00-9578. Tolerances for Residues of New Animal Drugs in Food; Fenbendazole

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Final rule.

SUMMARY:

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a supplemental new animal drug application (NADA) filed by Hoechst Roussel Vet. The supplemental NADA provides for establishing tolerances for residues of fenbendazole in edible tissues of swine. Technical corrections are also made.

DATES:

This rule is effective April 18, 2000.

FOR FURTHER INFORMATION CONTACT:

Janis R. Messenheimer, Center for Veterinary Medicine (HFV-130), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 301-827-7578.

SUPPLEMENTARY INFORMATION:

Hoechst Roussel Vet, Perryville Corporate Park III, P.O. Box 4010, Clinton, NJ 08809-4010, filed a supplement to NADA 131-675 that provides for use of Safe-Guard® (20 percent fenbendazole) Type A medicated articles to make Type B and C medicated swine feeds. The supplement provides for establishing tolerances for parent fenbendazole in swine liver and muscle. The supplement is approved as of February 10, 2000, and § 556.275 (21 CFR 556.275) is amended to reflect the approval. The basis of approval is discussed in the freedom of information summary.

Section 556.275 is further amended by deleting references to safe concentrations and by adding the previously established acceptable daily intake (ADI) of total residues of fenbendazole. The footnote for “tolerance” in that section is also removed.

In accordance with the freedom of information provisions of 21 CFR part 20 and 514.11(e)(2)(ii), a summary of safety and effectiveness data and information submitted to support approval of this application may be seen in the Dockets Management Branch (HFA-305), Food and Drug Administration, rm. 1061, 5630 Fishers Lane, Rockville, MD 20852, from 9 a.m. to 4 p.m., Monday through Friday.

The agency has determined under 21 CFR 25.33(a)(1) that this action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required.

This rule does not meet the definition of “rule” in 5 U.S.C. 804(3)(A) because it is a rule of “particular applicability.” Therefore, it is not subject to the congressional review requirements in 5 U.S.C. 801-808.

List of Subjects in 21 CFR Part 556

• Animal drugs
• Foods

Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs and redelegated to the Center for Veterinary Medicine, 21 CFR part 556 is amended as follows:

PART 556—TOLERANCES FOR RESIDUES OF NEW ANIMAL DRUGS IN FOOD

1. The authority citation for 21 CFR part 556 continues to read as follows:

Authority: 21 U.S.C. 342, 360b, 371.

2. Section 556.275 is revised to read as follows:

§ 556.275

Fenbendazole.

(a) Acceptable daily intake (ADI). The ADI for total residues of fenbendazole is 40 micrograms per kilogram of body weight per day.

(b) Tolerances—(1) Cattle—(i) Liver (the target tissue). The tolerance for parent fenbendazole (the marker residue) is 0.8 part per million (ppm).

(ii) [Reserved]

(iii) Milk. The tolerance for fenbendazole sulfoxide metabolite (the marker residue in cattle milk) is 0.6 ppm.

(2) Swine—(i) Liver (the target tissue). The tolerance for parent fenbendazole (the marker residue) is 6 ppm.

(ii) Muscle. The tolerance for parent fenbendazole (the marker residue) is 2 ppm.

(3) Goats—(i) Liver (the target tissue). The tolerance for parent fenbendazole (the marker residue) is 0.8 ppm.

(ii) [Reserved]

Dated: March 17, 2000.

Claire M. Lathers,

Director, Office of New Animal Drug Evaluation, Center for Veterinary Medicine.