FDA proposes FSMA sanitary transportation rule

Published on: Jan 31, 2014

The Food and Drug Administration released its last major installment of the Food Safety and Modernization Act (FSMA) rules Friday with the release of the Proposed Rule on Sanitary Transportation of Human and Animal Food that would require certain shippers, receivers, and carriers who transport food by motor or rail vehicles to take steps to prevent the contamination of human and animal food during transportation.

The pre-publication of the seventh FMSA proposed rule is set to be published in the Federal Register on Tuesday, Feb. 4. Comments are due on the rule by May 31, 2014.

FDA reported in a fact sheet summary that this proposed rule is estimated to cover 83,609 businesses. This number includes carriers engaged in food transportation and facilities that ship food subject to this proposed rule. The total first-year cost is estimated to be $149.1 million (with an average of $1,784 per business), and the total annual cost is estimated to be $30.08 million (with an average of $360 per business).

Specifically the proposed rule would establish requirements for vehicles and transportation equipment in the design and maintenance of vehicles and transportation equipment to ensure that it does not cause the food that it transports to become contaminated. The rule also proposes requirements on measures taken during transportation to ensure food is not contaminated, such as adequate temperature controls and separation of food from non-food items in the same load.

It also establishes procedures for exchange of information about prior cargos, cleaning of transportation equipment, and temperature control between the shipper, carrier, and receiver, as appropriate to the situation. For example, a carrier transporting bulk liquid non-dairy foods would want to ensure that vehicles that have previously hauled milk will not introduce allergens into non-dairy foods through cross contact.

The rule also establishes requirements for training and maintenance of records. The rule also provides procedures by which the FDA will waive any of these requirements if it determines that the waiver will not result in the transportation of food under conditions that would be unsafe for human or animal health and that it is in the public interest.

Richard Sellers, senior vice president of legislative and regulatory affairs at the American Feed Industry Assn., said AFIA will review the proposed rule and will comment accordingly with the May 31 deadline.

“AFIA will continue to work cohesively with FDA during the rulemaking process to ensure the transportation rule as well as the other FSMA rules pertaining to the feed industry address the concerns of the industry,” he said.