Search

As part of the US Army Corps of Engineers’ mission to evaluate and move dredged material (DM) to maintain navigation channels, environmental evaluation of the prospective material is required by the Code of Federal Regulations. While existing guidance manuals provide useful guidance to DM regulators, they are over 30 years old and not reflective of the latest science. However, efforts to update procedures and publish the documents individually or as a combined dredging manual have been thus far unsuccessful. These issues, coupled with a lack of consistent reporting and decision documentation, lead to delays arising from challenges addressing project-specific issues not clearly covered within the existing guidance, revisiting previously resolved issues or negotiating disputes between permitting authorities. This technical report provides a path toward modernization of the environmental compliance aspects of DM evaluation guidance in part through software executables guiding the management and decision process and through a structured, evidence-based approach. The value added is an updated approach to DM testing and evaluation decisions.

The enhanced understanding of nanomaterials properties and processing has led to increased use of nanotechnologies, which has also led to greater scrutiny on the commercialization and acquisition of emerging nanoenabled technologies. Caused by knowledge gaps on the unique behaviors, risks, and liabilities of novel engineered nanomaterials, this caution, when not evidence based, slows production and stifles innovation. Reducing the uncertainty surrounding the environmental risks and benefits of nanoenabled technologies, including their resilience in harsh environments, will speed the development and transition of advanced material technologies. In this work, a multifaceted research program generated data and processes to reduce that environmental uncertainty. Specifically, this case study examined printed, nanoenabled environmental sensors and their components to develop toxicological data and parameterize a life-cycle assessment. The study tested the sensors’ resilience in environmental weathering studies that considered both the potential release of the ingredient nanomaterials and the performance of the sensors after exposure to several harsh environmental climates and then created life-cycle inventories to determine environmental impact and reduce cost of research and development. Finally, this case study developed software tools to mitigate the cost of research and provide a framework for presenting toxicology data.

The use of engineered nanomaterials (ENMs) in consumer products has expanded rapidly, revealing both innovative improvements over conventional materials, and the potential for novel risks to human health and the environment. As the number of new nano-enabled products and the volume of toxicity data on ENMs continues to grow, regulatory agencies like the U.S. Consumer Product Safety Commission (CPSC) – a small, independent federal agency responsible for protecting consumers from unreasonable risks associated with product use – will require the ability to screen and group a diverse array of nano-enabled consumer products based on their potential risks to consumers. Such prioritization would allow efficient allocation of limited resources for subsequent testing and evaluation of high-risk products and materials. To enable this grouping and prioritization for further testing, we developed a framework that establishes a prioritization score by evaluating a nano-enabled product's potential hazard and exposure, as well as additional consideration of regulatory importance. We integrate the framework into a pilot version software tool and, using a hypothetical case study, we demonstrate that the tool can effectively rank nano-enabled consumer products and can be adjusted for use by agencies with different priorities. The proposed decision-analytical framework and pilot-version tool presented here could enable a regulatory agency like the CPSC to triage reported safety concerns more effectively and allocate limited resources more efficiently.

In 2018, the US Army Engineer Research and Development Center partnered with the US Army Corps of Engineers–Buffalo District, the US Environmental Protection Agency, Bowling Green State University, and the Cawthron Institute to host a workshop focused on benthic and sediment-associated cyanobacteria and cyanotoxins, particularly in the context of harmful algal blooms (HAB). Technical sessions on the ecology of benthic cyanobacteria in lakes and rivers; monitoring of cyanobacteria and cyanotoxins; detection of benthic and sediment-bound cyanotoxins; and the fate, transport, and health risks of cyanobacteria and their associated toxins were presented. Research summaries included the buoyancy and dispersal of benthic freshwater cyanobacteria mats, the fate and quantification of cyanotoxins in lake sediments, and spatial and temporal variation of toxins in streams. In addition, summaries of remote sensing methods, omic techniques, and field sampling techniques were presented. Critical research gaps identified from this workshop include (1) ecology of benthic cyanobacteria, (2) identity, fate, transport, and risk of cyanotoxins produced by benthic cyanobacteria, (3) standardized sampling and analysis protocols, and (4) increased technical cooperation between government, academia, industry, nonprofit organizations, and other stakeholders. Conclusions from this workshop can inform monitoring and management efforts for benthic cyanobacteria and their associated toxins.

