Posted on October 26, 2021 by Lisa M. CampbellBy Heather F. Collins, M.S. and Barbara A. Christianson
On October 15, 2021, the U.S. Environmental Protection Agency (EPA) announced that it has revised its guidance for evaluating the efficacy of antimicrobial pesticides against Candida auris (C. auris). EPA states that pesticide manufacturers seeking to register their products with a C. auris claim should use this updated guidance to test the effectiveness of the products against a drug-resistant strain of C. auris.
EPA states that C. auris is an emerging, multidrug-resistant yeast (a type of fungus). It can cause serious infections and spreads easily among hospitalized patients and nursing home residents. C. auris can spread in healthcare settings through contact with contaminated environmental surfaces or equipment, or from person to person. According to the Centers for Disease Control and Prevention (CDC), more than one in three patients with an invasive (e.g., affecting the blood, heart, or brain) C. auris infection die.
In 2017, in consultation with the CDC, EPA issued interim guidance for testing the effectiveness of hospital disinfectants against C. auris. Subsequently, based on input from the CDC on its tracking of clinical cases of multi-drug resistant C. auris isolates in the United States, the laboratory data were generated to ensure antimicrobial efficacy against a more relevant strain of the pathogen.
Working closely with experts from the CDC, EPA conducted a comparative evaluation of isolates and found that the drug-resistant isolates were more tolerant to some disinfectant treatments. Since a drug-resistant isolate (AR Bank #0385) is highly relevant to current outbreaks in the United States, it is considered a suitable test microbe for regulatory purposes.
The guidance provides recommendations for laboratory methodology on how to:
- produce and store cultures of drug-resistant C. auris, and
- evaluate the effectiveness of antimicrobial products intended to treat surfaces contaminated with drug-resistant C. auris.
Under the updated guidance, all new products seeking registration with claims against C. auris should test for efficacy using the more relevant strain (AR Bank #0385). Efficacy testing using AR Bank #0381 is acceptable in some cases where the study initiation date is between October 15, 2020, and October 15, 2021. For study initiation dates between October 15, 2020, and October 15, 2021, EPA will accept studies conducted with isolate AR Bank #0381 for products whose active ingredients are either sodium hypochlorite or hydrogen peroxide plus acetic acid. For products with other active ingredients, it will be necessary to retest using isolate AR Bank #0385.
Existing antimicrobial products with C. auris claims based on the previous strain (AR Bank #0381) will be allowed to retain their claim of effectiveness against C. auris. To claim effectiveness against drug-resistant C. auris, EPA requires retesting with the more relevant strain (AR Bank #0385) identified in the updated guidance and according to the revised test method.
Posted on November 11, 2020 by Lisa M. CampbellBy Heather F. Collins, M.S. and Barbara A. Christianson
On November 4, 2020, the U.S. Environmental Protection Agency (EPA) published a notice in the Federal Register announcing the release of an updated list of pests of significant health importance for public review and comment. 85 Fed. Reg. 70146.
EPA, in coordination with the Centers for Disease Control and Prevention (CDC) and the U.S. Department of Agriculture (USDA), identifies pests of significant public health importance, and in coordination with the Public Health Service, develops and implements programs to improve and facilitate the safe and necessary use of chemical, biological, and other methods to combat and control such pests of public health importance. According to EPA, the list serves as a tool for private and public organizations, including local or state governments, departments of public health, pesticide registrants, and non-governmental organizations, when making decisions and plans about future public health actions.
Since this list’s original publication in 2002, new vector-borne diseases have been identified and pests that had been previously thought of as benign or nuisance pests have been found to impact adversely public health. EPA, CDC, and USDA collaborated to update the list to incorporate significant changes regarding vector-borne diseases and related research, and eliminate gaps or ambiguities in the current pests list.
EPA states in the notice that the draft Pesticide Registration (PR) Notice 2020-X more precisely describes both the pests and expected public health impacts and adds several new pests (the brown dog tick) and public health impacts (Zika fever and coronaviruses like SARS-CoV-2) and that other pests have been renamed or grouped with similar species or removed altogether (hobo spider).
