[Federal Register Volume 67, Number 220 (Thursday, November 14, 2002)]
[Notices]
[Pages 69003-69009]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-28909]


-----------------------------------------------------------------------

ENVIRONMENTAL PROTECTION AGENCY

[OPP-2002-0294; FRL-7279-3]


Alpha-cyclodextrin, Beta-cyclodextrin, and Gamma-cyclodextrin; 
Notice of Filing a Pesticide Petition to Establish an Exemption from 
the Requirement of a Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: This notice announces the initial filing of a pesticide 
petition proposing the establishment of regulations for residues of 
alpha-cyclodextrin, beta-cyclodextrin, and gamma-cyclodextrin in or on 
various food commodities.

DATES: Comments, identified by docket ID number OPP-2002-0294, must be 
received on or before December 16, 2002.

ADDRESSES: Comments may be submitted electronically, by mail, or 
through hand delivery/courier. Follow the detailed instructions as 
provided in Unit I. of the SUPPLEMENTARY INFORMATION.

FOR FURTHER INFORMATION CONTACT: Treva Alston, Minor Use, Inerts, and 
Emergency Reponse Branch, Registration Division (7505W), Office of 
Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania 
Ave., NW., Washington, DC 20460-0001; telephone number: (703) 308-8373; 
e-mail address: [email protected].

[[Page 69004]]


SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

     You may be potentially affected by this action if you are an 
agricultural producer, food manufacturer, or pesticide manufacturer. 
Potentially affected entities may include, but are not limited to:
    [sbull] Crop production (NAICS code 111)
    [sbull] Animal production (NAICS code 112)
    [sbull] Food manufacturing (NAICS code 311)
    [sbull] Pesticide manufacturing (NAICS code 32532)
     This listing is not intended to be exhaustive, but rather provides 
a guide for readers regarding entities likely to be affected by this 
action. Other types of entities not listed in this unit could also be 
affected. The North American Industrial Classification System (NAICS) 
codes have been provided to assist you and others in determining 
whether this action might apply to certain entities. If you have any 
questions regarding the applicability of this action to a particular 
entity, consult the person listed under FOR FURTHER INFORMATION 
CONTACT.

B. How Can I Get Copies of this Document and Other Related Information?

    1. Docket. EPA has established an official public docket for this 
action under docket ID number OPP-2002-0294. The official public docket 
consists of the documents specifically referenced in this action, any 
public comments received, and other information related to this action. 
Although, a part of the official docket, the public docket does not 
include Confidential Business Information (CBI) or other information 
whose disclosure is restricted by statute. The official public docket 
is the collection of materials that is available for public viewing at 
the Public Information and Records Integrity Branch (PIRIB), Rm. 119, 
Crystal Mall 2, 1921 Jefferson Davis Hwy., Arlington, VA. This 
docket facility is open from 8:30 a.m. to 4 p.m., Monday through 
Friday, excluding legal holidays. The docket telephone number is (703) 
305-5805.
    2. Electronic access. You may access this Federal Register document 
electronically through the EPA internet under the ``Federal Register'' 
listings at http://www.epa.gov/fedrgstr/.
     An electronic version of the public docket is available through 
EPA's electronic public docket and comment system, EPA dockets. You may 
use EPA dockets at http://www.epa.gov/edocket/ to submit or view public 
comments, access the index listing of the contents of the official 
public docket, and to access those documents in the public docket that 
are available electronically. Although, not all docket materials may be 
available electronically, you may still access any of the publicly 
available docket materials through the docket facility identified in 
Unit I.B.1. Once in the system, select ``search,'' then key in the 
appropriate docket ID number.
     Certain types of information will not be placed in the EPA 
dockets. Information claimed as CBI and other information whose 
disclosure is restricted by statute, which is not included in the 
official public docket, will not be available for public viewing in 
EPA's electronic public docket. EPA's policy is that copyrighted 
material will not be placed in EPA's electronic public docket but will 
be available only in printed, paper form in the official public docket. 
To the extent feasible, publicly available docket materials will be 
made available in EPA's electronic public docket. When a document is 
selected from the index list in EPA dockets, the system will identify 
whether the document is available for viewing in EPA's electronic 
public docket. Although, not all docket materials may be available 
electronically, you may still access any of the publicly available 
docket materials through the docket facility identified in Unit I.B. 
EPA intends to work towards providing electronic access to all of the 
publicly available docket materials through EPA's electronic public 
docket.
     For public commenters, it is important to note that EPA's policy 
is that public comments, whether submitted electronically or in paper, 
will be made available for public viewing in EPA's electronic public 
docket as EPA receives them and without change, unless the comment 
contains copyrighted material, CBI, or other information whose 
disclosure is restricted by statute. When EPA identifies a comment 
containing copyrighted material, EPA will provide a reference to that 
material in the version of the comment that is placed in EPA's 
electronic public docket. The entire printed comment, including the 
copyrighted material, will be available in the public docket.
     Public comments submitted on computer disks that are mailed or 
delivered to the docket will be transferred to EPA's electronic public 
docket. Public comments that are mailed or delivered to the docket will 
be scanned and placed in EPA's electronic public docket. Where 
practical, physical objects will be photographed, and the photograph 
will be placed in EPA's electronic public docket along with a brief 
description written by the docket staff.

