

[Federal Register: August 29, 2007 (Volume 72, Number 167)]
[Rules and Regulations]               
[Page 49660-49666]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr29au07-5]                         

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2007-0327; FRL-8135-6]

 
Flutriafol; Time-Limited Pesticide Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes a time-limited tolerance for 
residues of flutriafol per se in or on soybean. This action is in 
response to EPA's granting of an emergency exemption under section 18 
of the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA) 
authorizing use of the pesticide on soybean. This regulation 
establishes a maximum permissible level for residues of flutriafol per 
se in this food commodity. The tolerance will expire and is 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-2007-0327. 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 OPP 

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: Princess Campbell, Registration 
Division (7505P), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001; telephone number: (703) 308-8033; e-mail 
address:campbell.princess@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

[[Page 49661]]

http://www.epa.gov/fedrgstr. You may also access a frequently updated 

electronic version of 40 CFR part 180 through the Government Printing 
Office's pilot e-CFR site at 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-2007-0327 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-2007-0327, 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 21 U.S.C. 346a, is establishing a time-limited tolerance 
for residues of the fungicide flutriafol per se in or on soybean at 
0.10 parts per million (ppm). The tolerance will expire and is revoked 
on December 31, 2010.
    Section 408(l)(6) of the FFDCA allows 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 or exemption from the requirement for a tolerance for 
pesticide (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. . . 
.''

III. Emergency Exemption for Flutriafol on Soybeans and FFDCA 
Tolerances

     EPA has authorized under section 18 of FIFRA the use of flutriafol 
on soybeans for control of Australasian soybean rust initially in 
Minnesota and South Dakota and subsequently in multiple states. After 
having reviewed the submissions, EPA concurs that emergency conditions 
exist for these States.
     As part of its assessment of this emergency exemption, EPA 
assessed the potential risks presented by residues of flutriafol per se 
in or on soybean seed. In doing so, EPA considered the safety standard 
in section 408(b)(2) of the FFDCA, and EPA decided that the necessary 
tolerance under section 408(l)(6) of the FFDCA would be consistent with 
the safety standard and with section 18 of FIFRA. 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 this tolerance without notice and 
opportunity for public comment as provided in section 408(l)(6) of the 
FFDCA. Although this tolerance will expire and is 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 tolerance 
remaining in or on soybean 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 a level that was authorized by 
this tolerance at the time of that application. EPA will take action to 
revoke this tolerance earlier if any experience with, scientific data 
on, or other relevant information on this pesticide indicates that the 
residues are not safe.
     Because this tolerance is being approved under emergency 
conditions EPA has not made any decisions about whether flutriafol 
meets EPA's registration requirements for use on soybeans or whether a 
permanent tolerance for this use would be appropriate. Under these 
circumstances, EPA does not believe that this tolerance serves as a 
basis for registration of flutriafol by a State for special local needs 
under section 24(c) of FIFRA. Nor does this tolerance serve as the 
basis for any States 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 
flutriafol, 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

[[Page 49662]]

available scientific data and other relevant information in support of 
this action. EPA has sufficient data to assess the hazards of and to 
make a determination on aggregate exposure, consistent with section 
408(b)(2) of the FFDCA, for a tolerance for residues of flutriafol per 
se on soybean at 0.10 ppm. EPA's assessment of exposures and risks 
associated with establishing the tolerance follows.

A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered its 
validity, completeness, and reliability as well as the relationship of 
the results of the studies to human risk. EPA has also considered 
available information concerning the variability of the sensitivities 
of major identifiable subgroups of consumers, including infants and 
children. Specific information on the studies received and the nature 
of the toxic effects caused by flutriafol 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 in the docket at 
http://www.regulations.gov, docket ID number EPA-HQ-OPP-2007-0327 (see 

memo from Tyler, et al. dated March 30, 2006).

