Sanitary Transportation of Human and Animal Food - Maritime Law Association of the United States
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Sanitary Transportation of
Human and Animal Food
Maritime Law Association
of the United States
May 5, 2021
Patrick Brecht, PhD
PEB Commodities, Inc.
P E B
About the Speaker
Dr. Patrick E. Brecht is a leading authority in the handling of perishable
products and has directed four multinational refrigerated cargo
businesses. He was also a Cornell University professor. He has offered
forensics expertise and expert opinions involving millions of dollars of
perishable cargo disputes. He also pioneered and introduced the first
computerized marine refrigerated containers. Dr. Brecht has been actively
involved with food safety and sanitary transportation of food for decades.
Dr. Brecht jointly authored Refrigerated Transportation Best Practices
Guide, Summary & User Guide: FDA’s Sanitary Transportation of Food
Final Rule Advancing the Sanitary Transportation of Human and Animal
Food, International Refrigerated Transportation Association, Sanitary
Transportation of Food Compliance Matrix. Special Commodities, Marine
Container Transport of Chilled Perishable Produce, Refrigerated Trailer
Transport of Perishable Products and Air Transport of Perishable
Products and chapters in books.
Dr. Brecht is a scientific advisory counsel member for the Global Cold
Chain Alliance (“GCCA”) and President of PEB Commodities, Inc.
©2021 PEB Commodities, Inc.
Agenda
• Introduction
• Food Safety Modernization Act
• Sanitary Food Transportation Act
Preventive Controls, Insights into
transportation
• Review of rules & guidance
• Case Studies/Current Issues
©2021 PEB Commodities, Inc.
Why are we here?
John F Kennedy:
“The time to repair the roof is when the sun is shining.”
Source:: Doug Busch ©2021 PEB Commodities, Inc.
FDA Food Safety Modernization Act
Annually Foodborne incidents
• 48 million people (1 in 6 Americans)
get sick
• 128,000 are hospitalized • The FDA Food Safety Modernization
• 3,000 die Act (“FSMA”), was signed into law
by President Obama on January 4,
2011.
• The law moves FDA from a
regulatory agency to a new law
enforcement authority designed to
achieve higher rates of compliance
with prevention and risk-based food
safety standards.
The major mandates of the Act are:
1. 2 3 4 5 6
Registration Hazard Analysis Verification Inspection & Record Keeping Penalties
& Preventive Frequency Requirements
Controls
©2021 PEB Commodities, Inc.
Sanitary Transportation of Food Rule
• Sanitary transportation rule was
established in the 2005 legislative
process but not implemented.
• The rule was finally adopted and
included in the 2011 FSMA’s Sanitary
Transportation of Food Rule. The rule
is now final & published (April 6,
2016). Compliance dates are 1 year
after the date of publication of the final
rule for most businesses and 2 years
for small businesses.
• Significantly expands the powers of
the Food and Drug Administration
(FDA) with respect to food
distribution. The FDA moves from a
reactive governmental body once a
problem was identified within the Cold
Chain to a pro-active law enforcement
agency with new tools at their
disposal.
©2021 PEB Commodities, Inc.
DOJ and FDA Say Criminal
Prosecution of Food Companies is
a Priority
The Department of Justice (DOJ) has formally announced that it has
partnered with FDA and has adopted a policy of initiating criminal
investigations against any company (or its employees) that sells a
product that cause human illness. In fact, in prepared remarks by former
Principal Deputy Assistant Attorney, Benjamin C. Mizer indicated that
FDA and DOJ view any human illness caused by a food product as a
potential violation of the law.
“If you sell adulterated food - or have some role in handling, distributing,
or maybe even transporting anywhere along the food chain of that
adulterated food, you would be liable to some extent - regardless of the
cause or origination of the contamination.” Dr. David W. K. Acheson.
©2021 PEB Commodities, Inc.
