Federal Register / Vol. 63, No. 101 /Wednesday, May 27, 1998 /Rules and Regulations 28893

1 In a comment submitted to the agency, Loders

Croklaan, Inc., also requested that all safety data

and other information concerning sheanut oil

contained in its Food Master File (FMF) No. 253 be

incorporated into Fuji’s petition. Consequently, the

information contained in FMF No. 253 was made

available for public display under the same docket

no. 88G–0288 with the Fuji petition.

2 In addition, in its comment Loders Croklaan,

Inc., quoted official United Kingdom statistics for

sheanuts imported into the United Kingdom as

averaging 6,000 metric tons per year between 1948

and 1957.

airspace within the Knoxville, IA, Class E

airspace area.

* * * * *

Issued in Kansas City, MO, on March 31,

1998.

Christopher R. Blum,

Acting Manager, Air Traffic Division, Central

Region.

[FR Doc. 98–13995 Filed 5–26–98; 8:45 am]

BILLING CODE 13–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Part 184

[Docket No. 88G–0288]

Direct Food Substances Affirmed As

Generally Recognized as Safe;

Sheanut Oil

AGENCY: Food and Drug Administration,

HHS.

ACTION: Final rule.

SUMMARY: The Food and Drug

Administration (FDA) is amending its

regulations to affirm that the use of

sheanut oil as a direct human food

ingredient is generally recognized as

safe (GRAS). This action is in response

to a petition filed by Fuji Oil Co., Ltd.

DATES: The regulation is effective May

27, 1998.

FOR FURTHER INFORMATION CONTACT:

William J. Trotter, Center for Food

Safety and Applied Nutrition (HFS–

206), Food and Drug Administration,

200 C St. SW., Washington, DC 20204,

202–418–3088.

SUPPLEMENTARY INFORMATION:

I. Background

In accordance with the procedures

described in § 170.35 (21 CFR 170.35),

Fuji Oil Co., Ltd., 6–1, Hachiman-Cho,

Minami-Ku, Osaka 542, Japan,

submitted a petition (GRASP 8G0343)

requesting that sheanut oil be affirmed

as GRAS for use as a direct food

ingredient.

FDA published a notice of filing of

this petition in the Federal Register of

September 30, 1988 (53 FR 38347), and

gave interested parties an opportunity to

submit comments to the agency. FDA

received three comments in response to

that notice. These comments are

discussed in section VIII of this

document.

II. Standards for GRAS Affirmation

Under § 170.30 (21 CFR 170.30),

general recognition of safety may be

based only on the views of experts

qualified by scientific training and

experience to evaluate the safety of

substances. The basis of such views may

be either: (1) Scientific procedures, or

(2) in the case of a substance used in

food prior to January 1, 1958, through

experience based on common use in

food (§ 170.30(a)). General recognition

of safety based upon scientific

procedures requires the same quantity

and quality of scientific evidence as is

required to obtain approval of a food

additive and ordinarily is to be based

upon published studies, which may be

corroborated by unpublished studies

and other data and information

(§ 170.30(b)). General recognition of

safety through experience based on

common use in food prior to January 1,

1958, may be determined without the

quantity or quality of scientific

procedures required for approval of a

food additive, but ordinarily is to be

based upon generally available data and

information concerning the pre-1958

history of use of the food ingredient

(§ 170.30(c)(1)). In evaluating this

petition, the agency reviewed

information and data on the history of

sheanut oil use and on published and

unpublished safety studies for sheanut

oil.

III. Identity and Specification

Sheanut oil is produced from

sheanuts derived from the Shea tree

Butyrospermum parkii and is composed

mainly of triglycerides containing an

oleic acid moiety at the 2-position and

saturated fatty acids, usually stearic or

palmitic acids, at the 1- and 3-positions.

It meets the following specifications,

which are consistent with those for

other food-grade oils as described in the

Food Chemicals Codex (Ref. 1):

1. Saponification value—185 to 195,

2. Iodine value—28 to 43,

3. Unsaponifiable matter—not to

exceed 1.5 percent,

4. Free fatty acids—less than 0.1

percent (as oleic acid),

5. Peroxide value—less than 10

milliequivalents/equivalent (meq/eq),

6. Heavy metals—less than 0.1 part

per million (ppm) each of lead and

copper.

The petitioner adequately referenced

methods of analyses for these

specifications.

IV. Manufacturing Process

Sheanut oil is refined by various

processes, which may involve different

sequences of manufacturing steps and

solvents that are in common use in the

fat and oil industry. The crude oil must

be refined to remove excessive

unsaponifiable material. Standard

refining techniques, e.g., decolorization

by passage through bleaching clay and

steam distillation to remove odoriferous

impurities, are employed to purify

further the oil.

