41286 Federal Register / Vol. 62, No. 148 / Friday, August 1, 1997 / Rules and Regulations

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.

VI. 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: July 24, 1997.

Stephen L. Johnson,

Acting Director, 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.

§ 180.1001 [Amended]

2. In § 180.1001, Exemptions from the

requirement of a tolerance, by adding

and alphabetically inserting copper

octanoate in paragraph (b)(1).

[FR Doc. 97–20361 Filed 7-31-97; 8:45 am]

BILLING CODE 6560–50–F

ENVIRONMENTAL PROTECTION

AGENCY

40 CFR Part 180

[OPP–300520; FRL–5732–5]

RIN 2070–AB78

Fludioxonil; Pesticide Tolerances for

Emergency Exemptions

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Final rule.

SUMMARY: This regulation establishes a

time-limited tolerance for residues of

fludioxonil in or on potatoes . This

action is in response to EPA’s granting

of an emergency exemption under

section 18 of the Federal Insecticide,

Fungicide, and Rodenticide Act

authorizing use of the pesticide on

potatoes. 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 tolerance

will expire and is revoked on August 1,

1998.

DATES: This regulation is effective

August 1, 1997. Objections and requests

for hearings must be received by EPA on

or before September 30, 1997.

ADDRESSES: Written objections and

hearing requests, identified by the

docket control number, [OPP–300520],

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–

300520], must also be submitted to:

Public Information and Records

Integrity Branch, Information Resources

and Services Division (7506C), Office of

Pesticide Programs, Environmental

Protection Agency, 401 M St., SW.,

Washington, DC 20460. In person, bring

a copy of objections and hearing

requests to Rm. 1132, CM #2, 1921

Jefferson Davis Hwy., Arlington, VA.

A copy of objections and hearing

requests filed with the Hearing Clerk

may also be submitted electronically by

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

objections and hearing requests must be

submitted as an ASCII file avoiding the

use of special characters and any form

of encryption. Copies of objections and

hearing requests will also be accepted

on disks in WordPerfect 5.1 file format

or ASCII file format. All copies of

objections and hearing requests in

electronic form must be identified by

the docket control number [OPP–

300520]. 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: Andrew Ertman, 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) 308-9367, e-mail:

ertman.andrew@epamail.epa.gov.

SUPPLEMENTARY INFORMATION: EPA, on

its own initiative, pursuant to section

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

Drug, and Cosmetic Act (FFDCA), 21

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

a tolerance for residues of the fungicide

fludioxonil, in or on potatoes at 0.02

part per million (ppm). This tolerance

will expire and is revoked on August 1,

1998. EPA will publish a document in

the Federal Register to remove the

revoked tolerance from the Code of

Federal Regulations.

I. Background and Statutory Authority

The Food Quality Protection Act of

1996 (FQPA) (Pub. L. 104–170) was

signed into law August 3, 1996. FQPA

amends both the Federal Food, Drug,

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

301 et seq., and the Federal Insecticide,

Fungicide, and Rodenticide Act

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

amendments went into effect

immediately. Among other things,

FQPA amends FFDCA to bring all EPA

pesticide tolerance-setting activities

under a new section 408 with a new

safety standard and new procedures.

These activities are described below and

discussed in greater detail in the final

rule establishing the time-limited

tolerance associated with the emergency

exemption for use of propiconazole on

sorghum (61 FR 58135, November 13,

1996)(FRL-5572-9).

