[Federal Register Volume 64, Number 167 (Monday, August 30, 1999)]
[Rules and Regulations]
[Pages 47107-47109]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-22474]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 177
[Docket No. 89F-0338]
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 fumaric acid
grafted onto certain olefin polymers, and maleic anhydride grafted onto
ethylene-vinyl acetate copolymers for use in contact with food. This
action is in response to a petition filed by E. I du Pont de Nemours
and Co.
DATES: This regulation is effective August 30, 1999; submit written
objections and requests for a hearing September 29, 1999. 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
certain publications in Sec. 177.1350 (b)(2), effective August 30,
1999.
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: 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 August 31, 1989 (54 FR 36053), FDA announced that a food
additive petition (FAP 9B4163) had been filed by E. I. du Pont de
Nemours and Co., 1007 Market St., Wilmington, DE 19898 (presently, c/o
Keller and Heckman, 1001 G St. NW., suite 500 West, Washington, DC
20001). The petition proposed to amend the food additive regulations in
Sec. 177.1350 Ethylene-vinyl acetate copolymers (21 CFR 177.1350) and
Sec. 177.1520 Olefin polymers (21 CFR 177.1520) to provide for the safe
use of fumaric acid and maleic anhydride grafted onto certain olefin
polymers and maleic anhydride grafted onto ethylene-vinyl acetate
copolymers for use in contact with food. In a subsequent submission,
the petitioner withdrew its request for the proposed use of maleic
anhydride grafted onto olefin polymers. In this final rule the agency
is, therefore, providing for the use of only fumaric acid grafted onto
olefin polymers.
FDA has evaluated data in the petition and other relevant
material. Based on this information, the agency concludes that the
proposed use of the additives is safe, that the additives will achieve
their intended technical effects, and therefore, that the regulations
in Secs. 177.1350 and 177.1520 should be amended as set forth in this
document.
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 previously. 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.
The agency has determined under 21 CFR 25.31(i) that this action
is of a type that does not individually or cumulatively have a
significant effect on the human environment. Therefore, neither an
environmental assessment nor an environmental impact statement is
required.
Any person who will be adversely affected by this regulation may
at any time on or before September 29, 1999 file with the Dockets
Management Branch (address above) written objection thereto. Each
objection shall
[[Page 47108]]
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
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 objection 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 177.1350 is amended by redesignating paragraph (a)
introductory text and paragraphs (a)(1) through (a)(6) as paragraphs
(a)(1) introductory text and (a)(1)(i) through (a)(1)(vi),
respectively, and by redesignating paragraph (b) as paragraph (b)(1),
and by adding paragraphs (a)(2) and (b)(2) to read as follows:
Sec. 177.1350 Ethylene-vinyl acetate copolymers.
* * * * *
(a)(1) * * *
(2) Maleic anhydride-grafted ethylene-vinyl acetate copolymers
(CAS Reg. No. 28064-24-6) consist of basic resins produced by the
catalytic copolymerization of ethylene and vinyl acetate, followed by
reaction with maleic anhydride. Such polymers shall contain not more
than 11 percent of polymer units derived from vinyl acetate by weight
of total polymer prior to reaction with maleic anhydride, and not more
than 2 percent of grafted maleic anhydride by weight of the finished
polymer. Optional adjuvant substances that may be added to the
copolymers include substances generally recognized as safe in food and
food packaging, substances the use of which is permitted under
applicable regulations in parts 170 through 189 of this chapter, and
substances identified in Sec. 175.300(b)(3)(xxv), (xxvii), (xxxiii),
and (xxx) of this chapter and colorants for polymers used in accordance
with the provisions of Sec. 178.3297 of this chapter.
(b)(1) * * *
(2) Maleic anhydride grafted ethylene-vinyl acetate copolymers
shall have a melt flow index not to exceed 2.1 grams per 10 minutes as
determined by ASTM method D 1238-82, ``Standard Test Method for Flow
Rates of Thermoplastics by Extrusion Plastometer,'' which is
incorporated by reference in accordance with 5 U.S.C. 552(a). Copies
may be obtained from the American Society for Testing Materials, 1916
Race St., Philadelphia, PA 19103, or at the Division of Petition
Control (HFS-215), 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.
