66008 Federal Register / Vol. 62, No. 242 / Wednesday, December 17, 1997 / Rules and Regulations

PART 52—[AMENDED]

1. The authority citation for part 52

continues to read as follows:

Authority: 42 U.S.C. 7401 et seq.

Subpart G—Colorado

2. Section 52.332 is amended by

redesignating paragraph (b) as paragraph

(b)(1), redesignating paragraph (e) as

paragraph (e)(1), and adding paragraphs

(b)(2) and (e)(2) to read as follows:

§ 52.332 Moderate PM–10 nonattainment

area plans.

* * * * *

(b) * * *

(2) On August 2, 1996, the Governor

of Colorado submitted minor revisions

to the Pagosa Springs Element of the

Colorado PM–10 SIP.

* * * * *

(e) * * *

(2) On March 13, 1995, the Governor

of Colorado submitted minor revisions

to the Aspen Element of the Colorado

PM–10 SIP.

* * * * *

[FR Doc. 97–32930 Filed 12–16–97; 8:45 am]

BILLING CODE 6560–50–P

ENVIRONMENTAL PROTECTION

AGENCY

40 CFR Part 180

[OPP–300585; FRL 5756–4]

RIN 2070–AB78

Ethalfluralin; Pesticide Tolerances for

Emergency Exemptions

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Final Rule.

SUMMARY: This regulation establishes a

time-limited tolerance for residues of

ethalfluralin in or on canola seed. This

action is in response to EPA allowing

issuance of crisis emergency exemptions

under section 18 of the Federal

Insecticide, Fungicide, and Rodenticide

Act authorizing use of the pesticide on

canola in Montana and North Dakota.

This regulation establishes a maximum

permissible level for residues of

ethalfluralin 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 October

31, 1998.

DATES: This regulation is effective

December 17, 1997. Objections and

requests for hearings must be received

by EPA on or before February 17, 1998.

ADDRESSES: Written objections and

hearing requests, identified by the

docket control number, [OPP–300585],

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–

300585], must also be submitted to:

Public Information and Records

Integrity Branch, Information Resources

and Services Division (7502C), 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 5.1/6.1 or

ASCII file format. All copies of

objections and hearing requests in

electronic form must be identified by

the docket control number [OPP–

300585]. 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: Andrea Beard, 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) 308–9356; e-mail:

beard.andrea@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

ethalfluralin, in or on canola seed at

0.05 part per million (ppm). This

tolerance will expire and is revoked on

October 31, 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
Federal Register / Vol. 62, No. 242 / Wednesday, December 17, 1997 / Rules and Regulations 66009

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

Ethalfluralin on Canola and FFDCA

Tolerances

The Applicants state that as canola

acreage has grown, wild buckwheat has

become an increasingly significant weed

pest, and that the only available

herbicide, trifluralin, does not provided

adequate control of this weed. Thus, the

Applicants found it necessary to issue

crisis exemptions for this use of

ethalfluralin, to avoid significant

economic loss. EPA has authorized

under FIFRA section 18 (the crisis

provisions) the use of ethalfluralin on

canola for control of wild buckwheat in

Montana and North Dakota.

As part of its assessment of this

emergency exemption, EPA assessed the

potential risks presented by residues of

ethalfluralin in or on canola seed. 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 October 31,

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 canola seed

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 ethalfluralin meets EPA’s

registration requirements for use on

canola 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

ethalfluralin 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 Montana or North

Dakota 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 ethalfluralin,

contact the Agency’s Registration

Division at the address provided above.

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
66010 Federal Register / Vol. 62, No. 242 / Wednesday, December 17, 1997 / Rules and Regulations

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

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

non-nursing infants, < 1 year 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 ethalfluralin and to make a

determination on aggregate exposure,

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

time-limited tolerance for residues of

ethalfluralin on canola seed at 0.05

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 ethalfluralin are

discussed below.

1. Acute toxicity. For acute dietary

risk assessment, EPA scientists have

determined that the developmental

NOEL of 75 mg/kg/day, from the rabbit

developmental study should be used.

The LOEL of 150 mg/kg/day is based on

increased number of resorptions and

increased sternal and cranial variations.

Since the effect of concern is

reproductive in nature, the acute risk

assessment will evaluate acute dietary

risk to the population subgroup of

concern, females 13 + years old.

2. Short - and intermediate - term

toxicity. No short- or intermediate-term

toxicity endpoints have been identified

for ethalfluralin, and OPP scientists

determined that this assessment is not

necessary.

