[Federal Register Volume 62, Number 29 (Wednesday, February 12, 1997)]
[Notices]
[Pages 6530-6534]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-3225]


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ENVIRONMENTAL PROTECTION AGENCY
[PF-702; FRL-5586-3]


Valent U.S.A. Corporation; Pesticide Tolerance Petition Filing

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice of filing.

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SUMMARY: This notice announces the filing of a pesticide petition 
proposing the establishment of a regulation for residues of the 
herbicide clethodim in or on tomato, alfalfa, dry bean, and peanut 
commodities. The summary of the petition was prepared by the 
petitioner, Valent U.S.A. Corporation (Valent).

DATES: Comments, identified by the docket control number [PF-702], must 
be received on or before, March 13, 1997.

ADDRESSES: By mail, submit written comments to Public Response and 
Program Resources Branch Field Operations Division (7506C), Office of 
Pesticide Programs, Environmental Protection Agency, 401 M St., S.W., 
Washington, DC 20460. In person, bring comments to Rm. 1132, CM #2, 
1921 Jefferson Davis Highway, Arlington, VA. Comments and data may also 
be submitted electronically by sending electronic mail (e-mail) to: 
[email protected]. Electronic comments on this notice may be 
filed online at many Federal Depository Libraries. Additional 
information on electronic submissions can be found in unit II. of this 
document.
    Information submitted as comments concerning this document may be 
claimed confidential by marking any part or all of that information as 
``Confidential Business Information'' (CBI). CBI should not be 
submitted through e-mail. Information marked as CBI will not be 
disclosed except in accordance with procedures set forth in 40 CFR part 
2. A copy of the comment that does not contain CBI must be submitted 
for inclusion in the public record. Information not marked confidential 
may be disclosed publicly by EPA without prior notice. All written 
comments will be available for public inspection in Rm. 1132 at the 
address given above, from 8:30 a.m. to 4 p.m., Monday through Friday, 
excluding legal holidays.

FOR FURTHER INFORMATION CONTACT: By mail: Joanne I. Miller, Product 
Manager (PM) 23; Registration Division (7505C), Environmental 
Protection Agency, 401 M St., SW., Washington, DC 20460. Office 
location, telephone number, and e-mail address: Rm. 237, CM #2, 1921 
Jefferson Davis Highway, Arlington, VA; (703) 305-6224; e-mail: 
[email protected].

SUPPLEMENTARY INFORMATION: EPA has received pesticide petitions (PP 
5F4572 and PP 5F4440) from Valent U.S.A. Corporation, 1333 N. 
California Blvd., Walnut Creek, CA 94596 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 tolerances for 
residues of the herbicide clethodim in or on the following raw or 
processed agricultural commodities: tomatoes at 1.0 part per million 
(ppm); tomato puree at 2.0 ppm; tomato paste at 3.0 ppm; alfalfa forage 
at 6.0 ppm; alfalfa hay at 10.0 ppm; peanut nutmeat at 3.0 ppm; peanut 
hay at 3.0 ppm; peanut meal at 5.0 ppm; and dry bean seeds at 2.0 ppm. 
The proposed enforcement analytical method for these commodities is 
EPA-RM-26D-3, a high-performance liquid chromatography (HPLC) method. 
EPA has determined that the petition contains data or information 
regarding the elements set forth in section 408(d)(2); however, EPA has 
not fully evaluated the sufficiency of the submitted data at this time 
or whether the data supports granting of the petitions. Additional data 
may be needed before EPA rules on the petitions.

[[Page 6531]]

    As required by section 408(d) of the FFDCA, as recently amended by 
the Food Quality Protection Act (FQPA) (Pub L. 104-170), Valent 
included in the petitions a summary of the petitions and authorization 
for the summary to be published in the Federal Register in a notice of 
receipt of the petitions. The summary represents the views of Valent; 
EPA is in the process of evaluating the petitions. As required by 
section 408(d)(3) EPA is including the summary as a part of this notice 
of filing. EPA may have made minor edits to the summary for the purpose 
of clarity.

