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 Ecologyalex.stone@ecy.wa.govPhone: (360) 407-6758

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