Federal Register / Vol. 66, No. 80 / Wednesday, April 25, 2001 / Notices 20811

other substances that have a common

mechanism of toxicity is also

considered. There is no reliable

information to indicate that toxic effects

produced by cyhalofop-butyl,

cyhalofop-acid and cyhalofop-diacid

would be cumulative with those of any

other pesticide chemical. Thus, it is

appropriate to consider only the

potential risks of cyhalofop-butyl and

cyhalofop-acid in an aggregate exposure

assessment.

E. Safety Determination

1. U.S. population. Using the

conservative exposure assumptions

described above, and based on the

completeness and reliability of the

toxicity data, aggregate exposure to

cyhalofop-butyl, as determined under

the guidance of the FQPA, will utilize

no more than 1.3% of the reference dose

(RfD) from the dietary exposure for all

subgroups of the U.S. population.

Generally, and under the FQPA, EPA

has no concern for exposures below

100% of the RfD because the RfD

represents the level at or below which

daily aggregate dietary exposure over a

lifetime will not pose appreciable risks

to human health. Therefore, there is a

reasonable certainty that no harm will

result from exposure to cyhalofop-butyl

residues.

2. Infants and children. Data from

developmental toxicity studies in rats

and rabbits and a multigeneration

reproduction study in the rat are

considered in assessing the potential for

additional sensitivity of infants and

children to residues of cyhalofop-butyl.

The developmental toxicity studies are

designed to evaluate adverse effects on

the developing organism resulting from

pesticide exposure during prenatal

development. Reproduction studies

provide information relating to effects

from exposure of both parents to the

pesticide on the reproductive capability

and potential systemic toxicity of

mating animals and on various

parameters associated with the wellbeing of offspring. 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 prenatal and postnatal

toxicity and the completeness of the

data base. Based on the current

toxicological data requirements, the data

base for cyhalofop-butyl relative to

prenatal and postnatal effects for

children is complete. Overall,

cyhalofop-butyl had no effect on

reproduction or embryo-fetal

development at any dosage tested.

Further, for cyhalofop-butyl, the no

observed adverse effect level (NOAEL)

in the chronic mouse study (0.3 mg/kg/

day), which was used to calculate the

RfD (0.003 mg/kg/day), is already lower

than the NOAELs from the

developmental studies in rats and

rabbits. Therefore, an additional FQPA

uncertainty factor is not needed and the

RfD at 0.003 mg/kg/day is appropriate

for assessing risk to infants and

children. Using the conservative

exposure assumptions previously

described, the percent RfD utilized by

the potential aggregate exposure to

residues of cyhalofop-butyl on rice is

about 1.3% for non-nursing infants, the

most sensitive population subgroup.

Therefore, based on the completeness

and reliability of the toxicity data and

the conservative exposure assessment,

Dow AgroSciences LLC concludes that

there is a reasonable certainty that no

harm will result to infants and children

from aggregate exposure to cyhalofopbutyl on rice.

F. International Tolerances

There is no Codex maximum residue

level established for residues of

cyhalofop-butyl, cyhalofop-acid and

cyhalofop-diacid on any food or feed

crop.

[FR Doc. 01–10122 Filed 4–24–01; 8:45 am]

BILLING CODE 6560–50–S

ENVIRONMENTAL PROTECTION

AGENCY

[PF–1018; FRL–6778–4]

Notice of Filing a Pesticide Petition to

Establish a Tolerance for a Certain

Pesticide Chemical in or on Food

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Notice.

SUMMARY: This notice announces the

initial filing of a pesticide petition

proposing the establishment of

regulations for residues of a certain

pesticide chemical in or on various food

commodities.

DATES: Comments, identified by docket

control number PF–1018, must be

received on or before May 25, 2001.

ADDRESSES: Comments may be

submitted by mail, electronically, or in

person. Please follow the detailed

instructions for each method as

provided in Unit I.C. of the

SUPPLEMENTARY INFORMATION. To ensure

proper receipt by EPA, it is imperative

that you identify docket control number

PF–1018 in the subject line on the first

page of your response.

