Flumioxazin; Pesticide Tolerance, 25951-25956 [06-4159]
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Federal Register / Vol. 71, No. 85 / Wednesday, May 3, 2006 / Rules and Regulations
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. 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
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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.
25951
and pests, Reporting and recordkeeping
requirements.
Dated: April 27, 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 180.433 is revised to read
as follows:
I
§ 180.433 Fomesafen; tolerances for
residues.
(a) General. Tolerances are
established for the residues of fomesafen
5-[2-chloro-4-(trifluoromethyl)phenoxy]N-(methylsulfonyl)-2-nitrobenzamide
from the application of its sodium salt
in or on the following commodities:
Commodity
Parts per
million
Bean, dry ..................................
Bean, snap, succulent ..............
Cotton, gin byproducts .............
Cotton, undelinted seed ...........
Soybean ....................................
0.025
0.025
0.025
0.025
0.05
(b) Section 18 emergency exemptions.
[Reserved]
(c) Tolerances with regional
registrations. [Reserved]
(d) Indirect or inadvertent residues.
[Reserved]
[FR Doc. 06–4160 Filed 5–2–06; 8:45 am]
BILLING CODE 6560–50–S
VIII. 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
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ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 180
[EPA–HQ–OPP–2004–0398; FRL–8057–5]
Flumioxazin; Pesticide Tolerance
Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:
SUMMARY: This regulation establishes
tolerances for residues of flumioxazin,
2-[7-fluoro-3,4-dihydro-3-oxo-4-(2propynyl)-2H-1,4-benzoxazin-6-yl]4,5,6,7-tetrahydro-1H-isoindole-1,3(2H)dione in or on pome fruit crop group 11,
stone fruit crop group 12 and
strawberry. Valent U.S.A. Corporation
requested this tolerance under the
Federal Food, Drug, and Cosmetic Act
(FFDCA), as amended by the Food
Quality Protection Act of 1996 (FQPA).
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This regulation is effective May
3, 2006. Actions and requests for
hearings must be received on or before
July 3, 2006.
ADDRESSES: To submit a written
objection or hearing request follow the
detailed instructions as provided in
Unit VI. of the SUPPLEMENTARY
INFORMATION. EPA has established a
docket for this action under Docket
identification (ID) number EPA–HQ–
OPP–2004–0398. All documents in the
docket are listed on the regulations.gov
Web site. (EDOCKET, EPA’s electronic
public docket and comment system was
replaced on November 25, 2005, by an
enhanced federal-wide electronic docket
management and comment system
located at https://www.regulations.gov.
Follow the on-line instructions.)
Although listed in the index, some
information is not publicly available,
i.e., 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
available only in hard copy form.
Publicly available docket materials are
available either electronically in
EDOCKET or in hard copy at the Public
Information and Records Integrity
Branch (PIRIB), Rm. 119, Crystal Mall
#2, 1801 S. Bell St., Arlington, VA. This
docket facility is open from 8:30 a.m. to
4 p.m., Monday through Friday,
excluding legal holidays. The docket
telephone number is (703) 305–5805.
• Important Note: OPP will be
moving to a new location the first week
of May 2006. As a result, from Friday,
April 28 to Friday, May 5, 2006, the
OPP Regulatory Public Docket will NOT
be accepting any deliveries at the
Crystal Mall #2 address and this facility
will be closed to the public. Beginning
on May 8, 2006, the OPP Regulatory
Public Docket will reopen at 8:30 a.m.
and deliveries will be accepted in Rm.
S–4400, One Potomac Yard (South
Building), 2777 S. Crystal Drive,
Arlington, VA 22202. The mail code for
the mailing address will change to
(7502P), but will otherwise remain the
same. The OPP Regulatory Public
Docket telephone number and hours of
operation will remain the same after the
move.
FOR FURTHER INFORMATION CONTACT:
Joanne I. Miller, Registration Division
(7505C), Office of Pesticide Programs,
Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington,
DC 20460–0001; telephone number:
(703) 305–6224; e-mail address:
miller.joanne@epamail.epa.gov.
SUPPLEMENTARY INFORMATION:
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DATES:
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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 and Other Related
Information?
In addition to using EDOCKET (https://
www.epa.gov/edocket), you may access
this Federal Register document
electronically through the EPA Internet
under the ‘‘Federal Register’’ listings at
https://www.epa.gov/fedrgstr. A
frequently updated electronic version of
40 CFR part 180 is available at E-CFR
Beta Site Two at https://
www.gpoaccess.gov/ecfr. To access the
OPPTS Harmonized Guidelines
referenced in this document, go directly
to the guidelines at https://www.epa.gpo/
opptsfrs/home/guidelin.htm.
II. Background and Statutory Findings
In the Federal Register of December 8,
2004 (69 FR 71045) (FRL–7689–1), 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 4F6829) by Valent
U.S.A. Corporation, 1333 North
California Boulevard, Suite 600, Walnut
Creek, California 94596–8025. The
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petition requested that 40 CFR 180.568
be amended by establishing tolerances
for residues of the herbicide
flumioxazin, 2-[7-fluoro-3,4-dihydro-3oxo-4-(2-propynyl)-2H-1,4-benzoxazin6-yl]-4,5,6,7-tetrahydro-1H-isoindole1,3(2H)-dione, in or on fruit, pome
group 11 at 0.02 parts per million (ppm)
and fruit, stone, group 12 at 0.02 ppm.
