[Federal Register Volume 69, Number 10 (Thursday, January 15, 2004)]
[Proposed Rules]
[Pages 2313-2317]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-811]


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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: Tentative final rule.

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SUMMARY: The Food and Drug Administration (FDA) is issuing a tentative 
final rule to amend its regulations by reallocating the uses of 
menhaden oil in food that currently are established in Sec.  184.1472 
(21 CFR 184.1472). FDA has tentatively concluded that these uses of 
menhaden oil are generally recognized as safe (GRAS), but only when the 
menhaden oil is not used in combination with other added oils that are 
significant sources of eicosapentaenoic acid (EPA) and docosahexaenoic 
acid (DHA). Because FDA's proposed rule of February 26, 2002, did not 
include a condition of use for other added oils, FDA is issuing this 
tentative final rule to give interested persons an opportunity to 
comment on this use limitation.

DATES: Submit written or electronic comments by March 30, 2004.

ADDRESSES: Submit written comments to the Division of Dockets 
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, 
rm. 1061, Rockville, MD 20852. Submit electronic comments to http://www.fda.gov/dockets/ecomments.

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, 202-418-3095.

SUPPLEMENTARY INFORMATION:

I. Background

    Menhaden oil is a refined marine oil that is derived from menhaden 
fish (Brevoortia species). Menhaden oil differs from edible vegetable 
oils and animal fats in its high proportion of polyunsaturated fatty 
acids, including omega-3 fatty acids. EPA and DHA are the major source 
of omega-3 fatty acids from fish oil and together comprise 
approximately 20 percent by weight of menhaden oil. In response to a 
petition (GRASP 6G0316) from the National Fish Meal and Oil 
Association, FDA issued a final rule on June 5, 1997 (62 FR 30751)

[[Page 2314]]

