Flumioxazin; Pesticide Tolerances, 39247-39251 [E8-15316]
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Federal Register / Vol. 73, No. 132 / Wednesday, July 9, 2008 / Rules and Regulations
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(b) Section 18 emergency exemption.
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[FR Doc. E8–15517 Filed 7–8–08; 8:45 am]
BILLING CODE 6560–50–S
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 180
[EPA–HQ–OPP–2007–0871; FRL–8370–2]
Flumioxazin; Pesticide Tolerances
Environmental Protection
Agency (EPA).
ACTION: Final rule.
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AGENCY:
SUMMARY: This regulation establishes
tolerances for residues of flumioxazin in
or on corn, field grain; corn, field forage;
and corn, field stover. Valent U.S.A.
Corporation requested these tolerances
under the Federal Food, Drug, and
Cosmetic Act (FFDCA).
DATES: This regulation is effective July
9, 2008. Objections and requests for
hearings must be received on or before
September 8, 2008, 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–2007–0871. To access the
electronic docket, go to https://
www.regulations.gov, select ‘‘Advanced
Search,’’ then ‘‘Docket Search.’’ Insert
the docket ID number where indicated
and select the ‘‘Submit’’ button. Follow
the instructions on the regulations.gov
website to view the docket index or
access available documents. All
documents in the docket are listed in
the docket index available in
regulations.gov. 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
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the Internet and will be publicly
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 Bldg.),
2777 S. Crystal Dr., Arlington, VA. The
Docket Facility is open from 8:30 a.m.
to 4 p.m., Monday through Friday,
excluding legal holidays. The Docket
Facility telephone number is (703) 305–
5805.
FOR FURTHER INFORMATION CONTACT:
Joanne I. Miller, Registration Division
(7505P), 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@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 those engaged in the
following activities:
• Crop production (NAICS code 111).
• Animal production (NAICS code
112).
• Food manufacturing (NAICS code
311).
• Pesticide manufacturing (NAICS
code 32532).
This listing is not intended to be
exhaustive, but rather to provide 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.
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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 EPA’s tolerance
regulations at 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 FFDCA, any
person may file an objection to any
aspect of this regulation and may also
request a hearing on those objections.
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–2007–0871 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
as required by 40 CFR part 178 on or
before September 8, 2008.
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 this copy,
identified by docket ID number EPA–
HQ–OPP–2007–0871, 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.
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• Delivery: OPP Regulatory Public
Docket (7502P), Environmental
Protection Agency, Rm. S–4400, One
Potomac Yard (South Bldg.), 2777 S.
Crystal Dr., 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 Facility telephone number is
(703) 305–5805.
II. Petition for Tolerance
In the Federal Register of September
28, 2007 (72 FR 55204) (FRL–8147–1),
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 7F7243) by Valent
U.S.A. Corporation, 1600 Riviera
Avenue, Suite 200, Walnut Creek, CA
94596. The petition requested that 40
CFR 180.568 be amended by
establishing tolerances for residues of
the herbicide 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
corn, field grain; corn, field forage; and
corn, field stover at 0.02 parts per
million (ppm). That notice referenced a
summary of the petition prepared by
Valent U.S.A. Corporation, the
registrant, which is available to the
public in the docket, https://
www.regulations.gov. There were no
comments received in response to the
notice of filing.
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III. Aggregate Risk Assessment and
Determination of Safety
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....’’
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Consistent with section 408(b)(2)(D)
of FFDCA, and the factors specified in
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 for the petitioned-for
tolerances for residues of flumioxazin
on corn, field grain; corn, field forage;
and corn, field stover at 0.02 ppm.
EPA’s assessment of exposures and risks
associated with establishing tolerances
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.
Flumioxazin has mild or no acute
toxicity when administered orally,
dermally, or by inhalation. It has little
or no toxicity with regard to eye
irritation or skin irritation and is not a
dermal sensitizer. Subchronic and
chronic toxicity studies demonstrated
that the target organs of flumioxazin are
the liver, spleen and cardiovascular
system. Developmental effects were
observed in developmental rat studies.
These effects were fetal cardiovascular
anomalies (especially ventricular septal
defects). Flumioxazin has been
classified as a ‘‘Not Likely Human
Carcinogen,’’ based on the lack of
carcinogenicity in a 2–year rat study, an
18–month mouse study, and a battery of
mutagenic studies.
Specific information on the studies
received and the nature of the adverse
effects caused by flumioxazin as well as
the no-observed-adverse-effect-level
(NOAEL) and the lowest-observedadverse-effect-level (LOAEL) from the
toxicity studies can be found at https://
www.regulations.gov in document
‘‘Flumioxazin; Human Health Risk
Assessment for the Proposed Food Use
on Field Corn,’’ at page 39 in docket ID
number EPA–HQ–OPP–2007–0871.
