MARK OLDHAMAssistant Vice President

Senior Loss Control Consultant303.414.6445

mark.oldham@lockton.com

Good Enough to EatImplementing 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 FINNLoss Control Consultant

404.460.0749jfinn@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

128,000to be hospitalized

and claims

3,000 lives annually

An overview of the Food

Safety Modernization

Act (FSMA) is covered

in a previous Lockton

White Paper.

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.

September 2016 • Lockton Companies

3

REQUIREMENTS1. 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

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).

September 2016 • Lockton Companies

5

CARRIER RESPONSIBILITIESWhen 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:

h Provide the operating temperature specified by the shipper.

h 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:

h Food safety awareness.

h Basic sanitary transportation practices.

h The carrier’s responsibilities.

� Upon hire and as needed thereafter.

� Establish and maintain records of the training.

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RECORDSShippers 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.

WAIVERSThe 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.

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 FOOD1. 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.

© 2016 Lockton, Inc. All rights reserved. g\White Paper\Oldham\2016\Oldham_Food Safety_Sept 2016.indd:22571

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