Nanotechnology and Nanomaterial Personal Care Products: Necessary Oversight and Recommendations

Global Regulatory Issues for the Cosmetics Industry

Volumn , Issue , 2007, Pages 117-153

  Kimbrell, George A ^a  

^a International Center for Technology Assessment (CTA)   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

EID: 84882497684     PISSN: None     EISSN: None     Source Type: Book    
DOI: 10.1016/B978-081551567-8.50012-7     Document Type: Chapter

References (177)

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65. Oberdorster G., et al. Deposition Clearance and Effects in the Lung. Journal of Aerosol Medicine 1992, 5(3):179-187.
66. "Fixed" nanomaterials are immobilized in a solid matrix (e.g., tennis rackets reinforced with carbon nanotubes). On the other hand, "free" nanoparticles are suspended in the liquid or cream. Free particles are more easily dis persed and more quickly spread around. Free particles are also a form more conducive to being absorbed by organisms. These types of particles make up the largest percentage of the known nanomaterial consumer product market, including cosmetics and sunscreens.
67. See e.g., The Woodrow Wilson International Center for Scholars, Project on Emerging Nanotechnologies, Nanotechnology Consumer Products Inventory.
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72. Environmental Working Group, Skin Deep.
73. available at. http://www.ewg.org/issues/cosmetics/FDAwarning/index.php.
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76. Lademann J., et al. Penetration Profile of Microspheres in Follicular Targeting of Terminal Hair Follicles. Journal of Investigative Dermatology 2004, 132:168-172.
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80. Nanomaterial manufacturing can be done by either the "top-down" or the "bottom-up" method. Top-down manufacturing is the grinding or breaking down of a substance to the nanoscale while bottom-up involves building materials through chemical synthesis including self-assembly. See generally Royal Society Report at 25 and Table 4.1.
81. See, e.g., External Review Draft, Nanotechnology White Paper (hereafter EPA White Paper), at 36-37, prepared for the US Environmental Protection Agency by members of the Nanotechnology Workgroup, a group of EPA's Science Policy Council. Science Policy Council, US Environmental Protection Agency, Washington, DC 20460, December 2, 2005.
82. available at. http://www.epa.gov/osa/nanotech.htm.
83. Ibid. at 37, 40.
84. Colvin V. Responsible Nanotechnology: Looking Beyond the Good News. EurekAlert! Nanotechnology in Context November 2002, available at. http://www.eurekalert.org/context.php?context=nano&show=essays&e ssaydate=1102.
85. Maynard Andrew Nanotechnology: A Research Strategy for Addressing Risk. Woodrow Wilson International Center for Scholars, Project on Emerging Nanotechnologies July 2006, at 12.
86. The Woodrow Wilson International Center for Scholars, Project on Emerging Nanotechnologies, Nanotechnology Consumer Products Inventory.
87. Letter from Ken Kirk, Executive Director, National Association of Clean Water Agencies, to Stephen Johnson, Administrator, Environmental Protection Agency (February 14, 2006) (on file with author); Letter from Chuck Weir, Chair, Tri-TAC, to James Jones, Director, Office of Pesticide Programs, Environmental Protection Agency (January 27, 2006) (on file with author). Pat Phibbs, Pesticides: Examining Use of Nanoscale Silver in Washing Machines as Possible Pesticide, Daily Environment Report, May 15, 2006, at A-5-A-6.
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91. See e.g., The Royal Society and the Royal Academy of Engineering, Nanoscience and Nanotechnologies: Opportunities and Uncertainties, London (2004), at 42; External Review Draft, Nanotechnology White Paper (here after EPA White Paper), at 36-37, prepared for the US Environmental Protection Agency by members of the Nanotechnology Workgroup, a group of EPA's Science Policy Council. Science Policy Council, US Environmental Protection Agency, Washington, DC 20460 (December 2, 2005), at 42.
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94. Maynard Andrew Nanotechnology: A Research Strategy for Addressing Risk. Woodrow Wilson International Center for Scholars, Project on Emerging Nanotechnologies July 2006, 28-29.
95. Monterior-Riviere N., et al. Challenges for Assessing Carbon Nanomaterial Toxicity to the Skin. Carbon 2006, 44:1070-1078.
96. Kuzma Jennifer Nanotechnology in Agriculture and Food Production. Woodrow Wilson International Center for Scholars, Project on Emerging Nanotechnologies September 2006, 12.
97. Section on Environment, Energy, and Resources. ABA SEER CAA Nanotechnology Briefing Paper June 2006, 12-14. American Bar Association.
