Tolerances for Residues of New Animal Drugs in Food; 2-Acetylamino-5-Nitrothiazole; Buquinolate; Chlorobutanol; Estradiol and Related Esters; Ethylenediamine; Florfenicol; Flunixin; Furazolidone; Hydrocortisone; Methylparaben; Methylprednisolone; Prednisolone; Prednisone; Progesterone; Propylparaben; and Salicylic Acid, 16290-16291 [2011-6796]
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16290
Federal Register / Vol. 76, No. 56 / Wednesday, March 23, 2011 / Rules and Regulations
to the objections and is denying the
requests for a hearing. In addition,
FWW’s request for a stay of the
effectiveness of the August 18, 2006,
regulation until a hearing is held is
moot because FDA is denying the
hearing request. FDA is confirming
August 18, 2006, as the effective date of
the regulation.
VI. References
The following references have been
placed on display in the Division of
Dockets Management (see ADDRESSES)
and may be seen by interested persons
between 9 a.m. and 4 p.m. Monday
through Friday.
1. ‘‘Evaluating the Safety of Food
Chemicals,’’ National Research Council,
National Academy of Sciences,
Washington DC, p. 55.
2. Jacobs, T., A. Darji, N. Frahm, et al.,
‘‘Listeriolysin O: Cholesterol Inhibits
Cytolysis But Not Binding to Cellular
Membranes,’’ Molecular Microbiology,
28:1081–1089, 1998.
3. U.S. Department of Agriculture
Nutritive Value of Foods, Home and
Garden Bulletin Number 72, USDA,
Agricultural Research Service.
4. Guyton, A.C., J.E. Hall, Textbook of
Medical Physiology (9th ed.)
Philadelphia: W.B. Saunders Co., p. 817,
1996.
Dated: March 17, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011–6792 Filed 3–22–11; 8:45 am]
BILLING CODE 4160–01–P
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; 2-Acetylamino5-Nitrothiazole; Buquinolate;
Chlorobutanol; Estradiol and Related
Esters; Ethylenediamine; Florfenicol;
Flunixin; Furazolidone;
Hydrocortisone; Methylparaben;
Methylprednisolone; Prednisolone;
Prednisone; Progesterone;
Propylparaben; and Salicylic Acid
AGENCY:
Food and Drug Administration,
erowe on DSK5CLS3C1PROD with RULES
HHS.
Final rule; correcting
amendments.
ACTION:
The Food and Drug
Administration (FDA) is amending the
animal drug regulations to reflect the
revocation of tolerances for residues of
SUMMARY:
VerDate Mar<15>2010
15:27 Mar 22, 2011
Jkt 223001
various substances in food because
approval has been withdrawn for the
underlying food additive petitions
(FAPs) or new animal drug applications
(NADAs). This action is being taken to
improve the accuracy of the regulations.
DATES: This rule is effective March 23,
2011.
FOR FURTHER INFORMATION CONTACT:
George K. Haibel, Center for Veterinary
Medicine (HFV–6), Food and Drug
Administration, 7519 Standish Pl.,
Rockville, MD 20855, 240–276–9019,
e-mail: george.haibel@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Section
512(i) of the Federal Food, Drug, and
Cosmetic Act (the FD&C 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. However, section 512(i) of the
FD&C Act (21 CFR 514.115(e)) also
obligates FDA to revoke such tolerance
regulations upon the withdrawal of
approval of the related NADA.
FDA has noticed that the animal drug
regulations contain tolerances for
residues of substances in food that were
established by approval of FAPs for
animal drug products prior to the
Animal Drug Amendments of 1968 or by
NADA for which an underlying
application for use in a food-producing
species is not currently approved.
Following codification of the tolerance,
the underlying FAP may have been
withdrawn, or an NADA for the same
drug product was not filed or was
withdrawn, either voluntarily or for
cause. When regulations for these
products were removed or omitted from
various redesignation rules, the
appropriate conforming amendments to
remove the revoked tolerances from part
556 (21 CFR part 556) were not made.
The following chemical substances and
new animal drugs have codified
tolerances for which FDA finds no
applications with corresponding
approved conditions of use in foodproducing animals:
1. 2-Acetylamino-5-nitrothiazole
(§ 556.20). In 1979, FDA acknowledged
the voluntary withdrawal of approval of
NADA 9–424 for use of 2-acetylamino5-nitrothiazole for use in turkey feed
and revoked 21 CFR 558.25 (44 FR
40888, July 13, 1979), but did not
amend part 556 to remove the
associated tolerances.