B. Toxicological Endpoints
For hazards that have a threshold
below which there is no appreciable
risk, a toxicological point of departure
(POD) is identified as the basis for
derivation of reference values for risk
assessment. The POD may be defined as
the NOAEL in the toxicology study
identified as appropriate for use in risk
assessment. However, if a NOAEL
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cannot be determined, the LOAEL or a
Benchmark Dose (BMD) approach is
sometimes used for risk assessment.
Uncertainty/safety factors (UFs) are
used in conjunction with the POD to
take into account 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. Safety is assessed for
acute and chronic dietary risks by
comparing aggregate food and water
exposure to the pesticide to the acute
population adjusted dose (aPAD) and
chronic population adjusted dose
(cPAD). The aPAD and cPAD are
calculated by dividing the POD by all
applicable UFs. Aggregate short-term,
intermediate-term, and chronic-term
risks are evaluated by comparing food,
water, and residential exposure to the
POD to ensure that the margin of
exposure (MOE) called for by the
product of all applicable UFs is not
exceeded. This latter value is referred to
as the Level of Concern (LOC).
For non-threshold risks, the Agency
assumes that any amount of exposure
will lead to some degree of risk. Thus,
the Agency estimates risk in terms of the
probability of an occurrence of the
adverse effect greater than that expected
in a lifetime. For more information on
the general principles EPA uses in risk
characterization and a complete
description of the risk assessment
process, see https://www.epa.gov/
pesticides/factsheets/riskassess.htm.
A summary of the toxicological
endpoints for flumioxazin used for
human risk assessment can be found at
https://www.regulations.gov in document
‘‘Flumioxazin; Human Health Risk
Assessment for the Proposed Food Use
on Field Corn,’’ at page 23 in docket ID
number EPA–HQ–OPP–2007–0871.
C. Exposure Assessment
1. Dietary exposure from food and
feed uses. In evaluating dietary
exposure to flumioxazin, EPA
considered exposure under the
petitioned-for tolerances as well as all
existing flumioxazin tolerances in (40
CFR 180.568). EPA assessed 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. No such effect was identified
for the general population. However,
EPA identified potential acute effects,
e.g., cardiovascular effects in offspring,
for the population subgroup, females 13
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to 49 years. In estimating acute dietary
exposure, EPA used food consumption
information from the U.S. Department of
Agriculture (USDA) 1994–1996
Nationwide Continuing Surveys of Food
Intake by Individuals (CSFII). As to
residue levels in food, EPA assumed all
foods for which there are tolerances
(current and proposed) were treated
(100% crop treated assumption) and
contain tolerance-level residues. Percent
crop treated (PCT) and/or anticipated
residues were not used in the acute risk
assessment.
ii. Chronic exposure. In conducting
the chronic dietary exposure assessment
EPA used the food consumption data
from the USDA 1994–1996 CSFII. As to
residue levels in food, EPA assumed all
foods for which there are tolerances
(current and proposed) were treated
(100 PCT assumption) and contain
tolerance-level residues. Percent crop
treated (PCT) and/or anticipated
residues were not used in the risk
assessment.
iii. Cancer. The Agency has
determined that flumioxazin is ‘‘not
likely to be a human carcinogen’’ based
on the lack of carcinogenicity in a 2–rat
study, an 18 month mouse study, and a
battery of mutagenic studies. Therefore,
a quantitative exposure assessment to
evaluate cancer risk is unnecessary.
2. Dietary exposure from drinking
water. The Agency used screening level
water exposure models in the dietary
exposure analysis and risk assessment
for flumioxazin and its degradates, 482–
HA and APF, in drinking water. These
simulation models take into account
data on the physical, chemical, and fate/
transport characteristics of flumioxazin
and its degradates. Further information
regarding EPA drinking water models
used in pesticide exposure assessment
can be found at https://www.epa.gov/
oppefed1/models/water/index.htm.
Based on the First Index Reservoir
Screening Tool (FIRST), and Screening
Concentration in Ground Water (SCIGROW) models, the estimated drinking
water concentrations (EDWCs) of
flumioxazin for acute exposures are
estimated to be 34 parts per billion
(ppb) for surface water and 48 ppb for
ground water.
The EDWCs for chronic exposures for
non-cancer assessments are estimated to
be 18 ppb for surface water and 48 ppb
for ground water.
