66998 Federal Register / Vol. 65, No. 217 / Wednesday, November 8, 2000 / Notices

Office of Pesticide Programs,

Environmental Protection Agency, 1200

Pennsylvania Ave., NW., Washington,

DC 20460; telephone number: (703)

308–8174; e-mail address:

chambliss.ben@epa.gov.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does This Action Apply to Me?

This action applies to the public in

general. As such, the Agency has not

attempted to specifically describe all the

entities potentially affected by this

action. The Agency believes that a wide

range of stakeholders will be interested

in technical briefings on

organophosphate pesticides, including

environmental, human health, and

agricultural advocates, the chemical

industry, pesticide users, and members

of the public interested in the use of

pesticides on food. If you have any

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 Registerlistings at http://

www.epa.gov/fedrgstr/.

To access information about

organophosphate pesticides, you can

also go directly to the Home Page for the

Office of Pesticide Programs (OPP) at

http://www.epa.gov/pesticides/op/. In

addition, a brief summary of the

diazinon revised risk assessment is now

available at http://www.epa.gov/

pesticides/op/status.htm/, as well as in

paper as part of the public version of the

official record as described in Unit I.B.2.

2. In person. The Agency has

established an official record under

docket control number OPP–34225A.

The official record consists of the

documents specifically referenced in

this action, 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, 1921 Jefferson Davis Hwy.,

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.

II. What Action is the Agency Taking?

This document announces the

Agency’s intention to hold a technical

briefing for the organophosphate

pesticide, diazinon. The Agency is

presenting the revised risk assessments

for diazinon to interested stakeholders.

This technical briefing is designed to

provide stakeholders with an

opportunity to become even more

informed about an organophosphate’s

risk assessment. EPA will describe in

detail the revised risk assessment:

Including the major points (e.g.,

contributors to risk estimates); how

public comment on the preliminary risk

assessment affected the revised risk

assessment; and the pesticide use

information/data that was used in

developing the revised risk assessment.

Stakeholders will have an opportunity

to ask clarifying questions. In addition,

representatives of the USDA will

provide ideas on possible risk

management.

The technical briefing is part of the

pilot public participation process that

EPA and USDA are now using for

involving the public in the reassessment

of pesticide tolerances under the Food

Quality Protection Act (FQPA), and the

reregistration of individual

organophosphate pesticides under the

Federal Insecticide, Fungicide, and

Rodenticide Act (FIFRA). The pilot

public participation process was

developed as part of the EPA-USDA

Tolerance Reassessment Advisory

Committee (TRAC), which was

established in April 1998 as a

subcommittee under the auspices of

EPA’s National Advisory Council for

Environmental Policy and Technology.

A goal of the pilot public participation

process is to find a more effective way

for the public to participate at critical

junctures in the Agency’s development

of organophosphate pesticide risk

assessment and risk management

decisions. EPA and USDA began

implementing this pilot process in

August 1998 in response to Vice

President Gore’s directive to increase

transparency and opportunities for

stakeholder consultation.

On the day of the technical briefing,

in addition to making copies available at

the meeting site, the Agency will also

release for public viewing the diazinon

revised risk assessments and related

documents to the Public Information

and Records Integrity Branch and the

OPP Internet web site that are described

in Unit I.B.1. In addition, the Agency

will issue a Federal Register notice to

provide an opportunity for a 60–day

public participation period during

which the public may submit risk

management and mitigation ideas and

recommendations and proposals for

transition.

List of Subjects

Environmental protection, Chemicals,

Pesticides and pests.

Dated: October 24, 2000.

Jack E. Housenger,

Acting Director, Special Review and

Reregistration Division, Office of Pesticide

Programs.

[FR Doc. 00–28422 Filed 11–07–00; 8:45 am]

BILLING CODE 6560–50–S

ENVIRONMENTAL PROTECTION

AGENCY

[PF–980; FRL–6750–2]

Notice of Filing Pesticide Petitions to

Establish Tolerances for Certain

Pesticide Chemicals in or on Food

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Notice.

SUMMARY: This notice announces the

initial filing of pesticide petitions

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–980, must be

received on or before December 8, 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–980 in the subject line on the first

page of your response.

FOR FURTHER INFORMATION CONTACT: By

mail: Linda DeLuise, Registration

Division (7505C), Office of Pesticide

Programs, Environmental Protection

Agency, 1200 Pennsylvania Ave., NW.,

Federal Register / Vol. 65, No. 217 / Wednesday, November 8, 2000 / Notices 66999

Washington, DC 20460; telephone

number: (703) 305–5428; e-mail address:

deluise.linda@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

Eamples of potentially affected

entities

Industry 111 Crop production

.............. 112 Animal production

.............. 311 Food manufacturing

.............. 32532 Pesticide manufacturing

This listing is not intended to be

ehaustive, 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–

980. 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, 1921 Jefferson Davis Highway,

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

Monday through Friday, ecluding 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–980 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, ecluding 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–980. 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 ecept 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. Eplain 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, eplain how you arrived at the

estimate that you provide.

