[Federal Register Volume 64, Number 171 (Friday, September 3, 1999)]
[Rules and Regulations]
[Pages 48290-48291]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-22996]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 175
[Docket No. 99F-1420]
Indirect Food Additives: Adhesives and Components of Coatings
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 butylated reaction
product of p-cresol and dicyclopentadiene as an antioxidant in
pressure-sensitive adhesives intended for use in contact with food.
This action responds to a petition filed by Goodyear Tire and Rubber
Co.
DATES: This regulation is effective September 3, 1999. Submit written
objections and requests for a hearing by October 4, 1999.
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 May 26, 1999 (64 FR 28500), FDA announced that a food additive
petition (FAP 9B4663) had been filed by Goodyear Tire and Rubber Co.,
c/o Keller and Heckman LLP, 1001 G St. NW., suite 500 West, Washington,
DC 20001. The petition proposed to amend the food additive regulations
in Sec. 175.125 Pressure-sensitive adhesives (21 CFR 175.125) to
provide for the safe use of butylated reaction product of p-cresol and
dicyclopentadiene as an antioxidant in pressure-sensitive adhesives
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: (1) The proposed
use of the additive is safe, (2) the additive will achieve its intended
technical effect, and therefore, (3) the regulations in Sec. 175.125
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 final rule as announced in the Notice of Filing for FAP 9B4663 (64
FR 28500). 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 October 4, 1999, 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
[[Page 48291]]
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 175
Adhesives, 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 175 is amended as follows:
PART 175--INDIRECT FOOD ADDITIVES: ADHESIVES AND COMPONENTS OF
COATINGS
1. The authority citation for 21 CFR part 175 continues to read as
follows:
Authority: 21 U.S.C. 321, 342, 348, 379e.
2. Section 175.125 is amended in paragraph (b)(2) by alphabetically
adding an entry to read as follows:
Sec. 175.125 Pressure-sensitive adhesives.
* * * * *
(b) * * *
(2) * * *
Butylated reaction product of p-cresol and dicyclopentadiene
produced by reacting p-cresol and dicyclopentadiene in an
approximate mole ratio of 1.5 to 1.0, respectively, followed by
alkylation with isobutylene so that the butyl content of the final
product is not less than 18 percent, for use at levels not to exceed
1.0 percent by weight of the adhesive formulation.
* * * * *
Dated: August 26, 1999.
L. Robert Lake,
Director, Office of Policy, Planning and Strategic Initiatives, Center
for Food Safety and Applied Nutrition.
[FR Doc. 99-22996 Filed 9-2-99; 8:45 am]
BILLING CODE 4160-01-F