2. Chlorobutanol (§ 556.140). In 1963,
FDA established a tolerance for
chlorobutanol in milk of dairy animals
at § 121.1131 (21 CFR 121.1131)
incidental to the approval of an FAP for
a combination drug, antibiotic/steroid
intramammary infusion (28 FR 4948,
PO 00000
Frm 00060
Fmt 4700
Sfmt 4700
May 17, 1963). Section 121.1131 was
redesignated as 21 CFR 135g.31 (35 FR
15372 at 15376, October 2, 1970) and as
§ 556.140 (40 FR 13802 at 13947, March
27, 1975).
3. Estradiol and progesterone in
edible tissues of lambs (§§ 556.240 and
556.540). In 1973, FDA acknowledged
the voluntary withdrawal of approval of
a subcutaneous implant for use in lambs
containing estradiol benzoate and
progesterone under NADA 9–442 (38 FR
7481, March 22, 1973). Subsequently,
FDA removed the approved conditions
of use in 21 CFR 522.1940 (44 FR 6707
at 6708, February 2, 1979), but did not
amend part 556 to remove the
associated tolerances in uncooked
edible tissues of lambs.
4. Ethylenediamine (§ 556.270). In
1965, FDA established a tolerance for
ethylenediamine in milk of dairy
animals at § 121.1184 (21 CFR 121.1184)
incidental to the approval of an FAP for
a combination drug, antibiotic
intramammary infusion (30 FR 11952 at
11954, September 18, 1965). Section
121.1184 was redesignated as 21 CFR
135g.48 (35 FR 15372 at 15378) and as
§ 556.270 (40 FR 13802 at 13950).
5. Furazolidone (§ 556.290). In 1963,
FDA established a tolerance for
furazolidone in uncooked edible tissues
of swine at § 121.2582 (21 CFR
121.2582) incidental to the approval of
an FAP for use in medicated swine feed
(28 FR 12664 at 12665, November 28,
1963). Section 121.2582 was
redesignated as 21 CFR 121.1145 (30 FR
15845 at 15917, December 23, 1965), as
21 CFR 135g.36 (35 FR 15372 at 15376),
and as § 556.290 (40 FR 13802 at 13950).
In 1971, FDA proposed to withdraw
approval of NADAs for use of
furazolidone in food-producing animals
on grounds that the drug, when
administered to laboratory animals, was
shown to produce tumors (36 FR 5927,
March 31, 1971) and in 1991 withdrew
approval after a full evidentiary hearing
(56 FR 41902, August 23, 1991).
Currently, there is no approved
application for use of furazolidone in a
food-producing species. A 1996 order
codified a prohibition of extralabel use
of furazolidone in food-producing
animals (61 FR 57732 at 57743,
November 7, 1996 as amended 67 FR
5470 at 5471, February 6, 2002). See 21
CFR 530.41(a)(7).
6. Hydrocortisone (§ 556.320). In
1970, FDA established a tolerance for
hydrocortisone in milk of dairy animals
at § 135g.3 (21 CFR 135g.3) incidental to
the approval of an FAP for a
combination drug, antibiotic/steroid
intramammary infusion (35 FR 12332 at
12333, August 1, 1970). Section 135g.3
E:\FR\FM\23MRR1.SGM
23MRR1
erowe on DSK5CLS3C1PROD with RULES
Federal Register / Vol. 76, No. 56 / Wednesday, March 23, 2011 / Rules and Regulations
was redesignated as § 556.320 (40 FR
13802 at 13950).
7. Methylparaben (§ 556.390). In 1964,
FDA established a tolerance for
methylparaben in milk of dairy animals
at § 121.1158 (21 CFR 121.1158)
incidental to the approval of an FAP for
a combination drug, antibiotic
intramammary infusion (29 FR 14624,
October 27, 1964). Section 121.1158 was
redesignated as 21 CFR 135g.41 (35 FR
15372 at 15376) and as § 556.390 (40 FR
13802 at 13956).
8. Methylprednisolone (§ 556.400). In
1970, FDA established a tolerance for
methylprednisolone in milk of dairy
animals at § 135g.67 (21 CFR 135g.67)
incidental to the approval of an FAP for
a combination drug, antibiotic/steroid
intramammary infusion (35 FR 12332 at
12333). Section 135g.67 was
redesignated as § 556.400 (40 FR 13802
at 13956).
