EPA Emerging Viral Pathogens – and Hard Surface Disinfectants
At present, the virus responsible for COVID-19 is not on any EPA registered product lists, and therefore there is not a disinfectant which can make a specific claim to be effective against this new virus. However respiratory illnesses attributable to COVID-19 are caused by a coronavirus, and WAXIE can provide several broad-spectrum hard surface disinfectants that have been shown to be effective against other similar viruses, such as Human Coronavirus, SARS associated Coronavirus, Porcine Respiratory & Reproductive Syndrome Virus (PRRSV), Rotavirus, and Rhinovirus Type 37.
When used in accordance with the directions on the label for each associated product, these hard surface disinfectants have been shown to be effective against the virus (or viruses) referenced on the master label for that product. There are a number of disinfectant products which have already successfully gone through, or are in the process of going through, the protocol for the EPA Emerging Viral Pathogens Guidance for Antimicrobial Pesticides.1
List N: Disinfectants for Use Against SARS-CoV-2
On Thursday March 5, 2020, the U.S. Environmental Protection Agency (EPA)2 released a list of EPA-registered disinfectant products that have been qualified for use against SARS-CoV-2, the novel coronavirus responsible for COVID-19.
This list of disinfectant products, also referred to as List N: Disinfectants for Use Against SARS-CoV-2,3 includes products which have submitted data to EPA to show that they are effective against viruses which are harder to kill than SARS-CoV-2. The products on this initial list have been selected because they are amongst the first to be recognized by the EPA’s Emerging Viral Pathogens Guidance.4
Why Emerging Viral Pathogen Guidance
The EPA developed and finalized this Emerging Viral Pathogen Guidance5 in 2016 as a result of growing public health concerns in the United States and globally about response to emerging pathogens, and the fact that pre-existing EPA-registered disinfectant product labels are not able to make any specific claims against a new and previously unidentified viral pathogen.
Because it is not possible to predict the occurrence of any particular emerging viral pathogen, and because any new pathogen is most likely unavailable for testing right away, few, if any EPA-registered disinfectant product labels have typically been able to specify use against a new category of infectious agents. And because testing the efficacy of an EPA-registered disinfectant against a new emerging pathogen can be difficult to accomplish in a timely manner, the Emerging Viral Pathogen Guidance was intended to allow for a more rapid response in the event of an outbreak.
The Emerging Viral Pathogen Guidance outlines a voluntary pre-approval process for making claims against emerging viral pathogens, and in the event of an outbreak, companies with pre-approved products can make off-label claims in technical literature, non-label-related websites, and social media.
Criteria for Disinfectants to Make Claims Against Emerging Viral Pathogens
In order to be eligible to be included on this list of disinfectants which can make claims against an emerging viral pathogen, the product should meet both of the following criteria:
Viral Subgroup Classification
This approach which considers the viral subgroup classification was taken because the EPA and the Centers for Disease Control and Prevention (CDC) recognize that certain microorganisms can be ranked with respect to their tolerance to chemical disinfectants. The Spaulding Classification Model7 is used by CDC and it tiers microorganisms in accordance with the level of resistance to being killed (or inactivated) by typical disinfectant products. With this approach viruses are divided into three viral subgroups based on their relative resistance to inactivation. According to this hierarchy, if an antimicrobial product can kill a small, non-enveloped virus, it should be able to kill any large non-enveloped virus or any enveloped virus. Similarly, a product that can kill a large non-enveloped virus should be able to kill any enveloped virus. As described in the EPA Emerging Pathogen Guidance to Registrants,5 here is an overview of the three viral subgroups:
Small Non-Enveloped Viruses: these viruses can be highly resistant to inactivation by disinfectants. Despite the lack of a lipid envelope, these organisms have a very resistant protein capsid.
Large Non-Enveloped Viruses: these viruses are less resistant to inactivation than small non-enveloped viruses. Although they have a resistant protein capsid, their larger size makes them more vulnerable to inactivation than a small non-enveloped virus.
Enveloped Virus: these viruses are the least resistant to inactivation by disinfectants. The structure of these viruses includes a lipid envelope which is easily compromised by most disinfectants. Once the lipid envelope is damaged, the integrity of the virus is compromised, thereby neutralizing its infectivity.
