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67910 Federal Register / Vol. 70, No.

216 / Wednesday, November 9, 2005 / Rules and Regulations

established on the basis of a petition Thus, Executive Order 13175 does not § 180.930 Inert ingredients applied to
under FFDCA section 408(d), such as apply to this rule. animals; exemptions from the requirement
the exemptions in this final rule, do not of a tolerance.
XI. Congressional Review Act
require the issuance of a proposed rule,
Inert Ingredient Limits Uses
the requirements of the Regulatory The Congressional Review Act, 5
Flexibility Act (RFA) (5 U.S.C. 601 et U.S.C. 801 et seq., as added by the Small * * * * * * *
seq.) do not apply. In addition, the Business Regulatory Enforcement 2-Bromo-2-nitro- 0.04% or In-can pre-
Agency has determined that this action Fairness Act of 1996, generally provides 1,3- less by servative
will not have a substantial direct effect that before a rule may take effect, the propanediol weight of
on States, on the relationship between agency promulgating the rule must (CAS Reg. the total
the national government and the States, No. 52–51–7) pesticide
submit a rule report, which includes a formula-
or on the distribution of power and copy of the rule, to each House of the tion
responsibilities among the various Congress and to the Comptroller General * * * * * * *
levels of government, as specified in of the United States. EPA will submit a
Executive Order 13132, entitled report containing this rule and other * * * * *
Federalism (64 FR 43255, August 10, required information to the U.S. Senate,
1999). Executive Order 13132 requires [FR Doc. 05–22255 Filed 11–8–05; 8:45 am]
the U.S. House of Representatives, and
EPA to develop an accountable process the Comptroller General of the United BILLING CODE 6560–50–S

to ensure ‘‘meaningful and timely input States prior to publication of this final
by State and local officials in the rule in the Federal Register. This final
development of regulatory policies that ENVIRONMENTAL PROTECTION
rule is not a ‘‘major rule’’ as defined by
have federalism implications.’’ ‘‘Policies AGENCY
5 U.S.C. 804(2).
that have federalism implications’’ is 40 CFR Part 180
defined in the Executive Order to List of Subjects in 40 CFR Part 180
include regulations that have [OPP–2005–0254; FRL–7740–8]
Environmental protection,
‘‘substantial direct effects on the States, Administrative practice and procedure,
on the relationship between the national Flucarbazone-sodium; Time-Limited
Agricultural commodities, Pesticides Pesticide Tolerance
government and the States, or on the and pests, Reporting and recordkeeping
distribution of power and requirements. AGENCY: Environmental Protection
responsibilities among the various Agency (EPA).
levels of government.’’ This final rule Dated: October 28, 2005.
ACTION: Final rule.
directly regulates growers, food Lois Rossi,
processors, food handlers and food Director, Registration Division, Office of SUMMARY: This regulation establishes a
retailers, not States. This action does not Pesticide Programs. time-limited tolerance for combined
alter the relationships or distribution of residues of flucarbazone-sodium, 4,5-
power and responsibilities established ■Therefore, 40 CFR chapter I is dihydro-3-methoxy-4-methyl-5-oxo-N-
by Congress in the preemption amended as follows: [2(trifluoromethoxy)phenyl] sulfonyl-
provisions of FFDCA section 408(n)(4). 1H-1,2,4-triazole 1-carboxamide,
PART 180—[AMENDED] sodium salt and its N-desmethyl
For these same reasons, the Agency has
determined that this rule does not have metabolite in or on wheat, forage at 0.30
■ 1. The authority citation for part 180
any ‘‘tribal implications’’ as described parts per million (ppm); wheat, grain at
continues to read as follows:
in Executive Order 13175, entitled 0.01 ppm; wheat, hay at 0.10 ppm; and
Consultation and Coordination with Authority: 21 U.S.C. 321(q), 346a and 371. wheat, straw at 0.05 ppm; and combined
Indian Tribal Governments (65 FR ■ 2. In § 180.910 the table is amended residues of flucarbazone-sodium and its
67249, November 6, 2000). Executive by adding alphabetically the following metabolites converted to 2-
Order 13175, requires EPA to develop inert ingredient to read as follows: (trifluoromethoxy) benzene sulfonamide
an accountable process to ensure and calculated as flucarbazone-sodium
‘‘meaningful and timely input by tribal § 180.910 Inert ingredients used pre- and in or on milk at 0.005 ppm; meat and
officials in the development of post-harvest; exemptions from the meat byproducts (excluding liver) of
regulatory policies that have tribal requirement of a tolerance. cattle, goats, hogs, horses, and sheep at
implications.’’ ‘‘Policies that have tribal 0.01 ppm; and liver of cattle, goats,
implications’’ is defined in the Inert Ingredient Limits Uses hogs, horses, and sheep at 1.5 ppm.
