Federal Register / Vol. 65, No. 93 / Friday, May 12, 2000 / Notices 30591

(1400A), U.S. Environmental Protection

Agency, 1200 Pennsylvania Avenue,

NW, Washington, DC 20460; telephone

(202) 564–4558; FAX (202) 501–0582; or

via e-mail at miller.tom@epa.gov.

Requests for oral comments must be in

writing (e-mail, fax or mail) and

received by Mr. Miller no later than

noon Eastern Time on May 30, 2000.

3. SAB Executive Committee (EC)

Teleconference—June 12, 2000

The Executive Committee (EC) of US

EPA’s Science Advisory Board will

conduct a public teleconference meeting

on Monday, June 12, 2000 between the

hours of 1 and 3 pm Eastern Daylight

Time. The meeting will be coordinated

through a conference call connection in

Room 6013 in the USEPA, Ariel Rios

Building North, 1200 Pennsylvania

Avenue, NW, Washington, DC. The

public is encouraged to attend the

meeting in the conference room noted

above. However, the public may also

attend through a telephonic link, to the

extent that lines are available.

Additional instructions about how to

participate in the conference call can be

obtained by calling Ms. Priscilla TilleryGadsen no earlier than one week prior

to the meeting (beginning on May 29) at

(202) 564–4533, or via e-mail at

tillery.priscilla@epa.gov.

Purpose of the Meeting—In this

meeting, the Executive Committee plans

to review reports from some of its

Committees/Subcommittee, most likely

including the following:

(a) EC Subcommittee on Data from the

Testing of Human Subjects: ‘‘Report on

Data from the Testing of Human

Subjects’’

(b) EC Subcommittee on Review of

Cancer Guidelines: ‘‘Applicability of the

Agency’s Cancer Risk assessment

Guidelines to Children’’

(c) Environmental Engineering

Committee (EEC): ‘‘Commentary on

Measures of Environmental Technology

Performance.’’

Availability of Review Materials—

Drafts of the reports that will be

reviewed at the meeting should be

available to the public at the SAB

website (http://www.epa.gov/sab) by

close-of-business on May 25, 2000.

FOR FURTHER INFORMATION CONTACT: Any

member of the public wishing further

information concerning this meeting or

wishing to submit brief oral comments

must contact Dr. Donald Barnes,

Designated Federal Officer, Science

Advisory Board (1400A), U.S.

Environmental Protection Agency, 1200

Pennsylvania Avenue, NW, Washington,

DC 20460; telephone (202) 564–4533;

FAX (202) 501–0323; or via e-mail at

barnes.don@epa.gov. Requests for oral

comments must be in writing (e-mail

preferred) and received by Dr. Barnes no

later than noon Eastern Time on June 5,

2000.

Providing Oral or Written Comments at

SAB Meetings

It is the policy of the Science

Advisory Board to accept written public

comments of any length, and to

accommodate oral public comments

whenever possible. The Science

Advisory Board expects that public

statements presented at its meetings will

not be repetitive of previously

submitted oral or written statements.

Oral Comments: In general, each

individual or group requesting an oral

presentation at a face-to-face meeting

will be limited to a total time of ten

minutes. For teleconference meetings,

opportunities for oral comment will

usually be limited to no more than three

minutes per speaker and no more than

fifteen minutes total. Deadlines for

getting on the public speaker list for a

meeting are given above. Speakers

should bring at least 35 copies of their

comments and presentation slides for

distribution to the reviewers and public

at the meeting. Written Comments:

Although the SAB accepts written

comments until the date of the meeting

(unless otherwise stated), written

comments should be received in the

SAB Staff Office at least one week prior

to the meeting date so that the

comments may be made available to the

committee for their consideration.

Comments should be supplied to the

appropriate DFO at the address/contact

information noted above in the

following formats: One hard copy with

original signature, and one electronic

copy via e-mail (acceptable file format:

WordPerfect, Word, or Rich Text files

(in IBM-PC/Windows 95/98 format).

Those providing written comments and

who attend the meeting are also asked

to bring 25 copies of their comments for

public distribution.

General Information—Additional

information concerning the Science

Advisory Board, its structure, function,

and composition, may be found on the

SAB Website (http://www.epa.gov/sab)

and in The FY1999 Annual Report of

the Staff Director which is available

from the SAB Publications Staff at (202)

564–4533 or via fax at (202) 501–0256.

