[Federal Register Volume 63, Number 138 (Monday, July 20, 1998)]
[Rules and Regulations]
[Pages 38747-38749]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-19174]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 178
[Docket No. 97F-0405]
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 aluminum borate as
an antistatic agent and/or antifogging agent for olefin polymers
intended for use as packaging materials in contact with food. This
action is in response to a petition filed by Shikoku Chemical Corp.
DATES: The regulation is effective July 20, 1998; written objections
and requests for a hearing by August 19, 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 September 25, 1997 (62 FR 50387), FDA announced that a food
additive petition (FAP 7B4559) had been filed by Shikoku Chemical
Corp., c/o SRS International Corp., suite 1000, 1625 K St. NW.,
Washington, DC 20006-1604. The petition proposed to amend the food
additive regulations in Sec. 178.3130 Antistatic and/or antifogging
agents in food-packaging materials (21 CFR 178.3130) to provide for the
safe use of aluminum borate as an antistatic and/or antifogging agent
for olefin polymers complying with 21 CFR 177.1520(c) as packaging
materials 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, that the additive will achieve its intended
technical effect, and therefore, that the regulations in Sec. 178.3130
should be amended as set forth below.
In accordance with Sec. 171.1(h) (21 CFR 171.1(h)), the petition
and the
[[Page 38748]]
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 7B4559 (62 FR
50387, September 25, 1997). 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 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 19, 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.
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 178.3130 is amended in the table in paragraph (b) by
alphabetically adding an entry under the headings ``List of
substances'' and ``Limitations'' to read as follows:
Sec. 178.3130 Antistatic and/or antifogging agents in food-packaging
materials.
* * * * *
(b) * * *
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List of substances Limitations
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* * * * * *
*
Aluminum Borate ((9Al2O3)2(B2O3), CAS Reg. No. For use only:
11121-16-7) produced by reaction between aluminum 1. At levels not to exceed 1 percent by weight of
oxide and/or aluminum hydroxide with boric acid and/or polypropylene films complying with Sec. 177.1520(c)
metaboric acid at temperatures in excess of 1000 C of this chapter, item 1.1, of polyethylene films
complying with Sec. 177.1520(c) of this chapter,
items 2.1 and 2.2 and having a density greater than
0.94 gram per cubic centimeter, and of polyolefin
copolymer films complying with Sec. 177.1520(c) of
this chapter, items 3.1(a), 3.1(b), 3.2(a), and
3.2(b). The finished polymers may be used in contact
with all food types identified in Table 1 of Sec.
176.170(c) of this chapter, under conditions of use A
through H as described in Table 2 of Sec. 176.170(c)
of this chapter. The thickness of the films shall not
exceed 0.005 inch.
2. At levels not to exceed 2 percent by weight of
polypropylene films complying with Sec. 177.1520(c)
of this chapter, item 1.1, of polyethylene films
complying with Sec. 177.1520(c) of this chapter,
items 2.1 and 2.2 and having a density greater than
0.94 gram per cubic centimeter, and of polyolefin
copolymer films complying with Sec. 177.1520(c) of
this chapter, items 3.1(a), 3.1(b), 3.2(a), and
3.2(b). The finished polymers may be used in contact
with all food types identified in Table 1 of Sec.
176.170(c) of this chapter under conditions of use B
through H as described in Table 2 of Sec. 176.170(c)
of this chapter. The thickness of the films shall not
exceed 0.005 inch.
* * * * * *
*
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[[Page 38749]]
Dated: June 24, 1998.
L. Robert Lake,
Director, Office of Policy, Planning and Strategic Initiatives, Center
for Food Safety and Applied Nutrition.
[FR Doc. 98-19174 Filed 7-17-98; 8:45 am]
BILLING CODE 4160-01-F
