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1.
Heliyon ; 10(15): e34825, 2024 Aug 15.
Artigo em Inglês | MEDLINE | ID: mdl-39157411

RESUMO

In this case study pharmaceuticals were analysed in the Mondego river (Portugal) and their environmental risk assessed by means of risk quotients based on an extensive retrieval of ecotoxicological data for freshwater and saltwater species. The Mondego river crosses Coimbra, the most populated city in the Portuguese Centro Region hosting a complex of regional hospitals. Environmentally relevant and prioritised pharmaceuticals were investigated in this study and their potential hazards were evaluated by conducting a separate risk assessment for the freshwater and estuary parts of the examined river section. A target analysis approach with method detection limits down to 0.01 ng L-1 was used to determine pharmaceuticals. Twenty-one prioritised target analytes out of seven therapeutical classes (antibiotics, iodinated X-ray contrast media (ICM), analgesics, lipid reducers, antiepileptics, anticonvulsants, beta-blockers) were investigated by applying ultra-high pressure liquid chromatography coupled to a triple quadrupole mass spectrometer equipped with an electrospray ionisation source. The relative pattern of pharmaceuticals along the middle to the lower Mondego showed a quite uniform picture while an approximately 40fold increase of absolute concentrations was observed downstream of the wastewater treatment plant (WWTP) discharge of Coimbra. The most frequently measured substance groups were the ICM, represented by the non-ionic ICM iopromide (ßmin: 3.03 ng L-1 - ßmax: 2,810 ng L-1). Environmentally more critical substances such as carbamazepine, diclofenac, and bezafibrate, with concentrations up to and 52.6 ng L-1, 59.8 ng L-1, and 10.2 ng L-1 respectively, may potentially affect aquatic wildlife. Carbamazepine revealed elevated risk quotients (RQs >1) along the middle and lower Mondego with a maximum RQ of 53 downstream of Coimbra. Especially for saltwater species, carbamazepine and clarithromycin pose high potential risks. Especially in periods of low water discharge of the Mondego river, other pharmaceuticals as diclofenac and bezafibrate may pose additional risks downstream of the WWTP.

2.
Sci Total Environ ; 950: 175311, 2024 Aug 08.
Artigo em Inglês | MEDLINE | ID: mdl-39122031

RESUMO

RNA interference (RNAi) technology has emerged as a pivotal strategy in sustainable pest management, offering a targeted approach that significantly mitigates the environmental and health risks associated with traditional insecticides. Originally implemented through genetically modified organisms (GMOs) to produce specific RNAi constructs, the technology has evolved in response to public and regulatory concerns over GMOs. This evolution has spurred the development of non-transgenic RNAi applications such as spray-induced gene silencing (SIGS), which employs double-stranded RNA (dsRNA) to silence pest genes directly without altering the plant's genetic makeup. Despite its advantages in specificity and reduced ecological footprint, SIGS faces significant obstacles, particularly the instability of dsRNA in field conditions, which limits its practical efficacy. To overcome these limitations, innovative delivery mechanisms have been developed. These include nanotechnology-based systems, minicells, and nanovesicles, which are designed to protect dsRNA from degradation and enhance its delivery to target organisms. While these advancements have improved the stability and application efficiency of dsRNA, comprehensive assessments of their environmental safety and the potential for increased exposure risks to non-target organisms remain incomplete. This comprehensive review aims to elucidate the environmental fate of dsRNA and evaluate the potential risks associated with its widespread application on non-target organisms, encompassing soil microorganisms, beneficial insects, host plants, and mammals. The objective is to establish a more refined framework for RNAi risk assessment within environmental and ecotoxicological contexts, thereby fostering the development of safer, non-transgenic RNAi-based pest control strategies.

