[Federal Register Volume 68, Number 136 (Wednesday, July 16, 2003)]
[Notices]
[Pages 42030-42035]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-17898]


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ENVIRONMENTAL PROTECTION AGENCY

[OPP-2003-0225; FRL-7314-7]


Zeta-cypermethrin and its inactive isomers; 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 ID number OPP-2003-0225, must be 
received on or before August 15, 2003.

ADDRESSES: Comments may be submitted electronically, by mail, or 
through hand delivery/courier. Follow the detailed instructions as 
provided in Unit I. of the SUPPLEMENTARY INFORMATION.

FOR FURTHER INFORMATION CONTACT: Linda A. DeLuise, Registration 
Division (7505C), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001; telephone number: (703) 305-5428; e-mail address: 
[email protected]@epa.gov.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    You may be potentially affected by this action if you are an 
agricultural producer, food manufacturer, or pesticide manufacturer. 
Potentially affected entities may include, but are not limited to:
    [sbull] Crop protection (NAICS 111)
    [sbull] Animal production (NAICS 112)
    [sbull] Food manufacturing (NAICS 311)
    [sbull] Pesticide manufacturing (NAICS 32532)
    This listing is not intended to be exhaustive, but rather provides 
a guide for readers regarding entities likely to be affected by this 
action. Other types of entities not listed in this unit could also be 
affected. The North American Industrial Classification System (NAICS) 
codes have been provided to assist you and others in determining 
whether this action might apply to certain entities. If you have any 
questions regarding the applicability of this action to a particular 
entity, consult the person listed under FOR FURTHER INFORMATION 
CONTACT.

B. How Can I Get Copies of this Document and Other Related Information?

    1. Docket. EPA has established an official public docket for this 
action under docket identification (ID) number OPP-2003-0225. The 
official public docket consists of the documents specifically 
referenced in this action, any public comments received, and other 
information related to this action. Although a part of the official 
docket, the public docket does not include Confidential Business 
Information (CBI) or other information whose disclosure is restricted 
by statute. The official public docket is the collection of materials 
that is available for public viewing at the Public Information and 
Records Integrity Branch (PIRIB), Rm. 119, Crystal Mall 2, 
1921 Jefferson Davis Hwy., Arlington, VA. This docket facility is open 
from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal 
holidays. The docket telephone number is (703) 305-5805.
    2. Electronic access. You may access this Federal Register document 
electronically through the EPA Internet under the ``Federal Register'' 
listings at http://www.epa.gov/fedrgstr/.
    An electronic version of the public docket is available through 
EPA's electronic public docket and comment system, EPA Dockets. You may 
use EPA Dockets at http://www.epa.gov/edocket/ to submit or view public 
comments, access the index listing of the contents of the official 
public docket, and to access those documents in the public docket that 
are available electronically. Although not all docket materials may be 
available electronically, you may still access any of the publicly 
available docket materials through the docket facility identified in 
Unit I.B.1. Once in the system, select ``search,'' then key in the 
appropriate docket ID number.
    Certain types of information will not be placed in EPA's 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. 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

[[Page 42031]]

docket. Public comments that are mailed or delivered to the docket will 
be scanned and placed in EPA's electronic public docket. Where 
practical, physical objects will be photographed, and the photograph 
will be placed in EPA's electronic public docket along with a brief 
description written by the docket staff.

