[Federal Register Volume 61, Number 138 (Wednesday, July 17, 1996)]
[Rules and Regulations]
[Pages 37208-37210]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-18072]
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[[Page 37209]]
DEPARTMENT OF HEALTH AND HUMAN SERVICES
21 CFR Part 176
[Docket No. 96F-0070]
Indirect Food Additives: Paper and Paperboard Components
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 additional safe use of ammonium
zirconium lactate-citrate complexes for use as insolubilizers with
protein binders in coatings for paper and paperboard intended for food-
contact applications. This action is in response to a petition filed by
Sequa Chemicals, Inc.
DATES: Effective July 17, 1996; written objections and requests for a
hearing by August 16, 1996.
ADDRESSES: Submit written objections to the Dockets Management Branch
(HFA-305), Food and Drug Administration, 12420 Parklawn Dr., rm. 1-23,
Rockville, MD 20857.
FOR FURTHER INFORMATION CONTACT: Vir D. Anand, Center for Food Safety
and Applied Nutrition (HFS-216), Food and Drug Administration, 200 C
St. SW., Washington, DC 20204, 202-418-3081.
SUPPLEMENTARY INFORMATION: In a notice published in the Federal
Register of March 8, 1996 (61 FR 9462), FDA announced that a food
additive petition (FAP 6B4497) had been filed by Sequa Chemicals, Inc.,
One Sequa Dr., Chester, SC 29706-0070. The petition proposed to amend
the food additive regulations in Sec. 176.170 Components of paper and
paperboard in contact with aqueous and fatty foods (21 CFR 176.170) to
provide for the safe use of ammonium zirconium lactate-citrate
complexes for use as insolubilizers with protein binders in coatings
for paper and paperboard intended for food-contact applications.
FDA has evaluated the data in the petition and other relevant
material and concludes that the proposed use of the additive in paper
and paperboard products in contact with food is safe. Based on this
information, the agency has also concluded that the additive will have
the intended technical effect. Therefore, Sec. 176.170 should be
amended as set forth below.
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 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 August 16, 1996, 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 176
Food additives, Food packaging.
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 176 is amended as follows:
PART 176--INDIRECT FOOD ADDITIVES: PAPER AND PAPERBOARD COMPONENTS
1. The authority citation for 21 CFR part 176 continues to read as
follows:
Authority: Secs. 201, 402, 406, 409, 721 of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 321, 342, 346, 348, 379e).
2. Section 176.170 is amended in the table in paragraph (a)(5) by
revising the entry for ``Ammonium zirconium citrate (CAS Reg. No.
149564-62-5)'' to read as follows:
Sec. 176.170 Components of paper and paperboard in contact with
aqueous and fatty foods.
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(a) * * *
(5) * * *
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List of substances Limitations
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* * * * * *
*
Ammonium zirconium citrate (CAS Reg. No 149564-62-5), For use as insolubilizers with protein binders in
ammonium zirconium lactate-citrate (CAS Reg. No. coatings for paper and paperboard, at a level not to
149564-64-7), ammonium zirconium lactate (CAS Reg. No. exceed 1.4 percent by weight of coating solids.
149564-63-6).
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*
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[[Page 37210]]
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Dated: June 28, 1996.
Fred R. Shank,
Director, Center for Food Safety and Applied Nutrition.
[FR Doc. 96-18072 Filed 7-16-96; 8:45 am]
BILLING CODE 4160-01-F