Failure to prescreen air freight could mean added costs, delays
An Aug. 1 deadline looms for screening all U.S. cargo carried in passenger aircraft. If more shippers don't sign on to the government's prescreening program, chaos could ensue.
Mark Solomon joined DC VELOCITY as senior editor in August 2008, and was promoted to his current position on January 1, 2015. He has spent more than 30 years in the transportation, logistics and supply chain management fields as a journalist and public relations professional. From 1989 to 1994, he worked in Washington as a reporter for the Journal of Commerce, covering the aviation and trucking industries, the Department of Transportation, Congress and the U.S. Supreme Court. Prior to that, he worked for Traffic World for seven years in a similar role. From 1994 to 2008, Mr. Solomon ran Media-Based Solutions, a public relations firm based in Atlanta. He graduated in 1978 with a B.A. in journalism from The American University in Washington, D.C.
It is the supply chain equivalent of putting a square peg in a round hole: An industry built on speed of delivery is being forced to stop in mid-process and examine every piece of cargo before it is loaded into the bellies of passenger planes.
Starting Aug. 1, all shipments to be carried on passenger aircraft—3 billion pounds each year moving in U.S. domestic or export commerce—must be screened or physically inspected prior to loading. Compliance with that mandate may prove to be the air-cargo industry's biggest challenge of the post-9/11 era.
Ready or not?
The Transportation Security Administration (TSA), which oversees the program, said it is prepped for show time. "Both we and the industry are ready" for the Aug. 1 deadline, John Sammon, the Department of Homeland Security's assistant administrator, transportation-sector network management, said at a June 30 congressional hearing. "All segments of the cargo community are prepared, and we expect that [the Aug. 1 transition] will happen with little disruption."
But the industry has yet to walk the walk, and the path is littered with mines. On May 1, TSA announced that the industry had met a key milestone by screening three-fourths of all cargo transported on passenger aircraft. That cargo, however, probably represents the air freight equivalent of "low-hanging fruit."
The remaining 25 percent consists of multiple pieces that are shrink-wrapped on pallets or loaded into containers. Those are expected to be difficult to inspect without disrupting flight schedules and deliveries. The problem is that cargo must be examined at the individual piece level before it goes aboard a plane, and no government-approved technology exists to screen goods in palletized or containerized form. Unless the shipments have been screened before they reach the airport, the carrier will have to break down the pallet or container, examine the cargo, and then rebuild the unit load before moving it onto the aircraft.
In an effort to divide up the screening burden and avoid having mountains of unscreened cargo piling up at airports, the government created what it calls the Certified Cargo Screening Program (CCSP). Under this voluntary initiative, participants certified by the government—shippers, freight forwarders, airlines, and third-party facilities—would be authorized to screen cargo in their custody.
To date, there are 440 government-licensed forwarders enrolled in the program, as well as 60 independent screening facilities—informally known as "car washes"—that are certified to screen the cargo but may not deliver the screened cargo to the airlines.
But shipper enrollment has fallen short of expectations. As of mid-June, the TSA said 237 shippers had registered for the program. That's well below the thousands of shippers agency officials had hoped would be participating by that time.
The industry worries that a lack of significant shipper involvement will lead to chaos. Airlines fear they will be inundated with unscreened cargo that they will be obliged to examine. For their part, freight forwarders are concerned their shipper customers will dump the screening burden on them under the premise that it is part of the forwarders' job description.
Those concerns appear to be justified. A recent survey conducted by the Airforwarders Association found that 70 percent of shippers believe that forwarders should assume the responsibility for screening or inspecting shipments. "It has become very clear that the task of screening is going to fall largely on us," said Brandon Fried, the association's executive director.
The Government Accountability Office (GAO) said at the June 30 congressional hearing that shippers' participation would need to increase sixteenfold by Aug. 1 to achieve TSA's goal of having each group bear an equal share of the screening burden. The watchdog agency questioned whether the industry could meet the deadline without the flow of commerce being impeded.
Despite the concerns, the forwarder survey found most respondents "cautiously optimistic" that the industry will be able to manage effectively through the mandate.
Slow on the uptake
Why have shippers been so slow to sign up for CCSP? Some say it's because they have no real inducements to participate. During the June 30 hearing, the GAO noted that shippers have neither regulatory incentives to join the program, which is voluntary, nor economic incentives to do so because the airlines have yet to impose significant screening costs.
