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/ Wednesday, November 19, 2008
[Federal Register: November 19, 2008 (Volume 73, Number 224)]
[Rules and Regulations]
[Page 69554-69559]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr19no08-7]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2007-0226; FRL-8389-1]
Ipconazole; Pesticide Tolerances
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation establishes tolerances for residues of
ipconazole from seed treatment in or on cotton, peanut, soybean, dry
shelled pea and bean (Subgroup 6C), cereal grains (Group 15) except
rice, and forage, fodder, and straw of cereal grains (Group 16) except
rice. Chemtura Corporation requested these tolerances under the Federal
Food, Drug, and Cosmetic Act (FFDCA).
DATES: This regulation is effective November 19, 2008. Objections and
requests for hearings must be received on or before January 20, 2009,
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-2007-0226. All documents in the
docket are listed in the docket index available at http://
www.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 in the electronic
docket at http://www.regulations.gov, or, if only available in hard
copy, at the OPP Regulatory 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: Tawanda Maignan, Registration Division
(7505P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone
number: (703) 308-8050; e-mail address: maignan.tawanda@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 those
engaged in the following activities:
Crop production (NAICS code 111).
Animal production (NAICS code 112).
Food manufacturing (NAICS code 311).
[[Page 69555]]
Pesticide manufacturing (NAICS code 32532).
This listing is not intended to be exhaustive, but rather to
provide 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 electronically available documents at
http://www.regulations.gov, you may access this Federal Register
document electronically through the EPA Internet under the ``Federal
Register'' listings at http://www.epa.gov/fedrgstr. You may also access
a frequently updated electronic version of EPA's tolerance regulations
at 40 CFR part 180 through the Government Printing Office's e-CFR site
at http://www.gpoaccess.gov/ecfr.
C. Can I File an Objection or Hearing Request?
Under section 408(g) of FFDCA, 21 U.S.C. 346a, any person may file
an objection to any aspect of this regulation and may also request a
hearing on those objections. 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-2007-0226 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 as required by 40 CFR part 178
on or before January 20, 2009.
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 this copy, identified by docket ID number
EPA-HQ-OPP-2007-0226, 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 Facility'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. Petition for Tolerance
In the Federal Register of May 9, 2007 (72 FR 26374) (FRL-8121-5),
EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21 U.S.C.
346a(d)(3), announcing the filing of a pesticide petition (PP 7F7180)
by Chemtura Corporation, 199 Benson Rd., Middlebury, CT 06749. The
petition requested that 40 CFR part 180 be amended by establishing
permanent tolerances for residues of the fungicide ipconazole, (2-[(4-
chlorophenyl)methyl]-5-(1-methylethyl)-1-(1H-1,2,4-triazole-1-ylmethyl)
cyclopentanol) from treatment of seed prior to planting, in or on food
commodities cereal grains (except rice), group 15; forage, fodder and
straw of cereal grains (except rice), group 16; cotton; peanut;
soybean; dry pea and bean (shelled) (Subgroup 6C) at 0.01 parts per
million (ppm). That notice referenced a summary of the petition
prepared by Chemtura Corporation, the registrant, which is available to
the public in the docket, http://www.regulations.gov. There were no
comments received in response to the notice of filing.
III. Aggregate Risk Assessment and Determination of Safety
Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a
tolerance (the legal limit for a pesticide chemical residue in or on a
food) only if EPA determines that the tolerance is ``safe.'' Section
408(b)(2)(A)(ii) of 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 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....''
