80_FR_32412 80 FR 32303 - Listing of Color Additives Exempt From Certification; Mica-Based Pearlescent Pigments

80 FR 32303 - Listing of Color Additives Exempt From Certification; Mica-Based Pearlescent Pigments

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 80, Issue 109 (June 8, 2015)

Page Range32303-32307
FR Document2015-13834

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 cordials, liqueurs, flavored alcoholic malt beverages, wine coolers, cocktails, non-alcoholic cocktail mixers and mixes, and in egg decorating kits for coloring shell eggs. This action is in response to two color additive petitions (CAPs) submitted separately by EMD Millipore Corp. and by Signature Brands, LLC.

Federal Register, Volume 80 Issue 109 (Monday, June 8, 2015) 
[Federal Register Volume 80, Number 109 (Monday, June 8, 2015)]
[Rules and Regulations]
[Pages 32303-32307]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-13834]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 73

[Docket Nos. FDA-2014-C-1616 and FDA-2015-C-0245]


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 cordials, liqueurs, flavored alcoholic malt 
beverages, wine coolers, cocktails, non-alcoholic cocktail mixers and 
mixes, and in egg decorating kits for coloring shell eggs. This action 
is in response to two color additive petitions (CAPs) submitted 
separately by EMD Millipore Corp. and by Signature Brands, LLC.

DATES: This rule is effective July 9, 2015. See section VIII for 
further information on the filing of objections. Submit either 
electronic or written objections and requests for a hearing by July 8, 
2015.

ADDRESSES: You may submit either electronic or written objections and 
requests for a hearing identified by Docket No. FDA-2014-C-1616 (Mica-
based pearlescent pigments in cordials, liqueurs, flavored alcoholic 
malt beverages, wine coolers, cocktails, non-alcoholic cocktail mixers 
and mixes) or Docket No. FDA-2015-C-0245 (Mica-based pearlescent 
pigments in egg decorating kits), 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 submissions): 
Division of Dockets Management (HFA-305), Food and Drug

[[Page 32304]]

Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
    Instructions: All submissions received must include the Agency name 
and Docket No. FDA-2014-C-1616 (Mica-based pearlescent pigments in 
cordials, liqueurs, flavored alcoholic malt beverages, wine coolers, 
cocktails, non-alcoholic cocktail mixers and mixes) or Docket No. FDA-
2015-C-0245 (Mica-based pearlescent pigments in egg decorating kits) 
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 numbers, 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: Ellen Anderson, Center for Food Safety 
and Applied Nutrition (HFS-265), Food and Drug Administration, 5100 
Paint Branch Pkwy., College Park, MD 20740-3835, 240-402-1309.

SUPPLEMENTARY INFORMATION: 

I. Background

    In notices published in the Federal Register on October 21, 2014, 
and February 5, 2015 (79 FR 62932 and 80 FR 6468, respectively), we 
announced that we filed CAPs (4C0299 and 5C0301, respectively) to amend 
the color additive regulations in Sec.  73.350 Mica-based pearlescent 
pigments (21 CFR 73.350).
    CAP 4C0299 was submitted by EMD Millipore Corp. (EMD), c/o Hyman, 
Phelps & McNamara, P.C., 700 13th St. NW., Suite 1200, Washington, DC 
20005. CAP 4C0299 proposed to amend the color additive regulations in 
Sec.  73.350 to expand the safe use of mica-based pearlescent pigments 
prepared from titanium dioxide and mica as a color additive in 
cordials, liqueurs, cocktails, and certain other alcoholic beverages, 
and non-alcoholic cocktail mixers and mixes. The maximum use level of 
the pigments proposed by the petitioner is 0.07 percent by weight in 
the beverages, mixers, and mixes, consistent with approval in Sec.  
73.350(c)(1)(ii) for the use of mica-based pearlescent pigments 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. 
In correspondence with FDA, EMD subsequently refined the petitioned use 
of mica-based pearlescent pigments to cordials, liqueurs, flavored 
alcoholic malt beverages, wine coolers, cocktails, and non-alcoholic 
cocktail mixers and mixes.
    CAP 5C0301 was submitted by Signature Brands, LLC, c/o Keller and 
Heckman, LLP, 1001 G St. NW., Suite 500 West, Washington, DC 20001. CAP 
5C0301 proposed to amend Sec.  73.350 to provide for the safe use of 
mica-based pearlescent pigments prepared from titanium dioxide and mica 
in egg decorating kits for coloring boiled shell eggs, in amounts 
consistent with good manufacturing practice (GMP).
    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. Mica-based pearlescent pigments prepared 
from titanium dioxide and mica are also currently 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. 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 
specified uses 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 specified uses in contact lenses under Sec.  
73.3128 (21 CFR 73.3128). The color additive that is the subject of the 
two color additive petitions at issue, 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 establish 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 
food 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 food sources of the additive. We 
typically use the EDI for the 90th percentile consumer of a color 
additive as a measure of high chronic dietary exposure.

B. Petitioned Uses of the Color Additive

    In CAP 4C0299, EMD proposed to amend the color additive regulations 
in Sec.  73.350 to provide for the safe use of mica-based pearlescent 
pigments as a color additive in amounts up to 0.07 percent, by weight, 
in cordials, liqueurs, flavored alcoholic malt beverages, wine coolers, 
cocktails, and non-alcoholic cocktail mixes and mixers. According to 
the standards of identity for distilled spirits regulations issued by 
the Alcohol and Tobacco Tax and Trade Bureau (TTB), which regulates the 
labeling of certain alcoholic beverages, cordials and liqueurs are a 
class of distilled spirits obtained by mixing or redistilling distilled 
spirits with or over fruits, flowers, plants, or pure juices therefrom, 
or other natural flavoring materials, or with extracts derived from 
infusions, percolation, or maceration of such materials, and containing 
sugar, dextrose, or levulose, or a combination thereof, in an amount 
not less than 2\1/2\ percent by weight of the finished product (27 CFR 
5.22(h)). Neither FDA nor TTB has a regulatory definition for 
``cocktail.'' The petition defines cocktails as ``products that are 
sold as mixtures of distilled spirits and non-alcoholic ingredients.'' 
Subsequent communication with the petitioner clarified that the 
following are descriptions of the types of cocktail products included 
within the scope of the petition: (1) Cocktails containing

