Federal Register / Vol. 62, No. 54 / Thursday, March 20, 1997 / Rules and Regulations 13337

COLORADO—PM–10—Continued

Designated area

Designation Classification

Date Type Date Type

AQCR 12 (excluding the Aspen/Pitkin County and Steamboat Springs Area

Airshed PM–10 nonattainment areas).

11/15/90 Unclassifiable

AQCR 13 (excluding the Canon City PM–10 nonattainment area) .................. 1/15/90 Unclassifiable

[FR Doc. 97–7096 Filed 3–19–97; 8:45 am]

BILLING CODE 6560–50–P

40 CFR Part 180

[OPP–300461; FRL–5595–3]

RIN 2070–AC78

Tebufenozide; Pesticide Tolerances for

Emergency Exemptions

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Final rule.

SUMMARY: This regulation establishes

time-limited tolerances for residues of

the insecticide tebufenozide in or on the

raw agricultural commodities sugar beet

roots, sugar beet tops, sugar beet

molasses, sugar beet refined sugar and

sugar beet dried pulp in connection

with EPA’s granting of emergency

exemptions under section 18 of the

Federal Insecticide, Fungicide, and

Rodenticide Act authorizing use of

tebufenozide on sugar beets in

California. This regulation establishes

maximum permissible levels for

residues of tebufenozide on sugar beets.

These tolerances will expire on March

30, 1998.

DATES: This regulation becomes

effective March 20, 1997. This entries in

the table expire on March 30, 1998.

Objections and requests for hearings

must be received by EPA on May 19,

1997.

ADDRESSES: Written objections and

hearing requests, identified by the

docket control number, [OPP–300461],

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–

300461], 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 Highway,

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–300461]. 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: Pat Cimino, 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)

308–8328, e-mail:

cimino.pat@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 tolerances for

residues of the insecticide tebufenozide

(benzoic acid, 3,5-dimethyl-1-(1,1-

dimethylethyl)-2-(4-

ethylbenzoyl)hydrazide) in or on sugar

beet roots at 0.3 parts per million (ppm),

sugar beet tops at 0.6 ppm, sugar beet

dried pulp at 6.0 ppm, and sugar beet

molasses and refined sugar at 4.0 ppm.

These tolerances will expire by EPA on

March 30, 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 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 FFDCA 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 FFDCA 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.’’

FFDCA 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 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.

FFDCA 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
13338 Federal Register / Vol. 62, No. 54 / Thursday, March 20, 1997 / Rules and Regulations

exemption granted by EPA under

section 18 of FIFRA.

FFDCA section 408(l)(6) also requires

EPA to promulgate regulations by

August 3, 1997, governing the

establishment of tolerances and

exemptions under FFDCA section

408(l)(6) and requires that the

regulations be consistent with FFDCA

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

section 18.

FFDCA 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 FFFDCA section

408(e) and (l)(6) without notice and

comment rulemaking.

In establishing FIFRA section 18-

related tolerances and exemptions

during this interim period before EPA

issues the FFDCA section 408(l)(6)

procedural regulation and before EPA

makes its broad policy decisions

concerning the interpretation and

implementation of the new FFDCA

section 408, EPA does not intend to set

precedents for the application of FFDCA

section 408 and the new safety standard

to other tolerances and exemptions.

Rather, these early FIFRA 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 FIFRA section 18-

related tolerances and exemptions that

clearly qualify under the new law.

II. Emergency Exemptions for

Tebufenozide on Sugar Beets and

FFDCA Tolerances

On October 11, 1996, the California

Environmental Protection Agency,

Department of Pesticide Regulation

requested a specific exemption under

FIFRA section 18 for the use of

tebufenozide to control Granulate

Cutworm (Agrotis subterranea) on sugar

beets. Sugar beets grown in Imperial

County, California are severely infested

with granulate cutworms and growers

have already experienced economic loss

from this pest. The registered alternative

products do not provide control of this

pest and lack of a viable alternative is

responsible for acreage loss over the last

several years. Growers will experience

significant economic loss if the pest is

not controlled. After having reviewed

their submission, EPA concurs that an

emergency condition exists.