In the Federal Register of April 8,
2005 (70 FR 18004) (FRL–7689–1), 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 4E6845) by
Interregional Research Project Number 4
(IR–4), Rutgers, State University of New
Jersey, 681 U.S. Highway #1 S., North
New Brunswick, NJ 08902. The petition
requested that 40 CFR 180.568 be
amended by establishing tolerances for
residues of the herbicide flumioxazin, 2[7-fluoro-3,4-dihydro-3-oxo-4-(2propynyl)-2H-1,4-benzoxazin-6-yl]4,5,6,7-tetrahydro-1H-isoindole-1,3(2H)dione, in or on strawberry at 0.10 ppm.
These notices included a summary of
the petitions prepared by Valent U.S.A.
Corporation, the registrant and
Interregional Research Project Number 4
(IR-4). Based on residue chemistry
strawberry field trials the strawberry
tolerance is being lowered to 0.07 ppm.
One comment was received on the
notices of filing. EPA’s response to this
comment is discussed in Unit IV.C.
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://
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www.epa.gov/fedrgstr/EPA-PEST/1997/
November/Day-26/p30948.htm.
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 tolerances for residues of
flumioxazin on fruit, pome, group 11 at
0.02 ppm, fruit, stone, group 12 at 0.02
ppm, and strawberry at 0.07 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
flumioxazin as well as the no-observedadverse-effect-level (NOAEL) and the
lowest-observed-adverse-effect-level
(LOAEL) from the toxicity studies are
discussed in the Federal Register of
August 25, 2004 (69 FR 52192) (FRL–
7369–9).
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B. Toxicological Endpoints
A summary of the toxicological
endpoints for flumioxazin used for
human risk assessment is discussed in
Unit III.B. of the final rule published in
the Federal Register of August 25, 2004
(69 FR 52192) (FRL–7369–9).
C. Exposure Assessment
1. Dietary exposure from food and
feed uses. Tolerances have been
established (40 CFR 180.568) for the
residues of flumioxazin, in or on a
variety of raw agricultural commodities.
Risk assessments were conducted by
EPA to assess dietary exposures from
flumioxazin 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.
In conducting the acute dietary risk
assessment EPA used the Dietary
Exposure Evaluation Model software
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with the Food Commodity Intake
Database (DEEM-FCIDTM), which
incorporates food consumption data as
reported by respondents in the U.S.
Department of Agriculture (USDA)
1994–1996 and 1998 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: For the acute analyses,
tolerance-level residues were assumed
for all food commodities with current or
proposed flumioxazin tolerances, and it
was assumed that all of the crops
included in the analysis were treated.
Percent Crop Treated (PCT) and/or
anticipated residues were not used in
the acute risk assessment.
ii. Chronic exposure. In conducting
the chronic dietary risk assessment EPA
used the DEEM-FCIDTM, which
incorporates food consumption data as
reported by respondents in the USDA
1994–1996 and 1998 Nationwide CSFII,
and accumulated exposure to the
chemical for each commodity. The
following assumptions were made for
the chronic exposure assessments: For
the chronic analyses, tolerance-level
residues were assumed for all food
commodities with current or proposed
flumioxazin tolerances, and it was
assumed that all of the crops included
in the analysis were treated. PCT and/
or anticipated residues were not used in
the chronic risk assessment.
2. Dietary exposure from drinking
water. The Agency lacks sufficient
monitoring exposure data to complete a
comprehensive dietary exposure
analysis and risk assessment for
flumioxazin and its degradates (482-HA
and APF) 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 flumioxazin and its
degradates (482-HA and APF).
The Agency uses the FQPA Index
Reservoir Screening Tool (FIRST) or the
Pesticide Root Zone Model/Exposure
Analysis Modeling System (PRZM/
EXAMS), to produce estimates of
pesticide concentrations in an index
reservoir. The screening concentration
in ground water (SCI-GROW) model is
used to predict pesticide concentrations
in shallow ground water. For a
screening-level assessment for surface
water EPA will use FIRST (a Tier 1
model) before using PRZM/EXAMS (a
Tier 2 model). The FIRST model is a
subset of the PRZM/EXAMS model that
uses a specific high-end runoff scenario
for pesticides. Both FIRST and PRZM/
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25953
EXAMS incorporate an index reservoir
environment, and both models include
a percent crop area factor as an
adjustment to account for the maximum
percent crop coverage within a
watershed or drainage basin.
None of these models include
consideration of the impact processing
(mixing, dilution, or treatment) of raw
water for distribution as drinking water
would likely have on the removal of
pesticides from the source water. The
primary use of these models by the
Agency at this stage is to provide a
screen for sorting out pesticides for
which it is unlikely that drinking water
concentrations would exceed human
health levels of concern.
Since the models used are considered
to be screening tools in the risk
assessment process, the Agency uses the
estimated environmental concentrations
(EECs), which are the model estimates
of a pesticide’s concentration in water.
EECs derived from these models are
used to quantify drinking water
exposure and risk as a percent reference
dose (%RfD) or percent population
adjusted dose (%PAD).
