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http://www.epa.gov/fedrgstr/EPA-PEST/2005/November/Day-09/p22254.htm 

[Federal Register: November 9, 2005 (Volume 70, Number 216)]
[Rules and Regulations]
[Page 67910-67915]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr09no05-7]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-2005-0254; FRL-7740-8]

Flucarbazone-sodium; Time-Limited Pesticide Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation establishes a time-limited tolerance for
combined residues of flucarbazone-sodium, 4,5-dihydro-3-methoxy-4-
methyl-5-oxo-N-[2(trifluoromethoxy)phenyl] sulfonyl-1H-1,2,4-triazole
1-carboxamide, sodium salt and its N-desmethyl metabolite in or on
wheat, forage at 0.30 parts per million (ppm); wheat, grain at 0.01
ppm; wheat, hay at 0.10 ppm; and wheat, straw at 0.05 ppm; and combined
residues of flucarbazone-sodium and its metabolites converted to 2-
(trifluoromethoxy) benzene sulfonamide and calculated as flucarbazone-
sodium in or on milk at 0.005 ppm; meat and meat byproducts (excluding
liver) of cattle, goats, hogs, horses, and sheep at 0.01 ppm; and liver
of cattle, goats, hogs, horses, and sheep at 1.5 ppm. Arysta
LifeScience North America Corporation requested this tolerance under
the Federal Food, Drug, and Cosmetic Act (FFDCA), as amended by the
Food Quality Protection Act of 1996 (FQPA). The tolerance will expire
on November 30, 2006.

DATES: This regulation is effective November 9, 2005. Objections and
requests for hearings must be received on or before January 9, 2006.
ADDRESSES: To submit a written objection or hearing request follow the
detailed instructions as provided in

[[Page 67911]]

Unit VI. of the SUPPLEMENTARY INFORMATION. EPA has established a docket
for this action under Docket identification (ID) number OPP-2005-0254.
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: Jim Tompkins, Registration Division
(7505C), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone
number: (703) 305-5697; e-mail address: Tompkins.Jim@epa.gov .

SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this Action Apply to Me?
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 code 111)
• Animal production (NAICS code 112)
• Food manufacturing (NAICS code 311)
• Pesticide manufacturing (NAICS code 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. To determine
whether you or your business may be affected by this action, you should
carefully examine the applicability provisions in http://docket.epa.gov/
edkpub/index.jsp . If you have any questions regarding
the applicability of this action to a particular entity, consult the
person listed under FOR FURTHER INFORMATION CONTACT.

