How NTP Studies are Used to Protect Human Health
Federal and State Regulatory Agencies use the NTP study data in considering the need for regulation of specific chemicals to protect human health.
| Notice Type | Title | Summary of Notice | NTP Information Cited | CAS Number |
|---|---|---|---|---|
| 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 | Identification of Priority Data Needs for Two Priority Hazardous Substances | Request for public comments on the identification of priority data needs for two priority hazardous substances, and an ongoing call for voluntary research proposals. September 8, 2006 -- 71 FR 53102 |
A Tri-Agency Superfund Applied Research Committee (TASARC) comprised of scientists from ATSDR, the National Toxicology Program (NTP), and EPA, will review all proposals. | N/A |
| Notice | Availability of Draft Toxicological Profiles | The Comprehensive Environmental Response, Compensation, and Liability Act of 1980 (CERCLA), as amended by the Superfund Amendments and Reauthorization Act of 1986 (SARA), Section 104(i)(3) [42 U.S.C. 9604(i)(3)] directs the Administrator of ATSDR to prepare toxicological profiles of priority hazardous substances and to revise and publish each updated toxicological profile as necessary. This notice announces the availability of the 20th set of toxicological profiles, which consists of one new draft and six updated drafts, prepared by ATSDR for review and comment. October 18, 2006 -- 71 FR 61479 |
The profiles must also include a determination of whether adequate information on the health effects of each substance is available or in the process of development. When adequate information is not available, ATSDR, in cooperation with the National Toxicology Program (NTP), is required to assure the initiation of research to determine these health effects. | N/A |
| Notice | Intent To Develop Two Interaction Profiles | This notice announces the intent of ATSDR to develop two interaction profiles. July 3, 2007 -- 72 FR 36456 |
Where such information is not available or under development, ATSDR shall, in cooperation with the National Toxicology Program, initiate a program of research to determine these health effects. | N/A |
| Total Notices | 4 | |||
| Notice Type | Title | Summary of Notice | NTP Information Cited | CAS Number |
|---|---|---|---|---|
| Notice | Chemicals Listed Effective May 1, 1997 as Known to the State to Cause Cancer or Reproductive Toxicity: 9 chemicals | The Office of Environmental Health Hazard Assessment (OEHHA) of the California Environmental Protection Agency has added nine chemicals to the list of chemicals known to the State to cause cancer or reproductive toxicity, for purposes of the Safe Drinking Water and Toxic Enforcement Act of 1986 (Proposition 65). These chemicals are listed effective May 1, 1997. Toxicological Endpoint: Cancer May 1, 1997 -- Proposition 65 |
National Toxicology Program (NTP, 1995a). Toxicology and Carcinogenesis Studies of Nitromethane (CAS No. 72-52-5) in F344/N Rats and B6C3F1 Mice (Inhalation Studies). Board Draft. NTP Technical Report Series No. 461. NTIS Publication No. 95-3377. | 75-52-5 |
| Notice | Chemicals Listed Effective May 1, 1997 as Known to the State to Cause Cancer or Reproductive Toxicity: 9 chemicals | The Office of Environmental Health Hazard Assessment (OEHHA) of the California Environmental Protection Agency has added nine chemicals to the list of chemicals known to the State to cause cancer or reproductive toxicity, for purposes of the Safe Drinking Water and Toxic Enforcement Act of 1986 (Proposition 65). These chemicals are listed effective May 1, 1997. Toxicological Endpoint: Cancer May 1, 1997 -- Proposition 65 |
National Toxicology Program (NTP, 1995b). Toxicology and Carcinogenesis Studies of Tetrafluoroethylene (CAS No. 116-14-3) in F344/N Rats and B6C3F1 Mice (Inhalation Studies). Board Draft. NTP Technical Report Series No. 450. NTIS Publication No. 95-3366. | 75-02-5 |
| Notice | Chemicals Listed Effective August 26, 1997 as Known to the State to Cause Cancer or Reproductive Toxicity: 16 Chemicals | The Office of Environmental Health Hazard Assessment (OEHHA) of the California Environmental Protection Agency has added 18 chemicals to the list of chemicals known to the State to cause cancer or reproductive toxicity, for purposes of the Safe Drinking Water and Toxic Enforcement Act of 1986 (Proposition 65 or the Act). These chemicals are listed effective August 26, 1997. Toxicological Endpoint: Cancer August 15, 1997 -- Proposition 65 |
National Toxicology Program (NTP, 1994a). Toxicology and Carcinogenesis Studies of 1-amino-2,4-dibromoanthraquinone (CAS No. 81-49-2) in F344/N Rats and B6C3F1 Mice (Feed Studies). Board Draft. NTP Technical Report Series No. 383. NTIS Publication No. 94-2838. | 81-49-2 |
| Notice | Chemicals Listed Effective August 26, 1997 as Known to the State to Cause Cancer or Reproductive Toxicity: 16 Chemicals | The Office of Environmental Health Hazard Assessment (OEHHA) of the California Environmental Protection Agency has added 18 chemicals to the list of chemicals known to the State to cause cancer or reproductive toxicity, for purposes of the Safe Drinking Water and Toxic Enforcement Act of 1986 (Proposition 65 or the Act). These chemicals are listed effective August 26, 1997. Toxicological Endpoint: Cancer August 15, 1997 -- Proposition 65 |
National Toxicology Program (NTP, 1994b). Toxicology and Carcinogenesis Studies of C.I. Direct Blue 218 (CAS No. 28407-37-6) in F344/N Rats and B6C3F1 Mice (Feed Studies). NTP Technical Report Series No. 430. NTIS Publication No. 94-3161. | 28407-37-6 |
| Notice | Chemicals Listed Effective August 26, 1997 as Known to the State to Cause Cancer or Reproductive Toxicity: 16 Chemicals | The Office of Environmental Health Hazard Assessment (OEHHA) of the California Environmental Protection Agency has added 18 chemicals to the list of chemicals known to the State to cause cancer or reproductive toxicity, for purposes of the Safe Drinking Water and Toxic Enforcement Act of 1986 (Proposition 65 or the Act). These chemicals are listed effective August 26, 1997. Toxicological Endpoint: Cancer August 15, 1997 -- Proposition 65 |
National Toxicology Program (NTP, 1992). Toxicology and Carcinogenesis Studies of C.I. Direct Blue 15 (CAS No. 2429-74-5) in F344/N Rats and B6C3F1 Mice (DrinkingWater Studies). NTP Technical Report Series No. 397. NTIS Publication No. 92-2852. | 2429-74-5 |
| Notice | Notice to Interested Parties Chemicals Listed Effective May 15, 1998 as Known to the State to Cause Cancer or Reproductive Toxicity: 28 Chemicals | The Office of Environmental Health Hazard Assessment (OEHHA) of the California
Environmental Protection Agency has added 28 chemicals to the list of chemicals known to the
State to cause cancer or reproductive toxicity, for purposes of the Safe Drinking Water and Toxic
Enforcement Act of 1986 (Proposition 65 or the Act). These chemicals are listed effective
May 15, 1998. Toxicological Endpoint: Cancer
May 15, 1998 -- Proposition 65 |
National Toxicology Program (NTP, 1982a). Carcinogenesis Bioassay of C.I. Solvent Yellow 14 (CAS No. 842-07-9) in F344/N Rats and B6C3F1 Mice (Feed Study). NTP Technical Report Series No. 226. NTIS Publication No. 82-1782. | 842-07-9 |
| Notice | Notice to Interested Parties Chemicals Listed Effective May 15, 1998 as Known to the State to Cause Cancer or Reproductive Toxicity: 28 Chemicals | The Office of Environmental Health Hazard Assessment (OEHHA) of the California Environmental Protection Agency has added 28 chemicals to the list of chemicals known to the State to cause cancer or reproductive toxicity, for purposes of the Safe Drinking Water and Toxic Enforcement Act of 1986 (Proposition 65 or the Act). These chemicals are listed effective May 15, 1998. Toxicological Endpoint: Cancer May 15, 1998 -- Proposition 65 |
National Toxicology Program (NTP, 1997). Toxicology and Carcinogenesis Studies of Salicylazosulfapyridine (CAS No. 599-79-1) in F344/N Rats and B6C3F1 Mice (Gavage Studies). NTP Technical Report Series No. 457. NTIS Publication No. 97-3373. | 599-79-1 |
| Notice | Notice to Interested Parties Chemicals Listed Effective May 15, 1998 as Known to the State to Cause Cancer or Reproductive Toxicity: 28 Chemicals | The Office of Environmental Health Hazard Assessment (OEHHA) of the California Environmental Protection Agency has added 28 chemicals to the list of chemicals known to the State to cause cancer or reproductive toxicity, for purposes of the Safe Drinking Water and Toxic Enforcement Act of 1986 (Proposition 65 or the Act). These chemicals are listed effective May 15, 1998. Toxicological Endpoint: Cancer May 15, 1998 -- Proposition 65 |
National Toxicology Program (NTP, 1994). Seventh Annual Report on Carcinogens: 1994. Volume 1: 357-362. US Department of Health and Human Services, NTP, Research Triangle Park, NC. | 612-83-9 |
| Notice | Notice to Interested Parties Chemicals Listed Effective May 15, 1998 as Known to the State to Cause Cancer or Reproductive Toxicity: 28 Chemicals | The Office of Environmental Health Hazard Assessment (OEHHA) of the California Environmental Protection Agency has added 28 chemicals to the list of chemicals known to the State to cause cancer or reproductive toxicity, for purposes of the Safe Drinking Water and Toxic Enforcement Act of 1986 (Proposition 65 or the Act). These chemicals are listed effective May 15, 1998. Toxicological Endpoint: Cancer May 15, 1998 -- Proposition 65 |
National Toxicology Program (NTP, 1987). Toxicology and Carcinogenesis Studies of Methyl Carbamate (CAS No. 598-55-0) in F344/N Rats and B6C3F1 Mice (Gavage Studies). NTP Technical Report Series No. 328. NTIS Publication No. 88-2584. | 598-55-0 |
| Notice | Notice to Interested Parties Chemicals Listed Effective May 15, 1998 as Known to the State to Cause Cancer or Reproductive Toxicity: 28 Chemicals | The Office of Environmental Health Hazard Assessment (OEHHA) of the California Environmental Protection Agency has added 28 chemicals to the list of chemicals known to the State to cause cancer or reproductive toxicity, for purposes of the Safe Drinking Water and Toxic Enforcement Act of 1986 (Proposition 65 or the Act). These chemicals are listed effective May 15, 1998. Toxicological Endpoint: Cancer May 15, 1998 -- Proposition 65 |
National Toxicology Program (NTP, 1981). Carcinogenesis Bioassay of Cytembena (CAS No. 21739-91-3). NTP Technical Report Series No. 207. NTIS Publication No. 81-1763. | 21739-91-3 |
| Notice | Notice to Interested Parties Chemicals Listed Effective May 15, 1998 as Known to the State to Cause Cancer or Reproductive Toxicity: 28 Chemicals | The Office of Environmental Health Hazard Assessment (OEHHA) of the California Environmental Protection Agency has added 28 chemicals to the list of chemicals known to the State to cause cancer or reproductive toxicity, for purposes of the Safe Drinking Water and Toxic Enforcement Act of 1986 (Proposition 65 or the Act). These chemicals are listed effective May 15, 1998. Toxicological Endpoint: Cancer
May 15, 1998 -- Proposition 65 |
National Toxicology Program (NTP, 1989a). Toxicology and Carcinogenesis Studies of para-Chloroaniline Hydrochloride (CAS No. 20265-96-7) in F344/N Rats and B6C3F1 Mice (Gavage Studies). NTP Technical Report Series No. 351. | 20265-96-7 |
| Notice | Notice to Interested Parties Chemicals Listed Effective May 15, 1998 as Known to the State to Cause Cancer or Reproductive Toxicity: 28 Chemicals | The Office of Environmental Health Hazard Assessment (OEHHA) of the California Environmental Protection Agency has added 28 chemicals to the list of chemicals known to the State to cause cancer or reproductive toxicity, for purposes of the Safe Drinking Water and Toxic Enforcement Act of 1986 (Proposition 65 or the Act). These chemicals are listed effective May 15, 1998. Toxicological Endpoint: Cancer May 15, 1998 -- Proposition 65 |
National Toxicology Program (NTP, 1996b). Toxicology and Carcinogenesis Studies of Phenolphthalein (CAS No. 77-09-8) in F344/N Rats and B6C3F1 Mice (Feed Studies). NTP Technical Report Series No. 465. NTIS Publication No. 97-3390. | 77-09-8 |
| Notice | Notice to Interested Parties Chemicals Listed Effective May 15, 1998 as Known to the State to Cause Cancer or Reproductive Toxicity: 28 Chemicals | The Office of Environmental Health Hazard Assessment (OEHHA) of the California Environmental Protection Agency has added 28 chemicals to the list of chemicals known to the State to cause cancer or reproductive toxicity, for purposes of the Safe Drinking Water and Toxic Enforcement Act of 1986 (Proposition 65 or the Act). These chemicals are listed effective May 15, 1998. Toxicological Endpoint: Cancer May 15, 1998 -- Proposition 65 |
National Toxicology Program (NTP, 1996a). NTP Technical Report on Comparative Toxicity and Carcinogenicity Studies of o-Nitrotoluene and o-Toluidine Hydrochloride (CAS Nos. 88-72-2 and 636-21-5). Administered in Feed to Male F344/N Rats. NTP Toxicity Report Series No. 44. NTIS Publication Number 96-3936. | 88-72-2 |
| Notice | Notice to Interested Parties Chemicals Listed Effective May 15, 1998 as Known to the State to Cause Cancer or Reproductive Toxicity: 28 Chemicals | The Office of Environmental Health Hazard Assessment (OEHHA) of the California Environmental Protection Agency has added 28 chemicals to the list of chemicals known to the State to cause cancer or reproductive toxicity, for purposes of the Safe Drinking Water and Toxic Enforcement Act of 1986 (Proposition 65 or the Act). These chemicals are listed effective May 15, 1998. Toxicological Endpoint: Cancer May 15, 1998 -- Proposition 65 |
National Toxicology Program (NTP, 1989b). Toxicology and Carcinogenesis Studies of Nalidixic Acid (CAS No. 389-08-2) in F344/N Rats and B6C3F1 Mice (Feed Studies). NTP Technical Report Series No. 368. NTIS Publication No. 90-2823. | 389-08-2 |
| Notice | Chemicals Listed Effective June 2, 2000 as Known to the State to Cause Cancer: Chloroprene, Cobalt sulfate heptahydrate, and Fenoxycarb | The Office of Environmental Health Hazard Assessment (OEHHA) of the California Environmental Protection Agency is adding three chemicals 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 (Proposition 65). The chemicals are listed effective June 2, 2000 pursuant to an administrative listing mechanism provided under Proposition 65, based upon a formal identification by an authoritative body that the chemical causes cancer. June 22, 2000 -- Proposition 65 |
National Toxicology Program (NTP, 1998a). Toxicology and Carcinogenesis Studies of Chloroprene (CAS No. 126-99-8) in F344/N Rats and B6C3F1 Mice (Inhalation Studies). Board Draft. NTP Technical Report Series No. 467 NTIS Publication No. 98-3957. | 126-99-8 |
| Notice | Chemicals Listed Effective June 2, 2000 as Known to the State to Cause Cancer: Chloroprene, Cobalt sulfate heptahydrate, and Fenoxycarb | The Office of Environmental Health Hazard Assessment (OEHHA) of the California Environmental Protection Agency is adding three chemicals 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 (Proposition 65). The chemicals are listed effective June 2, 2000 pursuant to an administrative listing mechanism provided under Proposition 65, based upon a formal identification by an authoritative body that the chemical causes cancer. June 22, 2000 -- Proposition 65 |
National Toxicology Program (NTP, 1996). Toxicology and Carcinogenesis Studies of Isobutyl Nitrite (CAS No.542-56-3) in F344/N Rats and B6C3F1 Mice (Inhalation Studies). NTP Technical Report Series No. 448. | 10026-24-1 |
| Notice | Chemicals Listed Effective December 22, 2000 as Known to the State of California to Cause Cancer or Reproductive Toxicity: Bromoethane, and 4 others | The Office of Environmental Health Hazard Assessment (OEHHA) of the California Environmental Protection Agency is adding five chemicals to the list of chemicals known to the State to cause cancer or reproductive toxicity for purposes of the Safe Drinking Water and Toxic Enforcement Act of 1986 (Proposition 65). The chemicals are listed effective December 22, 2000.
Bromoethane and isoxaflutole are listed pursuant to an administrative listing mechanism provided under Proposition 65, based upon a formal identification by an authoritative body that the chemicals cause cancer. December 22, 2000 -- Proposition 65 |
National Toxicology Program (NTP, 1989). Toxicology and Carcinogenesis Studies of Bromoethane (Ethyl Bromide) (CAS No. 74-96-4) in F344/N Rats and B6C3F1 Mice (Inhalation Studies). NTP Technical Report Series No. 363 NTIS Publication No. 90-2818. | 74-96-4 |
| Notice | Chemicals Listed Effective February 23, 2001 as Known to the State to Cause Cancer or Reproductive Toxicity: 13 chemicals | The Office of Environmental Health Hazard Assessment (OEHHA) of the California Environmental Protection Agency is adding thirteen chemicals to the list of chemicals known to the State to cause cancer or reproductive toxicity for purposes of the Safe Drinking Water and Toxic Enforcement Act of 1986 (Proposition 65). The chemicals are listed effective February 27, 2001.
Ethoprop, indium phosphide, lynestrenol, norethynodrel, and propachlor are listed pursuant to an administrative listing mechanism provided under Proposition 65, based upon a formal identification by an authoritative body that the chemicals cause cancer. February 23, 2001 -- Proposition 65 |
National Toxicology Program (NTP, 2000a). Toxicology and Carcinogenesis Studies of Indium Phosphide (CAS No. 22398-80-7) in F344/N Rats and B6C3F1 Mice (Inhalation Studies). Board Draft. NTP Technical Report Series No. 499. NTIS Publication No. 00-4433. | 22398-80-7 |
| Notice | Chemicals Delisted Effective April 6, 2001 as Known to the State to Cause Cancer | The California Environmental Protection Agency's Office of Environmental Health Hazard Assessment (OEHHA) is the lead agency for the implementation of the Safe Drinking Water and Toxic Enforcement Act of 1986 (Proposition 65). As the lead agency, OEHHA is removing saccharin from the list of chemicals known to the state to cause cancer, for purposes of Proposition 65.
Saccharin [CAS No. 81-07-2] was originally added to the Proposition 65 list on October 1, 1989. This chemical was added to the Proposition 65 list as a result of the issuance of a judicial decision enforcing Labor Code Section 6382(b)(1) and (d) which are incorporated by reference as Proposition 65 listing provisions pursuant to Health and Safety Code Section 25249.8(b). Labor Code Section 6382(b)(1) requires inclusion of substances listed as human or animal carcinogens by the International Agency for Research on Cancer (IARC). Labor Code Section 6382(d) requires the inclusion of chemicals identified as carcinogens or potential carcinogens by IARC or the National Toxicology Program (NTP). Saccharin was identified by IARC and NTP as causing cancer. April 6, 2001 -- Proposition 65 |
In 2000, NTP released its Ninth Report on Carcinogens in which it delisted saccharin [CAS No. 81 07-2] from the list of substances reasonably anticipated to be a human carcinogen. National Toxicology Program (NTP, 2000). Report on Carcinogens, Ninth Edition: Carcinogen Profiles. U.S. Department of Health and Human Services, Public Health Service, NTP, Research Triangle Park, NC.
|
81-07-2 |
| Notice | Chemical Listed Effective November 16, 2001 as Known to the State of California to Cause Cancer: Methyleugenol | The Office of Environmental Health Hazard Assessment (OEHHA) of the California Environmental Protection Agency is adding the chemical methyleugenol 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 (Proposition 65). The chemical is listed effective November 16, 2001. Toxicological Endpoint: Cancer November 16, 2001 -- Proposition 65 |
National Toxicology Program (NTP, 2000a). Toxicology and Carcinogenesis Studies ofMethyleugenol (CAS No. 93-15-2) in F344/N Rats and B6C3F1 Mice (Gavage Studies). NTP Technical Report Series No. 491 NIH Publication No. 00-3950. | 93-15-2 |
| Notice | Chemical Listed Effective April 19, 2002 as Known to the State of California to Cause Cancer: Naphthalene | The Office of Environmental Health Hazard Assessment (OEHHA) of the California Environmental Protection Agency is adding naphthalene 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 (Proposition 65). The listing of naphthalene is effective April 19, 2002. Toxicological Endpoint: Cancer April 19, 2002 -- Proposition 65 |
National Toxicology Program (NTP, 2000). Toxicology and Carcinogenesis Studies of Naphthalene (CAS No. 91-20-3) in F344/N Rats (Inhalation Studies). NTP Technical Report Series No. 500. NIH Publication No. 01-4434. | 91-20-3 |
| Notice | hemical Listed Effective May 17, 2002 as Known to the State of California to Cause Cancer: Pyridine | The Office of Environmental Health Hazard Assessment (OEHHA) of the California Environmental Protection Agency is adding pyridine 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 (Proposition 65). The listing of pyridine is effective May 17, 2002. Toxicological Endpoint: Cancer May 17, 2002 -- Proposition 65 |
National Toxicology Program (NTP, 2000). Toxicology and Carcinogenesis Studies of Pyridine (CAS No. 110-86-1) in F344/N Rats, Wistar Rats and B6C3F1 Mice (Drinking Water Studies). NTP Technical Report Series No. 470. NIH Publication No. 97-3960. | 110-86-1 |
| Notice | Chemical Listed Effective March 14, 2003 as Known to the State of California to Cause Cancer: Strong Inorganic Acid Mists Containing Sulfuric Acid | The Office of Environmental Health Hazard Assessment (OEHHA) of the California Environmental Protection Agency is adding strong inorganic acid mists containing sulfuric acid 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 (Proposition 65). The listing of strong inorganic acid mists containing sulfuric acid is effective March 14, 2003. Toxicological Endpoint: Cancer March 14, 2003 -- Proposition 65 |
National Toxicology Program (NTP, 2000). Report on Carcinogens, Ninth Edition: Carcinogen Profiles. U.S. Department of Health and Human Services, Public Health Service, NTP, Research Triangle Park, NC. | 7664-93-9 (Mists containing) |
| Notice | Chemical Listed Effective November 14, 2003 as Known to the State of California to Cause Cancer: Fumonisin B1 | The Office of Environmental Health Hazard Assessment (OEHHA) of the California Environmental Protection Agency is adding fumonisin B1 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 (Proposition 65). The listing of fumonisin B1 is effective November 14, 2003 Toxicological Endpoint: Cancer November 14, 2003 -- Proposition 65 |
National Toxicology Program (NTP, 2001). Toxicology and Carcinogenesis Studies of Fumonisin B1 (CAS No. 116355-83-0) in F344/N Rats and B6C3F1 Mice (Feed Studies). NTP Technical Report Series No. 496, NIH Publication No. 01-3955 | 116355-83-0 |
| 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 7, 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 | 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 | 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 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 9, 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 | 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 3, 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 | 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 7, 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 February 11, 2005 as Known to the State of California to Cause Cancer: Vanadium Pentoxide | The Office of Environmental Health Hazard Assessment (OEHHA) of the California Environmental Protection Agency is adding vanadium pentoxide (orthorhombic crystalline form) 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 the chemical is effective February 11, 2005.
