From 1976 to 2009, the U.S. Food and Drug Administration (FDA) issued several regulations and guidelines that addressed the transportation of food products. However, each of these regulations and guidance documents was limited in scope as it related to a particular circumstance or segment of the food supply.[1] In 1990, the Sanitary Food Transportation Act (1990 SFTA) was passed by Congress, which required the U.S. Department of Transportation (DOT) to establish regulations to promote the safe transportation of food.[1] Moreover, the 1990 SFTA required the secretary of transportation (by July 31, 1991) to prescribe regulations to prohibit the transportation of food and food additives in motor vehicles or rail vehicles that were used to transport non-food products that would make the food and food additives unsafe for humans or animals.[1] The DOT failed to issue regulations as required by the 1990 SFTA. Instead, it referenced requirements and guidance documents by the U.S. Department of Agriculture (USDA) and FDA on the safety and defense of food during processing, transportation and storage. Additionally, the DOT concluded, “The expertise for ensuring the nation’s food supply, including transportation, lies with USDA and FDA.”[2] These actions by DOT may well have been the impetus for the passage of the National Economic Crossroads Transportation Efficiency Act (NEXTEA) in 1997. The NEXTEA included provisions to transfer primary oversight of food transportation safety from the DOT to FDA, and required FDA develop and implement regulations to ensure the safe transportation and storage of food, whether the food was transported by road, rail, air or sea.[3] However, it is safe to say that for the years that followed, FDA failed to issue the required regulations to ensure the safety of food during transportation, even while the nation’s food supply chain was being globalized and food transportation was widely diversifying beyond traditional rail and road systems.

Congress passed The Bioterrorism Preparedness and Response Act of 2002 (Bioterrorism Act), which focuses on food defense: the intentional adulteration of food. The Bioterrorism Act calls for a number of provisions within the food supply chain, which include but are not limited to: 1) chain of custody record maintenance by food transporters; 2) facility registration for domestic and foreign sites that manufacture, pack and store food for consumption in the U.S. and 3) prior notification of imported food within the U.S. The Bioterrorism Act “differs from ‘traditional’ food safety, which is the effort to prevent unintentional contamination of food products by hazards…”[4]

In 2005, Congress revised the 1990 SFTA with a series of amendments and enacted the Sanitary Food Transportation Act of 2005 (2005 SFTA), which transferred regulatory responsibility for the safe transportation of food from the DOT to FDA. The law requires FDA to promulgate regulations addressing sanitary transportation of food to ensure food is transported under conditions that will not render it unsanitary or adulterated.[5] The 2005 SFTA also mandates transportation-related record keeping, facilitating forward and backward traceability of food to its destination and origin, respectively. Unfortunately, the transportation-related record keeping has been largely ignored within the food supply chain. The Office of the Inspector General issued a report in March 2009 with the findings that 59 percent of 118 food facilities studied failed to meet the requirements of the 2005 SFTA directive on record keeping.[6]

As part of FDA’s attempt at rule making for the 2005 SFTA, another guidance was issued in April 2010 through the Advance Notice of Proposed Rulemaking (ANPRM) process. FDA stated in the ANPRM, “This action is also part of a larger agency effort to focus on prevention of food safety problems through the food chain.” While the April 2010 guidance document contains specific practices to ensure the sanitary transportation of food, the guidance was not finalized. Once more, the U.S. food supply chain remained vulnerable and the public at risk, while food transportation continues to diversify beyond road and rail to rapidly include sea and air.

Congress passed the Food Safety Modernization Act (FSMA) in 2010, which became law in 2011.[7] While FSMA is primarily focused on preventing illness from unintentional contamination, it also contains mandates to strengthen food defense.[4] FSMA addresses the sanitary transportation of food in Section 111 and states that within 18 months following the enactment of FSMA, FDA is required to promulgate regulations that require shippers, carriers by motor vehicle or rail and other persons engaged in the transportation of food to use sanitary transportation practices to ensure food is not transported under conditions that may render it adulterated.[8] Additionally, FDA is required to conduct a study on the transportation of food in the U.S., including air transportation, and to examine the unique needs of rural and frontier areas regarding safe food delivery. Unfortunately, FDA has again missed a critical deadline to issue regulations to safeguard the nation’s food supply during transportation.

