[Federal Register Volume 68, Number 223 (Wednesday, November 19, 2003)]
[Notices]
[Pages 65281-65285]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-28913]


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ENVIRONMENTAL PROTECTION AGENCY

[OPP-2003-0365; FRL-7334-3]


Aminoethoxyvinylglycine hydrochloride (aviglycine HCl); Notice of 
Filing a Pesticide Petition to Establish 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 identification (ID) number OPP-
2003-0365, must be received on or before December 19, 2003.

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: Denise Greenway, Biopesticides and 
Pollution Prevention Division (7511C), Office of Pesticide Programs, 
Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460-0001; telephone number: (703) 308-8263; 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 entities may include, but are not limited to:
    [sbull] Crop production (NAICS 111)
    [sbull] Animal production (NAICS 112)
    [sbull] Food manufacturing (NAICS 311)
    [sbull] Pesticide manufacturing (NAICS 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-2003-0365. 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 EPA's 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.1. 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

[[Page 65282]]

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-2003-0365. 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-2003-0365. 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-2003-0365.
    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-2003-0365. 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);

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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 7, 2003.
 Phil Hutton,
Acting Director, Biopesticides and Pollution Prevention 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.

Valent BioSciences Corporation

PP 3F6772

    EPA has received a pesticide petition (3F6772) from Valent 
BioSciences Corporation, 870 Technology Way, Libertyville, IL 60048, 
proposing pursuant to section 408(d) of the FFDCA, 21 U.S.C. 346a(d), 
to amend 40 CFR part 180 by establishing a tolerance for residues of 
the biochemical pesticide aminoethoxyvinylglycine hydrochloride 
(aviglycine HCl), formerly designated as aminoethoxyvinylglycine (AVG), 
in or on the stone fruits crop group, excepting cherries, at 0.170 part 
per million (ppm).
    Pursuant to section 408(d)(2)(A)(i) of the FFDCA, as amended, 
Valent BioSciences Corporation has submitted the following summary of 
new information, data, and arguments in support of their pesticide 
petition (3F6772). This summary was prepared by Valent BioSciences 
Corporation and EPA has not fully evaluated the merits of the pesticide 
petition. The summary may have been edited by EPA if the terminology 
used was unclear, the summary contained extraneous material, or the 
summary unintentionally made the reader conclude that the findings 
reflected EPA's position and not the position of the petitioner.
    In addition to the new data summarized below, however, Valent 
BioSciences Corporation also is relying on a summary of information, 
data, and arguments previously submitted by Abbott Laboratories, 
pursuant to section 408(d)(2)(A)(i) of the FFDCA as amended, in support 
of a prior Abbott Laboratories pesticide petition 9G5048 that sought 
temporary tolerances for residues of AVG in or on the stone fruit crop 
group. This Abbott Laboratories request, including the referenced 
summarized information, was published in the Federal Register of March 
10, 1999 (64 FR 11872) (FRL-6067-5). EPA issued a final rule, published 
in the Federal Register of June 10, 1999 (64 FR 31124) (FRL-6080-4), in 
which it announced the establishment of the temporary tolerances 
requested by Abbott Laboratories for residues of aminoethoxyvinylglcine 
in or on the stone fruit crop group at 0.170 ppm, with an expiration 
date of April 1, 2001. Subsequently, Valent BioSciences Corportion 
submitted a pesticide petition (9G5048, transferred from Abbott 
Laboratories) that sought to extend the temporary tolerances for AVG in 
or on the stone fruit crop group originally obtained by Abbott 
Laboratories. Notice of this previous pesticide petition by Valent 
BioSciences Corporation, which also relied, in part, on the referenced 
summary of information previously prepared and submitted by Abbott 
Laboratories, was published in the Federal Register of March 28, 2001 
(66 FR 16931) (FRL-6775-1). EPA issued a final rule, published in the 
Federal Register of July 12, 2001 (66 FR 36477) (FRL-6788-7), 
announcing the establishment of the temporary tolerances requested by 
Valent BioSciences Corporation for residues of the plant regulator AVG 
in or on the stone fruit crop group at 0.170 ppm, with an expiration 
date of December 21, 2003. It is the original summary of information 
previously submitted by Abbott Laboratories, and previously relied upon 
by Valent BioSciences Corporation, that Valent BioSciences Corporation 
once again is relying upon in connection with this new pesticide 
petition. EPA has not republished the summary of information initially 
submitted by Abbott Laboratories and published in the March 10, 1999 
Federal Register, except where EPA believes such information would be 
helpful in understanding the new data.

