Premanufacture Notification Chemistry Assistance for Submitters

by Devito, Stephen C.; Farris, Carol A.

• ISBN13: 9780471191513
• ISBN10: 0471191515
• Edition: 1st
• Format: Hardcover
• Copyright: 1997-04-11
• Publisher: Wiley-Interscience

Summary

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.

Author Biography

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.

Table of Contents

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