3.
Environ Toxicol Chem ; 2024 Jul 29.
Artigo em Inglês | MEDLINE | ID: mdl-39073366

RESUMO

We investigated the occurrence and the environmental risk of eight contaminants of emerging concern (CECs; acetaminophen, naproxen, diclofenac, methylparaben, 17ß-estradiol, sulfathiazole, sulfadimethoxine, and sulfamethazine) in three Brazilian water bodies, namely, the Monjolinho River Basin (São Paulo State), the Mogi Guaçu River (São Paulo State), and the Itapecuru River (Maranhão State) in three sampling campaigns. The CECs were only quantified in surface water samples collected at the Monjolinho River Basin. Acetaminophen, naproxen, and methylparaben were detected in the range of <200 to 575.9 ng L-1, <200 to 224.7 ng L-1, and <200 to 303.6 ng L-1, respectively. The detection frequencies of the three measured compounds were between 33% and 67%. The highest concentrations of CECs were associated with intense urbanization and untreated sewage discharge. Furthermore, CEC concentrations were significantly correlated with total organic carbon, electrical conductivity, and dissolved oxygen levels, suggesting that domestic pollution from urban areas is an important source in the distribution of CECs in the Monjolinho River Basin. The environmental risk assessment indicated a high risk for acetaminophen (risk quotient [RQ] values between 2.1 and 5.8), a medium risk for naproxen (RQs between 0.6 and 0.7), and a low risk for methylparaben (RQs < 0.1) to the freshwater biota of the Monjolinho River Basin. Our findings show potential threats of CECs in Brazilian water bodies, especially in vulnerable areas, and reinforce the need for improvements in environmental regulations to include monitoring and control of these compounds in aquatic systems. Environ Toxicol Chem 2024;00:1-12. © 2024 SETAC.

4.
Environ Int ; 190: 108865, 2024 Jul 02.
Artigo em Inglês | MEDLINE | ID: mdl-38972112

RESUMO

This study conducted the development of an advanced risk assessment algorithm system and safety management strategies using pesticide residue monitoring data from soils. To understand the status of pesticide residues in agricultural soils, monitoring was performed on 116 types of pesticides currently in use across 300 soil sites. The analysis of the monitoring results, alongside the physicochemical properties of the pesticides, led to the selection of soil half-life as a critical component in residue analysis. The use of Toxicity Exposure Ratio (TER) and Risk Quotient (RQ) for environmental risk assessment, based on monitoring data, presents limitations due to its single-component, conservative approach, which does not align with actual field conditions. Therefore, there is a necessity for a risk assessment process applicable in real-world scenarios. In this research, an efficient and accurate risk assessment algorithm system, along with a safety management model, was developed. Using the physicochemical properties of pesticides (such as soil half-life), monitoring results, and toxicity data, cluster analysis and Principal Component Analysis (PCA) validation identified four pesticides: boscalid, difenoconazole, fluquinconazole, and tebuconazole. The k-mean cluster analysis selected three priority management sites where the contribution of these four pesticides to the RQ was between 94-99 %, showing similar results to the RQ calculated for all pesticides. Predictions made with the developed model for the time required for soil half-life based RQ to drop below 1 at these priority sites showed only a 1-9 day difference between the four pesticides of concern and all pesticides, indicating comparable outcomes. The scenario of replacing high-risk pesticides with those of lower risk demonstrated that the RQ could be consistently maintained at about 50 % level. The results of this study suggest that through monitoring, evaluation, and management, effective and accurate environmental safety management of pesticides in soil can be achieved.

5.
Environ Sci Pollut Res Int ; 31(35): 47742-47756, 2024 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-39007972

RESUMO

For contaminated sites, conceptual site models (CSMs) guide the assessment and management of risks, including remediation strategies. Recent research has expanded diagrammatic CSMs with structural causal modeling to develop what are nominally called conceptual Bayesian networks (CBNs) for environmental risk assessment. These CBNs may also be useful for problems of controlling and preventing offsite contaminant migration, especially for sites containing dense nonaqueous phase liquids (DNAPLs). In particular, the CBNs provide greater clarity on the causal relationships between source term, onsite and offsite migration, and remediation effectiveness characterization for contaminated DNAPL sites compared to traditional CSMs. These ideas are demonstrated by the inclusion of modifying variables, causal pathway analysis, and interventions in CBNs. Additionally, several new extensions of the CBN concept are explored including the representation of measurement variables as lines of evidence and alignment with conventional pictorial CSMs for groundwater modeling. Taken as a whole, the CBNs provide a powerful and adaptable knowledge representation tool for remediating subsurface systems contaminated by DNAPL.


