Produce Safety: Requirements, Implementation, and Issues for Congress

March 9, 2021 R46706

Produce Safety: Requirements,
March 9, 2021
Implementation, and Issues for Congress
Amber D. Nair
In the United States, fruits, vegetables, nuts, and sprouts continue to be associated with a series of
Analyst in Agricultural
foodborne illness outbreaks across the country, resulting in hundreds of illnesses and
Policy
hospitalizations, as well as kidney failure and death. Many in Congress have expressed concern

that foodborne illness outbreaks are occurring despite enhanced authorities and resources
provided to the Food and Drug Administration (FDA) and state public health authorities

following the 2010 enactment of comprehensive food safety legislation as part of the FDA Food
Safety Modernization Act (FSMA; P.L. 111-353). FSMA amends the Federal Food, Drug, and Cosmetic Act (FFDCA, 21
U.S.C. §§301 et seq.), which required FDA to develop produce safety standards for certain fruits, vegetables, nuts, and
sprouts, as well as other rules to enhance food safety. To provide FDA with the means to implement FSMA, Congress has
provided more than $300,000,000 in FDA’s base appropriation for FSMA since FY2011 (H.Rept. 115-232).
FDA published the Final Produce Safety Rule (PSR) in November 2015 to fulfill FSMA produce safe ty requirements. The
PSR establishes science-based minimum standards to prevent microbial contamination of produce (fruits, vegetables, nuts,
and sprouts) grown, harvested, packed, and held for human consumption. The PSR specifically applies to certain fru its and
vegetables that are expected to be consumed without being cooked or otherwise prepared in a method that decreases the
presence of harmful microbes.
FSMA gives FDA the authority to conduct surveillance inspections on farms. Through a cooperative ag reement with the
National Association of State Departments of Agriculture (NASDA), FDA shares in -person inspectional authority of
domestic farms with states (foreign farms are inspected by FDA only); however, the autonomy of enforcement held by each
state has eroded the ability of FDA and NASDA to collect, analyze, and communicate inspection results. Some in Congress
have questioned whether implementation delays and inconsistent interpretation of PSR requirements between FDA and state
inspectional authorities are adversely affecting produce safety. If FDA and NASDA were to build a central database, it could
allow for consistent information sharing among state and federal authorities.
FDA has dispersed more than $112 million to NASDA via the State Produce Implementation Cooperative Agreement
Program (State CAP) in a package deal to conduct inspections and provide educational resources to farmers. In addition to
the State CAP, FDA collaborates with other government and nongovernment partners to develop programs that foster PSR
implementation through education. FDA’s partnerships with organizations such as the U.S. Department of Agriculture’s
National Institute of Food and Agriculture (USDA-NIFA), Association of Food and Drug Officials (AFDO), and university
extension services provide a scaffold to accomplish education and training goals established under PSR implementation.
Compliance dates for the FSMA rules are being phased in according to the sales of each business. 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 beneath the $25,000
monetary threshold are exempt from the PSR and do not have to implement FSMA standards or maintain paperwork to prove
their standing as exempt. In May 2019, FDA extended water quality-related compliance dates by an additional two years past
their original compliance dates due to continued stakeholder feedback questioning the adequacy of water testing
requirements. As of January 2020, all farms that grow produce subject to the PSR were to be in compliance with the
requirements. Notwithstanding changes enacted as part of FSMA, large-scale foodborne illness outbreaks related to fresh
produce continue to occur, according to FDA data.
As foodborne illness outbreaks continue, some question the effectiveness of FDA’s food safety implementation of FSMA.
FDA’s repeated delays in fully implementing key FSMA produce standards point to several possible contributing factors.
FDA’s authority to conduct inspections on farms and annual reporting requirements is limited compared with its authority to
carry out these activities in food facilities. FDA also has postponed compliance with certain key PSR requirements and has
not fully implemented FSMA’s traceability requirements for high-risk foods. Additionally, the lack of coordination over
inspection data between FDA and state and local authorities, which often bear mos t of the responsibility for inspecting farms
and food facilities within their jurisdictions, may lead to inconsistent implementation o f rule requirements on farms . A future
consideration for Congress could include expanding FDA’s inspectional and reporting authorities on farms, thus limiting
exemptions from the traceability rule. Congress could also consider authorizing FDA and states to build a unified farm
registry and inspection database.
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Produce Safety: Requirements, Implementation, and Issues for Congress

Introduction
The consumption of fresh and minimal y processed produce—fruits, vegetables, nuts, and
sprouts—has been associated with a series of foodborne il ness 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 111th Congress passed FSMA in response to changes in the global food system and an
understanding of foodborne il ness 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, scientifical y 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 il ness outbreaks. Pathogens—bacteria, viruses, and other biological hazards—
are the leading cause of foodborne il nesses. Pathogens may be found in foods of al 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 “kil ” step.
The Centers for Disease Control and Prevention (CDC) define a foodborne disease outbreak as
occurring when two or more people get the same il ness from the same contaminated food or
drink.4 Based on previous CDC outbreak investigations, microbial hazards associated with

1 See Centers for Disease Control and Prevention (CDC), “Foodborne Germs and Illnesses,” at https://www.cdc.gov/
foodsafety/foodborne-germs.html.
2 See, for example, Food Safety News, “Rep. DeLauro says she’s had enough with FDA’s delays in water quality
enforcement ,” February 15, 2019, at https://www.foodsafetynews.com/2019/02/rep-delauro-says-shes-had-enough-
with-fdas-delays-in-water-quality-enforcement/.
3 See Food and Drug Administration (FDA), “Standards for the Growing, Harvesting, Packing, and Holding of Produce
for Human Consumption,” 80 Federal Register 74353, November 27, 2015 (hereinafter FDA, PSR Final Rule, 80
Federal Register 74353, 2015).
4 See CDC, “Frequently Asked Questions: About the Foodborne Disease Outbreak Surveillance System (FDOSS),” at
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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 il nesses
linked to al items of produce is approximately $2.5 bil ion annual y.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.
Table 1. Selected Recurring Foodborne Disease Outbreaks, 2011-2020
Produce
Confirmed
Hospitalizations
Year
Commodity
Pathogen
Illnesses
(Deaths)
2020
Bagged Salad Mix
Cyclospora cayatenensis
701
38