[[Page 32305]]

one or more alcoholic beverages and one or more non-alcoholic mixers 
(e.g., margarita, gin and tonic, cosmopolitan, fuzzy navel, Bloody 
Mary, caipirinha, Irish coffee, Long Island iced tea, daiquiri, 
hurricane); (2) cocktails containing one or more alcoholic beverages 
without non-alcoholic mixers (e.g., vodka martini, stinger, black 
Russian, Manhattan); (3) cocktails containing beer (e.g., caipbeerinha, 
boilermaker, beer Bloody Mary); (4) cocktails containing wine (e.g., 
mimosa, Kir Royale, wine cooler, wine spritzer); and (5) non-alcoholic 
mixes and mixers for use in cocktails (e.g., margarita mix, daiquiri 
mix, Bloody Mary mix). We note that mica-based pearlescent pigments are 
intended to be used in both liquid and powdered forms of non-alcoholic 
cocktail mixes and mixers, at a maximum use level of 0.07 percent by 
weight of the mix or mixer (Ref. 1). Furthermore, only non-alcoholic 
mixes and mixers that are marketed specifically for use in cocktails, 
such as margarita mix and Bloody Mary mix, are included within the 
scope of this petition (Ref. 1). Beverages that are typically consumed 
without added alcohol (e.g., fruit juices, carbonated water, soft 
drinks) are outside the scope of this petition. The petition also 
proposed to amend Sec.  73.350 to provide for the safe use of mica-
based pearlescent pigments in flavored alcoholic malt beverages and 
wine coolers. Like ``cocktail,'' the term ``wine cooler'' does not have 
a regulatory definition. According to TTB, products traditionally known 
as wine coolers have generally been replaced in recent years by 
flavored alcoholic malt beverages, which are manufactured with a malt 
base rather than with wine (Ref. 1). Flavored alcoholic malt beverages 
are sold under many proprietary names and include alcoholic lemonades, 
alcoholic colas, and other flavored alcoholic beverages (see 70 FR 194 
at 195 (January 3, 2005) (TTB final rule pertaining to ``Flavored Malt 
Beverage and Related Regulatory Amendments'')). Products marketed as 
wine coolers and flavored alcoholic malt beverages are included in the 
scope of the petition to amend the color additive regulations in Sec.  
73.350. Traditional malt beverages, such as beer, ale, and malt liquor, 
differ substantially from flavored alcoholic malt beverages (see 70 FR 
194) and are not included within the scope of the petition. Wine, which 
has a standard of identity defined under TTB's regulations at 27 CFR 
part 4, subpart C, is also outside the scope of the petition. 
Furthermore, the petitioner clarified that the scope of the petition 
does not include sangria, which is typically a mixture of wine, fruit, 
and other ingredients.
    In CAP 5C0301, Signature Brands, LLC proposed to amend the color 
additive regulations in Sec.  73.350 to provide for the safe use of 
mica-based pearlescent pigments as a color additive in egg decorating 
kits to color the shells of boiled eggs in amounts consistent with GMP. 
The petitioner proposed to use mica-based pearlescent pigments in a 
packet of glaze that is part of egg decorating kits sold for in-home 
use. According to the kit instructions, the glaze containing the mica-
based pearlescent pigments is intended to be rubbed on the shells of 
colored boiled eggs to impart a metallic sheen.

C. Safety of the Petitioned Uses of the Color Additive

    During our safety review of the uses of mica-based pearlescent 
pigments proposed in CAPs 4C0299 and 5C0301, we considered the exposure 
to the color additive from its petitioned uses 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 contact lenses (Sec.  
73.3128) is negligible and, therefore, need not be included in our 
exposure estimate. Furthermore, we concluded that the exposure to the 
additive from the petitioned use in coloring the shells of boiled eggs 
is also negligible. In CAP 5C0301, the petitioner noted that, because 
eggshells are not consumed, exposure to mica-based pearlescent pigments 
would be limited to the amount of additive that migrates through the 
shell and the inner membrane that separates the shell from the edible 
egg. The petitioner asserted that, given the pigments' relatively large 
particle size and insolubility in food, the amount of mica-based 
pearlescent pigments that could actually be found in the edible portion 
of the egg is insignificant. The petitioner provided a conservative 
estimate for potential exposure to the additive from the petitioned use 
based on a worst-case scenario that presumed the theoretical maximum 
solubility of mica-based pearlescent pigments is equivalent to that of 
mica (80 milligrams/kilograms in 10 percent acetic acid). Exposure to 
mica-based pearlescent pigments from decorated eggshells is likely 
further reduced by the typically limited seasonal availability of the 
egg decorating kits. We agree with the rationale proposed in CAP 5C0301 
that the exposure to the additive from the petitioned use is 
negligible, and that the petitioned use would not result in a 
significant contribution to the CEDI for mica-based pearlescent 
pigments (Ref. 2).
    We estimate the eaters-only exposure to mica-based pearlescent 
pigments from the proposed uses in cordials, liqueurs, flavored 
alcoholic malt beverages, wine coolers, cocktails, and non-alcoholic 
cocktail mixers and mixes for the U.S. population to be 0.15 grams/
person/day (g/p/d) at the mean and 0.34 g/p/d at the 90th percentile 
(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.) In a previous amendment to Sec.  73.350 (78 FR 35115 at 35115 
and 35116 (June 12, 2013)), we estimated a CEDI for the use of mica-
based pearlescent pigments in food (Sec.  73.350) and ingested drugs 
(Sec.  73.1350) using food consumption data from the 2003 to 2008 
National Health and Nutrition Examination Survey (NHANES). In our 
current safety assessment, we updated the previous exposure to mica-
based pearlescent pigments from all approved uses in foods using NHANES 
food consumption data from 2007 to 2010. In estimating the exposure to 
mica-based pearlescent pigments from the use in ingested drugs, we 
relied on the estimates used in a previous safety evaluation (Ref. 1). 
The updated eaters-only CEDI of mica-based pearlescent pigments, 
including the petitioned use in cordials, liqueurs, flavored alcoholic 
malt beverages, wine coolers, cocktails, and non-alcoholic cocktail 
mixers and mixes, and the currently approved uses in food and ingested 
drugs, is 0.25 g/p/d at the mean and 0.50 g/p/d at the 90th percentile 
for the U.S. population (Ref. 1). The updated CEDIs for mica-based 
pearlescent pigments are not significantly different from the previous 
CEDIs (78 FR 35115 at 35116). This is not unexpected, as both the 
previous and updated exposure estimates were based on a similar set of 
NHANES food codes that included cordials, liqueurs, and cocktails (Ref. 
1). In addition, the percent of the population consuming alcoholic 
beverages from the petitioned use is significantly lower compared to 
the proportion of the population that consumes foods and ingested drugs 
containing mica-based pearlescent pigments, thereby resulting in a 
smaller contribution to the CEDI (Ref. 1).
    To support the safety of the proposed uses of mica-based 
pearlescent pigments in food, the petitioners of CAPs 4C0299 and 5C0301 
referenced the safety

