Bacteria.’’ Sadowsky, M. J. 249. Gill, C. J., Keene, W. E., Mohle-Boetani, Agriculture and Consumer Services, and Whitman, R. L. American Society for J. C. et al. ‘‘Alfalfa Seed Decontamination 2007. http://www.freshfromflorida.com/ Microbiology. http://www.knovel.com/ in Salmonella Outbreak.’’ Emerging fs/TomatoBestPractices.pdf. Accessed web/portal/browse/display?_EXT_ Infectious Diseases 9, no. 4 (2003): 474– 11–29–2011. KNOVEL_DISPLAY_bookid=4177. 479. 263. ‘‘LGMA, California Leafy Green Accessed December 1, 2011. Last 250. Brooks, J. T., Rowe, S. Y., Shillam, P. et Products.’’ www.caleafygreens.ca.gov./ Modified 2011. al. ‘‘Salmonella Typhimurium Infections Accessed February 23, 2012. Last 237. Institute for Food Safety and Health and Transmitted by Chlorine-pretreated Modified 2012. Sprout Safety Task Force. s.v. ‘‘Sprout Clover Sprout Seeds.’’ American Journal 264. ‘‘Prepare.’’ Merriam-Webster Online. Safety Training Workshop.’’ Accessed of Epidemiology 154, no. 11 (2001): Dictionary and Thesaurus—Merriam- 2011. 1020–1028. Webster Online. www.merriam- 238. Food and Drug Administration. s.v. 251. Montville, R. and Schaffner, D. ‘‘Monte webster.com/dictionary/prepare. ‘‘HHS News, Consumers Advised of Carlo Simulation of Pathogen Behavior Accessed February 26, 2012. Last Risks Associated with Raw Sprouts.’’ during the Sprout Production Process.’’ Modified 2012. Accessed 1999. Applied and Environmental 265. ‘‘Fda’s analysis to examine the impacts 239. Food and Drug Administration. s.v. Microbiology 71, no. 2 (2005): 746–753. of the Produce Safety proposed rule ‘‘Consumers Advised of Risks Associated 10.1128/?AEM.71.2.746–753.2005. under Executive Order 12866, Executive with Eating Raw and Lightly Cooked 252. ‘‘Recall—Firm Press Release, Order 13563, the Regulatory Flexibility Sprouts.’’ Accessed 2002. Amalgamated Produce, Inc. Recalls Act (5 U.S.C. 601–612), the Unfunded 240. Food Safety Authority of Ireland. s.v. Sprouts in the North Eastern United Mandates Reform Act of 1995 (Public ‘‘Guidelines on Safe Production of States Because of Possible Health Risks.’’ Law 104–4), and the Paperwork Ready-to-Eat Sprouted Seeds (Sprouts).’’ Food and Drug Administration. http:// Reduction Act of 1995 (44 U.S.C. 3501– Accessed 2011. www.fda.gov/Safety/Recalls/ 3520)’’. 241. California Department of Health ArchiveRecalls/2009/ucm135947.htm. 266. Proffitt, L. D. and McCarthy, A. M. s.v. Services and Food and Drug Accessed December 23, 2011. Last ‘‘Memorandum to the Record.’’ Accessed Administration. s.v. ‘‘Safer Processing of Modified 2009. 2012. Sprouts.’’ Accessed 2000. http:// 253. Food and Drug Administration. s.v. 267. ‘‘Multistate Outbreak of Listeriosis www.cdph.ca.gov/pubsforms/ ‘‘Recalls: Listeria monocytogenes in Linked to Whole Cantaloupes from Documents/fdbIRfrm01.pdf. Sprouts.’’ Accessed 2011. Jensen Farms, Colorado.’’ Centers for

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Disease Control and Prevention. http:// The additions read as follows: covered produce and food-contact www.cdc.gov/listeria/outbreaks/ surfaces with microorganisms of public cantaloupes-jensen-farms/. Accessed § 16.1 Scope. health significance? December 28, 2011. Last Modified 2011. * * * * * Subpart E—Standards Directed to 268. Norton, D. M. and Braden, C. R. (b) * * * Agricultural Water ‘‘Foodborne Listeriosis.’’ In Listeria, (1) * * * Listeriosis, and Food Safety, edited by Section 419(c)(2)(D) of the Federal 112.41 What requirements apply to the quality of agricultural water? Ryser, Elliot T and Marth, Elmer H., CRC Food, Drug, and Cosmetic Act relating Press, 2007. 112.42 What measures must I take with 269. Schlech, W. F., Lavigne, P. M., to the modification or revocation of a respect to my agricultural water sources, Bortolussi, R. A. et al. ‘‘Epidemic variance from the requirements of water distribution system, and pooling of Listeriosis—Evidence for Transmission section 419 of the Federal Food, Drug, water? by Food.’’ New England Journal of and Cosmetic Act (see part 112, subpart 112.43 What treatment of agricultural water Medicine 308, no. 4 (1983): 203–206. P of this chapter). is required, and what requirements apply to treating agricultural water? 270. Ho, J. L., Shands, K. N., Friedland, G. * * * * * et al. ‘‘An outbreak of type 4b Listeria 112.44 What testing is required for (2) * * * agricultural water, and what must I do monocytogenes infection involving §§ 112.201 through 112.211, (part 112, patients from eight Boston hospitals.’’ based on the test results? Archives of Internal Medicine 146, no. 3 subpart R), relating to withdrawal of a 112.45 How often must I test agricultural (1986): 520–524. qualified exemption. water that is subject to requirements of 271. ‘‘FDA Lab Results Positive for Listeria at * * * * * § 112.44? SanGar Fresh Cut Produce.’’ Food and ■ 3. Add part 112 to read as follows: 112.46 What measures must I take for water Drug Administration. http:// that I use during harvest, packing, and www.fda.gov/Food/FoodSafety/Product- PART 112—STANDARDS FOR THE holding activities for covered produce? SpecificInformation/ 112.50 Under this subpart, what GROWING, HARVESTING, PACKING, requirements apply regarding records? FruitsVegetablesJuices/ucm232237.htm. AND HOLDING OF PRODUCE FOR Accessed December 28, 2011. Last HUMAN CONSUMPTION Subpart F—Standards Directed to Modified 2010. Biological Soil Amendments of Animal 272. ‘‘Investigation of an Outbreak of Subpart A—General Provisions Origin and Human Waste Salmonella Saintpaul Infections Linked to Raw Alfalfa Sprouts.’’ Centers for Sec. 112.51 What requirements apply for determining the status of a biological soil Disease Control and Prevention. http:// 112.1 What food is covered by this part? amendment of animal origin? www.cdc.gov/salmonella/saintpaul/ 112.2 What produce is not covered by this 112.52 How must I handle, convey, and alfalfa/archive/042709.html. Accessed part? store biological soil amendments of December 28, 2011. Last Modified 2009. 112.3 What definitions apply to this part? animal origin? 273. ‘‘Information on the Recalled Jensen 112.4 Who is subject to the requirements of 112.53 What prohibitions apply regarding Farms Whole Cantaloupes.’’ Food and this part? use of human waste? Drug Administration. http:// 112.5 Who is eligible for a qualified exemption and associated modified 112.54 What treatment processes are www.fda.gov/Food/FoodSafety/ acceptable for a biological soil CORENetwork/ucm272372.htm#report. requirements based on average monetary value of all food sold and direct farm amendment of animal origin that I apply Last Modified 2011. marketing? in the growing of covered produce? List of Subjects 112.6 What modified requirements apply to 112.55 What microbial standards apply to me if I am eligible for a qualified the treatment processes in § 112.54? 21 CFR Part 16 exemption in accordance with § 112.5? 112.56 What application requirements and minimum application intervals apply to Administrative practice and Subpart B—General Requirements biological soil amendments of animal procedure. 112.11 What general requirements apply to origin? 21 CFR Part 112 persons who are subject to this part? 112.60 Under this subpart, what 112.12 Are there any alternatives to the requirements apply regarding records? Foods, Fruits and vegetables, requirements established in this part? Incorporation by reference, Packaging Subpart G—[Reserved] and containers, Recordkeeping Subpart C—Standards Directed to Subpart H—[Reserved] Personnel Qualifications and Training requirements, Safety. Subpart I—Standards Directed to 112.21 What requirements apply regarding Therefore, under the Federal Food, Domesticated and Wild Animals Drug, and Cosmetic Act and under qualifications and training for personnel who handle (contact) covered produce or 112.81 How do the requirements of this authority delegated to the Commissioner food-contact surfaces? subpart apply to areas where covered of Food and Drugs, it is proposed that 112.22 What minimum requirements apply activities take place? 21 CFR Chapter I be amended to read as for training personnel who conduct a 112.82 What requirements apply regarding follows: covered activity? domesticated animals that I allow to 112.23 What requirements apply regarding graze in fields or use as working animals PART 16—REGULATORY HEARING supervisors? where I grow covered produce? BEFORE THE FOOD AND DRUG 112.30 Under this subpart, what 112.83 What requirements apply regarding ADMINISTRATION requirements apply regarding records? animal intrusion? Subpart J—[Reserved] ■ Subpart D—Standards Directed to Health 1. The authority citation for 21 CFR and Hygiene part 16 continues to read as follows: Subpart K—Standards Directed to Growing, 112.31 What measures must I take to Harvesting, Packing, and Holding Activities Authority: 15 U.S.C. 1451–1461; 21 U.S.C. prevent ill or infected persons from 112.111 What measures must I take if I 141–149, 321–394, 467f, 679, 821, 1034; 28 contaminating covered produce with grow, harvest, pack or hold both covered U.S.C. 2112; 42 U.S.C. 201–262, 263b, 364. microorganisms of public health and excluded produce? ■ 2. In § 16.1: significance? 112.112 What measures must I take during ■ a. In paragraph (b)(1), add an entry in 112.32 What hygienic practices must harvest activities? numerical order. personnel use? 112.113 How must I handle harvested ■ b. In paragraph (b)(2), add an entry in 112.33 What measures must I take to covered produce during covered numerical order. prevent visitors from contaminating activities?

