30636 Federal Register / Vol. 63, No. 108 / Friday, June 5, 1998 /Rules and Regulations

‘‘Copyright Arbitration Royalty Panel

and/or Librarian of Congress.’’ and

adding in its place ‘‘the Copyright

Office.’’

28. Section 253.7(e) is amended by

removing the word ‘‘CRT’’ each place it

appears and adding in its place

‘‘Copyright Office’’.

PART 256—ADJUSTMENT OF

ROYALTY FEE FOR CABLE

COMPULSORY LICENSE

29. The authority citation for part 256

continues to read as follows:

Authority: 17 U.S.C. 702, 802.

§ 256.2 [Amended]

30. Section 256.2(b)(2) is amended by

removing the word ‘‘basis’’ before the

word ‘‘service’’ and adding in its place

the word ‘‘basic’’ and by removing the

word ‘‘that’’ after the word ‘‘more’’ and

adding in its place the word ‘‘than’’.

PART 257—FILING OF CLAIMS TO

SATELLITE CARRIER ROYALTY FEES

31. The authority citation for part 257

continues to read as follows:

Authority: 17 U.S.C. 119(b)(4).

§ 257.4 [Amended]

32. Section 257.4(a)(1) is amended by

removing the word ‘‘room’’ and adding

‘‘Room’’ in its place.

PART 258—ADJUSTMENT OF

ROYALTY FEE FOR SECONDARY

TRANSMISSIONS BY SATELLITE

CARRIERS

33. The authority citation for part 258

continues to read as follows:

Authority: 17 U.S.C. 702, 802.

§ 258.1 [Amended]

34. Section 258.1 is amended by

adding the word ‘‘the’’ after the word

‘‘under’’.

PART 259—FILING OF CLAIMS TO

DIGITAL AUDIO RECORDING DEVICES

AND MEDIA ROYALTY PAYMENTS

35. The authority citation for part 259

continues to read as follows:

Authority: 17 U.S.C. 1007(a)(1).

§ 259.5 [Amended]

36. Section 259.5(a)(1) is amended by

removing the word ‘‘room’’ and adding

‘‘Room’’ in its place.

PART 260—USE OF SOUND

RECORDINGS IN A DIGITAL

PERFORMANCE

37. The authority citation for part 260

continues to read as follows:

Authority: 17 U.S.C. 114, 801(b)(1).

§ 260.3 [Amended]

38. Section 260.3(e) is amended by

removing the word ‘‘accounts’’ after the

word ‘‘of’’ and adding in its place the

word ‘‘account’’.

Dated: June 1, 1998.

Marilyn J. Kretsinger,

Assistant General Counsel.

[FR Doc. 98–14824 Filed 6–4–98; 8:45 am]

BILLING CODE 1410–33–P

ENVIRONMENTAL PROTECTION

AGENCY

40 CFR Part 180

[OPP–300664; FRL–5793–6]

RIN 2070–AB78

Azoxystrobin; 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 azoxystrobin or methyl (E)-

2-(2-[6-(2-cyanophenoxy)pyrimidin-4-

yloxy]phenyl)-3-methoxyacrylate) and

its Z isomer in or on parsley . 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

parsley in Ohio. This regulation

establishes maximum permissible levels

for residues of azoxystrobin 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 June 30,

1999.

DATES: This regulation is effective June

5, 1998. Objections and requests for

hearings must be received by EPA on or

before August 4, 1998.

ADDRESSES: Written objections and

hearing requests, identified by the

docket control number, [OPP–300664],

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–

300664], 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–

300664]. 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: Virginia Dietrich, 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) 308-9359, e-mail:

dietrich.virginia@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 azoxystrobin and its Z isomer,

in or on fresh parsley at 0.5 and dried

parsley at 1.0 part per million (ppm).

This tolerance will expire and is

revoked on June 30, 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 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
Federal Register / Vol. 63, No. 108 / Friday, June 5, 1998 /Rules and Regulations 30637

under a new section 408 with a new

safety standard and new procedures.

These activities are described below and

discussed in greater detail in the final

rule establishing the time-limited

tolerance associated with the emergency

exemption for use of propiconazole on

sorghum (61 FR 58135, November 13,

1996)(FRL-5572-9).