As part of its assessment of these

applications for emergency exemption,

EPA assessed the potential risks

presented by residues of tebufenozide

on sugar beets. In doing so, EPA

considered the new safety standard in

FFDCA section 408(b)(2), and EPA

decided to grant the FIFRA section 18

exemptions only after concluding that

the necessary tolerance under FFDCA

section 408(l)(6) would clearly be

consistent with the new safety standard

and with FIFRA section 18. These

tolerances for tebufenozide will permit

the marketing of sugar beets treated in

accordance with the provisions of the

FIFRA section 18 emergency

exemptions. Consistent with the need to

move quickly on the emergency

exemptions and to ensure that the

resulting food is safe and lawful, EPA is

issuing this tolerance without notice

and opportunity for public comment

under FFDCA section 408(e) as

provided in FFDCA section 408(l)(6).

Although these tolerances will expire

and be revoked by EPA on March 30,

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

residues of tebufenozide not in excess of

the amount specified in the tolerances

remaining in or on sugar beets 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

exemptions. 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 tebufenozide meets the

requirements for registration under

FIFRA section 3 for use on sugar beets

or whether permanent tolerances for

tebufenozide for sugar beets would be

appropriate. This action by EPA does

not serve as a basis for registration of

tebufenozide 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 FIFRA section 18 as

identified in 40 CFR 180.166. For

additional information regarding the

emergency exemptions for tebufenozide,

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 by EPA to pose a reasonable

certainty of no harm.

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.

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
Federal Register / Vol. 62, No. 54 / Thursday, March 20, 1997 / Rules and Regulations 13339

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

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.

IV. Aggregate Risk Assessment and

Determination of Safety

Consistent with FFDCA section

408(b)(2)(D), EPA has reviewed the

available scientific data and other

relevant information in support of this

action. Tebufenozide is not registered by

EPA for indoor or outdoor residential

use. Existing food and feed use

tolerances for tebufenozide are listed in

40 CFR 180.482. EPA has sufficient data

to assess the hazards of tebufenozide

and to make a determination on

aggregate exposure, consistent with

FFDCA section 408(b)(2), for the timelimited tolerances for residues of

tebufenozide in or on sugar beet roots at

0.3 ppm, sugar beet tops at 0.6 ppm,

sugar beet dried pulp at 6.0 ppm, and

sugar beet molasses and refined sugar at

4.0 ppm. EPA’s assessment of the

dietary exposures and risks associated

with establishing these tolerances

follows.

A. Toxicological Profile

1. Chronic toxicity. Based on the

available chronic toxicity data, the

EPA’s Office of Pesticide Programs

(OPP) has established the RfD for

tebufenozide at 0.018 milligrams/

kilogram/day (mg/kg/day). The RfD is

based on a 1–year feeding study in dogs

with a NOEL of 1.8 mg/kg/day and an

uncertainty factor of 100. Decreased red

blood cells, hematocrit, and hemoglobin

and increased heinz bodies,

reticulocytes, and platelets were

observed at the Lowest-Observed Effect

Level (LOEL) of 8.7 mg/kg/day.

2. Acute toxicity. No appropriate

acute dietary endpoint was identified by

OPP. This risk assessment is not

required.

3. Carcinogenicity. Using its

Guidelines for Carcinogen Risk

Assessment published September 24,

1986 (51 FR 33992), OPP has classified

tebufenozide as a Group ‘‘E’’ chemical

(no evidence of carcinogenicity) based

on the results of carcinogenicity studies

in two species. There was no evidence

of carcinogenicity in a 2–year rat study

and an 18–month mouse study.

