[Federal Register Volume 78, Number 113 (Wednesday, June 12, 2013)]
[Rules and Regulations]
[Pages 35115-35117]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-13857]
[[Page 35115]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 73
[Docket No. FDA-2012-C-0224]
Listing of Color Additives Exempt From Certification; Mica-Based
Pearlescent Pigments
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule.
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SUMMARY: The Food and Drug Administration (FDA or we) is amending the
color additive regulations to provide for the safe use of mica-based
pearlescent pigments prepared from titanium dioxide and mica as color
additives in distilled spirits containing not less than 18 percent and
not more than 23 percent alcohol by volume but not including distilled
spirits mixtures containing more than 5 percent wine on a proof gallon
basis. This action is in response to a petition filed by E. & J. Gallo
Winery.
DATES: This rule is effective July 15, 2013. See section VIII for
further information on the filing of objections. Submit either
electronic or written objections and requests for a hearing by July 12,
2013.
ADDRESSES: You may submit either electronic or written objections and
requests for a hearing identified by Docket No. FDA-2012-C-0224, by any
of the following methods:
Electronic Submissions
Submit electronic objections in the following way:
Federal eRulemaking Portal: http://www.regulations.gov.
Follow the instructions for submitting comments.
Written Submissions
Submit written objections in the following ways:
Mail/Hand delivery/Courier (for paper or CD-ROM
submissions): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
Instructions: All submissions received must include the Agency name
and Docket No. FDA-2012-C-0224 for this rulemaking. All objections
received will be posted without change to http://www.regulations.gov,
including any personal information provided. For detailed instructions
on submitting objections, see the ``Objections'' heading of the
SUPPLEMENTARY INFORMATION section of this document.
Docket: For access to the docket to read background documents or
objections received, go to http://www.regulations.gov and insert the
docket number(s), found in brackets in the heading of this document,
into the ``Search'' box and follow the prompts and/or go to the
Division of Dockets Management, 5630 Fishers Lane, Rm. 1061, Rockville,
MD 20852.
FOR FURTHER INFORMATION CONTACT: Raphael A. Davy, Center for Food
Safety and Applied Nutrition (HFS-265), Food and Drug Administration,
5100 Paint Branch Pkwy., College Park, MD 20740-3835, 240-402-1272.
SUPPLEMENTARY INFORMATION:
I. Background
In a document published in the Federal Register of March 22, 2012
(77 FR 16784), FDA announced that a color additive petition (CAP
2C0294) had been filed by E. & J. Gallo Winery, c/o Keller and Heckman
LLP, One Embarcadero Center, Suite 2110, San Francisco, CA 94111. The
petition proposed to amend the color additive regulations in Sec.
73.350 (21 CFR 73.350) Mica-based pearlescent pigments, to provide for
the safe use of mica-based pearlescent pigments prepared from titanium
dioxide and mica in distilled spirits containing not less than 18
percent and not more than 23 percent alcohol by volume but not
including distilled spirits mixtures containing more than 5 percent
wine on a proof gallon basis. The maximum use level of the pigments
proposed by the petitioner is 0.07 percent by weight in the distilled
spirits. Mica-based pearlescent pigments prepared from titanium dioxide
and mica are currently permitted under Sec. 73.350 for use as color
additives in amounts up to 1.25 percent by weight in cereals,
confections and frostings, gelatin deserts, hard and soft candies
(including lozenges), nutritional supplement tablets and gelatin
capsules, and chewing gum. Mica-based pearlescent pigments prepared
from titanium dioxide, iron oxide, and mica are permitted for use as
color additives in ingested drugs under Sec. 73.1350 (21 CFR 73.1350)
and in contact lenses under 21 CFR 73.3128.
II. Safety Evaluation
A. Determination of Safety
Under section 721(b)(4) of the Federal Food, Drug, and Cosmetic Act
(the FD&C Act) (21 U.S.C. 379e(b)(4)), a color additive cannot be
listed for a particular use unless a fair evaluation of the data and
information available to FDA establishes that the color additive is
safe for that use. FDA's color additive regulations in 21 CFR 70.3(i)
define ``safe'' as the existence of ``convincing evidence that
establishes with reasonable certainty that no harm will result from the
intended use of the color additive.''
To establish with reasonable certainty that a color additive
intended for use in food is safe under its intended conditions of use,
we consider the projected human dietary intake of the additive,
toxicological data on the additive, and other relevant information
available to us. We compare an individual's estimated daily intake
(EDI) of the additive from all sources for both the mean and high-
intake consumer to an acceptable daily intake (ADI) level established
by toxicological data. The EDI is determined by projections based on
the amount of the additive proposed for use in particular foods and on
data regarding the amount consumed from all sources of the additive.
