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Tebuconazole; Extension of Tolerances for Emergency Exemptions
Note: EPA no longer updates this information, but it may be useful as a reference or resource.
[Federal Register: October 7, 1998 (Volume 63, Number 194)]
[Rules and Regulations]
[Page 53813-53815]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr07oc98-983]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-300729; FRL-6034-7]
RIN 2070-AB78
Tebuconazole; Extension of Tolerances for Emergency Exemptions
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This rule extends time-limited tolerances for residues of the
fungicide tebuconazole and its metabolites in or on sunflower, seed and
sunflower, oil at 0.2 and 0.4 parts per million (ppm) for an additional
1-year period, to September 30, 1999. This action is in response to
EPA's granting of emergency exemptions under section 18 of the Federal
Insecticide, Fungicide, and Rodenticide Act authorizing use of the
pesticide on sunflowers. Section 408(l)(6) of the Federal Food, Drug,
and Cosmetic Act (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.
DATES: This regulation becomes effective October 7, 1998. Objections
and requests for hearings must be received by EPA, on or before
December 7, 1998.
ADDRESSES: Written objections and hearing requests, identified by the
docket control number, [OPP-300729], 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-300729], 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, 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: opp-docket@epamail.epa.gov. Follow the instructions in
Unit II. of this preamble. No Confidential Business Information (CBI)
should be submitted through e-mail.
FOR FURTHER INFORMATION CONTACT: By mail: Stephen Schaible,
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. 267, Crystal
Mall #2, 1921 Jefferson Davis Hwy., Arlington, VA 22202, (703)-308-
9362; e-mail: schaible.stephen@epamail.epa.gov.
SUPPLEMENTARY INFORMATION: EPA issued a final rule, published in the
Federal Register of October 29, 1997 (62 FR 56089) (FRL-5752-4), which
announced that on its own initiative and under section 408(e) of the
FFDCA, 21 U.S.C. 346a(e) and (l)(6), it established time-limited
tolerances for the residues of tebuconazole and its metabolites in or
on sunflower, seed and sunflower, oil at 0.2 and 0.4 ppm, with an
expiration date of September 30, 1998. EPA established the tolerances
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 received a request to extend the use of tebuconazole on
sunflowers for this year's growing season due to the continued
emergency situation facing sunflower growers in Colorado, Kansas,
Nebraska and North Dakota. Rust outbreaks in 1996 and 1997 have
resulted in a buildup of inoculum, making the potential for an outbreak
probable given favorable environmental conditions . After having
reviewed the submission, EPA concurs that emergency conditions exist
for these states. EPA has authorized under FIFRA section 18 the use of
tebuconazole on sunflowers for control of rust in sunflowers.
EPA assessed the potential risks presented by residues of
tebuconazole in or on sunflower seed and sunflower oil. In doing so,
EPA considered the new safety standard in FFDCA section 408(b)(2), and
decided that the necessary tolerances under FFDCA section 408(l)(6)
would be consistent with the new safety standard and with
[[Page 53814]]
FIFRA section 18. The data and other relevant material have been
evaluated and discussed in the final rule of October 29, 1997 (62 FR
56089). Based on that data and information considered, the Agency
reaffirms that extension of the time-limited tolerances will continue
to meet the requirements of section 408(l)(6). Therefore, the time-
limited tolerances are extended for an additional 1-year period.
Although these tolerances will expire and are revoked on September 30,
1999, under FFDCA section 408(l)(5), residues of the pesticide not in
excess of the amounts specified in the tolerances remaining in or on
sunflower, seed and sunflower, oil 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 December 7, 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'scontentions 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
thatdoes 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 51/6.1 or ASCII file format. All copies of objections and
hearing requests in electronic form must be identified by the docket
control number [OPP-300729]. 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
A. Certain Acts and Executive Orders
This final rule extends a time-limited tolerance that was
previously extended by EPA 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). In addition, 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).
Since this extension of an existing time-limited tolerance does 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.
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
[[Page 53815]]
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 to 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 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 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 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: September 28, 1998.
Arnold E. Layne,
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. 180.474 [Amended]
2. In Sec. 180.474, by amending paragraph (b)(1) by changing the
date for ``sunflower oil'' and ``sunflower seed'' from ``9/30/98'' to
read ``9/30/99.''
[FR Doc. 98-26785 Filed 10-6-98; 8:45 am]
BILLING CODE 6560-50-F