9. Prednisolone (§ 556.520). In 1964,
FDA established a tolerance for
prednisolone in milk of dairy animals at
§ 121.1147 (21 CFR 121.1147) incidental
to the approval of an FAP for a
combination drug, antibiotic
intramammary infusion (29 FR 3393,
March 14, 1964). Section 121.1147 was
redesignated as 21 CFR 135g.37 (35 FR
15372 at 15376) and as § 556.520 (40 FR
13802 at 13956).
10. Prednisone (§ 556.530). In 1964,
FDA established a tolerance for
prednisone in milk of dairy animals at
§ 121.1157 (21 CFR 121.1157) incidental
to the approval of an FAP for a
combination drug, antibiotic
intramammary infusion (29 FR 14624).
Section 121.1157 was redesignated as 21
CFR 135g.40 (35 FR 15372 at 15376) and
as § 556.530 (40 FR 13802 at 13956).
11. Propylparaben (§ 556.550). In
1964, FDA established a tolerance for
propylparaben in milk of dairy animals
at § 121.1159 incidental to the approval
of an FAP for a combination drug,
antibiotic intramammary infusion (29
FR 14624). Section 121.1159 was
redesignated as 21 CFR 135g.42 (35 FR
15372 at 15376) and as § 556.550 (40 FR
13802 at 13956).
12. Salicylic acid (§ 556.590). In 2005,
FDA acknowledged the voluntary
withdrawal of approval of salicylic acid
for use in cattle under NADA 010–481
and revoked 21 CFR 529.2090 (70 FR
50181, August 26, 2005), but did not
remove the associated tolerance.
At this time, FDA is revoking the
tolerances for 2-acetylamino-5nitrothiazole, buquinolate,
chlorobutanol, estradiol in lamb,
ethylenediamine, furazolidone,
hydrocortisone, methylparaben,
methylprednisolone, prednisolone,
prednisone, progesterone in lamb,
VerDate Mar<15>2010
15:27 Mar 22, 2011
Jkt 223001
propylparaben, and salicylic acid.
Accordingly, §§ 556.20, 556.140,
556.270, 556.290, 556.320, 556.390,
556.400, 556.520, 556.530, 556.550, and
556.590 are being removed, and
§§ 556.240 and 556.540 are being
amended to reflect the revoked
tolerances.
Also, FDA is amending the animal
drug regulations in §§ 556.283 and
556.286 to cross reference an approved
combination drug injectable solution
containing florfenicol and flunixin (75
FR 1274, January 11, 2010). FDA is
further amending § 556.286 to reflect the
marker residue in milk for residues of
flunixin meglumine. This action is
being taken to comply with section.
512(i) of the FD&C Act and 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.
§ 556.20
■
7. In § 556.286, revise paragraphs
(b)(1)(iii) and (c) to read as follows:
■
§ 556.286
*
*
*
*
(b) * * *
(1) * * *
(iii) Milk: 2 ppb 5-hydroxy flunixin.
*
*
*
*
*
(c) Related conditions of use. See
§§ 522.956 and 522.970 of this chapter.
§ 556.290
■
■
[Removed]
10. Remove § 556.390.
§ 556.400
[Removed]
11. Remove § 556.400.
[Removed]
12. Remove § 556.520.
§ 556.530
■
[Removed]
9. Remove § 556.320.
§ 556.390
■
[Removed]
8. Remove § 556.290.
§ 556.320
■
[Amended]
Flunixin.
*
§ 556.520
[Removed]
3. Remove § 556.140.
§ 556.240
(ii) Muscle. The tolerance for
florfenicol amine (the marker residue) is
0.3 ppm.
(2) Swine—(i) Liver (the target tissue).
The tolerance for parent florfenicol (the
marker residue) is 2.5 ppm.
(ii) Muscle. The tolerance for parent
florfenicol (the marker residue) is 0.2
ppm.
(3) Catfish. The tolerance for
florfenicol amine (the marker residue) in
muscle (the target tissue) is 1 ppm.
(4) Salmonids. The tolerance for
florfenicol amine (the marker residue) in
muscle/skin (the target tissues) is 1
ppm.
(c) Related conditions of use. See
§§ 520.955, 522.955, 522.956, and
558.261 of this chapter.
