[Federal Register Volume 63, Number 127 (Thursday, July 2, 1998)]
[Rules and Regulations]
[Pages 36177-36178]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-17544]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 178
[Docket No. 97F-0469]
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 expanded safe use of
phosphorous acid, cyclic butylethyl propanediol, 2,4,6-tri-tert-
butylphenyl ester, which may contain up to 1 percent by weight of
triisopropanolamine, as an antioxidant and/or stabilizer in high-
density polyethylene and high-density olefin copolymers intended for
use in contact with food. This action is in response to a petition
filed by General Electric Co.
DATES: This regulation is effective July 2, 1998. Written objections
and requests for a hearing by August 3, 1998.
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: Vir D. Anand, Center for Food Safety
and Applied Nutrition (HFS-215), Food and Drug Administration, 200 C
St. SW., Washington, DC 20204, 202-418-3081.
SUPPLEMENTARY INFORMATION: In a notice published in the Federal
Register of November 20, 1997 (62 FR 62062), FDA announced that a food
additive petition (FAP 8B4567) had been filed by General Electric Co.,
One Lexan Lane, Mt. Vernon, IN 47620-9364. 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
expanded safe use of phosphorous acid, cyclic butylethyl propanediol,
2,4,6-tri-tert-butylphenyl ester, which may contain up to 1 percent by
weight of triisopropanolamine, as an antioxidant and/or stabilizer in
high-density polyethylene and high-density olefin copolymers (more
appropriately identified as high-density polyethylene homopolymers and
copolymers) intended for use in contact with food.
FDA has evaluated data in the petition and other relevant material.
Based on this information, the agency concludes that the proposed use
of the additive is safe and that the additive will achieve its intended
technical effect. Therefore, the regulations in 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 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 8B4567 (62 FR
62062). FDA has concluded that the action is of the type that does not
individually or cumulatively have a significant effect on the human
environment, and that therefore, neither an environmental assessment
nor an environmental impact statement is required.
Any person who will be adversely affected by this regulation may at
any time on or before August 3, 1998, 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 objection received in
response to the regulation may be seen in the Dockets Management Branch
[[Page 36178]]
between 9 a.m. and 4 p.m., Monday through Friday.
This final rule contains no collections of information. Therefore,
clearance by the Office of Management and Budget under the Paperwork
Reduction Act of 1995 is not required.
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
revising the entry for ``Phosphorous acid, cyclic butylethyl
propanediol, 2,4,6-tri-tert-butylphenyl ester'' by adding item ``4.''
under the heading ``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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* * * *
* * *
Phosphorous acid, cyclic butylethyl For use only:
propanediol, 2,4,6-tri-tert- * * *
butylphenyl ester (CAS Reg. No. 4. At levels not to exceed 0.1
161717-32-4), which may contain percent by weight of olefin
not more than 1 percent by weight polymers complying with Sec.
of triisopropanolamine (CAS Reg. 177.1520(c) of this chapter, items
No. 122-20-3). 2.1, 2.2, 2.3, 3.1(a), 3.1(b),
3.1(c), 3.2 (a), or 3.2(b), having
a density not less than 0.94 grams
per cubic centimeter, in contact
with foods only of types III, IV,
V, VI-A, VI-C, VII, VIII, and IX
identified in Table 1 of Sec.
176.170(c) of this chapter, and
under conditions of use B through
H as described in Table 2 of Sec.
176.170(c) of this chapter;
provided that the food-contact
surface does not exceed 0.003 inch
(0.076 mm) in thickness.
* * * *
* * *
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Dated: June 23, 1998.
L. Robert Lake,
Director, Office of Policy, Planning and Strategic Initiatives, Center
for Food Safety and Applied Nutrition.
[FR Doc. 98-17544 Filed 7-1-98; 8:45 am]
BILLING CODE 4160-01-F