(the June 1997 final rule), affirming menhaden oil as 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 discussed in the following paragraphs, the maximum limit of 3.0 g/p/
d on the total daily intake of EPA and DHA is a safeguard against the 
possible 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 (LDL) cholesterol. The concerns over 
possible adverse effects of fish oil consumption on bleeding time, 
glycemic control, and LDL cholesterol were discussed in the June 1997 
final rule.
    As part of FDA's evaluation of GRASP 6G0316, FDA examined the 
scientific literature for evidence that consumption of fish oils may 
contribute to excessive bleeding. In the June 1997 final rule, FDA 
concluded based on this examination of the scientific literature, 
including more than 50 reports on fish oils with data on bleeding time, 
that when consumption of fish oils is limited to 3.0 g/p/d or less of 
EPA and DHA, there is no significant risk for increased bleeding time 
beyond the normal range (62 FR 30751 at 30752 to 30753). FDA also 
concluded that amounts of fish oils providing more than 3.0 g/p/d of 
EPA and DHA have generally been found to produce increases in bleeding 
time that are statistically significant, but that there are 
insufficient data to evaluate the clinical significance of this 
finding. Therefore, because of the lack of data on clinical 
significance and because of the potential risk of excessive bleeding in 
some individuals with intakes at higher levels, FDA concluded that the 
safety of menhaden oil was generally recognized only at levels that 
limit intake of EPA and DHA to 3.0 g/p/d.
    FDA also concluded in the June 1997 final rule that 3.0 g/p/d of 
EPA and DHA is a safe level with respect to glycemic control (62 FR 
30751 at 30753). This conclusion was based on FDA's review of a series 
of studies on non-insulin-dependent diabetics. Studies on type-II 
diabetics that reported increased glucose used higher amounts (4.5 to 8 
g/p/d) of omega-3 fatty acids. One study found no change in fasting 
blood glucose levels among type-II (non-insulin-dependent) diabetics 
treated with 3.0 g/p/d EPA plus DHA for 2 weeks. Two other studies that 
used 3.0 g/p/d EPA plus DHA for 6 weeks and 2.7 g/p/d EPA plus DHA for 
8 weeks found only transient increases in blood glucose halfway through 
their respective supplementation periods. Another study that used 3.0 
g/p/d EPA plus DHA for 3 weeks found comparable increases in fasting 
blood glucose when either fish oil or safflower oil was fed, so the 
increase cannot be attributed specifically to omega-3 fatty acids. A 
study that compared the effects of fish oil and olive oil fed 3.0 g/p/d 
of EPA plus DHA did not find a difference in fasting glucose or 
glycosylated hemoglobin after fish oil supplementation compared to 
baseline; they did find a significant difference compared to the olive 
oil treatment, which produced changes in the opposite direction from 
fish oil. Based on its evaluation of the available information, FDA 
concluded in the June 1997 final rule that consumption of EPA and DHA 
in fish oils at 3.0 g/p/d by diabetics has no clinically significant 
effect on glycemic control, although higher amounts of EPA and DHA (4.5 
g/p/d and above) remain of concern.
    The June 1997 final rule also considered the reported effects of 
fish oil on LDL cholesterol levels in healthy persons with normal 
cholesterol levels, as well as in persons with diabetes mellitus, 
hypertension, abnormal blood lipid levels, and cardiovascular disease 
(62 FR 30751 at 30753 to 30754). As a result of its evaluation, FDA 
found that although reported study reports are variable, there appears 
to be a trend toward increased LDL cholesterol values with increased 
fish oil consumption in all population subgroups, with the magnitude of 
the increase appearing greater and more consistent in populations with 
abnormal blood lipid levels, hypertension, diabetes, and cardiovascular 
disease. Based on its evaluation, FDA concluded that 3.0 g/p/d of EPA 
and DHA is a safe level with respect to LDL cholesterol.
    In the Federal Register of February 26, 2002 (67 FR 8744), FDA 
published a proposed rule to amend Sec.  184.1472 by reallocating the 
uses of menhaden oil in food, while maintaining the total daily intake 
of EPA and DHA from menhaden oil at a level not exceeding 3.0 g/p/d. 
The proposal was based on a citizen petition from the National Fish 
Meal and Oil Association. 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 discussed in the June 1997 final rule and the February 2002 
proposed rule. 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.
    The purpose of the maximum use levels of menhaden oil in the food 
categories is to ensure that the total daily intake of EPA and DHA does 
not exceed 3.0 g/p/d (67 FR 8744 to 8745). When the June 1997 final 
rule published affirming that menhaden oil is GRAS for use as a direct 
human food ingredient with specific limitations, FDA considered food 
sources of EPA and DHA likely to be in the diet at that time, but the 
agency did not take into account that other sources of EPA and DHA 
might be developed in the future. The implicit basis for the 
restrictions in the menhaden oil regulation was that while menhaden oil 
might be blended with other oils to make a particular food product, the 
sum of DHA and EPA would not exceed 3.0 g/p/d because other oils were 
not significant sources of DHA and EPA. However, since publication of 
the proposed rule, FDA has received notices from three companies that 
have concluded that fish oils, other than menhaden oil, are GRAS for 
use in the same food categories as those currently listed in Sec.  
184.1472(a)(3) at maximum use levels that are designed to assure that 
the combined daily intake of EPA and DHA would not exceed 3.0 g/p/d. 
These oils included small planktivorous pelagic fish body oil (oil 
derived primarily from sardine and anchovy fish) (Ref. 1), a fish oil 
concentrate (manufactured from oil extracted from edible marine fish 
species that normally include anchovy, sardine, jack mackerel, and 
mackerel) (Ref. 2), and tuna oil (Ref. 3). In each case, the company 
acknowledged the concerns raised by FDA in the June 1997 final rule and 
the proposed rule, about consumption of high levels of EPA and DHA. 
Furthermore, in each case the company stated that its determination of 
GRAS status related only to the circumstance where its fish oil product 
is used as the sole added source of EPA and DHA in any given food 
category and is not combined or augmented with any other EPA/DHA-rich 
oil.
    Because of developing interest in food ingredients that are sources 
of EPA and DHA, FDA now believes that it is necessary to state 
explicitly in the regulation that when menhaden oil is added as an 
ingredient in foods, it may

