Flucarbazone-sodium; Pesticide Tolerance, 76927-76932 [E6-21843]
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Federal Register / Vol. 71, No. 246 / Friday, December 22, 2006 / Rules and Regulations
(1) You commenced its construction
after December 24, 2002; and
(2) The construction is of a
completely new automobile and lightduty truck assembly plant, automobile
and light-duty truck paint shop,
automobile and light-duty truck topcoat
operation, other motor vehicle assembly
plant, other motor vehicle paint shop, or
other motor vehicle topcoat operation
where previously no automobile and
light-duty truck assembly plant,
automobile and light-duty truck
assembly paint shop, or automobile and
light-duty truck assembly topcoat
operation had existed; and
(i) No other motor vehicle assembly
plant, other motor vehicle paint shop, or
other motor vehicle topcoat operation
had existed previously; or
(ii) No previously existing other motor
vehicle assembly plant, other motor
vehicle paint shop, or other motor
vehicle topcoat operation is subject to
this subpart; or
(iii) If the facility was previously not
a major source for HAP, no previously
existing other motor vehicle assembly
plant, other motor vehicle paint shop, or
other motor vehicle topcoat operation is
made part of the affected source under
this subpart.
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5. Section 63.3110 is amended by
revising paragraph (b) to read as follows:
I
§ 63.3110
submit?
What notifications must I
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§ 63.3176
subpart?
What definitions apply to this
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Automobile and light-duty truck
assembly plant means a facility which
assembles automobiles or light-duty
trucks, including coating facilities and
processes.
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Other motor vehicle means a selfpropelled vehicle designed for
transporting persons or property on a
street or highway that has a gross
vehicle weight rating over 8,500
pounds. You may choose to make the
coating of other motor vehicles subject
to this subpart pursuant to § 63.3082(c).
Other motor vehicle assembly plant
means a facility which assembles other
motor vehicles, including coating
facilities and processes.
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Subpart MMMM—[Amended]
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(b) You must submit the Initial
Notification required by § 63.9(b) for a
new or reconstructed affected source no
later than 120 days after initial startup
or 120 days after June 25, 2004,
whichever is later. For an existing
affected source, you must submit the
Initial Notification no later than 1 year
after April 26, 2004. Existing sources
that have previously submitted
notifications of applicability of this rule
pursuant to § 112(j) of the CAA are not
required to submit an Initial
Notification under § 63.9(b) except to
identify and describe all additions to the
affected source made pursuant to
§ 63.3082(c). If you elect to include the
surface coating of new other motor
vehicle bodies, body parts for new other
motor vehicles, parts for new other
motor vehicles, or aftermarket repair or
replacement parts for other motor
vehicles in your affected source
pursuant to § 63.3082(c) and your
affected source has an initial startup
before February 20, 2007, then you must
submit an Initial Notification of this
election no later than 120 days after
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initial startup or February 20, 2007,
whichever is later.
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I 6. Section 63.3176 is amended by:
I a. Removing the definition of
‘‘Automobile and/or light-duty truck
assembly plant’’.
I b. Adding in alphabetical order
definitions for ‘‘Automobile and lightduty truck assembly plant,’’ ‘‘Other
motor vehicle,’’ and ‘‘Other motor
vehicle assembly plant’’ to read as
follows:
7. Section 63.3881 is amended by
revising the last sentence of paragraph
(d) to read as follows:
I
§ 63.3881
Am I subject to this subpart?
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(d) * * * Surface coating operations
on metal parts or products (e.g., parts for
motorcycles or lawnmowers) not
intended for use in automobiles, lightduty trucks, or other motor vehicles as
defined in § 63.3176 cannot be made
part of your affected source under
subpart IIII of this part.
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Subpart PPPP—[Amended]
8. Section 63.4481 is amended by
revising the last sentence of paragraph
(d) to read as follows:
I
§ 63.4481
Am I subject to this subpart?
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(d) * * * Surface coating operations
on plastic parts or products (e.g., parts
for motorcycles or lawnmowers) not
intended for use in automobiles, lightduty trucks, or other motor vehicles as
defined in § 63.3176 cannot be made
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part of your affected source under
subpart IIII of this part.
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[FR Doc. E6–21975 Filed 12–21–06; 8:45 am]
BILLING CODE 6560–50–P
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 180
[EPA–HQ–OPP–2006–0935; FRL–8105–6]
Flucarbazone–sodium; Pesticide
Tolerance
Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:
SUMMARY: This regulation establishes a
tolerance for combined residues of
flucarbazone-sodium, 4,5-dihydro-3methoxy-4-methyl-5-oxo-N[[2(trifluoromethoxy)phenyl] sulfonyl1H-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
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Federal Register / Vol. 71, No. 246 / Friday, December 22, 2006 / Rules and Regulations
available only in hard copy form.
Publicly available docket materials are
available in the electronic docket at
https://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
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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 https://
www.regulations.gov, you may access
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this Federal Register document
electronically through the EPA Internet
under the ‘‘Federal Register’’ listings at
https://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 https://
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: https://
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
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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, 4,5dihydro-3-methoxy-4-methyl-5-oxo-N[2(trifluoromethoxy)phenyl] sulfonyl1H-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 https://
www.epa.gov/fedrgstr/EPA-PEST/1997/
November/Day-26/p30948.htm.
