Federal Register / Vol. 66, No. 100 / Wednesday, May 23, 2001 / Rules and Regulations 28383

REFRIGERATION AND AIR CONDITIONING—Continued

End-Use Substitute Recommendation Comments

Industrial process refrigeration

(new).

HFC–134a/HBr (92/8) as a substitute for CFC–11, CFC–12,

CFC–114, CFC–115 and R–

502.

Acceptable .................................... Users are expected to adhere to

the 3 ppm Permissible Exposure Limit and Threshold Limit

Value set by OSHA and

ACGIH, respectively. Users are

expected to follow all recommendations specified in Material Safety Data Sheets for

HBr, HFC–134a and the blend.

Additional warning signs, worker education and technician

training is recommended to

minimize exposures.

Refrigerated transport (new) .......... HFC–134a/HBr (92/8) as a substitute for CFC–12 and R–502.Acceptable .................................... Users are expected to adhere to

the 3 ppm Permissible Exposure Limit and Threshold Limit

Value set by OSHA and

ACGIH, respectively. Users are

expected to follow all recommendations specified in Material Safety Data Sheets for

HBr, HFC–134a and the blend.

Additional warning signs, worker education and technician

training is recommended to

minimize exposures.

Very low temperature refrigeration

(retrofit and new).

PFC–330ST, PFC–550HC, PFC–

660HC, PFC–1100HC, PFC–

1100LT, PGC–100, PGC–150,

PFC–331ST, PFC–551HC,

PFC–661HC, PFC–1101HC

and PGC–151 assubstitutes for

CFC–13, CFC–113, CFC–114

and blends thereof.

Acceptable.

[FR Doc. 01–12893 Filed 5–22–01; 8:45 am]

BILLING CODE 6560–50–P

ENVIRONMENTAL PROTECTION

AGENCY

40 CFR Part 180

[OPP–301124; FRL–6781–7]

RIN 2070–AB78

Aspergillus flavus AF36; Extension of

Temporary Exemption From the

Requirement of a Tolerance

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Final rule.

SUMMARY: This regulation extends a

temporary exemption from the

requirement of a tolerance for residues

of the biological Aspergillus flavus

AF36, (A. flavus) a non-aflatoxin

producing strain of A. flavus, on cotton

when applied or used as aerial prebloom applications to cotton in

specified counties of Arizona. The

Interregional Research Project Number 4

(IR-4), New Jersey Agricultural

Experiment Station, Technology Center

of New Jersey, Rutgers University, 681

U.S. Highway #1 South, North

Brunswick, NJ 08902–3390, submitted

an amended petition to EPA under the

Federal Food, Drug, and Cosmetic Act,

as amended by the Food Quality

Protection Act of 1996 requesting the

temporary exemption. This regulation

eliminates the need to establish a

maximum permissible level for residues

of Aspergillus flavus AF36. The

temporary tolerance exemption will

expire on December 30, 2003.

DATES: This regulation is effective May

23, 2001. Objections and requests for

hearings, identified by docket control

number OPP–301124, must be received

by EPA on or before July 23, 2001.

ADDRESSES: Written objections and

hearing requests may be submitted by

mail, in person, or by courier. Please

follow the detailed instructions for each

method as provided in Unit III. of the

SUPPLEMENTARY INFORMATION. To ensure

proper receipt by EPA, your objections

and hearing requests must identify

docket control number OPP–301124 in

the subject line on the first page of your

response.

