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
12708 Federal Register / Vol. 60, No. 45 / Wednesday, March 8, 1995 / Rules and Regulations

additional data are necessary to more

completely define the mechanism of

clofentezine’s thyroid tumor induction

in terms of the criteria listed in the

above document. Based on the rat

feeding/ carcinogenicity study, the

Agency has classified clofentezine as a

possible human carcinogen (Group C).

The qualitative designation ‘‘C’’ refer to

EPA’s weight-of-evidence classification.

The classification is based on the

Agency’s ‘‘Guidelines for Carcinogenic

Risk Assessment,’’ published in the

Federal Register of September 25, 1996

(51 FR 33992). The Agency believes a

quantitative risk assessment based on

the thyroid incidence is not approprate

for the following reasons:

1. The increase tumor incidence was

marginally increased above the control

incidence only at the highest dose tested

(20 mg/kg/day) in the chronic feeding

study.

2. The increased incidence was

observed only in male rats.

3. The thyroid tumor incidence in the

chronic feeding study’s highest dose

group (20 percent) was slightly greater

than the historical range provided by

limited control group data (7.5 to 15

percent) from two other studies.

4. 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.

5. The mouse was negative for

carcinogency effects at all dose levels,

i.e., 50, 500, 5,000 ppm (equivalent to

7.5, 75, 750 mg/kg/day, respectively).

6. There are no close structural

analogs with carcinogenic concerns

identified.

7. Clofentezine is not mutagenic in

several acceptable studies.

The Federal Insecticide, Fungicide,

and Rodenticide Act (FIFRA) Science

Advisory Panel (SAP) also reviewed the

weight-of-evidence consideration and

classification of the carcinogenic

potential of clofentezine. The SAP

review included the additional thyroid

studies submitted by Nor-Am that were

available at that time. The SAP

concluded that thyroid tumors in male

rats from the chronic feeding/

carcinogenicity study with clofentezine

did not provide adequate evidence of a

potential carcinogenic hazard to

humans and that the carcinogenic

potential of clofentezine belongs to

Group D (not classifiable as a human

carcinogen).

The Panel’s interpretation was based

on observed increases in thyroid

stimulation hormone (TSH) levels and

the incidence of thyroid follicular cell

hyperplasia which may be responses to

decreases in blood levels of the

circulating thyroid hormones

(triiodothyroxine (T3) and tetraiodothyroxine (T4) observed in

clofentezine-treated rats. This sequence

of reduced circulating thyroid hormones

and increased TSH levels and follicular

cell hyperplasia is known to lead to

thyroid tumors in rats, and the Panel

noted, ‘‘Exposure to agents that cause

this sequence in rats has not resulted in

increased TSH, hyperplasia, and thyroid

tumors in humans.’’ Therefore, the

Panel concluded that there was

inadequate data for suggesting human

carcinogenicity or a quantitative risk

assessment.

Nor-Am has since submitted

additional thyroid studies intended to

show the mechanism of clofentezine’s

thyroid tumor induction. The Agency

has reviewed these data, but as

previously stated, the Agency continues

to believe that additional data are

needed to more completely define the

mechanism of clofentezine’s thyroid

tumor induction and that the available

data are not sufficient to change the

classification of clofentezine from

Category ‘‘C’’ to Category ‘‘D.’’ However,

the Agency does agree with the SAP that

a quantitative risk assessment is not

appropriate.

The reference dose (RfD), based on the

1-year dog feeding/carcinogenic study

with a NOEL of 1.25 mg/kg/bwt and

100-fold uncertainity factor, is

calculated to be 0.013 mg/kg/bwt. The

theoretical maximum residue

contribution (TMRC) from published

uses is 0.000591 mg/kg/bwt/day. This

represents 4.54 percent of the RfD. The

proposed tolerance contributes .000231

mg/kg/bwt/day. This represents 1.78

precent of the RfD. Dietary exposure

from the existing uses and proposed

uses 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 residue is

understood. An adequate analytical

method, high-performance liquid

chromatography (HPLC), is available for

enforcement.

Also, in an editorial amendment to

the clofentezine tolerances in 40 CFR

180.446, EPA is removing the sole entry

in paragraph (a), for pears, and moving

it to the table in paragraph (b).

Paragraph (a) is redundant and is being

removed and designated as ‘‘reserved.’’

There are currently no actions

pending against the continued

registration of this chemical.

This pesticide is considered useful for

the purposes for which the tolerances

are 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 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
Federal Register / Vol. 60, No. 45 / Wednesday, March 8, 1995 / Rules and Regulations 12709

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 22, 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 § 180.446, by removing

paragraph (a) and designating it as

‘‘reserved’’ and by amending paragraph

(b) by revising the table therein, to read

as follows:

§ 180.446 Clofentezine; tolerances for

residues.

(a) [Reserved]

(b) * * *

Commodity Parts per

million

Almonds, hulls .......................... 5.0

Almonds, nutmeat ..................... 0.5

Apples ....................................... 0.01

Apricots ..................................... 1.0

Cherries .................................... 1.0

Nectarines ................................. 1.0

Peaches .................................... 1.0

Pears ......................................... 0.5

Walnuts ..................................... 0.02

* * * *

*

[FR Doc. 95–5651 Filed 3–7–95; 8:45 am]

BILLING CODE 6560–50–F

40 CFR Part 281

[FRL–5168–1]

Utah; Final Approval of State

Underground Storage Tank Program

AGENCY: Environmental Protection

Agency.

ACTION: Notice of final determination on

State of Utah application for final

approval.

SUMMARY: The State of Utah has applied

for final approval of its underground

storage tank program under Subtitle I of

the Resource Conservation and

Recovery Act (RCRA). The

Environmental Protection Agency (EPA)

has reviewed the Utah application and

has reached a final determination that

Utah’s underground storage tank (UST)

program satisfies all of the requirements

necessary to qualify for final approval.

Thus, EPA is granting final approval to

the State to operate its program in lieu

of the Federal program.

EFFECTIVE DATE: Final approval for Utah

shall be effective at 1:00 pm Eastern

Time on April 7, 1995.

FOR FURTHER INFORMATION CONTACT:

Leslie Zawacki, Underground Storage

Tank Program Section, U.S. EPA, Region

8, 8HWM–WM, 999 18th Street, Denver,

Colorado 80202, phone: (303) 293–1665.

SUPPLEMENTARY INFORMATION:

A. Background

Section 9004 of the Resource

Conservation and Recovery Act (RCRA)

enables EPA to approve state

underground storage tank programs to

operate in the State in lieu of the

Federal underground storage tank (UST)

program. Program approval is granted

by EPA if the Agency finds that the

State program: (1) is ‘‘no less stringent’’

than the Federal program in all seven

elements, and includes notification

requirements of section 9004(a)(8), 42

U.S.C. 6991c(a)(8); and (2) provides for

adequate enforcement of compliance

with UST standards (section 9004(a), 42

U.S.C. 6991c(a)).

On September 20, 1993, Utah

submitted an application for ‘‘complete’’

program approval which includes

regulation of both petroleum and

hazardous substance tanks. The State of

Utah established authority through the

Utah Solid and Hazardous Waste Act to

implement an underground storage tank

program in February 1986, and further

developed its authority in the UST Act

in February 1989. The State adopted the

federal rules and developed some

additional rules in February 1989.

On October 27, 1994, EPA published

a tentative decision announcing its

intent to grant Utah final approval.

Further background on the tentative

decision to grant approval appears at 59

FR 53955, October 27, 1994. Along with

the tentative determination, EPA

announced the availability of the

application for public comment and

provided notice that a public hearing

would be provided if significant public

interest was shown. EPA received no

comments on the application and no

request for a public hearing, therefore, a

hearing was not held.

B. Decision

I conclude that Utah’s application for

final approval meets all of the statutory

and regulatory requirements established

by Subtitle I of RCRA. Accordingly,

Utah is granted final approval to operate

its underground storage tank program in

lieu of the Federal program. Utah now

has the responsibility for managing

underground storage tank facilities

within its borders and carrying out all

aspects of the UST program except with

regard to ‘‘Indian Country,’’ as defined

in 18 U.S.C. 1151, where EPA will

retain and otherwise exercise regulatory

authority. Utah also has primary

enforcement responsibility, although

EPA retains the right to conduct

inspections under section 9005 of RCRA

42 U.S.C. 6991d and to take

enforcement actions under section 9006

of RCRA 42 U.S.C. 6991e.

Compliance With Executive Order

12866

The Office of Management and Budget

has exempted this rule from the

requirements of Section 6 of Executive

Order 12866.

Certification Under the Regulatory

Flexibility Act

Pursuant to the provisions of 5 U.S.C.

605(b), I hereby certify that this

approval will not have a significant

economic impact on a substantial

number of small entities. The approval

effectively suspends the applicability of

certain Federal regulations in favor of

Utah’s program, thereby eliminating

duplicative requirements for owners

and operators of underground storage

tanks in the State. It does not impose

any new burdens on small entities. This

rule, therefore, does not require a

regulatory flexibility analysis.