[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published studies, which may be corroborated by unpublished studies and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