Freight forwarder and airline executives call that flawed thinking. As they see it, a shipper's ability to control the screening and inspection of a shipment—rather than having someone else do it for them and risk damaging a fragile, high-value product—should be enough of an economic incentive to enroll in the program.
Shippers would also benefit from prescreening their cargo themselves because it would reduce the risk of having their shipments held up at the airport. Shippers already pay a premium for the speed of air transportation, so they should examine the "opportunity costs" they would incur if their cargo should miss a scheduled flight because the airline couldn't examine it in time, said Ken Konigsmark, senior manager, supply chain & aviation security compliance for the Boeing Co., a large air-freight shipper.
"To the supply chain professional, time is as important as cost," he said.
Art Arway, who heads security for the Americas for Deutsche Post DHL, which owns the world's biggest air forwarder, said shippers are taking a big chance by not joining CCSP and certifying their security processes. "The airlines have said they will accept certified cargo first and then [screen] as they are able," he said. "Shippers will definitely run the risk of missing an airline's cutoff" if their cargo reaches an airport unscreened, he added.
In for a rude awakening
Although some shippers may have hesitated to join CCSP out of concerns about cost, forwarders say such fears are overblown. The cost of participating in the CCSP program varies widely by industry sector, they say, and while forwarders are likely to face significant expense, shippers are apt to get off relatively lightly.
What makes participation so costly for some forwarders is the equipment they have to buy. To accommodate large volumes of cargo, some might end up building stand-alone screening areas, complete with X-ray or explosives trace detection (ETD) machines that identify high-risk cargo. The cost could range from $30,000 to $500,000 per facility, depending on the quantity and sophistication of the equipment, according to Fried of the Airforwarders Association.
At the June 30 hearings, Mike Middleton, executive vice president of Secure Global Logistics, a Houston-based integrated logistics company, told lawmakers that his firm had spent about $400,000 on equipment, staff training, and implementing security measures to comply with the inspection mandate. And the tab can run much higher. Arway said Deutsche Post DHL spent millions of dollars in 2009 to purchase ETD machines after deciding that X-ray equipment produced too many false positives.
Shippers, on the other hand, may not have to go to such lengths. Many shippers already examine their shipments as part of their daily manufacturing processes and have security equipment installed and inspection procedures in place. In some cases, joining the CCSP could be as simple and inexpensive as erecting a fence around an open area and having it designated a certified screening facility, according to Fried.
"Shippers face very little cost in getting certified. The challenge is that they're not registering," he said.
That could be a big mistake. Shippers that haven't registered for the program or made other arrangements to have their freight prescreened could be in for a rude awakening next month, when new fees and requirements kick in. For example, American Airlines on Aug. 1 will double its security charges for goods it is required to screen. It will also add two hours to flight cutoff times for unscreened cargo, meaning the goods must hit American's docks six hours before the flight's scheduled departure, according to Dave Brooks, head of the airline's cargo unit. However, for cargo that has been screened or inspected before it reaches the airport, the airline will keep the four-hour cutoff times and waive the additional screening fees, he said.
Lest anyone think that American's policy is an anomaly, Arway offered a warning. Virtually all U.S. airlines will follow the carrier's lead—if they haven't already, he said.
A tangled web of cargo security rules
The story of air-cargo security is, in reality, two stories.
The first has largely been written. On Aug. 1, all air cargo scheduled to fly from any U.S. airport in the lower decks, or "bellies," of passenger planes must be screened or inspected before being allowed on board. The law covers all domestic cargo as well as export shipments flown by U.S. or foreign-flag carriers.
The second has yet to play itself out. It involves the screening or inspection of cargoes departing foreign airports bound for the United States. It is a complex, tangled affair involving issues of national sovereignty and paranoia. And it may take several years to write.
The 2007 law requiring the screening or inspection of U.S. belly cargo also set an Aug. 1, 2010, deadline for the examination of all air-freighted goods loaded on passenger planes at foreign airports. However, meeting that deadline would prove to be impossible, due to the difficulty in harmonizing multiple security regimes.
Several months ago, administration officials discussed the possibility of setting a Dec. 31, 2010, deadline to meet the mandate. That, too, was quickly withdrawn. At a congressional hearing on June 30, the Transportation Security Administration (TSA), which oversees the cargo security program, said it would take about three years to achieve 100-percent examination of inbound belly cargo. Currently, about 62 percent of all inbound cargo is being inspected before loading, according to TSA estimates.