■
2. Remove § 556.20.
§ 556.140
■
[Removed]
16291
[Removed]
13. Remove § 556.530.
4. In § 556.240, remove and reserve
paragraph (b).
§ 556.540
§ 556.270
■
■
■
■
[Removed]
5. Remove § 556.270.
6. Revise § 556.283 to read as follows:
§ 556.283
(a) Acceptable daily intake (ADI). The
ADI for total residues of florfenicol is 10
micrograms per kilogram of body weight
per day.
(b) Tolerances—(1) Cattle—(i) Liver
(the target tissue). The tolerance for
florfenicol amine (the marker residue) is
3.7 parts per million (ppm).
PO 00000
Frm 00061
Fmt 4700
14. In § 556.540, remove and reserve
paragraph (b).
§ 556.550
■
Florfenicol.
Sfmt 9990
[Amended]
15. Remove § 556.550.
§ 556.590
■
[Removed]
[Removed]
16. Remove § 556.590.
Dated: March 17, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011–6796 Filed 3–22–11; 8:45 am]
BILLING CODE 4160–01–P
E:\FR\FM\23MRR1.SGM
23MRR1
]]>Agencies
[Federal Register Volume 76, Number 56 (Wednesday, March 23, 2011)]
[Rules and Regulations]
[Pages 16290-16291]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-6796]
-----------------------------------------------------------------------
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; 2-
Acetylamino-5-Nitrothiazole; Buquinolate; Chlorobutanol; Estradiol and
Related Esters; Ethylenediamine; Florfenicol; Flunixin; Furazolidone;
Hydrocortisone; Methylparaben; Methylprednisolone; Prednisolone;
Prednisone; Progesterone; Propylparaben; and Salicylic Acid
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule; correcting amendments.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is amending the animal
drug regulations to reflect the revocation of tolerances for residues
of various substances in food because approval has been withdrawn for
the underlying food additive petitions (FAPs) or new animal drug
applications (NADAs). This action is being taken to improve the
accuracy of the regulations.
DATES: This rule is effective March 23, 2011.
FOR FURTHER INFORMATION CONTACT: George K. Haibel, Center for
Veterinary Medicine (HFV-6), Food and Drug Administration, 7519
Standish Pl., Rockville, MD 20855, 240-276-9019, e[dash]mail:
george.haibel@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Section 512(i) of the Federal Food, Drug,
and Cosmetic Act (the FD&C 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. However,
section 512(i) of the FD&C Act (21 CFR 514.115(e)) also obligates FDA
to revoke such tolerance regulations upon the withdrawal of approval of
the related NADA.
FDA has noticed that the animal drug regulations contain tolerances
for residues of substances in food that were established by approval of
FAPs for animal drug products prior to the Animal Drug Amendments of
1968 or by NADA for which an underlying application for use in a food-
producing species is not currently approved. Following codification of
the tolerance, the underlying FAP may have been withdrawn, or an NADA
for the same drug product was not filed or was withdrawn, either
voluntarily or for cause. When regulations for these products were
removed or omitted from various redesignation rules, the appropriate
conforming amendments to remove the revoked tolerances from part 556
(21 CFR part 556) were not made. The following chemical substances and
new animal drugs have codified tolerances for which FDA finds no
applications with corresponding approved conditions of use in food-
producing animals:
1. 2-Acetylamino-5-nitrothiazole (Sec. 556.20). In 1979, FDA
acknowledged the voluntary withdrawal of approval of NADA 9-424 for use
of 2-acetylamino-5-nitrothiazole for use in turkey feed and revoked 21
CFR 558.25 (44 FR 40888, July 13, 1979), but did not amend part 556 to
remove the associated tolerances.
2. Chlorobutanol (Sec. 556.140). In 1963, FDA established a
tolerance for chlorobutanol in milk of dairy animals at Sec. 121.1131
(21 CFR 121.1131) incidental to the approval of an FAP for a
combination drug, antibiotic/steroid intramammary infusion (28 FR 4948,
May 17, 1963). Section 121.1131 was redesignated as 21 CFR 135g.31 (35
FR 15372 at 15376, October 2, 1970) and as Sec. 556.140 (40 FR 13802
at 13947, March 27, 1975).