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

FFDCA allows EPA to establish a

tolerance (the legal limit for a pesticide

chemical residue in or on a food) only

if EPA determines that the tolerance is

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

‘‘safe’’ to mean that ‘‘there is a

reasonable certainty that no harm will

result from aggregate exposure to the

pesticide chemical residue, including

all anticipated dietary exposures and all

other exposures for which there is

reliable information.’’ This includes

exposure through drinking water and in

residential settings, but does not include

occupational exposure. Section

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

consideration to exposure of infants and

children to the pesticide chemical

residue in establishing a tolerance and
Federal Register / Vol. 62, No. 148 / Friday, August 1, 1997 / Rules and Regulations 41287

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 Potatoes and FFDCA

Tolerances

North Dakota, Nebraska, Washington,

and Minnesota have all requested

exemptions for the use of fludioxonil on

potatoes to control silver scurf. The

applicants state that silver scurf has

become a major problem in the past few

years in part due to its resistance to

thiabendazole (TBZ), a fungicide that is

used as a treatment for potatoes going

into storage for control of Fusarium dry

rot. Although not registered for control

of silver scurf, TBZ had the secondary

benefit of helping to prevent the

development of symptoms and spread of

silver scurf in storage.

With the emergence of TBZ resistant

silver scurf, the potato crop has been

affected by reduced market quality and

increased weight loss of potatoes during

storage. The applicants claim that there

is no registered product alone which

prevents spread of silver scurf from

infected seed pieces to the developing

tubers and that economic losses will

occur without the use of fludioxonil.

EPA has authorized under FIFRA

section 18 the use of fludioxonil on

potatoes for control of silver scurf in

North Dakota, Nebraska, Washington,

and Minnesota. After having reviewed

the submission, 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 potatoes. In doing

so, EPA considered the new safety

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

and EPA decided that the necessary

tolerance under FFDCA section 408(l)(6)

would be consistent with the new safety

standard and with FIFRA section 18.

Consistent with the need to move

quickly on the emergency exemption in

order to address an urgent non-routine

situation and to ensure that the resulting

food is safe and lawful, EPA is issuing

this tolerance without notice and

opportunity for public comment under

section 408(e), as provided in section

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

expire and is revoked on August 1,

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

residues of the pesticide not in excess

of the amounts specified in the

tolerance remaining in or on potatoes

after that date will not be unlawful,

provided the pesticide is applied in a

manner that was lawful under FIFRA.

EPA will take action to revoke this

tolerance earlier if any experience with,

scientific data on, or other relevant

information on this pesticide indicate

that the residues are not safe.

Because this tolerance is being

approved under emergency conditions

EPA has not made any decisions about

whether fludioxonil meets EPA’s

registration requirements for use on

potatoes 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

fludioxonil 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 North Dakota,

Nebraska, Washington, and Minnesota

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
41288 Federal Register / Vol. 62, No. 148 / Friday, August 1, 1997 / Rules and Regulations

carcinogen, different types of risk

assessments (e.g., linear low dose

extrapolations or MOE calculation based

on the appropriate NOEL) will be

carried out based on the nature of the

carcinogenic response and the Agency’s

knowledge of its mode of action.

2. Differences in toxic effect due to

exposure duration. The toxicological

effects of a pesticide can vary with

different exposure durations. EPA

considers the entire toxicity data base,

and based on the effects seen for

different durations and routes of

exposure, determines which risk

assessments should be done to assure

that the public is adequately protected

from any pesticide exposure scenario.

Both short and long durations of

exposure are always considered.

Typically, risk assessments include

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

term’’, and ‘‘chronic’’ risks. These

assessments are defined by the Agency

as follows.

Acute risk, by the Agency’s definition,

results from 1-day consumption of food

and water, and reflects toxicity which

could be expressed following a single

oral exposure to the pesticide residues.

High end exposure to food and water

residues are typically assumed.

Short-term risk results from exposure

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

and therefore overlaps with the acute

risk assessment. Historically, this risk

assessment was intended to address

primarily dermal and inhalation

exposure which could result, for

example, from residential pesticide

applications. However, since enaction of

FQPA, this assessment has been

expanded to include both dietary and

non-dietary sources of exposure, and

will typically consider exposure from

food, water, and residential uses when

reliable data are available. In this

assessment, risks from average food and

water exposure, and high-end

residential exposure, are aggregated.

