[Federal Register Volume 65, Number 217 (Wednesday, November 8, 2000)]
[Notices]
[Pages 66998-67005]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-28421]


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ENVIRONMENTAL PROTECTION AGENCY

[PF-980; FRL-6750-2]


Notice of Filing Pesticide Petitions to Establish Tolerances for 
Certain Pesticide Chemicals in or on Food

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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

DATES: Comments, identified by docket control number PF-980, must be 
received on or before December 8, 2000.

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 
control number PF-980 in the subject line on the first page of your 
response.

FOR FURTHER INFORMATION CONTACT:  By mail: Linda DeLuise, Registration 
Division (7505C), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW.,

[[Page 66999]]

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:

------------------------------------------------------------------------
                                                          Eamples 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 ehaustive, 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 control number PF-980. 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, ecluding legal 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 control number PF-980 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, ecluding 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 control number PF-980. 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 ecept 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. Eplain 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, eplain how you 
arrived at the estimate that you provide.
    5. Provide specific eamples 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 
control 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 pesticide petitions as follows proposing the 
establishment and/or amendment of regulations for residues of certain 
pesticide chemicals in or on various food commodities under section 408 
of the Federal Food, Drug, and Comestic Act (FFDCA), 21 U.S.C. 346a. 
EPA has determined that these petitions contain 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 petitions. Additional data 
may be needed before EPA rules on the petitions.

[[Page 67000]]

List of Subjects

    Environmental protection, Agricultural commodities, Feed additives, 
Food additives, Pesticides and pests, Reporting and recordkeeping 
requirements.


    Dated: October 25, 2000.

  Peter Caulkins,

Acting Director, Registration Division, Office of Pesticide Programs.

Summaries of Petitions

    The petitioner summaries of the pesticide petitions 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 petitions summaries verbatim without 
editing it in any way. The petitions summaries announces the 
availability of a description of the analytical methods available to 
EPA for the detection and measurement of the pesticide chemicals 
residues or an eplanation of why no such method is needed.

1. FMC Corporation

PP 0F6207

    EPA has received a pesticide petition PP 0F6207 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 tolerances for residues of the insecticide 
zeta-cypermethrin (-a-Cyano(3-phenoxyphenyl)methyl 
() cis, trans 3-(2,2-dichloroethenyl)-2,2-
dimethylcyclopropanecarboxylate) in or on the raw agricultural 
commodities (RAC): wheat, grain at 0.15 parts per million (ppm); wheat, 
forage, at 2.5 ppm; wheat, hay at 6.0 ppm; wheat, straw at 6.5 ppm; 
wheat, bran at 0.20 ppm; sorghum, grain, at 0.50 ppm; sorghum, forage 
at 0.10 ppm; sorghum, fodder at 1.5 ppm; tomatoes at 0.10 ppm; peppers 
at 0.30 ppm; peas and beans (dried, succulent, and edible podded) at 
0.50 ppm; soybeans at 0.05 ppm; poultry, meat at 0.05 ppm; poultry, 
meat by-products at 0.05 ppm; poultry, fat at 0.05 ppm and, eggs at 
0.05 ppm; meat of cattle, goats, hogs, horses, and, sheep at 0.3 ppm; 
fat of cattle, goats, hogs, horses, and sheep at 0.30 ppm; and, milk, 
fat at 0.2 ppm (reflecting 0.01 ppm in whole milk).

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. Crop field trial residue data from 
studies conducted at the maimum label rates for wheat, sorghum, peas, 
beans, soybeans, tomatoes, and peppers show that the proposed zeta-
cypermethrin tolerances on wheat, grain at 0.15 ppm; wheat, forage, at 
2.5 ppm; wheat, hay at 6.0 ppm; wheat, straw at 6.5 ppm; wheat, bran at 
0.20 ppm; sorghum, grain, at 0.50 ppm; sorghum, forage at 0.10 ppm; 
sorghum, fodder at 1.5 ppm; tomatoes at 0.10 ppm; peppers at 0.30 ppm; 
peas, and beans (dried, succulent, and edible podded) at 0.50 ppm; 
soybeans at 0.05 ppm; will not be eceeded 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 has used the no observed adverse effect level (NOAEL) of 10.0 
milligrams/kilograms (mg/kg)/day from the zeta-cypermethrin acute 
neurotoxicityy study in rats. The lowest effect level (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.
    2. Genotoxicty. The following genotoxicity tests were all negative: 
In vivo chromosomal aberration in rat bone marrow cells; in vitro 
cytogenic chromosome aberration; unscheduled DNA synthesis; chinese 
hampster ovary/hypoanthine 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).
    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 highest dose level tested.
    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 highest dose level tested.
    4. Subchronic toxicity. Short- and intermediate-term toxicity. The 
NOAEL 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- and intermediate-term MOE calculations (as well 
as acute, discussed in (1) above).
    5. Chronic toxicity-- i. The reference dose (RfD) of 0.005 mg/kg/
day for zeta-cypermethrin is based on a NOAEL of 1.0 mg/kg/day from a 
cypermethrin dog chronic study and an uncertainty factor of 200 (used 
to account for the differences in the percentage of the biologically 
active isomer). The endpoint effect of concern was based on 
gastrointestinal disturbances.
    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 oidation.
    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 epression.
    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.

