Ipconazole; Pesticide Tolerances, 69554-69559 [E8-27310]

Agencies

• ENVIRONMENTAL PROTECTION AGENCY

[Federal Register Volume 73, Number 224 (Wednesday, November 19, 2008)]
[Rules and Regulations]
[Pages 69554-69559]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-27310]


=======================================================================
-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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 https://
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 https://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 
https://www.regulations.gov, you may access this Federal Register 
document electronically through the EPA Internet under the ``Federal 
Register'' listings at https://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 https://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: https://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, https://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 https://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 https://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 https://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 https://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 https://
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 https://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