Toxicological Endpoint: Cancer
February 11, 2005 -- Proposition 65 |
National Toxicology Program (NTP, 2002). Toxicology and Carcinogensis Studies of Vanadium Pentoxide (CAS No. 1314-62-1) in F344/N Rats and B6C3F1 Mice (Inhalation). NTP Technical Report Series No. 507. NIH Publication No. 03-4441. U.S. Department of Health and Human Services, Public Health Service, National Institutes of Health, NTP, Research Triangle Park, NC. | 1314-63-1 |
| Notice | Chemicals Listed Effective May 20, 2005 as Known to the State of California to Cause Cancer: Cobalt sulfate, Diazoaminobenzene | The Office of Environmental Health Hazard Assessment (OEHHA) of the California Environmental Protection Agency is adding cobalt sulfate (CAS No. 10124-43-3) and diazoaminobenzene (CAS No. 136-35-6) 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 cobalt sulfate and diazoaminobenzene is effective May 20, 2005. Toxicological Endpoint: cancer May 20, 2005 -- Proposition 65 |
National Toxicology Program (NTP, 2004). Report on Carcinogens, Eleventh Edition. Carcinogen Profiles. U.S. Department of Health and Human Services, Public Health Service. National Institute of Environmental Health Sciences, Research Triangle Park, NC. | 10124-43-3 |
| Notice | Chemicals Listed Effective May 20, 2005 as Known to the State of California to Cause Cancer: Cobalt sulfate, Diazoaminobenzene | The Office of Environmental Health Hazard Assessment (OEHHA) of the California Environmental Protection Agency is adding cobalt sulfate (CAS No. 10124-43-3) and diazoaminobenzene (CAS No. 136-35-6) 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 cobalt sulfate and diazoaminobenzene is effective May 20, 2005. Toxicological Endpoint: cancer May 20, 2005 -- Proposition 65 |
NTP concluded that diazoaminobenzene (DAAB) is reasonably anticipated to be a human carcinogen based on evidence from studies in animals and with human tissue demonstrating that DAAB is metabolized to benzene, a known human carcinogen, and on evidence that DAAB causes genetic damage.
National Toxicology Program (NTP, 2004). Report on Carcinogens, Eleventh Edition. Carcinogen Profiles. U.S. Department of Health and Human Services, Public Health Service. National Institute of Environmental Health Sciences, Research Triangle Park, NC.
|
136-35-6 |
| Notice | Chemicals Listed Effective May 27, 2005 and May 31, 2005 as known to the State of California to Cause Cancer or Reproductive Toxicity | The Office of Environmental Health Hazard Assessment (OEHHA) of the California Environmental Protection Agency is adding 2-bromopropane (2-BP) (CAS No. 75-26-3)...to the list of chemicals known to the state to cause cancer or reproductive toxicity 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... 2-bromopropane (2-BP) is effective May 31, 2005.
Toxicological endpoint: Female reproductive and male reproductive toxicity May 31, 2005 -- Proposition 65 |
National Toxicology Program - Center for the Evaluation of Risks to Human Reproduction (NTP-CERHR, 2003). NTP-CERHR Monograph on the Potential Human Reproductive and Developmental Effects of 2-Bromopropane . NIH Publication No. 04-4480. U.S. Department of Health and Human Services, Public Health Service, National Institutes of Health, NTP, Research Triangle Park, NC. | 75-26-3 |
| Notice | Chemicals Listed Effective August 19, 2005 as Known to the State of California to Cause Cancer: estrogens, steroidal | The Office of Environmental Health Hazard Assessment (OEHHA) of the California Environmental Protection Agency is adding estrogens, steroidal 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 estrogens, steroidal is effective August 19, 2005. August 19, 2005 -- Proposition 65 |
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. | Steroidal Estrogens (as a class) |
| Notice | Chemicals Listed Effective December 2, 2005 as Known to the State of California to Cause Reproductive Toxicity: butyl benzyl phthalate (BBP) (CAS No. 85 68-7), di-n-butyl phthalate (DBP) (CAS No. 84-74-2), and di-n-hexyl phthalate (DnHP) (CAS No. 84-75-3) | The Office of Environmental Health Hazard Assessment (OEHHA) of the California Environmental Protection Agency is adding butyl benzyl phthalate (BBP) (CAS No. 85 68-7), di-n-butyl phthalate (DBP) (CAS No. 84-74-2), and di-n-hexyl phthalate (DnHP) (CAS No. 84-75-3) 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., commonly known as Proposition 65). The listing of the three phthalates is effective December 2, 2005 Toxicological endpoint: cancer. Toxicological endpoints: Developmental toxicity December 2, 2005 -- Proposition 65 |
National Toxicology Program Center for the Evaluation of Risks to Human Reproduction (NTP-CERHR, 2003a). NTP-CERHR Monograph on the Potential Human Reproductive and Developmental Effects of Butyl Benzyl Phthalate (BBP). NIH Publication No. 03-4487. | 85-68-7 |
| Notice | Chemicals Listed Effective December 2, 2005 as Known to the State of California to Cause Reproductive Toxicity: butyl benzyl phthalate (BBP) (CAS No. 85 68-7), di-n-butyl phthalate (DBP) (CAS No. 84-74-2), and di-n-hexyl phthalate (DnHP) (CAS No. 84-75-3) | The Office of Environmental Health Hazard Assessment (OEHHA) of the California Environmental Protection Agency is adding butyl benzyl phthalate (BBP) (CAS No. 85 68-7), di-n-butyl phthalate (DBP) (CAS No. 84-74-2), and di-n-hexyl phthalate (DnHP) (CAS No. 84-75-3) 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., commonly known as Proposition 65). The listing of the three phthalates is effective December 2, 2005 Toxicological endpoint: cancer. Toxicological endpoints: Developmental toxicity, Female reproductive toxicity, and Male reproductive toxicity
December 2, 2005 -- Proposition 65 |
National Toxicology Program Center for the Evaluation of Risks to Human Reproduction (NTP-CERHR, 2003b). NTP-CERHR Monograph on the Potential Human Reproductive and Developmental Effects of Di-n-Butyl Phthalate (DBP). NIH Publication No. 03-4486. | 84-74-2 |
| Notice | Chemicals Listed Effective December 2, 2005 as Known to the State of California to Cause Reproductive Toxicity: butyl benzyl phthalate (BBP) (CAS No. 85 68-7), di-n-butyl phthalate (DBP) (CAS No. 84-74-2), and di-n-hexyl phthalate (DnHP) (CAS No. 84-75-3) | The Office of Environmental Health Hazard Assessment (OEHHA) of the California Environmental Protection Agency is adding butyl benzyl phthalate (BBP) (CAS No. 85 68-7), di-n-butyl phthalate (DBP) (CAS No. 84-74-2), and di-n-hexyl phthalate (DnHP) (CAS No. 84-75-3) 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., commonly known as Proposition 65). The listing of the three phthalates is effective December 2, 2005 Toxicological endpoint: cancer. Toxicological endpoints: female reproductive toxicity and male reproductive toxicity December 2, 2005 -- Proposition 65 |
National Toxicology Program Center for the Evaluation of Risks to Human Reproduction (NTP-CERHR, 2003c). NTP-CERHR Monograph on the Potential Human Reproductive and Developmental Effects of Di-n-Hexyl Phthalate (DnHP). NIH Publication No. 03-4489. | 84-75-3 |
| Notice | Chemicals Delisted Effective December 8, 2006 from the List of Chemicals Known to the State of California to Cause Cancer, isosafrole, 5-nitro-o-anisidine, tris(aziridinyl)-p-benzoquinone | The Office of Environmental Health Hazard Assessment (OEHHA) of the California Environmental Protection Agency is removing isosafrole [CAS No. 120-58-1], 5-nitro-o-anisidine [CAS No. 99-59-2], and tris(aziridinyl)-p-benzoquinone (triaziquone) [CAS No. 68-76-8] from the list of chemicals known to the State to cause cancer for purposes of the Safe Drinking Water and Toxic Enforcement Act of 1986 (Proposition 65). The delisting of the three chemicals is effective December 8, 2006. 5-Nitro-o-anisidine was removed from the NTP Sixth Annual Report on Carcinogens as a substance reasonably anticipated to be a human carcinogen in 1991, when NTP concluded there was insufficient evidence of carcinogenicity. December 8, 2006 -- Proposition 65 |
Report on Carcinogens, Eleventh Edition (2004); Appendix B; National Toxicology Program, U.S. Department of Helath and Human Services, Research Triangle Park, NC | 99-59-2 |
| Notice | Chemical Listed Effective September 28, 2007 as Known to the State of California to Cause Cancer: anthraquinone (CAS No. 84-65-1) | The Office of Environmental Health Hazard Assessment (OEHHA) within the California Environmental Protection Agency is adding anthraquinone (CAS No. 84-65-1) 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., commonly known as Proposition 65). The listing of anthraquinone is effective September 28, 2007.
Anthraquinone (CAS No. 84-65-1) is being listed as a chemical known to the State of California to cause cancer. The listing of this chemical is based on formal identification by an authoritative body (i.e., the National Toxicology Program (NTP)), that the chemical causes cancer. The criteria used by OEHHA for the listing of chemicals under the authoritative bodies mechanism can be found in Title 22, Cal. Code of Regs., section 12306.
Toxicological endpoint: cancer September 28, 2007 -- Proposition 65 |
National Toxicology Program (NTP, 2005). Toxicology and Carcinogenesis Studies of Anthraquinone (CAS No. 84-65-1) in F344/N Rats and B6C3F1 Mice (Feed Studies). NTP Technical Report Series No. 494. NIH Publication No. 05-3953. U.S. Department of Health and Human Services, Public Health Service, National Institutes of Health, NTP, Research Triangle Park, NC. Also listed in the 11th Report on Carcinogens (2004) as reasonably anticipated to be a human carcinogen. | 84-65-1 |
| Notice | Chemical Listed Effective June 17, 2008 as Known to the State of California to Cause Cancer, Dibromoacetic acid (CAS No. 631-64-1) | The Office of Environmental Health Hazard Assessment (OEHHA) within the California Environmental Protection Agency is adding dibromoacetic acid (CAS No. 631-64-1) 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., commonly known as Proposition 65). The listing of dibromoacetic acid is effective June 17, 2008. Toxicological endpoints: Reproductive Toxicity and Cancer June 13, 2008 -- Proposition 65 |
National Toxicology Program (NTP, 2007). Toxicology and Carcinogenesis Studies of Dibromoacetic Acid (CAS No. 631-64-1) in F344/N Rats and B6C3F1 Mice (Drinking Water Studies). NTP Technical Report Series No. 537. NIH Publication No. 07-4475 | 631-64-1 |
| Notice | Chemical meeting the criteria for listing Via the authoritative bodies mechanism: Methanol | A chemical may be listed under the Safe Drinking Water and Toxic Enforcement Act of 1986 (commonly known as Proposition 65; codified at Health and Safety Code section 25249.5 et seq.) when a body considered to be authoritative by the states qualified experts has formally identified the chemical as causing cancer or reproductive toxicity. The following entities are identified as authoritative bodies for this purpose: the U.S. Environmental Protection Agency, the International Agency for Research on Cancer, the U.S. Food and Drug Administration, the National Institute for Occupational Safety and Health, and the National Toxicology Program January 2, 2009 -- Proposition 65 |
National Toxicology Program Center for the Evaluation of Risks to Human Reproduction (NTP-CERHR, 2003). NTP-CERHR Monograph on the Potential Human Reproductive and Developmental Effects of Methanol. NIH Publication No. 04-4478 | 67-56-1 |
| Total Notices | 42 | |||
| Notice Type | Title | Summary of Notice | NTP Information Cited | CAS Number |
|---|---|---|---|---|
| Proposed Rule | Urea Formaldehyde Foam Insulation | CPSC proposed rule to ban manufacture or sale in the US. February 5, 1981 -- 46 FR 11188 |
NIEHS participation on Task Force to verify findings concerning carcinogenicity of urea formaldehyde. | 50-00-0 |
| Final Rule | Urea Formaldehyde Foam Insulation | CPSC final rule banning UF foam insulation in residences and schools. April 2, 1982 -- 47 FR 14366 |
Statement by the Director of NIEHS that Formaldehyde is an animal carcinogen is cited in support of the ban. | 50-00-0 |
| Final Rule | Dioxin-containing Wastes | Issued guidelines specifying criteria for determining when any customary or reasonably foreseeable use of an art material can result in chronic hazard. October 9, 1992 -- 57 FR 46624 |
NTP criteria for assessing the quality and adequacy of animal studies. | N/A |
| Proposed | Standard for the Flammability (Open Flame) of Mattresses and Mattress/Foundation Sets; Notice of Proposed Rulemaking | The Commission is proposing a flammability standard under the authority of the Flammable Fabrics Act that would address open flame ignition of mattresses and mattress and foundation sets ("mattresses/sets"). January 13, 2005 -- 70 FR 2470 |
Additional activities by EPA, The National Toxicology Program (NTP) of the Department of Health and Human Services (DHHS), and the Occupational Safety and Health Administration (OSHA) can provide information about any adverse health effects of FR chemicals and take actions to limit their use if necessary. | N/A |
| Notice | Standard for the Flammability of Residential Upholstered Furniture | The United States Consumer Product Safety Commission (Commission or CPSC) is proposing flammability standards for residential upholstered furniture under the Flammable Fabrics Act (FFA). The proposal would establish performance requirements and certification and labeling requirements for upholstered furniture. Manufacturers of upholstered furniture would choose one of two possible methods of compliance: They could use cover materials that are sufficiently smolder resistant to meet a cigarette ignition performance test; or they could place fire barriers that meet smoldering and open flame resistance tests between the cover fabric and interior filling materials. Manufacturers of upholstered furniture would be required to certify compliance with the standard and to comply with certain recordkeeping requirements as specified in the proposal. March 4, 2008 -- 73 FR 11702 |
At the request of the staff, the National Toxicology Program (NTP) of the Department of Health and Human Services has undertaken a review of several FRs that could be used to meet CPSC flammability rules. The NTP review will be a relatively long-term project that contributes to the overall level of knowledge about FR chemicals among scientists and regulators. | NA |
| Total Notices | 5 | |||
| Notice Type | Title | Summary of Notice | NTP Information Cited | CAS Number |
|---|---|---|---|---|
| Final Rule | Diesel Particulate Matter Exposure of Underground Coal Miners | The Department of Labor is establishing new health standards for underground coal mines that use equipment powered by diesel engines. High concentrations of diesel particulate matter (DPM) increases the risk of serious health hazards in underground mines. January 19, 2001 -- 66 FR 5525 |
The NTP is listed as one of many scientific organizations and governmental agencies that has reviewed the available epidemiologic and toxicological evidence for carcinogenicity and has identified dpm as a probable human carcinogen. (9th Report on Carcinogens) | N/A |
| Notice | International Conference on Harmonisation; Draft Recommendations for the Revision of the Permitted Daily Exposures for Two Solvents,N-Methylpyrrolidone and Tetrahydrofuran. | The Department of Labor is proposing revising the existing diesel particulate matter (DPM) interim concentration limit. August 14, 2003 -- 68 FR 48668 |
A published review of the particulate inhalation studies conducted by the NTP was used to update the toxicological effects of DPM exposure. | N/A |
| Final Rule | Diesel Particulate Matter Exposure of Underground Metal and Nonmetal Miners | In this final rule: MSHA revises the existing standards addressing diesel particulate matter (DPM) exposure in underground metal and nonmetal (M/NM) mines; changes the interim concentration limit measured by total carbon to a comparable permissible exposure limit measured by elemental carbon, which renders a more accurate DPM exposure measurement; increases flexibility of compliance for mine operators by requiring longstanding hierarchy of controls for its other exposure-based health standards at M/NM mines, but retains the prohibition on rotation of miners for compliance; requires MSHA to consider economic as well as technological feasibility in determining if operators qualify for an extension of time in which to meet the final DPM limit; deletes the requirement for a control plan; and makes conforming changes to existing provisions concerning compliance determinations, environmental monitoring and recordkeeping. June 6, 2005 -- 70 FR 32868 |
Moyer, et al. review of NTP data from 90-day and 2-yr exposures of particulates and use of mouse inhalation model and the NTP 10th edition of the Report on Carcinogens are cited in the MSHA revision of existing standards addressing diesel particulate matter (DPM) exposure in underground metal and nonmetal (M/NM) mines. (ROC). |
N/A |
| Total Notices | 3 | |||
| Notice Type | Title | Summary of Notice | NTP Information Cited | CAS Number |
|---|---|---|---|---|
| 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 |
| Total Notices | 2 | |||
| Notice Type | Title | Summary of Notice | NTP Information Cited | CAS Number |
|---|---|---|---|---|
| Proposed Rule | Chloromethane and Chlorinated Benzenes | EPA proposed rule to require testing under TSCA Section 4. July 18, 1980 -- 45 FR 48524 |
NTP has selected 1,4-Dichlorobenzene for teratogenicity testing. | 106-46-7 |
| Other | Asbestos | EPA proposed rule to require schools to identify friable asbestos-containing materials and to notify employees and PTAs. September 17, 1980 -- 45 FR 61966 |
NIEHS-sponsored studies of effects of asbestos exposure. | 1332-21-4 |
| Other | Alkyl Phthalate and Benzyl Butyle Phthalate | EPA notice of preliminary decision not to require testing under TSCA, following receipt of CMA testing proposal. October 30, 1981 -- 46 FR 53775 |
NTP conducting mutagenicity, oncogenicity, and reproductive and mitochondrial effects studies of various alkyl phthalate esters. | 85-68-7 |
| Notice | Benzidine, o-Tolidine, o-Dianisidine | EPA notice that testing under TSCA Section 4 is not required due to adequacy of current testing programs of NTP and other federal agencies. November 5, 1981 -- 46 FR 55004 |
Current and planned testing by NTP cited. | 92-87-5 119-93-7 |
| Notice | Chlorinated Paraffins | EPA notice that testing under TSCA Section 4 is not being required because currently planned testing is sufficient. January 8, 1982 -- 47 FR 1017 |
NTP bioassays of two chlorinated paraffin compounds. (TR-305) (TR-308) | 108171-27-3 108171-26-2 |
| Final Rule | Asbestos | EPA final rule requiring schools to identify friable asbestos-containing building materials, to maintain records, and to notify employees and PTA's. May 27, 1982 -- 47 FR 23360 |
Reference to report on Amosite, Chrysotile, Crocidolite and nonfibrous Tremolite for NIEHS oral ingestion studies. | 12001-28-4 12001-29-5 14567-73-8 1332-21-4 12172-73-5 |
| Notice | Xylenes | EPA notice that testing under TSCA Section 4 is not warranted. December 16, 1982 -- 47 FR 56392 |
NTP cancer bioassay and teratogenicity study of mixed Xylenes. | 1330-20-7 |
| Notice | Toluene | EPA notice that a test rule under TSCA Section 4 is unnecessary because information from current and planned testing will be sufficient. December 16, 1982 -- 47 FR 56391 |
NTP has completed a subchronic oral study and NTP/NCI carcinogenesis testing program is starting chronic studies. | 108-88-3 |
| Notice | Acetonitrile | EPA notice that testing by NTP and manufacturers is adequate and further testing under TSCA Section 4 is not warranted. December 29, 1982 -- 47 FR 58020 |
NTP chronic and mutagenic effects testing, together with manufacturers' testing, make it unnecessary to require Section 4A testing. (TR-447) | 75-05-8 |
| Notice | Pyridine | EPA notice that testing under TSCA Section 4 is not warranted. December 29, 1982 -- 47 FR 58031 |
Sufficient data have been or are being developed on Pyridine for carcinogenicity and chronic effects by the NTP. (TR-283) | 110-86-1 |
| Notice | Hexachlorocyclopentadiene | EPA notice that testing under TSCA Section 4 is not warranted. December 29, 1982 -- 47 FR 58023 |
NTP is conducting a 2-year inhalation oncogenicity bioassay. (TR-437) | 77-47-4 |
| Notice | Isophorone | EPA notice that it is not initiating TSCA Section 4A test requirements because of adequate ongoing tests. January 6, 1983 -- 48 FR 727 |
NTP long-term bioassay, together with manufacturers' tests, make it unnecessary to require Section 4A testing. (TR-291) | 78-59-1 |
| Notice | Formamide | EPA notice of determination not to require additional health effects testing. May 23, 1983 -- 48 FR 23098 |
NTP genotoxicity testing, together with importer's subchronic effects testing, make it unnecessary to require Section 4A testing. | 75-12-7 |
| Notice | 4,4-Methylenedianiline | EPA notice that it is not initiating a TSCA Section 4A health effects test rule because recent NTP study shows MDA to be carcinogenic in rats and mice. July 11, 1983 -- 48 FR 31806 |
The data from the NTP bioassay are sufficient...and further oncogenicity testing is unnecessary. (TR-248) | 13552-44-8 |
| Notice | 4,4-Methylenedianiline | EPA ANPR of EPA/OSHA joint initiation of regulatory action under TSCA and OSHA Act. September 20, 1983 -- 48 FR 42898 |
NTP bioassay indicated that the dihydrochloride salt of 4,4-MDA is carcinogenic in both sexes of rats and mice. (TR-248) | 13552-44-8 |
| Notice | Tris | EPA notice that it is not initiating TSCA Section 4A test requirement rulemaking because ongoing tests are expected to provide sufficient information to predict toxicity. November 14, 1983 -- 48 FR 51842 |
NTP testing of compounds containing the 2-ethylhexyl moiety. (TR-274) | 78-42-2 |
| Notice | Bis(2-Ethylhexyl)Terephthalate; Response to the Interagency Testing Committee | EPA notice that it is not initiating TSCA Section 4 test requirement rulemaking because ongoing tests are expected to provide sufficient information to predict toxicity. November 14, 1983 -- 48 FR 51845 |
Two chemicals similar to metabolites of DOTP have been nominated for genotoxicity testing by the NTP. | 104-76-7 4376-20-9 |
| Notice | Formaldehyde | EPA notice of reconsideration as to whether TSCA Section 4f priority consideration is appropriate. November 18, 1983 -- 48 FR 52507 |
Federal Panel on Formaldehyde, formed by several agencies under the aegis of NTP, reviewed study of Formaldehyde. | 50-00-0 |
| Proposed Rule | Chlorinated Benzenes | EPA proposed rule to withdraw most testing requirements. December 7, 1983 -- 48 FR 54836 |
NTP mutagenesis testing of Monochlorobenzene; 1,2,4-Trichlorobenzene and Pentachlorobenzene. NTP toxicity testing of Monochlorobenzene,ortho and para-Dichlorobenzenes. (TR-255) (TR-261) | 120-82-1 108-90-7 608-93-5 95-50-1 |
| Proposed Rule | Cyromazine | EPA issuance of emergency exemptions for use of an unregistered pesticide. December 14, 1983 -- 48 FR 55624 |
Applicant's earlier request for specific exemption was denied because of results of NTP study of Melamine, a metabolite of Cyromazine. | 108-78-1 |
| Proposed Rule | Hexafluoropropylene Oxide | EPA proposed test rule under TSCA Section 4. December 30, 1983 -- 48 FR 57686 |
NTP planning to conduct Ames assay. | 428-59-1 |
| Notice | Ethylene Oxide | EPA notice of determination not to require testing. January 3, 1984 -- 49 FR 200 |
NTP chronic inhalation bioassay. (TR-326) | 75-21-8 |
| Other | Anilines | EPA ANPR to require health and environmental effects testing. January 3, 1984 -- 49 FR 108 |
NTP confirmatory study of effects of dietary exposure to 4-Chloroaniline Hydrochloride. (TR-351) | 20265-96-7 |
| Notice | 1,2-Butylene Oxide | EPA notice of determination not to require testing. January 4, 1984 -- 49 FR 503 |
NTP inhalation bioassay of 1,2-butylene oxide. (TR-329) | 106-88-7 |
| Proposed Rule | Hydroquinone | EPA Proposed test rule under TSCA Section 4. January 4, 1984 -- 49 FR 438 |
EPA is not proposing oncogenicity testing of Hydroquinone since NTP is currently conducting a 2-year bioassay. (TR-366) | 123-31-9 |
