[Federal Register Volume 79, Number 39 (Thursday, February 27, 2014)]
[Rules and Regulations]
[Pages 10976-10985]
[FR Doc No: 2014-02617]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 556 and 558

[Docket No. FDA-2014-N-0002]

Zoetis Inc., et al.; Withdrawal of Approval of New Animal Drug
Applications for Combination Drug Medicated Feeds Containing an
Arsenical Drug

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule; technical amendments.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is amending the animal
drug regulations to reflect the withdrawal of approval of 69 new animal
drug applications (NADAs) and 22 abbreviated new animal drug
applications (ANADAs) for use of arsanilic acid, carbarsone, or
roxarsone Type A medicated articles to manufacture combination drug
Type B and Type C medicated feeds. This action is being taken at the
sponsor's request because the products are no longer manufactured or
marketed. FDA is also amending the animal drug regulations to remove
entries describing conditions of use for combination drug medicated
feeds for which no NADA is approved. This action is being taken to
improve the accuracy of the regulations.

DATES: This rule is effective March 10, 2014.

FOR FURTHER INFORMATION CONTACT: John Bartkowiak, Center for Veterinary
Medicine (HFV-212), Food and Drug Administration, 7519 Standish Pl.,
Rockville, MD 20855,<PHONE_NUMBER><EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Recently, the Agency provided notice of the
withdrawal of approval of NADAs for Type A medicated articles
containing

arsanilic acid, carbarsone, and roxarsone and revoked applicable
regulations for their conditions of use to manufacture single-
ingredient medicated feeds in 21 CFR part 558 New Animal Drugs For Use
in Animal Feeds (78 FR 70062, Nov. 22, 2013; 78 FR 69992, Nov. 22,
2013; 78 FR 70566, Nov. 26, 2013; 78 FR 70496, Nov. 26, 2013).
    Subsequently, the following six sponsors of NADAs and ANADAs
permitting use of arsanilic acid, carbarsone, or roxarsone Type A
medicated articles to manufacture combination drug Type B and Type C
medicated feeds requested that FDA withdraw approval of their
applications because these combination medicated feeds are no longer
manufactured or marketed.
     Zoetis Inc., 333 Portage St., Kalamazoo, MI 49007 has
requested that FDA withdraw approval of the following 39 NADAs and 11
ANADAs:

------------------------------------------------------------------------
        NADA/ANADA                  Ingredient new animal drugs
------------------------------------------------------------------------
040-435..................  3-NITRO (roxarsone)/DECCOX (decoquinate).
041-178..................  Roxarsone/AMPROL Plus (amprolium and
                            ethopabate)/LINCOMIX (lincomycin).
041-984..................  Roxarsone/ROFENAID (sulfadimethoxine/
                            ormetoprim).
091-326..................  3-NITRO (roxarsone)/DECCOX (decoquinate)/
                            ALBAC (bacitracin zinc).
092-522..................  Roxarsone/COBAN (monensin)/LINCOMIX
                            (lincomycin).
095-546..................  Roxarsone/ROBENZ (robenidine).
102-485..................  3-NITRO (roxarsone)/AVATEC (lasalocid).
105-758..................  3-NITRO (roxarsone)/AMPROL HI-E (amprolium
                            and ethopabate)/BACIFERM (bacitracin zinc).
112-661..................  3-NITRO (roxarsone)/AVATEC (lasalocid)/
                            LINCOMIX (lincomycin).
112-687..................  3-NITRO (roxarsone)/AVATEC (lasalocid)/
                            FLAVOMYCIN (bambermycins).
116-082..................  3-NITRO (roxarsone)/AVATEC (lasalocid)/BMD
                            (bacitracin MD).
116-088..................  3-NITRO (roxarsone)/COBAN (monensin)/BMD
                            (bacitracin MD).
123-154..................  3-NITRO (roxarsone)/BACIFERM (bacitracin
                            zinc)/COBAN (monensin).
126-052..................  3-NITRO (roxarsone)/AVATEC (lasalocid)/
                            BACIFERM (bacitracin zinc).
131-894..................  3-NITRO (roxarsone)/AVATEC (lasalocid)/
                            bacitracin MD.
132-447..................  Roxarsone/BIO-COX (salinomycin).
134-185..................  3-NITRO (roxarsone)/BIO-COX (salinomycin)/
                            FLAVOMYCIN (bambermycins).
135-321..................  3-NITRO (roxarsone)/BIO-COX (salinomycin)/BMD
                            (bacitracin MD).
137-536..................  3-NITRO (roxarsone)/BIO-COX/ALBAC (bacitracin
                            zinc).
138-703..................  3-NITRO (roxarsone)/COBAN (monensin)/ALBAC
                            (bacitracin zinc).
139-190..................  3-NITRO (roxarsone)/BIO-COX (salinomycin)/
                            BACIFERM (bacitracin zinc).
140-581..................  3-NITRO (roxarsone)/BIO-COX (salinomycin)/
                            LINCOMIX (lincomycin).
140-852..................  3-NITRO (roxarsone)/MONTEBAN/BMD (bacitracin
                            MD).
140-867..................  3-NITRO (roxarsone)/BIO-COX (salinomycin)/
                            AUREOMYCIN (chlortetracycline).
141-100..................  3-NITRO (roxarsone)/DECCOX (decoquinate)/BMD
                            (bacitracin MD).
141-112..................  3-NITRO (roxarsone)/MAXIBAN (narasin and
                            nicarbazin)/BMD (bacitracin MD).
141-121..................  3-NITRO (roxarsone)/BIO-COX (salinomycin)/BMD
                            (bacitracin MD).
141-131..................  3-NITRO (roxarsone)/ZOAMIX (zoalene)/BMD
                            (bacitracin MD).
141-135..................  3-NITRO (roxarsone)/BIO-COX (salinomycin).
141-138..................  3-NITRO (roxarsone)/COBAN (monensin)/BMD
                            (bacitracin MD).
141-139..................  3-NITRO (roxarsone)/COBAN (monensin).
141-142..................  3-NITRO (roxarsone)/AMPROL (amprolium)/BMD
                            (bacitracin MD).
141-155..................  3-NITRO (roxarsone)/ROBENZ (robenidine)/BMD
                            (bacitracin MD).
141-157..................  3-NITRO (roxarsone)/STENOROL (halofuginone).
141-223..................  3-NITRO (roxarsone)/CLINACOX (diclazuril).
141-293..................  3-NITRO (roxarsone)/AVATEC (lasalocid).
200-206..................  3-NITRO (roxarsone)/ALBAC (bacitracin zinc)/
                            DECCOX (decoquinate).
200-207..................  3-NITRO (roxarsone)/ALBAC (bacitracin zinc)/
                            COYDEN 25 (clopidol).
200-208..................  3-NITRO (roxarsone)/ALBAC (bacitracin zinc)/
                            AVATEC (lasalocid).
200-209..................  3-NITRO (roxarsone)/ALBAC (bacitracin zinc)/
                            SACOX (salinomycin).
200-214..................  3-NITRO (roxarsone)/ALBAC (bacitracin zinc)/
                            AMPROL HI-E (amprolium and ethopabate).
200-211..................  3-NITRO (roxarsone)/ALBAC (bacitracin zinc)/
                            COBAN (monensin).
200-215..................  3-NITRO (roxarsone)/ALBAC (bacitracin zinc)/
                            BIO-COX (salinomycin).
200-217..................  3-NITRO (roxarsone)/ALBAC (bacitracin zinc)/
                            AMPROL HI-E (amprolium and ethopabate).
200-259..................  3-NITRO (roxarsone)/SACOX (salinomycin)/
                            CHLORMAX (chlortetracycline).
200-260..................  3-NITRO (roxarsone)/BIO-COX (salinomycin)/
                            CHLORMAX (chlortetracycline).
038-879..................  CARB-O-SEP (carbarsone)/ZOAMIX (zoalene).
039-646..................  CARB-O-GAIN (carbarsone)/BMD (bacitracin MD).
136-484..................  CARB-O-SEP (carbarsone)/BACIFERM (bacitracin
                            zinc).
200-203..................  CARB-O-SEP (carbarsone)/ALBAC (bacitracin
                            zinc).
------------------------------------------------------------------------

     Huvepharma AD, 5th Floor, 3A Nikolay Haitov Str., 1113
Sofia, Bulgaria, has requested that FDA withdraw approval of the
following 16 NADAs and 8 ANADAs:

------------------------------------------------------------------------
        NADA/ANADA                  Ingredient new animal drugs
------------------------------------------------------------------------
013-461..................  3-NITRO (roxarsone)/AMPROL Plus (amprolium
                            and ethopabate).
040-264..................  3-NITRO (roxarsone)/COYDEN 25 (clopidol).
041-541..................  3-NITRO (roxarsone)/COYDEN 25 (clopidol)/BMD
                            (bacitracin MD).
044-016..................  Roxarsone + bacitracin Zinc/COYDEN 25
                            (clopidol).

