Is your business
FSMA ready?
If you’re involved in the food industry, you probably know
that changes are happening in the U.S. Food and Drug
Administration (FDA), particularly as the agency moves to
implement and enforce the Food Safety Modernization Act
(FSMA). If you haven’t felt the impact yet, you will. Make no
mistake: FSMA is going to place unprecedented scrutiny on
the functioning of the food industry.
The importance of compliance
“Fifteen percent of the U.S. food supply is imported,” said
Kathie Polychronis, manager of FDA compliance at Livingston.
“Along with this is a growing demographic of ‘at-risk’ people,”
Polychronis added, referring to a growing U.S. population that
includes more people who are older or younger, or who have
health issues such as allergies or food sensitivities, which make
them more susceptible to the dangers of food that is unsafe,
has not been properly inspected and/or does not meet the
standards set by the FDA.
The Government wants to ensure the health and safety of the
food supply by minimizing risk and stopping problems before
they happen. “The new laws are prevention-focused and the
U.S. government is working with other governments around
the world to try to standardize food safety,” said Polychronis.
Food importers and suppliers are going to feel the most
significant impact from FSMA. They will need to ensure they
Learn how the implementation of
the Food Safety Modernization Act will
impact your business.
are compliant with the regulations themselves, including
meeting new licensing requirements, and that both their
own facilities and their foreign suppliers’ facilities meet all
requirements. Importers will also need to adjust their budgets
to account for anticipated increases in user fees.
Understanding the FSMA
The first big step was completed at the beginning of the
year, at which point the FDA required that all food facilities
be registered. Foreign facilities had to be registered by the
beginning of April; in order to register, foreign facilities are
required to designate a U.S.-resident agent. Both foreign and
domestic facilities must renew their registrations every other
year. Failure to register means that shipments will be stopped
at the border.
“It applies to almost everyone,” said Polychronis. “If you
are a food manufacturer, food packer, warehouse facility or
distribution center, you have to be registered.”
Polychronis also outlined the other elements of FSMA that are
already in place. These include:
•Mandatory recall authority. The FDA has been given
the authority for mandatory recalls, as well as the ability
to suspend a facility’s registration. This means that if a
company refuses to voluntarily recall a product, the FDA
can force them to do so. The FDA can also suspend a
company’s registration, which will essentially shut down the
business, as a company without a registration is not allowed
to ship product or introduce food into commerce.
•A lower threshold for administrative retention. The FDA
can retain goods with only “a reason to believe” they are
non-compliant, as opposed to the previous regulation,
which required that the FDA have “credible evidence” that
the food or food product represented a threat to public
health. Administrative retention allows the FDA to detain
Get ready for FSMA:
food shipments for a limited period of time, during which
the agency undertakes legal action to formally seize the
product.
•Increased enforcement and scrutiny of food imports. The
FSMA ultimately aims to secure the food chain, including
the production and importation of food from foreign
facilities. As a result, in addition to increased inspection of
foreign food facilities, “FDA has stepped up enforcement
and is working closely with U.S. Customs and Border
Protection (CBP) to identify smuggled or misrepresented
food and food products,” explained Polychronis.
•New fees. New user fees are being imposed under law.
These include fees for the inspection of foreign facilities
and fees to re-inspect both domestic and foreign facilities
after violations are identified and corrections made. ”The
re-inspection fees can be significant,” added Polychronis.
• Ensure your registration is up-to-date.
• Assess your safety plans
• Establish and document preventive
measures
• Create a recall plan
• Plan for increased surveillance and
sampling at the border
Be proactive
The next big hurdle will be foreign supplier verification. While
not implemented yet, Polychronis said that this initiative
will require that food importers in the U.S. conduct supplier
verification exercises, or be held liable for issues and fees
arising from non-verified suppliers. Polychronis also says that
food importers can expect to see changes to the requirements
for import certificates for food deemed high risk. Finally,
Polychronis said that a fee-based voluntary qualified importer
program will be put in place. This will allow low risk food
importers with a solid compliance reputation to pay a fee that
will allow them to move to the head of the FDA review line.
Polychronis is advising clients to prepare themselves now for
the new regulations – both those that are already in place
and those yet to be implemented. She suggests that those
companies involved in the food industry take the following
actions:
1.Ensure your registration is up-to-date.
2.Assess your safety plans: you must have a written safety
plan in place that assesses hazards in your facility.
3.Establish and document preventive measures: under FSMA,
everything must be documented and traceable.
4.Create a recall plan and outline how each product
is manufactured and/or managed. Again, document
everything; good record keeping is a critical element of
FSMA.
5.Plan for increased surveillance and sampling at the border.
There are also some fairly straightforward, common sense
things companies can do to make sure they are compliant
and that you don’t have any nasty surprises. “For instance, if
you are using a supplier, make sure they are not on the U.S.
FDA Buyer Alert,” recommends Polychronis. And if you are
bringing shipments across the border, don’t cross at 2:00 a.m.
“Cross when the border is open and well-staffed,” added
Polychronis.
“Be proactive; monitor your shipments better and track
the guidelines as they’re published,” said Polychronis.
“Implementation doesn’t happen overnight; it’s a phased-in
process, so businesses have time to get ready.”
Contact your Livingston account executive e-mail us at solutions@livingstonintl.com or give us a call at 1-800-837-1063 Visit www.livingstonintl.com
2 Is your business FSMA ready?