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Regulatory Actions for Year 1986

Year Agency Title CASRN
1986 EPA
2-Ethylhexanol

EPA proposed rule on testing under TSCA Section 4.

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

  • Type: Proposed Rule
  • December 19, 1986
  • 51 FR 45487
104-76-7
1986 FDA
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.

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This regulation, based on a deminimus interpretation of the Delaney Clause was revoked following a federal court ruling.

  • Type: Final Rule
  • December 05, 1986
  • 51 FR 43877
5160-02-1
1986 OSHA
Methylene Chloride

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.

  • Type: Other
  • November 24, 1986
  • 51 FR 42257
75-09-2
1986 FDA
FD& C Yellow No. 6

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)

  • Type: Final Rule
  • November 19, 1986
  • 51 FR 41765
2783-94-0
1986 EPA
2-Ethylhexanoic Acid

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.

  • Type: Final Rule
  • November 06, 1986
  • 51 FR 40318
149-57-5
1986 EPA
1,3-Dichloropropene

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

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

  • Type: Notice
  • October 08, 1986
  • 51 FR 36160
542-75-6
1986 OSHA
1,3-Butadiene

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)

  • Type: Other
  • October 01, 1986
  • 51 FR 35003
106-99-0
1986 EPA
Nickel Subsulfide and Nickel Carbonyl

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)

  • Type: Notice
  • September 25, 1986
  • 51 FR 34135
10101-97-0
1313-99-1
12035-72-2
1986 EPA
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.

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

  • Type: Other
  • September 24, 1986
  • 51 FR 33992
1986 EPA
Bisphenol A

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.

  • Type: Final Rule
  • September 18, 1986
  • 51 FR 33047
80-05-7
1986 EPA
Dioxin-containing wastes

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.

  • Type: Other
  • September 15, 1986
  • 51 FR 32670
57653-85-7
1986 EPA
1,2-Dichloropropane

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.

  • Type: Final Rule
  • September 09, 1986
  • 51 FR 32079
78-87-5
1986 EPA
Pentachloroethane

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.

  • Type: Final Rule
  • September 09, 1986
  • 51 FR 32077
76-01-7
1986 EPA
1,1-Dichloroethylene

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

  • Type: Proposed Rule
  • August 12, 1986
  • 51 FR 28840
75-35-4
1986 FDA
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.

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.

  • Type: Final Rule
  • August 07, 1986
  • 51 FR 28331
1986 EPA
11-Aminoundecanoic Acid

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.

  • Type: Proposed Rule
  • July 22, 1986
  • 51 FR 26273
2432-99-7
1986 EPA
Toluenediamines

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)

  • Type: Notice
  • July 10, 1986
  • 51 FR 25070
95-80-7
1986 EPA
Chlorinated Benzenes

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)

  • Type: Final Rule
  • July 08, 1986
  • 51 FR 24657
106-46-7
95-50-1
95-94-3
1986 EPA
8 Polybrominated Biphenyls (PBB's) and Tris

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.

  • Type: Proposed Rule
  • July 07, 1986
  • 51 FR 24555
67774-32-7
1986 OSHA
Asbestos, Tremolite, Anthrophyllite, and Actinolite

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.

  • Type: Final Rule
  • June 20, 1986
  • 51 FR 22612
12001-28-4
14567-73-8
12172-73-5
1986 EPA
Methylcyclopentane and Commercial Hexane

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)

  • Type: Final Rule
  • May 15, 1986
  • 51 FR 17854
110-54-3
96-37-7
1986 EPA
Cresols

EPA final rule to require testing under TSCA Section 4.

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

  • Type: Final Rule
  • April 28, 1986
  • 51 FR 15771
1319-77-3
1986 OSHA
1,3-Butadiene

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)

  • Type: Notice
  • April 11, 1986
  • 51 FR 12526
106-99-0
1986 EPA
Pentachloroethane

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.

  • Type: Proposed Rule
  • March 24, 1986
  • 51 FR 10024
76-01-7
1986 EPA
Perchloroethylene

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.

  • Type: Notice
  • March 05, 1986
  • 51 FR 7718
127-18-4
1986 EPA
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.

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

  • Type: Notice
  • February 27, 1986
  • 51 FR 6929
75-12-7
1986 OSHA
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.

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)

  • Type: Notice
  • February 26, 1986
  • 51 FR 06748
13552-44-8
1986 USDA
Irradiation of Pork

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.

  • Type: Final Rule
  • January 15, 1986
  • 51 FR 1769