Collection and Dissemination of Exposure Data for Risk Screening of Formulated Consumer Products Presented By: Dr. Paul C. DeLeo Senior Director, Environmental Safety 21 st Annual Meeting of the International Society of Exposure Science Baltimore, Maryland October 24, 2011 1
Co-Authors Dr. Hans Sanderson Danish National Environmental Research Institute/ Aarhus University, Roskilde, DENMARK Dr. Christina Cowan-Ellsberry CE 2 Consulting LLC, Cincinnati, Ohio Mr. William J. Greggs Sanibel, Florida 2
Who are we? The 117-member trade association of the $30 billion US cleaning products industry 3
What do we do? ACI has conducted ingredient safety research for over 50 years ACI sponsored nearly 300 of 2,700 high production volume chemicals under EPA and OECD programs over the last decade ACI provided beyond-sids (screening information data set) information including screening-level risk assessments of its ingredients 4
How did we do it? Formed ten chemical-specific consortia Leveraged the expertise of 62 chemical suppliers and product formulators Prepared >6,100 robust study summaries Identified relevant product exposure models Conducted screening-level risk assessments 5
Human Health Screening-Level Risk Characterization Algorithm Margin of Exposure (MOE) = DDDD RRRRRRRR TTTTTTTTT PPPPPPP EEEEEEEE PP IIIIIIIIII CCCCCCCCCCCCC (II) 6
Product Exposure Scenarios Dermal: Direct (use) Cleaning (rinse-off) Personal Care (leave-on & rinse off) Indirect Cleaning-Laundry: clothes wearing Oral: Direct (use) Personal Care/OTC drug Indirect Cleaning: dishwashing Inhalation: Direct (use) Aerosols/Volatiles Laundry Powders Trigger Sprays 7
Dermal-Direct Exposure Scenario (North American & EU Personal Care Approach) FF A PP CC DD BB FQ: frequency of product use (use/day) A: amount of product used (g/use) PR: percent retained (%) CF: conversion factor (1,000 mg/g) DA: dermal absorption (100%) BW: body weight (70 kg male/60 kg female/15 kg child) 8
Dermal-Indirect Exposure Scenario (North American Approach for Laundered Clothing) A PP PP CC DD BB A: amount product used (g/day) PR: percent retained on clothing PT: percent transferred from clothing to skin CF: conversion factor (1,000 mg/g) DA: dermal absorption (100%) BW: female body weight (60 kg) 9
How are products used by consumers? Exposure factors for formulated consumer products: Frequency of product use Amount of product per use (dosing) Duration of use (time to rinse-off) 10
Assemble Habits & Practices Data Survey government reports Survey the open literature Survey our members Survey other industries 11
Data Sources Regulatory authorities (e.g., EPA Exposure Factors Handbook, EU Technical Guidance Document) Submissions to regulatory authorities (e.g., AISE- CEFIC HERA, AIHC exposure initiative assessments) Published literature Survey data collected by industry associations (i.e., CTFA/PCPC, COLIPA, AISE, SDA/ACI) Member company data 12
Data Sources, cont. Cleaning product habits and practices For laundry, dishwashing & hard surface cleaners North America: SDA (Sanderson et al., 2006) Europe: AISE/CEFIC HERA Guidance Document (2005) (http://www.heraproject.com) Personal care product habits and practices For 12 product types covering 95% of exposures U.S.: CTFA/PCPC (Loretz et al., 2005, 2006, 2008) Europe: (Hall et al., 2007, 2011) 13
What is the concentration of an ingredient in a products? What ingredients are in products? SDA 2001 member survey 14
What ingredients are in products? Mandatory ingredient reporting Cosmetic labeling (except fragrances, dyes, preservatives) Fragrance Industry published a list of fragrance ingredients used in consumer goods by their customers worldwide in 2010 Cleaning product labeling in Europe Voluntary ingredient reporting for cleaning products N. American Ingredient Communication (ACI/CSPA/CCSPA) (http://www.cleaninginstitute.org/ingredientcentral/) Australia What s In It? campaign (ACCORD) 15