| Other | Certain Alkyl Epoxides | EPA ANPR on testing under TSCA January 4, 1984 -- 49 FR 449 |
NTP subchronic study on 1,2-Epoxyhexadecane applied dermally. | 7320-37-8 |
| Proposed Rule | 1,2-Dichloropropane | EPA proposed test rule January 6, 1984 -- 49 FR 899 |
NTP 2-year bioassay (TR-263) | 78-87-5 |
| Notice | Isophorone | EPA notice of decision to adopt negotiated testing program. January 17, 1984 -- 49 FR 2012 |
NTP's initiation of a long-term bioassay, together with CMA proposed testing, make it unnecessary to require TSCA Section 4 testing. (TR-291) | 78-59-1 |
| Proposed Rule | Cyromazine | EPA proposed temporary feed additive regulation. April 27, 1984 -- 49 FR 18130 |
NTP bioassay of Melamine, a metabolite of Cyromazine, showed significant increase in bladder carcinomas in male rats. (TR-245) | 108-78-1 |
| Notice | Cyromazine | EPA notice of proposed conditional registration under FIFRA for temporary period. April 27, 1984 -- 49 FR 18172 |
As a result of the reported oncogenicity of Melamine in the NTP bioassay, the agency stopped the Cyromazine registration process...until it could review the NTP bioassay. (TR-245) | 108-78-1 |
| Notice | Cyromazine | EPA proposed rule to establish feed additive regulation setting temporary maximum permissible residue level in poultry feed. April 27, 1984 -- 49 FR 18120 |
NTP bioassay of Melamine, a metabolite of Cyromazine, showed a significant increase in bladder carcinomas in male rats. (TR-245) | 108-78-1 |
| Other | 1,3-Butadiene | EPA ANPR and invitation to submit data on controlling exposures, following recent bioassays establishing carcinogenicity. May 15, 1984 -- 49 FR 20524 |
NTP chronic oncology studies show carcinogenicity in both sexes of rats and mice; NTP planning further teratology testing. (TR-288) | 106-99-0 |
| Notice | Calcium, Cobalt, and Lead Napthenates | EPA notice of determination not to require testing. May 21, 1984 -- 49 FR 21411 |
NTP planning testing of cobalt naphthenate and cobalt sulfate; NTP currently testing naphthenic acid; NTP has completed mutagenicity tests of lead naphthenate. | 10124-43-3 61789-51-3 |
| Other | Formaldehyde | EPA ANPR announcing decision that TSCA Section 4f priority consideration is applicable in 2 exposure categories, and initiating a regulatory investigation. May 23, 1984 -- 49 FR 21870 |
Federal Panel on Formaldehyde, under the aegis of NTP, reviewed CIIT's bioassay methodology from CIIT inhalation study showing nasal cancer in rats. | 50-00-0 |
| Notice | Toluene | EPA notice of decision not to regulate under CAA based on studies showing toluene not to pose a significant risk to public health. This decision is not relevant to regulation of toluene as a VOC under the air quality standards for ozone. May 25, 1984 -- 49 FR 22195 |
NTP is currently conducting a lifetime bioassay on toluene. (TR-371) | 108-88-3 |
| Proposed Rule | Fluoroalkenes | EPA notice of proposed decision to adopt a negotiated testing program in lieu of required testing. June 4, 1984 -- 49 FR 23112 |
NTP planning testing of tetrafluoroethane and vinylidene. (TR-228) | 75-35-4 |
| Notice | Bis(2-Ethylhexyl) Terephthalate | EPA notice of decision to adopt negotiated testing program. June 4, 1984 -- 49 FR 23110 |
NTP has nominated two chemicals similar to the metabolites of DOTP for genotoxicity testing. | 104-76-7 4376-20-9 |
| Proposed Rule | Volatile Synthetic Organic Chemicals | EPA proposed rule for National Primary Drinking Water Regulations establishing Recommended Maximum Contaminant Levels for several VOC's. June 12, 1984 -- 49 FR 24330 |
NTP studies of trichlorethylene; 1,1,1-trichlorethane; 1,1-dichloroethylene; and p-dichlorobenzene. (TR-319) (TR-228) (TR-243) (TR-273) (TR-262) | 106-46-7 79-01-6 71-55-6 75-35-4 |
| Proposed Rule | Dichloromethane | EPA proposed rule to withdraw testing requirements under TSCA. Evaluation of data indicates dichloromethane does not present unreasonable risks. June 19, 1984 -- 49 FR 25009 |
EPA expects NTP inhalation bioassay to be sufficient to characterize oncogenic hazards. (TR-306) | 75-09-2 |
| Proposed Rule | Nitrobenzene | EPA proposed rule to withdraw testing requirements under TSCA. Ongoing government and manufacturers' tests are expected to meet all testing. June 19, 1984 -- 49 FR 25013 |
EPA concluded that NTP oncogenicity and subchronic effects testing would be sufficient and so didn't require further testing for these effects. | 98-95-3 |
| Final Rule | 1,1,1-Trichloroethane | EPA final rule identifying specific chemical substance and mixture testing requirements. October 10, 1984 -- 49 FR 39810 |
EPA did not propose chronic effects or oncogenicity testing because an NTP study is expected to provide sufficient information. (TR-262) | 71-55-6 |
| Proposed Rule | [(Dinitrophenyl)Azo]-[2,4-Diamino-5-Methoxybenzene] Derivatives; Proposed Determination of Significant New Uses | EPA proposed rule promulgating a significant new use rule under TSCA Section 5. October 25, 1984 -- 49 FR 42960 |
NTP and others have shown carcinogenic potential of close structural analogues of phenylenediamines. | N/A |
| Proposed Rule | Certain Polyamino Chemical Substances | EPA proposed rule promulgating a significant new use rule under TSCA Section 5. December 27, 1984 -- 49 FR 50209 |
NTP bioassay indicated that the dihydrochloride salt of Methylenedianiline is carcinogenic in both sexes of rats and mice. (TR-248) | 13552-44-8 |
| Final Rule | Dioxin-containing Wastes | EPA final rule listing certain dioxin-containing wastes as acute hazardous wastes. January 14, 1985 -- 50 FR 1978 |
Re-evaluation by NTP of NCI study of HXCDD. (TR-202) | 57653-85-7 |
| Proposed Rule | Reportable Quantity Adjustments | EPA proposed rule adjusting reportable quantities of hazardous substances released by facilities or vessels. April 4, 1985 -- 50 FR 13514 |
EPA identified potential carcinogens by use of NTP Annual Report on Carcinogens and IARC Monographs. | N/A |
| Notice | Methylene Chloride | EPA notice of initiation of accelerated review under TSCA Section 4. May 14, 1985 -- 50 FR 20126 |
NTP inhalation studies demonstrated carcinogenicity. (TR-306) | 75-09-2 |
| Notice | Cyromazine | EPA notice of determination to issue conditional registration under FIFRA. May 15, 1985 -- 50 FR 20373 |
NTP bioassay demonstrated that high dose ingestion induced cancer. NTP study of Melamine, a metabolite of Cyromazine. (TR-245) | 108-78-1 |
| Final Rule | 2-Ethylhexanoic Acid | EPA proposed rule on testing under TSCA Section 4. May 17, 1985 -- 50 FR 20679 |
NTP tests of four chemicals containing 2-ethylhexyl showed them to be animal oncogenes; NTP plans test of 2-ethylhexanol. | 104-76-7 |
| Proposed Rule | Bisphenol A | EPA proposed rule on testing under TSCA Section 4. May 17, 1985 -- 50 FR 20691 |
"EPA finds that sufficient data are available from the NTP bioassay report to reasonably predict that ingested BPA is not oncogenic...EPA believes appropriate developmental toxicity testing has been conducted at NTP." (TR-215) | 80-05-7 |
| Final Rule | Diethylenetriamine | EPA final rule on testing requirements under TSCA Section 4. May 23, 1985 -- 50 FR 21398 |
NTP conducted Ames Salmonella/Microsome Plate Test with negative results. | 111-40-0 |
| Notice | Methyl Chloroform | EPA notice of assessment as a potentially toxic air pollutant and determination that regulation under CAA is not warranted. June 10, 1985 -- 50 FR 24314 |
EPA awaiting results of NTP carcinogenicity bioassay. (TR-262) | 71-55-6 |
| Proposed Rule | 4,4-Methylenedianiline | EPA notice of decision to refer to OSHA under TSCA Section 9. July 5, 1985 -- 50 FR 27674 |
NTP study demonstrated that dihydrochloride salt of 4,4-MDA is carcinogenic in both sexes of rats and mice. (TR-248) | 13552-44-8 |
| Notice | Chlorinated Benzenes | EPA notice of intent not to regulate chlorinated benzenes under CAA. August 13, 1985 -- 50 FR 32628 |
NTP carcinogenesis testing of 1,4-dichlorobenzene is currently underway. (TR-319) | 106-46-7 |
| Other | Manganese | EPA decision not to regulate manganese under CAA. August 13, 1985 -- 50 FR 32627 |
Regulation not needed at this time because NTP has scheduled carcinogenicity testing and is conducting mutagenicity studies. (TR-428) | 10034-96-5 |
| Proposed Rule | Benzyl Butyl Phthalate | EPA proposed test rule. September 6, 1985 -- 50 FR 36446 |
NTP planned reproduction effects and cancer studies make it unnecessary to require health effects testing at this time. (TR-458) | 85-68-7 |
| Notice | Chloroprene | EPA notice of intent not to regulate and solicitation of information. September 27, 1985 -- 50 FR 39632 |
Ongoing NTP carcinogenicity and reproductive hazard study. | 126-99-8 |
| Notice | Hexachlorocyclopentadiene | EPA notice of intent not to regulate and solicitation of information. October 1, 1985 -- 50 FR 40154 |
Ongoing NTP study. (TR-437) | 77-47-4 |
| Other | Dioxin-containing wastes | EPA tentative denial of petition to amend the rule listing certain dioxin-containing wastes as acute hazardous wastes. October 8, 1985 -- 50 FR 41125 |
Reference to NCI/NTP bioassay of HXCDD. (TR-202) | 57653-85-7 |
| Notice | 1,3-Butadiene | EPA notice of intent to list under CAA Section 112 as a potentially toxic air pollutant. October 10, 1985 -- 50 FR 41466 |
Reference to NTP mouse study which was prematurely terminated due to excess deaths. | 106-99-0 |
| Other | 1,3-Butadiene | EPA referral to OSHA under TSCA Section 9. October 10, 1985 -- 50 FR 41393 |
Reference to NTP report on toxicological and carcinogenesis studies. (TR-288) | 106-99-0 |
| Other | Methylene Chloride | EPA ANPR announcing initiation of comprehensive regulatory investigation. October 17, 1985 -- 50 FR 42037 |
NTP inhalation bioassay demonstrated carcinogenicity in two species. (TR-306) | 75-09-2 |
| Proposed Rule | 2-Mercaptobenzothiazole | EPA proposed rule requiring testing under TSCA Section 4. November 6, 1985 -- 50 FR 46121 |
NTP carcinogenesis study in progress. (TR-332) | 149-30-4 |
| Proposed Rule | Fluoroalkenes | EPA proposed rule requiring testing. November 6, 1985 -- 50 FR 46133 |
NTP study of vinylidene fluoride. | 75-38-7 |
| Proposed Rule | Synthetic Organic Chemicals, Inorganic Chemicals, and Microorganisms | EPA proposed rule to establish Recommended Maximum Contaminant Levels as part of the National Primary Drinking Water Regulation under the Safe Drinking Water Act. November 13, 1985 -- 50 FR 46936 |
NTP studies of 1,2-dichloropropane; monochlorobenzene; dichlorobenzene; 1,2 dibromoethane; pentachlorophenol; toluene; xylene; 2,3,7,8-TCDD; and ingestion of asbestos. (TR-327) (TR-371) (TR-319) (TR-263) (TR-349) (TR-255) (TR-210) (TR-261) | 1330-20-7 108-88-3 106-46-7 78-87-5 1746-01-6 87-86-5 95-50-1 106-93-4 108-90-7 12001-28-4 12001-29-5 12172-73-5 14567-73-8 |
| Final Rule | Volatile Synthetic Organic Chemicals | EPA final rule promulgating National Primary Drinking Water regulations. November 13, 1985 -- 50 FR 46880 |
NTP rat and mice inhalation bioassay of tetrachloroethylene demonstrated carcinogenicity in both species. NTP gavage bioassay of p-dichlorobenzene showed carcinogenicity in both sexes of mice and female rats showed no evidence of carcinogenicity. (TR-319) (TR-311) | 106-46-7 127-18-4 |
| Notice | Volatile Synthetic Organic Chemicals | EPA notice of new evidence and requests for comment on new NTP report on tetrachloroethylene. November 13, 1985 -- 50 FR 47025 |
EPA reopened comment period specifically to provide opportunity for comment on NTP report. | 127-18-4 |
| Proposed Rule | Pentabromoethylbenzene | EPA proposed rule on testing under TSCA Section 4. November 13, 1985 -- 50 FR 46785 |
NTP tests were performed using Salmonella typhimurium. | 85-22-3 |
| Final Rule | Propylene Oxide | EPA final rule to require testing for developmental toxicity under TSCA Section 4. November 27, 1985 -- 50 FR 48762 |
NTP 2-year studies on rats and mice demonstrated evidence of carcinogenicity. (TR-267) | 75-56-9 |
| Proposed Rule | Hazardous Waste Management System | EPA proposed rule to list used oil as hazardous waste. November 29, 1985 -- 50 FR 49258 |
Reference to two NTP perchloroethylene inhalation studies of mice and rats which EPA is evaluating and expects to result in a B-2 classification of perc. (TR-311) | 127-18-4 |
| Final Rule | Hydroquinone | EPA final rule requiring testing under TSCA Section 4. December 20, 1985 -- 50 FR 53145 |
Carcinogenicity testing not required because NTP conducting 2-year bioassay. (TR-366) | 123-31-9 |
| Notice | Trichloroethylene | EPA notice of assessment of TCE as a potentially toxic air pollutant and intent to list under CAA Section 112. (This rule was clarified on 3/5/86.) December 23, 1985 -- 50 FR 52422 |
"The conclusion that TCE is a probable carcinogen is based on the findings of the NCI (1976) and NTP (1982) mouse studies..." (TR-243) | 79-01-6 |
| Notice | Perchloroethylene | EPA notice of assessment of perc as a potentially toxic air pollutant and intent to list under CAA Section 112. December 26, 1985 -- 50 FR 52880 |
NTP inhalation study, which showed a carcinogenic potential in male rats and both sexes of mice, "has resulted in this notice of intent to list." (TR-311) | 127-18-4 |
| Proposed Rule | Hydroquinone | EPA proposed rule on testing standards for hydroquinone. December 30, 1985 -- 50 FR 53160 |
NTP 2-year gavage study will provide data for comparison with dermal contact data from required toxicokinetic studies. (TR-366) | 123-31-9 |
| Notice | Formamide | EPA notice of decision not to require further testing under TSCA Section 4, pursuant to federal district court ruling that EPA, in lieu of a negotiated testing agreement, require testing or give reasons for not requiring testing. February 27, 1986 -- 51 FR 6929 |
NTP testing of formamide over 5 doses in 4 strains of salmonella; no indication of mutagenic activity seen. | 75-12-7 |
| Notice | Perchloroethylene | EPA correction of previous FR notice to assess perchloroethylene as a potentially toxic air pollutant under the Clean Air Act Section 112. March 5, 1986 -- 51 FR 7718 |
NTP toxicology and carcinogenesis studies in rats and mice. TR-311. | 127-18-4 |
| Proposed Rule | Pentachloroethane | EPA proposed rule promulgating a significant new use rule under TSCA Section 5. (Final rule published 9/9/86.) March 24, 1986 -- 51 FR 10024 |
NTP bioassay demonstrated evidence of carcinogenicity in both sexes of rats and mice. TR-232. | 76-01-7 |
| Final Rule | Cresols | EPA final rule to require testing under TSCA Section 4. April 28, 1986 -- 51 FR 15771 |
NTP is planning range-finding and subchronic studies. (TOX-09) | 1319-77-3 |
| Final Rule | Methylcyclopentane and Commercial Hexane | EPA proposed rule to require testing under TSCA Section 4. May 15, 1986 -- 51 FR 17854 |
NTP is conducting a subchronic inhalation toxicity test and is supporting reproductive and developmental toxicity testing. (TOX-02) | 110-54-3 96-37-7 |
| Proposed Rule | 8 Polybrominated Biphenyls (PBB's) and Tris | EPA proposed rule promulgating a significant new use rule under TSCA Section 5. July 7, 1986 -- 51 FR 24555 |
Reference to NTP bioassay of polybrominated biphenyl mixture. TR-244. | 67774-32-7 |
| Final Rule | Chlorinated Benzenes | EPA final rule to require testing under TSCA Section 4. July 8, 1986 -- 51 FR 24657 |
NTP studies of 1,2,4,5-TCB, 1,2-DCB, & 1,4-DCB. (TR-319) (TR-255) | 106-46-7 95-50-1 95-94-3 |
| Notice | Toluenediamines | EPA notice of termination of investigation of occupational exposure in light of evidence of carcinogenicity. July 10, 1986 -- 51 FR 25070 |
Bioassays conducted under the NTP have demonstrated that 2,4-Toluenediamine causes cancer in lab animals. (TR-162) | 95-80-7 |
| Proposed Rule | 11-Aminoundecanoic Acid | EPA proposed rule promulgating a significant new use rule under TSCA Section 5. July 22, 1986 -- 51 FR 26273 |
NTP carcinogenesis bioassay shows 11-AA induces malignant tumor response in male rats and also can cause non-oncogenic effects in lab animals. TR-216. | 2432-99-7 |
| Proposed Rule | 1,1-Dichloroethylene | EPA proposed rule to require testing under TSCA Section 4. August 12, 1986 -- 51 FR 28840 |
NTP's 2-year gavage study was the "only study considered by EPA to have an adequate protocol to demonstrate a chemical's lack of oncogenic potential," although this study may not have achieved a sufficiently high dose." TR-228 | 75-35-4 |
| Final Rule | 1,2-Dichloropropane | EPA final rule to require testing under TSCS Section 4. September 9, 1986 -- 51 FR 32079 |
NTP 2-year bioassay "is adequate to determine the oncogenic potential of DCP." Also notes NTP concern over DCP in drinking water as indicating need for oral exposure in testing. TR-263. | 78-87-5 |
| Final Rule | Pentachloroethane | EPA final rule promulgating a significant new use rule under TSCA Section 5. September 9, 1986 -- 51 FR 32077 |
NTP bioassay demonstrated limited evidence of carcinogenicity in lab animals. TR-232. | 76-01-7 |
| Other | Dioxin-containing wastes | EPA denial of petition to amend rule listing certain dioxin-containing wastes as acute hazardous wastes. September 15, 1986 -- 51 FR 32670 |
NTP bioassay study of HXCDD referred to in docket. TR-198. | 57653-85-7 |
| Final Rule | Bisphenol A | EPA final rule to require a 90-day inhalation subchronic toxicity study with particular emphasis on pulmonary effects, under TSCA Section 4. September 18, 1986 -- 51 FR 33047 |
NTP oral gavage bioassay provides needed data to evaluate subchronic toxicity of PBA. TR-215. | 80-05-7 |
| Other | Guidelines for Assessing Health Risks of Environmental Pollutants | EPA issuance of guidelines for carcinogen risk assessment, mutagenicity risk assessment, health risk assessment of chemical mixtures, and health assessment of suspect developmental toxicants. September 24, 1986 -- 51 FR 33992 |
Each of these 4 EPA guidelines makes reference to NTP studies. | N/A |
| Notice | Nickel Subsulfide and Nickel Carbonyl | EPA notice of determination that no Federal regulation is warranted at this time under CAA. September 25, 1986 -- 51 FR 34135 |
NTP and NIEHS are ;currently conducting animal bioassays of selected nickel compounds.; (TR-454) (TR-451) (TR-453) | 10101-97-0 1313-99-1 12035-72-2 |
| Notice | 1,3-Dichloropropene | EPA notice of special review of pesticides containing 1,3-dichloropropene. October 8, 1986 -- 51 FR 36160 |
NTP gavage study showed clear evidence of carcinogenicity. TR-269. | 542-75-6 |
| Final Rule | 2-Ethylhexanoic Acid | EPA final rule to require testing under TSCA Section 4. November 6, 1986 -- 51 FR 40318 |
Reference to NTP nomination of compounds containing the 2-ethylhexyl moiety for mutagenicity testing. | 149-57-5 |
| Proposed Rule | 2-Ethylhexanol | EPA proposed rule on testing under TSCA Section 4. December 19, 1986 -- 51 FR 45487 |
Reference to study of 2-Ethyl-1-hexanol supported by NIEHS. | 104-76-7 |
| Notice | Pentachlorophenol | EPA notice of decision to cancel registrations for all products containing pentachlorophenol for all non-wood uses except pulp/paper mill, oil well operations, and cooling tower uses. January 21, 1987 -- 52 FR 2282 |
EPA requested that NTP reexamine female rat liver lesions from NCI study. | 87-86-5 |
| Final Rule | 8 Polybrominated Biphenyls (PBB's) and Tris | EPA final rule promulgating a significant new use rule under TSCA Section 5. January 26, 1987 -- 52 FR 2699 |
Reference to NTP bioassay of polybrominated biphenyl mixture. TR-244. | 67774-32-7 |
| Proposed Rule | P-Dichlorobenzene | EPA proposed rule to regulate p-dichlorobenzene as a probable human carcinogen under the Safe Drinking Water Act by amending the Maximum Contaminant Level Goal (MCLG). April 17, 1987 -- 52 FR 12876 |
Based upon the results of the above studies and specifically the conclusions of the NTP report (bioassay of p-dichlorobenzene), EPA is proposing to amend the MCLG. TR-319. | 106-46-7 |
| Notice | 2,4,5-Trichlorophenol | EPA notice of intent to cancel registration as active ingredient for all uses. April 29, 1987 -- 52 FR 15549 |
References to several NTP studies of 2,3,7,8-TCDD, a contaminant of 2,4,5-TCP. (TR-209) | 1746-01-6 |
| Proposed Rule | Cyclohexane | EPA proposed rule on test standards and requirements under TSCA Section 4. May 20, 1987 -- 52 FR 19096 |
Reference to study of cyclohexane supported by NIEHS. | 110-82-7 |
| Final Rule | 11-Aminoundecanoic Acid | EPA final rule promulgating a significant new use rule under TSCA Section 5. May 28, 1987 -- 52 FR 19860 |
NTP bioassay showed limited evidence of carcinogenicity in animals. (TR-216) | 2432-99-7 |
| Final Rule | Polyhalogenated Dibenzo-p-dioxins and Dibenzofurans (HDD and HDF) | EPA final rule under TSCA to require testing for certain chemicals for HDD/HDF contamination. June 5, 1987 -- 52 FR 21412 |
Decabromodiphenyl Oxide, in grade used in NTP research, is exempt from this rule because NTP studies showed equivocal evidence of carcinogenicity in male mice and no evidence in female mice. (TR-309) | 1163-19-5 |
| Final Rule | Fluoroalkenes | EPA final rule to require testing under TSCA Section 4. June 8, 1987 -- 52 FR 21516 |
NTP subchronic inhalation study of vinylidene fluoride. | 75-38-7 |
| Final Rule | 8 Volatile Synthetic Organic Chemicals (VOC's) | EPA final rule for National Primary Drinking Water Regulations setting maximum contaminant levels and monitoring requirements for 8 VOC's under the Safe Drinking Water Act (SDWA). July 8, 1987 -- 52 FR 25690 |
NTP chronic bioassay of rats and mice showed clear evidence of carcinogenicity of para-dichlorobenzene, TR-319. | 106-46-7 |
| Notice | Drinking Water | EPA notice of 7 substituted contaminants on SDWA list of 83 contaminants. July 8, 1987 -- 52 FR 25720 |
Dibromomethane (proposed for removal from list) is being considered for NTP testing. Ethylbenzene (proposed for addition to list) is being tested by NTP. | 100-41-4 106-93-4 |
| Final Rule | 1,2,4,5-Tetrachlorobenzene | EPA final rule modifying the test substance purity requirements under TSCA Section 4. July 15, 1987 -- 52 FR 26477 |
NTP-identified test material having 99+% purity not available to manufacturers. | 95-94-3 |
| Notice | Ethylene Bisdithiocarbamate (EBDC) | EPA notice of initiation of special review to determine whether regulatory action is required. July 17, 1987 -- 52 FR 27172 |
NTP is currently conducting an oncogenicity study of ETU, a common contaminant, degradation product, and metabolite of EBDC. (TR-388) | 96-45-7 |
| Proposed Rule | Butyl Benzyl Phthalate | EPA proposed rule to delete this chemical from SARA Section 313 list of chemicals for which release reporting is required. July 20, 1987 -- 52 FR 27226 |
NTP bioassay results constitute equivocal evidence of carcinogenicity. (TR-213) | 85-68-7 |
| Final Rule | 2-Ethylhexanol | EPA final rule to require a 2-year oncogenicity bioassay under TSCA Section 4. August 3, 1987 -- 52 FR 28698 |
Reference to studies of 2-Ethylhexanol supported by NIEHS. | 104-76-7 |
| Notice | CPSC statement of enforcement policy for household products containing methylene chloride. September 14, 1987 -- 52 FR 34698 |
NTP inhalation bioassay showed clear evidence of carcinogenicity in female rats and male and female mice. (TR-306) | 75-09-2 | |
| Final Rule | Polyamine-epichlorohydrin | FDA final rule amending food additive regulations concerning paper and paperboard components. December 10, 1987 -- 52 FR 46744 |
Reference to NCI/NTP bioassay of 1,2-dichloroethane. (TR-055) | 107-06-2 |
| Final Rule | Commercial Hexane | EPA final rule to require testing under TSCA Section 4. February 5, 1988 -- 53 FR 3382 |
Description of NTP dosing regimen in discussion of subchronic test standards. | 110-54-3 |
| Notice | Dichlorvos | EPA notice of initiation of special review of determine whether registration should be cancelled or otherwise amended in light of carcinogenic and other health effects. February 24, 1988 -- 53 FR 5542 |
"Based on the NTP oncogenicity studies and chronic toxicity studies, in conjunction with exposure assessments of dietary, worker, residential, and pet risks, EPA has determined that all uses of dichlorvos have met the criterion for initiation of Special Review.." (TR-342) | 62-73-7 |
| Final Rule | Diethylene Glycol Butyl Ether and Diethylene Glycol Butyl Ether Acetate | EPA final rule to require testing under TSCA Section 4. February 26, 1988 -- 53 FR 5932 |
