1. Nanotechnology and Nanomaterials in Consumer Products: Regulatory Challenges and Necessary Amendments George A. Kimbrell The International Center for Technology Assessment FDA Public Meeting on Nanotechnology October 10, 2006 October 10, 2006

2. CTA is a Washington, D.C.-based non-profit, bi- partisan organization committed to providing the public with full assessments and analyses of technological impacts on society. CTA explores the environmental, human health, economic, ethical, social and political impacts that can result from the applications of technology or technological systems.

3. Measures of Nanotechnology’s Maturation R&D surging: global nanotech R&D= $9 billion, with $1 trillion estimated for 2015 (Lux Research 2006). R&D surging: global nanotech R&D= $9 billion, with $1 trillion estimated for 2015 (Lux Research 2006). Term “nano” approaches ubiquitous status in U.S. society and media (>18,000 citations in U.S. media in 2005). Term “nano” approaches ubiquitous status in U.S. society and media (>18,000 citations in U.S. media in 2005). The “gold rush” for nano-patents continues- over 4,000 U.S. patents issued to date (Lux Research 2006). The “gold rush” for nano-patents continues- over 4,000 U.S. patents issued to date (Lux Research 2006). Perhaps most importantly, nanotechnology commercialization is moving forward at a rapid rate… Perhaps most importantly, nanotechnology commercialization is moving forward at a rapid rate…

4. Nanomaterials in Consumer Products Thousands of tons of nanomaterials are already being produced each year. Thousands of tons of nanomaterials are already being produced each year. >$32 billion in nano-products sold in 2005, 2X the total of 2004 (Lux Research 2006). >$32 billion in nano-products sold in 2005, 2X the total of 2004 (Lux Research 2006). Wilson Center’s Project on Emerging Nanotechnologies (2006): 320 self-identified nano-products now on U.S. market shelves. Wilson Center’s Project on Emerging Nanotechnologies (2006): 320 self-identified nano-products now on U.S. market shelves. Products include paints, coatings, sporting goods, sunscreens, cosmetics, personal care products, stain- resistant clothing, food and food packaging, and light emitting diodes used in computers, cell phones, and digital cameras. Products include paints, coatings, sporting goods, sunscreens, cosmetics, personal care products, stain- resistant clothing, food and food packaging, and light emitting diodes used in computers, cell phones, and digital cameras.

5. I. Nanomaterials in Consumer Products: The Future is Now (Photo by David Hawxhurst-Woodrow Wilson International Center for Scholars.)

6. No Where Are Nanomaterials Reaching the Consumer Faster than in Personal Care Products Wilson Center’s Consumer Product Datebase: Wilson Center’s Consumer Product Datebase: –largest single category (125 products) is health and fitness (including sunscreens, cosmetics, and other personal care products). Friends of the Earth Nanomaterials, Sunscreens and Cosmetics Report Friends of the Earth Nanomaterials, Sunscreens and Cosmetics Report –At least 116 cosmetics, sunscreens, and personal care products containing nanomaterials commercially available.

7. Nanomaterials in Consumer Products: The Personal Care Industry Leading the Way (Photo by David Hawxhurst-Woodrow Wilson International Center for Scholars.)

8. Case Study: Nano-Silver Consumer Products brooms, food storage, refrigerators, air filters, drywall, paint, medical coatings, sports clothes, washing machine brooms, food storage, refrigerators, air filters, drywall, paint, medical coatings, sports clothes, washing machine Ex’s- Samsung’s Silvercare Washer; Shaper Image’s Fresher Longer Miracle Food storage Ex’s- Samsung’s Silvercare Washer; Shaper Image’s Fresher Longer Miracle Food storage

9. What Does All This Commercialization Mean? FDA is charged with overseeing the safety and efficacy of many of these products, the first wave of nano- products. Thus, FDA’s First Public Meeting is a necessary development, but is dangerously overdue; ditto FDA’s recently created Nanotechnology Task Force FDA is charged with overseeing the safety and efficacy of many of these products, the first wave of nano- products. Thus, FDA’s First Public Meeting is a necessary development, but is dangerously overdue; ditto FDA’s recently created Nanotechnology Task Force