[[Page 32306]]

determination made by FDA for previously filed petitions (70 FR 42271 
(July 22, 2005); 71 FR 31927 (June 2, 2006); and 78 FR 35115). In a 
prior safety evaluation, we concluded that the bioavailability of 
ingested mica-based pearlescent pigments and/or their individual 
components is expected to be low based on the chemical nature of these 
inorganic pigments and their individual components and the low 
solubility of mica-based pearlescent pigments in media relevant to 
human health (e.g., digestive fluids in the gastrointestinal tract) (70 
FR 42271 at 42272). We are not aware of any new studies on the 
bioavailability of mica-based pearlescent pigments published since our 
previous evaluation (70 FR 42271). As part of our current safety 
evaluation, we also reviewed several recent studies on titanium 
dioxide, which is a component of mica-based pearlescent pigments, to 
further clarify the extent of the color additive's bioavailability. We 
determined that the new information on titanium dioxide supports our 
previous conclusion that mica-based pearlescent pigments are not 
bioavailable to any significant extent upon ingestion (Ref. 3).
    In our previous safety evaluation, which the petitioners 
referenced, we established an ADI for mica-based pearlescent pigments 
to be 1.8 g/p/d based on a 2-year rat carcinogenicity bioassay (71 FR 
31927 at 31928). Since the updated CEDI (0.50 g/p/d at the 90th 
percentile) for mica-based pearlescent pigments for the U.S. population 
is less than the ADI, we conclude that the proposed expanded use of 
mica-based pearlescent pigments as a color additive at levels of up to 
0.07 percent by weight in cordials, liqueurs, flavored alcoholic malt 
beverages, wine coolers, cocktails, and non-alcoholic cocktail mixers 
and mixes is safe (Ref. 3). We also conclude that the proposed expanded 
use of mica-based pearlescent pigments in egg decorating kits to color 
the shells of eggs at levels consistent with GMP is safe, since the 
exposure to mica-based pearlescent pigments contributed by this use is 
negligible (Ref. 3).

III. Conclusion

    Based on the data and information in the petitions 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 levels of up to 0.07 percent by weight in cordials, 
liqueurs, flavored alcoholic malt beverages, wine coolers, cocktails, 
and non-alcoholic cocktail mixers and mixes is safe. We also conclude 
that the petitioned use of mica-based pearlescent pigments prepared 
from titanium dioxide and mica as a color additive in egg decorating 
kits used to color the shells of eggs in amounts consistent with GMP is 
safe. We further conclude that the additive will achieve its intended 
technical effect and is suitable for the petitioned uses. Therefore, we 
are amending the color additive regulations in part 73 (21 CFR 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 titanium 
dioxide-coated mica-based pearlescent pigments 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 petitions 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 October 21, 2014, and February 5, 2015, notices of filing 
for CAPs 4C0299 and 5C0301 (79 FR 62932 and 80 FR 6468, respectively). 
For CAP 4C0299, 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. For CAP 5C0301, we stated that we had 
determined, under Sec.  25.32(r), 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 
determinations.

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 these petitions 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 (21 U.S.C. 331(ll) 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 (4) of the FD&C Act applies. In our review of these 
petitions, 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 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

[[Page 32307]]

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 E. Anderson, Regulatory Group II, Division of 
Petition Review, January 5, 2015.
2. FDA Memorandum from H. Lee, Chemistry Review Group, Division of 
Petition Review, to E. Anderson, Regulatory Group II, Division of 
Petition Review, March 13, 2015.
3. FDA Memorandum from S. Park, Toxicology Team, Division of 
Petition Review, to E. Anderson, Regulatory Group II, Division of 
Petition Review, March 18, 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) and by 
adding paragraph (c)(1)(iii) to read as follows:


Sec.  73.350  Mica-based pearlescent pigments.

* * * * *
    (c) * * *
    (1) * * *
    (ii) In amounts up to 0.07 percent, by weight, in the following:
    (A) 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.
    (B) Cordials, liqueurs, flavored alcoholic malt beverages, wine 
coolers, and cocktails.
    (C) 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).
    (iii) In egg decorating kits used for coloring the shells of eggs 
in amounts consistent with good manufacturing practice.
* * * * *

    Dated: June 2, 2015.
Susan Bernard,
Director, Office of Regulations, Policy and Social Sciences, Center for 
Food Safety and Applied Nutrition.
[FR Doc. 2015-13834 Filed 6-5-15; 8:45 am]
 BILLING CODE 4164-01-P

