Aminoethoxyvinylglycine hydrochloride (Aviglycine HCI); Notice of Filing a Pesticide Petition to Establish a Tolerance for a Certain Pesticide Chemical in or on Food, 23162-23167 [05-8791]
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Federal Register / Vol. 70, No. 85 / Wednesday, May 4, 2005 / Notices
V. Procedures for Withdrawal of
Request
Registrants who choose to withdraw a
request for cancellation must submit
such withdrawal in writing to the
person listed under FOR
FURTHERINFORMATION CONTACT,
postmarked before June 3, 2005. This
written withdrawal of the request for
cancellation will apply only to the
applicable FIFRA section 6(f)(1) request
listed in this notice. If the products have
been subject to a previous cancellation
action, the effective date of cancellation
and all other provisions of any earlier
cancellation action are controlling.
VI. Provisions for Disposition of
Existing Stocks
Upon the close of the comment period
for this Notice, EPA expects to issue an
order granting the requests for voluntary
cancellation and amendments for the
products identified in Tables 1 and 2,
and to include in the order provisions
regarding the status of existing stocks of
the pesticides. Existing stocks are
defined in EPA’s existing stocks policy
(56 FR 29362, June 26, 1991) as those
stocks of registered pesticide products
which are currently in the United States
and which were packaged, labeled, and
released for shipment prior to the
effective date of the cancellation or
amendment of their registration. Any
distribution, sale, or use of existing
stocks, except as provided in the
amendment or cancellation order,
would be considered a violation of
section 12(a)(2)(K) and/or 12(a)(1)(A) of
FIFRA.
In any order issued in response to
these requests for cancellation or
amendment to terminate certain uses,
EPA proposes to include the following
provisions for the treatment of any
existing stocks of the products
identified or referenced in Table 1 or 2:
1. Distribution or sale of products by
the registrant labeled for use on apples,
broccoli raab, cabbage, collards, fennel,
grapes, head lettuce, lespedeza,
spinach, tomatillo, and trefoil:
The registrant of any product listed in
Table 1 or 2 may distribute or sell
existing stocks of the product bearing
labels for use on apples, broccoli, raab,
cabbage, collards, fennel, grapes, head
lettuce, lespedeza, spinach, tomatillo, or
trefoil for 1 year after the effective date
of the cancellation or amendment order.
The distribution or sale of existing
stocks by the registrant of any product
listed in Table 1 or 2 will not be lawful
under FIFRA 1 year after the effective
date of the cancellation or amendment
order, except for the purposes of
shipping such stocks for export
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consistent with section 17 of FIFRA or
for proper disposal.
2. Distribution, sale, or use of
products by persons other than the
registrant labeled for use on apples,
broccoli raab, cabbage, collards, fennel,
grapes, head lettuce, lespedeza,
spinach, tomatillo, and trefoil:
Any person other than the registrant
may distribute, sell, and use existing
stocks of any product listed in Table 1
or 2 that is labeled for use on apples,
broccoli raab, cabbage, collards, fennel,
grapes, head lettuce, lespedeza, spinach,
tomatillo, and trefoil after the effective
date of the cancellation or amendment
order and until such existing stocks are
exhausted.
List of Subjects
Environmental protection, Pesticides
and Pests.
Dated: April 26, 2005.
Debra Edwards,
Director, Special Review and Reregistration
Division, Office of Pesticide Programs.
[FR Doc. 05–8865 Filed 5–3–05; 8:45 am]
BILLING CODE 6560–50–S
ENVIRONMENTAL PROTECTION
AGENCY
[OPP–2005–0111; FRL–7710–6]
Aminoethoxyvinylglycine
hydrochloride (Aviglycine HCI); Notice
of Filing a Pesticide Petition to
Establish a Tolerance for a Certain
Pesticide Chemical in or on Food
Environmental Protection
Agency (EPA).
ACTION: Notice.
AGENCY:
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–2005–
0111, must be received on or before June
3, 2005.
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:
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(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:
• Crop production (NAICS 111)
• Animal production (NAICS 112)
• Food manufacturing (NAICS 311)
• 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 identification (ID) number
OPP–2005–0111. 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, 1801 S. Bell St.,
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
https://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
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Dockets at https://www.epa.gov/edocket/
to submit or view public comments,
access the index listing of the contents
of the official public docket, and to
access those documents in the public
docket that are available electronically.
Although not all docket materials may
be available electronically, you may still
access any of the publicly available
docket materials through the docket
facility identified in Unit I.B.1. Once in
the system, select ‘‘search,’’ then key in
the appropriate docket ID number.
Certain types of information will not
be placed in the EPA Dockets.
Information claimed as CBI and other
information whose disclosure is
restricted by statute, which is not
included in the official public docket,
will not be available for public viewing
in EPA’s electronic public docket. EPA’s
policy is that copyrighted material will
not be placed in EPA’s electronic public
docket but will be available only in
printed, paper form in the official public
docket. To the extent feasible, publicly
available docket materials will be made
available in EPA’s electronic public
docket. When a document is selected
from the index list in EPA Dockets, the
system will identify whether the
document is available for viewing in
EPA’s electronic public docket.
Although not all docket materials may
be available electronically, you may still
access any of the publicly available
docket materials through the docket
facility identified in Unit I.B.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
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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 email 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 https://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–2005–0111. 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.
