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Regulatory Actions for Year 1997

Year Agency Title CASRN
1997 FDA
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).

NTP Information Cited
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.

  • Type: Proposed Rule
  • September 02, 1997
  • 62 FR 46223
77-09-8
1997 OEHHA
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

NTP Information Cited
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.

  • Type: Notice
  • August 15, 1997
  • Proposition 65
2429-74-5
1997 OEHHA
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

NTP Information Cited
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.

  • Type: Notice
  • August 15, 1997
  • Proposition 65
81-49-2
1997 OEHHA
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

NTP Information Cited
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.

  • Type: Notice
  • August 15, 1997
  • Proposition 65
28407-37-6
1997 OSHA
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.

NTP Information Cited
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.

  • Type: Notice
  • June 06, 1997
  • 62 FR 31159
N/A
1997 EPA
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.

NTP Information Cited
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.

  • Type: Proposed Rule
  • May 07, 1997
  • 62 FR 24887
1997 OEHHA
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

NTP Information Cited
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.

  • Type: Notice
  • May 01, 1997
  • Proposition 65
75-52-5
1997 OEHHA
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

NTP Information Cited
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.

  • Type: Notice
  • May 01, 1997
  • Proposition 65
75-02-5
1997 EPA
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.

NTP Information Cited
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.

  • Type: Final Rule
  • January 15, 1997
  • 62 FR 2011
75-09-2
1997 EPA
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.

NTP Information Cited
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).

  • Type: Proposed Rule
  • January 03, 1997
  • 62 FR 366
10326-27-9