For U.S. and foreign governments, the first order of business may be to resolve the "Catch 22" that currently exists in the global security net. Many of the United States' trading partners have supply chain security programs in place. However, they are unwilling to share information about those programs with other countries—including the United States—because of their sensitive nature. The TSA has said that unless it gains access to the details of foreign governments' screening provisions, it cannot determine if they meet U.S. requirements, and thus cannot recognize them.
The back-and-forth between governments means that the international air supply chain may find itself dealing with multiple security programs for some time to come. For example, in the case of cargo flying from Germany to the United States., the goods may be subject to two screening programs, one complying with German requirements, the other meeting the U.S. standards.
TSA and its umbrella agency, the Department of Homeland Security (DHS), said they are working with international regulatory bodies like the International Civil Aviation Organization (ICAO) as well as individual governments to develop harmonized standards for cargo security. Through cross-sharing of information, DHS and TSA hope to identify nations with security programs with requirements that are similar to the United States'.
TSA also said it is exploring with the Bureau of U.S. Customs and Border Protection (CBP) the possibility of using CBP's Automated Targeting System to collect information on inbound cargo before the plane departs the origin airport. TSA said the program will allow it to perform what it called "baseline threshold targeting," enabling it to better identify high-risk cargo that should be subjected to further screening.
What was your biggest headache during the depth of the Covid-19 pandemic? For many forklift fleet managers, it was the constant churn among lift truck operators. Six-month turnover of 100% with daily absentee rates of 30% or more was not unheard of. Those numbers have since declined, but they remain high. In our May 2024 article “Playing it safe in a high-turnover environment,” forklift suppliers cited annual turnover in their customers’ fleets of 35%, 45%, or higher.
The consequences of high turnover can be serious. Safety could be compromised when operators don’t stay on the job long enough to fully understand their responsibilities, the equipment they’re using, or the operations of the facilities where they work. Supervisors and managers may have to devote more time to hiring, training, and ensuring shifts are covered, leaving less time for their other responsibilities, says Jared Green, director of global sales for automation and emerging technology at Crown Equipment Corp. Facilities may have to make do with suboptimal processes when fleets are shorthanded, he adds.
Clearly, it’s in everyone’s interest to improve retention. But how? Here are 10 recommendations from forklift providers and an end-user on ways to keep operators wanting to work for you.
1. Pay them fairly. According to a blog post titled “Fair Pay for Forklift Operators: What Should They Earn?” by the online equipment vendor Forklift Inventory, the average hourly wage for operators in the U.S. is about $20, and many make less than that. It’s not surprising, then, that some forklift operators would jump ship for a slight boost in hourly pay. Even if the hourly rate is comparatively high, if it’s the same for all operators, then it may not satisfy everyone. Sources we consulted suggested that operators will feel they are being fairly compensated and will be less likely to leave if their pay reflects such factors as experience, seniority, work environment (hot/cold/outdoor), task difficulty, and the local cost of living.
Benefits and other perks can also help to attract and retain operators. Scott Alexander, vice president of sales and marketing for LiftOne, an authorized dealer of forklifts from Hyster Co. and Yale Lift Truck Technologies, says that in his experience, “customers who spend a little more and put more effort and investment into total compensation—while also supporting facets of the operator experience like ergonomics, safety, positive reinforcement, and training—generally see fewer operators leaving for a small change in pay.” Considering the physical risks inherent in the job, the most important benefits to an operator may be health insurance, disability policies, and support services like employee assistance programs.
2. Give them the right equipment. Inappropriate equipment undermines operators’ ability to work safely and efficiently, leading to frustration and a lack of confidence. That’s why it’s important that the equipment is specifically designed to “do the job you’re asking the operator to do,” says Ron Flanary, senior vice president of national operations for Southern Glazer’s Wine & Spirits, the largest distributor of beverage alcohol in the United States.
Southern Glazer’s is careful to deploy the right mix of equipment in each of its 40-plus distribution centers. The DCs use forklifts of various types, such as sit-down counterbalanced trucks, order pickers, reach trucks, and turret trucks. Most are electric, but some propane-powered forklifts are also in service. Because the important thing is to deploy the best truck for each application, Southern Glazer’s runs equipment from multiple providers.
