Terry Levee
AERS Manager
Deloitte and Touche LLP
Key Elements
Segregation of Foods and Non-Foods
 Temperature Monitoring
 Distinction Between Packaged Foods v. Bulk
Commodities
 Trailer/Truck Washing Requirements
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History
 During the late 1980s, complaints and press
reports indicated trucks were hauling garbage
and subsequently used to carry meat, poultry and
produce without a sanitation step in between.
 GAO looked into the matter and upon review
concluded it could not find any conclusive
evidence that this was a common practice.
 Although the report stated these findings,
Congress enacted the Sanitary Food
Transportation Act in 1990.
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History
This Act directed DOT to address regulations
regarding the transportation used to transport
nonfood products that could make food unsafe.
In 1993 DOT issued a proposed rule.
In 1998, DOT’s OIG determined the agency did not
have the expertise to implement the law while FDA
did.
In 2005 Congress amended the law and directed FDA
to implement it, but without a deadline. FDA takes
initial steps in 2010 to develop the regulation.
Although FDA has not issued a rule, FSMA-Section
111 Sanitary Transportation of foods will now cover
it.
Over the last 35 years FDA has only cited a
handful of events that was used to justify the
need for the regulation.
 None of these incidents involve the
transportation of food by the major distributors,
restaurants or supermarkets but by smaller local
independent distributors.
 The report from the 2007 Interstate Food
Transportation Assessment Project that notes
there were “little or no areas of concern” with
large semi-trucks—the mode of transportation
used by major distributors, restaurants and
supermarkets.
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The state of current laws, regulations and guidance
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Why new rules?-The incidents of record used to justify the
rule are violations of current laws, regulations and misuse of
guidance documents
 Chapter 3-FDA Food Code, 21 CFR and GMP’s
 2007 Food Producers, Processors, and Transporters: Food Security
Preventive Measures Guidance
 2006 Notice from FDA to Growers, Food Manufacturers, Food
Warehouse Managers, and Transporters of Food Products on
Decontamination of Transport Vehicles
 2008 Guidance for Industry: Guide to Minimize Microbial Food
Safety Hazards of Fresh-cut Fruits and Vegetables
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DOT has stated that “taken together, the . . . FDA regulations
and implementing guidance documents adequately address
the overarching goal of protecting food and food products
from contamination during transportation.”
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So how much food is really shipped?- based
on an industry average of a major retail
grocer
◦ A distribution center facility ships in excess of 2.9
million cases of product every week.
◦ That’s more than 150 million cases of food that is
shipped out of this distribution center annually.
◦ To keep this amount of food safe during
transportation, one key is to have a sound logistics
program.
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In retail, restaurant and end use product
distribution, the risk of microbial contamination
from the trailer may be minimized by following
leading practices that reduce contamination since
products are contained in packaging and are not
in direct contact with the trailer.
Different concerns exist with bulk transportation
as most all product is raw and in direct contact
with the trailer increasing the risk of
contamination.
The risk of cross contamination of packaged food
and nonfood products may be minimized by
current industry best practices.
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It’s a common industry practice to have quality
control processes in place to check and inspect
the temperature of products during shipping,
unloading and loading activities.
One such common practice is that companies
check temperatures of fresh, temperaturesensitive products when making backhaul pickups and receiving product.
Other common practices is for receiving firms to
implement policies to have 3rd party distributors
record product temperatures en route to their
distribution center.
◦ Trailers are frequently swept throughout the day to
remove any debris.
◦ Spills and odors are addressed promptly and
thoroughly when identified through inspection.
◦ Inspection, verification and documentation are
integral part of most food safety plans.
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Retailers, wholesalers and distributors
should have effective methods which meet
the needs of their individual supply chain
systems.
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Most non-bulk foods being transported by
the industry are enclosed in packaging and
do not come into direct contact with trailer
surfaces.
When following the above leading practices trailer washing regimens may not be
appropriate or necessary.
A review of your trailer cleaning program may
be needed to determine if your current
program meets the act.
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Current industry practices indicate foods may be
transported simultaneously and sequentially with
nonfood products with minimal risk.
By using a leading practice that segregates food
and non foods on the same trailer the potential
risk of cross-contamination from nonfood may
be minimized.
By implementing a leading practice it may
minimize excessive wear and tear on trucks,
reduce man-hours and reduce gas emissions and
consumption for fuel.
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Employee awareness and training
Management review of records (sanitation, temperature,
shipping manifests)
Proper communication between shipper, transporter and
receiver
Applicable loading procedures for transportation units
Applicable unloading procedures for transportation units
Suitable documentation accompanying each load (tanker
cleaning record, seal numbers on the bill-of-lading,
temperature readings, time in-transit and time on docks
Appropriate packaging/packing of food products and
transportation units
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Sanitation
Temperature Control
Proper Placement (Co-mingling of loads)
Pest Control
Handling
Complete security management (seals)
Receiving
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Involve stakeholders
Focus on internal core competencies
Gain access to knowledge and technology
Promote real-time organizational awareness
of opportunities for innovation
Lessen the cycle time for experiment
conception and design
Tap into the power of grassroots participation
to drive acceptance, adoption and expansion
of ideas
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First and foremost FDA must take a science
and risk-based approach in implementing
SFTA
Reassess your current programs, identify
gaps and implement new programs in the
most efficient manor to help minimize costs.
FDA should implement SFTA allowing the
distribution industry the flexibility to develop
and maintain current industry best practices.
Terry Levee
AERS Manager
Deloitte and Touche LLP
703-251-1068
tlevee@deloitte.com