Committee rosters, draft Agendas and

meeting calendars are also located on

our website.

Meeting Access—Individuals

requiring special accommodation at this

meeting, including wheelchair access to

the conference room, should contact the

DFO at least five business days prior to

the meeting so that appropriate

arrangements can be made.

Dated: May 5, 2000.

Donald G. Barnes,

Staff Director, Science Advisory Board.

[FR Doc. 00–12021 Filed 5–11–00; 8:45 am]

BILLING CODE 6560–50–P

ENVIRONMENTAL PROTECTION

AGENCY

[PF–926; FRL–6497–1]

Notice of Filing Pesticide Petitions to

Establish a Tolerance for Certain

Pesticide Chemicals 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 certain

pesticide chemicals in or on various

food commodities.

DATES: Comments, identified by docket

control number PF–914, must be

received on or before June 12, 2000.

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–926 in the subject line on the first

page of your response.

FOR FURTHER INFORMATION CONTACT: By

mail: Tracy Keigwin, Registration

Division (7505C), Office of Pesticide

Programs, Environmental Protection

Agency, Ariel Rios Bldg., 1200

Pennsylvania Ave., NW., Washington,

DC 20460; telephone number: (703)

305–6605; e-mail address:

keigwin.tracy@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:

CategoriesNAICS

codes

Examples of potentially affected entities

Industry 111 Crop production

112 Animal production

30592 Federal Register / Vol. 65, No. 93 / Friday, May 12, 2000 / Notices

CategoriesNAICS

codes

Examples of potentially affected entities

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’’ 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–

926. 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

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 (CM #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–926 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, Ariel Rios Bldg., 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, CM #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–926. 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 Comestic 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 supports 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: May 2, 2000.

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

Federal Register / Vol. 65, No. 93 / Friday, May 12, 2000 / Notices 30593

was prepared by the petitioner and

represents the view of the petitioners.

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.

Zeneca Ag Products

0F6092

EPA has received a pesticide petition

(0F6092) from Zeneca Ag Products,

1800 Concord Pike, P.O. Box 15458,

Wilmington, DE, 19850–5458 proposing,

pursuant to section 408(d) of FFDCA, 21

U.S.C. 346a(d), to amend 40 CFR part

180.438, by establishing a tolerance for

residues of lambda-cyhalothrin, (S)-

alpha-cyano-3-phenoxybenzyl- (Z)-

(1R,3R)-3-(2-chloro-3,3,3-trifluoroprop1-enyl)-2, 2-

dimethylcyclopropanecarboxylate and

(R)-alpha-cyano-3-phenoxybenzyl- (Z)-

(1S,3S)-3-(2-chloro-3,3,3-trifluoroprop1-enyl)-2, 2-

dimethylcyclopropanecarboxylate and

the epimer of lambda-cyhalothrin, (S)-

alpha-cyano-3-phenoxybenzyl- (Z)-

(1S,3S)-3-(2-chloro-3,3,3-trifluoroprop1-enyl)-2, 2-

dimethylcyclopropanecarboxylate and

(R)-alpha-cyano-3-phenoxybenzyl- (Z)-

(1R,3R)-3-(2-chloro-3,3,3-trifluoroprop1-enyl)-2, 2-

dimethylcyclopropanecarboxylate in or

on the raw agricultural commodities

(RAC) canola seed, almond hulls, and

the crop groupings pome fruit, stone

fruit and tree nuts at 0.15, 1.5, 0.3, 0.5,

0.05 parts per million (ppm),

respectively, and on the processed

commodity apple pomace, wet at 2.5

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 supports

granting of the petition. Additional data

may be needed before EPA rules on the

petition.

A. Residue Chemistry

1. Plant metabolism. The metabolism

of lambda-cyhalothrin has been studied

in cotton, soybean, cabbage and wheat

plants. The studies show that the

metabolism generally follows that of

other pyrethroid insecticides. The ester

linkage is cleaved to form

cyclopropanecarboxylic acids and the

corresponding phenoxybenzyl alcohol.

Overall the studies show that

unchanged lambda-cyhalothrin is the

principal constituent of the residue on

edible portions of these crops.

