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Abstracts (PDF file, 1.8MB) - Society for Risk Analysis

Abstracts (PDF file, 1.8MB) - Society for Risk Analysis

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SRA 2013 Annual Meeting <strong>Abstracts</strong><br />

T4-F.2 Marchant, GE*; Lindor, RA; Arizona State University;<br />

gary.marchant@asu.edu<br />

Managing Pharmacogenomic <strong>Risk</strong>s Through Litigation<br />

Liability is an important, although often under-appreciated,<br />

mechanism <strong>for</strong> managing the risks of new technologies. Key<br />

actors in the development and application of technologies are<br />

often motivated by potential liability concerns. This is certainly<br />

the case in the medical field, where past experiences such as<br />

bendectin, DES, silicone breast implants, Vioxx, and medical<br />

malpractice have made both product developers and health<br />

care providers very sensitive to, and aware of, liability risks.<br />

The development of personalized medicine, in which<br />

diagnostics and therapeutics are targeted at the<br />

pharmacogenomic pro<strong>file</strong> of the individual patient, will present<br />

new or enhanced liability risks to both the product developers<br />

and providers <strong>for</strong> a number of reasons including: (i) failure to<br />

accurately convey risks of false positives and false negatives;<br />

(ii) inexperience and lack of training/expertise in applying new<br />

technologies; (iii) unrealistic or inflated patient expectations;<br />

(iv) disparities in the conduct of different manufacturers and<br />

providers in designing and applying new, rapidly evolving<br />

technologies; and (v) novel liability claims such as violation of<br />

emerging duties such as a duty to disclose individual<br />

in<strong>for</strong>mation to at risk relatives. This presentation will review<br />

three recent lawsuits that present different theories of liability<br />

relating to pharmacogenomic testing (one relating to cancer<br />

predisposition, one relating to drug metabolism, and one<br />

relating to prenatal testing), and will evaluate both the<br />

potential positive and negative implications of such liability<br />

lawsuits <strong>for</strong> managing the risks of personalized medicine.<br />

T3-F.2 Marks, PD; Law Firm; pmarks@bdlaw.com<br />

Existing Tools <strong>for</strong> Accessing Federal Data<br />

A number of different tools can be used to seek data that<br />

resides with a Federal agency or is created with the use of<br />

Federal funding. Sometimes data can be obtained directly and<br />

in<strong>for</strong>mally as the result of a cooperative dialogue. When data is<br />

not voluntarily made available, other mechanisms may be<br />

pursued. The Freedom of In<strong>for</strong>mation Act is frequently used to<br />

obtain data, and recent developments in the case law clarify<br />

when a requester may turn to the courts to en<strong>for</strong>ce the Act.<br />

Where the data was generated by institutions <strong>for</strong> higher<br />

education, hospitals and other non-profit organizations through<br />

grants or agreements with the Federal government, Office of<br />

Management and Budget Circular A-110 may shed light on the<br />

availability of data. In addition, data disclosure is fundamental<br />

to the In<strong>for</strong>mation Quality Act. This talk will discuss the process<br />

<strong>for</strong> obtaining data and some of the strengths and limitations of<br />

A-110, FOIA, and IQ.<br />

T3-B.1 Martin, LR*; Teuschler, LK; O'Brien, W; U.S.<br />

Environmental Protection Agency; martin.lawrence@epa.gov<br />

Overview of the Environmental Protection Agency (EPA)<br />

Cumulative <strong>Risk</strong> Assessment (CRA) Guidelines Ef<strong>for</strong>t and<br />

Its Scientific Challenges<br />

The EPA Administrator directed EPA to account <strong>for</strong> CRA issues<br />

in planning, scoping and risk analysis and to integrate multiple<br />

sources, effects, pathways, stressors and populations into its<br />

major risk assessments. EPA established a <strong>Risk</strong> Assessment<br />

Forum CRA Technical Panel to develop Guidelines. The<br />

Guidelines will articulate broad underlying principles and<br />

provide a set of descriptive, science-based procedures and<br />

methods specific to CRA <strong>for</strong> use by EPA’s program offices and<br />

regions. Significant scientific challenges remain to be<br />

addressed in the development of the CRA Guidelines. The<br />

introduction of non-chemical stressors and unconventional<br />

initiating factors (such public health outcomes) in a CRA results<br />

in additional complexities <strong>for</strong> all facets of CRA planning,<br />

communication, analysis and uncertainty. This presentation will<br />

address proposed methods <strong>for</strong> addressing these challenges.<br />

Science questions addressed in this presentation will include:<br />

identification and evaluation of nonchemical stressors and<br />

psychosocial factors that influence risks posed by<br />

environmental exposures under EPA’s purview; use of<br />

epidemiology study data and traditional or high throughput<br />

toxicology data to in<strong>for</strong>m health impacts of stressor<br />

combinations; and communication with stakeholders regarding<br />

the CRA scope, analysis plan and results.<br />

T1-B.4 Marty, MA*; Zeise, L; Salmon, AG; Cal/EPA, Office of<br />

Environmental Health Hazard Assessment;<br />

melanie.marty@oehha.ca.gov<br />

IRIS Improvements: Meeting the Needs of Cali<strong>for</strong>nia<br />

The National Research Council’s recommendations to U.S.EPA<br />

to improve the IRIS process included measures to take to<br />

increase clarity of the steps in the risk assessment process used<br />

by EPA <strong>for</strong> chemical specific quantitative risk assessments. The<br />

states, including Cali<strong>for</strong>nia, rely on the IRIS assessments <strong>for</strong><br />

making decisions as to the need <strong>for</strong> controls of pollution<br />

sources <strong>for</strong> various media (air, water, soil, food, wildlife). While<br />

Cali<strong>for</strong>nia is somewhat unique in having resources and<br />

mandates to conduct quantitative risk assessments <strong>for</strong> many<br />

chemicals, we do not have the extent of resources and expertise<br />

as U.S. EPA. Thus, we utilize EPA assessments and look to IRIS<br />

as an important resource. This presentation will focus on the<br />

utility of and potential improvements in changes EPA is making<br />

in establishing guidelines and templates <strong>for</strong> literature search<br />

and screening, evaluation and display of study data, including<br />

evidence tables, integration of the database, and presentation<br />

of dose-response modeling. We will also provide input on areas<br />

where additional discussion of potentially sensitive<br />

subpopulations, human heterogeneity and cumulative impacts<br />

could be improved.<br />

December 8-11, 2013 - Baltimore, MD

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