Assuntos
Teorema de Bayes , Água Subterrânea , Água Subterrânea/química , Poluentes Químicos da Água , Medição de Risco , Incerteza , Recuperação e Remediação Ambiental/métodos
6.
Environ Geochem Health ; 46(9): 314, 2024 Jul 13.
Artigo em Inglês | MEDLINE | ID: mdl-39002000

RESUMO

The levels of three phenolic endocrine-disrupting compounds (EDCs), NP, BPA and 4-t-OP were determined in water and sediment collected from sites along the Xiangjiang River, Zunyi, China. The NP, BPA and 4-t-OP concentrations ranged from 18.02 to 311.79 ng/L in the surface water, 16.04-408.12 ng/L in the submerged water, and 21.13-892.37 µg/kg dw in the sediment. NP contamination was most severe in both the river water and sediment. The ranges of the three phenolic EDCs were slightly greater in the submerged water than in the surface water (p > 0.05). The concentrations in the middle reaches were greater than those in the upstream and downstream reaches in both the water and sediment, and significant differences in content were detected in some reaches. The levels of three phenolic EDCs in the water and sediment had a positive correlation. In addition, the distribution coefficient (Kd) indicated that NP was more likely to adsorb to the sediment, and BPA and 4-t-OP were more likely to adsorb to river water. Moreover, the risk quotient (RQ) and hazard quotients (HQ) were used to reveal the environmental and health risks caused by coexposure to the three phenolic pollutants. The results showed that the current pollution is a threat to the environment of the study area and not a threat to the health of the local population.


Assuntos
Compostos Benzidrílicos , Disruptores Endócrinos , Monitoramento Ambiental , Sedimentos Geológicos , Fenóis , Rios , Poluentes Químicos da Água , Disruptores Endócrinos/análise , Rios/química , Poluentes Químicos da Água/análise , China , Fenóis/análise , Medição de Risco , Sedimentos Geológicos/química , Compostos Benzidrílicos/análise
7.
Sci Total Environ ; 948: 174645, 2024 Oct 20.
Artigo em Inglês | MEDLINE | ID: mdl-38986702

RESUMO

Hydroelectric power facilities can generate episodic total dissolved gas supersaturation (TDGS), which is harmful to aquatic life. We developed a decision tree-based risk assessment to identify the potential for TDGS at hydropower plants and conducted validation measurements at selected facilities. Applying the risk model to Norway's hydropower plants (n = 1696) identified 473 (28 %) high-risk plants characterized by secondary intakes and Francis or Kaplan turbines, which are prone to generating TDGS when air is entrained. More than half of them discharge directly to rivers (283, 17 % of total). Measurements at 11 high-risk plants showed that 8 of them exhibited biologically relevant TDGS (120 % to 229 %). In Austria and Germany, the analysis of hydropower plants was limited due to significant data constraints. Out of 153 hydropower plants in Austria, 80 % were categorized at moderate risk for TDGS. Two Austrian plants were monitored, revealing instances of TDGS in both (up to 125 %). In Germany, out of 403 hydropower plants, 265 (66 %) fell into the moderate risk, with none in the high-risk category. At a dam in the Rhine River, TDGS up to 118 % were observed. Given the uncertainty due to limited data access and the prevalence of run-of-river plants in Austria and Germany, there remains an unclarified risk of TDGS generation in these countries, especially at spillways of dams and below aerated turbines. The results indicate a previously overlooked potential for the generation of biologically harmful TDGS at hydropower installations. It is recommended to systematically screen for TDGS at hydropower installations through risk assessment, monitoring, and, where needed, the implementation of mitigation measures. This is increasingly critical considering the expanding global initiatives in hydropower and efforts to maintain the ecological status of freshwater ecosystems.


