44558 Federal Register / Vol. 62, No. 163 / Friday, August 22, 1997 / Rules and Regulations

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 any copies of objections and

hearing requests 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 Virginia

address in ‘‘ADDRESSES’’ at the

beginning of this document.

IX. Regulatory Assessment

Requirements

This final rule establishes a tolerance

under FFDCA section 408(d). The Office

of Management and Budget (OMB) has

exempted these types of actions from

review under Executive Order 12866,

entitled Regulatory Planning and

Review (58 FR 51735, October 4, 1993).

This final rule does not contain any

information collections subject to OMB

approval under the Paperwork

Reduction Act (PRA), 44 U.S.C. 3501 et

seq., or impose any enforceable duty or

contain any unfunded mandate as

described under Title II of the Unfunded

Mandates Reform Act of 1995 (UMRA)

(Pub. L. 104-4). Nor does it require any

prior consultation as specified by

Executive Order 12875, entitled

Enhancing the Intergovernmental

Partnership (58 FR 58093, October 28,

1993), or special considerations as

required by Executive Order 12898,

entitled Federal Actions to Address

Environmental Justice in Minority

Populations and Low-Income

Populations (59 FR 7629, February 16,

1994), or require OMB review in

accordance with Executive Order 13045,

entitled Protection of Children from

Environmental Health Risks and Safety

Risks (62 FR 19885, April 23, 1997).

In addition, since these tolerances and

exemptions that are established under

FFDCA section 408 (l)(6), such as the

tolerance in this final rule, do not

require the issuance of a proposed rule,

the requirements of the Regulatory

Flexibility Act (RFA) (5 U.S.C. 601 et

seq.) do not apply. Nevertheless, the

Agency has previously assessed whether

establishing tolerances, exemptions

from tolerances, raising tolerance levels

or expanding exemptions might

adversely impact small entities and

concluded, as a generic matter, that

there is no adverse economic impact.

The factual basis for the Agency’s

generic certification for tolerance

actions published on May 4, 1981 (46

FR 24950), and was provided to the

Chief Counsel for Advocacy of the Small

Business Administration.

X. Submission to Congress and the

General Accounting Office

Under 5 U.S.C. 801(a)(1)(A), as added

by the Small Business Regulatory

Enforcement Fairness Act of 1996, the

Agency has submitted a report

containing this rule and other required

information to the U.S. Senate, the U.S.

House of Representatives, and the

Comptroller General of the General

Accounting Office prior to publication

of this rule in today’s Federal Register.

This is not a ‘‘major rule’’ as defined by

5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

Environmental protection,

Administrative practice and procedure,

Agricultural commodities, Pesticides

and pests, Reporting and recordkeeping

requirements.

Dated: August 12, 1997.

James Jones,

Acting Director, Registration Division, Office

of Pesticide Programs.

Therefore, 40 CFR chapter I is

amended as follows:

PART 180—[AMENDED]

1. The authority citation for part 180

continues to read as follows:

Authority: 21 U.S.C. 346a and 371.

2. Section 180.462 is amended to read

as follows:

a. By designating the existing text as

paragraph (a) and adding a heading.

b. By adding paragraph (b).

c. By adding the headings and

reserving paragraphs (c) and (d).

Section 180.462, as amended, reads as

follows:

§ 180.462 Pyridate; tolerances for

residues.

(a) General . * * *

(b) Section 18 emergency exemptions.

A time-limited tolerance is established

for the residue of the herbicide pyridate

in connection with use of the pesticide

under section 18 emergency exemptions

granted by EPA. This tolerance will

expire and is revoked on the date

specified in the following table:

Commodity Parts per

million

Expiration/

revocation

date

Chickpeas ......... 0.1 12/31/98

(c) Tolerances with regional

registrations. [Reserved]

(d) Indirect or inadvertent residues.

[Reserved]

[FR Doc. 97–22373 Filed 8–21–97; 8:45 am]

BILLING CODE 6560–50–F

ENVIRONMENTAL PROTECTION

AGENCY

40 CFR Part 180

[OPP–300533; FRL–5738–6]

RIN 2070–AB78

Sethoxydim; Pesticide Tolerances for

Emergency Exemptions

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Final rule.

SUMMARY: This regulation establishes a

time-limited tolerance for residues of

sethoxydim and its metabolites

containing the 2-cyclohexen-1-one

moiety in or on horseradish. This action

is in response to EPA’s granting of an

emergency exemption under section 18

of the Federal Insecticide, Fungicide,

and Rodenticide Act authorizing use of

the pesticide on horseradish in Illinois.

This regulation establishes a maximum

permissible level for residues of

sethoxydim in this food commodity

pursuant to section 408(l)(6) of the

Federal Food, Drug, and Cosmetic Act,

as amended by the Food Quality

Protection Act of 1996. The tolerance

will expire and is revoked on September

30, 1998.

DATES: This regulation is effective

August 22, 1997. Objections and

requests for hearings must be received

by EPA on or before October 21, 1997.

ADDRESSES: Written objections and

hearing requests, identified by the

docket control number, [OPP–300533],

must be submitted to: Hearing Clerk

(1900), Environmental Protection

Agency, Rm. M3708, 401 M St., SW.,

Washington, DC 20460. Fees

accompanying objections and hearing

requests shall be labeled ‘‘Tolerance

Petition Fees’’ and forwarded to: EPA

Headquarters Accounting Operations

Branch, OPP (Tolerance Fees), P.O. Box

360277M, Pittsburgh, PA 15251. A copy

of any objections and hearing requests

filed with the Hearing Clerk identified

by the docket control number, [OPP–

300533], must also be submitted to:

Public Information and Records

Integrity Branch, Information Resources

and Services Division (7506C), Office of

Pesticide Programs, Environmental

Protection Agency, 401 M St., SW.,

Washington, DC 20460. In person, bring

a copy of objections and hearing
Federal Register / Vol. 62, No. 163 / Friday, August 22, 1997 / Rules and Regulations 44559

requests to Rm. 1132, CM #2, 1921

Jefferson Davis Hwy., Arlington, VA.

