Federal Register / Vol. 63, No. 132 / Friday, July 10, 1998 /Rules and Regulations 37289

catenulatum strain J1446 when used in

or on all food commodities.

[FR Doc. 98–18277 Filed 7–9–98; 8:45 am]

BILLING CODE 6560–50–F

ENVIRONMENTAL PROTECTION

AGENCY

40 CFR Part 180

[OPP–300678; FRL–5798–6]

RIN 2070–AB78

Myclobutanil; Pesticide Tolerances for

Emergency Exemptions

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Final rule.

SUMMARY: This regulation establishes a

time-limited tolerance for combined

residues of myclobutanil in or on

caneberries, and in or on dried hop

cones. 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 caneberries in Oregon, and

use of the pesticide on hops in Idaho,

Oregon, and Washington. This

regulation establishes a maximum

permissible level for residues of

myclobutanil in these food commodities

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

Federal Food, Drug, and Cosmetic Act,

as amended by the Food Quality

Protection Act of 1996. The tolerances

will expire and be revoked on December

31, 1999.

DATES: This regulation is effective July

10, 1998. Objections and requests for

hearings must be received by EPA on or

before September 8, 1998.

ADDRESSES: Written objections and

hearing requests, identified by the

docket control number, [OPP–300678],

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–

300678], 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–

300678]. 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: David Deegan, 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) 308–9358, e-mail:

deegan.dave@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 combined residues of the

fungicide myclobutanil ù-butyl-ù-(4-

chlorophenyl)-1H-1,2,4-triazole-1-

propanenitrile plus its alcohol

metabolite ù-(3-hydroxybutyl)-ù-(4-

chlorophenyl)-1H-1,2,4-triazole-1-

propanenitrile (free and bound), in or on

caneberries at 1.0 part per million

(ppm), and in or on dried hop cones at

5.0 ppm. These tolerances will expire

and be revoked on December 31, 1999.

EPA will publish a document in the

Federal Register to remove the revoked

tolerance from the Code of Federal

Regulations.

I. Background and Statutory Authority

The Food Quality Protection Act of

1996 (FQPA) (Pub. L. 104–170) was

signed into law August 3, 1996. FQPA

amends both the Federal Food, Drug,

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

301 et seq., and the Federal Insecticide,

Fungicide, and Rodenticide Act

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

amendments went into effect

immediately. Among other things,

FQPA amends FFDCA to bring all EPA

pesticide tolerance-setting activities

under a new section 408 with a new

safety standard and new procedures.

These activities are described below and

discussed in greater detail in the final

rule establishing the time-limited

tolerance associated with the emergency

exemption for use of propiconazole on

sorghum (61 FR 58135, November 13,

1996)(FRL–5572–9).

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

FFDCA allows EPA to establish a

tolerance (the legal limit for a pesticide

chemical residue in or on a food) only

if EPA determines that the tolerance is

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

‘‘safe’’ to mean that ‘‘there is a

reasonable certainty that no harm will

result from aggregate exposure to the

pesticide chemical residue, including

all anticipated dietary exposures and all

other exposures for which there is

reliable information.’’ This includes

exposure through drinking water and in

residential settings, but does not include

occupational exposure. Section

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

consideration to exposure of infants and

children to the pesticide chemical

residue in establishing a tolerance and

to ‘‘ensure that there is a reasonable

certainty that no harm will result to

infants and children from aggregate

exposure to the pesticide chemical

residue. . . .’’

Section 18 of FIFRA authorizes EPA

to exempt any Federal or State agency

from any provision of FIFRA, if EPA

determines that ‘‘emergency conditions

exist which require such exemption.’’

This provision was not amended by

FQPA. EPA has established regulations

governing such emergency exemptions

in 40 CFR part 166.

Section 408(l)(6) of the FFDCA

requires EPA to establish a time-limited

tolerance or exemption from the

requirement for a tolerance for pesticide

chemical residues in food that will

result from the use of a pesticide under

an emergency exemption granted by

EPA under section 18 of FIFRA. Such

tolerances can be established without

providing notice or period for public

comment.