Sprouts (clover)
E. coli O103
51
3
2019
Basil
Cyclospora cayatenensis
241
6

Salad Mix
E. coli O157:H7
10
4

Romaine Lettuce
E. coli O157:H7
167
85

Papaya
Salmonel a Uganda
81
27
2018
Leafy Greens
E. coli O157:H7
25
9 (1)

Leafy Greens
E. coli O157:H7
210
96 (5)

Romaine Lettuce
E. coli O157:H7
62
25

Vegetable Trays
Cyclospora cayatenensis
250
8

Salad Mix
Cyclospora cayatenensis
511
24

Sprouts (type
Salmonel a Montevideo
10
0
unspecified)
2017
Papaya
Various Salmonel a strains
251
5 (1)

Leafy Greens
E. coli O157:H7
25
9 (1)
2016a
Cilantro (suspect)
Cyclospora cayatenensis
384
NR

Sprouts (alfalfa)
Salmonel a Reading and Salmonel a Abony
36
7

Sprouts (alfalfa)
E. coli O157
11
2

Sprouts (alfalfa)
Salmonel a Muenchen and Salmonel a
26
8
Kentucky

https://www.cdc.gov/fdoss/faq.html.
5 See CDC, “ How Food Gets Contaminated – T he Food Production Chain,” at https://www.cdc.gov/foodsafety/
production-chain.html.
6 FDA, Standards for the Growing, Harvesting, Packing and Holding of Produce for Human Consumption , Final
Regulatory Im pact Analysis, pp. 53-54, at https://www.fda.gov/media/94153/download.
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Produce Safety: Requirements, Implementation, and Issues for Congress

Produce
Confirmed
Hospitalizations
Year
Commodity
Pathogen
Illnesses
(Deaths)

Packaged Salads
Listeria monocytogenes
19
19 (1)
2015
Cilantro (suspect)
Cyclospora cayatenensis
546
21

Cucumbers
Salmonel a Poona
907
204 (6)
2014
Cucumbers
Salmonel a Newport
275
34 (1)

Sprouts (bean)
Salmonel a Enteritidis
115
19

Sprouts (bean)
Listeria monocytogenes
5
5 (2)

Cilantro
Cyclospora cayatenensis
304
7

Sprouts (clover)
E. coli O121
19
7
2013
Ready-to-Eat Salads
E. coli O157:H7
33
7

Salad Mix, Cilantro
Cyclospora cayatenensis
631
49

Cucumbers
Salmonel a Saintpaul
84
17
2012
Spinach, Spring Mix
E. coli O157:H7
33
13

Mangoes
Salmonel a Braenderup
127
33

Cantaloupe
Salmonel a Typhimurium and Salmonel a
261
94 (3)
Newport

Sprouts (clover)
E. coli O26
29
7
2011
Romaine Lettuce
E. coli O157:H7
58
33

Cantaloupe
Listeria monocytogenes
147
143 (33)

Cantaloupe
Salmonel a Panama
20
3

Papaya
Salmonel a Agona
106
10

Sprouts (alfalfa, spicy) Salmonel a Enteritidis
25
3
Sources: Congressional Research Service (CRS), using data from Food and Drug Administration (FDA),
“Outbreaks of Foodborne Il nesses,” at https://www.fda.gov/food/recal s-outbreaks-emergencies/outbreaks-
foodborne-il ness; and Centers for Disease Control and Prevention (CDC), “List of Selected Multistate
Foodborne Outbreak Investigations,” at https://www.cdc.gov/foodsafety/outbreaks/multistate-outbreaks/
outbreaks-list.html.
Notes: Deaths appear in parentheses, if applicable.
NR = not reported.
a. Beginning in 2016, key FDA Food Safety Modernization Act (FSMA; P.L. 111-353) rules applicable to fresh
produce entering the distribution chain from farms, packinghouses, fresh-cut facilities, and mixed-type
facilities went into effect. These include the Standards for Growing, Harvesting, Packing and Holding
Produce for Human Consumption (PSR), Preventive Controls for Human Food rule (PCHF; 21 C.F.R. §117),
Foreign Supplier Verification Program (FSVP; 21 C.F.R. §1), Intentional Adulteration rule (IA; 21 C.F.R.
§121), Sanitary Transport of Food rule (ST; 21 C.F.R. §1). FSMA was enacted in 2011.
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 il ness 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

7 T ravis Minor et al., Food Safety Requirements for Produce Growers: Retailer Demands and the FDA Food Safety
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Produce Safety: Requirements, Implementation, and Issues for Congress

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 sel ing produce with a history of
foodborne il ness 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 domestical y produced and imported products. Selected provisions that broadly
address produce are shown in the text box titled “Selected Produce-Related FSMA Provisions,”
below.

Modernization Act, U.S. Department of Agriculture (USDA), Economic Information Bulletin no. 206, April 2019, at
https://www.ers.usda.gov/webdocs/p ublications/92761/eib-206.pdf?v=2999.6.
8 FDA, 2020 Leafy Greens STEC Action Plan, last updated March 2020, at https://www.fda.gov/food/foodborne-
pathogens/2020-leafy-greens-stec-action-plan.
9 See Fresh Express, Fresh Express Releases Blue-Ribbon Panel Interim Report on the Prevention of Foodborne
Cyclospora Outbreaks, June 5, 2019, at https://www.freshexpress.com/blue-ribbon-panel-report ; and Frank Yiannas
and Monica Parise, M.D., “ CDC Develop Robust Strategy to Prevent Illnesses Caused by Cyclospora, FDA,” 2019, at
https://www.fda.gov/news-events/fda-voices/fda-cdc-develop-robust-strategy-prevent -illnesses-caused-cyclospora.
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Selected Produce-Related Provisions in FSMA (P.L. 111-353)
Inspections of Records (§101)

Al ows the Food and Drug Administration (FDA) to inspect records related to the “manufacture, processing,
packing, distribution, receipt, holding, or importation” of certain foods and feed.
Registration of Food Facilities (§102)