A copy of objections and hearing

requests filed with the Hearing Clerk

may also be submitted electronically by

sending electronic mail (e-mail) to: oppdocket@epamail.epa.gov. Copies of

objections and hearing requests must be

submitted as an ASCII file avoiding the

use of special characters and any form

of encryption. Copies of objections and

hearing requests will also be accepted

on disks in WordPerfect 5.1 file format

or ASCII file format. All copies of

objections and hearing requests in

electronic form must be identified by

the docket control number [OPP–

300533]. No Confidential Business

Information (CBI) should be submitted

through e-mail. Electronic copies of

objections and hearing requests on this

rule may be filed online at many Federal

Depository Libraries.

FOR FURTHER INFORMATION CONTACT: By

mail: Virginia Dietrich, Registration

Division 7505C, Office of Pesticide

Programs, Environmental Protection

Agency, 401 M St., SW., Washington,

DC 20460. Office location, telephone

number, and e-mail address: Crystal

Mall #2, 1921 Jefferson Davis Hwy.,

Arlington, VA, (703) 308-9359, e-mail:

dietrich.virginia@epamail.epa.gov.

SUPPLEMENTARY INFORMATION: EPA, on

its own initiative, pursuant to section

408(e) and (l)(6) of the Federal Food,

Drug, and Cosmetic Act (FFDCA), 21

U.S.C. 346a(e) and (l)(6), is establishing

a tolerance for residues of the herbicide

sethoxydim, in or on horseradish at 4

part per million (ppm). This tolerance

will expire and is revoked on September

30, 1998. EPA will publish a document

in the Federal Register to remove the

revoked tolerance from the Code of

Federal Regulations.

I. Background and Statutory Authority

The Food Quality Protection Act of

1996 (FQPA) (Pub. L. 104–170) was

signed into law August 3, 1996. FQPA

amends both the Federal Food, Drug,

and Cosmetic Act (FFDCA), 21 U.S.C.

301 et seq., and the Federal Insecticide,

Fungicide, and Rodenticide Act

(FIFRA), 7 U.S.C. 136 et seq . The FQPA

amendments went into effect

immediately. Among other things,

FQPA amends FFDCA to bring all EPA

pesticide tolerance-setting activities

under a new section 408 with a new

safety standard and new procedures.

These activities are described below and

discussed in greater detail in the final

rule establishing the time-limited

tolerance associated with the emergency

exemption for use of propiconazole on

sorghum (61 FR 58135, November 13,

1996)(FRL-5572-9).

New section 408(b)(2)(A)(i) of the

FFDCA allows EPA to establish a

tolerance (the legal limit for a pesticide

chemical residue in or on a food) only

if EPA determines that the tolerance is

‘‘safe.’’ Section 408(b)(2)(A)(ii) defines

‘‘safe’’ to mean that ‘‘there is a

reasonable certainty that no harm will

result from aggregate exposure to the

pesticide chemical residue, including

all anticipated dietary exposures and all

other exposures for which there is

reliable information.’’ This includes

exposure through drinking water and in

residential settings, but does not include

occupational exposure. Section

408(b)(2)(C) requires EPA to give special

consideration to exposure of infants and

children to the pesticide chemical

residue in establishing a tolerance and

to ‘‘ensure that there is a reasonable

certainty that no harm will result to

infants and children from aggregate

exposure to the pesticide chemical

residue. . . .’’

Section 18 of FIFRA authorizes EPA

to exempt any Federal or State agency

from any provision of FIFRA, if EPA

determines that ‘‘emergency conditions

exist which require such exemption.’’

This provision was not amended by

FQPA. EPA has established regulations

governing such emergency exemptions

in 40 CFR part 166.

Section 408(l)(6) of the FFDCA

requires EPA to establish a time-limited

tolerance or exemption from the

requirement for a tolerance for pesticide

chemical residues in food that will

result from the use of a pesticide under

an emergency exemption granted by

EPA under section 18 of FIFRA. Such

tolerances can be established without

providing notice or period for public

comment.

Because decisions on section 18-

related tolerances must proceed before

EPA reaches closure on several policy

issues relating to interpretation and

implementation of the FQPA, EPA does

not intend for its actions on such

tolerance to set binding precedents for

the application of section 408 and the

new safety standard to other tolerances

and exemptions.

II. Emergency Exemption for

Sethoxydim on Horseradish and

FFDCA Tolerances

Unprecedented flooding events in the

horseradish production areas in Illinois

in the last few years have transported

seeds and vegetative propagules to

previously uninfested fields. Currently

registered herbicides, as well as cultural

practices (mechanical and hand

weeding), do not provide adequate

control. Of particular concern was

infestation by Johnsongrass.

Johnsongrass causes losses by

competing with the crop thereby

reducing yields. Losses were also

realized at the packing houses because

of the similarity of horseradish roots to

Johnsongrass rhizomes. After having

reviewed the submission, EPA concurs

that emergency conditions exist for this

state. EPA has authorized under FIFRA

section 18 the use of sethoxydim on

horseradish for control of grass weeds in

Illinois.

As part of its assessment of this

emergency exemption, EPA assessed the

potential risks presented by residues of

sethoxydim in or on horseradish. In

doing so, EPA considered the new safety

standard in FFDCA section 408(b)(2),

and EPA decided that the necessary

tolerance under FFDCA section 408(l)(6)

would be consistent with the new safety

standard and with FIFRA section 18.

Consistent with the need to move

quickly on the emergency exemption in

order to address an urgent non-routine

situation and to ensure that the resulting

food is safe and lawful, EPA is issuing

this tolerance without notice and

opportunity for public comment under

section 408(e), as provided in section

408(l)(6). Although this tolerance will

expire and is revoked on September 30,

1998, under FFDCA section 408(l)(5),

residues of the pesticide not in excess

of the amounts specified in the

tolerance remaining in or on

horseradish after that date will not be

unlawful, provided the pesticide is

applied in a manner that was lawful

under FIFRA. EPA will take action to

revoke this tolerance earlier if any

experience with, scientific data on, or

other relevant information on this

pesticide indicate that the residues are

not safe.