10. The time for action is now FDA should immediately prioritize human health and environmental concerns FDA should immediately prioritize human health and environmental concerns –A framework that adequately accounts for the fundamental differences of nanomaterials and protects human health and the environment –Much more robust EHS research (EHS currently only 4% of NNI’s annual $1 billion budget)

11. At the Nano-scale, Size Matters: ‘Nano’ is best understood to mean fundamentally different Materials engineered or manufactured to the nano-scale exhibit different fundamental physical, biological, and chemical properties Materials engineered or manufactured to the nano-scale exhibit different fundamental physical, biological, and chemical properties –Quantum physics effects –Exponentially increased surface area These new properties (“nano-ness”) These new properties (“nano-ness”) create unique and unpredictable human health and environmental risks –increased surface area creates increased reactivity and enhanced intrinsic toxicity –Size creates unprecedented mobility to human body and environment

12. Human Health Risks Enhanced toxicity: some nanoparticles shown to cause DNA mutation, structural damage to mitochondria and even cell death in laboratory studies. Enhanced toxicity: some nanoparticles shown to cause DNA mutation, structural damage to mitochondria and even cell death in laboratory studies. –Nanoparticles of titanium dioxide and zinc oxide (cosmetics and sunscreens) photoactive in studies, producing free radicals and causing DNA damage –Carbon fullerenes ( Carbon 60 ): Adverse impacts on aquatic species and low levels have been found to cause damage to human liver cells

13. Human Health Risks Unprecedented mobility: Unprecedented mobility: –Due to size, nanoparticles more easily taken up by the human body and can cross biological membranes, cells, tissues and organs more efficiently than larger particles. –Once in the blood stream, nanomaterials can be transported around the body and can be taken up by organs and tissues including the brain, heart, liver, kidneys, spleen, bone marrow and nervous system. –Entry through inhalation or ingestion; jury still out on ease of skin penetration.

14. A new class of manufactured non-biodegradable pollutants Pathways: during manufacturing, transport, use, or disposal (e.g., nano- cosmetics or other nano-personal care products: washed off in the shower and join water waste streams.) Pathways: during manufacturing, transport, use, or disposal (e.g., nano- cosmetics or other nano-personal care products: washed off in the shower and join water waste streams.) Environmental Impacts: Environmental Impacts: –Mobility-ability to persist; reach places larger particles cannot; move with great speed through aquifers and soils; settle slower. –Transportation-large and active surface for absorbing smaller contaminants that could “hitch a ride” over long distances –Reactivity-interactions with substances present in the soil could lead to toxic compounds –Durability and Bioaccumulation- nano-aluminum and stunted plant growth; nano-silver and microorganisms

15. A new class of manufactured non-biodegradable pollutants Management Challenges: Detection and Removal?? Management Challenges: Detection and Removal?? –New protocols and cost-effective technologies for measuring, monitoring, and controlling nanomaterials are required

16. FDA is charged with regulating the safety and effectiveness of most food, drugs, and cosmetics, as well as other substances such as medical devices, animal feed, and combination products (21 U.S.C. Ch. 9 et seq.) FDA is charged with regulating the safety and effectiveness of most food, drugs, and cosmetics, as well as other substances such as medical devices, animal feed, and combination products (21 U.S.C. Ch. 9 et seq.) –Many currently available nano-products fall under FDA’s broad regulatory scheme –Cosmetics (21 U.S.C. § 361 et seq) –Sunscreens (21 U.S.C. § 321(g)) (classified as human drugs ) FDA is aware of “several FDA regulated products [that] employ nanotechnology,” including “cosmetic products claim[ing] to contain nanoparticles to increase the stability or modify the release of ingredients” and “nanotechnology-related claims made for certain sunscreens.” FDA is aware of “several FDA regulated products [that] employ nanotechnology,” including “cosmetic products claim[ing] to contain nanoparticles to increase the stability or modify the release of ingredients” and “nanotechnology-related claims made for certain sunscreens.”

