# Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption > Briefs, arguments, decisions, and more. URL: https://www.frixlaw.com/law-library/documents/fr%3A2013-00123 ## Record - **Collection:** Federal Register - **Document type:** Proposed Rule - **Published:** January 16, 2013 - **Citation:** 78 FR 3504 ## Text DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Parts 16 and 112 [Docket No. FDA-2011-N-0921] RIN 0910-AG35 Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption AGENCY: Food and Drug Administration, HHS. ACTION: Proposed rule. SUMMARY: To minimize the risk of serious adverse health consequences or death from consumption of contaminated produce, the Food and Drug Administration (FDA) is proposing to establish science-based minimum standards for the safe growing, harvesting, packing, and holding of produce, meaning fruits and vegetables grown for human consumption. FDA is proposing these standards as part of our implementation of the FDA Food Safety Modernization Act (FSMA). These standards would not apply to produce that is rarely consumed raw, produce for personal or on-farm consumption, or produce that is not a raw agricultural commodity. In addition, produce that receives commercial processing that adequately reduces the presence of microorganisms of public health significance would be eligible for exemption from the requirements of this rule. The proposed rule would set forth procedures, processes, and practices that minimize the risk of serious adverse health consequences or death, including those reasonably necessary to prevent the introduction of known or reasonably foreseeable biological hazards into or onto produce and to provide reasonable assurances that the produce is not adulterated on account of such hazards. We expect that the proposed rule, if finalized as proposed, would reduce foodborne illness associated with the consumption of contaminated produce. DATES: Submit either electronic or written comments on the proposed rule by May 16, 2013. Submit comments on information collection issues under the Paperwork Reduction Act of 1995 by February 15, 2013 (see the “Paperwork Reduction Act of 1995” section of this document). ADDRESSES: You may submit comments, identified by Docket No. FDA-2011-N-0921 and/or Regulatory Information Number RIN 0910-AG35, by any of the following methods, except that comments on information collection issues under the Paperwork Reduction Act of 1995 must be submitted to the Office of Regulatory Affairs, Office of Management and Budget (OMB) (see the “Paperwork Reduction Act of 1995” section of this document). Electronic Submissions Submit electronic comments in the following way: • Federal eRulemaking Portal: http://www.regulations.gov . Follow the instructions for submitting comments. Written Submissions Submit written submissions in the following ways: • Mail/Hand delivery/Courier (for paper or CD-ROM submissions): Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Instructions: All submissions received must include the Agency name and Docket No. FDA-2011-N-0921 and Regulatory Information Number RIN 0910-AG35 for this rulemaking. All comments received may be posted without change to http://www.regulations.gov , including any personal information provided. For additional information on submitting comments, see the “Comments” heading of the SUPPLEMENTARY INFORMATION section of this document. Docket: For access to the docket to read background documents or comments received, go to http://www.regulations.gov and insert the docket number(s), found in brackets in the heading of this document, into the “Search” box and follow the prompts and/or go to the Division of Dockets Management, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT: Samir Assar, Center for Food Safety and Applied Nutrition (HFS-317), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, 240-402-1636. SUPPLEMENTARY INFORMATION: Table of Contents Executive Summary Proposed Rule I. Introduction A. Contamination With Microbiological Hazards B. Contamination With Chemical, Physical or Radiological Hazards II. Efforts To Address Produce Safety A. Inspections and Investigations B. Guidance Documents and Letters to Industry C. Produce Safety Action Plan D. Public Hearings E. Partnerships and Collaborations F. Current Industry Practices G. 2010 Federal Register Notice and Preliminary Stakeholder Comments H. White House Food Safety Working Group I. Other Related Issues III. Legal Authority A. Section 105 of FSMA and Section 419 of the FD&C Act B. Other Provisions of the FD&C Act C. The Public Health Service Act D. Legal Authority for Records Requirements E. Intrastate Activities F. Relevance of Section 415 of the FD&C Act to “Farm” Definition and Related Definitions IV. Regulatory Approach A. Qualitative Assessment of Risk B. Focus on Biological Hazards C. Consideration of Differing Risk of Different Commodities and Practices D. Framework of the Rule E. Records F. Farm-specific Food Safety Plans G. Foreign Farms H. Consistency With Codex Guidelines I. Product Testing as a Strategy to Control Pathogens J. Effective Dates K. Compliance Dates V. The Proposal A. Subpart A—General Provisions B. Subpart B—General Requirements C. Subpart C—Standards Directed to Personnel Qualifications and Training D. Subpart D—Standards Directed to Health and Hygiene E. Subpart E—Standards Directed to Agricultural Water F. Subpart F—Standards Directed to Biological Soil Amendments of Animal Origin and Human Waste G. Reserved H. Reserved I. Subpart I—Standards Directed to Domesticated and Wild Animals J. Reserved K. Subpart K—Standards Directed to Growing, Harvesting, Packing and Holding Activities L. Subpart L—Standards Directed to Equipment, Tools, Buildings, and Sanitation M. Subpart M—Standards Directed to Sprouts N. Subpart N—Analytical Methods O. Subpart O—Requirements Applying to Records That You Must Establish and Keep P. Subpart P—Variances Q. Subpart Q—Compliance and Enforcement R. Subpart R—Withdrawal of Qualified Exemption VI. Preliminary Regulatory Impact Analysis VII. Analysis Of Environmental Impact VIII. Federalism IX. Comments X. References Executive Summary The FDA Food Safety Modernization Act (FSMA) (Pub. L. 111-353) requires FDA to publish a notice of proposed rulemaking to establish science-based minimum standards for the safe production and harvesting of those types of fruits and vegetables that are raw agricultural commodities for which we have determined such standards minimize the risk of serious adverse health consequences or death. Further, new section 419 also requires FDA to adopt a final regulation based on known safety risks, setting forth procedures, processes, and practices that we determine to minimize the risk of serious adverse health consequences or death, including those that are reasonably necessary to prevent the introduction of known or reasonably foreseeable hazards into produce and to provide reasonable assurances that produce is not adulterated under section 402 of the FD&C Act. This proposed rule focuses on microbiological hazards related to produce growing, harvesting, packing, and holding. We conducted a “Draft Qualitative Assessment of Risk to Public Health from On-Farm Contamination of Produce” and considered the findings of this assessment in developing this proposed rule. While we acknowledge the potential for chemical, physical or radiological contamination of produce, for reasons discussed in this proposed rule, we are not proposing specific standards for these hazards in this rulemaking. Scope of Coverage of the Proposed Rule The proposed rule would apply to both domestic and imported produce. However, as explained in the remainder of this document, the proposed rule contains several exemptions: • The proposed rule would not apply to certain specified produce commodities that are rarely consumed raw. • The proposed rule also would not apply to produce that is used for personal or on-farm consumption, or that is not a raw agricultural commodity. • The proposed rule would provide an exemption for produce that receives commercial processing that adequately reduces the presence of microorganisms ( e.g. a “kill step”) as long as certain documentation is kept. • The proposed rule would not cover farms that have an average annual value of food sold during the previous three-year period of $25,000 or less. • The proposed rule would provide a qualified exemption and modified requirements for farms that meet two requirements: (1) The farm must have food sales averaging less than $500,000 per year during the last three years; and (2) the farm's sales to qualified end-users must exceed sales to others. A qualified end-user is either (a) the consumer of the food or (b) a restaurant or retail food establishment that is located in the same State as the farm or not more than 275 miles away. Instead, these farms would be required to include their name and complete business address either on the label of the produce that would otherwise be covered (if a label is required under the FD&C Act and its implementing regulations) or at the point-of-purchase. This exemption may be withdrawn in the event of an active investigation of an outbreak that is directly linked to the farm, or if it is necessary to protect the public health and prevent or mitigate an outbreak based on conduct or conditions on the farm that are material to the safety of the produce. As explained in the Preamble, these entities are either exempt from all the requirements of the rule or are subject to a narrower set of requirements. Summary of the Major Provisions of the Regulatory Action The proposed rule would establish science-based minimum standards for the safe growing, harvesting, packing, and holding of produce on farms. We propose new standards in the following major areas: • Worker Training and Heath and Hygiene ○ Establish qualification and training requirements for all personnel who handle (contact) covered produce or food-contact surfaces and their supervisors (proposed §§ 112.21, 112.22, and 112.23); ○ Require documentation of required training (proposed § 112.30); and ○ Establish hygienic practices and other measures needed to prevent persons, including visitors, from contaminating produce with microorganisms of public health significance (proposed §§ 112.31, 112.32, and 112.33). • Agricultural Water ○ Require that all agricultural water must be of safe and sanitary quality for its intended use (proposed § 112.41). Agricultural water is defined in part as water that is intended to, or likely to, contact the harvestable portion of covered produce or food-contact surfaces (proposed § 112.3(c)); ○ Establish requirements for inspection, maintenance, and follow-up actions related to the use of agricultural water, water sources, and water distribution systems associated with growing, harvesting, packing, and holding of covered produce (proposed §§ 112.42 and 112.46); ○ Require treatment of agricultural water if you know or have reason to believe that the water is not safe and of adequate sanitary quality for its intended use, including requirements for treating such water and monitoring its treatment (proposed § 112.43); ○ Establish specific requirements for the quality of agricultural water that is used for certain specified purposes, including provisions requiring periodic analytical testing of such water (with exemptions provided for use of public water supplies under certain specified conditions or treated water), and requiring certain actions to be taken when such water does not meet the quality standards (proposed §§ 112.44 and 112.45); and provide for alternative requirements for certain provisions under certain conditions (proposed § 112.12); and ○ Require certain records, including documentation of inspection findings, scientific data or information relied on to support the adequacy of water treatment methods, treatment monitoring results, water testing results, and scientific data or information relied on to support any permitted alternatives to requirements (proposed § 112.50). • Biological Soil Amendments ○ Establish requirements for determining the status of a biological soil amendment of animal origin as treated or untreated, and for their handling, conveying, and storing (proposed §§ 112.51, 112.52) ○ Prohibit the use of human waste for growing covered produce except in compliance with EPA regulations for such uses or equivalent regulatory requirements (proposed § 112.53); ○ Establish requirements for treatment of biological soil amendments of animal origin with scientifically valid, controlled, physical and/or chemical processes or composting processes that satisfy certain specific microbial standards (proposed §§ 112.54 and 112.55); and provide for alternative requirements for certain provisions under certain conditions (proposed § 112.12); ○ Establish application requirements and minimum application intervals for untreated and treated biological soil amendments of animal origin (proposed § 112.56); and provide for alternative requirements for certain provisions under certain conditions (proposed § 112.12); and ○ Require certain records, including documentation of application and harvest dates relevant to application intervals; documentation from suppliers of treated biological soil amendments of animal origin, periodic test results, and scientific data or information relied on to support any permitted alternatives to requirements (proposed § 112.60). • Domesticated and Wild Animals ○ If animals are allowed to graze or are used as working animals in fields where covered produce is grown and under the circumstances there is a reasonable probability that grazing or working animals will contaminate covered produce, require, at a minimum, an adequate waiting period between grazing and harvesting for covered produce in any growing area that was grazed, and measures to prevent the introduction of known or reasonably foreseeable hazards into or onto covered produce (proposed § 112.82); and ○ If under the circumstances there is a reasonable probability that animal intrusion will contaminate covered produce, require monitoring of those areas that are used for a covered activity for evidence of animal intrusion immediately prior to harvest and, as needed, during the growing season (proposed § 112.83). • Equipment, Tools, and Buildings ○ Establish requirements related to equipment and tools that contact covered produce and instruments and controls (including equipment used in transport), buildings, domesticated animals in and around fully-enclosed buildings, pest control, hand-washing and toilet facilities, sewage, trash, plumbing, and animal excreta (proposed §§ 112.121-134); and ○ Require certain records related to the date and method of cleaning and sanitizing equipment used in growing operations for sprouts, and in covered