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ii. E-mail. Comments may be sent by
e-mail to opp-docket@epa.gov,
Attention: Docket ID number OPP–
2005–0111. 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 –2005–0111.
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, 1801 S. Bell St.,
Arlington, VA, Attention: Docket ID
number OPP–2005–0111. 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
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not contain CBI on disk or CD ROM,
mark the outside of the disk or CD ROM
clearly that it does not contain CBI.
Information not marked as CBI will be
included in the public docket and EPA’s
electronic public docket without prior
notice. If you have any questions about
CBI or the procedures for claiming CBI,
please consult the person listed under
FOR FURTHER INFORMATION CONTACT.
E. What Should I Consider as I Prepare
My Comments for EPA?
You may find the following
suggestions helpful for preparing your
comments:
1. Explain your views as clearly as
possible.
2. Describe any assumptions that you
used.
3. Provide copies of any technical
information and/or data you used that
support your views.
4. If you estimate potential burden or
costs, explain how you arrived at the
estimate that you provide.
5. Provide specific examples to
illustrate your concerns.
6. Make sure to submit your
comments by the deadline in this
notice.
7. To ensure proper receipt by EPA,
be sure to identify the docket ID number
assigned to this action in the subject
line on the first page of your response.
You may also provide the name, date,
and Federal Register citation.
II. What Action is the Agency Taking?
EPA has received a pesticide petition
as follows proposing the establishment
and/or amendment of regulations for
residues of a certain pesticide chemical
in or on various food commodities
under section 408 of the Federal Food,
Drug, and Cosmetic Act (FFDCA), 21
U.S.C. 346a. EPA has determined that
this petition contains data or
information regarding the elements set
forth in FFDCA section 408(d)(2);
however, EPA has not fully evaluated
the sufficiency of the submitted data at
this time or whether the data support
granting of the petition. Additional data
may be needed before EPA rules on the
petition.
List of Subjects
Environmental protection,
Agricultural commodities, Feed
additives, Food additives, Pesticides
and pests, Reporting and recordkeeping
requirements.
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Dated: April 18, 2005.
Janet L. Anderson,
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 Corp.
PP 6F4632
EPA has received a pesticide petition
6F4632 from Valent BioSciences
Corp.,870 Technology Way, Libertyville,
Il. 60048, proposing pursuant to section
408(d) of the Federal Food, Drug, and
Cosmetic Act (FFDCA), 21 U.S.C.
346a(d), to amend 40 CFR part 180 to
establish an exemption from the
requirement of a tolerance for the
biochemical pesticide
Aminoethoxyvinylglycine
hydrochloride (Aviglycine HCI or AVG)
in or on walnut and cucumber.
Pursuant to section 408(d)(2)(A)(i) of
the FFDCA, as amended, Valent
BioSciences Corp. has submitted the
following summary of information, data,
and arguments in support of their
pesticide petition. This summary was
prepared by Valent BioSciences Corp.
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
Aviglycine HCl (AVG) is a plant
growth regulator used in preventing
pistillate flower abortion (PFA) in
walnuts, thereby increasing yield. AVG
is the active ingredient (ai) in ReTain
Plant Growth Regulator (EPA Reg.
73049–45) and ReTain Plant Growth
Regulator for California (EPA Reg. No.
73049–58). The proposed use is for a
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single application to orchards when 5 to
10% of each of the trees is in bloom in
order to increase the fruit set in walnut
cultivars that suffer a high incidence of
PFA. The proposed use rate for walnuts
is 50 - 100 grams a.i./acre (0.73 - 1.46
lbs of ReTain per acre targeting 125
parts per million (ppm) AVG in the
spray solution) in a spray volume of 100
gallons per acre for small trees, 200
gallons per acre for large trees.
Aviglycine HCl is a plant growth
regulator effective in inducing staminate
(male) flowers on gynoecious (all
female) breeding lines of curcubits used
in seed production. AVG is the ai in
ReTain Plant Growth Regulator (EPA
Reg. 73049–45) and ReTain Plant
Growth Regulator for California (EPA
Reg. No. 73049–58). The proposed use
is for one to four applications of ReTain
to cucumber plants at early first leaf
stage through to the tenth leaf stage. The
proposed use rate for cucumbers is 19
to 48 grams a.i./acre (0.28 - 0.7 lbs of
ReTain per acre targeting 250 to 500
ppm AVG in the spray solution) in a
spray volume of 10 to 25 gallons per
acre to ensure good coverage.
B. Product Identity/Chemistry
1. Identity of the pesticide and
corresponding residues. A study
designed to determine whether uptake,
translocation and metabolism of AVG
occurs in apples identified seven minor
metabolites in addition to the primary
metabolite, N-acetyl aviglycine HCl. The
study was not meant as a measure of the
amount of AVG residues and
metabolites found in apples under
normal field conditions. The only
significant incorporation of AVG in
apple tissues, following brush-on
application at high rates, resulted from
absorption from the peel rather than
translocation from the leaves. AVG is
also metabolized in the tissues to form
N-acetyl aviglycine HCl and several
other minor metabolites, and is partially
degraded on the apple surface to watersoluble 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. It is improbable that the
proposed early season use of aviglycine
HCl, as a means of preventing PFA,
would result in measurable residues in
the meat of walnuts. The proposed
timing of application to walnut trees is
early to mid-bloom. The use precludes
direct applications to walnut fruit
which are not yet present on the trees
and are harvested 3–5 months after
application. The edible portion of the
nut is further protected by the hull and
shell surrounding the nut. Translocation
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of aviglycine HCl residues within
treated plants was examined in studies
of AVG metabolism in apple trees.