I. Petition Summary

A. Residue Chemistry

    1. Plant metabolism. Clethodim is used for postemergent control of 
grasses in a wide variety of crops including cotton, soybeans, sugar 
beets, onions, etc. Plant metabolism studies have been performed in 
carrots, soybeans, and cotton. Studies were performed with clethodim 
radio-labeled in the ring structure and in the side chain to follow 
both parts of the molecule.
    The major metabolic pathway in plants is initial sulfoxidation to 
form clethodim sulfoxide followed by further sulfoxidation to form 
clethodim sulfone; elimination of the chloroallyloxy side chain to give 
the imine sulfoxide and sulfone; and hydroxylation to form the 5-OH 
sulfoxide and 5-OH sulfone. Clethodim sulfoxide and clethodim sulfone 
conjugates were also detected as major or minor metabolites, depending 
on plant species and subfractions. Once cleaved from clethodim, the 
chloroallyloxy moiety undergoes extensive metabolism to eliminate the 
chlorine atom and incorporate the three-carbon moieties into natural 
plant components. EPA has determined that the nature of the residue is 
adequately understood for the purposes of this petition (memos from J. 
Morales, February 8, 1996 and June 25, 1996).
    Based on these metabolism studies, the residues of concern in crops 
are clethodim and its metabolites containing the cyclohexene moiety, 
and their sulfoxides and sulfones.
    2. Analytical methods. Adequate analytical methodology is available 
for detecting and measuring levels of clethodim and its metabolites in 
crops. For most commodities, the primary enforcement method is EPA-RM-
26D-3, an HPLC method capable of distinguishing clethodim from the 
structurally related herbicide sethoxydim. However, for milk natural 
interferences prevent adequate quantitation of clethodim moieties and 
the common-moiety method (RM-26B-2) is the primary enforcement method 
with EPA-RM-26D-3 as the secondary method if needed to determine 
whether residues are clethodim or sethoxydim. Both of these methods 
have successfully undergone petition method validations at EPA.
    3. Magnitude of residues. Clethodim is the active ingredient in 
SELECT 2 EC Herbicide (EPA Reg. No. 59639-3) and SELECT Herbicide (also 
known as PRISM and ENVOY Herbicides, EPA Reg. No. 59639-78). Tolerances 
have been established for residues in cotton, soybean, sugar beet, 
onion (dry bulb), and animal commodities. A summary of available field 
residue data for the pending tolerances on tomato, alfalfa, peanut, and 
dry bean commodities is presented below.
    In 12 field trials, tomatoes were treated with two post-emergent 
applications of 0.25 lb. a.i./A each, approximately 14 days apart, and 
harvested approximately 20 days after the last application. Both fresh 
and processing tomatoes were included and trials were performed in EPA 
growing regions 1, 2, 3, 5, and 10. Residues for individual tomato 
fruit samples ranged from < 0.1 ppm to 0.82 ppm. The highest average 
field trial (HAFT) residue was 0.77 ppm. The average residue value for 
all trials, excluding samples less than the limit of detection, was 
0.37 ppm. Two processing studies were also performed for tomatoes. 
Residues were found to concentrate in puree and paste. Concentration 
factors were determined to be 2.2 for puree and 3.25 for paste. These 
data have been reviewed by EPA and support time-limited tolerances of 
1.0 ppm in tomato fruit, 2.0 ppm in puree, and 3.0 in paste. Valent has 
agreed to conduct four additional residue trials in growing region 10 
as a condition of registration in order to meet recent Agency guidance 
for distribution of crop field trials across the United States.
    In 12 field trials, alfalfa was treated with two post-emergent 
applications of 0.25 lb. a.i./A each. Alfalfa was harvested 
approximately 15 to 20 days after each application. Forage samples were 
taken immediately after cutting and hay samples were dried in the field 
for 1 to 10 days before being collected. Trials were performed in EPA 
growing regions 1, 5, 7, 10 and 11. Residues for individual forage 
samples, treated with either one or two applications, ranged from 0.13 
ppm to 5.7 ppm. The highest average field trial (HAFT) residue was 5.4 
ppm. Hay sample residues ranged from 0.45 ppm to 9.2 ppm. The HAFT 
residue was 8.9 ppm. These data have been reviewed by the EPA and 
support tolerances of 6.0 ppm in alfalfa forage and 10.0 ppm in hay.
    In 8 field trials, peanuts were treated with two post-emergent 
applications of 0.25 lb. a.i./A each approximately 14 days apart and 
harvested approximately 40 days after the last application. Trials were 
performed in EPA growing regions 2, 3, and 8. Harvested peanuts were 
dried in the field for 3 to 11 days after which peanuts and peanut hay 
were sampled. Residues for individual peanut nutmeat samples ranged 
from < 0.05 ppm to 2.7 ppm. The highest average field trial (HAFT) 
residue was 1.75 ppm. The average residue value for all trials, 
excluding samples less than the limit of detection, was 0.94 ppm. 
Residues in peanut hay ranged from 0.22 ppm to 2.6 ppm with a HAFT 
residue of 2.55 ppm. A processing study was also performed for peanuts 
and residues were found to concentrate in meal with a concentration 
factor of 3.0. These data have been reviewed by the EPA and support 
tolerances of 3.0 ppm in peanut nutmeat, 3.0 ppm in peanut hay, and 5.0 
ppm in peanut meal. Valent has agreed to conduct four additional 
residue trials in growing region 2 as a condition of registration in 
order to meet recent Agency guidance for distribution of crop field 
trials across the United States.
    In 9 field trials, dry beans were treated with two post-emergent 
applications of 0.25 lb. a.i./A each approximately 14 days apart and 
harvested approximately 30 days after the last application. Trials were 
performed in EPA growing regions 5, 7, 9, 10, and 11. Residues for 
individual dry bean seed samples ranged from 0.58 ppm to 1.6 ppm. The 
highest average field trial (HAFT) residue was 1.6 ppm. The average 
residue value for all trials, excluding samples less than the limit of 
detection, was 0.99 ppm. These data have been reviewed by the EPA and 
support a tolerance of 2.0 ppm for dry bean seeds. Valent has agreed to 
conduct three additional residue trials in growing region 5 as a 
condition of registration in order to meet recent Agency guidance for 
distribution of crop field trials across the United States.

