[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
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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
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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
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[[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