Assists policymakers in evaluating the appropriate scientific methods for detecting unintended changes in food and assessing the potential for adverse health effects from genetically modified products. In this book, the committee recommended that greater scrutiny should be given to foods containing new compounds or unusual amounts of naturally occurring substances, regardless of the method used to create them.

The book offers a framework to guide federal agencies in selecting the route of safety assessment. It identifies and recommends several pre- and post-market approaches to guide the assessment of unintended compositional changes that could result from genetically modified foods and research avenues to fill the knowledge gaps.

Contents

• THE NATIONAL ACADEMIES
• COMMITTEE ON IDENTIFYING AND ASSESSING UNINTENDED EFFECTS OF GENETICALLY ENGINEERED FOODS ON HUMAN HEALTH
• COMMITTEE ON AGRICULTURAL BIOTECHNOLOGY, HEALTH, AND THE ENVIRONMENT
• BOARD ON LIFE SCIENCES
• FOOD AND NUTRITION BOARD
• BOARD ON AGRICULTURE AND NATURAL RESOURCES
• Preface
• Reviewers
• Executive Summary
• 1. Introduction
  • HISTORICAL BACKGROUND
  • GENETIC MODIFICATION OF FOOD
  • THE CHARGE TO THE COMMITTEE
  • REFERENCES
• 2. Methods and Mechanisms for Genetic Manipulation of Plants, Animals, and Microorganisms
  • BACKGROUND
  • PLANT GENETIC MODIFICATION
  • ANIMAL GENETIC MODIFICATION
  • GENETIC MODIFICATION OF MICROBES
  • REFERENCES
• 3. Unintended Effects from Breeding
  • BACKGROUND
  • PLANT BREEDING
  • ANIMAL BREEDING
  • MECHANISMS BY WHICH UNINTENDED EFFECTS IN GENETICALLY ENGINEERED ORGANISMS ARISE
  • THE GENETIC MANIPULATION CONTINUUM
  • DISCUSSION
  • REFERENCES
• 4. New Approaches for Identifying Unintended Changes in Food Composition
  • BACKGROUND
  • TARGETED QUANTITATIVE ANALYSIS VERSUS PROFILING METHODS
  • NONTARGETED ANALYTICAL METHODS FOR METABOLITES
  • BIOINFORMATIC ISSUES IN PROFILING ANALYSIS
  • PROFILING METHODS FOR ANALYSIS OF INORGANIC ELEMENTS OF NUTRITIONAL AND TOXICOLOGICAL IMPORTANCE
  • GENOMICS
  • PROTEOMICS
  • INFORMATION OBTAINED FROM NEW ANALYTICAL TECHNIQUES
  • DISCUSSION
  • REFERENCES
• 5. Adverse Impacts of Food on Human Health
  • INTRODUCTION
  • FOOD SAFETY HAZARDS IN FOOD PRODUCTS
  • SAFETY HAZARDS IN FOOD PRODUCTS ASSOCIATED WITH GENETIC MODIFICATION
  • REFERENCES
• 6. Methods for Predicting and Assessing Unintended Effects on Human Health
  • BACKGROUND
  • STAGES IN THE DEVLOPMENT OF GE FOODS
  • SUBSTANTIAL EQUIVALENCE AND ITS ROLE IN SAFETY ASSESSMENT
  • CURRENT SAFETY STANDARDS FOR GE FOODS
  • SAFETY ASSESSMENT PRIOR TO COMMERCIALIZATION
  • APPLICATION, VALIDATION, AND LIMITATIONS OF TOOLS FOR IDENTIFYING AND PREDICTING UNINTENDED EFFECTS
  • EVALUATION OF POSSIBLE UNINTENDED CONSEQUENCES OF INSERTED GENES
  • TOOLS FOR PREDICTING AND ASSESSING UNINTENDED EFFECTS
  • NEED FOR CLINICAL AND EPIDEMIOLOGICAL STUDIES
  • DISCUSSION
  • REFERENCES
• 7. Framework, Findings, and Recommendations
  • BACKGROUND
  • FRAMEWORK FOR ASSESSING POTENTIAL UNINTENDED EFFECTS
  • FINDINGS AND RECOMMENDATIONS
  • CONCLUDING REMARKS
• Appendixes
  • A Glossary
  • B Open Session and Workshop Agendas
  • C Committee Member Biographical Sketches
• Subreport Methods and Mechanisms of Genetic Manipulation and Cloning of Animals

Support for this project was provided by the U.S. Department of Health and Human Services Food and Drug Administration under contract number 223-93-1025, the U.S. Department of Agriculture under contract number 59-0790-1-183, and the U.S. Environmental Protection Agency under contract number X-82956001. The views presented in this report are those of the Committee on Identifying and Assessing Unintended Effects of Genetically Engineered Foods on Human Health and are not necessarily those of the funding agencies.

NOTICE: The project that is the subject of this report was approved by the Governing Board of the National Research Council, whose members are drawn from the councils of the National Academy of Sciences, the National Academy of Engineering, and the Institute of Medicine. The members of the committee responsible for the report were chosen for their special competences and with regard for appropriate balance.