FOR FURTHER INFORMATION CONTACT: By

mail: Shanaz Bacchus, c/o Product

Manager (PM) 90, Biopesticides and

Pollution Prevention Division (7511C),

Environmental Protection Agency, 1200

Pennsylvania Ave., NW., Washington,

DC 20460; telephone number: 703-308-

8097; and e-mail address:

bacchus.shanaz@epa.gov.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

You may be affected by this action if

you are an agricultural producer, food

manufacturer, or pesticide

manufacturer. Potentially affected

categories and entities may include, but

are not limited to:

Categories NAICS Examples of Potentially Affected Entities

Industry 111 Crop production

112 Animal production

311 Food manufacturing

32532 Pesticide manufacturing

This listing is not intended to be

exhaustive, but rather provides a guide

for readers regarding entities likely to be

affected by this action. Other types of

28384 Federal Register / Vol. 66, No. 100 / Wednesday, May 23, 2001 / Rules and Regulations

entities not listed in the table could also

be affected. The North American

Industrial Classification System

(NAICS) codes have been provided to

assist you and others in determining

whether or not this action might apply

to certain entities. If you have questions

regarding the applicability of this action

to a particular entity, consult the person

listed under FOR FURTHER INFORMATION

CONTACT.

B. How Can I Get Additional

Information, Including Copies of this

Document and Other Related

Documents?

1. Electronically. You may obtain

electronic copies of this document, and

certain other related documents that

might be available electronically, from

the EPA Internet Home Page at http://

www.epa.gov/. To access this

document, on the Home Page select

‘‘Laws and Regulations,’’ ‘‘Regulations

and Proposed Rules,’’ and then look up

the entry for this document under the

‘‘Federal Register—Environmental

Documents.’’ You can also go directly to

the Federal Register listings at http://

www.epa.gov/fedrgstr/. A frequently

updated electronic version of 40 CFR

part 180 is available at http://

www.access.gpo.gov/nara/cfr/

cfrhtml_180/Title_40/40cfr180_00.html,

a beta site currently under development.

2. In person. The Agency has

established an official record for this

action under docket control number

OPP–301124. The official record

consists of the documents specifically

referenced in this action, and other

information related to this action,

including any information claimed as

Confidential Business Information (CBI).

This official record includes the

documents that are physically located in

the docket, as well as the documents

that are referenced in those documents.

The public version of the official record

does not include any information

claimed as CBI. The public version of

the official record, which includes

printed, paper versions of any electronic

comments submitted during an

applicable comment period is available

for inspection in the Public Information

and Records Integrity Branch (PIRIB),

Rm. 119, Crystal Mall #2, 1921 Jefferson

Davis Hwy., Arlington, VA, from 8:30

a.m. to 4 p.m., Monday through Friday,

excluding legal holidays. The PIRIB

telephone number is (703) 305–5805.

II. Background and Statutory Findings

In the Federal Register of May 26,

1999 (64 FR 28371) (FRL–6081–2), EPA

issued a final rule pursuant to section

408 of the Federal Food, Drug, and

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

as amended by the Food Quality

Protection Act of 1996 (FQPA) (Public

Law 104–170) establishing a temporary

exemption from the requirement of a

tolerance for residues of A. flavus AF36

on cotton grown in 5 counties in

Arizona (40 CFR 180.1206). This final

rule included a summary of the

Agency’s assessment of the health

effects data submitted in support of the

extension of the temporary tolerance

exemption. The temporary exemption

from tolerance was extended until

December 2001 (64 FR 35049, June 30,

1999) (FRL–6087–3) to allow for passage

of the treated commodities through the

channels of trade.

Comments submitted to the Agency

regarding the use of this competitive

fungal agent were by the cotton growers

in the region who were all in favor of

the extension of the exemption from the

temporary tolerance. Both the toxigenic

and atoxigenic strains are naturally

occurring in Arizona. The growers were

of the opinion that this technology is

likely to reduce the high levels of the

naturally occurring, toxin-producing

strain of A. flavus by displacement. No

adverse effects were reported in the

yearly annual reports of the

Experimental Use Permit, and in some

instances aflatoxin levels of cotton seed

were reduced in treated cotton.

