[Federal Register Volume 65, Number 17 (Wednesday, January 26, 2000)]
[Rules and Regulations]
[Pages 4111-4112]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-1789]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 556 and 558


New Animal Drugs for Use in Animal Feeds; Ractopamine 
Hydrochloride

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Final rule.

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SUMMARY:  The Food and Drug Administration (FDA) is amending the animal 
drug regulations to reflect approval of a new animal drug application 
(NADA) filed by Elanco Animal Health, A Division of Eli Lilly and Co. 
The NADA provides for use of a ractopamine hydrochloride Type A 
medicated article to make Type B and Type C medicated swine feeds. The 
Type C medicated finishing swine feeds are used for increased rate of 
weight gain, improved feed efficiency, and increased carcass leanness. 
The regulations are also amended to provide for an acceptable daily 
intake (ADI) for ractopamine and tolerances for drug residues in edible 
products derived from treated swine.

DATES:  This rule is effective January 26, 2000.

FOR FURTHER INFORMATION CONTACT:  Charles J. Andres, Center for 
Veterinary Medicine (HFV-128), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-827-1600.

SUPPLEMENTARY INFORMATION:  Elanco Animal Health, A Division of Eli 
Lilly and Co., Lilly Corporate Center, Indianapolis, IN 46285, filed 
NADA 140-863 that provides for use of Paylean (ractopamine 
hydrochloride) Type A medicated article to make Type B and Type C 
medicated swine feeds. The Type C medicated finishing swine feeds must 
contain at least 16 percent crude protein. Feeds containing 4.5 grams 
per ton (g/t) ractopamine hydrochloride are used for increased rate of 
weight gain, improved feed efficiency, and increased carcass leanness. 
Feeds containing 4.5 to 18 g/t ractopamine hydrochloride are used for 
improved feed efficiency and increased carcass leanness. The NADA is 
approved as of December 22, 1999, and the regulations in part 558 (21 
CFR part 558) are amended by adding Sec. 558.500 to reflect the 
approval. The basis for approval is discussed in the freedom of 
information summary.
    Furthermore, Sec. 558.4(d) is amended in the ``Category I'' table 
by adding an entry for ``ractopamine'' to provide for the assay limits 
for Type A medicated articles and Type B/C medicated feeds and the 
maximum Type B medicated feed level.
    In addition, part 556 (21 CFR part 556) is amended by adding 
Sec. 556.570 to establish an ADI for total ractopamine and tolerances 
for residues of ractopamine in edible tissues of treated swine.
    In accordance with the freedom of information provisions of 21 CFR 
part and Sec. 514.11(e)(2)(ii), a summary of safety and effectiveness 
data and information submitted to support approval of this application 
may be seen in the Dockets Management Branch (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852, 
between 9 a.m. and 4 p.m., Monday through Friday.
    Under section 512(c)(2)(F)(i) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 360b(c)(2)(F)(i)), this approval for food-
producing animals qualifies for 5 years of marketing exclusivity 
beginning December 22, 1999, because no active ingredient (including 
any ester or salt of the active ingredient) has been previously 
approved for any other application filed under section 512(b)(1).
    The agency has carefully considered the potential environmental 
effects of this action. FDA has concluded that the action will not have 
a significant impact on the human environment, and that an 
environmental impact statement is not required. The agency's finding of 
no significant impact and the evidence supporting that finding, 
contained in an environmental assessment, may be seen in the Dockets 
Management Branch (address above) between 9 a.m. and 4 p.m., Monday 
through Friday.
    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.

[[Page 4112]]

List of Subjects

21 CFR Part 556

    Animal drugs, Foods.

21 CFR Part 558

    Animal drugs, Animal feeds.
    Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Food and Drugs and 
redelegated to the Center for Veterinary Medicine, 21 CFR parts 556 and 
558 are amended as follows:

PART 556--TOLERANCES FOR RESIDUES OF NEW ANIMAL DRUGS IN FOOD

    1. The authority citation for 21 CFR part 556 continues to read as 
follows:

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

    2. Section 556.570 is added to subpart B to read as follows:


Sec. 556.570  Ractopamine.

    (a) Acceptable daily intake (ADI). The ADI for total residues of 
ractopamine is 1.25 micrograms ractopamine hydrochloride per kilogram 
of body weight per day.
    (b) Tolerances. Swine--Tolerances are established for residues of 
ractopamine hydrochloride parent (marker residue) in edible swine 
tissues of 0.05 part per million (ppm) in muscle, and 0.15 ppm in liver 
(target tissue). Residues of ractopamine in swine muscle are not 
indicative of the safety of residues in other edible tissue.

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

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

    Authority:  21 U.S.C. 360b, 371.
    4. Section 558.4 is amended in paragraph (d) in the ``Category I'' 
table by adding an entry alphabetically for ``Ractopamine'' to read as 
follows:


Sec. 558.4  Medicated feed applications.

* * * * *
    (d) * * *

                               CATEGORY I
------------------------------------------------------------------------
                                                          Assay limits
       Drug           Assay limits     Type B maximum   percent \1\ type
                    percent \1\ type       (200x)            B/C \2\
---------------------------A--------------------------------------------
  *                    *                    *                    *
                   *                    *                    *
Ractopamine        85-105             1.8 g/lb (0.4%)   80-110
  *                    *                    *                    *
                   *                    *                    *
------------------------------------------------------------------------
\1\ Percent of labeled amount.
\2\ Values given represent ranges for either Type B or Type C medicated
  feeds. For those drugs that have two range limits, the first set is
  for a Type B medicated feed and the second set is for a Type C
  medicated feed. These values (ranges) have been assigned in order to
  provide for the possibility of dilution of a Type B medicated feed
  with lower assay limits to make Type C medicated feed.

* * * * *

    5. Section 558.500 is added to subpart B to read as follows:


Sec. 558.500  Ractopamine.

    (a) Approvals. Type A medicated articles: 9 grams of ractopamine 
hydrochloride per pound to 000986 in Sec. 510.600(c) of this chapter.
    (b) [Reserved]
    (c) Related tolerances. See Sec. 556.570 of this chapter.
    (d) Conditions of use. (1) Swine--(i) Amount. 4.5 grams of 
ractopamine hydrochloride per ton of Type C feed for increased rate of 
weight gain, improved feed efficiency, and increased carcass leanness; 
4.5 to 18 grams per ton for improved feed efficiency and increased 
carcass leanness; fed in a complete ration containing at least 16 
percent crude protein to finishing swine from 150 to 240 pounds body 
weight.
    (ii) Limitations. Feed continuously as sole ration. Not for use in 
breeding swine.
    (2) [Reserved]

    Dated: January 13, 2000.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 00-1789 Filed 1-25-00; 8:45 am]
BILLING CODE 4160-01-F