Federal Register / Vol. 80, No. 109 / Monday, June 8, 2015 / Rules and Regulations 32303 AIRAC date State City Airport FDC No. FDC date Subject 25–Jun–15 ........ OH Cambridge ................ Cambridge Muni ....... 5/7977 05/13/15 VOR–A, Amdt 4. 25–Jun–15 ........ OH Cambridge ................ Cambridge Muni ....... 5/7979 05/13/15 LOC/DME Rwy 22, Amdt 1B. 25–Jun–15 ........ OH Cambridge ................ Cambridge Muni ....... 5/7981 05/13/15 RNAV (GPS) Rwy 4, Orig-A. 25–Jun–15 ........ OH Tiffin .......................... Seneca County ......... 5/8225 05/12/15 NDB Rwy 24, Amdt 7B. 25–Jun–15 ........ FL Hollywood ................. North Perry ............... 5/8526 05/13/15 RNAV (GPS) Rwy 10R, Orig-A. 25–Jun–15 ........ FL Hollywood ................. North Perry ............... 5/8528 05/13/15 RNAV (GPS) Rwy 28R, Orig-A. 25–Jun–15 ........ GA Vidalia ....................... Vidalia Rgnl .............. 5/8557 05/08/15 ILS OR LOC/NDB Rwy 24, Amdt 1. 25–Jun–15 ........ NM Alamogordo .............. Alamogordo-White 5/8653 05/13/15 VOR Rwy 3, Amdt 2A. Sands Rgnl. 25–Jun–15 ........ NM Alamogordo .............. Alamogordo-White 5/8654 05/13/15 RNAV (GPS) Rwy 3, Orig-A. Sands Rgnl. 25–Jun-15 ......... NM Alamogordo .............. Alamogordo-White 5/8655 05/13/15 VOR/DME Rwy 3, Orig-A. Sands Rgnl. 25–Jun–15 ........ TX Nacogdoches ............ A L Mangham Jr 5/8755 05/13/15 ILS OR LOC Rwy 36, Amdt 3B. Rgnl. 25–Jun–15 ........ MI Sault Ste Marie ......... Chippewa County Intl 5/8758 05/12/15 ILS OR LOC Rwy 16, Amdt 8B. 25–Jun–15 ........ IL Chicago/Prospect Chicago Executive .... 5/8761 05/13/15 ILS OR LOC Rwy 16, Amdt 2C. Heights/Wheeling. 25–Jun–15 ........ OK Tulsa ......................... Tulsa Intl ................... 5/8766 05/13/15 VOR/DME Rwy 8, Amdt 4A. 25–Jun–15 ........ KY Somerset .................. Lake Cumberland 5/8799 05/13/15 ILS OR LOC/DME Rwy 5, Orig-B. Rgnl. 25–Jun–15 ........ KY Somerset .................. Lake Cumberland 5/8800 05/13/15 RNAV (GPS) Y Rwy 5, Amdt 3. Rgnl. 25–Jun–15 ........ MN Ely ............................. Ely Muni .................... 5/9087 05/13/15 RNAV (GPS) Rwy 12, Amdt 1A. 25–Jun–15 ........ MN Silver Bay ................. Silver Bay Muni ........ 5/9407 05/13/15 NDB Rwy 25, Orig. 25–Jun–15 ........ MN Silver Bay ................. Silver Bay Muni ........ 5/9419 05/13/15 RNAV (GPS) Rwy 25, Orig. 25–Jun–15 ........ TX Weslaco .................... Mid Valley ................. 5/9422 05/13/15 GPS Rwy 13, Orig-A. 25–Jun–15 ........ TX Weslaco .................... Mid Valley ................. 5/9423 05/13/15 VOR/DME–A, Orig. 25–Jun–15 ........ IL Paxton ...................... Paxton ...................... 5/9445 05/13/15 RNAV (GPS) Rwy 18, Orig. 25–Jun–15 ........ IL Paxton ...................... Paxton ...................... 5/9446 05/13/15 VOR Rwy 18, Amdt 2. 25–Jun–15 ........ LA Winnfield ................... David G Joyce .......... 5/9450 05/13/15 RNAV (GPS) Rwy 27, Orig. 25–Jun–15 ........ LA Winnfield ................... David G Joyce .......... 5/9451 05/13/15 RNAV (GPS) Rwy 9, Orig-A. 25–Jun–15 ........ IA Chariton .................... Chariton Muni ........... 5/9553 05/13/15 RNAV (GPS) Rwy 10, Orig. 25–Jun–15 ........ IA Chariton .................... Chariton Muni ........... 5/9554 05/13/15 RNAV (GPS) Rwy 17, Amdt 1A. 25–Jun–15 ........ OH Cincinnati .................. Cincinnati Muni Air- 5/9719 05/13/15 ILS OR LOC Rwy 21L, Amdt 19. port Lunken Field. 25–Jun–15 ........ OH Cincinnati .................. Cincinnati Muni Air- 5/9720 05/13/15 NDB Rwy 21L, Amdt 17A. port Lunken Field. 25–Jun–15 ........ OH Cincinnati .................. Cincinnati Muni Air- 5/9721 05/13/15 RNAV (GPS) Rwy 21L, Amdt 1B. port Lunken Field. 25–Jun–15 ........ OH Cincinnati .................. Cincinnati Muni Air- 5/9722 05/13/15 NDB Rwy 25, Amdt 12A. port Lunken Field. 25–Jun–15 ........ OH Cincinnati .................. Cincinnati Muni Air- 5/9723 05/13/15 LOC BC Rwy 3R, Amdt 8D. port Lunken Field. 25–Jun–15 ........ OH Cincinnati .................. Cincinnati Muni Air- 5/9724 05/13/15 RNAV (GPS) Rwy 25, Amdt 1A. port Lunken Field. [FR Doc. 2015–13824 Filed 6–5–15; 8:45 am] amending the color additive regulations Docket No. FDA–2014–C–1616 (Mica- BILLING CODE 4910–13–P to provide for the safe use of mica-based based pearlescent pigments in cordials, pearlescent pigments prepared from liqueurs, flavored alcoholic malt titanium dioxide and mica as color beverages, wine coolers, cocktails, non- DEPARTMENT OF HEALTH AND additives in cordials, liqueurs, flavored alcoholic cocktail mixers and mixes) or HUMAN SERVICES alcoholic malt beverages, wine coolers, Docket No. FDA–2015–C–0245 (Mica- cocktails, non-alcoholic cocktail mixers based pearlescent pigments in egg Food and Drug Administration and mixes, and in egg decorating kits for decorating kits), by any of the following coloring shell eggs. This action is in methods: 21 CFR Part 73 response to two color additive petitions Electronic Submissions [Docket Nos. FDA–2014–C–1616 and FDA– (CAPs) submitted separately by EMD Millipore Corp. and by Signature Submit electronic objections in the 2015–C–0245] Brands, LLC. following way: Listing of Color Additives Exempt • Federal eRulemaking Portal: http:// DATES: This rule is effective July 9, From Certification; Mica-Based www.regulations.gov. Follow the 2015. See section VIII for further wreier-aviles on DSK5TPTVN1PROD with RULES Pearlescent Pigments instructions for submitting comments. information on the filing of objections. AGENCY: Food and Drug Administration, Submit either electronic or written Written Submissions HHS. objections and requests for a hearing by Submit written objections in the July 8, 2015. following ways: ACTION: Final rule. ADDRESSES: You may submit either • Mail/Hand delivery/Courier (for SUMMARY: The Food and Drug electronic or written objections and paper submissions): Division of Dockets Administration (‘‘FDA’’ or ‘‘we’’) is requests for a hearing identified by Management (HFA–305), Food and Drug VerDate Sep<11>2014 15:05 Jun 05, 2015 Jkt 235001 PO 00000 Frm 00037 Fmt 4700 Sfmt 4700 E:\FR\FM\08JNR1.SGM 08JNR1