[[Page 67001]]

C. Aggregate exposure

    1. Dietary exposure--i. Food. Permanent tolerances, in support of 
registrations, currently eist for residues of zeta- cypermethrin on 
cottonseed, pecans, lettuce, head, onions, bulb, cabbage, and, 
livestock commodities of cattle, goats, hogs, horses, and sheep (along 
with the associated meat and milk tolerances). For the purposes of 
assessing the potential dietary exposure for these eisting and the 
subject proposed tolerances, FMC has utilized available information on 
anticipated residues, monitoring data and percent crop treated as 
follows:
    a. 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 NOAEL of 10.0 mg/
kg/day from the zeta-cypermethrin acute neurotoxicity study in rats. 
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 margins 
of exposure (MOE) are significantly greater than the EPA standard of 
100 for all subpopulations. The 95th percentile of exposure for the 
overall U.S. population was estimated to be 0.000630 mg/kg/day (margin 
of exposure (MOE) of 15884); 99th percentile 0.002184 mg/kg/day (MOE of 
4577); and 99.9th percentile 0.010260 mg/kg/day (MOE of 974). The 95th 
percentile of exposure for all infants 1 year old was estimated to be 
0.000599 mg/kg/day (MOE of 16682); 99th percentile 0.005656 mg/kg/day 
(MOE of 1768); and 99.9th percentile 0.029094 mg/kg/day (MOE of 343). 
The 95th percentile of exposure for nursing infants  1 year old was 
estimated to be 0.000172 mg/kg/day (MOE of 58054); 99th percentile 
0.000967 mg/kg/day (MOE of 10336); and 99.9th percentile 0.004937 mg/
kg/day (MOE of 2025). The 95th percentile of exposure for non-nursing 
infants  1 year old (the most highly exposed population subgroup) was 
estimated to be 0.000760 mg/kg/day (MOE of 13155); 99th percentile 
0.011082 mg/kg/day (MOE of 902); and 99.9th percentile 0.032957 mg/kg/
day (MOE of 303). The 95th percentile of exposure for children 1 to 6 
years old and children 7 to 12 years old was estimated to be, 
respectively, 0.000936 mg/kg/day (MOE of 10681) and 0.000644 mg/kg/day 
(MOE of 15524); 99th percentile 0.002768 mg/kg/day (MOE of 3612) and 
0.001945 (MOE of 5141); and 99.9th percentile 0.012752 mg/kg/day (MOE 
of 784) and 0.006688 (MOE of 1495). The 95th percentile of exposure for 
females (13+/nursing) was estimated to be 0.000602 mg/kg/day (MOE of 
16602); 99th percentile 0.002340 mg/kg/day (MOE of 4273); and 99.9th 
percentile 0.011387 mg/kg/day (MOE of 878). 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.
    b. Chronic exposure and risk. The RfD of 0.0125 mg/kg/day for zeta- 
cypermethrin is based on a NOAEL of 1.0 mg/kg/day from a cypermethrin 
dog chronic study and an uncertainty factor of 200 (used to account for 
the differences in the percentage of the biologically active isomer). 
The endpoint effect of concern was based on gastrointestinal 
disturbances. A chronic dietary exposure/risk assessment has been 
performed for zeta-cypermethrin using the above 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 0.000151 mg/kg body weight (bwt)/day and 
utilize 3.0% of the 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 0.000024 mg/kg bwt/day and 
0.000335 mg/kg bwt/day and utilizes 0.5% and 6.7% of the RfD, 
respectively. The ARC for children 1-6 years old and children 7-12 
years old are estimated to be 0.000285 mg/kg bwt/day and 0.000168 mg/kg 
bwt/day and utilizes 5.7 percent and 3.4 percent of the RfD, 
respectively. The ARC for females (13+/nursing) are estimated to be 
0.000144 mg/kg bwt/day and utilizes 2.9 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 RfD. 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.
    ii. 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 etremely 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. 
Further, a screening evaluation of leaching potential of a typical 
pyrethroid was conducted using EPA's Pesticide Root Zone Model (PRZM3). 
Based on this screening assessment, the potential concentrations of a 
pyrethroid in groundwater at depths of 1 and 2 meters are essentially 
zero (0.001 parts per billion(ppb)). Surface water concentrations for 
pyrethroids were estimated using PRZM3 and exposure Analysis Modeling 
System (EXAMS) using standard EPA cotton runoff and Mississippi pond 
scenarios. The maimum concentration predicted in the simulated pond was 
0.052 parts per billion. Concentrations in actual drinking water would 
be much lower than the levels predicted in the hypothetical, small, 
stagnant farm pond model since drinking water derived from surface 
water would normally be treated before consumption. Based on these 
analyses, the contribution of water to the dietary risk estimate is 
negligible. Therefore, FMC concludes that together these data indicate 
that residues are not epected to occur in drinking water.
    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 on August 
4, 1997 (62 FR 42020) (FRL-5734-6) and other EPA publications pursuant 
to the Food Quality Protection Act.

