Environmental risk assessment in agro-ecosystems: Revisiting the concept of receiving environment after the EFSA guidance document.

The environmental risk assessment (ERA) for genetically modified plants (GMPs) is a prerequisite for commercial approval of these new varieties according to regulatory systems worldwide. The first country to regulate GM crops was the USA and the issue of possible environmental impacts was based on the principles used in risk assessment of pesticides. Two main pillars of this approach are the use of surrogate species for testing effects on non-target organisms using a tiered assessment with clear thresholds to indicate the need to move between tiers. The latest EFSA guidance document on ERA of Genetically Modified Organisms considers specifically the receiving environment in preparation of ERA for commercial cultivation of GMPs. According to existing guidelines in the EU, the receiving environment is defined by three mutually interacting components: the characteristics of the environmental stressor (i.e. the GM plant), the bio-geographical regions where the commercial release of the crop is expected and the agricultural systems therein. Difference in agronomic and ecological conditions (e.g. use of different varieties, vegetation of adjacent areas, non-target species assemblages, sensitivity of local species to the stressors) suggests that explicit considerations of the receiving environments are necessary. Results from field experiments indicate that differences in cultivation practices, e.g. the herbicide regime used on herbicide-tolerant GM crops, may induce direct and indirect effects on wild plant distribution and abundance, with consequent repercussions on food webs based on these plants. Moreover, ecological literature indicates that the concept of surrogate species has clear limitations if applied broadly to any ERA. Starting from case studies regarding GMPs, this paper discusses some ecological and agronomic characteristics of agro-ecosystems, which have implications in the elaboration of both hazard and exposure analyses during ERA. The species selection approach indicated in the EFSA Guidance Document and the consideration of the area(s) of the expected release of the new variety may provide the basis to an ecologically sound ERA for a range of environmental stressors. The quality of the data that become available for risk managers with this approach may support a more transparent and dependable ERA and risk management for GMPs as well as for other potential environmental stressors in agro-ecosystems.

The accessibility of data on environmental risk assessment of pharmaceuticals - are environmental risk assessments information on emissions with respect to international and European environmental information law?

In the pharmaceutical sector, the right of access to environmental information is in most cases not feasible as the authorisation holders refer to commercially/industrial confidential information (CCI). However, CCI can not refuse access to environmental risk assessments (ERAs) if ERAs are to be classified as information on emissions. Pharmaceuticals inevitably enter the environment as a consequence of their intended use. This release is calculated in the ERA as predicted environmental concentration when a pharmaceutical is approved. The release of pharmaceuticals into the environment falls consequently under the term 'emissions into the environment'. In addition, the ERAs assessing the risk of this release are to be classified as 'information on emissions into the environment'. Therefore, the practiced secrecy of ERAs of pharmaceuticals and their official assessment reports is incompatible with Art. 4 Aarhus Convention, and the European and national implementing provisions for this article, which require access to such environmental information on emissions for everyone, irrespective of whether they concern CCI. With this legal disclosure obligation of ERAs, there is an enforceable right of access for everyone, which shows the necessity for establishing a publicly accessible database based on active pharmaceutical ingredients with substantiated information on the ERAs.

Mitigation pathways towards national ambient air quality standards in India.

Exposure to ambient particulate matter is a leading risk factor for environmental public health in India. While Indian authorities implemented several measures to reduce emissions from the power, industry and transportation sectors over the last years, such strategies appear to be insufficient to reduce the ambient fine particulate matter (PM2.5) concentration below the Indian National Ambient Air Quality Standard (NAAQS) of 40 µg/m3 across the country. This study explores pathways towards achieving the NAAQS in India in the context of the dynamics of social and economic development. In addition, to inform action at the subnational levels in India, we estimate the exposure to ambient air pollution in the current legislations and alternative policy scenarios based on simulations with the GAINS integrated assessment model. The analysis reveals that in many of the Indian States emission sources that are outside of their immediate jurisdictions make the dominating contributions to (population-weighted) ambient pollution levels of PM2.5. Consequently, most of the States cannot achieve significant improvements in their air quality and population exposure on their own without emission reductions in the surrounding regions, and any cost-effective strategy requires regionally coordinated approaches. Advanced technical emission control measures could provide NAAQS-compliant air quality for 60% of the Indian population. However, if combined with national sustainable development strategies, an additional 25% population will be provided with clean air, which appears to be a significant co-benefit on air quality (totaling 85%).

