[Federal Register Volume 70, Number 55 (Wednesday, March 23, 2005)]
[Rules and Regulations]
[Pages 14530-14532]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-5641]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 184

[Docket No. 1999P-5332]


Substances Affirmed as Generally Recognized as Safe: Menhaden Oil

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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SUMMARY: The Food and Drug Administration (FDA) is amending its 
regulations by reallocating the uses of menhaden oil in food that 
currently are established in the regulations, with the condition that 
when menhaden oil is added to food it is not used in combination with 
other added oils that are significant sources of eicosapentaenoic acid 
(EPA) and docosahexaenoic acid (DHA).

DATES: This rule is effective March 23, 2005. Submit written or 
electronic objections and requests for a hearing by April 22, 2005.

ADDRESSES: You may submit written objections and requests for a 
hearing, identified by Docket No. 1999P-5332, by any of the following 
methods:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting objections.
     Agency Web site: http://www.fda.gov/dockets/ecomments. 
Follow the instructions for submitting objections on the agency Web 
site.
     E-mail: [email protected]. Include Docket No. 1999P-
5332 in the subject line of your e-mail message.
     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.
    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.fda.gov/ohrms/dockets/default.htm, 
including any personal information provided. For detailed instructions 
on submitting objections, see the paragraph pertaining to objections 
and requests for a hearing in the SUPPLEMENTARY INFORMATION section of 
this document.
    Docket: For access to the docket to read background documents or 
objections received, go to http://www.fda.gov/ohrms/dockets/default.htm 
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: Andrew J. Zajac, Center for Food 
Safety and Applied Nutrition (HFS-265), Food and Drug Administration, 
5100 Paint Branch Pkwy., College Park, MD 20740-3835, 301-436-1267.

SUPPLEMENTARY INFORMATION: In response to a petition (GRASP 6G0316) 
from the National Fish Meal and Oil Association (NFMOA), FDA issued a 
final rule on June 5, 1997 (62 FR 30751) (the June 1997 final rule) 
affirming menhaden oil as generally recognized as safe (GRAS) for use 
as a direct human food ingredient with limitations on the maximum use 
levels of menhaden oil in specific food categories. FDA concluded that 
these limitations are necessary to ensure that daily intakes of EPA and 
DHA from menhaden oil do not exceed 3.0 grams per person per day (g/p/
d). As stated in the June 1997 final rule, the maximum limit of 3.0 g/
p/d on the total daily intake of EPA and DHA is a safeguard against the 
possible adverse effects of these fatty acids on increased bleeding 
time (the time taken for bleeding from a standardized skin wound to 
cease), glycemic control in non-insulin dependent diabetics, and 
increased levels of low-density lipoprotein cholesterol.
    On February 26, 2002 (the February 2002 proposed rule), FDA 
published a proposed rule in the Federal Register (67 FR 8744) in 
response to a petition from the NFMOA to amend Sec.  184.1472 (21 CFR 
184.1472) by reallocating the uses of menhaden oil in food that were 
previously affirmed as GRAS, while maintaining the total daily intake 
of EPA and DHA from menhaden oil at a level not exceeding 3.0 g/p/d. 
The reallocation is performed by the following three actions: (1) 
Reducing the maximum levels of use of menhaden oil in some of the 
currently listed food categories; (2) adding additional food categories 
along with assigning maximum levels of use in these new categories; and 
(3) eliminating the listing of subcategories, e.g., cookies and 
crackers, breads and rolls, fruit pies and custard pies, and cakes, and 
including them under broader food categories, e.g., baked goods and 
baking mixes.
    Because of developing interest in food ingredients that are 
significant sources of EPA and DHA, especially other fish oils, FDA 
believed that it was necessary to state explicitly in the regulation 
that when menhaden oil is added as an

