[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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