EPA Office of Compliance Sector Notebook Project: Profile of the

0,68

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Pharmaceutical Manufacturing Industry

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5898

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UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

1998

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Table of Contents

List of Tables vii

List of Figures viii

List of Acronyms . ix

I. INTRODUCTION TO THE SECTOR NOTEBOOK PROJECT 1

A. Summary of the Sector Notebook Project . 1

B. Additional Information . 2

II. INTRODUCTION TO THE PHARMACEUTICAL INDUSTRY . 3

A. Introduction, Background, and Scope of the Notebook . 3

B. Characterization of the Pharmaceutical Industry . 3

1. Product Characterization 5

2. Industry Size . 6

3. Geographic Distribution 11

4. Economic Trends and International Competition 13

III. INDUSTRIAL PROCESS DESCRIPTION 17

A. Industrial Processes in the Pharmaceutical Industry . 17

1. Research and Development . 17

2. Production of Bulk Pharmaceutical Substances 19

3. Formulation, Mixing, and Compounding . 32

B. Raw Material Inputs and Pollutant Outputs . 38

1. Raw Materials . 40

2. Air Emissions and Control Systems 43

3. Wastewater . 46

4. Solid Wastes . 50

C. Management of TRI Chemicals in the Production Process 51

IV. CHEMICAL RELEASE AND TRANSFER PROFILE . 53

A. EPA Toxic Release Inventory for the Pharmaceutical Industry . 57

B. Summary of Selected Chemicals Released 68

C. Other Data Sources . 72

D. Comparison of Toxic Release Inventory Among Selected Industries 74

V. POLLUTION PREVENTION OPPORTUNITIES . 77

A. Material Substitutions . 79

B. Process Modifications . 83

C. Good Operating Practices 87

D. Recycling, Recovery, and Reuse . 90

E. Pollution Prevention Research . 92

VI. SUMMARY OF APPLICABLE FEDERAL STATUTES AND REGULATIONS 93

A. General Description of Major Statutes . 93

B. Industry Specific Requirements . 105

C. Pending and Proposed Regulatory Requirements 110

D. Other Federal Regulations Affecting the Pharmaceutical Industry . 111

E. Other Statutes and Regulations Affecting the Pharmaceutical Industry 114

VII. COMPLIANCE AND ENFORCEMENT HISTORY . 117

A. Pharmaceutical Industry Compliance History . 121

B. Comparison of Enforcement Activity Between Selected Industries . 123

C. Review of Major Legal Actions . 128

1. Review of Major Cases 128

2. Supplementary Environmental Projects (SEPs) 129

VIII. COMPLIANCE ACTIVITIES AND INITIATIVES . 131

A. Sector-related Programs and Activities . 131

B. EPA Voluntary Programs . 131

C. Trade Association/Industry Sponsored Activity . 138

1. Environmental Programs . 138

2. Summary of Trade Associations . 140

IX. CONTACTS/ACKNOWLEDGMENTS/REFERENCES . 143