[Presence of microplastics in water and the potential impact on public health]. / Presencia de microplásticos en aguas y su potencial impacto en la salud pública.

The use of plastics has increased exponentially over recent years. Difficulties in their recycling and their low degradability result in their accumulation in the environment. Despite their great stability, they are subject to physical and chemical erosion resulting in smaller fragments. Although there is no standard definition of microplastics, the maximum limit of 5 mm has been accepted as a criterion. Plastics, in addition to the consequences on the environment, have a direct effect on living beings, either by ingestion or toxicity. They may also act as a vehicle for invasive species and adsorb other contaminants on their surface such as PCBs, PAHs or DDT. This, increases the toxic effect of their own components such as plasticizers, additives, heavy metals, etc. There is disparity in the published results regarding the presence of microplastics in both water supplies and drinking water and bottled water. There are no standard analytical methods, nor a consensus in the definition and description of microplastics that allow an appropriate comparison of results. In the absence of scientific evidence, it is necessary to study in depth the presence of microplastics in water and the potential effects on health, in order to be able to consider microplastics as a monitoring parameter in drinking water.

El uso de plásticos se ha visto incrementado de manera exponencial en los últimos años. Su difícil reciclaje y su baja capacidad de degradación tienen como consecuencia una acumulación de estos en el medio ambiente. Pese a su gran estabilidad, se ven sometidos a erosión física y química, dando lugar a fragmentos más pequeños. Aunque no hay una definición estandarizada del concepto de microplástico, se ha aceptado el límite máximo de 5 mm como criterio. Los plásticos, además de las consecuencias sobre el medio ambiente, tienen un efecto directo sobre los seres vivos, ya sea por ingestión o por toxicidad. También, pueden actuar como vehículos de especies invasoras y adsorber en su superficie otros contaminantes como los BPCs, los HAPs o el DDT, incrementando así el efecto tóxico propio debido a los componentes que poseen tales como plastificantes, aditivos, metales pesados, etc. Existe disparidad en los resultados publicados en cuanto a la presencia de microplásticos tanto en abastecimientos como en agua de consumo y embotellada. No existe una metodología normalizada de métodos analíticos, como tampoco rigor en la definición y descripción de los microplásticos que permitan la comparación de resultados. Ante la falta de evidencia científica, es necesario profundizar en el estudio sobre la presencia de estos y sus efectos potenciales en la salud, para ser considerado como un parámetro a vigilar en las aguas de consumo humano.

Shades of grey: Marine litter research developments in Europe.

European research efforts to address concerns in relation to increasing levels of marine litter and potential effects on ecosystems and human health have been launched. We assessed a total of 52 European projects which researched or contributed to the implementation of European marine litter legislation. These projects ranged from national initiatives, to large scale programmes involving multiple EU member states. The best represented topics within those European projects were 'Policy, Governance and Management' and 'Monitoring'. Comparatively 'Risk Assessment', 'Fragmentation' and 'Assessment Tools' were underrepresented. The analyses showed that West-European countries have contributed more to marine litter research and therefore received more funding. As a result, thematic hotspots were present, and scientific capacity is concentrated by topic and countries. The results indicate the need to continue to support initiatives to cover clearly identified gaps, either geographic or thematic, to deliver risk assessments and recommendations to address the marine litter issue.

Characteristics, hazards, and control of illegal villa (houses): evidence from the Northern Piedmont of Qinling Mountains, Shaanxi Province, China.