There is minimal translocation of
aviglycine HCl within plants. Residues
of AVG will degrade over time on and
in treated plant tissue. As a result, the
potential for measurable residues of
aviglycine HCl on the harvested edible
portion of walnuts following application
of ReTain to control PFA in walnuts is
negligible.
The proposed use of aviglycine HCl
on cucumbers is for seed production
only. The proposed use is for an early
season application to immature plants.
There is minimal translocation of
aviglycine HCl within plants. Residues
of AVG will degrade over time on and
in treated plant tissue. Therefore it is
unlikely residual AVG will be present in
the fruit or seed at the time the seed is
harvested. There are also two
generations between the seed
production use of ReTain and
generation of a commercial edible plant
product from that seed. Curcubit seed is
mechanically harvested with
specialized equipment that destroys the
fruit to obtain the seed. As a result, the
potential for measurable residues of
aviglycine HCl on the harvested edible
portion of commercially grown
cucumbers following application of
ReTain as a means of inducing male
flowers in seed production 2–
generations before commercial harvest
is negligible. Analytical methods for the
detection of aviglycine HCl have been
submitted to EPA in support of petitions
for tolerances on pome and stone fruit.
An analytical method for detection of
aviglycine HCl residues in or on
walnuts or cucumbers is not required.
There is negligible potential for
measurable residues of aviglycine HCl
on walnuts or cucumbers as a result of
the proposed use of ReTain and an
exemption from the requirements of a
tolerance for both walnuts and
cucumbers is being sought.
3. A statement of why an analytical
method for detecting and measuring the
levels of the pesticide residue are not
needed. An analytical method for
detection of aviglycine HCl residues in
walnuts or cucumbers is not required.
The proposed uses of aviglycine HCl on
walnuts is for a single season
application of ReTain at a rate of 50 to
100 g a.i./acre, applied to walnut trees
early to mid-bloom to control pistillate
flower abortion. It is highly unlikely
that this early season application at low
rates would result in measurable
residues in the harvested meat of
walnuts. Therefore, it should not be
necessary to establish a tolerance for
this use. Residue studies, methods
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supporting the analysis and methods of
analysis for purpose of enforcement
would similarly not be required.
The proposed use of aviglycine HCl is
one to four early season applications of
ReTain to breeding lines of cucumbers
for seed production. ReTain is not
proposed for use on cucumbers destined
for commercial harvest and it is highly
unlikely that application to cucumbers
grown for seed production could or
would result in measurable residues in
the cucumbers grown commercially
from progeny of that seed. Therefore, it
should not be necessary to establish a
tolerance for this use. Residue studies,
methods supporting the analysis and
methods of analysis for purpose of
enforcement would similarly not be
required.
C. Mammalian Toxicological Profile
1. Acute toxicity. Aviglycine HCl has
low acute oral, dermal, and inhalation
toxicity. The oral lethal dose (LD50) in
rats is >5,000 milligrams/kilogram (mg/
kg), the dermal LD50 is >2,000 mg/kg
and the inhalation 4-hour lethal
concentration (LC50) is >5.00
milligrams/Liter (mg/L) air. AVG is not
a skin sensitizer in guinea pigs, and is
not irritating to the skin and eyes of
rabbits. End-use formulations of AVG
have similar low acute toxicity profiles.
2. Genotoxicity. AVG 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 AVG, there was no
evidence of teratogenicity or other
embryotoxic effects at the highest dose
levels, although maternal toxicity was
evident. The rabbit maternal no
obvserved adverse effect level (NOAEL)
was established at 0.4 mg a.i./kg/day
based on reduced body weight gains and
food consumption, and decreased
defecation. Developmental NOAEL was
established at 0.4 mg a.i./kg/day based
on fetal body weights. In the rat test the
maternal NOAEL was established at
1.77 mg a.i./kg/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/
day based on decreased mean fetal body
weights and reduced ossification. The
developmental and maternal LOELs
were established at 8.06 mg/kg/day.
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AVG was evaluated in a rat 2generation 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/day. The NOAEL for
reproductive toxicity was established at
4.0 mg a.i./kg/day and the neonatal
toxicity NOAEL was established at 2.5
mg a.i./kg/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/day for males and femalesbased 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/day.
For dogs, the NOAEL was established at
0.6 mg a.i./kg/day based on
inappetence, low body weight gain and
centrilobular histopathological changes
in the liver at 1.2 mg a.i./kg/day.
A 21 day repeat dose dermal toxicity
study in rats was carried out at 0, 100,
500, and 1,000 mg/kg/day. The no
observed effect level (NOEL) is 1,000
mg/kg/day; a lowest observed effect
level (LOEL) was not determined.
5. Chronic toxicity. Chronic studies
with AVG 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/kg/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 AVG
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 AVG at 7 mg a.i/kg/
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/
kg/day.