A. Product Name and Proposed Use Practices

    Aminoethoxyvinylglycine hydrochloride (aviglycine HCl), which was 
previously designated as aminoethoxyvinylglycine (AVG), is a plant 
growth regulator used in the harvest management of apples, pears, and 
stone fruit (excluding cherries). It is used at the rate of 50 grams 
active ingredient per acre. Applications to apples are made once a 
season at 4 weeks before harvest; proposed use on stone fruit (except 
cherries) is for application 7 to 10 days before harvest.

B. Product Identity/Chemistry

    1. Identity of the pesticide and corresponding residues. A study 
designed to determine whether uptake, translocation and metabolism of 
aminoethoxyvinylglycine hydrochloride occurs in apples identified seven 
minor metabolites in addition to the primary metabolite, N-acetyl-
aminoethoxyvinylglycine. The study was not meant as a measure of the 
amount of aminoethoxyvinylglycine hydrochloride residues and 
metabolites found in apples under normal field conditions. The only 
significant incorporation of aminoethoxyvinylglycine hydrochloride in 
apple tissues, following brush-on application at high rates, resulted 
from absorption from the peel rather than translocation from the 
leaves. Aminoethoxyvinylglycine hydrochloride is also metabolized in 
the tissues to form N-acetyl-aminoethoxyvinylglycine and several other 
minor metabolites, and is partially degraded on the apple surface to 
water-soluble products that may be formed due to microbial and/or 
photodegradative action.
    2. Magnitude of residue at the time of harvest and method used to 
determine the residue. Crops in residue trials were treated at maximum 
label rates, or above, and harvested at the specified minimum treatment 
to harvest intervals. Residue data for apples previously submitted by 
Abbott Laboratories and reviewed by EPA indicated that at the proposed 
use rates, no quantifiable residues were present in or on the food 
commodities at 21 days after treatment. Additional pome fruit residue 
data generated internationally has been provided to EPA by Valent 
BioSciences Corporation. Residues on representative stone fruit were 
typically below levels of quantitation, maximum residues on plums at 7 
days were 0.142 ppm, and maximum residues on cherries were 0.490 ppm at 
7 days. The proposed tolerance excludes use on cherries.
    Analytical Enforcement Methodology. There is a practical method for 
detecting and measuring levels of aviglycine HCI in or on food with a 
limit of detection (LOD) that allows monitoring of food

[[Page 65284]]

with residues at or above the levels set in these proposed tolerances. 
Abbott Laboratories has submitted a practical analytical methodology 
for detecting and measuring levels of aviglycine HCI in or on raw 
agricultural commodities (RACs). The proposed analytical method for 
determining residues is by high-performance liquid chromatography 
(HPLC). The HPLC/fluorescence detector analytical method used in the 
apple residue studies has been validated by an independent laboratory 
and provided to the Food and Drug Administration (FDA). This method was 
modified slightly for analysis of residue on peaches, plums, and 
cherries. This modified method has been validated by an independent 
laboratory. The limit of quantitation (LOQ) was 0.080 ppm for all 
matrices analyzed by either method. It was determined that residues on 
treated commodities were stable for a period of 22 months in frozen 
storage.

