Integrating Policy: Water, Endocrine Disruptors, and Pharmaceuticals
The links between policies on water and chemicals are straightforward but integrated policy is a challenge that needs to be addressed. The Strategic Approach to Integrated Chemicals Management (SAICM) has played an important role in bringing attention to emerging issues that cross these domains.
Two chemical groups recognized by SAICM that fall outside global agreements and have significant impacts on water, health, and biodiversity are endocrine disrupting chemicals (EDCs) and environmentally persistent pharmaceutical pollutants (EPPPs). SAICM recognized EDCs and EPPPs as emerging policy issues a decade ago, accelerating cooperative actions among governments and stakeholders to mobilize knowledge and awareness. EDCs and EPPPs are not only important topics for global governance on chemicals. Policy advancements addressing EDCs and EPPPs are also applicable to and can be strengthened by the voluntary commitments of the 2023 UN Water Conference, negotiations for a new international treaty on plastics and a science-policy body on chemicals and wastes, and the implementation of the Global Biodiversity Framework (GBF), among other decision-making forums.
EDC and EPPP Risks
Historically, the risks and harms of pollution have not been prioritized in policy agendas commensurate with their impact on the health of people and planet. Worldwide consumption and production patterns have pushed the planetary boundary for environmental pollutants past sustainability while at least 5,000 novel chemicals produced since 1950 are recognized to have nearly universal human exposure. Pollution contributes approximately 17-25% of the environmental burden of disease, or about 9 million deaths per year. This is a fraction of the amount of its sub-lethal harms that lead to a wide spectrum of diseases, many of which are not recognized.
In 2017, the global health community elevated the visibility of negative health outcomes from chemical pollution through the formation of a Lancet Commission on Pollution and Health, yet an assessment report five years later noted “strikingly little” progress within countries to address these challenges. In fact, the challenge is increasing according to the World Water Development Report 2023: globally, water use rises by 1% per year but, still, five of 11 target indicators for SDG 6 (clean water and sanitation) are not reported.
EDCs and EPPPs were recognized by SAICM as emerging pollutants of concern in 2012 at the third International Conference on Chemicals Management (ICCM3) and in 2015 at ICCM4, respectively, due to their health risks. Worldwide, nearly everyone is suspected to have EDCs in their blood. EDCs are also found in the blood of diverse species in many ecosystems, which creates specific risks for mammals, birds, fish, and some other species who have endocrine systems. Normal reproduction and development of current and future generations of humans and other species are jeopardized by EDCs. This is a risk that will grow with rising use of plastic – a major EDC source -, which is projected to triple by 2060.
The sub-lethal effects of EDCs are dangerous and long-lasting. EDCs alter natural mechanisms of development and normal physiologic function because they change the internal communication system – the hormone system – of the organism exposed, essentially resulting in a biological re-programming, de-programming, or mal-programming. They are also known to modify DNA regulation and expression, yielding heritable changes across multiple generations. In addition, EDCs are associated to secondary effects, such as increased likelihood of non-communicable diseases (NCDs).
Concentrations of EPPPs create low-dose drug mixtures that humans are exposed to in water, and at the same time, these substances can have complicated negative therapeutic impacts on other species. Drugs in the environment have the unintended consequence of having their intended effect on the physiology of other species. For example, antidepressants, analgesics, antimicrobials, and steroids like contraceptives alter behavior and feeding, renal function, natural decomposition of excrement, and feminization, fertility and fecundity, ultimately disturbing ecological relationships and life cycles. The intentional therapeutic design of pharmaceuticals also contributes to their persistence in ecosystems and risks to other species.