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D. Aggregate Exposure
1. Dietary exposure—i. Food. There is
no expected dietary exposure to
residues of aviglycine HCl from the
proposed early to mid-bloom use of
ReTain on walnuts. No residues are
expected on the commodity.
Additionally, the contribution of
walnuts as a percent of total diet is
relatively small. It is estimated that
walnuts contribute 0.009% of the diet of
the general population and 0.005% to
the diet of non-nursing infants. There is
no expected dietary exposure to
residues of aviglycine HCl from the
proposed use of ReTain on cucumbers
for seed production. No residues are
expected on any cucumbers produced
for consumption from the proposed use.
Expected dietary exposures from
residues of AVG would occur through
apples, pears, peaches, nectarines,
plums, processed pome, and stone-fruits
(excluding cherries). 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 (CT)
for all crops, default processing factors
and consumption data from the 1994
through 1998 United States Department
of Agriculture (USDA) Continuing
Surveys of Food Intakes by Individuals
(CSFII 1994, 1995, 1996, and 1998).
Estimates of chronic and acute dietary
exposure were calculated using Dietary
Exposure Evaluation Module Food
Commodity Intake Database (DEEMTMFCIDTM) software (Novigen, 2001). The
database was used to determine chronic
exposure estimates for the overall U.S.
population and 24 population
subgroups and acute exposure estimates
for the overall U.S. population and 10
population subgroups.
The resulting exposures were
compared to a chronic reference dose
(RfD) of 0.007 mg a.i./kg/day and an
acute NOEL of 1.77 mg/kg bwt/day. The
RfD is based on the NOAEL of 0.7 mg
a.i./kg/day from the rat chronic toxicity
study (52 week) and the rat
carcinogenicity feeding study (104–
week) with a 100-fold uncertainty factor
to account for intra-species and interspecies variations. The acute NOEL 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% CT
assumption for all crops were 15.9% of
the RfD or less for all populations
examined. Acute dietary exposure was
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estimated for the overall U.S.
population and the population
subgroups: (i) all infants, (ii) nursing
infants, (iii) non-nursing infants, (iv)
children 1 to 2 years of age, (viii) adults
20 to 49 years of age, (ix) females 13 to
49 years of age and (x) adults 50 years
and older. Estimated daily exposures
from tolerance level residues (at the 95th
percentile) and a 100% CT assumption
for all crops resulted in MOEs (Margin
of Exposure) greater than 430 for all
population groups examined.
The proposed agricultural uses of
aviglycine HCl will not alter the results
of the chronic and acute dietary
exposure analyses conducted for pome
fruit and stone fruit applications, which
clearly demonstrated a reasonable
certainty that no harm will result from
the agricultural uses of AVG.
ii. Drinking water. AVG is highly
unlikely to contaminate groundwater
resources due to its high soil sorption,
and short soil and water/sediment halflives. Study results show that AVG is
easily adsorbed to soils, principally onto
clay particles. Half-lives in soils vary
between 0.6 and 4.3 days. Watersediment studies have shown that AVG
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 AVG in
the aqueous phase and total water/
sediment system was calculated to be
approximately 1.2 and 2.3 days
respectively. An AVG water
concentration assessment was
conducted using the EPA first Tier
screening models. FIRST was used for
surfacewater concentration assessment
and forscreening concentration in
groundwater, SCI-GROW was used for
groundwater assessment. There were no
estimated groundwater concentrations
according to SCI-GROW. Peak
surfacewater concentrations estimated
using FIRST were 1.283 and the
estimated annual average was 0.021
parts per billion (ppb), assuming 87%
CT. The contribution of drinking water
to aggregate risk is considered to be
negligible.
2. Non-dietary exposure. AVG has no
product registrations for residential nonfood uses. Non-occupational, nondietary exposure for AVG 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
milligrams/kilogram/day (mg/kg/day),
the highest dose tested (HDT).
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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 AVG
would be cumulative with those of any
other chemical compounds. AVG has a
novel mode of action compared to other
currently registered active ingredients.
Therefore, Valent BioSciences Corp.
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. The proposed use of
aviglycine HCL on walnuts prior to fruit
development is not expected to result in
measurable residues on the walnuts
harvested for consumption
approximately 4 months following
application. Using the chronic exposure
assumptions for pome and stone fruit
and the proposed RfD described above,
the dietary exposure to AVG 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
AVG in food and drinking water will
not result in unacceptable levels of
human health risk.
2. Infants and children. FFDCA
section 407 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 database.
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 database is complete.
There is no indication of increased
sensitivity in the database overall, and
specifically, there is no indication of
increased sensitivity in the
developmental and multi-generation
reproductive toxicity studies. Therefore,
Valent BioSciences Corp. 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
AVG for non-nursing infants, the most
highly exposed population subgroup,
was calculated to be 0.001110 mg/kg
bwt/day or 15.9% of the reference dose.
Daily exposure for the overall U.S.
population was estimated to be
0.000153 mg/kg bwt/day. The proposed
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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/kg/day with a NOAEL of
5 mg/kg/day based on decreased
primary antibody (igM) response to
sheep red blood cells; decreased
absolute and relative thymus weights;
decreased body weight, food
consumption and food efficiency at the
high dose level. The LOEL is 15 mg/kg/
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 AVG is considered negligible.
