Federal Register / Vol. 60, No. 70 / Wednesday, April 12, 1995 / Rules and Regulations 18543

Amendments to the Regulations

For the reasons set forth above, Part

10, Customs Regulations (19 CFR part

10) is amended as set forth below:

PART 10—ARTICLES CONDITIONALLY

FREE, SUBJECT TO A REDUCED

RATE, ETC.

1. The general authority citation for

Part 10 is revised to read as follows:

Authority: 19 U.S.C. 66, 1202 (General

Note 20, Harmonized Tariff Schedule of the

United States (HTSUS)), 1321, 1481, 1484,

1498, 1508, 1623, 1624;

* * * * *

§ 10.175 [Amended]

2. In § 10.175, paragraph (e)(2) is

amended by adding ‘‘The Bahamas’’ to

the list of countries in appropriate

alphabetical order.

Approved: March 8, 1995.

John P. Simpson,

Deputy Assistant Secretary of the Treasury.

Michael H. Lane,

Acting Commissioner of Customs.

[FR Doc. 95–8917 Filed 4–11–95; 8:45 am]

BILLING CODE 4820–02–P

DEPARTMENT OF DEFENSE

Corps of Engineers

33 CFR Part 334

Danger Zones, Atlantic Ocean South of

the Entrance to the Chesapeake Bay,

Virginia Beach, Virginia

AGENCY: U.S. Army Corps of Engineers,

DoD.

ACTION: Final rule.

SUMMARY: The Corps of Engineers is

amending the regulations which

establish a danger zone in the waters of

the Atlantic Ocean south of the entrance

of the Chesapeake Bay due to the

relocation of the Southeast Sea lanes of

the Atlantic Federal Project Channel.

The relocation of the danger zone is

necessary to provide an additional

measure of safety for vessels operating

in the area. As a result of this

amendment, the danger zone will be

shifted to the south. The overall size

and configuration of the danger zone

will remain the same.

EFFECTIVE DATE: May 12, 1995.

FOR FURTHER INFORMATION CONTACT:

Mr. Rick Henderson at (804) 441–7653

or Mr. Ralph Eppard at (202) 272–1783.

SUPPLEMENTARY INFORMATION: Pursuant

to its authorities in Section 7 of the

Rivers and Harbors Act of 1917 (40 Stat.

266; 33 U.S.C. 1) and Chapter XIX of the

Army Appropriations Act of 1919 (40

Stat. 892; 33 U.S.C. 3), the Corps is

amending the danger zone regulations

in 33 CFR 334.390.

The Commanding Officer, Fleet

Combat Training Center, Atlantic, U.S.

Navy, has requested that the danger

zone be amended to reflect changes in

the routing of the Southeast Sea Lanes.

There are no changes which will affect

the public’s use of the area. As presently

configured, the danger zone is in the

path of vessel entering and departing

the Southeast Sea Lanes south of the

entrance to the Chesapeake Bay. This

amendment shifts the entire danger

zone to the south. On January 20, 1995,

we published these amendments in the

Notice of Proposed Rules section of the

Federal Register (60 FR 4134–4135)

with the comment period expiring on 19

February 1995. We received on

comments in response to the proposed

rule and accordingly, we are publishing

the final rule as proposed.

Economic Assessment and Certification

This rule is issued with respect to a

military function of the Defense

Department and the provisions of E.O.

12866 do not apply. The relocation of

the danger zone will have only minimal

impact on recreational, commercial or

fishing vessels within the area because

the vessels are not prohibited from use

of the area except when firing is in

progress at the range. The configuration

of the danger zone is not affected by this

amendment. There will be no impacts

on small businesses or governments in

the area. I hereby certify that this

regulation will have no significant

economic impact on a substantial

number of small entities.

List of Subjects in 33 CFR Part 334

Navigation (water), transportation,

restricted areas.

