[Federal Register Volume 65, Number 127 (Friday, June 30, 2000)]
[Rules and Regulations]
[Pages 40496-40498]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-16527]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 176

[Docket Nos. 94F-0185 and 95F-0111]


Indirect Food Additives: Paper and Paperboard Components

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 1,3-dihalo-5,5-
dimethylhydantoin (where the dihalo (halogen) may be bromine and/or 
chlorine) that may contain no more than 20 weight percent 1,3-dihalo-5-
ethyl-5-methylhydantoin (where the dihalo (halogen) may be bromine and/
or chlorine), as a slimicide in the manufacture of paper and paperboard 
intended to contact food. This action is in response to petitions filed 
by Great Lakes Chemical Corp. and Lonza, Inc.

DATES: This rule is is effective June 30, 2000. Submit written 
objections and requests for a hearing by July 31, 2000.

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: Vivian M. Gilliam, Center for Food 
Safety and Applied Nutrition (HFS-215), Food and Drug Administration, 
200 C St. SW., Washington, DC 20204, 202-418-3094.

SUPPLEMENTARY INFORMATION: In a notice published in the Federal 
Register of June 14, 1994 (59 FR 30595), FDA announced that a food 
additive petition (FAP 4B4418) had been filed by Great Lakes Chemical 
Corp., P.O. Box 2200, West Lafayette, IN 47906-0200. The company is 
currently represented by Keller and Heckman, 1001 G St. NW., suite 500 
West, Washington, DC 20001. The Great Lakes petition proposed to amend 
the food additive regulations in Sec. 176.300 Slimicides (21 CFR 
176.300) to provide for the safe use of 1-bromo-3-chloro-5,5-
dimethylhydantoin (CAS Reg. No. 16079-88-2) as a slimicide in the 
manufacture of paper and paperboard intended to contact food.
    Thereafter, in a notice published in the Federal Register of June 
14, 1995 (60 FR 31319), FDA announced that a food additive petition 
(FAP 3B4382) had been filed by Lonza, Inc., c/o Delta Analytical Corp., 
7910 Woodmont Ave., Bethesda, MD 20814. Lonza, Inc., is currently 
represented by Lewis and Harrison, 122 C St. NW., suite 740, 
Washington, DC 20001. The Lonza petition proposed to amend the food 
additive regulations in Sec. 176.300 to provide for the safe use of a 
mixture of 1-bromo-3-chloro-5,5-dimethylhydantoin, 1,3-dichloro-5,5-
dimethylhydantoin, and 1,3-dichloro-5-ethyl-5-methylhydantoin as a 
slimicide in the manufacture of paper and paperboard intended to 
contact food.
    In the filing notice for FAP 4B4418, the additive was identified as 
1-bromo-3-chloro-5,5-dimethylhydantoin (CAS Reg. No. 16079-88-2). This 
nomenclature and this CAS Reg. No. apply to a single discrete 
substance; however, the additive is actually an equilibrium isomeric 
mixture of halogenated 5,5-dimethylhydantoin species. Subsequent to the 
filing of the petition, Great Lakes Chemical Corp. and FDA agreed that 
the additive is more appropriately identified as 1,3-dihalo-5,5-
dimethylhydantoin (where the dihalo (halogen) may be bromine and/or 
chlorine).
    In the filing notice for FAP 3B4382, the additive was identified as 
a mixture of 1-bromo-3-chloro-5,5-dimethylhydantoin and 1,3-dichloro-
5,5-dimethylhydantoin and 1,3-dichloro-5-ethyl-5-methylhydantoin. 
However, the additive is actually an equilibrium isomeric mixture of 
halogenated 5,5-dimethylhydantoin and 5-ethyl-5-methyl hydantoin 
species. Lonza, Inc., and FDA agreed that the additive is more 
appropriately identified as 1,3-dihalo-5,5-dimethylhydantoin (where the 
dihalo (halogen) may be bromine and/or chlorine) that may contain no 
more than 20 weight percent 1,3-dihalo-5-ethyl-5-methylhydantoin (where 
the dihalo (dihalo (halogen) may be bromine and/or chlorine). This 
description includes the use proposed by both Great Lakes Chemical 
Corp. and Lonza, Inc. Therefore, this final rule responds to both 
petitions.
    FDA has evaluated data in the petitions and other relevant 
material. Based on this information, the agency concludes that: (1) The 
proposed use of the additive, 1,3-dihalo-5,5-dimethylhydantoin (where 
the dihalo (halogen) may be bromine and/or chlorine) that may contain 
no more than 20 weight percent 1,3-dihalo-5-ethyl-5-methylhydantoin 
(where the dihalo (halogen) may be bromine and/or chlorine), as a 
slimicide in the manufacture of paper and paperboard intended to 
contact food is safe; (2) the additive will achieve its intended 
technical effect; and therefore, (3) the regulations in Sec. 176.300 
should be amended as set forth below.
    The additive, 1,3-dihalo-5,5-dimethylhydantoin (where the dihalo 
(halogen) may be bromine and/or chlorine) that may contain no more than 
20 weight percent 1,3-dihalo-5-ethyl-5-methylhydantoin (where the 
dihalo (halogen) may be bromine and/or chlorine) intended for use as a 
slimicide in the manufacture of paper and paperboard intended to 
contact food is regulated under section 409 of the Federal Food, Drug, 
and Cosmetic Act (the act) (21 U.S.C. 348) as a food additive and not 
as a pesticide chemical under section 408 of the act (21 U.S.C. 346a). 
However, this intended use of 1,3-dihalo-5,5-dimethylhydantoin (where 
the dihalo (halogen) may be