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

FFDCA allows EPA to establish a

tolerance (the legal limit for a pesticide

chemical residue in or on a food) only

if EPA determines that the tolerance is

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

‘‘safe’’ to mean that ‘‘there is a

reasonable certainty that no harm will

result from aggregate exposure to the

pesticide chemical residue, including

all anticipated dietary exposures and all

other exposures for which there is

reliable information.’’ This includes

exposure through drinking water and in

residential settings, but does not include

occupational exposure. Section

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

consideration to exposure of infants and

children to the pesticide chemical

residue in establishing a tolerance and

to ‘‘ensure that there is a reasonable

certainty that no harm will result to

infants and children from aggregate

exposure to the pesticide chemical

residue. . . .’’

Section 18 of FIFRA authorizes EPA

to exempt any Federal or State agency

from any provision of FIFRA, if EPA

determines that ‘‘emergency conditions

exist which require such exemption.’’

This provision was not amended by

FQPA. EPA has established regulations

governing such emergency exemptions

in 40 CFR part 166.

Section 408(l)(6) of the FFDCA

requires EPA to establish a time-limited

tolerance or exemption from the

requirement for a tolerance for pesticide

chemical residues in food that will

result from the use of a pesticide under

an emergency exemption granted by

EPA under section 18 of FIFRA. Such

tolerances can be established without

providing notice or period for public

comment.

Because decisions on section 18-

related tolerances must proceed before

EPA reaches closure on several policy

issues relating to interpretation and

implementation of the FQPA, EPA does

not intend for its actions on such

tolerance to set binding precedents for

the application of section 408 and the

new safety standard to other tolerances

and exemptions.

II. Emergency Exemption for

Azoxystrobin on Parsley and FFDCA

Tolerances

The Ohio Department of Agriculture

requested an emergency exemption in

April of 1998 for the control of septoria

leaf blight in parsley. No foliar

fungicides are currently labeled for use

on parsley. Seed treatment

(disinfestation) is not practical due to

the high seeding rate used, and seed

testing does not appear to be sufficiently

sensitive to identify Septoria

contamination in seed lots. Once

Septoria leaf blight occurs in a field, the

field should not be planted to parsley or

other umbelliferous crops for 4-5 years.

Such long rotations are impractical for

muck crop production areas in Ohio due

to land availability restriction. Crop

rotation also cannot assure disease

control since the pathogen may

originate on the seed. For these reasons,

EPA has authorized under FIFRA

section 18 the use of azoxystrobin on

parsley for control of Septoria leaf blight

in parsley in Ohio.

As part of its assessment of this

emergency exemption, EPA assessed the

potential risks presented by residues of

azoxystrobin in or on parsley. 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 June 30, 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 parsley 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 azoxystrobin meets EPA’s

registration requirements for use on

parsley 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

azoxystrobin 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 Ohio 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 azoxystrobin, 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
30638 Federal Register / Vol. 63, No. 108 / Friday, June 5, 1998 /Rules and Regulations

is warranted. Thus, an aggregate daily

exposure to a pesticide residue at or

below the RfD (expressed as 100% or

less of the RfD) is generally considered

acceptable by EPA. EPA generally uses

the RfD to evaluate the chronic risks

posed by pesticide exposure. For shorter

term risks, EPA calculates a margin of

exposure (MOE) by dividing the

estimated human exposure into the

NOEL from the appropriate animal

study. Commonly, EPA finds MOEs

lower than 100 to be unacceptable. This

100-fold MOE is based on the same

rationale as the 100-fold uncertainty

factor.

Lifetime feeding studies in two

species of laboratory animals are

conducted to screen pesticides for

cancer effects. When evidence of

increased cancer is noted in these

studies, the Agency conducts a weight

of the evidence review of all relevant

toxicological data including short-term

and mutagenicity studies and structure

activity relationship. Once a pesticide

has been classified as a potential human

carcinogen, different types of risk

assessments (e.g., linear low dose

extrapolations or MOE calculation based

on the appropriate NOEL) will be

carried out based on the nature of the

carcinogenic response and the Agency’s

knowledge of its mode of action.

2. Differences in toxic effect due to

exposure duration. The toxicological

effects of a pesticide can vary with

different exposure durations. EPA

considers the entire toxicity data base,

and based on the effects seen for

different durations and routes of

exposure, determines which risk

assessments should be done to assure

that the public is adequately protected

from any pesticide exposure scenario.

Both short and long durations of

exposure are always considered.

