9984 Federal Register / Vol. 62, No. 43 / Wednesday, March 5, 1997 / Rules and Regulations

Commodities Parts per

million

Cereal grains group (except

rice, wild rice, sweet corn

and wheat, grain ................... 20.0

Cereal grains group (except

rice, wild rice, sweet corn

and wheat), hay .................... 15.0

Cereal grains group (except

rice, wild rice, sweet corn

and wheat), stover (fodder) ... 1.0

Cereal grains group (except

rice, wild rice, sweet corn

and wheat), straw .................. 4.0

Soybeans .................................. 30.0

Soybean, forage ....................... 10.0

Soybean, hay ............................ 10.0

[FR Doc. 97–5415 Filed 3–4–97; 8:45 am]

BILLING CODE 6560–50–F

40 CFR Part 180

[OPP–300456; FRL–5591–7]

RIN 2070–AC78

Tebufenozide; Pesticide Tolerances for

Emergency Exemptions

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Final rule.

SUMMARY: This regulation establishes a

time-limited tolerance for combined

residues of the insecticide tebufenozide

in or on the raw agricultural

commodities peppers, non-brassica

leafy vegetables (Crop Group 4 - celery,

lettuce, spinach, swiss chard), turnips

grown for foliage tops only, and brassica

(cole) leafy vegetables (Crop Group 5 -

broccoli, cabbage, cauliflower, collards,

kale, kohlrabi, and mustard greens) 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 peppers, leafy

vegetables (except brassica), turnips

grown for foliage tops only and brassica

leafy vegetables in Texas; and lettuce,

broccoli, cauliflower, cabbage and

spinach in Arizona. This regulation

establishes maximum permissible levels

for residues of tebufenozide in these

foods. These tolerances will expire on

February 28, 1998.

DATES: This regulation becomes

effective March 5, 1997. This regulation

expires on February 28, 1998.

Objections and requests for hearings

must be received by EPA on May 5,

1997.

ADDRESSES: Written objections and

hearing requests, identified by the

docket control number, [OPP–300456],

must be submitted to: Hearing Clerk

(1900), Environmental Protection

Agency, Rm. M3708, 401 M St., SW.,

Washington, DC 20460. Fees

accompanying objections and hearing

requests shall be labeled ‘‘Tolerance

Petition Fees’’ and forwarded to: EPA

Headquarters Accounting Operations

Branch, OPP (Tolerance Fees), P.O. Box

360277M, Pittsburgh, PA 15251. A copy

of any objections and hearing requests

filed with the Hearing Clerk identified

by the docket control number, [OPP–

300456], 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–300456]. 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), Office of Pesticide Programs,

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)

308–8328, 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 a tolerance for

residues of the insecticide tebufenozide

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

dimethylethyl)-2-(4-

ethylbenzoyl)hydrazide) in or on

peppers at 0.5 part per million (ppm),

leafy vegetables (except brassica) at 5.0

ppm, turnip tops at 5.0 ppm, and

brassica (cole) leafy vegetables at 5.0

ppm. These tolerances will expire on

February 28, 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 section 408 with a new

safety standard and new procedures.

These activities were discussed in detail

in the final rule establishing the timelimited tolerance for an 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

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
Federal Register / Vol. 62, No. 43 / Wednesday, March 5, 1997 / Rules and Regulations 9985

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 Exemptions for

Tebufenozide on Peppers, Leafy

Vegetables (except Brassica), Turnip

Tops, and Cole Leafy Vegetables

(Brassica) and FFDCA Tolerances

On December 18, and 20, 1996, the

Texas Department of Agriculture availed

of itself the authority to declare the

existence of a crisis situation within the

State, thereby authorizing use under

FIFRA section 18 of tebufenozide on

leafy vegetables (non-brassica), turnip

tops and brassica leafy vegetables to

control the beet armyworm (BAW),

respectively. The states of Texas and

Arizona have also requested specific

exemptions for use of this chemical to

control beet armyworm on brassica and

non-brassica leafy vegetable, turnip tops

and peppers. Emergency conditions are

determined to exist due to: (1) The BAW

populations demonstrating resistance to

registered insecticides causing control

failures when these products are

applied to BAW; (2) a mild winter and

unusually dry, hot weather have

increased the survival rate of the pest.

Natural controls, such as disease,

needed cooler, wetter conditions to have

their greatest impact on this pest; and

(3) the unusually large numbers of

BAW. According to the Applicant,

estimated yield losses due to BAW in

peppers and non-brassica leafy

vegetables could result in a 50% yield

loss and a 30% yield for brassica (cole)

leafy vegetables without the use of an

effective pesticide.