3. Keep them comfortable. Operators may be subjected to physical stresses like pressure on the spine and legs, exposure to vibration and noise, hot or cold temperatures, and muscle strain. Providing comfortable equipment with ergonomic features like suspension seats, easy-to-reach controls, and fatigue-reducing flooring, together with good ventilation, comfortable temperatures, and any necessary protective gear, can enhance operators’ health and well-being and, in turn, their willingness to keep showing up for work. Mike Hance, technology center manager at Equipment Depot, which represents Cat lift trucks, Mitsubishi forklift trucks, and Jungheinrich in 25 states, knows of one operator who had planned to retire—until he started using a new Jungheinrich forklift with advanced ergonomic features. His back stopped hurting, and he felt so much better after his shifts, Hance says, that he stayed on and worked for a couple more years.
4. Focus on the “three Cs.” Operators who are satisfied in their jobs typically possess what Keith Ingels, lean management manager for The Raymond Corp., calls the “three Cs”: **ital{confidence} in their understanding and skills, the **ital{capability} to do the job safely and efficiently, and **ital{clarity} on what is expected of them. Without all three, he says, operators will become frustrated and more likely to leave.
The main way to instill confidence and develop operators’ capabilities is through an effective, well-executed training program. In Ingels’ experience, confidence, in particular, gets a boost when trainees practice in a setting that’s similar to the actual operating environment. He tells of one customer that has three DCs with the same layout, storage setup, and training program—yet one of them had a third less operator turnover than the others. It turned out that in two of the facilities, new operators practiced driving with loads around cones and barrels. In the DC with the lower turnover rate, new operators practiced, also with loads, but in a training area with a short, unbolted rack and other features that were similar to the location where they’d be working. Operators in that DC told Ingels’ team that getting a realistic feel for what their work would actually be like built up their confidence from the start and made for a smooth transition to the floor.
As for clarity, no one can meet expectations if they don’t know what they are. To ensure that forklift operators at Southern Glazer’s understand expectations as well as “what success looks like,” the facilities hold pre-shift meetings where managers explain the workload and set expectations for the shift, Flanary says. Southern Glazer’s also tries to notify operators as early as possible if overtime will be necessary, so they and their families can plan ahead. This policy also lets operators who are unable to work overtime notify their supervisors early enough that they can line up a substitute.
5. Don’t put roadblocks in their way.Operators get frustrated when conditions slow them down—especially when their compensation is based on productivity. For example, nobody will be happy if product has been dropped in aisles or travel areas, forcing operators to follow a longer, less-efficient travel path or get off their trucks to remove the obstacle. Poorly planned traffic flow that causes congestion and delays will also create dissatisfaction.
Similarly, good housekeeping practices, such as removing packaging and other waste, and generally keeping a facility neat, clean, and well organized, has a beneficial impact on operator retention because it demonstrates pride in the workplace and respect for the people who work there.
6. Show you care about their safety. Operators are more likely to feel valued and respected in facilities that consistently demonstrate that employee safety is a top priority. That describes the culture in the Southern Glazer’s DCs, according to Flanary, who’s convinced that making safety “a high—and highly visible”—priority at both the corporate and local levels contributes to the company’s low operator turnover rates. Holding weekly safety meetings at every DC and responding to safety issues right away also demonstrate a sustained commitment to employees’ well-being.
Many operators appreciate being involved in workplace safety initiatives. Such efforts can be sensitive, however. For instance, it’s common to ask operators to report any unsafe behaviors they observe, but they may be reluctant to do so out of fear of damaging personal relationships or getting a co-worker in trouble. Still, operators often will be more receptive to guidance from their peers than to feedback from their managers. For that reason, some companies have had great success with teaching forklift operators how to collegially approach peers about safety issues they’ve personally observed and then coach their co-workers on proper procedures.
7. Recognize and reward their achievements. Celebrating employees’ milestones, such as years of service and number of hours without an incident, can boost performance and encourage longevity. Monetary incentives for achieving productivity or safety goals are especially effective because the longer an operator stays, the more opportunities there are for extra compensation. Group recognitions—for example, programs in which individuals’ safety records count toward a team goal with a reward for the entire team—encourage co-workers to support each other’s efforts. Other ways to recognize operators’ accomplishments and contributions include publicity through company newsletters, social media, and the local press; awards like plaques or gifts; and in-person celebrations.
