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Nanotechnology considerations for the EPA and FDA [electronic resource]
להגדלת הטקסט להקטנת הטקסט- ספר
| כותר |
Nanotechnology considerations for the EPA and FDA [electronic resource] / Scott J. Castiglione, editor. |
|---|---|
| מהדורה |
1st ed. |
| מוציא לאור |
Hauppauge, N.Y. : Nova Science Publishers |
| שנה |
c2011 |
| הערות |
Description based upon print version of record. Includes bibliographical references and index. English |
| הערת תוכן ותקציר |
Intro -- NANOTECHNOLOGY CONSIDERATIONS FOR THE EPA AND FDA -- NANOTECHNOLOGY CONSIDERATIONS FOR THE EPA AND FDA -- CONTENTS -- PREFACE -- Chapter 1 NANOTECHNOLOGY: NANOMATERIALS ARE WIDELY USED IN COMMERCE, BUT EPA FACES CHALLENGES IN REGULATING RISK -- WHY GAO DID THIS STUDY -- WHAT GAO RECOMMENDS -- WHAT GAO FOUND -- ABBREVIATIONS -- BACKGROUND -- NANOMATERIALS CURRENTLY ENHANCE PRODUCTS ACROSS A NUMBER OF INDUSTRY SECTORS, AND NEW USES CONTINUE TO BE DEVELOPED -- Automotive -- Defense and Aerospace -- Electronics and Computers -- Energy and Environment -- Food and Agriculture -- Housing and Construction -- Personal Care, Cosmetics, and Other Consumer Products -- POTENTIAL RISKS TO HUMAN HEALTH AND THE ENVIRONMENT FROM NANOMATERIALS DEPEND ON TOXICITY AND EXPOSURE, AND CURRENT UNDERSTANDING OF THE RISKS IS LIMITED -- The Toxicity of Individual Nanomaterials May Vary According to Their Properties and Affects Their Risks -- Risk of Nanomaterials Is Also Affected by the Route and Extent of Exposure -- Understanding of the Risks Posed by Nanomaterials Is Limited by Several Factors -- EPA HAS TAKEN A MULTIPRONGED APPROACH TO MANAGING THE POTENTIAL RISKS OF NANOMATERIALS BUT FACES VARIOUS CHALLENGES IN REGULATING THESE MATERIALS -- EPA Has Ongoing Research Efforts Related to Nanomaterials -- Under TSCA, EPA Has Regulated Some Nanomaterials as New Chemicals or New Uses, but Some Nanomaterials May Be Entering the Market without EPA Review -- EPA Has Not Developed a Clear Process under FIFRA for Regulating Pesticides Containing Nanomaterials -- EPA Believes It Has the Authority to Regulate Nanomaterials under Air, Water, and Waste Statutes but Technology-related Limitations and Volume-based Regulatory Thresholds Present Regulatory Challenges. OTHER NATIONAL AUTHORITIES ARE COLLECTING INFORMATION ON NANOMATERIALS AND ARE EVALUATING THEIR LEGISLATION TO ASCERTAIN IF CHANGES ARE NEEDED -- Australia Has Asked Companies to Voluntarily Provide Information on Nanomaterials and Is Currently Reviewing Comments on Proposed Legislative and Regulatory Changes -- The United Kingdom Has Asked Companies to Voluntarily Report Certain Data on Nanomaterials and Is Currently Reviewing Whether Legislative Changes Are Needed -- Canada Is Drafting a Requirement That Companies Provide Information on Nanomaterials and Plans to Review the Data Collected before Proposing Any Regulatory Changes -- The European Union Is Considering Revising Its Chemicals Legislation to Better Address Nanomaterials, and Is Requiring Labeling of Nanomaterials in Certain Products -- SOME STATE AND LOCAL GOVERNMENTS HAVE BEGUN TO ADDRESS THE RISKS OF NANOMATERIALS -- CONCLUSIONS -- RECOMMENDATIONS FOR EXECUTIVE ACTION -- APPENDIX I: OBJECTIVES, SCOPE, AND METHODOLOGY -- APPENDIX II: COMMENTS FROM THE ENVIRONMENTAL PROTECTION AGENCY -- RELATED GAO REPORTS -- End Notes -- Chapter 2 NANOTECHNOLOGY AND ENVIRONMENTAL, HEALTH, AND SAFETY: ISSUES FOR CONSIDERATION -- SUMMARY -- INTRODUCTION -- OPPORTUNITIES AND CHALLENGES -- IMPORTANCE OF ADDRESSING EHS ISSUES -- SELECTED ISSUES FOR CONSIDERATION -- Federal Investment in EHS Research -- Current Funding Level -- Alternative Approaches -- Management of Federal