25724 Federal Register / Vol. 65, No. 86 / Wednesday, May 3, 2000 / Notices

commodities due to the new dermal

application of spinosad to cattle, a Tier

II dietary risk assessment can be

calculated.

2. Drinking water. Another potential

source of dietary exposure are residues

in drinking water. Based on the

available environmental studies

conducted with spinosad which shows

little or no mobility in soil, there is no

anticipated exposure to residues of

spinosad in drinking water. In addition,

there is no established maximum

concentration level for residues of

spinosad in drinking water.

3. Non-dietary exposure. Spinosad is

being submitted in this application for

control of ectoparasites on cattle and

agricultural premises. Spinosad is

currently registered for use on a number

of crops including cotton and various

fruits and vegetables, all of which

involve applications of spinosad in an

agriculture environment. Spinosad is

also currently registered for outdoor use

on turf and ornamentals at low rates of

application (0.04 to 0.54 lb active

ingredent per acre) and indoor use for

drywood termite control extremely low

application rates with no occupant

exposure expected. Thus, the potential

for non-occupational exposure to the

general population is considered

negligible.

D. Cumulative Effects

The potential for cumulative effects of

spinosad and other substances that have

a common mechanism of toxicity is also

considered. In terms of insect control,

spinosad causes excitation of the insect

nervous system, leading to involuntary

muscle contractions, prostration with

tremors, and finally paralysis. These

effects are consistent with the activation

of nicotinic acetylcholine receptors by a

mechanism that is clearly novel and

unique among known insecticidal

compounds. Spinosad also has effects

on the gamma aminobatopic acid

(GABA) receptor function that may

contribute further to its insecticidal

activity. Based on results found in tests

with various mammalian species,

spinosad appears to have a mechanism

of toxicity like that of many amphiphilic

cationic compounds. There is no

reliable information to indicate that

toxic effects produced by spinosad

would be cumulative with those of any

other pesticide chemical. Thus it is

appropriate to consider only the

potential risks of spinosad in an

aggregate exposure assessment.

E. Safety Determination

1. U.S. population. Using the

conservative exposure assumptions and

the proposed RfD described above, the

aggregate exposure (based on food and

feed wherein potable water and nonoccupational exposure is expected to be

negligible) to spinosad use on cattle as

well as existing registered crop uses will

utilize 41.8% of the RfD for the U.S.

population. A more realistic estimate of

dietary exposure and risk relative to a

chronic toxicity endpoint is obtained if

market share percentage is applied to

the tolerance levels to yield anticipated

residue values. Inserting the anticipated

residue values as a result of the percent

market share, in place of tolerance

residue levels produces a more realistic,

but still conservative risk assessment.

Based on anticipated residues which

considers percent of market share in a

dietary risk analysis, the use of spinosad

on cattle and premises as well as

existing registered crop uses will utilize

36.9% of the RfD for the U.S.

population. EPA generally has no

concern for exposures below 100% of

the RfD because the RfD represents the

level at or below which daily aggregate

dietary exposure over a lifetime will not

pose appreciable risks to human health.

Thus, it is clear that there is reasonable

certainty that no harm will result from

aggregate exposure to spinosad residues

on all existing crop uses and the

pending animal uses.

2. Infants and children. In assessing

the potential for additional sensitivity of

infants and children to residues of

spinosad, data from developmental

toxicity studies in rats and rabbits and

a 2–generation reproduction study in

rats are considered. The developmental

toxicity studies are designed to evaluate

adverse effects on the developing

organism resulting from pesticide

exposure during prenatal development.

Reproduction studies provide

information relating to effects from

exposure to the pesticide on the

reproductive capability and potential

systemic toxicity of mating animals and

on various parameters associated with

the well-being of pups.

FFDCA section 408 provides that EPA

may apply an additional safety factor for

infants and children in the case of

threshold effects to account for prenatal

and postnatal toxicity and the

completeness of the data base. Based on

the current toxicological data

requirements, the data base for spinosad

relative to prenatal and postnatal effects

for children is complete. Further, for

spinosad, the NOAEL in the chronic

feeding study which was used to

calculate the RfD (0.027 mg/kg/day) is

already lower than the NOAELs from

the developmental studies in rats and

rabbits by a factor of more than 10–fold.

