# Presentation: 277065

## Nanotechnology Environment, Health, and Safety 

- EPA Perspectives and Activities
- September 11, 2007
**Jim Willis, Director**
**Chemical Control Division**
**Office of Pollution Prevention and Toxics**

## Nanotechnology White Paper

- Developed by EPA’s Science Policy Council (SPC)
- Provide information to EPA managers
- Not intended as regulatory document
- Published Feb 15, 2007

## White Paper: Contents

_**Table of Contents**_
- Section 1:  Introduction
- Section 2:  Environmental Benefits of Nanotechnology
- Section 3:  Risk Assessment of Nanomaterials
- Section 4:  Responsible Development
- Section 5:  EPA’s Research Needs
- Section 6:  Recommendations
- Appendices:
- Appendix A: Glossary of Nanotechnology Terms
- Appendix B: Principles of Environmental Stewardship Behavior
- Appendix C: EPA’s Nanotechnology Research Framework
- Appendix D: EPA STAR Grants for Nanotechnology
- Appendix E: List of External Peer Reviewers

## EPA Nanotechnology Research

**Extramural Grants**
- Through 2007, 86 grants awarded for approx. $30 million
- Approximately 50/50 applications and implications research
- Information available online at _**www.epa.gov/ncer/nano**_** **
**In-house Research**
- Large amount of relevant research on toxicity of ultrafine particulate matter
- 2008 budget proposal has funding for in-house nano-research
**Agency research strategy**

## Possible Research Directions

**2007 and 2008**
- Environmental fate, transport, transformation, and exposure
- Monitoring and detection methods
- 	Resulting data would be used to inform and develop effects and exposure assessment methods, and identify important points of releases for potential management.
**2009 – 2012**
- Health and ecological effects, understanding toxicity of the altered materials (as identified in 2007-2008). To be informed and refined by case studies, to be initiated in 2007, to elicit information on how to address high-exposure-potential nanomaterials.
- By 2011-2012, develop systematic and integrated approaches to assess, manage, and communicate any identified risks associated with nanomaterials in the environment.

## Pollution Prevention Conferences

**P2 Conferences**
- ORD/OPPT will jointly hold a conference on  Pollution Prevention through Nanotechnology on 25-26 September, 2007 in Washington DC
- ORD will hold a conference on the clean development of NMs in 2008 (TBD)
- Use of nanotechnology or nanomaterials in current manufacturing process to prevent pollution
- Nanomaterial products that
- provide a greener alternative to current products
- improve energy efficiency

## Approaches for Nanoscale Materials under TSCA (1)

- Many nanoscale materials (NMs) are chemical substances as defined by the Toxic Substances Control Act (TSCA)
- NMs not on the TSCA Inventory are new chemicals and a Pre-Manufacture Notice (PMN) is required before commencement of manufacture – over 20 PMNs have been received in the past 2 years.
- There is presently no similar requirement for NMs that are existing chemicals, i.e. already on the TSCA inventory
- Program needs include:
- A mechanism to collaboratively generate data needed to provide a sound scientific foundation for assessments
- An appropriate interim approach to obtain better informed decision-making on  new chemicals and realize oversight of “existing” chemical NMs
- An appropriate degree of industry stewardship in the manufacture and use of new and existing chemical NMs

## Approaches for Nanoscale Materials under TSCA (2)

- NMs Program under TSCA that includes
- Both regulatory and stewardship components
- Encourages responsible development of NMs
- Regulatory:
- New Chemicals Program
- Issue targeted SNURs for specific NMs or categories where there is evidence of
- Risk concerns
- Significant exposure/release potential
- Information gathering
- Section 8(a) – report use and exposure data
- Section 8(d) – report health and safety studies

## Nanoscale Materials Stewardship Program 

- OPPT developing a Stewardship Program for Nanoscale Materials
- Step 1 –Collaborative Program Design
- Step 2 – Implement NM Stewardship Program
- Step 3 – Evaluation of Stewardship Program
- Program anticipated to have 2 “tiers” – a basic program and an in-depth program

## Nanoscale Materials Stewardship Program

- Initial public meeting in June 2005
- Federal Advisory Committee (National Pollution Prevention and Toxics Advisory Committee (NPPTAC)) provided an “Overview Document” forwarded to EPA for its review/consideration (Nov, 2005)
- EPA announced a collaborative public process to develop a program in October 2006
- Peer consultation on risk management held in October 2006; peer consultation on materials characterization held on September 6-7, 2007
- Draft concept, inventory guidance, ICR released on July 12, 2007; public meeting held on August 2 in Washington DC.
- Program rollout anticipated late 2007.

## Other EPA Office Activities

- OAR -- reviewing an application under the CAA for registration of a diesel additive that claims to be nanosized cerium oxide.
- OPP -- receiving inquiries about nanoscale materials and is forming a workgroup to consider issues
- OSWER -- held a workshop July 2006 on nanotechnology and waste management practices

## OECD WPMN (1)

- The Chemicals Committee of the Organisation for Economic Co-Operation and Development (OECD) established a Working Party on Manufactured Nanomaterials (WPMN) effective September, 2006
- The objective is to ***promote international co-operation in health and environmental safety related aspects of manufactured nanomaterials, in order to assist in their safe development***
- WPMN-1 met in London, October 26-27, 2006
- WPMN-2 met in Berlin, April 26-28, 2007
- WPMN-3 will meet in Paris, November 28-30, 2007
- The US (EPA) chairs the working party

## OECD WPMN (2)

- The Working Party is working in small steering groups to advance certain specific projects:
- Development of an OECD Research Database (Australia Chairs)
- Environmental Health and Safety Research Strategies on Manufactured Nanomaterials (Germany Chairs)
- Safety Testing of a Representative Set of Manufactured Nanomaterials (US (EPA)/EC Co-Chairs)
- Manufactured Nanomaterials and Test Guidelines (US (EPA)/EC Co-Chairs)
- Co-operation on Voluntary Schemes and Regulatory Programmes (Canada Chairs)
- Co-operation on Risk Assessments (UK Chairs)
- US-led task to develop a project on Exposure Measurements and Exposure Mitigation (US (NIOSH) Chairs)