B. Toxicological Endpoints

    For hazards that have a threshold below which there is no 
appreciable risk, the dose at which no adverse effects are observed 
(the NOAEL) from the toxicology study identified as appropriate for use 
in risk assessment is used to estimate the toxicological level of 
concern (LOC). However, the LOAEL is sometimes used for risk assessment 
if no NOAEL was achieved in the toxicology study selected. An 
uncertainty factor (UF) is applied to reflect uncertainties inherent in 
the extrapolation from laboratory animal data to humans and in the 
variations in sensitivity among members of the human population as well 
as other unknowns.
    The linear default risk methodology (Q*) is the primary method 
currently used by the Agency to quantify non-threshold hazards such as 
cancer. The Q* approach assumes that any amount of exposure will lead 
to some degree of cancer risk, and estimates risk in terms of the 
probability of occurrence of additional cancer cases. Under certain 
specific circumstances, margin of exposure (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 flutriafol used for human risk assessment is shown as 
follows:

      Table 1.--Summary of Toxicological Dose and Endpoints for flutriafol for Use in Human Risk Assessment
----------------------------------------------------------------------------------------------------------------
                                                                 FQPA SF* and level of
          Exposure/Scenario               Dose used in risk         concern for risk     Study and toxicological
                                            assessment, UF             assessment                effects
----------------------------------------------------------------------------------------------------------------
Acute dietary (Females 13-50 years of  NOAEL = < 10.0 millgrams/ FQPA SF = 10X            Developmental toxicity
 age)                                   kilogram/day (mg/kg/    acute population           rat
                                        day)                     adjusted dose (aPAD) =  LOAEL = 10.0 mg/kg/day
                                       UF = 1,000X............   acute Reference Dose     based on increased
                                       Acute RfD = 0.01 mg/kg/   (RfD).                   number of unossified
                                        day.                                              odontoids, variations
                                                                                          in occipitals and
                                                                                          calcanea of hindlimbs
                                                                                          and increased scores
                                                                                          of m,anus and pes
----------------------------------------------------------------------------------------------------------------
Acute dietary (General population      NOAEL = Not applicable   FQPA SF = Not            An endpoint of concern
 including infants and children)                                 applicable               attributable to a
                                                                                          single dose for
                                                                                          general population was
                                                                                          not identified
----------------------------------------------------------------------------------------------------------------
Chronic dietary (All populations)      NOAEL = < 10.0 mg/kg/day  FQPA SF = 10X            Developmental toxicity-
                                       UF = 1,000X............  cPAD = chronic RfD.....   rat
                                       Chronic RfD = 0.01 mg/                            LOAEL = 10.0 mg/kg/day
                                        kg/day.                                           based on increased
                                                                                          number of unossified
                                                                                          odontoids, variations
                                                                                          in occipitals and
                                                                                          calcanea of hindlimbs
                                                                                          and increased scores
                                                                                          of m,anus and pes
----------------------------------------------------------------------------------------------------------------
Short-term dermal (1 to 7 days)        Dermal (or oral) study   LOC for MOE = 1,000      Developmental toxicity
 (Residential)                          NOAEL = < 10.0 mg/kg/     (residential)            rat
                                        day                                              LOAEL = 10.0 mg/kg/day
                                       (Dermal absorption rate                            based on increased
                                        = 11.0%).                                         number of unossified
                                                                                          odontoids, variations
                                                                                          in occipitals and
                                                                                          calcanea of hindlimbs
                                                                                          and increased scores
                                                                                          of m,anus and pes
----------------------------------------------------------------------------------------------------------------
Intermediate-term dermal (1 week to    Dermal (or oral) study   LOC for MOE = 1,000      Developmental toxicity
 several months) (Residential)          NOAEL = < 10.0 mg/kg/     (residential)            rat
                                        day                                               LOAEL = 10.0 mg/kg/day
                                       (Dermal absorption rate                            based on increased
                                        = 11.0%.                                          number of unossified
                                                                                          odontoids, variations
                                                                                          in occipitals and
                                                                                          calcanea of hindlimbs
                                                                                          and increased scores
                                                                                          of m,anus and pes
----------------------------------------------------------------------------------------------------------------
Long-term dermal (Several months to    Dermal (or oral) study   LOC for MOE = 1,000      Developmental toxicity
 lifetime) (Residential)                NOAEL = < 10.0 mg/kg/     (residential)            rat
                                        day                                              LOAEL = 10.0 mg/kg/day
                                       (Dermal absorption rate                            based on increased
                                        = 11.0% when                                      number of unossified
                                        appropriate).                                     odontoids, variations
                                                                                          in occipitals and
                                                                                          calcanea of hindlimbs
                                                                                          and increased scores
                                                                                          of m,anus and pes
----------------------------------------------------------------------------------------------------------------
Short-term inhalation (1 to 7 days)    Inhalation (or oral)     LOC for MOE = 1,000      Developmental toxicity
 (Residential)                          study NOAEL = < 10.0 mg/  (residential)            rat
                                        kg/day                                           LOAEL = 10.0 mg/kg/day
                                       (Inhalation absorption                             based on increased
                                        rate = 100%).                                     number of unossified
                                                                                          odontoids, variations
                                                                                          in occipitals and
                                                                                          calcanea of hindlimbs
                                                                                          and increased scores
                                                                                          of m,anus and pes
----------------------------------------------------------------------------------------------------------------

