[Federal Register: August 29, 2007 (Volume 72, Number 167)]
[Rules and Regulations]
[Page 49654-49660]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr29au07-4]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2007-0428; FRL-8138-6]
Flusilazole; Pesticide Tolerances for Emergency Exemptions
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: This regulation establishes time-limited tolerances for
residues of flusilazole in or on soybean seed, soybean aspirated grain
fractions, and soybean oil. This action is in response to EPA's
granting of emergency exemptions under section 18 of the Federal
Insecticide, Fungicide, and Rodenticide Act (FIFRA) authorizing use of
the pesticide on soybeans. This regulation establishes maximum
permissible levels for residues of flusilazole in these food
commodities. The tolerances expire and are revoked on December 31,
2010.
DATES: This regulation is effective August 29, 2007. Objections and
requests for hearings must be received on or before October 29, 2007,
and must be filed in accordance with the instructions provided in 40
CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).
ADDRESSES: EPA has established a docket for this action under docket
identification (ID) number EPA-HQ-OPP-2007-0428. To access the
electronic docket, go to http://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 web site 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 either in the electronic docket at http://www.regulations.gov
, or, if only available in hard copy, at the Office
of Pesticide Programs (OPP) Regulatory Public Docket in Rm. S-4400, One
Potomac Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The
hours of operation of this Docket Facility are 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: Andrea Conrath, Registration Division
(7505P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone
number: (703) 308-9356; e-mail address: conrath.andrea@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 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 provides
a guide for readers regarding entities likely to be affected by this
action. Other types of entities not listed in this unit could also be
affected. The North American Industrial Classification System (NAICS)
codes have been provided to assist you and others in determining
whether this action might apply to certain entities. If you have any
questions regarding the applicability of this action to a particular
entity, consult the person listed under FOR FURTHER INFORMATION
CONTACT.
B. How Can I Access Electronic Copies of this Document?
In addition to accessing an electronic copy of this Federal
Register document through the electronic docket at http://www.regulations.gov
, you may access this Federal Register document
electronically through the EPA Internet under the ``Federal Register''
listings at http://www.epa.gov/fedrgstr. You may
[[Page 49655]]
also access a frequently updated electronic version of 40 CFR part 180
through the Government Printing Office's pilot e-CFR site at http://www.gpoaccess.gov/ecfr
.
C. Can I File an Objection or Hearing Request?
Under section 408(g) of the FFDCA, as amended by the FQPA, any
person may file an objection to any aspect of this regulation and may
also request a hearing on those objections. The EPA procedural
regulations which govern the submission of objections and requests for
hearings appear in 40 CFR part 178. You must file your objection or
request a hearing on this regulation in accordance with the
instructions provided in 40 CFR part 178. To ensure proper receipt by
EPA, you must identify docket ID number EPA-HQ-OPP-2007-0428 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 October 29, 2007.
In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing that does not contain any CBI for inclusion in the public
docket that is described in ADDRESSES. Information not marked
confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA
without prior notice. Submit your copies, identified by docket ID
number EPA-HQ-OPP-2007-0428, by one of the following methods:
Federal eRulemaking Portal: http://www.regulations.gov.
Follow the on-line instructions for submitting comments.
Mail: Office of Pesticide Programs (OPP) Regulatory Public
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460-0001.
Delivery: OPP Regulatory Public Docket (7502P),
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South
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. Background and Statutory Findings
EPA, on its own initiative, in accordance with sections 408(e) and
408(l)(6) of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21
U.S.C. 346a, is establishing tolerances for residues of the fungicide
flusilazole, (1-[[bis(4-fluorophenyl)methylsilyl]methyl]-1H-1,2,4-
triazole), in or on soybean seed at 0.04 parts per million (ppm),
soybean aspirated grain fractions at 2.6 ppm, and soybean oil at 0.10
ppm. These tolerances expire and are revoked on December 31, 2010. EPA
will publish a document in the Federal Register to remove the revoked
tolerances from the Code of Federal Regulations (CFR).
