New Animal Drugs for Use in Animal Feed; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Applications
Federal Register, Volume 81 Issue 248 (Tuesday, December 27, 2016)
Federal Register Volume 81, Number 248 (Tuesday, December 27, 2016)
Rules and Regulations
Pages 94991-95025
From the Federal Register Online via the Government Publishing Office www.gpo.gov
FR Doc No: 2016-31083
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 556 and 558
Docket No. FDA-2016-N-0002
New Animal Drugs for Use in Animal Feed; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Applications
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 reflect approval of 71 supplemental new animal drug applications (NADAs) and 35 supplemental abbreviated new animal drug applications (ANADAs) for revised labeling reflecting a change in marketing status from over-the-counter (OTC) use to use by veterinary feed directive (VFD) for antimicrobial drugs of importance to human medicine administered to food-producing animals in medicated feed. Where applicable, FDA is also withdrawing approval of those parts of the NADAs that pertain to use of these antimicrobial drugs for growth promotion indications. These actions are being taken at the sponsors' requests because these particular medicated feeds will no longer be manufactured or marketed. These applications were submitted in voluntary compliance with the goals of FDA Center for Veterinary Medicine's (CVM's) Judicious Use Initiative. In addition, the animal drug regulations are being amended to reflect the voluntary withdrawal of approval of certain entire NADAs and ANADAs that were affected by this initiative. The animal drug regulations are also being amended to reflect several non-substantive changes in format. These technical amendments are being made to improve the consistency and readability of the regulations.
DATES: This rule is effective December 30, 2016.
FOR FURTHER INFORMATION CONTACT: George K. Haibel, Center for Veterinary Medicine (HFV-6), Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 240-402-5689, george.haibel@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
-
Supplemental Approval of Revised Labeling and Withdrawal of Approval of Portions of NADAs Pertaining to Production Indications
FDA is amending the animal drug regulations to reflect approval of 71 supplemental NADAs and 35 supplemental ANADAs for revised labeling reflecting a change in marketing status from OTC use to use by VFD for antimicrobial drugs of importance to human medicine administered to food-producing animals in medicated feed. Where applicable, FDA is also withdrawing approval of those parts of the NADAs that pertain to use of these antimicrobial drugs for growth promotion indications. These actions are being taken at the sponsors' requests because these particular medicated feeds will no longer be manufactured or marketed.
These applications were identified as being affected by guidance for industry (GFI) #213, ``New Animal Drugs and New Animal Drug Combination Products Administered in or on Medicated Feed or Drinking Water of Food-Producing Animals: Recommendations for Drug Sponsors for Voluntarily Aligning Product Use Conditions with GFI #209'', December 2013 (http://www.fda.gov/downloads/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/UCM299624.pdf). Their change to VFD marketing status is consistent with FDA CVM's initiative for the Judicious Use of Antimicrobials.
The animal drug regulations for medicated feeds are also being amended to reflect several non-substantive changes in format. These technical amendments are being made to improve the consistency and readability of the regulations.
The affected applications for Type A medicated articles for which supplemental applications with revised labeling were approved follow:
------------------------------------------------------------------------
File No. Animal drug product Sponsor
------------------------------------------------------------------------
006-391............. S.Q. 40% Huvepharma EOOD, 5th
(sulfaquinoxaline) Type Floor, 3A Nikolay
A Medicated Article. Haytov Str., 1113
Sophia, Bulgaria
(Huvepharma EOOD).
008-804............. TM-50 or TM-100 Phibro Animal Health
(oxytetracycline) Type Corp., GlenPointe
A Medicated Article. Centre East, 3d Floor,
300 Frank W. Burr
Blvd., Suite 21,
Teaneck, NJ 07666
(Phibro Animal Health
Corp.).
010-092............. GALLIMYCIN-100P Cross Vetpharm Group
(erythromycin) Type A Ltd., Broomhill Rd.,
Medicated Article. Tallaght, Dublin 24,
Ireland (Cross Vetpharm
Group Ltd.).
010-918............. HYGROMIX 8 (hygromycin Elanco US Inc., 2500
B) Type A Medicated Innovation Way,
Article. Greenfield, IN 46140
(Elanco US Inc.).
012-491............. TYLAN (tylosin) Type A Elanco US Inc.
Medicated Article.
033-950............. Sulfamerazine In Fish Zoetis Inc., 333 Portage
Grade. St., Kalamazoo, MI
49007 (Zoetis Inc.).
035-688............. AUREOMIX S 40/40 Zoetis Inc.
(chlortetracycline and
sulfamethazine)
Granular Type A
Medicated Article.
035-805............. AUREO S 700 Zoetis Inc.
(chlortetracycline and
sulfamethazine)
Granular Type A
Medicated Article.
038-439............. TERRAMYCIN 200 Phibro Animal Health
(oxytetracycline) for Corp.
Fish Type A Medicated
Article.
040-209............. ROFENAID 40 Zoetis Inc.
(sulfadimethoxine and
ormetoprim) Type A
Medicated Article.
Page 94992
041-275............. TYLAN 40 Sulfa-G Elanco US Inc.
(tylosin and
sulfamethazine) Type A
Medicated Article.
041-647............. AUREOMIX S 700-A Zoetis Inc.
(chlortetracycline and
sulfamethazine) Type A
Medicated Article.
041-648............. AUREOMIX S 700-D Zoetis Inc.
(chlortetracycline and
sulfamethazine) Type A
Medicated Article.
041-649............. AUREOMIX S 700-G Zoetis Inc.
(chlortetracycline and
sulfamethazine) Type A
Medicated Article.
041-650............. AUREOMIX S 700-E Zoetis Inc.
(chlortetracycline and
sulfamethazine) Type A
Medicated Article.
041-651............. AUREOMIX S 700-F Zoetis Inc.
(chlortetracycline and
sulfamethazine) Type A
Medicated Article.
041-652............. AUREOMIX S 700-C-2 Zoetis Inc.
(chlortetracycline and
sulfamethazine) Type A
Medicated Article.
041-653............. AUREOMIX S 700-B Zoetis Inc.
(chlortetracycline and
sulfamethazine) Type A
Medicated Article.
041-654............. AUREOMIX S 700-H Zoetis Inc.
(chlortetracycline and
sulfamethazine) Type A
Medicated Article.
046-415............. Tylosin Type A Medicated Zoetis Inc.
Article.
046-699............. CHLORMAX Zoetis Inc.
(chlortetracycline)
Type A Medicated
Article.
048-480............. CHLORATET Pharmgate LLC, 1015
(chlortetracycline) Ashes Dr., Suite 102,
Type A Medicated Wilmington, NC 28405
Article. (Pharmgate LLC).
048-761............. AUREOMYCIN Zoetis Inc.
(chlortetracycline)
Type A Medicated
Article.
049-287............. CHLORACHEL Zoetis Inc.
(chlortetracycline)Type
A Medicated Article.
091-749............. TYLAN 40 Plus Sulfa-G Zoetis Inc.
(tylosin and
sulfamethazine) Type A
Medicated Article.
092-286............. CLTC-50 MR Phibro Animal Health
(chlortetracycline) Corp.
Type A Medicated
Article.
092-287............. CLTC 100 MR Phibro Animal Health
(chlortetracycline) Corp.
Type A Medicated
Article.
094-975............. NEO-TERRAMYCIN 100/100 Phibro Animal Health
(oxytetracycline and Corp.
neomycin) Type A
Medicated Article.
095-143............. TERRAMYCIN 10, 30, 50, Phibro Animal Health
100, or 200 Corp.
(oxytetracycline) Type
A Medicated Article.
097-505............. LINCOMIX 20 (lincomycin) Zoetis Inc.
Type A Medicated
Article.
098-431............. TYLAN 10 (tylosin) Phibro Animal Health
Premix Type A Medicated Corp.
Article.
100-901............. PFICHLOR 100S Zoetis Inc.
(chlortetracycline)
Milk Replacer Type A
Medicated Article.
125-933............. ROMET-30 (ormetoprim and Pharmaq AS.
sulfadimethoxine) Type
A Medicated Article.
126-050............. APRALAN 75 (apramycin) Elanco US Inc.
Type A Medicated
Article.
138-934............. PENNCHLOR S 40/40 Pharmgate LLC.
(chlortetracycline and
sulfamethazine) Type A
medicated article.
138-935............. PENNCHLOR 100 MR Pharmgate LLC.
(chlortetracycline)
Type A Medicated
Article.
138-938............. PENNOX 50, 100, or 200 Pharmgate LLC.
Hi-Flo, or 100-MR
(oxytetracycline) Type
A Medicated Article.
138-939............. NEO-OXY 100/100 MR Pharmgate LLC.
(oxytetracycline and
neomycin) Type A
Medicated Article.
140-976............. NEOMIX 325 Milk Replacer Zoetis Inc.
(neomycin) Type A
Medicated Article.
200-314............. PENNCHLOR S Pharmgate LLC.
(chlortetracycline and
sulfamethazine) Type A
Medicated Article.
200-484............. TYLOVET 100 (tylosin) Huvepharma.
Type A Medicated
Article.
200-510............. DERACIN 100 Pharmgate LLC.
(chlortetracycline)
Type A Medicated
Article.
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The affected applications for manufacturing combination drug medicated feeds follow:
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File No. Animal drug product Sponsor
------------------------------------------------------------------------
036-361................ CTC Sodium Sulfate Zoetis Inc., 333
(chlortetracycline and Portage St.,
sodium sulfate)/AMPROL Kalamazoo, MI 49007
PLUS (amprolium and (Zoetis Inc.).
ethopabate).
045-444................ CHLORMAX Zoetis Inc.
(chlortetracycline)/
DECCOX (decoquinate).
046-209................ CTC (chlortetracycline)/ Huvepharma EOOD, 5th
COYDEN (clopidol). Floor, 3A Nikolay
Haytov Str., 1113
Sophia, Bulgaria
(Huvepharma EOOD).
092-507................ AUREOMYCIN Zoetis Inc.
(chlortetracycline)/
ROBENZ (robenidine).
099-006................ TERRAMYCIN Phibro Animal Health
(oxytetracycline)/ Corp., GlenPointe
COBAN (monensin). Centre East, 3d
Floor, 300 Frank W.
Burr Blvd., Suite 21,
Teaneck, NJ 07666
(Phibro Animal Health
Corp.).
101-666................ TERRAMYCIN Phibro Animal Health
(oxytetracycline)/ Corp.
ROBENZ (robenidine).
Page 94993
104-646................ TYLAN (tylosin)/ Elanco US Inc., 2500
RUMENSIN (monensin). Innovation Way,
Greenfield, IN 46140
(Elanco US Inc.).
110-047................ TYLAN (tylosin)/ Phibro Animal Health
BANMINTH (pyrantel). Corp.
116-044................ LINCOMIX (lincomycin)/ Phibro Animal Health
BANMINTH (pyrantel). Corp.
121-553................ AUREOMYCIN Zoetis Inc.
(chlortetracycline)/
COBAN (monensin).
138-870................ TYLAN (tylosin)/ Zoetis Inc.
RUMENSIN (monensin)/
MGA (melengestrol).
138-941................ LINCOMIX (lincomycin)/ Zoetis Inc.
BANMINTH (pyrantel).
138-992................ TYLAN (tylosin)/BOVATEC Zoetis Inc.
(lasalocid)/MGA
(melengestrol).
138-995................ TYLAN (tylosin)/MGA Zoetis Inc.
(melengestrol).
139-192................ TYLAN (tylosin)/MGA Zoetis Inc.
(melengestrol).
140-448................ TERRAMYCIN Phibro Animal Health
(oxytetracycline)/BIO- Corp.
COX (salinomycin).
140-859................ AUREOMYCIN Zoetis Inc.
(chlortetracycline)/
BIO-COX (salinomycin).
140-954................ LINCOMIX (lincomycin)/ Intervet, Inc.
SAFE-GUARD
(fenbendazole).
141-011................ CTC (chlortetracycline)/ Elanco US Inc.
DENAGARD (tiamulin).
141-054................ LINCOMIX (lincomycin)/ Merial, Inc., 3239
IVOMEC (ivermectin). Satellite Blvd.,
Bldg. 500, Duluth, GA
30096-4640.
141-059................ CHLORMAX Zoetis Inc.
(chlortetracycline)/
BMD (bacitracin).
141-147................ CHLORMAX Zoetis Inc.
(chlortetracycline)/
DECCOX (decoquinate).
141-149................ TYLAN (tylosin)/ Zoetis Inc.
RUMENSIN (monensin)/
DECCOX (decoquinate).
141-172................ TYLAN (tylosin)/PAYLEAN Elanco US Inc.
(ractopamine).
141-185................ AUREOMYCIN Zoetis Inc.
(chlortetracycline)/
DECCOX (decoquinate).
141-201................ AUREOMYCIN Zoetis Inc.
(chlortetracycline)/
CATTLYST (laidlomycin).
141-211................ TERRAMYCIN Phibro Animal Health
(oxytetracycline)/ Corp.
(carbadox).
141-224................ TYLAN (tylosin)/ Elanco US Inc.
RUMENSIN (monensin)/
OPTAFLEXX
(ractopamine).
141-233................ TYLAN (tylosin)/ Elanco US Inc.
RUMENSIN (monensin)/
OPTAFLEXX
(ractopamine)/MGA
(melengestrol).
141-250................ AUREOMYCIN Zoetis Inc.
(chlortetracycline)/
BOVATEC (lasalocid).
141-276................ TYLAN (tylosin)/ Intervet, Inc., 2
RUMENSIN (monensin)/ Giralda Farms,
ZILMAX (zilpaterol). Madison, NJ 07940
(Intervet, Inc.).
141-280................ TYLAN (tylosin)/ Intervet, Inc.
RUMENSIN (monensin)/
ZILMAX (zilpaterol)/
MGA (melengestrol).
200-095................ AUREOMYCIN Huvepharma EOOD.
(chlortetracycline)/
SACOX (salinomycin).
200-096................ TERRAMYCIN Huvepharma EOOD.
(oxytetracycline)/
SACOX (salinomycin).
200-242................ AUREOMYCIN Zoetis Inc.
(chlortetracycline)/
BMD (bacitracin).
200-261................ CHLORMAX Zoetis Inc.
(chlortetracycline)/
BIO-COX (salinomycin).
200-262................ CHLORMAX Zoetis Inc.
(chlortetracycline)/
SACOX (salinomycin).
200-263................ CHLORMAX Zoetis Inc.
(chlortetracycline)/
COBAN (monensin).
200-354................ PENNCHLOR Pharmgate LLC, 1015
(chlortetracycline)/ Ashes Dr., Suite 102,
COBAN (monensin). Wilmington, NC 28405
(Pharmgate LLC).
200-356................ PENNCHLOR Pharmgate LLC.
(chlortetracycline)/
DENAGARD (tiamulin).
200-357................ PENNCHLOR Pharmgate LLC.
(chlortetracycline)/
BIO-COX (salinomycin).
200-358................ PENNCHLOR Pharmgate LLC.
(chlortetracycline)/
BMD (bacitracin).
200-359................ PENNCHLOR Pharmgate LLC.
(chlortetracycline)/
DECCOX (decoquinate).
200-375................ TYLAN (tylosin)/ Elanco US Inc.
RUMENSIN (monensin)/
HEIFERMAX
(melengestrol).
200-424................ TYLAN (tylosin)/ Elanco US Inc.
RUMENSIN (monensin)/
OPTAFLEXX
(ractopamine)/
HEIFERMAX
(melengestrol).
200-427................ TYLAN (tylosin)/ Elanco US Inc.
HEIFERMAX 500
(melengestrol) Liquid.
200-430................ TYLAN (tylosin)/BOVATEC Elanco US Inc.
(lasalocid)/HEIFERMAX
500 (melengestrol)
Liquid.
200-480................ TYLAN (tylosin)/ Elanco US Inc.
RUMENSIN (monensin)/
ZILMAX (zilpaterol)/
HEIFERMAX 500
(melengestrol).
200-530................ TYLOVET (tylosin)/ Huvepharma EOOD.
PAYLEAN (ractopamine).
200-531................ TYLOVET (tylosin)/ Huvepharma EOOD.
RUMENSIN (monensin).
200-532................ TYLOVET (tylosin)/MGA Huvepharma EOOD.
(melengestrol).
200-533................ TYLOVET (tylosin)/ Huvepharma EOOD.
RUMENSIN (monensin)/
DECCOX (decoquinate).
200-534................ TYLOVET (tylosin)/ Huvepharma EOOD.
RUMENSIN (monensin)/
MGA (melengestrol).
200-535................ TYLOVET (tylosin)/ Huvepharma EOOD.
BOVATEC (lasalocid)/
MGA (melengestrol).
200-544................ TYLOVET (tylosin)/ Huvepharma EOOD.
RUMENSIN (monensin)/
ZILMAX (zilpaterol)/
MGA (melengestrol).
200-547................ TYLOVET (tylosin)/ Huvepharma EOOD.
RUMENSIN (monensin)/
ZILMAX (zilpaterol).
200-558................ TYLAN (tylosin)/ENGAIN Zoetis Inc.
(ractopamine).
200-561................ TYLAN (tylosin)/ Zoetis Inc.
RUMENSIN (monensin)/
ACTOGAIN (ractopamine).
200-562................ TYLAN (tylosin)/ Zoetis Inc.
RUMENSIN (monensin)/
ACTOGAIN (ractopamine).
200-566................ TYLOVET (tylosin)/ Huvepharma EOOD.
RUMENSIN (monensin).
200-567................ TYLOVET (tylosin)/ Huvepharma EOOD.
RUMENSIN (monensin).
Page 94994
200-583................ TYLOVET (tylosin)/ Zoetis Inc.
RUMENSIN (monensin)/
ACTOGAIN (ractopamine)/
MGA (melengestrol).
200-584................ TYLOVET (tylosin)/ Zoetis Inc.
ENGAIN (ractopamine).
200-585................ TYLOVET (tylosin)/ Zoetis Inc.
RUMENSIN (monensin)/
ACTOGAIN (ractopamine).
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The animal drug regulations are also being amended to reflect several non-substantive changes in format. These technical amendments are being made to improve the consistency and readability of the regulations.
Elsewhere in this issue of the Federal Register, FDA is amending the animal drug regulations to reflect approval of similar supplemental NADAs and ANADAs changing the marketing status of antimicrobial drugs administered to food-producing animals in medicated water.
-
Changes of Sponsorship
Elanco US Inc., 2500 Innovation Way, Greenfield, IN 46140 has informed FDA that it has transferred ownership of, and all rights and interest in, NADA 141-110, providing for the manufacture of combination drug medicated turkey feeds containing STAFAC (virginiamycin) and COBAN (monensin) to Phibro Animal Health Corp., GlenPointe Centre East, 3d Floor, 300 Frank W. Burr Blvd., Suite 21, Teaneck, NJ 07666. As provided in the regulatory text of this document, the animal drug regulations are amended to reflect this change of sponsorship.
-
Withdrawals of Approval
In addition, approval of the following applications for medicated feeds containing antimicrobial drugs of importance to human medicine administered to food-producing animals is being withdrawn at the sponsors' requests because the products are no longer manufactured or marketed:
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File No. Product name Sponsor
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034-085................ LINCOMIX (lincomycin Zoetis Inc., 333
hydrochloride Portage St.,
monohydrate) Type A Kalamazoo, MI 49007
Medicated Article. (Zoetis Inc.).