The Stage Was Set
For more than a decade, the U.S. food supply chain has undergone substantial globalization, driven primarily by economic pressures, population diversity and intense competition among leading food companies to dominate market share. In recent years, the U.S. food supply chain has experienced significant increases in imported food, with a dramatic shift toward finished products where previously imports have been primarily raw materials.[9] The growth, globalization and variety of imported food (both raw materials and finished products) have led to increased complexity within the supply chain. The Federal Food Safety Working Group Progress Report, issued December 2011, stated that “…Food imports are growing rapidly and now comprise 15 percent of the total U.S. food supply, with much higher portions being imported in key categories, including: seafood (75–80 percent), fresh fruit (about 50 percent) and vegetables (about 20 percent).”[10] Foods account for 59 percent of FDA-regulated imported products, with an entry inspection of below 2 percent of all imported foods.[4] FDA estimates that U.S. consumers purchased $2 trillion worth of imported products in 2007. These products came from 825,000 importers through more than 300 U.S. ports of entry. In addition, the volume of imports could double every 5 years, according to FDA staff. FDA Commissioner Margaret Hamburg has reported an estimated 24 million food import entries into the U.S. in 2011 compared with about 12 million entries in 2007. While the data are not readily available, it would appear that the upward trend in import numbers would also imply a transformation in the mode of delivery. Historically, most shipments into the country would have arrived in transborder shipments aboard trucks. Sea containers would likely have been the next important mode, but it now appears that more and more food and food ingredients arrive in this country by air transport, a new paradigm with new risks and hazards.

The U.S. food supply is one of the safest in the world. However, for about a decade, the U.S. food supply chain has seen increased food safety risks from non-intentional and intentional contamination, resulting in foodborne illness and substantial costs.

The total societal cost of foodborne illnesses in the U.S. may be as much as $152 billion per year, according to a recent report from the Produce Safety Project at Georgetown University.[4] Officials at the U.S. Centers for Disease Control and Prevention and FDA report that preventing foodborne illnesses will improve public health, reduce medical costs and avoid costly disruptions of the food system caused by outbreaks and large-scale product recalls.[11, 12]

Growth in the variety of foods, sourcing locations, manufacturing processes and multiple modes of transportation within the nation’s food supply chain has created a discourse about food safety and food defense during transportation and storage. Food safety and food defense experts have questioned whether the transportation industry can ensure the safety and defense of the nation’s food supply given current regulations. Although data on food safety failures directly attributed to transportation and storage are limited, investigation of several incidents has identified these processes as a root cause of failures.[3]

Planes, Trains, Trucks, Ships and Potential Hazards
    Transportation and storage are critical factors of any food supply chain. Unfortunately, without the required regulations, effective procedures may not be implemented to prevent abuse in food transportation and storage that may lead to failures and render ingredients and products unsafe for human consumption.
    The U.S. food transportation system has experienced a significant shift from over-the-road and rail to include air and waterways. Global food transportation has been reported to be 35 percent by land, 60 percent by sea and 5 percent by air.[13] However, some experts believe that air shipments of food across the U.S. are well beyond 5 percent. While this transition in food transportation was taking place, regulations did not keep pace to adequately protect the nation’s food supply. Although Congress has passed several laws (e.g., 1990 SFTA, 2005 SFTA and FSMA) that include directives for FDA to promulgate regulations to ensure the safety of food during transportation, FDA has failed to issue regulations to protect the U.S. food supply.

Common Concerns:
    There are four major modes of U.S. food transportation currently in operation, and there are hazards common to all four. Regardless of the transportation mode, conditions required to ensure the sanitary condition of the food depend on whether the food is refrigerated, frozen or shelf stable (including ready-to-eat or raw). In addition, considerations must be given to whether the food is categorized as an allergen. Food defense is also critical during transportation to prevent intentional sabotage and tampering. Given these concerns, several food safety and food defense experts have stated concerns for FDA’s failures to issue regulations to ensure the sanitary transportation of food to prevent adulteration. Some have asked whether transportation is the weak link[14] within the U.S. food supply chain, with undue risk from abuse during transportation and handling. General abuse that can lead to food safety concerns can come primarily from 1) sabotage and tampering, 2) temperature abuse or 3) cross-contamination.[3] These abuses can readily occur during food transportation if appropriate measures are not taken. FDA regulations will go a long way to ensure manufacturers and carriers work together to ensure safe and sanitary transportation of food, whether by trucks/rail, ship or aircraft.

Sabotage and Tampering:
    The terrorist events of September 11, 2001, heightened awareness that the nation’s food supply is a viable target to inflict mass destruction on the U.S. population, and that actions must be taken to ensure the safety of the nation’s food supply. Congress responded swiftly and passed the Bioterrorism Act to minimize risk to the food supply from threats such as biological, chemical and radiological agents. Notwithstanding the Bioterrorism Act, there are no regulations to address food defense during transportation. Manufacturers and transporters took the initiative and developed the standards the industry currently uses.  