In consideration of the above, the

Corps is amending Part 334 of Title 33

to read as follows:

PART 334—DANGER ZONE AND

RESTRICTED AREA REGULATIONS

1. The authority citation for part 334

continues to read as follows:

Authority: 40 Stat. 266; (33 U.S.C. 1) and

40 Stat. 892; (33 U.S.C. 3).

2. In § 334.390, paragraph (a) is

revised to read as follows:

§ 334.390 Atlantic Ocean south of entrance

to Chesapeake Bay; firing range.

(a) The danger zone. A section

extending seaward for a distance of

12,000 yards between two radial lines

bearing 030° True and 083° True,

respectively, from a point on shore at

latitude 36°46′48′′N, longitude

75°57′24′′W; and an adjacent sector

extending seaward for a distance of 15

nautical miles between two radial lines

bearing 083° True and 150° True,

respectively, from the same shore

position.

* * * * *

Dated: March 24, 1995.

Stanley G. Genega,

Major General, U.S. Army, Director of Civil

Works.

[FR Doc. 95–8958 Filed 4–11–95; 8:45 am]

BILLING CODE 3710–92–M

ENVIRONMENTAL PROTECTION

AGENCY

40 CFR Part 180

[PP 9F3855, 2F4121, 4F4413/R2121; FRL–

4947–2]

RIN 2070–AB78

Sethoxydim; Pesticide Tolerances

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Final rule.

SUMMARY: This document establishes a

pesticide tolerance for the combined

residues of the herbicide sethoxydim (2-

[1-(ethoxyimino)butyl]-5-[2-

(ethylthio)propyl]-3-hydroxy-2-

cyclohexen-1-one) and its metabolites

containing the 2-cyclohexen-1-one

moiety (calculated as the herbicide)) in

or on the raw agricultural commodities

(RACs) clover forage at 35 parts per

million (ppm), clover hay at 50 ppm,

almond hulls at 2.0 ppm and the crop

groupings tree nuts at 0.2 ppm and

cucurbit vegetables at 4.0 ppm. The

BASF Corp. requested these regulations

to establish maximum permissible

levels for residues of the pesticide in or

on the above commodities and crop

groupings.

EFFECTIVE DATE: April 12, 1995.

ADDRESSES: Written objections and

hearing requests, identified by the

document control number, [PP 9F3855,

2F4121, 4F4413/R2121], may be

submitted to: Hearing Clerk (1900),

Environmental Protection Agency, Rm

M3708, 401 M St., SW., Washington, DC

20460. A copy of any objections and

hearing requests filed with the Hearing

Clerk should be identified by the

document control number and

submitted 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
18544 Federal Register / Vol. 60, No. 70 / Wednesday, April 12, 1995 / Rules and Regulations

copy of objections and hearing request

to: Rm. 1132, CM #2, 1921 Jefferson

Davis Hwy., Arlington, VA 22202. Fees

accompanying objections shall be

labeled ‘‘Tolerance Petition Fees’’ and

forwarded to: EPA Headquarters

Accounting Operations Branch, OPP

(Tolerance Fees), P.O. Box 360277M,

Pittsburgh, PA 15251.

FOR FURTHER INFORMATION CONTACT: By

mail, Robert J. Taylor, Product Manager

(PM 25), Registration Division (7505C),

Office of Pesticide Programs,

Environmental Protection Agency, 401

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

Office location and telephone number:

Rm. 241, CM #2, 1921 Jefferson Davis

Hwy., Arlington, VA 22202, (703)-305-

6027; e-mail:

taylor.robert@epamail.epa.gov.

SUPPLEMENTARY INFORMATION: EPA has

issued notices in the Federal Register

announcing that BASF Corp., P.O. Box

13528, Research Triangle Park, NC

27709-3528, had submitted pesticide

petitions to EPA proposing to amend 40

CFR part 180 pursuant to section 408(d)

of the Federal Food, Drug, and Cosmetic

Act (FFDCA), 21 U.S.C. 346a(d),

establishing regulations to permit the

combined residues of the herbicide

sethoxydim (2-[1-(ethoxyimino)butyl]-5-

[2-(ethylthio)propyl]-3-hydroxy-2-

cyclohexen-1-one) and its metabolites

containing the 2-cyclohexen-1-one

moiety (calculated as the herbicide) in

or on certain RACs.