As summarized in an article in Infection Control Today,8 the general idea of the EPA’s Emerging Viral Protection Guidance is that in order for a disinfectant to be considered effective against an emerging viral pathogen, it must demonstrate efficacy – in other words, have an EPA-approved claim – against viruses that are harder to kill than the specific emerging pathogen in question.
The SARS-CoV-2 virus which is responsible for COVID-19 is an enveloped virus and therefore it is the easiest virus to inactivate. An EPA-registered broad-spectrum hospital-grade disinfectant with a claim against at least one large non-enveloped virus or one small non-enveloped virus can be expected to be effective at inactivating an enveloped virus.
Selecting the Right Disinfectant Product
As referenced on the EPA website,3 the List N: Disinfectants for Use Against SARS-CoV-2 is not an exhaustive list of disinfectant products which can be used to inactivate the new strain of coronavirus, “there may be additional disinfectants that meet the criteria for use against SARS-CoV-2”, and the EPA is expediting review of submissions to identify additional disinfectant products which can potentially be used due to the outbreak of the novel coronavirus.21
WAXIE has several disinfectant products which meet the criteria to qualify for the emerging viral pathogen claim for an enveloped virus, and several have been submitted following EPA’s guidance for expedited emerging viral pathogens claim submissions.9 In addition, there are several products which have already successfully gone through the process, and are currently recognized on List N: Disinfectants for Use Against SARS-CoV-2.
Coronavirus Update – New name for the disease and virus and the potential impacts on product supply availability
New Name – COVID-19 Virus
Since a new strain of coronavirus was first identified and began to be reported in the news at the very end of 2019, there has been a tremendous amount of public interest to learn more about the transmission of this virus – and as new cases continue to be diagnosed across the globe, there is an increasing desire to learn what steps people can take to protect themselves from becoming infected and getting sick.
As the global community learns more about this new strain of coronavirus, we also are learning more about how viruses and diseases are named. Although this new strain (formerly referred to as “2019 novel coronavirus” or “2019-nCoV”) was first reported on December 31, 2019, the disease the virus is causing in humans wasn’t given an official name until February 11, 2020 when the World Health Organization named it Coronavirus Disease 2019 (COVID-19)1, with the explanation that the “CO” comes from “COrona”, the “VI” comes from “VIrus”, the “D” comes from “Disease”, and the “19” comes from the year it was first identified “2019”.
Further, WHO explains that naming a disease is separate from naming a virus. Diseases are named to enable discussion on prevention, spread, transmissibility, severity, and treatment – and since human disease preparedness and response is WHO’s role, the name of the disease is handled by WHO in the International Classification of Diseases (ICD)2.
On the other hand, viruses are named based on their genetic structure in order to facilitate the development of diagnostic tests, vaccines, and medicines – and since virologists and the wider scientific community do this work, viruses are named by the International Committee on Taxonomy of Viruses (ICTV)3.
On the same day the disease was named COVID-19 by WHO, the virus was named SARS-CoV-2 by the Coronavirus Study Group (CSG) of the ICTV4 based upon the similarities this new strain has with the virus which caused an outbreak of Severe Acute Respiratory Syndrome (SARS)5 in 2002-2003.
Understandably, the announcements of two separate new names to describe both the disease and the virus has been the cause of some confusion6, and WHO has expressed grave concerns about referring to the new virus as SARS-CoV-2. Instead, WHO has announced that they will refer to the new virus as “the virus responsible for COVID-19” or “the COVID-19 virus” out of concern that using the SARS-CoV-2 virus name will create additional fears in some populations (especially in Asia) which were most negatively affected by the SARS outbreak in 2002-2003.
Product Supply Disruptions
The COVID-19 virus has impacted China during their Lunar New Year, a time when factories close and therefore new products are not being manufactured. The global supply chain is able to account for this time of planned factory shut downs each year by ordering extra products ahead of time, and then placing future orders to commence as soon as the factories begin production again after the conclusion of the Lunar New Year.
However, since obviously were no plans in place for the disruption caused by the COVID-19 virus, within a very short time of the new virus being reported in the news, the global supply of face masks became constricted7. China is responsible for about 50% of the world’s face mask production, and the country has scrambled to snap up any excess supply from overseas while adopting quasi-wartime rationing of masks in an effort to ensure supply for their country. As a result, inventories of face masks (including and especially those which are N95 rated) from all over the world have been wiped out, and it is predicted that global demand will continue to exceed whatever can be produced in China and the rest of the world in the near term future.
