[Federal Register Volume 64, Number 172 (Tuesday, September 7, 1999)]
[Notices]
[Page 48655]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-23127]



[[Page 48655]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 94F-0334]


Morton International, Inc.; Filing of Food Additive Petition; 
Amendment

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is amending the filing 
notice for a food additive petition filed by Morton International, 
Inc., to indicate that the petitioner has proposed that the food 
additive regulations be amended to provide for the safe use of 
methyltin-2-mercaptoethyloleate sulfide used alone or in combination 
with several other optional substances as a heat stabilizer for use in 
rigid poly(vinyl chloride) and rigid vinyl chloride copolymers intended 
for use in the manufacture of pipes and pipe fittings that will contact 
water in food processing plants.

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.

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 that 
the food additive regulations in Sec. 178.2010 Antioxidants and/or 
stabilizers for polymers (21 CFR 178.2010) be amended to provide for 
the safe use of methyltin-2-mercaptoethyloleate sulfide mixtures as 
heat stabilizers for use in polyvinyl chloride pipes intended for 
transporting water for food contact.
    Subsequent to the publication of the filing notice, FDA has 
determined that methyltin-2-mercaptoethyloleate sulfide is a complex 
mixture of 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 has determined that the petition also proposes 
that the methyltin-2-mercaptoethyloleate sulfide may be used 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).
    Finally, FDA has determined that the petition requests the use of 
methyltin-2-mercaptoethyloleate sulfide and the above optional 
substances as a heat stabilizer in rigid poly(vinyl chloride) and rigid 
vinyl chloride copolymers, complying with Secs. 177.1950 and 177.1980, 
respectively. The rigid poly(vinyl chloride) and rigid vinyl chloride 
copolymers are intended for use in the manufacture of pipes and pipe 
fittings that will contact water in food processing plants.
    Therefore, FDA is 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 that 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); as a heat 
stabilizer for use in rigid poly(vinyl chloride) 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 addition, FDA is 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 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); as a heat 
stabilizer for use in rigid poly(vinyl chloride) 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.
    When the petition was first filed on October 21, 1994, it contained 
an environmental assessment (EA). In that notice of filing, the agency 
announced that it was placing the EA on display at the Dockets 
Management Branch for public review and comment. No comments were 
received. In the Federal Register of July 29, 1997 (62 FR 40570), FDA 
published revised regulations under part 25 (21 CFR part 25), which 
became effective on August 28, 1997. On June 4, 1999, the petitioner 
submitted a claim of categorical exclusion under the new Sec. 25.32(j), 
in accordance with the procedures in Sec. 25.15(a) and (d). The agency 
has reviewed the claim of categorical exclusion under Sec. 25.32(j).
    The agency has determined under Sec. 25.32(j) that this action is 
of a type that does not individually or cumulatively have a significant 
effect on the human environment. Therefore, neither an environmental 
assessment nor an environmental impact statement is required.

    Dated: August 18, 1999.
Alan M. Rulis,
Director, Office of Premarket Approval, Center for Food Safety and 
Applied Nutrition.
[FR Doc. 99-23127 Filed 9-3-99; 8:45 am]
BILLING CODE 4160-01-F