As part of its assessment of these

applications for emergency exemption,

EPA assessed the potential risks

presented by residues of tebufenozide

on brassica (cole), non-brassica leafy

vegetables, turnip tops and peppers. In

doing so, EPA considered the new safety

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

and EPA decided to grant the 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. This

tolerance for tebufenozide will permit

the marketing of brassica (cole) and nonbrassica leafy vegetables, turnip tops

and peppers treated in accordance with

the provisions of the 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 these tolerances

without notice and opportunity for

public comment under section 408(e) as

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

these tolerances will expire on February

28, 1998, under FFDCA section

408(l)(5), residues of tebufenozide not in

excess of the amount specified in the

tolerance remaining in or on brassica

(cole) , and non-brassica leafy

vegetables, turnip tops and peppers 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 these tolerances 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 brassica

(cole) and non-brassica leafy vegetables,

turnip tops and peppers or whether a

permanent tolerance for tebufenozide on

these crops 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 Texas or Arkansas to use this

product on this crop under section 18 of

FIFRA without following all provisions

of 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 no

appreciable risk.

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
9986 Federal Register / Vol. 62, No. 43 / Wednesday, March 5, 1997 / Rules and Regulations

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

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 Assessments,

Cumulative Risk Discussion, 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.

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. At this time EPA is not in

possession of a registration application

for tebufenozide on brassica (cole) and

non-brassica leafy vegetables, turnip

tops, and peppers. However, based on

the information submitted to the Agency

thus far, EPA has sufficient data to

assess the hazards of tebufenozide and

to make a determination on aggregate

exposure, consistent with section

408(b)(2), for the time-limited tolerances

for residues of tebufenozide on brassica

(cole) leafy vegetables at 5.0 ppm, nonbrassica leafy vegetables at 5.0 ppm,

turnip tops at 5.0 ppm and peppers at

0.5 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 for

humans) 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. Permanent

tolerances currently exist for residues

on apples and walnuts (see 40 CFR

180.482).

For purposes of assessing the chronic

dietary exposure from tebufenozide,

EPA assumed tolerance level residues

and 100 percent of crop treated

refinements to estimate the TMRC from

all established existing food uses for

tebufenozide as well as the proposed

use on leafy vegetables, turnip tops and

peppers. Neither peppers nor any of the

commodities comprising Crop Group 4

(Non-brassica leafy vegetables) and 5

(Brassica Cole Leafy vegetables) are

considered livestock feed items; thus,

there is no reasonable expectation that

measurable residues of tebufenozide

will occur in meat, milk, poultry, or

eggs under the terms of these emergency

exemptions. Although, turnip tops

potentially are a ruminant feed item,

conversation with the Texas Department

of Agriculture indicates that the turnip

tops treated under this section 18 are

destined for fresh market use only.

Nonetheless, even if those turnip tops

were fed to ruminants, potential residue

levels in animal commodities would

most likely be undetectable. For

purposes of this section 18 registration

only, OPP concludes that tolerances for

animal commodities are not needed.

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, tebufenozide is

moderately persistent to persistent and

mobile, and could potentially leach to

groundwater and runoff to surface water

under certain environmental conditions.

There are no established Maximum

Concentration Levels 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).

The Agency does not have available

data to perform a quantitative drinking

water risk assessment for tebufenozide

at this time. However, in order to

mitigate the potential for tebufenozide

to leach into groundwater or runoff to

surface water, precautionary language

has been incorporated into the product

label.

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.

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 below the level that

would cause tebufenozide 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

tebufenozide in water, even at the

higher levels the Agency is considering
Federal Register / Vol. 62, No. 43 / Wednesday, March 5, 1997 / Rules and Regulations 9987

as a conservation upper bound, would

not prevent the Agency from

determining that there is a reasonable

certainty of no harm if the tolerance is

granted.

Tebufenozide is not registered for

either indoor or outdoor residential use.

Non-occupational exposure to the

general population is therefore not

expected and not considered in

aggregate exposure estimates.

C. Cumulative Exposure to Substances

with Common Mechanisms of Toxicity

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

when considering whether to establish,

modify, or revoke a tolerance, the

Agency consider ‘‘available

information’’ concerning the cumulative

effects of a particular pesticide’s

residues and ‘‘other substances that

have a common mechanism of toxicity.’’

The Agency believes that ‘‘available

information’’ in this context might

include not only toxicity, chemistry,

and exposure data, but also policies and

methodologies for conducting

cumulative risk assessments. While 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

methodology to fully resolve the

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 enable

the Agency to apply common

mechanism issues to its pesticide risk

assessments. At present, however, the

Agency does not know how to apply the

information in its files concerning

common mechanism issues to most risk

assessments.

