Principles for Conduct of Pest Risk Analyses: Report of an Expert Workshop

The North American Free Trade Agreement (NAFTA) and the General Agreement on Tariffs and Trade (GATT) have focused attention on risk assessment of potential insect, weed, and animal pests and diseases of livestock. These risks have traditionally been addressed through quarantine protocols ranging from limits on the geographical areas from which a product may originate, postharvest disinfestation procedures like fumigation, and inspections at points of export and import, to outright bans. To ensure that plant and animal protection measures are not used as nontariff trade barriers, GATT and NAFTA require pest risk analysis (PRA) to support quarantine decisions. The increased emphasis on PRA has spurred multiple efforts at the national and international level to design frameworks for the conduct of these analyses. As approaches to pest risk analysis proliferate, and the importance of the analyses grows, concerns have arisen about the scientific and technical conduct of pest risk analysis. In January of 1997, the Harvard Center for Risk Analysis (HCRA) held an invitation-only workshop in Washington, D.C. to bring experts in risk analysis and pest characterization together to develop general principles for pest risk analysis. Workshop participants examined current frameworks for PRA, discussed strengths and weaknesses of the approaches, and formulated principles, based on years of experience with risk analysis in other setting and knowledge of the issues specific to analysis of pests. The principles developed highlight the both the similarities of pest risk analysis to other forms of risk analysis, and its unique attributes.     

Quantifying Potential Human Health Impacts of Animal Antibiotic Use: Enrofloxacin and Macrolides in Chickens

Use of similar or identical antibiotics in both human and veterinary medicine has come under increasing scrutiny by regulators concerned that bacteria resistant to animal antibiotics will infect people and resist treatment with similar human antibiotics, leading to excess illnesses and deaths. Scientists, regulators, and interest groups in the United States and Europe have urged bans on nontherapeutic and some therapeutic uses of animal antibiotics to protect human health. Many regulators and public health experts have also expressed dissatisfaction with the perceived limitations of quantitative risk assessment and have proposed alternative qualitative and judgmental approaches ranging from "attributable fraction" estimates to risk management recommendations based on the precautionary principle or on expert judgments about the importance of classes of compounds in human medicine. This article presents a more traditional quantitative risk assessment of the likely human health impacts of continuing versus withdrawing use of fluoroquinolones and macrolides in production of broiler chickens in the United States. An analytic framework is developed and applied to available data. It indicates that withdrawing animal antibiotics can cause far more human illness-days than it would prevent: the estimated human BENEFIT:RISK health ratio for human health impacts of continued animal antibiotic use exceeds 1,000:1 in many cases. This conclusion is driven by a hypothesized causal sequence in which withdrawing animal antibiotic use increases illnesses rates in animals, microbial loads in servings from the affected animals, and hence human health risks. This potentially important aspect of human health risk assessment for animal antibiotics has not previously been quantified.     

Risk Assessment for Invasive Species

Although estimates vary, there is a broad agreement that invasive species impose major costs on the U.S. economy, as well as posing risks to nonmarket environmental goods and services and to public health. The domestic effort to manage risks associated with invasive species is coordinated by the National Invasive Species Council (NISC), which is charged with developing a science-based process to evaluate risks associated with the introduction and spread of invasive species. Various international agreements have also elevated invasive species issues onto the international policy agenda. The World Trade Organization (WTO) Sanitary and Phytosanitary (SPS) Agreement establishes rights and obligations to adhere to the discipline of scientific risk assessment to ensure that SPS measures are applied only to the extent required to protect human, animal, and plant health, and do not constitute arbitrary or unjustifiable technical barriers to trade. Currently, however, the field of risk assessment for invasive species is in its infancy. Therefore, there is a pressing need to formulate scientifically sound methods and approaches in this emerging field, while acknowledging that the demand for situation-specific empirical evidence is likely to persistently outstrip supply. To begin addressing this need, the Society for Risk Analysis Ecological Risk Assessment Specialty Group and the Ecological Society of America Theoretical Ecology Section convened a joint workshop to provide independent scientific input into the formulation of methods and processes for risk assessment of invasive species to ensure that the analytic processes used domestically and internationally will be firmly rooted in sound scientific principles.     