FOR FURTHER INFORMATION CONTACT: By

mail: Leonard Cole, Registration

Division (7505C), Office of Pesticide

Programs, Environmental Protection

Agency, 1200 Pennsylvania Ave., NW.,

Washington, DC 20460; telephone

number: (703) 305–5412; e-mail address:

cole.leonard@epa.gov.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

You may be affected by this action if

you are an agricultural producer, food

manufacturer or pesticide manufacturer.

Potentially affected categories and

entities may include, but are not limited

to:

Categories NAICS

codes

Examples of potentially affected

entities

Industry 111 Crop production

112 Animal production

311 Food manufacturing

32532 Pesticide manufacturing

This listing is not intended to be

exhaustive, but rather provides a guide

for readers regarding entities likely to be

affected by this action. Other types of

entities not listed in the table could also

be affected. The North American

Industrial Classification System

(NAICS) codes have been provided to

assist you and others in determining

whether or not this action might apply

to certain entities. If you have questions

regarding the applicability of this action

to a particular entity, consult the person

listed under FOR FURTHER INFORMATION

CONTACT.

B. How Can I Get Additional

Information, Including Copies of this

Document and Other Related

Documents?

1. Electronically. You may obtain

electronic copies of this document, and

certain other related documents that

might be available electronically, from

the EPA Internet Home Page at http://

www.epa.gov/. To access this

document, on the Home Page select

‘‘Laws and Regulations,’’ ‘‘Regulations

and Proposed Rules,’’ and then look up

the entry for this document under the

‘‘Federal Register—Environmental

Documents.’’ You can also go directly to

the Federal Register listings at http://

www.epa.gov/fedrgstr/.

2. In person. The Agency has

established an official record for this

action under docket control number PF–

1018. The official record consists of the

documents specifically referenced in

this action, any public comments

received during an applicable comment

period, and other information related to

this action, including any information

20812 Federal Register / Vol. 66, No. 80 / Wednesday, April 25, 2001 / Notices

claimed as confidential business

information (CBI). This official record

includes the documents that are

physically located in the docket, as well

as the documents that are referenced in

those documents. The public version of

the official record does not include any

information claimed as CBI. The public

version of the official record, which

includes printed, paper versions of any

electronic comments submitted during

an applicable comment period, is

available for inspection in the Public

Information and Records Integrity

Branch (PIRIB), Rm. 119, Crystal Mall

#2, 1921 Jefferson Davis Highway,

Arlington, VA, from 8:30 a.m. to 4 p.m.,

Monday through Friday, excluding legal

holidays. The PIRIB telephone number

is (703) 305–5805.

C. How and to Whom Do I Submit

Comments?

You may submit comments through

the mail, in person, or electronically. To

ensure proper receipt by EPA, it is

imperative that you identify docket

control number PF–1018 in the subject

line on the first page of your response.

1. By mail. Submit your comments to:

Public Information and Records

Integrity Branch (PIRIB), Information

Resources and Services Division

(7502C), Office of Pesticide Programs

(OPP), Environmental Protection

Agency, 1200 Pennsylvania Ave., NW.,

Washington, DC 20460.

2. In person or by courier. Deliver

your comments to: Public Information

and Records Integrity Branch (PIRIB),

Information Resources and Services

Division (7502C), Office of Pesticide

Programs (OPP), Environmental

Protection Agency, Rm. 119, Crystal

Mall #2, 1921 Jefferson Davis Highway,

Arlington, VA. The PIRIB is open from

8:30 a.m. to 4 p.m., Monday through

Friday, excluding legal holidays. The

PIRIB telephone number is (703) 305–

5805.

3. Electronically. You may submit

your comments electronically by e-mail

to: opp-docket@epa.gov, or you can

submit a computer disk as described

above. Do not submit any information

electronically that you consider to be

CBI. Avoid the use of special characters

and any form of encryption. Electronic

submissions will be accepted in

Wordperfect 6.1/8.0 or ASCII file

format. All comments in electronic form

must be identified by docket control

number PF–1018. Electronic comments

may also be filed online at many Federal

Depository Libraries.

D. How Should I Handle CBI That I

Want to Submit to the Agency?

