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Rule: Color Additives: Mica-Based Pearlescent Pigments
Rule: Color Additives: Mica-Based Pearlescent Pigments
to further flight. Do all actions in accordance DEPARTMENT OF HEALTH AND number, found in brackets in the
with the Accomplishment Instructions of HUMAN SERVICES heading of this document, into the
Boeing Special Attention Service Bulletin ‘‘Search’’ box and follow the prompts
747–53–2493, dated July 3, 2003. Food and Drug Administration and/or go to the Division of Dockets
Note 1: For the purposes of this AD, a Management, 5630 Fishers Lane, rm.
detailed inspection is: ‘‘An intensive 21 CFR Part 73 1061, Rockville, MD 20852.
examination of a specific item, installation, [Docket No. 1998C–0431] (formerly 98C– FOR FURTHER INFORMATION CONTACT:
or assembly to detect damage, failure, or 0431) Aydin Örstan, Center for Food Safety
irregularity. Available lighting is normally and Applied Nutrition (HFS–255), Food
supplemented with a direct source of good Listing of Color Additives Exempt from and Drug Administration, 5100 Paint
lighting at an intensity deemed appropriate. Certification; Mica-Based Pearlescent Branch Pkwy., College Park, MD 20740,
Inspection aids such as mirror, magnifying Pigments 301–436–1301.
lenses, etc., may be necessary. Surface
AGENCY: Food and Drug Administration, SUPPLEMENTARY INFORMATION:
cleaning and elaborate procedures may be
required.’’ HHS. I. Introduction
ACTION: Final rule.
Alternative Methods of Compliance In a notice published in the Federal
(AMOCs) SUMMARY: The Food and Drug Register of June 22, 1998 (63 FR 33934),
(g)(1) The Manager, Seattle Aircraft Administration (FDA) is amending the FDA announced that a color additive
Certification Office (ACO), FAA, has the color additive regulations to provide for petition (CAP 8C0257) had been filed by
authority to approve AMOCs for this AD, if the safe use of mica-based pearlescent EM Industries, Inc., 7 Skyline Dr.,
requested in accordance with the procedures pigments as color additives in ingested Hawthorne, NY 10532 (now EMD
found in 14 CFR 39.19. drugs. This action is in response to a Industries, Inc.). The petition proposed
(2) An AMOC that provides an acceptable petition filed by EM Industries, Inc. to amend the color additive regulations
level of safety may be used for any repair DATES: This rule is effective August 23, to provide for the safe use of synthetic
required by this AD, if it is approved by an 2005. Submit written or electronic iron oxide to color ingested drugs at
Authorized Representative for the Boeing objections and requests for a hearing by levels higher than the current limit and
Delegation Option Authorization August 22, 2005. See section VIII of the to provide for the safe use of mica to
Organization who has been authorized by the SUPPLEMENTARY INFORMATION section of color ingested drugs. At the time of the
Manager, Seattle ACO, to make those this document for information on the filing of the petition, FDA considered
findings. For a repair method to be approved, filing of objections. the pigments that are the subjects of this
the repair must meet the certification basis of ADDRESSES: You may submit written or petition to be color additive mixtures of
the airplane, and the approval must electronic objections and requests for a synthetic iron oxide, mica, and titanium
specifically refer to this AD. hearing, identified by Docket No. dioxide. FDA did not include titanium
1998C–0431, by any of the following dioxide in the filing notice, because that
Material Incorporated by Reference color additive was already listed for use
methods:
(h) You must use Boeing Special Attention • Federal eRulemaking Portal: http:// in ingested drugs. During its subsequent
Service Bulletin 747–53–2493, dated July 3, www.regulations.gov. Follow the review of the petition, the agency
2003, to perform the actions that are required determined that these pigments are
instructions for submitting comments.
by this AD, unless the AD specifies • Agency Web site: http:// composite pigments, not color additive
otherwise. The Director of the Federal www.fda.gov/dockets/ecomments. mixtures. Therefore, the agency
Register approves the incorporation by published an amended filing notice in
Follow the instructions for submitting
reference of this document in accordance the Federal Register of June 29, 1999
comments on the agency Web site.
with 5 U.S.C. 552(a) and 1 CFR part 51. To • E-mail: fdadockets@oc.fda.gov. (64 FR 34816), to indicate that the
get copies of the service information, contact petition proposed to amend the color
Include Docket No. 1998C–0431 in the
Boeing Commercial Airplanes, P.O. Box additive regulations to provide for the
subject line of your e-mail message.
