42684 Federal Register / Vol. 62, No. 153 / Friday, August 8, 1997 / Rules and Regulations

In addition, since these tolerances and

exemptions that are established on the

basis of a petition under FFDCA section

408 (d), 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: July 24, 1997.

James Jones,

Acting Director, Registration Division, Office

of Pesticide Programs.

Therefore, 40 CFR chapter I is

amended as follows:

PART 180—[AMENDED]

1. The authority citation for part 180

continues to read as follows:

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

2. Section 180.509 is added to read as

follows :

§ 180.509 HOE–107892 (mefenpyr-diethyl);

tolerance for residues.

(a) General. [Reserved]

(b) Section 18 emergency exemptions.

Time-limited tolerances are established

for residues of the herbicide safener

HOE–107892 (mefenpyr-diethyl) and its

2,4-dichlorophenyl-pyrazoline

metabolites HOE–094270 and HOE–

113225 in connection with use of the

herbicide safener under Section 18

emergency exemptions granted by the

EPA. The tolerances will expire and are

revoked on the dates specified in the

following table:

Commodity Parts per million Expiration/revocation date

Wheat grain ......................................................................................... 0.01 August 1, 1998

Wheat straw ......................................................................................... 0.05 August 1, 1998

(c) Tolerances with regional

registrations. [Reserved]

(d) Indirect or inadvertent residues.

[Reserved]

[FR Doc. 97–20844 Filed 8-7-97; 8:45 am]

BILLING CODE 6560–50–F

ENVIRONMENTAL PROTECTION

AGENCY

40 CFR Part 180

[OPP–300522 FRL–5732–9]

RIN 2070–AB78

Myclobutanil; Pesticide Tolerances for

Emergency Exemptions

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Final rule.

SUMMARY: This regulation establishes

time-limited tolerances for combined

residues of myclobutanil in or on

tomatoes . 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 tomatoes. This regulation

establishes a maximum permissible

level for residues of myclobutanil 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

July 28, 1998.

DATES: This regulation is effective

August 8, 1997. Objections and requests

for hearings must be received by EPA on

or before October 7, 1997.

ADDRESSES: Written objections and

hearing requests, identified by the

docket control number, [OPP–300522],

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–

300522], must also be submitted to:

Public Information and Records

Integrity Branch, Information Resources

and Services Division (7506C), Office of

Pesticide Programs, Environmental

Protection Agency, 401 M St., SW.,

Washington, DC 20460. In person, bring

a copy of objections and hearing

requests to Rm. 1132, CM #2, 1921

Jefferson Davis Hwy., Arlington, VA.

A copy of objections and hearing

requests filed with the Hearing Clerk

may also be submitted electronically by

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

objections and hearing requests must be

submitted as an ASCII file avoiding the

use of special characters and any form

of encryption. Copies of objections and

hearing requests will also be accepted

on disks in WordPerfect 5.1 file format

or ASCII file format. All copies of

objections and hearing requests in

electronic form must be identified by

the docket control number [OPP300522]. No Confidential Business

Information (CBI) should be submitted

through e-mail. Electronic copies of

objections and hearing requests on this

rule may be filed online at many Federal

Depository Libraries.

FOR FURTHER INFORMATION CONTACT: By

mail: Andrew Ertman, Registration

Division 7505C, Office of Pesticide

Programs, Environmental Protection

Agency, 401 M St., SW., Washington,

DC 20460. Office location, telephone

number, and e-mail address: Crystal

Mall #2, 1921 Jefferson Davis Hwy.,

Arlington, VA, (703) 308-9367, e-mail:

ertman.andrew@epamail.epa.gov.
Federal Register / Vol. 62, No. 153 / Friday, August 8, 1997 / Rules and Regulations 42685

SUPPLEMENTARY INFORMATION: EPA, on

its own initiative, pursuant to section

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

Drug, and Cosmetic Act (FFDCA), 21

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

tolerances for combined residues of the

fungicide myclobutanil, in or on tomato

fruit at 0.3 part per million (ppm),

tomato puree at 0.6 ppm and tomato

paste at 1.2 ppm. These tolerances will

expire and are revoked on July 28, 1998.

EPA will publish a document in the

Federal Register to remove the revoked

tolerances from the Code of Federal

Regulations.

