[Federal Register Volume 64, Number 83 (Friday, April 30, 1999)]
[Rules and Regulations]
[Pages 23185-23186]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-10917]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 74

[Docket No. 98C-0041]


Listing of Color Additives for Coloring Sutures; 
[Phthalocyaninato(2-)] Copper

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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SUMMARY: The Food and Drug Administration (FDA) is amending the color 
additive regulations to provide for the safe use of 
[phthalocyaninato(2-)] copper in coloring nonabsorbable sutures for 
general and ophthalmic surgery made from a blend of poly(vinylidene 
fluoride) and poly(vinylidene fluoride-co-hexafluoropropylene). This 
action responds to a petition filed by Ethicon, Inc.

DATES: This regulation is effective June 2, 1999; except as to any 
provisions that may be stayed by the filing of proper objections; 
written objections and requests for a hearing by June 1, 1999.

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: Ellen M. Waldron, Center for Food 
Safety and Applied Nutrition (HFS-215), 200 C St. SW., Washington, DC 
20204, 202-418-3089.

SUPPLEMENTARY INFORMATION:

I. Introduction

    In a notice published in the Federal Register of February 2, 1998 
(63 FR 5387), FDA announced that a color additive petition (CAP 8C0253) 
had been filed by Ethicon, Inc., P.O. Box 151, Somerville, NJ 08876-
0151. The petition proposed to amend the color additive regulations in 
Sec. 74.3045 [Phthalocyaninato(2-)] copper (21 CFR 74.3045) to provide 
for the safe use of [phthalocyaninato(2-)] copper in coloring 
nonabsorbable sutures for general and ophthalmic surgery made from a 
blend of poly(vinylidene fluoride) and poly(vinylidene fluoride-co-
hexafluoropropylene). The petition was filed under section 721(d)(1) of 
the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 
379e(d)(1)).

II. Applicability of the Act

    With the passage of the Medical Device Amendments of 1976 (Pub. L. 
94-295), Congress mandated the listing of color additives for use in 
medical devices when the color additive in the device comes into direct 
contact with the body for a significant period of time (section 
721(d)(1) of the act). [Phthalocyaninato(2-)] copper is added to 
nonabsorbable sutures made from a blend of poly(vinylidene fluoride) 
and poly(vinylidene fluoride-co-hexafluoropropylene) in such a way that 
at least some of the color additive will come into contact with the 
body when the sutures are in place. In addition, the sutures are 
intended to remain in the body at least until healing is complete. 
Thus, the color additive will be in direct contact with the body for a 
significant period of time. Consequently, the petitioned use of the 
color additive is subject to the statutory listing requirement.

III. Safety of the Petitioned Use of the Additive

    Based on data submitted in the petition and from other relevant 
information, FDA concludes that the petitioned use of the additive, 
[phthalocyaninato(2-)] copper, will result in exposure to no greater 
than 7.5 milligrams (mg) per person over a 70-year lifetime or 0.31 
microgram per person per day (Ref. 1).
    To establish that the color additive [phthalocyaninato(2)-] copper 
is safe for use in coloring sutures made from a blend of 
poly(vinylidene fluoride) and poly(vinylidene fluoride-co-
hexafluoropropylene), the petitioner conducted eight biocompatibility 
tests on the colored sutures or their extracts to evaluate the toxicity 
of the subject color additive. Based on an evaluation of these tests, 
the agency concludes that the colored sutures or their extracts are 
noncytotoxic, nonpyrogenic, and nonirritating.
    Based on the available toxicity data, the small amount of 
[phthalocyaninato(2)-] copper used to the color sutures, and the 
agency's exposure calculation for the proposed use of the subject 
additive, FDA finds that [phthalocyaninato(2)-] copper is safe for use 
in coloring sutures made from a blend of poly(vinylidene fluoride) and 
poly(vinylidene fluoride-co-hexafluoropropylene).

