1284 Federal Register / Vol. 62, No. 6 / Thursday, January 9, 1997 / Rules and Regulations

notice in electronic format (in either

ASCII text, WordPerfect 5.1 for DOS or

WordPerfect 5.2 for Windows format) on

a 31⁄2′′ diskette marked with the name of

the applicant and the words ‘‘Notice of

Filing.’’

* * * * *

PART 300—CONFIRMATION AND

APPROVAL OF THE RATES OF

FEDERAL POWER MARKETING

ADMINISTRATIONS

1. The authority citation for Part 300

continues to read as follows:

Authority: 16 U.S.C. 825s, 832–832l, 838–

838k, 839–839h; 42 U.S.C. 7101–7352; 43

U.S.C. 485–485k.

2. In § 300.10, paragraph (a)(1) is

revised to read as follows:

§ 300.10 Application for confirmation and

approval.

(a) General provisions—(1) Contents

of filing. Any application under this

subpart for confirmation and approval

of rate schedules must include, as

described in this section a letter of

request for rate approval, a form of

notice suitable for publication in the

Federal Register, as well as a copy of

the same notice in electronic format (in

either ASCII text, WordPerfect 5.1 for

DOS or WordPerfect 5.2 for Windows

format) on a 31⁄2′′ diskette marked with

the name of the applicant and the words

‘‘Notice of Filing,’’ the rate schedule, a

statement of revenue and related costs,

the order, if any, placing the rates into

effect on an interim basis, the

Administrator’s Record of Decision or

explanation of the rate development

process, supporting documents, a

certification, and technical supporting

information and analysis.

* * * * *

[FR Doc. 97–380 Filed 1–8–97; 8:45 am]

BILLING CODE 6717–01–P

ENVIRONMENTAL PROTECTION

AGENCY

40 CFR Part 180

[OPP–300447; FRL–5579–7]

RIN 2070–AB78

Myclobutanil; Pesticide Tolerances for

Emergency Exemption

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

crop group cucurbit vegetables 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 cucurbit vegetables in

California. This regulation establishes a

maximum permissible level for residues

of myclobutanil in these foods 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 automatically without further

action by EPA on November 30, 1997.

DATES: This regulation becomes

effective January 9, 1997. This

regulation expires and is revoked

automatically without further action by

EPA on November 30, 1997. Objections

and requests for hearings must be

received by EPA on March 10, 1997.

ADDRESSES: Written objections and

hearing requests, identified by the

docket control number, [OPP–300447],

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 number, [OPP–300447],

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–300447]. 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: 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, on

its own initiative, pursuant to section

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

Drug, and Cosmetic Act (FFDCA), 21

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

a tolerance for residues of the fungicide

myclobutanil [alpha-butyl-alpha-(4-

chlorophenyl)-1H–1,2,4-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 cucurbit vegetables at 0.3 part per

million (ppm). This tolerance will

expire and be revoked automatically

without further action by EPA on

November 30, 1997.

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).

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
Federal Register / Vol. 62, No. 6 / Thursday, January 9, 1997 / Rules and Regulations 1285

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) 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 Cucurbits and FFDCA

Tolerances

On July 29, 1996, the State of

California 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 watermelons to

control powdery mildew (Sphaerotheca

fuliginea). This crisis exemption was

amended August 7, 1996 to cover all

cucurbit vegetables. California stated

that emergency conditions developed

due to the outbreak of this particular

strain of powdery mildew which is

resistant to the registered product

Bayleton. Though considered a minor

pest in the past, environmental

conditions in the last 2 years have

contributed to this disease outbreak.

Without the use of myclobutanil, it is

claimed that watermelon growers

specifically, and growers of cucurbits in

general, 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 cucurbits. 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 cucurbits treated in accordance with

the provisions of the section 18

emergency exemption. Consistent with

the need to move quickly on the

emergency exemption 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 automatically without further

action by EPA on November 30, 1997,

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

of myclobutanil not in excess of the

amounts specified in the tolerance

remaining in or on cucurbits 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 cucurbits, or

whether a permanent tolerance for

myclobutanil for cucurbit vegetables

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

California 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.
1286 Federal Register / Vol. 62, No. 6 / Thursday, January 9, 1997 / Rules and Regulations

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

(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.

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 seldom

belongs to a single pesticide.

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 cucurbits. The timelimited tolerance associated with the

current emergency exemption does not

constitute a decision regarding the

pending petition for tolerance on

cucurbit vegetables. 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 cucurbit vegetables at

0.3 ppm. EPA’s assessment of the

dietary exposures and risks associated

with establishing this tolerance follows.