B. Aggregate Exposure

Tolerances for residues of

tebufenozide are currently expressed as

benzoic acid, 3,5-dimethyl-1-(1,1-

dimethylethyl)-2-(4-ethylbenzoyl)

hydrazide. Tolerances currently exist for

residues on apples and walnuts (see 40

CFR 180.482).

For purposes of assessing the

potential dietary exposure under this

tolerance, EPA assumed tolerance level

residues and 100 percent of crop treated

to estimate the TMRC from all

established food uses for tebufenozide

(walnuts and import tolerances for

apples) as well as other recently granted

emergency exemption uses (peppers)

and the proposed use on sugar beets.

There are sugar beet animal feed items.

However, the residue levels in animal

commodities potentially resulting from

feeding of these commodities would

most likely be undetectable. For

purposes of the FIFRA section 18

emergency exemption only, the Agency

is not recommending establishment of

time-limited tolerances for tebufenozide

on animal commodities.

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).

Based on the available studies used in

EPA’s assessment of environmental risk,

tebufenozide is moderately persistent to

persistent and mobile, and could

potentially leach to groundwater and

runoff to surface water under certain

environmental conditions. There is no

established Maximum Concentration

Level for residues of tebufenozide in

drinking water. No drinking water

health advisory levels have been

established for tebufenozide. There is no

entry for tebufenozide in the ‘‘Pesticides

in Groundwater Database’’ (EPA 734–

12–92–001, September 1992).

Because the Agency lacks sufficient

water-related 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.

A more detailed description of this

analysis is included in the docket for

this rulemaking. While EPA has not yet

pinpointed the appropriate bounding

figure for consumption of contaminated

water, the ranges the Agency is

continuing to examine are all well

below the level that would cause

tebufenozide to exceed the RfD if the

tolerances being considered in this

document were granted.

The Agency has therefore concluded

that the potential exposures associated

with tebufenozide 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 tolerances are

granted.

C. Cumulative Exposure to Substances

with Common Mechanism of Toxicity

FFDCA 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
13340 Federal Register / Vol. 62, No. 54 / Thursday, March 20, 1997 / Rules and Regulations

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

tebufenozide 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,

tebufenozide 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 tebufenozide has a

common mechanism of toxicity with

other substances.

D. Safety Determinations for U.S.

Population

Based on the completeness and

reliability of the toxicity data and the

conservative TMRC dietary exposure

assumptions, EPA has concluded that

dietary exposure from food to

tebufenozide will utilize 11.9 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. Whatever

reasonable bounding figure the Agency

eventually decides upon for the

contribution from water, that number is

expected to be well below 88.1% of the

RfD. EPA concludes that there is a

reasonable certainty that no harm will

result from aggregate exposure to

tebufenozide residues.

E. Determination of Safety for Infants

and Children

In assessing the potential for

additional sensitivity of infants and

children to residues of tebufenozide,

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.

Developmental toxicity was not

observed in developmental studies

using rats and rabbits. The NOEL for

developmental effects in both rats and

rabbits was 1,000 mg/kg/day (HDT),

which is the limit dose for testing in

developmental studies.

In the two-generation reproductive

toxicity study in the rat, the

reproductive/developmental toxicity

NOEL of 12.1 mg/kg/day was

fourteenfold higher than the parental

(systemic) toxicity NOEL (0.85 mg/kg/

day). The reproductive (pup) LOEL of

171.1 mg/kg/day was based on a slight

increase in both generations in the

number of pregnant females that either

did not deliver or had difficulty and had

to be sacrificed. In addition, the length

of gestation increased and implantation

sites decreased significantly in F1 dams.

Because these reproductive effects

occurred in the presence of parental

(systemic) toxicity, these data do not

suggest an increased post-natal

sensitivity to children and infants (that

infants and children might be more

sensitive than adults) to tebufenozide

exposure.

FFDCA section 408 provides that EPA

shall apply an additional tenfold margin

of exposure (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 exposure (safety)

will be safe for infants and children.

