1. Risk Assessment of Chemical Hazards in Consumer Products by the U.S. Consumer Product Safety Commission Staff Michael A. Babich, PhD Directorate for Health Sciences U.S. Consumer Product Safety Commission February 28, 2011 This report was prepared by the CPSC staff; it has not been reviewed or approved by, and may not necessarily reflect the views of, the Commission.

2. U.S. Consumer Product Safety Commission Independent regulatory agency (1973) 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 $118 M 5 Commissioners appointed by President 2

3. 3 Federal Hazardous Substances Act (FHSA) Risk-based—considers toxicity, exposure, and bioavailability Includes acute and chronic effects Does not require specific testing for chronic hazards No pre-market approval – Consumer Product Safety Improvement Act (CPSIA) requires 3 rd party certification for children’s products Requires manufacturers to ensure that their products either are not hazardous or are properly labeled Children’s products that are hazardous are banned

4. Definition of “Hazardous Substance” Two-Part Definition: “Toxic” under the FHSA Cause “substantial” illness or injury from “reasonably foreseeable handling or use” 4

5. 5 Chronic Hazard Guidelines Carcinogenicity Neurotoxicity Reproductive/developmental toxicity Exposure Bioavailability Risk assessment Acceptable risk

6. 6 Hazard Identification Human data preferred Animal data generally used “Toxic” means toxic to animals: – at multiple doses, – in multiple organ sites, – by multiple routes of exposure, or – in multiple species or strains

7. 7 Acceptable Daily Intake No-observed adverse effect level (NOAEL) ADI = –NOAEL  10 if human data –NOAEL  100 if animal data –LOAEL  1000 if NOAEL not established Also called: –Reference dose (RfD) –Tolerable daily intake (TDI)

8. 8 Cancer Risk Linear dose response –No threshold Surface area scaling –Humans are 5- to 10-fold more sensitive than rodents

9. 9 Exposure Assessment Field data preferred –E.g., pollutant levels in indoor air Laboratory data –Emission or migration data –Combined with a mathematical model No exposure data –Surrogate chemical –Theoretical model –For screening purposes

10. 10 Risk Characterization Non-Carcinogens –Hazardous if Exposure > ADI Carcinogens –“ Hazardous” is cancer risk > 10 -6

11. Chronic Hazards in Consumer Products Asbestos—plaster patch, artificial embers Arsenic—Playground equipment made with pressure-treated lumber (CCA) Formaldehyde—urea-formaldehyde foam insulation (UFFI), pressed wood products Flame retardants—children’s sleepwear, upholstered furniture, mattresses Methylene chloride—paint strippers Phthalates—children’s products 11

12. Upholstered Furniture Fires Annual average of: – 2,800 fires – 320 deaths – 480 injuries – $150 million property damage – $1.9 billion in societal costs Ignition sources – Smoldering (cigarettes) – Small open flames (lighters & candles) Develop a flammability standard that: – Reduces furniture fire losses – Does not create other hazards to consumers 12

13. 13 FR-Treated Polyurethane Foam Samples Tris(1,3-dichloro-2-propyl) phosphate (TDCP) 2-Ethylhexyl Tetrabromobenzoate (EHTB) Triphenyl Phosphate (TPP) Di(2-Ethylhexyl) Tetrabromophthalate (EHTP ) Phenol Isopropylated Phosphate (PIP)

14. Availability of Toxicity Data Acute Subchronic Chronic Repro/Dev Neurotox Genetox Human Endpoints TDCPXXXXXX--Liver, kidney, testes PIPXX-- X XLiver, CNS TPPXX--XXXXLiver EHTB/PX-- ? 14 Bittner et al. 2001

15. 15 Mock-up for Migration Tests

16. 16 TDCP 6.6% TDCP 3.5% EHTB/P 6% Micrograms Extracted

17. 17 Apparatus for collecting airborne particles

18. 18 Exposure Assessment Dermal—Liquid extraction (mock-up) Oral—Liquid extraction (mock-up) Inhalation of particles – Impaction testing (mock-up) Inhalation of vapor phase – NRC mathematical model

19. 19 Exposure Assumptions Lifetime exposure (75 years) 3-Piece suite of furniture Particles released over 15 years 4 (0.5—16) hours/day adult exposure Wearing short sleeves & short pants Hand-to-mouth (adults & children) Mouthing for small children Two-zone mass-balance model – Breathing zone plus living/family room

20. 20 Estimated Exposure to Adults a TDCPTPP b PIP b EHTB/P ADD (µg/kg-d)9.51.80.180.20 Percent from: Dermal1.73.635.32.9 Oral0.50.98.57.7 Inhalation, vapor97.795.656.289.4 Inhalation, particles<0.1 ADI (µg/kg-d)5ND c ND Cancer risk / million300NA a ADD, average daily dose; ADI, acceptable daily intake; ND, not determined; NA, not applicable. b Dermal, oral, and inhaled particle exposures are based on data for EHTB/P. c Related compounds have ADI’s from 10 to 1,000 µg/kg-d.

21. 21 Estimated Exposure to Children  3 Years Old a TDCPTPP b PIP b EHTB/P ADD (µg/kg-d)264.80.40.55 Percent from: Dermal0.71.417.41.1 Oral0.61.012.49.1 Inhalation, vapor98.797.570.189.8 Inhalation, particles<0.1 ADI (µg/kg-d)5ND c ND a ADD, average daily dose; ADI, acceptable daily intake; ND, not determined; NA, not applicable. b Dermal, oral, and inhaled particle exposures are based on data for EHTB/P. c Related compounds have ADI’s from 10 to 1,000 µg/kg-d.

22. 22 Conclusions—Upholstered Furniture Triaryl phosphates nominated to NTP – Test plan under development EHTB/P—toxicity data needed Need additional exposure data – Vapor phase exposure Proposed upholstered furniture standard – Performance standard – Does not require FR-treated fabrics or foam – Inherently flame resistant interior barriers can be used

23. Additional Information Michael A. Babich – mbabich@cpsc.gov – 301-504-7253 CPSC Web Site – www.cpsc.gov www.cpsc.gov Chronic Hazard Guidelines – http://www.cpsc.gov/BUSINFO/chronic.pdf http://www.cpsc.gov/BUSINFO/chronic.pdf 23