Food Safety Magazine (FSM): Describe what you feel are the strengths and weaknesses
of the FSMA regulations.
David Acheson: The biggest strength of FSMA is that it has taken us into a comprehensive world of risk-based controls with a heavy focus on prevention. The inclusion
of supply chain control and environmental control requirements for RTE [ready-to-eat] foods is a necessary focus in today’s food safety environment. The greatest
weakness is that there are some key parts waiting for regulations, such as high-risk
foods and the move toward greater requirements for product tracking. The recent romaine outbreak is a good example of that need. Obviously, the lack of resources for
both education and inspections continues to be a weakness. I personally don’t like
the fact that very small entities are not covered by FSMA; I would much rather they
be covered but with more time and education to allow them to get it right. Similarly,
the fact that juice and seafood are exempt
adds more complexity where a one-size-fits-all approach would have been better.
John Ryan: FSMA regulations attempt to
define a complex system-wide set of rules
designed to move the food supply chain
to improve over the next 50 years. Such
changes generally take at least a generation to effectively implement. Current deadlines for “full implementation” are unrealistic.
With little or no ability to rapidly and cost-effectively detect primary hazards at
the farm level, contaminants are set to travel through the supply chain with no traceability clearly defined or required. This leaves the public exposed and recall efforts
lacking. Greater emphasis must be placed on low-cost, easy-to-implement hazard-detection tools (sampling) that can be put in the hands of farmers for early hazard
detection. Traceability must be mandated, and food movement, identity, condition,
and location information should be visible as real-time information.
When FDA teams get involved in recall investigations, they ignore “food safety”
certificates and head straight for areas where they can take samples for laboratory
analysis. These samples provide objective evidence. Food safety audits provide
subjective information about food safety. If FDA leans solidly on objective sample
data, so should the entire food chain. The industry is being misguided by old-timers
in food safety and audit companies that do not shift to dependence on sampling in
order to establish preventive control validity.
Dan Brooks: After years of Seafood and Juice HACCP [Hazard Analysis and Critical Control Points] regulations, FSMA brings enhanced risk-based HACCP principles to all foods for a preventive, rather than reactive, approach to food safety.
FSMA aligns U.S. food safety to global standards with the convenience of familiar
certification protocols. On the downside, the FSMA regulation set seems complex,
with complex implementation and exemption schedules.
Willette Crawford: Regarding FSMA’s weaknesses, I believe there are some unin-
tended consequences and missed opportunities. Specifically, a more comprehensive,
yet flexible, risk-based approach could have been employed for agricultural water in
the Produce Safety rule. Additionally, I believe the size exemptions in the FSMA law
developed by Congress miss the mark of prevention and shared responsibility across
the supply chain. Additionally, the question of sufficient, skilled inspection resourc-
es to support implementation and enforcement is a weak point in the system. All
things considered, there is always the opportunity to update regulations and adjust
as scientific information evolves.
I believe some of FSMA’s strengths
are as follows: FSMA articulates food
safety objectives that were once vague
in the implementing regulations and
further clarifies the agency’s expectations through compliance guidance
documents and training programs and
tools. For example, produce growers
are no longer left to their own devices
to figure out what hazards are of main
concern and what operational considerations need to be made when selecting
appropriate control strategies. They now
have FDA’s expectations and concerns
communicated through guidance and
the Produce Safety rule. Similarly, carriers in the transport industry and importers have now had their roles in the food
safety equation explained for them.
FDA clarifies the shared responsibility throughout the supply chain through
the seven finalized regulations that expand FDA’s jurisdiction to segments of
the industry previously out of its reach.
Such is the case for retailers that may
now fall under FDA’s purview for the
Foreign Supplier Verification Program
(FSVP) regulation. This shared accountability will help fill some of the gaps in
our disjointed supply chain that were
previously out of reach.
The flexible, goal-oriented approach
of the FSMA regulations allows industry
to implement creative, cost-effective
controls appropriate to their scale and
circumstances rather than follow one-size-fits-all requirements that may be
inappropriate or out of reach.
Aurora Saulo: FSMA regulations are
being implemented at an opportune
time when the public is more aware
of fitness and health issues, and of the
“The biggest strength of FSMA is that it has
taken us into a comprehensive world of risk-
based controls with a heavy focus on
–David W. K. Acheson, M.D., F.R.C.P.