[Federal Register Volume 67, Number 38 (Tuesday, February 26, 2002)]
[Proposed Rules]
[Pages 8744-8748]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-4327]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 184

[Docket No. 99P-5332]


Substances Affirmed as Generally Recognized as Safe: Menhaden Oil

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed rule.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is proposing to amend 
its regulation on menhaden oil which has been affirmed as generally 
recognized as safe (GRAS) as a direct human food ingredient with 
specific limitations. FDA is proposing to reallocate the uses of 
menhaden oil in food that currently are established in FDA's 
regulations. This proposal responds to a citizen petition on menhaden 
oil from the National Fish Meal and Oil Association (NFMOA).

DATES: Submit written or electronic comments by May 13, 2002.

ADDRESSES: Submit written comments to the Dockets Management Branch 
(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: Lawrence J. Lin, Center for Food 
Safety and Applied Nutrition (HFS-215), Food and Drug Administration, 
5100 Paint Branch Pkwy., College Park, MD 20740-3835, 202-418-3103.

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of June 5, 1997 (62 FR 30751), FDA 
published a final rule to affirm that menhaden oil is GRAS for use as a 
direct human food ingredient with specific limitations (hereinafter 
referred to as the June 1997 final rule). FDA published the June 1997 
final rule in response to a GRAS petition (GRASP 6G0316) submitted by 
the NFMOA. FDA concluded in the June 1997 final rule that, based on 
scientific procedures (including published and other information), the 
use of menhaden oil as a direct human food ingredient is safe, provided 
that the combined daily intake of eicosapentaenoic acid (EPA) and 
docosahexaenoic acid (DHA) from menhaden oil does not exceed 3.0 grams 
per person per day (g/p/d).
    Affirming the GRAS status of menhaden oil with specific limitations 
(Sec. 184.1(b)(2) (21 CFR 184.1(b)(2))) was necessary because of the 
agency's concerns over possible adverse effects of fish oils on 
bleeding time (the time taken for bleeding from a standardized skin 
wound to cease), glycemic control, and low-density lipoprotein 
cholesterol. These issues were discussed fully in the June 1997 final 
rule.

II. The Citizen Petition

    The NFMOA has submitted a citizen petition (Docket No. 99P-5332) 
under 21 CFR 10.20 and 10.30 requesting that the agency amend 
Sec. 184.1472 Menhaden oil (21 CFR 184.1472) by reallocating the

[[Page 8745]]

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 maximum limit of 3.0 g/p/d on the total daily intake of EPA and DHA 
has been considered a reasonable safeguard against the possible adverse 
effects stated above and to date no new information available has 
caused the agency to alter this limit. The reallocation is performed 
by: (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, for 
example, cookies and crackers, breads and rolls, fruit pies and custard 
pies, and cakes, and including them under broader food categories, 
i.e., baked goods and baking mixes.
    Table 1 shows the current maximum levels of use of menhaden oil in 
the currently listed food categories as established in 
Sec. 184.1472(a)(3).

         Table 1.--Current Maximum Levels of Use of Menhaden Oil
------------------------------------------------------------------------
                                                       Current maximum
                Category of food\1\                 level of use in food
                                                         (as served)
------------------------------------------------------------------------
Cookies and crackers (1)..........................           5.0 percent
Breads and rolls (white and dark) (1).............           1.0 percent
Fruit pies and custard pies (1)...................           7.0 percent
Cakes (1).........................................          10.0 percent
Cereals (4).......................................           4.0 percent
Fats and oils (12), but not in infant formula.....          20.0 percent
Yogurt (31).......................................           4.0 percent
Cheese products (5)...............................           5.0 percent
Frozen dairy products (20)........................           5.0 percent
Meat products (29)................................          10.0 percent
Egg products (11).................................           5.0 percent
Fish products (13)................................          20.0 percent
Condiments (8)....................................           5.0 percent
Soup mixes (40)...................................           3.0 percent
Snack foods (37)..................................           5.0 percent
Nut products (32).................................           5.0 percent
Gravies and sauces (24)...........................           5.0 percent
------------------------------------------------------------------------
\1\The number in parenthesis following each food category is the
  paragraph listing of that food category in Sec.  170.3(n) (21 CFR
  170.3(n)).