Section 408(l)(6) of the FFDCA requires EPA to establish a time-
limited tolerance or exemption from the requirement for a tolerance for
pesticide chemical residues in food that will result from the use of a
pesticide under an emergency exemption granted by EPA under section 18
of FIFRA. Such tolerances can be established without providing notice
or period for public comment. EPA does not intend for its actions on
section 18 related tolerances to set binding precedents for the
application of section 408 of the FFDCA and the new safety standard to
other tolerances and exemptions. Section 408(e) of the FFDCA allows EPA
to establish a tolerance or an exemption from the requirement of a
tolerance on its own initiative, i.e., without having received any
petition from an outside party.
Section 408(b)(2)(A)(i) of the 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 the 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 the 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. . .
.''
Section 18 of the FIFRA authorizes EPA to exempt any Federal or
State agency from any provision of FIFRA, if EPA determines that
``emergency conditions exist which require such exemption.'' This
provision was not amended by the Food Quality Protection Act of 1996
(FQPA). EPA has established regulations governing such emergency
exemptions in 40 CFR part 166.
III. Emergency Exemption for Flusilazole on Soybeans and FFDCA
Tolerances
Australasian soybean rust (SBR) is a plant disease caused by 2
fungal species, Phakopsora pachyrhizi and P. meibomiae, and is spread
primarily by windborne spores that can be transported over long
distances. SBR models suggest that most of the soybean acreage in the
U.S. could be compromised by an SBR epidemic. In accordance with the
2002 Agricultural Bioterrorism Protection Act, SBR was identified by
the United Stated Department of Agriculture (USDA) as a select
biological agent with the potential to pose a severe threat to the
soybean industry and livestock production, in general. As such, USDA
has invested in extensive readiness and outreach activities among
soybean producers. EPA has authorized under FIFRA section 18 the use of
flusilazole on soybeans for control of Australasian Soybean Rust in
Minnesota and South Dakota. After having reviewed the states'
submissions, EPA concurs that emergency conditions exist for these
States.
As part of its assessment of these emergency exemptions, EPA
assessed the potential risks presented by residues of flusilazole in or
on soybean seed, aspirated grain fractions, and oil. In doing so, EPA
considered the safety standard in section 408(b)(2) of the FFDCA, and
EPA decided that the necessary tolerances under section 408(l)(6) of
the FFDCA would be consistent with the safety standard and with FIFRA
section 18. Consistent with the need to move quickly on the emergency
exemption in order to address an urgent non-routine situation and to
ensure that the resulting food is safe and lawful, EPA is issuing these
tolerances without notice and opportunity for public comment as
provided in section 408(l)(6) of the FFDCA. Although these tolerances
expire and are revoked on December 31, 2010, under section 408(l)(5) of
the FFDCA, residues of the pesticide not in excess of the amounts
specified in the tolerances remaining in or on soybean seed, aspirated
grain fractions, and oil after that date will not be unlawful, provided
the pesticide is applied in a manner that was lawful under FIFRA, and
the residues do not exceed levels that were authorized by these
tolerances at the time of that application. EPA will take action to
revoke these tolerances earlier if any experience with, scientific data
on, or other relevant information on this pesticide indicate that the
residues are not safe.
[[Page 49656]]
Because these tolerances are being approved under emergency
conditions, EPA has not made any decisions about whether flusilazole
meets EPA's registration requirements for use on soybean or whether
permanent tolerances for this use would be appropriate. Under these
circumstances, EPA does not believe that these tolerances serve as the
basis for registration of flusilazole by a State for special local
needs under FIFRA section 24(c). Nor do these tolerances serve as the
basis for use of this pesticide on this crop under section 18 of FIFRA
by any State other than those following all provisions of EPA's
regulations implementing FIFRA section 18 as identified in 40 CFR part
166. For additional information regarding the emergency exemption for
flusilazole, contact the Agency's Registration Division at the address
provided under FOR FURTHER INFORMATION CONTACT.
