Relationships Between Animal Health Monitoring and the Risk Assessment Process

Risk assessment is part of the risk analysis process as it is used in veterinary medicine to estimate risks related to international trade and food safety. Data from monitoring and surveillance systems (MO&SS) are used throughout the risk assessment process for hazard identification, release assessment, exposure assessment and consequence assessment. As the quality of risk assessments depends to a large extent on the availability and quality of input data, there is a close relationship between MO&SS and risk assessment. In order to improve the quality of risk assessments, MO&SS should be designed according to minimum quality standards. Second, recent scientific developments on state-of-the-art design and analysis of surveys need to be translated into field applications and legislation. Finally, knowledge about the risk assessment process among MO&SS planners and managers should be promoted in order to assure high-quality data.     

The use of meta-analysis in food contact materials risk assessment

Abstract

As materials intended to be brought into contact with food, food contact materials (FCMs) – including plastics, paper or inks – can transfer their constituents to food under normal or foreseeable use, including direct or indirect food contact. The safety of FCMs in the EU is evaluated by the European Food Safety Authority (EFSA) using risk assessment rules. Results of independent, health-based chemical risk assessments are crucial for the decision-making process to authorize the use of substances in FCMs. However, the risk assessment approach used in the EU has several shortcomings that need to be improved in order to ensure consumer health protection from exposure arising from FCMs. This article presents the use of meta-analysis as a useful tool in chronic risk assessment for substances migrating from FCMs. Meta-analysis can be used for the review and summary of research of FCMs safety in order to provide a more accurate assessment of the impact of exposure with increased statistical power, thus providing more reliable data for risk assessment. The article explains a common methodology of conducting a meta-analysis based on meta-analysis of the dose-effect relationship of cadmium for benchmark dose evaluations performed by EFSA.     

The Concept of Data Utility in Health Risk Assessment: A Multi-Disciplinary Perspective

Human and ecological health risk assessments and the decisions that stem from them require the acquisition and analysis of data. In agencies that are responsible for health risk decision-making, data (and/or opinions/judgments) are obtained from sources such as scientific literature, analytical and process measurements, expert elicitation, inspection findings, and public and private research institutions. Although the particulars of conducting health risk assessments of given disciplines may be dramatically different, a common concern is the subjective nature of judging data utility. Often risk assessors are limited to available data that may not be completely appropriate to address the question being asked. Data utility refers to the ability of available data to support a risk-based decision for a particular risk assessment. This article familiarizes the audience with the concept of data utility and is intended to raise the awareness of data collectors (e.g., researchers), risk assessors, and risk managers to data utility issues in health risk assessments so data collection and use will be improved. In order to emphasize the cross-cutting nature of data utility, the discussion has not been organized into a classical partitioning of risk assessment concerns as being either human health- or ecological health-oriented, as per the U.S. Environmental Protection Agency's Superfund Program.     

Harmonization: Developing Consistent Guidelines for Applying Mode of Action and Dosimetry Information to Cancer and Noncancer Risk Assessment

The 1983 book, Risk Assessment in the Federal Government: Managing the Process, recommended developing consistent inference guidelines for cancer risk assessment. Over the last 15 years, extensive guidance have been provided for hazard assessment for cancer and other endpoints. However, as noted in several recent reports, much less progress has occurred in developing consistent guidelines for quantitative dose response assessment methodologies. This paper proposes an approach for dose response assessment guided by consideration of mode of action (pharmacodynamics) and tissue dosimetry (pharmacokinetics). As articulated here, this systematic process involves eight steps in which available information is integrated, leading first to quantitative analyses of dose response behaviors in the test species followed by quantitative analyses of relevant human exposures. The process should be equally appropriate for both cancer and noncancer endpoints. The eight steps describe the necessary procedures for incorporating mechanistic data and provide multiple options based upon the mode of action by which the chemical causes the toxicity. Given the range of issues involved in developing such a procedure, we have simply sketched the process, focusing on major approaches for using toxicological data and on major options; many details remain to be filled in. However, consistent with the revised carcinogen risk assessment guidance (USEPA, 1996c), we propose a process that would ultimately utilize biologically based or chemical specific pharmacokinetic and pharmacodynamic models as the backbone of these analyses. In the nearer term, these approaches will be combined with analysis of data using more empirical models including options intended for use in the absence of detailed information. A major emphasis in developing any harmonized process is distinguishing policy decisions from those decisions that are affected by the quality and quantity of toxicological data. Identification of data limitations also identifies areas where further study should reduce uncertainty in the final risk evaluations. A flexible dose response assessment procedure is needed to insure that sound toxicological study results are appropriately used to influence risk management decision-making and to encourage the conduct of toxicological studies oriented toward application for dose response assessments.     

