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EPA (part 5): Interagency Framework on AMR Risks of Antibacterial and Antifungal Pesticides

This is the fifth of a 5-part newsletter series. There is an initial 27 Sep 2023 newsletter introducing the EPA concept note, a second (28 Sep 2023) newsletter that expands on the EPA concept note, a third (12 Jan 2024) newsletter about ending the use of streptomycin spray on citrus crops, and a 4th newsletter (27 Jan 2024) containing some additional resources.

Dear All,

Excitingly, the US EPA (Environmental Protection Agency) has now finalized a framework for reviewing the AMR (resistance) risks of antibacterial and antifungal pesticides. Here’s a summary to get you started:

  • When used in crop or animal agriculture, antibacterials and antifungals fall under the regulation for pesticides provided by FIFRA (the Federal Insecticide, Fungicide, and Rodenticide Act).
  • FIFRA requires that use of the pesticide according to label specifications will not generally cause “unreasonable adverse effects on the environment” which are in turn defined to mean
    • “(1) any unreasonable risk to man or the environment, taking into account the economic, social, and environmental costs and benefits of the use of any pesticide, or
    • “(2) a human dietary risk from residues that result from a use of a pesticide in or on any food inconsistent with the standard under section 408 of the Federal Food, Drug, and Cosmetic Act.”
  • The heart of the new framework is that:
    • “EPA, in collaboration with its interagency partners, is establishing a new workgroup, the Interagency Drug and Pesticide Resistance and Efficacy Workgroup (IDPREW).
    • “IDPREW’s goal is to provide expert opinion, using a weight-of-evidence approach, on resistance issues involving antifungal or antibacterial pesticides, when requested by EPA, and potential interactions with medically important human or animal drugs.
    • “EPA will chair this workgroup. Initially, the workgroup will be comprised of several members with appropriate subject matter expertise from EPA, CDC, FDA, and USDA.”
    • “EPA will convene the IDPREW when there is available information that indicates a pesticide either proposed for a new registration or undergoing registration review may impact the efficacy of a human or animal antibacterial or antifungal drug.”
  • The commentary that introduces the new framework is fascinating:

Well done by EPA and its collaborators! There is no perfect solution to the tensions between human and agricultural use of antibacterials and antifungals, but we do need to be analyzing the issues. And there is also the question of environmental use — and here we even have a new training course and guidance document from WHO (see also the very last section of the future meetings list at the end of this newsletter).

Onward! With all best wishes, –jr

John H. Rex, MD | Chief Medical Officer, F2G Ltd. | Operating Partner, Advent Life Sciences. Follow me on Twitter: @JohnRex_NewAbx. See past newsletters and subscribe for the future: https://amr.solutions/blog/. All opinions are my own.

For more details, here are additional links (including CDC’s email alert):

  • The new framework, a collaborative interagency project from EPA, CDC, FDA, USDA, and the White House Office of Science and Technology Policy
  • Prior AMR.Solutions newsletters on the background to this process
  • CDC’s very concise email alert is reproduced it here in its entirety:
    • “The Environmental Protection Agency (EPA) recently finalized its framework for expanding federal collaboration on the review of antibacterial and antifungal pesticides. EPA developed the draft framework in coordination with the U.S. Department of Health and Human Services (including the Centers for Disease Control and Prevention and the Food and Drug Administration), the U.S. Department of Agriculture, and the White House Executive Office of Science and Technology Policy.
    • “This framework is intended to strengthen how the U.S. Government fully considers potential impacts of the use of some pesticides on the efficacy of medically important human and animal antibacterial and antifungal drugs.
    • “The EPA shared a related concept note for public comment in late 2023, and earlier this year the public had the opportunity to provide input on the draft framework.  
    • “This framework describes the EPA’s plan to establish the Interagency Drug and Pesticide Resistance and Efficacy Workgroup (IDPREW), which will convene to review information about a pesticide that has the potential to cause resistance to a medically important human or animal antibacterial or antifungal drug. When EPA drafts risk assessments for antibacterial and antifungal pesticides covered by the framework, it expects to consult with the IDPREW to seek input on the draft assessments. EPA and federal partners have also established a memorandum of understanding to facilitate information sharing for the IDPREW.
    • “Follow us at @CDC_AR on X (formerly Twitter) to stay up to date on antimicrobial resistance resources, activities, and tools. Thank you for your partnership.”