IV. Aggregate Risk Assessment and Determination of Safety
EPA performs a number of analyses to determine the risks from
aggregate exposure to pesticide residues. For further discussion of the
regulatory requirements of section 408 of the FFDCA and a complete
description of the risk assessment process, see http://www.epa.gov/fedrgstr/EPA-PEST/1997/November/Day-26/p30948.htm
.
Consistent with section 408(b)(2)(D) of the 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
flusilazole and to make a determination on aggregate exposure,
consistent with section 408(b)(2) of the FFDCA, for time-limited
tolerances for residues of flusilazole in or on soybean seed at 0.04
ppm, soybean aspirated grain fractions at 2.6 ppm, and soybean oil at
0.10 ppm. EPA's assessment of the dietary exposures and risks
associated with establishing the tolerances follows.
A. Toxicological Endpoints
The dose at which no adverse effects are observed (the NOAEL) from
the toxicology study identified as appropriate for use in risk
assessment is used to estimate the toxicological endpoint. However, the
lowest dose at which adverse effects of concern are identified (the
LOAEL) is sometimes used for risk assessment if no NOAEL was achieved
in the toxicology study selected. An uncertainty factor (UF) is applied
to reflect uncertainties inherent in the extrapolation from laboratory
animal data to humans and in the variations in sensitivity among
members of the human population as well as other unknowns. An UF of 100
is routinely used, 10X to account for interspecies differences and 10X
for intraspecies differences.
For dietary risk assessment (other than cancer) the Agency uses the
UF to calculate an acute or chronic reference dose (acute RfD or
chronic RfD) where the RfD is equal to the NOAEL divided by the
appropriate UF (RfD = NOAEL/UF). Where an additional safety factor is
applied in order to protect infants and children, this additional
factor is applied to the RfD by dividing the RfD by such additional
factor. The acute or chronic Population Adjusted Dose (aPAD or cPAD) is
a modification of the RfD to accommodate this type of FQPA SF.
For non-dietary risk assessments (other than cancer) the UF is used
to determine the level of concern (LOC). For example, when 100 is the
appropriate UF (10X to account for interspecies differences and 10X for
intraspecies differences) the LOC is 100. To estimate risk, a ratio of
the NOAEL to exposures (margin of exposure (MOE) = NOAEL/exposure) is
calculated and compared to the LOC.
The linear default risk methodology (Q*) is the primary method
currently used by the Agency to quantify carcinogenic risk. The Q*
approach assumes that any amount of exposure will lead to some degree
of cancer risk. A Q* is calculated and used to estimate risk which
represents a probability of occurrence of additional cancer cases
(e.g., risk is expressed as 1 x 10\6\ or one in a million). Under
certain specific circumstances, MOE calculations will be used for the
carcinogenic risk assessment. In this non-linear approach, a ``point of
departure'' is identified below which carcinogenic effects are not
expected. The point of departure is typically a NOAEL based on an
endpoint related to cancer effects though it may be a different value
derived from the dose response curve. To estimate risk, a ratio of the
point of departure to exposure (MOEcancer = point of
departure/exposures) is calculated.
A summary of the toxicological endpoints for flusilazole used for
human risk assessment is discussed in Table 2.3 on page 15 of the human
health risk assessment found at http://www.regulations.gov Docket No.
EPA-HQ-OPP-2007-0428-0001.
B. Exposure Assessment
1. Dietary exposure from food and feed uses. There are currently no
tolerances established for this chemical, and it is not registered in
the US. Risk assessments were conducted by EPA to assess dietary
exposures from flusilazole in food as follows:
i. Acute exposure. Acute dietary 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 one day
or single exposure. EPA used the Dietary Exposure Evaluation Model
(DEEM\TM\) and data on individual food consumption as reported by
respondents in the USDA 1994-1996 and 1998 nationwide Continuing
Surveys of Food Intake by Individuals (CSFII) to estimate exposure to
the chemical for each commodity. This acute risk assessment used
conservative and high end assumptions to estimate acute exposure and
risk, as follows: It was assumed that flusilazole residues in soybean
commodities would be at proposed tolerance levels or higher; default
processing factors were applied to account for effects that may occur
on flusilazole residues from processing into soybean oil; an additional
factor was incorporated to account for potential residues of the
metabolite of flusilazole, which may occur in soybean commodities; and
it was assumed that 100% of the soybean crop grown in the US would be
treated. No refinements such as incorporating anticipated residue
values or percent of crop treated (PCT) assumptions were used. A high-
end estimate for contribution to dietary exposure from residues
occurring in drinking water, was incorporated directly into the dietary
assessment using the 30-year average annual concentration for surface
water generated by the Agency's computer simulation, the Pesticide Root
Zone/Exposure Analysis Modeling System (PRZM-EXAMS).
