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This document outlines the rationale and steps for identifying carcinogenic chemicals as part of the NSF/UL.440 standard. It highlights the importance of using transparent and robust classifications from credible organizations such as the EPA, NTP, and IARC. The process involves multiple steps, including the compilation of substances based on established criteria, removal of irrelevant chemicals, and identification of inhalation unit risks. Ensuring that the standard addresses only chemicals with a high probability of carcinogenicity is crucial for public health and safety.
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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
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
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
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
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
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
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
Chemicals Excluded on the Basis of Volatility Blue = on Al’s list, Green = on HPDB Draft, Deliberate, and Confidential
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
Step 7– Identify the Inhalation Unit Risks for the remaining chemicals Draft, Deliberate, and Confidential
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
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
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
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
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
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
Final list of 29? Chemicals combiningTier 1, Tier 2, and Aldehydes(* indicates that a cancer unit risk does not exist) Draft, Deliberate, and Confidential