1. MARK OLDHAM
Assistant Vice President
Senior Loss Control Consultant
303.414.6445
mark.oldham@lockton.com
Good Enough to Eat
Implementing the Food Safety Modernization Act
for Food Transporters
September 2016 • Lockton Companies
L O C K T O N C O M P A N I E S
The Food Safety Modernization Act has brought big changes to
companies in a variety of industries. Guidelines for transporters of
human and animal food from the Food and Drug Administration
(FDA) were released on April 6, 2016. The rules are focused on
core responsibilities to ensure food remains safe while in transit
and cover responsibilities of shippers, receivers, loaders, and
carriers involved in food transportation. This white paper provides
an overview of the newly published rules and suggestions to
ensure your company is in compliance.
WHO DO THE NEW RULES APPLY TO?
The new rules apply to transportation of foods other than those
transshipped through the United States, imported for future export, or
otherwise regulated by the United States Department of Agriculture
(USDA) for inspection of meat, poultry, and egg products.
4 Steps to Implement the
Food Safety Modernization Act
March 2016 • Lockton®
Companies
L O C K T O N C O M P A N I E S
JON FINN
Loss Control Consultant
404.460.0749
jfinn@lockton.com
The Food Safety Modernization Act (FSMA) was signed into
law on January 4, 2011, marking the most significant change
to US food safety laws since 1938 (National Sustainable
Agriculture Coalition).
FSMA increased the authority of the Food and Drug Administration
(FDA) in an effort to prevent foodborne illnesses. Since the law
was passed, rules for administering the requirements have been in
development, with the final set of rules published in the Federal
Register September 17, 2015.
Who does FSMA apply to?
FSMA is primarily focused on food producers, manufacturers, and
suppliers. Restaurants are not required to register with the FDA unless
they are providing to interstate conveyances, such as airlines, central
kitchens, or other facilities that do not prepare and serve food directly
to consumers (US Government Publishing Office, 21 CFR § 1.227).
Therefore, restaurants and retailers are exempt from the provisions of
covered facilities, but could be covered by parts of the new law, such as
the foreign supplier verification program, which applies to importers.
The Centers for Disease Control and Prevention
(CDC) estimates that foodborne illnesses cause
(Centers for Disease Control and Prevention, 2015)
48 MILLIONAmericans to be sick
128,000
to be hospitalized
and claims
3,000lives annually
An overview of the Food
Safety Modernization
Act (FSMA) is covered
in a previous Lockton
White Paper.
2. 2
The Food and Drug Administration continues to
publish foundational rules for the Food Safety
Modernization Act of 2011. The FSMA will
eventually have rules pertaining to all seven key
elements of the Act:
1. Current good manufacturing practice and
hazard control analysis and risk-based
preventive control for human food.
2. Standards for the growing, harvesting,
packing, and holding of produce for human
consumption.
3. Current good manufacturing practice and
hazard analysis and risk-based preventive
controls for food for animals.
4. Foreign supplier verification programs
(FSVP) for importers of food for humans
and animals.
5. Accreditation of third-party auditors/
certification bodies to conduct food safety
audits and to issue certifications.
6. Focused mitigation strategies to protect
against intentional adulteration.
7. Sanitary transportation of human and
animal food.
The Rule Does Not Apply to:
™™ Shippers, receivers, or carriers with less than $500,000 annual revenue.
™™ Farms.
™™ Food shipments through the United States, or imported for future export,
where none will enter into the United States’ food stream.
™™ Transportation of food-quality gasses or food contact substances (food
packaging materials and additives otherwise regulated by the FDA).
™™ Human food by-products for animal food not requiring further processing.
™™ Food within a container that does not require temperature control for
safety (TCS).
™™ Transportation of livestock for food, excepting molluscan shellfish.
Waivers Will Be Made in the Future For:
™™ Transportation of milk products inspected under the National Conference
on Interstate Milk Shipments.
™™ Establishments permitted and inspected under Retail Food Programs—
such as restaurants, supermarkets, and home grocery delivery operations.
WHEN DO COMPANIES NEED TO BE IN
COMPLIANCE?
Most companies are required to be in compliance by April 2017. Small
businesses other than motor carriers who are not also shippers and/or receivers
with less than 500 employees, or motor carriers having less than $27.5M annual
receipts, have until April 2018 to comply.
Transportation Equipment Must Be:
™™ Designed and maintained to prevent transported food from becoming
contaminated.
™™ Maintained in a sanitary condition.
™™ Adequately designed, maintained, and equipped if required by the food
being transported to maintain temperature (TCS).
™™ Stored in a manner to prevent pests or other contaminants.
3. September 2016 • Lockton Companies
3
REQUIREMENTS
1. Applies to shippers, receivers, loaders, and carriers.
2. Responsibilities can be assigned by a written
agreement.
3. Responsibilities must be assigned to a competent
supervisory person.
4. All transportation operations must prevent food
from becoming unsafe.
5. Potential for cross-contamination controlled between
goods being transported in the same load.
6. Bulk and not-enclosed foods protected from
contamination and cross-contact.
7. Effective controls if the food is temperature safety-
sensitive.
The type of food (human, animal, and pet) and
production stage (raw material, ingredient, and finished
product) must be considered in determining the needed
conditions and controls during transportation.
The roles of shipper, receiver, loader, and carrier
conducted under one entity can operate under common
integrated written procedures to ensure sanitary
transportation of food if consistent with the following
responsibilities.
All involved functions—shipper, receiver, loader, and
carrier—must take action to remove the food from
distribution if they become aware of any conditions that
could make the food unsafe.
All involved functions—shipper, receiver,
loader, and carrier—must take action to
remove the food from distribution if they
become aware of any conditions that could
make the food unsafe.
