Getting it right the first time: An environmental NGO

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Getting it right the first timeAn environmental
NGOs perspective on nanotechnology

• Comments for FDA public meeting on nanotechnology
  materials
• October 10, 2006
• John M. Balbus, MD, MPH

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Many applications for FDA to consider

• Direct Contact
• Drug delivery
• Therapeutic agents/devices
• Medical imaging
• Biomaterials
• Food additives
• Sunscreens
• Cosmetics/skin treatments

• Indirect Contact
• Food packaging

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Many products on the market
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FDA words do not inspire confidence
Few resources currently exist to assess the
risks
http//www.fda.gov/nanotechnology/regulation.html
Accessed October 4, 2006
Particle size is not the issue.
http//www.fda.gov/nanotechnology/regulation.html
Accessed October 4, 2006
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Size-related interactions

• Surface binding may bend proteins

Lynch et al (2006) Science STKE March 21
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8-hour skin penetration of QDs
NH2 Coating
PEG Coating
Ryan-Rasmussen et al., Tox Sci. 2006
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In-vitro tests of skin cells

• CNTs cause oxidative stress in cultured
  keratinocytes
• Shvedova et al., 2003, Manna et al., 2005
  Monteiro-Riviere et al., 2005
• Anatase nanoscale titanium dioxide more cytotoxic
  than rutile
• Sayes, et al., 2006

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Four Keys to Getting Nano Right

• Significant increase in government risk-research
  investment
• Effective regulations
• Voluntary interim standards
• Meaningful stakeholder engagement

Issues in Science Technology, Summer 2005
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Recommendations for FDA

• Increase level of risk research
• Seek pre-market authority for cosmetics/personal
  care products
• Maximize existing authorities
• Revisit weight-based exclusions under NEPA
• Voluntary information programs
• Labelling
• Consumer education
• Increase meaningful stakeholder involvement

www.ed.org/go/nano