[Federal Register Volume 64, Number 99 (Monday, May 24, 1999)]
[Rules and Regulations]
[Pages 27915-27916]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-12962]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 177

[Docket No. 98F-0730]


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 change the density specifications for ethylene-
maleic anhydride copolymers intended for use in contact with food. This 
action is in response to a petition filed by Keller and Heckman LLP.

DATES: The regulation is effective May 24, 1999; written objections and 
requests for a hearing by June 23, 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: Mark A. Hepp, Center for Food Safety 
and Applied Nutrition (HFS-215), Food and Drug Administration, 200 C 
St. SW., Washington, DC 20204, 202-418-3098.

SUPPLEMENTARY INFORMATION: In a notice published in the  Federal 
Register of September 8, 1998 (63 FR 47503), FDA announced that a food 
additive petition (FAP 8B4623) had been filed by Keller and Heckman 
LLP, 1001 G St. NW., suite 500 West, Washington, DC 20001. The petition 
proposed to amend the food additive regulations in Sec. 177.1520 Olefin 
polymers (21 CFR 177.1520), to change the the density specifications 
from ``0.92-0.94'' to ``0.92 or greater'' for ethylene-maleic anhydride 
copolymers intended for use in contact with food.
     The September 8, 1998, filing notice for the petition stated that 
the action resulting from the petition qualified for a categorical 
exclusion under 21 CFR 25.32(i). Upon further review, the agency 
determined that such a categorical exclusion is not appropriate for 
this action because the additive is expected to be present in the 
finished food-contact article at a level greater than 5 percent by 
weight. Consequently, the agency considered the environmental effects 
of this action.
     FDA has evaluated data in the petition and other relevant 
material. Based on this information, the agency has determined that the 
petitioner has adequately demonstrated that ethylene-maleic anhydride 
copolymers with a density specification of ``0.92 or greater'' in place 
of ``0.92-0.94'', conform to the identity and specifications under 
Sec. 177.1520(c), item 6 for ethylene-maleic anhydride copolymers. 
Thus, the agency concludes that the proposed use of the additive is 
safe, that the additive will achieve its intended technical effect, and 
therefore, that the regulations in Sec. 177.1520 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 persons 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 on or before June 23, 1999, file with the Dockets 
Management Branch (address above) written objection 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 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

[[Page 27916]]

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.
     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 177.1520 is amended in the table in paragraph (c) by 
revising item ``6.'' under the heading ``Density'' to read as follows:


Sec. 177.1520   Olefin polymers.

* * * * *
     (c) * * *

 
------------------------------------------------------------------------
                                               Maximum        Maximum
                                             extractable      soluble
                            Melting Point     fraction        fraction
                               (MP) or      (expressed as  (expressed as
                              softening      percent by      percent by
Olefin polymers   Density     point (SP)    weight of the    weight of
                               (Degrees    polymer) in N-   polymer) in
                             Centigrade)      hexane at      xylene at
                                              specified      specified
                                            temperatures    temperatures
------------------------------------------------------------------------
                      *      *      *      *      *
6. Ethylene-     0.92 or                   1.36 pct at 50  2.28 pct at
 maleic           greater                   C.              25 C
 anhydride
 copolymers
 described in
 paragraph
 (a)(6) of this
 section for
 use as the
 adhesive
 component in
 multilaminate
 structures, or
 as the sealant
 layer in
 flexible
 packaging, in
 contact with
 food at
 temperatures
 not exceeding
 49 C (120 F)
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* * * * *
    Dated: May 5, 1999.
L. Robert Lake,
Director, Office of Policy, Planning and Strategic Initiatives, Center 
for Food Safety and Applied Nutrition.
[FR Doc. 99-12962 Filed 5-21-99; 8:45 am]
BILLING CODE 4160-01-F