[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