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Regulatory Actions for Year 1993


Environmental Protection Agency (EPA)

Notice Type Title Summary of Notice NTP Information Cited CASRN
Notice Drinking Water Maximum Contaminant Level Goal; Fluoride Announcement of decision not to revise the maximum contaminant level goal (MCLG) for fluoride after consideration of recent reports concerning the health effects of fluoride.

December 29, 1993 -- 58 FR 68826
NTP toxicology and carcinogenesis study of fluoride (TR-393) cited. Study concluded that there was equivocal evidence in male F344/N rats, and no evidence in female F344/N rats or male or female mice. 7681-49-4
Final Rule Chemicals; Toxic Chemical Release Reporting; Community Right-to-Know; Significant New Use Rule Final Rule: Addition of 21 chemicals and 2 chemical categories to the list of toxic chemicals under section 313 of the Emergency Planning and Community Right-to-Know Act of 1986 (EPCRA).

December 01, 1993 -- 58 FR 63500
NTP toxicity study of formic acid (TOX-19) demonstrated sufficient evidence to establish that formic acid can reasonably be anticipated to cause in humans chronic health effects as described in EPCRA section 313(d)(2)(B). 64-18-6
Final Rule Pesticide Tolerances for Dicamba Establishment of a tolerance for the combined residues of the herbicide dicamba and its 5-hydroxy metabolite.

November 24, 1993 -- 58 FR 62039
Negative results of NTP toxicology and carcinogenesis study of dichlorodibenzo-p-dioxin (TR-123) cited. The Agency has concluded that there is no potential carcinogenic risk to humans from a DCDD impurity in the dicamba to be used on cotton. 33857-26-0
Final Rule Acetophenone, Phenol, N,N-Dimethylaniline, Ethyl Acetate, and 2,6-Dimethylphenol; Proposed Test Rule, Notice of Opportunity to Initiate Negotiations for TSCA Section 4 Testing Consent Agreements Proposed Rule: Proposed test rule under section 4(a) of the Toxic Substances Control Act (TSCA) that would require manufacturers and processors of five chemicals, acetophenone, phenol, n, n-dimethylaniline, ethyl acetate, and 2,6-dimethylphenol, to conduct testing for certain chemical fate, health and environmental effects.

November 22, 1993 -- 58 FR 61654
The proposed rule reflects EPA's current thinking in the area of mutagenicity testing, both as an endpoint and as it leads to oncogenicity testing. This new information is partially based on data from the NTP's study of the ability of short-term tests to predict carcinogenic potential. For phenol, no additional testing for developmental effects is being proposed because NTP studies are adequate for this endpoint. For N,N-dimethylaniline, the NTP toxicology and carcinogenesis study (TR-360) identified the rat as more sensitive than the mouse to the noncarcinogenic effects on erythrocytes and spleen. 121-69-7
Proposed Rule Significant New Uses of Certain Acrylate Esters Proposed a significant new use rule (SNUR) under section 5(a)(2) of the Toxic Substances Control Act for all acrylate esters falling within the definition proposed in this rule (acrylate substances).

November 22, 1993 -- 58 FR 61649
The EPA has concluded certain acrylates may present a risk of cancer. This conclusion is based primarily upon data available for a subset of acrylates which have demonstrated positive results. The NTP toxicology and carcinogenesis study of ethyl acrylate (TR-259) used to support conclusion. 140-88-5
Final Rule Dichlorvos: Revocation of Food Additive Tolerance Revocation of the food additive regulation for residues of the pesticide dichlorvos in or on packaged or bagged non perishable processed food.

November 10, 1993 -- 58 FR 59663
Data from the NTP toxicology and carcinogenesis study of dichlorvos (TR-342) in F344 rats showing statistically significant increases in leukemia in males at 2 dose levels was used. 62-73-7
Proposed Rule Pesticide Tolerance for Dimethoate Establishment of a tolerance for residues of the insecticide dimethoate in or on raw Brussels sprouts.

September 01, 1993 -- 58 FR 46147
NTP concluded that dimethoate is a mutagenic compound based on its testing for gene mutation and chromosomal aberrations. 60-51-5
Final Rule Revocation of Food Additive Regulations for Benomyl, Mancozeb, Phosmet, and Trifluralin Revocation of certain food additive regulations for four pesticides, benomyl, mancozeb, phosmet, and trifluralin, which were included in a 1989 petition.

July 14, 1993 -- 58 FR 37862
Ethylene thiourea (ETU), a major contaminant, metabolite and breakdown product of mancozeb has been shown in the NTP toxicology and carcinogenesis study (TR-388) to induce cancer in animals. 96-45-7
Proposed Rule C.I. Pigment Violet #23 (Carbazole Violet), C.I. Pigment Blue #15, C.I. Pigment Green #7, and FD & C Red No. 40; Tolerance Exemptions Exemption from the requirement of a tolerance be established for residues of C.I. Pigment Violet #23, C.I. Pigment Blue #15, C.I. Pigment Green #7 and FD Red No. 40 when used as inert ingredients in pesticide formulations applied to growing crops only.

June 30, 1993 -- 58 FR 34973
NTP data used to support the proposed tolerance exemptions for C.I. Pigment Blue #15 and C.I. Pigment Green #7. The NTP decided not to perform toxicology and carcinogenesis studies of C.I. Pigment Green #7 and C.I. Pigment Blue #15 based on the lack of absorption or adverse effects in a 90-day feed study in rats and mice. 147-14-8
1328-53-6
Final Rule Pesticide Tolerance and Animal Feed Additive Regulation for Fluoride Compounds Establishment of a 3-year time-limited tolerance for residues of cryolite and/or synthetic cryolite.

May 05, 1993 -- 58 FR 26687
Data from the NTP toxicology and carcinogenesis study of sodium fluoride (TR-393) was considered in support of the tolerances. 7681-49-4
Final Decision National Ambient Air Quality Standards For Ozone. Announcement that revisions of the national ambient air quality standards for ozone are not appropriate at this time.

March 09, 1993 -- 58 FR 13008
Substantial new information has been published since the last criteria document. The NTP toxicology and carcinogenesis study on ozone (TR-440) to be peer-reviewed 11/93 was cited as an example of a study which may yield significant new information. 10028-15-6

Food and Drug Administration (FDA)

Notice Type Title Summary of Notice NTP Information Cited CASRN
Tentative Final Rule Pesticide Tolerance and Animal Feed Additive Regulation for Fluoride Compounds Tentative Final Rule: Tentative affirmation that gelatin is generally recognized as safe (GRAS) for use as a direct human food ingredient.

May 12, 1993 -- 58 FR 27959
Data from the NTP toxicology and carcinogenesis study on penta­chloro­phenol (TR-349) showing PCP induces carcinogenic neoplasms in mice was used in modifying the regulation to state that there shall be no detectable levels of PCP in gelatin when tested by the method referenced in this regulation. 87-86-5