Requires food facilities be subject to biennial registration renewal; FDA may suspend a facility’s registration in
certain cases.
Hazard Analysis & Risk-Based Preventive Controls (§103)

Requires FDA to establish mandatory preventive controls for food facilities, except for “smal business” and
“very smal business.”
Standards for Produce Safety (§105)

Requires FDA to establish mandatory minimum standards for the safe production and harvesting of fruits and
vegetables, except for “smal business” and “very smal business.”
Targeting of Inspection Resources (§201)

Requires FDA to identify high-risk facilities, increase the frequency of inspection of domestic and foreign
facilities, identify and conduct inspections at ports of entry, and improve interagency coordination and
cooperation.
Tracking and Tracing Food, Records (§204)

Requires FDA to establish pilot projects to improve traceability of foods and establish additional recordkeeping
requirements for certain “high-risk foods.”
Surveillance (§205)

Requires the Centers for Disease Control and Prevention to enhance foodborne il ness surveil ance systems
and conduct an assessment of state and local food safety and defense capacities.
Foreign Supplier Verification Program (FSVP, §301)

Requires FDA to establish a program whereby importers provide assurances that each foreign supplier is in
compliance with applicable food safety requirements.
Authority to Require Import Certifications for Food (§303)

FDA may require certifications for imported food based on food safety risk.
Inspection of Foreign Food Facilities (§306)

FDA may make arrangements and agreements with foreign governments to facilitate the inspection of foreign
food facilities.
Accreditation of Third-Party Auditors (§307)

Requires FDA to establish a system for the recognition of accreditation bodies that accredit third -party
auditors to certify that eligible entities meet the applicable food safety requirements.
For more information, see CRS Report R43724, Implementation of the FDA Food Safety Modernization Act (FSMA, P.L.
111-353).
At the farm production level, FSMA principal y 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.

10 FDA, PSR Final Rule, 80 Federal Register 74353, 2015.
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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 wil cost farms an average of
approximately $10,500 annual y.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 minimal y 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 smal farms (those for which the average annual monetary value of produce sold during the
previous three-year period is no more than $250,000) general y 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”).

11 FDA, PSR Final Rule, 80 Federal Register 74353, 2015, p. 74530. Estimates of domestic produce and sprout farms
are from USDA, National Agricultural Statistics Service (NASS), 2012 Census of Agriculture.
12 Estimated average cost of implementation is approximately $2,900 for very small farms; $15,300 for small farms;
and $28,500 for medium and large farms. T he average across the three farm sizes is approximately $10,500 annually.
See footnote 6.
13 Listed at 21 C.F.R. §112.2(a)(1).
14 21 C.F.R. §112.4-5 describes Standards for Growing, Harvesting, Packing and Holding Produce for Human
Consumption (Produce Safety Rule, or PSR) and monetary threshold values.
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Table 2. Selected PSR Compliance Dates
Compliance
Date for
Water-
Compliance
Retention of
Compliance
Related
Date for
Records
Compliance
Date for Most
Compliance
Qualified
Supporting a
Date for
Other
Date (Subpart
Exemption
Qualified
Business Size
Sprouts
Produce
E)
Labeling
Exemption
Businesses with
Jan. 26, 2017
Jan. 26, 2018
Jan. 26, 2022
Jan. 1, 2020
Jan. 26, 2016
Annual Produce
Sales Over
$500,000
Smal
Jan. 26, 2018
Jan. 28, 2019
Jan. 26, 2023
Jan. 1, 2020
Jan. 26, 2016
($250,000-
$500,000)
Very Smal
Jan. 28, 2019
Jan. 27, 2020
Jan. 26, 2024
Jan. 1, 2020
Jan. 26, 2016
($25,000-
$250,000)
Exempt
(<$25,000)
Not applicable
Source: See FDA, “FSMA Compliance Dates,” at https://www.fda.gov/food/food-safety-modernization-act-fsma/
fsma-compliance-dates#Produce_Safety. Additional FSMA compliance dates also can be found at this site.
Note: PSR = Standards for Growing, Harvesting, Packing and Holding Produce for Human Consumption .
Traceability and Surveillance
In FSMA, Congress also addressed food traceability (§204, 21 U.S.C. §2223) and surveil ance
(§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 il ness surveil ance 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.

15 See FDA, “ Implementation of the FDA Food Safety Modernization Act Provision Requiring FDA T o Establish Pilot
Projects and Submit a Report to Congress for the Improvement of T racking and T racing of Food; Request for
Comments and for Information,” 78 Federal Register 14309, April 4, 2013, at https://www.federalregister.gov/
documents/2013/03/05/2013-04997/implementation-of-the-fda-food-safety-modernization-act-provision-requiring-fda-
to-establish-pilot .
16 FDA, “ New Era of Smarter Food Safety Blueprint ,” at https://www.fda.gov/food/new-era-smarter-food-safety/new-
era-smarter-food-safety-blueprint .
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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 national y and international y 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.

17 FDA, “New Era of Smarter Food Safety Blueprint.”
18 FDA, New Era of Smarter Food Safety Blueprint: The First 100 Days, 2020, at https://www.fda.gov/media/143346/
download.
19 21 C.F.R. §117 replaced 21 C.F.R. §110 on September 2015. See FDA, “ Current Good Manufacturing Practice,
Hazard Analysis, and Risk-Based Preventive Controls for Human Food,” 80 Federal Register 55907, September 17,
2015.
20 FDA, Guidance for Industry: Guide to Minimize Microbial Food Safety Hazards of Fresh -cut Fruits and Vegetables,
February 2008, at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-industry-
guide-minimize-microbial-food-safety-hazards-fresh-fruits-and-vegetables.
21 USDA, “Good Agricultural P ractices (GAP) & Good Handling Practices (GHP),” at https://www.ams.usda.gov/
services/auditing/gap-ghp.
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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.
Selected Definitions from the Produce Safety Rule (PSR)
Agricultural Water—water used in covered activities on covered produce where water is intended to, or is
likely to, contact covered produce or food contact surfaces, including water used in growing activities (including
irrigation water applied using direct water application methods, water used for preparing crop sprays, and water
used for growing sprouts) and in harvesting, packing, and holding activities (including water used for washing or
cooling harvested produce and water used for preventing dehydration of covered produce).
Biological Soil Amendment of Animal Origin—a biological soil amendment which consists, in whole or in
part, of materials of animal origin, such as manure or non-fecal animal byproducts including animal mortalities, or
table waste, alone or in combination. The term biological soil amendment of animal origin does not include any form
of human waste.
Covered activity—growing, harvesting, packing, or holding covered produce on a farm. Covered activity
includes manufacturing/processing of covered produce on a farm, but only to the extent that such activities are
performed on raw agricultural commodities and only to the extent that such activities are within the meaning of