3707, Seattle, Washington 98124–2207. To • FAX: 301–827–6870. safe use of composite pigments prepared
view the AD docket, go to the Docket • Mail/Hand delivery/Courier [For from synthetic iron oxide, mica, and
Management Facility, U.S. Department of paper, disk, or CD–ROM submissions]: titanium dioxide to color ingested
Transportation, 400 Seventh Street SW., Division of Dockets Management (HFA– drugs.
room PL–401, Nassif Building, Washington, The petitioner is seeking approval for
305), Food and Drug Administration,
DC. To review copies of the service
5630 Fishers Lane, rm. 1061, Rockville, a maximum use level of the resulting
information, go to the National Archives and
MD 20852. pigments of up to 3 percent by weight
Records Administration (NARA). For
Instructions: All submissions received in the finished drug product, and a
information on the availability of this
must include the agency name and maximum iron oxide content no greater
material at the NARA, call (202) 741–6030,
docket number for this rulemaking. All than 55 percent in those pigments
or go to http://www.archives.gov/federal_
objections received will be posted containing iron oxide.
register/code_of_federal_regulations/ibr_
without change to http://www.fda.gov/
locations.html. II. Manufacturing and Nomenclature
ohrms/dockets/default.htm, including
Issued in Renton, Washington, on July 11, any personal information provided. For The subject color additives are
2005. detailed instructions on submitting manufactured by preparing a
Ali Bahrami, objections, see the ‘‘Objections’’ heading suspension of mica platelets, adding a
Manager, Transport Airplane Directorate, of the SUPPLEMENTARY INFORMATION solution of soluble salts of titanium, of
Aircraft Certification Service. section of this document. iron, or of both, and a base to precipitate
[FR Doc. 05–14174 Filed 7–21–05; 8:45 am] Docket: For access to the docket to titanium hydroxide, iron hydroxide, or
read background documents or both onto the mica platelets. These
BILLING CODE 4910–13–P
comments received, go to http:// particles are then heated (calcined) at
www.fda.gov/ohrms/dockets/ temperatures up to 900 °C. During the
default.htm and insert the docket calcination, titanium hydroxide and
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42272 Federal Register / Vol. 70, No. 140 / Friday, July 22, 2005 / Rules and Regulations
iron hydroxide are converted into IV. Conclusion regulation to which objection is made
titanium dioxide, and iron oxide, Based on the data and information in and the grounds for the objection. Each
respectively. The agency has reviewed the petition and other relevant material, numbered objection on which a hearing
the relevant data and information in the FDA concludes that the petitioned use is requested shall specifically so state.
petition relating to the manufacturing of mica-based pearlescent pigments Failure to request a hearing for any
and identity of the subject color prepared from synthetic iron oxide, particular objection shall constitute a
additives (Ref. 1), and to the proposed mica, and titanium dioxide to color waiver of the right to a hearing on that
uses of and estimated exposures to (Ref. ingested drugs is safe. The agency objection. Each numbered objection for
2) the subject color additives. further concludes that the additives will which a hearing is requested shall
In a final rule published in the achieve their intended technical effect, include a detailed description and
Federal Register of October 24, 2002 (67 and are suitable for use in coloring analysis of the specific factual
FR 65311), the agency listed in ingested drugs. The agency also information intended to be presented in
§ 73.3128 (21 CFR 73.3128) the color concludes that part 73 should be support of the objection in the event
additives based on the first two amended as set forth in this document. that a hearing is held. Failure to include
combinations given above (titanium or In addition, based upon the factors such a description and analysis for any
iron salts and mica platelets) for use in listed in § 71.20(b) (21 CFR 71.20(b)), particular objection shall constitute a
contact lenses. In the same final rule, the agency concludes that certification waiver of the right to a hearing on the
the agency collectively identified these of mica-based pearlescent pigments is objection. Three copies of all documents
color additives as mica-based not necessary for the protection of the are to be submitted and are to be
pearlescent pigments. To be consistent public health. identified with the docket number
with § 73.3128, the agency is using the found in brackets in the heading of this
V. Inspection of Documents
same name for the color additives that document. Any objections received in
are the subjects of the present rule. In accordance with § 71.15, the response to the regulation may be seen
petition and the documents that FDA in the Division of Dockets Management
III. Safety Evaluation considered and relied upon in reaching between 9 a.m. and 4 p.m., Monday
To evaluate the safety of the proposed its decision to approve the petition are through Friday. FDA will publish notice
uses of mica-based pearlescent pigments available for inspection at the Center for of the objections that the agency has
for coloring ingested drugs, the agency Food Safety and Applied Nutrition by received or lack thereof in the Federal
reviewed the toxicological data and appointment with the information Register.
