Federal Register / Vol. 63, No. 111 /Wednesday, June 10, 1998 /Rules and Regulations 31633

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.

II. Public Record and Electronic

Submissions

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

Electronic comments may be sent

directly to EPA at:

opp-docket@epamail.epa.gov.

Electronic objections and hearing

requests must be submitted as an ASCII

file avoiding the use of special

characters and any form of encryption.

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–300652]. No 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.

III. Regulatory Assessment

Requirements

This final rule extends a time-limited

tolerance that was previously extended

by EPA under FFDCA section 408(d) in

response to a petition submitted to the

Agency. 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). In addition, 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).

Since this extension of an existing

time-limited tolerance does 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.

IV. Submission to Congress and the

Comptroller General

The Congressional Review Act, 5

U.S.C. 801 et seq., as added by the Small

Business Regulatory Enforcement

Fairness Act of 1996, generally provides

that before a rule may take effect, the

Agency promulgating the rule must

submit a rule report, which includes a

copy of the rule, to each House of the

Congress and to the Comptroller General

of the United States. EPA will submit a

reportcontaining this rule and other

required information to the U.S. Senate,

the U.S. House of Representatives, and

the Comptroller General of the United

States prior to publication of this rule in

the Federal Register. This rule 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: May 21, 1998.

James Jones,

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 § 180.364, by revising paragraph

(b) to read as follows:

§ 180.364 Glyphosate; tolerances for

residues.

* * * * *

(b) Section 18 emergency exemptions.

Time-limited tolerances are established

for combined residues of the herbicide

glyphosate, per se in connection with

use of the pesticide under section 18

emergency exemptions granted by EPA.

The tolerances will expire and are

revoked on the dates specified in the

following table.

Commodity Parts per

million

Expiration/

revocation

date

Cattle, kidney .... 4 2/29/00

Chickpeas ......... 5 2/29/00

Goats, kidney .... 4 2/29/00

Horses, kidney .. 4 2/29/00

Lentils ................ 5 2/29/00

Pea, hay ............ 200 2/29/00

Pea, vines ......... 60 2/29/00

Peas, dry ........... 5 2/29/00

Sheep, kidney ... 4 2/29/00

Silage, hay ........ 90 2/29/00

* * * * *

[FR Doc. 98–15327 Filed 6–9–98; 8:45 am]

BILLING CODE 6560–50–F

ENVIRONMENTAL PROTECTION

AGENCY

40 CFR Part 180

[OPP–300662; FRL 5791–5]

RIN 2070–AB78

Fenbuconazole; Pesticide Tolerances

for Emergency Exemptions

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Final rule.

SUMMARY: This regulation establishes a

time-limited tolerance for residues of

fenbuconazole and its metabolites in or

on blueberries. 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
31634 Federal Register / Vol. 63, No. 111 /Wednesday, June 10, 1998 /Rules and Regulations

the pesticide on blueberries in several

States. This regulation establishes a

maximum permissible level for residues

of fenbuconazole 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 December

31, 1999.

DATES: This regulation is effective June

10, 1998. Objections and requests for

hearings must be received by EPA on or

before August 10, 1998.

ADDRESSES: Written objections and

hearing requests, identified by the

docket control number, [OPP–300662],

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–

300662], 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. 119, 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–

300662]. 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: Daniel Rosenblatt, 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) 308–9375; e-mail:

rosenblatt.dan@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 the fungicide

fenbuconazole and its metabolites, in or

on blueberries at 1.0 part per million

(ppm). This tolerance will expire and is

revoked on December 31, 1999. 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

Fenbuconazole on Blueberries and

FFDCA Tolerances

Mummy berry disease Monilinia

vaccinii-corymbosi is a plant disease

which causes a variety of leaf, flower,

and fruit damage. Of special concern for

blueberry producers are the blighted

flower clusters on blueberry bushes and

mummified fruit that the disease will

produce. Yield loss projections suggest

that mummy berry disease may produce

losses of 25–50% of the blueberry crop.

In addition, the mummified fruit will

serve as the inoculum for subsequent

outbreaks of mummy berry disease so it

is important to gain control over the

pest in order to avert future problem

outbreaks.