C. How and To Whom Do I Submit Comments?

     You may submit comments electronically, by mail, or through hand 
delivery/courier. To ensure proper receipt by EPA, identify the 
appropriate docket ID number in the subject line on the first page of 
your comment. Please ensure that your comments are submitted within the 
specified comment period. Comments received after the close of the 
comment period will be marked ``late.'' EPA is not required to consider 
these late comments. If you wish to submit CBI or information that is 
otherwise protected by statute, please follow the instructions in Unit 
I.D. Do not use EPA dockets or e-mail to submit CBI or information 
protected by statute.
    1. Electronically. If you submit an electronic comment as 
prescribed in this unit, EPA recommends that you include your name, 
mailing address, and an e-mail address or other contact information in 
the body of your comment. Also include this contact information on the 
outside of any disk or CD ROM you submit, and in any cover letter 
accompanying the disk or CD ROM. This ensures that you can be 
identified as the submitter of the comment and allows EPA to contact 
you in case EPA cannot read your comment due to technical difficulties 
or needs further information on the substance of your comment. EPA's 
policy is that EPA will not edit your comment, and any identifying or 
contact information provided in the body of a comment will be included 
as part of the comment that is placed in the official public docket, 
and made available in EPA's electronic public docket. If EPA cannot 
read your comment due to technical difficulties and cannot contact you 
for clarification, EPA may not be able to consider your comment.
    i. EPA Dockets. Your use of EPA's electronic public docket to 
submit comments to EPA electronically is EPA's preferred method for 
receiving comments. Go directly to EPA dockets at http://www.epa.gov/edocket, and follow the online instructions for submitting comments. 
Once in the system, select ``search,'' and then key in docket ID number 
OPP-2002-0294. The system is an ``anonymous access'' system, which 
means EPA will not know your identity, e-mail address, or other contact 
information unless you provide it in the body of your comment.

[[Page 69005]]

    ii. E-mail. Comments may be sent by e-mail to [email protected], 
Attention: Docket ID number OPP-2002-0294. In contrast to EPA's 
electronic public docket, EPA's e-mail system is not an ``anonymous 
access'' system. If you send an e-mail comment directly to the docket 
without going through EPA's electronic public docket, EPA's e-mail 
system automatically captures your e-mail address. E-mail addresses 
that are automatically captured by EPA's e-mail system are included as 
part of the comment that is placed in the official public docket, and 
made available in EPA's electronic public docket.
    iii. Disk or CD ROM. You may submit comments on a disk or CD ROM 
that you mail to the mailing address identified in Unit I.C.2. These 
electronic submissions will be accepted in WordPerfect or ASCII file 
format. Avoid the use of special characters and any form of encryption.
    2. By mail. Send your comments to: Public Information and Records 
Integrity Branch (PIRIB) (7502C), Office of Pesticide Programs (OPP), 
Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460-0001, Attention: Docket ID number OPP-2002-0294.
    3. By hand delivery or courier. Deliver your comments to: Public 
Information and Records Integrity Branch (PIRIB), Office of Pesticide 
Programs (OPP), Environmental Protection Agency, Rm. 119, Crystal Mall 
2, 1921 Jefferson Davis Hwy., Arlington, VA, Attention: Docket 
ID number OPP-2002-0294. Such deliveries are only accepted during the 
docket's normal hours of operation as identified in Unit I.B.1.

