17730 Federal Register / Vol. 62, No. 70 / Friday, April 11, 1997 / Rules and Regulations

Commodity

Parts Per

Million

(ppm)

* * * * *

(b) Section 18 emergency exemptions.

[Reserved]

(c) Tolerances with regional

registrations. [Reserved]

(d) Indirect or inadvertent

residues. * * *

PART 185—[AMENDED]

2. In part 185:

a. The authority citation for part 185

continues to read.

Authority: 21 U.S.C. 346a and 348.

§ 185.3500 [Removed]

b. In § 185.3500 by transferring the

entries in the tables to paragraphs (a)(1),

(2), and (3), and alphabetically adding

them to the table in paragraph (a) of

§ 180.364, and by removing the

remainder of § 185.3500.

PART 186—[AMENDED]

3. In part 186:

a. The authority citation for part 185

continues to read.

Authority: 21 U.S.C. 342, 348 and 701.

§ 186.3500 [Removed]

b. In § 186.3500 by transferring the

entries in the tables to paragraphs (a)

and (b) and alphabetically adding them

to the table in paragraph (a) of

§ 180.364, and by removing the

remainder of § 186.3500.

[FR Doc. 97–9231 Filed 4–10–97; 8:45 am]

BILLING CODE 6560–50–F

ENVIRONMENTAL PROTECTION

AGENCY

40 CFR Parts 180, 185 and 186

[OPP–300466; FRL–5597–9]

RIN 2070–AC78

Myclobutanil; Pesticide Tolerances for

Emergency Exemptions

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Final rule.

SUMMARY: This regulation establishes a

time-limited tolerance for residues of

the fungicide myclobutanil in or on the

raw agricultural commodity

strawberries in connection with EPA’s

granting of an emergency exemption

under section 18 of the Federal

Insecticide, Fungicide, and Rodenticide

Act authorizing use of myclobutanil on

strawberries in Florida. This regulation

establishes a maximum permissible

level for residues of myclobutanil in this

food 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 be revoked by EPA on

March 31, 1998.

DATES: This regulation becomes

effective April 11, 1997. Objections and

requests for hearings must be received

by EPA on June 10, 1997.

ADDRESSES: Written objections and

hearing requests, identified by the

docket control number, [OPP ], 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

document control number, [OPP ],

should be submitted to: Public Response

and Program Resources Branch, Field

Operations 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 number [OPP ]. 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: Stephen Schaible, Registration

Division (7505W), Environmental

Protection Agency, 401 M St., SW.,

Washington, DC 20460. Office location,

telephone number, and e-mail address:

Sixth Floor, Crystal Station #1, 2800

Jefferson Davis Highway, Arlington, VA

22202. (703) 308–8337, e-mail:

schaible.stephen@epamail.epa.gov.

SUPPLEMENTARY INFORMATION: EPA,

pursuant to section 408(e) and (l)(6) of

the Federal Food, Drug, and Cosmetic

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

(l)(6), is establishing a tolerance for

residues of the fungicide myclobutanil

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

metabolite alpha-(3-hydroxybutyl)-

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

triazole-1-propanenitrile (free and

bound), hereafter referred to as

myclobutanil, in or on strawberries at

0.5 part per million (ppm). This

tolerance will expire and be revoked on

March 31, 1998.

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 CFR 58135, November 13,

1996)(FRL–5572–9).

New section 408(b)(2)(A)(i) 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, 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
Federal Register / Vol. 62, No. 70 / Friday, April 11, 1997 / Rules and Regulations 17731

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) 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. Section 408(l)(6)

also requires EPA to promulgate

regulations by August 3, 1997,

governing the establishment of

tolerances and exemptions under

section 408(l)(6) and requires that the

regulations be consistent with section

408(b)(2) and (c)(2) and FIFRA section

18.

Section 408(l)(6) allows EPA to

establish tolerances or exemptions from

the requirement for a tolerance, in

connection with EPA’s granting of

FIFRA section 18 emergency

exemptions, without providing notice or

a period for public comment. Thus,

consistent with the need to act

expeditiously on requests for emergency

exemptions under FIFRA, EPA can

establish such tolerances or exemptions

under the authority of section 408(e)

and (l)(6) without notice and comment

rulemaking.

