Introduction

The consumption of fresh and minimally processed produce—fruits, vegetables, nuts, and sprouts—has been associated with a series of foodborne illness outbreaks across the United States in recent years. The related symptoms can be severe, even life-threatening.¹ The Food and Drug Administration (FDA) received enhanced authorities to develop and implement food safety regulations from the 2011 FDA Food Safety Modernization Act (FSMA; P.L. 111-353).

Several of the regulations required by FSMA were to be proposed or finalized within one to two years after enactment (by January 2012 or 2013); however, final publication dates for many of these regulations were delayed until 2016 or beyond (see CRS Report R43724, Implementation of the FDA Food Safety Modernization Act (FSMA, P.L. 111-353), by Renée Johnson ). Some rules saw further delays in implementing key provisions after finalization, prompting attention from some Members of Congress.²

The 111^th Congress passed FSMA in response to changes in the global food system and an understanding of foodborne illness and its consequences. Signed into law on January 4, 2011, FSMA amended the Federal Food, Drug, and Cosmetic Act (FFDCA, 21 U.S.C. §§301 et seq.) to expand FDA's authority to establish prevention-focused, scientifically based standards applicable to farms that grow, harvest, pack, or hold fresh produce for human consumption in the United States. In 2015, FDA then published the Standards for Growing, Harvesting, Packing and Holding Produce for Human Consumption (the Produce Safety Rule, or PSR) to implement FSMA produce safety requirements.³ Produce subject to the PSR include but are not limited to various crop categories, such as leafy greens, berries, melons, herbs, tree nuts, legumes, and root vegetables.

This report begins with a brief discussion of the U.S. produce industry. It then discusses key provisions of the PSR, implementation of the rule, and selected issues for Congress.

Foodborne Illness Outbreaks

Although growers and distributors of domestic and foreign produce must comply with various layers of mandatory and voluntary food safety requirements, contaminated produce continues to cause foodborne illness outbreaks. Pathogens—bacteria, viruses, and other biological hazards—are the leading cause of foodborne illnesses. Pathogens may be found in foods of all kinds and often are first acquired at the farm (or harvest) level. Their presence in produce is of particular concern because produce is often consumed without cooking, which is one microbial "kill" step.

The Centers for Disease Control and Prevention (CDC) define a foodborne disease outbreak as occurring when two or more people get the same illness from the same contaminated food or drink.⁴ Based on previous CDC outbreak investigations, microbial hazards associated with produce include pathogenic (disease-causing) strains of Shiga toxin-producing E. coli (STEC), Salmonella, Norovirus or Norwalk-like virus, and Listeria monocytogenes. Other produce-related hazards have involved Cyclospora cayatenensis, Hepatitis A virus, Shigella, and Cryptosporidium. Microbial hazards may be introduced through agricultural and processing water (e.g., agricultural water used in production), soil amendments (such as manure and municipal biosolids), unhygienic practices by workers, unsanitary field and packing facility conditions, and produce transportation and distribution.⁵ In 2015, FDA estimated that the total cost of illnesses linked to all items of produce is approximately $2.5 billion annually.⁶

Since FSMA was enacted in 2011, several high-profile outbreaks have brought attention to effective food safety regulation and enforcement. Many of these outbreaks occurred after the PSR was published in 2015. Table 1 summarizes selected recurring outbreaks of produce, currently subject to the PSR, that involve E. coli, Salmonella spp., Cyclospora cayatenensis, or Listeria monocytogenes, as reported by FDA and CDC from 2011 through 2020.

According to a 2019 study conducted by the U.S. Department of Agriculture's (USDA's) Economic Research Service (ERS), food retailers report that their food safety requirements have evolved as major foodborne illness outbreaks raise awareness of food safety risks. Many produce retailers participating in the study require more stringent food safety audits for produce perceived as high risk, such as lettuce and cantaloupe.⁷ The majority of food retailers also require their suppliers to complete food safety audits for produce not covered by the PSR, such as potatoes. Some retailers further stated they would not buy or have stopped selling produce with a history of foodborne illness outbreaks, such as sprouts.

In response to recent high-profile outbreaks, collaborative efforts between industry groups, foreign governments, and FDA aim to identify and improve production practices most critical for produce safety beyond PSR requirements. For example, the 2020 Leafy Greens STEC Action Plan aims to advance work in three areas: (1) prevention, (2) response, and (3) addressing knowledge gaps.⁸ The Fresh Express Blue-Ribbon Panel on the Prevention of Cyclospora Outbreaks in the Food Supply and the Cyclospora Task Force are two concurrent efforts to identify data gaps and research needs so that improved tools can be developed to detect, prevent, and control Cyclospora contamination of food.⁹

Key Provisions of FDA's Produce Safety Rule

Congress passed FSMA to amend the Federal Food, Drug, and Cosmetic Act (21 U.S.C. §§301 et seq.), which governs foods under FDA's jurisdiction. As required by FSMA, FDA has developed and implemented mandatory food safety and traceability requirements for farmers, packers, and processors of domestically produced and imported products. Selected provisions that broadly address produce are shown in the text box titled "Selected Produce-Related FSMA Provisions," below.

At the farm production level, FSMA principally affects produce growers by directing FDA to establish and enforce produce safety standards (P.L. 111-353, §105, 21 U.S.C. §350h). FDA finalized its produce safety regulation in 2015.¹⁰ FDA's PSR addresses certain routes of potential contamination, including

• water and soil amendments used in production,
• domesticated and wild animal intrusions into production areas,
• worker training and hygiene, and
• equipment and sanitation practices used in production.