New section 408(c)(2)(A)(i) of the

FFDCA allows EPA to establish an

exemption from the requirement for a

tolerance (the legal limit for a pesticide

chemical residue in or on a food) only

if EPA determines that the exemption is

‘‘safe.’’ Section 408(c)(2)(A)(ii) defines

‘‘safe’’ to mean that ‘‘there is a

reasonable certainty that no harm will

result from aggregate exposure to the

pesticide chemical residue, including

all anticipated dietary exposures and all

other exposures for which there is

reliable information.’’ This includes

exposure through drinking water and in

residential settings, but does not include

occupational exposure. Section

408(b)(2)(C) requires EPA to give special

consideration to exposure of infants and

children to the pesticide chemical

residue in establishing a tolerance and

to ‘‘ensure that there is a reasonable

certainty that no harm will result to

infants and children from aggregate

exposure to the pesticide chemical

residue....’’ Additionally, section

408(b)(2)(D) requires that the Agency

consider ‘‘available information

concerning the cumulative effects of a

particular pesticide’s residues and

‘‘other substances that have a common

mechanism of toxicity.’’

EPA performs a number of analyses to

determine the risks from aggregate

exposure to pesticide residues. First,

EPA determines the toxicity of

pesticides. Second, EPA examines

exposure to the pesticide through food,

drinking water, and through other

exposures that occur as a result of

pesticide use in residential settings.

The fungal agent is applied prebloom

to the soil of treated cotton fields. When

conditions are appropriate, the AF 36

spores land on the cotton plant and

germinate to displace the naturally

occurring toxigenic strain. No adverse

effects were reported in the annual

reports which the registrant submitted

as required in the EUP.

This extension of the exemption from

the requirement of a temporary

tolerance is associated with an

extension of an Experimental Use

Permit (EUP, EPA Reg. No. 69224–EUP–

1). This extension of the EUP will allow

aerial application of A. flavus AF36 in

the following counties of Arizona: Yuma

(3,300 acres), Maricopa (13,150 acres),

Mohave (1,700 acres) and Pinal (1,850

acres). This final rule extends the

temporary exemption from a tolerance

for residues of Aspergillus flavus AF36

on cotton until December 30, 2003.

Of the strains of A. flavus found

naturally in Arizona, this atoxigenic

strain comprises about 15% of the

natural microbial population in the soil,

as opposed to the predominant S or

toxigenic S strain.

Summaries of the toxicological profile

and other relevant manufacturing and

health effects data, to comply with the

guideline requirements of the Food

Quality Protection Act of 1996, were

reported in the Federal Register

publication of the final rule of May 26,

1999, extending the temporary tolerance

exemption. Based on the previously

submitted data outlined in the final

rule, there is a reasonable certainty that

no harm will result from aggregate

exposure to the U.S. population,

including infants and children, to A.

flavus AF36 from the limited use

pattern of this experimental use permit.

This includes all anticipated dietary

exposures and all other exposures for

which there is reliable information.

The Agency continues to require that

the pesticide must not be applied within

a boundary of 400 feet of residential

areas, schools, daycare and health care

facilities and hospitals to minimize

exposure to human adults, infants and

children.

Data have been submitted to

demonstrate that this strain excludes the

aflatoxin-producing strain when it is

applied prior to flowering. Thus, the

proposed use is not likely to result in

appreciable increases in the long-term

population of A. flavus on the crop

beyond naturally occurring levels.

Federal Register / Vol. 66, No. 100 / Wednesday, May 23, 2001 / Rules and Regulations 28385

Furthermore, there is no expectation of

cumulative effects with other pesticides,

because this is the only registered

experimental microbe in this genus.

As in the earlier EUP, the Agency

requires that applicators and other

handlers must wear gloves, a dust/mist

filtering respirator with NIOSH approval

prefix N–95, R–95 or P–95, long sleeved

shirt and long pants, and shoes plus

socks to mitigate potential worker

exposure.

The Food and Drug administration

(FDA) regulates the levels of aflatoxin in

cotton seed meal and other commodities

associated with the production of

cotton. Treated cotton and its by

products are screened for aflatoxin prior

to introduction into the channels of

commerce. FDA does not allow

cottonseed products containing

aflatoxin at 20 parts per billion (ppb) or

higher to be used in dairy rations. FDA

regulations also do not allow cottonseed

products containing aflatoxin above 300

ppb to be used for feeding beef cattle.