In establishing section 18-related

tolerances and exemptions during this

interim period before EPA issues the

section 408(l)(6) procedural regulation

and before EPA makes its broad policy

decisions concerning the interpretation

and implementation of the new section

408, EPA does not intend to set

precedents for the application of section

408 and the new safety standard to other

tolerances and exemptions. Rather,

these early section 18 tolerance and

exemption decisions will be made on a

case-by-case basis and will not bind

EPA as it proceeds with further

rulemaking and policy development.

EPA intends to act on section 18-related

tolerances and exemptions that clearly

qualify under the new law.

II. Emergency Exemption for

Myclobutanil on Strawberries and

FFDCA Tolerances

On January 14, 1997 the state of

Florida availed itself of the authority to

declare the existence of a crisis situation

within the state, thereby authorizing use

under FIFRA section 18 of myclobutanil

on strawberries to control powdery

mildew (Sphaerotheca fuliginea).

Florida stated that emergency

conditions developed due to planting of

powdery mildew-infected transplants

purchased from Canadian suppliers and

the occurrence of weather conditions

conducive to disease development.

Florida claims that the registered

alternatives are either not efficacious or

are phytotoxic. Without the use of

myclobutanil, it is claimed that

strawberry growers will suffer severe

economic losses.

As part of its assessment of this crisis

declaration, EPA assessed the potential

risks presented by residues of

myclobutanil in or on strawberries. In

doing so, EPA considered the new safety

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

and EPA decided to grant the section 18

exemption only after concluding that

the necessary tolerance under FFDCA

section 408(l)(6) would be consistent

with the new safety standard and with

FIFRA section 18. This tolerance for

myclobutanil will permit the marketing

of strawberries treated in accordance

with the provisions of the section 18

emergency exemption. 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 be revoked on March 31,

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

residues of myclobutanil not in excess

of the amounts specified in the

tolerance remaining in or on

strawberries after that date will not be

unlawful, provided the pesticide is

applied during the term of, and in

accordance with all the conditions of,

the emergency exemption. 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.

EPA has not made any decisions

about whether myclobutanil meets the

requirements for registration under

FIFRA section 3 for use on strawberries,

or whether a permanent tolerance for

myclobutanil for strawberries would be

appropriate. This action by EPA does

not serve as a basis for registration of

myclobutanil by a State for special local

needs under FIFRA section 24(c). Nor

does this action serve as the basis for

any State other than Florida to use this

product 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.

For many of these studies, a dose

response relationship can be

determined, which provides a dose that

causes adverse effects (threshold effects)

and doses causing no observed effects

(the ‘‘no-observed effect level’’ or

‘‘NOEL’’).

Once a study has been evaluated and

the observed effects have been

determined to be threshold effects, EPA

generally divides the NOEL from the

study with the lowest NOEL by an

uncertainty factor (usually 100 or more)

to determine the Reference Dose (RfD).

The RfD is a level at or below which

daily aggregate exposure over a lifetime

will not pose appreciable risks to

human health. An uncertainty factor

(sometimes called a ‘‘safety factor’’) of

100 is commonly used since it is

assumed that people may be up to 10

times more sensitive to pesticides than

the test animals, and that one person or

subgroup of the population (such as

infants and children) could be up to 10

times more sensitive to a pesticide than

another. In addition, EPA assesses the

potential risks to infants and children

based on the weight of the evidence of

the toxicology studies and determines

whether an additional uncertainty factor

is warranted. Thus, an aggregate daily

exposure to a pesticide residue at or

below the RfD (expressed as 100 percent

or less of the RfD) is generally

considered acceptable by EPA.

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 margin of exposure

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.
17732 Federal Register / Vol. 62, No. 70 / Friday, April 11, 1997 / Rules and Regulations

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, and other

non-occupational exposures, such as

where residues leach into groundwater

or surface water that is consumed as

drinking water. 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. 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 percent of

every crop considered in the analysis is

treated with the pesticide being

evaluated. 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 and that the market for pest

control on any given crop seldomly

belongs to a single pesticide.