Notably, due to limitations of FDA authority, PSR requirements are intended to prevent microbial contamination of fruits and vegetables. The PSR does not include provisions to prevent chemical contamination of these products.

Producer Compliance with FSMA Rules

The PSR covers fruits and vegetables, mushrooms, sprouts, peanuts, tree nuts, and herbs. FDA estimates that the regulation covers as many as 37,000 domestic produce farms and 285 sprout operations.¹¹ FDA further estimates PSR implementation will cost farms an average of approximately $10,500 annually.¹² Foods not covered by regulation include foods that are rarely consumed raw,¹³ foods that go to commercial processing, foods produced for personal consumption, and certain foods identified as low risk. Produce that undergoes certain minimal commercial processing, such as bagged salads and fresh-cut fruits and vegetables, are further covered by FDA's rule on preventive controls affecting food facilities (§103, 21 U.S.C. §350g).

Other FSMA requirements affecting minimally processed produce facilities include records access (§101, 21 U.S.C. §350c), registration of food facilities (§102, 21 U.S.C. §350d), and inspections (§201, 21 U.S.C. §350j). FSMA requirements affecting foreign farms and imported produce include the Foreign Supplier Verification Program (FSVP) (§301, 21 U.S.C. §384a), import certifications (§303, 21 U.S.C. §381(a)), inspections of foreign food facilities (§306, 21 U.S.C. §384c), and accreditation of third-party auditors (§307, 21 U.S.C. §384d). Certain qualified farms and facilities are exempt from regulation depending on business size, among other factors (see "Modified Requirements and Qualified Exemptions").

The compliance dates for FSMA rules are being phased in according to business size (Table 2). Very small farms (those for which the average annual monetary value of produce sold during the previous three-year period is no more than $250,000) generally have more time to comply with rule requirements than larger farms. Farms below the $25,000 sales threshold are exempt from the PSR,¹⁴ and they do not have to implement FSMA standards or maintain paperwork to prove their standing as exempt. In May 2019, water-related compliance dates were extended an additional two years past their original compliance dates (84 Federal Register 9706) due to continued stakeholder feedback questioning the feasibility and cost involved with water testing requirements (see "Agricultural Water"). Farms beneath the $25,000 monetary threshold are exempt from the PSR. These farms do not have to implement FSMA standards or maintain paperwork to prove their standing as exempt (see "Modified Requirements and Qualified Exemptions").

Traceability and Surveillance

In FSMA, Congress also addressed food traceability (§204, 21 U.S.C. §2223) and surveillance (§205, 21 U.S.C. §2224). Traceability refers to the ability to fully trace the movement of food and ingredients through each specific stage of production, processing, and distribution and the ability to identify the origin of food and ingredients when a food or finished product is found to be unsafe. Full traceability often requires extensive recordkeeping, other types of traceback mechanisms, or both. FSMA directed FDA to establish pilot projects to improve its capacity to effectively and rapidly track and trace foods in the event of an outbreak and directed CDC to enhance foodborne illness surveillance systems (§205, 21 U.S.C. §2224). FDA's traceability pilot projects were completed in 2012.¹⁵ In addition to the pilot projects, FSMA directed FDA to designate high-risk foods that require additional recordkeeping to protect public health. Results from the pilot projects and the FSMA recordkeeping requirements were included as components of the FDA proposed traceability rule.

On July 13, 2020, FDA Commissioner Stephen Hahn announced the New Era of Smarter Food Safety Blueprint.¹⁶ The blueprint outlines the approach FDA is to take over the next decade to usher in the New Era of Smarter Food Safety.

The blueprint has four core elements:

• Enhance tech-enabled traceability;
• Develop smarter tools and approaches for prevention and outbreak response;
• Address new business models and retail modernization to reduce contamination of food; and
• Foster the development of stronger food safety cultures.¹⁷

In October 2020, FDA created working groups dedicated to each of the four core elements and has begun identifying short-term goals to be accomplished by 2022.¹⁸ As of February 2021, FDA had not yet finalized the traceability rule.

Produce Safety at FDA Prior to FSMA

Although the PSR is the first federal regulation focusing on microbial food safety at the farm level, it is not the first effort to improve the safety of produce. Produce farms are subject to several layers of federal and state requirements. Commercial buyers (retailers, foodservice firms, and produce processors) also have demanded certain food safety practices from growers for years. Produce growers and grower organizations also are instrumental in raising food safety standards.

Starting in the late 1960s, FDA established current good manufacturing practices (cGMPs) in the Code of Federal Regulations (21 C.F.R. Part 110) to help ensure food manufacturing facilities would implement protocols to prevent food contamination.¹⁹ Farms are exempt from these requirements. Drawing from cGMPs, the 1998 Guide to Minimize Microbial Food Safety Hazards for Fresh Fruit and Vegetables (good agricultural practices, or GAPs) established a collection of nonbinding GAPs that farms should implement to prevent produce contamination.²⁰ Prior to FSMA, state and industry-led produce safety programs were based on these recommendations.

State legislatures set requirements for farms based on GAPs, which often varied widely from state-to-state and commodity-to-commodity. However, USDA's GAP/Good Handling Practices (GHP) program provided a uniform nationally and internationally recognized assessment option for the food industry to ensure produce is grown and handled in a manner that prevents microbial contamination.²¹ Produce farms that choose to participate in the GAP/GHP fee-for-service program pay a third-party GAP/GHP auditor to perform the assessment. Third-party auditors commonly come from organizations such as state departments of agriculture, university extensions, and consulting firms. The GAP/GHP audits have been updated to align with the PSR; however, both FDA and USDA maintain that the audits do not replace regulatory inspections to determine compliance with the rule.

