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Regulatory Actions for Year 2004


California Office of Environmental Health Hazard Assessment (OEHHA)

Notice Type Title Summary of Notice NTP Information Cited CASRN
Notice Chemical Listed Effective December 7, 2004 as known to the State of California to Cause Reproductive Toxicity: 1-Bromopropane (1-BP) The Office of Environmental Health Hazard Assessment (OEHHA) of the California Environmental Protection Agency is adding 1-bromopropane (1-BP) to the list of chemicals known to the state to cause reproductive toxicity for purposes of the Safe Drinking Water and Toxic Enforcement Act of 1986 (Health and Safety Code section 25249.5 et seq., Proposition 65). The listing of the chemical is effective December 7, 2004. Toxicological Endpoint: Developmental, female reproductive and male reproductive toxicity

December 07, 2004 -- Proposition 65
NTP Center for the Evaluation of Risks to Human Reproduction (NTP-CERHR 2003). NTP-CERHR Monograph on the Potential Human Reproductive and Developmental Effects of 1-Bromopropane (CAS No. 106-94-5). NIH Publication No. 04-4479 106-94-5
Notice Chemical Listed Effective December 3, 2004 as known to the State of California to Cause Cancer: Riddelliine The Office of Environmental Health Hazard Assessment (OEHHA) of the California Environmental Protection Agency is adding riddelliine to the list of chemicals known to the state to cause cancer for purposes of the Safe Drinking Water and Toxic Enforcement Act of 1986 (Health and Safety Code section 25249.5, Proposition 65). The listing of riddelliine is effective December 3, 2004. Toxicological Endpoint: Cancer

December 03, 2004 -- Proposition 65
Health and Safety Code section 25249.8(a) requires that certain substances identified by the International Agency for Research on Cancer (IARC) or the National Toxicology Program (NTP), as described in Labor Code sections 6382(b)(1) and (d), be included on the Proposition 65 list. 
Riddelline is a current candidate substance under review for the NTP Twelfth Edition Report on Carcinogens. 
National Toxicology Program (NTP, 2003). Toxicology and Carcinogensis Studies of Riddelliine (CAS No. 23246-96-0) in F344/N Rats and B6C3F1 Mice (Gavage Studies). NTP Technical Report Series No. 508. NIH Publication No. 03-4442.
23246-96-0
Notice Chemicals Listed Effective July 9, 2004 as Known to the State of California to Cause Cancer: aristolochic acids and herbal remedies containing plant species of the genus Aristolochia The Office of Environmental Health Hazard Assessment (OEHHA) of the California Environmental Protection Agency is adding aristolochic acids and herbal remedies containing plant species of the genus Aristolochia to the list of chemicals known to the state to cause cancer for purposes of the Safe Drinking Water and Toxic Enforcement Act of 1986 (Health and Safety Code section 25249.5, Proposition 65). The listing of "aristolochic acids and herbal remedies containing plant species of the genus Aristolochia is effective July 9, 2004. Toxicological Endpoint: Cancer

July 09, 2004 -- Proposition 65
Health and Safety Code section 25249.8(a) requires that certain substances identified by the International Agency for Research on Cancer (IARC) or the National Toxicology Program (NTP), as described in Labor Code sections 6382(b)(1) and (d), be included on the Proposition 65 list. 
Aristolochic acid related exposures are current candidate substances under review for the NTP Twelfth Edition, Report on Carcinogens.
Aristolochia
Notice Chemicals Listed Effective June 11, 2004 as Known to the State of California to Cause Cancer: propylene glycol mono-t-butyl ether The Office of Environmental Health Hazard Assessment (OEHHA) of the California Environmental Protection Agency is adding 3,3'-dimethoxybenzidine-(DMOB)based dyes metabolized to 3,3'-dimethoxybenzidine, 3,3'-dimethylbenzidine- (DMB)based dyes metabolized to 3,3'-dimethylbenzidine, ethylbenzene, propylene glycol mono-t-butyl ether, and thiouracil to the list of chemicals known to the state to cause cancer for purposes of the Safe Drinking Water and Toxic Enforcement Act of 1986 (Health and Safety Code section 25249.5 et seq., Proposition 65). The listing of these chemicals is effective June 11, 2004. Toxicological Endpoint: Cancer

