Consumer Product Consumer Product Ingredient Safety Exposure and Risk Screening Methods for Consumer Product Ingredients 2nd Edition Ingredient Safety for Consumer Product Ingredients Exposure and Risk Screening Methods 2nd Edition Consumer Product Ingredient Safety Exposure and Risk Screening Methods for Consumer Product Ingredients Consumer Product Ingredient Safety Exposure and Risk Screening Methods for Consumer Product Ingredients Consumer Product Ingredient Safety Exposure and Risk Screening Methods for Consumer Product Ingredients, 2nd Edition American Cleaning Institute Washington, DC September 2010 Consumer Product Ingredient Safety nd Exposure and Risk Screening Methods for Consumer Product Ingredients, 2 Ed. For information, contact: American Cleaning Institute 1331 L Street, NW Suite 650 Washington, DC 20005, USA Telephone: +1-202-347-2900 Fax: +1-202-347-4110 Email: [email protected] Web: http://www.cleaninginstitute.org The information contained in this publication was created and/or compiled by the American Cleaning Institute (ACI) and is offered solely to aid the reader. Reasonable efforts have been made to publish reliable data and information, but ACI and its member companies do not make any guarantees, representations, or warranties, expressed or implied, with respect to the accuracy and completeness of the information contained herein and assume no responsibility for the use of this information. Neither ACI nor its member companies assume any responsibility to amend, revise, or update information contained herein based on information that becomes available subsequent to publication. Further, nothing herein constitutes an endorsement of, or recommendation regarding, any product or process by ACI. No part of this document may be reproduced or transmitted in any form or by any means, electronic or mechanical, including photocopying, recording or by any information storage retrieval system, without permission from the publisher. Copyright © 2010 American Cleaning Institute. All Rights Reserved. iv Consumer Product Ingredient Safety nd Exposure and Risk Screening Methods for Consumer Product Ingredients, 2 Ed. Preface to the Second Edition In 2004, The Soap and Detergent Association (SDA; now the American Cleaning Institute) published Exposure and Risk Screening Methods for Consumer Product Ingredients as a guide for companies engaged in stewardship of consumer products with repeated human exposures or environmental releases, especially via down-the-drain disposal. Included in the publication were several examples based on SDA’s experience in the US EPA and OECD high production volume (HPV) chemical programs. Since the initial publication, several of the submissions for particular chemical categories sponsored by SDA have been completed and accepted by the relevant HPV chemical program, and peer-reviewed journal articles have been published for those cases. The second edition, re-titled Consumer Product Ingredient Safety: Exposure and Risk Screening Methods for Consumer Product Ingredients to highlight the broader applicability of the publication, contains updated information on exposure assessment methodology as well as finalized case studies and the final manuscripts of the peer-reviewed articles as appendixes. The following contributed significantly to the development of this document: The SDA High Production Volume Chemicals Task Force; the Personal Care Products Council (formerly the Cosmetic, Toiletry, and Fragrance Association); the Consumer Specialty Products Association; the European Cosmetic Toiletry and Perfumery Association; the Human and Environmental Risk Assessment project; Exponent; and the Danish National Environmental Research Institute. A panel of international experts conducted a peer review which provided very helpful input in finalizing the document. v Consumer Product Ingredient Safety nd Exposure and Risk Screening Methods for Consumer Product Ingredients, 2 Ed. vi Consumer Product Ingredient Safety nd Exposure and Risk Screening Methods for Consumer Product Ingredients, 2 Ed. CONTENTS LIST OF TABLES .......................................................................................................... ix LIST OF FIGURES......................................................................................................... ix GLOSSARY .................................................................................................................... x 1. INTRODUCTION ......................................................................................................... 1 1.1. Aim and Audience ..................................................................................................................... 1 1.2. Background on the SDA/ACI HPV Chemical Program .......................................................... 1 1.3. Background on Screening-Level Risk Assessments for Priority Setting ........................... 3 1.4. References ................................................................................................................................. 6 2. RISK SCREENING METHODOLOGY FOR EXPOSURE TO HIGH PRODUCTION VOLUME CHEMICALS VIA CONSUMER PRODUCTS ............................................. 7 2.1. Background and Scope ............................................................................................................ 7 2.2. Objectives .................................................................................................................................. 8 2.3. General Framework ................................................................................................................... 8 2.4. Screening-Level Exposure Data .............................................................................................. 9 2.4.1. PE Estimates – Data Matrix .......................................................................................... 9 2.4.2. Screening-Level IC Data ............................................................................................. 14 2.5. Selecting NOAELs for Screening-Level Risk Characterization .......................................... 16 2.6. Screening-Level Assessments .............................................................................................. 18 2.6.1. Screening Based on Exposures ................................................................................ 18 2.6.2. Screening-Level Human Health Risk Characterization ........................................... 21 2.7. Consideration for Refinements.............................................................................................. 23 2.7.1. Refining Exposures .................................................................................................... 24 2.7.2. Identifying Relevant NOAELs .................................................................................... 25 2.8. Minor Exposure Scenarios Not Considered in Screening Assessment ............................ 25 2.9. Summary .................................................................................................................................. 25 2.10. References ............................................................................................................................... 26 3. EXPOSURE, EFFECTS, AND RISK SCREENING METHODOLOGIES FOR HIGH PRODUCTION VOLUME CHEMICALS VIA ENVIRONMENTAL RELEASES ....... 27 3.1. Background and Scope .......................................................................................................... 27 3.2. Assessment Tiers versus Levels .......................................................................................... 29 3.3. Exposure Assessment ............................................................................................................ 29 3.3.1. Objectives ..................................................................................................................... 29 3.3.2. Chemical Use and Exposure Information ..................................................................... 29 3.3.3. General Framework ...................................................................................................... 30 3.3.4. Basic Equations ............................................................................................................ 30 vii Consumer Product Ingredient Safety nd Exposure and Risk Screening Methods for Consumer Product Ingredients, 2 Ed. 3.3.5. Key Methodologies ....................................................................................................... 33 3.3.6. Identifying Relevant Environmental Compartments and Fate Processes .................... 33 3.3.7. Exposure Models Used in U.S. Assessments .............................................................. 33 3.3.8. Exposure Models Used in European Assessments ...................................................... 34 3.3.9. Exposure Models Used in Asia and the Pacific ............................................................ 35 3.3.10. Other International Exposure Modeling Resources ...................................................... 36 3.3.11. Use of Monitoring Data ................................................................................................. 36 3.4. Instructions for Generating PECs in the United States, European Union, and Japan..... 36 3.4.1. United States................................................................................................................. 36 3.4.2. European Union ...........................................................................................................