Modeled estimates of drinking water
concentrations were directly entered
into the dietary exposure model. For
acute dietary risk assessment, the water
concentration value of 48 ppb was used
to assess the contribution to drinking
water. For chronic dietary risk
assessment, the water concentration of
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value 48 ppb was used to assess the
contribution to drinking 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 any
specific use patterns 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.’’
EPA has not found flumioxazin to
share a common mechanism of toxicity
with any other substances, and
flumioxazin does not appear to produce
a toxic metabolite produced by other
substances. For the purposes of this
tolerance action, therefore, EPA has
assumed that flumioxazin does not have
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 EPA’s website at https://
www.epa.gov/pesticides/cumulative.
D. Safety Factor for Infants and
Children
1. In general. Section 408(b)(2)(c) of
FFDCA provides that EPA shall apply
an additional tenfold (10X) 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. This additional margin of
safety is commonly referred to as the
FQPA safety factor (SF). In applying this
provision, EPA either retains the default
value of 10X, or uses a different
additional safety factor when reliable
data available to EPA support the choice
of a different factor.
2. Prenatal and postnatal sensitivity.
The pre-natal and post-natal toxicity
database for flumioxazin includes the
rat and rabbit developmental toxicity
studies and the 2–generation
reproduction toxicity study in rats.
There is evidence of quantitative
susceptibility following oral and dermal
exposures to rats. Following in utero
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exposures, developmental effects
(cardiovascular anomalies) were seen in
the absence of maternal toxicity. There
is no evidence (quantitative or
qualitative) of susceptibility following
in utero oral exposure in rabbits. No
developmental toxicity was seen at the
highest dose tested (3x the Limit-Dose).
There is quantitative evidence of
susceptibility in the multi-generation
reproduction study where effects in
offspring were seen at doses lower than
those which induced effects in parental
animals.
Although increased pre-natal and
post-natal quantitative susceptibility
was seen in rats, the Agency concluded
that there is a low concern and no
residual uncertainties for pre-natal and/
or post-natal toxicity effects of
flumioxazin because:
i. Developmental toxicity (including
cardiovascular abnormalities) NOAELs
and LOAELs from pre-natal exposure
are well characterized after oral and
dermal exposure,
ii. The off-spring toxicity NOAEL and
LOAEL from post-natal exposure are
well characterized,
iii. The dose selected for risk
assessment is protective of all potential
effects.
3. Conclusion. EPA has determined
that reliable data show the safety of
infants and children would be
adequately protected if the FQPA SF
were reduced to 1X. That decision is
based on the following findings:
i. The toxicity database for
flumioxazin is complete.
ii. There is no indication that
flumioxazin is a neurotoxic chemical
and there is no need for a
developmental neurotoxicity study or
additional UFs to account for
neurotoxicity.
iii. Although there is quantitative
evidence of increased susceptibility in
the pre-natal developmental studies and
post-natal multi-generation study in
rats, EPA did not identify any residual
uncertainties after establishing toxicity
endpoints and traditional UFs to be
used in the risk assessment of
flumioxazin. The degree of concern for
pre-natal and/or post-natal toxicity is
low.
iv. There are no residual uncertainties
identified in the exposure databases.
The dietary food exposure assessments
were performed based on 100 PCT and
tolerance-level residues for all
commodities. EPA made conservative
(protective) assumptions in the ground
water and surface water modeling used
to assess exposure to flumioxazin in
drinking water. EPA used similarly
conservative assumptions to assess post
application exposure of children as well
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as incidental oral exposure of toddlers.
These assessments will not
underestimate the exposure and risks
posed by flumioxazin.
E. Aggregate Risks and Determination of
Safety
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EPA determines whether acute and
chronic pesticide exposures are safe by
comparing aggregate exposure estimates
to the aPAD and cPAD. The aPAD and
cPAD represent the highest safe
exposures, taking into account all
appropriate SFs. EPA calculates the
aPAD and cPAD by dividing the POD by
all applicable UFs. For linear cancer
risks, EPA calculates the probability of
additional cancer cases given the
estimated aggregate exposure. Shortterm, intermediate-term, and chronicterm risks are evaluated by comparing
the estimated aggregate food, water, and
residential exposure to the POD to
ensure that the MOE called for by the
product of all applicable UFs is not
exceeded.
1. Acute risk. Using the exposure
assumptions discussed in this unit for
acute exposure, the acute dietary
exposure from food and water to
flumioxazin will occupy 8% of the
aPAD for (females 13 to 49) the
population group receiving the greatest
exposure.
2. Chronic risk. Using the exposure
assumptions described in this unit for
chronic exposure, EPA has concluded
that chronic exposure to flumioxazin
from food and water will utilize 19% of
the cPAD for (Infants less than 1 year
old) the population group receiving the
greatest exposure. There are no
residential uses for flumioxazin.
