Federal Register / Vol. 61, No. 124 / Wednesday, June 26, 1996 / Rules and Regulations 33041

impacts that this regulatory action may

impose on small entities should be

submitted to the Agency at the address

listed under the ADDRESSES unit.

C. Paperwork Reduction Act

The information collection

requirements contained in this rule have

been previously approved by the Office

of Management and Budget under the

provisions of the Paperwork Reduction

Act of 1980, 44 U.S.C. 3501 et seq. and

have been assigned OMB Control No.

2070-0060. A copy may be obtained

from the Information Policy Branch

(7405), EPA, 401 M St., SW.,

Washington, DC 20460, or by calling

(202) 260-2744.

D. Unfunded Mandates

Under Title II of the Unfunded

Mandates Reform Act of 1995 (Pub. L.

104-4), this action does not result in the

expenditure of $100 million or more by

any State, local or tribal governments, or

by anyone in the private sector, and will

not result in any ‘‘unfunded mandates’’

as defined by Title II. The costs

associated with this action are described

in the Executive Order 12866 unit

above.

Under Executive Order 12875 (58 FR

58093, October 28, 1993), EPA must

consult with representatives of affected

State, local, and tribal governments

before promulgating a discretionary

regulation containing an unfunded

mandate. This action does not contain

any mandates on States, localities or

tribes and is therefore not subject to the

requirements of Executive Order 12875.

E. Submission to Congress and the

General Accounting Office

Under 5 U.S.C. 801(a)(1)(A) of the

Administrative Procedure Act (APA) as

amended by the Small Business

Regulatory Enforcement Fairness Act of

1996 (Title II of Pub. L. 104-121, 110

Stat. 847), EPA submitted 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 General

Accounting Office prior to publication

of the rule in today’s Federal Register.

This rule is not a ‘‘major rule’’ as

defined by 5 U.S.C. 804(2) of the APA

as amended.

List of Subjects in Part 152

Environmental protection,

Administrative practice and procedure,

Pesticides and pests, Reporting and

recordkeeping requirements.

Dated: June 20, 1996.

Carol M. Browner,

Administrator.

Therefore, 40 CFR part 152 is

amended as follows:

PART 152—[AMENDED]

1. The authority citation for part 152

continues to read as follows:

Authority: 7 U.S.C. 136-136y; subpart U is

also issued under 31 U.S.C. 9701.

2. Section 152.44 is amended by

adding new paragraph (b)(4), to read as

follows:

§ 152.44 Applications for amended

registration.

* * * * *

(b) * * *

(4) Permit an applicant to modify a

registration by notification or nonnotification in accordance with

§ 152.46.

3. Section 152.46 is revised to read as

follows:

§ 152.46 Notification and non-notification

changes to registrations.

(a) Changes permitted by notification.

(1) EPA may determine that certain

minor modifications to registration

having no potential to cause

unreasonable adverse effects to the

environment may be accomplished by

notification to the Agency, without

requiring that the registrant obtain

Agency approval. If EPA so determines,

it will issue procedures following an

opportunity for public comment

describing the types of modifications

permitted by notification and any

conditions and procedures for

submitting notifications.

(2) A registrant may modify a

registration consistent with paragraph

(a)(1) of this section and any procedures

issued thereunder and distribute or sell

the modified product as soon as the

Agency has received the notification.

Based upon the notification, the Agency

may require that the registrant submit

an application for amended registration.

If it does so, the Agency will notify the

registrant and state its reasons for

requiring an application for amended

registration. Thereafter, if the registrant

fails to submit an application the

Agency may determine that the product

is not in compliance with the

requirements of the Act. Notification

under this paragraph is considered a

report filed under the Act for the

purposes of FIFRA section 12(a)(2)(M).

(b) Changes permitted without

notification. EPA may determine that

certain minor modifications to

registration having no potential to cause

unreasonable adverse effects to the

environment may be accomplished

without notification to or approval by

the Agency. If EPA so determines, it will

issue procedures following an

opportunity for public comment

describing the types of amendments

permitted without notification (also

known as non-notification). A registrant

may distribute or sell a product changed

in a manner consistent with such

procedures without notification to or

approval by the Agency.

(c) Effect of non-compliance.