22 Popular auditing standards for fresh fruit and vegetable producers include those from Global Food Safety Initiative
(GFSI), Safe Quality Food (SQF), and International Organization for Standardization (ISO). T he audits are typically
conducted by certified independent consultants. See, for example, GFSI, “ Certification,” at https://mygfsi.com/how-to-
implement/certification/; SQF, “ How to Get Certified,” at https://www.sqfi.com/how-to-get-certified/; and ISO, “ ISO
22000: Food Safety Management ,” at https://www.iso.org/iso-22000-food-safety-management.html.
23 See the California Leafy Greens Marketing Agreement (CA-LGMA) website at https://lgma.ca.gov/ and the Arizona
Leafy Greens Marketing Agreement (AZ-LGMA) website at https://www.arizonaleafygreens.org/.
24 21 C.F.R. §112.1-5 (Subpart A: General Provisions) describes requirements for farming operations to be subject to
the PSR.
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farm as defined in this chapter. Providing, acting consistently with, and documenting actions taken in compliance
with written assurances as described in §112.2(b) are also covered activities. This part does not apply to activities
of a facility that are subject to part 117 of this chapter.
Covered produce—produce that is subject to the requirements of this part in accordance with §§112.1 and
112.2. The term covered produce refers to the harvestable or harvested part of the crop.
Farm—
(i) Primary Production Farm. A Primary Production Farm is an operation under one management in one general
(but not necessarily contiguous) physical location devoted to the growing of crops, the harvesting of crops,
the raising of animals (including seafood), or any combination of these activities. The term farm includes
operations that, in addition to these activities,
(A) Pack or hold raw agricultural commodities;
(B) Pack or hold processed food, provided that al processed food used in such activities is either
consumed on that farm or another farm under the same management, or is processed food identified in
paragraph (i)(C)(2)(i) of this definition; and
(C) Manufacture/process food, provided that
(1) Al food used in such activities is consumed on that farm or another farm under the same
management; or
(2) Any manufacturing/processing of food that is not consumed on that farm or another farm under
the same management consists only of
(i) Drying/dehydrating raw agricultural commodities to create a distinct commodity (such as
drying/dehydrating grapes to produce raisins), and packaging and labeling such commodities,
without additional manufacturing/processing (an example of additional
manufacturing/processing is slicing);
(ii) Treatment to manipulate the ripening of raw agricultural commodities (such as by treating
produce with ethylene gas), and packaging and labeling treated raw agricultural commodities,
without additional manufacturing/processing; and
(iii) Packaging and labeling raw agricultural commodities, when these activities do not involve
additional manufacturing/processing (an example of additional manufacturing/processing is
irradiation); or
(i ) Secondary Activities Farm. A Secondary Activities Farm is an operation, not located on a Primary Production
Farm, devoted to harvesting (such as hul ing or shel ing), packing, and/or holding of raw agricultural
commodities, provided that the Primary Production Farm(s) that grows, harvests, and/or raises the majority
of the raw agricultural commodities harvested, packed, and/or held by the Secondary Activities Farm owns,
or jointly owns, a majority interest in the Secondary Activities Farm. A Secondary Activities Farm may also
conduct those additional activities al owed on a Primary Production Farm in paragraphs (i)(B) and (C) of this
definition.
Mixed-type facility—an establishment that engages in both activities that are exempt from registration under
section 415 of the Federal Food, Drug, and Cosmetic Act and activities that require the establishment to be
registered. An example of such a facility is a farm mixed-type facility, which is an establishment that is a farm, but
that also conducts activities outside the farm definition that require the establishment to be registered.
Raw agricultural commodity—21 U.S.C. §321(r)—The term raw agricultural commodity means any food in its
raw or natural state, including al fruits that are washed, colored, or otherwise treated in their unpeeled natural
form prior to marketing.
For a ful list of statutory definitions related to the PSR, see 21 C.F.R. §112.3.
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 specifical y identifies an exhaustive list of
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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; dil (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 wel 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 al 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 stil 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.

25 Rarely consumed raw (RCR) produce refers to fruits and vegetables that are almost always cooked before being
consumed. RCR produce therefore, is intended to mean those produce commodities that are almost always eaten only
after being cooked (i.e., heat treated in some form). T he RCR produce list was developed using survey data from the
National Health and Nutrition Examination Survey/What We Eat in America (NHANES/WWEIA). FDA, FDA Fact
Sheet, Produce Safety Rule (21 CFR 112): “Rarely Consumed Raw” Produce,” at https://www.fda.gov/media/107445/
download.
26 See “Selected Definitions from the Produce Safety Rule” textbox in “ Farms Subject to the Produce Safety Rule.”
27 RCR is an exhaustive list of produce that may be changed only by new rulemaking. 21 C.F.R. §112.1-2.
28 21 C.F.R. §117.
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Table 3. Selected Produce Safety Rule Farm Classifications
Operational
Farming
Monetary
Qualified
Farm Type
Structure
Activities
Threshold
Exemptions
Primary

One general

Growing,

Farms with >

Farms with >
Production
physical location
harvesting,
$25k produce
$500k food

packing, holding
sales (three-
sales (three-

Under one
management
raw agricultural
year rol ing
year rol ing
commodities
basis, adjusted
basis, adjusted

for inflation)
for inflation)

Raising animals
subject to the
subject to

Certain
Produce Safety
modified
manufacturing
Rule (PSR)
requirements
activities
Secondary