1. PP 9F3855. Published in the

Federal Register of June 29, 1990 (54 FR

26751), the notice proposed establishing

a regulation to permit residues of the

herbicide on tree nuts at 0.2 ppm and

almond hulls at 2.0 ppm.

2. PP 2F4121. Published in the

Federal Register of December 30, 1992

(57 FR 62334), the notice proposed

establishing a regulation to permit

residues of the herbicide on clover.

3. PP 4F4413. Published in the

Federal Register of February 8, 1995 (60

FR 7541), the notice proposed

establishing a regulation to permit

residues of the herbicide on the crop

grouping cucurbit vegetables at 4.0 ppm.

No comments were received in

response to the notices of filing.

The filing notice for PP 2F4121

should have proposed establishing a

regulation to permit residues of the

herbicide in or on clover forage at 35

ppm and clover hay at 50 ppm. Because

clover forage and hay are animal feeds,

not human foods, and current tolerances

in livestock commodities will not be

exceeded as a result of the proposed

tolerances on clover forage and hay,

there is no potential increase risk to

humans. Therefore, an additional period

of public comment is not necessary.

The scientific data submitted in the

petitions and other relevant material

have been evaluated. The toxicological

data considered in support of the

proposed tolerances include:

1. Several acute toxicology studies

that place technical sethoxydim in acute

toxicity category IV for primary eye and

dermal irritation and acute toxicity

category III for acute oral, dermal, and

inhalation. The dermal sensitizationguinea pig study was waived because no

sensitization was seen in guinea pigs

dosed with the end-use product Poast

(18% a.i.).

2. A 21-day dermal study with rabbits

fed dosages of 0, 40, 200, and 1,000 mg/

kg/day with a NOAEL (no-observedadverse-effect level) of greater than

1,000 mg/kg/day (limit dose).

3. A 1-year feeding study with dogs

fed dosages (based on consumption) of

0, 8.86/9.41, 17.5/19.9, and 110/129 mg/

kg/day (males/females) with a NOEL

(no-observed-effect level) of 8.86/9.41

mg/kg/day (males/ females) based on

equivocal anemia in males and females

at 17.5/19.9 mg/kg/day, respectively.

4. A 2-year chronic feeding/

carcinogenicity study with mice fed

dosages of 0, 6, 18, 54, and 162 mg/kg/

day with no carcinogenic effects

observed under the conditions of the

study at dose levels up to and including

162 mg/kg/day (highest dose tested

[HDT]) and a systemic NOEL of 18 mg/

kg/day. A maximum tolerated dose

(MTD) was not achieved for females in

this study. A determination of the need

for an additional study will be made

once the replacement chronic feeding/

carcinogenicity study in rats is

evaluated.

5. A 2-year chronic feeding/

carcinogenic study with rats fed dosages

of 0, 2, 6, and 18 mg/kg/day (HDT) with

no carcinogenic effects observed under

the conditions of the study at dosage

levels up to and including 18 mg/kg/day

(HDT) and a systemic NOEL greater than

or equal to 18 mg/kg/day (HDT). This

study was reviewed under current

guidelines and was found to be

unacceptable because the doses used

were insufficient to induce a toxic

response and a maximum tolerated dose

(MTD) was not achieved. This study

must be repeated.

6. A chronic feeding/carcinogenic

study with rats was submitted to

supplement the above study. Rats in this

study were fed dosages of 0, 18.2/23.0,

and 55.9/71.8 mg/kg/day (males/

females) with no carcinogenic effects

observed under the conditions of the

study at dose levels up to and including

55.9/71.8 mg/kg/day (HDT) (males/

females) and a systemic NOEL greater

than or equal to 55.9/71.8 mg/kg/day

(males/females). The doses used were

insufficient to induce a toxic response

and failed to achieve an MTD or define

a Lowest Effect Level (LEL). Slight

decreases in body weights in the final

quarter of the study, although not

biologically significant, can support a

free-standing NOAEL of 55.9/71.8 mg/

kg/day (males/females). A new study is

necessary to replace both this study and

the one discussed above.

