Federal Register / Vol. 65, No. 121 / Thursday, June 22, 2000 / Rules and Regulations 38753

Commodity

Parts

per

million

Expiration/

Revocation

Date

Almond, hulls ................ 5.0 None

Apple ............................ 1.5 None

Bean, snap, succulent .. 2.0 None

Birdfoot trefoil ............... 2.0 None

Birdfoot trefoil, hay ....... 5.0 None

Blackberry .................... 2.0 None

Blueberry ...................... 5.0 None

Boysenberry ................. 2.0 None

Broccoli ......................... 2.0 None

Brussels sprouts ........... 2.0 None

Cabbage ....................... 2.0 None

Cauliflower .................... 2.0 None

Celery ........................... 2.0 None

Cherry ........................... 2.0 None

Clover ........................... 2.0 None

Clover, hay ................... 5.0 None

Cottonseed ................... 0.5 None

Crabapple ..................... 1.5 None

Cranberry ..................... 0.5 None

Cucumber ..................... 2.0 None

Eggplant ....................... 0.3 None

Filbert ........................... 0.3 None

Fruit, citrus, group ........ 2.0 None

Grape ........................... 4.0 None

Loganberry ................... 2.0 None

Melon ............................ 2.0 None

Onion ............................ 2.0 None

Parsley, leaf ................. 5.0 None

Parsley, root ................. 2.0 None

Peach ........................... 2.0 None

Pear .............................. 1.5 None

Pecan ........................... 0.3 None

Pepper .......................... 0.3 None

Pistachio ....................... 0.3 None

Plum, prune .................. 2.0 None

Potato ........................... 0.2 None

Quince .......................... 1.5 None

Raspberry ..................... 2.0 None

Spinach ........................ 2.0 None

Strawberry .................... 2.0 None

Sugarcane .................... 0.3 6/30/00

Tomato, postharvest .... 2.0 None

Walnut .......................... 0.3 None

(b) Section 18 emergency exemptions.

[Reserved]

(c) Tolerances with regional

registrations. [Reserved]

(d) Indirect or inadvertent residues.

[Reserved]

§§ 180.154a and 180.531 [Removed]

3. By removing § 180.154a and

§ 180.531.

[FR Doc. 00–15725 Filed 6–21–00; 8:45 am]

BILLING CODE 6560–50–F

ENVIRONMENTAL PROTECTION

AGENCY

40 CFR Part 180

[OPP–300924; FRL–6383–7]

RIN 2070–AB78

Trichoderma Harzianum Rifai Strain T39; Exemption from the Requirement

of a Tolerance

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Final rule.

SUMMARY: This regulation establishes an

exemption from the requirement of a

tolerance for residues of Trichoderma

harzianum Rifai strain T-39 on all food

commodities when applied/used as

ground and certain foliar applications.

Makhteshim Agan of North America

submitted a petition to EPA under the

Federal Food, Drug, and Cosmetic Act,

as amended by the Food Quality

Protection Act of 1996 requesting an

exemption from the requirement of a

tolerance. This regulation eliminates the

need to establish a maximum

permissible level for residues of

Trichoderma harzianum Rifai strain T39.

DATES: This regulation is effective June

22, 2000. Objections and requests for

hearings, identified by docket control

number OPP–300924, must be received

by EPA on or before August 21, 2000.

ADDRESSES: Written objections and

hearing requests may be submitted by

mail, in person, or by courier. Please

follow the detailed instructions for each

method as provided in Unit VIII. of the

‘‘SUPPLEMENTARY INFORMATION’’

section. To ensure proper receipt by

EPA, your objections and hearing

requests must identify docket control

number OPP–300924 in the subject line

on the first page of your response.

FOR FURTHER INFORMATION CONTACT: By

mail: Shanaz Bacchus, Biopesticides

and Pollution Prevention Division

(7511C), Office of Pesticide Programs,

Environmental Protection Agency, Ariel

Rios Bldg., 1200 Pennsylvania Ave.,

NW., Washington, DC 20460; telephone

number: 703–308–8097; and e-mail

address: bacchus.shanaz@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 Examples of Potentially

Affected Entities

Industry 111 Crop production

112 Animal production

311 Food manufacturing

32532 Pesticide manufacturing

This listing is not intended to be

exhaustive, 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 in the ‘‘FOR FURTHER

INFORMATION CONTACT’’ section.