Because decisions on section 18-

related tolerances must proceed before

EPA reaches closure on several policy

issues relating to interpretation and

implementation of the FQPA, EPA does

not intend for its actions on such

tolerance to set binding precedents for

the application of section 408 and the

new safety standard to other tolerances

and exemptions.
37290 Federal Register / Vol. 63, No. 132 / Friday, July 10, 1998 /Rules and Regulations

II. Emergency Exemptions for

Myclobutanil on Caneberries and Hops

and FFDCA Tolerances

On March 25, 1998, EPA received a

request from the state of Oregon for an

exemption, as allowed under provisions

of FIFRA section 18, to authorize the

use of the fungicide myclobutanil [Rally

40W Fungicide, manufactured by Rohm

& Haas Company] to control orange rust

on caneberries (blackberries,

Boysenberries, and black raspberries).

The basis of the claimed emergency

situation is that orange rust is a new

pest for growers of caneberries in the

Willamette Valley of Oregon, and that

without use of this chemical (in

combination with other, non-chemical

control measures) this disease would be

likely to become widespread throughout

the Willamette Valley and other

agricultural areas of Oregon and

potentially neighboring states. Under

FIFRA section 18 provisions, on May

22, 1998 EPA authorized the use of

myclobutanil on caneberries for control

of orange rust in Oregon. EPA’s

authorization allows up to five ground

applications of the product at a rate of

0.125 lbs. active ingredient (5 oz.

product) on 730 acres. The exemption

expires on November 1, 1998.

On January 9, 1998, EPA received a

regional request from the states of Idaho,

Oregon, and Washington for an

exemption, as allowed under provisions

of FIFRA section 18, to authorize the

use of the fungicide myclobutanil [Rally

40WSP, Manufactured by Rohm & Haas

Company] to control powdery mildew

on hops. The emergency situation

described was that powdery mildew is

a new pest for hops in the applicant

states, and the disease has very rapidly

become established and has not been

controlled adequately by non-chemical

measures, and that there are no other

products registered for use on hops to

control powdery mildew. On May 5,

1998 EPA authorized the use of

myclobutanil on hops for control of

powdery mildew in Idaho, Oregon, and

Washington. EPA’s authorization allows

up to eight ground or aerial applications

of the product at a rate of 0.05 – 0.25

lbs. active ingredient (2 – 10 oz.

product) on 44,730 acres within the

three states. These exemptions expire on

October 1, 1998.

As part of its assessment of this

emergency exemption, EPA assessed the

potential risks presented by residues of

myclobutanil in or on caneberries and

in or on hops. 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 these tolerances will

expire and be revoked on December 31,

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

residues of the pesticide not in excess

of the amounts specified in the

tolerance remaining in or on caneberries

or dried hop cones after that date will

not be unlawful, provided the pesticide

is applied in a manner that was lawful

under FIFRA, and the residues do not

exceed a level that was authorized by

this tolerance at the time of that

application. EPA will take action to

revoke this tolerance earlier if any

experience with, scientific data on, or

other relevant information on this

pesticide indicate that the residues are

not safe.

Because this tolerance is being

approved under emergency conditions

EPA has not made any decisions about

whether myclobutanil meets EPA’s

registration requirements for use on

caneberries or hops, or whether

permanent tolerances for these uses

would be appropriate. Under these

circumstances, EPA does not believe

that this tolerance serves as a basis for

registration of myclobutanil by a State

for special local needs under FIFRA

section 24(c). Nor does this tolerance

serve as the basis for any State other

than those listed above to use this

pesticide on these crops 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 myclobutanil, 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 percent

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 hundredfold MOE is

based on the same rationale as the

hundredfold 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
Federal Register / Vol. 63, No. 132 / Friday, July 10, 1998 /Rules and Regulations 37291

carcinogenic response and the Agency’s

knowledge of its mode of action.

2. Differences in toxic effect due to

exposure duration. The toxicological

effects of a pesticide can vary with

different exposure durations. EPA

considers the entire toxicity data base,

and based on the effects seen for

different durations and routes of

exposure, determines which risk

assessments should be done to assure

that the public is adequately protected

from any pesticide exposure scenario.