This factsheet details the research and services available from the US Army Engineer Research and Development Center–Environmental Laboratory’s Harmful Algal Blooms team.

The need to prevent possible adverse environmental health impacts resulting from synthetic biology (SynBio) products is widely acknowledged in both the SynBio risk literature and the global regulatory community. To-date, however, discussions of potential risks of SynBio products have been largely speculative, and the limited attempts to characterize the risks of SynBio products have been non-uniform and entirely qualitative. As the SynBio discipline continues to accelerate and bring forth novel, highly-engineered life forms, a standardized risk assessment framework will become critical for ensuring that the environmental risks of these products are characterized in a consistent, reliable, and objective manner that incorporates all SynBio-unique risk factors. In their current forms, established risk assessment frameworks – including those that address traditional genetically modified organisms – fall short of the features required of this standard framework. To address this gap, we propose the Quantitative Risk Assessment Method for Synthetic Biology Products (QRA-SynBio) – an incremental build on established risk assessment methodologies that supplements traditional paradigms with the SynBio risk factors that are currently absent, and necessitates quantitative analysis for more transparent and objective risk characterizations. We demonstrate through a hypothetical case study that the proposed framework facilitates defensible quantification of the environmental risks of SynBio products in both foreseeable and hypothetical use scenarios. Additionally, we show how the quantitative nature of the proposed method can promote increased experimental investigation into the true likelihood of hazard and exposure parameters and highlight the most sensitive parameters where uncertainty should be reduced, ultimately leading to more targeted SynBio risk research and yielding more precise characterizations of risk.

Novel materials with unique or enhanced properties relative to conventional materials are being developed at an increasing rate. These materials are often referred to as advanced materials (AdMs) and they enable technological innovations that can benefit society. Despite their benefits, however, the unique characteristics of many AdMs, including many nanomaterials, are poorly understood and may pose environmental safety and occupational health (ESOH) risks that are not readily determined by traditional risk assessment methods. To assess these risks while keeping up with the pace of development, technology developers and risk assessors frequently employ risk-screening methods that depend on a clear definition for the materials that are to be assessed (e.g., engineered nanomaterial) as well as a method for binning materials into categories for ESOH risk prioritization. The term advanced material lacks a consensus definition and associated categorization or grouping system for risk screening. In this study, we aim to establish a practitioner-driven definition for AdMs and a practitioner-validated framework for categorizing AdMs into conceptual groupings based on material characteristics. Results from multiple workshops and interviews with practitioners provide consistent differentiation between AdMs and conventional materials, offer functional nomenclature for application science, and provide utility for future ESOH risk assessment prioritization. The definition and categorization framework established here serve as a first step in determining if and when there is a need for specific ESOH and regulatory screening for an AdM as well as the type and extent of risk-related information that should be collected or generated for AdMs and AdM-enabled technologies.

The use of engineered nanomaterials (ENMs) in consumer products has expanded rapidly, revealing both innovative improvements over conventional materials, and the potential for novel risks to human health and the environment. As the number of new nano-enabled products and the volume of toxicity data on ENMs continues to grow, regulatory agencies like the U.S. Consumer Product Safety Commission (CPSC) – a small, independent federal agency responsible for protecting consumers from unreasonable risks associated with product use – will require the ability to screen and group a diverse array of nano-enabled consumer products based on their potential risks to consumers. Such prioritization would allow efficient allocation of limited resources for subsequent testing and evaluation of high risk products and materials. To enable this grouping and prioritization for further testing, we developed a framework that establishes a prioritization score by evaluating a nano-enabled product's potential hazard and exposure, as well as additional consideration of regulatory importance. We integrate the framework into a pilot-version software tool and, using a hypothetical case study, we demonstrate that the tool can effectively rank nano-enabled consumer products and can be adjusted for use by agencies with different priorities. The proposed decision-analytical framework and pilot-version tool presented here could enable a regulatory agency like the CPSC to triage reported safety concerns more effectively and allocate limited resources more efficiently.