Draft PR Notice 2020-X describes the groups of pests and their potential impact on public health as follows:
- Arthropods: The listed arthropods may cause asthma or trigger allergies, contaminate food, irritate skin, cause direct injury, or carry diseases such as epidemic typhus, trench fever, epidemic relapsing fever, malaria, encephalitis (St. Louis, Eastern, Western, West Nile, and LaCrosse), yellow fever, dengue fever, and many others.
- Vertebrates: The listed organisms have the potential for direct human injury and can act as disease reservoirs for rabies and other diseases. The rats and mice include those that spread rodent-borne diseases and contaminate food for human consumption.
- Microorganisms and acellular particles: This category includes listed bacteria, fungi, protozoans, viruses, virusoids, and prions. The microorganisms and acellular particles listed in this category cause diseases such as COVID-19, cholera, meningitis, Legionnaire’s Disease, and many others.
The complete list of pests is identified in draft PR Notice 2020-X in Appendix A.
EPA states that the list does not affect the regulatory status of any registration or application for registration of any pesticide product.
Comments on the draft PR Notice are due on or before January 4, 2021, in Docket EPA-HQ-OPP-2020-0260.
Posted on April 30, 2020 by editorBy Heather F. Collins, M.S. and Barbara A. Christianson
On April 29, 2020, the U.S. Environmental Protection Agency (EPA) and the Centers for Disease Control and Prevention (CDC) released updated guidance to give assistance to facility operators and families on how to clean and disinfect spaces properly. Developed in cooperation with the White House, the updated guidance provides step-by-step instructions for public spaces, workplaces, businesses, schools, and homes, and falls in line with the Opening up America Again guidelines, the three-phased approach, based on the advice of public health experts, to help state and local officials when reopening its economies, getting people back to work, and continuing to protect American lives.
The comprehensive plan was developed in consultation with EPA’s expertise on the safe and effective use of disinfectants against the SARS-CoV-2, the virus that causes COVID-19. The guidance offers a three-step process for preparing spaces for reopening:
- Develop a plan
- Determine what needs to be cleaned;
- Determine how areas will be disinfected; and
- Consider the resources and equipment needed.
- Implement the plan
- Clean visibly dirty surfaces with soap and water;
- Use the appropriate cleaning or disinfectant product; and
- Always follow the directions on the label.
- Maintain and revise the plan
- Continue routine cleaning and disinfection;
- Maintain safe practices; and
- Continue practices that reduce the potential for exposure.
EPA states that cleaning and disinfecting surfaces is an important, two-step process essential to any effort to reduce the risk of exposure to SARS-CoV-2, the virus that causes COVID-19.
- Clean: Use soap and water to remove germs, dirt, and impurities from surfaces. It lowers the risk of spreading infection.
- Disinfect: Use disinfectant products to kill germs on surfaces. By killing germs on a surface after cleaning, it can further lower the risk of spreading infection.
EPA has compiled a list of disinfectants for use against SARS-CoV-2, List N: Disinfectants for Use Against SARS-CoV-2, which include ready-to-use sprays, concentrates, and wipes. EPA emphasizes to follow the product label instructions and safety information, including leaving the product on the surface long enough to kill germs, rinsing off the product to avoid ingesting it, and putting the product out of reach of children right away.
EPA also states that it is important to avoid over-using or stockpiling disinfectants or personal protective equipment, which can result in shortages of critical products needed for emergencies. In the event that disinfectant products on the EPA list are not available, the guidance provides other techniques for disinfecting surfaces that are as effective in reducing the risk of exposure to SARS-CoV-2, the virus that causes COVID-19.
EPA’s guidance documents are available here.
