[Federal Register Volume 67, Number 205 (Wednesday, October 23, 2002)]
[Notices]
[Pages 65115-65118]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-26993]


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ENVIRONMENTAL PROTECTION AGENCY

[OPP-2002-0275; FRL-7276-8]


Hydrogenated Starch Hydrolysate; Notice of Filing a Pesticide 
Petition to Establish an Exemption From the Requirement of a Tolerance 
for a Certain Pesticide Chemical in or on Food

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 a 
certain pesticide chemical in or on various food commodities.

DATES: Comments, identified by docket ID number OPP-2002-0275 must be 
received on or before November 22, 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, Registration Division 
(7505C), 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].

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 categories and 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 the table could also be 
affected. The North American Industrial Classification System (NAICS) 
codes have been provided to assist you and others in determining 
whether or not this action might apply to certain entities. If you have 
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-2002-0275. 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

[[Page 65116]]

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-2002-0275. 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.
    ii. E-mail. Comments may be sent by e-mail to [email protected], 
Attention: Docket ID Number OPP-2002-0275. 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-2002-0275.
    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-2002-0275. 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

[[Page 65117]]

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: October 9, 2002.
Debra Edwards,
Acting 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 petitioner, 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.

Hydrogenated Starch Hydrolysate

PP 2E6503

    EPA has received a pesticide petition (2E6503) from Grain 
Processing Corporation, 1600 Oregon Street, Muscatine, Iowa 52761 
proposing, pursuant to section 408(d) of the FFDCA, 21 U.S.C. 346a(d), 
to amend 40 CFR part 180 to establish an exemption from the requirement 
of a tolerance for hydrogenated starch hydrolysate (HSH) in or on 
growing crops or when applied to the raw agricultural commodity after 
harvest. 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. Like any other carbohydrate, HSH degrades 
readily in the soil and other substrates into carbon dioxide and water. 
HSH (CAS number 68425-17-2) is a carbohydrate polymer with a 
theoretical molecular weight (in amu) of 1,000-3,600. It can be 
supplied as a liquid syrup or white powder. The empirical formula of 
the components of HSH are:

------------------------------------------------------------------------
            Components                            Formula
------------------------------------------------------------------------
Sorbitol                           C6H14O6
Maltitol                           C12H24O11
Hydrogenated polysaccharides       C12H24O11 plus C6H10O5 for each
                                    additional glucose moiety in the
                                    chain
------------------------------------------------------------------------

    HSH is highly soluble in water. The aqueous solution has a pH range 
of 4.0-6.0. It hydrolyzes slowly to glucose and sorbitol. It combusts 
at 300 0C to carbon dioxide and water.
    2. Analytical method. The qualitative analysis of HSH in the 
products to which it has been added may be accomplished by extraction 
of the sorbitol and maltitol moieties with appropriate solvents, 
followed by gas chromatography of the extracts. Similarly, the quantity 
of HSH occurring in food may be estimated by determining the amount of 
maltitol recovered and applying an appropriate factor. Information on 
the sensitivity and reproducibility of the method has also been 
developed.
    3. Magnitude of residues. HSH is readily degraded by microorganisms 
on leaf surfaces and in the soil. Due to the solubility of this 
carbohydrate, rain, or other water sources wash the carbohydrate into 
the soil where it is degraded by microorganisms into carbon dioxide and 
water. No harmful residues are produced.

B. Toxicological Profile

    HSH has been widely used in foods since the early 1980s. It has 
been marketed extensively by Roquette, Lonza and SPI Polyols for years. 
Grain Processing Corporation produces HSH using a process that is 
equivalent to the process petitioned to the Food and Drug 
Administration by Lonza and Roquette Freres for GRAS (generally 
recognized as safe) affirmation. In support of the safety of our HSH, 
Grain Processing Corporation and SPI Polyols cites data

[[Page 65118]]

