Federal Register / Vol. 60, No. 45 / Wednesday, March 8, 1995 / Rules and Regulations 12705

effects under conditions of the study

and that had a NOEL of 1,000 ppm (208

mg/kg/day).

There is no cancer risk associated

with exposure to this chemical.

Imidacloprid has been classified under

‘‘Group E’’ (no evidence of

carcinogenicity) by EPA’s OPP/HED’s

Reference Dose (RFD) Committee.

The reference dose (RfD), based on the

2-year rat feeding/carcinogenic study

with a NOEL of 5.7 mg/kg/bwt and 100-

fold uncertainty factor, is calculated to

be 0.057 mg/kg/bwt. The theoretical

maximum residue contribution (TMRC)

from published uses is 0.000985 mg/kg/

bwt/day. This represents 2% of the RfD.

The proposed tolerance contributes

0.000001 mg/kg/bwt/day. This

represents no significant increase in the

RfD. Dietary exposure from the existing

uses and proposed use will not exceed

the reference dose for any

subpopulation (including infants and

children) based on the information

available from EPA’s Dietary Risk

Evaluation System.

The nature of the imidacloprid

residue in plants and livestock is

adequately understood. The residues of

concern are combined residues of

imidacloprid and it metabolites

containing the 6-chloropyridinyl

moiety, all calculated as imidacloprid.

The analytical method is a common

moiety method for imidacloprid and its

metabolites containing the 6-

chloropyridinyl moiety using a

permanganate oxidation, silyl

derivatization, and capillary GC–MS

selective ion monitoring. Imidacloprid

and its metabolites are stable in the

commodities when frozen for at least 24

months. There are adequate amounts of

geographically representative crop field

trial data to show that combined

residues of imidacloprid and its

metabolites, all calculated as

imidacloprid, will not exceed the

proposed tolerance on mangoes at 0.2

ppm when use as directed.

There are currently no actions

pending against the continued

registration of this chemical.

This pesticide is considered useful for

the purposes for which the tolerance is

sought and capable of achieving the

intended physical or technical effect.

Based on the information and data

considered, the Agency has determined

that the tolerances 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 a genuine and substantial issue

of fact; there is a reasonable possibility

that available evidence identified by the

requestor would, if established, resolve

one or more of such issues in favor of

the requestor, taking into account

uncontested claims or facts to the

contrary; and resolution of the factual

issue(s) in the manner sought by the

requestor would be adequate to justify

the action requested (40 CFR 178.32).

Under Executive Order 12866 (58 FR

51735, October 4, 1993), the Agency

must determine whether the regulatory

action is ‘‘significant’’ and therefore

subject to 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: February 21, 1995.

Stephen L. Johnson,

Director, Registration Division, Office of

Pesticide Programs.

Therefore, 40 CFR part 180 is

amended as follows:

PART 180—[AMENDED]

1. The authority citation for part 180

continues to read as follows:

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

2. In § 180.472, by amending

paragraph (a) in the table therein by

adding and alphabetically inserting the

entry for mango, to read as follows:

§ 180.472 1-[(6-Chloro-3-pyridinyl)methyl]-

N-nitro-2-imidazolidinimine; tolerances for

residues.

(a) * * *

Commodity Part per

million

* * * * *

Mango ....................................... 0.2

* * * * *

* * * *

*

[FR Doc. 95–5653 Filed 3–7–95; 8:45 am]

BILLING CODE 6560–50–F

40 CFR Part 180

[OPP–300374A; FRL–4933–7]

RIN 2070–AB78

3,5-Bis(6-Isocyanatohexyl)-2H-1,3,5-

Oxadiazine-2,4,6-(3H,5H)-Trione,

Polymer With Diethylenetriamine;

Tolerance Exemption

AGENCY: Environmental Protection

Agency (EPA).
12706 Federal Register / Vol. 60, No. 45 / Wednesday, March 8, 1995 / Rules and Regulations

ACTION: Final rule.

SUMMARY: This document establishes an

exemption from the requirement of a

tolerance for residues of 3,5-bis(6-

isocyanatohexyl)-2H-1,3,5-oxadiazine2,4,6-(3H,5H)-trione, polymer with

diethylenetriamine (CAS Reg. No.

87823-33-4), when used as an inert

ingredient (encapsulating agent) in

pesticide formulations applied to

growing crops. Miles, Inc., requested

this regulation.

EFFECTIVE DATE: This regulation

becomes effective March 8, 1995.

ADDRESSES: Written objections,

identified by the document control

number, [OPP-300374A], 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 request

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

Davis Hwy., Arlington, VA 22202. Fees

accompanying objections shall be

labeled ‘‘Tolerance Petition Fees’’ and

forwarded to: EPA Headquarters

Accounting Operations Branch, OPP

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

Pittsburgh, PA 15251.

