Alex Stone Chemist, WA Dept. of Ecology EPA Prioritization Workshop April 6-7,

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 2

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

‘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 4

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. Prg. Priority Chem. 33 Prop 65 Female 42 Nat. Tox Prg. Reproduction 39 Prop 65 Male 60 Nat. Tox Prg. Carcinogens-Known 55 WA PBTs 74 Nat. Tox Prg. 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 Oral RfD Critical Effects4 IARC Group 2a Probable Carcinogens 52 IARC Group 2b Possible Carcinogens 222 OtherInternational: Canada Grandjean Neuro/developmental toxicants 201 Canadian PBiT list 393 5

From HPCs, identify ‘chemicals of high concern to children (CHCCs): (From legislation) Exposure Lists: Section 4: Identifying high priority chemicals of high concern for children 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 6 Exposure

Exposure Chemical Selection  Generated data in 4 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 – Products  Primarily Danish and Dutch consumer product studies 7

8 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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Chemicals removed before further prioritization:

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 11

Phase 2 Toxicity criteria 1. Developmental or reproductive toxicity 2. Endocrine disruption 3. Carcinogenicity Exposure criteria 1. Presence in Children’s products 2. Exposure potential from those products 3. Known exposure in general population Created ‘Score Card’ to evaluate CHCCs Filled out score cards on 178 potential CHCCs 12

Phase 2 (cont.) 13 KnownPossibleUnlikely Worst29150 Severe16320 Bad240 Add WA PBTs back onto list Reduced 178 to 65 potential CHCCs

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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 15

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 16

Links Children Safe Product Act & Pilot Rule Process: ldSafePilot.html Phase 1 process: RL&_udi=B6V9G-4Y5H5XP- 1&_user=10&_rdoc=1&_fmt=&_orig=search&_sort=d &_docanchor=&view=c&_acct=C &_versio n=1&_urlVersion=0&_userid=10&md5=6cbd6a426c b849743c8d27f7da

Contacts Alex Stone Chemist Washington State Dept. of Ecology Phone: (360)