[Federal Register Volume 70, Number 163 (Wednesday, August 24, 2005)]
[Rules and Regulations]
[Pages 49499-49507]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-16805]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-2005-0225; FRL-7731-2]


Myclobutanil; Pesticide Tolerances for Emergency Exemptions

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes a time-limited tolerance for 
residues of myclobutanil in or on soybeans. 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 soybeans. This regulation establishes a maximum 
permissible level for residues of myclobutanil in this food commodity. 
The tolerance will expire and is revoked on December 31, 2009.

DATES: This regulation is effective August 24, 2005. Objections and 
requests for hearings must be received on or before October 24, 2005.

ADDRESSES:  To submit a written objection or hearing request follow the 
detailed instructions as provided in Unit VII. of the SUPPLEMENTARY 
INFORMATION. EPA has established a docket for this action under Docket 
identification (ID) number OPP-2005-0225. All documents in the docket 
are listed in the EDOCKET index at http://www.epa.gov/edocket. Although 
listed in the index, some information is not publicly available, i.e., 
CBI or other information whose disclosure is restricted by statute. 
Certain other material, such as copyrighted material, is not placed on 
the Internet and will be publicly available only in hard copy form. 
Publicly available docket materials are available either electronically 
in EDOCKET or in hard copy at the Public Information and Records 
Integrity Branch (PIRIB), Rm. 119, Crystal Mall <greek-i>2, 1801 S. 
Bell St., Arlington, VA. This docket facility is open from 8:30 a.m. to 
4 p.m., Monday through Friday, excluding legal holidays. The docket 
telephone number is (703) 305-5805.

FOR FURTHER INFORMATION CONTACT:  Andrew Ertman, Registration Division 
(7505C), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone 
number: (703) 308-9367; e-mail address: <a href="/cdn-cgi/l/email-protection#89daeceaa4b8b1a4c4e8e0e5ebe6f1c9ecf9e8a7eee6ff"><span class="__cf_email__" data-cfemail="623107014f535a4f2f030b0e000d1a220712034c050d14">[email protected]</span></a>.

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:
    <bullet> Crop production (NAICS code 111)
    <bullet> Animal production (NAICS code 112)
    <bullet> Food manufacturing (NAICS code 311)
    <bullet> Pesticide manufacturing (NAICS code 32532)
    This listing is not intended to be exhaustive, but rather provides 
a guide for readers regarding entities likely to be affected by this 
action. Other types of entities not listed in this unit could also be 
affected. The North American Industrial Classification System (NAICS) 
codes have been provided to assist you and others in determining 
whether this action might apply to certain entities. If you have any 
questions regarding the applicability of this action to a particular 
entity, consult the person listed under FOR FURTHER INFORMATION 
CONTACT.

 B. How Can I Access Electronic Copies of this Document and Other 
Related Information?

    In addition to using EDOCKET (http://www.epa.gov/edocket/), you may 
access this Federal Register document electronically through the EPA 
Internet under the ``Federal Register'' listings at http://www.epa.gov/fedrgstr/. A frequently updated electronic version of 40 CFR part 180 
is available on E-CFR Beta Site Two at http://www.gpoaccess.gov/ecfr/.

II. Background and Statutory Findings

    EPA, on its own initiative, in accordance with sections 408(e) and 
408 (l)(6) of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 
U.S.C. 346a, is establishing a tolerance for combined residues of the 
fungicide myclobutanil alpha-butyl-alpha-(4-chlorophenyl)-1H-1,2,4-
triazole-1-propanenitrile and its alcohol metabolite (alpha-(3-
hydroxybutyl)-alpha-(4-chlorophenyl)-1H-1,2,4-triazole-1-propanenitrile 
(free and bound), in or on soybean at 0.05 parts per million (ppm). EPA 
will publish a document in the Federal Register to remove the revoked 
tolerance from the Code of Federal Regulations.
    Section 408(l)(6) of the FFDCA requires 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 (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....''
    Section 18 of the FIFRA authorizes EPA to exempt any Federal or 
State agency from any provision of FIFRA, if EPA determines that 
``emergency conditions exist which require such exemption.'' This 
provision was not amended by the Food Quality Protection Act of 1996 
(FQPA). EPA has established regulations governing such emergency 
exemptions in 40 CFR part 166.

