[Federal Register Volume 64, Number 14 (Friday, January 22, 1999)]
[Rules and Regulations]
[Pages 3428-3431]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-1479]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-300774; FRL-6053-4]
RIN 2070-AB78


Tebufenozide; Extension of Tolerance for Emergency Exemptions

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation extends a time-limited tolerance for residues 
of the insecticide tebufenozide and its metabolites in or on sugarcane 
at 0.3 part per million (ppm) for an additional 2-year period. This 
tolerance will expire and is revoked on December 31, 2000. This 
regulation also amends the tolerance level, due to a typographical 
error in the original document published by EPA in the Federal Register 
on November 26, 1997. This action is in response to EPA's granting of 
an emergency exemption under section 18 of the Federal Insecticide, 
Fungicide, and Rodenticide Act (FIFRA) authorizing use of the pesticide 
on sugarcane. Section 408(l)(6) of the Federal Food, Drug, and Cosmetic 
Act 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 FIFRA section 18.

DATES: This regulation becomes effective January 22, 1999. Objections 
and requests for hearings must be received by EPA, on or before March 
23, 1999.

ADDRESSES: Written objections and hearing requests, identified by the 
docket control number OPP-300774, 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

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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-300774], 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. 119, Crystal Mall 2 (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: [email protected]. 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 objections and 
hearing requests will also be accepted on disks in WordPerfect 5.1/6.1 
or ASCII file format. All copies of electronic objections and hearing 
requests must be identified by the docket control number OPP-300774. 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.

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, CM #2, 1921 
Jefferson Davis Hwy., Arlington, VA, (703) 308-9358, 
[email protected].

SUPPLEMENTARY INFORMATION: EPA issued a final rule, published in the 
Federal Register of November 26, 1997 (62 FR 62979) (FRL-5751-1), which 
announced that on its own initiative under section 408 of the Federal 
Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a(e) and (l)(6), as 
amended by the Food Quality Protection Act of 1996 (FQPA) (Pub. L. 104-
170) it established a time-limited tolerance for the residues of 
tebufenozide and its metabolites in or on sugarcane at 0.3 ppm, with an 
expiration date of December 31, 1998. 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 FIFRA section 18. Such tolerances can be established without 
providing notice or period for public comment.
    EPA received a request to extend the use of tebufenozide on 
sugarcane for this year's growing season due to the continuing need to 
control the pest, sugarcane borer. The applicant, the Louisiana Dept. 
of Agriculture & Forestry, had for several years used the chemical 
azinphos-methyl to control this pest. However, use of that product has 
been eliminated, leaving no registered alternative measures to control 
the borer. After having reviewed the submission, EPA concurs that 
emergency conditions exist. EPA has authorized under FIFRA section 18 
the use of tebufenozide on sugarcane for control of sugarcane borer.
    EPA is also, at this time, amending the tolerance value for the 
time-limited tolerance for residues of tebufenozide on sugarcane 
resulting from use authorized by EPA under section 18. The regulation 
published by EPA in the Federal Register on November 26, 1997, (FRL-
5751-1), contained a typographical error which identified the tolerance 
level as ``0.03 ppm'' instead of the correct tolerance level, which is 
``0.3 ppm.'' The risk assessment performed by EPA in response to this 
action in 1997, and discussed in detail in the November 26, 1997 
Federal Register document, had identified the appropriate tolerance 
level at ``0.3 ppm.'' EPA is taking this current action on its own 
initiative.
    EPA assessed the potential risks presented by residues of 
tebufenozide in or on sugarcane. In doing so, EPA considered the safety 
standard in FFDCA section 408(b)(2), and decided that the necessary 
tolerance under FFDCA section 408(l)(6) would be consistent with the 
safety standard and with FIFRA section 18. The data and other relevant 
material have been evaluated and discussed in the final rule of 
November 26, 1997 (62 FR 62979) (FRL-5751-1). Based on that data and 
information considered, the Agency reaffirms that extension of the 
time-limited tolerance will continue to meet the requirements of 
section 408(l)(6).
    Therefore, the time-limited tolerance is extended for an additional 
2-year period. EPA will publish a document in the Federal Register to 
remove the revoked tolerance from the Code of Federal Regulations 
(CFR). Although this tolerance will expire and is revoked on December 
31, 2000, under FFDCA section 408(l)(5), residues of the pesticide not 
in excess of the amounts specified in the tolerance remaining in or on 
sugarcane 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 FFDCA section 408(g) provides essentially the same process 
for persons to ``object'' to a tolerance regulation issued by EPA under 
new section 408(e) and (l)(6) as was provided in the old section 408 
and in section 409. 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 March 23, 1999, 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 under the ``ADDRESSES'' section (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). 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 tolerance objection fee waivers, 
contact James Tompkins, 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. 239, CM #2, 1921 Jefferson Davis Hwy., Arlington, VA, 
(703) 305-5697, [email protected]. Requests for waiver of tolerance 
objection fees should be sent to James Hollins, Information Resources 
and Services Division (7502C), Office of Pesticide Programs, 
Environmental Protection Agency, 401 M St., SW., Washington, DC 20460.

