Guidelines For Environmental Risk Assessment Research Articles

Progress in the environmental risk assessment of plant protection products in Brazil: An overview of birds and mammals and soil organisms proposals.

Since 2019, the Brazilian Institute of Environment and Renewable Natural Resources (IBAMA) has actively developed pesticide environmental risk assessment (ERA) frameworks adapted to Brazil's specific ecological contexts. This initiative, supported by funding from the Brazilian Ministry of Justice and in partnership with academic institutions, has led to a concerted effort to establish ERA protocols for various taxa, including birds and mammals, soil organisms, aquatic organisms, and reptiles and amphibians. The outcomes of this initiative were disseminated in two distinct workshops held in February and November of 2023, where the agency showcased its research to the technical-regulatory community. This article synthesizes the proposals for birds and mammals and soil organisms. First, we summarize the agency's proposals for both focal and generic species to be incorporated into the ERA and the methodologies for calculating exposure of these taxa to pesticides through agricultural practices, encompassing seed treatment and foliar applications. On this occasion, IBAMA also disclosed the risk assessment tool that the agency is developing for birds and mammals. IBAMA highlighted the knowledge gaps that must be bridged to progress from preliminary (lower-tier) to more comprehensive (higher-tier) assessments. Regarding soil organisms, during the workshop, the presenters shared findings on the most prevalent species of earthworms and enchytraeids in Brazil. They emphasized the need for additional data collection on a regional scale. The agency has also proposed methods for estimating soil organism exposure to pesticides at a screening level and identified specific data gaps that could be addressed to refine assessments at higher tiers. In summary, the workshop communicated the progress in establishing ERA guidelines, which we encapsulate here to benefit the technical-regulatory community. Integr Environ Assess Manag 2024;20:1793-1799. © 2024 The Author(s). Integrated Environmental Assessment and Management published by Wiley Periodicals LLC on behalf of Society of Environmental Toxicology & Chemistry (SETAC).

Analysing the environmental impact of IMO sulphur regulation 2020, annex VI, MARPOL

The IMO has set different SOx limits over the years, including different limits for SECA and areas outside SECA. The EU has formulated stricter limits for its member states. The EU port and SECA areas have reduced SOx emissions vastly. Ocean acidification, degradation of the environment, and human health has been improved in the EU ports and SECA areas. However, the improvement at the global level is limited. SOx emission causes a cooling effect on temperature and decreases the warming effect of GHG emissions. The lowering of SOx can impact global warming. Further, the Black Carbon emission from alternate fuels can lead to increased GHG emissions. The acidic wash water from EGCS contains toxic metals and PAHs which when discharged at sea cause severe damage. The SOx reduction, Black Carbon emission and wash water discharge adversely impact oceans and violates the UNCLOS, UNFCCC, Paris Agreement, CBD, and even the UNDRIP. An IPCC report will help analyse the SOx, Black Carbon emission, and wash water impact, which can be taken up in COP 28. The 2022 MEPC Guidelines for Environmental Risk Assessment and reception of wash water, with Port authorities are based on the submissions by nations and environmental organizations to the PPR 9, which have highlighted the environmental problems and challenges in the use of EGCS and the discharge of its wash water. The guidelines are non-binding and may not have the desired impact. Much stricter regulation is required to ensure the protection of the marine environment.

A review of the study of environmental modeling tools to understand the real impact of cosmetic products on environmental safety

In contrast to human health risk assessment, there are no definitive guidelines for environmental risk assessment of cosmetic products. The objective of this study was to perform an in-depth analysis of ten modeling environmental tools and to establish the best rationale to assess the impact on environmental safety considering the recent global pandemic scenario and the evolution of the consumer mindset. A literature analysis was performed for the ten modeling environmental tools, and when possible, each was downloaded for comparison. Chesar was the tool that proved to be the easiest to enter data, and it has the more straightforward and direct application steps; thus, it was chosen for the initial assessment of ingredients that demonstrate potential environmental hazards. For high-level tools, it was not possible to establish a comparison for choice, as the models are private and have little data in the literature. Even so, for a more detailed assessment after the first initial assessment via Chesar, iSTREEM could be used. This study delivers important knowledge about the modeling tools and how to establish a rationale for environmental risk assessment. Keywords: environmental modeling tools, environmental risk assessment, cosmetic products, environmental impact, formulation

A COMPARATIVE STUDY OF ENVIRONMENT RISK ASSESSMENT GUIDELINES FOR GENETICALLY ENGINEERED PLANTS OF DEVELOPING AND DEVELOPED COUNTRIES INCLUDING BANGLADESH

