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The FDA's stated approach to implementing the FSMA
PCHF Rule has been to " educate before and while we regulate. "
Inspectors often play an important role in interpreting
regulatory requirements specific to individual facilities (7).
Yet there are limits to the amount of one-on-one advice and
assistance inspectors can provide to food businesses given the
FSMA directive of inspection frequencies of a minimum of
once every 3 to 5 years depending on food risk classification
and history of violations (28). Constraints on inspector time
at each facility point to a need for food safety communicators
and regulators to work together to improve awareness of the
PCHF Rule and to provide advice and assistance as needed
or refer questions to others in the food safety community.
Motivation to address challenges and engage in PCHF
compliance
After SVS food processors are made aware of the PCHF
Rule and gained baseline knowledge of its requirements, they
face challenges associated with the costs of compliance (Fig.
1). Although SVS food processors and food safety communicators
cannot control the costs of compliance, they can
identify and emphasize the motivating factors that will foster
a personal commitment to adopt food safety practices and
accept the associated costs. Greater business opportunities
can act as an incentive, whereas fear of legal or regulatory
consequences can motivate internal commitment (34).
Costs for hiring consultants, training food safety workers,
and upgrading facilities and equipment are among the
most challenging barriers to PCHF compliance (Fig. 1).
Previous studies have shown that SVS food processors are
unmotivated to adopt food safety practices because they
consider the risks of enforcement related to noncompliance
to be low (22, 23). This is particularly true for SVS food
processors that have attested to the FDA that they are
qualified facilities because they are not required under the
PCHF Rule to develop and implement a food safety plan.
Yet long-term adoption of food safety practices can only
be successful if there is a written plan for identifying and
evaluating potential hazards and continuous reevaluation
of risks. In addition, food safety communicators observed
that SVS food processors' lack of understanding of financial
and business risks associated with noncompliance presents a
significant barrier to compliance (Fig. 1).
In addition to the costs of compliance identified in this
study (Fig. 1), previously reported challenges to develop
a food safety system include shortages of time, staff, and
equipment or facilities (2, 9). Despite the monetary challenges
that processors face, there are financial benefits to investing
in food safety. Most notably, the costs to develop and
implement a food safety system can be justified by protecting
against litigation (33) and maintaining or increasing market
access to retailers that may require a food safety plan (5, 22).
In addition to the practical benefits of engaging in PCHF
compliance, SVS food processors may be motivated to
invest in food safety because of a commitment to producing
safe foods. Consistent with the report from Bihn et al.
(5) that found personal commitment to producing a
safer food product was the most common motivation for
food producers to learn about food safety, food safety
communicators in the present study did not consider lack of
appreciation of the importance of producing safe foods to
be a challenge to PCHF compliance (Fig. 1). As a result, it is
vital for food safety communicators and regulators to educate
SVS food processors about how the PCHF Rule is designed
to improve food safety and that processors should take steps
to comply as part of their personal commitment.
Training improvement opportunities
The results in this study identified several opportunities
to improve training and educational resources based on
challenges related to content and delivery specific to SVS
food processors. The observed knowledge gaps and the
perception that some parts of the FSPCA PCHF curriculum
are very or extremely difficult show that SVS food processors
could benefit from additional training around both basic food
safety and sanitation standards and risk-based food safety
management approaches for producing safe foods (Tables 6
and 7). This and the reports of food safety communicators
that training materials can be both too advanced and too
general, not targeted to the specific needs of their products
and processes (Fig. 1), point to the diversity of participant
background knowledge and preparation needed to develop
risk-based management systems.
Respondents' perception of sanitation training highlights
SVS food processors' need for introductory training to
effectively understand and implement the FSPCA PCHF
curriculum. Most lead instructors consider every section
of the curriculum to be at least moderately difficult to
understand and implement, even the lowest-ranked section,
sanitation controls (Table 7). Yet sanitation training is the
second most highly recommended course in helping SVS
food processors comply with the PCHF Rule (Table 11). The
significant gap in the relative difficulty of sanitation training
compared with the perceived benefit to processors presents
an opportunity for additional training courses to meet
processor needs.
Food safety communicators and regulators agreed
that GMP training would be the most effective course in
helping processors to comply with the PCHF Rule (Table
11). It is also the most broadly applicable course among a
range of food businesses that may not be subject to the full
requirements of the PCHF Rule, and processors in past
studies have expressed greater interest in GMP training
than the FSPCA PCHF curriculum (3, 19, 21). Framing
GMP training as an effective on-ramping course can provide
fundamental training and increase processors' perception
that training is accessible and relevant. More generally,
Barone et al. (3) and Richard et al. (20) both commented
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