2. Analytical method. An adequate

analytical method (gas liquid

chromatography with an electron

capture detector) is available for

enforcement purposes.

3. Magnitude of residues. Crop field

trial residue data from canola, pome

fruit, stone fruit and tree nuts studies

show that the proposed tolerances on

these commodities will not be exceeded

when lambda-cyhalothrin is used as

directed. A market basket survey of

residues of lambda-cyhalothrin in

samples of whole milk collected across

the contiguous United States over a

period of 1 year was conducted during

1998–99. Nearly 80% of the 360

samples collected had non-detectable

(<0.0003 μg/L) levels of lambdacyhalothrin with the remaining 20%

having trace levels (<0.001 μg/L). These

levels are substantially less than the

established tolerance for whole milk of

0.2 milligrams/kilograms (mg/kg).

No increase in the dietary burden of

poultry and ruminants is expected from

use on canola, pome fruit, stone fruit, or

tree nuts. Therefore, any secondary

residues that might result in milk, meat,

poultry, and eggs would be covered by

the existing tolerances on these

commodities.

B. Toxicological Profile

1. Acute toxicity. Acute toxicity

studies with the technical grade of the

active ingredient lambda-cyahothrin:

oral lethel dose (LD)50 in the rat of 79

mg/kg (males) and 56 mg/kg (females),

dermal LD50 in the rat of 632 mg/kg

(males) and 696 mg/kg females, primary

eye irritation study showed mild

irritation and primary dermal irritation

study showed no irritation.

2. Genotoxicty. The following

genotoxicity tests were all negative: a

gene mutation assay (Ames), a mouse

micronucleus assay, an in vitro

cytogenetics assay, and a gene mutation

study in mouse lymphoma cells.

3. Reproductive and developmental

toxicity. A 3-generation reproduction

study in rats fed diets containing 0, 10,

30, and 100 ppm with no developmental

toxicity observed at 100 ppm, the

highest dose tested. The maternal

NOAEL (no observed adverse effect

level) and LOAEL (lowest observed

adverse effect level) for the study are

established at 30 (1.5 mg/kg/day) and

100 ppm (5 mg/kg/day), respectively,

based upon decreased parental body

weight gain. The reproductive NOAEL

and LOAEL are established at 30 (1.5

mg/kg/day) and 100 ppm (5 mg/kg/day),

respectively, based on decreased pup

weight gain during weaning.

A developmental toxicity study in rats

given gavage doses of 0, 5, 10, and 15

mg/kg/day with no developmental

toxicity observed under the conditions

of the study. The developmental

NOAEL is greater than 15 mg/kg/day,

the highest dose tested. The maternal

NOAEL and LOAEL are established at

10 and 15 mg/kg/day, respectively,

based on reduced body weight gain.

A developmental toxicity study in

rabbits given gavage doses of 0, 3, 10,

and 30 mg/kg/day with no

developmental toxicity observed under

the conditions of the study. The

maternal NOAEL and LOAEL are

established at 10 and 30 mg/kg/day,

respectively based on decreased body

weight gain. The developmental NOAEL

is greater than 30 mg/kg/day, the highest

dose tested.

4. Subchronic toxicity. A 90-day

feeding study in rats fed doses of 0, 10,

50 and 250 ppm with a NOAEL of 50

ppm and a LOAEL of 250 ppm based on

body weight gain reduction.

A study where lambda-cyhalothrin in

olive oil was applied to the skin of rats

for 21 successive days at dose rates of

1, 10, or 100 (reduced to 50 after 2–3

applications) mg/kg/day. A NOAEL of

10 mg/kg/day is based on clinical signs

of slight general toxicity at 50 mg/kg/

day.

5. Chronic toxicity. A 12-month

feeding study in dogs fed dose (by

capsule) levels of 0, 0.1, 0.5, 3.5 mg/kg/

day with a NOAEL of 0.1 mg/kg/day.

The LOAEL for this study is established

at 0.5 mg/kg/day based upon clinical

signs of neurotoxicity.

A 24-month chronic feeding/

carcinogenicity study with rats fed diets

containing 0, 10, 50, and 250 ppm. The

NOAEL was established at 50 ppm and

LOAEL at 250 ppm based on reduced

body weight gain. There were no

carcinogenic effects observed under the

conditions of the study.