Executive Order to include regulations Arysta LifeScience North America
* * * * * * *
that have ‘‘substantial direct effects on Corporation requested this tolerance
2-Bromo-2-nitro- 0.04% or In-can pre-
one or more Indian tribes, on the 1,3- less by servative
under the Federal Food, Drug, and
relationship between the Federal propanediol weight of Cosmetic Act (FFDCA), as amended by
Government and the Indian tribes, or on (CAS Reg. the total the Food Quality Protection Act of 1996
the distribution of power and No. 52–51–7) pesticide (FQPA). The tolerance will expire on
responsibilities between the Federal formula- November 30, 2006.
Government and Indian tribes.’’ This tion DATES: This regulation is effective
rule will not have substantial direct * * * * * * * November 9, 2005. Objections and
effects on tribal governments, on the requests for hearings must be received
relationship between the Federal * * * * * on or before January 9, 2006.
Government and Indian tribes, or on the ■ 3. In § 180.930 the table is amended ADDRESSES: To submit a written
distribution of power and by adding alphabetically the following objection or hearing request follow the
responsibilities between the Federal inert ingredient to read as follows: detailed instructions as provided in
Government and Indian tribes, as
specified in Executive Order 13175.

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Federal Register / Vol. 70, No. 216 / Wednesday, November 9, 2005 / Rules and Regulations 67911

Unit VI. of the SUPPLEMENTARY listed under FOR FURTHER INFORMATION flucarbazone-sodium in or on milk at
INFORMATION. EPA has established a CONTACT. 0.005 ppm; meat and meat byproducts
docket for this action under Docket (excluding liver) of cattle, goats, hogs,
B. How Can I Access Electronic Copies
identification (ID) number OPP–2005– horses, and sheep at 0.01 ppm; and liver
of this Document and Other Related
0254. All documents in the docket are of cattle, goats, hogs, horses, and sheep
Information?
listed in the EDOCKET index at http:// at 1.5 ppm. This notice included a
www.epa.gov/edocket. Although listed In addition to using EDOCKET (http:// summary of the petition prepared by
in the index, some information is not www.epa.gov/edocket/), you may access Arysta LifeScience North America
publicly available, i.e., CBI or other this Federal Register document Corporation, the registrant. Comments
information whose disclosure is electronically through the EPA Internet were received on the notice of filing.
restricted by statute. Certain other under the ‘‘Federal Register’’ listings at EPA response to those comments is
material, such as copyrighted material, http://www.epa.gov/fedrgstr/. A discussed in Unit IV.D.
is not placed on the Internet and will be frequently updated electronic version of The time limited-tolerance previously
publicly available only in hard copy 40 CFR part 180 is available at E-CFR issued September 29, 2000 (65 FR
form. Publicly available docket Beta Site Two at http:// 58364) (FRL–6745–9), will be extended
materials are available either www.gpoaccess.gov/ecfr/. To access the for 13 months and will expire on
electronically in EDOCKET or in hard OPPTS Harmonized Guidelines November 30, 2006. A time-limited
copy at the Public Information and referenced in this document, go directly tolerance will be issued due to
Records Integrity Branch (PIRIB), Rm. to the guidelines athttp://www.epa.gpo/ outstanding studies (independent
119, Crystal Mall #2, 1801 S. Bell St., opptsfrs/home/guidelin.htm/. laboratory validations of: Analytical
Arlington, VA. This docket facility is II. Background and Statutory Findings Method for the Determination O-
open from 8:30 a.m. to 4 p.m., Monday Desmethyl MKH 6562 (Metabolite of
through Friday, excluding legal In the Federal Register of September MKH 6562 in Soil by High Performance
holidays. The docket telephone number 29, 2000 (65 FR 58364) (FRL–6745–9), Liquid Chromatography Tandem Mass
EPA issued a time-limited tolerance for Spectrometry), Analytical Method for
is (703) 305–5805.
combined residues of the herbicide, the Determination of MKH 6562 and
FOR FURTHER INFORMATION CONTACT: Jim
flucarbazone-sodium, 4,5-dihydro-3- Metabolites NODT (N,O-
Tompkins, Registration Division methoxy-4-methyl-5-oxo-N-
(7505C), Office of Pesticide Programs, dimethyltriazolinone), Sulfonic Acid
[2(trifluoromethoxy)phenyl] sulfonyl- and Sulfonamide in Soil by High
Environmental Protection Agency, 1200 1H-1,2,4-triazole 1-carboxamide,
Pennsylvania Ave., NW., Washington, Performance Liquid Chromatography
sodium salt and its N-desmethyl Tandem Mass Spectrometry, and
DC 20460–0001; telephone number: metabolite in or on wheat, forage at 0.30
(703) 305–5697; e-mail Analytical Method for the
ppm; wheat, grain at 0.01 ppm; wheat, Determination of MKH 6562 and Three
address:Tompkins.Jim@epa.gov. hay at 0.10 ppm; and wheat, straw at Metabolites in Groundwater by High
SUPPLEMENTARY INFORMATION: 0.05 ppm; and combined residues of Performance Liquid Chromatography
