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
19846 Federal Register / Vol. 61, No. 87 / Friday, May 3, 1996 / Rules and Regulations

200 mg/kg bwt, with a developmental

toxicity NOEL equal to or greater than

90 mg/kg bwt, and an LEL of 200 mg/

kg bwt.

4. A 24-month feeding/oncogenicity

study in rats using dosage levels of 125,

250 and 1,000 ppm (6.25, 12.5 and 50

mg/kg/day) which showed no treatmentrelated tumors were reported but

testicular intersticial cell tumors were

observed.

5. A repeated 24-month rat feeding

study at dose levels of 0, 150, 300 and

1,600 ppm which showed nonneoplastic changes such as intersticial

cell hyperplasia in the testes of males

and tubular hyperplasia in the ovaries

and increased sciatic nerve fiber

degeneration in females. The NOEL for

non-neoplastic changes was 150 ppm

(6.1 mg/kg/day for males and 8.4 mg/kg/

day for females) and an LEL of 300 ppm

(12.4 mg/kg/day for males and 16.5 mg/

kg/day for females).

6. An 18-month oncogenicity study in

mice using dosage levels of 200, 500 and

1,250 ppm (28.6, 71.4 and 178.6 mg/kg/

day, which showed no carcinogenicity.

7. A repeated mouse feeding study of

99 weeks at dose levels of 0, 160, 800,

and 4,000 ppm in which there was a

significantly increased incidence of

single and multiple areas of enlarged

eosinophilic hepatocytes and focal fatcontaining hepatocytes in both males

and females. In males there was an

increased incidence of generalized

vacuolation/hypertrophy of the

interstitial cells of the testes in the midand high-dose mice. There was a doserelated increase in female mice

displaying luteinization of the

interstitial cell of the ovary, but

statistical significance was not attained

at any dose level. The NOEL for nonneoplastic changes was 160 ppm (23

mg/kg/day for males and 27 mg/kg/day

for females) and the LEL was 800 ppm

(115 mg/kg/day for males and 138 mg/

kg/day for females).

8. A 1-year dog feeding study using

dosage levels of 100, 600 and 3,600 ppm

(4.2, 15, and 90 mg/kg/day) with a

NOEL of 100 ppm (4.2 mg/kg/day) and

an LEL of 600 ppm (15 mg/kg/day)

based on decreased prostate weight and

an increased number of erythrocytes

with Heinz bodies in males.

9. Another 1-year dog feeding study at

dosage levels of 200, 300, 400 and 600

ppm in which the NOEL was set at 400

ppm (17.5 mg/kg for males and 18.4 mg/

kg for females and an LEL set at 600

ppm (24.6 mg/kg for males and 26.4 mg/

kg for females) based on depressed red

blood cell parameters.

10. A 90-day feeding study in dogs

using dosage levels of 800, 2,400 and

7,200 ppm (20, 60, and 180 mg/kg/day)

with a NOEL of 2,400 ppm (60 mg/kg/

day) and an LEL of 7,200 ppm (180 mg/

kg/day) based on liver hypertrophy and

increased SAP.

11. Iprodione was tested in several

mutagenicity studies. The chemical was

negative in the Ames assay; CHO/

HGPRT mammalian cell forward

mutation assay, with and without

metabolic activation; in vitro

chromosome aberration assay in CHO

cells; in vitro sister chromatid exchange

assay in CHO cells; and dominant lethal

test in mice. Iprodione was positive in

the Bacillus subtilis assay for DNA

damage without metabolic activation.

The Reference Dose (RfD) of 0.06 mg/

kg/day based on a NOEL of 6.1 mg/kg/

day and an uncertainty factor of 100 was

used in the chronic risk analysis for

iprodione. Using percent crop treated

data and the Anticipated Residue

Contribution (ARC), the Theoretical

Maximum Residue Contribution

(TMRC) for the overall U.S. population

is 0.015134 mg/kg/day and utilizes 25%

of the RfD. For the most highly exposed

subgroup, non-nursing infants, the

TMRC is 0.045389 mg/kg/day and

utilizes 76% of the RfD. The calculated

percentage of the RfD is within a safe

margin and the chronic dietary risk

posed from iprodione is not of concern.

