Selection and Prioritization of Chemicals for WAs Childrens

Selection and Prioritization of Chemicals for WAs Childrens

Selection and Prioritization of Chemicals for WAs Childrens Safe Product Act (CSPA) Alex Stone, Sc. D. Safer Chemical Alternative Chemist WA Dept. of Ecology Exposure Science Community of Practice Teleconference May 11, 2010 1 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 Childrens Safe Product Act Passed in WA in April 2008 followed by similar legislation in ME, CT, etc. Restricted lead, cadmium and 6 phthalates in childrens 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 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 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 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 6 HPC Sources: United States: Federal United States: State EPA TRI PBT Chemicals EPA VCCEP Nat. Waste Min. Program Priority Chem. National Toxicology Program Reproduction National Tox. Program Carcinogens-Known 64 23 33 39 55 National Tox. Program Carcinogens-Suspected 181 128 11 5 65

39 8 4 1 423 IRIS Total IRIS 1986 Category A (known) IRIS 1986 Category B1 (probable-humans) IRIS 1986 Category B2 (probable-animal) IRIS 1986 Category C (possible) IRIS 1996 Known/likely IRIS 1999 Carcinogens IRIS 2005 Suggestive Evidence IRIS Other Other Grandjean Neuro/developmental toxicants Prop 65-Total Prop 65 Cancer Prop 65 Developmental Prop 65 Female Prop 65 Male WA PBTs 721 509 256 42 60 74 International: Europe EU Endocrine Disruptors Cat 1 EU Endocrine Disruptors Cat 2 EU SVHC (Substances of Very High Concern)

EU PBTs EU Chemicals identified for Risk Assessment OSPAR Chemicals of Concern OSPAR 1997 Chemicals for Priority Action IARC Group 1 Known Carcinogens IARC Group 2a Probable Carcinogens IARC Group 2b Possible Carcinogens 91 54 16 28 140 306 35 47 52 222 International: Canada 201 Canadian PBiT list 393 7 Primary Toxicity Criteria Carcinogenicity Source of Information Prop 65 NWMP IARC IRIS NTP

Nr. of HPCs 446 8 321 138 238 DNR toxicity (dev., neurodev. & repro. toxicity) Prop 65 VCCEP Grandjean and Landrigan (2006) NTP 414 23 202 39 CMR toxicity NWMP ESR SVHC 20 141 10 Endocrine disruption EU ED OSPAR 317 22

PBT CEPA PBiT TRI NWMP EU PBT SVHC OSPAR WA PBT 393 72 5 61 5 336 75 vPvB SVHC 1 8 HPC Sources: (cont.) 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 9 Identify chemicals of high concern to children (CHCCs): (From legislation) Section 4: Identifying high priority CHCCs after considering a childs or developing fetuss 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 Exposure 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 Selection Criteria

1.Generated data in Four Biomonitoring & potential exposure areas Biomonitoring Indoor Air & Dust CA Air Resources Board Journal Articles Drinking Water NHANES & Danish Birth Cohort Journal Articles EPA drinking water standards Journal Articles Consumer Products Primarily Danish and Dutch consumer product studies

Separated chemicals found in childrens products from those found in general consumer products 11 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/advanced Environmental Health Perspectives: http://www.ehponline.org/ Toxicological Sciences: http://toxsci.oxfordjournals.org/search.dtl Biomonitoring: Adipose Blood Breast milk Cord serum Human Infant Tissue Urine Biomonitoring Blood level Cord blood Placenta Human Exposure Infant Exposure Maternal blood Exposure

General: Children Child Indoor Air & Dust Indoor Air Dust House Home Indoor Drinking water: Drinking water Public water Water supply Water Products: Consumer products Toys Product Products 12 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 Dont 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 Exposure Chemical Results Exposure Information Source Biomonitoring Studies Drinking Water Indoor Air and House Dust Consumer Products Number of Chemicals 280 239 290 1,798 2,607 Total 2,419 Unique (sum) 2,219 Unique (CAS) 14 15 Phase 2

Governors veto message directed Ecology to place greater emphasis upon chemicals found in childrens products Prioritized products based upon 3 toxicity criteria of most importance to children and presence in childrens products Used a weight-of-evidence approach 16 Phase 2 (cont.) Chemicals removed before further prioritization: 476 178 17 Phase 2 (cont.) Toxicity criteria I. Developmental or reproductive toxicity Evidence of high toxicity concerns for ANY endpoints (I, II III)? Yes Worst II. Endocrine Disruption No* Evidence of

moderate toxicity concerns for ANY endpoints (I, II, III)? III. Carcinogenicity No* Evidence of low toxicity concerns for ANY endpoints (I, II, III)? Yes Yes Severe Bad No* NI * Includes unable to classify Process created by Catherine Karr, MD, PhD, Dept. of Pediatrics and Dept. Environmental & Occupational Health Sciences, University of Washington 18 Phase 2 (cont.) I.