flucarbazone-sodium and its metabolites Tandem Mass Spectrometry) will be
I. General Information
converted to 2-(trifluoromethoxy) submitted to the Agency by the
A. Does this Action Apply to Me? benzene sulfonamide and calculated as registrant in January 2006.
You may be potentially affected by flucarbazone-sodium in or on milk at Section 408(b)(2)(A)(i) of the FFDCA
this action if you are an agricultural 0.005 ppm; meat and meat byproducts allows EPA to establish a tolerance (the
producer, food manufacturer, or (excluding liver) of cattle, goats, hogs, legal limit for a pesticide chemical
pesticide manufacturer. Potentially horses, and sheep at 0.01 ppm; and liver residue in or on a food) only if EPA
affected entities may include, but are of cattle, goats, hogs, horses, and sheep determines that the tolerance is ‘‘safe.’’
not limited to: at 1.5 ppm. The tolerance will expire on Section 408(b)(2)(A)(ii) of the FFDCA
• Crop production (NAICS code 111) November 1, 2005. defines ‘‘safe’’ to mean that ‘‘there is a
• Animal production (NAICS code In the Federal Register of July 27, reasonable certainty that no harm will
112) 2005 (70 FR 43412) (FRL–7727–2), EPA result from aggregate exposure to the
• Food manufacturing (NAICS code issued a notice pursuant to section pesticide chemical residue, including
311) 408(d)(3) of the FFDCA, 21 U.S.C. all anticipated dietary exposures and all
• Pesticide manufacturing (NAICS 346a(d)(3), announcing the filing of a other exposures for which there is
code 32532) pesticide petition (PP 5F6949) by Arysta reliable information.’’ This includes
This listing is not intended to be LifeScience North America Corporation, exposure through drinking water and in
exhaustive, but rather provides a guide 100 First Street, Suite 1700, San residential settings, but does not include
for readers regarding entities likely to be Francisco, CA 94105. The petition occupational exposure. Section
affected by this action. Other types of requested that 40 CFR 180.562 be 408(b)(2)(C) of the FFDCA requires EPA
entities not listed in this unit could also amended by establishing a tolerance for to give special consideration to
be affected. The North American combined residues of the herbicide, exposure of infants and children to the
Industrial Classification System flucarbazone-sodium, 4,5-dihydro-3- pesticide chemical residue in
(NAICS) codes have been provided to methoxy-4-methyl-5-oxo-N- establishing a tolerance and to ‘‘ensure
assist you and others in determining [2(trifluoromethoxy)phenyl] sulfonyl- that there is a reasonable certainty that
whether this action might apply to 1H-1,2,4-triazole 1-carboxamide, no harm will result to infants and
certain entities. To determine whether sodium salt and its N-desmethyl children from aggregate exposure to the
you or your business may be affected by metabolite in or on wheat, forage at 0.30 pesticide chemical residue. . . .’’
this action, you should carefully ppm; wheat, grain at 0.01 ppm; wheat, EPA performs a number of analyses to
examine the applicability provisions in hay at 0.10 ppm; and wheat, straw at determine the risks from aggregate
http://docket.epa.gov/edkpub/index.jsp. 0.05 ppm; and combined residues of exposure to pesticide residues. For
If you have any questions regarding the flucarbazone-sodium and its metabolites further discussion of the regulatory
applicability of this action to a converted to 2-(trifluoromethoxy) requirements of section 408 of the
particular entity, consult the person benzene sulfonamide and calculated as FFDCA and a complete description of

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67912 Federal Register / Vol. 70, No. 216 / Wednesday, November 9, 2005 / Rules and Regulations

the risk assessment process, see http:// applied to reflect uncertainties inherent ii. Chronic exposure. In conducting
docket.epa.gov/edkpub/index.jsp. in the extrapolation from laboratory this chronic dietary exposure and risk
animal data to humans and in the assessment the DEEMTM analysis
III. Aggregate Risk Assessment and
variations in sensitivity among members evaluated the individual food
Determination of Safety
of the human population as well as consumption as reported by
Consistent with section 408(b)(2)(D) other unknowns. respondents in the USDA 1989–1992
of the FFDCA, EPA has reviewed the The linear default risk methodology Nationwide CSFII and accumulated
available scientific data and other (Q*) is the primary method currently exposure to the chemical for each
relevant information in support of this used by the Agency to quantify non- commodity.
action. EPA has sufficient data to assess threshold hazards such as cancer. The A summary of the chronic dietary
the hazards of and to make a Q* approach assumes that any amount exposure assessment is discussed in
determination on aggregate exposure, of exposure will lead to some degree of Unit III.C. of the final rule published in
consistent with section 408(b)(2) of the cancer risk, estimates risk in terms of the Federal Register of September 29,
FFDCA, for a tolerance for combined the probability of occurrence of 2000 (65 FR 58363).
