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Regulatory Actions for Year 2015

Year Agency Title CASRN
2015 EPA
Addition of 1-Bromopropane; Community Right-to-Know Toxic Chemical Release Reporting

The Environmental Protection Agency (EPA) is adding 1-bromopropane to the list of toxic chemicals subject to reporting under section 313 of the Emergency Planning and Community Right-to-Know Act (EPCRA) of 1986 and section 6607 of the Pollution Prevention Act (PPA) of 1990. 1-Bromopropane has been classified by the National Toxicology Program in their 13th Report on Carcinogens as ‘‘reasonably anticipated to be a human carcinogen.’’ The EPA has determined that 1-bromopropane meets the EPCRA section 313(d)(2)(B) criteria because it can reasonably be anticipated to cause cancer in humans.

NTP Information Cited
NTP, 2014. National Toxicology Program. Report on Carcinogens, Thirteenth Edition. Released October 2, 2015. U.S. Department of Health and Human Services, Public Health Service, National Toxicology Program, Research Triangle Park, NC 27709.

NTP, 2013. Report on Carcinogens Monograph on 1-Bromopropane.  Office of the Report on Carcinogens, Division of the National Toxicology Program, National Institute of Environmental Health Sciences, U.S. Department of Health and Human Services.  NIH Publication No. 13-5982, September 25, 2013

  • Type: Final Rule
  • November 23, 2015
  • 80 FR 72906
106–94–5
2015 OEHHA
Notice of Intent to List Pentachlorophenol and By-Products of Its Synthesis (Complex Mixture)

The California Environmental Protection Agency’s Office of Environmental Health Hazard Assessment (OEHHA) intends to list “pentachlorophenol and by-products of its synthesis (complex mixture)” as known to the state to cause cancer under the Safe Drinking Water and Toxic Enforcement Act of 1986.

NTP Information Cited
“The combined incidence of benign and malignant liver tumors (hepatocellular adenoma and carcinoma) was significantly increased in mice of both sexes following dietary exposure to Dowicide EC-74 and in males following exposure to technical-grade pentachlorophenol. In males exposed to either formulation, the separate incidence of malignant liver tumors also was significantly increased” (footnote not in original).

“The incidences of benign and malignant adrenal-gland tumors (pheochromocytoma) combined, benign adrenal-gland tumors, and preneoplastic adrenal-gland lesions (medullary hyperplasia) were significantly increased in mice of both sexes exposed to Dowicide EC-7.”

“The incidence of malignant tumors of the blood vessels (hemangiosarcoma) of the spleen and/or liver was significantly increased in female mice exposed to technical-grade pentachlorophenol or Dowicide EC-7.”

“In male F344 rats (Chhabra et al. 1999, NTP 1999), increased incidences of tumors were observed in the tunica vaginalis of the testes and in the nose. In a stop-exposure study, the incidence of malignant mesothelioma of the tunica vaginalis was significantly increased after dietary exposure to 99% pure pentachlorophenol for one year, followed by one year of observation. Although the increased incidence of squamous-cell carcinoma of the nose was not statistically significant, this is a rare tumor, and its incidence exceeded the range for historical controls.”

NTP (2014). Report on Carcinogens, Thirteenth Edition, U.S. Department of Health and Human Services, Public Health Service, NTP, Research Triangle Park, North Carolina. 

  • Type: Notice
  • October 30, 2015
  • Proposition 65
87-86-5
2015 EPA
Ethylene Glycol Monobutyl Ether; Community Right-To-Know Toxic Chemical Release Reporting

Environmental Protection Agency (EPA) is denying a petition to remove ethylene glycol monobutyl ether (EGBE) from the category Certain Glycol Ethers under the list of chemicals subject to reporting under section 313 of the Emergency Planning and Community Right-to-Know Act (EPCRA) of 1986 and section 6607 of the Pollution Prevention Act (PPA) of 1990. EPA has reviewed the available data on this chemical and has determined that EGBE does not meet the deletion criterion of EPCRA section 313(d)(3). Specifically, EPA is denying this petition because EPA’s review of the petition and available information resulted in the conclusion that EGBE meets the listing criterion of EPCRA section 313(d)(2)(B) due to its potential to cause serious or irreversible chronic health effects in humans, specifically, liver toxicity and concerns for hematological effects.