5. Provide specific eamples 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 pesticide petitions

as follows proposing the establishment

and/or amendment of regulations for

residues of certain pesticide chemicals

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

these petitions contain 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

petitions. Additional data may be

needed before EPA rules on the

petitions.

67000 Federal Register / Vol. 65, No. 217 / Wednesday, November 8, 2000 / Notices

List of Subjects

Environmental protection,

Agricultural commodities, Feed

additives, Food additives, Pesticides

and pests, Reporting and recordkeeping

requirements.

Dated: October 25, 2000.

Peter Caulkins,

Acting Director, Registration Division, Office

of Pesticide Programs.

Summaries of Petitions

The petitioner summaries of the

pesticide petitions 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 petitions

summaries verbatim without editing it

in any way. The petitions summaries

announces the availability of a

description of the analytical methods

available to EPA for the detection and

measurement of the pesticide chemicals

residues or an eplanation of why no

such method is needed.

1. FMC Corporation

PP 0F6207

EPA has received a pesticide petition

PP 0F6207 from FMC Corporation, 1735

Market Street, Philadelphia, PA 19103

proposing, pursuant to section 408(d) of

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

40 CFR 180.418 by establishing

tolerances for residues of the insecticide

zeta-cypermethrin (±-a-Cyano(3-

phenoxyphenyl)methyl (±) cis, trans 3-

(2,2-dichloroethenyl)-2,2-

dimethylcyclopropanecarboxylate) in or

on the raw agricultural commodities

(RAC): wheat, grain at 0.15 parts per

million (ppm); wheat, forage, at 2.5

ppm; wheat, hay at 6.0 ppm; wheat,

straw at 6.5 ppm; wheat, bran at 0.20

ppm; sorghum, grain, at 0.50 ppm;

sorghum, forage at 0.10 ppm; sorghum,

fodder at 1.5 ppm; tomatoes at 0.10

ppm; peppers at 0.30 ppm; peas and

beans (dried, succulent, and edible

podded) at 0.50 ppm; soybeans at 0.05

ppm; poultry, meat at 0.05 ppm;

poultry, meat by-products at 0.05 ppm;

poultry, fat at 0.05 ppm and, eggs at 0.05

ppm; meat of cattle, goats, hogs, horses,

and, sheep at 0.3 ppm; fat of cattle,

goats, hogs, horses, and sheep at 0.30

ppm; and, milk, fat at 0.2 ppm

(reflecting 0.01 ppm in whole milk).

A. Residue Chemistry

1. Plant metabolism. The metabolism

of cypermethrin in plants is adequately

understood. Studies have been

conducted to delineate the metabolism

of radiolabelled cypermethrin in various

crops all showing similar results. The

residue of concern is the parent

compound only.

2. Analytical method. There is a

practical analytical method for detecting

and measuring levels of cypermethrin 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).

3. Magnitude of residues. Crop field

trial residue data from studies

conducted at the maimum label rates for

wheat, sorghum, peas, beans, soybeans,

tomatoes, and peppers show that the

proposed zeta-cypermethrin tolerances

on wheat, grain at 0.15 ppm; wheat,

forage, at 2.5 ppm; wheat, hay at 6.0

ppm; wheat, straw at 6.5 ppm; wheat,

bran at 0.20 ppm; sorghum, grain, at

0.50 ppm; sorghum, forage at 0.10 ppm;

sorghum, fodder at 1.5 ppm; tomatoes at

0.10 ppm; peppers at 0.30 ppm; peas,

and beans (dried, succulent, and edible

podded) at 0.50 ppm; soybeans at 0.05

ppm; will not be eceeded when the zetacypermethrin products labeled for these

uses are used as directed.

B. Toxicological Profile

1. Acute toxicity. For the purposes of

assessing acute dietary risk, FMC has

used the no observed adverse effect

level (NOAEL) of 10.0 milligrams/

kilograms (mg/kg)/day from the zetacypermethrin acute neurotoxicityy

study in rats. The lowest effect level

(LEL) of 50.0 mg/kg/day was based on

clinical signs. This acute dietary

endpoint is used to determine acute

dietary risks to all population

subgroups.

2. Genotoxicty. The following

genotoxicity tests were all negative: In

vivo chromosomal aberration in rat bone

marrow cells; in vitro cytogenic

chromosome aberration; unscheduled

DNA synthesis; chinese hampster ovary/

hypoanthine guanine phophoribosyl

transferase (CHO/HGPRT) mutagen

assay; weakly mutagenic; gene mutation

(Ames).

3. Reproductive and developmental

toxicity. No evidence of additional

sensitivity to young rats was observed

following prenatal or postnatal exposure

to zeta-cypermethrin.

i. A 2–-generation reproductive

toxicity study with zeta-cypermethrin in

rats demonstrated a NOAEL of 7.0 mg/

kg/day and a LOAEL of 27.0 mg/kg/day

for parental/systemic toxicity based on

body weight, organ weight, and clinical

signs. There were no adverse effects in

reproductive performance. The NOAEL

for reproductive toxicity was considered

to be ≤45.0 mg/kg/day (the highest dose

tested).

ii. A developmental study with zetacypermethrin in rats demonstrated a

maternal NOAEL of 12.5 mg/kg/day and

a LOAEL of 25 mg/kg/day based on

decreased maternal body weight gain,

food consumption and clinical signs.

