Federal Register / Vol. 62, No. 239 / Friday, December 12, 1997 / Rules and Regulations 65367

there is no adverse economic impact.

The factual basis for the Agency’s

generic certification for tolerance

actions published on May 4, 1981 (46

FR 24950), and was provided to the

Chief Counsel for Advocacy of the Small

Business Administration.

IV. Submission to Congress and the

General Accounting Office

Under 5 U.S.C. 801(a)(1)(A), as added

by the Small Business Regulatory

Enforcement Fairness Act of 1996, the

Agency has submitted 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 General

Accounting Office prior to publication

of this rule in today’s Federal Register.

This 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: November 26, 1997.

Peter Caulkins,

Acting Director, Registration Division, Office

of Pesticide Programs.

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. 346a and 371.

§ 180.472 [Amended]

2. In § 180.472, by amending

paragraph (a) in the table, for the

commodities ‘‘beet roots,’’ ‘‘beet tops,’’

‘‘turnip roots,’’ and ‘‘turnip tops’’ by

removing ‘‘November 29, 1997’’ and

adding in its place ‘‘November 29,

1998’’.

[FR Doc. 97–32550 Filed 12–11–97; 8:45 am]

BILLING CODE 6560–50–F

ENVIRONMENTAL PROTECTION

AGENCY

40 CFR Part 180

[OPP–300591; FRL–5760–4]

RIN 2070–AB78

Myclobutanil; Tolerance Extension for

Emergency Exemptions

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Final rule.

SUMMARY: This rule extends a timelimited tolerance for residues of the

fungicide myclobutanil and its

metabolites in or on cucurbits at 0.3

parts per million (ppm) for an

additional 1-year period, to November

30, 1998. This action is in response to

EPA’s granting of an emergency

exemption under section 18 of the

Federal Insecticide, Fungicide, and

Rodenticide Act authorizing use of the

pesticide on cucurbit vegetables.

Section 408(l)(6) of the FFDCA requires

EPA to establish a time-limited

tolerance or exemption from the

requirement for a tolerance for pesticide

chemical residues in food that will

result from the use of a pesticide under

an emergency exemption granted by

EPA under section 18 of FIFRA.

EFFECTIVE DATE: This regulation

becomes effective December 12, 1997.

Objections and requests for hearings

must be received by EPA, on or before

February 10, 1998.

ADDRESSES: Written objections and

hearing requests, identified by the

docket control number, [OPP–300447],

must 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 identified

by the docket control number, [OPP–

300591], must also be submitted to:

Public Information and Records

Integrity Branch, Information Resources

and Services Division (7502C), Office of

Pesticide Programs, Environmental

Protection Agency, 401 M St., SW.,

Washington, DC 20460. In person, bring

a copy of objections and hearing

requests to Rm. 1132, Crystal Mall #2,

1921 Jefferson Davis Hwy., Arlington,

VA.

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. Follow the

instructions in Unit II. of this preamble.

No Confidential Business Information

(CBI) should be submitted through email.

FOR FURTHER INFORMATION CONTACT: By

mail: David Deegan, Registration

Division (7505C), Office of Pesticide

Programs, Environmental Protection

Agency, 401 M St., SW., Washington,

DC 20460. Office location, telephone

number, and e-mail address: Rm. 280,

Crystal Mall #2, 1921 Jefferson Davis

Hwy., Arlington, VA 22202, (703)–308–

9358; e-mail:

deegan.dave@epamail.epa.gov.

SUPPLEMENTARY INFORMATION: EPA

issued a final rule, published in the

Federal Register of January 9, 1997 (62

FR 1284) (FRL–5579–7), which

announced that on its own initiative

and under section 408(e) of the Federal

Food, Drug, and Cosmetic Act (FFDCA),

21 U.S.C. 346a(e) and (l)(6), it

established a time-limited tolerance for

the residues of myclobutanil and its

metabolites in or on cucurbit vegetables

at 0.3 ppm, with an expiration date of

November 30, 1997. EPA established the

tolerance because section 408(l)(6) of

the FFDCA requires EPA to establish a

time-limited tolerance or exemption

from the requirement for a tolerance for

pesticide chemical residues in food that

will result from the use of a pesticide

under an emergency exemption granted

by EPA under section 18 of FIFRA. Such

tolerances can be established without

providing notice or period for public

comment.

EPA established the initial tolerance

in response to a section 18 authorization

granted to the state of California for use

of myclobutanil on cucurbit vegetables

in July 1996. EPA granted this use to

California consistent with provisions of

section 18 of FIFRA, after finding that

there was an emergency condition in the

state requiring use of this product.

When EPA established the time-limited

tolerance it did so consistent with a

review of available information as

required under section 408(l)(6) of the

FFDCA. EPA is taking action now to

extend this tolerance because the

Agency authorized, as allowed under

section 18, this use to occur in the states

of Arizona and Hawaii to control

powdery mildew on cucurbit vegetables

(Arizona) and limited to watermelons

(Hawaii). This authorization occurred

on May 8, 1997, and allowed use of the

product for one year.

