
[Federal Register Volume 76, Number 181 (Monday, September 19, 2011)]
[Rules and Regulations]
[Page 57907]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-23867]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 556

[Docket No. FDA-2011-N-0003]


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: kevin.gaido@fda.hhs.gov.

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

0
1. The authority citation for 21 CFR part 556 continues to read as 
follows:

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


0
2. Revise Sec.  556.540 to read as follows:


Sec.  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 Sec. Sec.  522.1940 and 529.1940 
of this chapter.

    Dated: September 13, 2011.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. 2011-23867 Filed 9-16-11; 8:45 am]
BILLING CODE 4160-01-P


