FSMA Proposed Rule for Produce Safety
Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption
Farmer's Toolkit (PDF:281KB)
Docket Folder for the Proposed Rule, includes all references and public submissions
List of Subjects (codified section) of the proposed rule
Fact Sheet (including Summary and Background Information)
Also available in a print-friendly PDF (206KB).
Fact Sheets on subparts of the proposed rule
- Purpose and Need: Why the Produce Safety Rule is Not Limited to Specific Commodities Associated with Past Outbreaks (PDF: 129KB)
- What is Not Covered by the Produce Safety Rule (PDF: 752KB)
- Entities Potentially Affected by the Produce Safety Rule (PDF: 136KB)
Presentation on the Proposed Rules for Produce Safety and Preventive Controls for Human Food (PPT, 2.6MB)
Preliminary Regulatory Impact Analysis
On January 4th, the Produce Safety proposed rule and its accompanying Preliminary Regulatory Impact Analysis (PRIA) statement were posted on the site. An incorrect version of the PRIA statement was posted at that time. On January 16, 2013, a corrected version of the PRIA statement was posted.
Draft Qualitative Assessment of Risk to Public Health From On Farm Contamination of Produce, see FDA-2011-N-0921 reference 2
- FDA seeks comments on specific issues in the proposed rule, see "Section IX. Comments" of the proposed rule
Comment Period closed on November 22, 2013
- Environmental Impact Statement for the Proposed Rule, Standards for Growing, Harvesting, Packing, and Holding of Produce for Human Consumption
April 4, 2014
- Proposed Rules to Establish Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption and for Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food; Portland, OR
March 27-28, 2013
- Proposed Rules to Establish Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption and for Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food; Chicago, IL
March 11-12, 2013
- Proposed Rules to Establish Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption and for Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food; Washington, DC
February 28 - March 1, 2013
Additional Information on the Rulemaking Process:
- The Food Safety Law and the Rulemaking Process: Putting FSMA to Work
- History of the Proposed Produce Safety Rule / Rulemaking Process (PDF: 150KB)
On January 4, 2013, FDA released for public comment its proposed rule to establish science-based standards for growing, harvesting, packing and holding produce on domestic and foreign farms. The proposed rule is one of five proposed rulemakings that would lay the cornerstone of the prevention-based, modern food safety system we need.
Section 105 of the Food Safety Modernization Act (FSMA) directs FDA to set science-based standards for the safe production and harvesting of fruits and vegetables that the Agency determines minimize the risk of serious adverse health consequences or death. FDA proposes to set standards associated with identified routes of microbial contamination of produce, including: (1) agricultural water; (2) biological soil amendments of animal origin (3) health and hygiene (4) animals in the growing area and (5) equipment, tools and buildings. The proposed rule includes additional provisions related to sprouts.
The proposed produce rule covers most fruits and vegetables while they are in their raw or natural (unprocessed) state. It would not apply to raw agricultural commodities that are rarely consumed raw, those produced for personal or on-farm consumption, and (with certain documentation) those destined for commercial processing, such as canning, that will adequately reduce microorganisms of public health concern.
Some farms would not be covered by the rule, or would be eligible for a partial exemption based on factors including the monetary value of their food sales and to whom they sell. The partial exemption would still subject eligible farms to certain modified requirements, and could be withdrawn in certain circumstances.
FDA is proposing that the requirements be effective 60 days after a final rule is published in the Federal Register. Recognizing that small and very small businesses may need more time to comply with the requirements, compliance dates would be phased in based on business size.
In a separate Federal Register notice, FDA will be announcing a series of public meetings to explain the proposal and additional proposed rules and to provide additional opportunity for input.
FSMA was signed into law by President Obama on January 4, 2011 to better protect public health by helping to ensure the safety and security of the food supply. FSMA embraces preventing food safety problems as the foundation of a modern food safety system.
It is widely recognized that produce is an essential component of a healthy diet, and the safe production and harvesting of fruits and vegetables helps consumers to maintain healthy diets. Foodborne illness outbreaks associated with contaminated produce over the last decade have caused a widespread recognition that we need a new, modern food safety system that prevents food safety problems in the first place--not a system that just reacts once they happen. FDA’s analysis of available foodborne illness outbreak data document 131 outbreaks associated with contaminated produce between 1996 and 2010, causing more than 14,000 illnesses and 34 deaths. These foodborne illness outbreaks were caused mainly by biological hazards such as Salmonella, E. coli O157:H7, Shigella, Hepatitis A, and Cyclospora. Therefore, the proposed FDA produce rule focuses on setting enforceable standards that are reasonably necessary to prevent the introduction of known or reasonably foreseeable biological hazards and providing reasonable assurances that produce is not adulterated on account of these hazards.
