[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]
=======================================================================
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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) * * *
------------------------------------------------------------------------
List of substances Limitations
------------------------------------------------------------------------
* * * *
* * *
(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.
------------------------------------------------------------------------
* * * * *
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
