[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) * * *
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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
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* * * * *
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