Proposal for an integrated approach for the assessment of cross-media aspects relevant for the determination of “best available techniques” bat in the european union

The EC Directive concerning integrated pollution prevention and control (IPPC Directive 96/61/EC) obliges all Member States to make an integrated assessment of the impacts on the environment “as a whole”, as regards granting permission for and the operation of environmentally relevant industrial installations. The determination of “Best Available Techniques” BAT plays an essential role in the material transformation of the IPPC-Directive. An integrated approach for the assessment of cross-media aspects of techniques for the determination of BAT is outlined in this paper, which is grounded on the basic concept of Life Cycle Assessment (LCA), emphasising the need for decision support. The proposed assessment approach is applied to a case study sinter production in an integrated iron and steel works, which forms the base for several recommendations concerning further research.     

The European Union and the Marine Strategy Framework Directive: Continuing the Development of European Ocean Use Management

The European Union has been engaged in an effort to develop a marine strategy to protect the marine environment and a more encompassing integrated maritime policy that would provide a comprehensive system for the management of the uses of the marine areas of Europe. An earlier article by the author described the beginnings of this policy development; this article examines the subsequent 2008 Directive of the European Parliament and the Council, which establishes a framework for community action in the field of marine environmental policy. The Marine Strategy Framework Directive provides a plan of action with designated responsibilities and obligations and a schedule that is to be adhered to by member states and the European Commission. It represents a significant step in the European endeavor to advance ocean use management and sets the stage for future development of European marine policy.     

Internet-Based Integrated Environmental Assessment Using Ontologies to Share Computational Models

New advances in Internet technologies and computer modeling provide opportunities for collaborative systems to support research and development in the field of industrial ecology. In particular, new information technologies such as semantic search engines based on ontologies could help researchers to link fragments of knowledge generated at research centers from around the world. Using a storyline of four imaginary researchers who hope to find collaborators in order to develop their research findings, we illustrate two levels of a four-level architecture for an Internet-based knowledge integration and collaboration environment for integrated environmental assessment. The foundation of the proposed architecture is a belief that computational models are an effective medium for conveying expert knowledge of various phenomena. Drawing from this premise, the first level of the architecture stands on a base of computational models that in some way represent the expert knowledge of the model builder. At the second level, we provide markup and interface definition tools to describe the type of knowledge contained in each model, together with the types of information services that can be provided.
The results of research at these two levels of an Internet-based knowledge integration environment for integrated environmental assessment in industrial ecology are presented in this article. Our work on the third level of model searching and matching and the fourth level of parametric model integration and solving will be presented in subsequent articles.     

When the Background Matters: Using Scenarios from Integrated Assessment Models in Prospective Life Cycle Assessment

Prospective life cycle assessment (LCA) needs to deal with the large epistemological uncertainty about the future to support more robust future environmental impact assessments of technologies. This study proposes a novel approach that systematically changes the background processes in a prospective LCA based on scenarios of an integrated assessment model (IAM), the IMAGE model. Consistent worldwide scenarios from IMAGE are evaluated in the life cycle inventory using ecoinvent v3.3. To test the approach, only the electricity sector was changed in a prospective LCA of an internal combustion engine vehicle (ICEV) and an electric vehicle (EV) using six baseline and mitigation climate scenarios until 2050. This case study shows that changes in the electricity background can be very important for the environmental impacts of EV. Also, the approach demonstrates that the relative environmental performance of EV and ICEV over time is more complex and multifaceted than previously assumed. Uncertainty due to future developments manifests in different impacts depending on the product (EV or ICEV), the impact category, and the scenario and year considered. More robust prospective LCAs can be achieved, particularly for emerging technologies, by expanding this approach to other economic sectors beyond electricity background changes and mobility applications as well as by including uncertainty and changes in foreground parameters. A more systematic and structured composition of future inventory databases driven by IAM scenarios helps to acknowledge epistemological uncertainty and to increase the temporal consistency of foreground and background systems in LCAs of emerging technologies.     