Not located on a

Harvesting,

Farms with >

Farms with >
Activities
primary production
packing, holding
$25k produce
$500k food
farm
raw agricultural
sales (three-
sales (three-

Majority owned
commodities
year rol ing
year rol ing
(>50%) by the

Manufacturing
basis) subject
basis, adjusted
primary production
activities
to the PSR
for inflation)
farm where raw
al owed on
subject to
agricultural
primary
modified
commodities are
production
requirements
grown/harvested or
farms
animals are raised
Source: CRS using the PSR. See FDA, “Standards for the Growing, Harvesting, Packing, and Holding of Produce
for Human Consumption,” 80 Federal Register 74353, November 27, 2015 (hereinafter FDA, PSR Final Rule, 80
Federal Register 74353, 2015). Also available at FDA, “FSMA Final Rule on Produce Safety,” at
https://www.fda.gov/food/food-safety-modernization-act-fsma/fsma-final-rule-produce-safety.
Notes: Manufacturing may include activities such as drying, fumigating, and labeling if the activities do not
destroy the intact nature of the produce commodity (e.g., slicing). See 21 C.F.R. §112.3. Produce sales
calculations are not limited to produce subject to PSR requirements. Food sales calculations are not limited to
produce sales but are based on al food sold.
Withdrawal of a Qualified Exemption
A farm’s qualified exemption may be withdrawn if there is an active investigation of an outbreak
of foodborne il ness 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, recal , 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 il ness.
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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.
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Agricultural Water
FDA’s produce safety regulations require al 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 original y 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 il ness. Some types of pathogenic (il ness-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 al owed 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.

29 21 C.F.R. §112.41-50 describes requirements for PSR, Subpart E: Agricultural Water.
30 21 C.F.R. §112.3 provides the agricultural water definition.
31 T he average amount of E. coli in agricultural water is known as the geometric mean (GM). T he variable quantity of
E. coli in agricultural water is known as the statistical threshold value (ST V). Water quality can vary, for example, due
to environmental changes, such as heavy rainfall. T he GM and ST V are intended to help farms understand the
microbial quality of agricultural water over time and determine a long-term strategy for use of water sources for
growing produce other than sprouts.
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Table 4. Selected Numerical Microbial Water Quality Criteria in the Produce Safety
Rule
Agricultural Water Source
Numerical Criteria
to Which Numerical
Criteria
Application
for Generic E. coli
Criteria Apply
No detectable E. coli
Certain harvest and post-
0 CFUa per 100 mL of
Municipal water,b
harvest uses of
agricultural water
groundwater, treated surface
agricultural water in
water (untreated surface water
which the water may
is prohibited for this use)
directly or indirectly
contact covered produce
or food contact surfaces
Geometric mean (GM)
Agricultural water that is
≤126 CFU per 100 mL
Municipal water, groundwater,
directly applied to
of agricultural water
treated surface water,
growing produce (other
untreated surface water
Statistical threshold
than sprouts)
≤410 CFU per 100 mL
value (STV)
agricultural water
Source: CRS using the PSR. FDA, PSR Final Rule, 80 Federal Register 74353, 2015; and FDA, “FSMA Final Rule on
Produce Safety,” at https://www.fda.gov/food/food-safety-modernization-act-fsma/fsma-final-rule-produce-safety.
Notes: The average amount of E. coli in agricultural water is known as the geometric mean (GM). The variable
quantity of E. coli in agricultural water is known as the statistical threshold value (STV). Water quality can vary,
for example, due to environmental changes, such as heavy rainfal . The GM and STV are intended to help farms
understand the microbial quality of agricultural water over time and determine a long-term strategy for use of
water sources for growing produce other than sprouts.
a. CFU = colony forming units; mL = mil iliter.
b. Municipal water refers to water control ed, tested, and/or delivered by any federal, state, or local public
works system.
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 il nesses 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

32 See, for example, comment letter from Roger Johnson, president of the National Farmers Union, to Dr. Margaret
Hamburg, FDA’s food and drug commissioner, December 15, 2014, at https://downloads.regulations.gov/FDA-2011-
N-0921-1332/attachment_1.pdf; comment letter from Produce Marketing Association to FDA, December 15, 2014, at
https://downloads.regulations.gov/FDA-2011-N-0921-1331/attachment_1.pdf; and comment letter from Western
Growers to FDA, December 15, 2014, at https://downloads.regulations.gov/FDA-2011-N-0921-1409/attachment_1.pdf.
33 See FDA, “Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption;
Extension of Compliance Dates for Subpart E,” 84 Federal Register 9706, March 18, 2019, p. 9710.
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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.
BSAAO Microbiological Hazards
Soil amendments are physical, chemical, or biological components mixed into topsoil to promote healthy plant
growth. They function in numerous ways—for example, they may change the pH of soil or supply nutrients. Soil
amendments made from animal sources, such as animal waste (raw manure) or compost made from animal-
derived materials, including animal waste, animal carcasses, feathers, and bones, are referred to as biological soil
amendments of animal origin (BSAAOs). BSAAOs may contain bacterial pathogens (e.g., Salmonel a spp., E. coli) and
various other pathogens, such as parasites (e.g., Cryptosporidium parvum), which may infect humans. BSAAOs do
not include any form of human waste; 21 C.F.R. §112.53 states that the use of human waste is prohibited for
growing covered produce, except sewage sludge biosolids used in accordance with the requirements of 40 C.F.R.
part 503, subpart D, or equivalent regulatory requirements.
Farms monitor soil nutrient and moisture levels to determine when to apply soil amendments (including BSAAOs),
which can come into contact with fruits or vegetables. The application method and timing can determine if
BSAAOs that contain raw, untreated materials or improperly treated materials could contaminate produce.
Material that does not contain any animal waste is far less likely to harbor these food safety hazards at microbial
populations that reasonably can be expected to lead to severe adverse health consequences or death. FDA,
therefore, concludes that the likelihood of contaminating produce by use of biological soil amendments that do
not contain animal waste or human waste carrying human pathogens (e.g., yard trimmings, cul ed fruit and
vegetables) is low. Thus, requirements in the Produce Safety Rule focus on BSAAOs.
Sources: CRS, using various sources, including FDA, “Standards for the Growing, Harvesting, Packing, and
Holding of Produce for Human Consumption,” 78 Federal Register 3576, January 16, 2013 (see 21 C.F.R. §112.53);
and Jon Traunfeld and El en Nibali, Soil Amendments and Fertilizers: Fertilizing Guidelines Included by Plant Group,
University of Maryland Extension, Home & Garden Information Center, 2013, p. 1.
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