3. Chronic toxicity. EPA has

established the RfD for ethalfluralin at

0.04 milligrams/kilogram/day (mg/kg/

day). This RfD is based on a 1–year

feeding study in dogs with a NOEL of

4.0 mg/kg/day, and an uncertainty factor

of 100. The LOEL of 20 mg/kg/day was

based upon altered red cell morphology

and urinary bilirubin.

4. Carcinogenicity. Based on

mammary gland fibroadenomas and

combined mammary gland adenomas

and/or fibroadenomas in female rats,

ethalfluralin has been classified in

Group C possible human carcinogen,

according to EPA’s Cancer Assessment

Guidelines. The OPP Cancer Peer

Review Committee recommended using

the Q* approach for risk assessment,

and the Q* of 8.9 × 10-2 has been

calculated.

B. Exposures and Risks

1. From food and feed uses.

Tolerances have been established (40

CFR 180.416) for the residues of

ethalfluralin, in or on the following raw

agricultural commodities: dry beans and

peas, cucurbit vegetables, peanuts,

soybeans, and sunflower seeds; and in

animal commodities fat, meat, and meat

byproducts of cattle, goats, hogs, horses,

poultry, and sheep; and milk and eggs.

According to the Ethalfluralin

Reregistration Eligibility Document

(RED), published March 1995, EPA is

requiring revocation of all animal

commodity tolerances, as they are not

needed there is no expectation of finite

residues. In the following risk

assessments, the animal commodity

tolerances are included, and then

subsequently excluded from the refined

cancer risk assessment. Risk

assessments were conducted by EPA to
Federal Register / Vol. 62, No. 242 / Wednesday, December 17, 1997 / Rules and Regulations 66011

assess dietary exposures and risks from

ethalfluralin as follows:

i. Acute exposure and risk. 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. The acute

risk assessment used tolerance-level

residues for all commodities having

ethalfluralin tolerances. For the

population subgroup of concern,

females 13 + years old, the Margin of

Exposure (MOE) for the high-end

consumer was calculated to be 25,000

(an MOE of ≤ 100 represents a negligible

risk. Canola seed is processed into

canola oil, a commodity which is not

listed in OPP’s dietary risk exposure

system (DRES), so a standard DRES risk

analysis including it cannot be

conducted. However, canola oil is a very

low consumption human food item

0.01% of the RfD, see below, and would

be expected to contribute only a minor

incremental increase to the acute dietary

exposure. Additionally, the estimate

given above should be considered

extremely conservative, and if it were

refined, using a Monte Carlo technique

and incorporating anticipated residues

and percent of crop treated figures, the

MOEs would likely be much higher.

ii. Chronic exposure and risk. The

chronic dietary (food only) risk

assessment for ethalfluralin was

conducted using anticipated residue

values and percent of crop treated

information for some of the crops. Based

on this, EPA has concluded that dietary

exposure to ethalfluralin will utilize 2%

of the RfD for the Overall US Population

0.01% of this attributed to canola oil.

The major identifiable subgroup with

the highest exposure is non-nursing

infants < 1 year old, at 9% of the RfD.

This is further discussed below in the

section on infants and children. EPA

generally has no concern for exposure

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 ethalfluralin in drinking

water. EPA does not expect the

aggregate exposure to exceed 100% of

the RfD.

2. From drinking water. According to

available data, ethalfluralin is

moderately persistent and relatively

immobile in soil, and is not expected to

be a groundwater contaminant.

Ethalfluralin does appear to have some

potential to reach surface waters on

eroded soil particles, but in surface

waters, ethalfluralin would be expected

to photodegrade rapidly. According to

EPA’s Pesticides in Ground Water

Database, a total of 188 wells in Texas

were monitored for ethalfluralin

residues in 1987–88, and no detectable

residues were reported. There are no

Maximum Contaminant Levels or

Health Advisory Levels established for

ethalfluralin in drinking water.

Because the Agency lacks sufficient

water-related 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 (RfDs or acute

dietary NOELs) 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 ethalfluralin 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

ethalfluralin 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.

3. From non-dietary exposure.

Ethalfluralin is not currently registered

for use on any residential non-food

sites, and thus, it is not expected that

non-occupational, non-dietary

exposures will occur.

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.

Although ethalfluralin is a member of

the nitroaniline class of herbicides, EPA

does not have, at this time, available

data to determine whether ethalfluralin

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, ethalfluralin

does not appear to produce a toxic

metabolite produced by other

substances. For the purposes of this

tolerance action, therefore, EPA has not

assumed that ethalfluralin has a

common mechanism of toxicity with

other substances.