FOR FURTHER INFORMATION CONTACT: By

mail: Connie Welch, Registration

Support Branch, Registration Division

(7508W), Office of Pesticide Programs,

Environmental Protection Agency, 401

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

Office location and telephone number:

Westfield Building North, 6th Fl., 2800

Crystal Drive, Arlington, VA 22202,

(703)–308–8470.

SUPPLEMENTARY INFORMATION: In the

Federal Register of January 12, 1995 (60

FR 2921), EPA issued a proposed rule

that gave notice that Miles, Inc., 8400

Hawthorn Rd., P.O. Box 4913, Kansas

City, MO 64120–0013, had submitted

pesticide petition (PP) 4E4416 to EPA

requesting that the Administrator,

pursuant to section 408(e) of the Federal

Food, Drug, and Cosmetic Act (FFDCA)

(21 U.S.C. 346a(e)), propose to amend

40 CFR 180.1001(d) by establishing an

exemption from the requirement of a

tolerance for residues of 3,5-bis(6-

isocyanatohexyl)-2H-1,3,5-oxadiazine2,4,6-(3H,5H)-trione, polymer with

diethylenetriamine (CAS Reg. No.

87823-33-4), when used as an inert

ingredient (encapsulating agent) in

growing crops under 40 CFR

180.1001(d).

Inert ingredients are all ingredients

that are not active ingredients as defined

in 40 CFR 153.125, and include, but are

not limited to, the following types of

ingredients (except when they have a

pesticidal efficacy of their own):

solvents such as alcohols and

hydrocarbons; surfactants such as

polyoxyethylene polymers and fatty

acids; carriers such as clay and

diatomaceous earth; thickeners such as

carrageenan and modified cellulose;

wetting, spreading, and dispersing

agents; propellants in aerosol

dispensers; microencapsulating agents;

and emulsifiers. The term ‘‘inert’’ is not

intended to imply nontoxicity; the

ingredient may or may not be

chemically active.

There were no comments or requests

for referral to an advisory committee

received in response to the proposed

rule.

The data submitted relevant to the

proposal and other relevant material

have been evaluated and discussed in

the proposed rule. Based on the data

and information considered, the Agency

concludes that the tolerance exemption

will protect the public health.

Therefore, the tolerance exemption 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

and/or request a hearing 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 a genuine and substantial issue

of fact; there is a reasonable possibility

that available evidence identified by the

requestor would, if established, resolve

one or more of such issues in favor of

the requestor, taking into account

uncontested claims or facts to the

contrary; and resolution of the factual

issue(s) in the manner sought by the

requestor would be adequate to justify

the action requested (40 CFR 178.32).

Under Executive Order 12866 (58 FR

51735, Oct. 4, 1993), the Agency must

determine whether the regulatory action

is ‘‘significant’’ and therefore subject to

review by the Office of Management and

Budget (OMB) and the requirements of

the Executive Order. Under section 3(f),

the order defines a ‘‘significant

regulatory action’’ as an action that is

likely to result in a rule (1) having an

annual effect on the economy of $100

million or more, or adversely and

materially affecting a sector of the

economy, productivity, competition,

jobs, the environment, public health or

safety, or State, local, or tribal

governments or communities (also

referred to as ‘‘economically

significant’’); (2) creating serious

inconsistency or otherwise interfering

with an action taken or planned by

another agency; (3) materially altering

the budgetary impacts of entitlement,

grants, user fees, or loan programs or the

rights and obligations or recipients

thereof; or (4) raising novel legal or

policy issues arising out of legal

mandates, the President’s priorities, or

the principles set forth in this Executive

Order.

Pursuant to the terms of the Executive

Order, EPA has determined that this

rule is not ‘‘significant’’ and is therefore

not subject to OMB review.

Pursuant to the requirements of the

Regulatory Flexibility Act (Pub. L. 96–

354, 94 Stat. 1164, 5 U.S.C. 601–612),

the Administrator has determined that

regulations establishing new tolerances

or raising tolerance levels or

establishing exemptions from tolerance

requirements do not have a significant

economic impact on a substantial

number of small entities. A certification

statement to this effect was published in

the Federal Register of May 4, 1981 (46

FR 24950).

List of Subjects in 40 CFR Part 180

Environmental protection,

Administrative practice and procedure,

Agricultural commodities, Pesticides

and pests, Reporting and recordkeeping

requirements.

Dated: February 24, 1995.

Stephen L. Johnson,

Director, Registration Division, Office of

Pesticide Programs.

Therefore, 40 CFR part 180 is

amended as follows:

PART 180—[AMENDED]

1. The authority citation for part 180

continues to read as follows:
Federal Register / Vol. 60, No. 45 / Wednesday, March 8, 1995 / Rules and Regulations 12707

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

2. Section 180.1001(d) is amended in

the table therein by adding and

alphabetically inserting the inert

ingredient, to read as follows:

§ 180.1001 Exemptions from the

requirement of a tolerance.