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103. See generally The Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C., Chapter 9 et seq.
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105. FDA, Nanotechnology Products, Frequently Asked Questions.
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107. See e.g., 21 U.S.C. §§ 321(p), 355(a), 360c(a)(1)(C).
108. Ibid.; 21 C.F.R. Parts 200 through 499.
109. 21 U.S.C. § 393(b)(2)(B).
110. See e.g., 58 Fed. Reg. 28195; 21 U.S.C. § 321(g)(1).
111. See e.g., 21 U.S.C. §§ 331(a), 343(a), 352(a), 362(a).
112. Center for Food Safety and Applied Nutrition. FDA Authority Over Cosmetics 2006, FDA, available at, 21 C.F.R. pts. 361-363, §740.10(a); 21 C.F.R. §§ 7.40-7.59. http://www.cfsan.fda.gov/dms/cos-206.html.
113. FDA, Regulation of Nanotechnology Products.
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115. FDA, FDA and Nanotechnology Products, Frequently Asked Questions.
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121. Small Sizes that Matter: Opportunities and risks of Nanotechnologies June 3, 2005, The Allianz Group and the Organisation for Economic Co-operation and Development (OECD), at § 6.4, at 30.
122. Opinion on the Appropriateness of Existing Methodologies to Assess the Potential Risks Associated with Engi neered and Adventitious Products of Nanotechnologies adopted September 28-29, 2005, European Commission's Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR), at 6 (emphasis added); ibid. at 34.
123. The Royal Society and the Royal Academy of Engineering. Nanoscience and nanotechnologies: Opportunities and uncertainties, London 2004, See e.g., at 49 (emphasis added).
124. Tran, et al. A Scoping Study to Identify Hazard Data Needs For Addressing The Risks Presented By Nanoparticles and Nanotubes. Institute of Occupational Medicine Research Report December 2005, at 34 (emphasis added).
125. Opinion on the Appropriateness of Existing Methodologies to Assess the Potential Risks Associated with Engineered and Adventitious Products of Nanotechnologies adopted September 28-29, 2005, 6. European Commission's Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR), at 32.
126. Moran Nuala Nanomedicine Lacks Recognition in Europe. 24 Nature Biotechnology Febuary 2006, No. 2.
127. Maynard Andrew Nanotechnology: The Next Big Thing, or Much Ado about Nothing?. Annals of Occupational Hygiene September 2006, at 7.
128. Maynard, et al. Safe Handling of Nanotechnology. Nature November 16, 2006.
129. Nel Andre, et al. Toxic Potential of Materials at the Nanolevel. Science 2006, 311:622.
130. Nel Oberdorster, et al. Principles for Characterizing the Potential Human Health Effects from Exposure to Nanomaterials: Elements of a Screening Strategy. Particle and Fibre Toxicology 2005, 8(2). at 1.0.
131. The Royal Society and the Royal Academy of Engineering. Nanoscience and Nanotechnologies: Opportunities and Uncertainties, London 2004.
132. FDA, FDA Forms Nanotechnology Task Force (August 9, 2006).
133. available at. http://www.fda.gov/bbs/topics/NEWS/2006/NEW01426.html.
134. FDA, FDA Nanotechnology Public Meeting.
135. available at. http://www.fda.gov/nanotechnology/meetingl0l0.html.
136. 71 Fed. Reg. 19523 April 14, 2006.
137. The Project on Emerging Nanotechnologies at the Woodrow Wilson International Center for Scholars, The Nanotechnology Consumer Products Inventory Analysis.
138. Weiss Rick Nanotech Product Recalled in Germany April 4, 2006, A2. Washington Post.
139. The petitioning organizations are ICTA, FOE, Greenpeace International, The Action Group on Erosion, Technology, and Concentration (ETC Group), Clean Production Action, The Center for Environmental Health (CEH), Our Bodies Ourselves, and The Silicon Valley Toxics Coalition (SVTC).
140. Available at. http://www.icta.org/doc/Nano%20FDA%20petition%20final.pdf.
141. Davidson Keay FDA Urged to Limit Nanoparticle Use in Cosmetics and Sunscreens May 17, 2006, San Francisco Chronicle.
142. See 21 C.F.R. § 10.85(a).
143. See ICTA FDA Nano Petition.
144. Ibid.; see 58 Fed. Reg. 28195; 21 U.S.C. § 321(g)(1).
145. Kulinowski, Colvin Environmental Implications of Engineered Nanomaterials. 1 Nanotechnology Law & Business 2004, 52:53. US Food and Drug Administration, HHS, Sunscreen Drug Products For Over-The-Counter Human Use; Final Monograph, 64 Fed. Reg. 27666-27693, 27671 (1999). FDA used the term "micronized" and the agency has not clarified whether or not this term was meant to be inclusive of nanoparticles. See also.
146. See 21 U.S.C. §§ 321(p), 355(a).