3. Estradiol and progesterone in edible tissues of lambs
(Sec. Sec. 556.240 and 556.540). In 1973, FDA acknowledged the
voluntary withdrawal of approval of a subcutaneous implant for use in
lambs containing estradiol benzoate and progesterone under NADA 9-442
(38 FR 7481, March 22, 1973). Subsequently, FDA removed the approved
conditions of use in 21 CFR 522.1940 (44 FR 6707 at 6708, February 2,
1979), but did not amend part 556 to remove the associated tolerances
in uncooked edible tissues of lambs.
4. Ethylenediamine (Sec. 556.270). In 1965, FDA established a
tolerance for ethylenediamine in milk of dairy animals at Sec.
121.1184 (21 CFR 121.1184) incidental to the approval of an FAP for a
combination drug, antibiotic intramammary infusion (30 FR 11952 at
11954, September 18, 1965). Section 121.1184 was redesignated as 21 CFR
135g.48 (35 FR 15372 at 15378) and as Sec. 556.270 (40 FR 13802 at
13950).
5. Furazolidone (Sec. 556.290). In 1963, FDA established a
tolerance for furazolidone in uncooked edible tissues of swine at Sec.
121.2582 (21 CFR 121.2582) incidental to the approval of an FAP for use
in medicated swine feed (28 FR 12664 at 12665, November 28, 1963).
Section 121.2582 was redesignated as 21 CFR 121.1145 (30 FR 15845 at
15917, December 23, 1965), as 21 CFR 135g.36 (35 FR 15372 at 15376),
and as Sec. 556.290 (40 FR 13802 at 13950). In 1971, FDA proposed to
withdraw approval of NADAs for use of furazolidone in food-producing
animals on grounds that the drug, when administered to laboratory
animals, was shown to produce tumors (36 FR 5927, March 31, 1971) and
in 1991 withdrew approval after a full evidentiary hearing (56 FR
41902, August 23, 1991). Currently, there is no approved application
for use of furazolidone in a food-producing species. A 1996 order
codified a prohibition of extralabel use of furazolidone in food-
producing animals (61 FR 57732 at 57743, November 7, 1996 as amended 67
FR 5470 at 5471, February 6, 2002). See 21 CFR 530.41(a)(7).
6. Hydrocortisone (Sec. 556.320). In 1970, FDA established a
tolerance for hydrocortisone in milk of dairy animals at Sec. 135g.3
(21 CFR 135g.3) incidental to the approval of an FAP for a combination
drug, antibiotic/steroid intramammary infusion (35 FR 12332 at 12333,
August 1, 1970). Section 135g.3
[[Page 16291]]
was redesignated as Sec. 556.320 (40 FR 13802 at 13950).
7. Methylparaben (Sec. 556.390). In 1964, FDA established a
tolerance for methylparaben in milk of dairy animals at Sec. 121.1158
(21 CFR 121.1158) incidental to the approval of an FAP for a
combination drug, antibiotic intramammary infusion (29 FR 14624,
October 27, 1964). Section 121.1158 was redesignated as 21 CFR 135g.41
(35 FR 15372 at 15376) and as Sec. 556.390 (40 FR 13802 at 13956).
8. Methylprednisolone (Sec. 556.400). In 1970, FDA established a
tolerance for methylprednisolone in milk of dairy animals at Sec.
135g.67 (21 CFR 135g.67) incidental to the approval of an FAP for a
combination drug, antibiotic/steroid intramammary infusion (35 FR 12332
at 12333). Section 135g.67 was redesignated as Sec. 556.400 (40 FR
13802 at 13956).
9. Prednisolone (Sec. 556.520). In 1964, FDA established a
tolerance for prednisolone in milk of dairy animals at Sec. 121.1147
(21 CFR 121.1147) incidental to the approval of an FAP for a
combination drug, antibiotic intramammary infusion (29 FR 3393, March
14, 1964). Section 121.1147 was redesignated as 21 CFR 135g.37 (35 FR
15372 at 15376) and as Sec. 556.520 (40 FR 13802 at 13956).
10. Prednisone (Sec. 556.530). In 1964, FDA established a
tolerance for prednisone in milk of dairy animals at Sec. 121.1157 (21
CFR 121.1157) incidental to the approval of an FAP for a combination
drug, antibiotic intramammary infusion (29 FR 14624). Section 121.1157
was redesignated as 21 CFR 135g.40 (35 FR 15372 at 15376) and as Sec.
556.530 (40 FR 13802 at 13956).