In making individual tolerance

decisions, the Agency will determine

whether:

1. It has sufficient information to

determine that a pesticide does not

appear to share a common mechanism

of toxicity with other substances.

2. It is unable to conclude that a

pesticide does not share a common

mechanism of toxicity with other

substances.

For pesticides falling into the first

category, the Agency will explain its

determination and factor the

determination into the tolerance

decision. For pesticides falling into the

second category, the Agency will

conclude that it does not have sufficient

available information concerning

common mechanism of toxicity to

scientifically apply that information to

the tolerance decision, the tolerance

decision will be reached based upon the

best available and useful information for

the individual chemical, and a risk

assessment will be performed for the

individual chemical assuming that no

common mechanism of toxicity exists.

However, tolerance decisions falling

into the second category will be

reexamined by the Agency after EPA

establishes methodologies and

procedures for integrating information

concerning common mechanism into its

risk assessments. In such circumstances,

related registration actions may be

conditioned upon the provision of such

data as may be necessary to evaluate

common mechanism of toxicity issues

in a risk assessment.

Tebufenozide falls into the second

category and at this time, the Agency

has not made a determination that

tebufenozide and other substances that

may have a common mode of toxicity

would have cumulative effects. EPA has

not yet determined whether to include

this chemical in a cumulative risk

assessment. This tolerance

determination does not take into

account common mechanism issues.

The Agency will reexamine tolerances

for tebufenozide, after the Agency has

developed a methodology for applying

common mechanism of toxicity issues

to risk assessments.

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 these tolerances

based on those factors which it can

reasonably integrate into a risk

assessment. For purposes of these

tolerances only, the Agency is

considering only the potential risks of

tebufenozide in its aggregate exposure.

D. Safety Determinations for U.S.

Population

EPA has concluded that chronic

dietary exposure to tebufenozide will

utilize 27% 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. Despite the potential

for exposure to tebufenozide in drinking

water, EPA does not expect the

aggregate exposure to exceed 100% of

the RfD. EPA concludes that there is a

reasonable certainty that no harm will

result 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 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 (pre-natal) 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

the highest dose tested (HDT), which

demonstrates that no toxicity was

present for tebufenozide.

In the two-generation reproductive

toxicity study in the rat, the

reproductive/developmental toxicity

NOEL of 12.1 mg/kg/day was 14–fold

higher than the parental (systemic)

toxicity NOEL (0.85 mg/kg/day), which

indicates that post-natal toxicity in the

production studies occurs only in the

presence of significant parental toxicity.

These developmental and

reproduction studies indicate that

tebufenozide does not have additional

sensitivity for infants and children in

comparison to other exposed groups.

The TMRC value for the most highly

exposed infant and children subgroup

(non-nursing infants <1 year old)

occupies 61% of the RfD. However, this

calculation assumes 100% crop treated

and uses tolerance level residues for all

commodities. Refinement of the dietary

risk assessment by using percent crop

treated and anticipated residue data

would greatly reduce dietary exposure.

Therefore, this risk assessment is an

over-estimate of dietary risk.

Consideration of anticipated residues

and percent crop treated would likely

result in an anticipated residue

contribution (ARC) which would

occupy a percent of the RfD that is

likely to be significantly lower than the

currently calculated TMRC value.

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.
9988 Federal Register / Vol. 62, No. 43 / Wednesday, March 5, 1997 / Rules and Regulations

FFDCA section 408 provides that EPA

shall 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 unless EPA concludes

that a different margin of safety is

appropriate. EPA has concluded that the

database on this pesticide is sufficiently

complete regarding potential effects on

infants and children and that the studies

demonstrate no additional sensitivity in

infants and children. Therefore, EPA

concludes that an additional uncertainty

factor is not warranted and that the RfD

at 0.018 mg/kg/day based on a 100–fold

safety is adequate for protecting infants

and children.

V. Other Considerations

The metabolism of tebufenozide in

plants is adequately understood for the

purposes of this tolerance. There are no

Mexican, Canadian or Codex

International maximum residue levels

established for residues of tebufenozide.

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 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 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 at 0.5 ppm in peppers,

5.0 ppm in/on leafy vegetables (brassica

and non-brassica-cole), and 5.0 ppm in/

on turnip tops grown for foliage tops

only. These tolerances will expire on

February 28, 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

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 5, 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–

300456]. A public version of this record,

which does not include any information

claimed as CBI, is available for

inspection from 8:30 am to 4 pm,

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, 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

Virginia 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
Federal Register / Vol. 62, No. 43 / Wednesday, March 5, 1997 / Rules and Regulations 9989

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: February 25, 1997.