049-179..................  Roxarsone/AMPROL HI-E (amprolium and
                            ethopabate).
049-180..................  Roxarsone/AMPROL HI-E (amprolium and
                            ethopabate)/BMD (bacitracin MD).
095-547..................  3-NITRO (roxarsone)/AMPROL HI-E (amprolium
                            and ethopabate)/FLAVOMYCIN (bambermycins).
095-548..................  3-NITRO (roxarsone)/AMPROL (amprolium)/
                            FLAVOMYCIN (bambermycins).
095-549..................  3-NITRO (roxarsone)/AMPROL (amprolium)/
                            FLAVOMYCIN (bambermycins).
098-341..................  3-NITRO (roxarsone)/COBAN (monensin)/
                            FLAVOMYCIN (bambermycins).
101-628..................  3-NITRO (roxarsone)/FLAVOMYCIN (bambermycins)/
                            zoalene.
140-533..................  3-NITRO (roxarsone)/STENOROL (halofuginone)/
                            BMD (bacitracin MD).
140-843..................  3-NITRO (roxarsone)/MONTEBAN (narasin)/
                            FLAVOMYCIN (bambermycins).
141-190..................  3-NITRO (roxarsone)/LINICOX (diclazuril)/BMD
                            (bacitracin MD).
200-080..................  3-NITRO (roxarsone)/SACOX (salinomycin)/
                            FLAVOMYCIN (bambermycins).
200-081..................  3-NITRO (roxarsone)/SACOX (salinomycin)/BMD
                            (bacitracin MD).
200-086..................  3-NITRO (roxarsone)/SACOX (salinomycin)/ALBAC
                            (bacitracin zinc).
200-090..................  3-NITRO (roxarsone)/SACOX (salinomycin)/
                            LINCOMIX (lincomycin).
200-091..................  3-NITRO (roxarsone)/SACOX (salinomycin)/
                            AUREOMYCIN (chlortetracycline).
200-094..................  3-NITRO (roxarsone)/SACOX (salinomycin)/
                            STAFAC (virginiamycin).
200-097..................  3-NITRO (roxarsone)/SACOX (salinomycin).
200-143..................  3-NITRO (roxarsone)/SACOX (salinomycin)/
                            BACIFERM (bacitracin zinc).
118-507..................  CARB-O-SEP (carbarsone)/AMPROL (amprolium).
130-661..................  CARB-O-SEP (carbarsone)/FLAVOMYCIN
                            (bambermycins).
------------------------------------------------------------------------

     Phibro Animal Health Corp., GlenPointe Centre East, 3d
floor, 300 Frank W. Burr Blvd., suite 21, Teaneck, NJ 07666 has
requested that FDA withdraw approval of the following seven NADAs and
two ANADAs:

------------------------------------------------------------------------
        NADA/ANADA                  Ingredient new animal drugs
------------------------------------------------------------------------
107-997..................  Roxarsone/NICARB (nicarbazin)/LINCOMIX
                            (lincomycin).
108-115..................  Roxarsone/NICARB (nicarbazin).
120-724..................  3-NITRO (roxarsone)/STAFAC (virginiamycin)/
                            COBAN (monensin).
138-953..................  3-NITRO (roxarsone)/STAFAC (virginiamycin)/
                            BIO-COX (salinomycin).
141-058..................  3-NITRO (roxarsone)/AVIAX (semduramycin)/BMD
                            (bacitracin MD).
141-066..................  3-NITRO (roxarsone)/AVIAX (semduramycin).
141-226..................  Roxarsone/AVIAX (semduramycin)/STAFAC
                            (virginiamycin).
200-170..................  3-NITRO (roxarsone)/NICARMIX 25 (nicarbazin)/
                            LINCOMIX (lincomycin).
200-172..................  3-NITRO (roxarsone)/NICARMIX 25 (nicarbazin).
------------------------------------------------------------------------

     Elanco Animal Health, A Division of Eli Lilly & Co., Lilly
Corporate Center, Indianapolis, IN 46285 has requested that FDA
withdraw approval of the following four NADAs:

------------------------------------------------------------------------
           NADA                     Ingredient new animal drugs
------------------------------------------------------------------------
041-500..................  3-NITRO (roxarsone)/COBAN (monensin).
049-464..................  Roxarsone/monensin/bacitracin.
140-445..................  Roxarsone/MONTEBAN (narasin).
141-113..................  3-NITRO (roxarsone)/MAXIBAN (narasin and
                            nicarbazin).
------------------------------------------------------------------------

     Cross Vetpharm Group Ltd., Broomhill Rd., Tallaght, Dublin
24, Ireland, has requested that FDA withdraw approval of the following
three NADAs:

------------------------------------------------------------------------
           NADA                     Ingredient new animal drugs
------------------------------------------------------------------------
038-241..................  PRO-GEN (arsanilic acid)/ERYTHRO
                            (erythromycin)/zoalene.
038-242..................  PRO-GEN (arsanilic acid)/ERYTHRO
                            (erythromycin)/amprolium + ethopabate.
038-624..................  PRO-GEN (arsanilic acid)/ERYTHRO
                            (erythromycin).
------------------------------------------------------------------------

     Pennfield Oil Co., 14040 Industrial Rd., Omaha, NE 68144
has requested that FDA withdraw approval of the following ANADA:

------------------------------------------------------------------------
           NADA                     Ingredient new animal drugs
------------------------------------------------------------------------
200-355..................  3-NITRO (roxarsone)/PENNCHLOR
                            (chlortetracycline)/BIO-COX (salinomycin).
------------------------------------------------------------------------

    Elsewhere in this issue of the Federal Register, FDA gave notice
that approval of these NADAs and ANADAs, and all supplements and
amendments thereto, is withdrawn, effective March 10, 2014. As provided
in the regulatory text of this document, the animal drug regulations
are amended to reflect these voluntary withdrawals of approval.
    In addition, FDA has noticed that certain sections in part 558
contain entries describing conditions of use for combination drug
medicated feeds for which no NADA is approved. These errors were
introduced by the Agency during the 1976 recodification of certain food
additive regulations (41 FR 10984, March 15, 1976). That rule did not
identify whether particular regulations were the subject of an approved
NADA and consequently resulted in codification of certain conditions of
use for which there is no approved NADA. At this time, the Agency is
amending the regulations to remove entries that describe conditions of
use for combination drug medicated feeds for which no NADA is approved.
This action is being taken to improve the accuracy of the regulations.
    This rule does not meet the definition of ``rule'' in 5 U.S.C.
804(3)(A) because it is a rule of ``particular applicability.''
Therefore, it is not subject to the congressional review requirements
in 5 U.S.C. 801-808.

List of Subjects

21 CFR Parts 556

    Animal drugs, Food.

21 CFR Parts 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 21 CFR part 556 continues to read as
follows:

    Authority: 21 U.S.C. 342, 360b, 371.

0
2. Revise Sec.  556.60 to read as follows:

Sec.  556.60  Arsenic.

    (a) [Reserved]
    (b) Tolerances. The tolerances for total residue of combined
arsenic (calculated as As) are:
    (1) Turkeys--(i) Muscle and eggs: 0.5 parts per million (ppm).
    (ii) Other edible tissues: 2 ppm.
    (2) [Reserved]
    (c) Related conditions of use. See Sec.  558.369 of this chapter.

PART 558--NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS

0
3. The authority citation for 21 CFR part 558 continues to read as
follows:

    Authority: 21 U.S.C. 360b, 371.

Sec.  558.4  [Amended]

0
4. In Sec.  558.4, in paragraph (d), in the ``Category II'' table:
0
a. Remove the entries for ``Arsanilate acid'', ``Carbarsone'', and
``Sulfaquinoxaline'';
0
b. Remove the row entries under ``Nitarsone'' for ``Sulfanitran'' and
``Roxarsone''.
0
c. Remove the four entries for ``Roxarsone'' and their respective
following row entries; and
0
d. In the fourth entry for ``Sulfamethazine,'' remove its three
following row entries for ``Aklomide'' and two following row entries
for ``Roxarsone''.

0
5. In Sec.  558.55, revise paragraphs (d)(1) through (3) and add
paragraph (d)(4) to read as follows:

Sec.  558.55  Amprolium.