C. How and to Whom Do I Submit Comments?

    You may submit comments electronically, by mail, or through hand 
delivery/courier. To ensure proper receipt by EPA, identify the 
appropriate docket ID number in the subject line on the first page of 
your comment. Please ensure that your comments are submitted within the 
specified comment period. Comments received after the close of the 
comment period will be marked ``late.'' EPA is not required to consider 
these late comments. If you wish to submit CBI or information that is 
otherwise protected by statute, please follow the instructions in Unit 
I.D. Do not use EPA Dockets or e-mail to submit CBI or information 
protected by statute.
    1. Electronically. If you submit an electronic comment as 
prescribed in this unit, EPA recommends that you include your name, 
mailing address, and an e-mail address or other contact information in 
the body of your comment. Also include this contact information on the 
outside of any disk or CD ROM you submit, and in any cover letter 
accompanying the disk or CD ROM. This ensures that you can be 
identified as the submitter of the comment and allows EPA to contact 
you in case EPA cannot read your comment due to technical difficulties 
or needs further information on the substance of your comment. EPA's 
policy is that EPA will not edit your comment, and any identifying or 
contact information provided in the body of a comment will be included 
as part of the comment that is placed in the official public docket, 
and made available in EPA's electronic public docket. If EPA cannot 
read your comment due to technical difficulties and cannot contact you 
for clarification, EPA may not be able to consider your comment.
    i. EPA Dockets. Your use of EPA's electronic public docket to 
submit comments to EPA electronically is EPA's preferred method for 
receiving comments. Go directly to EPA Dockets at http://www.epa.gov/edocket, and follow the online instructions for submitting comments. 
Once in the system, select ``search,'' and then key in docket ID number 
OPP-2003-0225. The system is an ``anonymous access'' system, which 
means EPA will not know your identity, e-mail address, or other contact 
information unless you provide it in the body of your comment.
    ii. E-mail. Comments may be sent by e-mail to [email protected], 
Attention: Docket ID number OPP-2003-0225. In contrast to EPA's 
electronic public docket, EPA's e-mail system is not an ``anonymous 
access'' system. If you send an e-mail comment directly to the docket 
without going through EPA's electronic public docket, EPA's e-mail 
system automatically captures your e-mail address. E-mail addresses 
that are automatically captured by EPA's e-mail system are included as 
part of the comment that is placed in the official public docket, and 
made available in EPA's electronic public docket.
    iii. Disk or CD ROM. You may submit comments on a disk or CD ROM 
that you mail to the mailing address identified in Unit I.C.2. These 
electronic submissions will be accepted in WordPerfect or ASCII file 
format. Avoid the use of special characters and any form of encryption.
    2. By mail. Send your comments to: Public Information and Records 
Integrity Branch (PIRIB) (7502C), Office of Pesticide Programs (OPP), 
Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460-0001, Attention: Docket ID number OPP-2003-0225.
    3. By hand delivery or courier. Deliver your comments to: Public 
Information and Records Integrity Branch (PIRIB), Office of Pesticide 
Programs (OPP), Environmental Protection Agency, Rm. 119, Crystal Mall 
2, 1921 Jefferson Davis Hwy., Arlington, VA, Attention: Docket 
ID number OPP-2003-0225. Such deliveries are only accepted during the 
docket's normal hours of operation as identified in Unit I.B.1.

D. How Should I Submit CBI to the Agency?

    Do not submit information that you consider to be CBI 
electronically through EPA's electronic public docket or by e-mail. You 
may claim information that you submit to EPA as CBI by marking any part 
or all of that information as CBI (if you submit CBI on disk or CD ROM, 
mark the outside of the disk or CD ROM as CBI and then identify 
electronically within the disk or CD ROM the specific information that 
is CBI). Information so marked will not be disclosed except in 
accordance with procedures set forth in 40 CFR part 2.
    In addition to one complete version of the comment that includes 
any information claimed as CBI, a copy of the comment that does not 
contain the information claimed as CBI must be submitted for inclusion 
in the public docket and EPA's electronic public docket. If you submit 
the copy that does not contain CBI on disk or CD ROM, mark the outside 
of the disk or CD ROM clearly that it does not contain CBI. Information 
not marked as CBI will be included in the public docket and EPA's 
electronic public docket without prior notice. If you have any 
questions about CBI or the procedures for claiming CBI, please consult 
the person listed under FOR FURTHER INFORMATION CONTACT.

E. What Should I Consider as I Prepare My Comments for EPA?

    You may find the following suggestions helpful for preparing your 
comments:
    1. Explain your views as clearly as possible.
    2. Describe any assumptions that you used.
    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 contain 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.