High-end exposures from all 3 sources

are not typically added because of the

very low probability of this occurring in

most cases, and because the other

conservative assumptions built into the

assessment assure adequate protection

of public health. However, for cases in

which high-end exposure can

reasonably be expected from multiple

sources (e.g. frequent and widespread

homeowner use in a specific

geographical area), multiple high-end

risks will be aggregated and presented

as part of the comprehensive risk

assessment/characterization. Since the

toxicological endpoint considered in

this assessment reflects exposure over a

period of at least 7 days, an additional

degree of conservatism is built into the

assessment; i.e., the risk assessment

nominally covers 1-7 days exposure,

and the toxicological endpoint/NOEL is

selected to be adequate for at least 7

days of exposure. (Toxicity results at

lower levels when the dosing duration

is increased.)

Intermediate-term risk results from

exposure for 7 days to several months.

This assessment is handled in a manner

similar to the short-term risk

assessment.

Chronic risk assessment describes risk

which could result from several months

to a lifetime of exposure. For this

assessment, risks are aggregated

considering average exposure from all

sources for representative population

subgroups including infants and

children.

B. Aggregate Exposure

In examining aggregate exposure,

FFDCA section 408 requires that EPA

take into account available and reliable

information concerning exposure from

the pesticide residue in the food in

question, residues in other foods for

which there are tolerances, residues in

groundwater or surface water that is

consumed as drinking water, and other

non-occupational exposures through

pesticide use in gardens, lawns, or

buildings (residential and other indoor

uses). Dietary exposure to residues of a

pesticide in a food commodity are

estimated by multiplying the average

daily consumption of the food forms of

that commodity by the tolerance level or

the anticipated pesticide residue level.

The Theoretical Maximum Residue

Contribution (TMRC) is an estimate of

the level of residues consumed daily if

each food item contained pesticide

residues equal to the tolerance. In

evaluating food exposures, EPA takes

into account varying consumption

patterns of major identifiable subgroups

of consumers, including infants and

children. The TMRC is a ‘‘worst case’’

estimate since it is based on the

assumptions that food contains

pesticide residues at the tolerance level

and that 100% of the crop is treated by

pesticides that have established

tolerances. If the TMRC exceeds the RfD

or poses a lifetime cancer risk that is

greater than approximately one in a

million, EPA attempts to derive a more

accurate exposure estimate for the

pesticide by evaluating additional types

of information (anticipated residue data

and/or percent of crop treated data)

which show, generally, that pesticide

residues in most foods when they are

eaten are well below established

tolerances.

Percent of crop treated estimates are

derived from federal and private market

survey data. Typically, a range of

estimates are supplied and the upper

end of this range is assumed for the

exposure assessment. By using this

upper end estimate of percent of crop

treated, the Agency is reasonably certain

that exposure is not understated for any

significant subpopulation group.

Further, regional consumption

information is taken into account

through EPA’s computer-based model

for evaluating the exposure of

significant subpopulations including

several regional groups, to pesticide

residues. For this pesticide, the most

highly exposed population subgroup

(children (1-6 years old) was not

regionally based.

IV. Aggregate Risk Assessment and

Determination of Safety

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

EPA has reviewed the available

scientific data and other relevant

information in support of this action,

EPA has sufficient data to assess the

hazards of fludioxonil and to make a

determination on aggregate exposure,

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

time-limited tolerance for residues of

fludioxonil on potatoes at 0.02 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 fludioxonil are

discussed below.

1. Acute toxicity. The Agency did not

identify an acute dietary toxicological

endpoint, therefore, this risk assessment

was not conducted.

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 from a 1-year dog feeding

study, and by using an uncertainty

factor of 100. The NOEL was based on

decreased body weight gain at the

lowest effect level (LEL) of 35.5 mg/kg/

day.