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’’ 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

OPP–300924. 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.

38754 Federal Register / Vol. 65, No. 121 / Thursday, June 22, 2000 / Rules and Regulations

II. Background and Statutory Findings

In the Federal Register of June 26,

1998 (63 FR 34390–34392) (FRL–5794–

9), EPA issued a notice pursuant to

section 408 of the Federal Food, Drug,

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

346a, as amended by the Food Quality

Protection Act (FQPA) (Public Law 104–

170) announcing the filing of a pesticide

tolerance petition by Makhteshim Agan

of North America, (hereafter referred to

as MANA), 551 Fifth Avenue, Suite

1100, New York, NY 10176. This notice

included a summary of the petition

prepared by the petitioner, MANA.

There were no comments received in

response to the notice of filing.

The petition requested that 40 CFR

part 180 be amended by establishing an

exemption from the requirement of a

tolerance for residues of Trichoderma

harzianum Rifai strain T-39.

III. Risk Assessment

New Section 408(c)(2)(A)(i) of the

FFDCA allows EPA to establish an

exemption from the requirement for a

tolerance (the legal limit for a pesticide

chemical residue in or on a food) only

if EPA determines that the tolerance is

‘‘safe.’’ Section 408(c)(2)(A)(ii) defines

‘‘safe’’ to mean that ‘‘there is a

reasonable certainty that no harm will

result from aggregate exposure to the

pesticide chemical residue, including

all anticipated dietary exposures and all

other exposures for which there is

reliable information.’’ This includes

exposure through drinking water and in

residential settings, but does not include

occupational exposure. Section

408(b)(2)(C) requires EPA to give special

consideration to exposure of infants and

children to the pesticide chemical

residue in establishing a tolerance and

to ‘‘ensure that there is a reasonable

certainty that no harm will result to

infants and children from aggregate

exposure to the pesticide chemical

residue...’’ Additionally, section

408(b)(2)(D) requires that the Agency

consider ‘‘available information’’

concerning the cumulative effects of a

particular pesticide’s residue and ‘‘other

substances’’ that have a common

mechanism of toxicity.

EPA performs a number of analyses to

determine the risks from aggregate

exposure to pesticide residues. First,

EPA determines the toxicity of

pesticides. Second, EPA examines

exposure to the pesticide through food,

drinking water, and through other

exposures that occur as a result of

pesticide us in residential settings.

IV. Toxicological Profile

Consistent with section 408(b)(2)(D)

of FFDCA, EPA has reviewed the

available scientific data and other

relevant information in support of this

action and considered its validity,

completeness and reliability and the

relationship of this information to

human risk. EPA has also considered

available information concerning the

variability of the sensitivities of major

identifiable subgroups of consumers,

including infants and children.

Trichoderma harzianum strain T-39

was considered neither toxic nor

pathogenic based on the results of the

Tier I toxicology studies. Tier II and Tier

III studies were not required because the

results from the Tier I studies were

sufficient to satisfy guideline

requirements. On the basis of the

studies submitted, it was considered a

Toxicity Category III pesticide for acute

oral effects due to the amount dosed

only, and Toxicity Category IV for

dermal and primary dermal irritation

health effects. These and additional

toxicology studies are summarized

below.

1. Acute oral infectivity/

pathogenicity. Based on the submitted

data, Trichoderma harzianum strain T39 demonstrated a low toxicity profile.

It was not infectious, pathogenic or

toxic to rats when administered orally at

1.4 to 2.0 × 108 colony forming units

(cfu) per animal. Clearance and

infectivity were evaluated in the brain,

blood, lymph nodes, kidney, liver,

spleen, lungs, caecum and feces. The

microbe was detected only in fecal

samples, and in those samples a distinct

clearance pattern was demonstrated

throughout the study.

2. Acute dermal toxicity. A single

1,150–1,570 mg/kg dose of Trichoderma

harzianum was applied dermally for a

24 hour exposure period to rabbits.

