Document ID: EPA-HQ-OPP-2006-0935-0001
Agency: epa
Document Type: Rule
Title: Flucarbazone-sodium; Pesticide Tolerance
Posted Date: 2006-12-22T05:00Z

[Federal Register: December 22, 2006 (Volume 71, Number 246)]
[Rules and Regulations]               
[Page 76927-76932]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr22de06-14]                         

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2006-0935; FRL-8105-6]

 
Flucarbazone-sodium; Pesticide Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes 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 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, 15401 Weston Parkway, Suite 150, 
Cary, NC 27513 requested this tolerance under the Federal Food, Drug, 
and Cosmetic Act (FFDCA), as amended by the Food Quality Protection Act 
of 1996 (FQPA).

DATES: This regulation is effective December 22, 2006. Objections and 
requests for hearings must be received on or before February 20, 2007, 
and must be filed in accordance with the instructions provided in 40 
CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES:  EPA has established a docket for this action under docket 
identification (ID) number EPA-HQ-OPP-2006-0935. All documents in the 
docket are listed in the index for the docket. Although listed in the 
index, some information is not publicly available, e.g., Confidential 
Business Information (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

[[Page 76928]]

available only in hard copy form. Publicly available docket materials 
are available in the electronic docket at http://www.regulations.gov, 

or, if only available in hard copy, at the OPP Regulatory Public Docket 
in Rm. S-4400, One Potomac Yard (South Building), 2777 S. Crystal 
Drive, Arlington, VA. The 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 
(7505P), 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 111), e.g., agricultural workers; 
greenhouse, nursery, and floriculture workers; farmers.
     Animal production (NAICS 112), e.g., cattle ranchers and 
farmers, dairy cattle farmers, livestock farmers.
     Food manufacturing (NAICS 311), e.g., agricultural 
workers; farmers; greenhouse, nursery, and floriculture workers; 
ranchers; pesticide applicators.
     Pesticide manufacturing (NAICS 32532), e.g., agricultural 
workers; commercial applicators; farmers; greenhouse, nursery, and 
floriculture workers; residential users.
    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. 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?

    In addition to accessing an electronic copy of this Federal 
Register document through the electronic docket at http://www.regulations.gov
, you may access this Federal Register document 

electronically through the EPA Internet under the ``Federal Register'' 
listings at http://www.epa.gov/fedrgstr. You may also access a 

frequently updated electronic version of 40 CFR part 180 through the 
Government Printing Office's pilot e-CFR site at http://www.gpoaccess.gov/ecfr
.

C. Can I File an Objection or Hearing Request?

    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. You must file your objection or 
request a hearing on this regulation in accordance with the 
instructions provided in 40 CFR part 178. To ensure proper receipt by 
EPA, you must identify docket ID number EPA-HQ-OPP-2006-0935. 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 February 20, 2007.
    In addition to filing an objection or hearing request with the 
Hearing Clerk as described in 40 CFR part 178, please submit a copy of 
the filing that does not contain any CBI for inclusion in the public 
docket that is described in ADDRESSES. Information not marked 
confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA 
without prior notice. Submit your copies, identified by docket ID 
number EPA-HQ-OPP-2006-0935, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov. 

Follow the on-line instructions for submitting comments.
     Mail: Office of Pesticide Programs (OPP) Regulatory Public 
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania 
Ave., NW., Washington, DC 20460-0001.
     Delivery: OPP Regulatory Public Docket (7502P), 
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South 
Building), 2777 S. Crystal Drive, Arlington, VA. Deliveries are only 
accepted during the Docket's normal hours of operation (8:30 a.m. to 4 
p.m., Monday through Friday, excluding legal holidays). Special 
arrangements should be made for deliveries of boxed information. The 
Docket telephone number is (703) 305-5805.