Industry-led food safety practices, in addition to federal standards, drive producers to participate in other voluntary auditing programs,²² the requirements of which often extend beyond regulatory standards and increase market access. These standards commonly exist as public-private partnerships or buyer requirements. For example, the California and Arizona Leafy Greens Marketing Agreements (CA-LGMA and AZ-LGMA,²³ respectively) are collaborative efforts between state authorities and industry leaders who set commodity-specific guidelines to drive food production safety practices. Fresh produce growers and distributors must also meet food production safety standards set by individual customers. These standards include passing multiple audits, establishing microbial sampling protocols, and maintaining various records. As a result, fresh produce growers and distributors may need to comply with multiple layers of food safety requirements (see "FDA-USDA " for additional information on current voluntary programs).

Farms Subject to the Produce Safety Rule

Produce farms must meet several criteria for the operation to be subject to PSR requirements, including the following:²⁴

• Farms must be classified as a primary production or secondary activities farm.
• Farms must perform covered activities on covered produce.
• Farms must meet monetary threshold criteria.
• Produce must not be for personal/on-farm consumption (items used for this purpose are not subject to the PSR).
• Produce must not be intended for commercial processing where produce is cooked or receives processing that reduces microbes "of public health significance."

Key definitions that appear in the PSR are described in the "Selected Definitions from the Produce Safety Rule (PSR)" text box.

The rule does not apply to primary production and secondary activities farms that have an average annual value of produce sold during the previous three-year period of $25,000 or less. Such farms are considered to be exempt.

Produce subject to the PSR include but are not limited to various crop categories, such as leafy greens, berries, melons, herbs, tree nuts, legumes, and root vegetables. Rather than identify a wide variety of produce subject to the PSR, FDA specifically identifies an exhaustive list of rarely consumed raw (RCR) produce that are exempt from the requirements.²⁵ The rule does not apply to

• produce that is not a raw agricultural commodity (RAC);²⁶
• the following RCR produce:²⁷ asparagus; black beans, great Northern beans, kidney beans, lima beans, navy beans, and pinto beans; garden beets (roots and tops) and sugar beets; cashews; sour cherries; chickpeas; cocoa beans; coffee beans; collards; sweet corn; cranberries; dates; dill (seeds and weed); eggplants; figs; ginger; horseradish; hazelnuts; lentils; okra; peanuts; pecans; peppermint; potatoes; pumpkins; winter squash; sweet potatoes; and water chestnuts;
• food grains, including barley, dent- or flint-corn, sorghum, oats, rice, rye, wheat, amaranth, quinoa, buckwheat, and oilseeds (e.g., cotton seed, flax seed, rapeseed, soybean, and sunflower seed); and
• produce that is used for personal or on-farm consumption.

A primary production or secondary activities farm may be classified as a mixed-type facility if the business performs both farming activities and manufacturing activities. For example, a farm that grows and harvests berries destined for wholesale to a grocery distributor may also reserve a portion of those berries to make jam that is to be sold in a farmer's market. Because this is a mixed-type facility, multiple regulations would apply, including the PSR, the Preventive Controls for Human Food (PCHF) rule,²⁸ as well as other federal, state, and local regulations. Table 3 provides a summary of criteria that apply to primary and secondary activities farms. Figure 1 shows FDA's coverage and exemptions flowchart to help farm operators determine if their produce and operations are subject to the PSR.

Modified Requirements and Qualified Exemptions

The PSR provides a qualified exemption and modified requirements for certain farms. To be eligible for a qualified exemption, a farm must meet two requirements.

• 1. The farm must have food sales averaging less than $500,000 per year during the previous three years.
• 2. The farm's sales to qualified end users must exceed sales to all others combined during the previous three years.

A qualified end user is either (1) the consumer of the food or (2) a restaurant or retail food establishment that is located in the same state or the same Indian reservation as the farm or not more than 275 miles away. A farm with a qualified exemption still must meet certain modified requirements, including disclosing the name and the complete business address of the farm where the produce was grown, either on the label of the produce or at the point of purchase. These farms also are required to establish and keep certain documentation.

Withdrawal of a Qualified Exemption

A farm's qualified exemption may be withdrawn if there is an active investigation of an outbreak of foodborne illness that is directly linked to the farm. A farm's qualified exemption may also be withdrawn if FDA determines it is necessary to protect the public health and prevent or mitigate an outbreak based on conduct or conditions associated with the farm. The conduct or conditions in question must be material to the safety of the farm's produce covered by the rule.

Before FDA issues an order to withdraw a qualified exemption, the agency may consider one or more other actions to protect public health, including a warning letter, recall, administrative detention, refusal of food offered for import, seizure, or injunction. FDA also must notify the owner, operator, or agent in charge of the farm, in writing, of the circumstances that may lead FDA to withdraw the exemption, provide an opportunity for response within 15 calendar days of receipt of the notification, and consider actions taken by the farm to address the issues raised by the agency. A withdrawn exemption may be reinstated if (as applicable)

• FDA determines that the outbreak was not directly linked to the farm, and/or
• FDA determines that the problems with conduct or conditions material to the safety of the food produced or harvested at the farm have been adequately resolved and continued withdrawal of the exemption is not necessary to protect public health or prevent or mitigate an outbreak of foodborne illness.

Figure 1. Coverage and Exemptions/Exclusions Flowchart

Source: CRS modified from FDA, Coverage and Exemptions/Exclusions Flowchart, at https://www.fda.gov/media/94332/download.