[[Page 42032]]


    Dated: July 3, 2003.
Debra Edwards,
Director, Registration Division, Office of Pesticide Programs.

Summary of Petition

    The petitioner's 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.

FMC Corporation

PP 3F6577

    EPA has received pesticide petition (3F6577) from FMC Corporation, 
1735 Market Street, Philadelphia, PA 19103, proposing pursuant to 
section 408(d) of the FFDCA, 21 U.S.C. 346a(d), to amend 40 CFR 180.418 
by establishing a tolerance for residues of the insecticide zeta-
cypermethrin (+/--[alpha]-cyano(3-phenoxyphenyl)methyl (+/-) cis, trans 
3-(2,2-dichloroethenyl)-2,2-dimethylcyclopropanecarboxylate) and its 
inactive isomers in or on the raw agricultural commodity fruit, pome, 
group 11, at 0.6 ppm and fruit, stone, group 12, at 0.9 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 support granting of the petition. Additional data 
may be needed before EPA rules on the petition.

A. Residue Chemistry

    1. Plant metabolism. The metabolism of cypermethrin in plants is 
adequately understood. Studies have been conducted to delineate the 
metabolism of radiolabeled cypermethrin in various crops all showing 
similar results. The residue of concern is the parent compound only.
    2. Analytical method. There is a practical analytical method for 
detecting and measuring levels of cypermethrin in or on food with a 
limit of detection (LOD) that allows monitoring of food with residues 
at or above the levels set in these tolerances (gas chromatography with 
electron capture detection (GC/ECD)).
    3. Magnitude of residues. Crop field trial residue data from 
studies conducted at the maximum label rates for representative 
commodities for pome fruit and stone fruit crop groups root, show that 
the proposed zeta-cypermethrin tolerances on fruit, pome, group 11, at 
0.6 ppm and fruit, stone, group 12, at 0.9 ppm; will not be exceeded 
when the zeta-cypermethrin products labeled for these uses are used as 
directed.