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112.114 What requirements apply to species or L. monocytogenes to satisfy 112.204 What must I do if I receive an order dropped covered produce? the requirements of § 112.143(a) and to withdraw a qualified exemption 112.115 What measures must I take when § 112.144? applicable to my farm? packaging covered produce? Subpart O—Requirements Applying to 112.205 Can I appeal or request a hearing 112.116 What measures must I take when on an order to withdraw a qualified using food-packing (including food Records That You Must Establish and Keep exemption applicable to my farm? packaging) material? 112.161 What general requirements apply 112.206 What is the procedure for to records required under this part? Subpart L—Standards Directed to submitting an appeal? Equipment, Tools, Buildings, and Sanitation 112.162 Where must I store records? 112.163 May I use existing records to satisfy 112.207 What is the procedure for 112.121 What equipment and tools are the requirements of this part? requesting an informal hearing? subject to the requirements of this 112.164 How long must I keep records? 112.208 What requirements are applicable subpart? 112.165 What formats are acceptable for the to an informal hearing? 112.122 What buildings are subject to the records I keep? 112.209 Who is the presiding officer for an requirements of this subpart? 112.166 What requirements apply for appeal and for an informal hearing? 112.123 What requirements apply regarding making records available and accessible equipment and tools subject to this 112.210 What is the timeframe for issuing a to FDA? subpart? decision on an appeal? 112.124 What requirements apply to 112.167 Can records that I provide to FDA 112.211 When is an order to withdraw a instruments and controls used to be disclosed to persons outside of FDA? qualified exemption applicable to a farm measure, regulate, or record? Subpart P—Variances revoked? 112.125 What requirements apply to Authority: 21 U.S.C. 321, 331, 342, 350h, equipment that is subject to this subpart 112.171 Who may request a variance from used in the transport of covered the requirements of this part? 371; 42 U.S.C. 243, 264, 271. produce? 112.172 How may a State or foreign country 112.126 What requirements apply to my request a variance from one or more Subpart A—General Provisions buildings? requirements of this part? 112.127 What requirements apply regarding 112.173 What must be included in the § 112.1 What food is covered by this part? domesticated animals in and around a Statement of Grounds in a petition requesting a variance? (a) Unless it is excluded from this part fully-enclosed building? under § 112.2, food that is produce 112.128 What requirements apply regarding 112.174 What data and information pest control in buildings? submitted in a petition requesting a within the meaning of this part and that 112.129 What requirements apply to toilet variance are publicly available? is a raw agricultural commodity (RAC) facilities? 112.175 Who responds to a petition is covered by this part. This includes a 112.130 What requirements apply for hand- requesting a variance? produce RAC that is grown domestically washing facilities? 112.176 What process applies to a petition and a produce RAC that will be 112.131 What must I do to control and requesting a variance? imported or offered for import in any dispose of sewage? 112.177 Can an approved variance apply to State or territory of the United States, 112.132 What must I do to control and any person other than those identified in the District of Columbia, or the dispose of trash, litter, and waste in areas the petition requesting that variance? used for covered activities? 112.178 Under what circumstances may Commonwealth of Puerto Rico. 112.133 What requirements apply to FDA deny a petition requesting a (b) For the purpose of this part and plumbing? variance? subject to the exemptions and qualified 112.134 What must I do to control animal 112.179 When does a variance approved by exemptions therein, covered produce excreta and litter from domesticated FDA become effective? includes all of the following: animals that are under my control? 112.180 Under what circumstances may 112.140 Under this subpart, what FDA modify or revoke an approved (1) Fruits and vegetables such as requirements apply regarding records? variance? almonds, apples, apricots, aprium, asian Subpart M—Standards Directed to Sprouts 112.181 What procedures apply if FDA pear, avocados, babaco, bamboo shoots, 112.141 What requirements apply to seeds determines that an approved variance bananas, Belgian endive, blackberries, or beans used to grow sprouts? should be modified or revoked? blueberries, broccoli, cabbage, 112.142 What measures must I take for 112.182 What are the permissible types of cantaloupe, carambola, carrots, growing, harvesting, packing, and variances that may be granted? cauliflower, celery, cherries, citrus holding sprouts? Subpart Q—Compliance and Enforcement (such as clementine, grapefruit, lemons, 112.143 What testing must I do during 112.191 How do the criteria and definitions limes, mandarin, oranges, tangerines, growing, harvesting, packing, and tangors, and uniq fruit), cucumbers, holding sprouts? in this part apply to the Federal Food, 112.144 What requirements apply to testing Drug, and Cosmetic Act and the Public curly endive, garlic, grapes, green beans, the environment for Listeria species or L. Health Service Act? guava, herbs (such as basil, chives, monocytogenes? 112.192 What is the result of a failure to cilantro, mint, oregano, and parsley), 112.145 What actions must I take if the comply with this part? honeydew, kiwifruit, lettuce, mangos, growing, harvesting, packing, or holding 112.193 What are the provisions for other melons (such as canary, crenshaw environment tests positive for Listeria coordination of education and and persian), mushrooms, nectarine, enforcement? species or L. monocytogenes? onions, papaya, passion fruit, peaches, 112.146 What must I do to collect and test Subpart R—Withdrawal of Qualified pears, peas, peppers (such as bell and samples of spent sprout irrigation water Exemption or sprouts? hot), pineapple, plums, plumcot, radish, 112.150 Under this subpart, what 112.201 Under what circumstances can raspberries, red currant, scallions, snow requirements apply regarding records? FDA withdraw a qualified exemption in peas, spinach, sprouts (such as alfalfa accordance with the requirements of and mung bean), strawberries, summer Subpart N—Analytical Methods § 112.5? squash (such as patty pan, yellow and 112.151 What methods must I use to test 112.202 What procedure will FDA use to zucchini), tomatoes, walnuts, the quality of water to satisfy the withdraw an exemption? watercress, and watermelon; and requirements of § 112.45? 112.203 What information must FDA 112.152 What methods must I use to test include in an order to withdraw a (2) Mixes of intact fruits and the growing environment for Listeria qualified exemption? vegetables (such as fruit baskets).

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§ 112.2 What produce is not covered by small business if it is subject to this part materials such as humus, manure, non- this part? and, on a rolling basis, the average fecal animal byproducts, peat moss, pre- (a) The following produce is not annual monetary value of food (as consumer vegetative waste, sewage covered by this part: defined in paragraph (c) of this section) sludge biosolids, table waste, (1) Produce that is rarely consumed you sold during the previous 3-year agricultural tea, or yard trimmings, raw, specifically the produce on the period is no more than $250,000. alone or in combination. following exhaustive list—arrowhead, (2) Small business. For the purpose of Biological soil amendment of animal arrowroot, artichokes, asparagus, beets, this part, your farm is a small business origin means a biological soil black-eyed peas, bok choy, brussels if it is subject to this part and, on a amendment which consists, in whole or sprouts, chick-peas, collard greens, rolling basis, the average annual in part, of materials of animal origin, crabapples, cranberries, eggplant, figs, monetary value of food (as defined in such as manure or non-fecal animal ginger root, kale, kidney beans, lentils, paragraph (c) of this section) you sold byproducts, or table waste, alone or in lima beans, okra, parsnips, peanuts, during the previous 3-year period is no combination. The term ‘‘biological soil pinto beans, plantains, potatoes, more than $500,000; and your farm is amendment of animal origin’’ does not pumpkin, rhubarb, rutabaga, sugarbeet, not a very small business as provided in include any form of human waste. sweet corn, sweet potatoes, taro, paragraph (b)(1) of this section. Composting means a process to turnips, water chestnuts, winter squash (c) For the purpose of this part, the produce humus in which organic (acorn and butternut squash), and yams; following definitions also apply: material is decomposed by the actions (2) Produce that is produced by an Adequate means that which is needed of microorganisms under thermophilic individual for personal consumption or to accomplish the intended purpose in conditions for a designated period of produced for consumption on the farm keeping with good public health time (for example, 3 days) at a or another farm under the same practice. designated temperature (for example, ownership; and Adequately reduce microorganisms of 131°F (55 °C)), followed by a curing (3) Produce that is not a raw public health significance means reduce stage under cooler conditions. agricultural commodity. the presence of such microorganisms to Covered activity means growing, (b) Covered produce is eligible for an extent sufficient to prevent illness. harvesting, packing, or holding covered Agricultural tea means a water extract exemption from the requirements of this produce, provided that all covered of biological materials (such as humus, part (except as noted in paragraphs produce used in covered packing or manure, non-fecal animal byproducts, (b)(1), (b)(2), and (b)(3) of this section) holding activities is grown, raised, or peat moss, pre-consumer vegetative under the following conditions: consumed on that farm or another farm waste, table waste, or yard trimmings), (1) The covered produce receives under the same ownership. Covered excluding any form of human waste, commercial processing that adequately activity does not include produced to transfer microbial biomass, reduces the presence of microorganisms manufacturing/processing within the fine particulate organic matter, and of public health significance. Examples meaning defined in this chapter. This soluble chemical components into an of commercial processing that part does not apply to activities of a aqueous phase. Agricultural teas are adequately reduces the presence of facility that are subject to part 110 of held for longer than one hour before microorganisms of public health this chapter. significance are processing in application. Covered produce means produce that accordance with the requirements of Agricultural tea additive means a is subject to the requirements of this parts 113, 114, or 120 of this chapter, nutrient source (such as molasses, yeast part in accordance with §§ 112.1 and treating with a validated process to extract, or algal powder) added to 112.2. The term ‘‘covered produce’’ eliminate spore-forming microorganisms agricultural tea to increase microbial refers to the harvestable or harvested (such as processing to produce tomato biomass. part of the crop. paste or shelf-stable tomatoes), and Agricultural water means water used Curing means the maturation stage of processing such as refining or distilling in covered activities on covered produce composting, which is conducted after produce into products such as sugar, oil, where water is intended to, or is likely much of the readily metabolized spirits, or similar products; to, contact covered produce or food- biological material has been (2) You must establish and keep contact surfaces, including water used decomposed, at cooler temperatures documentation in accordance with the in growing activities (including than those in the thermophilic phase of requirements of subpart O of this part, irrigation water applied using direct composting, to further reduce of the identity of the recipient of the water application methods, water used pathogens, promote further covered produce that performs the for preparing crop sprays, and water decomposition of cellulose and lignin, commercial processing described in used for growing sprouts) and in and stabilize composition. paragraph (b)(1) of this section; and harvesting, packing, and holding (3) The requirements of this subpart activities (including water used for Direct water application method and subpart Q of this part apply to such washing or cooling harvested produce means using agricultural water in a produce. and water used for preventing manner whereby the water is intended dehydration of covered produce). to, or is likely to, contact covered § 112.3 What definitions apply to this part? Animal excreta means solid or liquid produce or food-contact surfaces during (a) The definitions and interpretations animal waste. use of the water. of terms in section 201 of the Federal Application interval means the time Farm means a facility (as defined in Food, Drug, and Cosmetic Act (21 U.S.C. interval between application of an § 1.227 of this chapter) in one general 321) apply to such terms when used in agricultural input (such as a biological physical location devoted to the this part. soil amendment of animal origin) to a growing and harvesting of crops, the (b) For the purpose of this part, the growing area and harvest of covered raising of animals (including seafood) or following definitions of very small produce from the growing area where both. Farm includes: business and small business also apply: the agricultural input was applied. (i) Facilities that pack or hold food, (1) Very small business. For the Biological soil amendment means any provided that all food used in such purpose of this part, your farm is a very soil amendment containing biological activities is grown, raised, or consumed

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on that farm or another farm under the include activities that transform a raw products, eggs, carcasses, blood meal, same ownership; and agricultural commodity, as defined in bone meal, fish meal, shellfish waste (ii) Facilities that manufacture/ section 201(r) of the Federal Food, Drug, (such as crab, shrimp, and lobster process food, provided that all food and Cosmetic Act, into a processed food waste), fish emulsions, and offal) and is used in such activities is consumed on as defined in section 201(gg) of the generated by commercial, institutional, that farm or another farm under same Federal Food, Drug, and Cosmetic Act. or agricultural operations. ownership. Humus means a stabilized (i.e., Packaging (when used as a verb) Food means food as defined in section finished) biological soil amendment means placing food into a container that 201(f) of the Federal Food, Drug, and produced through a controlled directly contacts the food and that the Cosmetic Act and includes seeds and composting process. consumer receives. beans used to grow sprouts. Manufacturing/processing means Packing means placing food into a Food-contact surfaces means those making food from one or more container other than packaging the food. surfaces that contact human food and ingredients, or synthesizing, preparing, For farms and farm mixed-type those surfaces from which drainage, or treating, modifying or manipulating facilities, packing also includes other transfer, onto the food or onto food, including food crops or activities (which may include surfaces that contact the food ordinarily ingredients. Examples of packaging) traditionally performed by occurs during the normal course of manufacturing/processing activities are farms to prepare raw agricultural operations. ‘‘Food-contact surfaces’’ cutting, peeling, trimming, washing, commodities grown or raised on the includes food-contact surfaces of waxing, eviscerating, rendering, same farm or another farm under the equipment and tools used during cooking, baking, freezing, cooling, same ownership for storage and harvest, packing and holding. pasteurizing, homogenizing, mixing, transport, but does not include activities Growth media means material that formulating, bottling, milling, grinding, that transform a raw agricultural acts as a substrate during the growth of extracting juice, distilling, labeling, or commodity, as defined in section 201(r) covered produce (such as mushrooms packaging. For farms and farm mixed- of the Federal Food, Drug, and Cosmetic and some sprouts) that contains, may type facilities, manufacturing/ Act, into a processed food as defined in contain, or consists of components that processing does not include activities section 201(gg) of the Federal Food, may include any animal waste (such as that are part of harvesting, packing, or Drug, and Cosmetic Act. humus, manure, non-fecal animal holding. Pest means any objectionable animals byproducts or table waste). Manure means animal excreta, alone or insects including birds, rodents, flies, Harvesting applies to farms and farm or in combination with litter (such as and larvae. mixed-type facilities and means straw and feathers used for animal Pre-consumer vegetative waste means activities that are traditionally bedding) for use as a soil amendment. solid waste that is purely vegetative in performed by farms for the purpose of Microorganisms means yeasts, molds, origin, not considered yard trash, and removing raw agricultural commodities bacteria, viruses, protozoa, and derived from commercial, institutional, from the place they were grown or microscopic parasites and includes or agricultural operations without raised and preparing them for use as species having public health coming in contact with animal products, food. Harvesting is limited to activities significance. The term ‘‘undesirable byproducts or manure or with an end performed on raw agricultural microorganisms’’ includes those user (consumer). Pre-consumer commodities on the farm on which they microorganisms that are of public health vegetative waste includes material were grown or raised, or another farm significance, that subject food to generated by farms, packing houses, under the same ownership. Harvesting decomposition, that indicate that food is canning operations, wholesale does not include activities that contaminated with filth, or that distribution centers and grocery stores; transform a raw agricultural commodity, otherwise may cause food to be products that have been removed from as defined in section 201(r) of the adulterated. their packaging (such as out-of-date Federal Food, Drug, and Cosmetic Act, Mixed-type facility means an juice, vegetables, condiments, and into a processed food as defined in establishment that engages in both bread); and associated packaging that is section 201(gg) of the Federal Food, activities that are exempt from vegetative in origin (such as paper or Drug, and Cosmetic Act. Gathering, registration under section 415 of the corn-starch based products). Pre- washing, trimming of outer leaves of, Federal Food, Drug, and Cosmetic Act consumer vegetative waste does not removing stems and husks from, sifting, (21 U.S.C. 350d) and activities that include table waste, packaging that has filtering, threshing, shelling, and require the establishment to be come in contact with materials (such as cooling raw agricultural commodities registered. An example of such a facility meat) that are not vegetative in origin, grown on a farm or another farm under is a ‘‘farm mixed-type facility,’’ which is or any waste generated by restaurants. the same ownership are examples of an establishment that grows and Produce means any fruit or vegetable harvesting. harvests crops or raises animals and (including mixes of intact fruits and Hazard means any biological agent may conduct other activities within the vegetables) and includes mushrooms, that is reasonably likely to cause illness farm definition, but also conducts sprouts (irrespective of seed source), or injury in the absence of its control. activities that require the establishment peanuts, tree nuts and herbs. A fruit is Holding means storage of food. to be registered. the edible reproductive body of a seed Holding facilities include warehouses, Monitor means to conduct a planned plant or tree nut (such as apple, orange cold storage facilities, storage silos, sequence of observations or and almond) such that fruit means the grain elevators, and liquid storage tanks. measurements to assess whether a harvestable or harvested part of a plant For farms and farm mixed-type process, point or procedure is under developed from a flower. A vegetable is facilities, holding also includes control and, when applicable, to the edible part of an herbaceous plant activities traditionally performed by produce an accurate record of the (such as cabbage or potato) or fleshy farms for the safe or effective storage of observation or measurement. fruiting body of a fungus (such as white raw agricultural commodities grown or Non-fecal animal byproduct means button or shiitake) grown for an edible raised on the same farm or another farm solid waste (other than excreta) that is part such that vegetable means the under the same ownership, but does not animal in origin (such as meat, fat, dairy harvestable or harvested part of any