035-287................ OM-5 Premix Phibro Animal Health
(oleandomycin) Type A Corp., GlenPointe
Medicated Article. Centre East, 3d
Floor, 300 Frank W.
Burr Blvd., Suite 21,
Teaneck, NJ 07666
(Phibro Animal Health
Corp.).
046-668................ Penicillin G Procaine Phibro Animal Health
50% Type A Medicated Corp.
Article.
091-668................ CHLORMAX-SP 500 Zoetis Inc.
(chlortetracycline,
sulfamethazine,
penicillin G procaine)
Type A Medicated
Article.
108-116................ LINCOMIX (lincomycin)/ Phibro Animal Health
NICARB (nicarbazin). Corp.
133-334................ Virginiamycin Type A Zoetis Inc.
Medicated Article.
139-473................ STAFAC (virginiamycin)/ Huvepharma EOOD, 5th
STENEROL (halofuginone Floor, 3A Nikolay
hydrobromide). Haytov Str., 1113
Sophia, Bulgaria
(Huvepharma EOOD).
140-340................ LINCOMIX (lincomycin)/ Huvepharma EOOD.
STENOROL (halofuginone
hydrobromide).
140-443................ HYGROMIX 1.6 Zoetis Inc.
(hygromycin B) Type A
Medicated Article.
140-947................ LINCOMIX (lincomycin)/ Elanco US Inc., 2500
MAXIBAN (narasin and Innovation Way,
nicarbazin). Greenfield, IN 46140
(Elanco US Inc.).
141-090................ STAFAC (virginiamycin)/ Huvepharma EOOD.
CLINICOX (diclazuril).
200-171................ LINCOMIX (lincomycin)/ Planalquimica
NICARMIX (nicarbazin). Industrial Ltda., Rua
das Magnolias nr.
2405, Jardim das
Bandeiras, CEP 13053-
120, Campinas, Sao
Paulo, Brazil.
200-569................ TYLAN (tylosin)/SACOX Huvepharma EOOD.
(salinomycin).
200-570................ TYLOVET 100 (tylosin)/ Huvepharma EOOD.
BIO-COX (salinomycin).
200-580................ TYLOVET 100 (tylosin)/ Huvepharma EOOD.
SACOX (salinomycin).
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Elsewhere in this issue of the Federal Register, FDA gave notice that approval of NADAs 034-085, 035-287, 046-668, 091-668, 108-116, 133-334, 139-473, 140-340, 140-443, 140-947, and 141-090, and ANADAs 200-171, 200-569, 200-570, and 200-580, and all supplements and amendments thereto, is withdrawn, effective January 6, 2017. As provided in the regulatory text of this document, the animal drug regulations are amended to reflect these voluntary withdrawals of approval.
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
21 CFR Part 556
Animal drugs, Foods.
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 556 and 558 are amended as follows:
PART 556--TOLERANCES FOR RESIDUES OF NEW ANIMAL DRUGS IN FOOD
0
1. The authority citation for part 556 continues to read as follows:
Authority: 21 U.S.C. 342, 360b, 371.
Sec. 556.480 Removed
0
2. Remove Sec. 556.480.
PART 558--NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS
0
3. The authority citation for part 558 continues to read as follows:
Authority: 21 U.S.C. 354, 360b, 360ccc, 360ccc-1, 371.
Page 94995
0
4. In Sec. 558.4, in paragraph (d), in the Category I table, in the column headings for ``Assay limits \1\ percent type A'' and ``Assay limits percent \1\ type B/C \2\'', remove ``type'' and in its place add ``Type'', and remove the row entries for ``Erythromycin (thiocyanate salt)'' and ``Oleandomycin''; and in the Category II table, alphabetically add an entry for ``Erythromycin'' to read as follows:
Sec. 558.4 Requirement of a medicated feed mill license.
* * * * *
(d) * * *
Category II
----------------------------------------------------------------------------------------------------------------
Assay limits Assay limits
Drug percent \1\ Type B maximum (100x) percent \1\
Type A Type B/C \2\
----------------------------------------------------------------------------------------------------------------
* * * * * * *
Erythromycin............................... 85-115 4.625 g/lb (1.02%)................. 75-125
* * * * * * *
----------------------------------------------------------------------------------------------------------------
* * * * *
0
5. In Sec. 558.58, remove and reserve paragraphs (e)(2), (7), and (8); remove paragraphs (e)(10) and (11); and add paragraph (f) to read as follows:
Sec. 558.58 Amprolium and ethopabate.
* * * * *
(f) Amprolium and ethopabate may also be used in combination with:
(1) Reserved
(2) Reserved
(3) Chlortetracycline as in Sec. 558.128.
(4) Lincomycin as in Sec. 558.325.
(5) Virginiamycin as in Sec. 558.635.
0
6. Revise Sec. 558.59 to read as follows:
Sec. 558.59 Apramycin.
(a) Specifications. Type A articles containing 75 grams apramycin (as apramycin sulfate) per pound.
(b) Sponsor. See No. 058198 in Sec. 510.600(c) of this chapter.
(c) Related tolerances. See Sec. 556.52 of this chapter.
(d) Conditions of use in swine--
----------------------------------------------------------------------------------------------------------------
Combination in
Apramycin grams/ton grams/ton Indications for use Limitations Sponsor
----------------------------------------------------------------------------------------------------------------
(1) 150.......................... .............. For control of porcine Feed as the sole ration 058198
colibacillosis for 14 consecutive
(weanling pig scours) days. Withdraw 28 days
caused by susceptible before slaughter.
strains of Escherichia
coli.
(2) Reserved...................
----------------------------------------------------------------------------------------------------------------
0
7. In Sec. 558.76, redesignate paragraphs (e)(2)(iii) through (xvi) as paragraphs (e)(2)(iv) through (xvii); and add new paragraph (e)(2)(iii) to read as follows:
Sec. 558.76 Bacitracin methylenedisalicylate.
* * * * *
(e) * * *
(2) * * *
(iii) Chlortetracycline as in Sec. 558.128.
* * * * *
0
8. Revise Sec. 558.128 to read as follows:
Sec. 558.128 Chlortetracycline.
(a) Specifications. Type A medicated articles containing either chlortetracycline calcium complex equivalent to chlortetracycline hydrochloride, or for products intended for use in milk replacer, chlortetracycline hydrochloride.
(b) Approvals. See sponsors in Sec. 510.600(c) of this chapter for use as in paragraph (e) of this section.
(1) Nos. 054771: 50, 65, or 100 grams per pound (g/lb) Type A medicated article.
(2) No. 066104: 10, 20, 30, 50, 70, or 100 g/lb of Type A medicated article.
(3) No. 069254: 50, 90, or 100 g/lb of Type A medicated article.
(c) Related tolerances. See Sec. 556.150 of this chapter.
(d) Special considerations--(1) Federal law restricts medicated feed containing this veterinary feed directive (VFD) drug to use by or on the order of a licensed veterinarian. See Sec. 558.6 for additional requirements.
(2) The expiration date of VFDs for chlortetracycline medicated feeds must not exceed 6 months from the date of issuance. VFDs for chlortetracycline shall not be refilled.
(3) In milk replacers or starter feed; include on labeling the warning: ``A withdrawal period has not been established for this product in preruminating calves. Do not use in calves to be processed for veal.''
(4) Manufacture for use in free-choice feeds as in paragraph (e)(4)(iii) of this section must conform to Sec. 510.455 of this chapter.
(5) When manufactured for use as in paragraph (e)(5)(iii) of this section, include on labeling the warning: ``Psittacosis, avian chlamydiosis, or ornithosis is a reportable communicable disease, transmissible between wild and domestic birds, other animals, and man. Contact appropriate public health and regulatory officials.''
(e) Conditions of use--(1) Chickens. It is used as follows:
----------------------------------------------------------------------------------------------------------------
Combination in
Chlortetracycline amount grams/ton Indications for use Limitations Sponsor
----------------------------------------------------------------------------------------------------------------
(i) 100 to 200 g/ton....... .................. Chickens: For control Feed continuously for 054771 066104
of infectious 7 to 14 days. Do not 069254
synovitis caused by feed to chickens
Mycoplasma synoviae producing eggs for
susceptible to human consumption.
chlortetracycline.
Page 94996
(ii) 100 to 200 g/ton...... Clopidol, 113.5... Broiler and replacement Feed continuously as 016592
chickens: As an aid in the sole ration from
the prevention of the time chicks are
coccidiosis caused by placed in floor pens
Eimeria tenella, E. for 7 to 14 days. Do
necatrix, E. not feed to chickens
acervulina, E. maxima, over 16 weeks of age.
E. mivati, and E. Do not feed to
brunetti; and for chickens producing
control of infectious eggs for human
synovitis caused by M. consumption.
synoviae susceptible Chlortetracycline as
to chlortetracycline. provided by No.
054771; clopidol as
provided by No.
016592 in Sec.
510.600(c) of this
chapter.
(iii) 100 to 200 g/ton..... Decoquinate, 27.2. Chickens: For Feed continuously for 054771
prevention of 7 to 14 days.
coccidiosis caused by Bentonite should not
Eimeria tenella, E. be used in
necatrix, E. mivati, decoquinate feeds. Do
E. acervulina, E. not feed to chickens
maxima, and E. producing eggs for
brunetti; and for human consumption.
control of infectious Chlortetracycline and
synovitis caused by M, decoquinate as
synoviae susceptible provided by No.
to chlortetracycline. 054771 in Sec.
510.600(c) of this
chapter.
(iv) 100 g/ton............. Robenidine, 30.... Broiler and fryer Feed continuously as 054771
chickens: As an aid in sole ration. Do not
the prevention of use this product in
coccidiosis caused by feeds conta.
E. mivati, E. Chlortetracycline and
brunetti, E. tenella, robenidine as
E. acervulina, E. provided by No.
maxima, and E. 054771 in Sec.
necatrix; as an aid in 510.600(c) of this
the control of chronic chapter.
respiratory disease
(CRD) caused by
Mycoplasma
gallisepticum
susceptible to
chlortetracycline; and
as an aid in the
control of infectious
synovitis caused by M.
synoviae susceptible
to chlortetracycline.
(v) 200 to 400 g/ton....... .................. Chickens: For the Feed continuously for 054771 066104
control of chronic 7 to 14 days. Do not 069254
respiratory disease feed to chickens
(CRD) and air sac producing eggs for
infection caused by M. human consumption.
gallisepticum and
Escherichia coli
susceptible to
chlortetracycline.
(vi) 200 g/ton............. Amprolium, 227 and For chickens where Use in low calcium 054771
ethopabate, 3.6. immunity to feed containing 0.8%
coccidiosis is not dietary calcium and
desired: For 1.5% sodium sulfate;
prevention of feed continuously as
coccidiosis; and for sole ration for 7 to
treatment of chronic 14 days; do not feed
respiratory disease to chickens producing
(CRD) caused by M. eggs for human
gallisepticum consumption.
susceptible to Chlortetracycline as
chlortetracycline. provided by No.
054771; amprolium and
ethopabate as
provided by No.
016592 in Sec.
510.600(c) of this
chapter.
(vii) 200 g/ton............ Decoquinate, 27.2. Broilers: As an aid in Feed continuously as 054771
the prevention of the sole ration for
coccidiosis caused by no more than 8 weeks.
Eimeria tenella, E. Use in low calcium
necatrix, E. feed containing 0.8%
acervulina, E. mivati, dietary calcium.
E. maxima, and E. Bentonite should not
brunetti; and for the be used in
treatment of chronic decoquinate feeds. Do
respiratory disease not feed to chickens
(air sac infection) producing eggs for
and the prevention of human consumption.
synovitis. Chlortetracycline and
decoquinate as
provided by No.
054771 in Sec.
510.600(c) of this
chapter.
(viii) 200 g/ton........... Robenidine 30..... Broiler and fryer Feed continuously as 054771
chickens: As an aid in sole ration. Do not
the prevention of use this product in
coccidiosis caused by feeds containing
E. mivati, E. bentonite. Do not
brunetti, E. tenella, feed to chickens
E. acervulina, E. producing eggs for
maxima, and E. human consumption.
necatrix; as an aid in Withdraw 5 days prior
the control of chronic to slaughter.
respiratory disease Chlortetracycline and
(CRD) caused by M. robenidine as
gallisepticum provided by No.
susceptible to 054771 in Sec.
chlortetracycline; and 510.600(c) of this
as an aid in the chapter.
control of infectious
synovitis caused by M.
synoviae susceptible
to chlortetracycline.
(ix) 500 g/ton............. .................. Chickens: For the 1. Feed for 5 days. To 054771 069254
reduction of mortality sponsor No. 054771
due to E. coli under NADA 048-761
infections susceptible and No. 069254 under
to chlortetracycline. ANADA 200-510: zero
withdrawal time.
2. Feed for 5 days; 054771
withdraw 24 hours 066104
prior to slaughter. 069254
Do not feed to
chickens producing
eggs for human
consumption.
Page 94997
(x) 500 g/ton.............. Monensin, 90 to Chickens: As an aid in Feed for 5 days as the 054771 069254
110. the reduction of sole ration. Do not
mortality due to E. feed to laying
coli infections chickens. Not to be
susceptible to fed continuously for
chlortetracycline; and more than 5 days. Do
as an aid in the not feed to chickens
prevention of over 16 weeks of age.
coccidiosis caused by Withdraw 24 hours
Eimeria tenella, E. before slaughter. See
necatrix, E. Sec. 558.355(d) of
acervulina, E. maxima, this chapter.
E. brunetti, and E. Chlortetracycline as
mivati. provided by No.
054771; monensin as
provided by No.
058198 in Sec.
510.600(c) of this
chapter.
(xi) 500 g/ton............. Robenidine, 30.... Broiler and fryer Feed continuously as 054771
chickens: As an aid in sole ration for up to
the prevention of 5 days. Do not use
coccidiosis caused by this product in feeds
Eimeria mivati, E. containing bentonite.
brunetti, E. tenella, Do not feed to
E. acervulina, E. chickens producing
maxima, and E. eggs for human
necatrix; as an aid in consumption. Withdraw
the reduction of 5 days prior to
mortality due to E. slaughter.
coli susceptible to Chlortetracycline and
chlortetracycline. robenidine as
provided by No.
054771 in Sec.
510.600(c) of this
chapter.
(xii) 500 g/ton............ Salinomycin, 40 to Broiler chickens: As an For use in low calcium 016592 054771
60. aid in the prevention feeds containing 0.8% 069254
of coccidiosis caused calcium. Not approved
by Eimeria tenella, E. for use with pellet
necatrix, E. binders. Not to be
acervulina, E. maxima, fed continuously for
E. brunetti, and E. more than 5 days. Do
mivati; and as an aid not feed to laying
in the reduction of chickens producing
mortality due to E. eggs for human
coli susceptible to consumption. Withdraw
chlortetracycline. 24 hours before
slaughter. May be
fatal if accidentally
fed to adult turkeys
or horses.
Chlortetracycline as
provided by Nos.
054771 or 069254;
salinomycin as
provided by Nos.
054771 or 016592 in
Sec. 510.600(c) of
this chapter.
----------------------------------------------------------------------------------------------------------------
(2) Turkeys. It is used as follows:
----------------------------------------------------------------------------------------------------------------
Combination in
Chlortetracycline amount grams/ton Indications for use Limitations Sponsor
----------------------------------------------------------------------------------------------------------------
(i) 200 g/ton.............. .................. Turkeys: For control of Feed continuously for 054771
infectious synovitis 7 to 14 days. Do not 066104
caused by M. synoviae feed to turkeys 069254
susceptible to producing eggs for
chlortetracycline. human consumption.
(ii) 400 g/ton............. .................. 1. Turkeys: For control Feed continuously for 054771
of hexamitiasis caused 7 to 14 days. Do not 066104
by Hexamita feed to turkeys 069254
meleagridis producing eggs for
susceptible to human consumption.
chlortetracycline.
.................. 2. Turkey poults not ...................... 054771
over 4 weeks of age: 066104
For reduction of 069254
mortality due to
paratyphoid caused by
Salmonella typhimurium
susceptible to
chlortetracycline.
(iii) 25 mg/lb of body .................. Turkeys: For control of Feed continuously for 054771
weight. complicating bacterial 7 to 14 days. Do not 066104
organisms associated feed to turkeys 069254
with bluecomb producing eggs for
(transmissible human consumption.
enteritis; coronaviral
enteritis) susceptible
to chlortetracycline.
----------------------------------------------------------------------------------------------------------------
(3) Swine. It is used as follows:
----------------------------------------------------------------------------------------------------------------
Combination in
Chlortetracycline amount grams/ton Indications for use Limitations Sponsor
----------------------------------------------------------------------------------------------------------------
(i) 50 to 100 g/ton........ .................. Swine: For reducing the ...................... 054771
incidence of cervical 066104
lymphadenitis (jowl 069254
abscesses) caused by
Group E Streptococci
susceptible to
chlortetracycline.
Page 94998
(ii) 400 g/ton............. .................. Breeding swine: For the Feed continuously for 054771
control of not more than 14 days. 066104
leptospirosis 069254
(reducing the
incidence of abortion
and shedding of
leptospirae) caused by
Leptospira pomona
susceptible to
chlortetracycline.
(iii) 10 mg/lb of body .................. Swine: For treatment of Feed approximately 400 054771
weight. bacterial enteritis g/ton, varying with 066104
caused by Escherichia body weight and feed 069254
coli and S. consumption to
choleraesuis and provide 10 mg/lb per
bacterial pneumonia day. Feed for not
caused by Pasteurella more than 14 days.
multocida susceptible Withdraw 5 d prior to
to chlortetracycline; slaughter for sponsor
for the control of No. 069254 in Sec.
porcine proliferative 510.600(c) of this
enteropathies chapter.
(ileitis) caused by
Lawsonia
intracellularis
susceptible to
chlortetracycline.
(iv) 10 mg/lb of body Bacitracin Swine: For treatment of Feed approximately 400 054771
weight. methylenedisalicy bacterial enteritis g/ton, varying with
late, 10 to 30. caused by E. coli and body weight and feed
S. choleraesuis and consumption to
bacterial pneumonia provide 10 mg/lb per
caused by P. multocida day. Feed for not
susceptible to more than 14 days.
chlortetracycline; for
the control of porcine
proliferative
enteropathies
(ileitis) caused by
Lawsonia
intracellularis
susceptible to
chlortetracycline; and
for increased rate of
weight gain and
improved feed
efficiency.
(v) 10 mg/lb of body weight Bacitracin Swine: For treatment of Feed chlortetracycline 069254
methylenedisalicy bacterial enteritis at approximately 400
late, 10 to 30. caused by E. coli and g/ton of feed,
S. choleraesuis and varying with body
bacterial pneumonia weight and food
caused by P. multocida consumption, to
susceptible to provide 10 mg/lb of
chlortetracycline; and body weight. Feed for
for increased rate of not more than 14
weight gain and days. Withdraw 5 d
improved feed prior to slaughter
efficiency. for sponsor No.
069254. Bacitracin
methylenedisalicylate
provided by No.
054771;
chlortetracycline
provided by Nos.
054771 and 069254 in
Sec. 510.600(c) of
this chapter.
