FDA’s New Sanitary Transportation Regulations Focus on Safety

By Riëtte van Laack –

Last week, FDA issued the sixth of the seven major rules expected to issue under the authority of the Food Safety Modernization Act (FSMA), namely the final rule for Sanitary Transportation of Human and Animal Food. Although FSMA directed FDA to issue this rule, the rule implements the Sanitary Food Transportation Act of 2005 (SFTA). FDA issued its proposed rule in 2014 (see our previous post here).

FDA received about 240 comments and the final rule is almost 80 pages long. A fact sheet of 4 pages provides a handy summary of the key requirements.

The SFTA expressly mandates that FDA issue regulations to require “shippers, carriers by motor vehicle or rail vehicle, receivers, and other [parties] to use sanitary transportation practices to ensure that food is . . . transported” so that is does not become adulterated. Because the law specifically calls out transport by motor and rail vehicles, the regulations apply only to those means of transport and do not extend to transport by water or air.

The final rule is quite different from the proposed rule. Notably, it provides more flexibility for parties involved and exempts various parties that, under the proposed rule, would have been subject to the regulations.

Importantly, FDA shifted its focus to prevention of unsafe food and the regulations no longer are concerned with spoilage of food. Other important changes include changes in definitions of carrier (the person who physically moves food), shipper (the person who arranges for the transportation of food), and receiver (the person who received food at a point in the United States) after transportation. In addition, FDA added the definition for “loader,” i.e., a person that loads food onto a motor or rail vehicle during transportation operations. The definitions are not exclusive, such that a party may be the shipper, the carrier, and receiver. The redefined terms leave less uncertainty about who has the responsibility for what. Under the final rule, the shipper has the primary responsibility for the determination of requirements and developing and implementing written procedures for sanitary transportation. The shipper may assign some of the responsibilities to other parties such as the carrier or loader by written contract (provided they agree to accept that responsibility).

Training requirements under the regulations are limited to training requirements for carriers that accept, pursuant to a written agreement with the shipper, responsibility for the sanitary conditions during the transportation operation. Absent such agreement, the carrier is not subject to training requirements. The rule does not include requirements for training of the shipper, loader, and receivers because, according to FDA, training for these parties is addressed in the cGMP regulations for entities that would operate as shippers, receivers and loaders.

The final rule is less prescriptive than the proposed rule and clarifies that the controls required depend on the type of food and the production stage of the product transported. Moreover, it does not require the use of a temperature recording device but leaves it up to the shipper and carrier to determine what temperature monitoring mechanism is sufficient for foods that require temperature control for safety.

The final rule includes broader exemptions than the proposed rule, such as

• Transport of food completely enclosed by a container (except food that requires temperature control for safety)
• All transportation activities by a farm

Also, there is a new exemption for human food byproducts transported for use as animal food without further processing, which is somewhat curious since animal food transported for use as animal food is not exempt.

In response to comments, FDA stresses that the rule is intended to be complimentary to the preventive control regulations for human and animal food and establishes detailed requirements for shippers, loaders (a newly defined category), receivers and carriers to use sanitary transportation practices to prevent that the food becomes unsafe during transport. Parties that are exempt from the regulation may still be subject to the transportation-related requirements in the good manufacturing practice regulations. Moreover, in any case, the general adulteration provisions of the FDC Act apply.

The compliance date is April 6, 2017 for all businesses except for small businesses, which have until April 6, 2018 to comply. FDA asserts that “[s]ince the rule has its basis in industry practices, many persons should [already] be in substantial compliance with its provisions and should not find compliance burdensome.” FDA plans to issue guidance for industry. In addition, FDA also plans to develop, before the first compliance date, an online course that would meet the training requirements for this rule.

FDA has not yet published the waivers announced in the proposed rule. Presumably these will be published before the first compliance date. A request for a waiver for transportation of molluscan shellfish is under review.