FDA finalises FSMA rule for food safety during transport

It will require those involved in transporting human and animal food by motor or rail to follow best practices for sanitary transportation, such as properly refrigerating food, adequately cleaning vehicles between loads and properly protecting food during transportation.

The Food Safety Modernization Act (FSMA) rule on Sanitary Transportation of Human and Animal Food​ is one of seven rules proposed since January 2013, six have been finalized with the final one expected later this year.

The rule implements the Sanitary Food Transportation Act of 2005 (SFTA) and the requirement in section 111 of FSMA that instructed FDA to issue SFTA regulations.

In response to comments, the rule was changed to focus on practices that create safety risks, rather than those that affect quality but don’t necessarily make it dangerous to consume.

Who is and is not covered?​

The regulation will apply to food transported within the US by motor or rail vehicle, whether or not food is offered for or interstate commerce.

Shippers, loaders, carriers and receivers in transportation operations of food imported by motor or rail and consumed or distributed in the US are also subject to the final rule.

Companies transporting food for export are covered by the rule until the shipment reaches a port or US border.

It does not affect exporters who ship food through the US (for example, from Canada to Mexico) by motor or rail vehicle if the food does not enter US distribution.

A webinar is planned for April 25 to present the final rule and FDA will develop an online course.

The rule was proposed in February 2014 and takes into consideration more than 200 comments​ from the transportation and food industry, government regulatory and international trading partners, consumer advocates, tribal organizations and others.

The Grocery Manufacturers Association (GMA), International Bottled Water Association (IBWA), Food Marketing Institute (FMI), The Pew Charitable Trusts, Chiquita Brands International, Juice Products Association and The Society of the Plastics Industry were among the commenters.  

It also builds on the transportation industry’s best practices for cleaning, inspecting, maintaining, loading and unloading and operating vehicles and transportation equipment.

One change was from a requirement to use a temperature indicating or recording device during transport for foods that require temperature control for safety to a more flexible approach and carriers needing to demonstrate they maintained temperature conditions only upon request, rather than for every shipment.

“Consumers deserve a safe food supply and this final rule will help to ensure that all those involved in the farm-to-fork continuum are doing their part to ensure that the food products that arrive in our grocery stores are safe to eat​,” said Michael Taylor, the FDA’s deputy commissioner for foods and veterinary medicine.

Compliance dates and waivers​

Businesses are required to comply one year after publication of the final rule in the Federal Register with smaller businesses having two years.

A smaller business is those other than motor carriers who are not also shippers and/or receivers employing fewer than 500 people and motor carriers having less than $27.5m in annual receipts.

The FDA is reviewing comments ahead of a decision on a waiver for transportation operations of molluscan shellfish for entities that hold valid state permits under the National Shellfish Sanitation Program.

It intends to publish conditional waivers for shippers, carriers and receivers who hold valid permits and are inspected under the National Conference on Interstate Milk Shipments (NCIMS) Grade “A” Milk Safety program and food establishments holding permits from a relevant regulatory authority when acting as receivers, shippers and carriers in operations in which food is relinquished to customers after being transported from the establishment such as restaurants and supermarkets.

The final rule builds on the preventive controls rules for human food and animal food, the Produce Safety rule, Foreign Supplier Verification program rule and the Accreditation of Third-Party Certification rule, all of which FDA finalized last year.

The seventh rule, which focuses on mitigation strategies to protect food against intentional adulteration, is expected to be finalized later this year.