B. Safety of the Petitioned Use of the Color Additive
During our review of the safety of the petitioned use of mica-based
pearlescent pigments in distilled spirits, we considered the exposure
to the color additive from both its petitioned use and from the uses
for which it is currently permitted in food and ingested drugs under
Sec. Sec. 73.350 and 73.1350, respectively. In estimating the
cumulative exposure to these pigments, we also considered the exposure
to these pigments from their uses in contact lenses and determined that
such exposure would be negligible.
For those consuming mica-based pearlescent pigments from the
petitioned use in distilled spirits, we have estimated the exposure to
mica-based pearlescent pigments at the mean and at the 90th percentile
to be 0.12 grams/person/day (g/p/d) and 0.25 g/p/d, respectively, for
persons aged 2 years or more (Ref. 1).
Previously, in the issuance of Sec. 73.350 we calculated a
cumulative EDI (CEDI) for the use of mica-based pearlescent pigments in
food (Sec. 73.350) and ingested drugs (Sec. 73.1350) (71 FR 31927,
June 2, 2006). For those exposed to mica-based pearlescent pigments
from their use in food and ingested drugs, the CEDI was estimated to be
0.24 g/p/d and 0.48 g/p/d at the mean and at the 90th percentile,
respectively, for persons aged 2 years or more, and to be 0.26 g/p/d
and 0.52 g/p/d at the mean and at the 90th percentile, respectively,
for the subgroup of children aged 2 to 5 years (71 FR 31927). This
exposure estimate used food consumption data from the 1994 to 1996 and
1998 Continuing Survey of Food Intakes by Individuals
[[Page 35116]]
(CSFII) survey, which was integrated into the National Health and
Nutrition Examination Survey (NHANES) in 2002.
In our current safety assessment, we updated the previous exposure
to mica-based pearlescent pigments from all regulated uses in foods
using the latest publicly available NHANES food consumption data (2003
to 2008). In estimating the exposure from the use of mica-based
pearlescent pigments in ingested drugs, we relied on the estimates used
in the issuance of Sec. 73.350 (71 FR 31927). The current CEDI of
mica-based pearlescent pigments from the petitioned use in distilled
spirits and its regulated uses in food and ingested drugs is 0.26 g/p/d
at the mean and 0.52 g/p/d at the 90th percentile for persons aged 2
years or more, and also for the subgroup of children aged 2 to 5 years
(Ref. 1). The current CEDIs of mica-based pearlescent pigments are not
significantly different from the previous CEDIs, as the percent of the
population consuming distilled spirits from the petitioned use is low
compared to the percent of the population consuming foods and ingested
drugs formulated with mica-based pearlescent pigments. Further, our
estimate assumes no contribution from the petitioned use of mica-based
pearlescent pigments to the CEDI for the subgroup of children aged 2 to
5 years because they do not typically consume distilled spirits (Ref.
1).
In our previous safety evaluation of mica-based pearlescent
pigments in food, which the petitioner referenced, we established an
ADI level for mica-based pearlescent pigments to be 1.8 g/p/d based on
a 2-year rat carcinogenicity bioassay that tested a 1:1 blend of mica
and titanium dioxide (71 FR 31927 at 31928). Since the CEDI is less
than the ADI, we conclude that the proposed expanded use of mica-based
pearlescent pigments as color additives at a level of up to 0.07
percent by weight in distilled spirits is safe (Ref. 2).
III. Conclusion
Based on the data and information in the petition and other
relevant material, FDA concludes that the petitioned use of mica-based
pearlescent pigments prepared from titanium dioxide and mica as a color
additive at a level of up to 0.07 percent by weight in distilled
spirits containing not less than 18 percent and not more than 23
percent alcohol by volume but not including distilled spirits mixtures
containing more than 5 percent wine on a proof gallon basis is safe. We
further conclude that the additive will achieve its intended technical
effect and is suitable for use in coloring food. Therefore, we conclude
that the color additive regulations should be amended as set forth in
this document. In addition, based upon the factors listed in 21 CFR
71.20(b), we conclude that certification of titanium dioxide-coated
mica-based pearlescent pigments is not necessary for the protection of
the public health.
IV. Public Availability of Documents
In accordance with Sec. 71.15 (21 CFR 71.15), the petition and the
documents that we considered and relied upon in reaching our decision
to approve the petition will be made available for public disclosure
(see FOR FURTHER INFORMATION CONTACT). As provided in Sec. 71.15, we
will delete from the documents any materials that are not available for
public disclosure.