32304 Federal Register / Vol. 80, No. 109 / Monday, June 8, 2015 / Rules and Regulations Administration, 5630 Fishers Lane, Rm. percent and not more than 23 percent additive cannot be listed for a particular 1061, Rockville, MD 20852. alcohol by volume, but not including use unless the data and information Instructions: All submissions received distilled spirits mixtures containing available to FDA establish that the color must include the Agency name and more than 5 percent wine on a proof additive is safe for that use. FDA’s color Docket No. FDA–2014–C–1616 (Mica- gallon basis. In correspondence with additive regulations in 21 CFR 70.3(i) based pearlescent pigments in cordials, FDA, EMD subsequently refined the define ‘‘safe’’ to mean that there is liqueurs, flavored alcoholic malt petitioned use of mica-based pearlescent convincing evidence that establishes beverages, wine coolers, cocktails, non- pigments to cordials, liqueurs, flavored with reasonable certainty that no harm alcoholic cocktail mixers and mixes) or alcoholic malt beverages, wine coolers, will result from the intended use of the Docket No. FDA–2015–C–0245 (Mica- cocktails, and non-alcoholic cocktail color additive. To establish with based pearlescent pigments in egg mixers and mixes. reasonable certainty that a color decorating kits) for this rulemaking. All CAP 5C0301 was submitted by additive intended for use in food is not objections received will be posted Signature Brands, LLC, c/o Keller and harmful under its intended conditions without change to http:// Heckman, LLP, 1001 G St. NW., Suite of use, we consider the projected human www.regulations.gov, including any 500 West, Washington, DC 20001. CAP dietary exposure to the additive, the personal information provided. For 5C0301 proposed to amend § 73.350 to additive’s toxicological data, and other detailed instructions on submitting provide for the safe use of mica-based relevant information (such as published objections, see the ‘‘Objections’’ heading pearlescent pigments prepared from literature) available to us. We compare of the SUPPLEMENTARY INFORMATION titanium dioxide and mica in egg an individual’s estimated daily intake section. decorating kits for coloring boiled shell (EDI) of the additive from all food Docket: For access to the docket to eggs, in amounts consistent with good sources to an acceptable daily intake read background documents or manufacturing practice (GMP). (ADI) established by toxicological data. objections received, go to http:// Mica-based pearlescent pigments The EDI is determined by projections www.regulations.gov and insert the prepared from titanium dioxide and based on the amount of the additive docket numbers, found in brackets in mica are currently approved under proposed for use in particular foods and the heading of this document, into the § 73.350(c)(1)(i) for use as a color on data regarding the amount consumed ‘‘Search’’ box and follow the prompts additive in amounts up to 1.25 percent from all food sources of the additive. We and/or go to the Division of Dockets by weight in cereals, confections and typically use the EDI for the 90th Management, 5630 Fishers Lane, Rm. frostings, gelatin deserts, hard and soft percentile consumer of a color additive 1061, Rockville, MD 20852. candies (including lozenges), nutritional as a measure of high chronic dietary FOR FURTHER INFORMATION CONTACT: supplement tablets and gelatin capsules, exposure. Ellen Anderson, Center for Food Safety and chewing gum. Mica-based B. Petitioned Uses of the Color Additive and Applied Nutrition (HFS–265), Food pearlescent pigments prepared from titanium dioxide and mica are also In CAP 4C0299, EMD proposed to and Drug Administration, 5100 Paint amend the color additive regulations in Branch Pkwy., College Park, MD 20740– currently approved under § 73.350(c)(1)(ii) in amounts up to 0.07 § 73.350 to provide for the safe use of 3835, 240–402–1309. mica-based pearlescent pigments as a percent, by weight, in distilled spirits SUPPLEMENTARY INFORMATION: color additive in amounts up to 0.07 containing not less than 18 percent and I. Background not more than 23 percent alcohol by percent, by weight, in cordials, liqueurs, volume, but not including distilled flavored alcoholic malt beverages, wine In notices published in the Federal coolers, cocktails, and non-alcoholic Register on October 21, 2014, and spirits mixtures containing more than 5 percent wine on a proof gallon basis. cocktail mixes and mixers. According to February 5, 2015 (79 FR 62932 and 80 the standards of identity for distilled FR 6468, respectively), we announced Mica-based pearlescent pigments spirits regulations issued by the Alcohol that we filed CAPs (4C0299 and 5C0301, prepared from titanium dioxide on and Tobacco Tax and Trade Bureau respectively) to amend the color mica, iron oxide on mica, and titanium (TTB), which regulates the labeling of additive regulations in § 73.350 Mica- dioxide and iron oxide on mica are certain alcoholic beverages, cordials and based pearlescent pigments (21 CFR approved for specified uses as a color liqueurs are a class of distilled spirits 73.350). additive in ingested drugs under obtained by mixing or redistilling CAP 4C0299 was submitted by EMD § 73.1350 (21 CFR 73.1350). Mica-based distilled spirits with or over fruits, Millipore Corp. (EMD), c/o Hyman, pearlescent pigments formed by flowers, plants, or pure juices therefrom, Phelps & McNamara, P.C., 700 13th St. depositing titanium or iron salts from a or other natural flavoring materials, or NW., Suite 1200, Washington, DC basic solution onto mica, followed by with extracts derived from infusions, 20005. CAP 4C0299 proposed to amend calcination to produce titanium dioxide percolation, or maceration of such the color additive regulations in or iron oxides on mica, are approved for materials, and containing sugar, § 73.350 to expand the safe use of mica- specified uses in contact lenses under dextrose, or levulose, or a combination based pearlescent pigments prepared § 73.3128 (21 CFR 73.3128). The color thereof, in an amount not less than 21⁄2 from titanium dioxide and mica as a additive that is the subject of the two percent by weight of the finished color additive in cordials, liqueurs, color additive petitions at issue, mica- product (27 CFR 5.22(h)). Neither FDA cocktails, and certain other alcoholic based pearlescent pigments prepared nor TTB has a regulatory definition for beverages, and non-alcoholic cocktail from titanium dioxide and mica, will be ‘‘cocktail.’’ The petition defines mixers and mixes. The maximum use referred hereinafter in this final rule as cocktails as ‘‘products that are sold as wreier-aviles on DSK5TPTVN1PROD with RULES level of the pigments proposed by the mica-based pearlescent pigments. mixtures of distilled spirits and non- petitioner is 0.07 percent by weight in II. Safety Evaluation alcoholic ingredients.’’ Subsequent the beverages, mixers, and mixes, communication with the petitioner consistent with approval in A. Determination of Safety clarified that the following are § 73.350(c)(1)(ii) for the use of mica- Under section 721(b)(4) of the Federal descriptions of the types of cocktail based pearlescent pigments in distilled Food, Drug, and Cosmetic Act (the products included within the scope of spirits containing not less than 18 FD&C Act) (21 U.S.C. 379e(b)(4)), a color the petition: (1) Cocktails containing VerDate Sep<11>2014 15:05 Jun 05, 2015 Jkt 235001 PO 00000 Frm 00038 Fmt 4700 Sfmt 4700 E:\FR\FM\08JNR1.SGM 08JNR1