Genetically Engineered (GE) plants are the demand of time for increased need of food. The regulation system, followed from the development of a GE plant to its release into the environment is categorized into separate stages for maintaining the proper biosafety including Environmental Risk Assessment (ERA). ERA identifies potential risks and its impacts through science based evaluation process where it follows a case by case study. All the countries dealing with GE plants follow specific guidelines to conduct a successful ERA. In this study, ERA guidelines of 4 developing and 4 developed countries including Bangladesh were compared in terms of required data and information against ten criteria. Surprisingly, an adequate amount of data and information requirements (e.g. if the intended modification has been achieved or not, growth habit of GE plants, potential adverse effects on the human health etc.) matched between all the countries. However, a few differences of data requirement such as agronomic conventions of non-transformed plants, clear description of experimental procedures followed etc. were also observed in the study. Moreover, the result indicates that only a few countries provide instructions on the quality of the data used for ERA. Thus, if the similarities are recognized in a more framed manner then the approval pathway of GE plants can be shared.

Environmental Risk Assessment for Exploration and Extraction Processes of Unconventional Hydrocarbon Deposits of Shale Gas and Tight Gas: Pomeranian and Carpathian Region Case Study as Largest Onshore Oilfields

Shale gas and tight gas exploration and extraction processes create potential threats to the environment. In Poland, no comprehensive guidelines for environmental risk assessment have been prepared so far. This paper presents a proposal of environmental risk assessment methodology which can be used for corporate risk management procedures during exploration and extraction of unconventional hydrocarbons in Poland. The most frequent environmental threats that may occur during the exploration and exploitation of unconventional hydrocarbon deposits include degradation of soils through construction of drilling rigs and access roads, landforms change, local soil pollution caused by fuels, cleaning agents and materials used to prepare drilling fluids, rubble, cement, gravel, pollution of surface and underground water as a result of emergency discharges of sewage, infiltration of pollution from waste reservoirs, disturbance of hydrogeological equilibrium through significant water intake, noise and atmospheric pollution resulting from the combustion of fuels. To check the level of these threats’ six exploration sites form Pomeranian and Carpathian region of Poland (3 wells of shale gas and 3 wells of tight gas) have been evaluated in detail, and the risk quantification has been made. Because of a local, short-term and reversible environment impact, the environmental risks for the exploration and extraction processes of unconventional hydrocarbons have been found to be medium or negligibly small. It is recommended that using the same methodology for other regions of Poland where we can find unconventional hydrocarbons and it can be enriched in dedicated application with spatial maps to give the investors a quick feedback on the potential environmental risks. Key words: environmental risk assessment, sustainable development, shale gas, tight gas drilling rig, environment pollution.

Divergence between general public's risk perception and environmental risk assessment: A case study of p-xylene projects in China

ABSTRACTThe growing public opposition to p-xylene (PX) project proposals in China requires understanding the divergence between the general public's risk perception and environmental risk assessment (ERA) results and its implications on its decision-making. In a case study in Fujian Province of China, a questionnaire was designed to investigate the public perception of risks of a proposed PX project, interviews were further conducted in Zhangzhou City and Xiamen City, and the survey results were compared with the ERA results of the proposed PX project. Results indicate that the environmental risk is acceptable according to current technical ERA guidelines and standards, while the public acceptance of the PX project is very low. The underlying factors causing the difference between the general public's risk perception and ERA results were identified from the ERA technical perspective. A better understanding of the risk perception divergence from different disciplinary perspectives is helpful for the public acceptance of these kinds of projects, which are on high demand in China. This study not only highlights the necessity to improve the risk communication but also provides insights on future research of ERA for this kind of large-scale project proposal.

EFSA Guidelines on the environmental risk assessment of genetically modified animals in the EU: the process and risk assessment considerations

The scientific Panel of the European Food Safety Authority (EFSA) on genetically modified organisms (GMOs) developed guidelines for the environmental risk assessment of genetically modified (GM) animals that provide specific recommendations for GM fish, GM insects, GM mammals and GM birds. The guidelines advocate that the environmental risk assessment of GM animals is conducted on a case-by-case basis, in a scientifically sound and transparent manner, and follows common methodology for the identification, gathering and interpretation of the data. Besides specific considerations, the guidelines provide generic advice on the choice of comparators, the use of non-GM surrogates, the assessment of long-term effects, uncertainty analysis, modelling requirements and statistical principles. Three dedicated Working Groups of the EFSA GMO Panel were involved in the elaboration of the environmental risk assessment guidelines, which underwent a public consultation before finalisation. Relevant comments received from risk assessment bodies of EU Member States, the scientific community, stakeholders and the public were considered by the Working Groups. The Working Groups also took into account the external scientific reports on GM fish, GM insects, GM mammals and GM birds commissioned by EFSA. These reports provided background information by mapping relevant fields of expertise and identifying essential elements to be considered when performing an environmental risk assessment of GM animals.

