[Federal Register Volume 61, Number 66 (Thursday, April 4, 1996)]
[Rules and Regulations]
[Pages 14964-14966]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-8148]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 177

[Docket No. 88F-0339]


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 poly(oxy-1,2-
ethanediyloxycarbonyl-2,6-naphthalenediylcarbonyl) as the basic resin 
in articles intended for use in contact with food. This action responds 
to a petition filed by the Eastman Chemical Co.

DATES: Effective April 4, 1996; written objections and requests for a 
hearing by May 6, 1996. 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 listed in new 
Sec. 177.1637(b)(2), effective April 4, 1996.

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: Richard H. White, Center for Food 
Safety and Applied Nutrition (HFS-216), Food and Drug Administration, 
200 C St. SW., Washington, DC 20204, 202-418-3094.

SUPPLEMENTARY INFORMATION: In a notice published in the Federal 
Register of October 26, 1988 (53 FR 43272), FDA announced that a food 
additive petition (FAP 8B4110) had been filed by the Eastman Kodak Co., 
Eastman Chemical Division, P.O. Box 511, Kingsport, TN 37662. The 
petition proposed to amend the food additive regulations in part 177 
Indirect Food Additives: Polymers (21 CFR part 177) to provide for the 
safe use of poly(ethylene 2,6-naphthalene dicarboxylate) as a basic 
resin in articles or as a component of articles intended for single use 
or repeated use in contact with food.
    Subsequent to the filing of the petition, the Eastman Kodak Co., 
Eastman Chemical Division, was reorganized to form Eastman Chemical 
Co., an independent corporation. As a result of this reorganization, 
FDA was informed that the Eastman Chemical Co. (same address) was the 
petitioner of record for this food additive petition.
    FDA has evaluated the data in the petition and other relevant 
material. The agency concludes that the proposed use of the resin is 
safe and that the food additive regulations should be amended by adding 
new Sec. 177.1637 as set forth below. The agency has also determined, 
with the petitioner's concurrence, that poly(oxy-1,2-
ethanediyloxycarbonyl-2,6-naphthalenediylcarbonyl) is a more accurate 
and descriptive name for the resin that is the subject of the food 
additive petition. Therefore, FDA is using this name to identify the 
resin in the final rule.
    In its review of this petition, the agency has also carefully 
considered the potential environmental effects of this action. In 
particular, the agency has considered the potential for effects on the 
management of municipal solid waste because this resin may replace 
other materials that are currently recycled. The petitioner provided 
the results of studies demonstrating that the resin can be recycled for 
use in food containers and submitted a recycling implementation plan 
for FDA's review. The agency is convinced that it is feasible for 
packaging made with this resin to be recovered from post-consumer waste 
and recycled, based upon the following factors: (1) The petitioner's 
recycling plan and stated

[[Page 14965]]
intention to recycle containers made with this resin; (2) the desirable 
barrier and heat-resistance properties of the resin (Ref. 1); (3) the 
high economic value of the resin (Ref. 2); and (4) recent steady 
increases in the recycling rates of many containers and packaging, 
which demonstrate that recycling has been accepted by both consumers 
and commercial interests as an important post-consumer waste management 
strategy (Ref. 3). However, the agency was concerned that unless 
articles made with the subject resin were distinctly marked to separate 
them from other plastic containers, the resin would not be recycled and 
might interfere with the recycling of plastic containers made with 
other resins. In response to this concern, the petitioner amended the 
petition to include a requirement that articles made with the resin be 
identified to facilitate collection and sorting.
    The agency's regulation for this resin will contain a requirement 
that the manufacturers of articles made with the resin must mark or 
label these articles so that consumers and sorters will be able to 
recognize the articles easily and quickly as items to be recycled and 
collected separately. This requirement is intended to meet the agency's 
responsibility under section 101(b)(6) of the National Environmental 
Policy Act (42 U.S.C. 4331(b)(6)) to use its functions and programs to 
maximize the recycling of depletable resources. Depletable resources 
include those from which this resin is produced.
    FDA recognizes that the requirement that poly(oxy-1,2-
ethanediyloxycarbonyl-2,6-naphthalenediylcarbonyl) resin be marked for 
recycling may raise a question as to whether the recycled resin may be 
used in contact with food. Currently, FDA reviews recycling processes 
on a case-by-case basis to determine if the process will remove 
potential contaminants and produce a recycled resin that is suitably 
pure for food-contact use. When appropriate, the agency may limit the 
conditions of use of the recycled resin. The manufacturer of the 
recycled resin is notified by letter of the agency's determination 
regarding food-contact use of the recycled resin. In accordance with 
these procedures, FDA has evaluated studies submitted by Eastman 
Chemical Co. regarding its recycling process and is notifying Eastman 
Chemical Co. by letter that its proposed recycling process will produce 
poly(oxy-1,2-ethanediyloxycarbonyl-2,6-napthalenediylcarbonyl) resin 
that is safe for use in contact with food. This determination will not 
require an amendment to the food additive regulations.
    FDA has concluded that this 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.
    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 21 CFR 
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.
    Any person who will be adversely affected by this regulation may at 
any time on or before May 6, 1996, 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.

