7454 Federal Register / Vol. 62, No. 33 / Wednesday, February 19, 1997 / Notices

set in the proposed tolerances. EPA will

provide information on this method to

the Food and Drug Administration

(FDA). The method is available to

anyone who is interested in pesticide

residue enforcement from EPA’s Field

Operations Division, Office of Pesticide

Programs.

2. Nine-barley trials were conducted

in eight states. Fifty-four one-time

treated grain, hay, and straw samples

(fed commodities) were analyzed. In

addition, eighteen one-time treated

forage samples were analyzed. Residues

of difenoconazole in barley grown from

seed treated with difenoconazole were

below the LOQ in forage, hay, and straw

(<0.05 ppm), and grain (<0.01 ppm).

The feeding of difenoconazole-treated

barley products to beef or dairy cattle

will not require an increase in existing

beef tissue or milk tolerances. Similarly,

the feeding of difenoconazole-treated

barley grain to poultry will not require

increasing existing established poultry

tissue and egg tolerances.

J. Environmental Fate

Since the Agency classifies seed

treatment uses as ‘‘indoor,’’ the only

environmental fate data requirement is

hydrolysis. Difenoconazole is

hydrolytically stable in solution at 25 °C

at pH 5, 7, or 9.

II. Public Record

EPA invites interested persons to

submit comments on this notice of

filing. Comments must bear a

notification indicating the docket

control number [PF–703].

A record has been established for this

notice under docket control number

[PF–703] including comments and data

submitted electronically as described

below). A public version of this record,

including printed, paper versions of

electronic comments, which does not

include any information claimed as CBI,

is available for inspection from 8:30

a.m. to 4 p.m., Monday through Friday,

excluding legal holidays. The public

record is located in Room 1132 of the

Public Response and Program Resources

Branch, Field Operations Division

(7506C), Office of Pesticide Programs,

Environmental Protection Agency,

Crystal Mall #2, 1921 Jefferson Davis

Highway, Arlington, VA.

Electronic comments can be sent

directly to EPA at:

opp-Docket@epamail.epa.gov

Electronic comments must be

submitted as an ASCII file avoiding the

use of special characters and any form

of encryption.

The official record for this notice, as

well as the public version, as described

above will be kept in paper form.

Accordingly, EPA will transfer all

comments received electronically into

printed, paper form as they are received

and will place the paper copies in the

official record which will also include

all comments submitted directly in

writing.

The official record is the paper record

maintained at the address in

‘‘ADDRESSES’’ at the beginning of this

notice.

List of Subjects

Environmental protection,

Administrative practice and procedure,

Agricultural commodities, Pesticides

and pests, Reporting and recordkeeping

requirements.

Dated: February 4, 1997.

Stephen L. Johnson,

Director, Registration Division, Office of

Pesticide Programs.

[FR Doc. 97–3930 Filed 2–18–97; 8:45 am]

BILLING CODE 6560–50–F

[PF–699; FRL–5585–5]

Zeneca Ag Products; Pesticide

Tolerance Petition Filing

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Notice of filing.

SUMMARY: This notice announces the

filing of a pesticide petition proposing

the establishment of a regulation for

residues of lambda-cyhalothrin and its

epimer in or on rice. The names for

lambda-cyhalothrin and its epimer are

as follows: lambda-cyhalothrin, a 1:1

mixture of (S)-alpha-cyano-3-

phenoxybenzyl-(Z)-(1R,3R)-3-(2-chloro3,3,3-trifluoroprop-1-enyl)-2,2-

dimethylcyclopropanecarboxylate and

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

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

dimethylcyclopropanecarboxylate.

Epimer of lambda-cyhalothrin, a 1:1

mixture of (S)-alpha-cyano-3-

phenoxybenzyl-(Z)(1S,3S)-3-(2-chloro3,3,3-trifluoroprop-1-enyl)-2,2-

dimethylcyclopropanecarboxylate and

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

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

dimethylcyclopropanecarboxylate. The

summary was prepared by the

petitioner, Zeneca Ag Products.

DATES: Comments, identified by the

docket control number [PF–699], must

be received on or before March 21, 1997.