ii. Chronic exposure. In conducting this chronic dietary risk
assessment EPA used the DEEM\TM\ and data on individual food
consumption as reported by respondents in the USDA 1994-1996 and 1998
nationwide CSFII to estimate exposure to the chemical for each
commodity. The chronic risk assessment also used the same conservative
and high-end assumptions as described above in Unit IV.B.1.i., for
calculation of the acute exposure estimates and risk.
iii. Cancer. The cancer risk assessment incorporated the same
dietary exposure estimates as used for the chronic assessment, and used
conservative and high-end assumptions to calculate cancer risk
estimates over a lifetime of exposure, as described above in Unit
IV.B.1.i.
2. Dietary exposure from drinking water. Since this exemption is
the only use of a new pesticide in the US, there
[[Page 49657]]
are no residues in drinking water, and thus there are no monitoring
exposure data to use for a comprehensive dietary exposure analysis and
risk assessment for flusilazole in drinking water. Because of this, the
Agency calculated drinking water concentration estimates which may
occur from this use, by reliance on simulation or modeling taking into
account data on the physical characteristics of flusilazole.
None of the 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 coarse screen for sorting out pesticides for
which it is highly unlikely that drinking water concentrations would
ever exceed human health LOC.
Based on available data, and for this section 18 use only, the
Agency determined that the residue of concern for drinking water is
flusilazole per se. Some surface and ground water contamination may
occur based on the proposed application rates and the environmental
fate properties of flusilazole, although mobility in soil is expected
to be low.
Based on Tier II screening-level surface water modeling for
drinking water, the Agency estimated concentrations in surface water to
be used for acute, chronic non-cancer, and cancer exposure assessment.
Tier II surface water concentrations for parent flusilazole were
calculated using PRZM-EXAMS. PRZM/EXAMS incorporates an index reservoir
environment and includes a percent crop area factor as an adjustment to
account for the maximum percent crop coverage within a watershed or
drainage basin. EPA used the Screening Concentration Ground Water (SCI-
GROW2) model to estimate ground water concentrations. These results for
both surface and ground water are consistent with the fate and
transport properties of flusilazole.
Modeled estimates of drinking water concentrations were
incorporated directly into the dietary assessments using the estimated
drinking water concentrations (EDWC) for surface water generated by the
PRZM-EXAMS model. For the acute assessment, the peak concentration of
1.81 parts per billion (ppb) was used to assess the contribution to
surface drinking water; for the chronic assessment, the annual mean
value of 0.92 ppb was used to assess the contribution to surface
drinking water. The EDWC for groundwater was estimated by SCI-GROW2 at
0.05 ppb. Since the EDWC estimated by SCI-GROW2 for groundwater was
lower, at 0.05 ppb, the higher, more conservative, surface water
estimate of 1.81 ppb was used for assessing contribution to dietary
exposures.
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). Flusilazole 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.''
Flusilazole is a member of the triazole-containing class of
pesticides. Although triazole pesticides act similarly in plants
(fungi) by inhibiting ergosterol biosynthesis, there is not necessarily
a relationship between this pesticidal activity and their mechanism of
toxicity in mammals. Structural similarities do not constitute a common
mechanism of toxicity. Evidence is needed to establish that the
chemicals operate by the same, or essentially the same sequence of
major biochemical events (EPA, 2002). In triazoles a variable pattern
of toxicological responses is found. Some are hepatotoxic and
hepatocarcinogenic in mice. Some induce thyroid tumors in rats. Some
induce developmental, reproductive, and neurological effects in
rodents. Furthermore, the triazoles produce a diverse range of
biochemical events including altered cholesterol levels, stress
responses, and altered DNA methylation. It is not clearly understood
whether these biochemical events are directly connected to their
toxicological outcomes. Thus, there is currently no evidence to
indicate that triazoles share common mechanisms of toxicity and EPA is
not following a cumulative risk approach based on a common mechanism of
toxicity for the triazole pesticides. For information regarding EPA's
procedures for cumulating effects from substances found to have a
common mechanism of toxicity, see EPA's website at http://www.epa.gov/pesticides/cumulative
.
