Fenarimol; Notice of Filing a Pesticide Petition to Establish a Tolerance for a Certain Pesticide Chemical in or on Food, 51802-51806 [05-17195]
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Federal Register / Vol. 70, No. 168 / Wednesday, August 31, 2005 / Notices
and risk from drinking water are well
within acceptable levels.
c. Cancer. The DWLOC for the cancer
risk assessment was calculated to be
0.12 ppb. Surface water and ground
water EECs of 0.052 ppb and 0.02 ppb,
respectively, were used for comparison
with the DWLOC. The EECs are below
the DWLOC, indicating that the cancer
risk would generally be considered
negligible.
2. Non-dietary exposure. Ethalfluralin
is not currently registered for use on any
residential non-food sites, and thus, it is
not expected that non-occupational,
non-dietary exposures will occur.
D. Cumulative Effects
EPA at this time has not established
methodologies to resolve the complex
issues concerning common mechanism
of toxicity in a meaningful way.
Although, ethalfluralin is a member of
the dinitroaniline class of herbicides,
there is no information available at this
time to determine whether ethalfluralin
has a common mechanism of toxicity
with other substances or how to include
this pesticide in a cumulative risk
assessment. Based on the metabolic
profile, the registrant concludes that
ethalfluralin does not appear to produce
a toxic metabolite produced by other
substances. Therefore, only aggregate
exposure and risk were considered.
E. Safety Determination
1. U.S. population. Using conservative
exposure assumptions previously
described, chronic dietary exposure to
residues of ethalfluralin from current
and proposed uses was estimated to
occupy only 0.2% of the RfD for the
general U.S. population. EPA generally
has no concern for exposures below
100% of the RfD since the RfD
represents the level at or below which
daily exposure over a lifetime will not
pose appreciable risks to human health.
Additionally, the chronic DWLOC was
found to be substantially greater than
EECs for ethalfluralin in surface water
or ground water, indicating risk is well
within acceptable levels. Cancer risk
resulting from potential exposure to
ethalfluralin through food and drinking
water was estimated. Cancer risk from
potential dietary and drinking water
exposure for the general U.S. population
was found to be within a range that EPA
has generally considered negligible.
Thus, based on the completeness and
reliability of the toxicity data and the
conservative exposure assessment, it is
concluded that, there is a reasonable
certainty that no harm will result to the
general U.S. population from aggregate
exposure to ethalfluralin residues from
current and proposed uses.
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16:33 Aug 30, 2005
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2. Infants and children. Risk for
developmental toxicity from acute
exposure to ethalfluralin was evaluated
for females 13+ years old. As indicated
in the previous discussion, risk from
aggregate acute exposure to ethalfluralin
through food and drinking water is well
within acceptable levels. It can be
concluded that there is a reasonable
certainty that no harm will result for
both females 13+ years old and for the
pre-natal development of infants from
aggregate acute exposure to
ethalfluralin.
Chronic aggregate exposure and risk
was evaluated for non-nursing infants,
the population subgroup predicted to be
most highly exposed. As indicated
previously, risk from aggregate chronic
exposure through food and drinking
water is well within acceptable levels.
Thus, based on the completeness and
reliability of the toxicity data and the
conservative exposure assessment, it
can be concluded with reasonable
certainty that no harm will result to
infants and children from chronic
aggregate exposure to ethalfluralin
based on current and proposed uses.
F. International Tolerances
There are no Codex, Canadian or
Mexican maximum residue limits
established for ethalfluralin.
[FR Doc. 05–17124 Filed 8–30–05; 8:45 am]
BILLING CODE 6560–50–S
ENVIRONMENTAL PROTECTION
AGENCY
[OPP–2005–0235; FRL–7733–1]
Fenarimol; 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–
0235, must be received on or before
September 30, 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.
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FOR FURTHER INFORMATION CONTACT:
Barbara Madden, Registration Division
(7505C), Office of Pesticide Programs,
Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington,
DC 20460–0001; telephone number:
(703) 305–6463; e-mail address:
madden.barbara@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 ID number OPP–2005–
0235. 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
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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.
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
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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 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–2005–0235. The
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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–
2005–0235. 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–2005–0235.
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–2005–0235. 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
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the comment that does not contain the
information claimed as CBI must be
submitted for inclusion in the public
docket and EPA’s electronic public
docket. If you submit the copy that does
not contain CBI on disk or CD ROM,
mark the outside of the disk or CD ROM
clearly that it does not contain CBI.
Information not marked as CBI will be
included in the public docket and EPA’s
electronic public docket without prior
notice. If you have any questions about
CBI or the procedures for claiming CBI,
please consult the person listed under
FOR FURTHER INFORMATION CONTACT.
