FSMA: New Food Safety Rules Mandate Prevention and Risk
Assessment by Food Operators (continued from page 33)
with HACCP (hazard critical control points and prevention)
standards, which include hygiene training for all employees,
environmental monitoring programs to verify the effectiveness of pathogen controls, food allergen control programs, a
recall plan, and supplier verification activities related to their
adherence to food safety standards.
mandated recalls. Importers can participate – for a fee –
in a voluntary qualified importer program, a type of fast
track that promises fewer inspections, detentions or recalls.
The FDA also has the power to require import certifications
for certain high-risk food, determined by the risk of the
manufacturer, the country of origin or the commodity itself.
Until the end of 2010, the FDA had only limited enforcement
powers to stop operators from shipping contaminated food
or order recalls. The agency could only act when sufficient
evidence of outbreaks had been gathered to urge producers
to voluntarily shut down operations and recall products. The
FSMA changes the paradigm. The FDA can now demand
administrative detentions of shipments if there is “reason to
believe that an article of food is adulterated or misbranded,”
and order recalls or even suspend registrations based on
well-founded suspicions of food contaminations with adverse
effects on human and animal health.
Contaminated fruits and vegetables have often been the
cause of severe outbreaks of food-borne illnesses (the latest
major case happening in Germany with bean sprouts) and
one portion of the FSMA deals with new scientific standards
for reducing safety risks of produce. The FSMA obligates
the FDA to “provide for minimum science-based standards”
to reduce safety risks of all fruits and vegetables, including
“biological, chemical, and physical hazards, those that occur
naturally, may be unintentionally introduced, or may be intentionally introduced, including by acts of terrorism.” These
new rules may affect hundreds of thousands small and very
small operators, and may be difficult to enforce.
It is already evident that the number of inspections mandated
by the law of both domestic and foreign facilities to ensure
compliance with the law cannot be implemented without a
major increase in the FDA’s budget. However, some members
of the U.S. Congress not only refuse to grant the FDA more
funds, but seek to significantly reduce the agency’s current
budget. The FDA currently looks for ways to adapt the manner
and frequency of inspections to realistic budget levels and
cooperate with public and private organizations that conduct
audits based on existing safety standards, such as IFS (
International Food Standard, worldwide the leading standard),
SQF (Safe Quality Food, originated in Australia and adopted in
the United States), BRC (British Retail Consortium Standard)
and FSSC 22000 (Food Safety Standard Certification, replaces
the Dutch HACCP).
Over the next two years, the industry should expect a great
number of new food safety rules that may significantly affect
the operating procedures of some businesses.
Importers of foreign foods also will face a major paradigm
shift. Food and beverages from abroad contribute about 15
percent of the overall food supply. Importers now must verify
that foreign suppliers operate under the same preventative
safety methods as domestic firms and are legally responsible
to pay the administrative costs of product detentions and
Arnim von Friedeburg is managing partner of German Foods North America, an independent agency
located in Washington, D.C., working with suppliers,
retailers, associations and governmental agencies
in North America, Germany and German-speaking
countries to facilitate trade of food, beverages and
agricultural products between the two regions.