(vi) 500 to 4,000 to Tiamulin hydrogen For control of swine Feed continuously as 058198
provide 10 mg/lb of body fumarate, 35. dysentery associated the sole ration for 069254
weight daily. with Brachyspira 14 days. Withdraw
(formerly Serpulina or medicated feed 2 days
Treponema) before slaughter.
hyodysenteriae Tiamulin as provided
susceptible to by Nos. 058198 or
tiamulin and for 069254in Sec.
treatment of swine 510.600(c) of this
bacterial enteritis chapter.
caused by E. coli and
Salmonella
choleraesuis sensitive
to chlortetracycline
and treatment of
bacterial pneumonia
caused by P. multocida
sensitive to
chlortetracycline.
----------------------------------------------------------------------------------------------------------------
(4) Cattle. It is used as follows:
----------------------------------------------------------------------------------------------------------------
Combination in
Chlortetracycline amount grams/ton Indications for use Limitations Sponsor
----------------------------------------------------------------------------------------------------------------
(i) 0.5 mg/lb of body weight ................. Beef cattle (over 700 Withdraw 48 hours 054771
daily. lb): For control of prior to slaughter. 066104
active infection of To sponsor Nos. 069254
anaplasmosis caused 054771 and 069254:
by Anaplasma Zero withdrawal time.
marginale susceptible
to chlortetracycline.
Page 94999
(ii) 25 to 1,100 to provide Lasalocid, 30 to Pasture cattle Feed continuously on 054771
0.5 mg/lb of body weight 600. (slaughter, stocker, a hand-fed basis 0.5
daily. feeder cattle, beef mg chlortetracycline
replacement heifers) per lb. body weight
over 700 pounds: For per day and not less
control of active than 60 mg or more
infection of than 300 mg
anaplasmosis caused lasalocid per head
by A. marginale daily in at least 1
susceptible to pound of feed. Daily
chlortetracycline; lasalocid intakes in
and for increased excess of 200 mg/
rate of weight gain. head/day in pasture
cattle have not been
shown to be more
effective than 200
mg lasalocid/head/
day. Do not allow
horses or other
equines access to
feeds containing
lasalocid. No
withdrawal period is
required. A
withdrawal period
has not been
established for this
product in pre-
ruminating calves.
Do not use in calves
to be processed for
veal. See Sec.
558.311(d) of this
chapter. Lasalocid
as provided by No.
054771 in Sec.
510.600(c) of this
chapter.
(iii) 0.5 to 2.0 mg/lb of body ................. Beef cattle and In free-choice cattle 054771
weight daily. nonlactating dairy feeds such as feed
cattle: As an aid in blocks or salt-
the control of active mineral mixes
infection of manufactured from
anaplsmosis caused by approved Type A
A. marginale articles. See
susceptible to paragraph (d)(4) of
chlortetracycline. this section.
(iv) 10 mg/lb of body weight ................. 1. Calves, beef and Feed approximately 054771 066104
daily. nonlactating dairy 400 g/ton, varying 069254
cattle: For treatment with body weight and
of bacterial feed consumption to
enteritis caused by provide 10 mg/lb per
Escherichia coli and day. Treat for not
bacterial pneumonia more than 5 days. In
caused by Pasteurella feed including milk
multocida organisms replacers withdraw
susceptible to 10 days prior to
chlortetracycline. slaughter. To
sponsor No. 069254:
zero withdrawal
time. See paragraph
(d)(3) of this
section.
2. Calves (up to 250 See paragraph (d)(3) 054771
lb): For the of this section. 066104
treatment of 069254
bacterial enteritis
caused by E. coli
susceptible to
chlortetracycline.
(v) 10 mg/lb of body weight Laidlomycin, 5... Cattle fed in Feed continuously at 054771
daily. confinement for a rate of 30 to 75
slaughter: For mg laidlomycin
treatment of propionate potassium
bacterial enteritis per head per day for
caused by E. coli and not more than 5
bacterial pneumonia days. A withdrawal
caused by P. period has not been
multocida organisms established for this
susceptible to product in pre-
chlortetracycline; ruminating calves.
and for increased Do not use in calves
rate of weight and to be processed for
improved feed veal. See Sec.
efficiency. 558.305(d) of this
chapter. Laidlomycin
as provided by No.
054771 in Sec.
510.600(c) of this
chapter.
(vi) 10 mg/lb of body weight Laidlomycin, 5 to Cattle fed in Feed continuously at 054771
daily. 10. confinement for a rate of 30 to 75
slaughter: For mg laidlomycin
treatment of propionate potassium
bacterial enteritis per head per day for
caused by E. coli and not more than 5
bacterial pneumonia days. A withdrawal
caused by P. period has not been
multocida organisms established for this
susceptible to product in pre-
chlortetracycline; ruminating calves.
and for improved feed Do not use in calves
efficiency. to be processed for
veal. See Sec.
558.305(d) of this
chapter. Laidlomycin
as provided by No.
054771 in Sec.
510.600(c) of this
chapter.
(vii) 500 to 2,000 to provide Lasalocid, 10 to Cattle fed in Feed continuously in 054771
10 mg/lb of body weight daily. 30. confinement for complete feed for
slaughter: For not more than 5 days
treatment of to provide 10 mg
bacterial enteritis chlortetracycline
caused by E. coli and per lb. body weight
bacterial pneumonia per day and not less
caused by P. than 100 mg or more
multocida organisms than 360 mg
susceptible to lasalocid per head
chlortetracycline; per day. Do not
and for improved feed allow horses or
efficiency. other equines access
to feeds containing
lasalocid. No
withdrawal period is
required. A
withdrawal period
has not been
established for this
product in pre-
ruminating calves.
Do not use in calves
to be processed for
veal. See Sec.
558.311(d) of this
chapter. Lasalocid
as provided by No.
054771 in Sec.
510.600(c) of this
chapter.
Page 95000
(viii) 500 to 1,200 to provide Lasalocid, 25 to Cattle fed in Feed continuously in 054771
10 mg/lb of body weight daily. 30. confinement for complete feed for
slaughter: For not more than 5 days
treatment of to provide 10 mg
bacterial enteritis chlortetracycline
caused by E. coli and per lb. body weight
bacterial pneumonia per day and not less
caused by P. than 250 mg or more
multocida organisms than 360 mg
susceptible to lasalocid per head
chlortetracycline; per day. Do not
and for increased allow horses or
rate of weight gain other equines access
and improved feed to feeds containing
efficiency. lasalocid. No
withdrawal period is
required. A
withdrawal period
has not been
established for this
product in pre-
ruminating calves.
Do not use in calves
to be processed for
veal. See Sec.
558.311(d) of this
chapter. Lasalocid
as provided by No.
054771 in Sec.
510.600(c) of this
chapter.
(ix) 500 to 4,000 to provide Lasalocid, 30 to Pasture cattle Feed continuously on 054771
10 mg/lb of body weight daily. 600. (slaughter, stocker, a hand-fed basis for
feeder cattle, dairy not more than 5 days
and beef replacement to provide 10 mg
heifers): For chlortetracycline
treatment of per lb. body weight
bacterial enteritis per day and not less
caused by E. coli and than 60 mg or more
bacterial pneumonia than 300 mg
caused by P. lasalocid per head
multocida organisms per day. Daily
susceptible to lasalocid intakes in
chlortetracycline; excess of 200 mg/
and for increased head/day in pasture
rate of weight gain cattle have not been
and improved feed shown to be more
efficiency. effective than 200
mg lasalocid/head/
day. Do not allow
horses or other
equines access to
feeds containing
lasalocid. No
withdrawal period is
required. A
withdrawal period
has not been
established for this
product in pre-
ruminating calves.
Do not use in calves
to be processed for
veal. See Sec.
558.311(d) of this
chapter. Lasalocid
as provided by No.
054771 in Sec.
510.600(c) of this
chapter.
(x) 500 to 4,000 g/ton........ ................. Calves, beef and Feed continuously for 054771
nonlactating dairy not more than 5 days 069254
cattle: For the to provide 10 mg/lb
treatment of body weight per day.
bacterial enteritis To sponsor No.
caused by E. coli and 054771 under NADA
bacterial pneumonia 046-699: 24-hour
caused by P. withdrawal period.
multocida susceptible To sponsor No.
to chlortetracycline. 054771 under NADA
048-761 and No.
069254 under ANADA
200-510: Zero
withdrawal period.
(xi) 500 to 4,000............. Decoquinate, 12.9 Calves, beef and non- Feed at a rate of 1g 054771
to 90.8. lactating dairy chlortetracycline 069254
cattle: For the per 100 lb body
treatment of weight/day and 22.7
bacterial enteritis mg decoquinate per
caused by E. coli and 100 lb of body
bacterial pneumonia weight/day for not
caused by P. more than 5 days.
multocida susceptible When it is fully
to chlortetracycline; consumed, resume
and for the feeding 22.7 mg
prevention of decoquinate per 100
coccidiosis caused by lb of body weight/
Eimeria bovis and E. day for a total of
zuernii. 28 days to prevent
coccidiosis.
Withdraw 24 hours
prior to slaughter.
A withdrawal period
has not been
established for this
product in pre-
ruminating calves.
Do not use in calves
to be processed for
veal. Do not feed to
animals producing
milk for food.
Decoquinate as
provided by No.
054771 in Sec.
510.600(c) of this
chapter.
(xii) 4,000 to 20,000 g/ton... ................. Calves, beef and As a top dress, 054771
nonlactating dairy varying with body
cattle: For the weight and feed
treatment of consumption, to
bacterial enteritis provide 10 mg/lb per
caused by E. coli and day. Treat for not
bacterial pneumonia more than 5 days.
caused by P. See paragraph (d)(3)
multocida organisms of this section.
susceptible to
chlortetracycline.
Page 95001
(xiii) 4,000 to 20,000 g/ton.. Decoquinate, 90.8 Calves, beef and non- Administer as a top 054771
to 535.7. lactating dairy dress supplement or
cattle: For the mix into the daily
treatment of ration to provide
bacterial enteritis 22.7 mg decoquinate
caused by E. coli and per 100 lb of body
bacterial pneumonia weight per day and 1
caused by P. g chlortetracycline
multocida susceptible per 100 lb body
to chlortetracycline; weight/day for not
and for the more than 5 days.
prevention of When it is fully
coccidiosis caused by consumed, resume
E. bovis and E. feeding 22.7 mg
zuernii. decoquinate per 100
lb of body weight/
day for a total of
28 days to prevent
coccidiosis.
Withdraw 24 hours
prior to slaughter.
A withdrawal period
has not been
established for this
product in pre-
ruminating calves.
Do not use in calves
to be processed for
veal. Do not feed to
animals producing
milk for food.
Decoquinate as
provided by No.
054771 in Sec.
510.600(c) of this
chapter.
(xiv) 70 mg/head/day.......... ................. Growing cattle (over See paragraph (d)(3) 054771
400 lb): For of this section. 066104
reduction of 069254
incidence of liver
abscesses.
(xv) 350 mg/head/day.......... ................. 1. Beef cattle: For Withdraw 48 h prior 054771 066104
control of bacterial to slaughter. To 069254
pneumonia associated sponsor No. 054771
with shipping fever under NADA 046-699:
complex caused by 48-hour withdrawal
Pasteurella spp. time. To sponsor No.
susceptible to 054771 under NADA
chlortetracycline. 048-761 and No.
069254 under ANADA
200-510: zero
withdrawal period.
2. Beef cattle (under Withdraw 48 h prior 054771 066104
700 lb): For control to slaughter. To 069254
of active infection sponsor No. 054771
of anaplasmosis under NADA 046-699:
caused by A. 48-hour withdrawal
marginale susceptible time. To sponsor No.
to chlortetracycline. 054771 under NADA
048-761 and No.
069254 under ANADA
200-510: zero
withdrawal time.
(xvi) 350 mg/head/day......... Laidlomycin, 5... Cattle fed in Feed continuously at 054771
confinement for a rate of 30 to 75
slaughter: For mg laidlomycin
control of bacterial propionate potassium
pneumonia associated per head per day. A
with shipping fever withdrawal period
complex caused by has not been
Pasteurella spp. established for this
susceptible to product in pre-
chlortetracycline; ruminating calves.
and for increased Do not use in calves
rate of weight and to be processed for
improved feed veal. See Sec.
efficiency. 558.305(d) of this
chapter. Laidlomycin
as provided by No.
054771 in Sec.
510.600(c) of this
chapter.
(xvii) 350 mg/head/day........ Laidlomycin, 5 to Cattle fed in Feed continuously at 054771
10. confinement for a rate of 30 to 75
slaughter: For mg laidlomycin
control of bacterial propionate potassium
pneumonia associated per head per day. A
with shipping fever withdrawal period
complex caused by has not been
Pasteurella spp. established for this
susceptible to product in pre-
chlortetracycline; ruminating calves.
and for improved feed Do not use in calves
efficiency. to be processed for
veal. See Sec.
558.305(d) of this
chapter. Laidlomycin
as provided by No.
054771 in Sec.
510.600(c) of this
chapter.
(xviii) 25 to 42.2 g/ton to Lasalocid, 25 to Cattle under 700 Feed continuously in 054771
provide 350 mg/head/day. 30. pounds fed in complete feed at a
confinement for rate of 350 mg
slaughter: For chlortetracycline
control of active and not less than
infection of 250 mg nor more than
anaplasmosis caused 360 mg lasalocid per
by A. marginale head daily. Do not
susceptible to allow horses or
chlortetracycline; other equines access
and for increased to feeds containing
rate of weight gain lasalocid. No
and improved feed withdrawal period is
efficiency. required. A
withdrawal period
has not been
established for this
product in pre-
ruminating calves.
Do not use in calves
to be processed for
veal. See Sec.
558.311(d) of this
chapter. Lasalocid
as provided by No.
054771 in Sec.
510.600(c) of this
chapter.
Page 95002
(xix) 25 to 42.2 g/ton to Lasalocid, 25 to Cattle fed in Feed continuously in 054771
provide 350 mg/head/day. 30. confinement for complete feed at a
slaughter: For rate of 350 mg
control of bacterial chlortetracycline
pneumonia associated and not less than
with shipping fever 250 mg nor more than
complex caused by P. 360 mg lasalocid per
multocida organisms head daily. Do not
susceptible to allow horses or
chlortetracycline; other equines access
and for increased to feeds containing
rate of weight gain lasalocid. No
and improved feed withdrawal period is
efficiency. required. A
withdrawal period
has not been
established for this
product in pre-
ruminating calves.
Do not use in calves
to be processed for
veal. See Sec.
558.311(d) of this
chapter. Lasalocid
as provided by No.
054771 in Sec.
510.600(c) of this
chapter.
(xx) 25 to 100 g/ton to Lasalocid, 10 to Cattle under 700 Feed continuously in 054771
provide 350 mg/head/day. 30. pounds fed in complete feed at a
confinement for rate of 350 mg
slaughter: For chlortetracycline
control of active and not less than
infection of 100 mg nor more than
anaplasmosis caused 360 mg lasalocid per
by A. marginale head daily. Do not
susceptible to allow horses or
chlortetracycline; other equines access
and for improved feed to feeds containing
efficiency. lasalocid. No
withdrawal period is
required. A
withdrawal period
has not been
established for this
product in pre-
ruminating calves.
Do not use in calves
to be processed for
veal. See Sec.
558.311(d) of this
chapter. Lasalocid
as provided by No.
054771 in Sec.
510.600(c) of this
chapter.
(xxi) 25 to 100 g/ton to Lasalocid, 10 to Cattle fed in Feed continuously in 054771
provide 350 mg/head/day. 30. confinement for complete feed at a
slaughter: For rate of 350 mg
control of bacterial chlortetracycline
pneumonia associated and not less than
with shipping fever 100 mg nor more than
complex caused by P. 360 mg lasalocid per
multocida organisms head daily. Do not
susceptible to allow horses or
chlortetracycline; other equines access
and for improved feed to feeds containing
efficiency. lasalocid. No
withdrawal period is
required. A
withdrawal period
has not been
established for this
product in pre-
ruminating calves.
Do not use in calves
to be processed for
veal. See Sec.
558.311(d) of this
chapter. Lasalocid
as provided by No.
054771 in Sec.
510.600(c) of this
chapter.
(xxii) 25 to 700 to provide Lasalocid, 30 to Pasture cattle Feed continuously on 054771
350 mg/head/day. 600. (slaughter, stocker, a hand-fed basis at
feeder cattle, dairy a rate of 350 mg
and beef replacement chlortetracycline
heifers): For control and not less than 60
of bacterial mg nor more than 300
pneumonia associated mg lasalocid per
with shipping fever head per day in at
complex caused by P. least 1 pound of
multocida organisms feed. Daily
susceptible to lasalocid intakes in
chlortetracycline; excess of 200 mg/
and for increased head/day in pasture
rate of weight gain. cattle have not been
shown to be more
effective than 200
mg lasalocid/head/
day. Do not allow
horses or other
equines access to
feeds containing
lasalocid. No
withdrawal period is
required. A
withdrawal period
has not been
established for this
product in pre-
ruminating calves.
Do not use in calves
to be processed for
veal. See Sec.
558.311(d) of this
chapter. Lasalocid
as provided by No.
054771 in Sec.
510.600(c) of this
chapter.
Page 95003
(xxiii) 25 to 700 to provide Lasalocid, 30 to Pasture cattle Feed continuously on 054771
350 mg/head/day. 600. (slaughter, stocker, a hand-fed basis at
feeder cattle, beef a rate of 350 mg
replacement heifers) chlortetracycline
under 700 pounds: For and not less than 60
control of active mg nor more than 300
infection of mg lasalocid per
anaplasmosis caused head per day in at
by A. marginale least 1 pound of
susceptible to feed. Daily
chlortetracycline; lasalocid intakes in
and for increased excess of 200 mg/
rate of weight gain. head/day in pasture
cattle have not been
shown to be more
effective than 200
mg lasalocid/head/
day. Do not allow
horses or other
equines access to
feeds containing
lasalocid. No
withdrawal period is
required. A
withdrawal period
has not been
established for this
product in pre-
ruminating calves.
Do not use in calves
to be processed for
veal. See Sec.
558.311(d) of this
chapter. Lasalocid
as provided by No.
054771 in Sec.
510.600(c) of this
chapter.
(xxiv) 25 to 2,800 to provide Lasalocid, 30 to Beef cattle weighing Hand feed 054771
350 mg/head/day. 181.8. up to 800 pounds: For continuously at a
control of bacterial rate of 350 mg
pneumonia associated chlortetracycline
with shipping fever and 1 mg lasalocid
complex caused by per 2.2 lb. body
Pasteurella spp. weight daily to
susceptible to cattle with a
chlortetracycline; maximum of 360 mg of
and for the control lasalocid per head
of coccidiosis caused per day. Do not
by E. bovis and E. allow horses or
zuernii. other equines access
to feeds containing
lasalocid. No
withdrawal period is
required. A
withdrawal period
has not been
established for this
product in pre-
ruminating calves.
Do not use in calves
to be processed for
veal. See Sec.
558.311(d) of this
chapter. Lasalocid
as provided by No.
054771 in Sec.
510.600(c) of this
chapter.
(xxv) 500 to 4,000 to provide Lasalocid, 30 to Cattle weighing up to Hand feed 054771
350 mg/head/day. 181.8. 800 pounds: For the continuously at a
treatment of rate of 350 mg
bacterial enteritis chlortetracycline
caused by E. coli and and 1 mg lasalocid
bacterial pneumonia per 2.2 lb. body
caused by P. weight daily to
multocida susceptible cattle with a
to chlortetracycline; maximum of 360 mg of
and for the control lasalocid per head
of coccidiosis caused per day. Do not
by E. bovis and E. allow horses or
zuernii. other equines access
to feeds containing
lasalocid. No
withdrawal period is
required. A
withdrawal period
has not been
established for this
product in pre-
ruminating calves.