residues of flucarbazone-sodium, 4,5- additional cancer cases. More iii. Cancer. A summary of the dietary
dihydro-3-methoxy-4-methyl-5-oxo-N- information can be found on the general exposure assessment is discussed in
[2(trifluoromethoxy)phenyl] sulfonyl- principles EPA uses in risk Unit III.C. of the final rule published in
1H-1,2,4-triazole 1-carboxamide, characterization at http:// the Federal Register of September 29,
sodium salt and its N-desmethyl docket.epa.gov/edkpub/index.jsp. 2000 (65 FR 58363).
metabolite in or on wheat, forage at 0.30 Section 408(b)(2)(E) of the FFDCA
A summary of the toxicological
ppm; wheat, grain at 0.01 ppm; wheat, authorizes EPA to use available data and
endpoints for flucarbazone-sodium used
hay at 0.10 ppm; and wheat, straw at information on the anticipated residue
for human risk assessment is discussed
0.05 ppm; and combined residues of levels of pesticide residues in food and
in Unit III.B. of the final rule published the actual levels of pesticide chemicals
flucarbazone-sodium and its metabolites
in the Federal Register of September 29, that have been measured in food. If EPA
converted to 2-(trifluoromethoxy)
2000 (65 FR 58363) (FRL–6745–9). relies on such information, EPA must
benzene sulfonamide and calculated as
flucarbazone-sodium in or on milk at C. Exposure Assessment require that data be provided 5 years
0.005 ppm; meat and meat byproducts after the tolerance is established,
1. Dietary exposure from food and modified, or left in effect, demonstrating
(excluding liver) of cattle, goats, hogs,
feed uses. Tolerances have been that the levels in food are not above the
horses, and sheep at 0.01 ppm; and liver
established 40 CFR 180.562 for the levels anticipated. Following the initial
of cattle, goats, hogs, horses, and sheep
combined residues of flucarbazone- data submission, EPA is authorized to
at 1.5 ppm. EPA’s assessment of
sodium, in or on wheat, forage at 0.30 require similar data on a time frame it
exposures and risks associated with
ppm; wheat, grain at 0.01 ppm; wheat, deems appropriate. As required by
establishing the tolerance follows.
hay at 0.10 ppm; and wheat, straw at section 408(b)(2)(E) of the FFDCA, EPA
A. Toxicological Profile 0.05 ppm; and combined residues of will issue a Data Call-In for information
EPA has evaluated the available flucarbazone-sodium and its metabolites relating to anticipated residues to be
toxicity data and considered its validity, converted to 2-(trifluoromethoxy) submitted no later than 5 years from the
completeness, and reliability as well as benzene sulfonamide and calculated as date of issuance of this tolerance.
the relationship of the results of the flucarbazone-sodium in or on milk at 2. Dietary exposure from drinking
studies to human risk. EPA has also 0.005 ppm; meat and meat byproducts water. The Agency lacks sufficient
considered available information (excluding liver) of cattle, goats, hogs, monitoring exposure data to complete a
concerning the variability of the horses, and sheep at 0.01 ppm; and liver comprehensive dietary exposure
sensitivities of major identifiable of cattle, goats, hogs, horses, and sheep analysis and risk assessment for
subgroups of consumers, including at 1.5 ppm. Risk assessments were flucarbazone-sodium in drinking water.
infants and children. Specific conducted by EPA to assess dietary Because the Agency does not have
information on the studies received and exposures from flucarbazone-sodium in comprehensive monitoring data,
the nature of the toxic effects caused by food as follows: drinking water concentration estimates
flucarbazone-sodium as well as the no i. Acute exposure. Quantitative acute are made by reliance on simulation or
observed adverse effect level (NOAEL) dietary exposure and risk assessments modeling taking into account data on
and the lowest observed adverse effect are performed for a food-use pesticide if the physical characteristics of
level (LOAEL) from the toxicity studies a toxicological study has indicated the flucarbazone-sodium. Further
can be found at http://docket.epa.gov/ possibility of an effect of concern information regarding EPA drinking
edkpub/index.jsp. occurring as a result of a one day or water models used in pesticide
single exposure. The Dietary Exposure exposure assessment can be found at
B. Toxicological Endpoints Evaluation Model (DEEMTM) analysis http://docket.epa.gov/edkpub/index.jsp.
For hazards that have a threshold evaluated the individual food A summary of the dietary exposure
below which there is no appreciable consumption as reported by from drinking water assessment is
risk, the dose at which no adverse respondents in the United States discussed in Unit III. C. of the final rule
effects are observed (the NOAEL) from Department of Agriculture (USDA) published in the Federal Register of
the toxicology study identified as 1989–1992 Nationwide Continuing September 29, 2000 (65 FR 58363).
