| Literature DB >> 21170118 |
Abstract
In order to facilitate stakeholder discussions on how to regulate nanotechnology, the opensource program multicriteria mapping (MCM) was used to structure 26 interviews with stakeholders in the USA. MCM offers a systematic part quantitative, part qualitative approach to clarify why some regulatory options (bans, moratoriums, voluntary measures, etc.) were deemed to be acceptable/unacceptable by various stakeholders and which criteria stakeholders used to evaluate the different regulatory options. Adopting an incremental approach and implementing a new regulatory framework was evaluated as the best options whereas a complete ban and no additional regulation of nanotechnology were found to be the least favorable. Criteria applied differed substantially among stakeholders and included social, ethical, regulatory, environmental, and health issues. Opinions on future regulation seem far less polarized than expected and it seems that stakeholders would welcome a combination of voluntary measures, an incremental approach and forming of a new regulatory framework. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (doi:10.1007/s11051-010-0006-3) contains supplementary material, which is available to authorized users.Entities:
Year: 2010 PMID: 21170118 PMCID: PMC2988199 DOI: 10.1007/s11051-010-0006-3
Source DB: PubMed Journal: J Nanopart Res ISSN: 1388-0764 Impact factor: 2.253
Fig. 1Distribution of stakeholders into overall perspectives
Predefined policy options and additional options identified
| 1. Ban nanotechnology: ban R&D and commercialization of nanotechnology and nanomaterials |
| 2. Ban some nanotechnologies and materials: ban some branches of nanotechnologies and materials based on hazard assessment |
| 3. Moratorium on R&D and commercialization: decreeing a moratorium on nanotechnologies R&D and/or commercialization for targeted engineered nanomaterials until safety has been tested |
| 4. Moratorium of commercialization: moratorium of commercialization of all nanomaterials until safety has been tested |
| 5. Relying on voluntary measures: relying on industry voluntary measures—The Government will set up a forum for exchange of information on the properties of nanomaterials and health and safety issues based on voluntary industry reporting and testing |
| 6. Forming and implementing a new regulatory framework: launching a comprehensive, in-depth regulatory process specific to nanotechnologies that aims at developing an entirely new legislative framework that tries to take all the widely different nanomaterials and applications into consideration |
| 7. The incremental approach: launching an incremental process using existing legislative structures—e.g., dangerous substances legislation, classification and labeling, cosmetic legislation, etc.—to the maximum, revisiting them, and, when appropriate only, amending them. This includes issuing recommendations, commissioning studies, promoting risk assessment throughout the life cycle of a nanotechnology; encouraging actions of existing institutions; supporting the setting up an observatory of nanotechnologies; initiating a minimalist, appropriate and proportionate regulatory intervention setting up a framework within which stakeholders can participate in shaping the course of nanotechnologies |
| 8. No additional regulation needed: the current regulatory framework is considered adequate to protect humans and the environment from risks of nanotechnology and nanomaterials and there is no need for adaptation or additional regulation |
| 1. Forming a new regulatory framework plus moratorium on commercialization |
| 2. Ban some specific nanomaterials based on risk assessment |
| 3. Proactive precautionary incremental approacha |
| 4. Environmental management systems on nanotechnologyb |
| 5. Voluntary program plus incremental approach |
| 6. Reactive incremental approachc |
| 7. Implement a voluntary program and rely on current legislation at present and development of a new regulatory framework down the road |
| 8. Voluntary environmental program plus incremental approach plus new regulatory framework |
| 9. Combination of a moratorium of commercialization plus forming and implementing a new regulatory framework |
| 10. Combination of a moratorium of commercialization plus forming and implementing a new regulatory framework based on non-vertebrate testingd |
| 11. Incremental approach plus ban some branches of nanotechnologies and materials based on hazard assessment |
| 12. Aggressive incremental approache |
| 13. Ban some nanotechnologies and materials or moratorium R&D and commercialization combined with either forming and implement-ting a new regulatory framework or an incremental approach |
| 14. Voluntary measures plus incremental approach |
| 15. Preventive incremental approachf |
| 16. Proportional incremental approachg |
| 17. Free marked based on insurance policies |
| 18. Insurance and reinsurance based policies |
| 19. Liability based policies |
| 20. Incremental approach combined with publicly available industry-generated environmental, health and safety informationh |
| 21. Evidentiary proportional approach combined with a non-step wise incremental approachi |
| 22. Voluntary measures and increased agency discretionary authorities while the current regulatory system is being revisedj |
a–jSee supplementary information for further definition of this option
Fig. 2Final ranking scheme generated for an academic (a) and the trade association representative (b)
Fig. 3Ranking of the various policy options across their overall perspectives (a–i) and the relative magnitudes of criteria weightings assigned to different issues under a selected perspective (I–IX). Rank mean. Rank extreme
Fig. 4Distribution of criteria classified according to clusters