[Federal Register Volume 65, Number 57 (Thursday, March 23, 2000)]
[Rules and Regulations]
[Pages 15545-15547]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-7011]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 178

[Docket No. 94F-0334]


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 methyltin-2-
mercaptoethyloleate sulfide used alone or in combination with several 
optional substances as a heat stabilizer for use in rigid poly(vinyl 
chloride) (PVC) and rigid vinyl chloride copolymers intended for use in 
the manufacture of pipes and pipe fittings that will contact water in 
food processing plants. This action is in response to a petition filed 
by Morton International, Inc.

DATES: This rule is effective March 23, 2000. Submit written objections 
and requests for a hearing by April 24, 2000.

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: Vivian M. Gilliam, Center for Food 
Safety and Applied Nutrition (HFS-215), Food and Drug Administration, 
200 C St. SW., Washington, DC 20204, 202-418-3094.

[[Page 15546]]


SUPPLEMENTARY INFORMATION: In a notice published in the Federal 
Register of October 21, 1994 (59 FR 53193), FDA announced that a food 
additive petition (FAP 4B4430) 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 methyltin-2-mercaptoethyloleate sulfide mixtures as heat 
stabilizers for use in PVC pipes intended for transporting water for 
food contact.
    Subsequent to the filing of the petition, FDA determined that 
methyltin-2-mercaptoethyloleate sulfide is a complex mixture. In 
addition, FDA determined that the petition also proposed that 
methyltin-2-mercaptoethyloleate sulfide may be used in combination with 
certain optional substances. Therefore, in a notice published in the 
Federal Register of September 7, 1999 (64 FR 48655), FDA announced that 
it was amending the filing notice of October 21, 1994, to indicate that 
the petitioner requests that the food additive regulations be amended 
to provide for the safe use of methyltin-2-mercaptoethyloleate sulfide 
as a heat stabilizer for use in rigid PVC and rigid vinyl chloride 
copolymers, complying with Secs. 177.1950 and 177.1980 (21 CFR 177.1950 
and 177.1980), respectively, intended for use in the manufacture of 
pipes and pipe fittings that will contact water in food processing 
plants. For these purposes, methyltin-2-mercaptoethyloleate sulfide is 
defined as one or more of the following:
    1. 9-Octadecenoic acid (Z)-, 2-mercaptoethyl ester, reaction 
products with dichlorodimethylstannane, sodium sulfide, and 
trichloromethylstannane (CAS Reg. No. 68442-12-6); or
    2. Fatty acids, tall oil, 2-mercaptoethyl esters, reaction products 
with dichlorodimethylstannane, 2-mercaptoethyl decanoate, 2-
mercaptoethyl octanoate, sodium sulfide, and trichloromethylstannane 
(CAS Reg. No. 151436-98-5); or
    3. Fatty acids, tall oil, 2-mercaptoethyl esters, reaction products 
with dichlorodimethylstannane, sodium sulfide, and 
trichloromethylstannane (CAS Reg. No. 201687-57-2).
    In addition, FDA announced in the September 7, 1999, notice that it 
was amending the filing notice of October 21, 1994, to indicate that 
the petitioner requested that the food additive regulations be amended 
to provide for the safe use of methyltin-2-mercaptoethyloleate sulfide 
as a heat stabilizer for use in rigid PVC and rigid vinyl chloride 
copolymers, complying with Secs. 177.1950 and 177.1980, respectively, 
intended for use in the manufacture of pipes and pipe fittings that 
will contact water in food processing plants, in combination with the 
following optional substances:
    1. 2-Mercaptoethyl oleate (CAS Reg. No. 59118-78-4), or 2-
mercaptoethyl tallate (CAS Reg. No. 68440-24-4), or 2-mercaptoethyl 
octanoate (CAS Reg. No. 57813-59-9), or 2-mercaptoethyl decanoate (CAS 
Reg. No. 68928-33-6), alone or in combination;
    2. 2-Mercaptoethanol (CAS Reg. No. 60-24-2);
    3. Mineral oil (CAS Reg. No. 8012-95-1); or
    4. Butylated hydroxytoluene (CAS Reg. No. 128-37-0).
    FDA has evaluated the data in the petition and other relevant 
material. Based on this information, the agency concludes that: (1) The 
proposed use of the additive is safe, (2) the additive will achieve its 
intended technical effect, and (3) the regulations in 21 CFR 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 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 rule as announced in the notice of filing for FAP 4B4430 (64 FR 
48655). 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 file with the Dockets Management Branch (address above) 
written objections by April 24, 2000. 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:

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

    2. Section 178.2010 is amended in the table in paragraph (b) by 
alphabetically adding an entry under the headings ``Substances'' and 
``Limitations'' to read as follows:


Sec. 178.2010  Antioxidants and/or stabilizers for polymers.

* * * * *
    (b) * * *

[[Page 15547]]



 
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             Substances                          Limitations
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  *                  *                  *                  *
                  *                  *                  *
Methyltin-2-mercaptoethyloleate      For use only in rigid poly(vinyl
 sulfide, which is defined as one     chloride) and rigid vinyl chloride
 or more of the following:            copolymers complying with Secs.
                                      177.1950 and 177.1980 of this
                                      chapter, respectively, used in the
                                      manufacture of pipes and pipe
                                      fittings intended for contact with
                                      water in food processing plants,
                                      at levels not to exceed:
                                     1. 1.0 percent by weight in pipes,
                                      and
                                     2. 2.0 percent by weight in pipe
                                      fittings.
        1. 9-Octadecenoic acid (Z)-
         , 2-mercaptoethyl ester,
         reaction products with
         dichlorodime thylstannane,
         sodium sulfide, and
         trichloromethylstannane
         (CAS Reg. No. 68442-12-6);
        2. Fatty acids, tall oil, 2-
         mercaptoethyl esters,
         reaction products with
         dichlorodimethylstannane,
         2-mercaptoethyl decanoate,
         2-mercaptoethyl octanoate,
         sodium sulfide, and
         trichloromethylstannane
         (CAS Reg. No. 151436-98-
         5); or
        3. Fatty acids, tall oil, 2-
         mercaptoethyl esters,
         reaction products with
         dichlorodimethylstannane,
         sodium sulfide, and
         trichloromethylstannane
         (CAS Reg. No. 201687-57-
         2);and which has the
         following specifications:
         Tin content (as Sn) 5 to
         21 percent by weight;
         mercaptosulfur content 5
         to 13 percent by weight;
         acid value no greater than
         4.
        Methyltin-2-
         Mercaptoethyloleate
         sulfide may also be used
         with one or more of the
         following optional
         substances:
        1.1a 2-Mercaptoethyl oleate
         (CAS Reg. No. 59118-78-4),
        1.1b 2-Mercaptoethyl
         tallate (CAS Reg. No.
         68440-24-4),
        1.1c 2-Mercaptoethyl
         octanoate (CAS Reg. No.
         57813-59-9),
        1.1d 2-Mercaptoethyl
         decanoate (CAS Reg. No.
         68928-33-6), alone or in
         combination; not to exceed
         40 percent by weight of
         the stabilizer
         formulation;
        2.1 2-Mercaptoethanol (CAS
         Reg. No. 60-24-2): Not to
         exceed 2 percent by weight
         of the stabilizer
         formulation.
        3.1 Mineral oil (CAS Reg.
         No. 8012-95-1): Not to
         exceed 40 percent by
         weight of the stabilizer
         formulation.
        4.1 Butylated
         hydroxytoluene (CAS Reg.
         No. 128-37-0): Not to
         exceed 5 percent by weight
         of the stabilizer
         formulation.
        The total of the optional
         substances (1.1a through
         4.1) shall not exceed 60
         percent by weight of the
         stabilizer formulation.
  *                  *                  *                  *
                  *                  *                  *
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    Dated: February 29, 2000.
L. Robert Lake,
Director, Office of Policy, Planning and Strategic Initiatives, Center 
for Food Safety and Applied Nutrition.
[FR Doc. 00-7011 Filed 3-22-00; 8:45 am]
BILLING CODE 4160-01-F