Both short and long durations of

exposure are always considered.

Typically, risk assessments include

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

term,’’ and ‘‘chronic’’ risks. These

assessments are defined by the Agency

as follows.

Acute risk, by the Agency’s definition,

results from 1–day consumption of food

and water, and reflects toxicity which

could be expressed following a single

oral exposure to the pesticide residues.

High end exposure to food and water

residues are typically assumed.

Short-term risk results from exposure

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

and therefore overlaps with the acute

risk assessment. Historically, this risk

assessment was intended to address

primarily dermal and inhalation

exposure which could result, for

example, from residential pesticide

applications. However, since enaction of

FQPA, this assessment has been

expanded to include both dietary and

non-dietary sources of exposure, and

will typically consider exposure from

food, water, and residential uses when

reliable data are available. In this

assessment, risks from average food and

water exposure, and high-end

residential exposure, are aggregated.

High-end exposures from all three

sources are not typically added because

of the very low probability of this

occurring in most cases, and because the

other conservative assumptions built

into the assessment assure adequate

protection of public health. However,

for cases in which high-end exposure

can reasonably be expected from

multiple sources (e.g. frequent and

widespread homeowner use in a

specific geographical area), multiple

high-end risks will be aggregated and

presented as part of the comprehensive

risk assessment/characterization. Since

the toxicological endpoint considered in

this assessment reflects exposure over a

period of at least 7 days, an additional

degree of conservatism is built into the

assessment; i.e., the risk assessment

nominally covers 1–7 days exposure,

and the toxicological endpoint/NOEL is

selected to be adequate for at least 7

days of exposure. (Toxicity results at

lower levels when the dosing duration

is increased.)

Intermediate-term risk results from

exposure for 7 days to several months.

This assessment is handled in a manner

similar to the short-term risk

assessment.

Chronic risk assessment describes risk

which could result from several months

to a lifetime of exposure. For this

assessment, risks are aggregated

considering average exposure from all

sources for representative population

subgroups including infants and

children.

B. Aggregate Exposure

In examining aggregate exposure,

FFDCA section 408 requires that EPA

take into account available and reliable

information concerning exposure from

the pesticide residue in the food in

question, residues in other foods for

which there are tolerances, residues in

groundwater or surface water that is

consumed as drinking water, and other

non-occupational exposures through

pesticide use in gardens, lawns, or

buildings (residential and other indoor

uses). Dietary exposure to residues of a

pesticide in a food commodity are

estimated by multiplying the average

daily consumption of the food forms of

that commodity by the tolerance level or

the anticipated pesticide residue level.

The Theoretical Maximum Residue

Contribution (TMRC) is an estimate of

the level of residues consumed daily if

each food item contained pesticide

residues equal to the tolerance. In

evaluating food exposures, EPA takes

into account varying consumption

patterns of major identifiable subgroups

of consumers, including infants and

children.The TMRC is a ‘‘worst case’’

estimate since it is based on the

assumptions that food contains

pesticide residues at the tolerance level

and that 100% of the crop is treated by

pesticides that have established

tolerances. If the TMRC exceeds the RfD

or poses a lifetime cancer risk that is

greater than approximately one in a

million, EPA attempts to derive a more

accurate exposure estimate for the

pesticide by evaluating additional types

of information (anticipated residue data

and/or percent of crop treated data)

which show, generally, that pesticide

residues in most foods when they are

eaten are well below established

tolerances.

Percent of crop treated estimates are

derived from federal and private market

survey data. Typically, a range of

estimates are supplied and the upper

end of this range is assumed for the

exposure assessment. By using this

upper end estimate of percent of crop

treated, the Agency is reasonably certain

that exposure is not understated for any

significant subpopulation group.

Further, regional consumption

information is taken into account

through EPA’s computer-based model

for evaluating the exposure of

significant subpopulations including

several regional groups, to pesticide

residues. For this pesticide, the most

highly exposed population subgroup

(non-nursing infants < 1 year old) was

not regionally based.

