[Federal Register Volume 67, Number 149 (Friday, August 2, 2002)]
[Notices]
[Pages 50430-50435]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-19443]


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ENVIRONMENTAL PROTECTION AGENCY

[OPP-2002-0134; FRL-7185-9]


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-2002-0134, must be 
received on or before September 3, 2002.

ADDRESSES: Comments may be submitted by mail, electronically, or in 
person. Please follow the detailed instructions for each method as 
provided in Unit I.C. of the SUPPLEMENTARY INFORMATION. To ensure 
proper receipt by EPA, it is imperative that you identify docket ID 
number OPP-2002-0134 in the subject line on the first page of your 
response.

FOR FURTHER INFORMATION CONTACT: By mail: Linda A. DeLuise, 
Registration Division (7505C), Office of Pesticide Programs, 
Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460; 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 affected by this action if you are an agricultural 
producer, food manufacturer or pesticide manufacturer. Potentially 
affected categories and entities may include, but are not limited to:

------------------------------------------------------------------------
                                                          Examples of
           Categories                 NAICS codes         potentially
                                                       affected entities
------------------------------------------------------------------------
Industry                          111                 Crop production
                                  112                 Animal production
                                  311                 Food manufacturing
                                  32532               Pesticide
                                                       manufacturing
------------------------------------------------------------------------

    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 the table could also be 
affected. The North American Industrial Classification System (NAICS) 
codes have been provided to assist you and others in determining 
whether or not this action might apply to certain entities. If you have 
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 Additional Information, Including Copies of this 
Document and Other Related Documents?

    1. Electronically. You may obtain electronic copies of this 
document, and certain other related documents that might be available 
electronically, from the EPA Internet Home Page at http://www.epa.gov/. 
To access this document, on the Home Page select ``Laws and 
Regulations,'' ``Regulations and Proposed Rules'' and then look up the 
entry for this document under the ``Federal Register--Environmental 
Documents.'' You can also go directly to the Federal Register listings 
at http://www.epa.gov/fedrgstr/.
    2. In person. The Agency has established an official record for 
this action under docket ID number OPP-2002-0134. The official record 
consists of the documents specifically referenced in this action, any 
public comments received during an applicable comment period, and other 
information related to this action, including any information claimed 
as Confidential Business Information (CBI). This official record 
includes the documents that are physically located in the docket, as 
well as the documents that are referenced in those documents. The 
public version of the official record does not include any information 
claimed as CBI. The public version of the official record, which 
includes printed, paper versions of any electronic comments submitted 
during an applicable comment period, is available for inspection in the 
Public Information and Records Integrity Branch (PIRIB), Rm. 119, 
Crystal Mall #2, 1921 Jefferson Davis Highway, Arlington, VA, from 8:30 
a.m. to 4 p.m., Monday through Friday, excluding legal

[[Page 50431]]

holidays. The PIRIB telephone number is (703) 305-5805.

C. How and to Whom Do I Submit Comments?

    You may submit comments through the mail, in person, or 
electronically. To ensure proper receipt by EPA, it is imperative that 
you identify docket ID number OPP-2002-0134 in the subject line on the 
first page of your response.
    1. By mail. Submit your comments to: Public Information and Records 
Integrity Branch (PIRIB), Information Resources and Services Division 
(7502C), Office of Pesticide Programs (OPP), Environmental Protection 
Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460.
    2. In person or by courier. Deliver your comments to: Public 
Information and Records Integrity Branch (PIRIB), Information Resources 
and Services Division (7502C), Office of Pesticide Programs (OPP), 
Environmental Protection Agency, Rm. 119, Crystal Mall #2, 1921 
Jefferson Davis Highway, Arlington, VA. The PIRIB is open from 8:30 
a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The 
PIRIB telephone number is (703) 305-5805.
    3. Electronically. You may submit your comments electronically by 
e-mail to: [email protected], or you can submit a computer disk as 
described above. Do not submit any information electronically that you 
consider to be CBI. Avoid the use of special characters and any form of 
encryption. Electronic submissions will be accepted in Wordperfect 6.1/
8.0 or ASCII file format. All comments in electronic form must be 
identified by docket ID number OPP-2002-0134. Electronic comments may 
also be filed online at many Federal Depository Libraries.