34 FDA, “ FDA Announces New Protocol for the Development and Registration of T reatments for Preharvest
Agricultural Water,” press release, July 30, 2020, at https://www.fda.gov/news-events/press-announcements/fda-
announces-new-protocol-development-and-registration-treatments-preharvest-agricultural-water.
35 21 C.F.R. §112.55 describes biological soil amendments of animal origin (BSAAO) microbial standards.
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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 il nesses, 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.

36 21 C.F.R. §112.54 describes BSAAO treatment processes.
37 21 C.F.R. §112.51-60 describes requirements for PSR, Subpart F: Biological Soil Amendments of Animal Origin and
Human Waste.
38 Five to ten years of the PSR publication date of November 27, 2015. See FDA, PSR Final Rule, 80 Federal Register
74353, 2015.
39 National Advisory Committee on Microbiological Criteria for Food, Microbiological Safety Evaluations and
Recom m endations on Sprouted Seed, November 1999, at https://pubmed.ncbi.nlm.nih.gov/10733245/.
40 FDA, Compliance with and Recommendations for Implementation of the Standards for the Gro wing, Harvesting,
Packing, and Holding of Produce for Hum an Consum ption for Sprout Operations: Guidance for Industry , Draft
Guidance, January 2017, at https://www.fda.gov/media/102430/download.
41 21 C.F.R. §112.141-150 describes requirements for PSR, Subpart M: Sprouts.
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 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, al covered farms
must visual y examine the growing area for animal contamination and al 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 il 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 il 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.

42 See FDA, “ FSMA Final Rule on Produce Safety, Key Requirements, Sprouts,” at https://www.fda.gov/food/food-
safety-modernization-act-fsma/fsma-final-rule-produce-safety.
43 21 C.F.R. §112.81-84 describes requirements for PSR, Subpart I: Domesticated and Wild Animals.
44 21 C.F.R. §112.21-30, 31-33 describes requirements for PSR, Subpart C: Personal Qualifications and T raining and
Subpart D: Health and Hygiene.
45 21 C.F.R. §112.32 (a) describes hygienic practices workers must use per the PSR.
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 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 wel 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 Al iances 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 wel 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 wel 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 general y scheduled with the farm owner or operator
in charge via a phone cal . Unannounced inspections are rare but may occur in limited
circumstances.48

46 See FDA, “FSMA Final Rule on Produce Safety, Key Requirements, Worker T raining and Health and Hygiene,” at
https://www.fda.gov/food/food-safety-modernization-act-fsma/fsma-final-rule-produce-safety.
47 21 C.F.R. §112.121-140 describes requirements for PSR, Subpart L: Equipment T ools, Buildings, and Sanitation.
48 FDA, “ What to Expect During a Regulatory Inspection,” fact sheet, at https:/www.fda.gov/media/124328/download.
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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 al ow 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 al
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 al ows 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.

49 T he On-Farm Readiness Review (OFRR) program is a voluntary, nonregulatory review of food safety protocols
performed at the request of individual farms. For more information, see National Association of State Departments of
Agriculture (NASDA), “ On-Farm Readiness Review,” at https://www.nasda.org/foundation/food-safety-cooperative-
agreements/on-farm-readiness-review.
50 FDA, “ Coronavirus (COVID-19) Update: FDA prepares for resumption of domestic inspections with new risk
assessment system,” press release, July 10, 2020, at https://www.fda.gov/news-events/press-announcements/
coronavirus-covid-19-update-fda-prepares-resumption-domestic-inspections-new-risk-assessment -system.
51 FDA, FY2021 Justification of Estimated of Appropriations Com mittees, 2020, at https://www.fda.gov/media/135078/
download.
52 FSMA, §210.
53 FDA, “Funding Opportunity Announcement (FOA),” 2016, at https://grants.nih.gov/grants/guide/pa-files/PAR-16-
137.html.
54 U.S. states and territories are classified into five tiers of funding ceilings based on the number of farms growing
covered produce within the jurisdiction. T his tiered system establishes funding ceilings proportional to the applicant’s
jurisdictional produce volume.
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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 wil 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 al food safety inspection data, which would al ow 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 wil depend upon annual appropriations and awardee performance. The
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total funding available for years one through four (FY2017-FY2020) amounted to approximately
$112 mil ion.55
PSR standards apply equal y 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 al ergen 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 successful y complete verification activities before importing foods. FDA began
routine FSVP inspection of importers of produce from large farms in fal 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 fal outside of the current farm definition conduct activities that are typical y
conducted on farms (Table 5). For example, some operations that might otherwise qualify as