[[Page 2315]]

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. Because this use restriction was 
not contained in the proposed rule, FDA is issuing this regulation as a 
tentative final rule under 21 CFR 10.40(f)(6). FDA will review any 
comments that are relevant to this condition of use and that are 
received within the 75-day comment period and will respond accordingly 
to these comments in the Federal Register.
    FDA is also making an editorial update to Sec.  184.1472(a)(2)(iii) 
to reflect that the name for the Office of Premarket Approval has been 
changed to the Office of Food Additive Safety.

II. Comments on the Proposed Rule

    The agency provided 75 days for comments on the proposed rule. At 
the close of the comment period, the agency had received two comments 
that expressed concern regarding the environmental impact of the 
proposed rule. These two comments are addressed separately in section 
III of this document. The agency also received comments that were 
submitted from a fish oil company and a trade association that 
represents the fish oil industry that merely expressed general support 
for the agency's proposed rule. The other comments were from individual 
consumers who were opposed to the proposed rule.
    Most of the comments FDA received expressing opposition to the 
proposed rule objected to declaring menhaden oil on food labels by the 
name ``omega-3 fatty acids'' or a variation of this name. Many of these 
comments asserted that ``omega-3 fatty acids'' is a misleading name for 
menhaden oil. Some comments were from vegetarians and vegans who stated 
that listing menhaden oil by the name ``omega-3 fatty acids'' will make 
it difficult for them to avoid this animal product in foods. There were 
also comments that stated that listing menhaden oil by the name 
``omega-3 fatty acids'' will make it difficult for those with fish 
allergies to avoid this fish oil in foods.
    The proposed rule did not address how menhaden oil is to be listed 
as an ingredient on food labels. Generally, under section 403(i)(2) of 
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 343(i)(2)), a food 
is misbranded unless its label bears the common or usual name of each 
ingredient. Although menhaden oil is a significant source of omega-3 
fatty acids, FDA knows of no basis for considering omega-3 fatty acids 
to be its common or usual name. Any consideration of an alternative 
name for menhaden oil, such as ``omega-3 fatty acids,'' is outside the 
scope of the proposed rule.
    FDA also received comments from consumers asking the agency to 
consider the use of omega-3 fatty acids from sources other than 
menhaden fish, such as flax seed. FDA notes that although menhaden oil 
does contain omega-3 fatty acids (primarily EPA and DHA), omega-3 fatty 
acids are not the subject of the proposed rule. Therefore, the use of 
other oils is outside the scope of the proposed rule.
    A few comments stated that the menhaden fish is unsuitable for 
human consumption and, therefore, oil from this fish should not be used 
as a food ingredient. As stated in the proposed rule, menhaden oil is 
already affirmed as generally recognized as safe as a direct human food 
ingredient (Sec.  184.1472). FDA has not received any new information 
or comments that would alter its previous determination that menhaden 
oil that meets the specifications in Sec.  184.1472 is generally 
recognized as safe for use in food under the conditions specified.
    Some of the comments FDA received expressing opposition to the 
proposed rule were against the addition of menhaden oil to foods 
because of a concern about the possibility of high levels of 
contaminants in the menhaden oil due to bioaccumulation of these 
contaminants in the menhaden fish. Bioaccumulation describes the 
process that results in an increase in the concentration of a chemical 
in a biological organism over time, compared to the chemical's 
concentration in the environment. FDA has evaluated data on levels of 
various chemical contaminants, such as pesticides, polychlorinated 
biphenyls and dioxins in menhaden oil. Based on these data, FDA finds 
no basis for a safety concern from food uses of menhaden oil due to 
possible bioaccumulation of lipophilic chemical contaminants in the 
source fish.