Consistent with section 408(b)(2)(D) of FFDCA, and the factors
specified in section 408(b)(2)(D) of FFDCA, EPA has reviewed the
available scientific data and other relevant information in support of
this action. EPA has sufficient data to assess the hazards of and to
make a determination on aggregate exposure for the petitioned-for
tolerances for residues of ipconazole. EPA's assessment of exposures
and risks associated with establishing tolerances 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. Ipconazole has low acute toxicity via the oral, dermal, and
inhalation routes of exposure. It causes low to mild irritation to the
eyes and skin; it is not a dermal sensitizer. Ipconazole may cause
local, portal-of-entry irritation via all routes following repeated
exposure. Systemic effects that were noted in dogs, mice, rabbits and/
or rats following exposure to ipconazole were generally limited to
decreased body weight, body weight gain, and food consumption; and
liver and kidney effects. Developmental effects were observed only at
the maternally-toxic dose. Ipconazole is classified as not likely to be
a human carcinogen and there is no concern for mutagenicity. Specific
information on the studies received and the nature of the adverse
effects caused by ipconazole 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 at http://www.regulations.gov in
document Ipconazole. Human Health Risk Assessment for the Requested
Seed Treatment Uses on Cotton, Peanut, Soybean, Dry Shelled Pea and
Bean (Subgroup 6C), Cereal Grains (Groups 15 and 16) Except Rice, page
number 16 in docket ID number EPA-HQ-OPP-2007-0226.
B. Toxicological Endpoints
For hazards that have a threshold below which there is no
appreciable risk, a toxicological point of departure
[[Page 69556]]
(POD) is identified as the basis for derivation of reference values for
risk assessment. The POD may be defined as the highest dose at which no
adverse effects are observed (the NOAEL) in the toxicology study
identified as appropriate for use in risk assessment. However, if a
NOAEL cannot be determined, the lowest dose at which adverse effects of
concern are identified (the LOAEL) or a Benchmark Dose (BMD) approach
is sometimes used for risk assessment. Uncertainty/safety factors (UFs)
are used in conjunction with the POD to take into account 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. Safety is assessed for acute and chronic
dietary risks by comparing aggregate food and water exposure to the
pesticide to the acute population adjusted dose (aPAD) and chronic
population adjusted dose (cPAD). The aPAD and cPAD are calculated by
dividing the POD by all applicable UFs. Aggregate short-, intermediate-
, and chronic-term risks are evaluated by comparing food, water, and
residential exposure to the POD to ensure that the margin of exposure
(MOE) called for by the product of all applicable UFs is not exceeded.
This latter value is referred to as the Level of Concern (LOC).
For non-threshold risks, the Agency assumes that any amount of
exposure will lead to some degree of risk. Thus, the Agency estimates
risk in terms of the probability of an occurrence of the adverse effect
greater than that expected in a lifetime. For more information on the
general principles EPA uses in risk characterization and a complete
description of the risk assessment process, see http://www.epa.gov/
pesticides/factsheets/riskassess.htm.
A summary of the toxicological endpoints for ipconazole used for
human risk assessment is shown in Table 1 of this unit.
Table 1.--Summary of Toxicological Doses and Endpoints for Ipconazole for Use in Human Risk Assessment
----------------------------------------------------------------------------------------------------------------
Point of Departure and
Exposure/Scenario Uncertainty/Safety RfD, PAD, LOC for Risk Study and Toxicological
Factors Assessment Effects
----------------------------------------------------------------------------------------------------------------
Acute dietary (General Population No appropriate endpoint attributable to a single dose of ipconazole was
Including Infants and Children) identified for this population.