IV. Aggregate Risk Assessment and

Determination of Safety

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

EPA has reviewed the available

scientific data and other relevant

information in support of this action,

EPA has sufficient data to assess the

hazards of myclobutanil and to make a

determination on aggregate exposure,

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

time-limited tolerance for combined

residues of myclobutanil on caneberries

at 1.0 ppm and for combined residues

of myclobutanil on dried hop cones at

5.0 ppm. EPA’s assessment of the

dietary exposures and risks associated

with establishing the tolerance follows.

A. Toxicological Profile

EPA has evaluated the available

toxicity data and considered its validity,

completeness, and reliability as well as

the relationship of the results of the

studies to human risk. EPA has also

considered available information

concerning the variability of the

sensitivities of major identifiable

subgroups of consumers, including

infants and children. The nature of the

toxic effects caused by myclobutanil are

discussed below.

1. Acute toxicity. None. For acute

dietary risk assessment, EPA has not

recommended an acute dietary

endpoint.

2. Chronic toxicity. EPA has

established the RfD for myclobutanil at

0.025 milligrams/kilogram/day (mg/kg/

day). This RfD is based on the NOEL

from the chronic feeding study in the rat

(2.49 mg/kg/day) and a safety factor of

100 (10 for intraspecies and 10 for

interspecies). The LOEL for the chronic

rat feeding study is 9.84 mg/kg/day

based on decreased testicular weight

and increased testicular atrophy. EPA’s

assessment notes that the dose of 2.49

mg/kg/day established in the above

study is supported by the Parental

Systemic Toxicity NOEL and LOEL

established in the Two-Generation

reproduction study in rats. In that study

the NOEL was 2.5 mg/kg/day and the

LOEL was 10 mg/kg/day. EPA has

determined that the 10X factor to
37292 Federal Register / Vol. 63, No. 132 / Friday, July 10, 1998 /Rules and Regulations

account for enhanced sensitivity of

infants and children (as required by

FQPA) should be removed. A safety

factor of 100 is adequate because of the

following:

i. Developmental toxicity studies

showed no increased sensitivity in

fetuses as compared to maternal animals

following in utero exposures in rats and

rabbits.

ii. A two generation reproduction

toxicity study in rats showed no

increased sensitivity in pups that were

compared to adults.

iii. The toxicology data base is

complete and there are no data gaps.

3. Carcinogenicity. Myclobutanil is

classified as Category E: not

carcinogenic in two acceptable animal

studies. Q1* is not applicable.

B. Exposures and Risks

1. From food and feed uses.

Tolerances have been established (40

CFR 180.443) for the combined residues

of myclobutanil, in or on a variety of

raw agricultural commodities.

Tolerances have been established for the

residues of myclobutanil ù-butyl-ù-(4-

chlorophenyl)-1H-1,2,4-triazole-1-

propanenitrile and its metabolite ù-(3-

hydroxybutyl)-ù-(4-chlorophenyl)-1H1,2,4-triazole-1-propanenitrile (free and

bound), expressed as myclobutanil, in

or on a variety of raw agricultural

commodities and processed

commodities at levels ranging from 0.02

ppm in cottonseed to 25.0 ppm in raisin

waste. Meat, milk, poultry and egg

tolerances have been established at

levels ranging from 0.02 ppm to 1.0

ppm. Risk assessments were conducted

by EPA to assess dietary exposures and

risks from myclobutanil as follows:

i. Acute exposure and risk. If

applicable. Acute dietary risk

assessments are performed for a fooduse pesticide if a toxicological study has

indicated the possibility of an effect of

concern occurring as a result of a one

day or single exposure. In performing its

assessment of the risks from residues of

myclobutanil, EPA has not

recommended an acute dietary

toxicological endpoint, so an acute

dietary risk assessment is not required.

ii. Chronic exposure and risk. In

conducting this chronic dietary (food

only) risk assessment, EPA has made

somewhat conservative assumptions.