A carcinogenicity study in mice fed

dose levels of 0, 20, 100, or 500 ppm (0,

3, 15, or 75 mg/kg/day) in the diet for

2 years. A systemic NOAEL was

established at 100 ppm and systemic

LOAEL at 500 ppm based on decreased

body weight gain in males throughout

the study at 500 ppm. The Agency has

classified lambda-cyhalothrin as a

Group D carcinogen (not classifiable due

to an equivocal finding in this study). It

is Zeneca’s position that no treatmentrelated carcinogenic effects were

observed under the conditions of the

study.

6. Animal metabolism. Metabolism

studies in rats demonstrated that

distribution patterns and excretion rates

30594 Federal Register / Vol. 65, No. 93 / Friday, May 12, 2000 / Notices

in multiple oral dose studies are similar

to single-dose studies. Accumulation of

unchanged compound in fat upon

chronic administration with slow

elimination was observed. Otherwise,

lambda-cyhalothrin was rapidly

metabolized and excreted. The

metabolism of lambda-cyhalothrin in

livestock has been studied in the goat,

chicken, and cow. Unchanged lambdacyhalothrin is the major residue

component of toxicological concern in

meat and milk.

Human metabolism of lambdacyhalothrin was assessed by

administering 5 mg lambda-cyhalothrin

orally to six male volunteers (average

dose was 0.06 mg/kg) and dermally at

20 mg/800 centimeters2 to five

volunteers. No adverse effects were

noted in the individuals given an oral

dose, and only mild signs of parasthesia

were noted in individuals receiving a

dermal dose. Absorption by these two

routes of exposure were determined by

analysis of urinary metabolites. An

average amount of 59% of the oral dose

was absorbed. Dermal absorption was

extremely low, and estimated to be

0.12% (range 0.04–0.19%).

7. Metabolite toxicology. The Agency

has previously determined that the

metabolites of lambda-cyhalothrin are

not of toxicological concern and need

not be included in the tolerance

expression. Given this determination, it

is concluded that there is no need to

discuss metabolite toxicity.

8. Endocrine disruption. EPA is

required to develop a screening program

to determine whether certain substances

(including all pesticides and inerts)

‘‘may have an effect in humans that is

similar to an effect produced by a

naturally occurring estrogen, or such

other endocrine effect * * *’’ The

Agency is currently working with

interested stakeholders, including other

government agencies, public interest

groups, industry and research scientists

in developing a screening and testing

program and a priority setting scheme to

implement this program. Congress has

allowed 3 years from the passage of

FQPA (August 3, 1999) to implement

this program. At that time, EPA may

require further testing of this active

ingredient and end use products for

endocrine disrupter effects.

C. Aggregate Exposure

1. Dietary exposure. For the purposes

of assessing the potential chronic

dietary exposure for all existing and

pending tolerances for lambdacyhalothrin, Zeneca has utilized

available information on anticipated

residues (FDA monitoring data, average

field trial residues and processing data)

and percent crop treated. For the acute

dietary assessment, a Monte Carlo

method was used to estimate exposure.

i. Food —a. Acute dietary exposure.

An acute dietary exposure assessment

was made using the dietary exposure

evaluation model (DEEM) computer

software (Novigen Sciences Inc.) and the

USDA Continuing Surveys of Individual

Intakes (CSFII) 1994–96. Acute dietary

exposure was based on all crops with

tolerances for lambda-cyhalothrin

established at 40 CFR 180.438 together

with crops in this petition, canola, and

the crop groupings pome fruit, stone

fruit and tree nuts. Anticipated residues

were estimated from field trial data and

from the lambda-cyhalothrin national

milk survey together with estimates of

percent crop treated for each crop. The

predicted acute exposure for the U.S.

population was 0.001269 mg/kg/body

weight/day (mg/kg/bwt/day). The

population subgroup with the highest

predicted level of acute exposure was

non-nursing infants (<1 year old) with

an exposure of 0.003599 mg/kg/bwt/day

(99.9th percentile). Based on an acute

NOAEL of 0.5 mg/kg/bwt/day from a 1-

year dog feeding study, and a 100–fold

safety factor, the acute reference dose

(aRfD) is 0.005 mg/kg/bwt/day. For the

U.S. population the predicted exposure

is equivalent to 25% of the aRfD. For the

population subgroup non-nursing

infants (<1 year old) the exposure is

equivalent to 72% of the aRfD. Because

the predicted exposures, expressed as

the percentages of the aRfD, are well

below 100%, there is reasonable

certainty that no acute effects would

result from the dietary exposure to

lambda-cyhalothrin.

b. Chronic dietary exposure. A

chronic dietary exposure assessment

was made using the DEEM computer

software (Novigen Sciences Inc.).