The Lunar New Year typically begins to impact production in China in early January, with operations back to normal towards the end of February – however, this year the COVID-19 virus has delayed the return of workers back to the factories. As a result, it is possible that supply for other items which are sourced from China to be disrupted8. Any company – including Apple, Walmart, and WAXIE – that imports products from China may experience production and distribution slowdowns. Please know that WAXIE is working with its suppliers to mitigate any disruptions in the supply of products sourced from China, and we will continue to keep our customers apprised of any possibilities for outages.
According to the Centers for Disease Control and Prevention (CDC),1 the virus responsible for Coronavirus Disease 2019 (COVID-19) is a new virus which has been identified as the cause of an outbreak of respiratory illness in Wuhan City, Huebei Province in China. The earliest reported cases had a link to a large seafood and animal market in Wuhan, suggesting an initial animal-to-person spread, however a growing number of subsequent patients have not had exposure to animal markets, indicating that a person-to-person spread may be occurring. The CDC states2 that COVID-19 is a new disease, and that there is still much to be learned about how it spreads, the severity of the illness it causes, and the extent to which it may spread in the United States.2
Since this new strain of coronavirus3 was originally detected on December 31, 2019,4 it has subsequently spread to 29 of China’s 31 provinces,5 and is now beginning to spread through other countries. The first case in the United States6 was confirmed on January 21, 2020 in Snohomish County in Washington state,7 and as of March 16, 2020 there are now over 4,000 confirmed cases in the United States.8 In total, according to the Coronavirus COVID-19 Global Cases map provided by the Johns Hopkins University website, there are almost 180,000 confirmed cases of this new virus globally, with over 7,000 total deaths and almost 80,000 total recovered.8
The situation continues to be closely monitored by public health officials, with active communication taking place amongst the global public health community and the governments of effected countries and communities. The CDC, World Health Organization (WHO), and the global public health community are providing instruction9 for the global population to practice good hand hygiene, cover coughs and sneezes, avoid close contact with anyone with cold or flu-like symptoms, and to clean and disinfect high touch surfaces.
Map of Countries With Confirmed Cases of COVID-19.
Image Source: CDC
According to the World Health Organization (WHO),10 Coronaviruses (CoV) are a large family of enveloped viruses which are known to cause illnesses ranging from the common cold, to the more severe illnesses such as Middle East Respiratory Syndrome (MERS-CoV) and Severe Acute Respiratory Syndrome (SARS-CoV). The coronavirus responsible for COVID-19 has been named SARS-CoV-2.11
Coronaviruses are zoonotic,12 meaning they are initially transmitted between animals and people, and these type of viruses are named for the crown-like spikes (or “coronas”) on their surface13 when viewed under an electron microscope. Human coronaviruses were first identified in the mid-1960s, and with the recent identification of the virus responsible for COVID-19, there are now seven known strains of human coronaviruses which can infect people.13
Most coronaviruses are not life threatening, and people around the world commonly get infected every year with one of the four known human strains of coronaviruses which cause the common cold.13 The COVID-19 strain is being monitored closely as a potentially more serious strain of human coronavirus similar to the strain identified as Middle East Respiratory Syndrome (MERS-CoV)14, which was responsible for an outbreak which started in Saudi Arabia in 2012, and the strain identified as Severe Acute Respiratory Syndrome (SARS-CoV)15, which was responsible for an outbreak which started in China in 2003.
For confirmed cases of COVID-19 infections, symptoms16 have ranged from infected people with little or no symptoms to infected people becoming severely ill and dying. Symptoms can include one or more of the following:
At this time, CDC believes that symptoms may appear in as few as 2 days or as long as 14 days after exposure, but since this strain is still so new and in need of further research, these assumptions are based on observations of how symptoms developed with the MERS-CoV strain.16
In the most serious cases, COVID-19 infection can lead to pneumonia, severe acute respiratory syndrome, kidney failure, and even death.12
While there is currently no vaccine available for COVID-19, CDC is recommending that the public practice everyday preventive actions17 which can help to limit the spread of respiratory viruses, including the following best practices:
Infographic – Reduce Your Risk of Coronavirus
Source: World Health Organization