
[Federal Register Volume 82, Number 126 (Monday, July 3, 2017)]
[Rules and Regulations]
[Pages 30731-30734]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-13867]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 73

[Docket No. FDA-2016-C-2570]


Listing of Color Additives Exempt From Certification; Spirulina 
Extract

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 expanded safe use of 
spirulina extract to seasonally color hard-boiled shell eggs at levels 
consistent with good manufacturing practice (GMP). This action is in 
response to a color additive petition (CAP) filed by McCormick & 
Company, Inc. (McCormick).

DATES: This rule is effective August 3, 2017. Submit either electronic 
or written objections and requests for a hearing on the final rule by 
August 2, 2017. See section IX for further information on the filing of 
objections.

ADDRESSES: You may submit either electronic or written objections and 
requests for a hearing as follows. Please note that late, untimely 
filed objections will not be considered. Electronic objections must be 
submitted on or before August 2, 2017. The https://www.regulations.gov 
electronic filing

[[Page 30732]]

system will accept comments until midnight Eastern Time at the end of 
August 2, 2017. Objections received by mail/hand delivery/courier (for 
written/paper submissions) will be considered timely if they are 
postmarked or the delivery service acceptance receipt is on or before 
that date.

Electronic Submissions

    Submit electronic objections in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Objections submitted 
electronically, including attachments, to https://www.regulations.gov 
will be posted to the docket unchanged. Because your objection will be 
made public, you are solely responsible for ensuring that your 
objection does not include any confidential information that you or a 
third party may not wish to be posted, such as medical information, 
your or anyone else's Social Security number, or confidential business 
information, such as a manufacturing process. Please note that if you 
include your name, contact information, or other information that 
identifies you in the body of your objection, that information will be 
posted on https://www.regulations.gov.
     If you want to submit an objection with confidential 
information that you do not wish to be made available to the public, 
submit the objection as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper 
submissions): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper objections submitted to the Dockets 
Management Staff, FDA will post your objection, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2016-C-2570 for ``Listing of Color Additives Exempt From 
Certification; Spirulina Extract.'' Received objections, those filed in 
a timely manner (see ADDRESSES), will be placed in the docket and, 
except for those submitted as ``Confidential Submissions,'' publicly 
viewable at https://www.regulations.gov or at the Dockets Management 
Staff between 9 a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit an objection with 
confidential information that you do not wish to be made publicly 
available, submit your objections only as a written/paper submission. 
You should submit two copies total. One copy will include the 
information you claim to be confidential with a heading or cover note 
that states ``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' We 
will review this copy, including the claimed confidential information, 
in our consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on https://www.regulations.gov. 
Submit both copies to the Dockets Management Staff. If you do not wish 
your name and contact information to be made publicly available, you 
can provide this information on the cover sheet and not in the body of 
your comments and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed except in accordance with 21 CFR 10.20 and other 
applicable disclosure law. For more information about FDA's posting of 
comments to public dockets, see 80 FR 56469, September 18, 2015, or 
access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
objections received, go to https://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 Dockets 
Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Molly A. Harry, Center for Food Safety 
and Applied Nutrition, Food and Drug Administration, 5001 Campus Dr., 
College Park, MD 20740-3835, 240-402-1075.

SUPPLEMENTARY INFORMATION:

I. Introduction

    In a notice published in the Federal Register of September 16, 2016 
(81 FR 63728), we announced that we filed a color additive petition 
(CAP 6C0306) submitted by McCormick & Company, Inc., c/o Exponent, 1150 
Connecticut Ave. NW., suite 1100, Washington, DC 20036. The petition 
proposed to amend the color additive regulations in Sec.  73.530 (21 
CFR 73.530) Spirulina extract to provide for the expanded safe use of 
spirulina extract, prepared by the filtered aqueous extraction of the 
dried biomass of Arthrospira platensis, to seasonally color the shells 
of hard-boiled eggs. The color additive is intended to be sold as a 
powder in a packet to consumers at levels consistent with GMP.

