Document ID: EPA-HQ-OPP-2005-0254-0001
Agency: epa
Document Type: Rule
Title: Flucarbbazone-sodium: Time-limited Pesticide Tolerance Final Rule
Posted Date: 2005-11-09T05:00Z

[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 athttp://www.epa.gpo/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 (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.

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.

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 180.562 is revised to read as follows:

Sec.  180.562   Flucarbazone-sodium; tolerances for residues.

    (a) General. (1) Time-limited tolerances are established 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 the following food commodities:

------------------------------------------------------------------------
                                                          Expiration/
            Commodity              Parts per million    Revocation Date
------------------------------------------------------------------------
Wheat, forage...................  0.30..............  11/30/06
Wheat, grain....................  0.01..............  11/30/06
Wheat, hay......................  0.10..............  11/30/06
Wheat, straw....................  0.05..............  11/30/06
------------------------------------------------------------------------

    (2) Time-limited tolerances are established 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 metabolites converted to 2-
(trifluoromethoxy)benzene sulfonamide and calculated as flucarbazone-
sodium in or on the following food commodities:

------------------------------------------------------------------------
                                                          Expiration/
            Commodity              Parts per million    Revocation Date
------------------------------------------------------------------------
Cattle, liver...................  1.50..............  11/30/06
Cattle, meat....................  0.01..............  11/30/06
Cattle, meat byproducts except    0.01..............  11/30/06
 liver.
Goat, liver.....................  1.50..............  11/30/06
Goat, meat......................  0.01..............  11/30/06
Goat, meat byproducts except      0.01..............  11/30/06
 liver.
Hog, liver......................  1.50..............  11/30/06
Hog, meat.......................  0.01..............  11/30/06
Hog, meat byproducts except       0.01..............  11/30/06
 liver.
Horse, liver....................  1.50..............  11/30/06
Horse, meat.....................  0.01..............  11/30/06
Horse, meat byproducts except     0.01..............  11/30/06
 liver.
Milk............................  0.005.............  11/30/06
Sheep, liver....................  1.50..............  11/30/06
Sheep, meat.....................  0.01..............  11/30/06
Sheep, meat byproducts except     0.01..............  11/30/06
 liver.
------------------------------------------------------------------------

    (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]

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