Typically, risk assessments include

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

term,’’ and ‘‘chronic’’ risks. These

assessments are defined by the Agency

as follows.

Acute risk, by the Agency’s definition,

results from 1-day consumption of food

and water, and reflects toxicity which

could be expressed following a single

oral exposure to the pesticide residues.

High end exposure to food and water

residues are typically assumed.

Short-term risk results from exposure

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

and therefore overlaps with the acute

risk assessment. Historically, this risk

assessment was intended to address

primarily dermal and inhalation

exposure which could result, for

example, from residential pesticide

applications. However, since enaction of

FQPA, this assessment has been

expanded to include both dietary and

non-dietary sources of exposure, and

will typically consider exposure from

food, water, and residential uses when

reliable data are available. In this

assessment, risks from average food and

water exposure, and high-end

residential exposure, are aggregated.

High-end exposures from all three

sources are not typically added because

of the very low probability of this

occurring in most cases, and because the

other conservative assumptions built

into the assessment assure adequate

protection of public health. However,

for cases in which high-end exposure

can reasonably be expected from

multiple sources (e.g. frequent and

widespread homeowner use in a

specific geographical area), multiple

high-end risks will be aggregated and

presented as part of the comprehensive

risk assessment/characterization. Since

the toxicological endpoint considered in

this assessment reflects exposure over a

period of at least 7 days, an additional

degree of conservatism is built into the

assessment; i.e., the risk assessment

nominally covers 1-7 days exposure,

and the toxicological endpoint/NOEL is

selected to be adequate for at least 7

days of exposure. (Toxicity results at

lower levels when the dosing duration

is increased.)

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

(nonursing infants (<1year 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 azoxystrobin and to make a

determination on aggregate exposure,

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

time-limited tolerance for combined

residues of azoxystrobin and its Z

isomer) on fresh parsley at 0.5 and for

dried parsley at 1.0 ppm. EPA’s

assessment of the dietary exposures and

risks associated with establishing the

tolerance follows.

A. Toxicological Profile

EPA has evaluated the available

toxicity data and considered its validity,

completeness, and reliability as well as

the relationship of the results of the
Federal Register / Vol. 63, No. 108 / Friday, June 5, 1998 /Rules and Regulations 30639

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 and The Agency’s selection

of toxicological endpoints upon which

to assess risk caused by azoxystrobin are

discussed below.

1. Acute toxicity. The Agency

evaluated the existing toxicology

database for azoxystrobin and did not

identify an acute dietary endpoint.

Therefore, a risk assessment is not

required.

2. Short - and intermediate - term

toxicity. The Agency evaluated the

existing toxicology database for shortand intermediate-term dermal and

inhalation exposure and determined

that this risk assessment is not required.

Note: From a 21-day dermal toxicity study

the NOEL was 1,000 milligrams/kilogram/

day (mg/kg/day)( at the highest dose tested

(HDT) (Acute inhalation toxicity category III).

3. Chronic toxicity. EPA has

established the RfD for azoxystrobin at

0.18 mg/kg/day. This RfD is based on on

a chronic toxicity study in rats with a

NOEL of 18.2 mg/kg/day. Reduced body

weights and bile duct lesions were

observed at the lowest effect level (LEL)

of 34 mg/kg/day. An Uncertainty Factor

(UF) of 100 was used to account for both

the interspecies extrapolation and the

intraspecies variability.

4. Carcinogenicity. The HED RfD/Peer

Review Committee (November 7, 1996)

determined that azoxystrobin should be

classified as ‘‘Not Likely’’ to be a human

carcinogen according to the proposed

revised Cancer Guidelines. This

classification is based on the lack of

evidence of carcinogenicity in long-term

rat and mouse feeding studies.