In analyzing for the acute dietary risk

tolerance level, residues were used to

calculate the exposure of the highest

exposed individual for the females (13

years old or older) which was compared

to the developmental NOEL of 60 mg/

kg/day from the rabbit study to

determine the Margin of Exposure

(MOE). The MOE was calculated to be

333. The Agency is not generally

concerned with acute risk unless the

MOE is below 100 when the NOEL is

taken from an animal study.

The Health Effects Division (HED)

Cancer Peer Review Committee

determined that iprodione should be

classified as a group B2 carcinogen

(probable human carcinogen).

Calculations of Q1* from the rat study

used in the risk analysis was based

upon interstitial cell benign tumor rates

and was calculated to be 0.0439 (mg/kg/

day)-1. In the dietary cancer risk

assessment, the upper bound cancer risk

was calculated for all registered

commodities when using anticipated

residues to be 6.0 × 10-6. This upper

bound cancer risk estimate exceeds the

Agency’s generally accepted level of

concern for dietary risk, even when

anticipated residues are used and

adjustments for percent crop treated are

made. In an agreement between the

Agency and Rhone-Poulenc Ag Co.,

various changes in the use pattern of

iprodione will be made to reduce the

residues of iprodione in or on several

crops. Although data are not available to

quantitatively determine the amount of

reduction, the overall quantity of

iprodione used will be reduced enough

to significantly affect the amount of

residues. This reduction is expected to

lower the upper bound cancer risk

estimate to an acceptable level.

The upper bound cancer risk

attributed to the use of iprodione on

cotton was calculated to be 1.8 × 10-8.

Therefore, the added use would be

unlikely to significantly affect the

overall cancer risk estimate. The

tolerance being established for

cottonseed is time-limited and the time

limitation is being imposed on the

condition that sufficient data are

submitted within the time period to

demonstrate that the risk has been

reduced to an acceptable level through

the changes in the use pattern of

iprodione containing products.

An adequate analytical method, gas

liquid chromatography using an

electron-capture detector, is available in

the Pesticide Analytical Manual, Vol. II,

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
Federal Register / Vol. 61, No. 87 / Friday, May 3, 1996 / Rules and Regulations 19847

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).

EPA has established a record for this

rulemaking under docket number [PP

2F4111/R2226] (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.

Electronic comments may 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 rulemaking 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. 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 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. Section 180.399, is amended by

adding paragraph (d) to read as follows:

§ 180.399 Iprodione; tolerances for

residues.

* * * * *

(d)(1) A time-limited tolerance, to

expire March 15, 1997, is established

permitting 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 following raw agricultural

commodity:

Commodity Parts per

million

Cottonseed ................................ 0.10

(2) Residues in this commodity not in

excess of the established tolerance

resulting from the use described in this

paragraph remaining after expiration of

the time-limited tolerance will not be

considered to be actionable if the

fungicide is applied during the term of

and in accordance with the provisions

of the above regulation.

[FR Doc. 96–10921 Filed 5–2–96; 8:45 am]

BILLING CODE 6560–50–F

40 CFR Part 180

[OPP–300403A; FRL–4995–8]

RIN 2070–AB78

Tebuthiuron; Pesticide Tolerances

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Final Rule.

SUMMARY: This final regulation

establishes lower tolerances for residues

of Tebuthiuron on grass hay and grass

rangeland forage and changes the

commodity name grass, rangeland

forage to grass, forage. These changes

are based on the Reregistration

Eligibility Decision tolerance

assessment for Tebuthiuron.

EFFECTIVE DATE: This regulation

becomes effective July 2, 1996.

ADDRESSES: Written objections and

hearing requests, identified by the

document control number, [OPP–

300403A], 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,