Hurricane Devastation Impacts Health Care Supply Chains

The destruction caused by Hurricane Maria in Puerto Rico last month has created major disruptions for the island’s pharmaceutical product and medical device manufacturing facilities. Days of interruption and damage to manufacturing plants are affecting international supply chains for products such as cancer and HIV treatments, immunosuppressants for patients with organ transplants, and small-volume bags of saline, which are necessary for patients who need intravenous solutions.

Puerto Rico is the fifth-largest territory in the world for pharma manufacturing and produces about half of the world’s top-selling patented drugs, according to a 2016 report from Pharma Boardroom. Short-term economic losses are being estimated, while concerns persist about the storm’s long-term effect on employees’ abilities to travel to work, the safety and efficiency of the machinery used and the ability to keep the facilities running on generators. In a statement issued by the Food and Drug Administration (FDA) on Oct. 6, Commissioner Scott Gottlieb detailed plans to help Puerto Rico recover its medical product and manufacturing base, which he said “are a key component of the island’s economic vigor.”

“[..]even the facilities that sustained relatively minor damage are running on generator power. They could be without commercial power for months…Moreover, most of the facilities that we know of, that have resumed production, maintain only partial operations. New shortages could result from these disruptions and shortages that existed before the storms could potentially be extended.”

Citing data from the Bureau of Economic Analysis, Gottlieb said that pharmaceutical products manufactured in Puerto Rico “make up nearly 10% of all drugs consumed by Americans. And that doesn’t even account for medical devices.” He noted that the FDA is keeping a close watch on about 40 critical pharmaceutical and biological drug products which, in the event of a shortage, “could have substantial impact on the public health.”

He added, “In urgent cases, when critical products are at issue, we’ve intervened over the last two weeks to help firms secure fuel to maintain production lines, get clearance to move logistical support into the island or finished goods to their recipients.”

The Washington Post reported that more than four dozen FDA-approved drugmaking facilities are in Puerto Rico, including ones owned by Pfizer Inc., Merck, Eli Lilly, Johnson & Johnson, Bristol-Myers Squibb and Amgen. Baxter International Inc., which the Post cited as being the “dominant player” in the IV market, issued a statement acknowledging the impact of the storm on its operations:

Our sites sustained minimal damage, and we’ve initiated limited production activities in all of our facilities. In addition, we are examining all opportunities to leverage Baxter’s global manufacturing network as we continue efforts to restore operations in Puerto Rico.

As it relates to product supply, in advance of the hurricanes, we implemented our hurricane preparedness plan to help mitigate potential impact. We have also been delivering products to customers in Puerto Rico to help address patient need on the island. And we are continuing to proactively communicate with our customers the actions we are taking to minimize potential disruptions, including closely managing product inventory.

Not all facilities have suffered damage, however. Amgen announced on its site that back-up generators are powering its Puerto Rican site and that, “No product nor in-process inventory has been lost, and … the inventory maintained by the Company and its global distribution network is sufficient to meet patient demand.”

Jones Act Waiver Granted for Puerto Rico

A request to temporarily waive the Jones Act for Puerto Rico that was denied on Monday has been approved. President Donald Trump waived shipping restrictions on Thursday to help speed up fuel and supply deliveries to Puerto Rico, devastated by Hurricane Maria, the White House said.
Maria wiped out power on the island and destroyed infrastructure and cell towers, leading to massive shortages. Even though a waiver had been granted to Texas and Florida after Hurricanes Harvey and Irma, the Department of Homeland Security initially said there was no need to waive the restriction for Puerto Rico, as it would not address the issue of the island’s damaged ports.

The Jones Act, or the Merchant Marine Act of 1920, was initiated almost 100 years ago to keep foreign-flagged vessels from shipping fuel and goods between U.S. ports. The last previous waiver was in December 2012 to allow petroleum products to be delivered for relief assistance after Hurricane Sandy.

Sen. John McCain, R-Ariz., disagreed with the initial decision to deny suspension of the act for Puerto Rico. He wrote to the Department of Homeland Security urging it to allow a waiver and ultimately “a full repeal of this archaic and burdensome act.” Without the waiver, McCain said residents of Puerto Rico would end up paying at least twice as much for food, drinking water and other supplies.

Supporters of the Jones Act, including ship builders, have maintained that it supports American jobs, including jobs in Puerto Rico and keeps shipping routes reliable, according to Reuters. They also contend that the issue in Puerto Rico is distributing shipments across the island once they are delivered.

The temporary waiver was not a surprise, as Puerto Rico Gov. Ricardo Rossello said on Wednesday that he expected the federal government to suspend the Jones Act. He said he had been speaking with members of Congress from both parties who supported an emergency waiver.

Hurricane Flooding Affecting Agricultural Supply Chains

The trillions of gallons of water dumped by Hurricane Harvey on Texas and Louisiana and Hurricane Irma in Florida have created major problems for agricultural producers in these states. The damage is expected to affect supply chains in for businesses including grocery chains, restaurants and livestock ranches as massive rainfall and flooding have interrupted harvesting cycles for crops like wheat, rice, corn and citrus fruits. Short-term economic losses are already being estimated, while concerns persist about the storm’s long-term effect on crops, soil and machinery.

According to the United States Department of Agriculture’s (USDA) Economic Research Service, Louisiana and Texas are respectively the third and fifth-largest rice producers in the United States. While Louisiana planted almost 400,000 acres of rice this year, LSU AgCenter extension rice specialist Dustin Harrell said a recent survey revealed that only about 10,000 acres of first-crop rice remains left for harvest in south Louisiana. “The big unknown at the moment is the ratoon rice in that area,” Harrell said. Ratoon rice is a staple for many companies which grows from the remnants of what has already been harvested. “[It’s] very important economically and it, too, can be lost if the ratoon stubble remains submerged for several days.”