C. Codex Maximum Residue Level

An exemption from temporary

tolerance for residues of A. flavus

isolate AF36 on cotton (40 CFR

180.1206) is currently in effect in

conjunction with an Experimental Use

Permit (61 FR 30235, June 14, 1996, and

extended to expire in December 2001)

(FRL–5377–6).

III. Objections and Hearing Requests

Under section 408(g) of the FFDCA, as

amended by the FQPA, any person may

file an objection to any aspect of this

regulation and may also request a

hearing on those objections. The EPA

procedural regulations which govern the

submission of objections and requests

for hearings appear in 40 CFR part 178.

Although the procedures in those

regulations require some modification to

reflect the amendments made to the

FFDCA by the FQPA of 1996, EPA will

continue to use those procedures, with

appropriate adjustments, until the

necessary modifications can be made.

The new section 408(g) provides

essentially the same process for persons

to ‘‘object’’ to a regulation for an

exemption from the requirement of a

tolerance issued by EPA under new

section 408(d), as was provided in the

old FFDCA sections 408 and 409.

However, the period for filing objections

is now 60 days, rather than 30 days.

A. What Do I Need to Do to File an

Objection or Request a Hearing?

You must file your objection or

request a hearing on this regulation in

accordance with the instructions

provided in this unit and in 40 CFR part

178. To ensure proper receipt by EPA,

you must identify docket control

number OPP–301124 in the subject line

on the first page of your submission. All

requests must be in writing, and must be

mailed or delivered to the Hearing Clerk

on or before july 23, 2001.

1. Filing the request. Your objection

must specify the specific provisions in

the regulation that you object to, and the

grounds for the objections (40 CFR

178.25). If a hearing is requested, the

objections must include a statement of

the factual issues(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). Information submitted in

connection with an objection or hearing

request may be claimed confidential by

marking any part or all of that

information as CBI. Information so

marked will not be disclosed except in

accordance with procedures set forth in

40 CFR part 2. A copy of the

information that does not contain CBI

must be submitted for inclusion in the

public record. Information not marked

confidential may be disclosed publicly

by EPA without prior notice.

Mail your written request to: Office of

the Hearing Clerk (1900), Environmental

Protection Agency, 1200 Pennsylvania

Ave., NW., Washington, DC 20460. You

may also deliver your request to the

Office of the Hearing Clerk in Rm. C400,

Waterside Mall, 401 M St., SW.,

Washington, DC 20460. The Office of

the Hearing Clerk is open from 8 a.m.

to 4 p.m., Monday through Friday,

excluding legal holidays. The telephone

number for the Office of the Hearing

Clerk is (202) 260–4865.

2. Tolerance fee payment. If you file

an objection or request a hearing, you

must also pay the fee prescribed by 40

CFR 180.33(i) or request a waiver of that

fee pursuant to 40 CFR 180.33(m). You

must mail the fee to: EPA Headquarters

Accounting Operations Branch, Office

of Pesticide Programs, P.O. Box

360277M, Pittsburgh, PA 15251. Please

identify the fee submission by labeling

it ‘‘Tolerance Petition Fees.’’

EPA is authorized to waive any fee

requirement‘‘when in the judgement of

the Administrator such a waiver or

refund is equitable and not contrary to

the purpose of this subsection.’’ For

additional information regarding the

waiver of these fees, you may contact

James Tompkins by phone at (703) 305–

5697, by e-mail at

tompkins.jim@epa.gov, or by mailing a

request for information to Mr. Tompkins

at Registration Division (7505C), Office

of Pesticide Programs, Environmental

Protection Agency, 1200 Pennsylvania

Ave., NW., Washington, DC 20460.

If you would like to request a waiver

of the tolerance objection fees, you must

mail your request for such a waiver to:

James Hollins, Information Resources

and Services Division (7502C), Office of

Pesticide Programs, Environmental

Protection Agency, 1200 Pennsylvania

Ave., NW., Washington, DC 20460.