Concerning the reproduction study in

rats, the pup effects shown at the

highest dose tested were attributed to

maternal toxicity. Therefore, it is

concluded that an additional

uncertainty factor is not needed and that

the RfD at 0.027 mg/kg/day is

appropriate for assessing risk to infants

and children. In addition, EPA has

determined that the 10x factor to

account for enhanced sensitivity of

infants and children is not needed

because:

i. The data provided no indication of

increased susceptibility of rats or rabbits

to in utero and/or postnatal exposure to

spinosad. In the prenatal developmental

toxicity studies in rats and rabbits and

2–generation reproduction in rats,

effects in the offspring were observed

only at or below treatment levels which

resulted in evidence of parental toxicity.

ii. No neurotoxic signs have been

observed in any of the standard required

studies conducted.

iii. The toxicology data base is

complete and there are no data gaps.

Using the conservative exposure

assumptions previously described

(tolerance level residues), the percent

RfD utilized by the use of spinosad on

cattle and premises as well as existing

registered crop uses is 96.1% for

children 1–6 years old, the most

sensitive population subgroup. Based on

anticipated residues which considers a

percent of market share in a dietary risk

analysis, the use of spinosad on cattle

and premises as well as existing

registered crop uses will utilize 81.9%

of the RfD for the children 1–6 years

old. Thus, based on the completeness

and reliability of the toxicity data and

the conservative exposure assessment, it

is concluded that there is a reasonable

certainty that no harm will result to

infants and children from aggregate

exposure to spinosad residues on the

proposed crop uses, including all

existing crop uses.

F. International Tolerances

There are no Codex maximum residue

levels established for residues of

spinosad on any commodity.

[FR Doc. 00–10772 Filed 5–2–00; 8:45 am]

BILLING CODE 6560–50–F

ENVIRONMENTAL PROTECTION

AGENCY

[OPP–50867; FRL–6552–5]

Issuance of Experimental Use Permits

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Notice.

SUMMARY: EPA has granted experimental

use permits (EUPs) to the following

Federal Register / Vol. 65, No. 86 / Wednesday, May 3, 2000 / Notices 25725

pesticide applicants. An EUP permits

use of a pesticide for experimental or

research purposes only in accordance

with the limitations in the permit.

FOR FURTHER INFORMATION CONTACT: By

mail: Registration Division (7505C),

Office of Pesticide Programs,

Environmental Protection Agency, Ariel

Rios Bldg., 1200 Pennsylvania Ave.,

NW., Washington, DC 20460.

In person or by telephone: Contact the

designated person at the following

address at the office location, telephone

number, or e-mail address cited in each

experimental use permit: 1921 Jefferson

Davis Highway, Arlington, VA.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

This action is directed to the public

in general. Although this action may be

of particular interest to those persons

who conduct or sponsor research on

pesticides, the Agency has not

attempted to describe all the specific

entities that may be affected by this

action. If you have any questions

regarding the information in this action,

consult the designated contact person

listed for the individual EUP.

B. How Can I Get Additional

Information, Including Copies of this

Document and Other Related

Documents?

You may obtain electronic copies of

this document from the EPA Internet

Home Page at http://www.epa.gov/. 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/.

II. EUPs

EPA has issued the following EUPs:

241–EUP–147. Issuance. American

Cyanamid Company, P.O. Box 400,

Princeton, NJ 08543–0400. This

experimental use permit allows the use

of 408 pounds of the herbicide

ammonium salt of imazethapyr on 3,712

acres of rice to evaluate the control of

barnyardgrass, large crabgrass, red rice,

broadleaf signalgrass, amazon

sprangletop and bearded sprangletop.

The program is authorized only in the

States of Arkansas, Louisiana,

Mississippi, Puerto Rico, and Texas.

The experimental use permit is effective

from April 6, 2000 to March 31, 2002.

