Listing of Color Additives Exempt From Certification; Spirulina Extract, 30731-30734 [2017-13867]
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Federal Register / Vol. 82, No. 126 / Monday, July 3, 2017 / Rules and Regulations
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Submit electronic comments in the
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• Federal eRulemaking Portal:
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sradovich on DSK3GMQ082PROD with RULES
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 comments
submitted to the Dockets Management
Staff, FDA will post your comment, 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–
2011–F–0172 for ‘‘Food Labeling;
Nutrition Labeling of Standard Menu
Items in Restaurants and Similar Retail
Food Establishments.’’ Received
comments, 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 a comment with confidential
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made publicly available, submit your
comments only as a written/paper
submission. You should submit two
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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/201523389.pdf.
Docket: For access to the docket to
read background documents or the
electronic and written/paper comments
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:
Felicia B. Billingslea, Center for Food
Safety and Applied Nutrition (HFS–
820), Food and Drug Administration,
5001 Campus Dr., College Park, MD
20740, 240–402–2371.
SUPPLEMENTARY INFORMATION: In the
Federal Register of May 4, 2017, FDA
published an interim final rule with a
60-day comment period to request
comments on the extension of the
compliance date for our final rule
requiring disclosure of certain nutrition
information for standard menu items in
certain restaurants and retail food
establishments. The interim final rule
extended the compliance date from May
5, 2017, to May 7, 2018, and invited
comment on several specific questions
on how we might further reduce the
regulatory burden or increase flexibility
while continuing to achieve our
regulatory objectives to provide
consumers with nutrition information
so that they can make informed choices
for themselves and their families.
Comments will inform FDA’s regulation
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30731
for the disclosure of certain nutrition
information for standard menu items in
certain restaurants and retail food
establishments.
We have received a request for a 60day extension of the comment period for
the interim final rule. The request
conveyed concern that the current 60day comment period does not allow
sufficient time to develop a meaningful
or thoughtful response to the interim
final rule.
FDA has considered the request and
is extending the comment period for the
interim final rule for 30 days, until
August 2, 2017. We believe that a 30day extension allows adequate time for
interested persons to submit comments
without significantly delaying Agency
action on these important issues.
Dated: June 27, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning,
Legislation, and Analysis.
[FR Doc. 2017–13889 Filed 6–30–17; 8:45 am]
BILLING CODE 4164–01–P
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.
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
SUMMARY:
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Federal Register / Vol. 82, No. 126 / Monday, July 3, 2017 / Rules and Regulations
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.
sradovich on DSK3GMQ082PROD with RULES
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.
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17:08 Jun 30, 2017
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• 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/201523389.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
§ 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
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biomass of Arthrospira platensis, to
seasonally color the shells of hardboiled 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 § 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-toeat 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 bluecolored 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 § 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
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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
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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
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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 GRASnotified 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 hardboiled 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 peerreviewed 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
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30733
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 hardboiled 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 § 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
§ 71.15, we will delete from the
documents any materials that are not
available for public disclosure.
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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.
sradovich on DSK3GMQ082PROD with RULES
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
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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.
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.
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.
§ 73.530
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, (https://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
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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
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.
2. Section 73.530 is amended by
revising paragraph (c) to read as follows:
■
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-toeat 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 hardboiled 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
E:\FR\FM\03JYR1.SGM
03JYR1
Agencies
[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]
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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.
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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, (https://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