Harmonization of regulations for invertebrate biocontrol agents in Europe: progress,problems and solutions

The use of non‐native invertebrate biological control agents (IBCAs) in Europe is not covered by a Directive equivalent to that which regulates biocontrol with microorganisms or the genetic modification of crop plants. Regulation is at the discretion of individual member states and largely derived from national legislation on pesticides, plant health or environmental protection. There is no EU country with regulation of IBCAs that requires information on the microbial symbiont content of candidate species, and in the absence of horizontal transfer under natural conditions, this policy is unlikely to change. Although there have been few reported negative effects linked to the import and release of IBCAs, a number of countries have introduced or revised their regulatory frameworks in recent years. This article reviews major developments in the regulation and environmental risk assessment (ERA) of IBCAs in Europe over the last 10 years including: the fragmented pattern of regulation between countries, variation in information requirements for release licences, format and methods of ERA for different taxonomic groups of IBCAs, use and updating of the European Plant Protection Organisation Positive List, sources of expert advice on ERA data, communication between IBCA regulators, and options for the provision of international leadership to coordinate regulatory and ERA‐related issues with IBCA‐based biocontrol in Europe.     

Applying Life Cycle Tools and Process Engineering to Determine the Most Adequate Treatment Process Conditions. A Tool in Environmental Policy (12 pp)

Background The analysis of a wastewater treatment technology, under a expanded boundaries system which includes both the technology and the inputs required for its operation, quantifies the overall environmental impact that may result from the treatment of a wastewater stream. This is particularly useful for environmental policy makers being that a expanded boundaries system tends to provide a holistic view. The former view can be highly enriched with the use of process engineering tools, such as mathematical process modelling, process design, performance assessment and cost optimised models. Main Features The traditional approach used to assess waste treatment technologies is contrasted with a life cycle analysis (LCA) approach. The optimal design of a granular activated carbon adsorption (GAC) process is used as a model system to demonstrate the advantages of LCA approaches over traditional approaches. Further sections of the paper describe a mathematical framework for the assessment of technologies, design considerations applied in the cost optimised carbon adsorption model, the use of LCA techniques to perform an inventory of all emissions associated to the process system and, some of its environmental impacts. Results Economic and environmental considerations regarding the optimum process design are introduced as a basis for decision towards the selection and operating conditions of wastewater treatment technologies. Moreover, the use of LCA has revealed that the environmental burden associated with the wastewater treatment may produce a higher environmental impact than one that can be caused by untreated discharges. Conclusion The paper highlights the string advantages that environmental policy makers may have by combining LCA and process engineering tools. Furthermore, this approach can be incorporated into other existing treatment processes or for process designers.     

Strategic Responses to Environmental Regulation in the U.K. Automotive Sector: The European Union End-of-Life Vehicle Directive and the Porter Hypothesis

As of 1 January 2006 all automotive OEMs (original equipment manufacturers) and component manufacturers operating within the European Union will need to comply with the End-of-Life Vehicle Directive (referred to hereafter as the EU ELV Directive). The EU ELV Directive compels all OEMs to take back and dismantle all motor vehicles for domestic use at the end of their useful lives. Each component part will then be either reused or recycled. To this end, the ultimate goal of the EU ELV Directive is that all motor vehicles for domestic use will have a reuse or recyclable content of 85% at the end of their useful lives, moving toward 95% by 2015. The burden of the EU ELV Directive falls on both the OEMs and their component manufacturers, forcing them to innovate and "design for disassembly." This being the case, it offers a unique real world example with which to test the Porter Hypothesis. Porter asserts that strict, correctly formulated environmental regulation can offer a firm secondary benefits through improved product design and the reduction of waste. This in turn allows the firm to offset the cost of compliance. Because the EU ELV Directive has been fashioned to force firms into a process of innovation and redesign, the magnitude of these so-called offsets can be judged. This article employs Rugman and Verbeke's 1998 strategic matrix of firm response to environmental regulation to examine qualitative details of the strategic response of automotive component manufacturers and OEMs in the United Kingdom to the demands of the directive to judge the volume of offsets generated. This analysis shows no support for the Porter Hypothesis and challenges the assumptions of Rugman and Verbeke's model.     

