Final Rule on Sanitary Transportation of Human and Animal Food

Posted in Regulatory Compliance

On April 6th, 2016, FDA published its final Rule on Sanitary Transportation of Human and Animal Food. The Rule is one of seven proposed under the Food Safety Modernization Act (FSMA).  Click Here for a link to the new rule.

With some exceptions, discussed in greater detail below, the new rule governs shippers, receivers, loaders and carriers who transport food in the United States by motor or rail vehicle, whether or not the food is offered for or enters interstate commerce.

In turn, the rule establishes new requirements for:

  • Vehicles and related transportation equipment: The new rule applies to the design and maintenance of vehicles and transportation equipment to ensure they not cause the food being transported to become unsafe.  For instance, they must be both suitable and adequately cleanable for their intended use, and also capable of maintaining temperatures necessary for the safe transport of food.
  • Transportation operations: Under the new rule, specific measures must be taken during the transportation of food to ensure food safety, such as adequate temperature controls, preventing contamination of ready-to-eat food from raw food, protecting food from contamination from non-food items in the same load (or from the previous load), and protecting food from cross-contact, which would include hazards such as the unintentional incorporation of a food allergen.
  • Training: The new rule requires carriers to train their personnel in sanitary transportation practices and to also document the training conducted. This training is required to be provided whenever the carrier and shipper agree that the carrier is responsible for sanitary conditions during transport.
  • Records: The new rule also requires regulated parties to maintain records of written procedures, agreements and training records (required for carriers). The required retention time for these records will depend upon the specific type of the record involved, and when the regulated activity occurred, but will typically not exceed 12 months.

Notably, the FDA’s Sanitary Transportation is designed to address persistent food safety and sanitation issues within the industry.   The history of new rule can be traced back to the 1980’s.  During that period, numerous food safety concerns led regulators to create basic sanitary transportation standards. Concerns ranged from trucks being used to carry both food and landfill waste, to tankers being used to carry both ready-to-eat foods and raw eggs.  Some of these failures led to foodborne illness outbreaks.

To address these concerns, Congress enacted the Sanitary Food Transportation Act in 1990.  This was followed by the Sanitary Food Transportation Act of 2005.  Unfortunately, many of the safeguards that carriers were required to implement under those rules were deemed inadequate.  In turn, the final rule published under FSMA addresses some of the more significant inadequacies.

Subject to certain exceptions, the new rule governs shippers, receivers, loaders and carriers who transport food in the United States by motor or rail vehicle, whether or not the food is offered for or enters interstate commerce.  Basically, if you load, receive, or transport human or animal food that is not entirely enclosed, or if it must be temperature controlled and is shipped via truck or rail, you are subject to the new requirements.   Based on the size of your operation, you have either 1 year or 2 years to implement the new rules.  Companies that are exempted include those who transport Grade A milk and milk products, shippers that have less than $500,000 in average revenue, farmers, transporters of completely enclosed food products (unless the product needs to be controlled by temperature) and those that transport live animals other than certain shellfish.  If a carrier ships a food product that originates from another country and is only being transshipped through the US (not consumed here), and that food product will be exported, then the carrier is also exempt.

Under the new rule, carriers are allowed to continue to use the “best practices” they have previously and successfully implemented.  These are defined as “commercial or professional procedures that are accepted or prescribed as being correct or most effective.”  Such practices include successful sanitation procedures, effective training programs, record retention procedures and successful inspection and monitoring programs.

Under the new rule, FDA also allows the shipper and carrier to “agree to a temperature monitoring mechanism for shipments of food that require temperature control for safety.”  If there is any kind of material temperature failure, however, the carrier must take steps to ensure that unsafe food is not sold or distributed.  Additionally, FDA places full responsibility of the safe handling and shipping of the food directly on the shipper.  Although the shipper may shift some of the responsibility to those who load or receive a product, they can only do so if it is mutually agreed upon and signed by all parties.

Notably, an additional area FDA felt was neglected in previous rules was loading operations.  Being an integral part of the shipping spectrum, FDA requires that special care now be taken to ensure that loaders comply with the regulations and follow their own set of best practices.

So, what must companies do to comply with the rule?  Well, all companies need to develop and implement a written procedure governing all aspects of their shipping operations.  This procedure should spell out in detail the sanitation procedures for both the loading and shipping equipment.  If current best practices are not suitable, then changes in procedure or design must take place.

All companies should also develop programs to ensure that previous shipments did not adversely impact the safety of the food.  Previous manifests should be reviewed, and proper cleaning procedures must take at all stages to ensure that the next shipment is safe.  Additionally, managers and employees must be trained on how to identify areas of concern and how to remedy any deficiencies.  Employees must also be trained to identify hazards or failures and know how to isolate affected products and report issues to their chain of command.  All training documentation must be retained for at least 12 months.  As for temperature controls, these too must be written down as a procedure and implemented.

As our food processing plants continue to make great strides in safe food production, the importance of safe transportation has become equally important.  Make sure your programs are sufficient and will withstand FDA scrutiny.  A single food safety failure at any stage in transportation can have disastrous civil, regulatory and criminal consequences.