[Federal Register Volume 63, Number 230 (Tuesday, December 1, 1998)]
[Rules and Regulations]
[Pages 66013-66014]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-31845]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 172

[Docket No. 94F-0454]


Food Additives Permitted for Direct Addition to Food for Human 
Consumption; White Mineral Oil, USP

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 white mineral oil 
as a dust control agent for rough rice at an application rate of 800 
parts per million (ppm). This action is in response to a petition filed 
by Lyondell-Citgo Refining Co., Ltd.

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: Blondell Anderson, Center for Food 
Safety and Applied Nutrition (HFS-206), Food and Drug Administration, 
200 C St. SW., Washington, DC 20204, 202-418-3106.
SUPPLEMENTARY INFORMATION:

I. Introduction

    In a notice published in the Federal Register of January 25, 1995 
(60 FR 4920), FDA announced that a food additive petition (FAP 5A4440) 
had been filed by Lyondell-Citgo Refining Co., Ltd., P.O. Box 2451, 
Houston, TX 77252-2451, proposing that the food additive regulations be 
amended in Sec. 172.878 White mineral oil (21 CFR 172.878), to provide 
for the safe use of white mineral oil as a dust control agent for rough 
rice at an application rate of 800 ppm (0.08 percent of the weight of 
the rice). An application rate of 200 ppm (0.02 percent of the weight 
of the grain) is currently permitted under Sec. 172.878(c) for use on 
wheat, corn, soybean, barley, rice, rye, oats, and sorghum as a dust 
suppressant. On September 17, 1996, the petitioner amended the petition 
to limit its request to the use of white mineral oil of ISO 100 oil 
viscosity (100 centistokes (cSt) at 100 deg.F).

II. Comments

    The agency has received nine comments from rice warehouses and an 
oil supply company in support of the proposed application rate of food 
grade white mineral oil for rough rice indicating that the current 
regulated rate of 200 ppm does not effectively control rice dust. 
Because the comments are consistent with the regulation as set forth in 
the codified section of this document, FDA sees no need to address 
them.

III. Conclusion

    The agency has evaluated all the data in the petition and other 
information and concludes that the proposed use of white mineral oil of 
ISO 100 oil viscosity (centistokes (cSt) at 100  deg.F) is safe for use 
as a dust control agent for rough rice and that the additive will 
achieve its technical effect. Therefore, the agency concludes that the 
food additive regulations should be amended as set forth as follows.
     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.

IV. Environmental Effects

    The agency has carefully considered the potential environmental 
effects of this action. FDA has concluded that the action will not have 
a significant impact on the human environment, and that an 
environmental impact statement is not required. The agency's finding of 
no significant impact and the evidence supporting that finding, 
contained in an environmental assessment, may be seen in the Dockets 
Management Branch (address above) between 9 a.m. and 4 p.m., Monday 
through Friday.

V. Paperwork Reduction Act of 1995

    This final rule contains no collections of information. Therefore, 
clearance by the Office of Management and Budget under the Paperwork 
Reduction Act of 1995 is not required.

VI. Objections

    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

[[Page 66014]]

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 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 172.878 is amended in the table in paragraph (c) by 
adding an entry under the headings ``Use'' and ``Limitation (inclusive 
of all petroleum hydrocarbons that may be used in combination with 
white mineral oil)'' to read as follows:


Sec. 172.878  White mineral oil.

* * * * *
    (c) * * *

 
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                                                           Limitation (inclusive of all petroleum hydrocarbons
                          Use                            that may be used in combination with white mineral oil)
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  *                    *                    *                    *                    *                    *
                                                             *
16. As a dust control agent for rice.                    ISO 100 oil viscosity (100 centistokes (cSt) at 100F)
                                                          applied at a level of no more than 0.08 percent by
                                                          weight of the rice grain.
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    Dated: November 7, 1998.
L. Robert Lake,
Director, Office of Policy, Planning, and Strategic Initiatives, Center 
for Food Safety and Applied Nutrition.
[FR Doc. 98-31845 Filed 11-30-98; 8:45 am]
BILLING CODE 4160-01-F