II. Background

    Spirulina extract is currently approved under Sec.  73.530 for 
coloring confections (including candy and chewing gum), frostings, ice 
cream and frozen desserts, dessert coatings and toppings, beverage 
mixes and powders, yogurts, custards, puddings, cottage cheese, 
gelatin, breadcrumbs, ready-to-eat cereals (excluding extruded 
cereals), and coating formulations applied to dietary supplement 
tablets and capsules, at levels consistent with GMP. Spirulina extract 
also is currently approved under 21 CFR 73.1530 for coloring coating 
formulations applied to drug tablets and capsules, at levels consistent 
with GMP. Spirulina extract is exempt from certification under section 
721(c) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 
U.S.C. 379e(c)) because we previously determined that certification was 
not necessary for the protection of public health (78 FR 49117 at 
49119, August 13, 2013).
    The spirulina extract that is the subject of this final rule is a 
blue-colored powder produced by the filtered aqueous extraction of the 
dried biomass of A. platensis (also known as Spirulina platensis), an 
edible blue-green cyanobacterium. The color additive contains 
phycocyanins as the principal coloring components. Based on data and 
information provided in the petition on the identity, physical and 
chemical properties, manufacturing process, and composition of the 
color additive, we have determined that the color additive meets the 
specifications for spirulina extract in Sec.  73.530 (Ref. 1).
    Spirulina-derived ingredients have also been the subject of four 
notices submitted by firms to FDA informing us of their determinations 
that certain uses of these substances in food are generally recognized 
as safe (GRAS) (78 FR 49117 at 49118). Under section 201(s) of the FD&C 
Act (21 U.S.C. 321(s)), a substance that is GRAS for a particular use 
in food is not a food additive, and may lawfully be utilized for that 
use without our review and approval. There is no GRAS exemption, 
however, to the definition of color additive in section 201(t) of the 
FD&C Act). Therefore, we must approve the use of a color additive in 
food before it is marketed; otherwise the food containing the color 
additive is adulterated under section 402(c) of the FD&C Act (21 U.S.C. 
342(c)). One GRAS

[[Page 30733]]

notice (GRN 000424) pertains to the use of a spirulina-derived 
substance that is similar in chemical composition to the color additive 
that is the subject of this final rule, but the substance that was the 
subject of GRN 000424 has a much higher phycocyanin content (Ref. 3). 
Importantly, in our response to these GRAS notifications, we indicated 
that if the substances that were the subject of these submissions 
impart color to the food, they may be subject to regulation as a color 
additive.

III. Safety Evaluation

A. Determination of Safety

    Under section 721(b)(4) of the FD&C Act, a color additive may not 
be listed for a particular use unless the data and information 
available to FDA establish that the color additive is safe for that 
use. Our color additive regulations at 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 foods is not harmful under its intended 
conditions of use, we consider the projected human dietary exposure to 
the color additive, the additive's toxicological data, and other 
relevant information (such as published literature) available to us. We 
compare an individual's estimated exposure, or estimated daily intake 
(EDI), of the color additive from all food sources to an acceptable 
daily intake level established by toxicological data. The EDI is 
determined by projections based on the amount of the color additive 
proposed for use in particular foods or drugs and on data regarding the 
amount consumed from all ingested sources of the color additive. We 
commonly use the EDI for the 90th percentile consumer of a color 
additive as a measure of high chronic exposure.