Based on the FIRST and SCI-GROW
models, the EECs of flumioxazin and its
degradates (482-HA and APF) for acute
exposures are estimated to be a total of
34 parts per billion (ppb) for surface
water and 48 ppb for ground water. The
EECs for chronic exposures are
estimated to be a total of 18 ppb for
surface water and 48 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).
Flumioxazin is not registered for use
on any sites that would result in
residential exposure.
4. Cumulative effects from substances
with a common mechanism of toxicity.
Section 408(b)(2)(D)(v) of the FFDCA
requires that, when considering whether
to establish, modify, or revoke a
tolerance, the Agency consider
‘‘available information’’ concerning the
cumulative effects of a particular
pesticide’s residues and ‘‘other
substances that have a common
mechanism of toxicity.’’
Unlike other pesticides for which EPA
has followed a cumulative risk approach
based on a common mechanism of
toxicity, EPA has not made a common
mechanism of toxicity finding as to
flumioxazin and any other substances
and flumioxazin does not appear to
produce a toxic metabolite produced by
other substances. For the purposes of
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this tolerance action, therefore, EPA has
not assumed that flumioxazin 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 Web site 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 database 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 (MOE) 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.
Although increased prenatal and
postnatal quantitative susceptibility was
seen in rats, it was concluded that there
is low concern and no residual
uncertainties for prenatal and/or
postnatal toxicity because:
i. Developmental toxicity NOAELs/
LOAELs are well characterized after oral
and dermal exposure.
ii. Offspring toxicity NOAEL/LOAEL
are well characterized.
iii. There is a well-defined doseresponse curve for the cardiovascular
effects seen following oral exposure
(i.e., critical period).
iv. The endpoints of concern are used
for overall risk assessments for
appropriate route and population
subgroups.
3. Conclusion. There is a complete
toxicity database for flumioxazin and
exposure data are complete or are
estimated based on data that reasonably
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accounts for potential exposures. The
developmental toxicity and offspring
toxicity NOAELs/LOAELs are well
characterized. There is a well-defined
dose-response curve for the
cardiovascular effects and the endpoints
of concern are used for overall risk
assessments and are appropriate for the
route of exposure and population
subgroups. The dietary food exposure
assessment utilizes tolerance level
residues and 100% crop treated (CT)
information for all commodities. By
using these screening-level
assumptions, chronic exposures/risks
will not be underestimated. The dietary
drinking water assessment utilizes
values generated by models and
associated modeling parameters which
are designed to provide conservative,
health protective, high-end estimates of
water concentrations. Accordingly, the
additional 10X factor for the protection
of infants and children is removed.
E. Aggregate Risks and Determination of
Safety
1. Acute risk. Using the exposure
assumptions discussed in this Unit for
acute exposure, the acute dietary
exposure from food and drinking water
to flumioxazin will occupy 8% of the
acute population adjusted dose (aPAD)
for females 13 to 49 years old (the only
subgroup for which an acute endpoint
was selected).
2. Chronic risk. Using the exposure
assumptions described in this Unit for
chronic exposure, EPA has concluded
that exposure to flumioxazin from food
and drinking water will utilize 6% of
the chronic population adjusted dose
(cPAD) for the U.S. population, 18% of
the cPAD for all infants less than 1–year
old, and 11% of the cPAD for children
1–2 years old. There are no residential
uses for flumioxazin that result in
chronic residential exposure to
flumioxazin.
3. Short-term risk. Short-term
aggregate exposure takes into account
residential exposure plus chronic
exposure to food and water (considered
to be a background exposure level).
Flumioxazin is not registered for use
on any sites that would result in
residential exposure. Therefore, the
aggregate risk is the sum of the risk from
food and water, which do not exceed
the Agency’s level of concern.
4. 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 flumioxazin
residues.
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IV. Other Considerations
A. Analytical Enforcement Methodology
Adequate enforcement methodology
(gas chromatography-nitrogen
phosphorus detection) is available to
enforce the tolerance expression. The
method may be requested 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
There are no Codex, Canadian or
Mexican maximum residue limits
established for flumioxazin on fruit,
pome, fruit, stone or strawberry.
C. Response to Comments
Public comments were received from
B. Sachau who objected to the proposed
tolerances because of the amounts of
pesticides already consumed and
carried by the American population.
She further indicated that testing
conducted on animals have absolutely
no validity and are cruel to the test
animals. B. Sachau’s comments
contained no scientific data or evidence
to rebut the Agency’s conclusion that
there is a reasonable certainty that no
harm will result from aggregate
exposure to flumioxazin, including all
anticipated dietary exposures and all
other exposures for which there is
reliable information. EPA has responded
to B. Sachau’s generalized comments on
numerous previous occasions. (70 FR
1349, January 7, 2005); 69 FR 63083,
October 29, 2004.
V. Conclusion
Therefore, the tolerance is established
for residues of flumioxazin, 2-[7-fluoro3,4-dihydro-3-oxo-4-(2-propynyl)-2H1,4-benzoxazin-6-yl]-4,5,6,7-tetrahydro1H-isoindole-1,3(2H)-dione, in or on
fruit, pome, group 11 at 0.02 ppm, fruit,
stone, group 12 at 0.02 ppm, and
strawberry at 0.07 ppm.
