[Federal Register Volume 66, Number 227 (Monday, November 26, 2001)]
[Rules and Regulations]
[Pages 58935-58938]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-29352]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 558


New Animal Drugs for Use in Animal Feeds; Fenbendazole

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule; correction; technical amendment.

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SUMMARY: The Food and Drug Administration (FDA) is amending the animal 
drug regulations to restore indications for fenbendazole medicated 
feeds for cattle that have been inadvertently deleted from the 
regulations. Changes to a table format are also being made. This action 
is being taken to correct these errors and to improve the accuracy of 
the regulations.

DATES: This rule is effective November 26, 2001.

FOR FURTHER INFORMATION CONTACT: George K. Haibel, Center for 
Veterinary Medicine (HFV-6), Food and Drug Administration, 7519 
Standish Pl., Rockville, MD 20855, 301-827-4567, e-mail: 
[email protected].

SUPPLEMENTARY INFORMATION: FDA has discovered that an error has become 
incorporated into the agency's regulation for part 558 (21 CFR part 
558). A portion of the list of indications for fenbendazole medicated 
feeds for cattle was inadvertently deleted as a publication error 
beginning with the April 1, 1996, edition of the CFR. At this time, the 
regulations are being amended in Sec. 558.258 to correct this error, to 
format some portions of this section as a table, and to restructure 
other portions to more closely resemble similar regulations for free-
choice medicated feeds for cattle. Indications for the control of 
certain swine parasites, inadvertently removed in a previous revision 
of the regulations in the Federal Register of November 20, 1990 (55 FR 
48230), are also being added. The entire text of Sec. 558.258 is being 
provided for the convenience of the reader.
    Publication of this document constitutes final action on these 
changes under the Administrative Procedure Act (5 U.S.C. 553). Notice 
and public procedure are unnecessary because FDA is merely correcting 
nonsubstantive errors.
    This rule does not meet the definition of ``rule'' in 5 U.S.C. 
804(3)(A) because it is a rule of ``particular applicability.'' 
Therefore, it is not subject to the congressional review requirements 
in 5 U.S.C. 801-808.

List of Subjects in 21 CFR Part 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 part 558 is 
amended as follows:

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

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

    Authority: 21 U.S.C. 360b, 371.
    2. Section 558.258 is revised to read as follows:


Sec. 558.258  Fenbendazole.

    (a) Specifications. Type A medicated articles: 4 percent (18.1 
grams per pound (g/lb)), 8 percent (36.2 g/lb), and 20 percent (90.7 g/
lb) fenbendazole.
    (b) Approvals. See No. 057926 in Sec. 510.600(c) of this chapter.
    (c) Related tolerances. See Sec. 556.275 of this chapter.
    (d) Special considerations. See Sec. 500.25 of this chapter.
    (e) Conditions of use--(1) Turkeys.

----------------------------------------------------------------------------------------------------------------
 Amount fenbendazole in grams     Combination in    Indications for
            per ton               grams per ton           use            Limitations             Sponsor
----------------------------------------------------------------------------------------------------------------
14.5 (16 parts per million)...   ................  Growing turkeys:   Feed                               057926
                                                    For the removal    continuously as
                                                    and control of     the sole ration
                                                    gastrointestinal   for 6 days. For
                                                    worms: round       growing turkeys
                                                    worms, adult and   only.
                                                    larvae
                                                    (Ascaridia
                                                    dissimilis);
                                                    cecal worms,
                                                    adult and larvae
                                                    (Heterakis
                                                    gallinarum), an
                                                    important vector
                                                    of Histomonas
                                                    meleagridis
                                                    (Blackhead).
----------------------------------------------------------------------------------------------------------------

    (2) Swine.

