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GUIDELINES FOR THE USE AND SAFETY OF GENETIC ENGINEERING TECHNIQUES OR RECOMBINANT DNA TECHNOLOGY

Prologue

Preface

I. Introduction

II. General Aspects: Biosafety Considerations and Definitions

III. Review of Proposals and Certification of Facilities

IV. Containment Practices and Specifications

V. Planned Release

VI. Specific Aspects. Guidelines for Research Involving Recombinant DNA Molecules

Appendix A - Exemptions Under Section VI.C.4

Appendix B - Classification of Microorganisms on the Basis of Hazard

Appendix C - Exemptions Under Section VI.C.4.5

Appendix D - Physical Containment

Appendix E - Biological Containment

VII. Supplementary Guidelines

VIII. General Requirements for New Drugs and Biologics for Human Use

IX. General Requirements for Animal Food Additives and Drugs

X. General Requirements for Medical Devices

XI. General Requirements for Foods

XII. Points to Consider in Preparing Proposal for Research Involving Recombinant DNA Technology

Appendix F - Proposal Forms

Annex 1

Annex 2

1999

PDF, 146 pages, 563 Kb.

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