[Federal Register Volume 66, Number 46 (Thursday, March 8, 2001)]
[Rules and Regulations]
[Pages 13846-13847]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-5612]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 172

[Docket No. 00F-0175]


Food Additives Permitted for Direct Addition to Food for Human 
Consumption; Natamycin (Pimaricin)

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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SUMMARY: The Food and Drug Administration (FDA) is amending the food 
additive regulations to provide for the safe use of natamycin on 
cheese. This action is in response to a petition filed by Cultor Food 
Science, Inc.; DSM Food Specialities; and Protein Technologies 
International.

DATES: This rule is effective March 8, 2001. Submit written objections 
and requests for a hearing by April 9, 2001. The Director of the Office 
of the Federal Register approves the incorporation by reference in 
accordance with 5 U.S.C. 552(a) and 1 CFR part 51 of certain 
publications in 21 CFR 172.155(c), as of March 8, 2001.

ADDRESSES: Submit written objections to the Dockets Management Branch 
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, 
Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Andrew J. Zajac, Center for Food 
Safety and Applied Nutrition (HFS-206), Food and Drug Administration, 
200 C St. SW., Washington, DC 20204-001, 202-418-3095.

SUPPLEMENTARY INFORMATION: In a notice published in the Federal 
Register of January 24, 2000 (65 FR 3719), FDA announced that a food 
additive petition (FAP 0A4704) had been filed by Cultor Food Science, 
Inc., 430 Saw Mill River Rd., Ardsley, NY 10502; DSM Food Specialties, 
700 American Ave., suite 300, King of Prussia, PA 19406; and Protein 
Technologies International, Checkerboard Square, St. Louis, MO 63164. 
The petitioners proposed that the food additive regulations in 
Sec. 172.155 Natamycin (pimaricin) (21 CFR 172.155) be amended by 
listing only the use level of natamycin permitted in cheese and by 
eliminating the reference for the method of application.
    Natamycin is currently approved in Sec. 172.155 for use as an 
antimycotic agent on the surface of cuts and slices of cheese(s). Under 
the current regulation, natamycin may be applied to the surface of cuts 
and slices of cheese to inhibit mold spoilage with the following 
limitations: (1) The additive may be applied as a dry mix containing 
the additive and safe and suitable anticaking agents, resulting in no 
more than 20 parts per million (ppm) of the additive in the finished 
product, or by dipping or spraying, using an aqueous solution 
containing 200 to 300 ppm of the additive; (2) the additive may be 
applied to the surface of those cuts and slices of cheese(s) listed in 
part 133 (21 CFR part 133) only if the cheese standards provide for the 
use of ``safe and suitable'' mold-inhibiting ingredients.
    The agency is revoking the limitations on the application of 
natamycin to the surface of cuts and slices of cheese in 
Sec. 172.155(c)(1) and (c)(2), and is revising Sec. 172.155(c) to set 
forth a limitation for the amount of natamycin on cheese that may 
remain in the finished product, regardless of the method of 
application.
    The agency is setting forth a test method in revised 
Sec. 172.155(c) that will ensure that natamycin does not exceed 20 
milligrams per kilogram (20 ppm) in the finished product. This 
limitation will not restrict the process of application of natamycin to 
cheese nor the physical form (e.g., cuts, slices, or grated) of the 
cheese to which natamycin may be applied. The agency has concluded that 
the dietary exposure to natamycin will not change as a result of the 
use of the new test method for the application of natamycin to cheese 
and new physical forms of cheese to which natamycin may be applied. 
Further, because of the existing limitation in part 133 for when ``safe 
and suitable'' mold inhibiting ingredients, such as natamycin, may be 
used in cheese, the agency has determined that repeating such 
limitations in Sec. 172.155 is not necessary. Therefore, omitting the 
previous limitation in Sec. 172.155(c)(2) from revised Sec. 172.155(c) 
does not change the varieties of cheeses in which natamycin may be 
used. Consequently, because the dietary exposure to natamycin in cheese 
remains the same as considered in the previous safety assessment for 
Sec. 177.155(c)(1) and (c)(2), no new safety issues are raised and no 
new safety evaluation is needed for this rule.
    In accordance with Sec. 171.1(h) (21 CFR 171.1(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 the 
Center for Food Safety and Applied Nutrition by appointment with the 
information contact person listed above. As provided in Sec. 171.1(h), 
the agency will delete from the documents any materials that are not 
available for public disclosure before making the documents available 
for inspection.
    The agency has previously considered the environmental effects of 
this rule as announced in the notice of filing for FAP 0A4704. No new 
information or comments have been received that would affect the 
agency's previous determination that there is no significant impact on 
the human environment and that an environmental impact statement is not 
required.
    This final rule contains no collection of information. Therefore, 
clearance by the Office of Management and Budget under the Paperwork 
Reduction Act of 1995 is not required.
    Any person who will be adversely affected by this regulation may at 
any time file with the Dockets Management Branch (address above) 
written objections by April 9, 2001. 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 Dockets Management Branch

[[Page 13847]]

between 9 a.m. and 4 p.m., Monday through Friday.

List of Subjects in 21 CFR Part 172

    Food additives, Incorporation by reference, Reporting and 
recordkeeping requirements.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Food and Drugs and 
redelegated to the Director, Center for Food Safety and Applied 
Nutrition, 21 CFR part 172 is amended as follows:

PART 172--FOOD ADDITIVES PERMITTED FOR DIRECT ADDITION TO FOOD FOR 
HUMAN CONSUMPTION

    1. The authority citation for 21 CFR part 172 continues to read as 
follows:

    Authority: 21 U.S.C. 321, 341, 342, 348, 371, 379e.

    2. Section 172.155 is amended by revising paragraph (c) to read as 
follows:


Sec. 172.155  Natamycin (pimaricin).

* * * * *
    (c) The additive may be applied on cheese, as an antimycotic, in 
amounts not to exceed 20 milligrams per kilogram (20 parts per million) 
in the finished product as determined by International Dairy Federation 
(IDF) Standard 140A:1992, ``Cheese and Cheese Rind-Determination of 
Natamycin Content-Method by Molecular Absorption Spectrometry and by 
High-Performance Liquid Chromatography,'' which is incorporated by 
reference. The Director of the Office of the Federal Register approves 
this incorporation by reference in accordance with 5 U.S.C. 552(a) and 
1 CFR part 51. Copies are available from the Division of Product Policy 
(HFS-206), Center for Food Safety and Applied Nutrition, Food and Drug 
Administration, 200 C St. SW., Washington, DC 20204, or may be examined 
at the Center for Food Safety and Applied Nutrition's Library, 200 C 
St. SW., rm. 3321, Washington, DC, or at the Office of the Federal 
Register, 800 North Capitol St. NW., suite 700, Washington, DC.

    Dated: February 9, 2001.
L. Robert Lake,
Director of Regulations and Policy, Center for Food Safety and Applied 
Nutrition.
[FR Doc. 01-5612 Filed 3-7-01; 8:45 am]
BILLING CODE 4160-01-F