19842 Federal Register / Vol. 61, No. 87 / Friday, May 3, 1996 / Rules and Regulations

Discussion of Regulation

This regulation is necessary to ensure

the safety of contestant and spectator

vessels involved with the 3rd Annual

Dana Point Challenge powerboat race.

The planned course of the race is

approximately one mile offshore and

extends from Capistrano Beach to San

Mateo Point, California. Many spectator

vessels (estimated 500–600 in 1995)

have previously attended this event. In

past years, contestants (approximately

20–25) had to speed around spectator

vessels which had wandered into the

race lanes. By deterring the large

amount of expected spectator vessel

traffic from entering into the designated

race lanes, the risk of high speed

collisions can be greatly reduced from

that of previous Dana Point Challenges.

This safety zone will be enforced by

U.S. Coast Guard personnel. The Coast

Guard Auxiliary, the Dana Point Harbor

Patrol and the Dana Point Challenge

event staff will assist in the enforcement

of the safety zone. Persons and vessels

are prohibited from entering into,

transiting through, or anchoring within

the Safety Zone unless authorized by

the Captain of the Port of his designated

representative.

Regulatory Evaluation

This rule is not a significant

regulatory action under section 3(f) of

Executive Order 12866 and does not

require an assessment of potential costs

and benefits under section 6(a)(3) of that

order. It has been exempted from review

by the Office of Management and

Budget under that order. It is not

significant under the regulatory policies

and procedures of the Department of

Transportation (44 FR 11040; February

26, 1979). The Coast Guard expects the

economic impact of this regulation to be

so minimal that a full Regulatory

Evaluation under paragraph 10(e) of the

regulatory policies and procedures of

the Department of Transportation is

unnecessary.

Collection of Information

This regulation contains no collection

of information requirements under the

Paperwork Reduction Act (44 U.S.C.

3501 et seq.).

Federalism

The Coast Guard has analyzed this

regulation under the principles and

criteria contained in Executive Order

12612, and has determined that this rule

does not have sufficient federalism

implications to warrant the preparation

of a Federalism Assessment.

Environmental Assessment

The Coast Guard has considered the

environmental impact of this regulation

and concluded that under section 2.B.2.

of Commandant Instruction M16475.1B

it will have no significant

environmental impact and it is

categorically excluded from further

environmental documentation. An

environmental analysis checklist has

been completed and a Marine Event

permit has been issued.

List of Subject in 33 CFR Part 165

Harbors, Marine safety, Navigation

(water), Reporting and recordkeeping

requirements, Security Measures,

Waterways.

Regulation

In consideration of the foregoing,

Subpart F of Part 165 of Title 33, Code

of Federal Regulations, is amended as

follows:

PART 165—[AMENDED]

1. The authority citation for 33 CFR

part 165 continues to read as follows:

Authority: 33 U.S.C. 1231; 50 U.S.C. 191;

33 CFR 1.05–1(g), 6.04–1, 6.04–6 and 160.5;

49 CFR 1.46.

2. A new section 165.T11–057 is

added to read as follows:

§ 165.T1157 Safety Zone: Dana Point, CA

(a) Location. The following area

constitutes a safety zone on the

navigable waters in the vicinity of

Capistrano Beach and San Mateo Point,

California, specifically:

North-West corner: 33°26.0′ N, 117°42.0′ W;

North-East corner: 33°27.0′ N, 117°41.3′ W;

North-East corner: 33°24.0′ N, 117°37.0′ W;

North-West corner: 33°23.2′ N, 117°38.0′ W.

This area measures approximately five

nautical miles by one nautical mile. (Datum:

NAD 83)

(b) Effective Date. This safety zone is

effective at 10 A.M. PDT and terminates

at 2 P.M. PDT on May 19, 1996 unless

canceled earlier by the Captain of the

Port.

(c) Regulations. The general

regulations governing safety zones

contained in 33 CFR 165.23 apply. No

person or vessel may enter or remain

within the safety zone without the

permission of the Captain of the Port

Los Angeles-Long Beach, California or

his designated representative.

