[Federal Register Volume 59, Number 100 (Wednesday, May 25, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-12804]


[[Page Unknown]]

[Federal Register: May 25, 1994]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES
21 CFR Part 166

[Docket No. 90P-0025]

 

Margarine; Standard of Identity To Permit Use of Any Form of Oil 
of Marine Species Affirmed as GRAS or Approved as a Food Additive for 
This Use

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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SUMMARY: The Food and Drug Administration (FDA) is amending the U.S. 
standard of identity for margarine to permit the use of any form of oil 
of marine species that has been affirmed as generally recognized as 
safe (GRAS) or approved as a food additive for this use. This action is 
in response to a petition submitted by the National Fish Meal and Oil 
Association (NFMOA). FDA believes that this action will provide 
increased flexibility to manufacturers in the selection of lipid 
ingredients in margarine and will promote honesty and fair dealing in 
the interest of consumers.

DATES: Effective July 25, 1994. All products initially introduced or 
initially delivered for introduction into interstate commerce shall 
comply on or after this date.

FOR FURTHER INFORMATION CONTACT: Nannie H. Rainey, Center for Food 
Safety and Applied Nutrition (HFS-158), Food and Drug Administration, 
200 C St. SW., Washington, DC 20204, 202-205-5099.

SUPPLEMENTARY INFORMATION:

I. The Proposal

    In the Federal Register of August 30, 1990 (55 FR 35439), FDA 
published a proposal based on a petition from NFMOA, 1525 Wilson Blvd., 
suite 500, Arlington, VA 22209, to amend the U.S. standard of identity 
for margarine (Sec. 166.110 (21 CFR 166.110)) to permit the use of any 
form of marine oil that has been affirmed as GRAS or approved as a food 
additive for this use as an additional optional edible fat or oil 
ingredient in margarine. Interested persons were given until October 
29, 1990, to submit comments.

II. The Tentative Final Rule

    The NFMOA petition was filed under section 701(e) of the Federal 
Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 371(e)), which 
requires formal rulemaking in any action for the amendment of a food 
standard. However, in November 1990, the Nutrition Labeling and 
Education Act of 1990 (Pub. L. 101-535) was signed into law, and it 
removed food standard rulemaking proceedings, except for actions for 
the amendment or repeal of food standards of identity for dairy 
products or maple sirup, from the formal rulemaking proceedings of 
section 701(e) of the act. Therefore, further action on the NFMOA 
petition would be subject to the informal notice and comment rulemaking 
proceedings of section 701(a) of the act. Thus, the agency published a 
tentative final rule in the Federal Register of August 17, 1993 (58 FR 
43580), under those procedures. Because there had been an opportunity 
to comment on the proposal when it was published in 1990, the comment 
period on that tentative final rule was 30 days.

III. Comments

    FDA received one comment in response to the tentative final rule. 
This comment, submitted by the petitioner, expressed support for the 
rule and urged the agency to finalize the rule as soon as possible. 
NFMOA also stated that it would like to make clear for the record that 
its petition did not ask FDA to approve the use of any form of marine 
oil but was instead restricted to ``any safe and suitable form of 
menhaden oil.'' The comment stated that, nevertheless, it had no 
objection to FDA's enlargement of the range of oils to be permitted by 
the amended regulation, from menhaden oil to marine oil, provided that 
this change does not result in any further delay in the rulemaking 
proceeding.
    The agency acknowledges that the petitioner only sought to provide 
for safe and suitable forms of menhaden oil in margarine. However, FDA 
believes that it is appropriate to provide for oil of any marine 
species where such oil has been affirmed as GRAS or approved as a food 
additive for this use. The broader provision in the standard of 
identity will eliminate the need to amend the standard of identity for 
margarine should other oils of marine species be found to be safe and 
suitable for use in this food. FDA also notes that ingredient labeling 
will inform consumers of the presence of such oils when used in 
margarine.
    Therefore, having received no adverse comments, the agency is 
revising the margarine standard as proposed in the tentative final 
rule. The agency believes that providing for optional oils of marine 
species that have been affirmed as GRAS or listed as a food additive 
for this use will increase manufacturers' options in the selection of 
oil ingredients for margarine and will provide for a wider variety of 
margarine products in the marketplace. Thus, the agency concludes that 
the proposed change in the standard of identity for margarine will 
promote honesty and fair dealing in the interest of consumers.
    Accordingly, after consideration of the comments, the agency is 
issuing this final rule to amend the standard of identity for margarine 
in Sec. 166.110 as set forth below.