B. Toxicological Profile

    1. Acute toxicity. For the purposes of assessing acute dietary 
risk, FMC Corporation has used the no observed adverse effect level 
(NOAEL) of 10.0 milligrams/kilogram/day (mg/kg/day) from the zeta-
cypermethrin acute neurotoxicity study in rats. The lowest observed 
adverse effect level (LOAEL) of 50.0 mg/kg/day was based on clinical 
signs. This acute dietary endpoint is used to determine acute dietary 
risks to all population subgroups.
    2. Genotoxicity. The following genotoxicity tests were all 
negative: In vivo chromosomal aberration in rat bone marrow cells; in 
vitro cytogenic chromosome aberration; unscheduled DNA synthesis (UDS); 
Chinese Hampster Ovary/Hypoxanthine Guanine Phophoribosyl Transferase 
(CHO/HGPRT) mutagen assay; weakly mutagenic: gene mutation (Ames).
    3. Reproductive and developmental toxicity. No evidence of 
additional sensitivity to young rats was observed following prenatal or 
postnatal exposure to zeta-cypermethrin.
    i. A 2-generation reproductive toxicity study with zeta-
cypermethrin in rats demonstrated a NOAEL of 7.0 mg/kg/day and a LOAEL 
of 27.0 mg/kg/day for parental/systemic toxicity based on body weight, 
organ weight, and clinical signs. There were no adverse effects in 
reproductive performance. The NOAEL for reproductive toxicity was 
considered to be >45.0 mg/kg/day (the highest dose tested (HDT)).
    ii. A developmental study with zeta-cypermethrin in rats 
demonstrated a maternal NOAEL of 12.5 mg/kg/day and a LOAEL of 25 mg/
kg/day based on decreased maternal body weight gain, food consumption, 
and clinical signs. There were no signs of developmental toxicity at 
35.0 mg/kg/day, the HDT level.
    iii. A developmental study with cypermethrin in rabbits 
demonstrated a maternal NOAEL of 100 mg/kg/day and a LOAEL of 450 mg/
kg/day based on decreased body weight gain. There were no signs of 
developmental toxicity at 700 mg/kg/day, the HDT level.
    4. Subchronic toxicity. Short-term and intermediate-term toxicity 
(incidental oral exposure). The NOAEL of 10.0 mg/kg/day based on 
clinical signs at the lowest effect level (LEL) of 50.0 mg/kg/day in 
the zeta-cypermethrin acute neurotoxicity study in rats would also be 
used for short-term percent acute population adjusted dose (PAD) and 
margin of exposure (MOE) calculations (as well as acute, discussed in 
(1) above), and the NOAEL of 5.0 mg/kg/day based on decreased motor 
activity in the zeta-cypermethrin subchronic neurotoxicity study in 
rats, would be used for intermediate-term MOE calculations.
    5. Chronic toxicity--i. The chronic reference dose (RfD) of 0.06 
mg/kg/day for zeta-cypermethrin is based on a NOAEL of 6.0 mg/kg/day 
from a cypermethrin chronic feeding study in dogs and an uncertainty 
factor (UF) of 100. The endpoint effect of concern was based on 
clinical signs.
    ii. Cypermethrin is classified as a Group C chemical (possible 
human carcinogen with limited evidence of carcinogenicity in animals) 
based upon limited evidence for carcinogenicity in female mice; 
assignment of a Q* has not been recommended.
    6. Animal metabolism. The metabolism of cypermethrin in animals is 
adequately understood. Cypermethrin has been shown to be rapidly 
absorbed, distributed, and excreted in rats when administered orally. 
Cypermethrin is metabolized by hydrolysis and oxidation.
    7. Metabolite toxicology. The Agency has previously determined that 
the metabolites of cypermethrin are not of toxicological concern and 
need not be included in the tolerance expression nor in the risk 
exposure assessments.
    8. Endocrine disruption. No special studies investigating potential 
estrogenic or other endocrine effects of cypermethrin have been 
conducted. However, no evidence of such effects were reported in the 
standard battery of required toxicology studies which have been 
completed and found acceptable. Based on these studies, there is no 
evidence to suggest that cypermethrin has an adverse effect on the 
endocrine system.

C. Aggregate Exposure

    1. Dietary exposure--i. Food. Permanent tolerances, in support of 
registrations, currently exist for residues of zeta-cypermethrin on: 
Alfalfa hay, alfalfa forage, alfalfa seed, aspirated grain fractions, 
sugar beets (roots and tops), head, stem and leafy brassica vegetables, 
cabbage, field corn grain, pop corn grain, field corn forage, field 
corn stover, pop corn stover, sweet corn (K+CWHR), sweet corn forage, 
sweet corn stover, cottonseed, dried shelled peas and beans, edible 
podded legume

[[Page 42033]]