Do not use in calves
to be processed for
veal. See Sec.
558.311(d) of this
chapter. Lasalocid
as provided by No.
054771 in Sec.
510.600(c) of this
chapter.
----------------------------------------------------------------------------------------------------------------
(5) Minor species. It is used as follows:
----------------------------------------------------------------------------------------------------------------
Chlortetracycline amount Indications for use Limitations Sponsor
----------------------------------------------------------------------------------------------------------------
(i) 80 mg/head/day................ Breeding sheep; reducing the ............................. 054771
incidence of (vibrionic) 066104
abortion caused by 069254
Campylobacter fetus
infection susceptible to
chlortetracycline.
(ii) 200 to 400 g/ton............. Ducks: For the control and Feed in complete ration to 054771
treatment of fowl cholera provide from 8 to 28 mg/lb
caused by Pasteurella of body weight per day,
multocida susceptible to depending upon age and
chlortetracycline. severity of disease, for not
more than 21 days. Do not
feed to ducks producing eggs
for human consumption.
(iii) 10 mg/g of finished feed Psittacine birds (cockatoos, Feed continuously for 45 054771
daily. macaws, and parrots) days. Each bird should
suspected or known to be consume daily an amount of
infected with psittacosis medicated feed equal to one
caused by Chlamydia psittaci fifth of its body weight.
sensitive to See paragraph (d)(5) of this
chlortetracycline. section.
----------------------------------------------------------------------------------------------------------------
Page 95004
(6) It is used as a free-choice, loose mineral Type C feed as follows:
(i) Specifications.
------------------------------------------------------------------------
International
Ingredient Percent feed No.
------------------------------------------------------------------------
Dicalcium Phosphate............... 46.20 6-26-335
Sodium Chloride (Salt)............ 15.00 6-04-152
Magnesium Oxide................... 10.67 6-02-756
Cottonseed Meal................... 10.00 5-01-625
Trace Mineral/Vitamin Premix \1\.. 3.80 .................
Calcium Carbonate................. 3.50 6-01-069
Dried Cane Molasses............... 3.00 4-04-695
Potassium Chloride................ 2.00 6-03-755
Mineral Oil....................... 2.00 8-03-123
Iron Oxide........................ 0.50 6-02-431
Chlortetracycline Type A medicated 3.33 .................
article (90 gram/lb).............
------------------------------------------------------------------------
\1\ Content of vitamin and trace mineral premixes may be varied.
However, they should be comparable to those used for other free-choice
feeds. Formulation modifications require FDA approval prior to
marketing. Selenium must comply with 21 CFR 573.920. Ethylenediamine
dihydroiodide (EDDI) should comply with FDA Compliance Policy Guides
Sec. 651.100 (CPG 7125.18).
(ii) Amount. 6,000 grams per ton.
(iii) Indications for use. Beef and nonlactating dairy cattle: As an aid in the control of active infection of anaplasmosis caused by Anaplasma marginale susceptible to chlortetracycline.
(iv) Limitations. Feed continuously on a free-choice basis at a rate of 0.5 to 2.0 mg chlortetracycline per pound of body weight per day.
(v) Sponsor. See No. 054771 in Sec. 510.600(c) of this chapter.
0
9. In Sec. 558.140, redesignate paragraph (d) as paragraph (e) and add new paragraph (d) to read as follows:
Sec. 558.140 Chlortetracycline and sulfamethazine.
* * * * *
(d) Special considerations--(1) Federal law restricts medicated feed containing this veterinary feed directive (VFD) drug to use by or on the order of a licensed veterinarian. See Sec. 558.6 for additional requirements.
(2) The expiration date of VFDs for chlortetracycline and sulfamethazine medicated feeds must not exceed 6 months from the date of issuance. VFDs for chlortetracycline and sulfamethazine shall not be refilled.
* * * * *
Sec. 558.145 Removed
0
10. Remove Sec. 558.145.
0
11. In Sec. 558.175, in paragraph (b), remove ``Approvals'' and in its place add ``Sponsor''; add paragraph (c); remove and reserve paragraphs (d)(5) and (6); and add paragraph (e) to read as follows:
Sec. 558.175 Clopidol.
* * * * *
(c) Related tolerances. See Sec. 556.160 of this chapter.
* * * * *
(e) Clopidol may also be used in combination with:
(1) Reserved
(2) Reserved
(3) Chlortetracycline as in Sec. 558.128.
(4) Lincomycin as in Sec. 558.325.
0
12. In Sec. 558.195, remove and reserve paragraphs (e)(1)(iv) through (vi), (e)(2)(ii), (e)(2)(iv), and (e)(2)(vii); and add paragraph (e)(4) to read as follows:
Sec. 558.195 Decoquinate.
* * * * *
(e) * * *
(4) Decoquinate may also be used in combination with:
(i) Reserved
(ii) Reserved
(iii) Chlortetracycline as in Sec. 558.128.
(iv) Lincomycin as in Sec. 558.325.
0
13. In Sec. 558.198, remove and reserve paragraphs (d)(1)(iv) and (v); and add paragraph (d)(3) to read as follows:
Sec. 558.198 Diclazuril.
* * * * *
(d) * * *
(3) Diclazuril may also be used in combination with virginiamycin as in Sec. 558.635.
0
14. In Sec. 558.248, revise paragraph (a); redesignate paragraph (d) as paragraph (e); add new paragraph (d); and revise redesignated paragraph (e) to read as follows:
Sec. 558.248 Erythromycin.
(a) Specifications. Type A medicated articles containing 92.5 grams per pound erythromycin (as the thiocyanate salt).
* * * * *
(d) Special considerations.--(1) Federal law restricts medicated feed containing this veterinary feed directive (VFD) drug to use by or on the order of a licensed veterinarian. See Sec. 558.6 for additional requirements.
(2) The expiration date of VFDs for erythromycin medicated feeds must not exceed 6 months from the date of issuance. VFDs for erythromycin shall not be refilled.
(e) Conditions of use--(1) Chickens--
----------------------------------------------------------------------------------------------------------------
Combination in
Erythromycin in grams/ton grams/ton Indications for use Limitations Sponsor
----------------------------------------------------------------------------------------------------------------
(i) 92.5................... .................. Chickens: As an aid in Feed for 2 days before 061623
the prevention of stress and 3 to 6
chronic respiratory days after stress.
disease during periods Withdraw 24 hours
of stress. before slaughter.
(ii) 92.5.................. .................. Chickens: As an aid in Feed for 7 to 14 days. 061623
the prevention of Withdraw 24 hours
infectious coryza. before slaughter.
(iii) 185.................. .................. Chickens: As an aid in Feed for 5 to 8 days. 061623
the prevention and Withdraw 48 hours
reduction of lesions before slaughter. Do
and in lowering not use in birds
severity of chronic producing eggs for
respiratory disease food.
(CRD).
----------------------------------------------------------------------------------------------------------------
Page 95005
(2) Turkeys--
----------------------------------------------------------------------------------------------------------------
Erythromycin thiocyanate in Combination in
grams/ton grams/ton Indications for use Limitations Sponsor
----------------------------------------------------------------------------------------------------------------
(i) 92.5................... .................. Turkeys: As an aid in Feed for 2 days before 061623
the prevention of stress and 3 to 6
chronic respiratory days after stress.
disease during periods
of stress.
(ii) 185................... .................. Turkeys: As an aid in Feed for 5 to 8 days. 061623
the prevention and Do not use in birds
reduction of lesions producing eggs for
and in lowering food.
severity of chronic
respiratory disease
(CRD).
----------------------------------------------------------------------------------------------------------------
0
15. In Sec. 558.258, remove and reserve paragraphs (e)(2)(ii) through (v); and add paragraph (e)(6) to read as follows:
Sec. 558.258 Fenbendazole.
* * * * *
(e) * * *
(6) Fenbendazole may also be used in combination with:
(i) Reserved
(ii) Lincomycin as in Sec. 558.325.
0
16. In Sec. 558.265, remove and reserve paragraphs (d)(1)(iii), (d)(1)(iv), and (d)(1)(vii); and add paragraph (d)(4) to read as follows:
Sec. 558.265 Halofuginone.
* * * * *
(d) * * *
(4) Halofuginone may also be used in combination with:
(i) Reserved
(ii) Lincomycin as in Sec. 558.325.
(iii) Virginiamycin as in Sec. 558.635.
0
17. Revise Sec. 558.274 to read as follows:
Sec. 558.274 Hygromycin B.
(a) Specifications. Type A medicated articles containing 2.4 or 8 grams hygromycin B per pound (g/lb).
(b) Sponsor. See No. 058198 in Sec. 510.600(c) of this chapter for as follows:
(c) Related tolerances. See Sec. 556.330 of this chapter.
(d) Special considerations--(1) Federal law restricts medicated feed containing this veterinary feed directive (VFD) drug to use by or on the order of a licensed veterinarian. See Sec. 558.6 for additional requirements.
(2) The expiration date of VFDs for hygromycin B medicated feeds must not exceed 6 months from the date of issuance. VFDs for hygromycin B shall not be refilled.
(e) Conditions of use. It is used in feed as follows:
(1) Chickens--
----------------------------------------------------------------------------------------------------------------
Combination in
Hygromycin B grams/ton grams/ton Indications for use Limitations Sponsor
----------------------------------------------------------------------------------------------------------------
(i) 8 to 12................ .................. Chickens: For control Use in complete feed. 058198
of infections of large Withdraw 3 days
roundworms (Ascaris before slaughter.
galli), cecal worms
(Heterakis gallinae),
and capillary worms
(Capillaria obsignata).
(ii) Reserved
----------------------------------------------------------------------------------------------------------------
(2) Swine--
----------------------------------------------------------------------------------------------------------------
Combination in
Hygromycin B grams/ton grams/ton Indications for use Limitations Sponsor
----------------------------------------------------------------------------------------------------------------
(i) 12..................... .................. Swine: For control of In market hogs, use in 058198
infections of large complete feed for 8
roundworms (A. suis), weeks during the
nodular worms (O. growing period.
dentatum), and Withdraw 15 days
whipworms (Trichuris before slaughter.
suis).
(ii) Reserved
----------------------------------------------------------------------------------------------------------------
0
18. In Sec. 558.300, remove and reserve paragraphs (e)(4) through (7); and add paragraph (f) to read as follows:
Sec. 558.300 Ivermectin.
* * * * *
(f) Ivermectin may also be used in combination with:
(1) Reserved
(2) Lincomycin as in Sec. 558.325.
0
19. In Sec. 558.305, remove paragraphs (e)(2), (e)(3), (e)(5), and (e)(6); redesignate paragraph (e)(4) as new paragraph (e)(2); and add paragraph (f) to read as follows:
Sec. 558.305 Laidlomycin.
* * * * *
(f) Laidlomycin may also be used in combination with chlortetracycline as in Sec. 558.128.
0
20. In Sec. 558.311, in paragraph (e)(1)(i), in the row entry for ``Bambermycins 1 to 2'', in the ``Lasalocid sodium in grams per ton'' column, add ``(ii) 68 (0.0075 pct) to 113 (0.0125 pct).''; in paragraphs (e)(1)(vi) and (vii), remove the row entries for ``Oxytetracycline 7.5''; in paragraph (e)(1)(xv), remove the row entry for ``Virginiamycin 10 to 20''; remove and reserve paragraphs (e)(1)(iii), (e)(1)(v), and (e)(1)(xx) through (e)(1)(xxviii); redesignate paragraph (e)(5)(i) as paragraph (e)(5)(ii); and add new paragraphs (e)(5)(i) and (e)(5)(iii) to read as follows:
Sec. 558.311 Lasalocid.
* * * * *
(e) * * *
(5) * * *
(i) Chlortetracycline as in Sec. 558.128.
* * * * *
(iii) Virginiamycin as in Sec. 558.635.
0
21. Revise Sec. 558.325 to read as follows:
Page 95006
Sec. 558.325 Lincomycin.
(a) Specifications. Type A medicated articles containing 20 or 50 grams of lincomycin (as lincomycin hydrochloride) per pound.
(b) Sponsors. See No. 054771 in Sec. 510.600(c) of this chapter.
(c) Related tolerances. See Sec. 556.360 of this chapter.
(d) Special considerations--(1) Federal law restricts medicated feed containing this veterinary feed directive (VFD) drug to use by or on the order of a licensed veterinarian. See Sec. 558.6 for additional requirements.
(2) The expiration date of VFDs for chlortetracycline and sulfamethazine medicated feeds must not exceed 6 months from the date of issuance. VFDs for chlortetracycline and sulfamethazine shall not be refilled.
(3) Labeling of Type A medicated articles and Type B and Type C medicated feeds containing lincomycin shall bear the following:
(i) ``CAUTION: Do not allow rabbits, hamsters, guinea pigs, horses, or ruminants access to feeds containing lincomycin. Ingestion by these species may result in severe gastrointestinal effects.''
(4) Labeling of medicated feeds containing lincomycin intended for use in swine shall bear the following:
(i) ``CAUTION: Occasionally, swine fed lincomycin may within the first 2 days after the onset of treatment develop diarrhea and/or swelling of the anus. On rare occasions, some pigs may show reddening of the skin and irritable behavior. These conditions have been self-
correcting within 5 to 8 days without discontinuing the lincomycin treatment.''
(ii) ``CAUTION: The effects of lincomycin on swine reproductive performance, pregnancy, and lactation have not been determined.''
(e) Conditions of use--(1) Chickens--
----------------------------------------------------------------------------------------------------------------
Combination in
Lincomycin grams/ton grams/ton Indications for use Limitations Sponsors
----------------------------------------------------------------------------------------------------------------
(i) 2...................... .................. Broilers: For the Feed as the sole 054771
control of necrotic ration. Not for use
enteritis caused or in layers, breeders,
complicated by or turkeys.
Clostridium spp. or
other organisms
susceptible to
lincomycin.
(ii) Reserved
----------------------------------------------------------------------------------------------------------------
(2) Swine--
----------------------------------------------------------------------------------------------------------------
Combination in
Lincomycin grams/ton grams/ton Indications for use Limitations Sponsors
----------------------------------------------------------------------------------------------------------------
(i) 40..................... .................. For control of swine Feed as sole ration. 054771
dysentery and the For use in swine on
control of porcine premises with a
proliferative history of swine
enteropathies dysentery but where
(ileitis) caused by symptoms have not yet
Lawsonia occurred, or
intracellularis. following use of
lincomycin at 100
grams (g)/ton for the
treatment of swine
dysentery and the
control of porcine
proliferative
enteropathies
(ileitis).
(ii) 40.................... Fenbendazole, 10 For control of swine Feed as sole ration to 000061
to 80. dysentery in animals provide a total dose
on premises with a of 9 mg fenbendazole/
history of swine kg of body weight
dysentery, but where within 3 to 12 days.
symptoms have not yet Do not feed to swine
occurred; and for the that weigh more than
removal of: Adult 250 pounds.
stage lungworms Lincomycin as
(Metastrongylus apri provided by No.
and M. pudendotectus); 054771; fenbendazole
adult and larvae (L3, as provided by No.
4 stages--liver, lung, 000061 in Sec.
intestinal forms) 510.600(c) of this
large roundworms chapter.
(Ascaris suum); adult
stage nodular worms
(Oesophagostomum
dentatum, O.
quadrispinulatum);
adult stage small
stomach worms
(Hyostrongylus
rubidus); adult and
larvae (L2, 3, 4
stages--intestinal
mucosal forms)
whipworms (Trichuris
suis); adult and
larvae kidney worms
(Stephanurus dentatus).
Page 95007
(iii) 40................... Ivermectin, 1.8... Weaned, growing and Feed as the only feed 050604
finishing swine: For for 7 consecutive
control of swine days to provide 0.1
dysentery on premises mg ivermectin/kg of
with a history of body weight per day.
swine dysentery, but A separate feed
where symptoms have containing 40 g/ton
not yet occurred; and lincomycin may be
for treatment and continued to complete
control of the lincomycin
gastrointestinal treatment. Not to be
roundworms (Ascaris fed to swine that
suum, adults and weigh more than 250
fourth-stage larvae; lbs. Withdraw 5 days
Ascarops strongylina, before slaughter.
adults; Hyostrongylus Lincomycin as
rubidus, adults and provided by No.
fourth-stage larvae; 054771; ivermectin as
Oesophagostomum spp., provided by No.
adults and fourth- 050604 in Sec.
stage larvae); kidney 510.600(c) of this
worms (Stephanurus chapter.
dentatus, adults and
fourth-stage larvae);
lungworms
(Metastrongylus spp.,
adults); lice
(Haematopinus suis);
and mange mites
(Sarcoptes scabiei
var. suis).
(iv) 40.................... Pyrantel, 96...... For control of swine Feed as the sole 066104
dysentery on premises ration. Not to be fed
with a history of to swine that weigh
swine dysentery, but more than 250 pounds.
where symptoms have Withdraw 6 days prior
not yet occurred; as to slaughter.
an aid in the Lincomycin as
prevention of provided by No.
migration and 054771; pyrantel as
establishment of large provided by No.
roundworm (Ascaris 066104 in Sec.
suum) infections; and 510.600(c) of this
as an aid in the chapter.
prevention of
establishment of
nodular worm
(Oesophagostomum spp.)
infections.
(v) 40..................... Pyrantel, 96...... For the treatment and/ Feed for 3 days as the 066104
or control of swine sole ration. Not to
dysentery; for removal be fed to swine that
and control of large weigh more than 250
roundworm (Ascaris pounds. Withdraw 24
suum) infections. hours prior to
slaughter. Lincomycin
as provided by No.
054771; pyrantel as
provided by No.
066104 in Sec.
510.600(c) of this
chapter.
(vi) 40 or 100............. Pyrantel, 96...... For the treatment and/ For treatment of swine 066104
or control of swine dysentery, feed 100
dysentery; as an aid grams of lincomycin
in the prevention of and 96 grams of
migration and pyrantel tartrate per
establishment of large ton of complete feed
roundworm (Ascaris for 3 weeks or until
suum) infections; and clinical signs of the
as an aid in the disease disappear,
prevention of following with 40
establishment of grams of lincomycin
nodular worm and 96 grams of
(Oesophagostomum spp.) pyrantel tartrate per
infections. ton of complete feed
as the sole ration.
Not to be fed to
swine that weigh more
than 250 pounds.
Withdraw 6 days prior
to slaughter.
Lincomycin as
provided by No.
054771; pyrantel as
provided by No.
066104 in Sec.
510.600(c) of this
chapter.
(vii) 100.................. .................. For treatment of swine Feed as the sole 054771
dysentery and the ration for 3 weeks or
control of porcine until clinical signs
proliferative of the disease
enteropathies disappear.
(ileitis) caused by
Lawsonia
intracellularis.