11. Propylparaben (Sec. 556.550). In 1964, FDA established a
tolerance for propylparaben in milk of dairy animals at Sec. 121.1159
incidental to the approval of an FAP for a combination drug, antibiotic
intramammary infusion (29 FR 14624). Section 121.1159 was redesignated
as 21 CFR 135g.42 (35 FR 15372 at 15376) and as Sec. 556.550 (40 FR
13802 at 13956).
12. Salicylic acid (Sec. 556.590). In 2005, FDA acknowledged the
voluntary withdrawal of approval of salicylic acid for use in cattle
under NADA 010-481 and revoked 21 CFR 529.2090 (70 FR 50181, August 26,
2005), but did not remove the associated tolerance.
At this time, FDA is revoking the tolerances for 2-acetylamino-5-
nitrothiazole, buquinolate, chlorobutanol, estradiol in lamb,
ethylenediamine, furazolidone, hydrocortisone, methylparaben,
methylprednisolone, prednisolone, prednisone, progesterone in lamb,
propylparaben, and salicylic acid. Accordingly, Sec. Sec. 556.20,
556.140, 556.270, 556.290, 556.320, 556.390, 556.400, 556.520, 556.530,
556.550, and 556.590 are being removed, and Sec. Sec. 556.240 and
556.540 are being amended to reflect the revoked tolerances.
Also, FDA is amending the animal drug regulations in Sec. Sec.
556.283 and 556.286 to cross reference an approved combination drug
injectable solution containing florfenicol and flunixin (75 FR 1274,
January 11, 2010). FDA is further amending Sec. 556.286 to reflect the
marker residue in milk for residues of flunixin meglumine. This action
is being taken to comply with section. 512(i) of the FD&C Act and 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.
Sec. 556.20 [Removed]
0
2. Remove Sec. 556.20.
Sec. 556.140 [Removed]
0
3. Remove Sec. 556.140.
Sec. 556.240 [Amended]
0
4. In Sec. 556.240, remove and reserve paragraph (b).
Sec. 556.270 [Removed]
0
5. Remove Sec. 556.270.
0
6. Revise Sec. 556.283 to read as follows:
Sec. 556.283 Florfenicol.
(a) Acceptable daily intake (ADI). The ADI for total residues of
florfenicol is 10 micrograms per kilogram of body weight per day.
(b) Tolerances--(1) Cattle--(i) Liver (the target tissue). The
tolerance for florfenicol amine (the marker residue) is 3.7 parts per
million (ppm).
(ii) Muscle. The tolerance for florfenicol amine (the marker
residue) is 0.3 ppm.
(2) Swine--(i) Liver (the target tissue). The tolerance for parent
florfenicol (the marker residue) is 2.5 ppm.
(ii) Muscle. The tolerance for parent florfenicol (the marker
residue) is 0.2 ppm.
(3) Catfish. The tolerance for florfenicol amine (the marker
residue) in muscle (the target tissue) is 1 ppm.
(4) Salmonids. The tolerance for florfenicol amine (the marker
residue) in muscle/skin (the target tissues) is 1 ppm.
(c) Related conditions of use. See Sec. Sec. 520.955, 522.955,
522.956, and 558.261 of this chapter.
0
7. In Sec. 556.286, revise paragraphs (b)(1)(iii) and (c) to read as
follows:
Sec. 556.286 Flunixin.
* * * * *
(b) * * *
(1) * * *
(iii) Milk: 2 ppb 5-hydroxy flunixin.
* * * * *
(c) Related conditions of use. See Sec. Sec. 522.956 and 522.970
of this chapter.
Sec. 556.290 [Removed]
0
8. Remove Sec. 556.290.
Sec. 556.320 [Removed]
0
9. Remove Sec. 556.320.
Sec. 556.390 [Removed]
0
10. Remove Sec. 556.390.
Sec. 556.400 [Removed]
0
11. Remove Sec. 556.400.
Sec. 556.520 [Removed]
0
12. Remove Sec. 556.520.
Sec. 556.530 [Removed]
0
13. Remove Sec. 556.530.
Sec. 556.540 [Amended]
0
14. In Sec. 556.540, remove and reserve paragraph (b).
Sec. 556.550 [Removed]
0
15. Remove Sec. 556.550.
Sec. 556.590 [Removed]
0
16. Remove Sec. 556.590.
Dated: March 17, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-6796 Filed 3-22-11; 8:45 am]
BILLING CODE 4160-01-P
