As Food Safety Modernization Act (FSMA) compliance deadlines start to hit, many companies are waking up to the idea that the law truly represents a change for the entire food supply chain, all the way from farm to fork. The next set of FSMA rules—Sanitary Transport of Human and Animal Food—is scheduled to be published on March 31, 2016. On the date of publication, when the U.S. Food And Drug Administration (FDA) posts the final rules in the Federal Register, the clock starts ticking for companies to comply. The implementation phase and compliance deadlines will vary by company size. Typically for FSMA compliance, large companies will have 1 year to adhere to the stipulations laid out in the rules, medium-size companies will have 2 years and small companies will have 3 years.

While not the largest in scope compared with other FSMA laws, rules for the Sanitary Transportation of Human and Animal Food still represent a significant and comprehensive change to how food will reach consumers. Almost all the food we eat, whether purchased from a grocery store or a restaurant, is shipped somehow—either by truck, rail, air or shipping containers. The new rules will have a marked effect on how all businesses that transport food will operate going forward. It is important for those along the entire food manufacturing chain to understand what the rules entail and who will be affected by them.  

Primary Concepts
While the mandates will not take their final form until they are submitted, the rules have already entered the proposed-rule phase and have been open for comments. Therefore, not many surprises are expected. In general, FSMA has been all about prevention, and this set of rules will continue to follow that theme. The goal will be to prevent practices that create food safety risks during the transportation of food.

The rules entail three primary concepts in regard to preventing the adulteration of food during transportation. The first is that food must be kept at the proper temperature during shipment. Numerous products, such as eggs and milk, must be refrigerated throughout the entire process. This will require the proper precooling of the vehicle as well as certifying that it maintains the appropriate temperature during shipment. Ensuring this is done correctly is vital for preventing bacterial growth and maintaining the integrity of the food.

Secondly, vehicles must be cleaned between loads to prevent any possible contamination from the previous shipment. Maintaining the separation of food and nonfood items will serve to inhibit chemical contamination as well. Nonfood products—such as batteries—should never be shipped in the same vehicle as food products. Additionally, allergens, which are the leading cause of food recalls managed by companies and the FDA, must be separated in a similar manner.[1] If a carrier of bulk liquids were to go from transporting a dairy product to a nondairy product, the potential for residual of a dairy allergen is high and must be properly communicated and addressed.

The third concept relates to protecting the product from outside exposure during transportation. Understanding and mitigating any potential exposure problems that can occur is essential for maintaining food safety. For instance, a shipper of fresh produce, which is not typically completely enclosed by its container, may require a carrier to pick up only other similar fresh produce or goods packaged in a sealed container along its route.

The upcoming FSMA rules are designed to help guarantee these three concepts are followed closely. This will be achieved by mandating certain procedures throughout the food shipping process as well as implementing strict record-keeping measures.

Who Will Be Affected?
Each member of the food manufacturing chain will be affected in some way by the FSMA rules—from shippers and carriers to receivers. Specifically, shippers will be responsible for inspecting the cleanliness of the transport vehicle before loading the product. They must fully inspect the vehicle for any potential risks that could lead to the contamination of the food product during transportation, which includes checking the temperature of the vehicle. If problems are found within the vehicle, it will be rejected and the shipper will request that the carrier bring in a new one. This inspection process is, in fact, already a best practice for many food manufacturers looking to protect their product from adulteration.

Another important aspect of the regulation, which will impact each member in the process, will be the exchange of information. Information concerning the type of food product, the proper temperature necessary and the cleaning procedures required and performed will generate large and complex data. These data sets must be shared among the three groups to ensure that rules are implemented properly. Handling all of the information created may prove to be one of the biggest challenges presented by the rules. Therefore, enhancements in record-keeping—a staple of FSMA rules in general—will be critical in enabling accurate exchange of information.

There are a few important exceptions to who will be affected by this set of FSMA laws. Perhaps most noteworthy, shelf-stable food in its final packaging will not be covered by the law. For products in this category, such as canned food, the opportunities for contamination are minimal, as they are packaged into their final container and do not require refrigeration. Additionally, small companies, with total annual sales less than a half-million dollars, are likely to be exempt—whether they be a shipper, carrier or receiver. Farmers who transport agricultural commodities within the confines of the farm itself will not be covered either. However, once the food product leaves the farm, possibly en route to a food production facility, transporters must adhere to the rules set by FDA. Food that is transshipped through the U.S., meaning that it is not made or consumed here, will be exempt as well. The rules will also not apply to live animals or compressed food gases, like nitrogen.

Where to Get More Information
There is a great deal to learn about FSMA’s Sanitary Transportation of Human and Animal Food regulations and how they will impact each member in the food supply chain. Updates to the regulation are available on FDA’s website[2], and as the publication deadline approaches, more information will undoubtedly be forthcoming.   

Jeffrey Barach, Ph.D., is a food scientist who has been responsible for research and development, regulatory liaison activities, teaching, problem solving and troubleshooting. He is a subject-matter expert on issues related to food safety, biotechnology, food irradiation, nanotechnology and other new processing and testing technologies, and serves as a FSMA-qualified individual. He also serves as a consultant on FSMA to PMMI, The Association for Packaging and Processing Technologies.

References
1. www.fda.gov/forconsumers/ucm416577.htm.
2. www.fda.gov/aboutfda/reportsmanualsforms/reports/economicanalyses/ucm416394.htm.