harvesting, packing, or holding activities (proposed § 112.140). • Sprouts ○ Establish measures that must be taken related to seeds or beans for sprouting (proposed § 112.141); ○ Establish measures that must be taken for the growing, harvesting, packing, and holding of sprouts (proposed § 112.142); ○ Require that you test the growing environment for Listeria spp. or L. monocytogenes and that you test each production batch of spent irrigation water or sprouts for E. coli O157:H7 and Salmonella species and take appropriate follow-up actions (proposed §§ 112.143, 112.144, 112.145, 112.146); and ○ Require certain records, including documentation of your treatment of seeds or beans for sprouting, a written environmental monitoring plan and sampling plan, test results, and certain methods used (proposed § 112.150). As proposed, the effective date is 60 days after a final rule is published, however, we are providing for a longer timeline for farms to come into compliance. Small businesses ( i.e., those subject to proposed part 112 and, on a rolling basis, the average annual monetary value of food sold during the previous three-year period is no more than $500,000) would have three years after the effective date to comply; for some of the water requirements, they would have five years. In addition, very small businesses ( i.e., those subject to proposed part 112 and, on a rolling basis, the average annual monetary value of food sold during the previous three-year period is no more than $250,000) would have four years after the effective date to comply; for some of the water requirements, they would have six years. All other farms would have two years after the effective date to comply; for some of the water requirements, they would have four years to comply. Costs and Benefits The baseline estimate for preventing all illnesses associated with microbial contamination of produce covered by this proposed regulation is $1.6 billion; however, we do not expect that we will eliminate all illnesses associated with covered produce. Instead, we expect that the proposed produce safety regulation will prevent some portion of this illness burden from recurring. We estimate the number of foodborne illness prevented by this regulation to be 1.75 million, with an associated benefit of $1.04 billion, annually. As described in the Preliminary Regulatory Impact Analysis (PRIA), making a precise estimate of the rule's likely effectiveness is extremely difficult, because FDA has only limited data that would establish a clear baseline estimate of how contamination occurs and the likely impact of the proposed provisions on that baseline, with respect to causing human illness. We estimate the costs of the proposed rule to be $459.56 million annually for domestic farms, $170.62 million annually for foreign farms covered by the rule (for a grand total of $630.18 million annually), resulting in $406.22 million annually in estimated potential net benefits. Summary of Costs and Benefits of the Proposed Rule 1 Prevented foodborne Illnesses (in millions) Total benefits (in millions) Total domestic costs (in millions) Total foreign costs (in millions) Total costs (domestic + foreign) Net benefits (in millions) Total 1.75 $1,036.40 $459.56 $170.62 $630.18 $406.22 Very small Small Large Average Annual Cost per Farm $4,697 $12,972 $30,566 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 contamination, and data related to current industry food safety practices. Proposed Rule I. Introduction Each year, about 48 million Americans (1 in 6) get sick, 128,000 are hospitalized, and 3,000 die from foodborne diseases, according to estimates from the Centers for Disease Control and Prevention. The FDA Food Safety Modernization Act (FSMA) (Pub. L. 111-353), signed into law by President Obama on January 4, 2011, enables FDA to better protect public health by helping to ensure the safety and security of the food supply. FSMA enables us to focus more on preventing food safety problems rather than primarily reacting to problems after they occur. The law also provides us with new enforcement authorities to help us achieve higher rates of compliance with prevention- and risk-based safety standards and to better respond to and contain problems when they do occur. In addition, the law gives us important new tools to better ensure the safety of imported foods and directs us to build an integrated national food safety system in partnership with State and local authorities. Section 105 of FSMA adds section 419 to the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 350h) requiring FDA to publish a notice of proposed rulemaking to establish science-based minimum standards for the safe production and harvesting of those types of fruits and vegetables that are raw agricultural commodities for which we have determined such standards are necessary to minimize the risk of serious adverse health consequences or death. Further, new section 419 also requires FDA to adopt a final regulation based on known safety risks, setting forth procedures, processes, and practices that we determine to minimize the risk of serious adverse health consequences or death, including those that are reasonably necessary to prevent the introduction of known or reasonably foreseeable hazards into produce and to provide reasonable assurances that produce is not adulterated under section 402 of the FD&C Act. This proposed rule sets forth such standards, as well as certain exemptions from the standards, consistent with section 419 of the FD&C Act. Two additional proposed rules, with the produce safety proposed rule, will be the foundation of, and central framework for, a new food safety system in the United States. In an accompanying notice in this issue of the Federal Register , FDA is publishing the preventive controls proposed rule that would apply to human food and require domestic and foreign facilities that are required to register under the FD&C Act to have written plans that identify hazards, specify the steps that will be put in place to minimize or prevent those hazards, monitor results, and act to correct problems that arise. FDA also intends to publish the foreign supplier verification program (FSVP) proposed rule, which would help ensure the safety of foods imported into the U.S. by making importers accountable for verifying that the food they import is produced using processes and procedures that achieve the same level of public health protection for imported food as required of domestic growers and processors under FSMA's new standards for produce safety and preventive controls. Eating fruits and vegetables is an important part of a healthy diet (Ref. 1). FDA is responsible for ensuring the safety of all domestic and imported fruits and vegetables consumed in the United States. We place a high priority on identifying and implementing measures that can reduce the incidence of foodborne illness associated with produce and maintain a high level of consumer confidence in this important food category. Produce is vulnerable to contamination with microorganisms of public health significance ( e.g., bacteria and viruses that can cause disease), as well as chemical, physical, and radiological contaminants. Contamination of produce can occur on-farm during growing (either in an open environment or in a fully- or partially-enclosed building), harvesting, packing, or holding; or elsewhere along the farm-to-table continuum. A. Contamination With Microbiological Hazards American consumers enjoy one of the safest supplies of produce in the world. Over the last few decades, however, problems linked to produce, including the associated public health implications, have been reported in a number of countries worldwide. Many factors affect the occurrence of microbial contamination of fresh produce, including worker health and hygiene, the quality of agricultural water, the use of animal manure and other materials of animal origin as fertilizer, the presence of wild or domestic animals in or near fields or packing areas, growing and harvesting operations, and equipment and building sanitation. As discussed in more detail below, FDA has taken several steps to help reduce the likelihood of microbial contamination; significant advances have been made. However, in spite of these efforts, produce-associated foodborne illnesses continue. FDA has looked specifically at outbreaks where the point of contamination is likely to have happened early in the production chain, during growing, harvesting, manufacturing, processing, packing, holding, or transportation (Ref. 2). Of the total reported outbreaks and outbreak-related illnesses linked to FDA-regulated foods between 1996 and 2010, in the FDA database, produce accounted for 23.3% and 42.3%, respectively. Both domestic produce and imported produce were identified as vehicles in these outbreaks. From 1996 to 2010, approximately 131 produce-related reported outbreaks occurred, resulting in 14,132 outbreak-related illnesses, 1,360 hospitalizations and 27 deaths. These outbreaks were associated with approximately 20 different fresh produce commodities (Ref. 3). Commodities associated with outbreaks during this time period included sprouts; leafy greens such as lettuce and spinach; tomatoes; melons such as cantaloupe and honeydew; berries such as raspberries, blueberries, blackberries, and strawberries; fresh herbs such as basil and parsley; and green onions as well as fresh-cut fruits and vegetables. FDA also has evidence that contamination occurs on some produce crops at least intermittently based on sampling performed as part of investigation, inspections, and FDA Domestic and Import Field Assignments and data from United States Department of Agriculture (USDA)'s Agricultural Marketing Service (AMS) Microbiological Database program (MDP) (Ref. 4 Ref. 5). For instance, in 2009, AMS tested eight types of produce for E. coli O157:H7, non-O157 E. coli carrying shiga toxin and enterotoxin genes, and Salmonella. MDP identified 51 samples with E. coli carrying shiga toxin genes; however only 24 of these were determined to be pathogenic. MDP identified 32 samples with Salmonella confirmed by culture. The USDA AMS MDP was discontinued in 2012 and FDA is evaluating options for any future collection of similar microbiological data. The following commodities accounted for 88.5% of the total produce-associated outbreaks: • 34 outbreaks associated with sprouts, • 30 outbreaks associated with leafy greens such as lettuce and spinach • 17 outbreaks associated with tomatoes • 14 outbreaks associated with melons such as cantaloupe and honeydew • 10 outbreaks associated with berries, such as raspberries, blueberries, blackberries and strawberries • 6 outbreaks associated with fresh herbs such as basil and parsley • 3 outbreaks associated with green onions. (Ref. 2) In the FDA database, fresh-cut fruits and vegetables accounted for 16.8% of the total produce-related outbreaks. Generally, the most likely point of original contamination for the fresh-cut-related outbreaks, as determined by FDA and its federal and state partners during the outbreak investigations, appears to be during growing, harvest, packing or holding, while the commodity is still in its raw agricultural commodity (RAC) form, rather than during manufacturing/processing of the fresh-cut product (Ref. 2). In a few instances, such as unwashed, field packed tomatoes being removed from a warm ripening room and placed in cold water to firm for slicing (which may have promoted infiltration of pathogens) (Ref. 6), it is possible that practices or conditions at the fresh-cut facility contributed to the contamination event. It is possible that the way product is handled during processing, including mixing large batches of fresh-cut product, may spread contamination across a larger volume of product, impacting the size and scope of an outbreak associated with fresh-cut produce. However, there have also been a number of very large outbreaks associated with RACs. Pathogens associated with the produce outbreaks include bacteria, viruses and parasites. Between 1996 and 2010, the majority of fresh produce-related outbreaks and illnesses in the FDA database were associated with bacterial agents (86.5%), followed by parasites (11.6%) and viruses (1.9%). These outbreaks involved a number of pathogens, including E. coli O157:H7, E. coli O157, Salmonella species ( Salmonella spp.), Listeria monocytogenes (L. monocytogenes), Cyclospora, Shigella sonnei, and Hepatitis A. In an accompanying document titled “Draft Qualitative Assessment of Risk to Public Health from On-Farm Contamination of Produce,” FDA has conducted a qualitative assessment of risk associated with growing, harvesting, packing, and holding of produce (hereafter referred to as the Qualitative Assessment of Risk (QAR)). In particular, the QAR is intended to address various risk management questions related to biological hazards of concern in fresh produce that can lead to serious adverse health consequences or death; potential routes of contamination; and the likelihood of contamination and likelihood of illness attributable to consumption among various types of produce commodities. The findings of this qualitative assessment of risk informed our regulatory approach and several proposed provisions. We provide a summary of the findings in section IV; additionally, we refer to the QAR throughout this proposed rule, including the discussion of proposed provisions in section V of this document. B. Contamination With Chemical, Physical or Radiological Hazards Chemical contaminants of produce can originate from a variety of sources. Most common among these include soil (through previous chemical exposure), equipment ( e.g., lubricants, fuels, and refrigerants), pesticides, insecticides and related agents, and cleaning compounds ( e.g., sanitizers) normally used in the course of maintaining buildings and equipment. FDA monitors chemical and pesticide residues in foods through its regulatory monitoring programs with emphasis on raw agricultural commodities (RACs) and foods consumed by infants and children. Illnesses attributable to chemical hazards are rare (Ref. 7). In fact, between 1997 and 2011, there have been no Class I recalls of produce associated with a chemical hazard for which there is a reasonable probability of causing serious health problems or death (Ref. 8). Current monitoring, regulations, and industry practice have been sufficient to keep these hazards under control. Similarly, the potential public health consequences of physical hazard contamination ( e.g. glass or metal fragments) in produce appear to be relatively (Ref. 7). Rarely do the physical hazards associated with produce suggest a risk of serious adverse health consequences or death for individuals that would consume the product. In fact, between 