Compliance of the melt flow index specification shall be determined
using conditions and procedures corresponding to those described in the
method as Condition E, Procedure A). The copolymers shall be used in
blends with other polymers at levels not to exceed 17 percent by weight
of total polymer, subject to the limitation that when contacting food
of types III, IV-A, V, VI-C, VII-A, and IX, identified in
Sec. 176.170(c) of this chapter, Table 1, the polymers shall be used
only under conditions of use C, D, E, F, and G, described in
Sec. 176.170(c) of this chapter, Table 2.
* * * * *
3. Section 177.1520 is amended by redesignating paragraph (a)(2)
as paragraph (a)(2)(i), by adding paragraphs (a)(2)(ii) and (a)(3)(vi),
by amending paragraph (c) in the table by adding items 2.4 and 3.8 in
numerical order, and by amending paragraph (d)(7) in the table by
alphabetically adding two entries to read as follows:
Sec. 177.1520 Olefin polymers.
* * * * *
(a) * * *
(2)(i) * * *
(ii) Fumaric acid-grafted polyethylene (CAS Reg. No. 26877-81-6)
consists of basic polymers manufactured by the catalytic polymerization
of ethylene followed by reaction with fumaric acid in the absence of
free radical initiators. Such polymers shall contain grafted fumaric
acid at levels not to exceed 2 percent by weight of the finished
polymer.
(3) * * *
(vi) Olefin basic copolymers (CAS Reg. No. 61615-63-2) manufactured
by the catalytic copolymerization of ethylene and propylene with 1,4-
hexadiene, followed by reaction with fumaric acid in the absence of
free radical initiators. Such polymers shall contain not more than 4.5
percent of polymer units deriving from 1,4-hexadiene by weight of total
polymer prior to reaction with fumaric acid and not more than 2.2
percent of grafted fumaric acid by weight of the finished polymer.
* * * * *
(c) * * *
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Maximum Maximum
extractable soluble
Melting fraction fraction
point (MP) (expressed (expressed
or as percent as percent
Olefin polymers Density softening by weight of by weight of
point (SP) the polymer) polymer) in
(Degrees in N-hexane xylene at
Centigrade) at specified specified
temperatures temperatures
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* * * *
* * *
2.4 Olefin polymers
described in
paragraph (a)(2)(ii)
of this section,
having a melt flow
index not to exceed
17 grams/per 10
minutes as
determined by the
method described in
paragraph (d)(7) of
this section, for
use in blends with
other polymers at
levels not to exceed
20 percent by weight
of total polymer,
subject to the
limitation that when
contacting food of
types III, IV-A, V,
VI-C, VII-A, and IX
identified in Sec.
176.170(c) of this
chapter, Table 1,
the polymers shall
be used only under
conditions of use C,
D, E, F, and G,
described in Sec.
176.170(c) of this
chapter, Table 2.
* * * *
* * *
3.8 Olefin polymers
described in
paragraph (a)(3)(vi)
of this section,
having a melt flow
index not to exceed
9.2 grams per 10
minutes as
determined by the
method described in
paragraph (d)(7) of
this section, for
use in blends with
other polymers at
levels not to exceed
8 percent by weight
of total polymer,
subject to the
limitation that when
contacting food of
types III, IV-A, V,
VI-C, VII-A, and IX,
identified in Sec.
176.170(c) of this
chapter, Table 1,
the polymers shall
be used only under
conditions of use C,
D, E, F, and G,
described in Sec.
176.170(c) of this
chapter, Table 2.
* * * *
* * *
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(d) * * *
(7) * * *
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List of polymers Conditions/procedures
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* * * * *
Olefin polymers described in Condition E, procedure A.
paragraph (a)(2)(ii) of this
section.
Olefin polymers described in Condition E, procedure A.
paragraph (a)(3)(vi) of this
section.
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* * * * *
Dated: August 5, 1999.
Janice F. Oliver,
Deputy Director, Center for Food Safety and Applied Nutrition.
[FR Doc. 99-22474 Filed 8-27-99; 8:45 am]
BILLING CODE 4160-01-F