I. Background and Statutory Authority

The Food Quality Protection Act of

1996 (FQPA) (Pub. L. 104–170) was

signed into law August 3, 1996. FQPA

amends both the Federal Food, Drug,

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

301 et seq., and the Federal Insecticide,

Fungicide, and Rodenticide Act

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

amendments went into effect

immediately. Among other things,

FQPA amends FFDCA to bring all EPA

pesticide tolerance-setting activities

under a new section 408 with a new

safety standard and new procedures.

These activities are described below and

discussed in greater detail in the final

rule establishing the time-limited

tolerance associated with the emergency

exemption for use of propiconazole on

sorghum (61 FR 58135, November 13,

1996)(FRL–5572–9).

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

FFDCA allows EPA to establish a

tolerance (the legal limit for a pesticide

chemical residue in or on a food) only

if EPA determines that the tolerance is

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

‘‘safe’’ to mean that ‘‘there is a

reasonable certainty that no harm will

result from aggregate exposure to the

pesticide chemical residue, including

all anticipated dietary exposures and all

other exposures for which there is

reliable information.’’ This includes

exposure through drinking water and in

residential settings, but does not include

occupational exposure. Section

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

consideration to exposure of infants and

children to the pesticide chemical

residue in establishing a tolerance and

to ‘‘ensure that there is a reasonable

certainty that no harm will result to

infants and children from aggregate

exposure to the pesticide chemical

residue. . . .’’

Section 18 of FIFRA authorizes EPA

to exempt any Federal or State agency

from any provision of FIFRA, if EPA

determines that ‘‘emergency conditions

exist which require such exemption.’’

This provision was not amended by

FQPA. EPA has established regulations

governing such emergency exemptions

in 40 CFR part 166.

Section 408(l)(6) of the FFDCA

requires EPA to establish a time-limited

tolerance or exemption from the

requirement for a tolerance for pesticide

chemical residues in food that will

result from the use of a pesticide under

an emergency exemption granted by

EPA under section 18 of FIFRA. Such

tolerances can be established without

providing notice or period for public

comment.

Because decisions on section 18-

related tolerances must proceed before

EPA reaches closure on several policy

issues relating to interpretation and

implementation of the FQPA, EPA does

not intend for its actions on such

tolerance to set binding precedents for

the application of section 408 and the

new safety standard to other tolerances

and exemptions.

II. Emergency Exemption for

Myclobutanil on Tomatoes and FFDCA

Tolerances

The state of California requested a

specific exemption for the use of

myclobutanil on tomatoes to control

powdery mildew (Leveillula taurica).

Powdery mildew is a pathogen that was

first identified as a problem on tomatoes

in California in 1978. The applicant

states that powdery mildew is endemic

and well established throughout

California and without the use of

myclobutanil growers could incur

severe economic damage to their crops.

EPA has authorized under FIFRA

section 18 the use of myclobutanil on

tomatoes for control of powdery mildew

in California. After having reviewed the

submission, EPA concurs that

emergency conditions exist for this

state.

As part of its assessment of this

emergency exemption, EPA assessed the

potential risks presented by residues of

myclobutanil in or on tomatoes. 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 July 28, 1998,

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

of the pesticide not in excess of the

amounts specified in the tolerance

remaining in or on tomatoes after that

date will not be unlawful, provided the

pesticide is applied in a manner that

was lawful under FIFRA. EPA will take

action to revoke this tolerance earlier if

any experience with, scientific data on,

or other relevant information on this

pesticide indicate that the residues are

not safe.

Because these tolerances are being

approved under emergency conditions

EPA has not made any decisions about

whether myclobutanil meets EPA’s

registration requirements for use on

tomatoes or whether permanent

tolerances for this use would be

appropriate. Under these circumstances,

EPA does not believe that these

tolerances serve as a basis for

registration of myclobutanil by a state

for special local needs under FIFRA

section 24(c). Nor do these tolerances

serve as the basis for any state other

than California 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

myclobutanil, contact the Agency’s

Registration Division at the address

provided above.

III. Risk Assessment and Statutory

Findings

EPA performs a number of analyses to

determine the risks from aggregate

exposure to pesticide residues. First,

EPA determines the toxicity of

pesticides based primarily on

toxicological studies using laboratory

animals. These studies address many

adverse health effects, including (but

not limited to) reproductive effects,

developmental toxicity, toxicity to the

nervous system, and carcinogenicity.

