The FDA’s final rule on the sanitary transportation of food went into effect June 6, 2016. Though larger carriers, shippers, and receivers should have their compliance plans in place, smaller companies (fewer than 500 employees and less than $27.5 million in annual receipts) still have two years from the rule publication date to comply with the requirements.
This final rule—the sixth of seven rulemakings for FSMA—was based on a combination of the Sanitary Transportation of Food Act of 2005 and about 240 submissions from transportation companies, food safety organizations, consumer advocacy groups, and more.
The rulemaking has been proposed to ensure:
- Proper refrigeration during transportation of foods that require it;
- That vehicles and food storage are adequately cleaned and sanitized; and
- That there is adequate protection for food during transport.
Waivers have been proposed to exempt carriers, shippers, and receivers who hold valid permits and are inspected under National Conference on Interstate Milk Shipments (NCIMS) Grade ‘‘A’’ Milk Safety Program only when they’re shipping Grade A milk and milk products. The exemption should also apply to retail and food service operations that hold valid permits only when they are engaged in transportation operations as receivers, or as shippers and carriers in operations in which food is relinquished to consumers after transportation from the establishment.
Foods that are covered under the ruling includes all FDA-regulated human food and animal (including pet) food, with a few exemptions:
- Compressed food gasses
- Live animals
- Transportation performed by a farm
- Food completely enclosed containers or packaging that doesn’t require Temperature Control for Safety (TCS)
Though the FDA doesn’t have exact numbers or predictions on how this ruling will affect food safety, they have estimated that the total first year cost will be $162.7 million, with the total annual cost estimated at $93.5 million.
Requirements Addressed in the Ruling
Vehicles and Transportation Equipment
All transportation equipment and vehicles used in food transport (not including exemptions) must be adequately cleanable in design and material. Transportation equipment is defined as equipment used in transportation, such as bins, bulk containers, pallets, pumps, loading systems, totes, and more.
Responsibility for making sure food is transported in a safe manner (including temperature controls, measures like segregation or product isolation, and basic sanitary measures like hand washing) must be assigned to a supervisor or a management team. There are also additional concerns for shippers, receivers, and carriers:
Shippers: Must specify the conditions necessary to safely transport food in writing (such as cleaning procedures and temperature controls) to the carrier. Shippers are responsible for the visual inspection of the vehicle and the transportation equipment and must declare that they have been properly cleaned and sanitized. The shipper must also check to ensure that any necessary pre-cooling has taken place.
Shippers and Receivers: Must provide convenient handwashing locations for carrier employees to use when the food products aren’t completely enclosed in containers. Shippers and receivers are also responsible for loading and unloading the food products in a safe and sanitary manner.
Carriers: Must provide a sanitary transportation method for food. They should pre-cool refrigerated units as requested by the shipper, and demonstrate that the appropriate temperature is met, if requested by the shipper.
Procedures must be established for information to be exchanged among shippers, carriers, and receivers. Disclosures about what was previously carried and the cleaning and sanitation measures that were taken are imperative for food safety. For example, information such as possible allergen cross-contact between food the carrier just unloaded and what he or she is about to load is vital to keeping food safe. Sharing such information helps prevent cross-contact and cross-contamination.
The FDA now requires carriers to undergo training if they have an agreement with shippers that they’ll be responsible for the transportation operations. The FDA isn’t prescribing a length to the training, or even specific topics that must be covered. The goal is to raise awareness about food safety procedures; not to train carriers on specific duties.
Shippers and carriers both bear the burden of record-keeping. Shippers must hold specific records that demonstrate they have adequately provided safe transport information to carriers for at least 12 months, though these records may be stored off-site. Carriers must have records for agreements between them and the shippers about the safe transport information for 12 months after the agreements are in effect. They also must have records detailing training for employees involved in food transport, and keep those records for 12 months after the person is no longer performing those duties.
The sanitary transportation of food ruling should affect an estimated 83,609 businesses. The information it contains may not have a predictable outcome on food safety per the FDA, but the administration hopes to improve food safety during transportation by regulating food temperature, cleaning, and sanitation of food transportation equipment and vehicles, and ensuring food is protected during transportation.