34304 Federal Register / Vol. 63, No. 121 /Wednesday, June 24, 1998 /Rules and Regulations

EFFECTIVE DATE: This correction is

effective June 24, 1998.

ADDRESSES: Written objections and

hearing requests, identified by the

docket control number, [OPP–300655A],

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–

300655A], 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–

300655A]. 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: Marshall Swindell, Product

Manager 33, Antimicrobials Division

(7510W), Office of Pesticide Programs,

Environmental Protection Agency, 401

M St., SW., Washington, DC 20460.

Office location, telephone number, and

e-mail address: 2800 Crystal Drive, 6th

Floor, Arlington, VA, 22202, 703-308-

6341, e-mail:

swindell.marshall@epamail.epa.gov.

SUPPLEMENTARY INFORMATION:

I. Background

In the Federal Register of May 6, 1998

(63 FR 24955) (FRL–5789–4), EPA,

issued a final rule establishing an

exemption from the requirement of a

tolerance for residues of the

antimicrobial pesticide hydrogen

peroxide up to 120 ppm, in or on raw

agricultural commodities, in processed

commodities, when such residues result

from the use of hydrogen peroxide as an

antimicrobial agent on fruits, tree nuts,

cereal grains, herbs, and spices. The

word ‘‘vegetables’’ was omitted from the

specific tolerance exemption language

which is reproduced in five places of

the final rule. This document corrects

the final rule by inserting the word

‘‘vegetables’’ into each place that

contains the specific tolerance

exemption language.

II. Correction

In FR Doc. 98–12037 published on

May 6, 1998 (63 FR 24955), the word

‘‘vegetables, ’’ should be inserted after

‘‘fruits,’’ in the following places:

1. On page 24956, in the first column,

in the SUMMARY, in the seventh line.

2. On page 24957, in the third

column, the paragraph under II.

Aggregate Risk Assessment and

Determination of Safety, in the fourth

line from the bottom.

3. On page 24960, in the first column,

under C. Exposures and Risks, in the

paragraph numbered 1., in the tenth

line.

4. On page 24962, in the third

column, the first paragraph under IV.

Conclusion, in the eighth line.

III. Regulatory Assessment

Requirements

This final rule does not impose any

requirements. It only implements a

technical correction to the Code of

Federal Regulations (CFR). As such, this

action does not require review by the

Office of Management and Budget

(OMB) under Executive Order 12866,

entitled Regulatory Planning and

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

the Paperwork Reduction Act (PRA), 44

U.S.C. 3501 et seq., or Executive Order

13045, entitled Protection of Children

from Environmental Health Risks and

Safety Risks (62 FR 19885, April 23,

1997). For the same reason, it does not

require any action under Title II of the

Unfunded Mandates Reform Act of 1995

(UMRA) (Pub. L. 104-4), Executive

Order 12875, entitled Enhancing the

Intergovernmental Partnership (58 FR

58093, October 28, 1993), or Executive

Order 12898, entitled Federal Actions to

Address Environmental Justice in

Minority Populations and Low-Income

Populations (59 FR 7629, February 16,

1994). In addition, since this type of

action does not require any proposal, no

action is needed under the Regulatory

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

seq.).

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

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 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: June 10, 1998.

Frank Sanders,

Director, Antimicrobials Division, Office of

Pesticide Programs.

PART 180— [AMENDED]

1. The authority citation for part 180

continues to read as follows:

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

§ 180.1197 [Corrected]

2. On page 24963, in the third

column, § 180.1197 is corrected by

adding ‘‘vegetables,’’ after ‘‘fruits,’’ in

the eighth line.

[FR Doc. 98–16675 Filed 6–23–98; 8:45 am]

BILLING CODE 6560–50–F

ENVIRONMENTAL PROTECTION

AGENCY

40 CFR Part 180

[OPP–300676; FRL–5797–5]

RIN 2070–AB78

Fludioxonil; Pesticide Tolerances for

Emergency Exemptions

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Final rule.

SUMMARY: This regulation establishes

time-limited tolerances for residues of

fludioxonil in or on apricots, nectarines,

peaches and plums. This action is in

response to EPA’s granting of an

emergency exemption under section 18
Federal Register / Vol. 63, No. 121 /Wednesday, June 24, 1998 /Rules and Regulations 34305

of the Federal Insecticide, Fungicide,

and Rodenticide Act authorizing use of

the pesticide on stone fruit in California,

Georgia and South Carolina. This

regulation establishes a maximum

permissible level for residues of

fludioxonil 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 tolerances

will expire and are revoked on

December 31, 1999.

DATES: This regulation is effective June

24, 1998. Objections and requests for

hearings must be received by EPA on or

before August 24, 1998.

