About Justin Smulison

Justin Smulison is the business content writer at RIMS.

New Voluntary Hot Air Balloon Safety Program Announced

The Balloon Federation of America (BFA) has instituted new safety accreditation for companies and pilots. The Envelope of Safety program was the result of the Federal Aviation Administration’s (FAA) year-long call to action from the commercial hot air balloon industry in response to last year’s mid-air accident in Lockhart, Texas which caused 16 fatalities.

The Envelope of Safety aims to enhance the standards for commercial balloon operators and reduce the risk of injury or death leading up to and during a flight. The program is voluntary and aims to reassure confidence by giving consumers the ability to select a ride company or pilot meeting the new flight worthiness certification. The Envelope of Safety’s missions it to insure that companies and pilots carrying four or more passengers:

  • Are commercially certificated for 18 months
  • Accumulate a specified amount of flight experience
  • Hold a second-class medical certificate from the FAA

Additionally, pilots are required to pass a drug and alcohol background check, attend a BFA-sanctioned safety seminar in the 12 months before takeoff and be enrolled in the FAA WINGS pilot proficiency program.

The program features three levels of safety accreditation—Silver, Gold and Platinum—which detail stringent safety requirements for companies of all sizes. That criteria includes meeting pilot requirements, holding valid aircraft and commercial vehicle insurance and hosting a forum for passengers to rate the company.

While the FAA is not connected to the new program in an official capacity, it did applaud the BFA’s announcement on its own website and promoted it via social media. Following last year’s deadly incident in Texas, the agency was criticized for having previously rejected the National Transportation Safety Board’s (NTSB) recommendations for stricter safety oversight regarding commercial hot air balloon travel. That accident, in which a Heart Of Texas Hot Air Balloon Ride vessel crossed power lines, caught fire and plummeted 100 feet to the ground, is considered the worst of its kind in U.S. history.

The NTSB held a board meeting to examine the cause of the July 30, 2016 crash and found the accident attributable to the Heart Of Texas pilot’s pattern of poor decision making, which led to “the initial launch, continuing the flight in fog and above clouds and to dissent near clouds that decreased the pilot’s ability to see and avoid obstacles.” The board believed the operator’s bad judgment may have been exacerbated by the many prescription drugs found in his blood, according to a toxicology report. The board stressed, however, that it did not believe the medications impaired the pilot’s ability to operate the balloon.

The NTSB recommended that the FAA review its policies based on the findings and, in particular, close a loophole that exempts balloon operators from holding the same second-class medical certification that other aviators must possess.

“Today’s recommendations, if acted upon, will bring the safety standards and oversight of commercial passenger carrying balloon operators closer to those that apply to [general aviation] pilots,” said NTSB Chairman Robert L. Sumwalt.

According to the FAA, 413 people died in 219 general aviation accidents in 2016, with inflight loss of control—mainly stalls—accounting for the largest number of fatal accidents.

Visit the BFA’s site or the FAA’s endorsement for more information regarding the Envelope of Safety.

N. Calif. Wildfires Continue Widespread Destruction


The National Interagency Fire Center (NIFC) increased the National Preparedness Level to 3 today due to wildfire activity in eight Northern California counties, including Napa, Sonoma and Mendocino, where evacuations, road, trail and area closures are in effect. Since their start on the night of Oct. 8, the wildfires in California’s wine country have caused 23 deaths and forced more than 20,000 to evacuate, including the entire city of Calistoga. Additionally, hundreds of residents are missing.

Gov. Jerry Brown declared a state of emergency in Napa, Sonoma and Yuba counties on Oct. 9 and the Presidential Major Disaster Declaration was approved by President Trump on Oct. 10 to support state and local responses. The Governor’s Office of Emergency Services also activated the State Operations Center in Mather, California to its highest level.

The 22 uncontained large wildfires have consumed 170,000 acres in California and destroyed nearly 3,500 commercial and residential properties, many of which were in north Santa Rosa. One major difficulty responders are facing is that several fires have merged into complexes—where two or more individual incidents are located in the same general area—with each complex including an average of five fires.