1997 and 2011, there have been no Class I recalls of produce associated with a physical hazard for which there is a reasonable probability of causing serious health problems or death (Ref. 8). The presence of radiological hazards in foods is a rare event and consumer exposure to harmful levels of radionuclide hazards, outside of catastrophic events, is very low (Ref. 7. Ref. 9). While we acknowledge the potential for chemical, physical or radiological contamination of produce, based on our analysis (Ref. 7), and for the reasons discussed in section IV.B of this document, we are not proposing specific standards for these hazards in this rulemaking. II. Efforts to Address Produce Safety FDA and others have taken a number of actions to address produce safety in the last two decades. This section describes several of these activities up to and including FSMA. A. Inspections and Investigations We have conducted a number of inspections and investigations that have provided useful information about the routes of contamination. Investigations involved visiting multiple field locations and packing operations. Observations during the investigations revealed several areas of farm practices that seem most likely to have been possible routes of contamination for produce involved in the outbreaks. Our inspections, investigations, and surveillance sampling activities are described in more detail in accompanying documents. B. Guidance Documents and Letters to Industry 1. GAPs Guide On October 2, 1997, President Clinton announced the “Initiative to Ensure the Safety of Imported and Domestic Fruits and Vegetables” (Produce and Imported Food Safety Initiative or PIFSI). As part of this initiative, the President directed the Secretary of the Department of Health and Human Services (HHS) and the Secretary of the U.S. Department of Agriculture (USDA), in cooperation with the agricultural community, to issue guidance on good agricultural practices (GAPs) for fresh fruits and vegetables. In October, 1998, we issued final guidance to industry entitled “Guide to Minimize Microbial Food Safety Hazards for Fresh Fruits and Vegetables” (GAPs Guide) (Ref. 10). This guide contains voluntary recommendations for good agricultural practices (GAPs) that growers and packers can undertake to address common factors contributing to contamination in their operations. The GAPs Guide is a broad scope guidance that takes into account the diversity of conditions and practices associated with the growing, harvesting, packing and holding of fresh produce. We noted that firms should use the general recommendations in the GAPs Guide to tailor practices to their individual operations. As the GAPs Guide notes, current technologies cannot eliminate all potential food safety hazards associated with fresh produce that will be eaten raw. Therefore, the focus of the GAPs Guide is on implementing measures to minimize the potential for introduction of such hazards. On September 2, 2008, we issued a notice in the Federal Register (73 FR 51306) requesting comments and scientific data and information to assist us in improving the GAPs Guide. We specifically asked for information about (1) current agricultural practices and conditions used to produce, harvest, pack, cool, and transport fresh produce; (2) risk factors for contamination of fresh produce associated with these practices; and (3) possible recommendations or additional measures that would enhance the safety of fresh produce. We also requested information about the estimated costs and benefits of current practices and/or the cost and benefits of any recommendations. We received approximately two dozen submissions from organizations and individuals, including: Industry, government, universities, environmental groups, consumers, and consumer groups. A number of comments discussed the value of performing operational assessments, developing food safety plans and record keeping but suggested that any updated guidance acknowledge that these activities should be commensurate with the complexity of an operation and associated risks. Other comments requested additional information on microbial testing to ensure that when testing is done it is meaningful and cost effective. 2. Letters to Lettuce, Tomato, and Cilantro Industries On February 5, 2004, we issued a letter to firms that grow, harvest, pack or hold fresh lettuce and fresh tomatoes, expressing concern regarding outbreaks of foodborne illness associated with the consumption of these products, and recommending actions to enhance the safety of these products (Ref. 11). On November 4, 2005, we issued a second letter to firms that grow, harvest, pack, hold or manufacture/process fresh and fresh-cut lettuce, reiterating concerns about continuing outbreaks (Ref. 12). In the November 2005 letter, we strongly encouraged applicable firms to review their current operations in light of the GAPs Guide, as well as other available information regarding the reduction or elimination of pathogens on fresh produce. We encouraged firms to consider modifying their operations to ensure that they were taking the appropriate measures to provide a safe product to the consumer. We recommended that firms from the farm level through the distribution level undertake these steps. In March, 2011, we issued a letter to firms that grow, harvest, pack or hold fresh cilantro, expressing concern about positive sample findings and recommending actions to enhance the safety of these products (Ref. 13). Between 2004 and March, 2011, there had been 28 confirmed Salmonella positive sample results in fresh cilantro in, or entering into, commerce. Samples were of both U.S. and imported origin. As with earlier letters to the industry, we strongly encouraged applicable firms to review their current operations in light of the GAPs Guide, as well as other available information regarding the reduction or elimination of pathogens on fresh produce. We encouraged firms to consider modifying their operations to ensure that they were taking the appropriate measures to provide a safe product to the consumer. In addition, we encouraged these firms to assess hazards unique to the production of cilantro and to develop commodity-specific preventive control strategies. We recommended that firms from the farm level through the distribution level undertake these steps. 3. Guidances and Letters Regarding Sprouts On October 27, 1999, we published a notice of availability (64 FR 57893) for two guidance documents to inform all parties involved in the production of sprouts ( i.e., producers, conditioners, and distributors of seeds and beans used for sprouting, sprout producers) that sprouts have been recognized as an important cause of foodborne illness and to provide recommendations for preventive controls that we believed should be taken immediately to reduce the likelihood of sprouts serving as a vehicle for foodborne illness (Ref. 14).(Ref. 15) The first guidance document, “Reducing Microbial Food Safety Hazards for Sprouted Seeds” (the Sprout Guide), provides recommendations based on the recommendations of the National Advisory Committee on Microbiological Criteria for Foods (NACMCF) (Ref. 16). We also released a second guidance, “Sampling and Microbial Testing of Spent Irrigation Water During Sprout Production” (the Sprout Testing Guide), to assist sprouters in implementing one of the principal recommendations in the broader Sprout Guide, i.e., that producers test spent irrigation water for two pathogens ( Salmonella spp. and E coli O157:H7) before product enters commerce. We refer to these guidances collectively as the Sprout Guides. On April 22, 2005, we announced in the Federal Register (70 FR 20852) a public meeting to elicit information on current science related to foodborne illness associated with the consumption of sprouts. The meeting notice contained a series of questions to help focus comments, including questions regarding: (1) Practices that may contribute to contamination of seeds used for sprouting and intervention strategies that could help prevent, reduce, or control contamination of seeds used for sprouting; (2) Whether the preventive controls recommended in our Sprout Guides could be improved and, if so, how this might be done; (3) What can or should be done to increase the involvement of producers of seeds for sprouting and seed distributors to ensure the safety of sprouts; (4) How, if at all, should the actions to improve the safety of seeds for sprouting be structured to take into account variation within the seed and sprout industry, including variations in size of establishments, the types of seeds and sprouts produced and the practices used in production; and (5) Existing food safety systems or standards (such as international standards) that we should consider as part of our efforts to minimize foodborne illness associated with the consumption of sprouts. In general, comments expressed a need to include the seed industry, as well as the sprout industry, in efforts to improve the safety of sprouts. Several comments stated that any recommendations should be scientifically sound, based on appropriate (and feasible) expectations for risk reduction, and be easy to understand and implement. Comments expressed concern about the effect on worker health of treating seed with 20,000 ppm calcium hypochlorite. Comments were generally supportive of recommendations in the Sprout Guides to test spent irrigation water; several comments supported expanded testing, including seed testing by seed producers and distributors. All but one comment maintained that seeds were the primary source of contamination in sprout-associated outbreaks. Several comments discussed practices and conditions, such as animal grazing, which could contaminate seed in the field. One comment suggested the industry develop a GAPs guidance specific to the production of seed for use in sprouts. Several comments supported applying Current Good Manufacturing Practices (CGMPs) (21 CFR Part 110) to sprout facilities. A number of comments cited the diversity of sprout types currently being produced and noted this diversity of products is likely to continue to grow. These comments maintained it was therefore appropriate to provide flexibility for individual operations to select mitigations appropriate for the products they produce. Comments to the 2005 Sprout Public Meeting were considered in this rulemaking and will be further described when we discuss proposed provisions specific to sprouts in section V.M. of this document. On May 1, 2009, we issued a letter to suppliers and distributors of seeds and beans used for sprouting, and sprouters, to make firms aware of our serious concerns with continuing outbreaks associated with the consumption of raw and lightly cooked sprouts and to urge firms to review their operations in light of our Sprout Guides and other available information (Ref. 17), and to modify their operations accordingly to ensure they are taking appropriate measures to provide a safe product to consumers. We also shared a May 1, 2008, letter from the California Department of Public Health (CDPH) to the California sprout industry outlining several critical areas of concern identified in recent investigations and CDPH recommendations for controlling hazards associated with those observations (Ref. 18). 4. Draft Commodity Specific Guidances On August 3, 2009, we published a notice in the Federal Register announcing the availability for public comment of draft commodity specific guidances (CSGs) for melons (74 FR 38437), tomatoes (74 FR 38438) and leafy greens (74 FR 38439). The draft CSGs are intended for growers, packers, processors, transporters, retailers, and others throughout the supply chain. The draft CSGs, if finalized, would provide a framework for identifying and implementing appropriate measures to minimize the likelihood of microbial contamination of tomatoes, leafy greens, and melons. The draft CSGs reflect both commodity specific information, such as recommendations for tomato repacking, and advances in collective thinking in broader areas, such as assessing potential hazards in and near the field before beginning production and immediately before harvest, and protecting and maintaining water quality at its source and during distribution and use. The draft CSGs are designed to complement our GAPs Guide and Fresh-cut Guide. On November 4, 2009, we published a notice in the Federal Register , extending to January 4, 2010, the comment period on the draft CSGs. We have not yet issued these guidances in final form. In developing the draft CSGs, we relied heavily on existing industry commodity specific guidelines, our produce safety initiatives and programs, lessons learned from outbreak investigations, and other public and private programs. We have since received several dozen written comments, from industry, States, and individuals. Comments were generally supportive of the scope and objectives of the draft CSGs. Comments provided their views on both commodity specific issues ( e.g., recommendations for field packing tomatoes, water quality for rehydrating leafy greens after harvest) and cross-cutting issues ( e.g., management of wild animal intrusion, quality of water used in postharvest operations). A number of comments requested that we recognize different risks may be associated with different commodities within the commodity groups covered by the CSGs, noting, for example, that cantaloupe (not watermelon) have been identified as the vehicle in the majority of foodborne illness outbreaks associated with melons. A number of comments expressed concern about potential bias of the CSG approach ( i.e., separate recommendations for different commodities) against small farms growing a diversity of crops, especially the concern that the CSG approach could require such farms to have multiple food safety plans to cover each of the commodities they grow. Additional comments will be discussed when we describe proposed provisions relevant to those comments. 