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.

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.

Myclobutanil is already registered by

EPA for numerous food and feed uses,

as well as residential use on annuals

and perennials, turf, shrubs and trees,

and African violets (indoor). EPA has

received a petition requesting

establishment of a tolerance for

myclobutanil on strawberries. The timelimited tolerance associated with the

current emergency exemption does not

constitute a decision regarding the

pending petition for tolerance on

strawberries. For the purposes of this

emergency exemption, EPA has

sufficient data to assess the hazards of

myclobutanil and to make a

determination on aggregate exposure,

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

time-limited tolerance for residues of

myclobutanil on strawberries at 0.5

ppm. EPA’s assessment of the dietary

exposures and risks associated with

establishing this tolerance follows.

A. Toxicological Profile

1. Chronic toxicity. The RfD of 0.025

milligrams per kilogram per day (mg/kg/

day) was established by the Agency

based on the chronic feeding study in

rats with a NOEL of 2.5 mg/kg/day and

an uncertainty factor of 100. There was

testicular atrophy at the lowest effect

level (LEL) of 9.9 mg/kg/day.

2. Acute toxicity. The Office of

Pesticide Programs (OPP) has

determined that data do not indicate the

potential for adverse effects after a

single dietary exposure.

3. Short-term toxicity. OPP has

determined that short- and

intermediate-term risk assessments are

appropriate for occupational and

residential routes of exposure. OPP

recommends that the NOEL of 100 mg/

kg/day, taken from the 21–day dermal

toxicity study in rats, be used for the

short term dermal MOE calculations.

This dose level was the highest tested in

the study. For intermediate term MOE

calculations, OPP recommended using

the NOEL of 10 mg/kg/day from the 2-

generation rat study. Effects seen at the

LEL in this study (50 mg/kg/day) were

decreases in pup body weight, an

increased incidence in number of

stillborns, and atrophy of the prostate

and testes. Though these endpoints have

been identified, no acceptable reliable

exposure data to assess these potential

risks are available at this time.

4. Carcinogenicity. Using its

Guidelines for Carcinogen Risk

Assessment published September 24,

1986 (51 FR 33992), EPA has classified

myclobutanil as Group E chemical - ‘‘no

evidence of carcinogenicity for humans’’

- based on the results of carcinogenicity

studies in two species. The doses tested

are adequate for identifying a cancer

risk.

B. Aggregate Exposure

Established U.S. tolerances for

myclobutanil and its alcohol

metabolites (free and bound) are found

in 40 CFR 180.443, and range from 0.05

ppm for milk to 5 ppm for cherries

(sweet and sour). The proposed timelimited tolerance of 0.5 ppm is based on

residue field trial data on strawberries

submitted in support of PP# 4E4302.

There are no livestock feed items

associated with the proposed use on

strawberries, so no additional livestock

dietary burden will result from this

section 18 registration. Therefore,

existing meat, milk, and poultry

tolerances are adequate.

For the purpose of assessing potential

chronic dietary exposure from

myclobutanil, EPA generally assumed

tolerance level residues and percent of

crop treated refinements to estimate the

Anticipated Residue Contribution (ARC)

from the proposed and existing food

uses of myclobutanil. The use of percent

of crop treated data for most of the

existing food uses in this analysis, as

well as the use of refined residue

information for the existing use on

bananas, results in a more refined

estimate of exposure than the TMRC.

In conducting this exposure

assessment, EPA has made conservative

assumptions—most all foods considered

in the analysis were assumed to have

myclobutanil residues present at the

level of the tolerance. Percent crop

treated data were used for many

commodities with existing myclobutanil

tolerances (stone fruits, pome fruits,

grapes, and cottonseed) in the chronic

exposure assessment, but were not

considered when calculating the dietary

burden from which secondary residue

tolerances in meat, milk and poultry

were derived or for the proposed use on

strawberries. Thus, in making a safety

determination for the subject section 18

tolerances, EPA is taking into account

this conservative exposure assessment.