appropriate for use in risk assessment is Surveys of Food Intake by Individuals Based on the generic expected
used to estimate the toxicological level (CSFII) and accumulated exposure to environmental concentration (GENEEC)
of concern (LOC). However, the lowest the chemical for each commodity. and screening concentration in ground
dose at which adverse effects of concern A summary of the acute dietary water (SCI-GROW) models, the
are identified (the LOAEL) is sometimes exposure assessment is discussed in estimated environmental concentrations
used for risk assessment if no NOAEL Unit III.C. of the final rule published in (EECs) of flucarbazone-sodium for acute
was achieved in the toxicology study the Federal Register of September 29, exposures are estimated to be 1.42 parts
selected. An uncertainty factor (UF) is 2000 (65 FR 58363). per billion (ppb) for surface water and

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0.2 ppb for ground water. The EECs for calculating a dose level that poses no analytical method for livestock
chronic exposures are estimated to be appreciable risk to humans. commodities is a common moiety
1.25 ppb for surface water and 0.2 ppb 2. Prenatal and postnatal sensitivity. method which measures residues of
for ground water. A summary of the prenatal and flucarbazone-sodium (MKH6562) in
3. From non-dietary exposure. The postnatal sensitivity assessment is animal tissues and milk by extracting
term ‘‘residential exposure’’ is used in discussed in Unit III.D. of the final rule and hydrolyzing MKH 6562 and MKH
this document to refer to non- published in the Federal Register of 6562-related residues to MKH 6562
occupational, non-dietary exposure September 29, 2000 (65 FR 58363). sulfonamide. Detection is achieved
(e.g., for lawn and garden pest control, 3. Conclusion. There is a complete using negative ion electrospray mass
indoor pest control, termiticides, and toxicity data base for flucarbazone- spectrometry using deuterated MKH
flea and tick control on pets). sodium and exposure data are complete 6562 sulfonamide as an internal
Flucarbazone-sodium is not registered or are estimated based on data that standard. Both methods have undergone
for use on any sites that would result in reasonably accounts for potential successful validations by independent
residential exposure. exposures. A summary of the safety laboratories and have been accepted by
4. Cumulative effects from substances factor is discussed in Unit III.D. of the the Agency. The analytical standards for
with a common mechanism of toxicity. final rule published in the Federal these methods are available from: Chief,
Section 408(b)(2)(D)(v) of the FFDCA Register of September 29, 2000 (65 FR Analytical Chemistry Branch,
requires that, when considering whether 58363). Environmental Science Center, 701
to establish, modify, or revoke a Mapes Rd., Ft. Meade, MD 20755–5350;
tolerance, the Agency consider E. Aggregate Risks and Determination of
telephone number: (410) 305–2905; e-
‘‘available information’’ concerning the Safety
mail address: residuemethods@epa.gov.
cumulative effects of a particular 1. Acute risk. A summary of the acute
pesticide’s residues and ‘‘other risk assessment is discussed in Unit B. International Residue Limits
substances that have a common III.E. of the final rule published in the A default Maximum Residue Limit
mechanism of toxicity.’’ Federal Register of September 29, 2000 (MRL) of 0.01 ppm has been established
Unlike other pesticides for which EPA (65 FR 58363). in Canada for residues of flucarbazone-
has followed a cumulative risk approach 2. Chronic risk. A summary of the sodium and its N-desmethyl metabolite
based on a common mechanism of chronic risk assessment is discussed in on wheat grain. This value is consistent
toxicity, EPA has not made a common Unit III.E. of the final rule published in with the tolerance being established in
mechanism of toxicity finding as to the Federal Register of September 29, the United States on wheat grain. There
flucarbazone-sodium and any other 2000 (65 FR 58363). are no Codex MRLs for this compound
substances and flucarbazone-sodium 3. Short-term risk. A summary of the on wheat. Therefore, no compatibility
does not appear to produce a toxic short-term risk assessment is discussed issues exist with Codex in regard to the
metabolite produced by other in Unit III.E. of the final rule published U.S. tolerances discussed in this review.
substances. For the purposes of this in the Federal Register of September 29,
tolerance action, therefore, EPA has not C. Conditions
2000 (65 FR 58363).
assumed that flucarbazone-sodium has a 4. Intermediate-term risk. A summary None.
common mechanism of toxicity with of the intermediate-term risk assessment
other substances. For information D. Comments
is discussed in Unit III.E. of the final
regarding EPA’s efforts to determine rule published in the Federal Register Public comments were received from
which chemicals have a common of September 29, 2000 (65 FR 58363). B. Sachau who objected to the proposed
mechanism of toxicity and to evaluate 5. Aggregate cancer risk for U.S. tolerances because of the supposed
the cumulative effects of such population. A summary of the aggregate harmful effects to the human genes. B.
chemicals, see the policy statements cancer risk for U.S. population Sachau’s comments contained no
released by EPA’s Office of Pesticide assessment is discussed in Unit III.E. of scientific data or evidence to rebut the
Programs concerning common the final rule published in the Federal Agency’s conclusion that there is a
mechanism determinations and Register of September 29, 2000 (65 FR reasonable certainty that no harm will
procedures for cumulating effects from 58363). result from aggregate exposure to
substances found to have a common 6. Determination of safety. Based on flucarbazone-sodium including all
mechanism on EPA’s website at http:// these risk assessments, EPA concludes anticipated dietary exposures and all
www.epa.gov/pesticides/cumulative/. that there is a reasonable certainty that other exposures for which there is
no harm will result to the general reliable information. EPA has responded
D. Safety Factor for Infants and
population, and to infants and children to B. Sachau’s generalized comments on
Children
from aggregate exposure to numerous previous occasions. 70 FR
1. In general. Section 408 of the 1349, 1354 (January 7, 2005); 69 FR
FFDCA provides that EPA shall apply flucarbazone-sodium residues.