    Table 2 shows the new maximum levels of use of menhaden oil in the 
currently listed food categories plus new food categories, as proposed 
by the NFMOA.

           Table 2.--New Maximum Levels of Use of Menhaden Oil
------------------------------------------------------------------------
                                                      Proposed maximum
                Category of food\1\                     level of use
------------------------------------------------------------------------
Baked goods and baking mixes (1)..................           5.0 percent
Cereals (4).......................................           4.0 percent
Cheese products (5)...............................           5.0 percent
Condiments (8)....................................           5.0 percent
Egg products (11).................................           5.0 percent
Fats and oils (12), but not in infant formula.....          12.0 percent
Fish products (13)................................           5.0 percent
Frozen dairy desserts (20)........................           5.0 percent
Gravies and sauces (24)...........................           5.0 percent
Meat products (29)................................           5.0 percent
Milk products (31)................................           5.0 percent
Nut products (32).................................           5.0 percent
Snack foods (37)..................................           5.0 percent
Soup mixes (40)...................................           3.0 percent
Nonalcoholic beverages (3)........................           0.5 percent
Chewing gum (6)...................................           3.0 percent
Confections and frostings (9).....................           5.0 percent
Dairy product analogs (10)........................           5.0 percent
Gelatins and puddings (22)........................           1.0 percent
Pastas (23).......................................           2.0 percent
Hard candy (25)...................................          10.0 percent
Jams and jellies (28).............................           7.0 percent
Plant protein products (33).......................           5.0 percent
Poultry products (34).............................           3.0 percent
Processed fruit juices (35).......................           1.0 percent
Processed vegetable juices (36)...................           1.0 percent
Soft candy (38)...................................           4.0 percent
White granulated sugar (41).......................           4.0 percent

[[Page 8746]]

 
Sugar substitutes (42)............................          10.0 percent
Sweet sauces, toppings, and syrups (43)...........           5.0 percent
------------------------------------------------------------------------
\1\The number in parenthesis following each food category is the
  paragraph listing of that food category in Sec.  170.3(n).

    As shown in table 1, the currently listed food categories include 
several subcategories, such as cookies and crackers, breads and rolls, 
fruit pies and custard pies, and cakes. These items are subcategories 
of baked goods and baking mixes as described under Sec. 170.3(n)(1). 
The proposed reallocation (in table 2) does not list any subcategory, 
but rather includes the food category baked goods and baking mixes, 
which would include all of these items. Also, the currently listed food 
categories include another subcategory, i.e., yogurt, a subcategory of 
milk product as described under Sec. 170.3(n)(31). Similarly, the 
proposed reallocation does not list yogurt, but rather includes the 
food category milk products, which would include yogurt.
    Although each food category in the proposed reallocation (table 2) 
is associated with a paragraph in Sec. 170.3(n), menhaden oil may not 
be added to all foods included in that paragraph, unless such food is 
listed in table 2. For example, Sec. 170.3(n)(23) includes grain 
products and pastas, but menhaden oil only could be added to pastas 
(not grain products) under this proposed reallocation in table 2. In 
other words, only the food categories that are listed in table 2 are 
those that the NFMOA is requesting for the amendment of the regulation 
on menhaden oil.
    The NFMOA has provided exposure analyses that contain estimates of 
EPA and DHA intake from menhaden oil for the revised uses of the 
currently listed food categories and the proposed uses of the new food 
categories. The NFMOA states that the estimated daily exposure to EPA 
and DHA from those uses of menhaden oil is 2.7 g/p/d. The NFMOA 
concludes that menhaden oil is GRAS for the revised uses of the 
currently listed food categories and the proposed uses of the new food 
categories, because the total daily intake of EPA and DHA from those 
uses of menhaden oil would not exceed 3.0 g/p/d, consistent with the 
June 1997 final rule.