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plant or fungus whose fruit, fleshy condition of soil in relation to plant wooden pallets, and associated rocks fruiting bodies, seeds, roots, tubers, growth or to improve the capacity of the and soils. bulbs, stems, leaves, or flower parts are soil to hold water. The term soil You means a person who is subject to used as food and includes mushrooms, amendment also includes growth media some or all of the requirements in this sprouts, and herbs (such as basil or that serve as the entire substrate during part. cilantro). Produce does not include food the growth of covered produce (such as § 112.4 Who is subject to the requirements grains meaning the small, hard fruits or mushrooms and some sprouts). of this part? seeds of arable crops, or the crops Spent sprout irrigation water means (a) Except as provided in paragraph bearing these fruits or seeds, that are water that has been used in the growing grown and processed for use as meal, (b) of this section, if you are a farm or of sprouts. farm mixed-type facility with an average flour, baked goods, cereals and oils Static composting means a process to annual monetary value of food (as rather than for fresh consumption produce humus in which air is ‘‘food’’ defined in § 112.3(c)) sold (including cereal grains, pseudo cereals, introduced into biological material (in a during the previous 3-year period of oilseeds and other plants used in the pile (or row) covered with at least 6 more than $25,000 (on a rolling basis), same fashion). Examples of food grains inches of insulating material, or in an you are a ‘‘covered farm’’ subject to this include barley, dent- or flint-corn, enclosed vessel) by a mechanism that part. If you are a covered farm subject sorghum, oats, rice, rye, wheat, does not include turning. Examples of to this part, you must comply with all amaranth, quinoa, buckwheat, cotton structural features for introducing air applicable requirements of this part seed, and soybeans. include embedded perforated pipes and when you conduct a covered activity on Production batch of sprouts means all a constructed permanent base that covered produce. sprouts that are started at the same time includes aeration slots. Examples of (b) You are not a covered farm if you in a single growing unit (e.g., a single mechanisms for introducing air include satisfy the requirements in § 112.5 and drum or bin, or a single rack of trays passive diffusion and mechanical means we have not withdrawn your exemption that are connected to each other), (such as blowers that suction air from in accordance with the requirements of whether or not the sprouts are grown the composting material or blow air into subpart R of this part. from a single lot of seed (including, for the composting material using positive example, when multiple types of seeds pressure). § 112.5 Who is eligible for a qualified are grown in a single growing unit). Surface water means all water which exemption and associated modified requirements based on average monetary Qualified end-user with respect to a is open to the atmosphere and subject to food means the consumer of the food; or value of all food sold and direct farm surface runoff, including water obtained marketing? a restaurant or retail food establishment from an underground aquifer that is (as those terms are defined in § 1.227) (a) You are eligible for a qualified held or conveyed in a manner that is exemption and associated modified that is located: open to the atmosphere, such as in (i) In the same State as the farm that requirements in a calendar year if: canals, ponds, other surface (1) During the previous 3-year period produced the food; or containment or open conveyances. (ii) Not more than 275 miles from preceding the applicable calendar year, Table waste means any post-consumer such farm. The term ‘‘consumer’’ does the average annual monetary value of food waste, irrespective of whether the not include a business. the food (as defined in § 112.3(c)) you Raw agricultural commodity (RAC) source material is animal or vegetative sold directly to qualified end-users (as means ‘‘raw agricultural commodity’’ as in origin, derived from individuals, defined in § 112.3(c)) during such defined in section 201(r) of the Federal institutions, restaurants, retail period exceeded the average annual Food, Drug, and Cosmetic Act. operations, or other sources where the monetary value of the food you sold to Reasonably foreseeable hazard means food has been served to a consumer. all other buyers during that period; and a potential hazard that may be Turned composting means a process (2) The average annual monetary associated with the farm or the food. to produce humus in which air is value of all food (as defined in Sanitize means to adequately treat introduced into biological material (in a § 112.3(c)) you sold during the 3-year cleaned food-contact surfaces by a pile, row, or enclosed vessel) by turning period preceding the applicable process that is effective in destroying on a regular basis. Turning is the calendar year was less than $500,000, vegetative cells of microorganisms of process of mechanically mixing adjusted for inflation. public health significance, and in biological material that is undergoing a (b) For the purpose of determining substantially reducing numbers of other composting process with the specific whether the average annual monetary undesirable microorganisms, but intention of moving the outer, cooler value of all food sold during the 3-year without adversely affecting the product sections of the material being period preceding the applicable or its safety for the consumer. composted to the inner, hotter sections. calendar year was less than $500,000, Sewage sludge biosolids means the Water distribution system means a adjusted for inflation, the baseline year solid or semi-solid residue generated system to carry water from its primary for calculating the adjustment for during the treatment of domestic sewage source to its point of use, including inflation is 2011. pipes, sprinklers, irrigation canals, in a treatment works within the § 112.6 What modified requirements apply meaning of the definition of ‘‘sewage pumps, valves, storage tanks, reservoirs, to me if I am eligible for a qualified sludge’’ in 40 CFR 503.9(w). meters, and fittings. exemption in accordance with § 112.5? Soil amendment means any chemical, We means the U.S. Food and Drug (a) If you are eligible for a qualified biological, or physical material (such as Administration (FDA). exemption in accordance with § 112.5, elemental fertilizers, humus, manure, Yard trimmings means purely you are subject to the requirements of: non-fecal animal byproducts, peat moss, vegetative matter resulting from (1) This subpart A; and perlite, pre-consumer vegetative waste, landscaping maintenance or land (2) Subparts Q and R of this part. sewage sludge biosolids, table waste, clearing operations, including materials (b) In addition, you are subject to the agricultural tea and yard trimmings) such as tree and shrub trimmings, grass following modified requirements: intentionally added to the soil to clippings, palm fronds, trees, tree (1) When a food packaging label is improve the chemical or physical stumps, untreated lumber, untreated required on food that would otherwise

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be covered produce under the Federal tea that contains compost agricultural assigned duties in a manner that ensures Food, Drug, and Cosmetic Act or its tea additives; and compliance with this part. implementing regulations, you must (4) The minimum application interval (c) Training must be conducted in a include prominently and conspicuously established in § 112.56(a)(4)(i) for a manner that is easily understood by on the food packaging label the name biological soil amendment of animal personnel being trained. and the complete business address of origin treated by a composting process (d) Training must be repeated as the farm where the produce was grown. that is reasonably likely to contact necessary and appropriate in light of (2) When a food packaging label is not covered produce after application. observations or information indicating required on food that would otherwise (b) You may establish and use an that personnel are not meeting be covered produce under the Federal alternative to any of the requirements standards established by FDA in Food, Drug, and Cosmetic Act, you must listed in paragraph (a) of this section, subparts C through O of this part. prominently and conspicuously display, provided you have adequate scientific at the point of purchase, the name and data or information to support a § 112.22 What minimum requirements apply for training personnel who conduct a complete business address of the farm conclusion that the alternative would covered activity? where the produce was grown, on a provide the same level of public health label, poster, sign, placard, or protection as the applicable requirement (a) At a minimum, all personnel who documents delivered established in this part (including handle (contact) covered produce contemporaneously with the produce in meeting the same microbiological during covered activities or supervise the normal course of business, or, in the standards, where applicable), and the conduct of such activities must case of Internet sales, in an electronic would not increase the likelihood that receive training that includes all of the notice. your covered produce will be following: (3) The complete business address adulterated under section 402 of the (1) Principles of food hygiene and that you must include in accordance Federal Food, Drug, and Cosmetic Act, food safety; with the requirements of paragraph in light of your covered produce, (2) The importance of health and (b)(1) or (b)(2) of this section must practices, and conditions, including personal hygiene for all personnel and include the street address or post office agro-ecological conditions and visitors, including recognizing box, city, state, and zip code for application interval. symptoms of a health condition that is domestic farms, and comparable full (c) Scientific data and information reasonably likely to result in address information for foreign farms. used to support an alternative to a contamination of covered produce or requirement listed in paragraph (a) of food-contact surfaces with Subpart B—General Requirements this section may be developed by you, microorganisms of public health available in the scientific literature, or significance; and § 112.11 What general requirements apply (3) The standards established by FDA to persons who are subject to this part? available to you through a third party. You must establish and maintain in subparts C through O of this part that You must take appropriate measures documentation of the scientific data and are applicable to the employee’s job to minimize the risk of serious adverse information on which you rely in responsibilities. health consequences or death from the accordance with the requirements of (b) Persons who conduct harvest use of, or exposure to, covered produce, subpart O of this part. activities for covered produce must also including those measures reasonably receive training that includes all of the necessary to prevent the introduction of Subpart C—Standards Directed to following: known or reasonably foreseeable Personnel Qualifications and Training (1) Recognizing covered produce that hazards into covered produce, and to should not be harvested, including provide reasonable assurances that the § 112.21 What requirements apply covered produce that may be produce is not adulterated under section regarding qualifications and training for contaminated with known or reasonably 402 of the Federal Food, Drug, and personnel who handle (contact) covered foreseeable hazards; produce or food-contact surfaces? Cosmetic Act (21 U.S.C. 342) on account (2) Inspecting harvest containers and of such hazards. All of the following requirements equipment to ensure that they are apply regarding qualifications and functioning properly, clean, and § 112.12 Are there any alternatives to the training for personnel who handle maintained so as not to become a source requirements established in this part? (contact) covered produce or food- of contamination of covered produce (a) You may establish alternatives to contact surfaces: with known or reasonably foreseeable the following specific requirements of (a) All personnel (including hazards; and this part, provided that you satisfy the temporary, part time, seasonal, and (3) Correcting problems with harvest requirements of paragraphs (b) and (c) of contracted personnel) who handle containers or equipment, or reporting this section: covered produce or food-contact such problems to the supervisor (or (1) The requirements in § 112.44(c) for surfaces, or who are engaged in the other responsible party), as appropriate testing water, and taking action based supervision thereof, must receive to the person’s job responsibilities. on test results, when agricultural water adequate training, as appropriate to the (c) At least one supervisor or is used during growing operations for person’s duties, upon hiring, at the responsible party for your farm must covered produce (other than sprouts) beginning of each growing season (if have successfully completed food safety using a direct water application method; applicable), and periodically thereafter. training at least equivalent to that (2) Composting treatment processes (b) All personnel (including received under standardized curriculum established in § 112.54(c)(1) and (c)(2); temporary, part time, seasonal, and recognized as adequate by the Food and (3) The minimum application interval contracted personnel) who handle Drug Administration. established in § 112.56(a)(1)(i) for an covered produce or food-contact untreated biological soil amendment of surfaces, or who are engaged in the § 112.23 What requirements apply animal origin that is reasonably likely to supervision thereof, must have the regarding supervisors? contact covered produce after training, in combination with education You must assign or identify personnel application or for a compost agricultural or experience to perform the person’s to supervise (or otherwise be

