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Daily News Blog

28
Aug

EPA Threatens Public Health, Waiving Safety Review of Disinfectants To Be Used by American Airlines and Health Care Facilities; Need Questioned while More Uses Expected

(Beyond Pesticides, August 28, 2020) The Environmental Protection Agency (EPA) has granted “emergency” permission to the State of Texas to allow the use of SurfaceWise®2, an unregistered pesticide, as an anti-viral surface coating. The manufacturer, Allied Bioscience, says the compound can kill coronaviruses (including SARS-CoV-2) starting at two hours post application and for up to seven days, but it is not included on EPA’s List N, of disinfectants effective against SARS-CoV-2. EPA has permitted this use via the authority of Section 18 of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), which allows for “emergency” use of non-registered pesticides, typically to deal with extreme threats to agricultural activities. It is rarely used for public health emergencies. Beyond Pesticides recognizes the need for protection from transmission of the novel coronavirus, and maintains that it ought to and can be done without exposing people to toxic synthetic pesticides that have not undergone evaluation for safety. See Beyond Pesticides’ guidance on effective and safe precautions against the novel coronavirus.

The Texas Department of Agriculture secured the EPA exemption, making the state the first to do so; Allied BioScience is pursuing this emergency waiver across all 50 states. The exemption grants American Airlines and two health care facilities in the state the ability to use the unregistered pesticide, which is applied by electrostatic spraying. Usually, a Section 18 exemption would be made absent other viable alternatives to address the problem and when there are at least minimal health and environmental safety data available for the compound; neither is the case for SurfaceWise®2.

This one-year use allowance of the product would appear to be a specific exemption more than a response to a public health “emergency.” From the EPA website: “Section 18 of the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA) authorizes EPA to exempt state and federal agencies from certain provisions of FIFRA and allow unregistered uses of pesticides to address emergency conditions. Under such an exemption, EPA allows limited use of a pesticide in defined geographic areas for a finite time, once EPA confirms that the situation meets that statutory definition of ‘emergency condition.’ Section 18 emergency exemptions must be requested by a state or federal agency. Section 18 emergency exemptions are routinely granted for use in agricultural settings involving invasive pest outbreaks, though rarely for public health emergencies.”

EPA’s news release on the exemption says: “SurfaceWise2 is meant to inactivate viruses that land on a surface between regular cleanings. This product is not a replacement for routine cleaning and disinfection with products from EPA’s List N.” In the COVID-19 pandemic, EPA has created its “List N” — disinfectants that meet agency criteria for efficacy against SARS-CoV-2 (the virus that causes COVID-19) and other coronavirus illnesses, but which are not necessarily evaluated for safety. There are hundreds of compounds listed on List N, which begs the question: what is the “emergency need” for SurfaceWise®2?

Allied BioScience touts the compound as “non-toxic, non-irritating, odorless and contain[ing] no chemicals that produce harmful vapors or gases.” Yet, on EPA’s List N are a legion of products with active ingredients known as quaternary ammonium compounds or “quats,” about which there are toxicity concerns. In fact, roughly half of the List N products contain a quat as the single active ingredient. An active ingredient in SurfaceWise®2 is a quaternary ammonium.

Quats are organic, ionic chemical agents with properties of both surfactants and disinfectants; they have been used in disinfectant products for many years. However, especially over the course of the past decade or so, quats have been linked to a range of human health harms, including increased risks of asthma and allergic response; mutagenicity (e.g., some quats have been shown to damage DNA in human lymphocytes at much lower levels than are present in cleaning chemicals); contact dermatitis and other skin irritation; lowered fertility; and potential and significant disruption of key cellular processes (see more below). The National Institutes of Health designates quaternary ammonium as “asthma-causing and irritable to eyes and skin, flammable and corrosive, harmful to aquatic ecosystems, and persistent in the environment.”

There are also concerns about some quats’ ability to catalyze antibiotic resistance, and impacts on the human respiratory system — of particular concern in the era of COVID-19, which in many people damages lung tissue and compromises oxygen delivery to the body’s cells. The use of quats, which have been on the market since the early 20th century (before EPA began regulating potentially harmful chemicals) should be less facile — particularly during a massive public health pandemic.

University of California, Davis toxicologist Gino Cortopassi, PhD has studied causes of mitochondrial dysfunction for the past decade. Mitochondria are the “power plants” of cells, transforming food into the chemical energy needed for cellular biochemical processes — cellular respiration, or use of oxygen delivered by circulation, being a primary one. Cells use ATP (adenosine triphosphate) to store the energy that mitochondria produce. Dr. Cortopassi’s research has found that quats compromise both mitochondrial consumption of oxygen and the creation and storage of ATP. This finding should be a red alert for the use of quat compounds during the COVID-19 pandemic.