NTP currently is conducting an oncogenicity study of structurally similar glycol ethers. | 112-34-5 |
| Proposed Rule | Isopropanol | EPA proposed rule to require testing under TSCA Section 4. March 16, 1988 -- 53 FR 8638 |
"The only adequate study" of mutagenicity is a salmonella reverse mutation assay conducted by NTP. | 67-63-0 |
| Notice | Naphthalene | EPA notice of assessment results under Clean Air Act, concluding that the health data base is insufficient to warrant regulation under the CAA. March 21, 1988 -- 53 FR 9138 |
NTP 2-year inhalation study is currently in progress. (TR-410) | 91-20-3 |
| Notice | RCRA Hazardous Waste Identification | EPA notice regarding strategy for setting compound-specific dilution/attenuation factors in the Toxicity Characteristic used by waste generators to determine whether their solid wastes are hazardous. May 19, 1988 -- 53 FR 18024 |
NTP studies of 1,4-dichlorobenzene, Pyridine, and Methylene Chloride (TR-306) (TR-319) (TR-283) | 75-09-2 106-46-7 110-86-1 |
| Proposed Rule | Melamine | EPA proposed rule to delete melamine from list of toxic chemicals for which toxic chemical release reporting is required under SARA Section 313. June 20, 1988 -- 53 FR 23128 |
NTP bioassay resulted in statistically significant increase in carcinomas in male rats. (TR-245) | 108-78-1 |
| Proposed Rule | Benzene | EPA proposed rule on setting NESHAP applicable to benzene equipment leaks, ethylbenzene/styrene and maleic anhydride process vents, benzene storage vessels, and coke byproduct recovery plants. July 28, 1988 -- 53 FR 28496 |
NTP 2-year chronic study of mice and rats orally exposed found significant incidence of cancers at multiple sites in both sexes and both species. (TR-289) | 71-43-2 |
| Notice | Certain Chemicals in Anilines Category | EPA notice of termination of rulemaking because there is no basis for finding of unreasonable risk of injury to health or the environment. August 19, 1988 -- 53 FR 31814 |
Reference to study of 4-chloro-2-nitroaniline supported by NIEHS. | 89-63-4 |
| Final Rule | Aniline & 7 Substituted Anilines | EPA final rule regarding enforceable testing consent orders under TSCA. August 19, 1988 -- 53 FR 31804 |
References to studies of p-chloroaniline and 4-nitroaniline supported by NIEHS. | 106-47-8 100-01-6 20265-96-7 |
| Final Rule | 2-Mercaptobenzothiazole | EPA final rule to require testing under TSCA Section 4. September 7, 1988 -- 54 FR 34514 |
NTP chronic and subchronic studies of MBT. (TR-332) | 149-30-4 |
| Proposed Rule | Methyl Ethyl Ketoxime | EPA proposed rule to require testing under TSCA Section 4. September 15, 1988 -- 53 FR 35838 |
Reference to NTP study of methyl ethyl ketone. | 78-93-3 |
| Proposed Rule | Hazardous Waste Management System | EPA proposed rule to amend RCRA regulations to list as hazardous 4 additional wastes from wood preserving and surface protection processes. December 30, 1988 -- 53 FR 53282 |
Reference to NTP study demonstrating carcinogenicity of pentachlorophenol. (TR-349) | 87-86-5 |
| Notice | Captan | EPA notice of intent to cancel registrations. February 24, 1989 -- 54 FR 8116 |
Rationale for combining organ sites and tumor sites in categorizing captan as a probable human carcinogen was based on NTP list of acceptable organ combinations. (TR-015) | 133-06-2 |
| Final Rule | Glycol Ethers | EPA final rule on enforceable testing consent order. April 4, 1989 -- 54 FR 13470 |
References to NTP studies of ethylene glycol monomethyl ether, 2-ethoxyethanol, and ethylene glycol monobutyl ether. | 109-86-4 110-80-5 111-76-2 |
| Proposed Rule | Dinitrobenzenes, Allyl Alcohol, Diethylamine, 2,3-Dichloropropene, Isosafrole, Creosote, Dinitrotoluene, Toluenediisocyanate | EPA proposed rule to add these chemicals to list of chemicals for which release reporting is required under SARA Section 313. April 21, 1989 -- 54 FR 16138 |
NTP Annual Report on Carcinogens is one of the 4 data sources used by EPA in making carcinogenic evaluations of Section 313 determinations. | 121-14-2 26471-62-5 109-89-7 8021-39-4 |
| Proposed Rule | Copper Phthalocyanine Pigments | EPA proposed rule to exempt Pigments Blue 15, Green 7, and Green 36 from SARA 313 release reporting requirements. May 15, 1989 -- 54 FR 20866 |
NTP oral studies of PB-15 and PG-7 showed no signs of compound-related toxicity. | 147-14-8 1328-53-6 |
| Proposed Rule | Drinking Water | EPA proposed rule on maximum contaminant level goals and National Primary Drinking Water Regulations for 30 synthetic organic chemicals and 8 inorganic chemicals. June 23, 1989 -- 54 FR 22062 |
NTP bioassays of chrysotile asbestos, 1,2-dichloropropane, monochlorobenzene, pentachlorophenol,styrene, tetrachloroethylene, and xylenes are cited. (TR-327) (TR-263) (TR-185) (TR-311) (TR-349) (TR-261) (TR-295) | 78-87-5 100-42-5 87-86-5 108-90-7 12001-29-5 127-18-4 1330-20-7 |
| Final Rule | Reportable quantities: Methyl Isocyanate (624-83-9), Aluminum Thiosulfate, and 258 other substances | EPA final rule retaining statutory RQ for MIC, delisting ammonium thiosulfate, and adjusting the RQ's of 258 hazardous substances. July 12, 1989 -- 54 FR 33426 |
Use of NTP report on carcinogens used as an initial screen for substances to be evaluated for potential carcinogenicity. MIC studies documented in EHP volume 72 utilized in decision to retain MIC. | 624-83-9 |
| Final Rule | Asbestos | EPA final rule under TSCA 6 to prohibit future manufacture, importation, processing, and distribution in commerce of asbestos in almost all products. July 12, 1989 -- 54 FR 29460 |
Reference to NTP toxicology and carcinogenesis studies of chrysotile asbestos. (TR-246) (TR-295) | 12001-29-5 |
| Final Rule | Reportable Quantities: 1,4-dioxane, 2-ethoxyethanol, ethylene oxide, 2-nitropropane, perchloroethylene, and saccharin. | EPA final rule adjusting the reportable quantities (RQ) of these six substances; hazardous substance releases in quantities equal to or greater than their RQ's must be reported to the National Response Center. August 14, 1989 -- 54 FR 33418 |
"The NTP annual reports (on carcinogens) and IARC monographs are used only as an initial screen for substances to be evaluated for potential carcinogenicity by the Agency. EPA follows the procedures set out in its Guidelines for Carcinogen Risk Assessment to make this determination." | 75-21-8 110-80-5 79-46-9 123-91-1 81-07-2 |
| Final Rule | Methyl Ethyl Ketoxime (96-29-7) | EPA final rule under TSCA 4 to require testing for oncogenicity, mutagenicity, developmental toxicity, reproductive toxicity, neurotoxicity, and pharmacokinetics. September 13, 1989 -- 54 FR 37799 |
Reference to NTP research on MEKA and other NTP studies relevant to the testing requirements. | 96-29-7 |
| Notice | Inert Ingredients in Pesticides | EPA notice for revision of lists of inert ingredients of toxicological concern. November 22, 1989 -- 54 FR 48314 |
Based on an NTP bioassay di-(2-ethylhexyl)adipate was moved to List 1 ("Inerts of Toxicological Concern") from List 3 ("Inerts of Unknown Toxicity") (TR-212) | 103-23-1 |
| Notice | Ethylene Bisdthiocarbamate (EBDC) Pesticides | EPA Notice of Preliminary Determination to propose cancellation of certain registrations of EBDC products and propose modifications of registrations not cancelled. December 20, 1989 -- 54 FR 52158 |
NTP carcinogenicity studies of ethylene thiourea (ETU) (CAS: 96-45-7), a common contaminant, metabolite, and degradation product of EBDCs. (TR-388) | 96-45-7 |
| Other | National Primary and Secondary Drinking Water Regulations; Fluoride | EPA is soliciting information that has a bearing on the current standards for fluoride in drinking water. January 3, 1990 -- 55 FR 160 |
EPA notes that the NTP is in the process of completing a two-year bioassay on fluoride which may provide additional insights. (TR-393) | 7681-49-4 |
| Other | Chrome Antimony Titanium Buff Rutile; Toxic Chemical Release Reporting; Community Right-to-Know | EPA is denying a petition to exempt Chrome Antimony Titanium Buff Rutile from reporting under the Emergency Planning and Community Right-to-Know Act of 1986 (EPCRA) January 8, 1990 -- 55 FR 650 |
Based on the 4th Annual Report on Carcinogens, the NTP considers all chromium compounds to be potential carcinogens. | N/A |
| Final Rule | National Primary and Secondary Drinking Water Regulations; Synthetic Organic Chemicals and InorganicChemicals | EPA is proposing maximum contaminant level goals and National Primary Drinking Water Regulations for organic and inorganic chemicals. July 25, 1990 -- 55 FR 30370 |
The EPA used data from the following NTP studies: di(ethylhexyl)adipate, dichloromethane, hexachlorocyclopentadiene, di(2-ethylhexl)phthalate, butylbenzyl phthalate,and tetrachlorodibenzo-p-dioxin. (TR-306) (TR-201) (TR-209) (TR-217) (TR-213) (TR-212) | 75-09-2 77-47-4 1746-01-6 117-81-7 85-68-7 103-23-1 |
| Proposed Rule | Pesticide Tolerances for Oxytetracycline | This document proposes that tolerances be established for residues of the pesticide oxytetracycline in or on the raw agricultural commodities cherries and tomatoes. August 1, 1990 -- 55 FR 31194 |
Data from the NTP oncogenicity study in rats fed oxytetracycline was used in support of the proposed tolerances. (TR-315) | 2058-46-0 |
| Final Rule | Identification and Listing of Hazardous Waste; Wood Preserving | The EPA is amending its regulations under the Resource Conservation and Recovery Act by listing as hazardous three categories of wastes from wood preserving operations. December 6, 1990 -- 55 FR 50450 |
Data from the NTP bioassay on commercial grade pentachlorophenol was used for designating pentachlorophenol as a Class B sub 2 carcinogen. TR-349 | 87-86-5 |
| Proposed Rule | Aryl Phosphate Base Stocks; Proposed Test Rule Including Reporting and Record-keeping Requirements | EPA proposes that manufacturers, importers and processors of chemical substances in the category of aryl phosphate base stocks be required, under section 4 of the Toxic Substances Control Act to conduct testing. January 17, 1992 -- 57 FR 2138 |
Reproductive toxicity was demonstrated in the continuous breeding protocol in Swiss mice (1988). The EPA will examine the results of the NTP 2-year bioassay on TCP before deciding whether further oncogenicity testing on any other aryl phosphate is needed. (TR-433) | 1330-78-5 |
| Notice | Ethylene Bisdithiocarbamates: Notice of Intent to Cancel; Conclusion of Special Review | The EPA concludes the Special Review and risk/benefit analysis of EBDCs and announces the intent to cancel registrations and to deny applications for registration for all pesticide products containing EBDCs as an active ingredient unless the registrations/applications comply with the terms and conditions of registration set forth in this Notice. The Agency has determined that use will result in unreasonable adverse effects to humans or the environment. March 2, 1992 -- 57 FR 7484 |
Data from the NTP bioassay on ethylene thiourea (ETU) were used by the EPA (TR-388) | 96-45-7 |
| Notice | Draft Report: A Cross-Species Scaling Factor for Carcinogen Risk Assessment Based on Equivalence of mg/kg 3/4/day | The EPA, FDA, and CPSC are asking for public comments on a draft report: A Cross-Species Scaling Factor for Carcinogen Risk Assessment Based on Equivalence of mg/kg/3/4/day. June 5, 1992 -- 57 FR 24152 |
Data from NCI/NTP bioassays were used to develop the report. | N/A |
| Notice | Thirtieth Report of the Interagency Testing Committee: Request for Comments Regarding Priority Testing List of Chemicals | The Priority Testing List was revised by adding one chemical group, the siloxanes, and four chloralkyl phosphates. July 9, 1992 -- 57 FR 30608 |
At the request of the NTP, TSCA Section 8(d) reports on health effects of bis-(4-chlorophenyl) sulfone were provided to facilitate NTP's evaluation of this chemical. | 80-07-9 |
| Final Rule | Drinking Water: National Primary Drinking Water Regulations-Synthetic Organic Chemicals and Inorganic Chemicals; National Primary Drinking Water Regulations Implementation | EPA is promulgating maximum contaminant level goals and National Primary Drinking Water Regulations for 18 synthetic organic and 5 inorganic chemicals. July 17, 1992 -- 57 FR 31776 |
The MCLG for Di(2-ethylhexyl)adipate was derived from the NTP 2-year dietary study, TR-212. The classification of DEHP as a Group B2 (probable human) carcinogen was based on the NTP 2-year study, (TR-217) | 117-81-7 103-23-1 |
| Final Rule | Chemicals: Toxic Chemical Release Reporting; Community Right-To-Know; Proposed Significant New Use Rule | The EPA is partially granting a petition submitted by the Governor of New York to add 80 chemicals and 2 chemical categories to the list of toxic chemicals subject to reporting under section 313 of the Emergency Planning and Community Right-To-Know Act by proposing to add 68 chemicals and 2 chemical categories. September 8, 1992 -- 57 FR 41020 |
The EPA used several NTP bioassays as sources of information. (TOX-18) (TR-403) (TR-314) (TR-237) (TR-039) (TR-00A) | 1338-23-4 108-46-3 80-62-6 630-20-6 303-34-4 148-82-3 |
| Final Decision | National Ambient Air Quality Standards For Ozone. | Announcement that revisions of the national ambient air quality standards for ozone are not appropriate at this time. March 9, 1993 -- 58 FR 13008 |
Substantial new information has been published since the last criteria document. The NTP toxicology and carcinogenesis study on ozone (TR-440) to be peer-reviewed 11/93 was cited as an example of a study which may yield significant new information. | 10028-15-6 |
| Final Rule | Pesticide Tolerance and Animal Feed Additive Regulation for Fluoride Compounds | Establishment of a 3-year time-limited tolerance for residues of cryolite and/or synthetic cryolite. May 5, 1993 -- 58 FR 26687 |
Data from the NTP toxicology and carcinogenesis study of sodium fluoride (TR-393) was considered in support of the tolerances. | 7681-49-4 |
| Proposed Rule | C.I. Pigment Violet #23 (Carbazole Violet), C.I. Pigment Blue #15, C.I. Pigment Green #7, and FD & C Red No. 40; Tolerance Exemptions | Exemption from the requirement of a tolerance be established for residues of C.I. Pigment Violet #23, C.I. Pigment Blue #15, C.I. Pigment Green #7 and FD Red No. 40 when used as inert ingredients in pesticide formulations applied to growing crops only. June 30, 1993 -- 58 FR 34973 |
NTP data used to support the proposed tolerance exemptions for C.I. Pigment Blue #15 and C.I. Pigment Green #7. The NTP decided not to perform toxicology and carcinogenesis studies of C.I. Pigment Green #7 and C.I. Pigment Blue #15 based on the lack of absorption or adverse effects in a 90-day feed study in rats and mice. | 147-14-8 1328-53-6 |
| Final Rule | Revocation of Food Additive Regulations for Benomyl, Mancozeb, Phosmet, and Trifluralin | Revocation of certain food additive regulations for four pesticides, benomyl, mancozeb, phosmet, and trifluralin, which were included in a 1989 petition. July 14, 1993 -- 58 FR 37862 |
Ethylene thiourea (ETU), a major contaminant, metabolite and breakdown product of mancozeb has been shown in the NTP toxicology and carcinogenesis study (TR-388) to induce cancer in animals. | 96-45-7 |
| Proposed Rule | Pesticide Tolerance for Dimethoate | Establishment of a tolerance for residues of the insecticide dimethoate in or on raw Brussels sprouts. September 1, 1993 -- 58 FR 46147 |
NTP concluded that dimethoate is a mutagenic compound based on its testing for gene mutation and chromosomal aberrations. | 60-51-5 |
| Final Rule | Dichlorvos: Revocation of Food Additive Tolerance | Revocation of the food additive regulation for residues of the pesticide dichlorvos in or on packaged or bagged non perishable processed food. November 10, 1993 -- 58 FR 59663 |
Data from the NTP toxicology and carcinogenesis study of dichlorvos (TR-342) in F344 rats showing statistically significant increases in leukemia in males at 2 dose levels was used. | 62-73-7 |
| Final Rule | Acetophenone, Phenol, N,N-Dimethylaniline, Ethyl Acetate, and 2,6-Dimethylphenol; Proposed Test Rule, Notice of Opportunity to Initiate Negotiations for TSCA Section 4 Testing Consent Agreements | Proposed Rule: Proposed test rule under section 4(a) of the Toxic Substances Control Act (TSCA) that would require manufacturers and processors of five chemicals, acetophenone, phenol, n, n-dimethylaniline, ethyl acetate, and 2,6-dimethylphenol, to conduct testing for certain chemical fate, health and environmental effects. November 22, 1993 -- 58 FR 61654 |
The proposed rule reflects EPA's current thinking in the area of mutagenicity testing, both as an endpoint and as it leads to oncogenicity testing. This new information is partially based on data from the NTP's study of the ability of short-term tests to predict carcinogenic potential. For phenol, no additional testing for developmental effects is being proposed because NTP studies are adequate for this endpoint. For N,N-dimethylaniline, the NTP toxicology and carcinogenesis study (TR-360) identified the rat as more sensitive than the mouse to the noncarcinogenic effects on erythrocytes and spleen. | 121-69-7 |
| Proposed Rule | Significant New Uses of Certain Acrylate Esters | Proposed a significant new use rule (SNUR) under section 5(a)(2) of the Toxic Substances Control Act for all acrylate esters falling within the definition proposed in this rule (acrylate substances). November 22, 1993 -- 58 FR 61649 |
The EPA has concluded certain acrylates may present a risk of cancer. This conclusion is based primarily upon data available for a subset of acrylates which have demonstrated positive results. The NTP toxicology and carcinogenesis study of ethyl acrylate (TR-259) used to support conclusion. | 140-88-5 |
| Final Rule | Pesticide Tolerances for Dicamba | Establishment of a tolerance for the combined residues of the herbicide dicamba and its 5-hydroxy metabolite. November 24, 1993 -- 58 FR 62039 |
Negative results of NTP toxicology and carcinogenesis study of dichlorodibenzo-p-dioxin (TR-123) cited. The Agency has concluded that there is no potential carcinogenic risk to humans from a DCDD impurity in the dicamba to be used on cotton. | 33857-26-0 |
| Final Rule | Chemicals; Toxic Chemical Release Reporting; Community Right-to-Know; Significant New Use Rule | Final Rule: Addition of 21 chemicals and 2 chemical categories to the list of toxic chemicals under section 313 of the Emergency Planning and Community Right-to-Know Act of 1986 (EPCRA). December 1, 1993 -- 58 FR 63500 |
NTP toxicity study of formic acid (TOX-19) demonstrated sufficient evidence to establish that formic acid can reasonably be anticipated to cause in humans chronic health effects as described in EPCRA section 313(d)(2)(B). | 64-18-6 |
| Notice | Drinking Water Maximum Contaminant Level Goal; Fluoride | Announcement of decision not to revise the maximum contaminant level goal (MCLG) for fluoride after consideration of recent reports concerning the health effects of fluoride. December 29, 1993 -- 58 FR 68826 |
NTP toxicology and carcinogenesis study of fluoride (TR-393) cited. Study concluded that there was equivocal evidence in male F344/N rats, and no evidence in female F344/N rats or male or female mice. | 7681-49-4 |
| Final Rule | Addition of Certain Chemicals; Toxic Chemical Release Reporting; Community Right-to-Know | Addition of 313 chemicals and chemical categories to the list of toxic chemicals required to be reported on under section 313 of the Emergency Planning and Community Right-to-Know Act of 1986 and section 6607 of the Pollution Prevention Act of 1990. January 12, 1994 -- 59 FR 1788 |
EPA considered chemicals designated as possible, probable, or known carcinogens in the Monographs of IARC and the 6th Annual Report on Carcinogens published by the NTP. Also, used results of the NTP toxicology and carcinogenesis studies of C.I. Acid Red 114 (TR-405), C.I. Direct Blue 218 (TR-430), Chlorendic acid (TR-304), 3-Chloro-2-methyl-1-propene (TR-300), Diglycidyl resorcinol ether, (TR-257), 3,3-Dimethoxybenzidine dihydrochloride (TR-372), 3,3-Dimethylbenzidine dihydrochloride (TR-390), and 5,5-Diphenylhydantoin (phenytoin) (TR-404). | 115-28-6 57-41-0 28407-37-6 6459-94-5 101-90-6 563-47-3 20325-40-0 612-82-8 |
| Final Rule | Cold, Cough, Allergy, Bronchodilator, and Antiasthmatic Drug Products for Over-the Counter Human Use; Amendment of Final Monograph of OTC Antihistamine Drug Products | Establishment of conditions under which over-the-counter antihistamine drug products are generally recognized as safe and effective and not misbranded. Dec. 9, 1992. Amendment of final rule to include doxylamine succinate. January 28, 1994 -- 59 FR 4216 |
Data from the NTP toxicology and carcinogenesis study on pyrilamine (TRs 408, 409) was used to determine that pyrilamine maleate is safe for OTC use. The results of an NCTR-toxicology and carcinogenesis study of doxylamine succinate conducted under the auspices of the NTP were used in developing a talk paper concerning the NCTR-findings in animals to inform consumers of these data and the uncertainty of their relevance to humans. | 469-21-6 91-84-9 |
| Proposed Rule | d_Limonene; Tolerance Exemption | Exemption from the requirement of a tolerance be established for residues of d-limonene when used as an inert ingredient in pesticide formulations applied to growing crops or raw agricultural commodities after harvest. February 23, 1994 -- 59 FR 8581 |
The NTP toxicology and carcinogenesis study of d-Limonene showed no carcinogenic activity in female rats and mice and in male mice. Clear evidence of kidney-associated carcinogenic activity was noted in male rats. However, the NTP concluded that the male rat kidney carcinogenicity is not predictive of mammalian carcinogenicity. (TR-347) | 5989-27-5 |
| Final Rule | Dicofol; Revocation of Food Additive Tolerance | Revocation of the food addditive tolerance for residues of the pesticide dicofol in or on dried tea. March 9, 1994 -- 59 FR 10993 |
Data from the NTP toxicology and carcinogenesis study of dicofol (TR-90) showed a statistically significant increase of hepatocellular adenomas and combined hepatocellular adenomas and carcinomas in male mice (B6C3F1) at two doses tested. |
115-32-2 |
| Final Rule | Fuels and Fuel Additives Registration Regulations | Establishment of new requirements for the registration of designated fuels and fuel additives as authorized by sections of the Clean Air Act. June 27, 1994 -- 59 FR 33042 |
NTP 13-week inhalation study of N-Hexane in B6C3F1 mice is cited as a reference for the neuropathology assessment. (TOX-02) | 110-54-3 |
| Proposed Rule | Pesticides; Proposed Rule Revoking Certain Food Regulations | Revocation of certain food additive regulations for several pesticides which EPA has determined "induce cancer" within the meaning of the Delaney Clause of section 409 of the Federal Food, Drug and Cosmetic Act. July 1, 1994 -- 59 FR 33941 |
NTP toxicology and carcinogenesis study of ethylene oxide (TR-326) is cited as one of the studies used for conclusions that ethylene oxide induces cancer in animals. | 75-21-8 |
| Notice | Thirty-Fourth Report of the TSCA Interagency Testing Committee to the Administrator: Receipt of Report and Request for Comments | Receipt of report of the TSCA Interagency Testing Committee to the Administrator. The ITC revised the Priority Testing List including the removal of eight chemicals from the List. July 13, 1994 -- 59 FR 35720 |
The negative results of the NTP toxicology and carcinogenesis study of the structurally-related N-phenyl-2-napththylamine (TR-333) was used by the ITC in developing its rationale for removing N-phenyl-1-napththylamine from the List. | 135-88-6 |
| Proposed Rule | Drinking Water; National Primary Drinking Water Regulations: Disinfectants and Disinfection Byproducts | Includes establishment of maximum residual disinfectant level goals (MRDLGs) for chlorine, chloramines, and chlorine dioxide and maximum contaminant level goals (MCLGs) for bromodichloromethane, dibromochloromethane, and bromoform. July 29, 1994 -- 59 FR 38668 |