Notwithstanding any other provision of

this section, if the Agency determines

that a product has been modified

through notification or without

notification in a manner inconsistent

with paragraphs (a) or (b) of this section

and any procedures issued thereunder,

the Agency may initiate regulatory and/

or enforcement action without first

providing the registrant with an

opportunity to submit an application for

amended registration.

[FR Doc. 96–16335 Filed 6–25–96; 8:45 am]

BILLING CODE 6560–50–F

40 CFR Parts 180 and 185

[PP 4F4380 and FAP 4H5703/R2240; FRL–

5369–7]

RIN 2070–AB78

Flutolanil; Pesticide Tolerance

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Final rule.

SUMMARY: This rule establishes a timelimited tolerance, to expire on April 30,

1998 for combined residues of the

fungicide flutolanil N-(3-(1-

methylethoxy)phenyl)-2-

(trifluoromethyl)benzamide and its

metabolites converted to 2-

(trifluoromethyl) benzoic acid and

calculated as flutolanil in or on the raw

agricultural commodities rice grain at

2.0 ppm and rice straw at 8.0 ppm; and

in or on the processed food

commodities rice hull at 7.0 ppm and

rice bran at 3.0 ppm, when present

therein as a result of application of the

fungicide to growing crops. The

regulation to establish a maximum

permissible level for residues of the

fungicide was requested in a petition

submitted by the AgrEvo USA

Company.

EFFECTIVE DATE: This regulation became

effective April 30, 1996.

ADDRESSES: Written objections and

hearing requests, identified by the

document control number, [PP 4F4380,

FAP 4H5703/R2240], may be submitted
33042 Federal Register / Vol. 61, No. 124 / Wednesday, June 26, 1996 / Rules and Regulations

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 copy of objections and

hearing requests 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.

An electronic copy of objections and

hearing requests filed with the Hearing

Clerk may be submitted to OPP by

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

Copies of electronic objections and

hearing requests must be submitted as

an ASCII file avoiding 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 5.1 file format

or ASCII file format. All copies of

electronic objections and hearing

requests must be identified by the

docket number [PP 4F4380, FAP

4H5703/R2240] . No Confidential

Business Information (CBI) should be

submitted through e-mail. Copies of

electronic objections and hearing

requests on this rule may be filed online

at many Federal Depository Libraries.

Additional information on electronic

submissions can be found below in this

document.

FOR FURTHER INFORMATION CONTACT: By

mail: Connie B. Welch, Product

Manager (PM) 21, Registration Division

(7505C), Office of Pesticide Programs,

Environmental Protection Agency, 401

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

Office location and telephone number:

Rm. 227, CM#2, 1921 Jefferson Davis

Highway, Arlington, VA 22202 (703)

305-6226; e-mail:

welch.connie@epamail.epa.gov.

SUPPLEMENTARY INFORMATION: EPA

issued a notice (FRL–4926–4),

published in theFederal Register of

February 8, 1995 (60 FR 7539), which

announced that AgrEvo USA Company

had submitted pesticide petitions (PP)

4F4380 and FAP 4H5703 to EPA

requesting that the Administrator,

pursuant to section 408(d) of the Federal

Food, Drug, and Cosmetic Act (FFDCA),

21 U.S.C. 346a(d), establish a tolerance

for combined residues of the fungicide

flutolanil N-(3-(1-methylethoxy)phenyl)-

2-(trifluoromethyl)benzamide and its

metabolites converted to 2-

(trifluoromethyl) benzoic acid and

calculated as flutolanil, in or on the raw

agricultural commodities rice grain at

2.0 ppm and rice straw at 8.0 ppm; and

in or on the processed food

commodities rice hull at 7.0 ppm and

rice bran at 3.0 ppm, when present

therein as a result of application of the

fungicide to growing crops.

There were no comments received in

response to the notice of filing. The

scientific data submitted in the petition

and other relevant material have been

evaluated. The toxicological data

considered in support of the tolerance

include:

1. Several acute toxicity studies that

place technical flutolanil in Toxicity

Category III (Caution). Data show

minimal to slight irritation to the eye.