Because this tolerance is being

approved under emergency conditions

EPA has not made any decisions about

whether sethoxydim meets EPA’s

registration requirements for use on

horseradish or whether a permanent

tolerance for this use would be

appropriate. Under these circumstances,

EPA does not believe that this tolerance

serves as a basis for registration of

sethoxydim by a State for special local

needs under FIFRA section 24(c). Nor

does this tolerance serve as the basis for

any State other than Illinois to use this

pesticide on this crop under section 18

of FIFRA without following all

provisions of section 18 as identified in

40 CFR part 166. For additional

information regarding the emergency

exemption for sethoxydim, contact the

Agency’s Registration Division at the

address provided above.
44560 Federal Register / Vol. 62, No. 163 / Friday, August 22, 1997 / Rules and Regulations

III. Risk Assessment and Statutory

Findings

EPA performs a number of analyses to

determine the risks from aggregate

exposure to pesticide residues. First,

EPA determines the toxicity of

pesticides based primarily on

toxicological studies using laboratory

animals. These studies address many

adverse health effects, including (but

not limited to) reproductive effects,

developmental toxicity, toxicity to the

nervous system, and carcinogenicity.

Second, EPA examines exposure to the

pesticide through the diet (e.g., food and

drinking water) and through exposures

that occur as a result of pesticide use in

residential settings.

A. Toxicity

1. Threshold and non-threshold

effects. For many animal studies, a dose

response relationship can be

determined, which provides a dose that

causes adverse effects (threshold effects)

and doses causing no observed effects

(the ‘‘no-observed effect level’’ or

‘‘NOEL’’).

Once a study has been evaluated and

the observed effects have been

determined to be threshold effects, EPA

generally divides the NOEL from the

study with the lowest NOEL by an

uncertainty factor (usually 100 or more)

to determine the Reference Dose (RfD).

The RfD is a level at or below which

daily aggregate exposure over a lifetime

will not pose appreciable risks to

human health. An uncertainty factor

(sometimes called a ‘‘safety factor’’) of

100 is commonly used since it is

assumed that people may be up to 10

times more sensitive to pesticides than

the test animals, and that one person or

subgroup of the population (such as

infants and children) could be up to 10

times more sensitive to a pesticide than

another. In addition, EPA assesses the

potential risks to infants and children

based on the weight of the evidence of

the toxicology studies and determines

whether an additional uncertainty factor

is warranted. Thus, an aggregate daily

exposure to a pesticide residue at or

below the RfD (expressed as 100% or

less of the RfD) is generally considered

acceptable by EPA. EPA generally uses

the RfD to evaluate the chronic risks

posed by pesticide exposure. For shorter

term risks, EPA calculates a margin of

exposure (MOE) by dividing the

estimated human exposure into the

NOEL from the appropriate animal

study. Commonly, EPA finds MOEs

lower than 100 to be unacceptable. This

100-fold MOE is based on the same

rationale as the 100-fold uncertainty

factor.

Lifetime feeding studies in two

species of laboratory animals are

conducted to screen pesticides for

cancer effects. When evidence of

increased cancer is noted in these

studies, the Agency conducts a weight

of the evidence review of all relevant

toxicological data including short-term

and mutagenicity studies and structure

activity relationship. Once a pesticide

has been classified as a potential human

carcinogen, different types of risk

assessments (e.g., linear low dose

extrapolations or MOE calculation based

on the appropriate NOEL) will be

carried out based on the nature of the

carcinogenic response and the Agency’s

knowledge of its mode of action.

2. Differences in toxic effect due to

exposure duration. The toxicological

effects of a pesticide can vary with

different exposure durations. EPA

considers the entire toxicity data base,

and based on the effects seen for

different durations and routes of

exposure, determines which risk

assessments should be done to assure

that the public is adequately protected

from any pesticide exposure scenario.

Both short and long durations of

exposure are always considered.

Typically, risk assessments include

‘‘acute’’, ‘‘short-term’’, ‘‘intermediate

term’’, and ‘‘chronic’’ risks. These

assessments are defined by the Agency

as follows.

Acute risk, by the Agency’s definition,

results from 1-day consumption of food

and water, and reflects toxicity which

could be expressed following a single

oral exposure to the pesticide residues.

High end exposure to food and water

residues are typically assumed.

Short-term risk results from exposure

to the pesticide for a period of 1-7 days,

and therefore overlaps with the acute

risk assessment. Historically, this risk

assessment was intended to address

primarily dermal and inhalation

exposure which could result, for

example, from residential pesticide

applications. However, since enaction of

FQPA, this assessment has been

expanded to include both dietary and

non-dietary sources of exposure, and

will typically consider exposure from

food, water, and residential uses when

reliable data are available. In this

assessment, risks from average food and

water exposure, and high-end

residential exposure, are aggregated.

High-end exposures from all 3 sources

are not typically added because of the

very low probability of this occurring in

most cases, and because the other

conservative assumptions built into the

assessment assure adequate protection

of public health. However, for cases in

which high-end exposure can

reasonably be expected from multiple

sources (e.g. frequent and widespread

homeowner use in a specific

geographical area), multiple high-end

risks will be aggregated and presented

as part of the comprehensive risk

assessment/characterization. Since the

toxicological endpoint considered in

this assessment reflects exposure over a

period of at least 7 days, an additional

degree of conservatism is built into the

assessment; i.e., the risk assessment

nominally covers 1-7 days exposure,

and the toxicological endpoint/NOEL is

selected to be adequate for at least 7

days of exposure. (Toxicity results at

lower levels when the dosing duration

is increased.)

Intermediate-term risk results from

exposure for 7 days to several months.

This assessment is handled in a manner

similar to the short-term risk

assessment.

Chronic risk assessment describes risk

which could result from several months

to a lifetime of exposure. For this

assessment, risks are aggregated

considering average exposure from all

sources for representative population

subgroups including infants and

children.

B. Aggregate Exposure

In examining aggregate exposure,

FFDCA section 408 requires that EPA

take into account available and reliable

information concerning exposure from

the pesticide residue in the food in

question, residues in other foods for

which there are tolerances, residues in

groundwater or surface water that is

consumed as drinking water, and other

non-occupational exposures through

pesticide use in gardens, lawns, or

buildings (residential and other indoor

uses). Dietary exposure to residues of a

pesticide in a food commodity are

estimated by multiplying the average

daily consumption of the food forms of

that commodity by the tolerance level or

the anticipated pesticide residue level.

