[Federal Register Volume 74, Number 219 (Monday, November 16, 2009)]
[Rules and Regulations]
[Pages 58843-58846]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-27394]
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Rules and Regulations
Federal Register
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This section of the FEDERAL REGISTER contains regulatory documents
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Federal Register / Vol. 74, No. 219 / Monday, November 16, 2009 /
Rules and Regulations
[[Page 58843]]
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 73
[Docket No. FDA-2007-C-0456] (formerly Docket No. 2007-C-0245)
Listing of Color Additives Exempt From Certification; Paracoccus
Pigment
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule.
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SUMMARY: The Food and Drug Administration (FDA) is amending the color
additive regulations to provide for the safe use of paracoccus pigment
as a color additive in the feed of salmonid fish to enhance the color
of their flesh. This action is in response to a petition filed by
Nippon Oil Corp.
DATES: This rule is effective December 17, 2009, except as to any
provisions that may be stayed by the filing of proper objections.
Submit electronic or written objections and requests for a hearing by
December 16, 2009. See section X of this document for information on
the filing of objections.
ADDRESSES: You may submit electronic or written objections and
requests for a hearing identified by Docket No. FDA-2007-C-0456, 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:
FAX: 301-827-6870.
Mail/Hand delivery/Courier [For paper, disk, or CD-ROM
submissions]: Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
To ensure more timely processing of objections, FDA is no longer
accepting objections submitted to the agency by e-mail. FDA encourages
you to continue to submit electronic objections by using the Federal
eRulemaking Portal, as described previously, in the ADDRESSES portion
of this document under Electronic Submissions.
Instructions: All submissions received must include the agency name
and docket number for this rulemaking. All objections received will be
posted without change to http://www.regulations.gov, including any
personal information provided. For detailed instructions on submitting
objections, see the ``Objections'' heading of the SUPPLEMENTARY
INFORMATION section of this document.
Docket: For access to the docket to read background documents or
objections received, go to http://www.regulations.gov and insert the
docket number, 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: Mical E. Honigfort, Center for Food
Safety and Applied Nutrition (HFS-265), Food and Drug Administration,
5100 Paint Branch Pkwy., College Park, MD 20740-3835, 301-436-1278.
SUPPLEMENTARY INFORMATION:
I. Background
In a notice published in the Federal Register of July 9, 2007 (72
FR 37243), FDA announced that a color additive petition (CAP 7C0283)
had been filed by Nippon Oil Corp., c/o Beckloff Associates, 7400 West
110th St. suite 300, Overland Park, KS 66210. The petition proposed to
amend the color additive regulations in part 73 (21 CFR part 73) to
provide for the safe use of Paracoccus carotinifaciens (P.
carotinifaciens) granules as a color additive in the feed of salmonid
fish to enhance the color of their flesh. This color additive is
commonly known as paracoccus pigment. Therefore, the agency is
establishing paracoccus pigment as the common or usual name for this
color additive.
II. Identity, Technical Effect, and Specifications
Paracoccus pigment consists of cells of the bacterium P.
carotinifaciens that are produced by fermentation, and then killed by
heat. The major components of the dried cells are proteins,
carbohydrates, and lipids. The cells may be mixed with calcium
carbonate added as necessary to yield a granular solid that contains at
least 1.75 percent (weight/weight) astaxanthin and lesser amounts of
other carotenoids as coloring agents. Calcium carbonate is added to
adjust the astaxanthin content to the appropriate level in the final
pigment. The primary coloring substance in paracoccus pigment is
astaxanthin, which is typically present in the color additive at an
average concentration of 2.18 percent, and represents approximately 51
percent of the total carotenoids present. The approximate levels of
other carotenoids present in paracoccus pigment at lower levels that
contribute to the color of the salmonid flesh are adonirubin (30
percent), canthaxanthin (10 percent), adonixanthin (4 percent), and
asteroidenone (2 percent). When fed to salmonid fish, the petitioned
use of paracoccus pigment results in deposition of very small amounts
of carotenoids in the flesh of the fish. Studies included in the
petition showed that paracoccus pigment at the intended level of use
satisfactorily pigmented the flesh of the fish to levels comparable to
that in wild salmonids.
In the Federal Register of April 13, 1995 (60 FR 18736), the agency
published a final rule that listed astaxanthin in Sec. 73.35 (21 CFR
73.35) for use in the feed of salmonid fish. In that final rule, the
agency concluded that 80 milligrams (mg) of astaxanthin per (/)
kilogram (kg) of finished feed would result in adequate pigmentation of
the flesh of salmonid fish. Therefore, in Sec. 73.35(c)(2), the agency
limited the astaxanthin content of finished feed to not more than 80
mg/kg. In the Federal Register of July 6, 2000, the agency published
final rules that listed haematococcus algae meal in Sec. 73.185 (65 FR
41581) and phaffia yeast in Sec. 73.355 (65 FR 41584) as additional
sources of astaxanthin for use in the feed of salmonid fish. Both
[[Page 58844]]
haematococcus algae meal and phaffia yeast may be used alone or in
combination with other astaxanthin color additive sources, provided
that the quantity of astaxanthin in the finished feed does not exceed
80 mg/kg. Canthaxanthin also is listed for use as a color additive in
salmonid fish feed with a limit of 80 mg/kg of finished feed (Sec.