8. Give feedback appropriately.It’s not easy for anyone to accept criticism, so the way you talk to operators about errors and how to correct them has a big impact on their attitude. Experts recommend framing such feedback in terms of benefits: The purpose is not to criticize but rather to help operators improve their skills and productivity while keeping themselves and their co-workers safe.
Different age groups want different levels of feedback. Ingels says younger generations “have grown up with computers and online chat and texts, so they like much more frequent and ‘small bite’ feedback” than older generations do. Younger operators also may enjoy getting feedback through video game-style applications.
Southern Glazer’s is one company that has taken that route. Its new warehouse management system includes a “gamification” option that lets forklift operators test themselves against company-set targets, their co-workers, or their own “personal best” performance. Flanary notes that users must meet their goals safely—they’ll be penalized every time they fail to follow prescribed safety practices.
“When done right, gamification is a very, very effective tool for motivating operators,” he says. “In my opinion, we’re moving away from engineered labor standards and stopwatches. In the future, it will be more about [giving] operators tools that help us set expectations and motivate them to be efficient.”
Other technologies that provide feedback include wireless fleet and operator management tools that collect an array of data, then create reports that measure performance and identify issues, such as a pattern of repeated mistakes. Because these reports are based on data, they take the emotion out of negative feedback, Crown Equipment’s Green says. He adds, however, that the most effective approach in his experience is a combination of data-driven feedback and personal coaching.
Technologies like object detection, operator-presence sensors, and operator-assist systems provide feedback in real time by responding to operators’ actions or to the surrounding environment. For example, operator-assist systems like Hyster Reaction and Yale Reliant, to name just two of the options currently on the market, automatically adjust a truck’s performance if the system senses activity that exceeds certain established thresholds. Such systems’ capabilities vary depending on the OEM and the truck model; examples include controlling a mast’s tilt angle and lift/lower speed and adjusting a forklift’s travel speed, acceleration, or deceleration to maintain stability and help prevent tipping. In addition to feeling the change in the truck’s performance, operators receive a visual alert indicating what is happening and why.
9. Ask for theirrecommendations. Operators want to be heard and to know that their employers care about what they think. Raymond’s Ingels suggests having informal conversations, asking questions like: What’s difficult about your job? Is the traffic flow efficient and safe for you? What changes would you like to see?
At a beverage company that LiftOne’s Alexander works with, team leads conduct end-of-shift debriefs, giving operators a chance to discuss what’s working and what’s not. He reports that attitudes and engagement seemed to improve under this approach, which solicits operators’ opinions on what the facility should start doing, what it should stop doing, and what it should continue doing.
But it’s not enough to simply listen; you also have to act on the operators’ recommendations. That extra step paid off for one of Green’s customers, which was planning to deploy new technologies that threatened to create some challenges for forklift operators. With support from Crown Equipment’s experts, a team of operators and their supervisor investigated how the new technologies and some planned layout changes would affect their productivity, then offered recommendations for improvement. Based on the group’s feedback, facility managers made adjustments to both the layout and the technology rollout that made it easier for the operators to do their jobs.
10. Forge a personal connection. In a large facility with multiple shifts, operators may feel overlooked and unrecognized. Tony Parsons, regional operator training manager at forklift dealer Wolter Inc., which represents Linde, Doosan Bobcat, and other brands across the Midwest, tells of one operator working in a large DC with high operator turnover. After three months, the operator said, he still did not know who the warehouse operations manager was—he had only met his direct supervisor. Parsons contrasts that with another, smaller customer, where the owner walks around every payday and personally hands each employee a paper confirmation of their direct deposit. He addresses them by name and often takes a few minutes to chat with them—one reason that facility experiences less than 10% annual turnover among its forklift operators.
Another way to provide a personal connection is through a mentoring program, where experienced operators are paired with inexperienced co-workers. “Often, newer operators don’t want to ask questions in front of a manager because they’re worried it will make them look bad,” Ingels says. “With a peer, they can be far more open because that gives them a ‘safe zone’ to have conversations and ask questions.”
THE BROAD VIEW
Flanary believes that while many factors contribute to operator retention, it’s important for managers to also consider a broader perspective. “A big part of our role as leaders is to create an environment that’s safe and productive, where [operators] can be effective,” he says.