Second, EPA examines exposure to the

pesticide through the diet (e.g., food and

drinking water) and through exposures

that occur as a result of pesticide use in

residential settings.

A. Toxicity

1. Threshold and non-threshold

effects. For many animal studies, a dose

response relationship can be

determined, which provides a dose that

causes adverse effects (threshold effects)

and doses causing no observed effects

(the ‘‘no-observed effect level’’ or

‘‘NOEL’’).

Once a study has been evaluated and

the observed effects have been

determined to be threshold effects, EPA

generally divides the NOEL from the

study with the lowest NOEL by an

uncertainty factor (usually 100 or more)

to determine the Reference Dose (RfD).
42686 Federal Register / Vol. 62, No. 153 / Friday, August 8, 1997 / Rules and Regulations

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 3 sources

are not typically added because of the

very low probability of this occurring in

most cases, and because the other

conservative assumptions built into the

assessment assure adequate protection

of public health. However, for cases in

which high-end exposure can

reasonably be expected from multiple

sources (e.g. frequent and widespread

homeowner use in a specific

geographical area), multiple high-end

risks will be aggregated and presented

as part of the comprehensive risk

assessment/characterization. Since the

toxicological endpoint considered in

this assessment reflects exposure over a

period of at least 7 days, an additional

degree of conservatism is built into the

assessment; i.e., the risk assessment

nominally covers 1-7 days exposure,

and the toxicological endpoint/NOEL is

selected to be adequate for at least 7

days of exposure. (Toxicity results at

lower levels when the dosing duration

is increased.)

Intermediate-term risk results from

exposure for 7 days to several months.

This assessment is handled in a manner

similar to the short-term risk

assessment.

Chronic risk assessment describes risk

which could result from several months

to a lifetime of exposure. For this

assessment, risks are aggregated

considering average exposure from all

sources for representative population

subgroups including infants and

children.

B. Aggregate Exposure

In examining aggregate exposure,

FFDCA section 408 requires that EPA

take into account available and reliable

information concerning exposure from

the pesticide residue in the food in

question, residues in other foods for

which there are tolerances, residues in

groundwater or surface water that is

consumed as drinking water, and other

non-occupational exposures through

pesticide use in gardens, lawns, or

buildings (residential and other indoor

uses). Dietary exposure to residues of a

pesticide in a food commodity are

estimated by multiplying the average

daily consumption of the food forms of

that commodity by the tolerance level or

the anticipated pesticide residue level.

The Theoretical Maximum Residue

Contribution (TMRC) is an estimate of

the level of residues consumed daily if

each food item contained pesticide

residues equal to the tolerance. In

evaluating food exposures, EPA takes

into account varying consumption

patterns of major identifiable subgroups

of consumers, including infants and

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

estimate since it is based on the

assumptions that food contains

pesticide residues at the tolerance level

and that 100% of the crop is treated by

pesticides that have established

tolerances. If the TMRC exceeds the RfD

or poses a lifetime cancer risk that is

greater than approximately one in a

million, EPA attempts to derive a more

accurate exposure estimate for the

pesticide by evaluating additional types

of information (anticipated residue data

and/or percent of crop treated data)

which show, generally, that pesticide

residues in most foods when they are

eaten are well below established

tolerances.

Percent of crop treated estimates are

derived from federal and private market

survey data. Typically, a range of

estimates are supplied and the upper

end of this range is assumed for the

exposure assessment. By using this

upper end estimate of percent of crop

treated, the Agency is reasonably certain

that exposure is not understated for any

significant subpopulation group.

Further, regional consumption

information is taken into account

through EPA’s computer-based model

for evaluating the exposure of

significant subpopulations including

several regional groups, to pesticide

residues. For this pesticide, the most

highly exposed population subgroup

(non-nursing infants <1 year old) was

not regionally based.

IV. Aggregate Risk Assessment and

Determination of Safety

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

EPA has reviewed the available

scientific data and other relevant

information in support of this action,
Federal Register / Vol. 62, No. 153 / Friday, August 8, 1997 / Rules and Regulations 42687

EPA has sufficient data to assess the

hazards of myclobutanil and to make a

determination on aggregate exposure,

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

time-limited tolerances for combined

residues of myclobutanil in or on

tomato fruit at 0.3 ppm, tomato puree at

0.6 ppm and tomato paste at 1.2 ppm.