ADDRESSES: Written objections and

hearing requests, identified by the

docket control number, [OPP–300676],

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–

300676], 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–

300676]. 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: Stephen Schaible, 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) 308-9362; e-mail:

schaible.stephen@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

tolerances for residues of the fungicide

4-(2,2-difluoro-1,3-benzodioxol-4-yl)-

1H-pyrrole-3-carbonitrile, hereafter

referred to as fludioxonil, in or on

apricots, nectarines, peaches and plums

at 5.0 part per million (ppm). These

tolerances will expire and are revoked

on December 31, 1999. EPA will publish

a document in the Federal Register to

remove the revoked tolerances 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 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

Fludioxonil on Apricots, Nectarines,

Peaches and Plums and FFDCA

Tolerances

The California Department of

Pesticide Regulation, South Carolina

Department of Pesticide Regulation, and

Georgia Department of Agriculture have

requested the use of fludioxonil on

stone fruit to control brown rot, gray

mold rot and Rhizopus rot. These fungal

pathogens cause latent infection during

the period from shuck fall through

harvest. When a fruit matures its disease

resistance declines and a latent fungal

infection turns into a fruit lesion.

Lesioned fruit become unmarketable.

Harvested fruit were treated with the

systemic fungicide iprodione up until

1996, when the manufacturer canceled

postharvest use on stone fruit. During

1997, left over iprodione stock was

used; many packing houses packed the

fruit without a fungicide treatment,

which resulted in significant yield and

quality losses of the produce. The only

other registered alternative, dicloran,

does not control these fruit diseases at

a commercially acceptable level.

Significant economic losses to growers

are expected without the proposed use.

EPA has authorized under FIFRA

section 18 the use of fludioxonil on

stone fruit for control of brown rot, gray

mold rot, and Rhizopus rot in

California, Georgia and South Carolina.
34306 Federal Register / Vol. 63, No. 121 /Wednesday, June 24, 1998 /Rules and Regulations

After having reviewed the submissions,

EPA concurs that emergency conditions

exist for these States.

As part of its assessment of this

emergency exemption, EPA assessed the

potential risks presented by residues of

fludioxonil in or on apricots, nectarines,

peaches and plums. 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 these

tolerances without notice and

opportunity for public comment under

section 408(e), as provided in section

408(l)(6). Although these tolerances will

expire and are revoked on December 31,

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

residues of the pesticide not in excess

of the amounts specified in the

tolerances remaining in or on apricots,

nectarines, peaches and plums 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 these tolerances at the

time of that application. EPA will take

action to revoke these tolerances earlier

if any experience with, scientific data

on, or other relevant information on this

pesticide indicate that the residues are

not safe.

Because these tolerances are being

approved under emergency conditions

EPA has not made any decisions about

whether fludioxonil meets EPA’s

registration requirements for use on

apricots, nectarines, peaches and plums

or whether permanent tolerances for

this use would be appropriate. Under

these circumstances, EPA does not

believe that these tolerances serve as a

basis for registration of fludioxonil by a

State for special local needs under

FIFRA section 24(c). Nor do these

tolerances serve as the basis for any

State other than California, Georgia and

South Carolina 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

fludioxonil, 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

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
Federal Register / Vol. 63, No. 121 /Wednesday, June 24, 1998 /Rules and Regulations 34307

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 yr. 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 fludioxonil and to make a

determination on aggregate exposure,

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

time-limited tolerances for residues of

fludioxonil on apricots, nectarines,

peaches and plums at 5.0 ppm. EPA’s

assessment of the dietary exposures and

risks associated with establishing the

tolerances 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 fludioxonil are

discussed below.

1. Acute toxicity. No endpoint was

identified for acute dietary exposure.

The EPA has concluded that the

toxicology database does not suggest the

need for this assessment, as no acute

effects are expected to result from

exposure to fludioxonil.

2. Chronic toxicity. EPA has

established the RfD for fludioxonil at

0.03 milligrams/kilogram/day (mg/kg/

day). This RfD is based on a NOEL of

3.3 mg/kg/day, taken from a chronic

feeding study in dogs, and an

uncertainty factor of 100. The effect

observed at the LEL of 35.5 mg/kg/day

was decreased body weight gain in

females.

3. Carcinogenicity. Fludioxonil has

been classified as a Group D- not

classifiable as to human carcinogenicitychemical by the Cancer Peer Review

Committee.

B. Exposures and Risks

1. From food and feed uses. A

tolerance has been established (40 CFR

180.516) for the residues of fludioxonil

in or on potatoes at 0.02 ppm.