D. How Should I Submit CBI To the Agency?

     Do not submit information that you consider to be CBI 
electronically through EPA's electronic public docket or by e-mail. You 
may claim information that you submit to EPA as CBI by marking any part 
or all of that information as CBI (if you submit CBI on disk or CD ROM, 
mark the outside of the disk or CD ROM as CBI, and then identify 
electronically within the disk or CD ROM the specific information that 
is CBI). Information so marked will not be disclosed except in 
accordance with procedures set forth in 40 CFR part 2.
     In addition to one complete version of the comment that includes 
any information claimed as CBI, a copy of the comment that does not 
contain the information claimed as CBI must be submitted for inclusion 
in the public docket and EPA's electronic public docket. If you submit 
the copy that does not contain CBI on disk or CD ROM, mark the outside 
of the disk or CD ROM clearly that it does not contain CBI. Information 
not marked as CBI will be included in the public docket and EPA's 
electronic public docket without prior notice. If you have any 
questions about CBI or the procedures for claiming CBI, please consult 
the person listed under FOR FURTHER INFORMATION CONTACT.

E. What Should I Consider as I Prepare My Comments for EPA?

     You may find the following suggestions helpful for preparing your 
comments:
    1. Explain your views as clearly as possible.
    2. Describe any assumptions that you used.
    3. Provide copies of any technical information and/or data you used 
that support your views.
    4. If you estimate potential burden or costs, explain how you 
arrived at the estimate that you provide.
    5. Provide specific examples to illustrate your concerns.
    6. Make sure to submit your comments by the deadline in this 
notice.
    7. To ensure proper receipt by EPA, be sure to identify the docket 
ID number assigned to this action in the subject line on the first page 
of your response. You may also provide the name, date, and Federal 
Register citation.

II. What Action is the Agency Taking?

     EPA has received a pesticide petition as follows proposing the 
establishment and/or amendment of regulations for residues of a certain 
pesticide chemical in or on various food commodities under section 408 
of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a. 
EPA has determined that this petition contains data or information 
regarding the elements set forth in FFDCA section 408(d)(2); however, 
EPA has not fully evaluated the sufficiency of the submitted data at 
this time or whether the data support granting of the petition. 
Additional data may be needed before EPA rules on the petition.

List of Subjects

    Environmental protection, Agricultural commodities, Feed additives, 
Food additives, Pesticides and pests, Reporting and recordkeeping 
requirements.

    Dated: November 4, 2002.
Debra Edwards,
Director, Registration Division, Office of Pesticide Programs.

Summary of Petition

    The petitioner summary of the pesticide petition is printed below 
as required by FFDCA section 408(d)(3). The summary of the petition was 
prepared by the Wacker Biochem Corporation and represents the view of 
the petitioner. The petition summary announces the availability of a 
description of the analytical methods available to EPA for the 
detection and measurement of the pesticide chemical residues or an 
explanation of why no such method is needed.

PP 2E6514

Summary of Petitions

    EPA has received a pesticide petition (2E6514) from Wacker Biochem 
Corporation, 3301 Sutton Road, Adrian, MI 49221-9397 proposing, 
pursuant to section 408(d) of the FFDCA, 21 U.S.C. 346a(d), to amend 40 
CFR 180.950 to establish an exemption from the requirement of a 
tolerance for alpha-cyclodextrin (CAS No. 10016-20-3), beta-
cyclodextrin (CAS No. 7585-39-9), and gamma-cyclodextrin (CAS No. 
17465-86-0) in or on raw agricultural commodities resulting from the 
use of alpha-, beta-, and gamma-cyclodextrin as ingredients in 
pesticide formulations used in accordance with good agricultural 
practices. Alpha-cyclodextrin, beta-cyclodextrin, and gamma-
cyclodextrin are naturally occurring compounds derived from the 
degradation of starch by the glucosyltransferase enzyme (CGTase). D-
glucose molecules that are formed by the digestion of starch are joined 
``head-to-tail'' to form alpha-, beta-, and gamma-cyclodextrin which 
are ring-shaped molecules. Alpha-, beta-, and gamma-cyclodextrin are 
comprised of six, seven and eight D-glucose units, respectively. EPA 
has determined that the petition contains data or information regarding 
the elements set forth in section 408(d)(2) of the FFDCA; however, EPA 
has not fully evaluated the sufficiency of the submitted data at this 
time or whether the data support granting of the petition. Additional 
data may be needed before EPA rules on the petition.

