[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