55 See FDA, “State Produce Implementation Cooperative Agreement Program (CAP),” at https://www.fda.gov/federal-
state-local-tribal-and-territorial-officials/grants-and-cooperative-agreements/state-produce-implementation-
cooperative-agreement-program-cap.
56 See FDA, Am I Subject to FSVP, November 13, 2015, at https://www.fda.gov/media/94281/download.
57 See FDA “FSVP and Produce Inspections,” at https://www.fda.gov/inspections-compliance-enforcement-and-
criminal-invest igations/inspection-references/fsvp-and-produce-inspections.
58 FDA, Policy Regarding Certain Entities Subject to the Current Good Manufacturing Practice and Preventive
Controls, Produce Safety, and/or Foreign Supplier Verification Program s: Guidance for Industry, 2018, at
https://www.fda.gov/media/110023/download (hereafter FDA’s Enforcement Discretion Guidance); and FDA,
“Enforcement Discretion for Certain FSMA Provisions,” fact sheet, 2018, at https://www.fda.gov/media/110052/
download (hereafter FDA’s Enforcement Discretion Fact Sheet).
59 FDA’s Enforcement Discretion Guidance covers certain entities or activities covered by the Current Good
Manufacturing Practice, Hazard Analysis, and Risk -Based Preventive Controls for Human and Animal food rules (PC
Human Food and PC Animal Food or CGMP & PC rules), Foreign Supplier Verification Programs rule (FSVP), and
the PSR.
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secondary activities farms do not because they do not meet the ownership requirement. In this
situation, they would be regulated under PCHF.
Table 5. Summary of Enforcement Policy with Regard to Human Food
Description of facilities and
Does enforcement apply for
activities conducted by the
human food preventive control
Does enforcement discretion
facilities
requirements?
apply for human food cGMPs?a
Facilities that would qualify as
Yes
No, for farm-related activities
secondary activities farms except
conducted on produce RACsb
for the ownership of the facility
Yes, for farm-related activities
conducted on nonproduce RACsc
Facilities that would qualify as farms
Yes
No, for coloring of produce RACs
if they did not color RACs
Yes, for coloring of nonproduce
RACs
Facilities that would qualify as

No, for produce RACs
secondary activities farms except
Yes
Yes, for nonproduce RACs
that they pack, package, label,
and/or hold processed food that
consists of only RACs that have
been dried/dehydrated to create a
distinct commodity such as dried
beans
Source: FDA, “Enforcement Discretion for Certain FSMA Provisions,” fact sheet, 2018, at https://www.fda.gov/
media/110052/download.
Notes:
a. cGMPs = current good manufacturing practices.
b. RACs = raw agricultural commodities.
c. Eggs are examples of nonproduce RACs.
According to FDA, stakeholders have chal enged the classification of establishments that both
fal outside of the current farm definition and conduct activities that are typical y 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 wil 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

60 Letter from United Fresh Produce Association et al. to Michael T aylor, FDA’s deputy commissioner for Foods and
Veterinary Medicine, and Dr. Stephen Ostroff, FDA Office of the Commissioner’s chief scientist, April 19, 2016, at
https://downloads.regulations.gov/FDA-2011-N-0921-19141/content.pdf.
61 21 C.F.R. §112.2(b)(3).
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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 smal businesses, including smal and medium-
sized farms, beginning farmers, social y disadvantaged farmers, smal processors, or smal fresh
fruit and vegetable merchant wholesalers, as wel 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 wil 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.

62 FDA’s Enforcement Discretion Fact Sheet.
63 Consumer Brands Association (CBA) (formerly the Grocery Manufacturers Association [GMA]), “GMA Industry
Impacts from Disclosure and Written Assurance Requirements,” 2017, at https://beta.regulations.gov/document/FDA-
2011-N-0921-19136.
64 FSMA, §209.
65 USDA’s National Institute of Food and Agriculture (USDA-NIFA), “ USDA-NIFA Food Safety Outreach Program,”
at https://nifa.usda.gov/food-safety-outreach-program.
66 Several grants are issued through the FDA, USDA-NIFA grants program. T he funding is made possible through
NIFA’s Agriculture and Food Research Initiative (AFRI) program. Congress established AFRI in the 2008 Farm Bill
and reauthorized it in the 2018 Farm Bill. T he program was reauthorized to be funded at $700 million a year. T he
Consolidated Appropriations Act, 2019, funds AFRI at $415 million. See H.R. 648; and USDA-NIFA, “ Agriculture
and Food Research Initiative (AFRI),” at https://nifa.usda.gov/program/agriculture-and-food-research-initiative-afri.
67 See FDA, “FSMA T raining,” at https://www.fda.gov/food/food-safety-modernization-act-fsma/fsma-
training#Establishing_the_National_Coordination .
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Table 6. Selected Key FDA Cooperative Agreements for Product Safety Rule
Education, Training, and Outreach
Organization
Program Objective
National Association of State Departments
Develop a set of best practices for implementation of the produce
of Agriculture (NASDA)
rule, including education and outreach activities to both regulators
and industry
USDA Agricultural Marketing Service (AMS)
Establish the Produce Safety Al iance to develop the standardized
and Cornel University
curriculum for producers of fruits and vegetables other than
sprouts
Illinois Institute of Technology’s Institute for
Establish the Sprouts Safety Al iance to develop the standardized
Food Safety and Health (IIT IFSH)
curriculum for sprout producers
University of Arkansas Indigenous Food and
Advance food safety through outreach, education and training to
Agriculture Initiative (IFAI)
Native American tribes
National Farmers Union via the Local Food
Enhance food safety through targeted outreach, education and
Safety Col aborative
training to local food producers and processors including
beginning and social y disadvantaged farmers, traditional farmers,
urban farmers, smal farmers and processors, and other supply-
chain participants.
University of Florida, Oregon State
Establish regional centers in the Southern, Western, North
University, Iowa State University, University
Central and Northeast regions of the country charged with
of Vermont and State Agricultural Col ege
understanding and communicating the landscape of training
opportunities available to target businesses in their region.
University of Maryland Joint Institute for
Coordinate and deliver international training programs
Food Safety and Applied Nutrition (JIFSAN)

Source: CRS using FDA, “FSMA Training,” at https://www.fda.gov/food/food-safety-modernization-act-fsma/
fsma-training.
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

68 FDA, Developing a Coordinated National Produce Safety Program , 2014, at https://federalreporter.nih.gov/Projects/
Details/?projectId=928912&ItemNum=NaN&totalItems=3846&searchId=b850241613a74a58962c0bd1a1edd5d4&
searchMode=Smart&page=67&pageSize=50&sortField=Ic&sortOrder=desc&filters=
$Agency;FDA$ProjectT ype;p&navigation=True.
69 NASDA, NASDA Model Produce Safety Implementation Framework, updated 2019, at https://s3.amazonaws.com/
nasda2/media/NASDA-Model-Produce-Safety-Implementation-Framework_2-22-2019.pdf?mtime=20190906154302.
70 See NASDA, “ About On-Farm Readiness Review,” at https://www.nasda.org/foundation/food-safety-cooperative-
agreements/on-farm-readiness-review#token=FFvwLvZzPLDbIonAziUjw8cJ_T PpbYL7 .
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FSMA.71 The National Farmers Union plans to conduct targeted outreach, education, and training
to local food producers and processors, including beginning and social y disadvantaged farmers,
traditional farmers, urban farmers, smal 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 Cornel
University, has established the Produce Safety Al iance (PSA).74 FDA also established the Sprouts
Safety Al iance (SSA) in collaboration with the Il inois 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 Al iance
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 fulfil
the training requirement by either successfully completing the Al iance 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 Cornel 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
Additional y, PIP has an active role in collaborating with international industry associations,