Assuntos
Monitoramento Ambiental , Centrais Elétricas , Áustria , Alemanha , Noruega , Monitoramento Ambiental/métodos , Medição de Risco , Rios/química , Poluentes Químicos da Água/análise , Gases/análise
8.
J Hazard Mater ; 476: 134998, 2024 Sep 05.
Artigo em Inglês | MEDLINE | ID: mdl-38991641

RESUMO

Currently, there is uncertainty about emissions of pharmaceuticals into larger closed ecosystems that are at risk such as the Baltic Sea. There is an increasing need for selecting the right strategies on advanced wastewater treatment. This study analysed 35 pharmaceuticals and iodinated X-ray contrast media in effluents from 82 Wastewater Treatment Plants (WWTPs) across Denmark, Estonia, Finland, Germany, Latvia, Lithuania, Poland and Sweden. Measured concentrations from Finland and Denmark were compared to predicted effluent concentrations using different levels of refinement. The concentrations predicted by the Total Residue Approach, as proposed by the European Medicines Agency, correlated with R2 of 0.18 and 0.031 to measured ones for Denmark and Finland, respectively and the predicted data were significantly higher than the measured ones. These correlations improved substantially to R2 of 0.72 and 0.74 after adjusting for estimated human excretion rates and further to R2 = 0.91 and 0.78 with the inclusion of removal rates in WWTPs. Temporal analysis of compound variations in a closely monitored WWTP showed minimal fluctuation over days and weeks for most compounds but revealed weekly shifts in iodinated X-ray contrast media due to emergency-only operations at X-ray clinics during weekends and an abrupt seasonal change for gabapentin. The findings underscore the limitations of current predictive models and findings (...) demonstrate how these methodologies can be refined by incorporating human pharmaceutical excretion/metabolization as well as removal in wastewater treatment plants to more accurately forecast pharmaceutical levels in aquatic environments.


Assuntos
Monitoramento Ambiental , Poluentes Químicos da Água , Poluentes Químicos da Água/análise , Preparações Farmacêuticas/análise , Monitoramento Ambiental/métodos , Águas Residuárias/química , Águas Residuárias/análise , Modelos Teóricos , Oceanos e Mares , Países Bálticos , Meios de Contraste/análise , Eliminação de Resíduos Líquidos
9.
J Hazard Mater ; 476: 135087, 2024 Sep 05.
Artigo em Inglês | MEDLINE | ID: mdl-38964042

RESUMO

Antiviral drugs are a cornerstone in the first line of antiviral therapy and their demand rises consistently with increments in viral infections and successive outbreaks. The drugs enter the waters due to improper disposal methods or via human excreta following their consumption; consequently, many of them are now classified as emerging pollutants. Hereby, we review the global dissemination of these medications throughout different water bodies and thoroughly investigate the associated risk they pose to the aquatic fauna, particularly our vertebrate relative fish, which has great economic and dietary importance and subsequently serves as a major doorway to the human exposome. Our risk assessment identifies eleven such drugs that presently pose high to moderate levels of risk to the fish. The antiviral drugs are likely to induce oxidative stress, alter the behaviour, affect different physiological processes and provoke various toxicological mechanisms. Many of the compounds exhibit elevated bioaccumulation potential, while, some have an increased tendency to leach through soil and contaminate the groundwater. Eight antiviral medications show a highly recalcitrant nature and would impact the aquatic life consistently in the long run and continue to influence the human exposome. Thereby, we call for urgent ecopharmacovigilance measures and modification of current water treatment methods.


Assuntos
Antivirais , Peixes , Poluentes Químicos da Água , Animais , Poluentes Químicos da Água/análise , Poluentes Químicos da Água/toxicidade , Medição de Risco , Humanos
10.
Environ Geochem Health ; 46(8): 288, 2024 Jul 06.
Artigo em Inglês | MEDLINE | ID: mdl-38970676

RESUMO

The combustion of coal in power plants releases significant amounts of polycyclic aromatic hydrocarbons (PAHs), which are highly toxic and carcinogenic. This study assesses the ecological and human health impacts of PAHs contamination from a coal-fired power plant over 8 years. The monitoring site selection considered the distance from the power plant and the prevailing wind direction in the investigated area. The results reveal that, during the monitoring period, PAH levels increased on average by 43%, 61%, and 37% in the zone of the prevailing wind direction, in the area proximate to the power plant, and the zone distant from it, respectively. The site, which has a radius of 4.5 km in the prevailing wind direction, exhibited the highest ecological and human health impacts. Additionally, a strong correlation was observed between environmental and human health impacts, depending on the distance from the power plant, particularly in areas with the prevailing wind direction. These insights contribute to a comprehensive understanding of the intricate dynamics linking power plant emissions, PAHs contamination, and their far-reaching consequences on the environment and human health.