Federal Register / Vol. 80, No. 109 / Monday, June 8, 2015 / Rules and Regulations 32305 one or more alcoholic beverages and one include sangria, which is typically a the exposure to the additive from the or more non-alcoholic mixers (e.g., mixture of wine, fruit, and other petitioned use is negligible, and that the margarita, gin and tonic, cosmopolitan, ingredients. petitioned use would not result in a fuzzy navel, Bloody Mary, caipirinha, In CAP 5C0301, Signature Brands, significant contribution to the CEDI for Irish coffee, Long Island iced tea, LLC proposed to amend the color mica-based pearlescent pigments (Ref. daiquiri, hurricane); (2) cocktails additive regulations in § 73.350 to 2). containing one or more alcoholic provide for the safe use of mica-based We estimate the eaters-only exposure beverages without non-alcoholic mixers pearlescent pigments as a color additive to mica-based pearlescent pigments (e.g., vodka martini, stinger, black in egg decorating kits to color the shells from the proposed uses in cordials, Russian, Manhattan); (3) cocktails of boiled eggs in amounts consistent liqueurs, flavored alcoholic malt containing beer (e.g., caipbeerinha, with GMP. The petitioner proposed to beverages, wine coolers, cocktails, and boilermaker, beer Bloody Mary); (4) use mica-based pearlescent pigments in non-alcoholic cocktail mixers and mixes cocktails containing wine (e.g., mimosa, a packet of glaze that is part of egg for the U.S. population to be 0.15 grams/ Kir Royale, wine cooler, wine spritzer); decorating kits sold for in-home use. person/day (g/p/d) at the mean and 0.34 and (5) non-alcoholic mixes and mixers According to the kit instructions, the g/p/d at the 90th percentile (Ref. 1). (An for use in cocktails (e.g., margarita mix, glaze containing the mica-based eaters-only exposure is the total of the daiquiri mix, Bloody Mary mix). We pearlescent pigments is intended to be amount of food consumed per day note that mica-based pearlescent rubbed on the shells of colored boiled averaged over the number of days in the pigments are intended to be used in eggs to impart a metallic sheen. survey period by individuals consuming the food at least once during the survey both liquid and powdered forms of non- C. Safety of the Petitioned Uses of the period.) In a previous amendment to alcoholic cocktail mixes and mixers, at Color Additive § 73.350 (78 FR 35115 at 35115 and a maximum use level of 0.07 percent by During our safety review of the uses 35116 (June 12, 2013)), we estimated a weight of the mix or mixer (Ref. 1). of mica-based pearlescent pigments CEDI for the use of mica-based Furthermore, only non-alcoholic mixes proposed in CAPs 4C0299 and 5C0301, pearlescent pigments in food (§ 73.350) and mixers that are marketed we considered the exposure to the color and ingested drugs (§ 73.1350) using specifically for use in cocktails, such as additive from its petitioned uses and food consumption data from the 2003 to margarita mix and Bloody Mary mix, are from the currently permitted uses in 2008 National Health and Nutrition included within the scope of this food and ingested drugs under §§ 73.350 Examination Survey (NHANES). In our petition (Ref. 1). Beverages that are and 73.1350, respectively. In estimating current safety assessment, we updated typically consumed without added the cumulative estimated dietary intake the previous exposure to mica-based alcohol (e.g., fruit juices, carbonated (CEDI) of these pigments, we pearlescent pigments from all approved water, soft drinks) are outside the scope determined that the exposure to mica- uses in foods using NHANES food of this petition. The petition also based pearlescent pigments from the use consumption data from 2007 to 2010. In proposed to amend § 73.350 to provide in contact lenses (§ 73.3128) is estimating the exposure to mica-based for the safe use of mica-based negligible and, therefore, need not be pearlescent pigments from the use in pearlescent pigments in flavored included in our exposure estimate. ingested drugs, we relied on the alcoholic malt beverages and wine Furthermore, we concluded that the estimates used in a previous safety coolers. Like ‘‘cocktail,’’ the term ‘‘wine exposure to the additive from the evaluation (Ref. 1). The updated eaters- cooler’’ does not have a regulatory petitioned use in coloring the shells of only CEDI of mica-based pearlescent definition. According to TTB, products boiled eggs is also negligible. In CAP pigments, including the petitioned use traditionally known as wine coolers 5C0301, the petitioner noted that, in cordials, liqueurs, flavored alcoholic have generally been replaced in recent because eggshells are not consumed, malt beverages, wine coolers, cocktails, years by flavored alcoholic malt exposure to mica-based pearlescent and non-alcoholic cocktail mixers and beverages, which are manufactured with pigments would be limited to the mixes, and the currently approved uses a malt base rather than with wine (Ref. amount of additive that migrates in food and ingested drugs, is 0.25 g/p/ 1). Flavored alcoholic malt beverages through the shell and the inner d at the mean and 0.50 g/p/d at the 90th are sold under many proprietary names membrane that separates the shell from percentile for the U.S. population (Ref. and include alcoholic lemonades, the edible egg. The petitioner asserted 1). The updated CEDIs for mica-based alcoholic colas, and other flavored that, given the pigments’ relatively large pearlescent pigments are not alcoholic beverages (see 70 FR 194 at particle size and insolubility in food, significantly different from the previous 195 (January 3, 2005) (TTB final rule the amount of mica-based pearlescent CEDIs (78 FR 35115 at 35116). This is pertaining to ‘‘Flavored Malt Beverage pigments that could actually be found in not unexpected, as both the previous and Related Regulatory Amendments’’)). the edible portion of the egg is and updated exposure estimates were Products marketed as wine coolers and insignificant. The petitioner provided a based on a similar set of NHANES food flavored alcoholic malt beverages are conservative estimate for potential codes that included cordials, liqueurs, included in the scope of the petition to exposure to the additive from the and cocktails (Ref. 1). In addition, the amend the color additive regulations in petitioned use based on a worst-case percent of the population consuming § 73.350. Traditional malt beverages, scenario that presumed the theoretical alcoholic beverages from the petitioned such as beer, ale, and malt liquor, differ maximum solubility of mica-based use is significantly lower compared to substantially from flavored alcoholic pearlescent pigments is equivalent to the proportion of the population that malt beverages (see 70 FR 194) and are that of mica (80 milligrams/kilograms in wreier-aviles on DSK5TPTVN1PROD with RULES consumes foods and ingested drugs not included within the scope of the 10 percent acetic acid). Exposure to containing mica-based pearlescent petition. Wine, which has a standard of mica-based pearlescent pigments from pigments, thereby resulting in a smaller identity defined under TTB’s decorated eggshells is likely further contribution to the CEDI (Ref. 1). regulations at 27 CFR part 4, subpart C, reduced by the typically limited To support the safety of the proposed is also outside the scope of the petition. seasonal availability of the egg uses of mica-based pearlescent pigments Furthermore, the petitioner clarified decorating kits. We agree with the in food, the petitioners of CAPs 4C0299 that the scope of the petition does not rationale proposed in CAP 5C0301 that and 5C0301 referenced the safety VerDate Sep<11>2014 15:05 Jun 05, 2015 Jkt 235001 PO 00000 Frm 00039 Fmt 4700 Sfmt 4700 E:\FR\FM\08JNR1.SGM 08JNR1

