19852 Federal Register / Vol. 61, No. 87 / Friday, May 3, 1996 / Rules and Regulations

or, if the waiver has been denied, the

proper fee is submitted after notice of

denial. A request for waiver or refund

will not be accepted after scientific

review has begun on a petition.

(o) This fee schedule will be changed

annually by the same percentage as the

percent change in the Federal General

Schedule (GS) pay scale. In addition,

processing costs and fees will

periodically be reviewed and changes

will be made to the schedule as

necessary. When automatic adjustments

are made based on the GS pay scale, the

new fee schedule will be published in

the Federal Register as a Final Rule to

become effective 30 days or more after

publication, as specified in the rule.

When changes are made based on

periodic reviews, the changes will be

subject to public comment.

[FR Doc. 96–10918 Filed 5–2–96; 8:45 am]

BILLING CODE 6560–50–F

40 CFR Part 180

[PP 4F4406/R2222; FRL–5358–5]

RIN 2070–AB78

Tefluthrin; Renewal of Time-limited

Tolerances

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Final rule.

SUMMARY: This rule establishes a

tolerance for the combined residues of

the pyrethroid tefluthrin and its

metabolites in or on the raw agricultural

commodity (RAC) corn, fresh (including

sweet K + CWHR) at 0.06 parts per

million (ppm), and corn, forage and

fodder, sweet at 0.06 ppm and renews

time-limited tolerances for tefluthrin on

the RAC’s corn, grain, field, and pop;

corn forage and fodder, field and pop.

These regulations to establish maximum

permissible levels for residues of the

chemical and renew tolerances were

requested in a petition submitted by

Zeneca Ag Products.

EFFECTIVE DATE: This regulation

becomes effective May 3, 1996.

ADDRESSES: Written objections and

hearing requests, identified by the

document control number, [PP 4F4406/

R2222], may be submitted to: Hearing

Clerk (A–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 4F4406/R2222] . 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 T. 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. 200, CM#2, 1921 Jefferson Davis

Highway, Arlington, VA 22202 (703)

305-6100; e-mail:

larocca.george@epamail.epa.gov.

SUPPLEMENTARY INFORMATION: EPA

issued a notice published in the Federal

Register of February 8, 1995 (60 FR

7540)(FRL-4926-4), which announced

that Zeneca Ag Products had submitted

pesticide petition (PP) 4F4406 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

insecticide tefluthrin (2,3,5,6-tetrafluro4-methylphenyl)methyl-(1 alpha, 3

alpha)-(Z)-( ±)-3(2-chloro-3,3,3-trifluoro1-propenyl)-2,2-

dimethylcyclopropanecarboxylate) and

its metabolite (Z)-3-(2-chloro-3,3,3-

trifluroro-1-propenyl)-2,2-

dimethylcyclopropanecarboxylic acid,

in or on the raw agricultural commodity

corn, fresh (including sweet K + CWHR)

at 0.06 ppm, and corn, forage and

fodder, sweet at 0.06 parts per million

(ppm).

No comments were received in

response to the notice of filing.

The scientific data submitted in the

petition and other relevant material

have been evaluated. The toxicological

and metabolism data considered in

support of the tolerance are discussed in

detail in related documents published

in the Federal Register of February 1,

1989 (54 FR 5080).

A dietary exposure/risk assessment

was performed for teflutrhin on sweet

corn using a Reference Dose (RfD) of

0.005 mg/kg/day, based on a noobserved-effect-level (NOEL) of 0.5 mg/

kg bwt/day from a 1– year dog feeding

study with an uncertainty factor of 100.

The endpoint of concern was increased

incidence of ataxia. The Theoretical

Maximum Residue Contribution

(TMRC) from established tolerances

utilizes 0.41% of the RfD for the U. S.

population or 0.69% of the RfD if the

new tolerance is granted. Established

tolerances utilize 1.06% of the RfD for

nonnursing infants less than 1 year old,

the subgroup with the highest estimated

exposure to tefluthrin residues or 1.71%

of the RfD if the new tolerance is

granted.

Generally speaking, EPA has no cause

for concern if total residue contribution

for published and final tolerances is less

than the RfD.

The nature of tefluthrin residue in

plants and animals for this corn use is

adequately understood. The residues of

concern is tefluthrin and its metabolite.

There is no reasonable expectation of

secondary residues in animal tissues

and milk from the use as delineated in

40 CFR 180.6(a)(3). An adequate

analytical method, gas liquid

chromatography with an electron

capture detector, is available for

enforcement purposes. The enforcement

methodology has been submitted to the

Food and Drug Administration, and is

published in the Pesticide Analytical

Manual Vol. II (PAM II).

In the Federal Register of September

30, 1994 (59 FR 49824) EPA amended

40 CFR 180.440 by extending to

November 15, 1995 tolerances of 0.06

ppm for residues of tefluthrin in or on

field and pop, corn grain including,

forage and fodder. The tolerances were

extedned to coincide with the extension

of the conditional registration of this

pesticide to allow time for EPA to

review data and complete an aquatic

risk assessment for use on field and pop

corn. The basis for the extension is

discussed in detail in the above Federal

Register notice. On November 14, 1995

EPA again amended the conditional
Federal Register / Vol. 61, No. 87 / Friday, May 3, 1996 / Rules and Regulations 19853

registration of this pesticide on field and

pop corn by extending the expiration

date to November 15, 1996. The

registration was amended and extended

for an additional year to allow time for

submission and evaluation of additional

data/information on aquatic risk

mitigation, specifically, surface-water

runoff data. Zeneca Ag Products

submitted this information on December

1, 1995.

