causes of foodborne illness. The law becomes meaningful to the consumer during
these times because they have heard, read, seen, experienced, or responded to issues
related to the food they eat. They also generally agree with the rationale for the law,
and certain groups are monitoring how it is enforced. That is a strength of FSMA.
To some, however, the introduction of FSMA implies that the U.S. had a widespread problem with the safety of the foods that are sold and consumed in the
nation. And some expected the law to completely eliminate unsafe foods. Thus,
when an outbreak occurred, the farmer,
processor, wholesaler and retailer, and restaurant were often implicated as the most
probable source of the illness. The consumer may be minimally mentioned. This
unintended result may be construed as a
weakness of FSMA, but no law is absolute
or perfect. As trainers, we must communicate that food safety is a responsibility that
everyone must bear, from the grower and
harvester to the consumer. There are no exceptions.
Tatiana Koutchma: The weakness is that industry struggles with the interpretation
of FSMA rules that can be quite broad and not sufficiently detailed. The strength is
that industry is looking for new solutions or reconsidering and revising existing practices to comply with the rules. Often, industry is looking for long-term solutions and
is willing to invest time and resources. Another strength is that during the lengthy
rule-making process, FDA took the time to gather thousands of written comments
and meet with stakeholders in person.
FDA has acknowledged that FSMA is imposing costs on the food industry, but
it also makes the point that the goal is to eliminate foodborne illness outbreaks that
are just as costly or more for the food industry.
FSM: What are we currently seeing with regard to FSMA enforcement? Do you think
the FDA is capable of adequately enforcing the rules and providing validation guidelines
for new technologies?
DA: There is not very much enforcement so far, but there are 483s being written
around the lack of FSMA compliance. Of course, FDA is not capable of full enforcement for two reasons: lack of resources and lack of training of inspectors.
JR: Although the food side of FDA has recently received a limited increase in funding, FDA must rely on other agencies for enforcement assistance. It is doubtful that
FDA can adequately enforce the complex system of FSMA statutes.
FDA seems to struggle with the concept of validation and apparently has presented no solidly established preventive control foundation. The emphasis is still on
old-style HACCP concepts and a verification (inspection and audit)-based approach
that wallows in subjectivity. Newer environmental sampling tools capable of helping
supply chain members validate processes and procedures are required. The time lag
between taking the sample and obtaining the results must be drastically shortened if
supply chain members are expected to gain any semblance of preventive control.
DB: While FDA inspection activities abroad seem to have increased under FSMA,
we have seen no evidence where any recent FDA inspections emphasized food safe-
ty plans or were triggered by foreign supplier verification information. This could
mean that a) FDA is not yet strongly auditing against FSMA requirements, b) FDA-
audited plants are compliant with FSMA requirements, or c) inspected plants were
covered under other regulations such
as Seafood HACCP or LACF [low acid
canned food regulations].
WC: At this stage, some inspections are
being conducted by FDA and its state
partners. As communicated by FDA,
inspections during the early phase of
implementation are more educational in
nature, providing a learning ground for
industry to continue to improve while
also providing training opportunities
for the agency’s inspection force. This
approach fosters a spirit of cooperation
and partnership that marks a new posture from the agency that will certainly
serve both groups moving forward.
AS: In the region that I serve, we are
seeing some enforcement of FSMA
rules. Enforcement activities from the
state department of health, according
to inspected food industry personnel,
asked for HACCP plans instead of
FSMA food safety plans. As of May
2018, this confusion has been corrected
and the state department of health is accepting any food safety plan, regardless
of how it is labeled or what it is called.
With proper training on the FSMA
rules, FDA would be capable of adequate enforcement. Validation guidelines for new technologies may be more
reasonably addressed by units within
and external to FDA other than those
involved in enforcement, and in partnership with academia, private industry,
and others in the public sector.
TK: The current validation guidelines
are very broad by nature and hard to
find in the form of publications. From
my experience, FDA is committed to
work with industry and other partners
“FDA seems to struggle with the concept of
validation and apparently has presented no
solidly established preventive control
–John M. Ryan, Ph.D., PCQI