Do not submit any information

electronically that you consider to be

CBI. You may claim information that

you submit to EPA in response to this

document as CBI by marking any part or

all of that information as CBI.

Information so marked will not be

disclosed except in accordance with

procedures set forth in 40 CFR part 2.

In addition to one complete version of

the comment that includes any

information claimed as CBI, a copy of

the comment that does not contain the

information claimed as CBI must be

submitted for inclusion in the public

version of the official record.

Information not marked confidential

will be included in the public version

of the official record without prior

notice. If you have any questions about

CBI or the procedures for claiming CBI,

please consult the person identified

under FOR FURTHER INFORMATION

CONTACT.

E. What Should I Consider as I Prepare

My Comments for EPA?

You may find the following

suggestions helpful for preparing your

comments:

1. Explain your views as clearly as

possible.

2. Describe any assumptions that you

used.

3. Provide copies of any technical

information and/or data you used that

support your views.

4. If you estimate potential burden or

costs, explain how you arrived at the

estimate that you provide.

5. Provide specific examples to

illustrate your concerns.

6. Make sure to submit your

comments by the deadline in this

notice.

7. To ensure proper receipt by EPA,

be sure to identify the docket control

number assigned to this action in the

subject line on the first page of your

response. You may also provide the

name, date, and Federal Register

citation.

II. What Action is the Agency Taking?

EPA has received a pesticide petition

as follows proposing the establishment

and/or amendment of regulations for

residues of a certain pesticide chemical

in or on various food commodities

under section 408 of the Federal Food,

Drug, and Cosmetic Act (FFDCA), 21

U.S.C. 346a. EPA has determined that

this petition contains data or

information regarding the elements set

forth in section 408(d)(2); however, EPA

has not fully evaluated the sufficiency

of the submitted data at this time or

whether the data support granting of the

petition. Additional data may be needed

before EPA rules on the petition.

List of Subjects

Environmental protection,

Agricultural commodities, Feed

additives, Food additives, Pesticides

and pests, Reporting and recordkeeping

requirements.

Dated: April 9, 2001.

James Jones,

Director, Registration Division, Office of

Pesticide Programs.

Summary of Petition

The petitioner summary of the

pesticide petition is printed below as

required by section 408(d)(3) of the

FFDCA. The summary of the petition

was prepared by the petitioner and

represents the view of the petitioner.

EPA is publishing the petition summary

verbatim without editing it in any way.

The petition summary announces the

availability of a description of the

analytical methods available to EPA for

the detection and measurement of the

pesticide chemical residues or an

explanation of why no such method is

needed.

FMC Corp.

PP 1F6266

EPA has received a pesticide petition

(PP 1F6266) from FMC Corp., 1735

Market Street, Philadelphia, PA 19103

proposing, pursuant to section 408(d) of

the Federal Food, Drug, and Cosmetic

Act (FFDCA), 21 U.S.C. 346a(d), to

amend 40 CFR part 180 by establishing

a tolerance for residues of bifenthrin ((2-

methyl 1,1′-biphenyl-3-yl) methyl-3-(2-

chloro-3,3,3,-trifluoro-1-propenyl)-2,2-

dimethylcyclopropanecarboxylate) in or

on the raw agricultural commodity

citrus fruits at 0.05 parts per million

(ppm). EPA has determined that the

petition contains data or information

regarding the elements set forth in

section 408(d)(2) of the FFDCA;

however, EPA has not fully evaluated

the sufficiency of the submitted data at

this time or whether the data support

granting of the petition. Additional data

may be needed before EPA rules on the

petition.

A. Residue Chemistry

1. Plant metabolism. The metabolism

of bifenthrin in plants is adequately

understood. Studies have been

conducted to delineate the metabolism

of radiolabelled bifenthrin in various

crops all showing similar results. The

residue of concern is the parent

compound only.

Federal Register / Vol. 66, No. 80 / Wednesday, April 25, 2001 / Notices 20813

2. Analytical method. There is a

practical analytical method for detecting

and measuring levels of bifenthrin in or

on food with a limit of detection that

allows monitoring of food with residues

at or above the levels set in these

tolerances (Gas Chromatography with

Electron Capture Detection (GC/ECD)

analytical method P-2132M, PP 0E3921,

MRID 41658601).

