Consumer Product Ingredient Safety Exposure and Risk Screening Methods for Consumer Product Ingredients 2nd Edition 2nd Edition Exposure and Risk Screening Methods Consumer Product Ingredient Safety 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 Consumer Product Ingredient Safety Exposure and Risk Screening Methods for Consumer Product Ingredients, nd 2 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: 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 ............................................................................................................ 40 3.4.3. Japan ............................................................................................................................ 44 3.5. Exposure Assessment Summary .......................................................................................... 45 3.6. Effects Assessment ................................................................................................................ 45 3.6.1. Objective ....................................................................................................................... 46 3.6.2. Data Evaluation ............................................................................................................. 46 3.6.3. Assessment Factors Approach ..................................................................................... 46 3.6.4. Statistical Extrapolation Process................................................................................... 48 3.7. Comparison of PEC and PNEC .............................................................................................. 49 3.8. Related Compartments ........................................................................................................... 50 3.9. Summary .................................................................................................................................. 51 3.10. References ............................................................................................................................... 51 4. APPENDIXES .......................................................................................................... 53 Appendix I-A Sources of Product Exposure (PE) Models and Model Inputs Parameters ........................................ 55 Appendix I-B Primary, Secondary, and Selected References for Exposure Models and Factors ........................... 61 Appendix II-A Screening Product Exposure Data Matrix: Default High-End Values .................................................. 71 Appendix II-B Screening Product Exposure Data Matrix: Min-Max Values ................................................................. 85 Appendix III. Case Studies ....................................................................................................................... 97 Appendix III-A Amine Oxides (AO) – Human Health Sanderson H, Counts JL, Stanton KL, Sedlak RI. 2006. Exposure and prioritization – human screening data and methods for high production volume chemicals in consumer products: amine oxides, a case study. Risk Analysis 26:1637–1657. DOI: 10.1111/j.1539-6924.2006.00829.x ................................................... 101 Appendix III-B Amine Oxides (AO) – Environmental Safety Sanderson H, Tibazarwa C, Greggs W, Versteeg DJ, Kasai Y, Stanton K, Sedlak RI. 2009. High production volume chemical amine oxides [C8–C20] category environmental risk assessment. Risk Analysis 29:857–867. DOI: 10.1111/j.1539-6924.2009.01208.x ................................................................. 127 viii Consumer Product Ingredient Safety nd Exposure and Risk Screening Methods for Consumer Product Ingredients, 2 Ed. Appendix III-C Long Chain Alcohols (LCOH) – Category Overview Sanderson H, Belanger SE, Fisk PR, Schäfers C, Veenstra G, Nielsen AM, Kasai Y, Willing A, Dyer SD, Stanton K, Sedlak RI. 2009. An overview of hazard and risk assessment of the OECD high production volume chemical category – Long chain alcohols [C6--C22] (LCOH). Ecotoxicology and Environmental Safety 72:973–979. DOI:10.1016/j.ecoenv.2008.10.006 ................................................................................... 141 Appendix III-D Long Chain Alcohols (LCOH) – Human Health Risk Assessment Veenstra G, Webb C, Sanderson H, Belanger SE, Fisk P, Nielsen A, Kasai Y, Willing A, Dyer S, Penney D, Certa H, Stanton K, Sedlak R. 2009. Human health risk assessment of long chain alcohols. Ecotoxicololgy and Environmental Safety 72:1016–1030. DOI:10.1016/j.ecoenv.2008.07.012 ................................................... 155 Appendix III-E Long Chain Alcohols (LCOH) – Environmental Risk Assessment Belanger SE, Sanderson H, Fisk P, Schäfers C, Mudge SM, Willing A, Kasai Y, Nielsen AM, Dyer SD, Toy R. 2009. Assessment of the environmental risk of long-chain aliphatic alcohols. Ecotoxicology and Environmental Safety 72:1006-1015. DOI:10.1016/j.ecoenv.2008.07.013 .......................................................... 185 Appendix IV-A Summary of Chemical Awareness Framework for Evaluation of High Production Volume (HPV) Chemicals for Human Exposure and Risk ................................................................... 205 Appendix IV-B Summary of Chemical Awareness Framework for Evaluation of High Production Volume (HPV) Chemicals for Potential Ecologic Exposure and Risk ............................................... 