There were no signs of developmental

toxicity at 35.0 mg/kg/day, the highest

dose level tested.

iii. A developmental study with

cypermethrin in rabbits demonstrated a

maternal NOAEL of 100 mg/kg/day and

a LOAEL of 450 mg/kg/day based on

decreased body weight gain. There were

no signs of developmental toxicity at

700 mg/kg/day, the highest dose level

tested.

4. Subchronic toxicity. Short- and

intermediate-term toxicity. The NOAEL

of 10.0 mg/kg/day based on clinical

signs at the LEL of 50.0 mg/kg/day in

the zeta-cypermethrin acute

neurotoxicity study in rats would also

be used for short- and intermediate-term

MOE calculations (as well as acute,

discussed in (1) above).

5. Chronic toxicity— i. The reference

dose (RfD) of 0.005 mg/kg/day for zetacypermethrin is based on a NOAEL of

1.0 mg/kg/day from a cypermethrin dog

chronic study and an uncertainty factor

of 200 (used to account for the

differences in the percentage of the

biologically active isomer). The

endpoint effect of concern was based on

gastrointestinal disturbances.

ii. Cypermethrin is classified as a

Group C chemical (possible human

carcinogen with limited evidence of

carcinogenicity in animals) based upon

limited evidence for carcinogenicity in

female mice; assignment of a Q* has not

been recommended.

6. Animal metabolism. The

metabolism of cypermethrin in animals

is adequately understood. Cypermethrin

has been shown to be rapidly absorbed,

distributed, and excreted in rats when

administered orally. Cypermethrin is

metabolized by hydrolysis and oidation.

7. Metabolite toxicology. The Agency

has previously determined that the

metabolites of cypermethrin are not of

toxicological concern and need not be

included in the tolerance epression.

8. Endocrine disruption. No special

studies investigating potential

estrogenic or other endocrine effects of

cypermethrin have been conducted.

However, no evidence of such effects

were 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 cypermethrin

has an adverse effect on the endocrine

system.

Federal Register / Vol. 65, No. 217 / Wednesday, November 8, 2000 / Notices 67001

C. Aggregate exposure

1. Dietary exposure—i. Food.

Permanent tolerances, in support of

registrations, currently eist for residues

of zeta- cypermethrin on cottonseed,

pecans, lettuce, head, onions, bulb,

cabbage, and, livestock commodities of

cattle, goats, hogs, horses, and sheep

(along with the associated meat and

milk tolerances). For the purposes of

assessing the potential dietary exposure

for these eisting and the subject

proposed 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 one day or

single exposure. For the purposes of

assessing acute dietary risk for zetacypermethrin, FMC has used the

NOAEL of 10.0 mg/kg/day from the

zeta-cypermethrin acute neurotoxicity

study in rats. The LEL of 50.0 mg/kg/

day was based on clinical signs. This

acute dietary endpoint is 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 margins of exposure

(MOE) are significantly greater than the

EPA standard of 100 for all

subpopulations. The 95th percentile of

exposure for the overall U.S. population

was estimated to be 0.000630 mg/kg/day

(margin of exposure (MOE) of 15884);

99th percentile 0.002184 mg/kg/day

(MOE of 4577); and 99.9th percentile

0.010260 mg/kg/day (MOE of 974). The

95th percentile of exposure for all

infants <1 year old was estimated to be

0.000599 mg/kg/day (MOE of 16682);

99th percentile 0.005656 mg/kg/day

(MOE of 1768); and 99.9th percentile

0.029094 mg/kg/day (MOE of 343). The

95th percentile of exposure for nursing

infants < 1 year old was estimated to be

0.000172 mg/kg/day (MOE of 58054);

99th percentile 0.000967 mg/kg/day

(MOE of 10336); and 99.9th percentile

0.004937 mg/kg/day (MOE of 2025). The

95th percentile of exposure for nonnursing infants < 1 year old (the most

highly exposed population subgroup)

was estimated to be 0.000760 mg/kg/day

(MOE of 13155); 99th percentile

0.011082 mg/kg/day (MOE of 902); and

99.9th percentile 0.032957 mg/kg/day

(MOE of 303). The 95th percentile of

exposure for children 1 to 6 years old

and children 7 to 12 years old was

estimated to be, respectively, 0.000936

mg/kg/day (MOE of 10681) and

0.000644 mg/kg/day (MOE of 15524);

99th percentile 0.002768 mg/kg/day

(MOE of 3612) and 0.001945 (MOE of

5141); and 99.9th percentile 0.012752

mg/kg/day (MOE of 784) and 0.006688

(MOE of 1495). The 95th percentile of

exposure for females (13+/nursing) was

estimated to be 0.000602 mg/kg/day

(MOE of 16602); 99th percentile

0.002340 mg/kg/day (MOE of 4273); and

99.9th percentile 0.011387 mg/kg/day

(MOE of 878). Therefore, FMC

concludes that the acute dietary risk of

zeta-cypermethrin, as estimated by the

dietary risk assessment, does not appear

to be of concern.

