98-19405. Tebuconazole; Extension of Tolerances for Emergency Exemptions

[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: [e-mail]. 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: 
[e-mail].

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:
[e-mail].


    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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