EPA assessed the potential risks

presented by residues of myclobutanil

in or on cucurbit vegetables. In doing so,

EPA considered the new safety standard

in FFDCA section 408(b)(2) of the

FFDCA, and decided that the necessary

tolerance under FFDCA section 408(l)(6)

of the FFDCA would be consistent with

the new safety standard and with

section 18 of FIFRA. The data and other

relevant material have been evaluated

and discussed in the final rule

published in the Federal Register of

January 9, 1997. Based on that data and

information considered, the Agency

reaffirms that extension of the timelimited tolerance will continue to meet
65368 Federal Register / Vol. 62, No. 239 / Friday, December 12, 1997 / Rules and Regulations

the requirements of section 408(l)(6) of

the FFDCA. Therefore, the time-limited

tolerance is extended for an additional

1-year period. Although this tolerance

will expire and is revoked on November

30, 1998, under section 408(l)(5) of the

FFDCA, residues of the pesticide not in

excess of the amounts specified in the

tolerance remaining in or on cucurbit

vegetables after that date will not be

unlawful, provided the pesticide is

applied in a manner that was lawful

under FIFRA and the application

occurred prior to the revocation of the

tolerance. EPA will take action to revoke

this tolerance earlier if any experience

with, scientific data on, or other

relevant information on this pesticide

indicate that the residues are not safe.

I. Objections and Hearing Requests

The new section 408(g) of the FFDCA

provides essentially the same process

for persons to ‘‘object’’ to a tolerance

regulation issued by EPA under new

section 408(e) and (l)(6) of the FFDCA

as was provided in the old section 408

and in section 409 of the FFDCA.

However, the period for filing objections

is 60 days, rather than 30 days. EPA

currently has procedural regulations

which govern the submission of

objections and hearing requests. These

regulations will require some

modification to reflect the new law.

However, until those modifications can

be made, EPA will continue to use those

procedural regulations with appropriate

adjustments to reflect the new law.

Any person may, by February 10,

1998, file written objections to any

aspect of this 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 issues on which

a hearing is requested, the requestor’s

contentions on such issues, and a

summary of any evidence relied upon

by the requestor (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

issues in the manner sought by the

requestor would be adequate to justify

the action requested (40 CFR 178.32).

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.

II. Public Record and Electronic

Submissions

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 Virginia

address in ‘‘ADDRESSES’’ at the

beginning of this document.

Electronic comments may be sent

directly to EPA at:

opp-docket@epamail.epa.gov.

Electronic objections and hearing

requests must be submitted as an ASCII

file avoiding the use of special

characters and any form of encryption.

Objections and hearing requests will

also be accepted on disks in

WordPerfect 5.1/6.1 or ASCII file

format. All copies of objections and

hearing requests in electronic form must

be identified by the docket control

number [OPP–300591]. No 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.

III. Regulatory Assessment

Requirements

This final rule extends a time-limited

tolerance 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 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) (Pub. L.

104-4). Nor does it require any prior

consultation as specified by Executive

Order 12875, entitled Enhancing the

Intergovernmental Partnership (58 FR

58093, October 28, 1993), or special

considerations as required by Executive

Order 12898, entitled Federal Actions to

Address Environmental Justice in

Minority Populations and Low-Income

Populations (59 FR 7629, February 16,

1994), or require OMB review in

accordance with Executive Order 13045,

entitled Protection of Children from

Environmental Health Risks and Safety

Risks (62 FR 19885, April 23, 1997).

In addition, since these tolerances and

exemptions that are established on the

basis of a petition under FFDCA section

408 (d), 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.

Nevertheless, the Agency has previously

assessed whether establishing

tolerances, exemptions from tolerances,

raising tolerance levels or expanding

exemptions might adversely impact

small entities and concluded, as a

generic matter, that there is no adverse

economic impact. The factual basis for

the Agency’s generic certification for

tolerance actions published on May 4,

1981 (46 FR 24950), and was provided

to the Chief Counsel for Advocacy of the

Small Business Administration.

IV. Submission to Congress and the

General Accounting Office

Under 5 U.S.C. 801(a)(1)(A), as added

by the Small Business Regulatory

Enforcement Fairness Act of 1996, the

Agency has submitted 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 General

Accounting Office prior to publication

of this rule in today’s Federal Register.

This 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.
Federal Register / Vol. 62, No. 239 / Friday, December 12, 1997 / Rules and Regulations 65369

Dated: November 25, 1997.

Peter Caulkins,

Acting Director, Registration Division, Office

of Pesticide Programs.

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. 346a and 371.

