[Federal Register Volume 64, Number 173 (Wednesday, September 8, 1999)]
[Notices]
[Pages 48829-48836]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-23198]


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ENVIRONMENTAL PROTECTION AGENCY

[PF-888; FRL-6097-6]


Notice of Filing a Pesticide Petition to Establish a Tolerance 
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 a pesticide 
petition 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-888, must be 
received on or before October 8, 1999.

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'' section. To 
ensure proper receipt by EPA, it is imperative that you identify docket 
control number PF-888 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, 401 M St., SW., Washington, DC 20460; telephone 
number: (703) 305-5428; and 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            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

[[Page 48830]]

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 in the ``FOR FURTHER INFORMATION CONTACT'' section.

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'' 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-888. 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 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-888 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, 401 M St., SW., 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 5.1/
6.1 or ASCII file format. All comments in electronic form must be 
identified by docket control number PF-888. 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 in the ``FOR FURTHER INFORMATION 
CONTACT'' section.

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 
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 supports granting of the petitions. Additional data 
may be needed before EPA rules on the petitions.

List of Subjects

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

Dated: August 23, 1999.

James Jones,

Director, Registration Division, Office of Pesticide Programs.

Summaries of Petitions

    Petitioner summaries of the pesticide petitions are printed below 
as required by section 408(d)(3) of the FFDCA. The summaries of the 
petitions were prepared by the petitioners and represent the views of 
the petitioners. EPA is publishing the petition summaries verbatim 
without editing them 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.


[[Page 48831]]



1. FMC Corporation

 PP 9F6037, 4F4399, and 4F3012

    EPA has received pesticide petitions (PP 9F6037, 4F4399, and 
4F3012) from FMC Corporation, 1735 Market Street, Philadelphia, PA 
19103 proposing, pursuant to section 408(d) of the Federal Food, Drug, 
and Cosmetic Act (FFDCA), 21 U.S.C. 346a(d), to amend 40 CFR part 180 
by establishing a tolerance for residues of zeta-cypermethrin 
(--cyano(3-phenoxyphenyl)methyl () 
cis, trans 3-(2,2-dichloroethenyl)-2,2-dimethylcyclopropanecarboxylate) 
in or on the raw agricultural commodity sugar beets, roots at 0.05 
parts per million (ppm), sugar beets, tops at 0.20 ppm; sugarcane at 
0.60 ppm; corn, grain (field, seed and pop) at 0.05 ppm; green onions 
at 6.0 ppm; alfalfa seed at 0.5 ppm; alfalfa forage at 10.0 ppm; and 
alfalfa hay at 30.0 ppm; and corn, sweet (K+CWHR) at 0.1 ppm; corn, 
forage and corn, fodder at 30.0 ppm; poultry, meat at 0.05 ppm; 
poultry, meat byproducts at 0.05 ppm; poultry, fat at 0.05 ppm; 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). EPA has determined that 
the petition contains data or information regarding the elements set 
forth in section 408(d)(2) of the FFDCA; however, EPA has not fully 
evaluated the sufficiency of the submitted data at this time or whether 
the data supports granting of the petition. Additional data may be 
needed before EPA rules on the petition.

A. Residue Chemistry

    1. Plant metabolism. The metabolism of cypermethrin in plants is 
adequately understood. Studies have been conducted to delineate the 
metabolism of radiolabelled cypermethrin in various crops all showing 
similar results. The residue of concern is the parent compound only.
    2. Analytical method. There is a practical analytical method for 
detecting and measuring levels of cypermethrin in or on food with a 
limit of detection that allows monitoring of food with residues at or 
above the levels set in these tolerances (Gas Chromatography with 
Electron Capture Detection (GC/ECD).
    3. Magnitude of residues. Crop field trial residue data from 
studies conducted at the maximum label rates for sugar beets, 
sugarcane, corn (field, seed, pop and sweet), green and bulb onions, 
and alfalfa, show that the proposed zeta-cypermethrin tolerances on 
sugar beets, roots at 0.05 ppm; sugar beets, tops at 0.20 ppm; 
sugarcane at 0.60 ppm; corn, grain (field, seed and pop) at 0.05 ppm; 
green onions at 6.0 ppm; alfalfa seed at 0.5 ppm, alfalfa forage at 
10.0 ppm, and alfalfa hay at 30.0 ppm; corn, sweet (K+CWHR) at 0.1 ppm, 
and corn, forage and corn, fodder at 30.0 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 has used the no observed adverse effect level (NOAEL) of 3.8 
milligrams/kilograms/day (mg/kg/day) based on the NOAEL of 7.5 mg/kg/
day from the cypermethrin chronic feeding/oncogenicity study in rats 
and a correction factor of two to account for the differences in the 
percentage of the biologically active isomer. The lowest observed 
adverse effect level (LOAEL) of 50.0 mg/kg/day was based on 
neurological signs which were displayed during week one of the study. 
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; CHO/
HGPTT mutagen assay; weakly mutagenic: gene mutation (Ames).
    3. Reproductive and developmental toxicity. No evidence of 
additional sensitivity to young rats was observed following 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 3.8 mg/kg/day based on the NOAEL 7.5 mg/kg/day from the 
cypermethrin chronic feeding/oncogenicity study in rats and a 
correction factor of two to account for the biologically active isomer 
would also be used for short- and intermediate-term MOE calculations 
(as well as acute, discussed in (1) above). The LOAEL of 50.0 mg/kg/day 
was based on neurological signs which were displayed during week one of 
the study.
    5. Chronic toxicity-- i. The reference dose (RfD) of 0.0125 mg/kg/
day for zeta-cypermethrin is based on a NOAEL of 2.5 mg/kg/day from a 
cypermethrin rat reproduction 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 consistent decreased body weight gain in both sexes at the LOAEL of 
7.5 mg/kg/day.
    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.
    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 
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