3. Short-term risk. Short-term
aggregate exposure takes into account
short-term residential exposure plus
chronic exposure to food and water
(considered to be a background
exposure level).
Flumioxazin is not registered for any
use patterns that would result in
residential exposure. Therefore, the
short-term aggregate risk is the sum of
the risk from exposure to flumioxazin
through food and water and will not be
greater than the chronic aggregate risk.
4. Intermediate-term risk.
Intermediate-term aggregate exposure
takes into account intermediate-term
residential exposure plus chronic
exposure to food and water (considered
to be a background exposure level).
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Flumioxazin is not registered for any
use patterns that would result in
intermediate-term residential exposure.
Therefore, the intermediate-term
aggregate risk is the sum of the risk from
exposure to flumioxazin through food
and water, which has already been
addressed, and will not be greater than
the chronic aggregate risk.
5. 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, or to infants and children
from aggregate exposure to flumioxazin
residues.
IV. Other Considerations
A. Analytical Enforcement Methodology
Adequate enforcement methodology
(gas chromatography/nitrogenphosphorus 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 established or proposed
Canadian, Mexican or Codex maximum
residue levels (MRLs) for residues of
flumioxazin in plant commodities
subject to this action.
V. Conclusion
Therefore, tolerances are 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
corn, field grain; corn, field forage; and
corn, field stover at 0.02 ppm.
VI. Statutory and Executive Order
Reviews
This final rule establishes tolerances
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 final rule
has been exempted from review under
Executive Order 12866, this final rule is
not subject to Executive Order 13211,
Actions Concerning Regulations That
Significantly Affect Energy Supply,
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Distribution, or Use (66 FR 28355, May
22, 2001) or Executive Order 13045,
entitled Protection of Children from
Environmental Health Risks and Safety
Risks (62 FR 19885, April 23, 1997).
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., 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).
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.
This final rule directly regulates
growers, food processors, food handlers,
and food retailers, not States or tribes,
nor does this action alter the
relationships or distribution of power
and responsibilities established by
Congress in the preemption provisions
of section 408(n)(4) of FFDCA. As such,
the Agency has determined that this
action will not have a substantial direct
effect on States or tribal governments,
on the relationship between the national
government and the States or tribal
governments, or on the distribution of
power and responsibilities among the
various levels of government or between
the Federal Government and Indian
tribes. Thus, the Agency has determined
that Executive Order 13132, entitled
Federalism (64 FR 43255, August 10,
1999) and Executive Order 13175,
entitled Consultation and Coordination
with Indian Tribal Governments (65 FR
67249, November 9, 2000) do not apply
to this final rule. In addition, this final
rule does not 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).
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).
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VII. Congressional Review Act
ACTION:
The Congressional Review Act, 5
U.S.C. 801 et seq., generally provides
that before a rule may take effect, the
agency promulgating the rule must
submit a rule report 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).
SUMMARY: This regulation establishes
tolerances for combined residues of
spirotetramat and its metabolites BYI
08330-enol, BYI 08330-ketohydroxy,
BYI08330-enol-, and BYI 08330-monohydroxy, calculated as spirotetramat
equivalents, in or on vegetable, tuberous
and corm, subgroup 1C; potato, flakes;
onion, bulb, subgroup 3A-07; vegetable,
leafy, except brassica, group 4; brassica,
head and stem, subgroup 5A; brassica,
leafy greens, subgroup 5B; vegetable,
fruiting, group 8; vegetable, cucurbit,
group 9; fruit, citrus, group 10; citrus,
oil; fruit, pome, group 11; fruit, stone,
group 12; nut, tree, group 14; almond,
hulls; small fruit vine climbing
subgroup, except fuzzy kiwifruit,
subgroup 13-07F; grape; raisin;
strawberry; hop, dried cones; and for the
combined residues of spirotetramat and
its metabolite BYI 08330-enol,
calculated as spirotetramat equivalents,
in or on milk; and meat, fat, and meat
byproducts of cattle, goat; sheep, and
horse. Bayer CropScience requested
these tolerances under the Federal Food,
Drug, and Cosmetic Act (FFDCA).
DATES: This regulation is effective July
9, 2008. Objections and requests for
hearings must be received on or before
September 8, 2008, and must be filed in
accordance with the instructions
provided in 40 CFR part 178 (see also
Unit I.C. of the SUPPLEMENTARY
INFORMATION).
List of Subjects in 40 CFR Part 180
Environmental protection,
Administrative practice and procedure,
Agricultural commodities, Pesticides
and pests, Reporting and recordkeeping
requirements.
