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Regulatory Actions for Year 1986

Environmental Protection Agency (EPA)

Notice Type Title Summary of Notice NTP Information Cited CASRN
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
Final Rule 2-Ethylhexanoic Acid EPA final rule to require testing under TSCA Section 4.

November 06, 1986 -- 51 FR 40318 		Reference to NTP nomination of compounds containing the 2-ethylhexyl moiety for mutagenicity testing. 149-57-5
Notice 1,3-Dichloropropene EPA notice of special review of pesticides containing 1,3-dichloropropene.

October 08, 1986 -- 51 FR 36160 		NTP gavage study showed clear evidence of carcinogenicity. TR-269. 542-75-6
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
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.
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 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 1,2-Dichloropropane EPA final rule to require testing under TSCS Section 4.

September 09, 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 09, 1986 -- 51 FR 32077 		NTP bioassay demonstrated limited evidence of carcinogenicity in lab animals. TR-232. 76-01-7
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
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
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
Final Rule Chlorinated Benzenes EPA final rule to require testing under TSCA Section 4.

July 08, 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
Proposed Rule 8 Polybrominated Biphenyls (PBB's) and Tris EPA proposed rule promulgating a significant new use rule under TSCA Section 5.

July 07, 1986 -- 51 FR 24555 		Reference to NTP bioassay of polybrominated biphenyl mixture. TR-244. 67774-32-7
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
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
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
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 05, 1986 -- 51 FR 7718 		NTP toxicology and carcinogenesis studies in rats and mice. TR-311. 127-18-4
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
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Food and Drug Administration (FDA)

Notice Type Title Summary of Notice NTP Information Cited CASRN
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 05, 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 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 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 07, 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.
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Occupational Safety and Health Administration (OSHA)

Notice Type Title Summary of Notice NTP Information Cited CASRN
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
Other 1,3-Butadiene OSHA ANPR to reduce occupational exposure.

October 01, 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
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
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
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 06748 		"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
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United States Department of Agriculture (USDA)

Notice Type Title Summary of Notice NTP Information Cited CASRN
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.
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