The Food and Drug Administration (FDA) Food Safety Modernization Act (FSMA) rule on Sanitary Transportation of Human and Animal Food is now final. This rule is in place to advance the FDA’s efforts to protect foods from farm to table by making sure the food is safe during transportation. The rule institutes sanitary requirements for shippers, loaders, carriers by motor or rail vehicle, and receivers included in transporting human and animal food. The FSMA rule authenticates requirements for vehicles and transportation equipment, transportation operations, records, training, and waivers.
Since 2013, seven rules have been proposed regarding a modern, risk-based framework for food safety. This rule is intended to prevent practices during transportation that create food safety risks. There have been concerns about the need for new regulations to ensure that food is being transported in a safe manner since 2005 when there was an outbreak of illness due to human and animal food contamination. Some of these risks could be the failure to properly refrigerate food, inadequate cleaning of vehicles in between loads, and failure to properly protect food.
Who is covered?
- 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.
- Persons, e.g., shippers, in other countries who ship food to the United States directly by motor or rail vehicle (from Canada or Mexico), or by ship or air, and arrange for the transfer of the intact container onto a motor or rail vehicle for transportation within the U.S., if that food will be consumed or distributed in the United States.
- The rule does not apply to exporters who ship food through the United States (for example, from Canada to Mexico) by motor or rail vehicle if the food does not enter U.S. distribution.
- Companies involved in the transportation of food intended for export are covered by the rule until the shipment reaches a port or U.S. border.
*Information gathered from The FDA
- Vehicles and transportation equipment: The design and maintenance of vehicles and transportation equipment to ensure that it does not cause the food that it transports to become unsafe. For example, they must be suitable and adequately cleanable for their intended use and capable of maintaining temperatures necessary for the safe transport of food.
- Transportation operations:The measures taken during transportation to ensure food safety, such as adequate temperature controls, preventing contamination of ready to eat food from touching raw food, protection of food from contamination by non-food items in the same load or previous load, and protection of food from cross-contact, i.e., the unintentional incorporation of a food allergen.
- Training:Training of carrier personnel in sanitary transportation practices and documentation of the training. This training is required when the carrier and shipper agree that the carrier is responsible for sanitary conditions during transport.
- Records:Maintenance of records of written procedures, agreements, and training (required of carriers). The required retention time for these records depends upon the type of record and when the covered activity occurred but does not exceed 12 months.
*Information gathered from The FDA
The Sanitary Food Transportation Act (SFTA) allows the agency to waive the requirements of this FSMA rule if it determines that the waiver will not result in the transportation of food under conditions that would be unsafe for human or animal health, or contrary to the public interest (FDA, 2017).
According to the FDA website, the FDA has published three waivers for businesses whose transportation operations are subject to Federal-State or local controls. They include:
- Businesses that hold valid permits and are inspected under the National Conference on Interstate Milk Shipments’ Grade “A” Milk Safety Program, only when engaged in transportation operations involving bulk and finished Grade “A” milk and milk products.
- Businesses that are permitted or otherwise authorized by the regulatory authority to operate a food establishment that provides food directly to consumers (including restaurants, retail food establishments, and nonprofit food establishments, as defined in 21 CFR 1.227), only when engaged in transportation operations as:
- Receivers, whether the food is received at the establishment itself or at a location where the authorized establishment receives and immediately transports the food to the food establishment;
- Shippers and carriers in operations in which food is transported from the establishment as part of the normal business operations of a retail establishment, such as: delivery of the food directly to the consumer(s) by the authorized establishment or a third-party delivery service or delivery of the food to another location operated by the authorized establishment or an affiliated establishment where the food is to be sold or served directly to the consumer(s).
- Businesses that are appropriately certified and are inspected under the requirements established by the Interstate Shellfish Sanitation Conference’s National Shellfish Sanitation Program (NSSP), only when engaged in transportation operations involving molluscan shellfish in vehicles that are permitted by the State NSSP certification authority.
Click here to read more about the three waivers added to the final rule.
Recognizing that businesses, especially small businesses may need more time to comply with the requirements, the compliance dates are adjusted accordingly.
- Small Businesses – businesses other than motor carriers who are not also shippers and/or receivers employing fewer than 500 persons and motor carriers having less than $27.5 million in annual receipts would have to comply two years after the publication of the final rule.
- Other Businesses – a business that is not small and is not otherwise excluded from coverage would have to comply one year after the publication of the final rule.
*Information gathered from The FDA
Exempt from the Rule
- 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 or distributed in the United States
- Transportation of compressed food gasses (e.g. carbon dioxide, nitrogen or oxygen authorized for use in food and beverage products), and food contact substances
- Transportation of human food by-products transported for use as animal food without further processing
- Transportation of food that is completely enclosed by a container except for a food that requires temperature control for safety
- Transportation of live food animals, except molluscan shellfish
*Information gathered from The FDA
What does this mean for Columbian?
At Columbian, safety is our number one value. That being said, it is our highest priority to make sure that not only our employees are safe, but our customers and their products are safe as well. We specialize in food safety at Columbian and want to make sure that we are doing everything in our power to perform at the safest level.
At the warehouse level, Columbian’s role in the Sanitary Transportation Act is a small piece of the process, but vital to ensure that the food safety supply line is safe and suitable for further food processing at the manufacturing plants and distribution centers for finished products. Columbian does not transport bulk/open food. Temperature control in trailers is typically not an issue due to Columbian’s average length of haul.
Columbian’s primary role in the Sanitary Transportation Rule is to identify potential food safety risk at the point of receipt and in our trailer inspection processes. This is done by obtaining regulatory standards, and customer requirements relating to refrigeration loads in the warehouse process product flow. At this point, we know that we need clean trailers that are suitable for receiving and shipping of food grade materials from customer suppliers and to our customer designation sources.
Trailers that come into Columbian facilities must abide by our clean trailer rules. This process has been developed by Columbian’s food safety experts to ensure that trailers are clean before coming in contact with our facilities. Drivers are notified that their trailer will be rejected if it has any of the following:
- Sharp, hard plastics
- Infestation of any kind
- Allergen contamination
- Strong or unusual odors
- Blood or blood stains
A refrigerated trailer (sometimes referred to as a reefer), on the other hand, is a different process because it involves handling sensitive perishable goods that require controlled temperatures. Refrigerated transportation is usually driven by our customer requirements, which coincide with national and international standards. Once we have this information, we do the following:
- Provide training for our employees on the reefer process.
- Confirm Security seals are attached the load
- Check the reefer settings on the trailer before unloading product, and recording those temperature readings on inbound paperwork
- Per customer or in-house procedures, we periodically check temperatures at designated points as we unload the trailer in order to ensure consistent temperature distribution throughout the trailer. The periodic temperature tests are also documented on the inbound paperwork.
- As we unload, the driver visually inspects the product and trailer for defects that may compromise the product integrity.
- All nonconforming issues to product condition, temperature, and trailer conditions (mentioned above), are rejected at this point in the receiving process and reported to the customer for remedial actions.
- Outbound loads follow the same process as inbound loads. However, there are two exceptions. First, we must make sure the temperature is preset and the temperature inside the trailer is at the customer’s required temperature before loading. Secondly, we do not periodically check temperatures as we load product on the trailer.
Columbian always considers new rules and laws when creating new safety procedures. Columbian continues to strive for the safest environment for employees, customers, and product.
Click here to read more about the final rule on Sanitary Transportation of Human and Animal food.