3 Waivers to FSMA Transportation Rule

Following on a promise made when the Sanitary Transportation of Human and Animal Food rule was initially proposed, the FDA announced during the first week of April that it would waive the rule in instances where the federal agency was satisfied further regulation would be redundant and therefore unnecessary.

As part of the FDA Food Safety Modernization Act (FSMA), the FDA published three waivers earlier this month to the Sanitary Transportation rule, applicable to businesses engaged in transportation that is also subject to state-federal oversight.

The businesses to which the waivers pertained were:

1. Those holding permits of inspection under the National Conference on Interstate Milk Shipments’ Grade-A Milk Safety Program (applicable only to the transport of Grade-A milk and milk products);

2. Food establishments, such as restaurants, supermarkets, and grocery delivery services authorized to operate as receivers, shippers, and carriers in operations that deliver food directly to consumers, or to other establishments that sell food directly to consumers; and

3. Businesses transporting shellfish of the molluscan variety (including oysters, clams, mussels, and scallops) already certified and inspected in accordance with the Interstate Shellfish Sanitation Conference’s (ISSC) National Shellfish Sanitation Program—this is providing that the shellfish are transported only in vehicles permitted under ISSC authority.

The waivers are not impressive to John Ryan, president of TransCert and the Sanitary Cold Chain. “While the rule harps on ‘prevention,’” Ryan says, “there are no preventive controls applied nor is there any mention of ‘validation.’  In short, the rules leave the food safety door open in many ways and as of today, most carriers and shippers are either unaware of the new rules of don’t seem to care about FDA deadlines.”

Randall Fields, chairman and CEO of ReposiTrak and Park City Group, is more positive in his response, noting that “The Sanitary Transportation rule under FSMA is squarely focused on establishing sanitary practices to ensure no food is adulterated in transit. So much of FSMA is centered on the production of food, but it’s just as important to protect it from risk during transport and storage. The risks addressed under this rule include refrigerating temperatures for sensitive foods, cleaning vehicles between loads, and making sure foods are not contaminated during transit.”

Fields puts his trust in the FDA, saying that the waivers had been expected for some time, since the FDA promised it would waive restaurants, grocery stores, and milk-transporters—whose transportation operations are already subject to compliance with separate state-federal controls.

“So these waivers were not a surprise,” Fields says. “The FDA considered comments on the waivers and found that they would not result in the transportation of food under conditions that would be unsafe for human or animal health, or contrary to the public interest.”

There is nothing to be gained, Fields underlines, from regulatory redundancy when one set of regulations is all that’s necessary to accomplish a goal.

“It’s fortunate the FDA is not overlapping in areas where sufficient regulation already exists,” Fields concludes. “Given the constraints of FSMA funding, there are certainly plenty of other areas where the FDA can target mandating compliance.”