[Federal Register: December 23, 1998 (Volume 63, Number 246)]
[Rules and Regulations]
[Page 71016-71018]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr23de98-9]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 175

[Docket No. 92F-0443]

Indirect Food Additives: Adhesives and Components of Coatings

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
dimethylpolysiloxane coatings produced by cross-linking a vinyl-
containing dimethylpolysiloxane with methylhydrogen polysiloxane and
dimethylmethylhydrogen polysiloxane using a platinum catalyst. FDA is
also amending the food additive regulations to provide for the safe use
of 3,5-dimethyl-1-hexyne-3-ol, 1-ethynylcyclohexene,
bis(methoxymethyl)ethyl maleate, methylvinyl cyclosiloxane, and
tetramethyltetravinylcyclotetrasiloxane as optional polymerization
inhibitors. This action is in partial response to a petition filed by
Dow Corning Corp.

DATES: The regulation is effective December 23, 1998; written
objections and requests for a hearing by January 22, 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: Julius Smith, Center for Food Safety
and Applied Nutrition (HFS-215), Food and Drug Administration, 200 C
St. SW., Washington, DC 20204, 202-418-3091.

SUPPLEMENTARY INFORMATION: In a notice published in the Federal
Register of February 12, 1993 (58 FR 8290), FDA announced that a
petition (FAP 3B4346) had been filed by Dow Corning Corp., P.O. Box
994, Midland, MI 48686-0994. The petition proposed to amend the food
additive regulations in Sec. 175.300 Resinous and polymeric coatings
(21 CFR 175.300), Sec. 175.320 Resinous and polymeric coatings for
polyolefin films (21 CFR 175.320), and 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 dimethylpolysiloxane coatings produced
by cross-linking a vinyl-containing dimethylpolysiloxane with
methylhydrogen-containing polysiloxane and dimethylmethylhydrogen
polysiloxane polymers using a platinum catalyst. The petition further
proposed that the food additive regulations be amended to provide for
the safe use 3,5-dimethyl-1-hexyne-3-ol, 1-ethynylcyclohexene,
bis(methoxymethyl)ethyl maleate and methylvinyl cyclosiloxane as
optional polymerization inhibitors. Additionally, the petition proposed
that the regulations be amended to provide for the safe use of 5-
chloro-2-methyl-4-isothiazolin-3-one and 2-methyl-4-isothiazolin-3-one
mixture, optionally containing magnesium nitrate, as an antimicrobial
agent for emulsion-based silicone coating formulations.
    Subsequent to the filing of the petition, the petitioner requested
that tetramethyltetravinylcyclotetrasiloxane be included in the
petition. Therefore, in a notice published in the Federal Register of
July 2, 1998 (63 FR 36246), FDA announced that it was amending the
filing notice of February 12, 1993, to indicate that the petitioner was
also proposing that the food additive regulations be amended to provide
for the safe use of tetramethyltetravinylcyclotetrasiloxane as an
optional polymerization inhibitor in the manufacture of
dimethylpolysiloxane coatings produced by cross-linking a vinyl-
containing dimethylpolysiloxane with methylhydrogen-containing
polysiloxane and dimethylmethylhydrogen polysiloxane polymers using a
platinum catalyst.
    In 1996, Congress enacted the Food Quality Protection Act (the
FQPA). As a result of certain changes made by that law, antimicrobial
formulations used in or on food contact articles were made subject to
regulation as pesticide chemicals by the U.S. Environmental Protection
Agency. Thus, after the FQPA, the proposed use of 5-chloro-2-methyl-4-
isothiazolin-3-one and 2-methyl-4-isothiazolin-3-one mixture, with
magnesium nitrate as an optional ingredient, intended for use as an
antimicrobial agent for emulsion-based silicone coating formulations
was no longer under the jurisdiction of FDA. Because FDA lacked the
authority to regulate this substance for the antimicrobial use, the
agency did not complete its review of the safety of this additive.
    Congress recently passed the Antimicrobial Regulation Technical
Corrections Act of 1998 (the ARTCA) (Pub. L. 105-324) that reverses
some of the jurisdictional changes made by the FQPA. As a result of the
ARTCA, the antimicrobial use of 5-chloro-2-methyl-4-isothiazolin-3-one
and 2-methyl-4-isothiazolin-3-one mixture, with magnesium nitrate as an
optional ingredient, is once again subject to regulation by FDA as a
food additive. The safety of the proposed use of this substance will be
considered by FDA and the agency's decision announced in a subsequent
issue of the Federal Register.
    As noted, the petition proposed to amend Sec. 176.170, however,
because the petitioned additives will be listed under
Sec. 175.300(b)(3) they may, by cross-reference, be used under
Sec. 176.170(b)(2). Therefore, this action does not include an
amendment that would establish a