The competition for quality operators is intense, and paying good wages and offering good benefits certainly helps get them in the door. But, he stresses, “if you’re going to keep them, they have to know that what they do has value. That’s a basic human need—they need to know they’re not just a cog in the wheel.” What’s more, he adds, “you can’t fake it. It has to be real and genuine. That’s not easy, but in our company, it is real and important, and because of that, we have a team that loves what they do.”
Imports at the nation’s major container ports should continue at elevated levels this month despite the strike, the groups said in their Global Port Tracker report.
To be sure, the strike wasn’t without impacts. NRF found that retailers who brought in cargo early or shifted delivery to the West Coast face added warehousing and transportation costs. But the overall effect of the three-day work stoppage on national economic trends will be fairly muted.
“It was a huge relief for retailers, their customers and the nation’s economy that the strike was short lived,” NRF Vice President for Supply Chain and Customs Policy Jonathan Gold said in a release. “It will take the affected ports a couple of weeks to recover, but we can rest assured that all ports across the country will be working hard to meet demand, and no impact on the holiday shopping season is expected.”
Looking at next steps, NRF said the focus now is on bringing the International Longshoremen’s Association (ILA)—the union representing some 45,000 workers—and the United States Maritime Alliance Ltd. (USMX) back to the bargaining table. “The priority now is for both parties to negotiate in good faith and reach a long-term contract before the short-term extension ends in mid-January. We don’t want to face a disruption like this all over again,” Gold said.
By the numbers, the report forecasts that U.S. ports covered by Global Port Tracker will handle 2.12 million twenty-foot equivalent units (TEU) for October, which would be an increase of 3.1% year over year. That is slightly higher than the 2.08 million TEU forecast for October a month ago, and the strike did not appear to affect national totals.
In comparison, the August number was 2.34 million TEU, up 19.3% year over year. The September forecast 2.29 million TEU, up 12.9% year over year, November is forecast at 1.91 million TEU, up 0.9% year over year, and December at 1.88 million TEU, up 0.2%. For the year, that would bring 2024 to 24.9 million TEU, up 12.1% from 2023. The import numbers come as NRF is forecasting that 2024 retail sales – excluding automobile dealers, gasoline stations and restaurants to focus on core retail – will grow between 2.5% and 3.5% over 2023.
Global Port Tracker, which is produced for NRF by Hackett Associates, provides historical data and forecasts for the U.S. ports of Los Angeles/Long Beach, Oakland, Seattle and Tacoma on the West Coast; New York/New Jersey, Port of Virginia, Charleston, Savannah, Port Everglades, Miami and Jacksonville on the East Coast, and Houston on the Gulf Coast.
The features are based on SAP’s “generative AI copilot” platform called Joule, launched about a year ago. The latest upgrades to that product add collaborative AI agents that truly speak the language of business, expand Joule’s capabilities to support 80% of SAP’s most-used business tasks, and embed Joule more deeply within the company’s portfolio.
Specifically, collaborative multi-agent systems can now deploy specialized AI agents to tackle specific tasks and enable them to collaborate on intricate business workflows, adapting their strategies to meet shared objectives. SAP is infusing Joule with multiple collaborative AI agents that will combine their unique expertise across business functions to collaboratively accomplish complex workflows. These AI agents enhance productivity by breaking down silos and freeing workers to concentrate on areas where human ingenuity thrives.
And Walldorf, Germany-based SAP also said it had met its goal to train workers how to use those powerful new AI tools by upskilling 2 million people worldwide by 2025. That approach has lowered the world’s digital skills gap through role-based certifications, free training materials, and hands-on opportunities for developers. To continue that program, SAP says it will continue to expand its portfolio of AI-related learning opportunities, including courses on generative AI, AI ethics, and the company’s advanced AI tools and platforms.
For players in the drug distribution business, the countdown is on. In less than two months, every business involved in the pharmaceutical supply chain must be fully compliant with the Drug Supply Chain Security Act (DSCSA)—a 2013 law containing strict traceability requirements for the distribution of certain prescription drugs. Over the past decade, the DSCSA has been implemented in phases, but now the clock is running out. The law takes full effect on Nov. 27, barring any further adjustments or delays.
Among other measures, the DSCSA requires drug manufacturers to affix a unique product identifier, essentially a barcode, to every package so it can be tracked and traced during its journey through the supply chain. To thwart drug counterfeiters, the new law further requires wholesalers and drug dispensers to verify the validity of products they handle to assure they are genuine.