B. Exposures and Risks

1. From food and feed uses.

Permanent tolerances have been

established (40 CFR 180.507(a)) for the

combined residues of azoxystrobin and

its Z isomer, in or on a variety of raw

agricultural commodities at levels

ranging from 0.01 ppm in pecans to 1.0

ppm in grapes. In addition, time-limited

tolerances have been established (40

CFR 180.507(b)) at levels ranging from

0.006 ppm in milk to 20 ppm in rice

hulls) in conjunction with previous

section 18 requests. Risk assessments

were conducted by EPA to assess

dietary exposures and risks from

azoxystrobin as follows:

i. Acute exposure and risk. Acute

dietary risk assessments are performed

for a food-use pesticide if a toxicological

study has indicated the possibility of an

effect of concern occurring as a result of

a one day or single exposure. The

Agency did not conduct an acute risk

assessment because no toxicological

endpoint of concern was identified

during review of available data.

ii. Chronic exposure and risk. In

conducting this chronic dietary risk

assessment, HED has made very

conservative assumptions -- 100% of all

commodities having azoxystrobin

tolerances will contain azoxystrobin

residues and those residues would be at

the level of the tolerance -- which result

in an overestimation of human dietary

exposure. Thus, in making a safety

determination for this tolerance, HED is

taking into account this conservative

exposure assessment.

The existing azoxystrobin tolerances

(published, pending, and including the

necessary section 18 tolerance(s)) result

in a Theoretical Maximum Residue

Contribution (TMRC) that is equivalent

to the following percentages of the RfD:

Population SubGroupTMRC (mg/

kg/day) % RFD

U.S. population (48

States).

0.002 1

Nursing infants (<1

year old).

0.004 2

Population SubGroupTMRC (mg/

kg/day) % RFD

Non-nursing infants

(<1 year old).

0.009 5

Children (1-6 years

old).

0.005 3

Children (7-12

years old).

0.003 2

Hispanics ............... 0.003 2

Non-Hispanics Others.0.005 3

U.S. Population

(summer season).

0.003 2

Females (13-19,

not pregnant or

nursing).

0.002 1

The subgroups listed above are: (a) the

U.S. population (48 states); (b) those for

infants and children; (c) females (13-19

years old, not pregnant or nursing); and,

(d) the other subgroups for which the

percentage of the RfD occupied is

greater than that occupied by the

subgroup U.S. population (48 States).

2. From drinking water. There is no

established Maximum Contaminant

Level for residues of azoxystrobin in

drinking water. No health advisory

levels for azoxystrobin in drinking water

have been established.

i. Acute exposure and risk. An

assessment was not appropriate since no

toxicological endpoint of concern was

identified during review of the available

data.

ii. Chronic exposure and risk. Based

on the chronic dietary (food) exposure

estimates, chronic drinking water levels

of concern (DWLOC) for azoxystrobin

were calculated and are summarized in

the following table. The highest EEC for

azoxystrobin in surface water is from

the application of azoxystrobin on

grapes (39 g/L) and is substantially

lower than the DWLOCs calculated.

Therefore, chronic exposure to

azoxystrobin residues in drinking water

do not exceed RAB2s level of concern.

DRINKING WATER LEVELS OF CONCERN

RfD (mg/kg/day) TMRC [Food Exposure]

(mg/kg/day)

Max Water Exposure1 (mg/kg/day) DWLOC 2,3,4 ( g/L)

US Population (48 States) ................................. 0.18 0.00231 0.178 6,200

Females (13 + years old, not pregnant or nursing).0.18 0.00176 0.178 5,300

Non-nursing Infants (< 1 year old) ..................... 0.18 0.00879 0.171 1,700

1 Maximum Water Exposure (mg/kg/day) = RfD (mg/kg/day) - TMRC from DRES (mg/kg/day) 2 DWLOC( g/L) = Max water exposure (mg/kg/day) * body wt (kg) /[(10-3 mg/ g)*water consumed daily (L/day)] 3 HED Default body wts for males, females, and children are 70 kg, 60 kg, and 10 kg respectively. 4 HED Default Daily Drinking Rates are 2 L/Day for Adults and 1 L/Day for children.

3. From non-dietary exposure.

Azoxystrobin is not currently registered

for use on residential non-food sites.

4. Cumulative exposure to substances

with common mechanism of toxicity.

Azoxystrobin is related to the naturally

occurring strobilurins. There are no

other members of this class of

fungicides registered with the Agency.
30640 Federal Register / Vol. 63, No. 108 / Friday, June 5, 1998 /Rules and Regulations

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

azoxystrobin 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,

azoxystrobin 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 azoxystrobin has a

common mechanism of toxicity with

other substances.

C. Aggregate Risks and Determination of

Safety for U.S. Population

1. Acute risk. This is not applicable

since no toxicological end-point of

concern was identified during review of

the available data.

