Document ID: EPA-HQ-OPP-2007-0428-0001
Agency: epa
Document Type: Rule
Title: Flusilazole; Pesticide Tolerances for Emergency Exemptions
Posted Date: 2007-08-29T04:00Z

[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]                         

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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.

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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