This permit is issued with the limitation

that all treated crops will be destroyed,

used for research purposes only, or are

stored in a bonded warehouse. (James A.

Tompkins; Rm. 241, Crystal Mall #2;

telephone number: (703) 305–5697; email address: tompkins.jim@epa.gov).

241–EUP–146. Issuance. American

Cyanamid Company, P.O. Box 400,

Princeton, NJ 08543–0400. This

experimental use permit allows the use

of 60 pounds of the herbicide

ammonium salt of imazamox on 1,280

acres of wheat to evaluate the control of

broadleaf and grass weeds. The program

is authorized only in the States of

Arizona, Colorado, Minnesota, Montana,

and North Dakota. The experimental use

permit is effective from April 18, 2000

to December 31, 2001. This permit is

issued with the limitation that all

treated crops will be destroyed, used for

research purposes only, or are stored in

a bonded warehouse. (James A.

Tompkins; Rm. 241, Crystal Mall #2;

telephone number: (703) 305–5697; email address: tompkins.jim@epa.gov).

45639–EUP–60. Amendment and

Extension. Aventis CropScience USA

LP, 2 T.W. Alexander Drive, Research

Triangle Park, NC 27709. This

experimental use permit allows the use

of 1,825 pounds of the herbicide

glufosinate-ammonium on 2,500 acres of

rice to evaluate the control of weeds.

The program is authorized only in the

States of Arkansas, Louisiana, and

Texas. The experimental use permit is

effective from March 17, 2000 to

November 30, 2000. This permit was

issued with the conditions that: (1) The

rice seed will be secured in separate

storage facilities and the quantity of

seed, name and place, and person(s) in

charge of the storage facilities are

reported annually under section

172.8(b) until the stored rice seed is

released for sale or other uses; (2) the

rice seed derived from the use-pattern

described on the labeling of the

pesticide product used in this EUP will

not be sold prior to registration of the

use-pattern for rice; and (3) the rice

straw is destroyed by incorporating it

into soil, or by composting, followed by

incorporating its compost into soil.

(Eugene Wilson; Rm. 237, Crystal Mall

#2; telephone number: (703) 305–6103;

e-mail address:

wilson.eugene@epa.gov).

Persons wishing to review these EUPs

are referred to the designated contact

person. Inquiries concerning these

permits should be directed to the

persons cited above. It is suggested that

interested persons call before visiting

the EPA office, so that the appropriate

file may be made available for

inspection purposes from 8 a.m. to 4

p.m., Monday through Friday, excluding

legal holidays.

Authority: 7 U.S.C. 136.

List of Subjects

Environmental protection,

Experimental use permits.

Dated: April 25, 2000.

James Jones,

Director, Registration Division, Office of

Pesticide Programs.

[FR Doc. 00–11032 Filed 5–2–00; 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.

DATE AND PLACE: May 18, 2000,

Washington, DC. This meeting will take

place in the Truman Room (Third Floor)

of the White House Conference Center,

726 Jackson Place, NW, Washington,

DC.

Type of Meeting:

Open.

Proposed Schedule And Agenda

The President’s Committee of

Advisors on Science and Technology

(PCAST) is scheduled to meet in open

session on Thursday, May 18, 2000, at

approximately 1:00 p.m., to discuss (1)

public-private research partnerships;

and (2) the work of the PCAST panels.

This session will end at approximately

5:00 p.m.

Public Comments

There will be a time allocated for the

public to speak on any of the above

agenda items. Please make your request

for the opportunity to make a public

comment five (5) days in advance of the

meeting. Written comments are

welcome any time prior to or following

the meeting. Please notify Cynthia

Chase, of the PCAST Executive

Secretariat, at (202) 456–6100, or fax

your requests/comments to (202) 456–

6026.

FOR FURTHER INFORMATION CONTACT: For

information regarding time, place, and

agenda, please call Cynthia Chase, of the

PCAST Executive Secretariat, at (202)

456–6100, prior to 3:00 p.m. on

Wednesday, May 17, 2000. Information