The Theoretical Maximum Residue

Contribution (TMRC) is an estimate of

the level of residues consumed daily if

each food item contained pesticide

residues equal to the tolerance. In

evaluating food exposures, EPA takes

into account varying consumption

patterns of major identifiable subgroups

of consumers, including infants and

children.The TMRC is a ‘‘worst case’’

estimate since it is based on the

assumptions that food contains

pesticide residues at the tolerance level

and that 100% of the crop is treated by

pesticides that have established

tolerances. If the TMRC exceeds the RfD

or poses a lifetime cancer risk that is

greater than approximately one in a
Federal Register / Vol. 62, No. 163 / Friday, August 22, 1997 / Rules and Regulations 44561

million, EPA attempts to derive a more

accurate exposure estimate for the

pesticide by evaluating additional types

of information (anticipated residue data

and/or percent of crop treated data)

which show, generally, that pesticide

residues in most foods when they are

eaten are well below established

tolerances.

Percent of crop treated estimates are

derived from federal and private market

survey data. Typically, a range of

estimates are supplied and the upper

end of this range is assumed for the

exposure assessment. By using this

upper end estimate of percent of crop

treated, the Agency is reasonably certain

that exposure is not understated for any

significant subpopulation group.

Further, regional consumption

information is taken into account

through EPA’s computer-based model

for evaluating the exposure of

significant subpopulations including

several regional groups, to pesticide

residues. For this pesticide, the most

highly exposed population subgroup

(children from one to six years old) was

not regionally based.

IV. Aggregate Risk Assessment and

Determination of Safety

Consistent with section 408(b)(2)(D),

EPA has reviewed the available

scientific data and other relevant

information in support of this action,

EPA has sufficient data to assess the

hazards of sethoxydim and to make a

determination on aggregate exposure,

consistent with section 408(b)(2), for a

time-limited tolerance for residues of

sethoxydim and its 2-cyclohexen-1-one

moiety on horseradish at 4 ppm. EPA’s

assessment of the dietary exposures and

risks associated with establishing the

tolerance follows.

A. Toxicological Profile

EPA has evaluated the available

toxicity data and considered its validity,

completeness, and reliability as well as

the relationship of the results of the

studies to human risk. EPA has also

considered available information

concerning the variability of the

sensitivities of major identifiable

subgroups of consumers, including

infants and children. The nature of the

toxic effects caused by sethoxydim are

discussed below.

1. Acute toxicity. 180 mg/kg/day. For

acute dietary risk assessment, the Office

of Pesticide Programs selected the

developmental NOEL of 180 mg/kg/day

from the developmental study in rats. At

the developmental lowest observed

effect level (LOEL) of 650 mg/kg/day,

there were decreased fetal weights,

filamentous tail, lack of tail, and

delayed ossification. Acute dietary risk

will be evaluated for the population

subgroup of concern, females 13+ years.

2. Short - and intermediate - term

toxicity. For short- and intermediateterm Margin of Exposure (MOE)

calculations, the Office of pesticide

Programs concluded that this risk

assessment is not required, based on the

lack of any observable effects in a 21-

day dermal toxicity study in rabbits at

the limit dose (1000 mg/kg/day) and the

observation of no adverse effects in a

developmental toxicity study in rabbits

at 400 mg/kg/day, the highest dose

tested (HDT).

3. Chronic toxicity. EPA has

established the RfD for sethoxydim at

0.09 milligrams/kilogram/day (mg/kg/

day). This RfD is based on a 1-year

feeding study in dogs (MRID#

00152669) with a NOEL of 8.86 mg/kg/

day and an uncertainty factor of 100

based on equivocal anemia in male dogs

at the lowest effect level (LEL) of 17.5

mg/kg/day.

4. Carcinogenicity. Sethoxydim has

not been classified with concern to

carcinogenicity by the Office of

Pesticide Programs. However, no

positive tumor findings have been

reported at this time.

B. Exposures and Risks

1. From food and feed uses.

Tolerances have been established (40

CFR 180.412) for combined residues of

sethoxydim and its metabolites

containing the 2-cyclohexen-1-one

moiety (calculated as the herbicide) in

or on a variety of raw agricultural

commodities (RACs) at levels ranging

from 0.2 ppm to 50 ppm. Among them

are tolerances on several RACs of the

root and tuber vegetables crop group, of

which horseradish is a member:

artichoke (3 ppm), carrots (1 ppm),

potatoes (4 ppm), sweet potatoes (4

ppm), and sugar beet roots (1 ppm).

Various food (40 CFR 185.2800) and

feed (40 CFR 186.2800) additive

tolerances are also established, at levels

up to 75 ppm (peanut soapstock). Risk

assessments were conducted by EPA to

assess dietary exposures and risks from

sethoxydim as follows:

i. Acute exposure and risk. The acute

dietary (food only) risk assessment used

tolerance level residues for all crops

with sethoxydim tolerances and

assumed 100% crop-treated. A Margin

of Exposure (MOE) of 960 was

calculated for females aged 13+ years,

the population subgroup of concern.

That acute dietary (food only) MOE

should be viewed as a conservative risk

estimate; refinement using percent croptreated and anticipated residue levels or

Monte Carlo analysis would result in a

lower dietary exposure estimate. Acute

dietary risk assessments are performed

for a food-use pesticide if a toxicological

study has indicated the possibility of an

effect of concern occurring as a result of

a one day or single exposure.

ii. Chronic exposure and risk. In

conducting this chronic dietary risk

assessment, the Office of Pesticide

Programs has made very conservative

assumptions which result in a

conservative over-estimate of human

dietary exposure; 100% of horseradish

and all other commodities having

tolerances for the regulable residue of

sethoxydim will contain residues of

same, and at the level of the tolerance.

Refinement using anticipated residue

values and percent crop-treated data

would result in a lower chronic dietary

exposure estimate.

The existing sethoxydim regulable

residue tolerances (published, pending,

and this Section 18 proposed tolerance)

result in a Theoretical Maximum

Residue Contribution (TMRC) that is

equivalent to the following percentages

of the RfD:

Population Subgroup TMRCfood (mg/kg/day) %RfD

U.S. population (48 states) .................................................................................. 0.033266 37%

Nursing infants ..................................................................................................... 0.020447 23%

Non-nursing infants (<1 year old) ........................................................................ 0.057129 63%

Children (1-6 years old) ....................................................................................... 0.067039 74%

Children (7-12 years old) ..................................................................................... 0.049618 55%

Southern Region .................................................................................................. 0.033782 38%

Western Region ................................................................................................... 0.034829 39%

Hispanics .............................................................................................................. 0.039524 44%

Males (13-19 years old) ....................................................................................... 0.033837 38%
44562 Federal Register / Vol. 62, No. 163 / Friday, August 22, 1997 / Rules and Regulations

The subgroups listed above are: (1)

the U.S. population (48 states); (2) those

for infants and children; and, (3) the

other subgroups for which the

percentage of the RfD occupied is

greater than that occupied by the

subgroup U.S. population (48 states).

