[Federal Register Volume 63, Number 214 (Thursday, November 5, 1998)]
[Rules and Regulations]
[Pages 59706-59707]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-29615]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 175
[Docket No. 97F-0428]
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 dimethyl-2,6-
naphthalenedicarboxylate and 2,6-naphthalenedicarboxylic acid as
polybasic acids intended for use as components of resinous and
polymeric coatings that contact food. This action is in response to a
petition filed by Amoco Corp.
DATES: The regulation is effective November 5, 1998; written objections
and requests for a hearing by December 7, 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: Mark A. Hepp, Center for Food Safety
and Applied Nutrition (HFS-215), Food and Drug Administration, 200 C
St. SW., Washington, DC 20204, 202-418-3098.
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 7B4555) had been filed by Amoco Corp., One
Prudential Plaza, 130 East Randolph St., Chicago, IL 60601-6207. The
petition proposed to amend the food additive regulations in
Sec. 175.300 Resinous and polymeric coatings (21 CFR 175.300) to
include dimethyl-2,6-naphthalenedicarboxylate and 2,6-
naphthalenedicarboxylic acid as polybasic acids intended for use as
components of resinous and polymeric coatings that contact food.
FDA has evaluated data in the petition and other relevant
material. The agency concludes that the proposed use of the additives
as components of resinous and polymeric coatings that contact food is
safe, that the additives will have their intended technical effect, and
therefore, that the regulation in Sec. 175.300 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 carefully considered the potential environmental
effects of this rule as announced in the notice of filing for FAP
7B4555 (62 FR 62062, November 20, 1997). 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 collections of information. Therefore,
clearance by the Office of Management and Budget
[[Page 59707]]
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 December 7, 1998, file with the Dockets
Management Branch (address above) written objection 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 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 175.300 is amended in paragraph (b)(3)(vii)(a) by
alphabetically adding two entries to read as follows:
Sec. 175.300 Resinous and polymeric coatings.
* * * * *
(b) * * *
(3) * * *
(vii) * * *
(a) * * *
* * * * *
2,6-Naphthalenedicarboxylic.
2,6-Naphthalenedicarboxylic, dimethyl ester.
* * * * *
Dated: October 16, 1998.
L. Robert Lake,
Director, Office of Policy, Planning and Strategic Initiatives.
[FR Doc. 98-29615 Filed 11-4-98; 8:45 am]
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