Flusilazole is a triazole-derived pesticide. This class of
compounds can form the common metabolites 1,2,4-triazole conjugates
(triazole alanine and triazole acetic acid). To support existing
tolerances and to establish new tolerances for triazole-derived
pesticides, EPA conducted a human health risk assessment for exposure
to 1,2,4-triazole, triazole alanine, and triazole acetic acid resulting
from the use of all current and pending uses of any triazole-derived
fungicide. The risk assessment is highly conservative, screening-level
evaluation in terms of hazards associated with common metabolites
(e.g., use of a maximum combination of uncertainty factors) and
potential dietary and non-dietary exposures (i.e., high end estimates
of both dietary and non-dietary exposures). In addition, on the
assessment involving the 1,2,4-triazole metabolites, the Agency
retained the additional 10X FQPA safety factor for the protection of
infants and children. The assessment includes evaluations of risks for
various subgroups, including those comprised of infants and children.
The Agency's complete risk assessment may be found at http://www.epa.gov/opprd001/factsheets/tetraHHRA.pdf
.
In that risk assessment, EPA concluded that, based upon the
available information and on conservative estimates of hazard and
exposure, there are no human health risk issues associated with 1,2,4-
triazole or its metabolites that would preclude re-registration of the
triazole-derivative fungicides registered to date or conditional
registrations of the triazole-derivative fungicides that have been
proposed as of September 1, 2005, which included the use of flusilazole
on soybean.
C. Safety Factor for Infants and Children
1. In general. Section 408 of the FFDCA provides that EPA shall
apply an additional tenfold margin of safety for infants and children
in the case of threshold effects to account for prenatal and postnatal
toxicity and the completeness of the data base on toxicity and exposure
unless EPA determines 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 MOE analysis or
through using uncertainty (safety) factors in calculating a dose level
that poses no appreciable risk to humans.
2. Developmental and Reproductive toxicity studies. There are
several developmental and 2-generation reproduction studies in rats and
rabbits that provide evidence of increased susceptibility to in utero
and/or pre-, postnatal exposure to flusilazole.
[[Page 49658]]
Developmental effects such as cleft palate, resorption and skeletal
malformations were observed in rats. In rabbits, increased resorptions
were observed. In both species, these effects occurred either in the
absence of maternal toxicity and/or at a dose that caused only marginal
maternal toxicity (decreased food consumption, body weight gain). In a
multi-generation reproduction study in rats a decrease in pup viability
at birth and decreased post-natal survival were observed either in the
absence of maternal toxicity and/or at a dose that caused only marginal
maternal toxicity.
3. Prenatal and postnatal sensitivity. The evidence of increased
susceptibility observed in rats and rabbits is off-set because EPA has
set the acute (0.02 milligrams/kilograms (mg/kg) and chronic (0.002 mg/
kg) RfDs below the dose at which these developmental effects were
observed, and these are therefore protective with respect to these
effects. Although NOAELs were not identified in some developmental and
2-generation reproduction studies, there are well established NOAELs in
most of the developmental and 2-generation reproduction studies, and
the RfDs are below these NOAELs. Because EPA has set the RfDs well
below the levels at which developmental effects are observed, the
increased susceptibility seen in these studies does not warrant
retaining the 10X FQPA safety factor (i.e., it is 1X).