VI. Objections and Hearing Requests
Under section 408(g) of FFDCA, as
amended by FQPA, any person may file
an objection to any aspect of this
regulation and may also request a
hearing on those objections. The EPA
procedural regulations which govern the
submission of objections and requests
for hearings appear in 40 CFR part 178.
Although the procedures in those
regulations require some modification to
reflect the amendments made to FFDCA
by FQPA, EPA will continue to use
those procedures, with appropriate
adjustments, until the necessary
modifications can be made. The new
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sroberts on PROD1PC70 with RULES
section 408(g) of FFDCA provides
essentially the same process for persons
to ‘‘object’’ to a regulation for an
exemption from the requirement of a
tolerance issued by EPA under new
section 408(d) of FFDCA, as was
provided in the old sections 408 and
409 of FFDCA. However, the period for
filing objections is now 60 days, rather
than 30 days.
EPA–HQ–OPP–2004–0398, to: Public
Information and Records Integrity
Branch, Information Technology and
Resources Management Division
(7502C), Office of Pesticide Programs,
Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington,
DC 20460–0001. In person or by courier,
bring a copy to the location of the PIRIB
described in ADDRESSES.
A. What Do I Need to Do to File an
Objection or Request a Hearing?
You must file your objection or
request a hearing on this regulation in
accordance with the instructions
provided in this Unit and in 40 CFR part
178. To ensure proper receipt by EPA,
you must identify docket ID number
EPA–HQ–OPP–2004–0398 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 July 3, 2006.
1. Filing the request. Your objection
must specify the specific provisions in
the regulation that you object to, and the
grounds for the objections (40 CFR
178.25). If a hearing is requested, the
objections must include a statement of
the factual issue(s) on which a hearing
is requested, the requestor’s contentions
on such issues, and a summary of any
evidence relied upon by the objector (40
CFR 178.27). Information submitted in
connection with an objection or hearing
request may be claimed confidential by
marking any part or all of that
information as CBI. Information so
marked will not be disclosed except in
accordance with procedures set forth in
40 CFR part 2. A copy of the
information that does not contain CBI
must be submitted for inclusion in the
public record. Information not marked
confidential may be disclosed publicly
by EPA without prior notice.
Mail your written request to: Office of
the Hearing Clerk (1900L),
Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington,
DC 20460–0001. You may also deliver
your request to the Office of the Hearing
Clerk in Suite 350, 1099 14th St., NW.,
Washington, DC 20005. The Office of
the Hearing Clerk is open from 8 a.m.
to 4 p.m., Monday through Friday,
excluding legal holidays. The telephone
number for the Office of the Hearing
Clerk is (202) 564–6255.
2. Copies for the Docket. In addition
to filing an objection or hearing request
with the Hearing Clerk as described in
Unit VI.A.1., you should also send a
copy of your request to the PIRIB for its
inclusion in the official record that is
described in ADDRESSES. Mail your
copies, identified by docket ID number
B. When Will the Agency Grant a
Request for a Hearing?
A request for a hearing will be granted
if the Administrator determines that the
material submitted shows the following:
There is a genuine and substantial issue
of fact; there is a reasonable possibility
that available evidence identified by the
requestor would, if established resolve
one or more of such issues in favor of
the requestor, taking into account
uncontested claims or facts to the
contrary; and resolution of the factual
issue(s) in the manner sought by the
requestor would be adequate to justify
the action requested (40 CFR 178.32).
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18:14 May 02, 2006
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VII. 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
PO 00000
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25955
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. 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
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Federal Register / Vol. 71, No. 85 / Wednesday, May 3, 2006 / Rules and Regulations
relationship between the Federal
Government and Indian tribes, or on the
distribution of power and
responsibilities between the Federal
Government and Indian tribes, as
specified in Executive Order 13175.
Thus, Executive Order 13175 does not
apply to this rule.
VIII. Congressional Review Act
sroberts on PROD1PC70 with RULES
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).
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 180
[EPA–HQ–OPP–2003–0246; FRL–8064–4]
Boscalid; Pesticide Tolerance
Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:
SUMMARY: This regulation increases the
tolerance for residues of boscalid, 3pyridinecarboxamide, 2-chloro-N-(4’chloro [1,1’-biphenyl]-2-yl) in or on
strawberry; and decreases indirect or
inadvertant tolerances on beet, garden,
roots; beet, sugar, roots; radish, roots;
turnip, roots; and vegetable, root and
tuber, leaves, Group 2. BASF requested
these revised tolerances under the
Federal Food, Drug, and Cosmetic Act
(FFDCA), as amended by the Food
Quality Protection Act (FQPA) of 1996.
DATES: This regulation is effective May
3, 2006. Objections and requests for
hearings must be received on or before
July 3, 2006.
List of Subjects in 40 CFR Part 180
ADDRESSES: To submit a written
Environmental protection,
objection or hearing request follow the
Administrative practice and procedure,
detailed instructions as provided in
Agricultural commodities, Pesticides
Unit VI. of the SUPPLEMENTARY
and pests, Reporting and recordkeeping INFORMATION. EPA has established a
requirements.
docket for this action under Docket
identification (ID) number EPA–HQ–
Dated: April 26, 2006.
OPP–2003–0246. All documents in the
Lois Rossi,
docket are listed on the
Director, Registration Division, Office of
www.regulations.gov web site.