This results in an overestimate of

human dietary exposure. Percent croptreated estimates were utilized for

selected commodities included in the

assessment. Thus, in making a safety

determination for this tolerance, EPA is

taking into account this partially refined

exposure assessment.

The existing myclobutanil tolerances

(published, pending, and including the

necessary section 18 tolerances) result

in an Anticipated Residue Contribution

(ARC) that is equivalent to the following

percentages of the RfD, ranging from

17% (U.S. population, 48 states) to 75%

(non-nursing infants, < 1 year old).

2. From drinking water—chronic

exposure and risk. Based on information

available to EPA, myclobutanil is

persistent and not considered mobile in

soils with the exception of sandy soils.

Data are not available for its metabolite

alpha-(3-hydroxybutyl)-alpha-(4-

chlorophenyl)-1H-1,2,4-triazole-1-

propanenitrile. There is no established

Maximum Contaminant Level for

residues of myclobutanil in drinking

water. No Health Advisory Levels for

myclobutanil in drinking water have

been established. The ‘‘Pesticides in

Groundwater Database’’ (EPA 734–12–

92–001, September 1992) has no

information concerning myclobutanil.

EPA has estimated ground and surface

water concentrations for myclobutanil

based on the label rate of 0.65 lbs a.i./

acre and assuming 15 applications per

season. (These numbers were based on

turf uses.)

Surface water EEC: Acute = 145.96

ppb (0.14596 ppm or milligrams/liter

(mg/l))(maximum initial concentration)

Chronic = 118.6 ppb (0.1186 ppm or

mg/l)(average 56–day concentration)

Ground water EEC: 3.6 ppb (0.0036

ppm or mg/l) (use for both acute and

chronic)

EPA has calculated drinking water

levels of concern (DWLOCs) for chronic

(non-cancer) exposure to be 0.7 ppm for

U.S. population, 0.6 ppm for Hispanics,

and 0.06 ppm for non-nursing infants (<

1 year old ).

The estimated average concentration

of myclobutanil in surface water is 0.04

ppm. Chronic concentrations in ground

water are not expected to be higher than

the acute concentrations. The estimated

average concentrations of myclobutanil

in surface water are less than EPA’s

levels of concern for myclobutanil in

drinking water as a contribution to

chronic aggregate exposure. Therefore,

taking into account the present uses and

uses proposed in this action, EPA

concludes with reasonable certainty that

residues of myclobutanil in drinking

water (when considered along with

other sources of exposure for which

EPA has reliable data) would not result

in unacceptable levels of aggregate

human health risk at this time.

EPA bases this determination on a

comparison of estimated concentrations

of myclobutanil in surface waters and

ground waters to back-calculated ‘‘levels

of concern’’ for myclobutanil in

drinking water. These levels of concern

in drinking water were determined after

EPA has considered all other nonoccupational human exposures for

which it has reliable data, including all

current uses, and uses considered in

this action. The estimates of

myclobutanil in surface waters are

derived from water quality models that

use conservative assumptions (healthprotective) regarding the pesticide

transport from the point of application

to surface and ground water. Because

EPA considers the aggregate risk

resulting from multiple exposure

pathways associated with a pesticide’s

uses, levels of concern in drinking water

may vary as those uses change. If new

uses are added in the future, EPA will

reassess the potential impacts of

myclobutanil on drinking water as a

part of the aggregate risk assessment

process.

3. From non-dietary exposure.

Myclobutanil is currently registered for

use on the following residential nonfood sites: outdoor residential and

greenhouse use on annuals, perennials,

turf, shrubs, trees, and flowers.

Short- and intermediate-term

exposure and risk. EPA has determined

that these uses do not constitute a

chronic exposure scenario, but may

constitute a short- to intermediate-term

exposure scenario. The intermediateterm potential exposure would come

from Post-application (dermal for adult;

and dermal + ingestion of soil only, due

to the persistence of the pesticide in

soil, for toddlers). Other intermediateterm exposure scenarios are unlikely as

dissipation is strongly influenced by the

growth of the grass which needs weekly

mowing (more frequently in spring) and

most dissipation studies on lawns show

considerable tailing off of residues by

day 3 or 4; thus, the expectation of

significant residues is very unlikely.

