[Federal Register Volume 69, Number 100 (Monday, May 24, 2004)]
[Rules and Regulations]
[Pages 29428-29432]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-11502]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 172

[Docket No. 1999F-0719]


Food Additives Permitted for Direct Addition to Food for Human 
Consumption; Olestra

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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[[Page 29429]]

SUMMARY: The Food and Drug Administration (FDA) is amending the food 
additive regulations to allow for the safe use of olestra as a 
replacement for fats and oils in prepackaged, unpopped popcorn kernels 
that are ready-to-heat. This action is in response to a food additive 
petition (FAP) filed by the Procter and Gamble Co.

DATES: This rule is effective May 24, 2004; submit written or 
electronic objections and requests for a hearing by June 23, 2004. The 
Director of the Office of the Federal Register approves the 
incorporation by reference in accordance with 5 U.S.C. 552(a) and 1 CFR 
part 51 of certain publications in Sec.  172.867 (21 CFR 172.867) as of 
May 24, 2004.

ADDRESSES: Submit written objections to the Division of Dockets 
Management (HFA-305), Food and Drug Administration, rm. 1061, 5630 
Fishers Lane, Rockville, MD 20852. Submit electronic objections to 
http://www.fda.gov/dockets/ecomments.

FOR FURTHER INFORMATION CONTACT: Jason K. Dietz, Center for Food Safety 
and Applied Nutrition (HFS-255), Food and Drug Administration, 5100 
Paint Branch Pkwy., College Park, MD 20740-3835, 202-418-3299.

SUPPLEMENTARY INFORMATION:

Table of Contents

I. Subject of Petition
II. Background
III. Use of Olestra in Microwave Popcorn
    A. Effect on Estimated Consumption of Olestra
    B. Effect of Microwave Popcorn Preparation on Vitamins A, D, E, and 
K
    1. Temperatures Reached During Popcorn Preparation
    2. Degradation of Fat-Soluble Vitamins
    3. Safety of Fat-Soluble Vitamin Degradation Products
    4. Nutritional Implications of Fat-Soluble Vitamin Degradation
    C. Response to Comment
    D. Conclusions About the Use of Olestra in Microwave Popcorn
IV. Amendment of Sec.  172.867(b) and (c)
V. Deletion of Sec.  172.867(f)
VI. Summary
VII. Environmental Impact
VIII. Paperwork Reduction Act of 1995
IX. Inspection of Documents
X. Objections
XI. References

I. Subject of Petition

    In a notice published in the Federal Register of April 6, 1999 (64 
FR 16742), FDA announced that an FAP (FAP 9A4652) was filed by the 
Procter & Gamble Co., 6071 Center Hill Ave., Cincinnati, OH 45224 (P&G, 
the petitioner) proposing that the food additive regulations be amended 
in Sec.  172.867 Olestra to provide for the safe use of olestra in 
place of fats and oils in prepackaged, unpopped popcorn kernels that 
are ready-to-heat. In this document, such prepackaged popcorn kernels 
will be referred to as ``microwave popcorn.''\1\
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    \1\ Two basic types of prepackaged, unpopped popcorn kernels 
exist in the market: Popcorn kernels in microwavable bags with heat 
susceptors for heat transfer and popcorn kernels in aluminum foil 
packages for stovetop heating. Although the petitioned use includes 
retail products that would be heated on the stovetop as well as 
those heated in microwave ovens, for simplicity FDA refers to these 
products as ``microwave popcorn'' throughout this document.
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    Although not noted in the FAP (64 FR 16742), the petitioner also 
requested two editorial changes in the regulation that would have no 
effect on the substance of the regulation. Because the identity and 
specifications for olestra are now listed in the Food Chemicals Codex 
(FCC), the petitioner requested that the regulation incorporate by 
reference the specifications for olestra provided in the FCC, 
consistent with other regulations. The petitioner also requested that 
FDA update Sec.  172.867(f) because it is ``out-of-date.'' Section 
172.867(f) requires FDA to hold a Food Advisory Committee (FAC) meeting 
on olestra within 30 months of olestra's January 30, 1996, approval.

