Food safety (transportation)

Scope

Shippers of food are required to comply with food safety rules.

Regulatory citations

• 21 CFR Part 1 — General Enforcement Regulations
• 21 CFR Part 11 — Electronic Records; Electronic Signatures

Key definitions

• Food and Drug Administration (FDA): An agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency is also responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
• Food Safety Modernization Act (FSMA): An act implemented to transform the nation’s food safety system by shifting the focus from responding to foodborne illness to preventing it. FDA finalized seven major rules to implement FSMA, recognizing that ensuring the safety of the food supply is a shared responsibility among many different points in the global supply chain for both human and animal food. The FSMA rules are designed to make clear specific actions that must be taken at each of these points to prevent contamination.
• The Sanitary Transportation of Human and Animal Food rule: This rule requires those involved in transporting human and animal food by motor or rail vehicle to follow recognized best practices for sanitary transportation, such as properly refrigerating food, adequately cleaning vehicles between loads and properly protecting food during transportation.

Summary of requirements

The Sanitary Transportation of Human and Animal Food rule. Published in the Federal Register on April, 6, 2016, this rule has an effective date of June 6, 2016. This rule allows the transportation industry to continue to use best practices, i.e., “commercial or professional procedures that are accepted or prescribed as being correct or most effective,” concerning:

• Cleaning,
• Inspection,
• Maintenance,
• Loading and unloading, and
• Operation of vehicles and transportation equipment that it has developed to ensure that food is transported under the conditions and controls necessary to prevent adulteration linked to food safety.

If a driver is part of the delivery of certain products that qualify under the Sanitary Transportation of Human and Animal Food final rule, the drivers and anyone involved in the transportation of the qualified products must receive training and report any condition that could make the product unsafe (food quality such as appearance or texture is not covered under this rule only if the product is unsafe for consumption).

This regulation applies to most customers and carriers involved in the transportation of human or animal food within the United States. The regulations, found at 21 CFR Part 1, cover vehicles and transportation equipment, transportation operations, training, and records.

Requirements in each area:

• Vehicles and equipment.
  • Vehicles and equipment (totes, bins, tanks, pallets, pumps, hoses, etc.) used to transport food must be designed and maintained to be suitable for the transportation of food products and cleanable. The intent is to keep the food being transported from becoming unsafe, contaminated, or adulterated due to using a vehicle or equipment that is not intended for use with food.
  • If the food being transported requires temperature control, the equipment used must designed, equipped, and maintained to provide adequate temperature control during transport.
  • The vehicle and other equipment must be stored in such a way as to prevent the harboring of pests (bugs and rodents) or becoming otherwise contaminated.

• Transportation operations. The shipper is ultimately responsible but can assign responsibility to the carrier to ensure that:
  • Shipper requirements for cleaning and sanitation are met.
  • The vehicle and equipment meet shipper’s specifications and requirements.
  • Shipper requirements for cleaning and sanitation are met.
  • Precooling the vehicle or equipment occurs before loading, if required (shipper is to verify that the temperature is correct before loading).
  • Effective measures are taken to avoid contamination or cross contamination.
  • Food is isolated or segregated to avoid contamination by raw food products or non-food products that are part of the same shipment.
  • The temperature control requirements provided by the shipper are met throughout the trip and proof is provided, if requested. The proof (mechanical temperature tracking, a temperature log completed by the driver, etc.) must meet the shipper’s requirements.
  • Information is provided to the shipper on the previous product carried in the vehicle, if the vehicle is a “bulk vehicle” (a vehicle that carries bulk shipments that are in direct contact with the inside of the vehicle) and the shipper requests the information.
  • Proof is provided as to the most recent cleaning of a bulk vehicle, if requested.
  Carriers must also have written procedures covering:
  • Cleaning, sanitizing, and inspecting vehicles and equipment,
  • The process to monitor and record the temperature of a shipment, and
  • The process to maintain and provide records related to the last shipment and most recent cleaning of bulk vehicles.

Notification of possible unsafe food. If the shipper, loader, carrier, driver, or receiver becomes aware of a failure in the measures to protect the food (such as a temperature deviation or cross contamination), and the failure causes the food to be rendered unsafe:

• That party is responsible for notifying the other parties involved, and
• The shipment cannot be sold or distributed as food any longer.

Exception. The only exception is if a qualified individual can determine that the temperature deviation or other problem did not actually render the food unsafe.

Exemptions. If a carrier is not covered under one of the exemptions below because the operation hauls food that is temperature controlled for safety (not quality), the carrier and the shipper are required to comply with the Sanitary Transportation of Human and Animal food final rule.

The following are exempt from the rule:

• Shippers, receivers, or carriers engaged in food transportation operations that have less than $500,000 in average annual revenue;
• Transportation activities performed by a farm;
• Transportation of food that is transshipped through the United States to another country;
• Transportation of food that is imported for future export and that is neither consumed or distributed in the United States;
• Transportation of compressed food gases (e.g., carbon dioxide, nitrogen, or oxygen authorized for use in food and beverage products), and food contact substances;
• Transportation of human food byproducts transported for use as animal food without further processing;
• Transportation of food that is completely enclosed by a container except a food that requires temperature control for safety; and
• Transportation of live food animals, except molluscan shellfish.

Training. The shipper is responsible for the training of drivers transporting food, unless the shipper’s written agreement with the carrier requires that the carrier provide the training, which must include:

• An awareness of potential food safety problems that may occur during transportation,
• Training on basic sanitary food transportation practices, and
• Training on the requirements of the food safety regulations.

The training will be required upon hire and then as needed thereafter. The carrier will be responsible for maintaining records of the training. The records must include the driver’s name, the date, and the topic.

Records. Shippers and carriers are required by the rules to create and maintain specific records related to the food shipment process. Carriers must maintain records of:

• Any written agreements related to procedures or responsibilities assigned to them by shippers. These must be kept the entire time they are in effect, plus an additional 12 months.
• The procedures that a carrier is, or was, required to have under the regulations as required by a shipper to have and/or follow under the terms of an agreement. These must be kept the entire time they are in effect, plus an additional 12 months.
• Individual driver training records, which are to be kept for the entire time the driver is involved in food transportation, plus an additional 12 months.

The records can be paper or electronic. The records must be made available within 24 hours if requested by an authorized individual. However, the procedures related to cleaning and inspecting of vehicles and equipment must be available onsite where the vehicles are loaded at all times.

It is advisable to review driver training and processes for compliance with the regulation. Also, major shippers should be contacted to better understand their requirements for inspection, cleaning, contamination avoidance, precooling vehicles, and recording the temperature of shipments.