2. A 90–day rat feeding study with a

systemic no-observed effect level

(NOEL) of 37 mg/kg/day for males and

44 mg/kg/day for females and a systemic

lowest effect level (LEL) of 299 mg/kg/

day for males and 339 mg/kg/day for

females based on increased absolute and

relative liver weights in both the 299

mg/kg/day males and 339 mg/kg/day

females and the 1,512 mg/kg/day males

and 1,743 mg/kg/day females, along

with a slight decrease in body weight in

1,512 mg/kg/day males.

3. A 90–day oral study in dogs with

a systemic NOEL of 80 mg/kg/day and

a systemic LEL of 400 mg/kg/day based

on enlarged livers and increased

glycogen deposition in the livers of both

males and females. High dose (2,000

mg/kg/day) males and females showed

increased alkaline phosphatase levels

and cholesterol thyroid/parathyroid

organ weights.

4. A 2–year feeding/carcinogenicity

study in rats with a systemic NOEL of

86.9 mg/kg/day for males and 103.1 mg/

kg/day for females and a systemic LEL

of 460.5 mg/kg/day for males and 535.8

mg/kg/day for females based on reduced

body weight and body weight gain in

males along with decreased and

absolute relative weights in females.

Flutolanil was not carcinogenic under

the conditions of this study.

5. A carcinogenicity study in mice

with a systemic NOEL of 735 mg/kg/day

for males and 1,168 mg/kg/day for

females and a systemic LEL of 13,333

mg/kg/day for males and 1,839 mg/kg/

day for females based on body weight

gains in the high dose females which

were significantly lower than those of

controls during the first 24 weeks of

treatment. There were no effects of

biological importance on survival,

clinical signs, food intake, hematology,

gross pathology, or histopathology.

Flutolanil was not carcinogenic under

the conditions of this study.

6. A 2–year oral feeding study in dogs

with a systemic NOEL of 50 mg/kg/day

for males and females and a systemic

LEL of 250 mg/kg/day based on

increased incidence of clinical signs

(emesis, salivation, soft stools, lower

body weight gains and decreased food

consumption in the 250 and 1,250 mg/

kg group males and females.

7. A rat developmental toxicity study

with a maternal NOEL of 1,000 mg/kg/

day (limit dose) and a developmental

toxicity NOEL of 1,000 mg/kg/day (limit

dose). Developmental toxicity was not

observed at any dose level.

8. A rabbit developmental toxicity

study with a maternal NOEL of 40 mg/

kg/day and a maternal LEL of 200 mg/

kg/day based on increased resorptions

in the 200 and 1,000 mg/kg group. A

developmental NOEL of 40 mg/kg/day,

and a developmental LEL of 200 mg/kg/

day were based on increased resorptions

in the 200 and 1,000 mg/kg/day group.

9. A 2–generation rat reproduction

study with a parental toxicity NOEL of

1,936 mg/kg/day (limit dose) and a

reproductive toxicity NOEL of 1,936

mg/kg/day (limit dose).

10. Mutagenicity studies included: An

Ames Assay which was negative;

Chromosome Aberration studies which

showed flutolanil induced chromosomal

aberrations in cultured Chinese Hamster

lung cells in the presence of metabolic

activation; Reverse Data which showed

that flutolanil did not cause an increase

in revertant colonies using Salmonella

and E.coli strains; Micronucleus Assay

data which indicated that flutolanil, up

to a dose of 10 gm/kg, did not induce

micronuclei in the bone marrow

erythrocytes of male and female mice;

Unscheduled DNA Synthesis (UDS) data

which showed that flutolanil did not

induce UDS because the test compound

failed to induce a genotoxic response in

the in vitro assay; and Lymphoma

mutation test data which showed that

flutolanil was found to be nonmutagenic

in the Mammalian Cell Gene Mutation

Assay.

The Reference Dose (RfD) used in the

analysis is 0.2 mg/kg bwt/day, based on

an LEL of 63.7 mg/kg bwt/day from a

three generation rat reproductive study

with an uncertainty factor of 300 that

demonstrated decreased body weight

gains and increased liver weights at the

high dose of 661.8 mg/kg. Flutolanil is

classified as a group E carcinogen,

showing no evidence of cancer in rats or

mice.