II. Background

    In the Federal Register of January 30, 1996 (61 FR 3118, ``the 1996 
final rule''), FDA announced the approval of olestra for use as a 
replacement for fats and oils in prepackaged ready-to-eat savory (i.e., 
salty or piquant but not sweet) snacks (Sec.  172.867). As part of the 
1996 final rule, FDA concluded that olestra inhibits the absorption of 
the fat-soluble components of the diet when these components are 
present in the gastrointestinal (GI) tract simultaneously with olestra 
(61 FR 3118 at 3132 to 3147). Such components include the fat-soluble 
vitamins A, D, E, and K. Based on data from nutritional studies 
conducted prior to the 1996 approval, FDA concluded that addition of 
the four fat-soluble vitamins (A, D, E, and K) to savory snacks 
containing olestra would compensate for any decreased absorption of 
these vitamins due to the action of olestra, thus ensuring that 
consumption of an olestra-containing savory snack would not alter the 
amount of vitamin available for absorption (61 FR 3118 at 3144 to 
3147). As part of its 1996 final rule approving the use of olestra in 
savory snacks, FDA required that specified amounts of vitamins A, D, E, 
and K be added to olestra-containing savory snacks (Sec.  172.867(d)).
    The 1996 final rule allowed the use of olestra in savory snacks 
that are ready-to-eat. Ready-to-eat savory snacks, including olestra-
containing ready-to-eat savory snacks and their added fat-soluble 
vitamins, do not require preparation (i.e., heat treatment) by the 
consumer prior to consumption. Therefore, in such olestra-containing 
savory snacks, the levels of added fat-soluble vitamins are unlikely to 
change between manufacturing and consumption by the consumer. In 
contrast, the current petition requests approval for a use of olestra 
in which the olestra-containing savory snack (microwave popcorn), 
including the added fat-soluble vitamins, must be heated by the 
consumer prior to consumption.\2\ This heat treatment may cause 
degradation of the added fat-soluble vitamins, resulting in the levels 
of fat-soluble vitamins present after heat preparation being less than 
those added by the manufacturer. This is not the case for ready-to-eat 
savory snacks which are not normally heated by consumers prior to 
consumption. Therefore, in ruling on this petition, FDA must consider 
whether heat preparation of olestra-containing microwave popcorn causes 
any nutritionally important effects in the levels of added fat-soluble 
vitamins. Additionally, FDA must consider whether any degradation 
products resulting from the heating of fat-soluble vitamins in olestra-
containing microwave popcorn raise any safety concerns.
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    \2\ In this case the product purchased by the consumer will be 
olestra mixed with unpopped popcorn kernels and vitamins A, D, E, 
and K in a container used to heat the unpopped popcorn kernels. 
Preparation of the kernels for consumption requires heating the 
kernels until they pop.
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III. Use of Olestra in Microwave Popcorn

A. Effect on Estimated Consumption of Olestra

    The use of olestra as a replacement for fats and oils in microwave 
popcorn will not change the estimated intake of olestra. In FDA's 1996 
decision, FDA calculated the estimated daily intake (EDI) of olestra 
based on the conservative assumption that all of the fat used in all 
savory snacks would be replaced by olestra. This approach to 
calculating the EDI included the assumption that all popcorn, 
regardless of source, would be made with olestra. Because the agency 
has already

[[Page 29430]]

included popcorn consumption from all sources in its estimate of 
olestra consumption, approval of the current petition would not change 
the EDI of olestra (Ref. 1).

