[Federal Register Volume 69, Number 71 (Tuesday, April 13, 2004)]
[Rules and Regulations]
[Pages 19320-19321]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-8249]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 573

[Docket No. 1995F-0221]


Food Additives Permitted in Feed and Drinking Water of Animals; 
Natamycin

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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SUMMARY: The Food and Drug Administration (FDA) is amending the 
regulations for food additives permitted in feed and drinking water of 
animals to provide for the safe use of natamycin in broiler chicken 
feeds. Natamycin will be added to broiler chicken feed at a level of 11 
parts per million (ppm) to retard the growth of Aspergillus parasiticus 
in the feed for up to 14 days after the addition of natamycin. This 
action is in response to a food additive petition filed by Arkion Life 
Sciences of Wilmington, DE.

DATES: This rule is effective April 13, 2004. Submit written objections 
and requests for a hearing by June 14, 2004.

ADDRESSES: Submit written objections and requests for a hearing to the 
Division of Dockets Management (HFA-305), Food and Drug Administration, 
5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic 
objections to http://www.fda.gov/dockets/ecomments.

FOR FURTHER INFORMATION CONTACT: Karen Ekelman, Center for Veterinary 
Medicine (HFV-222), Food and Drug Administration, 7500 Standish Pl., 
Rockville, MD 20855, 301-827-6653, e-mail: [email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    In a notice published in the Federal Register of September 20, 1995 
(60 FR 48715), FDA announced that a food additive petition (animal use) 
(FAP 2234) had been filed by DuCoa L.P., P. O. Box 219, Highland, IL 
62249-1105. The petition proposed that part 573--FoodAdditives 
Permitted in Feed and Drinking Water of Animals (21 CFR part 573) be 
amended to provide for the safe use of natamycin in broiler chicken 
feeds, at the rate of 11 ppm, for retarding growth of A. parasiticus, 
Penicillium rubrum, and Fusarium moniliforme. The notice of filing of 
FAP 2234 provided for a 60-day comment period. No comments have been 
received.
    On June 6, 1996, the Center for Veterinary Medicine (CVM) denied 
the petition because data submitted in support of some sections 
(utility, proposed purposes and amounts, proposed regulation, and 
proposed label) of the petition were determined to be inadequate. At 
that time, CVM informed DuCoa L.P., that the company could either amend 
the petition by submitting additional data to address concerns 
expressed in the letter, or withdraw the petition as provided for in 
Sec.  571.7 (21 CFR 571.7).
    On July 31, 2001, the sponsor amended the petition to seek approval 
for the use of natamycin in broiler chicken feeds, at a level of 11 ppm 
to retard the growth of A. parasiticus in the feeds for up to 14 days.
    In a letter that CVM received from the petitioner on March 20, 
2003, the petitioner informed FDA that sponsorship of natamycin for the 
intended use had been transferred from DuCoa L.P., Highlands, IL, to 
Arkion Life Sciences, 3521 Silverside Rd., Wilmington, DE 19810. The 
transfer of sponsorship was announced in the Federal Register of May 
22, 2003 (68 FR 28010). Data submitted by the sponsor in support of the 
petition permit an independent evaluation of the ability of natamycin 
to achieve the intended purpose in a safe manner. The sponsor submitted 
data that show that this level of natamycin will not present a human 
food safety concern. The petition also includes satisfactory 
information about the chemical identity of natamycin and indicates that 
natamycin will achieve its intended effect in a manner that is safe to 
broiler chickens consuming the treated feed.

II. Conclusion

    FDA concludes that the data establish the safety and utility of 
natamycin (CAS No. 7681-93-8) for use as proposed and that the 
regulations should be amended as set forth in this document.

III. Public Disclosure

    In accordance with Sec.  571.1(h), the petition and the documents 
that FDA considered and relied upon in reaching its decision to approve 
the petition are available for inspection at CVM (see ADDRESSES) by 
appointment with the information contact person (see FOR FURTHER 
INFORMATION CONTACT). As provided in Sec.  571.1(h), the agency will 
delete from the documents any materials that are not available for 
public disclosure before making the documents available for inspection.