EPA’s assessment of the dietary

exposures and risks associated with

establishing the tolerances follows.

A. Toxicological Profile

EPA has evaluated the available

toxicity data and considered its validity,

completeness, and reliability as well as

the relationship of the results of the

studies to human risk. EPA has also

considered available information

concerning the variability of the

sensitivities of major identifiable

subgroups of consumers, including

infants and children. The nature of the

toxic effects caused by myclobutanil are

discussed below.

1. Short - and intermediate - term

toxicity. For short-term dermal Margin

of Exposure (MOE) calculations, the

Agency used the systemic NOEL of 100

mg/kg/day from a 21-day dermal

toxicity study in rats. This dose was the

highest tested in the study. The Agency

did not identify an inhalation endpoint.

For intermediate-term MOE

calculations, the Agency used the NOEL

of 10 mg/kg/day from a 2-generation

reproductive toxicity study in rats. At

the lowest effect level (LEL) of 50 mg/

kg/day, there were decreases in pup

body weight, an increased incidence in

the number of stillborns, and atrophy of

the prostate and testes.

2. Chronic toxicity. EPA has

established the RfD for myclobutanil at

0.025 mg/kg/day milligrams/kilogram/

day (mg/kg/day). This RfD is based on

a chronic feeding study in rats using a

NOEL of 2.5 mg/kg/day and an

uncertainty factor of 100. At the lowest

observed effect level (LOEL) of 9.9 mg/

kg/day there was testicular atrophy.

3. Carcinogenicity. Myclobutanil has

been classified as a Group E chemical

(no evidence of carcinogenicity for

humans) by the Agency.

B. Exposures and Risks

1. From food and feed uses.

Tolerances have been established (40

CFR 180.443) for the combined residues

of myclobutanil [α-butyl-α-(4-

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

propanenitrile] plus its alcohol

metabolite [α-(3-hydroxybutyl)-α-(4-

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

propanenitrile] (free and bound), in or

on a variety of raw agricultural

commodities at levels ranging from 5.0

ppm in cherries to 0.02 ppm in eggs. A

tolerance has also been established (40

CFR 180.443(b)) for the combined

residues of myclobutanil plus its

alcohol metabolite (free and bound) and

diol metabolite [α-(4-chlorophenyl)-α-

(3,4-dihydroxybutyl)-1H-1,2,4-triazole1-propanenitrile], in milk at 0.05 ppm.

Risk assessments were conducted by

EPA to assess dietary exposures and

risks from myclobutanil as follows:

Chronic exposure and risk. In

conducting this chronic dietary risk

assessment, EPA has made somewhat

conservative assumptions -- with the

exception of bananas, all commodities

having myclobutanil tolerances will

contain myclobutanil and metabolite

residues and those residues will be at

the level of the established tolerance --

which results in an overestimate of

human dietary exposure. For bananas an

anticipated residue estimate was used.

Percent crop-treated estimates were

utilized for selected commodities

included in the assessment. Thus, in

making a safety determination for this

tolerance, EPA is taking into account

this partially refined exposure

assessment.

The existing myclobutanil tolerances

(published, pending, and including the

necessary Section 18 tolerances) result

in an Anticipated Residue Contribution

(ARC) that is equivalent to the following

percentages of the RfD:

Population Subgroup

ARCfood

(mg/kg/

day)

%RfD

U.S. population (48

states).

0.004255 17%

Nursing infants (<1

year old).

0.006359 25%

Non-Nursing Infants

(<1 year old).

0.018836 75%

Children (1-6 years

old).

0.011492 46%

Children (7-12 years

old).

0.006910 28%

Northeast Region .... 0.004539 18%

Western Region ...... 0.004848 19%

Hispanics ................ 0.005049 20%

Non-Hispanic Others.0.004425 18%

The subgroups listed above are: (1)

the U.S. population (48 states); (2) those

for infants and children; and, (3) 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. Myclobutanil

is persistent and not considered mobile

in soils with the exception of sandy

soils. Data are not available for its diol

metabolite. There is no established

Maximum Contaminant Level for

residues of myclobutanil in drinking

water. No Health Advisory Levels for

myclobutanil in drinking water have

been established.