B. Effect of Microwave Popcorn Preparation on Vitamins A, D, E, and K

    As noted, the current petition requests the approval of the use of 
olestra in a savory snack that will be heated by consumers prior to 
consumption. Heat treatment may cause degradation of vitamins, 
including those fat-soluble vitamins that would be added to olestra-
containing microwave popcorn. To address this concern, P&G studied the 
effect of heating on the degradation of fat-soluble vitamins A, D, E, 
and K.\3\ The petitioner chose to use microwave oven heating to study 
the thermal degradation of fat-soluble vitamins, asserting that: (1) 
Both stovetop-prepared and microwave oven-prepared products rely on 
lipids as a heat transfer medium to ``fry'' the kernels in either a 
foil package on a stovetop or in a bag in a microwave oven, (2) both 
the stovetop and microwave deliver similar amounts of heat during 
popcorn preparation, and (3) most consumers prepare popcorn at home in 
microwave ovens.
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    \3\ Safety issues associated with the heating of olestra have 
previously been considered (61 FR 3118 at 3130). The current 
petition presents no new issues regarding the heating of olestra.
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    FDA agrees that microwave heating of popcorn kernels is adequate to 
study the degradation of fat-soluble vitamins during heat preparation 
of both popcorn kernels in microwavable bags with heat susceptors and 
popcorn kernels in aluminum foil packages intended for stovetop heating 
(Ref. 1).
1. Temperatures Reached During Popcorn Preparation
    As part of its petition, P&G presents data about the temperatures 
reached during typical microwave heating of popcorn kernels by 
consumers.\4\ P&G demonstrates that the temperature inside bags of 
microwave popcorn increases from approximately 30 degrees Celsius at 
the start of heating to a maximum temperature of approximately 175 
degrees Celsius. The petitioner reported that exposure to temperatures 
of 150-175 degrees Celsius occurs for only a fraction (30-60 seconds) 
of a typical 3.5 minute popping cycle.\5\ For comparison, P&G points 
out that it is not uncommon to fry foods for 2 to 5 minutes at similar 
temperatures (150-200 degrees Celsius), including foods that serve as 
dietary sources of fat-soluble vitamins. Thus, fat-soluble vitamins 
added to microwave popcorn and heated in the home will not experience 
heating temperatures or times greater than those currently used in 
common food preparation practices.
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    \4\ P&G heated bags of microwave popcorn in a 1,000 Watt 
household microwave oven on high power until the popping frequency 
slowed to about 2-3 seconds between pops. Popping was usually 
``complete'' in about 3.5 minutes. The temperature inside the bag 
during popping was recorded every 15 seconds by four thermocouples 
inserted into the bag. After popping, the bags were opened within 30 
seconds after completion of popping and the popcorn transferred to a 
serving bowl, reflective of typical habit and practice for microwave 
popcorn consumers.
    \5\ FDA notes that data in the petition show that during typical 
microwave popcorn preparation temperatures greater than 150 degrees 
Celsius are achieved for approximately 90 seconds of the 3.5 minute 
popping cycle (Ref. 2).
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2. Degradation of Fat-Soluble Vitamins
    To assess the effect of microwave popcorn preparation on fat-
soluble vitamin degradation the petitioner analyzed samples from 
olestra-containing microwave popcorn prepared using a microwave oven. 
This analysis shows that 44 percent of vitamin A, 4.3 percent of 
vitamin D, and 24.4 percent of vitamin K are lost during microwave 
popcorn preparation.\6\
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    \6\ FDA notes that the scientific literature shows a vitamin A 
loss similar to that observed in the study conducted by P&G for 
microwave popcorn. In particular, vitamin A loss was reported to be 
40 percent in meat fried at 200 degrees Celsius for 5 minutes (Refs. 
2 and 3).
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    With respect to vitamin E, P&G states that loss of this vitamin was 
considered during FDA's review of the use of olestra in prepackaged, 
ready-to-eat savory snacks. Vitamin E loss was reported to be only 3-4 
percent (as a-tocopherol) under frying conditions (including time and 
temperature) that exceed those encountered during microwave popcorn 
preparation.\7\ Thus, vitamin E loss resulting from microwave popcorn 
preparation is unlikely to exceed 3-4 percent.
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    \7\ P&G determined the amount of vitamin E degraded during five 
deep fries each for 10 minutes at 375 degrees Farenheit (190 degrees 
Celsius), with wet filter paper and during shallow frying for 14 
minutes at 375 degrees Farenheit (190 degrees Celsius), with 
inclusion of a wet filter paper to simulate heat sink and hydrolysis 
conditions.
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3. Safety of Fat-Soluble Vitamin Degradation Products
    The petitioner considered the safety of degradation products 
resulting from the heating of fat-soluble vitamins. The petitioner 
stated that exposure to fat-soluble vitamin degradation products is not 
a new or unusual dietary experience because the chemical pathways 
producing fat-soluble vitamin degradation products in microwave popcorn 
and other heated foods are the same. Degradation products from vitamins 
A, D, E, and K are a natural consequence of cooking, and these 
degradation products are commonly eaten. P&G also states that the 
amount of fat-soluble vitamin degradation products in a serving of 
microwave popcorn is comparable to the amount found in servings of 
other fried/heated foods. P&G concludes that the exposure to fat-
soluble vitamin degradation products formed during the heating of 
microwave popcorn does not result in an increased safety risk relative 
to the exposure to degradation products arising from the frying of 
other foods commonly found in the diet. P&G states that microwave 
popcorn would just be another source of such degradation products.
    FDA considered that the exposure to fat-soluble vitamin degradation 
products from this use of olestra would be similar to, or less than, 
that from other foods fried in oils, or otherwise cooked (Ref. 1). 
Based on its safety review, FDA concludes that exposure to fat-soluble 
vitamin degradation products from this use of olestra would be safe 
(Ref. 2).
4. Nutritional Implications of Fat-Soluble Vitamin Degradation
    P&G states that the nutritional impact of fat-soluble vitamin 
degradation during microwave popcorn preparation can be assessed by 
examining the likelihood of these losses having a nutritionally 
significant effect on the overall vitamin status of microwave popcorn 
consumers. P&G asserts that a nutritionally significant impact on 
microwave popcorn consumers cannot occur if olestra's potential to 
interact with dietary sources of fat-soluble vitamins is limited or 
infrequent. The current petition includes data from the Snack Food 
Association's 1996 Consumer Snacking Behavior Report. These data 
demonstrate that microwave popcorn is eaten an average of two eating 
occasions in 14 days among popcorn eaters and is rarely eaten with 
meals. (Popcorn is eaten with only about 0.4 percent of all meals.) 
Microwave popcorn is consumed alone 45 percent of the time and rarely 
with other foods that are significant sources of fat-soluble vitamins. 
When other foods are consumed with microwave popcorn, a beverage is the 
preferred choice (42 percent of popcorn eating occasions). Based on 
these data, P&G asserts that there is little potential for the use of 
olestra in microwave popcorn to have an effect on the fat-soluble 
vitamin status of microwave popcorn consumers. Therefore, the 
petitioner concluded that the levels of vitamins A, D, E, and K 
currently required to be