NTP Information Cited
NTP. 2000. NTP technical report on the toxicology and carcinogenesis studies of 2- butoxyethanol (CAS No. 111–76–2) in F344/N rats and B6C3F1 mice (inhalation studies). National Toxicology Program. Research Triangle Park, NC. NTP TR 484. https://ntp.niehs.nih.gov/results/pubs/longterm/reports/longterm/tr400499/abstracts/tr484/index.html.  

 

NTP. 1996. Toxicology and carcinogenesis studies of acetonitrile (CAS No 75–05–8) in F344/N rats and B6C3F1 mice (inhalation studies). National Toxicology Program. Research Triangle Park, NC. 

 

NTP. 1993. NTP technical report on toxicity studies of ethylene glycol ethers: 2-methoxyethanol, 2-ethoxyethanol, 2-butoxyethanol (CAS Nos. 109–86–4, 110–80–5, 111–76–2) administered in drinking water to F344/N rats and B6C3F1 mice. National Toxicology Program. Research Triangle Park, NC. 26; NIH Publication 93–3349.

  • Type: Denial of Petition
  • October 08, 2015
  • 80 FR 60818
98-01-1
98-00-0
110-00-9
2015 OEHHA
Prioritization: Chemicals for Consultation by the Developmental and Reproductive Toxicant Identification Committee

This notice announces the beginning of a 45-day public comment period on the five chemicals listed below. These chemicals will be discussed at the November 9, 2015 meeting of the Proposition 65 Developmental and Reproductive Toxicant Identification Committee (DARTIC). The five chemicals are: • Nickel • Pentachlorophenol • Perfluorooctanoic acid (PFOA) • Perfluorooctane sulfonate (PFOS) • Tetrachloroethylene

NTP Information Cited
NTP, Report on Carcinogens

  • Type: Notice
  • August 28, 2015
  • Proposition 65
7440-02-0
2015 OEHHA
Availability of Hazard Identification Materials For Nitrapyrin And Di­lamino­toluenes. "Di­lamino­toluene (Mixed)" And Nitrapyrin Are Under Review For Possible Delisting

OEHHA is referring nitrapyrin and di­lamino­toluene (mixed) to the Carcinogen Identification Committee (CIC), the state’s qualified experts for carcinogenicity determinations under Proposition 65, for review.

NTP Information Cited
The NTP is mandated to provide to Congress an annual report on carcinogens. The last report was provided in October, 2014 (Exhibit). In this report 2,5-di­lamino­toluene was not listed as either a known human carcinogen, or a chemical suspected of being a human carcinogen.

Note that no stomach tumors were found in the 2-year NTP study in the same species.] may confirm the lack of genotoxic activity of toluene-2,5-diamine sulfate in vivo.

National Toxicology Program, NTP Technical Report on the Toxicology and Carcinogenesis Studies of Two Pentachlorophenol Technical-Grade Mixtures in B6C3Fl Mice, NTP TR 349, NIH Publication No. 89-2804,
March, 1989.

NTP provided historical control data (updated in 1999) for testicular tumors  (currently termed testicular adenoma) among 20 NCI/NTP dietary carcinogenicity studies in male Fischer 344 rats given the NIH-07 diet (the same diet used for the study of 2,5-di­lamino­toluene).

Ashby J and Tennant RW (1988). Chemical structure, Salmonella mutagenicity and extent of carcinogenicity as indicators of genotoxic carcinogenesis among 222 chemicals tested in rodents by the U.S. NCI/NTP. Mutat Res 204 (1): 17-115.