63083, 63096 (October 29, 2004).
an additional tenfold margin of safety IV. Other Considerations
for infants and children in the case of V. Conclusion
threshold effects to account for prenatal A. Analytical Enforcement Methodology Therefore, the time-limited tolerance
and postnatal toxicity and the The petitioner has proposed residue (expires November 30, 2006) is
completeness of the data base on analytical methods for tolerance established for combined residues of
toxicity and exposure unless EPA enforcement in wheat and livestock flucarbazone-sodium, 4,5-dihydro-3-
determines that a different margin of commodities. The analytical methoxy-4-methyl-5-oxo-N-
safety will be safe for infants and enforcement method for wheat employs [2(trifluoromethoxy)phenyl] sulfonyl-
children. Margins of safety are accelerated solvent extraction, clean-up 1H-1,2,4-triazole 1-carboxamide,
incorporated into EPA risk assessments using solid phase extraction columns sodium salt and its N-desmethyl
either directly through use of a margin followed by detection and quantitation metabolite, in or on wheat, forage at
of exposure (MOE) analysis or through by liquid chromatography/tandem mass 0.30 ppm; wheat, grain at 0.01 ppm;
using uncertainty (safety) factors in spectroscopy (LC/MS/MS). The wheat, hay at 0.10 ppm; and wheat,

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67914 Federal Register / Vol. 70, No. 216 / Wednesday, November 9, 2005 / Rules and Regulations

straw at 0.05 ppm; and combined must be submitted for inclusion in the response to a petition submitted to the
residues of flucarbazone-sodium and its public record. Information not marked Agency. The Office of Management and
metabolites converted to 2- confidential may be disclosed publicly Budget (OMB) has exempted these types
(trifluoromethoxy) benzene sulfonamide by EPA without prior notice. of actions from review under Executive
and calculated as flucarbazone-sodium Mail your written request to: Office of Order 12866, entitled Regulatory
in or on milk at 0.005 ppm; meat and the Hearing Clerk (1900L), Planning and Review (58 FR 51735,
meat byproducts (excluding liver) of Environmental Protection Agency, 1200 October 4, 1993). Because this rule has
cattle, goats, hogs, horses, and sheep at Pennsylvania Ave., NW., Washington, been exempted from review under
0.01 ppm; and liver of cattle, goats, DC 20460–0001. You may also deliver Executive Order 12866 due to its lack of
hogs, horses, and sheep at 1.5ppm. your request to the Office of the Hearing significance, this rule is not subject to
Clerk in Suite 350, 1099 14th St., NW., Executive Order 13211, Actions
VI. Objections and Hearing Requests Washington, DC 20005. The Office of Concerning Regulations That
Under section 408(g) of the FFDCA, as the Hearing Clerk is open from 8 a.m. Significantly Affect Energy Supply,
amended by the FQPA, any person may to 4 p.m., Monday through Friday, Distribution, or Use (66 FR 28355, May
file an objection to any aspect of this excluding legal holidays. The telephone 22, 2001). This final rule does not
regulation and may also request a number for the Office of the Hearing contain any information collections
hearing on those objections. The EPA Clerk is (202) 564–6255. subject to OMB approval under the
procedural regulations which govern the 2. Copies for the Docket. In addition
Paperwork Reduction Act (PRA), 44
submission of objections and requests to filing an objection or hearing request
U.S.C. 3501 et seq., or impose any
for hearings appear in 40 CFR part 178. with the Hearing Clerk as described in
Although the procedures in those enforceable duty or contain any
Unit VI.A., you should also send a copy
regulations require some modification to unfunded mandate as described under
of your request to the PIRIB for its
reflect the amendments made to the inclusion in the official record that is Title II of the Unfunded Mandates
FFDCA by the FQPA, EPA will continue described in ADDRESSES. Mail your Reform Act of 1995 (UMRA) (Public
to use those procedures, with copies, identified by docket ID number Law 104–4). Nor does it require any
appropriate adjustments, until the OPP–2005–0254, to: Public Information special considerations under Executive
necessary modifications can be made. and Records Integrity Branch, Order 12898, entitled Federal Actions to
The new section 408(g) of the FFDCA Information Technology and Resources Address Environmental Justice in
provides essentially the same process Management Division (7502C), Office of Minority Populations and Low-Income
for persons to ‘‘object’’ to a regulation Pesticide Programs, Environmental Populations (59 FR 7629, February 16,
for an exemption from the requirement Protection Agency, 1200 Pennsylvania 1994); or OMB review or any Agency
of a tolerance issued by EPA under new Ave., NW., Washington, DC 20460– action under Executive Order 13045,
section 408(d), as was provided in the 0001. In person or by courier, bring a entitled Protection of Children from
old sections 408 and 409 of the FFDCA. copy to the location of the PIRIB Environmental Health Risks and Safety
However, the period for filing objections described in ADDRESSES. You may also Risks (62 FR 19885, April 23, 1997).