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responsible for) your operations to covered produce or food-contact Subpart E—Standards Directed to ensure compliance with the surfaces during a covered activity must Agricultural Water requirements of this part. include all of the following practices: § 112.41 What requirements apply to the § 112.30 Under this subpart, what (1) Maintaining adequate personal quality of agricultural water? requirements apply regarding records? cleanliness to protect against All agricultural water must be safe (a) You must establish and keep contamination of covered produce and and of adequate sanitary quality for its records required under this subpart C in food-contact surfaces; intended use. accordance with the requirements of (2) Avoiding contact with animals subpart O of this part. § 112.42 What measures must I take with other than working animals, and taking respect to my agricultural water sources, (b) You must establish and keep appropriate steps to minimize the records of training that document water distribution system, and pooling of likelihood of contamination of covered water? required training of personnel, produce when in direct contact with (a) At the beginning of a growing including the date of training, topics working animals; covered, and the persons(s) trained. season, you must inspect the entire (3) Washing hands thoroughly, agricultural water system under your Subpart D—Standards Directed to including scrubbing with soap and control (including water source, water Health and Hygiene running water that satisfies the distribution system, facilities, and requirements of § 112.44(a) (as equipment), to identify conditions that § 112.31 What measures must I take to applicable) for water used to wash are reasonably likely to introduce prevent ill or infected persons from known or reasonably foreseeable contaminating covered produce with hands, and drying hands thoroughly microorganisms of public health using single-service towels, clean cloth hazards into or onto covered produce or significance? towels, sanitary towel service or other food-contact surfaces in light of your covered produce, practices, and (a) You must take measures to prevent adequate hand drying devices: conditions, including consideration of contamination of covered produce and (i) Before starting work; the following: food-contact surfaces with (1) The nature of each agricultural microorganisms of public health (ii) Before putting on gloves; water source (for example, ground water significance from any person with an (iii) After using the toilet; or surface water); applicable health condition (such as a (iv) Upon return to the work station (2) The extent of your control over communicable illnesses that present a after any break or other absence from each agricultural water source; public health risk in the context of the work station; (3) The degree of protection of each normal work duties, infection, open agricultural water source; lesion, vomiting, or diarrhea). (v) As soon as practical after touching (4) Use of adjacent or nearby land; (b) The measures you must take to animals (including livestock and and satisfy the requirements of paragraph (a) working animals), or any waste of (5) The likelihood of introduction of of this section must include all of the animal origin; and known or reasonably foreseeable following measures: (vi) At any other time when the hands hazards to agricultural water by another (1) Excluding any person from may have become contaminated in a working in any operations that may user of agricultural water before the manner that is reasonably likely to lead water reaches your covered farm. result in contamination of covered to contamination of covered produce produce or food-contact surfaces with (b) You must adequately maintain all with known or reasonably foreseeable agricultural water sources that are under microorganisms of public health hazards; and significance when the person (by your control (such as wells) by regularly medical examination, the person’s (4) If you choose to use gloves in inspecting each source and keeping the acknowledgement, or observation) is handling covered produce or food- source free of debris, trash, shown to have, or appears to have, an contact surfaces, maintaining gloves in domesticated animals, and other applicable health condition, until the an intact and sanitary condition and possible sources of contamination of person’s health condition no longer replacing such gloves when no longer covered produce to the extent presents a risk to public health; and able to do so. practicable and appropriate under the (2) Instructing personnel to notify circumstances. their supervisor(s) (or a responsible § 112.33 What measures must I take to (c) You must adequately maintain all prevent visitors from contaminating party) if they have, or if there is a agricultural water distribution systems covered produce and food-contact surfaces as necessary and appropriate to prevent reasonable possibility that they have an with microorganisms of public health applicable health condition. the water distribution system from being significance? a source of contamination to covered § 112.32 What hygienic practices must (a) A visitor is any person (other than produce, food-contact surfaces, areas personnel use? personnel) who enters your covered used for a covered activity, or water (a) Personnel who work in an farm with your permission. sources, including by regularly operation in which covered produce or inspecting and adequately storing all food-contact surfaces are at risk of (b) You must make visitors aware of equipment used in the system. contamination with known or policies and procedures to protect (d) You must immediately reasonably foreseeable hazards must use covered produce and food-contact discontinue use of a source of hygienic practices while on duty to the surfaces from contamination by people agricultural water and/or its distribution extent necessary to protect against such and take all steps reasonably necessary system, and not use the water source contamination. to ensure that visitors comply with such and/or its distribution system when you (b) The hygienic practices that policies and procedures. have determined or have reason to personnel use to satisfy the (c) You must make toilet and hand- believe that your agricultural water is requirements of paragraph (a) of this washing facilities accessible to visitors. not safe and of adequate sanitary quality section when handling (contacting) for its intended use, until you either:

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(1) Re-inspect the entire agricultural N of this part to ensure there is no that source of agricultural water and/or water system under your control, detectable generic Escherichia coli (E. its distribution system for the uses identify any conditions that are coli) in 100 milliliters (mL) of described in this paragraph. Before you reasonably likely to introduce known or agricultural water when it is: may use the water source and/or reasonably foreseeable hazards into or (1) Used as sprout irrigation water; distribution system again for the uses onto covered produce or food-contact (2) Applied in any manner that described in this paragraph, you must surfaces, make necessary changes, and directly contacts covered produce either re-inspect the entire agricultural test the water to determine if your during or after harvest activities (for water system under your control, changes were effective and to ensure example, water that is applied to identify any conditions that are that your agricultural water is safe and covered produce for washing or cooling reasonably likely to introduce known or of adequate sanitary quality for its activities, and water that is applied to reasonably foreseeable hazards into or intended use; or harvested crops to prevent dehydration onto covered produce or food-contact (2) Treat the water in accordance with before cooling), including when used to surfaces, make necessary changes, and the requirements of § 112.43. make ice that directly contacts covered retest the water to determine if your (e) As necessary and appropriate, you produce during or after harvest changes were effective; or treat the must implement measures reasonably activities; water in accordance with the necessary to reduce the potential for (3) Used to make a treated agricultural requirements of § 112.43. contamination of covered produce with tea; (d) You may establish and use known or reasonably foreseeable (4) Used to contact food-contact alternatives to the requirements hazards as a result of pooling of water. surfaces, or to make ice that will contact established in paragraph (c) of this For example, such measures may food-contact surfaces; or section, provided you satisfy the (5) Used for washing hands during include using protective barriers or requirements of § 112.12. staking to keep covered produce from and after harvest activities. touching the ground or using an (b) If you find that there is any § 112.45 How often must I test agricultural alternative irrigation method. detectable generic E. coli in 100 mL of water that is subject to the requirements of water, you must immediately § 112.44? § 112.43 What treatment of agricultural discontinue use of that source of (a) You must test any agricultural water is required, and what requirements agricultural water and/or its distribution apply to treating agricultural water? water that is subject to the requirements system for the uses described in of § 112.44 at the beginning of each (a) You must treat any agricultural paragraph (a) of this section. Before you water that you use (such as with an growing season, and every three months may use the water source and/or thereafter during the growing season, EPA-registered antimicrobial pesticide distribution system again for the uses product) if you know or have reason to except that there is no requirement to described in paragraph (a) of this test water when: believe that the water is not safe and of section, you must either re-inspect the (1) You receive water from a Public adequate sanitary quality for its entire agricultural water system under Water System, as defined under the Safe intended use. your control, identify any conditions Drinking Water Act (SDWA) regulations, (b) Any method you use to treat that are reasonably likely to introduce 40 CFR part 141, that furnishes water agricultural water to satisfy the known or reasonably foreseeable that meets the microbial requirements requirement in paragraph (a) of this hazards into or onto covered produce or under those regulations or under the section must be effective to make the food-contact surfaces, make necessary regulations of a State approved to water safe and of adequate sanitary changes, and retest the water to administer the SDWA public water quality for its intended use. determine if your changes were effective (c)(1) You must deliver any treatment supply program, and you have Public and to ensure that the water meets the of agricultural water required by Water System results or certificates of requirements of paragraph (a) of this paragraph (a) of this section in a manner compliance that demonstrate that the section; or treat the water in accordance to ensure that the treated water is water meets that requirement; with the requirements of § 112.43. consistently safe and of adequate (c) When agricultural water is used (2) You receive water from a public sanitary quality for its intended use. during growing activities for covered water supply that furnishes water that (2) You must monitor any treatment of produce (other than sprouts) using a meets the microbial requirement agricultural water at a frequency direct water application method you described in § 112.44(a), and you have adequate to ensure that the treated water must test the quality of water in public water system results or is consistently safe and of adequate accordance with one of the appropriate certificates of compliance that sanitary quality for its intended use. analytical methods in subpart N. If you demonstrate that the water meets that § 112.44 What testing is required for find that there is more than 235 colony requirement; or agricultural water, and what must I do forming units (CFU) (or most probable (3) You treat water in accordance with based on the test results? number (MPN), as appropriate) generic the requirements of § 112.43. (a) You must test the quality of E. coli per 100 mL for any single sample (b) If you use untreated surface water agricultural water according to the or a rolling geometric mean (n=5) of for purposes that are subject to the requirements in § 112.45 using a more than 126 CFU (or MPN, as requirements of § 112.44, you must test quantitative, or presence-absence appropriate) per 100 mL of water, you the water as specified in the table in this method of analysis provided in subpart must immediately discontinue use of paragraph.

Then you must test the untreated surface If the untreated surface water is— water—

(1) From any source where a significant quantity of runoff is likely to drain into the source (for At least every 7 days during the growing sea- example, a river or natural lake). son.

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Then you must test the untreated surface If the untreated surface water is— water—

(2) From any source where underground aquifer water is transferred to a surface water con- At least once each month during the growing tainment constructed and maintained in a manner that minimizes runoff drainage into the season. containment (for example, an on-farm man-made water reservoir).

§ 112.46 What measures must I take for requirements established in § 112.44(c) (b) You must handle, convey and water that I use during harvest, packing, for agricultural water used during store any treated biological soil and holding activities for covered produce? growing activities using a direct water amendment of animal origin in a (a) You must manage the water as application method in accordance with manner and location that minimizes the necessary, including by establishing and the requirements of § 112.44(d). risk of it becoming contaminated by an following water-change schedules for re- (7) Annual documentation of the untreated or in-process biological soil circulated water, to maintain adequate results or certificates of compliance amendment of animal origin. sanitary quality and minimize the from a public water system under (c) You must handle, convey, and potential for contamination of covered 112.45(a)(1) or (a)(2), if applicable. store any biological soil amendment of produce and food-contact surfaces with animal origin that has become known or reasonably foreseeable Subpart F—Standards Directed to contaminated as if it was untreated. hazards (for example, hazards that may Biological Soil Amendments of Animal be introduced into the water from soil Origin and Human Waste § 112.53 What prohibitions apply adhering to the covered produce); regarding use of human waste? (b) You must visually monitor the § 112.51 What requirements apply for You may not use human waste for quality of water that you use during determining the status of a biological soil growing covered produce, except amendment of animal origin? harvest, packing, and holding activities sewage sludge biosolids used in for covered produce (for example, water (a) A biological soil amendment of accordance with the requirements of 40 used for washing covered produce in animal origin is treated if it has been CFR part 503, subpart D, or equivalent dump tanks, flumes, or wash tanks, and processed to completion to adequately regulatory requirements. reduce microorganisms of public health water used for cooling covered produce § 112.54 What treatment processes are in hydrocoolers) for build-up of organic significance in accordance with the requirements of § 112.54, or, in the case acceptable for a biological soil amendment material (such as soil and plant debris). of animal origin that I apply in the growing (c) You must maintain and monitor of an agricultural tea, the biological of covered produce? materials used to make the tea have the temperature of water at a Each of the following treatment been so processed and the water used to temperature that is appropriate for the processes are acceptable for a biological make the tea satisfies the requirements commodity and operation (considering soil amendment of animal origin that of 112.44(a). the time and depth of submersion) and you apply in the growing of covered (b) A biological soil amendment of is adequate to minimize the potential for produce, provided that the resulting infiltration of microorganisms of public animal origin is untreated if it: (1) Has not been processed to biological soil amendments are applied health significance into covered in accordance with the applicable produce. completion in accordance with the requirements of § 112.54, or in the case requirements of § 112.56: (a) A scientifically valid controlled § 112.50 Under this subpart, what of an agricultural tea, the biological physical process (for example, thermal), requirements apply regarding records? materials used to make the tea have not chemical process (for example, high (a) You must establish and keep been so processed or the water used to alkaline pH), or combination of records required under this subpart E in make the tea does not satisfy the scientifically valid controlled physical accordance with the requirements of requirements of 112.44(a); subpart O of this part. (2) Has become contaminated after and chemical processes that has been (b) You must establish and keep the treatment; demonstrated to satisfy the microbial following records: (3) Has been recombined with an standard in § 112.55(a) for Listeria (1) The findings of the inspection of untreated biological soil amendment of monocytogenes (L. monocytogenes), your agricultural water system in animal origin; Salmonella species, and E. coli accordance with the requirements of (4) Is or contains a component that is O157:H7; § 112.42(a); untreated waste that you know or have (b) A scientifically valid controlled (2) Documentation of the results of reason to believe is contaminated with physical process, chemical process, or any analytical tests conducted to a hazard or has been associated with combination of scientifically valid determine whether agricultural water is foodborne illness; or controlled physical and chemical safe and of adequate sanitary quality for (5) Is an agricultural tea that contains processes, that has been demonstrated its intended use; an agricultural tea additive. to satisfy the microbial standard in (3) Scientific data or information you § 112.55(b) for Salmonella and fecal rely on to support the adequacy of a § 112.52 How must I handle, convey, and coliforms; or method used to satisfy the requirements store biological soil amendments of animal (c) A scientifically valid controlled of § 112.43(b) and (c)(1); origin? composting process that has been (4) Documentation of the results of (a) You must handle, convey and store demonstrated to satisfy the microbial water treatment monitoring under any biological soil amendment of standard in § 112.55(b) for Salmonella § 112.43(c)(2); animal origin in a manner and location and fecal coliforms. Scientifically valid (5) Documentation of the results of such that it does not become a potential controlled composting processes water testing you perform to satisfy the source of contamination to covered include: requirements of § 112.44; and produce, food-contact surfaces, areas (1) Static composting that maintains (6) Scientific data or information you used for a covered activity, water aerobic (i.e., oxygenated) conditions at a rely on to support any alternative to the sources, and water distribution systems. minimum of 131 °F (55 °C) for 3 days