Margins of exposure (safety) are often

referred to as uncertainty (safety)

factors. EPA believes that reliable data

support using the standard margin of

exposure (usually 100x for combined

inter- and intra-species variability) and

not the additional tenfold margin of

exposure 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 margin of exposure. Based

on current toxicological data

requirements, the database for

tebufenozide relative to pre- (provided

by rat and rabbit developmental studies)

and post-natal (provided by the rat

reproduction study) toxicity is

complete. The additional uncertainty

factor is not needed to protect the safety

of infants and children.

Based on TMRC exposure estimates

for food, as described above, EPA has

concluded that the percentage of the

RfD that will be utilized by dietary

exposure to residues of tebufenozide

ranges from 18.8 percent for children 7

to 12 years old, up to 53.3 percent for

non-nursing infants (the most highly

exposed population subgroup).

Therefore, taking into account the

completeness and reliability of the

toxicity data and the conservative

exposure assessment, EPA concludes

that there is a reasonable certainty that

no harm will result to infants and

children from aggregate exposure to

tebufenozide residues.

V. Other Considerations

The metabolism of tebufenozide in

plants is adequately understood for the

purposes of this tolerance. There is no

Codex maximum residue level

established for residues of tebufenozide

on sugar beets. There is a practical

analytical method (liquid

chromatography with ultraviolet

detection) for detecting and measuring

levels of tebufenozide in or on food with

a limit of detection that allows

monitoring of food with residues at or

above the level set by the tebufenozide

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.
Federal Register / Vol. 62, No. 54 / Thursday, March 20, 1997 / Rules and Regulations 13341

Office location and telephone number:

Crystal Mall #2, Rm 1128, 1921 Jefferson

Davis Highway, Arlington, VA 22202,

703–305–5805.

VI. Conclusion

Therefore, tolerances in connection

with the FIFRA section 18 emergency

exemptions are established for residues

of tebufenozide in or on sugar beet roots

at 0.3 ppm, sugar beet tops at 0.6 ppm,

dried pulp at 6.0 ppm, and molasses

and refined sugar at 4.0 ppm. These

tolerances will expire and be revoked on

March 30, 1998.

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

FFDCA 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 May 19, 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–

300461]. 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.

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 record keeping

requirements.

Dated: March 11, 1997.

Stephen L. Johnson,

Acting 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 § 180.482(b), by adding

alphabetically the following entries to

the table:

§ 180.482 Tebufenozide; tolerances for

residues.

* * * * *

(b) * * *
13342 Federal Register / Vol. 62, No. 54 / Thursday, March 20, 1997 / Rules and Regulations

Commodity Parts per

million Expiration/Revocation Date

* * * * *

Sugar beet, tops ................................................................................................................................. 0.6 March 30, 1998

Sugar beet, roots ............................................................................................................................... 0.3 March 30, 1998

Sugar beet, dried pulp ....................................................................................................................... 6.0 March 30, 1998

Sugar beet, molasses ........................................................................................................................ 4.0 March 30, 1998

Sugar beet, refined sugar .................................................................................................................. 4.0 March 30, 1998

* * * * *

[FR Doc. 97–7062 Filed 3–19–97; 8:45 am]

BILLING CODE 6560–50–F

GENERAL SERVICES

ADMINISTRATION

41 CFR Ch. 301

[FTR Am. 56]

RIN 3090–AG36

Federal Travel Regulation; Maximum

Per Diem Rates

AGENCY: Office of Governmentwide

Policy, GSA.

ACTION: Final rule.

SUMMARY: This final rule amends

Federal Travel Regulation (FTR)

Amendment 52, published in the

Federal Register on Thursday,

November 21, 1996 (61 FR 59185) to

add per diem localities in the States of

Louisiana and Virginia, and to add the

State of North Dakota with a clarifying

footnote (number 5), explaining that all

locations within that State are subject to

the standard CONUS rate. This rule also

corrects footnote number three and an

incorrect entry listed in the prescribed

maximum per diem rate for Gettysburg

(Adams County), Pennsylvania.