E. What Should I Consider as I Prepare
My Comments for EPA?
You may find the following
suggestions helpful for preparing your
comments:
1. Explain your views as clearly as
possible.
2. Describe any assumptions that you
used.
3. Provide copies of any technical
information and/or data you used that
support your views.
4. If you estimate potential burden or
costs, explain how you arrived at the
estimate that you provide.
5. Provide specific examples to
illustrate your concerns.
6. Make sure to submit your
comments by the deadline in this
notice.
7. To ensure proper receipt by EPA,
be sure to identify the docket ID number
assigned to this action in the subject
line on the first page of your response.
You may also provide the name, date,
and Federal Register citation.
II. What Action is the Agency Taking?
EPA has received a pesticide petition
as follows proposing the establishment
and/or amendment of regulations for
residues of a certain pesticide chemical
in or on various food commodities
under section 408 of the Federal Food,
Drug, and Cosmetic Act (FFDCA), 21
U.S.C. 346a. EPA has determined that
this petition contains data or
information regarding the elements set
forth in FFDCA section 408(d)(2);
however, EPA has not fully evaluated
the sufficiency of the submitted data at
this time or whether the data support
granting of the petition. Additional data
may be needed before EPA rules on the
petition.
List of Subjects
Environmental protection,
Agricultural commodities, Feed
additives, Food additives, Pesticides
and pests, Reporting and recordkeeping
requirements.
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Dated: August 19, 2005.
Lois Rossi,
Director, Registration Division, Office of
Pesticide Programs.
Summary of Petition
The petitioner summary of the
pesticide petition is printed below as
required by FFDCA section 408(d)(3).
The summary of the petition was
prepared by the petitioner and
represents the view of the petitioner.
The petition summary announces the
availability of a description of the
analytical methods available to EPA for
the detection and measurement of the
pesticide chemical residues or an
explanation of why no such method is
needed.
Interregional Research Project Number
4
PP 5E4573
EPA has received a pesticide petition
(PP 5E4573) from Interregional Research
Project Number 4 (IR-4), 681 U.S.
Highway #1 South, North Brunswick, NJ
08902–3390 proposing, pursuant to
section 408(d) of the FFDCA, 21 U.S.C.
346a(d), to amend 40 CFR part 180 by
establishing a tolerance for residues of
fenarimol [alpha-(2-chlorophenyl)alpha-(4-chlorophenyl)-5pyrimidinemethanol] in or on the raw
agricultural commodity filbert at 0.02
parts per million (ppm). EPA has
determined that the petition contains
data or information regarding the
elements set forth in section 408(d)(2) of
the FFDCA; however, EPA has not fully
evaluated the sufficiency of the
submitted data at this time or whether
the data supports granting of the
petition. Additional data may be needed
before EPA rules on the petition.
A. Residue Chemistry
1. Plant metabolism. The nature of the
residue in fenarimol-treated filbert has
not been directly determined.
Radioactive metabolism studies with
apples and cherries indicate that
fenarimol is the only significant
component of the residue in apples and
cherries. The residue of concern in
filbert is fenarimol.
2. Analytical method. Analytical
methodology used for filbert is a slight
modification of the basic Pesticide
analytical manual (PAM II) method for
fenarimol (Method R039). Residues are
extracted with methanol. Aqueous
sodium chloride (5%) is added and the
extract is partitioned with
dichloromethane. Residues are cleaned
up on a Florisil column and detected by
Gas chromatography/electron capture
detector (GC/ECD). Recoveries ranged
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from 84% to 97% in samples fortified
with fenarimol at 0.02 ppm to 0.2 ppm.
The limit of detection via this method
is <0.02 ppm.
3. Magnitude of residues. IR-4 data
from 4 residue trials show residues of
fenarimol were <0.02 ppm in composite
samples of filbert treated at 0.09 pound
of active ingredient per acre (lb ai/A)
and composite samples treated at 0.18 lb
ai/A or two times the proposed
maximum application rate. The data
indicates that fenarimol residues would
not be expected to accumulate to
significant levels in filbert. Based on
these results and for purposes of this
petition, it is appropriate to base the
magnitude of total terminal residues and
proposed tolerance only on residues of
the parent compound, fenarimol.
B. Toxicological Profile
1. Acute toxicity. The acute oral lethal
dose (LD50) in the rat is 2,500 milligrams
per kilogram (mg/kg) and the acute
dermal LD50 in the rabbit is >2,000 mg/
kg. The inhalation lethal concentration
(LC50) in the rat is >2.04 mg/liter of air,
which is the highest obtainable
respirable aerosol concentration.