3. Copies for the Docket. In addition

to filing an objection or hearing request

with the Hearing Clerk as described in

Unit VIII.A., you should also send a

copy of your request to the PIRIB for its

inclusion in the official record that is

described in Unit I.B.2. Mail your

copies, identified by docket control

number OPP–301124, to: Public

Information and Records Integrity

Branch, Information Resources and

Services Division (7502C), Office of

Pesticide Programs, Environmental

Protection Agency, 1200 Pennsylvania

Ave., NW., Washington, DC 20460. In

person or by courier, bring a copy to the

location of the PIRIB described in Unit

I.B.2. You may also send an electronic

copy of your request via e-mail to: oppdocket@epa.gov. Please use an ASCII

file format and avoid 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 6.1/8.0 or

ASCII file format. Do not include any

CBI in your electronic copy. You may

also submit an electronic copy of your

request at many Federal Depository

Libraries.

B. When Will the Agency Grant a

Request for a Hearing?

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

issues(s) in the manner sought by the

requestor would be adequate to justify

the action requested (40 CFR 178.32).

IV. Regulatory Assessment

Requirements

This final rule extends a temporary

exemption from the tolerance

requirement under FFDCA section

408(d) in response to a petition

submitted to the Agency. The Office of

Management and Budget (OMB) has

exempted these types of actions from

review under Executive Order 12866,

entitled Regulatory Planning and

Review (58 FR 51735, October 4, 1993).

This final rule does not contain any

28386 Federal Register / Vol. 66, No. 100 / Wednesday, May 23, 2001 / Rules and Regulations

information collections subject to OMB

approval under the Paperwork

Reduction Act (PRA), 44 U.S.C. 3501 et

seq., or impose any enforceable duty or

contain any unfunded mandate as

described under Title II of the Unfunded

Mandates Reform Act of 1995 (UMRA)

(Public Law 104–4). Nor does it require

any special considerations under

Executive Order 12898, entitled Federal

Actions to Address Environmental

Justice in Minority Populations and

Low-Income Populations (59 FR 7629,

February 16, 1994); or OMB review or

any Agency action under Executive

Order 13045, entitled Protection of

Children from Environmental Health

Risks and Safety Risks (62 FR 19885,

April 23, 1997). This action does not

involve any technical standards that

would require Agency consideration of

voluntary consensus standards pursuant

to section 12(d) of the National

Technology Transfer and Advancement

Act of 1995 (NTTAA), Public Law 104–

113, section 12(d) (15 U.S.C. 272 note).

Since tolerances and exemptions that

are established on the basis of a FIFRA

section 18 petition under FFDCA

section 408, such as the [tolerance] in

this final rule, do not require the

issuance of a proposed rule, the

requirements of the Regulatory

Flexibility Act (RFA) (5 U.S.C. 601 et

seq.) do not apply. In addition, the

Agency has determined that this action

will not have a substantial direct effect

on States, on the relationship between

the national government and the States,

or on the distribution of power and

responsibilities among the various

levels of government, as specified in

Executive Order 13132, entitled

Federalism (64 FR 43255, August 10,

1999). Executive Order 13132 requires

EPA to develop an accountable process

to ensure ‘‘meaningful and timely input

by State and local officials in the

development of regulatory policies that

have federalism implications.’’ ‘‘Policies

that have federalism implications’’ is

defined in the Executive Order to

include regulations that have

‘‘substantial direct effects on the States,

on the relationship between the national

government and the States, or on the

distribution of power and

responsibilities among the various

levels of government.’’ This final rule

directly regulates growers, food

processors, food handlers and food

retailers, not States. This action does not

alter the relationships or distribution of

power and responsibilities established

by Congress in the preemption

provisions of FFDCA section 408(n)(4).