Chronic dietary exposure was based on

all crops with tolerances for lambdacyhalothrin established at 40 CFR

180.438 together with crops in this

petition, canola, and the crop groupings

pome fruit, stone fruit and tree nuts.

Anticipated residues were estimated

from field trial data and from the

lambda-cyhalothrin national milk

survey together with estimates of

percent crop treated for each crop. The

predicted chronic exposure for the U.S.

population was 0.000062 mg/kg/bwt/

day. The population subgroup with the

highest predicted level of chronic

exposure was non-nursing infants with

an exposure of 0.000132 mg/kg/bwt/

day. Based on a chronic NOAEL of 0.1

mg/kg/bwt/day from a 1-year dog

feeding study, and a 100-fold safety

factor, the chronic reference dose (cRfD)

is 0.001 mg/kg/bwt/day. For the U.S.

population the predicted exposure is

equivalent to 6.2% of the cRfD. For the

population subgroup non-nursing

infants the exposure is equivalent to

13.2% of the cRfD. Because the

predicted exposures, expressed as the

percentages of the aRfD, are well below

100%, there is reasonable certainty that

no chronic effects would result from the

dietary exposure to lambda-cyhalothrin.

ii. Drinking water. Laboratory and

field data have demonstrated that

lambda-cyhalothrin and its degradates

are immobile in soil and will not leach

into ground water. Surface water

estimates were made by EPA using the

GENEEC model (Tier I). The predicted

peak, average and annual values (56

days) are, respectively, 0.095 parts per

billion (ppb), 0.003 ppb and <0.003 ppb.

EPA uses drinking water levels of

comparison (DWLOCs) as a surrogate

measure to capture risk associated with

exposure to pesticides in drinking

water. A DWLOC is the concentration of

a pesticide in drinking water that would

be acceptable as an upper limit in light

of total aggregate exposure to that

pesticide from food, water, and

residential uses. A DWLOC will vary

depending on the residue level in foods,

the toxicity endpoint and with drinking

water consumption patterns and body

weights for specific subpopulations. The

acute DWLOC for lambda-cyhalothrin

was calculated for the subpopulation of

concern, non-nursing infants (<1 year

old), to be 14 ppb. The chronic DWLOC

was calculated for this subpopulation to

be 9 ppb. The predicted maximum

concentration of lambda-cyhalothrin in

drinking water is 0.095 ppb which is

much lower than the acute DWLOC.

Therefore one can conclude with

reasonable certainty that residues of

lambda-cyhalothrin do not contribute

significantly to the aggregate acute

human health risk. The chronic DWLOC

for the most sensitive subpopulation,

non-nursing infants (<1 year old), is 9

ppb. This DWLOC is substantially

higher than the predicted average

concentration of lambda-cyhalothrin in

surface water of 0.003 ppb. Therefore

one can conclude with reasonable

certainty that residues of lambdacyhalothrin do not contribute

significantly to the aggregate chronic

human health risk.

2. Non-dietary exposure. Other

potential sources of exposure are from

non-occupational sources such as

structural pest control and ornamental

plant and lawn use of lambdacyhalothrin. A risk assessment was

performed by EPA published in the

Federal Register January 29, 1999 (64

FR 4584) (FRL–6056–2), for post

application activities on lawns treated

Federal Register / Vol. 65, No. 93 / Friday, May 12, 2000 / Notices 30595

with lambda-cyhalothrin which is

considered to be a worse case estimate

of exposure from residential uses.