B. Safety of Petitioned Use of the Color Additive

    During our safety review of this petition (CAP 6C0306), we 
considered the projected human dietary exposure to spirulina extract 
and to phycocyanins (the principal coloring components) from the 
petitioned use and from currently permitted uses of spirulina extract 
in foods and ingested drugs. McCormick submitted an exposure estimate 
for spirulina extract and for phycocyanins for the petitioned use of 
spirulina extract based on a worst-case scenario that presumed that 
spirulina extract could potentially migrate from the outside of the egg 
shell to the edible portion of the egg. McCormick estimated that the 
petitioned use of spirulina extract to seasonally color the shells of 
hard-boiled eggs would result in an exposure to spirulina extract of 
8.8 milligrams per person per day (mg/p/d) at the 90th percentile for 
the U.S. population aged 2 years and older (Ref. 2). McCormick also 
estimated that the petitioned use of spirulina extract would result in 
an exposure to phycocyanins of 1.9 mg/p/d at the 90th percentile for 
the U.S. population aged 2 years and older (Ref. 2). Despite providing 
this worst-case estimate, McCormick noted that egg shells are not 
consumed and demonstrated that the spirulina extract applied to the 
outside of an egg shell generally does not migrate through the shell 
and the outer and inner membranes separating the shell from the edible 
portion of the egg. For these reasons, McCormick asserted that the 
amount of spirulina extract that would actually be found on the edible 
portion of an egg would be negligible, resulting in a 0.17 percent 
increase of the cumulative estimated daily intake (CEDI) for 
phycocyanins (Ref. 2). The previously estimated upper bound CEDI for 
phycocyanins from all GRAS-notified uses of spirulina extract in food 
is 1,140 mg/p/day or 19 milligrams per kilogram body weight per day 
(mg/kg bw/d) for a 60 kg individual based on uses addressed in GRN 
000424 (Ref. 3). We agree that McCormick's exposure estimate is 
sufficiently conservative. We conclude that the exposure to spirulina 
extract and phycocyanins resulting from the petitioned use of spirulina 
extract to seasonally color the shells of hard-boiled eggs is 
negligible, and that the petitioned use would not result in a 
significant contribution to the CEDI for phycocyanins (Ref. 2).
    To support the safety of the proposed use of spirulina extract to 
color the shells of hard-boiled eggs, McCormick referenced the safety 
determinations made by FDA for CAPs 2C0293 (78 FR 49117, August 13, 
2013), 2C0297 (79 FR 20095, April 11, 2014), and 4C0300 (80 FR 50762, 
August 21, 2015). McCormick also conducted a search of the peer-
reviewed scientific literature for animal and human oral consumption 
studies that tested spirulina, spirulina-derived ingredients, and 
phycocyanins that were published between January 1, 2014, and July 20, 
2016. McCormick submitted to us the published animal and human studies 
that they identified as being relevant to their petition. We evaluated 
the submitted safety information and additional studies that we 
identified as relevant and concluded that this information does not 
raise any safety concerns (Refs. 4 and 5).
    In our previous evaluation of the use of spirulina extract as a 
color additive in foods (80 FR 50762), we did not have any concerns 
regarding the safety of the use of spirulina extract and its major 
coloring components, phycocyanins. Taking into account all the 
available safety information and the estimated exposure to phycocyanins 
from the petitioned use, we conclude that the proposed use of spirulina 
extract to seasonally color the shells of hard-boiled eggs is safe 
(Ref. 5).
    We discussed the potential allergenicity of spirulina phycocyanins 
in our final rule for the use of spirulina extract as a color additive 
in candy and chewing gum (78 FR 49117 at 49119). Based on the 
comparison of the known amino acid sequences of phycocyanins with the 
sequences of known protein allergens, we determined that there is a low 
probability that phycocyanins are protein allergens. We therefore 
concluded that the spirulina phycocyanins present an insignificant 
allergy risk. Additionally, after a review of the literature relevant 
to the potential allergenicity of spirulina phycocyanins, we have 
determined that spirulina phycocyanins still present an insignificant 
allergy risk (Refs. 4-7). We are not aware of any new information that 
would cause us to change this conclusion.

IV. Conclusion

    Based on the data and information in the petition and other 
relevant material, we conclude that the petitioned use of spirulina 
extract to seasonally color the shells of hard-boiled eggs is safe. We 
further conclude that the color additive will achieve its intended 
technical effect and is suitable for the petitioned use. Consequently, 
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 continue to conclude that certification 
of spirulina extract is not necessary for the protection of the public 
health.

V. Public Disclosure

    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.

