On April 6, 2016, the Food and Drug Administration (FDA) published its Final Rule on the Sanitary Transportation of Human and Animal Food (the Final Rule). These long-awaited regulations were mandated by the Food Safety Modernization Act of 2011.
The bad news is that this burden will mean that freight brokers—specifically included in the Final Rule’s definition of “shipper”—must meet requirements for sanitarily transporting food within the United States by motor and rail vehicles.
The good news is that the Final Rule relies on existing industry best practices. For example, shippers and carriers may agree to a temperature monitoring mechanism for shipments of food that require temperature control for safety. Also, contrary to the proposed regulations, broken seals or evidence of tampering will not create a presumption of adulteration, absent any evidence of actual threats to the public health.
Who Is Covered?
In addition to shippers and brokers, the Final Rule applies to receivers, loaders (a new covered category of persons that load food onto a motor or rail vehicle during transportation operations) and carriers. The Final Rule also applies to international shippers exporting food to the U.S. in a freight container, by ocean or air, when all of the following are met:
- An intact container is to be transloaded onto a motor or rail carrier;
- The food is destined for transport in U.S. commerce; and
- The food will be consumed or distributed within the United States.
Food with safety concerns is prohibited from admission into U.S. commerce.
The Final Rule has the following eight notable exemptions:
- Shippers, receivers or carriers engaged in food transportation operations that have less than $500,000 in average annual revenue
- Transportation activities performed by a farm
- Transportation of food that is transshipped through the United States to another country
- Transportation of food that is imported for future export and that is neither consumed nor distributed in the United States
- Transportation of compressed food gases (e.g., carbon dioxide, nitrogen or oxygen authorized for use in food and beverage products), and food contact substances
- Transportation of human food byproducts transported for use as animal food without further processing
- Transportation of food that is completely enclosed by a container, except a food that requires temperature control for safety
- Transportation of live food animals, except molluscan shellfish
The Final Rule applies to foods that are already regulated under the federal Food, Drug and Cosmetic Act, but do not fall within the aforementioned exemptions, including pet food and feed for livestock, food additives and dietary supplements.
Comments by the FDA in the Final Rule indicate that, while not expressly excluded by the regulation, the “transportation of frozen food is not subject to this rule” because the temperature and time required for a frozen food to become thawed and unsafe would result in “significant quality issues” for the food before posing any “safety risk.”
Required Written Instructions and Procedures
Of great importance, brokers must specify in writing to carriers and, when necessary, loaders, any particular criteria that must be met to ensure safe and sanitary food transport. These requirements may include design specifications, cleaning procedures and operating temperatures (with any necessary pre-cooling phase), unless the carrier is transporting the food in a thermally insulated tank.
Further, brokers are required to develop and implement written procedures to ensure that:
- Vehicles and equipment used for transporting food are in an appropriate sanitary condition, including any necessary cleaning or sanitizing practices and inspection requirements
- Previous cargo does not make the food unsafe, when transporting food in bulk
- Food is transported under adequate temperature control when required for safety
The Final Rule requires brokers to retain records demonstrating that they have provided information to carriers about the necessary sanitary requirements for a vehicle and the requisite temperature conditions for temperature-controlled food. Specifically, the Final Rule indicates that:
- These records must be held for a period 12 months beyond the termination of the agreements with the carriers.
- Written agreements and written procedures must also be held for a period of 12 months beyond when those agreements and procedures are used.
- Brokers will be required to make all records available to duly authorized individuals promptly upon written or oral requests.
- Those records must be kept as original, true copies (such as photocopies, pictures, scanned copies, microfilm, microfiche or other accurate reproductions of the original records) or electronic records.
- Off-site storage of records is permitted, except for written procedures, so long as the records can be retrieved and provided on-site within 24 hours of a request for official review.
Small businesses, defined by the Final Rule to include: (1) businesses other than motor carriers that are not also shippers and/or receivers that employ fewer than 500 full-time equivalent employees and (2) motor carriers with less than $27.5 million in annual receipts, have until April 6, 2018, to comply.
All other covered businesses (besides small businesses) must comply with the Final Rule by April 6, 2017.
What Can Brokers Do To Limit Their Liability?
If there is a possible temperature control failure, then the food cannot be legally distributed or further released into the food supply chain until a safety determination has been made by a “qualified individual.” Failure to comply with the Final Rule could lead to civil and criminal penalties for brokers if the food becomes adulterated while in transit, and the broker does not take steps to prevent the food from moving further along the food supply chain such that it could cause public harm.
Under the Final Rule, brokers can and should contractually assign their responsibilities to other covered parties such as a receiver, loader and/or a carrier. Brokers may consider revising their broker/carrier agreements to go beyond the minimum that is required under the Final Rule, and to contractually specify that if the carrier does not follow the shipper’s instructions, then the shipment will be considered adulterated, and the carrier will be held liable.
Then, if a shipper requires that a seal remains intact during transport, and a consignee or receiver refuses the shipment because the seal is broken, the carrier could be held liable under the contract even though it would not necessarily be held liable under the Final Rule.
At a minimum, brokers should:
- Protect themselves contractually
- Determine whether or not a shipment is subject to the new regulations, and not assume unnecessary obligations .
- Not accept shipper requirements that cannot be met operationally