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Nanotechnology Standards and International Legal Considerations

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Nanotechnology Standards

Part of the book series: Nanostructure Science and Technology ((NST))

Abstract

Many emerging technologies of the last century have been structured or defined through the standards development process, sometimes either preceded or eventually followed by adaptations in the law.

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Notes

  1. 1.

    In the United States, for example, the Occupational Safety and Health Administration’s (OSHA) regulation setting safety requirements for grain elevators was almost 10 years in the making following the introduction of voluntary standard on the same topic. Setting Safety Standards, Regulation in the Public and Private Sectors, Ross E. Cheit, UNIVERSITY OF CALIFORNIA PRESS, 1990, University of California Press, E-books collection 1982–2004, Part 2. http://publishing.cdlib.org/ucpressebooks/view?docId=ft8f59p27jchunk.id=d0e4470toc.depth=1toc.id=d0e4449brand=ucpress .

  2. 2.

    The Emerging Role of Private Social and Environmental International Standards in Economic Globalization. Jason Morrison, Pacific Institute and Naomi Roht-Arriaza, UC Hastings College of Law. International Environmental Law Committee Newsletter. Volume 1, Number 3. Winter/Spring 2006, pp. 10–35.

  3. 3.

    http://shop.bsigroup.com/upload/Standards%20%20Publications/Nanotechnologies/Nano_Presentation.ppt#308,25,Terminology and nomenclature for nanotechnologies.

  4. 4.

    http://www.astm.org/Standards/E2456.htm.

  5. 5.

    http://shop.bsigroup.com/en/Browse-By-Subject/Nanotechnology/Terminologies-for-nanotechnologies/.

  6. 6.

     The US National Institute for Standards and Technology (NIST) has identified more than 20,000 citations of standards incorporated by reference in procurement and regulatory documents. An online interactive database available at http://standards.gov/sibr/query/index.cfm demonstrates the extensive use of voluntary standards throughout the U.S. Government. Eleventh Annual Report on Federal Agency Use of Voluntary Consensus Standards and Conformity Assessment, NIST, NISTIR 7503, May 2008, p. 2.

  7. 7.

    http://www.epa.gov/ttn/emc/methods/method24.html#wtsa.

  8. 8.

    According to the ISO, this arrangement also poses major challenges to the formal international standardization system, since it calls for a considerable expansion of European standardization activities. An attempt to address this tension was addressed, however, by the establishment of agreements between the international standardizing organizations of ISO and IEC and their European regional counterparts. The joint agreement between ISO and CEN is known as the “Vienna Agreement.”

  9. 9.

     The following link gives access to a database of mandates, together with the access to their full text. http://ec.europa.eu/enterprise/policies/european-standards/standardisation-requests/database-mandates/index_en.htm.

  10. 10.

    International development and voluntary national standardization – Japanese initiative – World Trade and Standardization, 27–28 September, 2001. Berlin, Germany. Akira Aoki, Council member, JISC. www.ifan.org.

  11. 11.

    The history of the ISO 9000 series dates back to Mil-Q-9858a, a United States military procurement specification established in 1959. Quality system requirements for suppliers were adopted by the US NASA (National Aeronautics and Space Administration) in 1962, and in 1965, NATO (North Atlantic Treaty Organization) accepted specifications for equipment procurement. BS5750, a voluntary standard published by the British Standards Institution (BSI) in 1979, took on quality systems for the manufacturing sector more broadly, and led to the subsequent adoption of ISO 9000 in 1988. The ISO 9000 series is now employed across a variety of types of businesses and is accepted by more than 100 countries. Peter Emerson, History of ISO 9000, http://ezinearticles.com/?History-of-ISO-9000id=352833.

  12. 12.

    International Standards and Private Standards, ISO (2010), www.iso.org/iso/private_standards.pdf, p. 7.

  13. 13.

    ISO/TR 12885:2008 Nanotechnologies – Health and safety practices in occupational settings relevant to nanotechnologies;http://www.iso.org/iso/iso_catalogue/catalogue_tc/catalogue_tc_browse.htm?commid=381983published=onincludesc=true Another document,ISO/TR 13121 Nanotechnologies Nanomaterial Risk Evaluation, is scheduled for publication in 2010.

  14. 14.

    Hiding Risks Can Hurt Public Support For Nanotechnology, Survey Finds. Science Daily. http://www.sciencedaily.com/releases/2010/05/100504095212.htm . May 4, 2010.

    In their survey, participants were segmented and given various illustrations and explanations regarding a nanoscale medical device. One set of participants was shown an unrealistic illustration meant to represent a nanoscale medical device. Another group was given the same image together with a “therapeutic” framing statement that described the technology as being able to restore an ill person to full health. A third segment was given the image, along with an “enhancement” framing statement that described the technology as being able to make humans faster, stronger and smarter. Two additional groups of survey participants were given the image, the framing statements, and information about potential health risks. The last set of participants was not given the image, a framing statement or risk information. The survey included 849 participants, with a margin of error of plus or minus 3.3%. At the end of the day, participants were generally accepting of the associated therapeutic advances expected in public health when they were given realistic and more complete information about nanotechnologies. Correspondingly, the less those surveyed knew or were told about nanotechnology, the more skeptical they became.

  15. 15.

