[Federal Register Volume 61, Number 159 (Thursday, August 15, 1996)]
[Rules and Regulations]
[Pages 42378-42379]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-20858]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 175
[Docket No. 96F-0053]
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 1,4-
cyclohexanedicarboxylate as a monomer in polyester resins employed in
adhesives as components of articles intended for use in contact with
food. This action is in response to a petition filed by Eastman
Chemical Co.
DATES: Effective August 15, 1996; written objections and requests for a
hearing by September 16, 1996.
ADDRESSES: Submit written objections to the Dockets Management Branch
(HFA-305), Food and Drug Administration, 12420 Parklawn Dr., rm. 1-23,
Rockville, MD 20857.
FOR FURTHER INFORMATION CONTACT: Vir D. Anand, Center for Food Safety
and Applied Nutrition (HFS-216), 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 26, 1996 (61 FR 7111), FDA announced that a food
additive petition (FAP 5B4481) had been filed by Eastman Chemical Co.,
P.O. Box 1994, Kingsport, TN 37662. The petition proposed to amend the
food additive regulations in Sec. 175.105 Adhesives (21 CFR 175.105) to
provide for the safe use of dimethyl 1,4-cyclohexanedicarboxylate as a
monomer in polyester resins employed in adhesives as components of
articles intended for use in contact with food.
-FDA has evaluated the data in the petition and other relevant
material. The agency concludes that: (1) The proposed use of the food
additive is safe, (2) the food additive will have the intended
technical effect, and (3) the regulations in Sec. 175.105 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 action. FDA has concluded that the action will not have
a significant impact on the human environment, and that an
environmental impact statement is not required. The agency's finding of
no significant impact and the evidence supporting that finding,
contained in an environmental assessment, may be seen in the Dockets
Management Branch (address above) between 9 a.m. and 4 p.m., Monday
through Friday.
Any person who will be adversely affected by this regulation may at
any time on or before September 16, 1996, 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 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:
[[Page 42379]]
-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: Secs. 201, 402, 409, 721 of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 321, 342, 348, 379e).
2. Section 175.105 is amended in the table in paragraph (c)(5) by
alphabetically adding a new entry under the heading ``Substances'' and
the subheading ``Acids'' appearing after the entry for ``Polyester
resins * * *'' to read as follows (for the convenience of the reader,
the introductory text for ``Polyester resins'' is republished):
Sec. 175.105 Adhesives.
* * * * *
(c) * * *
(5) * * *
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Substances Limitations
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* * * * * *
*
Polyester resins (including alkyd type), as the basic
polymer, formed as esters when one or more of the
following acids are made to react with one or more of
the following alcohols:
Acids:
* * * * * *
*
Dimethyl 1,4-cyclohexanedicarboxylate
(CAS Reg. No. 94-60-0).
* * * * * *
*
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Dated: July 29, 1996.
Fred R. Shank,
Director, Center for Food Safety and Applied Nutrition.
[FR Doc. 96-20858 Filed 8-14-96; 8:45 am]
BILLING CODE 4160-01-F