3. Carcinogenicity. Fludioxonil has

been classified as a Group D chemical,

inconclusive evidence of human

carcinogenicity, by the Agency.
Federal Register / Vol. 62, No. 148 / Friday, August 1, 1997 / Rules and Regulations 41289

B. Exposures and Risks

1. From food and feed uses.

Tolerances have not been established for

fludioxonil. However, fludioxonil is

currently registered as a food use not

requiring a tolerance for use as a seed

treatment on corn and sorghum as well

as a greenhouse use. Risk assessments

were conducted by EPA to assess

dietary exposures and risks from

fludioxonil 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. Since an

acute dietary endpoint has not been

identified in the toxicology database, an

assessment of acute dietary risk was not

conducted for this Section 18 request.

ii. Chronic exposure and risk. The

chronic dietary (food only) risk

assessment assumed tolerance level

residues and 100% crop treated for

potatoes which is the only commodity

having established or proposed

fludioxonil tolerances. Therefore, the

resulting exposure estimates should be

viewed as conservative; further

refinement using anticipated residues

and/or percent of crop-treated would

result in lower dietary exposure

estimates. Fludioxonil is currently

registered for use as a seed treatment on

corn and sorghum as well as a

greenhouse use. No DRES run was

conducted for the corn or sorghum use

because these uses were classified as

uses not requiring tolerances since the

residues are non-quantifiable.

This fludioxonil tolerance, necessary

for this Section 18, results in a

Theoretical Maximum Residue

Contribution (TMRC) that is equivalent

to the following percentages of the RfD:

Population SubgroupTMRCfood

(mg/kg/day) %RfD

U.S. population - 48

States.

0.000023 <1%

Nursing infants (<1

year old).

0.000007 <1%

Non-nursing infants

(<1 year old).

0.000028 <1%

Children (1-6 years

old).

0.000045 <1%

Children (7-12 years

old).

0.000034 <1%

The subgroups listed above are: (1)

the U.S. population (48 States); and, (2)

those for infants and children.

For chronic dietary risk to

fludioxonil, all population subgroups

have < 1% of the RfD occupied.

2. From drinking water. There is no

established Maximum Contaminant

Level (MCL) for residues of fludioxonil

in drinking water. No drinking water

Health Advisories have been issued for

fludioxonil. There is no entry for

fludioxonil in the ‘‘Pesticides in

Groundwater Database’’ (EPA 734–12–

92–001, September 1992).

Chronic exposure and risk. Because

the Agency lacks sufficient waterrelated exposure data to complete a

comprehensive drinking water risk

assessment for many pesticides, EPA

has commenced and nearly completed a

process to identify a reasonable yet

conservative bounding figure for the

potential contribution of water-related

exposure to the aggregate risk posed by

a pesticide. In developing the bounding

figure, EPA estimated residue levels in

water for a number of specific pesticides

using various data sources. The Agency

then applied the estimated residue

levels, in conjunction with appropriate

toxicological endpoints (RfD’s or acute

dietary NOEL’s) and assumptions about

body weight and consumption, to

calculate, for each pesticide, the

increment of aggregate risk contributed

by consumption of contaminated water.

While EPA has not yet pinpointed the

appropriate bounding figure for

exposure from contaminated water, the

ranges the Agency is continuing to

examine are all below the level that

would cause fludioxonil to exceed the

RfD if the tolerance being considered in

this document were granted. The

Agency has therefore concluded that the

potential exposures associated with

fludioxonil in water, even at the higher

levels the Agency is considering as a

conservative upper bound, would not

prevent the Agency from determining

that there is a reasonable certainty of no

harm if the tolerance is granted.

3. From non-dietary exposure.

Fludioxonil is is not currently registered

for any indoor or outdoor residential

uses; therefore, no non-dietary, nonoccupational exposure is anticipated.