73.75).
Consistent with these other listings, the petitioner proposes that
the maximum amount of astaxanthin in finished feed from the use of
paracoccus pigment not exceed 80 mg/kg and has requested that this
level be specified in the listing regulation. Because of the other
listed sources of astaxanthin and other color additives that are
sources of astaxanthin the agency may list in the future, new Sec.
73.352(c)(2) requires that the quantity of astaxanthin in finished
feed, from paracoccus pigment when used alone or in combination with
other astaxanthin color additive sources listed in part 73, shall not
exceed 80 mg/kg (72 grams per ton) of finished feed.
III. Evaluation of Safety
In evaluating the safety of the use of paracoccus pigment in fish
feed, FDA considered the safety of the paracoccus pigment to humans and
fish and the safety of the producing organism, P. carotinifaciens.
A. Safety of Paracoccus Pigment
Because consumers are not directly exposed to the paracoccus
pigment, FDA focused its review on the safety of the carotenoids
present in the pigment that are deposited in the fish. The agency
considered the safety of astaxanthin and canthaxanthin, which are
already approved for use in the feed of salmonid fish, as well as the
safety of the other carotenoids in the pigment. Astaxanthin and
canthaxanthin are two substances found in wild salmonids that are
responsible for imparting the pink or red coloring to the flesh of
these fish. The agency has determined that the astaxanthin and
canthaxanthin from paracoccus pigment, which account for approximately
60 percent of the total carotenoids in paracoccus pigment, will
substitute for the fish feed uses of other approved color additive
sources of these carotenoids. Additionally, the agency considers the
intake of astaxanthin and canthaxanthin from the consumption of wild
salmon and the intake of astaxanthin and canthaxanthin from consumption
of farm-raised salmonid fish that have been fed approved color additive
sources of these carotenoids to be comparable. Therefore, the agency
concludes that the petitioned use of paracoccus pigment will not
increase the estimated daily intake of astaxanthin and canthaxanthin,
and that these two carotenoids are safe as components of the paracoccus
pigment in the feed of salmonid fish.
To support the safety of the petitioned use of the subject color
additive, including the carotenoids adonirubin, adonixanthin, and
asteroidenone, the petitioner provided data from studies in which sea
bream and rainbow trout were fed feed containing paracoccus pigment at
levels up to 5 percent in the feed. The studies did not reveal any
toxicity to the target fish species. Therefore, FDA concludes that the
petitioned use of paracoccus pigment is safe to salmonid fish. The
petitioner also provided results from toxicity studies in which rats
were fed paracoccus pigment. These studies did not reveal any adverse
effects from exposure to paracoccus pigment. Importantly, consumers
will not be directly exposed to paracoccus pigment, but to carotenoids
remaining in the fish that have consumed the color additive in their
diet. Therefore, based on the exposure estimates for the individual
carotenoids, the results from the fish and rat toxicity studies and
genetic toxicity tests, as well as previous safety determinations
regarding the use of astaxanthin and canthaxanthin in salmonid fish
feed, FDA concludes that there is a reasonable certainty of no harm to
consumers from the petitioned use of paracoccus pigment.
B. Safety of the Producing Organism, P. carotinifaciens
FDA reviewed the pathogenicity, toxigenic potential, and
antimicrobial activity of the producing organism, P. carotinifaciens.
The heat treatment during production of paracoccus pigment ensures that
no viable P. carotinifaciens cells will be in the final product and
ensures that there is no pathogenic or toxigenic potential of P.
carotinifaciens in the production of paracoccus pigment. In addition,
as a condition of safe use, FDA is requiring that only a nonpathogenic
and nontoxicogenic strain of the bacterium P. carotinifaciens be used
in the production of paracoccus pigment. FDA also reviewed a study that
provided evidence that the strain of P. carotinifaciens used to produce
paracoccus pigment is not capable of producing antibiotics. Based on
this information and the fact that consumers will not be directly
exposed to paracoccus pigment, but to carotenoids remaining in the fish
that have consumed the pigment, FDA concludes that the petitioned use
of P. carotinifaciens in the production of paracoccus pigment is safe.
