Overview

On January 31, 2020, the Secretary of Health and Human Services (“HHS”) declared a public health emergency related to the COVID-19 pandemic. Shortly thereafter, hand sanitizer began to disappear from U.S. retailers’ shelves, as anxious consumers (and, unfortunately, opportunistic hoarders and resellers as well) swept up all available stock. In the ensuing months, traditional hand sanitizer producers have found it impossible to keep up with the greatly elevated demand for their products, which are now considered indispensable items in efforts to control the pandemic’s spread.

Seeking to address the supply-demand imbalance currently existing within the hand sanitizer industry, the Food and Drug Administration (“FDA”) issued several industry guidance documents in March of this year (with updates later that month and in April) permitting, within specified parameters, entities not previously engaged in sanitizer manufacturing to produce, on a temporary basis (i.e., for the duration of the public health emergency declaredby the HHS Secretary in January of this year) either alcohol-based sanitizers themselves or the ethanol typically used a s a key pharmaceutical ingredient in such sanitizers.

The industry guidance documents (all of which can be found on the FDA’s website and should be read in their entirety) contemplate that such new, albeit temporary, producers of hand sanitizers (or ethanol for hand sanitizers) might include pharmacists/drug compounders and alcohol production firms (that is, distillers of alcoholic spirits for human consumption), as well as certain other businesses capable of meeting the FDA’s stringent conditions regarding hand sanitizer ingredients and manufacturing processes, as well as its registration and product listing requirements.

Since the FDA first issued its industry guidance documents in March, numerous entities and individuals have begun production of hand sanitizers (or ethanol for hand sanitizers) to address the supply gap resulting from the COVID-19 pandemic. New (albeit temporary) industry participants include manufacturing enterprises, licensed pharmacists, and distillers of alcoholic beverages. Reportedly, over 200 American distilleries (which, obviously, have deep experience in working with ethanol) have registered their facilities with the FDA pursuant to the relevant industry guidance documents.

Ethanol(a/k/a Ethyl Alcohol)

Ethanol is a clear, colorless, and (according to most people) relatively pleasant-smelling liquid made from a variety of feedstocks, including grains and crops high in sugar content, such as sorghum, corn, barley, sugar beets, and sugar cane. While it may be best known as the alcohol found in alcoholic beverages, when ethanol has been denatured (that is, made unfit for human consumption by adding certain other chemicals to it, which also make the odor unappealing), it also has many other commercial applications, including as a fuel additive, industrial solvent, key component of cosmetics and personal care items, and as the active pharmaceutical ingredient in certain disinfecting products, including hand sanitizers.

Keeping Safe While Working with Ethanol

Ethanol is highly combustible, with a low flash point, making leaks (including vapor emissions) potentially quite dangerous, and threats from accidental ignition very serious indeed. To detect, and protect against, risks emanating from leaks or excessive concentrations of ethanol, best practices include placing gas detection monitors, containing visual and audible alarms, in areas where ethanol is used or stored.

PureAireMonitors

PureAire Monitoring Systems’Combustible Gas Monitor (LEL) offers continuous readings of ethanol (and can also be programed to detectisopropyl alcohol, ethane, ethylene, and methyl alcohol). The monitor features an easy to read screen, which displays current ethanol levels for at-a-glance observation by employees, who derive peace of mind from the monitor’s presence and reliable performance. In the event of a leak or buildup of gas to an unsafe level, the monitor will set off an alarm, complete with horns and flashing lights, alerting personnel to evacuate the area. At the same time, the monitor can be programmed to turn on the ventilation system.

PureAire’s Combustible GasMonitor (LEL) is housed in a NEMA 4 explosion proof enclosure suitable for Class1, groups B, C, and D.The enclosure is specifically designed to prevent an explosion. The monitor is well suited for facilities that produce alcohol-based hand sanitizers, as well as alcohol distilleries, ethanol refineries, chemical plants, and any location where monitoring is required for combustible gases.

PureAire’s durable, long-life LEL catalytic sensor will last 5-6 years in a normal environment without needing to be replaced.

Alternative Fuels - A Look At the Current Environment

Overview

Vehicles powered by gasoline and diesel account for emissions of dangerous air pollutants and contribute to the presence of greenhouse gases. Consumers, businesses, and public entities looking for environmentally friendly alternatives to gasoline and diesel-powered cars and trucks have viable choices beyond the well-known battery electric and plug-in hybrid electric variants.  Other options in use today include vehicles powered by natural gas, as well as, on a more limited basis, those powered by hydrogen fuel cells.

Natural Gas Vehicles

Natural gas can be used to power all classes of vehicles, including motorcycles, cars, vans, public transit buses, light and heavy-duty trucks, etc.  Most natural gas vehicles (NGVs) run on either compressed natural gas (CNG), which is typically used for light-duty vehicles (such as motorcycles, cars, taxi cabs, and light trucks), or liquified natural gas (LNG), used in heavy-duty vehicle applications (including public buses, garbage trucks, and the like).

CNG vehicles store natural gas in tanks, where the fuel remains in a gaseous state. Vehicles using LNG can typically hold more fuel than those using CNG, because the fuel is stored as a liquid, making its energy density greater than that of CNG. That makes LNG well-suited for heavy duty commercial trucks requiring the greatest possible driving range. Regardless, because of the lower density of natural gas (whether CNG or LNG), the driving range of NGVs is generally less than that of comparable vehicles powered by gasoline or diesel.

As such, and excluding the commercial and municipal fleet sectors, where fuel sources can be assured, confidence in ability to timely access refueling stations must be a concern for drivers (or potential drivers) of NGVs.