vegetables, fruiting vegetables (except cucurbits), leafy vegetables, 
head lettuce, bulb and green onions, pecans, rice grain, rice hulls, 
rice straw, sorghum forage, sorghum grain, sorghum stover, soybean 
seed, succulent shelled peas and beans, sugarcane, wheat forage, wheat 
grain, wheat hay, wheat straw, meat, fat, and meat byproducts of 
cattle, goats, hogs, horses, and poultry, eggs, milk and milk fat. For 
the purposes of assessing the potential dietary exposure for these 
existing and the subject proposed tolerances, FMC Corporation has 
utilized available information on anticipated residues, monitoring data 
and percent crop treated as follows:
    i. Acute exposure and risk. Acute dietary exposure risk assessments 
are performed for a food-use pesticide, if a toxicological study has 
indicated the possibility of an effect of concern occurring as a result 
of a 1-day or single exposure. For the purposes of assessing acute 
dietary risk for zeta-cypermethrin, FMC Corporation has used the NOAEL 
of 10.0 mg/kg/day from the zeta-cypermethrin acute neurotoxicity study 
in rats with an UF of 100 (acute RfD = 0.10 mg/kg/day). The LEL of 50.0 
mg/kg/day was based on clinical signs. This acute dietary endpoint is 
used to determine acute dietary risks to all population subgroups. 
Available information on anticipated residues, monitoring data and 
percent crop treated was incorporated into a Tier 3 analysis, using 
Monte Carlo modeling for commodities that may be consumed in a single 
serving. These assessments show that the percent acute PAD all fall 
below EPA's level of concern (>=100%). The 95\th\ percentile of 
exposure for the overall U.S. population was estimated to be 0.001177 
mg/kg/day (percent acute RfD of 1.2); 99\th\ percentile 0.003307 mg/kg/
day (percent acute RfD of 3.3); and 99.9\th\ percentile 0.012692 mg/kg/
day (percent acute RfD of 12.7). The 95\th\ percentile of exposure for 
all infants <1-year old was estimated to be 0.002441 mg/kg/day (percent 
acute RfD of 2.4); 99\th\ percentile 0.011178 mg/kg/day (percent acute 
RfD of 11.2); and 99.9\th\ percentile 0.029462 mg/kg/day (percent acute 
RfD of 29.5). The 95\th\ percentile of exposure for nursing infants <1-
year old was estimated to be 0.001247 mg/kg/day (percent acute RfD of 
1.3); 99\th\ percentile 0.004540 mg/kg/day (percent acute RfD of 4.5); 
and 99.9\th\ percentile 0.011659 mg/kg/day (percent acute RfD of 11.7). 
The 95\th\ percentile of exposure for non-nursing infants <1-year old 
(the most highly exposed population subgroup) was estimated to be 
0.002786 mg/kg/day (percent acute RfD of 2.8); 99\th\ percentile 
0.012899 mg/kg/day (percent acute RfD of 12.9); and 99.9\th\ percentile 
0.033071 mg/kg/day (percent acute RfD of 33.1). The 95\th\ percentile 
of exposure for children 1 to 6 years old and children 7 to 12 years 
old was estimated to be, respectively, 0.001942 mg/kg/day (percent 
acute RfD of 1.9) and 0.001244 mg/kg/day (percent acute RfD of 1.2); 
99\th\ percentile 0.005670 mg/kg/day (percent acute RfD of 5.7) and 
0.003082 (percent acute RfD of 3.1); and 99.9\th\ percentile 0.018280 
mg/kg/day (percent acute RfD of 18.3) and 0.009335 (percent acute RfD 
of 9.3). The 95\th\ percentile of exposure for females (13+/nursing) 
was estimated to be 0.001128 mg/kg/day (percent acute RfD of 1.1); 
99\th\ percentile 0.003112 mg/kg/day (percent acute RfD of 3.1); and 
99.9\th\ percentile 0.012903 mg/kg/day (percent acute RfD of 12.9). 
Therefore, FMC Corporation concludes that the acute dietary risk of 
zeta-cypermethrin, as estimated by the dietary risk assessment, does 
not appear to be of concern.
    ii. Chronic exposure and risk. The chronic RfD of 0.06 mg/kg/day 
for zeta-cypermethrin is based on a NOAEL of 6.0 mg/kg/day from a 
cypermethrin chronic feeding study in dogs and an UF of 100. The 