Automated assessment reveals that the extinction risk of reptiles is widely underestimated across space and phylogeny

The Red List of Threatened Species, published by the International Union for Conservation of Nature (IUCN), is a crucial tool for conservation decision-making. However, despite substantial effort, numerous species remain unassessed or have insufficient data available to be assigned a Red List extinction risk category. Moreover, the Red Listing process is subject to various sources of uncertainty and bias. The development of robust automated assessment methods could serve as an efficient and highly useful tool to accelerate the assessment process and offer provisional assessments. Here, we aimed to (1) present a machine learning–based automated extinction risk assessment method that can be used on less known species; (2) offer provisional assessments for all reptiles—the only major tetrapod group without a comprehensive Red List assessment; and (3) evaluate potential effects of human decision biases on the outcome of assessments. We use the method presented here to assess 4,369 reptile species that are currently unassessed or classified as Data Deficient by the IUCN. The models used in our predictions were 90% accurate in classifying species as threatened/nonthreatened, and 84% accurate in predicting specific extinction risk categories. Unassessed and Data Deficient reptiles were considerably more likely to be threatened than assessed species, adding to mounting evidence that these species warrant more conservation attention. The overall proportion of threatened species greatly increased when we included our provisional assessments. Assessor identities strongly affected prediction outcomes, suggesting that assessor effects need to be carefully considered in extinction risk assessments. Regions and taxa we identified as likely to be more threatened should be given increased attention in new assessments and conservation planning. Lastly, the method we present here can be easily implemented to help bridge the assessment gap for other less known taxa.

The Red List of Threatened Species, published by the IUCN, is a crucial tool for conservation decision making, but is subject to various sources of uncertainty and bias. Modelling the threat status of all global reptiles identifies increased threat to many groups of reptiles across many regions of the world, beyond those currently recognized; moreover, it highlights the effects of the IUCN assessment procedure on eventual threat categories.     

Beyond protocols: improving the reliability of expert-based risk analysis underpinning invasive species policies

Risk assessment tools for listing invasive alien species need to incorporate all available evidence and expertise. Beyond the wealth of protocols developed to date, we argue that the current way of performing risk analysis has several shortcomings. In particular, lack of data on ecological impacts, transparency and repeatability of assessments as well as the incorporation of uncertainty should all be explicitly considered. We recommend improved quality control of risk assessments through formalized peer review with clear feedback between assessors and reviewers. Alternatively, a consensus building process can be applied to better capture opinions of different experts, thereby maximizing the evidential basis. Elaborating on manageability of invasive species is further needed to fully answer all risk analysis requirements. Tackling the issue of invasive species urges better handling of the acquired information on risk and the exploration of improved methods for decision making on biodiversity management. This is crucial for efficient conservation resource allocation and uptake by stakeholders and the public.     

Genotoxicity risk assessment: a proposed classification strategy

Recent advances in genetic toxicity (mutagenicity) testing methods and in approaches to performing risk assessment are prompting a renewed effort to harmonize genotoxicity risk assessment across the world. The US Environmental Protection Agency (EPA) first published Guidelines for Mutagenicity Risk Assessment in 1986 that focused mainly on transmissible germ cell genetic risk. Somatic cell genetic risk has also been a risk consideration, usually in support of carcinogenicity assessments. EPA and other international regulatory bodies have published mutagenicity testing requirements for agents (pesticides, pharmaceuticals, etc.) to generate data for use in genotoxicity risk assessments. The scheme that follows provides a proposed harmonization approach in which genotoxicity assessments are fully developed within the risk assessment paradigm used by EPA, and sets out a process that integrates newer thinking in testing battery design with the risk assessment process. A classification strategy for agents based on inherent genotoxicity, dose-responses observed in the data, and an exposure analysis is proposed. The classification leads to an initial level of concern for genotoxic risk to humans. A total risk characterization is performed using all relevant toxicity data and a comprehensive exposure evaluation in association with the genotoxicity data. The result of this characterization is ultimately used to generate a final level of concern for genotoxic risk to humans. The final level of concern and characterized genotoxicity risk assessment are communicated to decision makers for possible regulatory action(s) and to the public.     