EDCs and EPPPs both have substantial negative impacts on water resources and water ecosystems. EDCs are found in diverse water ecosystems and in surface, ground, and drinking water. Many sectors contribute to the EDC “cocktails” in water resources because EDC production and use are central to agriculture (pesticides), houseware industry (plastics), electronics (plastics and heavy metals), cosmetics, and healthcare (plastics). EDCs also arise from industrial chemicals used to enhance other products, such as with flame retardant qualities. The exposure data on EDCs at the sectoral level can be staggering. For one, fruit and vegetable produce can carry dozens of endocrine disrupting residues from pesticides. Current data on a specific type of EDC with hydrophilic (water-loving) chemical properties, per- and polyfluoroalkyl substances (PFAs), show they are widespread across regions, and frequently detected in water regardless of proximity to point sources, carrying significant implications for public health. For instance, the European Environment Agency (EEA) observes that 14% of teenagers across nine countries have blood levels of PFAs above health guidance levels. Leading institutions generally conclude that the impacts of EDCs are underestimated. A focus on water pollution is important to the management of EDCs because, according to the Stockholm Convention on Persistent Organic Pollutants’ (POPs) Second Global Monitoring and Review, EDC concentrations in water serve as an important indicator to the effectiveness of policies to reduce their emissions.
Similarly, EPPPs mainly pollute water, contaminating surface water, groundwater, drinking water, and soil. The dominant emission pathway is urban wastewater discharge, with that from manufacturing, animal husbandry, and aquaculture also being significant. Findings from a report of 89 countries showed 992 active chemicals from pharmaceuticals or their transformation products are found in water and waste streams, and 703 of these were found in surface, ground, or drinking water. Another finding showed that 37 EPPPs exist in all five UN regions. At the same time, conclusions from a workshop on risks held by the World Health Organization (WHO) Regional Office for Europe concluded that no existing health-surveillance programmes are fully applicable for EPPPs.
EDCs and EPPPs slip through the cracks of existing environmental governance regimes. The risks of EDCs are well understood but constructing a regulatory framework that captures their complexity, prevalence, and life cycle in the environment is difficult. EDCs can contaminate soil, water, air, and food, and fall under numerous regulatory categories depending on what profession is assessing them. Under international environmental law they can be categorized as “POPs,” “hazardous waste,” “mercury products” and other “heavy metals,” “pesticides,” and “plastics.” In the health sector, they are discussed as “carcinogens,” “mutagens,” and “reprotoxicants.” Despite that EDCs link to a spectrum of governance instruments, and their global prevalence, major sources of EDCs are not being addressed at the global scale because no global instrument encompasses them comprehensively. Efforts at the sub-global and national level are similarly uneven and patchy. Thousands more chemicals are linked to endocrine disruption than the 1,400 currently documented as EDCs, and of those documented, less than 10% are being assessed and/or addressed through existing instruments and actions, worldwide.
A similar challenge exists for EPPPs, but for different reasons. Major multilateral environmental agreements (MEAs) addressing chemicals, namely the Stockholm Convention on POPs, the Basel Convention on Transboundary Movement of Hazardous Waste, the Rotterdam Convention on Prior Informed Consent (PIC), and the Minamata Convention on Mercury, explicitly exclude pharmaceuticals from consideration. The sheer volume of these substances in the environment warrants a more inclusive approach. In some high-income economies estimates suggest nearly 50% of the population uses pharmaceuticals at any given time. The cumulative outflow of pharmaceutical products in hospital and household water and waste streams is steadily growing but risk assessments are insufficient. For example, in the EU, more than 3,000 pharmaceuticals are distributed without an Environmental Risk Assessment (ERA).
Water policy should be a logical home for governance of EDCs and EPPPs, however in practice, there is a mismatch in scale. Most regulatory policies on water are at the local or regional level, or scoped for river basins, while the prevalence and distribution of EDCs and EPPPs are global and transboundary. Moreover, global health experts note that metrics for industrial water pollution were agreed as part of the SDGs but are underdeveloped. Under public health mandates, water and sanitation policies are not scoped to consider chemical pollutants comprehensively or, in some areas, prioritize water access over risks from chemical pollution. The WHO began a process of developing drinking water quality guidelines on PFAs in 2017.
