[Federal Register: November 13, 2003 (Volume 68, Number 219)]
[Notices]
[Page 64343-64347]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr13no03-50]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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: greenway.denise@epa.gov.
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
[[Page 64344]]
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 opp-docket@epa.gov,
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.
[[Page 64345]]
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: residuemethods@epa.gov.
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