Causes of the fires have not been determined, although downed power lines due to strong winds were reported on Sunday night, about the time of the first fires. Pacific Gas & Electric Company (PG&E) said its meteorologists measured the inciting gusts at between 50 and 75 miles per hour on Sunday night, which contributed to nearly 20 North Bay fires and “aided the fires in the Northern parts of the energy company’s service area…and damaged PG&E’s electrical system in some locations.”

The National Weather Service issued a wind advisory for North Bay Hills today. Heavy winds have consistently hindered efforts to control and contain the fires, and have been clocked at 20 to 30 miles per hour in the area, with some gusts expected to reach 50 miles per hour. According to CoreLogic’s hazard risk analysis, more than 170,000 homes in Napa and Santa Rosa alone are at some level of structural risk from the fires, with about 6% at significant risk.

Utilities have been affected, as well. Officials told SFGate that water systems in isolated areas of Fountaingrove and Oakmont in  Sonoma County have been “compromised,” prompting Santa Rosa police to advise that residents boil tap water used for cooking or drinking. Poor water quality has also become an issue in Napa County.

As reported in Risk Management magazine earlier this month, wildfires in the United States from Jan 1. to Sept. 15 had already burned 8.3 million acres, far exceeding the 10-year average. As of September, the Forest Service and Interior Department had spent more than $2 billion fighting fires this year—making 2017 the most expensive wildfire season on record.

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.”

Lawsuits Question Arkema Emergency Preparedness Plan

Last week officials in Harris County, Texas were granted permission to file a lawsuit against international chemical company, Arkema, Inc., in attempt to recover the costs of responding to the crisis at the company’s plant in Crosby during Hurricane Harvey in August into September. The County has asked a court to review the plant’s environmental practices and disaster preparedness plan and to determine how, if at all, it was updated to reflect the projections of 50-plus inches of rain in the days leading up to Harvey’s landfall.

The New York Times reported that in its risk management plan to the federal government, Arkema indicated that floods and hurricanes, as well as power failure and loss of cooling, were threats to its Crosby chemical plant. In its filing with the government, however, Arkema did not provide contingency plans to address those concerns, the Times said.

As previously reported, several feet of floodwaters caused a power outage which subsequently prevented Arkema plant staff from ensuring that nearly 500,000 tons of organic peroxides were kept cooled and stable. The chemicals eventually overheated and caused a series of explosions which started in late August into the first week of September. This led to a mandatory 1.5-mile evacuation of the area, affecting about 300 homes and many nearby businesses.

Local media reported that Harris County Attorney Vince Ryan is expected to file the lawsuit this week. “The company’s lack of preparedness caused a crisis on top of this horrific storm,” Ryan said in a statement. “Dozens of first responders were required by this emergency caused by Arkema when their services were desperately needed elsewhere.”

According to the County’s statement:

Investigations conducted by the Harris County Pollution Control Services and the Harris County Fire Marshal’s Office uncovered serious violations of the Texas Clean Air Act. Ryan will seek to recover the County’s costs for responding to the week-long incident.

This is the second suit to arise from the Arkema plant’s explosions. On Sept. 7, seven first responders filed a negligence lawsuit against Arkema, alleging they were not warned of the smoke and fumes and their effects prior to arriving. The responders claim they became ill shortly after they began working on the scene following the Aug. 31 explosion; many left vomiting, gasping for air and unable to breathe during and after rescue efforts.

The Texas Tribune reported that the lawsuit was updated in late September, swelling to include six additional first responders and a number of area homeowners. They claim to have suffered “upper respiratory infections, bronchitis, pneumonia, itchy, burning eyes, tight, burning throats and the like—illnesses and injuries that did not exist prior to the explosions and fires at the Arkema facility and illnesses resulting from and exacerbated by the explosions and fire at the Arkema facility.” Plaintiffs are seeking more than $1 million in damages, according to the suit.

The third lawsuit was filed Oct. 2 by nearby residents who claim their properties were contaminated with toxins. The federal suit details how residents are now suffering from medical problems ranging from scaling and rashes to respiratory problems.

“Based on testing results received to date, Arkema has not detected chemicals in off-site ash, soil, surface or drinking water samples that exceeded Residential Protective Concentration Levels established by TCEQ for soil and groundwater,” company spokesperson Janet Smith said in an email to Houston Public Media.

Harris County’s full statement can be found here.