[Federal Register Volume 63, Number 139 (Tuesday, July 21, 1998)]
[Rules and Regulations]
[Pages 39032-39034]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-19405]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-300679; FRL-6015-9]
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 in or on barley grain at 2.0 parts per million
(ppm), barley hay at 20 ppm, barley straw at 20 ppm, wheat hay at 15
ppm, wheat straw at 2.0 ppm, and pistachios at 1.0 ppm; and extends
time-limited tolerances for the combined residues of tebuconazole and
its metabolite (HGW 2061) in milk at 0.1 ppm and meat byproducts of
cattle, goats, hogs, horses, poultry and sheep at 0.2 ppm for an
additional 18-month period, to December 31, 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 barley, wheat, and pistachios. 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 July 21, 1998. Objections and
requests for hearings must be received by EPA, on or before September
21, 1998.
ADDRESSES: Written objections and hearing requests, identified by the
docket control number, [OPP-300679], 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-300679], 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 June 20, 1997 (FRL-5725-7) , 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 time-limited tolerances for the
residues of tebuconazole in or on barley grain at 2.0 ppm, barley hay
at 20 ppm, barley straw at 20 ppm, wheat hay at 15 ppm, wheat straw at
2.0 ppm, and pistachios at 1.0 ppm. EPA established time-limited
tolerances for the combined residues of tebuconazole and its 1-(4-
chlorophenyl)-4,4-dimethyl-3-(1H-1,2,4-triazole-1-yl-methyl)-pentane-
3,5-diol metabolite (HGW 2061) in milk at 0.1 ppm and meat byproducts
of cattle, goats, hogs, horses, poultry and sheep at 0.2 ppm. All of
these tolerances have an expiration date of June 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 requests to extend the use of tebuconazole on barley,
wheat, and pistachios for this year's growing season due to continued
non-routine situations for growers of these crops. Numerous States have
requested emergency exemptions to control rust in barley and wheat;
currently registered alternatives do not allow application at a
sufficiently late stage of growth to control the disease. Additionally,
North Dakota, Minnesota, South Dakota and Michigan have again requested
use of this chemical to control Fusarium head blight on barley and/or
wheat; abundant inoculum and wet weather conditions this year are
likely to result in a severe outbreak without the requested use. The
continued lack of an effective alternative to control late blight on
pistachios when disease pressure is high is likely to result in
significant economic losses to growers in California if wet weather
conditions occur. After having reviewed the submissions, EPA concurs
that emergency conditions exist for these States. EPA has authorized
under FIFRA section 18 the use of tebuconazole on barley, wheat, and
pistachios for control of the above fungal diseases in barley, wheat,
and pistachios.
EPA assessed the potential risks presented by residues of
tebuconazole in or on barley grain, barley hay, barley straw, wheat
hay, wheat straw, pistachios, milk, and meat byproducts of cattle,
goats, hogs, horses, poultry and sheep. 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 FIFRA section 18. The data and
other relevant material have been evaluated and discussed in the final
rule of June 20, 1997. 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).
[[Page 39033]]
Therefore, the time-limited tolerances are extended for an additional
18-month period. Although these tolerances will expire and are revoked
on December 31, 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 barley grain, barley hay, barley straw, wheat hay,
wheat straw, pistachios, milk, and meat byproducts of cattle, goats,
hogs, horses, poultry and sheep 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
tolerances. EPA will take action to revoke these tolerances 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 September 21, 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-300679]. 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
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).
[[Page 39034]]
List of Subjects in 40 CFR Part 180
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.
Dated: June 29, 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. 180.474 [Amended]
2. In Sec. 180.474, by amending paragraphs (b)(1) and (b)(2) in the
tables, by changing the date ``June 30, 1998'' to read ``12/31/99''.
[FR Doc. 98-19405 Filed 7-20-98; 8:45 am]
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