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and is followed by adequate curing, (3) Other scientifically valid, § 112.55 What microbial standards apply which includes proper insulation; controlled composting processes, to the treatment processes in § 112.54? (2) Turned composting that maintains provided you satisfy the requirements of The following microbial standards aerobic conditions at a minimum of § 112.12, including that the alternative apply to the treatment processes in 131 °F (55 °C) for 15 days, with a process has been demonstrated to satisfy § 112.54 as set forth in that section. (a) For L. monocytogenes, Salmonella minimum of five turnings, and is the microbial standard in § 112.55(b). species, and E. coli O157:H7, the followed by adequate curing, which relevant standards in the table in this includes proper insulation; or 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 § 112.56 What application requirements the table in this paragraph in species per four grams of total solids and minimum application intervals apply to accordance with the application (dry weight basis); and less than 1,000 biological soil amendments of animal requirements specified in the second origin? MPN fecal coliforms per gram of total column of the table in this paragraph (a) Except as provided in paragraph solids (dry weight basis). and the minimum application intervals (b) of this section, you must apply the specified in the third column of the biological soil amendments of animal table in this paragraph. origin specified in the first column of

And then the If the biological soil amendment of animal origin is— Then the biological soil amendment of animal origin must minimum application be applied— interval is—

(1)(i) Untreated ...... In a manner that does not contact covered produce during 9 months. application and minimizes the potential for contact with covered produce after application (ii) Untreated ...... In a manner that does not contact covered produce during 0 days. or after application (2) Treated by a scientifically valid controlled physical or In any manner (i.e., no restrictions) 0 days. chemical process, or combination of scientifically valid controlled physical and chemical processes, in accord- ance with the requirements of § 112.54(a) to meet the microbial standard in § 112.55(a). (3) Treated by a scientifically valid controlled physical or In a manner that minimizes the potential for contact with 0 days. chemical process, or combination of scientifically valid covered produce during and after application controlled physical and chemical processes, in accord- ance with the requirements of § 112.54(b) to meet the microbial standard in § 112.55(b). (4)(i) Treated by a composting process in accordance with In a manner that minimizes the potential for contact with 45 days. the requirements of § 112.54(c) to meet the microbial covered produce during and after application standard in § 112.55(b). (ii) Treated by a composting process in accordance with In a manner that does not contact covered produce during 0 days. the requirements of § 112.54(c) to meet the microbial or after application standard in § 112.55(b).

(b) You may establish and use (1) Documentation of the date of (i) The process used to treat the alternatives to the minimum application application of any untreated biological biological soil amendment of animal intervals established in paragraphs soil amendment of animal origin origin is a scientifically valid process (a)(1)(i) and (a)(4)(i) of this section, (including raw manure) or any that has been carried out with provided you satisfy the requirements of biological soil amendment of animal appropriate process monitoring; § 112.12. origin treated by composting to a (ii) The applicable treatment process § 112.60 Under this subpart, what growing area and the date of harvest of is periodically verified through testing requirements apply regarding records? covered produce from that growing area, using a scientifically valid analytical (a) You must establish and keep except when covered produce does not method on an adequately representative records required under this subpart F in contact the soil after application of the sample to demonstrate that the process accordance with the requirements of soil amendment; satisfies the applicable microbial standard in § 112.55, including the subpart O of this part. (2) For a treated biological soil results of such periodic testing; and (b) For any biological soil amendment amendment of animal origin you receive of animal origin you use, you must from a third party, documentation (such (iii) The biological soil amendment of establish and keep the following as a Certificate of Conformance) that: animal origin has been handled, records: conveyed and stored in a manner and

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location to minimize the risk of § 112.83 What requirements apply § 112.114 What requirements apply to contamination by an untreated or in- regarding animal intrusion? dropped covered produce? process biological soil amendment of (a) If under the circumstances there is You must not distribute covered animal origin; a reasonable probability that animal produce that drops to the ground before (3) For a treated biological soil intrusion will contaminate covered harvest (dropped covered produce) amendment of animal origin you produce, you must monitor those areas unless it is exempt under § 112.2(b). produce for your own covered farm(s), that are used for a covered activity for Dropped covered produce does not documentation that process controls (for evidence of animal intrusion: include root crops (such as carrots) that example, time, temperature and (1) As needed during the growing grow underground or crops (such as turnings) were achieved; season based on: cantaloupe) that grow on the ground. (i) Your covered produce; and (4) Scientific data or information you § 112.115 What measures must I take (ii) Your observations and experience; when packaging covered produce? rely on to support any alternative and composting process used to treat a You must package covered produce in (2) Immediately prior to harvest. biological soil amendment of animal a manner that prevents the formation of (b) If animal intrusion, as made origin in accordance with the Clostridium botulinum toxin if such evident by observation of significant requirements of § 112.54(c)(3); and toxin is a known or reasonably quantities of animals, animal excreta or foreseeable hazard (such as for (5) Scientific data or information you crop destruction via grazing, occurs, you mushrooms). rely on to support any alternative must evaluate whether the covered minimum application interval in produce can be harvested in accordance § 112.116 What measures must I take accordance with the requirements of with the requirements of § 112.112. when using food-packing (including food § 112.56(b). packaging) material? Subpart J—[Reserved] (a) You must use food-packing Subpart G—[Reserved] material that is adequate for its intended Subpart K—Standards Directed to use. Subpart H—[Reserved] Growing, Harvesting, Packing, and (b) If you reuse food-packing material, Holding Activities you must take steps to ensure that food- Subpart I—Standards Directed to contact surfaces are clean, such as by § 112.111 What measures must I take if I Domesticated and Wild Animals grow, harvest, pack or hold both covered cleaning and sanitizing, when and excluded produce? necessary, food-packing containers or § 112.81 How do the requirements of this using a clean liner. subpart apply to areas where covered If you grow, harvest, pack or hold activities take place? produce that is not covered in this part Subpart L—Standards Directed to (i.e., excluded produce in accordance (a) The requirements of this subpart Equipment, Tools, Buildings, and with § 112.2) and also conduct such apply when a covered activity takes Sanitation activities on covered produce, and the place in an outdoor area or a partially- excluded produce is not grown, § 112.121 What equipment and tools are enclosed building and when, under the harvested, packed or held in accordance subject to the requirements of this subpart? circumstances, there is a reasonable with this part, you must take measures Equipment and tools subject to the probability that animals will during these covered activities, as requirements of this subpart are those contaminate covered produce. applicable, to: that are intended to, or likely to, contact (b) The requirements of this subpart (a) Keep covered produce separate covered produce; and those instruments do not apply when a covered activity from excluded produce; and or controls used to measure, regulate, or takes place in a fully-enclosed building. (b) Adequately clean and sanitize, as record conditions to control or prevent necessary, any food-contact surfaces the growth of undesirable § 112.82 What requirements apply that contact excluded produce before microorganisms or other contamination. regarding domesticated animals that I allow Examples include knives, implements, to graze in fields or use as working animals using such food-contact surfaces for where I grow covered produce? covered activities on covered produce. mechanical harvesters, waxing machinery, cooling equipment At a minimum, if you allow animals § 112.112 What measures must I take (including hydrocoolers), grading belts, to graze or use them as working animals during harvest activities? sizing equipment, palletizing in fields where covered produce is You must take all measures equipment, and equipment used to store grown, and under the circumstances reasonably necessary to identify, and or convey harvested covered produce there is a reasonable probability that not harvest, covered produce that is (such as containers, bins, food-packing grazing or working animals will reasonably likely to be contaminated material, dump tanks, flumes, and contaminate covered produce, you must with a known or reasonably foreseeable vehicles or other equipment used for take the following measures: hazard, including steps to identify and transport that are intended to, or likely (a) An adequate waiting period not harvest covered produce that is to, contact covered produce). between grazing and harvesting for visibly contaminated with animal excreta. § 112.122 What buildings are subject to covered produce in any growing area the requirements of this subpart? that was grazed to ensure the safety of § 112.113 How must I handle harvested Buildings subject to the requirements the harvested crop; and covered produce during covered activities? of this subpart include: (b) If working animals are used in a You must handle harvested covered (a) Any fully- or partially-enclosed growing area where a crop has been produce in a manner that protects building used for covered activities, planted, measures to prevent the against contamination with known or including minimal structures that have introduction of known or reasonably reasonably foreseeable hazards—for a roof but do not have any walls; and foreseeable hazards into or onto covered example, by avoiding contact of cut (b) Storage sheds, buildings, or other produce. surfaces of harvested produce with soil. structures used to store food-contact

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surfaces (such as harvest containers and (b) Adequately maintained; and covered produce, food-contact surfaces, food-packing materials). (c) Adequate in number for their or food-packing material is exposed; or designated uses. (2) Separating domesticated animals § 112.123 What general requirements apply regarding equipment and tools in a fully enclosed building from an area § 112.125 What requirements apply to where a covered activity is conducted subject to this subpart? equipment that is subject to this subpart on covered produce by location, time, or All of the following requirements used in the transport of covered produce? partition. apply regarding equipment and tools Equipment that is subject to this subject to this subpart: (b) Guard or guide dogs may be subpart that you use to transport allowed in some areas of a fully (a) You must use equipment and tools covered produce must be: that are of adequate design, enclosed building if the presence of the (a) Adequately clean before use in dogs is unlikely to result in construction, and workmanship to transporting covered produce; and enable them to be adequately cleaned contamination of produce, food-contact (b) Adequate for use in transporting surfaces, or food-packing materials. and properly maintained; and covered produce. (b) Equipment and tools must be: § 112.128 What requirements apply (1) Installed and maintained as to § 112.126 What design and construction regarding pest control in buildings? facilitate cleaning of the equipment and requirements apply to my buildings? (a) You must take those measures of all adjacent spaces, and All of the following design and (2) Stored and maintained to protect reasonably necessary to protect covered construction requirements apply produce, food-contact surfaces, and covered produce from being regarding buildings. contaminated with known or reasonably food-packing materials from (a) Buildings must be suitable in size, contamination by pests in buildings, foreseeable hazards and to prevent the construction, and design to facilitate equipment and tools from attracting and including routine monitoring for pests maintenance and sanitary operations for as necessary and appropriate. harboring pests. covered activities to reduce the (c) Seams on food-contact surfaces of (b) For fully-enclosed buildings, you potential for contamination of covered equipment and tools that you use must must take measures to exclude pests produce or food-contact surfaces with be either smoothly bonded, or from your buildings. known or reasonably foreseeable maintained to minimize accumulation (c) For partially-enclosed buildings, hazards. Buildings must: of dirt, filth, food particles, and organic you must take measures to prevent pests (1) Provide sufficient space for material and thus minimize the from becoming established in your placement of equipment and storage of opportunity for harborage or growth of buildings (such as by use of screens or materials; microorganisms. by monitoring for the presence of pests (d)(1) You must inspect, maintain, (2) Permit proper precautions to be and removing them when present). and clean and sanitize, when necessary taken to reduce the potential for contamination of covered produce, § 112.129 What requirements apply to and appropriate, all food-contact toilet facilities? surfaces of equipment and tools used in food-contact surfaces, or packing All of the following requirements covered activities as frequently as materials with known or reasonably apply to toilet facilities: reasonably necessary to protect against foreseeable hazards. The potential for (a) You must provide personnel with contamination of covered produce. contamination must be reduced by (2) You must maintain and clean all effective design including the separation adequate, readily accessible toilet non-food-contact surfaces of equipment of operations in which contamination is facilities, including toilet facilities and tools subject to this subpart used likely to occur, by one or more of the readily accessible to growing areas during harvesting, packing, and holding following means: Location, time, during harvesting activities. as frequently as reasonably necessary to partition, enclosed systems, or other (b) Your toilet facilities must be protect against contamination of effective means; and designed, located, and maintained to: covered produce. (3) Be constructed in such a manner (1) Prevent contamination of covered (e) If you use equipment such as that floors, walls, ceilings, fixtures, produce, food-contact surfaces, areas pallets, forklifts, tractors, and vehicles ducts and pipes can be adequately used for a covered activity, water such that they are intended to, or likely cleaned and kept in good repair, and sources, and water distribution systems to, contact covered produce, you must that drip or condensate does not with human waste; do so in a manner that minimizes the contaminate covered produce, food- (2) Be directly accessible for servicing, potential for contamination of covered contact surfaces, or packing materials. be serviced and cleaned on a schedule produce or food-contact surfaces with (b) You must provide adequate sufficient to ensure suitability of use, known or reasonably foreseeable drainage in all areas where normal and be kept supplied with toilet paper; hazards. operations release or discharge water or and other liquid waste on the ground or (3) Provide for the sanitary disposal of § 112.124 What requirements apply to floor of the building. waste and toilet paper. instruments and controls used to measure, (c) During growing activities that take regulate, or record? § 112.127 What requirements apply place in a fully-enclosed building, and Instruments or controls you use to regarding domesticated animals in and during covered harvesting, packing, or around a fully-enclosed building? measure, regulate, or record holding activities, you must provide a temperatures, hydrogen-ion (a) You must take reasonable hand-washing station in sufficiently concentration (pH), sanitizer efficacy or precautions to prevent contamination of close proximity to toilet facilities to other conditions, in order to control or covered produce, food-contact surfaces, make it practical for persons who use prevent the growth of undesirable and food-packing materials in fully- the toilet facility to wash their hands. microorganisms or other contamination, enclosed buildings with known or must be: reasonably foreseeable hazards from § 112.130 What requirements apply for (a) Accurate and precise as necessary domesticated animals by: hand-washing facilities? and appropriate in keeping with their (1) Excluding domesticated animals All of the following requirements purpose; from fully-enclosed buildings where apply to hand-washing facilities:

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(a) You must provide personnel with § 112.132 What must I do to control and accordance with the requirements of adequate, readily accessible hand- dispose of trash, litter, and waste in areas subpart O of this part. washing facilities during growing used for covered activities? (b) You must establish and keep activities that take place in a fully- All of the following requirements documentation of the date and method enclosed building, and during covered apply to the control and disposal of of cleaning and sanitizing of equipment harvest, packing, or holding activities. trash, litter, and waste in areas used for subject to this subpart used in: (b) Your hand-washing facilities must covered activities: (1) Growing operations for sprouts; be furnished with: (a) You must convey, store, and and (1) Soap (or other effective surfactant); dispose of trash, litter and waste to: (2) Covered harvesting, packing, or (2) Running water that satisfies the (1) Minimize the potential for trash, holding activities. requirements of § 112.44(a) for water litter, or waste to attract or harbor pests; Subpart M—Standards Directed to used to wash hands; and and (2) Protect against contamination of Sprouts (3) Adequate drying devices (such as covered produce, food-contact surfaces, single service towels, clean cloth towels § 112.141 What requirements apply to areas used for a covered activity, or sanitary towel service). seeds or beans used to grow sprouts? agricultural water sources, and (c) You must provide for appropriate agricultural water distribution systems In addition to the requirements of this disposal of waste (for example, waste with known or reasonably foreseeable part, all of the following requirements water and used single-service towels) hazards. apply to seeds or beans used to grow associated with a hand-washing facility (b) You must adequately operate sprouts. and take appropriate measures to systems for waste treatment and (a) If your farm grows seeds or beans prevent waste water from a hand- disposal so that they do not constitute for use to grow sprouts, you must take washing facility from contaminating a potential source of contamination in measures reasonably necessary to covered produce, food-contact surfaces, areas used for a covered activity. prevent the introduction of known or areas used for a covered activity, reasonably foreseeable hazards into or agricultural water sources, and § 112.133 What requirements apply to onto seeds or beans that you will use for agricultural water distribution systems plumbing? sprouting. with known or reasonably foreseeable The plumbing must be of an adequate (b) If you know or have reason to hazards. size and design and be adequately believe that a lot of seeds or beans have (d) You may not use hand antiseptic/ installed and maintained to: been associated with foodborne illness, sanitizer or wipes as a substitute for (a) Distribute water under pressure as you must not use that lot of seeds or soap and water. needed, in sufficient quantities, in all beans to produce sprouts. areas where used for covered activities, (c) You must visually examine seeds § 112.131 What must I do to control and for sanitary operations, or for hand- and beans, and packaging used to ship dispose of sewage? washing and toilet facilities. seeds or beans, for signs of potential All of the following requirements (b) Properly convey sewage and liquid contamination with known or apply for the control and disposal of disposable waste; reasonably foreseeable hazards. sewage: (c) Avoid being a source of (a) You must dispose of sewage into contamination to covered produce, § 112.142 What measures must I take for an adequate sewage or septic system or growing, harvesting, packing, and holding food-contact surfaces, areas used for a sprouts? through other adequate means. covered activity, or agricultural water (b) You must maintain sewage and sources; and You must take all of the following septic systems in a manner that prevents (d) Not allow backflow from, or cross measures for growing, harvesting, contamination of covered produce, connection between, piping systems packing, and holding sprouts: food-contact surfaces, areas used for a that discharge waste water or sewage (a) You must grow, harvest, pack, and covered activity, agricultural water and piping systems that carry water hold sprouts in a fully-enclosed sources, and agricultural water used for a covered activity, for sanitary building. distribution systems with known or operations, or for use in hand-washing (b) Any food-contact surfaces you use reasonably foreseeable hazards. facilities. to grow, harvest, pack, and hold sprouts must be cleaned and sanitized before (c) You must manage and dispose of § 112.134 What must I do to control animal contact with sprouts or seeds or beans leakages or spills of human waste in a excreta and litter from domesticated used to grow sprouts. manner that prevents contamination of animals that are under my control? (c) You must treat seeds or beans that covered produce, and prevents or (a) If you have domesticated animals, will be used to grow sprouts using a minimizes contamination of food- to prevent contamination of covered scientifically valid method immediately contact surfaces, areas used for a produce, food-contact surfaces, areas before sprouting to reduce covered activity, agricultural water used for a covered activity, agricultural microorganisms of public health sources, or agricultural water water sources, or agricultural water significance. Prior treatment conducted distribution systems. distribution systems with animal waste, by a grower, handler, or distributor of (d) After a significant event (such as you must: seeds or beans does not eliminate your flooding or an earthquake) that could (1) Adequately control their excreta responsibility to treat seeds or beans negatively impact a sewage or septic and litter; and immediately before sprouting at your system, you must take appropriate steps (2) Maintain a system for control of covered farm. to ensure that sewage and septic animal excreta and litter. systems continue to operate in a manner (b) [Reserved] § 112.143 What testing must I do during that does not contaminate covered growing, harvesting, packing, and holding produce, food-contact surfaces, areas § 112.140 Under this subpart L, what sprouts? used for a covered activity, agricultural requirements apply regarding records? All of the following testing must be water sources, or agricultural water (a) You must establish and keep done during growing, harvesting, distribution systems. records required under this subpart L in packing, and holding sprouts:

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(a) You must test the growing, (a) Conduct additional testing of (4) The results of all testing conducted harvesting, packing, and holding surfaces and areas surrounding the area in accordance with the requirements of environment for Listeria species or L. where Listeria species or L. §§ 112.143 and 112.144; monocytogenes in accordance with the monocytogenes was detected to evaluate (5) Any analytical methods you use in requirements of § 112.144. the extent of the problem, including the lieu of the methods that are (b) You must either: potential for Listeria species or L. incorporated by reference in § 112.152; (1) Test spent sprout irrigation water monocytogenes to have become and from each production batch of sprouts established in a niche; (6) The testing method you use in for E. coli O157:H7 and Salmonella (b) Clean and sanitize the affected accordance with the requirements of species in accordance with the surfaces and surrounding areas; § 112.146(b). requirements of § 112.146; or (c) Conduct additional microbial (2) If testing spent sprout irrigation sampling and testing to determine Subpart N—Analytical Methods water is not practicable (for example, for whether the Listeria species or L. soil-grown sprouts), test each § 112.151 What methods must I use to test monocytogenes has been eliminated; the quality of water to satisfy the production batch of sprouts at the in- (d) Conduct finished product testing requirements of § 112.45 process stage (i.e., while sprouts are still when appropriate; and (a) You must test the quality of water growing) for E. coli O157:H7 and (e) Perform any other actions using a method of analysis: Salmonella species in accordance with necessary to prevent reoccurrence of the (1) As published in the ‘‘Official the requirements of § 112.146. contamination. Methods of Analysis of the Association § 112.144 What requirements apply to § 112.146 What must I do to collect and of Official Analytical Chemists (AOAC) testing the environment for Listeria species test samples of spent sprout irrigation International’’ (18th ed., revision 4, or L. monocytogenes? water or sprouts? 2011) which is incorporated by All of the following testing All of the following requirements reference in accordance with 5 U.S.C. requirements apply for the growing, apply for collecting and testing samples 552(a) and 1 CFR part 51. Copies are harvesting, packing, and holding of spent sprout irrigation water or available from the AOAC International, environment for Listeria species or L. sprouts: 481 North Frederick Ave., suite 500, monocytogenes. (a) You must establish and implement Gaithersburg, MD 20877, or at the (a) You must establish and implement a written sampling plan that identifies National Archives and Records a written environmental monitoring the number and location of samples (of Administration (NARA). For plan that is designed to identify L. spent sprout irrigation water or sprouts) information on the availability of this monocytogenes if it is present in the to be collected for each production material at NARA, call 202–741–6030, growing, harvesting, packing, or holding batch of sprouts to ensure that the or go to http://www.archives.gov/ _ environment. collected samples are representative of federal register/ _ _ _ (b) Your written environmental the production batch when testing for code of federal regulations/ _ monitoring plan must be directed to contamination. ibr locations.html; or sampling and testing for either Listeria (b) In accordance with the written (2) As published in the Standards species or L. monocytogenes. sampling plan required under paragraph Methods for the Examination of Water (c) Your written environmental (a) of this section, you must aseptically and Wastewater (21st ed., 2005), monitoring plan must include a collect samples of spent sprout American Public Health Association sampling plan that specifies: (APHA), which is incorporated by (1) What you will test collected irrigation water or sprouts, and test the collected samples for E. coli O157:H7 reference in accordance with 5 U.S.C. samples for (i.e., Listeria species or L. 552(a) and 1 CFR part 51. You may monocytogenes); and Salmonella species using a method that has been validated for its intended obtain a copy from the APHA, 800 I St. (2) How often you will collect NW., Washington, DC 20001, 202–777– environmental samples, which must be use (testing spent sprout irrigation water or sprouts) to ensure that the testing is 2742. You may inspect a copy at the no less than monthly; and Center for Food Safety and Applied (3) Sample collection sites; the accurate, precise, and sensitive in detecting these pathogens. Nutrition’s Library, 5100 Paint Branch number and location of sampling sites Pkwy., College Park, MD 20740, 240– must be sufficient to determine whether § 112.150 Under this subpart, what 402–2163, or at the National Archives measures are effective and must include requirements apply regarding records? and Records Administration (NARA). appropriate food-contact surfaces and (a) You must establish and keep For information on the availability of non-food-contact surfaces of equipment, records required under this subpart M this material at NARA, call 202–741– and other surfaces within the growing, in accordance with the requirements of 6030, or go to http://www.archives.gov/ harvesting, packing, and holding subpart O of this part. federal_register/ environment. (b) You must establish and keep the code_of_federal_regulations/ (d) You must collect environmental following records: ibr_locations.html; or samples and test them for Listeria (1) Documentation of your treatment (3) As prescribed in Chapter 4 of the species or L. monocytogenes according of seeds or beans to reduce FDA Bacteriological Analytical Manual to the method in § 112.152. microorganisms of public health (BAM) (Edition 8, Revision A, 1998), as § 112.145 What actions must I take if the significance in the seeds or beans, at updated in June 2011. The Director of growing, harvesting, packing, or holding your farm; the Federal Register approves the environment tests positive for Listeria (2) Your written environmental incorporation by reference of FDA’s species or L. monocytogenes? monitoring plan in accordance with the BAM, Chapter 4 (Edition 8, Revision A, You must take the following actions if requirements of § 112.144; 1998), as updated in June 2011, in you detect Listeria species or L. (3) Your written sampling plan for accordance with 5 U.S.C. 552(a) and 1 monocytogenes in the growing, each production batch of sprouts in CFR part 5. You may obtain a copy of harvesting, packing, or holding accordance with the requirements of the method from Office of Regulatory environment: § 112.146(a); Science, Center for Food Safety and