Fenarimol produced no indications of
dermal irritation in rabbits or
sensitization in the guinea pig. End use
formulations of fenarimol have similar
low acute toxicity profiles.
2. Genotoxicity. Fenarimol tested
negative in several assay systems for
gene mutation, structural chromosome
aberration, and other genotoxic effects.
In a micronucleus test in the mouse,
fenarimol did produce a significant
increase in the percent of polychromatic
erythrocytes with micronucleus at 24
hours but not at 48 or 72 hours.
Moreover, a second test run at a higher
dosage, which produced significant
toxicity including death, was
unequivocally negative.
3. Reproductive and developmental
toxicity. A developmental toxicity study
in rabbits was negative for teratogenic
effects at all doses tested (0, 5, 10, and
35 mg/kg). A developmental toxicity
study in rats demonstrated
hydronephrosis at 35 mg/kg (doses
tested were 0, 5, 10, and 35 mg/kg). A
second developmental toxicity study in
rats, with a postpartum evaluation,
again demonstrated hydronephrosis at
35 mg/kg. Maternal toxicity (decreased
body weight) was also observed at the
35 milligrams/kilogram/day (mg/kg/day)
dose level. The no observed effect level
(NOEL) for hydronephrosis and
maternal toxicity is 13 mg/kg.
4. Chronic toxicity. A 2–year chronic
toxicity and carcinogenicity study in
rats fed diets containing 0, 50, 130, or
350 ppm (equivalent to 2.5, 6.5, or 17.5
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mg/kg/day) resulted in a systemic NOEL
of 130 ppm, equivalent to 6.5 mg/kg/
day. An increase in fatty liver changes
was observed in rats fed diets
containing 350 ppm. There were no
carcinogenic effects observed under the
conditions of the study.
A second 2–year carcinogenicity
study was conducted in rats fed diets
containing 0, 12.5, 25, or 50 ppm,
equivalent to 0, 0.63, 1.25, or 2.5 mg/kg/
day. There was no apparent effect on
survival, which was reduced in all
treatment groups due to chronic
respiratory disease. An increased
incidence of fatty changes in the liver
was observed at the top dose level of 50
ppm, and the NOEL was established as
25 ppm (1.2 mg/kg/day) in this study. A
third 2–year carcinogenicity study was
conducted at the same dose levels as
above. The incidence of liver lesions
was similar in the treated and control
groups; thus the NOEL for liver effects
in this study was greater than 50 ppm
(2.5 mg/kg/day).
A 2–year feeding study was
conducted in mice fed diets containing
concentrations of 0, 50, 170, or 600
ppm, equivalent to 0, 7, 24.3, or 85.7
mg/kg/day. The 600 ppm dose level was
shown to increase liver weight. There
was no increase in cancer, and no
toxicologically significant treatment
related effects were observed at any
dose level. The NOEL was determined
to be 600 ppm (85.7 mg/kg/day).
In a 1–year chronic toxicity study,
dogs were fed diets containing 0, 1.25,
12.5, or 125 mg/kg/day. The NOEL was
12.5 mg/kg/day based upon an increase
in serum alkaline phosphatase,
increased liver weights, an increase in
p-nitroanisole o-demethylase activity,
and mild hepatic bile stasis at the high
dose level (125 mg/kg/day).
Based on the chronic toxicity data, the
chronic Reference Dose (RfD) for
fenarimol is established at 0.0006 mg/
kg/day. The RfD for fenarimol is based
on a 2–year chronic feeding study in
rats with a NOEL of 6.5 mg/kg/day and
an uncertainty factor of 1,000. For shortterm <35 day risk assessments to
females 13-50 years old, the Agency
selected a LOAEL of 35 mg/kg/day
based upon decreased fertility and
dystocia in rats and an uncertainty
factor of 3,000.
5. Animal metabolism. Metabolism
studies conducted in rats show
fenarimol is rapidly metabolized and
excreted. Major metabolic pathways
were oxidation of the carbinol-carbon
atom, the phenyl rings and the
pyrimidine ring.
6. Endocrine disruption. In a 3–
generation reproduction study with rats
and in subsequent special studies,
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fenarimol was determined to be a weak
inhibitor of aromatase. Rats dosed at 0,
12.5, 25, or 50 ppm (equivalent to 0,
0.625, 1.25, or 2.5 mg/kg/day)
demonstrated decreased fertility in
males at 25 ppm and delayed
parturition and dystocia in females at 25
and 50 ppm. The NOEL for reproductive
effects was 12.5 ppm (0.625 mg/kg/day).