2. From drinking water. Based on

information in OPP files, sethoxydim is

a non-persistent, but highly mobile

compound in soil and water

environments. There are no Maximum

Contaminant Levels or Health

Advisories established for sethoxydim

residues in drinking water.

Limited monitoring data of ground

water and surface water are available for

sethoxydim. Exposure estimates using

these data are listed below.

Adult Exposure: Groundwater

Sethoxydim Exposure (highest

concentration detected in public supply

wells) = (1 μg/L) * (10-3 mg/μg) ÷ (70 kg

body weight) * (2 L/day) = 2.85 x 10-5

mg/kg/day.

Sethoxydim Exposure (highest

concentration detected in ground water)

= (42 μg/L) * (10-3 mg/μg) ÷ (70 kg body

weight) * (2 L/day) = 1.2 x 10-3 mg/kg/

day

Children’s Exposure: Groundwater

Sethoxydim Exposure (highest

concentration detected in public supply

wells) = (1 μg/L) * (10-3 mg/μg) ÷ (10 kg

body weight) * (1 L/day) = 1 x 10-4 mg/

kg/day.

Sethoxydim Exposure (highest

concentration detected in ground water)

= (42 μg/L) * (10-3 mg/μg) ÷ (10 kg body

weight) * (1 L/day) = 4.2 x 10-3 mg/kg/

day

Estimates of Exposure: Surface Water.

The highest concentration of

sethoxydim residues detected in a

surface water sample was 0.87 μg/L. The

same calculations as above for ground

water were used to estimate the

exposure of adults (2.49 x 10-5 mg/kg/

day) and children (0.9 x 10-4 mg/kg/day)

to sethoxydim residues in surface water.

i. Acute exposure and risk. The Office

of Pesticide Programs calculates a

margin of exposure (MOE) to estimate

the acute risk for drinking water, as

follows:

Acute MOE = Acute NOEL (mg/kg/day)

÷ Exposure (mg/kg/day)

The acute dietary endpoint is based

on the developmental NOEL of 180 mg/

kg/day from the developmental study in

rats. Using the exposure estimates

calculated above, the acute MOEs for

adults and children are calculated to be

> 40,000.

Using the surface water exposure

estimates calculated above, the acute

MOEs for adults and children are

calculated to be > 1.8 million.

ii. Chronic exposure and risk. Because

the Agency lacks sufficient waterrelated exposure data to complete a

comprehensive drinking water risk

assessment for many pesticides, EPA

has commenced and nearly completed a

process to identify a reasonable yet

conservative bounding figure for the

potential contribution of water-related

exposure to the aggregate risk posed by

a pesticide. In developing the bounding

figure, EPA estimated residue levels in

water for a number of specific pesticides

using various data sources. The Agency

then applied the estimated residue

levels, in conjunction with appropriate

toxicological endpoints (RfD’s or acute

dietary NOEL’s) and assumptions about

body weight and consumption, to

calculate, for each pesticide, the

increment of aggregate risk contributed

by consumption of contaminated water.

While EPA has not yet pinpointed the

appropriate bounding figure for

exposure from contaminated water, the

ranges the Agency is continuing to

examine are all below the level that

would cause sethoxydim to exceed the

RfD if the tolerance being considered in

this document were granted. The

Agency has therefore concluded that the

potential exposures associated with

sethoxydim in water, even at the higher

levels the Agency is considering as a

conservative upper bound, would not

prevent the Agency from determining

that there is a reasonable certainty of no

harm if the tolerance is granted.

Using the surface water exposure

estimates calculated above, the chronic

risks are calculated to be < 1% of the

RfD for both adults and children.

3. From non-dietary exposure.

Sethoxydim is currently registered for

use on the following residential nonfood sites: flowering plants, recreational

areas, and buildings/structures (nonagricultural - outdoor). These residential

uses comprise a short- and intermediateterm exposure scenario, but do not

comprise a chronic exposure scenario.

Since the TESC did not identify a shortterm, intermediate-term, or chronic

toxicity non-dietary endpoint, a shortand intermediate-term aggregate risk

assessment is not required for this

Section 18 action.

Short- and intermediate-term

exposure and risk. The Office of

Pesticide Programs determined that a

risk assessment for short- and

intermediate term exposure is not

appropriate since no adverse effects

were noted in toxicity studies

conducted for this duration of exposure

4. Cumulative exposure to substances

with common mechanism of toxicity.

Section 408(b)(2)(D)(v) requires that,

when considering whether to establish,

modify, or revoke a tolerance, the

Agency consider ‘‘available

information’’ concerning the cumulative

effects of a particular pesticide’s

residues and ‘‘other substances that

have a common mechanism of toxicity.’’

The Agency believes that ‘‘available

information’’ in this context might

include not only toxicity, chemistry,

and exposure data, but also scientific

policies and methodologies for

understanding common mechanisms of

toxicity and conducting cumulative risk

assessments. For most pesticides,

although the Agency has some

information in its files that may turn out

to be helpful in eventually determining

whether a pesticide shares a common

mechanism of toxicity with any other

substances, EPA does not at this time

have the methodologies to resolve the

complex scientific issues concerning

common mechanism of toxicity in a

meaningful way. EPA has begun a pilot

process to study this issue further

through the examination of particular

classes of pesticides. The Agency hopes

that the results of this pilot process will

increase the Agency’s scientific

understanding of this question such that

EPA will be able to develop and apply

scientific principles for better

determining which chemicals have a

common mechanism of toxicity and

evaluating the cumulative effects of

such chemicals. The Agency anticipates,

however, that even as its understanding

of the science of common mechanisms

increases, decisions on specific classes

of chemicals will be heavily dependent

on chemical specific data, much of

which may not be presently available.

