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, 

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approval has been withdrawn for the 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-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, 

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 


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Federal Register / Vol. 76, No. 56 / Wednesday, March 23, 2011 / Rules and Regulations 16291 

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-5- 

nitrothiazole, buquinolate, 

chlorobutanol, estradiol in lamb, 

ethylenediamine, furazolidone, 

hydrocortisone, methylparaben, 

methylprednisolone, prednisolone, 

prednisone, progesterone in lamb, 

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 [Removed] 

■ 2. Remove § 556.20. 

§ 556.140 [Removed] 

■ 3. Remove § 556.140. 

§ 556.240 [Amended] 

■ 4. In § 556.240, remove and reserve 

paragraph (b). 

§ 556.270 [Removed] 

■ 5. Remove § 556.270. 

■ 6. Revise § 556.283 to read as follows: 

§ 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 

§§ 520.955, 522.955, 522.956, and 

558.261 of this chapter. 

■ 7. In § 556.286, revise paragraphs 

(b)(1)(iii) and (c) to read as follows: 

§ 556.286 Flunixin. 

* * * * * 

(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] 

■ 8. Remove § 556.290. 

§ 556.320 [Removed] 

■ 9. Remove § 556.320. 

§ 556.390 [Removed] 

■ 10. Remove § 556.390. 

§ 556.400 [Removed] 

■ 11. Remove § 556.400. 

§ 556.520 [Removed] 

■ 12. Remove § 556.520. 

§ 556.530 [Removed] 

■ 13. Remove § 556.530. 

§ 556.540 [Amended] 

■ 14. In § 556.540, remove and reserve 

paragraph (b). 

§ 556.550 [Removed] 

■ 15. Remove § 556.550. 

§ 556.590 [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 


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