Dated: June 26, 2008
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 180.568 is amended by
alphabetically adding the following
commodities to the table in paragraph
(a) to read as follows:
dwashington3 on PRODPC61 with RULES
I
Final rule.
EPA has established a
docket for this action under docket
identification (ID) number EPA–HQ–
OPP–2007–0475. To access the
§ 180.568 Flumioxazin; tolerances for
electronic docket, go to https://
residues.
www.regulations.gov, select ‘‘Advanced
(a) * * *
Search,’’ then ‘‘Docket Search.’’ Insert
the docket ID number where indicated
Commodity
Parts per million
and select the ‘‘Submit’’ button. Follow
the instructions on the regulations.gov
*
*
*
*
*
Corn, field, forage ...........
0.02 website to view the docket index or
Corn, field, grain .............
0.02 access available documents. All
Corn, field, stover ...........
0.02 documents in the docket are listed in
the docket index available in
*
*
*
*
*
regulations.gov. Although listed in the
*
*
*
*
*
index, some information is not publicly
available, e.g., Confidential Business
[FR Doc. E8–15316 Filed 7–8–08; 8:45 am]
Information (CBI) or other information
BILLING CODE 6560–50–S
whose disclosure is restricted by statute.
Certain other material, such as
copyrighted material, is not placed on
ENVIRONMENTAL PROTECTION
the Internet and will be publicly
AGENCY
available only in hard copy form.
40 CFR Part 180
Publicly available docket materials are
available in the electronic docket at
[EPA–HQ–OPP–2007–0475; FRL–8367–1]
https://www.regulations.gov, or, if only
available in hard copy, at the OPP
Spirotetramat; Pesticide Tolerances
Regulatory Public Docket in Rm. S–
AGENCY: Environmental Protection
4400, One Potomac Yard (South Bldg.),
Agency (EPA).
2777 S. Crystal Dr., Arlington, VA. The
VerDate Aug<31>2005
15:16 Jul 08, 2008
Jkt 214001
ADDRESSES:
PO 00000
Frm 00039
Fmt 4700
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39251
Docket Facility is open from 8:30 a.m.
to 4 p.m., Monday through Friday,
excluding legal holidays. The Docket
Facility telephone number is (703) 305–
5805.
FOR FURTHER INFORMATION CONTACT: Rita
Kumar, Registration Division (7505P),
Office of Pesticide Programs,
Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington,
DC 20460–0001; telephone number:
(703) 308–8291; e-mail address:
kumar.rita@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 those engaged in the
following activities:
• Crop production (NAICS code 111).
• Animal production (NAICS code
112).
• Food manufacturing (NAICS code
311).
• Pesticide manufacturing (NAICS
code 32532).
This listing is not intended to be
exhaustive, but rather to provide 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 EPA’s tolerance
regulations at 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 FFDCA, any
person may file an objection to any
E:\FR\FM\09JYR1.SGM
09JYR1
Agencies
[Federal Register Volume 73, Number 132 (Wednesday, July 9, 2008)]
[Rules and Regulations]
[Pages 39247-39251]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-15316]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2007-0871; FRL-8370-2]
Flumioxazin; Pesticide Tolerances
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: This regulation establishes tolerances for residues of
flumioxazin in or on corn, field grain; corn, field forage; and corn,
field stover. Valent U.S.A. Corporation requested these tolerances
under the Federal Food, Drug, and Cosmetic Act (FFDCA).
DATES: This regulation is effective July 9, 2008. Objections and
requests for hearings must be received on or before September 8, 2008,
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-2007-0871. To access the
electronic docket, go to https://www.regulations.gov, select ``Advanced
Search,'' then ``Docket Search.'' Insert the docket ID number where
indicated and select the ``Submit'' button. Follow the instructions on
the regulations.gov website to view the docket index or access
available documents. All documents in the docket are listed in the
docket index available in regulations.gov. 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 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 Bldg.), 2777 S. Crystal Dr.,
Arlington, VA. The Docket Facility is open from 8:30 a.m. to 4 p.m.,
Monday through Friday, excluding legal holidays. The Docket Facility
telephone number is (703) 305-5805.
FOR FURTHER INFORMATION CONTACT: Joanne I. Miller, Registration
Division (7505P), 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@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 those
engaged in the following activities:
Crop production (NAICS code 111).
Animal production (NAICS code 112).
Food manufacturing (NAICS code 311).
Pesticide manufacturing (NAICS code 32532).
