Table Of Content

TOXIC ISSN0 1993178 SUBSTANCES JOURNAL TOXIC SUBSTANCES JOURNAL EDITOR-IN-CHIEF ASSISTANT TO THE EDITOR . Domingue Debbie Kuter og al aoe P RD3, Clearview Circle, Box 295D Hopewell Junction, NY 12533 Wilton, CT 06897 (203) 762-7942 CONTRIBUTING EDITORS A. Karim Ahmed Sam Gusman Natural Resources Defense Council The Conservation Foundation New York, NY Washington, DC Seymour L. Friess Edward H. Ziegler, Jr. Drill, Friess, Hayes, Loomis & Shafer, Inc. Northern Kentucky University Arlington, VA Highland Heights, KY EDITORIAL BOARD John D. Behun Taylor W. Hanavan Ronald A. Lang Mobil Oil Corporation Connolly, Bove & Lodge Synthetic Organic Chemical New York, NY Washington, DC Manufacturers Association J. Clarence Davies Fred D. Hoerger Washington, DC The Conservation Foundation The Dow Chemical Company Robert Polack Washington, DC Midland, MI Reilly Industries, Inc. Charles Ganz Steven Jellineck Indianapolis, IN EN-CAS Analytical Jellineck, Schwartz, Connolly Sarah Shapley Laboratories & Freshman U.S. Environmental Winston-Salem, NC Wilmington, DE Protection Agency Washington, DC Editorial Office: George S. Dominguez, 26 Cavalry Hill Road, Wilton, CT 06897. Publishing, Advertising, and Production Offices: Hemisphere Publishing Corp., 1101 Vermont Ave., Suite 200, Washington, DC 20005, phone (202)289-2174, fax (202)289-3665, Lisa Speckhardt, Production Edi- tor; or Taylor & Francis Ltd., Rankine Rd., Basingstoke, Hampshire RG24 OPR, UK. Subscriptions Office: 1900 Frost Rd., Suite 101, Bristol, PA 19007, phone (215)785-5800, fax (215)785-5515; or Taylor & Francis Ltd., Rankine Rd., Basingstoke, Hampshire RG24 OPR, UK, phone + 44-256-840366, fax +44-256-479438. Toxic Substances Journal (ISSN 0199-3178) is published quarterly by Taylor & Francis Ltd., 4 John Street, London WCIN 2ET, UK, for Hemisphere Publishing Corporation. Annual 1991 institutional subscription £76, US $132. Personal subscription rate UK £38, US $65; available to home address only, and must be paid for by personal check or credit card. Second-class postage pending at Jamaica, NY 11431. U.S. Postmaster: Send address changes to Toxic Sub- stances Journal, Publications Expediting Inc., 200 Meacham Avenue, Elmont, NY 11003. Dollar rates apply to subscribers in all countries except the UK and the Republic of Ireland, where the sterling price applies. All subscriptions are payable in advance and all rates include postage. Subscriptions are entered on an annual basis, i.e., January to December. Payment may be made by sterling check, dollar check, international money order, National Giro, or credit card (AMEX, VISA, Mastercard/Access). Orders originating in the following territories should be sent directly to: Australia—R. Hill & Son, Ltd., Suite 2, 119 Gardenvale Road, Gardenvale, Victoria, Australia 3185. India—Universal Subscription Agency Pvt. Ltd., 101-102 Community Centre, Malviya Nagar Extn., Post Bag No. 8, Saket, New Delhi. Japan— Kinokuniya Company Ltd., Journal Department, P.O. Box 55, Chitose, Tokyo 156. New Zealand—R. Hill & Son, Ltd., Private Bag, Newmarket, Auckland 1. USA, Canada, and Mexico—Taylor & Francis, Inc./ Hemisphere Publishing Corporation, 1900 Frost Road, Suite 101, Bristol, PA 19007, USA. UK and all other territories—Taylor & Francis, Ltd., Rankine Road, Basingstoke, Hampshire RG24 OPR, England. Copyright © 1991 by Hemisphere Publishing Corporation. All rights reserved. Printed in the United States of America. Authorization to photocopy items for internal or personal use, or the internal or personal use of specific clients, is granted by Hemisphere Publishing Corporation for libraries and other users registered with the Copyright Clearance Center (CCC) Transactional Reporting Service, provided that the base fee of $3.00 per copy, plus .00 per page is paid directly to CCC, 27 Congress St., Salem, MA 01970, USA. The publisher assumes no responsibility for any statements of fact or opinion expressed in the published papers or in the advertisements. Toxic Substances Journal is owned by Hemisphere Publishing Corporation. The paper in this publication meets the requirements of the ANSI Standard Z39.48-1984(Permanence of Paper), effective with Volume 11, Number 2, 1991. CONTENTS OF VOLUME 11 Number 1 Modeling of Combined Toxic Effects of Chemicals Erik R. Christensen and Chung-Yuan Chen Terrestrial Microcosms for Evaluating