The need to develop new tools and increased capacity to test chemicals and pharmaceuticals for potential adverse impact on human health and the environment is an active area of development. A series of NRC reports in 2007 and 2009 recognized and recommended that effective implementation of new technologies in risk assessment requires interdisciplinary and inter-sector dialogue, as well as a consistent and coherent strategy for validating and then integrating new technologies into the existing risk assessment framework.
Framework for Intelligent Non-Animal Alternative Methods for Safety Assessment Subcommittee
Framework for Intelligent for Non-Animal Methods for Safety Assessment Subcommittee
The response to challenges for a “paradigm shift” toward using newer alternative non-animal methods for safety assessment has resulted in an explosion of independent initiatives by numerous organizations, and a lack of broad agreement on objectives for determining the credibility of non-animal testing.
Scientific confidence in the final recommendations of independent groups working on alternative non-animal methods would be strengthened by a consistent set of criteria against which to assess the reliability of a new method. Such criteria will likely need to be context sensitive, i.e., specific to the intended regulatory decision under consideration (e.g., prioritization, classification, hazard prediction). These criteria for approaches to new method verification would be instrumental in determining whether a method is suitable for its intended application (“fit-for-purpose”) in similar regulatory decisions across agencies and geographies.
The HESI Subcommittee, formed in the fall of 2014, has the following objectives:
- Create a tripartite forum to discuss non-animal methods / approaches independent of any regulatory, policy, or participant restrictions imposed by specific agencies or organizations.
- Determine criteria to be used in assessing fitness-for-purpose of methods and approaches for decision-making, i.e., what are the minimum requirements or criteria for demonstrating that a method or approach can be used for risk assessment, regulation, etc.?
- Provide guidance and general criteria (not specifics) for each type of major decision (e.g., prioritization / screening, read-across, hazard assessment, risk assessment).
- Ensure peer engagement to assess the acceptability of the group’s proposals.
- Develop a white paper/publication that reflects the consensus of the group on the points above.
This HESI program is not intended as a mechanism to develop assays, develop criteria for specific assays or methods, or certify or provide a “seal of approval” to specific assays.
It is envisioned that the resulting criteria developed by this tripartite group would be used by independent organizations to guide development of organization-specific guidelines and new non-animal methods for safety assessment. The benefits of developing these criteria via the tripartite HESI approach include the following:
Establishes an umbrella framework of criteria which are consistent, transparent, and generally accepted, and that can be used by different institutions for different decision-making purposes.
Promotes harmonization and uniformity across and among organizations.
Click here to access a June 2014 HESI Annual Meeting presentation about this project proposal.
Prof. Alan Boobis, OBE, Ph.D.
Imperial College London
Doug Wolf, D.V.M., Ph.D., FIATP, ATS