National Cancer Institute (1978) Bioassay of 2,5-Toluenediamine Sulfate for Possible Carcinogenicity (CAS No. 6369-59-1) NCI-GG-TR-126.

  • Type: Notice
  • August 28, 2015
  • Proposition 65
95-80-7
6369-59-1
2015 OSHA
Occupational Exposure to Beryllium and Beryllium Compounds

The Occupational Safety and Health Administration (OSHA) proposes to amend its existing exposure limits for occupational exposure in general industry to beryllium and beryllium compounds and promulgate a substance-specific standard for general industry regulating occupational exposure to beryllium and beryllium compounds. This document proposes a new permissible exposure limit (PEL), as well as ancillary provisions for employee protection such as methods for controlling exposure, respiratory protection, medical surveillance, hazard communication, and recordkeeping. In addition, OSHA seeks comment on a number of alternatives, including a lower PEL, that could affect construction and maritime, as well as general industry.

NTP Information Cited
In brief, IARC determined beryllium and its compounds to be carcinogenic to humans (Group 1 category), while EPA considers beryllium to be a probable human carcinogen (EPA, 1998), and the National Toxicology Program (NTP) has determined beryllium and its compounds to be known carcinogens (NTP, 2014).

 

Other scientific organizations, including the International Agency for Research on Cancer (IARC), the National Toxicology Program (NTP), the U.S. Environmental Protection Agency (EPA), the National Institute for Occupational Safety and Health (NIOSH), and the American Conference of Governmental Industrial Hygienists (ACGIH) have reached similar conclusions with respect to the carcinogenicity of beryllium

 

National Toxicology Program. (1993). Toxicology and Carcinogenesis Studies of Talc (CAS No. 14807–96–6)(NonAsbestiform) in F344/N Rats and B6C3F1 Mice (Inhalation Studies).

 

National Toxicology Program. (1999). Final Report on Carcinogens: Background Document for Beryllium and Beryllium Compounds. 

 

National Toxicology Program. (2002). Tenth report on carcinogens. U.S. Department of Health and Human Services, National Toxicology Program, Research Triangle Park, NC. 

National Toxicology Program. (2014). Report on Carcinogens, Thirteenth Edition. Beryllium and Beryllium compounds. CAS No. 7440–41–7.

  • Type: Proposed rule; Request for Comments
  • August 07, 2015
  • 80 FR 47566
14807-96-6
7440-41-7
2015 OEHHA
Notice of Intent to List Furfuryl Alcohol

The California Environmental Protection Agency’s Office of Environmental Health Hazard Assessment (OEHHA) intends to list furfuryl alcohol as known to the state to cause cancer under the Safe Drinking Water and Toxic Enforcement Act of 1986

NTP Information Cited
NTP (National Toxicology Program).  1990.  NTP Technical Report on the Toxicology and Carcinogenesis Studies of Furfural (CAS No. 98-01-1) in F344/N rats and B6C3F1 mice (Gavage Studies). NTP-TR-382, MRID 46011016.

National Toxicology Program (NTP). 1999. NTP Technical Report on the Toxicology and Carcinogenesis Studies of Furfuryl Alcohol (CASRN 98-00-0) in F344/N Rats and B6C3F1 Mice. NTP TR 482. NIH Publication No. National Toxicology Program, Research Triangle Park, NC.

Irwin, R. (1990). NTP Technical report on the toxicology and carcinogenesis studies of furfural in F344/N rats and B6C3F1 mice (gavage studies).  NIH publication number 90-2837, National Toxicology Program.

NJP (National Toxicology Program). 1993. NTP Technical Report on the Toxicology and Carcinogepesis Studies of Furan (CAS No. 110-00-9) in F344/N rats and B6C3F1 mice (Gavage Studies). NTP-TR-402.

