Mr. Acheson said the food industry should turn its attention to three imminent F.D.A. actions related to the F.D.A. Food Safety Modernization Act, including the pending release of a proposed rule on sanitary transportation of food, an accelerating pace in developing a final rule for preventive controls for human food and produce, and the agency’s gathering and studying of industry comments in connection with the recently released proposed rule on preventing intentional adulteration of food.
In a discussion with Food Business News, Mr. Acheson indicated F.D.A.’s proposed rule on sanitary transportation of food was being studied by the Office of Management and Budget before its publication.
“I have heard they (the F.D.A.) are targeting to get it out in the next month or two, but you just never know,” he said.
The F.D.A. was under pressure to publish the proposed rule by the end of this month. The U.S. District Court for the Northern District of California last August extended the deadline for the proposed sanitary transport rule by 60 days, to Jan. 31, 2014, from Nov. 30, 2013. The comment period on the proposed rule was delayed 60 days as well and was required to conclude on May 31, 2014. The deadline for publication of the final rule is June 30, 2015.
Under the Food Safety Transportation Act of 2005, the F.D.A. was given the responsibility to promulgate regulations setting forth sanitary transportation practices to be followed by shippers, carriers by motor vehicle or rail vehicle, receivers and others involved in food transport to ensure food is not transported under conditions that may render the food adulterated.
The F.D.A. over the years addressed the transportation of food in several regulations and guidance documents, but each of the regulations and guidance documents was limited in scope to a particular circumstance, the agency acknowledged. There was no overall rule establishing and defining regulations that must be followed by all parties engaged in transport of food.
In guidance to industry on the sanitary transportation of food issued by the F.D.A. in April 2010, the agency said the industry should be aware of problem areas where food may be at risk for physical, chemical or biological contamination during transportation. It enumerated several problem areas and recommended professionals engaged in the transportation of food concentrate their efforts on the following, broadly applicable preventive controls:
• Appropriate temperature control during transport.
• Sanitation, including monitoring and ensuring the sanitation and condition of transportation vehicles as appropriate; pest control, and sanitation associated with loading and unloading procedures.
• Appropriate packaging/packing of food products and transportation units (for example, good quality pallets, correct use of packing materials).
• Good communication between shipper, transporter and receiver.
• Employee awareness and training.
Mr. Acheson affirmed there was a qualitative difference between the 2010 guidance and the proposed rule that may be summed simply as guidance provides recommendations whereas as “a rule is a rule.” He added, “I think the proposed rule will focus on risks that are controlled by transporters such as temperature, sanitation and cross contamination. I don’t imagine it will differ significantly in content from prior guidance.”
While the 2005 act gave the F.D.A. authority to promulgate overall regulations on the safe transportation of food, it largely failed to do so, partly because of its need to address what were perceived to be more pressing issues, Mr. Acheson said. When Congress included the requirement in the F.S.M.A. for a final rule on the sanitary transport of food, it was its way of “holding F.D.A.’s feet to the fire to make it happen.”
He said the proposed rule will be an essential element in realizing the promise of the F.S.M.A.
“The sanitary transport for food is important and often neglected,” he said. “Food may spend a significant amount of time in transport, time that may allow bacteria to grow if the temperatures are not controlled. Similarly, back-hauling fresh produce in a truck used to carry raw poultry is not that uncommon, and it, too, can generate risk that has to be controlled. Some states a while ago started to focus on this and found a lot of problems. Many of these issues are seen in local vans and trucks and not just in the long haul.”
Mr. Acheson said the proposed rule may “put trucking companies in a tailspin. They currently do the minimum, and this could really shake them up and have them looking for solutions around reducing food safety risk.” He added transport companies should intensify effort to control risks and be prepared to document those controls.
Turning to the matter of preventive controls for human food and produce, Mr. Acheson said, “I predict that F.D.A. will be scrambling to get through the comments so that it can draft another round and get that out for further comments before taking the rule to final in 2015. However, we would expect a very short comment period — of perhaps 60 days — on the revised proposal. In the next version, we also expect to see supplier controls and environmental monitoring, and possibly finished product testing for high-risk foods.”
With regard to the recently issued proposed rule on controls to prevent intentional adulteration, Mr. Acheson said, “With the new proposed F.S.M.A. rule on food defense requiring training, we would expect to see a lot of new ‘expert’ offerings in this area. We would thus caution the industry to ensure that any such trainers with whom they contract truly are experts in the area. As with the previous proposed rules, F.D.A. is seeking a great deal of comment, and we would expect that industry and industry associations will have a great deal of interesting comments for F.D.A.”