A. Residue Chemistry

    1. Plant metabolism. While no studies have been conducted to 
evaluate the metabolism of alpha-, beta-, and gamma-cyclodextrin in 
plants, the metabolic products in plants are anticipated to be

[[Page 69006]]

ubiquitous, naturally occurring simple sugars and CO2. The 
anticipated plant metabolites are not of toxicological concern.
    2. Analytical method. An analytical method is not required for 
enforcement purposes since Wacker Biochem is requesting the 
establishiment of an exemption from the requirement of a tolerance 
without any numerical limitation.

B. Toxicological Profile

    Alpha-cyclodextrin: The Food & Agriculture Organization/World 
Health Organization (FAO/WHO) Joint Expert Committee on Food Additives 
(JECFA) has evaluated alpha-cyclodextrin and in 2001 allocated an 
acceptable daily intake (ADI) of ``not specified.'' This is the most 
desirable ADI allocation issued by JECFA.
    Beta-cyclodextrin: A GRAS (generally recognized as safe) petition 
was submitted by Roquette America Inc/American Maize-Products Co. for 
use as a formulation aid in the production of dry flavoring mixes 
(February 3, 1992) and for use as a flavor protectant (September 20, 
1996). A self-affirmation of beta-cyclodextrin as a flavor carrier in 
foods was completed by Cerestar USA on February 4, 1998. Wacker Biochem 
Corporation has submitted to the FDA an independent GRAS determination 
for beta-cyclodextrin for use as a flavor carrier or protectant in 
baked goods prepared from dry mixes, breakfast cereal, chewing gum, 
compressed, candies, gelatins and puddings, flavored coffee and tea, 
processed cheese products, dry mix for beverages, flavored savory 
snacks and crackers, dry mixes for soups (GRAS Notice No. 74). FDA has 
not yet completed its review of the self-affirmation.
    Gamma-cyclodextrin: Wacker Biochem Corporation has determined that 
gamma-cyclodextrin is generally recognized as safe (GRAS) when used as 
a stabilizer, emulsifier, carrier and formulation aid in foods.
    The toxicology and metabolism data relevant to the proposed 
tolerance exemption are summarized in Table 1.

                    Table 1.--Toxicity and Metabolism
------------------------------------------------------------------------
             Study                 Cyclo-dextrin           Result
------------------------------------------------------------------------
Acute oral toxicity              Alpha-             LD50 >10,000 mg/kg
                                                     (rat)
                                ----------------------------------------
                                 Beta-              LD50 >12,000 mg/kg
                                                     (rabbit)
                                ----------------------------------------
                                 Gamma-             LD50 >8,000 mg/kg
                                                     (rat)
------------------------------------------------------------------------
Acute dermal toxicity                               No data are
                                                     available
------------------------------------------------------------------------
Acute inhalation toxicity                           No data are
                                                     available
------------------------------------------------------------------------
Primary eye irritation           Alpha-             Crystalline form:
                                                     Eye irritant, but
                                                     not corrosive
                                                    50% suspension: Non-
                                                     irritant
                                ----------------------------------------
                                 Beta-              Slight irritant
                                ----------------------------------------
                                 Gamma-             Non-irritant
------------------------------------------------------------------------
Primary dermal irritation        Alpha-             Non-irritant
                                ----------------------------------------
                                 Beta-              Non-irritant
------------------------------------------------------------------------
Dermal sensitization             Alpha-             Non-sensitizer
                                ----------------------------------------
                                 Beta-              Non-sensitizer
                                ----------------------------------------
                                 Gamma-             Non-sensitizer
------------------------------------------------------------------------
28-Day feeding study: rodent     Alpha-             NOEL = 5% in the
                                                     diet
                                ----------------------------------------
                                 Beta-              NOEL = 5% in the
                                                     diet
------------------------------------------------------------------------
90-Day feeding study: rat        Alpha-             NOAEL = 20% in diet
                                                     highest dose tested
                                                     (HDT)
                                ----------------------------------------
                                 Beta-              NOAEL = 400 mg/kg/
                                                     day by gavage
                                ----------------------------------------
                                 Gamma-             NOAEL = 20% in diet
                                                     HDT
------------------------------------------------------------------------
90-Day feeding study: dog        Alpha-             NOAEL = 20% in diet
                                                     HDT
                                ----------------------------------------
                                 Beta-              NOEL = 2.5% in diet
                                                    LOEL = 5% in diet.
                                                     Hematology and
                                                     clinical
                                                     chemistryeffects
                                                     observed indicated
                                                     slight toxicity
                                ----------------------------------------
                                 Gamma-             NOAEL = 20% in diet
                                                     HDT