[[Page 49663]]


Intermediate-term inhalation (1 week   Inhalation (or oral)     LOC for MOE = 1,000      Developmental toxicity
 to several months) (Residential)       study NOAEL = < 10.0 mg/  (residential)             rat
                                        kg/day                                           LOAEL = 10.0 mg/kg/day
                                       (Inhalation absorption                             based on increased
                                        rate = 100%).                                     number of unossified
                                                                                          odontoids, variations
                                                                                          in occipitals and
                                                                                          calcanea of hindlimbs
                                                                                          and increased scores
                                                                                          of m,anus and pes
----------------------------------------------------------------------------------------------------------------
Long-term inhalation (several months   Inhalation (or oral)     LOC for MOE = 1,000      Developmental toxicity
 to lifetime) (Residential)             study NOAEL = < 10.0 mg/  (residential)            rat
                                        kg/day (inhalation                               LOAEL = 10.0 mg/kg/day
                                        absorption rate =                                 based on increased
                                        100%)                                             number of unossified
                                                                                          odontoids, variations
                                                                                          in occipitals and
                                                                                          calcanea of hindlimbs
                                                                                          and increased scores
                                                                                          of m,anus and pes
Cancer (oral, dermal, inhalation)      NA. not carcinogenic to  NA                       NA
                                        humans based on the
                                        lack of evidence for
                                        carcinogenicity in
                                        mice and rats
----------------------------------------------------------------------------------------------------------------
* The reference to the FQPA SF refers to any additional safety factor retained. UF = uncertainty factor; FQPA SF
  = Special FQPA safety factor; NOAEL = no observed adverse effect level; LOAEL = lowest observed adverse effect
  level; PAD = population adjusted dose (a = acute, c = chronic); RfD = reference dose; MOE = margin of
  exposure; and LOC = level of concern.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. Flutriafol is a new 
pesticide ingredient for the U.S. Therefore, there are no existing 
tolerances for flutriafol in 40 CFR part 180. Based on the available 
residue data on soybeans, residues of flutriafol are not expected to 
exceed 0.10 ppm on soybeans that have been treated in accordance with 
the emergency exemption use directions. Risk assessments were conducted 
by EPA to assess dietary exposures from flutriafol 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 one day or single exposure. The Dietary Exposure 
Evaluation Model (DEEM\TM\) analysis evaluated the individual food 
consumption as reported by respondents in the United States Department 
of Agriculture (USDA) Nationwide Continuing Surveys of Food Intake by 
Individuals (CSFII) and accumulated exposure to the chemical for each 
commodity. The following assumptions were made for the acute exposure 
assessments: An acute dietary exposure assessment was performed for 
females 13-49 years old using tolerance level residue, and 100 per cent 
treated (PCT) information for all soybean commodities. Dietary Exposure 
and Risk Assessment, DP322530, J. Tyler, 3/30/06.
     This assessment concludes that the acute dietary exposure 
estimates are below the Agency's level of concern (< 100% aPAD) for the 
general U.S. population and all population subgroups.
    ii. Chronic exposure. In conducting this chronic dietary exposure 
and risk assessment the DEEM\TM\ analysis evaluated the individual food 
consumption as reported by respondents in the USDA Nationwide CSFII and 
accumulated exposure to the chemical for each commodity. The following 
assumptions were made for the chronic exposure assessments: A chronic 
dietary exposure assessment was performed for the general U.S. 
population and various population subgroups using tolerance level 
residue, and 100% CT information for all soybean commodities.
     This assessment concludes that the chronic dietary exposure 
estimates are below the Agency's level of concern (< 100% cPAD) for the 
general U.S. population and all population subgroups. The most highly 
exposed population subgroup is all infants (< 1 year old) at 2.7% cPAD
    iii. Cancer. Preliminary analysis of tumor data indicated a 
significant increased trend in combined adenomas and carcinomas in male 
rat liver tumors. However, there were no significant differences noted 
in pair-wise comparison with controls in either male or female liver 
tumors. Thus, based on lack of evidence of carcinogenicity in both rats 
and mice carcinogenicity studies, the chemical was considered as ``not 
likely'' to be carcinogenic to humans.
    2. Dietary exposure from drinking water. This emergency exemption 
use of flutriafol is the first use for this fungicide in the U.S. As 
such, there are no monitoring exposure data for water for this 
ingredient. Thus, in this risk assessment, drinking water concentration 
estimates are made by reliance on simulation or modeling taking into 
account data on the physical characteristics of flutriafol. Further 
information regarding EPA drinking water models used in pesticide 
exposure assessment can be found at http://www.epa.gov/oppefed1/models/water/index.htm
.

