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Rationale for Identification of Carcinogens for the NSF/UL 440 Health-based Emissions Project Purpose: To review the selection criteria for carcinogenic chemicals to be included in the NSF/UL 440 standard.

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  1. Rationale for Identification of Carcinogens for the NSF/UL 440 Health-based Emissions ProjectPurpose: To review the selection criteria for carcinogenic chemicals to be included in the NSF/UL 440 standard The comments expressed in this presentation may or may not reflect the views of the CPSC staff as a whole and the Commission Draft, Deliberate, and Confidential

  2. Step 1 – Identify organizations that have transparent and robust qualitative classifications of chemical carcinogens • Why? • So that the standard requests analysis of chemicals that are only known as or have a high probability of being a carcinogen • CA 1350 “Target VOCs” (Section 4.1.2) “include knownor probablehuman carcinogens…” • CA 1350 draws upon a list of known or probable human carcinogens…” presented in the Safe Drinking Water and Toxic Enforcement Act of 1986 (Proposition 65)for some of its “Target VOCs” • Tier 1 organizations (highest transparency and credible science) • EPA • NTP • IARC • Tier 2 organizations (lesser transparency/methodological familiarity) • OEHHA proposition 65 listings • NIOSH Draft, Deliberate, and Confidential

  3. Step 2 – Determine the classifications that have appropriate levels of evidence • Tier 1 • EPA (http://www.epa.gov/iris/) • 2005 - Carcinogenic to Humans • 2005 - Likely to be Carcinogenic to Humans • 1999 - Carcinogenic to Humans • 1999 - Likely to be Carcinogenic in Humans • 1996 - Known/Likely Human Carcinogen • 1986 - Group A - (Human Carcinogen) • 1986 - Group B1 - (Probable Human Carcinogen; Limited evidence of carcinogenicity in humans and sufficient evidence of carcinogenicity in animals) • 1986 - Group B2 - (Probable human carcinogen; Sufficient evidence of carcinogenicity in animals) • NTP (http://ntp.niehs.nih.gov/?objectid=03C9AF75-E1BF-FF40-DBA9EC0928DF8B15) • Known to be a Human Carcinogen • Reasonably Anticipated to be Human Carcinogen • IARC (http://monographs.iarc.fr/ENG/Classification/index.php) • Group 1 – (Carcinogenic to humans; Sufficient evidence in humans or sufficient evidence in animals and strong mechanistic data in humans) • Group 2A – (Probably carcinogenic to human; Limited evidence in humans and sufficient evidence in animals) Draft, Deliberate, and Confidential

  4. Step 2 con’t– Do any other classification systems/organizations have appropriate levels of evidence? • Tier 2 • OEHHA Proposition 65 list chemicals • “Cancer” • (http://oehha.ca.gov/prop65/prop65_list/files/P65single052413.pdf) • NIOSH • “Potential Occupational Carcinogen” • (http://www.cdc.gov/niosh/topics/cancer/npotocca.html) Draft, Deliberate, and Confidential

  5. Step 3 – Compile ALL substances that correspond to these qualitative classifications • EPA (104 substances and chemicals) • 1986 – Group A - 12, B1 - 5, B2 - 61; • 1996 – 8 • 1999 – Carc. to Hum. – 1; Likely – 4 • 2005 – Carc. to Hum. – 1; Likely – 12 • NTP (240 substances and chemicals) • Known – 54 • Reasonable – 186 • IARC (176 substances and chemicals) • Group 1 – 111 • Group 2A – 65 • OEHHA Proposition 65 (554 substances and chemicals) • “Cancer” – 554 • NIOSH (132 substances and chemicals) • “Potential Occupational Carcinogen” - 132 Draft, Deliberate, and Confidential

  6. Step 4 – Remove substances from the lists that are not within scope of NSF/UL 440: • Biologicalssuch as bacteria and viruses • Food substances • Exposures to mixtures resultant from food preparation • Particulates • Radionuclides • Complex compositions such as wood smoke, diesel fuel, etc • Occupational chemical exposures • Medications and pharmaceuticals • Metals • Groupings of substances or chemicals without a defined CAS Draft, Deliberate, and Confidential