There were no clinical signs of toxicity

and no effects on mortality or body

weight nor any signs of dermal irritation

during the study. The available

information indicates that dermal

toxicity is not likely to occur with

Trichoderma harzianum strain T-39.

3. Primary Dermal Irritation Study. A

dermal application of 0.5g of

Trichoderma harzianum strain T-39 at 5

× 109 cfu/g produced no dermal

response in rabbits after a 4–hour

exposure period. The results of this

study are classified as Supplementary,

but taken in conjunction with the acute

dermal toxicity study, the microbial

pesticide is likely to be mildly irritating

to skin. The pesticide was classified as

Toxicity Category IV for primary dermal

irritation effects.

4. Skin sensitization in guinea pig.

Under the conditions of this study,

Trichoderma harzianum strain T-39 in

physiological saline was applied in

occluded dermal patches. This study

demonstrated potential delayed contact

hypersensitivity in guinea-pigs. This

study was designed to meet the

requirements of the OECD Guidelines

for Testing Chemicals, and was

submitted in support of fulfilling EPA

data requirements for hypersensitivity

incidents. While the study is not a

substitute for reporting hypersensitivity

incidents, it was considered acceptable.

However, the registrant must report any

hypersensitivity incidents to the

Agency. The label must indicate that

products containing this active

ingredient are likely to demonstrate a

potential for dermal sensitization.

5. Primary eye irritation. Three eye

irritation studies were submitted. Two

acute eye irritation studies were

conducted using undiluted TGAI on a

single male rabbit each time. The

studies indicated a potential for severe

eye irritation, placing the undiluted

TGAI in acute Toxicity Category I. In

one study, a single dose of 0.1g of the

active ingredient, approximately 5 × 108

cfu, was used to treat one rabbit. The

results indicated that the microbial pest

control agent (MPCA) TGAI,

Trichoderma harzianum strain T-39, has

the potential to cause serious ocular

damage. The active ingredient was a

severe eye irritant. In another study a

single dose of 0.1g was administered

into the everted lower right eyelid of a

sentinel male rabbit. The results of this

study indicated that a 3 minute, 180 ml

saline rinse, applied 3 minutes post

dosing, had no ameliorating effect on

the irritancy of the active ingredient.

The adhesion of the TGAI to the

conjunctivae remained a serious effect

of treatment even after rinsing.

However, another eye irritation study

was done in which the test material was

the End-use Product (EP), Trichodex.

Six male rabbits were treated with a

single dose of 0.1 ml (0.04 g) of

Trichodex-EP into the everted lower

right eyelid. The maximum average

irritation score was determined to be

15.3 at 24 hours post dosing. There was

no corneal involvement after 72 hours

and ocular irritation was no longer

present after 7 days, equivalent to a

mildly irritating, or an acute Toxicity

Category III rating for the EP. This study

was considered acceptable and can be

used for labeling of the EP. Workers,

who are most likely to be exposed to the

pesticide during mixing/loading,

application and post application

activities, are required to wear goggles

to mitigate against potential eye

irritation.

6. Acute intraperitoneal toxicity/

pathogenicity. Under conditions of this

study the LD50 for the EP, Trichodex,

Federal Register / Vol. 65, No. 121 / Thursday, June 22, 2000 / Rules and Regulations 38755

administered via intraperitoneal

injection was 644 mg/Kg in male rats,

1.087 mg/Kg in female rats and 806 mg/

Kg for combined results from male and

female rats. The lowest dose

administered, 1.5 × 107 cfu/animal,

showed no indications of significant

adverse effects. This study was

considered acceptable and is a

substitute for the intravenous study

with fungi as active pesticidal

ingredients.

7. Acute pulmonary toxicity/

pathogenicity. Small 2 mm pale raised

areas were found in the lungs of some

animals of both genders treated with test

material containing the active fungi.

However, minimal clinical signs and no

deaths were observed. There were no

significant macroscopic lesions found in

any test animals in the other

experimental groups. The active

ingredient was not found in samples of

liver, brain, spleen, kidneys, lymph

nodes or blood. Microbial clearance

through the caecum was evident.