In examining aggregate exposure,

FQPA directs EPA to consider available

information concerning exposures from

the pesticide residue in food and all

other non-occupational exposures. The

primary non-food sources of exposure

the Agency looks at include drinking

water (whether from groundwater or

surface water), and exposure through

pesticide use in gardens, lawns, or

buildings (residential and other indoor

uses). Review of terrestrial field

dissipation data by the Agency indicates

that myclobutanil did not leach into

groundwater in either sandy loam or

coastal soil. There is no established

Maximum Concentration Level for

residues of myclobutanil in drinking

water. No drinking water health

advisories have been issued for

myclobutanil. The ‘‘Pesticides in

Groundwater Database (EPA 734–12–

92–001, September 1992) has no

information concerning myclobutanil.

Because the Agency lacks sufficient

water-related exposure data to complete

a comprehensive drinking water risk
Federal Register / Vol. 62, No. 70 / Friday, April 11, 1997 / Rules and Regulations 17733

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 to 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.

There are residential uses of

myclobutanil and EPA acknowledges

that there may be short-, intermediate-

, and long-term non-occupational

exposure scenarios. OPP has identified

toxicity endpoints for short- and

intermediate-term residential risk

assessment. However, no acceptable,

reliable exposure data to assess these

potential risks are available at this time.

Given the time-limited nature of this

request, the need to make emergency

exemption decisions quickly, and the

significant scientific uncertainty at this

time about how to aggregate nonoccupational exposure with dietary

exposure, the Agency will make its

safety determination for this tolerance

based on those factors which it can

reasonably integrate into a risk

assessment.

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

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. Determination of Safety for U.S.

Population

EPA has calculated that chronic

dietary exposure to myclobutanil will

utilize 14 percent of the RfD for the U.S.

population. Available information

indicate that there will be little, if any

exposure to myclobutanil in drinking

water and EPA has no reliable exposure

information regarding the level of

exposure to myclobutanil from nonoccupational, non-dietary sources. EPA

generally has no concern for exposures

below 100 percent 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 concludes

that there is a reasonable certainty that

no harm will result from aggregate

exposure to myclobutanil residues.

D. Determination of Safety for Infants

and Children

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 2-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.

From the rat developmental study, the

maternal (systemic) NOEL was 93.8 mg/

kg/day, based on rough hair coat, and

salivation at the lowest observed effect

level (LOEL) of 312.6 mg/kg/day. The

developmental (pup) NOEL was 93.8

mg/kg/day, based on increased

incidences of 14th rudimentary and 7th

cervical ribs at the LOEL of 312.6 mg/

kg/day. From the rabbit developmental

study, 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 (pup) 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 LEL of 200 mg/kg/day.

From the rat reproduction study, the

maternal (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 LEL of 50 mg/kg/day.

The reproductive (parental) NOEL was

10 mg/kg/day, based on increased

incidence of stillborns, and atrophy of

the testes, epididymides, and prostate at

the LEL of 50 mg/kg/day.
17734 Federal Register / Vol. 62, No. 70 / Friday, April 11, 1997 / Rules and Regulations

