Predicting Future Human and Environmental Health Challenges: The Health and Environmental Sciences Institute's Scientific Mapping Exercise

Abstract

To predict important strategic issues in product safety during the next 10 years, the Health and Environmental Sciences Institute (HESI) of the International Life Sciences Institute initiated a mapping exercise to evaluate which issues are likely to be of societal, scientific, and regulatory importance to regulatory authorities, the HESI membership, and the scientific community at large. Scientists representing government, academia, and industry participated in the exercise. Societal issues identified include sensitive populations, alternative therapies, public education on the precautionary principle, obesity, and aging world populations. Scientific issues identified include cancer testing, children's health, mixtures and co-exposures, sensitive populations, idiosyncratic reactions, “omics” or bioinformatics, and environmental toxicology. Regulatory issues identified include national and regional legislation on chemical safety, exposure inputs, new technologies, transitioning new science into regulations and guidelines, conservative default factors, data quality, and sensitive populations. Because some issues were identified as important in all three areas (e.g. sensitive populations), a comprehensive approach to assessment and management is needed to ensure consideration of societal, scientific, and regulatory implications. The resulting HESI Combined Challenges Map is not intended to offer a universal description of challenges in safety assessment, nor is it intended to address, advocate, or manage the prioritized issues. Rather, the map focuses on and predicts issues likely to be central to the strategic agendas of individual companies and regulatory authorities in the developed world. Many of these issues will become increasingly important in the future in rapidly developing economies, such as India and China. The scientific mapping exercise has particular value to the toxicology community because it represents the contributions of key scientists from around the world from government, academia, and industry.

Keywords:

• HESI
• product safety
• regulatory challenges
• scientific challenges
• scientific mapping
• societal challenges
• toxicology

ACKNOWLEDGMENTS

The views expressed in this article are those of the authors and do not necessarily reflect the views of participants in the April 6–7, 2004, HESI Scientific Mapping meeting (see Appendix 1).

The authors acknowledge the contributions of Dr. Michelle Embry (HESI) and Dr. Ronald Hines (Medical College of Wisconsin) to this paper. Professor Alan R. Boobis (Imperial College London) is recognized for his leadership in conducting the HESI peer-review process before its submission for publication. Appreciation is extended to all participants in the April 2004 HESI mapping session (listed in Appendix 1) and to Mr. Tim Fallon (TSI Consulting Partners, Inc.) for facilitating the session.

Notes

¹In the context of this paper, the term ‘chemicals’ includes agrichemicals, pharmaceuticals, industrial chemicals, consumer products, and physical agents.

² It is not the purpose of this paper to evaluate the procedures, value, or effectiveness of ICCVAM and ECVAM.

³Gray literature typically includes documents not published in scientific peer-reviewed journals, such as reports, fact sheets, newsletters, theses, dissertations, working papers, and the like.

*Indicates affiliation in April 2004. Affiliation has since changed. The views expressed in this article are those of the authors and do not necessarily reflect the views of the participants in the April 6–7, 2004, HESI Scientific Mapping meeting.