III. Proposed Action

    Based on information in the citizen petition and other relevant 
material, FDA tentatively has determined that the GRAS status of 
menhaden oil with specific limitations remains unchanged if uses of 
menhaden oil in food are reallocated, because the total daily intake of 
EPA and DHA from menhaden oil from the revised uses of the currently 
listed food categories and the proposed uses of the new food categories 
would not exceed 3.0 g/p/d. Because not all foods in the marketplace 
within those food categories in table 2 would contain menhaden oil that 
substitutes for other edible fat or oil, and because not all foods that 
a consumer chooses daily would be those with menhaden oil used as a 
substitute oil, the actual total daily intake of EPA and DHA from 
menhaden oil for an average person should be significantly below 3.0 g/
p/d. Further, because the total daily intake of EPA and DHA from 
menhaden oil based on the uses proposed in this rulemaking would not 
exceed 3.0 g/p/d, and the agency is not aware of any new data and 
information that would prompt the agency to change the upper limit of 
safety of 3.0 g/p/d, FDA intends to rely on its safety determination 
from its prior GRAS affirmation for finding these uses safe. Therefore, 
the agency is proposing to amend the regulation on menhaden oil to 
reallocate its use in food.

IV. Environmental Impact

    The agency carefully has considered the potential environmental 
effects of this action. FDA tentatively has concluded that the action 
will not have a significant impact on the human environment, and that 
an environmental impact statement is not required. The agency's finding 
of no significant impact and the evidence supporting that finding, 
contained in an environmental assessment, may be seen in the Dockets 
Management Branch (address above) between 9 a.m. and 4 p.m., Monday 
through Friday.

V. Analysis of Economic Impacts

A. Preliminary Regulatory Impact Analysis

    FDA has examined the economic implications of this proposed 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 also is considered a significant regulatory action if it 
raises novel legal or policy issues. FDA has determined that this 
proposed rule is not a significant regulatory action as defined by 
Executive Order 12866.
    FDA is proposing to amend its regulation on menhaden oil, which the 
agency believes is GRAS with specific limitations. This proposed rule 
would reallocate the uses of menhaden oil in food, without causing the 
combined daily intake of EPA and DHA from menhaden oil to exceed 3.0 g/
p/d.
    The main benefit of this proposed rule would be the expansion of 
the potential uses of menhaden oil as proposed in table 2. Firms 
choosing to use menhaden oil would 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.
    FDA proposes to reduce maximum use levels of menhaden oil for pies, 
cakes, fats, oils, fish products, and meat products. The potential 
compliance costs of this proposed rule would be borne by firms making 
products that now use menhaden oil at levels below the current maximum 
but above the proposed maximum. The proposed rule would force them to 
either reformulate their products or cease production. Although the 
potential cost of both reformulation and ceasing production may be 
large, FDA does not know of any products that would be forced to bear 
these costs. Using menhaden oil in pies, cakes, fats, oils, fish 
products, and meat products at the current maximum levels leads to 
products with undesirable flavors. Based on both market observations 
and taste, FDA assumes that no products currently contain levels of 
menhaden oil above the proposed maximum levels and thus

[[Page 8747]]

there are no costs associated with reformulation or ceasing production 
based on this proposal. We request comments on this assumption.