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

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

1. Acute risk. Since no acute endpoint

was identified for fludioxonil, no acute

risk assessment was conducted.
41290 Federal Register / Vol. 62, No. 148 / Friday, August 1, 1997 / Rules and Regulations

2. Chronic risk. Using the

conservative exposure assumptions

described above, and taking into

account the completeness and reliability

of the toxicity data, the Agency has

concluded that dietary (food only)

exposure to fludioxonil will utilize <1%

of the RfD for the U.S. population. EPA

generally has no concern for exposures

below 100% of the RfD because the RfD

represents the level at or below which

daily aggregate dietary exposure over a

lifetime will not pose appreciable risks

to human health. Despite the potential

for exposure to fludioxonil in drinking

water, EPA does not expect the

aggregate exposure (food and water) to

exceed 100% of the RfD. Since there are

no non-dietary non-occupational

exposure scenarios for fludioxonil, there

is no additional exposure from those

routes. EPA concludes that there is a

reasonable certainty that no harm will

result from aggregate chronic exposure

to fludioxonil residues.

3. Short- and intermediate-term risk.

Short- and intermediate-term aggregate

exposure takes into account chronic

dietary food and water (considered to be

a background exposure level) plus

indoor and outdoor residential

exposure.

Since there are no indoor/outdoor

residential uses for fludioxonil, no

short- or intermediate-term risk

assessment is required.

D. Aggregate Cancer Risk for U.S.

Population

Since fludioxonil has been classified

as a Group D chemical, inconclusive

evidence of human carcinogenicity, no

cancer risk assessment is required.

E. Aggregate Risks and Determination of

Safety for Infants and Children

1. Safety factor for infants and

children— a. 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

pesticide exposure during prenatal

development to one or both parents.

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.

b. Developmental toxicity studies.

From the developmental toxicity study

in rats, the maternal (systemic) NOEL

was 100 mg/kg/day, based on decreased

weight gain at the lowest observed effect

level (LOEL) of 1,000 mg/kg/day. The

developmental (fetal) NOEL was 100

mg/kg/day, based on dilated renal pelvis

and dilated ureter at the LOEL of 1,000

mg/kg/day.

From the developmental study in

rabbits, the maternal (systemic) NOEL

was 100 mg/kg/day, based on decreased

weight gain and food efficiency at the

LOEL of 100 mg/kg/day. The

developmental (fetal) NOEL was 300

mg/kg/day (highest dose tested).

c. Reproductive toxicity study. From

the reproductive toxicity study in rats,

the maternal (systemic) NOEL was 22.1

mg/kg/day, based on decreased weight

gains and food consumption at the

LOEL of 221.6 mg/kg/day. The

reproductive/developmental (pup)

NOEL was 22.1 mg/kg/day, based on

decreased pup body weights at the LEL

of 221.6 mg/kg/day.

d. Pre- and post-natal sensitivity. The

pre- and post-natal toxicology data base

for fludioxonil is complete with respect

to current toxicological data

requirements. There are no indications

in the rat and rabbit developmental

studies of any pre-natal extra sensitivity

for infants and children to the effects of

fludioxonil.

There is no need for any extra postnatal sensitivity factor based on the

results of the reproductive toxicity

study, since both the effects in pups and

adult animals are similar (decreased

body weight) and the dose levels for

pup and adult NOELs and LOELs,

respectively, are the same.

2. Acute risk. Since no acute endpoint

was identified for fludioxonil, no acute

risk assessment is required.

3. Chronic risk. Using the

conservative exposure assumptions

described above, EPA has concluded

that aggregate exposure to fludioxonil

from food will utilize <1% 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. Despite the potential

for exposure to fludioxonil in drinking

water and from non-dietary, nonoccupational exposure, EPA does not

expect the aggregate exposure to exceed

100% of the RfD. EPA concludes that

there is a reasonable certainty that no

harm will result to infants and children

from aggregate exposure to fludioxonil

residues.

V. Other Considerations

A. Metabolism In Plants and Animals

The nature of the residue in plants

from this seed use is adequately

understood. The residue of concern is

fludioxonil per se .

B. Analytical Enforcement Methodology

Adequate enforcement methodology

(HPLC/UV) is available as Ciba-Geigy

Method AG-597B to enforce the

tolerance expression.

