1. Alex Stone, Sc. D. Safer Chemical Alternative Chemist WA Dept. of Ecology Exposure Science Community of Practice Teleconference May 11, 2010 1

2. Background Massive recall of toys in 2007 for high lead levels One child died from swallowing lead charm Concerns for many other children from similar exposures Children’s Safe Product Act Passed in WA in April 2008 followed by similar legislation in ME, CT, etc. Restricted lead, cadmium and 6 phthalates in children’s products Required Ecology to establish a list of chemicals of high concern to children (CHCCs) Any product manufactured or sold in WA containing any CHCC above established limit must be reported to Ecology 2

3. Background (cont.) Federal Consumer Product Safety Improvement Act passed in August 2008 Preempted state legislation Established less restrictive limits for lead and phthalates Ecology determined CSPA reporting requirements not preempted by federal legislation Continued with process for identifying CHCCs 3

4. CSPA Implementation Three Phases 1. Identification of Chemicals of High Concern to Children (CHCCs) 2. Prioritization of CHCCs 3. Final review and determination of CHCCs to be placed into regulation 4

5. Phase 1 Identify High Priority Chemicals (HPC) Identify Chemicals in Potential Exposure Sources Identify Chemicals of High Concern to Children (CHCCs), i. e. chemicals that are: 1. An HPC and 2. Found in at least one of the potential exposure pathways

6. ‘High Priority Chemicals’ (HPCs): (From legislation) Section 2: Definitions ‘High priority chemical’ as identified by: State agency Federal agency Accredited research university Other scientific evidence deemed authoritative by Ecology One or more of the following criteria: a)Developmental toxin b)Cause: Cancer Genetic damage Reproductive harm Endocrine disruptor c)Damage: Nervous system Immune system Organs Other systemic toxicity d)PBT e)vPvB (very persistent & very bioaccumulative) HPCs 6

7. HPC Sources: United States: Federal United States: State Prop 65-Total721 EPA TRI PBT Chemicals 64 Prop 65 Cancer 509 EPA VCCEP 23 Prop 65 Developmental 256 Nat. Waste Min. Program Priority Chem. 33 Prop 65 Female 42 National Toxicology Program Reproduction 39 Prop 65 Male 60 National Tox. Program Carcinogens-Known 55 WA PBTs 74 National Tox. Program Carcinogens-Suspected 181 International: Europe IRIS Total 128 EU Endocrine Disruptors Cat 1 91 IRIS 1986 Category A (known) 11 EU Endocrine Disruptors Cat 2 54 IRIS 1986 Category B1 (probable-humans) 5 EU SVHC (Substances of Very High Concern) 16 IRIS 1986 Category B2 (probable-animal) 65 EU PBTs 28 IRIS 1986 Category C (possible) 39 EU Chemicals identified for Risk Assessment 140 IRIS 1996 Known/likely 8 OSPAR Chemicals of Concern 306 IRIS 1999 Carcinogens4 OSPAR 1997 Chemicals for Priority Action35 IRIS 2005 Suggestive Evidence1 IARC Group 1 Known Carcinogens 47 IRIS Other423 IARC Group 2a Probable Carcinogens 52 IARC Group 2b Possible Carcinogens 222 OtherInternational: Canada Grandjean Neuro/developmental toxicants 201 Canadian PBiT list 393 7

8. 8 Primary Toxicity CriteriaSource of InformationNr. of HPCs CarcinogenicityProp 65446 NWMP8 IARC321 IRIS138 NTP238 DNR toxicity (dev., neurodev. &Prop 65414 repro. toxicity)VCCEP23 Grandjean and Landrigan (2006)202 NTP39 CMR toxicityNWMP20 ESR141 SVHC10 Endocrine disruptionEU ED317 OSPAR22 PBTCEPA PB i T393 TRI72 NWMP5 EU PBT61 SVHC5 OSPAR336 WA PBT75 vPvBSVHC1 Other (systemic, target organ, etc.)IRIS423 3710 Total (sum) 2160 Unique (sum) 2044 Unique (CAS)

9. HPC Sources: (cont.) 9 Coordinated with other states like ME although differences exist between state approaches WA included chemicals ‘suspected’ or ‘possible’ for some toxicity criteria Did not want these chemicals selected as potential safer alternatives Differentiated between sources Potential ‘emerging chemicals’ for which the science is not as developed or easily ascertained (in green) ‘Emerging chemicals’ removed from prioritization process Sources as of October 2008-recent changes not reflected

10. Identify chemicals of high concern to children (CHCCs): (From legislation) Section 4: Identifying high priority CHCCs after considering a child’s or developing fetus’s potential for exposure to each chemical. One or more of the following criteria: Chemicals found in biomonitoring studies: a) Humans  Umbilical cord blood  Breast milk  Urine  Other bodily tissues or fluids b) Chemicals found in:  Household dust  Indoor air  Drinking water  Elsewhere in the home c) Added or present in consumer product used or present in the home 10 Exposure

11. Exposure Selection Criteria 1. Generated data in Four Biomonitoring & potential exposure areas – Biomonitoring  NHANES & Danish Birth Cohort  Journal Articles – Indoor Air & Dust  CA Air Resources Board  Journal Articles – Drinking Water  EPA drinking water standards  Journal Articles – Consumer Products  Primarily Danish and Dutch consumer product studies  Separated chemicals found in children’s products from those found in general consumer products 11

12. Exposure Selection Criteria (cont.) 2. Supplemented with scientific, peer-reviewed journals Environmental Health Perspectives Environmental Science & Technology Society of Toxicology Others as appropriate Journals: Environmental Science and Technology: http://pubs.acs.org/search/advancedhttp://pubs.acs.org/search/advanced Environmental Health Perspectives: http://www.ehponline.org/http://www.ehponline.org/ Toxicological Sciences: http://toxsci.oxfordjournals.org/search.dtlhttp://toxsci.oxfordjournals.org/search.dtl 12 Biomonitoring: AdiposeBiomonitoring BloodBlood level Breast milkCord blood Cord serumPlacenta HumanHuman Exposure Infant Infant Exposure TissueMaternal blood UrineExposure General: ChildrenChild Indoor Air & Dust Indoor AirDust HouseHome Indoor Drinking water: Drinking waterPublic water Water supplyWater Products: Consumer productsToys ProductProducts

13. Exposure Selection Criteria (cont.) 3. Papers only from recent years Concerns about methodologies used in older papers Methodologies standardized over recent years 4. Data omitted: Non-scientific sources (NGO, business, etc.) Scientific studies done in third world or developing − Exception: Inuits and other aboriginal people, ‘canaries in the coal mine’ Limited papers on specific chemicals once presence established − Don’t need hundreds of papers on PCBs, PBDEs, chlorinated pesticides, etc. − If covered in primary sources, not added to work − Consider adding additional papers but low priority 13

14. 14 Exposure Information SourceNumber of Chemicals Biomonitoring Studies280 Drinking Water239 Indoor Air and House Dust290 Consumer Products1,798 2,607 Total 2,419 Unique (sum) 2,219 Unique (CAS) Exposure Chemical Results

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16. Phase 2 Governor’s veto message directed Ecology to place greater emphasis upon chemicals found in children’s products Prioritized products based upon 3 toxicity criteria of most importance to children and presence in children’s products Used a ‘weight-of-evidence’ approach 16

17. Phase 2 (cont.) Chemicals removed before further prioritization: 17 178 476

18. Phase 2 (cont.) Toxicity criteria Process created by Catherine Karr, MD, PhD, Dept. of Pediatrics and Dept. Environmental & Occupational Health Sciences, University of Washington 18

19. Phase 2 (cont.) 19 I.Developmental or Reproductive Toxicity WorstSevereBadNo Info Value or Comment 1.Prop 65 Identified as developmental toxicantYesNoNI 2.NTP CERHR finding Clear or some evidence of adverse effects in humansYes Limited evidence in humans or some evidence in animalsYes Limited evidence in animalsYes Some or clear evidence of no observable adverse effectsYes 3.EU Existing Substances Identified as Category 1, 2 or 3Cat 1Cat 2Cat 3NI 4.GHS Identified as Category 1A, 1B or 2 for reproductive toxicity or germ cell mutagenicity Cat 1ACat 1BCat 2NI 5.REPROTEXT Rated as A +, A, A -, B +, B, B -, C, D, E, FA+, AA-, B+BE, FB -, C, D 6.LOAEL or RTECS TDLo or TCLo Oral value (mg/kg-bw/day)< 50≥ 50 - ≤ 250> 250NI Dermal value (mg/kg-bw/day)< 100≥ 100 - ≤ 500> 500NI Inhalation (vapor) value (mg/L/day)< 1.0≥ 1.0 - ≤ 2.5> 2.5NI Inhalation (dust/mist/fume) value (mg/L/day)< 0.1≥ 0.1 - ≤ 0.5> 0.5NI Inhalation (gas) value (ppm/day)< 50≥ 50 - ≤ 250> 250NI

20. Phase 2 (cont.) Exposure Criteria Process created by Catherine Karr, MD, PhD, Dept. of Pediatrics and Dept. Environmental & Occupational Health Sciences, University of Washington 20

21. Phase 2 (cont.) 21 I.Presence in a child product KnownPossibleUnlikelyNo Info Value or Comment 14.Found in Danish EPA or Dutch studies and reportsYesNI 15.EU or authoritative Risk Assessment indicating use in children’s products YesNI 16.Evidence in data in HSDB indicating possible use in children’s products YesNI 17.Environmental Working Group database if used in cosmetics or sunscreens YesNI 18.EPA’s Inventory Use and Reporting database (IUR)YesNI 19.NLM Household products databaseYesNI

22. Phase 2 (cont.) 22 Segregated 178 potential CHCCs into the following ‘bins’ Reduced 178 potential CHCCs to 65

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24. Phase 3 Final review of 65 CHCCs to determine those placed into regulation Four components part of final determination: 1. Final toxicity and exposure review 2. Determination of a reasonable analytical method 3. Determination of a reporting level 4. Overall policy review In the meantime conducting Pilot Rule 24

25. Pilot Rule Create draft rule Work with regulated community and interested parties to evaluate effectiveness of proposed rule Based upon input, propose final rule which will contain final list of CHCCs Undergo formal public comment process Once finalized, any product sold or manufactured in WA must report to Ecology presence of chemical in product and certain additional information 25

26. Links Children Safe Product Act & Pilot Rule Process: http://www.ecy.wa.gov/programs/swfa/rules/ruleChildSa fePilot.html Phase 1 process, Stone and Delistraty, 2009, ‘Sources of toxicity and exposure information for identifying chemicals of high concern to children’: http://www.sciencedirect.com/science?_ob=ArticleURL& _udi=B6V9G-4Y5H5XP- 1&_user=10&_rdoc=1&_fmt=&_orig=search&_sort=d&_d ocanchor=&view=c&_acct=C000050221&_version=1&_ur lVersion=0&_userid=10&md5=6cbd6a426cb849743c8d2 7f7da883874 26

27. Contacts Alex Stone Safer Chemical Alternative Chemist Washington State Dept. of Ecology alex.stone@ecy.wa.gov Phone: (360) 407-6758 27