(viii) 100................. Fenbendazole, 10 For the treatment of Feed as sole ration to 000061
to 80. swine dysentery; and provide a total dose
for the removal of: of 9 mg fenbendazole/
Adult stage lungworms kg of body weight
(Metastrongylus apri within 3 to 12 days.
and M. pudendotectus); Do not feed to swine
adult and larvae (L3, that weigh more than
4 stages--liver, lung, 250 pounds. Do not
intestinal forms) use within 6 days of
large roundworms slaughter. Lincomycin
(Ascaris suum); adult as provided by No.
stage nodular worms 054771; fenbendazole
(Oesophagostomum as provided by No.
dentatum, O. 000061 in Sec.
quadrispinulatum); 510.600(c) of this
adult stage small chapter.
stomach worms
(Hyostrongylus
rubidus); adult and
larvae (L2, 3, 4
stages--intestinal
mucosal forms)
whipworms (Trichuris
suis); adult and
larvae kidney worms
(Stephanurus dentatus).
Page 95008
(ix) 100................... Ivermectin, 1.8... Weaned, growing and Feed as the only feed 050604
finishing swine: For for 7 consecutive
the treatment of swine days to provide 0.1
dysentery; and for mg ivermectin/kg of
treatment and control body weight per day.
of gastrointestinal A separate feed
roundworms (Ascaris containing 100 g/ton
suum, adults and lincomycin may be
fourth-stage larvae; continued to complete
Ascarops strongylina, the lincomycin
adults; Hyostrongylus treatment. Not to be
rubidus, adults and fed to swine that
fourth-stage larvae; weigh more than 250
Oesophagostomum spp., lbs. Withdraw 6 days
adults and fourth- before slaughter.
stage larvae); Lincomycin as
kidneyworms provided by No.
(Stephanurus dentatus, 054771; ivermectin as
adults and fourth- provided by No.
stage larvae); 050604 in Sec.
lungworms 510.600(c) of this
(Metastrongylus spp., chapter.
adults); lice
(Haematopinus suis);
and mange mites
(Sarcoptes scabiei
var. suis).
(x) 100.................... Pyrantel, 96...... For the treatment of Feed as the sole 066104
swine dysentery; as an ration for 3 weeks or
aid in the prevention until clinical signs
of migration and of the disease
establishment of large disappear. Not to be
roundworm (Ascaris fed to swine that
suum) infections; and weigh more than 250
as an aid in the pounds. Withdraw 6
prevention of days prior to
establishment of slaughter. Lincomycin
nodular worm as provided by No.
(Oesophagostomum spp.) 054771; pyrantel as
infections. provided by No.
066104 in Sec.
510.600(c) of this
chapter.
(xi) 100................... Pyrantel, 96...... For the treatment and/ Feed for 3 days as the 066104
or control of swine sole ration. Not to
dysentery; for removal be fed to swine that
and control of large weigh more than 250
roundworm (Ascaris pounds. Withdraw 24
suum) infections. hours prior to
slaughter. Lincomycin
as provided by No.
054771; pyrantel as
provided by No.
066104 in Sec.
510.600(c) of this
chapter.
(xii) 100.................. Pyrantel, 800..... For the treatment and/ Feed as a single 066104
or control of swine therapeutic
dysentery; for removal treatment. Not to be
and control of large fed to swine that
roundworm (Ascaris weigh more than 250
suum) and nodular worm pounds. Withdraw 24
(Oesophagostomum spp.) hours prior to
infections. slaughter. Lincomycin
as provided by No.
054771; pyrantel as
provided by No.
066104 in Sec.
510.600(c) of this
chapter.
(xiii) 200................. .................. For reduction in the Feed as sole ration 054771
severity of swine for 21 days.
mycoplasmal pneumonia
caused by Mycoplasma
hyopneumoniae.
(xiv) 200.................. Fenbendazole, 10 For reduction in the Feed as sole ration to 000061
to 80. severity of swine provide a total dose
mycoplasmal pneumonia of 9 mg fenbendazole/
caused by Mycoplasma kg of body weight
hyopneumoniae; and for within 3 to 12 days.
the removal of: Adult Do not feed to swine
stage lungworms that weigh more than
(Metastrongylus apri 250 pounds. Do not
and M. pudendotectus); use within 6 days of
adult and larvae (L3, slaughter. Lincomycin
4 stages--liver, lung, as provided by No.
intestinal forms) 054771; fenbendazole
large roundworms as provided by No.
(Ascaris suum); adult 000061 in Sec.
stage nodular worms 510.600(c) of this
(Oesophagostomum chapter.
dentatum, O.
quadrispinulatum);
adult stage small
stomach worms
(Hyostrongylus
rubidus); adult and
larvae (L2, 3, 4
stages--intestinal
mucosal forms)
whipworms (Trichuris
suis); adult and
larvae kidney worms
(Stephanurus dentatus).
Page 95009
(xv) 200................... Ivermectin, 1.8... For reduction in the Feed as the only feed 050604
severity of swine for 7 consecutive
mycoplasmal pneumonia days to provide 0.1
caused by Mycoplasma mg ivermectin/kg of
hyopneumoniae; and for body weight per day.
treatment and control A separate feed
of gastrointestinal containing 200 g/ton
roundworms (Ascaris lincomycin may be
suum, adults and continued for an
fourth-stage larvae; additional 14 days to
Ascarops strongylina, complete the
adults; Hyostrongylus lincomycin treatment.
rubidus, adults and Not to be fed to
fourth-stage larvae; swine that weigh more
Oesophagostomum spp., than 250 lbs.
adults and fourth- Withdraw 6 days
stage larvae); before slaughter.
kidneyworms Lincomycin as
(Stephanurus dentatus, provided by No.
adults and fourth- 054771; ivermectin as
stage larvae); provided by No.
lungworms 050604 in Sec.
(Metastrongylus spp., 510.600(c) of this
adults); lice chapter.
(Haematopinus suis);
and mange mites
(Sarcoptes scabiei
var. suis).
(xvi) 200.................. Pyrantel, 96...... For reduction in the Feed as the sole 054771
severity of swine ration for 21 days.
mycoplasmal pneumonia Not for use in swine
caused by Mycoplasma that weigh more than
hyopneumoniae; and as 250 pounds. Withdraw
an aid in the 6 days before
prevention of slaughter. Lincomycin
migration and as provided by No.
establishment of large 054771; pyrantel as
roundworm (Ascaris provided by No.
suum) infections; aid 066104 in Sec.
in the prevention of 510.600(c) of this
establishment of chapter.
nodular worm
(Oesophagostomum spp.)
infections.
----------------------------------------------------------------------------------------------------------------
0
22. In Sec. 558.342, remove and reserve paragraphs (e)(1)(iii), (e)(1)(iv), (e)(1)(viii), (e)(1)(ix), and (e)(1)(xi); and revise paragraph (e)(2) to read as follows:
Sec. 558.342 Melengestrol.
* * * * *
(e) * * *
(2) Melengestrol may also be used in combination with:
(i) Ractopamine as in Sec. 558.500.
(ii) Tylosin as in Sec. 558.625.
(iii) Zilpaterol as in Sec. 558.665.
0
23. In Sec. 558.355, revise paragraphs (a) and (b); remove and reserve paragraphs (f)(1)(viii), (f)(1)(ix), (f)(1)(xiii), (f)(1)(xiv), (f)(1)(xxi), (f)(1)(xxii), (f)(1)(xxxi), (f)(2)(iv), (f)(3)(ii), and (f)(3)(xii); and revise paragraph (f)(8) to read as follows:
Sec. 558.355 Monensin.
(a) Specifications. Type A medicated articles containing 45, 60, 90.7, or 110 grams monensin, USP, per pound.
(b) Approvals. See sponsor numbers in Sec. 510.600(c) of this chapter for conditions of use as in paragraph (f) of this section:
(1) No. 058198 for use as in paragraph (f) of this section.
(2) No. 054771 for use as in paragraphs (f)(1)(xxiv) and (xxv) of this section.
(3) No. 058198 for use as in paragraphs (f)(1)(i), (iii), (iv), and (v) of this section.
* * * * *
(f) * * *
(8) Monensin may also be used in combination with:
(i) Chlortetracycline as in Sec. 558.128.
(ii) Decoquinate as in Sec. 558.195.
(iii) Lincomycin as in Sec. 558.325.
(iv) Melengestrol acetate as in Sec. 558.342.
(v) Oxytetracycline as in Sec. 558.128.
(vi) Ractopamine alone or in combination as in Sec. 558.500.
(vii) Tilmicosin as in Sec. 558.618.
(viii) Tylosin as in Sec. 558.625.
(ix) Virginiamycin as in Sec. 558.635.
(x) Zilpaterol alone or in combination as in Sec. 558.665.
0
24. In Sec. 558.364, redesignate paragraph (d) as paragraph (e) and revise paragraphs (a) through (d) to read as follows:
Sec. 558.364 Neomycin sulfate.
(a) Specifications. Type A medicated article containing 325 grams neomycin sulfate per pound.
(b) Sponsor. See No. 054771 in Sec. 510.600(c) of this chapter.
(c) Related tolerances. See Sec. 556.430 of this chapter.
(d) Special considerations--(1) Federal law restricts medicated feed containing this veterinary feed directive (VFD) drug to use by or on the order of a licensed veterinarian. See Sec. 558.6 for additional requirements.
(2) The expiration date of VFDs for neomycin medicated feeds must not exceed 6 months from the date of issuance. VFDs for neomycin shall not be refilled.
* * * * *
0
25. In Sec. 558.366, in the table in paragraph (d), remove the row entries under ``Nicarbazin in grams per ton'' ``27 to 45'' for ``Narasin 27 to 45 and Lincomycin 2 to 4''; and under ``Nicarbazin in grams per ton'' ``113.5 (0.0125 pct)'' for ``Lincomycin 2 (0.00044 pct)''; and add paragraph (e) to read as follows:
Sec. 558.366 Nicarbazin.
* * * * *
(e) * * *
(6) Nicarbazin may also be used in combination with:
(i) Reserved
(ii) Lincomycin as in Sec. 558.325.
Sec. 558.435 Removed
0
26. Remove Sec. 556.435.
0
27. Revise Sec. 558.450 to read as follows:
Sec. 558.450 Oxytetracycline.
(a) Specifications. Each pound of Type A medicated article contains:
(1) Oxytetracycline (from oxytetracycline quaternary salt) equivalent to 50 or 100 grams oxytetracycline hydrochloride; or oxytetracycline (from oxytetracycline dihydrate base) equivalent to 10, 30, 50, 100, or 200 grams oxytetracycline hydrochloride.
(2) Oxytetracycline (from oxytetracycline dihydrate base) equivalent to 50, 100, or 200 grams oxytetracycline hydrochloride; or 100 grams oxytetracycline hydrochloride.
(b) Sponsors. See sponsors in Sec. 510.600(c) of this chapter as follows:
Page 95010
(1) No. 066104: Type A medicated articles as in paragraph (a)(1) of this section.
(2) No. 069254: Type A medicated articles as in paragraph (a)(2) of this section.
(c) Related tolerances. See Sec. 556.500 of this chapter.
(d) Special considerations--(1) Federal law restricts medicated feed containing this veterinary feed directive (VFD) drug to use by or on the order of a licensed veterinarian. See Sec. 558.6 for additional requirements.
(2) The expiration date of VFDs for oxytetracycline medicated feeds must not exceed 6 months from the date of issuance. VFDs for oxytetracycline shall not be refilled.
(3) In accordance with Sec. 558.5, labeling shall bear the statement: ``For use in dry animal feed only. Not for use in liquid feed supplements.''
(e) Conditions of use--(1) Chickens--
----------------------------------------------------------------------------------------------------------------
Combination in
Oxytetracycline amount grams/ton Indications for use Limitations Sponsor
----------------------------------------------------------------------------------------------------------------
(i) 100 to 200 g/ton....... .................. Chickens: For control Feed continuously for 066104
of infectious 7 to 14 days. Do not 069254
synovitis caused by feed to chickens
Mycoplasma synoviae producing eggs for
and control of fowl human consumption. Do
cholera caused by not use in feed
Pasteurella multocida containing less than
susceptible to 0.55% dietary
oxytetracycline. calcium. Use in such
low calcium feeds may
result in violative
residues. Zero-day
withdrawal period.
(ii) 200 g/ton............. Monensin, 90 to Broiler chickens: As an Feed continuously as 066104
110. aid in the prevention the sole ration. Do
of coccidiosis caused not feed to laying
by Eimeria necatrix, chickens. Do not feed
E. tenella, E. to chickens over 16
acervulina, E. weeks of age. Do not
brunetti, E. mivati, use in feed
and E. maxima; and for containing less than
the control of 0.55% dietary
complicated chronic calcium. Use in such
respiratory disease low calcium feeds may
(CRD or air sac result in violative
infection) caused by residues. Withdraw 72
Mycoplasma hours before
gallisepticum and slaughter. See Sec.
Escherichia coli. 558.355(d) of this
chapter
Oxytetracycline as
provided by No.
066104; monensin as
provided by No.
058198 in Sec.
510.600(c) of this
chapter.
(iii) 400 g/ton............ .................. Chickens: For control Feed continuously for 066104
of chronic respiratory 7 to 14 days. Do not 069254
disease (CRD) and air feed to chickens
sac infection caused producing eggs for
by Mycoplasma human consumption. Do
gallisepticum and not use in feed
Escherichia coli containing less than
susceptible to 0.55% dietary
oxytetracycline. calcium. Use in such
low calcium feeds may
result in violative
residues. Zero-day
withdrawal period.
(iv) 400 g/ton............. Robenidine, 30.... Broiler chickens: As an Feed continuously for 066104
aid in the prevention 7 to 14 days. Do not
of coccidiosis caused feed to chickens
by Eimeria necatrix, producing eggs for
E. tenella, E. human consumption. Do
acervulina, E. not use in feed
brunetti, E. mivati, containing less than
and E. maxima; and for 0.55% dietary
the control of chronic calcium. Use in such
respiratory disease low calcium feeds may
(CRD) and air sac result in violative
infection caused by residues. Withdraw 5
Mycoplasma days before
gallisepticum and slaughter.
Escherichia coli Oxytetracycline as
susceptible to provided by No.
oxytetracycline. 066104; robenidine as
provided by No.
054771 in Sec.
510.600(c) of this
chapter.
(v) 500 g/ton.............. .................. Chickens: For reduction Feed continuously for 066104
of mortality due to 5 days. Do not feed 069254
air sacculitis (air to chickens producing
sac infection) caused eggs for human
by E. coli susceptible consumption. Do not
to oxytetracycline. use in feed
containing less than
0.55% dietary
calcium. Use in such
low calcium feeds may
result in violative
residues. Withdraw 24
hours before
slaughter.
(vi) 500 g/ton............. Monensin, 90 to Broiler chickens: As an Feed for 5 days as the 066104
100. aid in the prevention sole ration. Treat at
of coccidiosis caused first clinical signs
by Eimeria necatrix, of the disease. Do
E. tenella, E. not feed to laying
acervulina, E. chickens. Do not feed
brunetti, E. mivati, to chickens over 16
and E. maxima; and as weeks of age. Do not
an aid in the use in feed
reduction of mortality containing less than
due to air-sacculitis 0.55% dietary
(air sac infection) calcium. Use in such
caused by Escherichia low calcium feeds may
coli sensitive to result in violative
oxytetracycline. residues. Withdraw 72
hours before
slaughter. See Sec.
558.355(d) of this
chapter.
Oxytetracycline as
provided by No.
066104; monensin as
provided by No.
058198 in Sec.
510.600(c) of this
chapter.
Page 95011
(vii) 500 g/ton............ Salinomycin, 40 to Chickens: For the Feed for 5 days as the 066104
60. prevention of sole ration. Treat at 016592
coccidiosis caused by first clinical signs
Eimeria necatrix, E. of the disease. Do
tenella, E. not feed to laying
acervulina, E. chickens. Do not use
brunetti, E. mivati, in feed containing
and E. maxima; and as less than 0.55%
an aid in the dietary calcium. Use
reduction of mortality in such low calcium
due to air-sacculitis feeds may result in
(air sac infection) violative residues.
caused by E. coli Withdraw 24 hours
sensitive to before slaughter.
oxytetracycline. Oxytetracycline as
provided by No.
066104; salinomycin
as provided by No.
016592 in Sec.
510.600(c) of this
chapter.
----------------------------------------------------------------------------------------------------------------
(2) Turkeys--
----------------------------------------------------------------------------------------------------------------
Oxytetracycline amount Indications for use Limitations Sponsor
----------------------------------------------------------------------------------------------------------------
(i) 100 g/ton..................... Turkeys: For control of Feed continuously for 7 to 14 066104
hexamitiasis caused by days. Do not feed to turkeys 069254
Hexamita meleagridis producing eggs for human
susceptible to consumption. Zero-day
oxytetracycline. withdrawal period.
(ii) 200 g/ton.................... Turkeys: For control of Feed continuously for 7 to 14 066104
infectious synovitis caused days. Do not feed to turkeys 069254
by M. synoviae susceptible producing eggs for human
to oxytetracycline. consumption. For No. 066104,
withdraw 5 days before
slaughter. For No. 069254,
zero-day withdrawal period.
(iii) 25 mg/lb of body weight Turkeys: For control of Feed continuously for 7 to 14 066104
daily. complicating bacterial days. Do not feed to turkeys 069254
organisms associated with producing eggs for human
bluecomb (transmissible consumption. For No. 066104,
enteritis; coronaviral withdraw 5 days before
enteritis) susceptible to slaughter. For No. 069254,
oxytetracycline. zero-day withdrawal period.
----------------------------------------------------------------------------------------------------------------
(3) Swine--
----------------------------------------------------------------------------------------------------------------
Combination in
Oxytetracycline amount grams/ton Indications for use Limitations Sponsor
----------------------------------------------------------------------------------------------------------------
(i) 10 mg/lb of body weight .................. 1. Swine: For treatment Feed continuously for 066104
daily. of bacterial enteritis 7 to 14 days. 069254
caused by Escherichia
coli and Salmonella
choleraesuis
susceptible to
oxytetracycline and
treatment of bacterial
pneumonia caused by
Pasteurella multocida
susceptible to
oxytetracycline.
2. Breeding swine: For Feed continuously for 066104
control and treatment 14 days. 069254
of leptospirosis
(reducing the
incidence of abortion
and shedding of
leptospirae) caused by
Leptospira pomona
susceptible to
oxytetracycline.
(ii) 10 mg/lb of body Carbadox, 10 to 25 Swine: For treatment of Feed continuously as 066104
weight daily. bacterial enteritis the sole ration for 7
caused by E. coli and to 14 days. Not for
Salmonella use in pregnant swine
choleraesuis or swine intended for
susceptible to breeding purposes. Do
oxytetracycline and not mix in feeds
treatment of bacterial containing bentonite.
pneumonia caused by Do not feed to swine
Pasteurella multocida within 42 days of
susceptible to slaughter.
oxytetracycline; and Oxytetracycline and
for increased rate of carbadox as provided
weight gain and by No. 066104 in Sec.
improved feed 510.600(c) of this
efficiency. chapter.
----------------------------------------------------------------------------------------------------------------
(4) Cattle--
Page 95012
----------------------------------------------------------------------------------------------------------------
Combination in
Oxytetracycline amount grams/ton Indications for use Limitations Sponsor
----------------------------------------------------------------------------------------------------------------
(i) 10 mg/lb of body weight .................. 1. Calves and beef and Feed continuously for 066104
daily. nonlactating dairy 7 to 14 days. For No. 069254
cattle: For treatment 069254, withdraw 5
of bacterial enteritis days before
caused by Escherichia slaughter. For No.
coli and bacterial 066104, zero-day
pneumonia (shipping withdrawal period.
fever complex) caused
by Pasteurella
multocida susceptible
to oxytetracycline.
