New FDA Shipping Rule to Help Cut Food Allergen Recalls

in Food Allergy, Recalls
Published: August 29, 2016
Stalk of Wheat with Silo in BackgroundPhoto: Thinkstock

A long-awaited federal rule aimed at boosting safety procedures for the transport of food could help to reduce the number of allergy-related recalls and protect consumers from unwitting exposure to top allergens.

The new Sanitary Transportation of Human and Animal Food rule, which falls under the U.S. Food and Drug Administration (FDA) Food Safety Modernization Act, sets out requirements for the sanitary bulk transportation of food by road and rail.

The rule, which took effect in June 2016, specifically mentions cross-contact as the “unintentional incorporation of a food allergen.” For example, cross-contact would result if the residue of a major allergen was left behind in a shipping vehicle and got into the food supply. Large food producers must be in compliance no later than April 6, 2017, while smaller producers have an additional year to do so.

Until now, the granting of authority by Congress to the FDA to specifically regulate carriers – truck and rail car operators – was missing, said Michael Kashtock of the FDA Office of Food Safety, who oversaw the development of the rule. “It’s a new authority that the FDA has, which is really appropriate considering that there are potential risks involving bulk transport that in the past the FDA wasn’t as effectively able to address,” he told Allergic Living.

The rule outlines such measures as segregation and handwashing to protect food transported in bulk vehicles or not completely enclosed in a container. It also details responsibilities of shippers and carriers. As defined by the rule, a shipper arranges to have food transported with a trucking or rail company and a carrier physically moves the food.

Shippers must now develop procedures to ensure that a previous cargo does not make food unsafe. They are obliged to keep records and address proactively the possibility that a truck or railcar may have previously hauled something that could introduce an allergen.

Carriers will also need to keep records so that information can be provided to the shipper upon request identifying the previous cargo and indicating the time the vehicle was last cleaned. Kashtock says the FDA can inspect the records to verify compliance. If the FDA determines that safety rules are not being properly followed, food can be seized, and if willful non-compliance is detected, violators can face penalties under criminal statutes.

“The way these rules work, you don’t have the luxury of putting food on the market if you’ve cut corners and not complied with the requirements of the rule,” Kashtock said, adding that failure to comply can lead to the use of stiff enforcement measures.

The rule may help to prevent mass recalls, such as one that occurred recently when leading food manufacturers had to withdraw hundreds of snack products – because the flour they were made from contained low levels of undeclared peanut.

The unintended cross-contact caused widespread concern in the food allergy community, and the exact source of the peanut remains unclear. Wholesale flour supplier Grain Craft stated, however, that the peanut exposure could not have happened at its South Georgia mill, where the affected soft red winter wheat flour was produced.

The recalls saga began in April 2016 and unfolded over 2½ months. In June 2016, after two children suffered allergic reactions from eating its donuts, Hostess recalled 710,000 cases of donut and snack cakes. Soon, other major manufacturers, including Frito-Lay, Kellogg’s, Mars and Mondelez, withdrew products.

Based on interviews with food science and agricultural experts, Allergic Living learned the most likely scenario is that cross-contact could have occurred during transportation. However, exactly how that would have happened may never be established, and the FDA is still investigating.

The new sanitary food transportation rule does not set specific guidance to prevent food cross-contact on farms. However, if a farmer is moving food in an unsafe manner, the FDA still has the authority to act under general law.

It could be that at some point in the future we may expand guidance and rulemaking to cover farm transport, Kashtock said. “It was a matter, at this point, of trying to utilize the resources we had to cover what we considered the predominant part of the transportation system.”