147. Statement on Zinc Oxide In Sunscreens adopted September 20, 2005, See, e.g., European Commission's Scientific Committee on Cosmetic and Non-Food Products (SCCNFP)European Commission's Scientific Committee on Cosmetic and Non-Food Products (SCCNFP), available at, available at (finding insufficient evidence presented for a finding of safety). http://europa.eu.int/comm/health/phrisk/committees/04sccp/docs/sccpo00m. pdf.
148. The Royal Society and the Royal Academy of Engineering. Nanoscience and Nanotechnologies: Opportunities and Uncertainties, London 2004, see also, at 73.
149. Hidaka, et al. In Vitro Photochemical Damage to DNA, RNA and Their Bases by an Inorganic Sunscreen Agent on Exposure to UVA and UVB radiation. Journal of Photochemistry and Photobiology 1997, 111:205-213. See e.g.
150. Dunford, et al. Chemical Oxidation and DNA Damage by Inorganic Sunscreen Ingredients. FEBS Letters 1997, 418(1-2):87-90.
151. Donaldson, et al. Free Radical Activity Associated with the Surface of Particles: A Unifying Factor in Determining Biological Activity?. Toxicology Letters 1996, 88:293-298.
152. 21 C.F.R. §§ 2.5(a) (imminent hazard), 7.45(a) (recall).
153. Taylor Michael Regulating the Products of Nanotechnology: Does FDA Have the Tools It Needs? Woodrow Wilson International Center for Scholars. Project on Emerging Nanotechnologies October 5, 2006.
154. The broader societal and bioethical implications of nanotechnology are beyond the scope of this chapter. For more information, see generally nanotechnology publications of the ETC Group.
155. available at. http://www.etcgroup.org/en/.
156. Cosmetics Toiletries and Fragrances Association (CTFA), Comments on the ICTA Legal Petition.
157. Weiss Rick Nanotechnology Risks Unknown; "Insufficient Attention Paid to Potential Dangers. Report Says, Washington Post A12 September 26, 2006, See e.g.
158. Maynard Andrew Nanotechnology: A Research Strategy for Addressing Risk, Woodrow Wilson International Center for Scholars. Project on Emerging Nanotechnologies July 2006, at 23.
159. CTFA Comments on ICTA Petition.
160. Maynard Andrew Nanotechnology: The Next Big Thing, or Much Ado about Nothing? Annals of Occupational Hygiene September 2006, at 7.
161. Oberdorster, et al. Principles for Characterizing the Potential Human Health Effects from Exposure to Nanomaterials: Elements of a Screening Strategy. 2 Particle and Fibre Toxicology 2005, 8. at 1.0.
162. Perspectives on the Precautionary Principle 1999, 2-3. Simply stated, the precautionary principle stands for the idea that inaction is preferable to action in circumstances where taking action could result in serious or irreversible harm. See generally. R. Harding, E. Fisher (Eds.).
163. Betton Cliff Presentation, REACH September 14, 2006, Product Safety Assessment Ltd, Health and Beauty America Regulatory Summit, New York City, NY.
164. Piller Science's Tiny, Big Unknown. Los Angeles Times June 1, 2006, Al.
165. Report Findings, Report of the Woodrow Wilson International Center for Scholars. Project on Emerging Nanotechnologies September 19, 2006, Peter Hart Research Associates.
166. Rundle R.L. This War Against Germs Has a Silver Lining. Wall Street Journal June 6, 2006, at D1.
167. Letter from Ken Kirk, Executive Director, National Association of Clean Water Agencies, to Stephen Johnson, Administrator, Environmental Protection Agency (February 14, 2006) (on file with author); Letter from Chuck Weir, Chair, Tri-TAC, to James Jones, Director, Office of Pesticide Programs, Environmental Protection Agency (January 27, 2006) (on file with author); Pat Phibbs, "Pesticides: Examining Use of Nanoscale Silver in Washing Machines as Possible Pesticide", Daily Environment Report (May 15, 2006), at A-5-A-6.
168. 7 U.S.C. § 136a(a).
169. TM Miracle Food Storage Containers. http://www.sharperimage.com/us/en/catalog/productdetails/skuZN020.
170. TM Miracle Food Storage Containers, HYPERLINK. http://web.archive.org/web/20060208021530/.
171. http://www.sharperimage.com/us/en/catalog/productdetails/skuZN020.
172. http://web.archive.org/web/20060208021530/.
173. "See also Rick Weiss, EPA to Regulate Nanoproducts sold as Germ-killing, Washington Post, at Al, November 23, 2006.". http://www.sharperimage.com/us/en/catalog/productdetails/skuZN020.
174. A lifecycle assessment is the "systematic analysis of the resources usages (e.g., energy, water, raw materials) and the emissions over the complete supply chain from the cradle of primary resources to the grave of recycling or disposal:" The Royal Society and the Royal Academy of Engineering. Nanoscience and Nanotechnologies: Opportunities and Uncertainties, London 2004, at 32.
175. Reynolds Glenn Nanotechnology and Regulatory Policy: Three Futures 2003, 179:185. 17 Harv. J. L. & Tech.
176. Davis J. Managing the Effects of Nanotechnology. Woodrow Wilson International Center for Scholars 2006, See, e.g., Project on Emerging Nanotechnologies, Washington, DC.