Fludioxonil is currently registered for

use as a seed treatment on potatoes,

popcorn, field and sweet corn, and

sorghum, as well as for use in

greenhouses on nonfood crops. Since

residues in corn and sorghum are nonquantifiable, these uses do not require

tolerances. Risk assessments were

conducted by EPA to assess dietary

exposures and risks from fludioxonil as

follows:

Chronic exposure and risk. Tolerance

level residues and 100% crop treated

were assumed to calculate TMRCs for

the U.S. population and population

subgroups from residues on potatoes

and stone fruit. Chronic exposure from

food uses of fludioxonil represents 6%

of the RfD for the U.S. population and

52% of the RfD for non-nursing infants

(<1yr), the subgroup most highly

exposed.

2. From drinking water. In light of the

use pattern, a post-harvest spray

treatment for stone fruit which would

occur indoors, along with the currently

registered uses- seed treatments for

potato and corn (field & sweet),

popcorn, and sorghum, and ornamental

plants grown in greenhouses, or other

enclosed structures- fludioxonil is not

expected to impact ground or surface

waters. As a result, the likelihood of

residues of fludioxonil in drinking

water is negligible. Therefore, EPA

concludes that a drinking water risk

assessment is not required at this time.

Therefore, there is no drinking water

risk assessment to aggregate with the

chronic dietary (food sources) risk

assessment.

3. From non-dietary exposure.

Fludioxonil is currently not registered

for use on residential, non-food sites;

therefore, no non-occupational, nondietary exposure is expected. (Please

remove all language in this section from

this point on).

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
34308 Federal Register / Vol. 63, No. 121 /Wednesday, June 24, 1998 /Rules and Regulations

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

fludioxonil 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,

fludioxonil 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 fludioxonil has a common

mechanism of toxicity with other

substances.

C. Aggregate Risks and Determination of

Safety for U.S. Population

Chronic risk. Using the TMRC

exposure assumptions described above,

EPA has concluded that aggregate

exposure to fludioxonil from food will

utilize 6% of the RfD for the U.S.

population. The major identifiable

subgroup with the highest aggregate

exposure is non-nursing infants (<1 yr)

(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.

Given that the proposed use pattern is

a postharvest spray treatment for stone

fruit which would occur indoors, and

that currently registered uses are for

seed treatments at a low application rate

and for ornamental plants grown in

greenhouses or other enclosed

structures, fludioxonil is not expected to

impact ground or surface water; the

likelihood of residues in drinking water

is negligible. Currently, there are no

registered residential uses of

fludioxonil. EPA concludes that there is

a reasonable certainty that no harm will

result from aggregate exposure to

fludioxonil residues.

D. 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

fludioxonil, EPA considered data from

developmental toxicity studies in the rat

and rabbit and a two-generation

reproduction study in the rat. The

developmental toxicity studies are

designed to evaluate adverse effects on

the developing organism resulting from

maternal pesticide exposure during

gestation. Reproduction studies provide

information relating to effects from

exposure to the pesticide on the

reproductive capability of mating

animals and data on systemic toxicity.

FFDCA section 408 provides that EPA

shall apply an additional tenfold margin

of safety for infants and children in the

case of threshold effects to account for

pre-and post-natal toxicity and the

completeness of the database unless

EPA determines that a different margin

of safety will be safe for infants and

children. Margins of safety are

incorporated into EPA risk assessments

either directly through use of a MOE

analysis or through using uncertainty

(safety) factors in calculating a dose

level that poses no appreciable risk to

humans. EPA believes that reliable data

support using the standard 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 rat developmental study, the

maternal (systemic) NOEL was 100 mg/

kg/day, based on reduction in mean

body weight gain in dams during

gestation period at the lowest-observedeffect-level (LOEL) of 1,000 mg/kg/day.

The developmental (fetal) NOEL was

100 mg/kg/day, based on increased fetal

and litter incidence of dilated renal

pelvis and dilated ureter at the LOEL of

1,000 mg/kg/day. In the rabbit

developmental toxicity study, the

maternal (systemic) NOEL was 10 mg/

kg/day, based on decreased body weight

gains and food efficiency at the LOEL of

100 mg/kg/day. The developmental

(pup) NOEL was 300 mg/kg/day, the

highest dose tested.

iii. Reproductive toxicity study. In the

two-generation reproductive toxicity

study in rats, the parental (systemic)

NOEL was 22.13 mg/kg/day (males) and

24.24 mg/kg/day (females), based on

clinical signs and decreased body

weight, body weight gain and food

consumption at the LOEL of 221.6 mg/

kg/day (males) and 249.7 mg/kg/day

(females). The reproductive/

developmental (pup) NOEL was 22.13

mg/kg/day (males) and 24.24 mg/kg/day

(females), based on reduced pup

weights at the LOEL of 221.6 mg/kg/day

(males) and 249.7 mg/kg/day (females).

iv. Pre- and post-natal sensitivity. The

toxicological data base for evaluating

pre- and post-natal toxicity for

fludioxonil is complete with respect to

current data requirements. There are no

pre- or post-natal toxicity concerns for

infants and children, based on the

results of the rat and rabbit

developmental toxicity studies and the

two-generation rat reproductive toxicity

study.

v. Conclusion. EPA concludes that

reliable data support the removal of the

additional uncertainty factor; the

standard hundredfold uncertainty factor

is adequate to protect the safety of

infants and children.