* * * * *
    (d) * * *
    (1) Cattle. It is used as follows:

----------------------------------------------------------------------------------------------------------------
      Amprolium in grams per ton              Indications for use                Limitations            Sponsor
----------------------------------------------------------------------------------------------------------------
(i) 113.5 to 11, 350; to provide 5      Calves: As an aid in the        Top-dress on or mix in the        016592
 milligrams per kilogram of body         prevention of coccidiosis       daily ration. Feed for 21
 weight per day.                         caused by Eimeria bovis and     days when experience
                                         E. zuernii.                     indicates that coccidiosis
                                                                         is likely to be a hazard, as
                                                                         the sole source of
                                                                         amprolium. Withdraw 24 hours
                                                                         before slaughter. A
                                                                         withdrawal period has not
                                                                         been established for this
                                                                         product in preruminating
                                                                         calves. Do not use in calves
                                                                         to be processed for veal.
(ii) 113.5 to 11, 350; to provide 10    Calves: As an aid in the        Top-dress on or mix in the        016592
 milligrams per kilogram of body         treatment of coccidiosis        daily ration. Feed for 5
 weight per day.                         caused by Eimeria bovis and     days as the sole source of
                                         E. zuernii.                     amprolium. Withdraw 24 hours
                                                                         before slaughter. A
                                                                         withdrawal period has not
                                                                         been established for this
                                                                         product in preruminating
                                                                         calves. Do not use in calves
                                                                         to be processed for veal.
----------------------------------------------------------------------------------------------------------------

    (2) Chickens. It is used as follows:

----------------------------------------------------------------------------------------------------------------
                                   Combination in
   Amprolium in grams per ton       grams per ton      Indications for use          Limitations         Sponsor
----------------------------------------------------------------------------------------------------------------
(i) 36.3 to 113.5..............  ..................  Replacement chickens:    Feed continuously until     016592
                                                      For development of       onset of production as
                                                      active immunity to       follows:
                                                      coccidiosis.
----------------------------------------------------------------------------------------------------------------

----------------------------------------------------------------------------------------------------------------
                                                Up to 5 weeks of age  From 5 to 8 weeks of   Over 8 weeks of age
                                               ----------------------          age         ---------------------
              Growing conditions                                     ----------------------
                                                 Amprolium in grams    Amprolium in grams    Amprolium in grams
                                                       per ton               per ton               per ton
----------------------------------------------------------------------------------------------------------------
Severe exposure to coccidiosis................                 113.5            72.6-113.5            36.3-113.5
                                                           (0.0125%)      (0.008%-0.0125%)      (0.004%-0.0125%)
Moderate exposure to coccidiosis..............            72.6-113.5            54.5-113.5            36.3-113.5

                                                    (0.008%-0.0125%)      (0.006%-0.0125%)      (0.004%-0.0125%)
Slight exposure to coccidiosis................            36.3-113.5            36.3-113.5            36.3-113.5
                                                    (0.004%-0.0125%)      (0.004%-0.0125%)      (0.004%-0.0125%)
----------------------------------------------------------------------------------------------------------------

----------------------------------------------------------------------------------------------------------------
                                   Combination in
   Amprolium in grams per ton       grams per ton      Indications for use          Limitations         Sponsor
----------------------------------------------------------------------------------------------------------------
(ii) 36.3 to 113.5.............  Bacitracin          Replacement chickens:    Feed according to           054771
                                  methylene           For development of       subtable in item (i).
                                  disalicylate 4 to   active immunity to       Bacitracin methylene
                                  50.                 coccidiosis; and for     disalicylate as
                                                      increased rate of        provided by No. 054771
                                                      weight gain and          in Sec.   510.600(c)
                                                      improved feed            of this chapter.
                                                      efficiency.
(iii) 72.6 to 113.5............  ..................  Broiler chickens: For    Feed continuously as        016592
                                                      prevention of            the sole ration; as
                                                      coccidiosis caused by    sole source of
                                                      Eimeria tenella only.    amprolium.
(iv) 72.6 to 113.5.............  Bambermycins 1 to   Broiler chickens: For    Feed continuously as        016592
                                  2.                  prevention of            the sole ration; as
                                                      coccidiosis caused by    sole source of
                                                      Eimeria tenella only;    amprolium.
                                                      and for increased rate   Bambermycins as
                                                      of weight gain and       provided by No. 016592
                                                      improved feed            in Sec.   510.600(c)
                                                      efficiency.              of this chapter.
(v) 113.5......................  ..................  1. Laying chickens: For  Feed continuously as        016592
                                                      prevention of            the sole ration; as
                                                      coccidiosis.             the sole source of
                                                                               amprolium.
                                                     2. Laying chickens: For  Feed for 2 weeks.......
                                                      treatment of
                                                      coccidiosis in
                                                      moderate outbreaks.
(vi) 113.5 to 227..............  ..................  1. Replacement           Feed continuously from      016592
                                                      chickens: For            day-old until onset of
                                                      prevention of            production; as the
                                                      coccidiosis where        sole source of
                                                      immunity to              amprolium.
                                                      coccidiosis is not
                                                      desired.
                                                     2. Broiler chickens:     Feed continuously as
                                                      For prevention of        the sole ration; as
                                                      coccidiosis where        sole source of
                                                      immunity to              amprolium.
                                                      coccidiosis is not
                                                      desired.
(vii) 113.5 to 227.............  Bambermycins 1 to   Broiler chickens: For    Feed continuously as        016592
                                  2.                  prevention of            the sole ration; as
                                                      coccidiosis where        sole source of
                                                      immunity to              amprolium.
                                                      coccidiosis is not       Bambermycins as
                                                      desired; and for         provided by No. 016592
                                                      increased rate of        in Sec.   510.600(c)
                                                      weight gain and          of this chapter.
                                                      improved feed
                                                      efficiency.
(viii) 227.....................  ..................  Laying chickens: For     Feed for 2 weeks.......     016592
                                                      treatment of
                                                      coccidiosis in severe
                                                      outbreaks..
----------------------------------------------------------------------------------------------------------------

    (3) Turkeys. It is used as follows:

----------------------------------------------------------------------------------------------------------------
                                   Combination in
   Amprolium in grams per ton       grams per ton      Indications for use          Limitations         Sponsor
----------------------------------------------------------------------------------------------------------------
(i) 113.5......................  Bambermycins 1 to   Growing turkeys: For     Feed continuously as        016592
                                  4.                  prevention of            the sole source of
                                                      coccidiosis; and for     amprolium;
                                                      increased rate of        bambermycins as
                                                      weight gain and          provided by No. 016592
                                                      improved feed            in Sec.   510.600(c)
                                                      efficiency.              of this chapter.
(ii) 113.5 to 227..............  ..................  Turkeys: For prevention  Feed continuously as        016592
                                                      of coccidiosis.          the sole ration; as
                                                                               sole source of
                                                                               amprolium.
----------------------------------------------------------------------------------------------------------------

    (4) Pheasants. It is used as follows:

----------------------------------------------------------------------------------------------------------------
                                   Combination in
   Amprolium in grams per ton       grams per ton      Indications for use          Limitations         Sponsor
----------------------------------------------------------------------------------------------------------------
(i) 159........................  ..................  Growing pheasants: For   Feed continuously as        016592
                                                      the prevention of        sole ration. Use as
                                                      coccidiosis caused by    sole source of
                                                      Eimeria colchici, E.     amprolium.
                                                      duodenalis, and E.
                                                      phasiani.
(ii) [Reserved]
----------------------------------------------------------------------------------------------------------------

0
6. In Sec.  558.58, revise paragraph (e) to read as follows:

Sec.  558.58  Amprolium and ethopabate.

* * * * *
    (e) Conditions of use. It is used in chicken feed as follows:

----------------------------------------------------------------------------------------------------------------
  Amprolium and ethopabate in      Combination in
         grams per ton              grams per ton      Indications for use          Limitations         Sponsor
----------------------------------------------------------------------------------------------------------------
(1) Amprolium 113.5 and          ..................  Broiler chickens: As an  Feed continuously as        016592
 ethopabate 3.6.                                      aid in the prevention    sole ration; as sole
                                                      of coccidiosis.          source of amprolium.
                                                                               Not for laying
                                                                               chickens.
(2) Amprolium 113.5 and          Lincomycin 2 to 4.  Broiler chickens: As an  Feed continuously as        054771
 ethopabate 3.6.                                      aid in the prevention    sole ration; as sole
                                                      of coccidiosis; for      source of amprolium.
                                                      increased rate of        Not for laying
                                                      weight gain and          chickens.
                                                      improved feed           Lincomycin as provided
                                                      efficiency.              by No. 054771 in Sec.
                                                                                510.600(c) of this
                                                                               chapter.
(3) Amprolium 113.5 and          ..................  Broiler chickens and     Feed continuously as        016592
 ethopabate 36.3.                                     replacement chickens:    sole ration; as sole
                                                      where immunity to        source of amprolium.
                                                      coccidiosis is not       Not for chickens over
                                                      desired: As an aid in    16 weeks of age.
                                                      the prevention of
                                                      coccidiosis where
                                                      severe exposure to
                                                      coccidiosis from
                                                      Eimeria acervulina, E.
                                                      maxima, and E.
                                                      brunetti is likely to
                                                      occur.
(4) Amprolium 113.5 and          Bacitracin 4 to 50  1. Broiler chickens and  Feed as the sole ration     016592
 ethopabate 36.3.                                     replacement chickens:    from the time chickens
                                                      where immunity to        are placed on litter
                                                      coccidiosis is not       until past the time
                                                      desired; to aid in       when coccidiosis is
                                                      prevention of            ordinarily a hazard.
                                                      coccidiosis where        Not for chickens over
                                                      severe exposure to       16 weeks of age; do
                                                      coccidiosis from         not feed to laying
                                                      Eimeria acervulina, E.   chickens; as sole
                                                      maxima, and E.           source of amprolium;
                                                      brunetti is likely to    not for use as a
                                                      occur; for increased     treatment for
                                                      rate of weight gain in   outbreaks of
                                                      broiler chickens         coccidiosis.
                                                      raised in floor pens.    Bacitracin as
                                                                               bacitracin methylene
                                                                               disalicylate as
                                                                               provided by No. 054771
                                                                               in Sec.   510.600(c)
                                                                               of this chapter.
(5) Amprolium 113.5 and          Bacitracin 4 to 50  2. Broiler chickens: As  Feed as the sole ration     054771
 ethopabate 36.3.                                     an aid in prevention     from the time chickens
                                                      of coccidiosis where     are placed on litter
                                                      severe exposure to       until market weight.
                                                      coccidiosis from         Not for chickens over
                                                      Eimeria acervulina, E.   16 weeks of age; do
                                                      maxima, and E.           not feed to laying
                                                      brunetti is likely to    chickens; as sole
                                                      occur; for improved      source of amprolium;
                                                      feed efficiency.         not for use as a
                                                                               treatment for
                                                                               coccidiosis.
                                                                               Bacitracin zinc as
                                                                               provided by No. 054771
                                                                               in Sec.   510.600(c)
                                                                               of this chapter.
(6) Amprolium 113.5 and          Bambermycins 1 to   Broiler chickens: As an  Feed continuously as        016592
 ethopabate 3.6.                  3.                  aid in the prevention    the sole ration; as
                                                      of coccidiosis where     sole source of
                                                      severe exposure to       amprolium.
                                                      coccidiosis from        Bambermycins as
                                                      Eimeria acervulina, E.   provided by No. 016592
                                                      maxima, and E.           in Sec.   510.600(c)
                                                      brunetti is likely to    of this chapter.
                                                      occur; for increased
                                                      rate of weight gain,
                                                      improved feed
                                                      efficiency.
(7) Amprolium 113.5 and          Virginiamycin 15..  Broiler chickens; as an  Feed continuously as        066104
 ethopabate 36.3.                                     aid in the prevention    the sole ration; as
                                                      of coccidiosis where     sole source of
                                                      severe exposure to       amprolium. Do not feed
                                                      coccidiosis from         to laying chickens.
                                                      Eimeria acervulina, E.   Not for chickens over
                                                      maxima, and E.           16 weeks of age.
                                                      brunetti is likely to   Virginiamycin as
                                                      occur; for increased     provided by No. 066104
                                                      rate of weight gain      in Sec.   510.600(c)
                                                      and improved feed        of this chapter.
                                                      efficiency.
(8) Amprolium 113.5 and          Virginiamycin 5 to  Broiler chickens; as an  Feed continuously as        066104
 ethopabate 36.3.                 15.                 aid in the prevention    the sole ration; as
                                                      of coccidiosis where     sole source of
                                                      severe exposure to       amprolium. Do not feed
                                                      coccidiosis from         to laying chickens.
                                                      Eimeria acervulina, E.   Not for chickens over
                                                      maxima, and E.           16 weeks of age.
                                                      brunetti is likely to   Virginiamycin as
                                                      occur; for increased     provided by No. 066104
                                                      rate of weight gain.     in Sec.   510.600(c)
                                                                               of this chapter.
(9) Amprolium 227 and            ..................  For broiler chickens     Not for laying chickens     016592
 ethopabate 3.6.                                      and replacement
                                                      chickens where
                                                      immunity to
                                                      coccidiosis is not
                                                      desired; prevention of
                                                      coccidiosis.
(10) Amprolium 227 and           Chlortetracycline   For chickens where       Do not feed to chickens     054771
 ethopabate 3.6.                  100 to 200.         immunity to              producing eggs for
                                                      coccidiosis is not       human consumption.
                                                      desired; prevention of   Feed for 7 to 14 days.
                                                      coccidiosis; control
                                                      of infectious
                                                      synovitis caused by
                                                      Mycoplasma synoviae
                                                      susceptible to
                                                      chlortetracycline.
(11) Amprolium 227 and           Chlortetracycline   For chickens where       In low calcium feed         054771
 ethopabate 3.6.                  200 to 400.         immunity to              containing 0.8%
                                                      coccidiosis is not       dietary calcium and
                                                      desired; prevention of   1.5% sodium sulfate;
                                                      coccidiosis; control     feed continuously as
                                                      of chronic respiratory   sole ration for 7 to
                                                      disease (CRD) and air    14 days; do not feed
                                                      sac infection caused     to chickens producing
                                                      by M. gallisepticum      eggs for human
                                                      and E. coli              consumption.
                                                      susceptible to
                                                      chlortetracycline.
----------------------------------------------------------------------------------------------------------------

Sec.  558.62  [Removed]

0
7. Remove Sec.  558.62.

0
8. In Sec.  558.76, revise paragraph (d)(3) to read as follows:

Sec.  558.76  Bacitracin methylene disalicylate.

* * * * *
    (d) * * *
    (3) Bacitracin methylene disalicylate may also be used in
combination with:
    (i) Amprolium as in Sec.  558.55.
    (ii) Amprolium and ethopabate as in Sec.  558.58.
    (iii) Decoquinate as in Sec.  558.195.
    (iv) Diclazuril as in Sec.  558.198.
    (v) Fenbendazole as in Sec.  588.258.
    (vi) Halofuginone as in Sec.  558.265.
    (vii) Hygromycin B as in Sec.  588.274.
    (viii) Ivermectin as in Sec.  558.300.
    (ix) Lasalocid sodium as in Sec.  558.311.
    (x) Monensin as in Sec.  588.355.
    (xi) Narasin as in Sec.  558.363.
    (xii) Nicarbazin alone and with narasin as in Sec.  558.366.
    (xiii) Nitarsone as in Sec.  558.369.
    (xiv) Robenidine as in Sec.  558.515.
    (xv) Salinomycin as in Sec.  558.550.
    (xvi) Semduramicin as in Sec.  558.555.
    (xvii) Zoalene as in Sec.  558.680.

0
9. In Sec.  558.78, revise paragraph (d)(3) to read as follows:

Sec.  558.78  Bacitracin zinc.

* * * * *
    (d) * * *
    (3) Bacitracin zinc may also be used in combination with:
    (i) Amprolium and ethopabate as in Sec.  558.58.
    (ii) Clopidol as in Sec.  558.175.
    (iii) Decoquinate as in Sec.  558.195.
    (iv) Lasalocid as in Sec.  558.311.
    (v) Monensin as in Sec.  558.355.
    (vi) Naracin as in Sec.  558.363.
    (vii) Nitarsone as in Sec.  558.369.
    (viii) Robenidine as in Sec.  558.515.
    (ix) Salinomycin as in Sec.  558.550.
0
10. In Sec.  558.95, revise paragraph (d)(5) to read as follows:

Sec.  558.95  Bambermycins.

* * * * *
    (d) * * *
    (5) Bambermycins may also be used in combination with:
    (i) Amprolium as in Sec.  558.55.
    (ii) Amprolium and ethopabate as in Sec.  558.58.
    (iii) Clopidal as in Sec.  558.175.
    (iv) Diclazuril as in Sec.  558.198.
    (v) Halofuginone as in Sec.  558.265.
    (vi) Lasalocid as in Sec.  558.311.
    (vii) Monensin as in Sec.  558.355.
    (viii) Narasin alone or with nicarbazin as in Sec.  558.363.
    (ix) Nicarbazin as in Sec.  558.366.
    (x) Salinomycin as in Sec.  558.550.
    (xi) Zoalene as in Sec.  558.680.

Sec.  558.120  [Removed]

0
11. Remove Sec.  558.120.

0
12. In Sec.  558.128, revise paragraph (e)(7) to read as follows:

Sec.  558.128  Chlortetracycline.

* * * * *
    (e) * * *
    (7) Chlortetracycline may also be used in combination with:
    (i) Amprolium and ethopabate as in Sec.  558.58.
    (ii) Bacitracin methylene disalicylate as in Sec.  558.76.
    (iii) Clopidol as in Sec.  558.175.
    (iv) Decoquinate as in Sec.  558.195.
    (v) Hygromycin B as in Sec.  558.274.
    (vi) Laidlomycin as in Sec.  558.305.
    (vii) Lasalocid as in Sec.  558.311.
    (viii) Monensin as in Sec.  558.355.
    (ix) Robenidine as in Sec.  558.515.
    (x) Salinomycin as in Sec.  558.550.
    (xi) Tiamulin as in Sec.  558.600.

Sec.  558.175  [Amended]

0
13. In Sec.  558.175, remove paragraphs (d)(3) and (8); and redesignate
paragraphs (d)(4) through (7) as paragraphs (d)(3) through (6),
respectively, and paragraphs (d)(9) through (11) as paragraphs (d)(7)
through (9), respectively.

Sec.  558.195  [Amended]

0
14. In Sec.  558.195, remove paragraphs (e)(1)(iv) and (v) and
redesignate paragraphs (e)(1)(vi) through (ix) as paragraphs (e)(1)(iv)
through (vii), respectively.

Sec.  558.198  [Amended]

0
15. In Sec.  558.198, remove paragraphs (d)(1)(iii), (iv), and (vi) and
redesignate paragraphs (d)(1)(v), (vii), and (viii) as paragraphs
(d)(1)(iii), (iv), and (v), respectively.

0
16. In Sec.  558.248, remove paragraph (d)(3); and revise the section
heading to read as follows:

Sec.  558.248  Erythromycin.

* * * * *

0
17. In Sec.  558.265, remove and reserve paragraphs (d)(1)(v) and
(viii) and (d)(3)(ii) and revise the section heading to read as
follows:

Sec.  558.265  Halofuginone.

* * * * *

0
18. Revise Sec.  558.274 to read as follows:

Sec.  558.274  Hygromycin B.

