Biomedical Engineering Reference
In-Depth Information
15
Regulatory Implications
of Nanotechnology
Lynn L. Bergeson and Michael F. Cole
CONTENTS
15.1 Introduction ........................................................................................................................ 315
15.2 The Beginnings of Regulation ........................................................................................... 315
15.3 Regulatory Challenges ....................................................................................................... 316
15.4 Lack of Reliable Data ......................................................................................................... 318
15.5 Lack of Reliable Tools ........................................................................................................ 318
15.6 U.S. Food and Drug Administration .................................................................................. 320
15.7 U.S. Environmental Protection Agency ............................................................................. 326
15.8 Work Place Concerns ......................................................................................................... 329
15.9 The European Union .......................................................................................................... 330
15.9.1 Cosmetic Directive ................................................................................................ 333
15.9.2 Food Labeling ....................................................................................................... 334
15.9.3 Medical Device and Pharmaceutical .................................................................... 335
15.10 Nanomaterials in Products ................................................................................................. 336
15.10.1 Classification, Labeling, and Packaging ............................................................... 336
15.11 Other Countries .................................................................................................................. 338
15.11.1 Germany ................................................................................................................ 338
15.11.2 United Kingdom .................................................................................................... 340
15.11.3 France .................................................................................................................... 341
15.11.4 Denmark ................................................................................................................ 341
15.11.5 Netherlands ........................................................................................................... 342
15.11.6 Australia ................................................................................................................ 342
15.11.7 Canada ...................................................................................................................344
15.12 Conclusion .......................................................................................................................... 345
15.1 INTRODUCTION
This chapter examines the effect regulation, albeit nascent, is having or may have on the com-
mercialization of nanomaterials in the pharmaceutical and medical fields in the United States and
abroad. It will also discuss how authorities are addressing the effects the application of nanotechnol-
ogy are believed to be having on the environment. It will examine the types of regulatory schemes
being enacted or considered, and whether different systems are likely to have differing effects on
nanomedicine, including the effect on competition among companies and countries.
15.2 THE BEGINNINGS OF REGULATION
In recent years, there has been an increase in the incorporation of nanomaterials in products and com-
ponents utilized in the pharmaceutical and medical fields. There are a number of products containing
nanomaterials already in commercial distribution and many more in the development and concept
315