4. Conclusion. For the purpose of this emergency quarantine
exemption, EPA relied on studies reviewed by the European Union as well
as some preliminary internal study reviews. Therefore, the stated
toxicological endpoints are applicable for this emergency section 18
use only, since upon detailed review of the new and existing data, the
final conclusions may change. EPA determined that, in terms of hazard,
there are low concerns and no residual uncertainties with regard to
pre-and/or post-natal toxicity. EPA determined that the FQPA 10X safety
factor to protect infants and children should be removed (reduced to
1X) based on the following:
i. The toxicity database for flusilazole is complete.
ii.The dietary food exposure assessment utilizes proposed
tolerance-level or higher residues and 100% CT information for all
commodities. By using these screening-level assessments, acute and
chronic exposures/risks will not be underestimated.
iii.The dietary drinking water assessment (Tier 2 estimates)
utilizes values generated by model and associated modeling parameters
which are designed to provide conservative, health-protective, high-end
estimates of water concentrations.
iv.There are no residential uses of flusilazole.
D. Aggregate Risks and Determination of Safety
The Agency currently has two ways to estimate total aggregate
exposure to a pesticide from food, drinking water, and residential
uses. First, a screening assessment can be used, in which the Agency
calculates drinking water levels of comparison (DWLOCs), which are used
as a point of comparison against estimated drinking water
concentrations (EDWCs). The DWLOC values are not regulatory standards
for drinking water, but are theoretical upper limits on a pesticide's
concentration in drinking water in light of total aggregate exposure to
a pesticide in food and residential uses. More information on the use
of DWLOCs in dietary aggregate risk assessments can be found at http:/www.epa.gov/oppfead1/trac/science/screeningsop.pdf
.
More recently, the Agency has used another approach to estimate
aggregate exposure through food, residential and drinking water
pathways. In this approach, modeled surface water and ground water
EDWCs are directly incorporated into the dietary exposure analysis,
along with food. This approach provides a more realistic estimate of
exposure because actual body weights and water exposures are then added
to estimates and water consumption from the CSFII are used. The
combined food and water exposures are then added to estimated exposure
from residential sources to calculate aggregate risks. The resulting
exposure and risk estimates are still considered to be high end, due to
the assumptions used in developing drinking water modeling inputs. The
risk assessment for flusilazole used in this tolerance document uses
this approach of incorporating water exposure directly in to the
dietary exposure analysis.
There are no registered or proposed uses of flusilazole, which
result in residential exposures, so the aggregate exposure assessment
required by FFDCA section 408(b)(2)(D)(vi) consists solely of dietary
(food + drinking water) exposures.
Aggregate exposure risk assessments were conducted by incorporating
the drinking water concentrations directly into the dietary exposure
assessment for the acute and chronic aggregate exposures (food +
drinking water). These aggregate exposures do not exceed the Agency's
LOC since they were less than 100% of the acute and chronic population
adjusted doses (PADs).
1. Acute risk. Using the exposure assumptions discussed in this
unit for acute exposure, the acute dietary exposure from food and
drinking water to flusilazole is estimated at 0.000326 mg/kg/day, and
occupies 1.6% of the aPAD for females 13-49 years, the population
subgroup of concern. There were no acute toxicity concerns for other
population subgroups noted, based upon the available toxicology
studies, and therefore, no acute toxicology endpoints assigned.
Therefore, EPA does not expect aggregate dietary exposure for this
population subgroup of concern to exceed the LOC of 100% of the aPAD.
2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that exposure to
flusilazole from food and water will utilize 8.1% of the cPAD for the
U.S. population, 21% of the cPAD for All Infants < 1 year old (the most
highly exposed subpopulation), and 17% of the cPAD for Children 1-2
years old, and Children 3-5 years old (both subgroups). Flusilazole is
unregistered, and therefore there are no residential uses or exposures.