Unapproved and illegal buildings have sprawled into the Northern Piedmont of the Qinling Mountains. The problem of illegal villas has aroused widespread public opinion and concern. The ecological environment of the Qinling Mountains has been seriously affected by the resurgence of illegal villas. This paper introduces the characteristics and distribution of illegal villas, analyzes the hazards caused by illegal villas, and describes control measures for illegal villas and land consolidation and ecological remediation in the Northern Piedmont of the Qinling Mountains. The results show that illegal planning and illegal development, as well as local governments' irregularities, including control, governance, punishment, demolition, and compensation for illegal buildings in the expropriation of premises, have caused the problem of illegal construction of villas in the Northern Piedmont of the Qinling Mountains. Control measures for illegal villas are demolition, land consolidation, and ecological remediation. Policy implications for protection of Qinling Mountains are provided.

Assessment of pops contaminated sites and the need for stringent soil standards for food safety for the protection of human health.

Persistent organic pollutants (POPs) including PCDD/Fs, PCBs and organochlorine pesticides (OCPs) are among the most important and hazardous pollutants of soil. Food producing animals such as chicken, beef, sheep and goats can take up soil while grazing or living outdoors (free-range) and this can result in contamination. In recent decades, large quantities of brominated flame retardants such as polybrominated diphenyl ethers (PBDEs), short-chain chlorinated paraffins (SCCPs) and per- and polyfluorinated alkylated substances (PFAS) have been produced and released into the environment and this has resulted in widespread contamination of soils and other environmental matrices. These POPs also bioaccumulate and can contaminate food of animal origin resulting in indirect exposure of humans. Recent assessments of chicken and beef have shown that surprisingly low concentrations of PCBs and PCDD/Fs in soil can result in exceedances of regulatory limits in food. Soil contamination limits have been established in a number of countries for PCDD/Fs but it has been shown that the contamination levels which result in regulatory limits in food (the maximum levels in the European Union) being exceeded, are below all the existing soil regulatory limits. 'Safe' soil levels are exceeded in many areas around emission sources of PCDD/Fs and PCBs. On the other hand, PCDD/F and dioxin-like PCB levels in soil in rural areas, without a contamination source, are normally safe for food producing animals housed outdoors resulting in healthy food (e.g. meat, eggs, milk). For the majority of POPs (e.g. PBDEs, PFOS, PFOA, SCCP) no regulatory limits in soils exist. There is, therefore, an urgent need to develop appropriate and protective soil standards minimising human exposure from food producing animals housed outdoors. Furthermore, there is an urgent need to eliminate POPs pollution sources for soils and to control, secure and remediate contaminated sites and reservoirs, in order to reduce exposure and guarantee food safety.

Advancing environmental exposure assessment science to benefit society.

Awareness of the human health impacts of exposure to air pollution is growing rapidly. For example, it has become evident that the adverse health effects of air pollution are more pronounced in disadvantaged populations. Policymakers in many jurisdictions have responded to this evidence by enacting initiatives that lead to lower concentrations of air pollutants, such as urban traffic restrictions. In this review, we focus on the interplay between advances in environmental exposure assessment and developments in policy. We highlight recent progress in the granular measurement of air pollutants and individual-level exposures, and how this has enabled focused local policy actions. Finally, we detail an illustrative study designed to link individual-level health-relevant exposures with economic, behavioral, biological, familial, and environmental variables.

Why Do Countries Regulate Environmental Health Risks Differently? A Theoretical Perspective.

Why do countries regulate, or prefer to regulate, environmental health risks such as radiofrequency electromagnetic fields and endocrine disruptors differently? A wide variety of theories, models, and frameworks can be used to help answer this question, though the resulting answer will strongly depend on the theoretical perspective that is applied. In this theoretical review, we will explore eight conceptual frameworks, from different areas of science, which will offer eight different potential explanations as to why international differences occur in environmental health risk management. We are particularly interested in frameworks that could shed light on the role of scientific expertise within risk management processes. The frameworks included in this review are the Risk Assessment Paradigm, research into the roles of experts as policy advisors, the Psychometric Paradigm, the Cultural Theory of Risk, participatory approaches to risk assessment and risk management, the Advocacy Coalition Framework, the Social Amplification of Risk Framework, and Hofstede's Model of National Cultures. We drew from our knowledge and experiences regarding a diverse set of academic disciplines to pragmatically assemble a multidisciplinary set of frameworks. From the ideas and concepts offered by the eight frameworks, we derive pertinent questions to be used in further empirical work and we present an overarching framework to depict the various links that could be drawn between the frameworks.