Assuntos
Carvão Mineral , Monitoramento Ambiental , Hidrocarbonetos Policíclicos Aromáticos , Centrais Elétricas , Poluentes do Solo , Hidrocarbonetos Policíclicos Aromáticos/análise , Humanos , Monitoramento Ambiental/métodos , Poluentes do Solo/análise , Vento , Avaliação do Impacto na Saúde
11.
Environ Sci Technol ; 58(29): 13056-13064, 2024 Jul 23.
Artigo em Inglês | MEDLINE | ID: mdl-38900493

RESUMO

Rubber-derived chemicals (RDCs) originating from tire and road wear particles are transported into road stormwater runoff, potentially threatening organisms in receiving watersheds. However, there is a lack of knowledge on time variation of novel RDCs in runoff, limiting initial rainwater treatment and subsequent rainwater resource utilization. In this study, we investigated the levels and time-concentration profiles of 35 target RDCs in road stormwater runoff from eight functional areas in the Greater Bay Area, South China. The results showed that the total concentrations of RDCs were the highest on the expressway compared with other seven functional areas. N-(1,3-Dimethylbutyl)-N'-phenyl-p-phenylenediamine (6PPD), 6PPD-quinone, benzothiazole, and 1,3-diphenylguanidine were the top four highlighted RDCs (ND-228840 ng/L). Seasonal and spatial differences revealed higher RDC concentrations in the dry season as well as in less-developed regions. A lag effect of reaching RDC peak concentrations in road stormwater runoff was revealed, with a lag time of 10-90 min on expressways. Small-intensity rainfall triggers greater contamination of rubber-derived chemicals in road stormwater runoff. Environmental risk assessment indicated that 35% of the RDCs posed a high risk, especially PPD-quinones (risk quotient up to 2663). Our findings contribute to a better understanding of managing road stormwater runoff for RDC pollution.


Assuntos
Chuva , Borracha , Cidades , Poluentes Químicos da Água/análise , Monitoramento Ambiental , China
12.
Toxicol In Vitro ; 99: 105872, 2024 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-38851602

RESUMO

This study conducted a network pharmacology-based analysis to simultaneously discern a broad spectrum of potential environmental risks and health effects of antidepressants, a common class of pharmaceutical emerging contaminants (PECs) possessing a complex pharmacological profile, and in silico predict the adverse phenotypes potentially occurring in fish associated with exposure to antidepressants and their mixtures under realistic exposure scenarios. Results showed that 24 of the included 39 antidepressants had been detected worldwide in water environment across 50 countries. Using the environmentally realistic exposure scenario for China as an example, the predicted blood concentrations of antidepressant residues that were generated based on the Fish Plasma Model ranged from 37.89 (Alprazolam) to 16,772.05 (Sertraline) ng/L in exposed fish. Hazard-based bioactivity network without regard to concentration data was composed of 148 potential targets and 701 antidepressant-target interactions. After filtering each antidepressant-target interaction node using the predicted drug concentrations in the blood of fish under realistic exposure scenarios in China, an environmental risk-based network was refined and showed that 11 targets, including muscarinic acetylcholine receptor M1, alpha-2B adrenergic receptor, serotonin 2 A receptor, etc. might be modulated by antidepressants at concentrations equal to or below the environmental exposure levels and their mixtures in fish. Environmentally relevant concentrations of antidepressants in water samples from China might perturb the behavior, stress response, phototaxis, and development in exposed fish.


Assuntos
Antidepressivos , Peixes , Farmacologia em Rede , Poluentes Químicos da Água , Animais , Antidepressivos/toxicidade , Poluentes Químicos da Água/toxicidade , Medição de Risco
13.
Sci Total Environ ; 946: 174062, 2024 Oct 10.
Artigo em Inglês | MEDLINE | ID: mdl-38917906