ADDRESSES: By mail, submit written

comments to: Public Response and

Program Resources Branch, Field

Operations Division (7506C), Office of

Pesticide Programs, Environmental

Protection Agency, 401 M St., SW.,

Washington, DC 20460. In person, bring

comments to: Crystal Mall #2, Room

1132, 1921 Jefferson Davis Highway,

Arlington VA.

Comments and data may also be

submitted electronically by sending

electronic mail (e-mail) to: oppdocket@epamail.epa.gov. Electronic

comments must be submitted as an

ASCII file avoiding the use of special

characters and any form of encryption.

Comments and data will also be

accepted on disks in WordPerfect in 5.1

file format or ASCII file format. All

comments and data in electronic form

must be identified by the docket control

number [PF–699]. Electronic comments

on this notice may be filed online at

many Federal Depository Libraries.

Additional information on electronic

submissions can be found in Unit II. of

this document.

Information submitted as a comment

concerning this notice may be claimed

confidential by marking any part or all

of that information as ‘‘Confidential

Business Information’’ (CBI). CBI should

not be submitted through e-mail.

Information marked as CBI will not be

disclosed except in accordance with

procedures set forth in 40 CFR part 2.

A copy of the comment that does not

contain CBI must be submitted for

inclusion in the public record.

Information not marked confidential

may be disclosed publicly by EPA

without prior notice. All written

comments will be available for public

inspection in Room 1132 at the address

given above, from 8:30 a.m. to 4 p.m.,

Monday through Friday, excluding legal

holidays.

FOR FURTHER INFORMATION CONTACT: By

mail, George LaRocca, Product Manager,

(PM 13), Registration Division, Office of

Pesticide Programs, Environmental

Protection Agency, 401 M St., SW.,

Washington, DC 20460. Office location,

telephone number, and e-mail address:

Crystal Mall #2, 1921 Jefferson Davis

Highway, Arlington, VA, 703-305-6100,

e-mail: larocca.george@epamail.epa.gov.

SUPPLEMENTARY INFORMATION: EPA has

received a pesticide petition (PP–

6F4769) from Zeneca Ag Products, 1800

Concord Pike, P.O. Box 15458,

Wilmington, DE 19850-5458. The

petition proposes, pursuant to section

408 of the Federal Food, Drug and

Cosmetic Act (FFDCA), 21 U.S.C.

346a(d), to amend 40 CFR part 180 to

establish tolerances for residues of the

insecticide lambda-cyhalothrin in or on

the raw agricultural commodities rice
Federal Register / Vol. 62, No. 33 / Wednesday, February 19, 1997 / Notices 7455

grain at 1.0 parts per million (ppm), rice

straw at 1.75 ppm, and in or on the

processed commodity rice hulls at 5.0

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. EPA has determined the

proposed analytical method is gas liquid

chromatography with an electron

capture detector. As required by section

408(d) of the FFDCA, as recently

amended by the Food Quality Protection

Act (FQPA) Pub. L. 104-170, Zeneca Ag

Products (Zeneca) included in the

petition a summary of the petition and

authorization for the summary to be

published in the Federal Register in a

notice of receipt of the petition. The

summary represents the views of

Zeneca; EPA as mentioned above, is in

the process of evaluating the petition.

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

FFDCA, EPA is including the summary

as a part of this notice of filing. EPA

may have made edits to the summary for

the purpose of clarity.

I. Petiton Summary

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. Sixteen field

trials were carried out on rice during

1995 in the United States. The trials

were conducted in the states of

Arkansas, Louisiana, Missouri,

Mississippi, Texas, and California.

These states account for 100% of the

production acres of rice in the United

States. The number and geographical

distribution of the trials agrees with the

recommendation given in the ‘‘EPA

Residue Chemistry Guidance’’ (1994). In

these trials, the maximum combined

residues of lambda-cyhalothrin and

epimer were 0.88 ppm in or on rice

grain and 1.62 ppm in or on rice straw.

In addition, a single field trial was

conducted during 1995 in the States of

Mississippi and Arkansas for the

purpose of determining if lambdacyhalothrin residues in rice, concentrate

in or on processed rice fractions. Data

from these trials demonstrated that

residues of lambda-cyhalothrin may

concentrate up to 6.1 times in or on rice

hulls but do not concentrate in rice bran

or polished rice.

B. Toxicological Profile

The following toxicity studies have

been conducted to support the request

for a regulation for residues of lambdacyhalothrin in or on rice.

