6530 Federal Register / Vol. 62, No. 29 / Wednesday, February 12, 1997 / Notices

F. International Tolerances

There are no known international

tolerances for residues of propionic acid

in food or animal feed.

G. Tolerance Exemptions for Proposed

Uses

The petitioner proposes new uses

which include application of propionic

acid to sugar beets, potatoes and sweet

potatoes. The petitioner requests

tolerance exemption for residues of

propionic acid in or on sugar beets,

potatoes and sweet potatoes. The

petitioner also requests waivers for all

tests for determining the residues

including the analytical method.

The petitioner proposes tolerance

exemption for propionic acid for its use

on or in:

a. Sugarbeets (stored sugarbeets and

seed sugarbeets, and also dried-pulp

and dried-molasses intended for animal

feed);

b. Potatoes (stored potatoes -

marketable and frozen and stored seed

potatoes, and also stored potatoes for

animal feed); and,

c. Sweet potatoes (stored sweet potato

and stored seed sweet potatoes).

The maximum amount of propionic

acid applied to these RACs during

storage will be 6 lb/ton.

II. Administrative Matters

EPA invites interested persons to

submit comments on this notice of

filing. Comments must bear a

notification indicating the document

control number [PF–694]. All written

comments filed in response to this

petition 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–694] (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 ASCII file avoiding the use

of special characters and any form of

encryption.

The official record for this notice, 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 record which will also include

all comments submitted directly in

writing. The official record is the paper

record maintained at the address in

‘‘ADDRESSEES’’ 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. 97–3227 Filed 2–11–97; 8:45 am]

BILLING CODE 6560–50–F

[PF–702; FRL–5586–3]

Valent U.S.A. Corporation; Pesticide

Tolerance Petition Filing

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Notice of filing.

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: oppdocket@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 EPARM-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.
Federal Register / Vol. 62, No. 29 / Wednesday, February 12, 1997 / Notices 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 threecarbon 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 timelimited 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
6532 Federal Register / Vol. 62, No. 29 / Wednesday, February 12, 1997 / Notices

(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 radiolabel 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 radiolabel 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 timedependent 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
Federal Register / Vol. 62, No. 29 / Wednesday, February 12, 1997 / Notices 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 nonnursing 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 postemergence 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.
6534 Federal Register / Vol. 62, No. 29 / Wednesday, February 12, 1997 / Notices

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 nonoccupational 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 multigeneration 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

FEDERAL COMMUNICATIONS

COMMISSION

Notice of Public Information

Collections Submitted to OMB for

Review and Approval

February 6, 1997.

SUMMARY: The Federal Communications

Commission, as part of its continuing

effort to reduce paperwork burden

invites the general public and other

Federal agencies to take this

opportunity to comment on the

following proposed and/or continuing

information collections, as required by

the Paperwork Reduction Act of 1995,

Public Law 104–13. An agency may not

conduct or sponsor a collection of

information unless it displays a

currently valid control number. No

person shall be subject to any penalty

for failing to comply with a collection

of information subject to the Paperwork

Reduction Act (PRA) that does not

display a valid control number.

Comments are requested concerning (a)

whether the proposed collection of

information is necessary for the proper

performance of the functions of the

Commission, including whether the

information shall have practical utility;

(b) the accuracy of the Commissions

burden estimates; (c)ways to enhance

the quality, utility, and clarity of the

information collected and (d) ways to

minimize the burden of the collection of

information on the respondents,

including the use of automated

collection techniques or other forms of

information technology.

DATES: Written comments should be

submitted on or before March 14, 1997.

If you anticipate that you will be

submitting comments, but find it

difficult to do so within the period of

time allowed by this notice, you should

advise the contact listed below as soon

as possible.

ADDRESSES: Direct all comments to

Dorothy Conway, Federal

Communications Commission, Room

234, 1919 M St., NW., Washington, DC

20554 or via internet to

dconway@fcc.gov and Timothy Fain,

OMB Desk Officer, 10236 NEOB 725

17th Street, NW., Washington, DC 20503

or fain_t@a1.eop.gov.

FOR FURTHER INFORMATION CONTACT: For

additional information or copies of the

information collections contact Dorothy

Conway at 202–418–0217 or via internet

at dconway@fcc.gov.

SUPPLEMENTARY INFORMATION:

OMB Approval No.: 3060–0478.

Title: Informational Tariffs.

Form No. N/A.