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Applied Nutrition (CFSAN), Food and (ii) Actual values and observations § 112.165 What formats are acceptable for Drug Administration, 5100 Paint Branch obtained during monitoring; the records I keep? Pkwy., College Park, MD 20740, 240– (iii) An adequate description (such as You must keep records as: 402–1990, or you may examine a copy the commodity name, or the specific (a) Original records; at CFSAN’s Library, 5100 Paint Branch variety or brand name of a commodity, (b) True copies (such as photocopies, Pkwy., College Park, MD, 240–402– and, when available, any lot number or pictures, scanned copies, microfilm, 2163, or at the National Archives and other identifier) of covered produce microfiche, or other accurate Records Administration (NARA). For applicable to the record; reproductions of the original records); or information on the availability of this (iv) The location of a growing area (for (c) Electronic records, in compliance material at NARA, call 202–741–6030, example, a specific field) or other area with part 11 of this chapter. or go to: http://www.archives.gov/ (for example, a specific packing shed) § 112.166 What requirements apply for federal_register/ applicable to the record; and _ _ _ making records available and accessible to code of federal regulation/ (v) The date and time of the activity FDA? ibr_locations.html; or documented; (a) You must have all records required (4) That is at least equivalent to the (2) Be created at the time an activity under this part readily available and appropriate method of analysis in is performed or observed; accessible during the retention period §§ 112.151(a)(1), (a)(2) or (a)(3) in (3) Be accurate, legible, and indelible; for inspection and copying by FDA accuracy, precision, and sensitivity. and upon oral or written request, except that § 112.152 What methods must I use to test (4) Be dated, and signed or initialed you have 24 hours to obtain records you the growing environment for Listeria by the person who performed the keep offsite and make them available species or L. monocytogenes to satisfy the activity documented. and accessible to FDA for inspection requirements of § 112.143(a) and § 112.144? (b) When records are required to be and copying. You must test the growing established and kept in subparts C, E, F, (b) If you use electronic techniques to environment by testing for the presence L, and M of this part (§§ 112.30, 112.50, keep records, or to keep true copies of of Listeria species or L. monocytogenes 112.60, 112.140, and 112.150), you must records, or if you use reduction in environmental samples using the establish and keep documentation of techniques such as microfilm to keep methods and procedures described in actions you take when a standard in true copies of records, you must provide Chapter 10 of FDA’s Bacteriological those subparts is not met. the records to FDA in a format in which Analytical Manual (BAM) April 2011, (c) Records required under they are accessible and legible. Edition (Edition 8, Revision A, 1998), or §§ 112.50(b)(4), 112.50(b)(5), (c) If your farm is closed for a a method that is at least equivalent in 112.60(b)(1), 112.60(b)(3), 112.140, prolonged period, the records may be accuracy, precision, and sensitivity. The 112.150(b)(1), 112.150(b)(4), and transferred to some other reasonably Director of the Federal Register 112.161(b), must be reviewed, dated, accessible location but must be returned approves the incorporation by reference and signed, within a reasonable time to your farm within 24 hours for official of FDA’s BAM, Chapter 10—‘‘Listeria after the records are made, by a review upon request. monocytogenes, Detection and supervisor or responsible party. § 112.167 Can records that I provide to Enumeration of Listeria monocytogenes FDA be disclosed to persons outside FDA? in Foods,’’ April 2011, in accordance § 112.162 Where must I store records? with 5 U.S.C. 552(a) and 1 CFR part 5. (a) Offsite storage of records is Records required by this part are You may obtain a copy of the method permitted after 6 months following the subject to the disclosure requirements from Office of Regulatory Science, date the record was made if such under part 20 of this chapter. records can be retrieved and provided Center for Food Safety and Applied Subpart P—Variances Nutrition (CFSAN), Food and Drug onsite within 24 hours of request for Administration, 5100 Paint Branch official review. § 112.171 Who may request a variance Pkwy., College Park, MD 20740, 240– (b) Electronic records are considered from the requirements of this part? 402–1990, or you may examine a copy to be onsite at your farm if they are A State or a foreign country from at CFSAN’s Library, 5100 Paint Branch accessible from an onsite location at which food is imported into the United Pkwy., College Park, MD, 240–402– your farm. States may request a variance from one 2163, or at the National Archives and or more requirements of this part, where § 112.163 May I use existing records to Records Administration (NARA). For satisfy the requirements of this part? the State or foreign country determines information on the availability of this that: material at NARA, call 202–741–6030, Yes. The regulations in this part do (a) The variance is necessary in light or go to: http://www.archives.gov/ not require duplication of existing of local growing conditions; and federal_register/ records if those records contain all of (b) The procedures, processes, and code_of_federal_regulation/ the information required by this part. practices to be followed under the _ ibr locations.html. § 112.164 How long must I keep records? variance are reasonably likely to ensure that the produce is not adulterated (a) You must keep records required by Subpart O—Requirements Applying to under section 402 of the Federal Food, this part for 2 years past the date the Records That You Must Establish and Drug, and Cosmetic Act (21 U.S.C. 342) record was created. Keep and to provide the same level of public (b) Records that relate to the general § 112.161 What general requirements health protection as the requirements of adequacy of the equipment or processes this part. apply to records required under this part? being used by a farm, including the (a) All records required under this results of scientific studies and § 112.172 How may a State or foreign part must: evaluations, must be retained at the country request a variance from one or (1) Include, as applicable: farm for at least 2 years after the use of more requirements of this part? (i) The name and location of your such equipment or processes is To request a variance from one or farm; discontinued. more requirements of this part, the

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competent authority (e.g., the regulatory (b) Under § 10.30(h)(3) of this chapter, writing and will publish a notice on our authority for food safety) for a State or we will publish a notice in the Federal Web site announcing our decision to a foreign country must submit a petition Register, requesting information and apply the variance to similarly situated under § 10.30 of this chapter. views on a filed petition, including persons in that particular location. information and views from persons § 112.173 What must be included in the who could be affected by the variance § 112.178 Under what circumstances may Statement of Grounds in a petition FDA deny a petition requesting a variance? requesting a variance? if the petition were to be granted (either because their farm is covered by the We may deny a variance request if it In addition to the requirements set petition or as a person similarly situated does not provide the information forth in § 10.30 of this chapter, the to persons covered by the petition). required under § 112.173 (including the Statement of Grounds in a petition (c) Under § 10.30(e)(3) of this chapter, requirements of § 10.30 of this chapter), requesting a variance must: we will respond to the petitioner in or if we determine that the variance is (a) Provide a statement that the writing and will also make public a not reasonably likely to ensure that the applicable State or foreign country has notice on FDA’s Web site announcing produce is not adulterated under section determined that the variance is our decision to either grant or deny the 402 of the Federal Food, Drug and necessary in light of local growing petition. Cosmetic Act (21 U.S.C. 342) and to conditions and that the procedures, (1) If we grant the petition, either in provide the same level of public health processes, and practices to be followed whole or in part, we will specify the protection as the requirements of this under the variance are reasonably likely persons to whom the variance applies part. to ensure that the produce is not and the provision(s) of this part to adulterated under section 402 of the § 112.179 When does a variance approved which the variance applies. by FDA become effective? Federal Food, Drug and Cosmetic Act (2) If we deny the petition (including (21 U.S.C. 342) and to provide the same partial denials), our written response to A variance approved by FDA becomes level of public health protection as the the petitioner and our public notice effective the date of our written decision requirements of this part; announcing our decision to deny the on the petition. (b) Describe with particularity the petition will explain the reason(s) for § 112.180 Under what circumstances may variance requested, including the the denial. persons to whom the variance would FDA modify or revoke an approved (d) We will make readily accessible to variance? apply and the provision(s) of this part the public, and periodically update, a We may modify or revoke a variance to which the variance would apply; list of filed petitions requesting if we determine that such variance is (c) Present information demonstrating variances, including the status of each not reasonably likely to ensure that the that the procedures, processes, and petition (for example, pending, granted, produce is not adulterated under section practices to be followed under variance or denied). are reasonably likely to ensure that the 402 of the Federal Food, Drug, and produce is not adulterated under section § 112.177 Can an approved variance apply Cosmetic Act (21 U.S.C. 342) and to 402 of the Federal Food, Drug, and to any person other than those identified in provide the same level of public health Cosmetic Act (21 U.S.C. 342) and to the petition requesting that variance? protection as the requirements of this provide the same level of public health (a) A State or a foreign country that part. believes that a variance requested by a protection as the requirements of this § 112.181 What procedures apply if FDA part. petition submitted by another State or determines that an approved variance foreign country should also apply to should be modified or revoked? § 112.174 What information submitted in a similarly situated persons in its petition requesting a variance or submitted jurisdiction may request that the (a) We will provide the following in comments on such a petition are publicly notifications: available? variance be applied to its similarly situated persons by submitting (1) We will notify a State or a foreign We will presume that information comments in accordance with § 10.30 of country directly, in writing at the submitted in a petition requesting a this chapter. These comments must address identified in its petition, if we variance and comments submitted on include the information required in determine that a variance granted in such a petition, including a request that § 112.173. If FDA determines that these response to its petition should be a variance be applied to its similarly comments should instead be treated as modified or revoked. Our direct, written situated persons, does not contain a separate request for a variance, FDA notification will provide the State or information exempt from public will notify the State or foreign country foreign country with an opportunity to disclosure under part 20 of this chapter that submitted these comments that a request an informal hearing under part and would be made public as part of the separate request must be submitted in 16 of this chapter. docket associated with this request. accordance with §§ 112.172 and (2) We will publish a notice of our § 112.175 Who responds to a petition § 112.173. determination that a variance should be requesting a variance? (b) If we grant a petition requesting a modified or revoked in the Federal Register. This notice will establish a The Director or Deputy Directors of variance, in whole or in part, we may public docket so that interested parties the Center for Food Safety and Applied specify that the variance also applies to may submit written submissions on our Nutrition (CFSAN), or the Director, persons in a specific location who are determination. Office of Compliance, CFSAN, responds similarly situated to those identified in (3) When applicable, we will: to a request for a variance. the petition. (c) If we specify that the variance also (i) Notify in writing any States or § 112.176 What process applies to a applies to persons in a specific location foreign countries where a variance petition requesting a variance? who are similarly situated to those applies to similarly situated persons of (a) In general, the procedures set forth identified in the petition, we will our determination that the variance in § 10.30 of this chapter govern our inform the applicable State or foreign should be modified or revoked; response to a petition requesting a country where the similarly situated (ii) Provide those States or foreign variance. persons are located of our decision in countries with an opportunity to request

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an informal hearing under part 16 of Subpart Q—Compliance and § 112.202 What procedure will FDA use to this chapter; and Enforcement withdraw an exemption? (iii) Include in the Federal Register (a) If FDA determines that a qualified notice described in paragraph (a)(2) of § 112.191 How do the criteria and exemption applicable to a farm under this section public notification of our definitions in this part apply? § 112.5 should be withdrawn, any decision to modify or revoke the The criteria and definitions in this officer or qualified employee of FDA variance granted to States or foreign part apply in determining whether a may issue an order to withdraw the countries in which similarly situated food is adulterated: exemption. persons are located. (a) Within the meaning of section (b) An FDA District Director in whose (b) We will consider submissions 402(a)(3) of the Federal Food, Drug, and district the farm is located (or, in the from affected States or foreign countries Cosmetic Act (21 U.S.C. 342(a)(3)) in case of a foreign farm, the Director of the and from other interested parties as that the food has been grown, harvested, Office of Compliance in the Center for follows: packed, or held under such conditions Food Safety and Applied Nutrition), or (1) We will consider requests for that it is unfit for food; or an FDA official senior to such Director, hearings by affected States or foreign (b) Within the meaning of section must approve an order to withdraw the countries under part 16 of this chapter. 402(a)(4) of the Federal Food, Drug, and exemption. (i) If FDA grants a hearing, we will (c) FDA must issue an order to Cosmetic Act in that the food has been provide the State or foreign country withdraw the exemption to the owner, prepared, packed, or held under with an opportunity to make an oral operator, or agent in charge of the farm. submission. We will provide notice on insanitary conditions whereby it may (d) FDA must issue an order to our Web site of the hearing, including have become contaminated with filth, or withdraw the exemption in writing, the time, date, and place of hearing. whereby it may have been rendered signed and dated by the officer or (ii) If more than one State or foreign injurious to health. The criteria and qualified employee of FDA who is country requests an informal hearing definitions in this part also apply in issuing the order. under part 16 of this chapter about our determining whether a food is in determination that a particular variance violation of section 361 of the Public § 112.203 What information must FDA should be modified or revoked, we may Health Service Act (42 U.S.C. 264). include in an order to withdraw a qualified exemption? consolidate such requests (for example, § 112.192 What is the result of a failure to An order to withdraw a qualified into a single hearing). comply with this part? (2) We will consider written exemption applicable to a farm under submissions submitted to the public The failure to comply with the § 112.5 must include the following docket from interested parties. requirements of this part, issued under information: (c) We will provide notice of our final section 419 of the Federal Food, Drug, (a) The date of the order; decision as follows: and Cosmetic Act (21 U.S.C. 350h), is a (b) The name, address and location of (1) On the basis of the administrative prohibited act under section 301(vv) of the farm; record, FDA will issue a written the Federal Food, Drug, and Cosmetic (c) A brief, general statement of the decision, as provided for under part 16 Act (21 U.S.C. 331(vv)). reasons for the order, including information relevant to: of this chapter. § 112.193 What are the provisions for (2) We will publish a notice of our (1) An active investigation of a coordination of education and foodborne illness outbreak that is decision in the Federal Register. The enforcement? effective date of the decision will be the directly linked to the farm; or date of publication of the notice. Under Section 419(b)(2)(A) of the (2) Conduct or conditions associated Federal Food, Drug, and Cosmetic Act with a farm that are material to the § 112.182 What are the permissible types (21 U.S.C. 350h(b)(2)(A)), FDA safety of the food that would otherwise of variances that may be granted? coordinates education and enforcement be covered produce grown, harvested, Examples of permissible types of activities by State, Territorial, tribal, and packed and held at such farm. variances include: local officials. (d) A statement that the farm must (a) Variance from the requirements, comply with subparts B through O of established in § 112.44(c), when Subpart R—Withdrawal of Qualified this part on the date that is 60 calendar agricultural water is used during Exemption days after the date of the order; growing operations for covered produce (e) The text of section 419(f) of the § 112.201 Under what circumstances can Federal Food, Drug, and Cosmetic Act (other than sprouts) using a direct water FDA withdraw a qualified exemption in application method. accordance with the requirements of (21 U.S.C. 350(f)) and of this subpart; (b) Variance from the process § 112.5? (f) A statement that any informal conditions, established in § 112.54(c)(1), hearing on an appeal of the order must for static composting; We may withdraw your qualified be conducted as a regulatory hearing (c) Variance from the process exemption under § 112.5: under part 16 of this chapter, with conditions, established in § 112.54(c)(2), (a) In the event of an active certain exceptions described in for turned composting; investigation of a foodborne illness § 112.208; (d) Variance from the minimum outbreak that is directly linked to your (g) The mailing address, telephone application interval, established in farm; or number, email address, and facsimile § 112.56(a)(1), for an untreated (b) If we determine that it is necessary number of the FDA district office and biological soil amendment of animal to protect the public health and prevent the name of the FDA District Director in origin; and or mitigate a foodborne illness outbreak whose district the farm is located (or for (e) Variance from the minimum based on conduct or conditions foreign farms, the same information for application interval, established in associated with your farm that are the Director of the Office of Compliance § 112.56(a)(4), for a biological soil material to the safety of the food that in the Center for Food Safety and amendment of animal origin treated by would otherwise be covered produce Applied Nutrition); and a composting process in accordance grown, harvested, packed or held at (h) The name and the title of the FDA with the requirements of § 112.54(c). your farm. representative who approved the order.