[[Page 69007]]

 
------------------------------------------------------------------------
Subchronic dermal toxicity                          No data are
                                                     available
------------------------------------------------------------------------
Chronic feeding and              Beta-              1-year dog
 oncogenicity                                       NOAEL = 1% in diet =
                                                     350 mg/kg/day
                                                    LOAEL = 2.5% in diet
                                                     = 925 mg/kg/day
                                                    Increased levels of
                                                     protein were
                                                     observed in urine
                                                    2-year rat:
                                                    NOEL for
                                                     oncogenicity = 6%
                                                     in diet
                                                    Small percentage is
                                                     absorbed by the
                                                     intestinal walls
                                                     and causes kidney
                                                     damage. Beta-
                                                     cyclodextrin is not
                                                     degraded in the
                                                     small intestine. In
                                                     the large
                                                     intestine, it
                                                     undergoes bacterial
                                                     degradation,
                                                     leading to gas
                                                     generation and
                                                     diarrhea
------------------------------------------------------------------------
Teratology study: rodent         Alpha-             Not teratogenic,
                                                     embryotoxic or
                                                     fetotoxic at doses
                                                     up to 20% of diets
                                                     in both rats and
                                                     rabbits HDT
                                ----------------------------------------
                                 Beta-              Not teratogenic,
                                                     embryotoxic or
                                                     fetotoxic at 5,000
                                                     mg/kg/day in rats
                                                     HDT and at 1,000 mg/
                                                     kg/day in rabbits
                                                     HDT
                                ----------------------------------------
                                 Gamma-             Not teratogenic,
                                                     embryotoxic or
                                                     fetotoxic at doses
                                                     up to 20% of diets
                                                     in both rats and
                                                     rabbits HDT
------------------------------------------------------------------------
2-Generation reproduction        Beta-              NOAEL in rats = 1%
                                                     in diet = 700 mg/kg/
                                                     day
                                                    LOAEL in dams and
                                                     offspring = 2.5% in
                                                     the diet
------------------------------------------------------------------------
Gene mutation test               Alpha-             Negative Ames test
                                ----------------------------------------
                                 Gamma-             Negative Ames test
------------------------------------------------------------------------
Structural chromosomal           Beta-              Negative in rats at
 aberration test                                     dose of 2% in diet
------------------------------------------------------------------------
Other genotoxic effects          Alpha-             Negative
                                                     micronucleus test
                                ----------------------------------------
                                 Gamma-             Negative
                                                     micronucleus test
------------------------------------------------------------------------
Metabolism (oral dosing)         Alpha              Absorption: 2% dose
                                                     absorbed
                                                    Distribution: Liver
                                                     (>0.05% dose) and
                                                     kidney (>0.01%
                                                     dose)
                                                    Metabolism:
                                                     Extensively and
                                                     predominantly
                                                     metabolized to C02
                                                     by intestinal flora
                                                    Excretion: 60% dose
                                                     expelled as CO2
                                                    26-33% dose
                                                     incorporated
                                                    7-14% dose excreted
                                                     in urine and feces
                                ----------------------------------------
                                 Beta-              Absorption: No
                                                     significant
                                                     absorption as
                                                     intact molecule.
                                                     Absorption as
                                                     sugars is similar
                                                     to that of glucose;
                                                     occurs via passive
                                                     transport
                                                    Distribution: Max.
                                                     0.9% in GI tract 60
                                                     hours after dosing
                                                    Metabolism:
                                                     Hydrolysis to open
                                                     chain dextrins and
                                                     glucose occurs in
                                                     the large intestine
                                                     by intestinal flora
                                                    Excretion: 66.8%
                                                     dose as CO2 in
                                                     expired air within
                                                     23 hours of dosing.
                                                     0.6% to 4% in feces
                                                     within 60 hours of
                                                     dosing
                                ----------------------------------------
                                 Gamma-             Absorption: >0.1% as
                                                     intact molecule
                                                    Metabolism: Rapid
                                                     and total
                                                     degradation to
                                                     glucose in the
                                                     upper intestinal
                                                     tract by intestinal
                                                     flora
                                                    Excretion: 60% dose
                                                     expelled as CO2
                                                    37% dose
                                                     incorporated
                                                    3% dose excreted in
                                                     urine and feces
------------------------------------------------------------------------

    1. Metabolite toxicology. Alpha-, beta-, and gamma-cyclodextrin are 
metabolized to simple sugars and CO2. These metabolites are 
also metabolites of the digestion of carbohydrates in the diet and have 
no significant toxicity.
    2. Endocrine disruption. Based upon the available data, alpha-, 
beta-, and gamma-cyclodextrin are not anticipated to disrupt the 
endocrine system.