This technical note synthesizes and disseminates results of a 2020 survey of USACE dredging program and project managers to identify and prioritize needs related to the modernization and streamlining of the dredged material assessment decision guidance pursuant to Section 404 of the Clean Water Act (CWA) and Section 103 of the Marine Protection Research and Sanctuaries Act (MPRSA). Priorities identified through the survey and subsequent follow-on interviews—together with advances in science and technology—will facilitate development of an electronic decision guidance tool to enable consistent, timely, and cost-effective dredged material management decisions. This tool will also facilitate a standardized database for ready access to historical data.

Fused filament fabrication (FFF) 3D printers are increasingly used in industrial, academic, military, and residential sectors, yet their emissions and associated user exposure scenarios are not fully described. Characterization of potential user exposure and environmental releases requires robust investigation. During operation, common FFF 3D printers emit varying amounts of ultrafine particles (UFPs) depending upon feedstock material and operation procedures. Volatile organic compounds associated with these emissions exhibit distinct odors; however, the UFP portion is largely imperceptible by humans. This investigation presents straightforward computational modeling as well as experimental validation to provide actionable insights for the proactive design of lower exposure spaces where 3D printers may be used. Specifically, data suggest that forced clean airflows may create lower exposure spaces, and that computational modeling might be employed to predict these spaces with reasonable accuracy to assist with room design. The configuration and positioning of room air ventilation diffusers may be a key factor in identifying lower exposure spaces. A workflow of measuring emissions during a printing process in an ANSI/CAN/UL 2904 environmental chamber was used to provide data for computational fluid dynamics (CFD) modeling of a 6 m2 room. Measurements of the particle concentrations in a Class 1000 clean room of identical geometry were found to pass the Hanna test for agreement between model and experimental data, validating the findings.

Synthetic biology has the potential for a broad array of applications. However, realization of this potential is challenged by the paucity of relevant data for conventional risk assessment protocols, a limitation due to to the relative nascence of the field, as well as the poorly characterized and prioritized hazard, exposure, and dose–response considerations associated with the development and use of synthetic biology-derived organisms. Where quantitative risk assessment approaches are necessarily to fulfill regulatory requirements for review of products containing genetically modified organisms, this paper reviews one potential avenue for early-stage quantitative risk assessment for biosafety considerations of synthetic biology organism deployment into the environment. Building from discussion from a March 2018 US Army Engineer Research and Development Center workshop on developing such quantitative risk assessment for synthetic biology, this paper reviews the findings and discussion of workshop participants. This paper concludes that, while synthetic biology risk assessment and governance will continue to refine and develop in the coming years, a quantitative framework that builds from existing practice is one potentially beneficial option for risk assessors that must contend with the technology’s limited hazard characterization or exposure assessment considerations in the near term.

Current World Health Organization and Centers for Disease Control and Prevention guidance for the disposal of liquid waste from patients undergoing treatment for Ebola virus disease at hospitals in the U.S. is to manage patient excreta as ordinary wastewater without pretreatment. The potential for Ebolavirus transmission via liquid waste discharged into the wastewater environment is currently unknown, however. Possible worker inhalation exposure to Ebolavirus-contaminated aerosols in the sewer continues to be a concern within the wastewater treatment community. In this study, a quantitative microbial risk assessment was carried out to assess a sewer worker's potential risk of developing Ebola virus disease from inhalation exposure when performing standard occupational activities in a sewer line serving a hospital receiving Ebola patients where there is no pretreatment of the waste prior to discharge. Risk projections were estimated for four scenarios that considered the infectivity of viral particles and the degree of worker compliance with personal protective equipment guidelines. Under the least-favorable scenario, the median potential risk of developing Ebola virus disease from inhalation exposure to Ebolavirus-contaminated aerosols in the sewer is approximately 10-5.77 (with a first to third quartile range of 10-7.06 to 10-4.65), a value higher than many risk managers may be willing to accept. Although further data gathering efforts are necessary to improve the precision of the risk projections presented here, the results suggest that the potential risk that sewer workers face when operating in a wastewater collection system downstream from a hospital receiving Ebola patients warrants further attention, and that current authoritative guidance for Ebolavirus liquid waste disposal-to dispose in the sanitary sewer without further treatment-may be insufficiently protective of sewer worker safety.