RESUMO

The concern on the fate and distribution of contaminants of emerging concern (CECs) is a burning topic due to their widespread occurrence and potential harmful effects. Particularly, antibiotics have received great attention due to their implications in antimicrobial resistance occurrence. The impact of wastewater treatment plants (WWTP) is remarkable, being one of the main pathways for the introduction of CECs into aquatic systems. The combination of novel analytical methodologies and risk assessment strategies is a promising tool to find out environmentally relevant compounds posing major concerns in freshwater ecosystems impacted by those wastewater effluents. Within this context, a multi-target approach was applied in three Spanish river basins affected by different WWTP treated effluents for spatio-temporal monitoring of their chemical status. Solid phase extraction followed by ultra-high-performance liquid chromatography were used for the quantification of a large panel of compounds (n = 270), including pharmaceuticals and other consumer products, pesticides and industrial chemicals. To this end, water samples were collected in four sampling campaigns at three locations in each basin: (i) upstream from the WWTPs; (ii) WWTP effluent discharge points (effluent outfall); and (iii) downstream from the WWTPs (500 m downriver from the effluent outfall). Likewise, 24-h composite effluent samples from each of the WWTPs were provided in all sampling periods. First the occurrence and distribution of these compounds were assessed. Diverse seasonal trends were observed depending on the group of emerging compounds, though COVID-19 outbreak affected variations of certain pharmaceuticals. Detection frequencies and concentrations in effluents generally exceeded those in river samples and concentrations measured upstream WWTPs were generally low or non-quantifiable. Finally, risks associated with maximum contamination levels were evaluated using two different approaches to account for antibiotic resistance selection as well. From all studied compounds, 89 evidenced environmental risk on at least one occasion in this study.


Assuntos
Monitoramento Ambiental , Rios , Eliminação de Resíduos Líquidos , Águas Residuárias , Poluentes Químicos da Água , Rios/química , Poluentes Químicos da Água/análise , Medição de Risco , Águas Residuárias/química , Espanha , Estações do Ano
14.
Environ Sci Pollut Res Int ; 31(30): 43432-43450, 2024 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-38862805

RESUMO

The progress in chemical analytics and understanding of pesticide dynamics in surface waters allows establishing robust data on compounds with frequent exceedances of quality standards. The current chemical, temporal, and spatial coverage of the pesticide monitoring campaigns differs strongly between European countries. A questionnaire revealed differences in monitoring strategies in seven selected European countries; Nordic countries prioritize temporal coverage, while others focus on spatial coverage. Chemical coverage has increased, especially for non-polar classes like synthetic pyrethroids. Sweden combines monitoring data with agricultural practices for derived quantities, while the Netherlands emphasizes spatial coverage to trace contamination sources. None of the EU member states currently has established a process for linking chemical surface water monitoring data with regulatory risk assessment, while Switzerland has recently established a legally defined feedback loop. Due to their design and objectives, most strategies do not capture concentration peaks, especially 2-week composite samples, but also grab samples. Nevertheless, for substances that appear problematic in many data sets, the need for action is evident even without harmonization of monitoring programs. Harmonization would be beneficial, however, for cross-national assessment including risk reduction measures.


Assuntos
Monitoramento Ambiental , Praguicidas , Poluentes Químicos da Água , Praguicidas/análise , Poluentes Químicos da Água/análise , Europa (Continente) , Medição de Risco
15.
Artigo em Inglês | MEDLINE | ID: mdl-38860613

RESUMO

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 endeavor, 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 conveyed in two workshops held in February and November 2023, during which the agency communicated its findings to the technical-regulatory community. This article represents one of three articles that provide more detailed insights into the ERA propositions for all taxa. In this article, we summarize the proposals for aquatic organisms presented and discussed during the workshops, which can be used as an informational source by the technical-regulatory community. Integr Environ Assess Manag 2024;00:1-6. © 2024 The Author(s). Integrated Environmental Assessment and Management published by Wiley Periodicals LLC on behalf of Society of Environmental Toxicology & Chemistry (SETAC).

16.
Expert Opin Biol Ther ; 24(6): 529-542, 2024 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-38919146

RESUMO

INTRODUCTION: Recombinant viral-based gene therapy products, such as those incorporating adeno-associated viruses (AAVs), fall under the category of genetically modified organisms (GMOs). The European Union (EU) countries and Japan must obtain environmental risk assessment (ERA) approval for the use of GMOs before starting any clinical trials. It has been reported that the development of GMO-containing products in these two regions encounters several regulatory obstacles due to the longer regulatory procedures and document preparation for ERA. AREAS COVERED: In this article, we comparatively analyzed the ERA document requirements in the EU and Japan for AAV-based recombinant medicinal products to highlight the differences in the context of potential future attempts of convergence. Additionally, we analyzed non-clinical and clinical shedding data requirements, which are key components of ERA reviews in the EU and Japan. Lastly, we compared the containment measures to minimize the spread of GMOs in the environment in the EU and Japan. EXPERT OPINION: Based on our comparative analysis, we present several policy recommendations of standardizing and simplifying the application materials and procedures for the ERA regulations on GMOs in the EU and Japan in the mid-, and long-term timeframe to achieve global regulatory convergence.