2. Chronic risk. Using the

conservative TMRC exposure

assumptions described above, and

taking into account the completeness

and reliability of the toxicity data, HED

has estimated the exposure to

azoxystrobin from food will utilize 1%

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

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 azoxystrobin in drinking

water, HED does not expect the

aggregate exposure to exceed 100% of

the RfD. Under current HED guidelines,

the registered non-dietary uses of

azoxystrobin do not constitute a chronic

exposure scenario. HED concludes that

there is a reasonable certainty that no

harm will result from chronic aggregate

exposure to azoxystrobin residues. EPA

concludes that there is a reasonable

certainty that no harm will result from

aggregate exposure to azoxystrobin

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. This risk assessment is not

applicable since no indoor and outdoor

residential exposure uses are currently

registered for azoxystrobin.

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

azoxystrobin, 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.

Rabbit. In the developmental toxicity

study in rabbits, developmental NOEL

was 500 mg/kg/day, at the HDT.

Because there were no treatment-related

effects, the developmental LEL was

>500 mg/kg/day. The maternal NOEL

was 150 mg/kg/day. The maternal LEL

of 500 mg/kg/day was based on

decreased body weight gain during

dosing.

b. Rat. In the developmental toxicity

study in rats, the maternal (systemic)

NOEL was not established. The

maternal LEL of 25 mg/kg/day at the

lowest dose tested (LDT) was based on

increased salivation. The developmental

(fetal) NOEL was 100 mg/kg/day (HDT).

iii. Reproductive toxicity study— Rat.

In the reproductive toxicity study

(MRID #43678144) in rats, the parental

(systemic) NOEL was 32.3 mg/kg/day.

The parental LEL of 165.4 mg/kg/day

was based on decreased body weights in

males and females, decreased food

consumption and increased adjusted

liver weights in females, and

cholangitis. The reproductive NOEL was

32.3 mg/kg/day. The reproductive LEL

of 165.4 mg/kg/day was based on

increased weanling liver weights and

decreased body weights for pups of both

generations.

iv. Pre- and post-natal sensitivity. The

pre- and post-natal toxicology data base

for azoxystrobin is complete with

respect to current toxicological data

requirements. The results of these
Federal Register / Vol. 63, No. 108 / Friday, June 5, 1998 /Rules and Regulations 30641

studies indicate that infants and

children are not more sensitive to

exposure, based on the results of the rat

and rabbit developmental toxicity

studies and the 2-generation

reproductive toxicity study in rats. The

additional 10x safety factor to account

for sensitivity of infants and children

was removed by an ad hoc FQPA Safety

Factor Committee.

v. Conclusion. The results of these

studies indicate that infants and

children are not more sensitive to

exposure, based on the results of the rat

and rabbit developmental toxicity

studies and the 2-generation

reproductive toxicity study in rats. The

additional 10x safety factor to account

for sensitivity of infants and children

was removed by an ad hoc FQPA Safety

Factor Committee.

2. Chronic risk. Using the

conservative exposure assumptions

described above, EPA has concluded

that aggregate exposure to azoxystrobin

from food will utilize 2 to 5% 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 azoxystrobin 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 azoxystrobin

residues.

V. Other Considerations

A. Metabolism In Plants and Animals

1. The nature of the residue in grapes

is adequately understood. These data

are being translated for watercress for

this temporary tolerance.

2. The qualitative nature of the

residue in animals is adequately

understood for the purposes of this

section 18 request. A ruminant

metabolism study has been submitted,

however the animal metabolism data

have not been reviewed by the Office of

Pesticide Program’s Metabolism

Assessment Review Committee. The

residues of concern in ruminants

appears to be different from that of

plants. Unidentified metabolite

compounds, designated metabolites 2,

20, and 28, appear to be the major

components of the residue in ruminant

tissues. For the purposes of these timelimited tolerances for emergency

exemptions only, the residues of

concern in animal tissues are

azoxystrobin and its Z-isomer.

B. Analytical Enforcement Methodology

1. A method (SOP RAM 243/03, GLC/

NPD) to determine residues of

azoxystrobin and its Z isomer in banana,

peach, peanut, tomato, and wheat

commodities has been submitted. This

method has been independently

validated as per PR Notice 88-5. An

Agency validation of this method is

pending. The Agency concludes this

method is adequate for enforcement of

the requested section 18 tolerances on

plant commodities.

2. GLC/NPD method RAM 255/01 is

adequate for collection of residue data

for azoxystrobin in animal commodities.

