Regulatory Actions for Year 1986

EPA proposed rule on testing under TSCA Section 4.

NTP Information Cited
Reference to study of 2-Ethyl-1-hexanol supported by NIEHS.

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.

NTP Information Cited
This regulation, based on a deminimus interpretation of the Delaney Clause was revoked following a federal court ruling.

OSHA ANPR to revise occupational health exposure standards.

NTP Information Cited
"The NTP bioassays have provided clear evidence of carcinogenicity in female rats and in both sexes of mice." TR-306.

FDA final rule permanently listing FD Yellow No. 6 for use in food, drugs, and cosmetics.

NTP Information Cited
"With the exception of the 1981 NCI/NTP bioassays that were done, the agency considered past studies as inadequate.." (TR-208)

EPA final rule to require testing under TSCA Section 4.

NTP Information Cited
Reference to NTP nomination of compounds containing the 2-ethylhexyl moiety for mutagenicity testing.

EPA notice of special review of pesticides containing 1,3-dichloropropene.

NTP Information Cited
NTP gavage study showed clear evidence of carcinogenicity. TR-269.

OSHA ANPR to reduce occupational exposure.

NTP Information Cited
"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)

EPA notice of determination that no Federal regulation is warranted at this time under CAA.

NTP Information Cited
NTP and NIEHS are currently conducting animal bioassays of selected nickel compounds. (TR-454) (TR-451) (TR-453)

EPA issuance of guidelines for carcinogen risk assessment, mutagenicity risk assessment, health risk assessment of chemical mixtures, and health assessment of suspect developmental toxicants.

NTP Information Cited
Each of these 4 EPA guidelines makes reference to NTP studies.

EPA final rule to require a 90-day inhalation subchronic toxicity study with particular emphasis on pulmonary effects, under TSCA Section 4.

NTP Information Cited
NTP oral gavage bioassay provides needed data to evaluate subchronic toxicity of PBA. TR-215.

EPA denial of petition to amend rule listing certain dioxin-containing wastes as acute hazardous wastes.

NTP Information Cited
NTP bioassay study of HXCDD referred to in docket. TR-198.

EPA final rule to require testing under TSCS Section 4.

NTP Information Cited
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.

EPA final rule promulgating a significant new use rule under TSCA Section 5.

NTP Information Cited
NTP bioassay demonstrated limited evidence of carcinogenicity in lab animals. TR-232.

EPA proposed rule to require testing under TSCA Section 4.

NTP Information Cited
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

FDA final rule permanently listing D Orange No. 17 as a color additive for use in externally applied drugs and cosmetics.

NTP Information Cited
NTP publication cited reporting 50% of 86 compounds tested by NTP between 7/81-7/84 were determined to induce some carcinogenic effect.

EPA proposed rule promulgating a significant new use rule under TSCA Section 5.

NTP Information Cited
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.

EPA notice of termination of investigation of occupational exposure in light of evidence of carcinogenicity.

NTP Information Cited
Bioassays conducted under the NTP have demonstrated that 2,4-Toluenediamine causes cancer in lab animals. (TR-162)

EPA final rule to require testing under TSCA Section 4.

NTP Information Cited
NTP studies of 1,2,4,5-TCB, 1,2-DCB, & 1,4-DCB. (TR-319) (TR-255)

EPA proposed rule promulgating a significant new use rule under TSCA Section 5.

NTP Information Cited
Reference to NTP bioassay of polybrominated biphenyl mixture. TR-244.

OSHA final rule amending standard for occupational exposure and establishing a PEL.

NTP Information Cited
NTP studies involved oral administration of chrysotile, amosite, tremolite and crocidolite asbestos to lab animals.

EPA proposed rule to require testing under TSCA Section 4.

NTP Information Cited
NTP is conducting a subchronic inhalation toxicity test and is supporting reproductive and developmental toxicity testing. (TOX-02)

EPA final rule to require testing under TSCA Section 4.

NTP Information Cited
NTP is planning range-finding and subchronic studies. (TOX-09)

OSHA notice responding to EPA referral under TSCA Section 9 and announcing preliminary conclusion that current PEL should be revised.

NTP Information Cited
"The magnitude of the carcinogenicity evidence in the NTP animal studies warrants regulatory action." (TR-288)

EPA proposed rule promulgating a significant new use rule under TSCA Section 5. (Final rule published 9/9/86.)

NTP Information Cited
NTP bioassay demonstrated evidence of carcinogenicity in both sexes of rats and mice. TR-232.

EPA correction of previous FR notice to assess perchloroethylene as a potentially toxic air pollutant under the Clean Air Act Section 112.

NTP Information Cited
NTP toxicology and carcinogenesis studies in rats and mice. TR-311.

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.

NTP Information Cited
NTP testing of formamide over 5 doses in 4 strains of salmonella; no indication of mutagenic activity seen.

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.

NTP Information Cited
"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)

USDA final rule to permit gamma radiation to control Trichinella Spiralis.

NTP Information Cited
NTP review of histopathology data on mice fed irradiated chicken, requested by FDA, concluded that data did not demonstrate a carcinogenic response.