[Federal Register Volume 70, Number 50 (Wednesday, March 16, 2005)]
[Notices]
[Pages 12874-12879]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-5214]


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ENVIRONMENTAL PROTECTION AGENCY

[OPP-2005-0041; FRL-7700-2]


 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-
2005-0041], must be received on or before April 15, 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: 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].

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    You may be potentially affected by this action if you 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

[[Page 12875]]

(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-2005-0041. The official public docket 
consists of the documents specifically referenced in this action, any 
public comments received, and other information related to this action. 
Although a part of the official docket, the public docket does not 
include Confidential Business Information (CBI) or other information 
whose disclosure is restricted by statute. The official public docket 
is the collection of materials that is available for public viewing at 
the Public Information and Records Integrity Branch (PIRIB), Rm. 119, 
Crystal Mall 2, 1801 S. Bell St., Arlington, VA. This docket 
facility is open from 8:30 a.m. to 4 p.m., Monday through Friday, 
excluding legal holidays. The docket telephone number is (703) 305-
5805.
    2. Electronic access. You may access this Federal Register document 
electronically through the EPA Internet under the ``Federal Register'' 
listings at 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-2005-0041. 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-2005-0041. 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.

[[Page 12876]]

    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-2005-0041.
    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-2005-0041. 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 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: February 25, 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.

FMC Corporation

PP 4F6893

    EPA has received pesticide petition (PP4F6893) from FMC 
Corporation, 1735 Market Street, Philadelphia, PA 19103, proposing 
pursuant to section 408 (d) of the Federal Food, Drug and Cosmetic Act, 
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 all food/feed items (other than those covered by a 
higher tolerance as a result of use on growing crops) in food/feed 
handling establishments at 0.05 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 metabolism of cypermethrin in plants is 
adequately understood. Studies have been conducted to delineate the 
metabolism of radiolabelled 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 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. A food/feed handling establishment study 
conducted at the maximum label rate for all food/feed items (other than 
those covered by a higher tolerance as a result of use on growing 
crops) in food/feed handling establishments show that the proposed 
zeta-cypermethrin tolerance in or on all food/feed items (other than 
those covered by a higher tolerance as a result of use on growing 
crops) in food/feed handling establishments at 0.05 ppm will not be 
exceeded when the zeta-cypermethrin product labeled for this use are 
used as directed.

B. Toxicological Profile



    1. Acute toxicity. For the purposes of assessing acute dietary 
risk, FMC has used the NOEL of 10.0 mg/kg/day from the zeta-
cypermethrin acute neurotoxicity study in rats. The 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

[[Page 12877]]

vivo chromosomal aberration in rat bone marrow cells; in vitro 
cytogenic chromosome aberration; unscheduled DNA synthesis; CHO/HGPTT 
mutagen assay; weakly mutagenic: Gene mutation (Ames).
    3. Reproductive and developmental toxicity. No evidence of 
additional sensitivity to young rats was observed following pre- or 
postnatal exposure to zeta-cypermethrin.
    i. A two-generation reproductive toxicity study with zeta-
cypermethrin in rats demonstrated a NOEL of 7.0 mg/kg/day and a LOEL 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 NOEL for reproductive toxicity was 
considered to be > 45.0 mg/kg/day (the highest dose tested).
    ii. A developmental study with zeta-cypermethrin in rats 
demonstrated a maternal NOEL of 12.5 mg/kg/day and a LOEL 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 highest dose level tested.
    iii. A developmental study with cypermethrin in rabbits 
demonstrated a maternal NOEL of 100 mg/kg/day and a LOEL of 450 mg/kg/
day based on decreased body weight gain. There were no signs of 
developmental toxicity at 700 mg/kg/day, the highest dose level tested.
    4. Subchronic toxicity. Short- and intermediate-term toxicity 
(incidental oral exposure). The NOEL of 10.0 mg/kg/day based on 
clinical signs at the LEL of 50.0 mg/kg/day in the zeta-cypermethrin 
acute neurotoxicity study in rats would also be used for short-term 
%aPAD and MOE calculations (as well as acute, discussed in (1) above), 
and the NOEL 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 NOEL of 6.0 mg/kg/day 
from a cypermethrin chronic feeding study in dogs and an uncertainty 
factor 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 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 has 
utilized available information on anticipated residues, monitoring data 
and percent crop treated as follows:
    ii.  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 one day or single exposure. For the purposes of 
assessing acute dietary risk for zeta-cypermethrin, FMC has used the 
NOEL of 10.0 mg/kg/day from the zeta-cypermethrin acute neurotoxicity 
study in rats with an uncertainty factor (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 Population Adjusted Dose (%aPAD) all fall below the EPA's level 
of concern (>=100%). The 95th percentile of exposure for the overall U. 
S. population was estimated to be 0.001177 mg/kg/day (%aRfD of 1.2); 
99th percentile 0.003307 mg/kg/day (%aRfD of 3.3); and 99.9th 
percentile 0.012692 mg/kg/day (%aRfD of 12.7). The 95th percentile of 
exposure for all infants <1 year old was estimated to be 0.002441 mg/
kg/day (%aRfD of 2.4); 99th percentile 0.011178 mg/kg/day (%aRfD of 
11.2); and 99.9th percentile 0.029462 mg/kg/day (%aRfD of 29.5). The 
95th percentile of exposure for nursing infants <1 year old was 
estimated to be 0.001247 mg/kg/day (%aRfD of 1.3); 99th percentile 
0.004540 mg/kg/day (%aRfD of 4.5); and 99.9th percentile 0.011659 mg/
kg/day (%aRfD 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 (%aRfD of 2.8); 99th percentile 
0.012899 mg/kg/day (%aRfD of 12.9); and 99.9th percentile 0.033071 mg/
kg/day (%aRfD 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 (%aRfD of 1.9) and 0.001244 mg/kg/day 
(%aRfD of 1.2); 99th percentile 0.005670 mg/kg/day (%aRfD of 5.7) and 
0.003082 (%aRfD of 3.1); and 99.9th percentile 0.018280 mg/kg/day 
(%aRfD of 18.3) and 0.009335 (%aRfD of 9.3). The 95th percentile of 
exposure for females (13+/nursing) was estimated to be 0.001128 mg/kg/
day (%aRfD of 1.1); 99th percentile 0.003112 mg/kg/day (%aRfD of 3.1); 
and 99.9th percentile 0.012903 mg/kg/day (%aRfD of 12.9). Therefore, 
FMC concludes that the acute dietary risk of zeta-cypermethrin, as 
estimated by the dietary risk assessment, does not appear to be of 
concern.
    iii. Chronic exposure and risk. The chronic reference dose (cRfD) 
of 0.06 mg/kg/day for zeta-cypermethrin is based on a NOEL of 6.0 mg/
kg/day from a cypermethrin chronic feeding study in dogs and an 
uncertainty factor of 100.