Results from EPA’s short-term exposure

and risk assessments showed that the

oral MOE (margin of exposure) for

infants and children was 3,500, the

dermal MOEs were 1.5 million for the

U.S. population and 7,810 for infants

and children, and the inhalation MOEs

were 15,000 for the U.S. population and

4,800 for infants and children. For

intermediate-term exposure and risk

assessments, EPA concluded the oral

MOEs for infants and children was 700,

the dermal MOEs were 1.5 million for

the U.S. population and 7,810 for

infants and children, and the inhalation

MOEs were 15,000 for the U.S.

population and 4,800 for infants and

children. EPA concludes that there is a

reasonable certainty of no harm for

MOEs of 100 or greater. Therefore, the

non-dietary and overall aggregate risk

assessments for lambda-cyhalothrin

clearly indicates a reasonable certainty

of no harm.

D. Cumulative Effects

Zeneca Ag Products will submit

information for EPA to consider

concerning potential cumulative effects

of lambda-cyhalothrin consistent with

the schedule established by EPA in the

Federal Register of August 4, 1997 (62

FR 42020) (FRL–5734–6), and other EPA

publications pursuant to the Food

Quality Protection Act. At this time,

Zeneca cannot make a determination

based on available and reliable

information that lambda-cyhalothrin

and other substances that may have a

common mechanism of toxicity would

have cumulative effects. Therefore for

purposes of this request it is appropriate

only to consider the potential risks of

lambda-cyhalothrin in an aggregate

exposure assessment.

E. Safety Determination

1. U.S. population. Based on the

completeness and reliability of the

lambda-cyhalothrin toxicology data base

and using the conservative aggregate

exposure assumptions presented earlier,

it is concluded that lambda-cyhalothrin

products may be used with a reasonable

certainty of no harm relative to

exposures from food and drinking

water. A chronic dietary exposure and

risk assessment has been performed for

lambda-cyhalothrin using EPA’s cRfD of

0.001 mg/kg/bwt/day. Available

information on anticipated residues,

monitoring data and percent crop

treated was incorporated into the

analysis to estimate the Anticipated

Residue Contribution (ARC). The ARC is

generally considered a more realistic

estimate than an estimate based on

tolerance level residues. The ARC from

established tolerances and the current

and pending actions are estimated to be

0.000062 mg/kg/bwt/day and utilize

6.2% of the cRfD. An acute dietary

exposure and risk assessment has been

performed for lambda-cyhalothrin using

EPA’s aRfD of 0.005 mg/kg/bwt/day.

The ARC from established tolerances

and the current and pending actions are

estimated to be 0.001269 and utilize

25% of the aRfD. The acute and chonic

DWLOC for lambda-cyhalothrin for the

U.S. population are 131 ppb and 33 ppb,

respectively. The maximum

concentrations in drinking water

predicted by EPA are substantially

lower than either the acute or chronic

DWLOC. Therefore, one can conclude

with reasonable certainty that residues

of lambda-cyhalothrin in drinking water

would not contribute significantly to the

aggregate acute or chronic human health

risk. In conclusion, there is a reasonable

certainty of no harm to the general

population resulting from either acute

or chronic aggregate exposure to

lambda-cyhalothrin.

2. Infants and children. FFDCA

section 408 provides that EPA shall

apply an additional ten-fold 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 unless

EPA determines that a different margin

of safety will be safe for infants and

children. EPA generally defines the

level of appreciable risk as exposure

that is greater than 1/100 of the NOAEL

in the animal study appropriate to the

particular risk assessment. This

hundred-fold uncertainty (safety) factor/

margin of exposure is designed to

account for combined interspecies and

intraspecies variability. EPA believes

that reliable data support using the

standard hundred-fold margin/factor

and not the additional tenfold margin/

factor when EPA has a complete data

base under existing guidelines and

when the severity of the effect in infants

and children or the potency or unusual

toxic properties of a compound do not

raise concerns regarding the adequacy of

the standard margin/factor.

In assessing the potential for

additional sensitivity of infants and

children to residues of lambdacyhalothrin, EPA considered the data

from oral developmental toxicity studies

in the rat and rabbit, as well as data

from a multi-generation reproduction

study in the rat. The developmental

toxicity studies are designed to evaluate

adverse effects in the developing

organism resulting from pesticide

exposure during prenatal development

in the mothers. Reproduction studies

provide information relating to effects

from exposure to the pesticide on the

reproductive capability of mating

animals and data on systemic toxicity.