C. Aggregate Exposure

    1. Food. Alpha-cyclodextrin, beta-cyclodextrin, and beta-
cyclodextrin are naturally occurring compounds and are used as food 
additives.
    Alpha-cyclodextrin food additive uses include: Carrier; 
encapsulating agent for food additives, flavorings and vitamins; 
stabilizer; and absorbent. The ADI is ``not specified.''

[[Page 69008]]

    Beta-cyclodextrin is used as a flavor carrier or protectant. See 
Table 2 for a detailed list of uses and the maximum concentrations.

                          Table 2.-Maximum Concentration of Beta-Cyclodextrin in Foods
----------------------------------------------------------------------------------------------------------------
                      Beta-Cyclodextrin Use                                    Maximum Concentration
----------------------------------------------------------------------------------------------------------------
Baked goods prepared from dry mixes breakfast cereal chewing gum                                              2%
 compressed candies
----------------------------------------------------------------------------------------------------------------
Gelatins and puddings flavored coffee and tea processed cheese                                                1%
 products dry mix for beverages
----------------------------------------------------------------------------------------------------------------
Flavored savory snacks and crackers                                                                         0.5%
----------------------------------------------------------------------------------------------------------------
Dry mixes for soups                                                                                         0.2%
----------------------------------------------------------------------------------------------------------------

     Gamma-cyclodextrin is used in foods such as bread spreads, frozen 
dairy desserts, ready to eat dairy desserts, desserts prepared from dry 
mixes, fruit fillings, cheese and cream fillings, chewing gum, dietary 
supplements. See Table 3 for a complete list of uses and the maximum 
concentrations.

                          Table 3.-Maximum Concentration of Gamma-Cyclodextrin in Foods
----------------------------------------------------------------------------------------------------------------
                      Gamma-Cyclodextrin Use                                 Maximum Use Concentration
----------------------------------------------------------------------------------------------------------------
Carrier for flavors, sweeteners and colors                                                                   <1%
----------------------------------------------------------------------------------------------------------------
Dry mixes for beverages                                                                                      <1%
----------------------------------------------------------------------------------------------------------------
Dry mixes for soups                                                                                          <1%
----------------------------------------------------------------------------------------------------------------
Dry mixes for dressings, gravies, and sauces                                                                 <1%
----------------------------------------------------------------------------------------------------------------
Dry mixes for puddings, gelatins, and fillings                                                               <1%
----------------------------------------------------------------------------------------------------------------
Instant coffee and instant tea                                                                               <1%
----------------------------------------------------------------------------------------------------------------
Coffee whiteners                                                                                             <1%
----------------------------------------------------------------------------------------------------------------
Compressed candies                                                                                           <1%
----------------------------------------------------------------------------------------------------------------
Chewing gum                                                                                                  <1%
----------------------------------------------------------------------------------------------------------------
Breakfast cereals (ready-to-eat)                                                                             <1%
----------------------------------------------------------------------------------------------------------------
Savory snacks and crackers                                                                                   <1%
----------------------------------------------------------------------------------------------------------------
Spices and seasonings                                                                                        <1%
----------------------------------------------------------------------------------------------------------------
Carrier for vitamins                                                                                         <1%
----------------------------------------------------------------------------------------------------------------
For use in dry food mixes and dietary supplements                                                          <90%1
----------------------------------------------------------------------------------------------------------------
Carrier for polyunsaturated fatty acids
----------------------------------------------------------------------------------------------------------------
For use in dry food mixes and dietary supplements                                                          <80%1
----------------------------------------------------------------------------------------------------------------
Flavor modifier
----------------------------------------------------------------------------------------------------------------
Soya milk                                                                                                    <2%
----------------------------------------------------------------------------------------------------------------
Stabilizer
----------------------------------------------------------------------------------------------------------------
Bread spreads (fat-reduced)                                                                                 <20%
----------------------------------------------------------------------------------------------------------------
Frozen dairy desserts                                                                                        <3%
----------------------------------------------------------------------------------------------------------------
Baked goods (excl. bread, but incl. dough and baking mixes)                                                  <2%
----------------------------------------------------------------------------------------------------------------
Bread                                                                                                        <1%
----------------------------------------------------------------------------------------------------------------
Fruit-based fillings                                                                                         <3%
----------------------------------------------------------------------------------------------------------------
Fat-based fillings                                                                                           <5%