Posted on February 20, 2020 by editorBy Heather F. Collins, M.S. and Barbara A. Christianson
On February 12, 2020, the U.S. Environmental Protection Agency (EPA) announced the availability of 11 products that have been approved for use to disinfect surfaces against the emerging multidrug-resistant fungus Candida auris (C. auris). C. auris can cause severe infections and spreads easily among hospitalized patients and nursing home residents. The 11 products are approved for use against C. auris to disinfect surfaces in hospitals, nursing homes, and other healthcare facilities, to help reduce patient infections. There were no antimicrobial pesticide products registered specifically for use against C. auris prior these new use registrations.
EPA worked in collaboration with the Centers for Disease Control and Prevention (CDC) and other federal partners to ensure that the products would be effective against C. auris. Previously, on October 16, 2019, EPA had granted public health exemptions under the provisions of section 18 of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) as amended, to the CDC, for uses of antimicrobial products, on hard, nonporous surfaces in healthcare settings for disinfection from C. auris.
The 11 products that are now registered for use against C. auris are:
- Avert Sporicidal Disinfectant Cleaner (EPA Reg. No. 70627-72);
- Blondie (EPA Reg. No. 67619-24);
- Dagwood (EPA Reg. No. 67619-25);
- Micro-Kill Bleach Germicidal Bleach Wipes (EPA Reg. No. 37549-1);
- Oxivir 1 (EPA Reg. No. 70627-74);
- Oxivir 1 Wipes (EPA Reg. No. 70627-77);
- Oxivir Wipes (EPA Reg. No. 70627-60);
- Oxycide™ Daily Disinfectant Cleaner (EPA Reg. No. 1677-237);
- Virasept (EPA Reg. No. 1677-226);
- Wonder Woman Formula B Germicidal Wipes (EPA Reg. No. 9480-12); and
- Wonder Woman Formula B Spray (EPA Reg. No. 9480-10).
Because there are few products with C. auris claims at this time, CDC and EPA have identified additional products that are effective against C. auris. Although these products do not yet have formal EPA-registered claims for C. auris, testing at CDC has confirmed they are effective against C. auris. The label on the product will not include instructions for C. auris. CDC guidance states to “follow the instructions provided for C. albicans, if included, or else follow those for fungicidal activity.” These products include:
- Oxivir TB Spray (EPA Reg. No. 70627-56); and
- PDI Super Sani-Cloth (EPA Reg. No. 9480-4).
The CDC Guidance further states that, if none of the above-listed products are available, or any of the EPA-registered products that are newly approved for the specific claims against C. auris, CDC recommends use of an EPA-registered hospital-grade disinfectant effective against Clostridioides difficile spores, because CDC believes these products have been used effectively against C. auris (List K).
Additional information on C. auris is available on EPA’s website and CDC’s website.
Posted on February 17, 2017 by Lynn L. BergesonBy Lynn L. Bergeson, Sheryl Lindros Dolan, and Margaret R. Graham
On February 17, 2017, the U.S. Environmental Protection Agency (EPA) announced that the Centers for Disease Control and Prevention (CDC) issued guidance revising its recommendation regarding controlling Candida auris (C. auris) infections in U.S. healthcare facilities. The CDC guidance now recommends a “thorough daily and terminal cleaning and disinfection” of patient rooms in which C. auris infection or colonization was present … with the use of an [EPA]-registered hospital-grade disinfectant effective against Clostridium difficile [(C. difficile)] spores.” The new guidance updates the CDC’s clinical alert on C. auris issued in June 2016 after receiving reports from international healthcare facilities that C. auris, “an emerging multidrug-resistant (MDR) yeast, [was] causing invasive healthcare-associated infections with high mortality.” Previously, CDC recommended use of an EPA-registered disinfectant with a fungal efficacy claim.
As EPA is responsible for regulating hospital disinfectants and other antimicrobial pesticides used in healthcare facilities, this updated guidance has particular interest and significance for registrants of hospital disinfectant products. EPA maintains a list of registered antimicrobial products effective against C. difficile (List K) and states that “Guidance to the companies that register antimicrobial products and seek label claims against C. auris is under development.”
|