The infertility effect in males is
considered to be a species-specific effect
mediated by the inhibition of aromatase,
an enzyme which catalyzes the
conversion of testosterone to estradiol.
Estradiol plays an essential role in the
developmental and maintenance of
sexual behavior in rats.
Multi-generation reproduction studies
in guinea pigs and mice were negative
for reproductive effects at the highest
dose levels tested, 35 mg/kg/day and 20
mg/kg/day, respectively. A NOEL of 35
mg/kg/day for reproductive effects
relevant to humans was established
based on the NOEL from the multigeneration reproduction study in guinea
pigs.
C. Aggregate Exposure
1. Dietary exposure—i. Food. For the
purposes of assessing the potential
dietary exposure from use on filbert, an
estimate of aggregate exposure is
determined by basing the TMRC from
previously established tolerances and
the proposed tolerance on filbert for
fenarimol at 0.02 parts per million
(ppm) and assuming the 100% of the
filbert crop has a residue of fenarimol at
the tolerance level.
Exposure of humans to residues could
also result if such residues are
transferred to meat, milk, poultry, or
eggs. Since there is no livestock feed
commodity associated with filbert, there
is no reasonable expectation that
measurable secondary residues of
fenarimol will occur in meat, milk,
poultry, or eggs under the terms of the
proposed use. Other established
tolerances for fenarimol on food or feed
crops in the United States are
established under 40 CFR 180.421. The
use of a tolerance level and 100% of
crop treated clearly results in an
overestimate of human exposure and a
safety determination for use on filbert
that is based on conservative exposure
assessment.
ii. Drinking water. Based upon the
available environmental studies
conducted with fenarimol wherein its
properties show little potential for
mobility in soil and extremely rapid
photolysis in water, there is no
anticipated exposure to residues of
fenarimol in drinking water.
2. Non-dietary exposure. The
proposed use on filbert involves
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51805
application of fenarimol to a crop grown
in an agricultural environment. Thus,
the potential for non-occupational, nondietary exposure to the general
population is not expected to be
significant. There are no residential uses
of fenarimol.
D. Cumulative Effects
There is no evidence that there is a
common mechanism of toxicity with
any other chemical compound or that
potential toxic effects of fenarimol
would be cumulative with those of any
other pesticide chemical. Thus it is
believed that it is appropriate to
consider only the potential risks of
fenarimol in its exposure assessment.
E. Safety Determination
1. U.S. population. It is concluded
that aggregate exposure to fenarimol
will utilize less than 2% of the chronic
RfD for the U.S. general population and
less than 14% of the acute RfD for
females 13-50 at the 99.9 percentile
level. EPA generally has no concern for
exposures below 100% of the RfD
because the RfD represents the level at
or below which daily aggregate dietary
exposure over a lifetime will not pose
appreciable risks to human health. It is
concluded that there is a reasonable
certainty that no harm will result from
aggregate exposure to fenarimol residues
in or on filbert.
2. Infants and children. In assessing
the potential for additional sensitivity of
infants and children to residues of
fenarimol, data from developmental
toxicity studies in rats and rabbits and
a multigeneration reproduction study in
the rat are considered. The
developmental toxicity studies are
designed to evaluate adverse effects on
the developing organism resulting from
pesticide exposure during prenatal
development to one or both parents.
Reproduction studies provide
information relating to effects from
exposure to the pesticide on the
reproductive capability and potential
systemic toxicity of mating animals and
on various parameters associated with
the well-being of offspring.
FFDCA section 408 provides that EPA
may apply an additional safety factor for
infants and children in the case of
threshold effects to account for pre- and
post-natal toxicity and the completeness
of the data base. Based on the current
toxicological data requirements, the data
base for fenarimol relative to pre- and
post-natal effects for children is
complete. Further, for fenarimol, the
NOEL in the chronic feeding study
which was used to calculate the RID (6.5
mg/kg/day used by EPA or 1.2 mg/kg/
day used by The World Health
E:\FR\FM\31AUN1.SGM
31AUN1
51806
Federal Register / Vol. 70, No. 168 / Wednesday, August 31, 2005 / Notices
Organization) is already lower than the
NOELs from the developmental studies
in rats and rabbits.
Concerning the multi-generation
reproduction study, the effects on
reproduction are considered to be
specific effect caused by aromatase
inhibition. The aromatase enzyme
promotes normal sexual behavior in rats
and mice, but not in guinea pigs or
primates, including humans. A NOEL of
35 mg/kg/day for reproductive effects
relevant to humans was established
based on the NOEL from the multigeneration reproduction study in guinea
pigs. In addition, a NOEL of 13 mg/kg/
day for developmental effects was
established based upon the NOEL from
the teratology study in rats. Therefore, it
is concluded that an additional
uncertainty factor is not needed and that
the RfD at 0.065 mg/kg/day is
appropriate for assessing risk to infants
and children.
