FDA Tells Shippers to Keep It Clean (When It Comes to Food)

3 min

On April 6, 2016, the U.S. Food and Drug Administration (FDA) issued a final rule intended to protect the safety of food—both human and animal—during transport. The final rule can be read in the Federal Register here.

The final rule establishes requirements for shippers, loaders, carriers, and receivers engaged in the domestic transportation of food by truck or rail to use sanitary transportation practices to ensure the safety of transported foods. Importantly, the requirements do not apply to transportation of food by air or ocean/inland waterway. Companies will be required to comply with the new requirements as of April 6, 2017. Small businesses, however, do not need to comply until April 6, 2018.

Key requirements of the law include:

  • Vehicles and Transportation Equipment. The final rule imposes requirements on the design and maintenance of vehicles and other equipment aimed at avoiding contamination of food—for example, ensuring transport equipment is easily cleanable or can maintain an appropriate temperature.
  • Transportation Operations. This involves measures aimed at ensuring food safety during transportation, such as temperature controls and protecting food from cross-contamination.
  • Training. The final rule requires training of rail and motor carrier personnel in sanitary transportation practices. This training is required when the carrier and shipper agree that the carrier is responsible for sanitary conditions during transport.
  • Records. Maintenance of records of written procedures, agreements and training is required under the final rule. While the required retention period varies based on specific factors, it does not exceed 12 months.
  • Waivers. At this time, the FDA plans to publish waivers for (i) those who hold valid permits and are inspected under the National Conference on Interstate Milk Shipments (NCIMS) Grade "A" Milk Safety program, and (ii) food establishments holding valid permits issued by a relevant regulatory authority, such as a state or tribal agency, when engaged in operations in which food is relinquished to customers after being transported from the establishment.

As noted, small businesses have two years to comply with the new requirements (i.e., until April 6, 2018). Small businesses are defined as businesses other than motor carriers, that are not also shippers and/or receivers and employ fewer than 500 persons, and motor carriers having annual receipts of less than $27.5 million. All other businesses have one year to comply (i.e., until April 6, 2017) unless a below exemption applies.

Finally, the FDA carves out eight categories that are exempt from this rule. These include:

  • Shippers, receivers, or carriers engaged in food transportation operations that have less than $500,000 in average annual revenue;
  • Transportation activities performed by a farm;
  • Transportation of food that is transshipped through the United States to another country;
  • Transportation of food that is imported for future export and that is neither consumed or distributed in the United States;
  • Transportation of compressed food gases and food contact substances;
  • Transportation of human food by-products transported for use as animal food without further processing;
  • Transportation of food that is completely enclosed by a container, except a food that requires temperature control for safety; and
  • Transportation of live food animals, except molluscan shellfish.

If you have any questions or would like to discuss the specific implications of or how to comply with this final rule, please contact one of the listed authors.