As Beyond Pesticides wrote in August 2020, “Individuals and government officials, alike, should observe all chemical ingredients on the disinfectant and sanitizer product labels and look at the use instructions to ensure that the method of use is safe. . . . Additionally, the U.S. Environmental Protection Agency (EPA) registers disinfectants as pesticides designed for use on hard surfaces, but not bare skin like sanitizers. It is essential that when EPA weighs risks and benefits of pesticide use, it does not allow harm to those disproportionally impacted by these chemicals like farm/landscape workers and people of color, who may suffer elevated exposure to the virus as essential workers. An evaluation of the contribution of pesticide use and exposure to health outcomes of COVID-19 is urgently needed.” For the facts on meeting health protection needs for disinfection, see Beyond Pesticides’ webpage on Disinfectants and Sanitizers.

Another, earlier iteration of this product, SurfaceWise, is registered as an anti-microbial surface coating, but SurfaceWise®2 is not currently on List N and has not been evaluated by EPA. The manufacturer has not submitted the necessary data to qualify for registration under FIFRA, but EPA notes: “Over the coming months, Allied BioScience will pursue a non-emergency approval under FIFRA Section 3 by submitting additional data to meet EPA’s registration requirements as an antiviral surface coating. If the full registration process is completed, the product would become available for purchase by members of the public.” This would potentially open the door to people using SurfaceWise®2 in their homes, subjecting themselves and their families to chronic and repeated exposures to a product that could make them more vulnerable were they to contract the novel coronavirus.

EPA’s August 24 news release goes on, essentially, to invite more entities to apply for “emergency use” exemptions under Section 18. The news release mentions efficacy, but nowhere is there a word about safety: “EPA anticipates posting information for companies or individuals who are interested in pursuing a FIFRA Section 3 registration for antiviral surface coatings in the coming weeks. In the interim, states or federal agencies interested in pursuing a Section 18 Emergency Exemption Request for products that claim residual efficacy against viruses for up to seven days should be prepared to include efficacy data demonstrating that the product is durable and effective against viruses in their applications. Durability and efficacy should both be evaluated. For example, antiviral efficacy should be assessed using coated surfaces that have been exposed to physical touches/abrasion and treatment with disinfectants. EPA will review the results of these studies to ensure that surface coatings remain effective under the anticipated proposed conditions of use.”

As the public and many, many businesses struggle to find ways to resume economic and other kinds of “normal” activities, there have been pushes both to resume potentially risky activities and to make some of those activities safer — or at least to make them seem safer. American Airlines’ wish to deploy SurfaceWise®2 on its cabin surfaces can be seen as both. Airlines are facing economic hits from generally reduced air travel during the pandemic, and backlash due to images of airlines packing planes full. Many potential travelers, concerned about transmission of the novel coronavirus during flights, have opted not to fly. Yes, SurfaceWise®2 kills the virus. But this “emergency” exemption appears to some extent to be a solution in search of a problem.

In the initial stages of the pandemic, there was much concern about transmission via “fomites” — materials or objects that can transmit infection. Since then, nearly all of the emerging science has indicated that surfaces are very rarely responsible for transmission of the virus. The novel coronavirus is far more commonly transmitted via close personal contact when an infected person coughs, breathes, or speaks, according to the Centers for Disease Control and Prevention (CDC), than via contaminated surfaces.

Catching the virus while touching a surface would be “quite rare” but not “impossible,” according to The Atlantic magazine. Donald Schaffner, PhD, a food-microbiology professor who studies disease contamination at Rutgers University, told the magazine, “You had clear airborne transmission with many, many opportunities for mass fomite transmission in the same place. But we just didn’t see it. In the entire peer-reviewed covid-19 literature, I’ve found maybe one truly plausible report, in Singapore, of fomite transmission. And even there, it is not a slam-dunk case.”

It is worth noting that one of the touted features of SurfaceWise®2 — its seven-day efficacy — also means that human exposures to it may not be brief or incidental, but could, in the case of a cross-country flight, for example, result in exposure of five or six hours’ duration. Airline workers would also experience chronic exposures to the chemical, which Allied BioScience says “won’t wipe off with repeated cleaning — even with harsh or abrasive chemicals.” As The Washington Post reports, “Health and chemical experts say the cleanser [SurfaceWise®2] might actually harm passengers and flight attendants and do little to protect against the virus, which is mainly transmitted through the air in closed spaces.”

A senior scientist at the Natural Resources Defense Council, Jennifer Sass, PhD, comments, “‘It would be great if this was a miracle solution, but it’s not. There’s plenty of risk here and too much we don’t know about how this chemical could actually harm people.’” The WaPo article continues: “[Dr.] Sass said the company’s ‘Material Safety Data Sheet,’ which lists the common hazards of a product, acknowledged concern about prolonged skin and eye contact, both possible in environments such as the cabins of aircraft. The data sheet also does not list tests for chronic or long-term effects, she added. ‘Although acute toxicity seems to be very low, many people will be exposed to it on a daily basis,’ including airline workers.”