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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, 4,5dihydro-3-methoxy-4-methyl-5-oxo-N[2(trifluoromethoxy)phenyl] sulfonyl1H-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 noobserved-adverse-effect-level (NOAEL)
and the lowest-observed-adverse-effectlevel (LOAEL) from the toxicity studies
can be found at https://docket.epa.gov/
edkpub/index.jsp.
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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
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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 nonthreshold 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 https://
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 flucarbazonesodium, 4,5-dihydro-3-methoxy-4methyl-5-oxo-N[2(trifluoromethoxy)phenyl] sulfonyl1H-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 (DEEMTM) 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
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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
(DEEMTM) 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 CallIns 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
https://docket.epa.gov/edkpub/index.jsp.
Based on the Generic Expected
Environmental Concentration (GENEEC)
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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 nonoccupational, 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 https://
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
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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 flucarbazonesodium 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.
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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; email 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 flucarbazonesodium 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 flucarbazonesodium, 4,5-dihydro-3-methoxy-4methyl-5-oxo-N[2(trifluoromethoxy)phenyl] sulfonyl1H-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.
E:\FR\FM\22DER1.SGM
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Federal Register / Vol. 71, No. 246 / Friday, December 22, 2006 / Rules and Regulations
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
VerDate Aug<31>2005
17:32 Dec 21, 2006
Jkt 211001
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
PO 00000
Frm 00035
Fmt 4700
Sfmt 4700
76931
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.
Therefore, 40 CFR chapter I is
amended as follows:
I
PART 180—[AMENDED]
1. The authority citation for part 180
continues to read as follows:
I
Authority: 21 U.S.C. 321(q), 346a and 371.
2. Section 180.562, paragraph (a) is
revised to read as follows:
I
§180.562 Flucarbazone-sodium;
tolerances for residues.
(a) General. Tolerances are
established for combined residues of the
herbicide flucarbazone-sodium, 4,5dihydro-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:
Commodity
Cattle, liver ................................
Cattle, meat ..............................
Cattle, meat byproducts except
liver ........................................
Goat, liver .................................
Goat, meat ................................
Goat, meat byproducts except
liver ........................................
Hog, liver ..................................
Hog, meat .................................
Hog, meat byproducts except
liver ........................................
Horse, liver ...............................
Horse, meat ..............................
Horse, meat by-products except liver ................................
Milk ...........................................
Sheep, liver ...............................
Sheep, meat .............................
Sheep, meat byproducts except
liver ........................................
Wheat, forage ...........................
Wheat, grain .............................
Wheat, hay ...............................
Wheat, straw .............................
E:\FR\FM\22DER1.SGM
22DER1
Parts per
million
1.50
0.01
0.01
1.50
0.01
0.01
1.50
0.01
0.01
1.50
0.01
0.01
0.005
1.50
0.01
0.01
0.30
0.01
0.10
0.05
76932
*
*
Federal Register / Vol. 71, No. 246 / Friday, December 22, 2006 / Rules and Regulations
*
*
*
[FR Doc. E6–21843 Filed 12–21–06; 8:45 am]
BILLING CODE 6560–50–S
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 372
[TRI–2005–0073; FRL–8260–4]
RIN 2025–AA14
Toxics Release Inventory Burden
Reduction Final Rule
Environmental Protection
Agency (EPA).
ACTION: Final rule.
jlentini on PROD1PC65 with RULES
AGENCY:
SUMMARY: EPA is revising the Toxics
Release Inventory (TRI) reporting
requirements to reduce burden while
continuing to provide valuable
information to the public, and promote
recycling and treatment as alternatives
to disposal and other releases. TRI
reporting is required by section 313 of
the Emergency Planning and
Community Right-to-Know Act (EPCRA)
and section 6607 of the Pollution
Prevention Act (PPA). This rule expands
non-Persistent Bioaccumulative and
Toxic (non-PBT) chemical eligibility for
Form A by raising the eligibility
threshold to 5,000 pounds of total
annual waste management (i.e., releases,
recycling, energy recovery, and
treatment for destruction) provided total
annual releases of the non-PBT
chemical comprise no more than 2,000
pounds of the 5,000-pound total waste
management limit. This rule also
allows, for the first time, limited use of
Form A for PBT chemicals when total
annual releases of a PBT chemical are
zero and the total annual amount of the
PBT chemical recycled, combusted for
energy, and treated for destruction does
not exceed 500 pounds. This rule,
however, retains the current exclusion
of dioxin and dioxin-like compounds
from Form A eligibility. By structuring
Form A eligibility for both PBT
chemicals and non-PBT chemicals in a
way that favors recycling and treatment
over disposal and other releases, today’s
rule encourages facilities to reduce their
releases and ensures that valuable
information will continue to be
provided to the public pursuant to the
purposes of section 313 of EPCRA and
section 6607 of PPA. Further, to guard
against situations where large nonproduction related amounts are not
reported on Form R and to provide
greater consistency between PBT
chemical and non-PBT chemical Form
A eligibility, this rule redefines the non-
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17:32 Dec 21, 2006
Jkt 211001
PBT Form A eligibility threshold to
include non-production related amounts
reported in Section 8.8 of Form R.
