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