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 [Federal Register: June 1, 2005 (Volume 70, Number 104)]
[Rules and Regulations]
[Page 31355-31359]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr01jn05-8]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-2005-0078; FRL-7714-1]

Tetraconazole; Pesticide Tolerances for Emergency Exemptions
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation establishes time-limited tolerances for
residues of tetraconazole 1-[2-(2,4-dichlorophenyl)-3-(1,1,2,2-
tetrafluoroethoxy) propyl]-1H-1,2,4-triazole in or on soybean, poultry,
and eggs. This action is in response to EPA's granting of emergency
exemptions under section 18 of the Federal Insecticide, Fungicide, and
Rodenticide Act (FIFRA) authorizing use of the pesticide on soybeans.
This regulation establishes maximum permissible levels for residues of
tetraconazole in these food commodities. The tolerances will expire and
are revoked on December 31, 2009.

[[Page 31356]]

DATES: This regulation is effective June 1, 2005. Objections and
requests for hearings must be received on or before August 1, 2005.

ADDRESSES: To submit a written objection or hearing request follow the
detailed instructions as provided in Unit VII. of the SUPPLEMENTARY
INFORMATION. EPA has established a docket for this action under docket
identification (ID) number . All documents in the docket
are listed in the EDOCKET index at http://www.epa.gov/edocket . Although
listed in the index, some information is not publicly available, i.e.,
CBI or other information whose disclosure is restricted by statute.
Certain other material, such as copyrighted material, is not placed on
the Internet and will be publicly available only in hard copy form.
Publicly available docket materials are available either electronically
in EDOCKET or in hard copy at the Public Information and Records
Integrity Branch (PIRIB), Rm. 119, Crystal Mall #2, 1801 S.
Bell St., Arlington, VA. This docket facility is open from 8:30 a.m. to
4 p.m., Monday through Friday, excluding legal holidays. The docket
telephone number is (703) 305-5805.

FOR FURTHER INFORMATION CONTACT: Andrea Conrath, Registration Division
(7505C), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone
number (703) 308-9367; e-mail address: conrath.andrea@epa.gov .

SUPPLEMENTARY INFORMATION:
I. General Information
You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
Potentially affected entities may include, but are not limited to:
• Crop production (NAICS 111)
• Animal production (NAICS 112)
• Food manufacturing (NAICS 311)
• Pesticide manufacturing (NAICS 32532)
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 this unit could also be
affected. The North American Industrial Classification System (NAICS)
codes have been provided to assist you and others in determining
whether this action might apply to certain entities.
How Can I Access Electronic Copies of this Document and Other Related
Information?
In addition to using EDOCKET ( http://www.epa.gov/edocket/ ), you may
access this Federal Register document electronically through the EPA
Internet under the ``Federal Register'' listings at http://www.epa.gov/
fedrgstr/ . A frequently updated electronic version of 40 CFR part 180
is available at E-CFR Beta Site Two at http://www.gpoaccess.gov/ecfr/ .

II. Background and Statutory Findings

EPA, on its own initiative, in accordance with sections 408(e) and
408 (l)(6) of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21
U.S.C. 346a, is establishing tolerances for residues of the fungicide
tetraconazole, [1-[2-(2,4-dichlorophenyl)-3-(1,1,2,2-tetrafluoroethoxy)
propyl]-1H-1,2,4-triazole], in or on soybean seed at 0.05 part per
million (ppm); poultry meat at 0.0003 ppm; poultry fat at 0.004 ppm;
poultry liver at 0.03 ppm; poultry meat byproducts (excluding liver) at
0.002 ppm; and egg at 0.03 ppm. These tolerances will expire and are
revoked on December 31, 2009. EPA will publish a document in the
Federal Register to remove the revoked tolerances from the Code of
Federal Regulations.

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 does not intend for its actions on
section 18 related tolerances to set binding precedents for the
application of section 408 of the FFDCA and the new safety standard to
other tolerances and exemptions. Section 408(e) of the FFDCA allows EPA
to establish a tolerance or an exemption from the requirement of a
tolerance on its own initiative, i.e., without having received any
petition from an outside party.

Section 408(b)(2)(A)(i) of the FFDCA allows EPA to establish a
tolerance (the legal limit for a pesticide chemical residue in or on a
food) only if EPA determines that the tolerance is ``safe.'' section
408(b)(2)(A)(ii) of the FFDCA defines ``safe'' to mean that ``there is
a reasonable certainty that no harm will result from aggregate exposure
to the pesticide chemical residue, including all anticipated dietary
exposures and all other exposures for which there is reliable
information.'' This includes exposure through drinking water and in
residential settings, but does not include occupational exposure.
Section 408(b)(2)(C) of the FFDCA requires EPA to give special
consideration to exposure of infants and children to the pesticide
chemical residue in establishing a tolerance and to ``ensure that there
is a reasonable certainty that no harm will result to infants and
children from aggregate exposure to the pesticide chemical residue. . .
.''
Section 18 of the FIFRA authorizes EPA to exempt any Federal or
State agency from any provision of FIFRA, if EPA determines that
``emergency conditions exist which require such exemption.'' This
provision was not amended by the Food Quality Protection Act of 1996
(FQPA). EPA has established regulations governing such emergency
exemptions in 40 CFR part 166.

III. Emergency Exemption for Tetraconazole on Soybeans and FFDCA
Tolerances

The States of Minnesota and South Dakota, as lead state agencies in
what is essentially a ``national'' section 18 request for all soybean
growing States, have petitioned the Agency requesting an emergency
exemption for tetraconazole to control soybean rust under section 18 of
the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA). On
November 10, 2004, U.S. Department of Agriculture's Animal and Plant
Health Inspection Service (USDA/APHIS) confirmed the presence of
Phakopsora pachyrhizi, the pathogen that causes soybean rust, on
soybean leaf samples taken from two plots associated with a Louisiana
State University research farm. Soybean rust has been designated as a
biosecurity threat and therefore, it is important that control measures
be available for the disease. EPA has authorized under FIFRA section 18
the use of tetraconazole on soybeans for control of soybean rust in
Minnesota, South Dakota, and all the other States that have requested
an exemption for this use. After having reviewed the submissions, EPA
concurs that emergency conditions exist for these States.

As part of its assessment of these emergency exemptions, EPA
assessed the potential risks presented by residues of tetraconazole in
or on soybean, poultry, meat and egg commodities. In doing so, EPA
considered the safety standard in section 408(b)(2) of the FFDCA, and
EPA decided that the necessary tolerances under section 408(l)(6) of
the FFDCA would be

[Page 31357]]

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 entitled ``Tetraconazole; Time-Limited Pesticide Tolerance''
published in the Federal Register of April 22, 2005 (70 FR 20821) (FRL-
7702-4). The risk assessment discussed in that document included
contribution to risk from this soybean use. Based on that data and
information considered, the Agency concludes that establishing these
time-limited tolerances will meet the requirements of section 408(l)(6)
of the FFDCA.

Consistent with the need to move quickly on the emergency exemption
in order to address an urgent non-routine situation and to ensure that
the resulting food is safe and lawful, EPA is issuing these tolerances
without notice and opportunity for public comment as provided in
section 408(l)(6) of the FFDCA. Although these tolerances will expire
and are revoked on December 31, 2009, under section 408(l)(5) of the
FFDCA, residues of the pesticide not in excess of the amounts specified
in the tolerances remaining in or on soybean, poultry, meat and egg
commodities after that date will not be unlawful, provided the
pesticide is applied in a manner that was lawful under FIFRA, and the
residues do not exceed levels that were authorized by these tolerances
at the time of that application. 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.

Because these tolerances are being approved under emergency
conditions, EPA has not made any decisions about whether tetraconazole
meets EPA's registration requirements for use on soybeans or whether
permanent tolerances for this use would be appropriate. Under these
circumstances, EPA does not believe that these tolerances serve as a
basis for registration of tetraconazole by a State for special local
needs under FIFRA section 24(c). Nor do these tolerances serve as the
basis for any State other than those which have been granted exemptions
as part of the soybean rust section 18 to use this pesticide on this
crop under section 18 of FIFRA without following all provisions of
EPA's regulations implementing FIFRA section 18 as identified in 40 CFR
part 166. For additional information regarding the emergency exemption
for tetraconazole, contact the Agency's Registration Division at the
address provided under FOR FURTHER INFORMATION CONTACT.