Dated: April 24, 1996.

E. E. Page,

Captain, U.S. Coast Guard, Captain of the

Port, Los Angeles-Long Beach, California.

[FR Doc. 96–10998 Filed 5–2–96; 8:45 am]

BILLING CODE 4910–14–M

ENVIRONMENTAL PROTECTION

AGENCY

40 CFR Part 180

[PP 6F3333 and FAP2H5640/R2234; FRL–

5365–6]

RIN 2070–AB78

Cyromazine; Pesticide Tolerance

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Final Rule.

SUMMARY: This rule establishes a

tolerance for combined residues of the

insecticide cyromazine (N-cyclopropyl1,3,5-triazine-2,4,6-triamine) and its

major metabolite melamine, 1,3,5-

triazine-2,4-6-triamine calculated as

cyromazine in or on the raw agricultural

commodity (RAC) tomato. The

regulation to establish a maximum

permissible level for residues of the

insecticide was requested in a petition

submitted by the CIBA-Geigy

Corporation, P.O. Box 18300,

Greensboro, NC 27419.

EFFECTIVE DATE: This regulation

becomes effective May 3, 1996.

ADDRESSES: Written objections and

hearing requests, identified by the

document control number, [PP 6F3333

and FAP2H5640/R2234], 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

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 must be identified by

the docket number [PP 6F3333 and
Federal Register / Vol. 61, No. 87 / Friday, May 3, 1996 / Rules and Regulations 19843

FAP2H5640/R2234]. 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: George LaRocca, Product Manager

(PM) [13], Registration Division (7505C),

Office of Pesticide Programs,

Environmental Protection Agency, 401

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

Office location and telephone number:

Rm. 204, CM#2, 1921 Jefferson Davis

Highway, Arlington, VA 22202. (703)

305-6100; e-mail:

glarocca@epamail.epa.gov

SUPPLEMENTARY INFORMATION: In the

Federal Register of March 19, 1986 (51

FR 9511) and June 10, 1992 (57 FR

2467) EPA issued notices of filing which

announced that Ciba-Geigy Corp.

(CIBA), P.O. Box 18300, Greensboro, NC

27419 had submitted pesticide petition

(PP 6F3333) and Food/Feed Additive

Petition (FAP) 2H5640 to EPA

proposing to amend 40 CFR 180.414 by

establishing a tolerance under section

408 (d) of the Federal Food, Drug, and

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

for residues of the insecticide

cyromazine (N-cyclopropyl-1,3,5-

triazine-2,4,6-triamine) plus its major

metabolite melamine, 1,3,5-triazine-2,4-

6-triamine calculated as cyromazine in

or on the raw agricultural commodity

tomato at 1.0 parts per million (ppm)

and proposing to amend 40 CFR parts

185 and 186 by establishing a food/feed

additive regulation under section 409(e)

of FEDCA 21 U.S.C. 348(b) for combined

residues of cyromazine and its

metabolite in/on processed tomato

products at 1.2 ppm and dried tomato

pomace at 1.6 ppm. Further in the

Federal Register of March 10, 1993 (58

FR 13261), Ciba amended PP 6F3333 by

lowering the tolerance for combined

residues of the insecticide cyromazine

plus its metabolite melamine, in or on

the raw agricultural commodity tomato

from 1.0 ppm to 0.5 ppm. The petitions

for tomato and processed tomato

products were again amended in the

Federal Register of October 25, 1995 (60

FR 54689) by proposing to raise the

tolerance in tomatoes to 1.0 ppm and

proposing tolerances in or on processed

tomato products (excluding juice) at 2.5

ppm and tomato pomace, wet and dry

at 2.5 ppm. In addition Ciba proposed

to amend 40 CFR 180.414 by:

(1) Establishing separate tolerances for

residues of cyromazine and its major

metabolite melamine, calculated as

cyromazine, in meat, fat, and meat byproducts (including liver and kidney) of

cattle, goats, hogs, horses, and sheep at

0.05 ppm and milk at 0.02 ppm under

Sections 180.414(b) and (c) respectively.