--------------------------------------
Acute dietary (Females 13-50 years of NOAEL = 10 mg/kg/day Acute RfD = 0.1 mg/kg/ Developmental Toxicity
age) UFA = 10x.............. day Studies in Rats and
UFH = 10x.............. aPAD = 0.1 mg/kg/day... Rabbits
FQPA SF = 1x........... LOAELrats = 30 mg/kg/
day, based on
increased visceral and
skeletal variations
LOAELrabbits = 50 mg/kg/
day, based on
increased incidence of
skeletal variations
and malformations
--------------------------------------
Chronic dietary (All populations) NOAEL = 1.5 mg/kg/day Chronic RfD = 0.015 mg/ Chronic Toxicity Study
UFA = 10x.............. kg/day in Dogs
UFH = 10x.............. cPAD = 0.015 mg/kg/day. LOAEL = 5 mg/kg/day,
FQPA SF = 1x........... based on skin
reddening (both sexes)
and decreased body
weight gain in females
--------------------------------------
Dermal Short-Term (1 to 30 days) And NOAEL = 150 mg/kg/day LOC for MOE = 100 28-Day Dermal Toxicity
Intermediate-Term (1 to 6 months) UFA = 10x.............. Study in Rats
UFH = 10x.............. LOAEL = 1,000 mg/kg/
day, based on
decreased body weight,
body weight gain, and
food consumption, as
well as, increased
incidences of dermal
irritation
--------------------------------------
Inhalation Short-Term (1 to 30 days) NOAEL = 26.1 mg/kg/day LOC for MOE = 100 28-Day Inhalation
And Intermediate-Term (1 to 6 UFA = 10x.............. Toxicity Study in Rats
months) UFH = 10x.............. LOAEL = 78.3 mg/kg/day,
based on decreased
body weight, body
weight gain, and food
consumption in males;
clinical findings,
such as alopecia, in
males and/or females;
meta/hyperplasia and
inflammatory cells in
the respiration tract
in males and/or
females; and increased
leukocytes in females
--------------------------------------
Cancer (Oral, dermal, inhalation) Classification: Not likely to be a human carcinogen, based on two
adequate rodent carcinogenicity studies.
----------------------------------------------------------------------------------------------------------------
UFA = extrapolation from animal to human (interspecies). UFH = potential variation in sensitivity among members
of the human population (intraspecies). UFL = use of a LOAEL to extrapolate a NOAEL. UFS = use of a short-term
study for long-term risk assessment. UFDB = to account for the absence of data or other data deficiency. FQPA
SF = FQPA Safety Factor. PAD = population adjusted dose (a = acute, c = chronic). RfD = reference dose. MOE =
margin of exposure. LOC = level of concern. N/A = Not Applicable.
C. Exposure Assessment
1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to ipconazole, EPA considered exposure under the petitioned-
for tolerances. EPA assessed dietary exposures from ipconazole in food
as follows:
i. Acute and chronic exposure. In conducting the acute and chronic
dietary exposure assessments EPA used the food consumption data from
the USDA 1994-1996 and 1998 CSFII. As to residue levels in food, EPA
acute and chronic assessments used tolerance-level residues, assumed
100% crop treated, and incorporated model-derived, conservative
estimates of ipconazole residues in drinking water.
ii. Cancer. Ipconazole has been classified as not likely to be
carcinogenic based on carcinogenicity
[[Page 69557]]
studies in the rat and mouse which showed no evidence of an increase in
the incidence of tumors. Therefore a cancer dietary exposure assessment
is not needed to assess cancer risk.
iii. Anticipated residue and/or percent crop treated (PCT)
information. EPA did not use anticipated residue and/or PCT information
in the dietary assessment for ipconazole. Tolerance level residues and/
or 100 PCT were assumed for all food commodities.
2. Dietary exposure from drinking water. The Agency used screening
level water exposure models in the dietary exposure analysis and risk
assessment for ipconazole in drinking water. These simulation models
take into account data on the physical, chemical, and fate/transport
characteristics of ipconazole. 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.
Ipconazole is persistent and immobile in terrestrial and aquatic
environments. Data are not available to estimate the leaching potential
of ipconazole from treated seeds. Because ipconazole is persistent in
soil, there is a potential for it to accumulate in soil on sites with
use over consecutive years. Steady-state ipconazole concentrations in
soil are predicted to plateau at 0.7 lbs a.i./A after 20 years of
consecutive use.
Based on the First Index Reservoir Screening Tool (FIRST) and
Screening Concentration in Ground Water (SCI-GROW) models, the
estimated drinking water concentrations (EDWCs) of ipconazole from
newly proposed seed uses on cotton, peanuts, soybean, cereal grains
(except rice), and pea and bean (dry shelled) would not exceed the
drinking water concentrations previously assessed for the seed
treatment for potatoes. Potatoes are expected to yield the highest
concentration of ipconazole due to the high seeding rates. Therefore,
the Agency incorporated the drinking water concentrations from potatoes
directly into the dietary analysis.
For acute dietary risk assessment, the surface water concentration
value of 4.589 part per billion (ppb) was used to assess the
contribution to drinking water.