Some Limitations of Qualitative Risk Rating Systems

Qualitative systems for rating animal antimicrobial risks using ordered categorical labels such as “high,”“medium,” and “low” can potentially simplify risk assessment input requirements used to inform risk management decisions. But do they improve decisions? This article compares the results of qualitative and quantitative risk assessment systems and establishes some theoretical limitations on the extent to which they are compatible. In general, qualitative risk rating systems satisfying conditions found in real‐world rating systems and guidance documents and proposed as reasonable make two types of errors: (1) Reversed rankings, i.e., assigning higher qualitative risk ratings to situations that have lower quantitative risks; and (2) Uninformative ratings, e.g., frequently assigning the most severe qualitative risk label (such as “high”) to situations with arbitrarily small quantitative risks and assigning the same ratings to risks that differ by many orders of magnitude. Therefore, despite their appealing consensus‐building properties, flexibility, and appearance of thoughtful process in input requirements, qualitative rating systems as currently proposed often do not provide sufficient information to discriminate accurately between quantitatively small and quantitatively large risks. The value of information (VOI) that they provide for improving risk management decisions can be zero if most risks are small but a few are large, since qualitative ratings may then be unable to confidently distinguish the large risks from the small. These limitations suggest that it is important to continue to develop and apply practical quantitative risk assessment methods, since qualitative ones are often unreliable.     

Risk Management in a Polio-Free World

Inherent in the decision to launch the Global Polio Eradication Initiative in 1988 was the expectation for many people that immunization against poliomyelitis would eventually simply stop, as had been the case with smallpox following its eradication in 1977. However, the strategies for managing the risks associated with a "polio-free" world must be continuously refined to reflect new developments, particularly in our understanding of the live polioviruses in the oral poliovirus vaccine (OPV) and in the international approach to managing potential biohazards. The most important of these developments has been the confirmation in 2000 that vaccine-derived polioviruses (VDPVs) can circulate and cause polio outbreaks, making the use of OPV after interruption of wild poliovirus transmission incompatible with a polio-free world. A comprehensive strategy has been developed to minimize the risks associated with eventual OPV cessation, centered on appropriate long-term biocontainment of poliovirus stocks (whether for vaccine production, diagnosis, or research), the controlled reintroduction of any live poliovirus vaccine (i.e., from an OPV stockpile), and appropriate use of the inactivated poliovirus vaccine (IPV). Although some aspects of this risk management strategy are still debated, there is wide agreement that no strategy would entirely eliminate the potential risks to a polio-free world. The current strategy for risk management in a polio-free world will continue to evolve with better characterization of these risks and the development of more effective approaches both to reduce those risks and to limit their consequences should they occur.     

The Weakest Link: Demonstrating the Inconsistency of "Appropriate Levels of Protection" in Australia-Salmon

In Australia-Salmon, the WTO Appellate Body found Australia to be in violation of the WTO SPS Agreement based on the inconsistency of the "appropriate level of protection" underlying various SPS measures. Article 5.5 of the SPS Agreement prohibits arbitrary or unjustifiable distinctions in "appropriate levels of protection" if such distinctions result in discrimination or a disguised restriction on international trade. In Australia-Salmon, Canada challenged Australia's import ban on salmon. Australia permitted the entry of other fish products that were known to host some of the same diseases cited by Australia in justifying its salmon import ban. The distinction in the "appropriate levels of protection" between Australia's regulation of salmon and its treatment of these other fish products was found to be "arbitrary or unjustified" and to have "resulted in a restriction on international trade."Australia-Salmon was the first WTO decision to find an Article 5.5 violation. Canada successfully made a "weakest link" argument to undercut Australia's regulatory justification. The decision rests on the relationship between the risk purportedly justifying the salmon import ban and the risk seemingly ignored in Australia's treatment of other fish products-the regulatory "situations" compared concerned the identical pathogens with the identical potential consequences. As such, Australia-Salmon may be an example of a category of regulatory "chains" that are peculiarly exposed to Article 5.5 challenge. In responding to the Appellate Body's ruling, Australia reduced its limits on salmon and imposed new restrictions on the other fish products. The outcome suggests that a challenge of one SPS measure under Article 5.5 may lead to the imposition of new restrictions on other imported products-an unexpected result for the free trade regime.     

One Agency's Use of Risk Assessment and Risk Communication1

Few organizations have the courage to evaluate their own use of risk assessment (identifying hazards and estimating their probability and magnitude) and risk communication (interacting with internal and external stakeholder groups about risks). The USDA Animal and Plant Health Inspection Service (APHIS) wants to enhance its overall risk analysis process for managing a wide range of risks to animals, plants, and human health. We gathered survey data for a baseline of APHIS professionals’ understanding and use of risk assessment and risk communication. APHIS professionals spend a surprisingly large share of their time communicating about risks. They perceive that risk estimates influence decisions, but that risk estimates should have more influence. Respondents reported little opposition to APHIS risk management decisions, and little use of channels such as USDA Extension Service for disseminating risk messages. Substantial variance across responses is explained mostly by differences in the roles of the 11 work units (now 10) within the agency. Location also contributes to the variance. Demographic variables seem less important.     

