NANOTECHNOLOGY CONSIDERATIONS FOR THE EPA AND FDA -- NANOTECHNOLOGY CONSIDERATIONS FOR THE EPA AND FDA -- CONTENTS -- PREFACE -- 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 -- 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 -- 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.