DATES: This rule is effective on January
22, 2007. The first reports with the
revised reporting requirements will be
due on or before July 1, 2007, for
reporting year (i.e., calendar year) 2006.
ADDRESSES: EPA has established a
docket for this action under Docket ID
No. TRI–2005–0073. All documents in
the docket are listed in the docket index
at https://www.regulations.gov. Although
listed in the index, some information is
not publicly available, i.e., confidential
business information (CBI) or other
information, the disclosure of which 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 at www.regulations.gov or
in hard copy at the OEI Docket, EPA/
DC, EPA West, Room B102, 1301
Constitution Ave., NW., Washington,
DC. The Public Reading Room is open
from 8:30 a.m. to 4:30 p.m., Monday
through Friday, excluding legal
holidays. The telephone number for the
Public Reading Room is (202) 566–1744,
and the telephone number for the OEI
Docket is (202) 566–1752. Note: The
EPA Docket Center suffered damage due
to flooding during the last week of June
2006. The Docket Center is continuing
to operate. However, during the
cleanup, there will be temporary
changes to Docket Center telephone
numbers, addresses, and hours of
operation for people who wish to visit
the Public Reading Room to view
documents. Consult EPA’s Federal
Register notice at 71 FR 38147 (July 5,
2006) or the EPA Web site at https://
www.epa.gov/epahome/dockets.htm for
current information on docket status,
locations and telephone numbers.
FOR FURTHER INFORMATION CONTACT: For
more specific information or technical
questions relating to this rule, contact
Marc Edmonds, Toxics Release
Inventory Program Division, Office of
Information Analysis and Access
(2844T), Environmental Protection
Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460; telephone
number: 202–566–0758; fax number:
202–566–0741; e-mail:
edmonds.marc@epa.gov; or Larry
Reisman, Toxics Release Inventory
Program Division, Office of Information
Analysis and Access (2844T),
Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington,
DC 20460; telephone number: 202–566–
0751; fax number: 202–566–0741; e-
PO 00000
Frm 00036
Fmt 4700
Sfmt 4700
mail: reisman.larry@epa.gov. The press
point of contact for this rule is Suzanne
Ackerman, Office of Public Affairs, 202–
564–7819. For general inquiries relating
to the Toxics Release Inventory or more
information on EPCRA section 313,
contact the TRI Information Center; toll
free: 1–800–424–9346, in Virginia and
Alaska: 703–412–9810, toll free TDD: 1–
800–553–7672, or TDD DC area local:
703–412–3323.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does This Action Apply to Me?
This action applies to facilities that
submit annual reports under section 313
of the Emergency Planning and
Community Right-to-Know Act (EPCRA)
and section 6607 of the Pollution
Prevention Act (PPA). It specifically
applies to those that submit the TRI
Form R or Form A Certification
Statement. (See https://www.epa.gov/tri/
report/index.htm#forms for detailed
information about EPA’s TRI reporting
forms.) To determine whether your
facility would be affected by this action,
you should carefully examine the
applicability criteria in part 372, subpart
B, of Title 40 of the Code of Federal
Regulations. If you have questions
regarding the applicability of this action
to a particular entity, consult the
individuals listed in the preceding FOR
FURTHER INFORMATION CONTACT section.
This action is also relevant to those
who utilize EPA’s TRI information,
including State agencies, local
governments, communities,
environmental groups and other nongovernmental organizations, as well as
members of the general public.
II. What is EPA’s Statutory Authority
for Taking This Action?
This rule is being issued under
sections 313(f)(2) and 328 of EPCRA, 42
U.S.C. 11023(f)(2) and 11048. In general,
section 313 of EPCRA and section 6607
of the PPA require owners and operators
of facilities in specified Standard
Industrial Classification (SIC) codes that
manufacture, process, or otherwise use
a listed toxic chemical in amounts
above specified threshold levels to
report certain facility-specific
information about such chemicals,
including the annual releases and other
waste management quantities. This
information is submitted on EPA Form
9350–1 (Form R) or EPA Form 9350–2
(Form A) and compiled in an annual
Toxics Release Inventory (TRI). Each
covered facility must file a separate
Form R for each listed chemical
manufactured, processed, or otherwise
used in excess of applicable reporting
E:\FR\FM\22DER1.SGM
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]]>Agencies
[Federal Register Volume 71, Number 246 (Friday, December 22, 2006)]
[Rules and Regulations]
[Pages 76927-76932]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-21843]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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 https://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 https://
www.regulations.gov, you may access this Federal Register document
electronically through the EPA Internet under the ``Federal Register''
listings at https://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 https://
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: https://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 https://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 https://
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 https://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 https://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 https://
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
------------------------------------------------------------------------
[[Page 76932]]
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[FR Doc. E6-21843 Filed 12-21-06; 8:45 am]
BILLING CODE 6560-50-S