Agricultural Water

FDA's produce safety regulations require all agricultural water to be safe and of adequate sanitary quality for its intended use.²⁹Agricultural water, in part, includes water used during pre-harvest activities (e.g., irrigating, fertilizing, frost/scorch protection) and post-harvest activities (e.g., washing harvested produce, sanitizing tools and equipment, hand washing).³⁰ Agricultural water can be particularly risky when used during post-harvest activities, such as washing, if water coming into contact with produce is contaminated. Due to the potential for agricultural water to contaminate produce, agricultural water provisions of the PSR focus on water quality and testing. Many of the agricultural water recommendations originally published in the 1998 GAPs guide were made mandatory in the PSR. The PSR expanded on the number of water samples for testing, built upon risk profiles of different water sources, and set a no detectable E. coli standard for post-harvest water uses.

Water quality criteria are based on the presence of generic E. coli. E. coli are mostly harmless bacteria that live in the intestines of people and animals and contribute to intestinal health. However, eating or drinking food or water contaminated with certain types of E. coli can cause mild to severe gastrointestinal illness. Some types of pathogenic (illness-causing) E. coli, such as Shiga toxin-producing E. coli (STEC), can be life-threatening. PSR agricultural water standards aim to prevent contaminated water from contacting covered produce by requiring agricultural water testing to determine water quality.

There are two PSR numerical water quality criteria based on the presence of generic E. coli. The first of the criteria requires no detectable E. coli. when agricultural water is used during activities where the water may come in contact with covered produce or food contact surfaces, such as during harvest or post-harvest activities. This criterion, for example, applies to water used for hand washing, commodity washing, and irrigating sprouts. The PSR's other numerical criteria apply to agricultural water that is directly applied to growing produce (other than sprouts). These criteria establish the maximum amount of E. coli allowed for agricultural water used to grow produce and are based on the average amount of generic E. coli and the variable quantity of E. coli in the waters.³¹ Testing frequency is based on the type of water source. Table 4 provides selected numerical microbial water quality criteria.

FDA received extensive comments to the proposed PSR,³² published in 2013 (78 Federal Register 3504), and the supplemental proposed PSR, published in 2014 (79 Federal Register 58434). Many of the comments expressed concern with financial burdens associated with implementing agricultural water standards, testing methodologies, and use of generic E. coli as an indicator of fecal contamination. According to FDA, after the final PSR was published in 2015, many stakeholders continued to assert during FDA farm visits and at industry gatherings across the country that the agricultural water regulatory scheme was too complex and too burdensome.³³ The agricultural water compliance dates (see Table 2) have been extended while the FDA considers how best to address concerns about the complexity of the agricultural water requirements and the practicality of implementing them across a wide variety of farms, water sources, and uses. The first compliance dates for large farms become effective on January 26, 2022.

Recent outbreaks of foodborne illnesses associated with the consumption of romaine lettuce and other leafy greens have highlighted the need for a viable option for treating agricultural water against foodborne pathogens (see Table 1). In July 2020, a new protocol was established in collaboration with FDA and the U.S. Environmental Protection Agency (EPA) for developing and registering antimicrobial treatments for pre-harvest agricultural water, such as the water used in farm irrigation systems.³⁴ Companies can now use data developed under this protocol to support the EPA's registration of products that can treat agricultural water against foodborne bacteria. The protocol could provide farmers with a tool to help protect the safety of produce intended for consumers, such as romaine lettuce and other leafy greens. Although farmers are not required to treat their agricultural water, these treatments could help farmers keep their produce safe for consumption. Currently, no registered antimicrobial treatment products are authorized for use on agricultural fields or for treatment of irrigation water systems or ponds.

Biological Soil Amendments of Animal Origin and Human Waste

The PSR requires farms to apply and handle Biological Soil Amendments of Animal Origin (BSAAOs) in a manner that does not contaminate produce. For example, human waste is prohibited from use as a soil amendment, except when used in accordance with EPA requirements. General uses and hazards associated with BSAAOs are described in the "BSAAO Microbial Hazards" text box, below.

The PSR does not require microbial testing of any BSAAOs. Instead, it provides the microbial standards to which BSAAO treatment processes must be validated.³⁵ Growers may use any treatment process or processes that have been validated to meet relevant PSR requirements without the need to test the end products.³⁶ Growers may use one of the two methods stated in the PSR, or they may use another validated method.

The proposed BSAAO requirements received vast public input. FDA first proposed to establish 9-month or 45-day application intervals for BSAAOs depending on the treatment level and application method. After receiving public comments, FDA chose to

• remove application intervals for treated and untreated BSAAOs applied in a manner that does not, under any circumstance, contact the edible portion of the crop,³⁷ and
• postpone establishing an application interval for untreated BSAAOs applied in a manner where contact with the edible portion of the crop is unlikely but possible.

The application interval is postponed pending the results of a risk assessment by FDA and USDA. At the time of the final PSR's publication in 2015, FDA and USDA anticipated the risk assessment would be complete within 5 to 10 years.³⁸

Sprouts

Sprouts represent a special food safety concern because the conditions under which they are produced (time, temperature, water activity, pH, and available nutrients) are ideal for the growth of pathogens, if present.³⁹ Between 1996 and July 2016 in the United States, there were approximately 46 reported outbreaks associated with sprouts, accounting for 2,474 illnesses, 187 hospitalizations, and 3 deaths, including 2 documented outbreaks of Listeria monocytogenes.⁴⁰ In these outbreaks, epidemiological investigations often identified seeds used for sprouting as the most likely source of contamination. Poor sanitation and unhygienic practices at sprout operations also can contribute to sprout contamination. The PSR requires farms to implement practices specific to sprout operations.