2. Chronic risk. Using the

conservative exposure assumptions

described above, EPA has concluded

that aggregate exposure to fludioxonil
Federal Register / Vol. 63, No. 121 /Wednesday, June 24, 1998 /Rules and Regulations 34309

from food will utilize 52% of the RfD for

infants and children. 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. Exposure from

drinking water and residential uses is

not expected. EPA concludes that there

is a reasonable certainty that no harm

will result to infants and children from

aggregate exposure to fludioxonil

residues.

V. Other Considerations

A. Metabolism In Plants and Animals

The nature of the residue in stone

fruit is adequately understood based on

a metabolism study submitted for seed

treatment use on potatoes. The residue

of concern is the parent compound,

fludioxonil, only. There are no livestock

feed items associated with the proposed

use on stone fruit. Therefore, the nature

of the residue in animals is not germane

to these section 18 requests or to the

establishment of these tolerances.

B. Analytical Enforcement Methodology

Adequate enforcement methodology

(GC/NPD) was provided with the

Applicants’ submissions to enforce the

tolerance expression (modifications to

Methods AG-597B and AG-664).

C. Magnitude of Residues

Residues of fludioxonil are not

expected to exceed 5.0 ppm in/on

apricots, nectarines, peaches, and plums

as a result of the proposed section 18

use. Secondary residues are not

expected in animal commodities as

there are no feed items associated with

this section 18 use.

D. International Residue Limits

No CODEX, Canadian, or Mexican

MRLs/tolerances have been established

for residues of fludioxonil on stone

fruit.

E. Rotational Crop Restrictions

The proposed post-harvest use does

not involve application of fludioxonil to

fields of growing crops. Therefore,

rotational crop restrictions are not

relevant to this discussion.

VI. Conclusion

Therefore, tolerances are established

for residues of fludioxonil in apricots,

nectarines, peaches and plums at 5.0

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 24, 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–300676] (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 tolerances

under FFDCA section 408(l)(6) 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

consultation as specified by Executive

Order 12875, entitled Enhancing the

Intergovernmental Partnership (58 FR
34310 Federal Register / Vol. 63, No. 121 /Wednesday, June 24, 1998 /Rules and Regulations

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

tolerances 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

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

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 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: June 8, 1998.

Peter Caulkins,

Acting Director, Registration Division, Office

of Pesticide Programs.

Therefore, 40 CFR chapter I is

amended as follows:

PART 180— [AMENDED]

1. The authority citation for part 180

continues to read as follows:

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

2. In § 180.516, by adding text to

paragraph (b) to read as follows:

§ 180.516 Fludioxonil; tolerances for

residues.

* * * * *

(b) Section 18 emergency exemptions.

Time-limited tolerances are established

for residues of the fungicide fludioxonil

(4-(2,2-difluoro-1,3-benzodioxol-4-yl)-

1H-pyrrole-3-carbonitrile) 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

Apricots ................................................................................................ 5.0 12/31/99

Nectarines ............................................................................................ 5.0 12/31/99

Peaches ............................................................................................... 5.0 12/31/99

Plums ................................................................................................... 5.0 12/31/99

* * * * *

[FR Doc. 98–16677 Filed 6–23–98; 8:45 am]

BILLING CODE 6560–50–F

ENVIRONMENTAL PROTECTION

AGENCY

40 CFR Part 180

[OPP–300675; FRL 5796–9]

RIN 2070–AB78

Tebufenozide; Benzoic Acid, 3,5-

dimethyl-1-(1,1-dimethylethyl)-2-(4-

ethylbenzoyl) hydrazide

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Final rule.

SUMMARY: This regulation establishes

tolerances for residues of tebufenozide

in or on pecans and grapes, wine and a

time-limited tolerance for residues of

tebufenozide in or on pears. The timelimited tolerance for pears is being

established to allow the use of

tebufenozide on pears under an

Experimental Use Permit. Rohm and

Haas Company requested these

tolerances under the Federal Food,

Drug, and Cosmetic Act (FFDCA), as

amended by the Food Quality Protection

Act of 1996 (Pub. L. 104–170).

DATES: This regulation is effective June

24, 1998. Objections and requests for

hearings must be received by EPA on or

before August 24, 1998.

ADDRESSES: Written objections and

hearing requests, identified by the

docket control number, [OPP–300675],

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–

300675], 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–

300675]. No Confidential Business

Information (CBI) should be submitted

through e-mail. Electronic copies of

objections and hearing requests on this