B. Toxicological Profile

    1. Acute toxicity. Clethodim Technical is slightly toxic to animals 
following acute oral (Toxicity Category III), dermal (Toxicity Category 
IV), or inhalation exposure (Toxicity Category IV under current 
guideline interpretation). Clethodim is a moderate eye irritant 
(Category III), a severe skin irritant (Category II), and does not 
cause skin sensitization in the modified Buehler test in guinea pigs. 
In addition, an acute oral no-observed effect level

[[Page 6532]]

(NOEL) has been determined in rats to be 300 mg/kg. Since this NOEL is 
significantly higher than the lowest chronic NOEL of 1 mg/kg/day, 
chronic exposures are expected to be of the most concern and this 
summary will focus on repeated exposures.
    2. Genotoxicity. Clethodim Technical did not induce gene mutation 
in microbial in vitro assays. A weak response in an in vitro assay for 
chromosome aberrations was not confirmed when clethodim was tested in 
an in vivo cytogenetics assay up to the maximally tolerated dose level, 
nor was the response observed in vitro using technical material of a 
higher purity. No evidence of unscheduled DNA synthesis was seen 
following in vivo exposure up to a dose level near the LD50 (1.5 
g/kg). This evidence indicates that clethodim does not present a 
genetic hazard to intact animal systems.
    3. Reproductive and developmental toxicity. No reproductive 
toxicity was observed with Clethodim Technical at feeding levels up to 
2,500 ppm. Developmental toxicity was observed in two rodent species, 
but only at maternally toxic dose levels. In rats, the developmental 
NOEL was 300 mg/kg/day while the maternal toxicity NOEL was only 150 
mg/kg/day. In rabbits, the developmental NOEL was 300 mg/kg/day and the 
maternal NOEL was only 25 mg/kg/day. Thus, Valent believes that 
clethodim should therefore not be considered a reproductive or 
developmental hazard.
    4. Subchronic toxicity. High doses of Clethodim Technical cause 
decreased body weights, increased liver size (increased weight and cell 
hypertrophy), and anemia (decreased erythrocyte counts, hemoglobin, or 
hematocrit) in rats and dogs. No observable effect levels have been 
determined to be 100 mg/kg/day for a 4-week dermal study in rats, 200 
to 1,000 ppm for 4- or 5-week feeding studies in rats or mice, 500 ppm 
in a 13-week feeding study in rats, and 25 mg/kg/day in a 90-day oral 
study in dogs.
    5. Chronic toxicity and oncogenicity. In chronic studies conducted 
in rats, mice, and dogs, compound-related effects noted at high doses 
included decreased body weight, increased liver size (liver weight and 
hypertrophy), and anemia (decreased hemoglobin, hematocrit, and 
erythrocyte count). Bone marrow hyperplasia was observed in dogs at the 
highest dose tested. No treatment-related increases in incidence of 
neoplasms were observed in any study. Chronic NOELs were 200 ppm for an 
18-month feeding study in mice and 500 ppm for a 24-month study in 
rats. The lowest NOEL is from the 1-year oral dog study and is 1 mg/kg/
day clethodim technical. Based on this study and a 100-fold safety 