Current funding opportunities

  • ENABLE-2 has continuously open calls for both its Hit-to-Lead program as well as its Hit Identification/Validation incubator. Applicants must be academics and non-profits in Europe due to restrictions from the funders. Applications are evaluated in cycles … see the website for details on current timing for reviews. 
  • CARB-X has open calls at intervals that span four areas: (i) Therapeutics for Gram-Negatives, (ii) Prevention for Invasive Disease, (iii) Diagnostics for Neonatal Sepsis, and (iv) Proof-Of-Concept for Diagnosing Lower-Respiratory-Tract Infections. See this 6 Mar 2024 newsletter for a discussion of the call and go here for the CARB-X webpage on the call. There are multiple opportunities to submit — see the CARB-X webpage for details.
  • BARDA’s long-running BAA (Broad Agency Announcement) for medical countermeasures (MCMs) for chemical, biological, radiological, and nuclear (CBRN) threats, pandemic influenza, and emerging infectious diseases is now BAA-23-100-SOL-00004 and offers support for both antibacterial and antifungal agents (as well as antivirals, antitoxins, diagnostics, and more). Note especially these Areas of Interest: Area 3.1 (MDR Bacteria and Biothreat Pathogens), Area 3.2 (MDR Fungal Infections), and Area 7.2 (Antibiotic Resistance Diagnostics for Priority Bacterial Pathogens). Although prior BAAs used a rolling cycle of 4 deadlines/year, the updated BAA released 26 Sep 2023 has a 5-year application period that ends 25 Sep 2028 and is open to applicants regardless of location: BARDA seeks the best science from anywhere in the world! See also this newsletter for further comments on the BAA and its areas of interest.
  • HERA Invest was launched August 2023 with €100 million to support innovative EU-based SMEs in the early and late phases of clinical trials. Part of the InvestEU program supporting sustainable investment, innovation, and job creation in Europe, HERA Invest is open for application to companies developing medical countermeasures that address one of the following cross-border health threats: (i) Pathogens with pandemic or epidemic potential, (ii) Chemical, biological, radiological and nuclear (CBRN) threats originating from accidental or deliberate release, and (iii) Antimicrobial resistance (AMR). Non-dilutive venture loans covering up to 50% of investment costs are available. A closing date is not posted insofar as I can see — applications are accepted on a rolling basis; go here for more details.
  • The AMR Action Fund is open on an ongoing basis to proposals for funding of Phase 2 / Phase 3 antibacterial therapeutics. Per its charter, the fund prioritizes investment in treatments that address a pathogen prioritized by the WHO, the CDC and/or other public health entities that: (i) are novel (e.g., absence of known cross-resistance, novel targets, new chemical classes, or new mechanisms of action); and/or (ii) have significant differentiated clinical utility (e.g., differentiated innovation that provides clinical value versus standard of care to prescribers and patients, such as safety/tolerability, oral formulation, different spectrum of activity); and (iii) reduce patient mortality. It is also expected that such agents would have the potential to strongly address the likely requirements for delinked Pull incentives such as the UK (NHS England) subscription pilot and the PASTEUR Act in the US. Submit queries to contact@amractionfund.com.
  • INCATE (Incubator for Antibacterial Therapies in Europe) is an early-stage funding vehicle supporting innovation vs. drug-resistant bacterial infections. The fund provides advice, community, and non-dilutive funding (€10k in Stage I and up to €250k in Stage II) to support early-stage ventures in creating the evidence and building the team needed to get next-level funding. Details and contacts on their website (https://www.incate.net/).
  • These things aren’t sources of funds but would help you develop funding applications
    • AiCuris’ AiCubator offers incubator support to very early stage projects. Read more about it here.
    • The Global AMR R&D Hub’s dynamic dashboard (link) summarizes the global clinical development pipeline, incentives for AMR R&D, and investors/investments in AMR R&D.
    • Diagnostic developers would find valuable guidance in this 6-part series on in vitro diagnostic (IVD) development. Sponsored by CARB-X, C-CAMP, and FIND, it pulls together real-life insights into a succinct set of tutorials.
  • In addition to the lists provided by the Global AMR R&D Hub, you might also be interested in my most current lists of R&D incentives (link) and priority pathogens (link).