endpoint effect of concern was based on clinical signs. A chronic 
dietary exposure/risk assessment has been performed for zeta-
cypermethrin using the above chronic RfD. Available information on 
anticipated residues, monitoring data and percent crop treated was 
incorporated into the analysis to estimate the anticipated residue 
contribution (ARC). The ARC is generally considered a more realistic 
estimate than an estimate based on tolerance level residues. The ARC is 
estimated to be 0.000184 mg/kg body weight (bwt)/day and utilize 0.3% 
of the chronic RfD for the overall U.S. population. The ARC for non-
nursing infants (<1-year) (subgroup most highly exposed) is estimated 
to be 0.000666 mg/kg bwt/day and utilizes 1.1% of the chronic RfD, 
respectively. The ARCs for children 1 to 6 years old and children 7 to 
12 years old are estimated to be 0.000477 mg/kg bwt/day and 0.000254 
mg/kg bwt/day and utilizes 0.8% and 0.4% of the chronic RfD, 
respectively. The ARC for females (13+/nursing) is estimated to be 
0.000180 mg/kg bwt/day and utilizes 0.3% of the RfD. Generally 
speaking, EPA has no cause for concern if the total dietary exposure 
from residues for uses for which there are published and proposed 
tolerances is less than 100% of the chronic RfD. Therefore, FMC 
Corporation concludes that the chronic dietary risk of zeta-
cypermethrin, as estimated by the dietary risk assessment, does not 
appear to be of concern.
    iii. Drinking water. Laboratory and field data have demonstrated 
that cypermethrin is immobile in soil and will not leach into ground 
water. Other data show that cypermethrin is virtually insoluble in 
water and extremely lipophilic. As a result, FMC Corporation concludes 
that residues reaching surface waters from field runoff will quickly 
adsorb to sediment particles and be partitioned from the water column. 
Drinking water estimated concentrations (DWECs) and the corresponding 
drinking water level of comparison (DWLOCs) values were calculated for 
chronic and acute exposures. The results show that all DWLOC values 
exceed the DWEC values. Thus, exposure to zeta-cypermethrin and 
cypermethrin residues in drinking water is not of concern.
    EPA's draft Standard Operating Procedures (SOP) for incorporating 
estimates of drinking water exposure into aggregate risk assessments 
was used to perform a drinking water analysis. This SOP utilizes a 
variety of tools to conduct drinking water assessment. These tools 
include water models such as (Food Quality Protection Act (FQPA) FQPA 
Index Reservoir Screening Tool (FIRST)), EPA Pesticide Root Zone Model/
Exposure Analysis Modeling System (PRZM/EXAMS), Screening Concentration 
in Groundwater (SCI-GROW), and monitoring data. If monitoring data are 
not available then the models are used to predict potential residues in 
drinking water. The technique recommended in drinking water SOP 
compares a calculated DWLOC value to the DWEC value. The DWEC value 
results from either the monitoring data residues or modeled water 
residues. If the DWLOC value exceeds the DWEC value then there is 
reasonable certainty that no harm will result from the acute or chronic 
aggregate exposure.
    In the case of cypermethrin and zeta-cypermethrin, monitoring data 
do not exist. Therefore, the FIRST model was used to estimate a surface 
water residue. The risk assessment for drinking water compares two 
values: The DWLOC and the DWEC. The DWLOC is the maximum allowable 
drinking water concentration (in part per billion (ppb)). The DWEC is 
derived either from monitoring studies or from modeling. If the DWLOC 
is greater than the DWEC, then the overall exposure from water, food, 
and residential is considered to be acceptable. The calculated DWLOC 
values for acute and chronic exposures for all adults, adult females, 
and