  • Type: Notice
  • July 22, 2015
  • Proposition 65
98-01-1
98-00-0
110-00-9
2015 OEHHA
Petition to Amend

Pursuant to California Government Code section 11340.6, petitioners Mateel Environmental Justice Foundation, Californians for Alternatives to Toxics, Ecological Rights Foundation and Center for Environmental Health petition the California Office of Environmental Health Hazard Assessment to amend CCR, title 27, section 27001(b) to add glyphosate, malathion, tetrachlorvinphos and parathion to the chemicals listed under that section as known to the State to cause cancer.

NTP Information Cited
National Toxicology Program.  Bioassay of parathion for possible carcinogenticity.  National Cancer Institute Carcinogenesis Technical Report Series 1979; 70: 1-123

  • Type: Notice
  • July 17, 2015
  • Proposition 65
56-38-2
2015 OEHHA
Notice of Intent to List: 1-Bromopropane

The California Environmental Protection Agency’s Office of Environmental Health Hazard Assessment (OEHHA) intends to list 1-bromopropane as known to the state to cause cancer under the Safe Drinking Water and Toxic Enforcement Act of 1986.

NTP Information Cited
National Toxicology Program (NTP, 2011). National Toxicology Program. Toxicology and Carcinogenesis Studies of 1‑Bromopropane (CAS No. 106-94-5) in F344/N Rats and B6C3F1 Mice (Inhalation Studies). Technical Report Series No. 564. NIH Publication No. 11-5906. U.S. Department of Health and Human Services, NTP, Research Triangle Park, NC. 

  • Type: Notice
  • July 10, 2015
  • Proposition 65
109-94-5
2015 OEHHA
Chemical Listed Effective June 19, 2015 as Known to the State of California to Cause Reproductive Toxicity: Ethylene Glycol (Ingested)

Effective June 19, 2015, the Office of Environmental Health Hazard Assessment (OEHHA) is adding ethylene glycol (ingested) (CAS No. 107-21-1) to the list of chemicals known to the state to cause reproductive toxicity for purposes of Proposition 65.

NTP Information Cited
NTP-CERHR (2004). NTP-CERHR Monograph on the Potential Human Reproductive and Developmental Effects of Ethylene Glycol. Research Triangle Park, NC, National Toxicology Program, Center for the Evaluation of Risks to Human Reproduction: NIH Publication No. 04 – 4481. 

  • Type: Notice
  • June 19, 2015
  • Proposition 65
107-21-1
2015 NRDC
NRDC, Others Petition FDA to Ban Eight Carcinogenic Flavorings in Food

Eight synthetic flavorings—which may be found in ice cream, baked goods, candy and beverages—are known to cause cancer in lab animals, and should be banned by the U.S. Food and Drug Administration, a coalition of leading health groups said in a petition filed with the agency today.

NTP Information Cited
NTP, Technical Report on the Toxicology and Carcinogenesis Studies of Benzophenone (CAS No 119-61-9) in F33/N Rats and B6C3F1 Mice, 2006. See http://ntp.niehs.nih.gov/results/pubs/longterm/reports/longterm/tr500580/listedreports/tr533/index.html

NTP, Final Report on Carcinogens Background Document for Methyleugenol, 2000. See http://ntp.niehs.nih.gov/pubhealth/roc/listings/m/methyleugenol/summary/index.html

NTP, Carcinogenesis Studies of Methyl Eugenol (CAS No. 93-15-2) in F344/N Rats and B6C3F1 Mice (Gavage Studies), 2000. http://ntp.niehs.nih.gov/results/pubs/longterm/reports/longterm/tr400499/abstracts/tr491/index.html

NTP, Toxicology and Carcinogenesis Studies of β-Myrcene (CAS No. 123-35-3) in F344/N Rats and B6C3F1 Mice (Gavage Studies), 2010. http://ntp.niehs.nih.gov/results/pubs/longterm/reports/longterm/tr500580/listedreports/tr557/index.html

