[Federal Register Volume 63, Number 6 (Friday, January 9, 1998)]
[Rules and Regulations]
[Pages 1377-1379]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-561]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-300600; FRL-5764-6]
RIN 2070-AB78
Bifenthrin; 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 bifenthrin in or on broccoli and cauliflower at 0.1 and
0.05 parts per million (ppm), respectively, for an additional 1-year
period, to January 31, 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 September 19, 1997, under the crisis provisions.
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 January 9, 1998. Objections
and requests for hearings must be received by EPA, on or before March
10, 1998.
ADDRESSES: Written objections and hearing requests, identified by the
docket control number, [OPP-300600], 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-300600], 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: [email protected]. 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: Andrea Beard, 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, CM #2, 1921
Jefferson Davis Hwy., Arlington, VA 22202, (703)-308-9356; e-mail:
[email protected].
SUPPLEMENTARY INFORMATION: EPA issued a final rule, published in the
Federal Register of February 12, 1997 (62 FR 6486) (FRL-5585-1), 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 bifenthrin in or on broccoli and
cauliflower at 0.1 and 0.05 ppm, respectively, with an expiration date
of January 31, 1998. EPA established the tolerance because section
408(l)(6) of the FFDCA requires
[[Page 1378]]
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 bifenthrin on broccoli
and cauliflower for this year's growing season due to the circumstances
of there being no effective material available for late season control
of the silverleaf whitefly, a relatively newly established pest, which
has caused serious damage to vegetable crops in recent years. After
having reviewed the submission, EPA concurs that emergency conditions
exist for this state. EPA has authorized under FIFRA section 18 the use
of bifenthrin on broccoli and cauliflower for control of whiteflies in
California.
EPA assessed the potential risks presented by residues of
bifenthrin in or on cauliflower and broccoli. In doing so, EPA
considered the new 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 new safety standard and with FIFRA section
18. The data and other relevant material have been evaluated and
discussed in the final rule of February 12, 1997 (62 FR 6486). 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 January 31, 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 broccoli and
cauliflower 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 March 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:
[email protected].
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-300600]. 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).
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
[[Page 1379]]
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, EPA 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: December 23, 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.
Sec. 180.442 [Amended]
2. In Sec. 180.442, by amending paragraph (b) in the table, for the
commodities ``broccoli'' and ``cauliflower'' by removing ``1/31/98''and
by adding in its place ``1/31/99''.
[FR Doc. 98-561 Filed 1-8-98; 8:45 am]
BILLING CODE 6560-50-F