1. Acute toxicity. Acute toxicity

studies with the technical grade of the

active ingredient lambda-cyahothrin:

oral LD50 in the rat of 79 milligram/

kilogram (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. Genotoxicity. 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. i. A three-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 no observed effect level

(NOEL) and lowest observed effect level

(LOEL) 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 NOEL and LOEL 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.

ii. 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 NOEL

is greater than 15 mg/kg/day, the highest

dose tested. The maternal NOEL and

LOEL are established at 10 and 15 mg/

kg/day, respectively, based on reduced

body weight gain.

iii. 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 NOEL and LOEL are

established at 10 and 30 mg/kg/day,

respectively, based on decreased body

weight gain. The developmental NOEL

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

dose tested.

4. Subchronic toxicity. i. A 90-day

feeding study in rats fed doses of 0, 10,

50, and 250 ppm with a NOEL of 50

ppm and a LOEL of 250 ppm based on

body weight gain reduction.

ii. A 21-day study in rabbits exposed

dermally to doses of 0, 10, 100, and

1,000 mg/kg/day, 6 hours/day, 5 days/

week with a systemic NOEL >1,000 mg/

kg/kg. There were no clinical signs of

systemic toxicity at any dose level

tested.

5. Chronic toxicity. i. A 12-month

feeding study in dogs fed dose (by

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

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

The LOEL for this study is established

at 0.5 mg/kg/day based upon clinical

signs of neurotoxicity.

ii. A 24-month chronic feeding/

carcinogenicity study with rats fed diets

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

NOEL was established at 50 ppm and

LOEL at 250 ppm based on reduced

body weight gain. There were no

carcinogenic effects observed under the

conditions of the study.

iii. 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 NOEL was

established at 100 ppm and systemic

LOEL 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).

Zeneca concludes 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

in multiple oral dose studies are similar

to single-dose studies. There is an

accumulation of unchanged compound

in fat upon chronic administration with

slow elimination. Otherwise, lambdacyhalothrin was rapidly metabolized

and excreted. The metabolism of

lambda-cyhalothrin in livestock has

been studied in the goat, chicken, and

cow. Unchanged lambda-cyhalothrin is

the major residue component of

toxicological concern in meat and milk.

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,

Zeneca concludes that there is no need

to discuss metabolite toxicity.
7456 Federal Register / Vol. 62, No. 33 / Wednesday, February 19, 1997 / Notices

C. Aggregate Exposure

1. Dietary exposure— i. Food. For the

purposes of assessing the potential

dietary exposure for all existing and

pending tolerances for lambdacyhalothrin, Zeneca has utilized

available information on anticipated

residues and percent crop treated. For

all existing and pending tolerances the

anticipated residue contribution (ARC)

is estimated at 0.0002682 mg/kg/body

weight (bwt)/day.

ii. Drinking water. Laboratory and

field data have demonstrated that

lambda-cyhalothrin and its degradates

are immobile in soil and will not leach

into groundwater. Other data show that

lambda-cyhalothrin is virtually

insoluble in water and extremely

lipophilic. As a result, Zeneca

concludes that residues reaching surface

waters from field runoff will quickly

adsorb to sediment particles and be

partitioned from the water column.

Zeneca concludes that together these

data indicate that residues are not

expected in drinking water.

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. Zeneca has no data upon

which to estimate exposure from these

uses. However, given the extremely low

vapor pressure of lambda-cyhalothrin

(1.5 x 10-9 millimeters (mm) of mercury

(Hg)) and the low use rates, it is

anticipated that inhalation and dermal

exposure from these uses Zeneca

concludes will be insignificant.

D. Cumulative Effects

At this time, Zeneca cannot make a

determination based on available and

reliable information that lambdacyhalothrin and other substances that

may have a common mechanism of

toxicity would have cumulative effects.

Thus, Zeneca concludes that for

purposes of this tolerance it is

appropriate only to consider the

potential risks of lambda-cyhalothrin in

an aggregate exposure assessment.

E. Safety Determination

The acceptable reference dose (RfD)

based on a NOEL of 0.1 mg/kg/bwt/day

from the chronic dog study and a safety

factor of 100 is 0.001 mg/kg/bwt/day. A

chronic dietary exposure/risk

assessment has been performed for

lambda-cyhalothrin using the above

RfD. Available information on

anticipated residues and percent crop

treated was incorporated into the

analysis to estimate the ARC. The ARC

is generally considered a more realistic

estimate than an estimate based on

tolerance level residues.