NTP, Toxicology and Carcinogenesis Studies of Pulegone (CAS No. 89-82-7) in F344/N Rats and B6C3F1 Mice (Gavage Studies), 2011. http://ntp.niehs.nih.gov/results/pubs/longterm/reports/longterm/tr500580/listedreports/tr563/index.html

NTP, Toxicology and Carcinogenesis Studies of Pyridine (CAS No. 110-86-1) in F344/N Rats, Wistar Rats, and B6C3F1 Mice (Drinking Water Studies), 2000. http://ntp.niehs.nih.gov/results/pubs/longterm/reports/longterm/tr400499/abstracts/tr470/index.html

NTP, Report on Carcinogens, Thirteenth Edition, Styrene, 2014. See http://ntp.niehs.nih.gov/go/roc13

NTP, Final Report on Carcinogens Background Document for Styrene, 2008. See http://ntp.niehs.nih.gov/pubhealth/roc/listings/s/styrene/summary/index.html

NTP, Technical Report on the Toxicology and Carcinogenesis Studies of 2,4-Hexadienal (89% trans,trans isomer, CAS No. 142-83-6; 11% cis,trans isomer) in F344/N Rats and B6C3F1 Mice (Gavage Studies), 2003. See http://ntp.niehs.nih.gov/ntp/htdocs/lt_rpts/tr509.pdf

  • Type: Notice
  • June 10, 2015
  • NRDC
119-61-9
140-88-5
93-15-2
123-35-3
89-82-7 110-86-1
100-42-5
142-83-6
2015 OEHHA
Proposed Reference Exposure Levels for Carbonyl Sulfide – SRP Review Drafts

The Office of Environmental Health Hazard Assessment (OEHHA) is releasing a draft document for review by the State's Science Review Panel on Toxic Air Contaminants (SRP). The SRP review draft document summarizes the toxicity and derivation of Reference Exposure Levels (RELs) for Carbonyl Sulfide. This document is for review and comment by the Science Review Panel at their meeting on June 19, 2015. RELs are airborne concentrations of a chemical that are not anticipated to result in adverse non–cancer health effects for specified exposure durations in the general population, including sensitive subpopulations.

NTP Information Cited
The National Toxicology Program (NTP) studied 4 strains of mutant Salmonella (TA97,
TA98, TA100, and TA1535) in the Ames test and used from 0.58 to 2.89 µg COS per
test plate with and without induced liver extract from rats or hamsters. They reported a
weakly positive response based on positive results in one strain (TA97) (NTP, 1995).

NTP. (1995). Genetic Toxicology - Bacterial Mutagenicity. NTP Study ID: A35125.
CEBS Accession Number: 002-01834-0001-0000-9

  • Type: Notice
  • May 21, 2015
  • Proposition 65
463-58-1
2015 FDA
Safety and Effectiveness of Health Care Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Proposed Amendment of the Tentative Final Monograph; Reopening of Administrative Record

The Food and Drug Administration (FDA) is issuing this proposed rule to amend the 1994 tentative final monograph or proposed rule (the 1994 TFM) for over-the-counter (OTC) antiseptic drug products. In this proposed rule, we are proposing to establish conditions under which OTC antiseptic products intended for use by health care professionals in a hospital setting or other health care situations outside the hospital are generally recognized as safe and effective. In the 1994 TFM, certain antiseptic active ingredients were proposed as being generally recognized as safe for use in health care settings based on safety data evaluated by FDA as part of its ongoing review of OTC antiseptic drug products. However, in light of more recent scientific developments, we are now proposing that additional safety data are necessary to support the safety of antiseptic active ingredients for these uses. We also are proposing that all health care antiseptic active ingredients have in vitro data characterizing the ingredient’s antimicrobial properties and in vivo clinical simulation studies showing that specified log reductions in the amount of certain bacteria are achieved using the ingredient.