Peter Caulkins,

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, the section heading

and the table in paragraph (b) are

revised to read as follows:

§ 180.482 Tebufenozide; tolerances for

residues.

* * * * *

(b) * * *

Commodity Parts per

million

Expiration/Revocation

Date

Leafy Vegetable (Cole -brassica) ................................................................................................................ 5.0 February 28, 1998

Leafy Vegetables (non-brassica) ................................................................................................................. 5.0 February 28, 1998

Peppers ........................................................................................................................................................ 0.5 February 28, 1998

Turnip Tops .................................................................................................................................................. 5.0 February 28, 1998

[FR Doc. 97–5414 Filed 3–4–97; 8:45 am]

BILLING CODE 6560–50–F

FEDERAL COMMUNICATIONS

COMMISSION

47 CFR Part 68

Connection of Telephone Equipment to

the Telephone Network; Correction

AGENCY: Federal Communications

Commission.

ACTION: Final rule; correcting

amendments.

SUMMARY: This document contains

corrections to the final regulations

which related to the connection of

terminal equipment to the telephone

network. (61 FR 42386 August 15, 1996)

EFFECTIVE DATE: March 5, 1997.

FOR FURTHER INFORMATION CONTACT:

William von Alven, (202) 418–2342.

SUPPLEMENTARY INFORMATION:

Background

The final regulations that are the

subject of these corrections relate to the

means of connection of equipment

making use of the Public Switched

Digital Service (PSDS) and the

Integrated Services Digital Network

(ISDN).

Need for Correction

As published, the final regulations

contain errors which may prove to be

misleading and are in need of

correction.

List of Subjects in 47 CFR Part 68

Communications equipment,

Telephone.

Accordingly, 47 CFR Part 68 is

amended by making the following

correction:

PART 68—CONNECTION OF

TERMINAL EQUIPMENT TO THE

TELEPHONE NETWORK

1. The authority citation for Part 68

continues to read as follows:

Authority: Secs. 1, 4, 5, 201–5, 208, 215,

218, 226, 227, 303, 313, 403, 404, 410, 602

of the Communications Act of 1934 as

amended, 47 U.S.C. 151. 154. 155. 201–5,

208, 215, 218, 226, 227, 303, 314, 403, 410,

602, 610.

§ 68.308 [Corrected]

2. Section 68.308 is amended by

revising the heading to the introductory

text of paragraph (h)(3) and adding new

paragraph (h)(4) to read as follows:

§ 68.308 Signal power limitations.

* * * * *

(h) * * *

(3) PSDS Types II and III Maximum

Output Pulse Templates.

* * * * *

(4) Limitations on Terminal

Equipment Connected to ISDN BRA. If

registered terminal equipment

connecting to ISDN BRA services

contains a digital-to-analog converter, or

generates signals directly in digital

form, which are intended for eventual

conversion into voiceband analog

signals, the encoded analog content of

the digital signal must be limited. The

maximum equivalent power of the

encoded analog signals, other than live

voice as derived from a zero-leveldecoder test configuration, shall not

exceed –12 dBm when averaged over a

three second interval. The maximum

equivalent power of encoded analog

signals, as derived by a zero-level

decoder test configuration, for network

control signaling, shall not exceed –3

dBm when averaged over any threesecond interval.

Federal Communications Commission.

William F. Caton,

Acting Secretary.

[FR Doc. 97–5352 Filed 3–4–97; 8:45 am]

BILLING CODE 6712–01–M

47 CFR Part 73

[MM Docket No. 96–9; RM–8736]

Radio Broadcasting Services; Ukiah,

CA

AGENCY: Federal Communications

Commission.

ACTION: Final rule; Petition for

reconsideration.

SUMMARY: This document dismisses a

petition for partial reconsideration filed

on behalf of LifeTalk Broadcasting

Association (‘‘LifeTalk’’) of the Report

and Order in this proceeding, which

allotted Channel 246A to Ukiah,

California, as that community’s fourth

local commercial FM transmission

service, rather than reserving Channel

246A for noncommercial educational

use, as requested by LifeTalk. See 61 FR

58340, November 14, 1996. LifeTalk

subsequently requested the withdrawal

of its petition for partial

reconsideration. With this action, the

proceeding is terminated.

EFFECTIVE DATE: April 14, 1997.

FOR FURTHER INFORMATION CONTACT:

Nancy Joyner, Mass Media Bureau, (202)

418–2180.

SUPPLEMENTARY INFORMATION: This is a

synopsis of the Commission’s

Memorandum Opinion and Order, MM

Docket No. 96–9, adopted February 21,

1997, and released February 28, 1997.