5. Guidances Regarding Nuts On March 11, 2009, we published a notice in the Federal Register (74 FR 10598) announcing the availability for public comment of draft guidance for industry: Measures to Address the Risk for Contamination by Salmonella Species in Food Containing a Peanut-Derived Product as an Ingredient. Additionally, on June 29, 2009, we published a notice in the Federal Register (74 FR 310308) announcing the availability for public comment of draft guidance for industry: Measures to Address the Risk for Contamination by Salmonella Species in Food Containing a Pistachio-Derived Product As An Ingredient. These draft guidance documents were intended for manufacturers who use a peanut-derived product or pistachio-derived product as an ingredient in a food product. These draft guidances provide recommendations for evaluating the effectiveness of certain Salmonella control measures. We have not yet issued these guidances in final form. 6. Fresh-cut Guide On March 6, 2006, we published a notice in the Federal Register (71 FR 11209) announcing the availability on our Web site of a draft Guidance for Industry entitled “Guide to Minimize Microbial Food Safety Hazards of Fresh-cut Fruits and Vegetables” (the Fresh-cut Guide). We received a number of comments from trade associations, consumer groups, and industry. Comments were generally supportive of the draft Guide. A few comments included questions about our draft definition of fresh-cut produce and whether the recommendations in the draft guidance were mandatory or voluntary, in light of the mandatory requirements in existing CGMPs. On February 25, 2008, we published a notice (73 FR 10037) announcing our finalization and the availability of our “Guide to Minimize Microbial Food Safety Hazards of Fresh-cut Fruits and Vegetables” (the Fresh-cut Guide). The Fresh-cut Guidance complements the CGMPs in 21 CFR, Part 110 and provides recommendations for a framework for identifying and implementing appropriate measures to minimize the likelihood of microbial contamination during the processing of fresh-cut produce. Examples of recommendations for fresh-cut processors in the Fresh-cut Guidance include: (1) Know your suppliers and have a mechanism to verify that your suppliers use good agricultural practices, good manufacturing practices, and other appropriate food safety practices; and (2) ensure equipment is designed to prevent water collection. While fresh-cut produce is not covered under the scope of this proposed rule, we include a reference to our guidance on fresh-cut produce as some of the measures recommended in that document are relevant to the requirements proposed for covered produce in this rule. B. Produce Safety Action Plan On June 15, 2004, we published a Federal Register notice (69 FR 33393) announcing a public meeting to elicit information from stakeholders concerning key elements of a draft produce safety action plan entitled “Produce Safety From Production to Consumption: An Action Plan to Minimize Foodborne Illness Associated With Fresh Produce” (the Produce Safety Action Plan or PSAP). We posted the draft PSAP on June 18, 2004 (Ref. 19). The draft PSAP continued the 1997 Produce and Imported Food Safety Initiative, building on experience from earlier efforts such as the development and implementation of the GAPs Guide, inspections of farms and produce packing facilities, surveillance sampling assignments, and investigations of foodborne illness outbreaks. The draft PSAP addressed all principal points between the farm and table where contamination of produce could occur. It covered fresh fruit and vegetables in their native (RAC) form and raw, minimally processed products ( i.e., fresh-cut produce) that have received some processing to alter their form but have not been subject to a thermal process that would eliminate microbial hazards. The draft PSAP was not intended to cover processed products such as juice, or agricultural products other than fruits and vegetables. After considering comments received from various stakeholders, in October 2004, we issued the final PSAP. In recognition that contamination of produce can happen at any point in the supply chain, the PSAP expands on the areas covered by the GAPs Guide ( i.e., farms and packing houses) to extend to all parts of the food supply chain from farm through retail or consumer preparation and consumption. The PSAP does not cover frozen fruits and vegetables, fruit and vegetable juices, or nuts. The PSAP has four main objectives: (1) Prevent contamination of fresh produce with pathogens; (2) minimize the public health impact when contamination of fresh produce occurs; (3) improve communication with producers, packers, processors, transporters, distributors, preparers, consumers, and other government entities about the safety of fresh produce; and (4) facilitate and support research relevant to the contamination of fresh produce. For each objective, the PSAP identifies steps or actions that could contribute to the achievement of that objective. The PSAP has measurable goals and outcomes, and several steps outlined in the PSAP are already in progress or have been completed. For example, we issued the Fresh-cut Guide and provided technical assistance to industry efforts to develop commodity specific supply chain guidance as part of the PSAP objective regarding prevention of contamination. C. Public Hearings On February, 27, 2007, we published a notice (72 FR 8750) of two public hearings, and request for comment, on the safety of fresh produce. In that notice, we stated that we believe that the measures outlined in the PSAP, the GAPs Guide, and other public and private sector actions, when implemented, can be effective in reducing the likelihood of microbial contamination of fresh produce. However, the fact that outbreaks of foodborne illness associated with fresh produce continue to occur supports the need for a close examination of: The extent to which these measures have been implemented; whether they have been effective when implemented properly; and, what additional or different interventions might be appropriate to reduce the likelihood of future outbreaks. We held the public hearings to share information about recent outbreaks of foodborne illness associated with microbial contamination of fresh produce, and to invite comments, data, and other scientific information about: Current practices used to grow, harvest, pack, hold, manufacture/process, and transport fresh produce; risk factors for contamination of fresh produce associated with these practices; and measures FDA could take to enhance the safety of fresh produce. The notice of hearings included a list of issues and questions to help focus comments and asked for scientific information and data. We received approximately 48 submissions from industry, government, universities, environmental groups, consumers, and consumer groups. Recurring comments included: The importance of activities to promote or enhance rapid, accurate traceback; strengthened coordination and communication between all sectors ( i.e., researchers, regulators, and industry) on available science and current unpublished data; and an integrated, multidisciplinary approach to identify best practices not currently incorporated by industry. A number of comments expressed concerns about the cost of third party audits and lack of standardization of such audits. Comments also indicated a desire for training. Comments were divided on whether we should continue to promote adoption of voluntary GAPs guidance or pursue rulemaking to establish mandatory requirements. Comments supporting mandatory requirements differed on what these requirements should look like; suggestions ranged from mandatory GAPs to a Hazard Analysis and Critical Control Point (HACCP)-like approach, or a combination of the two. Comments were in general agreement that, whatever regulatory approach was chosen, it should be consistent across the United States, based on sound science, and cover a broad range of commodities while being flexible enough to accommodate the needs of specific commodities, regions, operations, practices, and different sizes of operations. D. Partnerships and Collaborations 1. Public and Private Standards Because the GAPs Guide is voluntary, FDA and food safety partners in the public and private sectors have emphasized education and outreach to industry to promote adoption of the guidance. Buyer requirements that producers and other suppliers provide self- or third party audit verification that they are following the GAPs Guide have further promoted adoption of the guidance. We have worked with the fresh produce industry since the release of the GAPs Guide to promote its recommendations and to advance the scientific knowledge applicable to enhancing the safety of fresh produce. For example, in conjunction with the PSAP, we have provided technical assistance to industry in developing several industry commodity specific guidelines that cover the entire supply chain, including commodity-specific guidelines for melons, leafy greens, tomatoes, and green onions; these commodities together accounted for 70 percent of the foodborne outbreaks associated with produce between 1998 and 2009 (Ref. 3). These industry guidelines were in turn helpful to us in developing FDA's draft commodity specific guidances for the same commodities (see section II.B.4 of this document). Additional industry guidelines have been developed or are in progress for a broad range of commodities, including: strawberries, mushrooms, watermelon, potatoes, storage onions, and citrus. We provided technical assistance to the Association of Food and Drug Officials (AFDO) to formulate a Model Code of Practice for the Production of Fresh Fruits and Vegetables (the Model Code) (Ref. 20). This work grew out of a request from the tomato industry in late 2006 to address outbreaks of foodborne illness attributed to fresh tomatoes. However, the AFDO Board believed that it was also important to address GAPs in the production of a broader range of fresh fruits and vegetables. Thus, AFDO convened a working group to develop a Model Code for produce safety during growing, harvesting, packing and holding that could be considered as a model for guidance and/or regulation by Federal and State regulatory bodies, and for collaboration among such parties and the industry. The Model Code does not address the additional processing steps that may occur at a fresh-cut or other processing facility, which is covered by the CGMPs in 21 CFR part 110. The Model Code focuses on minimizing the potential for contamination of fresh produce with pathogens. Through cooperative agreement with Cornell University, FDA has, together with USDA AMS, established a jointly funded Produce Safety Alliance (PSA), based on the successful Seafood HACCP Alliance for Training and Education. The PSA is a public-private partnership that will develop and disseminate science- and risk-based training and education programs to provide produce farms with fundamental food safety knowledge, starting in advance of this proposed rule and continuing after the final rule is promulgated. The PSA includes active participation from the produce industry and academic institutions nationwide. The curriculum development process has already started, through establishment of topic-specific working committees charged with identifying challenges to understanding and implementing GAPs on farms. This first phase of work, in advance of a final rule, is intended to assist farms, especially small farms, in establishing appropriate food safety measures, consistent with the GAPs Guide and other existing guidances, so that they will be better positioned when we issue a final rule establishing produce safety standards under section 419 of the FD&C Act. As this rulemaking progresses, the PSA materials will be modified, as needed, to be consistent with the requirements in the rule. 2. Foodborne Illness Investigations—Environmental Assessment Model An “environmental assessment,” in the foodborne illness outbreak or food contamination setting, means an investigation that is triggered by an outbreak of foodborne illness or food contamination incident with the purpose of determining how the environment may have contributed to the introduction or transmission of pathogens or other hazards that caused illness or contamination. In addition to our more traditional investigational team approach, during this process we work collaboratively with a number of experts from CDC, State and local agencies, and industry. In 2010, we conducted an environmental assessment in response to a foodborne illness outbreak involving 33 cases of STEC O145 infection in 5 States. While we have not made a definitive determination regarding how or at what point in the supply chain E. coli O145 contamination occurred, this assessment was important in a number of respects. As mentioned above, we worked collaboratively with a number of experts from CDC, State and local agencies, and industry. Working with this team, we assessed potential sources of E. coli O145 not just in the field of interest, but in the larger growing area surrounding the field of interest, along with the potential for E. coli O145 to be transported from a source in the surrounding area to the field where implicated lettuce was grown. This highly collaborative, systems-based approach allowed for the discovery of important environmental risk factors that would not typically be explored by conventional investigation methods (Ref. 21). On December 29, 2010, we posted a report, entitled “Environmental Assessment: Non-O157 Shiga Toxin-Producing E. coli (STEC): Findings and Potential Preventive Control Strategies” (Ref. 21), outlining the environmental assessment approach used in this investigation, our observations and tentative conclusions. In 2011, we conducted an environmental assessment in response to a foodborne illness outbreak involving a total of 139 persons infected with any of four outbreak-associated strains of L. monocytogenes, including 29 deaths, in 28 States (as of November 1, 2011). On October 19, 2011, we posted a report, entitled “Environmental Assessment: Factors Potentially Contributing to the Contamination of Fresh Whole Cantaloupe Implicated in a Multi-State Outbreak of Listeriosis,” providing an overview of the assessment process, potential contributing factors in this outbreak, and recommended measures firms should employ to prevent similar contamination ( http://www.fda.gov/Food/FoodSafety/FoodborneIllness/ucm276247.htm ). As discussed further in sections III.F and V.A.2.b.i of this document, this proposed rule would not apply to off-farm packing facilities such as the packing facility associated with this cantaloupe outbreak—such facilities would instead be subject to existing part 110 and section 418 of the FD&C Act. However, we include the findings of this environmental assessment here because the contributing factors are relevant to both on-farm and off-farm produce packing practices. 