The proposed rule builds on the more than 10 years of produce safety activities by the FDA, as well as the produce industry and other stakeholders, to put in place science-based best practices and standards for the growing, harvesting, packing and holding of fruits and vegetables. For instance, the FDA has issued guidance to the industry on Good Agricultural Practices (GAPs) and commodity-specific guidance on sprouts, and has also developed draft commodity-specific guidance that addresses food safety considerations for tomatoes, melons and leafy greens. Industry efforts have included development of numerous commodity-specific guidance documents that address on-farm food safety practices. Additionally, the industry, in collaboration with the U.S. Department of Agriculture and State departments of agriculture, has developed Leafy Greens Marketing Agreements in California and Arizona. In 2009, the Association of Food and Drug Officials published a Model Code for Produce Safety that was developed with input from industry, consumer groups, researchers, and state and local public health officials. Florida also passed state regulations for the safe production and handling of fresh market tomatoes. We also considered relevant international guidelines related to the safety of fruits and vegetables in developing this proposed rule.
Who is Covered by the Rule?
The proposed rule would establish science-based minimum standards for the safe growing, harvesting, packing, and holding of produce in its raw or natural (unprocessed) state on farms. For the purposes of this proposed rule, produce means fruits and vegetables grown for human consumption. This would include, for example, lettuce, spinach, cantaloupe, tomatoes, sprouts, mushrooms, onions, peppers, cabbage, citrus, strawberries, and walnuts. The FDA proposed produce safety rule considers both the commodity and the practices associated with growing, harvesting, packing and holding produce as well as how produce will be used and consumed after it leaves the farm. The proposed produce rule provides growers flexibility in their approach to on-farm food safety, so that food safety practices being taken by farmers can be appropriate for the scale of production and type of agricultural practices being used.
Farm mixed-type facilities (farms that are also engaged in activities outside the definition of “farm” that require food facility registration), may be subject to both the proposed produce safety rule and the forthcoming preventive controls proposed rule, depending on whether any exemptions apply. An example is an establishment that grows and harvests produce but also conducts activities such as processing fresh-cut produce that requires the establishment to be registered. In such cases, only the establishment’s “farm” activities would be subject to the proposed produce safety rule.
Limitations on Coverage of the Proposed Rules
As required by Congress, farms would be partially exempt from the proposed rule if they meet two requirements. First, they must have food sales averaging less than $500,000 per year during the last three years (adjusted for inflation). Second, their sales to qualified end-users must exceed their sales to others during the same period. A qualified end-user is either a consumer (in any location) or a restaurant or retail food establishment located in the same State as the farm or not more than 275 miles away from the farm. However, FDA may withdraw this partial exemption if the farm is directly linked to an outbreak, or if FDA determines it is necessary to protect the public health and prevent or mitigate an outbreak based on conditions or conduct that create the potential for the farm’s produce to cause an outbreak.
If a farm qualifies for this partial exemption, certain labeling requirements would apply. That is, if a label is otherwise required on the produce that would otherwise be covered (tomatoes packaged in a clam shell are an example) then the label must include the name and business address of the farm where the produce was grown. If a label is not required then the name and business address of the farm where the produce was grown must be displayed at the point of purchase (such as on a poster, for example).
In addition, the proposed rule excludes certain produce that constitute the lowest risk with respect to biological hazards. Examples include produce that is rarely consumed raw, such as potatoes, or that is destined for further processing that includes a kill step (with certain documentation), such as green beans destined for a canning operation.
The proposed rule also would not apply to produce for personal or on-farm consumption.
FDA also is proposing that the smallest farms—those with an average annual value of food sold during the previous three-year period of $25,000 or less—would not be covered.
Highlights of the Proposed Rule
FDA is proposing to establish science-based minimum standards for the safe growing, harvesting, packing, and holding of produce on farms. The proposed rule focuses on identified routes of microbial contamination of produce, including:
- Agricultural Water. Water used for produce production presents different microbial quality demands depending on its use. Water can be a carrier of many different microorganisms of public health concern. The proposed rule would require that all agricultural water be safe and of adequate sanitary quality for its intended use. “Agricultural water” would be defined in part as water that is intended to, or likely to, contact covered produce or food-contact surfaces. The proposed rule would require that, at the beginning of the growing season, the agricultural water system components under a farm’s control be inspected to identify conditions that are reasonably likely to introduce pathogens to produce or food-contact surfaces. FDA is proposing that specific criteria for the quality of agricultural water be established for water that is used for certain purposes, with proposed requirements for periodic analytical testing.
- Biological Soil Amendments of Animal Origin. Biological soil amendments of animal origin, such as composted manure, may contain pathogens of public health concern. To address this, the rule proposes three types of measures to reduce the risk: types of treatment, methods of application, and time intervals between the application of a biological soil amendment of animal original and crop harvest. The proposed rule also has provisions pertaining to the handling and storage of biological soil amendments of animal origin.
- Health and Hygiene. Bacteria, viruses, and parasites are frequently transmitted from person to person and from person to food, particularly through the fecal-oral route. The proposed rule would require that farm personnel use hygienic practices, including hand washing and maintaining adequate personal cleanliness.
- Domesticated and Wild Animals. Pathogens can be introduced into fruit and vegetable production systems via animal feces. Where there is a reasonable probability that animals will contaminate produce, the rule proposes certain requirements, such as an adequate waiting period between grazing of domesticated animals and harvesting produce from that growing area. Similarly, for working animals used where a produce crop has been planted, farms would be required to take measures to prevent pathogens from being introduced onto the produce. In addition, farms would be required to monitor for significant wild animal intrusion events both immediately before harvest, and, as needed during the growing season, and not harvest produce that is visibly contaminated with animal excreta.
- Equipment, tools and buildings. Among other things, the proposed rule also would set standards for certain equipment and tools, buildings, and sanitation used for produce operations on farms.
Other areas addressed in the standards include:
- Sprouts. Sprouts present a unique risk because the warm, moist, and nutrient-rich conditions required to produce sprouts are the same conditions that are also ideal for the growth of pathogens. The proposed rule would require treating seed before sprouting, testing spent sprout irrigation water (or sprouts, in some cases) for pathogens and monitoring the growing environment for Listeria species or Listeria monocytogenes.
- Training. The proposed rule would require training for farm personnel who handle the produce or food-contact surfaces, and for supervisors.
Alternatives and Variances
The proposed rule would provide that farms may establish alternatives to certain requirements related to water and biological soil amendments of animal origin if the alternative is scientifically established to provide the same amount of protection as the requirement in the proposed rule without increasing the risk of adulteration.
The proposed rule also would allow a state or foreign country to request a variance from some or all provisions of the proposed rule, if the state or country determines that it is necessary in light of local growing conditions, and practices under the proposed variance provide the same level of public health protection as the requirements of the proposed rule without increasing the risk of adulteration. The proposed rule provides a process by which FDA would consider such requests and approve or deny them, and also provides that FDA may specify that an approved variance applies to other farms (for example, those with similar agricultural conditions).
The proposed rule would require certain records, for example, to document that certain of the standards are being met. However, it would not require duplication of records already kept for other purposes.
Effective and Compliance Dates and Definitions for Small and Very Small Businesses
- Effective Date: 60 days after a final rule is published.
- Compliance Dates: For farms that would be covered by the proposed rule, the following definitions and compliance dates would apply:
- Very Small Businesses—a very small business is defined as having, on a rolling basis, an average annual monetary value of food sold during the previous three years of no more than $250,000. These farms would have four years after the effective date to comply; for some of the water requirements, they would have six years.
- Small Businesses—a small business is defined as having, on a rolling basis, an average annual monetary value of food sold during the previous three years of no more than $500,000. These farms would have three years after the effective date to comply; for some of the water requirements, they would have five years.
- Other Businesses—other businesses would have to comply two years after the effective date. For some of the water requirements, they would have four years to comply.
In a separate document cited as a reference to the proposed rule, FDA is issuing a draft qualitative assessment of risk that provides a scientific evaluation of potential adverse health effects resulting from human exposure to hazards in produce, with a focus on the public health risk associated with on-farm microbial contamination of produce. This document helps to inform the proposed produce rule.
Economic Impact of the Proposed Rule
The proposed rule on produce safety is aimed at reducing the public health burden of foodborne illness associated with contaminated produce. We estimate the number of foodborne illnesses that would be prevented by this proposed rule to be 1.75 million, with an associated benefit of $1.04 billion, annually. We estimate the annualized costs of the proposed rule to be $459.56 million annually for domestic farms, and $170.62 million annually for foreign farms covered by the rule (for a grand total of $630.18 million annually). The proposed rule would cover an estimated 40,496 domestic farms and 14,927 foreign farms.