Food Safety: States are getting into act
Sec. 1. As used in this chapter, "acceptable temperature"
means a temperature established in a rule or regulation
adopted by the state department of health with respect to the
storage and transportation of a particular food and enforced by
the state department of health or a local health department.
Sec. 7. (a) A law enforcement officer may inspect a motor vehicle used to
transport food to determine compliance with section 6 of this chapter
(b) This subsection applies if, during the course of an inspection under
subsection (a), a law enforcement officer determines that:
(1) the temperature of the food is more than two (2) degrees above the
acceptable temperature;
(2) the food exhibits outward signs of contamination, spoilage,
deterioration, putrefaction, or infestation; or
(3) the food is improperly loaded in a manner that increases the risk of
cross-contamination.
A person who operates a motor vehicle described in this subsection commits
a Class A infraction.
Ref: 2013 Indiana Code TITLE 8. UTILITIES AND TRANSPORTATION ARTICLE 2.1. MOTOR CARRIER REGULATION CHAPTER 27.
TRANSPORTATION OF FOOD ©2021 PEB Commodities, Inc.
Who is Covered?
The STF rule applies to:
• Shippers, receivers, loaders and
carriers who transport food in the
United States by motor or rail vehicle,
whether or not the food is offered for
or enters interstate commerce.
• Shippers, in other countries who ship
food to the United States directly by
motor or rail vehicle (from Canada or
Mexico), or by ship or air, and arrange
for the transfer of the intact container
onto a motor or rail vehicle for
transportation.
©2021 PEB Commodities, Inc.
Who is Covered?
(Con’t)
• Companies involved in transportation
of food intended for export are
covered by the rule until the shipment
reaches a port or U.S. border.
• The rule does not apply to exporters
who ship food through the United
States (such as from Canada to
Mexico) by motor or rail vehicle if the
food does not enter U.S. distribution.
©2021 PEB Commodities, Inc.Who will set the requirements
• The shipper will set or assign the
requirements.
“The key... is that the new
law explicitly places primary • The shipper is defined as a person,
responsibility for food e.g., the manufacturer or a freight
safety and prevention on broker, who arranges for the
food producers and transportation of food in the US by a
processors.” carrier or multiple carriers
sequentially.
• The person who arranges for
transportation of food by a carrier is
best suited to perform functions of a
shipper, for example a broker, as
long as they have, or obtain, the
necessary food safety information
Former FDA Deputy Commissioner (§1.904).
Michael R. Taylor
©2021 PEB Commodities, Inc.Recap of Sanitary Transportation Safety
Definitions
Shipper • The one who arranges for
transportation
• The one who prepares for
Loader
transport and loads the trailer
• The one who physically moves
Carrier
the food by motor transport
• The one who receives the load
Receiver
after transport
© 2016 PLM Trailer Leasing confidential and proprietary ©2021 PEB Commodities, Inc.Sanitary requirements
• Shipper must specify to carrier and,
when necessary, the loader, in writing,
all necessary sanitary specifications for
the carrier's vehicle and transportation
equipment including any specific design
specifications and cleaning procedures.
• One-time notification is sufficient
unless design requirements and
cleaning procedures required for
sanitary transport change based upon
type of food being transported, in
which case the shipper shall so notify
the carrier in writing before the
shipment.
©2021 PEB Commodities, Inc.Sanitary Transportation of Food Carrier
Concerns
Do carriers know what risks they are assuming when
they sign a written agreement with their shipper?
• Responsibility
• Achievable & Acceptable?
• Temperature control
• Temperature Records Exchange
• Training
• Record retention
• Sanitary condition
• Written procedures
• Pre-cool requirements
• Equipment specification per shipper
©2021 PEB Commodities, Inc.Sanitary requirements
• The shipper may rely on contractual
agreements to assign some responsibilities
to other parties, such as a loader or carrier,
if they agree to accept the responsibility.