[[Page 29431]]

added to olestra-containing savory snacks under Sec.  172.867(d) are 
sufficient for addition to microwave popcorn.
    FDA agrees with the petitioner that the levels of vitamins A, D, E, 
and K required to be added to microwave popcorn should be those 
specified in Sec.  172.867(d). FDA reached this conclusion because 
olestra-containing microwave popcorn is not likely to be consumed 
concurrently with dietary sources of fat-soluble vitamins. Therefore, 
it is unlikely that a person's daily intake of fat-soluble vitamins 
would be affected by the consumption of microwave popcorn that contains 
olestra. Moreover, the levels of vitamins D and E that are degraded 
during the heating process amount to such a small quantity 
(approximately 4 percent) that the systemic levels of these vitamins 
would not be affected by the small amounts degraded (Ref. 2).

C. Response to Comment

    Although section 409 of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 348) establishes no comment period for FAPs, and the agency 
generally does not solicit comments in notices announcing the filing of 
an FAP, it is FDA's practice to consider any relevant comments timely 
submitted. FDA received one comment on the use of olestra in microwave 
popcorn. The comment and the agency's response follow.
    A comment from an individual consumer requested that FDA deny the 
current petition. The comment expressed concern about the amount of 
iron added to foods and the potential effects on infants of excess 
folic acid in their mother's diet. The comment states that the public 
does not know about the amounts of excess vitamins and iron added to 
their diets. The comment also requested that FDA allow each individual 
to add their own vitamins as needed.
    The regulation that is the subject of this petition does not 
require that either iron or folic acid be added to olestra-containing 
products. Thus, issues surrounding excess levels of these nutrients in 
the diet are outside the scope of this petition.

