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.
|Chair(s): Steve Ackerlund firstname.lastname@example.org
Sponsored by Applied Risk Management Specialty Group
M4-H.1 3:30 pm Mutagenic impurities and Human Pharmaceuticals: A discussion of ICH M7 and negligible risk . CRAGIN DW*, GALLOWAY SM, HOLLICK ND; Merck & Co. and Peking University email@example.com
Abstract: The process of manufacturing drugs involves the use of reactive chemicals, reagents, solvents, catalysts, and other processing aids. In addition to the importance of the safety and efficacy of the active ingredient in a drug product, ensuring that drugs have safe levels of impurities is equally important. To support this, the International Conference on Harmonisation issued guidance entitled: “Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk” (ICH M7). This guideline provides “Threshold of Toxicological Concern” (TTC) levels as default limits and also discusses compound specific approaches and adjustments for shorter, “less than lifetime”, exposures. When compared to typical daily life exposure to mutagenic substances such as formaldehyde, it’s evident that the TTC levels provide a large margin of safety for patients. We will show how most compounds associated with drug syntheses are not in the classes of potent carcinogens on which the default TTC was based, illustrating the conservative nature of the TTC and the rationale for not applying the guidance retrospectively to marketed compounds. Also, while safe doses of carcinogens that are mutagens have traditionally been calculated assuming a linear dose response, we will discuss the substantial evidence for non-linear dose responses or tumors that are not relevant to humans, and the increasing evidence for “thresholds” in dose responses for DNA reactive mutagens. Examples will be provided including discussion of some individual chemicals addressed in ICH M7(R1). This assessment will show how companies assess and control potential mutagenic impurities and quantitatively illustrate the level of protection provided to patients by the ICH M7 limits.
M4-H.4 4:30 pm Nontraditional Irrigation Water: Understanding Farmersâ€™ Needs and Risk Perceptions. Goldstein RER*, Suri MR, Dery JL, Brassill NA, Pee DG, Goeringer LP, Rock CM; University of Maryland firstname.lastname@example.org
Abstract: As climate variability continues, it is prudent to explore alternative water sources available to irrigated agriculture. To facilitate adoption, understanding of both farmers’ needs and perceptions of risk is critical. CONSERVE (COordinating Nontraditional Sustainable watER Use in Variable climatEs): A Center of Excellence at the Nexus of Sustainable Water Reuse, Food, and Health is a USDA-funded project spanning the U.S. Mid-Atlantic and Southwest focused on conserving groundwater through nontraditional irrigation water quality analysis, assessing concerns, developing on-farm treatment technologies, and analyzing legal, economic and social constraints to adoption. Nontraditional water (recycled, brackish, agricultural runoff, livestock wastewater and process waters) as a viable option for agricultural irrigation largely depends on grower buy-in and consumer preferences. However, to date, no studies exist on farmers’ knowledge, willingness to use, or real or perceived risks of nontraditional water. A needs assessment survey was distributed to farmers (n=375) in 2017 both online and at stakeholder meetings. Questions covered current irrigation water sources, familiarity with nontraditional water, and concerns. Survey data was collected with Qualtrics and analyzed with STATA. The majority of growers were concerned with water availability (75%), consider nontraditional water in agriculture at least moderately important (81%), and would use nontraditional water to supplement current water sources (83%) if available. Water quality and health risks were among the top concerns related to nontraditional water with factsheets, workshops, and approval from trusted sources ranking highest as methods to address real or perceived risks of nontraditional water. Results indicate farmers value water planning and are open to using nontraditional water for irrigation. Education and outreach will be important to communicate benefits and manage risks related to nontraditional water.
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