[[Page 42034]]

children exceed the modeled DWEC surface water residues. Therefore, 
there is reasonable certainty that no harm will result from cumulative 
and aggregate (food and water) exposure to cypermethrin and zeta-
cypermethrin residues.
    2. Non-dietary exposure. Zeta-cypermethrin is registered for 
agricultural crop applications only, therefore non-dietary exposure 
assessments are not warranted.

D. Cumulative Effects

    In consideration of potential cumulative effects of cypermethrin 
and other substances that may have a common mechanism of toxicity, to 
our knowledge there are currently no available data or other reliable 
information indicating that any toxic effects produced by cypermethrin 
would be cumulative with those of other chemical compounds; thus only 
the potential risks of cypermethrin have been considered in this 
assessment of its aggregate exposure. FMC Corporation intends to submit 
information for EPA to consider concerning potential cumulative effects 
of cypermethrin consistent with the schedule established by EPA in the 
Federal Register of August 4, 1997 (62 FR 42020) (FRL-5734-6) and other 
EPA publications pursuant to the FQPA.

E. Safety Determination

    1. U.S. population. The chronic RfD of 0.06 mg/kg/day for zeta-
cypermethrin is based on a NOAEL of 6.0 mg/kg/day from a cypermethrin 
chronic feeding study in dogs and an UF of 100. The endpoint effect of 
concern was based on clinical signs. A chronic dietary exposure/risk 
assessment has been performed for zeta-cypermethrin using the above 
chronic RfD. Available information on anticipated residues, monitoring 
data and percent crop treated was incorporated into the analysis to 
estimate the ARC. The ARC is generally considered a more realistic 
estimate than an estimate based on tolerance level residues. The ARC is 
estimated to be 0.000184 mg/kg bwt/day and utilize 0.3% of the chronic 
RfD for the overall U.S. population. The ARC for non-nursing infants 
(<1-year) (subgroup most highly exposed) is estimated to be 0.000666 
mg/kg bwt/day and utilizes 1.1% of the chronic RfD, respectively. The 
ARCs for children 1 to 6 years old and children 7 to 12 years old are 
estimated to be 0.000477 mg/kg bwt/day and 0.000254 mg/kg bwt/day and 
utilizes 0.8% and 0.4% of the chronic RfD, respectively. The ARC for 
females (13+/nursing) is estimated to be 0.000180 mg/kg bwt/day and 
utilizes 0.3% of the RfD. Generally speaking, EPA has no cause for 
concern if the total dietary exposure from residues for uses for which 
there are published and proposed tolerances is less than 100% of the 
chronic RfD. Therefore, FMC Corporation concludes that the chronic 
dietary risk of zeta-cypermethrin, as estimated by the dietary risk 
assessment, does not appear to be of concern.
    Acute dietary exposure risk assessments are performed for a food-
use pesticide if a toxicological study has indicated the possibility of 
an effect of concern occurring as a result of a 1-day or single 
exposure. For the purposes of assessing acute dietary risk for zeta-
cypermethrin, FMC Corporation has used the NOAEL of 10.0 mg/kg/day from 
the zeta-cypermethrin acute neurotoxicity study in rats with an UF of 
100 (acute RfD = 0.10 mg/kg/day). The LEL of 50.0 mg/kg/day was based 
on clinical signs. This acute dietary endpoint is used to determine 
acute dietary risks to all population subgroups. Available information 
on anticipated residues, monitoring data and percent crop treated was 
incorporated into a Tier 3 analysis, using Monte Carlo modeling for 
commodities that may be consumed in a single serving. These assessments 
show that the percent acute (percent PAD) all fall below EPA's level of 
concern (>=100%). The 95\th\ percentile of exposure for the overall 
U.S. population was estimated to be 0.001177 mg/kg/day (percent acute 
RfD of 1.2); 99\th\ percentile 0.003307 mg/kg/day (percent acute RfD of 
3.3); and 99.9\th\ percentile 0.012692 mg/kg/day (percent acute RfD of 
12.7). The 95\th\ percentile of exposure for all infants <1-year old 
was estimated to be 0.002441 mg/kg/day (percent acute RfD of 2.4); 
99\th\ percentile 0.011178 mg/kg/day (percent acute RfD of 11.2); and 
99.9\th\ percentile 0.029462 mg/kg/day (percent acute RfD of 29.5). The 
95\th\ percentile of exposure for nursing infants <1-year old was 
estimated to be 0.001247 mg/kg/day (percent acute RfD of 1.3); 99\th\ 
percentile 0.004540 mg/kg/day (percent acute RfD of 4.5); and 
99.9th percentile 0.011659 mg/kg/day (percent acute RfD of 
11.7). The 95th percentile of exposure for non-nursing 
infants <1-year old (the most highly exposed population subgroup) was 
estimated to be 0.002786 mg/kg/day (percent acute RfD of 2.8); 
99th percentile 0.012899 mg/kg/day (percent acute RfD of 
12.9); and 99.9th percentile 0.033071 mg/kg/day (percent 
acute RfD of 33.1). The 95th percentile of exposure for 
children 1 to 6 years old and children 7 to 12 years old was estimated 
to be, respectively, 0.001942 mg/kg/day (percent acute RfD of 1.9) and 
0.001244 mg/kg/day (percent acute RfD of 1.2); 99th 
percentile 0.005670 mg/kg/day (percent acute RfD of 5.7) and 0.003082 
(percent acute RfD of 3.1); and 99.9th percentile 0.018280 
mg/kg/day (percent acute RfD of 18.3) and 0.009335 (percent acute RfD 
of 9.3). The 95th percentile of exposure for females (13+/
nursing) was estimated to be 0.001128 mg/kg/day (percent acute RfD of 
1.1); 99th percentile 0.003112 mg/kg/day (percent acute RfD 
of 3.1); and 99.9th percentile 0.012903 mg/kg/day (percent 
acute RfD of 12.9). Therefore, FMC Corporation concludes that the acute 
dietary risk of zeta-cypermethrin, as estimated by the dietary risk 
assessment, does not appear to be of concern.
    2. Infants and children--i. General. In assessing the potential for 
additional sensitivity of infants and children to residues of zeta-
cypermethrin, FMC Corporation considered data from developmental 
toxicity studies in the rat and rabbit, and a 2-generation reproductive 
study in the rat. The data demonstrated no indication of increased 
sensitivity of rats to zeta-cypermethrin or rabbits to cypermethrin in 
utero and/or postnatal exposure to zeta-cypermethrin or cypermethrin. 
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 of mating animals and data on 
systemic toxicity. FFDCA section 408 provides that EPA may apply an 
additional margin of safety for infants and children in the case of 
threshold effects to account for prenatal and postnatal toxicity and 
the completeness of the data base.
    ii. Developmental toxicity studies. In the prenatal developmental 
toxicity studies in rats and rabbits, there was no evidence of 
developmental toxicity at the HDT (35.0 mg/kg/day in rats and 700 mg/
kg/day in rabbits). Decreased body weight gain was observed at the 
maternal LOAEL in each study; the maternal NOAEL was established at 
12.5 mg/kg/day in rats and 100 mg/kg/day in rabbits.
    iii. Reproductive toxicity study. In the 2-generation reproduction 
study in rats, offspring toxicity (body weight) and parental toxicity 
(body weight, organ weight, and clinical signs) was observed at 27.0 
mg/kg/day and greater. The parental systemic NOAEL was 7.0 mg/kg/day 
and the parental systemic LOAEL was 27.0 mg/kg/day. There were

