alex stone, sc. d. safer chemical alternative chemist wa dept. of ecology exposure science community...
TRANSCRIPT
Selection and Prioritization of Chemicals for WA’s Children’s Safe
Product Act (CSPA)
Alex Stone, Sc. D.Safer Chemical Alternative Chemist
WA Dept. of Ecology
Exposure Science Community of Practice TeleconferenceMay 11, 2010
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BackgroundMassive recall of toys in 2007 for high lead levelsOne child died from swallowing lead charmConcerns 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 productsRequired 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
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Background (cont.)
Federal Consumer Product Safety Improvement Act passed in August 2008Preempted state legislationEstablished less restrictive limits for lead and
phthalates
Ecology determined CSPA reporting requirements not preempted by federal legislation
Continued with process for identifying CHCCs
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CSPA ImplementationThree Phases
1. Identification of Chemicals of High Concern to Children (CHCCs)
2. Prioritization of CHCCs3. Final review and determination of CHCCs
to be placed into regulation
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Phase 1Identify High Priority Chemicals (HPC)Identify Chemicals in Potential Exposure
SourcesIdentify Chemicals of High Concern to
Children (CHCCs), i. e. chemicals that are:1. An HPC and2. 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 toxinb) Cause:
• Cancer• Genetic damage• Reproductive harm• Endocrine disruptor
c) Damage:• Nervous system• Immune system• Organs• Other systemic toxicity
d) PBTe) vPvB (very persistent & very bioaccumulative)
HPCs
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HPC Sources:United States: Federal United States: State
Prop 65-Total 721EPA TRI PBT Chemicals 64 Prop 65 Cancer 509EPA VCCEP 23 Prop 65 Developmental 256Nat. Waste Min. Program Priority Chem. 33 Prop 65 Female 42National Toxicology Program Reproduction 39 Prop 65 Male 60National Tox. Program Carcinogens-Known 55 WA PBTs 74
National Tox. Program Carcinogens-Suspected 181 International: EuropeIRIS 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 Carcinogens 4 OSPAR 1997 Chemicals for Priority Action 35
IRIS 2005 Suggestive Evidence 1 IARC Group 1 Known Carcinogens 47
IRIS Other 423 IARC Group 2a Probable Carcinogens 52IARC Group 2b Possible Carcinogens 222
Other International: CanadaGrandjean Neuro/developmental toxicants 201 Canadian PBiT list 393
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Primary Toxicity Criteria Source of Information Nr. of HPCsCarcinogenicity Prop 65 446
NWMP 8IARC 321IRIS 138NTP 238
DNR toxicity (dev., neurodev. & Prop 65 414 repro. toxicity) VCCEP 23
Grandjean and Landrigan (2006) 202NTP 39
CMR toxicity NWMP 20ESR 141SVHC 10
Endocrine disruption EU ED 317OSPAR 22
PBT CEPA PBiT 393TRI 72NWMP 5EU PBT 61SVHC 5OSPAR 336WA PBT 75
vPvB SVHC 1
Other (systemic, target organ, etc.) IRIS 423
3710 Total (sum)2160 Unique (sum)2044 Unique (CAS)
HPC Sources: (cont.)
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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
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
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
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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/advancedEnvironmental Health Perspectives: http://www.ehponline.org/Toxicological Sciences: http://toxsci.oxfordjournals.org/search.dtl
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Biomonitoring: Adipose Biomonitoring Blood Blood level Breast milk Cord blood Cord serum Placenta Human Human Exposure Infant Infant Exposure Tissue Maternal blood Urine 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
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
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Exposure Information Source Number of Chemicals
Biomonitoring Studies 280Drinking Water 239Indoor Air and House Dust 290Consumer Products 1,798
2,607 Total
2,419 Unique (sum)
2,219 Unique (CAS)
Exposure Chemical Results
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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
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Phase 2 (cont.)
Chemicals removed before further prioritization:
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178
476
Phase 2 (cont.)Toxicity criteria
Process created by Catherine Karr, MD, PhD, Dept. of Pediatrics and Dept. Environmental & Occupational Health Sciences, University of Washington
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I. Developmental or reproductive toxicity
III. Carcinogenicity II. Endocrine Disruption
Evidence of high toxicity concerns for ANY endpoints (I, II III)?
Evidence of moderate toxicity concerns for ANY endpoints (I, II, III)?
Evidence of low toxicity concerns for ANY endpoints (I, II, III)?
Worst Severe Bad NI
No*No*No*
Yes YesYes
* Includes unable to classify
Phase 2 (cont.)