1. U.S. population. The ARC from

established tolerances and the current

and pending actions are estimated to be

0.0002682 mg/kg/bwt/day and utilize

26.82% of the RfD for the U.S.

population.

2. Infants and children. The ARC for

children, aged 1 to 6 years old, and nonnursing infants (subgroups most highly

exposed) utilizes 57% and 65% of the

RfD, respectively. Generally speaking,

the Agency has no cause for concern if

ARC for all published and proposed

tolerances is less than the RfD.

F. International Tolerances

There are no Codex maximum residue

levels (MRL) established for residues of

lambda-cyhalothrin in or on rice.

II. Public Record

EPA invites interested persons to

submit comments on this notice of

filing. Comments must bear a

notification indicating the docket

control number [PF–699].

A record has been established for this

notice under docket control number

[PF–699] (including comments and data

submitted electronically as described

below). A public version of this record,

including printed, paper versions of

electronic comments, which does not

include any information claimed as CBI,

is available for inspection from 8:30

a.m. to 4 p.m., Monday through Friday,

excluding legal holidays. The public

record is located in Room 1132 of the

Public Response and Program Resources

Branch, Environmental Protection

Agency, Crystal Mall #2, 1921 Jefferson

Davis Highway, Arlington, VA.

Electronic comments can be sent

directly to EPA at:

opp-docket@epamail.epa.gov.

Electronic comments must be

submitted as an ASCII file avoiding the

use of special characters and any form

of encryption. The official record for

this notice, as well as the public

version, as described above will be kept

in paper form. Accordingly, EPA will

transfer all comments received

electronically into printed, paper form

as they are received and will place the

paper copies in the official record which

will also include all comments

submitted directly in writing.

The official record is the paper record

maintained at the address in

‘‘ADDRESSES’’ at the beginning of this

notice.

List of Subjects

Environmental protection,

Administrative practice and procedure,

Agricultural commodities, Pesticides

and pests, Reporting and recordkeeping

requirements.

Dated: February 6, 1997.

Peter Caulkins,

Acting Director, Registration Division, Office

of Pesticide Programs.

[FR Doc. 97–3932 Filed 2–18–97; 8:45 am]

BILLING CODE 6560–50–F

OFFICE OF SCIENCE AND

TECHNOLOGY POLICY

Meeting of the President’s Committee

of Advisors on Science and

Technology

ACTION: Notice of meeting.

SUMMARY: This notice sets forth the

schedule and summary agenda for a

meeting of the President’s Committee of

Advisors on Science and Technology

(PCAST), and describes the functions of

the Committee. Notice of this meeting is

required under the Federal Advisory

Committee Act.

DATES AND PLACE: March 6–7, 1997. The

White House Conference Center,

Truman Room, Third Floor, 726 Jackson

Place, N.W., Washington, D.C. 20500.

TYPE OF MEETING: Open.

PROPOSED SCHEDULE AND AGENDA: The

PCAST will meet in an open session

during the afternoon of Thursday,

March 6, 1997, at approximately 1:30

p.m. The meeting will focus on

concluding the Educational

Technologies report, the FY98 budget

briefings, and the kickoff of the 1997

PCAST Studies. This session will end at

approximately 5:30 p.m.

The Committee will reconvene in

open session on Friday, March 7, 1997,

at approximately 9:30 a.m., for a general

discussion among Committee members

and other Executive Office staff about

current activities of the Office of

Science and Technology Policy (OSTP)

and the National Science and

Technology Council (NSTC).

FOR FURTHER INFORMATION: For

information regarding time, place, and

agenda, please call Jeanie Hall at (202)

456–6100 prior to 3:00 p.m. on

Wednesday, March 5, 1997. Other

questions may be directed to Angela

Phillips Diaz, Executive Secretary for

PCAST, or Andrea Razzaghi at (202)

456–6100. Please note that public

seating for this meeting is limited, and

is available on a first-come, first-served

basis.

SUPPLEMENTARY INFORMATION: The

President’s Committee of Advisors on

Science and Technology was