scholarly journals Quantitative Interpretation of Genetic Toxicity Dose‐Response Data for Risk Assessment and Regulatory Decision‐Making: Current Status and Emerging Priorities

2019 ◽  
Vol 61 (1) ◽  
pp. 66-83 ◽  
Author(s):  
Paul A. White ◽  
Alexandra S. Long ◽  
George E. Johnson
Keyword(s):  
Risk Assessment ◽  
Decision Making ◽  
Dose Response ◽  
Current Status ◽  
Quantitative Interpretation ◽  
Genetic Toxicity ◽  
Regulatory Decision ◽  
Response Data

Framework for Identification and Collection of Data Useful for Risk Assessments of Microbial Foodborne or Waterborne Hazards: A Report from the International Life Sciences Institute Research Foundation Advisory Committee on Data Collection for Microbial Risk Assessment

2007 ◽  
Vol 70 (7) ◽  
pp. 1744-1751 ◽  
Author(s):  
ISABEL WALLS
Keyword(s):  
Risk Assessment ◽  
Decision Making ◽  
Risk Management ◽  
Data Collection ◽  
Dose Response ◽  
Management Decision ◽  
Microbial Risk Assessment ◽  
Microbial Risk ◽  
Response Data ◽  
Management Decision Making

A microbial risk assessment (MRA) can provide the scientific basis for risk management decision making. Much data are needed to complete an MRA, including quantitative data for pathogens in foods. The purpose of this document was to provide information on data needs and data collection approaches for MRAs that will be useful for national governments, particularly in developing countries. A framework was developed, which included the following activities: (i) identify the purpose of data collection—this should include stating the specific question(s) to be addressed; (ii) identify and gather existing data—this should include a determination of whether the data are sufficient to answer questions to be addressed; (iii) develop and implement a data collection strategy; (iv) analyze data and draw conclusions; and (v) use data to answer questions identified at the start of the process. The key data needs identified for an MRA were as follows: (i) burden of foodborne or waterborne disease; (ii) microbial contamination of foods; and (iii) consumption patterns. In addition, dose-response data may be necessary, if existing dose-response data cannot be used to estimate dose response for the population of interest. Data should be collected with a view to its use in risk management decision making. Standard sampling and analysis methods should be used to ensure representative samples are tested, and care should be taken to avoid bias when selecting data sets. A number of barriers to data collection were identified, including a lack of clear understanding of the type of data needed to undertake an MRA, which is addressed in this document.

scholarly journals Quantal Risk Assessment Database: A Database for Exploring Patterns in Quantal Dose-Response Data in Risk Assessment and its Application to Develop Priors for Bayesian Dose-Response Analysis

Risk Analysis ◽  
2018 ◽  
Vol 39 (3) ◽  
pp. 616-629 ◽  
Author(s):  
Matthew W. Wheeler ◽  
Walter W. Piegorsch ◽  
Albert John Bailer
Keyword(s):  
Risk Assessment ◽  
Dose Response ◽  
Response Analysis ◽  
Response Data

scholarly journals Using sparse dose-response data for wildlife risk assessment

2013 ◽  
Vol 10 (1) ◽  
pp. 3-11 ◽  
Author(s):  
Ryan A Hill ◽  
Brian J Pyper ◽  
Gary S Lawrence ◽  
Gary S Mann ◽  
Patrick Allard ◽  
...  
Keyword(s):  
Risk Assessment ◽  
Dose Response ◽  
Response Data

The Extension of Molecular and Computational Information to Risk Assessment and Regulatory Decision Making*

2006 ◽  
pp. 151-180 ◽  
Author(s):  
James Bus ◽  
Richard Canady ◽  
Tracy Collier ◽  
J William Owens ◽  
Syril Pettit ◽  
...  
Keyword(s):  
Risk Assessment ◽  
Decision Making ◽  
Regulatory Decision

scholarly journals Translating Scientific Advances in the AOP Framework to Decision Making for Nanomaterials