To be consistent with the extension

issued for the conditional registration

the Agency is renewing the tolerances

on field and pop corn grains, including

their forage and fodder, with an

expiration date of November 15, 1997 to

cover residues expected to result from

use during the period of conditional

registration.

With respect to the additional use of

tefluthrin on sweet corn, the Agency

concluded that this additional use

would not cause a significant increase

in the risk of adverse effects to the

environment. This conclusion was

premised mainly on the following:

1. The directions for use and

precautions for use of tefluthrin on

sweet corn are identical to the current

directions for use for tefluthrin on field

and pop corn.

2. Current, interim aquatic risk

mitigation measures approved for use

on field and pop corn will also be used

for application on sweet corn.

To be consistent with the conditional

registration and renewal on field and

pop corn the Agency is issuing a

conditional registration with an

expiration date of November 15, 1996

and establishing a time-limited

tolerance on sweet corn and its forage

and fodder with an expiration date of

November 15, 1997 to cover residues

expected to result from use during the

period of conditioanl registration.

Upon evaluation of the additional

data/information required as a condition

of the registration for this insecticide on

corn the Agency will reassess the

tolerances and the registration, and if

appropriate, will issue permanent

tolerances and an unconditional

registration for the insecticide on corn.

Residues remaining in or on the above

commodities after expiration of these

tolerances will not be considered

actionable if the pesticide is legally

applied during the term of and in

accordance with the provisions of the

conditional registration.

There are presently no actions

pending against the continued

registration of this chemical.

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 4F4406/R2222] (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.

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 to this effect was published in

the Federal Register of May 4, 1981 (46

FR 24950).

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 (P.L. 104-4), or

require prior consultation as specified

by Executive Order 12875 (58 FR 58093,

October 28, 1993), entitled Enhancing

the Intergovenmental Partnership, or

special considerations as required by

Executive Order 12898 (59 FR 7629,

February 16, 1994).

List of Subjects in 40 CFR Part 180

Environmental protection,

Administrative practice and procedure,
19854 Federal Register / Vol. 61, No. 87 / Friday, May 3, 1996 / Rules and Regulations

Agricultural commodities, Pesticides

and pests, Reporting and recordkeeping

requirements.

Dated: April 4, 1996.

Susan Lewis,

Acting 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. By revising 180.440, and the table

therein to read as follows:

§ 180.440 Tefluthrin; tolerances for

residues.

Tolerances, to expire on November

15, 1997, are established for the

combined residues of the insecticide

tefluthrin (2,3,5,6-tetrafluro-4-

methylphenyl)methyl-(1-alpha, 3-

alpha)-(Z)-(±)-3(2-chloro-3,3,3-trifluoro1-propenyl)-2,2-

dimethylcyclopropanecarboxylate) and

its metabolite (Z)3-3-(2-chloro-3,3,3-

trifluro-1-propenyl)-2,2-

dimethylcyclopropanecarboxylic acid

raw agricultural commodities:

Commodity Parts per

million

Corn, grain, field and pop ......... 0.06

Corn, forage and fodder, field,

pop and sweet ....................... 0.06

Corn, fresh (including sweet K

and CWHR) ........................... 0.06

[FR Doc. 96–10917 Filed 5–2–96; 8:45 am]

BILLING CODE 6560–50–F

40 CFR Part 180

[OPP–300410A; FRL–5359–5]

Xanthan Gum-Modified, Produced by

the Reaction of Xanthan Gum and

Glyoxal; Tolerance Exemption

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Final rule.

SUMMARY: This document exempts

xanthan gum-modified, produced by the

reaction of xanthan gum and glyoxal

(maximum 0.3% by weight) from the

requirement of a tolerance when used as

a surfactant in pesticide formulations.

This regulation was requested by

Rhone-Poulenc, Inc., pursuant to the

Federal Food, Drug, and Cosmetic Act

(FFDCA).

EFFECTIVE DATE: This regulations

becomes effective on May 3, 1996.

ADDRESSES: Written objections and

hearing requests, identified by the

document control number, [OPP–

300410A], 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 [OPP–300410A]. No

Confidential Business Information (CBI)

should be submitted through e-mail.

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: Amelia M. Acierto, Registration

Support Branch, Registration Division

(7505W), Office of Pesticide Programs,

Environmental Protection Agency, 401

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

Office location, telephone number, and

e-mail address: 2800 Crystal Drive,

North Tower, Arlington, VA, (703)–308–

8375, e-mail:

acierto.amelia@epamail.epa.gov.

SUPPLEMENTARY INFORMATION: In the

Federal Register of February 7, 1996 (61

FR 4621) (FRL–4994–4), EPA issued a

pesticide petition (PP) 2E04084 from

Rhone-Poulenc, Inc., CN 7500,

Cranbury, NJ 08512–7500, requesting

that the Administrator, pursuant to

section 408(e) of the Federal Food, Drug,

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

propose to amend 40 CFR 180.1001(c)

by establishing an exemption from the

requirement of a tolerance for xanthan

gum, modified, produced by the

reaction of xanthan gum and glyoxal

(maximum 0.3% by weight) when used

as a surfactant in pesticide formulations

applied to growing crops or to raw

agricultural commodities after harvest.

There were no comments received in

response to the proposed rule.

Based upon a review of the data

submitted and a review of its use, EPA

has found that, when used in

accordance with good agricultural

practice, this ingredient is useful and a

tolerance is not necessary to protect the

public health. Therefore, EPA is

exempting xanthan gum-modified,

produced by the reaction of xanthum

gum and glyoxal (maximum 0.3% by

weight) from the requirement of a

tolerance 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).

EPA has established a record for this

rulemaking under docket number [OPP–

300410A] (including any comments and

data submitted electronically). A public