Synthetic biology refers to the design and construction of new biological entities such as enzymes, genetic circuits, and cells or the redesign of existing biological systems (Keasling 2005). This capability is rooted in traditional molecular biology and engineering and incorporates newer techniques, including de novo DNA synthesis, CRISPR (clustered regularly interspaced short palindromic repeats)-based genome editing, and xenobiology. Synthetic biology, along with a wide range of emerging tools and techniques, will enable a new generation of biotechnology products of unprecedented scale and complexity over the next 5–10 years (NASEM 2017a).

Emerging technologies research often covers various perspectives in disciplines and research areas ranging from hard sciences, engineering, policymaking, and sociology. However, the interrelationship between these different disciplinary domains, particularly the physical and social sciences, often occurs many years after a technology has matured and moved towards commercialization. Synthetic biology may serve an exception to this idea, where, since 2000, the physical and the social sciences communities have increasingly framed their research in response to various perspectives in biological engineering, risk assessment needs, governance challenges, and the social implications that the technology may incur. This paper reviews a broad collection of synthetic biology literature from 2000-2016, and demonstrates how the co-development of physical and social science communities has grown throughout synthetic biology's earliest stages of development. Further, this paper indicates that future co-development of synthetic biology scholarship will assist with significant challenges of the technology's risk assessment, governance, and public engagement needs, where an interdisciplinary approach is necessary to foster sustainable, risk-informed, and societally beneficial technological advances moving forward.

The adverse outcome pathway (AOP) framework is a conceptual construct that mechanistically links molecular initiating events to adverse biological outcomes through a series of causal key events (KEs) that represent the perturbation of the biological system. Quantitative, predictive AOPs are necessary for screening emerging contaminants and potential substitutes to inform their prioritization for testing. In practice, they are not widely used because they can be costly to develop and validate. A modular approach for assembly of quantitative AOPs, based on existing knowledge, would allow for rapid development of biological pathway models to screen contaminants for potential hazards and prioritize them for subsequent testing and modeling. For each pair of KEs, a quantitative KE relationship (KER) can be derived as a response-response function or a conditional probability matrix describing the anticipated change in a KE based on the response of the prior KE. This transfer of response across KERs can be used to assemble a quantitative AOP. Here we demonstrate the use of proposed approach in two cases: inhibition of cytochrome P450 aromatase leading to reduced fecundity in fathead minnows and ionic glutamate receptor mediated excitotoxicity leading to memory impairment in rodents. The model created from these chains have value in characterizing the pathway and the potential or relative level of toxicological effect anticipated. This approach to simplistic, modular AOP models has wide applicability for rapid development of biological pathway models.

Although advanced materials (AdMs) are beneficial in many applications, questions remain as to whether they are more or less sustainable than the conventional materials that they may replace. Currently, there is no available tool to provide clarity to these questions. Traditional approaches for evaluating the sustainability of a chemical or material are usually not standardized, and as a result, the metrics used in sustainability measurements are subjective and often vary from assessor to assessor. Additionally, sustainability characterizations resulting from these approaches are typically presented qualitatively and are often vaguely drawn, making it difficult to confidently and transparently conclude that 1 material is more sustainable than another. This paper aims to address these gaps by enabling stakeholders involved in the production, use, or governance of AdMs to assess the sustainability of AdMs in a consistent, objective, and quantitative way using a multicriteria decision analysis (MCDA)-based model. The model proposed herein adapts a triple-bottom-line (TBL) framework from the Institution of Chemical Engineers (IChemE) and incorporates criteria weights identified through a stakeholder values assessment conducted by surveying AdM practitioners. Results from the stakeholder values assessment show that the perceived importance of the economic component of the TBL varies the most across stakeholders, and that practitioners providing responses from the perspective of a nongovernmental environmental advocacy group or a regulator of AdMs such as the United States Environmental Protection Agency were more likely to score and weigh economic indicators lower and environmental indicators higher compared to when responding from a business owner perspective. The resulting MCDA-based model allows stakeholders to assess the sustainability of an AdM or AdM-enabled product and compare it to product alternatives, predict how other stakeholders might score a product by identifying the extent to which components of the TBL are valued by other stakeholders, and identify which subcriteria contribute most to an improvement in a product's sustainability score. Integr Environ Assess Manag 2019;00:1-8. © 2019 SETAC.

