Food Protection Trends - November/December 2023 - 469

The most frequent non-compliance issue observed under
this subpart was 112.140, the establishment and possession
of records that include the date and method of cleaning
and sanitizing of equipment used for growing sprouts and
harvesting, packing, or holding activities; and this subsection
is in relation to Subpart O as well. Nineteen (51%) of 37
non-compliance issues under this were related to growers
doing the work without documenting the information as per
the PSR. Specifically, not recording the date and method of
cleaning and sanitizing equipment used for covered activities.
Keeping records and documentation of information needed
including practices and corrective actions are significant for
regulatory agencies to determine whether proper procedures
were being followed and to take necessary actions if traced
back to a troublesome point (12).
Subpart O: Records
Subpart O specifies the general requirements for records,
including those required for training, agricultural water,
exemptions, cleaning, and sanitizing. This subpart also
includes requirements describing how records must be
established and maintained, including record retention,
storage, and verification, as well as official review and public
disclosure. Record keeping was a non-compliance issue that
appeared in other subparts in the current study's dataset. The
focal point of the records section is to document and monitor
tasks in the farming operation that reduce food safety risks
and to provide evidence of these tasks that satisfy the PSR.
Subpart O had the greatest number of non-compliance issues
observed (n = 78; 47.5%).
Subsection 112.161(a), for records required by the rule
must include the name and location of the farm, actual values
and observations obtained during monitoring, adequate
descriptions of covered produce, the location of a growing
area, and the date and time of the activity documented. In
addition, documents must be created when the activity is
performed and be accurate, legible, and indelible and be
dated and signed by the person who recorded the activity.
These activities represented the most frequent (n = 42) noncompliance
issues reported by TDA field specialists under
Subpart O. Notably, the date and time of the recorded activity
were missing from farming records. In some instances, boxes
were checked on cleaning and sanitizing; however, specific
concentration values (parts per million) were not included.
Field specialists also observed that activities were performed,
but not recorded, in real time. Subsection 112.161(b) had
the second most frequent number of non-compliance issues
(n = 35) under Subpart O, the subpart that requires that
supervisors or other responsible parties review, date, and sign
records within a reasonable time after the records are made.
These results indicate that although records are maintained
by large farms, they are not reviewed by a supervisor in an
adequate amount of time to allow for potential food safety
risks to be addressed. There was only one reported noncompliance
issue with subsection 112.166(a), which requires
that records of recorded activities be readily accessible during
the retention period for inspection and copying by the FDA
and within 24 h for records that are stored offsite. Overall,
these results showed that record keeping had the highest
number of non-compliance issues from the large farms
assessed, which spanned across multiple subparts of the PSR.
For example, the leading non-compliance issues reported
under subparts C and L were related to maintaining adequate
records that satisfy Subpart O of the PSR. Specifically, the
inclusion of the date, name, location, and review and sign-off
on documents by a supervisor was the major cause of noncompliance
issues from the on-farm assessments. In addition,
some subparts, such as Subpart C and Subpart L, maintained
adequate records, but lacked some key components such
as required trainings and specific information regarding the
methods used to clean and sanitize equipment.
Records are an important part of on-farm food safety risk
management because they keep track of measures directed
at minimizing the risk of known or reasonably foreseeable
hazards, identify a pattern of problems that increase the risk
of such hazards, and facilitate verification and compliance
with regulatory standards (29, 33). The struggle to adopt
or maintain record keeping practices is not unique to
produce farming operations and may stem from perception
or behavior issues. A previous study investigated the record
keeping behavior of small-scale poultry farmers in the Ga
East Municipality in Ghana and found that 46% of surveyed
farmers did not keep records because they did not find it
beneficial to them; 22% could not give a reason as to why
they did keep records; 14% complained of time constraints;
and 8% mentioned that they did not keep records because
of difficulty entering data due to stress, forgetfulness due to
deferred entries, hired personnel did not maintain adequate
records, and barriers related to lower levels of education
(26). Tokede et al. (28) conducted a two-part study in the
field of dentistry to determine (1) what information should
be included in dental records and (2) practitioner attitudes
and reasons why records are not accurately or completely
executed. The study concluded that the study participants
agreed on the importance of record keeping in general;
however, there was variability among participants regarding
the frequency they believed records should be maintained
and updated based on individual institutions, practitioner
preferences, and varying demands in patient care (28).
Notably, the study suggested that challenges in record
keeping may be attributed to a busy workplace setting in
which workers must balance multiple information sources
and competing tasks and suggest that the challenge may
be in finding a way to make record keeping more efficient,
complete and accurate and as least disruptive as possible to
the overall workflow (28).
Although record keeping is a requirement for FSMA
compliance, previous literature from various farming
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