Chronic exposure and risk. Because

the Agency lacks sufficient waterrelated exposure data to complete a

comprehensive drinking water risk

assessment for many pesticides, EPA

has commenced and nearly completed a

process to identify a reasonable yet

conservative bounding figure for the

potential contribution of water-related

exposure to the aggregate risk posed by

a pesticide. In developing the bounding

figure, EPA estimated residue levels in

water for a number of specific pesticides

using various data sources. The Agency

then applied the estimated residue

levels, in conjunction with appropriate

toxicological endpoints (RfD’s or acute

dietary NOEL’s) and assumptions about

body weight and consumption, to

calculate, for each pesticide, the

increment of aggregate risk contributed

by consumption of contaminated water.

While EPA has not yet pinpointed the

appropriate bounding figure for

exposure from contaminated water, the

ranges the Agency is continuing to

examine are all below the level that

would cause myclobutanil to exceed the

RfD if the tolerance being considered in

this document were granted. The

Agency has therefore concluded that the

potential exposures associated with

myclobutanil in water, even at the

higher levels the Agency is considering

as a conservative upper bound, would

not prevent the Agency from

determining that there is a reasonable

certainty of no harm if the tolerance is

granted.

3. From non-dietary exposure.

Myclobutanil is currently registered for

use on the following residential nonfood sites: outdoor residential and

greenhouse use on annuals and

perennials, turf, shrubs, trees, flowers.

These uses do not constitute a chronic

exposure scenario, but may constitute a

short- to intermediate-term exposure

scenario. However, EPA lacks sufficient

residential-related exposure data to

complete a comprehensive residential

risk assessment for many pesticides,

including myclobutanil.

4. Cumulative exposure to substances

with common mechanism of toxicity.

Section 408(b)(2)(D)(v) requires that,

when considering whether to establish,

modify, or revoke a tolerance, the

Agency consider ‘‘available

information’’ concerning the cumulative

effects of a particular pesticide’s

residues and ‘‘other substances that

have a common mechanism of toxicity.’’

The Agency believes that ‘‘available

information’’ in this context might
42688 Federal Register / Vol. 62, No. 153 / Friday, August 8, 1997 / Rules and Regulations

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

myclobutanil has a common mechanism

of toxicity with other substances or how

to include this pesticide in a cumulative

risk assessment. Unlike other pesticides

for which EPA has followed a

cumulative risk approach based on a

common mechanism of toxicity,

myclobutanil does not appear to

produce a toxic metabolite produced by

other substances. For the purposes of

this tolerance action, therefore, EPA has

not assumed that myclobutanil has a

common mechanism of toxicity with

other substances.

C. Aggregate Risks and Determination of

Safety for U.S. Population

1. Chronic risk. Using the partially

refined exposure assumptions described

above under ‘‘Chronic Exposure and

Risk’’ and taking into account the

completeness and reliability of the

toxicity data, EPA has concluded that

aggregate dietary exposure (food only) to

myclobutanil will utilize 17% of the

RfD for the U.S. population. EPA

generally has no concern for exposures

below 100% of the RfD because the RfD

represents the level at or below which

daily aggregate dietary exposure over a

lifetime will not pose appreciable risks

to human health. EPA has determined

that the outdoor registered uses of

myclobutanil would not fall under a

chronic exposure scenario. Despite the

potential for exposure to myclobutanil

in drinking water, using best scientific

judgement EPA does not expect the

aggregate exposure of food and water to

exceed 100% of the RfD. The Agency

concludes that there is a reasonable

certainty that no harm will result from

aggregate chronic exposure to

myclobutanil residues.

2. Short- and intermediate-term risk.

Short- and intermediate-term aggregate

exposure takes into account chronic

dietary food and water (considered to be

a background exposure level) plus

indoor and outdoor residential

exposure. Although short-term exposure

scenarios may be present, based on the

lack of acute toxicological endpoints

and the low percent of RfD occupied, in

the best scientific judgement of the

Agency, aggregate short- and

intermediate-term risk will not exceed

EPA’s level of concern. Additionally,

the Agency notes that there are no

indoor residential uses of myclobutanil,

thus indoor residential exposure is

expected to be minimal.

