[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]]

=======================================================================
-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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