17. FDA treats nanomaterial product ingredients no differently than bulk material ingredients or products. FDA’s current stance is to regulate (or decline to regulate) based on safety assessment of the same material in bulk form (e.g., nano- sunscreens) FDA treats nanomaterial product ingredients no differently than bulk material ingredients or products. FDA’s current stance is to regulate (or decline to regulate) based on safety assessment of the same material in bulk form (e.g., nano- sunscreens) FDA “believes that the existing battery of pharmacotoxicity tests is probably adequate for most nanotechnology products that we regulate. Particle size is not the issue.” FDA “believes that the existing battery of pharmacotoxicity tests is probably adequate for most nanotechnology products that we regulate. Particle size is not the issue.”

18. The Views of the Scientific Community: New Nano-specific Toxicity Testing Paradigms are Required The European Commission’s Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR): The European Commission’s Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR): –“Experts are of the unanimous opinion that the adverse effects of nanoparticles cannot be predicted (or derived) from the known toxicity of material of macroscopic size, which obey the laws of classical physics.” The U.K. Royal Society and Royal Academy of Engineering: The U.K. Royal Society and Royal Academy of Engineering: –“Substances made using nanotechnology should be considered new chemicals and undergo extra safety checks before they hit the market to ensure they do not pose a threat to human health.” New paradigms of toxicology testing have been proposed (Nel et al., Science (2006); Oberdorster et al., Particle and Fibre Toxicology (2005)). New paradigms of toxicology testing have been proposed (Nel et al., Science (2006); Oberdorster et al., Particle and Fibre Toxicology (2005)).

19. First-ever Legal Action On Risks Of Nanotechnology First-ever Legal Action On Risks Of Nanotechnology May 2006: CTA and coalition of consumer, health, and environmental groups file legal petition challenging FDA’s failure to regulate human health and environmental threats from nanomaterials. May 2006: CTA and coalition of consumer, health, and environmental groups file legal petition challenging FDA’s failure to regulate human health and environmental threats from nanomaterials. –The petition calls for: Comprehensive nanomaterial-specific regulations Comprehensive nanomaterial-specific regulations New paradigms of nano-specific toxicity testing New paradigms of nano-specific toxicity testing Classification of nanomaterials as new substances Classification of nanomaterials as new substances Mandatory nanomaterial product and ingredient labeling Mandatory nanomaterial product and ingredient labeling Compliance with the National Environmental Policy Act (NEPA) Compliance with the National Environmental Policy Act (NEPA)

20. Petition Focus: Nano-sunscreens Sunscreens are classified by FDA as human drugs and should be subject to rigorous pre-market regulation. Sunscreens are classified by FDA as human drugs and should be subject to rigorous pre-market regulation. Red flags regarding free radical creation and DNA damage; unanswered questions about skin penetration. Red flags regarding free radical creation and DNA damage; unanswered questions about skin penetration. Despite their unique dangers and patented differences, FDA currently considers nano- sunscreens equivalent to bulk material sunscreens. Despite their unique dangers and patented differences, FDA currently considers nano- sunscreens equivalent to bulk material sunscreens. Petition calls for nano-sunscreen recall until manufacturers submit and FDA reviews pre- marketing testing data proving the drugs’ safety and efficacy. Petition calls for nano-sunscreen recall until manufacturers submit and FDA reviews pre- marketing testing data proving the drugs’ safety and efficacy.

21. Conclusions Learn from the past: FDA must act quickly if it hopes to avoid repeating the mistakes of past federal agency regulatory failures of “wonder” materials or technologies (e.g., asbestos, CFCs, DDT, PCBs) Learn from the past: FDA must act quickly if it hopes to avoid repeating the mistakes of past federal agency regulatory failures of “wonder” materials or technologies (e.g., asbestos, CFCs, DDT, PCBs) Adequate Regulation: A regulatory framework is needed that protects workers, the general public and the environment from the impacts of nanomaterials throughout their lifecycle Adequate Regulation: A regulatory framework is needed that protects workers, the general public and the environment from the impacts of nanomaterials throughout their lifecycle Much more robust EHS Study: Adequate, publicly available, independent, peer-reviewed safety studies on the environmental and health impacts of nanomaterials Much more robust EHS Study: Adequate, publicly available, independent, peer-reviewed safety studies on the environmental and health impacts of nanomaterials

22. For More Information For More Information George A. Kimbrell International Center for Technology Assessment (202) 202-547-9359 gkimbrell@icta.org, www.icta.org gkimbrell@icta.orgwww.icta.org gkimbrell@icta.orgwww.icta.org