Twenty-five years after Congress first tried to ensure that garbage trucks aren’t also used to haul fresh produce, a federal regulation establishing sanitation standards for the transportation of human and animal food by truck and rail is finally imminent - relatively speaking, that is. By court order, the Food and Drug Administration (FDA) must publish its final rule on the matter by March 31, 2016, twenty months after the comment period closed in July 2014.
Affected companies might be forgiven for having bided their time. 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. Companies likely to be affected should start familiarizing themselves with the rule in its proposed form and consider whether changes are warranted. 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.
The 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;
- that surface coatings on vehicles and transportation equipment be corrosion-resistant and free of chips and flakes;
- that 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
- that all equipment used in bulk food transfer operations, such as pumps and hoses and tankers, be thoroughly washed after each use.
Policies that ensure compliance and accountability. The Rule requires that shippers, carriers and receivers:
- establish accountability, by assigning to a competent supervisor the responsibility of ensuring compliance;
- conduct all transportation operations under conditions and controls that eliminate the risk of contamination or adulteration (for example, by having policies in place that will prevent food requiring refrigeration from being left out on a loading dock); and
- take effective measures, such as the segregation of raw foods and non-foods and the establishment of strict hand-washing protocols, to protect food from contamination or cross-contact during transportation.
- N.B. Shippers and receivers should review their transportation contracts to make sure they include provisions aimed at maximizing compliance with the Rule by carriers. For example, carriers should warrant the existence of policies requiring drivers to wash their hands before handling transported food, especially open or exposed raw or fresh foods; or carriers that transport bulk milk for other parties should be contractually obligated to provide wash tickets and maintain records.
Other provisions are specific to shippers, receivers and/or carriers:
- Each shipper must:
- specify, in writing, all requirements - including design and cleaning requirements - that carriers must satisfy in order for their vehicles and equipment to be deemed sanitary in the context of specific shipments. For example, shippers are responsible for advising carriers of particularized equipment needs (such as thermally insulated tanks) and preparation steps (such as specific wash procedures) applicable to their shipments. The written specifications are subject to document retention obligations specified elsewhere in the Rule.
- For products not completely enclosed in containers, shippers must conduct visual inspections of the vehicles and equipment - prior to loading - to ensure cleanliness and compliance with the shipper’s written specifications. Vehicles must be free of pest residue, mold, mildew, excess water, ice buildup, dirt, holes, cracks and other issues that could compromise the shipment’s integrity.
- Each shipper and receiver must provide vehicle operators who are expected to handle food not completely enclosed by a container with access to a suitable hand-washing facility.
- Each carrier must:
- supply vehicles and transportation equipment that conform to the shipper’s specifications, and which are appropriate to the goal of preventing contamination;
- if transporting bulk food, and unless the shipper and carrier otherwise agree in writing and in advance, advise the shipper of the three previous cargoes transported in the vehicle, and provide the shipper with a description of the most recent cleaning procedures; and
- develop and implement various written procedures that (like any agreement with a shipper regarding the transportation of bulk foods) are subject to the Rule’s record retention requirements, such as specifications for cleaning, sanitizing, and inspecting vehicles and transportation equipment.
- N.B. Carriers should not assume that shippers will be held solely responsible if written requirements are not supplied and contamination results. Carriers intent on minimizing liability should make a habit (or a policy) of asking shippers what might be necessary to ensure the safe and sanitary transportation of food -and documenting the response. Among other uncertainties, it is far too early to know whether the Rule will pre-empt state law claims against carriers, even if the shipper has provided detailed specifications with which the carrier has fully complied.
Specific precautions for TCS food. 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.”
- Vehicles used to transport TCS foods must be designed and equipped to maintain the food at the requisite temperature. Each freezer and mechanically refrigerated (as opposed to insulated) cold storage compartment must have a thermometer or other temperature-recording device that accurately reflects the temperature.
- Shippers, carriers and receivers are charged generally with making sure that TCS food is transported in such a way that it remains wholesome. In addition, the Rule sets forth various specific requirements, including the following.
- Unless TCS food is being transported in a thermally insulated tank, the shipper must provide written specifications to the carrier as to temperature and pre-cooling requirements, and must verify proper pre-cooling before loading.
- The carrier of TCS food must ensure that the food is transported under acceptable temperature conditions. Upon delivery, the carrier must demonstrate to the shipper (and, upon request, to the receiver) that the food was so transported by “any appropriate means,” such as a printout of the time/temperature recording device. (However, the carrier and the shipper may agree in writing, before the shipment, to shift these obligations to the shipper.)
- Shippers and receivers must load and unload TCS food under conditions that will prevent microbial growth or other adulteration; for example, they may not leave it on a hot loading dock.
- Carriers must develop written procedures addressing how they will comply with requirements applicable to TCS foods.
Food safety-specific training for carrier personnel. Under the Rule, carriers must provide training, both upon hire and as needed thereafter, to personnel engaged in the transportation of food. At a minimum, the training must cover:
- food safety problems that may occur during food transportation,
- basic sanitary practices to address those potential problems, and
- carrier responsibilities under the Rule.
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.
The retention of certain records for a designated period of time. 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. So, for example, a shipper who provides a carrier with written sanitation specifications applicable to a particular shipment, as required, must retain a copy of those instructions for at least 12 months. 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.
In addition to the 12-month rule, the following provisions apply:
- Shippers and carriers receiving FDA requests for records must comply in a prompt manner, usually within 24 hours.
- Records must be kept either in their original form, as a true copy, or in electronic form.
- All records may be stored offsite after six months following the date that the record was made, provided that such records can be retrieved within 24 hours of a request for official review.
- N.B. Documents that are created pursuant to the Rule, and subject to its record-retention requirements, are likely also subject to public disclosure via the Freedom of Information Act (FOIA) and other statutory authority once obtained by the FDA.
Can the Rule’s applicability be waived?
Yes. As expressly permitted by the regulations’ authorizing statute, 21 USC § 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. The 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.