Extended Producer Responsibility for Waste Electronics: An Example of Printer Recycling in the United Kingdom

In February 2003, European Union (EU) policy makers implemented a Directive that will make producers responsible for waste electrical and electronic equipment at end-of-life (known as the "WEEE" Directive). Under this new legislation, producers are required to organize and finance the take-back, treatment, and recycling of WEEE and achieve mass-based recycling and recovery targets. This legislation is part of a growing trend of extended producer responsibility for waste, which has the potential to shift the world's economies toward more circular patterns of resource use and recycling. This study uses life-cycle assessment and costing to investigate the possible environmental effects of the WEEE Directive, based on an example of printer recycling in the United Kingdom.
For a total of four waste management scenarios and nine environmental impact categories investigated in this study, results varied, with no scenario emerging as best or worst overall compared to landfilling. The level of environmental impact depended on the type of material and waste management processes involved. Additionally, under the broad mass-based targets of the WEEE Directive, the pattern of relationships between recycling rates, environmental impacts, and treatment and recycling costs may lead to unplanned and unwanted results. Contrary to original EU assumptions, the use of mass-based targets may not ensure that producers adapt the design of their products as intended under producer responsibility.
It is concluded that the EU should revise the scope of consideration of the WEEE Directive to ensure its life-cycle impacts are addressed. In particular, specific environmental objectives and operating standards for treatment and recycling processes should be investigated as an alternative to mass-based recycling and recovery targets.     

On the Use of Mixture Toxicity Assessment in REACH and the Water Framework Directive: A Review

This review seeks to connect the scientific theory of mixture toxicity to its implementation within different regulatory frameworks. The aim is to demonstrate how mixture toxicity assessment can be more thoroughly integrated into the European chemical regulations, REACH, and the Water Framework Directive (WFD), using the experiences gained through other regulatory frameworks. The article consists of (1) an examination of the scientific underpinnings of the common mixture toxicity assessment methods; (2) a discussion of how these methods have been used in regulatory frameworks; and (3) a discussion of how the methods could be applied within REACH and the WFD. It is concluded that concentration addition should be applied as a default model for mixture toxicity assessment. Furthermore, it is concluded that REACH and the WFD only include mixture toxicity assessments in specific situations. However, it is shown that it is scientifically feasible and regulatorally practicable to integrate a more holistic mixture toxicity approach into both legislations. In this connection, the experience gained from the U.S. frameworks on mixture toxicity assessment could be useful. The construction of a database that includes data on chemicals in the European environment could be used for mixture toxicity assessment of the chemicals with individual PEC/PNECs > 0.1.     

Assessment of quality of three marine benthic habitat types in northern Baltic Sea

The European Union Habitats Directive (HD) obliges member states to assess the conservation status of marine habitat types but no explicit methodologies for assessing the quality of habitats have been stated in the directive or accompanying documents. In this study, a system was developed to assess the structure and functioning of three important marine habitat types in the Estonian sea area: sandbanks (HD code 1110), mudflats (1140), and reefs (1170). The assessment system includes a list of ecological criteria and favourable reference values together with procedural rules and field sampling locations. The habitat types listed in the HD are broadly defined and may encompass different communities depending upon distinct environmental gradients. By considering these environmental gradients the habitat types reefs and sandbanks were zoned and the assessment criteria and corresponding favourable reference values were defined separately for each zone. A set of several metrics like benthos indices, community variables, presence of sensitive or typical species, proportions of functional or taxonomic groups were tested as potential criteria for determining habitat quality. The most appropriate criteria were selected for incorporation into the assessment system based on ecological eligibility, suitability to local conditions, occurrence rates of benthic species, responses to disturbances, statistical properties of distribution of measured values, and practical considerations. Extensive benthos database (records from the whole Estonian sea area, 1995–2014) was used to calculate values of criteria to support the selection of criteria and to derive reference values. In order to fully take into account their crucial role in maintaining the structure and functioning of habitats, the criteria on habitat-forming species were assigned higher hierarchical order in the assessment scheme compared to other criteria. Special field works were carried out to assess the status of the three habitat types in 2015. The quality of all three monitored habitats was assessed to be in a favourable status. Additionally, the distributions of the three habitat types were mapped. To date, this is the first study in the Baltic Sea region that formulates HD compliant explicit criteria, reference values, and assessment procedures for several marine habitat types. The main challenges of the study were to derive assessment criteria and favourable reference values that are ecologically relevant and practically feasible.     

