26082 Federal Register / Vol. 63, No. 91 /Tuesday, May 12, 1998 /Rules and Regulations

section, the applicability shall be based

on the utilization that occurred during

the year preceding April 22, 1994.

(B) For chemical manufacturing

process units that produce one or more

of the chemicals listed in paragraph

(b)(1)(ii) of this section and meet the

criteria in paragraphs (b)(2) and (b)(3) of

this section, the applicability shall be

based on the utilization that occurred

during the year preceding May 12, 1998.

* * * * *

(k) Except as provided in paragraphs

(l), (m), and (p) of this section, sources

subject to subparts F, G, or H of this part

are required to achieve compliance on

or before the dates specified in

paragraphs (k)(1) through (k)(8) of this

section.

* * * * *

(l)(1) * * *

(ii)(A) Such construction commenced

after December 31, 1992 for chemical

manufacturing process units that

produce as a primary product one or

more of the chemicals listed in table 1

of this subpart;

(B) Such construction commenced

after August 22, 1997 for chemical

manufacturing process units that

produce as a primary product one or

more of the chemicals listed in

paragraph (b)(1)(ii) of this section; and

* * * * *

(2) * * *

(ii)(A) Such reconstruction

commenced after December 31, 1992 for

chemical manufacturing process units

that produce as a primary product one

or more of the chemicals listed in table

1 of this subpart; and

(B) Such construction commenced

after August 22, 1997 for chemical

manufacturing process units that

produce as a primary product one or

more of the chemicals listed in

paragraph (b)(1)(ii) of this section.

* * * * *

(p) Compliance dates for chemical

manufacturing process units that

produce crotonaldehyde or

tetrahydrobenzaldehyde.

Notwithstanding the provisions of

paragraph (k) of this section, chemical

manufacturing process units that meet

the criteria in paragraphs (b)(1)(ii),

(b)(2), and (b)(3) of this section shall be

in compliance with this subpart and

subparts G and H of this part by the

dates specified in paragraphs (p)(1) and

(p)(2) of this section, as applicable.

(1) If the source consists only of

chemical manufacturing process units

that produce as a primary product one

or more of the chemicals listed in

paragraph (b)(1)(ii) of this section, new

sources shall comply by the date

specified in paragraph (p)(1)(i) of this

section and existing sources shall

comply by the dates specified in

paragraphs (p)(1)(ii) and (p)(1)(iii) of

this section.

(i) Upon initial start-up or May 12,

1998, whichever is later.

(ii) This subpart and subpart G of this

part by May 14, 2001, unless an

extension has been granted by the

Administrator as provided in

§ 63.151(a)(6) or granted by the

permitting authority as provided in

§ 63.6(i) of subpart A of this part. When

April 22, 1994 is referred to in this

subpart and subpart G of this part, May

12, 1998 shall be used as the applicable

date for that provision. When December

31, 1992 is referred to in this subpart

and subpart G of this part, August 22,

1997 shall be used as the applicable

date for that provision.

(iii) Subpart H of this part by May 12,

1999, unless an extension has been

granted by the Administrator as

provided in § 63.151(a)(6) or granted by

the permitting authority as provided in

§ 63.6(i) of subpart A of this part. When

April 22, 1994 is referred to in subpart

H of this part, May 12, 1998 shall be

used as the applicable date for that

provision. When December 31, 1992 is

referred to in subpart H of this part,

August 22, 1997 shall be used as the

applicable date for that provision.

(2) If the source consists of a

combination of chemical manufacturing

process units that produce as a primary

product one or more of the chemicals

listed in paragraphs (b)(1)(i) and

(b)(1)(ii) of this section, new chemical

manufacturing process units that meet

the criteria in paragraph (b)(1)(ii) of this

section shall comply by the date

specified in paragraph (p)(1)(i) of this

section and existing chemical

manufacturing process units producing

crotonaldehyde and/or

tetrahydrobenzaldehyde shall comply

by the dates specified in paragraphs

(p)(1)(ii) and (p)(1)(iii) of this section.

3. Section 63.103 is amended by

adding paragraph (b)(6) to read as

follows:

§ 63.103 General compliance, reporting,

and recordkeeping provisions.

* * * * *

(b) * * *

(6) The owner or operator of a flexible

operation unit shall conduct all required

compliance demonstrations during

production of the primary product. The

owner or operator is not required to

conduct compliance demonstrations for

operating conditions during production

of a product other than the primary

product. Except as otherwise provided

in this subpart or in subpart G or

subpart H of this part, as applicable, the

owner or operator shall operate each

control device, recovery device, and/or

recapture device that is required or used

for compliance, and associated

monitoring systems, without regard for

whether the product that is being

produced is the primary product or a

different product. Except as otherwise

provided in this subpart, subpart G and/

or subpart H of this part, as applicable,

operation of a control device, recapture

device and/or recovery device required

or used for compliance such that the

daily average of monitored parameter

values is outside the parameter range

established pursuant to § 63.152(b)(2),

or such that the monitoring data show

operation inconsistent with the

monitoring plan established pursuant to

§ 63.120(d)(2) or § 63.181(g)(1)(iv), shall

constitute a violation of the required

operating conditions.