V. Proposed Use in Food

The intended use for sheanut oil is as

a component of a mixture of oils used

as cocoa butter substitutes. The agency

has calculated a mean estimated daily

intake (EDI) of 2.2 gram/person/day (g/

p/d) for sheanut oil in confections and

candies (2+ year olds). The EDI for

consumers at the 90th percentile level is

4.4 g/p/d. The EDI for children from 2

to 5 years old is 1.8 g/p/d at the mean

and 4.3 g/p/d at the 90th percentile

level.

VI. Common Use in Food Before 1958

The petitioner provided several

published articles that document that

sheanut oil has a history of common use

in food prior to 1958. Sheanut oil has

been used in Africa for food purposes

since the 1800’s (Ref. 2). It has also been

used in Europe as a cooking oil and as

a cocoa butter substitute, as well as for

making margarine (Ref. 3 through 7). In

addition, in a comment submitted in

support of the petition, Loders Croklaan,

Inc.,1 of Berwyn, PA, presented

information that documents use of

sheanut oil in England for more than 50

years; among the uses of sheanut oil

documented in this comment were as a

pastry fat, a cooking oil, a cocoa butter

substitute, and for making margarine.

The comment provided copies of

formulations from England that showed

that some cooking fats in 1948

contained between 5 and 7 percent

sheanut oil and that a pastry margarine

known as ‘‘flex,’’ marketed between

1954 and 1958, contained between 80

and 91 percent sheanut oil. 2

VII. Safety Information

The evidence documenting common

use of sheanut oil in food reflects no

known adverse effects. The absence of

documented adverse effects from food

use of sheanut oil is corroborated by

several animal feeding studies, by

information regarding the components

of sheanut oil, and its similarity in
28894 Federal Register / Vol. 63, No. 101 /Wednesday, May 27, 1998 /Rules and Regulations

composition to other GRAS fats and

oils.

Specifically, sheanut oil is composed

principally of triglycerides containing

oleic acid in the 2-position and the

saturated fatty acids, usually stearic and

palmitic acids, in the 1- and 3-positions.

The components of these triglycerides,

glycerol, and oleic, stearic, and palmitic

acids, as well as other fatty acids found

as minor components, are naturally

found as part of lipids and lipoproteins

of both plants and animals; they are also

the same fatty acids and glycerol

components found in a broad range of

edible fats and oils that are GRAS. The

synthesis and metabolism of these

substances are well understood and are

documented in biochemistry textbooks

(for example, Ref. 8).

In addition, the agency has

determined that sheanut oil has an

overall composition that conforms to

that of other edible oils in terms of its

total glyceride content, fractions of tri-

, di- and monoglycerides, and

unsaponifiable matter (Ref. 9). Thus,

sheanut oil is similar in chemical

composition to commonly used GRAS

fats and oils, such as cocoa butter,

cottonseed oil, soybean oil, corn oil, and

palm oil.

Further, the agency evaluated four

corroborative animal studies on the

safety of sheanut oil. Three of these

studies, which are published (Ref. 10

through 12), establish that sheanut oil

has absorbability comparable to that as

the other tested GRAS oils and fats.

These studies also establish that the

growth rates for the subject animals

were comparable to those for animals

fed other GRAS oils and fats. The fourth

study, which is unpublished, is a 104-

week toxicity/carcinogenicity study of

sheanut oil and other oils in rats. The

results of this 104-week study

demonstrate that there is no

carcinogenic potential for sheanut oil

(Ref. 13).

VIII. Response to Comments

In response to the published notice,

FDA received three comments from the

law offices of Freeman, Wasserman &

Schneider on behalf of Loders Croklaan,

Inc., of Berwyn, PA.

As discussed previously, the first

comment requested that FDA

incorporate the safety data and other

information on sheanut oil submitted by

Loders Croklaan, Inc., and contained in

FMF No. 253. The comment asserted

that, in addition to the fact that sheanut

oil has been used as part of the human

diet for a considerable period of time

prior to 1958 in countries outside the

United States, the safety data also

establish that sheanut oil is safe for

human consumption.

The second comment, also submitted

in support of the petition, was intended

to: (1) Provide independent

documentation of the history of use of

sheanut oil in food prior to 1958

(discussed in section VI of this

document), (2) provide safety data for

sheanut oil (discussed in section VII of

this document), and (3) suggest

modifications to the proposed

specifications of sheanut oil. These

suggested modifications are consistent

with the fact that sheanut oil can be

made by different processes that involve

various sequences of processing steps

and various solvents. The comment

asserted that certain changes, discussed

as follows, should be made to the

specifications proposed by the

petitioner.