III. Environmental Impact

    The agency received two comments expressing concern about the 
impact that the proposed rule will have on the menhaden fish 
population. One comment asked whether this action will result in the 
``near extinction'' of menhaden, mackerel, and sardines, and further 
asked how near extinction, if it results, would effect ocean 
ecosystems. The other comment asserted that menhaden are being 
overfished to extinction, and that because of their population decline, 
larger game fish populations off the Atlantic coast are dropping 
proportionately. Neither comment cited supporting data or information.
    To ensure that the maximum sustainable yield of menhaden is not 
exceeded and to provide long-term production, the menhaden fisheries 
are monitored by the Atlantic and Gulf States Marine Fisheries 
Commissions (which are under the jurisdiction of the National Marine 
Fisheries Service (NMFS)), as well as by State authorities. If there is 
a threat to the long-term yield of a fishery, generally, limits will be 
imposed by these organizations. At present, the Atlantic and Gulf 
menhaden fisheries are considered to be healthy and not overfished. 
With regard to the impact that the proposed rule will have on mackerel 
and sardines, the United Nation's Foreign Agricultural Organization 
reports that the primary practice used to catch menhaden has one of the 
lowest discard ratios of any method for general commercial fishing. 
(Less than 3 percent by weight of the total menhaden catch are other 
species of fish.) In addition, NMFS reports a numerical bycatch 
incidence (i.e., fish that are unintentionally caught) of less than 0.1 
percent for the menhaden fishing industry. For these reasons, the 
agency does not believe that the proposed rule would result in 
overfishing of menhaden or have a significant impact on other species 
of fish. In summary, the comments do not provide a basis on which to 
change the conclusions of the environmental analysis that was prepared 
for the proposed rule, as discussed in the following paragraph.
    The agency has previously considered the environmental effects of 
affirming menhaden oil as GRAS as a direct human food ingredient, 
provided that the combined daily intake of EPA and DHA from menhaden 
oil does not exceed 3.0 g/p/d (62 FR 30751 at 30754). The analysis 
assumed that the maximum use levels would be completely used for each 
food category and concluded that this action will not have a 
significant impact on the menhaden population. This rule will 
reallocate the maximum levels among food categories but will not 
increase the total maximum allowable level. Therefore, our previous 
analysis is applicable. 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.

[[Page 2316]]

IV. Analysis of Economic Impacts

A. Final Regulatory Impact Analysis

    FDA has examined the economic implications of this tentative final 
rule as required by Executive Order 12866. Executive Order 12866 
directs agencies to assess all costs and benefits of available 
regulatory alternatives and, when regulation is necessary, to select 
regulatory approaches that maximize net benefits (including potential 
economic, environmental, public health and safety, and other 
advantages; distributive impacts; and equity). Executive Order 12866 
classifies a rule as significant if it meets any one of a number of 
specified conditions, including: having an annual effect on the economy 
of $100 million, adversely affecting a sector of the economy in a 
material way, adversely affecting competition, or adversely affecting 
jobs. A regulation is also considered a significant regulatory action 
if it raises novel legal or policy issues. FDA has determined that this 
tentative final rule is not a significant regulatory action as defined 
by Executive Order 12866.
    In the economic analysis of the proposed rule, we stated that the 
main benefit of this rule would be the expansion of the potential uses 
of menhaden oil made possible by the new maximum levels. Firms choosing 
to use menhaden oil will bear labeling and other costs. Because these 
costs are voluntary, they will be borne only if doing so is anticipated 
to be advantageous to the firm. Although firms making products that now 
use menhaden oil at levels below the current maximum but above the new 
maximum could bear potential compliance costs, we noted in the proposed 
rule that FDA did not know of any products in that category. We 
received no comments on this conclusion, or on any other part of the 
preliminary regulatory impact analysis.