NTP Information Cited
Dermal carcinogenicity data have been obtained from studies where alcohol was used as a vehicle control in 2-year studies. For example, a study performed by the National Toxicology Program (NTP) evaluated the carcinogenic potential of diethanolamine by the dermal route of administration in rats and mice (Ref.
130).

Another study performed by the NTP evaluated the carcinogenic potential of benzethonium chloride by the dermal route of administration in rats and mice (Ref. 131). Each species had a vehicle control group that was treated with 95 percent alcohol only. The rats and mice were treated for 5 days per week for 103 weeks. There was no evidence of an increased incidence of skin tumors in the alcohol-treated rats or mice.

National Toxicology Program, ‘‘TR 478: Toxicology and Carcinogenesis Studies of Diethanolamine in F344/N Rats and B6C3F1 Mice,’’ 1999.

National Toxicology Program, ‘‘NTP Toxicology and Carcinogenesis Studies of Benzethonium Chloride (CAS No. 121–54–0) in F344/N Rats and B6C3F1 Mice (Dermal Studies),’’ National Toxicology Program Technical Report Series, 438:1–220, 1995.

National Toxicology Program, ‘‘TR 510: Toxicology and Carcinogenesis Studies of Urethane, Ethanol, and Urethane/Ethanol in B6C3F1 Mice,’’ 2004.

National Toxicology Program, ‘‘NTP: Toxicology and Carcinogenesis Studies of 4-Hexylresorcinol in F3441N Rats and B6C3F1 Mice, Technical Report Series, No. 330,’’ 1988.

  • Type: Proposed Rule
  • May 01, 2015
  • 80 FR 25166
121-54-0
51-79-6
64-17-5
136-77-6
2015 OEHHA
Hazard Identification Materials for Consideration of the Female Reproductive Toxicity of Bisphenol A

Bisphenol A (BPA) will be considered for listing at the next meeting of the Developmental and Reproductive Toxicant Identification Committee (DARTIC) scheduled for May 7, 2015 in Sacramento. At this meeting,, the DARTIC will consider whether BPA "has been clearly shown through scientifically valid testing according to generally accepted principles to cause female reproductive toxicity".

NTP Information Cited
NTP-CERHR Monograph on the Potential Human Reproductive and Developmental Effects of Bisphenol A (2008) [Attachment to OEHHA, 2009]

 

National Toxicology Program - Center for the Evaluation of Risks to Human Reproduction (NTP-CERHR, 2008). "NTP-CERHR Monograph on the Potential Human Reproductive and Developmental Effects of Bisphenol A." NTP, US Department of Health and Human Services, Research Triangle Park, NC, NIH Publication No. 08-5994.

  • Type: Notice
  • April 23, 2015
  • Proposition 65
80-05-7
2015 OEHHA
Meeting Synopsis and Slide Presentation for the Carcinogen Identification Committee Meeting Held on November 19,2014

The Office of Environmental Health Hazard Assessment (OEHHA) convened a meeting of the Proposition 65 Carcinogen Identification Committee (CIC) on November 19, 2014, at the California Environmental Protection Agency Headquarters Building in Sacramento, California. The Committee considered whether or not dibenzanthracenes (as a chemical group), dibenz[a,c]anthracene, dibenz[a,j]anthracene, and N-nitrosomethyl-n-alkylamines with alkyl chain lengths of 3 through 12 and 14 carbons should be listed under Proposition 65 as known to the state to cause cancer.

NTP Information Cited
DB [a,h]A: NTP (1981): “Reasonably anticipated to be a human carcinogen”

  • Type: Notice
  • April 20, 2015
  • Proposition 65
53-70-3
2015 EPA
Addition of 1-Bromopropane; Community Right-To-Know Toxic Chemical Release Reporting

The Environmental Protection Agency (EPA) is proposing to add 1-bromopropane to the list of toxic chemicals subject to reporting under section 313 of the Emergency Planning and Community Right-to-Know Act (EPCRA) of 1986 and section 6607 of the Pollution Prevention Act (PPA) of 1990. 1-Bromopropance has been classified by the National Toxicology Program in their 13th Report on Carcinogens as “reasonably anticipated to be human carcinogen.” EPA believes that 1-bromopropane meets the EPCRA section 313(d)(2)(B) criteria because it can reasonably be anticipated to cause cancer in humans. Based on a review of the available production and use information, 1-bromopropane is expected to be manufactured, processed, or otherwise used in quantities that would exceed the EPCRA section 313 reporting thresholds.