3. Produce Safety Initiative Assessments In August 2006 we launched the Leafy Greens Safety Initiative (LGSI), a multi-year initiative which involved assessments of practices and conditions at select leafy greens farms and facilities in California (Ref. 22). In the summer of 2007, we began a multi-year Tomato Safety Initiative (TSI) to assess practices and conditions associated with growing and packing tomatoes on the Eastern Shore of Virginia, followed by assessments in three tomato growing areas in Florida (Ref. 23). The initiatives were conducted as part of a strategy to reduce foodborne illness by focusing food safety efforts on specific products, practices, and growing areas that have been identified in past outbreak investigations. The initiatives were a collaborative effort between FDA and the State health and agriculture departments in California, Virginia, and Florida, in cooperation with several universities and members of the produce industry. Both initiatives contained several important components, the most visible of which was a series of assignments to the field to assess conditions and practices at farms and packing houses that could lead to contamination and to observe actions taken by growers and packers in response to these conditions. Other important components of the initiatives included continuing communication and outreach with the industry at all points along the supply chain, facilitating and promoting research to enhance leafy green and tomato safety, and strengthening collaboration between Federal, State, and local public health officials in disease detection and response. Assessments of tomato packing facilities covered dump tank water quality parameters, employee hygiene, and facility cleaning and sanitation practices. Assessments of the farms addressed irrigation water sources (such as ponds and wells), source water and procedures for mixing crop chemicals, the potential impacts of weather events, such as drought and flooding, and animal proximity to growing fields. Assessments were scheduled to coincide with tomato production and harvest seasons on the Eastern Shore of Virginia and in three tomato producing regions in Florida. Where the teams observed conditions or practices at one or more locations that might be improved, they shared those observations directly with the individual firm and also shared observations in general terms at a post-assessment meeting so that all interested parties could apply the findings to their operations. For example, we identified issues related to proximity of portable toilets to irrigating ponds and harvesting of drops at one or more locations. The teams recommended that portable toilets should be distanced from the irrigation pond and policies that forbid the harvesting of drops should be strictly enforced. We also shared preliminary observations through other venues, including a tomato research priorities meeting in College Park (hosted by Joint Institute for Food Safety and Applied Nutrition (JIFSAN) and the University of Florida's Institute of Food and Agricultural Sciences) (JIFSAN 2010 (update)), a Leafy Greens Research Needs workshop hosted by United Fresh in Herndon, VA (United Fresh 2008), and as technical assistance to public and private efforts to develop new or enhanced guidances. 4. Research FDA researchers have focused on refining or developing methods to detect, isolate and subtype pathogens of concern in produce, to enhance our ability to analyze samples in support of our compliance activities. As resources permit, FDA scientists also directly investigate questions about factors contributing to produce contamination. We also supported extramural research and collaborations with other Federal agencies, academic institutions, and industry-supported entities to leverage research efforts, expertise, and resources (such as experimental stations for field research). This includes successful collaborations with USDA on research of mutual interest. To fill knowledge gaps, thus facilitating implementation of any new policies, we have initiated new agreements with USDA to conduct research in key areas such as agricultural water and soil amendments (Ref. 24). Specifically, FDA has provided approximately one million dollars to sponsor research at USDA ARS and to develop a produce safety rule research network at the Western Center for Food Safety at University of California Davis. We intend these collaborative efforts to result in the collection of data that may help resolve questions about the necessary time between application of raw manure or contaminated water and safe harvest of produce in key agro-ecological growing conditions and for key crops. Our goal is for this research to result in suggested protocols that farms could follow in compliance with a final produce rule, and for this process to be duplicated for other crops and regions as further funding is secured. This FDA sponsored research was initiated to demonstrate the commitment of federal agencies to address the needs of farmers, to provide initial data to finalize study protocols for further research, and to attract matching funds from industry. In partnership with academic institutions across the country, FDA has also created four Centers of Excellence (CoE), each housed at a university and charged with specific food-safety tasks (Ref. 25). In 2008, a 5-year cooperative agreement was awarded to the University of California, Davis (UC Davis) to establish the most recent of these CoEs, the Western Center for Food Safety (WCFS). Through this agreement, FDA has been able to leverage the resources and expertise of UC Davis to study the impact of the unique geography and ecology of the growing regions of the Western United States. 5. Engagement With Other Federal Agencies FDA regularly consults and coordinates with other Federal agencies in the area of produce safety. Examples of these efforts can be found throughout this document and include collecting samples, sharing data, providing training and technical assistance to industry, and research. Our partnerships with USDA and CDC have been particularly valuable to our efforts. 6. Engagement with Industry and Academia We regularly engage with experts in the produce industry and in academia. These engagements serve to both educate the industry about our thinking, activities, and expectations, and to educate us about current industry practices and academic efforts to enhance the safety of produce. In addition to the collaborations mentioned above, we initiated multiple produce industry listening sessions across the country prior to the passage of FSMA. At these sessions, we provided local industry and academia an opportunity to ask questions and voice concerns about the potential for legislation impacting the produce industry. We visited a total of 13 States with significant produce production in 2010. FDA and USDA technical experts, scientists and managers participated in these meetings, and we were able to tour large and smaller scale farms, and talk to people with practical experience in production and implementing food safety programs on farms. We also were involved with the Produce Safety Project (PSP), a research and advocacy organization based at Georgetown University and funded by the Pew Charitable Trust. The PSP provided four issue briefs (Ref. 26.Ref. 27.Ref. 28.Ref. 29) each focused on specific aspects of produce production, the risks they may represent, prevention and mitigation strategies to address these risks, and further research needs in the area. Further, PSP held 6 regional stakeholder discussion sessions to elicit comment and reaction from the produce industry, and to offer an avenue to speak directly to the documents' authors. A common message from the industry during these discussions was concern about food safety and a desire to know how to reduce risks. Small growers and packers in particular conveyed a need for information and technical support that would assist them in implementing food safety practices. E. Current Industry Practices In response to foodborne illnesses associated with produce in the mid 1990s, the produce industry developed produce safety guidance, engaged in outreach regarding produce safety best practices, developed compliance auditing programs, and funded produce safety research. 1. Industry Produce Safety Best Practices Guidance In 1997, the International Fresh-cut Produce Association and the Western Growers Association published Voluntary Food Safety Guidelines for Fresh Produce, which provided generalized voluntary industry guidelines to minimize the potential for contamination for fresh produce in growing, packing, shipping and processing operations. After FDA issued our GAPs Guide, industry developed commodity specific guidances for various produce industry segments including: Commodity Specific Food Safety Guidelines for the Melon Supply Chain (2005), Commodity Specific Food Safety Guidelines for the Lettuce and Leafy Greens Supply Chain (2006), Commodity Specific Food Safety Guidelines for the Fresh Tomato Supply Chain (2006 1st Edition, 2008 2nd edition) and Commodity Specific Food Safety Guidelines for the Production, Harvest, Post-Harvest, and Valued-Added Unit Operations of Green Onions (2010). In addition, other industry segments including, but not limited to mushrooms, strawberries, watermelons, citrus, avocados, almonds, and dry bulb onions developed commodity specific guidances. The fresh-cut produce industry, via the International Fresh Produce Association, published in 1992 Food Safety Guidelines for the Fresh-cut Produce Industry and updated this publication periodically, with the 4th edition being published most recently in 2001. 2. Produce Industry Food Safety Compliance Auditing Shortly after the FDA GAPs Guide was finalized, a number of retail produce buyers informed suppliers that as a condition of sale, their produce suppliers must follow, and be third party audited for conformance with, the FDA GAPs guide (Ref. 30). In 1999 USDA AMS began developing a GAPs and Good Handling Practices (GAP & GHP) Audit Verification Program, in response to requests from growers and the Association of Fruit and Vegetable Inspection and Standardization Agencies. The program, based on the GAPs Guide, was piloted in 2000 and fully available later that same year. In September 2001 the United Fresh Fruit and Vegetable Association published guidance entitled Food Safety Auditing Guidelines: Core Elements of Good Agricultural Practices for Fresh Fruits and Vegetables to provide the basis for GAPs audits in the produce industry. In 2011 the United Fresh Produce Association published a Harmonized GAPs Standard for use by producers and third party auditors in the fresh produce industry. In 2007 leafy greens growers in California, with the assistance of the USDA AMS and CDFA, developed and implemented the California Leafy Greens Marketing Agreement (CA LGMA) (Ref. 31). The objective of the CA LGMA is to protect public health via compliance with the food safety practices accepted by the LGMA board, verified through mandatory government audits of members and signatories to the agreement by CDFA auditors trained and licensed by USDA AMS (Ref. 31). In 2007 leafy greens growers in Arizona also adopted a similar marketing agreement and audit structure for their growers (Ref. 32). At the request of industry, the USDA AMS in 2009 held seven hearings throughout the United States to solicit input from the leafy greens industries across the U.S. regarding their desire to develop a proposed national marketing agreement for leafy greens (74 FR 45565). A decision regarding the proposed USDA AMS national marketing agreement for leafy greens is currently pending. In 2007, the Florida Legislature passed a law that provided the Department of Agriculture and Consumer Services with the authority to address safety concerns related to fresh tomatoes. Implementing regulations which became effective on July 1, 2008 (Florida Tomato Inspection Regulation 5G-6, 2007) adopted and incorporated by reference almost all of the recommendations in the Commodity Specific Food Safety Guidelines for the Fresh Tomato Supply Chain, 2nd Edition (July 2008). GAPs implementation and GAPs audits have now become common components of purchase specifications for produce in some market segments, and have been a significant force in increasing awareness of GAPs and promoting their implementation (Ref. 33). However, growers and packers who sell product through direct marketing channels, or to buyers who do not include GAPs as a condition of sale, may be less familiar with GAPs. 3. Produce Industry Produce Safety Education Outreach In addition to participation in the PSA housed at Cornell University (discussed above in section II.D. of this document), the produce industry promoted adoption and implementation of the recommendations in the FDA GAPs Guide through education and outreach efforts in cooperation with the land grant universities. The National GAPs Program at Cornell University, with collaborators at other land grant universities, developed a series of publications to train domestic growers and packers on the key principles of produce safety, including: Food Safety Begins on the Farm: A Grower's Guide (2000); Food Safety Begins on the Farm: A Grower Self Assessment of Food Safety Risks (2003); and, Fruits, Vegetables, and Food Safety: Health and Hygiene on the Farm (2004). These publications and others developed by land grant universities throughout the United States have been used to train the produce industry on produce safety best practices. F. 2010 Federal Register Notice and Preliminary Stakeholder Comments On February 23, 2010, we published in the Federal Register (75 FR 8086; 2010 FR notice) a notice opening a docket to obtain information about current practices and conditions for the production and packing of fresh produce. On May 20, 2010, we extended the original 90-day comment period for the docket until July 23, 2010 (75 FR 28263). We established this docket to provide an opportunity for interested parties to provide information and share views that would inform the development of (1) safety standards for fresh produce at the farm and packing house and (2) strategies and cooperative efforts to ensure compliance. In particular, we welcomed input on these general categories: (1) Role of the good agricultural practice recommendations in the GAPs Guide; (2) Standards for domestic and foreign growers and packers; (3) Identification and prioritization of risk factors; (4) Environmental assessment of hazards and possible pathways of contamination; (5) The impact of scale/size of growing operations on the nature and degree of possible food safety hazards; (6) Methods to tailor preventive controls to particular hazards and conditions affecting an operation; (7) Possible approaches to tailoring preventive controls to the scale of an operation so that the controls achieve an appropriate level of food safety protection and are feasible for a wide range of large and small operations; (8) Coordination of produce food safety practices and sustainable and/or organic production methods; (9) Coordination of produce food safety practices and environmental and/or conservation goals or practices; (10) Coordination of produce food safety practices and Federal, state, local and tribal government statutes and regulations; (11) Microbial testing; (12) Postharvest operations and the role of the CGMPs in 21 CFR part 110; (13) Records and other documentation that would be useful to industry and regulators in ensuring the safety of fresh produce; and (14) Strategies to enhance compliance. We further advised that information previously submitted to the dockets requesting comments on the draft commodity-specific guidances (CSGs), or to the docket requesting comments and scientific data and information to update the GAPs Guide, would be considered in this rulemaking and need not be resubmitted. Comments submitted to these dockets, i.e., dockets on the GAPs Guide update and draft CSGs, as well as comments at the Sprouts Public Meeting and Produce Safety Hearings, are discussed in sections II.B. and II.D. of this document. In response to the 2010 FR notice, we received about 880 comments from consumers, farmers and producers, industry groups and trade associations, consumer groups, environmental groups, academia, retail establishments, packers and handlers, food markets and coops, laboratories and public health facilities, and federal, state, local and foreign governments. The USDA Agricultural Marketing Service (AMS) submitted a record of their public hearings related to their proposed voluntary national marketing agreement for leafy green vegetables (NLGMA) (74 FR 45565, September 3, 2009 and 74 FR 48423, September 23, 2009), and requested that we consider the contents of that record (which included testimony, exhibits, and written arguments or briefs based on evidence received at the public hearing) in our deliberations to develop safety standards for fresh produce. A summary of general comments received is presented in this section while specific comments relevant to the issues addressed in this proposed rule are discussed in sections V.C through V.R of this document. 