information submitted in the petition as contact person (see FOR FURTHER
well as other information contained in INFORMATION CONTACT). As provided in IX. References
agency files (Ref. 3). In conjunction with § 71.15, the agency will delete from the
documents any materials that are not The following references have been
this review the agency notes that, based placed on display in the Division of
on the chemical nature of these available for public disclosure before
making the documents available for Dockets Management (see ADDRESSES)
inorganic pigments and their individual and may be seen by interested persons
components, as well as the available inspection.
between 9 a.m. and 4 p.m., Monday
solubility data contained in the petition, VI. Environmental Impact through Friday.
the solubility of mica-based pearlescent
The agency has previously considered 1. Jensen, E., Memorandum entitled ‘‘Use
pigments in media relevant to human
the environmental effects of this rule as of Pearlescent Pigments as a Color Additive
health (e.g., digestive fluids in the
announced in the notice of filing for in Tablets and Other Pharmaceutical
gastrointestinal tract) is expected to be
CAP 8C0257 (63 FR 33934). No new Preparations,’’ from the Division of Product
very low. As such, the bioavailability of
information or comments have been Manufacture and Use (HFS–246) to the
these pigments and/or their individual
received that would affect the agency’s Division of Petition Control (HFS–215),
components when ingested is also
previous determination that there is no Center for Food Safety and Applied
expected to be low. Considering the
significant impact on the human Nutrition, FDA, January 21, 1999.
chemical nature of the pigments, and
environment and that an environmental 2. Lee, H. S., Memorandum entitled
their expected low solubility and
impact statement is not required. ‘‘Update of Intake Estimates,’’ from the
bioavailability, the agency concludes
Division of Petition Review (HFS–265) to the
that there is no toxic potential when VII. Paperwork Reduction Act of 1995
Division of Petition Review (HFS–265),
ingested at levels estimated by the This final rule contains no collections Center for Food Safety and Applied
agency, based on their proposed use in of information. Therefore, clearance by Nutrition, FDA, November 24, 2004.
coloring ingested drugs. The agency also the Office of Management and Budget 3. Taras, T. L., Memorandum entitled
notes that it has previously reviewed under the Paperwork Reduction Act of ‘‘Comprehensive Final Toxicology Evaluation
various color additive uses of iron 1995 is not required. Memorandum: CAP 8C0257’’ from the
oxide, titanium dioxide, and mica Division of Petition Review (HFS–265) to the
where the additives would be ingested VIII. Objections
Division of Petition Review (HFS–265),
and found such uses to be safe This rule is effective as shown in the Center for Food Safety and Applied
(§§ 73.200, 73.575, 73.1200, 73.1496, DATES section of this document, except Nutrition, FDA, December 20, 2004.
73.1575, 73.2250, 73.2496, and as to any provisions that may be stayed
73.2575). by the filing of proper objections. Any List of Subjects in 21 CFR Part 73
Therefore, taking into account the person who will be adversely affected
Color additives, Cosmetics, Drugs,
available safety information, the by this regulation may file with the
Medical devices.
insoluble nature of the subject color Division of Dockets Management (see
additives, and the conservative ADDRESSES) written or electronic ■ Therefore, under the Federal Food,
estimates of intake of the additives, the objections. Each objection shall be Drug, and Cosmetic Act and under
agency concludes that the proposed use separately numbered, and each authority delegated to the Commissioner
of mica-based pearlescent pigments to numbered objection shall specify with of Food and Drugs, 21 CFR part 73 is
color ingested drugs is safe (Ref. 3). particularity the provisions of the amended as follows:
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