Written by Paul J. Kozacky
On Feb. 5, the Food and Drug Administration published a long‐anticipated proposed rule containing sanitary transportation practice criteria for shippers, receivers and carriers which transport food in the United States by motor vehicle or rail, whether or not the food is offered for or enters interstate commerce.
While a specific enforcement regime is not specified in the proposed rule, the FDA anticipates that the rule’s requirements will detail new standards that will assist in determining whether or not food should be considered adulterated for purposes of determining liability under the Federal Food, Drug and Cosmetic Act, 21 U.S.C. Section 331(hh).
This is the seventh and last rule proposed by the FDA to implement the FDA Food Safety
Modernization Act of 2011 (FSMA), which was signed into law on Jan. 4, 2011, to better protect human and animal health by helping ensure the safety and security of the food and feed supply.
This proposed rule is significant not only because it expressly applies to intrastate transportation but because it is the first time the FDA has imposed regulations directly on carriers. (For those interested in the federalism issue this presents, compare U.S. v. Regenerative Sciences LLC, 2014 WL 393602, No. 12‐5254 (D.C. Cir. Feb. 4, 2014) (FDA may regulate certain intrastate activity), with 21 U.S.C. Section 331(a) (prohibiting only the “introduction or delivery for introduction into interstate commerce of any food”).)
While carriers typically already are contractually bound to adhere to safety standards specified by their shippers, carriers and shippers both should be cognizant of the new record keeping, information‐exchange and training requirements imposed by the rule and the challenges these could present.
As it stands, the proposed rule would require carriers to:
- Demonstrate to shippers and, upon request, to consignees, that they have maintained appropriate temperature conditions during the transportation.
- Provide information to shippers about previous cargo transportation in bulk and the most recent cleaning of those vehicles, unless otherwise agreed to in writing that other procedures would be adequate for the bulk transportation at issue.
- Develop and implement written procedures subject to record keeping that describe how carriers will provide information to shippers regarding the previous cargoes and most recent cleaning of the vehicle, describe how they will maintain the requisite temperature
conditions and specify their practices for cleaning, sanitizing and inspecting vehicles and equipment. - Train personnel engaged in transportation operations in sanitary transportation practices and maintain records documenting the training.
In addition to the regulations, it would impose for the first time on carriers, the proposed rule would require shippers to:
- Specify to carriers in writing the sanitary requirements for a vehicle or transportation equipment to be provided for all food subject to the proposed rule and the temperature requirements for foods subject to temperature control requirements.
- Maintain records that demonstrate that shippers provide this information to carriers.
- Inspect a vehicle for cleanliness prior to loading food that is not completely enclosed by its own containers onto the vehicle.
A complete copy of the proposed rule can be seen at federalregister.gov/articles/2014/02
/05/2014‐02188/sanitary‐transportation‐of‐human‐and‐animal‐food#h‐28.
There are exemptions to the proposed rule. For example, the proposed rule would not apply to shippers, consignees or carriers who transport food but have less than $500,000 in total annual sales nor would it apply to the transportation of fully packaged shelf‐stable foods, live food animals and raw agricultural commodities transported by farms.
According to the FDA, while there is a significant number of players that have less than $500,000 in total annual sales, the rationale for their exemption is that these firms only account for 3 percent of insanitary transportation incidents.
The proposed rule will become effective 60 days after the final rule is published in the Federal Register, and compliance therewith will be required one year following that publication.
The FDA currently is required to publish the final rule by March 31, 2016. Businesses other than motor carriers who are also not shippers and/or consignees having less than $25.5 million in annual receipts and employing fewer than 500 persons would have an additional year to comply with the proposed rule.
The proposed rule is likely to have a significant impact on the cost of doing business in an industry that, until now, was not highly regulated by the FDA. The FDA estimates that the rule will cover 83,609 businesses and that total first‐year costs to industry will be $149.1 million (with an average of $1,784 per business) with total annual cost at $30.08 million (with an average of $360 per business).
The proposed rule is currently in the “public comment” period and the FDA may consider revising the rule based on input from the public. Such comments are due by May 31.
As a result, the FDA especially encourages written comments from carriers, suggesting that they would be receptive to data submitted by the transportation industry related to the cost of adhering to and the effectiveness of the proposed rule.
Comments may be submitted by interested persons and entities online at
http://regulations.gov/#!submitComment;D=FDA‐2013‐N‐0013‐0001.