[Federal Register Volume 68, Number 219 (Thursday, November 13, 2003)]
[Notices]
[Pages 64343-64347]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-28425]


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ENVIRONMENTAL PROTECTION AGENCY

[OPP-2003-0346; FRL-7333-6]


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-
2003-0346, must be received on or before December 15, 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-2003-0346. 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

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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 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-2003-0346. 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-2003-0346. 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-2003-0346.
    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-2003-0346. 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.

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    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 31, 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 6F4632

    EPA has received a pesticide petition (6F4632) transferred from 
Abbott Laboratories and 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 permanent tolerances for residues of the biochemical 
pesticide aminoethoxyvinylglycine hydrochloride (aviglycine HCl), 
formerly designated as aminoethoxyvinylglycine (AVG), in or on the food 
commodities apple and pear at 0.08 part per million (ppm). EPA issued a 
final rule, published in the Federal Register of July 12, 2001 (66 FR 
36481) (FRL-6790-7), which announced that it established time-limited 
tolerances for residues of the plant regulator AVG in or on the food 
commodities apples and pears at 0.08 ppm, with an expiration date of 
December 21, 2003. EPA issued a final rule, published in the Federal 
Register of May 7, 1997 (62 FR 24835) (FRL-5713-5), which announced 
that it established time-limited tolerances for residues of the plant 
regulator AVG in or on the food commodities apples and pears at 0.08 
ppm, with an expiration date of April 1, 2001. A correction to this 
rule was published in the Federal Register of October 29, 1997 (62 FR 
56089) (FRL-5751-5), which announced the correction of the reference 
dose (RfD) appearing on page 24836, column three, third full paragraph, 
line 11, from ``0.0002,'' to ``0.002.'' Because of a then-existing data 
gap, all initial tolerances were time-limited. The time limitation was 
established to provide sufficient time for the development and review 
of additional data, specifically a rat 2-generation reproduction study. 
Abbott Laboratories submitted such a study on September 27, 1999. The 
Agency had also not completed its assessment of new internationally-
generated apple residue data (submitted by Valent BioSciences 
Corporation on May 23, 2000), and of supplementary data received before 
and after the publication of the July 12, 2001 rule.
    Pursuant to section 408(d)(2)(A)(i) of the FFDCA, as amended, 
Abbott Laboratories submitted a summary of information, data, and 
arguments in support of their pesticide petition, which was published 
in the Federal Register of February 20, 1997 (62 FR 7778) (FRL- 5589-
4). EPA has not republished the summary of information initially 
submitted by Abbott Laboratories and published in the Federal Register 
of February 20, 1997 except where EPA believes such information would 
be helpful in understanding the new data. Valent BioSciences 
Corporation is, however, relying on the previously submitted 
information in addition to the new data summarized below in support of 
this pesticide petition to establish permanent tolerances. EPA will 
take into account all available data when giving due consideration to 
Valent BioSciences Corporation's petition. 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. 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.

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 and pears. 
Applied once a season at 4 weeks prior to the anticipated beginning of 
the normal harvest period, it is used at the rate of 50 grams active 
ingredient per acre.

B. Product Identity/Chemistry

    1. Identity of the pesticide and corresponding residues. Astudy 
designed to determine whether uptake, translocation and metabolism of 
amino-ethoxyvinylglycine hydrochloride occurs in apples identified 
seven minor metabolites in addition to the primary metabolite, N-
acetylaminoethoxyvinylglycine. The study was not meant as a measure of 
the amount of N-acetylaminoethoxyvinylglycine 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-acetylaminoethoxyvinylglycine and several other 
minor metabolites, and is partially degraded on the apple surface

[[Page 64346]]

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 and harvested at the specified minimum treatment to harvest 
intervals. Residue data 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 residue data generated internationally 
has been provided to EPA by Valent BioSciences Corporation. There is a 
practical method for detecting and measuring levels of aviglycine HCl 
in or on food with a limit of detection (LOD) that allows monitoring of 
food 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 HCl 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 
residue studies has been validated by an independent laboratory and 
provided to FDA. The limit of quantitation (LOQ) was 0.075 [mu]g/kg.
    3. A statement of why an analytical method for detecting and 
measuring the levels of the pesticide residue are not needed. 
Analytical Enforcement Methodology. Adequate enforcement methodology 
high performance liquid chromotography (HPLC)/fluorescence detector) is 
available to enforce the tolerance expression. The method may be 
requested from: Christine Olinger, Acting Chief of the Analytical 
Chemistry Branch, Environmental Science Center, 701 Mapes Rd., Fort 
Meade, MD 20755-5350; telephone number: (410) 305-2905; e-mail address: 
[email protected].

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 at a higher dose level. 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 at the 2.5 mg a.i./kg bwt/
day dose, 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 vaculation is considered an adaptive change. Increased 
vaculation 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, 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 to active ingredient 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, and 
processed apples and pears. Chronic dietary exposure assessments were 
conducted using a Tier I approach. This Tier I assessment incorporated 
tolerance level residues and 100% crop-treated in the estimated dietary 
intake trends. The resulting exposures were compared to a RfD of 0.007 
mg a.i./kg bwt/day, which was based on the NOAEL of 0.7 mg a.i./kg bwt/
day from the 104-week rat study and a 100-fold uncertainty factor (UF). 
Chronic dietary exposure estimates for the overall U.S. population and 
25 population subgroups are well below the chronic RfD. There are no 
acute toxicity concerns with aviglycine HCl as there is no 
toxicological endpoint attributable to a single exposure in the 
aviglycine HCl toxicology data base,

[[Page 64347]]

including the rat and rabbit developmental studies. Therefore, only 
chronic dietary exposures have been assessed.
    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.
    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 alpha 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 0.98% 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 was calculated to be 10.3% of the RfD. The 
proposed tolerances will utilize 0.98% 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               0.170               December 21, 2003
------------------------------------------------------------------------

I. International Tolerances

    There are no codex maximum residue limits for use of 
aminoethoxyvinylglycine hydrochloride on apples or pears, or on any 
other crop.
[FR Doc. 03-28425 Filed 11-12-03; 8:45 am]
BILLING CODE 6560-50-S