Although at present the Agency does

not know how to apply the information

in its files concerning common

mechanism issues to most risk

assessments, there are pesticides as to

which the common mechanism issues

can be resolved. These pesticides

include pesticides that are

toxicologically dissimilar to existing

chemical substances (in which case the

Agency can conclude that it is unlikely

that a pesticide shares a common

mechanism of activity with other

substances) and pesticides that produce

a common toxic metabolite (in which

case common mechanism of activity

will be assumed).

EPA does not have, at this time,

available data to determine whether

sethoxydim has a common mechanism

of toxicity with other substances or how

to include this pesticide in a cumulative

risk assessment. Unlike other pesticides

for which EPA has followed a

cumulative risk approach based on a

common mechanism of toxicity,

sethoxydim does not appear to produce
Federal Register / Vol. 62, No. 163 / Friday, August 22, 1997 / Rules and Regulations 44563

a toxic metabolite produced by other

substances. For the purposes of this

tolerance action, therefore, EPA has not

assumed that sethoxydim has a common

mechanism of toxicity with other

substances.

C. Aggregate Risks and Determination of

Safety for U.S. Population

1. Acute risk. The aggregate (food +

water) MOE value is and is 935, based

on an MOEfood of 960 and a conservative

MOEwater of 40,000. This aggregate MOE

value does not exceed the Agency’s

level of concern for acute dietary

exposure.

2. Chronic risk. Using the

conservative TMRC exposure

assumptions described above, and

taking into account the completeness

and reliability of the toxicity data, EPA

has concluded that chronic aggregate

dietary exposure (food + water) to

sethoxydim will utilize 38% (37% from

food + ≤ 1% from water) of the RfD for

the U.S. population. EPA generally has

no concern for exposures below 100%

of the RfD because the RfD represents

the level at or below which daily

aggregate dietary exposure over a

lifetime will not pose appreciable risks

to human health. Residential (outdoor)

usage of sethoxydim does not comprise

a chronic exposure scenario. EPA

concludes that there is a reasonable

certainty that no harm will result from

chronic aggregate exposure to

sethoxydim residues.

3. Short- and intermediate-term risk.

Short- and intermediate-term aggregate

exposure takes into account chronic

dietary food and water (considered to be

a background exposure level) plus shortand intermediate-term exposure

scenarios from indoor and outdoor

residential uses. Since the Office of

Pesticide Programs did not identify a

short-term, intermediate-term, or

chronic toxicity non-dietary endpoint, a

short- and intermediate-term aggregate

risk assessment was not conducted for

this duration of exposure.

D. Aggregate Cancer Risk for U.S.

Population

Sethoxydim has not been classified by

the Agency’s Cancer Peer Review

Committee. However, no positive tumor

findings have been reported at this time

in the evaluation of the cancer study in

mice or the preliminary evaluation of

the rat study.

E. Aggregate Risks and Determination of

Safety for Infants and Children

1. Safety factor for infants and

children— i. In general. In assessing the

potential for additional sensitivity of

infants and children to residues of

sethoxydim, EPA considered data from

developmental toxicity studies in the rat

and rabbit and a two-generation

reproduction study in the rat. The

developmental toxicity studies are

designed to evaluate adverse effects on

the developing organism resulting from

maternal pesticide exposure during

gestation. Reproduction studies provide

information relating to effects from

exposure to the pesticide on the

reproductive capability of mating

animals and data on systemic toxicity.

FFDCA section 408 provides that EPA

shall apply an additional tenfold margin

of safety for infants and children in the

case of threshold effects to account for

pre-and post-natal toxicity and the

completeness of the database unless

EPA determines that a different margin

of safety will be safe for infants and

children. Margins of safety are

incorporated into EPA risk assessments

either directly through use of a MOE

analysis or through using uncertainty

(safety) factors in calculating a dose

level that poses no appreciable risk to

humans. EPA believes that reliable data

support using the standard 100-fold

safety factor (usually 100 for combined

inter- and intra-species variability)) and

not the additional tenfold safety factor

when EPA has a complete data base

under existing guidelines and when the

severity of the effect in infants or

children or the potency or unusual toxic

properties of a compound do not raise

concerns regarding the adequacy of the

standard safety factor.

ii. Developmental toxicity studies— a.

Rats. In the developmental toxicity

study in rats, the maternal (systemic)

NOEL was 180 mg/kg/day, based on

irregular gait, decreased activity,

excessive salivation and anogenital

staining at the LOEL of 650 mg/kg/day.

The developmental (pup) NOEL was

180 mg/kg/day, based on decreased fetal

weights, filamentous tail, lack of tail,

and delayed ossification at the LOEL of

650 mg/kg/day.

b. Rabbits. In the developmental

toxicity study in rabbits, the maternal

(systemic) NOEL was 320 mg/kg/day,

based on a 37% reduction in body

weight gain without significant

differences in group mean body weights

and food consumption at the LOEL of

400 mg/kg/ day. The developmental

(pup) NOEL was ι 400 mg/kg/day

(HDT).

iii. Reproductive toxicity study—

Rats. In the 2-generation reproductive

toxicity study in rats, the maternal

(systemic) and reproductive (pup) NOEL

was ≈ 150 mg/kg/day (HDT). There were

no indications of toxicity, dose-related

effects on fertility or difficult deliveries

in either parental generation.

iv. Pre- and post-natal sensitivity. The

toxicological data base for evaluating

pre- and post-natal toxicity for

sethoxydim is complete with respect to

current data requirements.

The available data indicate that no

developmental toxicity was observed in

the rabbit study at the highest dose

tested (400 mg/kg/day). Maternal

toxicity was observed in the rabbit at the

highest dose tested, and consisted of

significant reductions in body weight

gain and food consumption.

In the developmental study in rats,

developmental toxicity was observed in

the presence of significant maternal

toxicity at a high dose level (650 mg/kg/

day).

There was no parental or reproductive

toxicity observed in a multi-generation

reproductive toxicity study in rats at

doses up to 150 mg/kg/day (HDT).

These data, taken together, suggest

minimal concern for developmental or

reproductive toxicity and do not

indicate any extra pre- or post-natal

sensitivity. Thus, these data support use

of the standard uncertainty factor of

100. An additional safety factor is not

needed to protect infants and children.

v. Conclusion. These data, taken

together, suggest minimal concern for

developmental or reproductive toxicity

and do not indicate any extra pre- or

post-natal sensitivity. Thus, these data

support use of the standard uncertainty

factor of 100. An additional safety factor

is not needed to protect infants and

children.