First, the comment stated that the

refined oil produced by Loders

Croklaan, Inc.’s process, which has an

iodine value typically between 33 and

43, allows for a greater percentage of 2-

oleoyl-1,3-distearin (SOS). The

comment pointed out that an oil

composed entirely of SOS would have

an iodine value of 25 and, therefore,

recommended a specification for an

iodine value between 25 and 43.

Second, the comment stated that, if a

specification for residual solvent is

included, it should reflect the possible

varieties of recrystallizing and

precipitating solvents typically used in

the fat and oil industry, instead of

specifications for hexane and ethanol

only, which the petitioner uses in its

process. Third, the comment stated that

the proposed specifications for specific

gravity and refractive index reflect only

the petitioner’s oil product and that if

these specifications are to be included

in a regulation, the comment suggested

that broader ranges be used to reflect

industry-wide standards rather than the

petitioner’s specific product.

The agency agrees that sheanut oil

may be refined using a variety of

solvents and procedures commonly

used in the fats and oils industry. The

agency believes that sheanut oil

produced by standard processing of

sheanuts, including further refining to

remove excessive unsaponifiable

material, should be the food ingredient

to be affirmed as GRAS and that the

specifications for sheanut oil should

encompass all of the typical sheanut oils

produced under good manufacturing

practices.

The agency agrees with the comment

that the range given for iodine value

should be modified. However, the

agency has calculated a theoretical

iodine value for pure SOS of 28.6 and,

therefore, believes that a specification

range of 28 to 43 would encompass all

likely refined sheanut oils (Ref. 14).

With regard to residual solvents, the

agency agrees with the comment that

the specifications for solvents should

not be limited to those used by the

petitioner (Ref. 14). The agency notes

that solvents other than those used by

the petitioner are used in the fats and

oils industry, and further notes that any

residual solvent that becomes or may

reasonably be expected to become a

functional component of sheanut oil

must be GRAS or a food additive

approved for use in the manufacture of

food fats and oils. Therefore, the agency

believes that no specification for

solvents is necessary. Similarly, the

agency does not believe that

specifications for specific gravity and

refractive index are necessary in a

regulation in order to ensure a safe

product; this would be consistent with

specifications for other food-grade oils

as described in the Food Chemicals

Codex (Ref. 1).

The third comment was a reiteration

of Loders Croklaan, Inc.’s position

regarding specifications for sheanut oil,

which have been discussed previously,

together with the agency’s response.

IX. Conclusions

The petitioner has provided evidence

that demonstrates that sheanut oil was

in common use in food prior to 1958;

this information is published and is

corroborated by other information from

separate published sources, including

information submitted in a comment.

There are no reports of adverse effects

from such food use of sheanut oil. As

provided for under § 170.30(a)(2), FDA

has determined that this information

provides an adequate basis upon which

to conclude that the use of sheanut oil

is GRAS among experts qualified by

scientific training and experience to

evaluate the safety of substances used in

food.

This evidence of common use in food

prior to 1958 without any reported

adverse effects is further corroborated

by information regarding the

components of sheanut oil, the

similarity of sheanut oil to other oils

that are GRAS, and the results of four

animal feeding studies, three of which

are published. Therefore, the agency is

affirming the use of sheanut oil as GRAS

in accordance with 21 CFR 184.1(b)(3)

in the following food categories at levels

not to exceed current good

manufacturing practice, except that the

ingredient may not be used in a

standardized food unless permitted by

the standard of identity: Confections

and frostings as defined in § 170.3(n)(9)
Federal Register / Vol. 63, No. 101 /Wednesday, May 27, 1998 /Rules and Regulations 28895

(21 CFR 170.3(n)(9)), coatings of soft

candy as defined in § 170.3(n)(38), and

sweet sauces and toppings as defined in

§ 170.3(n)(43).

X. Environmental Effects

The agency has determined under 21

CFR 25.32(f) that this action is of a type

that does not individually or

cumulatively have a significant effect on

the human environment. Therefore,

neither an environmental assessment

nor an environmental impact statement

is required.

XI. Analysis of Impacts

FDA has examined the impacts of the

final rule under Executive Order 12866

and the Regulatory Flexibility Act (5

U.S.C. 601–612). 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). According to

Executive Order 12866, a regulatory

action is ‘‘economically significant’’ if it

meets any one of a number of specified

conditions, including having an annual

effect on the economy of $100 million

or adversely affecting in a material way

a sector of the economy, competition, or

jobs. A regulation is considered

‘‘significant’’ under Executive Order

12866 if it raises novel legal or policy

issues. The agency finds that this rule is

neither an economically significant nor

a significant regulatory action as defined

by Executive Order 12866. In addition,

it has been determined that this final

rule is not a major rule for the purpose

of congressional review.

The primary benefit of this action is

to remove uncertainty about the

regulatory status of the petitioned

substance. No compliance costs are

associated with this final rule because

no new activity is required, and no

current or future activity is prohibited

by this rule.

