By March 31, 2016, FDA must publish final rules on the sanitary transportation of food by truck and rail. FDA’s deadline was imposed by a Consent Decree in February 2014, which comes twenty-five years after Congress first tried to ensure that garbage trucks are not also used to haul fresh produce. Initial comments on the proposed rule closed in July 2014.
If all goes according to plan, the final rule will see the light only after three successive pieces of legislation—the Sanitary Food Transportation Act of 1990, the 2005 Sanitary Food Transportation Act, and the Food Safety Modernization Act of 2010 (“FSMA”)—have mandated its promulgation. As proposed, however, the final regulation will give “businesses other than small businesses” just one year to comply. Improperly transported food will be deemed “adulterated” and banned from interstate commerce under the Federal Food, Drug and Cosmetic Act, and noncompliance could constitute a crime.
FDA’s proposed Rule on Sanitary Transportation of Human and Animal Food (“Rule”) is one of seven rules that are intended to realize FSMA’s goal of ensuring the safety and security of the nation’s food and feed supply. The Rule establishes criteria—including standards governing cleanliness, temperature control and allergen segregation—for the safe transportation of food by motor or rail vehicle. A shipper or carrier with less than $500,000 in total annual sales, food that is transshipped through the U.S. for consumption in another country, and the transportation of shelf-stable food that is completely enclosed by a container are the most significant exceptions to the Rule.
To whom does the Rule apply?
- The shipper, defined as “the person who initiates a shipment of food by motor vehicle or rail vehicle.” Because the shipper is presumed to be the party most “knowledgeable about all factors concerning the food, e.g., its packaging and holding temperature requirements, relevant to its sanitary transport,” it bears significant responsibilities under the Rule.
- The carrier, defined as “the person who owns, leases, or is otherwise ultimately responsible for the use of a motor vehicle or rail vehicle to transport food.” A person is “ultimately responsible,” and thus a carrier, even if the physical act of carrying is performed by other persons, such as a driver that is either employed or contracted by a trucking firm to operate the vehicle.
- The receiver, defined as “any person who receives food after transportation, whether or not that person represents the final point of receipt for the food.”
The proposed rule applies with equal force to interstate and intrastate transport of food but—again—not to food that is transshipped through the United States.
What does the Rule require?
Clean vehicles and transportation equipment. The Rule requires that vehicles and transportation equipment be designed, maintained and stored in a manner that prevents transported food from becoming “filthy, putrid, decomposed or otherwise unfit for food and to prevent the harboring of pests.” By way of example, the Rule requires that:
- All food-contact surfaces be cleanable;
- Surface coatings on vehicles and transportation equipment be corrosion-resistant and free of chips and flakes;
- All pallets be in good working condition, without (for example) jagged wood edges that could damage packaging and lead to a food’s exposure; and
- All equipment used in bulk food transfer operations, such as pumps and hoses and tankers, be thoroughly washed after each use.
As proposed, the Rule has detailed regulations pertaining to foods that require time/temperature controls to limit the growth of pathogens and otherwise ensure their safety, which it refers to as “TCS foods.” Under the Rule, carriers must provide training, both upon hire and as needed thereafter, to personnel engaged in the transportation of food. FDA envisions that such training could be provided online, in a half-day course similar to basic hazmat employee training. Carriers will need to document and maintain appropriate records of the training, which would be subject to the Rule’s recordkeeping requirements.
Under the Rule, shippers and carriers engaged in the transportation of human and animal food will be required to maintain most documents required by the Rule for a period of 12 months after they have been issued or cease to apply. Similarly, any written procedures applicable to the cleaning, sanitizing and inspection procedures for vehicles and transportation equipment must be retained for 12 months after they have ceased to be in effect.
Can the Rule’s applicability be waived?
Yes. As expressly permitted by the regulation’s authorizing statute, 21 U.S.C. § 350e, the FDA can exempt any persons, vehicles or products from compliance with the Rule, so long as the waiver (1) will not result in conditions that would be unsafe for human or animal health and (2) will not be contrary to the public interest. FDA can issue a waiver on its own initiative, or any person subject to the regulation can petition for a waiver. Any petition for waiver will be published for comment.