Adequate independent method

validation and concurrent method

recovery data have been submitted.

Method SOP RAM 255/01 has been

submitted for Agency method

validation. RAB2 concludes this method

is adequate for enforcement of the

necessary section 18 tolerances on

livestock commodities.

C. Magnitude of Residues

Residues of azoxystrobin and its Z

isomer are not expected to exceed 0.5

ppm in/on fresh parsley and 1.0 ppm

in/on dried parsley as a result of this

section 18 use. Time-limited tolerances

should be established at this level.

D. International Residue Limits

There are no CODEX, Canadian, or

Mexican Maximum Residue Limits

(MRL) for azoxystrobin on parsley.

Thus, harmonization is not an issue for

these section 18 requests.

E. Rotational Crop Restrictions

Rotational crop data were previously

submitted. Based on this information, a

45 day plantback interval is appropriate

for all crops.

VI. Conclusion

Therefore, the tolerance is established

for combined residues of azoxystrobin

and its Z isomer in parsley at 0.5 and

for dried parsley at 1.0 ppm.

VII. Objections and Hearing Requests

The new FFDCA section 408(g)

provides essentially the same process

for persons to ‘‘object’’ to a tolerance

regulation issued by EPA under new

section 408(e) and (l)(6) as was provided

in the old section 408 and in section

409. However, the period for filing

objections is 60 days, rather than 30

days. EPA currently has procedural

regulations which govern the

submission of objections and hearing

requests. These regulations will require

some modification to reflect the new

law. However, until those modifications

can be made, EPA will continue to use

those procedural regulations with

appropriate adjustments to reflect the

new law.

Any person may, by August 4, 1998,

file written objections to any aspect of

this regulation and may also request a

hearing on those objections. Objections

and hearing requests must be filed with

the Hearing Clerk, at the address given

above (40 CFR 178.20). A copy of the

objections and/or hearing requests filed

with the Hearing Clerk should be

submitted to the OPP docket for this

rulemaking. The objections submitted

must specify the provisions of the

regulation deemed objectionable and the

grounds for the objections (40 CFR

178.25). Each objection must be

accompanied by the fee prescribed by

40 CFR 180.33(i). If a hearing is

requested, the objections must include a

statement of the factual issues on which

a hearing is requested, the requestor’s

contentions on such issues, and a

summary of any evidence relied upon

by the requestor (40 CFR 178.27). A

request for a hearing will be granted if

the Administrator determines that the

material submitted shows the following:

There is genuine and substantial issue

of fact; there is a reasonable possibility

that available evidence identified by the

requestor would, if established, resolve

one or more of such issues in favor of

the requestor, taking into account

uncontested claims or facts to the

contrary; and resolution of the factual

issues in the manner sought by the

requestor would be adequate to justify

the action requested (40 CFR 178.32).

Information submitted in connection

with an objection or hearing request

may be claimed confidential by marking

any part or all of that information as

CBI. Information so marked will not be

disclosed except in accordance with

procedures set forth in 40 CFR part 2.

A copy of the information that does not

contain CBI must be submitted for

inclusion in the public record.

Information not marked confidential

may be disclosed publicly by EPA

without prior notice.

VIII. Public Record and Electronic

Submissions

EPA has established a record for this

rulemaking under docket control

number [OPP–300664] (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.,
30642 Federal Register / Vol. 63, No. 108 / Friday, June 5, 1998 /Rules and Regulations

Monday through Friday, excluding legal

holidays. The public record is located in

Room 119 of the Public Information and

Records Integrity Branch, Information

Resources and Services Division

(7502C), Office of Pesticide Programs,

Environmental Protection Agency,

Crystal Mall #2, 1921 Jefferson Davis

Hwy., Arlington, VA.

Electronic comments may be sent

directly to EPA at:

opp-docket@epamail.epa.gov.

Electronic comments must be

submitted as an ASCII file avoiding the

use of special characters and any form

of encryption.

The official record for this

rulemaking, as well as the public

version, as described above will be kept

in paper form. Accordingly, EPA will

transfer any copies of objections and

hearing requests received electronically

into printed, paper form as they are

received and will place the paper copies

in the official rulemaking record which

will also include all comments

submitted directly in writing. The

official rulemaking record is the paper

record maintained at the Virginia

address in ‘‘ADDRESSES’’ at the

beginning of this document.