C. Mammalian Toxicological Profile

    1. Acute toxicity. Aviglycine HCl has low acute oral, dermal, and 
inhalation toxicity. The oral lethal dose (LD)50 in rats is 
>5,000 milligrams/kilogram (mg/kg), the dermal LD50 is 
>2,000 mg/kg and the inhalation 4-hour lethal concentration 
(LC)50 is >5.00 milligrams/Liter (mg/L) air. Aviglycine HCl 
is not a skin sensitizer in guinea pigs, and is not irritating to the 
skin and eyes of rabbits. End-use formulations of aviglycine HCl have 
similar low acute toxicity profiles.
    2. Genotoxicity. Aviglycine HCl does not induce gene mutations in 
bacterial and mammalian cells, chromosome aberrations in mammalian 
cells or deoxyribonucleic acid (DNA) damage in bacterial cells in in 
vitro test systems. Similarly, it does not exhibit a clastogenic effect 
in vivo in the rat micronucleus test. Therefore, there is no evidence 
to suggest a genotoxic hazard at any of the three main levels of 
genetic organization.
    3. Reproductive and developmental toxicity. In the rabbit 
developmental toxicity study with aviglycine HCl, there was no evidence 
of teratogenicity or other embryotoxic effects at the highest dose 
levels tested, although maternal toxicity was evident. The rabbit 
maternal no observed adverse effect level (NOAEL) was established at 
0.4 mg a.i./kg body weight/day (mg a.i./kg bwt/day) based on reduced 
body weight gains and food consumption, and decreased defecation. The 
developmental NOAEL was established at 0.4 mg a.i./kg bwt/day based on 
fetal body weights. In the rat test the maternal NOAEL was established 
at 1.77 mg a.i./kg bwt/day based on inhibition of body weight gain and 
reduced food consumption. The developmental NOAEL was found to be 1.77 
mg a.i./kg bwt/day based on decreased mean fetal body weights and 
reduced ossification. The developmental and maternal lowest observed 
adverse effect levels (LOAELs) were established at 8.06 mg a.i./kg bwt/
day. Aviglycine HCl was evaluated in a rat 2-generation reproduction 
study submitted by Abbott Laboratories. Based on reductions in body 
weight, changes in organ weights, and an increased incidence of 
microscopic findings, the parental NOAEL was established at 0.8 mg 
a.i./kg bwt/day. The NOAEL for reproductive toxicity was established at 
4.0 mg a.i./kg bwt/day and the neonatal toxicity NOAEL was established 
at 2.5 mg a.i./kg bwt/day.
    4. Subchronic toxicity. Subchronic 90-day feeding studies were 
conducted with rats, mice, and dogs. In a 90-day feeding study in rats, 
the NOAEL was 0.4 mg a.i./kg bwt/day for males and females based on 
increased incidence of periportal hepatocellular vacuolation in the 
liver. In the 90-day feeding study in mice, the NOAEL was established 
at 10 mg a.i./kg bwt/day for males and females - based on decreased 
body weight and histopathological changes in the liver (both sexes), in 
the testis (males) and the adrenal (females) at 25 mg a.i./kg bwt/day. 
For dogs, the NOAEL was established at 0.6 mg a.i./kg bwt/day - based 
on inappetence, low body weight gain and centrilobular 
histopathological changes in the liver at 1.2 mg a.i./kg bwt/day. Note 
that the liver vacuolation is considered an adaptive change. Increased 
vacuolation of the liver was not observed in the 52-week chronic rat 
study or the 104-week rat oncogenicity study. A 21-day repeat dose 
dermal toxicity study in rats was carried out at 0, 100, 500, and 1,000 
mg a.i./kg bwt/day. The NOAEL is 1,000 mg a.i./kg bwt/day; a LOAEL was 
not determined.
    5. Chronic toxicity. Chronic studies with aviglycine HCl were 
conducted on rats to determine oncogenic potential and/or chronic 
toxicity of the compound. The NOAEL for the 1-year chronic study was 
0.7 mg a.i./kg bwt/day for males and females based on decreases in body 
weights, food consumption, testicular tubular and epithelial 
vacuolation, and pancreatic acinar cell atrophy. The rat 
carcinogenicity study with aviglycine HCl confirmed the substance has 
no carcinogenic potential. There was no evidence of cell necrosis that 
could be a preliminary stage before tumor genesis, and time of death 
was similar to controls. During the 2-year carcinogenicity study, the 
administration of aviglycine HCl at 7 mg a.i./kg bwt/day was associated 
with body weight and food consumption reductions, increases in the 
incidence of adrenal focal medullary cell hyperplasia, testicular 
tubular atrophy, and other associated findings in the testis and 
epididymis, ocular cataracts, and pancreatic lobular/acinar cell 
atrophy. The NOAEL was established at 0.7 mg a.i./kg bwt/day.