[[Page 67002]]

E. Safety Determination

    1. U.S. population. Based on a complete and reliable toxicology 
database, the RfD for zeta-cypermethrin is 0.005 mg/kg/day, based on a 
NOAEL of 1.0 mg/kg/day from the cypermethrin dog chronic study and an 
uncertainty factor of 200. Available information on anticipated 
residues, monitoring data and percent crop treated was incorporated 
into an analysis to estimate the Anticipated Residue Contribution (ARC) 
for 26 population subgroups. The ARC is generally considered a more 
realistic estimate than an estimate based on tolerance level residues. 
The ARC are estimated to be 0.000151 mg/kg body weight (bwt)/day and 
utilize 3.0 percent of the 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 0.000024 mg/kg bwt/
day and 0.000335 mg/kg bwt/day and utilizes 0.5 percent and 6.7 percent 
of the RfD, respectively. The ARC for children 1-6 years old and 
children 7-12 years old are estimated to be 0.000285 mg/kg bwt/day and 
0.000168 mg/kg bwt/day and utilizes 5.7 percent and 3.4 percent of the 
RfD, respectively. The ARC for females (13+/nursing) are estimated to 
be 0.000144 mg/kg bwt/day and utilizes 2.9 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 RfD. Therefore, 
FMC concludes that the chronic dietary risk of zeta-cypermethrin, as 
estimated by the aggregate risk assessment, does not appear to be of 
concern. For the purposes of assessing acute dietary risk for zeta-
cypermethrin, FMC has used the NOAEL of 10.0 mg/kg/day from the zeta-
cypermethrin acute neurotoxicity study in rats. 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 margins of exposure (MOE) are 
significantly greater than the EPA standard of 100 for all 
subpopulations. The 95th percentile of exposure for the overall U. S. 
population was estimated to be 0.000630 mg/kg/day (MOE of 15884); 99th 
percentile 0.002184 mg/kg/day (MOE of 4577); and 99.9th. percentile 
0.010260 mg/kg/day (MOE of 974). The 95th percentile of exposure for 
all infants  1 year old was estimated to be 0.000599 mg/kg/day (MOE of 
16682); 99th percentile 0.005656 mg/kg/day (MOE of 1768); and 99.9th 
percentile 0.029094 mg/kg/day (MOE of 343). The 95th percentile of 
exposure for nursing infants  1 year old was estimated to be 0.000172 
mg/kg/day (MOE of 58054); 99th percentile 0.000967 mg/kg/day (MOE of 
10336); and 99.9th percentile 0.004937 mg/kg/day (MOE of 2025). The 
95th percentile of exposure for non-nursing infants  1 year old (the 
most highly exposed population subgroup) was estimated to be 0.000760 
mg/kg/day (MOE of 13155); 99th percentile 0.011082 mg/kg/day (MOE of 
902); and 99.9th percentile 0.032957 mg/kg/day (MOE of 303). The 95th 
percentile of exposure for children 1 to 6 years old and children 7 to 
12 years old was estimated to be, respectively, 0.000936 mg/kg/day (MOE 
of 10681) and 0.000644 mg/kg/day (MOE of 15524); 99th percentile 
0.002768 mg/kg/day (MOE of 3612) and 0.001945 (MOE of 5141); and 99.9th 
percentile 0.012752 mg/kg/day (MOE of 784) and 0.006688 (MOE of 1495). 
The 95th percentile of exposure for females (13+/nursing) was estimated 
to be 0.000602 mg/kg/day (MOE of 16602); 99th percentile 0.002340 mg/
kg/day (MOE of 4273); and 99.9th percentile 0.011387 mg/kg/day (MOE of 
878). Therefore, FMC concludes that there is reasonable certainty that 
no harm will result from acute exposure to zeta-cypermethrin.
    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 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 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 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 no 
developmental (pup) or reproductive effects up to 45.0 mg/kg/day, 
highest dose tested.
    iv. Prenatal and postnatal sensitivity-- a. Prenatal. There was no 
evidence of developmental toxicity in the studies at the highest doses 
tested in the rat (35.0 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 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% 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 Codex, Canadian or Mexican residue limits for residues 
of zeta-cypermethrin in or on wheat (grain, forage, hay, straw, and 
bran), sorghum (grain, forage and fodder), tomatoes, peppers, peas and 
beans (dried, succulent and edible podded), and soybeans.