(2) Establish as a separate tolerance

for residues of the metabolite 1-

methylcyromazine (1-methyl-Ncyclopropyl-1,3,5-triazine-2,4,6-

triamine), calculated as cyromazine, in

liver and kidney of cattle, goats, hogs,

horses and sheep at 0.05 ppm, and

(3) Amending the established

tolerances for cyromazine and melamine

in or on fat, meat and meat-by-products

of chickens, under 40 CFR 180.414 (b)

and (c) by removal of the restriction

‘‘from chicken layer hens and chicken

breeder hens only’’.

There were no comments or requests

for referral to an advisory committee

received in response to these notices of

filing.

The scientific data submitted in the

petition and other relevant material

have been evaluated. A discussion of

the toxicological data considered in

support of the tolerance as well as a

discussion of the risk of cyromazine and

its metabolite melamine can be found in

a rule (FAP 2H5355/P344) published in

the Federal Register of April 27, 1984

(48 FR 18120); in the Notice of

Conditional Registration for Larvadex

0.3% Premix, published in the Federal

Register of May 15, 1985 (50 FR 20373);

and in the proposed rule regarding the

establishment of a tolerance for residues

of cyromazine and its metabolite

melamine, calculated as cyromazine, in

or on mushroom at 10.0 ppm in the

Federal Register of June 30, 1993 (58 FR

34972).

A chronic dietary exposure/risk

assessment has been performed for

cyromazine using a reference dose (RfD)

of 0.0075 mg/kg bwt/day. The reference

dose is based on the no-observableeffect-level (NOEL) of 0.75 mg/kg bwt/

day from a 6–month dog feeding study

with an uncertainty factor (UF) of 100

that demonstrated decreased hematocrit

and hemoglobin levels. Granting the

tolerance on tomato will increase the

theoretical maximum residue

contribution (TMRC) for the overall

(average) U.S. population for

cyromazine from 0.001788 mg/kg/day to

0.002011 mg/kg/day. The percentage of

the RfD used is increased from 24

percent to approximately 26.8%.

Generally speaking the Agency has no

concern if dietary exposure is less than

the Rfd for all published and proposed

tolerances.

Cyromazine was previously classified

by the Agency as a Group C-possible

human carcinogen, with the Reference

Dose (RfD) methodology recommended

for estimation of human risk (see the

Federal Register of June 30, 1993 (58 FR

34972)). Ciba subsequently submitted a

reexamination (by a reviewing

pathologist and a pathology working

group) of the tissues from the

cyromazine chronic feeding and

carcinogenicity studies in both rat and

mouse. Based on a review of this

information by the Health Effects

Division Carcinogenicity Peer Review

Committee (CPRC) of the Office of

Pesticide Programs, the Agency has

determined that cyromazine should be

reclassified to Group E-no evidence for

carcinogenicity in humans. The

consensus of the CPRC was that the

reexamination of mammary gland

tissues in the mouse and rat was

performed in an acceptable manner and

based on these revised data, there were

no statistically significant increases in

tumors in the treated groups, and there

were no statistically significant trends.

Therefore, the classification of

cyromazine has been revised to Group E

in accordance with Agency guidelines,

published in the Federal Register of

September 24, 1986 (51 FR 33992).

The Agency has modified and

updated its policy concerning whether

concentration occurs in processed

foods. In the past, EPA has found that

a food additive tolerance (section 409) is

necessary whenever a pesticide

concentrates in the processed food (i.e.,

the levels in parts per million are greater

in the processed food than in the raw

food). The National Food Processors

Association (NFPA) raised a number of

concerns with the Agency’s traditional

approach to determining whether

concentration occurs. EPA concluded

that modifications can be made to its

policy to ensure better predictions of

concentration. Although information

from processing studies will remain the

most important information in

determining whether concentration

occurs EPA will now also take into

account information concerning mixing

and blending of crops information

pertaining to average residues.

