[Federal Register Volume 64, Number 100 (Tuesday, May 25, 1999)]
[Rules and Regulations]
[Pages 28097-28098]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-13093]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 177
[Docket No. 92F-0368]
Indirect Food Additives: Polymers
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 a grafted copolymer
of cross-linked sodium polyacrylate with polyvinyl alcohol for use as a
fluid absorbent in food-contact material. This action responds to a
petition filed by Stockhausen, Inc.
DATES: The regulation is effective May 25, 1999; written objections and
requests for a hearing by June 24, 1999.
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: Hortense S. Macon, Food and Drug
Administration, Center for Food Safety and Applied Nutrition (HFS-206),
200 C St. SW., Washington, DC 20204, 202-418-3086.
SUPPLEMENTARY INFORMATION: In a notice published in the Federal
Register of October 28, 1992 (57 FR 48803), FDA announced that a food
additive petition (FAP 2B4323) had been filed by Stockhausen, Inc.,
2408 Doyle St., Greensboro, NC 27406. The petition proposed to amend
the food additive regulations to provide for the safe use of cross-
linked sodium polyacrylate and/or a grafted copolymer of cross-linked
sodium polyacrylate with vinyl alcohol for use as a fluid absorbent in
food-contact material.
The original petition sought approval of several formulations of
the additive and the use of the additive as a fluid absorbent in food-
contact materials used in the packaging of fruit, meat, poultry, and
vegetables. In a subsequent submission to the agency, the petitioner
requested that approval of the additive be limited to its use as a
fluid absorbent in food-contact materials used in the packaging of
poultry. The petitioner also amended its request to seek approval for
only the grafted copolymer of cross-linked sodium polyacrylate. In
addition, the petitioner provided a more detailed description of the
manufacturing of the additive copolymer, which also provided a more
accurate name for the additive, ``grafted copolymer of cross-linked
sodium polyacrylate with polyvinyl alcohol.'' Therefore, this
regulation is limited to the grafted copolymer of cross-linked sodium
polyacrylate intended for use as a fluid absorbent in food-contact
materials used in the packaging of poultry.
FDA has evaluated data in the petition and other relevant material.
Based on this information, the agency concludes that: (1) The proposed
use of the additive is safe, (2) the additive can achieve its intended
technical effect, and therefore, (3) the regulations in 21 CFR part 177
should be amended as set forth below in this document.
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
[[Page 28098]]
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.
This final rule contains no collection of information. Therefore,
clearance by the Office of Management and Budget under the Paperwork
Reduction Act of 1995 is not required.
Any person who will be adversely affected by this regulation may at
any time on or before June 24, 1999, 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 177
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 177 is amended as follows:
PART 177--INDIRECT FOOD ADDITIVES: POLYMERS
1. The authority citation for 21 CFR part 177 continues to read as
follows:
Authority: 21 U.S.C. 321, 342, 348, 379e.
2. Section 177.1211 is added to subpart B to read as follows:
Sec. 177.1211 Cross-linked polyacrylate copolymers.
Cross-linked polyacrylate copolymers identified in paragraph (a) of
this section may be safely used as articles or components of articles
intended for use in contact with food in accordance with the following
prescribed conditions:
(a) Identity. For the purpose of this section, the cross-linked
polyacrylate copolymers consist of the grafted copolymer of cross-
linked sodium polyacrylate identified as 2-propenoic acid, polymers
with N,N-di-2-propenyl-2-propen-1-amine and hydrolyzed polyvinyl
acetate, sodium salts, graft (CAS Reg. No. 166164-74-5).
(b) Adjuvants. The copolymers identified in paragraph (a) of this
section may contain optional adjuvant substances required in the
production of such copolymers. The optional adjuvant substances may
include substances permitted for such use by regulations in parts 170
through 179 of this chapter, substances generally recognized as safe in
food, and substances used in accordance with a prior sanction or
approval.
(c) Extractives limitations. The copolymers identified in paragraph
(a) of this section, in the finished form in which they will contact
food, must yield low molecular weight (less than 1,000 Daltons)
extractives of no more than 0.15 percent by weight of the total polymer
when extracted with 0.2 percent by weight of aqueous sodium chloride
solution at 20 deg.C for 24 hours. The low molecular weight
extractives shall be determined using size exclusion chromatography or
an equivalent method. When conducting the extraction test, the
copolymer, with no other absorptive media, shall be confined either in
a finished absorbent pad or in any suitable flexible porous article,
(such as a ``tea bag'' or infuser), under an applied pressure of 0.15
pounds per square inch (for example, a 4x6 inch square pad is subjected
to a 1.6 kilograms applied mass). The solvent used shall be 60
milliliters aqueous sodium chloride solution per gram of copolymer.
(d) Conditions of use. The copolymers identified in paragraph (a)
of this section are limited to use as a fluid absorbent in food-contact
materials used in the packaging of frozen or refrigerated poultry.
Dated: May 17, 1999.
L. Robert Lake,
Director, Office of Policy, Planning and Strategic Initiatives, Center
for Food Safety and Applied Nutrition.
[FR Doc. 99-13093 Filed 5-24-99; 8:45 am]
BILLING CODE 4160-01-F