factor, the Reference Dose (RfD) for clethodim was determined to be 
0.01 mg/kg/day. Valent believes that Clethodim is not carcinogenic.
    6. Rat metabolism. The in vivo metabolism of clethodim in rats was 
tested at a high dose (468 mg/kg), low dose (4.4 mg/kg), and a low dose 
(4.8 mg/kg) following 14 days of treatment with Clethodim Technical. A 
single oral dose of [14C]-clethodim was given to each rat and expired 
carbon dioxide and excreta were collected over the next two and seven 
days, respectively, to determine radio-label recovery. Several organs 
and tissues, and the remaining carcass, were collected after sacrifice 
to determine radio-label recovery. In all treatment groups, nearly all 
of the radio-label was eliminated in the urine (87-93%), feces (9-17%), 
and carbon dioxide (0.5-1%) and less than 1% of the dose was recovered 
in the organs and tissues after seven days.
    Elimination was rapid as most of the recovered dose was eliminated 
within 48 hours. The low dose groups eliminated clethodim slightly 
faster than the high dose group, and repeated exposure to clethodim 
prior to radio-label dosing did not affect the rate of elimination or 
distribution of recovered radio-label. There were no apparent sex 
differences with respect to elimination or distribution of metabolites.
    The primary excretory metabolites were identified as clethodim 
sulfoxide (48-63%), clethodim S-methyl sulfoxide (6-12%), clethodim 
imine sulfoxide (7-10%), and clethodim 5-hydroxy sulfoxide (3-5%). 
Minor metabolites included clethodim oxazole sulfoxide (2-3%), 
clethodim trione sulfoxide (1%), clethodim (1%), clethodim 5-hydroxy 
sulfone (0.3-1%), clethodim sulfone (0.1-1%), aromatic sulfone (0.2-
0.7%), and S-methyl sulfone (0-0.4%).
    7. Dermal penetration. The dermal penetration of SELECT 2 EC 
Herbicide, the end-use product, was tested on unabraded, shaved skin of 
rats. Single doses of approximately 0.05, 0.5, and 5.0 mg of radio-
labeled (14C-clethodim) SELECT 2 EC Herbicide, were applied topically 
to 10 cm2 sites on the dorsal trunk. After 2, 10, or 24 hours, urine, 
feces, volatiles, scrubbings of the skin, skin at treatment site, 
blood, several tissues, and the carcass were collected and counted for 
radioactivity. Clethodim was found to be slowly absorbed through the 
skin in a time-dependent manner. The percent of dose absorbed increased 
with length of exposure and decreased with increasing dose. Ten-hour 
absorption rates ranged from 7.5% to 30.0%. Most of the absorbed 
material was found in the urine and carcass, and most of the unabsorbed 
material was found in the skin scrubbings indicating that material was 
still on the skin surface.
    8. Metabolite toxicity. Two metabolites of clethodim, clethodim 
imine sulfone (RE-47719) and clethodim 5-hydroxy sulfone (RE-51228), 
have been tested in toxicity screening studies to evaluate the 
potential impact of these metabolites on the toxicity of clethodim. In 
general, these metabolites were found to be less toxic than Clethodim 
Technical for acute and oral toxicity studies; reproduction and 
teratology screening studies; and several mutagenicity studies.