C. Aggregate Risks and Determination of

Safety for U.S. Population

1. Acute risk. For the population

subgroup of concern, females 13 + years

old, the calculated MOE value for

dietary exposure from food only is
66012 Federal Register / Vol. 62, No. 242 / Wednesday, December 17, 1997 / Rules and Regulations

25,000. Although there is potential for

exposure to ethalfluralin in drinking

water, EPA does not expect that this

would result in an aggregate MOE food

plus water that would exceed the level

of concern MOE < 100 for acute dietary

exposure. Therefore, EPA concludes

that there is reasonable certainty that no

harm will result from aggregate acute

exposure to ethalfluralin.

2. Chronic risk. Using the ARC

exposure assumptions described above,

EPA has concluded that aggregate

exposure to ethalfluralin from food will

utilize 2% of the RfD for the U.S.

population. The major identifiable

subgroup with the highest aggregate

exposure is non-nursing infants < 1 year

old, at 9% of the RfD, discussed below.

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

ethalfluralin 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 from

aggregate chronic exposure to

ethalfluralin residues.

D. Aggregate Cancer Risk for U.S.

Population

Based on the Q* of 0.089 (mg/kg/

day)-1, and the anticipated residue

contribution, the upper bound cancer

risk estimate for the U.S. population is

6.2 × 10-5, contributed through all the

published tolerances for ethalfluralin.

However, as stated above, EPA is

requiring revocation of the ethalfluralin

tolerances for meat, milk, poultry, and

eggs, due to the presumption that there

are undetectable residues in these food

items. When the cancer risk is

calculated excluding these animal

commodity tolerances, the resulting

upper bound risk is 5.7 × 10-7, which is

considered a negligible risk. This cancer

risk analysis does not include canola

oil, which is not covered by the DRES

analysis. However, the consumption of

canola oil has been calculated to

comprise only 0.01% of the RfD, and

thus, in the best scientific judgment of

EPA, would not contribute appreciably

to the dietary cancer risk from food uses

of ethalfluralin.

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

ethalfluralin, EPA considered data from

developmental toxicity studies in the rat

and rabbit and a 3-generation

reproduction study in the rat, and a 7-

month multigeneration study in rats.

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 10–fold

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

safely factor usually 100 for combined

inter- and intra-species variability and

not the additional 10–fold 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. In

the developmental toxicity study in rats,

the maternal systemic NOEL was 50 mg/

kg/day, based on decreased body weight

gain and dark urine at the LOEL of 250

mg/kg/day. The fetal developmental

NOEL was 1000 mg/kg/day, at the

highest dose tested (no effects observed

to the fetuses).

In the developmental toxicity study in

rabbits, the maternal systemic NOEL

was 75 mg/kg/day, based on abortions

and decreased food consumption at the

LOEL of 150 mg/kg/day. The fetal

developmental NOEL was also 75 mg/

kg/day, based on a slightly increased

number of resorptions, abnormal cranial

development, and increased sternal

variants, at the LOEL of 150 mg/kg/day.

iii. Reproductive toxicity study. In a 3-

generation reproductive toxicity study

in rats, the parental systemic NOEL was

12.5 mg/kg/day, based on decreased

mean body weight gains in males in all

generations, at the LOEL of 37.5 mg/kg/

day. The pup reproductive NOEL was

37.5 mg/kg/day, the highest dose tested

no effects seen on the pups.

In a 7-month multigeneration study in

rats, the parental NOEL of 20 mg/kg/day

was based on increased liver weights at

the LOEL of 61 mg/kg/day. The pup

reproductive NOEL was ≤ 61 mg/kg/day,

the highest dose tested no effects seen

on the pups.

iv. Pre- and post-natal sensitivity. The

toxicological data base for evaluating

pre- and post-natal effects is complete

for ethalfluralin. Based on the results of

the developmental and reproduction

studies outlined above, there are no preor post-natal toxicity concerns for

infants and children, from exposure to

ethalfluralin.

v. Conclusion. Since no pre-or postnatal concerns have been identified for

ethalfluralin, EPA scientists conclude

that reliable data support use of the

standard 100–fold uncertainty factor,

and an additional uncertainty factor is

not needed to protect infants and

children.