    The Pesticide Root Zone Model/Exposure Analysis Modeling System 
(PRZM/EXAMS) and (SCI-GROW) screening models were used to estimate 
surface water and ground water concentrations of flutriafol. Based on 
the PRZM/EXAMS and SCI-GROW models the estimated environmental 
concentrations (EECs) of flutriafol for acute exposures are estimated 
to be 4.0 [mu]g/L for surface water and 2.0 [mu]g/L for ground water. 
The EECs of flutriafol for chronic exposures are estimated to be 2.0 
[mu]g/L for surface water and 1.0[mu]g/L 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 4.0 [mu]g/L was used to 
assess the contribution to drinking water. For chronic dietary risk 
assessment, the water concentration of value 2.0 [mu]g/L 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).

[[Page 49664]]

    Flutriafol is not registered for use on any sites that would result 
in residential exposure.
    4. Cumulative effects from substances with a common mechanism of 
toxicity. Section 408(b)(2)(D)(v) of the FFDCA requires that, when 
considering whether to establish, modify, or revoke a tolerance, the 
Agency consider ``available information'' concerning the cumulative 
effects of a particular pesticide's residues and ``other substances 
that have a common mechanism of toxicity.''
     Unlike other pesticides for which EPA has followed a cumulative 
risk approach based on a common mechanism of toxicity, EPA has not made 
a common mechanism of toxicity finding as to flutriafol and any other 
substances Flutriafol is a member of the triazole-containing class of 
pesticides commonly referred to as the conazoles. Although conazoles 
act similarly in plants (fungi) by inhibiting ergosterol biosynthesis, 
there is not necessarily a relationship between their 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 conazoles, however, 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 conazoles 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 conazoles share common mechanisms of toxicity 
and EPA is not following a cumulative risk approach based on a common 
mechanism of toxicity for the conazoles. 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/
.

    Flutriafol is a triazole-derived pesticide. This class of compounds 
can form the common metabolite 1,2,4-triazole and two triazole 
conjugates (triazole alanine and triazole acetic acid). To support 
existing tolerances and to establish new tolerances for triazole-
derivative pesticides. U.S. 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 a 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, in assessing the risks for this group of chemicals 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 for the conazole 
group is found in the propiconazole reregistration docket at http://www.regulations.gov
, Docket ID Number EPA-HQ-OPP-2005-0497.


