By David Naidu
This booklet analyzes law governing biotechnology and nanotechnology industries. rules of biotechnology, which typically encompasses the manipulation of residing fabrics through passing genetic details from one organism to a different, emerged within the 1970's and is of significant drawback to the scientific, pharmaceutical, chemical production, and agricultural fields. Nanotechnology, which refers back to the layout and creation of molecular-sized units and items, is a newer box whose legislation has an effect at the comparable industries as biotechnology and likewise impacts semiconductors, communications expertise, cosmetics, and customer items. extra law is probably going as the want for wisdom of the dangers focused on procedures and items is expanding. either fields are topic to a similar regulatory schemes, and this ebook describes the applying of significant legislation, resembling the Federal foodstuff, Drug, and beauty Act, the fresh Water Act, and the fresh Air Act, to every phase of the biotechnology nanotechnology undefined. additionally mentioned are overseas matters and ongoing improvement of rules governing those fields.
record of Acronyms
desk of Contents
1. advent to legislation of Biotechnology and Nanotechnology
2. what's Biotechnology? what's Nanotechnology?
three. knowing the hazards from Nanotechnology and Biotechnology
four. production of a Regulatory constitution
five. rules of Transgenic crops and Animals
6. rules of nutrition
7. medicinal drugs, Biologics, and clinical units
nine. client items
10. chemical substances
eleven. Evolution of Biotechnology legislation and the way forward for Nanotechnology legislation
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Additional resources for Biotechnology and Nanotechnology - Regulation under Environmental, Health, and Safety Laws
See Chapter 10 on TSCA. A summary of some of that data is found in Richard Denison’s blog on nanotechnology. See R. org. 27. See NNI, Environmental, Health and Safety Research Needs for Engineered Nanoscale Materials (September 2006) at 20. 28. , SMALL SIZES THAT MATTER: OPPORTUNITIES AND RISKS OF NANOTECHNOLOGIES 30 (2005). 29. S. Environmental Protection Agency, Nanotechnology White Paper, EPA 100/ B-07/001 (February 2007) at 54. [hereinafter EPA White Paper]. 30. National Nanotechnology Initiative, Environmental, Health and Safety Research Needs for Engineered Nanoscale Materials (September 2006) at 20.
37 And, what would happen if under real world conditions the coating was removed due to interaction with the environment? 31. Oberdorster, supra note 30, at 9. 32. See id. Linda-Jo Schierow, CRS Report for Congress: Engineered Nanoscale Materials and Derivative Products: Regulatory Challenges (Jan. 22, 2008) at CRS-7; International Center for Technology Assessment, Petition for Rulemaking Requesting EPA Regulate NanoSilver as Pesticides (February 2008) at 61. 33. S. House of Representatives, Committee on Science, Environmental and Safety Impacts of Nanotechnology; What Research is Needed?
FDA/CFSAN, supra note 40. Efforts have been taken to use marker genes that are widespread in nature with the corresponding antibiotics either being seldom used or not used at all. See id. However, until transgenic plants can be developed without the use of antibiotic-resistant marker genes, it will still be necessary to examine the potential impacts to the human digestive system. 93. Oberdorster, supra note 30, at 28. 94. NNI Nanoscale Research Needs, supra note 76, at 26. 95. See USDA Introduction of GEOs, supra note 42, at 67–68.