3. Magnitude of residues. Field

residue trials meeting EPA study

requirements have been conducted at

the maximum label rate for the crop

subgroup leaf petioles. Results from

these trials demonstrate that the highest

bifenthrin residues found will not

exceed the proposed tolerance of 2.0

ppm when the product is applied

following the proposed use directions.

B. Toxicological Profile

1. Acute toxicity. For the purposes of

assessing acute dietary risk, FMC has

used the maternal NOAEL of 1.0 mg/kg/

day from the oral developmental

toxicity study in rats. The maternal

lowest effect level (LEL) of this study of

2.0 mg/kg/day was based on tremors

from day 7–17 of dosing. This acute

dietary endpoint is used to determine

acute dietary risks to all population

subgroups.

2. Genotoxicity. The following

genotoxicity tests were all negative:

gene mutation in Salmonella (Ames);

chromosomal aberrations in Chinese

hamster ovary and rat bone marrow

cells; HGPRT locus mutation in mouse

lymphoma cells; and unscheduled DNA

synthesis in rat hepatocytes.

3. Reproductive and developmental

toxicity—i.Rat reproduction study.

Parental toxicity occurred as decreased

body weight at 5.0 milligrams/

kilograms/day (mg/kg/day) with a no

observed adverse effect level (NOAEL)

of 3.0 mg/kg/day. There were no

developmental (pup) or reproductive

effects up to 5.0 mg/kg/day (highest

dose tested).

ii. Postnatal sensitivity. Based on the

absence of pup toxicity up to dose levels

which produced toxicity in the parental

animals, there is no evidence of special

postnatal sensitivity to infants and

children in the rat reproduction study.

4. Subchronic toxicity. The maternal

NOAEL of 1.0 mg/kg/day from the oral

developmental toxicity study in rats is

also used for short- and intermediateterm margins of exposure (MOE)

calculations (as well as acute, discussed

in (1) above). The maternal LEL of this

study of 2.0 mg/kg/day was based on

tremors from day 7–17 of dosing.

5. Chronic toxicity—i. The reference

dose (RfD) has been established at 0.015

mg/kg/day. This RfD is based on a 1–

year oral feeding study in dogs with a

NOAEL of 1.5 mg/kg/day, based on

intermittent tremors observed at the

lowest observed adverse effect level

(LOAEL) of 3.0 mg/kg/day; an

uncertainty factor of 100 is used.

ii. Bifenthrin is classified as a Group

C chemical (possible human carcinogen)

based upon urinary bladder tumors in

mice; assignment of a Q* has not been

recommended.

6. Animal metabolism. The

metabolism of bifenthrin in animals is

adequately understood. Metabolism

studies in rats with single doses

demonstrated that about 90% of the

parent compound and its hydroxylated

metabolites are excreted.

7. Metabolite toxicology. The Agency

has previously determined that the

metabolites of bifenthrin are not of

toxicological concern and need not be

included in the tolerance expression.

8. Endocrine disruption. No special

studies investigating potential

estrogenic or other endocrine effects of

bifenthrin have been conducted.

However, no evidence of such effects

was reported in the standard battery of

required toxicology studies, which have

been completed and found acceptable.

Based on these studies, there is no

evidence to suggest that bifenthrin has

an adverse effect on the endocrine

system.

C. Aggregate Exposure

1. Dietary exposure—i. Food.

Tolerances have been established for the

residues of bifenthrin, in or on a variety

of raw agricultural commodities.

Tolerances, in support of registrations,

currently exist for residues of bifenthrin

on the following crops: hops,

strawberries, corn (grain, forage and

fodder), sweet corn, eggplant,

cottonseed, artichokes, peppers (bell

and non-bell), lettuce (head) and grapes.

Also for the crop group cucurbit

vegetables and the subgroups ediblepodded legume, succulent shelled peas,

caneberries and brassica (head and

stem). Also, for the livestock

commodities of cattle, goats, hogs,

horses, sheep, poultry, eggs and milk.