Although there was no evidence of the

reproduction of the microbe in the

tissues, colony forming units persisted

in the lungs of animals treated with the

active fungus. However, no adverse

effects were seen even in the absence of

lung clearance by day 21. Based on this

study the TGAI was classified as

Toxicity Category III. Because the

predominant inert ingredient is known

to have associated irritation and

inhalation effects, the microbial, EP was

classified as an acute Toxicity Category

II pesticide or likely to be a moderate

acute inhalation hazard. Workers who

are most likely to be exposed during

mixing/loading, application and post

application activities are required to

wear the recommended respirators with

NIOSH prefixes, N–95, P–95 or R–95, to

mitigate against exposure.

8. Mouse Micronucleus Test. This

study is not required under the

guidelines for registration of microbials

but was submitted by the registrant for

consideration of the application. A

preliminary toxicity test using doses of

2,500 and 5,000 mg/Kg resulted in no

deaths and no significant chromosome

damage. Subsequently, the main study

was carried out with administration of

Trichodex suspended in 0.5% methyl

cellulose solution by oral gavage. Doses

were 200, 1,000, or 5,000 mg/kg. Under

conditions of this test, there was no

evidence of chromosomal damage

leading to micronucleus formation in

polychromatic erythrocytes of treated

mice 24, 48, or 72 hours after dosing.

The study was rated supplemental.

V. Aggregate Exposures

In examining aggregate exposure,

FFDCA section 408 directs EPA to

consider available information

concerning exposures from the pesticide

residue in food and all other nonoccupational exposures, including

drinking water from groundwater or

surface water and exposure through

pesticide use in gardens, lawns, or

buildings (residential and other indoor

uses).

A. Dietary Exposure

Dietary exposure to the microbial

pesticide is likely to occur. The lack of

acute oral toxicity/pathogenicity, and

the ubiquitous nature of the microbial,

support the establishment of an

exemption from the requirement of a

tolerance for Trichoderma harzianum

strain T-39.

1. Food. The microbial pesticide can

be removed from foods by washing,

peeling, cooking and processing. Dietary

exposure to the microbial and the risk

posed to adults, infants and children are

likely to be minimal, because of the low

acute oral toxicity/pathogenicity

potential of the microbial pesticide.

2. Drinking water exposure. Oral

exposure, at very low levels, may occur

from ingestion of drinking water.

Drinking water is not being screened for

Trichoderma harzianum as a potential

indicator of microbial contamination.

Both percolation through soil and

municipal treatment of drinking water

would reduce the possibility of

exposure to the fungal active ingredient

through drinking water. Therefore, the

potential of significant transfer of

residues to drinking water is minimal to

non-existent. Even if negligible oral

exposure should occur through drinking

water, the Agency concludes that such

exposure would present no risk due to

the lack of acute oral toxicity/

pathogenicity and the ubiquitous nature

of the microbe.

B. Other Non-Occupational Exposure

Dermal and inhalation exposure.

Dermal and inhalation exposures and

risks to adults, infants and children via

treated lawns or recreational areas are

not likely if the pesticide is applied as

labeled. However, should such

exposures occur, adverse effects via the

dermal and inhalation routes are

expected to be minimal based on the

low toxicity potential of this naturally

occurring, ubiquitous microbe.

VI. Cumulative Effects

There are other species and strains of

Trichoderma registered. The Agency has

received information to distinguish

strain T-39 from other registered strains.

It is not clear to the Agency whether the

registered strains share a common

mechanism of toxicity, or any

mechanism of toxicity with strain T-39.

Because the data available demonstrate

a low toxicity/pathogenicity potential of

the active ingredient, the likelihood of

adverse dietary effects is expected to be

minimal.

VII. Determination of Safety for U.S.

Population, Infants and Children

Based on the information in this

preamble, EPA concludes that there is a

reasonable certainty of no harm from

aggregate exposure to the U.S.

population to Trichoderma harzianum

Rifai strain T-39 residues. This includes

all anticipated dietary exposures and all

other exposures for which there is

reliable information. The Agency has

imposed appropriate risk mitigation

measures to protect the at-risk worker

population from potential eye irritation

and acute pulmonary effects. These

include goggles and appropriate dustmist filtering respirators which comply

with the Worker Protection Standards.