[[Page 14531]]

ingredient in foods, it may not be used in combination with any other 
added oil that is a significant source of EPA and DHA. Without this 
restriction, the intake of DHA and EPA could exceed 3.0 g/p/d. 
Therefore, FDA published a tentative final rule in the Federal Register 
of January 15, 2004 (69 FR 2313) (the January 2004 tentative final 
rule), in which FDA tentatively concluded that the reallocated uses of 
menhaden oil are GRAS, but only when the menhaden oil is not used in 
combination with any other added oil that is a significant source of 
EPA and DHA. Because the February 2002 proposed rule did not include a 
condition of use for other added oils, FDA issued this final rule as 
tentative to give interested persons an opportunity (75 days) to 
comment on this use limitation.
    FDA received two comments on the tentative final rule. One comment 
expressed general support for the proposed action. The other comment 
expressed opposition to it because of labeling issues and environmental 
concerns. Labeling issues pertaining to menhaden oil are outside the 
scope of the proposed rule and will not be discussed further. With 
regard to environmental concerns, the comment asserts that the menhaden 
fish population is in short supply and that the regional fish 
commissions responsible for monitoring the menhaden population are 
biased organizations and controlled by the fishing industry. This 
assertion is not supported by factual information and addresses an 
issue outside FDA jurisdiction. Furthermore, the comment does not 
provide the agency with any information that affects the agency's 
previous determination that reallocating the foods to which menhaden 
oil can be added will not have a significant impact on the human 
environment and that an environmental impact statement is not required. 
In addition to labeling and environmental concerns, the comment also 
asserts that FDA's conclusion that there are no safety concerns from 
food uses of menhaden oil due to possible bioaccumulation of lipophilic 
chemical contaminants in the source fish is unsupported because FDA 
does not identify the data that it evaluated. FDA responded in the 
January 2004 tentative final rule to comments that were received 
pertaining to concerns about the potential for lipophilic chemical 
contaminants in menhaden oil. FDA's response to these concerns referred 
to data that were evaluated by FDA on levels of various chemical 
contaminants in menhaden oil. The data referred to by FDA in its 
response are part of the administrative record and are in the docket 
(Docket No. 1999P-5332). In addition, a copy of FDA's evaluation of 
these data was placed in the docket when the tentative final rule 
published. Therefore, FDA's conclusion regarding the potential for 
lipophilic chemical contaminants in menhaden oil is fully supported by 
data in the administrative record. FDA did not receive any comments on 
the limitation that when menhaden oil is added to food it is not to be 
used in combination with any other added oil that is a significant 
source of EPA and DHA. The agency is therefore issuing this final rule 
based on the tentative final rule and is amending Sec.  184.1472 as set 
forth below.
    Any person who will be adversely affected by this regulation may 
file with the Division of Dockets Management (see ADDRESSES) written or 
electronic objections by (see DATES). 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.

List of Subjects in 21 CFR Part 184

    Food additives.

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 Director, Center for Food Safety and Applied 
Nutrition, 21 CFR part 184 is amended as follows:

PART 184--DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED 
AS SAFE

0
1. The authority citation for 21 CFR part 184 continues to read as 
follows:

    Authority: 21 U.S.C. 321, 342, 348, 371.

0
2. Section 184.1472 is amended by revising paragraphs (a)(2)(iii) and 
(a)(3) and adding paragraph (a)(4) to read as follows:


Sec.  184.1472   Menhaden oil.

    (a) * * *
    (2) * * *
    (iii) Saponification value. Between 180 and 200 as determined by 
the American Oil Chemists' Society Official Method Cd 3-25--
``Saponification Value'' (reapproved 1989), which is incorporated by 
reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies 
of this publication are available from the Office of Food Additive 
Safety, Center for Food Safety and Applied Nutrition (HFS-200), Food 
and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 
20740, or available for inspection at the Center for Food Safety and 
Applied Nutrition's Library, Food and Drug Administration, 5100 Paint 
Branch Pkwy., College Park, MD 20740, or at the National Archives and 
Records Administration (NARA). For information on the availability of 
this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.
* * * * *
    (3) In accordance with Sec.  184.1(b)(2), the ingredient may be 
used in food only within the following specific limitations to ensure 
that total intake of eicosapentaenoic acid or docosahexaenoic acid does 
not exceed 3.0 grams/person/day:

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                   Category of food                             Maximum level of use in food (as served)
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Baked goods, baking mixes, Sec.   170.3(n)(1) of this                                                5.0 percent
 chapter.
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Cereals, Sec.   170.3(n)(4) of this chapter.                                                         4.0 percent
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[[Page 14532]]

 
Cheese products, Sec.   170.3(n)(5) of this chapter.                                                 5.0 percent
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Chewing gum, Sec.   170.3(n)(6) of this chapter.                                                     3.0 percent
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Condiments, Sec.   170.3(n)(8) of this chapter.                                                      5.0 percent
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Confections, frostings, Sec.   170.3(n)(9) of this                                                   5.0 percent
 chapter.
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Dairy product analogs, Sec.   170.3(n)(10) of this                                                   5.0 percent
 chapter.
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Egg products, Sec.   170.3(n)(11) of this chapter.                                                   5.0 percent
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Fats, oils, Sec.   170.3(n)(12) of this chapter, but                                                12.0 percent
 not in infant formula.
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Fish products, Sec.   170.3(n)(13) of this chapter.                                                  5.0 percent
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Frozen dairy desserts, Sec.   170.3(n)(20) of this                                                   5.0 percent
 chapter.
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Gelatins, puddings, Sec.   170.3(n)(22) of this                                                      1.0 percent
 chapter.
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Gravies, sauces, Sec.   170.3(n)(24) of this chapter.                                                5.0 percent
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Hard candy, Sec.   170.3(n)(25) of this chapter.                                                    10.0 percent
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Jams, jellies, Sec.   170.3(n)(28) of this chapter.                                                  7.0 percent
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Meat products, Sec.   170.3(n)(29) of this chapter.                                                  5.0 percent
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Milk products, Sec.   170.3(n)(31) of this chapter.                                                  5.0 percent
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Nonalcoholic beverages, Sec.   170.3(n)(3) of this                                                   0.5 percent
 chapter.
----------------------------------------------------------------------------------------------------------------
Nut products, Sec.   170.3(n)(32) of this chapter.                                                   5.0 percent
----------------------------------------------------------------------------------------------------------------
Pastas, Sec.   170.3(n)(23) of this chapter.                                                         2.0 percent
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Plant protein products, Sec.   170.3(n)(33) of this                                                  5.0 percent
 chapter.
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Poultry products, Sec.   170.3(n)(34) of this chapter.                                               3.0 percent
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Processed fruit juices, Sec.   170.3(n)(35) of this                                                  1.0 percent
 chapter.
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Processed vegetable juices, Sec.   170.3(n)(36) of                                                   1.0 percent
 this chapter.
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Snack foods, Sec.   170.3(n)(37) of this chapter.                                                    5.0 percent
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Soft candy, Sec.   170.3(n)(38) of this chapter.                                                     4.0 percent
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Soup mixes, Sec.   170.3(n)(40) of this chapter.                                                     3.0 percent
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Sugar substitutes, Sec.   170.3(n)(42) of this                                                      10.0 percent
 chapter.
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Sweet sauces, toppings, syrups, Sec.   170.3(n)(43) of                                               5.0 percent
 this chapter.
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    (4) To ensure safe use of the substance, menhaden oil shall not be 
used in combination with any other added oil that is a significant 
source of eicosapentaenoic acid or docosahexaenoic acid.
* * * * *

    Dated: March 14, 2005.
Leslye M. Fraser,
Director, Office of Regulations and Policy, Center for Food Safety and 
Applied Nutrition.
[FR Doc. 05-5641 Filed 3-22-05; 8:45 am]
BILLING CODE 4160-01-S