D. Conclusions About the Use of Olestra in Microwave Popcorn

    Based on a fair evaluation of the data and information in the 
current FAP, as well as data and information in the original FAP (FAP 
7A3997) that resulted in the establishment of Sec.  172.867, FDA has 
concluded that there is a reasonable certainty that no harm will result 
from the use of olestra as a replacement for fats and oils in microwave 
popcorn. FDA is requiring that vitamins A, D, E, and K be added to 
microwave popcorn at levels specified in Sec.  172.867(d).

IV. Amendment of Sec.  172.867(b) and (c)

    In its petition, P&G requested that Sec.  172.867(b), which 
contains specifications for food-grade olestra, be amended to reference 
the specifications for food-grade olestra set forth in the FCC, fourth 
edition, first supplement. P&G observes that the specifications set out 
in the FCC monograph for olestra are identical to those currently 
provided in Sec.  172.867(b) (Ref. 1).
    In establishing food additive approval regulations, FDA generally 
incorporates by reference FCC specifications where such specifications 
have been issued and are consistent with FDA's safety evaluation. As 
noted, the FCC specifications are the same as those issued by FDA and 
thus, this change is simply editorial. In addition, manufacturers 
generally look to the FCC for food grade specifications. Accordingly, 
FDA agrees that current Sec.  172.867(b) should be amended to remove 
the current specifications in this paragraph and in their place to 
incorporate by reference the FCC specifications for food-grade olestra. 
FDA has concluded that the use of olestra as a replacement for fats and 
oils in microwave popcorn is safe. Accordingly, the agency is amending 
Sec.  172.867(c) to include this use of the additive.

V. Deletion of Sec.  172.867(f)

    In its petition, P&G also noted that Sec.  172.867(f) is obsolete. 
In the 1996 final rule, FDA committed to review and evaluate all data 
and information bearing on the safety of olestra received by the agency 
after the effective date of the regulation (January 30, 1996) and 
present such data, information, and evaluation to the agency's Food 
Advisory Committee (FAC) within 30 months of the approval of olestra 
(61 FR 3118 at 3168-3169; Sec.  172.867(f)). Consistent with its 
obligation under Sec.  172.867(f), FDA convened a meeting of its FAC on 
June 15-17, 1998, fulfilling its obligation under Sec.  172.867(f).\8\ 
Thus, FDA has concluded that Sec.  172.867(f) no longer serves a 
function and should be deleted.
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    \8\ At an open public meeting, held June 15-17, 1998, new data 
and information concerning olestra, obtained since the 1996 approval 
were presented. The complete set of transcripts of the June 15-17, 
1998, FAC meeting is publicly available through FDA's Division of 
Dockets Management and through FDA's Internet site. The Internet 
site is located at http://www.fda.gov/ohrms/dockets/ac/
cfsan98t.htm[numsign]Food Advisory Committee (choose June 15, 16, 
and 17).
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VI. Summary

    FDA has concluded that there is reasonable certainty that no harm 
will result from the use of olestra in microwave popcorn (21 CFR 
170.3(i)). FDA is requiring that vitamins A, D, E, and K be added to 
microwave popcorn at levels currently specified in Sec.  172.867(d). 
FDA has also concluded that Sec.  172.867 should be updated by revising 
Sec.  172.867(b) to incorporate by reference the food-grade 
specifications for olestra set forth in the FCC, fourth edition, first 
supplement and by deleting Sec.  172.867(f).

VII. Environmental Impact

    The agency has carefully considered the potential environmental 
effects of this action. FDA has 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, 
contained in an environmental assessment, may be seen in the Division 
of Dockets Management (see ADDRESSES) between 9 a.m. and 4 p.m., Monday 
through Friday.

VIII. Paperwork Reduction Act of 1995

    This final rule contains no collection of information. Therefore, 
clearance by the Office of Management and Budget under the Paperwork 
Reduction Act of 1995 is not required.