[[Page 58936]]



----------------------------------------------------------------------------------------------------------------
Amount fenbendazole in grams per    Combination in      Indications for
               ton                   grams per ton            use             Limitations           Sponsor
----------------------------------------------------------------------------------------------------------------
(i) 10 to 300 (to provide 9        .................  For the removal     Feed as sole        057926
 milligrams per kilogram (mg/kg)                       and control of:     ration.
 of body weight) given over a 3-                       Adult stage
 to 12-day period.                                     lungworms
                                                       (Metastrongylus
                                                       apri and M.
                                                       pudendotectus);
                                                       adult and larvae
                                                       (L3, 4 stages--
                                                       liver, lung,
                                                       intestinal forms)
                                                       large roundworms
                                                       (Ascaris suum);
                                                       adult stage
                                                       nodular worms
                                                       (Oesophagostomum
                                                       dentatum, O.
                                                       quadrispinulatum)
                                                       ; adult stage
                                                       small stomach
                                                       worms
                                                       (Hyostrongylus
                                                       rubidus); adult
                                                       and larvae (L2,
                                                       3, 4 stages--
                                                       intestinal
                                                       mucosal forms)
                                                       whipworms
                                                       (Trichuris suis);
                                                       adult and larvae
                                                       kidney worms
                                                       (Stephanurus
                                                       dentatus).
(ii) 10 to 80 (to provide 9 mg/   Lincomycin 20.....  As in paragraph     Feed as sole        057926
 kg of body weight).                                   (e)(2)(i) of this   ration. Do not
                                                       section; for        feed to swine
                                                       increased rate of   that weigh more
                                                       gain in growing-    than 250 pounds
                                                       finishing swine.    (lbs); lincomycin
                                                                           as provided by
                                                                           000009 in Sec.
                                                                           510.600(c) of
                                                                           this chapter.
(iii) 10 to 80 (to provide 9 mg/  Lincomycin 40.....  As in paragraph     Feed as sole        057926
 kg of body weight).                                   (e)(2)(i) of this   ration. Do not
                                                       section; for        feed to swine
                                                       control of swine    that weigh more
                                                       dysentery in        than 250 lbs.;
                                                       animals on          lincomycin as
                                                       premises with a     provided by
                                                       history of swine    000009 in Sec.
                                                       dysentery, but      510.600(c) of
                                                       where symptoms      this chapter.
                                                       have not yet
                                                       occurred.
(iv) 10 to 80 (to provide 9 mg/   Lincomycin 100....  As in paragraph     Feed as sole        057926
 kg of body weight).                                   (e)(2)(i) of this   ration. Do not
                                                       section; for the    use within 6 days
                                                       treatment of        of slaughter. Do
                                                       swine dysentery.    not feed to swine
                                                                           that weigh more
                                                                           than 250 lbs.;
                                                                           lincomycin as
                                                                           provided by
                                                                           000009 inSec.
                                                                           510.600(c) of
                                                                           this chapter.
(v) 10 to 80 (to provide 9 mg/kg  Lincomycin 200....  As in paragraph     Feed as sole        057926
 of body weight).                                      (e)(2)(i) of this   ration. Do not
                                                       section; for        use within 6 days
                                                       reduction in the    of slaughter. Do
                                                       severity of swine   not feed to swine
                                                       mycoplasmal         that weigh more
                                                       pneumonia caused    than 250 pound
                                                       by Mycoplasma       (lb); lincomycin
                                                       hyopneumoniae.      as provided by
                                                                           000009 in Sec.
                                                                           510.600(c) of
                                                                           this chapter.
(vi) 10 to 300 (to provide 9 mg/  Bacitracin          Growing/finishing   Feed as sole        046573
 kg of body weight).               methylene           swine: As in        ration. Under
                                   disalicylate 10     paragraph           conditions of
                                   to 30.              (e)(2)(i) of this   continued
                                                       section; for        exposure to
                                                       increased rate of   parasites,
                                                       weight gain and     retreatment may
                                                       improved feed       be needed after 4
                                                       efficiency.         to 6 weeks.
                                                                           Bacitracin
                                                                           methylene
                                                                           disalicylate as
                                                                           provided by
                                                                           046573 in Sec.
                                                                           510.600(c) of
                                                                           this chapter.
(vii) 10 to 300 (to provide 9 mg/ Bacitracin          1. Growing/         1. Growing/         046573
 kg of body weight).               methylene           finishing swine:    finishing swine:
                                   disalicylate 250.   As in paragraph     Feed as sole
                                                       (e)(2)(i) of this   ration. Not for
                                                       section; for        use in growing
                                                       control of swine    and finishing
                                                       dysentery           swine that weigh
                                                       associated with     more than 250
                                                       Treponema           lbs. Diagnosis of
                                                       hyodysenteriae on   swine dysentery
                                                       premises with a     should be
                                                       history of swine    confirmed by a
                                                       dysentery, but      veterinarian when
                                                       where signs of      results are not
                                                       disease have not    satisfactory.
                                                       yet occurred; or    Under conditions
                                                       following an        of continued
                                                       approved            exposure to
                                                       treatment of the    parasites,
                                                       disease condition.  retreatment may
                                                                           be needed after 4
                                                                           to 6 weeks.
                                                                           Bacitracin
                                                                           methylene
                                                                           disalicylate as
                                                                           provided by
                                                                           046573 in Sec.
                                                                           510.600(c) of
                                                                           this chapter.
  ..............................   .................  2. Pregnant sows:   2. Pregnant sows:
                                                       As in paragraph     Feed as sole
                                                       (e)(2)(i) of this   ration. Diagnosis
                                                       section; for        of clostridial
                                                       control of          enteritis should
                                                       clostridial         be confirmed by a
                                                       enteritis in        veterinarian when
                                                       suckling pigs       results are not
                                                       caused by           satisfactory.
                                                       Clostridium         Under conditions
                                                       perfringens.        of continued
                                                                           exposure to
                                                                           parasites,
                                                                           retreatment may
                                                                           be needed after 4
                                                                           to 6 weeks.
                                                                           Bacitracin
                                                                           methylene
                                                                           disalicylate as
                                                                           provided by
                                                                           046573 in Sec.
                                                                           510.600(c) of
                                                                           this chapter.
----------------------------------------------------------------------------------------------------------------

