Preventive Controls requirements, meaning that small businesses have more time to
comply. Giving small companies less time wouldn’t improve the situation.
FSM: How do the other countries react to the U.S. FSMA regulations? Canada, Australia, and New Zealand try to meet them, but how about others?
DA: Others are accepting them if they want to do business with the U.S. Some
struggle quite a bit, and I think many don’t even understand what has to be done or
how to do it. There is not much help unless they pay for it.
JR: Many are attempting to duplicate or
adapt to the FSMA schemes. Others are
further ahead (e.g., EU). Rapidly evolving countries like China are struggling
with antiquated systems that leave them
playing catch-up. One might expect that
China will leapfrog FSMA since they have
a more authoritarian approach to enforcement.
DB: This includes awareness workshops in the local languages. In Thailand, the
National Bureau of Agricultural Commodities and Food Standards is working to
become a FSMA-accreditation body.
WC: Some countries have achieved comparability recognition from FDA, while a
few others attempt the process. Other countries like Mexico acknowledge the importance of FSMA compliance and pursue dual paths of educating their industry
on FSMA while pursuing the development of national standards that comply with
every other country in the world.
Ultimately, I think FDA’s commitment to partnering with regulatory authorities
in other countries is generally welcomed and is seen as an encouraging means to
collaboration, mutual understanding, and building reciprocal regulatory cooperation
tools that foster cooperation and better protect the supply chain.
AS: Some countries (e.g., Philippines, Indonesia, and Thailand) with food manufacturers exporting their products to the United States are generally aware of FSMA
and are taking FSMA courses to learn how to comply. There is confusion on the
different terminologies used and associated with FSMA. For example, some ask for
HARPC [Hazard Analysis and Risk-Based Preventive Controls] training or a PCQI
course. As trainers, we need to explain that what is important is to ensure that the
training session uses a curriculum that meets the FSMA training requirements.
TK: I am well aware about the focus on food security and FSMA in South America,
especially in Brazil. Brazil is also looking at Codex Alimentarius as the main international regulation for trade.
FSM: Has the Foreign Supplier Verification Program demonstrated the capacity to reduce the public health burden associated with imported food and food ingredients?
DA: Not yet, but it will in time.
JR: I haven’t seen any data on this one, but we love to point fingers, and it is easier
to point fingers at foreign suppliers than it is to clean up our own house.
DB: I think it’s too early to say. But experience (from Seafood HACCP) is that
FSMA regulatory action can be driven
largely by assessing the supplier verification programs kept on record in the offices of U.S. domestic importers.
WC: I think FSMA overall, and particularly FSVP, has positively impacted the
public health burden associated with
imported foods and ingredients; however, it is a bit early to determine its true
impact as we are still relatively early in
the implementation phase.
The outreach efforts to prepare industry for compliance raise the bar by
ensuring a common understanding of
FDA’s expectations and the risk-based
hazard approach required for imported
foods and ingredients. That alone is
noteworthy and encouraging.
AS: The FSVP has good intentions to
contribute to the protection of public
health from imported food and food
ingredients. Certain foreign suppliers,
however, consider FSVP requirements
so tedious that they are choosing not
to supply U.S. processors, leaving some
American processors vulnerable to
higher pricing or having no suppliers at
all. Some foreign suppliers also consider
their HACCP plan or third-party audit
results as proprietary information and
would not share them with their U.S.
buyers, who then resort to an audit of
the supplier as the only viable option
to demonstrate food safety. Operating
costs increase and FSVP increasingly
becomes a hardship to U.S. businesses.
TK: According to Food Safety News, the
total costs being imposed on importers
are $434.7 million on an annual basis.
“There remains a lack of understanding and
acceptance that the safety of the food they
produce precedes managing a food
–Aurora A. Saulo, Ph.D.