3. Prenatal effects. A developmental

toxicity study in rats given gavage doses

of 0, 5, 10, and 15 mg/kg/day with no

developmental toxicity observed under

the conditions of the study. The

developmental NOAEL is greater than

15 mg/kg/day, the highest dose tested.

The maternal NOAEL and LOAEL are

established at 10 and 15 mg/kg/day,

respectively, based on reduced body

weight gain.

A developmental toxicity study in

rabbits given gavage doses of 0, 3, 10,

and 30 mg/kg/day with no

developmental toxicity observed under

the conditions of the study. The

maternal NOAEL and LOAEL are

established at 10 and 30 mg/kg/day,

respectively based on decreased body

weight gain. The developmental NOAEL

is greater than 30 mg/kg/day, the highest

dose tested.

4. Postnatal effects. A 3–generation

reproduction study in rats fed diets

containing 0, 10, 30, and 100 ppm with

no developmental toxicity observed at

100 ppm, the highest dose tested. The

maternal NOAEL and LOAEL for the

study are established at 30 (1.5 mg/kg/

day) and 100 ppm (5 mg/kg/day),

respectively, based upon decreased

parental body weight gain. The

reproductive NOAEL and LOAEL are

established at 30 (1.5 mg/kg/day) and

100 ppm (5 mg/kg/day), respectively,

based on decreased pup weight gain

during weaning.

EPA have concluded in its 1997

review of lambda-cyhalothrin that the

toxicity endpoints from the data on

developmental and reproductive

toxicity tests do not indicate any

increased prenatal or postnatal

sensitivity. Therefore, EPA concluded

that reliable data support use of a

hundred fold safety factor and that an

additional tenfold safety factor is not

needed.

Based on this information, the ARC

for children aged 1 to 6 years old, and

non-nursing infants (subgroups most

highly exposed) utilizes 0.000127 mg/

kg/bwt/day (12.7% of the cRfD) and

0.000132 mg/kg/bwt/day (13.2% of the

cRfD), respectively. Generally speaking,

the Agency has no cause for concern if

the anticipated residues contribution for

all published and proposed tolerances is

less than the 100% of the cRfD.

For the acute dietary assessment the

ARC for children aged 1 to 6 years old,

and non-nursing infants (subgroups

most highly exposed) utilizes 0.002363

mg/kg/bwt/day (47.3% of the aRfD) and

30596 Federal Register / Vol. 65, No. 93 / Friday, May 12, 2000 / Notices

0.003599 mg/kg/bwt/day (72% of the

aRfD), respectively. Generally speaking,

the Agency has no cause for concern if

the anticipated residues contribution for

all published and proposed tolerances is

less than the 100% of the aRfD. The

acute and chonic DWLOC for lambdacyhalothrin for non-nursing infants are

14 ppb and 9 ppb, respectively. The

maximum concentrations in drinking

water predicted by EPA are

substantially lower than either the acute

or chronic DWLOC. Based on these

exposure estimates it may be concluded

that there is a reasonable certainty that

no harm will result to infants and

children from aggregate exposures to

lambda-cyhalothrin.

F. International Tolerances

There are Codex maximum residue

levels (MRL) established or pending for

residues of cyhalothrin, as the sum of all

isomers, in or on the following crops

and commoditites.

Crop MRL (mg/kg)

Apricots ..................... 0.2

Cabbage, head ......... 0.2

Cherries ..................... 0.2

Cotton seed ............... 0.02

Cotton seed, oil ......... 0.02

Oil seed (including

rapeseed oil).

0.02

Peaches .................... 0.2

Plums ........................ 0.1

Pome fruit .................. 0.1

Potatoes .................... 0.02

Tree nuts (shelled

and unshelled).

0.05

Canadian MRLs of 0.1 ppm for pome

fruit, stone fruit and canola are

established in Canada for lambdacyhalothrin based on the ‘‘negligble’’

residue clause of Canadian Food & Drug

Act Regulations (B.15.002(1)).

[FR Doc. 00–11871 Filed 5–11–00; 8:45 am]

BILLING CODE 6560–50–F

FEDERAL COMMUNICATIONS

COMMISSION

Notice of Public Information

Collection(s) Being Reviewed by the

Federal Communications Commission,

Comments Requested

May 3, 2000.

