[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.
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(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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* * * * * *
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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