* * * * *

Table 1 of Subpart F [Amended]

4. Table 1 of subpart F is amended by

removing the entry for acetaldol and its

associated CAS number and group

number.

[FR Doc. 98–12579 Filed 5–11–98; 8:45 am]

BILLING CODE 6560–50–P

ENVIRONMENTAL PROTECTION

AGENCY

40 CFR Part 180

[OPP–300648; FRL–5787–8]

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 cucurbits and

watercress . This action is in response

to EPA’s granting of an emergency

exemption under section 18 of the

Federal Insecticide, Fungicide, and

Rodenticide Act (FIFRA) authorizing

use of the pesticide on cucurbits and

watercress in several states. This

regulation establishes a maximum

permissible level for residues of

azoxystrobin in this food commodity

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

Federal Food, Drug, and Cosmetic Act

(FFDCA), as amended by the Food

Quality Protection Act (FQPA) of 1996.
Federal Register / Vol. 63, No. 91 /Tuesday, May 12, 1998 /Rules and Regulations 26083

The tolerance will expire and is revoked

on June 30, 1999.

DATES: This regulation is effective May

12, 1998. Objections and requests for

hearings must be received by EPA on or

before July 13, 1998.

ADDRESSES: Written objections and

hearing requests, identified by the

docket control number, [OPP–300648],

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–

300648], 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 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–

300648]. 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 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 cucurbits and watercress at 1.0

and 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 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 FIFRA, 7 U.S.C. 136 et seq.

The FQPA amendments went into effect

immediately. Among other things,

FQPA amends FFDCA to bring all EPA

pesticide tolerance-setting activities

under a new section 408 with a new

safety standard and new procedures.

These activities are described below and

discussed in greater detail in the final

rule establishing the time-limited

tolerance associated with the emergency

exemption for use of propiconazole on

sorghum (61 FR 58135, November 13,

1996)(FRL–5572–9).

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

FFDCA allows EPA to establish a

tolerance (the legal limit for a pesticide

chemical residue in or on a food) only

if EPA determines that the tolerance is

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

‘‘safe’’ to mean that ‘‘there is a

reasonable certainty that no harm will

result from aggregate exposure to the

pesticide chemical residue, including

all anticipated dietary exposures and all

other exposures for which there is

reliable information.’’ This includes

exposure through drinking water and in

residential settings, but does not include

occupational exposure. Section

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

consideration to exposure of infants and

children to the pesticide chemical

residue in establishing a tolerance and

to ‘‘ensure that there is a reasonable

certainty that no harm will result to

infants and children from aggregate

exposure to the pesticide chemical

residue. . . .’’

Section 18 of FIFRA authorizes EPA

to exempt any Federal or State agency

from any provision of FIFRA, if EPA

determines that ‘‘emergency conditions

exist which require such exemption.’’

This provision was not amended by

FQPA. EPA has established regulations

governing such emergency exemptions

in 40 CFR part 166.

Section 408(l)(6) of the FFDCA

requires EPA to establish a time-limited

tolerance or exemption from the

requirement for a tolerance for pesticide

chemical residues in food that will

result from the use of a pesticide under

an emergency exemption granted by

EPA under section 18 of FIFRA. Such

tolerances can be established without

providing notice or period for public

comment.

Because decisions on section 18-

related tolerances must proceed before

EPA reaches closure on several policy

issues relating to interpretation and

implementation of the FQPA, EPA does

not intend for its actions on such

tolerance to set binding precedents for

the application of section 408 and the

new safety standard to other tolerances

and exemptions.

II. Emergency Exemption for

Azoxystrobin on Cucurbits and

Watercress and FFDCA Tolerances

For watercress, copper hydroxide is

the only material registered for control

of Cercospora leaf spot disease. Several

applications of copper hydroxide are

required per season for adequate

control. Although copper hydroxide is

still effective at controlling Cercospora

leaf spot disease, due to the many

required applications, levels of copper

in soil and watercress plants have

reached phytotoxic levels. As a

consequence, in areas where watercress

has been grown for several years, yield

has been significantly reduced.

For cucurbits, azoxystrobin has been

requested for the control of gummy stem

blight and powdery mildew because

unusually wet and cloudy weather

conditions favor disease development.