b. Chronic exposure and risk. The RfD

of 0.0125 mg/kg/day for zetacypermethrin is based on a NOAEL of

1.0 mg/kg/day from a cypermethrin dog

chronic study and an uncertainty factor

of 200 (used to account for the

differences in the percentage of the

biologically active isomer). The

endpoint effect of concern was based on

gastrointestinal disturbances. A chronic

dietary exposure/risk assessment has

been performed for zeta-cypermethrin

using the above RfD. 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 are

estimated to be 0.000151 mg/kg body

weight (bwt)/day and utilize 3.0% of the

RfD for the overall U. S. population. The

ARC for nursing infants (<1 year) and

non-nursing infants (<1 year) (subgroup

most highly exposed) are estimated to

be 0.000024 mg/kg bwt/day and

0.000335 mg/kg bwt/day and utilizes

0.5% and 6.7% of the RfD, respectively.

The ARC for children 1-6 years old and

children 7-12 years old are estimated to

be 0.000285 mg/kg bwt/day and

0.000168 mg/kg bwt/day and utilizes 5.7

percent and 3.4 percent of the RfD,

respectively. The ARC for females (13+/

nursing) are estimated to be 0.000144

mg/kg bwt/day and utilizes 2.9 percent

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

percent of the RfD. Therefore, FMC

concludes that the chronic dietary risk

of zeta-cypermethrin, as estimated by

the dietary risk assessment, does not

appear to be of concern.

ii. Drinking water. Laboratory and

field data have demonstrated that

cypermethrin is immobile in soil and

will not leach into groundwater. Other

data show that cypermethrin is virtually

insoluble in water and etremely

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

groundwater 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

maimum concentration predicted in the

simulated pond was 0.052 parts per

billion. 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

epected to occur in drinking water.

2. Non-dietary exposure. Zetacypermethrin is registered for

agricultural crop applications only,

therefore non-dietary exposure

assessments are not warranted.

D. Cumulative Effects

In consideration of potential

cumulative effects of cypermethrin 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 cypermethrin

would be cumulative with those of other

chemical compounds; thus only the

potential risks of cypermethrin have

been considered in this assessment of its

aggregate exposure. FMC intends to

submit information for the EPA to

consider concerning potential

cumulative effects of cypermethrin

consistent with the schedule established

by EPA on August 4, 1997 (62 FR 42020)

(FRL–5734–6) and other EPA

publications pursuant to the Food

Quality Protection Act.

67002 Federal Register / Vol. 65, No. 217 / Wednesday, November 8, 2000 / Notices

E. Safety Determination

1. U.S. population. Based on a

complete and reliable toxicology

database, the RfD for zeta-cypermethrin

is 0.005 mg/kg/day, based on a NOAEL

of 1.0 mg/kg/day from the cypermethrin

dog chronic study and an uncertainty

factor of 200. Available information on

anticipated residues, monitoring data

and percent crop treated was

incorporated into an analysis to estimate

the Anticipated Residue Contribution

(ARC) for 26 population subgroups. The

ARC is generally considered a more

realistic estimate than an estimate based

on tolerance level residues. The ARC are

estimated to be 0.000151 mg/kg body

weight (bwt)/day and utilize 3.0 percent

of the RfD for the overall U. S.

population. The ARC for nursing infants

(<1 year) and non-nursing infants (<1

year) (subgroup most highly exposed)

are estimated to be 0.000024 mg/kg bwt/

day and 0.000335 mg/kg bwt/day and

utilizes 0.5 percent and 6.7 percent of

the RfD, respectively. The ARC for

children 1-6 years old and children 7-

12 years old are estimated to be

0.000285 mg/kg bwt/day and 0.000168

mg/kg bwt/day and utilizes 5.7 percent

and 3.4 percent of the RfD, respectively.

The ARC for females (13+/nursing) are

estimated to be 0.000144 mg/kg bwt/day

and utilizes 2.9 percent 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 percent of the

RfD. Therefore, FMC concludes that the

chronic dietary risk of zetacypermethrin, as estimated by the

aggregate risk assessment, does not

appear to be of concern. For the

purposes of assessing acute dietary risk

for zeta-cypermethrin, FMC has used

the NOAEL of 10.0 mg/kg/day from the

zeta-cypermethrin acute neurotoxicity

study in rats. The LEL of 50.0 mg/kg/

day was based on clinical signs. This

acute dietary endpoint is 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 margins of exposure

(MOE) are significantly greater than the

EPA standard of 100 for all

subpopulations. The 95th percentile of

exposure for the overall U. S.

population was estimated to be

0.000630 mg/kg/day (MOE of 15884);

99th percentile 0.002184 mg/kg/day

(MOE of 4577); and 99.9th. percentile

0.010260 mg/kg/day (MOE of 974). The

95th percentile of exposure for all

infants < 1 year old was estimated to be

0.000599 mg/kg/day (MOE of 16682);

99th percentile 0.005656 mg/kg/day

(MOE of 1768); and 99.9th percentile

0.029094 mg/kg/day (MOE of 343). The

95th percentile of exposure for nursing

infants < 1 year old was estimated to be

0.000172 mg/kg/day (MOE of 58054);