F. International Tolerances
There is no Codex or national
maximum residue level established for
fenarimol on filbert.
[FR Doc. 05–17195 Filed 8–30–05; 8:45 am]
BILLING CODE 6560–50–S
ENVIRONMENTAL PROTECTION
AGENCY
[OPP–2005–0223; FRL–7730–2]
Pesticide Emergency Exemptions;
Agency Decisions and State and
Federal Agency Crisis Declarations
Environmental Protection
Agency (EPA).
ACTION: Notice.
AGENCY:
SUMMARY: EPA has granted or denied
emergency exemptions under the
Federal Insecticide, Fungicide, and
Rodenticide Act (FIFRA) for use of
pesticides as listed in this notice. The
exemptions or denials were granted
during the period April 1, 2005 to June
30, 2005 to control unforseen pest
outbreaks.
See
each emergency exemption or denial for
the name of a contact person. The
following information applies to all
contact persons: Team Leader,
Emergency Response Team, Registration
Division (7505C), Office of Pesticide
Programs, Environmental Protection
Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460–0001; telephone
number: (703) 308–9366.
SUPPLEMENTARY INFORMATION: EPA has
granted or denied emergency
exemptions to the following State and
FOR FURTHER INFORMATION CONTACT:
VerDate Aug<18>2005
16:33 Aug 30, 2005
Jkt 205001
Federal agencies. The emergency
exemptions may take the following
form: Crisis, public health, quarantine,
or specific. EPA has also listed denied
emergency exemption requests in this
notice.
I. General Information
A. Does this Action Apply to Me?
You may be potentially affected by
this action if you 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–2005–0223. 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 South 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
PO 00000
Frm 00060
Fmt 4703
Sfmt 4703
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. Background
Under FIFRA section 18, EPA can
authorize the use of a pesticide when
emergency conditions exist.
Authorizations (commonly called
emergency exemptions) are granted to
State and Federal agencies and are of
four types:
1. A ‘‘specific exemption’’ authorizes
use of a pesticide against specific pests
on a limited acreage in a particular
State. Most emergency exemptions are
specific exemptions.
2. ‘‘Quarantine’’ and ‘‘public health’’
exemptions are a particular form of
specific exemption issued for
quarantine or public health purposes.
These are rarely requested.
3. A ‘‘crisis exemption’’ is initiated by
a State or Federal agency (and is
confirmed by EPA) when there is
insufficient time to request and obtain
EPA permission for use of a pesticide in
an emergency.
EPA may deny an emergency
exemption: If the State or Federal
agency cannot demonstrate that an
emergency exists, if the use poses
unacceptable risks to the environment,
or if EPA cannot reach a conclusion that
the proposed pesticide use is likely to
result in ‘‘a reasonable certainty of no
harm’’ to human health, including
exposure of residues of the pesticide to
infants and children.
If the emergency use of the pesticide
on a food or feed commodity would
result in pesticide chemical residues,
EPA establishes a time-limited tolerance
meeting the ‘‘reasonable certainty of no
harm standard’’ of the Federal Food,
Drug, and Cosmetic Act (FFDCA).
In this document: EPA identifies the
State or Federal agency granted the
exemption or denial, the type of
exemption, the pesticide authorized and
the pests, the crop or use for which
authorized, number of acres (if
applicable), and the duration of the
exemption. EPA also gives the Federal
Register citation for the time-limited
tolerance, if any.
E:\FR\FM\31AUN1.SGM
31AUN1
]]>Agencies
[Federal Register Volume 70, Number 168 (Wednesday, August 31, 2005)]
[Notices]
[Pages 51802-51806]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-17195]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
[OPP-2005-0235; FRL-7733-1]
Fenarimol; 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-
2005-0235, must be received on or before September 30, 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: Barbara Madden, Registration Division
(7505C), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone
number: (703) 305-6463; e-mail address: madden.barbara@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 ID number OPP-2005-0235. 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
[[Page 51803]]
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.
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-2005-0235. 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-2005-0235. 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-2005-0235.
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-2005-0235. 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
[[Page 51804]]
the comment that does not contain the information claimed as CBI must
be submitted for inclusion in the public docket and EPA's electronic
public docket. If you submit the copy that does not contain CBI on disk
or CD ROM, mark the outside of the disk or CD ROM clearly that it does
not contain CBI. Information not marked as CBI will be included in the
public docket and EPA's electronic public docket without prior notice.