D. 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 pre-natal and post-
natal 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. Pre-natal and post-natal sensitivity. There is no evidence of 
increased susceptibility in the developmental study in rabbits or in 
the 2-generation reproduction study in the rat. Although some effects 
were seen in the rat developmental study, in the rat 2-generation 
reproduction toxicity study the effects occurred at the same dose that 
caused maternal toxicity indicating there was no increased 
susceptibility. These effects were considered to be study variations, 
and the Agency also retained the 10X safety factor to account for these 
variations due to the lack of a well defined NOAEL in the critical 
study. Therefore, there is no residual uncertainty for pre-natal and/or 
post-natal susceptibility. (See memo from Tyler, et al. dated March 30, 
2006.
    3. Conclusion. The Agency evaluated the quality of the hazard and 
exposure data and determined that based on the available hazard and 
exposure data, the FQPA SF should be retained.

E. Aggregate Risks and Determination of Safety

     EPA conducted human-health risk assessments for acute and chronic 
dietary exposures (food and drinking water only). Because there are no 
uses of flutriafol that are expected to result in residential 
exposures, this aggregate risk assessment takes into consideration 
dietary food and drinking water exposure only. Therefore, the acute and 
chronic aggregate estimates would be the same as the dietary exposure 
results. All aggregate exposure and risk estimates are below EPA's 
level of concern.
    1. Acute risk. Including the proposed use on soybeans, human-health 
risk assessments have been conducted for the following exposure 
scenarios: Acute and chronic dietary exposures (food and drinking water 
only). All aggregate exposure and risk estimates are below the Agency's 
level of concern. Because there are no uses of flutriafol that are 
expected to result in residential exposures, this aggregate risk 
assessment takes into consideration dietary food and drinking water 
exposure only. The acute (95th percentile) dietary exposure 
estimates are below HED's level of concern < 100% aPAD for females 13-49 
year old (10% aPAD).
    2. Chronic risk. The chronic dietary exposures estimates are below 
HED's level of concern < 100% chronic population adjusted dose (cPAD) 
for the general population and all population subgroups. The most 
highly-exposed population subgroup is all infants (< 1 year old) at 2.7% 
cPAD:
    3. Short-term risk. Short-term aggregate exposure takes into 
account residential exposure plus chronic exposure to food and water 
(considered to be a background exposure level).
    4. Aggregate cancer risk for U.S. population. For this assessment, 
EPA has concluded that flutriafol is, ``not likely to be carcinogenic 
to humans.''
    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 flutriafol residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology (Method RAM 219/04) submitted by 
the registrant, (email from C. Rodia to J. Tyler, 3/23/06) is available 
to enforce

[[Page 49665]]

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 currently tolerances of 0.10 ppm for soybean in Brazil 
and South Africa.

V. Conclusion

    Therefore, the tolerance is established for residues of flutriafol, 
in or on soybean at 0.10 ppm.

VI. Statutory and Executive Order Reviews

    This final rule establishes a tolerance under section 408(d) of 
FFDCA in response to a petition submitted to the Agency. The Office of 
Management and Budget (OMB) has exempted these types of actions from 
review under Executive Order 12866, entitled Regulatory Planning and 
Review (58 FR 51735, October 4, 1993). Because this rule has been 
exempted from review under Executive Order 12866, 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 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 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).

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: August 22, 2007.
Martha Monell,
Acting Director, Office 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 180.629 is added to read as follows:


Sec.  180.629  Flutriafol; tolerance for residues.

    (a) General. [Reserved]
    (b) Section 18 emergency exemptions. Time-limited tolerances 
specifed in the above table are established for residues of the 
fungicide flutriafol per se (2,4'-difluoro-[alpha]-(1H -1,2,4-triazol-
1-yl-methyl)-benzhydryl alcohol) in or on the specified agricultural 
commodities, resulting from use of the pesticide pursuant to section 18 
emergency exemptions. The tolerances expire and are revoked on the date 
specified in the following table.

----------------------------------------------------------------------------------------------------------------
                                                                                          Expiration/revocation
                                                                   Parts per million               date
----------------------------------------------------------------------------------------------------------------
Soybean                                                                            0.10        December 31, 2010
----------------------------------------------------------------------------------------------------------------


[[Page 49666]]

    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. [Reserved]
[FR Doc. E7-17112 Filed 8-28-07; 8:45 am]

BILLING CODE 6560-50-S