[[Page 40497]]

bromine and/or chlorine) that may contain no more than 20 weight 
percent 1,3-dihalo-5-ethyl-5-methylhydantoin (where the dihalo 
(halogen) may be bromine and/or chlorine) may, nevertheless, be subject 
to regulation as a pesticide under the Federal Insecticide, Fungicide, 
and Rodenticide Act (FIFRA). Therefore, manufacturers intending to use 
food-contact articles containing 1,3-dihalo-5,5-dimethylhydantoin 
(where the dihalo (halogen) may be bromine and/or chlorine) that may 
contain no more than 20 weight percent 1,3-dihalo-5-ethyl-5-
methylhydantoin (where the dihalo (halogen) may be bromine and/or 
chlorine) as a slimicide in the manufacture of paper and paperboard 
intended to contact food should contact the Environmental Protection 
Agency to determine whether this use requires a pesticide registration 
under FIFRA.
    In accordance with Sec. 171.1(h) (21 CFR 171.1(h)), the petitions 
and the documents that FDA considered and relied upon in reaching its 
decision to approve the petitions 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.
    When both petitions were filed, they each contained an 
environmental assessment (EA). In the respective notices of filing, the 
agency announced that it was placing the EA's on display at the Dockets 
Management Branch for public review and comment. No comments were 
received on either EA. In addition, prior to completing our review of 
the EA submitted in FAP 3B4382, Lonza, Inc., submitted a claim of 
categorical exclusion under 21 CFR 25.32(q).
    The agency has carefully considered the potential environmental 
effects of this action. FDA has concluded that this 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.
    This final rule contains no collection 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 file with the Dockets Management Branch (address above) 
written objections by July 31, 2000. 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 are to be submitted and are to 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 176

    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 176 is amended as follows:

PART 176--INDIRECT FOOD ADDITIVES: PAPER AND PAPERBOARD COMPONENTS

    1. The authority citation for 21 CFR part 176 continues to read as 
follows:

    Authority: 21 U.S.C. 321, 342, 346, 348, 379e.
    2. Section 176.300 is amended in the table in paragraph (c) by 
alphabetically adding an entry under the headings ``List of 
substances'' and ``Limitations'' to read as follows:


Sec. 176.300  Slimicides.

* * * * *
    (c) * * *

 
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                                       List of substances                                                                                  Limitations
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1,3-Dihalo-5,5-dimethylhydantoin (where the dihalo (halogen) may be bromine and/or chlorine)     At a maximum level of 1.0 kilogram (kg) per 1,000 kg of dry weight fiber.
 that may contain no more than 20 weight percent 1,3-dihalo-5-ethyl-5-methylhydantoin (where
 the dihalo (halogen) may be bromine and/or chlorine).
                                *                    *                    *                    *                    *                    *                    *
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[[Page 40498]]

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    Dated: June 15, 2000.
L. Robert Lake,
Director of Regulations and Policy, Center for Food Safety and Applied 
Nutrition.
[FR Doc. 00-16527 Filed 6-29-00; 8:45 am]
BILLING CODE 4160-01-F