7. A developmental toxicity study in

rats fed dosages of 0, 50, 180, 650, and

1,000 mg/kg/day with a maternal

NOAEL of 180 mg/kg/day and a

maternal LEL of 650 mg/kg/day

(irregular gait, decreased activity,

excessive salivation, and anogenital

staining); and a developmental NOAEL

of 180 mg/kg/day and a developmental

LEL of 650 mg/kg/day (21 to 22%

decrease in fetal weights, filamentous

tail and lack of tail due to the absence

of sacral and/or caudal vertebrae, and

delayed ossification in the hyoids,

vertebral centrum and/or transverse

processes, sternebrae and/or

metatarsals, and pubes).

8. A developmental toxicity study in

rabbits fed doses of 0, 80, 160, 320, and

400 mg/kg/day with a maternal NOEL of

320 mg/kg/day and a maternal lowestobservable-effect level (LOEL) of 400

mg/kg/day (37% reduction in body

weight gain without significant

differences in group mean body weights,

and decreased food consumption during

dosing); and a developmental NOEL

greater than 400 mg/kg/day (HDT).

9. A two-generation reproduction

study with rats fed dosage levels of 0,

150, 600, and 3,000 ppm (approximately

0, 7.5, 30, and 150 mg/kg/day) with no

reproductive effects observed at 3,000

ppm (approximately 150 mg/kg/day)

(HDT). However, the Agency considers

this study usable for regulatory

purposes and has established a freestanding NOEL of 3,000 ppm

(approximately 150 mg/kg/ day).

10. Mutagenicity studies included:

Ames Assays which were negative for

Salmonella typhimurium strains TA98,

TA100, TA1535, and TA 1537, with and

without metabolic activity; sethoxydim

did not cause structural chromosomal

aberrations at doses up to 5,000 mg/kg

in Chinese hamster bone marrow cells

in vivo; a Host-Mediated Assay (mouse)

with S. typhimurium was negative at 2.5

grams/kg/day of chemical, and

recombinant assays and forward

mutations in Bacillus subtilis,

Escherichia coli, and S. typhimurium

were all negative at concentrations of

greater than or equal to 100%; an in

vitro Unscheduled DNA Synthesis
Federal Register / Vol. 60, No. 70 / Wednesday, April 12, 1995 / Rules and Regulations 18545

Assay in Primary Rat Hepatocytes had a

negative response for DNA repair (UDS)

in primary rat hepatocyte cultures

exposed up to insoluble (greater than

101 micrograms per milliliter) and

cytotoxic (507 micrograms per milliliter)

doses.

11. In a rat metabolism study,

excretion was extremely rapid and

tissue accumulation was negligible,

assuming DMSO vehicle does not affect

excretion or storage of NP-55 (78%

excreted into urine and 20.1% into

feces).

The reference dose (RFD) based on a

NOEL of 8.86 mg/kg bwt/day in the 1-

year feeding study in dogs and an

uncertainty factor of 100 was calculated

to be 0.09 mg/kg bwt/day. The

theoretical maximum residue

contribution (TMRC) for existing

tolerances for the overall U. S.

population is 0.032341 mg/kg bwt/day

or 35.9% of the RfD. The current action

will increase the TMRC by 0.000563

mg/kg bwt/day. These tolerances and

previously established tolerances utilize

a total of 36.5 percent of the RfD for the

overall U.S. population. For U.S.

subgroup populations, nonnursing

infants and children aged 1 to 6, the

current action and previously

established tolerances utilize,

respectively, a total of 62.75 percent and

73.5 percent of the ADI, assuming that

residue levels are at the established

tolerances and that 100 percent of the

crop is treated.