99th percentile 0.000967 mg/kg/day

(MOE of 10336); and 99.9th percentile

0.004937 mg/kg/day (MOE of 2025). The

95th percentile of exposure for nonnursing infants < 1 year old (the most

highly exposed population subgroup)

was estimated to be 0.000760 mg/kg/day

(MOE of 13155); 99th percentile

0.011082 mg/kg/day (MOE of 902); and

99.9th percentile 0.032957 mg/kg/day

(MOE of 303). The 95th percentile of

exposure for children 1 to 6 years old

and children 7 to 12 years old was

estimated to be, respectively, 0.000936

mg/kg/day (MOE of 10681) and

0.000644 mg/kg/day (MOE of 15524);

99th percentile 0.002768 mg/kg/day

(MOE of 3612) and 0.001945 (MOE of

5141); and 99.9th percentile 0.012752

mg/kg/day (MOE of 784) and 0.006688

(MOE of 1495). The 95th percentile of

exposure for females (13+/nursing) was

estimated to be 0.000602 mg/kg/day

(MOE of 16602); 99th percentile

0.002340 mg/kg/day (MOE of 4273); and

99.9th percentile 0.011387 mg/kg/day

(MOE of 878). Therefore, FMC

concludes that there is reasonable

certainty that no harm will result from

acute exposure to zeta-cypermethrin.

2. Infants and children— i. General.

In assessing the potential for additional

sensitivity of infants and children to

residues of zeta-cypermethrin, FMC

considered data from developmental

toxicity studies in the rat and rabbit,

and a 2–generation reproductive study

in the rat. The data demonstrated no

indication of increased sensitivity of

rats to zeta-cypermethrin or rabbits to

cypermethrin in utero and/or postnatal

exposure to zeta-cypermethrin or

cypermethrin. 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

pre- and post-natal toxicity and the

completeness of the database.

ii. Developmental toxicity studies. In

the prenatal developmental toxicity

studies in rats and rabbits, there was no

evidence of developmental toxicity at

the highest doses tested (35.0 mg/kg/day

in rats and 700 mg/kg/day in rabbits).

Decreased body weight gain was

observed at the maternal LOAEL in each

study; the maternal NOAEL was

established at 12.5 mg/kg/day in rats

and 100 mg/kg/day in rabbits.

iii. Reproductive toxicity study. In the

2-generation reproduction study in rats,

offspring toxicity (body weight) and

parental toxicity (body weight, organ

weight, and clinical signs) was observed

at 27.0 mg/kg/day and greater. The

parental systemic NOAEL was 7.0 mg/

kg/day and the parental systemic

LOAEL was 27.0 mg/kg/day. There were

no developmental (pup) or reproductive

effects up to 45.0 mg/kg/day, highest

dose tested.

iv. Prenatal and postnatal

sensitivity— a. Prenatal. There was no

evidence of developmental toxicity in

the studies at the highest doses tested in

the rat (35.0 mg/kg/day) or in the rabbit

(700 mg/kg/day). Therefore, there is no

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

needed to protect the safety of infants

and children. As stated above, aggregate

exposure assessments utilized

significantly less than 1% 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

cypermethrin residues.

F. International Tolerances

There are no Codex, Canadian or

Mexican residue limits for residues of

zeta-cypermethrin in or on wheat (grain,

forage, hay, straw, and bran), sorghum

(grain, forage and fodder), tomatoes,

peppers, peas and beans (dried,

succulent and edible podded), and

soybeans.

Federal Register / Vol. 65, No. 217 / Wednesday, November 8, 2000 / Notices 67003

2. FMC Corporation

PP 1F3994

EPA has received a pesticide petition

PP 1F3994 from FMC Corporation, 1735

Market Street, Philadelphia, PA 19103

proposing, pursuant to section 408(d) of

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

40 CFR 180.418 by establishing

tolerances for residues of the insecticide

zeta-cypermethrin (±-a-Cyano(3-

phenoxyphenyl)methyl (±) cis, trans 3-

(2,2-dichloroethenyl)-2,2-

dimethylcyclopropanecarboxylate) in or

on the raw agricultural commodities

(RAC): Sunflower, seeds at 0.20 ppm;

sunflower, oil at 0.20 ppm, poultry,

meat at 0.05 ppm, poultry, meat byproducts at 0.05 ppm, poultry, fat at

0.05 ppm and eggs at 0.05 ppm, meat of

cattle, goats, hogs, horses, and sheep at

0.3 ppm, fat of cattle, goats, hogs,

horses, and sheep at 2.0 ppm, and milk,

fat at 1.0 ppm (reflecting 0.2 ppm in

whole milk).

A. Residue Chemistry

1. Plant metabolism. The metabolism

of cypermethrin in plants is adequately

understood. Studies have been

conducted to delineate the metabolism

of radiolabelled cypermethrin in various

crops all showing similar results. The

residue of concern is the parent

compound only.

2. Analytical method. There is a

practical analytical method for detecting

and measuring levels of cypermethrin 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.

3. Magnitude of residues. Crop field

trial residue data from studies

conducted at the maimum label rates for

sunflowers show that the proposed zetacypermethrin tolerances on sunflower,

seeds at 0.20 ppm, sunflower, oil at 0.20

ppm.