D. Aggregate Cancer Risk for U.S.

Population

Myclobutanil was classified by the

Agency as a Group E chemical (no

evidence of carcinogenicity for

humans). Thus, a cancer risk assessment

was not conducted.

E. Aggregate Risks and Determination of

Safety for Infants and Children

1. Safety factor for infants and

children— a. In general. In assessing the

potential for additional sensitivity of

infants and children to residues of

myclobutanil, EPA considered data from

developmental toxicity studies in the rat

and rabbit and a two-generation

reproduction study in the rat. The

developmental toxicity studies are

designed to evaluate adverse effects on

the developing organism resulting from

pesticide exposure during prenatal

development to one or both parents.

Reproduction studies provide

information relating to effects from

exposure to the pesticide on the

reproductive capability of mating

animals and data on systemic toxicity.

FFDCA section 408 provides that EPA

shall apply an additional tenfold margin

of safety for infants and children in the

case of threshold effects to account for

pre-and post-natal toxicity and the

completeness of the database unless

EPA determines that a different margin

of safety will be safe for infants and

children. Margins of safety are

incorporated into EPA risk assessments

either directly through use of a MOE

analysis or through using uncertainty

(safety) factors in calculating a dose

level that poses no appreciable risk to

humans. EPA believes that reliable data

support using the standard MOE and

uncertainty factor (usually 100 for

combined inter- and intra-species

variability) and not the additional

tenfold MOE/uncertainty factor when

EPA has a complete data base under

existing guidelines and when the

severity of the effect in infants or

children or the potency or unusual toxic

properties of a compound do not raise

concerns regarding the adequacy of the

standard MOE/safety factor.

b. Developmental toxicity studies. In

the developmental study in rats, the

maternal (systemic) NOEL was 93.8 mg/

kg/day, based on rough hair coat, and

salivation at the LOEL of 312.6 mg/kg/

day. The developmental (fetal) NOEL

was 93.8 mg/kg/day based on

incidences of 14th rudimentary and 7th

cervical ribs at the LOEL of 312.6 mg/

kg/day.

In the developmental toxicity study in

rabbits, the maternal (systemic) NOEL

was 60 mg/kg/day, based on reduced

weight gain, clinical signs of toxicity

and abortions at the LOEL of 200 mg/

kg/day. The developmental (fetal) NOEL

was 60 mg/kg/day, based on increases in

number of resorptions, decreases in

litter size, and a decrease in the viability

index at the LOEL of 200 mg/kg/day.

c. Reproductive toxicity study. In the

2-generation reproductive toxicity study

in rats, the parental (systemic) NOEL

was 2.5 mg/kg/day, based on increased

liver weights and liver cell hypertrophy

at the LOEL of 10 mg/kg/day. The

developmental (pup) NOEL was 10 mg/

kg/day, based on decreased pup body

weight during lactation at the LOEL of

50 mg/kg/day. The reproductive (pup)

NOEL was 10 mg/kg/day, based on the

increased incidence of stillborns, and

atrophy of the testes, epididymides, and

prostate at the LEL of 50 mg/kg/day.
Federal Register / Vol. 62, No. 153 / Friday, August 8, 1997 / Rules and Regulations 42689

d. Pre- and post-natal sensitivity. The

pre- and post-natal toxicology data base

for myclobutanil is complete with

respect to current toxicological data

requirements. Based on the

developmental and reproductive

toxicity studies discussed above, for

myclobutanil there does not appear to

be an extra sensitivity for pre- or postnatal effects.

e. Conclusion. Based on the above,

EPA concludes that reliable data

support use of the standard 100-fold

uncertainty factor and that an additional

factor is not needed to protect the safety

of infants and children.

2. Chronic risk. Using the

conservative exposure assumptions

described above, EPA has concluded

that aggregate exposure to myclobutanil

from food ranges from 25% of the RfD

for nursing infants (<1 year old), up to

75% for non-nursing infants (<1 year

old). 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

myclobutanil in drinking water and

from non-dietary, non-occupational

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 myclobutanil

residues.

V. Other Considerations

A. Metabolism In Plants and Animals

The nature of the residue in plants is

adequately understood. The residue of

concern is myclobutanil plus its alcohol

metabolite (free and bound), as specified

in 40 CFR 180.443(a) .