B. 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/ .
To access the OPPTS Harmonized Guidelines referenced in this
document, go directly to the guidelines at http://www.epa.gov/opptsfrs/home/guidelin.htm.
II. Background and Statutory Findings
In the Federal Register of September 29, 2000 (65 FR 58364) (FRL-
6745-9), EPA issued a time-limited tolerance for combined residues of
the herbicide, flucarbazone-sodium, 4,5-dihydro-3-methoxy-4-methyl-5-
oxo-N-[2(trifluoromethoxy)phenyl] sulfonyl-1H-1,2,4-triazole 1-
carboxamide, sodium salt and its N-desmethyl metabolite in or on wheat,
forage at 0.30 ppm; wheat, grain at 0.01 ppm; wheat, hay at 0.10 ppm;
and wheat, straw at 0.05 ppm; and combined residues of flucarbazone-
sodium and its metabolites converted to 2-(trifluoromethoxy) benzene
sulfonamide and calculated as flucarbazone-sodium in or on milk at
0.005 ppm; meat and meat byproducts (excluding liver) of cattle, goats,
hogs, horses, and sheep at 0.01 ppm; and liver of cattle, goats, hogs,
horses, and sheep at 1.5 ppm. The tolerance will expire on November 1,
2005.
In the Federal Register of July 27, 2005 (70 FR 43412) (FRL-7727-
2), EPA issued a notice pursuant to section 408(d)(3) of the FFDCA, 21
U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP
5F6949) by Arysta LifeScience North America Corporation, 100 First
Street, Suite 1700, San Francisco, CA 94105. The petition requested
that 40 CFR 180.562 be amended by establishing a tolerance for combined
residues of the herbicide, flucarbazone-sodium, 4,5-dihydro-3-methoxy-
4-methyl-5-oxo-N-[2(trifluoromethoxy)phenyl] sulfonyl-1H-1,2,4-triazole
1-carboxamide, sodium salt and its N-desmethyl metabolite in or on
wheat, forage at 0.30 ppm; wheat, grain at 0.01 ppm; wheat, hay at 0.10
ppm; and wheat, straw at 0.05 ppm; and combined residues of
flucarbazone-sodium and its metabolites converted to 2-
(trifluoromethoxy) benzene sulfonamide and calculated as flucarbazone-
sodium in or on milk at 0.005 ppm; meat and meat byproducts (excluding
liver) of cattle, goats, hogs, horses, and sheep at 0.01 ppm; and liver
of cattle, goats, hogs, horses, and sheep at 1.5 ppm. This notice
included a summary of the petition prepared by Arysta LifeScience North
America Corporation, the registrant. Comments were received on the
notice of filing. EPA response to those comments is discussed in Unit IV.D.
The time limited-tolerance previously issued September 29, 2000 (65
FR 58364) (FRL-6745-9), will be extended for 13 months and will expire
on November 30, 2006. A time-limited tolerance will be issued due to
outstanding studies (independent laboratory validations of: Analytical
Method for the Determination O-Desmethyl MKH 6562 (Metabolite of MKH
6562 in Soil by High Performance Liquid Chromatography Tandem Mass
Spectrometry), Analytical Method for the Determination of MKH 6562 and
Metabolites NODT (N,O-dimethyltriazolinone), Sulfonic Acid and
Sulfonamide in Soil by High Performance Liquid Chromatography Tandem
Mass Spectrometry, and Analytical Method for the Determination of MKH
6562 and Three Metabolites in Groundwater by High Performance Liquid
Chromatography Tandem Mass Spectrometry) will be submitted to the
Agency by the registrant in January 2006.
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. . . .''
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

[[Page 67912]]

the risk assessment process, see http://docket.epa.gov/edkpub/index.jsp.

III. Aggregate Risk Assessment and Determination of Safety
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 and to
make a determination on aggregate exposure, consistent with section
408(b)(2) of the FFDCA, for a tolerance for combined residues of
flucarbazone-sodium, 4,5-dihydro-3-methoxy-4-methyl-5-oxo-N-
[2(trifluoromethoxy)phenyl] sulfonyl-1H-1,2,4-triazole 1-carboxamide,
sodium salt and its N-desmethyl metabolite in or on wheat, forage at
0.30 ppm; wheat, grain at 0.01 ppm; wheat, hay at 0.10 ppm; and wheat,
straw at 0.05 ppm; and combined residues of flucarbazone-sodium and its
metabolites converted to 2-(trifluoromethoxy) benzene sulfonamide and
calculated as flucarbazone-sodium in or on milk at 0.005 ppm; meat and
meat byproducts (excluding liver) of cattle, goats, hogs, horses, and
sheep at 0.01 ppm; and liver of cattle, goats, hogs, horses, and sheep
at 1.5 ppm. EPA's assessment of exposures and risks associated with
establishing the tolerance follows.

A. Toxicological Profile
EPA has evaluated the available toxicity data and considered its
validity, completeness, and reliability as well as the relationship of
the results of the studies to human risk. EPA has also considered
available information concerning the variability of the sensitivities
of major identifiable subgroups of consumers, including infants and
children. Specific information on the studies received and the nature
of the toxic effects caused by flucarbazone-sodium as well as the no
observed adverse effect level (NOAEL) and the lowest observed adverse
effect level (LOAEL) from the toxicity studies can be found at http://docket.epa.gov/edkpub/index.jsp.

B. Toxicological Endpoints
For hazards that have a threshold below which there is no
appreciable risk, the dose at which no adverse effects are observed
(the NOAEL) from the toxicology study identified as appropriate for use
in risk assessment is used to estimate the toxicological level of
concern (LOC). However, the lowest dose at which adverse effects of
concern are identified (the LOAEL) is sometimes used for risk
assessment if no NOAEL was achieved in the toxicology study selected.
An uncertainty factor (UF) is applied to reflect uncertainties inherent
in the extrapolation from laboratory animal data to humans and in the
variations in sensitivity among members of the human population as well
as other unknowns.
The linear default risk methodology (Q*) is the primary method
currently used by the Agency to quantify non-threshold hazards such as
cancer. The Q* approach assumes that any amount of exposure will lead
to some degree of cancer risk, estimates risk in terms of the
probability of occurrence of additional cancer cases. More information
can be found on the general principles EPA uses in risk
characterization at http://docket.epa.gov/edkpub/index.jsp.
A summary of the toxicological endpoints for flucarbazone-sodium
used for human risk assessment is discussed in Unit III.B. of the final
rule published in the Federal Register of September 29, 2000 (65 FR 58363)
(FRL-6745-9).