B. Toxicological Profile

1. Acute toxicity. For the purposes of

assessing acute dietary risk, FMC has

used the NOAEL of 0.5 mg/kg/day based

on the NOAEL of 1.0 mg/kg/day from

the cypermethrin chronic toxicity study

in dogs and a correction factor of two to

account for the differences in the

percentage of the biologically active

isomer. The LOAEL of 5.0 mg/kg/day

was based on gastrointestinal

disturbances observed in the first week

of the study. This acute dietary

endpoint is used to determine acute

dietary risks to all population

subgroups.

2. Genotoxicty. The following

genotoxicity tests were all negative: In

vivo chromosomal aberration in rat bone

marrow cells; in vitro cytogenic

chromosome aberration; unscheduled

DNA synthesis; CHO/HGPRT mutagen

assay; weakly mutagenic: Gene mutation

(Ames).

3. Reproductive and developmental

toxicity. No evidence of additional

sensitivity to young rats was observed

following prenatal or postnatal exposure

to zeta-cypermethrin.

i. A 2–generation reproductive

toxicity study with zeta-cypermethrin in

rats demonstrated a NOAEL of 7.0 mg/

kg/day and a LOAEL of 27.0 mg/kg/day

for parental/systemic toxicity based on

body weight, organ weight, and clinical

signs. There were no adverse effects in

reproductive performance. The NAOEL

for reproductive toxicity was considered

to be > 45.0 mg/kg/day (the highest dose

tested (HDT)).

ii. A developmental study with zetacypermethrin in rats demonstrated a

maternal NOAEL of 12.5 mg/kg/day and

a LOAEL of 25 mg/kg/day based on

decreased maternal body weight gain,

food consumption and clinical signs.

There were no signs of developmental

toxicity at 35.0 mg/kg/day, the highest

dose level tested.

iii. A developmental study with

cypermethrin in rabbits demonstrated a

maternal NOAEL of 100 mg/kg/day and

a LOAEL of 450 mg/kg/day based on

decreased bwt gain. There were no signs

of developmental toxicity at 700 mg/kg/

day, the HDT.

4. Subchronic toxicity. Short- and

intermediate-term toxicity. The NOAEL

of 2.5 mg/kg/day from the cypermethrin

chronic toxicity study in dogs and a

correction factor of two to account for

the differences in the percentage of the

biologically active isomer would also be

used for short- and intermediate-term

MOE calculations. The LOAEL of 7.5

mg/kg/day was based on neurotoxic

clinical signs which were displayed

starting week one of the study.

5. Chronic toxicity— i. The reference

dose (RfD) of 0.005 mg/kg/day for zetacypermethrin is based on

gastrointestinal disturbances in a

cypermethrin study in dogs with an

uncertainty factor of 200 (used to

account for the differences in the

percentage of the biologically active

isomer).

ii. Cypermethrin is classified as a

Group C chemical (possible human

carcinogen with limited evidence of

carcinogenicity in animals) based upon

limited evidence for carcinogenicity in

female mice; assignment of a Q* has not

been recommended.

6. Animal metabolism. The

metabolism of cypermethrin in animals

is adequately understood. Cypermethrin

has been shown to be rapidly absorbed,

distributed, and excreted in rats when

administered orally. Cypermethrin is

metabolized by hydrolysis and oidation.

7. Metabolite toxicology. The Agency

has previously determined that the

metabolites of cypermethrin are not of

toxicological concern and need not be

included in the tolerance epression.

8. Endocrine disruption. No special

studies investigating potential

estrogenic or other endocrine effects of

cypermethrin have been conducted.

However, no evidence of such effects

were 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 cypermethrin

has an adverse effect on the endocrine

system.

C. Aggregate exposure

1. Dietary exposure— i. Food.

Permanent tolerances, in support of

registrations, currently eist for residues

of zeta-cypermethrin on cottonseed;

pecans; lettuce, head; onions, bulb; and

cabbage and livestock commodities of

cattle, goats, hogs, horses, and sheep

(along with the associated meat and

milk tolerances). For the purposes of

assessing the potential dietary exposure

for these eisting and the subject

proposed 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 one day or

single exposure. For the purposes of

assessing acute dietary risk for zetacypermethrin, FMC has used the

NOAEL of 0.5 mg/kg/day based on the

NOAEL of 1.0 mg/kg/day from the

cypermethrin chronic toxicity study in

dogs and a correction factor of two to

account for the differences in the

percentage of the biologically active

isomer. The LOAEL of 5.0 mg/kg/day

was based on gastrointestinal

disturbances which were displayed

during week one of this study. This

acute dietary endpoint is 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 margins of exposure

(MOE) are significantly greater than the

EPA standard of 100 for all

67004 Federal Register / Vol. 65, No. 217 / Wednesday, November 8, 2000 / Notices

subpopulations. The 95th percentile of

exposure for the overall U. S.

population was estimated to be

0.000330 mg/kg/day (MOE of 1514);

99th percentile 0.001136 mg/kg/day

(MOE of 440); and 99.9th percentile

0.002544 mg/kg/day (MOE of 196). The

95th percentile of exposure for all

infants < 1 year old was estimated to be

0.000096 mg/kg/day (MOE of 5211);