The first vehicles converted to utilize natural gas appeared in the late 1930s, though most of the rapid growth in NGV usage has taken place in recent years. According to the Natural Gas Vehicle Knowledge Base, there are over 27 million NGVs currently on the road worldwide (compared with as few as 1 million as recently as 2000), with over 70% of the present total in the Asia-Pacific region (and only about 225 thousand in North America as of 4/30/2019).

In addition to the reduction in greenhouse gas emissions inherent in choosing natural gas over conventional gasoline and diesel fuels, some businesses and municipalities seeking to meaningfully reduce reliance on fossil fuels are going even further, by focusing on renewable natural gas (RNG), including gas derived from decaying garbage, to power vehicles subject to their authorities.  Indeed, in May 2019, the City of Seattle, Washington announced that the trash truck fleet servicing Seattle will now include some 91 Waste Management vehicles powered by RNG generated by decaying trash from U.S. landfills.

Hydrogen Fuel Cell Vehicles

Importantly for the environment, hydrogen fuel cell electric vehicles (FCEVs) produce no tailpipe emissions.  Fuel cell technology has been around since at least the late 1950s, when Allis-Chalmers tested an FCEV farm tractor, followed some years later by GM’s prototype hydrogen FCEV Electrovan in 1966.  FCEVs use a propulsion system whereby energy, stored as pure hydrogen gas, is converted to electricity by a fuel cell.

Initially, the fuel cells and associated piping were quite bulky (reducing the 6-seat GM Electrovan from a 6-seat van to a 2-seater that could barely accommodate 2 adult passengers), heavy (reducing range and acceleration, such that the Electrovan, which was never produced for sale, had a top speed and range of  only about 70 mph and 120 miles, respectively), and too expensive to mass produce.  As a result, meaningful FCEV production has lagged until well into the 21^st century, when technological innovations have at last begun to make it possible for the FCEV concept to become a functioning reality.

Though FCEVs, and the hydrogen fueling infrastructure (i.e., stations equipped to pump hydrogen gas) necessary to support them, remain in a relatively early stage of development, certain major automobile manufacturers (including Honda, Hyundai, Toyota) are now offering a limited number of FCEVs to the public in certain markets (chiefly within California) where hydrogen refueling infrastructure is already in place, and passenger FCEVs currently in service now have a driving range between refueling of some 300 miles.

However, until retail refueling infrastructure shows a marked increase, most of the anticipated growth in hydrogen FCEV usage is likely to come from the municipal and commercial fleet sectors. By way of example, Toyota and Kenworth have recently announced development of a 10-vehicle zero emissions heavy-duty FCEV truck fleet to be put into service at the Port of Los Angeles.

Refueling and Maintaining Alternative Fuel Vehicles

While far fewer in number, refueling stations and equipment for vehicles powered by natural gas (approximately 1,900 service stations in North America) and hydrogen (no more than 50 service stations in North America, mostly in California, can accommodate hydrogen FCEVs) are similar in appearance to conventional gas stations and pumps, with large tanks from which drivers pump into their vehicles either natural gas, on the one hand, or hydrogen on the other.

According to the U.S. Department of Energy’s Office of Energy Efficiency and Renewable Energy, proper maintenance of NGVs requires that the fuel storage tanks be inspected regularly, following accidents, or when there has been suspected damage.  NGV users must also be aware of end-of-life dates of their tanks, so that the tanks can be properly decommissioned as and when appropriate. Moreover, fuel filters should be inspected and, if necessary, replaced on a yearly basis.

Hydrogen FCEVs are maintained in much the same way as any other electric vehicle, including scheduled maintenance, and, if necessary, replacement of electric components and suspension parts. For a major overhaul, a vehicle will need to be serviced at a so-called “hardened shop”, at which there are specific requirements, including the presence of combustible gas monitors, curtains around the work area, and explosion-proof lighting fixtures.

Gas Detection Monitors Can Improve Safety in Alternative Fuels Servicing Facilities

Natural gas is odorless, colorless, and highly combustible. However, an odorant is normally added to natural gas to alert users if there is a leak.  If a natural gas leak occurs indoors, the gas is likely to rise and remain at ceiling level until ventilated outside.

To detect, and protect against the risks of, natural gas leaks, the U.S. Department of Energy’s Office of Energy Efficiency and Renewable Energy recommends placing combustible gas detection monitors, containing visual and audible alarms, at the highest point (i.e., ceiling level) in natural gas fueling stations and repair facilities.

Hydrogen is also highly combustible, as well as odorless and colorless, making leaks undetectable (and dangerous), absent appropriate monitoring. Because hydrogen gas is light, it may disperse relatively quickly if a leak occurs outdoors, but if a leak occurs inside a building, the gas will, much like natural gas, rise to ceiling height, where it will remain until ventilated outside.

The International Fire Code and the National Fire Protection Association have set out requirements mandating the use of hydrogen sensors in hydrogen fueling stations and repair facilities.
Ideally, if there is a leak (whether of natural gas or hydrogen gas) in a facility, the combustible gas detection monitors should automatically activate that building’s ventilation system.

PureAireMonitors

PureAire Monitoring Systems’Combustible Gas Monitor (LEL) offers continuous readings of hydrogen, compressed, and liquified natural gas. In the event of a leak or buildup of gas to an unsafe level, the monitor will set off the alarm, replete with horns, flashing lights, and turn on the ventilation system.

PureAire’s Combustible GasMonitor (LEL) is housed in a NEMA 4 explosion proof enclosure suitable for Class1, groups B, C, D.