[Federal Register Volume 62, Number 205 (Thursday, October 23, 1997)]
[Rules and Regulations]
[Pages 55160-55161]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-28016]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 520, 524, 556, and 558
Animal Drugs, Feeds, and Related Products; Famphur
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule.
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SUMMARY: The Food and Drug Administration (FDA) is amending the animal
drug regulations to specify the tolerance for residues of famphur in
cattle products. The residue tolerances were originally issued in FDA's
regulations under tolerances and exemptions from tolerances for
pesticide chemicals in or on raw agricultural commodities, and
subsequently moved to the Environmental Protection Agency's (EPA's)
regulations for residues of pesticides. Subsequent FDA new animal drug
approvals with the same tolerances, instead of stating the tolerances,
cross-referenced EPA's regulations. This action is being taken because
EPA has removed the tolerance from its regulations.
EFFECTIVE DATE: October 23, 1997.
FOR FURTHER INFORMATION CONTACT: Lonnie W. Luther, Center for
Veterinary Medicine (HFV-102), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855, 301-594-1623.
SUPPLEMENTARY INFORMATION: FDA has several approved new animal drug
applications (NADA's) providing for use of various famphur products.
Three NADA's sponsored by Mallinckrodt Veterinary, Inc., Mundelein, IL
60060, are:
NADA 34-266: Famix Famphur Type A article (for Type C cattle feed).
NADA 34-697: Warbex Famphur Cattle Pour-On/Bo-Anna Famphur Cattle
Insecticide.
NADA 139-858: Tramisol-X-Tra (Famphur/Levamisole) Cattle
Anthelmintic and Ectoparasite Paste.
One NADA sponsored by PM Resources, Inc., 13001 St. Charles Rock
Rd., Bridgeton, MO 63044, is:
NADA 43-215: Purina Grub-Kill (Famphur).
Tolerances for residues of famphur including its oxygen analog in
or on the raw agricultural commodities meat, fat, and meat byproducts
of cattle had been established under 21 CFR 120.233 (33 FR 2935,
February 14, 1968). Those provisions were subsequently transferred to
EPA and redesignated as 40 CFR 180.233 (36 FR 424, January 13, 1971,
interim rule; and 36 FR 22369 at 22564, November 25, 1971, final rule)
at 0.1 part per million. FDA, in its approvals of famphur as a new
animal drug, established the same tolerance for residues of the drug.
Instead of specifying the tolerance in the regulations reflecting the
new animal drug approvals, the regulations cross-referenced to 40 CFR
180.233. EPA has revoked the tolerance for residues of famphur in or on
certain raw agricultural commodities because the pesticide no longer
was covered by EPA's food use registrations (59 FR 17754, April 14,
1994, proposed rule; and 60 FR 49798, September 27, 1995, final rule).
Because EPA has removed 40 CFR 180.233, FDA is amending its regulations
in 21 CFR 556.273 to establish the tolerances for residues of famphur
including its oxygen analog.
In addition, the tolerance citations in 21 CFR 520.1242g(e),
524.900(e), and 558.254(c) are amended to replace the cross-reference
to 40 CFR 180.233 with a reference to the residue tolerance specified
in 21 CFR part 556.
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.
List of Subjects
21 CFR Part 520
Animal drugs.
21 CFR Part 524
Animal drugs.
21 CFR Part 556
Animal drugs, Food, Residues.
21 CFR Part 558
Animal drugs, Animal feeds.
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 parts 520,
524, 556, and 558 are amended as follows:
PART 520--ORAL DOSAGE FORM NEW ANIMAL DRUGS
1. The authority citation for 21 CFR part 520 continues to read as
follows:
Authority: 21 U.S.C. 360b.
Sec. 520.1242g [Amended]
2. Section 520.1242g Levamisole resinate and famphur paste is
amended in paragraph (e) by removing ``40 CFR 180.233 (under the
chemical name)'' and adding in its place ``Sec. 556.273 of this
chapter.''
PART 524--OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS
3. The authority citation for 21 CFR part 524 continues to read as
follows:
Authority: 21 U.S.C. 360b.
[[Page 55161]]
Sec. 524.900 [Amended]
4. Section 524.900 Famphur is amended in paragraph (e) by removing
``40 CFR 180.233 under the chemical name'' and adding in its place
``Sec. 556.273 of this chapter.''
PART 556--TOLERANCES FOR RESIDUES OF NEW ANIMAL DRUGS IN FOOD
5. The authority citation for 21 CFR part 556 continues to read as
follows:
Authority: 21 U.S.C. 342, 360b, 371.
6. Section 556.273 is added to subpart B to read as follows:
Sec. 556.273 Famphur.
Tolerances are established for residues of famphur including its
oxygen analog in or on meat, fat, or meat byproducts of cattle at 0.1
part per million.
PART 558--NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS
7. The authority citation for 21 CFR part 558 continues to read as
follows:
Authority: 21 U.S.C. 360b, 371.
Sec. 558.254 [Amended]
8. Section 558.254 Famphur is amended in paragraph (c) by removing
``40 CFR 180.233'' and adding in its place ``Sec. 556.273 of this
chapter.''
Dated: September 9, 1997.
Robert C. Livingston,
Director, Office of New Animal Drug Evaluation, Center for Veterinary
Medicine.
[FR Doc. 97-28016 Filed 10-22-97; 8:45 am]
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