For these same reasons, the Agency

has determined that this rule does not

have any ‘‘tribal implications’’ as

described in Executive Order 13175,

entitled Consultation and Coordination

with Indian Tribal Governments (65 FR

67249, November 6, 2000). Executive

Order 13175, requires EPA to develop

an accountable process to ensure

‘‘meaningful and timely input by tribal

officials in the development of

regulatory policies that have tribal

implications.’’ ‘‘Policies that have tribal

implications’’ is defined in the

Executive Order to include regulations

that have ‘‘substantial direct effects on

one or more Indian tribes, on the

relationship between the Federal

government and the Indian tribes, or on

the distribution of power and

responsibilities between the Federal

government and Indian tribes.’’ This

rule will not have substantial direct

effects on tribal governments, on the

relationship between the Federal

government and Indian tribes, or on the

distribution of power and

responsibilities between the Federal

government and Indian tribes, as

specified in Executive Order 13175.

Thus, Executive Order 13175 does not

apply to this rule.’’

V. Submission to Congress and the

Comptroller General

The Congressional Review Act, 5

U.S.C. 801 et seq., as added by the Small

Business Regulatory Enforcement

Fairness Act of 1996, generally provides

that before a rule may take effect, the

agency promulgating the rule must

submit a rule report, which includes a

copy of the rule, to each House of the

Congress and to the Comptroller General

of the United States. EPA will submit a

report containing this rule and other

required information to the U.S. Senate,

the U.S. House of Representatives, and

the Comptroller General of the United

States prior to publication of this final

rule in the Federal Register. This final

rule is not a‘‘major rule’’ as defined by

5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

Environmental protection,

Administrative practice and procedure,

Agricultural commodities, Pesticides

and pests, Reporting and recordkeeping

requirements.

Dated: May 9, 2001.

Janet L. Anderson,

Director, Biopesticide and Pollution

Prevention Division.

Therefore, 40 CFR chapter I is

amended as follows:

PART 180—[AMENDED]

1. The authority citation for part 180

continues to read as follows:

Authority: 21 U.S.C. 321(q), 346(a) and

371.

2. Section 180.1206 is revised to read

as follows:

§ 180.1206 Aspergillus flavus AF36.

Aspergillus flavus AF36 is

temporarily exempt from the

requirement of a tolerance in or on

cotton when used on cotton in Arizona

in accordance with the Experimental

Use Permit 69224–EUP–1. The

temporary exemption from a tolerance

will expire on December 30, 2003.

[FR Doc. 01–12900 Filed 5–22–01; 8:45 am]

BILLING CODE 6560–50–S

ENVIRONMENTAL PROTECTION

AGENCY

40 CFR Part 180

[OPP–301132; FRL–6784–7]

RIN 2070–AB78

Thiamethoxam; Pesticide Tolerance

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Final rule.

SUMMARY: This regulation establishes

tolerances for combined residues of

thiamethoxam and its metabolite in or

on tuberous and corm vegetables crop

subgroup, fruiting vegetables crop

group, tomato paste, cucurbit vegetables

crop group, and pome fruits crop group.

Syngenta Crop Protection, Inc.

requested these tolerances under the

Federal Food, Drug, and Cosmetic Act,

as amended by the Food Quality

Protection Act of 1996.

DATES: This regulation is effective May

23, 2001. Objections and requests for

hearings, identified by docket control

number OPP–301132, must be received

by EPA on or before July 23, 2001.

ADDRESSES: Written objections and

hearing requests may be submitted by

mail, in person, or by courier. Please

follow the detailed instructions for each

method as provided in Unit VI. of the

SUPPLEMENTARY INFORMATION. To ensure

proper receipt by EPA, your objections

and hearing requests must identify

docket control number OPP–301132 in

the subject line on the first page of your

response.

FOR FURTHER INFORMATION CONTACT: By

mail: Dani Daniel, Registration Division

(7505C), Office of Pesticide Programs,

Environmental Protection Agency, 1200

Pennsylvania Ave., NW.,Washington,

DC 20460; telephone number: (703)

305–5409; and e-mail address:

daniel.dani@epa.gov.

SUPPLEMENTARY INFORMATION: