FDA Proposes Final FSMA Rule Focusing on Transportation

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FDA Proposes Final FSMA Rule Focusing on Transportation


By Meg Major

The U.S. Food and Drug Administration unveiled the final major pillar of the Food Safety Modernization Act (FSMA) that would help prevent the contamination of food products during transportation by establishing requirements for sanitary transportation practices.

The proposed rule, which is open for public comment through May 31, 2014, is the seventh step to advance FSMA, which went into effect in January 2011 and which marks the most sweeping food safety legislation to occur in the last 70 years.

“This proposed rule will help reduce the likelihood of conditions during transportation that can lead to human or animal illness or injury,” said Michael R. Taylor, the FDA’s deputy commissioner for foods and veterinary medicine. “We are now one step closer to fully implementing the comprehensive regulatory framework for prevention that will strengthen the FDA’s inspection and compliance tools, modernize oversight of the nation’s food safety system, and prevent foodborne illnesses before they happen.”

In a related blog post, Taylor said FSMA “is making it possible for [FDA] to reinvent ourselves, becoming a force for the prevention of foodborne diseases rather than being mainly first-responders to food safety problems in progress."

And though Taylor said it’s fairly uncommon for a foodborne illness to be caused by contamination during transportation, “We have received reports of unsanitary practices, and we want to minimize this potential source of illness.”

Targeting Greatest Risks

The proposed regulation would establish criteria for sanitary transportation practices, such as properly refrigerating food, adequately cleaning vehicles between loads, and properly protecting food during transportation.

The proposed rule would apply to shippers, carriers and receivers who transport food that will be consumed or distributed in the United States and is intended to ensure that persons engaged in the transportation of food that is at the greatest risk for contamination during transportation follow appropriate sanitary transportation practices.

The latest proposal to the most comprehensive reform of the nation’s food safety laws in seven decades – which are predicated on shifting the focus from responding to food safety issues to prevention – was welcomed by industry trade groups, including the Grocery Manufacturers Association (GMA). Dr. Leon Bruner, GMA’s chief science officer, said the proposed rule “will place new and enhanced requirements on the transportation of food products between industry facilities that will further ensure the safety of the foods eaten by consumers from farm to table.

“GMA is proud of its work to support FSMA and the leadership role we’ve played on behalf of industry to educate food and beverage manufacturers on what it will take to comply with the law, not only in the U.S. but along the entire global supply chain,” added Bruner. “We are very pleased that implementation of FSMA is moving forward and look forward to working with the FDA by continuing to share our food safety expertise and best practices and by evaluating and commenting on this proposed rule.”

Functional Examples

In terms of how the final proposed rule will function, fresh produce shippers, for example, would be required to inspect a vehicle for cleanliness prior to loading food that is not completely enclosed by its container (i.e., fresh produce in vented boxes) onto the vehicle. The proposed rule would also apply to international shippers which transport food for U.S. consumption or distribution in an international freight container by air or by oceangoing vessel and arrange for the transfer of the intact container onto a motor vehicle or rail vehicle.

The proposed rule would not cover shippers, receivers or carriers engaged in food transportation operations that have less than $500,000 in total annual sales. In addition, the requirements in the proposed rule would not apply to the transportation of fully packaged shelf-stable foods, live food animals and raw agricultural commodities when transported by farms.

The requirements would also not apply to shippers, receivers or carriers who are engaged in transportation operations of food that is transshipped through the U.S. to another country, nor to food that is imported for future export and that is neither consumed nor distributed in the U.S.

The FDA is proposing staggered implementation dates for the proposed rule based on business size, ranging from one to two years after publication of the final rule. The agency will discuss the proposed rule at three upcoming public meetings: Feb. 27, 2014 in Chicago; March 13, 2014 in Anaheim, Calif.; and March 20, 2014 in College Park, Md.