This listing is not intended to be exhaustive, but rather to
provide 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 EPA's tolerance regulations at
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 FFDCA, any person may file an objection to
any aspect of this regulation and may also request a hearing on those
objections. 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-2007-0871 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 as required by 40 CFR part 178 on or
before September 8, 2008.
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 this copy, identified by docket ID number
EPA-HQ-OPP-2007-0871, 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.
[[Page 39248]]
Delivery: OPP Regulatory Public Docket (7502P),
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South
Bldg.), 2777 S. Crystal Dr., 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 Facility telephone number is (703) 305-5805.
II. Petition for Tolerance
In the Federal Register of September 28, 2007 (72 FR 55204) (FRL-
8147-1), 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
7F7243) by Valent U.S.A. Corporation, 1600 Riviera Avenue, Suite 200,
Walnut Creek, CA 94596. 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 corn, field grain; corn, field forage; and corn, field stover at
0.02 parts per million (ppm). That notice referenced a summary of the
petition prepared by Valent U.S.A. Corporation, the registrant, which
is available to the public in the docket, https://www.regulations.gov.
There were no comments received in response to the notice of filing.
III. Aggregate Risk Assessment and Determination of Safety
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....''
Consistent with section 408(b)(2)(D) of FFDCA, and the factors
specified in 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 for the petitioned-for
tolerances for residues of flumioxazin on corn, field grain; corn,
field forage; and corn, field stover at 0.02 ppm. EPA's assessment of
exposures and risks associated with establishing tolerances 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.
Flumioxazin has mild or no acute toxicity when administered orally,
dermally, or by inhalation. It has little or no toxicity with regard to
eye irritation or skin irritation and is not a dermal sensitizer.
Subchronic and chronic toxicity studies demonstrated that the target
organs of flumioxazin are the liver, spleen and cardiovascular system.
Developmental effects were observed in developmental rat studies. These
effects were fetal cardiovascular anomalies (especially ventricular
septal defects). Flumioxazin has been classified as a ``Not Likely
Human Carcinogen,'' based on the lack of carcinogenicity in a 2-year
rat study, an 18-month mouse study, and a battery of mutagenic studies.
Specific information on the studies received and the nature of the
adverse 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 can be found at https://
www.regulations.gov in document ``Flumioxazin; Human Health Risk
Assessment for the Proposed Food Use on Field Corn,'' at page 39 in
docket ID number EPA-HQ-OPP-2007-0871.
B. Toxicological Endpoints
For hazards that have a threshold below which there is no
appreciable risk, a toxicological point of departure (POD) is
identified as the basis for derivation of reference values for risk
assessment. The POD may be defined as the NOAEL in the toxicology study
identified as appropriate for use in risk assessment. However, if a
NOAEL cannot be determined, the LOAEL or a Benchmark Dose (BMD)
approach is sometimes used for risk assessment. Uncertainty/safety
factors (UFs) are used in conjunction with the POD to take into account
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. Safety is assessed for
acute and chronic dietary risks by comparing aggregate food and water
exposure to the pesticide to the acute population adjusted dose (aPAD)
and chronic population adjusted dose (cPAD). The aPAD and cPAD are
calculated by dividing the POD by all applicable UFs. Aggregate short-
term, intermediate-term, and chronic-term risks are evaluated by
comparing food, water, and residential exposure to the POD to ensure
that the margin of exposure (MOE) called for by the product of all
applicable UFs is not exceeded. This latter value is referred to as the
Level of Concern (LOC).
For non-threshold risks, the Agency assumes that any amount of
exposure will lead to some degree of risk. Thus, the Agency estimates
risk in terms of the probability of an occurrence of the adverse effect
greater than that expected in a lifetime. For more information on the
general principles EPA uses in risk characterization and a complete
description of the risk assessment process, see https://www.epa.gov/
pesticides/factsheets/riskassess.htm.
A summary of the toxicological endpoints for flumioxazin used for
human risk assessment can be found at https://www.regulations.gov in
document ``Flumioxazin; Human Health Risk Assessment for the Proposed
Food Use on Field Corn,'' at page 23 in docket ID number EPA-HQ-OPP-
2007-0871.