D. Aggregate Exposure

    1. Dietary exposure--i. Food. Expected dietary exposures from 
residues of aviglycine HCl would occur through apples, pears, peaches, 
nectarines, plums, and processed pome and stone-fruits. Acute and 
chronic dietary exposure assessments were conducted using a Tier I 
approach. This Tier I assessment incorporated; tolerance level residues 
for all commodities; assumption of 100% crop-treated for all crops; 
default processing factors and consumption data from the 1994 through 
1998 U.S. Department of Agriculture (USDA) Continuing Surveys of Food 
Intakes by Individuals (CSFII) (USDA), 1994, 1995, 1996, and 1998). 
Estimates of chronic and acute dietary exposure were calculated using 
Dietary Exposure Evaluation Module Food Commodity Intake Database 
(DEEM-FCID\TM\) software (Novigen, 2001). The resulting exposures were 
compared to a chronic reference dose (RfD) of 0.007 mg a.i./kg bwt/day 
and an acute NOAEL of 1.77 mg a.i./kg bwt/day. The RfD is based on the 
NOAEL of 0.7 mg a.i./kg bwt/day from the rat chronic toxicity study 
(52-week) and the rat carcinogenicity feeding study (104-week) with a 
100-fold uncertainty factor (UF) to account for intraspecies and 
interspecies variations. The acute NOAEL is based on the rat oral 
developmental toxicity study.
    Chronic dietary exposure estimates for the overall U.S. population 
and 24 population subgroups, including infants and children, are well 
below the chronic RfD. Estimated daily exposures from tolerance level 
residues and a 100% crop treated assumption for all crops were 15.9% of 
the RfD or less for all populations examined. Acute dietary exposure 
was estimated for the overall U.S. population and the population 
subgroups:
    a. All infants.
    b. Nursing infants.
    c. Non-nursing infants.
    d. Children 1 to 2 years of age.
    e. Adult 20 to 49 years of age.
    f. Females 13 t0 49 years of age.
    g. Adults 50 years and older.

[[Page 65285]]

    Estimated daily exposures from tolerance level residues ( at the 
95\th\ percentile) and a 100% crop treated assumption for all crops 
resulted in margins of exposure (MOEs) greater than 430 for all 
population groups examined. The results of both the chronic and acute 
dietary exposure analyses clearly demonstrate a reasonable certainty 
that no harm will result from the proposed agricultural uses of 
aviglycine HCI.
    ii. Drinking water. Aviglycine HCl is highly unlikely to 
contaminate ground water resources due to its high soil sorption, and 
short soil and water/sediment half-lives. Study results show that 
aviglycine HCl is easily adsorbed to soils, principally onto clay 
particles. Half-lives in soils vary between 1.7 and 4.7 days. Water-
sediment studies have shown that aviglycine HCl will be readily 
adsorbed to sediment where it is mineralized and incorporated into the 
organic fraction of the sediment. Biodegradation occurs in both 
systems. The half-life of aviglycine HCl in the aqueous phase and total 
water/sediment system was calculated to be 1.5 and 4.3 days 
respectively. An aviglycine HCI water concentration assessment was 
conducted using EPA first tier screening models. FQPA Index Reservoir 
Screening Tool (FIRST) was used for surface water concentration 
assessment and screening concentration in ground water (SCI-GROW) was 
used for ground water assessment. There were no estimated ground water 
concentrations according to SCI-GROW. Peak surface water concentrations 
estimated using FIRST were 1,283 and the estimated annual average was 
0.021 part per billion (ppb), assuming 87% crop treated. The 
contribution of drinking water to aggregate risk is considered to be 
negligible.
    2. Non-dietary exposure. Aviglycine HCl has no product 
registrations for residential non-food uses. Non-occupational, non-
dietary exposure for aviglycine HCl has thus been estimated to be 
extremely small. Therefore, the potential for non-dietary exposure is 
insignificant. The exposure from the commercial use is expected to be 
dermal in nature. A 21-day repeat dose dermal toxicity study resulted 
in no significant treatment related effects at 1,000 mg a.i./kg bwt/
day, the highest dose tested (HDT).