§ 180.443 [Amended]

2. In § 180.443, by amending

paragraph (b) in the table, for the

commodity ‘‘cucurbit vegetables’’ by

removing ‘‘November 30, 1997’’and

adding in its place ‘‘November 30,

1998’’.

[FR Doc. 97–32549 Filed 12–11–97; 8:45 am]

BILLING CODE 6560–50–F

ENVIRONMENTAL PROTECTION

AGENCY

40 CFR Part 180

[OPP–300590; FRL–5759–5]

RIN 2070–AB78

Chlorothalonil; Pesticide Tolerances

for Emergency Exemptions

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Final rule.

SUMMARY: This regulation establishes a

time-limited tolerance for residues of

chlorothalonil in or on ginseng. This

action is in response to EPA’s granting

of an emergency exemption under

section 18 of the Federal Insecticide,

Fungicide, and Rodenticide Act

authorizing use of the pesticide on

ginseng. This regulation establishes a

maximum permissible level for residues

of chlorothalonil and its metabolite 4-

hydroxy-2,5,6-

trichloroisophthalonitrile, expressed as

chlorothalonil, in this food commodity

pursuant to section 408(l)(6) of the

Federal Food, Drug, and Cosmetic Act,

as amended by the Food Quality

Protection Act of 1996. The tolerance

will expire and is revoked on December

31, 1998.

DATES: This regulation is effective

December 12, 1997. Objections and

requests for hearings must be received

by EPA on or before February 10, 1998.

ADDRESSES: Written objections and

hearing requests, identified by the

docket control number, [OPP–300590],

must 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 identified

by the docket control number, [OPP–

300590], must also be submitted to:

Public Information and Records

Integrity Branch, Information Resources

and Services Division (7502C), Office of

Pesticide Programs, Environmental

Protection Agency, 401 M St., SW.,

Washington, DC 20460. In person, bring

a copy of objections and hearing

requests to Rm. 1132, CM #2, 1921

Jefferson Davis Hwy., Arlington, VA.

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 5.1/6.1 file

format or ASCII file format. All copies

of objections and hearing requests in

electronic form must be identified by

the docket control number [OPP–

300590]. 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.

FOR FURTHER INFORMATION CONTACT: By

mail: Olga Odiott, Registration Division

7505C, Office of Pesticide Programs,

Environmental Protection Agency, 401

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

Office location, telephone number, and

e-mail address: Crystal Mall #2, 1921

Jefferson Davis Hwy., Arlington, VA,

(703) 308-9363, e-mail:

odiott.olga@epamail.epa.gov.

SUPPLEMENTARY INFORMATION: EPA, on

its own initiative, pursuant to section

408(e) and (l)(6) of the Federal Food,

Drug, and Cosmetic Act (FFDCA), 21

U.S.C. 346a(e) and (l)(6), is establishing

a tolerance for residues of the fungicide

chlorothalonil and its 4-hydroxy-2,5,6-

trichloroisophthalonitrile metabolite,

expressed as chlorothalonil, in or on

ginseng at 0.10 parts per million (ppm).

This tolerance will expire and is

revoked on December 31, 1998. EPA

will publish a document in the Federal

Register to remove the revoked

tolerance from the Code of Federal

Regulations.

I. Background and Statutory Authority

The Food Quality Protection Act of

1996 (FQPA) (Pub. L. 104–170) was

signed into law August 3, 1996. FQPA

amends both the Federal Food, Drug,

and Cosmetic Act (FFDCA), 21 U.S.C.

301 et seq., and the Federal Insecticide,

Fungicide, and Rodenticide Act

(FIFRA), 7 U.S.C. 136 et seq. The FQPA

amendments went into effect

immediately. Among other things,

FQPA amends FFDCA to bring all EPA

pesticide tolerance-setting activities

under a new section 408 with a new

safety standard and new procedures.

These activities are described below and

discussed in greater detail in the final

rule establishing the time-limited

tolerance associated with the emergency

exemption for use of propiconazole on

sorghum (61 FR 58135, November 13,

1996) (FRL–5572–9).

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

FFDCA allows EPA to establish a

tolerance (the legal limit for a pesticide

chemical residue in or on a food) only

if EPA determines that the tolerance is

‘‘safe.’’ Section 408(b)(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....’’

Section 18 of FIFRA authorizes EPA

to exempt any Federal or State agency

from any provision of FIFRA, if EPA

determines that ‘‘emergency conditions

exist which require such exemption.’’

This provision was not amended by

FQPA. EPA has established regulations

governing such emergency exemptions

in 40 CFR part 166.

Section 408(l)(6) of the FFDCA

requires EPA to establish a time-limited

tolerance or exemption from the

requirement for a tolerance for pesticide

chemical residues in food that will

result from the use of a pesticide under

an emergency exemption granted by

EPA under section 18 of FIFRA. Such

tolerances can be established without

providing notice or period for public

comment.