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Regulatory Actions for Year 1994


Environmental Protection Agency (EPA)

Notice Type Title Summary of Notice NTP Information Cited CASRN
Final Rule Addition of Certain Chemicals; Toxic Chemical Release Reporting; Community Right-to-Know EPA is taking this action pursuant to its authority to add to the list those chemicals and chemical categories that meet the EPCRA section 313(d)(2) criteria for addition to the list of toxic chemicals.

November 30, 1994 -- 59 FR 61432
Long-chain chlorinated paraffins have not been classified as "probable human carcinogens" by NTP or IARC and the NTP bioassay (TR-305) showed insufficient evidence. Therefore the EPA concludes that there is insufficient evidence to list long-chain chlorinated paraffins on the EPCRA section 313 list. 108171-27-3
Proposed Rule Asbestos Worker Protection; Asbestos-Containing Materials in Schools; Proposed Amendment The proposed rule would generally extend the coverage provided under the 1986 OSHA Asbestos Standard for Construction to State and local government employees who are not covered by OSHA- or EPA-approved State plans. It also proposes to extend coverage provided under the OSHA Asbestos Standard for General Industry for automotive brake and clutch repair.

November 01, 1994 -- 59 FR 54746
The EPA classifies asbestos as a Group A carcinogen as cited in the NTP's 7th Annual Report on Carcinogens. (TR-280) (TR-279) (TR-277) (TR-295) 12001-28-4
12172-73-5
14567-73-8
12001-29-5
Proposed Rule Drinking Water; National Primary Drinking Water Regulations: Disinfectants and Disinfection Byproducts Includes establishment of maximum residual disinfectant level goals (MRDLGs) for chlorine, chloramines, and chlorine dioxide and maximum contaminant level goals (MCLGs) for bromodichloromethane, dibromochloromethane, and bromoform.

July 29, 1994 -- 59 FR 38668
Data from the NTP toxicology and carcinogenesis studies of bromodichloromethane (TR-321), chlorinated and chloraminated water (TR-392), bromoform (TR-350), and dibromochloromethane (TR-282) were used as part of the evaluation to set maximum residual disinfectant level goals for these substances. 75-25-2
75-27-4
124-48-1
CHLORWATERMX
Notice Thirty-Fourth Report of the TSCA Interagency Testing Committee to the Administrator: Receipt of Report and Request for Comments Receipt of report of the TSCA Interagency Testing Committee to the Administrator. The ITC revised the Priority Testing List including the removal of eight chemicals from the List.

July 13, 1994 -- 59 FR 35720
The negative results of the NTP toxicology and carcinogenesis study of the structurally-related N-phenyl-2-napththylamine (TR-333) was used by the ITC in developing its rationale for removing N-phenyl-1-napththylamine from the List. 135-88-6
Proposed Rule Pesticides; Proposed Rule Revoking Certain Food Regulations Revocation of certain food additive regulations for several pesticides which EPA has determined "induce cancer" within the meaning of the Delaney Clause of section 409 of the Federal Food, Drug and Cosmetic Act.

July 01, 1994 -- 59 FR 33941
NTP toxicology and carcinogenesis study of ethylene oxide (TR-326) is cited as one of the studies used for conclusions that ethylene oxide induces cancer in animals. 75-21-8
Final Rule Fuels and Fuel Additives Registration Regulations Establishment of new requirements for the registration of designated fuels and fuel additives as authorized by sections of the Clean Air Act.

June 27, 1994 -- 59 FR 33042
NTP 13-week inhalation study of N-Hexane in B6C3F1 mice is cited as a reference for the neuropathology assessment. (TOX-02) 110-54-3
Final Rule Dicofol; Revocation of Food Additive Tolerance Revocation of the food additive tolerance for residues of the pesticide dicofol in or on dried tea.

March 09, 1994 -- 59 FR 10993
Data from the NTP toxicology and carcinogenesis study of dicofol (TR-90) showed a statistically significant increase of hepatocellular adenomas and combined hepatocellular adenomas and carcinomas in male mice (B6C3F1) at two doses tested.
115-32-2
Proposed Rule d_Limonene; Tolerance Exemption Exemption from the requirement of a tolerance be established for residues of d-limonene when used as an inert ingredient in pesticide formulations applied to growing crops or raw agricultural commodities after harvest.

February 23, 1994 -- 59 FR 8581
The NTP toxicology and carcinogenesis study of d-Limonene showed no carcinogenic activity in female rats and mice and in male mice. Clear evidence of kidney-associated carcinogenic activity was noted in male rats. However, the NTP concluded that the male rat kidney carcinogenicity is not predictive of mammalian carcinogenicity. (TR-347) 5989-27-5
Final Rule Cold, Cough, Allergy, Bronchodilator, and Antiasthmatic Drug Products for Over-the Counter Human Use; Amendment of Final Monograph of OTC Antihistamine Drug Products Establishment of conditions under which over-the-counter antihistamine drug products are generally recognized as safe and effective and not misbranded. Dec. 9, 1992. Amendment of final rule to include doxylamine succinate.

January 28, 1994 -- 59 FR 4216
Data from the NTP toxicology and carcinogenesis study on pyrilamine (TRs 408, 409) was used to determine that pyrilamine maleate is safe for OTC use. The results of an NCTR-toxicology and carcinogenesis study of doxylamine succinate conducted under the auspices of the NTP were used in developing a talk paper concerning the NCTR-findings in animals to inform consumers of these data and the uncertainty of their relevance to humans. 469-21-6
91-84-9
Final Rule Addition of Certain Chemicals; Toxic Chemical Release Reporting; Community Right-to-Know Addition of 313 chemicals and chemical categories to the list of toxic chemicals required to be reported on under section 313 of the Emergency Planning and Community Right-to-Know Act of 1986 and section 6607 of the Pollution Prevention Act of 1990.