Pesticide Programs.
EDOCKET, EPA’s electronic public
I Therefore, 40 CFR chapter I is
docket and comment system was
amended as follows:
replaced on November 25, 2005, by an
enchanced Federal-wide electronic
PART 180—[AMENDED]
docket management and comment
system located at https://
I 1. The authority citation for part 180
www.regulations.gov. Follow the on-line
continues to read as follows:
instructions. Although listed in the
Authority: 21 U.S.C. 321(q), 346a and 371.
index, some information is not publicly
I 2. Section 180.568 is amended by
available, i.e., CBI or other information
alphabetically adding commodities to
whose disclosure is restricted by statute.
the table in paragraph (a) to read as
Certain other material, such as
follows:
copyrighted material, is not placed on
the Internet and will be publicly
§ 180.568 Flumioxazin; tolerances for
available only in hard copy form.
residues.
Publicly available docket materials are
(a) * * *
available either electronically in
EDOCKET or in hard copy at the Public
Commodity
Parts per million
Information and Records Integrity
Branch (PIRIB), Rm. 119, Crystal Mall
*
*
*
*
*
Fruit, pome, group 11 .....
0.02 #2, 1801 S. Bell St., Arlington, VA. This
Fruit, stone, group 12 .....
0.02 docket facility is open from 8:30 a.m. to
*
*
*
*
*
4 p.m., Monday through Friday,
Strawberry ......................
0.07 excluding legal holidays. The docket
*
*
*
*
*
telephone number is (703) 305–5805.
• Important Note: OPP will be
*
*
*
*
*
moving to a new location the first week
[FR Doc. 06–4159 Filed 5–2–06; 8:45 am]
of May 2006. As a result, from Friday,
BILLING CODE 6560–50–S
April 28 to Friday, May 5, 2006, the
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18:14 May 02, 2006
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OPP Regulatory Public Docket will NOT
be accepting any deliveries at the
Crystal Mall #2 address and this facility
will be closed to the public. Beginning
on May 8, 2006, the OPP Regulatory
Public Docket will reopen at 8:30 a.m.
and deliveries will be accepted in Rm.
S–4400, One Potomac Yard (South
Building), 2777 S. Crystal Drive,
Arlington, VA 22202. The mail code for
the mailing address will change to
(7502P), but will otherwise remain the
same. The OPP Regulatory Public
Docket telephone number and hours of
operation will remain the same after the
move.
FOR FURTHER INFORMATION CONTACT:
Tony Kish, Registration Division
(7505C), Office of Pesticide Programs,
Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington,
DC 20460–0001; telephone number:
(703) 308–9443; e-mail address:
kish.tony@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.
E:\FR\FM\03MYR1.SGM
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Agencies
[Federal Register Volume 71, Number 85 (Wednesday, May 3, 2006)]
[Rules and Regulations]
[Pages 25951-25956]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 06-4159]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2004-0398; FRL-8057-5]
Flumioxazin; Pesticide Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: This regulation establishes tolerances for residues of
flumioxazin, 2-[7-fluoro-3,4-dihydro-3-oxo-4-(2-propynyl)-2H-1,4-
benzoxazin-6-yl]-4,5,6,7-tetrahydro-1H-isoindole-1,3(2H)-dione in or on
pome fruit crop group 11, stone fruit crop group 12 and strawberry.
Valent U.S.A. Corporation requested this tolerance under the Federal
Food, Drug, and Cosmetic Act (FFDCA), as amended by the Food Quality
Protection Act of 1996 (FQPA).
[[Page 25952]]
DATES: This regulation is effective May 3, 2006. Actions and requests
for hearings must be received on or before July 3, 2006.
ADDRESSES: To submit a written objection or hearing request follow the
detailed instructions as provided in Unit VI. of the SUPPLEMENTARY
INFORMATION. EPA has established a docket for this action under Docket
identification (ID) number EPA-HQ-OPP-2004-0398. All documents in the
docket are listed on the regulations.gov Web site. (EDOCKET, EPA's
electronic public docket and comment system was replaced on November
25, 2005, by an enhanced federal-wide electronic docket management and
comment system located at https://www.regulations.gov. Follow the on-
line instructions.) Although listed in the index, some information is
not publicly available, i.e., 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 available only in hard copy form.
Publicly available docket materials are available either electronically
in EDOCKET or in hard copy at the Public Information and Records
Integrity Branch (PIRIB), Rm. 119, Crystal Mall 2, 1801 S.
Bell St., Arlington, VA. This docket facility is open from 8:30 a.m. to
4 p.m., Monday through Friday, excluding legal holidays. The docket
telephone number is (703) 305-5805.
Important Note: OPP will be moving to a new location the
first week of May 2006. As a result, from Friday, April 28 to Friday,
May 5, 2006, the OPP Regulatory Public Docket will NOT be accepting any
deliveries at the Crystal Mall 2 address and this facility
will be closed to the public. Beginning on May 8, 2006, the OPP
Regulatory Public Docket will reopen at 8:30 a.m. and deliveries will
be accepted in Rm. S-4400, One Potomac Yard (South Building), 2777 S.
Crystal Drive, Arlington, VA 22202. The mail code for the mailing
address will change to (7502P), but will otherwise remain the same. The
OPP Regulatory Public Docket telephone number and hours of operation
will remain the same after the move.