VIII. Other Considerations

A. Endocrine Disruptors

EPA does not have any information

regarding endocrine effects of this

microbial pesticide at this time. There is

no evidence to suggest that use of

Trichoderma harzianum strain T-39 at

the proposed concentrations will

adversely affect the endocrine system.

B. Analytical Method(s)

As part of the standard Quality

Control measures, the Agency is

requiring microbial assays and

analytical methods to identify the active

ingredient and potential contaminants.

Analytical methods are available and

sufficient to identify metabolites and

contaminants within regulatory levels.

All batches containing potential human

pathogens are to be destroyed.

C. Codex Maximum Residue Level

There are no Codex Maximum

Residue Levels or exemption from

tolerances for the microbial active

ingredient Trichoderma harzianum

strain T-39. There is an exemption from

tolerance on all food commodities

except mushrooms for another strain of

Trichoderma harzianum, Rifai strain

KRL-AG2, in the United States.

IX. Objections and Hearing Requests

Under section 408(g) of the FFDCA, as

amended by the FQPA, any person may

file an objection to any aspect of this

regulation and may also request a

hearing on those objections. The EPA

procedural regulations which govern the

38756 Federal Register / Vol. 65, No. 121 / Thursday, June 22, 2000 / Rules and Regulations

submission of objections and requests

for hearings appear in 40 CFR part 178.

Although the procedures in those

regulations require some modification to

reflect the amendments made to the

FFDCA by the FQPA of 1996, EPA will

continue to use those procedures, with

appropriate adjustments, until the

necessary modifications can be made.

The new section 408(g) provides

essentially the same process for persons

to ‘‘object’’ to a regulation for an

exemption from the requirement of a

tolerance issued by EPA under new

section 408(d), as was provided in the

old FFDCA sections 408 and 409.

However, the period for filing objections

is now 60 days, rather than 30 days.

A. What Do I Need to Do to File an

Objection or Request a Hearing?

You must file your objection or

request a hearing on this regulation in

accordance with the instructions

provided in this unit and in 40 CFR part

178. To ensure proper receipt by EPA,

you must identify docket control

number OPP–300924 in the subject line

on the first page of your submission. All

requests must be in writing, and must be

mailed or delivered to the Hearing Clerk

on or before August 21, 2000.

1. Filing the request. Your objection

must specify the specific provisions in

the regulation that you object to, and the

grounds for the objections (40 CFR

178.25). If a hearing is requested, the

objections must include a statement of

the factual issues(s) on which a hearing

is requested, the requestor’s contentions

on such issues, and a summary of any

evidence relied upon by the objector (40

CFR 178.27). Information submitted in

connection with an objection or hearing

request may be claimed confidential by

marking any part or all of that

information as CBI. Information so

marked will not be disclosed except in

accordance with procedures set forth in

40 CFR part 2. A copy of the

information 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.

Mail your written request to: Office of

the Hearing Clerk (1900), Environmental

Protection Agency, Ariel Rios Bldg.,

1200 Pennsylvania Ave., NW.,

Washington, DC 20460. You may also

deliver your request to the Office of the

Hearing Clerk in Room C–400,

Waterside Mall, 401 M St., SW.,

Washington, DC 20460. The Office of

the Hearing Clerk is open from 8 a.m.

to 4 p.m., Monday through Friday,

excluding legal holidays. The telephone

number for the Office of the Hearing

Clerk is (202) 260–4865.

2. Tolerance fee payment. If you file

an objection or request a hearing, you

must also pay the fee prescribed by 40

CFR 180.33(i) or request a waiver of that

fee pursuant to 40 CFR 180.33(m). You

must mail the fee to: EPA Headquarters

Accounting Operations Branch, Office

of Pesticide Programs, P.O. Box

360277M, Pittsburgh, PA 15251. Please

identify the fee submission be labeling

it ‘‘Tolerance Petition Fees.’’

EPA is authorized to waive any fee

requirement ‘‘when in the judgement of

the Administrator such a waiver or

refund is equitable and not contrary to

the purpose of this subsection.’’ For

additional information regarding the

waiver of these fees, you may contact

James Tompkins by phone at (703) 305–

5697, by e-mail at

tompkins.jim@epa.gov, or by mailing a

request for information to Mr. Tompkins

at Registration Division (7505C), Office

of Pesticide Programs, Environmental

Protection Agency, Ariel Rios Bldg.,

1200 Pennsylvania Ave., NW.,

Washington, DC 20460.

If you would like to request a waiver

of the tolerance objection fees, you must

mail your request for such a waiver to:

James Hollins, Information Resources

and Services Division (7502C), Office of

Pesticide Programs, Environmental

Protection Agency, Ariel Rios Bldg.,

1200 Pennsylvania Ave., NW.,

Washington, DC 20460.

3. Copies for the Docket. In addition

to filing an objection or hearing request

with the Hearing Clerk as described in

Unit VIII.A. of this preamble, you

should also send a copy of your request

to the PIRB for its inclusion in the

official record that is described in Unit

I.B.2. of this preamble. Mail your copies,

identified by docket number OPP–

300924, to: Public Information and

Records Integrity Branch, Information

Resources and Services Division

(7502C), Office of Pesticide Programs,

Environmental Protection Agency, Ariel

Rios Bldg., 1200 Pennsylvania Ave.,

NW., Washington, DC 20460. In person

or by courier, bring a copy to the

location of the PRIB described in Unit

I.B.2. of this preamble. You may also

send an electronic copy of your request

via e-mail to: opp-docket@epa.gov.

Please use an ASCII file format and

avoid the use of special characters and

any form of encryption. Copies of

electronic objections and hearing

requests will also be accepted on disks

in WordPerfect 6.1/8.0 file format or

ASCII file format. Do not include any

CBI in your electronic copy. You may

also submit an electronic copy of your

request at many Federal Depository

Libraries.

B. When Will the Agency Grant a

Request for a Hearing?

A request for a hearing will be granted

if the Administrator 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

issues(s) in the manner sought by the

requestor would be adequate to justify

the action requested (40 CFR 178.32).

X. Regulatory Assessment

Requirements

This final rule will establish an

exemption from the tolerance

requirement under FFDCA section

408(e). The Office of Management and

Budget (OMB) has exempted these types

of actions from review under Executive

Order 12866, entitled Regulatory

Planning and Review (58 FR 51735,

October 4, 1993). This action does not

contain any information collections

subject to OMB approval under the

Paperwork Reduction Act (PRA), 44

U.S.C. 3501 et seq., or impose any

enforceable duty or contain any

unfunded mandate as described under

Title II of the Unfunded Mandates

Reform Act of 1995 (UMRA) (Public

Law 104–4). Nor does it require any

prior consultation as specified by

Executive Order 13084, entitled

Consultation and Coordination with

Indian Tribal Governments (63 FR

27655, May 19,1998); special

considerations as required by Executive

Order 12898, entitled Federal Actions to

Address Environmental Justice in

Minority Populations and Low-Income

Populations (59 FR 7629, February 16,

1994); or require OMB review or any

Agency action under Executive Order

13045, entitled Protection of Children

from Environmental Health Risks and

Safety Risks (62 FR 19885, April 23,

1997). This action does not involve any

technical standards that would require

Agency consideration of voluntary

consensus standards pursuant to section

12(d) of the National Technology

Transfer and Advancement Act of 1995

(NTTAA), Public Law 104–113, section

12(d) (15 U.S.C. 272 note). Pursuant to

the Regulatory Flexibility Act (RFA) (5

U.S.C. 601 et seq.), the Agency

previously assessed whether

establishing tolerances, exemptions

from tolerances, raising tolerance levels

or expanding exemptions might

adversely impact small entities and

concluded, as a generic matter, that

Federal Register / Vol. 65, No. 121 / Thursday, June 22, 2000 / Rules and Regulations 38757

there is no adverse economic impact.