SUMMARY: The Federal Communications

Commission, as part of its continuing

effort to reduce paperwork burden

invites the general public and other

Federal agencies to take this

opportunity to comment on the

following information collection, as

required by the Paperwork Reduction

Act of 1995, Public Law 104–13. An

agency may not conduct or sponsor a

collection of information unless it

displays a currently valid control

number. No person shall be subject to

any penalty for failing to comply with

a collection of information subject to the

Paperwork Reduction Act (PRA) that

does not display a valid control number.

Comments are requested concerning (a)

whether the proposed collection of

information is necessary for the proper

performance of the functions of the

Commission, including whether the

information shall have practical utility;

(b) the accuracy of the Commission’s

burden estimate; (c) ways to enhance

the quality, utility, and clarity of the

information collected; and (d) ways to

minimize the burden of the collection of

information on the respondents,

including the use of automated

collection techniques or other forms of

information technology.

DATES: Written comments should be

submitted on or before July 11, 2000. If

you anticipate that you will be

submitting comments, but find it

difficult to do so within the period of

time allowed by this notice, you should

advise the contact listed below as soon

as possible.

ADDRESSES: Direct all comments to Les

Smith, Federal Communications

Commission, 445 12th Street, SW.,

Room 1–A804, Washington, DC 20554

or via the Internet to lesmith@fcc.gov.

FOR FURTHER INFORMATION CONTACT: For

additional information or copies of the

information collections contact Les

Smith at (202) 418–0217 or via the

Internet at lesmith@fcc.gov.

SUPPLEMENTARY INFORMATION:

OMB Approval Number: 3060–0783.

Title: Section 90.176 Coordination

notification requirements on frequencies

below 512 MHz.

Form Number: N/A.

Type of Review: New collection.

Respondents: Business or other forprofit.

Number of Respondents: 15.

Estimated Time Per Response: .25

hours.

Total Annual Burden: 975 hours.

Total Annual Cost: 0.

Needs and Uses: The reporting

requirement in section 90.176 is a result

of comments sought in the Report and

Order and Further Notice of Proposed

Rule Making in PR Dck No. 92–235 and

requires each Private Land Mobile

frequency coordinator provide, within

one business day, a listing of their

frequency recommendations to all other

frequency coordinators in their

respective pool, and, if requested, an

engineering analyses. This requirement

is necessary to avoid situations where

harmful interference is created because

two or more coordinators recommend

the same frequency in the same area at

approximately the same time to

different applicants.

OMB Approval Number: 3060–0798.

Title: FCC Application for Wireless

Telecommunications Bureau Radio

Service Authorization.

Form Number: FCC 601.

Type of Review: Revision of an

existing collection.

Respondents: Individuals or

households; Business or other for-profit;

Not-for-profit institutions; State, Local

or Tribal Government.

Number of Respondents: 240,320.

Estimated Time Per Response: 1.25

hours.

Total Annual Burden: 210,280 hours.

Needs and Uses: FCC 601 is used as

the general application (long form) for

market based licensing and site-by-site

licensing in the Wireless

Telecommunications Radio Services.

The purpose of this revision is to make

the necessary changes for the 700 MHz

Band and 700 MHz Guard Band

Auctions and to convert the Land

Mobile Services (Part 90) to ULS. We

sought emergency clearance on these

changes in order to allow form changes

to be in place for the auctions scheduled

for the beginning of June and are now

seeking a 3 year clearance. The

information is used by the Commission

to determine whether the applicant is

legally, technically and financially

qualified to be licensed.

Respondent costs are estimated to be

$48,364,000, which includes

application filing fees.

OMB Control Number: 3060–0773.

Title: Marketing of RF Devices Prior to

Equipment Authorization—Section

2.830.

Form Number: N/A.

Type of Review: Extension of

currently approved collection.

Respondents: Businesses or other forprofit entities.

Number of Respondents: 6,000.

Estimated Time Per Response: .5

hour.

Total Annual Burden: 3,000 hours.

Total Annual Cost: N.A.

Needs and Uses: FCC rules permit the

display and advertising of radio

frequency devices prior to equipment

authorization or a determination of

compliance with the rules, providing

that the advertising or display contains

a conspicuous notice as specified by the

rules. The notice that must be displayed

is defined in section 2.803. A notice

that applies specifically to prototype

equipment is defined in section