• If a task under this rule is assigned via
contract to a party who is not covered by
the rule, FDA would hold the party covered
by the rule ultimately responsible for
compliance with the provisions of the rule.
• The shipper establishes delegable duties
and obligations to be performed by the
carrier.
The “carrier” needs to determine if the shipper defined duties and
obligations are quantifiable, achievable and acceptable.
©2021 PEB Commodities, Inc.Sanitary Requirements
As such, the rule will similarly apply sanitary maintenance requirements to
food transportation vehicles and equipment as such requirements have
been and will continue to be applied to equipment and utensils that are
used to produce food in facilities.
©2021 PEB Commodities, Inc.How Do You Define a Clean Transit Vehicle?
• How clean is clean?
– Visual - sweep it!
– Odor - smell it!
– Microbiological - test it!
– Chemical - test it!
– Physical - inspect it!
– Processing plant clean!
• Reefer equipment corrosion
©2021 PEB Commodities, Inc.Equipment Design and
Cleaning
• Vehicles and transportation
equipment that are poorly designed
can be a source of contamination of
food during transport.
• The Sanitary Transportation of Food
Rule requires that the design of
vehicles and transportation
equipment used in transportation
operations, the materials used in
their manufacture, and their
workmanship be suitable and that
they be adequately cleanable.
How do shippers define “how clean is clean” with respect to
the trailer, railcar or container and the refrigeration unit?
©2021 PEB Commodities, Inc.Equipment Design and Cleaning
• For example, food contact surface coatings on
vehicles or transportation equipment that are not
corrosion resistant or are flaking or chipping
could contaminate food due to chemical
contamination or by causing the food to become
unfit, and would render the vehicle or equipment
as not suitable for their intended use.
©2021 PEB Commodities, Inc.Case Study
Clean Reefer
Adulterated Food
Investigation
• Corrosive agents used
• Multiple stack train shipments of frozen pork
• Surface oxidation of interior aluminum alloy
components from the refrigeration unit and the
interior components within the reefer box
• White powder (aluminum oxide) on cartons
©2021 PEB Commodities, Inc.Case Study
Clean Reefer
Adulterated Food
Investigation (con’t)
Equipment Corrosion White Powder on Cargo
©2021 PEB Commodities, Inc.Case Study
Clean Reefer
Adulterated Food
The Rest of the Story
• USDA declared all shipments of frozen pork adulterated
• 860, 000 lbs. of pork adulterated & destroyed
©2021 PEB Commodities, Inc.Equipment Design and Cleaning
• Wood used to hold raw meat or poultry
during transportation typically cannot be
brought to a sanitary condition to hold ready
to consume produce during transportation
due to the potential for the wood to retain
contaminants such as harmful
microorganisms in its porous structure.
©2021 PEB Commodities, Inc.Sanitation
Yersinia enterocolitica – Contaminated Totes
• 36 children affected
• 16 appendectomies
• Traced to recycled
container
• Inadequate sanitation
Ensure that the pallets, containers and/or
bins are clean before using them to
transport fresh foods.
©2021 PEB Commodities, Inc.Equipment maintenance, sanitation, airflow and
temperature management issues
©2021 PEB Commodities, Inc.Wood Floor Plenum
©2021 PEB Commodities, Inc.Equipment Design and Cleaning
Equipment and utensils in food plants must be properly
maintained. As such, the proposed rule would similarly
apply sanitary maintenance requirements to food
transportation vehicles and equipment
Will shipper’s sanitary maintenance requirements and caustic
cleaning chemicals used for food processing plants damage
transportation vehicles and equipment?
©2021 PEB Commodities, Inc.Guidance: Sanitary Refrigerated Equipment
Warm soapy water
The use of corrosive chemicals to clean
refrigerated equipment are detrimental.
©2021 PEB Commodities, Inc.Food Safety Training
• The rule requires that carriers
provide training to personnel
engaged in transportation
operations that provides an
awareness of potential food safety
problems that may occur during
food transportation and basic
sanitary transportation practices to
address those potential problems.