Pending tolerances for citrus, bananas,

peanuts, pears, potatoes, spinach and

the subgroup herbs also exist. For the

purposes of assessing the potential

dietary exposure for these existing and

pending tolerances, FMC has utilized

available information on anticipated

residues, monitoring data and percent

crop treated as follows:

a. Acute exposure and risk. Acute

dietary exposure risk assessments are

performed for a food-use pesticide if a

toxicological study has indicated the

possibility of an effect of concern

occurring as a result of a 1 day or single

exposure. For the purposes of assessing

acute dietary risk for bifenthrin, the

maternal NOAEL of 1.0 mg/kg/day from

the oral developmental toxicity study in

rats was used. The maternal LEL of this

study of 2.0 mg/kg/day was based on

tremors from day 7–17 of dosing. This

acute dietary endpoint was used to

determine acute dietary risks to all

population subgroups. Available

information on anticipated residues,

monitoring data and percent crop

treated was incorporated into a Tier 3

analysis; using Monte Carlo modeling

for commodities that may be consumed

in a single serving. These assessments

show that the MOEs are greater than the

EPA standard of 100 for all

subpopulations. The 99.9th percentile of

exposure for the overall U. S.

population was estimated to be

0.004291 mg/kg/day (MOE of 233). The

99.9th percentile of exposure for all

infants less than 1 year old was

estimated to be 0.002903 mg/kg/day

(MOE of 344). The 99.9th percentile of

exposure for nursing infants less than 1

year old was estimated to be 0.002058

mg/kg/day (MOE of 485). The 99.9th

percentile of exposure for non-nursing

infants less than 1 year old was

estimated to be 0.003030 mg/kg/day

(MOE of 330). The 99.9th percentile of

exposure for children 1 to 6 years old

(the most highly exposed population

subgroup) was estimated to be 0.008328

mg/kg/day (MOE of 120). Therefore,

FMC concludes that the acute dietary

risk of bifenthrin, as estimated by the

dietary risk assessment, does not appear

to be of concern.

b. Chronic exposure and risk. The

acceptable RfD is based on a NOAEL of

1.5 mg/kg/day from the chronic dog

study and an uncertainty factor of 100

is 0.015 mg/kg/day. The endpoint effect

of concern was tremors in both sexes of

dogs at the LEL of 3.0 mg/kg/day. A

chronic dietary exposure/risk

assessment has been performed for

bifenthrin using the above RfD. The

chronic exposures are estimated to be

0.000165 mg/kg body weight (bwt)/day

and utilize 1.1% of the RfD for the

overall U.S. population. Children 1-6

years old (subgroups most highly

exposed) is estimated to be 0.000342

mg/kg bwt/day and utilizes 2.3% of the

RfD. Generally speaking, the EPA has no

cause for concern if the total dietary

exposure from residues for uses for

which there are published and proposed

tolerances is less than 100% of the RfD.

Therefore, FMC concludes that the

chronic dietary risk of bifenthrin, as

estimated by the dietary risk

20814 Federal Register / Vol. 66, No. 80 / Wednesday, April 25, 2001 / Notices

assessment, does not appear to be of

concern.

ii. Drinking water. Laboratory and

field data have demonstrated that

bifenthrin is immobile in soil and will

not leach into ground water. Other data

show that bifenthrin is virtually

insoluble in water and extremely

lipophilic. As a result, FMC concludes

that residues reaching surface waters

from field runoff will quickly adsorb to

sediment particles and be partitioned

from the water column. Further, a

screening evaluation of leaching

potential of a typical pyrethroid was

conducted using EPA’s Pesticide Root

Zone Model (PRZM3). Based on this

screening assessment, the potential

concentrations of a pyrethroid in ground

water at depths of 1 and 2 meters are

essentially zero (<<0.001 parts per

billion (ppb)). Surface water

concentrations for pyrethroids were

estimated using PRZM3 and Exposure

Analysis Modeling System (EXAMS)

using standard EPA cotton runoff and

Mississippi pond scenarios. The

maximum concentration predicted in

the simulated pond was 0.052 ppb.