C. Aggregate Exposure

    1. Dietary exposure--a. Food. Clethodim is approved for use in the 
production of commercial agricultural crops including cotton, soybeans, 
sugar beets, and onions (dry bulb). Dietary exposures are expected to 
represent the major route of exposure to the public. Since chronic 
exposures are of more concern than acute exposures for clethodim, this 
summary will focus primarily on chronic issues. Chronic dietary 
assessments for clethodim have been conducted recently by EPA and 
Valent to address the new tolerances proposed for tomato, alfalfa, 
peanut, and dry bean commodities.
    In the EPA assessment (memo from Brian Steinwand dated June 28, 
1996), anticipated residues were used for soybean, cotton, and animal 
commodities. For all other crops, tolerance values were used which 
overestimate potential exposure. The assessment assumed 100% of all 
crops were treated with clethodim which also overestimates exposure. 
The results of this conservative assessment are summarized in the 
Safety Determination section of this document and indicate that chronic 
dietary exposures for existing and proposed uses of clethodim are less 
than the reference dose.
    In Valent's assessment, anticipated residues were used for all crop 
and animal commodities. Anticipated residue levels were the mean levels 
found in crop field trial data after treatment with the maximum 
recommended rate and harvested at minimum allowable intervals. These 
values are, therefore, slightly conservative. An assessment was 
performed assuming 100% of crop treated (still conservative) as well as 
assuming a more realistic percent of crop treated based on market 
survey data for existing uses or market projections for proposed uses. 
Adjusting

[[Page 6533]]

for percent of crop treated is justified because most of treated 
commodities are combined in central locations and broadly distributed 
to the public, none of the clethodim tolerances or uses are limited to 
specific regions in the United States, and we are primarily concerned 
with chronic dietary exposure which minimizes the variance of single 
serving residues. The results of these more realistic assessments are 
summarized in the Safety Determination section of this document and 
indicate that chronic dietary exposures for existing and proposed uses 
of clethodim are well below the RfD in either case.
    b. Drinking water. Since clethodim is applied outdoors to growing 
agricultural crops, the potential exists for clethodim or its 
metabolites to leach into groundwater. Drinking water, therefore, 
represents a potential route of exposure for clethodim and should be 
considered in an aggregate exposure assessment.
    Based on available studies used in EPA's assessment of 
environmental risk for clethodim (memo from E. Brinson Conerly dated 
June 26, 1990), clethodim itself was classified as mobile in soil, but 
very non-persistent, representing a minimal groundwater concern. 
Metabolites of clethodim were also classified as mobile, but are 
slightly more persistent (half-lives up to 30 days versus up to 3 days 
for parent). Regarding clethodim metabolites, the Agency concluded that 
the ``potential for groundwater contamination may be somewhat higher 
than for clethodim but would still be expected to be relatively low in 
most cases due to their moderately low persistence''.
    There is no established Maximum Concentration Level for residues of 
clethodim in drinking water under the Safe Drinking Water Act.
    Based on this information, Valent believes that clethodim appears 
to represent an insignificant risk for exposure through drinking water.
    2. Non-dietary exposure. Clethodim is currently approved for the 
commercial production of agricultural crops including soybeans, cotton, 
sugar beets, onions, and ornamental plants as well as for use on non-
crop areas. The new uses proposed in this notice of filing are all 
agricultural crops. While there is a potential for clethodim to be used 
in non-crop areas (e.g. around parks and rights-of-way) where the 
public does spend some time, the likelihood of significant exposure is 
very small. First, this grass herbicide cannot be sprayed on lawns 
where the public does spend significant amounts of time, but instead 
must be used where there is no crop or around ornamental plants that 
are tolerant to the chemical. The public does not spend significant 
amounts of time in these areas. And second, clethodim is not persistent 
in the environment so the potential for public exposure is short term. 
Therefore, Valent believes that the potential for non-occupational 
exposure to the general public, other than through the diet or drinking 
water, is insignificant.