71 See FDA, “ FDA Announces New Round of Funding to Support FSMA Education, T raining and T echnical
Assistance: Constituent Update,” July 27 2020, at https://www.fda.gov/food/cfsan-constituent -updates/fda-announces-
new-round-funding-support -fsma-education-training-and-technical-assistance.
72 T he award for the local food producer cooperative agreement will be for $1,000, 000 for one year with the possibility
of an additional year of support contingent upon satisfactory performance and the availability of federal funding. For
more information, see National Farmers Union, “Local Food Safety Collaborative,” at https://nfu.org/farmsafety/local-
food-safety-collaborative/; and Department of Health and Human Services (HHS), “ Local Food Producer Outreach,
Education, and T raining to Enhance Food Safety an d FDA Food Safety Modernization Act (FSMA) Compliance,”
2019, at https://grants.nih.gov/grants/guide/rfa-files/RFA-FD-20-006.html.
73 T he award for the tribal cooperative agreement will be for $500,000 for one year with the possibility of an additional
year of support contingent upon satisfactory performance and the availability of federal funding. See HHS, “ Native
American T ribes Outreach, Education, and T raining to Enhance Food Safety and FSMA Compliance,” 2019, at
https://grants.nih.gov/grants/guide/rfa-files/RFA-FD-20-004.html.
74 FDA and USDA do not publicly publish funding data for the Product Safety Alliance (PSA); however, based on
articles from industry groups, PSA received roughly $1,150,000 for a three-year partnership established in 2010. PSA
continues to operate as a collaboration between Cornell University, FDA, and USDA to deliver training. See NSAC’s
blog, USDA, FDA, and Cornell University form Produce Safety Alliance, 2010, at https://sustainableagriculture.net/
blog/produce-safety-alliance/; and the PSA web page at https://producesafetyalliance.cornell.edu/.
75 Per 80 Federal Register 43095, FDA’s cooperative agreement with Illinois Institute of T echnology’s National Center
for Food Safety and T echnology provides roughly $5,000,000 to $7,000,000 annually to support research, education,
and outreach programs, including the Sprouts Safety Alliance.
76 For more on the Produce International Partnership for Education and Outreach (PIP) program, see University of
Maryland Joint Institute for Food Safety and Applied Nutrition (JIFSAN), “ Program Description,” at
https://jifsan.umd.edu/training/international/courses/pip/description.
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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 il ness 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 wel 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.
Additional y, 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 il ness 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 fal 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 specifical y collected

77 See FDA, “ Frequently Asked Questions on Systems Recognition for Foreign Governments,” at https://www.fda.gov/
food/international-interagency-coordination/frequently-asked-questions-systems-recognition-foreign-governments.
78 See Produce Marketing Association, “ Canada Import Requirements for U.S. Romaine Lettuce: Q&A,” at
https://www.pma.com/content/articles/canada-import-requirements-for-us-romaine-lettuce.
79 U.S. Government Accountability Office (GAO), High-Risk Series: Substantial Efforts Needed to Achieve Greater
Progress on High-Risk Areas, GAO-19-157SP, March 6, 2019, at https://www.gao.gov/products/GAO-19-157sp.
80 GAO, A National Strategy Is Needed to Address Fragmentation in Federal Oversight, GAO-17-74, January 2017, at
https://www.gao.gov/assets/690/682095.pdf. For related background, see CRS Report RS22600, The Federal Food
Safety System : A Prim er.
81 See FDA, “ Factors Potentially Contributing to the Contamination of Romaine Lettuce Implicated in the T hree
Outbreaks of E. coli O157:H7 During the Fall of 2019,” at https://www.fda.gov/food/outbreaks-foodborne-illness/
factors-potentially-contributing-contamination-romaine-lettuce-implicated-three-outbreaks-e-coli.
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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 116th Congress would have authorized FDA to request access to concentrated animal
feeding operations during foodborne il ness 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. Additional y, 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 fal 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

82 For purposes of Section 201, the term facility means a domestic facility or a foreign facility that is required to register
under 21 U.S.C. §350d. Per 21 U.S.C. §350d, facility does not include farms. Section 201 further sets facility
inspection frequencies, and it amends 21 U.S.C. §393 annual reporting to Congress.
83 FDA, “ Requirements for Additional T raceability Records for Certain Foods: Proposed Rule,” at
https://www.regulations.gov/document?D=FDA-2014-N-0053-0056.
84 FDA, “ Food T raceability List,” at https://www.fda.gov/food/food-safety-modernization-act-fsma/food-traceability-
list.
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Produce Safety: Requirements, Implementation, and Issues for Congress

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 sel s cucumbers to a
distributor who comingles produce from several other farms during repacking, the contaminated
cucumbers can potential y 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 general y 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 general y 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, potential y 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.

Author Information

Amber D. Nair

Analyst in Agricultural Policy

85 Per 21 C.F.R. §112.3, qualified end user, with respect to a food, means the consumer of the food (where the term
consumer does not include a business); or a restaurant or retail food establishment (as those terms are defined in
§1.227) that is located: (1) In the same State or the same Indian reservation as the farm that produced the food; or (2)
Not more than 275 miles from such farm.
86 FDA, “Registration of Food Facilities and Other Submissions,” at https://www.fda.gov/food/guidance-regulation-
food-and-dietary-supplements/registration-food-facilities-and-other-submissions.
87 GAO, FDA Continues to Evaluate and Respond to Business Concerns about the Produce Rule , GAO-18-85,
November 2017, at https://www.gao.gov/assets/690/688596.pdf.
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