Science‐based Targets for Antibiotics in Receiving Waters from Pharmaceutical Manufacturing Operations

• Published in: Integrated environmental assessment and management Vol. 15; no. 3; pp. 312 - 319
• Main Authors: Tell, Joan, Caldwell, Daniel J, Häner, Andreas, Hellstern, Jutta, Hoeger, Birgit, Journel, Romain, Mastrocco, Frank, Ryan, Jim J, Snape, Jason, Straub, Jürg Oliver, Vestel, Jessica
• Format: Journal Article
• Language: English
• Published: United States Blackwell Publishing Ltd 01.05.2019; John Wiley and Sons Inc
• Subjects: Anti-Bacterial Agents - analysis; Antibiotic; Antibiotic resistance; Antibiotics; Antimicrobial agents; Antimicrobial resistance; Antimicrobial resistance (AMR); Brief Communication; Discharge; Drug Industry; Environmental Monitoring - methods; Frameworks; Industrial Waste - analysis; International organizations; Manufacturing; Manufacturing industry; Pharmaceutical industry; Pharmaceutical resistance; Pharmaceuticals; PNEC; Receiving waters; Stewardship; Toxicity; Waste Water - analysis; PNEC; Antibiotic; Antimicrobial resistance (AMR); Pharmaceutical resistance; Antibiotic resistance
• ISSN: 1551-3777; 1551-3793
• DOI: 10.1002/ieam.4141

ABSTRACT In 2016, the United Nations declared the need for urgent action to combat the global threat of antimicrobial resistance (AMR). In support of this effort, the pharmaceutical industry has committed to measures aimed at improving the stewardship of antibiotics both within and outside the clinic. Notably, a group of companies collaborated to specifically address concerns related to antibiotic residues being discharged from manufacturing sites. In addition to developing a framework of minimum environmental expectations for antibiotic manufacturers, science‐based receiving water targets were established for antibiotics discharged from manufacturing operations. This paper summarizes the holistic approach taken to derive these targets and includes previously unpublished, company‐generated, environmental toxicity data. Key Points A recommended approach for assessing the risks from antibiotic manufacturing discharges is presented that considers both environmental endpoints and antimicrobial resistance. Also included are previously unpublished industry data on environmental toxicity of antibiotics.