FOR FURTHER INFORMATION CONTACT: Joanne I. Miller, Registration
Division (7505C), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001; telephone number: (703) 305-6224; e-mail address:
miller.joanne@epamail.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 and Other
Related Information?
In addition to using EDOCKET (https://www.epa.gov/edocket), you may
access this Federal Register document electronically through the EPA
Internet under the ``Federal Register'' listings at https://www.epa.gov/
fedrgstr. A frequently updated electronic version of 40 CFR part 180 is
available at E-CFR Beta Site Two at https://www.gpoaccess.gov/ecfr. To
access the OPPTS Harmonized Guidelines referenced in this document, go
directly to the guidelines at https://www.epa.gpo/opptsfrs/home/
guidelin.htm.
II. Background and Statutory Findings
In the Federal Register of December 8, 2004 (69 FR 71045) (FRL-
7689-1), 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
4F6829) by Valent U.S.A. Corporation, 1333 North California Boulevard,
Suite 600, Walnut Creek, California 94596-8025. The petition requested
that 40 CFR 180.568 be amended by establishing tolerances for residues
of the herbicide flumioxazin, 2-[7-fluoro-3,4-dihydro-3-oxo-4-(2-
propynyl)-2H-1,4-benzoxazin-6-yl]-4,5,6,7-tetrahydro-1H-isoindole-
1,3(2H)-dione, in or on fruit, pome group 11 at 0.02 parts per million
(ppm) and fruit, stone, group 12 at 0.02 ppm.
In the Federal Register of April 8, 2005 (70 FR 18004) (FRL-7689-
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
4E6845) by Interregional Research Project Number 4 (IR-4), Rutgers,
State University of New Jersey, 681 U.S. Highway 1 S., North
New Brunswick, NJ 08902. The petition requested that 40 CFR 180.568 be
amended by establishing tolerances for residues of the herbicide
flumioxazin, 2-[7-fluoro-3,4-dihydro-3-oxo-4-(2-propynyl)-2H-1,4-
benzoxazin-6-yl]-4,5,6,7-tetrahydro-1H-isoindole-1,3(2H)-dione, in or
on strawberry at 0.10 ppm.
These notices included a summary of the petitions prepared by
Valent U.S.A. Corporation, the registrant and Interregional Research
Project Number 4 (IR-4). Based on residue chemistry strawberry field
trials the strawberry tolerance is being lowered to 0.07 ppm. One
comment was received on the notices of filing. EPA's response to this
comment is discussed in Unit IV.C.
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://
[[Page 25953]]
www.epa.gov/fedrgstr/EPA-PEST/1997/November/Day-26/p30948.htm.
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 tolerances for residues of flumioxazin on
fruit, pome, group 11 at 0.02 ppm, fruit, stone, group 12 at 0.02 ppm,
and strawberry at 0.07 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 flumioxazin as well as the no-observed-
adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-
level (LOAEL) from the toxicity studies are discussed in the Federal
Register of August 25, 2004 (69 FR 52192) (FRL-7369-9).
B. Toxicological Endpoints
A summary of the toxicological endpoints for flumioxazin used for
human risk assessment is discussed in Unit III.B. of the final rule
published in the Federal Register of August 25, 2004 (69 FR 52192)
(FRL-7369-9).
C. Exposure Assessment
1. Dietary exposure from food and feed uses. Tolerances have been
established (40 CFR 180.568) for the residues of flumioxazin, in or on
a variety of raw agricultural commodities. Risk assessments were
conducted by EPA to assess dietary exposures from flumioxazin 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.
In conducting the acute dietary risk assessment EPA used the
Dietary Exposure Evaluation Model software with the Food Commodity
Intake Database (DEEM-FCID\TM\), which incorporates food consumption
data as reported by respondents in the U.S. Department of Agriculture
(USDA) 1994-1996 and 1998 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: For the acute analyses, tolerance-level residues
were assumed for all food commodities with current or proposed
flumioxazin tolerances, and it was assumed that all of the crops
included in the analysis were treated. Percent Crop Treated (PCT) and/
or anticipated residues were not used in the acute risk assessment.
ii. Chronic exposure. In conducting the chronic dietary risk
assessment EPA used the DEEM-FCID\TM\, which incorporates food
consumption data as reported by respondents in the USDA 1994-1996 and
1998 Nationwide CSFII, and accumulated exposure to the chemical for
each commodity. The following assumptions were made for the chronic
exposure assessments: For the chronic analyses, tolerance-level
residues were assumed for all food commodities with current or proposed
flumioxazin tolerances, and it was assumed that all of the crops
included in the analysis were treated. PCT and/or anticipated residues
were not used in the chronic risk assessment.
2. Dietary exposure from drinking water. The Agency lacks
sufficient monitoring exposure data to complete a comprehensive dietary
exposure analysis and risk assessment for flumioxazin and its
degradates (482-HA and APF) 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 flumioxazin and its
degradates (482-HA and APF).
The Agency uses the FQPA Index Reservoir Screening Tool (FIRST) or
the Pesticide Root Zone Model/Exposure Analysis Modeling System (PRZM/
EXAMS), to produce estimates of pesticide concentrations in an index
reservoir. The screening concentration in ground water (SCI-GROW) model
is used to predict pesticide concentrations in shallow ground water.