Data from the NTP toxicology and carcinogenesis studies of bromodichloromethane (TR-321), chlorinated and chloraminated water (TR-392), bromoform (TR-350), and dibromochloromethane (TR-282) were used as part of the evaluation to set maximum residual disinfectant level goals for these substances. | 75-25-2 75-27-4 124-48-1 CHLORWATERMX |
| Proposed Rule | Asbestos Worker Protection; Asbestos-Containing Materials in Schools; Proposed Amendment | The proposed rule would generally extend the coverage provided under the 1986 OSHA Asbestos Standard for Construction to State and local government employees who are not covered by OSHA- or EPA-approved State plans. It also proposes to extend coverage provided under the OSHA Asbestos Standard for General Industry for automotive brake and clutch repair. November 1, 1994 -- 59 FR 54746 |
The EPA classifies asbestos as a Group A carcinogen as cited in the NTP's 7th Annual Report on Carcinogens. (TR-280) (TR-279) (TR-277) (TR-295) | 12001-28-4 12172-73-5 14567-73-8 12001-29-5 |
| Final Rule | Addition of Certain Chemicals; Toxic Chemical Release Reporting; Community Right-to-Know | EPA is taking this action pursuant to its authority to add to the list those chemicals and chemical categories that meet the EPCRA section 313(d)(2) criteria for addition to the list of toxic chemicals. November 30, 1994 -- 59 FR 61432 |
Long-chain chlorinated paraffins have not been classified as "probable human carcinogens" by NTP or IARC and the NTP bioassay (TR-305) showed insufficient evidence. Therefore the EPA concludes that there is insufficient evidence to list long-chain chlorinated paraffins on the EPCRA section 313 list. | 108171-27-3 |
| Proposed Rule | Acephate, Triadimefon, Iprodione, and Imazalil; Revocation of Food Additive Regulations | EPA is proposing to revoke food additive regulations for five pesticides which EPA has determined "induce cancer" within the meaning of the Delaney clause of section 409 of the Federal Food, Drug and Cosmetic Act (FFDCA). After a full evaluation of all the data and supporting information regarding animal carcinogenicity, the EPA has concluded that exposure to triadimefon results in the induction of hepatocellular adenomas in NMRI mice. Hepatocellular adenomas are considered to be evidence of cancer because hepatocellular adenomas can progress to hepatocellular carcinomas. January 18, 1995 -- 60 FR 3607 |
EPA supports its conclusion that hepatocellular adenomas can progress to hepatocellular carcinomas with NTP's rationale for combining tumor types for an overall analysis of carcinogenicity (in addition to analyzing them separately). | N/A |
| Final Rule | Food and Feed Additive Regulations for d-Limonene, Dihydro-5-Pentyl-2(3H)-Furanone, and Dihydro-5-Heptyl-2(3H)-Furanone | EPA proposes to establish food/feed additive regulations for residues of the insecticide d-limonene when used as an active ingredient in insect-repellent tablecloths and in insect repellent strips used in food/feed-handling establishments. February 8, 1995 -- 60 FR 7511 |
Data on the oral toxicity of d-limonene was summarized in the NTP 2-year bioassay and comprehensive literature review. TR-347 | 5989-27-5 |
| Proposed Rule | Test Rule; Office of Water Chemicals Proposed Withdrawal of Certain Testing Requirements | The EPA is proposing to withdraw certain testing requirements for two chemical substances listed in the Office of Water chemicals test rule. This proposal includes the withdrawal of the 90-day subchronic testing requirements for 1,1,2,2-tetrachloroethane. April 10, 1995 -- 60 FR 18079 |
The NTP's 90-day subchronic toxicity drinking water study of 1,1,2,2-tetrachloroethane meets the 90-day subchronic toxicity test required under the test rule and can be used to establish long-term Health Advisories for the Office of Water. (TOX-45) | 79-34-5 |
| Other | Monosodium Methanearsonate and Disodium Methanearsonate: Toxic Chemical Release Reporting; Community Right-to-Know | EPA is denying a petition to delist monosodium methanearsonate and disodium methanearsonate from the reporting requirements under section 313 of the Emergency Planning and Community Right-to-Know Act of 1986. April 20, 1995 -- 60 FR 19702 |
The EPA and the NTP have classified inorganic arsenicals, including arsenate, as known human carcinogens. (NTP 7th Annual Report on Carcinogens) | N/A |
| Final Rule | Diflubenzuron: Pesticide Tolerances | The EPA established tolerances for residues of the insecticide diflubenzuron in or on raw agricultural commodities. Para-chloroaniline (PCA) is a metabolite of diflubenzuron. May 10, 1995 -- 60 FR 24785 |
Information from the NTP bioassay on PCA was used to help establish maximum permissible levels (TR-351). | 20265-96-7 |
| Final Rule | Reportable Quantity Adjustments | The EPA has taken final action on reportable quantities (RQs) for hazardous substances under the Comprehensive Environmental Response, Compensation, and Liability Act. The person in charge of a facility or vessel from which a hazardous substance is released in excess of its RQs must notify appropriate authorities, who can then evaluate whether a response is needed. June 12, 1995 -- 60 FR 30926 |
The Agency has promulgated a final RQ of 100 pounds (as proposed) based on chronic toxicity. Because no chronic toxicity studies have been reported for diethanolamine, both EPA and commenters used data from a NTP 13-week subchronic study (TOX-20) to develop their respective conclusions. | 111-42-2 |
| Proposed Rule | Food Additives Permitted for Direct Addition to Food for Human Consumption; Acesulfame Potassium | The EPA proposes to establish a tolerance for residues of the insecticide dimethoate in or on the raw agricultural commodities blueberries and asparagus (see Federal Register July 5, 1995, p. 34945) June 23, 1995 -- 60 FR 32640 |
The NTP has concluded that dimethoate is a "mutagenic" compound based on its testing for gene mutation and chromosomal aberrations. | 60-51-5 |
| Proposed | Proposal to delist di-(2-ethylhexyl) adipate from the reporting requirements under section 313 of the Emergency Planning and Community Right-to-Know Act of 1986 and section 6607 of the Pollution Prevention Act of1990 August 1, 1995 -- 60 FR 39132 |
As part of the relevant data, EPA used results of the NTP bioassay to conclude that, overall, the evidence is too limited to establish that di-(2-ethylhexyl) adipate is likely to cause cancer. TR 212. | 103-23-1 | |
| Notice | Thirty-Sixth Report of the TSCA ITC; Revision of Priority Testing List | The ITC is revising its Priority Testing List including the removal of butyraldehyde; sulfonyl bis(4-chlorobenzene); 2-propenoic acid,2-cyanoethyl ester; and dipropylene glycol from the List as a result of NTP testing. August 17, 1995 -- 60 FR 42981 |
The NTP has sponsored a reproductive screening test of butyraldehyde; has developed most of the screening test data and will be conducting health effects testing for sulfonyl bis(4-chlorobenzene); is currently testing a dipropylene glycol mixture; and is evaluating the practical problems which may prevent effective health effects testing of ethyl cyanoacrylate. | 123-72-8 25265-71-8 80-07-9 7085-85-0 |
| Final Rule | Benzidine-Based Chemical Substances; Proposed Significant New Uses of Certain Chemical Substances | The EPA is proposing a significant new use rule under section 5(a)(2) of TSCA which would require persons to notify EPA at least 90 days before commencing the manufacture, import, or processing of benzidine-based chemical substances. The EPA believes that benzidine-based chemical substances may be hazardous to human health and that the proposed rule will protect against potentially adverse exposure. August 30, 1995 -- 60 FR 45119 |
EPA supported, in part, their conclusion about the potential hazard of benzidine-based chemical substances on the results of three benzidine-based dye rodent studies reported by the NTP. TR-108. | 16071-86-6 2602-46-2 1937-37-7 |
| Proposed Rule | Diethyl Phthalate; Toxic Chemical Release Reporting: Community Right-to-Know | EPA is proposing to delete diethyl phthalate (DEP) from the list of chemicals subject to reporting requirements under section 313 of the Emergency Planning and Community Right-to-Know Act of 1986 and section 6607 of the Pollution Prevention Act of 1990. September 5, 1995 -- 60 FR 46076 |
As part of the relevant data, EPA used results of the NTP dermal bioassay to conclude that there is insufficient evidence to establish that DEP is likely to cause cancer. TR-429. | 84-66-2 |
| Notice | Dichlorvos; Notice of Preliminary Determination to Cancel Certain Registrations and Draft Notice of Intent to Cancel | EPA's issued this Notice to inform the public that the Agency has, after reviewing additional study date, reassessed the potential adverse effects and the benefits associated with the use of pesticide products containing dichlorvos. The Agency has preliminarily determined that, unless the terms and conditions of registration are modified as proposed in this Notice, the risks from the use of dichlorvos outweigh the benefits of their continued use. September 28, 1995 -- 60 FR 50337 |
As part of the relevant data, the EPA has classified dichlorvos as a Group C (possible human) carcinogen based on the results of the NTP bioassay (TR-342) and on the conclusions of a special NTP Panel of Experts convened April 1988 to further assess the incidence of pancreatic lesions observed in the 2-year rat studies. | 62-73-7 |
| Proposed Rule | Dichlorvos; Notice of Preliminary Determination to Cancel Certain Registrations and Draft Notice of Intent to Cancel | EPA proposes to establish a tolerance for residues of the insecticide diflubenzuron in or on the raw agricultural commodity artichokes at 6.0 ppm. Para-chloroaniline (PCA) is a metabolite of diflubenzuron. April 17, 1996 -- 61 FR 16745 |
The EPA's Health Effects Division Peer Review Committee classified PCA as a Group B2 carcinogen (probable human carcinogen) based on the results of the NTP chronic study of p-chloroaniline hydrochloride (TR-351). | 20265-96-7 |
| Notice | Dichlorvos; Notice of Preliminary Determination to Cancel Certain Registrations and Draft Notice of Intent to Cancel | The EPA announced the publication of the new "Proposed Guidelines for Carcinogen Risk Assessment" which replaces the 1986 guidelines. April 23, 1996 -- 61 FR 17960 |
Default assumptions are recognized as necessary in risk assessment ( National Research Council report) and the EPA has incorporated into its risk assessment guidelines default assumptions in part using inferences based on general scientific knowledge. The studies and experience of the NTP are cited and referred to throughout this Federal Register notice as part of the scientific knowledge used by the EPA to develop their defaults and how they plan their assessment of evidence of toxicity. | N/A |
| Proposed Rule | Dichlorvos; Notice of Preliminary Determination to Cancel Certain Registrations and Draft Notice of Intent to Cancel | EPA proposes to establish a pesticide tolerance for residues of the insecticidal fluorine compounds cryolite and or synthetic cryolite. Fluoride has been identified as the residue of toxicological concern in cryolite and synthetic cryolite. May 8, 1996 -- 61 FR 20781 |
The NTP chronic study of sodium fluoride (TR-393) was cited as an example of toxicological data considered in the support of the proposed tolerance and regulation. | 7681-49-4 |
| Proposed Rule | Food Additives Permitted for Direct Addition to Food for Human Consumption: Olestra | EPA is proposing a test rule under section 4(a) of the Toxic Substances Control Act to require manufacturers and processors of 21 hazardous air pollutants (HAPs) to test these substances for certain health effects. June 26, 1996 -- 61 FR 33178 |
As part of the process to select which study data were needed for these HAPs, EPA reviewed the NTP's database of ongoing testing to locate unpublished studies. | N/A |
| Final Rule | Food Additives Permitted for Direct Addition to Food for Human Consumption: Olestra | The EPA is promulgating a new use rule which requires persons to notify the EPA at least 90 days before commencing the manufacture, import, or processing of certain (22) benzidine-based chemical substances for significant new use as described in this rule. October 7, 1996 -- 61 FR 52287 |
As part of the basis for this significant new use rule, EPA noted that NIOSH and NCI jointly recommended that three benzidine-based dyes, Direct Black 38, Direct Blue 6, and Direct Brown 95, be handled in the workplace as if they were human carcinogens. This recommendation was based on testing data including the NTP/NCI bioassay which confirmed that these dyes cause cancer in rodents .(TR-108) | 16071-86-6 2602-46-2 1937-37-7 |
| Notice | Guidelines for Reproduction Toxicity Risk Assessment | Notice: The EPA has made available the final Guidelines for Reproductive Toxicity Risk Assessment. The Guidelines include protocols designed to determine the potential of a test substance to produce reproductive toxicity in laboratory animals. October 31, 1996 -- 61 FR 56274 |
NTP Work Cited: An NTP continuous breeding protocol, Fertility Assessment by Continuous Breeding, is cited as an example of alternative reproductive tests which the EPA considered in developing the Guidelines. | N/A |
| Proposed Rule | Supplement to California State Plan; Approval | EPA is denying a petition to remove the barium compounds category from the list of chemicals subject to reporting requirements under the Community Right-to-Know Act and the Pollution Prevention Act. The EPA concluded that barium ion can become available from the barium compounds subject to the reporting, and that barium ion can reasonably be anticipated to cause chronic toxicity. January 3, 1997 -- 62 FR 366 |
The EPA's toxicological evaluation of barium compounds included review of data from the NTP's Drinking Water Toxicity/Carcinogenicity Studies of Barium Chloride Dihydrate (TR-432). | 10326-27-9 |
| Final Rule | Indirect Food Additives: Adhesives and Components of Coatings; Adjuvants, Production Aids and Sanitizers | Final Rule: The FDA is amending the food additive regulations to provide for the safe use of 2,2-ethylidenebis(4,6-di-tert-butylphenyl)fluorophosphonite as an antioxidant in adhesives and in the preparation of polymers intended for contact with food. Although the additive itself has not been shown to cause cancer, it has been found to contain minute amounts of methylene chloride, which is a carcinogenic impurity resulting from the manufacture of the additive. January 15, 1997 -- 62 FR 2011 |
The FDA used data from the NTP Inhalation Bioassay on Methylene Chloride, TR-306, to estimate the upper-bound limit of lifetime human risk from exposure resulting from the proposed use of this additive. And, based on its estimates of worst case exposure, the FDA concluded that there is reasonable certainty that no harm from exposure to methylene chloride would result from the proposed use of the additive. | 75-09-2 |
| Proposed Rule | Addition of Dioxin and Dioxin-Like Compounds; Modification of Polychlorinated Biphenyls Listing; Toxic Chemical Release Reporting; Community Right-to-Know | The EPA is proposing to add a chemical category that includes dioxin and 27 dioxin-like compounds to the list of toxic chemicals subject to the reporting requirements under EPCRA. May 7, 1997 -- 62 FR 24887 |
As part of the basis for this proposed rule, the EPA noted that the NTP bioassays of 1,2,3,6,7,8- and 1,2,3,7,8,9-hexachlorodibenzo-p-dioxin (TR-198) showed that these compounds are carcinogenic. The EPA also noted that the NTP's Annual Report on Carcinogens listed PCBs as substances which may reasonably be anticipated to be human carcinogens. | N/A |
| Notice | Announcement of the Drinking Water Contaminant Candidate List | The Safe Drinking Water Act (SDWA) requires the EPA to publish a list of contaminants that are known or anticipated to occur in public water systems and which may require regulation under the SDWA. The EPA has reviewed and considered public comments of the draft CCL in creating the final CCL. March 2, 1998 -- 63 FR 10274 |
As part of its evaluation of the risk associated with methyl bromide's contamination of drinking water, the EPA cited the results of the NTP 2-year inhalation study (TR-385). | 74-83-9 |
| Final Rule | Organobromine Production Wastes; Identification and Listing of Hazardous Waste; Land Disposal Restrictions; Listing of CERCLA Hazardous Substances, Reportable Quantities | EPA is adding tribromophenol and wastes generated from its production to its list of CERCLA hazardous substances. EPA used structure activity relationship (SAR) analysis information in support of its listing of tribromophenol. May 4, 1998 -- 63 FR 24596 |
NTP mutagenicity studies are cited to show that a negative in Salmonella does not necessarily predict that 2,4,6-trichlorophenol is not a carcinogen. As part of its validation of the use of SAR analysis for identifying hazardous wastes, EPA cited a comparison of the NTP bioassay of 1,2-dibromoethane (TR-210) with the NCI bioassay of 1,2-dichloroethane (TR-55). The study results showed that carcinogenic activity was retained with the substitution of a chlorine by a bromine. |
88-06-2 106-93-4 107-06-2 |
| Final Rule | Diflubenzuron; Temporary Pesticide Tolerance | This regulation establishes a temporary tolerance for residues of the insecticide diflubenzuron and metabolites convertible to p-chloroaniline (PCA) expressed as diflubenzuron on rice grain at 0.01 ppm. May 13, 1998 -- 63 FR 26481 |
PCA was classified as a Group B2 carcinogen (probable human carcinogen). The classification for PCA was based on the results of the NTP bioassay on p-chloroaniline hydrochloride (TR-351). The results of several NTP mutagenicity studies on PCA discussed in the bioassay report were also cited. | 20265-96-7 |
| Notice | Update on the Status of the Superfund Substance-Specific Applied Research Program | This Notice provides the status of ATSDR's Superfund mandated Substance-Specific Applied Research Program (SSARP). To date, 188 priority data needs have been identified for the 50 priority hazardous substances frequently found at waste sites. January 15, 1999 -- 64 FR 2759 |
The ATSDR maintains an interagency agreement (IAG) with NTP to conduct toxicologic testing of substances identified at National Priority List sites. Under this agreement, the NTP filled the toxicity priority data need for the immunotoxicology study of carbon tetrachloride. The NTP is currently addressing reproductive toxicity data needs for chlordane, endrin, and heptachor; the bioavailability of PCB's in soil; and dose-response data for di-n-butyl phthalate. | N/A |
| Notice | Acetonitrile: Community Right-to-Know Toxic Chemical Release Reporting | The EPA is denying a petition to remove acetonitrile from the list of chemicals subject to the reporting requirements under section 313 of the Emergency Planning and Community Right-to-Know Act of 1986 (EPCRA) and section 6607 of the Pollution Prevention Act of 1990 (PPA). March 5, 1999 -- 64 FR 10597 |
EPA reviewed all of the available data, including the NTP Technical Report of the Toxicology and Carcinogenesis of Acetonitrile (TR-447), to conclude that acetonitrile can reasonably be anticipated to cause serious or irreversible chronic health effects in humans, including neurotoxicity and death. | 75-05-8 |
| Final Rule | Diflubenzuron; Pesticide Tolerances | The EPA established tolerances for residues of the insecticide diflubenzuron and its metabolites 4-chlorophenylurea and 4-chloroaniline in/on rice grain at 0.02 ppm and rice straw at 0.8 ppm. April 19, 1999 -- 64 FR 19050 |
The 4-chloroaniline (PCA) metabolite was classified as a Group B2 carcinogen (probable human carcinogen) based on the results of the NTP bioassay on PCA (TR-351). The NTP bioassay and the results of several NTP mutagenicity studies on PCA discussed in the bioassay report were part of the information used to estimate dietary risk assessments. | 20265-96-7 |
| Final Rule | 1,3-Dichloropropene: Proposed Determination to Terminate Special Review | The EPA proposed to terminate the Special Review of 1,3-Dichloropropene (1,3-D). The EPA has determined that the benefits associated with the continued use of 1,3-D under the recently revised terms and conditions of 1,3-D's reregistration outweigh the risks. January 12, 2000 -- 65 FR 1869 |
The EPA classified 1,3-D as a probable, human carcinogen based on the review of data from carcinogenicity studies including the NTP Toxicology and Carcinogenesis Studies of Telone II (TR-269). | 542-75-6 |
| Final Rule | Notice of Filing a Pesticide Petition to Establish a Tolerance for Certain Pesticide Chemicals in or on Food. | The FDA is amending the food additive regulations to provide for the safe use of ethylene-norbornene copolymers as articles or components of articles in contact with dry food. Although the additive itself has not been shown to cause cancer, it has been found to contain minute amounts of benzene, a carcinogenic impurity resulting from the manufacture of the additive. January 21, 2000 -- 65 FR 3384 |
The FDA used data from the NTP Carcinogenicity Study of Benzene (TR-289), to estimate the upper-bound limit of lifetime human risk from exposure resulting from the use of the additive. And based on its estimates of worst case exposure, the FDA concluded that there is reasonable certainty that no harm from exposure to benzene would result from the proposed use of the additive. | 71-43-2 |
| Notice | Diflubenzuron; Pesticide Tolerances | The EPA has received a pesticide petition for establishing a tolerance for residues of diflubenzuron in or on the raw agricultural commodity rangeland grass at 6.0 ppm. P-Chloroaniline (PCA) is a metabolite of diflubenzuron. April 5, 2000 -- 65 FR 17872 |
Information from the NTP bioassay of p-Chloroaniline Hydrochloride, TR-351, was used to determine that the dietary risk from diflubenzuron-derived PCA is below EPA's level of concern. | 20265-96-7 |
| Final Rule | Vinclozolin; Pesticide Tolerances | The EPA has established tolerances for combined residues of vinclozolin and its metabolites containing the 3,5-dichloroaniline moiety in or on specific raw agricultural commodities. July 18, 2000 -- 65 FR 44453 |
The EPA used data from the NTP's p-Chloroaniline bioassay (TR-351) to help assess the carcinogenicity for structurally related chloroanilines. | 20265-96-7 |
| Final Rule | National Primary Drinking Water Regulations: Disinfectants and Disinfection Byproducts | The EPA is finalizing maximum residual disinfectant level goals (MRDLGs), maxiumum contaminant level goals (MCLGs), and National Primary Drinking Water Regulations (NPDWRs). The EPA believes the stage 1 Disinfection Byproducts Rule will reduce the levels of disinfectants and disinfection
byproducts in drinking water supplies. December 16, 2000 -- 63 FR 69391 |
The EPA used data from NTP bioassays on Bromodichloromethane (TR-321), Dibromochloromethane (TR-282), Bromoform (TR-350) , and Chlorine (TR-392) in establishing the MCLGs and MRDLGs for these chemicals in drinking water supplies. The EPA also referred to the ongoing and planned NTP water disinfection byproduct studies. | N/A |
| Final Rule | Lead and Lead Compounds: Lowering of Reporting Thresholds | The EPA is lowering the reporting thresholds for lead and lead compounds which are subject to reporting under section 313 of the Emergency Planning and Community Right-to-Know Act and section 6607 of the Pollution Prevention Act. January 17, 2001 -- 66 FR 4500 |
Commenters contended that the Persistant Bioaccumulative Toxic Chemicals (PBT) rule framework was designed only for organic substances and is being incorrectly applied to metals. The EPA disagreed citing, as an example, the NTP's criteria for characterizing chemical carcinogens is the same for organic as well as inorganic substances to support its position that it is scientifically valid to establish generic criteria that are applicable to all substances. (8th Report on Carcinogens) | N/A |