IV. Labeling Requirements
All color additives, in accordance with Sec. 70.25 (21 CFR 70.25),
are required to be labeled with sufficient information to assure their
safe use and to allow a determination of compliance with any
limitations imposed by the agency in other applicable regulations. The
labeling of the color additive, paracoccus pigment, and any mixture
prepared therefrom, is subject to the requirements of Sec. 70.25.
According to Sec. 70.25(a)(4), an expiration date for a color
additive must be stated on its label if stability data require it. FDA
finds that because of the instability of astaxanthin in paracoccus
pigment, an expiration date must be stated on the label of sealed and
open containers, in accordance with Sec. 70.25(a)(4). FDA also finds
that declaration of the expiration date constitutes a material fact
that must be disclosed on the label of the color additive mixture under
sections 201(n) and 403(a)(1) of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 321(n) and 343(a)(1)). Failure to disclose the material
fact on the label of the color additive mixture would constitute a
failure to reveal facts that are: (1) Material in light of the
representations made on the label and (2) material with respect to
consequences which may result from the use of the color additive. The
use of paracoccus pigment requires the declaration of expiration dates
because astaxanthin in paracoccus pigment is unstable and can
decompose, thereby affecting the efficacy of the color.
In addition to the requirements for labeling the color additive or
color additive mixture, the ingredient list on fish feed, to which
paracoccus pigment is added, must identify the presence of the color
additive under Sec. 501.4 (21 CFR 501.4). New Sec. 73.352(d)(2)
references Sec. 501.4 to ensure that the presence of paracoccus
pigment as a color additive in the fish feed will be declared on the
ingredient label. Finally, the presence of the color additive must be
declared on the label of any food, including salmonid fish, containing
added paracoccus pigment and food containing such salmonid fish as an
ingredient. Section 101.22(b) (21 CFR 101.22(b)) requires a food that
bears or contains artificial coloring, such as salmon artificially
colored with paracoccus pigment, to bear labeling even though such food
is not in package form. Section 101.22(c) (21 CFR 101.22(c)) requires
that label statements of artificial coloring be ``likely to be read
[[Page 58845]]
by the ordinary person under customary conditions of purchase and use
of such food.''
Furthermore, Sec. 101.22(k)(2) requires, in the statement of
ingredients for a food to which any coloring has been added, and for
which the coloring is not subject to certification, a declaration that
makes it clear that a color additive has been used in the food. In
addition, the presence of a color additive in a food received in a bulk
container that is held at a retail establishment must be declared on
the labeling of the bulk container or on a counter card or other
similar device under the provisions in Sec. 101.100(a)(2) (21 CFR
101.100(a)(2)). The ingredient label would alert the consumer that the
fish is artificially colored. Without such ingredient labeling, food
comprising salmonid fish with added paracoccus pigment would be deemed
to be misbranded under section 403(k) of the Federal Food, Drug, and
Cosmetic Act, which states that: A food shall be deemed to be
misbranded ``If it bears or contains any artificial flavoring,
artificial coloring, or chemical preservative, unless it bears labeling
stating that fact * * *.''
Therefore, in accordance with Sec. Sec. 101.22(b), (c), and
(k)(2), and 101.100(a)(2), labeling on any salmonid fish containing
paracoccus pigment is required to declare the presence of the color
additive or color additive mixture. New Sec. 73.352(d)(3) references
Sec. Sec. 101.22(b), (c), and (k)(2), and 101.100(a)(2) to ensure
that, at the retail level, the presence of paracoccus pigment as a
color additive in the fish will be declared, and that the labeling of
the bulk fish container, including a list of ingredients, will be
displayed on the container or on a counter card with similar
information.
V. Conclusion
FDA reviewed data in the petition and other available relevant
material to evaluate the safety of the use of paracoccus pigment as a
color additive in the feed of salmonid fish to enhance the color of
their flesh. Based on this information, the agency concludes that the
proposed use of the additive is safe, and the additive will achieve its
intended technical effect. Therefore, the regulations in part 73 should
be amended as set forth in this document. In addition, based upon the
factors listed in Sec. 71.20(b) (21 CFR 71.20(b)), the agency
concludes that certification of paracoccus pigment is not necessary for
the protection of the public health.
VI. Public Disclosure
In accordance with Sec. 71.15 (21 CFR 71.15), the petition and the
documents that FDA considered and relied upon in reaching its decision
to approve the petition will be made available for inspection at the
Center for Food Safety and Applied Nutrition by appointment with the
information contact person (see FOR FURTHER INFORMATION CONTACT). As
provided in Sec. 71.15, the agency will delete from the documents any
materials that are not available for public disclosure before making
the documents available for inspection.
VII. Environmental Impact
The agency has previously considered the environmental effects of
this rule as announced in the notice of filing for CAP 7C0283 (72 FR
37243). No new information or comments have been received that would
affect the agency's previous determination that there is no significant
impact on the human environment and that an environmental impact
statement is not required.