June 11, 2004 -- Proposition 65
National Toxicology Program (NTP, 2004). Toxicology and Carcinogenesis Studies of Propylene Glycol Mono-t-Butyl Ether (CAS No. 57018-52-7) In F344/N Rats and B6C3F1 Mice and a Toxicology Study of Propylene Glycol Mono-t-Butyl Ether In Male NBR Rats (Inhalation Studies). NTP Technical Report Series No. 515. NIH Publication No. 04-4449 57018-52-7
Notice Chemicals Listed Effective June 11, 2004 as Known to the State of California to Cause Cancer: 3,3'-dimethylbenzidine (DMB)-based dyes metabolized to 3,3'-dimethylbenzidine The Office of Environmental Health Hazard Assessment (OEHHA) of the California Environmental Protection Agency is adding 3,3'-dimethoxybenzidine-(DMOB)based dyes metabolized to 3,3'-dimethoxybenzidine, 3,3'-dimethylbenzidine- (DMB)based dyes metabolized to 3,3'-dimethylbenzidine, ethylbenzene, propylene glycol mono-t-butyl ether, and thiouracil to the list of chemicals known to the state to cause cancer for purposes of the Safe Drinking Water and Toxic Enforcement Act of 1986 (Health and Safety Code section 25249.5 et seq., Proposition 65). The listing of these chemicals is effective June 11, 2004. Toxicological Endpoint: Cancer

June 11, 2004 -- Proposition 65
National Toxicology Program (NTP, 2002). Tenth Report on Carcinogens. Carcinogen Profiles. U.S. Department of Health and Human Services, Public Health Service. National Institute of Environmental Health Sciences, Research Triangle Park, NC. DMB based dyes
Notice Chemicals Listed Effective June 11, 2004 as Known to the State of California to Cause Cancer: 3,3'-dimethoxybenzidine-based dyes metabolized to 3,3'-dimethoxybenzidine The Office of Environmental Health Hazard Assessment (OEHHA) of the California Environmental Protection Agency is adding 3,3'-dimethoxybenzidine-based dyes metabolized to 3,3'-dimethoxybenzidine, 3,3'-dimethylbenzidine-based dyes metabolized to 3,3'-dimethylbenzidine, ethylbenzene, propylene glycol mono-t-butyl ether, and thiouracil to the list of chemicals known to the state to cause cancer for purposes of the Safe Drinking Water and Toxic Enforcement Act of 1986 (Health and Safety Code section 25249.5 et seq., Proposition 65). The listing of these chemicals is effective June 11, 2004. Toxicological Endpoint: Cancer

June 11, 2004 -- Proposition 65
National Toxicology Program (NTP, 2002). Tenth Report on Carcinogens. Carcinogen Profiles. U.S. Department of Health and Human Services, Public Health Service. National Institute of Environmental Health Sciences, Research Triangle Park, NC. DMOB based dyes
Notice Chemical Listed Effective May 7, 2004 as known to the State of California to Cause Cancer: Nickel Compounds The Office of Environmental Health Hazard Assessment (OEHHA) of the California Environmental Protection Agency is adding nickel compounds to the list of chemicals known to the state to cause cancer for purposes of the Safe Drinking Water and Toxic Enforcement Act of 1986 (Health and Safety Code section 25249.5, Proposition 65). The listing of nickel compounds is effective May 7, 2004. Toxicological Endpoint: Cancer

May 07, 2004 -- Proposition 65
NTP released its Tenth Report on Carcinogens in 2002 in which it included nickel compounds on the list of substances as known to be human carcinogens. 
National Toxicology Program (NTP, 2002). Report on Carcinogens, Tenth Edition. Carcinogen Profiles. U.S. Department of Health and Human Services, Public Health Service. National Institute of Environmental Health Sciences, Research Triangle Park, NC.
Nickel compounds
Notice Announcement of Publication of the Final Public Health Goal for Arsenic in Drinking Water The Office of Environmental Health Hazard Assessment (OEHHA) of the California Environmental Protection Agency announces the publication of the final Public Health Goal (PHG) for arsenic.

April 23, 2004 -- Public Health Goals
NTP (1989). Toxicology and Carcinogenesis Studies of Roxarsone (CAS No. 121-19-7) in F344/N Rats and B6C3F1 Mice (Feed Studies). TR-345. 121-19-7

Department of Treasury (Treasury)

Notice Type Title Summary of Notice NTP Information Cited CASRN
Final Rule Removal of Requirement to Disclose Saccharin in the Labeling of Wine, Distilled Spirits, and Malt Beverages The Department of the Treasury is removing the requirement for bottlers of wine, distilled spirits, and malt beverages to show a warning on products containing saccharin.

