Society For Risk Analysis Annual Meeting 2017

Session Schedule & Abstracts

* Disclaimer: All presentations represent the views of the authors, and not the organizations that support their research. Please apply the standard disclaimer that any opinions, findings, and conclusions or recommendations in abstracts, posters, and presentations at the meeting are those of the authors and do not necessarily reflect the views of any other organization or agency. Meeting attendees and authors should be aware that this disclaimer is intended to apply to all abstracts contained in this document. Authors who wish to emphasize this disclaimer should do so in their presentation or poster. In an effort to make the abstracts as concise as possible and easy for meeting participants to read, the abstracts have been formatted such that they exclude references to papers, affiliations, and/or funding sources. Authors who wish to provide attendees with this information should do so in their presentation or poster.

Common abbreviations

Exposure, Hazard and Risk Assessment: Putting Exposure Back in the Process

Room: Salon K   8:30 am–10:00 am

Chair(s): Patricia Nance, Debra Kaden

Sponsored by Exposure Assessment Specialty Group

W1-I.1  8:30 am  Hazard vs. Risk: Blurring of the Lines. Kaden DA*; Ramboll Environ

Abstract: Risk assessment involves the estimation of the probability, impact, and other attributes of an adverse effect, through multiple components including hazard identification, dose-response, and exposure assessment. This approach evolved in the 1970’s, with the desire to replace bright-line approaches with quantitative risk assessments. Since then, there have been many improvements on basic risk assessment methods, including significant advances in exposure science. Advances in risk assessment methodology also incorporate problem formulation, mechanistic data, and mode-of-action considerations. Methods for performing systematic reviews and evidence integration allow for comprehensive, neutral reviews of the state of the science. Such guidance for better risk assessment conduct and management have improved the process and better descriptions of uncertainties in the risk calculations have informed our understanding of how confident to be in the results. In recent years, however, either due to lack of data or a desire to rapidly assess risks, there has been a trend towards using hazard identification as a surrogate for risk. Although this may appear attractive due to the simplification of the process (which either downplays or removes exposure from the equation), the result may lead to unfounded public fear and, sometimes, regulatory decisions being made without a true understanding of relative risks. In order to make informed decisions in risk management, all steps of the risk assessment process are necessary. Exposure pathways must be understood, and exposure magnitude estimated. The dose-response must also be understood. The talks in this session will present different examples and perspectives on the use of hazard identification as a surrogate for risk, and the pros and cons of the approach.

W1-I.2  8:50 am  Chemical hazard assessment tools for identification of chemicals of concern. Whittaker MH*; ToxServices LLC

Abstract: Chemical hazard assessment (CHA) is a systematic process of assessing and classifying hazards across a spectrum of physical, health, and/or environmental endpoints. CHA is used by industry, government and NGOs to support product design and development, materials procurement, and as part of alternatives assessment to meet regulatory requirements. Eliminating or substituting a chemical of concern in a product and throughout a supply chain can be an expensive proposition. When faced with a chemical restriction, the least proactive position a company can take is to eliminate the restricted chemical of concern and replace it with a structurally similar chemical that is currently unrestricted. This approach can be risky because it is possible that the substitute will have the same (or worse) hazard characteristics as the original chemical of concern. In order to conduct a chemical hazard assessment, it is critical to understand the Globally Harmonized System of Classification and Labelling of Chemicals (“GHS”). GHS is a system for harmonizing hazard classification criteria and chemical hazard communication elements worldwide, and includes consideration of mixtures toxicity. In addition to GHS, there are publicly accessible, transparent, non-regulatory, stand-alone chemical hazard assessment schemes that build on GHS. Best known systems in the United States include U.S. EPA’s Design for the Environment (DfE) Alternatives Assessment Criteria for Hazard Evaluation, Clean Production Action’s GreenScreen® for Safer Chemicals, and the Cradle to Cradle Products Innovation Institute’s Material Health hazard assessment protocol. Examples of these CHA methods including case report examples showing how these tools by industry will be presented, including discussion of how and when exposure considerations can be incorporated into the assessment process.

W1-I.2  9:10 am  Global trends in risk assessment in pesticide regulation. Kelly ID*, Ryan NM; Bayer Crop Science

Abstract: For several decades the Environmental Protection Agency has been a key authority in the development and implementation of risk assessment and risk characterization as it relates to pesticides. The Agency has been a proponent of assessments that are risk rather than hazard based due to the clear anomalies that a hazard based system can introduce. The Delaney Clause was one such example. First introduced in 1958, and covering the use of food additives found to cause cancer in animals or humans, its application in the registration of crop protection chemicals was clearly limiting the introduction of new safe chemistries. The Food Quality Protection Act was passed in 1996 and put the assessment of human risk on a strong scientific basis. In recent years, however the European Union has become more active in pesticide regulatory processes. Cut-off criteria for “CMR” chemicals (carcinogen, mutagen or reproductive toxicant) have been introduced and criteria are also under discussion for endocrine disrupters. The anomalies and inconsistences this divergence causes in relation to global food production and the development of innovative technologies will be discussed. The case for an improved definition of the role of exposure in informing toxicological testing and risk characterization will be presented.

W1-I.4  9:30 am  Risk, Hazard, Precaution, and Adaptive Policy Learning. Wiener JB*; Duke University

Abstract: The Precautionary Principle (PP) espouses regulation of uncertain risks, sometimes based on hazard alone, without consideration of exposure, risk, or policy impacts. (1) Priority selection. The PP offers little guidance on which risks or hazards deserve priority. Because all risks pose uncertainty, the application of the PP may be overbroad or arbitrary. Some hazards with low exposure may be selected while other hazards with high exposure may not. A common claim is that Europe has become more precautionary than the US, but the reality has been selective application of precaution to particular risks on both sides of the Atlantic. (2) Perverse outcomes. Invoking the PP may impede innovation and induce risk-risk tradeoffs. We need attention not only to exposure to the hazard, but also to exposure to the policy. The solution is to broaden beyond the target hazard, ensuring full portfolio impact assessment toward reducing overall risk. (3) Permanence vs. learning. Uncertainty warrants not permanent precaution but rather investment in learning. Precaution should be “provisional” or “adaptive” to ensure review and updating over time. Retrospective review is needed to assess policy performance, not just to reduce costs but to compare policy designs and to improve the accuracy of prospective impact assessments. International regulatory cooperation should not simply harmonize standards, but should learn from observed policy variation. Crisis events can be opportunities for learning if institutions are designed in advance to “prepare to learn.” The strongest case for true precaution is not uncertainty, but rather the obstacles to learning from extreme catastrophic risks. Learning can be pursued through a menu of instrument choices for adaptive regulation. Improved versions of precaution should go beyond hazard to assess risks (including exposure), benefits, costs, and risk tradeoffs, and to foster adaptive learning over time.

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