John’s Top Recurring Meetings
Virtual meetings are easy to attend, but regular attendance at annual in-person events is the key to building your network and gaining deeper insight. My personal favorites for such in-person meetings are below. Of particular value for developers are the AMR Conference and the ASM-ESCMID conference. Hope to see you there!

  • 17-20 Sep 2024 (Porto, Portugal; virtual attendance is possible): ASM/ESCMID Joint Conference on Drug Development to Meet the Challenge of Antimicrobial Resistance. Go here to register!
  • 16-20 Oct 2024 (Los Angeles, USA): IDWeek 2024, the annual meeting of the Infectious Diseases Society of America. Go here for details.
  • 25-26 February 2025 (Basel, Switzerland): The 9th AMR Conference 2025. Go here to register! 
  • 11-15 April 2025 (Vienna, Austria): ESCMID Global 2025, the annual meeting of the European Society for Clinical Microbiology and Infectious Diseases. Go here for details. 

  Upcoming meetings of interest to the AMR community:

  • 16-20 Oct 2024 (Los Angeles, USA): IDWeek 2024, the annual meeting of the Infectious Diseases Society of America. See Recurring Meetings list, above. 
  • 16 Oct 2024 (virtual and in-person, 10a-1p ET): FDA’s Rare Disease Innovation Hub, in collaboration with the Reagan-Udall Foundation will discuss how the recently announced Rare Disease Innovation Hub can engage and prioritize its work. This may seem somewhat remote, but could this have implications for rare infections? Hmm! Attend if you can! Go here for the meeting’s webpage.
  • 19-27 Oct 2024 (Annecy, France, residential in-person program): ICARe (Interdisciplinary Course on Antibiotics and Resistance). Now in its 8th year, Patrice Courvalin directs the program with the support of an all-star scientific committee and faculty. The resulting soup-to-nuts training covers all aspects of antimicrobials, is very intense, and routinely gets rave reviews! Seating is limited, so mark your calendars now if you are interested. Applications open in March 2024 — go here for more details.
  • 22-24 Oct 2024 (Belgrade, Serbia): Ecraid/ESCMID postgraduate course “Better methods for clinical studies in infectious diseases and clinical microbiology”. Go here to register by 29 Sep 2024.
  • 4-5 Dec 2024 (in person, Washington, DC): “Fungal Dx 2024: Fungal Diagnostics in Clinical Practice” is a 2-day in-person workshop organized by ISHAM‘s Fungal Diagnostics Working Group. The program and registration links are available at https://fungaldx.com/; the agenda is comprehensive and features an all-star global list of speakers.
  • 4-5 Feb 2025 (online, 1-5p GMT timing on both days): Antimicrobial Chemotherapy Conference by GARDP and BSAC in collaboration with CEPID-ARIES and Fiocruz. Now in its 6th year, the free program offers a good review of antimicrobial R&D, ranging from drug discovery to preclinical and clinical activities. Go here to register; the abstract deadline is 15 Nov 2024.
  • 11-15 April 2025 (Vienna, Austria): ESCMID Global 2025, the annual meeting of the European Society for Clinical Microbiology and Infectious Diseases. See Recurring Meetings list, above.

Noteworthy self-paced courses and training materials (this is a new section — comments on it would be appreciated!):

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