As a result of this change in policy the

Agency has reevaluated the processing

data for tomato and has concluded that

a food additive tolerance is not needed

for cyromazine residues including the

metabolite melamine in processed

tomato products. Tolerances are needed

to prevent processed foods from being

deemed adulterated when the processed

food when ready to eat contains a

pesticide residue at a level greater than

permitted by the corresponding section

408 tolerance 21 U.S.C. 342(a)(2). In

1993, EPA had concluded that a 409

tolerance for processed tomato products

was needed due to a processing study
19844 Federal Register / Vol. 61, No. 87 / Friday, May 3, 1996 / Rules and Regulations

that showed levels of cyromazine in

tomato paste (the tomato byproduct

with the highest concentration) 2.2

times the level in tomato (i.e., a

concentration factor 2.2X). However,

other processing studies showed that

processing tomato paste resulted in a

reduction of cyromazine residues or a

lower concentration factor than 2.2X. In

accordance with the Agency’s revised

concentration policy when the results

from all processing studies for tomato

paste were averaged, the concentration

factor was lowered to 1X. Given the

variability in analytical methods and

this lower concentration factor, EPA

believes that it is unlikely that any

tomato paste or other processed tomato

products derived from tomatoes

containing legal levels of cyromazine

could be reliably determined to have

levels of cyromazine above the tomato

tolerance. Because it is unlikely that

processed tomato products will have

levels of cyromazine above the section

408 tolerance, no section 409 tolerance

is needed. In a letter dated November

21, 1995 Ciba requested withdrawal of

the food additive proposal in processed

tomato products.

In the same November 21, 1995 letter

Ciba also requested withdrawal of the

feed additive proposal in or on tomato

pomaces; withdrawal of tolerance for

cyromazine and melamine in milk,

meat, fat and meat byproducts of cattle,

goats, hogs, horses and sheep;

withdrawal of the tolerance for the

metabolite, 1-methycyromazine in the

liver and kidney of cattle, goats, hogs,

horses and sheep and withdrawal of the

request to remove the restriction ‘‘from

chicken layer and breeder hens only’’.

Ciba’s withdrawal of these tolerances

were submitted in response to EPA’s

latest revision (unpublished) to Table II

(September 1995) of the Pesticide

Assessment Guidelines, Subdivision O

(Residue Chemistry) titled Raw

Agricultural and Processed

Commodities and Livestock Feeds

Derived from Field Crops and Ciba’s

voluntary withdrawal of a companion

proposed tolerance request for use of

cyromazine and its metabolite melamine

in or on carrot (PP 6F3329)(See 60 FR

54689, October 25, 1995). With respect

to the feed additive proposal for tomato

pomace EPA has concluded that tomato

pomaces (wet and dry) are no longer

considered feedstuffs. Withdrawal of the

proposed use of cyromazine on carrot

eliminated potential residues from the

feedstuff carrot culls. Thus based upon

the decision that tomato pomaces are no

longer feedstuffs and withdrawal of the

carrot tolerance (carrot culls), feed

additive tolerances in animal

commodities are not necessary for this

proposed use.

An adequate analytical method, AG584A, is available for enforcement

purposes.

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 6F3333 and FAP2H5640/R2234]

(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.

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. In

addition, 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 considerations as required by

Executive Order 12898 (59 FR 7629,

February 16, 1994).

Pursuant to the requirements of the

Regulatory Flexibility Act (Pub. L. 96–
Federal Register / Vol. 61, No. 87 / Friday, May 3, 1996 / Rules and Regulations 19845

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: April 18, 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 § 180.414 the table in paragraph

(e) is amended by adding alphabetically

the following raw agricultural

commodity:

§ 180.414 Cyromazine; tolerances for

residues.

* * * * *

Commodity Parts per

million

* * * * *

Tomato ...................................... 1.0

[FR Doc. 96–10922 Filed 5–2–96; 8:45 am]

BILLING CODE 6560–50–F

40 CFR Part 180

[PP 2F4111/R2226; FRL–5360–3]

RIN 2070–AB78

Pesticide Tolerance for Iprodione

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Final rule.