IV. Environmental Impact

    The agency has determined under 21 CFR 25.32(r) that this action is 
of a type that does not individually or cumulatively have a significant 
effect on the human environment. Therefore, neither an environmental 
assessment nor an environmental impact statement is required.

V. Objections and Hearing Requests

    Any person who will be adversely affected by this regulation may 
file with the Division of Dockets Management (see ADDRESSES) written or 
electronic objections. Each objection shall be separately numbered, and 
each numbered objection shall specify with particularity the provisions 
of the regulation to which objection is made and the grounds for the 
objection. Each numbered objection on which a hearing is requested 
shall specifically so state. Failure to request a hearing for any 
particular objection shall constitute a waiver of the right to a 
hearing on that objection. Each numbered objection for which a hearing 
is requested shall

[[Page 19321]]

 include a detailed description and analysis of the specific factual 
information intended to be presented in support of the objection in the 
event that a hearing is held. Failure to include such a description and 
analysis for any particular objection shall constitute a waiver of the 
right to a hearing on the objection. Three copies of all documents are 
to be submitted and are to be identified with the docket number found 
in brackets in the heading of this document. Any objections received in 
response to the regulation may be seen in the Division of Dockets 
Management between 9 a.m. and 4 p.m., Monday through Friday.

List of Subjects in 21 CFR Part 573

    Animal feeds, Food additives.

0
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 573 is 
amended as follows:

PART 573--FOOD ADDITIVES PERMITTED IN FEED AND DRINKING WATER OF 
ANIMALS

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1. The authority citation for 21 CFR part 573 continues to read as 
follows:

    Authority:  21 U.S.C. 321, 342, 348.

0
2. Section 573.685 is added to read as follows:


Sec.  573.685  Natamycin.

     The food additive natamycin (CAS No. 7681-93-8) may be safely used 
in broiler chicken feeds in accordance with the following 
specifications:
    (a) The additive is a stereoisomer of 22-[(3-amino-3,6,dideoxy-
[Beta]-D-mannopyranosyl)oxy]-1,3,26-trihydroxy-12-methyl-10-oxo-
6,11,28-trioxatricyclo[22.3.1.0\5\, \7\] octacosa-8,14,16,18,20-
pentaene-25-carboxylic acid with the empirical formula 
C33H47NO13.
    (b) The additive shall conform to U.S.P. specifications.
    (c) The additive (as part of a premix composed of calcium 
carbonate, natamycin, and lactose) is used for retarding the growth of 
Aspergillus parasiticus in broiler chicken feeds for up to 14 days 
after the addition of natamycin.
    (d) Each pound (454 grams (g)) of the premix shall contain 434 (g) 
of calcium carbonate, 10 g of natamycin activity, and 10 g of lactose. 
The premix shall be mixed into broiler chicken feed at the rate of 1 
pound (0.454 kilograms (kg)) per ton (908 kg) of feed to provide 
natamycin at a level of 11 parts per million (ppm). The premix shall be 
thoroughly mixed into the dry components of the broiler chicken feed 
before adding the liquid components. Broiler feeds to which the 
natamycin premix is added shall be used within 4 weeks of addition of 
the premix.
    (e) To assure the safe use of the additive, the label or labeling 
of the additive shall bear, in addition to other information required 
by the Federal Food, Drug, and Cosmetic Act, the following:
    (1) The name and CAS number of the additive, and its purpose.
    (2) A listing of ingredients consisting of calcium carbonate, the 
additive, and lactose and their proportions in the premix as prescribed 
under paragraph (d) of this section.
    (3) Adequate directions for use to ensure a broiler chicken feed 
that is in compliance with the limitations prescribed in paragraph (d) 
of this section.
    (4) An appropriate cautionary statement: ``Caution: Store in a 
tightly-closed, light-resistant container in a cool, dry place.''
    (5) An expiration date of 1 year from the date of manufacture.
    (6) A contact address and telephone number for reporting adverse 
reactions experienced by users, or to request a copy of the Material 
Safety Data Sheet for natamycin.

    Dated: March 24, 2004.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 04-8249 Filed 4-12-04; 8:45 am]
BILLING CODE 4160-01-S