In past growing seasons, blueberry

growers typically used triforine to

control mummy berry disease. However,

triforine was voluntarily canceled by its

manufacturer. Now that triforine

pesticides have been canceled, there do

not appear to be any registered

pesticidal or cultural measures that

growers can use. Therefore, EPA

concurs that the pressures presented by

mummy berry disease on blueberry

growers represent an urgent and nonroutine situation and has authorized

under FIFRA section 18 the use of

fenbuconazole on blueberries to

numerous States.

As part of its assessment of this

emergency exemption, EPA assessed the

potential risks presented by residues of

fenbuconazole in or on blueberries. In

doing so, EPA considered the new safety

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

and EPA decided that the necessary
Federal Register / Vol. 63, No. 111 /Wednesday, June 10, 1998 /Rules and Regulations 31635

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 December 31,

1999, under FFDCA section 408(l)(5),

residues of the pesticide not in excess

of the amounts specified in the

tolerance remaining in or on blueberries

after that date will not be unlawful,

provided the pesticide is applied in a

manner that was lawful under FIFRA,

and the residues do not exceed a level

that was authorized by this tolerance at

the time of that application. 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 fenbuconazole meets EPA’s

registration requirements for use on

blueberries 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

fenbuconazole by a State for special

local needs under FIFRA section 24(c).

Nor does this tolerance serve as the

basis for any States other than those

authorized under section 18 to use this

pesticide on this crop without following

all provisions of section 18 as identified

in 40 CFR part 166. For additional

information regarding the emergency

exemption for fenbuconazole, 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

aggregateexposure 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 three

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.)
31636 Federal Register / Vol. 63, No. 111 /Wednesday, June 10, 1998 /Rules and Regulations

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

(females 13 years and older) 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 fenbuconazole and to make a

determination on aggregate exposure,

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

time-limited tolerance for residues of

fenbuconazole and its metabolites on

blueberries at 1.0 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 fenbuconazole

are discussed below.

1. Acute toxicity. For the purposes of

the acute dietary risk assessment, EPA

assessments are based on an acute RfD

of 0.3 milligrams/kilogram/day (mg/kg/

day). This figure is derived from

developmental toxicity data from

laboratory animals where the NOEL was

determined to be 30 mg/kg/day. The

observed effect was a decrease in the

number of live fetuses at the Lowest

Effect Level (LEL) of 75 mg/kg/day and

an uncertainty factor of 100. EPA

determined that an additional safety

factor of 3x for the protection of infants

and children was appropriate.

Therefore, the FQPA acute allowable

risk is 0.1 mg/kg/day.

2. Short - and intermediate - term

toxicity. No dermal or systemic toxicity

endpoints were identified for this

exposure duration. Therefore, a risk

assessment is not needed.

3. Chronic toxicity. EPA has

established the RfD for fenbuconazole at

0.03 mg/kg/day. This RfD is based on a

chronic toxicity study in the rat with a

NOEL of 3.03/4.02 in males/females.

The NOEL is based on decreased body

weight gains (females), hepatocellular

enlargement and vaculation (females),

increases in thyroid weight (both sexes)

and histopathological lesions in the

thyroid glands (males), at the LEL of

30.62/43.04 mg/kg/day in males/

females. For the population subgroup of

infants and children an uncertainty

factor of 300 was used. The FQPA

chronic allowable risk is 0.01 mg/kg/day

for infants, children, and females 13

years and older.

4. Carcinogenicity. Using its

Guidelines for Carcinogen Risk

Assessment, EPA has classified

fenbuconazole as a Group C (possible

human carcinogen) chemical. EPA

believes it is appropriate to use the Q1

*

approach of 3.59 x 10-3 (mg/kg/day)-1.

B. Exposures and Risks

1. From food and feed uses.

Tolerances have been established (40

CFR 180.480) for the use of

fenbuconazole and its metabolites, in or

on a variety of raw agricultural

commodities. Time-limited tolerances

have been established for residues of

fenbuconazole, alpha-2-(4-

chlorophenyl)-ethyl-alpha-phenyl-3-

(1H-1,2,4-triazole)-1-propanenitrile] and

its metabolites, cis-5-(4-

chlorophenyl)dihydro-3-phenyl-3-(1H

1,2,4-triazole-1-ylmethyl-2-3H-furanone,

expressed as fenbuconazole in or on

commodities ranging from 0.1 ppm in

pecans to 2.0 ppm in the stone fruit crop

group. Risk assessments were conducted

by EPA to assess dietary exposures and

risks from fenbuconazole 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. In

conducting an acute dietary risk

assessment for fenbuconazole, EPA has

made conservative assumptions which

result in an overestimate of human

dietary exposure. The acute dietary

(food only) risk assessment used TMRC.