[[Page 12878]]

 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 cRfD. 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 are estimated to 
be 0.000184 mg/kg body weight (bwt)/day and utilize 0.3 percent of the 
cRfD for the overall U. S. population. The ARC for non-nursing infants 
(<1 year) (subgroup most highly exposed) are estimated to be 0.000666 
mg/kg bwt/day and utilizes 1.1 percent of the cRfD, respectively. The 
ARC for children 1-6 years old and children 7-12 years old are 
estimated to be 0.000477 mg/kg bwt/day and 0.000254 mg/kg bwt/day and 
utilizes 0.8 percent and 0.4 percent of the cRfD, respectively. The ARC 
for females (13+/nursing) is estimated to be 0.000180 mg/kg bwt/day and 
utilizes 0.3 percent of the RfD. Generally speaking, the 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 
percent of the cRfD. Therefore, FMC concludes that the chronic dietary 
risk of zeta-cypermethrin, as estimated by the dietary risk assessment, 
does not appear to be of concern.
    iv. Drinking water. Laboratory and field data have demonstrated 
that cypermethrin is immobile in soil and will not leach into 
groundwater. Other data show that cypermethrin is virtually insoluble 
in water and extremely lipophilic. As a result, FMC 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 (DWEC) and the corresponding 
drinking water level of comparison (DWLOC) values were calculated for 
chronic and acute exposures. The results show that all DWLOC values 
exceed the DWEC values. Thus, exposure to zetacypermethrin and 
cypermethrin residues in drinking water is not of concern.
    US EPA's draft 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 
FQPA Index Reservoir Screening Tool (FIRST), PRZM/EXAMS, SCIGROW 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 the drinking water SOP compares a calculated Drinking 
Water Level of Comparison (DWLOC) value to the Drinking Water Estimated 
Concentration (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 drinking water level 
of comparison. This is the maximum allowable drinking water 
concentration (in ppb). The DWEC is the drinking water environmental 
concentration, which 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 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 zetacypermethrin 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 intends to submit information 
for the EPA to consider concerning potential cumulative effects of 
cypermethrin consistent with the schedule established by EPA at 62 FR 
42020 (August 4, 1997)(FRL-5734-6) and other EPA publications pursuant 
to the Food Quality Protection Act.