V. Environmental Impact
We have previously considered the environmental effects of this
rule as announced in the notice of filing for CAP 2C0294 (77 FR 16784,
March 22, 2012). No new information or comments have been received that
would affect our previous determination that there is no significant
impact on the human environment and that an environmental impact
statement is not required.
VI. Paperwork Reduction Act of 1995
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.
VII. Section 301(ll) of the FD&C Act
FDA's review of this petition was limited to section 721 of the
FD&C Act. This final rule is not a statement regarding compliance with
other sections of the FD&C Act. For example, the Food and Drug
Administration Amendments Act of 2007, which was signed into law on
September 27, 2007, amended the FD&C Act to, among other things, add
section 301(ll) of the FD&C Act (21 U.S.C. 331(ll)). Section 301(ll) of
the FD&C Act prohibits the introduction or delivery for introduction
into interstate commerce of any food that contains a drug approved
under section 505 of the FD&C Act (21 U.S.C. 355), a biological product
licensed under section 351 of the Public Health Service Act (42 U.S.C.
262), or a drug or biological product for which substantial clinical
investigations have been instituted and their existence has been made
public, unless one of the exemptions in section 301(ll)(1)-(4) of the
FD&C Act applies. In our review of this petition, we did not consider
whether section 301(ll) of the FD&C Act or any of its exemptions apply
to food containing this color additive. Accordingly, this final rule
should not be construed to be a statement that a food containing this
color additive, if introduced or delivered for introduction into
interstate commerce, would not violate section 301(ll) of the FD&C Act.
Furthermore, this language is included in all color additive final
rules that pertain to food and therefore should not be construed to be
a statement of the likelihood that section 301(ll) of the FD&C Act
applies.
VIII. Objections
This rule is effective as shown in the DATES section of this
document; except as to any provisions that may be stayed by the filing
of proper objections. Any person who will be adversely affected by this
regulation may file with the Division of Dockets Management (see
ADDRESSES) either electronic or written objections regarding this
document. 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. It is
only necessary to send one set of documents. Identify documents 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 Division of Dockets Management between 9 a.m. and 4 p.m., Monday
through Friday, and will be posted to the docket at http://www.regulations.gov. FDA will publish notice of the objections that the
Agency has received or lack thereof in the Federal Register.
IX. References
The following references have been placed on display in the
Division of Dockets Management (see ADDRESSES) and may be seen by
interested persons between 9 a.m. and 4 p.m., Monday through Friday,
and are available electronically at http://www.regulations.gov.
[[Page 35117]]
1. Memorandum from Hyoung S. Lee, Division of Petition Review,
Chemistry Review Team, to Raphael Davy, Division of Petition Review,
Regulatory Group I, May 30, 2012.
2. Memorandum from Tina W. Walker, Division of Petition Review,
Toxicology Team, to Raphael Davy, Division of Petition Review,
Regulatory Group I, October 3, 2012.
List of Subjects in 21 CFR Part 73
Color additives, Cosmetics, Drugs, Medical devices.
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 73 is amended as follows:
PART 73--LISTING OF COLOR ADDITIVES EXEMPT FROM CERTIFICATION
0
1. The authority citation for 21 CFR part 73 continues to read as
follows:
Authority: 21 U.S.C. 321, 341, 342, 343, 348, 351, 352, 355,
361, 362, 371, 379e.
0
2. Section 73.350 is amended by revising paragraph (c)(1) to read as
follows:
Sec. 73.350 Mica-based pearlescent pigments.
* * * * *
(c) * * *
(1) The substance listed in paragraph (a) of this section may be
safely used as a color additive in food as follows:
(i) In amounts up to 1.25 percent, by weight, in the following
foods: Cereals, confections and frostings, gelatin desserts, hard and
soft candies (including lozenges), nutritional supplement tablets and
gelatin capsules, and chewing gum.
(ii) In amounts up to 0.07 percent, by weight, in distilled spirits
containing not less than 18 percent and not more than 23 percent
alcohol by volume but not including distilled spirits mixtures
containing more than 5 percent wine on a proof gallon basis.
* * * * *
Dated: June 6, 2013.
Susan M. Bernard,
Director, Office of Regulations, Policy and Social Sciences, Center for
Food Safety and Applied Nutrition.
[FR Doc. 2013-13857 Filed 6-11-13; 8:45 am]
BILLING CODE 4160-01-P