1. Comments on Impact, Flexibility and Transparency Overall, a majority of stakeholders, including farmers, producers, consumers and industry, expressed concern about the scope and impact of regulation on the livelihoods of those who produce food and on their ability to produce food in an economically-feasible manner. Most comments supported a food safety system, grounded in science, for the production of produce in a fair and equitable manner for both domestic and imports. Comments noted that regulations developed should be science-based and provide for producers to manage risks in a manner appropriate to their operations. Several comments maintained that risk assessments, hazard assessments, operational assessments and development of food safety plans are vital tools for farmers to be able to demonstrate that the food safety practices they employ are effective. Conversely, others questioned the need for some industry segments, such as small farms or growers of “low risk” commodities to establish food safety plans. A majority of comments also stated that research is needed on various issues relevant to produce safety, including water quality, soil amendments, animals (both wildlife and domesticated), and worker health and hygiene. Comments urged the agency to tailor regulations to reflect variables such as farm size, markets served, growing conditions, and risk. In addition, comments highlighted the importance of transparency in the development and implementation of food safety standards, and expressed that transparency provides regulators, buyers, and the public with the confidence they need to ensure that all reasonable and required practices have been put in place and that any specific producer or packer of produce is in compliance with required food safety practices. FSMA directs us to establish science-based minimum standards for produce safety. These standards are to include procedures, processes, and practices that we determine to be reasonably necessary to prevent the introduction of known or reasonably foreseeable biological, chemical, and physical hazards into covered produce and to provide reasonable assurances that produce is not adulterated under section 402 of the FD&C Act. As discussed in section IV below, FDA intends to adopt a regulatory approach that considers the risk posed by both the commodity and relevant agronomic practices, and provides the most appropriate balance between public health protection and flexibility. We recognize the need to incorporate appropriate flexibility within regulations to reflect the diversity of commodities and associated processes, practices, and conditions covered within the scope of this rule. For example, exemptions based on monetary value of food sold by the farm and direct farm marketing, commercial processing of commodities, and other criteria are reflected in proposed subpart A. Under certain specified conditions, qualified exemptions and associated modified requirements in a calendar year are also provided under proposed subpart A. In addition, proposed § 112.12 would establish a framework for alternatives to certain requirements of the rule. We realize that numerous differences exist among practices based on risk or agro-ecological conditions and therefore alternatives to certain requirements would be permitted when adequate and documented scientific data or information support such alternatives. Similarly, proposed subpart P sets procedures for a State or foreign country to request a variance from one or more requirements of this part when certain conditions are met, as required by Section 419(c)(2) of the FD&C Act. For example, a State or foreign country may consider that the historical performance of an industry within their jurisdiction ( e.g., as indicated by the epidemiological record) and the combination of measures taken by that industry merits requesting a variance from some or all provisions of this proposed rule. In requesting a variance, among other things, the State or foreign country would submit information that, while the procedures, processes and practices to be followed under the variance would be different from those prescribed in this proposed rule, the requested variance is reasonably likely to ensure that the produce is not adulterated under section 402 of the FD&C Act and provide the same level of public health protection as the requirements of the final regulations (see proposed 112.173). FDA would encourage consideration of these kinds of submissions. Furthermore, in addition to soliciting comments on the proposed regulation through this notice, we will be holding public meetings in diverse geographic areas of the United States to provide persons in different regions an opportunity to comment, as required under Section 419(a)(2) of the FD&C Act. 2. Comments on Environmental Considerations Several comments pointed out that there are a number of state and federal laws and programs that relate to environmental stewardship, and noted that environmental conservation and food safety are not necessarily cross-competing goals. Comments favored a uniform regulatory approach among Federal, State, local and tribal governments' statutes and regulations, and recommended that we consider the work of other Federal agencies, including the Environmental Protection Agency, the Department of Agriculture, and the Department of the Interior in developing proposed requirements for produce to ensure such requirements do not unnecessarily inhibit co-management of food safety and environmental concerns. In this regard, a few comments stated that while co-management of food safety and sustainability may be considered, ultimately, food safety has to be top priority and it is unacceptable to sell unsafe food to customers. Section 419(a)(3)(D) of the FD&C Act directs that this proposed rule take into consideration, consistent with ensuring enforceable public health protection, conservation and environmental practice standards and policies established by Federal natural resource conservation, wildlife conservation, and environmental agencies. As discussed further in Sections III.A.8 and V.I, we consulted with several Federal agencies in order to take into consideration conservation and environmental practice standards and policies established by those agencies. FDA also plans to work closely with Federal, State, and local agencies in implementing the final rule. 3. Comments on Guidance and Education A majority of comments also expressed the need for guidance to assist stakeholders in implementing the requirements established in final regulations. Moreover, several comments stressed the importance of educational programs and incentives in any effective food safety system. Section 419(e) of the FD&C Act requires FDA to publish updated good agricultural practices and guidance for the safe production and harvesting of specific types of fresh produce, in consultation with the Secretary of Agriculture, representatives of State departments of agriculture, farmer representatives, and various types of entities engaged in the production and harvesting or importing of fruits and vegetables that are raw agricultural commodities, including small businesses. In addition, section 419(e) of the FD&C Act requires FDA to conduct education and outreach regarding this guidance through public meetings in diverse geographical regions. FDA intends to provide ample opportunity for public consultation and input and will strive to develop stronger partnerships with the private sector to ensure optimal use of resources. 4. Comments Related to Foreign Producers A number of foreign governments expressed concerns with the foreign producers' ability to comply with and FDA's enforcement of the regulation, stressing the need for transparency. Some comments requested we consider convergence with existing private schemes, such as the Global Food Safety Initiative and Global G.A.P to avoid duplication of efforts while others urged us to consider recognition of foreign governments' produce safety initiatives. In implementing a final rule based on this proposed rule, we intend to provide equal treatment in the application, compliance, and enforcement of the proposed standards for foreign and domestic facilities. Recognizing that foreign farms in some countries may have difficulty in understanding the rule's applicability to them, we will partner with stakeholders to identify areas for outreach and technical cooperation to achieve greater understanding of the proposed provisions. Furthermore, consistent with section 419(c)(2) of the FD&C Act, in proposed subpart P, we establish a procedure whereby a State or foreign country could request a variance from one or more requirements proposed in the rule, where the State or foreign country determines that (1) the variance is necessary in light of local growing conditions; and (2) the procedures, processes, and practices to be followed under the variance are reasonably likely to ensure that the produce is not adulterated under section 402 of the FD&C Act, and to provide the same level of public health protection as the requirements of this rule (see section V.P. of this document). G. White House Food Safety Working Group In 2009, President Obama established a White House Food Safety Working Group to identify measures needed to upgrade our food safety laws for the 21st Century, coordinate Federal efforts, and develop short- and long-term agendas to make food safer. Specific objectives of this workgroup included: Fostering coordination of food safety efforts throughout the government and ensuring laws are being adequately enforced to keep the American people safe from foodborne illness. The workgroup was co-chaired by the Secretaries of the HHS and USDA. Participating agencies included FDA, USDA's Food Safety and Inspection Service (FSIS), CDC, the Department of Homeland Security, the Department of Commerce, the Department of State, EPA, and several offices of the White House. On July 7, 2009, the workgroup released its report “Implementing a National Public Health Approach to Food Safety: Report to the President.” This report included recommendations for a new public health-focused approach to the safety of all food based on three core principles: (1) Prioritizing prevention, (2) strengthening surveillance and enforcement, and (3) improving response and recovery. Workgroup recommendations and White House directives specific to produce included (1) issuing commodity-specific guidances to reduce the likelihood of microbial contamination in the production and distribution of tomatoes, melons, and leafy greens; and (2) taking steps (including seeking public comment) to establish required practices through regulation. The numerous steps we have taken in response to these directives are described throughout this section. H. Other Related Issues 1. Tracking and Tracing of Produce Our regulations in 21 CFR part 1, subpart J require that persons who manufacture, process, pack, transport, distribute, receive, hold, or import food in the United States establish and maintain records identifying the immediate previous sources and immediate subsequent recipients of food. During an outbreak of foodborne illness, these records can help determine the source of the food implicated in the outbreak. Farms are excluded from the requirements of part 1, subpart J. We recently held public meetings to stimulate and focus a discussion about mechanisms to enhance product tracing systems for food in general (74 FR 56843; November 3, 2009) and for produce in particular (73 FR 55115; September 24, 2008). Section 204 of FSMA now directs us to take a variety of different actions that will enhance our ability to track and trace foods, including to establish pilot projects to explore and evaluate methods to rapidly and effectively identify recipients of food to prevent or control a foodborne illness outbreak. Further efforts to enhance the tracking and tracing of food are outside of the scope of this proposed rule. 2. Transportation of Food On April 30, 2010 (75 FR 22713), we published in the Federal Register an Advance Notice of Proposed Rulemaking (ANPRM) as a first step in implementing the Sanitary Food Transportation Act of 2005 (SFTA). SFTA requires the Secretary of HHS to issue regulations setting forth sanitary transportation practices to be followed by shippers, carriers by motor vehicle or rail vehicle, receivers, and others engaged in food transport. Section 111 of FSMA directs us to promulgate regulations to implement SFTA. We intend to focus our efforts directed to sanitary transportation practices as a separate rulemaking, already underway under the ANPRM. However, such efforts are outside of the scope of this proposed rule. III. Legal Authority FDA is proposing this regulation under the FD&C Act as amended by FSMA, and the Public Health Service Act (PHS Act). A. Section 105 of FSMA and Section 419 of the FD&C Act On January 4, 2011, the FDA Food Safety Modernization Act (FSMA) (Pub. L. 111-353) was signed into law. Section 105 of FSMA, Standards