[Federal Register Volume 63, Number 242 (Thursday, December 17, 1998)]
[Rules and Regulations]
[Pages 69550-69551]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-33454]
[[Page 69550]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 176
[Docket No. 95F-0255]
Indirect Food Additives: Paper and Paperboard Components
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 diallyl maleate and
1-ethynyl-1-cyclohexanol as optional polymerization inhibitors and
dimethyl (methyl hydrogen) polysiloxane as a cross-linking agent in the
manufacture of vinyl-containing siloxanes that are used in coatings for
paper and paperboard that contact food; to increase the maximum
permitted residual level of platinum, which remains from the catalyst
used in the manufacture of vinyl-containing siloxanes, to 200 parts per
million (ppm) of these siloxanes; and to expand the safe use of
coatings with vinyl-containing siloxanes for contact with additional
food types and under additional conditions of use. This action is in
response to a petition filed by GE Silicones.
DATES: The regulation is effective December 17, 1998; written
objections and requests for a hearing by January 19, 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: Ellen M. Waldron, Center for Food
Safety and Applied Nutrition (HFS-215), Food and Drug Administration,
200 C St. SW., Washington, DC 20204, 202-418-3089.
SUPPLEMENTARY INFORMATION: In a notice published in the Federal
Register of September 25, 1995 (60 FR 49414), FDA announced that a food
additive petition (FAP 5B4475) had been filed by GE Silicones, c/o 700
13th St. NW., Washington, DC 20005. The petition proposed to amend the
food additive regulations in Sec. 176.170 Components of paper and
paperboard in contact with aqueous and fatty foods (21 CFR 176.170) to
provide for the safe use of vinyl-containing siloxanes as a component
of coatings for paper and paperboard in contact with food and to
provide for the safe use of 1-ethynyl-1-cyclohexanol as an optional
inhibitor for the additive. The petition also proposed that the
regulations be amended to increase the level of platinum catalyst used
in the manufacture of vinyl-containing siloxanes to 200 ppm. In a
notice published in the Federal Register of September 5, 1996 (61 FR
46814), FDA amended the September 25, 1995, notice to indicate that
upon further review of the petition, the agency noted that the
petitioner also proposed approval of the use of diallyl maleate as an
optional polymerization inhibitor and dimethyl (methyl hydrogen)
polysiloxane as a cross-linking agent in the manufacture of vinyl-
containing siloxanes used in coatings on paper and paperboard that
contact food. In addition, the agency clarified that the petitioner
proposed to expand the safe use of coatings with vinyl-containing
siloxanes for contact with additional food types and under additional
conditions of use.
In the filing notices, the agency inadvertently stated that the
petition proposed to increase the level of platinum catalyst used in
the manufacture of vinyl-containing siloxanes. The petition actually
proposed to increase the maximum permitted residual level of platinum
in the vinyl-containing siloxanes, which is consistent with the
existing regulation.
FDA has evaluated the data in the petition and other relevant
material. The agency finds that the proposed use of the additives
diallyl maleate and 1-ethynyl-1-cyclohexanol as optional polymerization
inhibitors and the proposed use of the additive dimethyl (methyl
hydrogen) polysiloxane as a cross-linking agent in the manufacture of
vinyl-containing siloxanes intended for use as a component of coatings
for paper and paperboard in contact with food are safe and achieve
their intended technical effects. Finally, the agency concludes that
the resulting vinyl-containing siloxanes are safe and will have their
intended technical effects. Therefore, the regulations in Sec. 176.170
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 person 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 January 19, 1999, 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.
List of Subjects in 21 CFR Part 176
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 176 is amended as follows:
[[Page 69551]]
PART 176--INDIRECT FOOD ADDITIVES: PAPER AND PAPERBOARD COMPONENTS
1. The authority citation for 21 CFR part 176 continues to read as
follows:
Authority: 21 U.S.C. 321, 342, 346, 348, 379e.
2. Section 176.170 is amended in the table in paragraph (b)(2) by
revising the first entry for ``Siloxanes and silicones'' under the
headings ``List of substances'' and ``Limitations'' to read as follows:
Sec. 176.170 Components of paper and paperboard in contact with
aqueous and fatty foods.
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(b) * * *
(2) * * *
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List of substances Limitations
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Siloxanes and silicones; platinum-catalyzed reaction For use only as a surface coating. Platinum content not
product of vinyl-containing dimethyl polysiloxane (CAS to exceed 200 parts per million.
Reg. Nos. 68083-19-2 and 68083-18-1) with methyl
hydrogen polysiloxane (CAS Reg. No. 63148-57-2) or
dimethyl (methyl hydrogen) polysiloxane (CAS Reg. No.
68037-59-2). Diallyl maleate (CAS Reg No. 999-21-3),
dimethyl maleate (CAS Reg. No. 624-48-6), 1-ethynyl-1-
cyclohexanol (CAS Reg. No. 78-27-3) and vinyl acetate
(CAS Reg. No. 108-05-4) may be used as optional
polymerization inhibitors.
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Dated: December 4, 1998.
L. Robert Lake,
Director, Office of Policy, Planning and Strategic Initiatives, Center
for Food Safety and Applied Nutrition.
[FR Doc. 98-33454 Filed 12-16-98; 8:45 am]
BILLING CODE 4160-01-F