[Federal Register Volume 64, Number 183 (Wednesday, September 22, 1999)]
[Rules and Regulations]
[Pages 51248-51251]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-24693]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-300919; FRL-6381-6]
RIN 2070-AB78
Tebuconazole; Extension of Tolerances for Emergency Exemptions
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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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 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 combined residues of tebuconazole
and its metabolite in milk at 0.1 ppm and in meat byproducts of cattle,
goats, hogs, horses, poultry and sheep at 0.2 ppm for an additional 1-
year period. These tolerances will expire and are revoked on December
31, 2000. 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 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 September 22, 1999. Objections and
requests for hearings, identified by docket control number OPP-300919,
must be received by EPA on or before November 22, 1999.
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'' section. To ensure proper receipt by EPA, your objections
and hearing requests must identify docket control number OPP-300919 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, 401 M St., SW., Washington, DC 20460;
telephone number: (703) 308-9362; and e-mail address:
schaible.stephen@epa.gov.
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:
------------------------------------------------------------------------
Examples of
Categories NAICS Potentially
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 in the ``FOR FURTHER INFORMATION
CONTACT'' section.
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
[[Page 51249]]
the EPA Internet Home Page at http://www.epa.gov/. To access this
document, on the Home Page select ``Laws and Regulations'' and then
look up the entry for this document under the ``Federal Register--
Environmental Documents.'' You can also go directly to the Federal
Register listings at http://www.epa.gov/fedrgstr/.
2. In person. The Agency has established an official record for
this action under docket control number OPP-300919. The official record
consists of the documents specifically referenced in this action, and
other information related to this action, 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 ppm, barley straw at 20 ppm, wheat hay at 15
ppm, wheat straw at 2.0 ppm, and pistachios at 1.0 ppm. EPA also
established time-limited tolerances for the combined residues of
tebuconazole and its metabolite (HGW-2061) in milk at 0.1 ppm and in
meat byproducts of cattle, goats, hogs, horses, poultry and sheep at
0.2 ppm. All of these tolerances had an expiration date of June 30,
1998. The expiration date of these tolerances was extended to December
31, 1999, in a final rule published in the Federal Register on July 21,
1998 (63 FR 39032) (FRL-6015-9). 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,
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 and panicle/shoot 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 these
submissions, EPA concurs that emergency conditions exist. EPA has
authorized under FIFRA section 18 the use of tebuconazole on barley,
wheat and pistachios for control of the above fungal diseases.
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
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 rule
of June 20, 1997 (62 FR 33550). 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).
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, 2000, 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.
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 regulation 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-300919 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 November
22, 1999.
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 issues(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
[[Page 51250]]
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.
Mail your written request to: Office of the Hearing Clerk (1900),
Environmental Protection Agency, 401 M St., SW., Washington, DC 20460.
You may also deliver your request to the Office of the Hearing Clerk in
Room M3708, 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
judgement 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 tompkins.jim@epa.gov,
or by mailing a request for information to Mr. Tompkins at Registration
Division (7505C), Office of Pesticide Programs, Environmental
Protection Agency, 401 M St., SW., 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, 401 M St., SW.,
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. of
this preamble, you should also send a copy of your request to the PIRIB
for its inclusion in the official record that is described in Unit
I.B.2. of this preamble. Mail your copies, identified by docket number
OPP-300919 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 or by courier, bring a copy to the
location of the PIRIB described in Unit I.B.2. of this preamble. You
may also send an electronic copy of your request via e-mail to: docket@epa.gov. 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 5.1/6.1 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 issues(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 establishes exemptions from the tolerance
requirement under section 408(d) of the FFDCA 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). 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 prior
consultation with State, local, and tribal government officials as
specified by Executive Order 12875, entitled Enhancing the
Intergovernmental Partnership (58 FR 58093, October 28, 1993) and
Executive Order 13084, entitled Consultation and Coordination with
Indian Tribal Governments (63 FR 27655, May 19, 1998), or special
consideration of environmental justice related issues under 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). 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 12612,
entitled Federalism (52 FR 41685, October 30, 1987). This action
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 the Federal Food, Drug, and Cosmetic Act,
21 U.S.C. 346a(b)(4).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). In addition, since
tolerances and exemptions that are established on the basis of a
petition under FFDCA section 408(d), such as the exemption 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.
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 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
[[Page 51251]]
and pests, Reporting and recordkeeping requirements.
Dated: September 9, 1999.
Peter Caulkins,
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. 321(q), 346(a) and 371.
Sec. 180.474 [Amended]
2. In Sec. 180.474, by amending paragraph (b) by changing the date
``12/31/99'' to read ``12/31/00''.
[FR Doc. 99-24693 Filed 9-21-99; 8:45 am]
BILLING CODE 6560-50-F