The Theoretical Maximum Residue

Contribution (TMRC) from the current
Federal Register / Vol. 61, No. 124 / Wednesday, June 26, 1996 / Rules and Regulations 33043

action is estimated at 0.000810 mg/kg

bwt/day and utilizes less than 1 percent

of the RfD for the general population of

the 48 States. The TMRCs for the most

highly exposed subgroups, children (1

to 6 years old) is 0.003577 mg/kg bwt/

day (1.8% of the RfD).

The residue analytical method will

not be forwarded to FDA for publication

at this time. This method is available for

limited distribution from Calvin Furlow,

Public Response and Program Resources

Branch, Field Operations Division

(7506C), Office of Pesticide Programs,

Environmental Protection Agency, 401

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

Office location and telephone number:

Rm. 1132, CM #2, 1921 Jefferson Davis

Highway, Arlington, VA 22202 (703)

305–5232. It has the following

disclaimer: The method is for use only

by experienced chemists who have

demonstrated knowledge of the

principles of trace organic analysis; and

have proven skills and abilities to run

a complex residue analytical method

obtaining accurate results at the part per

billion level. Users of this method are

expected to perform additional method

validation prior to using the method for

either monitoring or enforcement. The

method can detect gross misuse.

There are presently no actions

pending against the continued

registration of this chemical. The

pesticide is considered useful for the

purpose for which the tolerance is

sought.

Based on the information and data

considered, the Agency has determined

that the tolerance established by

amending 40 CFR part 180 will protect

the public health. Therefore, the

tolerance is established 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

to the regulation and may also request

a hearing on those objections.

Objections and hearing requests must be

filed 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 such issues,

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 Administrator determines that the

material submitted shows the following:

There is 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 manner sought by the

requestor would be adequate to justify

the action requested (40 CFR 178.32).

A record has been established for this

rulemaking under the docket number

[PP 4F4380 FAP 5H5703/R2240]

(including any comments and data

submitted electronically). 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 a.m. to 4:30 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 22202.

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

rulemaking, as well as the public

version, as described above will be kept

in paper form. Accordingly, EPA will

transfer any copies of objections and

hearing requests received electronically

into printed, paper form as they are

received and will place the paper copies

in the official rule-making record which

will also include all comments

submitted directly in writing. The

official rulemaking record is the paper

record maintained at the address in

‘‘ADDRESSES’’ at the beginning of this

document.

Under Executive Order 12866 (58 FR

51735, October 4, 1993), the Agency

must determine whether the regulatory

action is ‘‘significant’’ and therefore

subject to all the requirements of the

Executive Order (i.e., Regulatory Impact

Analysis, review by the Office of

Management and Budget (OMB)). Under

section 3(f), the order defines

‘‘significant’’ as those actions likely to

lead to 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 known 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 (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 this

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. 9–

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 explaining the factual basis

for this determination was published in

the Federal Register of May 4, 1981 (46

FR 24950).

Under 5 U.S.C. 801(a)(1)(A) of the

Administrative Procedure Act (APA) as

amended by the Small Business

Regulatory Enforcement Fairness Act of

1996 (Title II of Pub. L. 104–121, 110

Stat. 847), EPA submitted 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 General

Accounting Office prior to publication

of the rule in today’s Federal Register.

This rule is not a ‘‘major rule’’ as

defined by 5 U.S.C. 804(2) of the APA

as amended.

This action does not impose any

enforceable duty, or contain any

‘‘unfunded mandates’’ as described in

Title II of the Unfunded Mandates

Reform Act of 1995 (Pub. L. 104–4), or

require prior consultation as specified

by Executive Order 12875 (58 FR 58093,

October 28, 1993), entitled Enhancing

the Intergovernmental Partnership, or

special consideration as required by

Executive Order 12898 (59 FR 7629,

February 16, 1994).

List of Subjects

40 CFR Part 180

Environmental protection,

Administrative practice and procedure,

Agricultural commodities, Pesticides
33044 Federal Register / Vol. 61, No. 124 / Wednesday, June 26, 1996 / Rules and Regulations

and pests, Reporting and recordkeeping

requirements.

40 CFR Part 185

Food additive, Pesticide and pest.

Dated: April 30, 1996.

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.