H. Existing Tolerances
Tolerances have been established for
the residues of AVG in or on the
following food commodities:
Commodity
Parts per million
Apples
0.08
Fruit, stone, group 12, (except cherry)
0.170
Pears
0.08
I. International Tolerances
There are no Codex maximum residue
limits for use of aviglycine HCl on
apples or pears, or on any other crop.
[FR Doc. 05–8791 Filed 5–3–05; 8:45 am]
number: (202) 564–9364; e-mail address:
underdown.adella@epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information
Environmental Protection
Agency (EPA).
ACTION: Notice.
A. Does this Action Apply to Me?
This action is directed in particular to
the chemical manufacturer and/or
importer who submitted the TME to
EPA. This action may, however, be of
interest to the public in general. Since
other entities may also be interested, the
Agency has not attempted to describe all
the specific entities that may be affected
by this action. If you have any questions
regarding the applicability of this action
to a particular entity, consult the
technical person listed under FOR
FURTHER INFORMATION CONTACT.
This notice announces EPA’s
approval of an application for test
marketing exemption (TME) under
section 5(h)(1) of the Toxic Substances
Control Act (TSCA) and 40 CFR 720.38.
EPA has designated this application as
TME–05–3. The test marketing
conditions are described in the TME
application and in this notice.
DATES: Approval of this TME is effective
April 27, 2005.
FOR FURTHER INFORMATION CONTACT: For
general information contact: Colby
Lintner, Regulatory Coordinator,
Environmental Assistance Division
(7408M), Office of Pollution Prevention
and Toxics, Environmental Protection
Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460–0001; telephone
number: (202) 554–1404; e-mail address:
TSCA-Hotline@epa.gov.
For technical information contact:
Adella Underdown, Program Manager,
Chemical Control Division (7405M),
Office of Pollution Prevention and
Toxics, Environmental Protection
Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460–0001; telephone
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 identification (ID) number
OPPT–2005–0026. 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
EPA Docket Center, Rm. B102-Reading
Room, EPA West, 1301 Constitution
Ave., NW., Washington, DC. The EPA
Docket Center is open from 8:30 a.m. to
4:30 p.m., Monday through Friday,
excluding legal holidays. The EPA
Docket Center Reading Room telephone
number is (202) 566–1744 and the
telephone number for the OPPT Docket,
which is located in EPA Docket Center,
is (202) 566–0280.
BILLING CODE 6560–50–S
ENVIRONMENTAL PROTECTION
AGENCY
[OPPT–2005–0026; FRL–7713–6]
Approval of Test Marketing Exemption
for a Certain New Chemical
AGENCY:
SUMMARY:
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2. Electronic access. You may access
this Federal Register document
electronically through the EPA Internet
under the ‘‘Federal Register’’ listings at
https://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 https://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.
II. What is the Agency’s Authority for
Taking this Action?
Section 5(h)(1) of TSCA and 40 CFR
720.38 authorizes EPA to exempt
persons from premanufacture
notification (PMN) requirements and
permit them to manufacture or import
new chemical substances for test
marketing purposes, if the Agency finds
that the manufacture, processing,
distribution in commerce, use, and
disposal of the substances for test
marketing purposes will not present an
unreasonable risk of injury to health or
the environment. EPA may impose
restrictions on test marketing activities
and may modify or revoke a test
marketing exemption upon receipt of
new information which casts significant
doubt on its finding that the test
marketing activity will not present an
unreasonable risk of injury.
III. What Action is the Agency Taking?
EPA approves the above-referenced
TME. EPA has determined that test
E:\FR\FM\04MYN1.SGM
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]]>Agencies
[Federal Register Volume 70, Number 85 (Wednesday, May 4, 2005)]
[Notices]
[Pages 23162-23167]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-8791]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
[OPP-2005-0111; FRL-7710-6]
Aminoethoxyvinylglycine hydrochloride (Aviglycine HCI); 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-
2005-0111, must be received on or before June 3, 2005.
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:
Crop production (NAICS 111)
Animal production (NAICS 112)
Food manufacturing (NAICS 311)
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 identification (ID) number OPP-2005-0111. 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,
1801 S. Bell St., 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 https://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
[[Page 23163]]
Dockets at https://www.epa.gov/edocket/ to submit or view public
comments, access the index listing of the contents of the official
public docket, and to access those documents in the public docket that
are available electronically. Although not all docket materials may be
available electronically, you may still access any of the publicly
available docket materials through the docket facility identified in
Unit I.B.1. Once in the system, select ``search,'' then key in the
appropriate docket ID number.
Certain types of information will not be placed in the EPA Dockets.
Information claimed as CBI and other information whose disclosure is
restricted by statute, which is not included in the official public
docket, will not be available for public viewing in EPA's electronic
public docket. EPA's policy is that copyrighted material will not be
placed in EPA's electronic public docket but will be available only in
printed, paper form in the official public docket. To the extent
feasible, publicly available docket materials will be made available in
EPA's electronic public docket. When a document is selected from the
index list in EPA Dockets, the system will identify whether the
document is available for viewing in EPA's electronic public docket.