Similar weather conditions in 1997

resulted in estimated production losses

of 68.4 and 36.2% in cantaloupe and

honeydews. Registered alternatives are

ineffective due to a combination of

weather and resistance factors.

EPA has authorized under FIFRA

section 18 the use of azoxystrobin on

cucurbits and watercress for control of

gummy stem blight on cucurbits and

Cercospora leaf spot disease in

watercress in several States. After

having reviewed the submission, EPA

concurs that emergency conditions exist

for these States.

As part of its assessment of this

emergency exemption, EPA assessed the

potential risks presented by residues of

azoxystrobin in or on cucurbits and

watercress. 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
26084 Federal Register / Vol. 63, No. 91 /Tuesday, May 12, 1998 /Rules and Regulations

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 cucurbits

and watercress 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

cucurbits and watercress 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 the approved States 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

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
Federal Register / Vol. 63, No. 91 /Tuesday, May 12, 1998 /Rules and Regulations 26085

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 (<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 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 cucurbits and watercress at

1.0 and 1.0 ppm. EPA’s assessment of

the dietary exposures and risks

associated with establishing the

tolerance follows.

A. Toxicological Profile

EPA has evaluated the available

toxicity data and considered its validity,

completeness, and reliability as well as

the relationship of the results of the

studies to human risk. EPA has also

considered available information

concerning the variability of the

sensitivities of major identifiable

subgroups of consumers, including

infants and children. The nature of the

toxic effects 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 mg/kg/day at

the highest dose tested (Acute

inhalation toxicity category III).

3. Chronic toxicity. EPA has

established the RfD for azoxystrobin at

0.18 milligrams/kilogram/day (mg/kg/

day). This RfD is based 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

cucurbits, watercress and all other

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 Sub-Group TMRC (mg/kg/

day) % RFD

U.S. Population (48 States) 0.002 1%
26086 Federal Register / Vol. 63, No. 91 /Tuesday, May 12, 1998 /Rules and Regulations

Population Sub-Group TMRC (mg/kg/

day) % RFD

Nursing Infants (<1 year old) 0.004 2%

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 preg 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

Table 1. Estimated environmental

concentrations (EECs) using GENEEC for

azoxystrobin on bananas, grapes,

peaches, peanuts, pecans, tomatoes, and

wheat are listed in SWAT Team Second

Interim Report (6/20/97). The highest

EEC for azoxystrobin in surface water is

from the application of azoxystrobin on

grapes (39 μg/L) and is substantially

lower than the DWLOCs calculated.

Therefore, chronic exposure to

azoxystrobin residues in drinking water

do not exceed the Agency’s level of

concern.

Table 1. 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 (μg/L)

U.S. Population (48 States) .............. 0.18 0.00231 0.178 6200

Females (13+ years old, not pregnant or nursing) ............................. 0.18 0.00176 0.178 5300

Non-nursing Infants (< 1 year old) ... 0.18 0.00879 0.171 1700

1 Maximum Water Exposure (mg/kg/day) = RfD (mg/kg/day) - TMRC from DRES (mg/kg/day) 2 DWLOC(μg/L) = Max water exposure (mg/kg/day) * body wt (kg) /[(10-3 mg/μg)*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.

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
Federal Register / Vol. 63, No. 91 /Tuesday, May 12, 1998 /Rules and Regulations 26087

common mechanism of toxicity with

other substances.

C. Aggregate Risks and Determination of

Safety for U.S. Population

1. 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.

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. 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— 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 2-generation

reproduction study in the rat. The

developmental toxicity studies are

designed to evaluate adverse effects on

the developing organism resulting from

maternal pesticide exposure during

gestation. Reproduction studies provide

information relating to effects from

exposure to the pesticide on the

reproductive capability of mating

animals and data on systemic toxicity.

FFDCA section 408 provides that EPA

shall apply an additional tenfold margin

of safety for infants and children in the

case of threshold effects to account for

pre-and post-natal toxicity and the

completeness of the database unless

EPA determines that a different margin

of safety will be safe for infants and

children. Margins of safety are

incorporated into EPA risk assessments

either directly through use of a MOE

analysis or through using uncertainty

(safety) factors in calculating a dose

level that poses no appreciable risk to

humans. EPA believes that reliable data

support using the standard MOE and

uncertainty factor (usually 100 for

combined inter- and intra-species

variability)) and not the additional

tenfold MOE/uncertainty factor when

EPA has a complete data base under

existing guidelines and when the

severity of the effect in infants or

children or the potency or unusual toxic

properties of a compound do not raise

concerns regarding the adequacy of the

standard MOE/safety factor.

2. Developmental toxicity studies—i.

Rabbit. In the developmental toxicity

study in rabbits, developmental NOEL

was 500 mg/kg/day, at the highest dose

tested (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.

ii. 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).