For a screening-level assessment for surface water EPA will use FIRST
(a Tier 1 model) before using PRZM/EXAMS (a Tier 2 model). The FIRST
model is a subset of the PRZM/EXAMS model that uses a specific high-end
runoff scenario for pesticides. Both FIRST and PRZM/EXAMS incorporate
an index reservoir environment, and both models include a percent crop
area factor as an adjustment to account for the maximum percent crop
coverage within a watershed or drainage basin.
None of these models include consideration of the impact processing
(mixing, dilution, or treatment) of raw water for distribution as
drinking water would likely have on the removal of pesticides from the
source water. The primary use of these models by the Agency at this
stage is to provide a screen for sorting out pesticides for which it is
unlikely that drinking water concentrations would exceed human health
levels of concern.
Since the models used are considered to be screening tools in the
risk assessment process, the Agency uses the estimated environmental
concentrations (EECs), which are the model estimates of a pesticide's
concentration in water. EECs derived from these models are used to
quantify drinking water exposure and risk as a percent reference dose
(%RfD) or percent population adjusted dose (%PAD).
Based on the FIRST and SCI-GROW models, the EECs of flumioxazin and
its degradates (482-HA and APF) for acute exposures are estimated to be
a total of 34 parts per billion (ppb) for surface water and 48 ppb for
ground water. The EECs for chronic exposures are estimated to be a
total of 18 ppb for surface water and 48 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).
Flumioxazin is not registered for use on any sites that would
result in residential exposure.
4. Cumulative effects from substances with a common mechanism of
toxicity. Section 408(b)(2)(D)(v) of the FFDCA requires that, when
considering whether to establish, modify, or revoke a tolerance, the
Agency consider ``available information'' concerning the cumulative
effects of a particular pesticide's residues and ``other substances
that have a common mechanism of toxicity.''
Unlike other pesticides for which EPA has followed a cumulative
risk approach based on a common mechanism of toxicity, EPA has not made
a common mechanism of toxicity finding as to flumioxazin and any other
substances and flumioxazin does not appear to produce a toxic
metabolite produced by other substances. For the purposes of
[[Page 25954]]
this tolerance action, therefore, EPA has not assumed that flumioxazin
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 Web site 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 database 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 (MOE) 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. Although increased prenatal
and postnatal quantitative susceptibility was seen in rats, it was
concluded that there is low concern and no residual uncertainties for
prenatal and/or postnatal toxicity because:
i. Developmental toxicity NOAELs/LOAELs are well characterized
after oral and dermal exposure.
ii. Offspring toxicity NOAEL/LOAEL are well characterized.
iii. There is a well-defined dose-response curve for the
cardiovascular effects seen following oral exposure (i.e., critical
period).
iv. The endpoints of concern are used for overall risk assessments
for appropriate route and population subgroups.
3. Conclusion. There is a complete toxicity database for
flumioxazin and exposure data are complete or are estimated based on
data that reasonably accounts for potential exposures. The
developmental toxicity and offspring toxicity NOAELs/LOAELs are well
characterized. There is a well-defined dose-response curve for the
cardiovascular effects and the endpoints of concern are used for
overall risk assessments and are appropriate for the route of exposure
and population subgroups. The dietary food exposure assessment utilizes
tolerance level residues and 100% crop treated (CT) information for all
commodities. By using these screening-level assumptions, chronic
exposures/risks will not be underestimated. The dietary drinking water
assessment utilizes values generated by models and associated modeling
parameters which are designed to provide conservative, health
protective, high-end estimates of water concentrations. Accordingly,
the additional 10X factor for the protection of infants and children is
removed.
E. Aggregate Risks and Determination of Safety
1. Acute risk. Using the exposure assumptions discussed in this
Unit for acute exposure, the acute dietary exposure from food and
drinking water to flumioxazin will occupy 8% of the acute population
adjusted dose (aPAD) for females 13 to 49 years old (the only subgroup
for which an acute endpoint was selected).
2. Chronic risk. Using the exposure assumptions described in this
Unit for chronic exposure, EPA has concluded that exposure to
flumioxazin from food and drinking water will utilize 6% of the chronic
population adjusted dose (cPAD) for the U.S. population, 18% of the
cPAD for all infants less than 1-year old, and 11% of the cPAD for
children 1-2 years old. There are no residential uses for flumioxazin
that result in chronic residential exposure to flumioxazin.
3. Short-term risk. Short-term aggregate exposure takes into
account residential exposure plus chronic exposure to food and water
(considered to be a background exposure level).
Flumioxazin is not registered for use on any sites that would
result in residential exposure. Therefore, the aggregate risk is the
sum of the risk from food and water, which do not exceed the Agency's
level of concern.
4. 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 flumioxazin residues.
IV. Other Considerations
A. Analytical Enforcement Methodology
Adequate enforcement methodology (gas chromatography-nitrogen
phosphorus detection) is available to enforce the tolerance expression.
The method may be requested 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
There are no Codex, Canadian or Mexican maximum residue limits
established for flumioxazin on fruit, pome, fruit, stone or strawberry.
