[Federal Register Volume 64, Number 10 (Friday, January 15, 1999)]
[Rules and Regulations]
[Pages 2567-2568]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-902]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 175

[Docket No. 96F-0136]


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 silver chloride-
coated titanium dioxide as a preservative in polymeric coatings for 
polyolefin films intended for use in contact with food. This action is 
in response to a petition filed by Johnson Matthey Chemicals.

DATES: The regulation is effective January 15, 1999; written objections 
and requests for a hearing by Febraury 16, 1999.

ADDRESSES: Submit written objections to the Dockets Management Branch 
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1601, 
Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Vir D. Anand, Center for Food Safety 
and Applied Nutrition (HFS-215), 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 May 10, 1996 (61 FR 21473), FDA announced that a food 
additive petition (FAP 6B4503) had been filed by Johnson Matthey 
Chemicals, c/o Technical Assessment Systems, Inc., The Flour Mill, 1000 
Potomac St. NW., Washington, DC 20007. The petition proposed to amend 
the food additive regulations in Sec. 175.320 Resinous and polymeric 
coatings for polyolefin films (21 CFR 175.320) to provide for the safe 
use of silver chloride-coated titanium dioxide as a preservative in 
polymeric coatings for polyolefin films 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 
additive is safe, (2) the food additive will have the intended 
technical effect, and (3) the regulations in Sec. 175.320 should be 
amended as set forth below.
    Silver chloride-coated titanium dioxide intended for use as a 
preservative in polymeric coatings for polyolefin films intended for 
use in contact with 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 silver chloride-coated 
titanium dioxide 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 silver chloride-coated titanium dioxide 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.
    Any person who will be adversely affected by this regulation may at 
any

[[Page 2568]]

time on or before Febraury 16, 1999, 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:

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: 21 U.S.C. 321, 342, 348, 379e.

    2. Section 175.320 is amended in the table in paragraph (b)(3) by 
adding entry ``(iv)'' to read as follows:

Sec. 175.320  Resinous and polymeric coatings for polyolefin films.

* * * * *
    (b) * * *
    (3) * * *

 
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           List of substances                      Limitations
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  *                    *                    *                    *
                   *                    *                    *
(iv) Preservatives:
    Silver chloride-coated titanium      For use only as a preservative
 dioxide..                                in latex emulsions at a level
                                          not to exceed 2.2 parts per
                                          million (based on silver ion
                                          concentration) in the dry
                                          coating.
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* * * * *

    Dated: January 7, 1999.
L. Robert Lake,
Director, Office of Policy, Planning and Strategic Initiatives, Center 
for Food Safety and Applied Nutrition.
[FR Doc. 99-902 Filed 1-14-99; 8:45 am]
BILLING CODE 4160-01-F