SDA 2001 Member Survey (Concentration of ingredients in products) Manufacturers, importers, processors and formulators Consumer, commercial & industrial products Ten families of chemicals Regional use: N. America, Europe, Asia/Pacific 16
SDA 2001 Member Survey, cont. Chemical production/importation volume Chemical use by product category (e.g., liquid laundry detergent) Chemical releases to the environment Conditions under which potential worker exposures are mitigated Concentration range in formulated products (<0.1%, 0.1<0.5%, 0.5<1%, 1<5%, 5<10%, 10<25%, 25<50%, 50<75%, 75<100%) 17
Reported Use & Concentration Data Minimum/maximum ingredient concentration Product categories Laundry: 9 product types Dishwashing: 3 product types General Cleaning: 7 product types Personal Care: 15 product types Cosmetics: 4 product types North America, Europe and Japan 18
Reported Use & Concentration Data, cont. Concentration data across the five product categories for seven chemical categories Aliphatic Acids Aliphatic Alcohols Alkyl Sulfates Amine Oxides Hydrotropes LAS Triclocarban 19
One-stop Shopping Risk screening methodology Exposure factors for formulated consumer products Case studies: peer-reviewed journal articles Ingredient concentration data Available on ACI Science website (aciscience.org) 20
Conclusions Extensive information about the safety of ingredients in formulated consumer products is now publicly available, especially for high volume chemicals Product exposure information is widely available While generally proprietary, some ingredient concentration info is publicly (freely) available Release of chemical use and exposure information will continue and likely accelerate 21
References Hall, B., S. Tozer, B. Safford, M. Coroama, W. Steiling, M.C. Leneveu-Duchemin, C. McNamara, M. Gibney. 2007. European consumer exposure to cosmetic products, a framework for conducting population exposure assessments. Food Chem. Tox. 45: 2097-2108. Hall, B., W. Steiling, B. Safford, M. Coroama, S. Tozer, C. Firmani, C. McNamara, M. Gibney. 2011. European consumer exposure to cosmetic products, a framework for conducting population exposure assessments Part 2. Food Chem. Tox. 49: 408-422. Human and Environmental Risk Assessment on Ingredients of Household Cleaning Products (HERA). 2005. Guidance Document Methodology. Available at: http://www.heraproject.com/files/hera TGD February 2005.pdf Loretz, L.J., A.M. Api, L.M. Barraj, J. Burdick, W.E. Dressler, S.D. Gettings, H. Han Hsu, Y.H.L. Pan, T.A. Re, K.J. Renskers, A. Rothenstein, C.G. Scrafford, C. Sewall. 2005. Exposure data for cosmetic products: lipstick, body lotion, and face cream. Food Chem. Tox. 43:279-291. Loretz, L., A.M. Api, L. Barraj, J. Burdick, D. Davis, W. Dressler, E. Gilberti, G. Jarrett, S. Mann, Y.H.L. Pan, T. Re, K. Renskers, C. Scrafford, S. Vater. 2006. Exposure data for personal care products: Hairspray, spray perfume, liquid foundation, shampoo, body wash, and solid antiperspirant. Food Chem. Tox. 44: 2008-2018. Loretz, L.J., A.M. Api, L. Babcock, L.M. Barraj, J. Burdick, K.C. Cater, G. Jarrett, S. Mann, Y.H.L. Pan, T.A. Re, K.J. Renskers, C.G. Scrafford. 2008. Exposure data for cosmetic products: Facial cleanser, hair conditioner, and eye shadow. Food Chem. Tox. 46: 1516-1524. Sanderson, H. J.L. Counts, K.L. Stanton and R.I. Sedlak. 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(6): 1637-1657. 22
Thank You Dr. Paul C. DeLeo Senior Director, Environmental Safety American Cleaning Institute 1331 L Street, N.W., Suite 650 Washington, D.C. 20005 202-662-2516 pdeleo@cleaninginstitute.org http://www.aciscience.org 23