On January 31, 2014, FDA issued a proposed rule on sanitary transportation of human and animal foods — the seventh of seven regulations mandated by the FDA Food Safety Modernization Act. So we now have all the proposed rules that would implement key elements of FSMA.
The other six rules deal with preventive controls for human food, preventive controls for animal food, produce safety, a Foreign Supplier Verification Program, accreditation of third-party auditors, and the prevention of intentional adulteration.
I view this transportation proposal as a valuable and necessary component of the collection of new rules that will introduce a more preventive approach to food safety in the United States. But there is a possible downside to introducing so many regulations at one time – especially for companies that find themselves suddenly required to understand and comply with several new sets of requirements under separate regulations. Animal feed companies, for example, may be unclear about their status relative to all of the FSMA rules. For example, if farmers have their own mills, does the exemption for feeding your own animals also apply to farmers who may feed their own animals that are housed in facilities owned by contract growers?
The sanitary transportation rule deals with requirements for proper refrigeration of food, the cleaning of vehicles between shipments, and the protection of food during transportation. As mandated by the lawmakers who crafted FSMA, the proposed rule would establish requirements for vehicles and transportation equipment and operations, as well as for training, records and procedures for waivers.
With certain exceptions, the proposed rule would apply to shippers, receivers, and carriers who transport food in the United States by motor or rail vehicle, whether or not the food enters interstate commerce. It would also apply to a person outside of the United States, such as an exporter, who ships food to the United States in an international freight container if it will be consumed or distributed in the United States.
I was interested to see what is not covered by the new requirements. For example, transportation of raw agricultural commodities performed by a farm is exempt. Also exempted are shippers, receivers, or carriers engaged in food transportation operations that have less than $500,000 in total annual sales. Food that is transshipped and not meant for consumption in the United States is also exempt. In addition, shelf-stable foods, compressed food gases and live food animals are exempt.
According to FDA’s estimates the proposed sanitary transportation rule will impact 83,609 businesses and the average cost is estimated at $1,784 per business in the first year, for a total of $149.1 million. The ongoing annual cost to the regulated companies is estimated at over $30 million.
The agency has scheduled three public meetings on the proposed rule, Feb. 27 in Chicago, IL, March 13 in Anaheim, Calif., and March 20 in College Park, MD.
The deadline for public comments is May 31, 2014.
Posted in Foods, FSMA Perspective and tagged Stephen Sundlof.