Concentrations in actual drinking water

would be much lower than the levels

predicted in the hypothetical, small,

stagnant farm pond model since

drinking water derived from surface

water would normally be treated before

consumption. Based on these analyses,

the contribution of water to the dietary

risk estimate is negligible. Therefore,

FMC concludes that together these data

indicate that residues are not expected

to occur in drinking water.

2. Non-dietary exposure. Laboratory

and field data have demonstrated that

bifenthrin is immobile in soil and will

not leach into ground water. Other data

show that bifenthrin is virtually

insoluble in water and extremely

lipophilic. As a result, FMC concludes

that residues reaching surface waters

from field runoff will quickly adsorb to

sediment particles and be partitioned

from the water column. Further, a

screening evaluation of leaching

potential of a typical pyrethroid was

conducted using EPA’s PRZM3. Based

on this screening assessment, the

potential concentrations of a pyrethroid

in ground water at depths of 1 and 2

meters are essentially zero (<<0.001

parts per billion). Surface water

concentrations for pyrethroids were

estimated using PRZM3 and EXAMS

using standard EPA cotton runoff and

Mississippi pond scenarios. The

maximum concentration predicted in

the simulated pond was 0.052 ppb.

Concentrations in actual drinking water

would be much lower than the levels

predicted in the hypothetical, small,

stagnant farm pond model since

drinking water derived from surface

water would normally be treated before

consumption. Based on these analyses,

the contribution of water to the dietary

risk estimate is negligible. Therefore,

FMC concludes that together these data

indicate that residues are not expected

to occur in drinking water.

D. Cumulative Effects

In consideration of potential

cumulative effects of bifenthrin and

other substances that may have a

common mechanism of toxicity, to our

knowledge there are currently no

available data or other reliable

information indicating that any toxic

effects produced by bifenthrin would be

cumulative with those of other chemical

compounds; thus only the potential

risks of bifenthrin have been considered

in this assessment of its aggregate

exposure. FMC intends to submit

information for EPA to consider

concerning potential cumulative effects

of bifenthrin consistent with the

schedule established by EPA at 62 FR

42020 (August 4, 1997) and other EPA

publications pursuant to the FQPA.

E. Safety Determination

1. U.S. population. For the overall

U.S. population, the calculated MOE at

the 95th percentile was estimated to be

619; 348 at the 99th percentile; and 176

at the 99.9th percentile. For all infants

less than 1 year old, the calculated MOE

at the 95th percentile was estimated to

be 532; 233 at the 99th percentile; and

169 at the 99.9th percentile. For nursing

infants less than 1 year old, the

calculated MOE at the 95th percentile

was estimated to be 1,309; 450 at the

99th percentile; and 240 at the 99.9th

percentile. For non-nursing infants less

than 1 year old, the calculated MOE at

the 95th percentile was estimated to be

474; 181 at the 99th percentile; and 168

at the 99.9th percentile. For the most

highly exposed population subgroup,

children1–6 years old, the calculated

MOE at the 95th percentile was

estimated to be 320; 208 at the 99th

percentile; and 100 at the 99.9th

percentile. Therefore, FMC concludes

that there is reasonable certainty that no

harm will result from acute exposure to

bifenthrin.

2. Infants and children—i. General. In

assessing the potential for additional

sensitivity of infants and children to

residues of bifenthrin, FMC considered

data from developmental toxicity

studies in the rat and rabbit, and a twogeneration reproductive study in the rat.

The developmental toxicity studies are

designed to evaluate adverse effects on

the developing organism resulting from

pesticide exposure during prenatal

development to one or both parents.

Reproduction studies provide

information relating to effects from

exposure to the pesticide on the

reproductive capability of mating

animals and data on systemic toxicity.

FFDCA section 408 provides that EPA

may apply an additional margin of

safety for infants and children in the

case of threshold effects to account for

prenatal and postnatal toxicity and the

completeness of the data base.

ii. Developmental toxicity studies. In

the rabbit developmental study, there

were no developmental effects observed

in the fetuses exposed to bifenthrin. The

maternal NOAEL was 2.67 mg/kg/day

based on head and forelimb twitching at

the LOAEL of 4 mg/kg/day. In the rat

developmental study, the maternal

NOAEL was 1 mg/kg/day, based on

tremors at the LOAEL of 2 mg/kg/day.

