[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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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