[Federal Register Volume 63, Number 52 (Wednesday, March 18, 1998)]
[Rules and Regulations]
[Pages 13126-13128]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-6387]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-300622; FRL-5773-1]
RIN 2070-AB78
Tebufenozide; Extension of Tolerance for Emergency Exemptions
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This rule extends a time-limited tolerance for residues of the
insecticide tebufenozide and its metabolites in or on non-brassica
leafy vegetables (Crop Group 4) at 5.0 part per million (ppm), brassica
(cole) leafy vegetables (Crop Group 5) at 5.0 ppm, and turnip tops at
5.0 ppm for an additional 1-year period, to February 28, 1999. 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 leafy vegetables, brassica
leafy vegetables, and turnip tops. 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 March 18, 1998. Objections and
requests for hearings must be received by EPA, on or before May 18,
1998.
ADDRESSES: Written objections and hearing requests, identified by the
docket control number, [OPP-300622], 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-300622], 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: Andrew Ertman, 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. 278, CM #2, 1921
Jefferson Davis Hwy., Arlington, VA 22202, (703)-308-9367; e-mail:
ertman.andrew@epamail.epa.gov.
SUPPLEMENTARY INFORMATION: EPA issued a final rule, published in the
Federal Register of March 5, 1997 (62 FR 9984) (FRL-5591-7), 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 a time-limited
tolerance for the residues of tebufenozide and its metabolites in or on
non-brassica leafy vegetables (Crop Group 4) at 5.0 ppm, brassica
(cole) leafy vegetables (Crop Group 5) at 5.0 ppm, and turnip tops at
5.0 ppm, with an expiration date of February 28, 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 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 tebufenozide on leafy
vegetables, brassica leafy vegetables, and turnip tops for this year
growing season because there are no viable alternative products due to
the beet armyworm's (BAW) and diamondback moth's proclivity for
developing resistance to all classes of insecticides. It was asserted
that the last five years have seen a marked increase in the amounts of
active ingredient necessary to achieve control of the BAW in
vegetables, and during 1995 many growers reported failures with all
products and combinations. This increase of pesticide use has lead to
the pest developing a high tolerance to these chemicals. This tolerance
has in turn allowed the pest to develop high populations which cause
economic damage to the various cole and leafy vegetable crops. These
pests tend to do the most damage to the crowns or growing points of
young plants. Other damage is to the harvestable heads, in which they
contaminate and lower the quality of the produce. The applicant
contends that without new chemistry to combat these pests, growers will
continue to suffer significant economic losses. After having reviewed
the submission, EPA concurs that emergency conditions exist for this
state. EPA has authorized under FIFRA section 18 the use of
tebufenozide on leafy vegetables, brassica lelafy vegetables, and
turnip tops for control of the beet armyworm and diamondback moth in
California and the beet armyworm in Texas.
EPA assessed the potential risks presented by residues of
tebufenozide in or on leafy vegetables, brassica leafy vegetables, and
turnip tops. In doing so, EPA considered the new safety standard
[[Page 13127]]
in FFDCA section 408(b)(2), and decided that the necessary tolerance
under FFDCA section 408(l)(6) would be consistent with the new safety
standard and with FIFRA section 18. The data and other relevant
material have been evaluated and discussed in the final rule of March
5, 1997 (62 FR 9984). 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 1-year period.
Although this tolerance will expire and is revoked on February 28,
1999, under FFDCA section 408(l)(5), residues of the pesticide not in
excess of the amounts specified in the tolerance remaining in or on
leafy vegetables, brassica leafy vegetables, and turnip tops 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 May 18, 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-300622]. 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 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.
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
[[Page 13128]]
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: February 26, 1998.
James Jones,
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, by amending paragraph (b) in the table, for the
commodities ``Leafy vegetable (Cole-brassica),'' ``Leafy vegetables
(non-brassica),'' and ``Turnip tops'' by removing ``2/28/98'' and by
adding in its place ``2/28/99''.
[FR Doc. 98-6387 Filed 3-17-98; 8:45 am]
BILLING CODE 6560-50-F