[[Page 48832]]

assessing the potential dietary exposure for these existing and the 
subject proposed tolerances, FMC has utilized available information on 
anticipated residues, monitoring data and percent crop treated (PCT) 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 has used the 
NOAEL of 3.8 mg/kg/day based on the NOAEL of 7.5 mg/kg/day from the 
cypermethrin chronic feeding/oncogenicity study in rats and a 
correction factor of two to account for the differences in the 
percentage of the biologically active isomer. The LOAEL of 50.0 mg/kg/
day was based on neurological signs 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 PCT 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 0.001934 mg/kg/day 
(MOE of 1964); 99th percentile 0.003844 mg/kg/day (MOE of 988); and 
99.9th percentile 0.012574 mg/kg/day (MOE of 302). The 95th percentile 
of exposure for all infants < 1 year old was estimated to be 0.002195 
mg/kg/day (MOE of 1730); 99th percentile 0.004976 mg/kg/day (MOE of 
763); and 99.9th percentile 0.016942 mg/kg/day (MOE of 224). The 95th 
percentile of exposure for nursing infants < 1 year old was estimated 
to be 0.001090 mg/kg/day (MOE of 3484); 99th percentile 0.002516 mg/kg/
day (MOE of 1510); and 99.9th percentile 0.004140 mg/kg/day (MOE of 
917). The 95th percentile of exposure for non-nursing infants < 1 year 
old was estimated to be 0.002288 mg/kg/day (MOE of 1660); 99th 
percentile 0.006164 mg/kg/day (MOE of 616); and 99.9th percentile 
0.018741 mg/kg/day (MOE of 202). 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, 
0.002993 mg/kg/day (MOE of 1269) and 0.002286 mg/kg/day (MOE of 1662); 
99th percentile 0.005234 mg/kg/day (MOE of 725) and 0.004178 (MOE of 
909); and 99.9th percentile 0.034965 mg/kg/day (MOE of 108) and 
0.014545 (MOE of 261). The 95th percentile of exposure for females 
(13+/nursing) was estimated to be 0.001448 mg/kg/day (MOE of 2623); 
99th percentile 0.003594 mg/kg/day (MOE of 1057); and 99.9th percentile 
0.011663 mg/kg/day (MOE of 325). Therefore, FMC concludes that the 
acute dietary risk of zeta-cypermethrin, as estimated by the dietary 
risk assessment, does not appear to be of concern.
    iii. Chronic exposure and risk. The RfD of 0.0125 mg/kg/day for 
zeta-cypermethrin is based on a NOAEL of 2.5 mg/kg/day from a 
cypermethrin rat reproduction 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 consistent decreased body weight gain in both sexes at the LOAEL of 
7.5 mg/kg/day. A chronic dietary exposure/risk assessment has been 
performed for zeta-cypermethrin using the above RfD. Available 
information on anticipated residues, monitoring data and PCT 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 0.000379 mg/kg body weight (bwt)/day and utilizes 3.0% 
of the RfD for the overall U. S. population. The ARC for nursing 
infants (<1 year) and non-nursing infants (< 1 year) is estimated to be 
0.000104 mg/kg bwt/day and 0.000509 mg/kg bwt/day and utilizes 0.8% and 
4.1% of the RfD, respectively. The ARC for children 1-6 years old 
(subgroup most highly exposed) and children 7-12 years old is estimated 
to be 0.000904 mg/kg bwt/day and 0.000544 mg/kg bwt/day and utilizes 
7.2% and 4.4% of the RfD, respectively. The ARC for females (13+/
nursing) is estimated to be 0.000365 mg/kg bwt/day and utilizes 2.9% 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% 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.
    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 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 ground water at depths of 1 and 2 meters are essentially 
zero (<0.001 parts per billion). 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 maximum 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 expected 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 in the 
Federal Register of 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 
data base, the RfD for zeta-cypermethrin is 0.0125 mg/kg/day, based on 
a NOAEL of