Screening of Metals in Waste Electrical and Electronic Equipment Using Simple Assessment Methods

Abstract: Various toxic, useful, and/or scarce metals in waste electric and electronic equipment (WEEE) have rarely been assessed due to low data availability, except for the four metals regulated by the European Union's Directive on the Restriction of Hazardous Substances (RoHS). This article describes the results of screening 36 metals in WEEE using simple assessment methods for cases where the decision makers do not know for which substances in a product countermeasures should be taken and where data cannot be easily obtained. First, this study examines the decision-making process and prerequisites for screening, classifies existing assessment methods, and presents three simple indices for screening (resource consumption, water pollution affecting human health, and aquatic biota conservation) so that screening can be readily started for many (20–36) metals. Following this, a case study is conducted for waste TV sets, revealing which metal in which product module or component should be targeted by environmental countermeasures. Finally, the screening results are compared with those of six other methods using diagrams devised to indicate the superiority of screening methods, and several screening techniques are discussed. The conclusions are that the EU RoHS Directive does not necessarily cover all of the toxic metals that could be of concern and the screening methods presented could help identify such metals; the selection of methods is critical; and a more detailed method does not necessarily provide more accurate results.     

Gene therapy legislation in The Netherlands

Several regulatory organisations are involved in the assessment of clinical gene therapy trials involving genetically modified organisms (GMOs) in The Netherlands. Medical, ethical and scientific aspects are, for instance, evaluated by the Central Committee on Research Involving Human Subjects (CCMO). The Ministry of Housing, Spatial Planning and the Environment (VROM) is the competent authority for the environmental risk assessment according to the deliberate release Directive 2001/18/EC. A Gene Therapy Office has been established in order to streamline the different national review processes and to enable the official procedures to be completed as quickly as possible. Although the Gene Therapy Office improved the application process at the national level, there is a difference of opinion between the EU member states with respect to the EU Directive according to which gene therapy trials are assessed, that urges for harmonisation. This review summarises the gene therapy legislation in The Netherlands and in particular The Netherlands rationale to follow Directive 2001/18/EC for the environmental risk assessment.     

Life Cycle Assessment of Water Production Technologies - Part 1: Life Cycle Assessment of Different Commercial Desalination Technologies (MSF,MED, RO) (9 pp)

- Preamble. This series of two papers analyses and compares the environmental loads of different water production technologies in order to establish, in a global, rigorous and objective way, the less aggressive technology for the environment with the present state of the art of the technology. Further, it is also presented an estimation of the potential environmental loads that the considered technologies could provoke in future, taking into account the most suitable evolution of the technology. - Part 1 presents the assessment of most commercial desalination technologies which are spread worldwide: Reverse Osmosis, Multi Effect Desalination and Multi Stage Flash. Part 2 presents the comparative LCA analysis of a big hydraulic infrastructure, as is to be found in the Ebro River Water Transfer project, with respect to desalination. - DOI: http://dx.doi.org/10.1065/lca2004.09.179.1 - Intention, Goal and Background. In this paper, some relevant results of a research work are presented, the main aim of which consists of performing the environmental assessment of different water production technologies in order to establish, in a global, rigorous and objective way, the less aggressive technology for the environment of potable water supply to the end users. That is, the scope of this paper is mostly oriented to the comparative Life Cycle Assessment of different water production technologies instead of presenting new advancements in the LCA methodology. In Part 1, the environmental loads associated with the most widespread and important commercial desalination technologies all over the world - Reverse Osmosis (RO), Multi Effect Desalination (MED) and Multi Stage Flash (MSF) – are compared. The assessment technique is the Life Cycle Analysis (LCA), which includes the entire life cycle of each technology, encompassing: extraction and processing raw materials, manufacturing, transportation and distribution, operation and final waste disposal.- Methods and Main Features. The software SimaPro 5.0, developed by Dutch PRé Consultants, has been used as the analysis tool, because it is a well known, internationally accepted and validated tool. Different evaluation methods have been applied in the LCA evaluation: CML 2 baseline 2000, Eco-Points 97 and Eco-Indicator 99. Data used in the inventory analysis of this Part 1 come from: a) existing plants in operation; b) data bases implemented in the SimaPro 5.0 software -BUWAL 250, ETH-ESU 96, IDEMAT 2001. Different scenarios have been analyzed in both parts in order to estimate, not only the potential of reduction of the provoked environmental loads with the present state of the art of technology, but also the most likely future trend of technological evolution. In Part 1, different energy production models and the integration of desalination with other productive processes are studied, while the effect of the most likely technological evolution in the midterm, and the estimation of the environmental loads to the water transfer during drought periods are considered in Part 2. Results and Discussion The main contribution to the global environmental impact of desalination technologies comes from the operation, while the other phases, construction and disposal, are almost negligible when compared to it. Energy is very important in desalination, for this reason the environmental loads change a lot depending on the technology used for providing the energy used in the desalination process. Among the different analyzed technologies, RO is the least aggressive desalination technology (one order of magnitude lower than the thermal processes, MSF and MED) for the environment. When integrating thermal desalination with other productive processes taking advantage of the residual heat, the environmental loads of thermal desalination technologies is highly reduced, obtaining similar loads to that of RO. The environmental loads of desalination technologies are significantly reduced when an energy model based on renewable energies is used. Taking into account the technological evolution, which is experiencing the RO, a reduction of its environmental load by about 40% is to be expected in the mid-term. Conclusion The main conclusion of Part 1 is that, with the present state of the art of the technology, RO is clearly the desalination technology with a reduced environmental load (one order of magnitude lower than the thermal processes, MSF and MED). In the case of thermal desalination technologies, their environmental load can be highly reduced (about 1,000 times less) when integrated with other industrial processes. In the case of RO, the scores and the airborne emissions obtained from an electricity production model based on renewable energies are about 65-70 times lower than those obtained when the electricity production model is mainly based on fossil fuels. Recommendations and Outlook Although desalination technologies are energy intensive and provoke an important environmental load, they present a high potential in being reduced since: a) in the mid-term, it is to be expected that the different technologies could improve their efficiency significantly, b) the environmental loads would be highly reduced if the energy production models were not mainly based on fossil fuels and c) the energy consumption, particularly in the case of thermal desalination, can be drastically reduced when integrating desalination with other productive processes. The results presented in this paper indicate that a very interesting and promising field of research is available in order to reduce the environmental load of these vigorous and increasing desalination technologies.     

