In the United States, the Transportation Security Administration (TSA) serves as the primary security force designed to protect the freedom of persons and commerce for the national interest. Most air travelers entering, departing, or traveling within the US are used to seeing TSA staffers screening passengers and their luggage at airports in an effort to ensure traveler safety.
However, the role of the TSA is much broader than that, with interests in protecting other modes of transit for the safety of the public as well as the cargo being transported.
Effective on August 1, 2010, the TSA undertook the security screening of 100% of cargo that is to be traveling by air from the United States as mandated by the US congress [1]. The screening process is designed to protect against the placement of explosives within air freight for the purpose of harm.
The TSA considers the risk of terrorist activity greatest in cargo that is transported as part of the vast and fractured network of freight forwarders, 3PL, and 4PL that use the carrying capacity in the belly of passenger aircraft to ship cargo worldwide. There is also risk to all-cargo air networks. The TSA approaches security to both types of networks in accordance with the risks identified in each. Thus, screening and chain of custody requirements for cargo destined on passenger aircraft and allcargo aircraft are different.
The new regulations grant the TSA broad authority. Among other things, they can:
- Inspect any carrier at any time, regardless if they are passenger airlines or cargo airlines, a freight forwarder, or a trucking company that handles cargo destined for air transport to ensure they are in compliance.
- That all carriers must have documentation that they have a security program that addresses the security and chain of custody of cargo, and that all employees involved in the program have been trained and have proof of training.
- A carrier must also have done background checks on staff that have unescorted access to any cargo destined for air transport on a passenger plane.
Of great concern to most companies is that air freight traveling on a passenger airline will require screening on a piece level. Skids, pallets, and the like will require being broken down to the piece level, screened, and reassembled back into their original configuration. Another implication is that cargo will be irradiated during the screening process, a procedure that may have a harmful effect on pharmaceuticals, vaccines, biologicals, biotechnological materials and products.
In addition, the TSA recognized that such a diligent inspection of air freight would likely be a source of delay to any shipper, and therefore created the Certified Cargo Screening Program (CCSP) [2].
The goal of the Certified Cargo Screening Program is to establish the integrity of a shipment through enhanced physical and personnel security standards at Certified Cargo Screening Facilities (CCSFs) and to maintain the integrity of a shipment throughout the supply chain by utilizing stringent chain of custody methods. The CCSP allows industry to pre-screen their cargo, so that once the freight arrives at the airport, it is considered already inspected and able to move easily onto passenger aircraft. The TSA has established facilities around the country that have been analyzed and certified to pre-screen cargo to TSA standards, and inspect that cargo on a piece level before they are configured for transportation. The CCSP also allows companies to screen their own cargo where it is packaged and build their own bulk freight configurations. These must then follow a chain of custody process to secure the screened cargo in transit to the air carrier. The TSA has recognized that GMP processes go a long way toward also meeting security requirements, thus companies with established GMP will generally find that implementing a Certified Cargo Screening Program can be accomplished in a reasonably short time with low cost. This represents a science-based cooperation and recognition of the Food and Drug Administration’s (FDA) Good Manufacturing Practices (GMP) [3].
TSA offers suggestions to industry regarding the choice between either doing one’s own pre-screening of cargo or utilizing an independent certified cargo screening facility. Considerations include:
- Are passenger aircraft frequently used for your shipments?
- Will your shipments be compromised if opened during the screening process?
- Can your product be harmed by a shipping delay?
- Are you already participating in other supply chain programs(CTPAT, cGMP, etc?)[4]
- What are the expenses of screening? Does the amount of shipping done warrant the expense of an in-house screening program?
The TSA also offers guidance that any of the following facility types may apply for the CCSP. Facilities such as manufacturing plants, warehouses, distribution centers, third-party logistics provider locations, and cargo handling facilities, to name a few, are relevant locales for CCSP consideration.
One of the most important concepts that the CCSP commands is the chain of custody standards. The standards for screened cargo use a layered approach including:
- Documentation: Information about the shipment must be documented and included with the shipment so it can be verified at touch points along its travel to the aircraft. The shipping papers, air waybill and bill of lading must be accompanied by certificates and written statements that help to confirm that the chain of custody has been maintained from shipper’s dock, until it is loaded onto an aircraft.
- Security methods: Various methods for confirming the safety of the cargo are prescribed. The purpose is to prevent un-authorized persons from accessing the cargo or for anyone to tamper with it.
- Authentication: Documentation and methods must be authenticated by each party in the chain of custody upon receipt of the cargo at each point in the supply chain, including all the touch points during truck transport, warehouse, and air carrier loading operations. This ensures that the cargo has not been replaced or diverted while enroute.
As a guide for companies who are considering implementing a Certified Cargo Screening Program at their shipping facility, the Parenteral Drug Association’s (PDA) Pharmaceutical Cold Chain Interest Group (PCCIG) has sponsored the PCCIG TSA Cargo Screening Task Force. This multi-company task force has drafted guidance for the pharmaceutical industry that recommends Best Practices for Manufacturers of Temperature Sensitive Products to Comply with TSA Cargo Screening Requirements. This document is currently in the pre-publishing process at PDA.