B. Analytical Enforcement Methodology

An adequate enforcement method is

available to enforce the established

tolerances. Quantitation is by GLC using

an Nitrogen/Phosphorus detector for

myclobutanil and an Electron Capture

detector (Ni63) for residues measured as

the alcohol metabolite available in PAM

II or from the Agency.

C. Magnitude of Residues

Residues of myclobutanil and its

alcohol metabolite are not expected to

exceed 0.3 ppm in or on tomato fruit,

0.6 ppm in tomato puree or 1.2 ppm in

tomato paste as a result of this Section

18 use. Secondary residues are not

expected in animal commodities as no

feedstuffs are associated with this

Section 18 use. Meat/milk/poultry/egg

tolerances have been established as a

result of other myclobutanil uses.

D. International Residue Limits

There are no Codex, Canadian or

Mexican residue limits established for

myclobutanil and its metabolites on the

commodities included in these Section

18 requests. Thus, harmonization is not

an issue for these Section 18 actions.

E. Rotational Crop Restrictions

Information concerning the likelihood

of residues in rotational crops is not

available for myclobutanil. As tomato

fields are normally rotated, the Agency

concludes the following restriction

should be added to the label for the

requested Section 18: Rally treated

fields can be rotated at any time to crops

which are included on the Rally label.

All other crops may be planted 1 year

following applications of Rally

Agricultural Fungicide.

VI. Conclusion

Therefore, the tolerance is established

for combined residues of myclobutanil

in or on tomato fruit at 0.3 ppm, tomato

puree at 0.6 ppm and tomato paste at 1.2

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 October 7, 1997,

file written objections to any aspect of

this regulation and may also request a

hearing on those objections. Objections

and hearing requests must be filed with

the Hearing Clerk, at the address given

above (40 CFR 178.20). A copy of the

objections and/or hearing requests filed

with the Hearing Clerk should be

submitted to the OPP docket for this

rulemaking. The objections submitted

must specify the provisions of the

regulation deemed objectionable and the

grounds for the objections (40 CFR

178.25). Each objection must be

accompanied by the fee prescribed by

40 CFR 180.33(i). If a hearing is

requested, the objections must include a

statement of the factual issues on which

a hearing is requested, the requestor’s

contentions on such issues, and a

summary of any evidence relied upon

by the requestor (40 CFR 178.27). A

request for a hearing will be granted if

the Administrator determines that the

material submitted shows the following:

There is genuine and substantial issue

of fact; there is a reasonable possibility

that available evidence identified by the

requestor would, if established, resolve

one or more of such issues in favor of

the requestor, taking into account

uncontested claims or facts to the

contrary; and resolution of the factual

issues in the manner sought by the

requestor would be adequate to justify

the action requested (40 CFR 178.32).

Information submitted in connection

with an objection or hearing request

may be claimed confidential by marking

any part or all of that information as

Confidential Business Information (CBI).

Information so marked will not be

disclosed except in accordance with

procedures set forth in 40 CFR part 2.

A copy of the information that does not

contain CBI must be submitted for

inclusion in the public record.

Information not marked confidential

may be disclosed publicly by EPA

without prior notice.

VIII. Public Docket

EPA has established a record for this

rulemaking under docket control

number [OPP–300522] (including any

comments and data submitted

electronically). A public version of this

record, including printed, paper

versions of electronic comments, which

does not include any information

claimed as CBI, is available for

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

Monday through Friday, excluding legal

holidays. The public record is located in

Room 1132 of the Public Information

and Records Integrity Branch,

Information Resources and Services

Division (7506C), Office of Pesticide

Programs, Environmental Protection

Agency, Crystal Mall #2, 1921 Jefferson

Davis Hwy., Arlington, VA.

Electronic comments may be sent

directly to EPA at:

opp-docket@epamail.epa.gov.

Electronic comments must be

submitted as an ASCII file avoiding the

use of special characters and any form

of encryption.

The official record for this

rulemaking, as well as the public

version, as described above will be kept

in paper form. Accordingly, EPA will

transfer any copies of objections and

hearing requests received electronically

into printed, paper form as they are
42690 Federal Register / Vol. 62, No. 153 / Friday, August 8, 1997 / Rules and Regulations

received and will place the paper copies

in the official rulemaking record which

will also include all comments

submitted directly in writing. The

official rulemaking record is the paper

record maintained at the Virginia

address in ‘‘ADDRESSES’’ at the

beginning of this document.