[[Page 69009]]

 
----------------------------------------------------------------------------------------------------------------
Processed cheese                                                                                             <3%
----------------------------------------------------------------------------------------------------------------
Dairy deserts (ready-to-eat and prepared from dry mixes)                                                     <3%
----------------------------------------------------------------------------------------------------------------
1Percent by weight of gamma-cyclodextrin relative to the nutrient for which gamma-cyclodextrin is used as a
  carrier.

    The proposed use of alpha-, beta-, and gamma-cyclodextrin as 
ingredients in pesticide formulations is anticipated to result in no 
significant additional dietary exposure to alpha-, beta-, and gamma-
cyclodextrin.
    2. Drinking water. Any alpha-, beta-, and gamma-cyclodextrin in 
drinking water sources is anticipated to degrade to simple sugars and 
CO2 that will be used by plants as building blocks for the 
plant's growth. No significant exposure of alpha-, beta-, and gamma-
cyclodextrin via drinking water is anticipated.
    3. Non-dietary exposure. Cyclodextrins are used extensively in the 
cosmetic industry. Alpha-, beta-, and gamma-cyclodextrin are too large 
to be absorbed through the skin, so no significant systemic exposure is 
anticipated to result from the cosmetic use or other residential uses 
of alpha-, beta-, and gamma-cyclodextrin.

D. Cumulative Effects

    Alpha-, beta-, and gamma-cyclodextrin have no significant toxic 
effects for consideration of cumulative effects.

E. Safety Determination

    1. U.S. population. Alpha-, beta-, and gamma-cyclodextrin are low 
toxicity, naturally occurring compounds that are use as food additives. 
The D-glucose building blocks of alpha-, beta-, and gamma-cyclodextrin 
are also the result of digestion of starchy foods such as bread, rice, 
potatoes and pasta. Alpha-, beta-, and gamma-cyclodextrin are part of 
the current U.S. diet, and the proposed new uses of alpha-, beta-, and 
gamma-cyclodextrin as ingredients in pesticide formulations is not 
anticipated to contribute significantly to the amount of alpha-, beta-, 
and gamma-cyclodextrin in the U.S. diet. The proposed new use of alpha-
, beta-, and gamma-cyclodextrin for use as an inert ingredient in 
pesticide formulations has a reasonable certainty of no harm to the 
U.S. population.
    2. Infants and children. Alpha-, beta-, and gamma- cyclodextrin 
have no significant toxic effects that are specific to infants or 
children. The proposed new uses of alpha-, beta-, and gamma-
cyclodextrin as ingredients in pesticide formulations has a reasonable 
certainty of no harm to infants or children.

F. International Tolerances

     Alpha-cyclodextrin: The FAO/WHO JECFA has evaluated alpha-
cyclodextrin and in 2001 allocated an ADI of ``not specified.'' This is 
the most desirable ADI and is limited to low toxicity compounds.
    Beta-cyclodextrin: A request was submitted to the CODEX 
Alimentarius Commission for additive clearance in the General Standard 
on Food Additives (INS No. 459) at a maximum level of 50,000 
milligrams/kilogram (mg/kg) in food category 5.3, for chewing gum. A 
new monograph for beta-cyclodextrin has been published in the First 
Supplement to the Fourth Edition of the Food Chemicals Codex. Beta-
cyclodextrin is published in Annex V of the Official Journal of the 
European Communities-Food Additives as a carrier only for food 
additives up to 1 gram/kilogram food. An ADI of 5 mg/kg body weight was 
established at the February 1995 joint FAO/WHO meeting of the expert 
committee on food additives and is published in WHO Food Additive 
Series 35.
    Gamma-cyclodextrin: The FAO/WHO JECFA has evaluated alpha-
cyclodextrin and in 2,000 (53rd meeting) allocated an ADI of ``not 
specified.'' This is the most desirable ADI and is limited to low 
toxicity compounds.
[FR Doc. 02-28909 Filed 11-13-02; 8:45 am]
BILLING CODE 6560-50-S