THE Food & Drug Administration released the last major installment of its Food Safety Modernization Act (FSMA) rules Jan. 31 when it issued 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 seventh FSMA proposed rule was published in the Federal Register on Feb. 4. Comments on the rule are due by May 31.
FDA reported in a fact sheet summary that the proposed rule is estimated to cover 83,609 businesses. This number includes carriers engaged in food transportation and facilities that ship food subject to the rule.
The total first-year cost is estimated to be $149.1 million (an average of $1,784 per business), and the total annual cost is estimated to be $30.08 million (an average of $360 per business).
Specifically, the proposed rule would establish requirements for the design and maintenance of vehicles and transportation equipment to ensure that they do not cause the food they are transporting to become contaminated.
The rule also proposes requirements on measures taken during transportation to ensure that food is not contaminated, such as having adequate temperature controls and separating food from non-food items in the same load.
It further establishes procedures for the shipper, carrier and receiver to exchange information about prior cargoes, cleaning of transportation equipment and temperature control, as appropriate to the situation. For example, a carrier transporting bulk liquid non-dairy foods would want to ensure that vehicles that previously hauled milk will not introduce allergens into non-dairy foods through cross-contact.
The rule establishes requirements for training and for maintaining records.
The rule also provides procedures by which 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 is in the public interest.
Richard Sellers, senior vice president of legislative and regulatory affairs at the American Feed Industry Assn. (AFIA), said AFIA will review the proposed rule and will comment accordingly by the May 31 deadline.
"AFIA will continue to work cohesively with FDA during the rule-making 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.
The notice exempts or excludes coverage for: transportation activities for raw agricultural commodities performed by a farm, the transportation of live food animals and shippers, receivers or carriers engaged in food transportation operations that have less than $500,000 in total annual sales.
FDA plans to hold three public meetings on the rule: Feb. 27 in Chicago, Ill.; March 13 in Anaheim, Cal., and March 20 in College Park, Md.