IX. Regulatory Assessment

Requirements

This final rule establishes tolerances

under FFDCA section 408(d). The Office

of Management and Budget (OMB) has

exempted these types of actions from

review under Executive Order 12866,

entitled Regulatory Planning and

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

This final rule does not contain any

information collections subject to OMB

approval under the Paperwork

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

seq., or impose any enforceable duty or

contain any unfunded mandate as

described under Title II of the Unfunded

Mandates Reform Act of 1995 (UMRA)

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

prior consultation as specified by

Executive Order 12875, entitled

Enhancing the Intergovernmental

Partnership (58 FR 58093, October 28,

1993), or special considerations as

required by Executive Order 12898,

entitled Federal Actions to Address

Environmental Justice in Minority

Populations and Low-Income

Populations (59 FR 7629, February 16,

1994), or require OMB review in

accordance with Executive Order 13045,

entitled Protection of Children from

Environmental Health Risks and Safety

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

In addition, since these tolerances and

exemptions that are established under

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

tolerances in this final rule, do not

require the issuance of a proposed rule,

the requirements of the Regulatory

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

seq.) do not apply. Nevertheless, the

Agency has previously assessed whether

establishing tolerances, exemptions

from tolerances, raising tolerance levels

or expanding exemptions might

adversely impact small entities and

concluded, as a generic matter, that

there is no adverse economic impact.

The factual basis for the Agency’s

generic certification for tolerance

actions published on May 4, 1981 (46

FR 24950), and was provided to the

Chief Counsel for Advocacy of the Small

Business Administration.

X. Submission to Congress and the

General Accounting Office

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

by the Small Business Regulatory

Enforcement Fairness Act of 1996, the

Agency has submitted a report

containing this rule and other required

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

House of Representatives, and the

Comptroller General of the General

Accounting Office prior to publication

of this rule in today’s Federal Register.

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

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

List of Subjects in 40 CFR Part 180

Environmental protection,

Administrative practice and procedure,

Agricultural commodities, Pesticides

and pests, Reporting and recordkeeping

requirements.

Dated: July 24, 1997.

James Jones,

Acting Director, Registration Division, Office

of Pesticide Programs.

Therefore, 40 CFR chapter I is

amended as follows:

PART 180—[AMENDED]

1. The authority citation for part 180

continues to read as follows:

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

2. In § 180.443, in paragraph (b), by

revising the introductory text and

alphabetically adding the following

commodities to the table to read as

follows:

§ 180.443 Myclobutanil; tolerances for

residues.

* * * *

*

(b) Section 18 emergency exemptions.

Time-limited tolerances are established

for residues of the fungicide

myclobutanil in connection with use of

the pesticide under section 18

emergency exemptions granted by EPA.

These tolerances will expire and are

revoked on the dates specified in the

following table.

Commodity Parts per million Expiration/Revocation Date

* * * * * * *

Tomato, fruit ........................................................................................ 0.3 July 28, 1998

Tomato, paste ...................................................................................... 1.2 July 28, 1998

Tomato, puree ..................................................................................... 0.6 July 28, 1998

* * * * * * *

* * * * *

[FR Doc. 97–20846 Filed 8-7-97; 8:45 am]

BILLING CODE 6560–50–F

ENVIRONMENTAL PROTECTION

AGENCY

40 CFR Part 721

[OPPTS–50626A; FRL–5735–4]

RIN 2070–AB27

Modification of Significant New Use

Rules for Certain Substances

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Final rule.

SUMMARY: EPA is modifying significant

new use rules (SNURs) for five

substances promulgated under section

5(a)(2) of the Toxic Substances Control

Act (TSCA) for certain chemical

substances based on new data. Based on

the data the Agency determined that the

SNURs should be modified.

DATES: This rule is effective September

8, 1997.

FOR FURTHER INFORMATION CONTACT:

Susan B. Hazen, Director,

Environmental Assistance Division

(7408), Office of Pollution Prevention

and Toxics, Environmental Protection

Agency, Rm. E–543B, 401 M St., SW.,

Washington, DC 20460, telephone: (202)