B. Final Regulatory Flexibility Analysis

    FDA has examined the economic implications of this tentative final 
rule as required by the Regulatory Flexibility Act (5 U.S.C. 601-612). 
If a rule has a significant economic impact on a substantial number of 
small entities, the Regulatory Flexibility Act requires agencies to 
analyze regulatory options that would lessen the economic effect of the 
rule on small entities. FDA finds that this tentative final rule would 
not have a significant economic impact on a substantial number of small 
entities.
    The use of the menhaden oil by any small business is voluntary and 
will be undertaken only if doing so is anticipated to be advantageous 
to the small business. Small businesses would only bear a compliance 
cost if, as stated previously, they make products that are below the 
current maximum but above the new maximum.
    The agency specifically requested comments from small businesses on 
its assumption that no small businesses make products that will be 
affected by reducing the maximum levels of menhaden oil in pies, cakes, 
fats, oils, fish products, and meat products. We received no comments 
on that assumption or any other part of the initial regulatory 
flexibility analysis.

C. Unfunded Mandates

    Title II of the Unfunded Mandates Reform Act of 1995 (Public Law 
104-4) requires cost-benefit and other analyses before any rulemaking 
if the rule would include a ``Federal mandate that may result in the 
expenditure by State, local, and tribal governments, in the aggregate, 
or by the private sector, of $100,000,000 or more (adjusted annually 
for inflation) in any 1 year.'' The current inflation-adjusted 
statutory threshold is $112 million. FDA has determined that this 
tentative final rule does not constitute a significant rule under the 
Unfunded Mandates Reform Act.

V. Paperwork Reduction Act

    This tentative final rule contains no collections of information. 
Therefore, clearance by the Office of Management and Budget under the 
Paperwork Reduction Act of 1995 is not required.

VI. Federalism

    FDA has analyzed this tentative final rule in accordance with the 
principles set forth in Executive Order 13132. FDA has determined that 
the tentative final rule does not contain policies that have 
substantial direct effects on the States, on the relationship between 
the National Government and the States, or on the distribution of power 
and responsibilities among the various levels of government. Because 
the agency concludes that this tentative final rule does not contain 
policies that have federalism implications as defined in the order, a 
federalism summary impact statement is not required.

VII. Comments

    Interested person may submit to the Division of Dockets Management 
(see ADDRESSES) written or electronic comments regarding this document. 
Submit a single copy of electronic comments or two paper copies of any 
mailed comments, except that individuals may submit one paper copy. 
Comments are to be identified with the docket number found in the 
brackets in the heading of this document. Received comments may be seen 
in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday 
through Friday.

VIII. References

    The following references have been placed on display in the 
Division of Dockets Management (see ADDRESSES) and may be seen by 
interested persons between 9 a.m. and 4 p.m., Monday through Friday.
    1. GRAS notice GRN 000102, including the response letter to GRN 
000102 dated September 3, 2002, from Alan M. Rulis of FDA to Edward 
Iorio of Jedwards International, available at http://
www.cfsan.fda.gov/[tilde]rdb/opa-gras.html.
    2. GRAS notice GRN 000105, including the response letter to GRN 
000105 dated October 15, 2002, from Alan M. Rulis of FDA to Nancy L. 
Schnell of Unilever United States, Inc., available at http://
www.cfsan.fda.gov/[tilde]rdb/opa-gras.html.
    3. GRAS notice GRN 000109, including the response letter to GRN 
000109 dated December 4, 2002, from Alan M. Rulis of FDA to Anthony 
Young of Piper Rudnick, LLP, available at http://www.cfsan.fda.gov/
[tilde]rdb/opa-gras.html.

List of Subjects in 21 CFR Part 184

    Food additives.
    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, it is proposed that 21 CFR part 184 be amended as follows:

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

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

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

    2. Section 184.1472 is amended by revising paragraph (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,

[[Page 2317]]

5100 Paint Branch Pkwy., College Park, MD 20740, or at the Office of 
the Federal Register, 800 North Capitol St. NW., suite 700, Washington, 
DC.
* * * * *
    (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:

------------------------------------------------------------------------
                                               Maximum level of use in
              Category of food                     food (as served)
------------------------------------------------------------------------
Baked goods, baking mixes, Sec.              5.0 percent
 170.3(n)(1) of this chapter.
------------------------------------------------------------------------
Cereals, Sec.   170.3(n)(4) of this          4.0 percent
 chapter.
------------------------------------------------------------------------
Cheese products, Sec.   170.3(n)(5) of this  5.0 percent
 chapter.
------------------------------------------------------------------------
Chewing gum, Sec.   170.3(n)(6) of this      3.0 percent
 chapter.
------------------------------------------------------------------------
Condiments, Sec.   170.3(n)(8) of this       5.0 percent
 chapter.
------------------------------------------------------------------------
Confections, frostings, Sec.   170.3(n)(9)   5.0 percent
 of this chapter.
------------------------------------------------------------------------
Dairy product analogs, Sec.   170.3(n)(10)   5.0 percent
 of this chapter.
------------------------------------------------------------------------
Egg products, Sec.   170.3(n)(11) of this    5.0 percent
 chapter.
------------------------------------------------------------------------
Fats, oils, Sec.   170.3(n)(12) of this      12.0 percent
 chapter, but not in infant formula.
------------------------------------------------------------------------
Fish products, Sec.   170.3(n)(13) of this   5.0 percent
 chapter.
------------------------------------------------------------------------
Frozen dairy desserts, Sec.   170.3(n)(20)   5.0 percent
 of this chapter.
------------------------------------------------------------------------
Gelatins, puddings, Sec.   170.3(n)(22) of   1.0 percent
 this chapter.
------------------------------------------------------------------------
Gravies, sauces, Sec.   170.3(n)(24) of      5.0 percent
 this chapter.
------------------------------------------------------------------------
Hard candy, Sec.   170.3(n)(25) of this      10.0 percent
 chapter.
------------------------------------------------------------------------
Jams, jellies, Sec.   170.3(n)(28) of this   7.0 percent
 chapter.
------------------------------------------------------------------------
Meat products, Sec.   170.3(n)(29) of this   5.0 percent
 chapter.
------------------------------------------------------------------------
Milk products, Sec.   170.3(n)(31) of this   5.0 percent
 chapter.
------------------------------------------------------------------------
Nonalcoholic beverages, Sec.   170.3(n)(3)   0.5 percent
 of this chapter.
------------------------------------------------------------------------
Nut products, Sec.   170.3(n)(32) of this    5.0 percent
 chapter.
------------------------------------------------------------------------
Pastas, Sec.   170.3(n)(23) of this          2.0 percent
 chapter.
------------------------------------------------------------------------
Plant protein products, Sec.   170.3(n)(33)  5.0 percent
 of this chapter.
------------------------------------------------------------------------
Poultry products, Sec.   170.3(n)(34) of     3.0 percent
 this chapter.
------------------------------------------------------------------------
Processed fruit juices, Sec.   170.3(n)(35)  1.0 percent
 of this chapter.
------------------------------------------------------------------------
Processed vegetable juices, Sec.             1.0 percent
 170.3(n)(36) of this chapter.
------------------------------------------------------------------------
Snack foods, Sec.   170.3(n)(37) of this     5.0 percent
 chapter.
------------------------------------------------------------------------
Soft candy, Sec.   170.3(n)(38) of this      4.0 percent
 chapter.
------------------------------------------------------------------------
Soup mixes, Sec.   170.3(n)(40) of this      3.0 percent
 chapter.
------------------------------------------------------------------------
Sugar substitutes, Sec.   170.3(n)(42) of    10.0 percent
 this chapter.
------------------------------------------------------------------------
Sweet sauces, toppings, syrups, Sec.         5.0 percent
 170.3(n)(43) of this chapter.
------------------------------------------------------------------------
White granulated sugar, Sec.   170.3(n)(41)  4.0 percent
 of this chapter.
------------------------------------------------------------------------

    (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: January 6, 2004.
L. Robert Lake,
Director, Office of Regulations and Policy, Center for Food Safety and 
Applied Nutrition.
[FR Doc. 04-811 Filed 1-14-04; 8:45 am]
BILLING CODE 4160-01-S