Assuntos
Dependovirus , União Europeia , Vetores Genéticos , Japão , Dependovirus/genética , Humanos , Terapia Genética/legislação & jurisprudência , Medição de Risco , Organismos Geneticamente Modificados
17.
Environ Geochem Health ; 46(7): 220, 2024 Jun 07.
Artigo em Inglês | MEDLINE | ID: mdl-38849607

RESUMO

The aim of the study was to determine the content and leachability of Sr in ashes obtained through combusting municipal waste in household furnaces. The waste had been collected as a mixed stream and as separate fractions (i.e. furniture, sponges, waste paper, PCV packaging, plastic-coated paper cartons, imitation leather, rubber, textiles and polystyrene). Using single-step chemical extractions, (HCl + HNO3, H2O, 0.01 M CaCl2, 0.1 M CH3COOH), we determined the total content of Sr (TC) and proportions of the following fractions: water-leachable, phytoavailable and easily soluble and bound to carbonates. We also analyzed the effect of reducing pH in the extraction solutions on St leachability from the study material. The study showed that Sr concentration in ash generated from the combustion of conventional fuels, alternative fuels and municipal waste ranged from 114 to 1006 mg/kg. The largest amounts of Sr were found in ash generated from the combustion of alternative fuels (coal pellets 488-1006 mg/kg), conventional fuels (hard coal 430-670 mg/kg) and mixed waste (237-825 mg/kg). The most mobile fraction of Sr (water-leachable) comprised from 1.3% to nearly 91% TC; the phytoavailable fraction and the ion-exchange and carbonate-bound fraction comprised 3-92% TC and 9-72% TC, respectively. We also found that the greatest pH reductions do not always entail the greatest amounts of extracted Sr. A much more significant factor in this respect is the mineral and chemical composition of primary materials, which can buffer changes in pH. The Risk Assessment Code (RAC) values pointed to a varied environmental risk and the highest RAC values (> 70) were found for coal pellets, wood pellets, straw, rubber and plastic containers for mixed oils.


Assuntos
Incineração , Estrôncio , Estrôncio/análise , Estrôncio/química , Concentração de Íons de Hidrogênio , Resíduos Sólidos/análise , Poluentes Químicos da Água/análise
18.
Chemosphere ; 362: 142628, 2024 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-38885764

RESUMO

In the last years, issues related to intensive agriculture have been found in protected areas potentially harming wildlife. This study aimed to analyze a wide range of pesticides in water and sediments of two protected areas namely Doñana Natural Park (DNP) and Tablas de Daimiel National Park (TDNP) performing an environmental risk assessment in order to highlight potential risks to living organisms derived from pesticide burden. Higher pesticide load was found in DNP than TDNP with similar distribution profiles, with pyrethroid insecticides (PYRs) the main detected class. Particularly problematic are two PYRs, cyhalothrin and fenvalerate, which were detected at high concentrations that can pose a high risk to aquatic organisms. In addition, despite being detected at lower concentrations, the presence of chlorpyrifos, cypermethrin, and permethrin in water, and of chlorpyrifos, dicofol, and diflufenican in sediments, must be taken into account due to their potential risks for aquatic organisms. Moreover, some banned pesticides such as dimethoate, terbutryn, diazinon, and tricyclazol were detected in water at levels which deserve further investigation to assess their potential sources, including potential illegal practices.