Cross Reference Note: These studies

are also referenced in an EPA proposed

rule on sethoxydim appearing in the

‘‘Proposed Rules’’ section of this issue

of the Federal Register.

Desirable data lacking based on

review of data under current guidelines

include a repeat of the chronic feeding/

carcinogenicity study in rats. Once the

rat study is evaluated, a repeat of the

mouse carcinogenicity study may be

needed. Because the current studies,

although unacceptable by current

guidelines, provide useful information

and these tolerances utilize less than 1

percent of the RfD, the Agency believes

there is little risk from establishing

these tolerances. Any additional

tolerance proposals will be considered

on a case-by-case basis.

The pesticide is useful for the

purposes for which these tolerances are

sought and capable of achieving the

intended physical or technical effect.

The nature of the residue is adequately

understood, and adequate analytical

methods, gas chromatography using

sulfur-specific flame photometric

detection, are available for enforcement

purposes. The method for tree nuts and

cucurbits is listed in the Pesticide

Analytical Manual, Vol. II (PAM II), as

Method I. The analytical methods for

clover forage and hay are revisions of

the above method. Because of the long

lead time from establishing these

tolerances until publication, the

enforcement methodology for clover

forage and hay is being made available

in the interim to anyone interested in

pesticide enforcement when requested

by mail from: Calvin Furlow, Public

Response and Program Resources

Branch, Field Operations Division

(7506C), Office of Pesticide Programs,

Environmenal Protection Agency, 401 M

St., SW., Washington, DC 20460. Office

location and telephone number; Rm.

1130A, CM #2, 1921 Jefferson Davis

Hwy., Arlington VA 22202.

There are currently no actions

pending against the registration of this

chemical. Any expectation of residues

occurring in eggs, milk, meat, fat, or

meat byproducts of cattle, goats, hogs,

horses, and sheep or poultry will be

covered by existing tolerances.

Based on the information and data

considered, the Agency has determined

that the tolerances established by

amending 40 CFR part 180 would

protect the public health. Therefore,

EPA is establishing the tolerances as set

forth below.

Any person adversely affected by this

regulation may, within 30 days after

publication of this document in the

Federal Register, file written objections

with the Hearing Clerk, at the address

given above. 40 CFR 178.20. A copy of

the objections and/or hearing requests

filed with the Hearing Clerk should be

submitted to the OPP docket for this

rulemaking. The objections submitted

must specify the provisions of the

regulation deemed objectionable and the

grounds for the objections. 40 CFR

178.25. Each objection must be

accompanied by the fee prescribed by

40 CFR 180.33(i). If a hearing is

requested, the objections must include a

statement of the factual issue(s) on

which a hearing is requested, the

requestor‘s contentions on each such

issue, and a summary of any evidence

relied upon by the objector. 40 CFR

178.27. A request for a hearing will be

granted if the Administrater determines

that the material submitted shows the

following: There is a genuine and

substantial issue of fact; there is a

reasonable possibility that available

evidence identified by the requestor

would, if established, resolve one or

more of such issues in favor of the

requestor, taking into account

uncontested claims or facts to the

contrary; and resolution of the factual

issue(s) in the maner sought by the

requestor would be adequate to justify

the action requested. 40 CFR 178.32.

Under Executive Order 12866 (58 FR

51735, October 4, 1993), the Agency

must determine whether the regulatory

action is ‘‘significant’’ and therefore

subject to review by the Office Of

Management and Budget (OMB) and the

requirements of the Executive Order.

Under section 3(f), the order defines a

‘‘significant regulatory action’’ as an

action that is likely to result in a rule

(1) having an annual effect on the

economy of $100 million or more, or

adversely and materially affecting a

sector of the economy, productivity,

competition, jobs, the environment,

public health or safety, or State, local,

or tribal governments or communities

(also referred to as ‘‘economically

significant’’); (2) creating serious

inconsistency or otherwise interfering

with an action taken or planned by

another agency; (3) materially altering

the budgetary impacts of entitlement,

grants, user fees, or loan programs or the

rights and obligation of recipients

thereof; or (4) raising novel legal or

policy issues arising out of legal

mandates, the President‘s priorities, or

the principles set forth in this Executive

Order.