IX. Regulatory Assessment

Requirements

This final rule establishes a tolerance

under FFDCA section 408(d) in

response to a petition submitted to the

Agency. The Office of Management and

Budget (OMB) has exempted these types

of actions from review under Executive

Order 12866, entitled Regulatory

Planning and Review (58 FR 51735,

October 4, 1993). This final rule does

not contain any information collections

subject to OMB approval under the

Paperwork Reduction Act (PRA), 44

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

enforceable duty or contain any

unfunded mandate as described under

Title II of the Unfunded Mandates

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

104–4). Nor does it require any prior

consultation as specified by Executive

Order 12875, entitled Enhancing the

Intergovernmental Partnership (58 FR

58093, October 28, 1993), or special

considerations as required by Executive

Order 12898, entitled Federal Actions to

Address Environmental Justice in

Minority Populations and Low-Income

Populations (59 FR 7629, February 16,

1994), or require OMB review in

accordance with Executive Order 13045,

entitled Protection of Children from

Environmental Health Risks and Safety

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

In addition, since these tolerances and

exemptions that are established under

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

tolerance in this final rule, do not

require the issuance of a proposed rule,

the requirements of the Regulatory

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

seq.) do not apply. Nevertheless, the

Agency has previously assessed whether

establishing tolerances, exemptions

from tolerances, raising tolerance levels

or expanding exemptions might

adversely impact small entities and

concluded, as a generic matter, that

there is no adverse economic impact.

The factual basis for the Agency’s

generic certification for tolerance

actions published on May 4, 1981 (46

FR 24950), and was provided to the

Chief Counsel for Advocacy of the Small

Business Administration.

X. Submission to Congress and the

General Accounting Office

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

by the Small Business Regulatory

Enforcement Fairness Act of 1996, the

Agency has submitted a report

containing this rule and other required

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

House of Representatives, and the

Comptroller General of the General

Accounting Office prior to publication

of this rule in today’s Federal Register.

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

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

List of Subjects in 40 CFR Part 180

Environmental protection,

Administrative practice and procedure,

Agricultural commodities, Pesticides

and pests, Reporting and recordkeeping

requirements.

Dated: May 20, 1998.

James Jones,

Director, Registration Division, Office of

Pesticide Programs.

Therefore, 40 CFR chapter I is

amended as follows:

PART 180— [AMENDED]

1. The authority citation for part 180

continues to read as follows:

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

2. Section 180.507 is amended in

paragraph (b) by alphabetically adding

the following commodities to the table

to read as follows:

§ 180.507 Azoxystrobin; tolerances for

residues.

* * * * *

(b) * * *

Commodity Parts per

million

Expiration/

revocation

date

* * *

* * *

*

Parsley, dried .. 1.0 6/30/99

Parsley, fresh .. 0.5 6/30/99

* * *

* * *

*

* * * * *

[FR Doc. 98–15020 Filed 6–4–98; 8:45 am]

BILLING CODE 6560–50–F

FEDERAL EMERGENCY

MANAGEMENT AGENCY

44 CFR Part 64

[Docket No. FEMA–7689]

List of Communities Eligible for the

Sale of Flood Insurance

AGENCY: Federal Emergency

Management Agency (FEMA).

ACTION: Final rule.

SUMMARY: This rule identifies

communities participating in the

National Flood Insurance Program

(NFIP). These communities have

applied to the program and have agreed

to enact certain floodplain management

measures. The communities’

participation in the program authorizes

the sale of flood insurance to owners of

property located in the communities

listed.

EFFECTIVE DATES: The dates listed in the

third column of the table.

ADDRESSES: Flood insurance policies for

property located in the communities

listed can be obtained from any licensed

property insurance agent or broker

serving the eligible community, or from

the NFIP at: Post Office Box 6464,

Rockville, MD 20849, (800) 638–6620.

FOR FURTHER INFORMATION CONTACT:

Robert F. Shea, Jr., Division Director,

Program Implementation Division,

Mitigation Directorate, 500 C Street SW.,

room 417, Washington, DC 20472, (202)

646–3619.

SUPPLEMENTARY INFORMATION: The NFIP

enables property owners to purchase

flood insurance which is generally not

otherwise available. In return,

communities agree to adopt and

administer local floodplain management

measures aimed at protecting lives and

new construction from future flooding.