D. Cumulative Effects

    There is one other pesticide compound registered in the United 
States, sethoxydim, which is structurally related to clethodim and has 
similar effects on animals. Sethoxydim is approved for use on a variety 
of agricultural crops, in non-crop areas, and around the home. This 
chemical should be considered in an aggregate exposure assessment along 
with clethodim. Dietary exposure is expected to represent the major 
route of exposure for sethoxydim as well as for clethodim.
    The RfD for sethoxydim is 0.09 mg/kg/day based on the 1-year dog 
feeding study NOEL and a 100-fold safety factor. This in on the same 
order of magnitude as clethodim, 0.01 mg/kg/day, which is also based on 
a 1-year dog study and a 100-fold safety factor.
    A discussion of the cumulative effects from clethodim and 
sethoxydim exposures is presented below in the Safety Determination 
section.

E. Safety Determination

    1. U.S. population. Using the dietary exposure assessment 
procedures described above for clethodim, chronic dietary exposures 
resulting from existing and proposed uses of clethodim were compared to 
the RfD of clethodim. In the EPA's conservative analysis (using 
anticipated residues for some crops and 100% of all crops treated), the 
total dietary exposure will occupy 39.4% of the RfD for the U.S. 
population. The highest exposure group is children aged 1 - 6 years, 
where exposure will occupy 84.1% of the RfD. In Valent's conservative 
assessment (using anticipated residues and assuming 100% treated for 
all crops), exposure for the U.S. population would occupy 13.5% of the 
RfD and non-nursing infants (< 1 year) are most highly exposed with 
total exposure occupying 29.1% of the RfD. In Valent's realistic 
analysis (using anticipated residues and estimated percent of crop 
treated for all crops), exposure for the U.S. population would occupy 
only 0.6% of the RfD and non-nursing infants would be at only 1.5% of 
the RfD.
    For sethoxydim, recent EPA dietary assessments have been performed 
in conjunction with tolerance approvals using the very conservative 
assumptions of tolerance values and 100% of crop treated for all crops. 
In a Proposed Rule published in the Federal Register dated February 29, 
1996 (61 FR 7764; FRL-5351-8) the EPA estimated that exposure to all 
existing and proposed tolerances for sethoxydim would occupy 37.7% of 
the sethoxydim RfD for the U.S. population and 74.3% of the RfD for the 
most exposed subpopulation of children aged 1 to 6 years. A more 
realistic assessment utilizing anticipated residues and percent of crop 
treated will certainly reduce exposure by a large amount as with 
clethodim.
    Since clethodim and sethoxydim have similar toxicological effects 
in mammals, the contributions to the individual RfDs should be 
considered in an aggregate exposure assessment. The EPA generally has 
no concern for exposures below 100% of the RfD because the RfD 
represents the level at or below which daily aggregate exposure over a 
lifetime will not pose appreciable risks to human health. Based on the 
very conservative assumptions in the EPA analyses, aggregate exposures 
would exceed 100% if the contributions for these two chemicals were 
summed directly. However, reliable information is not available to 
indicate that directly summing the percent of RfD for these two 
chemicals is the most appropriate thing to do. In addition, as can be 
seen by the Valent assessments using anticipated residue and percent of 
crop treated values, both well-accepted Agency practices, realistic 
exposures are lower by about an order of magnitude. Similar reductions 
would be expected for sethoxydim since actual residues will be lower 
than tolerance levels and percent of crop treated values will likely be 
similar to those for clethodim since they both compete for the same 
post-emergence grass herbicide market. Valent believes that it is 
therefore very likely that aggregate dietary exposure will be well 
below the acceptable level of 100% of the RfD and probably well below 
10%. Unfortunately, Valent does not have access to appropriate values 
for anticipated residues or percent of crop treated for sethoxydim and 
cannot provide an estimate of realistic dietary exposure.
    Regarding drinking water exposures, sethoxydim is similar to 
clethodim representing a minimal risk for leaching into groundwater due 
to its rapid degradation in the environment. There is no established 
Maximum Concentration Level for residues of sethoxydim in drinking 
water under the Safe Drinking Water Act.