Pursuant to the terms of the Executive

Order, EPA has determined that this

rule is not ‘‘significant’’ and is therefore

not subject to OMB review. Pursuant to

the requirements of the Regulatory

Flexibility Act (Pub. L. 96-354, 94 Stat.

1164, 5 U.S.C. 601-612), the

Administrator has determined that

regulations establishing new tolerances

or raising tolerance levels or

establishing exemptions from tolerance

requirements do not have a significant

economic impact on a substantial

number of small entities. A certification

statement to this effect was published in

the Federal Register of May 4, 1981 (46

FR 24950).

List of Subjects in 40 CFR Part 180

Environmental protection,

Administrative practice and procedure,

Agricultural commodities, Pesticides

and pests, Reporting and recordkeeping

requirements.

Dated: March 30, 1995.

Stephen L. Johnson,

Director, Registration Division, Office of

Pesticide Programs.

Therefore, 40 CFR part 180 is

amended as follows:

PART 180—[AMENDED]

1. The authority citation for part 180

continues to read as follows:

Authority: 21 U.S.C. 346a and 371.
18546 Federal Register / Vol. 60, No. 70 / Wednesday, April 12, 1995 / Rules and Regulations

2. In § 180.412, by revising the section

heading and introductory texts of

paragraphs (a) and (b) and by amending

paragraph (a) in the table therein by

adding and alphabetically inserting new

entries for almond hulls; clover, forage;

clover, hay; and tree nuts and by

revising the entry for cucurbits

vegetables, to read as follows:

§ 180.412 2-[1-(Ethoxyimino)butyl]-5-[2-

(ethylthio)propyl]-3-hydroxy-2-cyclohexen1-one; tolerances for residues.

(a) Tolerances are established for the

combined residues of the herbicide 2-[1-

(ethoxyimino)butyl]-5-(2-

(ethylthio)propyl]-3-hydroxy-2-

cyclohexen-1-one and its metabolites

containing the 2-cyclohexen-1-one

moiety (calculated as the herbicide) in

or on the following commodities:

Commodity Parts per

million

* * * * *

Almond hulls ............................. 2.0

* * * *

Clover, forage ........................... 35.0

Clover, hay ............................... 50.0

* * * * *

Cucurbits vegetables ................ 4.0

* * * * *

Tree nuts .................................. 0.2

* * * * *

(b) Tolerances with regional

registration, as defined in § 180.1(n), are

established for the combined residues of

the herbicide 2-[1-(ethoxyimino)butyl]-

5-(2-(ethylthio)propyl]-3-hydroxy-2-

cyclohexen-1-one and its metabolites

containing the 2-cyclohexen-1-one

moiety (calculated as the herbicide) in

or on the following commodities:

* * * *

*

[FR Doc. 95–8731 Filed 4–11–95; 8:45 am]

BILLING CODE 6560–50–F

40 CFR Part 180

[PP 4F4318/R2118; FRL–4945–2]

RIN 2070–AB78

Beauveria Bassiana Strain GHA;

Tolerance Exemption

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Final rule.

SUMMARY: This rule establishes an

exemption from the requirement for a

tolerance for residues of Beauveria

bassiana Strain GHA in or on all raw

agricultural commodities. Mycotech

Corp. requested this exemption.

EFFECTIVE DATE: This regulation

becomes effective April 12, 1995.

ADDRESSES: Written objections,

identified by the document control

number, [PP4F4318/R2118], may be

submitted to: Hearing Clerk (1900),

Environmental Protection Agency, Rm.

M3708, 401 M St., SW., Washington, DC

20460. A copy of any objections and

hearing requests filed with the Hearing

Clerk should be identified by the

document control number and

submitted 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

a copy of objections and hearing request

to Rm. 1132, CM #2, 1921 Jefferson

Davis Hwy., Arlington, VA 22202. Fees

accompanying objections shall be

labeled ‘‘Tolerance Petition Fees’’ and

forwarded to : EPA Headquarters

Accounting Operations Branch, OPP

(Tolerance Fees), P.O. Box 360277M,

Pittsburgh, PA 15251.