Genotoxicity risk assessment: a proposed classification strategy

Recent advances in genetic toxicity (mutagenicity) testing methods and in approaches to performing risk assessment are prompting a renewed effort to harmonize genotoxicity risk assessment across the world. The US Environmental Protection Agency (EPA) first published Guidelines for Mutagenicity Risk Assessment in 1986 that focused mainly on transmissible germ cell genetic risk. Somatic cell genetic risk has also been a risk consideration, usually in support of carcinogenicity assessments. EPA and other international regulatory bodies have published mutagenicity testing requirements for agents (pesticides, pharmaceuticals, etc.) to generate data for use in genotoxicity risk assessments. The scheme that follows provides a proposed harmonization approach in which genotoxicity assessments are fully developed within the risk assessment paradigm used by EPA, and sets out a process that integrates newer thinking in testing battery design with the risk assessment process. A classification strategy for agents based on inherent genotoxicity, dose-responses observed in the data, and an exposure analysis is proposed. The classification leads to an initial level of concern for genotoxic risk to humans. A total risk characterization is performed using all relevant toxicity data and a comprehensive exposure evaluation in association with the genotoxicity data. The result of this characterization is ultimately used to generate a final level of concern for genotoxic risk to humans. The final level of concern and characterized genotoxicity risk assessment are communicated to decision makers for possible regulatory action(s) and to the public.     

Recommendations for the design of laboratory studies on non-target arthropods for risk assessment of genetically engineered plants

This paper provides recommendations on experimental design for early-tier laboratory studies used in risk assessments to evaluate potential adverse impacts of arthropod-resistant genetically engineered (GE) plants on non-target arthropods (NTAs). While we rely heavily on the currently used proteins from Bacillus thuringiensis (Bt) in this discussion, the concepts apply to other arthropod-active proteins. A risk may exist if the newly acquired trait of the GE plant has adverse effects on NTAs when they are exposed to the arthropod-active protein. Typically, the risk assessment follows a tiered approach that starts with laboratory studies under worst-case exposure conditions; such studies have a high ability to detect adverse effects on non-target species. Clear guidance on how such data are produced in laboratory studies assists the product developers and risk assessors. The studies should be reproducible and test clearly defined risk hypotheses. These properties contribute to the robustness of, and confidence in, environmental risk assessments for GE plants. Data from NTA studies, collected during the analysis phase of an environmental risk assessment, are critical to the outcome of the assessment and ultimately the decision taken by regulatory authorities on the release of a GE plant. Confidence in the results of early-tier laboratory studies is a precondition for the acceptance of data across regulatory jurisdictions and should encourage agencies to share useful information and thus avoid redundant testing.     

The Intersection of Independent Lies: Increasing Realism in Ecological Risk Assessment

In 1966, Levins presented a philosophical discussion on making inference about populations using clusters of models. In this article we provide an overview of model inference in ecological risk assessment, discuss the benefits and trade-offs of increasing model realism, show the similarities and differences between Levins' model clusters and those used in ecological risk assessment, and present how risk assessment models can incorporate Levins' ideas of truth through independent lies. Two aspects of Levins' philosophy are directly relevant to risk assessment. First, confidence in our interpretation of risk is increased when multiple risk assessments yield similar qualitative results. Second, model clusters should be evaluated to determine if they maximize precision, generality, or realism or a mix of the three. In the later case, the evaluation of each model will differ depending on whether it is more general, precise, or realistic relative to the other models used. We conclude that risk assessments can be strengthened using Levins' idea, but that Levins' caution that model outcome should not be mistaken for truth is still applicable.     

Quality-by-Design II: Application of Quantitative Risk Analysis to the Formulation of Ciprofloxacin Tablets

Qualitative risk assessment methods are often used as the first step to determining design space boundaries; however, quantitative assessments of risk with respect to the design space, i.e., calculating the probability of failure for a given severity, are needed to fully characterize design space boundaries. Quantitative risk assessment methods in design and operational spaces are a significant aid to evaluating proposed design space boundaries. The goal of this paper is to demonstrate a relatively simple strategy for design space definition using a simplified Bayesian Monte Carlo simulation. This paper builds on a previous paper that used failure mode and effects analysis (FMEA) qualitative risk assessment and Plackett-Burman design of experiments to identity the critical quality attributes. The results show that the sequential use of qualitative and quantitative risk assessments can focus the design of experiments on a reduced set of critical material and process parameters that determine a robust design space under conditions of limited laboratory experimentation. This approach provides a strategy by which the degree of risk associated with each known parameter can be calculated and allocates resources in a manner that manages risk to an acceptable level.     