SAICM mobilized a series of “cooperative actions” to stimulate progress on EDCs (2012) and EPPPs (2015), because a focus on research cannot alone be successful in driving policy action. In 2020, the UN Environment Programme (UNEP) issued ‘An Assessment Report on Issues of Concern: Chemicals and Waste Issues Posing Risks to Human Health and the Environment,’ in which it noted that despite some progress on EDCs and EPPPs, current actions were insufficient to address the global nature and/or full life cycle of these issues. In the report, UNEP identified a number of ways to develop and advance a landscape of governance approaches to EDCs, spanning agriculture policies, health and occupational policies, human rights, and the domains of biodiversity and climate change. UNEP also identified challenges and opportunities to shape the norms and policies in the sound management of EDCs:
- Bringing countries to the same level of awareness and knowledge, and ensuring regular periodicity of assessments and synthesis of scientific knowledge ready to be used in policy environments; and
- Bridging different approaches to assessing and managing EDCs, rectifying policy inconsistencies, data requirements, and joint assessments and strategies, with emphasis on the broad uptake of the Globally Harmonized System of Classification and Labelling of Chemicals (GHS).
UNEP also identified challenges to making progress on EPPPs that include addressing barriers in existing norms and policies:
- The scope of pharmaceuticals addressed is limited by terminology “environmentally persistent,” which does not capture, for instance, those that are pseudo persistent and bioaccumulate or those whose short-term impacts are irreversible. One way forward is to expand this scope with simple, general criteria.
- Pharmaceutical waste prevention needs to be stepped up because contamination is expensive and technically difficult. Stakeholders need to encourage pharmaceutical manufacturers to be more engaged in “green pharmacy” approaches along the value chain.
- Support for addressing negative impacts of pharmaceuticals is needed in developing countries and economies in transition and needs to be tailored to the pharmaceuticals most prevalent in local wastewater in those areas.
- The system of Environmental Risk Assessments (ERAs) needs to be re-visioned to capture the existing risk of total pollution load. Thousands of pharmaceutical products are distributed without ERAs and are measured in surface water at significant concentrations.
- Strengthening the engagement of pharmaceutical manufacturers and capturing the full life cycle of a pharmaceutical product in policy actions are important.
- Moving beyond a focus on knowledge to policy actions is needed. A package of instruments that includes marketing authorization, take-back unused/expired drug programs, and waste treatment, among others, are required.
One issue linked to EPPPs – the increasing risk and threat of “superbugs” – is drawing increasing attention worldwide. The multifaceted problem due to the use of antimicrobial drugs in human, veterinary, and livestock agriculture is a significant issue under EPPPs. According to a 2023 report, ‘Bracing for Superbugs,’ UNEP says minimizing pharmaceuticals is “critical” to preventing antimicrobial resistance (AMR) and ecotoxicity. Antibiotics, antivirals, fungicides, and disinfectants flow in wastewater, but a fraction have been assessed. The scale and interconnectedness of AMR water contamination calls for a comprehensive, multi-sectoral response, including ‘upstream’ and ‘downstream’ interventions as well as enhanced data collection and research. Solutions include improved prevention and reduction in overuse, especially in the agriculture sector, and improved water, sanitation, and hygiene (WASH) programmes.
Financing the sound management of EDCs and EPPPs
Major risks and major costs present a dual challenge for the sound management of EDCs and EPPPs and new attention is needed to highlight the long-term financial impacts of these pollutants. Arguments that pollution is not cost-effective are “flawed and obsolete,” according to health experts. At the same time, new investments in cost-benefit analyses to unveil and communicate hidden costs of pollution are essential.
A 2015 estimate of the cost of inaction on EDCs in Europe totals EUR 157 billion, and similarly, projections to pre-emptively manage the costs of antimicrobial resistance (AMR) are between USD 4 billion – 9 billion per year (upstream) and USD 13 billion – 47 billion per year (downstream). Another gap area is the disproportionate lack of funding in research and design for hazard analysis. In 2013, the EEA noted that “over the past decade” 1% of research funding went to hazards while 99% went to product development. Some stakeholders advocate for a 0.5% chemicals tax on the USD 2.3 trillion profit from production of basic chemicals.
