Case Study on Standards: Disinfection
As part of its 125th anniversary celebration, ASTM International invited case study submissions from committee members around the world, highlighting standards that have made a significant impact in society – and that have bettered the world around us. Numerous exceptional submissions were received, making the work of ASTM’s panel of judges even more difficult in narrowing down the list to eight winners.
Standardization News is publishing all eight winning entries in 2023. We continue the series with a standard for disinfection of environmental surfaces from the committee on pesticides, antimicrobials, and alternative control agents (E35).
Identify the need for the development of this standard: What problem is this standard trying to solve? Who initiated the development of the standard?
The standard practice to assess virucidal activity of chemicals intended for disinfection of inanimate, nonporous environmental surfaces (E1053) was published in 1985 to meet a need to standardize virucidal disinfection testing to allow a consistent measure of the efficacy of disinfectants, sterilants, etc. to inactivate dried viruses on hard, non-porous surfaces for the purposes of U.S. Environmental Protection Agency (EPA) and U.S. Food and Drug Administration (FDA) registration.
The method may have also helped industry move away from using live animal models (e.g., chimpanzees for Hepatitis B virus claims, mice and chicks for other viruses). The EPA’s 1981 and 1986 product performance guidelines for viral testing did not identify a standardized method. Though EPA accepted the method earlier, it was formally incorporated into the EPA registration requirements in 810.2200 in 2012 and remains today. It has also been incorporated into Health Canada registration requirements.
Which interest groups participated in the development and/or revision of the standard?
Though the history does not seem to have been recorded in 1985, all members of the subcommittee on antimicrobial agents (E35.15) most likely participated. Today, we are working on an extensive revision of the method. Element, a contract laboratory, is leading the effort with significant input from the EPA’s Microbiology Laboratory; EPA’s registration staff from the Office of Pesticide Programs Antimicrobial Division Efficacy Branch; and about 35 members of the subcommittee.
How is this standard commonly used by industry?
This standard is used throughout the world by regulatory authorities to support the registration of virucidal disinfection claims. The method has been adopted by the EPA, Health Canada, and Australia, for example. Many other jurisdictions also accept E1053 to support viral disinfection claims. There are thousands of registered disinfectants in the U.S. and most will contain viral label claims based on this method. A specific example is Lysol Disinfectant, EPA Registration No. 777-99, where all 36 viral claims on the label are supported by the standard.
Since publication, how have these standards impacted health and safety?
The published standard immediately became the favored method by labs, registrants, and regulatory agencies as a standard method to measure product effectiveness against viruses. This method likely supports all U.S. virucidal disinfection claims on product labels today. It has most recently been used by EPA, Health Canada, and other countries to support the international response to the SARS-CoV-2 pandemic. The method has been used by registrants to test and add claims to product labels so users can protect themselves from the virus. These products play a critical role in public health to interrupt transmission of viruses in residential, healthcare, and institutional settings. Today, the Monkeypox virus is being adapted to E1053 to assure efficacy/attain EPA label claims to respond to this emerging viral public health outbreak. This method is the foundation in North America and globally to address emerging viruses as they appear and assess products for their ability to reduce transmission.
How do consumers and the public benefit from these standards?
This method supports viral claims on products the public uses. It provides confidence that products have met the regulatory standard of effectiveness to make such claims. These products are recommended by CDC, WHO, etc. to respond to viral public health outbreaks. Viral disinfectants tested by E1053 are instrumental in reducing nosocomial infections in healthcare institutions, cold and flu in schools, viral foodborne illness in restaurants, and food manufacturing. The use of this method to test SARS-CoV-2 and variants has been vital to the world’s response to the COVID-19 pandemic and will be for future emerging pathogens. EPA maintains lists of products passing the E1053 requirement so users can easily find products to meet their needs.
Can you provide data to support the safety, economic, or other impacts of the standard? If yes, please summarize the data and provide citations.
The EPA database allows access to all EPA registered products and their master labels: (https://ordspub.epa.gov/ords/pesticides). Other EPA databases (NPIRS and Knowtify) can be accessed to view the titles of the studies. The labels list the viral claims supported by this standard for each individual product. The EPA has registered over 900 basic disinfectant registrations, which are subregistered to provide the U.S. with over 14,000 registered disinfectants. Most of these will have at least one viral claim and some will have many more like the example used previously. The vast majority of these claims are supported by testing conducted in accordance with E1053. These products are used in a myriad of ways to reduce viral disease transmission.
Are you aware of any regulatory adoption (domestic or international) or broad international use of the standard? If yes, please provide details.
This standard is used throughout the world by regulatory authorities to support the registration of virucidal disinfection claims. The method has been adopted by the EPA, Health Canada, and Australia: for example. Many other jurisdictions also accept the standard to support viral disinfection claims.
Do these standards address any of the 17 United Nations Sustainable Development Goals?
This method would have a direct impact on SDG 3: Good health and Well-Being and SDG 6: Clean Water and Sanitation. This is because of its role in measuring the efficacy of disinfectants that are then used to disinfect surfaces to reduce transmission of viral disease between humans and animals.
This method could also be said to apply to SDG 15: Life on Land, as it has been instrumental in helping to reduce the use of live animals for this testing by providing guidance on how to use transformed host cell lines to measure the virucidal endpoint. ■
Rhonda Jones RM (AAM), CEO, Scientific & Regulatory Consultants, Inc.
Member of subcommittee on antimicrobial agents (E35.15)