2. Acute risk. As calculated above, the

acute dietary (food + water) MOE for

females 13+ years (accounts for both

maternal and fetal exposure) is 935,

based on an MOEfood of 960 and a

conservative MOEwater of 40,000. This

dietary MOE does not exceed the

Agency’s level of concern. Further, this

MOE should be viewed as a

conservative risk estimate; data

refinement and the use of Monte Carlo

analysis would result in a lower acute

aggregate exposure estimate. HED

concludes that there is a reasonable

certainty that no harm will result to

infants and children from acute

aggregate exposure to sethoxydim

regulable residue.

3. Chronic risk. Using the

conservative exposure assumptions

described above, EPA has calculated

that the percentage of the RfD that will

be utilized by dietary (food only)

exposure to the sethoxydim regulable

residue ranges from 23% for nursing

infants < 1 year old, up to 74% for

children 1-6 years old. As calculated

above, the percentage of the RfD that

will be utilized by dietary (water)

exposure ranges from < 1 to 5% from
44564 Federal Register / Vol. 62, No. 163 / Friday, August 22, 1997 / Rules and Regulations

ground water and <1% from surface

water. Thus, the chronic aggregate (food

+ water) risk ranges from ≈ 24-29% for

nursing infants < 1 year old, to ≈ 75-

80% for children 1-6 years old. It has

been determined by HED that

residential uses do not comprise a

chronic exposure scenario, and thus

will not contribute to chronic aggregate

risk. EPA generally has no concern for

exposures below 100% of the RfD

because the RfD represents the level at

or below which daily aggregate dietary

exposure over a lifetime will not pose

appreciable risks to human health.

Despite the potential for exposure to

sethoxydim in drinking water and from

non-dietary, non-occupational exposure,

EPA does not expect the aggregate

exposure to exceed 100% of the RfD.

EPA concludes that there is a reasonable

certainty that no harm will result to

infants and children from aggregate

exposure to sethoxydim residues.

V. Other Considerations

A. Metabolism In Plants and Animals

The nature of the residue in plants

and animals is adequately understood.

The residue of concern is the combined

residues of sethoxydim and its

metabolites containing the 2-

cyclohexen-1-one moiety (calculated as

the herbicide), as specified in 40 CFR

180.412.

B. Analytical Enforcement Methodology

Adequate enforcement methodology

(GLC/FPD-S) is available (Method I,

Pesticide Analytical Manual, Vol. II) to

enforce the tolerance expression.

C. Magnitude of Residues

Combined residues of sethoxydim and

its regulated metabolites are not

expected to exceed 4 ppm in/on

horseradish as a result of this Section 18

use. A time-limited tolerance should be

established for the regulable residue in/

on horseradish at 4 ppm. There are no

processed commodities from

horseradish. Secondary residues are not

expected in animal commodities as a

result of this Section 18 use, as no

livestock feed items are associated with

horseradish.

D. International Residue Limits

There are no Codex residue limits

established for sethoxydim, and no

Canadian or Mexican residue limits for

sethoxydim use on horseradish.

Harmonization is thus not an issue for

this Section 18 action.

E. Rotational Crop Restrictions.

There are no rotational crop

restrictions associated with this use, and

none are required As stated previously,

sethoxydim is a non-persistent, highly

mobile compound in soil and water

environments.

VI. Conclusion

Therefore, the tolerance is established

for residues of sethoxydim and its

metabolites containing the 2-

cyclohexen-1-one moiety in or on

horseradish at 4 ppm.

VII. Objections and Hearing Requests

The new FFDCA section 408(g)

provides essentially the same process

for persons to ‘‘object’’ to a tolerance

regulation issued by EPA under new

section 408(e) and (l)(6) as was provided

in the old section 408 and in section

409. However, the period for filing

objections is 60 days, rather than 30

days. EPA currently has procedural

regulations which govern the

submission of objections and hearing

requests. These regulations will require

some modification to reflect the new

law. However, until those modifications

can be made, EPA will continue to use

those procedural regulations with

appropriate adjustments to reflect the

new law.

Any person may, by October 21, 1997,

file written objections to any aspect of

this regulation and may also request a

hearing on those objections. Objections

and hearing requests must be filed with

the Hearing Clerk, at the address given

above (40 CFR 178.20). A copy of the

objections and/or hearing requests filed

with the Hearing Clerk should be

submitted to the OPP docket for this

rulemaking. The objections submitted

must specify the provisions of the

regulation deemed objectionable and the

grounds for the objections (40 CFR

178.25). Each objection must be

accompanied by the fee prescribed by

40 CFR 180.33(i). If a hearing is

requested, the objections must include a

statement of the factual issues on which

a hearing is requested, the requestor’s

contentions on such issues, and a

summary of any evidence relied upon

by the requestor (40 CFR 178.27). A

request for a hearing will be granted if

the Administrator determines that the

material submitted shows the following:

There is genuine and substantial issue

of fact; there is a reasonable possibility

that available evidence identified by the

requestor would, if established, resolve

one or more of such issues in favor of

the requestor, taking into account

uncontested claims or facts to the

contrary; and resolution of the factual

issues in the manner sought by the

requestor would be adequate to justify

the action requested (40 CFR 178.32).

Information submitted in connection

with an objection or hearing request

may be claimed confidential by marking

any part or all of that information as

Confidential Business Information (CBI).

Information so marked will not be

disclosed except in accordance with

procedures set forth in 40 CFR part 2.

A copy of the information 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.

VIII. Public Docket

EPA has established a record for this

rulemaking under docket control

number [OPP–300533] (including any

comments and data submitted

electronically). 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

Room 1132 of the Public Information

and Records Integrity Branch,

Information Resources and Services

Division (7506C), Office of Pesticide

Programs, Environmental Protection

Agency, Crystal Mall #2, 1921 Jefferson

Davis Hwy., Arlington, VA.

Electronic comments may 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 any copies of objections and

hearing requests 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 Virginia

address in ‘‘ADDRESSES’’ at the

beginning of this document.