Regulation of herbal medicinal products in the EU: an up-to-date scientific review

A new European legislation on herbal medicinal products (HMPs) was developed, in order to harmonise the use of HMPs in the 28 member states of the European Union, according to Directive 2004/24/EC which amended the basic legislation laid down in Directive 2001/83/EC. The objective of this legislation was to ensure the future existence of such products and to consider particular characteristics during the assessment of their quality, efficacy and safety, having defined two categories for herbal medicines: (a) well-established use HMPs, which can be granted a marketing authorisation; and (b) traditional herbal medicinal products which can be granted a registration based on their long-standing safe and efficient use. The Committee on Herbal Medicinal Products was established at the European Medicines Agency in 2004, in order mainly to provide community monographs and list entries on herbal substances and preparations. 120 monographs have been published since then, which offer a scientific and regulatory standard for their safety and efficacy, during their use as medicinal products. The HMPs can be placed in the market after quality, efficacy, and safety have been assessed according to the provisions of the legislation (Directive 2004/24/EC and Directive 2001/83/EC), with adequate labeling information to patients and health care professionals, distinguishing them from other product categories containing herbs like: foods, food supplements, medical devices and cosmetics.     

Towards an Integrated Regional Materials Flow Accounting Model

A key challenge in attaining regional sustainability is to reduce both the direct and the indirect environmental impacts associated with economic and household activity in the region. Knowing what these flows are and how they change over time is a prerequisite for this task.
This article describes the early development of an integrated regional materials flow accounting framework. The framework is based on a hybrid (material and economic) multiregional input-output model. Using readily available economic and materials data sets together with transport and logistics data, the framework attempts to provide estimates of household resource flows for any U.K. region at quite detailed levels of product and material disaggregation. It is also capable of disaggregating these flows according to specific socioeconomic criteria such as income level or occupation of the head of household. Allied to appropriate energy and life-cycle assessment data sets, the model could, in addition, be used to map both direct and indirect environmental impacts associated with these flows.
The benefits of such an approach are likely to be a considerable reduction of uncertainties in (1) our knowledge of the household metabolism, and hence our predictions of regional household waste generation; (2) our assessment of the impacts of contemplated changes in industrial process siting, and thereby on other aspects of local and regional planning; and (3) our understanding of the impacts of changes in the pattern of demand for different materials and products. It is concluded that the use of such an integrated assessment tool has much to contribute to the debate on regional sustainability.     