The resulting high-end exposure

estimate is 0.015 mg/kg/day. This

exposure level utilizes 15% of the

dietary (food only) FQPA acute

allowable risk for females 13+ years.

Refinement using anticipated residue

values and percent crop-treated data in

conjunction with Monte Carlo analysis

would result in lower acute dietary

exposure estimates.

ii. Chronic exposure and risk. The

chronic dietary risk assessment is

partially refined. Tolerance level

residues were assumed for all

commodities, including stone fruits.

Percent crop treated data were used for
Federal Register / Vol. 63, No. 111 /Wednesday, June 10, 1998 /Rules and Regulations 31637

stone fruits only and 100% crop-treated

data were used for all other

commodities. The existing tolerances for

fenbuconazole plus exposures

connected with the section 18 on

blueberries result in an anticipated

residue contribution (ARC) that is

equivalent to 3% of the RfD for nonnursing infants (<1 year old), the highest

exposed subpopulation.

2. From drinking water. There are no

established Maximum Contaminant

Level for residues of fenbuconazole in

drinking water and no health advisory

levels for fenbuconazole in drinking

water have been established.

Fenbuconazole is moderately

persistent and slightly mobile to

immobile in soil. Because of its

adsorption to soil, the potential for

fenbuconazole to leach to ground water

appears to be slight. However, the

potential to contaminate ground water

may be greater at vulnerable sites, where

soils are low in organic matter and

where ground water is relatively close to

the surface. The long half-lives of

aerobic soil and terrestrial field

dissipation indicate that when

fenbuconazole is applied over multiple

growing seasons, soil residue

accumulation may result. These

residues may be available for rotational

crop uptake or may be transported with

sediments during runoff events.

For the purposes of EPA’s water

screening assessments, it is assumed

that adult males weigh 70 kg, adult

females 60 kg, and children 10 kg.

Average consumption is assumed to be

2 liters/day for adults and 1 liter/day for

children.

EPA performed a ground water

assessment with its ground water

screening tool to establish an estimated

environmental concentration (EEC). The

Tier I estimate projected that the

concentration of fenbuconazole in

drinking water from ground water

sources is not likely to exceed an acute

and chronic EEC of 0.019 μg/l for

ground and aerial applications.

A Tier I drinking water assessment of

fenbuconazole was also conducted for

surface water. The EECs are generated

for high exposure agricultural scenarios

and correspond to a stagnant pond with

no outlet that receives pesticide loading

from an adjacent 100% cropped, 100%

treated field. As such, these computer

generated EECs represent conservative

screening levels for ponds and lakes and

are thought to represent an overestimate

of the actual EEC. The peak EEC

projection for surface water involved

aerial applications. The acute peak EEC

was 4.27 μg/l. The chronic 56–day EEC

was 2.29 μg/l. Because the surface water

EECs appear to be higher, EPA used

these worst case calculations in its

dietary risk assessment.

i. Acute exposure and risk. EPA

calculated the acute risks from drinking

water for fenbuconazole based on

dietary (food) exposure and the default

assumptions mentioned above. To

calculate the acute drinking water level

of concern (DWLOC), the acute dietary

food exposure estimate is subtracted

from the acute RfD.

The calculations were based on the

following: the acute RfD for

fenbuconazole is 0.3 mg/kg/day; the

FQPA acute allowable risk is 0.1 mg/kg/

day based on an uncertainty factor of 3.

If the acute food exposure estimate

(0.015 mg/kg/day) is subtracted from the

FQPA acute allowable risk (0.1 mg/kg/

day) the result is the maximum acute

water exposure which is 0.085 mg/kg/

day or 2,600 parts per billion (ppb).

