Premanufacture Notification Chemistry

The first and only guidance document to help applicants from chemical manufacturers obtain approval to synthesize and manufacture a chemical compound. Written by two EPA scientists, it provides coverage of chemical information needed for risk assessment to satisfy the requirements of the PMN review process and comply with the Toxic Substance Control Act.

STEPHEN C. DEVITO, PhD, and CAROL A. FARRIS, PhD, are chemists with the Industrial Chemistry Branch of the Office of Pollution Prevention and Toxics at the U.S. Environmental Protection Agency.

PREFACE

1

(2)

LIST OF TABLES

3

(1)

LIST OF FIGURES

4

(1)

THE PREMANUFACTURE NOTIFICATION (PMN) REVIEW PROCESS

5

(39)

1.1 Introduction

5

(1)

1.2 The PMN Review Process

6

(6)

1.2.1 Receipt of the PMN

11

(1)

1.3 Chemistry Review Phase

12

(15)

1.3.1 Initial Chemistry Review

13

(2)

1.3.2 Inventory Review

15

(1)

1.3.3 Preparation of the Chemistry Report

16

(8)

1.3.4 Chemical Review and Search Strategy (CRSS) Meeting

24

(3)

1.4 Hazard Evaluation

27

(6)

1.4.1 Human and Ecological Hazard Identification

27

(4)

1.4.2 Environmental Fate

31

(1)

1.4.3 Structure-Activity Team Meeting

32

(1)

1.5 Exposure Evaluation

33

(2)

1.6 Risk Assessment/Risk Management Phase

35

(5)

1.6.1 Focus Meeting

35

(3)

1.6.2 Standard Review

38

(2)

References for Chapter 1

40

(2)

List of Selected Readings for Chapter 1

42

(2)

CHEMICAL INFORMATION NEEDED FOR RISK ASSESSMENT

44

(51)

2.1 Introduction

44

(1)

2.2 Important Chemical Information

45

(29)

2.2.1 Melting Point

45

(4)

2.2.2 Octanol/Water Partition Coefficient (Kow,P)

49

(10)

2.2.3 Water Solubility

59

(3)

2.2.4 Soil/Sediment Adsorption Coefficient

62

(1)

2.2.5 Henry's Law Constant

63

(2)

2.2.6 Boiling Point

65

(1)

2.2.7 Vapor Pressure

66

(2)

2.2.8 Reactivity

68

(1)

2.2.9 Hydrolysis

69

(1)

2.2.10 Spectral Data

70

(1)

2.2.11 Photolysis (Direct/Indirect)

70

(2)

2.2.12 Other Chemical Information

72

(2)

2.3 Use of Chemical Information in Assessment of PMN Chemicals

74

(1)

2.4 How EPA Obtains Physicochemical Information

74

(9)

2.4.1 General Approach

74

(4)

2.4.2 Methods of Searching for Measured Physicochemical Properties

78

(2)

2.4.3 Methods For Estimating Physicochemical Properties From Structural Analogs

80

(1)

2.4.4 Methods For Estimating Physicochemical Properties Using Computer Estimation Programs

81

(2)

References for Chapter 2

83

(7)

List of Selected Readings for Chapter 2

90

(5)

POLLUTION PREVENTION AND PREMANUFACTURE NOTIFICATIONS

95

(10)

3.1 Introduction: Pollution Prevention

95

(2)

3.2 Pollution Prevention Initiatives within EPA's PMN Program

97

(1)

3.2.1 Optional Pollution Prevention Information (page 11 of the PMN form)

97

(1)

3.2.2 Synthetic Method Assessment for Reduction Techniques (SMART) Review

98

(2)

3.3 Considerations in Implementing Pollution Prevention Practices Prior to Submission of PMN Substances

100

(3)

References for Chapter 3

103

(1)

List of Selected Readings for Chapter 3

104

(1)

THE TOXIC SUBSTANCES CONTROL ACT: HISTORY AND IMPLEMENTATION

105

(27)

A.1 Introduction

105

(3)

A.2 The Premanufacture Provisions of TSCA

108

(6)

A.2.1 Definition of "Chemical Substance" Under TSCA

109

(1)

A.2.2 Definition of "New" Chemical Substance

109

(1)

A.2.3 Section 5: Manufacturing and Processing Notices

109

(3)

A.2.4 Other Sections of TSCA Related to Section 5

112

(2)

A.2.4.1 Section 4. Testing of Chemical Substances and Mixtures

112

(1)

A.2.4.2 Section 6. Regulation of Hazardous Chemical Substances and Mixtures

112

(1)

A.2.4.3 Section 7. Imminent Hazards

113

(1)

A.2.4.4 Section 8. Reporting and Retention of Information

113

(1)

A.2.4.5 Section 12. Exports

113

(1)

A.2.4.6 Section 13. Entry into Customs Territory of the United States

113

(1)

A.2.4.7 Section 14. Disclosure of Data

114

(1)

A.3 Implementation of TSCA

114

(10)

A.3.1 The TSCA Inventory

114

(2)

A.3.2 Inventory Update Rule

116

(1)

A.3.3 Premanufacture Notification Rule and Form

116

(1)

A.3.4 Biotechnology

117

(1)

A.3.5 Exemptions

117

(3)

A.3.5.1 Test Market Exemptions

117

(1)

A.3.5.2 5(h)(3) Exemption for Research and Development

118

(1)

A.3.5.3 5(h)(4) Exemptions

118

(1)

A.3.5.4 Instant Film Exemption

118

(1)

A.3.5.5 Low Volume Exemption

118

(1)

A.3.5.6 Low Release and Exposure Exemption

119

(1)

A.3.5.7 Polymer Exemption

119

(1)

A.3.6 TSCA Section 5(e) Consent Orders and Significant New Use Rules

120

(4)

A.3.7 Polymers: The Two Percent Rule

121

(1)

A.3.8 Importing Chemical Substances

121

(1)

A.3.9 Addendum to Appendix: Inventory Reporting Regulations

121

(3)

References for Appendix

124

(5)

List of Selected Readings for Appendix

129

(3)

Index

132

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Premanufacture Notification Chemistry Assistance for Submitters

Summary

Author Biography

Table of Contents

Supplemental Materials

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Premanufacture Notification Chemistry Assistance for Submitters

Summary

Author Biography

Table of Contents

Supplemental Materials

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