In cases where a shipper is unable to sufficiently justify implementation of a CCSP at their facility, or is unable to find a convenient third-party screening vendor, a third option is to ship their cargo through an all-cargo airline. The impact of the risk to the traveling public is lower on all-cargo aircraft due to the lack of passengers present on the aircraft. There are detailed security requirements for all-cargo, but they are different than for cargo flown on passenger aircraft, enabling sensitive pharmaceutical shipments to be transported in a way that ensures that the package is safe from the effects of invasive screening technology or breaks in the cold chain.
In the global economy, international regulations do play a part. For example, in the European Union, most shipments are processed through x-ray prior to being loaded on an aircraft. In other countries and regions, specific procedures depend on per country requirements. Additionally, most inbound shipments to the United States go through radiological portal inspections. With the added urgency provided by current events, it is likely that this will also soon approach 100%.
The security benefit of using an all-cargo airline is multiplied when the carrier is an integrator, having all the transportation components controlled by the same company. From the truck used at cargo pick-up to the vehicle delivering the final mile and the aircraft used in between, the supply chain control provided by the integrator remains intact and unbroken in a closed custodial network.
When passenger aircraft are required to move air freight, this is symptomatic of a freight forwarder model, where numerous independent transportation providers (passenger airlines, independent trucking companies, etc.) are utilized to move freight. The model is not designed to provide the security and visibility to the supply chain that the integrator model can provide.
Shippers who utilize air transport can improve their carrier selection decisions by considering these good practices for security and cargo protection.
• Each entity and supply chain partner should be compliant with all C-TPAT security guidelines for end-to-end supply chain security
- Conduct a thorough risk assessment with self-assessment and update it appropriately.
- Container/ULD/Trailer security: maintenance and storage performed by trusted agents, often your own employees, inspections and enroute monitoring.
- Vehicle security: In addition to the personnel with access to cargo, vehicles, equipment, and routes used should also be inspected to ensure they are free from the identified risk characteristics.
- Facility security: operate layered capabilities to control access to facilities that require diligent background screening together with physical controls to prevent unauthorized access.
- Track and Trace enroute.
- Establish procedures for monitoring, reporting and responding to contingency events. Train employees to identify threats and report them to initiate the appropriate response.
- Personnel security: perform diligent background screening of the personnel with access to cargo to include drivers who have access to shipments during pickup, transport, or delivery. Include a company code of conduct and have procedures that guide screening-related terminations.
- Information security: hardware and software physical protection and strong password access controls that are never distributed without an approved need to know.
- Prepare in advance for disaster recovery.
• Whenever possible, ship multiple pallets of a single shipment together on the same aircraft, maintaining integrity of the large shipment, thus increasing security through maintaining positive control of the entire shipment as a coherent unit from door to door. This is more important when passenger networks are utilized. For custodial networks, usually all-cargo, shipping in multiple aircraft possess a lower risk since the likelihood of the separate loads becoming lost or failing to arrive as a unit for customs clearance is less. It is recommended that on passenger aircraft, direct flights should be used whenever possible.
• Utilize track and trace, including timely enroute communication with all parties at the transport unit level (package, box, or pallet). Consider the entire supply/distribution chain when implementing tracking and/or authentication technologies. Collaborate with carrier, storage facility, and/or distributor so that each has the ability to confirm that the product has not been tampered with, diverted, or replaced.
• Have established systems and capabilities for intervention to recover from adverse events – whatever their source. These systems, usually provided by the carrier or forwarder, must be mature enough to respond to meet the risks associated with your product. For example; be able to use near-real-time monitoring data to affect recovery prior to a catastrophic temperature exposure.
• Utilize a monitoring capability for environmental conditions and regulate temperatures around the cargo during transport through multiple modes (air and ground) and during regulatory processes (e.g., customs). Wherever possible or commercially feasible, implement both near-real-time monitoring and environmental protection at pre-identified elevated risk locations and activities along the route.
• If a shipper has not implemented their own CCSP, and an allcargo network is not available, they should use a well-controlled cargo screening facility that is able to confirm the freight is safe for transport without introducing additional significant exposures during the screening process. The screening processes should, with acceptable pre-coordination, be capable of accounting for the sensitivities of various pharmaceutical cargo. Integrators with a closed custodial network are designed for security and provide a viable option for responsible shippers with concerns related to radiation or chemical screening methods applied to their cargo.
These are a few of the many potential areas that shippers and their service provider partners can address in order to efficiently and effectively address common risk elements and promote security in their own organizations by taking advantage of the TSA and US Customs and Border Protection (CBP) programs to secure cargo transport.
Acknowledgements
The author would like to acknowledge the cooperation of Mr. Eric Kinaitis and Mr. Karl Kussow, Fedex Custom Critical, in preparing this article.
References
1. 49 U.S.C. 44901(g) (1) amended to comply with 9/11 Act, specifically Sec. 1602 of the Implementing the Recommendations of the 9/11 Commission Act of 2007 (Pub. L. 110–53, 121 Stat. 266, 478, Aug. 3, 2007) (9/11 Act).
2. Certified Cargo Screening Program (CCSP), www.cbp.gov, and www.secure cargo.org.
3. GMP, United States CFR 21, parts 210 and 211. 4. Customs Trade Partnership Against Terrorism (C-TPAT), http://www. cbp.gov/xp/cgov/trade/cargo_security/ctpat/.
Rafik H. Bishara, Ph.D., is a Technical Advisor, and the Chair of Pharmaceutical Cold Chain Interest Group (PCCIG), Parenteral Drug Association (PDA).