A Risk Analysis Model in Concurrent Engineering Product Development

Concurrent engineering has been widely accepted as a viable strategy for companies to reduce time to market and achieve overall cost savings. This article analyzes various risks and challenges in product development under the concurrent engineering environment. A three‐dimensional early warning approach for product development risk management is proposed by integrating graphical evaluation and review technique (GERT) and failure modes and effects analysis (FMEA). Simulation models are created to solve our proposed concurrent engineering product development risk management model. Solutions lead to identification of key risk controlling points. This article demonstrates the value of our approach to risk analysis as a means to monitor various risks typical in the manufacturing sector. This article has three main contributions. First, we establish a conceptual framework to classify various risks in concurrent engineering (CE) product development (PD). Second, we propose use of existing quantitative approaches for PD risk analysis purposes: GERT, FMEA, and product database management (PDM). Based on quantitative tools, we create our approach for risk management of CE PD and discuss solutions of the models. Third, we demonstrate the value of applying our approach using data from a typical Chinese motor company.     

Efficacy Foundations for Risk Communication: How People Think About Reducing the Risks of Climate Change

Believing action to reduce the risks of climate change is both possible (self‐efficacy) and effective (response efficacy) is essential to motivate and sustain risk mitigation efforts, according to current risk communication theory. Although the public recognizes the dangers of climate change, and is deluged with lists of possible mitigative actions, little is known about public efficacy beliefs in the context of climate change. Prior efficacy studies rely on conflicting constructs and measures of efficacy, and links between efficacy and risk management actions are muddled. As a result, much remains to learn about how laypersons think about the ease and effectiveness of potential mitigative actions. To bring clarity and inform risk communication and management efforts, we investigate how people think about efficacy in the context of climate change risk management by analyzing unprompted and prompted beliefs from two national surveys (N = 405, N = 1,820). In general, respondents distinguish little between effective and ineffective climate strategies. While many respondents appreciate that reducing fossil fuel use is an effective risk mitigation strategy, overall assessments reflect persistent misconceptions about climate change causes, and uncertainties about the effectiveness of risk mitigation strategies. Our findings suggest targeting climate change risk communication and management strategies to (1) address gaps in people's existing mental models of climate action, (2) leverage existing public understanding of both potentially effective mitigation strategies and the collective action dilemma at the heart of climate change action, and (3) take into account ideologically driven reactions to behavior change and government action framed as climate action.     

Public participation in life cycle assessment and risk assessment: a shared need.

Life cycle assessment (LCA) and risk assessment are operationally different but share the common purpose of supporting decisions about reducing threats to human welfare. Both analysis methods also involve a complex mixture of science and value judgments reflecting epistemological as well as moral and esthetic values. The inability of risk assessment and LCA to be "value free" has been a source of considerable controversy in both communities. Recognition of the contingent and social nature of human interpretation of the risks and environmental impacts created by public and private decisions has led to an increased appreciation of the importance of involving interested and affected parties in risk characterization. Comparison of the value-based nature of LCA and risk assessment demonstrates the need for participation in LCA. Although the need for participation by affected parties in decision-making processes is gaining acceptance, there is little agreement as to how participation should be structured. Risk assessment and LCA have a shared need for research examining the design and analysis of participation processes appropriate to a given decision context. A proposed framework recommends participation strategies designed to enhance the effectiveness of policy-driven analyses such as risk assessment and LCA based on the level of trust that interested and affected parties have for other policy participants.     

Development of Economic Consequence Methodology for Process Risk Analysis

A comprehensive methodology for economic consequence analysis with appropriate models for risk analysis of process systems is proposed. This methodology uses loss functions to relate process deviations in a given scenario to economic losses. It consists of four steps: definition of a scenario, identification of losses, quantification of losses, and integration of losses. In this methodology, the process deviations that contribute to a given accident scenario are identified and mapped to assess potential consequences. Losses are assessed with an appropriate loss function (revised Taguchi, modified inverted normal) for each type of loss. The total loss is quantified by integrating different loss functions. The proposed methodology has been examined on two industrial case studies. Implementation of this new economic consequence methodology in quantitative risk assessment will provide better understanding and quantification of risk. This will improve design, decision making, and risk management strategies.     