submitted by Roquette in its Lycasin[reg] 80/55 petition regarding 
numerous studies relating to the safety of the ingredient, including 
reports on: Digestion, absorption, distribution and excretion; acute 
oral toxicity, subchronic toxicity, genotoxicity, reproduction, 
biological tolerance, human exposure, and laxation effects.
    1. Acute toxicity. The acute oral toxicity of HSH has been 
evaluated. The acute oral lethal dose (LD50) of HSH is 
greater than 10 grams/kilogram (g/kg).
    2. Genotoxicty. As stated in Roquette's GRAS submission of 
Lycasin[reg] 80/55, HSH is nonmutagenic and nonclastogenic in short-
term in vivo, and in vitro studies.
    3. Reproductive and developmental toxicity. Again as noted in 
Roquette's GRAS submission of Lycasin[reg] 80/55 HSH products, when 
administered to rats over 3-generations, produce no significant effects 
on reproduction.
    4. Subchronic toxicity. In Roquette's GRAS submission for 
Lycasin[reg] 80/55, it is noted that when administered orally to rats 
and dogs in amounts of 5 g/kg to 15 g/kg of body weight per day for 90 
days, HSH produced no toxicologically meaningful effects which could 
not be accounted for by the presence of sorbitol. The possible 
treatment related effects are aggregates in the renal pelvis of some 
rats, diarrhea in most dogs, and minimal ectasia in the renule tubules 
of some dogs.
    5. Chronic toxicity. HSH is used extensively in foods. Grain 
Processing Corporation is not aware of any chronic toxic effects 
associated with this product.
    6. Animal metabolism. The GRAS submission for Lycasin[reg] 80/55 
developed by Roquette Freres states that over 96% of HSH (Lycasin[reg] 
80/55) is broken down by the mammalian digestive system into the GRAS 
substances, glucose and sorbitol, the remaining 4% is in the form of 
maltitol. One half of the maltitol is excreted in the feces and the 
majority of the remainder is excreted in the urine.
    Within the first 2 hours after oral administration of HSH 
(Lycasin[reg] 80/55), virtually all of the glucose to glucose bonds are 
broken down in the digestive system, producing a resulting mixture of 
glucose, sorbitol, and maltitol. Within 7 hours, 95% of the total 
maltitol, is broken down into glucose and sorbitol. Of the remaining 5% 
of maltitol, 2% is found in the digestive tube and fecal contents, less 
than 1% is found in the plasma, and approximately 1% is excreted in the 
urine.
    There is no accumulation of maltitol in the plasma, liver, kidneys, 
or spleen of rats fed 13.5 g/kg/day of Lycasin[reg] 80/55 for 10 days 
irrespective of whether measurements are made 12 hours or 10 days after 
cessation of dosing.
    Lycasin[reg] 80/55 at the dose levels tested, 30 to 180 grams per 
day, produces no significant variations in the clinical chemical, 
hematological or urinary profile of humans with the exception of 
glucose and insulin peaks which are less than 50% of those produced by 
equivalent amounts of glucose, and 50 to 90% of those produced by 
sucrose. The only significant clinical effects are flatulence and 
diarrhea, which can be accounted for by the presence of free and bound 
sorbitol. The mean laxative threshold in adult males is approximately 
180 grams per day, while in females the threshold is approximately 100 
grams per day. In children, the threshold is approximately 60 grams per 
day, about half that of adults.
    7. Metabolite toxicology. None of the metabolites of HSH are 
considered to be of toxicological significance for the use of this 
product as a pesticide inert ingredient.
    8. Endocrine disruption. Grain Processing Corporation is not aware 
of any endocrine disruption with the use of this product.

C. Aggregate Exposure

    1. Dietary exposure. This product is already used extensively in 
foods. Studies have shown that it is safe even when consumed at levels 
of up to 100 g/day.
    i. Food. As a pesticide inert ingredient HSH will not result in any 
harmful exposure. The proposed use will not result in any dietary 
exposure beyond what is currently present in commonly consumed foods.
    ii. Drinking water. There is no anticipated human exposure to HSH 
through drinking water. HSH is expected to be degraded by soil 
microorganisms to carbon dioxide and water before it reaches surface or 
ground water. Moreover, in water, HSH hydrolyses to glucose and 
sorbitol.
    2. Non-dietary exposure. No significant non-dietary human exposure 
to HSH is anticipated.

D. Cumulative Effects

    HSH is a widely used food ingredient, is readily digested by 
humans, and there are no cumulative effects. Except for possible 
occupational exposure of the pesticide mixer/loader/applicator, the 
proposed use of HSH will not result in the exposure of other persons.

E. Safety Determination

    1. U.S. population. The proposed use of HSH does not pose a safety 
concern for the U.S. population due to the non-toxic nature of the 
compound and the absence of exposure.
    2. Infants and children. Infants and children will not be exposed 
to HSH from its proposed use as a pesticide inert ingredient.

F. International Tolerances

    Grain Processing Corporation is unaware of any international 
tolerances for this product. HSH was developed by a Swedish company in 
the 1960's and has been widely used by the food industry for many 
years, especially in confectionery products. Roquette's petition 
indicates that Roquette's Lycasin[reg] products have been approved for 
use in food in Europe since 1963, as indicated below.

------------------------------------------------------------------------
                  Country                         Year of Approval
------------------------------------------------------------------------
Sweden                                      1963 (reaffirmed in 1975)
------------------------------------------------------------------------
Switzerland                                 1968
------------------------------------------------------------------------
Norway                                      1975
------------------------------------------------------------------------
Finland                                     1975 (reaffirmed in 1980)
------------------------------------------------------------------------
Denmark                                     1976
------------------------------------------------------------------------


[FR Doc. 02-26993 Filed 10-22-02; 8:45 am]
BILLING CODE 6560-50-S