Although not all docket materials may be available electronically, you
may still access any of the publicly available docket materials through
the docket facility identified in Unit I.B.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 https://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-2005-0111. 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-2005-0111. 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 -2005-0111.
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, 1801 S. Bell St., Arlington, VA, Attention: Docket ID
number OPP-2005-0111. 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
[[Page 23164]]
not contain CBI on disk or CD ROM, mark the outside of the disk or CD
ROM clearly that it does not contain CBI. Information not marked as CBI
will be included in the public docket and EPA's electronic public
docket without prior notice. If you have any questions about CBI or the
procedures for claiming CBI, please consult the person listed under FOR
FURTHER INFORMATION CONTACT.
E. What Should I Consider as I Prepare My Comments for EPA?
You may find the following suggestions helpful for preparing your
comments:
1. Explain your views as clearly as possible.
2. Describe any assumptions that you used.
3. Provide copies of any technical information and/or data you used
that support your views.
4. If you estimate potential burden or costs, explain how you
arrived at the estimate that you provide.
5. Provide specific examples to illustrate your concerns.
6. Make sure to submit your comments by the deadline in this
notice.
7. To ensure proper receipt by EPA, be sure to identify the docket
ID number assigned to this action in the subject line on the first page
of your response. You may also provide the name, date, and Federal
Register citation.
II. What Action is the Agency Taking?
EPA has received a pesticide petition as follows proposing the
establishment and/or amendment of regulations for residues of a certain
pesticide chemical in or on various food commodities under section 408
of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a.
EPA has determined that this petition contains data or information
regarding the elements set forth in FFDCA section 408(d)(2); however,
EPA has not fully evaluated the sufficiency of the submitted data at
this time or whether the data support granting of the petition.
Additional data may be needed before EPA rules on the petition.
List of Subjects
Environmental protection, Agricultural commodities, Feed additives,
Food additives, Pesticides and pests, Reporting and recordkeeping
requirements.
Dated: April 18, 2005.
Janet L. Anderson,
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 Corp.
PP 6F4632
EPA has received a pesticide petition 6F4632 from Valent
BioSciences Corp.,870 Technology Way, Libertyville, Il. 60048,
proposing pursuant to section 408(d) of the Federal Food, Drug, and
Cosmetic Act (FFDCA), 21 U.S.C. 346a(d), to amend 40 CFR part 180 to
establish an exemption from the requirement of a tolerance for the
biochemical pesticide Aminoethoxyvinylglycine hydrochloride (Aviglycine
HCI or AVG) in or on walnut and cucumber.
Pursuant to section 408(d)(2)(A)(i) of the FFDCA, as amended,
Valent BioSciences Corp. has submitted the following summary of
information, data, and arguments in support of their pesticide
petition. This summary was prepared by Valent BioSciences Corp. 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
Aviglycine HCl (AVG) is a plant growth regulator used in preventing
pistillate flower abortion (PFA) in walnuts, thereby increasing yield.
AVG is the active ingredient (ai) in ReTain Plant Growth Regulator (EPA
Reg. 73049-45) and ReTain Plant Growth Regulator for California (EPA
Reg. No. 73049-58). The proposed use is for a single application to
orchards when 5 to 10% of each of the trees is in bloom in order to
increase the fruit set in walnut cultivars that suffer a high incidence
of PFA. The proposed use rate for walnuts is 50 - 100 grams a.i./acre
(0.73 - 1.46 lbs of ReTain[reg] per acre targeting 125 parts per
million (ppm) AVG in the spray solution) in a spray volume of 100
gallons per acre for small trees, 200 gallons per acre for large trees.
Aviglycine HCl is a plant growth regulator effective in inducing
staminate (male) flowers on gynoecious (all female) breeding lines of
curcubits used in seed production. AVG is the ai in ReTain Plant Growth
Regulator (EPA Reg. 73049-45) and ReTain Plant Growth Regulator for
California (EPA Reg. No. 73049-58). The proposed use is for one to four
applications of ReTain to cucumber plants at early first leaf stage
through to the tenth leaf stage. The proposed use rate for cucumbers is
19 to 48 grams a.i./acre (0.28 - 0.7 lbs of ReTain[reg] per acre
targeting 250 to 500 ppm AVG in the spray solution) in a spray volume
of 10 to 25 gallons per acre to ensure good coverage.
B. Product Identity/Chemistry
1. Identity of the pesticide and corresponding residues. A study
designed to determine whether uptake, translocation and metabolism of
AVG occurs in apples identified seven minor metabolites in addition to
the primary metabolite, N-acetyl aviglycine HCl. The study was not
meant as a measure of the amount of AVG residues and metabolites found
in apples under normal field conditions. The only significant
incorporation of AVG in apple tissues, following brush-on application
at high rates, resulted from absorption from the peel rather than
translocation from the leaves. AVG is also metabolized in the tissues
to form N-acetyl aviglycine HCl 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. It is improbable that the proposed early season
use of aviglycine HCl, as a means of preventing PFA, would result in
measurable residues in the meat of walnuts. The proposed timing of
application to walnut trees is early to mid-bloom. The use precludes
direct applications to walnut fruit which are not yet present on the
trees and are harvested 3-5 months after application. The edible
portion of the nut is further protected by the hull and shell
surrounding the nut. Translocation
[[Page 23165]]
of aviglycine HCl residues within treated plants was examined in
studies of AVG metabolism in apple trees. There is minimal
translocation of aviglycine HCl within plants. Residues of AVG will
degrade over time on and in treated plant tissue. As a result, the
potential for measurable residues of aviglycine HCl on the harvested
edible portion of walnuts following application of ReTain to control
PFA in walnuts is negligible.
