[Federal Register Volume 63, Number 127 (Thursday, July 2, 1998)]
[Rules and Regulations]
[Pages 36176-36177]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-17545]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 178
[Docket No. 97F-0468]
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 tris(2,4-di-tert-
butylphenyl)phosphite by removing the restrictions on the temperature
of use in low-density polyethylene films of thickness greater than
0.051 millimeter (mm) (0.002 inch (in)), provided that the film does
not contain a total of tris(2,4-di-tert-butylphenyl)phosphite in excess
of 0.062 milligram (mg) per square inch (in2) of the food-
contact surface. This action is in response to a petition filed by Ciba
Specialty Chemicals Corp.
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 28, 1997 (62 FR 63350), FDA announced that a food
additive petition (FAP 8B4563) had been filed by Ciba Specialty
Chemicals Corp., c/o Keller and Heckman, 1001 G St. NW., suite 500
West, Washington, DC 20001. 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 tris(2,4-
di-tert-butylphenyl)phosphite by removing the restriction on the
temperature of use in low-density polyethylene films of thickness
greater than 0.051 mm (0.002 in), provided that the film does not
contain a total of tris(2,4-di-tert-butylphenyl)phosphite in excess of
0.062 mg per in2 of the food contact-surface.
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, that the additive will achieve its intended
technical effect, and that 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 8B4563 (62 FR
63350). FDA has concluded that the action is of a 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
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 ``tris(2,4-di-tert-butylphenyl)phosphite'' in
item ``6.'' under the heading ``Limitations'' to read as follows:
Sec. 178.2010 Antioxidants and/or stabilizers for polymers.
* * * * *
(b) * * *
[[Page 36177]]
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Substances Limitations
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* * * * * *
*
Tris(2,4-di-tert-butylphenyl)phosphite. (CAS Reg. No. For use only:
31570-04-4). * * *
6. At levels not to exceed 0.2 percent by weight of
olefin polymers complying with Sec. 177.1520(c) of
this chapter, items 2.1, 2.2, 2.3, 3.1(a), 3.1(b),
3.1(c), 3.2(a), or 3.2(b). The finished polymers
complying with items 2.1, 2.2, or 2.3 having a density
less than 0.94 gram per cubic centimeter and a
thickness greater than 0.051 millimeter (0.002 inch),
either shall have a level of tris(2,4-di-tert-
butylphenyl)phosphite that shall not exceed 0.062
milligram per square inch of food-contact surface or
shall contact all food types identified in Table 1 of
Sec. 176.170(c) of this chapter only under conditions
of use E, F, and G described in Table 2 of Sec.
176.170(c) of this chapter.
* * * * * *
*
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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. 98-17545 Filed 7-1-98; 8:45 am]
BILLING CODE 4160-01-F
