Document Ob0QQNapQ7LE1Owaej2DLpVp

RSC Policy Position Risk-based regulation for per-and polyfluoroalkyl substances (PFAS) FRSC ERT CChem Lead Policy Advisor - Chemicals Policy, RSC 1 PFAS Global 24 March 2022 Uses of PFAS PFAS play an important role in some vital products that improve quality and longevity of life. 2 https://www.rsc.org/new-perspectives/sustainability/sustainable-chemicals-strategy/ https://www.rsc.org/globalassets/04-campaigning-outreach/tackling-the-worlds- 3 challenges/environment/rsc_principles_for_chemicals_in_the_environment.pdf What is the real concern about harms from PFAS? PFOA Concerns from evidence around the world relating to PFAS pollution are valid C8 Perfluorooctanoic acid Localised PFAS pollution events linked to health effects: high cholesterol, ulcerative colitis, thyroid disease, testicular cancer, kidney cancer and pregnancy-induced hypertension. What are everyday exposures? and risks? We don't know enough. Obligation to prevent problems for future generations as per the UN Sustainable Development Goals Over decades - unchecked expansion >4700* persistent PFAS with little to no safety data generated Are all PFAS toxic to humans and wildlife via bioaccumulation? We don't know. PFAS must be regulated (reviewed and if necessary, controlled) urgently, to prevent a potentially damaging and intractable issue now and for the next generations. *figure according to EU sources 4 What are the key scientific challenges for evaluating risks from PFAS? If only a Safe & Sustainable by Design approach had been taken 40, even 10 or 20, years ago. This topic has grown into being one of the most complex and seemingly intractable toxicological challenges of our day, in terms of how to generate exposure and toxicology evidence to inform risk assessment. i) Data gaps and unknowns are extensive re: toxicology for hundreds of PFAS in global use; (N.B. safety data are not required when substances are used at low tonnage <1tpa in REACH or exempt as polymers with low bioavailability). ii) Sparse data on real exposure levels to PFAS (in water, environmental species and in humans) makes assessing risk a challenge iii) Addressing these scientific gaps using traditional toxicology approaches for individual PFAS - too costly, take decades and involve tens of thousands of animals 5 What are the key scientific challenges for evaluating risks from PFAS? Continued iv) Degree of Urgency to Know and Most Relevant Application of Scientific Resources To guide the science in the most impactful way, a collaborative steer is needed from wider society to focus efforts on those of the 4700 PFAS that are most important for the future benefit of society. To evaluate the risk:benefit outcomes for the range of PFAS use scenarios urgent targeted investment in skills development and new scientific approaches are needed e.g. new approach methods (NAMs) (see US EPA and US NTP work on PFAS data generation) and national environmental (bio)monitoring programmes - to help evaluate true scale of risk and potentially new risk-based paradigms to integrate new types of data We need a regulatory framework in which to evaluate the new types of data We need global collaboration to share data and harmonise our understanding of the real issues Persistence only - low level of new science needed - considerable consequences for society Risk-based - considerable scientific programme and the resources to implement a new way 6 PFAS-specific regulation: The building blocks and potential outcomes of a science-informed, risk-based framework for action How regulatory action and scientific efforts can evolve hand-in-hand, as part of a defined framework - to support urgent and effective risk-based control of those PFAS that are both persistent AND toxic Concept of a `PFAS Jury' - a citizens' forum to help government decide which PFAS-containing products are the most important to society and which should have a scientific risk assessment/ risk management evaluation 7 A proposed framework for risk-based PFAS regulation A `traffic-light' decision-tree approach https://www.rsc.org/globalass ets/04-campaigningoutreach/tackling-the-worldschallenges/environment/rsc_p rinciples_for_chemicals_in_th e_environment.pdf An approach to best direct the science is needed. Grouping/read-across applied - group by function? - group by hazards? - group by exposures? 8 10-step framework - Use of read-across (RAX) in Next-Generation Risk Assessment Alexander-White et al (2022) Reg Tox Pharm 129:105094. doi: 10.1016/j.yrtph.2021.105094. PMID: 34990780. Acknowledgement: Work funded by Cosmetics Europe Long-Range Science Strategy (LRSS) Programme Concepts and potential approaches from other areas that could be applicable to PFAS? 10 Key Messages Government, Science and Society-led criteria for prioritising action on PFAS (Government working with industry, academia, NGOs and a Citizens' PFAS Jury) A new pragmatic and proportionate way of performing a risk assessment (Application of New Approach Methods in Toxicology/(Bio)monitoring/Grouping Approaches/Risk paradigms) Blanket bans/restrictions on all PFAS on persistence alone is not a realistic option - takes less scientific resource but could have massive unintended consequences for society - the level of industry and societal backlash to policy based on persistence alone could be too high - in reality leading to postponement of any real action to reduce PFAS pollution. Doing nothing is not an option - good evidence of the toxicity of some PFAS, gives due cause for concern and we must protect public health and environmental species now and for future generations. We need a Sound Chemicals Management Framework using Science-informed Risk-Based Regulation 11 RSC `Burlington Consensus', January 2022 https://www.youtube.com/watch?v=YaTaMmZBnv4 Will PFAS be on the international UNEP agenda? "We need a global science panel for chemicals and waste and pollution prevention" 2 March 2022 United Nations Environment Assembly UNEA5 agreed!! PFAS pollution is a global issue and knows no boundaries 12 Thank you Full RSC policy position at https://www.rsc.org/globalassets/22-newperspectives/sustainability/a-chemicals-strategy-for-a-sustainablechemicals-revolution/pfas-policy-position-dec-2021.pdf 13