The developmental (pup) NOAEL was

also 1 mg/kg/day, based upon increased

incidence of hydroureter at the LOAEL

2 mg/kg/day. There was 5/23 (22%)

litters affected (5/141 fetuses since each

litter only had one affected fetus) in the

2 mg/kg/day group, compared with zero

in the control, 1, and 0.5 mg/kg/day

groups. According to recent historical

data (1992-1994) for this strain of rat,

incidence of distended ureter averaged

11% with a maximum incidence of

90%.

iii. Reproductive toxicity study. In the

rat reproduction study, parental toxicity

occurred as decreased body weight at

5.0 mg/kg/day with a NOAEL of 3.0 mg/

kg/day. There were no developmental

(pup) or reproductive effects up to 5.0

mg/kg/day (highest dose tested).

iv. Prenatal and postnatal

sensitivity—a.Prenatal. Since there was

not a dose-related finding of hydroureter

in the rat developmental study and in

the presence of similar incidences in the

recent historical control data, the

marginal finding of hydroureter in rat

fetuses at 2 mg/kg/day (in the presence

of maternal toxicity) is not considered a

significant developmental finding. Nor

does it provide sufficient evidence of a

special dietary risk (either acute or

chronic) for infants and children which

would require an additional safety

factor.

b. Postnatal. Based on the absence of

pup toxicity up to dose levels, which

produced toxicity in the parental

animals, there is no evidence of special

postnatal sensitivity to infants and

children in the rat reproduction study.

v. Conclusion. Based on the above,

FMC concludes that reliable data

support use of the standard 100-fold

uncertainty factor, and that an

additional uncertainty factor is not

Federal Register / Vol. 66, No. 80 / Wednesday, April 25, 2001 / Notices 20815

needed to protect the safety of infants

and children. As stated above, aggregate

exposure assessments utilized less than

10% of the RfD for either the entire U.

S. population or any of the 26

population subgroups including infants

and children. Therefore, it may be

concluded that there is reasonable

certainty that no harm will result to

infants and children from aggregate

exposure to bifenthrin residues.

F. International Tolerances

There are no Codex, Canadian, or

Mexican residue limits for the residue of

bifenthrin in or on leaf petioles.

[FR Doc. 01–10125 Filed 4–24–01 8:45 am]

BILLING CODE 6560–50–S

FEDERAL COMMUNICATIONS

COMMISSION

Public Information Collections

Approved by Office of Management

and Budget

April 17, 2001.

The Federal Communications

Commission (FCC) has received Office

of Management and Budget (OMB)

approval for the following public

information collections pursuant to the

Paperwork Reduction Act of 1995,

Public Law 104–13. An agency may not

conduct or sponsor and a person is not

required to respond to a collection of

information unless it displays a

currently valid control number. For

further information contact Shoko B.

Hair, Federal Communications

Commission, (202) 418–1379.

Federal Communications Commission

OMB Control No.: 3060–0741.

Expiration Date: 4/30/2004.

Title: Implementation of the Local

Competition Provisions of the

Telecommunications Act of 1996, CC

Docket No. 96–98, Second Report and

Order and Memorandum Opinion and

Order, Second Order on

Reconsideration, CC docket No. 99–273,

First Report and Order.

Form No.: N/A.

Respondents: Business or other forprofit.

Estimated Annual Burden: 2000

respondents; 114 hours per response

(avg.); 228,030 total annual burden

hours (for all collections approved

under this control number).

Estimated Annual Reporting and

Recordkeeping Cost Burden: $60,000.

Frequency of Response: On occasion;

Third Party Disclosure.