D. How Should I Handle CBI That I Want to Submit to the Agency?

    Do not submit any information electronically that you consider to 
be CBI. You may claim information that you submit to EPA in response to 
this document as CBI by marking any part or all of that information as 
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 version of the 
official record. Information not marked confidential will be included 
in the public version of the official record without prior notice. If 
you have any questions about CBI or the procedures for claiming CBI, 
please consult the person identified 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 o 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 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: July 23, 2002.
Peter Caulkins,
Acting Director, Registration Division, Office of Pesticide Programs.

Summary of Petition

    The petitioner summary of the pesticide petition is printed below 
as required by section 408(d)(3) of the FFDCA. The summary of the 
petition was prepared by the petitioner and represents the view of the 
petitioner. EPA is publishing the petition summary verbatim without 
editing it in any way. 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

2F6444

    EPA has received a pesticide petition (2F6444) 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 part 180, by establishing a tolerance for residues of zeta-
cypermethrins-Cyano(3-phenoxyphenyl)methyl () cis, trans 3-
(2,2-dichloroethenyl)-2,2-dimethylcyclopropanecarboxylate and its 
inactive isomers) in or on the raw agricultural commodities (RACs) root 
and tuber vegetables, roots at 0.10 part per million (ppm); peanuts at 
0.05 ppm; and cucurbit vegetables at 0.10 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 are 
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 (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 root and tuber 
vegetables, peanuts, and cucurbit vegetables show that the proposed 
zeta-cypermethrin tolerances on root and tuber vegetables, roots at 
0.10 ppm; peanuts at 0.05 ppm; and cucurbit vegetables at 0.10 ppm will 
not be exceeded when the zeta-cypermethrin products labeled for these 
uses are used as directed.

[[Page 50432]]

B. Toxicological Profile

    1. Acute toxicity. For the purposes of assessing acute dietary 
risk, FMC Corporation has used the no observed adverse effect levels 
(NOAEL) at 10.0 milligram/kilograms/day (mg/kg/day) from the zeta-
cypermethrin acute neurotoxicity study in rats. The lowest observed 
adverse effect levels (LOAEL) at 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. Genotoxicty. The following genotoxicity tests were all 
negative:
    i. In vivo chromosomal aberration in rat bone marrow cells.
    ii. In vitro cytogenic chromosome aberration.
    iii. Unscheduled DNA synthesis (UDS).
    iv. 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 at 7.0 mg/kg/day and the 
LOAEL at 27.0 mg/kg/day for parental/systemic toxicity based on body 
weight (bwt), 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 at 12.5 mg/kg/day and a LOAEL at 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.
    iii. A developmental study with cypermethrin in rabbits 
demonstrated a maternal NOAEL at 100 mg/kg/day and a LOAEL at 450 mg/
kg/day based on decreased body weight gain. There were no signs of 
developmental toxicity at 700 mg/kg/day, the HDT.
    4. Subchronic toxicity. Short-term and intermediate-term toxicity 
(incidental oral exposure). The NOAEL at 10.0 mg/kg/day based on 
clinical signs at the lowest effect level (LEL) at 50.0 mg/kg/day in 
the zeta-cypermethrin acute neurotoxicity study in rats would also be 
used for short-term percent of the acute population adjusted dose 
(aPAD) and margin of exposure (MOE) calculations (as well as acute, 
discussed in paragraph (1) above), and the NOAEL at 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) at 0.06 
mg/kg/day for zeta-cypermethrin is based on a NOAEL at 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 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:
    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 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 
of acute PAD all fall below EPA's level of concern (LOC) 
(100%). The 95th percentile of exposure for the 
overall U.S. population was estimated to be 0.001012 mg/kg/day (percent 
of the acute RfD at 1.01); 99th percentile 0.002913 mg/kg/
day (percent of the acute RfD at 2.91); and 99.9th 
percentile 0.012145 mg/kg/day (percent of the acute RfD at 12.14). The 
95th percentile of exposure for all infants <1 year old was 
estimated to be 0.000716 mg/kg/day (percent of the acute RfD at 0.72); 
99th percentile 0.005735 mg/kg/day (percent of the acute RfD 
at 5.74); and 99.9th percentile 0.027673 mg/kg/day (percent 
of the acute RfD of 27.67). The 95th percentile of exposure 
for nursing infants 1 year old was estimated to be 0.000420 mg/kg/day 
(percent of the acute RfD at 0.42); 99th percentile 0.001087 
mg/kg/day (percent of the acute RfD at 1.09); and 99.9th percentile 
0.004944 mg/kg/day (percent of the acute RfD at 4.94). The 
95th percentile of exposure for non-nursing infants <1 year 
old (the most highly exposed population subgroup) was estimated to be 
0.000826 mg/kg/day (percent of the acute RfD at 0.83); 99th 
percentile 0.011124 mg/kg/day (percent of the acute RfD at 11.12); and 
99.9th percentile 0.031431 mg/kg/day (percent of the acute 
RfD of 31.43). The 95th percentile of exposure for

