[Federal Register Volume 60, Number 161 (Monday, August 21, 1995)]
[Rules and Regulations]
[Pages 43370-43371]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-20606]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 178

[Docket No. 93F-0101]


Indirect Food Additives: Adjuvants, Production Aids, and 
Sanitizers

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 monomethyltin/
dimethyltin isooctylmercaptoacetates as a stabilizer in rigid polyvinyl 
chloride and rigid vinyl chloride copolymers for use in contact with 
food. This action is in response to a petition filed by Morton 
International, Inc.

DATES: Effective August 21, 1995; written objections and requests for a 
hearing by September 20, 1995.

ADDRESSES: Submit written objections to the Dockets Management Branch 
(HFA-305), Food and Drug Administration, rm. 1-23, 12420 Parklawn Dr., 
Rockville, MD 20857.

FOR FURTHER INFORMATION CONTACT: Diane E. Robertson, Center for Food 
Safety and Applied Nutrition (HFS-216), 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 April 22, 1993 (58 FR 21583), FDA announced that a food 
additive petition (FAP 3B4366) had been filed by Morton International, 
Inc., 2000 West St., Cincinnati, OH 45215. The petition proposed to 
amend the food additive regulations in Sec. 178.2010 Antioxidants and/
or stabilizers for polymers (21 CFR 178.2010) to provide for the safe 
use of monomethyltin/dimethyltin isooctylmercaptoacetates as a 
stabilizer in rigid polyvinyl chloride and rigid vinyl chloride 
copolymers in contact with food of Types I, II, III, IV (except liquid 
milk), V, VI, VII, VIII, and IX, described in Table 1 of 
Sec. 176.170(c) (21 CFR 176.170(c)), under conditions of use C through 
G, described in Table 2 of Sec. 176.170(c), and having the following 
specifications: 5 to 90 percent by weight of monomethyltin 
tris(isooctylmercaptoacetate); 10 to 95 percent by weight of 
dimethyltin bis(isooctylmercaptoacetate); no more than 0.2 percent by 
weight of trimethyltin isooctylmercaptoacetate; tin content in the 
range of 15 to 21 percent; and mercaptosulfur content in the range of 
11.5 to 12.8 percent.
    FDA has evaluated the data and information in the petition and 
finds that the isooctylmercaptoacetate components of the additive may 
consist of a mixture of isooctylmercaptoacetates or primarily 2-
ethylhexylmercaptoacetate, an isomer of isooctylmercaptoacetate. 
Therefore, the agency concludes that the additive should be identified 
as containing either ``isooctyl'' or ``2-ethylhexyl'' mercaptoacetates. 
The resulting regulation includes Chemical Abstracts Registry Numbers 
(CAS Reg. Nos.) for both isomers. The agency also finds that, because 
of differing manufacturing methods and test results, tested 
mercaptosulfur content will vary from 11 to 13.5 percent, and that 
allowing this slight additional variation will have no effect on the 
safety of the additive. The agency has also determined that it is not 
necessary to lower the percentage of trimethyltin 
isooctylmercaptoacetate from 0.4 percent by weight to 0.2 percent by 
weight to ensure the safe use of the additive and that the data 
submitted support the use of the additive under condition of use C in 
Sec. 176.170(c) Table 2 with a maximum temperature of 88  deg.C (190 
deg.F). With these modifications, FDA concludes that the proposed use 
of monomethyltin/dimethyltin isooctylmercaptoacetates is safe and that 
Sec. 178.2010 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 21 CFR 
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.
    Any person who will be adversely affected by this regulation may at 
any time on or before September 20, 1995, 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 178

    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 178 is amended as follows:

PART 178--INDIRECT FOOD ADDITIVES: ADJUVANTS, PRODUCTION AIDS, AND 
SANITIZERS

    1. The authority citation for 21 CFR part 178 continues to read as 
follows:


[[Page 43371]]

    Authority: Secs. 201, 402, 409, 721 of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 321, 342, 348, 379e).
    2. Section 178.2010 is amended in the table in paragraph (b) by 
revising the entry ``Dimethyltin/monomethyltin 
isooctylmercaptoacetates'' under the headings ``Substances'' and 
``Limitations'' to read as follows:

Sec. 178.2010  Antioxidants and/or stabilizers for polymers.

* * * * *
    (b) * * *

                                                                        
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             Substances                          Limitations            
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  *                    *                    *                    *      
                   *                    *                    *          
Dimethyltin/monomethyltin            For use only at levels not to      
 isooctylmercaptoacetates             exceed 2 percent by weight:       
 consisting of 5 to 90 percent by    1. In rigid polyvinyl chloride used
 weight of monomethyltin tris         in the manufacture of pipes       
 (isooctylmercaptoacetate) (CAS       intended for contact with water in
 Reg. No. 54849-38-6) or              food-processing plants, and       
 monomethyltin tris(2-               2. In rigid polyvinyl chloride and 
 ethylhexylmercaptoacetate) (CAS      in rigid vinyl chloride copolymers
 Reg. No. 57583-34-3) and 10 to 95    complying with Sec.  177.1950 of  
 percent by weight of dimethyltin     this chapter or Sec.  177.1980 of 
 bis (isooctylmercaptoacetate) (CAS   this chapter for use in contact   
 Reg. No. 26636-01-1) or              with food of Types I, II, III, IV 
 dimethyltin bis(2-                   (except liquid milk), V, VI, VII, 
 ethylhexylmercaptoacetate) (CAS      VIII, and IX described in Table 1 
 Reg. No. 57583-35-43), and no more   of Sec.  176.170(c) of this       
 than 0.4 percent by weight of        chapter under conditions of use C 
 trimethyltin compounds, and having   through G described in Table 2 of 
 the following specifications: Tin    Sec.  176.170(c) of this chapter  
 content (as Sn) in the range of 15   at temperatures not to exceed 88  
 to 21 percent and mercaptosulfur     deg.C (190  deg.F).               
 content in the range of 11 to 13.5                                     
 percent. Other alkyltin compounds                                      
 are not to exceed 20 ppm.                                              
  *                    *                    *                    *      
                   *                    *                    *          
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    Dated: August 1, 1995.
Fred R. Shank,
Director, Center for Food Safety and Applied Nutrition.
[FR Doc. 95-20606 Filed 8-18-95; 8:45 am]
BILLING CODE 4160-01-F