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clethodim (Select) Pesticide Tolerance Petition 2/97

[Federal Register: February 12, 1997 (Volume 62, Number 29)] [Notices]
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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: opp-docket@epamail.epa.gov. 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: miller.joanne@epamail.epa.gov.
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. 
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 (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 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. 
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: opp-docket@epamail.epa.gov
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]