[Federal Register Volume 63, Number 101 (Wednesday, May 27, 1998)]
[Rules and Regulations]
[Pages 28893-28895]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-13917]


=======================================================================
-----------------------------------------------------------------------

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 Sec. 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 Sec. 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 (Sec. 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 (Sec. 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 
(Sec. 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\
---------------------------------------------------------------------------

    \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.
---------------------------------------------------------------------------

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

[[Page 28894]]

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 Sec. 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 Sec. 170.3(n)(9)

[[Page 28895]]

(21 CFR 170.3(n)(9)), coatings of soft candy as defined in 
Sec. 170.3(n)(38), and sweet sauces and toppings as defined in 
Sec. 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:


Sec. 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 Sec. 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 Sec. 170.3(n)(9) of this 
chapter, coatings of soft candy as defined in Sec. 170.3(n)(38) of this 
chapter, and sweet sauces and toppings as defined in Sec. 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