Human rights dimension of EDCs and EPPPs management
The UN Special Rapporteur on Toxics views exposure of people to harmful substances without their prior informed consent as a human rights issue. The Rapporteur outlines the human rights obligations of states on pollution and toxics, including to establish monitoring programmes, assess major sources of exposure, and provide the public with accurate, accessible information about risks to health, and to not cause pollution or exposure to toxic substances that violate the right to a clean, healthy, and sustainable environment recently recognized by the UN General Assembly (UNGA). Specifically, the Rapporteur notes that the “application and interpretation of the right to a safe, clean, healthy and sustainable environment in the context of pollution and toxic substances should be guided by the principles of prevention, precaution, non-discrimination and non-regression, and the polluter pays principle.” The UN Special Rapporteur on the Human Environment further states that a non-toxic environment depends on safe, sufficient water and healthy aquatic ecosystems, which should be managed with water plans that take a rights-based approach.
Pollution is a major cause of environmental injustice, and gender equity is receiving increasing attention in this regard. The disproportionate exposure and risks women face leads some stakeholders to underscore the importance of gender-responsive chemicals management, while eight countries have invested in a multi-year project to assess the EDC toxicity on the female reproductive system. SAICM recognizes that information on chemicals associated to endocrine disruption should not be confidential.
Opportunities to promote sound management of EDCs and EPPPs
The recently concluded UN 2023 Water Conference created an opportunity to elevate the importance of sound management of EDCs and EPPPs. One key focus could be incorporating their consideration in voluntary commitments that make up the Water Action Agenda, which could, for instance, emphasize or specify quantitative goals on pollution, and the interlinkages of the human right to a clean, healthy, sustainable environment and the right to water and sanitation. The High-level Political Forum on Sustainable Development (HLPF) in July 2023 where SDG 6 will undergo in-depth review, as well as the SDG Summit in September could both bring much-needed attention to the issue of EDCs’ and EPPPs’ sound management.
In addition, 2023 will be a busy year with high potential to advance more comprehensive global chemical governance that includes emerging policy issues. SAICM – a multistakeholder and multi-sectoral policy framework established in 2006 to mobilize action until 2020 – will undergo a critical review to determine the sound management of chemicals and waste beyond 2020. Key events contributing to this review are the resumed fourth session of the Intersessional Process for Considering SAICM and the Sound Management of Chemicals and Waste Beyond 2020 (IP4.3) and ICCM5 – a body whose aim is to promote chemical safety worldwide and whose mandate includes considering a new instrument to follow SAICM. Both of these events have been delayed since 2020 and will convene in September 2023. These forums provide opportunities to directly promote the management of EDCs and EPPPs as issues of concern.
In addition, UNEP’s intergovernmental negotiating committee (INC) on plastics will reconvene to continue deliberation on the design of a new international legally-binding instrument (ILB). The meeting will focus on the substantive scope of the treaty and its implementation and the form of the global agreement to which countries could commit. Some governments propose that the treaty be scoped to consider both socioeconomic and environmental considerations of plastics, which is a way to ensure space to consider EDCs and EPPPs under the health dimension of socioeconomic concerns.
The Open-ended Working Group for a science-policy panel for chemicals, waste, and pollution will also resume to advance discussion on the scope and concept of the new panel. The panel aims to provide policy-relevant scientific advice, and these talks provide another ripe moment to ensure that the mandate of the panel is broad enough to include impacts of EDCs across exposure routes (air, water, soil, food, and chemicals in products) and also explicitly include pharmaceuticals. The innovative horizon-scanning feature proposed for this panel is important for tackling emerging issues and facilitating early warning. The updated WHO report on the State of Science on Endocrine Disrupting Chemicals since 2012 is underway and anticipated prior to the sixth session of the UN Environment Assembly (UNEA) in 2024. Consideration for how the global health field can incorporate EDCs’ and EPPPs’ monitoring and actions to address them, such as through WASH programmes, would be a valuable chapter.