The Regulatory Flexibility Act

requires agencies to analyze regulatory

options that would minimize the

economic impact of their regulations on

small businesses and other small

entities. No compliance costs are

associated with this final rule because

no new activity is required, and no

current or future activity is prohibited.

Therefore, this final rule will not have

a significant economic impact on a

substantial number of small entities.

Accordingly, under the Regulatory

Flexibility Act, the agency certifies that

this final rule will not have a significant

economic impact on a substantial

number of small entities.

XII. Effective Date

This rule recognizes an exemption

from the food additive definition in the

Federal Food, Drug, and Cosmetic Act,

and from the approval requirements

applicable to food additives. Thus, no

delay in the effective date is required by

the Administrative Procedure Act (5

U.S.C. 553(d)). Therefore, the rule will

be effective immediately (5 U.S.C.

553(d)(1)).

XIII. References

The following references have been

placed on display in the Dockets

Management Branch (address above)

and may be seen by interested persons

between 9 a.m. and 4 p.m., Monday

through Friday.

1. Food Chemicals Codex, National

Research Council, National Academy

Press, Washington, DC, 4th ed., 1996.

2. ‘‘Shea,’’ The Oxford English

Dictionary, The Clarendon Press,

Oxford, p. 648, 1933.

3. Hefter, G., Technologie der Fette

und Ole, Julius Springer, Berlin, pp.

688–693, 1908.

4. Jamieson, G. S., Vegetable Fats and

Oils, Reinhold Publishing Corp., New

York, p. 63, 1943.

5. Schwitzer, M. K., Margarine and

Other Food Fats, Leonard Hill [Books],

Ltd., London, p. 40, 1956.

6. Commonwealth Economic

Committee, Vegetables Oils and

Oilseeds, Royal Stationary Office,

London, pp. 130–131, 1952.

7. Anderson, J. A. C., and P. N.

Williams, Margarine, Pergamon Press,

Oxford, 2d revised ed., p. 34, 1965.

8. Lehninger, A. L., Principles of

Biochemistry, Worth Publishers, Inc.,

New York, NY, 1982.

9. Memorandum from M. DiNovi,

FDA to L. Lin, FDA, January 9, 1989.

10. Thomasson, H. J., ‘‘The Biological

Value of Oils and Fats: I. Growth and

Food Intake on Feeding with Natural

Oils and Fats,’’ Journal of Nutrition 56,

pp. 455–468, 1955.

11. Thomasson, H. J., ‘‘The Biological

Value of Oils and Fats: IV. The Rate of

Intestinal Absorption,’’ Journal of

Nutrition 59, pp. 343–352, 1956.

12. Sawadogo, K. A., and J. A. Bezard,

‘‘Triglyceride Structure of Adipose

Tissue of Rats Fed a Diet Based on Shea

Butter,’’ Oleagineux 37, pp. 247–253,

1982.

13. Memorandum of C. Johnson, FDA

to K. Ekelman, FDA, May 18, 1995.

14. Memorandum of M. DiNovi, FDA

to L. Lin, FDA, February 21, 1989.

List of Subjects in 21 CFR Part 184

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, 21 CFR part 184 is

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 184.1702 is added to read

as follows:

§ 184.1702 Sheanut oil.

(a) Sheanut oil is produced from

sheanuts derived from the Shea tree

Butyrospermum parkii and is composed

principally of triglycerides containing

an oleic acid moiety at the 2-position

and saturated fatty acids, usually stearic

or palmitic acids, at the 1- and 3-

positions.

(b) The ingredient meets the following

specifications when tested using any

appropriate validated methodology:

(1) Saponification value of 185 to 195,

(2) Iodine value of 28 to 43,

(3) Unsaponifiable matter not to

exceed 1.5 percent,

(4) Free fatty acids not more than 0.1

percent as oleic acid,

(5) Peroxide value not more than 10

milliequivalents/equivalent (meq/eq),

(6) Lead not more than 0.1 part per

million (ppm),

(7) Copper not more than 0.1 ppm.

(c) In accordance with § 184.1(b)(3),

the ingredient is used in the following

food categories at levels not to exceed

current good manufacturing practice,

except that the ingredient may not be

used in a standardized food unless

permitted by the standard of identity:

Confections and frostings as defined in

§ 170.3(n)(9) of this chapter, coatings of

soft candy as defined in § 170.3(n)(38) of

this chapter, and sweet sauces and

toppings as defined in § 170.3(n)(43) of

this chapter.

Dated: May 13, 1998.

L. Robert Lake,

Director, Office of Policy, Planning and

Strategic Initiatives, Center for Food Safety

and Applied Nutrition.

[FR Doc. 98–13917 Filed 5–26–98; 8:45 am]

BILLING CODE 4160–01–F