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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.

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Presentation on theme: "Rationale for Identification of Carcinogens for the NSF/UL 440 Health-based Emissions Project Purpose: To review the selection criteria for carcinogenic."— Presentation transcript:

1 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 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 known or probable human 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/)http://www.epa.gov/iris/ Carcinogenic to Humans Likely to be Carcinogenic to Humans Carcinogenic to Humans Likely to be Carcinogenic in Humans Known/Likely Human Carcinogen Group A - (Human Carcinogen) Group B1 - (Probable Human Carcinogen; Limited evidence of carcinogenicity in humans and sufficient evidence of carcinogenicity in animals) Group B2 - (Probable human carcinogen; Sufficient evidence of carcinogenicity in animals) – NTP (http://ntp.niehs.nih.gov/?objectid=03C9AF75-E1BF-FF40-DBA9EC0928DF8B15)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)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 cont – 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/P65single pdf)http://oehha.ca.gov/prop65/prop65_list/files/P65single pdf – NIOSH Potential Occupational Carcinogen (http://www.cdc.gov/niosh/topics/cancer/npotocca.html)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 Draft, Deliberate, and Confidential

6 Step 4 – Remove substances from the lists that are not within scope of NSF/UL 440: Biologicals such 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 ( – mm Hg at 25C) CA 1350 defines a VOC as: Draft, Deliberate, and Confidential

8 Chemicals Excluded on the Basis of Volatility Blue = on Als list, Green = on HPDB Draft, Deliberate, and Confidential

9 Step 6 – Remove chemicals that: 1) are not on Al Hodgsons spreadsheet 2) are not a chemical component in building products or furnishings listed in the Household Products Database or 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 Als spreadsheet Blue = on Als 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 Als spreadsheet Blue = on Als 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 Als spreadsheet Blue = on Als 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 Als spreadsheet Blue = on Als 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 Als spreadsheet – Blue field = found as a product emission on Als 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 Als 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, 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) Cocamide diethanolamine 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 combining Tier 1, Tier 2, and Aldehydes (* indicates that a cancer unit risk does not exist) Draft, Deliberate, and Confidential


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