FDA FOOD SAFETY MODERNIZATION

ACT (FSMA): THE SERIES PART 3

After 11 years of work, on April 6th, 2016, the FDA published the Final Rules regarding the Sanitary Trans-

portation of Human and Animal Food (“STHAF” or “Rule”). The Rule apply to Shippers, Receivers, Load-

ers, and Carriers engaged in transportation operations for food whether or not the food is offered or enters

interstate commerce. It also includes foreign entity that ship food into the U.S. for later consumption or

distribution in the U.S.

Below is a quick reference to the key changes that will affect Motor Carriers. We recommend that everyone

read the complete Rule for their own knowledge *see bottom of this post*

Not Applicable The STHAF does not apply to all food in transit. The industry segments that by-pass these Rules are the

following:

The Rules DO NOT apply to the transportation of frozen food.

It does not apply to transportation of: food fully enclosed by a container (unless requiring temperature

control for safety); live food animals (except molluscan shellfish); and compressed food gases.

It’s not intended to apply to the transportation of food imported for future export, and is neither con-

sumed nor distributed in the United States (e.g., From Mexico, through the US, and on to Canada).

Does not apply to transportation activities performed by farm.

Does not apply to human food byproducts transported for use as animal food that will not be subject to

further processing (i.e., feed moved directly to the farm where it will be fed directly to livestock)

Definitions The Rule has expounded on duties of those involved in the transportation process. These changes add

roles and clarify others.

“Loaders” have been added as a covered party.

Loader means a person that loads food onto a motor or rail vehicle during transportation

operations. This role can be filled by an employee of the Motor Carrier (i.e. the Driver), the Ship-

per, or a third party (i.e. warehouseman)

Before loading food not completely enclosed by container onto a vehicle, the Loader must visually

inspect the vehicle or equipment to determine if it in in appropriate sanitary condition.

Before loading food that requires temperature control for safety, the Loader must verify the specifi-

cations provided by the shipper.

Brokers are now considered a “Shipper” under the Final Rule.

Shipper means a person, e.g., the manufacturer or a Freight Broker, who arranges for the

transportation of food in the United States by a carrier or multiple carriers sequentially.

June 2016

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Contents

Not Applicable

Definitions

Contracts

Operational

Requirements

Training Requirements

Compliance Dates

When to Find the Rule

and More Info

Contracts The STHAF identify the Shipper as the responsible party for the safety of the food in transit. Because of

this distinction, the contracts between Motor Carriers and Shippers (including Brokers) will have a lot

more information and requirements regarding the standards of sanitary conditions.

Shippers of temperature controlled food must implement written procedures to ensure food is trans-

ported under adequate temperature control and that vehicles and equipment are in adequate sani-

tary condition.

The Shipper must specify to the Carrier, and when necessary, the Loader, in writing, all necessary

sanitary requirements for the Carrier’s vehicle and transportation equipment. One-time notification

is sufficient, unless design requirements and cleaning procedures change based upon the food

being transported.

Operational Requirements Though the contracts will specify what is required of the Motor Carrier, carriers should be prepared for

the following:

Carriers must provide vehicles and transportation equipment that meet the Shipper’s specifications

and otherwise appropriate to prevent food from becoming unsafe.

Carriers must provide to the Shipper and, upon request, to the Receiver the operating temperature

specified by the Shipper, and if requested, demonstrate it has maintained temperature conditions

during transport that are consistent with the operating temperature specified by the Shipper.

Carriers must pre-cool units to the specifications provided by the Shipper.

For bulk vehicles, if requested by the Shipper, Carriers must provide the Shipper with information

regarding the previous cargo carried in the vehicle as well as the most recent cleaning of the vehi-

cle.

If a covered entity at any point in the transportation chain becomes aware of a possible material failure

of temperature control or any other condition that may render a food unsafe, that food must not be sold

or distributed until a determination of safety is made by a qualified individual.

*FDA comments on a qualified individual: “Whomever makes such a determination should be qualified

by training or experience to make such a determination, i.e., he should have a scientific understanding

of how the temperature deviation could affect the growth of pathogens or production of toxins in the

food.”*

Training Requirements With the new standards of sanitation, Motor Carriers will be required to have proper training in food safety and

handling.

The Carrier must develop and implement written procedures that:

Specify practices for cleaning, sanitizing if necessary, and inspecting vehicles/equipment the Carrier

provides;

Describe how it will comply with provisions for temperature control; and

Describe how it will comply with provisions for use of bulk vehicles.

Carriers must provide training to personnel engaged in transportation operations when the Carrier and

Shipper have agreed in a written contract that the Carrier is responsible for sanitary condition during

transportation operations. The training should include:

An awareness of potential food safety problems that may occur during transportation;

Basic sanitary transportation practices to address those potential problems; and

The responsibilities of the Carrier under the Rules.

Carriers must establish and maintain records documenting the training. The records must include the

date of the training, the type of training, and the person(s) trained. These records must be retain for a

period of 12 months beyond when the procedures are put into use, or the person identified in any such

records continues to perform the duties for which the training was provided.

*The FDA plans to develop a web-based training course. Carriers would be able to print a copy of a cer-

tificate of participation in the course to satisfy the requirement of § 1.910*

Compliance Dates The Final Rules were effective June 6th, 2016. The compliance dates will be staggered as follows:

“Small Businesses” will have two years to comply (June 6th, 2018)

Small Businesses - businesses other than Motor Carriers who are not also Shippers and/or

Receivers, that:

-Employing fewer than 500 persons

-Motor Carriers having less than $27.5 million in annual receipts

“Other Businesses” will have one year to comply (June 6th, 2017)

Other Businesses - a business that is not small and is not otherwise excluded from coverage

would have to comply one year after the publication of the Final Rule.

Dawson Transportation Services would like to thank Jonathan Stringer and Great West Casualty Company for

their continuous efforts in helping, defending, and informing the transportation industry. We appreciate their

time and energy.

Where to Find the Rule and More Information For more information: Click Here

To get a copy of the Final Rule (you should read the Rule): Click Here

To contact FDA about the Food Safety Modernization Act and find the online form for submitting questions:

Click Here