FFDCA section 408 provides that EPA

shall apply an additional uncertainty

factor for infants and children in the

case of threshold effects to account for

pre- and post-natal toxicity and the

completeness of the data base unless

EPA determines, based on reliable data,

that a different uncertainty factor would

be appropriate. Generally, EPA believes

that reliable data support using the

standard hundredfold uncertainty factor

for extrapolating from animal studies to

humans, where there is a complete data

base and the effects of concern are not

such to indicate such a hundredfold

uncertainty factor is inadequate. Based

on current toxicological data

requirements, the data base for

myclobutanil relative to pre- and postnatal toxicity is complete. The Agency

notes that there is approximately a 25-

fold difference between the

developmental NOEL of 60 mg/kg/day

from the rabbit developmental toxicity

study and the NOEL of 2.5 mg/kg/day

from the chronic rat feeding study

which was the basis of the RfD. It is

further noted that in both the rabbit and

rat developmental toxicity studies, the

developmental NOEL and maternal

NOEL are the same (60 mg/kg/day for

the rabbit and 93.8 mg/kg/day for the

rat). In the rat reproduction study, the

maternal NOEL (2.5 mg/kg/day) was

four times lower than the

developmental (pup) and reproductive

NOELs (10 mg/kg/day). These studies

indicate that there does not appear to be

additional sensitivity for infants and

children in the absence of maternal

toxicity and that there is no concern that

a hundredfold uncertainty factor will be

inadequate. EPA concludes that a

hundredfold uncertainty factor is

appropriate for infants and children.

EPA has calculated that the percent of

the RfD that will be utilized by chronic

dietary exposure to residues of

myclobutanil ranges from 22 percent for

children 7 to 12 years old, up to 73

percent for non-nursing infants. Given

that aggregate exposure is still below the

Agency’s level of concern, 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

The metabolism of myclobutanil in

plants and animals is adequately

understood for the purposes of this

tolerance. There is no Codex maximum

residue level established for residues of

myclobutanil on strawberries. There is a

practical analytical method for detecting

and measuring levels of myclobutanil in

or on food with a limit of detection that

allows monitoring of food with residues

at or above the levels set in this

tolerance. EPA has provided

information on this method to the Food

and Drug Administration. The method

is available to anyone who is interested

in pesticide residue enforcement from:

By mail, Calvin Furlow, Public

Response and Program Resources

Branch, Field Operations Division

(7506C), Office of Pesticide Programs,

Environmental Protection Agency, 401

M St., SW., Washington, DC 20460.

Office location and telephone number:

Crystal Mall #2, Rm. 1128, 1921

Jefferson Davis Highway, Arlington, VA

22202, (703) 305–5805.

VI. Conclusion

Therefore, a tolerance in connection

with the FIFRA section 18 emergency

exemption is established for residues of

myclobutanil in strawberries at 0.5 ppm.

This tolerance will expire on March 31,

1998.

In addition to the new tolerance being

established, since for purposes of

establishing tolerances FQPA has

eliminated all distinctions between raw

and processed food, EPA is combining

the tolerances that now appear in

§ § 185.4350 and 186.4350 with the

tolerances in § 180.443 and is

eliminating § § 185.4350 and 186.4350.

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 June 10, 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

A record has been established for this

rulemaking under docket number [OPP

]. A public version of this record, 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 Response and

Program Resources Branch, Field

Operations Division (7506C), Office of

Pesticide Programs, Environmental

Protection Agency, Crystal Mall #2,

1921 Jefferson Davis Highway,

Arlington, VA.

The official record for this

rulemaking, as well as the public

version, as described above, is kept in

paper form. Accordingly, in the event

there are objections and hearing

requests, 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. The official rulemaking record is

the paper record maintained at the

address in ‘‘ ADDRESSES’’ at the

beginning of this document.
Federal Register / Vol. 62, No. 70 / Friday, April 11, 1997 / Rules and Regulations 17735

IX. Regulatory Assessment

Requirements

Under Executive Order 12866 (58 FR

51735, October 4, 1993), this action is

not a ‘‘significant regulatory action’’

and, since this action does not impose

any information collection requirements

as defined by the Paperwork Reduction

Act, 44 U.S.C. 3501 et seq., it is not

subject to review by the Office of

Management and Budget. In addition,

this action does not impose any

enforceable duty or contain any

unfunded mandate as described in the

Unfunded Mandates Reform Act of 1995

(Pub. L. 104–4), or require prior

consultation with State officials as

specified by Executive Order 12875 (58

FR 58093, October 28, 1993), or special

considerations as required by Executive

Order 12898 (59 FR 7629, February 16,

1994). Because FFDCA section 408(l)(6)

permits establishment of this regulation

without a notice of proposed

rulemaking, the regulatory flexibility

analysis requirements of the Regulatory

Flexibility Act, 5 U.S.C. 604(a), do not

apply.