* * * *

*

(d) * * *

Inert ingredients Limits Uses

* * * * * * *

3,5-Bis(6-isocyanatohexyl)-2H-1,3,5-oxadiazine-2,4,6-

(3H,5H)-trione, polymer with diethylenetriamine

(CAS Reg. No. 87823-33-4); minimum number average molecular weight 1,000,000..

.............................................. Encapsulating agent

* * * * * * *

* * * * *

[FR Doc. 95–5652 Filed 3–7–95; 8:45 am]

BILLING CODE 6560–50–F

40 CFR Part 180

[PP 6F3392/R2105; FRL–4933–1]

RIN 2070–AB78

Pesticide Tolerance for Clofentezine

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Final rule.

SUMMARY: This rule establishes a

tolerance for residues of the insecticide

clofentezine in or on the raw

agricultural commodity apples. AgroEvo

USA Corp. (formerly Nor-Am Chemical

Co.) requested this regulation to

establish a maximum permissible level

for residues of the insecticide.

EFFECTIVE DATE: This regulation is

effective February 22, 1995.

ADDRESSES: Written objections and

hearing requests, identified by the

document control number, [PP 6F3392/

R2105], 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.

FOR FURTHER INFORMATION CONTACT: By

mail: Dennis H. Edwards, Product

Manager (PM) 19, Registration Division

(7505C), Office of Pesticide Programs,

Environmental Protection Agency, 401

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

Office location and telephone number:

Rm. 207, CM #2, 1921 Jefferson Davis

Hwy., Arlington, VA 22202. (703)–305–

3686.

SUPPLEMENTARY INFORMATION: EPA

issued a notice, published in the

Federal Register of June 4, 1986 (51 FR

20343), which announce that Nor-Am

Chemical Co. of Little Falls Centre One,

2711 Centerville Rd., Wilmington, DE

19803, had sumitted a pesticide petition

to EPA requesting that the

Administrator, pursuant to section

408(d) of the Federal Food, Drug and

Costmetic Act (FFDCA), 21 U.S.C.

346a(d), propose to amend 40 CFR

180.446 by establishing tolerances for

residues of the insecticide clofentezine

3,b-bis(2-chlorophenyl)-1,2,4,5-tetrazine

in or on the commodities apples at 0.05

part per million (ppm), meat at 0.05

ppm, meat byproducts at 0.05 ppm,

milk at 0.01 ppm, and poultry and

poultry byproducts at 0.05. A feed

additive tolerance was proposed for dry

apple pomace at 1.0 ppm.

Subsequent to the orginal notice of

filing, EPA issued a notice, published

Federal Register of May 27, 1992 (57 FR

22232), which announced that the NorAm Chemical Co. was amending

pesticide petition 6F3392 by increasing

the proposed tolerance in/on apples to

0.01 ppm, withdrawing the proposed

feed additive tolerance, and

withdrawing the petition for animal

tolerances since they have already been

established.

There were no comments or requests

for referral to an advisory committee

received in response to the notice of

filings.

The scientific data submitted in the

petition and other relevant material

have been evaluated. The toxicological

data considered in support of the

tolerance include a 1-year dog feeding

study with a no-observed-effect level

(NOEL) of 50 ppm (1.25 mg/kg/day); a

mouse carcinogenicity study which was

negative at the doses tested, 50 ppm (7.5

mg/kg/day), 500 ppm (75 mg/kg/day),

and 5,000 ppm (750 mg/kg/day); a

multi-generation rat study with a NOEL

of 400 ppm (20 mg/kg/day) (highest

dose tested (HDT); a rat teratology study

which was negative at 3,200 mg/kg/day

(HDT) and had a developmental NOEL

of 3,200 mg/kg/day; a rabbit teratology

study which was negative at 3,000 mg/

kg/day (HDT) also had a NOEL of 1,000

mg/kg/day for maternal toxicity

(reduced litter and fetal body weights);

and a 2-year rat chronic feeding/

carcinogenicity study which showed an

increase in the incidence of

centrilobular hepatocyte hypertrophy

and showed a statistically significant

increase in thyroid follicular cell tumors

in male rats at 400 ppm (20 mg/kg/day

(HDT). Gene mutation, chromosomal

aberrations, and diet DNA damage tests

were negative for genetic toxicity.

The registrant (Nor-AM) also

submitted additional thyroid studies

intended to show that there was an

indirect mechanism for the follicular

cell tumors associated with

clofentezine’s liver toxicity. The Agency

has reviewed the data in accordance

with criteria outlined in a draft

document entitled, ‘‘Thyroid Follicular

Cell Carcinogenesis: Mechanistic and

Science Policy Considerations,’’

(December 15, 1987). While this

document is still undergoing Agency

review, and the assessment procedures

set forth therein have not been adopted

by the Agency, the draft does provide a

useful framework in which to consider

the issue. Although the additional

thyroid function studies suggest the

possibility of an indirect mechanism for

follicular cell tumor induction that may

be associated with clofentezine’s liver

toxicity, the Agency believes that