The proposed use of aviglycine HCl on cucumbers is for seed
production only. The proposed use is for an early season application to
immature plants. There is minimal translocation of aviglycine HCl
within plants. Residues of AVG will degrade over time on and in treated
plant tissue. Therefore it is unlikely residual AVG will be present in
the fruit or seed at the time the seed is harvested. There are also two
generations between the seed production use of ReTain and generation of
a commercial edible plant product from that seed. Curcubit seed is
mechanically harvested with specialized equipment that destroys the
fruit to obtain the seed. As a result, the potential for measurable
residues of aviglycine HCl on the harvested edible portion of
commercially grown cucumbers following application of ReTain as a means
of inducing male flowers in seed production 2-generations before
commercial harvest is negligible. Analytical methods for the detection
of aviglycine HCl have been submitted to EPA in support of petitions
for tolerances on pome and stone fruit. An analytical method for
detection of aviglycine HCl residues in or on walnuts or cucumbers is
not required. There is negligible potential for measurable residues of
aviglycine HCl on walnuts or cucumbers as a result of the proposed use
of ReTain and an exemption from the requirements of a tolerance for
both walnuts and cucumbers is being sought.
3. A statement of why an analytical method for detecting and
measuring the levels of the pesticide residue are not needed. An
analytical method for detection of aviglycine HCl residues in walnuts
or cucumbers is not required. The proposed uses of aviglycine HCl on
walnuts is for a single season application of ReTain at a rate of 50 to
100 g a.i./acre, applied to walnut trees early to mid-bloom to control
pistillate flower abortion. It is highly unlikely that this early
season application at low rates would result in measurable residues in
the harvested meat of walnuts. Therefore, it should not be necessary to
establish a tolerance for this use. Residue studies, methods supporting
the analysis and methods of analysis for purpose of enforcement would
similarly not be required.
The proposed use of aviglycine HCl is one to four early season
applications of ReTain to breeding lines of cucumbers for seed
production. ReTain is not proposed for use on cucumbers destined for
commercial harvest and it is highly unlikely that application to
cucumbers grown for seed production could or would result in measurable
residues in the cucumbers grown commercially from progeny of that seed.
Therefore, it should not be necessary to establish a tolerance for this
use. Residue studies, methods supporting the analysis and methods of
analysis for purpose of enforcement would similarly not be required.
C. Mammalian Toxicological Profile
1. Acute toxicity. Aviglycine HCl has low acute oral, dermal, and
inhalation toxicity. The oral lethal dose (LD50) in rats is
>5,000 milligrams/kilogram (mg/kg), the dermal LD50 is
>2,000 mg/kg and the inhalation 4-hour lethal concentration
(LC50) is >5.00 milligrams/Liter (mg/L) air. AVG is not a
skin sensitizer in guinea pigs, and is not irritating to the skin and
eyes of rabbits. End-use formulations of AVG have similar low acute
toxicity profiles.
2. Genotoxicity. AVG 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 AVG, there was no evidence of
teratogenicity or other embryotoxic effects at the highest dose levels,
although maternal toxicity was evident. The rabbit maternal no
obvserved adverse effect level (NOAEL) was established at 0.4 mg a.i./
kg/day based on reduced body weight gains and food consumption, and
decreased defecation. Developmental NOAEL was established at 0.4 mg
a.i./kg/day based on fetal body weights. In the rat test the maternal
NOAEL was established at 1.77 mg a.i./kg/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/day based on decreased mean fetal body
weights and reduced ossification. The developmental and maternal LOELs
were established at 8.06 mg/kg/day.
AVG 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/day. The
NOAEL for reproductive toxicity was established at 4.0 mg a.i./kg/day
and the neonatal toxicity NOAEL was established at 2.5 mg a.i./kg/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/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/day. For
dogs, the NOAEL was established at 0.6 mg a.i./kg/day based on
inappetence, low body weight gain and centrilobular histopathological
changes in the liver at 1.2 mg a.i./kg/day.
A 21 day repeat dose dermal toxicity study in rats was carried out
at 0, 100, 500, and 1,000 mg/kg/day. The no observed effect level
(NOEL) is 1,000 mg/kg/day; a lowest observed effect level (LOEL) was
not determined.
5. Chronic toxicity. Chronic studies with AVG 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/kg/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 AVG 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 AVG at 7 mg a.i/kg/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/kg/day.
[[Page 23166]]
D. Aggregate Exposure
1. Dietary exposure--i. Food. There is no expected dietary exposure
to residues of aviglycine HCl from the proposed early to mid-bloom use
of ReTain on walnuts. No residues are expected on the commodity.