C. Exposure Assessment

1. Dietary exposure from food and feed uses. Tolerances have been
established 40 CFR 180.562 for the combined residues of flucarbazone-
sodium, in or on wheat, forage at 0.30 ppm; wheat, grain at 0.01 ppm;
wheat, hay at 0.10 ppm; and wheat, straw at 0.05 ppm; and combined
residues of flucarbazone-sodium and its metabolites converted to 2-
(trifluoromethoxy) benzene sulfonamide and calculated as flucarbazone-
sodium in or on milk at 0.005 ppm; meat and meat byproducts (excluding
liver) of cattle, goats, hogs, horses, and sheep at 0.01 ppm; and liver
of cattle, goats, hogs, horses, and sheep at 1.5 ppm. Risk assessments
were conducted by EPA to assess dietary exposures from flucarbazone-
sodium in food as follows:

i. Acute exposure. Quantitative acute dietary exposure and risk
assessments are performed for a food-use pesticide if a toxicological
study has indicated the possibility of an effect of concern occurring
as a result of a one day or single exposure. The Dietary Exposure
Evaluation Model (DEEM\TM\) analysis evaluated the individual food
consumption as reported by respondents in the United States Department
of Agriculture (USDA) 1989-1992 Nationwide Continuing Surveys of Food
Intake by Individuals (CSFII) and accumulated exposure to the chemical
for each commodity.
A summary of the acute dietary exposure assessment is discussed in
Unit III.C. of the final rule published in the Federal Register of
September 29, 2000 (65 FR 58363).

ii. Chronic exposure. In conducting this chronic dietary exposure
and risk assessment the DEEM\TM\ analysis evaluated the individual food
consumption as reported by respondents in the USDA 1989-1992 Nationwide
CSFII and accumulated exposure to the chemical for each commodity.
A summary of the chronic dietary exposure assessment is discussed
in Unit III.C. of the final rule published in the Federal Register of
September 29, 2000 (65 FR 58363).

iii. Cancer. A summary of the dietary exposure assessment is
discussed in Unit III.C. of the final rule published in the Federal
Register of September 29, 2000 (65 FR 58363).
Section 408(b)(2)(E) of the FFDCA authorizes EPA to use available
data and information on the anticipated residue levels of pesticide
residues in food and the actual levels of pesticide chemicals that have
been measured in food. If EPA relies on such information, EPA must
require that data be provided 5 years after the tolerance is
established, modified, or left in effect, demonstrating that the levels
in food are not above the levels anticipated. Following the initial
data submission, EPA is authorized to require similar data on a time
frame it deems appropriate. As required by section 408(b)(2)(E) of the
FFDCA, EPA will issue a Data Call-In for information relating to
anticipated residues to be submitted no later than 5 years from the
date of issuance of this tolerance.

2. Dietary exposure from drinking water. The Agency lacks
sufficient monitoring exposure data to complete a comprehensive dietary
exposure analysis and risk assessment for flucarbazone-sodium in
drinking water. Because the Agency does not have comprehensive
monitoring data, drinking water concentration estimates are made by
reliance on simulation or modeling taking into account data on the
physical characteristics of flucarbazone-sodium. Further information
regarding EPA drinking water models used in pesticide exposure
assessment can be found at http://docket.epa.gov/edkpub/index.jsp.
A summary of the dietary exposure from drinking water assessment is
discussed in Unit III. C. of the final rule published in the Federal
Register of September 29, 2000 (65 FR 58363).
Based on the generic expected environmental concentration (GENEEC)
and screening concentration in ground water (SCI-GROW) models, the
estimated environmental concentrations (EECs) of flucarbazone-sodium
for acute exposures are estimated to be 1.42 parts per billion (ppb)
for surface water and

[[Page 67913]]

0.2 ppb for ground water. The EECs for chronic exposures are estimated
to be 1.25 ppb for surface water and 0.2 ppb for ground water.
3. From non-dietary exposure. The term ``residential exposure'' is
used in this document to refer to non-occupational, non-dietary
exposure (e.g., for lawn and garden pest control, indoor pest control,
termiticides, and flea and tick control on pets).
Flucarbazone-sodium is not registered for use on any sites that
would result in residential exposure.