is now 60 days, rather than 30 days. send an electronic copy of your request This action does not involve any
via e-mail to: opp-docket@epa.gov. technical standards that would require
A. What Do I Need to Do to File an Agency consideration of voluntary
Objection or Request a Hearing? Please use an ASCII file format and
avoid the use of special characters and consensus standards pursuant to section
You must file your objection or any form of encryption. Copies of 12(d) of the National Technology
request a hearing on this regulation in electronic objections and hearing Transfer and Advancement Act of 1995
accordance with the instructions requests will also be accepted on disks (NTTAA), Public Law 104–113, section
provided in this unit and in 40 CFR part in WordPerfect 6.1/8.0 or ASCII file 12(d) (15 U.S.C. 272 note). Since
178. To ensure proper receipt by EPA, format. Do not include any CBI in your tolerances and exemptions that are
you must identify docket ID number electronic copy. You may also submit an established on the basis of a petition
OPP–2005–0254 in the subject line on electronic copy of your request at many under section 408(d) of the FFDCA,
the first page of your submission. All Federal Depository Libraries. such as the tolerance in this final rule,
requests must be in writing, and must be do not require the issuance of a
mailed or delivered to the Hearing Clerk B. When Will the Agency Grant a proposed rule, the requirements of the
on or before January 9, 2006. Request for a Hearing? Regulatory Flexibility Act (RFA) (5
1. Filing the request. Your objection A request for a hearing will be granted U.S.C. 601 et seq.) do not apply. The
must specify the specific provisions in if the Administrator determines that the Agency hereby certifies that this rule
the regulation that you object to, and the material submitted shows the following: will not have significant negative
grounds for the objections (40 CFR There is a genuine and substantial issue economic impact on a substantial
178.25). If a hearing is requested, the of fact; there is a reasonable possibility number of small entities. In addition,
objections must include a statement of that available evidence identified by the the Agency has determined that this
the factual issue(s) on which a hearing requestor would, if established resolve action will not have a substantial direct
is requested, the requestor’s contentions one or more of such issues in favor of effect on States, on the relationship
on such issues, and a summary of any the requestor, taking into account between the national government and
evidence relied upon by the objector (40 uncontested claims or facts to the the States, or on the distribution of
CFR 178.27). Information submitted in contrary; and resolution of the factual power and responsibilities among the
connection with an objection or hearing issue(s) in the manner sought by the various levels of government, as
request may be claimed confidential by requestor would be adequate to justify specified in Executive Order 13132,
marking any part or all of that the action requested (40 CFR 178.32). entitled Federalism (64 FR 43255,
information as CBI. Information so August 10, 1999). Executive Order
marked will not be disclosed except in VII. Statutory and Executive Order 13132 requires EPA to develop an
accordance with procedures set forth in Reviews accountable process to ensure
40 CFR part 2. A copy of the This final rule establishes a tolerance ‘‘meaningful and timely input by State
information that does not contain CBI under section 408(d) of the FFDCA in and local officials in the development of

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Federal Register / Vol. 70, No. 216 / Wednesday, November 9, 2005 / Rules and Regulations 67915

regulatory policies that have federalism List of Subjects in 40 CFR Part 180 Expiration/
Parts per
implications.’’ ‘‘Policies that have Environmental protection, Commodity million Revocation
federalism implications’’ is defined in Date
Administrative practice and procedure,
the Executive Order to include Agricultural commodities, Pesticides Hog, meat ........... 0.01 ........... 11/30/06
regulations that have ‘‘substantial direct and pests, Reporting and recordkeeping Hog, meat by- 0.01 ........... 11/30/06
effects on the States, on the relationship requirements. products except
between the national government and liver.
the States, or on the distribution of Dated: October 28, 2005.
Horse, liver .......... 1.50 ........... 11/30/06
power and responsibilities among the Lois Rossi, Horse, meat ........ 0.01 ........... 11/30/06
various levels of government.’’ This Director, Registration Division, Office of Horse, meat by- 0.01 ........... 11/30/06
final rule directly regulates growers, Pesticide Programs. products except
food processors, food handlers and food ■Therefore, 40 CFR chapter I is liver.
retailers, not States. This action does not amended as follows: Milk ...................... 0.005 ......... 11/30/06
alter the relationships or distribution of Sheep, liver ......... 1.50 ........... 11/30/06
PART 180—[AMENDED] Sheep, meat ........ 0.01 ........... 11/30/06
power and responsibilities established
Sheep, meat by- 0.01 ........... 11/30/06
by Congress in the preemption ■ 1. The authority citation for part 180 products except
provisions of section 408(n)(4) of the continues to read as follows: liver.