E. Cumulative Exposure

    Consideration of a common mechanism of toxicity is not necessary at 
this time because there is no indication that toxic effects of 
aviglycine HCl would be cumulative with those of any other chemical 
compounds. Aviglycine HCl has a novel mode of action compared to other 
currently registered active ingredients. Therefore, Valent BioSciences 
Corporation believes it is appropriate to consider only the potential 
risks of aviglycine HCl in an aggregate risk assessment.

F. Safety Determination

    1. U.S. population. Aviglycine HCl is an amino acid which has been 
generated through a fermentation of a soil microorganism. Using the 
chronic exposure assumptions and the proposed RfD described above, the 
dietary exposure to aviglycine HCl for the U.S. population was 
calculated to be 2.2% of the RfD. Therefore, taking into account the 
proposed uses, it can be concluded with reasonable certainty that 
residues of aviglycine HCl in food and drinking water will not result 
in unacceptable levels of human health risk.
    2. Infants and children. FFDCA section 408 (b)(2)(C)(i) provides 
that EPA shall apply an additional safety factor for infants and 
children to account for prenatal and postnatal toxicity and the lack of 
completeness of the data base. Only when there is no indication of 
increased sensitivity of infants and children and when the data base is 
complete, may the extra safety factor be removed. In the case of 
aviglycine HCl, the toxicology data base is complete. There is no 
indication of increased sensitivity in the data base overall, and 
specifically, there is no indication of increased sensitivity in the 
developmental and multi-generation reproductive toxicity studies. 
Therefore, Valent BioSciences Corporation concludes that there is no 
need for an additional safety factor and a safety factor of 100 be used 
for the assessment. Using the chronic exposure assumptions and the 
proposed RfD described above, the dietary exposure to aviglycine HCl 
for non-nursing infants, the most highly exposed population subgroup, 
was calculated to be 0.001110 mg a.i./kg bwt/day or 15.9% of the RfD. 
Daily exposure for the overall U.S. population was estimated to be 
0.000153 mg a.i./kg bwt/day. The proposed tolerances will utilize 2.2% 
of the RfD for the U.S. population.

G. Effects on the Immune and Endocrine Systems

    Lifespan, and multigenerational studies on mammals, and acute and 
subchronic studies on aquatic organisms and wildlife did not reveal any 
definite immune or endocrine effects. An immunotoxicity study in rats 
at 0, 1.25, 5, and 15 mg a.i./kg bwt/day presented a NOAEL of 5 mg 
a.i./kg bwt/day based on decreased primary antibody (igM) response to 
sheep red blood cells; decreased absolute and relative thymus weights; 
and decreased body weight, food consumption, and food efficiency at the 
high dose level. The LOAEL is 15 mg a.i./kg bwt/day. Any endocrine 
related effects would have been detected in this definitive array of 
required tests. The probability of any such effect due to agricultural 
uses of aviglycine HCl is considered negligible.

H. Existing Tolerances

    Time limited tolerances have been established for the residues of 
aminoethoxyvinylglycine hydrochloride (aviglycine HCl, formerly 
aminoethoxyvinylglycine (AVG)) in or on the following food commodities:

------------------------------------------------------------------------
            Commodity              Parts per million    Expiration date
------------------------------------------------------------------------
Apple                             0.08                December 21, 2003
------------------------------------------------------------------------
Pear                              0.08                December 21, 2003
------------------------------------------------------------------------

    Temporary tolerances have been established for the residues of 
aminoethoxyvinylglycine hydrochloride (aviglycine HCl, formerly 
aminoethoxyvinylglycine (AVG)) in or on the following food commodities:

------------------------------------------------------------------------
            Commodity              Parts per million    Expiration date
------------------------------------------------------------------------
Fruit, stone, group 12            0.170               December 21, 2003
------------------------------------------------------------------------

I. International Tolerances

    There are no codex maximum residue limits for use of 
aminoethoxyvinylglycine hydrochloride on apples or pears, stone fruits, 
or on any other crop.
[FR Doc. 03-28913 Filed 11-18-03; 8:45 am]
BILLING CODE 6560-50-S