If you have any questions about CBI or the procedures for claiming CBI,
please consult the person listed under FOR FURTHER INFORMATION CONTACT.
E. What Should I Consider as I Prepare My Comments for EPA?
You may find the following suggestions helpful for preparing your
comments:
1. Explain your views as clearly as possible.
2. Describe any assumptions that you used.
3. Provide copies of any technical information and/or data you used
that support your views.
4. If you estimate potential burden or costs, explain how you
arrived at the estimate that you provide.
5. Provide specific examples to illustrate your concerns.
6. Make sure to submit your comments by the deadline in this
notice.
7. To ensure proper receipt by EPA, be sure to identify the docket
ID number assigned to this action in the subject line on the first page
of your response. You may also provide the name, date, and Federal
Register citation.
II. What Action is the Agency Taking?
EPA has received a pesticide petition as follows proposing the
establishment and/or amendment of regulations for residues of a certain
pesticide chemical in or on various food commodities under section 408
of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a.
EPA has determined that this petition contains data or information
regarding the elements set forth in FFDCA section 408(d)(2); however,
EPA has not fully evaluated the sufficiency of the submitted data at
this time or whether the data support granting of the petition.
Additional data may be needed before EPA rules on the petition.
List of Subjects
Environmental protection, Agricultural commodities, Feed additives,
Food additives, Pesticides and pests, Reporting and recordkeeping
requirements.
Dated: August 19, 2005.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.
Summary of Petition
The petitioner summary of the pesticide petition is printed below
as required by FFDCA section 408(d)(3). The summary of the petition was
prepared by the petitioner and represents the view of the petitioner.
The petition summary announces the availability of a description of the
analytical methods available to EPA for the detection and measurement
of the pesticide chemical residues or an explanation of why no such
method is needed.
Interregional Research Project Number 4
PP 5E4573
EPA has received a pesticide petition (PP 5E4573) from
Interregional Research Project Number 4 (IR-4), 681 U.S. Highway
1 South, North Brunswick, NJ 08902-3390 proposing, pursuant to
section 408(d) of the FFDCA, 21 U.S.C. 346a(d), to amend 40 CFR part
180 by establishing a tolerance for residues of fenarimol [alpha-(2-
chlorophenyl)-alpha-(4-chlorophenyl)-5-pyrimidinemethanol] in or on the
raw agricultural commodity filbert at 0.02 parts per million (ppm). EPA
has determined that the petition contains data or information regarding
the elements set forth in section 408(d)(2) of the FFDCA; however, EPA
has not fully evaluated the sufficiency of the submitted data at this
time or whether the data supports granting of the petition. Additional
data may be needed before EPA rules on the petition.
A. Residue Chemistry
1. Plant metabolism. The nature of the residue in fenarimol-treated
filbert has not been directly determined. Radioactive metabolism
studies with apples and cherries indicate that fenarimol is the only
significant component of the residue in apples and cherries. The
residue of concern in filbert is fenarimol.
2. Analytical method. Analytical methodology used for filbert is a
slight modification of the basic Pesticide analytical manual (PAM II)
method for fenarimol (Method R039). Residues are extracted with
methanol. Aqueous sodium chloride (5%) is added and the extract is
partitioned with dichloromethane. Residues are cleaned up on a Florisil
column and detected by Gas chromatography/electron capture detector
(GC/ECD). Recoveries ranged from 84% to 97% in samples fortified with
fenarimol at 0.02 ppm to 0.2 ppm. The limit of detection via this
method is <0.02 ppm.
3. Magnitude of residues. IR-4 data from 4 residue trials show
residues of fenarimol were <0.02 ppm in composite samples of filbert
treated at 0.09 pound of active ingredient per acre (lb ai/A) and
composite samples treated at 0.18 lb ai/A or two times the proposed
maximum application rate. The data indicates that fenarimol residues
would not be expected to accumulate to significant levels in filbert.
Based on these results and for purposes of this petition, it is
appropriate to base the magnitude of total terminal residues and
proposed tolerance only on residues of the parent compound, fenarimol.
B. Toxicological Profile
1. Acute toxicity. The acute oral lethal dose (LD50) in
the rat is 2,500 milligrams per kilogram (mg/kg) and the acute dermal
LD50 in the rabbit is >2,000 mg/kg. The inhalation lethal
concentration (LC50) in the rat is >2.04 mg/liter of air,
which is the highest obtainable respirable aerosol concentration.