[[Page 48833]]

2.5 mg/kg/day and a LOAEL of 7.5 mg/kg/day from the cypermethrin rat 
reproduction study and an uncertainty factor of 200. Available 
information on anticipated residues, monitoring data and PCT was 
incorporated into an analysis to estimate the ARC for 26 population 
subgroups. The ARC is generally considered a more realistic estimate 
than an estimate based on tolerance level residues. The ARC is 
estimated to be 0.000379 mg/kg body weight (bwt)/day and utilizes 3.0% 
of the RfD for the overall U. S. population. The ARC for nursing 
infants (<1 year) and non-nursing infants (<1 year) is estimated to be 
0.000104 mg/kg bwt/day and 0.000509 mg/kg bwt/day and utilizes 0.8% and 
4.1% 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 0.000904 mg/kg bwt/day and 0.000544 mg/kg bwt/day and 
utilizes 7.2% and 4.4% of the RfD, respectively. The ARC for females 
(13+/nursing) is estimated to be 0.000365 mg/kg bwt/day and utilizes 
2.9% 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% 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.
    The 95th percentile of exposure for the overall U. S. population 
was estimated to be 0.001934 mg/kg/day (MOE of 1964); 99th percentile 
0.003844 mg/kg/day (MOE of 988); and 99.9th percentile 0.012574 mg/kg/
day (MOE of 302). The 95th percentile of exposure for all infants < 1 
year old was estimated to be 0.002195 mg/kg/day (MOE of 1730); 99th 
percentile 0.004976 mg/kg/day (MOE of 763); and 99.9th percentile 
0.016942 mg/kg/day (MOE of 224). The 95th percentile of exposure for 
nursing infants < 1 year old was estimated to be 0.001090 mg/kg/day 
(MOE of 3484); 99th percentile 0.002516 mg/kg/day (MOE of 1510); and 
99.9th percentile 0.004140 mg/kg/day (MOE of 917). The 95th percentile 
of exposure for non-nursing infants < 1 year old was estimated to be 
0.002288 mg/kg/day (MOE of 1660); 99th percentile 0.006164 mg/kg/day 
(MOE of 616); and 99.9th percentile 0.018741 mg/kg/day (MOE of 202). 
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, 0.002993 mg/kg/day (MOE of 1269) and 
0.002286 mg/kg/day (MOE of 1662); 99th percentile 0.005234 mg/kg/day 
(MOE of 725) and 0.004178 (MOE of 909); and 99.9th percentile 0.034965 
mg/kg/day (MOE of 108) and 0.014545 (MOE of 261). The 95th percentile 
of exposure for females (13+/nursing) was estimated to be 0.001448 mg/
kg/day (MOE of 2623); 99th percentile 0.003594 mg/kg/day (MOE of 1057); 
and 99.9th percentile 0.011663 mg/kg/day (MOE of 325). 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 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 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. 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.
    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 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 sugar beets, sugarcane, corn 
(field, seed, pop and sweet), green and bulb onions, and alfalfa.

2. FMC Corporation

 PP 9F6040

     EPA has received a pesticide petition (PP 9F6040) from FMC 
Corporation, 1735 Market Street, Philadelphia, PA 19103 proposing, 
pursuant to section 408(d) of the Federal Food, Drug, and Cosmetic Act 
(FFDCA), 21 U.S.C. 346a(d), to amend 40 CFR part 180 by establishing a 
tolerance for residues of zeta-cypermethrin (--
cyano(3-phenoxyphenyl)methyl () cis, trans 3-(2,2-
dichloroethenyl)-2,2-dimethylcyclopropanecarboxylate) in or on the raw 
agricultural commodity rice, grain at 1.2 ppm; rice, straw at 2.0 ppm; 
and rice, hulls at 16.0 ppm. EPA has determined that the petition 
contains data or information regarding the elements set forth in 
section 408(d)(2) of the FFDCA; however, EPA has not fully evaluated 
the sufficiency of the submitted data at this time or whether the data 
supports granting of the petition. Additional data may be needed before 
EPA rules on the petition.

