[Federal Register Volume 70, Number 104 (Wednesday, June 1, 2005)]
[Rules and Regulations]
[Pages 31355-31359]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-10765]


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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 OPP-2005-0078. 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: [email protected].

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 [email protected].

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: [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 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 (65 FR 67249, 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.

0
Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

0
1. The authority citation for part 180 continues to read as follows:

    Authority: 21 U.S.C. 321(q), 346a and 371.


0
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:

------------------------------------------------------------------------
                                           Parts per      Expiration/
                Commodity                   million     revocation date
------------------------------------------------------------------------
Egg.....................................         0.03           12/31/09
Poultry, fat............................        0.004           12/31/09
Poultry, liver..........................         0.03           12/31/09
Poultry, meat...........................       0.0003           12/31/09
Poultry, meat byproduct, except liver...        0.002           12/31/09
Soybean, seed...........................         0.05           12/31/09
------------------------------------------------------------------------

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[FR Doc. 05-10765 Filed 5-31-05; 8:45 am]
BILLING CODE 6560-50-S