C. Response to Comments
Public comments were received from B. Sachau who objected to the
proposed tolerances because of the amounts of pesticides already
consumed and carried by the American population. She further indicated
that testing conducted on animals have absolutely no validity and are
cruel to the test animals. B. Sachau's comments contained no scientific
data or evidence to rebut the Agency's conclusion that there is a
reasonable certainty that no harm will result from aggregate exposure
to flumioxazin, including all anticipated dietary exposures and all
other exposures for which there is reliable information. EPA has
responded to B. Sachau's generalized comments on numerous previous
occasions. (70 FR 1349, January 7, 2005); 69 FR 63083, October 29,
2004.
V. Conclusion
Therefore, the tolerance is established for residues of
flumioxazin, 2-[7-fluoro-3,4-dihydro-3-oxo-4-(2-propynyl)-2H-1,4-
benzoxazin-6-yl]-4,5,6,7-tetrahydro-1H-isoindole-1,3(2H)-dione, in or
on fruit, pome, group 11 at 0.02 ppm, fruit, stone, group 12 at 0.02
ppm, and strawberry at 0.07 ppm.
VI. Objections and Hearing Requests
Under section 408(g) of FFDCA, as amended by FQPA, any person may
file an objection to any aspect of this regulation and may also request
a hearing on those objections. The EPA procedural regulations which
govern the submission of objections and requests for hearings appear in
40 CFR part 178. Although the procedures in those regulations require
some modification to reflect the amendments made to FFDCA by FQPA, EPA
will continue to use those procedures, with appropriate adjustments,
until the necessary modifications can be made. The new
[[Page 25955]]
section 408(g) of FFDCA provides essentially the same process for
persons to ``object'' to a regulation for an exemption from the
requirement of a tolerance issued by EPA under new section 408(d) of
FFDCA, as was provided in the old sections 408 and 409 of FFDCA.
However, the period for filing objections is now 60 days, rather than
30 days.
A. What Do I Need to Do to File an Objection or Request a Hearing?
You must file your objection or request a hearing on this
regulation in accordance with the instructions provided in this Unit
and in 40 CFR part 178. To ensure proper receipt by EPA, you must
identify docket ID number EPA-HQ-OPP-2004-0398 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 July 3,
2006.
1. Filing the request. Your objection must specify the specific
provisions in the regulation that you object to, and the grounds for
the objections (40 CFR 178.25). If a hearing is requested, the
objections must include a statement of the factual issue(s) on which a
hearing is requested, the requestor's contentions on such issues, and a
summary of any evidence relied upon by the objector (40 CFR 178.27).
Information submitted in connection with an objection or hearing
request may be claimed confidential by marking any part or all of that
information as CBI. Information so marked will not be disclosed except
in accordance with procedures set forth in 40 CFR part 2. A copy of the
information that does not contain CBI must be submitted for inclusion
in the public record. Information not marked confidential may be
disclosed publicly by EPA without prior notice.
Mail your written request to: Office of the Hearing Clerk (1900L),
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460-0001. You may also deliver your request to the
Office of the Hearing Clerk in Suite 350, 1099 14th St., NW.,
Washington, DC 20005. The Office of the Hearing Clerk is open from 8
a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The
telephone number for the Office of the Hearing Clerk is (202) 564-6255.
2. Copies for the Docket. In addition to filing an objection or
hearing request with the Hearing Clerk as described in Unit VI.A.1.,
you should also send a copy of your request to the PIRIB for its
inclusion in the official record that is described in ADDRESSES. Mail
your copies, identified by docket ID number EPA-HQ-OPP-2004-0398, to:
Public Information and Records Integrity Branch, Information Technology
and Resources Management Division (7502C), Office of Pesticide
Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460-0001. In person or by courier, bring a copy to the
location of the PIRIB described in ADDRESSES.
B. When Will the Agency Grant a Request for a Hearing?
A request for a hearing will be granted if the Administrator
determines that the material submitted shows the following: There is a
genuine and substantial issue of fact; there is a reasonable
possibility that available evidence identified by the requestor would,
if established resolve one or more of such issues in favor of the
requestor, taking into account uncontested claims or facts to the
contrary; and resolution of the factual issue(s) in the manner sought
by the requestor would be adequate to justify the action requested (40
CFR 178.32).
VII. Statutory and Executive Order Reviews
This final rule establishes a tolerance under section 408(d) of
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. 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
[[Page 25956]]
relationship between the Federal Government and Indian tribes, or on
the distribution of power and responsibilities between the Federal
Government and Indian tribes, as specified in Executive Order 13175.
Thus, Executive Order 13175 does not apply to this rule.
VIII. Congressional Review Act
The Congressional Review Act, 5 U.S.C. 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: April 26, 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 180.568 is amended by alphabetically adding commodities to
the table in paragraph (a) to read as follows:
Sec. 180.568 Flumioxazin; tolerances for residues.
(a) * * *
------------------------------------------------------------------------
Commodity Parts per million
------------------------------------------------------------------------
* * * * *
Fruit, pome, group 11................................ 0.02
Fruit, stone, group 12............................... 0.02
* * * * *
Strawberry........................................... 0.07
* * * * *
------------------------------------------------------------------------
* * * * *
[FR Doc. 06-4159 Filed 5-2-06; 8:45 am]
BILLING CODE 6560-50-S