Selected aspects of integrated environmental management.

Current trends in environmental care are characterised by the principles of comprehensiveness, integration, interdisciplinarity and transregionality. It is in this spirit that the methodological, legislative and economic instruments develop, and this whole trend is referred to using the term 'environmental management'. Environmental management constitutes a set of technical instruments and methods for managing the environment, based upon an identification of the environmental aspects of products, activities and services of any type of organisation, with the aim to adopt and implement effective proactive measures to reduce their negative impact on the environment. These measures, along with their level, relate to an organisation's possibilities, the market's pressure on it, and primarily with the organisation's management's awareness, maturity and ability to anticipate the introduction of stricter requirements. Environmental management, in the industrial production and service sectors, is one of the the most effective instruments for achieving the priority goal, which is to minimise the negative impact of production activities on the individual elements of the environment as part of the global trend of reducing the negative impact of human activity on the environment. The objective of this article is to indicate possibilities to improve the environment through the basic principles and techniques of integrated environmental management.

Economic valuation of noise pollution control policy: does the type of noise matter?

As the average noise level and number of noise sources have increased, governments have taken various measures to make soundscapes sustainable. Wise policy decisions require information about the monetary value of noise-control policies. This study elicited people's willingness to pay (WTP) for noise policies, separating traffic noise from residential noise to compare the value of controlling different types of noise. The contingent valuation method was used for the empirical analysis, with data from South Korea. The results show that the monthly mean WTP of respondents was KRW 3392.3 for residential noise reduction and KRW 3507.1 for transport noise reduction; thus, the WTP for the latter is slightly higher than that for the former. Moreover, about 80% of people are unwilling to pay for a noise policy at all, and that high ratio of people with zero WTP must be taken into consideration in the process of policy formulation and implementation. Respondents' experiential and psychological factors were found to be more important than their demographics in explaining their WTP for a noise policy. Potential policy implications based on the analysis results are provided.

Perspectives on Driving Changes in Project-based Cumulative Effects Assessment for Biodiversity: Lessons from the Canadian Experience.

Cumulative effects assessment (CEA), as a required practice for the environmental assessment (EA) of projects in many countries, faces several practical challenges, especially related to biodiversity. Drawing on the perspectives and experiences of Canadian EA practitioners, this paper explores options or drivers of change for improving project-based assessment to better tackle cumulative effects on biodiversity. An on-line survey was conducted with 40 professionals from the private sector, government departments/agencies, universities, and non-governmental organizations, examining the current challenges and opportunities regarding: CEA process for biodiversity; responsibilities for undertaking CEA tasks; resources to support and promote good CEA practice. In terms of process, there is shared understanding on: (i) the need of EA terms of reference to provide specific directions on CEA; (ii) CEA should capture both human and natural drivers of cumulative change; (iii) spatial boundaries for CEA should be based on ecological boundaries. There are dissenting views about: (i) whether CEA should consider all valued components (VCs) potentially affected by a project or only those for which residual effects are predicted; and (ii) delimitation of future temporal limits. In terms of responsibilities, participants agreed that project proponents should retain a central role in conducting CEA, but government agencies should lead the collection/provision of information about other projects in the study area and baseline VC conditions. Information and knowledge management resources could be also applied in the context of governmental agencies and consultancy firms to support CEA for biodiversity.

Carbon trading, co-pollutants, and environmental equity: Evidence from California's cap-and-trade program (2011-2015).

