[Federal Register Volume 65, Number 63 (Friday, March 31, 2000)]
[Rules and Regulations]
[Pages 17134-17135]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-8037]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 177

[Docket No. 94F-0246]


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 ethylene-vinyl 
acetate-vinyl alcohol copolymers with revised specifications that 
provide for a decreased minimum acceptable ethylene content and an 
increased maximum permitted level of migration of ethylene-vinyl 
acetate-vinyl alcohol oligomers for use as articles or components of 
articles intended for contact with food. This action responds to a 
petition filed by Kuraray Co., Ltd.

DATES: This rule is effective March 31, 2000. Submit written objections 
and requests for a hearing by May 1, 2000. The Director of the Office 
of the Federal Register approves the incorporation by reference in 
accordance with 5 U.S.C. 552(a) and 1 CFR part 51 of a certain 
publication in 21 CFR 177.1360(d), as of March 31, 2000.

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: Mitchell A. Cheeseman, Center for Food 
Safety and Applied Nutrition (HFS-215), Food and Drug Administration, 
200 C St. SW., Washington, DC 20204, 202-418-3083.

SUPPLEMENTARY INFORMATION: In a notice published in the Federal 
Register of August 17, 1994 (59 FR 42277), FDA announced that a food 
additive petition (FAP 4B4421) had been filed by Kuraray Co., Ltd., c/o 
1001 G St. NW., suite 500 West, Washington, DC 20001. The petition 
proposed to amend Sec. 177.1360 Ethylene-vinyl acetate-vinyl alcohol 
copolymers (21 CFR 177.1360) of the food additive regulations to 
provide for the safe use of ethylene-vinyl acetate-vinyl alcohol 
copolymers with revised specifications that provide for a decreased 
minimum acceptable ethylene content and an increased maximum permitted 
level of migration of ethylene-vinyl acetate-vinyl alcohol oligomers 
for use as articles or components of articles intended for contact with 
food.
    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 will achieve its intended 
technical effect, and (3) the regulations in Sec. 177.1360 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.
    This final rule contains no collections 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 file with the Dockets Management Branch (address above) 
written objections by May 1, 2000. 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

[[Page 17135]]

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 are to be 
submitted and are to 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, Incorporation by reference.
    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 177.1360 is amended by revising paragraphs (a)(3) and 
(d) to read as follows:


Sec. 177.1360  Ethylene-vinyl acetate-vinyl alcohol copolymers.

* * * * *
    (a) * * *
    (3) Those copolymers containing 17 to 40 percent ethylene and 60 to 
83 percent vinyl alcohol units by weight may be used in contact with 
foods as described in paragraph (d) of this section.
* * * * *
    (d) The finished food-contact article shall not exceed 0.018 
centimeter (0.007 inch) thickness and may contact all foods, except 
those containing more than 8 percent alcohol, under conditions of use B 
through H described in table 2 of Sec. 176.170(c) of this chapter. Film 
samples of 0.018 centimeter (0.007 inch) thickness representing the 
finished articles shall meet the following extractive limitation when 
tested by ASTM method F34-76 (Reapproved 1980), ``Standard Test Methods 
for Liquid Extraction of Flexible Barrier Materials,'' which is 
incorporated by reference. The availability of this incorporation by 
reference is given in paragraph (b) of this section. The film when 
extracted with distilled water at 100  deg.C (212  deg.F) for 30 
minutes yields ethylene-vinyl acetate-vinyl alcohol oligomers not to 
exceed 0.093 milligram per square centimeter (0.6 milligram per square 
inch) of food contact surface as determined by a method entitled 
``Analytical Method of Determining the Amount of EVOH in the 
Extractives Residue of EVOH Film,'' dated March 23, 1987, as developed 
by the Kuraray Co., Ltd., which is incorporated by reference in 
accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies may be 
obtained from the Office of Premarket Approval (HFS-200), Center for 
Food Safety and Applied Nutrition, Food and Drug Administration, 200 C 
St. SW., Washington, DC 20204, or may be examined at the Center for 
Food Safety and Applied Nutrition's Library, 200 C St. SW., rm. 3321, 
Washington, DC, or at the Office of the Federal Register, 800 North 
Capitol St. NW., suite 700, Washington, DC.
* * * * *

    Dated: March 20, 2000.
L. Robert Lake,
Director of Regulations and Policy, Center for Food Safety and Applied 
Nutrition.
[FR Doc. 00-8037 Filed 3-30-00; 8:45 am]
BILLING CODE 4160-01-F