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Regulatory Actions for Year 1993

Year Agency Title CASRN
1993 EPA
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.

NTP Information Cited
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.

  • Type: Notice
  • December 29, 1993
  • 58 FR 68826
7681-49-4
1993 EPA
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).

NTP Information Cited
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).

  • Type: Final Rule
  • December 01, 1993
  • 58 FR 63500
64-18-6
1993 EPA
Pesticide Tolerances for Dicamba

Establishment of a tolerance for the combined residues of the herbicide dicamba and its 5-hydroxy metabolite.

NTP Information Cited
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.

  • Type: Final Rule
  • November 24, 1993
  • 58 FR 62039
33857-26-0
1993 EPA
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.

NTP Information Cited
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.

  • Type: Final Rule
  • November 22, 1993
  • 58 FR 61654
121-69-7
1993 EPA
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).

NTP Information Cited
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.

  • Type: Proposed Rule
  • November 22, 1993
  • 58 FR 61649
140-88-5
1993 EPA
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.

NTP Information Cited
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.

  • Type: Final Rule
  • November 10, 1993
  • 58 FR 59663
62-73-7
1993 EPA
Pesticide Tolerance for Dimethoate

Establishment of a tolerance for residues of the insecticide dimethoate in or on raw Brussels sprouts.

NTP Information Cited
NTP concluded that dimethoate is a mutagenic compound based on its testing for gene mutation and chromosomal aberrations.

  • Type: Proposed Rule
  • September 01, 1993
  • 58 FR 46147
60-51-5
1993 EPA
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.

NTP Information Cited
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.

  • Type: Final Rule
  • July 14, 1993
  • 58 FR 37862
96-45-7
1993 EPA
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.

NTP Information Cited
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.

  • Type: Proposed Rule
  • June 30, 1993
  • 58 FR 34973
147-14-8
1328-53-6
1993 FDA
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.

NTP Information Cited
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.

  • Type: Tentative Final Rule
  • May 12, 1993
  • 58 FR 27959
87-86-5
1993 EPA
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.

NTP Information Cited
Data from the NTP toxicology and carcinogenesis study of sodium fluoride (TR-393) was considered in support of the tolerances.

  • Type: Final Rule
  • May 05, 1993
  • 58 FR 26687
7681-49-4
1993 EPA
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.

NTP Information Cited
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.

  • Type: Final Decision
  • March 09, 1993
  • 58 FR 13008
10028-15-6