    (a) Approvals. See sponsor numbers in Sec.  510.600(c) of this
chapter for Type A medicated articles or Type B medicated feeds as
follow:
    (1) No. 000986: 2.4 and 8 grams per pound (g/lb).
    (2) Nos. 012286 and 051311: 2.4 g/lb.
    (3) No. 017790: 0.6 g/lb.
    (4) No. 054771: 0.6 and 1.6 g/lb.
    (b) Related tolerances. See Sec.  556.330 of this chapter.
    (c) Conditions of use. It is used in feed as follows:
    (1) Chickens--

----------------------------------------------------------------------------------------------------------------
                                   Combination in
 Hygromycin B in grams per ton      grams per ton      Indications for use          Limitations         Sponsor
----------------------------------------------------------------------------------------------------------------
(i) 8 to 12....................  ..................  Chickens: For control    Withdraw 3 days before      000986
                                                      of infestation of        slaughter.                 012286
                                                      large roundworms                                    017790
                                                      (Ascaris galli), cecal                              054771
                                                      worms (Heterakis
                                                      gallinae), and
                                                      capillary worms
                                                      (Capillaria obsignata).
(ii) 8 to 12...................  Tylosin 4 to 50...  Chickens: For control    Withdraw 3 days before      000986
                                                      of infestations of       slaughter. Tylosin as
                                                      large roundworms         tylosin phosphate as
                                                      (Ascaris galli), cecal   provided by No. 000986
                                                      worms (Heterakis         in Sec.   510.600 of
                                                      gallinae), and           this chapter.
                                                      capillary worms
                                                      (Capillaria
                                                      obsignata); growth
                                                      promotion and feed
                                                      efficiency.
----------------------------------------------------------------------------------------------------------------

    (2) Swine--

----------------------------------------------------------------------------------------------------------------
                                   Combination in
 Hygromycin B in grams per ton      grams per ton      Indications for use          Limitations         Sponsor
----------------------------------------------------------------------------------------------------------------
(i) 12.........................  ..................  Swine: For control of    Withdraw 15 days before     000986
                                                      infestation of large     slaughter.                 012286
                                                      roundworms (Ascaris                                 017790
                                                      suis), nodular worms                                054771
                                                      (Oesophagostomum
                                                      dentatum), and
                                                      whipworms (Trichuris
                                                      suis).
(ii) 12........................  Tylosin 10 to 100.  Swine: For control of    Feed continuously as        000986
                                                      infestations of large    follows: Animal weight
                                                      roundworms (Ascaris      (lbs.):
                                                      suis), nodular worms     Up to 40 . . . 20 to
                                                      (Oesophagostomum         100 \1\.
                                                      dentatum), and           41 to 100 . . . 20 to
                                                      whipworms (Trichuris     40 \1\.
                                                      suis); growth            101 to market weight .
                                                      promotion and feed       . . 10 to 20 \1\.
                                                      efficiency.             Withdraw 15 days before
                                                                               slaughter. Tylosin as
                                                                               tylosin phosphate as
                                                                               provided by No. 000986
                                                                               in Sec.   510.600 of
                                                                               this chapter.
----------------------------------------------------------------------------------------------------------------
\1\ Amount of Tylosin (g/t).

0
19. In Sec.  558.311:
0
a. In paragraph (e)(1)(ii), remove the entries for:
0
i.Roxarsone 45.4 (0.005 pct);
0
ii. Roxarsone 45.4 plus bambermycins 1 (0.00011 pct);
0
iii. Roxarsone 45.4 plus lincomycin 2.0;
0
iv. Roxarsone 45.4 plus bacitracin 10 to 25;
0
v. Roxarsone 45.4 plus bacitracin 10 or 30; and
0
vi. Roxarsone 45.4 plus bacitracin methylene disalicylate 50'';
0
b. In paragraph (e)(1)(xv), remove the entry for ``Roxarsone 22.7 to
45.4''; and
0
c. Revise paragraph (e)(5).
    The revision reads as follows:

Sec.  558.311  Lasalocid.

* * * * *
    (e) * * *
    (5) Lasalocid may also be used in combination with:
    (i) Melengestrol acetate alone or in combination with tylosin as in
Sec.  558.342.
    (ii) [Reserved]

0
20. In Sec.  558.325, revise paragraph (d)(3) to read as follows:

Sec.  558.325  Lincomycin.

* * * * *
    (d) * * *
    (3) Lincomycin may also be used in combination with:
    (i) Amprolium and ethopabate as in Sec.  558.58.
    (ii) Clopidol as in Sec.  558.175.
    (iii) Decoquinate as in Sec.  558.195.
    (iv) Fenbendazole as in Sec.  588.258.
    (v) Halofuginone as in Sec.  558.265.
    (vi) Ivermectin as in Sec.  558.300.
    (vii) Lasalocid sodium as in Sec.  558.311.
    (viii) Monensin as in Sec.  588.355.
    (ix) Nicarbazin alone and with narasin as in Sec.  558.366.
    (x) Pyrantel as in Sec.  558.485.
    (xi) Robenidine as in Sec.  558.515.
    (xii) Salinomycin as in Sec.  558.550.
    (xiii) Zoalene as in Sec.  558.680.

0
21. In Sec.  558.340, revise the section heading to read as follows:

Sec.  558.340  Maduramicin.

* * * * *

Sec.  558.355  [Amended]

0
22. In Sec.  558.355:
0
a. Remove and reserve paragraphs (f)(1)(ii), (vii), (x), (xi), (xii),
(xv), (xvi), (xvii), (xviii), (xix), (xx), (xxiii), (xxvi), and
(xxvii);
0
b. Remove and reserve paragraphs (f)(4)(vi) and (vii); and
0
c. Remove the second instance of a paragraph designated (f)(4)(iv)
(following (f)(4)(vii).

Sec.  558.363  [Amended]

0
23. In Sec.  558.363:
0
a. Remove and reserve paragraphs (a)(2), (a)(5) and (a)(6);
0
b. Remove paragraphs (d)(1)(ii), (v), (vii), (viii), and (ix) and
(d)(3)(iii) and (iv); and
0
c. Redesignate paragraphs (d)(1)(iii) and (iv) as paragraphs (d)(1)(ii)
and (iii), paragraph (d)(1)(vi) as paragraph (d)(1)(iv), and paragraphs
(d)(1)(x) and (xi) as paragraphs (d)(1)(v) and (vi).

Sec.  558.366  [Amended]

0
24. In the table in Sec.  558.366(d):
0
a. In the ``Nicarbazin in grams per ton'' column, following the entry
for ``27 to 45'', remove the row entries for:
0
i. Narasin 27 to 45, bacitracin methylene disalicylate 50, and
roxarsone 22.7 to 45.4; and
0
ii. Narasin 27 to 45 and roxarsone 22.7 to 45.4;
0
b. In the ``Nicarbazin in grams per ton'' column, following the entry
for ``90.8 to 181.6 (0.01 to 0.02 pct)'', remove the row entry for
``Bacitracin methylene disalicylate 4 to 50 and roxarsone 22.7 to
45.4''; and
0
c. In the ``Nicarbazin in grams per ton'' column, following the entry
for ``113.5 (0.0125 pct)'', remove the row entries for:
0
i. Roxarsone 22.7 (0.0025); and
0
ii. Roxarsone 22.7 (0.0025) plus lincomycin 2 (0.0004).''

Sec.  558.460  [Amended]

0
25. In Sec.  558.460, remove and reserve paragraph (d)(2).

0
26. In Sec.  558.515, in paragraph (d), remove the entries for
``Bacitracin (as bacitracin methylene disalicylate) 50 and roxarsone
22.7 to 45.4'', ``Bacitracin (as bacitracin methylene disalicylate) 100
to 200 and roxarsone 22.7 to 45.4'', and ``Roxarsone 22.5 to 45.4
(0.005 percent)''; and revise the section heading to read as follows:

Sec.  558.515  Robenidine.

* * * * *

Sec.  558.530  [Removed]

0
27. Remove Sec.  558.530.

Sec.  558.550  [Amended]

0
28. In Sec.  558.550, remove and reserve paragraphs (d)(1)(ii), (iv),
(v), (viii), (ix), (xii), (xiv), (xv), (xvii), (xviii), (xix), and
(xxiv) and (d)(3)(iv), (vi), and (vii).

Sec.  558.555  [Amended]

0
29. In Sec.  558.555, remove paragraphs (d)(3), (d)(4), and (d)(8); and
redesignate paragraphs (d)(5), (d)(6), and (d)(7) as paragraphs (d)(3),
(d)(4), and (d)(5), respectively.

Sec.  558.575  [Amended]

0
30. In Sec.  558.575, remove and reserve paragraph (d)(1)(ii).

0
31. In Sec.  558.680, revise paragraph (d) to read as follows:

Sec.  558.680  Zoalene.

