[Federal Register Volume 65, Number 61 (Wednesday, March 29, 2000)]
[Rules and Regulations]
[Pages 16518-16520]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-7655]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 176

[Docket No. 93F-0132]


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 a mixture of 
hydroxymethyl-5,5-dimethylhydantoin and 1,3-bis(hydroxymethyl)-5,5-
dimethylhydantoin as a preservative in clay-type fillers for paper and 
paperboard intended for use in contact with aqueous and fatty food. 
This action is in response to a petition filed by Lonza, Inc.

DATES: This rule is effective March 29, 2000. Submit written objections 
and requests for a hearing by April 28, 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:

I. Background

    In a notice published in the Federal Register May 17, 1993 (58 FR 
28882), FDA announced that a food additive petition (FAP 3B4367) had 
been filed by Lonza, Inc., c/o Delta Analytical Corp., 1414 Fenwick 
Lane, Silver Spring, MD 20910. The petition proposed to amend the food 
additive regulations in Sec. 175.105 Adhesives (21 CFR 175.105), 
Sec. 175.300 Resinous and polymeric coatings (21 CFR 175.300), and 
Sec. 176.170 Components of paper and paperboard in contact with aqueous 
and fatty foods (21 CFR 176.170) to provide for the safe use of a 
mixture of hydroxymethyl-5,5-dimethylhydantoin and 1,3-
bis(hydroxymethyl)-5,5-dimethylhydantoin as a preservative in 
adhesives, resinous and polymeric coatings and clay-type fillers for 
paper and paperboard in food-contact articles. Lonza, Inc., is 
currently represented by Lewis and Harrison, 122 C St. NW., suite 740, 
Washington, DC 20001. (Formerly represented by Delta Analytical Corp. 
whose current address is 7910 Woodmont Ave., Bethesda, MD 20814).
    When the petition was filed on May 17, 1993, the petitioner 
proposed to amend the food additive regulations in Secs. 175.105, 
175.300, and 176.170. Subsequent to the filing of the petition, the 
petitioner amended the petition to limit the use of the additive to the 
manufacture of paper and paperboard under Sec. 176.170.
    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, a mixture of

[[Page 16519]]

hydroxymethyl-5,5-dimethylhydantoin and 1,3-bis(hydroxymethyl)-5,5-
dimethylhydantoin as a preservative in clay-type fillers for paper and 
paperboard intended to contact aqueous and fatty food is safe; (2) the 
additive will achieve its intended technical effect; and therefore, (3) 
the regulation in Sec. 176.170(a)(5) should be amended as set forth 
below.
    FDA's review of the petition indicates that the additive may 
contain trace amounts of formaldehyde as an impurity. The potential 
carcinogenicity of formaldehyde was reviewed by the Cancer Assessment 
Committee (the Committee) of FDA's Center for Food Safety and Applied 
Nutrition. The Committee noted that for many years, formaldehyde has 
been known to be a carcinogen by the inhalation route, but the 
Committee concluded that these inhalation studies are not appropriate 
for assessing the potential carcinogenicity of formaldehyde in food. 
The Committee's conclusion was based on the fact that the route of 
administration (inhalation) is not relevant to the safety of 
formaldehyde residues in food and the fact that tumors were observed 
only locally at the portal of entry (nasal turbinates). In addition, 
the agency has received literature reports of two-year drinking-water 
studies on formaldehyde: (1) A preliminary report of a carcinogenicity 
study purported to be positive by Soffritti et al. (1989), conducted in 
Bologna, Italy (Ref. 1); and (2) a negative study by Til et al. (1989), 
conducted in The Netherlands (Ref. 2). The Committee reviewed both 
studies and concluded, concerning the Soffritti study, ``* * * that 
data reported were unreliable and could not be used in the assessment 
of the oral carcinogenicity of formaldehyde'' (Ref. 3). This conclusion 
is based on a lack of critical detail in the study, questionable 
histopathological conclusions, and the use of unusual nomenclature to 
describe the tumors. Based on the Committee's evaluation, the agency 
has determined that there is no basis to conclude that formaldehyde is 
a carcinogen when ingested.
    A mixture of hydroxymethyl-5,5-dimethylhydantoin and 1,3-
bis(hydroxymethyl)-5,5-dimethylhydantoin intended as a preservative in 
clay-type fillers for paper and paperboard intended in contact with 
aqueous and fatty foods 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 a mixture of 
hydroxymethyl-5,5-dimethylhydantoin and 1,3-bis(hydroxymethyl)-5,5-
dimethylhydantoin may nevertheless be subject to regulation as a 
pesticide under the Federal Insecticide, Fungicide, and Rodenticide Act 
(FIFRA). Therefore, manufacturers intending to market food-contact 
articles containing a mixture of hydroxymethyl-5,5-dimethylhydantoin 
and 1,3-bis(hydroxymethyl)-5,5-dimethylhydantoin for this intended use 
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 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.
    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.

II. Objections

    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 April 28, 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.

III. References

    The following references have been placed on display in the Dockets 
Management Branch (address above) and may be seen by interested persons 
between 9 a.m. and 4 p.m., Monday through Friday.
    1. Soffritti, M., C. Maltoni, F. Maffei, and R. Biagi, 
``Formaldehyde: An Experimental Multipotential Carcinogen,'' Toxicology 
and Industrial Health, vol. 5, No. 5, pp. 699-730, 1989.
    2. Til, H. P., R. A. Woutersen, V. J. Feron, V. H. M. Hollanders, 
H. E. Falke, and J. J. Clary, ``Two-Year Drinking-Water Study of 
Formaldehyde in Rats,'' Food Chemical Toxicology, vol. 27, No. 2, pp. 
77-87, 1989.
    3. Memorandum of Conferences concerning ``Formaldehyde,'' Meeting 
of the Cancer Assessment Committee, FDA, April 24, 1991, and March 4, 
1993.

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, 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 176.170 is amended in the table in paragraph (a)(5) by 
alphabetically adding an entry under the headings ``List of 
Substances'' and ``Limitations'' to read as follows:


Sec. 176.170  Components of paper and paperboard in contact with 
aqueous and fatty foods.

* * * * *
    (a) * * *
    (5) * * *

[[Page 16520]]



 
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         List of Substances                      Limitations
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  *                    *                    *                    *
                   *                    *                    *
Hydroxymethyl-5,5-dimethylhydantoin  For use only as a preservative in
 (CAS Reg. No. 27636-82-4), mixture   clay-type fillers at a level not
 with 1,3-bis(hydroxymethyl)-5,5-     to exceed a combined total of
 dimethylhydantoin (CAS Reg. No.      1,200 milligrams/kilograms
 6440-58-0).                          hydroxymethyl-5,5-
                                      dimethylhydantoin and 1,3-
                                      bis(hydroxymethyl)-5,5-
                                      dimethylhydantoin in the filler.
  *                    *                    *                    *
                   *                    *                    *
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    Dated: March 20, 2000.
Margaret M. Dotzel,
Acting Associate Commissioner for Policy.
[FR Doc. 00-7655 Filed 3-28-00; 8:45 am]
BILLING CODE 4160-01-F