IV. Economic Impact

    FDA has examined the economic implications of this final rule to 
amend the standard of identity for margarine in 21 CFR part 166 as 
required by Executive Order (E.O.) 12866 and the Regulatory Flexibility 
Act (Pub. L. 96-354). E.O. 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 effects, distributive impacts, and equity). The Regulatory 
Flexibility Act requires that the agency analyze options for regulatory 
relief for small businesses.
    In the August 17, 1993, tentative final rule, FDA announced that it 
had analyzed the economic impact of the new provision that FDA is 
adopting under the previous E.O. 12291 and found that it would not have 
a significant impact. E.O. 12291 compelled agencies to use cost-benefit 
analysis as a component of decisionmaking. The agency also tentatively 
concluded in the August 30, 1990, proposal that this action would not 
result in a significant economic impact on a substantial number of 
small entities. Manufacturers may continue to produce margarine using 
current formulations. Thus, no changes are required in formulations 
unless manufacturers wish to reformulate their products. FDA has 
received no new information or comments that would alter its tentative 
finding that there is no substantive economic issue in this rulemaking. 
Thus, FDA concludes that this is not a major rule as defined by E.O. 
12291, nor is it a significant rule as defined by E.O. 12866. In 
compliance with the Regulatory Flexibility Act, the agency certifies 
that the final rule will not have a significant impact on a substantial 
number of small businesses.

V. Environmental Impact

    In the preamble to the August 30, 1990, proposed rule, FDA reported 
its finding that this action qualified for categorical exclusion under 
21 CFR 25.24(b)(1) and that neither an environmental assessment (EA) 
nor an environmental impact statement was required. As noted in the 
tentative final rule, FDA received one comment on the proposed rule 
that claimed that this action would result in increased fishing 
pressure that could adversely affect the menhaden fishery, and that the 
agency had not considered this potential impact prior to issuing the 
proposed rule. Although the comment did not provide evidence to support 
the contention that the menhaden fishery would be adversely affected, 
FDA requested an EA from the petitioner. The decision to ask for an EA 
takes into consideration the agency's assessment of this issue as part 
of its previous action to affirm partially hydrogenated menhaden oil 
and hydrogenated menhaden oil as GRAS for use as edible fats or oils 
(54 FR 38219, September 15, 1989). The agency also has information 
indicating that the market for menhaden oil as a component of margarine 
is large, approximately 40 million pounds per year.
    Based on information in the petitioner's EA submitted for the 
current action and on the agency's analysis of the reports on the 
menhaden fisheries issued subsequent to FDA approval of GRAS petition 
(GRASP 6G0316 (54 FR 38219)), FDA concluded in the August 17, 1993, 
tentative final rule that the proposed action would not have a 
significant impact on the menhaden fishery. Amending the margarine 
standard of identity will not increase the volume of crude menhaden oil 
that is produced. The only change will be that crude menhaden oil will 
more often be retained in the United States for further processing into 
food grade products, instead of being shipped to Europe and elsewhere 
for this same use.
    Thus, FDA carefully considered the potential environmental effects 
of this action, including the effects on the menhaden fishery and 
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, which includes the petitioner's EA, 
the finding of no significant impact for FDA's approval of GRASP 6G0316 
(54 FR 38219), and a copy of ``National Marine Fisheries Service Final 
Purse-seine Landings of Gulf and Atlantic Menhaden in the 1990 and 1991 
Fishing Seasons'' have been placed on file in the Dockets Management 
Branch (HFA-305), Food and Drug Administration, rm. 1-23, 12420 
Parklawn Dr., Rockville, MD 20857, and may be seen by interested 
persons between 9 a.m. and 4 p.m., Monday through Friday.
    The agency has not received any additional information that would 
cause it to revise its finding of no significant impact on the human 
environment. Therefore, neither an environmental assessment nor an 
environmental impact statement is required.

List of Subjects in 21 CFR Part 166

    Food grades and standards, Food labeling, Margarine.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Food and Drugs, 21 CFR part 
166 is amended as follows:

PART 166--MARGARINE

    1. The authority citation for 21 CFR part 166 is revised to read as 
follows:

    Authority: Secs. 201, 401, 403, 407, 409, 701, 721 of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321, 341, 343, 347, 
348, 371, 379e).

    2. Section 166.110 is amended by adding new headings for the 
introductory text of paragraph (a) and paragraph (c), by revising 
paragraph (a)(1), and in the introductory text of paragraph (b) and 
paragraph (d) the headings ``Optional ingredients'' and ``Label 
declaration'', respectively, are italicized to read as follows:


Sec. 166.110  Margarine.

    (a) Description. * * *
    (1) Edible fats and/or oils, or mixtures of these, whose origin is 
vegetable or rendered animal carcass fats, or any form of oil from a 
marine species that has been affirmed as GRAS or listed as a food 
additive for this use, any or all of which may have been subjected to 
an accepted process of physico-chemical modification. They may contain 
small amounts of other lipids, such as phosphatides or unsaponifiable 
constituents, and of free fatty acids naturally present in the fat or 
oil.
* * * * *
    (b) Optional ingredients. * * *
* * * * *
    (c) Nomenclature. * * *
    (d) Label declaration. * * *

    Dated: May 16, 1994.
Michael R. Taylor,
Deputy Commissioner for Policy.
[FR Doc. 94-12804 Filed 5-24-94; 8:45 am]
BILLING CODE 4160-01-F