[Federal Register Volume 63, Number 202 (Tuesday, October 20, 1998)]
[Rules and Regulations]
[Pages 55942-55944]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-27993]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 177
[Docket No. 96F-0107]
Indirect Food Additives: Polymers
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 a polyester-
polyurethane resin-acid dianhydride adhesive in retortable pouches
intended for use in contact with food.
DATES: The regulation is effective October 20, 1998. Submit written
objections and requests for a hearing by November 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.
[[Page 55943]]
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 April 23, 1996 (61 FR 17901), FDA announced that a food
additive petition (FAP 6B4496) had been filed by Dainippon Ink and
Chemicals, Inc., c/o Center for Regulatory Services, 2347 Paddock Lane,
Reston, VA 22091. The petition proposed to amend the food additive
regulations in Sec. 177.1390 Laminate structures for use at
temperatures of 250 deg.F and above (21 CFR 177.1390) to permit the
safe use of aliphatic polyester-polyurethane resin-acid dianhydride
adhesive in retortable pouches intended for use in contact with food.
When the petition was filed, it contained an environmental
assessment (EA). In the notice of filing (61 FR 17901), the agency
announced that it was placing the EA on display at the Dockets
Management Branch (address above) for public review and comment. No
comments were received. In the Federal Register of July 29, 1997 (62 FR
40570), FDA published a document that revised regulations under part 25
(21 CFR part 25), which became effective on August 28, 1997. On March
24, 1998, the petitioner made a claim of categorical exclusion under
the new paragraph in Sec. 25.32(i), in accordance with the procedures
in Sec. 25.15(a) and (d). Because the agency had not completed its
review of the earlier submitted EA, the agency reviewed the claim of
categorical exclusion under Sec. 25.32(i) for this final rule.
The additive was identified in the filing notice as an aliphatic
polyester-polyurethane resin-acid dianhydride adhesive. It is unclear
to which structural unit the term aliphatic applies, and moreover, such
distinction is not necessary to adequately identify the chemical
composition of the additive. Therefore, the additive will be listed as
a polyester-polyurethane resin-acid dianhydride adhesive in this final
rule.
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. 177.1390
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 determined under Sec. 25.32(i) that this action is
of a type that does not individually or cumulatively have a significant
effect on the human environment. Therefore, neither an EA nor an
environmental impact statement is required.
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.
Any person who will be adversely affected by this regulation may at
any time on or before November 19, 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 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 objection 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 177
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 177 is amended as follows:
PART 177--INDIRECT FOOD ADDITIVES: POLYMERS
1. The authority citation for 21 CFR part 177 continues to read as
follows:
Authority: 21 U.S.C. 321, 342, 348, 379e.
2. Section 177.1390 is amended by adding paragraph (c)(2)(vii) and
by revising paragraph (c)(3)(i)(a)(1) to read as follows:
Sec. 177.1390 Laminate structures for use at temperatures of 250
deg.F and above.
* * * * *
(c) * * *
(2) * * *
(vii) Polyester-polyurethane resin-acid dianhydride adhesives for
use at temperatures not to exceed 121 deg.C (250 deg.F), in contact
only with food Types I, II, VIA, VIB, VIIB, and VIII as described in
Table I of Sec. 176.170 of this chapter, and formulated from the
following mixture:
(a)(1) Polyesterpolyurethanediol resins prepared by the reaction of
a mixture of polybasic acids and polyhydric alcohols listed in
Sec. 175.300(b)(3)(vii) of this chapter and 3-isocyanatomethyl-3,5,5-
trimethylcyclohexyl isocyanate (CAS Reg. No. 4098-71-9). Additionally,
dimethylol propionic acid and 1,6-hexanediol may be used alone or in
combination as reactants in lieu of a polybasic acid and a polyhydric
alcohol.
(2) Acid dianhydride formulated from 3a,4,5,7a-tetrahydro-7-methyl-
5-(tetrahydro-2,5-dioxo-3-furanyl)-1,3-isobenzofurandione (CAS Reg. No.
73003-90-4), comprising not more than one percent of the cured
adhesive.
(b) Urethane cross-linking agent, comprising not more than twelve
percent by weight of the cured adhesive, and formulated from
trimethylol propane (CAS Reg. No. 77-99-6) adducts of 3-
isocyanatomethyl-3,5,5-trimethylcyclohexyl isocyanate (CAS Reg. No.
4098-71-9) and/or 1,3-bis(isocyanatomethyl)benzene (CAS Reg. No. 363-
48-31).
(3) * * *
(i) * * *
(a) * * *
(1) The chloroform-soluble fraction of the total nonvolatile
extractives for containers using adhesives listed in paragraphs
(c)(2)(i), (c)(2)(ii), (c)(2)(iii), (c)(2)(iv), and (c)(2)(vii) of this
section shall not exceed 0.0016 milligram per square centimeter (0.01
milligram per square inch) as determined by a method entitled
``Determination of Non-Volatile Chloroform Soluble Residues in Retort
Pouch Water Extracts,'' which is incorporated by reference. Copies are
available from the Center for Food Safety and Applied Nutrition (HFS-
[[Page 55944]]
200), Food and Drug Administration, 200 C St. SW., Washington, DC
20204, and may be examined at the Center for Food Safety and Applied
Nutrition's Library, 200 C St. SW., rm. 3321, Washington, DC, or at the
Office of the Federal Register, 800 North Capitol St. NW., suite 700,
Washington, DC 20408.
* * * * *
Dated: October 1, 1998.
L. Robert Lake,
Director, Office of Policy, Planning and Strategic Initiatives, Center
for Food Safety and Applied Nutrition.
[FR Doc. 98-27993 Filed 10-19-98; 8:45 am]
BILLING CODE 4160-01-F