[Federal Register: April 13, 2004 (Volume 69, Number 71)]
[Rules and Regulations]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
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;
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule.
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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&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@example.com.
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
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.
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
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.
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
1. The authority citation for 21 CFR part 573 continues to read as
Authority: 21 U.S.C. 321, 342, 348.
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
(a) The additive is a stereoisomer of 22-[(3-amino-3,6,dideoxy-
6,11,28-trioxatricyclo[220.127.116.11\5\, \7\] octacosa-8,14,16,18,20-
pentaene-25-carboxylic acid with the empirical formula
(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
(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