99th percentile 0.000365 mg/kg/day

(MOE of 1368); and 99.9th percentile

0.001438 mg/kg/day (MOE of 347). The

95th percentile of exposure for nursing

infants < 1 year old was estimated to be

0.000040 mg/kg/day (MOE of 12532);

99th percentile 0.000194 mg/kg/day

(MOE of 2575); and 99.9th percentile

0.000899 mg/kg/day (MOE of 556). The

95th percentile of exposure for nonnursing infants < 1 year old was

estimated to be 0.000114 mg/kg/day

(MOE of 4391); 99th percentile 0.000437

mg/kg/day (MOE of 1144); and 99.9th

percentile 0.001732 mg/kg/day (MOE of

288). The 95th percentile of exposure

for children 1 to 6 years old (the most

highly exposed population subgroup)

and children 7 to 12 years old was

estimated to be, respectively, 0.000442

mg/kg/day (MOE of 1131) and 0.000413

mg/kg/day (MOE of 1209); 99th

percentile 0.001355 mg/kg/day (MOE of

368) and 0.001349 (MOE of 370); and

99.9th percentile 0.003454 mg/kg/day

(MOE of 144) and 0.002928 (MOE of

170). The 95th percentile of exposure

for females (13+/nursing) was estimated

to be 0.000306 mg/kg/day (MOE of

1635); 99th percentile 0.001174 mg/kg/

day (MOE of 425); and 99.9th percentile

0.002583 mg/kg/day (MOE of 193).

Therefore, FMC concludes that the acute

dietary risk of zeta-cypermethrin, as

estimated by the dietary risk

assessment, does not appear to be of

concern.

b. Chronic exposure and risk. The RfD

of 0.005 mg/kg/day for zetacypermethrin is based on

gastrointestinal disturbances in a

cypermethrin study in dogs with an

uncertainty factor of 200 (used to

account for the differences in the

percentage of the biologically active

isomer). A chronic dietary exposure/risk

assessment has been performed for zetacypermethrin using the above RfD.

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 are

estimated to be 0.000033 mg/kg body

weight (bwt)/day and utilize 0.7 percent

of the RfD for the overall U. S.

population. The ARC for nursing infants

(<1 year) and non-nursing infants (<1

year) are estimated to be 0.000009 mg/

kg bwt/day and 0.000035 mg/kg bwt/

day and utilizes 0.2 percent and 0.7

percent of the RfD, respectively. The

ARC for children 1-6 years old

(subgroup most highly exposed) and

children 7-12 years old are estimated to

be 0.000078 mg/kg bwt/day and

0.000052 mg/kg bwt/day and utilizes 1.6

percent and 1.0 percent of the RfD,

respectively. The ARC for females (13+/

nursing) are estimated to be 0.000033

mg/kg bwt/day and utilizes 0.7 percent

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

percent of the RfD. Therefore, FMC

concludes that the chronic dietary risk

of zeta-cypermethrin, as estimated by

the dietary risk assessment, does not

appear to be of concern.

ii. Drinking water. Laboratory and

field data have demonstrated that

cypermethrin is immobile in soil and

will not leach into groundwater. Other

data show that cypermethrin is virtually

insoluble in water and etremely

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

groundwater 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

maimum 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 epected to

occur in drinking water.

2. Non-dietary exposure. Zetacypermethrin is registered for

agricultural crop applications only,

therefore non-dietary exposure

assessments are not warranted.

D. Cumulative Effects

In consideration of potential

cumulative effects of cypermethrin 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 cypermethrin

would be cumulative with those of other

chemical compounds; thus only the

potential risks of cypermethrin have

been considered in this assessment of its

aggregate exposure. FMC intends to

submit information for the EPA to

consider concerning potential

cumulative effects of cypermethrin

consistent with the schedule established

by EPA on August 4, 1997 (62 FR 42020)

(FRL–5734–6) and other EPA

publications pursuant to the Food

Quality Protection Act.

E. Safety Determination

1. U.S. population. Based on a

complete and reliable toxicology

database, the RfD for zeta-cypermethrin

is 0.005 mg/kg/day for zetacypermethrin based on gastrointestinal

disturbances in a cypermethrin study in

dogs with an uncertainty factor of 200

(used to account for the differences in

the percentage of the biologically active

isomer). Available information on

anticipated residues, monitoring data

and percent crop treated was

incorporated into an analysis to estimate

the Anticipated Residue Contribution

(ARC) for 26 population subgroups. The

ARC is generally considered a more

realistic estimate than an estimate based

on tolerance level residues. The ARC are

estimated to be 0.000033 mg/kg body

weight (bwt)/day and utilize 0.7 percent

of the RfD for the overall U. S.

population. The ARC for nursing infants

(<1 year) and non-nursing infants (<1

year) are estimated to be 0.000009 mg/

kg bwt/day and 0.000035 mg/kg bwt/

day and utilizes 0.2 percent and 0.7

percent of the RfD, respectively. The

ARC for children 1-6 years old

(subgroup most highly exposed) and

children 7-12 years old are estimated to

be 0.000078 mg/kg bwt/day and

0.000052 mg/kg bwt/day and utilizes 1.6

percent and 1.0 percent of the RfD,

respectively. The ARC for females (13+/

nursing) are estimated to be 0.000033

mg/kg bwt/day and utilizes 0.7 percent

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

percent of the RfD. Therefore, FMC

Federal Register / Vol. 65, No. 217 / Wednesday, November 8, 2000 / Notices 67005

concludes that the chronic dietary risk

of zeta-cypermethrin, as estimated by

the aggregate risk assessment, does not

appear to be of concern.