PSR requirements specific to sprouts include, for example,⁴¹

• Taking measures to (1) prevent the introduction of dangerous microbes into or onto seeds or beans used for sprouting, and (2) treat seeds or beans used for sprouting (or relying on prior treatment by the seed/bean grower, distributor, or supplier with appropriate documentation).
• Testing of spent sprout irrigation water from each production batch of sprouts for certain pathogens. Sprouts cannot enter commerce until pathogen test results are negative.
• Testing the growing, harvesting, packing and holding environment for Listeria species or Listeria monocytogenes.
• Taking corrective actions if spent sprout irrigation water, sprouts, and/or an environmental sample tests positive.⁴²

Domesticated and Wild Animals

Domesticated animals (e.g., pets, livestock) and wild animals are a concern because they may harbor and spread human pathogens or be difficult to control in ways that contribute to contamination risks and can contaminate food or food contact surfaces.⁴³ The PSR requires produce production farms to take the necessary measures to identify and not harvest covered produce that is likely to be contaminated.

The PSR does not require farms to exclude animals from outdoor growing areas, destroy animal habitats, or clear borders around growing or drainage areas. At a minimum, all covered farms must visually examine the growing area for animal contamination and all covered produce to be harvested, regardless of the harvest method used. In addition, under certain circumstances, the rule requires farms to do additional assessments during the growing season and, if significant evidence of potential contamination by animals is found, take measures reasonably necessary to assist later during harvest. Such measures might include, for example, outlining the affected area with flags.

Worker Health, Hygiene, and Training

Humans can carry a wide variety of pathogens (including Hepatitis A virus, Salmonella spp., E. coli O157:H7, and Cyclospora cayatenensis), which can be transferred onto fruits and vegetables and make other people ill if they ingest the contaminated produce. The PSR requires farm employees to practice good health and hygiene while handling food and food contact surfaces.⁴⁴ Personnel must use hygienic practices while handling covered produce and food contact surfaces to protect against such contamination.⁴⁵ This requirement applies both to personnel who handle covered produce and food contact surfaces and to others who work in the operation.

PSR requirements for health and hygiene include the following:

• Taking measures to prevent contamination of produce and food-contact surfaces by ill or infected persons, for example, instructing personnel to notify their supervisors if they may have a health condition that may result in contamination of covered produce or food contact surfaces.
• Using hygienic practices when handling (contacting) covered produce or food-contact surfaces, for example, washing and drying hands thoroughly at certain times such as after using the toilet.
• Taking measures to prevent visitors from contaminating covered produce and/or food-contact surfaces, for example, by making toilet and hand-washing facilities accessible to visitors.⁴⁶

Farm workers who handle covered produce, food-contact surfaces, or both, as well as their supervisors, must be trained on the importance of health and hygiene and on other topics pertaining to their work duties. The PSR marks the first time FDA has required worker and supervisor training in a food regulation. Training may not be substituted with education or experience. At least one supervisor on the farm must successfully complete training on the standardized curriculum as delivered by the Produce or Sprout Safety Alliances or must successfully complete an equivalent course.

Equipment, Tools, Buildings, and Sanitation

The PSR establishes standards related to equipment, tools, and buildings to prevent inadequate sanitation of these sources from contaminating produce.⁴⁷ This section of the rule covers, for example, greenhouses, germination chambers, and other such structures, as well as toilet and hand-washing facilities.

Measures required to prevent equipment, tools, buildings, and sanitation practices from becoming a route of contamination for covered produce and food contact surfaces include

• appropriate storage, maintenance, and cleaning of tools and equipment (including transport vehicles);
• appropriate placement and use of toilet and hand-washing facilities;
• control of pests;
• maintenance of adequate plumbing; and
• proper disposal of sewage and waste.

Federal and State Inspections

Section 105 of FSMA authorizes FDA to coordinate with USDA and state authorities to perform activities to ensure compliance with the PSR. FDA's approach to compliance has centered on developing a strategy for inspections and training (see "Resources Supporting PSR Implementation" for training programs). To this end, FDA determined state regulatory authorities are to conduct most domestic produce farm inspections, and FDA is to conduct inspections in states without inspectional authority as well as on foreign farms. The National Association of State Departments of Agriculture (NASDA) is the main conduit for states to perform inspections. The association also disperses funds to state groups to perform inspections and provides training. Inspections performed by FDA or states are generally scheduled with the farm owner or operator in charge via a phone call. Unannounced inspections are rare but may occur in limited circumstances.⁴⁸

The first major compliance date for large farms subject to the PSR, other than sprout operations (foreign and domestic), arrived on January 26, 2018; however, FDA delayed inspection of large farms until the spring of 2019. This action was intended to allow FDA and its state partners time to provide additional opportunities for education and outreach, such as through the On-Farm Readiness Review (OFRR) program.⁴⁹ FDA also asked states receiving funding to perform inspections as part of the State Produce Implementation Cooperative Agreement Program (State CAP) to begin routine inspections of large produce farms in spring 2019. Produce farm inspections were delayed again in March 2020 after FDA announced it would postpone all inspections due to the Coronavirus Disease 2019 (COVID-19) pandemic.⁵⁰ Inspections resumed in July 2020, and FDA and states continue to prioritize inspections in a manner that assures inspectors' safety. In FY2019 and FY2020, FDA and states conducted almost 1,000 large farm inspections and 1,400 OFRRs.⁵¹

