1. The Possible Adverse Consequences of Preemptive Nanotechnology Regulation John C. Monica, Jr. Porter Wright Morris & Arthur, L.L.P. Washington, D.C. www.nanolawreport.com Regulations for Nanotechnology in Consumer Products Intertech-Pira February 9, 2007

2. REGULATION FROM THE TOP DOWN EPA, FDA, OSHA, CPSC, Standard Setting Bodies, etc. Need for significant progress tempered by patience. Careful analysis of existing science and detailed timeline for what still needs to be done. Existing laws probably sufficient with some modification. Carefully evaluate proposals for new laws. Implement any new regulations in comprehensive and orderly manner. Emphasis on getting things right the first time. Porter Wright Morris & Arthur LLP

3. REGULATION FROM THE TOP DOWN K. Florini, et al., “Nanotechnology: Getting It Right the First Time,” Nanotechnology Law & Business, February/March 2006, www.nanolabweb.com Good Example: Porter Wright Morris & Arthur LLP

4. REGULATION FROM THE BOTTOM UP Local, County, and State Governments Need immediate action (immediately). Comprehensive new laws needed because of unique properties of nanomaterials. Implement new laws now -- come back and fix things as knowledge base grows. Protect public while research and studies are ongoing. Possible moratorium on use of nanomaterials until health effects fully determined. Porter Wright Morris & Arthur LLP

5. Berkeley, California’s Nanomaterials Reporting and Handling Ordinance First in the United States. Implemented out of impatience with federal government. Intent is that other governments will follow. Alleged input from nano-community. Viewed by its proponents as a “minimum” level of necessary regulation. Porter Wright Morris & Arthur LLP

6. Ordinance All facilities that manufacture or use manufactured nanoparticles shall submit a separate written disclosure of the current toxicology, to the extent known, and how the facility will safely handle, monitor, contain, dispose, track inventory, prevent release and mitigate such materials... All manufactured nanoparticles defined as a particle with one axis less than 100 nanometers in length, shall be reported in the disclosure plan. Porter Wright Morris & Arthur LLP

7. Issues 1. Definition of “nanoparticle.” 2. Are toxicology reporting requirements reasonable? 3. Are materials handling requirements reasonable? 4. Should there be a minimum threshold requirement? 5. Why only “manufactured” nanoparticles? 6. Spawn litigation/chill business development? 7. Confidentiality concerns. Porter Wright Morris & Arthur LLP

8. Ordinance : 1. Definition of Nanoparticle. All manufactured nanoparticles defined as a particle with one axis less than 100 nanometers in length. Nat. Nano. Initiative Engineered nanomaterials are those that have been purposefully manufactured or synthesized to have a size with at least one dimension in the range of approximately 1 – 100 nm and that exhibit unique properties determined by this size ASTM A sub-classification of ultrafine particles with lengths in two or three dimensions greater than 0.001 micrometer (1 nanometer) and smaller than about 0.1 micrometer (100 nanometers) and which may or may not exhibit size-related intensive property. Porter Wright Morris & Arthur LLP

9. 2.Are toxicology reporting requirements reasonable?... shall submit a separate written disclosure of the current toxicology, to the extent known... Ordinance : Toxicology of what? Actual particles v. Existing categories? Cousins? NIOSH Nanoparticle Information Library (NIL)? What type(s) of toxicology? Exposure routes, subspecialties ? “To the extent known”... New toxicology research necessary? “to the extent already published” Literature search? ICON database sufficient? WHY? Porter Wright Morris & Arthur LLP Conflicting data? Report all? Helpful?

10. 3.Are materials handling requirements reasonable?... how the facility will safely handle, monitor, contain, dispose, track inventory, prevent release and mitigate such materials... Ordinance : Porter Wright Morris & Arthur LLP How to accomplish if toxicology still undecided? Precautionary principles – differences in approaches. Pharmaceutical model v. Traditional industrial hygiene model. What’s reasonable? Federal guidelines?

11. 4.Should there be a minimum threshold requirement? “Traditional” = 500 pds per year aggregate threshold (ex/ lead and mercury) v. All manufactured nanoparticles (in any amount) Porter Wright Morris & Arthur LLP

12. 5.Why only “manufactured” nanoparticles? Manufactured v. Natural Incidental Engineered Porter Wright Morris & Arthur LLP

13. 6.Spawn litigation/chill business development? Porter Wright Morris & Arthur LLP “[T]he proposed safety measures may protect the business from potential health and safety liabilities.” “No cost to the City because the... program reclaims all costs from the industry.” “The cost to industry is minimal... unless it is shown that The nanoparticles in use are potentially harmful...”

14. 7.Confidentiality concerns. Porter Wright Morris & Arthur LLP

15. CONCLUSIONS Legitimate interest in public health. Governments should tread lightly when imposing regulations. Seek industry, scientific, and legal input. Carefully craft regulations to target reasonably foreseeable risks. Primary focus on learning and understanding potential risks. Preemptive strikes may do more harm than good. In the meantime, manufacturers should take responsibility for the EHS implications of their products consistent with existing products liability law and existing government regulation. Porter Wright Morris & Arthur LLP