[[Page 3430]]

    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

    EPA has established a record for this regulation under docket 
control number [OPP-300774] (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 8:30 a.m. 
to 4 p.m., Monday through Friday, excluding legal holidays. The public 
record is located in Room 119 of the Public Information and Records 
Integrity Branch, Information Resources and Services Division (7502C), 
Office of Pesticide Programs, Environmental Protection Agency, CM #2, 
1921 Jefferson Davis Hwy., Arlington, VA.
    Objections and hearing requests may be sent by e-mail directly to 
EPA at:
    [email protected].


    E-mailed objections and hearing requests must be submitted as an 
ASCII file avoiding the use of special characters and any form of 
encryption.
    The official record for this regulation, as well as the public 
version, as described in this unit 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 record which 
will also include all comments submitted directly in writing. The 
official record is the paper record maintained at the Virginia address 
in ``ADDRESSES'' at the beginning of this document.

III. Regulatory Assessment Requirements

A. Certain Acts and Executive Orders

    This final rule establishes a tolerance under section 408 of the 
FFDCA. 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 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 tolerances and exemptions that are established 
under section 408(l)(6) of FFDCA, 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 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.

B. Executive Order 12875

    Under Executive Order 12875, entitled Enhancing the 
Intergovernmental Partnership (58 FR 58093, October 28, 1993), EPA may 
not issue a regulation that is not required by statute and that creates 
a mandate upon a State, local or tribal government, unless the federal 
government provides the funds necessary to pay the direct compliance 
costs incurred by those governments. If the mandate is unfunded, EPA 
must provide to OMB a description of the extent of EPA's prior 
consultation with representatives of affected State, local, and tribal 
governments, the nature of their concerns, copies of any written 
communications from the governments, and a statement supporting the 
need to issue the regulation. In addition, Executive Order 12875 
requires EPA to develop an effective process permitting elected 
officials and other representatives of State, local, and tribal 
governments ``to provide meaningful and timely input in the development 
of regulatory proposals containing significant unfunded mandates.''
    Today's rule does not create an unfunded Federal mandate on State, 
local, or tribal governments. The rule does not impose any enforceable 
duties on these entities. Accordingly, the requirements of section 1(a) 
of Executive Order 12875 do not apply to this rule.

C. Executive Order 13084

    Under Executive Order 13084, entitled Consultation and Coordination 
with Indian Tribal Governments (63 FR 27655, May 19, 1998), EPA may not 
issue a regulation that is not required by statute, that significantly 
or uniquely affects the communities of Indian tribal governments, and 
that imposes substantial direct compliance costs on those communities, 
unless the Federal government provides the funds necessary to pay the 
direct compliance costs incurred by the tribal governments. If the 
mandate is unfunded, EPA must provide OMB, in a separately identified 
section of the preamble to the rule, a description of the extent of 
EPA's prior consultation with representatives of affected tribal 
governments, a summary of the nature of their concerns, and a statement 
supporting the need to issue the regulation. In addition, Executive 
Order 13084 requires EPA to develop an effective process permitting 
elected officials and other representatives of Indian tribal 
governments ``to provide meaningful and timely input in the development 
of regulatory policies on matters that significantly or uniquely affect 
their communities.''
    Today's rule does not significantly or uniquely affect the 
communities of Indian tribal governments. This action does not involve 
or impose any requirements that affect Indian tribes. Accordingly, the 
requirements of

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section 3(b) of Executive Order 13084 do not apply to this rule.

IV. 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 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 the rule in the Federal Register. This 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: December 29, 1998.

Tina E. Levine,

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.

Sec. 180.482  [Amended]

    2. In Sec. 180.482, paragraph (b), in the table, amend the entry 
``Sugarcane' by revising the tolerance level ``0.03'' to read ``0.3'' 
and the date ``12/31/98'' to read ``12/31/00''.

[FR Doc. 99-1479 Filed 1-21-99; 8:45 am]
BILLING CODE 6560-50-F