[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) * * *

[[Page 47109]]



 
------------------------------------------------------------------------
                                                 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
------------------------------------------------------------------------
  *                  *                  *                  *
                   *                  *                  *
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) * * *

 
------------------------------------------------------------------------
          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.
------------------------------------------------------------------------

* * * * *

    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