[Federal Register Volume 63, Number 28 (Wednesday, February 11, 1998)]
[Rules and Regulations]
[Page 6854]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-3356]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 177

[Docket No. 97N-0301]


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 for Nylon 6/66 resins to change the melting point 
range from 380-400  deg.F to 380-425  deg.F. This action is in response 
to a petition filed by Ube Industries (America), Inc.

DATES: Effective February 11, 1998; written objections and requests for 
a hearing by March 13, 1998.

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-215), 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 July 21, 1997 (62 FR 39003), FDA announced that a food 
additive petition (FAP 7B4548) had been filed by Ube Industries 
(America), Inc., c/o Center for Regulatory Services, 2347 Paddock Lane, 
Reston, VA 20191. The petition proposed to amend the food additive 
regulations in Sec. 177.1500 Nylon resins (21 CFR 177.1500), for Nylon 
6/66 resins described in the table in paragraph (b), entry 4.2, to 
change the melting point range from 380-400  deg.F to 380-425  deg.F.
    The filing notice for the petition (62 FR 39003) stated that the 
action resulting from the petition qualified for a categorical 
exclusion under previous 21 CFR 25.24(9). This was a misprint and 
should have cited 21 CFR 25.24(a)(9). Upon further review, the agency 
determined that such a categorical exclusion, which is based on a 
technical change in a regulation, is not appropriate for this proposed 
action because the proposed amendment is not simply a technical change. 
Consequently, the agency considered the environmental effects of this 
action.
    FDA has evaluated data in the petition supporting the chemical 
identity of the additive and other relevant material. The agency finds 
that the petitioner has adequately demonstrated that Nylon 6/66 with a 
melting point that includes the range from 400-425  deg.F meets the 
specifications under Sec. 177.1500(b), entry 4.2. Based on this 
information the agency concludes that: (1) The proposed use of the 
additive is safe, (2) the additive will achieve its intended technical 
effect, and that therefore, (3) the regulations in Sec. 177.1500 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 March 13, 1998, 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.


Sec. 177.1500  [Amended]

    2. Section 177.1500 Nylon resins is amended in the table in 
paragraph (b) for entry ``4.2'' under the heading ``Melting point 
(degrees Fahrenheit)'' by removing ``380-400'' and adding in its place 
``380-425''.

    Dated: January 30, 1998.
Janice F. Oliver,
Acting Director, Center for Food Safety and Applied Nutrition.
[FR Doc. 98-3356 Filed 2-10-98; 8:45 am]
BILLING CODE 4160-01-F