[Federal Register: March 23, 2005 (Volume 70, Number 55)]
[Rules and Regulations]
[Page 14530-14532]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr23mr05-3]
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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: fdadockets@oc.fda.gov. 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
----------------------------------------------------------------------------------------------------------------
Chewing gum, Sec. 170.3(n)(6) of this chapter. 3.0 percent
----------------------------------------------------------------------------------------------------------------
Condiments, Sec. 170.3(n)(8) of this chapter. 5.0 percent
----------------------------------------------------------------------------------------------------------------
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.
----------------------------------------------------------------------------------------------------------------
Fish products, Sec. 170.3(n)(13) of this chapter. 5.0 percent
----------------------------------------------------------------------------------------------------------------
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
----------------------------------------------------------------------------------------------------------------
Hard candy, Sec. 170.3(n)(25) of this chapter. 10.0 percent
----------------------------------------------------------------------------------------------------------------
Jams, jellies, Sec. 170.3(n)(28) of this chapter. 7.0 percent
----------------------------------------------------------------------------------------------------------------
Meat products, Sec. 170.3(n)(29) of this chapter. 5.0 percent
----------------------------------------------------------------------------------------------------------------
Milk products, Sec. 170.3(n)(31) of this chapter. 5.0 percent
----------------------------------------------------------------------------------------------------------------
Nonalcoholic beverages, Sec. 170.3(n)(3) of this 0.5 percent
chapter.
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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
----------------------------------------------------------------------------------------------------------------
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
----------------------------------------------------------------------------------------------------------------
Soft candy, Sec. 170.3(n)(38) of this chapter. 4.0 percent
----------------------------------------------------------------------------------------------------------------
Soup mixes, Sec. 170.3(n)(40) of this chapter. 3.0 percent
----------------------------------------------------------------------------------------------------------------
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