2. Calves: For Feed continuously for 066104
treatment of bacterial 7 to 14 days in milk 069254
enteritis caused by E. replacer or starter
coli susceptible to feed. This product is
oxytetracycline. not approved for use
in female dairy
cattle 20 months of
age or older,
including dry dairy
cows. Use in these
cattle may cause drug
residues in milk and/
or in calves born to
these cows. For No.
069254, withdraw 5
days before
slaughter. For No.
066104, zero-day
withdrawal period.
(ii) 75 mg/head/day........ .................. Growing cattle (over Feed continuously..... 066104
400 lb): For reduction 069254
of incidence of liver
abscesses.
(iii) 0.5 to 2.0 g/head/day .................. Cattle: For prevention Feed 3 to 5 days 066104
and treatment of the before and after 069254
early stages of arrival in feedlots.
shipping fever complex.
----------------------------------------------------------------------------------------------------------------
(5) Minor species--
----------------------------------------------------------------------------------------------------------------
Oxytetracycline amount Indications for use Limitations Sponsor
----------------------------------------------------------------------------------------------------------------
(i) 10 mg/lb of body weight daily... Sheep: For treatment of Feed continuously for 7 to 066104
bacterial enteritis caused 14 days; withdraw 5 days 069254
by E. coli and bacterial before slaughter.
pneumonia caused by P.
multocida susceptible to
oxytetracycline.
(ii) 200 mg/colony.................. Honey bees: For control of Remove at least 6 weeks 066104
American foulbrood caused prior to main honey flow. 069254
by Paenibacillus larvae and
European foulbrood caused
by Streptococcus pluton
susceptible to
oxytetracycline.
(iii) 250 mg/kilogram of fish/day Pacific salmon: For marking For salmon not over 30 g 066104
(11.35 g/100 lb of fish/day). of skeletal tissue. body weight; administer as
sole ration for 4
consecutive days; fish not
to be liberated for at
least 7 days following the
last administration of
medicated feed.
(iv) 2.5 to 3.75 g/100 lb of fish/ 1. Salmonids: For control of Administer in mixed ration 066104
day. ulcer disease caused by for 10 days; do not
Haemophilus piscium, liberate fish or slaughter
furunculosis caused by fish for food for 21 days
Aeromonas salmonicida, following the last
bacterial hemorrhagic administration of medicated
septicemia caused by A. feed.
liquefaciens, and
pseudomonas disease.
2. Catfish: For control of Administer in mixed ration 066104
bacterial hemorrhagic for 10 days; do not
septicemia caused by A. liberate fish or slaughter
liquefaciens and fish for food for 21 days
pseudomonas disease. following the last
administration of medicated
feed; do not administer
when water temperature is
below 16.7 degC (62
degF).
(v) 3.75 g/100 lb of fish/day....... 1. Freshwater-reared Administer in mixed ration 066104
salmonids: For control of for 10 days; do not
mortality due to coldwater liberate fish or slaughter
disease associated with fish for food for 21 days
Flavobacterium following the last
psychrophilum. administration of medicated
feed.
2. Freshwater-reared Administer in mixed ration 066104
Oncorhynchus mykiss: For for 10 days; do not
control of mortality due to liberate fish or slaughter
columnaris disease fish for food for 21 days
associated with following the last
Flavobacterium columnare. administration of medicated
feed.
(vi) 1 g/lb of medicated feed....... Lobsters: For control of Administer as sole ration 066104
gaffkemia caused by for 5 consecutive days;
Aerococcus viridans. withdraw medicated feed 30
days before harvesting
lobsters.
----------------------------------------------------------------------------------------------------------------
0
28. In Sec. 558.455, revise paragraph (d); remove and reserve paragraphs (e)(1)(i), (e)(2)(i), (e)(3)(i), (e)(4)(i), (e)(4)(ii), and (e)(4)(iv); and in paragraph (e)(4)(v), remove ``increased rate of weight gain; improved feed efficiency, and'' to read as follows:
Sec. 558.455 Oxytetracycline and neomycin.
* * * * *
(d) Special considerations--(1) Federal law restricts medicated feed containing this veterinary feed directive (VFD) drug to use by or on the order of a licensed veterinarian. See Sec. 558.6 for additional requirements.
(2) The expiration date of VFDs for oxytetracycline and neomycin
Page 95013
medicated feeds must not exceed 6 months from the date of issuance. VFDs for oxytetracycline and neomycin shall not be refilled.
(3) Cattle feeds shall bear the following warning statement: ``Use of more than one product containing neomycin or failure to follow withdrawal times may result in illegal drug residues.''
* * * * *
Sec. 558.460 Removed
0
29. Remove Sec. 558.460.
0
30. In Sec. 558.485, remove paragraphs (e)(1)(v) through (xii); and add paragraph (e)(3) to read as follows:
Sec. 558.485 Pyrantel.
* * * * *
(e) * * *
(3) Pyrantel may also be used in combination with:
(i) Lincomycin as in Sec. 558.325.
(ii) Tylosin as in Sec. 558.325.
0
31. In Sec. 558.500, remove and reserve paragraphs (e)(1)(ii), (iii), and (iv), (e)(2)(iv), (e)(2)(ix) and (x); remove paragraph (e)(2)(xiii); and add paragraph (e)(4) to read as follows:
Sec. 558.500 Ractopamine.
* * * * *
(e) * * *
(4) Ractopamine may also be used in combination with tylosin in as in Sec. 558.625.
0
32. In Sec. 558.515, in the table in paragraph (d), remove the row entries for ``Chlortetracycline 100 to 200'', ``Chlortetracycline 200 to 400'', ``Chlortetracycline 500'', ``Lincomycin 2'', and ``Oxytetracycline 400'' in the ``Combination in grams/ton'' column; and add paragraph (e) to read as follows:
Sec. 558.515 Robenidine.
* * * * *
(e) Robenidine may also be used in combination with:
(1) Chlortetracycline as in Sec. 558.128.
(2) Lincomycin as in Sec. 558.325.
(3) Oxytetracycline as in Sec. 558.450.
0
33. In Sec. 558.550, remove and reserve paragraphs (d)(1)(x), (d)(1)(xi), (d)(1)(xiii), and (d)(1)(xvi); and revise paragraph (d)(4) to read as follows:
Sec. 558.550 Salinomycin.
* * * * *
(d) * * *
(5) Salinomycin may also be used in combination with:
(i) Reserved
(ii) Reserved
(iii) Chlortetracycline as in Sec. 558.128.
(iv) Lincomycin as in Sec. 558.325.
(v) Oxytetracycline as in Sec. 558.450.
(vi) Virginiamycin as in Sec. 558.635.
0
34. In Sec. 558.555, remove paragraphs (d)(3) through (5); (e)(3) and (e)(4); remove and reserve paragraph (e)(2); and add paragraph (f) to read as follows:
Sec. 558.555 Semduramycin.
* * * * *
(f) Semduramycin may also be used in combination with virginiamycin as in Sec. 558.635.
0
35. In Sec. 558.575, revise the section heading; redesignate paragraphs (b), (c), and (d) as paragraphs (c), (d), and (e); revise paragraph (a); and add new paragraphs (b) and (d) to read as follows:
Sec. 558.575 Sulfadimethoxine and ormetoprim.
(a) Specifications. Type A medicated articles containing either:
(1) 25 percent sulfadimethoxine and 15 percent ormetoprim; or
(2) 25 percent sulfadimethoxine and 5 percent ormetoprim.
(b) Sponsors. See sponsors in Sec. 510.600(c) of this chapter for use as in paragraph (d) of this section:
(1) No. 054771 for use of the product described in paragraph (a)(1) as in paragraphs (e)(1), (e)(2), (e)(3), (e)(4), and (e)(7) of this section.
(2) No. 015331 for use of the product described in paragraph (a)(2) as in paragraphs (e)(5) and (e)(6) of this section.
* * * * *
(d) Special considerations.--(1) Federal law restricts medicated feed containing this veterinary feed directive (VFD) drug to use by or on the order of a licensed veterinarian. See Sec. 558.6 for additional requirements.
(2) The expiration date of VFDs for sulfadimethoxine and ormetoprim medicated feeds must not exceed 6 months from the date of issuance. VFDs for sulfadimethoxine and ormetoprim shall not be refilled.
* * * * *
0
36. Revise Sec. 558.582 to read as follows:
Sec. 558.582 Sulfamerazine.
(a) Specifications. Type A medicated articles containing 99 percent sulfamerazine.
(b) Sponsor. See No. 054771 in Sec. 510.600(c) of this chapter.
(c) Related tolerances. See Sec. 556.660 of this chapter.
(d) Special considerations--(1) Federal law restricts medicated feed containing this veterinary feed directive (VFD) drug to use by or on the order of a licensed veterinarian. See Sec. 558.6 for additional requirements.
(2) The expiration date of VFDs for sulfamerazine medicated feeds must not exceed 6 months from the date of issuance. VFDs for sulfamerazine shall not be refilled.
(e) Conditions of use. It is used in fish feed for as follows:
----------------------------------------------------------------------------------------------------------------
Combination in
Sulfamerazine grams/ton grams/ton Indications for use Limitations Sponsor
----------------------------------------------------------------------------------------------------------------
(1) To deliver 10 grams of .................. Rainbow trout, brook Formulate to deliver 054771
sulfamerazine per 100 trout, and brown 10 grams of
pounds of fish per day. trout: For control of sulfamerazine per 100
furunculosis. pounds of fish per
day. Treat for not
more than 14 days. Do
not treat within 3
weeks of marketing or
stocking in stream
open to fishing.
(2) Reserved..............
----------------------------------------------------------------------------------------------------------------
0
37. Revise Sec. 558.586 to read as follows:
Sec. 558.586 Sulfaquinoxaline.
(a) Specifications. Type A medicated articles containing 40 percent sulfaquinoxaline.
(b) Sponsor. See No. 016592 in Sec. 510.600(c) of this chapter.
(c) Related tolerances. See Sec. 556.685 of this chapter.
(d) Special considerations--(1) Federal law restricts medicated feed containing this veterinary feed directive (VFD) drug to use by or on the order of a licensed veterinarian. See Sec. 558.6 for additional requirements.
(2) The expiration date of VFDs for sulfaquinoxaline medicated feeds must not exceed 6 months from the date of issuance. VFDs for sulfaquinoxaline shall not be refilled.
(e) Conditions of use--(1) Chickens--
Page 95014
----------------------------------------------------------------------------------------------------------------
Sulfaquinoxaline in grams/ Combination in
ton grams/ton Indications for use Limitations Sponsor
----------------------------------------------------------------------------------------------------------------
(i) 0.015 percent.......... .................. As an aid in preventing Feed continuously from 016592
outbreaks of the time birds are
coccidiosis caused by placed on litter and
Eimeria tenella, E. continue past the age
necatrix, E. when coccidiosis is
acervulina, E. maxima, ordinarily a hazard.
and E. brunetti under If death losses
average conditions of exceed 0.5 percent in
exposure. a 2-day period,
obtain a laboratory
diagnosis. If
coccidiosis is the
cause, use the
sulfaquinoxaline
levels recommended
for control of
outbreaks, returning
to the original
dosage schedule after
the outbreak has
subsided. Losses may
result from
intercurrent disease,
other conditions
affecting drug
intake, or variant
strains of coccidia
species which can
contribute to the
virulence of
coccidiosis under
field conditions. Do
not treat chickens
within 10 days of
slaughter. Do not
medicate chickens
producing eggs for
human consumption.
(ii) 0.0175 percent........ .................. As an aid in preventing Feed continuously from 016592
outbreaks of the time birds are
coccidiosis caused by placed on litter and
Eimeria tenella, E. continue past the age
necatrix, E. when coccidiosis is
acervulina, E. maxima, ordinarily a hazard.
and E. brunetti where If death losses
excessive exposure to exceed 0.5 percent in
coccidia is increased a 2-day period,
due to overcrowding or obtain a laboratory
other management diagnosis. If
factors. coccidiosis is the
cause, use the
sulfaquinoxaline
levels recommended
for control of
outbreaks, returning
to the original
dosage schedule after
the outbreak has
subsided. Losses may
result from
intercurrent disease,
other conditions
affecting drug
intake, or variant
strains of coccidia
species which can
contribute to the
virulence of
coccidiosis under
field conditions. Do
not treat chickens
within 10 days of
slaughter. Do not
medicate chickens
producing eggs for
human consumption.
(iii) 0.1 to 0.05 percent.. .................. As an aid in Feed at 0.1 percent 016592
controlling outbreaks level for first 48 to
of coccidiosis caused 72 hours. Skip 3
by Eimeria tenella, E. days; 0.05 percent
necatrix, E. for 2 days, skip 3
acervulina, E. maxima, days; 0.05 percent
and E. brunetti. for 2 days. If bloody
droppings recur, give
0.05 percent for
another 2 days. Do
not treat chickens
within 10 days of
slaughter. Do not
medicate chickens
producing eggs for
human consumption.
(iv) 0.05 or 0.1 percent... .................. As an aid in the Feed 0.1 percent for 016592
control of acute fowl 48 to 72 hours.
cholera caused by Mortality should be
Pasteurella multocida brought under
susceptible to control. After
sulfaquinoxaline and medication, move
fowl typhoid caused by birds to clean ground
Salmonella gallinarum or to a clean house.
susceptible to If disease recurs,
sulfaquinoxaline. use 0.05 percent in
feed again for 2
days. Do not treat
chickens or turkeys
within 10 days of
slaughter for food.
Do not medicate
chickens or turkeys
producing eggs for
human consumption.
----------------------------------------------------------------------------------------------------------------
(2) Turkeys--
Page 95015
----------------------------------------------------------------------------------------------------------------
Sulfaquinoxaline in grams/ Combination in
ton grams/ton Indications for use Limitations Sponsor
----------------------------------------------------------------------------------------------------------------
(i) 0.0175 percent......... .................. As an aid in preventing Feed continuously 016592
outbreaks of during time birds are
coccidiosis caused by closely confined. May
Eimeria meleagrimitis be continued for a
and E. adenoeides. week to 10 days after
flock is transferred
to range to reduce
danger of an outbreak
following moving of
the flock. Do not
treat turkeys within
10 days of slaughter.
Do not medicate
turkeys producing
eggs for human
consumption.
(ii) 0.05 percent.......... .................. As an aid in Feed for 2 days. 016592
controlling outbreaks Follow with 3 days on
of coccidiosis caused regular feed and 2
by Eimeria more days on 0.05
meleagrimitis and E. percent
adenoeides. sulfaquinoxaline
feed. Again follow
with 3 days on
regular feed and 2
more days on 0.05
percent
sulfaquinoxaline
feed. Continue this
schedule if necessary
until all signs of
the outbreaks have
subsided. Do not
treat turkeys within
10 days of slaughter.
Do not medicate
turkeys producing
eggs for human
consumption.
(iii) 0.05 or 0.1 percent.. .................. As an aid in the Feed 0.1 percent for 016592
control of acute fowl 48 to 72 hours.
cholera caused by Mortality should be
Pasteurella multocida brought under
susceptible to control. After
sulfaquinoxaline and medication, move
fowl typhoid caused by birds to clean ground
Salmonella gallinarum or to a clean house.
susceptible to If disease recurs,
sulfaquinoxaline. use 0.05 percent in
feed again for 2
days. Do not treat
chickens or turkeys
within 10 days of
slaughter for food.
Do not medicate
chickens or turkeys
producing eggs for
human consumption.
----------------------------------------------------------------------------------------------------------------
(3) Rabbits--
----------------------------------------------------------------------------------------------------------------
Sulfaquinoxaline in grams/ Combination in
ton grams/ton Indications for use Limitations Sponsor
----------------------------------------------------------------------------------------------------------------
(i) 0.025 percent.......... .................. As an aid in preventing Treatment to be 016592
coccidiosis caused by started after
Eimeria stiedae. weaning. Feed
continuously for 30
days or feed
medicated feed for 2
days out of every
week until marketing.
Do not treat within
10 days of slaughter.
(ii) 0.1 percent........... .................. As an aid in Feed for 2 weeks. Do 016592
controlling outbreaks not treat within 10
of coccidiosis caused days of slaughter.
by Eimeria stiedae.
----------------------------------------------------------------------------------------------------------------
0
38. In Sec. 558.612, remove paragraphs (e)(1)(i) and (e)(1)(iii); redesignate paragraphs (e)(1)(ii) and (e)(1)(iv) as new paragraphs (e)(1)(i) and (ii); and add paragraph (e)(2) to read as follows:
Sec. 558.612 Tiamulin.
* * * * *
(e) * * *
(2) Tiamulin may also be used in combination with chlortetracycline as in Sec. 558.128.
0
39. Amend Sec. 558.625 as follows:
0
-
Remove paragraph (d);
0
-
Redesignate paragraphs (c), (e), and (f) as paragraphs (d), (c) and (e); and
0
-
Revise paragraph (b) and redesignated paragraphs (d) and (e).
The revisions read as follows:
Sec. 558.625 Tylosin.
* * * * *
(b) Sponsors. See sponsor numbers in Sec. 510.600(c) of this chapter.
(1) No. 016592: Type medicated article containing 100 grams per pound.
(2) No. 054771: Type medicated article containing 40 grams per pound.
(3) No. 058198: Type medicated article containing 10, 40, or 100 grams per pound.
(4) No. 066104: Type medicated article containing 20 or 40 grams per pound.
(c) Related tolerances. See Sec. 556.360 of this chapter.
(d) Special considerations--(1) Federal law restricts medicated feed containing this veterinary feed directive (VFD) drug to use by or on the order of a licensed veterinarian. See Sec. 558.6 for additional requirements.
(2) The expiration date of VFDs for oxytetracycline medicated feeds must not exceed 6 months from the date of issuance. VFDs for oxytetracycline shall not be refilled.
(3) Type C medicated feeds for cattle may be manufactured from tylosin liquid Type B medicated feeds which have a pH between 4.5 and 6.0 and which bear appropriate mixing directions as follows:
(i) For liquid feeds stored in recirculating tank systems: Recirculate immediately prior to use for not less than 10 minutes, moving not less than 1 percent of the tank contents per minute from the bottom of the tank to the top. Recirculate daily as described even when not used.
(ii) For liquid feeds stored in mechanical, air, or other agitation-type tank systems: Agitate immediately prior to use for not less than 10 minutes, creating a turbulence at the bottom of
Page 95016
the tank that is visible at the top. Agitate daily as described even when not used.
(e) Conditions of use--(1) Swine--
----------------------------------------------------------------------------------------------------------------
Combination in
Tylosin grams/ton grams/ton Indications for use Limitations Sponsors
----------------------------------------------------------------------------------------------------------------
(i) 40 or 100.............. .................. For control of swine Feed as the sole 016592
dysentery associated ration 100 g of 054771
with Brachyspira tylosin per ton of 058198
hyodysenteriae. complete feed for at 066104
least 3 weeks. Follow
with 40 grams per ton
of complete feed
until market weight.
(ii) 40 or 100............. Pyrantel, 96...... For control of swine Feed as the sole 066104
dysentery associated ration 100 g of
with Brachyspira tylosin per ton of
hyodysenteriae; and as complete feed for at
an aid in the least 3 weeks. Follow
prevention of with 40 grams per ton
migration and of complete feed
establishment of large until market weight.
roundworm (Ascaris Tylosin phosphate and
suum) infections; aid pyrantel as provided
in the prevention of by No. 066104 in Sec.
establishment of 510.600(c) of this
nodular worm chapter.