* * * * *
    (d) Conditions of use--(1) Chickens--

----------------------------------------------------------------------------------------------------------------
                                   Combination in
      Zoalene in grams/ton          grams per ton      Indications for use          Limitations         Sponsor
----------------------------------------------------------------------------------------------------------------
(i) 36.3 to 113.5..............  ..................  Replacement chickens:    Grower ration not to be     054771
                                                      For development of       fed to birds over 14
                                                      active immunity to       weeks of age; as
                                                      coccidiosis.             follows:
----------------------------------------------------------------------------------------------------------------

----------------------------------------------------------------------------------------------------------------
                                                                  Starter ration Grams   Grower ration Grams per
                      Growing conditions                                per ton                    ton
----------------------------------------------------------------------------------------------------------------
Severe exposure...............................................          113.5 (0.0125%)               75.4-113.5
                                                                                (0.0083%-0.0125%)
Light to moderate exposure....................................               75.4-113.5                36.3-75.4
                                                                      (0.0083%-0.0125%)         (0.004%-0.0083%)
----------------------------------------------------------------------------------------------------------------

----------------------------------------------------------------------------------------------------------------
                                   Combination in
      Zoalene in grams/ton          grams per ton      Indications for use          Limitations         Sponsor
----------------------------------------------------------------------------------------------------------------
(ii) 36.3-113.5................  Bacitracin          Replacement chickens:    Feed continuously as        054771
                                  methylene           For development of       sole ration as in
                                  disalicylate 4 to   active immunity to       subtable in item (i).
                                  50.                 coccidiosis; and for     Grower ration not to
                                                      increased rate of        be fed to birds over
                                                      weight gain and          14 weeks of age.
                                                      improved feed            Bacitracin methylene
                                                      efficiency.              disalicylate as
                                                                               provided by No. 054771
                                                                               in Sec.   510.600(c)
                                                                               of this chapter.
(iii) 36.3-113.5...............  Bacitracin          Replacement chickens:    Feed continuously as        054771
                                  methylene           For development of       sole ration as in
                                  disalicylate 50.    active immunity to       subtable in item (i).
                                                      coccidiosis; and as an   Grower ration not to
                                                      aid in the prevention    be fed to birds over
                                                      of necrotic enteritis    14 weeks of age.
                                                      caused or complicated    Bacitracin methylene
                                                      by Clostridium spp. or   disalicylate as
                                                      other organisms          provided by No. 054771
                                                      susceptible to           in Sec.   510.600(c)
                                                      bacitracin.              of this chapter.
(iv) 36.3-113.5................  Bacitracin          Replacement chickens:    Feed continuously as        054771
                                  methylene           For development of       sole ration as in
                                  disalicylate 100    active immunity to       subtable in item (i).
                                  to 200.             coccidiosis; and as an   To control necrotic
                                                      aid in the control of    enteritis, start
                                                      necrotic enteritis       medication at first
                                                      caused or complicated    clinical signs of
                                                      by Clostridium spp. or   disease; vary
                                                      other organisms          bacitracin dosage
                                                      susceptible to           based on the severity
                                                      bacitracin.              of infection;
                                                                               administer
                                                                               continuously for 5 to
                                                                               7 days or as long as
                                                                               clinical signs
                                                                               persist, then reduce
                                                                               bacitracin to
                                                                               prevention level (50 g/
                                                                               ton). Bacitracin
                                                                               methylene disalicylate
                                                                               as provided by No.
                                                                               054771 in Sec.
                                                                               510.600(c) of this
                                                                               chapter.
(v) 113.5......................  ..................  Broiler chickens: For    Feed continuously as        054771
                                                      prevention and control   sole ration.
                                                      of coccidiosis.
(vi) 113.5.....................  Bacitracin          Broiler chickens: As an  Feed continuously as        054771
                                  methylene           aid in the prevention    sole ration.
                                  disalicylate 4 to   and control of           Bacitracin methylene
                                  50.                 coccidiosis; and for     disalicylate as
                                                      increased rate of        provided by No. 054771
                                                      weight gain and          in Sec.   510.600(c)
                                                      improved feed            of this chapter.
                                                      efficiency.
(vii) 113.5....................  Bacitracin          Broiler chickens: For    Feed continuously as        054771
                                  methylene           prevention and control   sole ration.
                                  disalicylate 50.    of coccidiosis; and as   Bacitracin methylene
                                                      an aid in the            disalicylate as
                                                      prevention of necrotic   provided by No. 054771
                                                      enteritis caused or      in Sec.   510.600(c)
                                                      complicated by           of this chapter.
                                                      Clostridium spp. or
                                                      other organisms
                                                      susceptible to
                                                      bacitracin.
(viii) 113.5...................  Bacitracin          Broiler chickens: For    Feed continuously as        054771
                                  methylene           prevention and control   sole ration. To
                                  disalicylate 100    of coccidiosis; and as   control necrotic
                                  to 200.             an aid in the control    enteritis, start
                                                      of necrotic enteritis    medication at first
                                                      caused or complicated    clinical signs of
                                                      by Clostridium spp. or   disease; vary
                                                      other organisms          bacitracin dosage
                                                      susceptible to           based on the severity
                                                      bacitracin.              of infection;
                                                                               administer
                                                                               continuously for 5 to
                                                                               7 days or as long as
                                                                               clinical signs
                                                                               persist, then reduce
                                                                               bacitracin to
                                                                               prevention level (50 g/
                                                                               ton).
                                                                              Bacitracin methylene
                                                                               disalicylate as
                                                                               provided by No. 054771
                                                                               in Sec.   510.600(c)
                                                                               of this chapter.
(ix) 113.5.....................  Bambermycins 1....  Broiler chickens: As an  Feed continuously as        016592
                                                      aid in the prevention    sole ration. Do not
                                                      and control of           feed to chickens over
                                                      coccidiosis; and for     14 weeks of age.
                                                      increased rate of        Bambermycins as
                                                      weight gain and          provided by No. 016592
                                                      improved feed            in Sec.   510.600(c)
                                                      efficiency.              of this chapter.
(x) 113.5......................  Lincomycin 2......  Broiler chickens: As an  Feed continuously as        054771
                                                      aid in the prevention    sole ration. Do not
                                                      and control of           feed to laying
                                                      coccidiosis; and for     chickens. As
                                                      increased rate of        lincomycin
                                                      weight gain and          hydrochloride
                                                      improved feed            monohydrate provided
                                                      efficiency.              by No. 054771 in Sec.
                                                                                510.600(c) of this
                                                                               chapter.
----------------------------------------------------------------------------------------------------------------

    (2) Turkeys--

----------------------------------------------------------------------------------------------------------------
                                   Combination in
      Zoalene in grams/ton          grams per ton      Indications for use          Limitations         Sponsor
----------------------------------------------------------------------------------------------------------------
(i) 113.5 to 170.3.............  ..................  Growing turkeys: For     Feed continuously as        054771
                                                      prevention and control   sole ration. For
                                                      of coccidiosis.          turkeys grown for meat
                                                                               purposes only. Do not
                                                                               feed to laying birds.
(ii) 113.5 to 170.3............  Bacitracin          Growing turkeys: For     Feed continuously as        054771
                                  methylene           prevention and control   sole ration until 14
                                  disalicylate 4 to   of coccidiosis; and      to 16 weeks of age.
                                  50.                 for increased rate of    For turkeys grown for
                                                      weight gain and          meat purposes only. Do
                                                      improved feed            not feed to laying
                                                      efficiency.              birds.
----------------------------------------------------------------------------------------------------------------

    Dated: February 3, 2014.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. 2014-02617 Filed 2-26-14; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register Volume 80, Number 142 (Friday, July 24, 2015)]
[Rules and Regulations]
[Pages 43956-43960]
[FR Doc No: 2015-18103]

=======================================================================
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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R05-OAR-2015-0407; FRL-9930-81-Region 5]

Air Plan Approval; MI, Belding; 2008 Lead Clean Data
Determination

AGENCY: Environmental Protection Agency (EPA).

ACTION: Direct final rule.

-----------------------------------------------------------------------

SUMMARY: On May 13, 2015, the Michigan Department of Environmental
Quality (MDEQ) submitted a request to the Environmental Protection
Agency (EPA) to make a determination under the Clean Air Act (CAA) that
the Belding, MI nonattainment area has attained the 2008 lead (Pb)
national

ambient air quality standard (NAAQS or standard). In this action, EPA
is determining that the Belding, MI nonattainment area (hereafter also
referred to as the ``Belding area'' or ``area'') has attained the 2008
Pb NAAQS. This clean data determination is based upon complete,
quality-assured and certified ambient air monitoring data for the 2012-
2014 period showing that the area has monitored attainment of the 2008
Pb NAAQS. Additionally, as a result of this determination, EPA is
suspending the requirements for the area to submit an attainment
demonstration, together with reasonably available control measures
(RACM), a reasonable further progress (RFP) plan, contingency measures
for failure to meet the RFP plan, and the attainment deadline for as
long as the area continues to attain the 2008 Pb NAAQS.