Ranking matrices as operational tools for the environmental risk assessment of genetically modified crops on non-target organisms

For the operationalization of the structured, stepwise selection procedure for non-target testing organisms integrated into the new EFSA guidelines for environmental risk assessment of GM plants practical tools – i.e. ranking matrices – were developed. These tools – some of them are new and some are refined from older ones – were tested using the GM case crop of TC 1507 maize. The selection procedure consists of six steps. The strategy builds on identifying the important ecological functions for the particular cropping system and compiling a species lists according to their ecological functions and presence in the specific receiving environments. Subsequently, the species numbers are reduced in a systematic, stepwise fashion to a relevant and practical number of testing organisms and/or processes.Four ecological functional categories were selected: herbivory, pollination, natural enemies and soil organisms/processes. Based on these categories, the relevant species were chosen and subjected to the selection steps. Out of a total of 33 herbivores, 73 pollinators/pollen feeders, 48 natural enemies and 77 soil organisms/processes we started with in Step 1, 15 herbivores, 10 pollinators 17 natural enemy species and 9 soil organisms/processes were selected as relevant and suited for a testing program at the end of the selection procedure in Step 4.Although the ranking tools will continue to need further refinement, we could demonstrate that this procedure allows to swiftly select the most important suite of species and processes from a large number of organisms. This expert-driven process increases ecological realism and transparency in risk assessment and tailors it to the particular receiving environment, thus, overcoming important deficiencies of the current approach that has attracted persistent criticism. We recommend balancing ecological requirements with practicability criteria and realism in the test strategy. At present, the ranking is abundance-oriented and, thus, excludes rare and/or endangered species that are sensitive to disturbances. We suggest additional selection criteria to strengthen nature conservation and off-field aspects.

Preventing Antibiotic Resistance in the Wild: A New End Point for Environmental Risk Assessment

Human and veterinary antibiotics enter the environment through wastewater effluent, agricultural use of manure and treated sewage for fertilizer, and leakage from waste storage facilities. This antibiotic pollution may exert selective pressure on bacteria to develop drug resistance, which is especially concerning if it develops in pathogenic bacteria. A new study weighs known bacterial antibiotic sensitivities against the backdrop of antibiotic concentrations measured in the environment and suggests that resistance in clinically relevant bacteria may not be kept in check by current risk assessment action levels [EHP 120(8):1100–1106; Tello et al.]. Ciprofloxacin, erythromycin, and tetracycline were selected for the analysis from among the approximately 150 compounds for which minimum inhibitory concentrations (MICs) have been reported for different bacteria. An MIC is the amount of antibiotic needed to inhibit bacterial growth. Each of the three antibiotics affects a wide range of bacteria and represents a distinct class of antibiotics used in humans and animals. Concentrations of each antibiotic in various environmental compartments, or media, had been documented previously. Current guidelines for environmental risk assessment reflect the phase I action limits of the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products. This program, which evaluates the safety of veterinary drugs, calls for environmental risk assessment of antibiotics whose concentrations exceed 1 ppb in aquatic compartments or 100 ppb in terrestrial compartments. These guidelines have been implemented in regulations in the United States, Europe, Japan, and Australia. www.jasonschneider.com The researchers compared information on antibiotic levels in the environment with information on the MICs of clinically relevant bacteria to determine if current levels of antibiotic pollution might be high enough to promote the development of resistance. Within aquatic compartments, only a small fraction of the 27 bacterial genera included in the study were predicted to be affected by environmental concentrations of antibiotics, and results suggested that the phase I action level would protect against resistance. However, current levels of antibiotic pollution in terrestrial compartments—particularly in river sediments, liquid manure, and farmed soil—may be high enough to favor the evolution of bacterial resistance. The conclusions may be limited by long-term selective pressure and by the fact that MIC tests do not represent environmental conditions. Furthermore, the authors did not address bioavailability or the potential influences of antibiotic mixtures, metals, or disinfectants. Nevertheless, the potential for antibiotic pollution to increase antibiotic resistance in clinically relevant bacteria has important implications for public health and environmental health policy, and the authors demonstrate a possible framework for answering important outstanding questions about the environmental impact of antibiotics.