| Final Rule | Control of Air Pollution from New Motor Vehicles: Heavy-Duty Engine and Vehicle Standards and Highway Diesel Fuel Sulfur Control Requirements. | The EPA is setting new diesel exhaust emission standards for heavy-duty highway engines to protect the public's health. Health studies indicate potential hazards that appear to be related to acute and chronic exposure. January 18, 2001 -- 66 FR 5002 |
The EPA cited the NTP as an example of a governmental agency that has identified diesel exhaust particles as reasonably anticipated to be a human carcinogen.(Ninth Report on Carcinogens). | N/A |
| Final Rule | National Advisory Committee for Acute Exposure Guidelines Levels (AEGLs) for Hazardous Substances; Proposed AEGL Values. | The EPA is proposing AEGLs for 18 chemicals to provide Federal, State, and local agencies with threshold short-term exposure limits for the public to hazardous, airborne chemicals. May 2, 2001 -- 66 FR 21940 |
The EPA used data from the NTP Toxicology and Carcinogenesis Studies of Tetrachloroethylene (TR-311) and Tetranitromethane (TR-386) in determining the proposed AEGL values for these two chemicals. | 509-14-8 127-18-4 |
| Final Rule | International Conference on Harmonisation; Draft Recommendations for the Revision of the Permitted Daily Exposures for Two Solvents,N-Methylpyrrolidone and Tetrahydrofuran. | The EPA established tolerances for combined residues of the insecticide diflubenzuron and its metabolites 4-chlorophenylurea and 4-chloroaniline (PCA) in or on pear. February 15, 2002 -- 67 FR 7085 |
Information from the NTP bioassay of p-Chloroaniline Hydrochloride, TR-351, was used to establish the tolerance of diflubenzuron and its metabolites 4-chlorophenylurea and 4-chloroaniline at .50 ppm in or on pears. | 20265-96-7 |
| Notice | International Conference on Harmonisation; Draft Recommendations for the Revision of the Permitted Daily Exposures for Two Solvents,N-Methylpyrrolidone and Tetrahydrofuran. | The EPA is proposing AEGLs for 8 chemicals to provide Federal, State, and local agencies with threshold short-term exposure to hazardous airborne chemicals. February 15, 2002 -- 67 FR 7164 |
The EPA used data from the NTP Toxicology and Carcinogenesis Studies of Propylene Oxide (TR-267) in determining the proposed AEGL values for propylene oxide. | 75-56-9 |
| Final Rule | Indirect Food Additives: Polymers | EPA intends to reclassify eight inert ingredients from List 2, Potentially Toxic Inerts/High Priority for Testing to List 1 Inerts of Toxicological Concern. One of the criteria for being considered a List 1 inert ingredient is to be characterized by the NTP as an animal carcinogen in at least one species and sex. March 8, 2002 -- 67 FR 10718 |
The EPA used data from the NTP Toxicology and Carcinogenesis Studies of 2-Benzyl-4-chlorophenol (TR-424), 2-Butoxyethanol (TR-484), Butyl benzyl Phthalate (TRs 213 & 458), Diethanolamine (TR-478), Ethylbenzene (TR-466), 1,2-Epoxybutane (TR-329), 2-Mercaptobenzothiazole (TR-332), and Nitromethane (TR-461) to support its reclassification of these inert ingredients to List 1. (TR-444) | 100-41-4 106-88-7 149-30-4 120-32-1 85-68-7 111-42-2 75-52-5 111-76-2 |
| Notice | Indirect Food Additives: Polymers | The EPA is soliciting public comment on whether a preliminary determination that nine contaminants do not meet all three Safe Drinking Water Act requirements is appropriate, and thus no National Primary Drinking Water Regulations (NPDWR) should be considered for these contaminants. June 3, 2002 -- 67 FR 38222 |
The EPA used data from the NTP Toxicity Studies of Hexachloro-1,3-butadiene, (TOX- 1) and Naphthalene (TR-410) & (TR-500) in determining that NPDWRs should not be considered for these contaminants. | 91-20-3 87-68-3 |
| Notice | Sucrose Octanoate Esters; Exemption from the Requirement of a Tolerance | The EPA has established an exemption from the tolerance requirements pursuant to FFDCA 408(c) and 9(d) for residues of certain Sucrose Octanoate Esters (SOEs) in or on all food commodities when applied/used in accordance with good agricultural practices. September 25, 2002 -- 67 FR 60146 |
The EPA has determined, based on available toxicology data including data from an NTP genetic toxicology study, that no harm will result from aggregate exposure of residues of SOEs to the U.S. population. | 124-07-2 |
| Notice | National Primary Drinking Water Regulations: Stage 2 Disinfectants and Disinfection Byproducts Rule | The EPA is proposing maximum contaminant level goals (MCLGs) for chloroform, monochloroacetic acid and trichloroacetic acid;National Primary Drinking Water Regulations for total trihalomethanes and haloacetic acids; and revisions to the reduced monitoring requirements for bromates. August 18, 2003 -- 68 FR 49548 |
The EPA used data from the NTP Toxicology and Carcinogenesis Studies of Bromodichloromethane (TR-321), Tribromomethane (TR-350), and Monochloroacetic Acid (TR-396) in determining the MCLGs for water disinfection byproducts. | 79-11-8 75-25-2 75-27-4 |
| Proposed | List of Hazardous Air Pollutants, Petition Process, Lesser Quantity Designations, Source Category List | The EPA proposes to amend the list of hazardous air pollutants contained in section 112(b)(1) of the Clean Air Act by removing ethylene glycol monobutyl ether from the group of glycol ethers. November 21, 2003 -- 68 FR 65648 |
The EPA used data from the NTP's 2-year inhalation study (TR-484) in considering the removal of EGBE from the list of hazardous air pollutants. |
111-76-2 |
| 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 |
| 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 |
| 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 |
| 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 |
| Notice | Isophorone; Notice of Filing a Pesticide Petition to Establish a Tolerance for a Certain Pesticide Chemical in or on Food | This notice announces the initial filing of a pesticide petition proposing the establishment of regulations for residues of a certain pesticide chemical in or on various food commodities. April 27, 2005 -- 70 FR 21767 |
In an oral gavage chronic toxicity/oncogenicity study conducted by the National Toxicology Program at dose levels of 0, 250 and 500 mg/kg/day in F344 rats and B6C3F1 mice, there was some evidence of carcinogenicity of isophorone in male rats (kidney tumors, preputial gland carcinomas). (TR-291) | 78-59-1 |
| Final Rule | Pinene Polymers; Exemption from the Requirement of a Tolerance | This regulation establishes exemptions from the requirement of a tolerance for residues of several alpha and/or beta-pinene polymers when used as inert ingredients in or on growing crops and when applied to raw agricultural commodities after harvest. Hercules, Inc. submitted a petition to EPA under the Federal Food, Drug, and Cosmetic Act (FFDCA), as amended by the Food Quality Protection Act of 1996 (FQPA), requesting an exemption from the requirement of a tolerance. This regulation eliminates the need to establish a maximum permissible level for residues of alpha and/or beta-pinene polymers. May 18, 2005 -- 70 FR 28447 |
The data considered in this assessment included information submitted by the petitioner, and information located by OPP on the internet, primarily information prepared by the National Toxicology Program (NTP) and the robust summaries for bicyclic terpene hydrocarbons submitted in 2002 to EPA by the Terpene Consortium of the Flavor and Fragrance High Production Volume Consortia (FFHPVC). | N/A |
| Final Rule | National Emission Standards for Hazardous Air Pollutants: Final Standards for Hazardous Air Pollutants for Hazardous Waste Combustors (Phase I Final Replacement Standards and Phase II) | This action finalizes national emission standards for hazardous air pollutants for hazardous waste combustors: hazardous waste burning incinerators, cement kilns, lightweight aggregate kilns, industrial/commercial/ institutional boilers and process heaters, and
hydrochloric acid production furnaces. October 12, 2005 -- 70 FR 59402 |
A National Toxicology Program (NTP) study 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.
(TR-392) In 2001 the U.S. Department of Health and Human Services National Toxicology Program in their 9th Report on Carcinogens classified 2,3,7,8-TCDD as a known human carcinogen. (ROC) |
7782-50-5 and 7681-52-9 and 1746-01-6 |
| Final Rule | List of Hazardous Air Pollutants, Petition Process, Lesser Quantity Designations, Source Category List | EPA is amending the list of hazardous air pollutants contained in section 112 of the Clean Air Act by removing the compound methyl ethyl ketone (MEK) (2-Butanone) (CAS No. 78-93-3). This action is being taken in response to a petition submitted by the Ketones Panel of the American Chemistry Council (formerly the Chemical Manufacturers Association) on behalf of MEK producers and consumers to delete MEK from the HAP list. Petitions to remove a substance from the HAP list are permitted under section 112 of the CAA. December 19, 2005 -- 70 FR 75047 |
There is an absence of positive results in the majority of mutagenicity and genotoxicity tests which are designed to indicate the potential for carcinogenicity. Methyl ethyl ketone has been tested for activity in an extensive spectrum of in vitro and in vivo genotoxicity assays and has shown no evidence of genotoxicity in most conventional assays (National Toxicology Program, no date; World Health Organization 1992; Zeiger et al., 1992). While developing the final rule, EPA learned that preliminary results of a recent cancer bioassay by the National Toxicology Program suggested that methyl isobutyl ketone (MIBK) appears to be a weak or marginally active carcinogen in rats and mice, possibly by a nongenotoxic mode of action. (TR-538) |
78-93-3 and 108-10-1 |
| Proposed | National Perchloroethylene Air Emission Standards for Dry Cleaning Facilities | EPA is proposing revised standards to limit emissions of
perchloroethylene (PCE) from existing and new dry cleaning facilities. December 21, 2005 -- 70 FR 75884 |
NTP technical report on the toxicology and carcinogenesis of tetrachloroethylene (perchloroethylene) (CAS No. 127-18-4) in F344/N rats and B6C3F1 mice (inhalation studies) National Toxicology Program, Research Triangle Park, NC. (TR-311), NIH Publication No. 86-2567. August 1986. | 127-18-4 |
| Final Rule | National Primary Drinking Water Regulations: Stage 2 Disinfectants and Disinfection Byproducts Rule | The Environmental Protection Agency (EPA) is promulgating today's final rule, the Stage 2 Disinfectants and Disinfection Byproducts Rule (DBPR), to provide for increased protection against the potential risks for cancer and reproductive and developmental health effects associated with disinfection byproducts (DBPs). January 4, 2006 -- 71 FR 388 |
Two-year bioassays by the National Toxicology Program (NTP) released in abstract form have recently been completed on BDCM and chlorate. The draft abstract on BDCM reported no evidence of carcinogenicity when BDCM was administered via drinking water (NTP 2005a). Another recent study, a modified two-year bioassay on BDCM in the drinking water, reported little evidence of carcinogenicity (George et al. 2002). In a previous NTP study, tumors were observed, including an increased incidence of kidney, liver, and colon tumors, when BDCM was administered at higher doses by gavage in corn oil (NTP 1987). EPA will examine new information on BDCM as it becomes available. In the chlorate draft abstract, NTP found some evidence that it may be a carcinogen (NTP 2004). Chlorate is a byproduct of hypochlorite and chlorine dioxide systems. A long-term, two-year bioassay NTP study on DBA is also complete but has not yet undergone peer review (NTP 2005b). (TR-321)(TR-532) (GMM-5) (TR-517) (TR-537) | 75-27-4 7775-09-9 and 631-64-1 |
| Proposed | Export Notification; Proposed Change to Reporting Requirements | EPA is proposing amendments to the Toxic Substances Control Act (TSCA) section 12(b) export notification regulations at subpart D of 40 CFR part 707. One amendment would change the current annual notification requirement to a one-time requirement for exporters of chemical substances or mixtures (hereinafter referred to as "chemicals") for which certain actions have been taken under TSCA. Relatedly, for the same TSCA actions, EPA is proposing to change the current requirement that the Agency notify foreign governments annually after the Agency's receipt of export notifications from exporters to a requirement that the Agency notify foreign governments once after it receives the first export notification from an exporter. EPA is also proposing de minimis concentration levels below which notification would not be required for the export of any chemical for which export notification under TSCA section 12(b) is otherwise required, proposing other minor amendments (to update the EPA addresses to which export notifications must be sent, to indicate that a single export notification may refer to more than one section of TSCA where the exported chemical is the subject of multiple TSCA actions, and to correct an error), and clarifying exporters' and EPA's obligations where an export notification-triggering action is taken with respect to a chemical previously or currently subject to export notification due to the existence of a previous triggering action. February 9, 2006 -- 71 FR 6733 |
EPA is proposing that export notification would not be required for such chemicals if the chemical is being exported at a concentration of less than 1% (by weight or volume), unless that chemical is listed as a "known to be human carcinogen" or "reasonably anticipated to be human carcinogen" in the Report on Carcinogens issued by the U.S. Department of Health and Human Services National Toxicology Program.
(ROC). |
N/A |
| Proposed | Ethylenediaminetetraacetic Acid Chemicals: Exemptions from the Requirement of a Tolerance | The Agency is proposing to establish 16 new and amend three existing exemptions from the requirement of a tolerance for residues of various ethylenediaminetetraacetic acid (EDTA) chemicals in or on raw agricultural commodities when used as inert ingredients in pesticide formulations applied to growing crops or to raw agricultural commodities after harvest under the Federal Food, Drug, and Cosmetic Act (FFDCA), as amended by the Food Quality Protection Act of 1996 (FQPA). This regulation eliminates the need to establish a maximum permissible level for residues of these EDTA chemicals. March 8, 2006 -- 71 FR 11563 |
The toxicological profile data considered in this assessment included information located by the Office of Pesticide Programs on the internet, studies conducted by the National Toxicology Program (NTP) and the National Cancer Institute (NCI), several work products produced by the Cosmetic Ingredient Review, several evaluations by the World Health Organization, and articles from open literature. Based on the available toxicity data on ethylenediaminetetraacetic acid (EDTA) and its various salts, with particular emphasis on the comparison of the findings in the two developmental toxicity studies; the reviews and evaluations conducted by NTP, NCI, and WHO; the knowledge that trace metal supplementation occurs via the food and drinking water consumed by human beings; and considering the estimated exposures of the wide-spread existing uses of ethylenediaminetetraacetic acid (EDTA) and its various salts which are less than levels at which adverse effects were noted, EPA concludes that there is a reasonable certainty of no harm from aggregate exposure to residues of ethylenediaminetetraacetic acid (EDTA) and its various salts. (TR-11) |
150-38-9 |
| Final Rule | Testing of Certain High Production Volume Chemicals | EPA is promulgating a final rule under the Toxic Substances Control Act that requires manufacturers (including importers) and processors of 17 high production volume chemicals to conduct acute toxicity, repeat dose toxicity, developmental and reproductive toxicity, genetic toxicity (gene mutations and chromosomal aberrations), ecotoxicity (in fish, Daphnia, and algae), and environmental fate (including 5 tests for physical chemical properties and biodegradation) testing. March 16, 2006 -- 71 FR 13708 |
With one exception, the "Class 1" chemical substances listed in Table 2 in § 799.5085(j) of the regulatory text (i.e., 12 of the 17 chemical substances included in this final rule) must be tested at a purity of at least 99%. The exception is 1,3-propanediol, 2,2-bis[(nitrooxy)methyl]-,dinitrate (ester) also known as pentaerythritol tetranitrate (PETN), which cannot be tested at 99% purity because of its explosive properties and must either be diluted in water or tested in a mixture with an appropriate stabilizing compound (e.g., D-lactose monohydrate is the stabilizer in PETN, NF which is a mixture that is 20% by weight PETN and 80% by weight Dlactose monohydrate). PETN, NF is the form of PETN which was tested by NTP in several toxicity studies. U.S. Department of Health and Human Services. National Institutes of Health. NTP. Toxicology and carcinogenesis studies of pentaerythritol tetranitrate in F344/N rats and B6C3F1 mice (feed studies). (TR-365). |
78-11-5 |
| Proposed | Control of Hazardous Air Pollutants From Mobile Sources | Today EPA is proposing controls on gasoline, passenger vehicles, and portable gasoline containers (gas cans) that would significantly reduce emissions of benzene and other hazardous air pollutants ("mobile source air toxics"). Benzene is a known human carcinogen, and mobile sources are responsible for the majority of benzene emissions. The other mobile source air toxics are known or suspected to cause cancer or other serious health effects. March 29, 2006 -- 71 FR 15804 |
The National Institute of Environmental Health Sciences recently nominated formaldehyde for reconsideration as a known human carcinogen under the National Toxicology Program. Since 1981 it has been listed as a "reasonably anticipated human carcinogen." (ROC) |
50-00-0 |
| Final Rule | Ethylene Oxide Emissions Standards for Sterilization Facilities | This action finalizes our decision not to revise the Ethylene Oxide Emission Standards for Sterilization Facilities, originally promulgated on December 6, 1994. Within 8 years of promulgating these standards, the Clean Air Act directs us to assess the risk and to promulgate more stringent standards if necessary to protect public health with an ample margin of safety and to prevent adverse environmental effects. Also, within 8 years of promulgating the national emission standards, the Clean Air Act requires us to review and revise the standards as necessary, taking into account developments in practices, processes, and control technologies. Today¿s action reflects our findings that after conducting these risk and technology reviews, no additional control requirements are warranted. April 7, 2006 -- 71 FR 17712 |
In 1994, the International Agency for Research on Cancer categorized ethylene oxide in their Group 1 (Carcinogenic to Humans). In 2000, the United States Department of Health and Human Services revised its listing for ethylene oxide to "known to be a human carcinogen" in the Ninth Report on Carcinogens. DHHS. 2000. Report on Carcinogens, Eleventh Edition; United States Department of Health and Human Services, Public Health Service, National Toxicology Program. (ROC). |
N/A |
| Final Rule | Eucalyptus Oil; Exemption from the Requirement of a Tolerance | This regulation establishes an exemption from the requirement of a tolerance for residues of eucalyptus oil on honey and honeycomb when applied at 2 g or less eucalyptus oil per hive to suppress varroa mites. Brushy Mountain Bee farm, c/o IR-4 Project submitted a petition to EPA under the Federal Food, Drug, and Cosmetic Act (FFDCA), as amended by the Food Quality Protection Act of 1996 (FQPA), requesting an exemption from the requirement of a tolerance. This regulation eliminates the need to establish a maximum permissible level for residues of eucalyptus oil in honey and honeycomb. September 13, 2006 -- 71 FR 53974 |
National Toxicology Program. 1982. Salmonella assay for genetic toxicity from exposure to 1,8 cineole. Study 246429. National Toxicology Program. 1982. CHO cell cytogenetics; chromosome aberrations and sister chromatid exchanges from exposure to 1,8 cineole. Study 590755. |
470-82-6 |
| Notice | Request for Nominations of Drinking Water Contaminants for the Contaminant Candidate List | The Environmental Protection Agency (EPA) is requesting nominationsof chemical and microbial contaminantsfor possible inclusion in the third drinking water Contaminant Candidate List (CCL 3). EPA is also requesting information that shows the nominated contaminant may have an adverse health effect on people and the contaminant occurs or is likely to occur. September 16, 2006 -- 71 FR 60704 |
N/A | N/A |
| Proposed | Proposed Test Rule for Certain Chemicals on the ATSDR/EPA CERCLA Priority List of Hazardous Substances | EPA is proposing to require testing for certain chemicals on the Agency for Toxic Substances and Disease Registry (ATSDR)/EPA Priority List of Hazardous Substances which is compiled under the Comprehensive Environmental Response Compensation and Liability Act (CERCLA), and is soliciting proposals for enforceable consent agreements (ECAs). EPA is proposing a test rule under section 4(a) of the Toxic Substances Control Act (TSCA) that would require manufacturers (including importers) and processors of four chemical substances (chloroethane, hydrogen cyanide, methylene chloride, and sodium cyanide) to conduct testing for certain health effects relating to the manufacture, distribution in commerce, processing, use, or disposal of these substances. October 20, 2006 -- 71 FR 61926 |
The toxicological profiles are developed by ATSDR in collaboration with EPA and NTP, independent peer reviewers, and the public. | N/A |
| Final Rule | Export Notification; Change to Reporting Requirements | EPA is promulgating amendments to the Toxic Substances Control Act (TSCA) section 12(b) export notification regulations at subpart D of 40 CFR part 707. One amendment changes the current annual notification requirement to a one-time requirement for exporters of chemical substances or mixtures (hereinafter referred to as "chemicals") for which certain actions have been taken under TSCA. Relatedly, for the same TSCA actions, EPA is changing the current requirement that the Agency notify foreign governments annually after the Agency's receipt of export notifications from exporters to a requirement that the Agency notify foreign governments once after it receives the first export notification from an exporter. EPA is also promulgating de minimis concentration levels below which notification will not be required for the export of any chemical for which export notification under TSCA section 12(b) is otherwise required, promulgating other minor amendments (to update the EPA addresses to which export notifications must be sent, to indicate that a single export notification may refer to more than one section of TSCA where the exported chemical is the subject of multiple TSCA actions, and to correct an error in 40 CFR 799.19 that currently omits mentioning multi-chemical test rules as being among those final TSCA section 4 actions that trigger export notification), and clarifying exporters' and EPA's obligations where an export notification- triggering action is taken with respect to a chemical previously or currently subject to export notification due to the existence of a previous triggering action. November 14, 2006 -- 71 FR 66234 |
EPA will consider the lists maintained by the World Health Organization, International Agency for Research on Cancer (IARC) and the US Department of Health and Human Services, Public Health Service, National Toxicology Program (NTP) as the definitive sources. The NTP Report on Carcinogens is mandated by section 301(b)(4) of the Public Health Service Act, as amended (42 U.S.C. 201 et seq.), which stipulates that the Secretary of the Department of Health and Human Services shall publish an annual report which contains a list of all substances: • Which either are known to be carcinogens in humans or may reasonably be anticipated to be human carcinogens • To which a significant number of persons residing in the United States are exposed.
