[Federal Register Volume 80, Number 189 (Wednesday, September 30, 2015)]
[Rules and Regulations]
[Pages 58600-58602]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-24795]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 73

[Docket No. FDA-2015-C-1154]


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 certain distilled spirits. This action is in 
response to a color additive petition (CAP) submitted by E. & J. Gallo 
Winery.

DATES: This rule is effective November 2, 2015. See section VIII for 
further information on the filing of objections. Submit either 
electronic or written objections and requests for a hearing by October 
30, 2015.

ADDRESSES: You may submit either electronic or written objections and 
requests for a hearing, identified by Docket No. FDA-2015-C-1154, 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 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-2015-C-1154 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.
    Docket: For access to the docket to read background documents or 
objections received, go to http://www.regulations.gov and insert the 
docket number, 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: Salome Bhagan, Center for Food Safety 
and Applied Nutrition (HFS-265), Food and Drug Administration, 5100 
Paint Branch Pkwy., College Park, MD 20740-3835, 240-402-3041.

SUPPLEMENTARY INFORMATION:

I. Background

    In a notice published in the Federal Register on April 22, 2015 (80 
FR 22449), we announced that we filed a color additive petition (CAP 
5C0302) to amend the color additive regulations in Sec.  73.350 Mica-
based pearlescent pigments (21 CFR 73.350).
    CAP 5C0302 was submitted by E. & J. Gallo Winery, c/o Keller and 
Heckman LLP, Three Embarcadero Center, Suite 1420, San Francisco, CA 
94111 (petitioner). In CAP 5C0302, E. & J. Gallo Winery proposed to 
amend the color additive regulations in Sec.  73.350 to increase the 
maximum permitted alcohol content of distilled spirits to which mica-
based pearlescent pigments may be added from 23 percent to 25 percent 
alcohol by volume, and to remove the current limitation for distilled 
spirits mixtures containing more than 5 percent wine on a proof gallon 
basis. The term ``distilled spirits'' is defined by the Alcohol and 
Tobacco Tax and Trade Bureau as ethyl alcohol, hydrated oxide of ethyl, 
spirits of wine, whisky, rum, brandy, gin, and other distilled spirits, 
including all dilutions and mixtures thereof, for nonindustrial use. 
The term does not include mixtures containing wine, bottled at 48 
degrees of proof or less, if the mixture contains more than 50 percent 
wine on a proof gallon basis (27 CFR 5.11).
    Mica-based pearlescent pigments prepared from titanium dioxide and 
mica are currently approved under Sec.  73.350(c)(1)(i) for use as a 
color additive 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. They are also approved under Sec.  
73.350(c)(1)(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 
(Sec.  73.350(c)(1)(ii)(A)); cordials, liqueurs, flavored alcoholic 
malt beverages, wine coolers, and cocktails (Sec.  
73.350(c)(1)(ii)(B)); and non-alcoholic cocktail mixes and mixers, such 
as margarita mix, Bloody Mary mix, and daiquiri mix, but excluding 
eggnog, tonic water, and beverages that are typically consumed without 
added alcohol (e.g., fruit juices, fruit juice drinks, and soft drinks) 
(Sec.  73.350(c)(1)(ii)(C)). The pigments also are approved under Sec.  
73.350(c)(1)(iii) in egg decorating kits used for coloring the shells 
of eggs in amounts consistent with good manufacturing practice. Mica-
based pearlescent pigments prepared from titanium dioxide on mica, iron 
oxide on mica, and titanium dioxide and iron oxide on mica are approved 
for use as a color additive in ingested drugs under Sec.  73.1350 (21 
CFR 73.1350). Mica-based pearlescent pigments formed by depositing 
titanium or iron salts from a basic solution onto mica, followed by 
calcination to produce titanium dioxide or iron oxides on mica, are 
approved for use in contact lenses under Sec.  73.3128 (21 CFR 
73.3128). The color additive that is mica-based pearlescent pigments 
prepared from titanium dioxide and mica will be referred hereinafter in 
this final rule as mica-based pearlescent pigments.

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 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'' to mean 
that there is 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 not harmful under its intended conditions 
of use, we consider the projected human dietary exposure to the 
additive, the additive's toxicological data, and other relevant 
information (such as published literature) available to us. We compare 
an individual's estimated daily intake (EDI) of the additive from all 
sources to an acceptable daily intake (ADI) 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. We 
typically use the EDI for the 90th percentile consumer of a color 
additive as a

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measure of high chronic dietary exposure.

