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Simplifying Food Regulation

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Sanitary Transport of Human and Animal Food
Businesses involved in the transportation of food in the US must follow 'Sanitary Transport' rules to ensure the food does not become unsafe during travel.

Businesses involved in the transportation of food in the US must follow 'Sanitary Transport' rules to ensure the food does not become unsafe during travel.

Applicability

The "Sanitary Transport Rule" applies to nearly every businesses involved the transportation cycle.

To understand the requirements for your business, assess what role(s) your business plays in the transportation process and review the requirements below.

You can click  to see the requirements for that specific role

Carrier: A person who physically moves food by rail or motor vehicle in commerce within the US (excluding parcel delivery services).

Shipper: A person who arranges for the transportation of the food by carriers.

Loader: A person who loads food onto a motor or rail vehicle as part of the transportation operation.

Receiver: a person who receives food in the US, regardless of whether it is the final destination of that food.

Source


Exemptions:

The following is a list of exemptions to the Sanitary Transport of Human Food regulations:

Non-Covered Businesses:

Certain small businesses are exempt from this rule. There are two ways to achieve the "non-covered business" exemption:

1. A business that is not a motor vehicle carrier (i.e. doesn't physically transport food themselves) and employs fewer than 500 full time employees.

2. A motor vehicle carrier that is not a shipper (i.e. doesn't arrange for shipping of food by other carriers) and has <$27.5 million in annual receipts.

Other Exemptions

The following operations are exempt from this rule:

  • Transportation activities performed by a farm.

  • Food that is merely passing through the US on its way to another country.

  • The transportation of food that is regulated entirely by the USDA.

  • Transportation of the following products:

    • Food gases

    • Food contact substances.

    • Food that is completely enclosed by a container and does not require a temperature control for safety (i.e. a refrigerated food).

    • Live animals, excluding shellfish (they are not exempt)

    • food byproducts that will be used for animal food without further processing.

Waivers

A company may apply for a waiver to waive a specific requirement in this subpart. You can learn more about waivers in 21 CFR §1.914


What are the Requirements for Sanitary Transport?

The goal of this regulation is to ensure that food does not become unsafe during transportation. In order to protect food, all parties involved in transportation must adhere to the following general rules. Additionally, there are rules specific to shippers, carriers, loaders and receives, listed below.

General Requirements:

Protect food from contamination from other items in the same load. It's important that food doesn't get contaminated from other food (i.e. raw fish in the same truckload) or non-food (chemicals that are being shipped in the same truckload). Some ways to do this include:

  • Segregation - physically separate items that could contaminate one another

  • Use of packaging - Use packaging to protect food from contamination



Protect food that is transported in bulk-vehicles or not completely enclosed by a container. For example, if you are shipping a tanker full of milk (bulk-vehicle) or an open truck bed full of corn (no enclosed container) then it must be protected from contamination.

Control the temperature of food that requires it. If a food requires refrigeration or freezing, then this must be maintained during transportation.

If the food is exposed to temperatures that render the food unsafe (i.e. the refrigerator in a truck fails during transport), then the food may not be sold or distributed. However, If a qualified individual (someone with adequate training) determines that the food was not rendered unsafe by this deviation, then the food may be sold and distributed.

Consider the type of food and the stage of production. It's important to understand whether the nature of the food (human food or pet food) when determining how you will keep it safe. Additionally, you should understand the production stage: is the food going to be further processed or is it on it's way to a supermarket?

Food that is going to undergo additional inspections and processing may not need to be transported under as strict conditions than if it is being transported directly to the consumer. For example, The carrier may assess that a truck full of corn can be exposed to a certain amount of dirt during transportation because it is being shipped to a cannery that has agreed to wash it prior to further processing.

Source: CFR §1.908

Specific Requirements:

There are specific requirements for the actors involved in transportation. Note that an entity subject to these requirements may re-assign them in writing to another party.

For example, let's say the shipper is a meal-kit service that delivers meals in individual refrigerated coolers loaded with dry ice. In turn, the shipper doesn't have to pay the expensive cost of refrigerated transportation, since each package is itself refrigerated. Instead, they can ship via a carrier who operates un-refrigerated trucks. Whereas the requirement in this section states that the carrier is responsible for maintaining the proper temperature of the food, they may assign this responsibility to the shipper, who is clearly responsible for making sure each product is packaged with enough ice and in the right container to arrive sufficiently cold.