32306 Federal Register / Vol. 80, No. 109 / Monday, June 8, 2015 / Rules and Regulations determination made by FDA for pigments prepared from titanium This final rule is not a statement previously filed petitions (70 FR 42271 dioxide and mica as a color additive in regarding compliance with other (July 22, 2005); 71 FR 31927 (June 2, egg decorating kits used to color the sections of the FD&C Act. For example, 2006); and 78 FR 35115). In a prior shells of eggs in amounts consistent section 301(ll) of the FD&C Act (21 safety evaluation, we concluded that the with GMP is safe. We further conclude U.S.C. 331(ll) prohibits the introduction bioavailability of ingested mica-based that the additive will achieve its or delivery for introduction into pearlescent pigments and/or their intended technical effect and is suitable interstate commerce of any food that individual components is expected to be for the petitioned uses. Therefore, we contains a drug approved under section low based on the chemical nature of are amending the color additive 505 of the FD&C Act (21 U.S.C. 355), a these inorganic pigments and their regulations in part 73 (21 CFR part 73) biological product licensed under individual components and the low as set forth in this document. In section 351 of the Public Health Service solubility of mica-based pearlescent addition, based upon the factors listed Act (42 U.S.C. 262), or a drug or pigments in media relevant to human in 21 CFR 71.20(b), we conclude that biological product for which substantial health (e.g., digestive fluids in the certification of titanium dioxide-coated clinical investigations have been gastrointestinal tract) (70 FR 42271 at mica-based pearlescent pigments is not instituted and their existence has been 42272). We are not aware of any new necessary for the protection of the made public, unless one of the studies on the bioavailability of mica- public health. exemptions in section 301(ll)(1) to (4) of based pearlescent pigments published the FD&C Act applies. In our review of since our previous evaluation (70 FR IV. Public Disclosure these petitions, we did not consider 42271). As part of our current safety In accordance with § 71.15 (21 CFR whether section 301(ll) of the FD&C Act evaluation, we also reviewed several 71.15), the petitions and the documents or any of its exemptions apply to food recent studies on titanium dioxide, that we considered and relied upon in containing this additive. Accordingly, which is a component of mica-based reaching our decision to approve the this final rule should not be construed pearlescent pigments, to further clarify petitions will be made available for to be a statement that a food containing the extent of the color additive’s public disclosure (see FOR FURTHER this additive, if introduced or delivered bioavailability. We determined that the INFORMATION CONTACT). As provided in for introduction into interstate new information on titanium dioxide § 71.15, we will delete from the commerce, would not violate section supports our previous conclusion that documents any materials that are not 301(ll) of the FD&C Act. Furthermore, mica-based pearlescent pigments are not available for public disclosure. this language is included in all color bioavailable to any significant extent additive final rules that pertain to food upon ingestion (Ref. 3). V. Environmental Impact and therefore should not be construed to In our previous safety evaluation, We previously considered the be a statement of the likelihood that which the petitioners referenced, we environmental effects of this rule, as section 301(ll) of the FD&C Act applies. established an ADI for mica-based stated in the October 21, 2014, and pearlescent pigments to be 1.8 g/p/d February 5, 2015, notices of filing for VIII. Objections based on a 2-year rat carcinogenicity CAPs 4C0299 and 5C0301 (79 FR 62932 This rule is effective as shown in the bioassay (71 FR 31927 at 31928). Since and 80 FR 6468, respectively). For CAP DATES section, except as to any the updated CEDI (0.50 g/p/d at the 90th 4C0299, we stated that we had provisions that may be stayed by the percentile) for mica-based pearlescent determined, under 21 CFR 25.32(k), that filing of proper objections. If you will be pigments for the U.S. population is less this action is of a type that does not adversely affected by one or more than the ADI, we conclude that the individually or cumulatively have a provisions of this regulation, you may proposed expanded use of mica-based significant effect on the human file with the Division of Dockets pearlescent pigments as a color additive environment such that neither an Management (see ADDRESSES) either at levels of up to 0.07 percent by weight environmental assessment nor an electronic or written objections. You in cordials, liqueurs, flavored alcoholic environmental impact statement is must separately number each objection, malt beverages, wine coolers, cocktails, required. For CAP 5C0301, we stated and within each numbered objection and non-alcoholic cocktail mixers and that we had determined, under you must specify with particularity the mixes is safe (Ref. 3). We also conclude § 25.32(r), that this action is of a type provision(s) to which you object, and that the proposed expanded use of mica- that does not individually or the grounds for your objection. Within based pearlescent pigments in egg cumulatively have a significant effect on each numbered objection, you must decorating kits to color the shells of eggs the human environment such that specifically state whether you are at levels consistent with GMP is safe, neither an environmental assessment requesting a hearing on the particular since the exposure to mica-based nor an environmental impact statement provision that you specify in that pearlescent pigments contributed by is required. We have not received any numbered objection. If you do not this use is negligible (Ref. 3). new information or comments that request a hearing for any particular would affect our previous objection, you waive the right to a III. Conclusion hearing on that objection. If you request determinations. Based on the data and information in a hearing, your objection must include the petitions and other relevant VI. Paperwork Reduction Act of 1995 a detailed description and analysis of material, FDA concludes that the This final rule contains no collection the specific factual information you petitioned use of mica-based pearlescent of information. Therefore, clearance by intend to present in support of the pigments prepared from titanium wreier-aviles on DSK5TPTVN1PROD with RULES the Office of Management and Budget objection in the event that a hearing is dioxide and mica as a color additive at under the Paperwork Reduction Act of held. If you do not include such a levels of up to 0.07 percent by weight 1995 is not required. description and analysis for any in cordials, liqueurs, flavored alcoholic particular objection, you waive the right malt beverages, wine coolers, cocktails, VII. Section 301(ll) of the Federal Food, to a hearing on the objection. and non-alcoholic cocktail mixers and Drug, and Cosmetic Act It is only necessary to send one set of mixes is safe. We also conclude that the Our review of these petitions was documents. Identify documents with the petitioned use of mica-based pearlescent limited to section 721 of the FD&C Act. docket number found in brackets in the VerDate Sep<11>2014 15:05 Jun 05, 2015 Jkt 235001 PO 00000 Frm 00040 Fmt 4700 Sfmt 4700 E:\FR\FM\08JNR1.SGM 08JNR1