C. Exposure Assessment
1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to flumioxazin, EPA considered exposure under the petitioned-
for tolerances as well as all existing flumioxazin tolerances in (40
CFR 180.568). EPA assessed 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. No such effect was
identified for the general population. However, EPA identified
potential acute effects, e.g., cardiovascular effects in offspring, for
the population subgroup, females 13
[[Page 39249]]
to 49 years. In estimating acute dietary exposure, EPA used food
consumption information from the U.S. Department of Agriculture (USDA)
1994-1996 Nationwide Continuing Surveys of Food Intake by Individuals
(CSFII). As to residue levels in food, EPA assumed all foods for which
there are tolerances (current and proposed) were treated (100% crop
treated assumption) and contain tolerance-level residues. Percent crop
treated (PCT) and/or anticipated residues were not used in the acute
risk assessment.
ii. Chronic exposure. In conducting the chronic dietary exposure
assessment EPA used the food consumption data from the USDA 1994-1996
CSFII. As to residue levels in food, EPA assumed all foods for which
there are tolerances (current and proposed) were treated (100 PCT
assumption) and contain tolerance-level residues. Percent crop treated
(PCT) and/or anticipated residues were not used in the risk assessment.
iii. Cancer. The Agency has determined that flumioxazin is ``not
likely to be a human carcinogen'' based on the lack of carcinogenicity
in a 2-rat study, an 18 month mouse study, and a battery of mutagenic
studies. Therefore, a quantitative exposure assessment to evaluate
cancer risk is unnecessary.
2. Dietary exposure from drinking water. The Agency used screening
level water exposure models in the dietary exposure analysis and risk
assessment for flumioxazin and its degradates, 482-HA and APF, in
drinking water. These simulation models take into account data on the
physical, chemical, and fate/transport characteristics of flumioxazin
and its degradates. Further information regarding EPA drinking water
models used in pesticide exposure assessment can be found at https://
www.epa.gov/oppefed1/models/water/index.htm.
Based on the First Index Reservoir Screening Tool (FIRST), and
Screening Concentration in Ground Water (SCI-GROW) models, the
estimated drinking water concentrations (EDWCs) of flumioxazin for
acute exposures are estimated to be 34 parts per billion (ppb) for
surface water and 48 ppb for ground water.
The EDWCs for chronic exposures for non-cancer assessments are
estimated to be 18 ppb for surface water and 48 ppb for ground water.
Modeled estimates of drinking water concentrations were directly
entered into the dietary exposure model. For acute dietary risk
assessment, the water concentration value of 48 ppb was used to assess
the contribution to drinking water. For chronic dietary risk
assessment, the water concentration of value 48 ppb was used to assess
the contribution to drinking 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 any specific use patterns 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.''
EPA has not found flumioxazin to share a common mechanism of
toxicity with any other substances, and flumioxazin does not appear to
produce a toxic metabolite produced by other substances. For the
purposes of this tolerance action, therefore, EPA has assumed that
flumioxazin does not have 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 EPA's website at https://
www.epa.gov/pesticides/cumulative.
D. Safety Factor for Infants and Children
1. In general. Section 408(b)(2)(c) of FFDCA provides that EPA
shall apply an additional tenfold (10X) 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. This
additional margin of safety is commonly referred to as the FQPA safety
factor (SF). In applying this provision, EPA either retains the default
value of 10X, or uses a different additional safety factor when
reliable data available to EPA support the choice of a different
factor.
2. Prenatal and postnatal sensitivity. The pre-natal and post-natal
toxicity database for flumioxazin includes the rat and rabbit
developmental toxicity studies and the 2-generation reproduction
toxicity study in rats. There is evidence of quantitative
susceptibility following oral and dermal exposures to rats. Following
in utero exposures, developmental effects (cardiovascular anomalies)
were seen in the absence of maternal toxicity. There is no evidence
(quantitative or qualitative) of susceptibility following in utero oral
exposure in rabbits. No developmental toxicity was seen at the highest
dose tested (3x the Limit-Dose). There is quantitative evidence of
susceptibility in the multi-generation reproduction study where effects
in offspring were seen at doses lower than those which induced effects
in parental animals.
Although increased pre-natal and post-natal quantitative
susceptibility was seen in rats, the Agency concluded that there is a
low concern and no residual uncertainties for pre-natal and/or post-
natal toxicity effects of flumioxazin because:
i. Developmental toxicity (including cardiovascular abnormalities)
NOAELs and LOAELs from pre-natal exposure are well characterized after
oral and dermal exposure,
ii. The off-spring toxicity NOAEL and LOAEL from post-natal
exposure are well characterized,
iii. The dose selected for risk assessment is protective of all
potential effects.