January 12, 1994 -- 59 FR 1788
EPA considered chemicals designated as possible, probable, or known carcinogens in the Monographs of IARC and the 6th Annual Report on Carcinogens published by the NTP. Also, used results of the NTP toxicology and carcinogenesis studies of C.I. Acid Red 114 (TR-405), C.I. Direct Blue 218 (TR-430), Chlorendic acid (TR-304), 3-Chloro-2-methyl-1-propene (TR-300), Diglycidyl resorcinol ether, (TR-257), 3,3-Dimethoxybenzidine dihydrochloride (TR-372), 3,3-Dimethylbenzidine dihydrochloride (TR-390), and 5,5-Diphenylhydantoin (phenytoin) (TR-404). 115-28-6
57-41-0
28407-37-6
6459-94-5
101-90-6
563-47-3
20325-40-0
612-82-8

Food and Drug Administration (FDA)

Notice Type Title Summary of Notice NTP Information Cited CASRN
Final Rule Food Additives Permitted for Direct Addition to Food for Human Consumption; Acesulfame Potassium Methylene chloride is used as a solvent in the initial step in the manufacturing process of acesulfame potassium and may be present as an impurity in the additive. The FDA used risk assessment procedures to estimate the upper-bound limit of risk presented by methylene chloride.

December 01, 1994 -- 59 FR 61538
The FDA used data from the NTP bioassay on methylene chloride to calculate the potency, or unit risk, from exposure to this chemical. TR-306 75-09-2
Notice International Conference on Harmonisation; Draft Guideline on Specific Aspects of Regulatory Genotoxicity Tests; Availability Notification of publication of draft guideline "Notes for Guidance on Specific Aspects of Regulatory Genotoxicity Tests" to provide guidance on genotoxicity testing.

September 22, 1994 -- 59 FR 48734
The test battery approach is designed to reduce the risk of false negative results. However, genotoxicity test batteries as described will only detect carcinogens that act primarily via a mechanism involving direct genetic damage. According to results of the NTP (Haseman, et al, 1990), approximately 15 percent of carcinogens are not detected by the commonly used batteries of genotoxicity tests. N/A
Final Rule Secondary Direct Food Additives Permitted in Food for Human Consumption: Cellulose Triacetate Amendment of food additive regulations to provide for the safe use of cellulose triacetate as an immobilizing agent for lactase for use in reducing the lactose content of milk.

July 20, 1994 -- 59 FR 36935
Data from the NTP toxicology and carcinogenesis study of dichloromethane (TR-306) was used to calculate the risk from exposure to dichloromethane as an impurity in cellulose triacetate. 75-09-2
Proposed Rule Oral Health Care Drug Products for Over-the-Counter Human Use; Tentative Final Monograph for Oral Antiseptic Drug Products Notification of proposed rulemaking in the form of a tentative final monograph that would establish conditions under which over-the-counter oral antiseptic drug products are generally recognized as safe and effective and not misbranded.

February 09, 1994 -- 59 FR 6084
The FDA noted that benzethonium chloride is currently being evaluated for carcinogenic potential by the NTP. The agency also nominated gentian violet for study by the NTP after reviewing the available data and deciding that a definitive conclusion regarding its carcinogenic activity could not be reached. (TR-438) 121-54-0
Final Rule Food Additives Permitted for Direct Addition to Food for Human Consumption; Dimethyl Dicarbonate Amendment to the food additive regulations to provide for the safe use of dimethyl dicarbonate as a yeast inhibitor in dealcoholized and low alcohol wines, Jan 26, 1993, and in ready-to-drink tea beverages.

February 04, 1994 -- 59 FR 5317
NTP toxicology and carcinogenesis study on methyl carbamate (TR-328) was used to estimate the human cancer risk from the potential exposure to methyl carbamate stemming from the proposed use of dimethyl dicarbonate as a yeast inhibitor in wine. 598-55-0
Final Rule Indirect Food Additives: Adjuvants, Production Aids, and Sanitizers Amendment of food additive regulations to provide for the safe use of 3,5-di-tert-butyl-4-hydroxyhydrocinnamic acid triester with 1,3,5-tris(2-hydroxyethyl)-s-triazine-2,4,6-(1H,3H,5H)-trione as an antioxidant for polyester elastomers in contact with dry food and rubber articles intended for repeated use in contact with food.

January 19, 1994 -- 59 FR 2733
Because ethyl acrylate may be present in the additive, data from the NTP toxicology and carcinogenesis study on ethyl acrylate (TR-259) were used to estimate the upper-bound limit of lifetime human risk. 140-88-5

Occupational Safety and Health Administration (OSHA)

Notice Type Title Summary of Notice NTP Information Cited CASRN
Proposed Rule Respiratory Protection OSHA is proposing to modify its existing standards on respiratory protection so that employers will provide effective protection for employees who wear respirators. agents include saccharin and di-2-ethylhexyl phthalate (DEHP).

November 15, 1994 -- 59 FR 58884
One of the respiratory protection testing agents was di-2-ethylhexyl phthalate (DEHP). OSHA cites positive carcinogenic findings of DEHP in two rodent species by NTP as sufficient evidence to preclude its use in respirator quantitative fit testing. TR-217 117-81-7
Final Rule Hazard Communication Requirement of employers to establish hazard communication programs to transmit information on the hazards of chemicals to their employees by means of labels on containers, material safety data sheets, and training programs.

February 09, 1994 -- 59 FR 6126
Annual Report on Carcinogens published by the NTP is used by OSHA in identifying toxic substances to be regulated. N/A