The peak EEC (acute) value is 4.27

ppb, based on aerial application of

fenbuconazole. This figure is

significantly lower that the DWLOC of

2,600 ppb. Therefore, EPA concludes

with reasonable certainty that the acute

exposure to fenbuconazole in drinking

water is less than the level of concern.

ii. Chronic exposure and risk. To

calculate the chronic DWLOC, the

chronic dietary food exposure is

subtracted from the RfD. Chronic

DWLOCs were calculated for various

subpopulations ranging from 1,050 ppb

for the U.S. population to 92 ppb for

infants and children (non-nursing < 1

year). The computer model suggested

that the chronic EEC for fenbuconazole

is 2.29 ppb for aerial applications of the

pesticide. Since the EEC is less than the

DWLOC, EPA concludes that there is

reasonable certainty that chronic

exposure is less than the level of

concern.

EPA calculated the cancer risk

associated with fenbuconazole and

drinking water. To calculate the

DWLOC for cancer, the chronic dietary

food exposure was subtracted from the

negligible risk standard (1 x 10-6)

divided by the Q1

* (0.00359 mg/kg/day).

EPA’s drinking water level of concern

from cancer is 5.4 ppb for the U.S.

population. This compares to the level

of 2.29 ppb from the conservative

computer model EPA used to estimate

exposures. Since the DWLOC is higher

than the calculated EEC of 2.29 ppb,

EPA concludes with reasonable

certainty that exposure to fenbuconazole

in drinking water does not pose a level

of concern with respect to cancer risks.

3. From non-dietary exposure.

Fenbuconazole is not currently

registered for any residential or nonfood use sites. Therefore, a discussion of

the toxicity endpoints for non-dietary

exposure and a risk assessment for these

uses is not germane to this review.

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

fenbuconazole has a common

mechanism of toxicity with other
31638 Federal Register / Vol. 63, No. 111 /Wednesday, June 10, 1998 /Rules and Regulations

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, fenbuconazole

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 fenbuconazole 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

and older, EPA used the TMRC

approach and calculated that exposure

would utilize 15% of the RfD. EPA

generally has no concerns for exposures

below 100% of the acute RfD. In

addition, for acute exposures associated

with drinking water, EPA has concluded

that the level of concern is 2,600 ppb.

The EEC value is 4.27 ppb. This leads

EPA to conclude that acute exposure to

fenbuconazole does not pose a level of

concern.

2. Chronic risk. Using ARC exposure

assumptions, EPA has concluded that

aggregate exposure to fenbuconazole

from food will utilize less than 1% of

the RfD for the U.S. population. The

major identifiable subgroup with the

highest aggregate exposure is nonnursing infants where 3% of the RfD is

utilized. A full discussion of the risks

associated with exposure to infants and

children is presented 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. EPA’s level of concern

from chronic exposure to drinking water

is 1,050 ppb for the U.S. population.

The EEC for aerial application is

projected to be 2.29 ppb. Therefore, EPA

concludes that there is a reasonable

certainty that no harm will result from

aggregate exposure to fenbuconazole

residues.

3. Short- and intermediate-term risk.

Short- and intermediate-term endpoints

were not identified for fenbuconazole.

Therefore, an aggregate risk assessment

was not conducted for these endpoints.

Furthermore, fenbuconazole has no

residential uses.

D. Aggregate Cancer Risk for U.S.

Population

Fenbuconazole has been classified as

a Group C Carcinogen with a Q1

* of 3.59

x 10-3 (0.00359 mg/kg/day). The Q*

approach was used for risk assessments

involving carcinogenic effects. Using

partially refined exposure estimates, the

cancer risk estimate for the U.S.

population is 3.25 x 10-7. For exposures

connected with drinking water, EPA’s

level of concern is 5.4 ppb. EPA projects

that the EEC for fenbuconazole is 2.29

ppb. Therefore, EPA concludes with

reasonable certainty that exposure to

fenbuconazole does not exceed the level

of concern for cancer risks.

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

fenbuconazole, EPA considered data

from developmental toxicity studies in

the rat and rabbit and a 2-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 MOE and

uncertainty factor (usually 100 for

combined inter- and intra-species

variability) and not the additional

tenfold MOE/uncertainty 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 MOE/safety factor.

ii. Developmental toxicity studies. In

the developmental toxicity study in rats,

the maternal (systemic) NOEL was 30

mg/kg/day, based on decreases in body

weight and body weight gain at the

LOEL of 75 mg/kg/day. The

developmental (fetal) NOEL was 30 mg/

kg/day, based on an increase in post

implantation loss and a significant

decrease in the number of live fetuses

per dam at the LOEL of 75 mg/kg/day.