207 List of Tables Table 2-1. Summary of Model Equations Used to Calculate Product Exposure (PE) ............................... 11 Table 2-2. Ingredient Concentration Data Matrix for the HPV Chemical Category Amine Oxide (AO) ..... 15 Table 2-3. Hypothetical Hazard Data Matrix .............................................................................................. 17 Table 2-4. HPV Chemical Category AO Hazard Data Matrix .................................................................... 18 Table 2-5. HPV Chemical Category AO Screening-Level Exposures by PE Scenarios ........................... 19 Table 2-6. Exposures to AO by Product Category ..................................................................................... 20 Table 2-7. Contribution of Total Exposure by Product Type (%) ............................................................... 20 Table 2-8. Hypothetical Outputs from a Screening Risk Characterization ................................................ 21 Table 2-9. Screening-Level MOEs from AO Exposures by Product Category ......................................... 21 Table 3-1. Assessment Factors for the Derivation of PNECs from Aquatic Toxicity Data......................... 47 List of Figures Figure 1-1. Generic Exposure Framework ....................................................................................................4 Figure 2-1. Screening-Level Assessment – Continual Refinement Process ............................................. 24 Figure 3-1. Pathways to the Environment of Chemicals Produced and Used in Consumer Products ..... 31 Figure 3-2. Exposure Assessment Approach ............................................................................................ 32 Figure 3-3. U.S. Exposure Assessment Process ....................................................................................... 37 Figure 3-4. EU Exposure Assessement Process ....................................................................................... 41 Figure 3-5. Extrapolation from a Species-Sensitivity Distribution .............................................................. 49 ix Consumer Product Ingredient Safety nd Exposure and Risk Screening Methods for Consumer Product Ingredients, 2 Ed. GLOSSARY ACI: American Cleaning Institute, formerly the Soap and Detergent Association (SDA) acute exposure: Human - one exposure or multiple exposures occurring within a short time (24 hours or less). Environmental - exposures lasting far less than a reproductive cycle of an organism, generally 24 to 96 hours but species dependent. aggregate exposure: Total exposure to all individual products containing the same chemical or similar chemicals from the same category to which a consumer is likely exposed. AIHC: American Industrial Health Council AISE: Association Internationale de la Savonnerie de la Détergence et des Produits d’Entretien, or International Association for Soaps, Detergents and Maintenance Products. Represents the European soap, detergent, and maintenance product industries. allowable daily intake (ADI): Estimate of the amount of a substance in food or drinking water, expressed on a body mass basis (usually mg/kg body weight), which can be ingested daily over a lifetime by humans without appreciable health risk. APAG: The European Oleochemicals and Allied Products Group assessment factors: Numbers used to extrapolate available toxicity data to predict actual toxicity. Available toxicity data are divided by numbers generally ranging from 1 to 1,000 to address uncertainties in the use of the toxicity data to protect human health and the environment. CESIO: Comité Européen des Agents de Surface et de Leurs Intermédiaires Organiques, or European Committee of Organic Surfactants and Their Intermediaries Chemical Abstract Service (CAS) number: A unique number for each chemical issued by the Chemical Abstract Service; used to search for a specific chemical regardless of the choice of chemical name. Chemical Awareness (CA): Formerly the Alliance for Chemical Awareness; a voluntary initiative by chemical and consumer product manufacturers to enhance the accessibility to the public of information pertaining to major chemicals in commerce. chronic effect: An effect that is manifested due to repeated exposure over time. See also chronic exposure. chronic exposure: Multiple exposures occurring over an extended period of time or over a significant fraction of the animal’s or individual’s lifetime. Concentration-response: A relationship between the exposure concentration and the biological response (effect) to that exposure. Dose-response: A correlation between a quantified exposure (dose) and the proportion of a population that demonstrates a specific effect (response). ECx: The effective concentration or concentration of the substance causing an x% decline in the biological parameter of interest (e.g., reproduction, growth). Similar to the LCx, or concentration causing x% mortality. Typically calculated using concentration response statistics; avoids some of the interpretation problems associated with NOECs. exposure: Contact between a chemical, physical, or biological agent and the outer boundary of an organism. Exposure is quantified as the amount of an agent available at the exchange boundaries of the organism (e.g., skin, lungs/gills, gut). x