11
Jan
FDA Cites Resistance to Medically Important Antimicrobials as Critical Health Issue
(Beyond Pesticides, January 11, 2024) In a move to safeguard public and animal health, the U.S. Food and Drug Administration (FDA) warned nine manufacturers and distributors in December last year to stop selling unapproved and misbranded antimicrobial animal drugs, with the director of FDA’s Center for Veterinary Medicine, Tracey Forfa, explaining to the public that “inappropriate use of medically important antimicrobials contributes to the development of antimicrobial resistance, which affects both human and animal health.â€Â This action and announcement exhibit a higher degree of concern about antimicrobial resistance—understood as a growing worldwide pandemic—than the history and ongoing inaction by the U.S. Environmental Protection Agency (EPA)—resulting in the allowance of widespread nonmedical uses of antibiotics in agriculture and on synthetic (or artificial) turf. Contrary to broad scientific understanding, EPA told a federal appeals court last year that, “There is no data that antibiotic use in agriculture leads to the presence of antibiotic resistance in bacteria of human health concern,†and that “[a]t the present time, there is little evidence for or against the presence of microbes of human health concern in the plant agricultural environment.†The issue of resistance discussed in the scientific literature concerns reduced susceptibility to clinically important antimicrobials, including antibiotics, due to either cross-resistance or co-resistance mechanisms.Â
The FDA enforcement action highlights the growing concern over antimicrobial resistance (AMR), a critical issue that Beyond Pesticides has reported on extensively, especially as related to horizontal gene transfer (the movement of antibiotic-resistant bacteria throughout the environment, ultimately making their way to people, as medically necessary drugs become ineffective). The illegal marketing of these drugs for minor species, including aquarium fish and pet birds, featuring medically important antimicrobials such as amoxicillin, penicillin, tetracycline, and erythromycin, violates FDA regulations.Â
While the uses in the FDA warning are limited, the agency used the opportunity to highlight the importance of the AMR issue. AMR is an escalating global health crisis that affects humans and animals alike. When pathogenic microorganisms become resistant to antimicrobials designed to kill them, the consequences can be severe, leading to infections that are harder to treat and more likely to spread. Previous coverage of this issue by Beyond Pesticides has discussed how the use of antimicrobials, including antibiotics, in agriculture, synthetic turf management, and medicine contribute to this resistance, turning what were once easily treatable infections into serious health threats. The use of antimicrobials in artificial turf exemplifies a nonmedical use that results in frequent exposure to children and others playing on antimicrobial-treated surfaces. In November, Beyond Pesticides reported, “A builder of sports facilities, American Athletic, states, “Beyond surface cleaning, the artificial turf should be sanitized weekly or monthly to protect the players’ and coaches’ health. This disinfection requires special solvents, cleansers, and anti-microbial products to remove invisible particles and bacterial growth. You should strive to sanitize the field after every game and throughout the school day if it’s used for physical education classes.â€Â
A 2020 scientific peer-reviewed article in Revista Panamericana de Salud Publica (Pan American Journal of Public Health)—a publication of the Pan American Health Organization, From environment to clinic: the role of pesticides in antimicrobial resistance, finds the following: “This report draws attention to molecules, rather than antibiotics, that are commonly used in agrochemicals and may be involved in developing AMR in non-clinical environments, such as soil. This report examines pesticides as mediators for the appearance of AMR, and as a route for antibiotic resistance genes and antimicrobial-resistant bacteria to the anthropic environment. Available evidence suggests that the natural environment may be a key dissemination route for antibiotic-resistant genes. Understanding the interrelationship of soil, water, and pesticides is fundamental to raising awareness of the need for environmental monitoring programs and overcoming the current crisis of AMR.â€Â Â
The study goes on: “Soil microbiota serves as an early contributor to AMR and a reservoir of genes for resistance to clinical pathogens. Metagenomics studies have identified an exchange of antibiotic resistance genes (ARG) between environmental bacteria and clinical pathogens (5). Multidrug-resistant (MDR) soil bacteria also contain genes for resistance to the main classes of antibiotics, such as aminoglycosides, amphenicols, β-lactams, sulfonamides, and tetracycline.â€Â
As the American Society for Microbiology (ASM) noted in its December 13, 2023 letter to Environmental Protection Agency, ASM Responds to Environmental Protection Agency on Antimicrobial Resistance Assessment Framework about EPA’s proposed Antimicrobial Resistance Assessment Framework, “Antimicrobial resistance (AMR) is a top public health threat and one of our most daunting challenges. AMR is associated with the deaths of 4.95 million people in 2019 and is projected to cause 10 million deaths by 2050. Each use of an antimicrobial drug or agent, whether used to treat disease in humans, animals, or crops, contributes to antimicrobial resistance. As existing antimicrobial agents decline in effectiveness, infections will be more difficult and expensive to treat and epidemics harder to control.â€Â
The FDA, in its announcement, links to its simply stated page entitled Antimicrobial Resistance: “When microorganisms become increasingly resistant to antimicrobial drugs, the drugs become less effective at slowing or stopping the growth of the microorganisms. This makes it more difficult to treat infections in people and animals. When antimicrobials are used excessively or inappropriately, the rate of this resistance grows.â€Â
The scientific literature and many recommendations abound for strategies and progress on AMR, including banning medically important antibiotics in agribusiness and promoting consumer (and business) awareness and action. Beyond Pesticides endorses these strategies, but insists that a genuine solution must include a systemic change through the transition to organic agriculture, recognizing the health benefits it provides. Beyond Pesticides’ databases, including Gateway on Pesticide Hazards and Safe Pest Management and Pesticide-Induced Diseases Database, provide advocates with science-based information that informs the urgent need to shift to organic management practices in addressing existential health, biodiversity, and climate crises.Â
All unattributed positions and opinions in this piece are those of Beyond Pesticides.Â
Sources:
FDA NEWS RELEASE: FDA Warns Nine Manufacturers, Distributors of Unapproved Antimicrobials for Animals; FDA warns Chewy, others about antimicrobials in pet drugs
Agricultural Uses of Antibiotics Escalate Bacterial Resistance: Organic leads in prohibiting antibiotic use, Beyond Pesticides’ Pesticides and You, Winter 2016-2017; American Society for Microbiology letter to Environmental Protection Agency
