[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]
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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.
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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
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Study Cyclo-dextrin Result
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Acute oral toxicity Alpha- LD50 >10,000 mg/kg
(rat)
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Beta- LD50 >12,000 mg/kg
(rabbit)
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Gamma- LD50 >8,000 mg/kg
(rat)
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Acute dermal toxicity No data are
available
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Acute inhalation toxicity No data are
available
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Primary eye irritation Alpha- Crystalline form:
Eye irritant, but
not corrosive
50% suspension: Non-
irritant
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Beta- Slight irritant
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Gamma- Non-irritant
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Primary dermal irritation Alpha- Non-irritant
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Beta- Non-irritant
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Dermal sensitization Alpha- Non-sensitizer
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Beta- Non-sensitizer
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Gamma- Non-sensitizer
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28-Day feeding study: rodent Alpha- NOEL = 5% in the
diet
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Beta- NOEL = 5% in the
diet
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90-Day feeding study: rat Alpha- NOAEL = 20% in diet
highest dose tested
(HDT)
----------------------------------------
Beta- NOAEL = 400 mg/kg/
day by gavage
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Gamma- NOAEL = 20% in diet
HDT
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90-Day feeding study: dog Alpha- NOAEL = 20% in diet
HDT
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Beta- NOEL = 2.5% in diet
LOEL = 5% in diet.
Hematology and
clinical
chemistryeffects
observed indicated
slight toxicity
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Gamma- NOAEL = 20% in diet
HDT
[[Page 69007]]
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Subchronic dermal toxicity No data are
available
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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
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Teratology study: rodent Alpha- Not teratogenic,
embryotoxic or
fetotoxic at doses
up to 20% of diets
in both rats and
rabbits HDT
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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
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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
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Gamma- Negative Ames test
------------------------------------------------------------------------
Structural chromosomal Beta- Negative in rats at
aberration test dose of 2% in diet
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Other genotoxic effects Alpha- Negative
micronucleus test
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Gamma- Negative
micronucleus test
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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
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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
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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
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Beta-Cyclodextrin Use Maximum Concentration
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Baked goods prepared from dry mixes breakfast cereal chewing gum 2%
compressed candies
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Gelatins and puddings flavored coffee and tea processed cheese 1%
products dry mix for beverages
----------------------------------------------------------------------------------------------------------------
Flavored savory snacks and crackers 0.5%
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Dry mixes for soups 0.2%
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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]
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