Nanomaterials ◽  
2020 ◽  
Vol 10 (6) ◽  
pp. 1229 ◽  
Author(s):  
James D. Ede ◽  
Vladimir Lobaskin ◽  
Ulla Vogel ◽  
Iseult Lynch ◽  
Sabina Halappanavar ◽  
...  
Keyword(s):  
Risk Assessment ◽  
Decision Making ◽  
Working Party ◽  
Integrated Approach ◽  
Advanced Materials ◽  
Current Status ◽  
Adverse Outcome Pathway ◽  
Animal Testing ◽  
Manufactured Nanomaterials ◽  
Wide Range

Much of the current innovation in advanced materials is occurring at the nanoscale, specifically in manufactured nanomaterials (MNs). MNs display unique attributes and behaviors, and may be biologically and physically unique, making them valuable across a wide range of applications. However, as the number, diversity and complexity of MNs coming to market continue to grow, assessing their health and environmental risks with traditional animal testing approaches is too time- and cost-intensive to be practical, and is undesirable for ethical reasons. New approaches are needed that meet current requirements for regulatory risk assessment while reducing reliance on animal testing and enabling safer-by-design product development strategies to be implemented. The adverse outcome pathway (AOP) framework presents a sound model for the advancement of MN decision making. Yet, there are currently gaps in technical and policy aspects of AOPs that hinder the adoption and use for MN risk assessment and regulatory decision making. This review outlines the current status and next steps for the development and use of the AOP framework in decision making regarding the safety of MNs. Opportunities and challenges are identified concerning the advancement and adoption of AOPs as part of an integrated approach to testing and assessing (IATA) MNs, as are specific actions proposed to advance the development, use and acceptance of the AOP framework and associated testing strategies for MN risk assessment and decision making. The intention of this review is to reflect the views of a diversity of stakeholders including experts, researchers, policymakers, regulators, risk assessors and industry representatives on the current status, needs and requirements to facilitate the future use of AOPs in MN risk assessment. It incorporates the views and feedback of experts that participated in two workshops hosted as part of an Organization for Economic Cooperation and Development (OECD) Working Party on Manufactured Nanomaterials (WPMN) project titled, “Advancing AOP Development for Nanomaterial Risk Assessment and Categorization”, as well as input from several EU-funded nanosafety research consortia.

The use of risk assessment in regulatory decision making: Time for a review

1981 ◽  
Vol 1 (3) ◽  
pp. 264-276 ◽  
Author(s):  
John T. Barr ◽  
Donald H. Hughes ◽  
Robert C. Barnard
Keyword(s):  
Risk Assessment ◽  
Decision Making ◽  
Regulatory Decision

Initiating and Managing Risk Assessments within a Risk Analysis Framework: FDA/CFSAN'S Practical Approach

2004 ◽  
Vol 67 (9) ◽  
pp. 2058-2062 ◽  
Author(s):  
ROBERT L. BUCHANAN ◽  
SHERRI DENNIS ◽  
MARIANNE MILIOTIS
Keyword(s):  
Risk Assessment ◽  
Decision Making ◽  
Risk Management ◽  
Risk Analysis ◽  
Risk Assessments ◽  
Analysis Framework ◽  
Regulatory Decision ◽  
Managing Risk ◽  
Risk Managers ◽  
The U.S

Management of risk analysis involves the integration and coordination of activities associated with risk assessment, risk management, and risk communication. Risk analysis is used to guide regulatory decision making, including trade decisions at national and international levels. The U.S. Food and Drug Administration Center for Food Safety and Applied Nutrition (CFSAN) formed a working group to evaluate and improve the quality and consistency of major risk assessments conducted by the Center. Drawing on risk analysis experiences, CFSAN developed a practical framework for initiating and managing risk assessments, including addressing issues related to (i) commissioning a risk assessment, (ii) interactions between risk managers and risk assessors, and (iii) peer review.

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