State Produce Implementation Cooperative Agreement Program

FSMA authorizes FDA to undertake examinations, inspections, investigations, and related food safety activities.⁵² FSMA allows FDA to enter into cooperative agreements with states and territories (State CAP). In 2016, FDA awarded cooperative agreement funding to NASDA to implement or enhance state and territory produce safety programs.⁵³ NASDA further awarded funds to individual states based on the number of farms growing covered produce within the jurisdiction.⁵⁴ Some of the awards (referred to as Competition A) are related to state or territorial capacity building (covering state or territorial food safety infrastructure, education, technical assistance, and inventory resources). Pursuant to awards that include a state or territorial inspection, compliance, and enforcement program (referred to as Competition A/B), the state or territory conducts routine inspections (Figure 2). For states and territories not covered by Competition A/B agreements, FDA conducts routine inspections to assess compliance with the PSR.

Figure 2. Competition A Only and Competition A/B Map

Source: FDA, "State Produce Implementation Cooperative Agreement Program (State CAP)," last accessed November 2020, at https://www.fda.gov/federal-state-local-tribal-and-territorial-officials/grants-and-cooperative-agreements/state-produce-implementation-cooperative-agreement-program-cap. Notes: As February 2021, states that appear in white do not participate in the State Produce Implementation Cooperative Agreement Program. FDA conducts routine inspections to assess compliance with the PSR in states and territories that appear in white and green. State authorities conduct routine inspections to assess compliance with the PSR in states that appear in blue.

The approach of FDA and NASDA to produce safety inspections gives autonomy to state and federal regulators to develop inspection priorities and data collection systems. In the states where the state department of agriculture conducts the inspection and the state has adopted (at a minimum) the authority to enforce the PSR requirements, that state will decide what enforcement action to take in the event of a violation. If the state has not adopted authority to enforce the PSR, the state department of agriculture would inform FDA of the violation, and FDA would determine the appropriate enforcement action. As a result, compliance and regulatory action may differ based on whether the state or FDA is the enforcing authority. Systems developed to track and to identify trends in inspection results are disjointed and do not communicate across state and federal lines (see the "Multi-jurisdictional Communications" section). NASDA supports building a central database for all food safety inspection data, which would allow states and FDA to have access to farm histories, evaluate sector-wide trends, and promote consistent enforcement.

The number of awards and final funding levels under the State CAP is contingent upon FDA appropriations and the submission of a sufficient number of meritorious applications. Funding amounts in future years will depend upon annual appropriations and awardee performance. The total funding available for years one through four (FY2017-FY2020) amounted to approximately $112 million.⁵⁵

PSR standards apply equally to domestic and foreign farms. FDA conducts inspections of foreign farms; however, the number of foreign farms that export fresh produce to the United States outpaces the number of in-person farm inspections FDA can feasibly accomplish in a year. Compliance assessments for foreign farms subject to the PSR are covered by the Foreign Supplier Verification Program (FSVP). With respect to the PSR, FSVP requires importers to verify that their foreign suppliers are producing food in a manner that provides the same level of public health protection as the produce safety regulations and to ensure that their suppliers' foods are not adulterated and are not misbranded with respect to allergen labeling.⁵⁶ Importers must establish and follow written procedures to ensure that they import foods only from approved foreign suppliers. Unapproved foreign suppliers can be used when necessary, on a temporary basis, if such suppliers successfully complete verification activities before importing foods. FDA began routine FSVP inspection of importers of produce from large farms in fall 2019.⁵⁷

Enforcement Discretion of Certain Product Safety Rule Provisions

In January 2018, FDA announced it did not intend to enforce certain provisions in four FSMA rules.⁵⁸ The announcement referred to enforcement discretion, which is a temporary policy guidance whereby FDA does not intend to enforce certain provisions of FSMA rules.⁵⁹ Enforcement discretion focuses, in part, on the "farm" definition and on written assurance requirements.

The "Farm" Definition

The farm definition is a fundamental principle that the produce farming industry and regulators use to determine if a farm is subject to PSR requirements. When FDA uses enforcement discretion, the produce farming industry and regulators might not be able to determine which operations that perform farm-related activities are subject to the rule.

An operation must perform one or more specific activities (e.g., growing, harvesting, packing, holding, and limited manufacturing processes) to be considered a primary production farm. Secondary activities farms perform the same activities as primary production farms (except growing) and must be primarily owned by a primary production farm. However, some establishments fall outside of the current farm definition conduct activities that are typically conducted on farms (Table 5). For example, some operations that might otherwise qualify as secondary activities farms do not because they do not meet the ownership requirement. In this situation, they would be regulated under PCHF.

According to FDA, stakeholders have challenged the classification of establishments that both fall outside of the current farm definition and conduct activities that are typically conducted on farms. FDA recognized the "conundrum" created by "regulating identical facilities that pack or handle raw agricultural commodities sometimes under the Produce Safety Rule (PS) and sometimes under the Preventive Controls (PC) Rule" and implemented enforcement discretion while it reevaluates the farm definition.⁶⁰ As of February 2021, FDA has not set a target date for reevaluating the farm definition.

Written Assurance Requirements

FDA's written assurance requirements intend to provide documentation to a manufacturer, processor, importer, or farmer that the food will be processed to control for hazards before the food reaches consumers. The PSR's written assurance provisions specify,⁶¹ in summary, that produce is eligible for an exemption from many of the requirements if it is to receive commercial processing that reduces harmful foodborne pathogens. Certain other conditions also must be met, including requirements for disclosure statements and written assurances similar to what is required by PCHF and FSVP.⁶² Industry feedback has identified that these provisions would cause stress to produce farms and distributors.⁶³ For instance, certain product distribution chains would require many more written assurances and resources to comply than FDA anticipated during the rulemaking process.