Assuntos
Monitoramento Ambiental , Sedimentos Geológicos , Praguicidas , Piretrinas , Poluentes Químicos da Água , Sedimentos Geológicos/química , Poluentes Químicos da Água/análise , Praguicidas/análise , Espanha , Medição de Risco , Piretrinas/análise , Clorpirifos/análise , Nitrilas/análise
19.
Transgenic Res ; 33(4): 243-254, 2024 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-38902591

RESUMO

Insect-protected soybean (SIP) that produces the Cry1A.105 and Cry2Ab2 insecticidal crystal proteins has been developed to provide protection from feeding damage caused by targeted lepidopteran insect pests. Typically, as part of environmental risk assessment (ERA), plant characterization is conducted, and the data submitted to regulatory agencies prior to commercialization of genetically modified (GM) crops. The objectives of this research were to: (a) compare soybean with and without the SIP trait in plant characterization field trials designed to fulfill requirements for submissions to global regulatory agencies and address China-specific considerations and (b) compare risk assessment conclusions across regions and the methodologies used in the field trials. The soybean with and without the SIP trait in temperate, tropical, and subtropical germplasm were planted in replicated multi-location trials in the USA (in 2012 and 2018) and Brazil (in 2013/2014 and 2017/2018). Agronomic, phenotypic, plant competitiveness, and survival characteristics were assessed for soybean entries with and without the SIP trait. Regardless of genetic background, growing region, season, or testing methodology, the risk assessment conclusions were the same: the evaluated insect-protected soybean did not differ from conventional soybean in evaluated agronomic, phenotypic, competitiveness, and survival characteristics indicating no change in plant pest/weed potential. These results reinforce the concept of data transportability across global regions, different seasons, germplasm, and methodologies that should be considered when assessing environmental risks of GM crops.


Assuntos
Glycine max , Plantas Geneticamente Modificadas , Glycine max/genética , Glycine max/parasitologia , Glycine max/crescimento & desenvolvimento , Animais , Plantas Geneticamente Modificadas/genética , Plantas Geneticamente Modificadas/crescimento & desenvolvimento , Endotoxinas/genética , Brasil , Controle Biológico de Vetores , Proteínas Hemolisinas/genética , Produtos Agrícolas/genética , Insetos/genética , Insetos/patogenicidade , Lepidópteros/patogenicidade , Lepidópteros/genética , Proteínas de Bactérias/genética , Toxinas de Bacillus thuringiensis/genética
20.
Sci Total Environ ; 934: 173139, 2024 Jul 15.
Artigo em Inglês | MEDLINE | ID: mdl-38744394

RESUMO

The global surge in pharmaceutical consumption, driven by increasing population and the demand for animal proteins, leads to the discharge of diverse pollutants, including antibiotic residues, into water bodies. Sulfonamides, being water-soluble compounds, can readily enter surface run-off, posing potential risks to non-target species despite their low environmental concentrations. Latin America has implemented intensive production systems highly dependent on antimicrobials for productivity and animal health, yet there is a paucity of information regarding their concentration in the region. The objective of this study was to evaluate the presence of sulfonamides in water and sediment samples and assess their potential ecological risks through an environmental risk assessment. The Río de la Plata basin collects the waters of the Paraguay, Paraná, and Uruguay rivers, together with their tributaries and various wetlands, passing through the provinces in Argentina known for their significant animal husbandry production. Two sampling campaigns were carried out for sediment, while only one campaign was conducted for surface waters. The samples were analyzed by high performance liquid chromatography tandem mass-spectrometry (HPLC-MS/MS). None of the examined sulfonamide antibiotics were detected in the sediment samples from both sampling campaigns. In contrast, sulfadiazine (95 %), sulfamethoxazole (91 %), and sulfathiazole (73 %) were detected in the water samples. Sulfadiazine was found in the concentration range of 8 to 128 ng/L, while sulfamethoxazole and sulfathiazole were observed at concentrations ranging from 3.0 to 32.5 ng/L and 2.9 to 8.1 ng/L, respectively. Based on the environmental risk assessment conducted using the sulfonamide concentrations, most samples indicated a medium risk for aquatic biota, with only one sample surpassing the high-risk threshold. This study represents the first report presenting data on the presence of sulfonamide antibiotics in the aquatic environment of Argentina.


Assuntos
Monitoramento Ambiental , Sulfonamidas , Poluentes Químicos da Água , Argentina , Medição de Risco , Poluentes Químicos da Água/análise , Sulfonamidas/análise , Antibacterianos/análise , Rios/química , Sedimentos Geológicos/química , Espectrometria de Massas em Tandem
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