FOR FURTHER INFORMATION CONTACT: By

mail: Patricia A. Cimino, Biopesticides

and Pollution Prevention Division

(7501W), Office of Pesticide Programs,

Environmental Protection Agency, 401

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

(703)-308-7035; e-mail:

Cimino.Patricia@epamail.epa.gov.

SUPPLEMENTARY INFORMATION: In the

Federal Register of July 13, 1994 (59 FR

35718), EPA issued a notice that

Mycotech Corp., 630 Utah Drive, P.O.

Box 4109, Butte, MT 59701, had

submitted pesticide petition PP 4F4318

proposing to amend 40 CFR part 180 by

establishing a regulation pursuant to

section 408 of the Federal Food, Drug,

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

346a(d), to exempt from the requirement

of a tolerance the residues of the

microbial pest control agent Beauveria

bassiana Strain GHA in or on alfalfa,

corn, potatoes, rapeseed, safflower,

small grain crops, soybeans, sugarbeets,

sunflower, rangeland, improved

pastures, and in meat, milk or other

animal products from livestock grazed

on treated rangeland or improved

pastures when applied to growing crops

in accordance with good agricultural

practices.

There were no comments received in

response to the notice of filing.

In the Federal Register of February 8,

1995 (60 FR 7543), EPA issued a notice

that Mycotech Corp., 630 Utah Drive,

P.O. Box 4109, Butte, MT 59701, had

submitted an amendment to a pesticide

petition, PP 4F4318, proposing to

amend 40 CFR part 180 by establishing

a regulation pursuant to section 408 of

the Federal Food, Drug, and Cosmetic

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

exempt from the requirement of a

tolerance the residues of the microbial

pest control agent Beauveria bassiana

Strain GHA in or on all raw agricultural

commodities.

Beauveria bassiana Strain GHA is

naturally occurring and was originally

isolated from indigenous grasshoppers.

The data submitted in the petition

and all other relevant material have

been evaluated. The toxicological data

considered in support of the exemption

from the requirement of a tolerance for

Beauveria bassiana Strain GHA in or on

all raw agricultural crops include an

acute oral toxicity/pathogenicity study,

an acute dermal toxicity study, an acute

pulmonary toxicity/pathogenicity study,

an acute intraperitoneal toxicity/

pathogenicity study, and primary eye

irritation studies.

The results of these studies indicated

that the organism was not toxic to test

animals when administered via oral,

dermal, pulmonary, or intraperitoneal

routes.

The active ingredient was not

infective or pathogenic to the test

animals in any of the studies. Ocular

lesions were observed in the eye

irritation studies with the technicalgrade active ingredient (TGAI) and a

wettable powder (WP) formulation and

resulted in a Toxicity Category I rating

for these products. Minimal ocular

irritation was observed in the eye

irritation studies done with oil flowable

and emulsifiable suspension end-use

product formulations indicating that the

lesions observed in the eye irritation

tests done with TGAI and the WP

formulations may have been due to

physical effects of the TGAI and inert

ingredients. Slight skin irritation

persisted in test animals treated with

the TGAI resulting in a Toxicity

Category III rating. There have been no

reports of hypersensitivity related to the

active ingredient. All of the toxicity

studies submitted are considered

acceptable.

The toxicology data provided are

sufficient to demonstrate that there are

no foreseeable human health hazards

likely to arise from use of Beauveria

bassiana Strain GHA on the requested

food and feed commodities when

applied during the growing season in

accordance with good agricultural

practices.

Acceptable daily intake (ADI) and

maximum permissible intake (MPI)

considerations are not relevant to this

petition because the data submitted

demonstrated that this biological control

agent is not toxic to humans by dietary

exposure. No enforcement actions are