Description: In the First Report and

Order issued in CC Docket No. 99–273

(FCC 01–27), released January 23, 2001,

the Commission adopted several of its

tentative conclusions. The Commission

concluded that the phrase ‘‘in any

format’’ found in section 222(e) of the

Communications Act of 1934, as

amended, brings within the protections

of section 222(e) those entities that seek

subscriber list information to publish

directories on the Internet. That phrase

‘‘in any format’’ makes clear Congress’

intent not to restrict the kinds of

directories that could be published

using subscriber list information

obtained pursuant to section 222(e).

Internet databases that contain

subscriber list information clearly fall

within the very broad category of

‘‘directories in any format.’’ In order for

directory publishers to provide accurate

directory listings, it is essential that

publishers have access to the subscriber

list information local exchange carriers

(LECs) acquire from their customers.

(No. of respondents: 2000; hours per

response: 8 hours; total annual burden:

16,000 hours). The Commission

determined that competing directory

assistance (DA) providers that offer call

completion services for local or toll

calls, provide telephone exchange, or

telephone toll services, respectively,

and thus qualify for nondiscriminatory

access to LEC local directory assistance

databases. The Commission also

determined that because LECs do not

have monopoly control over national

directory assistance databases that LECs

obtain from third parties, that LECs are

not required to grant competing

directory assistance providers

nondiscriminatory access to such nonlocal directory assistance databases. The

Commission concluded that LECs

should not be required to provide

nondicriminatory access to nonlocal

directory listings since third parties

have the same opportunities to secure

the information directly. However, to

the extent that a carrier provides access

to national DA information to any other

DA provider, including another LEC, it

must make that same information

available to competing DA providers

under nondiscriminatory rates, terms,

and conditions. The Commission

concluded that when a competitive

local exchange carrier (CLEC) or an

interexchange carrier (IXC) (having

entered an interconnection agreement

with the relevant LEC) designates a DA

provider to act as their agent, that

competing DA provider is entitled to

nondiscriminatory access to the

providing LEC’s local DA database. The

DA providers database access will be

consistent with the terms of the relevant

interconnection agreement and with the

terms of the DA providers’ separate

agreements with its carrier principal.

The Commission expects that a DA

provider’s request for access will be

accompanied by a letter or other

documentation from the CLEC or IXC

evidencing its intent that the DA

provider receives database access so that

it fulfills its obligations to the CLEC or

IXC. (No. of respondents: 250; hours per

response: 36 hours; total annual burden:

9000 hours). All of the collections

implement the requirements of Sections

251 and/or 222 of the Communications

Act of 1934, as amended. Obligation to

respond: Mandatory.

OMB Control No.: 3060–0756.

Expiration Date: 10/31/2001.

Title: Procedural Requirements and

Policies for Commission Processing of

Bell Operating Companies Applications

for the Provision of In-Region,

InterLATA Services Under Section 271

of the Telecommunications Act of 1996.

Form No.: N/A.

Respondents: Business or other forprofit; State, Local or Tribal

Government.

Estimated Annual Burden: 75

respondents; 250 hours per response

(avg.); 18,820 total annual burden hours.

Estimated Annual Reporting and

Recordkeeping Cost Burden: $0.

Frequency of Response: On occasion;

Third Party Disclosure.

Description: In a Public Notice

released March 23, 2001 (DA 01–734),

the Commission updated the general

procedural requirements and policies

relating to the Commission processing

of Bell Operating Company (BOC)

applications to provide in-region,

interLATA services pursuant to section

271 of the Communications Act of 1934,

as amended, 47 U.S.C. Section 271

(Act). A BOC may decide whether and

when to file an application. See Public

Notice, DA 01–734. a. Submission of

Applications by the BOCs. BOCs must

file applications which provide

information on which the applicant

intends to rely in order to satisfy the

requirements of section 271. The

applications will contain two parts,

which include: (1) a stand-alone

document entitled Brief in Support of

Application by [Bell company name] for

Provision of In-region, InterLATA

services in [State name] and (2) any

supporting documentation. (Number of

respondents: 4 BOCs) hours per

response: 125 hours per state; total

annual burden: 6125 hours). b.

Submission on Written Consultations by

the State Regulatory Commissions. State

regulatory commissions will file any

written consultation they wish the

Commission to consider early in the

application process. (Number of