  7. Step 5 – Remove substances that are outside the volatility range specified by CA 1350 (0.000227 – 514.1 mm Hg at 25C) CA 1350 defines a VOC as: Draft, Deliberate, and Confidential

  8. Chemicals Excluded on the Basis of Volatility Blue = on Al’s list, Green = on HPDB Draft, Deliberate, and Confidential

  9. Step 6 – Remove chemicals that:1) are not on Al Hodgson’s 061212 spreadsheet2) are not a chemical componentin building products or furnishings listed in the Household Products Databaseor 3) do not have a cancer TRV Draft, Deliberate, and Confidential

  10. Step 7– Identify the Inhalation Unit Risks for the remaining chemicals Draft, Deliberate, and Confidential

  11. List of Carcinogenic Chemicals from EPA • EPA (Tier 1) – 10 out of 104 • plus 5 not found in HPDB or as an emission on Al’s spreadsheet • Blue = on Al’s list, Green = on HPDB Draft, Deliberate, and Confidential

  12. List of Carcinogenic Chemicals from NTP • NTP (Tier 1) – 13 out of 240 • plus 5 not found in HPDB or as an emission on Al’s spreadsheet • Blue = on Al’s list, Green = on HPDB Draft, Deliberate, and Confidential

  13. List of Carcinogenic Chemicals from IARC • IARC (Tier 1) – 5 out of 176 • plus 2 not found in HPDB or as an emission on Al’s spreadsheet • Blue = on Al’s list, Green = on HPDB Draft, Deliberate, and Confidential

  14. Combined List of Chemicals from EPA, NTP, IARC • EPA, NTP, and IARC (Tier 1) – 14 total • plus 5 chemicals not found in HPDB or as an emission on Al’s spreadsheet • Blue = on Al’s list, Green = on HPDB Draft, Deliberate, and Confidential

  15. List of Carcinogenic Chemicals Derived from OEHHA Proposition 65 Listings (if not already considered in Tier 1 list) • OEHHA proposition 65 list (Tier 2) – 10 out of 554 • Plus 1 chemical not found in HPDB or as an emission on Al’s spreadsheet • Blue field = found as a product emission on Al’s spreadsheet • Light Green field = found in HPDB • Orange cell = found in HPDB in a product that MAY be associated with building products or furnishings • NIOSH (Tier 2) – 0 out of 132 Draft, Deliberate, and Confidential

  16. Should we include the chemicals from the Tier 2 organizations? • CA 1350 draws from the Proposition 65 list for some of its target VOCs (“known or probable human carcinogens and reproductive/developmental toxins”) • Methylisobutyl ketone, ethylbenzene, 1,3 DCP, and isopropyl benzene in Al’s list of chemicals emitted from building products or furnishings • Diethanolamine and ethylacrylate listed as components in building products (HPDB) • Benzophenone, benzaldehyde, and cyclohexanone emitted from the UV-cured lacquer of French coated oak parquet flooring (Formation of organic indoor air pollutants by UV-curing chemistry. Salthammer, T.; Bednarek, M.; Fuhrmann, F.; Funaki, R.; Tanabe, S.-I. Journal of Photochemistry and Photobiology A: Chemistry vol. 152 issue 1-3 September 20, 2002. p. 1-9; in addition to the Prop 65 listing, benzaldehyde has some evidence of cancer in mice studies and cancer cluster in Ohio, NTP study of Benzoph. Was done via oral ingestion) • Propylene glycol mono-t-butyl ether used in water-based paints (Choi et al, 2010), in adhesives, and in water-reducible coatings (NTP, 2004) • Cocamidediethanolamine primarily used in personal care products (shampoos, hand soaps, and cosmetics), so delete? • o-polyphenol used primarily as a fungicide or germicide in fruits and vegetables, so delete? • Hydrazine in rocket and other fuels, not in building products, so delete? Draft, Deliberate, and Confidential

  17. Final list of 29? Chemicals combiningTier 1, Tier 2, and Aldehydes(* indicates that a cancer unit risk does not exist) Draft, Deliberate, and Confidential

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