    2007. Guidance on the labelling of manufactured nanoparticles and products containing manufactured nanoparticles.http://www.bsigroup.com/en/sectorsandservices/Forms/PAS-130/Download-PAS-130/.

  16. 16.

    Indian Head, Inc. v. Allied Tube & Conduit Corp., No. 81 Civ. 6250 (S.D.N.Y. June 27, 1986), Brief of the United States and the Federal Trade Commission, Amicus Curiae, at 7 (October 24, 1986).

  17. 17.

    http://www.wto.org/english/tratop_e/tbt_e/tbt_e.htm.

  18. 18.

    International Standards and Private Standards, ISO (2010), http://www.iso.org/iso/private_standards.pdf, p. 3.

  19. 19.

    Decision of the Committee on Principles for the Development of International Standards, Guides and Recommendations with relation to Articles 2, 5 and Annex 3 of the Agreement, Second Triennial Review of the TBT Agreement, http://docsonline.wto.org/DDFDocuments/t/G/.

  20. 20.

    75 Fed. Reg, 1024, January 8, 2010.

  21. 21.

    Comments from the European Union relating to Notification G/TBT/N/USA/499. Proposed significant new use rules on certain chemical substances, January 14, 2010.

  22. 22.

    In Canada, the National Lumber Grades Authority is responsible for writing, interpreting and maintaining Canadian lumber grading rules and standards (http://www.nlga.org/app/dynarea/view_article/1.html). In the United States, the National Hardwood Lumber Association publishes grading rules for hardwood (http://www.nhla.com/) while the American Lumber Standards Committee publishes Voluntary Product Standard 20 (PS-20) for softwood lumber (http://www.alsc.org/untreated_ps20_mod.htm). See also, Guide on Grading Malaysian Rubberwood (http://www.ehow.com/way_6190491_guideline-grading-malaysian-rubberwood.html).

  23. 23.

    Nanotechnology in Construction – one of the top ten answers to world’s biggest problems (May 3, 2005) http://www.aggregateresearch.com/article.aspx?ID=6279&archive=1 ; Nanotechnology and construction report, Nanoforum European Nanotechnology Gateway (November 2006); http://www.nanoforum.org/nf06modulshowmorefolder99999scid425.html?action=longview_publication .

  24. 24.

    http://www.israelidiamond.co.il/english/News.aspx?boneID=918objID=6997.

  25. 25.

    Stanford University, SLAC Public Lecture – Ultimate Atomic Bling: Nanotechnology of Diamonds, May 25, 2010, http://events.stanford.edu/events/238/23829/.

  26. 26.

    How to tell synthetic diamonds from natural diamonds, http://www.ehow.com/how_4833499_tell-synthetic-diamonds-natural-diamonds.html#ixzz0qpXl1mOO.

  27. 27.

    Nanotechnology cancer treatment with diamonds (November 7, 2008), http://www.nanowerk.com/spotlight/spotid=8081.php.

  28. 28.

    Researchers develop new technique simplifying production of high quality diamonds for electronics, October 28, 2008 http://www.azom.com/news.asp?newsID=14307 .

  29. 29.

    Clarence Borel v. Fibreboard Paper Products Corporation, et al. 493 F.2d 1076 (1973).

  30. 30.

    Proposed regulations eliminating this mandatory practice can be found in the September 30, 2009 Federal Register, at http://edocket.access.gpo.gov/2009/pdf/E9-22483.pdf. OSHA proposes on page 50401 to maintain the requirement to list OSHA’s mandatory permissible exposure limits (PELs) on the Safety Data Sheets and not the TLVs©.

  31. 31.

    Private Sector and International Standard-Setting: The Challenge for Business and Government, Virginia Haufler, Carnegie Discussion Paper 3, Study Group on the role of the private sector http://www.Carnegieendowment.Org/Publications/Index.Cfm?Fa=ViewId=220 .

  32. 32.

    Interim Policy Statement on Health Canada’s Working Definition for Nanomaterials (February 11, 2010) http://www.hc-sc.gc.ca/sr-sr/consult/_2010/nanomater/draft-ebauche-eng.php . New Nano Rule for EU Cosmetics November 27, 2009 http://www.rsc.org/chemistryworld/News/2009/November/27110901.asp . European Parliament approaches Nanomaterials in Electrical and Electronic Equipment with strong Language and a heavy Hand, Nanotechnology Industry Association News, April 27, 2010 http://www.nanotechia.org/news/global?page=2 ; European Commission urgently demands science-based Definition of Nanomaterials Nanotechnology Industry Association News, March 4, 2010 http://www.nanotechia.org/news/global?page=2 .

  33. 33.

    ISO TS 27687 (2008).

  34. 34.

    Ibid.

  35. 35.

    Ibid.

  36. 36.

    Standards are frequently published within 3 years of initiating the work. http://www.rlc.fao.org/en/prioridades/sanidad/normpub.htm. While the process sometimes appears ponderous and slow to those who are in the middle of it, major legislative and regulatory developments can easily take much longer.

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Bell, C., Marrapese, M. (2011). Nanotechnology Standards and International Legal Considerations. In: Murashov, V., Howard, J. (eds) Nanotechnology Standards. Nanostructure Science and Technology. Springer, New York, NY. https://doi.org/10.1007/978-1-4419-7853-0_10

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