    (3) Cattle--(i) Conditions of use are as follows:

[[Page 58937]]



----------------------------------------------------------------------------------------------------------------
 Amount fenbendazole in grams per  Combination in grams
               ton                        per ton         Indications for use      Limitations         Sponsor
----------------------------------------------------------------------------------------------------------------
(A) 5 mg/kg body weight (2.27 mg/   ...................  For the removal and   Feed as sole ration       057926
 lb).                                                     control of            for one day. Do
                                                          lungworms             not use within 13
                                                          (Dictyocaulus         days of slaughter.
                                                          viviparus);
                                                          barberpole worms
                                                          (Haemonchus
                                                          contortus); brown
                                                          stomach worms
                                                          (Ostertagia
                                                          ostertagi); small
                                                          stomach worms
                                                          (Trichostrongylus
                                                          axei); hookworms
                                                          (Bunostomum
                                                          phlebotomum);
                                                          thread-necked
                                                          intestinal worms
                                                          (Nematodirus
                                                          helvetianus); small
                                                          intestinal worms
                                                          (Cooperia oncophora
                                                          and C. punctata),
                                                          bankrupt worms
                                                          (Trichostrongylus
                                                          colubriformis), and
                                                          nodular worms
                                                          (Oesophagostomum
                                                          radiatum).
(B) 5 mg/kg body weight (2.27 mg/   ...................  As in paragraph       Formulate as              057926
 lb) in a free-choice feed.                               (e)(3)(i)(A) of       specified in
                                                          this section.         paragraph
                                                                                (e)(3)(ii) of this
                                                                                section. Feed a
                                                                                total of 5 mg of
                                                                                fenbendazole per
                                                                                kg (2.27 mg/lb) of
                                                                                body weight to
                                                                                cattle over a 3-
                                                                                to 6-day period.
                                                                                Retreatment may be
                                                                                needed after 4 to
                                                                                6 weeks. Do not
                                                                                slaughter within
                                                                                13 days following
                                                                                last treatment.
----------------------------------------------------------------------------------------------------------------