IV. Aggregate Risk Assessment and Determination of Safety

EPA performs a number of analyses to determine the risks from
aggregate exposure to pesticide residues. For further discussion of the
regulatory requirements of section 408 of the FFDCA and a complete
description of the risk assessment process, see the final rule on
Bifenthrin Pesticide Tolerances November 26, 1997 (62 FR 62961) (FRL-
5754-7).

Consistent with section 408(b)(2)(D) of the FFDCA, EPA has reviewed
the available scientific data and other relevant information in support
of this action. EPA has sufficient data to assess the hazards of
tetraconazole and to make a determination on aggregate exposure,
consistent with section 408(b)(2) of the FFDCA, for time-limited
tolerances for residues of tetraconazole in or on soybean seed at 0.05
ppm; poultry meat at 0.0003 ppm; poultry fat at 0.004 ppm; poultry
liver at 0.03 ppm; poultry meat byproducts at 0.002 ppm (excluding
liver); and egg at 0.03 ppm. For purposes of this section 18 petition,
parent tetraconazole is being considered. The Agency does have concern
about potential toxicity of 1,2,4-triazole and two conjugates,
triazolylalanine and triazolyl acetic acid. These three compounds are
metabolites to most of the triazole-containing fungicides. To support
the extension of existing parent triazole-derivative fungicide
tolerances, EPA conducted an interim human health assessment for
aggregate exposure to 1,2,4-triazole. The exposure and risk estimates
presented in this assessment are overestimates of actual likely
exposures and therefore, should be considered to be highly
conservative. Based on this assessment EPA concluded that for all
exposure durations and population subgroups, aggregate exposures to
1,2,4-triazole are not expected to exceed its level of concern. This
assessment should be considered interim due to the ongoing series of
studies being conducted by the U.S. Triazole Task Force (USTTF). Those
studies are designed to provide the Agency with more complete
toxicological and residue information for free triazole and are
expected to be submitted to the Agency in late 2004. Upon completion of
the review of these data, EPA will prepare a more sophisticated
assessment based on the revised toxicological and exposure databases.
The most recent estimated aggregate risks resulting from the use of
tetraconazole, are discussed in the Federal Register of April 22, 2005
(70 FR 20821) (FRL-7702-4), final rule establishing tolerances for
residues of tetraconazole in/on sugarbeet and livestock commodities. In
that prior action, risk was estimated assuming tolerance level residues
in all commodities for established and proposed tolerances, including
the tolerances for soybean and animal commodities discussed in this
document. Therefore, establishing these tolerances will not change the
most recent estimated aggregate risks resulting from use of
tetraconazole, as discussed in the April 22, 2005 Federal Register
document. Refer to the April 22, 2005 Federal Register document for a
detailed discussion of the aggregate risk assessments and determination
of safety. EPA relies upon that risk assessment and the findings made
in that Federal Register document in support of this action.

Available residue data indicate that the use pattern for the
emergency exemptions for soybean will not result in residues of
tetraconazole over the following levels: Soybean seed at 0.05 ppm;
poultry meat at 0.0003 ppm; poultry fat at 0.004 ppm; poultry liver at
0.03 ppm; poultry meat byproducts (excluding liver) at 0.002 ppm; and
egg at 0.03 ppm. Therefore, tolerances are being established for these
commodities at these levels. Based on the risk assessments discussed in
the final rule published in the Federal Register of April 22, 2005, EPA
concludes that there is a reasonable certainty that no harm will result
to the general population and to infants and children from aggregate
exposure to tetraconazole residues.

V. Other Considerations

A. Analytical Enforcement Methodology

Adequate enforcement methodology (capillary gas chromatography with
electron capture detector (GC/ECD)) is available to enforce the
tolerance expression. The method may be requested from: Chief,
Analytical Chemistry Branch, Environmental Science Center, 701 Mapes
Rd., Ft. Meade, MD 20755-5350; telephone number: (410) 305-2905; e-mail
address: residue methods@epa.gov.

