[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: 
[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:

 
------------------------------------------------------------------------
                                                          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 [email protected], 
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: opp-
[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 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