EPA Revises Guidance to Ensure Effectiveness of Antimicrobial Pesticides Against Candida auris

This original announcement was published by the EPA on October 15, 2021. Click here for more information.

 

The U.S. Environmental Protection Agency (EPA) has revised its guidance for evaluating the efficacy of antimicrobial pesticides against Candida auris (C. auris). 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.

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. 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 their 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.

Under the updated guidance issued today, 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 cases where the study initiation date is between Oct. 15, 2020, and Oct. 15, 2021. 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, the Agency recommends retesting with the more relevant strain (AR Bank #0385) identified in the updated guidance.

See the updated guidance for more information.

EPA Holds Online Pesticide Program Dialogue Committee Meeting in October

This original announcement was published by the EPA on October 8, 2021. Click here to learn more and register!

 

EPA Holds Online Pesticide Program Dialogue Committee Meeting in October

EPA’s Office of Pesticide Programs (OPP) will hold an online public meeting of the Pesticide Program Dialogue Committee (PPDC) on October 27-28, 2021.

At this meeting:

  • The PPDC workgroups on Pesticide Resistance Management, Farmworker and Clinician Training, Emerging Pathogens, and Emerging Technologies will report on their work and discuss their recommendations with the PPDC. Members of the PPDC will provide their perspectives on the workgroup reports.
  • OPP will provide updates on recent activities, accomplishments, and program changes.
  • Representatives from the National Pesticide Information Center, the Centers for Disease Control and Prevention (CDC), and EPA’s Office of Enforcement and Compliance Assurance (OECA) will present on science-based risk communication, the CDC’s Sentinel Event Notification System for Occupational Risk (SENSOR) Pesticide Program, and OECA’s Good Laboratory Practices Inspection Section.

Please visit the PPDC webpage for a link to register to attend the meeting. See the Federal Register Notice.

To provide comments during the meeting, request special accommodations or get more information, please contact Shannon Jewell at jewell.shannon@epa.gov or at (571) 289-9911 by October 19, 2021.

Now Available: Registration for upcoming IRIS Public Science Meeting (November 2021)

This original announcement was published by the EPA on September 30, 2021. Click here to register.

 

The U.S. Environmental Protection Agency’s (EPA) Health and Environmental Risk Assessment (HERA) National Research Program is announcing a virtual IRIS Public Science Meeting for November 9, 2021. The Integrated Risk Information System (IRIS) Program is convening the previously postponed IRIS Public Science Meeting to discuss the IRIS Assessment Plan associated with the unsuspended naphthalene assessment.

Should you wish to attend the meeting and/or provide oral public comment, register here. Program materials, including the assessment plan, can be found on the Public Science Meeting website. Interested stakeholders may view the public comment received on the naphthalene IAP by visiting Regulations.Gov (Docket no. EPA-HQ-ORD-2014-0527). While IRIS assessments are not associated with proposed rulemaking, Regulations.gov serves as both an internal portal to facilitate public comment and as a document repository for Federal government agencies.


Call for Nominations — Review of EPA’s 2021 Draft IRIS Formaldehyde Assessment

EPA’s HERA National Research Program is highlighting that an ad hoc committee of the National Academies of Sciences, Engineering, and Medicine (NAS) will provide the Environmental Protection Agency (EPA) with a review of EPA’s 2021 draft IRIS formaldehyde assessment. An ad hoc committee will assess whether the draft assessment adequately and transparently evaluated the scientific literature, used appropriate methods to synthesize the current state-of-the science, and presented conclusions regarding the hazard identification analysis and dose-response analysis of formaldehyde that are supported by the scientific evidence. The committee will not conduct its own hazard assessment of formaldehyde, nor will the committee address broader aspects of the IRIS Program.

Nominations for committee members and/or reviewers for this study are due by October 15, 2021. For more information regarding this peer review, visit the NAS website.

Now Available: Draft Supplement to the 2019 Integrated Science Assessment for Particulate Matter (PM ISA Supplement)

This original announcement was published by the EPA on September 30, 2021. Click here for more information!

 

Notice:  EPA’s Health and Environmental Risk Assessment (HERA) National Research Program is announcing for public comment and external peer review the release of the draft Supplement to the 2019 Integrated Science Assessment for Particulate Matter (PM). The HERA research program has been designed to develop and apply state-of-the-science research to characterize impacts on human and ecological systems – whether they result from exposure to single, complex, or multiple physical, chemical, or biological stressors – to support and improve EPA’s risk assessment and risk management decisions. Integrated Science Assessments (ISAs) fall under HERA’s Science Assessment Development Research Area which is focused on producing high quality, transparent, consistent, and scientifically-defensible assessment products to meet EPA’s diverse statutory and policy needs.

This draft Supplement represents a targeted evaluation of recent studies published since the literature cutoff date for the 2019 PM ISA. The 2019 PM ISA and this Supplement form the complete scientific record for the ongoing reconsideration of the primary (health-based) and secondary (welfare-based) National Ambient Air Quality Standards (NAAQS) for PM. The 2019 PM ISA and Supplement, in conjunction with additional technical and policy assessments, will inform EPA’s decisions on the reconsideration of the current NAAQS and the appropriateness of possible alternative standards.

The draft assessment is available for a 60-day public comment period, which ends on November 29, 2021. Written comments should be submitted to EPA-HQ-ORD-2014-0859 via Regulations.gov. Comments submitted to EPA, via the public docket, will be provided to the external peer review panel. The date and location of a public meeting for the external peer review panel will be specified in a separate Federal Register notice.

For more information on the PM ISA Supplement, including how to submit comments, please visit the Federal Register or the EPA ISA website. For more information on HERA, please see the program’s Strategic Research Action Plan.