(ROC). |
N/A |
| Final Rule | Diflubenzuron; Pesticide Tolerances | This regulation establishes tolerances for combined residues of diflubenzuron and its metabolites 4-chlorophenylurea and 4-chloroaniline in or on brassica, leafy greens subgroup 5B, turnip greens, peanut, peanut hay, peanut oil, barley grain, barley hay, barley straw, oat grain, oat forage, oat hay, oat straw, wheat grain, wheat forage, wheat hay, wheat straw, aspirated grain fractions, and pummelo. The Interregional Research Project #4 requested these tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA), as amended by the Food Quality Protection Act of 1996 (FQPA). November 29, 2006 -- 71 FR 69028 |
The Agency has classified diflubenzuron as "Group E," evidence of non-carcinogenicity for humans, based on lack of evidence of carcinogenicity in rats and mice. There are also two metabolites of diflubenzuron; PCA and CPU. PCA tested positive for splenic tumors in male rats and hepatocellular adenomas/ carcinomas in male mice in a National Toxicology Program (NTP) study. (TR-351) | 35367-38-5 150-68-5 and 106-47-8 |
| Final Rule | Protection of Stratospheric Ozone: Listing of Substitutes for Ozone-Depleting Substances-n-Propyl Bromide in Solvent Cleaning | The Environmental Protection Agency (EPA) determines that n-propyl bromide (nPB) is an acceptable substitute for methyl chloroform and chlorofluorocarbon (CFC)-113 in the solvent cleaning sector under the Significant New Alternatives Policy (SNAP) program under section 612 of the Clean Air Act. The SNAP program reviews alternatives to Class I and Class II ozone depleting substances and approves use of alternatives which do not present a substantially greater risk to public health and the environment than the substance they replace or than other available substitutes. May 30, 2007 -- 72 FR 30142 |
These metabolic and subchronic inhalation studies conducted under the National Toxicology Program did not specifically examine for reproductive toxicity or nPB metabolism in target organs that control reproductive function. In summary, there is little available data about the metabolic activation or reactive metabolites responsible for reproductive toxicity in rodents. Similarly, for nPB, there is little information available about differences and similarities between rodents and humans. | N/A |
| Notice | Draft Toxicological Review of Bromobenzene: In Support of the Summary Information in the Integrated Risk Information System (IRIS) | EPA is announcing that the Oak Ridge Institute of Science and Education (ORISE), under an Interagency agreement between the Department of Energy and EPA, will convene an independent panel of experts and organize and conduct an external peer-review workshop to review the external review draft document titled, "Toxicological Review of Bromobenzene: In Support of Summary Information on the Integrated Risk Information System (IRIS" (NCEA-C-1497). The EPA also is announcing a public comment period for the draft document. EPA intends to consider comments and recommendations from the public and the expert panel meeting when EPA finalizes the draft document. June 14, 2007 -- 72 FR 32847 |
If you are requesting a paper copy, please provide your name, mailing address, and the document title. Copies are not available from ORISE. The National Toxicology Program studies referenced in the Toxicological Review of Bromobenzene are available by calling EPA's IRIS Hotline at (202) 566-1676, by fax at (202) 566-1749 or by e-mail at iris@epa.gov. | N/A |
| Notice | Draft Toxicological Review of Tetrahydrofuran: In Support of the Summary Information in the Integrated Risk Information System (IRIS) | EPA is announcing that the Oak Ridge Institute of Science and Education (ORISE), under an Interagency agreement between the Department of Energy and EPA, will convene an independent panel of experts and organize and conduct an external peer-review workshop to review the external review draft document titled, "Toxicological Review of Tetrahydrofuran: In Support of Summary Information on the Integrated Risk Information System (IRIS" (NCEA-S-1620). The EPA also is announcing a public comment period for the draft document. EPA intends to consider comments and recommendations from the public and the expert panel meeting when EPA finalizes the draft document. August 20, 2007 -- 72 FR 46483 |
The National Toxicology Program studies referenced in the Toxicological Review of Tetrahydrofuran are available by calling EPA's IRIS Hotline at 202-566-1676, by fax at 202-566-1749 or by e-mail at iris@epa.gov. | 109-99-9 |
| Notice | Sixty-Second 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 sixty-second report to the Administrator of EPA on April 17, 2008. In the 62nd ITC Report, which is included with this notice, the ITC is revising the TSCA section 4(e) Priority Testing List by removing four tungsten compounds and four cresols. May 12, 2008 -- 73 27450 |
The ITC is removing tungsten oxide (WO3), a.k.a. tungsten trioxide because of the voluntary information provided by the International Tungsten Industry Association and their cooperation in a National Toxicology Program/National Institute for Occupational Safety and Health research program to address exposure and toxicity data needs. The ITC is retaining tungstate (WO42-), disodium, dihydrate, (T-4)-, a.k.a. sodium tungstate (Na2 (WO4)), dihydrate (CAS No. 10213-10-2), on the Priority Testing List because of ongoing discussions with the International Tungsten Industry Association. | 1314-35-8 10213-10-2 |
| Final Rule | Control of Emissions of Air Pollution from Locomotive Engines and Marine Compression-Ignition Engines Less than 30 Liters per Cylinder; Republication | EPA is adopting a comprehensive program to dramatically reduce pollution from locomotives and marine diesel engines. The controls will apply to all types of locomotives, including line-haul, switch, and passenger, and all types of marine diesel engines below 30 liters per cylinder displacement, including commercial and recreational, propulsion and auxiliary. The near-term emission standards for newly-built engines will phase in starting in 2009. The near-term program also includes new emission limits for existing locomotives and marine diesel engines that apply when they are remanufactured, and take effect as soon as certified remanufacture systems are available, as early as 2008. The long-term emissions standards for newly-built locomotives and marine diesel engines are based on the application of high-efficiency catalytic after-treatment technology. These standards begin to take effect in 2015 for locomotives and in 2014 for marine diesel engines. We estimate particulate matter (PM) reductions of 90 percent and nitrogen oxides (NOX) reductions of 80 percent from engines meeting these standards, compared to engines meeting the current standards. June 30, 2008 -- 73 FR 37096 |
The National Toxicology Program listed naphthalene as "reasonably anticipated to be a human carcinogen" in 2004 on the basis of bioassays reporting clear evidence of carcinogenicity in rats and some evidence of carcinogenicity in mice. ROC
The IARC has determined that benzene is a human carcinogen and the U.S. DHHS has characterized benzene as a known human carcinogen.ROC |
91-20-3 71-43-2 106-99-0 75-07-0 |
| Other | Dichlorvos (DDVP); Order Denying NRDCs Objections and Requests for Hearing | In this order, EPA denies objections to, and requests for hearing on, a prior order denying a petition requesting that EPA revoke all pesticide tolerances for dichlorvos under section 408(d) of the Federal Food, Drug, and Cosmetic Act. The objections and hearing requests were filed on February 1, 2008, by the Natural Resources Defense Council (NRDC). The Original petition was also filed by NRDC. July 23, 2008 -- 73 FR 42683 |
In the 1989 NTP cancer studies with rats and mice, male and female reproductive organs (prostate, testes, epididymis, ovaries, uterus) were examined and no changes attributable to DDVP were found. TR-342 | 62-73-7 |
| Final Rule | Control of Emissions From Nonroad Spark-Ignition Engines and Equipment | We are setting emission standards for new non-road spark-ignition engines that will substantially reduce emissions from these engines. The exhaust emission standards apply starting in 2010 for new marine spark-ignition engines, including first-time EPA standards for stern-drive and inboard engines. The exhaust emission standards apply starting in 2011 and 2012 for different sizes of new land-based, spark-ignition engines at or below 19 kilowatts (kW). These small engines are used primarily in lawn and garden applications. We are also adopting evaporative emission standards for vessels and equipment using any of these engines. In addition, we are making other minor amendments to our regulations. October 8, 2008 -- 73 FR 59034 |
The International Agency for Research on Carcinogens (IARC) has determined that benzene is a human carcinogen and the U.S. Department of Health and Human Services (DHHS) has characterized benzene as a known human carcinogen.ROC |
71-43-2 106-99-0 75-07-0 91-20-3 |
| Total Notices | 234 | |||
| Notice Type | Title | Summary of Notice | NTP Information Cited | CAS Number |
|---|---|---|---|---|
| Other | Carcinogenic Chemicals in Food and Color Additives | FDA ANPR on setting a policy for regulating use of food and color additives containing carcinogens. April 2, 1982 -- 47 FR 14464 |
Reference to NIEHS report on species to species comparison of carcinogenicity data. | N/A |
| Final Rule | Irradiation of Food | FDA final rule to permit irradiation of additional herbs, spices, and vegetable seasonings. April 18, 1985 -- 50 FR 15415 |
FDA has referred USDA study to NTP for peer review. | N/A |
| Final Rule | Irradiation of Food | FDA final rule to permit irradiation of dry or dehydrated enzyme preparations. June 10, 1985 -- 50 FR 24190 |
NTP review, conducted at FDA's request, concluded that data did not demonstrate a carcinogenic response. | N/A |
| Proposed Rule | Certain Color Additives | FDA proposed rule to postpone closing dates on provisional listing of certain color additives. June 26, 1985 -- 50 FR 26377 |
NTP examined data on D Red Nos. 9 and 33 and concluded that there is a relationship between them that provides a basis for concern about the possible carcinogenicity of No. 33. (TR-225) | 5160-02-1 |
| Final Rule | Irradiation of Food | FDA final rule to permit gamma radiation of pork to control Trichinella Spiralis, citing NTP study which concluded that histopathological data did not show a carcinogenic response. July 22, 1985 -- 50 FR 29658 |
NTP review, conducted at FDA's request, concluded that data did not demonstrate a carcinogenic response. | N/A |
| Final Rule | Certain Color Additives | FDA final rule postponing closing dates for provisional listing of certain color additives to allow uninterrupted use while scientific evaluation continues. September 4, 1985 -- 50 FR 35783 |
NTP found a clear relationship between D Red No. 9, which has indicated carcinogenic effects and D Red No. 33 that provides a basis for concern about the possible carcinogenicity of No. 33. (TR-225) | 5160-02-1 |
| Final Rule | Cinnamyl Anthranilate | FDA final rule prohibiting use in human food. October 23, 1985 -- 50 FR 42929 |
NTP panel on Chemical Carcinogenesis Testing and Evaluation recommended continued use of the B55526 C55523 and F55521 mouse. | 87-29-6 |
| Proposed Rule | Methylene Chloride | FDA proposed rule to ban use in cosmetic products. December 18, 1985 -- 50 FR 51551 |
NTP studies concluded that methylene chloride is a carcinogen in mice and can induce cancer at sites remote from the site of administration. (TR-306) | 75-09-2 |
| Final Rule | Listing of D& C Orange No. 17 for Use in Externally Applied Drugs and Cosmetics | FDA final rule permanently listing D Orange No. 17 as a color additive for use in externally applied drugs and cosmetics. August 7, 1986 -- 51 FR 28331 |
NTP publication cited reporting 50% of 86 compounds tested by NTP between 7/81-7/84 were determined to induce some carcinogenic effect. | N/A |
| Final Rule | FD& C Yellow No. 6 | FDA final rule permanently listing FD Yellow No. 6 for use in food, drugs, and cosmetics. November 19, 1986 -- 51 FR 41765 |
"With the exception of the 1981 NCI/NTP bioassays that were done, the agency considered past studies as inadequate.." (TR-208) | 2783-94-0 |
| Final Rule | D& C Red No. 8 and No. 9 | FDA final rule permanently listing D Red No. 8 and No. 9 as color additives for use in lip products & externally applied drugs and cosmetics. December 5, 1986 -- 51 FR 43877 |
This regulation, based on a deminimus interpretation of the Delaney Clause was revoked following a federal court ruling. | 5160-02-1 |
| Final Rule | Indirect Food Additives | FDA final rule allowing use of an additive to paper products which come into contact with food, although the additive may contain minute amounts of methylene chloride as a byproduct of its production. May 27, 1987 -- 52 FR 19722 |
NTP-supported study of methylene chloride showed carcinogenicity in male and female mice. TR-306. | 75-09-2 |
| Final Rule | Cancer-Causing Residues in Edible Products of Food-Producing Animals | FDA final rule on procedures and criteria to ensure absence of such residues in animals to which drugs, food additives, or color additives have been administered. December 31, 1987 -- 52 FR 49572 |
References to NTP report on chemical carcinogenesis testing and evaluation. | N/A |
| Notice | D& C Red No. 8 and D& C Red No. 9 | FDA notice of denial of petition for listing for use in ingested lip products and in externally applied drugs and cosmetics. July 15, 1988 -- 53 FR 26886 |
NCI/NTP chronic rat study concluded that D Red No. 9 is carcinogenic for male F-344 rats. (TR-225) | 5160-02-1 |
| Final Rule | D& C Red No. 36 | FDA final rule permanently listing D Red No. 36 for general use except in eye area. August 2, 1988 -- 53 FR 29024 |
At FDA's request, NTP compared data on D Red No. 33 with D Red No. 9, a splenic carcinogen. (Nos. 33 and 36 were being considered jointly). (TR-225) | 5160-02-1 |
| Final Rule | Dimethyl Dicarbonate | FDA final rule amending food additive regulations to allow use as yeast inhibitor in wines. October 21, 1988 -- 53 FR 41325 |
NTP carcinogenesis bioassay of methyl carbamate which is produced in food by dimethyl dicarbonate. (TR-328) | 598-55-0 |
| Final Rule | Methylene Chloride (75-09-2) | FDA final rule banning use of methylene chloride as an ingredient of cosmetic products. June 29, 1989 -- 54 FR 27328 |
NTP concluded with respect to their inhalation study on methylene chloride that there was clear evidence of carcinogenicity in mice and female rats and some evidence of carcinogenicity in male rats. | 75-09-2 |
| Final Rule | 4,4'-Diphenylmethanediamine | FDA final rule amending food additive regulations to allow use of polyamide-imide resins in articles which come into contact with food. October 23, 1989 -- 54 FR 43168 |
Data from NTP carcinogenesis bioassay used to estimate upper-bound level of lifetime risk from proposed use of 4,4'-diiphenylmethanediamine. | N/A |
| Notice | Urethane in Alcoholic Beverages; Research and Survey Reports | The FDA announced the availability of research and survey reports on urethane in alcoholic beverages. March 23, 1990 -- 55 FR 10816 |
The FDA asked NTP to initiate research to provide the toxicology data necessary to estimate the risk from urethane in alcoholic beverages. | 51-79-6 |
| Proposed Rule | General and Plastic Surgery Devices; Effective Date of Requirement for Premarket Approval of Silicone Gel-filled Breast Prosthesis. | FDA is proposing to require the filing of a premarket approval application for the silicone gel-filled breast prosthesis. May 17, 1990 -- 55 FR 20568 |
Any PMA must include acute, subchronic, and chronic toxicity in vitro and in vivo studies. These studies should include a separate assessment of the carcinogenic risk for each substance contained in the implant. Studies should be performed in accordance with the guide-lines issued by the NTP for all aspects of conducting the assay. | N/A |
| Proposed Rule | Topical Acne Drug Products for Over-The Counter Human Use; Amendment of Tentative Final Monograph | Proposed Rule: Amendment to final monograph for over-the counter topical acne products. This amendment reclassifies the topical acne active ingredient benzoyl peroxide to a "more-data-needed" category. August 7, 1991 -- 56 FR 37622 |
Reference to NTP Init-Prom Comparative Mouse Study using different combinations of initiators and promoters including benzoyl peroxide. (TR-441) | INIT/PROM |
| Final Rule | Indirect Food Additives: Polymers | The FDA is amending the food additive regulations to provide for the safe use of polyestercarbonate resin. February 3, 1992 -- 57 FR 3938 |
Residual amounts of methylene chloride have been found in the additive. The FDA estimated the worst-case exposure to methylene chloride from the use of polyestercarbonate resin food-contact articles to be less than 15 micrograms per person per day. The FDA used data from TR-306 to estimate the upper-bound limit of lifetime human risk exposure to methylene chloride. | 75-09-2 |
| Final Rule | Indirect Food Additives: Paper and Paperboard Components | The FDA is amending the food additive regulations to provide for the safe use of ethyl acrylate in the manufacture of paper and paperboard intended for use in contact with food. August 7, 1992 -- 57 FR 34865 |
The FDA used data from TR-259 on ethyl acrylate to estimate the upper-bound limit of lifetime human risk from exposure. | 140-88-5 |
| Tentative Final Rule | Pesticide Tolerance and Animal Feed Additive Regulation for Fluoride Compounds | Tentative Final Rule: Tentative affirmation that gelatin is generally recognized as safe (GRAS) for use as a direct human food ingredient. May 12, 1993 -- 58 FR 27959 |
Data from the NTP toxicology and carcinogenesis study on pentachlorophenol (TR-349) showing PCP induces carcinogenic neoplasms in mice was used in modifying the regulation to state that there shall be no detectable levels of PCP in gelatin when tested by the method referenced in this regulation. | 87-86-5 |
| Final Rule | Indirect Food Additives: Adjuvants, Production Aids, and Sanitizers | Amendment of food additive regulations to provide for the safe use of 3,5-di-tert-butyl-4-hydroxyhydrocinnamic acid triester with 1,3,5-tris(2-hydroxyethyl)-s-triazine-2,4,6-(1H,3H,5H)-trione as an antioxidant for polyester elastomers in contact with dry food and rubber articles intended for repeated use in contact with food. January 19, 1994 -- 59 FR 2733 |
Because ethyl acrylate may be present in the additive, data from the NTP toxicology and carcinogenesis study on ethyl acrylate (TR-259) were used to estimate the upper-bound limit of lifetime human risk. | 140-88-5 |
| Final Rule | Food Additives Permitted for Direct Addition to Food for Human Consumption; Dimethyl Dicarbonate | Amendment to the food additive regulations to provide for the safe use of dimethyl dicarbonate as a yeast inhibitor in dealcoholized and low alcohol wines, Jan 26, 1993, and in ready-to-drink tea beverages. February 4, 1994 -- 59 FR 5317 |
NTP toxicology and carcinogenesis study on methyl carbamate (TR-328) was used to estimate the human cancer risk from the potential exposure to methyl carbamate stemming from the proposed use of dimethyl dicarbonate as a yeast inhibitor in wine. | 598-55-0 |
| Proposed Rule | Oral Health Care Drug Products for Over-the-Counter Human Use; Tentative Final Monograph for Oral Antiseptic Drug Products | Notification of proposed rulemaking in the form of a tentative final monograph that would establish conditions under which over-the-counter oral antiseptic drug products are generally recognized as safe and effective and not misbranded. February 9, 1994 -- 59 FR 6084 |
The FDA noted that benzethonium chloride is currently being evaluated for carcinogenic potential by the NTP. The agency also nominated gentian violet for study by the NTP after reviewing the available data and deciding that a definitive conclusion regarding its carcinogenic activity could not be reached. (TR-438) | 121-54-0 |
| Final Rule | Secondary Direct Food Additives Permitted in Food for Human Consumption: Cellulose Triacetate | Amendment of food additive regulations to provide for the safe use of cellulose triacetate as an immobilizing agent for lactase for use in reducing the lactose content of milk. July 20, 1994 -- 59 FR 36935 |
Data from the NTP toxicology and carcinogenesis study of dichloromethane (TR-306) was used to calculate the risk from exposure to dichloromethane as an impurity in cellulose triacetate. | 75-09-2 |
| Notice | International Conference on Harmonisation; Draft Guideline on Specific Aspects of Regulatory Genotoxicity Tests; Availability | Notification of publication of draft guideline "Notes for Guidance on Specific Aspects of Regulatory Genotoxicity Tests" to provide guidance on genotoxicity testing. September 22, 1994 -- 59 FR 48734 |
The test battery approach is designed to reduce the risk of false negative results. However, genotoxicity test batteries as described will only detect carcinogens that act primarily via a mechanism involving direct genetic damage. According to results of the NTP (Haseman, et al, 1990), approximately 15 percent of carcinogens are not detected by the commonly used batteries of genotoxicity tests. | N/A |
| Final Rule | Food Additives Permitted for Direct Addition to Food for Human Consumption; Acesulfame Potassium | Methylene chloride is used as a solvent in the initial step in the manufacturing process of acesulfame potassium and may be present as an impurity in the additive. The FDA used risk assessment procedures to estimate the upper-bound limit of risk presented by methylene chloride. December 1, 1994 -- 59 FR 61538 |
The FDA used data from the NTP bioassay on methylene chloride to calculate the potency, or unit risk, from exposure to this chemical. TR-306 | 75-09-2 |
| Proposed Rule | Gastroenterology-Urology Devices; Effective Date of the Requirement for Premarket Approval of the Implanted Mechanical/Hydraulic Urinary Continence Device | The FDA is proposing to require the filing of a premarket approval application for a medical device. The Agency is also summarizing its proposed findings regarding the degree of risk of illness or injury designed to be eliminated or reduced. February 15, 1995 -- 60 FR 8595 |
The FDA used the NTP bioassay on 4,4-Methylenedianiline Dihydrochloride in their evaluation of potential risk of polyurethane elastomer materials which may be present in the devices and may degrade over time and release degradation products which are potential carcinogens in animals. (TR-248) | 13552-44-8 |
| Final Rule | Dichlorvos; Notice of Preliminary Determination to Cancel Certain Registrations and Draft Notice of Intent to Cancel | The FDA is amending the food additive regulations to provide for the safe use of C.I. Pigment Yellow 138 as a colorant for all food-contact polymers. In its evaluation of the safety of this additive, the FDA has reviewed the safety of the additive itself and that of polychlorinated dibenzo-p-dioxins (PCDD) impurities resulting from the manufacturing process. January 25, 1996 -- 61 FR 2113 |
An independent pathology review analyzed slides of the liver tumors observed in the bioassay of TCDD using the NTP's 1986 classification system for liver tumors. The FDA used this classification to estimate carcinogenic risk. | N/A |
| Final Rule | Food Additives Permitted for Direct Addition to Food for Human Consumption: Olestra | The FDA is amending the food additive regulations to provide for the safe use of sucrose esterified with medium and long chain fatty acids (olestra) as a replacement for fats and oils. January 30, 1996 -- 61 FR 3117 |
The FDA used data from the NTP historical pathology database to support its rationale that there was no association between treatment with olestra and the incidence of leukemia developed by male rats during a 2-year carcinogenicity study. | N/A |
| Final Rule | Food Additives Permitted for Direct Addition to Food for Human Consumption: Olestra | The Food and Drug Administration (FDA) is amending the food additive regulations to provide for the safe use of polyaryletherketone resins as a basic resin for use in food-contact materials. Although the additive itself has not been shown to cause cancer, it has been found to contain minute amounts of methylene chloride, which is a carcinogenic impurity resulting from the manufacture of the additive. August 15, 1996 -- 61 FR 42379 |
The FDA used data from the NTP Bioassay on Methylene Chloride (TR-306) to estimate the upper-bound limit of lifetime human risk from exposure resulting from the proposed use of this additive. And, based on its estimates of worst case exposure, the FDA concluded that there is reasonable certainty that no harm from exposure to methylene chloride would result from the proposed use of the additive. | 75-09-2 |
| Final Rule | Food Additives Permitted for Direct Addition to Food for Human Consumption: Olestra | The Food and Drug Administration (FDA) is amending the food additive regulations to provide for the safe use of phosphorylated tall oil fatty acids as pigment dispersants in polymeric films intended for use in contact with food. Although the additive itself has not been shown to cause cancer, it has been found to contain minute amounts of dimethyl hydrogen phosphite, which is a carcinogenicimpurity resulting from the manufacture of the additive. August 21, 1996 -- 61 FR 43156 |
The FDA used the data from the NTP Bioassay on Dimethyl Hydrogen Phosphite (TR-287) to estimate the upper-bound limit of lifetime human risk from exposure resulting from the proposed use of theadditive. And, based on its estimates of worst case exposure, the FDA concluded that there is reasonable certainty that no harm from exposure to dimethyl hydrogen phosphite would result from the proposed use of the additive. | N/A |
| Final Rule | Indirect Food Additives: Polymers | The Food and Drug Administration (FDA) is amending the food additive regulations to provide for the safe use of a copolymer of ethyl acrylate, methyl methacrylate, and methacrylamide in combination with melamine-formaldehyde resin as a coating for polyethylene phthalate films intended for use in contact with food. Although the additive itself has not been shown to cause cancer, it has been found to contain minute amounts of unreacted ethyl acrylate, which is a carcinogenic impurity resulting from the manufacture of the additive. September 5, 1996 -- 61 FR 46719 |
The FDA used the data from the NTP Bioassay on Ethyl Acrylate (TR-259) to estimate the upper-bound limit of lifetime human risk from exposure resulting from the proposed use of the additive. And, based on its estimates of worst case exposure, the FDA concluded that there is reasonable certainty that no harm from exposure to ethyl acrylate would result from the proposed use of the additive. | 140-88-5 |
