[Federal Register Volume 59, Number 44 (Monday, March 7, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-5128]


[[Page Unknown]]

[Federal Register: March 7, 1994]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 73

[Docket No. 90C-0453]

 

Listing of Color Additives Exempt From Certification; Synthetic 
Iron Oxide

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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SUMMARY: The Food and Drug Administration (FDA) is amending the color 
additive regulations to provide for the safe use of synthetic iron 
oxide in human food. This action is in response to a petition filed by 
Teepak, Inc.

DATES: Effective April 7, 1994, except as to any provisions that may be 
stayed by the filing of proper objections; written objections by April 
6, 1994.

ADDRESSES: Submit written objections to the Dockets Management Branch 
(HFA-305), Food and Drug Administration, rm. 1-23, 12420 Parklawn Dr., 
Rockville, MD 20857.

FOR FURTHER INFORMATION CONTACT: Rosalie M. Angeles, Center for Food 
Safety and Applied Nutrition (HFS-207), Food and Drug Administration, 
200 C St. SW., Washington, DC 20204, 202-254-9528.

SUPPLEMENTARY INFORMATION: In a notice published in the Federal 
Register of January 11, 1991 (56 FR 1197), FDA announced that a color 
additive petition (CAP 0C0228) had been filed by Teepak, Inc., P.O. Box 
11925, Columbia, SC 29211. The petition proposed that the color 
additive regulations in Sec. 73.1200 Synthetic iron oxide (21 CFR 
73.1200) be amended to provide for the safe use of synthetic iron oxide 
as a color additive in human food, specifically in sausage casings. The 
petition was filed under section 721 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 379e). The agency erred in citing the specific 
section number to be amended as Sec. 73.1200 because that section is in 
Subpart B--Drugs of part 73 (21 CFR part 73); the amendment is more 
accurately placed in Sec. 73.200 (21 CFR 73.200) in Subpart A--Foods. 
The agency finds, however, that because the regulatory action was 
described properly in the notice, the error in citation will not 
mislead anyone and an amended notice is not necessary.
    Based on data contained in the petition and other relevant 
information, FDA concludes that the petitioned use of synthetic iron 
oxide as a color additive in human food is suitable and safe. The 
agency, therefore, is amending Sec. 73.200 to provide for the use of 
synthetic iron oxide as a color additive in human food.
    The existing regulation for food use of synthetic iron oxide in 
Sec. 73.200 contains a set of specifications for heavy metals which FDA 
established when it listed the color additive for use in dog and cat 
food (33 FR 9953, July 11, 1968). However, it is the agency's policy to 
limit human exposure to heavy metal contaminants in food to the lowest 
levels possible. Therefore, for human food use, the agency is 
restricting the levels for lead, arsenic, and mercury in synthetic iron 
oxide to no more than 10 parts per million (ppm), 3 ppm, and 1 ppm, 
respectively.
    In accordance with Sec. 71.15 (21 CFR 71.15), 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 (address above) by appointment with 
the information contact person listed above. As provided in Sec. 71.15, 
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 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.
    Any person who will be adversely affected by this regulation may at 
any time on or before April 6, 1994, 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. FDA will publish 
notice of the objections that the agency has received or lack thereof 
in the Federal Register.

List of Subjects in 21 CFR Part 73

    Color additives, Cosmetics, Drugs, Medical devices.

    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 73 is amended as follows:

PART 73--LISTING OF COLOR ADDITIVES EXEMPT FROM CERTIFICATION

    1. The authority citation for 21 CFR part 73 is revised to read as 
follows:

    Authority: Secs. 201, 401, 402, 403, 409, 501, 502, 505, 601, 
602, 701, 721 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
321, 341, 342, 343, 348, 351, 352, 355, 361, 362, 371, 379e).

    2. Section 73.200 is amended by revising paragraphs (a)(2), (b), 
and (c) to read as follows:


Sec. 73.200  Synthetic iron oxide.

    (a) * * *
    (2) Color additive mixtures for food use made with synthetic iron 
oxide may contain only those diluents that are suitable and that are 
listed in this subpart as safe for use in color additive mixtures for 
coloring foods.
    (b) Specifications. (1) Synthetic iron oxide for human food use 
shall conform to the following specifications:

Arsenic (as As), not more than 3 parts per million.
Lead (as Pb), not more than 10 parts per million.
Mercury (as Hg) , not more than 1 part per million.
    (2) Synthetic iron oxide for dog and cat food use shall conform to 
the following specifications:

Arsenic (as As), not more than 5 parts per million.
Lead (as Pb), not more than 20 parts per million.
Mercury (as Hg), not more than 3 parts per million.
    (c) Uses and restrictions. (1) Synthetic iron oxide may be safely 
used for the coloring of sausage casings intended for human consumption 
in an amount not exceeding 0.10 percent by weight of the finished food.
    (2) Synthetic iron oxide may be safely used for the coloring of dog 
and cat foods in an amount not exceeding 0.25 percent by weight of the 
finished food.
* * * * *

    Dated: February 25, 1994.
 Fred R. Shank,
 Director, Center for Food Safety and Applied Nutrition.
[FR Doc. 94-5128 Filed 3-4-94; 8:45 am]
BILLING CODE 4160-01-F