Is the pharmaceutical industry ready for all this? To find out, we spoke with Elizabeth Gallenagh, general counsel and senior vice president, supply chain integrity at the Healthcare Distribution Alliance(HDA), a national organization that represents U.S. health-care distributors. In addition to serving as HDA’s chief legal officer, Gallenagh is also the group’s primary expert on prescription drug traceability, supply chain safety and integrity, distributor licensure, and tax issues. She is a graduate of the George Mason University School of Law and George Washington University.
Gallenagh recently spoke with David Maloney, **{DC Velocity’}s group editorial director, about the enactment of DSCSA for an episode of the “Logistics Matters” podcast.
Q: First of all, can you tell us a little bit about the Healthcare Distribution Alliance?
A: Yes, the Healthcare Distribution Alliance, or HDA, is a national trade organization representing pharmaceutical distributors, also known as wholesalers. We have about 40 members that purchase drugs from manufacturers. They store the products in their warehouses and then fill orders for pharmacy customers throughout the country.
Q: The Drug Supply Chain Security Act will go into final effect in November. What’s the intent of the legislation?
A: The Drug Supply Chain Security Act—or as we call it, the DSCSA—is a law that was enacted in 2013. Its intent was to put together a national framework for drug supply chain security, essentially to enable a tighter, safer, more secure supply chain for the domestic U.S. market.
It involves all trading partners and ultimately will create an interoperable system that enables investigations by tracing a product with every transaction or sale of that product throughout the supply chain, down to the provider level.
Q: What are the law’s major requirements?
A: The law was actually phased in over a period of about 10 years. Many of the major requirements went into effect throughout that initial 10-year period—things like requirements mandating that manufacturers serialize their products and stipulating that trading partners only do business with other authorized trading partners. Authorized trading partners are defined as those that are duly licensed or registered with the Food and Drug Administration (FDA) or licensed by the states.
It also requires tracking of product with every transaction. A transaction is defined as a sale of the product, essentially from one authorized trading partner to another. And as we progress into the final phase, the law will also require serialized data, basically transaction information at the serial-number level that moves with the product through every transaction throughout the supply chain.
Q: You’ve said that the industry has had years to ramp up to comply with the law. Are our pharmaceutical supply chains ready for the final phase?
A: I think that’s still the $64,000 question. I can speak for our members, who have been doing everything in their power to get their own systems and processes ready to receive the serialized products and data, and then to transmit that serialized data with the product to their pharmacy customers.
That said, there are still some gaps in the system. We have been in a “stabilization” period that expires on Nov. 27. During this period, everybody has been testing and bringing product and data transactions live into production. I will tell you that many are ready, but there are still bugs that are being worked out as we race toward November.
I should also note that on Aug. 19, the HDA sent a letter to the FDA stating that “despite a concerted effort, some in the supply chain appear to remain short of reaching our joint goal of complete implementation.” In its letter, the group urged the FDA to “take immediate action to forestall potential disruptions to the drug supply chain and patient care that could stem from incomplete implementation of the enhanced drug distribution security (EDDS) requirements” and asked the agency to adopt “a phased, stepwise approach” to implementing the requirements in order to avoid disruptions to the movement of drugs through the supply chain.
Q: Will penalties be imposed on companies that fail to meet the deadline?
A: There will be penalties. But it’s important to note that the DSCSA is really about setting up the framework for tracking and tracing products—so that a manufacturer will only be permitted to sell its product downstream if it is a serialized product and the manufacturer can transmit the corresponding serialized data with the product. And then a distributor can only receive that product and purchase it if it has the corresponding data.
Q: Of course, this is only possible if you have the right technology in place to monitor and track drugs as they move through the supply chain. What kind of technologies are being deployed to make this possible?
A: The key to all of this is the barcode, which is mandated under the law in terms of the way that product is serialized. Everybody in the supply chain has to have the capability to utilize the barcode. If you’re a manufacturer, you have to incorporate that 2-D barcode with the serialized data into that product’s label. And that should already be in place under the first phases of the law.
Downstream partners will have to be able to read that barcode and import that data into their systems. This also enables verification of the product at the unit level.
In addition, we’re also deploying what we call EPCIS [a global data-sharing standard developed by the global standards organization GS1 that allows businesses to capture and share information about the movement and status of goods]. That is the backbone for getting all of this serialized data flowing to all of the requisite trading partners throughout the supply chain.
