[Federal Register: July 16, 2003 (Volume 68, Number 136)]
[Notices]
[Page 42030-42035]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr16jy03-82]
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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:
deluise.linda@epa.gov@epa.gov
deluise.linda@epa.gov@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 opp-docket@epa.gov,
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