EPA does not expect the aggregate exposure to exceed 100% of the cPAD,
as shown in the following Table of this unit:
Aggregate Risk Assessment for Chronic (Non-Cancer) Dietary (Food + Water) Exposure to Flusilazole
----------------------------------------------------------------------------------------------------------------
Population Subgroup Dietary exposure (mg/kg/day) % cPAD utilized
----------------------------------------------------------------------------------------------------------------
General U.S. Population.................................. 0.000162 8.1
----------------------------------------------------------------------------------------------------------------
All Infants (< 1 year old)............................... 0.000429 21
----------------------------------------------------------------------------------------------------------------
Children 1-2 years old................................... 0.000334 17
----------------------------------------------------------------------------------------------------------------
[[Page 49659]]
Children 3-5 years old................................... 0.000338 17
----------------------------------------------------------------------------------------------------------------
Children 6-12 years old.................................. 0.000243 12
----------------------------------------------------------------------------------------------------------------
Youth 13-19 years old.................................... 0.000161 8.0
----------------------------------------------------------------------------------------------------------------
Adults 20-49 years old................................... 0.000143 6.7
----------------------------------------------------------------------------------------------------------------
Adults 50+ years old..................................... 0.000110 5.5
----------------------------------------------------------------------------------------------------------------
Females 13-49 years old 0.000128 6.4
----------------------------------------------------------------------------------------------------------------
3. Short-term and intermediate risks. Short-term and intermediate
aggregate exposures take into account residential exposure plus chronic
exposure to food and water (considered to be a background exposure
level). Flusilazole 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 were previously addressed.
4. Aggregate cancer risk for U.S. population. In its cancer
analysis, EPA assumed 100% of the soybean crop in the US would be
treated with flusilazole. EPA used the DEEM 7.81 default processing
factors to estimate residues that might occur in processed commodities
(i.e. soybean oil) and assumed that flusilazole residues in or on
soybean commodities would be equal to the proposed tolerance levels.
Drinking water was incorporated directly into the dietary assessment
using the 30-year average annual concentration for surface water
generated by the PRZM-EXAMS model as a high-end estimate. The resulting
cancer risk estimate for the general U.S. population (4.5 x
10-\7\) was less than EPA's LOC (generally 1 x
10-\6\).
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, and to infants and children from aggregate
exposure to flusilazole residues.
V. Other Considerations
A. Analytical Enforcement Methodology
Adequate enforcement methodologies (gas chromatography/nitrogen-
phosphorus detector; and gas chromatography/mass-selective detector)
are available to enforce the tolerance expression. The methods 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
(MRLs) for the residues of flusilazole on soybean commodities.
Therefore, there are no international harmonization concerns at this
time.
VI. Conclusion
Therefore, the tolerances are established for residues of
flusilazole, (1-[[bis(4-fluorophenyl)methylsilyl]methyl]-1H-1,2,4-
triazole), in or on soybean seed at 0.04 parts per million (ppm),
soybean aspirated grain fractions at 2.6 ppm, and soybean oil at 0.10
ppm.
VII. 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 rule has been
exempted from review under Executive Order 12866, 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) 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 tolerances 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 6,
2000) do not apply to this rule. In addition, This 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).
VIII. Congressional Review Act
The Congressional Review Act, 5 U.S.C. 801 et seq., generally
provides
[[Page 49660]]
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: August 22, 2007.
Martha Monell,
Acting Director, 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 180.630 is added to read as follows:
Sec. 180.630 Flusilazole; tolerances for residues.
(a) General. [Reserved]
(b) Section 18 emergency exemptions. Time-limited tolerances are
established for residues of the fungicide, flusilazole, (1-[[bis(4-
fluorophenyl)methylsilyl]methyl]-1H-1,2,4-triazole) in connection with
use of the pesticide under Section 18 emergency exemptions granted by
EPA. The tolerances expire and are revoked on the dates specified in
the following table.
------------------------------------------------------------------------
Expiration/
Commodity Parts per million revocation date
------------------------------------------------------------------------
Soybean, aspirated grain fractions 2.6 12/31/2010
Soybean, seed..................... 0.04 12/31/2010
Soybean, oil...................... 0.10 12/31/2010
------------------------------------------------------------------------
(c) Tolerances with regional registrations. [Reserved]
(d) Indirect or inadvertant residues. [Reserved]
[FR Doc. E7-17110 Filed 8-28-07; 8:45 am]
BILLING CODE 6560-50-S