Requirements for Shippers:

A shipper is the person who arranges for the transportation of food by a carrier (who physically transports the food on trucks/rail). The shipper must do the following:

  • Inform the carrier of all necessary sanitary specifications required to keep the food safe during transportation. This may be a specific design requirement for a carrier's vehicle or a cleaning procedure required to keep the food safe.

  • Inform the carrier of the temperature requirement for the food during transportation. This must be written.

  • Implement written procedures that prevent the food from becoming unsafe during transportation. Although the shipper must develop these procedures, they may be enacted by another party during the transportation process (i.e. the carrier), and this must be agreed upon in writing. For example, if the shipper requires the temperature of their product to be taken and recorded every 24 hours throughout transportation, then the carrier and the receiver may complete this task.

  • If food is being shipped in bulk (i.e. a tanker full of milk), then the shipper must develop written procedures to make sure the previous cargo doesn't make the food unsafe.

  • If the food requires temperature control (i.e. refrigeration) then the shipper must have written procedures to ensure the food is transported under adequate temperature.

Source 21 CFR -- 1.908(b) Requirements applicable to shippers

Record keeping Requirements for Shippers:

Shippers must maintain the following records and provide them to officials upon request. These records (digital or paper) should be kept for at least 12 months beyond their applicability (i.e. 12 months the end of the contract or the discontinuation of a particular activity).

  • Records that the shipper provides specifications and operating temps to carriers

  • All written procedures and policies

  • The assignment of any responsibility to another party

Source 21 CFR -- 1.912


Requirements for Loaders:

  • Before loading food that isn't enclosed in a container, the loader must determine that the vehicle is appropriate to transport the food safely. This could be a visual inspection to ensure the truck doesn't have pest infestation or filth that would make the food unsafe.

  • Before loading the food that requires temperature control, the loader must confirm that the refrigerated area is properly cooled and sufficiently clean to transport the food safely.

    Source 21 CFR -- 1.908(c) Requirements applicable to loaders


Record Keeping Requirements for Loaders:

Loaders must maintain records of any written agreements that assigns tasks required by this regulation. These records (digital or paper) should be kept for at least 12 months beyond their applicability (i.e. 12 months the end of the contract or the discontinuation of a particular activity). These records must be provided to officials upon request.


Requirements for Receivers:

Upon receipt of food requiring temperature controls, the receiver must assess whether the food was subject to temperature abuse (i.e. a safe temperature was not maintained during transport.) This could be achieved by one of the following measures.

  • Taking the temperature of the product upon arrival

  • Taking the temperature of the vehicle's refrigerated space upon arrival.

  • Visually inspecting the food - consider how easy it is to tell if ice cream has melted and been re-frozen.

  • Smelling it - products subject to temperature abuse may produce foul odors.

Source 21 CFR -- 1.908(d) Requirements applicable to receivers


Record Keeping Requirements for Receivers:

Receivers must maintain records of any written agreements that assigns tasks required by this regulation. These records (digital or paper) should be kept for at least 12 months beyond their applicability (i.e. 12 months the end of the contract or the discontinuation of a particular activity). These records must be provided to officials upon request.


Requirements for Carriers:

  • The carrier's equipment/vehicles must meet the shippers specifications for keeping food safe.

  • The carrier must demonstrate to the receiver that they maintained the agreed upon temperature conditions during transportation. This could be the product's temperature at loading, unloading and at various intervals during transportation.

  • The carrier must pre-cool any refrigerated vehicle before transporting food.

Source 21 CFR -- 1.908(e) Requirements applicable to carriers

Requirements for Carriers who use bulk-vehicles

A bulk-vehicle means food is stored openly in a bulk container, such as a tanker full of milk or a truck bed full of loose ears of corn

  • The carrier must be able to provide information to the shipper about the identity of the previous cargo.

  • The carrier must be able to provide information to the shipper describing the most recent cleaning of the bulk-vehicle.

Training Records for Carriers

  • When a carrier is responsible for sanitary conditions during transportation, they must train their staff to be aware of and address potential problems that may arise.

  • Carriers must have records documenting the training that includes: the date of the training, type of training, the persons trained.

Source -- 21 CFR 1.910

Record Keeping Requirements for Carriers:

Carriers must maintain the following records and provide them to officials upon request. These records (digital or paper) should be kept for at least 12 months beyond their applicability (i.e. 12 months the end of the contract or the discontinuation of a particular activity).

  • The written procedures for cleaning, sanitizing, and (if applicable) inspecting their equipment/vehicles

  • The written procedures for maintaining temperature control.

  • The written procedures for maintaining bulk-vehicles.

  • Training Records

  • Any other written agreements that assigns tasks required by this regulation.

Source -- 21 CFR 1.912