BACKGROUND: Policies to mitigate climate change by reducing greenhouse gas (GHG) emissions can yield public health benefits by also reducing emissions of hazardous co-pollutants, such as air toxics and particulate matter. Socioeconomically disadvantaged communities are typically disproportionately exposed to air pollutants, and therefore climate policy could also potentially reduce these environmental inequities. We sought to explore potential social disparities in GHG and co-pollutant emissions under an existing carbon trading program-the dominant approach to GHG regulation in the US and globally. METHODS AND FINDINGS: We examined the relationship between multiple measures of neighborhood disadvantage and the location of GHG and co-pollutant emissions from facilities regulated under California's cap-and-trade program-the world's fourth largest operational carbon trading program. We examined temporal patterns in annual average emissions of GHGs, particulate matter (PM2.5), nitrogen oxides, sulfur oxides, volatile organic compounds, and air toxics before (January 1, 2011-December 31, 2012) and after (January 1, 2013-December 31, 2015) the initiation of carbon trading. We found that facilities regulated under California's cap-and-trade program are disproportionately located in economically disadvantaged neighborhoods with higher proportions of residents of color, and that the quantities of co-pollutant emissions from these facilities were correlated with GHG emissions through time. Moreover, the majority (52%) of regulated facilities reported higher annual average local (in-state) GHG emissions since the initiation of trading. Neighborhoods that experienced increases in annual average GHG and co-pollutant emissions from regulated facilities nearby after trading began had higher proportions of people of color and poor, less educated, and linguistically isolated residents, compared to neighborhoods that experienced decreases in GHGs. These study results reflect preliminary emissions and social equity patterns of the first 3 years of California's cap-and-trade program for which data are available. Due to data limitations, this analysis did not assess the emissions and equity implications of GHG reductions from transportation-related emission sources. Future emission patterns may shift, due to changes in industrial production decisions and policy initiatives that further incentivize local GHG and co-pollutant reductions in disadvantaged communities. CONCLUSIONS: To our knowledge, this is the first study to examine social disparities in GHG and co-pollutant emissions under an existing carbon trading program. Our results indicate that, thus far, California's cap-and-trade program has not yielded improvements in environmental equity with respect to health-damaging co-pollutant emissions. This could change, however, as the cap on GHG emissions is gradually lowered in the future. The incorporation of additional policy and regulatory elements that incentivize more local emission reductions in disadvantaged communities could enhance the local air quality and environmental equity benefits of California's climate change mitigation efforts.

Parameters for assessing the aquatic environmental impact of cosmetic products.

The cosmetic industry's growing concern about the impact of its supply chain on the environment, sustainability of raw materials, and biodiversity increases the need to ensure that the final product has a lower environmental impact. The objective of this review is to summarize and compare the information available from international organizations and legislation regarding the main criteria used to assess raw materials for aquatic toxicity, as well as the most suitable alternative methods for obtaining assessment parameters. Using the literature available in databases, a review of the scientific literature and international legislation, this work discusses and compares the parameters established by international organizations such as the Environmental Protection Agency (EPA) and Cradle to Cradle (C2C), as well as European legislation, namely, European Regulation 1272/2008, for assessing environmental impact. Defining the ecotoxicity parameters of the main classes of raw materials in rinse-off cosmetic products can enable the development of products that are more environmentally sustainable, prioritizing substances with less environmental impact.

A user's guide to coping with estuarine management bureaucracy: An Estuarine Planning Support System (EPSS) tool.

Estuaries are amongst the most socio-economically and ecologically important environments however, due to competing and conflicting demands, management is often challenging with a complex legislative framework managed by multiple agencies. To facilitate the understanding of this legislative framework, we have developed a GISbased Estuarine Planning Support System tool. The tool integrates the requirements of the relevant legislation and provides a basis for assessing the current environmental state of an estuary as well as informing and assessing new plans to ensure a healthy estuarine state. The tool ensures that the information is easily accessible for regulators, managers, developers and the public. The tool is intended to be adaptable, but is assessed using the Humber Estuary, United Kingdom as a case study area. The successful application of the tool for complex socio-economic and environmental systems demonstrates that the tool can efficiently guide users through the complex requirements needed to support sustainable development.

Can the Stockholm convention address the spectrum of chemicals currently under regulatory scrutiny? Advocating a more prominent role for modeling in POP screening assessment.