II. Background and Statutory Findings

    In the Federal Register of October 20, 2006 (70 FR 61969) (FRL-
8099-1), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21 
U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP 
6F7112) by Arysta LifeScience North America Corporation, 15401 Weston 
Parkway, Suite 150, Cary, NC 27513. The petition requested that 40 CFR 
180.562 be amended by establishing 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 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. That notice 
included a summary of the petition prepared by Arysta LifeScience North 
America Corporation, the registrant. There were no comments received in 
response to the notice of filing.
    Section 408(b)(2)(A)(i) of 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 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 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 the risk assessment process, see http://www.epa.gov/fedrgstr/EPA-PEST/1997/November/Day-26/p30948.htm
.

[[Page 76929]]

III. Aggregate Risk Assessment and Determination of Safety

    Consistent with section 408(b)(2)(D) of 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 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 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. 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.govedkpub/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 
58364) (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, 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. 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 1-day or single exposure.
    The Dietary Exposure Evaluation Model (DEEM\TM\) analysis evaluated 
the individual food consumption as reported by respondents in the USDA 
1989-1992 Nationwide Continuing Surveys of Food Intake by Individuals 
(CSFII) and accumulated exposure to the chemical for each commodity. 
The following assumptions were made for the acute exposure assessments: 
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 58364).
    ii. Chronic exposure. In conducting this chronic dietary 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. 
The following assumptions were made for the chronic exposure 
assessments: 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 58364).
    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 58364).
    iv. Anticipated residue and percent crop treated (PCT) information. 
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 pursuant 
to section 408(f)(1) 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. For the present action, EPA will 
issue such Data Call-Ins for information relating to anticipated 
residues as are required by FFDCA section 408(b)(2)(E) and authorized 
under FFDCA section 408(f)(1). Such Data Call-Ins will be required 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 flucarabazone-sodium. Further information 
regarding EPA drinking water models used in pesticide exposure 
assessment can be found at http://docket.epa.gov/edkpub/index.jsp.

    Based on the Generic Expected Environmental Concentration (GENEEC)

[[Page 76930]]

and Screening Concentrations in Groundwater (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 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 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 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 based on reliable data 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 analysis or through using uncertainty (safety) 
factors in calculating a dose level that poses no appreciable risk to 
humans. In applying this provision, EPA either retains the default 
value of 10X when reliable data do not support the choice of a 
different factor, or, if reliable data are available, EPA uses a 
different additional safety factor value based on the use of 
traditional uncertainty factors and/or special FQPA safety factors, as 
appropriate.
    2. Prenatal and postnatal sensitivity. A summary of the prenatal 
and postnatal sensitivity assessment is discussed in the Federal 
Register of September 29, 2000 (65 FR 58364).
    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 
58364).

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 58364).
    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 58364).
    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 58364).
    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 58364).
    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 58364).
    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 (MKH 6562) 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.

V. Conclusion

    Therefore, the tolerance 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 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.

[[Page 76931]]

VI. Statutory and Executive Order Reviews

    This final rule establishes a tolerance under section 408(d) of 
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 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 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 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.

VII. 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: December 14, 2006.
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, paragraph (a) is revised to read as follows:

Sec. 180.562  Flucarbazone-sodium; tolerances for residues.

    (a) General. 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; and its 
metabolites converted to 2-(trifluoromethoxy)benzene sulfonamide and 
calculated as flucarbazone-sodium in or on the following food 
commodities:

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
Cattle, liver..............................................         1.50
Cattle, meat...............................................         0.01
Cattle, meat byproducts except liver.......................         0.01
Goat, liver................................................         1.50
Goat, meat.................................................         0.01
Goat, meat byproducts except liver.........................         0.01
Hog, liver.................................................         1.50
Hog, meat..................................................         0.01
Hog, meat byproducts except liver..........................         0.01
Horse, liver...............................................         1.50
Horse, meat................................................         0.01
Horse, meat by-products except liver.......................         0.01
Milk.......................................................        0.005
Sheep, liver...............................................         1.50
Sheep, meat................................................         0.01
Sheep, meat byproducts except liver........................         0.01
Wheat, forage..............................................         0.30
Wheat, grain...............................................         0.01
Wheat, hay.................................................         0.10
Wheat, straw...............................................         0.05
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[[Page 76932]]

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[FR Doc. E6-21843 Filed 12-21-06; 8:45 am]

BILLING CODE 6560-50-S