Fenarimol produced no indications of dermal irritation in rabbits or
sensitization in the guinea pig. End use formulations of fenarimol have
similar low acute toxicity profiles.
2. Genotoxicity. Fenarimol tested negative in several assay systems
for gene mutation, structural chromosome aberration, and other
genotoxic effects. In a micronucleus test in the mouse, fenarimol did
produce a significant increase in the percent of polychromatic
erythrocytes with micronucleus at 24 hours but not at 48 or 72 hours.
Moreover, a second test run at a higher dosage, which produced
significant toxicity including death, was unequivocally negative.
3. Reproductive and developmental toxicity. A developmental
toxicity study in rabbits was negative for teratogenic effects at all
doses tested (0, 5, 10, and 35 mg/kg). A developmental toxicity study
in rats demonstrated hydronephrosis at 35 mg/kg (doses tested were 0,
5, 10, and 35 mg/kg). A second developmental toxicity study in rats,
with a postpartum evaluation, again demonstrated hydronephrosis at 35
mg/kg. Maternal toxicity (decreased body weight) was also observed at
the 35 milligrams/kilogram/day (mg/kg/day) dose level. The no observed
effect level (NOEL) for hydronephrosis and maternal toxicity is 13 mg/
kg.
4. Chronic toxicity. A 2-year chronic toxicity and carcinogenicity
study in rats fed diets containing 0, 50, 130, or 350 ppm (equivalent
to 2.5, 6.5, or 17.5
[[Page 51805]]
mg/kg/day) resulted in a systemic NOEL of 130 ppm, equivalent to 6.5
mg/kg/day. An increase in fatty liver changes was observed in rats fed
diets containing 350 ppm. There were no carcinogenic effects observed
under the conditions of the study.
A second 2-year carcinogenicity study was conducted in rats fed
diets containing 0, 12.5, 25, or 50 ppm, equivalent to 0, 0.63, 1.25,
or 2.5 mg/kg/day. There was no apparent effect on survival, which was
reduced in all treatment groups due to chronic respiratory disease. An
increased incidence of fatty changes in the liver was observed at the
top dose level of 50 ppm, and the NOEL was established as 25 ppm (1.2
mg/kg/day) in this study. A third 2-year carcinogenicity study was
conducted at the same dose levels as above. The incidence of liver
lesions was similar in the treated and control groups; thus the NOEL
for liver effects in this study was greater than 50 ppm (2.5 mg/kg/
day).
A 2-year feeding study was conducted in mice fed diets containing
concentrations of 0, 50, 170, or 600 ppm, equivalent to 0, 7, 24.3, or
85.7 mg/kg/day. The 600 ppm dose level was shown to increase liver
weight. There was no increase in cancer, and no toxicologically
significant treatment related effects were observed at any dose level.
The NOEL was determined to be 600 ppm (85.7 mg/kg/day).
In a 1-year chronic toxicity study, dogs were fed diets containing
0, 1.25, 12.5, or 125 mg/kg/day. The NOEL was 12.5 mg/kg/day based upon
an increase in serum alkaline phosphatase, increased liver weights, an
increase in p-nitroanisole o-demethylase activity, and mild hepatic
bile stasis at the high dose level (125 mg/kg/day).
Based on the chronic toxicity data, the chronic Reference Dose
(RfD) for fenarimol is established at 0.0006 mg/kg/day. The RfD for
fenarimol is based on a 2-year chronic feeding study in rats with a
NOEL of 6.5 mg/kg/day and an uncertainty factor of 1,000. For short-
term <35 day risk assessments to females 13-50 years old, the Agency
selected a LOAEL of 35 mg/kg/day based upon decreased fertility and
dystocia in rats and an uncertainty factor of 3,000.
5. Animal metabolism. Metabolism studies conducted in rats show
fenarimol is rapidly metabolized and excreted. Major metabolic pathways
were oxidation of the carbinol-carbon atom, the phenyl rings and the
pyrimidine ring.
6. Endocrine disruption. In a 3-generation reproduction study with
rats and in subsequent special studies, fenarimol was determined to be
a weak inhibitor of aromatase. Rats dosed at 0, 12.5, 25, or 50 ppm
(equivalent to 0, 0.625, 1.25, or 2.5 mg/kg/day) demonstrated decreased
fertility in males at 25 ppm and delayed parturition and dystocia in
females at 25 and 50 ppm. The NOEL for reproductive effects was 12.5
ppm (0.625 mg/kg/day). The infertility effect in males is considered to
be a species-specific effect mediated by the inhibition of aromatase,
an enzyme which catalyzes the conversion of testosterone to estradiol.