NTP Information Cited
NTP, 2014. National Toxicology Program. Report on Carcinogens, Thirteenth Edition. Released October 2, 2014. U.S. Department of Health and Human Services, Public Health Service, National Toxicology Program, Research Triangle Park, NC 27709.

 

NTP, 2014. National Toxicology Program. Report on Carcinogens, Thirteenth Edition, Introduction section. Released October 2, 2014. U.S. Department of Health and Human Services, Public Health Service, National Toxicology Program, Research Triangle Park, NC 27709.

 

NTP, 2014. National Toxicology Program. Report on Carcinogens, Thirteenth Edition, Process for Preparation of the Report on Carcinogens section. Released October 2, 2014. U.S. Department of Health and Human Services, Public Health Service, National Toxicology Program, Research Triangle Park, NC 27709.

 

NTP, 2013. Report on Carcinogens Monograph on 1-Bromopropane. Office of the Report on Carcinogens, Division of the National Toxicology Program, National Institute of Environmental Health Sciences, U.S. Department of Health and Human Services. NIH Publication No. 13–5982, September 25, 2013

 

NTP, 2014. National Toxicology Program. Report on Carcinogens, Thirteenth Edition, Profile for 1-Bromopropane. Released October 2, 2014. U.S. Department of Health and Human Services, Public Health Service, National Toxicology Program

  • Type: Proposed Rule
  • April 15, 2015
  • 80 FR 20189
109-94-5
2015 OEHHA
Chemical Listed Effective March 27, 2015 as Known to the State of California to Cause Cancer: Beta-Myrcene

Effective March 27, 2015,the Office of Environmental Health Hazard Assessment (OEHHA) is adding beta-myrcene(CAS No. 123-35-3)to the list of chemicals known to the state to cause cancer for purposes of Proposition 65

NTP Information Cited
In 2010, the NTP published a report on beta-myrcene (β‑myrcene), entitled Toxicology and Carcinogenesis Studies of β-Myrcene (CAS No. 123-35-3) in F344/N Rats and B6C3F1 Mice (Gavage Studies), that concludes that the chemical causes cancer (NTP, 2010).  This report satisfies the formal identification and sufficiency of evidence criteria in the Proposition 65 regulations.

NTP (2010). Toxicology and Carcinogenesis Studies of β-Myrcene (CAS No. 123-35-3) in F344/N Rats and B6C3F1 Mice (Gavage Studies). Technical Report Series No. 557, NIH Publication No. 10-5898. U.S. Department of Health and Human Services, NTP, Research Triangle Park, NC.

  • Type: Notice
  • March 24, 2015
  • Proposition 65
123-35-3
2015 OEHHA
Notice of Intent to List: Styrene

The California Environmental Protection Agency’s Office of Environmental Health Hazard Assessment (OEHHA) intends to list styrene as known to the State to cause cancer under the Safe Drinking Water and Toxic Enforcement Act of 1986.

NTP Information Cited
In 2011, NTP published the Twelfth Edition of the Report on Carcinogens (NTP, 2011). This report satisfies the formal identification and sufficiency of evidence criteria in the Proposition 65 regulations for styrene. NTP concluded that styrene is “reasonably anticipated to be a human carcinogen based on limited evidence of carcinogenicity from studies in humans, sufficient evidence of carcinogenicity from studies in experimental animals, and supporting data on mechanisms of carcinogenesis” (emphasis in original). OEHHA is relying on NTP’s discussion of data and conclusions in the report that styrene causes cancer.