Quantitative Estimates of Risk for Noncancer Endpoints

While quantitative estimates of risk have been a standard practice in cancer risk assessment for many years, no similar practice is evident in noncancer risk assessment. We use two recent examples involving methylmercury and arsenic to illustrate the negative impact of this discrepancy on risk communication and cost-benefit analysis. We argue for a more balanced treatment of cancer and noncancer risks and suggest an approach for reaching this goal.     

Internationalization of Emerging Economy SMEs: A Tripod Approach

Research suggests that internationalizing SMEs in the West enjoy far greater institutional support. There is, however, little understanding of the internationalization processes of emerging economies' SMEs (EESMEs) and yet they are notable contenders in international trade. Accordingly, this research draws from an integrated strategy tripod framework to develop new perspectives accounting for how Iranian-based EESMEs internationalize and compete in international markets. A comprehensive analysis of Iranian EESMEs' survey data revealed that, other than their owner's managerial perceptions of their industry, firm, and institutional constraints, international market knowledge (IMK) significantly moderated their internationalization strategies. Such understanding advances research on firm internationalization by pinpointing the central role of IMK in forming internationalization strategies by EESMEs in hard-to-reach contexts, which has implications for academic research and policy-making, leading to needed reform based on theory and practice.     

Risk Management Solutions for Climate Change–Induced Disasters

In honor of the 40th anniversary of Risk Analysis, this article suggests ways of linking risk assessment and risk perception in developing risk management strategies that have a good chance of being implemented, focusing on the problem of reducing losses from natural hazards in the face of climate change. Following a checklist for developing an implementable risk management strategy, Section 2 highlights the impact that exponential growth of CO₂ emissions is likely to have on future disaster losses as assessed by climate and social scientists. Section 3 then discusses how people perceive the risks of low-probability adverse events and the cognitive biases that lead them to underprepare for future losses. Based on this empirical evidence, Section 4 proposes a risk management strategy for reducing future losses using the principles of choice architecture to communicate the likelihood and consequences of disasters, coupled with economic incentives and well-enforced regulations.     

Assessing Potential Human Health Hazards and Benefits from Subtherapeutic Antibiotics in the United States: Tetracyclines as a Case Study

Many scientists, activists, regulators, and politicians have expressed urgent concern that using antibiotics in food animals selects for resistant strains of bacteria that harm human health and bring nearer a “postantibiotic era” of multidrug resistant “super‐bugs.” Proposed political solutions, such as the Preservation of Antibiotics for Medical Treatment Act (PAMTA), would ban entire classes of subtherapeutic antibiotics (STAs) now used for disease prevention and growth promotion in food animals. The proposed bans are not driven by formal quantitative risk assessment (QRA), but by a perceived need for immediate action to prevent potential catastrophe. Similar fears led to STA phase‐outs in Europe a decade ago. However, QRA and empirical data indicate that continued use of STAs in the United States has not harmed human health, and bans in Europe have not helped human health. The fears motivating PAMTA contrast with QRA estimates of vanishingly small risks. As a case study, examining specific tetracycline uses and resistance patterns suggests that there is no significant human health hazard from continued use of tetracycline in food animals. Simple hypothetical calculations suggest an unobservably small risk (between 0 and 1.75E‐11 excess lifetime risk of a tetracycline‐resistant infection), based on the long history of tetracycline use in the United States without resistance‐related treatment failures. QRAs for other STA uses in food animals also find that human health risks are vanishingly small. Whether such QRA calculations will guide risk management policy for animal antibiotics in the United States remains to be seen.     

What's Wrong with Risk Matrices?

Risk matrices—tables mapping "frequency" and "severity" ratings to corresponding risk priority levels—are popular in applications as diverse as terrorism risk analysis, highway construction project management, office building risk analysis, climate change risk management, and enterprise risk management (ERM). National and international standards (e.g., Military Standard 882C and AS/NZS 4360:1999) have stimulated adoption of risk matrices by many organizations and risk consultants. However, little research rigorously validates their performance in actually improving risk management decisions. This article examines some mathematical properties of risk matrices and shows that they have the following limitations. (a) Poor Resolution . Typical risk matrices can correctly and unambiguously compare only a small fraction (e.g., less than 10%) of randomly selected pairs of hazards. They can assign identical ratings to quantitatively very different risks ("range compression"). (b) Errors . Risk matrices can mistakenly assign higher qualitative ratings to quantitatively smaller risks. For risks with negatively correlated frequencies and severities, they can be "worse than useless," leading to worse-than-random decisions. (c) Suboptimal Resource Allocation . Effective allocation of resources to risk-reducing countermeasures cannot be based on the categories provided by risk matrices. (d) Ambiguous Inputs and Outputs . Categorizations of severity cannot be made objectively for uncertain consequences. Inputs to risk matrices (e.g., frequency and severity categorizations) and resulting outputs (i.e., risk ratings) require subjective interpretation, and different users may obtain opposite ratings of the same quantitative risks. These limitations suggest that risk matrices should be used with caution, and only with careful explanations of embedded judgments.     

