[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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