IX. Regulatory Assessment

Requirements

This final rule establishes a timelimited tolerance under FFDCA section

408(l)(6). The Office of Management and

Budget (OMB) has exempted these types

of actions from review under Executive

Order 12866, entitled Regulatory

Planning and Review (58 FR 51735,

October 4, 1993). This final rule does

not contain any information collections

subject to OMB approval under the

Paperwork Reduction Act (PRA), 44
Federal Register / Vol. 62, No. 163 / Friday, August 22, 1997 / Rules and Regulations 44565

U.S.C. 3501 et seq., or impose any

enforceable duty or contain any

unfunded mandate as described under

Title II of the Unfunded Mandates

Reform Act of 1995 (UMRA) (Pub. L.

104-4). Nor does it require any prior

consultation as specified by Executive

Order 12875, entitled Enhancing the

Intergovernmental Partnership (58 FR

58093, October 28, 1993), or special

considerations as required by Executive

Order 12898, entitled Federal Actions to

Address Environmental Justice in

Minority Populations and Low-Income

Populations (59 FR 7629, February 16,

1994), or require OMB review in

accordance with Executive Order 13045,

entitled Protection of Children from

Environmental Health Risks and Safety

Risks (62 FR 19885, April 23, 1997).

In addition, since these tolerances and

exemptions that are established under

FFDCA section 408 (l)(6), such as the

tolerance in this final rule, do not

require the issuance of a proposed rule,

the requirements of the Regulatory

Flexibility Act (RFA) (5 U.S.C. 601 et

seq.) do not apply. Nevertheless, the

Agency has previously assessed whether

establishing tolerances, exemptions

from tolerances, raising tolerance levels

or expanding exemptions might

adversely impact small entities and

concluded, as a generic matter, that

there is no adverse economic impact.

The factual basis for the Agency’s

generic certification for tolerance

acations published on May 4, 1981 (46

FR 24950), and was provided to the

Chief Counsel for Advocacy of the Small

Business Administration.

X. Submission to Congress and the

General Accounting Office

Under 5 U.S.C. 801(a)(1)(A), as added

by the Small Business Regulatory

Enforcement Fairness Act of 1996, the

Agency has submitted a report

containing this rule and other required

information to the U.S. Senate, the U.S.

House of Representatives, and the

Comptroller General of the General

Accounting Office prior to publication

of this rule in today’s Federal Register.

This is not a ‘‘major rule’’ as defined by

5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

Environmental protection,

Administrative practice and procedure,

Agricultural commodities, Pesticides

and pests, Reporting and recordkeeping

requirements.

Dated: August 15, 1997.

Peter Caulkins,

Acting Director, Registration Division, Office

of Pesticide Programs.

Therefore, 40 CFR chapter I is

amended as follows:

PART 180—[AMENDED]

1. The authority citation for part 180

continues to read as follows:

Authority: 21 U.S.C. 346a and 371.

2. In § 180.412, by adding text to

paragraph (b) to read as follows:

§ 180.412 Sethoxydim: tolerance for

residues.

* * * * *

(b) Section 18 emergency exemptions.

A time-limited tolerance is established

for combined residues of the herbicide

sethoxydim and its metabolites

containing the 2-cyclohexen-1-one

moiety, calculated as the herbicide in

connection with use of the pesticide

under section 18 emergency exemptions

granted by EPA. This tolerance will

expire and is revoked on the date

specified in the following table:

Commodity Parts per million Expiration/revocation date

Horseradish ......................................................................................... 4 September 30, 1998

* * * * *

[FR Doc. 97–22377 Filed 8–21–97; 8:45 am]

BILLING CODE 6560–50–F

ENVIRONMENTAL PROTECTION

AGENCY

40 CFR Part 180

[OPP–300529; FRL–5737–7]

RIN 2070–AB78

Chlorfenapyr; Pesticide Tolerances for

Emergency Exemptions

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Final rule.

SUMMARY: This regulation establishes

time-limited tolerances for chlorfenapyr

in or on cottonseed; cotton gin

byproducts; milk; milk fat; meat of

cattle, goats, hogs, horses, and sheep; fat

of cattle, goats, hogs, horses, and sheep;

and meat byproducts of cattle, goats,

hogs, horses and sheep. This action is in

response to EPA’s granting of emergency

exemptions under section 18 of the

Federal Insecticide, Fungicide, and

Rodenticide Act authorizing use of the

pesticide on cotton. This regulation

establishes maximum permissible level

for residues of chlorfenapyr in/on these

food commodities pursuant to section

408(l)(6) of the Federal Food, Drug, and

Cosmetic Act, as amended by the Food

Quality Protection Act of 1996. These

tolerances will expire and are revoked

on July 31, 1999.

DATES: This regulation is effective

August 22, 1997. Objections and

requests for hearings must be received

by EPA on or before October 21, 1997.

ADDRESSES: Written objections and

hearing requests, identified by the

docket control number, [OPP–300529],

must be submitted to: Hearing Clerk

(1900), Environmental Protection

Agency, Rm. M3708, 401 M St., SW.,

Washington, DC 20460. Fees

accompanying objections and hearing

requests shall be labeled ‘‘Tolerance

Petition Fees’’ and forwarded to: EPA

Headquarters Accounting Operations

Branch, OPP (Tolerance Fees), P.O. Box

360277M, Pittsburgh, PA 15251. A copy

of any objections and hearing requests

filed with the Hearing Clerk identified

by the docket control number, [OPP–

300529], must also be submitted to:

Public Information and Records

Integrity Branch, Information Resources

and Services Division (7506C), Office of

Pesticide Programs, Environmental

Protection Agency, 401 M St., SW.,

Washington, DC 20460. In person, bring

a copy of objections and hearing

requests to Rm. 1132, CM #2, 1921

Jefferson Davis Hwy., Arlington, VA.

A copy of objections and hearing

requests filed with the Hearing Clerk

may also be submitted electronically by

sending electronic mail (e-mail) to: oppdocket@epamail.epa.gov. Copies of

objections and hearing requests must be

submitted as an ASCII file avoiding the

use of special characters and any form

of encryption. Copies of objections and

hearing requests will also be accepted

on disks in WordPerfect 5.1 file format

or ASCII file format. All copies of

objections and hearing requests in

electronic form must be identified by

the docket control number [OPP–

300529]. No Confidential Business