2011-23867. Tolerances for Residues of New Animal Drugs in Food; Progesterone

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Final rule; technical amendment.

SUMMARY:

The Food and Drug Administration (FDA) is amending the animal drug regulations to update the allowable incremental increase for residues of progesterone in edible tissues of cattle and sheep based on the 1994 revised daily consumption values. This action is being taken to improve the accuracy of the regulations.

DATES:

This rule is effective September 19, 2011.

FOR FURTHER INFORMATION CONTACT:

Kevin Gaido, Center for Veterinary Medicine (HFV-153), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 240-276-8212, e-mail: [e-mail].

SUPPLEMENTARY INFORMATION:

Section 512(i) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360b(i)) (21 CFR 514.105(a)) directs FDA to establish tolerances by regulation, as necessary, when a new animal drug is approved for use in food-producing animals. Progesterone is approved for use in subcutaneous implants used for increased rate of weight gain in suckling beef calves and steers (21 CFR 522.1940) and in vaginal inserts used for management of the estrous cycle in female cattle and ewes (21 CFR 529.1940).

FDA has noticed the animal drug tolerance regulations do not reflect levels for progesterone using the daily consumption values in the current guidance document, “Guideline for Establishing a Safe Concentration” (59 FR 37499, July 22, 1994). At this time, FDA is amending 21 CFR 556.540 to reflect the revised daily consumption values as applied to edible tissues of cattle. Sheep are considered a minor species for human food safety assessment, and the updated allowable incremental increase limits for cattle tissues based on the revised daily consumption values are applicable to sheep. This action is being taken to improve the accuracy of the regulations.

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. Revise § 556.540 to read as follows:

§ 556.540

Progesterone.

(a) [Reserved]

(b) Tolerances. Residues of progesterone are not permitted in excess of the following increments above the concentrations of progesterone naturally present in untreated animals:

(1) Cattle and sheep—(i) Muscle: 5 parts per billion (ppb).

(ii) Liver: 15 ppb.

(iii) Kidney: 30 ppb.

(iv) Fat: 30 ppb.

(2) [Reserved]

(c) Related conditions of use. See §§ 522.1940 and 529.1940 of this chapter.

Dated: September 13, 2011.

Bernadette Dunham,

Director, Center for Veterinary Medicine.