Environmental risk assessment of ivermectin: A case study

The veterinary parasiticide ivermectin was selected as a case study compound within the project ERAPharm (Environmental Risk Assessment of Pharmaceuticals). Based on experimental data generated within ERAPharm and additional literature data, an environmental risk assessment (ERA) was performed mainly according to international and European guidelines. For the environmental compartments surface water, sediment, and dung, a risk was indicated at all levels of the tiered assessment approach. Only for soil was no risk indicated after the lower tier assessment. However, the use of effects data from additional 2-species and multispecies studies resulted in a risk indication for collembolans. Although previously performed ERAs for ivermectin revealed no concern for the aquatic compartment, and transient effects on dung-insect populations were not considered as relevant, the present ERA clearly demonstrates unacceptable risks for all investigated environmental compartments and hence suggests the necessity of reassessing ivermectin-containing products. Based on this case study, several gaps in the existing guidelines for ERA of pharmaceuticals were shown and improvements have been suggested. The action limit at the start of the ERA, for example, is not protective for substances such as ivermectin when used on intensively reared animals. Furthermore, initial predicted environmental concentrations (PECs) of ivermectin in soil were estimated to be lower than refined PECs, indicating that the currently used tiered approach for exposure assessment is not appropriate for substances with potential for accumulation in soil. In addition, guidance is lacking for the assessment of effects at higher tiers of the ERA, e.g., for field studies or a tiered effects assessment in the dung compartment.

Lessons Learned From the Investigation of a Cluster of Cutaneous Anthrax Cases in Connecticut

In 2007, two cases of cutaneous anthrax associated with West African drum making were reported in Connecticut in a drum-maker and his child. Although both cases were due to exposure to naturally occurring Bacillus anthracis from imported animal hides, ensuing investigative and remediation efforts were affected by the intentional B anthracis attacks in 2001. To share our experience of responding to an outbreak of anthrax in the biologic terrorism preparedness era, we summarize Connecticut's investigation and describe lessons learned. Laboratory capacity to rapidly assist in diagnosing anthrax, collaborative associations between epidemiologists and law enforcement personnel, and training in use of the Incident Command System, all these a result of public health preparedness, enhanced the initial recognition and subsequent investigation of these anthrax cases. However, without established guidelines for environmental risk assessment and remediation of private residences contaminated by B anthracis, challenges were encountered that resulted in a conservative and expensive approach to remediation. Without a more rigorous approach to ensuring that B anthracis spore-free hides are used, the making of animal hide drums is likely to pose a continuing risk for anthrax to those working with contaminated hides and those exposed to subsequently contaminated environments.

Human pharmaceuticals in surface waters: Implementation of a prioritization methodology and application to the French situation

Human pharmaceuticals are widely used and can reach surface waters, where they have the potential to exert biological effects on aquatic non-target organisms. Due to the high number of pharmaceutical drugs used in human medicine throughout the world, it is necessary to select the pharmaceuticals to search for, prior to implementing any environmental measurements and any extensive environmental risk assessment (ERA). This paper describes a methodology developed in order to define this selection. The prioritization scheme consists in three tiers. First, a preliminary classification based on the assessment of exposure is implemented. This exposure assessment is determined by calculating predicted environmental concentrations (PECs) for each pharmaceutical according to the European Medicine Evaluation Agency's (EMEA's) environmental risk assessment guidelines [EMEA, 2006. European Medicine Agency Guideline on the Environmental Risk Assessment of Medicinal Products for Human Use. EMEA/CHMP/SWP/4447/00.]. In the second step, the preliminary classification is reviewed on a case-by-case hypothesis basis using all the biological data available: ecotoxicological, pharmacological (mechanism of action (MoA), enzyme modulation, adverse effects) and physicochemical data (log K ow). Finally, an additional step is used to select priority compounds among molecules showing the same chemical structure and the same mechanism of action. We applied this methodology to the French situation and prioritized 120 parent molecules and 30 metabolites. The final prioritization list gathers 40 parent compounds and 14 metabolites. Among the 40 parent molecules, 21 have already been found in the aquatic environment, indicating a good agreement between the theoretical approach and the environmental measurements. Parameters used to construct the effect criteria are discussed for their relevance.