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

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