[[Page 6534]]

    Regarding non-occupational exposures, sethoxydim is registered for 
use in non-crop areas and around the home and may have some potential 
for exposure to the general public. However, as discussed for 
clethodim, sethoxydim cannot be applied to grass where public contact 
is expected and sethoxydim is not persistent in the environment. Valent 
expects that non-occupational exposures to the public are therefore 
expected to be minimal for sethoxydim.
    In summary, Valent expects that dietary exposure for clethodim and 
sethoxydim are each expected to occupy less than 10% of their RfD's 
when anticipated residue levels and percent of crop treated values are 
considered. Exposures through the drinking water or other non-
occupational routes are expected to be minimal. Collectively, Valent 
believes that the aggregate risks associated with the uses of these two 
chemicals is small and demonstrates a reasonable certainty of no harm 
to the public.
    2. Infants and children. As discussed above, dietary exposure for 
clethodim and sethoxydim is greatest for children ages 1 to 6 years or 
non- nursing infants less than 1 year old. However, using a realistic 
approach to estimating exposures, exposures are expected to be below 
10% of the RfD for each chemical even for infants and children. The 
databases for clethodim and sethoxydim are complete relative to current 
pre- and post-natal toxicity testing requirements including 
developmental toxicity studies in two species and multi-generation 
reproduction studies in rats. Reproduction and developmental effects 
have been found in toxicology studies for clethodim and sethoxydim, but 
the effects were seen at levels that were also maternally toxic. This 
indicates that developing animals are not more sensitive than adults. 
FQPA requires an additional safety factor of up to 10 for chemicals 
which represent special risks to infants or children. Clethodim and 
sethoxydim do not meet the criterion for application of an additional 
safety factor for infants and children. Valent believes that this 
demonstrates a reasonable certainty of no harm to children and infants 
from the proposed uses of clethodim.
    3. International tolerances. Although some have been proposed, 
there are no Canadian, Mexican, or Codex tolerances or maximum residue 
limits established for clethodim on tomatoes, alfalfa, peanuts, or dry 
beans. There are no conflicts between this proposed action and 
international residue limits.

II. Public Record

    EPA invites interested persons to submit comments on this notice of 
filing. Comments must bear a notification indicating the docket control 
number [PF-702]. All written comments filed in response to these 
petitions will be available, in the Public Response and Program 
Resources Branch, at the address given above from 8:30 a.m. to 4 p.m., 
Monday through Friday, except legal holidays.
    A record has been established for this notice under docket control 
number [PF-702] (including comments and data submitted electronically 
as described below). A public version of this record, including 
printed, paper versions of electronic comments, which does not include 
any information claimed as CBI, is available for inspection from 8:30 
a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The 
public record is located in Rm. 1132 of the Public Response and Program 
Resources Branch, Field Operations Division (7506C), Office of 
Pesticide Programs, Environmental Protection Agency, Crystal Mall #2, 
1921 Jefferson Davis Highway, Arlington, VA.
    Electronic comments can be sent directly to EPA at:
    [email protected]

    Electronic comments must be submitted as an ASCII file avoiding the 
use of special characters and any form of encryption.

    The official record for this rulemaking, as well as the public 
version, as described above will be kept in paper form. Accordingly, 
EPA will transfer all comments received electronically into printed, 
paper form as they are received and will place the paper copies in the 
official rulemaking record which will also include all comments 
submitted directly in writing. The official rulemaking record is the 
paper record maintained at the address in ``ADDRESSES'' at the 
beginning of this document.

    Authority: 21 U.S.C. 346a.

List of Subjects

    Environmental Protection, Administrative practice and procedure, 
Agricultural commodities, Pesticides and pests, Reporting and 
recordkeeping requirements.

    Dated: February 3, 1997.

Stephen L. Johnson,

Director, Registration Division, Office of Pesticide Programs.

[FR Doc. 97-3225 Filed 2-11-97; 8:45 am]
BILLING CODE 6560-50-F