the Environmental Fate and Risks Associated with the Release of Chemicals or Genetically Engineered Microorganisms to the Environment J. K. Fredrickson, R Van Voris, S. A. Bentjen, and H. Bolton, Jr. Number 2 Role of Chemical Delivery Modes in Toxicological Studies Steven R. Patierno Approaches to Identifying, Characterizing, and Managing Risks from Accidentally Released Toxic Gases P. D. Moskowitz and V. M. Fthenakis Polychlorinated Dibenzofurans: Environmental Impact, Toxicology, and Risk Assessment Stephen Safe Number 3 Editorial Guest Editorial TSCA Section 8(e) Reporting Guide What is the Statutory Language of TSCA Section 8(e)? Why is Section 8(e) Reporting Important? How was EPA's Section 8(e) Policy Statement Developed? What is ‘’Substantial Risk’ Information? Who is Subject to Section 8(e) Reporting? What Chemicals are Subject to Section 8(e) Reporting? What Does the Term ‘Obtains Information’’ Mean? What are the Sources of 8(e)-Reportable Information? What Information is Not Reportable Under Section 8(e)? How Does 8(e) Relate to Section 4, 5 & 8(d) Reporting? Does a “For Your Information’’ Submission Satisfy 8(e) Requirements? Does Reporting to Another Agency Satisfy 8(e)? Requirements When Must Section 8(e) Information be Reported? Where Must Section 8(e) Information be Reported? How Must Section 8(e) Information be Reported? How Can Confidential Data be Claimed/Sent Under Section 8(e)? How Does EPA Identify/Track Incoming Section 8(e) Notices? TSCA Section 8(e) Reporting Guide (cont.) How Does OTS Review/Use Section 8(e) Information? Do Status Reports Represent EPA’s Bottom-Line Regarding Risk? Has EPA Issued Other Section 8(e) Guidance-Related Information? How Can the Public Obtain Section 8(e) Submissions? Is There a Section 8(e) Enforcement Response Policy? Has EPA Taken Formal Section 8(e) Enforcement Actions? Does EPA 8(e) Implementation Encourage Pollution Prevention? TSCA Section 8(e) Reportability of Toxicologic Case Studies A. Numerical Reporting Guidance for Lethality Information B. Acute Toxicity Tests with Non-Lethal Neurobehavioral Findings C. Skin/Eye Irritation and Skin Sensitization Tests D. Subchronic Toxicity APPENDIX A: Index of 8(e) Status Reports Containing Policy/Guidance |. Toxicological/Exposure Findings . Acute Toxicity (Animal) Acute Toxicity (Human) . Subacute Toxicity (Animal) . Immunotoxicity (Animal) Neurotoxicity (Animal) Neurotoxicity (Human) . Oncogenicity (Animal) . Oncogenicity (Human) Reproductive/Developmental Toxicity (Animal) Reproductive/Developmental Toxicity (Human) Genotoxicity (In vitro) Genotoxicity (In vivo) . Aquatic Toxicity/Bioconcentration ZmSo. rnEmAwe~pragyecpnr cyT rIoncainde nts of Environmental Contamination Oo . General (Nonemergency) Environmental Contamination . General Reporting Issues a . Intracorporate Reporting Procedures B. Subject Persons C . Subject Chemicals D . Research & Development Chemicals = Drug Report F. Pesticide Export G . Previous Manufacture/Import/Process/ Distribution H . Obtaining Information I. Pre-1977 Information J. Actual Knowledge by EPA K. Published Scientific Literature b. Information Obtained from Other Federal Agencies M . Information Corroborating Well-Established Effects N . Relationship to Other TSCA Reporting Requirements . Relationship to Other EPA Administered Authorities 00 Relationship to Authorities Not Administered by EPA O . Section 8(e) Reporting Procedures APPENDIX B: Index of All Section 8(e) Status Reports Arranged by Submitted Information Type APPENDIX C: TSCA Section 8(e) Policy Statement (March 16, 1978; 43 FR 11110) APPENDIX D1: TSCA Section 8(e) Compliance Audit Program Notice (February 1, 1991; 56 FR 4128) APPENDIX D2: Compliance Audit Program Modification Notice (April 26, 1991; 56 FR 19514) APPENDIX D3: Compliance Audit Program Modification Notice (encoded version June 20, 1991; 56 FR Part IV) APPENDIX E: Support Information for Confidentiality Claims Number 4 Molecular Mechanism of Action of Dioxin—Implications on Its Carcinogenic Potency Estimation Venkateswara R. Rao The Toxic Substances Control Act Richard deC. Hinds Risk Procedures George S. Dominguez Animals and Alternatives in Toxicology: Present Status and Future Prospects (The Second Report of the FRAME Toxicity Committee) Following Page 440: Title page to Volume 11 Contents of Volume 11 Author Index to Volume 11 Subject Index to Volume 11