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
Federal Register / Vol. 63, No. 132 / Friday, July 10, 1998 /Rules and Regulations 37293

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

myclobutanil 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,

myclobutanil 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 myclobutanil has a

common mechanism of toxicity with

other substances.

C. Aggregate Risks and Determination of

Safety for U.S. Population

1. Chronic risk. Using the partially

refined exposure assumptions described

above, EPA has concluded that

aggregate exposure (food, water, and

residential) to myclobutanil will not

exceed EPA’s level of concern. For the

U.S. population, 17% of the RfD is

occupied by dietary (food) exposure.

The estimated average concentrations of

myclobutanil in surface and ground

water are less than EPA’s levels of

concern for myclobutanil in drinking

water as a contribution to chronic

aggregate exposure. Therefore, EPA

concludes with reasonable certainty that

residues of myclobutanil in drinking

water do not contribute significantly to

the aggregate chronic human health risk

at the present time considering the

present uses and uses proposed in this

action. EPA has determined that the

outdoor registered uses of myclobutanil

would not fall under a chronic exposure

scenario. EPA concludes that there is a

reasonable certainty that no harm will

result from aggregate chronic exposure

to myclobutanil residues.

2. 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. The short-term NOEL for

dermal exposure is based on a dermal

exposure toxicity study. Since the NOEL

is based on a dermal study, oral

exposures generally cannot be used

directly to calculate a short-term

aggregate exposure. However, as EPA

determined that a dermal absorption

factor of 100% should be used for risk

assessment, oral exposures need not be

multiplied by a modifying factor

(converted to dermal equivalents) so

that they can be compared to the dermal

endpoint. Calculated MOEs were

acceptable.

There is a potential for short-term

exposure from drinking water. However,

as estimated average concentrations of

myclobutanil in surface and ground

water are less than EPA’s levels of

concern for drinking water as a

contribution to chronic aggregate and

acute aggregate exposures, contribution

to short-term exposure should not

exceed EPA’s levels of concern either.

EPA concludes that short-term

aggregate MOEs for adults are

acceptable considering the default

assumptions used in the derivation of

exposure estimates and the fact that a

LOEL was not identified in the 28–day

rat dermal toxicity study [the HDT was

the NOEL in this study] used to

determine the MOE. Chemical-specific

dissipation data and residential use/

usage information are required to

further refine these post-application

exposure estimates.

3. Intermediate-term aggregate risk.

There is a potential for intermediateterm exposure from drinking water.

However, as estimated average

concentrations of myclobutanil in

surface and ground water are less than

EPA’s levels of concern for drinking

water as a contribution to chronic

aggregate and acute aggregate exposures,

contribution to intermediate-term

exposure should not exceed EPA’s

levels of concern either.

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

myclobutanil, 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— a.

Rats. In the developmental study in rats,

the maternal (systemic) NOEL was 93.8

mg/kg/day, based on rough hair coat,

and salivation at the LOEL of 312.6 mg/

kg/day. The developmental (fetal) NOEL

was 93.8 mg/kg/day based on

incidences of 14th rudimentary and 7th

cervical ribs at the LOEL of 312.6 mg/

kg/day.

b. Rabbits. In the developmental

toxicity study in rabbits, the maternal

(systemic) NOEL was 60 mg/kg/day,

based on reduced weight gain, clinical

signs of toxicity and abortions at the
37294 Federal Register / Vol. 63, No. 132 / Friday, July 10, 1998 /Rules and Regulations

LOEL of 200 mg/kg/day. The

developmental (fetal) NOEL was 60 mg/

kg/day, based on increases in number of

resorptions, decreases in litter size, and

a decrease in the viability index at the

LOEL of 200 mg/kg/day.

iii. Reproductive toxicity study—Rats.