3. Conclusion. EPA has determined that reliable data show the
safety of infants and children would be adequately protected if the
FQPA SF were reduced to 1X. That decision is based on the following
findings:
i. The toxicity database for flumioxazin is complete.
ii. There is no indication that flumioxazin is a neurotoxic
chemical and there is no need for a developmental neurotoxicity study
or additional UFs to account for neurotoxicity.
iii. Although there is quantitative evidence of increased
susceptibility in the pre-natal developmental studies and post-natal
multi-generation study in rats, EPA did not identify any residual
uncertainties after establishing toxicity endpoints and traditional UFs
to be used in the risk assessment of flumioxazin. The degree of concern
for pre-natal and/or post-natal toxicity is low.
iv. There are no residual uncertainties identified in the exposure
databases. The dietary food exposure assessments were performed based
on 100 PCT and tolerance-level residues for all commodities. EPA made
conservative (protective) assumptions in the ground water and surface
water modeling used to assess exposure to flumioxazin in drinking
water. EPA used similarly conservative assumptions to assess post
application exposure of children as well
[[Page 39250]]
as incidental oral exposure of toddlers. These assessments will not
underestimate the exposure and risks posed by flumioxazin.
E. Aggregate Risks and Determination of Safety
EPA determines whether acute and chronic pesticide exposures are
safe by comparing aggregate exposure estimates to the aPAD and cPAD.
The aPAD and cPAD represent the highest safe exposures, taking into
account all appropriate SFs. EPA calculates the aPAD and cPAD by
dividing the POD by all applicable UFs. For linear cancer risks, EPA
calculates the probability of additional cancer cases given the
estimated aggregate exposure. Short-term, intermediate-term, and
chronic-term risks are evaluated by comparing the estimated aggregate
food, water, and residential exposure to the POD to ensure that the MOE
called for by the product of all applicable UFs is not exceeded.
1. Acute risk. Using the exposure assumptions discussed in this
unit for acute exposure, the acute dietary exposure from food and water
to flumioxazin will occupy 8% of the aPAD for (females 13 to 49) the
population group receiving the greatest exposure.
2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that chronic exposure to
flumioxazin from food and water will utilize 19% of the cPAD for
(Infants less than 1 year old) the population group receiving the
greatest exposure. There are no residential uses for flumioxazin.
3. Short-term risk. Short-term aggregate exposure takes into
account short-term residential exposure plus chronic exposure to food
and water (considered to be a background exposure level).
Flumioxazin is not registered for any use patterns that would
result in residential exposure. Therefore, the short-term aggregate
risk is the sum of the risk from exposure to flumioxazin through food
and water and will not be greater than the chronic aggregate risk.
4. Intermediate-term risk. Intermediate-term aggregate exposure
takes into account intermediate-term residential exposure plus chronic
exposure to food and water (considered to be a background exposure
level).
Flumioxazin is not registered for any use patterns that would
result in intermediate-term residential exposure. Therefore, the
intermediate-term aggregate risk is the sum of the risk from exposure
to flumioxazin through food and water, which has already been
addressed, and will not be greater than the chronic aggregate risk.
5. 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, or 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 established or proposed Canadian, Mexican or Codex
maximum residue levels (MRLs) for residues of flumioxazin in plant
commodities subject to this action.
V. Conclusion
Therefore, tolerances are 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 corn, field
grain; corn, field forage; and corn, field stover at 0.02 ppm.
VI. Statutory and Executive Order Reviews
This final rule establishes tolerances 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 final rule has been
exempted from review under Executive Order 12866, this final 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) or Executive Order 13045, entitled Protection of
Children from Environmental Health Risks and Safety Risks (62 FR 19885,
April 23, 1997). 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., 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).
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.
This final rule directly regulates growers, food processors, food
handlers, and food retailers, not States or tribes, nor does this
action alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of section 408(n)(4) of FFDCA. As such, the Agency has determined that
this action will not have a substantial direct effect on States or
tribal governments, on the relationship between the national government
and the States or tribal governments, or on the distribution of power
and responsibilities among the various levels of government or between
the Federal Government and Indian tribes. Thus, the Agency has
determined that Executive Order 13132, entitled Federalism (64 FR
43255, August 10, 1999) and Executive Order 13175, entitled
Consultation and Coordination with Indian Tribal Governments (65 FR
67249, November 9, 2000) do not apply to this final rule. In addition,
this final rule does not 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).
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).
[[Page 39251]]
VII. Congressional Review Act
The Congressional Review Act, 5 U.S.C. 801 et seq., generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report 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: June 26, 2008
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 the following
commodities to the table in paragraph (a) to read as follows:
Sec. 180.568 Flumioxazin; tolerances for residues.
(a) * * *
------------------------------------------------------------------------
Commodity Parts per million
------------------------------------------------------------------------
* * * * *
Corn, field, forage.................................. 0.02
Corn, field, grain................................... 0.02
Corn, field, stover.................................. 0.02
* * * * *
------------------------------------------------------------------------
* * * * *
[FR Doc. E8-15316 Filed 7-8-08; 8:45 am]
BILLING CODE 6560-50-S