C. Magnitude of Residues

Residues of fludioxonil are not

expected to exceed 0.02 ppm, or two

times the validated LOQ, for fludioxonil

on potatoes as a result of this Section 18

use.

The Agency has previously concluded

that residues of fludioxonil are not

reasonably expected to accumulate in

ruminant milk and tissues as a result of

this proposed use on potato seed pieces.

In addition, the Section 18 label

prohibits the use of treated seed pieces

as food, feed, or fodder. Therefore,

ruminant commodity tolerances need

not be established in support of the

proposed potato seed piece treatment. If

additional uses of fludioxonil which

may result in animal exposure are

requested in the future, such tolerances

may be necessary.

Secondary residues are not expected

in swine or poultry commodities as no

feed items are associated with this

Section 18 use.

D. International Residue Limits

There are currently no CODEX,

Canadian, or Mexican listings for

fludioxonil residues, therefore there are

no harmonization issues for this action.
Federal Register / Vol. 62, No. 148 / Friday, August 1, 1997 / Rules and Regulations 41291

E. Rotational Crop Restrictions

The Section 18 label specifies that the

rotation of any crop other than potatoes,

corn, sorghum, leafy vegetables, or root

and tuber vegetables within one year of

application is prohibited.

VI. Conclusion

Therefore, the tolerance is established

for residues of fludioxonil in or on

potatoes at 0.02 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 September 30,

1997, file written objections to any

aspect of this regulation and may also

request a hearing on those objections.

Objections and hearing requests must be

filed with the Hearing Clerk, at the

address given above (40 CFR 178.20). A

copy of the objections and/or hearing

requests filed with the Hearing Clerk

should be submitted to the OPP docket

for this rulemaking. The objections

submitted must specify the provisions

of the regulation deemed objectionable

and the grounds for the objections (40

CFR 178.25). Each objection must be

accompanied by the fee prescribed by

40 CFR 180.33(i). If a hearing is

requested, the objections must include a

statement of the factual issues on which

a hearing is requested, the requestor’s

contentions on such issues, and a

summary of any evidence relied upon

by the requestor (40 CFR 178.27). A

request for a hearing will be granted if

the Administrator determines that the

material submitted shows the following:

There is genuine and substantial issue

of fact; there is a reasonable possibility

that available evidence identified by the

requestor would, if established, resolve

one or more of such issues in favor of

the requestor, taking into account

uncontested claims or facts to the

contrary; and resolution of the factual

issues in the manner sought by the

requestor would be adequate to justify

the action requested (40 CFR 178.32).

Information submitted in connection

with an objection or hearing request

may be claimed confidential by marking

any part or all of that information as

Confidential Business Information (CBI).

Information so marked will not be

disclosed except in accordance with

procedures set forth in 40 CFR part 2.

A copy of the information that does not

contain CBI must be submitted for

inclusion in the public record.

Information not marked confidential

may be disclosed publicly by EPA

without prior notice.

VIII. Public Docket

EPA has established a record for this

rulemaking under docket control

number [OPP–300520] (including any

comments and data submitted

electronically). A public version of this

record, including printed, paper

versions of electronic comments, which

does not include any information

claimed as CBI, is available for

inspection from 8:30 a.m. to 4 p.m.,

Monday through Friday, excluding legal

holidays. The public record is located in

Room 1132 of the Public Information

and Records Integrity Branch,

Information Resources and Services

Division (7506C), Office of Pesticide

Programs, Environmental Protection

Agency, Crystal Mall #2, 1921 Jefferson

Davis Hwy., Arlington, VA.

Electronic comments may be sent

directly to EPA at:

opp-docket@epamail.epa.gov.

Electronic comments must be

submitted as an ASCII file avoiding the

use of special characters and any form

of encryption.