[[Page 50433]]

children 1 to 6 years old and children 7 to 12 years old was estimated 
to be, respectively, 0.001228 mg/kg/day (percent of the acute RfD at 
1.23) and 0.001001 mg/kg/day (percent of the acute RfD at 1.0); 
99th, percentile 0.003716 mg/kg/day (percent of the acute 
RfD at 3.72) and 0.002724 (percent of the acute RfD at 2.72); and 
99.9th percentile 0.015244 mg/kg/day (percent of the acute 
RfD at 15.24) and 0.008805 (percent of the acute RfD at 8.81). The 
95th percentile of exposure for females (13+/nursing) was 
estimated to be 0.001051mg/kg/day (percent of the acute RfD at 1.05); 
99th percentile 0.003029 mg/kg/day (percent of the acute RfD 
at 3.03); and 99.9th percentile 0.013146 mg/kg/day (percent 
of the acute RfD at 13.15). 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.
    iii. Chronic exposure risk. The chronic RfD at 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 
are 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 nursing 
infants (<1 year) and non-nursing infants (<1 year) (subgroup most 
highly exposed) are estimated to be 0.000052 mg/kg bwt/day and 0.000380 
mg/kg bwt/day and utilizes 0.1% and 0.6% of the chronic RfD, 
respectively. The ARC for children 1 to 6 years old and children 7 to 
12 years old are estimated to be 0.000337 mg/kg bwt/day and 0.000203 
mg/kg bwt/day and utilizes 0.6% and 0.3% of the chronic RfD, 
respectively. The ARC for females (13+/nursing) are estimated to be 
0.000177 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.
    iv. 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 (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 zeta-cypermethrin and 
cypermethrin residues in drinking water is not of concern. 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 the Food 
Quailty Protection Act/Index Reservoir Screening Tool (FQPA)(FIRST), 
EPA's Pesticide Root Zone Model/Exposure Analysis Modeling System 
(PRZM/EXAMS), Screening Concentration in Ground Water (SCIGROW), and 
monitoring data. If monitoring data is 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 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:
    a. The DWLOC and the DWEC. The DWLOC is the drinking water level of 
comparsion. This is the maximum allowable drinking water concentration 
(in parts per billion). The DWEC is the drinking water environmental 
concentration, which is derived either from monitoring studies or from 
modeling.
    b. 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 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 at (62 
FR 42020, August 4, 1997) (FRL-5734-6), and other EPA publications 
pursuant to the FQPA.