VIII. 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.
IX. Section 301(ll) of the Federal Food, Drug, and Cosmetic Act
FDA's review of this petition was limited to section 721 of the act
(21 U.S.C. 379e). This final rule is not a statement regarding
compliance with other sections of the act. For example, the Food and
Drug Administration Amendments Act of 2007, which was signed into law
on September 27, 2007, amended the act to, among other things, add
section 301(ll). Section 301(ll) of the 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 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) through (4) applies. In our review
of this petition, FDA did not consider whether section 301(ll) 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).
Furthermore, this language is now included in all color additive final
rules for food use and therefore should not be construed to be a
statement of the likelihood that section 301(ll) applies.
X. Objections
This rule is effective as shown in the DATES section of this
document; except as to any provisions that may be stayed by the filing
of proper objections. Any person who will be adversely affected by this
regulation may file with the Division of Dockets Management (see
ADDRESSES) electronic or written objections. Each objection shall be
separately numbered, and each numbered objection shall specify with
particularity the provisions of the regulation to which objection is
made and the grounds for the objection. Each numbered objection on
which a hearing is requested shall specifically so state. Failure to
request a hearing for any particular objection shall constitute a
waiver of the right to a hearing on that objection. Each numbered
objection for which a hearing is requested shall include a detailed
description and analysis of the specific factual information intended
to be presented in support of the objection in the event that a hearing
is held. Failure to include such a description and analysis for any
particular objection shall constitute a waiver of the right to a
hearing on the objection. Three copies of all documents are to be
submitted and are to be identified with the docket number found in
brackets in the heading of this document. Any objections received in
response to the regulation may be seen in the Division of Dockets
Management between 9 a.m. and 4 p.m., Monday through Friday. FDA will
publish notice of the objections that the agency has received or lack
thereof in the Federal Register.
List of Subjects in 21 CFR Part 73
Color additives, Cosmetics, Drugs, Medical devices.
0
Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, and
redelegated to the 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 73.352 is added to subpart A to read as follows:
[[Page 58846]]
Sec. 73.352 Paracoccus pigment.
(a) Identity. (1) The color additive paracoccus pigment consists of
the heat-killed, dried cells of a nonpathogenic and nontoxicogenic
strain of the bacterium Paracoccus carotinifaciens and may contain
added calcium carbonate to adjust the astaxanthin level.
(2) Color additive mixtures for fish feed use made with paracoccus
pigment may contain only those diluents that are suitable and are
listed in this subpart as safe for use in color additive mixtures for
coloring foods.
(b) Specifications. Paracoccus pigment shall conform to the
following specifications and shall be free from impurities, other than
those named, to the extent that such impurities may be avoided by good
manufacturing practice:
(1) Physical state, solid.
(2) Lead, not more than 5 milligrams per kilogram (mg/kg) (5 parts
per million (ppm)).
(3) Arsenic, not more than 2 mg/kg (2 ppm).
(4) Mercury, not more than 1 mg/kg (1 ppm).
(5) Heavy metals (as Pb), not more than 10 mg/kg (10 ppm).
(6) Astaxanthin, not less than 1.75 percent.
(c) Uses and restrictions. Paracoccus pigment may be safely used in
the feed of salmonid fish in accordance with the following prescribed
conditions:
(1) The color additive is used to enhance the pink to orange-red
color of the flesh of salmonid fish.
(2) The quantity of astaxanthin in finished feed, from paracoccus
pigment when used alone or in combination with other astaxanthin color
additive sources listed in this part 73, shall not exceed 80 mg/kg (72
grams per ton) of finished feed.
(d) Labeling requirements. (1) The labeling of the color additive
and any premixes prepared therefrom shall bear expiration dates for the
sealed and open container (established through generally accepted
stability testing methods), other information required by Sec. 70.25
of this chapter, and adequate directions to prepare a final product
complying with the limitations prescribed in paragraph (c) of this
section.
(2) The presence of the color additive in finished fish feed
prepared according to paragraph (c) of this section shall be declared
in accordance with Sec. 501.4 of this chapter.
(3) The presence of the color additive in salmonid fish that have
been fed feeds containing paracoccus pigment shall be declared in
accordance with Sec. Sec. 101.22(b), (c), and (k)(2), and
101.100(a)(2) of this chapter.
(e) Exemption from certification. Certification of this color
additive is not necessary for the protection of the public health, and
therefore, batches thereof are exempt from the certification
requirements of section 721(c) of the act.
Dated: November 5, 2009.
Leslye M. Fraser,
Director, Office of Regulations, Policy and Social Sciences, Center for
Food Safety and Applied Nutrition.
[FR Doc. E9-27394 Filed 11-13-09; 8:45 am]
BILLING CODE 4160-01-S