4. 4
SHIPPER RESPONSIBILITIES
™™ Must specify in writing to the carrier all necessary
sanitary specifications and cleaning procedures to
prevent the food from becoming unsafe during
transportation.
™™ Must specify in writing to the carrier any
requirements for temperature of the food being
transported.
LOADER RESPONSIBILITIES
™™ For food not completely enclosed in a container
(partially open to the surrounding environment—
open wooden basket or crate, open cardboard box,
vented cardboard box with a top, or vented plastic
bag, but not in bulk), inspect the vehicle to ensure it
is in appropriate sanitary condition.
™™ This inspection includes the vehicle’s physical
condition, free of evidence of pest infestation or a
previous cargo that could cause the food to become
unsafe during transportation.
™™ For foods subject to temperature control in shipment,
the transportation container is precooled and sanitary.
RECEIVER RESPONSIBILITIES
™™ For food subject to TCS, assess the food for evidence
of temperature variances/abuse during shipment.
™™ This assessment includes measuring temperature
of the food, temperature of the container, and
sensory inspection (off-odors and visual indications
of temperature abuse from the containers and
container).
5. September 2016 • Lockton Companies
5
CARRIER RESPONSIBILITIES
When the shipper and carrier have a written agreement
that the carrier is responsible for sanitary conditions
during shipment, the carrier can be held responsible for
the following, as applicable to the written agreement:
™™ Transportation equipment meets the shipper’s
specifications and is appropriate to maintain the
food in a safe condition during transport.
™™ If requested by the shipper at completion of the
shipment:
hh Provide the operating temperature specified by
the shipper.
hh Demonstrate the temperature was maintained
during shipment By an appropriate means
agreeable to the carrier and shipper, such
as load/unload temperature measurements,
or time/temperature data taken during the
shipment.
™™ Precool the container if the food is TCS.
™™ Bulk vehicle previous cargo and most recent
cleaning information.
™™ The carrier must have written procedures for
cleaning, sanitizing, and inspecting containers for
food safety, temperature control, and bulk container
previous cargo and cleaning.
TRAINING
™™ Carriers, where required under a written contract
for food safety in transit, must train engaged
personnel in:
hh Food safety awareness.
hh Basic sanitary transportation practices.
hh The carrier’s responsibilities.
—— Upon hire and as needed thereafter.
™™ Establish and maintain records of the training.
6. 6
RECORDS
Shippers are required to demonstrate they have:
™™ Provided specifications and operating temperatures
to the carrier.
™™ Written agreements for transportation equipment
sanitation, previous cargo, and temperature control.
Records must be maintained for 12 months beyond
termination of the agreements.
Carriers are required to retain records of written
procedures for cleaning, sanitizing, and inspecting
containers for food safety, temperature control, and bulk
container previous cargo and cleaning. Records must be
maintained for 12 months beyond their use.
Carriers are required to retain records of training of
engaged personnel for 12 months beyond when those
persons stop performing those duties.
Carrier, shippers, loaders, and receivers must maintain
records of any written agreements associated with the
requirements of the FSMA for 12 months beyond
termination of those agreements.
Carriers, shippers, loaders, and receivers operating under
a single legal entity with common integrated written
procedures for sanitary transportation of food maintain
records of those written procedures for 12 months
beyond when those procedures are in use.
Records Must Be:
™™ Available to the authorized person immediately upon
oral or written request.
™™ Original, true copies or electronic copies.
™™ Electronic records are permitted if they can be
produced at the location within 24 hours, except
for carrier written procedures for cleaning,
sanitizing, and inspecting containers for food safety,
temperature control, and bulk container previous
cargo and cleaning, which must be maintained on site
as long as the procedures are in place.
WAIVERS
The FDA will waive requirements under the FSMA when
it is determined through petition the waiver will not result
in unsafe food transportation or be contrary to the public
interest. The process for requesting a waiver is provided
in the final rule, Section 1.914.
7. September 2016 • Lockton Companies
7
The Food and Drug Administration Food Safety Modernization Act (FSMA) expands regulations
for food safety beyond the Hazard Analysis and Critical Control Point program of the US
Department of Agriculture and expands on risk-based controls. Companies involved in the
manufacture and transportation of food can receive updates and notification from the FDA at
http://www.fda.gov/fsma.
RECOMMENDATIONS TO COMPLY WITH THE FSMA
TRANSPORTATION OF HUMAN AND ANIMAL FOOD
1. Any company engaged in transportation of food should have a clear policy empowering all employees to elevate
any concerns over the condition of food being received or shipped that presents any possibility of an unsafe food
condition. It is likely existing Good Manufacturing Practices (GMP) training includes this requirement.
2. Any company engaged in food transportation should maintain all records associated with food safety in transit at
least 12 months after the transit is complete.
3. A company acting as a shipper, carrier, loader, and receiver (an owned transportation operation), should develop
policies, procedures, and training to ensure food in transit is not subject to becoming unsafe while in transit. There
should be one policy to cover all transportation operations.
4. Food manufacturers that do not act as a carrier should develop standardized policies and procedures executed
by their carrier for food safety, with emphasis on the sanitary condition of vehicles, prior cargoes, cleaning, and
temperature control.
5. Food manufacturers who load carriers’ trailers, an industrywide practice, should:
A. Develop a Preload Checklist for inspection of transportation equipment, including temperature readings
recorded of the product and equipment if the food is to be shipped under refrigeration.
B. Train loaders in food safety, food safety in transportation, and inspection of transportation equipment. It is
probable that basic food safety GMP may not suffice.
6. Food manufacturers who receive food products should:
A. Develop a Preunload Checklist for inspection of the products for condition and evidence of contamination.
B. If a product is received under refrigeration, the checklist should include recorded temperature measurements.
Noncontact infrared thermometers could be very useful.