E. Safety Determination

    1. U. S. population. The chronic reference dose (cRfD) of 0.06 mg/
kg/day for zeta-cypermethrin is based on a NOEL of 6.0 mg/kg/day from a 
cypermethrin chronic feeding study in dogs and an uncertainty factor 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 cRfD. 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 are estimated to 
be 0.000184 mg/kg body weight (bwt)/day and utilize 0.3 percent of the 
cRfD for the overall U. S. population. The ARC for non-nursing infants 
(<1 year) (subgroup most highly exposed) are estimated to be 0.000666 
mg/kg bwt/day and utilizes 1.1 percent of the cRfD, respectively. The 
ARC for children 1-6 years old and children 7-12 years old are 
estimated to be 0.000477 mg/kg bwt/day and 0.000254 mg/kg bwt/day and 
utilizes 0.8 percent and 0.4 percent of the cRfD, respectively. The ARC 
for females (13+/nursing) is estimated to be 0.000180 mg/kg bwt/day and 
utilizes 0.3 percent of the RfD. Generally speaking, the 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 
percent of the cRfD. Therefore, FMC 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 one day or single 
exposure. For the purposes of assessing acute dietary risk for zeta-
cypermethrin, FMC has used the NOEL of 10.0 mg/kg/day from the zeta-
cypermethrin acute neurotoxicity study in rats with an uncertainty 
factor (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,

[[Page 12879]]

using Monte Carlo modeling for commodities that may be consumed in a 
single serving. These assessments show that the percent acute 
Population Adjusted Dose (%aPAD) all fall below the EPA's level of 
concern (>=100%). The 95th percentile of exposure for the overall U. S. 
population was estimated to be 0.001177 mg/kg/day (%aRfD of 1.2); 99th 
percentile 0.003307 mg/kg/day (%aRfD of 3.3); and 99.9th percentile 
0.012692 mg/kg/day (%aRfD of 12.7). The 95th percentile of exposure for 
all infants <1 year old was estimated to be 0.002441 mg/kg/day (%aRfD 
of 2.4); 99th percentile 0.011178 mg/kg/day (%aRfD of 11.2); and 99.9th 
percentile 0.029462 mg/kg/day (%aRfD of 29.5). The 95th percentile of 
exposure for nursing infants <1 year old was estimated to be 0.001247 
mg/kg/day (%aRfD of 1.3); 99th percentile 0.004540 mg/kg/day (%aRfD of 
4.5); and 99.9th percentile 0.011659 mg/kg/day (%aRfD 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 (%aRfD of 2.8); 99th percentile 0.012899 mg/kg/day (%aRfD of 
12.9); and 99.9th percentile 0.033071 mg/kg/day (%aRfD 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 
(%aRfD of 1.9) and 0.001244 mg/kg/day (%aRfD of 1.2); 99th percentile 
0.005670 mg/kg/day (%aRfD of 5.7) and 0.003082 (%aRfD of 3.1); and 
99.9th percentile 0.018280 mg/kg/day (%aRfD of 18.3) and 0.009335 
(%aRfD of 9.3). The 95th percentile of exposure for females (13+/
nursing) was estimated to be 0.001128 mg/kg/day (%aRfD of 1.1); 99th 
percentile 0.003112 mg/kg/day (%aRfD of 3.1); and 99.9th percentile 
0.012903 mg/kg/day (%aRfD of 12.9). Therefore, FMC 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 considered data from developmental toxicity studies 
in the rat and rabbit, and a two-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 reproductiveility 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 
thresholdeffects to account for pre- and post-natal toxicity and the 
completeness of the database.
    ii. Developmental toxicity studies. In the prenatal developmental 
toxicity studies in rats and rabbits, there was no evidence of 
developmental toxicity at the highest doses tested (35.0 mg/kg/day in 
rats and 700 mg/kg/day in rabbits). Decreased body weight gain was 
observed at the maternal LOEL in each study; the maternal NOEL was 
established at 12.5 mg/kg/day in rats and 100 mg/kg/day in rabbits.
    iii. Reproductive toxicity study. In the two-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 NOEL as 
7.0 mg/kg/day and the parental systemic LOEL was 27.0 mg/kg/day. There 
were no developmental (pup) or reproductive effects up to 45.0 mg/kg/
day, highest dose tested.
    iv. Pre- and post-natal sensitivity-- a.  Pre-natal. There was no 
evidence of developmental toxicity in the studies at the highest doses 
tested 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 wouldrequire an additional 
safety factor.
    b. Post-natal. Based on the absence of pup toxicity up to dose 
levels which produced toxicity in the parental animals, there is no 
evidence of special post-natal sensitivity to infants and children in 
the rat reproduction study.

3. Conclusion

    Based on the above, FMC concludes that reliable data support use of 
the standard 100-fold uncertainty factor, and that an additional 
uncertainty factor is not needed to protect the safety of infants and 
children. As stated above, aggregate exposure assessments utilized 
significantly less than 1 percent 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.

4. International Tolerances

    There are no Canadian, or Mexican residue limits for residues of 
cypermethrin or zeta-cypermethrin in or on all food/feed items (other 
than those covered by a higher tolerance as a result of use on growing 
crops) in food/feed handling establishments.

[FR Doc. 05-5214 Filed 3-15-05; 8:45 am]
BILLING CODE 6560-50-S