SUMMARY: This rule establishes a timelimited tolerance for the combined

residues of the fungicide iprodione in or

on the raw agricultural commodity

cottonseed. The regulation to establish a

maximum permissible level for residues

of iprodione was requested in a petition

submitted by Rhone-Poulenc Ag

Company.

EFFECTIVE DATE: This regulation

becomes effective March 18, 1996.

ADDRESSES: Written objections and

hearing requests, identified by the

document control number, [PP 2F4111/

R2226], may be submitted to: Hearing

Clerk (1900), Environmental Protection

Agency, Rm. M3708, 401 M St., SW.,

Washington, DC 20460. Fees

accompanying objections and hearing

requests shall be labeled ‘‘Tolerance

Petition Fees’’ and forwarded to: EPA

Headquarters Accounting Operations

Branch, OPP (Tolerance Fees), P.O. Box

360277M, Pittsburgh, PA 15251. 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.

A copy of objections and hearing

requests filed with the Hearing Clerk

may also be submitted electronically by

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

objections and hearing requests must be

submitted as an ASCII file avoiding the

use of special characters and any form

of encryption. Copies of objections and

hearing requests will also be accepted

on disks in WordPerfect in 5.1 file

format or ASCII file format. All copies

of objections and hearing requests in

electronic form must be identified by

the docket number [PP 2F4111/R2226].

No Confidential Business Information

(CBI) should be submitted through email. Electronic copies of 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)

305-6900; e-mail:

welch.connie@epamail.epa.gov.

SUPPLEMENTARY INFORMATION: RhonePoulenc Ag Co., P.O. Box 12014,2 T.W.

Alexander Drive, Research Triangle

Park, NC 27709, has submittedpesticide

petition (PP) 2F4111 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

the combined residues of the fungicide

iprodione, [3-(3,5-dichlorophenyl)-N-(1-

methylethyl)-2,4-dioxo-1-

imidazolidinecarboxamide], its isomer

[3-(1-methylethyl)-N-(3,5-

dichlorophenyl)-2,4-dioxo-1-

imidazolidinecarboxamide], and its

metabolite [3-(3,5-dichlorophenyl)-2,4-

dioxo-1-imidazolidinecarboxamide], in

or on the raw agricultural commodity

cottonseed at 0.10 parts per million

(ppm).

Through an oversight, an

announcement of receipt of this petition

by the Agency was not published in the

Federal Register as required by

regulation in 40 CFR 177.88. In lieu of

the 30-day comment period prior to

establishing the tolerance requested,

this tolerance is being established with

the provision that any comments

received within 30 days after

publication in the Federal Register

which contain objections will be

reviewed and if the objections are

substantial, the tolerance will be

withdrawn, if justified. The publication

of this notice is deemed to be in the

public interest and is justified by the

fact that the resulting changes in the use

pattern for iprodione, which resulted

from an agreement between RhonePoulenc Ag Co. and the Agency, will

significantly lower the overall use of

iprodione and consequently reduce the

risk to the public posed by its current

uses.

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. A three-generation rat reproduction

study using dosage levels of 0, 250, 500

and 2,000 ppm with a no-observedeffect level (NOEL) of 500 ppm (25

milligrams/kilogram(mg/kg) body

weight (bwt)/day), a reproductive lowest

effect level (LEL) of 2,000 ppm (100 mg/

kg/day), and a systemic NOEL equal to

or greater than 2,000 ppm (100 mg/kg/

day).

2. A rabbit developmental toxicity

study in which the following doses were

administered by gavage; 0, 20, 60, and

200 mg/kg bwt, resulting in a

developmental toxicity NOEL equal to

or greater than 60 mg/kg bwt, and an

LEL of 200 mg/kg bwt.

3. A rat developmental toxicity study

in which the following doses were

administered by gavage: 0, 40, 90, and