[Federal Register Volume 63, Number 230 (Tuesday, December 1, 1998)]
[Rules and Regulations]
[Pages 66014-66015]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-31855]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 172

[Docket No. 98F-0063]


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 a dry form of 
natamycin as an antimycotic in cheeses. This action is in response to a 
petition filed by Protein Technologies International, Inc.

DATES: This regulation is effective December 1, 1998; written 
objections and requests for a hearing by December 31, 1998.
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: JoAnn Ziyad, Center for Food Safety 
and Applied Nutrition (HFS-206), Food and Drug Administration, 200 C 
St. SW., Washington, DC 20204, 202-418-3116.

SUPPLEMENTARY INFORMATION: In a notice published in the Federal 
Register of February 11, 1998 (63 FR 6945), FDA announced that a food 
additive petition (FAP 8A4581) had been filed by Protein Technologies 
International, Checkerboard Sq., St. Louis, MO 63164. The petition 
proposes to amend the food additive regulations in Sec. 172.155 
Natamycin (pimaricin) (21 CFR 172.155) to provide for the safe use of a 
dry form of the food additive for use on the surfaces of cuts and 
slices of cheese to inhibit mold spoilage, in accordance with various 
standards of identity for cheeses that allow the use of antimycotics 
and anticaking agents.
    FDA received two comments from the food industry on the use of the 
dry mix of natamycin and cellulose on cheese to inhibit mold spoilage. 
Both comments favored the petitioned use of the additive. One comment 
listed several reasons for supporting the current petitioned use. They 
include possible extension of shelf life of shredded cheese, reduction 
of risks associated with antimycotic suspension spray application and 
minimal new technology investment by utilizing existing anticaking 
agent application technology. However, the other comment stated that 
``We realize that natamycin is permitted as a spray on the surface of 
cheese, but we are not comfortable with that method of application on 
grated cheese. We would like to test the efficacy of the method 
proposed in the cited petition.''
    FDA finds that the petitioner does not seek approval either for the 
use of the wet or dry application of the additive on grated cheese. The 
petitioner requests that FDA amend the food additive regulation for 
natamycin (pimaricin) found in Sec. 172.155 to allow for the use of a 
dry form of the food additive only on the surfaces of cuts and slices 
of cheese to inhibit mold spoilage, and this does not extend to use of 
the additive on grated or shredded cheese. Therefore, the comments on 
grated or shredded cheese are outside the scope of this rulemaking.
    Natamycin is currently approved in Sec. 172.155 for use as an 
antimycotic agent on the surfaces of cuts and slices of cheese(s). 
Natamycin may be used on surfaces of cuts and slices of a cheese listed 
in 21 CFR part 133 only if the standards for such cheese provides for 
or the use of ``safe and suitable'' mold-inhibiting ingredients. The 
subject additive is defined in Sec. 172.155 and may be applied by 
dipping or by spraying, using an aqueous solution containing 200 to 300 
parts per million (ppm) of the additive. The proposed use is for the 
application of natamycin to cuts and slices of cheese as a dry mixture 
with safe and suitable anticaking agents, such as cellulose.
    FDA has evaluated the data in the petition and other relevant 
material. As part of its review, FDA evaluated data on the technical 
effect of the additive, its stability, and the change in exposure 
resulting from the use of a dry mixture of natamycin and cellulose 
anticaking agent. The petitioner provided data to establish that a 
level of up to 20 ppm natamycin in the finished product is needed to 
obtain the same antimycotic effect as from the liquid application.
    The petitioner, by measuring the antimycotic effect of a dry 
mixture of natamycin and cellulose on several

[[Page 66015]]

cheeses resulting in no more than 20 ppm of natamycin in these cheeses, 
demonstrated that the additive will achieve its intended technical 
effect. The application of natamycin in dry form does not change the 
chemical composition of the additive, the uses in food, the use levels 
and, therefore, the dietary exposure to natamycin. Furthermore, the use 
of natamycin in the dry form does not result in any manufacturing 
changes that would affect the safety of the additive for this proposed 
use. The use of comparable levels of other safe and suitable anticaking 
agents, in addition to cellulose, would not change this conclusion. 
Therefore, the agency's safety evaluation of natamycin for the approved 
use in an aqueous application by dipping or spraying (47 FR 26823, June 
22, 1982, as amended at 50 FR 49536, December 3, 1985) supports this 
proposed use of natamycin in dry form. Based on this information, the 
agency concludes that the proposed use of the additive is safe, that 
the additive will achieve its intended technical effect, and therefore, 
that the regulations in Sec. 172.155 should be amended.
    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 8A4581 (63 FR 
6945, February 11, 1998). 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 on or before December 31, 1998, file with the Dockets 
Management Branch (address above) written objections thereto. 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 shall be 
submitted and shall 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 
between 9 a.m. and 4 p.m., Monday through Friday.

List of Subjects in 21 CFR Part 172

    Food additives, Reporting and recordkeeping requirements.
    Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Foods 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)(1) to read 
as follows:


Sec.  172.155   Natamycin (pimaricin).

* * * * *
    (c) * * *
    (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 of the additive in the finished product, or 
by dipping or spraying, using an aqueous solution containing 200 to 300 
parts per million of the additive.
* * * * *

    Dated: November 7, 1998.
 L. Robert Lake,
 Director, Office of Policy, Planning and Strategic Initiatives, Center 
for Food Safety and Applied Nutrition.
[FR Doc. 98-31855 Filed 11-30-98; 8:45 am]
BILLING CODE 4160-01-F