In the developmental toxicity study in

rabbits, the maternal (systemic) NOEL

was 10 mg/kg/day, based on decreased

body weight gain at the LOEL of 30 mg/

kg/day. The developmental (pup) NOEL

was 30 mg/kg/day, based on increased

resorptions at the LOEL of 60 mg/kg/

day.

iii. Reproductive toxicity study. In the

2-generation reproductive study in rats,

the paternal (systemic) NOEL was 4 mg/

kg/day, based on decreased body weight

and food consumption, increased

number of dams not delivering viable or

delivering nonviable offspring, and

increases in adrenal and thyroid weights

at the LOEL of 40 mg/kg/day. The

reproductive (pup) NOEL was 40 mg/kg/

day, the highest dose tested (HDT).

iv. Pre- and post-natal sensitivity. The

toxicological data base for evaluating

pre-and post-natal toxicity for

fenbuconazole is complete with respect

to EPA’s current data requirements.

Based on the developmental and

reproductive toxicity studies there is not

adequate evidence to completely

remove the FQPA 10x factor. There is

some evidence suggestive of increased

susceptibility in developing offspring.

An increase in post implantation loss

and a significant decrease in the number

of live fetuses per dam in rats in the

presence of effects on maternal weight

gain may be indicative of increased

susceptibility in the fetus. However, the

increased incidence does not appear to

be very great at 75 mg/kg/day for either

effect. Similarly, in rabbits there are

reported resorptions at 60 mg/kg/day

and effects on maternal weight gain at

30 mg/kg/day. Therefore, EPA

determined that the 10x factor required

by FQPA for protection of infants and

children from exposure to

fenbuconazole should be reduced to 3x.

The retention of the 3x factor for this

risk assessment does not result in

exposure values which exceed EPA’s

level of concern. This action should not

pose an unacceptable aggregate risk to

infants and children.

2. Acute risk. Toxicological effects

relevant to infants and children that

could be attributed to a single exposure

(dose) were not observed in oral toxicity

studies including the developmental

toxicity studies in rats and rabbits. A

dose and endpoint was not identified.

Therefore, an aggregate risk assessment

is not required for this subpopulation.

3. Chronic risk. Using ARC exposure

assumptions, EPA has concluded that

aggregate exposure to fenbuconazole

from food will utilize 3% of the RfD for

non-nursing infants less than 1 year old

to less than 1% for children 1–6 years

old. EPA generally has no concern for

exposures below 100% of the RfD
Federal Register / Vol. 63, No. 111 /Wednesday, June 10, 1998 /Rules and Regulations 31639

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.

EPA’s level of concern for chronic

exposure to infants and children

through drinking water is 92 ppb. EPA’s

water exposure model suggests that

aerial application could result in an EEC

of 2.29 ppb. Therefore, EPA concludes

that there is a reasonable certainty that

no harm will result to infants and

children from aggregate exposure to

fenbuconazole residues.

V. Other Considerations

A. Metabolism In Plants and Animals

The nature of the residue of

fenbuconazole for this action is

adequately understood. The residue of

concern is fenbuconazole (alpha-[2-4-

chlorophenyl)-ethyl]alpha-phenyl-3-

(1H-1,2,4-triazole)-1-propanenitrile] and

its metabolites, cis-5-(4-

chlorophenyl)dihydro-3-phenyl-3-(1H1,2,4-triazole-1-ylmethyl)-2-3Hfuranoneandtrans-5-(4-

chlorophenyl)dihydro-3-phenyl-3-(1H1,2,4-triazole-1-ylmethyl)-2-3Hfuranone, expressed as fenbuconazole as

specified in 40 CFR 180.480.

No livestock feed items are associated

with this request. Thus, the nature of

the residue in livestock is not of

concern.

B. Analytical Enforcement Methodology

Analytical methodology is available to

enforce the tolerances forfenbuconazole.

C. Magnitude of Residues

Residues of fenbuconazole and its

regulated metabolites are not expected

to exceed 1.0 ppm in/on blueberries.

Secondary residues are not expected as

no livestock feed items are associated

with this use.

D. International Residue Limits

There are no CODEX, Canadian, or

Mexican maximum residue limits

(MRLs) for fenbuconazole on

blueberries.

