CRITICAL ISSUES AFFECTING THE FUTURE OF NANO TECHNOLOGIES

1. CRITICAL ISSUES AFFECTINGTHE FUTURE OF NANO TECHNOLOGIES @ Woodrow Wilson International Center for Scholars Todd Kuiken, Ph.D. Phone: (202) 691-4398 Email: todd.kuiken@wilsoncenter.org

2. Size/Scope/ Future • RISKS • OVERSIGHT ISSUES • PUBLIC CONFIDENCE/ ACCEPTANCE

3. What’s so special about nano • At the nanoscale, scientists can start affecting the properties of materials • In some cases, simply making things smaller changes their properties • A chemical may take on a new color or start to conduct electricity • Nanoscale materials tend to be more chemically reactive than their macro-sized counterparts because they have more surface area

4. Not just about shrinking • Nanotechnology fundamentally changes the internal structure of compounds • Pure carbon takes two familiar forms: diamond and graphite • Carbon Nanotubes is one of the earliest forms of nanotechnology • By arranging carbon into precise nano-meter scale structures, a new product can be made that is up to 30 times stronger than steel and 1/6th the weight

5. Nano Market Size • Revenue involving nanotechnologies is predicted to reach $2.5 trillion by 2015 • Two trillion of which will be directly attributable to nano-enabled products and about $3 billion associated with nanomaterials. (Lux Research, 2009) • Nanomaterials associated with these end products will enter the waste stream at numerous points along the supply chain • All of which need to be evaluated from a LCA standpoint.

6. More than 1,200 companies, universities, government laboratories, and other organizations across all 50 U.S. states and the District of Columbia are involved in nanotechnology • The top 3 sectors for companies working in nanotechnology (each with over 200 entries) are: materials; tools and instruments; and medicine and health

7. Nano is here and wide spread • The Project on Emerging Nanotechnologies (PEN) consumer products inventory shows over 1,000 nanotechnology-enabled consumer products have been made available to consumers around the world • Between 2006 and 2009 the number of nano-enabled consumer products nearly tripled.

8. findNano iPhone App

11. Nano R&D James Tour used the following based on his work at Rice University • Passive • 0-5 • Hybrid • 7-12 • Active • 15-50

12. What can you expect in the next 15 years? • Smart drugs • Military applications • Next-generation computer processing • Programmed biology • Complex materials • Meta-materials • Energy generation and use

13. Life Cycle Assessment Issues and Needs

14. LCA: Limited Studies • Khana et al.(2008) examined the life cycle energy consumption of carbon nanofibers compared to traditional materials like aluminum, steel and polypropylene. • Their results suggest that the energy requirements for CNFs are higher than that of traditional materials. • The study was conducted on an equal mass basis however and cannot be extrapolated to potential products enhanced with these materials • It is not however extreme to hypothesize that the amount of material needed will be less compared to traditional materials

15. …limited studies • Satish Joshi (2008) looked at whether nanoclay composites improved the environmental sustainability of biopolymers • On a unit mass basis, nanoclay production results in lower environmental burdens compared to common biobased polymers across the life cycle of the material • The study goes on to say that substituting nanoclays for certain polymers could improve the environmental performance however product life-cycle assessments are necessary

16. Lack of Data • “comprehensive, transparent, representative, and publicly available data” is needed in order to carry out the requirements outlined in the ISO standards for LCA (Joshi, 2008) • The studies fail to capture the full life cycle of the product because they primarily follow a cradle to gate scenario of a specific material, leaving out the market use and end of life scenarios. • Has to do with the lack of environmental health and safety data available for nanomaterials and the products they are incorporated into

17. No Instruments No Data • A major obstacle for determining the environmental effects of specific nanomaterials is the slow development of metrology • Without proper instrumentation, the ability to monitor emissions and conduct full scale ecosystem and human health effect studies on nanomaterials will be hindered • Without this data full-scale LCAs cannot be properly performed

18. A sample of the conclusions from 2006/2009 LCA Workshop • Major efforts are needed to fully assess potential risks and environmental impacts • There is a need for protocols and practical methodologies for toxicology studies, fate and transport studies and scaling approaches • International cooperation is needed • Further research is needed to gather missing relevant data and to develop user-friendly eco-design screening tools, especially ones suitable for use by small and medium sized enterprises

19. Nano Remediation In situ Small size Greater Surface Area Higher Reactivity Lower Cost (potentially) Variety of Materials: Zeolites Metal Oxides Carbon-based nanomaterials Enzymes Bi-metallic nanoparticles (BNP)

20. Chemistry of nZVI Can be used in both aerobic and anaerobic conditions Reacts with halogenated hydrocarbons TCE + Fe0 HC products + Cl- +Fe2+/Fe3+