©2021 PEB Commodities, Inc.Is Training Necessary?
• The FDA puts substantial emphasis on training of
personnel and maintaining records.
• Who should be trained?
– Executives, owners, dealers, sales, booking, operations, drivers,
M&R, loss prevention & claims?
Human error accounts for up to 80% of cargo losses
during transport.
©2021 PEB Commodities, Inc.Guidance: Food Safety Training
• FDA envisions 1 to 4 hour driver
food safety training course.
• Must maintain food safety training
record for 12 months beyond
driver leaving the position.
• Keep up to date with the FDA
website for the latest information
on driver food safety training to
meet compliance.
©2021 PEB Commodities, Inc.Documentation for Compliance
Telematics is your best solution
Documentation for compliance may be accomplished by any
appropriate means agreeable to the carrier and shipper such as
the carrier presenting printouts of a time/temperature recording
device or a log of temperature measurements taken at various
times and locations during the shipment.
©2021 PEB Commodities, Inc.Temperature Requirement
A carrier must demonstrate to the
shipper (if requested) and to the
receiver (if requested) that it has
maintained temperature conditions
during the transportation for food
safety as specified by the shipper.
©2021 PEB Commodities, Inc.Pasteurized Crab
Case Study
©2021 PEB Commodities, Inc.Botulism
• According to the FDA and others, “There is a safety
concern with crabmeat because there is an increased
potential for the formation of Clostridium botulinum
(“C. botulinum”) toxin before spoilage makes the product
unacceptable to consumers. When C. botulinum grows, it
can produce a potent toxin, one of the most poisonous
naturally occurring substances known.
• The C. botulinum toxin formation can result in consumer
illness and death. It is the toxin responsible for botulism.
Everyone is susceptible to intoxication by C. botulinum
toxin; only a few micrograms of the toxin can cause illness
in a healthy adult. Mortality is high; without the antitoxin
and respiratory support, death is likely”.
©2021 PEB Commodities, Inc.Pasteurized Crab
Case Study
• Crab Shipped to New Orleans
• Buyer’s HACCP Plan
– Transportation was Purportedly Included
– Carrier Was Never Informed
• Investigation
– Cargo Looked & Smelled Good
– Lab Tests Were Okay
– Alleged Temperature Management Issues
– No Portable Temperature Recorders
– Temperatures High per Micro-p Download
©2021 PEB Commodities, Inc.The Bottom Line
• Botulism was a major concern
(Clostridium botulinum)
• Germination, growth, and toxin formation
• The ‘Skinner and Larkin Curve’ was referenced
to determine minimum times and temperatures
for C. botulinum growth and toxin formation
©2021 PEB Commodities, Inc.The Bottom Line
• Serious food safety implications due to potential
growth of anaerobic microbes & Botulism toxins
– a few nanograms of toxin can cause illness (one
billionth of a gram)
• Cargo was Destroyed
• Receiver Filed Federal Lawsuit Against Carrier
One billionth of a gram equals 3.52739619 × 10-11 ounces
©2021 PEB Commodities, Inc.The Moral of the Story
• Carriers are no longer exempt from FDA
regulations.
• Carrier must have temperature and
diagnostics records from the refrigerated
unit to protect itself, especially when the
burden of proof of a loss shifts to the
transporter when the shipper has good
records and the transporter has little or
none.
©2021 PEB Commodities, Inc.Reminder
• “If You Don’t Measure It … You Can’t
Manage It”
• “If You Don’t Record It … You Won’t
Remember It”
©2021 PEB Commodities, Inc.Killer Broccoli
• It’s pesticide poisoning!
• Two workers lost consciousness
while installing cargo restraining
devices & were sent to hospital.
• Cause of problem was thought to be
broccoli tainted with pesticides.
©2021 PEB Commodities, Inc.Bottom Line
• Broccoli was not tainted with ag
chemicals.
