The Food and Drug Administration’s (FDA) estimates of costs for a proposed rule (PR) governing the sanitary transportation of food are likely “grossly underestimated” while the benefits the proposal would yield are questionable.

That broadside is contained in formal comments  filed with the agency by the  American Trucking Assns. (ATA) and its affiliate, the Agricultural and Food Transporters Conference (AFTC).

In addition, ATA asked that FDA reopen or “re-propose” the rule to allow for comment on any significant changes that are made before the PR is finalized.

The trucking lobby noted that, along with its usual analysis process, it considered the results of a special survey of ATA members regarding food transportation before submitting its comments.

The projected first-year cost for the rule of $149.1 million will be significantly higher if the estimated 83,609 firms affected by it must change their recordkeeping procedures to the listed 12-month time frame given in FDA’s recently updated guidance for recordkeeping, ATA said.

“In addition to recordkeeping, the training requirements could potentially increase that cost especially given the industry’s driver turnover rate,” ATA told FDA.

ATA added that current training provides drivers what they need to know to properly transport food. But it argued that increasing or extending those requirements could substantially increase costs. “The time and effort those companies need to expend in order to understand and comply with this rule will also contribute to the initial startup cost,” commented ATA.

What’s more, the PR lacks benefits because existing regulations have “a proven track record in preventing the outbreak of food borne illness,” and the food transportation system in the United States “is the envy of the world,” ATA told FDA.

“In the PR’s executive summary it states that ‘the goal of the PR is to ensure that transportation practices do not create food safety risks,’” stated the association. “From feedback that FDA has received, and given the industry’s safety statistics, ATA believes ‘the goal’ is already being reached.”

Noting that the PR emphasizes carrier communication with both shipper and receiver, ATA observed that “this communication is common practice within the industry and has shown to work well in providing successful shipments from point A to point B.”

Aside from the big picture of costs and benefits, ATA recommended several specific changes to the PR:

  • Clarifying the definition of “shipper” to place responsibility on a single person or entity that initiates a movement of food in commerce.The term should not include logistics providers who merely arrange for transportation services, ATA said.
  • Excluding small-parcel common carriers from the definition of “carrier.” Aplying the definition to entities such as the United States Postal Service (USPS), United Parcel Service, and Federal Express would be costly, ATA told the agency, adding that an FDA official in one public meeting expressed skepticism that such carrier were intended to be included in the first place.
  • Providing some flexibility in the operating conditions under which food is transported. For example, ATA noted that temperatures in a refrigerated trailer may fluctuate due to the refrigeration unit turning on and off to reach a set temperature and could very briefly exceed the upper limit specific in a shipping contract without compromising the product.
  • Specifying that food temperature-controlled for quality does not fall under the same guidelines as food that is temperature controlled for safety. “The goal, as stated by FDA, is to ensure food is transported in a way that keeps it from becoming adulterated, not less fresh. The industry, and consumers, will dictate the freshness of a product.”
  • Giving receivers the flexibility to test products if there was an issue during transport and not force them to automatically decline loads that were outside certain parameters for a short period of time.  Holding everyone within a supply chain to strict, rigid standards within a contract could require treating perfectly good loads as adulterated, ATA said, adding that this is of great concern for carriers due to liability for cargo loss. “The practical reality is that cargo claims would likely increase dramatically, resulting in rejected loads due to harmless temperature fluctuations,” ATA said. “A single cargo claim on food products can exceed $100,000 per claim.” If the PR results in just one additional successful cargo claim for each firm, the costs will dramatically exceed those FDA estimates, ATA said.
  • Allowing flexibility on the proposed requirement for precooling of containers depending on best practices. Although precooling often a good practice, sometimes it is not necessary or even possible to precool prior to loading, ATA said. For example, carriers hauling frozen food use the product itself to cool the trailer during transport.
  • Reconsidering the proposed exemption for operations with less than $500,000 in total annual sales. FDA itself suggests that operations most likely to have adulterated food were those using smaller box trucks and making daily deliveries. “ATA wants to ensure that the final rule addresses those who have the greatest risk of causing food borne related illness, and not exempt them from the rule that would minimize that risk.

The Owner-Operator Independent Drivers Assn. went a step further in its comments by recommending-- for the reason cited by ATA– that FDA adopt rules focused on local-delivery box truck operations. It also argued that FDA should impose greater obligations upon the handling of food products before and after they are loaded onto or unloaded from a truck.

OOIDA’s comments also addressed the need for FDA to reconsider the waivers it has proposed and has not proposed. And it called on the agency to establish rules for safe disposal of contaminated foods.

Given that food transportation is dominated by small-business trucking, FDA should consider the impact of the PR on this segment in determining what is truly cost effective, OOIDA said.

“As discussed above, small-business truckers have been inundated with government regulations that have increased their costs to a level that already makes it difficult for them to remain in the industry,” OOIDA told FDA. “Overly-restrictive rules could simply push smaller carriers out of the business, making it difficult for those who grow, package, or otherwise process food products requiring special handling to get transportation services they need at reasonable prices.”

To view FDA’s proposal and other comments submitted, click here.