E. Safety Determination

    1. U.S. population. The chronic RfD at 0.06 mg/kg/day for zeta-
cypermethrin is based on a NOAEL at 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 
bwt/day and utilize 0.3% of the chronic RfD for the overall U.S. 
population. The ARC for nursing infants (<1 year) and non-nursing 
infants (<1 year) (subgroup most highly exposed) are estimated to be 
0.000052 mg/kg bwt/day and 0.000380 mg/kg bwt/day and utilizes 0.1% and 
0.6% of the chronic RfD, respectively. The ARC for children 1 to 6 
years old and children 7 to 12 years old are estimated to be 0.000337 
mg/kg bwt/day

[[Page 50434]]

 and 0.000203 mg/kg bwt/day and utilizes 0.6% and 0.3% of the chronic 
RfD, respectively. The ARC for females (13+/nursing) are estimated to 
be 0.000177 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 of acute PAD all fall below EPA's LOC 
(100%). The 95th percentile of exposure for the 
overall U.S. popuation was estimated to be 0.001012 mg/kg/day (percent 
of the acute RfD at 1.01); 99th percentile 0.002913 mg/kg/
day (percent of the acute RfD at 2.91); and 99.9th 
percentile 0.012145 mg/kg/day (percent of the acute RfD at 12.14). The 
95th percentile of exposure for all infants <1 year old was 
estimated to be 0.000716 mg/kg/day (percent of the acute RfD at 0.72); 
99th percentile 0.005735 mg/kg/day (percent of the acute RfD 
at 5.74); and 99.9th percentile 0.027673 mg/kg/day (percent 
of the acute RfD at 27.67). The 95th percentile of exposure 
for nursing infants <1 year old was estimated to be 0.000420 mg/kg/day 
(percent of the acute RfD at 0.42); 99th percentile 0.001087 
mg/kg/day (percent of the acute RfD at 1.09); and 99.9th 
percentile 0.004944 mg/kg/day (percent of the acute RfD at 4.94). The 
95th percentile of exposure for non-nursing infants <1 year 
old (the most highly exposed population subgroup) was estimated to be 
0.000826 mg/kg/day (percent of the acute RfD at 0.83); 99th 
percentile 0.011124 mg/kg/day (percent of the acute RfD at 11.12); and 
99.9 th percentile 0.031431 mg/kg/day (percent of the acute 
RfD at 31.43). The 95th percentile of exposure for children 
1 to 6 years old and children 7 to 12 years old was estimated to be, 
respectively, 0.001228 mg/kg/day (percent of the acute RfD at 1.23); 
and 0.001001 mg/kg/day (percent of the acute RfD at 1.0); 
99th percentile 0.003716 mg/kg/day (percent of the acute RfD 
at 3.72); and 0.002724 (percent of the acute RfD at 2.72); and 
99.9th percentile 0.015244 mg/kg/day (percent of the acute 
RfD of 15.24); and 0.008805 (percent of the acute RfD at 8.81). The 
95th percentile of exposure for females (13+/nursing) was 
estimated to be 0.001051 mg/kg/day (percent of the acute RfD at 1.05); 
99th percentile 0.003029 mg/kg/day (percent of the acute RfD 
at 3.03); and 99.9th percentile 0.013146 mg/kg/day (percent 
acute RfD at 13.15). 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, 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 (MOS) 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), parental toxicity 
(body weight, organ weight, and clinical signs), were 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 no 
developmental (pup) or reproductive effects up to 45.0 mg/kg/day, HDT.
    iv. Prenatal and postnatal sensitivity--a. 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.
    b. 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.
    v. 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 cucurbit vegetables, 
peanuts, root, and tuber vegetables. The Codex maximum residue levels 
for cypermethrin are cucumbers 0.2 ppm; peanuts 0.05 ppm; and for root 
and tuber vegetables 0.05 ppm.

[FR Doc. 02-19443 Filed 8-1-02; 8:45 am]
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