In the 2-generation reproductive toxicity

study in rats, the parental (systemic)

NOEL was 2.5 mg/kg/day, based on

increased liver weights and liver cell

hypertrophy at the LOEL of 10 mg/kg/

day. The developmental (pup) NOEL

was 10 mg/kg/day, based on decreased

pup body weight during lactation at the

LOEL of 50 mg/kg/day. The

reproductive (pup) NOEL was 10 mg/kg/

day, based on the increased incidence of

stillborns, and atrophy of the testes,

epididymides, and prostate at the lowest

effect level of 50 mg/kg/day.

iv. Pre- and post-natal sensitivity. The

pre- and post-natal toxicology data base

for myclobutanil is complete with

respect to current toxicological data

requirements. Based on the

developmental and reproductive

toxicity studies discussed above, for

myclobutanil there does not appear to

be an extra sensitivity for pre- or postnatal effects.

v. Conclusion. Based on the above,

EPA concludes that reliable data

support use of a hundredfold margin of

exposure/uncertainty factor, rather than

the standard thousandfold margin/

factor, to protect infants and children.

2. Chronic risk. Using the partially

refined exposure assumptions described

above, EPA has concluded that the

percent of the RfD that will be utilized

by dietary (food only) exposure to

residues of myclobutanil ranges from

25% for nursing infants (< 1 year old)

up to 75% for non-nursing infants (< 1

year old). Despite the potential for

exposure to myclobutanil in drinking

water, HED does not expect the chronic

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 myclobutanil

residues.

3. Short-term aggregate risk. The

short-term NOEL for dermal exposure is

based on a dermal exposure toxicity

study. Since the NOEL is based on a

dermal study, oral exposures generally

cannot be used directly to calculate a

short-term aggregate exposure. However,

as EPA determined that a dermal

absorption factor of 100% should be

used for risk assessment, oral exposures

need not be multiplied by a modifying

factor (converted to dermal equivalents)

so that they can be compared to the

dermal endpoint.

The chronic dietary exposure and

calculated dietary MOE for infants (nonnursing, < 1 year old) was acceptable.

For the short-term aggregate risk of the

most highly exposed subgroup (nonnursing infants (< 1 year old)), the

calculated MOE is 120. There is a

potential for short-term exposure from

drinking water. However, as estimated

average concentrations of myclobutanil

in surface and ground water are less

than EPA’s levels of concern for

drinking water as a contribution to

chronic aggregate and acute aggregate

exposures, contribution to short-term

exposure should not exceed EPA’s

levels of concern either. EPA concludes

that short-term aggregate MOEs for nonnursing infants (< 1 year old) are

acceptable.

4. Intermediate-term aggregate risk.

The intermediate-term NOEL for dermal

exposure is based on an oral exposure

toxicity study. EPA has determined that

a dermal absorption factor of 100%

should be used for this risk assessment.

The chronic dietary exposure from

myclobutanil is 0.018836 mg/kg/day.

The calculated myclobutanil dietary

MOE for non-nursing infants (< 1 year

old) is 530, which is acceptable. There

is a potential for intermediate-term

exposure from drinking water. However,

as estimated average concentrations of

myclobutanil in surface and ground

water are less than EPA’s levels of

concern for drinking water as a

contribution to chronic aggregate and

acute aggregate exposures, contribution

to intermediate-term exposure should

not exceed EPA’s levels of concern

either.

V. Other Considerations

A. Metabolism in Plants and Animals

The nature of the residue in plants is

adequately understood. The residue of

concern is myclobutanil plus its alcohol

metabolite (free and bound), as specified

in 40 CFR 180.443(a).

B. Analytical Enforcement Methodology

An adequate enforcement method is

available to enforce the established

tolerances. Quantitation is by GLC using

an Nitrogen/Phosphorus detector for

myclobutanil and an Electron Capture

detector (Ni63) for residues measured as

the alcohol metabolite. A copy of this

method is on file within EPA, using the

identification code of PP 4E4302.

C. Magnitude of Residues

Six field trials were conducted

between 1992 and 1994 in OH (2), WA

(1), MS (1), NJ (1), and OR (1). In all but

one trial, eight applications of rates

ranging from 0.15–1.0 oz. ai/A were

made. The one trial had only four

applications. Blackberries and

raspberries were harvested at 0, 3, and

7 PHI, except in one raspberry trial in

which the PHIs were 0, 4, and 8 day.