B. Initial Regulatory Flexibility Analysis

    FDA has examined the economic implications of this proposed 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 is proposing to amend the GRAS affirmation for menhaden oil by 
establishing new maximum levels of use. The use of the menhaden oil by 
any small business is voluntary and is undertaken only if anticipated 
to be advantageous to the small business. Small businesses would only 
bear a compliance cost if, as stated above, they make products that are 
below the current maximum but above the proposed maximum levels of use. 
The proposed rule would force them to either reformulate their products 
or cease production. Although the potential cost of both reformulation 
and ceasing production to small businesses may be large, FDA does not 
know of any small businesses that would be forced to bear these costs. 
Using menhaden oil in pies, cakes, fats, oils, fish products, and meat 
products at the current maximum levels leads to products with 
undesirable flavors. Based on both market observations and taste, FDA 
assumes that no products currently contain levels of menhaden oil above 
the proposed maximum levels and thus there are no costs associated with 
reformulation or ceasing production based on this proposal. The agency 
therefore tentatively concludes that the new maximum levels proposed 
would not impose significant costs on a substantial number of small 
entities. The agency requests comments from small businesses on this 
assumption. Based on the assumption that no small businesses make 
products that would be affected by reducing the maximum levels of 
menhaden oil in pies, cakes, fats, oils, fish products, and meat 
products, FDA finds that this proposed rule would not have a 
significant economic impact on a substantial number of small entities.

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 $110 million. FDA has determined that this 
proposed rule does not constitute a significant rule under the Unfunded 
Mandates Reform Act of 1995.

VI. Paperwork Reduction Act of 1995

    This proposed 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.

VII. Federalism Impact

    FDA has analyzed this proposed rule in accordance with the 
principles set forth in Executive Order 13132. FDA has tentatively 
determined that the proposed 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. The agency 
invites comments on its tentative conclusion that the proposed rule 
does not contain policies that have federalism implications as defined 
in the order, and consequently, a federalism summary impact statement 
is not required.

VIII. Comments

    Interested persons may submit to the Dockets Management Branch 
(address above) written comments regarding this proposed rule by May 
13, 2002. Two copies of any comments are to be submitted, except that 
individuals may submit one copy. Submit electronic comments to http://www.fda.gov/dockets/ecomments. Comments are to be identified with the 
docket number found in brackets in the heading of this document. 
Received comments may be seen in the Dockets Management Branch between 
9 a.m. and 4 p.m., Monday through Friday.

List of Subjects in 21 CFR Part 184

    Food additives, Food ingredients.

    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)(3) to read 
as follows:


Sec. 184.1472  Menhaden oil.

    (a) * * * 
    (3) In accordance with Sec. 184.1(b)(2), the ingredient may be used 
in food only within the following specific limitations:

------------------------------------------------------------------------
                                                    Maximum level of use
                 Category of food                    in food (as served)
------------------------------------------------------------------------
Baked goods, baking mixes, Sec.  170.3(n)(1) of              5.0 percent
 this chapter.....................................
Cereals, Sec.  170.3(n)(4) of this chapter........           4.0 percent
Cheese products, Sec.  170.3(n)(5) of this                   5.0 percent
 chapter..........................................
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..........................................
Dairy product analogs, Sec.  170.3(n)(10) of this            5.0 percent
 chapter..........................................
Egg products, Sec.  170.3(n)(11) of this chapter..           5.0 percent
Fats, oils, Sec.  170.3(n)(12) of this chapter,             12.0 percent
 but 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..........................................
Gelatins, puddings, Sec.  170.3(n)(22) of this               1.0 percent
 chapter..........................................
Gravies, sauces, Sec.  170.3(n)(24) of this                  5.0 percent
 chapter..........................................
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

[[Page 8748]]

 
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..........................................
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
Plant protein products, Sec.  170.3(n)(33) of this           5.0 percent
 chapter..........................................
Poultry products, Sec.  170.3(n)(34) of this                 3.0 percent
 chapter..........................................
Processed fruit juices, Sec.  170.3(n)(35) of this           1.0 percent
 chapter..........................................
Processed vegetable juices, Sec.  170.3(n)(36) of            1.0 percent
 this chapter.....................................
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..........................................
Sweet sauces, toppings, syrups, Sec.  170.3(n)(43)           5.0 percent
 of this chapter..................................
White granulated sugar, Sec.  170.3(n)(41) of this           4.0 percent
 chapter..........................................
------------------------------------------------------------------------

* * * * *

    Dated: January 11, 2002.
L. Robert Lake,
Director of Regulations and Policy, Center for Food Safety and Applied 
Nutrition.
[FR Doc. 02-4327 Filed 2-25-02; 8:45 am]
BILLING CODE 4160-01-S