IX. Inspection of Documents

    In accordance with Sec.  171.1(h) (21 CFR 171.1(h)), the petition 
and the documents that FDA considered and relied upon in reaching its 
decision to approve the petition are available for inspection at the 
Center for Food Safety and Applied Nutrition (see ADDRESSES) by 
appointment with the information contact person (see FOR FURTHER 
INFORMATION CONTACT). As provided in Sec.  171.1(h), the agency will 
delete from the documents any materials that are not available for 
public disclosure before making the documents available for inspection.

X. Objections

    Any person who will be adversely affected by this regulation may 
file with the Division of Dockets Management (see ADDRESSES) written or 
electronic objections (see DATES). Each objection shall be separately 
numbered, and each numbered objection shall specify with particularity 
the provisions of the regulation to which objection is made and the 
grounds for the objection. Each numbered objection on which a hearing 
is requested shall specifically so state. Failure to request a hearing 
for any

[[Page 29432]]

particular objection shall constitute a waiver of the right to a 
hearing on that objection. Each numbered objection for which a hearing 
is requested shall include a detailed description and analysis of the 
specific factual information intended to be presented in support of the 
objection in the event that a hearing is held. Failure to include such 
a description and analysis for any particular objection shall 
constitute a waiver of the right to a hearing on the objection. Three 
copies of all documents shall be submitted and shall be identified with 
the docket number found in brackets in the heading of this document. 
Any objections received in response to the regulation may be seen in 
the Division of Dockets Management between 9 a.m. and 4 p.m., Monday 
through Friday.

XI. References

    The following references have been placed on display in the 
Division of Dockets Management and may be seen by interested persons 
between 9 a.m. and 4 p.m., Monday through Friday.
    1. Memorandum from M. DiNovi, FDA to M. Ditto, FDA, August 10, 
1999.
    2. Memorandum from T. P. Twaroski, FDA to M. Ditto, FDA, May 17, 
2002.
    3. Burger, I. H. and Walters, C. L., ``The Effect of Processing 
on the Nutritive Value of Flesh Foods,'' Proceedings of the 
Nutrition Society, 32:1-8, 1973.
    4. Memorandum from M. DiNovi, FDA to M. Ditto, FDA, May 6, 2002.

List of Subjects in 21 CFR Part 172

    Food additives, Incorporation by reference, Reporting and 
recordkeeping requirements.

0
Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Food and Drugs, 21 CFR part 
172 is amended as follows:

PART 172--FOOD ADDITIVES PERMITTED FOR DIRECT ADDITION TO FOOD FOR 
HUMAN CONSUMPTION

0
1. The authority citation for 21 CFR part 172 continues to read as 
follows:

    Authority: 21 U.S.C. 321, 341, 342, 348, 371, 379e.


0
2. Section 172.867 is amended by revising paragraphs (b) and (c) and by 
removing paragraph (f) to read as follows:


Sec.  172.867  Olestra.

* * * * *
    (b) Olestra meets the specifications of the Food Chemicals Codex, 
4th edition, 1st supplement (1997), pp. 33-35, which is incorporated by 
reference. The Director of the Office of the Federal Register approves 
this incorporation by reference in accordance with 5 U.S.C. 552(a) and 
1 CFR part 51. You may obtain copies from the National Academy Press, 
2101 Constitution Ave. NW., Washington, DC 20418 (Internet address 
http://www.nap.edu). Copies may be examined at the Center for Food 
Safety and Applied Nutrition's Library, Food and Drug Administration, 
5100 Paint Branch Pkwy., College Park, MD 20740, or at the National 
Archives and Records Administration (NARA). For information on the 
availability of this material at NARA, call 202-741-6030, or go to: 
http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.
    (c) Olestra may be used in place of fats and oils in prepackaged 
ready-to-eat savory (i.e., salty or piquant but not sweet) snacks and 
prepackaged, unpopped popcorn kernels that are ready-to-heat. In such 
foods, the additive may be used in place of fats and oils for frying or 
baking, in dough conditioners, in sprays, in filling ingredients, or in 
flavors.
* * * * *

    Dated: May 12, 2004.
William K. Hubbard,
Associate Commissioner for Policy and Planning.
[FR Doc. 04-11502 Filed 5-21-04; 8:45 am]
BILLING CODE 4160-01-S