    (ii) Formulate for use as a free-choice cattle feed as in paragraph 
(e)(3)(i)(B) of this section as follows:

------------------------------------------------------------------------
                                               International
          Ingredient\1\             Percent       feed No.
------------------------------------------------------------
(A) Ingredient:.................
    Copper sulfate..............         0.45      6-01-720
    Dried Cane Molasses.........         3.12      4-04-695
    Monosodium phosphate........        31.16      6-04-288
    Salt (sodium chloride)......        59.00      6-04-152
    Zinc sulfate................         0.76      6-05-556
    Fenbendazole Type A article          5.51
 (20%)..........................
(B) Ingredient:.................
    Dicalcium phosphate.........        32.31      6-00-080
    Limestone...................        17.13      6-02-632
    Magnesium oxide.............         9.79      6-02-756
    Zinc sulfate................         1.47      6-05-556
    Copper sulfate..............         0.29      6-01-720
    Potassium iodide............       0.0098      6-03-759
    Dried Cane Molasses.........         0.98      4-04-695
    Selenium....................       0.0002
    Salt........................        35.93      6-04-152
    Fenbendazole Type A article          2.09
 (20%)..........................
------------------------------------------------------------------------
\1\The content of any added vitamin and trace mineral may be varied;
  however, they should be comparable to those used by the firm for other
  free-choice feeds. Formulation modifications require FDA approval
  prior to marketing. The amount of selenium must comply with published
  regulations.

    (4) Zoo and wildlife animals.

----------------------------------------------------------------------------------------------------------------
                                      Amount        Indications for
         Species/Class             fenbendazole           use            Limitations             Sponsor
----------------------------------------------------------------------------------------------------------------
(i) Feral swine (Sus scrofa)..  3 mg/kg/day for 3  For the removal    Use as complete                    057926
                                 days..             and control of     feed. Prior
                                                    kidney worm        withdrawal of
                                                    (Stephanurus       feed or water
                                                    dentatus),         is not
                                                    roundworm          necessary.
                                                    (Ascaris suum),    Retreatment may
                                                    nodular worm       be required in
                                                    (Oesophagostomum   6 weeks. Do not
                                                    dentatum).         use 14 days
                                                                       before or
                                                                       during the
                                                                       hunting season.
(ii) Ruminants (subfamily       2.5 mg/kg/day for  For the removal    Use as complete                    057926
 Antilopinae, Hippotraginae,     3 days..           and control of     feed. Prior
 Caprinae).                                         small stomach      withdrawal of
                                                    worm               feed or water
                                                    (Trichostrongylu   is not
                                                    s spp.), thread    necessary.
                                                    necked             Retreatment may
                                                    intestinal worm    be required in
                                                    (Nematodirus       6 weeks. Do not
                                                    spp.),             use 14 days
                                                    barberpole worm    before or
                                                    (Haemonchus        during the
                                                    spp.), whipworm    hunting season.
                                                    (Trichuris spp.).

[[Page 58938]]

 
(iii) Rocky mountain bighorn    10 mg/kg/day for   For the removal    Use as complete                    057926
 sheep (Ovis c. canadensis).     3 days..           and control of     feed. Prior
                                                    Protostrongylus    withdrawal of
                                                    spp.               feed or water
                                                                       is not
                                                                       necessary.
                                                                       Retreatment may
                                                                       be required in
                                                                       6 weeks. Do not
                                                                       use 14 days
                                                                       before or
                                                                       during the
                                                                       hunting season.
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    Dated: November 9, 2001.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 01-29352 Filed 11-23-01; 8:45 am]
BILLING CODE 4160-01-S