Under 5 U.S.C. 801(a)(1)(A) of the

Small Business Regulatory Enforcement

Fairness Act of 1996 (Title II of Pub. L.

104–121, 110 Stat. 847), EPA 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 the rule in today’s Federal Register.

This rule is not a ‘‘major rule’’ as

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

List of Subjects

40 CFR Part 180

Environmental protection,

Administrative practice and procedure,

Agricultural commodities, Pesticides

and pests, Reporting and recordkeeping

requirements.

40 CFR Part 185

Environmental protection, Food and

additives, Pesticides and pest.

40 CFR Part 186

Environmental protection, Animal

feeds Pesticides and pest.

Dated: April 4, 1997.

Penelope A. Fenner-Crisp,

Acting Director, Office of Pesticide Programs.

Therefore, 40 CFR chapter I is

amended as follows:

PART 180—[AMENDED]

1. In part 180:

a. The authority citation for part 180

continues to read as follows:

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

b. Section 180.443 is amended as

follows:

i. In paragraph (a) by adding the

heading.

ii. In paragraph (b) by transferring and

alphabetically adding the entry in the

table to the table in paragraph (a) and by

removing the remaining text.

iii. In paragraph (c) by transferring

and alphabetically adding the entries in

the table to the table in paragraph (a)

and by removing the remaining text.

iv. By redesignating paragraph (d) as

paragraph (b) and by revising newly

redesignated paragraph (b).

v. By adding the headings and

reserving new paragraphs (c) and (d).

§ 180.443 Myclobutanil; tolerances for

residues.

(a) General. * * *

(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 exemption granted by EPA.

The tolerances are specified in the

following table. These tolerances expire

and are automatically revoked on the

date specified in the table.

Commodity Parts per

million

Expiration/Revocation

Date

Cucurbit vegetables ..................................................................................................................................... 0.3 November 30, 1997

Strawberries ................................................................................................................................................. 0.5 March 31, 1998

(c) Tolerances with regional

registrations. [Reserved]

(d) Indirect or inadvertent residues.

[Reserved]

PART 185—[AMENDED]

2. In part 185:

a. The authority citation for part 185

continues to read as follows:

Authority: 21 U.S.C. 346a and 348.

§ 185.4350 [Removed]

b. The entries in the table to

§ 185.4350 are transferred and added

alphabetically to the table in paragraph

(a) of § 180.443; the remainder of

§ 185.4350 is removed.

PART 186—[AMENDED]

3. In part 186:

a. The authority citation for part 186

continues to read as follows:

Authority: 21 U.S.C.342, 348, and 701.

§ 186.4350 [Removed]

b. The entries in the table to

§ 186.4350 are transferred and added

alphabetically to the table in paragraph

(a) of § 180.443; the remainder of

§ 186.4350 is removed.

[FR Doc. 97–9378 Filed 4–11–97; 8:45 am]

BILLING CODE 6560–50–F

ENVIRONMENTAL PROTECTION

AGENCY

40 CFR Parts 180, 185, and 186

[OPP–300467; FRL–5598–7]

RIN 2070–AB78

Sethoxydim; Extension of Time-limited

Pesticide Tolerance

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Final rule.

SUMMARY: This document extends the

effective dates for the established timelimited tolerances for combined

residues of the herbicide 2-[1-

(ethoxyimino)butyl]-5-[2-

(ethylthio)propyl]-3-hydroxy-2-

cyclohexen-1-one (also referred to in

this document as sethoxydim) and its

metabolites in or on various raw

agricultural commodities. The

Interregional Research Project Number 4

(IR-4) requested these time extensions

under the Federal Food, Drug and

Cosmetic Act, as amended by the Food

Quality Protection Act of 1996.

DATES: This regulation becomes

effective April 11, 1997. Objections and

hearing request must be received by

June 10, 1997.

ADDRESSES: Written objections and

hearing requests, identified by the

docket control number, [OPP–300467;

PP 0E3909, 2E4052, 2E4065, 2E4092,

and 3E4162], may be submitted to:

Hearing Clerk (1900), Environmental

Protection Agency, Rm. M3708, 401 M