Consumer Product Exposure Assessment

1. Consumer Product Exposure Assessment Treye A. Thomas, Ph.D. U.S. Consumer Product Safety Commission Office of Hazard Identification and Reduction Bethesda, MD, USA April 6, 2010 These comments are those of the CPSC staff, have not been reviewed or approved by, and may not necessarily reflect the views of, the Commission.

2. U.S. Consumer Product Safety Commission—CPSC • Independent regulatory agency • Thousands of products in and around the home • Generally, food, drugs, cosmetics, medical devices, pesticides, automobiles not included • Does include child-resistant packaging for household chemicals, drugs, & cosmetics • Staff of ~530 • Budget of ~$105 M • 5 Commissioners appointed by President

3. Regulations • Consumer Product Safety Act (CPSA),15 U.S.C. § 2051-2084 • Federal Hazardous Substances Act (FHSA), 15 U.S.C. § 1261-1278 • Consumer Product Safety Improvement Act of 2008 (CPSIA)

4. Hazardous Substance • "Any substance or mixture of substances which (i) is toxic, (ii) is corrosive, (iii) is an irritant, (iv) is a strong sensitizer, (v) is flammable or combustible, or (vi) generates pressure through decomposition, heat, or other means, • If such substance or mixture of substances may cause substantial personal injury or substantial illness during or as a proximate result of any customary or reasonably foreseeable handling or use, including reasonably foreseeable ingestion by children."

5. Federal Hazardous Substances Act • Risk-based • Considers toxicity, exposure, and bioavailability • Includes acute and chronic effects • Does not require specific testing for chronic hazards • Does not provide for pre-market approval • Requires manufacturers to ensure that their products are not hazardous or properly labeled • Children’s products that are hazardous are banned

6. Chronic Hazard Guidelines • In 1992, the Commission issued guidelines for assessing chronic hazards under the FHSA • Intended to assist manufacturers in complying with the FHSA • Provides guidance on • Determining toxicity (e.g., carcinogenicity, neurotoxicity, reproductive/developmental toxicity, bioavailability) • Acceptable Daily Intake (ADI) • Threshold for uptake into body • Assessing exposure • Risk assessment approaches and acceptable risk

7. Exposure Assessment • Population estimates • Variation in use patterns, frequency of use, diversity of products, variation in types of housing • Human factors evaluation of consumer interaction • Published studies • Other agency guidelines (e.g., EPA Exposure Factors Handbook) • Professional judgment • Best estimate (50th percentile) • Upper (95th percentile) and lower bound (5th percentile) screening • Uncertainty – often assume reasonable worst-case scenario • Reasonably foreseeable misuse • Mouthing by young children

8. Estimating Exposure • Three routes of exposure considered: inhalation, ingestion, dermal • Inhalation • Direct monitoring • Modeling • Surrogate data • Ingestion • Extraction with simulated saliva or gastric juices • Assume mouthing by children • Dermal • Estimating amount of substance in contact with skin • Experiments to quantify material leaching from product • Surface area of skin contacted • Duration • Frequency of contact • Thickness of liquid interfacial layer

9. Exposure and Risk • Hazard Index (HI) calculated for non-cancer risk • HI = average daily dose (ADD)/ acceptable daily intake (ADI) • When HI is greater than one • Exposure scenario considered to present a hazard to consumers • Individual excess cancer risk for carcinogens (R) • R = unit cancer risk (Q) x lifetime average daily dose (LADD)

10. Challenges in Exposure Assessment • Product Ingredients • Consumer Use Information • Method Validation • Probabilistic Methods • International Cooperation • Nanotechnology

11. Nanomaterials in Consumer Products • Woodrow Wilson International Center inventory of 1000 consumer products that are reported to contain nanomaterials • A large number of products that are expected to contain nanomaterials will fall under CPSC regulatory authority • Aerosol household chemicals, apparel, sports equipment, paint and building materials • No pre-market notification • Products that contain nanomaterials • Specific nanomaterials incorporated in these products. • Identify products that claim or are believed to contain nanomaterials • Develop a database with detailed information on these products.

12. Data Needs for Exposure and Risk Assessment of Nanomaterials • Identify consumer products that contain nanomaterials • Characterize nanomaterials in a consumer product • Determine size distribution of particles released from products • Toxicity data for those sizes - does toxicity change ? • Coatings – does toxicity change? • Instrumentation • Development of analytical protocols • Feasibility

13. Nanotechnology Exposure Research • CPSC will collaborate with other federal agencies • Better understand the potential health effects associated with human exposure to the release of nanoparticles into the environment and indoor air. • Federal agencies CPSC will collaborate with include: • National Institute for Standards and Technology (NIST) • Environmental Protection Agency (EPA) • National Institute for Occupational Safety and Health (NIOSH) • Select products for review

14. Examples of Nanomaterial Exposure Testing • (2008) IAG with NIOSH • Evaluate the particulate aerosol generated during use of an antimicrobial spray product containing Titanium Dioxide (TiO2) anoparticles • (2010) Testing to determine exposure impact of bathroom • (2009) IAG with NIST • Evaluate the flammability performance and exposure potential of selected nanomaterials used as flame-retardants. • (2010) IAG with NIOSH and EPA • Develop experimental procedures to evaluate exposure potential to nanosilver from consumer products, • Specialemphasis will be placed on exposures to young children.

15. Head-over-Heels Apparatus

16. Inhalation Exposure Study

17. Dermal Exposure Mini Mattress

18. Summary • Toxicity and exposure assessment are critical components in assessing potential risks from consumer products • Approach to regulating products with nanomaterials will likely be similar to approach used to regulate products containing other chemicals • Need for new toxicity data and exposure assessment (analytical) techniques appropriate for nanomaterials • Exposure assessment studies needed to determine potential risks from nanomaterials • Critical for public acceptance of nanomaterials in products