Resources Supporting PSR Implementation

FSMA requires FDA to set standards and administer training and education programs for the employees of state, local, territorial, and tribal food safety officials.⁶⁴ To meet these goals, FDA collaborates with domestic and international organizations to increase the reach of PSR implementation assistance. These government, nongovernment, and private industry groups foster critical communication with farms to increase the availability of resources necessary to support education and compliance. FDA's partnerships with organizations, such as USDA's National Institute of Food and Agriculture (NIFA), the Association of Food and Drug Officials (AFDO), and university extension services provide a scaffold to accomplish education and training goals established as part of PSR implementation. Congress has provided more than $300,000,000 in FDA's base appropriation for FSMA-related goals since FY2011 (H.Rept. 115-232).

FDA-USDA Resources Supporting Produce Safety

In FY2019, the Food Safety Outreach Program expanded upon the FY2015 national infrastructure established by NIFA and FDA, known as the National Food Safety Training, Education, Extension, Outreach, and Technical Assistance Competitive Grants Program.⁶⁵ The purpose of the grant program is to train owners and operators of small businesses, including small and medium-sized farms, beginning farmers, socially disadvantaged farmers, small processors, or small fresh fruit and vegetable merchant wholesalers, as well as farms that lack access to food safety training and other educational opportunities.⁶⁶ Grants issued through this program are funding a National Coordination Center (NCC) and four Regional Centers (RCs),⁶⁷ which will be involved in two key components of training—facilitating training delivery and, in certain situations, facilitating curricula development targeted to specific audiences.

Table 6 summarizes key cooperative agreements to help with the implementation of PSR-related education, training, and outreach.

NASDA has played many roles in PSR implementation. In 2014, NASDA began a multiyear cooperative agreement to help implement the PSR.⁶⁸ As a part of the cooperative effort, NASDA established the State CAP (see "State Produce Implementation Cooperative Agreement Program") and developed a proposed NASDA Model Produce Safety Implementation Framework for states to consider as they prepare for PSR implementation.⁶⁹ NASDA has also developed an OFRR process,⁷⁰ in conjunction with the FDA and extension services, to offer a voluntary, nonregulatory opportunity to assess a farm's readiness for FSMA compliance. The majority of NASDA's funding recipients are operating education and outreach programming along with compliance and enforcement.

FDA is continuing cooperative agreements with the National Farmers Union and the University of Arkansas Indigenous Food and Agriculture Initiative (IFAI) to enhance food safety under FSMA.⁷¹ The National Farmers Union plans to conduct targeted outreach, education, and training to local food producers and processors, including beginning and socially disadvantaged farmers, traditional farmers, urban farmers, small farmers and processors, and other supply-chain participants, through the National Farmers Union Food Safety Collaborative Project.⁷² The IFAI plans to conduct outreach, education, and training to Native American tribes.⁷³

FDA, in collaboration with the Agricultural Marketing Service (AMS) of USDA and Cornell University, has established the Produce Safety Alliance (PSA).⁷⁴ FDA also established the Sprouts Safety Alliance (SSA) in collaboration with the Illinois Institute of Technology's Institute for Food Safety and Health (IIT IFSH).⁷⁵ Both PSA and SSA have developed and disseminated science- and risk-based training and education programs. Referred to collectively as "the Alliance courses," they provide produce farms with fundamental, on-farm food safety knowledge and equip them to comply with the PSR. FDA has recognized the PSA and SSA training materials as the standardized curricula that are consistent with the requirements of the PSR. Farms can fulfill the training requirement by either successfully completing the Alliance course appropriate for their farming operation or completing an equivalent course. FDA has published guidance on identifying alternate curricula.

International Programs

The Produce International Partnership for Education and Outreach (PIP) is a joint effort among the University of Maryland Joint Institute for Food Safety and Applied Nutrition (JIFSAN), the PSA based at Cornell University, and multinational industry leaders to provide food safety training to the international community that satisfies the PSR-required training. PIP draws from existing cooperative agreement resources to support international outreach. PIP is responsible for translating the existing PSA curriculum and offering training to international audiences.⁷⁶ Additionally, PIP has an active role in collaborating with international industry associations, universities, government organizations, and others in the development and delivery of training programs that address the local and regional needs of foreign farms in complying with the PSR.

In an effort to enhance food safety across the southern border, FDA and Mexican authorities with regulatory oversight of farms, packinghouses, and food manufacturing facilities created the Food Safety Partnership (FSP). FSP establishes the intent to continue collaborations that strengthen food safety capabilities in each country. Signed in 2020, FSP prioritizes outbreak response, laboratory collaboration, foodborne illness prevention, outreach, and training.

FDA signed a systems recognition agreement in 2016 with the Canadian Food Inspection Agency (CFIA).⁷⁷ FDA's and CFIA's systems recognition involves a bilateral review of each country's domestic food safety regulatory system to determine if it has legal authorities and regulatory tools that together provide public health outcomes comparable to those provided by either FDA or CFIA. This puts both countries in a unique position of mutual reliance to deliver education, training, and outreach to farming communities, as well as to perform regulatory inspections per the PSR.