The 95th percentile of exposure for

the overall U. S. population was

estimated to be 0.000330 mg/kg/day

(MOE of 1514); 99th percentile 0.001136

mg/kg/day (MOE of 440); and 99.9th

percentile 0.002544 mg/kg/day (MOE of

196). The 95th percentile of exposure

for all infants < 1 year old was estimated

to be 0.000096 mg/kg/day (MOE of

5211); 99th percentile 0.000365 mg/kg/

day (MOE of 1368); and 99.9th

percentile 0.001438 mg/kg/day (MOE of

347). The 95th percentile of exposure

for nursing infants < 1 year old was

estimated to be 0.000040 mg/kg/day

(MOE of 12532); 99th percentile

0.000194 mg/kg/day (MOE of 2575); and

99.9th percentile 0.000899 mg/kg/day

(MOE of 556). The 95th percentile of

exposure for non-nursing infants < 1

year old was estimated to be 0.000114

mg/kg/day (MOE of 4391); 99th

percentile 0.000437 mg/kg/day (MOE of

1144); and 99.9th percentile 0.001732

mg/kg/day (MOE of 288). The 95th

percentile of exposure for children 1 to

6 years old (the most highly exposed

population subgroup) and children 7 to

12 years old was estimated to be,

respectively, 0.000442 mg/kg/day (MOE

of 1131) and 0.000413 mg/kg/day (MOE

of 1209); 99th percentile 0.001355 mg/

kg/day (MOE of 368) and 0.001349

(MOE of 370); and 99.9th percentile

0.003454 mg/kg/day (MOE of 144) and

0.002928 (MOE of 170). The 95th

percentile of exposure for females (13+/

nursing) was estimated to be 0.000306

mg/kg/day (MOE of 1635); 99th

percentile 0.001174 mg/kg/day (MOE of

425); and 99.9th percentile 0.002583

mg/kg/day (MOE of 193). Therefore,

FMC concludes that there is reasonable

certainty that no harm will result from

acute exposure to zeta-cypermethrin.

2. Infants and children— i. General.

In assessing the potential for additional

sensitivity of infants and children to

residues of zeta-cypermethrin, FMC

considered data from developmental

toxicity studies in the rat and rabbit,

and a 2–generation reproductive study

in the rat. The data demonstrated no

indication of increased sensitivity of

rats to zeta-cypermethrin or rabbits to

cypermethrin in utero and/or postnatal

exposure to zeta-cypermethrin or

cypermethrin. 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

pre- and post-natal toxicity and the

completeness of the database.

ii. Developmental toxicity studies. In

the prenatal developmental toxicity

studies in rats and rabbits, there was no

evidence of developmental toxicity at

the highest doses tested (35.0 mg/kg/day

in rats and 700 mg/kg/day in rabbits).

Decreased body weight gain was

observed at the maternal LOAEL in each

study; the maternal NOAEL was

established at 12.5 mg/kg/day in rats

and 100 mg/kg/day in rabbits.

iii. Reproductive toxicity study. In the

2–generation reproduction study in rats,

offspring toxicity (body weight) and

parental toxicity (body weight, organ

weight, and clinical signs) was observed

at 27.0 mg/kg/day and greater. The

parental systemic NOAEL was 7.0 mg/

kg/day and the parental systemic

LOAEL was 27.0 mg/kg/day. There were

no developmental (pup) or reproductive

effects up to 45.0 mg/kg/day, HDT.

iv. Pre- and post-natal sensitivity— a.

Pre-natal. There was no evidence of

developmental toxicity in the studies at

the highest doses tested in the rat (35.0

mg/kg/day) or in the rabbit (700 mg/kg/

day). Therefore, there is no evidence of

a special dietary risk (either acute or

chronic) for infants and children which

would require an additional safety

factor.

b. Post-natal. Based on the absence of

pup toxicity up to dose levels which

produced toxicity in the parental

animals, there is no evidence of special

post-natal 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

needed to protect the safety of infants

and children. As stated above, aggregate

exposure assessments utilized

significantly less than 1 percent 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 cypermethrin residues.

F. International Tolerances

There are no Codex, Canadian, or

Mexican residue limits for residues of

zeta-cypermethrin in or on sunflowers.

[FR Doc. 00–28421 Filed 11–07–00; 8:45 am]

BILLING CODE 6560–50–S

FEDERAL COMMUNICATIONS

COMMISSION

Notice of Public Information

Collection(s) Being Reviewed by the

Federal Communications Commission,

Comments Requested

November 1, 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 January 8, 2001.

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

Commissions, 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: