[Federal Register Volume 65, Number 203 (Thursday, October 19, 2000)]
[Rules and Regulations]
[Pages 62634-62637]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-26915]


-----------------------------------------------------------------------

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-301070; FRL-6749-5]
RIN 2070-AB78


Tebuconazole; Extension of Tolerances for Emergency Exemptions

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

-----------------------------------------------------------------------

SUMMARY: This regulation 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 20.0 ppm, barley straw at 20.0 ppm, hops 
at 4.0 ppm, sunflower oil at 0.4 ppm, sunflower seed at 0.2 ppm, wheat 
hay at 15.0 ppm, and wheat straw at 2.0 ppm for an additional 1-year 
period. These tolerances will expire and are revoked on December 31, 
2001. 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, hops, 
sunflowers and wheat. Section 408(l)(6) of the Federal Food, Drug, and 
Cosmetic Act 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 the Federal 
Insecticide. Fungicide, and Rodenticide Act.

DATES: This regulation is effective October 19, 2000. Objections and 
requests for hearings, identified by docket control number OPP-301070, 
must be received by EPA on or before December 18, 2000.

ADDRESSES: Written objections and hearing requests may be submitted by 
mail, in person, or by courier. Please follow the detailed instructions 
for each method as provided in Unit III. of the SUPPLEMENTARY 
INFORMATION. To ensure proper receipt by EPA, your objections and 
hearing requests must identify docket control number OPP-301070 in the 
subject line on the first page of your response.

FOR FURTHER INFORMATION CONTACT: By mail: Stephen Schaible, 
Registration Division (7505C), Office of Pesticide Programs, 
Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460; telephone number: 703 308-9362; and e-mail 
address: [email protected].

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    You may be affected by this action if you are an agricultural 
producer, food manufacturer, or pesticide manufacturer. Potentially 
affected categories and entities may include, but are not limited to:

------------------------------------------------------------------------
                                        NAICS    Examples of potentially
             Categories                 codes       affected entities
------------------------------------------------------------------------
Industry............................        111  Crop production.
                                            112  Animal production.
                                            311  Food manufacturing.
                                          32532  Pesticide
                                                  manufacturing.
------------------------------------------------------------------------

    This listing is not intended to be exhaustive, but rather provides 
a guide for readers regarding entities likely to be affected by this 
action. Other types of entities not listed in the table could also be 
affected. The North American Industrial Classification System (NAICS) 
codes have been provided to assist you and others in determining 
whether or not this action might apply to certain entities. If you have 
questions regarding the applicability of this action to a particular 
entity, consult the person listed under FOR FURTHER INFORMATION 
CONTACT.

B. How Can I Get Additional Information, Including Copies of this 
Document and Other Related Documents?

    1. Electronically. You may obtain electronic copies of this 
document, and certain other related documents that might be available 
electronically, from the EPA Internet Home Page at http://www.epa.gov/. 
To access this document, on the Home Page select ``Laws and 
Regulations,'' ``Regulations and Proposed Rules,'' and then look up the 
entry for this document under the ``Federal Register--Environmental 
Documents.'' You can also go directly to the Federal Register listing 
at http://www.epa.gov/fedrgstr/.
    2. In person. The Agency has established an official record for 
this action under docket control number OPP-301070. The official record 
consists of the documents specifically referenced in this action, and 
other information related to this action,

[[Page 62635]]

including any information claimed as Confidential Business Information 
(CBI). This official record includes the documents that are physically 
located in the docket, as well as the documents that are referenced in 
those documents. The public version of the official record does not 
include any information claimed as CBI. The public version of the 
official record, which includes printed, paper versions of any 
electronic comments submitted during an applicable comment period is 
available for inspection in the Public Information and Records 
Integrity Branch (PIRIB), Rm. 119, Crystal Mall #2, 1921 Jefferson 
Davis Hwy., Arlington, VA, from 8:30 a.m. to 4 p.m., Monday through 
Friday, excluding legal holidays. The PIRIB telephone number is (703) 
305-5805.

II. Background and Statutory Findings

    EPA issued a final rule, published in the Federal Register of June 
20, 1997 (62 FR 33550) (FRL-5725-7), which announced that on its own 
initiative under section 408 of the Federal Food, Drug, and Cosmetic 
Act (FFDCA), 21 U.S.C. 346a, as amended by the Food Quality Protection 
Act of 1996 (FQPA) (Public Law 104-170) it established time-limited 
tolerances for the residues of tebuconazole in or on barley grain at 
2.0 ppm, barley hay at 20.0 ppm, barley straw at 20.0 ppm, wheat hay at 
15.0 ppm, and wheat straw at 2.0 ppm, with an expiration date of June 
30, 1998.
    EPA issued a final rule, published in the Federal Register of 
October 29, 1997 (62 FR 56089) (FRL-5752-4), which announced that on 
its own initiative under section 408 of the Federal Food, Drug, and 
Cosmetic Act (FFDCA), 21 U.S.C. 346a, as amended by the Food Quality 
Protection Act of 1996 (FQPA) (Public Law 104-170) it established time-
limited tolerances for the residues of tebuconazole in or on sunflower 
oil and sunflower seed at 0.4 ppm and 0.2 ppm, respectively, with an 
expiration date of September 30, 1998.
    EPA issued a final rule, published in the Federal Register of 
December 2, 1998 (63 FR 66449) (FRL-6036-3), which announced that on 
its own initiative under section 408 of the Federal Food, Drug, and 
Cosmetic Act (FFDCA), 21 U.S.C. 346a, as amended by the Food Quality 
Protection Act of 1996 (FQPA) (Public Law 104-170) it established a 
time-limited tolerance for the residues of tebuconazole in or on hops 
at 4.0 ppm, with an expiration date of December 31, 2000.
    EPA established these 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 the Federal Insecticide, 
Fungicide, and Rodenticide Act (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, 
hops, sunflowers and wheat for this year's growing season due to 
continued non-routine situations for growers of these crops. Idaho, 
Oregon and Washington requested emergency exemptions to control stripe 
rust in barley, and Oregon also requested the use of tebuconazole to 
control stripe and leaf rust in wheat; currently registered 
alternatives do not allow application at a sufficiently late stage of 
growth to control the disease. Michigan, Minnesota, North Dakota and 
South Dakota requested emergency exemptions to control Fusarium head 
blight in barley and/or wheat, as the disease continues to be a problem 
for growers in those states. Buildup of rust inoculum and continued wet 
and cool weather creates a potential emergency situation for sunflower 
growers in Colorado, Kansas, Nebraska and North Dakota. Idaho, Oregon 
and Washington requested the use on hops to control powdery mildew as 
it is claimed there are no effective alternatives currently registered. 
After having reviewed these submissions, EPA concurs that emergency 
conditions exist. EPA has authorized under FIFRA section 18 the use of 
tubconazole on barley, hops, sunflowers and wheat for control of the 
above pests in the states listed above.
    EPA assessed the potential risks presented by residues of 
tebuconazole in or on barley, hops, sunflowers and wheat. In doing so, 
EPA considered the 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 safety standard and with FIFRA section 18. 
The data and other relevant material have been evaluated and discussed 
in the final rules of June 20, 1997; October 29, 1997; and December 2, 
1998. Based on those 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). Therefore, the time-
limited tolerances are extended for an additional 1-year period. EPA 
will publish a document in the Federal Register to remove the revoked 
tolerances from the Code of Federal Regulations (CFR). Although these 
tolerances will expire and are revoked on December 31, 2001, 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, hops, sunflower oil, sunflower seed, wheat 
hay, and wheat straw 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.

III. Objections and Hearing Requests

    Under section 408(g) of the FFDCA, as amended by the FQPA, any 
person may file an objection to any aspect of this regulation and may 
also request a hearing on those objections. The EPA procedural 
regulations which govern the submission of objections and requests for 
hearings appear in 40 CFR part 178. Although the procedures in those 
regulations require some modification to reflect the amendments made to 
the FFDCA by the FQPA of 1996. EPA will continue to use those 
procedures, with appropriate adjustments, until the necessary 
modifications can be made. The new section 408(g) provides essentially 
the same process for persons to ``object'' to a regulations for an 
exemption from the requirement of a tolerance issued by EPA under new 
section 408(d), as was provided in the old FFDCA sections 408 and 409. 
However, the period for filing objections is now 60 days, rather than 
30 days.

A. What Do I Need to Do To File an Objection or Request a Hearing?

    You must file your objection or request a hearing on this 
regulation in accordance with the instructions provided in this unit 
and in 40 CFR part 178. To ensure proper receipt by EPA, you must 
identify docket control number OPP-301070 in the subject line on the 
first page of your submission. All requests must be in writing, and 
must be mailed or delivered to the Hearing Clerk on or before December 
18, 2000.
    1. Filing the request. Your objection must specify the specific 
provisions in the regulation that you object to, and the grounds for 
the objections (40 CFR 178.25). If a hearing is requested, the 
objections must include a statement of the factual issue(s) on which a 
hearing is requested, the requestor's contentions on such issues, and a 
summary of any evidence relied upon by the objector (40 CFR 178.27). 
Information submitted in connection with an objection or hearing 
request may be claimed confidential by marking any part or all of that

[[Page 62636]]

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.
    Mail your written request to: Office of the Hearing Clerk (1900), 
Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460. You may also deliver your request to the Office 
of the Hearing Clerk in Rm. C400, Waterside Mall, 401 M St., SW., 
Washington, DC 20460. The Office of the Hearing Clerk is open from 8 
a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The 
telephone number for the Office of the Hearing Clerk is (202) 260-4865.
    2. Tolerance fee payment. If you file an objection or request a 
hearing, you must also pay the fee prescribed by 40 CFR 180.33(i) or 
request a waiver of that fee pursuant to 40 CFR 180.33(m). You must 
mail the fee to: EPA Headquarters Accounting Operations Branch, Office 
of Pesticide Programs, P.O. Box 360277M, Pittsburgh, PA 15251. Please 
identify the fee submission by labeling it ``Tolerance Petition Fees.''
    EPA is authorized to waive any fee requirement ``when in the 
judgment of the Administrator such a waiver or refund is equitable and 
not contrary to the purpose of this subsection.'' For additional 
information regarding the waiver of these fees, you may contact James 
Tompkins by phone at (703) 305-5697, by e-mail at [email protected], 
or by mailing a request for information to Mr. Tompkins at Registration 
Division (7505C), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460.
    If you would like to request a waiver of the tolerance objection 
fees, you must mail your request for such a waiver to: James Hollins, 
Information Resources and Services Division (7502C), Office of 
Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania 
Ave., NW., Washington, DC 20460.
    3. Copies for the Docket. In addition to filing an objection or 
hearing request with the Hearing Clerk as described in Unit III.A., you 
should also send a copy of your request to the PIRIB for its inclusion 
in the official record that is described in Unite I.B.2. Mail your 
copies, identified by docket control number OPP-301070, to: Public 
Information and Records Integrity Branch, Information Resources and 
Services Division (7502C), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460. 
In person or by courier, bring a copy to the location of the PIRIB 
described in Unit I.B.2. You may also send an electronic copy of your 
request via e-mail to: [email protected]. Please use an ASCII file 
format and avoid the use of special characters and any form of 
encryption. Copies of electronic objections and hearing requests will 
also be accepted on disks in WordPerfect 6.1/8.0 file format or ASCII 
file format. Do not include any CBI in your electronic copy. You may 
also submit an electronic copy of your request at many Federal 
Depository Libraries.

B. When Will the Agency Grant a Request for a Hearing?

    A request for a hearing will be granted if the Administrator 
determines that the material submitted shows the following: There is a 
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 issue(s) in the manner sought 
by the requestor would be adequate to justify the action requested (40 
CFR 178.32).

IV. Regulatory Assessment Requirements

    This final rule extends the expiration date of time-limited 
tolerances under FFDCA section 408. 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) (Public Law 104-4). Nor 
does it require any prior consultation as specified by Executive Order 
13084, entitled Consultation and Coordination with Indian Tribal 
Governments (63 FR 27655, May 19, 1998); 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 or 
any Agency action under Executive Order 13045, entitled Protection of 
Children from Environmental Health Risks and Safety Risks (62 FR 19885, 
April 23, 1997). This action does not involve any technical standards 
that would require Agency consideration of voluntary consensus 
standards pursuant to section 12(d) of the National Technology Transfer 
and Advancement Act of 1995 (NTTAA), Public Law 104-113, section 12(d) 
(15 U.S.C. 272 note). Since tolerances and exemptions that are 
established on the basis of a FIFRA section 18 petition under FFDCA 
section 408, such as the tolerances in this final rule, do 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. In addition, 
the Agency has determined that this action will not have a substantial 
direct effect on States, on the relationship between the national 
government and the States, or on the distribution of power and 
responsibilities among the various levels of government, as specified 
in Executive Order 13132 entitled Federalism (64 FR 43255, August 10, 
1999). Executive Order 13132 requires EPA to develop an accountable 
process to ensure ``meaningful and timely input by State and local 
officials in the development of regulatory policies that have 
federalism implications.'' ``Policies that have federalism 
implications'' is defined in the Executive Order to include regulations 
that have ``substantial direct effects on the States, on the 
relationship between the national government and the States, or on the 
distribution of power and responsibilities among the various levels of 
government.'' This final rule directly regulates growers, food 
processors, food handlers and food retailers, not States. This action 
does not alter the relationships or distribution of power and 
responsibilities established by Congress in the preemption provisions 
of FFDCA section 408(n)(4).

V. 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 final rule in the Federal Register. This final 
rule is not a ``major rule'' as defined by 5 U.S.C. 804(2).

[[Page 62637]]

List of Subjects in 40 CFR Part 180

    Environmental protection, Administrative practice and procedure, 
Agricultural commodities, Pesticides and pests, Reporting and 
recordkeeping requirements.

    Dated: October 3. 2000.
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. 321(q), (346a) and 371.


Sec. 180.474  [Amended]

    2. In Sec. 180.474, the table in paragraph (b)(1), the entries for 
``barley, grain''; ``barley, hay''; ``barley, straw''; ``hops''; 
``sunflower oil''; ``sunflower seed''; ``wheat, hay''; and ``wheat, 
straw'', revise the ``Expiration/revocation date'', ``12/31/00'' to 
read ``12/31/01.''

[FR Doc. 00-26915 Filed 10-18-00; 8:45 am]
BILLING CODE 6560-50-M