FSM: What impact is implementation having on industry thus far? Which parts of
FSMA implementation is the food industry struggling with the most?
DA: Struggles include how to employ an environmental management plan and
manage zone 1 testing (which is not required). Supply chain control is also proving
a struggle as is what to tell customers and what to demand of customers if the customer is controlling the risks.
JR: Food carriers, to some extent, have
been left out of food safety drives, while
farms, packers, processors, etc. have had
several years to upgrade their food safety
systems. This lag in experience with food
safety requirements has left some carriers
completely confused to the point that they
are doing what receivers define and require
to the exclusion of FSMA rules.
DB: The primary impact on local industry to date seems to be time spent in awareness and Preventive Controls-Qualified Individual (PCQI) training.
WC: FSMA has spurred a frenzy of activity within the regulated industry to get into
compliance. I find many firms are still in the process of trying to update their existing programs to meet the FSMA requirements. I’ve observed many struggling with
validation of their preventive controls, conversion of their existing HACCP plans to
risk-based preventive controls plans and their current procurement practices into a
compliant FSVP, or just determining whether they are subject to FSVP.
FSMA has had a positive impact also. There has been a tremendous infusion of
attention and resources allocated to training to meet the PCQI requirements that
state an individual must have the education, experience, or combination thereof
necessary to perform the tasks assigned for product safety. This is driven also by the
updated Current GMPs [Good Manufacturing Practices] that communicate FDA’s
training expectations. I have also observed increased attention to areas that previously lacked adequate support or oversight, such as sanitary transport and sanitation.
AS: Some of the FSMA elements that the food industry is struggling with include
laboratory analyses due to a limited number of available labs, identifying and organizing their programs (and the voluminous amount of data) in preparation for
the development of FSMA food safety plans, and getting overwhelmed by the large
number of “things to do” in order to pass future audits and inspections. As a result,
many small food industry establishments look to consultants to develop their FSMA
food safety plans so that they can remain available to manage the business. There
remains a lack of understanding and acceptance that the safety of the food they
produce precedes managing a food business. If the food they prepare is not safe, it is
not a food. If there is no safe food, there is no food to sell.
TK: I hear the industry struggles with FSMA transportation rules and their interpretation and implementation.
FSM: What is FDA’s stance on compliance via GFSI (Global Food Safety Initiative)
schemes at this stage of implementation? Is there sufficient training available for companies exporting to the U.S. to meet FSMA requirements?
DA: FDA seems to accept that meeting GFSI requirements puts a plant in a good
place regarding FSMA Preventive Con-
trols compliance. But having a GFSI
certification does not yet reduce the
likelihood of an FDA inspection. In
my view, the GFSI standards are very
similar to FSMA; where GFSI struggles
is auditor competency, and thus FDA
does not have as much confidence as
they could on a GFSI audit. There is
very little training available for foreign
firms, and that is not likely to change
due to resources.
JR: FDA seems to be somewhat incapable of competing with other compliance
approaches. They do not seem to be
getting the business-level and industry-wide buy-in that groups such as GFSI
DB: National regulatory agencies and
local trade associations have made efforts to ensure FSMA awareness on a
local basis. Most major exporters in Asia
have certifications under a GFSI program; therefore, they are mostly compliant with food safety plan requirements.
WC: FDA has contemplated use of
third-party audits, such as those benchmarked by GFSI, as part of its overall
compliance strategy, particularly to
foster compliance with the Produce
Safety rule; however, they have clearly
communicated that compliance to such
standards does not ensure full FSMA
compliance. The agency has stated in
many forums its intention to work with
the produce industry and other partners
to improve the rigor and reliability of
private audits. To this end, FDA has
held several public meetings and a 2-day
public hearing on the role of strategic
partnerships for improving the safety of
imported food where questions about
“FSMA brings enhanced risk-based HACCP
principles to all foods for a preventive, rather
than reactive, approach to food safety,”
–Dan Brooks, PCQI