An estimated 75,716 domestic farms that engage in direct farm marketing to qualified end-users would be partially exempted from this proposed rule but will be subject to a labeling requirement. It is estimated that the annual total cost of the labeling requirement will be $3.82 million.
Additionally, an estimated 34,433 farms that grow, harvest, pack or hold produce that have an average annual monetary value of food sold during the previous three-year period of $25,000 or less will not be covered by this proposed rule.
However, the vast majority (approximately 90%) of covered produce acreage grown and consumed by Americans would either be covered by this proposed regulation, consumed cooked, or sent to food processing plants that have processes designed to address biological hazards associated with produce.
Rulemaking Process and Submitting Comments
FDA issues proposed rules in the Federal Register so that the public can review them and submit comments. The official title of the proposed rule is “Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption.”
FDA will consider comments received during the comment period on the proposed rule and then consider revising the rule based on its review of the comments before issuing a final rule. The proposed rule and supporting documents are filed in FDA’s official docket on http://www.regulations.gov and also can be accessed on the FSMA website. When a final rule is available, the rule and its supporting documents will be available in the same place.
FDA has conducted extensive outreach to the produce industry, the consumer community, other government agencies and the international community to gain input and perspective on this and other proposed rules required by FSMA. That input and perspective helped shape the proposed regulations in a way that will help to ensure the proposed rules are practical and flexible, as well as effective. FDA will be holding several additional meetings, including regional public meetings, during the comment period for these rules.
Assistance to Industry
Assistance to Industry
FDA intends to publish guidance documents, including guidance that explains the requirements of the rule in plain language to help businesses, particularly small and very small businesses, comply with the produce safety requirements. In addition, FDA is working with its partners through the Produce Safety Alliance and the Sprouts Safety Alliance to develop training materials and to disseminate information on produce safety to help industry, particularly small and very small businesses, comply with the a final rule.
The following is Section IX of the proposed produce rule. Please visit, Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption Proposed Rule to view the entire contents of the proposed rule.
Interested persons may submit to the Division of Dockets Management (see ADDRESSES) either electronic or written comments regarding this document. It is only necessary to send one set of comments. It is no longer necessary to send two copies of mailed comments. Identify comments with the docket number found in brackets in the heading of this document. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.
Comments on proposed provisions and related issues—We seek comment on the need for, and appropriateness of, the various provisions proposed in this rule and our accompanying rationale. Specifically, we seek comment on the following issues:
- Proposed provisions in subpart A, including:
â—‹ proposed §§ 112.1 and 112.2, including the produce that would be covered or not covered by the rule; the list of produce that would not be covered by the rule because it is rarely consumed raw (including asparagus, bok choy, and cranberries); and the proposed exemption for produce that receives commercial processing, including the types of processing that should qualify for this exemption;
â—‹ proposed definitions in § 112.3(c), including those of agricultural water, hazard, reasonably foreseeable hazard, produce, humus, production batch of sprouts, and yard trimmings;
â—‹ proposed definitions of small and very small businesses in § 112.3(b); as well as the proposed exclusion of certain farms from the scope of this rule based sales in § 112.4(a);
â—‹ whether and how we should require farms that meet the criteria for the qualified exemption to establish and maintain documentation of the basis for their exemption;
â—‹ the feasibility of the labeling provisions in proposed 112.6(b), particularly in the case of consolidating produce from several farm locations.
- Proposed general requirements in § 112.11, including on whether we should establish specific standards for any types of hazards that would be covered in proposed § 112.11 but for which we have not proposed specific standards in proposed subparts C through O; and the proposed allowance in § 112.12 for alternatives to certain specified requirements, including appropriateness of the list of permitted alternatives. Are there other proposed provisions for which we should permit alternatives and, if so, under what, if any, additional or different criteria than those proposed in § 112.12(b) and (c)?
- Proposed provisions in subparts C and D directed to personnel training, and health and hygiene, including the proposed requirements for training on principles of food hygiene and food safety, and for the maintenance of adequate personal cleanliness and hygienic practices when handling covered produce or food-contact surfaces during covered activities, including the provisions relevant to use of gloves and hand sanitizers;
- Proposed provisions directed to water, including those related to water quality, microbial indicators, and testing in §§ 112.41, 112.44, and 112.45; provision related to water sourced from public water systems in § 112.45(a); and recordkeeping in § 112.50; specifically:
â—‹ Are the provisions in §§ 112.44-112.46 appropriately tailored to the risk posed by the manner in which the water is used?