The need to prevent possible adverse environmental health impacts resulting from synthetic biology (SynBio) products is widely acknowledged in both the SynBio risk literature and the global regulatory community. To-date, however, discussions of potential risks of SynBio products have been largely speculative, and the limited attempts to characterize the risks of SynBio products have been non-uniform and entirely qualitative. As the SynBio discipline continues to accelerate and bring forth novel, highly-engineered life forms, a standardized risk assessment framework will become critical for ensuring that the environmental risks of these products are characterized in a consistent, reliable, and objective manner that incorporates all SynBio-unique risk factors. In their current forms, established risk assessment frameworks – including those that address traditional genetically modified organisms – fall short of the features required of this standard framework. To address this gap, we propose the Quantitative Risk Assessment Method for Synthetic Biology Products (QRA-SynBio) – an incremental build on established risk assessment methodologies that supplements traditional paradigms with the SynBio risk factors that are currently absent, and necessitates quantitative analysis for more transparent and objective risk characterizations. We demonstrate through a hypothetical case study that the proposed framework facilitates defensible quantification of the environmental risks of SynBio products in both foreseeable and hypothetical use scenarios. Additionally, we show how the quantitative nature of the proposed method can promote increased experimental investigation into the true likelihood of hazard and exposure parameters and highlight the most sensitive parameters where uncertainty should be reduced, ultimately leading to more targeted SynBio risk research and yielding more precise characterizations of risk.

The fields of nanomedicine, risk analysis, and decision science have evolved considerably in the past decade, providing developers of nano-enabled therapies and diagnostic tools with more complete information than ever before and shifting a fundamental requisite of the nanomedical community from the need for more information about nanomaterials to the need for a streamlined method of integrating the abundance of nano-specific information into higher-certainty product design decisions. The crucial question facing nanomedicine developers that must select the optimal nanotechnology in a given situation has shifted from “how do we estimate nanomaterial risk in the absence of good risk data?” to “how can we derive a holistic characterization of the risks and benefits that a given nanomaterial may pose within a specific nanomedical application?” Many decision support frameworks have been proposed to assist with this inquiry; however, those based in multicriteria decision analysis have proven to be most adaptive in the rapidly evolving field of nanomedicine—from the early stages of the field when conditions of significant uncertainty and incomplete information dominated, to today when nanotoxicology and nano-environmental health and safety information is abundant but foundational paradigms such as chemical risk assessment, risk governance, life cycle assessment, safety-by-design, and stakeholder engagement are undergoing substantial reformation in an effort to address the needs of emerging technologies. In this paper, we reflect upon 10 years of developments in nanomedical engineering and demonstrate how the rich knowledgebase of nano-focused toxicological and risk assessment information developed over the last decade enhances the capability of multicriteria decision analysis approaches and underscores the need to continue the transition from traditional risk assessment towards risk-based decision-making and alternatives-based governance for emerging technologies.

Current World Health Organization and Centers for Disease Control and Prevention guidance for the disposal of liquid waste from patients undergoing treatment for Ebola virus disease at hospitals in the U.S. is to manage patient excreta as ordinary wastewater without pretreatment. The potential for Ebolavirus transmission via liquid waste discharged into the wastewater environment is currently unknown, however. Possible worker inhalation exposure to Ebolavirus-contaminated aerosols in the sewer continues to be a concern within the wastewater treatment community. In this study, a quantitative microbial risk assessment was carried out to assess a sewer worker's potential risk of developing Ebola virus disease from inhalation exposure when performing standard occupational activities in a sewer line serving a hospital receiving Ebola patients where there is no pretreatment of the waste prior to discharge. Risk projections were estimated for four scenarios that considered the infectivity of viral particles and the degree of worker compliance with personal protective equipment guidelines. Under the least-favorable scenario, the median potential risk of developing Ebola virus disease from inhalation exposure to Ebolavirus-contaminated aerosols in the sewer is approximately 10-5.77 (with a first to third quartile range of 10-7.06 to 10-4.65), a value higher than many risk managers may be willing to accept. Although further data gathering efforts are necessary to improve the precision of the risk projections presented here, the results suggest that the potential risk that sewer workers face when operating in a wastewater collection system downstream from a hospital receiving Ebola patients warrants further attention, and that current authoritative guidance for Ebolavirus liquid waste disposal-to dispose in the sanitary sewer without further treatment-may be insufficiently protective of sewer worker safety.