[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]


=======================================================================
-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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