Charles Tyler owns this image and gave permission for use on Pressgang article

Manufacturing discharges tend to have some of the highest antibiotic concentrations in the environment but they are not regulated by any laws.

Global antibiotic manufacturing discharge limits guided by Exeter researchers

The Antimicrobial Resistance (AMR) Industry Alliance has adopted the recommendations made by Exeter scientists for the setting of antibiotic manufacturing discharge targets around the globe.

The recommendations for the environmental risk assessment of antibiotics, advocated in a recent research paper by Exeter researchers1, Gareth Le Page and Charles Tyler, has guided the AMR Industry Alliance in setting antibiotic manufacturing discharge targets across the globe and delivering on the United Nations Industry Roadmap on AMR.

Manufacturing discharges tend to have some of the highest antibiotic concentrations in the environment but they are not regulated by any laws. Thus, setting protection targets for these discharges is important to mitigate the risks antibiotics pose to environmental and human health. The approach adopted ensures that both environmental health and human health (via the development of antimicrobial resistance) are considered when setting protection targets for antibiotic manufacturing discharges.

“It is fantastic to see some of my PhD research being applied by the global pharmaceutical industry as part of the commitments they made to the United Nations in 2016. It is important that we ensure that both our environment and ecological resources are protected as well as the protection against antimicrobial resistance development” said Gareth Le Page.

AMR has been declared a ”major threat to public health” by the World Health Organisation2 and predicted to cost 10 million lives a year by 20503. In 2016 the United Nations called for governments and industry sectors to take action against AMR. The AMR Industry Alliance was formed in response to this (consisting of over 100 leading biotech, diagnostic, generic and research-based pharmaceutical companies) and tasked with co-ordinating the industry response to the threat of AMR development.

Charles Tyler, principal investigator said ‘ This work on AMR was commissioned by AstraZeneca, with whom we have had a long standing research partnership, and it is a great example of how working together with industry can help us translate our research work to more effectively support environmental protection and adoption of best practice in an unregulated area. I am delighted to see this outcome’

Jason Snape, Environmental Director within AstraZeneca said ‘We partnered with internationally renowned scientists at the University of Exeter to help us establish science-driven, risk-based targets for antibiotic-containing discharges. We are delighted that the wider AMR Industry Alliance has chosen to follow the approach that we published. This also demonstrates the significant impact that early career PhD students can have on science-based policy. The holistic approach we advocated gave equal weight to environmental and human health, this was critical as the most sensitive environmental species to antibiotics are those we rely on to fix carbon dioxide from our atmosphere.’

An analysis of species sensitivity to antibiotics in this research has also helped to guide the development of a tailored environmental risk assessment (ERA) approach for antibiotics by the European Medicines Agency in their ERA guidance update that is currently under consultation. The ERA guideline has proposed removing the requirement to test the impact of antibiotics on fish. Our research demonstrated that fish are far less sensitive to antibiotics compared with bacteria and microalgae, and do not drive the protection limits derived in ERA. If adopted, this will avoid unnecessary fish testing in the registration of antibiotics, in accordance the principles of the 3Rs (Replacement, Reduction and Refinement) for animal testing.

Article written by: Gareth Le Page, Biosciences Pressgang

Date: 22 January 2019

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