The factual basis for the Agency’s

generic certification for tolerance

actions published on May 4, 1981 (46

FR 24950), and was provided to the

Chief Counsel for Advocacy of the Small

Business Administration. In addition,

the Agency has determined that this

action will not have a substantial direct

effect on States, on the relationship

between the national government and

the States, or on the distribution of

power and responsibilities among the

various levels of government, as

specified in Executive Order 13132,

entitled Federalism (64 FR 43255,

August 10, 1999). Executive Order

13132 requires EPA to develop an

accountable process to ensure

‘‘meaningful and timely input by State

and local officials in the development of

regulatory policies that have federalism

implications.’’ ‘‘Policies that have

federalism implications’’ is defined in

the Executive Order to include

regulations that have ‘‘substantial direct

effects on the States, on the relationship

between the national government and

the States, or on the distribution of

power and responsibilities among the

various levels of government.’’ This rule

directly regulates growers, food

processors, food handlers and food

retailers, not States. This action does not

alter the relationships or distribution of

power and responsibilities established

by Congress in the preemption

provisions of FFDCA section 408(n)(4).

XI. Submission to Congress and the

General Accounting Office

The Congressional Review Act, 5

U.S.C. 801 et seq., as added by the Small

Business Regulatory Enforcement

Fairness Act of 1996, generally provides

that before a rule may take effect, the

agency promulgating the rule must

submit a rule report, which includes a

copy of the rule, to each House of the

Congress and to the Comptroller General

of the United States. EPA will submit a

report containing this rule and other

required information to the U.S. Senate,

the U.S. House of Representatives, and

the Comptroller General of the United

States prior to publication of this final

rule in the Federal Register. This final

rule is not a ‘‘major rule’’ as defined by

5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

Environmental protection,

Administrative practice and procedure,

Agricultural commodities, Pesticides

and pests, Reporting and recordkeeping

requirements.

Dated: May 25, 2000.

Susan B. Hazen,

Acting Director, Office of Pesticide Programs.

Therefore, 40 CFR chapter I is

amended as follows:

PART 180—[AMENDED]

1. The authority citation for part 180

continues to read as follows:

Authority: 21 U.S.C. 321(q), 346(a), and

371.

2. Section 180.1201 is revised to read

as follows:

§ 180.1201 Trichoderma harzianum strain

T-39; exemption from the requirement of a

tolerance.

Trichoderma harzianum strain T-39 is

exempt from the requirement of a

tolerance on all food commodities.

[FR Doc. 00–15723 Filed 6–21–00; 8:45 am]

BILLING CODE 6560–50–F

ENVIRONMENTAL PROTECTION

AGENCY

40 CFR Part 180

[OPP–301010; FRL–6592–4]

RIN 2070–AB78

Cloquintocet-mexyl; Pesticide

Tolerance

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Final rule.

SUMMARY: This regulation establishes

tolerances for the combined residues of

the inert ingredient (herbicide safener)

cloquintocet-mexyl and its acid

metabolite in or on wheat grain, forage,

hay, and straw. Novartis Crop

Protection, Inc. requested this tolerance

under the Federal Food, Drug, and

Cosmetic Act, as amended by the Food

Quality Protection Act of 1996.

DATES: This regulation is effective June

22, 2000. Objections and requests for

hearings, identified by docket control

number OPP–301010, must be received

by EPA on or before August 21, 2000.

ADDRESSES: Written objections and

hearing requests may be submitted by

mail, in person, or by courier. Please

follow the detailed instructions for each

method as provided in Unit VI. of the

SUPPLEMENTARY INFORMATION. To ensure

proper receipt by EPA, your objections

and hearing requests must identify

docket control number OPP–301010 in

the subject line on the first page of your

response.

FOR FURTHER INFORMATION CONTACT: By

mail: Treva Alston, Registration

Division (7505C), Office of Pesticide

Programs, Environmental Protection

Agency, 1200 Pennsylvania Ave., NW.,

Washington, DC 20460; telephone

number: 703–308–8373; and e-mail

address: alston.treva@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 Examples of potentially affected entities

Industry 111 Crop production

112 Animal production

311 Food manufacturing

32532 Pesticide manufacturing

This listing is not intended to be

exhaustive, 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’’ 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

OPP–301010. 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