| Final Rule | Indirect Food Additives: Adjuvants, Production Aids, and Sanitizers | Final Rule: The Food and Drug Administration (FDA) is amending the food additive regulations to provide for the safe use of 1,2-benzisothiazolin-3-one as a biocide in rubber latex for use in the manufacture of rubber articles intended for repeated use in contact with food. In its evaluation of the safety of this additive, the FDA has reviewed the safety of the additive itself and that of polychlorinated dibenzo-p-dioxins (PCDD) and dibenzo-p-dioxins impurities resulting from the manufacturing process. November 29, 1996 -- 61 FR 231 |
An independent pathology review reanalyzed slides of the liver tumors observed in a bioassay of TCDD using the NTP's 1986 classification system for liver tumors. The FDA used this classification to estimate carcinogenic risk. | N/A |
| Proposed Rule | Laxative Drug Products for Over-the-Counter Human Use: Proposed Amendment to the Tentative Final Monograph | As part of its ongoing review of OTC drug products, the FDA is proposing to amend the tentative final monograph for over-the-counter laxative drug products by reclassifying phenolphthalein from Category I (generally recognized as safe and effective) to Category II (not generally recognized as safe and effective). September 2, 1997 -- 62 FR 46223 |
Based on the results of NTP studies, the FDA considers use of phenolphthalein a potential risk to humans. The NTP findings of rodent carcinogenicity and genotoxicity in several test systems indicate that chronic use of phenolphthalein could lead to damage to the human genome and could increase the risk of malignancy. | 77-09-8 |
| Final Rule | Indirect Food Additives: Adjuvants, Production Aids, and Sanitizers | The FDA is amending the food additive regulations to provide for the safe use of 2,9-dichloro-5,12-dihydroquinone[2,3-b]acridine-7,14-dione (C.I. Pigment Red 202) as a colorant for polymers used in contact with food. Although the additive itself has not been shown to cause cancer, it has been found to contain minute amounts of para-chloroaniline, a carcinogenic impurity resulting from the manufacture of the additive. November 3, 1998 -- 63 FR 59213 |
The FDA used data from the NTP carcinogenicity study of para-Chloroaniline Hydrochloride (TR-351) to estimate the upper-bound limit of lifetime human risk from exposure resulting from the proposed use of the additive. And, based on its estimates of worst case exposure, the FDA concluded that there is reasonable certainty that no harm from exposure to para-chloroaniline would result from the proposed use of the additive | N/A |
| Final Rule | Diflubenzuron; Pesticide Tolerances | The FDA is issuing a final rule establishing that the over-the-counter stimulant laxative ingredients danthron and phenolphthalein are not generally recognized as safe and effective and are misbranded. January 29, 1999 -- 64 FR 4535 |
After reviewing all of the available data, including the NTP phenolphthalein studies, the FDA concluded that phenolphthalein caused chromosome aberrations, cell transformation, and mutagenicity in mammalian cells and is reasonably anticipated to have human carcinogenic potential. TR 465: Toxicology and Carcinogenesis Studies of Phenolphthalein in F344/N Rats and B6C3F1 Mice (Feed Studies) Dunnick JK et al., ;Phenolphthalein Induces Thymic Lymphomas Accompanied By Loss Of The P53 Wild Type Allele In Heterozygous P53-Deficient (+/-) Mice,; Toxicologic Pathology 1997, 25(6): 533-540. | N/A |
| Final Rule | Diflubenzuron; Pesticide Tolerances | The FDA is amending the food additive regulations to provide for the safe use of 4,5-dichloro-1,2-dithiol-3-one as a slimicide in the manufacture of food-contact paper and paperboard. Although the additive itself has not been shown to cause cancer, it has been found to contain minute amounts of tetrachloroethylene, a carcinogenic impurity resulting from the manufacture of the additive December 15, 1999 -- 64 FR 69898 |
The FDA used data from the NTP Carcinogenicity Study of Tetrachloroethylene (TR-311), to estimate the upper-bound limit of lifetime human risk from exposure resulting from the use of the additive. And based on its estimates of worst case exposure, the FDA concluded that there is reasonable certainty that no harm from exposure to tetrachloroethylene would result from the proposed use of the additive. | 127-18-4 |
| Final Rule | Vinclozolin; Pesticide Tolerances | The FDA is amending the food additive regulations to provide for the safe use of hydrogenated butadiene/acrylonitrile copolymers intended for contact with food in repeated use applications. Although the additive itself has not been shown to cause cancer, it has been found to contain residual amounts of acrylonitrile and butadiene, carcinogenic impurities resulting from the manufacture of the additive. November 15, 2000 -- 65 FR 68888 |
The FDA used data from the NTP Carcinogenicity Study of 1,3-Butadiene, (TR-434), to estimate the upper-bound limit of lifetime human risk from exposure resulting from the use of the additive. And based on its estimates of worst case exposure, the FDA concluded that there is reasonable certainty that no harm from exposure to butadiene would result from the proposed use of the additive. | 106-99-0 |
| Notice | International Conference on Harmonisation; Draft Recommendations for the Revision of the Permitted Daily Exposures for Two Solvents,N-Methylpyrrolidone and Tetrahydrofuran. | The Food and Drug Administration is announcing the availability of draft recommendations for the revision of the permitted daily exposures (PDE) for n-methylpyrrolidone and tetrahydrofuran. February 12, 2002 -- 67 FR 6542 |
Based on data from NTP Carcinogenicity Studies of Tetrahydrofuran, (TR-475), the ICH Steering Committee recommended that tetrahydrofuran be moved from class 3 into class 2. | 109-99-9 |
| Final Rule | New Animal Drugs: Phenylbutazone; Extralabel Animal Drug Use; Order of Prohibition | The FDA is prohibiting the extralabel use of phenylbutazone animal and human drugs in female dairy cattle 20 months of age or older.The extralabel use presents a risk to the public health. February 28, 2003 -- 68 FR 9528 |
The FDA has determined that the extralabel use of phenylbutazone presents a risk to the public health. The FDA's conclusion is based on available toxicology data including data from the NTP Toxicology and Carcinogenesis Studies of Phenylbutazone (TR-367)and the NTP genotoxicity tests. | 50-33-9 |
| Notice | International Conference on Harmonisation; Draft Recommendations for the Revision of the Permitted Daily Exposures for Two Solvents,N-Methylpyrrolidone and Tetrahydrofuran. | The FDA is proposing a rule that would establish conditions under which over-the-counter drug products for the reduction or prevention of dental plaque and gingivitis are generally recognized as safe and effective and not misbranded. May 29, 2003 -- 68 FR 32232 |
The NTP 13-week Stannous Chloride studies were used to develop the existing safety factor for potential exposure to Stannous salts from use of a dentifrice containing stannous fluoride. (TR-231) | 7772-99-8 |
| Final Rule | Final Rule Declaring Dietary Supplements Containing Ephedrine Alkaloids Adulterated Because They Present an Unreasonable Risk | Final Rule Declairing 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 |
| 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 |
| Notice | Guidance for Industry: Labeling for Topically Applied Cosmetic Products Containing Alpha Hydroxy Acids as Ingredients; Availability | The Food and Drug Administration (FDA) is announcing the availability of a guidance document entitled "Guidance for Industry: Labeling for Topically Applied Cosmetic Products Containing Alpha Hydroxy Acids as Ingredients." The guidance recommends content for a labeling statement for cosmetic products containing alpha hydroxy acids (AHAs) as ingredients. January 10, 2005 -- 70 FR 1721 |
Publication of this guidance is an interim measure while FDA continues to review the data on the effects of AHA-containing products on skin sensitivity to UV radiation, including a photocarcinogenicity study by the National Toxicology Program's Center for Phototoxicology and recent studies published in peer-reviewed journals. FDA invites comments to continue to inform FDA of new studies when they become available. (TR-524) | 79-14-1 and 69-72-7 |
| Final Rule | Food Additives Permitted for Direct Addition to Food for Human Consumption; Acacia (Gum Arabic) | The Food and Drug Administration (FDA) is amending the food additive regulations to provide for the safe use of acacia (gum arabic) as a thickener, emulsifier, or stabilizer in alcoholic beverages at a maximum use level of 20 percent. This action is in response to a petition filed by Kerry, Inc. February 17, 2005 -- 70 FR 8032 |
FDA conducted literature searches that updated the information that had formed the basis of the Select Committee report. The agency reviewed toxicological data from a 1982 National Toxicology Program (NTP) report of 2-year carcinogenicity feeding studies on acacia in F344 rats and B6C3F1 mice. The agency evaluated the carcinogenicity of acacia and concluded that F344 rats and B6C3F1 mice consuming diets containing up to 5-percent acacia for 2 years showed no increased incidences of tumors at any site. (TR-227) | 9000-01-5 |
| Final Rule | Food Additives Permitted for Direct Addition to Food for Human Consumption; Synthetic Fatty Alcohols | The Food and Drug Administration (FDA) is amending the food additive regulations to provide for the safe use of n-octanol (n-octyl alcohol) produced by a new manufacturing process, the hydrodimerization of 1,3-butadiene. This action is in response to a petition filed by Kuraray International Corp. December 8, 2005 -- 70 FR 72906 |
The following references have been placed on display in the Division of Dockets Management (see ADDRESSES) and may be seen by interested persons between 9 a.m. and 4 p.m., Monday through Friday. "Toxicology and Carcinogenesis Studies of 1,3-Butadiene (CAS No. 106-99-0) in B6C3F1 Mice (Inhalation Studies)," National Toxicology Program (TR-434). | 106-99-0 |
| Proposed | Skin Bleaching Drug Products For Over-the-Counter Human Use; Proposed Rule | The Food and Drug Administration is issuing a notice of proposed rulemaking that would establish that over-the-counter (OTC) skin bleaching drug products are not generally recognized as safe and effective (GRASE) and are misbranded. FDA is also withdrawing the previous proposed rule on skin bleaching drug products for OTC human use, which was issued in the form of a tentative final monograph (TFM). FDA is issuing this proposed rule after considering new data and information on the safety of hydroquinone, the only active ingredient that had been proposed for inclusion in a monograph for these products. This proposal is part of FDA's ongoing review of OTC drug products. Further, upon issuance of a final rule, FDA intends to consider all skin bleaching drug products, whether currently marketed on a prescription or OTC basis, to be new drugs requiring an approved new drug application (NDA) for continued marketing. August 29, 2006 -- 71 FR 51146 |
Toxicology and carcinogenesis studies on orally administered hydroquinone conducted under the support of the National Toxicology Program (NTP) (Refs. 1 and 2) have indicated "some evidence" of carcinogenicity in male and female rats and in female mice. FDA's Center for Drug Evaluation and Research (CDER) Carcinogenicity Assessment Committee (CAC) has evaluated the design, results, and NTP interpretation of these studies, and concurs with the NTP's assessment. (TR-366) | 123-31-9 and 497-76-7 |
| Notice | FDA-Regulated Products that Contain Bisphenol-A; Request for Information | The Food and Drug Administration (FDA) is requesting assistance in the identification of types of FDA-regulated products that contain Bisphenol A (BPA), whether as a component of the product or its packaging, and any information relating to the leaching of BPA from the packaging to the product and/or from the product from the product following human administration. October 15, 2008 -- 73 FR 61135 |
On April 14, 2008, the National Toxicology Program (NTP) released a draft brief on BPA for public comment and peer review. The NTP draft brief raises concerns that exposure to BPA could be linked to developmental problems of the endocrine system in infants and young children. The NTP draft brief also contains an exposure estimate to BPA for infants and young children due to leaching of BPA to food from plastic baby bottles and the linings of certain baby food containers. NTP has subsequently released a final report on BPA on September 3, 2008.Bisphenol A Evaluation | 80-05-7 |
| Total Notices | 52 | |||
| Notice Type | Title | Summary of Notice | NTP Information Cited | CAS Number |
|---|---|---|---|---|
| Proposed Rule | Lead | MSHA proposed rule to revise standards for air quality and chemical substances in mines. August 29, 1989 -- 54 FR 35760 |
NTP recommendation that lead oxide and lead sulfide be ranked a high priority for acute toxicity studies cited in support of proposed lead exposure standard. | 1317-36-8 1314-87-0 |
| Proposed | Asbestos Exposure Limit | MSHA is proposing to revise their existing health standards for asbestos exposure at metal and nonmetal mines, surface coal mines, and surface areas of underground coal mines. The proposed rule would reduce the full-shift permissible exposure limit and the excursion limit for airborne asbestos fibers, and make several nonsubstantive changes to add clarity to the standard. Exposure to asbestos has been associated with lung and other cancers, mesotheliomas, and asbestosis. This proposed rule would help assure that fewer miners who work in an environment where asbestos is present
would suffer material impairment of health or functional capacity over their working lifetime. July 29, 2005 -- 70 FR 43950 |
There have been increasing numbers of studies on asbestos and its hazards over the past 40 years. These efforts encompass government, industry, and academia on a local, national, and international scale. Government agencies and scientific groups in the United States, such as the National Institute for Occupational Safety and Health (NIOSH), the Agency for Toxic Substances and Disease Registry (ATSDR), the American Conference of Governmental Industrial Hygienists (ACGIH), and the National Toxicology Program (NTP), have addressed issues involving carcinogens, such as asbestos. | 1332-21-4 |
| Final Rule | Diesel Particulate Matter Exposure of Underground Metal and Nonmetal Miners | This final rule revises the May 20, 2006 effective date of the diesel particulate matter (DPM) final concentration limit of 160 micrograms of total carbon (TC) per cubic meter of air (160TC ug/m3) promulgated in the 2001 final rule "Diesel Particulate Matter Exposure of Underground Metal and Nonmetal Miners," and published in the Federal Register on January 19, 2001 (66 FR 5706) and amended on September 19, 2005 (70 FR 55019). May 18, 2006 -- 71 FR 28924 |
In the 10th edition of its Report on Carcinogens, the National Toxicology Program (NTP) of the National Institutes of Health formally retained its designation of diesel exhaust particulates as "reasonably anticipated to be a human carcinogen." (U.S. Dept. of Health and Human Services, 2002).
(ROC). Although many commenters agreed that the adverse health effects associated with miners' exposure to DPM warranted an exposure limit, commenters from trade associations and industry continued to challenge the conclusions of the 2001 risk assessment. Discussions addressing this issue were summarized in the 2001 risk assessment and the 2005 update. As referenced in this section, the U.S. Environmental Protection Agency, World Health Organization, and the National Toxicology Program regard DPM exposure as adversely affecting human health. |
N/A |
| Total Notices | 3 | |||
| Notice Type | Title | Summary of Notice | NTP Information Cited | CAS Number |
|---|---|---|---|---|
| Notice | Ethylene Dibromide | OSHA NPRM to revise current occupational exposure standard to reduce PEL, restrict dermal exposure, etc. October 7, 1983 -- 48 FR 45956 |
NTP/NCI inhalation bioassay concluded that EDB was carcinogenic to rats. (TR-210) | 106-93-4 |
| Notice | Asbestos | OSHA emergency temporary standard to reduce occupational PEL. November 4, 1983 -- 48 FR 51086 |
NTP studies in which Chrysotile, Amosite, Tremolite, and Crocidolite in feed were administered to lab animals with no increased incidence of tumors. | 12001-28-4 12001-29-5 12172-73-5 14567-73-8 1332-21-4 |
| Notice | Hazard Communication | OSHA final rule setting final occupational safety and health standard requiring hazard assessment and communication to employees of chemical hazard information. November 25, 1983 -- 48 FR 53280 |
For purposes of hazard communication, OSHA defines a carcinogen as any substance found to be a confirmed or suspected carcinogen by NTP, IARC, or OSHA itself. | N/A |
| Other | Ethylene Oxide | OSHA final standard on occupational PEL. June 22, 1984 -- 49 FR 25734 |
NTP studies show significance of all malignancies rather than increases in only certain types of cancer, in calculating human risk. (TR-326) | 75-21-8 |
| Proposed Rule | Benzene | OSHA proposed rule on occupational exposure to benzene to reduce PEL from 10 ppm to 8-hr TWA to 1 ppm to reduce risk of leukemia and other adverse health consequences. December 10, 1985 -- 50 FR 50512 |
"NTP has demonstrated statistically significant, dose-dependent increase in tumors of multiple sites for both sexes of two species.." (TR-289) | 71-43-2 |
| Notice | 4,4'-Methylenedianiline (MDA) | OSHA notice responding to EPA referral of MDA under TSCA Section 9 and announcing determination that the risk described by EPA may be eliminated or reduced by a workplace standard. February 26, 1986 -- 51 FR 6748 |
"The most persuasive study has been conducted by the National Toxicology Program" in leading OSHA "to the conclusion that this chemical is carcinogenic in animals and may be carcinogenic to humans." (TR-248) | 13552-44-8 |
| Notice | 1,3-Butadiene | OSHA notice responding to EPA referral under TSCA Section 9 and announcing preliminary conclusion that current PEL should be revised. April 11, 1986 -- 51 FR 12526 |
"The magnitude of the carcinogenicity evidence in the NTP animal studies warrants regulatory action." (TR-288) | 106-99-0 |
| Final Rule | Asbestos, Tremolite, Anthrophyllite, and Actinolite | OSHA final rule amending standard for occupational exposure and establishing a PEL. June 20, 1986 -- 51 FR 22612 |
NTP studies involved oral administration of chrysotile, amosite, tremolite and crocidolite asbestos to lab animals. | 12001-28-4 14567-73-8 12172-73-5 |
| Other | 1,3-Butadiene | OSHA ANPR to reduce occupational exposure. October 1, 1986 -- 51 FR 35003 |
"OSHA has determined that the magnitude of the carcinogenicity evidence in the NTP animal study, almost 100% of the exposed animals developed tumors, warrants regulatory action." (TR-288) | 106-99-0 |
| Other | Methylene Chloride | OSHA ANPR to revise occupational health exposure standards. November 24, 1986 -- 51 FR 42257 |
"The NTP bioassays have provided clear evidence of carcinogenicity in female rats and in both sexes of mice." TR-306. | 75-09-2 |
| Final Rule | Benzene | OSHA final rule revising existing occupational standard to reduce PEL (Permissible Exposure Limit) from 10 ppm to 8-hr TWA (time weighted average) of 1 ppm and short-term exposure limit of 5 ppm. September 11, 1987 -- 52 FR 34460 |
NTP 2-year inhalation bioassay; TR-289 | 71-43-2 |
| Final Rule | Air Contaminants | OSHA final rule amending the air contaminants standard, including new table of Permissible Exposure Limits (PEL). January 19, 1989 -- 54 FR 2332 |
NTP research cited includes bioassay of perchloroethylene and propylene oxide. (TR-311) (TR-267) | 127-18-4 75-56-9 |
| Notice | Methylene Chloride (75-09-2) | OSHA agenda notice to planned NPRM setting new standard for occupational exposure. April 24, 1989 -- 54 FR 16873 |
This regulatory action is in response to a petition based on information from NTP and EPA. | 75-09-2 |
| Proposed Rule | 4,4'-Methylenedianiline (13552-44-8) | OSHA proposed rule to establish an 8-hour time-weighted average (TWA) of 10ppb, a short-term exposure limit (STEL) of 100PPB, and associated provisions. May 12, 1989 -- 54 FR 20672 |
The OSHA-established MDA Advisory Committee used the NTP study "as the principal basis for its carcinogenicity findings." (TR-248) | 13552-44-8 |
| Proposed Rule | Occupational Exposure to Methylene Chloride | Notice of informal public hearings concerning OSHA's proposal to modify the existing provisions for controlling employee exposure to methylene chloride. June 9, 1992 -- 57 FR 24438 |
OSHA based its preliminary estimate of human cancer risk on the NTP mouse study. (TR-306) | 75-09-2 |
| Proposed Rule | Air Contaminants | Health Effects of Substances to be Regulated June 12, 1992 -- 57 FR 26042 |
OSHA used data from several NTP studies. (TR-363) (TR-228) (TR-263) (TR-382) (TR-273) (TR-311) (TR-362) (TR-217) (TR-267) (TR-314) (TR-349) (TR-251) (TR-376) | 74-96-4 75-35-4 78-87-5 98-01-1 79-01-6 127-18-4 106-87-6 96-18-4 117-81-7 75-05-8 75-56-9 80-62-6 87-86-5 26471-62-5 106-92-3 |
| Final Rule | Occupational Exposure to Cadmium | OSHA publishes a new standard for occupational exposure to cadmium. September 14, 1992 -- 57 FR 42102 |
Clear evidence of carcinogenicity of cadmium in animals was based on NTP's definition of clear evidence of carcinogenicity from the Report of the NTP Ad Hoc Panel on Chemical Carcinogenesis Testing and Evaluation. | N/A |
| Final Rule | C.I. Pigment Violet #23 (Carbazole Violet), C.I. Pigment Blue #15, C.I. Pigment Green #7, and FD & C Red No. 40; Tolerance Exemptions | Incorporation into 29 CFD part 1915 of a comprehensive subpart Z which includes the toxic substance standards and certain related standards applicable to shipyards. July 1, 1993 -- 58 FR 35512 |
Annual Report on Carcinogens published by the NTP is used by OSHA in identifying toxic substances to be regulated. | N/A |
| Final Rule | Hazard Communication | Requirement of employers to establish hazard communication programs to transmit information on the hazards of chemicals to their employees by means of labels on containers, material safety data sheets, and training programs. February 9, 1994 -- 59 FR 6126 |
Annual Report on Carcinogens published by the NTP is used by OSHA in identifying toxic substances to be regulated. | N/A |
| Proposed Rule | Respiratory Protection | OSHA is proposing to modify its existing standards on respiratory protection so that employers will provide effective protection for employees who wear respirators. agents include saccharin and di-2-ethylhexyl phthalate (DEHP). November 15, 1994 -- 59 FR 58884 |
One of the respiratory protection testing agents was di-2-ethylhexyl phthalate (DEHP). OSHA cites positive carcinogenic findings of DEHP in two rodent species by NTP as sufficient evidence to preclude its use in respirator quantitative fit testing. TR-217 | 117-81-7 |
| Proposed Rule | Dichlorvos; Notice of Preliminary Determination to Cancel Certain Registrations and Draft Notice of Intent to Cancel | Proposed Rule: OSHA reopened the record for proposed revisions of the 1,3-Butadiene (BD) standard to solicit public comment on a joint labor/industry agreement recommending that OSHA reduce the permissible exposure limits and expand on some provisions that should be included in the standard. March 8, 1996 -- 61 FR 9381 |
Representatives of major unions and industry groups submitted a voluntary agreement based in part, on new NTP 1,3-Butadiene data (TR-434). The recommended regulatory requirements can lead to lower and less frequent exposures for employees who work with or near BD. | 106-99-0 |
| Notice | Supplement to California State Plan; Approval | OSHA approves, subject to certain conditions, the California Hazard Communication Standard, including Proposition 65 -- the California Safe Drinking Water and Toxic Enforcement Act. June 6, 1997 -- 62 FR 31159 |
In accordance with Proposition 65, California annually publishes a list of chemicals known to cause cancer or reproductive toxicity. This list includes chemicals identified as carcinogens by IARC and the NTP. | N/A |
| Final Rule | Air Contaminants | OSHA notice providing index to Jan. 19, 1989 final rule and list of references relied upon for health effects evaluations in rule. March 28, 2000 -- 54 FR 12792 |
NTP references cited include TR-306, TR-228, TR-263, TR-273, ;TR-311, TR-259, TR-251. | 78-87-5 127-18-4 140-88-5 26471-62-5 75-09-2 75-35-4 79-01-6 |
| Final Rule | Occupational Exposure to 4,4'Methylenedianiline (MDA) | OSHA is promulgating new standards regulating exposure to MDA. August 10, 2000 -- 57 FR 35630 |
The Committee determined that the tumors found in the NTP study did not result from exposure to MDA. (TR-248) | 13552-44-8 |
| 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 4, 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 |
| Notice | Notice of Availability of the Regulatory Flexibility Act Review of the Occupational Health Standard for Ethylene Oxide | The Occupational Safety and Health Administration (OSHA) has conducted a review of its Ethylene Oxide (EtO) Standard pursuant to section 610 of the Regulatory Flexibility Act and section 5 of Executive Order 12866 on Regulatory Planning and Review. April 22, 2005 -- 70 FR 20807 |
There is a continued need for the rule. Workers exposed to EtO in a range of industries would continue to be at risk of cancer, genetic changes and other adverse health effects, without the standard. Since the standard was developed, the International Agency for Research on Cancer reclassified EtO as a known human carcinogen and the National Toxicology program reclassified EtO as a one "known to be a human carcinogen."
(TR-326)(ROC) |
75-21-8 |
| Final Rule | Occupational Exposure to Hexavalent Chromium | The Occupational Safety and Health Administration (OSHA) is amending the existing standard which limits occupational exposure to hexavalent chromium (Cr(VI)). OSHA has determined based upon the best evidence currently available that at the current permissible exposure limit (PEL) for Cr(VI), workers face a significant risk to material impairment of their health. February 28, 2006 -- 71 FR 10100 |
The National Toxicology Program (NTP) conducted an extensive multigenerational reproductive assessment by continuous breeding where the chromate was administered in the diet. The assessment yielded negative results. Animal inhalation studies were also negative. Thus, it cannot be concluded that Cr(VI) is a reproductive toxin for normal working situations. (Hexavalent chromium) | 18540-29-9 |
| Total Notices | 27 | |||
| Notice Type | Title | Summary of Notice | NTP Information Cited | CAS Number |
|---|---|---|---|---|
| Final Rule | Irradiation of Pork | USDA final rule to permit gamma radiation to control Trichinella Spiralis. January 15, 1986 -- 51 FR 1769 |
NTP review of histopathology data on mice fed irradiated chicken, requested by FDA, concluded that data did not demonstrate a carcinogenic response. | N/A |
| Total Notices | 1 | |||
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