Chemical Mixtures: An Unsolvable Riddle?

It is difficult to overstate the complexity of assessing risks from chemical mixtures. For every valid reason to assess risks from mixtures, there appears an equally valid question as to whether it is possible to do so in a scientifically rigorous and relevant manner. Because so few data exist for mixtures, current mixture assessment methods must rely on untested assumptions and simplifications. That the accuracy of risk estimates improve with the number of chemicals assessed together as mixtures is a valid assumption only if assessment methods for mixtures are better than those based on individual chemicals. On the other hand, arbitrarily truncating a mixture assessment to make it manageable may lead to irrelevant risk estimates. Ideally, mixture assessments should be as broad as necessary to improve accuracy and reduce uncertainty over assessments that only use toxicity data for single chemicals. Further broadening the scope may be ill advised because of the tendency to increase rather than decrease uncertainty. Risk assessment methods that seek to be comprehensive at the expense of increased uncertainty can hardly be viewed as improvements. It would be prudent to verify that uncertainty can be reduced before burdening the risk assessment process with more complexity.     

Bioavailability of Soil-Borne Chemicals: Method Development and Validation

Chemicals present in contaminated soils generally exhibit altered bioavailability compared to other vehicles used in studies of chemical toxicity. Methods used to assess the bioavailability of soil-borne chemicals have generally been modified versions of methods that are widely used in biomedical research. Oral and dermal bioavailability of semivolatile organic chemicals and metals in soil has been assessed by a variety of in vivo and in vitro methods. Due to variations in metabolism and excretion of different chemicals, approaches to measuring bioavailability must be selected with an understanding of disposition of the chemical being studied. Standard methods need to be modified due to constraints associated with doses relevant to environmental concentrations, the need to reflect weathering behavior in soils over time, and the need to generate data applicable to human health risk assessments. Estimates of relative bioavailability for chemicals in soil can be used directly to modify exposure estimates. Application of bioavailability data in a site-specific risk assessment requires regulatory acceptance of the data. Acceptance of the data will generally be dependent on either the use of a validated test method or a careful scientific review of the test method employed. A process for validating newly developed alternative toxicity methods for routine use developed by the Interagency Coordinating Committee on the Validation of Alternative Methods provides relevant guidance for assessing in vitro methods, but method validation should not be the only litmus test for inclusion of bioavailability data in risk assessments.     

Genetic variation in <Emphasis Type="Italic">Delonix s.l.</Emphasis> (Leguminosae) in Madagascar revealed by AFLPs: fragmentation,conservation status and taxonomy

The distribution of genetic diversity has potential to inform conservation efforts but is rarely incorporated when conservation status is assigned to a species. These data can be beneficial to the conservation assessment process by providing information on subpopulations, gene flow and effective population sizes, thus achieving more successful assessments. In order to obtain a better understanding of the patterns of genetic variation and their relationship to conservation in the fragmented flora of Madagascar, this study assessed genetic diversity among and within Delonix s.l. (Leguminosae) using AFLP markers. The genetic diversity of eight species of Delonix s.l. (covering 79 sample sites and 254 individuals) showed a range of values (25–61% for polymorphic loci, and 0.076–0.192 Shannon’s Index). Results from an analysis of molecular variance (AMOVA) suggest that a majority of the genetic variance is attributed to variation within species (87%), which is also supported by a principle coordinate analysis of genetic distances between sites. The results were used to compare the genetic difference between species of different threat status and show that even closely related species with the same IUCN threat status differ in their genetic structure, probably arising from differences in life history traits, pollen and seed dispersal, and fragmentation. Species that are recently affected by habitat destruction and fragmentation are likely to be at high potential risk of genetic erosion contributing to their ongoing decline. Thus, genetic variation should be taken into consideration in conservation assessments, whenever possible, to provide accurate and targeted conservation recommendations in order to achieve more successful conservation outcomes.     

