The Food Safety Modernization Act (FSMA), signed into law on Jan. 4, 2011, expands the power of the Food and Drug Administration (FDA) to oversee food safety with a focus on prevention. Each year, about 48 million people get sick, 128,000 are hospitalized and 3,000 die—all from foodborne diseases that are preventable. The FSMA is designed to reduce those numbers by radically updating industry practices to ensure food safety and defense in an evolving global economy. Because of how vast and interconnected food supply has become, these regulations will impact a number of industries.

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Each year, about 48 million people get
sick, 128,000 are hospitalized and
3,000 people die—all from foodborne
diseases that are preventable.
Food Safety Modernization Act
The Food Safety Modernization Act (FSMA), signed into
law on Jan. 4, 2011, expands the power of the Food and
Drug Administration (FDA) to oversee food safety with a
focus on prevention. Each year, about 48 million people
get sick, 128,000 are hospitalized and 3,000 die—all from
foodborne diseases that are preventable.
The FSMA is designed to reduce those numbers by
radically updating industry practices to ensure food
safety and defense in an evolving global economy.
Because of how vast and interconnected food supply has
become, these regulations will impact a number of
industries.
FSMA Highlights
The FDA divides the elements of the FSMA into five key
areas:
1. Preventive Controls: Rather than simply
reacting to problems in the food supply, the
FSMA gives the FDA authority to institute
proactive measures to significantly minimize or
prevent problems before they occur.
2. Inspection and Compliance: Both inspection
and compliance are key tools for determining
risks and enforcing that proper safety measures
are taken. The FSMA allocates inspection and
compliance resources in a risk-based manner.
3. Imported Food Safety: In an increasingly
globalized marketplace with rising consumer
demand, food imports have risen drastically.
The FSMA makes sure that imported foods meet
U.S. safety standards.
4. Response: The FSMA gives the FDA mandatory
recall authority for the first time ever. While it
anticipates the FDA needing to use this
authority infrequently, it nonetheless offers the
agency this tool, as well as others, to ensure a
rapid response to serious problems.
5. Enhanced Partnerships: Prevention and rapid
response aren’t possible without close
partnerships with other agencies at all levels of
government. As such, the FSMA directs the FDA
to improve training of state, local, territorial and
tribal food safety officials.
Implementation Deadlines
In order to make the provisions more manageable and to
give all affected parties time to prepare, the FDA
staggered provisions over the course of several years.
Many of these have already been implemented, but
there are two important deadlines coming up.
1. The Sanitary Transportation of Human and Animal
Food Rule – March 31, 2016
The FSMA requires the FDA to institute transportation
practices that ensure food—both for humans and
animals—that is transported by motor vehicle or rail is

2. Food Safety Modernization Act
done under conditions that will not adulterate or
contaminate the food.
To serve that end, the Sanitary Transportation of Human
and Animal Food Rule, which goes into effect March 31,
2016, contains the following provisions:
• Vehicles: Any vehicle and transportation
equipment will have to be designed and
maintained in a way that ensures the food it
carries won’t become contaminated.
• Transportation Operations: Procedures and
practices employed during the transportation of
food—such as temperature controls and the
separation of food items from non-food items—
will need to ensure that it is not contaminated.
• Information Exchange: Shippers, carriers and
receivers will need to follow proper procedures
for the exchange of information about prior
cargo, the cleaning of transportation equipment
and temperature control.
• Training: Carriers will need to implement and
document training for all carrier personnel in
sanitary transportation practices.
• Records: Carriers and shippers will need to
maintain written procedures and records
related to equipment cleaning, prior cargo and
temperature control.
More information on sanitary transportation, including
guidance and regulatory documents, can be found
through the FDA’s website here.
2. The Intentional Adulteration Rule – May 31, 2016
The Intentional Adulteration Rule, which goes into effect
on May 31, 2016, seeks to defend the food supply from
the intentional introduction of biological, chemical and
radiological hazards. To achieve that end, the Intentional
Adulteration Rule requires facilities to take the following
measures:
• Conduct a self-assessment of vulnerabilities,
specifically those related to the following:
o Bulk liquid receiving and holding
o Liquid storage and handling
o Secondary ingredient handling
o Mixing and similar activities
• Identify actionable processes, which are points,
steps or procedures in a food process that will
require focused mitigation strategies
• Create and document a written food defense
plan, with specific mitigation strategies designed
to combat the identified actionable processes
The FDA has tools and resources related to food defense
available through its website, which can be found here.
Which Industries Are Affected?
Specifics on the FDA’s regulations and implementations
to FSMA can be found on the FDA’s website. Rely on
SterlingRisk for updates, as well as for other compliance
and risk management information.