IV. Aggregate Risk Assessment and

Determination of Safety

A. Toxicological Profile

1. Chronic toxicity. The RfD of 0.025

milligram(mg)/kilogram(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. 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 0.3 ppm is based on

residue field trial data on cantaloupes

submitted in support of PP 9G3765 and

PP 2F4155. There are no livestock feed

items associated with the proposed use

on cucurbits, 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 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 metolachlor. The use of percent

of crop treated data for most of the

existing food uses in this analysis

results in a more refined estimate of

exposure than the TMRC. In conducting

this exposure assessment, EPA has

made conservative assumptions—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 cucurbit vegetables.

Thus, in making a safety determination

for the subject Section 18 tolerances,

EPA is taking into account this

conservative exposure assessment.

Other potential sources of exposure of

the general population to residues of

pesticides are residues in drinking water

and exposure from non-occupational

sources. Based on the available studies

used in EPA’s assessment of

environmental risk, EPA does not

anticipate exposure to residues of

myclobutanil in drinking water. 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
Federal Register / Vol. 62, No. 6 / Thursday, January 9, 1997 / Rules and Regulations 1287

information concerning myclobutanil.

Based on the available data, the Agency

does not anticipate that there will be

significant exposure to the general

population from myclobutanil residues

in drinking water.

There are residential uses of

myclobutanil and EPA acknowledges

that there may be short-, intermediateand 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.

At this time, the Agency has not made

a determination that myclobutanil and

other substances that may have a

common mode of toxicity would have

cumulative effects. 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

define common mode of toxicity, the

Agency will make its safety

determination for this tolerance based

on those factors which it can reasonably

integrate into a risk assessment. For

purposes of this tolerance only, the

Agency is considering only the potential

risks of myclobutanil in its aggregate

exposure.

C. Determination of Safety for U.S.

Population

EPA has calculated that chronic

dietary exposure to myclobutanil will

utilize 13.5 percent of the RfD for the

U.S. population. 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 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.

FFDCA section 408 provides that EPA

may apply an additional safety 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. Based on current

toxicological data requirements, the data

base for myclobutanil relative to preand post-natal 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.

EPA has calculated that the percent of

the RfD that will be utilized by chronic

dietary exposure to residues of

myclobutanil ranges from 21.8 percent

for children 7 to 12 years old, up to 73.1

percent for non-nursing infants. Given

the conservative assumptions used in

the calculation of dietary risk, it is felt

that even a conservative assumption of

transfer of residues to drinking water

would result in an aggregate exposure

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 cucurbits. 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 FDA. 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 Hwy., 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 cucurbits at 0.3 ppm.

This tolerance will expire and be

automatically revoked without further

action by EPA on November 30, 1997.

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

sections 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
1288 Federal Register / Vol. 62, No. 6 / Thursday, January 9, 1997 / Rules and Regulations

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 March 10, 1997,

file written objections to any aspect of

this regulation (including the automatic

revocation provision) 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 number [OPP–

300447] (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 4:00

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.

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 address in

ADDRESSES at the beginning of this

document.

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

Administrative Procedure Act (APA) as

amended by 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) of the APA

as amended.

List of Subjects in 40 CFR Part 180

Environmental protection,

Administrative practice and procedure,

Agricultural commodities, Pesticides

and pests, Reporting and recordkeeping

requirements.

Dated: January 2, 1997.

Daniel M. Barolo,

Director, Office of Pesticide Programs.

Therefore, 40 CFR Chapter I is

amended as follows:

PART 180—[AMENDED]

1. The authority citation for part 180

continues to read as follows:

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

2. In § 180.443, by adding a new

paragraph (d) to read as follows:

§ 180.443 Myclobutanil; tolerances for

residues.

* * * * *

(d) A time-limited tolerance is

established for residues of the fungicide

myclobutanil, in connection with use of

the pesticide under section 18

emergency exemption granted by EPA.

The tolerance is specified in the

following table. This tolerance expires

and is automatically revoked on the date

specified in the table without further

action by EPA.

Commodity

Parts

per

million

Expiration/revocation date

Cucurbit vegetables.0.3 Nov. 30, 1997.

[FR Doc. 97–514 Filed 1–8–97; 8:45 am]

BILLING CODE 6560–50–F

40 CFR Part 180

[OPP–300448; FRL–5581–9]

RIN 2070–AB78

Zinc Phosphide; Pesticide Tolerances

for Emergency Exemptions

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Final rule.

SUMMARY: This regulation establishes

time-limited tolerances for residues of

phosphine resulting from the use of the

rodenticide zinc phosphide in or on the