June 16, 2004 -- 69 FR 33573
Since 1981, saccharin had been listed in the Report on Carcinogens as reasonably anticipated to be a human carcinogen. However, it was delisted in the 9th Report on Carcinogens. The NTP determined that the rodent cancer data is insufficient to meet the current criteria to list the chemical as reasonably anticipated to be a human carcinogen. This is based on the perception that the observed bladder tumors in rats arise by mechanisms not relevant to humans and the lack of data in humans suggesting a carcinogenic hazard. 81-07-2
Final Rule Removal of Requirement To Disclose Saccharin in the Labeling of Wine, Distilled Spirits, and Malt Beverages Amends the Alcohol and Tobacco Tax and Trade Bureau's labeling regulations to remove the requirement for bottlers of wine, distilled spirits, and malt beverages to show a warning on products containing saccharin. The regulatory amendments in this document reflect the National Toxicology Program's revised findings about saccharin and the removal of the statutory requirement for the warning.

June 16, 2004 -- 69 FR 33572
On May 15, 2000, the U.S. Department of Health and Human Services, Public Health Service, National Toxicology Program published the 9th Report on Carcinogens. The report delisted saccharin, which had been listed in the Report as "reasonably anticipated to be a human carcinogen" since 1981. The Report explained that saccharin was removed from the list after a review of the carcinogenicity data for saccharin concluded that rodent cancer data are not sufficient to meet the current criteria to list this chemical as reasonably anticipated to be a human carcinogen based on the perception that the observed bladder tumors in rats arise by mechanisms not relevant to humans, and the lack of data in humans suggesting a carcinogenic hazard. 81-07-2

Environmental Protection Agency (EPA)

Notice Type Title Summary of Notice NTP Information Cited CASRN
Final Rule List of Hazardous Air Pollutants, Petition Process, Lesser Quantity Designations, Source Category List; Petition To Delist of Ethylene Glycol Monobutyl Ether The EPA is amending the list of hazardous air pollutants contained in section 112(b)(1) of the Clean Air Act by removing the compound ethylene glycol monobutyl ether (EGBE) (2-Butoxyethanol)(CAS No. 111-76-2) from the group of glycol ethers.

November 29, 2004 -- 69 FR 69320
In the preamble to the proposed rule, we stated that the Agency believes EGBE is not genotoxic and that two distinctly different nonlinear modes of action are principally responsible for the increased forestomach and liver tumors reported by NTP (TR-494). 111-76-2
Final Rule National Emission Standards for Hazardous Air Pollutants for Industrial, Commercial, and Institutional Boilers and Process Heaters The EPA is promulgating national emission standards for hazardous air pollutants for industrial, commercial, and institutional boilers and process heaters and has identified industrial, commercial, and institutional boilers and process heaters as major sources of hazardous air pollutants.

September 13, 2004 -- 69 FR 55217
A NTP study (TR-392) showed no evidence of carcinogenic activity in male rats or male and female mice, and equivocal evidence in female rats, from ingestion of chlorinated water. The EPA has not classified chlorine for potential carcinogenicity. 7782-50-5
7681-52-9
Proposed National Emission Standards for Hazardous Air Pollutants: Proposed Standards for Hazardous Air Pollutants for Hazardous Waste Combustors The EPA proposes national emission standards for hazardous air pollutants (HAPs) for hazardous waste combustors (HWCs). These proposed standards will, when final, implement section 112(d) of the Clean Air Act by requiring HWCs to meet HAP emission standards reflecting the application of the maximum achievable control technology.

April 20, 2004 -- 69 FR 21198
Nickel has been identified as a HAP emitted from HWCs. The EPA used data from the NTP inhalation studies of Nickel (II) Oxide (TR 451) and Nickel Sulfate Hexahydrate (TR 454) in identifying risks associated with exposure to nickel. The 2001 DHHS National Toxicology Program 9th Report on Carcinogens classified 2,3,7,8-TCDD as a known human carcinogen.
1313-99-1
10101-97-0
1746-01-6
Proposed National Emission Standards for Hazardous Air Pollutants: Proposed Standards for Hazardous Air Pollutants for Hazardous Waste Combustors (Phase I Final Replacement Standards and Phase II) This action proposes national emission standards for hazardous air pollutants for hazardous waste combustors including hazardous waste burning incinerators, cement kilns, lightweight aggregate kilns, industrial/commercial/ institutional boilers and process heaters, and hydrochloric acid production furnaces that EPA has identified as major sources of hazardous air pollutant emissions. Proposed standards will implement section 112(d) of the Clean Air Act (CAA) by requiring hazardous waste combustors to meet emission standards.