Food sabotage and tampering during transportation can be managed through an effective food defense program, where the threats and what should be protected are identified, as are the vulnerable points in the system. Then, the most effective defense measures are developed and implemented. Food defense is different from food safety. Food safety addresses the unintentional contamination of food products by biological, chemical or physical hazards. Food defense addresses the intentional contamination of food products by biological, chemical, physical and radiological hazards to cause harm. Sabotage and tampering can be largely mitigated with tamper-evident seals, locks, personnel training, inspection, documentation and appropriate record retention. Each of these elements must be developed to address the vulnerabilities specific to the transportation mode to ensure prevention and detection of sabotage and tampering.  

Trucks and trains are by far the most common overland mode of transportation of food within the U.S. and between its trading partners, Canada and Mexico. Tamper-evident locks and seals are used to safeguard food during transportation, primarily when there is a full truckload and delivery is to a single destination point.  However, where there is a partial truckload as well as bulk food transportation, tamper-evident locks and seals are not standard practices. This leaves the food supply vulnerable. The use of tamper-evident locks and seals for all transported foods will greatly enhance food defense.

Food transportation from most international ports such as Asia, Africa and Europe is primarily conducted by ship and airline. Both modes have seen significant increase in food transportation to the U.S. due to the global expansion of imported foods. The Bioterrorism Act has defined defense requirements for imported food, and while it has brought focus to imported food defense, there is still much to be done.

The majority of exports of internationally manufactured foods to the U.S. are conducted through local brokers within the country of origin. Without frequent on-site inspection or on-site monitoring by U.S. company-owned resources at the point of origin, U.S. food companies that import food will find it difficult to confirm appropriate safety practices for food during storage and transportation to ports of departure. This is a concern for all shipments, especially for bulk shipments, where tamper-evident locks and seals are not in use. Testing for most hazards is difficult, costly and mostly impractical.

An effective way to mitigate food tampering during transportation is for U.S. food companies to collaborate with their food transportation providers (domestic and international) to develop and implement a viable food transportation defense program, including, but not limited to, tamper-evident locks, personnel training, monitoring and documentation.

Temperature Abuse:
Temperature abuse is most significant from a quality assurance and food safety perspective if temperature controls are not maintained to prevent microbiological growth. Freezing food is usually done to increase shelf life by inhibiting growth of both spoilage and harmful microorganisms. It is critical to maintain frozen food at appropriate temperatures during transportation to ensure the food’s quality and safety. Refrigerated storage and transportation is one of the most widely used methods to control microbiological growth in foods. A temperature of less than 40 °F will maintain the microbiological stability of refrigerated foods. Under FSMA, previous practices of loading refrigerated food on trucks precooled at less than 41 °F will be considered insufficient as the only temperature control program. Distributors are required to maintain a temperature of less than 41 °F during the entire transportation of the food. Temperature control and monitoring devices should be installed in trailers to ensure this practice is implemented.

Concerns for temperature abuse of food during transportation usually center on long-distance transportation for all modes. The Federal Register reported in April 2010[15] that the Motor Carrier Division of the Michigan State Police listed findings that trucks were carrying raw poultry in refrigerated trucks where the temperatures were as high as 70 °F. The report indicated refrigeration units were either turned off, incorrectly set or not working. During long transportation cycles, temperature abuse can occur either from carriers turning off the refrigeration or freezer unit, or from malfunction of the units. International transportation of food by ship can undergo significant temperature variations due to outside temperature differences in transit. This was indicated in a study by Tanner and Estrada-Flores,[16] where the temperature impact on frozen fish on a sea container was demonstrated over a 20-day transportation period.

With respect to the four major modes of U.S. food transportation currently in operation, air transportation has the least reported information and is probably the most vulnerable to abuse. While major cargo transporters have been reported to provide some measures to address temperature maintenance during transportation, this effort is primarily for pharmaceutical transportation. The use of temperature control mechanisms is generally stated by manufacturers to provide temperature control for 100 hours. However, such units are not readily used for food transportation. At best, most air carriers have limited refrigerated accommodations and depend on customers delivering goods requiring refrigeration within strict timelines and already packaged under temperature control. The issue with such practices is the time the food remains on the loading dock and the airplane is held at either the gate or the runway. That waiting time can cause the food to experience temperatures well above 40 °C before departure, impacting food quality and microbiological stability.
 
With the growing use of airline transportation of food, until FDA regulations are promulgated, food distributors must take all necessary precaution to prevent temperature abuse of food.

Cross-Contamination:
    Cross-contamination of food is critical in the safety of food and is a significant issue during food transportation by all transportation modes. Food cross-contamination during transportation can occur due to harmful microorganisms being transferred from one product to another. Another aspect of cross-contamination is the cross-contact of an allergen-containing product either through palletizing or improper cleaning of transport vehicles and containers after transportation of allergen-containing products. This is particularly important in bulk food transportation. Partial shipments pose a high risk for food cross-contamination during transportation and handling. A key element of a recommended food safety transportation program to minimize cross-contamination of food during handling and distribution is a compatibility matrix.[3]  To ensure product safety where allergen transportation is a concern, food manufacturers and distributors must develop a list of all allergen-containing food and the required packages for that food. These steps will ensure appropriate handling and transportation conditions.