IV. Specifications and Certification

    [Phthalocyaninato(2-)] copper is currently produced as a certified 
color additive for use in coloring contact lenses and certain sutures 
for general and ophthalmic surgery in accordance with 21 CFR part 80. 
The agency concludes that the specifications listed in Sec. 74.3045 for 
these uses are adequate to ensure the safe use of this color additive 
in sutures for general and ophthalmic surgery that are made from a 
blend of poly(vinylidene fluoride) and poly(vinylidene fluoride-co-
hexafluoropropylene).

V. Conclusions on Safety

    FDA has evaluated the data and information in the petition and 
other relevant material. Based on this information the agency concludes 
that: (1) The proposed use of [phthalocyaninato(2-)] copper, at a level 
not to exceed 0.5 percent by weight of the suture material, for 
coloring sutures made from a blend of poly(vinylidene fluoride) and 
poly(vinylidene fluoride-co-hexafluoropropylene) is safe; and (2) the 
color additive will achieve its intended coloring effect, and thus, is 
suitable for this use. Further, the agency concluded that the color 
additive regulations in Sec. 74.3045 should be amended as set forth 
below.

VI. Inspection of Documents

    In accordance with Sec. 71.15 (21 CFR 71.15), 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 (address above) by appointment with 
the information contact person listed above. As provided in Sec. 71.15, 
the agency will delete from the documents any materials that are not 
available for public disclosure before making the documents available 
for inspection.

VII. Environmental Impact

    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.

VIII. Paperwork Reduction Act of 1995

    This final rule contains no collections of information. Therefore, 
clearance by

[[Page 23186]]

the Office of Management and Budget under the Paperwork Reduction Act 
of 1995 is not required.

IX. Objections

    Any person who will be adversely affected by this regulation may at 
any time on or before June 1, 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. FDA will publish 
notice of the objections that the agency has received or lack thereof 
in the Federal Register.

X. Reference

    The following reference has 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. Memorandum from the Division of Product Manufacture and Use, 
Chemistry Review Team, FDA, to the Division of Petition Control, 
FDA, concerning ``CAP 8C0253 (MATS M2.0 & 2.1): Ethicon, Inc. 
(Submission of November 26, 1997). Petition for the safe use of use 
of [sic] phthalocyaninato(2-) copper as a colorant for nonabsorbable 
sutures,'' dated January 26, 1998.

List of Subjects in 21 CFR Part 74

    Color additives, Cosmetics, Drugs.
    Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Food and Drugs, 21 CFR part 
74 is amended as follows:

PART 74--LISTING OF COLOR ADDITIVES SUBJECT TO CERTIFICATION

    1. The authority citation for 21 CFR part 74 continues to read as 
follows:

    Authority: 21 U.S.C. 321, 341, 342, 343, 348, 351, 352, 355, 
361, 362, 371, 379e.

    2. Section 74.3045 is amended by revising the introductory text of 
paragraph (c)(1) to read as follows:


Sec. 74.3045  [Phthalocyaninato(2-)] copper.

* * * * *
    (c) Uses and restrictions. (1) The color additive 
[phthalocyaninato(2-)] copper may be safely used to color polypropylene 
sutures, polybutester (the generic designation for the suture 
fabricated from 1,4-benzenedicarboxylic acid, polymer with 1,4-
butanediol and alpha-hydro-omega- hydroxypoly(oxy-1,4-butanediyl), CAS 
Reg. No. 37282-12-5) nonabsorbable sutures for use in general and 
ophthalmic surgery, polybutylene terephthalate nonabsorbable 
monofilament sutures for general and ophthalmic surgery, nonabsorbable 
sutures made from poly(vinylidene fluoride) and poly(vinylidene 
fluoride-co-hexafluoropropylene) for general and ophthalmic surgery, 
and polymethylmethacrylate monofilament used as supporting haptics for 
intraocular lenses, subject to the following restrictions:
* * * * *

    Dated: April 23, 1999.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 99-10917 Filed 4-29-99; 8:45 am]
BILLING CODE 4160-01-F