Additionally, the contribution of walnuts as a percent of total diet is
relatively small. It is estimated that walnuts contribute 0.009% of the
diet of the general population and 0.005% to the diet of non-nursing
infants. There is no expected dietary exposure to residues of
aviglycine HCl from the proposed use of ReTain on cucumbers for seed
production. No residues are expected on any cucumbers produced for
consumption from the proposed use. Expected dietary exposures from
residues of AVG would occur through apples, pears, peaches, nectarines,
plums, processed pome, and stone-fruits (excluding cherries). 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 (CT) for all
crops, default processing factors and consumption data from the 1994
through 1998 United States Department of Agriculture (USDA) Continuing
Surveys of Food Intakes by Individuals (CSFII 1994, 1995, 1996, and
1998). Estimates of chronic and acute dietary exposure were calculated
using Dietary Exposure Evaluation Module Food Commodity Intake Database
(DEEMTM-FCIDTM) software (Novigen, 2001). The
database was used to determine chronic exposure estimates for the
overall U.S. population and 24 population subgroups and acute exposure
estimates for the overall U.S. population and 10 population subgroups.
The resulting exposures were compared to a chronic reference dose
(RfD) of 0.007 mg a.i./kg/day and an acute NOEL of 1.77 mg/kg bwt/day.
The RfD is based on the NOAEL of 0.7 mg a.i./kg/day from the rat
chronic toxicity study (52 week) and the rat carcinogenicity feeding
study (104-week) with a 100-fold uncertainty factor to account for
intra-species and inter-species variations. The acute NOEL 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% CT 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:
(i) all infants, (ii) nursing infants, (iii) non-nursing infants, (iv)
children 1 to 2 years of age, (viii) adults 20 to 49 years of age, (ix)
females 13 to 49 years of age and (x) adults 50 years and older.
Estimated daily exposures from tolerance level residues (at the
95th percentile) and a 100% CT assumption for all crops
resulted in MOEs (Margin of Exposure) greater than 430 for all
population groups examined.
The proposed agricultural uses of aviglycine HCl will not alter the
results of the chronic and acute dietary exposure analyses conducted
for pome fruit and stone fruit applications, which clearly demonstrated
a reasonable certainty that no harm will result from the agricultural
uses of AVG.
ii. Drinking water. AVG is highly unlikely to contaminate
groundwater resources due to its high soil sorption, and short soil and
water/sediment half-lives. Study results show that AVG is easily
adsorbed to soils, principally onto clay particles. Half-lives in soils
vary between 0.6 and 4.3 days. Water-sediment studies have shown that
AVG 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 AVG in the aqueous phase and
total water/sediment system was calculated to be approximately 1.2 and
2.3 days respectively. An AVG water concentration assessment was
conducted using the EPA first Tier screening models. FIRST was used for
surfacewater concentration assessment and forscreening concentration in
groundwater, SCI-GROW was used for groundwater assessment. There were
no estimated groundwater concentrations according to SCI-GROW. Peak
surfacewater concentrations estimated using FIRST were 1.283 and the
estimated annual average was 0.021 parts per billion (ppb), assuming
87% CT. The contribution of drinking water to aggregate risk is
considered to be negligible.
2. Non-dietary exposure. AVG has no product registrations for
residential non-food uses. Non-occupational, non-dietary exposure for
AVG 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 milligrams/kilogram/day
(mg/kg/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 AVG
would be cumulative with those of any other chemical compounds. AVG has
a novel mode of action compared to other currently registered active
ingredients. Therefore, Valent BioSciences Corp. 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. The proposed
use of aviglycine HCL on walnuts prior to fruit development is not
expected to result in measurable residues on the walnuts harvested for
consumption approximately 4 months following application. Using the
chronic exposure assumptions for pome and stone fruit and the proposed
RfD described above, the dietary exposure to AVG 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 AVG in food and
drinking water will not result in unacceptable levels of human health
risk.
2. Infants and children. FFDCA section 407 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
database. 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
database is complete. There is no indication of increased sensitivity
in the database overall, and specifically, there is no indication of
increased sensitivity in the developmental and multi-generation
reproductive toxicity studies. Therefore, Valent BioSciences Corp.
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 AVG for non-nursing infants,
the most highly exposed population subgroup, was calculated to be
0.001110 mg/kg bwt/day or 15.9% of the reference dose. Daily exposure
for the overall U.S. population was estimated to be 0.000153 mg/kg bwt/
day. The proposed
[[Page 23167]]
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/kg/day with a NOAEL of 5 mg/kg/day based on
decreased primary antibody (igM) response to sheep red blood cells;
decreased absolute and relative thymus weights; decreased body weight,
food consumption and food efficiency at the high dose level. The LOEL
is 15 mg/kg/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 AVG is considered negligible.
H. Existing Tolerances
Tolerances have been established for the residues of AVG in or on
the following food commodities:
----------------------------------------------------------------------------------------------------------------
Commodity Parts per million
----------------------------------------------------------------------------------------------------------------
Apples 0.08
----------------------------------------------------------------------------------------------------------------
Fruit, stone, group 12, (except cherry) 0.170
----------------------------------------------------------------------------------------------------------------
Pears 0.08
----------------------------------------------------------------------------------------------------------------
I. International Tolerances
There are no Codex maximum residue limits for use of aviglycine HCl
on apples or pears, or on any other crop.
[FR Doc. 05-8791 Filed 5-3-05; 8:45 am]
BILLING CODE 6560-50-S
