Nanotechnology considerations for the EPA and FDA / Scott J. Castiglione, editor.

Format:

Book

Contributor:

Castiglione, Scott J.

Series:

Nanotechnology science and technology series.

Nanotechnology science and technology.

Language:

English

Subjects (All):

Nanoparticles--Environmental aspects.

Nanoparticles.

Nanoparticles--Toxicology.

Nanostructured materials--Environmental aspects.

Nanostructured materials.

Nanostructured materials--Health aspects.

Nanotechnology--Environmental aspects.

Nanotechnology.

Nanotechnology--Health aspects.

Nanotechnology--Government policy--United States.

Physical Description:

1 online resource (175 p.)

Edition:

1st ed.

Place of Publication:

Hauppauge, N.Y. : Nova Science Publishers, c2011.

Language Note:

English

Summary:

Nanotechnology, a term encompassing nanoscale science, engineering and technology, is focused on understanding, controlling and exploiting the unique properties of matter than can emerge at scales of 1 to 100 nanometers. This title explores the nanotechnology considerations facing the EPA and FDA today.

Contents:

Intro

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

Chapter 3 NANOTECHNOLOGY: A REPORT OF THE U.S. FOOD AND DRUG ADMINISTRATION

EXECUTIVE SUMMARY

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

Assays to Develop Biological Effects Data

Metrology - Characterization of Particles in the Nanoscale Range

Inspection

Standardization of Tests and Data Reporting

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

Issue: Scope of FDA's Authority Regarding Evaluation of Safety and Effectiveness

Issue: Permissible and Mandatory Labeling

Issue: National Environmental Policy Act

CHAPTER SOURCES

INDEX

Blank Page.

Notes:

Description based upon print version of record.

Includes bibliographical references and index.

Description based on print version record; title from PDF title page, viewed (06/30/2020).

ISBN:

1-61122-122-6

OCLC:

923659442