[[Page 71017]]

separate listing for the additives under Sec. 176.170(b)(2).
    FDA has evaluated the data in the petition and other relevant
material. Based on this information, the agency concludes that the
proposed use of each additive is safe, that each additive will have its
intended technical effect, and therefore, that the regulations in
Secs. 175.300 and 175.320 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 previously considered the environmental effects of
this action as announced in the amended notice of filing for FAP 3B4346
published in the Federal Register of July 2, 1998 (63 FR 36246). No new
information or comments have been received that would affect the
agency's previous determination that there is no significant impact on
the human environment and that an environmental impact statement is not
required.
    This final rule contains no collection 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 22, 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 175

    Adhesives, 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 175 is amended as follows:

PART 175--INDIRECT FOOD ADDITIVES: ADHESIVES AND COMPONENTS OF
COATINGS

    1. The authority citation for 21 CFR part 175 continues to read as
follows:

    Authority: 21 U.S.C. 321, 342, 348, 379e.

    2. Section 175.300 is amended in paragraph (b)(3)(xxviii)(a) by
alphabetically adding an entry to read as follows:

Sec. 175.300  Resinous and polymeric coatings.

* * * * *
    (b) * * *
    (3) * * *
    (xxviii) * * *
    (a) * * *
Siloxane resins originating from the platinum-catalyzed reaction
product of vinyl-containing dimethylpolysiloxane (CAS Reg. No.
68083-18-1 and CAS Reg. No. 68083-19-2) with methylhydrogen
polysiloxane (CAS Reg. No. 63148-57-2) and dimethylmethylhydrogen
polysiloxane (CAS Reg. No. 68037-59-2), where the platinum content
does not exceed 150 parts per million. The following substances may
be used as optional polymerization inhibitors:
3,5-Dimethyl-1-hexyne-3-ol (CAS Reg. No. 107-54-0), at a level not
to exceed 0.53 weight-percent;
1-Ethynylcyclohexene (CAS Reg. No. 931-49-7), at a level not to
exceed 0.64 weight-percent;
Bis(methoxymethyl)ethyl maleate (CAS Reg. No. 102054-10-4), at a
level not to exceed 1.0 weight-percent;
Methylvinyl cyclosiloxane (CAS Reg. No. 68082-23-5); and
Tetramethyltetravinylcyclotetrasiloxane (CAS Reg. No. 2554-06-5).
* * * * *
    3. Section 175.320 is amended in the table in paragraph (b)(3) in
item (i) by alphabetically adding an entry under the headings ``List of
substances'' and ``Limitations'' to read as follows:

Sec. 175.320  Resinous and polymeric coatings for polyolefin films.

    (b) * * *
    (3) * * *

------------------------------------------------------------------------
         List of substances                      Limitations
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(i) * * *
  Siloxanes and silicones: platinum- Platinum content not to exceed 150
   catalyzed reaction product of      parts per million.
   vinyl-containing
   dimethylpolysiloxane (CAS Reg.
   No. 68083-18-1 and CAS Reg. No.
   68083-19-2) with methylhydrogen
   polysiloxane (CAS Reg. No. 63148-
   57-2) and dimethylmethylhydrogen
   polysiloxane (CAS Reg. No. 68037-
   59-2). The following substances
   may be used as optional
   polymerization inhibitors:
    3,5-Dimethyl-1-hexyne-3-ol (CAS
     Reg. No. 107-54-0), at a level
     not to exceed 0.53 weight
     percent;
    1-Ethynylcyclohexene (CAS Reg.
     No. 931-49-7), at a level not
     to exceed 0.64 weight percent;
    Bis(methoxymethyl)ethyl maleate
     (CAS Reg. No. 102054-10-4), at
     a level not to exceed 1.0
     weight percent;
    Methylvinyl cyclosiloxane (CAS
     Reg. No. 68082-23-5); and
    Tetramethyltetravinylcyclotetra
     siloxane (CAS Reg. No. 2554-06-
     5).
  *                    *                    *                    *
                   *                    *                    *
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[[Page 71018]]

* * * * *

    Dated: December 14, 1998.
L. Robert Lake,
Director, Office of Policy, Planning and Strategic Initiatives, Center
for Food Safety and Applied Nutrition.
[FR Doc. 98-33914 Filed 12-22-98; 8:45 am]
BILLING CODE 4160-01-F