Q: As we learned during the push to distribute Covid-19 vaccines, a good number of pharmaceutical products must be temperature- or humidity-controlled. Will these new regulations help ensure that they’re properly handled as they move through the supply chain?
A: The DSCSA doesn’t speak specifically to temperature controls. However, there are other parts of the law [the overall Drug Quality and Security Act, which includes the DSCSA as well as the Compounding Quality Act] that do require those controls to be in place. That said, the DSCSA does require affected parties to do business with authorized trading partners. And in order to be an authorized trading partner, you have to adhere to temperature controls and safety rules for products, product handling, etc.
Q: Many of our pharmaceuticals are manufactured overseas, in China and India, for example. Do foreign manufacturers have to comply with DSCSA requirements?
A: If a foreign entity is producing product for use in the U.S. domestic market, the product has to be approved by the FDA. And it also has to meet DSCSA requirements.
Q: We hear a lot about counterfeit products infiltrating the drug supply chain. Will these new regulations reduce the number of counterfeits in the market?
A: We certainly hope so. All of this really started [as an effort to combat the rise in] counterfeit products and transactions back in the early 2000s. Obviously, the idea is to deter counterfeiters from infiltrating the U.S. drug supply chain. But really, what the law does is provide tools for the FDA and regulatory agencies to investigate suspect and illegitimate product, as well as tools that will enable the trading partners that are involved in the transactions to identify suspect product, flag it, quarantine it, investigate it, and deem it OK or deem it illegitimate based on their investigations.
So it really gives some investigatory and prosecutorial tools to the agencies. And it puts a process in place with the technology and serialization to pinpoint whether something is good product through verification with the manufacturer or through tracing of the product data that has accompanied the product throughout its journey through the supply chain.
Q: Drug prices in the U.S. are notoriously high compared with prices in many other countries. Will these new requirements add to the overall cost of supplying medication?
A: I haven’t seen any data that alludes to DSCSA compliance adding to drug costs. It’s an industry that’s built around efficiency, and so my sense is that [pharma industry players] probably have also built in plans over the last decade to absorb some of those costs. That said, the law also established a national tracking and tracing framework, where before we had a 50-state patchwork of regulations. So there would likely be some efficiencies gained from following a single, nationwide protocol, even though it’s a huge undertaking, versus doing it 50 different ways across the country.
Q: Now that DSCSA is nearing full implementation, how are your members feeling about the process?
A: Our members have been committed to this from the very beginning. We were very involved in negotiating on the legislation and pushing these concepts. We really have been working toward implementation from the get-go and throughout this entire 11-year period; we very much want to get to full implementation. But in the beginning, there may be some hiccups. We may hit a few bumps along the way.
A colleague of mine used to say, “We don’t know what we don’t know.” And I think that at each phase as we deploy new technologies and new processes, we will learn new ways to do things more efficiently. So we’re pushing hard toward November, and we are very hopeful.
Autonomous inventory management system provider Corvus Robotics is delivering drone technology for lights-out warehouse environments with the newest version of its Corvus One drone system, announced today.
The update is supported by an $18 million funding round led by S2G Ventures and Spero Adventures.
“Corvus Robotics fits our mission to invest in companies that truly transform the way business is conducted,” Marc Tarpenning, co-founder of Tesla and partner at Spero Ventures, said in a press release Tuesday. “Other than a landing pad, its drone-powered system requires no infrastructure, is quick and easy to deploy, and cost-effective to manage. It literally merges with the existing warehouse environment.”
Corvus Robotics’ drone-based inventory management system uses computer vision and generative AI to understand its environment, flying autonomously in both very narrow aisles—a minimum width of 50 inches—and in very wide aisles. It uses obstacle detection to operate safely in warehouses and features an advanced barcode scanning system that can read any barcode symbology in any orientation placed anywhere on the front of cartons or pallets, according to the company.
The lights-out feature is already in use at customer locations.
“Being able to run inventory checks 24/7 without operator assistance has been a game changer,” Austin Feagins, senior director of solutions at third-party logistics services (3PL) provider Staci Americas, said in the release. “The lights-out capability in the Corvus One system allows our inventory teams to correct discrepancies off-shift and pre-shift before production starts each day, limiting fulfillment delays and production impacts.”