The official record for this

rulemaking, as well as the public

version, as described above will be kept

in paper form. Accordingly, EPA will

transfer any copies of objections and

hearing requests received electronically

into printed, paper form as they are

received and will place the paper copies

in the official rulemaking record which

will also include all comments

submitted directly in writing. The

official rulemaking record is the paper

record maintained at the Virginia

address in ‘‘ADDRESSES’’ at the

beginning of this document.

IX. Regulatory Assessment

Requirements

This final rule establishes a tolerance

under FFDCA section 408(d). The Office

of Management and Budget (OMB) has

exempted these types of actions from

review under Executive Order 12866,

entitled Regulatory Planning and

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

This final rule does not contain any

information collections subject to OMB

approval under the Paperwork

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

seq., or impose any enforceable duty or

contain any unfunded mandate as

described under Title II of the Unfunded

Mandates Reform Act of 1995 (UMRA)

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

prior consultation as specified by

Executive Order 12875, entitled

Enhancing the Intergovernmental

Partnership (58 FR 58093, October 28,

1993), or special considerations as

required by Executive Order 12898,

entitled Federal Actions to Address

Environmental Justice in Minority

Populations and Low-Income

Populations (59 FR 7629, February 16,

1994), or require OMB review in

accordance with Executive Order 13045,

entitled Protection of Children from

Environmental Health Risks and Safety

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

In addition, since these tolerances and

exemptions that are established under

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

tolerance in this final rule, do not

require the issuance of a proposed rule,

the requirements of the Regulatory

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

seq.) do not apply. Nevertheless, the

Agency has previously assessed whether

establishing tolerances, exemptions

from tolerances, raising tolerance levels

or expanding exemptions might

adversely impact small entities and

concluded, as a generic matter, that

there is no adverse economic impact.

The factual basis for the Agency’s

generic certification for tolerance

actions published on May 4, 1981 (46

FR 24950), and was provided to the

Chief Counsel for Advocacy of the Small

Business Administration.

X. Submission to Congress and the

General Accounting Office

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

by the Small Business Regulatory

Enforcement Fairness Act of 1996, the

Agency has submitted a report

containing this rule and other required

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

House of Representatives, and the

Comptroller General of the General

Accounting Office prior to publication

of this rule in today’s Federal Register.

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

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

List of Subjects in 40 CFR Part 180

Environmental protection,

Administrative practice and procedure,

Agricultural commodities, Pesticides

and pests, Reporting and recordkeeping

requirements.
41292 Federal Register / Vol. 62, No. 148 / Friday, August 1, 1997 / Rules and Regulations

Dated: July 22, 1997.

James Jones,

Acting Director, Registration Division, Office

of Pesticide Programs.

Therefore, 40 CFR chapter I is

amended as follows:

PART 180—[AMENDED]

1. The authority citation for part 180

continues to read as follows:

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

2. By adding § 180.512 to read as

follows:

§ 180.512. Fludioxonil; tolerances for

residues.

(a) General .[Reserved]

(b) Section 18 emergency exemptions.

A time-limited tolerance is established

fo residues pf the fungicide fludioxonil

in connection with use of the pesticide

under section 18 emergency exemptions

grangted by EPA.The tolerance will

expire and is revoked on the date

specified in the following table.

Commodity Parts per million Expiration/Revocation Date

Potatoes ............................................................................................... 0.02 August 1, 1998

(c) Tolerances with regional

registrations. [Reserved]

(d) Indirect or inadvertent residues.

[Reserved]

[FR Doc. 97–20360 Filed 7-31-97; 8:45 am]

BILLING CODE 6560–50–F

ENVIRONMENTAL PROTECTION

AGENCY

40 CFR Part 300

[FRL–5866–8]

National Oil and Hazardous

Substances Contingency Plan;

National Priorities List Update

AGENCY: Environmental Protection

Agency.

ACTION: Notice of Deletion of the Agate

Lake Scrap Yard Superfund Site from

the National Priorities List (NPL).