For chronic (non-cancer) dietary risk assessment, the surface water
concentration value of 1.840 ppb was used to assess the contribution of
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).
Ipconazole is not registered for any specific use patterns that
would result in residential exposure.
4. Cumulative effects from substances with a common mechanism of
toxicity. Section 408(b)(2)(D)(v) of 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.''
Ipconazole is a member of the triazole-containing class of
pesticides, often 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. 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.
Triazole-derived pesticides 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, including ipconazole,
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
as of September 1, 2005. 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, 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 September 1, 2005 risk assessment can be
found in the propiconazole reregistration docket at http://
www.regulations.gov (Docket ID EPA-HQ-OPP-2005-0497). An addendum to
the risk assessment, Dietary Exposure Assessments for the Common
Triazole Metabolites 1,2,4-triazole, Triazolylalanine, Triazolylacetic
Acid and Triazolylypyruvic Acid; Updated to Include New Uses of
Fenbuconazole, Ipconazole, Metconazole, Tebuconazole, and Uniconazole;
and a Change in Plant-back Restriction for Tetraconazole can be found
at http://www.regulations.gov in docket ID EPA-HQ-OPP-2007-0226.
D. Safety Factor for Infants and Children
1. In general. Section 408(b)(2)(c) of FFDCA provides that EPA
shall apply an additional tenfold (10X) margin of safety for infants
and children in the case of threshold effects to account for prenatal
and postnatal toxicity and the completeness of the database on toxicity
and exposure unless EPA determines based on reliable data that a
different margin of safety will be safe for infants and children. This
additional margin of safety is commonly referred to as the FQPA safety
factor (SF). In applying this provision, EPA either retains the default
value of 10X, or uses a different additional safety factor when
reliable data available to EPA support the choice of a different
factor.
2. Prenatal and postnatal sensitivity. Offspring effects only
occurred in the presence of maternal toxicity; offspring effects were
not considered more severe than the parental effects. Therefore, HED
concluded that there is no quantitative or qualitative evidence of
increased susceptibility to rat or rabbit fetuses exposed in utero and/
or post-natally to ipconazole.
3. Conclusion. EPA has determined that reliable data show the
safety of infants and children would be adequately protected if the
FQPA SF were reduced to 1X. That decision is based on the following
findings:
[[Page 69558]]
i. The toxicity database for ipconazole is adequate for the
purposes of this risk assessment.
ii. There is no indication that ipconazole is a neurotoxic chemical
and there is no need for a developmental neurotoxicity study or
additional UFs to account for neurotoxicity.
iii. There is no evidence that ipconazole results in increased
susceptibility in in utero rats or rabbits in the prenatal
developmental studies or in young rats in the 2-generation reproduction
study.
iv. There are no residual uncertainties identified in the exposure
databases. EPA made conservative (protective) assumptions in the ground
and surface water modeling used to assess exposure to ipconazole in
drinking water. EPA used similarly conservative assumptions to assess
post-application exposure of children as well as incidental oral
exposure of toddlers. These assessments will not underestimate the
exposure and risks posed by ipconazole.
E. Aggregate Risks and Determination of Safety
EPA determines whether acute and chronic pesticide exposures are
safe by comparing aggregate exposure estimates to the aPAD and cPAD.
The aPAD and cPAD represent the highest safe exposures, taking into
account all appropriate SFs. EPA calculates the aPAD and cPAD by
dividing the POD by all applicable UFs. For linear cancer risks, EPA
calculates the probability of additional cancer cases given the
estimated aggregate exposure. Short-, intermediate-, and chronic-term
risks are evaluated by comparing the estimated aggregate food, water,
and residential exposure to the POD to ensure that the MOE called for
by the product of all applicable UFs is not exceeded.
1. Acute risk. An acute aggregate risk assessment takes into
account exposure estimates from acute dietary consumption of food and
drinking water. Using the exposure assumptions described in this unit
for acute exposure, EPA has concluded that acute exposure to ipconazole
from food and water will utilize <1% of the aPAD for the population
group females 13-49 years old, the only population subgroup appropriate
for inclusion in an acute dietary exposure assessment.