• The trucker’s GPS tracking and
excellent temperatures confirmed
cargo was stuffed hot.
©2021 PEB Commodities, Inc.Bottom Line
(Continued)
• Broccoli produces substantial
amounts of carbon dioxide. (“CO2”)
• The cause of the unconsciousness
was exposure to elevated CO2.
Broccoli generates 4-fold more CO2 at 50 °F than at 32 °F
©2021 PEB Commodities, Inc.Bottom Line
(Continued)
Death is imminent when exposed to
20% CO2. You will rapidly fall
unconscious or into a coma.
Convulsions are likely to
occur. Death will follow, usually by
asphyxiation, because the CO2
prevents blood from carrying oxygen
into the bloodstream.
©2021 PEB Commodities, Inc.Bottom Line
(Continued)
The trucker’s advanced technology
and excellent record keeping saved
the day.
If the broccoli was tainted, industry
impact was projected at $1 billion
dollars.
©2021 PEB Commodities, Inc.Pharmaceutical
• A chilled pharmaceutical item was
shipped in a reefer trailer.
• A portable temperature device
recorded temperatures below
freezing point of the pharmaceutical
for less than an hour.
• Cargo was assumed damaged due to
freezing and was discarded.
©2021 PEB Commodities, Inc.Bottom Line
• The trucker’s insurance company
claimed that the cargo was not
frozen and that air temperatures were
not the same as product
temperatures.
• This two million dollar dispute was in
litigation for years.
©2021 PEB Commodities, Inc.Common Denominators
Case Studies
• Human error & flawed decision making
• Limited product knowledge & in-process
controls
• Inadequate record keeping & traceability
• No in-transit portable recorders or product
temperatures
• Limited temperature validation studies
©2021 PEB Commodities, Inc.Common Denominators
Case Studies
(Continued)
• Losses not demonstrated vis a vis
quality, safety and efficacy of the
pharma items.
• Whether “real or perceived”, cold
chain losses have a significant
impact on profits.
©2021 PEB Commodities, Inc.FSMA Preventive Controls Rule for Human Food
Proactively prevent problems
before they start.
Re-actively try to figure out
where the problem started.
©2021 PEB Commodities, Inc.FSMA Preventive Controls for Human Food
This rule is final. The first compliance date began September 19, 2016
for the majority of food processors. A Food Safety Plan prepared by a
Preventive Controls Qualified Individual (PCQI) is required.
The final rule implements the requirements of FSMA for covered
facilities to establish and implement a food safety system that
includes hazard analysis and risk-based preventive controls. The rule
establishes requirements for:
• A written food safety plan;
• Hazard analysis;
• Preventive controls;
• Monitoring;
• Corrective actions & corrections;
• Verification;
• Supply-chain program;
• Recall plan; and
• Associated records
©2021 PEB Commodities, Inc.What do HACCP & HARPC Mean?
Hazard Analysis Comparison
• HACCP: Hazard Analysis Critical Control Point
– Focus = critical control points (CCPs)
– Builds on existing prerequisite programs (PRPs)
– Analyzes potential hazards based on existing programs
– Establishes CCPs to control remaining significant risks, after
PRPs are effectively implemented
• HARPC: Hazard Analysis and Risk-based Preventive
Controls
– Focus = All Preventive Controls
– Analyzes potential hazards to consumers
– Identifies measures to control those hazards (CCP or other)
– Manages controls for any “significant hazards” / “hazards
requiring a preventive control,” in a manner similar to a CCP
©2021 PEB Commodities, Inc.Preventing
Food Poisoning
HACCP & HARPC
A systematic approach to
the identification,
evaluation, control &
prevention of food safety
hazards.
.
