[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:
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.
[[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="">50 (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:="">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]
BILLING CODE 6560-50-F