2. Acute risk. For the population

subgroup of concern, females 13 + years

old, the MOE for ethalfluralin dietary

(food only) exposure is 25,000; this

accounts for both maternal and fetal

exposure. Although there is potential for

exposure to ethalfluralin in drinking

water, EPA does not expect that this

would result in an aggregate MOE (food

plus water) that would exceed the level

of concern MOE < 100 for acute dietary

exposure. Therefore, EPA concludes

that there is reasonable certainty that no

harm will result, for both Females 13+

Years Old, and for the pre-natal

development of infants, from aggregate

acute exposure to ethalfluralin.

3. Chronic risk. Using the

conservative exposure assumptions

described above, EPA has concluded

that aggregate exposure to ethalfluralin

from food will utilize 9% of the RfD for

the highest exposed subgroup of infants

and children, non-nursing infants, < 1

year old. 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

ethalfluralin 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

chronic exposure to ethalfluralin

residues.
Federal Register / Vol. 62, No. 242 / Wednesday, December 17, 1997 / Rules and Regulations 66013

V. Other Considerations

A. Metabolism In Plants and Animals

The nature of the residue of

ethalfluralin in plants and animals is

adequately understood; the residue of

concern is ethalfluralin per se, as

specified in 40 CFR 180.416.

B. Analytical Enforcement Methodology

Adequate enforcement methods gasliquid chromatography with electron

capture detection are available to

enforce the tolerance, in both plant and

animal tissues, and are listed in the

Pesticide Analytical Manual, Volume II

PAM-II.

C. Magnitude of Residues

Residues of ethalfluralin are not

expected to exceed 0.05 ppm in/on

canola seed as a result of this section 18

use. Residues are not expected to

concentrate in the processed

commodities meal, refined oil of canola,

and no tolerances are required for these

commodities.

D. International Residue Limits

There are no Codex, Canadian, or

Mexican maximum residue limits

established for ethalfluralin.

E. Rotational Crop Restrictions

There are no plantback restrictions

needed, and tolerances for rotational

crop commodities need not be

established.

VI. Conclusion

Therefore, the tolerance is established

for residues of ethalfluralin in canola

seed at 0.05 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 February 17,

1998, 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

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–-300585] (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 (7502C), Office of Pesticide

Programs, Environmental Protection

Agency, Crystal Mall #2, 1921 Jefferson

Davis Highway, 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

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

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
66014 Federal Register / Vol. 62, No. 242 / Wednesday, December 17, 1997 / Rules and Regulations

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: November 25, 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. Section 180.416, is amended as

follows:

i. By designating the existing text as

paragraph (a) and adding a heading.

ii. By adding a new paragraph (b).

iii. By adding and reserving new

paragraphs (c) and (d) with headings to

read as follows.

§180.416 Ethalfluralin; tolerances for

residues.

(a) General. * * *

(b) Section 18 emergency exemptions.

Time-limited tolerances are established

for the residues of the herbicide

ethalfluralin, in connection with use of

the pesticide under section 18

emergency exemptions granted by EPA.

The tolerances will expire on the dates

specified in the following table.

Commodity Parts per million Expiration/revocation date

Canola, seed ....................................................................................... 0.05 10/31/98

(c) Tolerances with regional

registrations. [Reserved]

(d) Indirect or inadvertent residues.

[Reserved]

[FR Doc. 97–32933 Filed 12–16–97; 8:45 am]

BILLING CODE 6560–50–F

ENVIRONMENTAL PROTECTION

AGENCY

40 CFR Part 180

[OPP–300573; FRL 5753–6]

RIN 2070–AB78

Primisulfuron-methyl; Pesticide

Tolerances for Emergency Exemptions

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Final Rule.

SUMMARY: This regulation establishes a

time-limited tolerance for residues of

primisulfuron-methyl in or on bluegrass

grown for seed. 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 bluegrass grown for

seed. This regulation establishes a

maximum permissible level for residues

of primisulfuron-methyl 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 October

31, 1998.

DATES: This regulation is effective

December 17, 1997. Objections and

requests for hearings must be received

by EPA on or before February 17, 1998.

ADDRESSES: Written objections and

hearing requests, identified by the

docket control number, [OPP–300573],

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–

300573], must also be submitted to:

Public Information and Records

Integrity Branch, Information Resources

and Services Division (7502C), 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 5.1/6.1 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–

300573]. 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: Pat Cimino, 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) 308–9357; e-mail:

cimino.pat@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

primisulfuron-methyl, in or on

bluegrass grown for seed at 0.10 parts

per million (ppm). This tolerance will

expire and is revoked on October 31,

1998. EPA will publish a document in

the Federal Register to remove the

revoked tolerance from the Code of

Federal Regulations.