Food transportation by airlines is suspected to be high risk for cross-contamination. Airlines load cargo into subcompartments, which are then loaded onto airplanes, and there is no clear indication that airlines have protocols for loading, unloading and storage of foods to minimize cross-contamination. Trained personnel and clearly defined protocols are essential to ensure food cross-contamination is minimized.  

Conclusions
The safety and defense of the nation’s food supply across the supply chain is paramount, and steps have been taken over many decades to improve the safety of the food supply chain through laws, regulations and technology. FSMA is the latest law passed to ensure the safety and defense of the food supply chain. Its primary focus is prevention across the entire supply chain. Over the last two decades, the nation’s food supply chain has grown significantly through globalization of imported foods to a level of 59 percent of FDA-regulated import products. International food transportation into the U.S. has shifted from trucks and rail to include ships and airplanes. Yet, less than 2 percent of all imported foods are inspected at ports of entry. A more comprehensive and assertive approach is needed to ensure the safety and defense of the U.S. food supply chain during transportation, and the transportation industry is a critical factor.

Little public information is available on the sanitary transportation of food by air; however, it is safe to say that air transportation poses a greater threat to the U.S. food supply than any other transportation mode. FSMA requirements that FDA conduct a study of the transportation of food in the U.S., including air transportation, are significant and can begin to put the spotlight on a rapidly growing food transportation industry, which can only lead to safer and more secured foods within the U.S.          

Food manufacturers and transportation industries must create a powerful partnership and assertively take steps to mitigate traditional and emerging food safety and defense risks during food transportation. Food safety and defense transportation programs (possibly integrated) must be developed and implemented. Ports and border crossings of food entries must be staffed with skilled personnel and equipped with the necessary tools to ensure safe and secured food enters the U.S.

FDA must assertively deliver on the FSMA directive to promulgate regulations to ensure the safety and defense of the food supply chain. As the nation’s food imports continue to grow, FDA should continue its leadership role to assertively establish relationships with other nations to ensure a global supply of safe and healthy food.

Larry Keener, president and chief executive of International Product Safety Consultants Inc., is recognized globally as an expert in food safety, particularly in the area of process validation, and as a process authority. He has extensive expertise in development and implementation of novel and nonthermal processing technologies. He has published and presented more than 75 papers internationally. He is also the vice president and co-chair of the Global Harmonization Initiative. He has served multiple elected positions in the Non-thermal Processing Division for the Institute of Food Technologists (IFT), is an IFT fellow and is on the Editorial Advisory Board of Food Safety Magazine.

Jerry Roberts is the owner and president of Global Quality & Food Safety Consultants, Cedar Knolls, NJ, which specializes in supply chain food safety, quality and crisis management globally. He has held positions in analytical research, quality management, food safety, raw materials and supplier management in pharmaceutical, food and beverage Fortune 500 companies. He is a member of the Food Science and Nutrition Advisory Board, Tuskegee University, AL. He can be reached at arobert1848@gmail.com.

References
1. www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/SanitationTransportation/ucm208199.htm.
2. McColl, D.B. and N.C. Sitthikul. 2006. Safeguarding the food supply — FDA given food transportation authority. Food Issues May/June.
3. Keener, L. 2003. Transportation: The squeaky wheel of the food safety system. Food Safety Magazine Oct/Nov.
4. www.fda.gov.download/Food/GuidanceRegulations/FSMA/UCM351876.pdf.
5. FDCA 21U.S.C. 350e(b).
6. Hardee, K.A. 2012. The industry’s role in our nation’s food safety. For The Defense December.
7. The Food Safety Modernization Act. 2011. 101, et seq., Pub. 1. No. 111-353.
8. The Food Safety Modernization Act. 2011. 111 Pub. 1. No. 111-353 92011.
9. www.ers.usda.gov.
10. www.foodsafetyworkinggroup.gov.
11. www.cdc.gov/foodborneburden/trends-in-foodborne-illness.html.
12. www.medscape.com/features/slideshow/foodborne-outbreaks.
13. Ackerley, N., A. SertKaya and R. Lange. 2010. Food transportation safety: Characterizing risks and controls by use of expert opinion. Food Protection Trends April.
14. www.qualityassurancemag.com/qa0811-supply-chain-safety-transportation.aspx.
15. Federal Register. 2010. 75(83) April 30.
16. Tanner, D.J. and S. Estrada-Flores. 2003. CSIRO-Food Science Australia. Personal correspondence.