for Produce Safety, among other things, amends the FD&C Act to create a new section 419 with the same name. Section 419(a)(1)(A) of the FD&C Act directs the Secretary of HHS, “in coordination with the Secretary of Agriculture and representatives of State departments of agriculture (including with regard to the national organic program established under the Organic Foods Production Act of 1990), and in consultation with the Secretary of Homeland Security,” to “publish a notice of proposed rulemaking to establish science-based minimum standards for the safe production and harvesting of those types of fruits and vegetables, including specific mixes or categories of fruits and vegetables, that are raw agricultural commodities for which the Secretary has determined that such standards minimize the risk of serious adverse health consequences or death.” In addition to this broad direction in section 419(a)(1)(A), section 419(a)(3) establishes more specific requirements for the content of the proposed rule, including that the proposed rule: • “[P]rovide sufficient flexibility to be applicable to various types of entities engaged in the production and harvesting of fruits and vegetables that are raw agricultural commodities, including small businesses and entities that sell directly to consumers, and be appropriate to the scale and diversity of the production and harvesting of such commodities” (section 419(a)(3)(A)); • “[I]nclude, with respect to growing, harvesting, sorting, packing, and storage operations, science-based minimum standards related to soil amendments, hygiene, packaging, temperature controls, animals in the growing area, and water” (section 419(a)(3)(B)); • “[C]onsider hazards that occur naturally, may be unintentionally introduced, or may be intentionally introduced, including by acts of terrorism” (section 419(a)(3)(C)); • “[T]ake into consideration, consistent with ensuring enforceable public health protection, conservation and environmental practice standards and policies established by Federal natural resource conservation, wildlife conservation, and environmental agencies” (section 419(a)(3)(D)); • “[I]n the case of production that is certified organic, not include any requirements that conflict with or duplicate the requirements of the national organic program established under the Organic Foods Production Act of 1990, while providing the same level of public health protection as the requirements under guidance documents, including guidance documents regarding action levels, and regulations under the FDA Food Safety Modernization Act” (section 419(a)(3)(E)); and • “[D]efine, for purposes of [section 419], the terms `small business' and `very small business'” (section 419(a)(3)(F)). Furthermore, section 419(b) of the FD&C Act establishes additional requirements that the final regulation: • “[P]rovide for minimum science-based standards for those types of fruits and vegetables, including specific mixes or categories of fruits and vegetables, that are raw agricultural commodities, based on known safety risks, which may include a history of foodborne illness outbreaks” (section 419(b)(1)); • “[P]rovide for coordination of education and enforcement activities by State and local officials, as designated by the Governors of the respective States or the appropriate elected State official as recognized by State statute” (section 419(b)(2)(A)); and • “[I]nclude a description of the variance process under [section 419(c)] and the types of permissible variances the Secretary may grant” (section 419(b)(2)(B)). In section 419(c), the FD&C Act establishes criteria for the final regulation, including that the final regulation: • “[S]et forth those procedures, processes, and practices that the Secretary determines to minimize the risk of serious adverse health consequences or death, including procedures, processes, and practices that the Secretary determines to be reasonably necessary to prevent the introduction of known or reasonably foreseeable biological, chemical, and physical hazards, including hazards that occur naturally, may be unintentionally introduced, or may be intentionally introduced, including by acts of terrorism, into fruits and vegetables, including specific mixes or categories of fruits and vegetables, that are raw agricultural commodities and to provide reasonable assurances that the produce is not adulterated under section 402” (section 419(c)(1)(A)); • “[P]rovide sufficient flexibility to be practicable for all sizes and types of businesses, including small businesses such as a small food processing facility co-located on a farm” (section 419(c)(1)(B)); • “[C]omply with chapter 35 of title 44, United States Code (commonly known as the `Paperwork Reduction Act'), with special attention to minimizing the burden (as defined in section 3502(2) of such Act) on the business, and collection of information (as defined in section 3502(3) of such Act), associated with such regulations” (section 419(c)(1)(C)); • “[A]cknowledge differences in risk and minimize, as appropriate, the number of separate standards that apply to separate foods” (section 419(c)(1)(D)); • “[N]ot require a business to hire a consultant or other third party to identify, implement, certify, compliance with these procedures, processes, and practices, except in the case of negotiated enforcement resolutions that may require such a consultant or third party” (section 419(c)(1)(E); • “[P]ermit States and foreign countries from which food is imported into the United States to request from the Secretary variances from the requirements of the regulations, subject to [section 419(c)(2) of the FD&C Act], where the State or foreign country determines that the variance is necessary in light of local growing conditions and that the procedures, processes, and practices to be followed under the variance are reasonably likely to ensure that the produce is not adulterated under section 402 [of the FD&C Act] and to provide the same level of public health protection as the requirements of the regulations adopted under [section 419(b) of the FD&C Act]” (section 419(c)(1)(F)); and • Establish requirements relating to variances, including that: ○ “A State or foreign country from which food is imported into the United States may in writing request a variance from the Secretary. Such request shall describe the variance requested and present information demonstrating that the variance does not increase the likelihood that the food for which the variance is requested will be adulterated under section 402, and that the variance provides the same level of public health protection as the requirements of the regulations adopted under [section 419(b) of the FD&C Act]. The Secretary shall review such requests in a reasonable timeframe” (section 419(c)(2)(A)). ○ “The Secretary may approve a variance in whole or in part, as appropriate, and may specify the scope of applicability of a variance to other similarly situated persons” (section 419(c)(2)(B)). ○ “The Secretary may deny a variance request if the Secretary determines that such variance is not reasonably likely to ensure that the food is not adulterated under section 402 and is not reasonably likely to provide the same level of public health protection as the requirements of the regulation adopted under [section 419(b) of the FD&C Act]. The Secretary shall notify the person requesting such variance of the reasons for the denial” (section 419(c)(2)(C)). ○ “The Secretary, after notice and an opportunity for a hearing, may modify or revoke a variance if the Secretary determines that such variance is not reasonably likely to ensure that the food is not adulterated under section 402 and is not reasonably likely to provide the same level of public health protection as the requirements of the regulations adopted under [section 419(b) of the FD&C Act]” (section 419(c)(2)(D)). In addition, section 105(c) of FSMA creates a new section 301(vv) in the FD&C Act (21 U.S.C. 331(vv)) to prohibit “[t]he failure to comply with the requirements under section 419 [of the FD&C Act].” 1. Coordination and Consultation Requirements Consistent with section 419(a)(1)(A) of the FD&C Act, FDA has coordinated with the Secretary of Agriculture and representatives of State departments of agriculture (Ref. 34. Ref. 35) and consulted with the Secretary of Homeland Security regarding this proposed rule. 2. Definitions of Small and Very Small Businesses Section 419(a)(3)(F) of the FD&C Act requires that the regulations define the terms “small business” and “very small business.” These terms are significant because section 419 of FSMA contains provisions specific to such entities. • “With respect to small and very small businesses* * * that produce and harvest those types of fruits and vegetables that are raw agricultural commodities that the Secretary has determined are low risk and do not present a risk of serious adverse health consequences or death, the Secretary may determine not to include production and harvesting of such fruits and vegetables in such rulemaking, or may modify the applicable requirements of regulations promulgated pursuant to [section 419]” (section 419(a)(1)(B) of the FD&C Act). • “[T]he regulations promulgated under [section 419 of the FD&C Act] shall apply to a small business* * * after the date that is 1 year after the effective date of the final regulation* * * [and] to a very small business* * * after the date that is 2 years after the effective date of the final regulation” (section 419(b)(3) of the FD&C Act). In section V.A. of this document, we discuss our proposed definitions of small and very small business. In section IV.K. of this document, we discuss our proposal to establish compliance dates for small and very small businesses that are three and four years, respectively, after the effective date of the final regulation, with additional, more extended compliance dates for certain proposed provisions related to water. FDA has tentatively decided not to exempt or modify the requirements of the proposed rule with respect to small and very small businesses that produce and harvest certain types of produce based on a determination that such types of produce are low risk and do not present a risk of serious adverse health consequences or death using the discretionary authority provided by section 419(a)(1)(B). It is not necessary to use this discretionary authority in part because, as discussed in section V.A. of this document, FDA proposes in § 112.2 to exclude certain types of low risk produce from the coverage of this rule without regard to the business size of the farm producing and harvesting such produce. As discussed in section IV.C.2. of this document, these exclusions are based on our tentative conclusion that science-based minimum standards to minimize the risk of serious adverse health consequences or death from biological hazards in these commodities are not warranted. Another reason it is not necessary to use the discretionary authority in section 419(a)(1)(B) is because, as discussed in section V.A. of this document, FDA proposes in § 112.4 to apply this regulation only to businesses with an average annual monetary value of food sold during the previous three-year period of more than $25,000 on a rolling basis, based on a tentative conclusion that businesses with $25,000 or less in sales do not contribute significantly to the produce market (1.5% of covered produce acres) and, therefore, to the volume of production that could become contaminated. Accordingly, we tentatively conclude that imposing the proposed requirements on these businesses is not warranted because it would have little measurable public health impact. We note that such farms would continue to be subject to the applicable requirements of the FD&C Act. 3. Exemptions and Exceptions Section 419(f)(1) of the FD&C Act establishes an exemption from the requirements under section 419 based on average annual monetary value of the food sold directly to “qualified end-users” (as defined in section 419(f)(4)) as compared to all other buyers and average annual monetary value of all food sold. Section 419(f)(2) establishes requirements for consumer notifications with respect to food from exempt farms, and section 419(f)(3) provides that the Secretary may withdraw the exemption in specified circumstances. In sections V.A and V.R of this document, we discuss proposed §§ 112.5 and 112.6, and subpart R, respectively, which would implement these provisions of the FD&C Act. Section 419(g) of the FD&C Act states “[t]his section shall not apply to produce that is produced by an individual for personal consumption.” In section V.A. of this document, we discuss proposed § 112.2(a)(2), which would implement this provision. Section 419(h) of the FD&C Act states “[t]his section shall not apply to activities of a facility that are subject to section 418.” In sections III.F and V.A.2.b.i of this document we discuss proposed § 112.4(a), which would implement this provision. 4. Intentional Adulteration FDA proposes to implement section 105 of FSMA in two regulations, rather than a single regulation that covers all hazards relevant to produce. This rulemaking is not intended to address hazards “that may be intentionally introduced, including by acts of terrorism.” (§ 419(a)(3)(C) and (c)(1)(A) of the FD&C Act). FDA plans to implement section 105 of FSMA regarding such hazards in a separate rulemaking in the future, and intends to consult with the Secretary of Homeland Security in that rulemaking, as required by § 419(a)(1)(A) of the FD&C Act. FDA tentatively concludes that intentional hazards likely will require different kinds of controls and would be best addressed in a separate rulemaking. 5. Science-Based Minimum Standards Related to Specific Topics Consistent with the provisions in Section 419(a)(3)(B) of the FD&C Act that requires us to establish “science-based minimum standards related to soil amendments, hygiene, packaging, temperature controls, animals in the growing area, and water,” this proposed rule addresses specific topics relevant to production and harvesting of produce on farms. We address standards related to soil amendments in subpart F; standards for hygiene in subpart D, standards for animals in the growing area in subpart I; and standards for water in subpart E. We address packaging as part of our proposed standards for harvest, packing, and holding activities in subpart K; and temperature controls as part of our proposed standards for agricultural water in subpart E. 6. Providing Sufficient Flexibility To Be Practicable As required by section 419(a)(3)(A) and (c)(1)(B), this proposed rule would provide sufficient flexibility to be practicable for all sizes and types of entities engaged in the production and harvesting of fruits and vegetables that are raw agricultural commodities, including small businesses and entities that sell directly to consumers, and is appropriate to the scale and diversity of the production and harvesting of such commodities. As discussed in section IV of this document, we have chosen a regulatory approach that provides significant flexibility. We propose a variety of different types of measures (including GMP-type measures, numerical standards, requirements to monitor and take action under certain circumstances, and written plans) to tailor the requirements of the proposed rule appropriately and to be practical for the diversity of farms and commodities that would be covered by the proposed rule. Wherever possible, we have also attempted to fashion this regulation to be as flexible as possible to accommodate future changes in science and technology and the particularities of local growing conditions and commodities. As discussed in section V.B of this document, in proposed § 112.12, we list the specific requirements established in this rule for which we would allow alternatives to be established and used in appropriate circumstances. This provision would provide significant flexibility by allowing individual farms to develop alternative standards suitable to their operations with appropriate scientific support. In addition, consistent with sections 419(c)(1)(F) and (c)(2) of the FD&C Act, in proposed subpart P, we provide for a mechanism by which a State or a foreign country from which food is imported into the United States may request a variance from one or more requirements proposed in this part, where the State or foreign country determines that: (a) The variance is necessary in light of local growing conditions; and (b) the procedures, processes, and practices to be followed under the variance are reasonably likely to ensure that the produce is not adulterated under Section 402 of the Act and to provide the same level of public health protection as the requirements of this part. Proposed subpart P would provide additional flexibility for alternative practices to be used where appropriate to specific local growing conditions and commodities. 7. Use of Third Parties In accordance with section 419(c)(1)(E) of the FD&C Act, we are not proposing to require a farm to hire a consultant or third party to identify, implement, certify, or comply with these produce safety standards. These standards are intended to be capable of implementation by those who engage in routine activities on the farm. As discussed in section II.D.1 and V.Q., FDA has, together with USDA AMS, established a jointly funded Produce Safety Alliance (PSA), a public-private partnership that will develop and disseminate science- and risk-based training and education programs to provide produce farms with fundamental food safety knowledge. Education and outreach through mechanisms like PSA and other sources of information that are familiar to the produce farming community (such as Cooperative Extension, land grant universities and trade associations) is the foundation of our intended compliance strategy. Through these mechanisms, FDA aims to assist farmers in gaining the food safety knowledge they will need to comply with the provisions of a final produce safety rule. 8. Consideration of Environmental Standards As required by section 419(a)(3)(D), in developing these produce safety standards and consistent with ensuring enforceable public health protection, we took into consideration conservation and environmental practice standards and policies established by Federal natural resource conservation, wildlife conservation, and environmental agencies. In developing this rule, we consulted with USDA's National Organic Program and Natural Resources Conservation Service, U.S. Fish and Wildlife Service, and the EPA to take into consideration conservation and environmental practice standards and policies established by those agencies (Ref. 34). Our proposed requirements encourage the application of practices that can enhance food safety, including sustainable conservation practices. Additionally, as discussed in section V.E of this document, this proposed rule is designed to be compatible with existing conservation practices in the management of agricultural water systems. Moreover, as discussed in section V.I of this document, this proposed rule would not require the destruction of habitat or the clearing of farm borders around outdoor growing areas or drainages. 9. Consistency With National Organic Program In accordance with section 419(a)(3)(E), this proposed rule does not include any requirements that conflict with or duplicate the requirements of the National Organic Program. In developing this proposed rule, we consulted with technical experts and representatives from the National Organic Program (Ref. 34). Compliance with the provisions of this proposed rule would not preclude compliance with the requirements for organic certification in 7 CFR part 205. Moreover, where this proposed rule and the National Organic Program would include similar or related requirements, we propose that our requirements may be satisfied concurrently with those of the National Organic Program ( i.e., to the extent the requirements are the same, compliance with this proposed rule could be achieved without duplication). For example, proposed § 112.54(c) would establish multiple options for composting processes used to treat biological soil amendments of animal origin used to grow covered produce, including two options (§ 112.54(c)(1) and (2)) that are consistent with the options available to USDA-certified organic farms under the National Organic Program regulations in 7 CFR 205.203(c)(2). As another example, the National Organic Program application intervals for the use of raw manure as a soil amendment in 7 CFR 205.203(c)(1) are 90 days and 120 days before harvest, depending on whether the edible portion of the crop contacts the soil. Proposed § 112.56(a)(1)(i) would require a 9 month application interval for use of raw manure in the growing of covered produce when application is performed in a manner that does not contact covered produce during application and minimizes the potential for contact with covered produce after application. Proposed § 112.56(a)(1)(ii) would not require an application interval for use of raw manure in the growing of covered produce when application is performed in a manner that does not contact covered produce during or after application. For certified organic farms growing produce that would be subject to this rule, the National Organic Program application intervals would run concurrently with the proposed application interval in this proposed rule, rather than consecutively. Organic farms (like other farms) using raw manure would either need to wait 9 months between application and harvest and use application methods meeting the proposed requirements for avoiding and minimizing contact between covered produce and raw manure, or apply the raw manure in a manner that does not contact covered produce during or after application. Doing so would not jeopardize their compliance with the requirements of the National Organic Program. In addition, this proposed rule would establish in proposed § 112.163 that records kept for other purposes could be used to satisfy the recordkeeping requirements in this proposed rule. Accordingly, records kept under 7 CFR 205.103 for the purposes of the National Organic Program that contain information that would be required in records under this proposed rule would not need to be duplicated. Further, while not critical to our conclusion regarding compliance with section 419(a)(3)(E) of the FD&C Act, we note that the provisions of the proposed rule are not in conflict with or duplicative of the non-binding recommendations of the National Organic Standards Board's Compost Tea Task Force (Ref. 36). Certified organic farms would be able to comply with the provisions of this proposed rule with respect to their use of agricultural teas while simultaneously meeting or exceeding the non-binding recommendations in the NOSB Compost Tea Task Force Report. We seek comment on our approach to ensuring that this proposed rule does not conflict with or duplicate the requirements of the National Organic Program while providing the same level of public health protection as required under FSMA. 10. Minimizing PRA burden In implementing section 419 of the FD&C Act through this proposed rule, FDA has complied with chapter 35 of title 44, United States code (commonly known as the “Paperwork Reduction Act” (PRA)), with special attention to minimizing the burden (as defined in section 3502(2) of such Act (44 U.S.C. 3502(2)) on the facility, and collection of information (as defined in section 3502(3) of such Act (44 U.S.C. 3502(3)), associated with the proposed rule. Under section 3502(2) of the PRA, “burden” means the “time, effort, or financial resources expended by persons to generate, maintain, or provide information to or for a Federal agency.” Under section 3502(3) of the PRA, “collection of information” means, in relevant part, “the obtaining, causing to be obtained, soliciting, or requiring the disclosure to third parties or the public, of facts or opinions by or for an agency, regardless of form or format, calling for * * * answers to identical questions posed to, or identical reporting or recordkeeping requirements imposed on, ten or more persons.* * *” In section X of this document, we discuss how this proposed rule complies with the requirements of the PRA. In addition, in implementing section 419 of the FD&C Act, we have paid special attention to minimizing burden and collection of information associated with this proposed rule. As discussed above, we are proposing requirements that provide significant flexibility for different sizes and types of farms. By making these requirements flexible enough to be practicable for different sizes and types of farms, the proposed rule also avoids creating unnecessary information collection burden for entities, because farms should be able to tailor their recordkeeping to their specific circumstances while still complying with the requirements of the proposed rule. In addition, as discussed in section IV.E. of this document, the only requirements we are proposing that constitute collections of information are those that are necessary to implement section 419 of the FD&C Act and for the efficient enforcement of the FD&C Act. We propose to require records under this rule only in instances where maintenance of detailed information is needed to keep track of measures directed at minimizing the risk of a known or reasonably foreseeable hazards, where identification of a pattern of problems is important to minimizing the risk of such hazards, or where they are important to facilitate verification and compliance with standards and this cannot be effectively done by means other than a review of records. These instances are discussed in more detail in section IV.E. of this document and throughout section V of this document. In addition, although we recognize their value and encourage their use, we are not proposing to require farms to conduct operational assessments or to develop written food safety plans akin to similar requirements for facilities subject to section 418 of the FD&C Act or our juice HACCP or seafood HACCP regulations. B. Other Provisions of the Federal Food, Drug, and Cosmetic Act FDA's authority for this proposed rule also derives from sections 402(a)(3), 402(a)(4), and 701(a) of the FD&C Act. Section 402(a)(3) of the FD&C Act provides that a food is adulterated if it consists in whole or in part of any filthy, putrid, or decomposed substance, or if it is otherwise unfit for food. Section 402(a)(4) of the FD&C Act provides that a food is adulterated if it has been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health. Under section 701(a) of the FD&C Act, FDA is authorized to issue regulations for the efficient enforcement of the FD&C Act. The proposed rule includes many requirements that are necessary to prevent food from being adulterated (either because it consists in whole or in part of a filthy, putrid, or decomposed substance, because it is otherwise unfit for food, or because it has been held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health). A regulation that requires measures to prevent food from being held under insanitary conditions whereby either of the proscribed results may occur allows for the efficient enforcement of the FD&C Act. See, e.g., regulations to require HACCP systems for fish and fishery products (21 CFR Part 123) and juice (part 120), regulations to require a safe handling statement on cartons of shell eggs that have not been treated to destroy Salmonella organisms and to require refrigeration of shell eggs held for retail distribution (parts 101 and 115), and regulations for the production, storage, and transportation of shell eggs (part 118). C. The Public Health Service Act In addition to the FD&C Act, FDA's legal authority for the proposed rule derives from the PHS Act. Authority under the PHS Act for the proposed regulations is derived from the provisions of sections 311, 361, and 368 (42 U.S.C. 243, 264, and 271) that relate to communicable disease. The PHS Act authorizes the Secretary to make and enforce such regulations as “are necessary to prevent the introduction, transmission, or spread of communicable diseases from foreign countries into the States * * * or from one State * * * into any other State” (section 361(a) of the PHS Act). (See sec. 1, Reorg. Plan No. 3 of 1966 at 42 U.S.C. 202 for transfer of authority from the Surgeon General to the Secretary; see 21 CFR 5.10(a)(4) for delegation from the Secretary to FDA.) The provisions in the proposed rule are necessary to prevent food from being contaminated with human pathogens such as Salmonella, L. monocytogenes, and E. coli O157, and therefore to prevent the introduction, transmission, or spread of communicable disease from foreign countries into the United States, or from one state in the United States to another. As discussed in section II of this document, without appropriate prevention steps, certain practices on farms can lead to the contamination of food with pathogens, increasing the likelihood of foodborne illness. We tentatively conclude that the proposed provisions in this document are necessary to prevent the spread of communicable disease and to prevent food from containing filthy, putrid, or decomposed substances; being otherwise unfit for food, or being prepared, packed, or held under insanitary conditions whereby it may have be [Text truncated at 120,000 characters. The full text is on the page linked above.] --- Source: Frix Law Library, https://www.frixlaw.com/law-library/documents/fr%3A2013-00123. Public record. Not legal advice.