Regulation Under Specific Acts of Congress; Amendments

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BILLING CODE 3510-25-M FEDERAL TRADE COMMISSION ;■ .

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- , 16 CFR Parts 300,301, and 303 Regulation Under Specific Acts of Congress; Amendments Correction In FR Doc. 80^-19763 appearing on page 44260 in the issue of Tuesday, July 1,1980, make the following corrections: (1) In the last line of the third column of page 44261, change “. . . paragraph (a) 1. .

to read . . paragraph (a) (2) In the middle column of page 44262, in the third line of paragraph (b) of § 300.28, “. . . would and in part of . . .” should have read “. » . wool and in part o f. . /*.

BILLING CODE 1505-01-M ENVIRONMENTAL PROTECTION AGENCY 21 CFR Part 193 (FRL 1549-8; FAP 8H5197/R591 Tolerances for Pesticides in Food Administered by the Environmental Protection Agency; Bendiocarb AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

s u m m a r y : This rule establishes/food additive regulation related to the experimental use of the insecticide bendiocarb (2,2-dimethyl-l,3benzodioxol-4-ol methyl carbamate) and its metabolites 2,2-dime thy 1-1,3benzodioxol-4-ol and N-hydroxymethyl bendiocarb in or on com. The regulation was requested by Fisons Corporation. This rule will permit the marketing of ’ com oil while further data is collected on the subject pesticide. EFFECTIVE DATE: July 25,1980. FOR FURTHER INFO RM ATION CONTACT*. Charles Mitchell, Product Manager (PM) 12, Registration Division (TS-767), Office of Pesticide Programs, Environmental Protection Agency, 401 M St., S.W., Washington, D.C. 20460 202/ 426-2635.

The data submitted in the petition and other relevant material have been evaluated. The toxicological data considered in support of the proposed tolerance included a 90-day rat feeding study with a no-observable-effect level (NOEL) of 10 parts per million (ppm) (ChE) and 250 ppm (systemic); a 90-day dog feeding study with a NOEL of 20 ppm (ChE); and acute delayed

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Federal Register / Vol. 45, No. 145 / Friday July 25, 1980 / Rules and Regulations 49543 neurotoxicity study which was negative at 60 milligrams (mg)/kilograms (kg) and a teratology study which was negative at up to 4 mg/kg (highest dose tested). A food additive regulation (21 CFR 193.152) has previously been established for bendiocarb in food-handling establishments. (A related document concerning the establishment of temporary tolerances of residues of the insecticide in or on the raw agricultural commodities: com grain, com fodder, com forage, milk, fat, meat, and meat byproducts (except kidney) of cattle, goats, hogs, horses, poultry, and sheep; kidney of cattle, goats, hogs, horses, poultry, and sheep; and eggs appears elsewhere in today’s Federal Register). Two-year mouse and dog feeding studies and a 2-year rat feeding/ reproduction study are currently underway and 1-year interim reports have been submitted and reviewed by the Agency. In a letter of March 31,1980, the petitioner agreed to voluntarily discontinue the use of the proposed tolerance if the results of die 2-year mouse and dog feeding study and the 2year rat feeding/reproduction study are found to exceed the risk criteria for unreasonable adverse effects. The metabolism of bendiocarb is adequately understood and an adequate analytical method (GLC system equipped with electron capture detector) is available for enforcement purposes. No actions are currendy pending against continued registration of bendiocarb nor are there any other relevant consideration^ involved in establishing the proposed tolerance. The pesticide is considered useful for the purpose for which a tolerance is sought. Therefore the regulation establishing a tolerance limitation of 0.1 parts per million (ppm) in com oil by amending 21 CFR 193.152 is being promulgated as proposed. Accordingly, a food additive regulation is established as set forth below. Any person adversely affected by this regulation may, within 30 days after publication in the Federal Register, file written objections with the Hearing Clerk, EPA, Rm. M-3708 (A-100), 401M Street, SW, Washington, DC 20460. Such objections should be submitted in quintuplicate and specify the provisions of the regulation deemed to be objectionable and the grounds for the objections. If a hearing is requested, the objections must state the issues for the hearing. A hearing will be granted if the objections are supported by grounds legally sufficient to justify the relief sought.

Effective July 25,1980, 21 CFR 193.152 is amended as set forth below. (Sec. 409(c)(1) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 348 (c)(1)]) Dated: July 10,1980.

Edwin L Johnson, Deputy Assistant Administrator o f Pesticide Programs.

Part 193, Subpart A, is amended by adding paragraph (c) to § 193.152 to read as follows:

§ 193.152 2,2-dimethyl-1,3-benzodioxol-4ol methyl carbamate.

* * * * * (c) A tolerance of 0.1 parts per million (ppm) is established for residues of the insecticide bendiocarb (2,2-dimethyl-l,3benzodioxol-4-ol methyl carbamate) and its metabolites 2,2-dimethyl-l,3benzidioxol-4-ol and N-hydroxymethyl bendiocarb in com oil intended for food use resulting from application <jf the insecticide to the raw agricultural commodity growing com. Such residues may be present therein only as a result of the application of the insecticide to growing com under an experimental use ^ permit which expires August 2,1980. [FR Doc. BO-22566 Filed 7-24-80; 8:45 am]