Substances Affirmed as Generally Recognized as Safe
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[Federal Register: February 26, 2002 (Volume 67, Number 38)]
[Proposed Rules]
[Page 8744-8748]
>From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr26fe02-17]
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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.
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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 <A
HREF="http://www.fda.gov/dockets/ecomments">http://www.fda.gov/
dockets/ecomments</A>.
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
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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 <A
HREF="http://www.fda.gov/dockets/ecomments">http://
www.fda.gov/dockets/ecomments</A>. 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)
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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..........................................
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* * * * *
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
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