Although FDA and CFIA have a systems recognition agreement, Canada has taken a tough stance on lettuce imported from the United States. On October 2, 2020, CFIA announced new requirements for romaine imported into Canada from the United States.⁷⁸ Importers must hold a Safe Food for Canadians license and provide a Proof of Origin (state and county) for romaine lettuce and products containing romaine lettuce from outside of the California counties of Santa Cruz, Santa Clara, San Benito, and Monterey. If romaine is sourced from California or Arizona, the importer must source romaine only from those companies certified by the respective LGMAs. Additionally, shipments of romaine sourced from the Salinas growing region (Santa Clara, Santa Cruz, San Benito, and/or Monterey counties) or romaine of unknown or undeclared origin must be accompanied by a certificate of analysis demonstrating that the product does not contain detectable levels of E. coli O157:H7.

Considerations for Congress

As foodborne illness outbreaks continue, some have questioned the effectiveness of FDA's implementation of FSMA. Despite changes enacted as part of FSMA, the U.S. Government Accountability Office has regularly placed federal oversight of U.S. food safety on its biennial High Risk List since 2007,⁷⁹ and it has recommended that the United States take steps to "improve the federal food safety oversight system and address ongoing fragmentation."⁸⁰ In one instance involving the contamination event that led to three outbreaks of E. coli O157:H7 during the fall of 2019, the investigation report linked the outbreak strain to a fecal-soil composite sample collected near an animal production facility.⁸¹ The samples were specifically collected from public land immediately adjacent to the animal facility because federal and state inspectors did not have jurisdiction to collect samples directly from the cattle ranch. Legislation introduced in the 116^th Congress would have authorized FDA to request access to concentrated animal feeding operations during foodborne illness investigations (H.R. 5415, S. 2958).

Several factors might have contributed to FDA's delays in fully implementing key FSMA produce safety standards. FDA's authority to conduct inspections on farms and annual reporting requirements are limited as compared with its authority to carry out these activities in food facilities. FDA also has postponed compliance with certain key PSR requirements and have not fully implemented FSMA's traceability requirements pertaining to high-risk foods in response to continued consideration of industry feedback. Additionally, the lack of coordination of inspectional data between FDA and state and local authorities may lead to inconsistent implementation on rule requirements on farms, as state and local authorities often bear most of the responsibility for inspecting farms and food facilities within their jurisdictions.

Enforcement and Reporting

Operations that handle RACs may be subject to either PSR or PCHF based on factors such as the types of activities performed on RACs and on business ownership (see "Enforcement Discretion of Certain Product Safety Rule Provisions"). FDA's authority to conduct inspections on operations that perform similar activities differs. Farms that produce certain foods identified as high-risk for contamination may not fall within FDA's more stringent requirements for inspection frequency and reporting.

For example, Section 105 of FSMA authorizes FDA to coordinate with USDA and states to perform activities to ensure compliance with the PSR. Section 201 of FSMA requires FDA to identify and prioritize inspections of high-risk food facilities, which does not include farms.⁸² Facilities that handle high-risk foods and may be subject to traceability requirements, including leafy greens, tomatoes, and melons. Since farms subject to the PSR are not defined as facilities, FDA does not have authority to apply critical inspection frequency and annual reporting requirements of FSMA's Section 201 to farms. Congress could revisit FDA's enforcement capabilities on farms and consider whether to strengthen reporting requirements through additional authorizations, appropriations, or oversight.

Traceability of High-Risk Foods

Section 204 of FSMA requires FDA to designate foods for which additional recordkeeping requirements are appropriate and necessary to protect public health.

On September 23, 2020, FDA published the Requirements for Additional Traceability Records for Certain Foods proposed rule (traceability rule).⁸³ The rule proposes to establish additional traceability recordkeeping requirements for persons that manufacture, process, pack, or hold foods the agency has designated for inclusion on the FTL.⁸⁴ The proposed rule would exempt, in part, farms (and the farm activities of farm mixed-type facilities) that are not subject to the PSR because they have less than $25,000 in average annual produce sales. A potential public health concern about this proposed rule is that there are no restrictions for where produce from exempt farms may be sold. For example, if a farm exempt from PSR requirements sells cucumbers to a distributor who comingles produce from several other farms during repacking, the contaminated cucumbers can potentially cross-contaminate other cucumbers from farms that followed PSR requirements. One alternative Congress could consider to prevent potential contamination from comingling would be to require farms to meet two criteria to be exempt from the traceability rule:

• less than $25,000 average annual sales of produce sold during the previous three year period, adjusted for inflation (currently proposed); and
• greater than 50% of annual produce sales to qualified end users as defined in 21 C.F.R. §112.3.⁸⁵

Multi-jurisdictional Communications

Domestic farm inspections are generally conducted by state authorities. Most states have either adapted the requirements of the PSR into their state laws or perform inspections on behalf of FDA. Upon the conclusion of farm inspections, FDA inspectors provide a Produce Farm Observation Form 4056. FDA and NASDA have agreed that states are to have the option to provide Form 4056 or to choose an alternate method to deliver feedback. Because the FDA form is optional for states, there is no central repository to aggregate inspectional findings. Also, farms are not required to register with FDA per the Bioterrorism Act of 2002, as is required of food manufacturing facilities.⁸⁶ FDA and states are generally unable to develop a farm inventory to accurately identify farms; track and identify trends in inspectional results; and provide consistent, region-specific responses to business questions and concerns.⁸⁷ This may result in inconsistent application of rule requirements, potentially hazardous produce from unknown farms entering the food supply, and missed opportunities for program improvement. Congress could consider the costs and potential food safety benefits of authorizing FDA to develop a farm registry and unified inspection database in cooperation with states.