[[Page 67003]]

2. FMC Corporation

PP 1F3994

    EPA has received a pesticide petition PP 1F3994 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 tolerances for residues of the insecticide 
zeta-cypermethrin (-a-Cyano(3-phenoxyphenyl)methyl 
() cis, trans 3-(2,2-dichloroethenyl)-2,2-
dimethylcyclopropanecarboxylate) in or on the raw agricultural 
commodities (RAC): Sunflower, seeds at 0.20 ppm; sunflower, oil at 0.20 
ppm, poultry, meat at 0.05 ppm, poultry, meat by-products at 0.05 ppm, 
poultry, fat at 0.05 ppm and eggs at 0.05 ppm, meat of cattle, goats, 
hogs, horses, and sheep at 0.3 ppm, fat of cattle, goats, hogs, horses, 
and sheep at 2.0 ppm, and milk, fat at 1.0 ppm (reflecting 0.2 ppm in 
whole milk).

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. Crop field trial residue data from 
studies conducted at the maimum label rates for sunflowers show that 
the proposed zeta-cypermethrin tolerances on sunflower, seeds at 0.20 
ppm, sunflower, oil at 0.20 ppm.

B. Toxicological Profile

    1. Acute toxicity. For the purposes of assessing acute dietary 
risk, FMC has used the NOAEL of 0.5 mg/kg/day based on the NOAEL of 1.0 
mg/kg/day from the cypermethrin chronic toxicity study in dogs and a 
correction factor of two to account for the differences in the 
percentage of the biologically active isomer. The LOAEL of 5.0 mg/kg/
day was based on gastrointestinal disturbances observed in the first 
week of the study. This acute dietary endpoint is used to determine 
acute dietary risks to all population subgroups.
    2. Genotoxicty. The following genotoxicity tests were all negative: 
In vivo chromosomal aberration in rat bone marrow cells; in vitro 
cytogenic chromosome aberration; unscheduled DNA synthesis; 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 NAOEL 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 highest dose level tested.
    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 bwt gain. There were no signs of 
developmental toxicity at 700 mg/kg/day, the HDT.
    4. Subchronic toxicity. Short- and intermediate-term toxicity. The 
NOAEL of 2.5 mg/kg/day from the cypermethrin chronic toxicity study in 
dogs and a correction factor of two to account for the differences in 
the percentage of the biologically active isomer would also be used for 
short- and intermediate-term MOE calculations. The LOAEL of 7.5 mg/kg/
day was based on neurotoxic clinical signs which were displayed 
starting week one of the study.
    5. Chronic toxicity-- i. The reference dose (RfD) of 0.005 mg/kg/
day for zeta-cypermethrin is based on gastrointestinal disturbances in 
a cypermethrin study in dogs with an uncertainty factor of 200 (used to 
account for the differences in the percentage of the biologically 
active isomer).
    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 oidation.
    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 epression.
    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 eist for residues of zeta-cypermethrin on 
cottonseed; pecans; lettuce, head; onions, bulb; and cabbage and 
livestock commodities of cattle, goats, hogs, horses, and sheep (along 
with the associated meat and milk tolerances). For the purposes of 
assessing the potential dietary exposure for these eisting and the 
subject proposed tolerances, FMC has utilized available information on 
anticipated residues, monitoring data and percent crop treated as 
follows:
    a. 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 NOAEL of 0.5 mg/
kg/day based on the NOAEL of 1.0 mg/kg/day from the cypermethrin 
chronic toxicity study in dogs and a correction factor of two to 
account for the differences in the percentage of the biologically 
active isomer. The LOAEL of 5.0 mg/kg/day was based on gastrointestinal 
disturbances which were displayed during week one of this study. 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 margins 
of exposure (MOE) are significantly greater than the EPA standard of 
100 for all