2. In § 180.484 by designating the

existing text as paragraph (a) and by

adding a new paragraph (b) to read a

follows:

§ 180.484 Flutolanil N-(3-(1-

methylethoxy)phenyl)-2-

(trifluoromethyl)benzamide and its

metabolites converted to 2-(trifluoromethyl)

benzoic acid and calculated as flutolanil;

tolerances for residues.

* * * * *

(b) Time-limited tolerances are

established for the combined residues of

the fungicide flutolanil N-(3-(1-

methylethoxy)phenyl)-2-

(trifluoromethyl)benzamide and its

metabolites converted to 2-

(trifluoromethyl) benzoic acid and

calculated as flutolanil in or on the

following raw agricultural commodities:

Commodities Parts per

million Expiration date

Rice, grain .................................................................................................................................................... 2.0 April 30, 1998

Rice, straw .................................................................................................................................................... 8.0 April 30, 1998

PART 185—[AMENDED]

2. In part 185

a. The authority citation for part 185

continues to read as follows:

Authority: 21 U.S.C. 346a and 371.

b. In § 185.3385 by designating the

existing text as paragraph (a) and by

adding a new paragraph (b) to read as

follows:

§ 185.3385 Flutolanil N-(3-(1-

methylethoxy)phenyl)-2-

(trifluoromethyl)benzamide and its

metabolites converted to 2-(trifluoromethyl)

benzoic acid and calculated as flutolanil;

tolerances for residues.

* * * * *

(b) A time-limited food additive

regulation is established permitting the

combined residues of the fungicide

flutolanil N-(3-(1-methylethoxy)phenyl)-

2-(trifluoromethyl)benzamide and its

metabolites converted to 2-

(trifluoromethyl) benzoic acid and

calculated as flutolanil in or on the

following raw processed food

commodity:

Commodities Parts per

million Expiration date

Rice, hull ....................................................................................................................................................... 7.0 April 30, 1998

Rice, bran ..................................................................................................................................................... 3.0 April 30, 1998

[FR Doc. 96–16338 Filed 6–25–96; 8:45 am]

BILLING CODE 6560–50–F

40 CFR Part 799

[OPPTS–00173A; FRL–5379–5]

Technical Amendments to TSCA

Regulations to Update Addresses;

Correction

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Correction to final rule.

SUMMARY: EPA issued a final rule

document (FR Doc. 95–16287)

published in the Federal Register of

July 3, 1995 (60 FR 34462) (FRL–4964–

5), inadvertently amending § 799.1285.

This document removes that

amendment. Section 799.1285 was

removed at 60 FR 31924, June 19, 1995

(FRL–4955–2). Because this is a

nonsubstantive change, notice and

public comment are not required.

EFFECTIVE DATE: July 3, 1995.

FOR FURTHER INFORMATION CONTACT:

Susan B. Hazen, Director,

Environmental Assistance Division

(7408), Office of Pollution Prevention

and Toxics, Environmental Protection

Agency, 401 M St., NW, Washington,

DC 20460, telephone: (202) 554–1404,

TDD: (554–0551); e-mail: TSCA Hotline@epamail.epa.gov.

SUPPLEMENTARY INFORMATION:

In FR Doc. 95–16287 published in the

Federal Register of July 3, 1995 (60 FR

34462), § 799.1285 was inadvertently

amended. EPA issued a document in the

Federal Register of June 19, 1995 (60 FR

31924) removing § 799.1285. This

document removes the amendment

published on July 3, 1995.

List of Subjects in 40 CFR Part 799

Environmental protection, Chemicals,

Hazardous substances, and Reporting

and recordkeeping requirements.

Correction of Publication

Accordingly, the publication on July

3, 1995, of the final regulation, which

was the subject of FR Doc. 95–16287, is

corrected as follows:

§ 799.1285 [Corrected]

In the final rule published on July 3,

1995, at 60 FR 34462, make the

following correction. On page 34467, in

the first column, remove amendatory

instruction c. and the amendment to

§ 799.1285.

Dated: June 14, 1996.

William H. Sanders, III

Director, Office of Pollution Prevention and

Toxics.

[FR Doc. 96–16199 Filed 6–25–96; 8:45 am]

BILLING CODE 6560–50–F