(Oesophagostomum spp.)
infections.
(iii) 40 or 100............ .................. For control of porcine Feed as the sole 016592
proliferative ration 100 g of 054771
enteropathies tylosin per ton of 058198
(ileitis) associated complete feed for at 066104
with Lawsonia least 3 weeks. Follow
intracellularis. with 40 grams per ton
of complete feed
until market weight.
(iv) 40 or 100............. Pyrantel, 96...... For control of porcine Feed as the sole 066104
proliferative ration 100 g of
enteropathies tylosin per ton of
(ileitis) associated complete feed for at
with Lawsonia least 3 weeks. Follow
intracellularis; and with 40 grams per ton
as an aid in the of complete feed
prevention of until market weight.
migration and Tylosin phosphate and
establishment of large pyrantel as provided
roundworm (Ascaris by No. 066104 in Sec.
suum) infections; aid 510.600(c) of this
in the prevention of chapter.
establishment of
nodular worm
(Oesophagostomum spp.)
infections.
(v) 40 or 100.............. Ractopamine, 4.5 Finishing swine: For Feed continuously as 016592
to 9.0. the control of swine the sole ration to 054771
dysentery associated finishing swine 058198
with Brachyspira weighing not less
hyodysenteriae; for than 150 lbs for the
control of porcine last 45 to 90 lbs
proliferative (group average) of
enteropathies weight gain prior to
(ileitis) associated slaughter. Include
with Lawsonia 100 g/ton of tylosin
intracellularis; and for at least 3 weeks,
for increased rate of followed by 40 g/ton
weight gain, improved until market weight.
feed efficiency, and Tylosin phosphate as
increased carcass provided by Nos.
leanness in finishing 058198 and 016592;
swine weighing not ractopamine as
less than 150 lbs, fed provided by Nos.
a complete ration 058198 and 054771 in
containing at least Sec. 510.600(c) of
16% crude protein for this chapter.
the last 45 to 90 lbs
of gain prior to
slaughter.
(vi) 40 to 100............. .................. For the treatment and Administer as tylosin 016592
control of swine phosphate in feed 054771
dysentery associated continuously as the 058198
with Brachyspira sole ration for 2 to 066104
hyodysenteriae 6 weeks, immediately
immediately after after treatment with
medicating with tylosin tartrate in
tylosin in drinking drinking water for 3
water. to 10 days as in Sec.
520.2640(d)(3) of
this chapter.
(vii) 40 to 100............ Pyrantel, 96...... For the treatment and Administer as tylosin 066104
control of swine phosphate in feed
dysentery associated continuously as the
with Brachyspira sole ration for 2 to
hyodysenteriae 6 weeks, immediately
immediately after after treatment with
medicating with tylosin tartrate in
tylosin in drinking drinking water for 3
water; and as an aid to 10 days as in Sec.
in the prevention of 520.2640(d)(3) of
migration and this chapter. Tylosin
establishment of large phosphate and
roundworm (Ascaris pyrantel as provided
suum) infections; aid by No. 066104 in Sec.
in the prevention of 510.600(c) of this
establishment of chapter.
nodular worm
(Oesophagostomum spp.)
infections.
(viii) 40 to 100........... .................. For the control of Administer as tylosin 016592
porcine proliferative phosphate in feed 054771
enteropathies (PPE, continuously as the 058198
ileitis) associated sole ration for 2 to 066104
with Lawsonia 6 weeks, immediately
intracellularis after treatment with
immediately after tylosin tartrate in
medicating with drinking water for 3
tylosin in drinking to 10 days as in Sec.
water. 520.2640(d)(3) of
this chapter.
Page 95017
(ix) 40 to 100............. Pyrantel, 96...... For the control of Administer as tylosin 066104
porcine proliferative phosphate in feed
enteropathies (PPE, continuously as the
ileitis) associated sole ration for 2 to
with Lawsonia 6 weeks, immediately
intracellularis after treatment with
immediately after tylosin tartrate in
medicating with drinking water for 3
tylosin in drinking to 10 days as in Sec.
water; and as an aid 520.2640(d)(3) of
in the prevention of this chapter. Tylosin
migration and phosphate and
establishment of large pyrantel as provided
roundworm (Ascaris by No. 066104 in Sec.
suum) infections; aid 510.600(c) of this
in the prevention of chapter.
establishment of
nodular worm
(Oesophagostomum spp.)
infections.
(x) 40 to 100.............. Ractopamine, 4.5 Finishing swine: For Feed continuously as 016592
to 9.0. the treatment and the sole ration to 054771
control of swine finishing swine 058198
dysentery associated weighing not less
with Brachyspira than 150 lbs for the
hyodysenteriae, for last 45 to 90 lbs
control of porcine (group average) of
proliferative weight gain prior to
enteropathies (PPE, slaughter. Include 40
ileitis) associated to 100 grams of
with Lawsonia tylosin phosphate per
intracellularis; and ton of complete feed
for increased rate of for 2 to 6 weeks,
weight gain, improved immediately after
feed efficiency, and treatment with
increased carcass tylosin tartrate in
leanness in finishing drinking water for 3
swine weighing not to 10 days as in Sec.
less than 150 lbs, fed 520.2640(d)(3) of
a complete ration this chapter. Tylosin
containing at least phosphate as provided
16% crude protein for by Nos. 058198 and
the last 45 to 90 lbs 016592; ractopamine
of gain prior to as provided by Nos.
slaughter. 058198 and 054771 in
Sec. 510.600(c) of
this chapter.
(xi) 100................... .................. For reduction in Feed continuously as 016592
severity of effects of the sole ration. 054771
atrophic rhinitis. 058198
066104
(xii) 100.................. Pyrantel, 96...... For reduction in Feed continuously as 066104
severity of effects of the sole ration.
atrophic rhinitis; aid Tylosin phosphate and
as an aid in the pyrantel as provided
prevention of by No. 066104 in Sec.
migration and 510.600(c) of this
establishment of large chapter. Tylosin
roundworm (Ascaris phosphate and
suum) infections; aid pyrantel as provided
in the prevention of by No. 066104 in Sec.
establishment of 510.600(c) of this
nodular worm chapter.
(Oesophagostomum spp.)
infections.
(xiii) 100................. Ractopamine, 4.5 For the control of Feed continuously as 016592
to 9.0. porcine proliferative the sole ration to 054771
enteropathies (PPE, finishing swine 058198
ileitis) associated weighing not less
with Lawsonia than 150 lbs for the
intracellularis; and last 45 to 90 lbs
for increased rate of (group average) of
weight gain, improved weight gain prior to
feed efficiency, and slaughter. Include
increased carcass 100 g/ton of tylosin
leanness in finishing for 3 weeks. Tylosin
swine weighing not phosphate as provided
less than 150 lbs, fed by Nos. 058198 and
a complete ration 016592; ractopamine
containing at least as provided by Nos.
16% crude protein for 058198 and 054771 in
the last 45 to 90 lbs Sec. 510.600(c) of
of gain prior to this chapter.
slaughter.
----------------------------------------------------------------------------------------------------------------
(2) Cattle--
----------------------------------------------------------------------------------------------------------------
Combination in
Tylosin grams/ton grams/ton Indications for use Limitations Sponsors
----------------------------------------------------------------------------------------------------------------
(i) 8 to 10................ .................. Beef cattle: For Feed continuously as 016592,
reduction of incidence the sole ration to 054771,
of liver abscesses provide 60 to 90 mg/ 058198, 066104
caused by head/day tylosin.
Fusobacterium
necrophorum and
Arcanobacterium
(Actinomyces) pyogenes.
Page 95018
(ii) 90 to 360............. Lasalocid, 100 to Heifers fed in Feed continuously as 054771
1440 plus confinement for sole ration. Feed to 016592
melengestrol, slaughter: For heifers at the rate
0.25 to 2.0. reduction of incidence of 0.5 to 2.0
of liver abscesses pound(s) per head per
caused by day (specify one
Fusobacterium level) to provide
necrophorum and 0.25 to 0.5 mg
Arcanobacterium melengestrol acetate
pyogenes; and for per head per day
increased rate of (specify one level),
weight gain, improved 100 to 360 mg
feed efficiency, and lasalocid per head
suppression of estrus per day (specify one
(heat). level), and 90 mg
tylosin per head per
day. This Type C
product may be top
dressed onto or mixed
into a complete feed
prior to feeding.
Tylosin as provided
by Nos. 058198 and
016592; lasalocid as
provided by No.
054771; melengestrol
as provided by Nos.
054771 and 058198 in
Sec. 510.600(c) of
this chapter.
(iii) 90 to 360............ Melengestrol, 0.25 Heifers fed in Feed continuously as 054771
to 2.0. confinement for sole ration. Each
slaughter: For pound contains 0.125
reduction of incidence to 1.0 mg
of liver abscesses melengestrol acetate
caused by and 45 to 180 mg of
Fusobacterium tylosin. Feed to
necrophorum and heifers at a rate of
Arcanobacterium 0.5 to 2.0 pounds per
pyogenes; and for head per day to
increased rate of provide 0.25 to 0.5
weight gain, improved mg melengestrol
feed efficiency, and acetate and 60 to 90
suppression of estrus mg tylosin per head
(heat). per day. Prior to
feeding, this Type C
product must be top-
dressed onto a
complete feed or
mixed into the amount
of complete feed
consumed by an animal
per day. Tylosin
provided by No.
058198; melengestrol
provided by No.
054771 in Sec.
510.600(c) of this
chapter.
(iv) 8 to 10............... Monensin, 5 to 40. Cattle fed in Feed continuously as 016592
confinement for sole ration to 058198
slaughter: For provide 50 to 480
reduction of incidence monensin mg/head/day
of liver abscesses and 60 to 90 mg/head/
caused by day tylosin. A
Fusobacterium withdrawal time has
necrophorum and not been established
Arcanobacterium for pre-ruminating
(Actinomyces) calves. Do not use in
pyogenes; and for calves to be
improved feed processed for veal.
efficiency. Tylosin provided by
Nos. 016592 or
058198; monensin as
provided by No.
058198 in Sec.
510.600(c) of this
chapter.
(v) 8 to 10................ Monensin, 10 to 40 Cattle fed in Feed continuously as 016592
confinement for sole ration to 058198
slaughter: For provide 0.14 to 0.42
reduction of incidence mg monensin/lb body
of liver abscesses weight per day,
caused by depending on the
Fusobacterium severity of the
necrophorum and coccidiosis
Arcanobacterium challenge, up to 480
(Actinomyces) mg/head/day and 60 to
pyogenes; and for 90 mg/head/day
prevention of tylosin. A withdrawal
coccidiosis caused by time has not been
Eimeria bovis and E established for pre-
zuernii. ruminating calves. Do
not use in calves to
be processed for
veal. Tylosin
provided by Nos.
016592 or 058198;
monensin as provided
by No. 058198 in Sec.
510.600(c) of this
chapter.
(vi) 8 to 10............... Monensin, 5 to 30 Cattle fed in Feed continuously as 016592
plus decoquinate, confinement for the sole ration to 054771
13.6 to 22.7. slaughter: For provide 22.7 mg of
reduction of incidence decoquinate per 100
of liver abscesses lb body weight per
caused by day, 50 to 360 mg of
Fusobacterium monensin/head/day,
necrophorum and and 60 to 90 mg of
Arcanobacterium tylosin/head/day.
pyogenes; for the Feed at least 28 days
prevention of during period of
coccidiosis caused by exposure to
Eimeria bovis and E. coccidiosis or when
zuernii; and for it is likely to be a
improved feed hazard. Do not feed
efficiency. to animals producing
milk for food. Do not
feed to lactating
dairy cattle. A
withdrawal time has
not been established
for pre-ruminating
calves. Do not use in
calves to be
processed for veal.
Tylosin as provided
by Nos. 016592 and
058198; monensin as
provided by No.
058198; decoquinate
as provided by No.
058198 in Sec.
510.600(c) of this
chapter.
Page 95019
(vii) 8 to 10.............. Monensin, 10 to 40 Heifers fed in Feed continuously as 016592
plus confinement for sole ration to 054771
melengestrol, slaughter: For heifers at a rate of 058198
0.25 to 2.0. reduction of incidence 0.5 to 2.0 pounds per
of liver abscesses head per day to
caused by provide 0.25 to 0.5
Fusobacterium mg/head/day
necrophorum and melengestrol acetate
Arcanobacterium and 0.14 to 0.42 mg
(Actinomyces) monensin/lb body
pyogenes; for weight per day,
prevention and control depending on the
of coccidiosis caused severity of the
by Eimeria bovis and E coccidiosis
zuernii; and for challenge, up to 480
increased rate of mg/head/day and 60 to
weight gain, improved 90 mg/head/day
feed efficiency, and tylosin. The
suppression of estrus melengestrol acetate
(heat). portion of this Type
C medicated feed must
be mixed into the
complete feed
containing 10 to 40 g/
ton monensin and 8 to
10 g/ton tylosin at
feeding into the
amount of complete
feed consumed by an
animal per day. A
withdrawal time has
not been established
for pre-ruminating
calves. Do not use in
calves to be
processed for veal.
Tylosin provided by
Nos. 016592 or
058198; monensin as
provided by No.
058198; melengestrol
provided by Nos.
054771 or 058198 in
Sec. 510.600(c) of
this chapter.
(viii) 8 to 10............. Monensin, 10 to 40 Cattle fed in Feed continuously as 054771
plus ractopamine, confinement for sole ration to 058198
8.2 to 24.6. slaughter: For provide 70 to 430 mg/
reduction of incidence head/day ractopamine
of liver abscesses and 0.14 to 0.42 mg
caused by monensin/lb body
Fusobacterium weight per day,
necrophorum and depending on the
Arcanobacterium severity of the
pyogenes; for coccidiosis
prevention and control challenge, up to 480
of coccidiosis caused mg/head/day and 60 to
by Eimeria bovis and E 90 mg/head/day
zuernii; and for tylosin for the last
increased rate of 28 to 42 days on
weight gain and feed. A withdrawal
improved feed time has not been
efficiency in cattle established for pre-
fed in confinement for ruminating calves. Do
slaughter for the last not use in calves to
28 to 42 days on feed. be processed for
veal. Tylosin
provided by Nos.
016592 or 058198;
monensin as provided
by No. 058198;
ractopamine provided
by Nos. 054771 or
058198 in Sec.
510.600(c) of this
chapter.
(ix) 8 to 10............... Monensin, 10 to 40 Cattle fed in Feed a minimum of 1.0 054771
plus ractopamine, confinement for lb/head/day 058198
not to exceed 800. slaughter: For ractopamine Type C
reduction of incidence top dress feed
of liver abscesses continuously to
caused by cattle fed in
Fusobacterium confinement for
necrophorum and slaughter, to provide
Arcanobacterium 70 to 400 mg/head/day
pyogenes; for ractopamine for the
prevention and control last 28 to 42 days on
of coccidiosis caused feed. Feed on top of
by Eimeria bovis and E a ration containing
zuernii; and for 10 to 40 g/ton
increased rate of monensin and 8 to 10
weight gain and g/ton tylosin
improved feed phosphate, to provide
efficiency in cattle 0.14 to 0.42 mg
fed in confinement for monensin/lb body
slaughter for the last weight/day, depending
28 to 42 days on feed. on the severity of
the coccidiosis
challenge, up to 480
mg/head/day and 60 to
90 mg/head/day
tylosin. A withdrawal
time has not been
established for pre-
ruminating calves. Do
not use in calves to
be processed for
veal. Tylosin
provided by Nos.
016592 or 058198;
monensin as provided
by No. 058198;
ractopamine provided
by Nos. 054771 or
058198 in Sec.
510.600(c) of this
chapter.
Page 95020
(x) 8 to 10................ Monensin 10 to 40 Cattle fed in Feed continuously as 054771
plus ractopamine confinement for sole ration to 058198
9.8 to 24.6. slaughter: For provide 90 to 430 mg/
reduction of incidence head/day ractopamine
of liver abscesses and 0.14 to 0.42 mg
caused by monensin/lb body
Fusobacterium weight per day,
necrophorum and depending on the
Arcanobacterium severity of the
pyogenes; for coccidiosis
prevention and control challenge, up to 480
of coccidiosis caused mg/head/day and 60 to
by Eimeria bovis and E 90 mg/head/day
zuernii; and for tylosin for the last
increased rate of 28 to 42 days on
weight gain, improved feed. A withdrawal
feed efficiency, and time has not been
increased carcass established for pre-
leanness in cattle fed ruminating calves. Do
in confinement for not use in calves to
slaughter for the last be processed for
28 to 42 days on feed. veal. Tylosin
provided by Nos.
016592 or 058198;
monensin as provided
by No. 058198;
ractopamine as
provided by Nos.
054771 or 058198 in
Sec. 510.600(c) of
this chapter.
(xi) 8 to 10............... Monensin, 10 to 40 Heifers fed in Feed continuously as 054771
plus ractopamine, confinement for sole ration to 058198
9.8 to 24.6 plus slaughter: For provide 90 to 430 mg/
melengestrol, reduction of incidence head/day ractopamine
0.125 to 1 mg/lb. of liver abscesses and 0.14 to 0.42 mg
caused by monensin/lb body
Fusobacterium weight per day,
necrophorum and depending on the
Arcanobacterium severity of the
(Actinomyces) coccidiosis
pyogenes; for challenge, up to 480
prevention and control mg/head/day and 60 to
of coccidiosis caused 90 mg/head/day
by Eimeria bovis and E tylosin for the last
zuernii; for increased 28 to 42 days on
rate of weight gain, feed. Feed
improved feed melengestrol as a top
efficiency, and dress or mixed with a
increased carcass complete ration at
leanness; and the rate of 0.5 to
suppression of estrus 2.0 pound/head/day
(heat). (specify one level)
to provide 0.25 to
0.5 mg melengestrol
acetate/head/day
(specify one level).
A withdrawal time has
not been established
for pre-ruminating
calves. Do not use in
calves to be
processed for veal.
Tylosin provided by
Nos. 016592 or
058198; monensin as
provided by No.
058198; ractopamine
as provided by Nos.
054771 or 058198 in
Sec. 510.600(c) of
this chapter.
(xii) 8 to 10.............. Monensin, 10 to 40 Cattle fed in Feed continuously as 000061
plus zilpaterol, confinement for the sole ration to 016592
6.8. slaughter: For cattle during the
reduction of incidence last 20 to 40 days on
of liver abscesses feed to provide 60 to
caused by 90 mg/head/day
Fusobacterium zilpaterol, 0.14 to
necrophorum and 0.42 mg/lb body
Arcanobacterium weight/day monensin,
pyogenes; for depending on the
prevention and control severity of the
of coccidiosis caused coccidiosis
by Eimeria bovis and E challenge, up to 480
zuernii; and for mg/head/day monensin,
increased rate of and 60 to 90 mg/head/
weight gain, improved day tylosin. Do not
feed efficiency, and use in veal calves.
increased carcass Withdrawal period 3
leanness in cattle fed days. Tylosin
in confinement for provided by Nos.
slaughter for the last 016592 or 058198;
20 to 40 days on feed. monensin as provided
by No. 058198;
zilpaterol as
provided by No.
000061 in Sec.
510.600(c) of this
chapter.
