69 FR 71 pgs. 19320-19321 - Food Additives Permitted in Feed and Drinking Water of Animals;Natamycin
Type: RULEVolume: 69Number: 71Pages: 19320 - 19321
Docket number: [Docket No. 1995F-0221]
FR document: [FR Doc. 04-8249 Filed 4-12-04;8:45 am]
Agency: Health and Human Services Department
Sub Agency: Food and Drug Administration
Official PDF Version: PDF Version
DEPARTMENT OF HEALTH AND HUMANSERVICES
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.
SUMMARY:
The Food and Drug Administration (FDA) isamending the regulations for food additives permitted in feed and drinkingwater of animals to provide for the safe use of natamycin in broilerchicken feeds. Natamycin will be added to broiler chicken feed at a levelof 11 parts per million (ppm) to retard the growth of Aspergillusparasiticus in the feed for up to 14 days after the addition ofnatamycin. This action is in response to a food additive petition filed byArkion Life Sciences of Wilmington, DE.
DATES:
This rule is effective April 13, 2004. Submit writtenobjections and requests for a hearing by June 14, 2004.
ADDRESSES:
Submit written objections and requests for ahearing to the Division of Dockets Management (HFA-305), Food andDrug 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, Centerfor Veterinary Medicine (HFV-222), Food and Drug Administration, 7500Standish Pl., Rockville, MD 20855, 301-827-6653, e-mail: kekelman@cvm.fda.gov .
SUPPLEMENTARY INFORMATION:
I. Background
In a notice published in the Federal Register of September20, 1995 (60 FR 48715), FDA announced that a food additive petition (animaluse) (FAP 2234) had been filed by DuCoa L.P., P. O. Box 219, Highland, IL62249-1105. The petition proposed that part 573- FoodAdditives Permitted in Feed and Drinking Water of Animals (21 CFR part573) be amended to provide for the safe use of natamycin in broiler chickenfeeds, at the rate of 11 ppm, for retarding growth of A.parasiticus , Penicillium rubrum , and Fusariummoniliforme . The notice of filing of FAP 2234 provided for a 60-daycomment period. No comments have been received.
On June 6, 1996, the Center for Veterinary Medicine (CVM) denied thepetition because data submitted in support of some sections (utility,proposed purposes and amounts, proposed regulation, and proposed label) ofthe petition were determined to be inadequate. At that time, CVM informedDuCoa L.P., that the company could either amend the petition by submittingadditional data to address concerns expressed in the letter, or withdrawthe petition as provided for in § 571.7 (21 CFR 571.7).
On July 31, 2001, the sponsor amended the petition to seek approval forthe use of natamycin in broiler chicken feeds, at a level of 11 ppm toretard the growth of A. parasiticus in the feeds for up to 14days.
In a letter that CVM received from the petitioner on March 20, 2003, thepetitioner informed FDA that sponsorship of natamycin for the intended usehad been transferred from DuCoa L.P., Highlands, IL, to Arkion LifeSciences, 3521 Silverside Rd., Wilmington, DE 19810. The transfer ofsponsorship was announced in the Federal Register of May 22,2003 (68 FR 28010).Data submitted by the sponsor in support of the petition permit anindependent evaluation of the ability of natamycin to achieve the intendedpurpose in a safe manner. The sponsor submitted data that show that thislevel of natamycin will not present a human food safety concern. Thepetition also includes satisfactory information about the chemical identityof natamycin and indicates that natamycin will achieve its intended effectin a manner that is safe to broiler chickens consuming the treatedfeed.
II. Conclusion
FDA concludes that the data establish the safety and utility ofnatamycin (CAS No. 7681-93-8) for use as proposed and that theregulations should be amended as set forth in this document.
III. Public Disclosure
In accordance with § 571.1(h), the petition and the documents thatFDA considered and relied upon in reaching its decision to approve thepetition are available for inspection at CVM (see ADDRESSES )by appointment with the information contact person (see FOR FURTHER INFORMATION CONTACT ). As provided in § 571.1(h), theagency will delete from the documents any materials that are not availablefor public disclosure before making the documents available forinspection.
IV. Environmental Impact
The agency has determined under 21 CFR 25.32(r) that this action is of atype that does not individually or cumulatively have a significant effecton the human environment. Therefore, neither an environmental assessmentnor an environmental impact statement is required.
V. Objections and Hearing Requests
Any person who will be adversely affected by this regulation may filewith the Division of Dockets Management (see ADDRESSES )written or electronic objections. Each objection shall be separatelynumbered, and each numbered objection shall specify with particularity theprovisions of the regulation to which objection is made and the grounds forthe objection. Each numbered objection on which a hearing is requestedshall specifically so state. Failure to request a hearing for anyparticular objection shall constitute a waiver of the right to a hearing onthat objection. Each numbered objection for which a hearing is requestedshall include a detailed description and analysis of the specific factualinformation intended to be presented in support of the objection in theevent that a hearing is held. Failure to include such a description andanalysis for any particular objection shall constitute a waiver of theright to a hearing on the objection. Three copies of all documents are tobe submitted and are to be identified with the docket number found inbrackets in the heading of this document. Any objections received inresponse to the regulation may be seen in the Division of DocketsManagement 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 ofFood and Drugs and redelegated to the Center for Veterinary Medicine, 21CFR part 573 is amended as follows:
PART 573-FOOD ADDITIVES PERMITTED IN FEED AND DRINKING WATER OFANIMALS
1. The authority citation for 21 CFR part 573 continues to read asfollows:
Authority:
21 U.S.C. 321, 342, 348.
2. Section 573.685 is added to read as follows:
§ 573.685 Natamycin.
The food additive natamycin (CAS No. 7681-93-8) may besafely used in broiler chicken feeds in accordance with the followingspecifications:
(a) The additive is a stereoisomer of22-[(3-amino-3,6,dideoxy--D-mannopyranosyl)oxy]-1,3,26-trihydroxy-12-methyl-10-oxo-6,11,28-trioxatricyclo[22.3.1.05 ,7 ] octacosa-8,14,16,18,20-pentaene-25-carboxylic acid with theempirical formula C 33 H 47 NO 13 .
(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 14days after the addition of natamycin.
(d) Each pound (454 grams (g)) of the premix shall contain 434 (g) ofcalcium carbonate, 10 g of natamycin activity, and 10 g of lactose. Thepremix 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 alevel of 11 parts per million (ppm). The premix shall be thoroughly mixedinto the dry components of the broiler chicken feed before adding theliquid components. Broiler feeds to which the natamycin premix is addedshall be used within 4 weeks of addition of the premix.
(e) To assure the safe use of the additive, the label or labeling ofthe additive shall bear, in addition to other information required by theFederal 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, theadditive, and lactose and their proportions in the premix as prescribedunder paragraph (d) of this section.
(3) Adequate directions for use to ensure a broiler chicken feed thatis in compliance with the limitations prescribed in paragraph (d) of thissection.
(4) An appropriate cautionary statement: "Caution: Store in atightly-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 adversereactions experienced by users, or to request a copy of the Material SafetyData 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 CODE4160-01-S