Current risk assessment approaches for environmental and food and feed safety assessment

Foundational activities at the international level underlie current risk and safety assessment approaches for genetically engineered/modified organisms (GEOs/GMOs). Early risk assessment considerations beginning with the OECD ‘Blue Book’ established risk/safety assessment as the characterization of the organism and its environmental release; establishment and persistence in the environment; and human and ecological effects, analyzed in principle through existing methods. Important in this context was recognition that GEOs/GMOs as a class did not represent new risks relative to products of traditional plant breeding and that any incremental risk would need to be established on a stepwise case-by-case comparative basis with existing crops and derived-foods as the baseline. Accordingly, concepts of familiarity and substantial equivalence were advanced by OECD and WHO as ways to establish a risk analysis baseline for determining whether and to what extent risk/safety assessment was needed. Regulatory implementations of this paradigm have skewed to increasingly complex portfolios of studies rather than adhering to analysis which is formulated to fit the risk/safety questions relevant to a given case. Plants produced through genome editing technology will benefit from risk analysis that implements sound problem formulation to guide the need for and nature of risk/safety assessments.

     

Cancer risk from chronic exposures to chemicals and radiation: a comparison of the toxicological reference value with the radiation detriment

This article aims at comparing reference methods for the assessment of cancer risk from exposure to genotoxic carcinogen chemical substances and to ionizing radiation. For chemicals, cancer potency is expressed as a toxicological reference value (TRV) based on the most sensitive type of cancer generally observed in animal experiments of oral or inhalation exposure. A dose–response curve is established by modelling experimental data adjusted to apply to human exposure. This leads to a point of departure from which the TRV is derived as the slope of a linear extrapolation to zero dose. Human lifetime cancer risk can then be assessed as the product of dose by TRV and it is generally considered to be tolerable in a 10^–6–10^–4 range for the public in a normal situation. Radiation exposure is assessed as an effective dose corresponding to a weighted average of energy deposition in body organs. Cancer risk models were derived from the epidemiological follow-up of atomic bombing survivors. Considering a linear-no-threshold dose-risk relationship and average baseline risks, lifetime nominal risk coefficients were established for 13 types of cancers. Those are adjusted according to the severity of each cancer type and combined into an overall indicator denominated radiation detriment. Exposure to radiation is subject to dose limits proscribing unacceptable health detriment. The differences between chemical and radiological cancer risk assessments are discussed and concern data sources, extrapolation to low doses, definition of dose, considered health effects and level of conservatism. These differences should not be an insuperable impediment to the comparison of TRVs with radiation risk, thus opportunities exist to bring closer the two types of risk assessment.

     

Functional Assessments Used by Occupational Therapists with Older Adults at Risk of Activity and Participation Limitations: A Systematic Review

Introduction

The use of functional assessments to evaluate patient change is complicated by a lack of consensus as to which assessment is most suitable for use with older adults. Objective: To identify and appraise the properties of assessments used to evaluate functional abilities in older adults.

Methods

A systematic review of randomised controlled trials of occupational therapy interventions was conducted up to 2012 to identify assessments used to measure function. Two authors screened and extracted data independently. A second search then identified papers investigating measurement properties of each assessment. Studies from the second search were included if: i) published in English, ii) the assessment was not modified from its original published form, iii) study aim was to evaluate the quality of the tool, iv) and was original research. Translated versions of assessments were excluded. Measurement quality was rated using the COSMIN checklist and Terwee criteria.

Results

Twenty-eight assessments were identified from the systematic search of occupational therapy interventions provided to older adults. Assessments were of varied measurement quality and many had been adapted (although still evaluated as though the original tool had been administered) potentially altering the conclusions drawn about measurement quality. Synthesis of best evidence established 15 functional assessments have not been tested in an older adult population.

Conclusions

The Functional Autonomy Measurement System (SMAF) appears to be a promising assessment for use with older adults. Only two tools (the SMAF and the Assessment of Motor and Process Skills (AMPS)) were deemed to be responsive to change when applied to older adults. Health professionals should use functional assessments that have been validated with their population and in their setting. There are reliable and valid assessments to capture the functional performance of older adults in community and hospital settings, although further refinement of these assessments may be necessary.     