B. International Residue Limits

There are no established Codex, Canadian, or Mexican Maximum
Residue Limits established for tetraconazole.

VI. Conclusion

Therefore, the tolerances are established for residues of
tetraconazole, 1-[2-(2,4-dichlorophenyl)-3-(1,1,2,2-

[[Page 31358]]

tetrafluoroethoxy) propyl]-1H-1,2,4-triazole, in or on soybean, seed at
0.05 ppm; poultry, meat at 0.0003 ppm; poultry, fat at 0.004 ppm;
poultry, liver at 0.03 ppm; poultry, meat byproducts, except liver at
0.002 ppm; and egg at 0.03 ppm.

VII. 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, EPA will continue to use those procedures, with
appropriate adjustments, until the necessary modifications can be made.
The new section 408(g) of the FFDCA 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)
of the FFDCA, as was provided in the old sections 408 and 409 of the
FFDCA. 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 ID number OPP-2005-0078 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 August 1,
2005.

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
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 (1900L),
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460-0001. You may also deliver your request to the
Office of the Hearing Clerk in Suite 350, 1099 14th St., NW.,
Washington, DC 20005. 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) 564-6255.

2. Copies for the Docket. In addition to filing an objection or
hearing request with the Hearing Clerk as described in Unit VII.A., you
should also send a copy of your request to the PIRIB for its inclusion
in the official record that is described in ADDRESSES. Mail your
copies, identified by the docket ID number OPP-2005-0078, 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-
0001. In person or by courier, bring a copy to the location of the
PIRIB described in ADDRESSES. You may also send an electronic copy of
your request via e-mail to: opp-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 6.1/8.0 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).

VIII. Statutory and Executive Order Reviews

This final rule establishes time-limited tolerances under section
408 of the FFDCA. 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). Because this rule has been exempted from review under Executive
Order 12866 due to its lack of significance, this rule is not subject
to Executive Order 13211, Actions Concerning Regulations That
Significantly Affect Energy Supply, Distribution, or Use (66 FR 28355,
May 22, 2001). 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 special considerations 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 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 exemption under section 408 of the FFDCA, 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. The Agency hereby certifies that
this rule will not have significant negative economic impact on a
substantial number of small entities. 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

[[Page 31359]]

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 section 408(n)(4) of the
FFDCA. For these same reasons, the Agency has determined that this rule
does not have any ``tribal implications'' as described in Executive
Order 13175, entitled Consultation and Coordination with Indian Tribal
Governments (59 FR 22951, November 6, 2000). Executive Order 13175,
requires EPA to develop an accountable process to ensure ``meaningful
and timely input by tribal officials in the development of regulatory
policies that have tribal implications.'' ``Policies that have tribal
implications'' is defined in the Executive Order to include regulations
that have ``substantial direct effects on one or more Indian tribes, on
the relationship between the Federal Government and the Indian tribes,
or on the distribution of power and responsibilities between the
Federal Government and Indian tribes.'' This rule will not have
substantial direct effects on tribal governments, on the relationship
between the Federal Government and Indian tribes, or on the
distribution of power and responsibilities between the Federal
Government and Indian tribes, as specified in Executive Order 13175.
Thus, Executive Order 13175 does not apply to this rule.

IX. Congressional Review Act

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).

List of Subjects in 40 CFR Part 180

Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.
Dated: May 12, 2005.
Lois Rossi,
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.
• 2. Section 180.557 is amended by adding text to paragraph (b) to read
as follows:
Sec. 180.557 Tetraconazole; tolerances for residues.
(a) * * *
(b) Section 18 emergency exemptions. Time-limited tolerances are
established for residues of the fungicide tetraconazole 1-[2-(2,4-
dichlorophenyl)-3-(1,1,2,2-tetrafluoroethoxy) propyl]-1H-1,2,4-triazole
in connection with use of the pesticide under section 18 emergency
exemptions granted by EPA. These tolerances will expire and are revoked
on the dates specified in the following table:

* * * * *
[FR Doc. 05-10765 Filed 5-31-05; 8:45 am]
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