(xiii) 8 to 10............. Monensin, 10 to 40 Cattle fed in Feed this component 000061
plus zilpaterol, confinement for feed continuously to 016592
6.8 to 24. slaughter: For cattle during the
reduction of incidence last 20 to 40 days on
of liver abscesses feed to provide 60 mg/
caused by head/day zilpaterol,
Fusobacterium 0.14 to 0.42 mg/lb
necrophorum and body weight/day
Arcanobacterium monensin, depending
pyogenes; for on the severity of
prevention and control the coccidiosis
of coccidiosis caused challenge, up to 480
by Eimeria bovis and E mg/head/day monensin,
zuernii; and for and 60 to 90 mg/head/
increased rate of day tylosin. Do not
weight gain, improved use in veal calves.
feed efficiency, and Withdrawal period 3
increased carcass days. Tylosin
leanness in cattle fed provided by Nos.
in confinement for 016592 or 058198;
slaughter for the last monensin as provided
20 to 40 days on feed. by No. 058198;
zilpaterol as
provided by No.
000061 in Sec.
510.600(c) of this
chapter.
Page 95021
(xiv) 8 to 10.............. Monensin, 10 to 40 Heifers fed in Feed continuously as 000061
plus zilpaterol, confinement for the sole ration to 016592
6.8 plus slaughter: For cattle during the 058198
melengestrol, reduction of incidence last 20 to 40 days on
0.125 to 1 mg/lb. of liver abscesses feed to provide 60 to
caused by 90 mg/head/day
Fusobacterium zilpaterol, 0.14 to
necrophorum and 0.42 mg/lb body
Arcanobacterium weight/day monensin,
(Actinomyces) depending on the
pyogenes; for severity of the
prevention and control coccidiosis
of coccidiosis caused challenge, up to 480
by Eimeria bovis and E mg/head/day monensin,
zuernii; and for and 60 to 90 mg/head/
increased rate of day tylosin. Feed
weight gain, improved melengestrol as a top
feed efficiency, and dress or mixed with a
increased carcass complete ration at
leanness in cattle fed the rate of 0.5 to
in confinement for 2.0 pound/head/day
slaughter for the last (specify one level)
20 to 40 days on feed; to provide 0.25 to
and for suppression of 0.5 mg melengestrol
estrus (heat). acetate/head/day
(specify one level).
Do not use in veal
calves. Withdrawal
period 3 days.
Tylosin as provided
by Nos. 016592 or
058198; monensin as
provided by No.
058198; zilpaterol as
provided by No.
000061; melengestrol
provided by Nos.
054771 or 058198 in
Sec. 510.600(c) of
this chapter.
(xv) 8 to 10............... Monensin, 10 to 40 Heifers fed in Feed this component 000061
plus zilpaterol, confinement for feed continuously to 016592
6.8 to 24 plus slaughter: For cattle during the 058198
melengestrol, reduction of incidence last 20 to 40 days on
0.125 to 1 mg/lb. of liver abscesses feed to provide 60 mg/
caused by head/day zilpaterol,
Fusobacterium 0.14 to 0.42 mg/lb
necrophorum and body weight/day
Arcanobacterium monensin, depending
(Actinomyces) on the severity of
pyogenes; for the coccidiosis
prevention and control challenge, up to 480
of coccidiosis caused mg/head/day monensin,
by Eimeria bovis and E and 60 to 90 mg/head/
zuernii; and for day tylosin. Feed
increased rate of melengestrol as a top
weight gain, improved dress or mixed with a
feed efficiency, and complete ration at
increased carcass the rate of 0.5 to
leanness in cattle fed 2.0 pound/head/day
in confinement for (specify one level)
slaughter for the last to provide 0.25 to
20 to 40 days on feed; 0.5 mg melengestrol
and for suppression of acetate/head/day
estrus (heat). (specify one level).
Do not use in veal
calves. Withdrawal
period 3 days.
Tylosin as provided
by Nos. 016592 or
058198; monensin as
provided by No.
058198; zilpaterol as
provided by No.
000061; melengestrol
provided by Nos.
054771 or 058198 in
Sec. 510.600(c) of
this chapter.
----------------------------------------------------------------------------------------------------------------
0
40. Revise Sec. 558.630 to read as follows:
Sec. 558.630 Tylosin and sulfamethazine.
(a) Specifications. Type A medicated articles containing equal amounts of tylosin phosphate and sulfamethazine, available in concentrations of 5, 10, 20, or 40 grams each, per pound.
(b) Sponsors. See sponsor numbers in Sec. 510.600(c) of this chapter.
(1) No. 058198 for use as in paragraph (e)(1) of this section.
(2) No. 054771: 10 or 40 grams per pound each for use as in paragraph (e)(2) of this section.
(c) Related tolerances. See Sec. Sec. 556.670 and 556.740 of this chapter.
(d) Special considerations--(1) Federal law restricts medicated feed containing this veterinary feed directive (VFD) drug to use by or on the order of a licensed veterinarian. See Sec. 558.6 for additional requirements.
(2) The expiration date of VFDs for tylosin and sulfamethazine medicated feeds must not exceed 6 months from the date of issuance. VFDs for tylosin and sulfamethazine shall not be refilled.
(3) Labeling shall bear the statement: ``Do not use in medicated feeds containing in excess of 2% bentonite.''
(e) Conditions of use. It is used in feed for swine as follows:
Page 95022
----------------------------------------------------------------------------------------------------------------
Tylosin phosphate and Combination in
sulfamethazine in grams/ton grams/ton Indications for use Limitations Sponsors
----------------------------------------------------------------------------------------------------------------
(1) 100 each............... .................. For reduction in the Withdraw 15 days 058198
severity of effects of before swine are
atrophic rhinitis; slaughtered.
lowering the incidence
and severity of
Bordetella
bronchiseptica
rhinitis; prevention
of swine dysentery
associated with
Brachyspira
hyodysenteriae;
control of swine
pneumonias caused by
bacterial pathogens
(Pasteurella multocida
and/or Arcanobacterium
pyogenes); reducing
the incidence of
cervical lymphadenitis
(jowl abscesses)
caused by Group E
Streptococci. Only the
sulfamethazine portion
of this combination is
active in controlling
jowl abscesses.
(2) 100 each............... .................. For reduction in the Withdraw 15 days 054771
severity of effects of before swine are
atrophic rhinitis; slaughtered.
lowering the incidence
and severity of
Bordetella
bronchiseptica
rhinitis; prevention
of swine dysentery
associated with
Brachyspira
hyodysenteriae; and
control of swine
pneumonias caused by
bacterial pathogens
(Pasteurella multocida
and/or Arcanobacterium
pyogenes).
----------------------------------------------------------------------------------------------------------------
0
41. Revise Sec. 558.635 to read as follows:
Sec. 558.635 Virginiamycin.
(a) Specifications. Type A medicated articles containing 5, 10, 20, 50, 136.2, or 227 grams per pound virginiamycin.
(b) Sponsors. See No. 066104 in Sec. 510.600(c) of this chapter.
(c) Related tolerances. See Sec. 556.750 of this chapter.
(d) Special considerations--(1) Reserved
(2) Reserved
(3) Not for use in breeding swine over 120 pounds.
(4) Dilute Type A article with at least 10 pounds of a feed ingredient prior to final mixing in 1 ton of Type C feed.
(e) Conditions of use--(1) Chickens--
----------------------------------------------------------------------------------------------------------------
Combination in
Virginiamycin grams/ton grams/ton Indications for use Limitations Sponsors
----------------------------------------------------------------------------------------------------------------
(i) 5...................... .................. Broiler chickens: For Not for use in layers. 066104
increased rate of
weight gain and
improved feed
efficiency.
(ii) 5..................... Monensin, 90 to Broiler chickens: For Feed continuously as 066104
110. increased rate of the sole ration. Do
weight gain and not feed to laying
improved feed chickens.
efficiency; as an aid Virginiamycin as
in the prevention of provided by No.
coccidiosis caused by 066104; monensin as
Eimeria necatrix, E. provided by No.
tenella, E. 058198 in Sec.
acervulina, E. 510.600(c) of this
brunetti, E. maxima, chapter.
and E. mivati.
(iii) 5.................... Salinomycin, 40 to Broiler chickens: For Feed continuously as 066104
60. increased rate of the sole ration. Do 016592
weight gain and not feed to layers or
improved feed to chickens over 16
efficiency; for weeks of age. Not
prevention of approved for use with
coccidiosis caused by pellet binders. May
Eimeria tenella, E. be fatal if
necatrix, E. accidentally fed to
acervulina, E. maxima, adult turkeys or
E. brunetti, and E. horses. Virginiamycin
mivati. as provided by No.
066104; salinomycin
as provided by No.
054771 in Sec.
510.600(c) of this
chapter.
(iv) 5..................... Semduramicin, 22.7 Broiler chickens: For Feed continuously as 066104
increased rate of the sole ration. Do
weight gain and not feed to laying
improved feed hens. Semduramicin as
efficiency; for the provided by No.
prevention of 066104 in Sec.
coccidiosis caused by 510.600(c) of this
Eimeria acervulina, E. chapter.
brunetti, E. maxima,
E. mivati/mitis, E.
necatrix, and E.
tenella.
(v) 5...................... Semduramicin Broiler chickens: For Feed continuously as 066104
(biomass), 22.7. increased rate of the sole ration.
weight gain and Withdraw 1 day before
improved feed slaughter. Do not
efficiency; for the feed to laying hens.
prevention of Virginiamycin and
coccidiosis caused by semduramicin as
Eimeria acervulina, E. provided by No.
brunetti, E. maxima, 066104 in Sec.
E. mivati/mitis, E. 510.600(c) of this
necatrix, and E. chapter.
tenella.
(vi) 5 to 15............... Broiler chickens: For Not for use in layers. 066104
increased rate of
weight gain.
Page 95023
(vii) 5 to 15.............. Amprolium, 113.5 Broiler chickens: For Feed continuously as 066104
and ethopabate, increased rate of the sole ration and
36.3. weight gain; as an aid as the sole source of
in the prevention of amprolium. Do not
coccidiosis where feed to laying
severe exposure to chickens. Not for
coccidiosis from chickens over 16
Eimeria acervulina, E. weeks of age.
maxima, and E. Virginiamycin as
brunetti is likely to provided by No.
occur. 066104; amprolium and
ethopabate as
provided by No.
016592 in Sec.
510.600(c) of this
chapter.
(viii) 5 to 15............. Monensin, 90 to Broiler chickens: For Feed continuously as 066104
110. increased rate of the sole ration. Do
weight gain; as an aid not feed to laying
in the prevention of chickens. Monensin as
coccidiosis caused by provided by No.
Eimeria necatrix, E. 000986 in Sec.
tenella, E. 510.600(c) of this
acervulina, E. chapter.
brunetti, E. maxima,
and E. mivati.
(ix) 5 to 15............... Salinomycin, 40 to Broiler chickens: For Feed continuously as 016592
60. increased rate of the sole ration. Do 066104
weight gain; as an aid not feed to layers or
in the prevention of to chickens over 16
coccidiosis caused by weeks of age. Not
Eimeria tenella, E. approved for use with
necatrix, E. pellet binders. May
acervulina, E. maxima, be fatal if
E. brunetti, and E. accidentally fed to
mivati. adult turkeys or
horses. Virginiamycin
as provided by No.
066104; salinomycin
as provided by Nos.
016592 or 054771 in
Sec. 510.600(c) of
this chapter.
(x) 5 to 15................ Semduramicin, 22.7 Broiler chickens: For Feed continuously as 066104
increased rate of the sole ration. Do
weight gain; for the not feed to laying
prevention of hens. Semduramicin as
coccidiosis caused by provided by No.
Eimeria acervulina, E. 066104 in Sec.
brunetti, E. maxima, 510.600(c) of this
E. mivati/mitis, E. chapter.
necatrix, and E.
tenella.
(xi) 5 to 15............... Semduramicin Broiler chickens: For Feed continuously as 066104
(biomass), 22.7. increased rate of the sole ration.
weight gain; for the Withdraw 1 day before
prevention of slaughter. Do not
coccidiosis caused by feed to laying hens.
Eimeria acervulina, E. Virginiamycin as
brunetti, E. maxima, E provided by No.
mivati/mitis, E. 066104; semduramicin
necatrix, and E. as provided by No.
tenella. 066104 in Sec.
510.600(c) of this
chapter.
(xii) 15................... Amprolium, 113.5 Broiler chickens: For Feed continuously as 066104
and ethopabate, increased rate of the sole ration and
36.3. weight gain and as the sole source of
improved feed amprolium. Do not
efficiency; as an aid feed to laying
in the prevention of chickens. Not for
coccidiosis where chickens over 16
severe exposure to weeks of age.
coccidiosis from Virginiamycin as
Eimeria acervulina, E. provided by No.
maxima, and E. 066104; amprolium and
brunetti is likely to ethopabate as
occur. provided by No.
016592 in Sec.
510.600(c) of this
chapter.
(xiii) 20.................. Broiler chickens: For Not for use in layers. 066104
prevention of necrotic
enteritis caused by
Clostridium spp.
susceptible to
virginiamycin.
(xiv) 20................... Lasalocid, 68 to Broiler chickens: For Feed continuously as 066104
113. increased rate of the sole ration. Do
weight gain and not feed to laying
improved feed chickens. Lasalocid
efficiency; for sodium as provided by
prevention of No. 054771 in Sec.
coccidiosis caused by 510.600(c) of this
Eimeria tenella, E. chapter.
necatrix, E.
acervulina, E.
brunetti, E. mivati,
and E. maxima.
(xv) 20.................... Monensin, 90 to Broiler chickens: For Feed continuously as 066104
110. prevention of necrotic the sole ration. Do
enteritis caused by not feed to laying
Clostridium spp. chickens. Monensin as
susceptible to provided by No.
virginiamycin; and as 058198 in Sec.
an aid in the 510.600(c) of this
prevention of chapter.
coccidiosis caused by
Eimeria necatrix, E.
tenella, E.
acervulina, E.
brunetti, E. maxima,
and E. mivati.
(xvi) 20................... Semduramicin, 22.7 Broiler chickens: For Feed continuously as 066104
prevention of necrotic the sole ration. Do
enteritis caused by not feed to laying
Clostridium spp. hens. Semduramicin as
susceptible to provided by No.
virginiamycin; for the 066104 in Sec.
prevention of 510.600(c) of this
coccidiosis caused by chapter.
Eimeria acervulina, E.
brunetti, E. maxima,
E. mivati/mitis, E.
necatrix, and E.
tenella.
(xvii) 20.................. Semduramicin Broiler chickens: For Feed continuously as 066104
(biomass), 22.7. prevention of necrotic the sole ration.
enteritis caused by Withdraw 1 day before
Clostridium spp. slaughter. Do not
susceptible to feed to laying hens.
virginiamycin; for the Semduramicin as
prevention of provided by No.
coccidiosis caused by 066104 in Sec.
Eimeria acervulina, E. 510.600(c) of this
brunetti, E. maxima, chapter.
E. mivati/mitis, E.
necatrix, and E.
tenella.
----------------------------------------------------------------------------------------------------------------
Page 95024
(2) Turkeys--
----------------------------------------------------------------------------------------------------------------
Combination in
Virginiamycin grams/ton grams/ton Indications for use Limitations Sponsors
----------------------------------------------------------------------------------------------------------------
(i) 10 to 20............... .................. Growing turkeys: For Not for use in layers. 066104
increased rate of
weight gain and
improved feed
efficiency.
(ii) 10 to 20.............. Lasalocid, 68 to Growing turkeys: For Lasalocid sodium as 054771
113. increased rate of provided by No.
weight gain and 054771 in Sec.
improved feed 510.600(c) of this
efficiency; and for chapter.
the prevention of
coccidiosis caused by
Eimeria meleagrimitis,
E. gallopavonis, and
E. adenoeides.
(iii) 10 to 20............. Monensin, 90 to Growing turkeys: For Monensin as provided 066104
110. increased rate of by No. 058198 in Sec.
weight gain and 510.600(c) of this
improved feed chapter.
efficiency; and for
the prevention of
coccidiosis caused by
Eimeria meleagrimitis,
E. gallopavonis, and
E. adenoeides.
----------------------------------------------------------------------------------------------------------------
(3) Swine--
----------------------------------------------------------------------------------------------------------------
Combination in
Virginiamycin grams/ton grams/ton Indications for use Limitations Sponsors
----------------------------------------------------------------------------------------------------------------
(i) 5 or 10................ .................. Growing-finishing Feed continuously from 066104
swine: For increased weaning to market
rate of weight gain weight. Feed 10 grams
and improved feed per ton from weaning
efficiency. up to 120 pounds,
followed by 5 grams
per ton to market
weight.
(ii) 5 to 10............... .................. Growing-finishing Feed continuously from 066104
swine: For increased weaning to market
rate of weight gain. weight. Feed 10 grams
per ton from weaning
up to 120 pounds for
increased rate of
weight gain and
improved feed
efficiency, followed
by 5 to 10 grams per
ton to market weight
for increased rate of
weight gain.
(iii) 25................... .................. Growing-finishing ...................... 066104
swine: As an aid in
control of dysentery
in swine up to 120
pounds in animals or
on premises with a
history of swine
dysentery but where
symptoms have not yet
occurred.
(iv) 50 or 100............. .................. Growing-finishing Feed 100 grams per ton 066104
swine: For treatment for 2 weeks, 50 grams
and control of swine per ton thereafter.
dysentery in swine up
to 120 pounds.
(v) 100.................... .................. Growing-finishing Feed for 2 weeks...... 066104
swine: For treatment
of swine dysentery in
nonbreeding swine over
120 pounds.
----------------------------------------------------------------------------------------------------------------
(4) Cattle--
----------------------------------------------------------------------------------------------------------------
Combination in
Virginiamycin grams/ton grams/ton Indications for use Limitations Sponsors
----------------------------------------------------------------------------------------------------------------
(i) 11.0 to 16.0........... .................. Cattle fed in Feed continuously as 066104
confinement for the sole ration to
slaughter: For provide 70 to 240
improved feed milligrams per head
efficiency. per day. Not for use
in animals intended
for breeding.
(ii) 13.5 to 16.0.......... .................. Cattle fed in Feed continuously as 066104
confinement for the sole ration to
slaughter: For provide 85 to 240
reduction of incidence milligrams per head
of liver abscesses. per day. Not for use
in animals intended
for breeding.
(iii) 16.0 to 22.5......... .................. Cattle fed in Feed continuously as 066104
confinement for the sole ration to
slaughter: For provide 100 to 340
increased rate of milligrams per head
weight gain. per day. Not for use
in animals intended
for breeding.
----------------------------------------------------------------------------------------------------------------
Page 95025
0
42. In Sec. 558.665, remove and reserve paragraphs (e)(5) and (6); remove paragraphs (e)(11) and (12); and add paragraph (f) to read as follows:
Sec. 558.665 Zilpaterol.
* * * * *
(f) Zilpaterol may also be used in combination with tylosin as in Sec. 558.625.
0
43. In Sec. 558.680, remove paragraph (d)(1)(x); and add paragraph (e)(3) to read as follows:
Sec. 558.680 Zoalene.
* * * * *
(e) * * *
(3) Zoalene may also be used in combination with lincomycin as in Sec. 558.325.
Dated: December 20, 2016.
Tracey H. Forfa,
Deputy Director, Center for Veterinary Medicine.
FR Doc. 2016-31083 Filed 12-23-16; 8:45 am
BILLING CODE 4164-01-P
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