EHS Research -- Federal Regulation -- International Engagement -- Concluding Observations -- NANOTECHNOLOGY EHS-RELATED LEGISLATION IN THE 111TH CONGRESS -- H.R. 554-National Nanotechnology Initiative Amendments Act of 2009 -- H.R. 820-Nanotechnology Advancement and New Opportunities Act -- APPENDIX A. SELECTED NANOTECHNOLOGY EHS ACTIVITIES OF FEDERAL REGULATORY AGENCIES -- Environmental Protection Agency -- Food and Drug Administration. National Institute of Environmental Health Sciences/National Toxicology Program -- Occupational Safety and Health Administration/National Institute for Occupational Safety and Health -- Consumer Product Safety Commission -- APPENDIX B. SELECTED INTERNATIONAL ENGAGEMENT EFFORTS OF NNI AGENCIES -- End Notes -- Chapter 3 NANOTECHNOLOGY: A REPORT OF THE U.S. FOOD AND DRUG ADMINISTRATION -- EXECUTIVE SUMMARY -- INTRODUCTION -- Task Force Mission -- Definitions for Nanotechnology and Related Terms -- Organization of this Report -- STATE OF THE SCIENCE OF NANOTECHNOLOGY RELEVANT TO FDA -- Generalizable Knowledge of Biological Interactions -- Predictability of Biological Interactions -- Science Issues -- Introduction -- Issue: Understanding Interactions of Nanoscale Materials with Biological Systems -- Comments -- Analysis -- Issues Relevant to all Regulated Products -- Products Subject to Premarket Authorization -- Products Not Subject to Premarket Authorization -- Recommendations for Consideration -- Issue: Adequacy of Testing Approaches for Assessing Safety and Quality of Products Containing Nanoscale Materials -- Comments -- Analysis -- Assays to Develop Biological Effects Data -- Metrology - Characterization of Particles in the Nanoscale Range -- Inspection -- Standardization of Tests and Data Reporting -- Recommendations for Consideration -- REGULATORY POLICY ISSUES -- Background -- Discussion -- Summary of Agency Oversight Authorities by Product Type -- New Drugs and Biological Drug Products -- OTC Monograph Drugs -- New Animal Drugs and Animal Feed Containing a New Animal Drug -- Devices -- Food Additives and GRAS Food Ingredients -- Color Additives -- Cosmetics -- Dietary Supplements -- Labeling and Advertising Claims for Conventional Foods and Dietary Supplements. ISSUE: ABILITY OF FDA TO IDENTIFY FDA-REGULATED PRODUCTS THAT CONTAIN NANOSCALE MATERIALS -- Comments -- Analysis -- Recommendations for Consideration -- Issue: Scope of FDA's Authority Regarding Evaluation of Safety and Effectiveness -- Comments -- Analysis -- Products Subject to Premarket Authorization -- Recommendations for Consideration -- Products Not Subject to Premarket Authorization -- Recommendations for Consideration -- Issue: Permissible and Mandatory Labeling -- Comments -- Analysis -- Recommendations for Consideration -- Issue: National Environmental Policy Act -- Comments -- Analysis -- Recommendations for Consideration -- End Notes -- CHAPTER SOURCES -- INDEX -- Blank Page. |
| סדרה |
Nanotechnology science and technology. |
| היקף החומר |
1 online resource (175 p.) |
| שפה |
אנגלית |
| מספר מערכת |
997010705874905171 |
תצוגת MARC
תגיות
- Nanoparticles Environmental aspects.
- Nanoparticles Toxicology.
- Nanostructured materials Environmental aspects.
- Nanostructured materials Health aspects.
- Nanotechnology Environmental aspects.
- Nanotechnology Health aspects.
- Nanotechnology Government policy United States.
- Molecular technology
- Nanoscale technology
- Nanomaterials
- Nanometer materials
- Nanophase materials
- Nanostructure controlled materials
- nne Nanostructure materials
- Ultra-fine microstructure materials
- Nano-particles
- NPs (Nanoparticles)
- Nanoscale particles
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