[[Page 42035]]

no developmental (pup) or reproductive effects up to 45.0 mg/kg/day, 
HDT.
    iv. Prenatal and postnatal sensitivity--i. Prenatal. There was no 
evidence of developmental toxicity in the studies at the HDT in the rat 
(70.0 mg/kg/day) or in the rabbit (700 mg/kg/day). Therefore, there is 
no evidence of a special dietary risk (either acute or chronic) for 
infants and children which would require an additional safety factor.
    v. Postnatal. Based on the absence of pup toxicity up to dose 
levels which produced toxicity in the parental animals, there is no 
evidence of special postnatal sensitivity to infants and children in 
the rat reproduction study.
    vi. Conclusion. Based on the above, FMC Corporation concludes that 
reliable data support use of the standard 100-fold UF, and that an 
additional UF is not needed to protect the safety of infants and 
children. As stated above, aggregate exposure assessments utilized 
significantly less than 1% of the RfD for either the entire U.S. 
population or any of the 26 population subgroups including infants and 
children. Therefore, it may be concluded that there is reasonable 
certainty that no harm will result to infants and children from 
aggregate exposure to cypermethrin residues.

F. International Tolerances

    There are no Canadian, or Mexican residue limits, for residues of 
cypermethrin or zeta-cypermethrin in or on pome fruits crop group or 
stone fruits crop group. The codex maximum residue levels for 
cypermethrin are 2.0 ppm for nectarine, 2.0 ppm for peaches, 1.0 for 
plums (including prunes), and 2.0 ppm for pome fruits.
[FR Doc. 03-17898 Filed 7-15-03; 8:45 am]
BILLING CODE 6560-50-S