Claudia S. Miller, MD, MS, an immunologist, allergist, and professor emeritus at the University of Texas, asserts in the WaPo article: “‘People most vulnerable to the novel coronavirus — those with asthma, chemical intolerances or certain allergies — may have greater irritation from exposure to the disinfectant. . . . I’m very concerned when we’re using chemicals that may affect the more sensitive subset of the population. I don’t like the idea of exposing people to disinfectants on top of this risk of having a virus infect their lungs.’”

Dr. Miller also points out that, “When the coating is sprayed, it emits vapors that could be hazardous, creating risks especially for the workers who apply it. In a contained environment such as an airplane, those vapors could linger without ventilation.” Further, the product’s proposed label instructs those applying the chemical to use personal protective equipment, and to wear long pants, shoes, and socks, and American Airlines will provide to applicators gloves that are resistant to chemicals, as well as approved N95 or KN95 respirators. If the product is safe, why all these precautions? It is notable that neither the original SurfaceWise® nor this newer SurfaceWise®2 shows up in the database of EPA’s Safer Choice / Design for the Environment program, which purports to help “consumers, businesses, and purchasers find products that perform and contain ingredients that are safer for human health and the environment.”

American Airlines is pleased with the emergency exemption, which allows it to advertise that the company is “taking bold measures and using the latest products and technology to help ensure our customers’ well-being when they travel with us. . . . We look forward to also seeing SurfaceWise2 used in offices, schools, gymnasiums and other high-traffic areas to support the nation in safely reopening.” It intends to use SurfaceWise®2 on interior aircraft surfaces, and plans to use the product throughout its fleet, including those in its American Eagle regional partners.

Beyond Pesticides believes that this EPA emergency use exemption, and any that might follow in response to applications from other localities for use of SurfaceWise®2, should be subject to the public comment process required by FIFRA. Federal regulations (§166.24: Public notice of receipt of application and opportunity for public comment) require that, “The Administrator shall issue a notice of receipt in the Federal Register for a specific, quarantine, or public health exemption and request public comment when any one of the following criteria is met:” — which list of criteria includes “a complete application for registration of that use and/or a petition for tolerance for residues in or on the commodity has not been submitted to the Agency.”

That said, because SurfaceWise®2 contains the active ingredient 1-octadecanaminium,N,N-dimethyl-N[3-(trihydroxysilyl)propyl],chloride, which has been used in other registered compounds, EPA might not consider it a new active ingredient — in which case, the agency might argue the public notice and comment requirements does not apply. However, even new uses of active ingredients already registered by EPA must, by law, be subject to review because of new exposure patterns and an assessment of cumulative risk.

Way back in 2002, Beyond Pesticides wrote about this “emergency” loophole in the regulation of toxic pesticides, saying: “Section 18 emergency exemptions provide a loophole by which pesticides are used without the scrutiny provided in the registration process. Through declarations of emergencies and crises, states allow use of pesticides which for several reasons (including lack of a sustainable market due to rapid development of resistance, data gaps, or EPA’s concern about certain risks) cannot be registered for additional uses. EPA has said that pesticides with data gaps will not be allowed to expand their use patterns, but this restriction does not apply to emergency exemptions and special local needs registration.”

Everyone feels beleaguered by this pandemic and its outfalls, and wishes life could return to something nearer “normal.” Yet people’s understandable yearnings for “normal” ought not be exploited by industry or government, particularly to introduce “fixes” that may actually mitigate against human health and well-being. With this emergency exemption, EPA and industry are conducting a dangerous kind of legerdemain: distracting from scientifically supported transmission scenarios with a “solution” for one that barely exists — the vanishingly small possibility that COVID-19 could be spread by contact with contaminated surfaces. Tragically, EPA is doing exactly this and allowing unnecessary exposures to a toxic pesticide in the process.

Beyond Pesticides maintains that during public health emergencies involving infectious diseases, such as the current coronavirus pandemic, it is critical to scrutinize practices and products very carefully so that risks presented by the crisis are not exacerbated by unnecessary threats from toxic products promoted as protective. Again, consult Beyond Pesticides fact sheet on safe protections.

Sources:

https://www.washingtonpost.com/travel/2020/08/25/american-will-be-first-airline-use-coating-that-kills-coronavirus-up-seven-days/?utm_campaign=wp_main&utm_medium=social&utm_source=facebook, https://www.epa.gov/newsreleases/trump-epa-approves-first-ever-long-lasting-antiviral-product-use-against-covid-19, and

https://www.washingtonpost.com/climate-environment/2020/08/26/epa-coronavirus-cleaner/

All unattributed positions and opinions in this piece are those of Beyond Pesticides.

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