Developmental or Reproductive Toxicity 1. Prop 65 Identified as developmental toxicant NTP CERHR finding Clear or some evidence of adverse effects in humans Limited evidence in humans or some evidence in animals Limited evidence in animals Some or clear evidence of no observable adverse effects EU Existing Substances Identified as Category 1, 2 or 3 GHS Identified as Category 1A, 1B or 2 for reproductive toxicity or germ cell mutagenicity REPROTEXT Rated as A+, A, A-, B+, B, B-, C, D, E, F LOAEL or RTECS TDLo or TCLo Oral value (mg/kg-bw/day) Dermal value (mg/kg-bw/day) Inhalation (vapor) value (mg/L/day) Inhalation (dust/mist/fume) value (mg/L/day) Inhalation (gas) value (ppm/day) 2. 3. 4. 5. 6. Worst Severe

Bad Yes No No Info No NI Value or Comment Yes Yes Yes Yes Cat 1 Cat 2 Cat 3 NI Cat 1A Cat 1B Cat 2 NI A+, A

A-, B+ B < 50 < 100 < 1.0 < 0.1 < 50 50 - 250 100 - 500 1.0 - 2.5 0.1 - 0.5 50 - 250 > 250 > 500 > 2.5 > 0.5 > 250 E, F B-, C, D NI NI NI NI NI 19 Phase 2 (cont.) I. Evidence suggests presence of this chemical in childrens products

Exposure Criteria Known Unlikely II. Evidence suggests concern for individual child exposure from product with this chemical Known Middle Top Priority Top Priority No Change Process created by Catherine Karr, MD, PhD, Dept. of Pediatrics and Dept. Environmental & Occupational Health Sciences, University of Washington Possible Possible Unlikely Top Middle Priority Middle Low Priority

III. Evidence suggests concern for widespread population level exposure to this chemical Known Possible Unlikely Top No Priority change Top Middle Priority Middle Top Priority Middle Lowest Priority Lowest Middle Priority Lowest No Priority 20 Phase 2 (cont.) I. Presence in a child product Known Possible Unlikely

No Value or No Info Comment 14. Found in Danish EPA or Dutch studies and reports Yes NI 15. EU or authoritative Risk Assessment indicating use in childrens products Yes NI 16. Evidence in data in HSDB indicating possible use in childrens products Yes NI 17. Environmental Working Group database if used in cosmetics or sunscreens Yes NI 18. EPAs Inventory Use and Reporting database (IUR) Yes NI

19. NLM Household products database Yes NI 21 Phase 2 (cont.) Segregated 178 potential CHCCs into the following bins Exposure T o x Known Possible Unlikely Worst WK WP WU Severe SK SP

SU Bad BK BP BU Reduced 178 potential CHCCs to 65 22 50-00-0 57-55-6 60-29-7 62-53-3 62-75-9 71-36-3 71-43-2 75-01-4 75-07-0 75-09-2 75-15-0 78-93-3 79-34-5 79-94-7 80-05-7 84-66-2 84-75-3 85-44-9 86-30-6 87-68-3 94-13-3 94-26-8 95-53-4 95-80-7

99-76-3 99-96-7 100-414 100-425 104-405 106-478 107-13- Formaldehyde Propylene glycol Diethyl ether Aniline N-nitrosodimethylamine 1-Butanol Benzene Vinyl chloride Acetaldehyde Methylene chloride Carbon disulfide Methyl ethyl ketone 1,1,2,2-Tetrachloroethane TBBPA; Tetrabromobisphenol A Bisphenol A DEP; Diethyl phthalate di-n-hexylphthalate Phthalic anhydride N-nitroso-diphenylamine Hexachlorobutadiene n-Propyl paraben Butyl paraben 2-Aminotoluene 2,4-Toluenediamine Methyl paraben 4-Hydroxybenzoic acid 108-88-3 Toluene

108-95-2 Phenol 109-86-4 2-Methoxyethanol 110-80-5 Ethylene glycol monoethyl ester 115-96-8 TCE; Tris-(2-chlorethyl)-phosphate 118-74-1 Hexachlorobenzene; HCB 119-93-7 3,3- Dimethylbenzidine 120-47-8 Ethyl paraben 123-91-1 1,4-Dioxane 127-18-4 Perchloroethylene; Tetrachlorethylene 131-11-3 Dimethyl phthalate 131-55-5 Benzophenone-2 140-66-9 4-tert-Octylphenol 140-67-0 Estragole 149-57-5 2-Ethyl hexanoic acid 556-67-2 Octamethylcyclotetrasiloxane 608-93-5 PeCB; pentachlorobenzene 842-07-9 C.I. Solvent Yellow 14 872-50-4 1-Methyl-2-pyrrolidinon; NMP 1163-19-5

BDE 209; Deca-BDE 1763-23-1 PFOS 1806-26-4 4-Octylphenol 4376-20-9 MEHP; Mono-2-ethylhexyl phthalate 5466-77-3 2-Ethylhexyl-p-methoxycinnamate 7439-97-6 Mercury & mercury compounds 7439-98-7 Molybdenum & Molybdenum compounds Ethyl benzene 7440-36-0 Antimony & Antimony compounds Styrene 7440-38-2 Arsenic & Arsenic compounds 4-n-Nonylphenol; n-NP 7440-41-7 Beryllium & Beryllium compounds Chloroaniline 7440-48-4 Cobalt & Cobalt compounds 25013-16- 23 Butylated Hydroxyanisole; BHA Acrylonitrile 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 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 Links Children Safe Product Act & Pilot Rule Process: http://www.ecy.wa.gov/programs/swfa/rules/ ruleChildSafePilot.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&_docanchor=&view=c&_acct=C000050 221&_version=1&_urlVersion=0&_userid=1 0&md5=6cbd6a426cb849743c8d27f7da88326 Contacts Alex Stone Safer Chemical Alternative Chemist Washington State Dept. of Ecology [email protected] Phone: (360) 407-6758 27

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