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§ 112.204 What must I do if I receive an agent in charge of the farm may include under this subpart. The presiding officer order to withdraw a qualified exemption a written request for an informal hearing must prepare a written report of the applicable to my farm? as provided in § 112.207. hearing. All written material presented The owner, operator, or agent in at the hearing will be attached to the charge of a farm that receives an order § 112.207 What is the procedure for requesting an informal hearing? report. The presiding officer must to withdraw a qualified exemption include as part of the report of the (a) If the owner, operator, or agent in applicable to that farm under § 112.5 hearing a finding on the credibility of charge of the farm appeals the order, the must either: witnesses (other than expert witnesses) owner, operator, or agent in charge of (a) Comply with applicable whenever credibility is a material issue, requirements of this part within 60 the farm: (1) May request an informal hearing; and must include a proposed decision, calendar days of the date of the order or, with a statement of reasons. The hearing if operations have ceased and will not and (2) Must submit any request for an participant may review and comment on resume within 60 calendar days, before informal hearing together with its the presiding officer’s report within 2 the beginning of operations in the next written appeal submitted in accordance calendar days of issuance of the report. growing season; or with § 112.206 within 10 calendar days The presiding officer will then issue the (b) Appeal the order within 10 of the date of the order. final decision. calendar days of the date of the order in (b) A request for an informal hearing (5) Section 16.80(a)(4) of this chapter accordance with the requirements of may be denied, in whole or in part, if does not apply to a regulatory hearing § 112.206. the presiding officer determines that no under this subpart. The presiding § 112.205 Can I appeal or request a genuine and substantial issue of officer’s report of the hearing and any hearing on an order to withdraw a qualified material fact has been raised by the comments on the report by the hearing exemption applicable to my farm? material submitted. If the presiding participant under § 112.208(c)(4) are (a) Submission of an appeal, officer determines that a hearing is not part of the administrative record. justified, a written notice of the including submission of a request for an (6) No party shall have the right, determination will be given to the informal hearing, will not operate to under § 16.119 of this chapter to owner, operator, or agent in charge of delay or stay any administrative action, petition the Commissioner of Food and the farm explaining the reason for the including enforcement action by FDA, Drugs for reconsideration or a stay of the denial. unless the Commissioner of Food and presiding officer’s final decision. Drugs, as a matter of discretion, § 112.208 What requirements are (7) If FDA grants a request for an determines that delay or a stay is in the applicable to an informal hearing? informal hearing on an appeal of an public interest. If the owner, operator or agent in order withdrawing an exemption, the (b) If the owner, operator, or agent in charge of the farm requests an informal hearing must be conducted as a charge of the farm appeals the order, hearing, and FDA grants the request: regulatory hearing under regulation in and FDA confirms the order, the owner, (a) The hearing will be held within 10 accordance with part 16 of this chapter, operator, or agent in charge of the farm calendar days after the date the appeal except that § 16.95(b) does not apply to must comply with applicable is filed or, if applicable, within a a hearing under this subpart. With requirements of this part within 60 timeframe agreed upon in writing by the respect to a regulatory hearing under calendar days of the date of the order, owner, operator, or agent in charge of this subpart, the administrative record or, if operations have ceased and will the farm and FDA. of the hearing specified in not resume within 60 calendar days, (b) The presiding officer may require §§ 16.80(a)(1), (a)(2), (a)(3), and (a)(5), before the beginning of operations in the that a hearing conducted under this and § 112.208(c)(5) constitutes the next growing season. subpart be completed within 1 calendar exclusive record for the presiding day, as appropriate. officer’s final decision. For purposes of § 112.206 What is the procedure for (c) FDA must conduct the hearing in submitting an appeal? judicial review under § 10.45 of this accordance with part 16 of this chapter, chapter, the record of the administrative (a) To appeal an order to withdraw a except that: qualified exemption applicable to a farm (1) The order withdrawing an proceeding consists of the record of the under § 112.5, the owner, operator, or exemption under § 112.5, rather than hearing and the presiding officer’s final agent in charge of the farm must: the notice under § 16.22(a) of this decision. (1) Submit the appeal in writing to the chapter, provides notice of opportunity § 112.209 Who is the presiding officer for FDA District Director in whose district for a hearing under this section and is an appeal and for an informal hearing? the farm is located (or in the case of a part of the administrative record of the foreign farm, the Director of the Office regulatory hearing under § 16.80(a) of The presiding officer for an appeal, of Compliance in the Center for Food this chapter. and for an informal hearing, must be an Safety and Applied Nutrition), at the (2) A request for a hearing under this FDA Regional Food and Drug Director mailing address, email address, or subpart must be addressed to the FDA or another FDA official senior to an FDA facsimile number identified in the order District Director (or, in the case of a District Director. within 10 calendar days of the date of foreign farm, the Director of the Office the order; and § 112.210 What is the timeframe for of Compliance in the Center for Food issuing a decision on an appeal? (2) Respond with particularity to the Safety and Applied Nutrition) as facts and issues contained in the order, provided in the order withdrawing an (a) If the owner, operator, or agent in including any supporting exemption. charge of a farm appeals the order documentation upon which the owner, (3) Section 112.209, rather than without requesting a hearing, the operator or agent in charge of the farm § 16.42(a) of this chapter, describes the presiding officer must issue a written relies. FDA employees who preside at hearings report that includes a final decision (b) In a written appeal of the order under this subpart. confirming or revoking the withdrawal withdrawing an exemption provided (4) Section 16.60(e) and (f) of this by the 10th calendar day after the under § 112.5, the owner, operator, or chapter does not apply to a hearing appeal is filed.

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(b) If the owner, operator, or agent in DEPARTMENT OF HEALTH AND Electronic Submissions charge of a farm appeals the order and HUMAN SERVICES Submit electronic comments in the requests an informal hearing: following way: Food and Drug Administration (1) If FDA grants the request for a • Federal eRulemaking Portal: http:// www.regulations.gov. Follow the hearing and the hearing is held, the 21 CFR Parts 1, 16, 106, 110, 114, 117, instructions for submitting comments. presiding officer must provide a 2 120, 123, 129, 179, and 211 calendar day opportunity for the hearing Written Submissions participants to review and submit [Docket No. FDA–2011–N–0920] comments on the report of the hearing Submit written submissions in the under § 112.208(c)(4), and must issue a following ways: • FAX: 301–827–6870. final decision within 10 calendar days RIN 0910–AG36 • Mail/Hand delivery/Courier (for after the hearing is held; or Current Good Manufacturing Practice paper or CD–ROM submissions): (2) If FDA denies the request for a and Hazard Analysis and Risk-Based Division of Dockets Management (HFA– hearing, the presiding officer must issue Preventive Controls for Human Food 305), Food and Drug Administration, a final decision on the appeal 5630 Fishers Lane, rm. 1061, Rockville, confirming or revoking the withdrawal AGENCY: Food and Drug Administration, MD 20852. within 10 calendar days after the date HHS. Instructions: All submissions received the appeal is filed. ACTION: Proposed rule. must include the Agency name and Docket No. for this rulemaking. All § 112.211 When is an order to withdraw a SUMMARY: The Food and Drug comments received may be posted qualified exemption applicable to a farm Administration (FDA) is proposing to without change to http:// revoked? amend its regulation for Current Good www.regulations.gov, including any Manufacturing Practice In personal information provided. For An order to withdraw a qualified Manufacturing, Packing, or Holding exemption applicable to a farm under additional information on submitting Human Food (CGMPs) to modernize it comments, see the ‘‘Comments’’ heading § 112.5 is revoked if: and to add requirements for domestic of the SUPPLEMENTARY INFORMATION (a) The owner, operator, or agent in and foreign facilities that are required to section of this document. charge of the farm appeals the order and register under the Federal Food, Drug, Docket: For access to the docket to requests an informal hearing, FDA and Cosmetic Act (the FD&C Act) to read background documents or grants the request for an informal establish and implement hazard comments received, go to http:// hearing, and the presiding officer does analysis and risk-based preventive www.regulations.gov and insert the not confirm the order within the 10 controls for human food. FDA also is docket number, found in brackets in the calendar days after the hearing, or issues proposing to revise certain definitions heading of this document, into the a decision revoking the order within in FDA’s current regulation for ‘‘Search’’ box and follow the prompts that time; or Registration of Food Facilities to clarify and/or go to the Division of Dockets the scope of the exemption from (b) The owner, operator, or agent in Management, 5630 Fishers Lane, rm. registration requirements provided by 1061, Rockville, MD 20852. charge of the farm appeals the order and the FD&C Act for ‘‘farms.’’ FDA is taking FOR FURTHER INFORMATION CONTACT: requests an informal hearing, FDA this action as part of its announced denies the request for an informal initiative to revisit the CGMPs since With regard to the proposed rule: Jenny hearing, and FDA does not confirm the they were last revised in 1986 and to Scott, Center for Food Safety and order within the 10 calendar days after implement new statutory provisions in Applied Nutrition (HFS–300), Food and the appeal is filed, or issues a decision the FD&C Act. The proposed rule is Drug Administration, 5100 Paint Branch revoking the order within that time; or intended to build a food safety system Pkwy., College Park, MD 20740, 240– 402–2166. (c) The owner, operator, or agent in for the future that makes modern, science-, and risk-based preventive With regard to the information charge of the farm appeals the order collection: Domini Bean, Office of without requesting an informal hearing, controls the norm across all sectors of the food system. Information Management, Food and and FDA does not confirm the order Drug Administration, 1350 Picard Dr., within the 10 calendar days after the DATES: Submit either electronic or PI50–400T, Rockville, MD 20850, appeal is filed, or issues a decision written comments on the proposed rule [email protected]. revoking the order within that time. by May 16, 2013. Submit comments on information collection issues under the SUPPLEMENTARY INFORMATION: (d) Confirmation of a withdrawal Paperwork Reduction Act of 1995 by Table of Contents order by the presiding officer is February 15, 2013, (see the ‘‘Paperwork considered a final Agency action for Reduction Act of 1995’’ section of this Executive Summary purposes of 5 U.S.C. 702. Purpose and Coverage of the Proposed Rule document). Summary of the Major Provisions of the Dated: January 3, 2013. ADDRESSES: You may submit comments, Proposed Rule Leslie Kux, identified by Docket No. FDA–2011–N– Costs and Benefits Assistant Commissioner for Policy. 0920 and/or RIN 0910–AG36, by any of I. Introduction II. Background [FR Doc. 2013–00123 Filed 1–4–13; 11:15 am] the following methods, except that comments on information collection A. Regulatory Framework for Human Food BILLING CODE 4160–01–P issues under the Paperwork Reduction B. FDA Food Safety Modernization Act C. Preventive Controls and Hazard Act of 1995 must be submitted to the Analysis and Critical Control Points Office of Regulatory Affairs, Office of (HACCP) Systems Management and Budget (OMB) (see the D. Food Safety Problems Associated With ‘‘Paperwork Reduction Act of 1995’’ Manufacturing, Processing, Packing, and section of this document). Holding Food for Human Consumption

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