[Federal Register Volume 63, Number 20 (Friday, January 30, 1998)]
[Rules and Regulations]
[Pages 4585-4586]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-2212]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-300604; FRL-5766-5]
RIN 2070-AB78
Carboxin; 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
fungicide carboxin and its metabolites in or on onion seed at 0.2 parts
per million (ppm) 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 onion seed.
Additionally, this rule changes the commodity expression for the
tolerance from ``onion seed'' to ``onions, dry bulb.'' 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 30, 1998. Objections
and requests for hearings must be received by EPA, on or before March
31, 1998.
ADDRESSES: Written objections and hearing requests, identified by the
docket control number, [OPP-300604], 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-300604], 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: 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, CM #2,
1921 Jefferson Davis Hwy., Arlington, VA 22202, (703)-308-9362; e-mail:
[email protected].
SUPPLEMENTARY INFORMATION: EPA issued a final rule, published in the
Federal Register of February 3, 1997 (62 FR 4911) (FRL-5584-5), 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 carboxin and its metabolites in or on
onion seed at 0.2 ppm, with an expiration date of January 17, 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 carboxin on onion seed
for this year's growing season due to the urgent and non-routine
situation resulting from a lack of effective registered pesticides or
alternative practices to control onion smut in northern onion producing
States. After having reviewed the submission, EPA concurs that
emergency conditions exist for these States. EPA has authorized under
FIFRA section 18 the use of carboxin on onion seed for control of onion
smut in onions, dry bulb.
EPA assessed the potential risks presented by residues of carboxin
in or on onions, dry bulb. 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 3, 1997 (62 FR 4911). 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 onions, dry bulb 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 31, 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
[[Page 4586]]
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-300604]. 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 tolerancethat 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 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: January 14, 1998.
James Jones,
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.
2. Section 180.301 is amended by adding a heading to paragraph (a);
by revising paragraph (b); and by adding and reserving paragraphs (c)
and (d) with headings to read as follows:
Sec. 180.301 Carboxin; tolerances for residues.
(a) General. * * *
(b) Section 18 emergency exemptions. A time-limited tolerance is
established for residues of the combined residues (free and bound) of
the fungicide carboxin (5,6-dihydro-2-methyl-1,4-oxathiin-3-
carboxanilide) and its sulfoxide metabolite (5,6-dihydro-3-
carboxanilide-2-methyl-1,4-oxathiin-4-oxide), each expressed as the
parent compund in connection with use of the pesticide under section 18
emergency exemption granted by EPA. The tolerance will expire and is
revoked on the date specified in the following table:
------------------------------------------------------------------------
Parts per Expiration/
Commodity million revocation date
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Onions, dry bulb........................ 0.2 1/31/99
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(c) Tolerances with regional registrations. [Reserved]
(d) Indirect or inadvertent residues. [Reserved]
[FR Doc. 98-2212 Filed 1-29-98; 8:45 am]
BILLING CODE 6560-50-F