The results at 1X show a range of

residues of 0.03–0.39 ppm for parent

myclobutanil and < 0.02 for the alcohol

metabolite. Residues of myclobutanil

and its alcohol metabolite are not

expected to exceed 1.0 ppm in/on

caneberries as a result of this section 18

use. A time-limited tolerance for the

combined residues of myclobutanil and

its alcohol metabolite (free and bound)

should be established at this level.

Secondary residues are not expected

in animal commodities as no feedstuffs

are associated with these section 18

uses. Meat/milk/poultry/egg tolerances

have been established as a result of

other myclobutanil uses.

D. International Residue Limits

There are no Codex, Canadian or

Mexican residue limits established for

myclobutanil and its metabolites on the

commodities included in these section

18 requests. Thus, harmonization is not

an issue for these section 18 actions.

E. Rotational Crop Restrictions

Information concerning the likelihood

of residues in rotational crops is not

available for myclobutanil. As

caneberries and hopes are normally not

rotated, issues pertaining to rotational

crops are not applicable to this petition.

VI. Conclusion

Therefore, the tolerance is established

for combined residues of myclobutanil

in caneberries at 1.0 ppm; and for

combined residues of myblobutanil in/

on dried hop cones 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 September 8,

1998, file written objections to any

aspect of this regulation and may also

request a hearing on those objections.
Federal Register / Vol. 63, No. 132 / Friday, July 10, 1998 /Rules and Regulations 37295

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 and Electronic

Submissions

EPA has established a record for this

rulemaking under docket control

number [OPP–300678] (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

Highway, Arlington, VA.

Electronic comments may be sent

directly to EPA at:

opp-docket@epamail.epa.gov.

Electronic comments must be

submitted as an ASCII file avoiding the

use of special characters and any form

of encryption.

The official record for this

rulemaking, as well as the public

version, as described above will be kept

in paper form. Accordingly, EPA will

transfer any copies of objections and

hearing requests received electronically

into printed, paper form as they are

received and will place the paper copies

in the official rulemaking record which

will also include all comments

submitted directly in writing. The

official rulemaking record is the paper

record maintained at the Virginia

address in ‘‘ADDRESSES’’ at the

beginning of this document.

IX. Regulatory Assessment

Requirements

This action finalizes a tolerance under

FFDCA section 408(e). The Office of

Management and Budget (OMB) has

exempted these types of actions from

review under Executive Order 12866,

entitled Regulatory Planning and

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

In addition, this final rule does not

contain any information collections

subject to OMB approval under the

Paperwork Reduction Act (PRA), 44

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

enforceable duty or contain any

unfunded mandate as described under

Title II of the Unfunded Mandates

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

104–4). Nor does it require any prior

consultation as specified by Executive

Order 12875, entitled Enhancing the

Intergovernmental Partnership (58 FR

58093, October 28, 1993), or special

considerations as required by Executive

Order 12898, entitled Federal Actions to

Address Environmental Justice in

Minority Populations and Low-Income

Populations (59 FR 7629, February 16,

1994), or require special 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, under the Regulatory

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

seq.), the Agency 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 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 the 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 25, 1998.

James Jones,

Director, Registration Division, Office of

Pesticide Programs.

Therefore, 40 CFR chapter I is

amended as follows:

PART 180—[AMENDED]

1. The authority citation for part 180

continues to read as follows:

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

2. In § 180.443, by adding new entries

for caneberries and hop cones, dried in

alphabetical order to the table in

paragraph (b), to read as follows:

§ 180.443 Myclobutanil; tolerances for

residues.

* * * * *

(b) Section 18 emergency exemptions.

* * *

Commodity Parts per

million

Expiration/

Revocation

Date

Caneberries ....... 1.0 12/31/99

* * * *

*

Hop cones, dried 5.0 12/31/99

* * * *

*

* * * * *

[FR Doc. 98–18278 Filed 7–9–98; 8:45 am]

BILLING CODE 6560–50–F