2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that chronic exposure to
ipconazole from food and water will utilize 1.2% of the cPAD for all
infants (the population group receiving the greatest exposure).
3. Short-term and intermediate-term risk. Short-term and
intermediate-term aggregate exposure takes into account short-term and
intermediate-term residential exposure plus chronic exposure to food
and water (considered to be a background exposure level).
Ipconazole is not registered for any use patterns that would result
in short-term and intermediate-term residential exposure. Therefore,
the short-term and intermediate-term aggregate risk, individually is
the sum of the risk from exposure to ipconazole through food and water,
which has already been addressed, and will not be greater than the
chronic aggregate risk.
4. Aggregate cancer risk for U.S. population. Ipconazole has been
classified as not likely to be carcinogenic, and is not expected to
pose a cancer risk 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 or to infants and children from aggregate
exposure to ipconazole residues.
IV. Other Considerations
A. Analytical Enforcement Methodology
Adequate liquid chromatography/mass spectrometry/mass spectrometry
(LC/MS/MS) enforcement methodology (AC/3020) is available to enforce
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
No Codex MRLs have been established for ipconazole. No Canadian or
Mexican MRLs have been established.
C. Revisions to Petitioned-For Tolerances
The proposed tolerance for crop subgroup 6C has been modified to
reflect the correct commodity definition: ``Pea and bean, dried
shelled, except soybean, subgroup 6C.''
V. Conclusion
Therefore, tolerances are established for residues of ipconazole,
(2-[(4-chlorophenyl)methyl]-5-(1-methylethyl)-1-(1H-1,2,4-triazole-1-
ylmethyl) cyclopentanol) from treatment of seed prior to planting, in
or on cotton, peanut, soybean, pea and bean, dried shelled, except
soybean (Subgroup 6C), cereal grains (Group 15) except rice, and
forage, fodder, and straw of cereal grains (Group 16) except rice at
0.01 ppm.
VI. Statutory and Executive Order Reviews
This final rule establishes tolerances under section 408(d) of
FFDCA in response to a petition submitted to the Agency. The Office of
Management and Budget (OMB) has exempted these types of actions from
review under Executive Order 12866, entitled Regulatory Planning and
Review (58 FR 51735, October 4, 1993). Because this final rule has been
exempted from review under Executive Order 12866, this final rule is
not subject to Executive Order 13211, entitled 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 9, 2000) do not apply to this final rule. In addition,
this final rule does not impose any enforceable
[[Page 69559]]
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: November 5, 2008.
Debra Edwards,
Director, Office of Pesticide Programs.
0
Therefore, 40 CFR Chapter I is amended as follows:
PART 180--[AMENDED]
0
1. The authority citation for part 180 continues to read as follows:
Authority: 21 U.S.C. 321(q), 346a and 371.
0
2. Section 180.646 is added to subpart C to read as follows:
Sec. 180.646 Ipconazole; tolerances for residues.
(a) General. Tolerances are established for residues of ipconazole,
(2-[(4-chlorophenyl)methyl]-5-(1-methylethyl)-1-(1H-1,2,4-triazole-1-
ylmethyl) cyclopentanol) from seed treatment in or on the following
commodities:
----------------------------------------------------------------------------------------------------------------
Commodity Parts per million
----------------------------------------------------------------------------------------------------------------
Cotton, gin byproducts................................ 0.01
Cotton, undelinted seed............................... 0.01
Grain, cereal, forage, fodder and straw, group 16, 0.01
except rice..........................................
Grain, cereal group 15, except rice................... 0.01
Pea and bean, dried shelled, except soybean, subgroup 0.01
6C...................................................
Peanut................................................ 0.01
Soybean, forage....................................... 0.01
Soybean, seed......................................... 0.01
----------------------------------------------------------------------------------------------------------------
(b) Section 18 emergency exemptions. [Reserved]
(c) Tolerances with regional registrations. [Reserved]
(d) Indirect or inadvertent residues. [Reserved]
[FR Doc. E8-27310 Filed 11-18-08; 8:45 am]
BILLING CODE 6560-50-S
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