Collection and Dissemination of Exposure Data for Risk Screening of - PowerPoint PPT Presentation

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 in of E Exp xposure e (MOE OE) = = 𝑬𝑬𝑬𝑬 − 𝑺𝑬𝑬𝑺𝑬𝑺𝑬𝑬 𝑼𝑼𝑼𝑬𝑬𝑼𝑬𝑼𝑼 𝑸𝑼𝑬𝑼𝑸𝑸𝑸 𝑭𝑭𝑺𝑬𝑬𝑸𝑼𝑬 𝑸𝑭 × 𝑱𝑺𝑱𝑼𝑬𝑼𝑱𝑬𝑺𝑸 𝑫𝑬𝑺𝑸𝑬𝑺𝑸𝑼𝑫𝑸𝑱𝑬𝑺 ( 𝑱𝑫 ) 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) 𝐺𝐺 × 𝐵 × 𝑄𝑄 × 𝐷𝐺 × 𝐸𝐵 𝐶𝐶 • 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) 𝐵 × 𝑄𝑄 × 𝑄𝑄 × 𝐷𝐺 × 𝐸𝐵 𝐶𝐶 • 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