B. Safety of the Petitioned Use of the Color Additive

    During our safety review of the use of mica-based pearlescent 
pigments proposed in CAP 5C0302, we considered the exposure to the 
color additive from its petitioned use and from the currently permitted 
uses in food and ingested drugs under Sec. Sec.  73.350 and 73.1350, 
respectively. In estimating the cumulative estimated dietary intake 
(CEDI) of these pigments, we determined that the exposure to mica-based 
pearlescent pigments from the use in egg decorating kits used for 
coloring the shells of boiled eggs and in contact lenses (Sec. Sec.  
73.350(c)(1)(iii) and 73.3128, respectively) is negligible and, 
therefore, does not contribute to the exposure.
    The petitioner estimated the eaters-only exposure to mica-based 
pearlescent pigments from the proposed use in distilled spirits 
containing not less than 18 percent and not more than 25 percent 
alcohol by volume at 0.14 grams per person per day (g/p/d) at the mean 
and 0.31 g/p/d at the 90th percentile for the U.S. population (Ref. 1). 
(An eaters-only exposure is the total of the amount of food consumed 
per day averaged over the number of days in the survey period by 
individuals consuming the food at least once during the survey period.) 
We conclude that the petitioner's exposure estimates are sufficiently 
conservative to account for the petitioned use of mica-based 
pearlescent pigments. Regarding cumulative exposure from the current 
and petitioned uses of mica-based pearlescent pigments, we note that in 
our recent final rule that provided for the safe use of mica-based 
pearlescent pigments as color additives in cordials, liqueurs, flavored 
alcoholic malt beverages, wine coolers, cocktails, non-alcoholic 
cocktail mixers and mixes, and in egg decorating kits for coloring 
shell eggs, we estimated the CEDI for the use of mica-based pearlescent 
pigments in food (Sec.  73.350) and ingested drugs (Sec.  73.1350) to 
be 0.25 g/p/d at the mean and 0.50 g/p/d at the 90th percentile for the 
U.S. population (80 FR 32303 at 32305, June 8, 2015). Since the 
petitioned use of mica-based pearlescent pigments will generally 
substitute for currently-permitted uses of mica-based pearlescent 
pigments in other alcoholic beverages with no change in the maximum use 
level of 0.07 percent by weight, we have determined that the petitioned 
use of mica-based pearlescent pigments will not result in an increase 
in consumer exposure to these pigments. Therefore, we conclude that our 
previous CEDI for mica-based pearlescent pigments of 0.25 g/p/d at the 
mean and 0.50 g/p/d at the 90th percentile for the U.S. population will 
remain unchanged (Ref. 1).
    To support the safety of the proposed use of mica-based pearlescent 
pigments in food, the petitioner referenced the safety determination 
made by FDA for previously filed petitions (70 FR 42271, July 22, 
2005); (71 FR 31927, June 2, 2006); and (78 FR 35115, June 12, 2013); 
including our previously established ADI for mica-based pearlescent 
pigments of 1.8 g/p/d based on a 2-year rat carcinogenicity bioassay 
(71 FR 31927 at 31928). Because there is no increase in the intake of 
mica-based pearlescent pigments beyond a level that has already been 
established as safe, FDA has no concerns regarding the petitioned use 
of mica-based pearlescent pigments in distilled spirits containing not 
less than 18 percent and not more than 25 percent alcohol by volume 
(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 25 
percent alcohol by volume, is safe. We further conclude that the 
additive will achieve its intended technical effect and is suitable for 
the petitioned use. Therefore, we are amending the color additive 
regulations in part 73 as set forth in this document. In addition, 
based upon the factors listed in 21 CFR 71.20(b), we conclude that 
certification of mica-based pearlescent pigments prepared from titanium 
dioxide and mica is not necessary for the protection of the public 
health.

IV. Public Disclosure

    In accordance with Sec.  71.15 (21 CFR 71.15), the petitions 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 previously considered the environmental effects of this rule, as 
stated in the April 22, 2015 notice of filing for CAP 5C0302 (80 FR 
22449). We stated that we had determined, under 21 CFR 25.32(k), that 
this action is of a type that does not individually or cumulatively 
have a significant effect on the human environment such that neither an 
environmental assessment nor an environmental impact statement is 
required. We have not received any new information or comments that 
would affect our previous determination.

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 Federal Food, Drug, and Cosmetic Act

    Our 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, 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) to (ll)(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 additive. Accordingly, this final rule should not be 
construed to be a statement that a food containing this 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, except as to 
any provisions that may be stayed by the filing of proper objections. 
If you will be adversely affected by one or more provisions of this 
regulation, you may file with the Division of Dockets Management (see 
ADDRESSES) either electronic or written objections. You must separately 
number each objection, and within each numbered objection you must 
specify with particularity the provision(s) to which you object, and 
the grounds for your objection. Within

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each numbered objection, you must specifically state whether you are 
requesting a hearing on the particular provision that you specify in 
that numbered objection. If you do not request a hearing for any 
particular objection, you waive the right to a hearing on that 
objection. If you request a hearing, your objection must include a 
detailed description and analysis of the specific factual information 
you intend to present in support of the objection in the event that a 
hearing is held. If you do not include such a description and analysis 
for any particular objection, you waive 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. We will publish notice of the objections that we 
have 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.

1. FDA Memorandum from H. Lee, Chemistry Review Group, Division of 
Petition Review, to S. Bhagan, Regulatory Group I, Division of 
Petition Review, May 19, 2015.
2. FDA Memorandum from S. Park, Toxicology Team, Division of 
Petition Review, to S. Bhagan, Regulatory Group I, Division of 
Petition Review, June 8, 2015.

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)(ii)(A) to 
read as follows:


Sec.  73.350  Mica-based pearlescent pigments.

* * * * *
    (c) * * *
    (1) * * *
    (ii) * * *
    (A) Distilled spirits containing not less than 18 percent and not 
more than 25 percent alcohol by volume.
* * * * *

    Dated: September 25, 2015.
Susan Bernard,
Director, Office of Regulations, Policy and Social Sciences, Center for 
Food Safety and Applied Nutrition.
[FR Doc. 2015-24795 Filed 9-29-15; 8:45 am]
 BILLING CODE 4164-01-P