4. Cumulative effects from substances with a common mechanism of
toxicity. Section 408(b)(2)(D)(v) of the FFDCA requires that, when
considering whether to establish, modify, or revoke a tolerance, the
Agency consider ``available information'' concerning the cumulative
effects of a particular pesticide's residues and ``other substances
that have a common mechanism of toxicity.''
Unlike other pesticides for which EPA has followed a cumulative
risk approach based on a common mechanism of toxicity, EPA has not made
a common mechanism of toxicity finding as to flucarbazone-sodium and
any other substances and flucarbazone-sodium does not appear to produce
a toxic metabolite produced by other substances. For the purposes of
this tolerance action, therefore, EPA has not assumed that
flucarbazone-sodium has a common mechanism of toxicity with other
substances. For information regarding EPA's efforts to determine which
chemicals have a common mechanism of toxicity and to evaluate the
cumulative effects of such chemicals, see the policy statements
released by EPA's Office of Pesticide Programs concerning common
mechanism determinations and procedures for cumulating effects from
substances found to have a common mechanism on EPA's website at http://www.epa.gov/pesticides/cumulative/.

D. Safety Factor for Infants and Children
1. In general. Section 408 of the FFDCA provides that EPA shall
apply an additional tenfold margin of safety for infants and children
in the case of threshold effects to account for prenatal and postnatal
toxicity and the completeness of the data base on toxicity and exposure
unless EPA determines that a different margin of safety will be safe
for infants and children. Margins of safety are incorporated into EPA
risk assessments either directly through use of a margin of exposure
(MOE) analysis or through using uncertainty (safety) factors in
calculating a dose level that poses no appreciable risk to humans.

2. Prenatal and postnatal sensitivity. A summary of the prenatal
and postnatal sensitivity assessment is discussed in Unit III.D. of the
final rule published in the Federal Register of September 29, 2000
(65 FR 58363).
3. Conclusion. There is a complete toxicity data base for
flucarbazone-sodium and exposure data are complete or are estimated
based on data that reasonably accounts for potential exposures. A
summary of the safety factor is discussed in Unit III.D. of the final
rule published in the Federal Register of September 29, 2000 (65 FR 58363).

E. Aggregate Risks and Determination of Safety
1. Acute risk. A summary of the acute risk assessment is discussed
in Unit III.E. of the final rule published in the Federal Register of
September 29, 2000 (65 FR 58363).
2. Chronic risk. A summary of the chronic risk assessment is
discussed in Unit III.E. of the final rule published in the Federal
Register of September 29, 2000 (65 FR 58363).
3. Short-term risk. A summary of the short-term risk assessment is
discussed in Unit III.E. of the final rule published in the Federal
Register of September 29, 2000 (65 FR 58363).
4. Intermediate-term risk. A summary of the intermediate-term risk
assessment is discussed in Unit III.E. of the final rule published in
the Federal Register of September 29, 2000 (65 FR 58363).
5. Aggregate cancer risk for U.S. population. A summary of the
aggregate cancer risk for U.S. population assessment is discussed in
Unit III.E. of the final rule published in the Federal Register of
September 29, 2000 (65 FR 58363).
6. Determination of safety. Based on these risk assessments, 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 flucarbazone-sodium residues.

IV. Other Considerations
A. Analytical Enforcement Methodology
The petitioner has proposed residue analytical methods for
tolerance enforcement in wheat and livestock commodities. The
analytical enforcement method for wheat employs accelerated solvent
extraction, clean-up using solid phase extraction columns followed by
detection and quantitation by liquid chromatography/tandem mass
spectroscopy (LC/MS/MS). The analytical method for livestock
commodities is a common moiety method which measures residues of
flucarbazone-sodium (MKH6562) in animal tissues and milk by extracting
and hydrolyzing MKH 6562 and MKH 6562-related residues to MKH 6562
sulfonamide. Detection is achieved using negative ion electrospray mass
spectrometry using deuterated MKH 6562 sulfonamide as an internal
standard. Both methods have undergone successful validations by
independent laboratories and have been accepted by the Agency. The
analytical standards for these methods are available from: Chief,
Analytical Chemistry Branch, Environmental Science Center, 701 Mapes
Rd., Ft. Meade, MD 20755-5350; telephone number: (410) 305-2905; e-mail
address: residuemethods@epa.gov.

