at markets and farm stands are exempt.
This proposed exemption was the topic
of hot debate, but was included in the
The Implications of the FSMA
By Ian Harrison
As a result of the FSMA that was signed into law by President Obama on January 4, 2011, any company that manufactures, processes, packs, distributes, receives,
holds or imports food into the U.S. will face greater scrutiny and tougher penalties if it
fails to comply with the new safety protocols.
Impact Will Be Rapid and Significant
The FSMA is designed to revamp food production safety standards and renew consumer confidence in the safety of the food supply. It comes in the wake of a number
of recent, high-profile food contamination events that affected thousands of people
across the country and tragically resulted in a number of deaths.
The new legislation requires manufacturers and farmers to implement comprehensive anti-contamination procedures and then monitor and test their effectiveness going
forward. Food manufacturers will have to demonstrate how they have amended their
processes to comply with the new legislation, to thoroughly document all processes
and procedures and hold these records ready for inspection. Previously, the law relied
on government inspectors being in the right place at the right time to identify
In addition, rather than manufacturers voluntarily reporting problems, under the
FSMA, the FDA has the authority to require manufacturers to recall food products—
even if contamination is only suspected but not proven. The FSMA also requires the
FDA to regularly inspect farms and food processing plants and visit ‘high-risk’ facilities. These new inspections are likely to include manufacturers of ingredients—such as
milk products or peanuts—that are widely used in the food supply chain and can be
the cause of concern in multiple products. In the past, such FDA visits tended to be
infrequent, and farms were rarely inspected.
The FSMA does not stop with U.S. producers, but also applies to foreign food
companies. To help prevent contaminated food entering the food chain, the FSMA requires importers of food and beverage goods to verify that the products have been
produced and processed in a way that meets U.S. safety standards. Whereas previously,
the FDA only inspected around 1% of imported food products, this percentage is
likely to increase substantially now that the FSMA has been signed into law.
The FSMA applies to all whole and processed foods and beverages except meat,
poultry and some egg products, which are regulated under separate laws by the USDA.
However, under an amendment brought by Sen. Jon Tester (D-MT), small farmers
with revenue of less than $500,000 per year and those who sell directly to consumers
Preparing for the FSMA
Food producers who already have
strong procedures and controls in place
should not find the new requirements
too onerous. However, they will now
have to audit their production processes,
highlight any weaknesses or areas for improvement and confirm that they are operating to best practice levels.
Producers not currently operating to
such high standards may well find the
enhanced scrutiny from the FDA something of a wake-up call. In particular,
manufacturers that source ingredients
from overseas from regions where food
hygiene and processing standards may
not be as stringent as those in the U.S.
or that rely on a web of subcontractors
not all of whom follow the required procedures or maintain appropriate standards will be particularly at risk. The
FSMA requires producers around the
world to verify that products grown and
processed overseas meet the new safety
standards or face their products being
denied entry into the U.S.
It is unlikely that any reputable business would knowingly purchase substandard ingredients and put people’s lives
and their reputation at risk, but the
FSMA will focus the minds of food
manufacturers and importers and will
force companies to review their sourcing
criteria and due diligence procedures.
Early Test Cases Likely
It is likely that FDA will seek to bring
a number of early cases to put its new
powers to the test and to demonstrate
how the legislation will work in practice.
Domestic producers will be at particular
risk of prosecution, as will importers,
mostly from neighboring countries in
Food companies could be placed in a
difficult position if forced into making a
precautionary recall without specific evidence of actual contamination. Whereas
in the past they would have been able to
negotiate with the FDA, under the new
terms of the FSMA, food companies can
no longer rely on their own decision-