[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