For Texas growers, some experts estimate that a substantial portion of their rice crop is completely unusable. “I estimate 80% of the Texas rice crop (170,000 acres) was cut before the storm hit and the remainder is totally lost. Rain normally makes grain, but this is so much more than rain,” said Dwight Roberts, president and CEO of the U.S. Rice Producers Association located in Houston. “[As of Aug. 29] it’s hard to really even know the condition of harvested rice. We’ve got broken communication, no electricity for some areas, and flooded storage in places. There are so many unknowns.”

In a statement issued by the Food and Drug Administration (FDA) on Sept. 14, commissioner Scott Gottlieb acknowledged that rice harvested following Harvey faces risk of contamination. He said steps are being taken to prevent affected rice from being passed on to consumers or animals that could consume these crops, since broken grain can be used for pet food. He made particular mention of the Texas rice crop, saying that so far the agency had “not issued a ban on rice or any other food crops,” adding that rice grown in normal conditions and rice that has not been exposed to contaminated floodwaters may enter commerce. “Also, rice and other crops that were harvested and stored safely before storms hit should not be considered impacted by these events,” he said. 

The storms affected another key commodity: citrus fruits. The USDA ranks Florida and Texas as the respective first- and third-largest producers of oranges and grapefruits, and the storms took a bite out of their crops as well. Florida’s grapefruit harvest was already estimated to be the lowest in 50 years, with growers and experts expecting near-35% percent losses in the top-producing districts. According to USA Today, specific varieties of oranges like navel and Valencia might see a 25-to-35% loss.

“That puts every grower on the East Coast in red ink” for this year, said Andy Taylor, senior vice president and chief financial officer for the world’s largest grapefruit processer, Vero Beach-based Peace River Citrus Products Inc. “Efforts to salvage some of that and get it processed into juice,” however, are unlikely to save even 10% of the fruit dropped, Taylor added.

During his press conference, Gottlieb said the FDA has dispatched experts to work with state regulators and directly with producers to address questions and concerns about mold and other contaminants. He also recognized the need to get boots on the ground in order to assess the quality of the crops, “or else crops that might be safe—because they were not exposed to contaminated floodwaters—could age past their point of use.”

The FDA distributed resource guides in reaction to the storms. For more general information on evaluating the safety of food and animal food crops exposed to flood waters, visit here. A QA on crops harvested from flooded fields intended for animal food can be found here.

Going Lo-Fi At Sea May Mitigate Cyberrisk

Cyberthreats have become seaborne in recent years, and preventative measures are on the radars of governments and the shipping industry.

GPS and other electronic systems have proven to help ensure safe and accurate navigation, but they have also put digital bullseyes on ship decks. These technology upgrades have unwittingly exposed ships to cyberrisk because their signals are weak enough for remote perpetrators to jam.

When ships and crew members rely solely on GPS systems, they can be at the mercy of a cyberhacker seeking to provide wrong positions (or “spoof”), endanger the crew and their cargo, or hold the crew, cargo or sensitive information for ransom.

These risks are exacerbated by the fact that ships typically do not have automatic backup systems, and younger crew members are increasingly reliant upon the newer electronic navigation tools.

Allianz’s Safety and Shipping Review 2017 highlighted the growing threat of cybercrime in the sector, and noted the increasing level of activity in the last five years. For example, World Fuel Services fell victim to an online bunkering scam in 2014 when it agreed to participate in a tender for a large amount of fuel from what it believed to be the United States Defense Logistics Agency. Cybercriminals collected $18 million from that successful impersonation. In 2016, hundreds of South Korean vessels had to return to their ports after North Korea allegedly jammed their GPS signals.

The report noted that most maritime cyberattacks have been aimed at breaching corporate security, rather than taking control of vessels, but warned that such attacks could occur.

Captain Rahul Khanna, head of marine risk consulting at Allianz Global Corporate & Specialty, noted in the report that more, larger-scale attacks are imminent if the risks are not appropriately addressed. “We can’t put IT security on the backburner,” Khanna said. “Just imagine if hackers were able to take control of a large container ship on a strategically-important route. They could block transits for a long period of time, causing significant economic damage.”

The report also stressed that “crew education and identifying measures to back up and restore systems should be implemented” to reduce cyberrisk.

Looking Back For a Signal Forward
Some companies and governments have heeded the warnings and are identifying these indicators of attack. Preventative measures may lie in a maritime tool that had taken a backseat to the prevalence of GPS—a backup radio technology called Enhanced Long-Range Navigation (eLoran), which was developed in the United States in the mid-1990s. It has continental reach, emits strong signals via a low-frequency and relies on land-based transmitters that reveal a limited number of fixed positions. These once-limiting traits could be the automatic backup systems ships need in the event of jamming or spoofing.

On July 20, 2017, when the Department of Homeland Security Authorization Act (H.R. 2825) passed the floor of the U.S. House of Representatives, eLoran’s importance was stressed. The act includes a section titled “Backup Global Positioning System,” which features provisions for the U.S. Secretary of Transportation to initiate an eLoran system. H.R. 2825 proposes that eLoran be made available as a “reliable…positioning, navigation and timing system,” with the purpose of providing “a complement to, and backup for the Global Positioning System to ensure availability of uncorrupted and nondegraded positioning, navigation and timing signals for military and civilian users.”

Reuters this week reported that South Korea’s Ministry of Oceans and Fisheries is looking to establish the technology in a test form by 2019.

Time will tell if eLoran is the most practical and cost-efficient method to mitigate cyberthreats at sea. It seems if companies want to mitigate maritime cyberrisk now, the first steps would be to look to the technology of the past and turn on the radio.