[[Page 30734]]

VI. Analysis of Environmental Impact

    We previously considered the environmental effects of this rule, as 
stated in the September 16, 2016, Federal Register notice of petition 
for CAP 6C0306 (81 FR 63728). We stated that we had determined, under 
21 CFR 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 
determination.

VII. 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.

VIII. Section 301(ll) of the FD&C 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 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.

IX. 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 Dockets Management Staff (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.
    Any objections received in response to the regulation may be seen 
in the Dockets Management Staff between 9 a.m. and 4 p.m., Monday 
through Friday, and will be posted to the docket at https://www.regulations.gov. We will publish notice of the objections that we 
have received or lack thereof in the Federal Register.

X. References

    The following references are on display in the Dockets Management 
Staff (see ADDRESSES) and are available for viewing by interested 
persons between 9 a.m. and 4 p.m., Monday through Friday; they are also 
available electronically at https://www.regulations.gov. FDA has 
verified the Web site addresses, as of the date this document publishes 
in the Federal Register, but Web sites are subject to change over time.

1. Memorandum from N. Belai, Color Technology Team, Office of 
Cosmetics and Colors (OCAC), Center for Food Safety and Applied 
Nutrition (CFSAN), FDA to M. Harry, Division of Petition Review, 
Office of Food Additive Safety (OFAS), CFSAN, FDA, February 1, 2017.
2. Memorandum from H. Lee, Division of Petition Review, OFAS, CFSAN, 
FDA to M. Harry, Division of Petition Review, OFAS, CFSAN, FDA, 
February 1, 2017.
3. Letter from D. Keefe, OFAS, CFSAN, FDA to H. Newman, Desert Lake 
Technologies, LLC, Agency Response Letter GRAS Notice 000424, 
December 6, 2012, (http://www.fda.gov/Food/IngredientsPackagingLabeling/GRAS/NoticeInventory/ucm335743.htm).
4. Memorandum from L. Rosenfeld, Division of Petition Review, OFAS, 
CFSAN, FDA to J. Park, Division of Petition Review, OFAS, CFSAN, 
FDA, January 12, 2017.
5. Memorandum from J. Park, Division of Petition Review, OFAS, 
CFSAN, FDA to M. Harry, Division of Petition Review, OFAS, CFSAN, 
FDA, February 2, 2017.
6. Memorandum from J. Park, Division of Petition Review, OFAS, 
CFSAN, FDA to M. Harry, Division of Petition Review, OFAS, CFSAN, 
FDA, April 13, 2017.
7. Memorandum from J. Park, Division of Petition Review, OFAS, 
CFSAN, FDA to M. Harry, Division of Petition Review, OFAS, CFSAN, 
FDA, April 25, 2017.

List of Subjects in 21 CFR Part 73

    Color additives, Cosmetics, Drugs, Foods, Medical devices.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Food and Drugs, 21 CFR part 
73 is amended as follows:

PART 73--LISTING OF COLOR ADDITIVES EXEMPT FROM CERTIFICATION

0
1. The authority citation for 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 73.530 is amended by revising paragraph (c) to read as 
follows:


Sec.  73.530  Spirulina extract.

* * * * *
    (c) Uses and restrictions. Spirulina extract may be safely used for 
coloring confections (including candy and chewing gum), frostings, ice 
cream and frozen desserts, dessert coatings and toppings, beverage 
mixes and powders, yogurts, custards, puddings, cottage cheese, 
gelatin, breadcrumbs, ready-to-eat cereals (excluding extruded 
cereals), coating formulations applied to dietary supplement tablets 
and capsules, at levels consistent with good manufacturing practice, 
and to seasonally color the shells of hard-boiled eggs, except that it 
may not be used to color foods for which standards of identity have 
been issued under section 401 of the Federal Food, Drug, and Cosmetic 
Act, unless the use of the added color is authorized by such standards.
* * * * *

    Dated: June 21, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-13867 Filed 6-30-17; 8:45 am]
 BILLING CODE 4164-01-P