References

    1. Ainsworth, S. J., ``PET Resins Maintain Strong Growth Despite 
Market Challenges,'' Chemical & Engineering News, pp. 11-12, April 
18, 1994.
    2. Miller, C., ``Saving the World for (From?) PEN,'' Waste Age's 
Recycling Times, vol. 7, No. 19: p. 15, September 19, 1995.
    3. United States Environmental Protection Agency, 
Characterization of Municipal Solid Waste in the United States, 1994 
update, EPA530-R-94-042, November 1994, Table 21, p. 70; document 
available from NTIS at telephone number 703-487-4650 with order 
number: PB 95-147690.

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, 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: Secs. 201, 402, 409, 721 of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 321, 342, 348, 379e).

    2. New Sec. 177.1637 is added to subpart B to read as follows:


Sec. 177.1637  Poly(oxy-1,2-ethanediyloxycarbonyl-2,6-
naphthalenediylcarbonyl) resins.

    Poly(oxy-1,2-ethanediyloxycarbonyl-2,6-naphthalenediylcarbonyl) 
resins 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 conditions:
    (a) Identity. For the purpose of this section, poly(oxy-1,2-
ethanediyloxycarbonyl-2,6-naphthalenediylcarbonyl) resins (CAS Reg. No. 
24968-11-4) are polymers formed by catalytic transesterification of 
2,6-dimethylnaphthalene dicarboxylate with ethylene glycol followed by 
catalytic polycondensation.
    (b) Specifications. (1) Density. The density of poly(oxy-1,2-
ethanediyloxycarbonyl-2,6-naphthalenediylcarbonyl) resins shall be 
between 1.33 and 1.40 grams per cubic centimeter.
    (2) Inherent viscosity. The finished food-contact article shall 
have a minimum inherent viscosity of 0.55 deciliter per gram in a 
solution of 0.1 gram of polymer in 100 milliliters of a 25/40/35 
(weight/weight/weight) solution of p-chlorophenol/tetrachloroethane/
phenol. The viscosity is determined by Eastman Chemical Co.'s method 
ECD-A-AC-G-V-1-5, ``Determination of Dilute Solution Viscosity of 
Polyesters,'' dated May 31, 1988, which is incorporated by reference in 
accordance with 5 U.S.C.

[[Page 14966]]
552(a) and 1 CFR part 51. Copies are available from the Office of 
Premarket Approval, Center for Food Safety and Applied Nutrition (HFS-
215), 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, Food and Drug Administration, 200 C St. SW., rm. 
3321, Washington, DC, or at the Office of the Federal Register, 800 
North Capitol St. NW., Washington, DC.
    (c) Extraction limitations. A 0.5 millimeter (0.02 inch) thick 
sheet of resin when extracted with water at 121  deg.C (250  deg.F) for 
2 hours shall yield total nonvolatile extractives not exceeding 2.0 
micrograms per square inch of exposed resin surface.
    (d) Conditions of use. The finished food contact article shall be:
    (1) Used in contact only with food of Types I, II, IVB, VIA, VIB, 
VIIB, and VIII identified in Table 1 of Sec. 176.170(c) of this 
chapter, under conditions of use A through H described in Table 2 of 
Sec. 176.170(c) of this chapter; and with food of Types III, IVA, V, 
VIC, VIIA, and IX identified in Table 1 of Sec. 176.170(c) of this 
chapter, under conditions of use C through H described in Table 2 of 
Sec. 176.170(c) of this chapter; and
    (2) Identified in a manner that will differentiate the article from 
articles made of other polymeric resins to facilitate collection and 
sorting.

    Dated: March 28, 1996.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 96-8148 Filed 4-3-96; 8:45 am]
BILLING CODE 4160-01-F