[Federal Register Volume 63, Number 246 (Wednesday, December 23, 1998)]
[Rules and Regulations]
[Pages 71016-71018]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-33914]


-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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
------------------------------------------------------------------------
(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).
  *                    *                    *                    *
                   *                    *                    *
------------------------------------------------------------------------


[[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