[[Page 48834]]

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 maximum label rates for rice grain show that 
the proposed zeta-cypermethrin tolerances on rice, grain at 1.2 ppm, 
rice, straw at 2.0 ppm and rice, hulls at 16.0 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 has used the NOAEL of 3.8 mg/kg/day based on the NOAEL of 7.5 
mg/kg/day from the cypermethrin chronic feeding/oncogenicity study in 
rats and a correction factor of two to account for the differences in 
the percentage of the biologically active isomer. The LOAEL) of 50.0 
mg/kg/day was based on neurological signs which were displayed during 
week one of the study. 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; CHO/
HGPTT mutagen assay; weakly mutagenic: gene mutation (Ames).
    3. Reproductive and developmental toxicity. No evidence of 
additional sensitivity to young rats was observed following 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 3.8 mg/kg/day based on the NOAEL 7.5 mg/kg/day from the 
cypermethrin chronic feeding/oncogenicity study in rats and a 
correction factor of two to account for the biologically active isomer 
would also be used for short- and intermediate-term MOE calculations 
(as well as acute, discussed in (1) above). The LOAEL of 50.0 mg/kg/day 
was based on neurological signs which were displayed during week one of 
the study.
    5.  Chronic toxicity-- i. The RfD of 0.0125 mg/kg/day for zeta-
cypermethrin is based on a NOAEL of 2.5 mg/kg/day from a cypermethrin 
rat reproduction 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 consistent 
decreased body weight gain in both sexes at the LOAEL of 7.5 mg/kg/day.
    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.
    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 
cottonseed; pecans; lettuce, head; onions, bulb; and cabbage and 
livestock commodities of cattle, goats, hogs, horses, and sheep (and 
their associated meat and milk tolerances). For the purposes of 
assessing the potential dietary exposure for these existing and the 
subject proposed tolerances, FMC has utilized available information on 
anticipated residues, monitoring data and PCT 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 has used the 
NOAEL of 3.8 mg/kg/day based on the NOAEL of 7.5 mg/kg/day from the 
cypermethrin chronic feeding/oncogenicity study in rats and a 
correction factor of two to account for the differences in the 
percentage of the biologically active isomer. The LOAEL of 50.0 mg/kg/
day was based on neurological signs 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 PCT 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 0.001049 mg/kg/day 
(MOE of 3622); 99th percentile 0.003166 mg/kg/day (MOE of 1200); and 
99.9th percentile 0.012313 mg/kg/day (MOE of 308). The 95th percentile 
of exposure for all infants < 1 year old was estimated to be 0.000610 
mg/kg/day (MOE of 6229); 99th percentile 0.001955 mg/kg/day (MOE of 
1943); and 99.9th percentile 0.019362 mg/kg/day (MOE of 196). The 95th 
percentile of exposure for nursing infants < 1 year old was estimated 
to be 0.000283 mg/kg/day (MOE of 13418); 99th percentile 0.001141 mg/
kg/day

[[Page 48835]]