SUMMARY: The Environmental Protection

Agency (EPA) announces the deletion of

the Agate Lake Scrap Yard Superfund

Site in Minnesota from the National

Priorities List (NPL). The NPL is

Appendix B of 40 CFR part 300 which

is the National Oil and Hazardous

Substances Contingency Plan (NCP),

which EPA promulgated pursuant to

section 105 of the Comprehensive

Environmental Response,

Compensation, and Liability Act of 1980

(CERCLA), as amended. This action is

being taken by EPA and the State of

Minnesota, because it has been

determined that Responsible Parties

have implemented all appropriate

response actions required. Moreover,

EPA and the State of Minnesota have

determined that remedial actions

conducted at the site to date remain

protective of public health, welfare, and

the environment.

EFFECTIVE DATE: August 1, 1997.

FOR FURTHER INFORMATION CONTACT:

Gladys Beard at (312) 886–7253,

Associate Remedial Project Manager,

Superfund Division, U.S. EPA—Region

V, 77 West Jackson Blvd., Chicago, IL

60604. Information on the site is

available at the local information

repository located at: Brainerd Public

Library, 416 South 5th South Street,

Brainerd, MN 56401. Requests for

comprehensive copies of documents

should be directed formally to the

Regional Docket Office. The contact for

the Regional Docket Office is Jan

Pfundheller (H-7J), U.S. EPA, Region V,

77 W. Jackson Blvd., Chicago, IL 60604,

(312) 353–5821.

SUPPLEMENTARY INFORMATION: The site to

be deleted from the NPL is: Agate Lake

Scrap Yard Superfund Site located in

Fairview Township, Cass County,

Minnesota. A Notice of Intent to Delete

for this site was published June 23, 1997

(62 FR 33789). The closing date for

comments on the Notice of Intent to

Delete was July 22, 1997. EPA received

no comments and therefore no

Responsiveness Summary was prepared. The EPA identifies sites which appear

to present a significant risk to public

health, welfare, or the environment and

it maintains the NPL as the list of those

sites. Sites on the NPL may be the

subject of Hazardous Substance

Response Trust Fund (Fund-) financed

remedial actions. Any site deleted from

the NPL remains eligible for Fundfinanced remedial actions in the

unlikely event that conditions at the site

warrant such action. Section

300.425(e)(3) of the NCP states that

Fund-financed actions may be taken at

sites deleted from the NPL in the

unlikely event that conditions at the site

warrant such action. Deletion of a site

from the NPL does not affect responsible

party liability or impede agency efforts

to recover costs associated with

response efforts.

List of Subjects in 40 CFR Part 300

Environmental protection, Air

pollution control, Chemicals, Hazardous

substances, Hazardous waste,

Intergovernmental relations, Penalties,

Reporting and recordkeeping

requirements, Superfund, Water

pollution control, Water supply.

Dated: July 23, 1997.

Michelle D. Jordan,

Acting Regional Administrator, U.S. EPA,

Region V.

40 CFR part 300 is amended as

follows:

PART 300—[AMENDED]

1. The authority citation for part 300

continues to read as follows:

Authority: 33 U.S.C. 1321(c)(2); 42 U.S.C.

9601–9657; E.O. 12777, 56 FR 54757, 3 CFR,

1991 Comp.; p.351; E.O. 12580, 52 FR 2923,

3 CFR, 1987 Comp.; p. 193.

Appendix B [Amended]

2. Table 1 of Appendix B to part 300

is amended by removing the Site ‘‘Agate

Lake Scrapyard, Fairview Township,

Minnesota’’.

[FR Doc. 97–20174 Filed 7–31–97; 8:45 am]

BILLING CODE 6560–50–P

DEPARTMENT OF THE INTERIOR

Office of the Secretary

43 CFR Part 10

RIN 1024–AC07

Native American Graves Protection

and Repatriation Act Regulations

AGENCY: Department of the Interior

ACTION: Correcting amendments to final

regulations

SUMMARY: This document contains

corrections to the final regulations

which were published in the Federal

Register of Monday, December 4, 1995