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EPA ID: [EPA-HQ-OPP-2007-0327; FRL-8135-6]
SUBJECT CATEGORY: Flutriafol; Time-Limited Pesticide Tolerance
DOCUMENT 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.
SUMMARY: Flutriafol,
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:
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.
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 eCFR 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 EPAHQOPP20070327 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 EPAHQOPP20070327, by one of the following methods:
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 timelimited 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 nonroutine 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.
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/EPAPEST/1997/November/Day26/p30948.htm .
Consistent with section 408(b)(2)(D) of the FFDCA, EPA has reviewed the
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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.
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 noobserved adverseeffectlevel (NOAEL) and the lowestobservedadverseeffect level (LOAEL) from the toxicity studies can be found in the docket at http://www.regulations.gov, docket ID number EPAHQOPP20070327 (see memo from Tyler, et al. dated March 30, 2006).
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 nonthreshold 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 nonlinear 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 (MOE
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 1350 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
Shortterm 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
Intermediateterm 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
Longterm 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
Shortterm 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]]
Intermediateterm 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
Longterm 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.
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 fooduse 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 1349 years old using tolerance level residue, and 100 per cent
treated (PCT) information for all soybean commodities. Dietary Exposure and Risk Assessment, DP
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 pairwise 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 (SCIGROW) screening models were used to estimate
surface water and ground water concentrations of flutriafol. Based on
the PRZM/EXAMS and SCIGROW 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 nondietary exposure. The term ``residential exposure'' is used in this document to refer to nonoccupational, nondietary exposure (e.g., for lawn and garden pest control, indoor pest control, termiticides, and flea and tick control on pets).
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 triazolecontaining 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 triazolederived pesticide. This class of compounds can form the common metabolite 1,2,4triazole 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 1,2,4triazole, triazole alanine, and triazole acetic acid resulting from the use of all current and pending uses of any triazolederived fungicide. The risk assessment is a highly conservative, screeninglevel evaluation in terms of hazards associated with common metabolites (e.g., use of a maximum combination of uncertainty factors) and potential dietary and nondietary exposures (i.e., high end estimates of both dietary and nondietary 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 EPAHQOPP20050497.
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 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. Prenatal and postnatal sensitivity. There is no evidence of increased susceptibility in the developmental study in rabbits or in the 2generation reproduction study in the rat. Although some effects were seen in the rat developmental study, in the rat 2generation 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 prenatal and/or postnatal 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 humanhealth 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, humanhealth 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 1349 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 highlyexposed population subgroup is all infants (< 1 year old) at 2.7% cPAD:
3. Shortterm risk. Shortterm 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
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
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the tolerance expression. The method may be requested from: Chief,
Analytical Chemistry Branch, Environmental Science Center, 701 Mapes
Rd., Ft. Meade, MD 207555350; telephone number: (410) 3052905; email
address: residuemethods@epa.gov. B. International Residue Limits
There are currently tolerances of 0.10 ppm for soybean in Brazil and South Africa.
Therefore, the tolerance is established for residues of flutriafol, in or on soybean at 0.10 ppm.
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 LowIncome 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 1044).
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 104113, section 12(d) (15 U.S.C. 272 note).
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).
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.
Therefore, 40 CFR chapter I is amended as follows:
PART 180[AMENDED]
1. The authority citation for part 180 continues to read as follows:
Authority: 21 U.S.C. 321(q), 346a and 371.
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. Timelimited tolerances
specifed in the above table are established for residues of the
fungicide flutriafol per se (2,4'difluoro[alpha](1H 1,2,4triazol
1ylmethyl)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. E717112 Filed 82807; 8:45 am]
BILLING CODE 656050S
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) 3088033; email
address:campbell.princess@epa.gov.
14 CFR Part 39 40 CFR Part 52 14 CFR Part 71 33 CFR Part 165 26 CFR Part 1 50 CFR Part 679 40 CFR Part 180 47 CFR Part 73 33 CFR Part 117 50 CFR Part 17 44 CFR Part 67 50 CFR Part 648 14 CFR Part 97 33 CFR Part 100 40 CFR Part 63 26 CFR Part 301 50 CFR Part 622 39 CFR Part 111 50 CFR Part 660 44 CFR Part 65 40 CFR Parts 52 and 81 40 CFR Part 271 47 CFR Part 64 40 CFR Part 300 14 CFR Part 23 14 CFR Part 25 21 CFR Part 522 50 CFR Part 665 47 CFR Part 76 27 CFR Part 9