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Regulatory Actions for Year 1998

Year Agency Title CASRN
1998 FDA
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.

NTP Information Cited
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

  • Type: Final Rule
  • November 03, 1998
  • 63 FR 59213
1998 OEHHA
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

NTP Information Cited
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.

  • Type: Notice
  • May 15, 1998
  • Proposition 65
88-72-2
1998 OEHHA
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

NTP Information Cited
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.

  • Type: Notice
  • May 15, 1998
  • Proposition 65
612-83-9
1998 OEHHA
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

NTP Information Cited
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.

  • Type: Notice
  • May 15, 1998
  • Proposition 65
21739-91-3
1998 OEHHA
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

NTP Information Cited
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.

  • Type: Notice
  • May 15, 1998
  • Proposition 65
598-55-0
1998 OEHHA
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

NTP Information Cited
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.

  • Type: Notice
  • May 15, 1998
  • Proposition 65
77-09-8
1998 OEHHA
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

NTP Information Cited
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.

  • Type: Notice
  • May 15, 1998
  • Proposition 65
20265-96-7
1998 OEHHA
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

NTP Information Cited
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.

  • Type: Notice
  • May 15, 1998
  • Proposition 65
389-08-2
1998 OEHHA
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

NTP Information Cited
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.

  • Type: Notice
  • May 15, 1998
  • Proposition 65
842-07-9
1998 OEHHA
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

NTP Information Cited
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.

  • Type: Notice
  • May 15, 1998
  • Proposition 65
599-79-1
1998 EPA
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.

NTP Information Cited
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.

  • Type: Final Rule
  • May 13, 1998
  • 63 FR 26481
20265-96-7
1998 EPA
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.

NTP Information Cited
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.

  • Type: Final Rule
  • May 04, 1998
  • 63 FR 24596
88-06-2
106-93-4
107-06-2
1998 EPA
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.

NTP Information Cited
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).

  • Type: Notice
  • March 02, 1998
  • 63 FR 10274
74-83-9