National Toxicology Program (NTP, 2011). Report on Carcinogens, Twelfth Edition, U.S. Department of Health and Human Services, Public Health Service, NTP, Research Triangle Park, North Carolina, page 383-391.

  • Type: Notice
  • February 27, 2015
  • Proposition 65
100-42-5
2015 EPA
Draft Test Guidelines; Endocrine Disruptor Screening Program Test Guidelines (Series 890); Three Tier 2 Non-Mammalian Tests; Notice of Availability and Request for Comment

EPA is announcing the availability of three draft test guidelines for public review and comment that are being added to its 890 Series, entitled “Endocrine Disruptor Screening Program Test Guidelines.” The draft guidelines relate to the following three non-mammalian species tests identified under Tier 2 of the Endocrine Disruptor Screen Program (EDSP): Japanese quail 2-generation reproduction test; Medaka extended 1-generation reproduction test; and Larval amphibian growth and development assay. These draft test guidelines are part of a series of test guidelines established by the Office of Chemical Safety and Pollution Prevention (OCSPP) for use in testing pesticides and chemical substances. The test guidelines serve as a compendium of accepted scientific methodologies and protocols that are intended to provide data to inform regulatory decisions. The test guidelines provide guidance for conducing the test, and are also used by EPA, the public, and companies that submit data to EPA.

NTP Information Cited
EPA followed the general validation principles of the Organization for Economic Co-Operation and Development (OECD) and the Intergovernmental Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM) in the development of the four non-mammalian Tier 2 tests.

  • Type: Notice of availability, and request for comments
  • January 30, 2015
  • 80 FR 5107
2015 EPA
Toluene Diisocyanates (TDI) and Related Compounds; Significant New Use Rule

Under the Toxic Substance Control Act (TSCA), EPA is proposing significant new use rule (SNUR) for 2,4- toluene diisocyanate, 2,6-toluene diisocyanate, toluene diisocyanate unspecified isomers (these three chemical substances are hereafter referred to as toluene diisocyanates or TDI) and related compounds as identified in this proposed rule. The proposed significant new use is any use in a consumer product, with a proposed exception for use of certain chemical substances in coatings, elastomers, adhesives, binders, and sealants that results in less than or equal to 0.1 percent by weight of TDI in a consumer product. In addition, EPA is also proposing that the general SNUR article exemption for persons who import or process these chemical substances as part of an article would not apply." "Persons subject to the SNUR would be required to notify EPA at least 90 days before commencing any manufacturing or processing. The required notification would provide EPA with the opportunity to evaluate the intended use and, if necessary based on the information available at that time, an opportunity to protect against potential unreasonable risks, if any, from that activity before it occurs."

NTP Information Cited
TDI has also been classified by the European Commission (EC) as Category 3 for carcinogenicity (‘‘causes concerns for humans owing to possible carcinogenic effects’’) (Ref. 16) and by the United States National Toxicology Program (NTP) as ‘‘reasonably anticipated to be a human carcinogen’’ (Ref. 17).

  • Type: Proposed Rule
  • January 15, 2015
  • 80 FR 2068
9019-85-6
9017-01-0
26747-90-0
26603-40-7
26603-40-7 91-08-7
584-84-9
26471-62-5
2015 OEHHA
Notice of Proposed Rulemaking and Announcement of Public Hearing Title 27, California Code of Regulations Proposed Adoption of Section 25205 Proposition 65 Lead Agency Website

This regulation would establish the framework for a website operated by OEHHA that would provide supplemental information to the public about potential exposures to Proposition 65 listed chemicals.

NTP Information Cited
REFERENCES FOR SECTION 25602
US Department of Health and Human Services, National Toxicology Program. 13th Report on Carcinogens (October 2014).

  • Type: Notice
  • January 12, 2015
  • Proposition 65
N/A