Federal Register / Vol. 63, No. 130 /Wednesday, July 8, 1998 / Notices 36903

A developmental toxicity study in rats

was conducted on ATONIK.

Administration was by gavage at dose

levels of 0, 100, 300, and 600 mg/kg/

day. Significantly decreased body

weight gain and food consumption was

observed at 600 mg/kg/day in the female

rats. One death was noted and attributed

to the test chemical. The maternal no

observed effect level (NOEL) and LOEL

were determined to be 300 and 600 mg/

kg/day, respectively. No developmental

toxicity was observed. The NOEL for

developmental toxicity was determined

to be 600 mg/kg/day.

The Ames Test, Mouse Micronucleus

Assay and the Mouse Lymphoma Assay

were each performed with each of the

three active ingredients in ATONIK.

All results were negative.

The toxicity studies are sufficient to

demonstrate that there are no

foreseeable human or domestic animal

health hazards possible from use of

these active ingredients as plant

regulators in the concentrations present

in ATONIK.

D. Aggregate Exposure

The end-use product, ATONIK,

contains the three active ingredients in

very low concentrations. At the

application rates employed, the level of

active ingredient which may be present

in any of the food or feed items would

be far below the levels which

demonstrated any effects in the

subchronic oral feeding study, the

developmental toxicity study or the

mutagenicity studies. It can be shown

that in order to reach a dose rate

comparable to the LOEL of 1,600 mg/kg/

day obtained in the subchronic oral

feeding study, a person weighing 50 kg

would have to consume all of the

produce from 4 acres of crop every day.

Further, due to the rapid uptake and

metabolism of the three active

ingredients in the plants, it is most

unlikely that any of the residue would

be available for potential exposure.

Similarly, exposure of the residues to

humans from consumption of water

would be equally unlikely. There is no

allowed use of the product containing

the three active ingredients on lawns,

rights-of-way, golf courses, or other

areas where human exposure may

result. Therefore, exposure from these

areas would be non-existent.

E. Cumulative Exposure

Exposure through other pesticides

and substances with the same mode of

toxicity is not likely. What little toxicity

that is observed is only observed at

extremely high concentrations of these

active ingredients.

F. Safety Determination

The three active ingredients in the

end-use product, ATONIK, are all

biochemicals. The low toxicity of each

of these alone and in combination, as

discussed above, demonstates that these

chemicals, at the rates established, will

not pose any known risk to human

health, either as children or as adults.

These three active ingredients are

already exempted from the requirements

of a tolerance for use on cotton, rice and

soybeans.

G. Effects on the Immune and Endocrine

Systems

The Agency has no information to

suggest that ATONIK will have an

effect on the immune and endorine

systems. The Agency is not requiring

information on the endocrine effects of

this biological pesticide at this time.

Congress has allowed 3 years after

August 3, 1996, for the Agency to

implement a screening program with

respect to endocrine effects.

H. Existing Tolerances

Exemptions from the requirements of

a tolerance have already been

established for residues of the

biochemical plant regulators Sodium oNitrophenolate, Sodium pNitrophenolate, and Sodium 5-

Nitroguaiacolate in or on the raw

agricultural commodities cottonseed,

cotton gin by products, rice, rice straw,

soybeans, and soybean forage and hay.

I. International Tolerances

No known international tolerances

have been granted for this pesticide.

Therefore, based on the completeness

and reliability of the toxicity data from

the published literature and

conservative exposure assessment,

Asahi Manufacturing Company, Ltd.,

concludes that there is a reasonable

certainty that no harm will result from

aggregate exposure to residues of the

ATONIK including all anticipated

dietary exposure and all nonoccupational exposures.

[FR Doc. 98–18076 Filed 7–7–98; 8:45 am]

BILLING CODE 6560–50–F

ENVIRONMENTAL PROTECTION

AGENCY

[OPP–50842; FRL–5798–4]

Issuance of an Experimental Use

Permit

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Notice.

SUMMARY: EPA has granted an

experimental use permit to the

following applicant. The permit is in

accordance with, and subject to, the

provisions of 40 CFR part l72, which

defines EPA procedures with respect to

the use of pesticides for experimental

use purposes.

FOR FURTHER INFORMATION CONTACT: By

mail: Sheila Moats, Biopesticides and

Pollution Prevention Division (7511C),

Office of Pesticide Programs,

Environmental Protection Agency, 401

M St., SW., Washington, DC 20460.

Office location, telephone number, and

e-mail address: 9th Floor, CM #2, 1921

Jefferson Davis Highway, Arlington, VA,

(703) 308–1259, e-mail:

moats.sheila@epamail.epa.gov.

SUPPLEMENTARY INFORMATION: EPA has

issued the following experimental use

permit:

70515–EUP–1. Issuance. J P

BioRegulators, Inc., IR-4 Project Rutgers

University, Cook College, P.O. Box 231,

New Brunswick, NJ 08903–0231. This

experimental use permit allows the use

of 72 kilograms each year for the

biochemical phospholipid: Lyso-PE

(lysophosphatidylethanolamine) on 520

acres of apples, citrus, cranberries,

grapes, peaches, pears, nectarines,

strawberries, and tomatoes to evalaute

pre-harvest and post-harvest ripening

and storage shelf-life. The program is

authorized only in the States of Arizona,

California, Florida, Massachusetts,

Michigan, Ohio, Washington, West

Virginia, and Wisconsin. The program is

effective from June 3, 1998 to June 1,

2001.

Persons wishing to review this

experimental use permit are referred to

the designated contact person. Inquires

concerning this permit should be

directed to the person 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: June 24, 1998.

Janet L. Andersen,

Director, Biopesticides and Pollution

Prevention Division, Office of Pesticide

Programs.

[FR Doc. 98–18077 Filed 7–7–98; 8:45 am]

BILLING CODE 6560–50–F