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I. Developmental or Reproductive ToxicityWorst Severe Bad No
NoInfo
Value orComment
1. Prop 65
Identified as developmental toxicant Yes No NI
2. NTP CERHR finding
Clear or some evidence of adverse effects in humans Yes
Limited evidence in humans or some evidence in animals Yes
Limited evidence in animals YesSome or clear evidence of no observable adverse effects Yes
3. EU Existing Substances
Identified as Category 1, 2 or 3 Cat 1 Cat 2 Cat 3 NI4. GHS
Identified as Category 1A, 1B or 2 for reproductive toxicity or germ cell mutagenicity
Cat 1A Cat 1B Cat 2 NI
5. REPROTEXT
Rated as A+, A, A-, B+, B, B-, C, D, E, F A+, A A-, B+ B E, F B-, C, D
6. LOAEL or RTECS TDLo or TCLo
Oral value (mg/kg-bw/day) < 50 ≥ 50 - ≤ 250 > 250 NI
Dermal value (mg/kg-bw/day) < 100 ≥ 100 - ≤ 500 > 500 NI
Inhalation (vapor) value (mg/L/day) < 1.0 ≥ 1.0 - ≤ 2.5 > 2.5 NI
Inhalation (dust/mist/fume) value (mg/L/day) < 0.1 ≥ 0.1 - ≤ 0.5 > 0.5 NI
Inhalation (gas) value (ppm/day) < 50 ≥ 50 - ≤ 250 > 250 NI
Phase 2 (cont.)ExposureCriteria
Process created by Catherine Karr, MD, PhD, Dept. of Pediatrics and Dept. Environmental & Occupational Health Sciences, University of Washington
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I. Evidence suggests presence of this chemical in children’s products
Known UnlikelyPossible
II. Evidence suggests concern for individual child exposure from product with this chemical
Known UnlikelyPossible
Middle →Top Priority
Top Priority →No Change
Top →Middle Priority
Middle →Low Priority
III. Evidence suggests concern for widespread population level exposure to this chemical
Known UnlikelyPossible
Top →No Priority change
Middle →Top Priority
Lowest →Middle Priority
Top →Middle Priority
Middle →Lowest Priority
Lowest →No Priority
Phase 2 (cont.)
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I. Presence in a child productKnown Possible Unlikely No
NoInfo
Value orComment
14. Found in Danish EPA or Dutch studies and reports Yes NI
15. EU or authoritative Risk Assessment indicating use in children’s products
Yes NI
16. Evidence in data in HSDB indicating possible use in children’s products
Yes NI
17. Environmental Working Group database if used in cosmetics or sunscreens
Yes NI
18. EPA’s Inventory Use and Reporting database (IUR) Yes NI
19. NLM Household products database Yes NI
Phase 2 (cont.)
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Exposure
Known UnlikelyPossible
WK WUWP
SK SUSP
BK BUBP
Worst
Severe
Bad
Tox
Segregated 178 potential CHCCs into the following ‘bins’
Reduced 178 potential CHCCs to 65
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50-00-0 Formaldehyde 108-88-3 Toluene57-55-6 Propylene glycol 108-95-2 Phenol60-29-7 Diethyl ether 109-86-4 2-Methoxyethanol62-53-3 Aniline 110-80-5 Ethylene glycol monoethyl ester62-75-9 N-nitrosodimethylamine 115-96-8 TCE; Tris-(2-chlorethyl)-phosphate71-36-3 1-Butanol 118-74-1 Hexachlorobenzene; HCB71-43-2 Benzene 119-93-7 3,3’- Dimethylbenzidine75-01-4 Vinyl chloride 120-47-8 Ethyl paraben75-07-0 Acetaldehyde 123-91-1 1,4-Dioxane75-09-2 Methylene chloride 127-18-4 Perchloroethylene; Tetrachlorethylene75-15-0 Carbon disulfide 131-11-3 Dimethyl phthalate78-93-3 Methyl ethyl ketone 131-55-5 Benzophenone-279-34-5 1,1,2,2-Tetrachloroethane 140-66-9 4-tert-Octylphenol79-94-7 TBBPA; Tetrabromobisphenol A 140-67-0 Estragole80-05-7 Bisphenol A 149-57-5 2-Ethyl hexanoic acid84-66-2 DEP; Diethyl phthalate 556-67-2 Octamethylcyclotetrasiloxane84-75-3 di-n-hexylphthalate 608-93-5 PeCB; pentachlorobenzene85-44-9 Phthalic anhydride 842-07-9 C.I. Solvent Yellow 1486-30-6 N-nitroso-diphenylamine 872-50-4 1-Methyl-2-pyrrolidinon; NMP87-68-3 Hexachlorobutadiene 1163-19-5 BDE 209; Deca-BDE94-13-3 n-Propyl paraben 1763-23-1 PFOS94-26-8 Butyl paraben 1806-26-4 4-Octylphenol95-53-4 2-Aminotoluene 4376-20-9 MEHP; Mono-2-ethylhexyl phthalate95-80-7 2,4-Toluenediamine 5466-77-3 2-Ethylhexyl-p-methoxycinnamate99-76-3 Methyl paraben 7439-97-6 Mercury & mercury compounds99-96-7 4-Hydroxybenzoic acid 7439-98-7 Molybdenum & Molybdenum compounds100-41-
4Ethyl benzene 7440-36-0 Antimony & Antimony compounds
100-42-5
Styrene 7440-38-2 Arsenic & Arsenic compounds
104-40-5
4-n-Nonylphenol; n-NP 7440-41-7 Beryllium & Beryllium compounds
106-47-8
Chloroaniline 7440-48-4 Cobalt & Cobalt compounds
107-13-1
Acrylonitrile25013-16-
5Butylated Hydroxyanisole; BHA
107-21-1
1,2-Ethandiol; Ethylene glycol25154-52-
3Nonylphenol
25637-99-4
HBCD; Hexabromocyclododecane
Phase 3Final review of 65 CHCCs to determine those placed
into regulation
Four components part of final determination:1. Final toxicity and exposure review2. Determination of a reasonable analytical
method3. Determination of a reporting level4. Overall policy review
In the meantime conducting Pilot Rule
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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
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LinksChildren 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=C000050221&_version=1&_urlVersion=0&_userid=10&md5=6cbd6a426cb849743c8d27f7da883874
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ContactsAlex StoneSafer Chemical Alternative ChemistWashington State Dept. of [email protected]: (360) 407-6758
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