企业IT项目风险评估与规避策略研究

结合企业竞争性战略思想构建了一个企业IT项目风险评估与规避模型,建立了企业IT项目风险评估的指标体系,在对湖北省128家企业信息化项目与风险现状调查研究的基础上对风险因素进行了分类、测度和评估,得出了战略与风险的内在关系,并根据风险评估结果分析了企业战略执行的效果。最后,对高风险的企业IT项目提出了一套风险规避策略并进行应用。结果表明,计划与控制风险对各种企业IT项目执行的竞争性战略均有显著影响,采取不同战略的企业,影响其IT项目开发的风险各不相同,选择风险规避的策略与时机也存在差异。     

Limiting Exposure to Collateral Liability Associated With ISO 14001 EMS Audits

The purpose of this article is to provide suggestions on how to limit the collateral liability associated with ISO 14001 environmental management system (EMS) auditing activities. Due to the detailed, invasive nature of EMS audits, companies performing such activities may expose themselves to collateral risks. Collateral risk is liability not directly associated with ISO 14001 activities, but borne through the unrelated process of EMS audit activities. Examples of collateral risks include issues of non-compliance, unintended discovery of evidence in civil tort claims and exposure to regulatory sanctions. Therefore, well-defined management of EMS audits represents an important aspect of limiting risk. This article identifies several strategies for managing and reducing these legal risks. These strategies include the rigorous management of compliance audits, concisely defining audit scopes, training auditors and auditees, understanding and using audit privileges as appropriate, exploring the use of self-declaration (for ISO 14001 conformance purposes), and using reliable document control methods. While completely eliminating liability represents a laudable but challenging goal, these methods should reduce collateral exposure to corporate and personal liability.     

Rethinking Risk Assessment for Public Utility Safety Regulation

To aid in their safety oversight of large‐scale, potentially dangerous energy and water infrastructure and transportation systems, public utility regulatory agencies increasingly seek to use formal risk assessment models. Yet some of the approaches to risk assessment used by utilities and their regulators may be less useful for this purpose than is supposed. These approaches often do not reflect the current state of the art in risk assessment strategy and methodology. This essay explores why utilities and regulatory agencies might embrace risk assessment techniques that do not sufficiently assess organizational and managerial factors as drivers of risk, nor that adequately represent important uncertainties surrounding risk calculations. Further, it describes why, in the special legal, political, and administrative world of the typical public utility regulator, strategies to identify and mitigate formally specified risks might actually diverge from the regulatory promotion of “safety.” Some improvements are suggested that can be made in risk assessment approaches to support more fully the safety oversight objectives of public regulatory agencies, with examples from “high‐reliability organizations” (HROs) that have successfully merged the management of safety with the management of risk. Finally, given the limitations of their current risk assessments and the lessons from HROs, four specific assurances are suggested that regulatory agencies should seek for themselves and the public as objectives in their safety oversight of public utilities.     

Managing “forced” technology transfer in emerging markets: The case of China

This paper explores how foreign multinational corporations (MNCs) manage risks associated with “forced” technology transfer (“FTT”) policies in emerging markets. Although MNCs are increasingly exposed to appropriability risks from these policies, how they respond is relatively understudied in international business (IB) research. We explore this topic based upon a survey and interviews with Western MNCs doing business in China, as well as a discussion about the recent US-China trade war. We find that, as traditional IB theory would predict, internally-oriented strategies (e.g., internalization, maintenance of informal intellectual property (IP), and control of technological centrality and sophistication) are often used to respond to FTT policies; however, the risks from such policies can sometimes be more efficiently managed by externally-oriented strategies (e.g., non-market activities and reliance on formal IP). We discuss how the co-evolution of MNCs' risk management strategies alongside changing value chains, IP institutions, and conditions determining the leverage of FTT policies appear to contribute to this phenomenon. We argue that IB research should more prominently recognize the role of externally-oriented strategies, not only internally-oriented ones, in managing the complex IP-related institutional challenges present in emerging markets today.