April 20, 2004 -- 69 FR 21197
In 2001 the DHHS National Toxicology Program classified 2,3,7,8-TCDD as a know human carcinogen in it's 9th Report on Carcinogens.

A pair of inhalation studies (TR-453 and TR-454) performed under the auspices of the National Toxicology Program (NTP) of the National Institutes of Health concluded that there was no evidence of carcinogenic activity of soluble nickel salts in rats or mice and that there was some evidence of carcinogenic activity of nickel oxide (TR-451) in male and female rats based on increased incidence of alveolar/bronchiolar adenoma or carcinoma and increased incidence of benign or malignant pheochromocytoma (a tumor of the adrenal gland) and equivocal evidence in mice based on marginally increased incidence of alveolar/bronchiolar adenoma or carcinoma in females and no evidence in males.

In December 2006, the Tenth Annual Report on Carcinogens classifies nickel compounds as "known to be human carcinogens".
10101-97-0
12035-72-2
1313-99-1
1746-01-6
Notice Fifty-Third Report of the TSCA Interagency Testing Committee to the Administrator of the Environmental Protection Agency; Receipt of Report and Request for Comments The Toxic Substances Control Act (TSCA) Interagency Testing Committee (ITC) transmitted its Fifty-Third Report to the Administrator of the EPA on December 2, 2003 revising the Priority Testing List by adding 3 pyridinamines and 20 tungsten compounds requesting that EPA add the 3 pyridinamines and 20 tungsten compounds to the TSCA section 8(a) Preliminary Assessment Information Reporting (PAIR) rule and soliciting voluntary use, exposure, and effects information for 3 pyridinamines, 20 tungsten compounds, and 43 vanadium compounds through its Voluntary Information Submissions Innovative Online Network.

January 15, 2004 -- 69 FR 2468
Tungsten was nominated for toxicology and carcinogenicity studies to the National Toxicology Program by the Centers for Disease Control and Prevention's National Center for Environmental Health based on recent data showing elevated tungsten body burdens in residents of Fallon, NV, and the limited data available to assess the potential long-term adverse health effects of tungsten exposure. Further information is needed to more fully evaluate human and environmental exposures and health effects. 1314-35-8

Food and Drug Administration (FDA)

Notice Type Title Summary of Notice NTP Information Cited CASRN
Notice Furan in Food, Thermal Treatment; Request for Data and Information The FDA is requesting the submission of data and information on furan, a heat treatment related byproduct that has been detected in certain thermally treated foods.

May 10, 2004 -- 69 FR 25911
Results from the NTP bioassay on furan (TR-402) showed clear evidence of carcinogenic activity in both rats and mice. Cytotoxic and carcinogenic effects were seen at all doses, and a no adverse effect level was not identified. The FDA would like to acquire data on the effects of furan doses lower than those used in the NTP study. 110-00-9
Final Rule Final Rule Declaring Dietary Supplements Containing Ephedrine Alkaloids Adulterated Because They Present an Unreasonable Risk Final Rule Declaring Dietary Supplements Containing Ephedrine Alkaloids Adulterated Because They Present an Unreasonable Risk

February 11, 2004 -- 69 FR 6787
One comment objected that animal studies using ephedrine alkaloids to evaluate the safety of ephedrine alkaloids as dietary ingredients were not considered in the evaluation and cited the results of the National Toxicology Program's long term rodent studies on ephedrine (TR-307). 134-72-5

Occupational Safety and Health Administration (OSHA)

Notice Type Title Summary of Notice NTP Information Cited CASRN
Proposed Occupational Exposure to Hexavalent Chromium OSHA proposes to amend its existing standard for employee exposure to hexavalent chromium (Cr(VI)). The basis for issuance of this proposal is a preliminary determination by the Assistant Secretary that employees exposed to Cr(VI) face a significant risk to their health at the current permissible exposure limit and that promulgating this proposed standard will substantially reduce that risk.

October 04, 2004 -- 69 FR 59305
The NTP's First Annual Report on Carcinogens identified calcium chromate, chromium
chromate, strontium chromate, and zinc chromate as carcinogens in 1980.

The NTP conducted an extensive multigenerational reproductive assessment by continuous breeding where the chromate was administered in the diet. The assessment yielded negative results.
13765-19-0
7778-50-9