DATES: This direct final rule will be effective September 22, 2015,
unless EPA receives adverse comments by August 24, 2015. If adverse
comments are received, EPA will publish a timely withdrawal of the
direct final rule in the Federal Register informing the public that the
rule will not take effect.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-R05-
OAR-2015-0407, by one of the following methods:
    1. www.regulations.gov: Follow the on-line instructions for
submitting comments.
    2. Email<EMAIL_ADDRESS>    3. Fax:<PHONE_NUMBER>.
    4. Mail: Douglas Aburano, Chief, Attainment Planning and
Maintenance Section, Air Programs Branch (AR-18J), U.S. Environmental
Protection Agency, 77 West Jackson Boulevard, Chicago, Illinois 60604.
    5. Hand Delivery: Douglas Aburano, Chief, Attainment Planning and
Maintenance Section, Air Programs Branch (AR-18J), U.S. Environmental
Protection Agency, 77 West Jackson Boulevard, Chicago, Illinois 60604.
Such deliveries are only accepted during the Regional Office normal
hours of operation, and special arrangements should be made for
deliveries of boxed information. The Regional Office official hours of
business are Monday through Friday, 8:30 a.m. to 4:30 p.m., excluding
Federal holidays.
    Instructions: Direct your comments to Docket ID No. EPA-R05-OAR-
2015-0407. EPA's policy is that all comments received will be included
in the public docket without change and may be made available online at
www.regulations.gov, including any personal information provided,
unless the comment includes information claimed to be Confidential
Business Information (CBI) or other information whose disclosure is
restricted by statute. Do not submit information that you consider to
be CBI or otherwise protected through www.regulations.gov or email. The
www.regulations.gov Web site is an ``anonymous access'' system, which
means EPA will not know your identity or contact information unless you
provide it in the body of your comment. If you send an email comment
directly to EPA without going through www.regulations.gov your email
address will be automatically captured and included as part of the
comment that is placed in the public docket and made available on the
Internet. If you submit an electronic comment, EPA recommends that you
include your name and other contact information in the body of your
comment and with any disk or CD-ROM you submit. If EPA cannot read your
comment due to technical difficulties and cannot contact you for
clarification, EPA may not be able to consider your comment. Electronic
files should avoid the use of special characters, any form of
encryption, and be free of any defects or viruses.
    Docket: All documents in the docket are listed in the
www.regulations.gov index. Although listed in the index, some
information is not publicly available, e.g., CBI or other information
whose disclosure is restricted by statute. Certain other material, such
as copyrighted material, will be publicly available only in hard copy.
Publicly available docket materials are available either electronically
in www.regulations.gov or in hard copy at the Environmental Protection
Agency, Region 5, Air and Radiation Division, 77 West Jackson
Boulevard, Chicago, Illinois 60604. This facility is open from 8:30
a.m. to 4:30 p.m., Monday through Friday, excluding Federal holidays.
We recommend that you telephone Sarah Arra, Environmental Scientist, at
(312) 886-9401 before visiting the Region 5 office.

FOR FURTHER INFORMATION CONTACT: Sarah Arra, Environmental Scientist,
Attainment Planning and Maintenance Section, Air Programs Branch (AR-
18J), Environmental Protection Agency, Region 5, 77 West Jackson
Boulevard, Chicago, Illinois 60604,<PHONE_NUMBER><EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Throughout this document whenever ``we,''
``us,'' or ``our'' is used, we mean EPA. This supplementary information
section is arranged as follows:

I. What action is EPA taking?
II. What is the background for this action?
III. Application of EPA's Clean Data Policy to the 2008 Pb NAAQS
IV. Does the Belding area meet the 2008 Pb NAAQS?
V. What is the effect of this action?
VI. Statutory and Executive Order Reviews

I. What action is EPA taking?

    EPA is taking final action to determine that the Belding area has
attained the 2008 Pb NAAQS. This is based upon complete, quality-
assured and certified ambient air monitoring data for the 2012-2014
monitoring period showing that the area has monitored attainment of the
2008 Pb NAAQS.
    Further, with this clean data determination, the requirements for
the Belding area to submit an attainment demonstration together with
RACM, a RFP plan, and contingency measures for failure to meet the RFP
plan and attainment deadlines are suspended for as long as the area
continues to attain the 2008 Pb NAAQS. As discussed below, this action
is consistent with EPA's regulations and with its longstanding
interpretation of subpart 1 of part D of the CAA.
    If the Belding area violates the 2008 Pb NAAQS after this action,
the basis for the suspension of these attainment planning requirements
would no longer exist for that area, and the area would thereafter have
to address applicable requirements.

II. What is the background for this action?

    On November 12, 2008 (73 FR 66964), EPA established a 2008 primary
and secondary Pb NAAQS at 0.15 micrograms per cubic meter ([mu]g/m\3\)
based on a maximum arithmetic three-month mean concentration for a
three-year period. See 40 CFR 50.16. This is the ``2008 Pb NAAQS.'' On
November 22, 2010 (75 FR 71033), EPA published its initial air quality
designations for the 2008 Pb NAAQS based upon air quality monitoring
data for calendar years 2007-2009. On November 22, 2011 (76 FR 72097),
EPA published a second and final round of designations for the 2008 Pb
NAAQS based upon air quality monitoring data for calendar years 2008-
2010. As part of the second round, the Belding area was designated
nonattainment for the 2008 Pb NAAQS.
    On May 13, 2015, MDEQ submitted a request to EPA to make a
determination that the Belding area has attained the 2008 Pb NAAQS
based on complete, quality-assured, quality-controlled monitoring data
from 2012 through 2014. For the reasons set forth in this document, EPA
finds the request approvable.

III. Application of EPA's Clean Data Policy to the 2008 Pb NAAQS

    Following enactment of the CAA Amendments of 1990, EPA promulgated
its interpretation of the requirements for implementing the NAAQS in
the General Preamble for the Implementation of Title I of the CAA
Amendments of 1990 (General Preamble) 57 FR 13498, 13564 (April 16,
1992). In 1995, based on the interpretation of CAA sections 171 and
172, and section 182 in the General Preamble, EPA set forth what has
become known as its ``Clean Data Policy'' for the 1-hour ozone NAAQS.
See Memorandum from John S. Seitz, Director, Office of Air Quality
Planning and Standards, ``RFP, Attainment Demonstration, and Related
Requirements for Ozone Nonattainment areas Meeting the Ozone National
Ambient Air Quality Standard'' (May 10, 1995). In 2004, EPA indicated
its intention to extend the Clean Data Policy to the fine particulates
(PM2.5) NAAQS. See Memorandum from Steve Page, Director, EPA
Office of Air Quality Planning and Standards, ``Clean Data Policy for
the Fine Particle National Ambient Air Quality Standards'' (December
14, 2004). This policy was extended to Pb in 2012 (see 77 FR 35653).
    Since 1995, EPA has applied its interpretation under the Clean Data
Policy in many rulemakings, suspending certain attainment-related
planning requirements for individual areas, based on a clean data
determination. For a full discussion on EPA's application of this
policy, see section III of the Bristol, Tennessee Determination of
Attaining Data for the 2008 Pb Standards (77 FR 35653).

IV. Does the Belding area meet the 2008 Pb NAAQS?

A. Criteria

    This rulemaking assesses whether the Belding area has attained the
2008 Pb NAAQS, based on the most recent three years of quality-assured
data. The Belding area is comprised of a partial county area in Ionia
County \1\ and surrounds the Mueller Industries facility.
---------------------------------------------------------------------------

    \1\ The specific area is bounded by the following coordinates:
Southeast corner by latitude 43.0956705 N and longitude 85.2130771
W; southwest corner (intersection of S. Broas St. and W. Washington
St.) by latitude 43.0960358 N and longitude 85.2324027 W; northeast
corner by latitude 43.1074942 N and longitude 85.2132313 W; western
boundary 1 (intersection of W. Ellis St. and the vertical extension
of S. Broas St.) by latitude 43.1033277 N and longitude 85.2322553
W; western boundary 2 (intersection of W. Ellis St. and N. Bridge
St.) by latitude 43.1033911 N and longitude 85.2278464 W; western
boundary 3 (intersection of N. Bridge St. and Earle St.) by latitude
43.1074479 N and longitude 85.2279722 W.
---------------------------------------------------------------------------

    Under EPA regulations at 40 CFR 50.16, the 2008 primary and
secondary Pb standards are met when the maximum arithmetic three-month
mean concentration for a three-year period, as determined in accordance
with 40 CFR part 50, appendix R, is less than or equal to 0.15
[micro]g/m\3\ at all relevant monitoring sites in the subject area.
    EPA has reviewed the ambient air monitoring data for the Belding
area in accordance with the provisions of 40 CFR part 50, appendix R.
All data considered are complete, quality-assured, certified, and
recorded in EPA's Air Quality System database. This review addresses
air quality data collected in the 2012-2014 period which are the most
recent quality-assured data available.

B. Belding Area Air Quality

    The Belding area has two monitoring sites that are Federal
reference method source-oriented monitors which meet the quality
assurance requirements of 40 CFR 58, appendix A.\2\ After the Mueller
Industries facility: Restricted Pb emissions on its chip driers and
induction furnaces, implemented a preventative maintenance plan,
properly operated controls, increased stack height of the chip driers,
and increased monitoring, testing, and record keeping, as required
through state rules by October of 2013, the monitored Pb values were
well below the standard.
---------------------------------------------------------------------------

    \2\ During a routine audit, the monitor at site 26-067-0002 was
discovered to be 0.13 meters below the recommended height. However,
EPA determined that this would have minimal effect on the data and,
if any, would incorrectly measure concentrations as too high, rather
than too low. Therefore, the data were determined valid. The problem
was fixed on October 9, 2014 (see Belding Reed Memorandum in the
docket).
---------------------------------------------------------------------------

    Table 1 shows the 2012-2014 three-month rolling averages for
Belding Area monitor 26-067-0002 in [micro]g/m\3\.

