1. Technology Services – National Institute of Standards and Technology Facilitating Global Markets: NIST Dialogue with Regulators Mary Saunders Chief, Standards Services Division NIST NCSLI 2004 Workshop and Symposium Salt Lake City, Utah

2. Technology Services – National Institute of Standards and Technology Global R&D common science-based consensus standards Consensus Standards early commercialization of technology Regulator Collaboration better data to identify benefits and risks of technology Goal: fully realize the promise of new technologies while minimizing trade barriers and protecting public health and the environment

3. Technology Services – National Institute of Standards and Technology Outline Regulator interests U.S. regulatory philosophy and principles Treatment of risk and uncertainty NIST roles in support of regulation Regulators and nanotechnology Role of global collaboration Conclusion

4. Technology Services – National Institute of Standards and Technology Regulator Interests Reliable measurements and data Technically sound standards to support regulation Demonstrated competence of laboratories providing test and calibration data Proof that global arrangements can support protection of health, safety and the environment as well as trade facilitation

5. Technology Services – National Institute of Standards and Technology U.S. Regulatory Philosophy Executive Order 12866 – Regulatory Planning and Review (September 1993) states that agencies should – Promulgate only such regulations as are required – Assess all costs and benefits of available regulatory alternatives, including not regulating – Select approaches that maximize net benefits wherever possible

6. Technology Services – National Institute of Standards and Technology Regulatory Principles Identify the problem Examine whether existing regulations have created or contributed to the problem Identify and assess available alternatives to direct regulation Consider, to the extent reasonable, the degree and nature of risks posed by substances on activities within its jurisdiction Design regulations in the most cost-effective manner Assess costs and benefits

7. Technology Services – National Institute of Standards and Technology Regulatory Principles, continued Base regulatory decisions on best available scientific, technical, economic and other information Identify and assess alternative forms of regulation. Specifying performance objectives where possible Seek views of appropriate State and local officials where relevant Tailor regulations to impose the least burden on society Draft regulations to be simple and easy to understand

8. Technology Services – National Institute of Standards and Technology Economic Analysis of Federal Regulations Analysis of Benefits and Costs – Baseline – Evaluation of alternatives – Discounting – Treatment of risk and uncertainty – risk assessment, valuing risk levels and changes – Assumptions – International trade effects – Nonmonetized benefits and costs – Distributional effects and equity

9. Technology Services – National Institute of Standards and Technology Treatment of Risk and Uncertainty Risk Assessment: assessment of outcomes associated with regulatory action to address risks to health, safety and the environment – characterizes the probabilities of occurrence of outcomes of interest; and a valuation of the levels and changes in risk experienced by affected populations as a result of regulation Risk Management: policy of whether and how to respond to risks to health, safety and the environment. The appropriate level of protection is a policy choice rather than a scientific one.

10. Technology Services – National Institute of Standards and Technology Risk Assessment Issues Quality and reliability of data, models, assumptions, scientific inferences and other information Uncertainties in cost estimates Conflicting scientific theories to be evaluated Making assumptions - in the absence of adequate valid data, assumptions need to be properly identified False sense of precision - overall risk assessments cannot be more precise that their most uncertain component

11. Technology Services – National Institute of Standards and Technology NIST Roles in Support of Regulation Measurement research – Technical underpinning for standards – In support of regulation Measurement services – Calibrations – Standard reference materials Standards – Participate in development of voluntary standards

12. Technology Services – National Institute of Standards and Technology Examples There are more than 400 references to NIST in the Code of Federal Regulations – Publications – Calibrations/traceability – SRMs – Laboratory accreditation NIST promotes regulator acceptance of test and calibration data from ILAC and other MRA partners to NVLAP NIST provides support to regulators to enable reliance on the CIPM MRA and KCDB

13. Technology Services – National Institute of Standards and Technology Regulators and Nanotechnology Relevant regulatory agencies responsible for assessing and regulating workplace, environmental and health risks: – Environmental Protection Agency – Occupational Safety and Health Administration – National Institute of Occupational Safety and Health – Food and Drug Administration – Department of Agriculture – Consumer Product Safety Commission

14. Technology Services – National Institute of Standards and Technology Regulatory Issues Nomenclature Safety – Pharmacology and toxicology challenges – Are current required studies adequate? – Are new testing models needed? Facility/environmental assessment – Facility design – Introduction of particles into air, water, soil – Transport and transformation

15. Technology Services – National Institute of Standards and Technology Work Already Underway Active efforts are underway to ensure that existing regulatory mechanisms, or appropriately amended ones, provide proper coverage of nanotechnology-based materials Research is in progress – in Federal laboratories, private industry and academia – to determine how nanotechnology-based materials may differ from conventional ones in implications for public health and the environment

16. Technology Services – National Institute of Standards and Technology U.S. Coordination Efforts – National Nanotechnology Initiative Nanoscale Science, Engineering and Technology Subcommittee (NCSET) Interagency Group on health and environmental impacts of nanomaterials – Membership from all relevant regulatory and research agencies – Goals: Serve as communications channel Identify major issues Examine existing regulatory mechanisms Develop a best practices document for working with nanomaterials Work with industry and academia to develop nomenclature for nanomaterials

17. Technology Services – National Institute of Standards and Technology Research Efforts Underway NIH/NIEHS EPA DOE Molecular Foundry and Lawrence Berkeley National Lab NSF FDA DOD NIOSH NIST

18. Technology Services – National Institute of Standards and Technology Conclusions Effective regulation requires sound standards – both measurement and documentary Opportunities exist with new technologies to collaborate at the R&D stage to develop standards and tests that are accepted globally Existing international arrangements provide support for global acceptance