[[Page 67004]]

subpopulations. The 95th percentile of exposure for the overall U. S. 
population was estimated to be 0.000330 mg/kg/day (MOE of 1514); 99th 
percentile 0.001136 mg/kg/day (MOE of 440); and 99.9th percentile 
0.002544 mg/kg/day (MOE of 196). The 95th percentile of exposure for 
all infants  1 year old was estimated to be 0.000096 mg/kg/day (MOE of 
5211); 99th percentile 0.000365 mg/kg/day (MOE of 1368); and 99.9th 
percentile 0.001438 mg/kg/day (MOE of 347). The 95th percentile of 
exposure for nursing infants  1 year old was estimated to be 0.000040 
mg/kg/day (MOE of 12532); 99th percentile 0.000194 mg/kg/day (MOE of 
2575); and 99.9th percentile 0.000899 mg/kg/day (MOE of 556). The 95th 
percentile of exposure for non-nursing infants  1 year old was 
estimated to be 0.000114 mg/kg/day (MOE of 4391); 99th percentile 
0.000437 mg/kg/day (MOE of 1144); and 99.9th percentile 0.001732 mg/kg/
day (MOE of 288). The 95th percentile of exposure for children 1 to 6 
years old (the most highly exposed population subgroup) and children 7 
to 12 years old was estimated to be, respectively, 0.000442 mg/kg/day 
(MOE of 1131) and 0.000413 mg/kg/day (MOE of 1209); 99th percentile 
0.001355 mg/kg/day (MOE of 368) and 0.001349 (MOE of 370); and 99.9th 
percentile 0.003454 mg/kg/day (MOE of 144) and 0.002928 (MOE of 170). 
The 95th percentile of exposure for females (13+/nursing) was estimated 
to be 0.000306 mg/kg/day (MOE of 1635); 99th percentile 0.001174 mg/kg/
day (MOE of 425); and 99.9th percentile 0.002583 mg/kg/day (MOE of 
193). 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.
    b. Chronic exposure and risk. The RfD of 0.005 mg/kg/day for zeta-
cypermethrin is based on gastrointestinal disturbances in a 
cypermethrin study in dogs with an uncertainty factor of 200 (used to 
account for the differences in the percentage of the biologically 
active isomer). A chronic dietary exposure/risk assessment has been 
performed for zeta-cypermethrin using the above 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 0.000033 mg/kg body weight (bwt)/day and 
utilize 0.7 percent of the RfD for the overall U. S. population. The 
ARC for nursing infants (1 year) and non-nursing infants (1 year) are 
estimated to be 0.000009 mg/kg bwt/day and 0.000035 mg/kg bwt/day and 
utilizes 0.2 percent and 0.7 percent of the RfD, respectively. The ARC 
for children 1-6 years old (subgroup most highly exposed) and children 
7-12 years old are estimated to be 0.000078 mg/kg bwt/day and 0.000052 
mg/kg bwt/day and utilizes 1.6 percent and 1.0 percent of the RfD, 
respectively. The ARC for females (13+/nursing) are estimated to be 
0.000033 mg/kg bwt/day and utilizes 0.7 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 RfD. 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.
    ii. 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 etremely 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. 
Further, a screening evaluation of leaching potential of a typical 
pyrethroid was conducted using EPA's Pesticide Root Zone Model (PRZM3). 
Based on this screening assessment, the potential concentrations of a 
pyrethroid in groundwater at depths of 1 and 2 meters are essentially 
zero (0.001 parts per billion (ppb)). Surface water concentrations for 
pyrethroids were estimated using PRZM3 and exposure Analysis Modeling 
System (EXAMS) using standard EPA cotton runoff and Mississippi pond 
scenarios. The maimum concentration predicted in the simulated pond was 
0.052 ppb. Concentrations in actual drinking water would be much lower 
than the levels predicted in the hypothetical, small, stagnant farm 
pond model since drinking water derived from surface water would 
normally be treated before consumption. Based on these analyses, the 
contribution of water to the dietary risk estimate is negligible. 
Therefore, FMC concludes that together these data indicate that 
residues are not epected to occur in drinking water.
    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 on August 
4, 1997 (62 FR 42020) (FRL-5734-6) and other EPA publications pursuant 
to the Food Quality Protection Act.

