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Regulatory Actions for Year 1989


Environmental Protection Agency (EPA)

Notice Type Title Summary of Notice NTP Information Cited CASRN
Notice Ethylene Bisdthiocarbamate (EBDC) Pesticides EPA Notice of Preliminary Determination to propose cancellation of certain registrations of EBDC products and propose modifications of registrations not cancelled.

December 20, 1989 -- 54 FR 52158
NTP carcinogenicity studies of ethylene thiourea (ETU) (CAS: 96-45-7), a common contaminant, metabolite, and degradation product of EBDCs. (TR-388) 96-45-7
Notice Inert Ingredients in Pesticides EPA notice for revision of lists of inert ingredients of toxicological concern.

November 22, 1989 -- 54 FR 48314
Based on an NTP bioassay di-(2-ethylhexyl)adipate was moved to List 1 ("Inerts of Toxicological Concern") from List 3 ("Inerts of Unknown Toxicity") (TR-212) 103-23-1
Final Rule Methyl Ethyl Ketoxime (96-29-7) EPA final rule under TSCA 4 to require testing for oncogenicity, mutagenicity, developmental toxicity, reproductive toxicity, neurotoxicity, and pharmacokinetics.

September 13, 1989 -- 54 FR 37799
Reference to NTP research on MEKA and other NTP studies relevant to the testing requirements. 96-29-7
Final Rule Reportable Quantities: 1,4-dioxane, 2-ethoxyethanol, ethylene oxide, 2-nitropropane, perchloroethylene, and saccharin. EPA final rule adjusting the reportable quantities (RQ) of these six substances; hazardous substance releases in quantities equal to or greater than their RQ's must be reported to the National Response Center.

August 14, 1989 -- 54 FR 33418
"The NTP annual reports (on carcinogens) and IARC monographs are used only as an initial screen for substances to be evaluated for potential carcinogenicity by the Agency. EPA follows the procedures set out in its Guidelines for Carcinogen Risk Assessment to make this determination." 75-21-8
110-80-5
79-46-9
123-91-1
81-07-2
Final Rule Asbestos EPA final rule under TSCA 6 to prohibit future manufacture, importation, processing, and distribution in commerce of asbestos in almost all products.

July 12, 1989 -- 54 FR 29460
Reference to NTP toxicology and carcinogenesis studies of chrysotile asbestos. (TR-246) (TR-295) 12001-29-5
Final Rule Reportable quantities: Methyl Isocyanate (624-83-9), Aluminum Thiosulfate, and 258 other substances EPA final rule retaining statutory RQ for MIC, delisting ammonium thiosulfate, and adjusting the RQ's of 258 hazardous substances.

July 12, 1989 -- 54 FR 33426
Use of NTP report on carcinogens used as an initial screen for substances to be evaluated for potential carcinogenicity. MIC studies documented in EHP volume 72 utilized in decision to retain MIC. 624-83-9
Proposed Rule Drinking Water EPA proposed rule on maximum contaminant level goals and National Primary Drinking Water Regulations for 30 synthetic organic chemicals and 8 inorganic chemicals.

June 23, 1989 -- 54 FR 22062
NTP bioassays of chrysotile asbestos, 1,2-dichloropropane, monochlorobenzene, pentachlorophenol,styrene, tetrachloroethylene, and xylenes are cited. (TR-327) (TR-263) (TR-185) (TR-311) (TR-349) (TR-261) (TR-295) 78-87-5
100-42-5
87-86-5
108-90-7
12001-29-5
127-18-4
1330-20-7
Proposed Rule Copper Phthalocyanine Pigments EPA proposed rule to exempt Pigments Blue 15, Green 7, and Green 36 from SARA 313 release reporting requirements.

May 15, 1989 -- 54 FR 20866
NTP oral studies of PB-15 and PG-7 showed no signs of compound-related toxicity. 147-14-8
1328-53-6
Proposed Rule Dinitrobenzenes, Allyl Alcohol, Diethylamine, 2,3-Dichloropropene, Isosafrole, Creosote, Dinitrotoluene, Toluenediisocyanate EPA proposed rule to add these chemicals to list of chemicals for which release reporting is required under SARA Section 313.

April 21, 1989 -- 54 FR 16138
NTP Annual Report on Carcinogens is one of the 4 data sources used by EPA in making carcinogenic evaluations of Section 313 determinations. 121-14-2
26471-62-5
109-89-7
8021-39-4
Final Rule Glycol Ethers EPA final rule on enforceable testing consent order.

April 04, 1989 -- 54 FR 13470
References to NTP studies of ethylene glycol monomethyl ether, 2-ethoxyethanol, and ethylene glycol monobutyl ether. 109-86-4
110-80-5
111-76-2
Notice Captan EPA notice of intent to cancel registrations.

February 24, 1989 -- 54 FR 8116
Rationale for combining organ sites and tumor sites in categorizing captan as a probable human carcinogen was based on NTP list of acceptable organ combinations. (TR-015) 133-06-2

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Food and Drug Administration (FDA)

Notice Type Title Summary of Notice NTP Information Cited CASRN
Final Rule 4,4'-Diphenylmethanediamine FDA final rule amending food additive regulations to allow use of polyamide-imide resins in articles which come into contact with food.

October 23, 1989 -- 54 FR 43168
Data from NTP carcinogenesis bioassay used to estimate upper-bound level of lifetime risk from proposed use of 4,4'-diiphenylmethanediamine.
Final Rule Methylene Chloride (75-09-2) FDA final rule banning use of methylene chloride as an ingredient of cosmetic products.

June 29, 1989 -- 54 FR 27328
NTP concluded with respect to their inhalation study on methylene chloride that there was clear evidence of carcinogenicity in mice and female rats and some evidence of carcinogenicity in male rats. 75-09-2

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Mine Safety and Health Administration (MSHA)

Notice Type Title Summary of Notice NTP Information Cited CASRN
Proposed Rule Lead MSHA proposed rule to revise standards for air quality and chemical substances in mines.

August 29, 1989 -- 54 FR 35760
NTP recommendation that lead oxide and lead sulfide be ranked a high priority for acute toxicity studies cited in support of proposed lead exposure standard. 1317-36-8
1314-87-0

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Occupational Safety and Health Administration (OSHA)

Notice Type Title Summary of Notice NTP Information Cited CASRN
Proposed Rule 4,4'-Methylenedianiline (13552-44-8) OSHA proposed rule to establish an 8-hour time-weighted average (TWA) of 10ppb, a short-term exposure limit (STEL) of 100PPB, and associated provisions.

May 12, 1989 -- 54 FR 20672
The OSHA-established MDA Advisory Committee used the NTP study "as the principal basis for its carcinogenicity findings." (TR-248) 13552-44-8
Notice Methylene Chloride (75-09-2) OSHA agenda notice to planned NPRM setting new standard for occupational exposure.

April 24, 1989 -- 54 FR 16873
This regulatory action is in response to a petition based on information from NTP and EPA. 75-09-2
Final Rule Air Contaminants OSHA final rule amending the air contaminants standard, including new table of Permissible Exposure Limits (PEL).

January 19, 1989 -- 54 FR 2332
NTP research cited includes bioassay of perchloroethylene and propylene oxide. (TR-311) (TR-267) 127-18-4
75-56-9

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