From Life Cycle Assessment to Life Cycle Management

Life cycle assessment (LCA) is a widely accepted methodology to support decision‐making processes in which one compares alternatives, and that helps prevent shifting of environmental burdens along the value chain or among impact categories. According to regulation in the European Union (EU), the movement of waste needs to be reduced and, if unavoidable, the environmental gain from a specific waste treatment option requiring transport must be larger than the losses arising from transport. The EU explicitly recommends the use of LCA or life cycle thinking for the formulation of new waste management plans. In the last two revisions of the Industrial Waste Management Programme of Catalonia (PROGRIC), the use of a life cycle thinking approach to waste policy was mandated. In this article we explain the process developed to arrive at practical life cycle management (LCM) from what started as an LCA project. LCM principles we have labeled the “3/3” principle or the “good enough is best” principle were found to be essential to obtain simplified models that are easy to understand for legislators and industries, useful in waste management regulation, and, ultimately, feasible. In this article, we present the four models of options for the management of waste solvent to be addressed under Catalan industrial waste management regulation. All involved actors concluded that the models are sufficiently robust, are easy to apply, and accomplish the aim of limiting the transport of waste outside Catalonia, according to the principles of proximity and sufficiency.     

Evaluating Environmental Performance of Pulp and Paper Manufacturing Using the Analytic Hierarchy Process and Life-Cycle Assessment

This article addresses the need for a structured and compre-hensive methodology for assessing the environmental perfor-mance of manufacturing processes. The analytic hierarchy pro-cess (AHP) is used as the basic framework for analyzing environmental impacts and improvement options following a streamlined life-cycle assessment (LCA) approach that is fo-cused on the manufacturing operation. The multicriteria de-cision analysis approach of the AHP is consistent with the LCA concept because the environmental factors can be hierarchi-cally structured into impacts and improvement options. Its po-tential as a valuation tool for impact and improvement assess-ment addresses both qualitative and quantitative issues in environmental decision making.
Through application to a pulp and paper manufacturing case study, the viability of the AHP for evaluating environmen-tal impacts and prioritizing process improvement options rela-tive to these impacts is demonstrated. AHP was used to pro-vide a quantitative tool for the design of a set of weighting factors for impact and improvement analyses.     

Survey Insights into Weighting Environmental Damages: Influence of Context and Group

When one models impact pathways due to stressors that are caused by the provision of product systems, it results in indicators for environmental damages. These indicators are incommensurable and cannot be compared per se. For example, the statistical life years lost for a human population cannot necessarily be compared with the potentially affected fraction of species within an ecosystem. However, some decision makers who use life-cycle assessment (LCA) prefer a single index, because it facilitates interpretation better than a multi-indicator system. This requires a method for aggregating environmental damages of differing types, thereby confronting LCA with a valuation problem.
The article describes a nonmonetary approach to valuation in LCA that incorporates the findings of a survey among LCA practitioners and users. The survey focuses on the weighting of three safeguard subjects for Eco-indicator 99, a damage-oriented impact-assessment method: human health, ecosystem quality, and resources. Of particular interest here is what influence the context provided in the survey (framing) and an individual's characteristics have on his or her weighting of environmental damages. The results indicate that damages on the European level are easier to compare than damages on a micro level. Additionally, although only half of the survey participants could be classified unequivocally into one of three cultural perspectives, each perspective rated the damage categories presented to them significantly differently from the others. Our conclusions were that framing effects need to be more carefully considered in weighting procedures and that weighting preferences vary significantly according to a group's archetypical attitudes.     

Approaches for Integrated Risk Assessment

Recognizing the need to enhance the effectiveness and efficiency of risk assessments globally, the World Health Organization's International Programme on Chemical Safety, the U.S. Environmental Protection Agency, the European Commission, and the Organization for Economic Cooperation and Development developed a collaborative partnership to foster integration of assessment approaches used to evaluate human health and ecological risks. The objectives of this effort included: improving understanding of the benefits of integration, identifying obstacles to the integration process, and engaging key agencies, organizations, and scientific societies to promote integration. A framework with supporting documentation was developed to describe an approach for integration. Four case studies were constructed to illustrate how integrated risk assessments might be conducted for chemical and nonchemical stressors. The concepts and approaches developed in the project were evaluated in an international workshop. The goal of this effort was international acceptance of guidance for integrated risk assessment.