E. Safety Determination

    1. U.S. population. Based on a complete and reliable toxicology 
database, the RfD for zeta-cypermethrin is 0.005 mg/kg/day for zeta-
cypermethrin based on gastrointestinal disturbances in a cypermethrin 
study in dogs with an uncertainty factor of 200 (used to account for 
the differences in the percentage of the biologically active isomer). 
Available information on anticipated residues, monitoring data and 
percent crop treated was incorporated into an analysis to estimate the 
Anticipated Residue Contribution (ARC) for 26 population subgroups. The 
ARC is generally considered a more realistic estimate than an estimate 
based on tolerance level residues. The ARC are estimated to be 0.000033 
mg/kg body weight (bwt)/day and utilize 0.7 percent of the RfD for the 
overall U. S. population. The ARC for nursing infants (1 year) and non-
nursing infants (1 year) are estimated to be 0.000009 mg/kg bwt/day and 
0.000035 mg/kg bwt/day and utilizes 0.2 percent and 0.7 percent of the 
RfD, respectively. The ARC for children 1-6 years old (subgroup most 
highly exposed) and children 7-12 years old are estimated to be 
0.000078 mg/kg bwt/day and 0.000052 mg/kg bwt/day and utilizes 1.6 
percent and 1.0 percent of the RfD, respectively. The ARC for females 
(13+/nursing) are estimated to be 0.000033 mg/kg bwt/day and utilizes 
0.7 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 RfD. Therefore, FMC

[[Page 67005]]

concludes that the chronic dietary risk of zeta-cypermethrin, as 
estimated by the aggregate risk assessment, does not appear to be of 
concern.
    The 95th percentile of exposure for the overall U. S. population 
was estimated to be 0.000330 mg/kg/day (MOE of 1514); 99th percentile 
0.001136 mg/kg/day (MOE of 440); and 99.9th percentile 0.002544 mg/kg/
day (MOE of 196). The 95th percentile of exposure for all infants  1 
year old was estimated to be 0.000096 mg/kg/day (MOE of 5211); 99th 
percentile 0.000365 mg/kg/day (MOE of 1368); and 99.9th percentile 
0.001438 mg/kg/day (MOE of 347). The 95th percentile of exposure for 
nursing infants  1 year old was estimated to be 0.000040 mg/kg/day (MOE 
of 12532); 99th percentile 0.000194 mg/kg/day (MOE of 2575); and 99.9th 
percentile 0.000899 mg/kg/day (MOE of 556). The 95th percentile of 
exposure for non-nursing infants  1 year old was estimated to be 
0.000114 mg/kg/day (MOE of 4391); 99th percentile 0.000437 mg/kg/day 
(MOE of 1144); and 99.9th percentile 0.001732 mg/kg/day (MOE of 288). 
The 95th percentile of exposure for children 1 to 6 years old (the most 
highly exposed population subgroup) and children 7 to 12 years old was 
estimated to be, respectively, 0.000442 mg/kg/day (MOE of 1131) and 
0.000413 mg/kg/day (MOE of 1209); 99th percentile 0.001355 mg/kg/day 
(MOE of 368) and 0.001349 (MOE of 370); and 99.9th percentile 0.003454 
mg/kg/day (MOE of 144) and 0.002928 (MOE of 170). The 95th percentile 
of exposure for females (13+/nursing) was estimated to be 0.000306 mg/
kg/day (MOE of 1635); 99th percentile 0.001174 mg/kg/day (MOE of 425); 
and 99.9th percentile 0.002583 mg/kg/day (MOE of 193). Therefore, FMC 
concludes that there is reasonable certainty that no harm will result 
from acute exposure to zeta-cypermethrin.
    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 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 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 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 no 
developmental (pup) or reproductive effects up to 45.0 mg/kg/day, HDT.
    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 (35.0 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. 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.
    v. 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.

F. International Tolerances

    There are no Codex, Canadian, or Mexican residue limits for 
residues of zeta-cypermethrin in or on sunflowers.
[FR Doc. 00-28421 Filed 11-07-00; 8:45 am]
BILLING CODE 6560-50-S