----------------------------------------------------------------------------------------------------------------
               Location                      3-month period            2012            2013            2014
----------------------------------------------------------------------------------------------------------------
545 Reed St...........................  Nov-Jan \3\.............            0.03            0.02            0.02
                                        Dec-Feb.................            0.04            0.01            0.02
                                        Jan-Mar.................            0.05            0.01            0.02
                                        Feb-Apr.................            0.04            0.01            0.01
                                        Mar-May.................            0.04            0.03            0.02
                                        Apr-Jun.................            0.04            0.03            0.02
                                        May-July................            0.04            0.04            0.02
                                        Jun-Aug.................            0.04            0.05            0.01
                                        July-Sept...............            0.05            0.05            0.04
                                        Aug-Oct.................            0.04            0.06            0.04
                                        Sept-Nov................            0.03            0.04            0.04
                                        Oct-Dec.................            0.02            0.04            0.02
----------------------------------------------------------------------------------------------------------------

    Table 2 shows the 2012-2014 three-month rolling averages for
Belding Area monitor 26-067-0003 in [micro]g/m\3\.
---------------------------------------------------------------------------

    \3\ When calculating a three-month rolling average, the first
two data points, November through January for 2012 and December
through February of 2012, would additionally use data from November
and December of 2011.

----------------------------------------------------------------------------------------------------------------
               Location                      3-month period            2012            2013            2014
----------------------------------------------------------------------------------------------------------------
509 Merrick St........................  Nov-Jan \4\.............            0.02            0.02            0.05
                                        Dec-Feb.................            0.02            0.03            0.03
                                        Jan-Mar.................            0.03            0.03            0.02
                                        Feb-Apr.................            0.04            0.03            0.04

                                        Mar-May.................            0.05            0.03            0.04
                                        Apr-Jun.................            0.06            0.03            0.04
                                        May-July................            0.05            0.04            0.03
                                        Jun-Aug.................            0.05            0.04            0.03
                                        July-Sept...............            0.04            0.04            0.03
                                        Aug-Oct.................            0.03            0.03            0.03
                                        Sept-Nov................            0.02            0.04            0.03
                                        Oct-Dec.................            0.02            0.05            0.04
----------------------------------------------------------------------------------------------------------------

    The data shown in Tables 1 and 2 are complete, quality-assured, and
certified and show 0.06 [micro]g/m\3\ as the highest three-month
rolling average.
---------------------------------------------------------------------------

    \4\ The 2012 data set includes data from November and December
of 2011.
---------------------------------------------------------------------------

    The Mueller Industries facility's National Emissions Inventory
emissions in 2011 were 0.70 tons per year. With the combination of
restricted Pb emissions, preventative maintenance plan, properly
operating controls, increased stacks, and increased monitoring,
testing, and recordkeeping at the facility, the area is now monitoring
less than half of the standard.
    EPA's review of these data indicates that the Belding area has
attained and continues to attain the 2008 Pb NAAQS, with a design value
of 0.06 [micro]g/m\3\ for the period of 2012-2014.

V. What is the effect of this action?

    Based on complete, quality-assured and certified data for 2012-
2014, EPA is determining that the Belding area has attained the 2008 Pb
NAAQS. The requirements for MDEQ to submit an attainment demonstration
and associated RACM, a RFP plan, contingency measures, and any other
planning State Implementation Plans related to attainment of the 2008
Pb NAAQS for the Belding area is suspended for as long as the area
continues to attain the 2008 Pb NAAQS. This EPA rulemaking is
consistent and in keeping with its long-held interpretation of CAA
requirements, as well as with EPA's regulations for similar
determinations for ozone (see 40 CFR 51.918) and PM2.5 (see
40 CFR 51.1004(c)).
    This action does not constitute a redesignation of the area to
attainment of the 2008 Pb NAAQS under section 107(d)(3) of the CAA.
This action does not involve approving a maintenance plan for the area
as required under section 175A of the CAA, nor does it find that the
area has met all other requirements for redesignation. The Belding area
remains designated nonattainment for the 2008 Pb NAAQS until such time
as EPA determines that the area meets the CAA requirements for
redesignation to attainment and takes action to redesignate the area.
    We are publishing this action without prior proposal because we
view this as a noncontroversial amendment and anticipate no adverse
comments. However, in the proposed rules section of this Federal
Register publication, we are publishing a separate document that will
serve as the proposal to approve the state plan if relevant adverse
written comments are filed. This rule will be effective September 22,
2015 without further notice unless we receive relevant adverse written
comments by August 24, 2015. If we receive such comments, we will
withdraw this action before the effective date by publishing a
subsequent document that will withdraw the final action. Public
comments received will then be addressed in a subsequent final rule
based on the proposed action. EPA will not institute a second comment
period. Any parties interested in commenting on this action should do
so at this time. Please note that if EPA receives adverse comment on an
amendment, paragraph, or section of this rule and if that provision may
be severed from the remainder of the rule, EPA may adopt as final those
provisions of the rule that are not the subject of an adverse comment.
If we do not receive any comments, this action will be effective
September 22, 2015.

VI. Statutory and Executive Order Reviews

    This action makes a clean data determination for the Belding area
for the 2008 Pb NAAQS based on air quality data and results in the
suspension of certain Federal requirements and does not impose any
additional requirements. For that reason, this action:
     Is not a ``significant regulatory action'' subject to
review by the Office of Management and Budget under Executive Orders
12866 (58 FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21,
2011);
     Does not impose an information collection burden under the
provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);
     Is certified as not having a significant economic impact
on a substantial number of small entities under the Regulatory
Flexibility Act (5 U.S.C. 601 et seq.);
     Does not contain any unfunded mandate or significantly or
uniquely affect small governments, as described in the Unfunded
Mandates Reform Act of 1995 (Pub. L. 104-4);
     Does not have Federalism implications as specified in
Executive Order 13132 (64 FR 43255, August 10, 1999);
     Is not an economically significant regulatory action based
on health or safety risks subject to Executive Order 13045 (62 FR
19885, April 23, 1997);
     Is not a significant regulatory action subject to
Executive Order 13211 (66 FR 28355, May 22, 2001);
     Is not subject to requirements of Section 12(d) of the
National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272
note) because application of those requirements would be inconsistent
with the CAA; and
     Does not provide EPA with the discretionary authority to
address, as appropriate, disproportionate human health or environmental
effects, using practicable and legally permissible methods, under
Executive Order 12898 (59 FR 7629, February 16, 1994).
    In addition, the clean data determination is not approved to apply
on any Indian reservation land or in any other area where EPA or an
Indian tribe has demonstrated that a tribe has jurisdiction. In those
areas of Indian country, the rule does not have tribal implications and
will not impose substantial direct costs on tribal governments or
preempt tribal law as specified by Executive Order 13175 (65 FR 67249,
November 9, 2000).
    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and to the Comptroller General

of the United States. EPA will submit a report containing this action
and other required information to the U.S. Senate, the U.S. House of
Representatives, and the Comptroller General of the United States prior
to publication of the rule in the Federal Register. A major rule cannot
take effect until 60 days after it is published in the Federal
Register. This action is not a ``major rule'' as defined by 5 U.S.C.
804(2).
    Under section 307(b)(1) of the CAA, petitions for judicial review
of this action must be filed in the United States Court of Appeals for
the appropriate circuit by September 22, 2015. Filing a petition for
reconsideration by the Administrator of this final rule does not affect
the finality of this action for the purposes of judicial review nor
does it extend the time within which a petition for judicial review may
be filed, and shall not postpone the effectiveness of such rule or
action. Parties with objections to this direct final rule are
encouraged to file a comment in response to the parallel notice of
proposed rulemaking for this action published in the proposed rules
section of this Federal Register, rather than file an immediate
petition for judicial review of this direct final rule, so that EPA can
withdraw this direct final rule and address the comment in the proposed
rulemaking. This action may not be challenged later in proceedings to
enforce its requirements. (See section 307(b)(2)).

List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Incorporation by
reference, Intergovernmental relations, Lead, Reporting and
recordkeeping requirements.

    Dated: July 14, 2015.
Susan Hedman,
Regional Administrator, Region 5.

    40 CFR part 52 is amended as follows:

PART 52--APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS

0
1. The authority citation for part 52 continues to read as follows:

    Authority:  42 U.S.C. 7401 et seq.

0
2. Add Sec.  52.1188 to read as follows:

Sec.  52.1188  Control strategy: Lead (Pb).

    (a) Based upon EPA's review of the air quality data for the three-
year period 2012 to 2014, EPA determined that the Belding, MI Pb
nonattainment area has attained the 2008 Pb National Ambient Air
Quality Standard (NAAQS). This clean data determination suspends the
requirements for this area to submit an attainment demonstration,
associated reasonably available control measures, a reasonable further
progress plan, contingency measures, and other planning SIPs related to
attainment of the standard as long as this area continues to meet the
2008 Pb NAAQS.
    (b) [Reserved]

[FR Doc. 2015-18103 Filed 7-23-15; 8:45 am]
 BILLING CODE 6560-50-P