3. Reproductive toxicity study— i.

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.

ii. 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

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.

iii. 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.

4. 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

The nature of the residue in grapes is

adequately understood. The residue of

concern in grapes is parent azoxystrobin

and its Z isomer. The qualitative nature

of the residue in wheat is adequately

understood. Again, the major residues

are azoxystrobin and the Z isomer in

wheat metabolism studies. These data

are being translated for watercress for

this emergency exemption.

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 time-limited

tolerances for emergency exemptions

only, the residues of concern in animal

tissues are azoxystrobin and its Zisomer.
26088 Federal Register / Vol. 63, No. 91 /Tuesday, May 12, 1998 /Rules and Regulations

B. Analytical Enforcement Methodology

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.

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. The Agency 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 1.0

ppm in/on cucurbits or watercress as a

result of this Section 18 use. Timelimited tolerances should be established

at this level.

D. Rotational Crop Restrictions

Rotational crop data were previously

submitted. Based on this information, a

45 day plantback interval is appropriate

for all crops.

E. International Residue Limits

There are no CODEX, Canadian, or

Mexican Maximum Residue Limits

(MRL) for azoxystrobin on cucurbits or

watercress. Thus, harmonization is not

an issue for these section 18 requests.

VI. Conclusion

Therefore, the tolerance is established

for combined residues of azoxystrobin

and its Z isomer in cucurbits and

watercress at 1.0 and 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 July 13, 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 Docket

EPA has established a record for this

rulemaking under docket control

number [OPP–300648] (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 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
Federal Register / Vol. 63, No. 91 /Tuesday, May 12, 1998 /Rules and Regulations 26089

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

seq.) do not apply. Nevertheless, the

Agency has previously assessed whether

establishing tolerances, exemptions

from tolerances, raising tolerance levels

or expanding exemptions might

adversely impact small entities and

concluded, as a generic matter, that

there is no adverse economic impact.

The factual basis for the Agency’s

generic certification for tolerance

actions published on May 4, 1981 (46

FR 24950), and was provided to the

Chief Counsel for Advocacy of the Small

Business Administration.

X. Submission to Congress and the

Comptroller General

The Congressional Review Act, 5

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

Business Regulatory Enforcement

Fairness Act of 1996, generally provides

that before a rule may take effect, the

agency promulgating the rule must

submit a rule report, which includes a

copy of the rule, to each House of the

Congress and to the Comptroller General

of the United States. EPA will submit a

report containing this rule and other

required information to the U.S. Senate,

the U.S. House of Representatives, and

the Comptroller General of the United

States prior to publication of 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: April 27, 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

* * * * * * *

Cucurbits .............................................................................................. 1.0 6/30/99

* * * * * * *

Watercress ........................................................................................... 1.0 6/30/99

* * * * *

[FR Doc. 98–12578 Filed 5–11–98; 8:45 am]

BILLING CODE 6560–50–F

ENVIRONMENTAL PROTECTION

AGENCY

40 CFR Part 180

[OPP–300647; FRL–5787–7]

RIN 2070–AB78

Myclobutanil; Pesticide Tolerance.

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Final rule.

SUMMARY: This regulation establishes a

tolerance for the fungicide myclobutanil

[alpha-butyl-alpha-(4-chlorophenyl)-1H1,2,4-triazole-1-propanenitrile] and its

metabolite alpha-(3-hydroxybutyl)-

alpha-(4-chlorophenyl)-1H-1,2,4-

triazole-1-propanenitrile (free and

bound) in or on bananas (post-harvest).

Rohm and Haas Company requested this

tolerance under the Federal Food, Drug

and Cosmetic Act (FFDCA), as amended

by the Food Quality Protection Act of

1996 (FQPA) (Pub. L. 104-170).

DATES: This regulation is effective May

12, 1998. Objections and requests for

hearings must be received by EPA on or

before July 13, 1998.

ADDRESSES: Written objections and

hearing requests, identified by the

docket control number, [OPP–300647],

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–

300647], 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 or 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–

300647]. 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: Mary L. Waller, 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, Rm 247, 1921 Jefferson Davis

Hwy., Arlington, VA, (703) 308-9354, email: waller.mary@epamail.epa.gov.

SUPPLEMENTARY INFORMATION: In the

Federal Register of August 1, 1997 (62

FR 41379)(FRL–5732–4), EPA, issued a

notice pursuant to section 408 of the

Federal Food, Drug, and Cosmetic Act

(FFDCA), 21 U.S.C. 346a(e) announcing

the filing of pesticide petition (PP)

2E4141 for a tolerance by Rohm and

Haas Company, 100 Independence Mall