FFDCA. For these same reasons, the
Agency has determined that this rule Authority: 21 U.S.C. 321(q), 346a and 371.
(b) Section 18 emergency exemptions.
does not have any ‘‘tribal implications’’ ■ 2. Section 180.562 is revised to read [Reserved]
as described in Executive Order 13175, as follows: (c) Tolerances with regional
entitled Consultation and Coordination § 180.562 Flucarbazone-sodium; registrations. [Reserved]
with Indian Tribal Governments (65 FR tolerances for residues. (d) Indirect or inadvertant residues.
67249, November 6, 2000). Executive [Reserved]
(a) General. (1) Time-limited
Order 13175, requires EPA to develop
tolerances are established for combined [FR Doc. 05–22254 Filed 11–8–05; 8:45 am]
an accountable process to ensure
residues of the herbicide flucarbazone- BILLING CODE 6560–50–S
‘‘meaningful and timely input by tribal
sodium, 4,5-dihydro-3-methoxy-4-
officials in the development of
methyl-5-oxo-N-
regulatory policies that have tribal
[[2(trifluoromethoxy)phenyl] sulfonyl]- FEDERAL COMMUNICATIONS
implications.’’ ‘‘Policies that have tribal
1H-1,2,4-triazole 1-carboxamide, COMMISSION
implications’’ is defined in the
sodium salt) and its N-desmethyl
Executive Order to include regulations
metabolite in or on the following food 47 CFR Parts 20 and 68
that have ‘‘substantial direct effects on
one or more Indian tribes, on the commodities:
[WT Docket 01–309, FCC 05–166]
relationship between the Federal Expiration/
Government and the Indian tribes, or on Commodity Parts per Revocation Hearing Aid Compatibility
the distribution of power and million Requirements for Wireless Carriers
Date
responsibilities between the Federal Offering Dual-Band GSM Handsets;
Government and Indian tribes.’’ This Wheat, forage ..... 0.30 ........... 11/30/06 Request for Waiver of Hearing Aid
rule will not have substantial direct Wheat, grain ........ 0.01 ........... 11/30/06 Compatibility Requirements for
effects on tribal governments, on the Wheat, hay .......... 0.10 ........... 11/30/06 Cingular Wireless LLC
Wheat, straw ....... 0.05 ........... 11/30/06
relationship between the Federal AGENCY: Federal Communications
Government and Indian tribes, or on the (2) Time-limited tolerances are Commission.
distribution of power and established for combined residues of the ACTION: Final rule; petitions for waiver.
responsibilities between the Federal herbicide flucarbazone-sodium, 4,5-
Government and Indian tribes, as dihydro-3-methoxy-4-methyl-5-oxo-N- SUMMARY: The Federal Communications
specified in Executive Order 13175. [[2(trifluoromethoxy)phenyl] sulfonyl]- Commission (FCC or Commission) ruled
Thus, Executive Order 13175 does not 1H-1,2,4-triazole 1-carboxamide, that, until August 1, 2006, it will base
apply to this rule. the hearing aid compatibility
sodium salt) and its metabolites
VIII. Congressional Review Act converted to 2- compliance rating of dual-band GSM
(trifluoromethoxy)benzene sulfonamide handsets on their operation in the 1900
The Congressional Review Act, 5
and calculated as flucarbazone-sodium MHz band only. Given its broad
U.S.C. 801et seq., as added by the Small
in or on the following food applicability, the Commission clarified
Business Regulatory Enforcement
commodities: that its action applies to all handset
Fairness Act of 1996, generally provides
manufacturers, carriers and service
that before a rule may take effect, the
Expiration/ providers that offer dual-band GSM
agency promulgating the rule must Commodity Parts per Revocation
submit a rule report, which includes a million wireless handsets that operate in both
Date the 850 MHz and 1900 MHz bands.
copy of the rule, to each House of the
Congress and to the Comptroller General Cattle, liver .......... 1.50 ........... 11/30/06 Consistent with this action, the
of the United States. EPA will submit a Cattle, meat ......... 0.01 ........... 11/30/06 Commission granted in part a request
report containing this rule and other Cattle, meat by- 0.01 ........... 11/30/06 from Cingular Wireless LLC (Cingular).
required information to the U.S. Senate, products except Finally, the Commission imposed
the U.S. House of Representatives, and liver. conditions on Cingular and all other
Goat, liver ............ 1.50 ........... 11/30/06 entities that elect to avail themselves of
the Comptroller General of the United Goat, meat .......... 0.01 ........... 11/30/06
States prior to publication of this final the temporary relief granted by the
Goat, meat by- 0.01 ........... 11/30/06 Memorandum Opinion and Order
rule in the Federal Register. This final products except
rule is not a ‘‘major rule’’ as defined by liver.
(MO&O).
5 U.S.C. 804(2). Hog, liver ............. 1.50 ........... 11/30/06 DATES: Effective September 8, 2005.

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