[Federal Register Volume 63, Number 152 (Friday, August 7, 1998)]
[Rules and Regulations]
[Pages 42246-42248]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-21203]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-300694; FRL-6021-2]
RIN 2070-AB78
Avermectin; Extension of Tolerance for Emergency Exemptions
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: This rule extends a time-limited tolerance for residues of the
insecticide and miticide avermectin B1 and its delta-8,9-isomer in or
on spinach and celeriac at 0.05 part per million (ppm) for an
additional 18 month period, to January 31, 2000. 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 spinach and celeriac. 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 August 7, 1998. Objections and
requests for hearings must be received by EPA, on or before October 6,
1998.
ADDRESSES: Written objections and hearing requests, identified by the
docket control number, [OPP-300694], 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-300694], 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: [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: Daniel J. Rosenblatt,
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)
308-9375; e-mail: [email protected]. .
SUPPLEMENTARY INFORMATION: EPA issued a final rule, published in the
Federal Register of August 19, 1997 (62 FR 44089) (FRL-5737-1), 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 avermectin and its metabolites in or on
spinach and celeriac at 0.05 ppm, with an expiration date of July 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 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 avermectin on spinach
and celeriac for this year's growing season due to the yield losses
associated with the two-spotted spider mite in celeriac and the
leafminer in spinach. After having reviewed the submission, EPA concurs
that emergency conditions exist. EPA has authorized under FIFRA section
18 the use of avermectin on spinach and celeriac.
EPA assessed the potential risks presented by residues of
avermectin in or on spinach and celeriac. 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 August 19, 1997 (62 FR 44089). 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 18 month period. Although this tolerance will expire
and is revoked on January 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 spinach and celeriac 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.
[[Page 42247]]
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 October 6, 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 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-300694]. 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 issued 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 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
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 this 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: July 29, 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.
[[Page 42248]]
Sec. 180.449 [Amended]
2. In Sec. 180.449, by amending paragraph (b) in the table, for the
commodities ``celeriac'' and ``spinach'' by revising the date ``7/31/
98'' to read ``1/31/00''.
[FR Doc. 98-21203 Filed 8-6-98; 8:45 am]
BILLING CODE 6560-50-F