â—‹ Are the microbial standards specified in these provisions appropriate for the specified intended uses? For example, are the microbial standards appropriately tailored to uses such as direct application of irrigation water?
â—‹ Are the provisions related to treatment of water sufficiently flexible to permit alternative safe uses of water that does not meet the specified microbial standard for its intended use?
â—‹ Is there a need for a provision specifically related to disinfection treatment of re-circulated or single pass water used during and after harvest?
â—‹ Are there any alternative options not considered in the proposed rule?
- Proposed provisions in subpart F directed to soil amendments, including those related to status, treatment, application restrictions, minimum application intervals, and recordkeeping (including the requirement related to documentation such as Certificates of Conformance); our focus on biological soil amendments of animal origin; any alternative options that we have not considered in this proposed rule; and the risk presented by the use of biological soil amendments in sprouting and whether that practice should be prohibited;
- Proposed provisions in subparts I, K, and L, including proposed § 112.81 related to the scope of applicability of subpart I, proposed § 112.114 related to dropped produce, and proposed § 112.115 related to measures to prevent formation of botulinum toxin; specifically:
â—‹ Do you agree with our proposal to apply the proposed provisions in subpart I when covered activities take place in an outdoor area or a partially-enclosed building where there is a reasonable probability of contamination of covered produce, and our tentative conclusion that, accordingly, crops that grow completely underground would not be subject to the proposed provisions of subpart I?
â—‹ With respect to dropped produce, should proposed § 112.114 apply to all commodities or should we provide for certain exceptions (and, if so, under what criteria)? Does proposed § 112.114 appropriately address produce (such as almonds) that is intentionally dropped to the ground during harvesting and where such harvesting does not cause bruising or damage to the produce? Should produce with peelable skin be excluded?
â—‹ Is proposed § 112.115 a reasonably necessary measure to ensure the safety of packaged covered produce? Are there specific types or conditions of modified or reduced oxygen packaging methods that may or may not increase the risk of formation of botulinum toxin?
- Proposed provisions specific to sprouts in subpart M, including treatment of seeds and beans; microbial indicators and frequency of environmental monitoring; and requirement to establish and implement a written environmental monitoring plan (§ 112.144(a)) and sampling plan for each production batch of sprouts (§ 112.146(a)); as well as whether soil-grown sprouts should be subject to the proposed requirements, and whether and how to establish a supplier approval and verification program for seeds and beans used for sprouting;
- Proposed provisions in subpart N, including methods and allowance for alternative methods to be used provided they are at least equivalent to the proposed method in accuracy, precision, and sensitivity;
- Proposed requirements related to documentation and records in subpart O, including the requirement for a supervisor or responsible party to review certain records, and whether there are any circumstances that would warrant not applying part 11 to records that would be required to be kept under part 112;
- Proposed provisions in subpart P for variances, including related process and scientific data and information to support a request for variance, and circumstances for approval or denial of a request for variance and for modification or revocation of an approved variance; Are there any specific concerns that we should consider in finalizing the procedures and processes for requests for variances, as applicable to foreign governments?
- Overall implementation and compliance strategy and proposed provisions in subpart Q, including specific strategies we should employ in order to best prioritize our implementation of the rule, and coordination of education and enforcement activities by relevant State, Territorial, tribal, and local authorities; and
- Proposed provisions in subpart R for withdrawal of a qualified exemption, including related process and timeframes for actions to be taken by FDA or farms.
- Regarding the scope of the recordkeeping requirements, are there alternative options that should be considered?
- Regarding the handwashing and toilet facility requirements, are our proposals reasonably consistent with current model practices or are there alternatives not considered in the proposed rule?
Regulatory approach—As discussed in section IV of this document, we have tentatively concluded that we should use a regulatory framework based on practices, procedures, and processes associated with growing, harvesting, packing, and holding of all covered produce. We considered and rejected the option to develop a framework that (based solely on a history of outbreaks or illnesses associated with the commodity) would be applicable to individual commodities or classes of commodities. Relevant references on the subject of produce safety, as well as the QAR, identify common on-farm routes of contamination, such as personnel training, health, and hygiene; domestic and wild animals; biological soil amendments of animal origin; agricultural water; and equipment and buildings. Procedures, processes and practices in each of these on-farm routes of contamination have the potential to introduce biological hazards into or onto any covered produce. Therefore, we are proposing an integrated approach to prescribe standards for each of these on-farm routes of contamination that we have tentatively determined are reasonably necessary to prevent the introduction of known or reasonably foreseeable biological hazards and to provide reasonable assurances that produce is not adulterated under section 402 of the FD&C Act. We also recognize the need for additional standards specifically tailored to the growing, harvesting, packing and holding of sprouts, and have proposed minimum necessary standards for sprouts. We seek comment on our tentative conclusions related to this issue and the proposed regulatory approach described in section IV of the document. In addition, we seek comment on the following:
- Are there any alternative approaches that we should consider in establishing science-based minimum standards for the safe production and harvesting of produce and to minimize the risk of serious adverse health consequences or death?
- Are there specific commodities or categories of commodities that should be excluded from the scope of the rule, based on data related to their relative risk considerations? (Note that under our proposed integrated approach, we propose to exempt certain commodities, including a specified list of produce that is rarely consumed raw, and produce that receives commercial processing that adequately reduces the presence of microorganisms of public health significance; see section V.A.2.a. of this rule.)
- For example, the QAR ranked certain produce commodities, such as bananas and coconuts, as lower risk for illness, in part because such commodities are peeled or shelled before consumption in a manner that can be expected not to transfer contamination onto the interior, edible portion of the commodity. Should such commodities be covered by the rule? Is coverage of these commodities unnecessary? Should they be covered but subject to a less stringent set of requirements?
- Certain commodities are ranked in the QAR as presenting a relatively lower likelihood of exposure, in part because such commodities have fewer potential routes of contamination and/or lower potential for contamination. In addition, some commodities are not known to have been associated with outbreaks. Some commodities (for example, pears, grapefruit, oranges, and lemons) meet both of these criteria, considering the rankings and outbreak data used in the QAR. Should commodities that meet both of these criteria be covered by the rule? Is coverage of these commodities unnecessary? Should they be covered but subject to a less stringent set of requirements? How should the rule address the changing nature of outbreak data over time?
- How should we account for uncovered commodities in considering a commodity-specific approach that relies on outbreak data?
- Are there pathogen surveillance data from sampling programs focusing on produce commodities that have no history of known outbreaks that would be useful in considering a commodity-specific approach?
- Can commodity characteristics be used as a basis to consider a commodity-specific approach? While the outbreak data show no consistent pattern that can be matched to commodity characteristics such as growth habit, our QAR shows that produce commodities that are ranked as higher risk of illness and those ranked as lower risk of illness do share some of the same characteristics. A further refinement of our assessment might be helpful in developing a commodity-specific approach based on commodity characteristics. Considering the qualitative nature of our assessment, are there quantitative data sets available that would enable a further refinement of our assessment?
- We seek comment on our tentative conclusion that produce in both direct market channels and other commercial channels are subject to the same routes of contamination, although the number of opportunities for contamination during packing and holding may be greater for produce in other commercial channels as compared to produce in direct market channels if there are greater numbers of touch points and handlers in these channels than there are in direct market channels.
- We seek comment on our tentative conclusion that because the statutory qualified exemption addresses market channels as a possible risk factor, and because we identified no data that would allow us to otherwise use market channels as a factor in covering and regulating produce under this proposed rule, we should not otherwise use market channels as a basis of risk categorization in this proposed rule.
- Are other data or information available that would be otherwise useful in considering a commodity-specific approach?
- We seek comment on the proposed effective and compliance dates.
- We seek comment on the appropriateness of the proposed exemptions and partial exemptions. Are there additional exemptions and relevant data to support such exemptions that we should consider?
Qualitative assessment of risk—We seek comment on the QAR, conclusions drawn from that assessment, and our consideration of those conclusions in developing the proposed requirements described in this rule. We also request you to submit any data or factual information that may help the agency to conduct, as warranted, a thorough and robust quantitative assessment of risk associated with produce production and harvesting practices.
Chemical, physical or radiological hazards—We seek comment on our tentative conclusion that procedures, practices, and processes, which are proposed in this rule, are reasonably necessary to prevent the introduction of biological hazards only, and on whether, and to what extent, chemical, physical or radiological hazards should be covered within the scope of a final rule. Are there procedures, practices, or processes that minimize the risk of serious adverse health consequences or death and that are reasonably necessary to prevent the introduction of known or reasonably foreseeable chemical, physical or radiological hazards into produce or to provide reasonable assurances that produce is not adulterated under section 402 of the FD&C Act?
Environmental testing for L. monocytogenes or Listeria spp for covered produce other than sprouts—Proposed § 112.143(a) would require testing the growing, harvesting, packing, and holding environment for sprouts for Listeria species or L. monocytogenes; however, we have not proposed to require environmental testing for other covered produce. A recent outbreak of listeriosis from cantaloupes attributed to insanitary conditions at a facility that washed, packed, cooled and held intact cantaloupes (Ref. 267) raises the question as to whether specific measures are necessary to minimize the risk posed by L. monocytogenes as an environmental pathogen. As discussed in section V.A. of this document, this proposed rule would not apply to off-farm facilities such as the facility associated with this cantaloupe outbreak— such facilities would instead be subject to part 110 and may be subject to section 418 of the FD&C Act. However, the same risk factors and potential measures for minimizing risk are relevant to both on-farm and off-farm produce washing, packing, cooling, and holding practices. Such measures could include environmental testing for L. monocytogenes or Listeria spp. to verify the adequacy of a covered farm's sanitation measures. Because L. monocytogenes is a ubiquitous microorganism, an intact fruit or vegetable could reasonably be expected to occasionally be positive for L. monocytogenes. Many studies have shown the presence of L. monocytogenes on fresh, intact produce, but there is limited epidemiological evidence associating listeriosis with produce, especially with intact fruits and vegetables (Ref. 268. Ref. 269. Ref. 270. Ref. 271. Ref. 272. Ref. 267). However, this recent outbreak indicates that intact produce can be a vehicle for listeriosis. What is not known is the extent to which, and under what circumstances, whole produce contaminated with L. monocytogenes presents a risk to consumers. The outbreak of listeriosis due to contamination of intact cantaloupes appears to have occurred due to a combination of factors, including pooled water on the floor of the facility, which was also difficult to clean, poorly designed equipment that was previously used for other commodities, no pre-cool step, a truck parked near the packing area that had visited a cattle operation, and possible low level contamination from the growing/harvesting operation (Ref. 273). The contribution of internalization of the organism and growth within the fruit is not known. Moreover, it is not known whether all of these circumstances are needed for L. monocytogenes to present a risk on produce or whether any one or more would have been sufficient. We also do not know the prevalence of L. monocytogenes environmental contamination of fruit and vegetable packing facilities (both on- and off-farm), nor do we know the prevalence of L. monocytogenes on produce washed, packed, cooled and stored in such facilities. We encourage research to answer these questions. We request comment on whether we should require, in a final rule, any or all covered farms that wash and pack produce, or that only pack produce, to perform environmental testing for L. monocytogenes or Listeria spp., and any criteria that should be employed to determine which farms should be subjected to such a requirement.
Operational assessment, food safety plans—As discussed in section IV of this document, while we recommend that farms conduct an operational assessment and develop a food safety plan, at this time, we are not proposing to require them to do so. We request comment on whether we should require, in a final rule, some or all covered farms to perform operational assessments and/or develop a food safety plan, and any criteria that should be employed to determine which farms should be subjected to such a requirement.
Registration—We are also requesting comment about whether we should require, in a final rule, that covered farms, as described in proposed § 112.4(a), register with FDA. We are not aware of a nationwide database of farms, nor an accumulation of statewide databases, that would enable us to identify the names and locations of all entities subject to this proposed regulation. This would enable us to better provide outreach and technical assistance to covered entities. In addition, while inspection is intended to be only a relatively minor part of our overall compliance effort (see section V.Q. of the document for more information on our overall strategy), we anticipate performing inspections for enforcement purposes. We would use the covered farm registration information to create a database that we would use to allocate inspection resources. We are also interested in the existence of databases that could help us identify covered farms in the absence of a registration system, and in the appropriate data elements that should be collected in a registration system, should we decide to set up such a system.
Environmental issues—Consistent with § 25.50, FDA is involving the public in implementing its NEPA procedures applicable to this proposed rule. The agency will evaluate the information and input received in response to this proposed rule, including the specific questions below, to determine further actions, as appropriate.
Proposed subpart E would establish standards for an indicator organism in agricultural water applied to covered produce, and establish requirements for waters that do not meet those standards. We are soliciting comments on potential means or mechanisms for meeting the proposed standards. In your responses, please distinguish, to the extent appropriate, between sprouts and other covered produce.
1. Do farms that would be covered by the proposed rule, if finalized, currently treat water used for irrigation directly applied to covered produce other than sprouts, or water used to irrigate sprouts (whether or not it is directly applied)? We are seeking comments on pesticides used to reduce concentration of organisms of concern in water used for such irrigation and not pesticides used to prevent biofouling (chemigation).
2. What actions are currently being taken by farmers, either on their own or at the request of produce handlers or sellers to control the bacterial loads in water? Please provide data to support the information provided.
3. What water treatment methods do farmers use to clean their irrigation systems, how broadly are they used, and what are the effects on the environment? In what amounts or frequency are each of these methods applied? Please provide data to support the information provided.
4. Do farms currently use municipal water sources to irrigate produce that would be covered by this proposed rule, if finalized? If so, please provide data on the use rate and prevalence of this practice, as well as data regarding effects on crop productivity of disinfection byproducts in municipal water used to irrigate produce that would be covered by the rule.
5. What sources of irrigation water (for example, municipal water, surface water and groundwater) are most frequently used? If more than one source is available, is there a preference for using one source over another? Please explain why.
In addition, we seek comment on potential effects of actions taken as a result of this rule on water rights/Tribal rights. Are water rights or Tribal rights likely to be affected by actions taken as a result of this rule? If so, how and to what extent?
Proposed subpart F would require the use of application method restrictions, application intervals, and/or treatment of biological soil amendments of animal origin to reduce exposure of covered produce to organisms of public health concern. We recognize that the requirements in this section may represent a departure from current practices.
1. How do farms that would be covered by the proposed rule, if finalized, currently manage solid animal waste? Manage liquid animal waste?
2. What is the prevalence of composting on farms using methods described in proposed subpart F? Please provide data or other available information on the frequency of such composting.
3. Are composting methods other than those described in proposed subpart F currently utilized on farms? To what extent? Please provide data or other available information on the frequency of such composting.
4. Are currently utilized methods of composting governed by state, county or local laws, ordinances or regulations? Please identify in your comments any relevant laws, ordinances, or regulations, and include copies if reasonably feasible.
5. What are the current laws, ordinances, or regulations in produce growing areas that govern manure handling and storage? How if at all do such laws, ordinances, or regulations address potential environmental effects from methane associated with manure? Ammonia? Nitrogen? Phosphorus?
Under proposed subpart F, manure may be chemically treated as an alternative to composting that would not require use of an application interval. We are also soliciting comments on available chemical treatment methods.
1. Do farms that would be covered by the proposed rule, if finalized, currently utilize chemical treatments to prevent or minimize pathogens in manure?
2. What types and quantities of chemicals are used for chemical treatment of manure? Please describe the treatment protocols, including application time, containment methods, and temperature requirements.
3. Please provide any data or other information relating to the effectiveness, and the relative effectiveness, of these chemical manure treatments, as well as any environmental effects of their use.
Proposed subpart I would apply when under the circumstances there is a reasonable probability that animal intrusion will contaminate covered produce. In such circumstances, proposed subpart I would require monitoring of those areas that are used for a covered activity for evidence of animal intrusion immediately prior to harvest and as needed during the growing season. If significant evidence of animal intrusion is found, these provisions would require farms to evaluate whether the covered produce can be harvested in accordance with proposed subpart K. Proposed subpart K would require taking reasonable measures to identify, and not harvest, covered produce that is reasonably likely to be contaminated, including steps to identify and not harvest covered produce that is visibly contaminated with animal excreta. We are soliciting comments on current practices relevant to these provisions.
1. What measures, if any, are currently being implemented to prevent harvest of produce contaminated by excreta deposited by wild animals? If there are preferred measures, please explain the rationale for such preference. Please provide data to support the information provided.
2. Are farms removing vegetation bordering outdoor produce growing areas or drainages in an effort to deter wildlife from entering growing areas? If so, what is the current rate at which vegetation bordering outdoor produce growing areas or drainages is currently being removed? Are sediment basins or other conservation practices currently being removed and at what rate? Please provide data or other information to support the information provided.
3. To what extent have farmers taken action to exclude wildlife from outdoor produce growing areas? What measures are being used for these purposes, e.g. construction of fences or other physical barriers, chemical deterrents, or other mechanisms around growing areas to exclude wildlife? Please provide data or other information to support the information provided.
4. Has the implementation of measures to prevent animal intrusion negatively impacted habitat for rare or declining aquatic or terrestrial wildlife species or migratory birds? Please provide examples.