E. Rotational Crop Restrictions

Blueberries are not rotated. Rotational

crop restrictions are not germane to this

action.

VI. Conclusion

Therefore, the tolerance is established

for residues of fenbuconazole (alpha-[2-

4-chlorophenyl)-ethyl]alpha-phenyl-3-

(1H-1,2,4-triazole)-1-propanenitrile] and

its metabolites, cis-5-(4-chlorophenyl)-

dihydro-3-phenyl-3-(1H-1,2,4-triazole-1-

ylmethyl)-2-3H-furanone and trans-5-(4-

chlorophenyl)dihydro-3-phenyl-3-(1H

1,2,4-triazole-1-ylmethyl-2-3H-furanone,

expressed as fenbuconazole in

blueberries at 1.0 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 August 10, 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 Record and Electronic

Submissions

EPA has established a record for this

rulemaking under docket control

number [OPP–300662] (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 119 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

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 tolerance

under FFDCA section 408(d) in

response to a petition submitted to the

Agency. 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
31640 Federal Register / Vol. 63, No. 111 /Wednesday, June 10, 1998 /Rules and Regulations

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: May 20, 1998.

James Jones,

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 180.480 is amended by

adding a heading to paragraph (a); by

designating the text in paragraph (a) as

paragraph (a)(1); by redesignating

paragraph (b) as paragraph (a)(2) and

amending it to revise the phrase

‘‘paragraph (a) of this section’’ to read

‘‘paragraph (a)(1) of this section’’; by

adding a new paragraph (b); and by

adding and reserving with headings

paragraphs (c) and (d) to read as follows:

§ 180.480 Fenbuconazole; tolerances for

residues.

(a) General. (1) * * *

(2) * * *

(b) Section 18 emergency exemptions.

A time-limited tolerance is established

for fenbuconazole (alpha-[2-4-

chlorophenyl)-ethyl]alpha-phenyl-3-

(1H-1,2,4-triazole)-1-propanenitrile] and

its metabolites, cis-5-(4-chlorophenyl)-

dihydro-3-phenyl-3-(1H-1,2,4-triazole-1-

ylmethyl)-2-3H-furanone and trans-5-(4-

chlorophenyl)dihydro-3-phenyl-3-(1H

1,2,4-triazole-1-ylmethyl-2-3H-furanone,

expressed as fenbuconazole in or on

blueberries in connection with use of

the pesticide under a section 18

exemption granted by EPA. The timelimited tolerance will expire on the date

specified in the following table.

Commodity Parts per

million

Expiration/

revocation

date

Blueberries ...... 1.0 12/31/99

(c) Tolerances with regional

registrations. [Reserved]

(d) Indirect or inadvertent residues.

[Reserved]

[FR Doc. 98–15173 Filed 6–9–98; 8:45 am]

BILLING CODE 6560–50–F

ENVIRONMENTAL PROTECTION

AGENCY

40 CFR Part 180

[OPP–300657; FRL–5789–8]

RIN 2070–AB78

Clopyralid; Extension of Tolerance for

Emergency Exemptions

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Final rule.

SUMMARY: This rule extends a timelimited tolerance for residues of the

herbicide clopyralid in or on canola at

3 part per million (ppm) for an

additional one and one-half–year

period, to January 31, 2000. This action

is in response to EPA’s granting of an

emergency exemption under section 18

of the Federal Insecticide, Fungicide,

and Rodenticide Act (FIFRA)

authorizing use of the pesticide on

canola. Section 408(l)(6) of the Federal

Food, Drug, and Cosmetic Act (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.

DATES: This regulation becomes

effective June 10, 1998. Objections and

requests for hearings must be received

by EPA, on or before August 10, 1998.

ADDRESSES: Written objections and

hearing requests, identified by the

docket control number, OPP–300657,

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–

300657, 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. 119, Crystal Mall #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. Follow the

instructions in Unit II. of this preamble.

No Confidential Business Information

(CBI) should be submitted through email.

FOR FURTHER INFORMATION CONTACT: By

mail: Libby Pemberton, 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: Rm. 272,

CM #2, 1921 Jefferson Davis Hwy.,

Arlington, VA 22202, (703)–308–9364;

e-mail:

pemberton.libby@epamail.epa.gov.