FDA Releases Proposed Sanitary Food Transportation RegulationsFebruary 9, 2014
By Riëtte van Laack –
FDA published a proposed rule to implement the Sanitary Food Transportation Act of 2005 (“SFTA”) in the Federal Register on February 5. FDA also published Questions and Answers related to the sanitary transportation of human and animal food. Enacted in 2005, the SFTA shifted responsibility for safe transportation of food from the U.S. Department of Transportation (“DOT”) to FDA. The SFTA created new sections of the FDC Act providing that failure to comply with the sanitary food transportation regulations renders the transported food adulterated and is a prohibited act. It further added section 416, which requires FDA to develop regulations addressing sanitation, packaging, limits on transport vehicles, information exchange among carriers, manufacturers and other persons involved in transportation of food, and transportation-related record keeping. Five years later, in April 2010, FDA issued both an advance notice of proposed rulemaking and a guidance addressing transportation of food. Apparently unhappy with FDA’s progress in SFT rulemaking, Congress in FSMA directed FDA to issue SFT regulations by a specific date. Although FDA failed to meet that deadline, it did meet a court deadline imposed pursuant to litigation regarding FDA’s failure to meet FSMA’s deadlines.
The proposed rule applies to food shippers, carriers and receivers, “whether or not the food is offered for or enters interstate commerce.” For purposes of the SFTA food includes human food, dietary supplements, animal food, raw materials, and ingredients (including packaging), and food subject to the Federal Meat Inspection Act, the Poultry Products Inspection Act, and the Egg Products Inspection Act.
FDA's proposed regulation would not apply to:
- Transportation of shelf-stable food that is completely enclosed by a container.
- Transportation of raw agricultural commodities that is performed by a farm (“farm” is defined in the SFT regulations).
- Transportation of compressed food gases.
- Transportation of live food animals.
The regulation would affect shippers (a person who initiates a shipment of food by motor or rail vehicle), carriers (the persons who owns, leases, or otherwise are ultimately responsible for the use of a motor or rail vehicle to transport food), and receivers (persons who receive food after transportation, whether or not they represent the final point of receipt for the food) that are engaged in “transportation operations” for food. It establishes requirements for:
- Vehicles and transportation equipment
- Transportation operations
- Information exchange
Shippers, carriers, and receivers must employ effective measures to protect food during transportation. For example, shippers must inform their carriers about the requirements for the transported products, such as temperature control, and verify cleanliness of the transportation equipment before shipment. Carriers will have to supply vehicles that meet the shipper’s requirements, implement procedures to govern their SFT activities, and train employees.
Under the FDC Act, FDA has the authority to waive any of the SFT requirements “with respect to any class of persons, vehicles, food, or nonfood products” for which the Agency determines that a waiver will not (1) result in transportation of food under unsafe conditions and (2) be contrary to the public interest.
The proposed regulation includes a process by which a party may request a waiver. In addition, FDA has tentatively determined that it is appropriate to waive the SFT requirements for:
- Shippers, carriers, and receivers who hold valid permits and are inspected under the NCIMS Grade “A” Milk Safety Program, only when engaged in transportation operations involving Grade A milk and milk products.
- Food establishments (as defined in the Food Code) holding valid permits, only when 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.
To what extent these regulations will have a noticeable effect on safety of food remains to be seen. In Questions and Answers regarding the proposed regulations, FDA acknowledges that the risk of contamination from transportation is low. Moreover, the Agency indicates that although it has funding to issue the rule, it will need additional funding to fully implement the rule. For enforcement, the Agency will depend on assistance from the DOT and state personnel.
Comments may be submitted until May 31, 2014. In part, FDA requests comments on:
- whether the provisions should be applicable to activities that are intrastate in character;
- FDA’s tentative conclusion that shelf stable food that is completely enclosed by a container, compressed food gases, and live food animals should be excluded from the scope of the proposed rule;
- the proposed waivers.