©2021 PEB Commodities, Inc.HACCP – 7 Step Plan
Identify control mechanisms Keep accurate records of
for each hazard everything for future reference
Decide where hazards Decide what to do when
could occur control exceeds safety limits
Hazard Critical Critical Corrective Record
Monitoring Verification
Analysis Control Pts Limits Action Keeping
Review process from raw material Continual review of HACCP
to final product to ensure it is effective
Determine monitoring methods for
each control mechanism
Source: Dr. Patrick Brecht
©2021 PEB Commodities, Inc.Preventive Controls for Human Food
Carrier Concerns
• This portion of the rule requires registered food facilities to
maintain a food safety plan, perform a hazard analysis, and
institute preventive controls for the mitigation of those hazards,
unless an exemption applies.
• Facilities must also monitor their controls, conduct verification
activities to ensure the controls are effective, take appropriate
corrective actions, and maintain records documenting these
actions.
Refrigerated transportation practices and
requirements need to be defined.
©2021 PEB Commodities, Inc.Preventive Controls for Human Food
Carrier Concerns
The FDA expects a facility that identifies
temperature control, including during
transportation, as a preventive control
(whether or not as a CCP), to
communicate the need for appropriate
temperature control to the person
transporting it.
Whether a particular facility
identifies food transportation as a
critical control point through its
hazard analysis would depend on
the circumstances, such as whether
the food is a Time/Temperature
Control for Safety (TCS).
©2021 PEB Commodities, Inc.Preventive Controls for Human Food
Carrier Concerns
• Evaluation of whether a Hazard Requires a Preventive Control. We also
proposed that the hazard evaluation must consider the effect of the
following on the safety of the finished food for the intended consumer:
(1) The formulation of the food;
(2) the condition, function, and design of the facility and equipment;
(3) raw materials and ingredients;
(4) transportation practices;
(5) manufacturing/processing procedures;
(6) packaging activities and labeling activities;
(7) storage and distribution;
(8) intended or reasonably foreseeable use;
(9) sanitation, including employee hygiene; and
(10) any other relevant factors (proposed § 117.130(c)(2)).
Do you have an existing/detailed HACCP plan for refrigerated
food transportation practices?
©2021 PEB Commodities, Inc.Preventive Controls for Human Food
Initial Carrier Concerns:
Who is writing your Facility’s Food Safety Plan
(HACCP/HARPC)?
Hazard Analysis and
Preventive Controls
– Sec. 103
When will you tell the carrier what your
HACCP/HARPC transportation requirements
Final Rule are?
Published:
September 15, 2015
Will I be asked to be part of your Food Safety
(HACCP/HARPC) Planning Team?
Why Shippers (Facilities) Need to Talk to Their Carriers.
©2021 PEB Commodities, Inc.Preventive Controls for Human Food
Initial Carrier Concerns:
What are your intentional adulteration
compliance requirements?
Intentional
Adulteration / Food
Defense Plan (IA) –
Sec. 106 How did you determine your risks of
intentional adulteration during
refrigerated transportation?
Final Rule
Published:
May 31, 2016
How did you determine that your
compliance requirements are adequate
solutions for your transportation risks?
©2021 PEB Commodities, Inc.Dr. Brecht’s Perspective
Retailers
Consumer
Litigation Pressures
Adoption
of
Transport
Media
Commercial Food
Safety
Measures Brand
Enhancement/
Government Protection
Market forces will continue to raise the Food Safety bar in addition
to government regulations.
Source: Dr. Patrick Brecht ©2021 PEB Commodities, Inc.Acknowledgments
A special note of appreciation to Mr. Leonard Rodowick (Formerly
Strategic Relations – Food Safety and OEMs, Thermo King Corporation)
and Mr. Don Durm (PLM Trailer Leasing, Vice President , Strategic
Customer Solutions) for their collaboration, contributions and support in
the construction of this presentation.
Dr. Brecht and the Carriage of Goods Committee also thank and
acknowledge Lucas D. Bradley, Partner at Bouhan Falligant, Savannah,
GA for preparing the Appendix of Materials.
©2021 PEB Commodities, Inc.You can also read