DATES: This final rule is effective

January 1, 1997, and applies for travel

performed on or after January 1, 1997.

FOR FURTHER INFORMATION CONTACT:

Joddy P. Garner, Travel and

Transportation Management Policy

Division (MTT), Washington, DC 20405,

telephone 202–501–1538.

SUPPLEMENTARY INFORMATION: The

General Services Administration has

determined that this rule is not a

significant regulatory action for the

purposes of Executive Order 12866 of

September 30, 1993. This final rule is

not required to be published in the

Federal Register for notice and

comment. Therefore, the Regulatory

Flexibility Act does not apply. This rule

also is exempt from congressional

review prescribed under 5 U.S.C. 801

since it relates solely to agency

management and personnel. For reasons

set out in the preamble, under 5 U.S.C.

5701–5709, title 41, Chapter 301 of the

Code of Federal Regulation is revised to

read as follows:

CHAPTER 301—TRAVEL ALLOWANCES

1. Appendix A to Chapter 301 is

amended by adding and correcting the

following per diem localities and

footnote 3 to read as follows:

Appendix A to Chapter 301—

Prescribed Maximum Per Diem Rates

for CONUS

* * * * *

Per diem locality Maximum

lodging

amount

(a)

+

M&IE

rate

(b)

=

Maximum

per diem

rate 4

(c) Key city 1 County and/or other defined location 2,3

Louisiana:

St. Francisville .............................................. West Feliciana ..................................................... 85 30 115

North Dakota: (See footnote 5)

Pennsylvania:

Gettysburg .................................................... Adams ................................................................. ................ ................ ................

(May 1–October 31) ............................................ 68 34 102

(November 1–April 30) ........................................ 62 34 96

Virginia:

Harrisonburg ................................................. Harrisonburg ........................................................ 51 30 81

1 Unless otherwise specified, the per diem locality is defined as ‘‘all locations within, or entirely surrounded by, the corporate limits of the key

city, including independent entities located within those boundaries.’’ 2Per diem localities with county definitions shall include ‘‘all locations within, or entirely surrounded by, the corporate limits of the key city as

well as the boundaries of the listed counties, including independent entities located within the boundaries of the key city and the listed counties.’’ 3When a military installation or Government-related facility (whether or not specifically named) is located partially within more than one city or

county boundary, the applicable per diem rate for the entire installation or facility is the higher of the two rates which apply to the cities and/or

counties, even though part(s) of such activities may be located outside the defined per diem locality. 4Federal agencies may submit a request to GSA for review of the costs covered by per diem in a particular city or area where the standard

CONUS rate applies when travel to that location is repetitive or on a continuing basis and travelers’ experiences indicate that the prescribed rate

is inadequate. Other per diem localities listed in this appendix will be reviewed on an annual basis by GSA to determine whether rates are adequate. Requests for per diem rate adjustments shall be submitted by the agency headquarters office to the General Services Administration, Office of Governmentwide Policy, Attn: Travel and Transportation Management Policy Division (MTT), Washington, DC 20405. Agencies should

designate an individual responsible for reviewing, coordinating, and submitting to GSA any requests from bureaus or subagencies. Requests for

rate adjustments shall include a city designation, a description of the surrounding location involved (county or other defined area), and a recommended rate supported by a statement explaining the circumstances that cause the existing rate to be inadequate. The request also must

contain an estimate of the annual number of trips to the location, the average duration of such trips, and the primary purpose of travel to the locations. Agencies should submit their requests to GSA no later than May 1 in order for a city to be included in the annual review. 5The standard CONUS rate of $80 ($50 for lodging and $30 for M&IE) applies to all per diem localities in the State of North Dakota.