Federal Register / Vol. 80, No. 109 / Monday, June 8, 2015 / Rules and Regulations 32307 heading of this document. Any 23 percent alcohol by volume but not Administration, 10903 New Hampshire objections received in response to the including distilled spirits mixtures Ave., Bldg. 66, Rm. 1234, Silver Spring, regulation may be seen in the Division containing more than 5 percent wine on MD 20993, 301–796–6326, of Dockets Management between 9 a.m. a proof gallon basis. fernando.aguel@fda.hhs.gov. and 4 p.m., Monday through Friday, and (B) Cordials, liqueurs, flavored SUPPLEMENTARY INFORMATION: will be posted to the docket at http:// alcoholic malt beverages, wine coolers, www.regulations.gov. We will publish and cocktails. I. Background—Regulatory Authorities notice of the objections that we have (C) Non-alcoholic cocktail mixes and The Federal Food, Drug, and Cosmetic received or lack thereof in the Federal mixers, such as margarita mix, Bloody Act (the FD&C Act), as amended by the Register. Mary mix, and daiquiri mix, but Medical Device Amendments of 1976 excluding eggnog, tonic water, and (the 1976 amendments) (Pub. L. 94– IX. References beverages that are typically consumed 295), the Safe Medical Devices Act of The following references have been without added alcohol (e.g., fruit juices, 1990 (Pub. L. 101–629), the Food and placed on display in the Division of fruit juice drinks, and soft drinks). Drug Administration Modernization Act Dockets Management (see ADDRESSES) (iii) In egg decorating kits used for of 1997 (FDAMA) (Pub. L. 105–115), the and may be seen by interested persons coloring the shells of eggs in amounts Medical Device User Fee and between 9 a.m. and 4 p.m., Monday consistent with good manufacturing Modernization Act of 2002 (Pub. L. 107– through Friday, and are available practice. 250), the Medical Devices Technical electronically at http:// * * * * * Corrections Act (Pub. L. 108–214), the www.regulations.gov. Food and Drug Administration Dated: June 2, 2015. 1. FDA Memorandum from H. Lee, Chemistry Amendments Act of 2007 (Pub. L. 110– Susan Bernard, 85), and the Food and Drug Review Group, Division of Petition Director, Office of Regulations, Policy and Administration Safety and Innovation Review, to E. Anderson, Regulatory Social Sciences, Center for Food Safety and Act (FDASIA) (Pub. L. 112–144), among Group II, Division of Petition Review, Applied Nutrition. January 5, 2015. other amendments, established a 2. FDA Memorandum from H. Lee, Chemistry [FR Doc. 2015–13834 Filed 6–5–15; 8:45 am] comprehensive system for the regulation Review Group, Division of Petition BILLING CODE 4164–01–P of medical devices intended for human Review, to E. Anderson, Regulatory use. Section 513 of the FD&C Act (21 Group II, Division of Petition Review, U.S.C. 360c) established three categories March 13, 2015. DEPARTMENT OF HEALTH AND (classes) of devices, reflecting the 3. FDA Memorandum from S. Park, HUMAN SERVICES Toxicology Team, Division of Petition regulatory controls needed to provide Review, to E. Anderson, Regulatory reasonable assurance of their safety and Food and Drug Administration Group II, Division of Petition Review, effectiveness. The three categories of March 18, 2015. devices are class I (general controls), 21 CFR Part 870 class II (special controls), and class III List of Subjects in 21 CFR Part 73 [Docket No. FDA–2013–N–1518] (premarket approval). Color additives, Cosmetics, Drugs, Under section 513(d) of the FD&C Act, Cardiovascular Devices; devices that were in commercial Medical devices. Reclassification of Nonroller-Type distribution before the enactment of the Therefore, under the Federal Food, Cardiopulmonary Bypass Blood 1976 amendments, May 28, 1976 Drug, and Cosmetic Act and under Pumps for Cardiopulmonary and (generally referred to as authority delegated to the Commissioner Circulatory Bypass; Effective Date of ‘‘preamendments devices’’), are of Food and Drugs, and redelegated to Requirement for Premarket Approval classified after FDA has: (1) Received a the Director, Center for Food Safety and for Nonroller-Type Cardiopulmonary recommendation from a device Applied Nutrition, 21 CFR part 73 is Bypass Blood Pumps for Temporary classification panel (an FDA advisory amended as follows: Ventricular Support committee) (the Panel); (2) published the Panel’s recommendation for PART 73—LISTING OF COLOR AGENCY: Food and Drug Administration, comment, along with a proposed ADDITIVES EXEMPT FROM HHS. regulation classifying the device; and (3) CERTIFICATION ACTION: Final order. published a final regulation classifying ■ 1. The authority citation for 21 CFR SUMMARY: The Food and Drug the device. FDA has classified most part 73 continues to read as follows: Administration (FDA) is issuing a final preamendments devices under these order to reclassify nonroller-type procedures. Authority: 21 U.S.C. 321, 341, 342, 343, Devices that were not in commercial 348, 351, 352, 355, 361, 362, 371, 379e. cardiopulmonary bypass blood pump (NRP) devices for cardiopulmonary and distribution prior to May 28, 1976 circulatory bypass, a preamendments (generally referred to as ■ 2. Section 73.350 is amended by ‘‘postamendments devices’’), are revising paragraph (c)(1)(ii) and by class III device, into class II (special automatically classified by section adding paragraph (c)(1)(iii) to read as controls), and to require the filing of a 513(f) of the FD&C Act into class III follows: premarket approval application (PMA) without any FDA rulemaking process. for NRP devices for temporary § 73.350 Mica-based pearlescent Those devices remain in class III and ventricular support. FDA is also revising require premarket approval unless, and wreier-aviles on DSK5TPTVN1PROD with RULES pigments. the title and identification of the * * * * * until, the device is reclassified into class regulation for NRP devices in this order. (c) * * * I or II or FDA issues an order finding the DATES: This order is effective June 8, device to be substantially equivalent, in (1) * * * (ii) In amounts up to 0.07 percent, by 2015. accordance with section 513(i) of the weight, in the following: FOR FURTHER INFORMATION CONTACT: FD&C Act, to a predicate device that (A) Distilled spirits containing not Fernando Aguel, Center for Devices and does not require premarket approval. less than 18 percent and not more than Radiological Health, Food and Drug The Agency determines whether new VerDate Sep<11>2014 15:05 Jun 05, 2015 Jkt 235001 PO 00000 Frm 00041 Fmt 4700 Sfmt 4700 E:\FR\FM\08JNR1.SGM 08JNR1


Document Created: 2018-02-22 10:12:34
Document Modified: 2018-02-22 10:12:34
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionRules and Regulations
ActionFinal rule.
DatesThis rule is effective July 9, 2015. See section VIII for further information on the filing of objections. Submit either electronic or written objections and requests for a hearing by July 8, 2015.
ContactEllen Anderson, Center for Food Safety and Applied Nutrition (HFS-265), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740-3835, 240-402-1309.
FR Citation80 FR 32303 
CFR AssociatedColor Additives; Cosmetics; Drugs and Medical Devices
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