[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