21. Potential Pollutants treated with nZVI Chlorinated methanes Carbon tetrachloride (CCl4) Chloroform (CHCl3) Dichloromethane (CH2Cl2) Chloromethane (CH3Cl)Trihalomethanes Bromoform (CHBr3) Dibromochloromethane (CHBr2Cl) Dichlorobromomethane (CHBrCl2) Chlorinated benzenes Hexachlorobenzene (C6Cl6) Pentachlorobenzene (C6HCl5) Tetrachlorobenzenes (C6H2Cl4) Trichlorobenzenes (C6H3Cl3) Dichlorobenzenes (C6H4Cl2) Chlorobenzene (C6H5Cl) Chlorinated ethenes Tetrachloroethene (C2Cl4) Trichloroethene (C2HCl3) cis-Dichloroethene (C2H2Cl2) trans-Dichloroethene (C2H2Cl2) 1,1-Dichloroethene (C2H2Cl2) Vinyl chloride (C2H3Cl)Pesticides DDT (C14H9Cl5) Lindane (C6H6Cl6) Other polychlorinated hydrocarbonsPCBs Dioxins Pentachlorophenol (C6HCl5O) Organic dyes Orange II (C16H11N2NaO4S) Chrysoidine (C12H13ClN4) Tropaeolin (C12H9N2NaO5S) Acid Orange Acid Red Other organic contaminants N-nitrosodimethylamine (NDMA) (C4H10N2O) TNT (C7H5N3O6) Heavy Metal ions Mercury (Hg2+) Nickel (Ni2+) Silver (Ag+) Cadmium (Cd2+) Inorganic anions Dichromate (Cr2O72-) Arsenic (AsO43-) Perchlorate (ClO4-) Nitrate (NO3-)

22. Benefits of in situ nZVI Cost Example: New Jersey Manufacturing Site Pump & treat $4.16M PRB $2.2M nZVI $0.45M • Cost Reduction (PARS, 2008) Estimate of the potential cost savings: $87-98B using nanoremediation over 30 years • Reduction in time to clean up the site: • Pump & Treat about 18 years • nZVI 99% reduction in days (Zhang, 2003) • Less worker exposure to contaminated site • Fewer environmental disturbances

23. Nano for remediation • There are over 60 sites across the globe that have utilized nanomaterials to clean up hazardous waste sites • Nanoparticles are injected directly into the ground via wells

24. Nano-Peroxide Results Boomsnub Site, USEPA http://yosemite.epa.gov/R10/CLEANUP.NSF/sites/boomrv (Continental Remediation, LLC)

25. Storage tank located adjacent to river Soil/groundwater contaminated with No. 6 oil Excavation not practical due to utilities around and under the site Discharge to river stopped Free product was reduced from 13” to 1” in monitoring wells after 30 days (Continental Remediation, LLC (2007))

26. Potential Implications Fate and Transport Possibility of nanoclusters carrying sorbed contaminants (Gilbert, 2007) Possible effect on microbes in parallel bioremediation (Hochella, 2005) Toxicity Excess free chelating Fe linked to DNA damage lipid peroxidation & oxidative protein damage (Valko, 2005) Inhalation exposures to FeO nanoparticles lead to reactive oxidative stress (Keenan,2008) Mammalian nerve cells experience oxidative stress (Phenrat, 2009)

28. European vs. U.S. Comparing two regulatory structures

29. TSCA • Pre-manufacture notice/review of new chemicals and significant new uses • 50 pre-manufacture notices received for nanomaterials • Significant New Use Rules for nanomaterials • Restrictions on existing chemicals • “Unreasonable risk” standard • Rarely used • Nanomaterials – the “new” versus “existing” determination • Test rules • Multi-pronged showing by EPA required • EPA may issue such test rules for certain nanomaterials • Reporting requirements • EPA may soon apply to certain nanomaterials • Nanoscale Materials Stewardship Program

30. REACH • Registration requirements – no data/no market • Eliminates distinction between new versus existing chemicals • Phase-in and non-phase-in chemicals • Tonnage/toxicity determine information requirements • Application to nanomaterials • Appropriate measures to control risk • Applies to nanomaterials registered under REACH • Evaluation • Dossier (completeness) • Substance (clarify “suspicions of risks”) • Authorization • Prioritizes substances of very high concern • Application process shifts burden to manufacturers/importers • Restriction • Risk to human health/environment addressed on Community-wide basis • Not yet used

31. Key differences • Pre-manufacture review/requirements • Registration versus pre-manufacture review • New versus existing chemicals distinction • Scope of information required • Information and data collection • Scope and process • Confidential business information • Regulatory controls • No TSCA equivalent to REACH authorization process • No TSCA equivalent to “appropriate measures to control risk” requirement • Premature to compare TSCA and REACH restriction processes and standards

32. Comparative analysis: food • Commonalities in EU & US regulatory systems • Structure • Product categories • Risk • Regulatory tools • Pre-market review & approval • Post-market monitoring, inspection, recall, & labelling • Differences in EU & US regulatory systems • Differing categories • General regulation of nanotechnologies/materials