Review of risk assessment systems of IAS in Europe and introducing the German–Austrian Black List Information System (GABLIS)

We give a mini-review of existing European risk assessment procedures and present a newly developed and tested risk assessment tool for invasive alien species (IAS) in Germany and Austria, the “German–Austrian Black List Information System” (GABLIS). Based on the analysis of existing European national risk assessment systems, we analyse and discuss: the assessment criteria used; which impacts of IAS (biodiversity, economy) have been considered; for which taxonomic groups has the assessment been designed and tested; how many and which list categories have been used; and, the status of the assessment, i.e. legally binding or advisory. We found that the application of risk assessment systems in Europe started belatedly, however recently a considerable number of assessment systems have been developed and tested. These systems encompass a wide range of purposes and approaches, and so far, no common standard on the aspects mentioned above has been emerged.GABLIS has been developed as a trans-national and taxonomically universal risk assessment system, which takes into account solely the detrimental effects of alien species on biodiversity. We describe which kinds of impacts are considered and how the thresholds have been scaled. We present the structure of the list categories, and we discuss the necessary underlying data for assessment, the assessment criteria and their scaling, and the assessment procedure. Five basic and six complementary criteria are used to assess the alien species’ impact. GABLIS includes three main list categories (White List, Grey List, and Black List).We discuss the practicability of GABLIS by presenting the assessment results of a model taxon (fish), and by presenting the assessment protocol for a vascular plant species. We discuss the necessary data quality for assessments, and the factors which account for differences in the assessments between both countries. We also report on experiences gained in assessments (e.g., average time necessary for assessments). The lessons learnt are discussed in the national and European political context of IAS management.Finally, we explore the strengths and caveats of this approach in the context of national policy on IAS in Germany and Austria and the ongoing European political initiatives. GABLIS is intended to serve as a comprehensive, flexible, but robust risk assessment tool for Central Europe. Being a trans-national risk assessment tool, GABLIS also tests principles, which might contribute valuable insights for a future overall strategy against IAS in Europe.     

The Anna Karenina Principle Applied to Ecological Risk Assessments of Multiple Stressors

Successful ecological risk assessments are all alike; every unsuccessful ecological risk assessment fails in its own way. Tolstoy posited a similar analogy in his novel Anna Karenina: “Happy families are all alike; every unhappy family is unhappy in its own way.” By that, Tolstoy meant that for a marriage to be happy, it had to succeed in several key aspects. Failure on even one of these aspects, and the marriage is doomed. In this paper, I argue that the Anna Karenina principle also applies to ecological risk assessments involving multiple stressors. In particular, I argue that multiple stressors assessments and environmental decision making will not have a happy marriage unless the following can be achieved: (1) there must be societal and political buy-in to the assessment and decision-making process; (2) the assessment must have the latitude to consider a wide range of stressors and potential risk management options; (3) there must be a commitment to following a rigorous focusing of the assessment and to expending resources for model development and data collection; and (4) an adaptive management strategy must be adopted wherein risk management actions are undertaken, system response intensively observed and assessed, and revised management actions taken as appropriate. Failure to meet any of the above criteria for success will doom a multiple stressors assessment and prevent its use in effective decision-making.     

Evaluating Human and Ecological Impacts of a Product Life Cycle: The Complementary Roles of Life-Cycle Assessment and Risk Assessment

Life-cycle assessment (LCA) is a tool for evaluating various health and environmental impacts throughout a product's life. When used as a screening tool, LCA can potentially identify the processes and materials most likely to pose a threat to human health and the environment, and to determine where a risk assessment is warranted. The European Union has issued a ban on lead-based solder from use in electronic equipment beginning in July 2006. In response, the Lead-Free Solder Partnership, involving the U.S. Environmental Protection Agency, several electronics manufacturers, and the University of Tennessee afforded a vehicle for conducting a thorough LCA of leaded and lead-free solders used in the electronics industry. Sixteen impact categories were evaluated in the LCA, including human toxicity.

A primary conclusion of the assessment for human and aquatic toxicity, across the entire life cycle of tin-lead solder, was the potential for impacts derived from the landfilling of lead. These results, based on broad assumptions about exposure, suggest that a more detailed risk assessment of the landfilling process would assist in better understanding the potential for health and environmental risks. We believe LCA data can be used to identify the need for focused risk assessments, allowing the two tools to effectively complement one another. Use of both methods could assist in understanding the effectiveness of the European ban on lead solder and its potential to improve public health.