Estradiol plays an essential role in the developmental and maintenance
of sexual behavior in rats.
Multi-generation reproduction studies in guinea pigs and mice were
negative for reproductive effects at the highest dose levels tested, 35
mg/kg/day and 20 mg/kg/day, respectively. A NOEL of 35 mg/kg/day for
reproductive effects relevant to humans was established based on the
NOEL from the multi-generation reproduction study in guinea pigs.
C. Aggregate Exposure
1. Dietary exposure--i. Food. For the purposes of assessing the
potential dietary exposure from use on filbert, an estimate of
aggregate exposure is determined by basing the TMRC from previously
established tolerances and the proposed tolerance on filbert for
fenarimol at 0.02 parts per million (ppm) and assuming the 100% of the
filbert crop has a residue of fenarimol at the tolerance level.
Exposure of humans to residues could also result if such residues
are transferred to meat, milk, poultry, or eggs. Since there is no
livestock feed commodity associated with filbert, there is no
reasonable expectation that measurable secondary residues of fenarimol
will occur in meat, milk, poultry, or eggs under the terms of the
proposed use. Other established tolerances for fenarimol on food or
feed crops in the United States are established under 40 CFR 180.421.
The use of a tolerance level and 100% of crop treated clearly results
in an overestimate of human exposure and a safety determination for use
on filbert that is based on conservative exposure assessment.
ii. Drinking water. Based upon the available environmental studies
conducted with fenarimol wherein its properties show little potential
for mobility in soil and extremely rapid photolysis in water, there is
no anticipated exposure to residues of fenarimol in drinking water.
2. Non-dietary exposure. The proposed use on filbert involves
application of fenarimol to a crop grown in an agricultural
environment. Thus, the potential for non-occupational, non-dietary
exposure to the general population is not expected to be significant.
There are no residential uses of fenarimol.
D. Cumulative Effects
There is no evidence that there is a common mechanism of toxicity
with any other chemical compound or that potential toxic effects of
fenarimol would be cumulative with those of any other pesticide
chemical. Thus it is believed that it is appropriate to consider only
the potential risks of fenarimol in its exposure assessment.
E. Safety Determination
1. U.S. population. It is concluded that aggregate exposure to
fenarimol will utilize less than 2% of the chronic RfD for the U.S.
general population and less than 14% of the acute RfD for females 13-50
at the 99.9 percentile level. EPA generally has no concern for
exposures below 100% of the RfD because the RfD represents the level at
or below which daily aggregate dietary exposure over a lifetime will
not pose appreciable risks to human health. It is concluded that there
is a reasonable certainty that no harm will result from aggregate
exposure to fenarimol residues in or on filbert.
2. Infants and children. In assessing the potential for additional
sensitivity of infants and children to residues of fenarimol, data from
developmental toxicity studies in rats and rabbits and a
multigeneration reproduction study in the rat are considered. The
developmental toxicity studies are designed to evaluate adverse effects
on the developing organism resulting from pesticide exposure during
prenatal development to one or both parents. Reproduction studies
provide information relating to effects from exposure to the pesticide
on the reproductive capability and potential systemic toxicity of
mating animals and on various parameters associated with the well-being
of offspring.
FFDCA section 408 provides that EPA may apply an additional safety
factor for infants and children in the case of threshold effects to
account for pre- and post-natal toxicity and the completeness of the
data base. Based on the current toxicological data requirements, the
data base for fenarimol relative to pre- and post-natal effects for
children is complete. Further, for fenarimol, the NOEL in the chronic
feeding study which was used to calculate the RID (6.5 mg/kg/day used
by EPA or 1.2 mg/kg/day used by The World Health
[[Page 51806]]
Organization) is already lower than the NOELs from the developmental
studies in rats and rabbits.
Concerning the multi-generation reproduction study, the effects on
reproduction are considered to be specific effect caused by aromatase
inhibition. The aromatase enzyme promotes normal sexual behavior in
rats and mice, but not in guinea pigs or primates, including humans. A
NOEL of 35 mg/kg/day for reproductive effects relevant to humans was
established based on the NOEL from the multi-generation reproduction
study in guinea pigs. In addition, a NOEL of 13 mg/kg/day for
developmental effects was established based upon the NOEL from the
teratology study in rats. Therefore, it is concluded that an additional
uncertainty factor is not needed and that the RfD at 0.065 mg/kg/day is
appropriate for assessing risk to infants and children.
F. International Tolerances
There is no Codex or national maximum residue level established for
fenarimol on filbert.
[FR Doc. 05-17195 Filed 8-30-05; 8:45 am]
BILLING CODE 6560-50-S
