In April 2016, FDA published its final rule for the Sanitary Transportation of Food (STF). The rule, which became effective on June 6, 2016, established requirements for shippers, loaders, carriers by motor or rail vehicle and receivers involved in transporting human (and animal) food to use documented sanitary practices to ensure the safety of that food.

The goal of the final STF is to prevent practices during transportation that create food safety risks, such as failure to properly refrigerate food, inadequate cleaning of vehicles between loads, and failure to properly protect food.

Pennsylvania Department of Agriculture (PDA) adopts the new federal regulations as dictated by the Food Safety Act (3 Pa. C.S.A. §5733(f)) and will enforce all applicable provisions. During inspection of food establishments subject to this rule, PDA will assess their transportation operations and practices to make sure required plans are being implemented properly. PDA will work with and assist these firms to understand and comply with the new regulations.

The full ruling can be found in the Federal Register.

Who is covered?

With some exceptions, the final 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. It also applies to foreign shippers who ship food into the U.S. directly by any means (e.g. motor, rail, ship, air) and arrange for the transfer of the intact container onto motor or rail vehicle for transportation within the U.S., if that food will be consumed or distributed in the United States.

Companies involved in the transportation of food intended for export are covered by the rule until the shipment reaches a port or U.S. border.

Exemptions

• Shippers, receivers, loaders 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 U.S. to another country;
  
• Transportation of food that is imported for future export and that is neither consumed or distributed in the U.S.;
  
• Transportation of compressed food gases (e.g. cylinders of carbon dioxide, nitrogen used in food and beverage products), and food contact substances;
  
• Transportation of human food byproducts 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 (TCS food).
  
• Transportation of live food animals, except molluscan shellfish.

Waivers

In April 2017, the FDA published three waivers for businesses whose transportation operations are subject to Federal-State or local controls. They include:

Businesses that hold valid permits and are inspected under the National Conference on Interstate Milk Shipments’ Grade “A” Milk Safety Program, only when engaged in transportation operations involving bulk and finished Grade “A” milk and milk products.

Businesses that are permitted or otherwise authorized by the regulatory authority to operate a food establishment that provides food directly to consumers (including restaurants, retail food establishments, and nonprofit food establishments), only when engaged in transportation operations as:

Receivers, whether the food is received at the establishment itself or at a location where the authorized establishment receives and immediately transports the food to the food establishment;

Shippers and carriers in operations in which food is transported from the establishment as part of the normal business operations of a retail establishment, such as:

delivery of the food directly to the consumer(s) by the authorized establishment or a third-party delivery service or;

delivery of the food to another location operated by the authorized establishment or an affiliated establishment where the food is to be sold or served directly to the consumer(s).

Businesses that are appropriately certified and are inspected under the requirements established by the Interstate Shellfish Sanitation Conference’s National Shellfish Sanitation Program (NSSP), only when engaged in transportation operations involving molluscan shellfish in vehicles that are permitted by the State NSSP certification authority.

Compliance Dates

The compliance date for Large businesses began in April 6, 2017. All other covered businesses will have to comply with the rule by April 6, 2018.

Key Requirements

The rule identifies shippers as having the primary responsibility in determining appropriate transportation operations. Shippers may rely on contractual agreements to assign some of the responsibilities to other parties. The FDA defines ‘shipper’ as a person (such as the manufacturer or a freight broker) who arranges for the transportation of food in the United States by a carrier or multiple carriers sequentially.

The rule requires that shippers develop and implement written procedures to ensure:

Vehicles and transportation equipment: Vehicles and equipment are properly designed, maintained and in appropriate sanitary condition to ensure that it does not cause the food that it transports to become unsafe.

Transportation operations: measures taken during transportation to ensure food safety, such as adequate temperature controls, preventing contamination of ready to eat food by raw food, protection from food contamination by non-food items in the same load or a previous load on the vehicle, and the protection of food from cross-contact, i.e., the unintentional incorporation of a food allergen.

Training: Training of carrier personnel in the awareness of potential food safety problems and basic sanitary transportation practices required by the rule, and documentation of the training. This training is required when the carrier and shipper agree that the carrier is responsible in whole or part, for sanitary conditions during transport.

FDA has developed a free training module for carriers to help them meet the STF requirements. The online course can be found on FDA website.

Carriers may elect either to use this module as a means of satisfying the minimum requirements, to train their own personnel or to acquire training through third party training vendors and or use.

Records: Maintain records of shipper-to-carrier communication, written procedures, agreements and training (required of carriers). The required retention time for these records depends upon the type of record and when the covered activity occurred, but except for training documentation, does not exceed 12 months.

The final rule allows offsite storage of all records, except for the written procedures required, provided that the records can be retrieved and made available within 24-hours for regulatory review.