[Federal Register Volume 63, Number 166 (Thursday, August 27, 1998)]
[Rules and Regulations]
[Pages 45715-45716]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-23029]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 178
[Docket No. 98F-0057]
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 calcium
bis[monoethyl(3,5-di-tert-butyl-4-hydroxybenzyl)phosphonate] as a
stabilizer for polyethylene phthalate polymers intended for use in
contact with food. This action is in response to a petition filed by
Ciba Specialty Chemicals Corp.
DATES: The regulation is effective August 27, 1998; written objections
and requests for a hearing by September 28, 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 February 6, 1998 (63 FR 6193), FDA announced that a food
additive petition (FAP 8B4578) had been filed by Ciba Specialty
Chemicals Corp., 540 White Plains Rd., Tarrytown, NY 10591-9005. 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 calcium bis[monoethyl(3,5-di-
tert-butyl-4-hydroxybenzyl)phosphonate] as a stabilizer for
polyethylene phthalate polymers complying with 21 CFR 177.1630,
intended for use in contact with food.
FDA has evaluated data in the petition and other relevant material.
[[Page 45716]]
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 therefore, that 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 8B4578 (63 FR
6193). 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 on or before September 28, 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 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) for
the entry ``calcium bis[monoethyl(3,5-di-tert-butyl-4-
hydroxybenzyl)phosphonate]'' by adding entry ``15'' 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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* * *
Calcium bis[monoethyl(3,5-di-tert- For use only:
butyl-4-hydroxybenzyl)phosphonate] * * *
(CAS Reg. No. 65140-91-2). 15. At levels not to exceed 0.3
percent by weight of polyethylene
phthalate polymers, complying with
Sec. 177.1630 of this chapter.
Provided, that the finished
polymers contact food only under
conditions of use B through H
described in Table 2 of Sec.
176.170(c) of this chapter.
* * * *
* * *
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Dated: August 17, 1998.
L. Robert Lake,
Director, Office of Policy, Planning and Strategic Initiatives, Center
for Food Safety and Applied Nutrition.
[FR Doc. 98-23029 Filed 8-26-98; 8:45 am]
BILLING CODE 4160-01-F