33. Food regulation: key elements • Pre-market review – general regulation • EU proposed amendment to novel foods regulation • New foods produced with new technologies, including nanoscience • Safety assessment • Mandatory labelling • US no comparable general regulation • Pre-market review – case-by-case approach • EU & US - new products/ new uses of existing products • Molecular structure • May also consider particle size

34. Food regulation: key elements • Information collection • EU & US regulators recognize limitations • Affects risk assessment • Legal differences affect availability of information to regulators • Regulatory agencies may be able to share confidential information based on agreements to maintain confidentiality

35. Comparative analysis: cosmetics • Commonalities in EU & US regulatory systems • Structure • Regulatory tools • Differences in EU & US regulatory systems • Differing definitions (differentiation of drugs) • General regulation of nanotechnologies/materials

36. Cosmetics regulation: key elements • Pre-market review • EU Cosmetics Directive • Cosmetic product safety assessment • Mandatory reporting to Commission for new products • EU proposed Cosmetics Regulation • Specifically defines nanomaterials • Information reporting for nanomaterials • Labelling • No comparable US provisions

37. Cosmetics regulation: key elements • Case-by-case approach • EU & US both have authority to restrict specific nanomaterials in cosmetics • EU & US have similar post-market authorities • Recall • Inspection of records • Good manufacturing practices • Labelling

38. Cosmetics regulation: key elements • Information inadequacies • EU & US regulators recognize limitations in their information on nanomaterials in products • Information for risk assessment • Information sharing • Regulatory agencies may be able to share confidential information based on agreements to maintain confidentiality • US law prohibits disclosure of trade secrets

39. EPA Regulatory Response

40. EPA SAP on NanoSilver • Held in November 2009 • Examined the hazards and exposures from nanosilver products • General recommendations: • More data is needed • OPP should determine data needs on a case by case basis • LCA can be adopted for nanoproducts

41. New Rules… • EPA is preparing to announce a new interpretation of FIFRA and propose a new policy • Nanoscale material is reportable under FIFRA section 6(a)(2) • Applies to new and already registered products • Based on an interpretation of FIFRA on the governing reporting of unreasonable adverse effect

42. New EPA Policy • An active or inert ingredient would be considered new if it is a nanoscale material • Would apply even when a non-nanoscale form of that same material is already registered • Nanosilver would be considered “new” even though the bulk form is already registered

43. Regulatory response has been slow • TSCA reform (introduced April 15th) • Administrator can consider: • Size or size distribution • Shape and surface structure • Reactivity • Any other properties that may significantly affect the risks posed • EPA Nanosilver SAP • EPA SNUR on CNTs • Effect of REACH • CPSC for the first time has a small budget to examine nanoproducts • As of yet, no federal agency has made a determination that nanomaterials are a “new” material

44. State Regulatory Responses

45. State Regulations • Massachusetts • Nanotechnology: Considerations for Safety Development • DEP added nanomaterials to list of emerging contaminants • Massachusetts Interagency Committee on Nanotechnology • MassDEP, Dept of Public Health, Division of Occupational Safety, Office of Technical Assistance, Toxic Use Reduction Institute, Office of Business Development • Nanoremediation concerns • Requires approval from DEP before it can be used • City of Cambridge • Developed a nanoscale materials survey which will be distributed through the fire department (first responder issues)

46. State Regulations • California • Further along the regulatory path than other states • Data call in for carbon nanotubes • Draft Regulation for Safe Consumer Products • Considers nanomaterials to be under 1,000 nm • All nanomaterials will be considered a toxicity trait • Would be considered as hazardous and subject to a host of regulations

47. Public Engagement

48. Cultural Cognition of Nanotechnology Risks • The CCP/PEN studies examined the cultural cognition of nanotechnology risk • Two main goals: • Understand whether and how cultural cognition might be expected to affect public opinion toward nanotechnology • Generate insights that might be used to form strategies for communicating scientifically sound information about nanotechnology in forms that make it accessible to citizens of divers cultural outlooks

49. Techno-culture Issues • These arise from problematic aspects of the role of technology within the social systems and structures from which, and into which, nanotechnologies are emerging • Examples include: • An over-reliance on technological fixes to manage problematic effects (rather than addressing underlying causes of those effects) • Overestimation of our capacity to predict and control technologies (particularly within complex and dynamic biological systems) • Technological mediation of our relationship with and experience with nature (and associated marginalization of natural values)

50. Social and ethical issues associated with emerging nanotechnologies • Determinate • It is possible to identify many of the social and ethical issues • Immediate • It is not too soon to begin considering many of the issues • Significant • Addressing the issues is crucial to the responsible development of emerging nanotechnologies • Actionable • In many cases, there are steps that can be taken now by actors, including those in government, to address the issues