Frameworks for chemical regulation are based on the science at the time they were written. Today some regulations are being applied to a much broader spectrum of chemicals than we had knowledge of when the regulations were written. This entails a risk that the regulations are being used outside of their chemical application domain. This question is explored using the POP screening assessment in the Stockholm convention, which was developed 20 years ago. Using perfluorinated alkyl acids (PFAAs) as an example, it is shown that the assessment can lead to false negative conclusions. A second case study using octamethylcyclotetrasiloxane (D4) illustrates that there is also a risk of false positives. The risk for false negative classification of PFAAs is due to the inclusion of a screening criterion - bioaccumulation - that is not a requirement for adverse effects of chemicals in remote regions. For D4 the risk of false positive classification stems from the four screening criteria (persistence, bioaccumulation, long-range transport, and adverse effects) applying to different environmental media/compartments. The major lesson is that applying the POP screening procedure to the broad spectrum of chemicals in modern commerce will require that we rely less on the individual screening criteria and more on the comparison of estimated exposure and the thresholds for effects stipulated in Annex D, paragraph 2 of the convention. Models have an important role to play in this context and should become more strongly integrated into the POP screening process.

Analysis of the Governance Structures in Japan's Biosphere Reserves: Perspectives from Bottom-Up and Multilevel Characteristics.

This paper analyzes the governance structures of Biosphere Reserves (BRs) in Japan by focusing on six criteria that elucidate the main characteristics therein: general information (nomination process, year of designation, size, and population), legal frameworks, stakeholder identification, and decision-making processes (number of municipalities and role of consociation), administrative institutions (human resources, budgetary situation, and expense distribution), executed BR implementation activities, and participatory/collaborative frameworks. This research consists of a literature review, a questionnaire administered to the secretariats of seven existing BRs and follow-up interviews. Three main characteristics of BRs were identified. First, a responsible local government(s) is nominated to manage the BR rather than the central government. Consequently, BR implementation in Japan is led by those municipalities that have strong motivations for regional development using the BR concept. Second, two types of BR governance structures exist in Japan: the single municipality type and the multi-municipality type. All BRs have so called Kyougikai, a consociation for decision-making, consultation and/or collaboration among stakeholders. In the single municipality structure, the consociation includes diverse actors from private and community sectors, while in the multi-municipality structure, consociations are based in more diplomatic settings and only include members of the public sector. Third, gaps between pre/post-Seville BR implementation sites were identified. The motivations for the formation of pre-Seville BRs, which were designated in 1980 in a top-down fashion prior to an awareness of BRs, varied greatly from those BRs nominated by municipalities after 2010. The authors identified fewer administrative resources and activities associated with the pre-Seville sites.

[Hygiene and legal aspects of occupational exposure assessment to cytostatics]. / Aspekty higieniczne i prawne oceny narazenia zawodowego na cytostatyki.

The employers responsibilities for the assessment of occupational exposure to cytostatics in the workplace were analyzed in the light of existing legal regulations. Cytostatics may pose a threat to health and life of workers taking care of patients treated oncologically, i.e., pharmacists, physicians, nurses and other personnel. The significant scale of occupational exposure to cytostatics in Poland is confirmed by the data collected in the Central Register of Data on Exposure to Carcinogenic or Mutagenic Substances, Mixtures, Agents or Technological Processes, maintained by the Nofer Institute of Occupational Medicine, Lódz, Poland. The issue of occupational risk assessment of exposure to cytostatics gives raise to numerous concerns. Polish regulations concerning health protection of employees occupationally exposed to cytostatics are not unequivocal, as they are derived from different areas of the law, especially those applying to hazard classification, labeling and preparation of safety data sheets for cytostatics. There are neither binding occupational exposure limits legally set for active compounds of antineoplastic drugs nor methods for monitoring of these substances concentrations in a worker's breathing zone and biological material. This prevents the employer to carry out the correct assessment of occupational exposure, the results of which are the basis for preparing the proper preventive strategy. In this article the consequences of amendments to the European chemical legislation for employers responsible for adequate protection of health and life of employees exposed to cytostatics, were discussed, as well as some legal changes aimed at a better health and life protection of workers exposed to cytostatics in a workplace were proposed. Med Pr 2018;69(1):77-92.