Other international forums and implementation actions provide additional opportunities to ensure water pollution, EDCs, and EPPPs are appropriately addressed and regulated at the global level. There are a number of biodiversity policy spaces that can strengthen uptake and capacity building for chemicals. GBF target 7 – to “reduce pollution risks and the negative impact of pollution from all sources, by 2030, to levels that are not harmful to biodiversity and ecosystem functions and services, considering cumulative effects,” including by halving nutrient loss and the risk of pesticide and highly hazardous chemicals, and by working towards eliminating plastic pollution – provides important synergies to chemicals governance spaces. Specific mention of water pollution from EDCs and EPPPs can be incorporated into updates of National Biodiversity Strategies and Action Plans (NBSAPs), which are currently underway. Development of One Health Action Plans is another vehicle where EDCs and EPPPs are relevant, such as within management strategies for antimicrobial drugs.
A renewed focus on gaps in national implementation and agenda setting is a way to take up global health recommendations. A 2022 Lancet Commission on pollution and health progress report on national water governance underlined the importance of cross-sectoral approaches to pollution control policies. The report observed that “ministries of health continue to prioritise infectious diseases and disease treatment, leaving pollution prevention to the ministries of environment, which usually have less power and less funding than ministries of health,” and further noted the absence of leadership from powerful ministries of finance, urban development, and energy.
Advancing effective pollution control for water resources, EDCs, and EPPPs will require the involvement of the health sector at the national level, particularly in the development of evidence reports, action plans, and communication. Some countries are making progress on EDCs, including Belgium, France, Japan, and Malaysia, though a recent analysis of regulatory approaches points to major technical barriers, such as the in vivo evidence requirement to demonstrate EDCs’ adverse effects. On pharmaceuticals, the Netherlands, Sweden, and China have developed progressive approaches. However, significant imbalance exists in the assessment and monitoring of chemicals, including EDCs and EPPPs, across regions. The Lancet report offers several recommendations to develop health sector involvement, including:
- Establishing monitoring and control systems on different forms of exposure, such as developmental toxicity, reproductive toxicity, immunotoxicity, the effects of long-term low-level exposures, and the health risks of chemical mixtures, such as by building on hazard identification models;
- Incorporating pollution prevention into development strategy frameworks;
- Strengthening media attention to topics relating to pollution and health;
- Including modern pollution prevention in multilateral development institutions’ country strategy frameworks;
- Linking pollution to planning for noncommunicable disease, climate change, biodiversity, food, and agriculture, and making pollution a more robust component of the One Health approach and in dialogues on planetary health; and
- Identifying and mapping pollution exposures particularly in low-income and middle-income countries.
A stronger mention of pollution in the Global Action Plan for the Prevention and Control of Non-Communicable Diseases would provide top-down support to national planning.
UNEP’s Assessment Report on Issues of Concern concluded by highlighting looking not only at risks to human health and the environment, but also at the links between chemicals and waste and other environmental and societal priorities. The year 2023 offers many doors to improving the global best practices on emerging issues in chemicals governance.
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This document has been developed within the framework of the Global Environment Facility (GEF) project ID: 9771 on Global Best Practices on Emerging Chemical Policy Issues of Concern under the Strategic Approach to International Chemicals Management (SAICM). This project is funded by the GEF, implemented by UNEP, and executed by the SAICM Secretariat. The International Institute for Sustainable Development acknowledges the financial contribution of the GEF to the development of this policy brief.
This Policy Brief is the fourth in a series featuring cross-cutting topics relating to the sound management of chemicals and waste. It was written by Liz Willetts, IISD Earth Negotiations Bulletin (ENB) Team Leader and Senior Writer. The series editor is Elena Kosolapova, Senior Policy Advisor, Tracking Progress Program, IISD.
- Fifth Meeting of the International Conference on Chemicals Management (ICCM5)
- UN 2023 Water Conference