The FDA is now regulating the transportation of food, under the Food Safety Modernization Act.
21 C.F.R. § 1 subpart O and 21 C.F.R. § 11 (electronic records).
Statutory Authority: 15 U.S.C. § 1333, et seq. 19 U.S.C. §1490-91; 21 U.S.C. § 321, et seq.; 42 U.S.C. § 262
Who is covered? Shippers, receivers, loaders, and carriers who transport food. § 1.900(a).
Who is exempt? Farms (b)(3), food completely enclosed by a container that does not require temperature control for safety (§1.906), food that will not be sold or consumed in the United States (b)(1-2), food contact substances, human food byproducts transported for use as animal food without further processing (§1.906), transportation of live food animals (except molluscan shellfish) (§1.906). § 1.900(b).
What equipment is covered? All equipment used in food transportation operations, specifically: bulk and non-bulk containers, bins, totes, pallets, pumps, fittings, hoses, gaskets, loading/unloading systems, detached railcar, and detached trailer. §1.906.
Equipment requirements? Equipment must be designed, suitable for, and adequately cleanable for the safe transportation of food. §1.906(a). Must be maintained in a sanitary condition to prevent the food under transport from becoming unsafe. §1.906(b). Must provide adequate temperature control to prevent the food from becoming unsafe. §1.906(c). Must be stored to prevent pests or other contaminant. §1.906(d).
Shippers. §1.908(b). Maintain and follow written procedures to ensure the sanitary transportation of food. These procedures may be determined by the shipper. The shipper must notify the carrier in writing of the operating temperature and pre-cooling phase, if necessary.
Loaders. §1.908(c). Before loading food, determine that the vehicle and equipment is in appropriate sanitary condition. Before loading food that requires temperature control, determine that the cold storage compartment is adequately pre-cooled, and sanitary.
Carriers. §1.908(d). If the Carrier and Shipper have a written agreement assigning responsibility for sanitary conditions to the carrier: (1) the carrier must ensure the vehicles meet the shipper’s specifications and are appropriate for safe transportation, (2) provide operating temperature data during transportation to the shipper or receiver, upon request. Temperature data can be constant logging, or simply measurements taken upon loading and unloading, (3) pre-cool the refrigerated storage compartment, (4) if requested by shipper, identify the previous cargo transported in any bulk container, (5) if requested by shipper, identify the most recent cleaning of a bulk container, (6) develop and implement written procedures for the following: cleaning, sanitizing, & inspecting transportation equipment, as well as how it will comply with temperature controls and requests for information about bulk containers.
All covered entities. §1.908(a). Possible failure of sanitary controls? In the event of any possible material failure of temperature control or other sanitary controls, all covered entities are required to take appropriate action, which should include prompt notification and supporting documentation, to prevent the sale or distribution of such food, unless a determination is made by a qualified individual the food is safe. §1.908(a)(6).
Can duties and obligations be assigned? Yes, by written agreement, any party may assign its responsibilities to another party. §1.908(a). The written agreement must be stored in compliance with §1.912(e).
Training. §1.910. If the Carrier and Shipper have a written agreement assigning responsibility for sanitary conditions to the carrier, the carrier must provide adequate training to personnel engaged in transportation operations that provides an awareness of potential food safety problems during transportation, basic sanitary transportation practices, and the responsibilities of the carrier. The training must be documented, including the date of the training, type of training, and persons trained.
Shippers: (a) Written agreements and procedures with carriers, specifications & operating temperatures provided to carriers – 12 months beyond termination of the agreement with the carrier.
Carriers: (b) Written procedures – 12 months beyond when the agreements and procedures cease being used in transportation operations. Training records must be kept for 12 months beyond when such employee stops performing related duties.
Carrier To Do List
- Establish a training program for all drivers, loaders, and others responsible for the sanitary transportation of food.
- Establish written procedures for the cleaning, sanitizing, & inspecting transportation equipment, as well as how it will comply with temperature controls and requests for information about bulk containers.
- Review written agreements with shippers of food.
- Review records retention policies to ensure all required records are kept for at least 12 months beyond their useful life, such as termination of the shipper agreement, or separation of employment.
Sample Training Program
TransCert: FDA FSMA Required Training for All Carrier Personnel Engaged in Food Transportation Operations: No Exam ($50). (link)
Course 1: Responsibilities of the Carrier Under the Final Rules (1 hour)
Session 1 covers the Final Rules on the Sanitary Transportation of Human and Animal Foods (now law) as published by the Food and Drug Administration under the Food Safety Modernization Act (FSMA).
- Understand US FDA FSMA Law for the Sanitary Transportation of Human and Animal Foods
- Understand changes from the proposed FDA FSMA rules
- Know the different requirements for shippers, carriers and receivers
- Know who is exempted
- Understand the FDA waiver requirements
Course 2: Awareness of Potential Food Safety Problems That May Occur During Transportation
This session covers bacteria, chemical and physical hazards, preventive control of hazards that can impact food during food load, unload and transportation operations; prevention versus corrective action, misuse of disinfectants and sanitizers, not cleaning bins, trays, pallets and other tools and equipment used in carrier operations, cross contamination, employee personnel hygiene, temperature variation; vehicle, container and trailer traceability and reporting systems, reefer failures, lack of container maintenance, improper or missing container security systems, accidents, recalls
- Understand basic bacterial, chemical and physical hazards
- Know what prevention means
- Know how tools and equipment, pallets, trays, bins, gaskets, hoses, load and unload systems, vehicles, containers and trailers can contaminate foods
- Understand the impact of temperature variation on food safety and food quality
- Know what conditions occur in transportation operations that may cause bacterial growth
- Be able to prevent cross contamination
- Know what missing records can mean
- Know what action to take if a reefer fails or a container is out of acceptable maintenance condition
- Understand accident protocols
- Be able to participate in recalls
Course 3: Basic Sanitary Transportation Practices to Address Food Transportation Sanitation Problems
Course includes contracts of carriage and agreements; system assessment strategy; flowcharting your operations, establishing critical parameters and measurement; standards for management, validation of preventive controls, sanitation, temperature monitoring and container (vehicles, trailers and shipping containers), traceability and training; procedures, record keeping and retention; audit and certification, training, wash, ATP and bacteria testing, inspection and re-inspection requirements, calibration, MSDS, statistical analysis and records retention.
- Develop a contract of carriage and other agreements required between carriers and shippers
- Understand basic management, preventive control, sanitation, temperature monitoring and traceability and training standards
- Help to write and implement appropriate container procedures (truck, trailer, sanitation, testing, container traceability and temperature monitoring)
- Learn to keep appropriate records
- Understand the transportation food safety audit and certification process
- Help to establish preventive controls
- Understand how to collect, analyze and take preventive action using statistical data