[Federal Register Volume 70, Number 168 (Wednesday, August 31, 2005)]
[Notices]
[Pages 51802-51806]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-17195]


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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.

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SUMMARY: This notice announces the initial filing of a pesticide 
petition proposing the establishment of regulations for residues of a 
certain pesticide chemical in or on various food commodities.

DATES: Comments, identified by docket identification (ID) number OPP-
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: <a href="/cdn-cgi/l/email-protection#5538343131303b7b37342737342734153025347b323a23"><span class="__cf_email__" data-cfemail="bfd2dedbdbdad191dddecddddecddeffdacfde91d8d0c9">[email protected]</span></a>.

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:
    <bullet> Crop production (NAICS 111)
    <bullet> Animal production (NAICS 112)
    <bullet> Food manufacturing (NAICS 311)
    <bullet> 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 <greek-i>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 http://www.epa.gov/fedrgstr/
.
    An electronic version of the public docket is available through 
EPA's electronic public docket and comment system, EPA Dockets. You may 
use EPA Dockets at http://www.epa.gov/edocket/ to submit or view public 
comments, access the index listing of the contents of the official 
public docket, and to access those documents in the public docket that 
are available electronically. Although not all docket materials may be 
available electronically, you may still access any of the publicly 
available docket materials through the docket facility identified in 
Unit I.B.1. Once in the system, select ``search,'' then key in the 
appropriate docket ID number.
    Certain types of information will not be placed in the EPA Dockets. 
Information claimed as CBI and other information whose disclosure is 
restricted by statute, which is not included in the official public 
docket, will not be available for public viewing in EPA's electronic 
public docket. EPA's policy is that copyrighted material will not be 
placed in EPA's electronic public docket but will be available only in 
printed, paper form in the official public docket. To the extent 
feasible, publicly available docket materials will be made available in 
EPA's electronic public docket. When a document is selected from the 
index list in EPA Dockets, the system will identify whether the 
document is available for viewing in EPA's electronic public docket. 
Although not all docket materials may be available electronically, you 
may still access any of the publicly available docket materials through 
the docket facility identified in Unit I.B.1 EPA intends to work 
towards providing electronic access to all of the publicly available 
docket materials through EPA's electronic public docket.
    For public commenters, it is important to note that EPA's policy is 
that public comments, whether submitted electronically or in paper, 
will be made available for public viewing in EPA's electronic public 
docket as EPA receives them and without change, unless the comment 
contains copyrighted material, CBI, or other information whose 
disclosure is restricted by statute. When EPA identifies a comment 
containing copyrighted material, EPA will provide a reference to that 
material in the version of the comment that is placed in EPA's 
electronic public docket. The entire printed comment, including the 
copyrighted material, will be available in the public docket.
    Public comments submitted on computer disks that are mailed or 
delivered to the docket will be transferred to EPA's electronic public 
docket. Public comments that are mailed or delivered to the docket will 
be scanned and placed in EPA's electronic public docket. Where 
practical, physical objects will be photographed, and the photograph 
will be placed in EPA's electronic public docket along with a brief 
description written by the docket staff.

C. How and to Whom Do I Submit Comments?

    You may submit comments electronically, by mail, or through hand 
delivery/courier. To ensure proper receipt by EPA, identify the 
appropriate docket ID number in the subject line on the first page of 
your comment. Please ensure that your comments are submitted within the 
specified comment period. Comments received after the close of the 
comment period will be marked ``late.'' EPA is not required to consider 
these late comments. If you wish to submit CBI or information that is 
otherwise protected by statute, please follow the instructions in Unit 
I.D. Do not use EPA Dockets or e-mail to submit CBI or information 
protected by statute.
    1. Electronically. If you submit an electronic comment as 
prescribed in this unit, EPA recommends that you include your name, 
mailing address, and an e-mail address or other contact information in 
the body of your comment. Also include this contact information on the 
outside of any disk or CD ROM you submit, and in any cover letter 
accompanying the disk or CD ROM. This ensures that you can be 
identified as the submitter of the comment and allows EPA to contact 
you in case EPA cannot read your comment due to technical difficulties 
or needs further information on the substance of your comment. EPA's 
policy is that EPA will not edit your comment, and any identifying or 
contact information provided in the body of a comment will be included 
as part of the comment that is placed in the official public docket, 
and made available in EPA's electronic public docket. If EPA cannot 
read your comment due to technical difficulties and cannot contact you 
for clarification, EPA may not be able to consider your comment.
    i. EPA Dockets. Your use of EPA's electronic public docket to 
submit comments to EPA electronically is EPA's preferred method for 
receiving comments. Go directly to EPA Dockets at http://www.epa.gov/edocket/, and follow the online instructions for submitting comments. 
Once in the system, select ``search,'' and then key in docket ID number 
OPP-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 <a href="/cdn-cgi/l/email-protection#214e51510c454e424a4455614451400f464e57"><span class="__cf_email__" data-cfemail="204f50500d444f434b4554604550410e474f56">[email protected]</span></a>, 
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 
<greek-i>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 
<greek-i>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 (LD<INF>50</INF>) in 
the rat is 2,500 milligrams per kilogram (mg/kg) and the acute dermal 
LD<INF>50</INF> in the rabbit is >2,000 mg/kg. The inhalation lethal 
concentration (LC<INF>50</INF>) 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


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