(MOE of 3330); and 99.9th percentile 0.002424 mg/kg/day (MOE of 1567). 
The 95th percentile of exposure for non-nursing infants < 1 year old 
was estimated to be 0.000657 mg/kg/day (MOE of 5784); 99th percentile 
0.007700 mg/kg/day (MOE of 493); and 99.9th percentile 0.019395 mg/kg/
day (MOE of 195). 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, 0.001184 mg/kg/day 
(MOE of 3208) and 0.001177 mg/kg/day (MOE of 3227); 99th percentile 
0.003894 mg/kg/day (MOE of 975) and 0.003337 (MOE of 1138); and 99.9th 
percentile 0.034204 mg/kg/day (MOE of 111) and 0.013940 (MOE of 272). 
The 95th percentile of exposure for females (13+/nursing) was estimated 
to be 0.001070 mg/kg/day (MOE of 3549); 99th percentile 0.003318 mg/kg/
day (MOE of 1145); and 99.9th percentile 0.011127 mg/kg/day (MOE of 
341). Therefore, FMC concludes that the acute dietary risk of zeta-
cypermethrin, as estimated by the dietary risk assessment, does not 
appear to be of concern.
    iii. Chronic exposure and risk. The RfD of 0.0125 mg/kg/day for 
zeta-cypermethrin is based on a NOAEL of 2.5 mg/kg/day from a 
cypermethrin rat reproduction 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 consistent decreased body weight gain in both sexes at the LOAEL of 
7.5 mg/kg/day. A chronic dietary exposure/risk assessment has been 
performed for zeta-cypermethrin using the above RfD. Available 
information on anticipated residues, monitoring data and PCT 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 0.000158 mg/kg 
body weight (bwt)/day and utilizes 1.3% of the RfD for the overall U. 
S. population. The ARC for non-nursing infants (<1 year) and nursing 
infants (<1 year) is estimated to be 0.000212 mg/kg/day and 0.000032 
mg/kg/day and utilizes 1.7% and 0.3% of the RfD, respectively. The ARC 
for children 1-6 years old (subgroup most highly exposed) and children 
7-12 years old is estimated to be 0.000268 mg/kg bwt/day and 0.000168 
mg/kg bwt/day and utilizes 2.1% and 1.3% of the RfD, respectively. The 
ARC for females (13+/nursing) is estimated to be 0.000170 mg/kg bwt/day 
and utilizes 1.4% 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% 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.
    vi. 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 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 ground water at depths of 1 and 2 meters are essentially 
zero (<0.001 parts per billion). 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 maximum 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 expected 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 in Federal 
Register August 4, 1997 (62 FR 42020) 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 
data base, the RfD for zeta-cypermethrin is 0.0125 mg/kg/day, based on 
a NOAEL of 2.5 mg/kg/day and a LOAEL of 7.5 mg/kg/day from the 
cypermethrin rat reproduction study and an uncertainty factor of 200. 
Available information on anticipated residues, monitoring data and PCT 
was incorporated into an analysis to estimate the ARC for 26 population 
subgroups. The ARC is generally considered a more realistic estimate 
than an estimate based on tolerance level residues. The ARC is 
estimated to be 0.000158 mg/kg body weight (bwt)/day and utilizes 1.3% 
of the RfD for the overall U. S. population. The ARC for non-nursing 
infants (<1 year) and nursing infants (<1 year) is estimated to be 
0.000212 mg/kg/day and 0.000032 mg/kg/day and utilizes 1.7% and 0.3% of 
the RfD, respectively. The ARC for children 1-6 years old (subgroup 
most highly exposed) and children 7-12 years old is estimated to be 
0.000268 mg/kg bwt/day and 0.000168 mg/kg bwt/day and utilizes 2.1% and 
1.3% of the RfD, respectively. The ARC for females (13+/nursing) is 
estimated to be 0.000170 mg/kg bwt/day and utilizes 1.4% 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% 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.
    The 95th percentile of exposure for the overall U. S. population 
was estimated to be 0.001049 mg/kg/day (MOE of 3622); 99th percentile 
0.003166 mg/kg/day (MOE of 1200); and 99.9th percentile 0.012313 mg/kg/
day (MOE of 308). The 95th percentile of exposure for all infants < 1 
year old was estimated to be 0.000610 mg/kg/day (MOE of 6229); 99th 
percentile 0.001955 mg/kg/day (MOE of 1943); and 99.9th percentile 
0.019362 mg/kg/day (MOE of 196). The 95th percentile of exposure for 
nursing infants < 1 year old was estimated to be 0.000283 mg/kg/day 
(MOE of 13418); 99th percentile 0.001141 mg/kg/day (MOE of 3330); and 
99.9th percentile 0.002424 mg/kg/day (MOE of 1567). The 95th percentile 
of

[[Page 48836]]

exposure for non-nursing infants < 1 year old was estimated to be 
0.000657 mg/kg/day (MOE of 5784); 99th percentile 0.007700 mg/kg/day 
(MOE of 493); and 99.9th percentile 0.019395 mg/kg/day (MOE of 195). 
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, 0.001184 mg/kg/day (MOE of 3208) and 
0.001177 mg/kg/day (MOE of 3227); 99th percentile 0.003894 mg/kg/day 
(MOE of 975) and 0.003337 (MOE of 1138); and 99.9th percentile 0.034204 
mg/kg/day (MOE of 111) and 0.013940 (MOE of 272). The 95th percentile 
of exposure for females (13+/nursing) was estimated to be 0.001070 mg/
kg/day (MOE of 3549); 99th percentile 0.003318 mg/kg/day (MOE of 1145); 
and 99.9th percentile 0.011127 mg/kg/day (MOE of 341). 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 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 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. 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.
    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 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 rice grain, straw or hulls.

[FR Doc. 99-23198 Filed 9-7-99; 8:45 am]
BILLING CODE 6560-50-F