[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
