Food Protection Trends - November/December 2023 - 458

U.S. Food and Drug Administration (FDA) is to collaborate
with state partners across the country to minimize the risk
of foodborne illness associated with the consumption of
covered produce (34). Farms covered by the PSR will follow
specific regulations for production practices in 12 component
areas that then were generalized into 5 aspects: agricultural
water quality, soil amendments of animal origin, worker
health and hygiene, animal intrusion, and sanitary standards
(7).
The Centers for Disease Control and Prevention estimate
that each year 48 million people get sick, 128,000 are
hospitalized, and 3,000 die from foodborne diseases in
the United States (8). It is estimated that fresh produce
commodities accounted for nearly half of all domestically
acquired foodborne illnesses (46%) and were the second
highest cause of death related to foodborne illnesses (23%)
in the United States between 1998 and 2008 (20). Since
then, foodborne illness outbreaks have been associated with
fresh produce commodities such as leafy greens, peaches,
onions, bagged salad mix, mushrooms, clover sprouts, pre-cut
fruits, and whole fruits, to list a few, in just the past 3 years
(9). Between 2015 and 2020, the state of Texas experienced
711 outbreaks, >15,000 illnesses, and 17 deaths associated
with fresh produce (10); however, no documented outbreaks
in this state have been traced back directly to a farm in Texas.
Food safety interventions such as large-scale trainings,
educational extension courses, and suitable policymaking
specifically supporting farmers will be crucial in Good
Agricultural Practices (GAP)-related activities and FSMA
compliance (23). GAP is casted by a guide that was released
in 1998 by the FDA to reduce microbial hazards in the
growing, harvesting, packing, and storing of fresh fruits
and vegetables; instead of eliminating risks, it is focused on
reducing risks that may occur during the growing process,
including soil amendments, worker health and hygiene,
animal intrusion, and post-harvest cleaning and sanitation
practices (13). Produce growers, extension personnel,
university researchers, and local and federal governments
have been working in tandem for years to disseminate
relevant information and educational materials to growers
throughout the United States to increase compliance with
GAP and now with PSR (27). Among them are programs
such as the Produce Safety Alliance (PSA) that was
established to provide food safety training for fresh produce
growers to meet the regulatory requirements under FSMA
through a collaboration between Cornell University, the
U.S. Department of Agriculture, and the FDA (6, 13). As
part of the national effort, during on-farm inspections,
the aim is to " educate before and while we regulate " by
identifying opportunities to educate farmers about the PSR,
the supporting science, and the regulatory process before,
during, and after assessments (32).
Before initial assessments, the growers were provided
educational materials designed by the state department
458 Food Protection Trends November/December
of agriculture in conjunction with the FDA. Following
this, state programs designed tools specific to each state
focusing on state-specific challenges to include on-farm
outreach programs. The rule only establishes the minimum
requirements that are to be met and does not specify how the
expectations are to be met. This provides for flexibility for
covered farms regardless of type, size, geographical region,
and commodities to meet these requirements with the
resources available to them. Previous studies have sought to
identify challenges that farming operations may encounter
while working to become compliant with FSMA and the
PSR; however, there is a paucity of literature regarding statespecific
challenges with on-farm compliance under various
subparts listed throughout the PSR. Adalja and Lichtenburg
(1) conducted a national survey to determine the use of
food safety practices among produce growers in the United
States, but they highlight the need to focus on specific
types of farming operations in limited geographic areas to
fully grasp the issues that growers face in compliance with
the PSR. Hence, the overarching goal of the current study
was to determine areas where there were non-compliance
issues with the PSR associated with large farms in the state
of Texas. Specifically, the objectives of this study were to
(1) analyze on-farm assessments of food safety practices,
activities, and conditions specific to the PSR to identify
non-compliance issues among large farm produce growers
in the state of Texas; (2) identify patterns and underlying
issues that may have resulted in non-compliance issues to the
rule; and (3) determine the opportunity or need for training,
education, or the development of additional resources to
specifically address patterns and/or underlying issues of noncompliance.
MATERIALS
AND METHODS
In total, 69 large farms in the state of Texas were assessed
by field specialists from the Texas Department of Agriculture
(TDA) over a 16-month period. Large farms are defined
as farms that have exceeded $500,000 in average annual
produce sales over the course of a 3-year period adjusted for
inflation (29). The on-farm assessments began in October
2019 and continued until February 2021. No assessments
were conducted for 4 months between March 2020 and June
2020 because of the COVID-19 pandemic. All assessment
activities resumed in July 2020. Commodities produced
by these large farms included leafy greens, citrus, summer
squash, watermelons, cantaloupe, mushrooms, and tomatoes.
TDA field specialists conducted the on-farm assessments
by using 21 CFR Part 112 to determine non-compliance
issues by observations and then reported the data. The farm
assessments were conducted by reviewing the farm inventory
and identifying large farms that grew covered produce. The
farms were contacted, and a date and time were scheduled
for the field specialists to conduct assessments. During the
assessments, the field specialists reviewed farm activity first
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