B. International Residue Limits
A default Maximum Residue Limit (MRL) of 0.01 ppm has been
established in Canada for residues of flucarbazone-sodium and its N-
desmethyl metabolite on wheat grain. This value is consistent with the
tolerance being established in the United States on wheat grain. There
are no Codex MRLs for this compound on wheat. Therefore, no
compatibility issues exist with Codex in regard to the U.S. tolerances
discussed in this review.

C. Conditions
None.

D. Comments
Public comments were received from B. Sachau who objected to the
proposed tolerances because of the supposed harmful effects to the
human genes. B. Sachau's comments contained no scientific data or
evidence to rebut the Agency's conclusion that there is a reasonable
certainty that no harm will result from aggregate exposure to
flucarbazone-sodium including all anticipated dietary exposures and all
other exposures for which there is reliable information. EPA has
responded to B. Sachau's generalized comments on numerous previous
occasions. 70 FR 1349, 1354 (January 7, 2005); 69 FR 63083, 63096
(October 29, 2004).

V. Conclusion
Therefore, the time-limited tolerance (expires November 30, 2006)
is established for combined residues of flucarbazone-sodium, 4,5-
dihydro-3-methoxy-4-methyl-5-oxo-N-[2(trifluoromethoxy)phenyl]
sulfonyl-1H-1,2,4-triazole 1-carboxamide, sodium salt and its N-
desmethyl metabolite, in or on wheat, forage at 0.30 ppm; wheat, grain
at 0.01 ppm; wheat, hay at 0.10 ppm; and wheat,
[[Page 67914]]
straw at 0.05 ppm; and combined residues of flucarbazone-sodium and its
metabolites converted to 2-(trifluoromethoxy) benzene sulfonamide and
calculated as flucarbazone-sodium in or on milk at 0.005 ppm; meat and
meat byproducts (excluding liver) of cattle, goats, hogs, horses, and
sheep at 0.01 ppm; and liver of cattle, goats, hogs, horses, and sheep
at 1.5ppm.
VI. 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),
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-2005-0254 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 January
9, 2006.
1. Filing the request. Your objection must specify the specific
provisions in the regulation that you object to, and the grounds for
the objections (40 CFR 178.25). If a hearing is requested, the
objections must include a statement of the factual issue(s) on which a
hearing is requested, the requestor's contentions on such issues, and a
summary of any evidence relied upon by the objector (40 CFR 178.27).
Information submitted in connection with an objection or hearing
request may be claimed confidential by marking any part or all of that
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 VI.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 docket ID number OPP-2005-0254, to: Public
Information and Records Integrity Branch, Information Technology and
Resources Management 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 issue(s) in the manner sought
by the requestor would be adequate to justify the action requested (40
CFR 178.32).
VII. Statutory and Executive Order Reviews
This final rule establishes a tolerance 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). 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
petition under section 408(d) of the FFDCA, such as the tolerance 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
[[Page 67915]]
regulatory policies that have federalism implications.'' ``Policies
that have federalism implications'' is defined in the Executive Order
to include regulations that have ``substantial direct effects on the
States, on the relationship between the national government and the
States, or on the distribution of power and responsibilities among the
various levels of government.'' This final rule directly regulates
growers, food processors, food handlers and food retailers, not States.
This action does not alter the relationships or distribution of power
and responsibilities established by Congress in the preemption
provisions of 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.
VIII. Congressional Review Act
The Congressional Review Act, 5 U.S.C. 801et 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: October 28, 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 180.562 is revised to read as follows:

(b) Section 18 emergency exemptions. [Reserved]
(c) Tolerances with regional registrations. [Reserved]
(d) Indirect or inadvertant residues. [Reserved]
[FR Doc. 05-22254 Filed 11-8-05; 8:45 am]
BILLING CODE 6560-50-S