III. Emergency Exemption for Myclobutanil on Soybeans and FFDCA 
Tolerances

    The States of Minnesota and South Dakota, as lead state agencies in 
what is essentially a ``national'' section 18 request for all soybean 
growing states, have petitioned the Agency requesting an emergency 
exemption for myclobutanil to control soybean rust

[[Page 49500]]

under section 18 of the Federal Insecticide, Fungicide, and Rodenticide 
Act (FIFRA). On November 10, 2004, the U.S. Department of Agriculture's 
Animal and Plant Health Inspection Service (USDA/APHIS) confirmed the 
presence of Phakopsora pachyrhizi, the pathogen that causes soybean 
rust, on soybean leaf samples taken from two plots associated with a 
Louisiana State University research farm. Soybean rust has been 
designated as a biosecurity threat and therefore it is important that 
control measures be available for the disease. EPA has authorized under 
FIFRA section 18 the use of myclobutanil on soybeans for control of 
soybean rust in Minnesota, South Dakota, and all the other states that 
have requested an exemption for this use. After having reviewed the 
submission, 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 myclobutanil in or on 
soybeans. 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 FIFRA section 18. Consistent with the need to 
move quickly on the emergency exemption in order to address an urgent 
non-routine situation and to ensure that the resulting food is safe and 
lawful, EPA is issuing this tolerance without notice and opportunity 
for public comment as provided in section 408(l)(6) of the FFDCA. 
Although this tolerance will expire and is revoked on December 31, 
2009, 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 soybeans 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 indicate that the residues are 
not safe.
    Because this tolerance is being approved under emergency 
conditions, EPA has not made any decisions about whether myclobutanil 
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 myclobutanil by a state for special local 
needs under FIFRA section 24(c). Nor does this tolerance serve as the 
basis for any state other than those which have been granted exemptions 
as part of the soybean rust section 18 to use this pesticide on this 
crop under section 18 of FIFRA without 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 myclobutanil, contact the Agency's Registration Division at the 
address provided under FOR FURTHER INFORMATION CONTACT.

IV. Aggregate Risk Assessment and Determination of Safety

    EPA performs a number of analyses to determine the risks from 
aggregate exposure to pesticide residues. For further discussion of the 
regulatory requirements of section 408 of the FFDCA and a complete 
description of the risk assessment process, see the final rule on 
Bifenthrin Pesticide Tolerances (62 FR 62961, November 26, 1997) (FRL-
5754-7).
    Consistent with section 408(b)(2)(D) of the 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 
myclobutanil and to make a determination on aggregate exposure, 
consistent with section 408(b)(2) of the FFDCA, for a time-limited 
tolerance for residues of myclobutanil in or on soybeans at 0.05 ppm. 
EPA's assessment of the dietary exposures and risks associated with 
establishing the tolerance follows.

A. Toxicological Endpoints

    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 endpoint. However, the 
lowest dose at which adverse effects of concern are identified (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. An UF of 100 
is routinely used, 10X to account for interspecies differences and 10X 
for intraspecies differences.
    For dietary risk assessment (other than cancer) the Agency uses the 
UF to calculate an acute or chronic reference dose (acute RfD or 
chronic RfD) where the RfD is equal to the NOAEL divided by the 
appropriate UF (RfD = NOAEL/UF). Where an additional safety factor is 
retained due to concerns unique to the FQPA, this additional factor is 
applied to the RfD by dividing the RfD by such additional factor. The 
acute or chronic Population Adjusted Dose (aPAD or cPAD) is a 
modification of the RfD to accommodate this type of FQPA SF.
    For non-dietary risk assessments (other than cancer) the UF is used 
to determine the level of concern (LOC). For example, when 100 is the 
appropriate UF (10X to account for interspecies differences and 10X for 
intraspecies differences) the LOC is 100. To estimate risk, a ratio of 
the NOAEL to exposures (margin of exposure (MOE) = NOAEL/exposure) is 
calculated and compared to the LOC.
    The linear default risk methodology (Q*) is the primary method 
currently used by the Agency to quantify carcinogenic risk. The Q* 
approach assumes that any amount of exposure will lead to some degree 
of cancer risk. A Q* is calculated and used to estimate risk which 
represents a probability of occurrence of additional cancer cases 
(e.g., risk is expressed as 1 x 10<SUP>-</SUP>\6\ or one in a million). 
Under certain specific circumstances, MOE calculations will be used for 
the carcinogenic risk assessment. In this non-linear approach, a 
``point of departure'' is identified below which carcinogenic effects 
are not expected. The point of departure is typically a NOAEL based on 
an endpoint related to cancer effects though it may be a different 
value derived from the dose response curve. To estimate risk, a ratio 
of the point of departure to exposure (MOE<INF>cancer</INF> = point of 
departure/exposures) is calculated. A summary of the toxicological 
endpoints for myclobutanil used for human risk assessment is shown in 
the following table:

[[Page 49501]]



     Table 1.--Summary of Toxicological Dose and Endpoints for Myclobutanil for Use in Human Risk Assessment
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                                                                  Hazard and Exposure
          Exposure/Scenario               Dose Used in Risk/       Based Special FQPA    Study and Toxicological
                                            Assessment, UF           Safety Factor*              Effects
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Acute dietary                          NOAEL = 60 milligrams/   FQPA SF = 1X             Developmental toxicity
(Females 13-50)......................   kilogram/day (mg/kg/    aPAD = acute RfD.......   study - Rats
                                        day)                    = 0.6 mg/kg/day........  LOAEL = 200 mg/kg/day
                                       UF =100................                            based on increased
                                       Acute RfD = 0.6 mg/kg/                             resorptions, decreased
                                        day.                                              litter size
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Chronic dietary                        NOAEL= 2.49 mg/kg/day    FQPA SF = 1X             Chronic toxicity/
(All populations)....................  UF = 100...............  cPAD = chronic RfD.....   Oncogenicity study -
                                       Chronic RfD = 0.025 mg/  = 0.025 mg/kg/day......   Rats
                                        kg/day.                                          LOAEL = 10 mg/kg/day
                                                                                          based on decreased
                                                                                          testicular weights and
                                                                                          increased testicular
                                                                                          atrophy
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Short-term (1-30 days)                 NOAEL = 100 mg ai/kg/    Residential MOE = 100    28-day Dermal toxicity
Dermal...............................   day                                                Rats
                                                                                         There were no signs of
                                                                                          toxicity at the high
                                                                                          dose of 100 mg/kg a.i.
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Intermediate-term                      Oral NOAEL = 10 mg ai/   Residential MOE = 100    2-Generation
(1-6 months) Dermal..................   kg/day                                            reproduction toxicity
                                                                                           Rats
                                                                                         LOAEL = 50 mg/kg bw/day
                                                                                          based on atrophy of
                                                                                          the testes and
                                                                                          prostate as well as an
                                                                                          increase in the number
                                                                                          of stillborn pups and
                                                                                          a decrease in pup
                                                                                          weight gain during
                                                                                          lactation
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Long-term                              Oral NOAEL = 2.49 mg/kg/ Residential MOE = 100    Chronic toxicity/
Dermal (> 6 months)..................   day                                               Carcinogenicity - Rats
                                                                                         LOAEL = 10 mg/kg/day
                                                                                          based on decreased
                                                                                          testicular weights and
                                                                                          increased testicular
                                                                                          atrophy
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Short-term (1-30 Days)                 Oral NOAEL = 10 mg/kg/   Residential MOE = 100    2-Generation
Inhalation...........................   day                                               reproduction toxicity
                                                                                          study - Rats
                                                                                         LOAEL = 50 mg/kg bw/day
                                                                                          based on atrophy of
                                                                                          the testes and
                                                                                          prostate as well as an
                                                                                          increase in the number
                                                                                          of stillborn pups and
                                                                                          a decrease in pup
                                                                                          weight gain during
                                                                                          lactation
----------------------------------------------------------------
Intermediate-term (1-6 months)         Oral NOAEL = 10 mg/kg/   Residential MOE = 100    2-Generation
Inhalation...........................   day                                               reproduction toxicity
                                                                                          study - Rats
                                                                                         LOAEL = 50 mg/kg bw/day
                                                                                          based on atrophy of
                                                                                          the testes and
                                                                                          prostate as well as an
                                                                                          increase in the number
                                                                                          of stillborn pups and
                                                                                          a decrease in pup
                                                                                          weight gain during
                                                                                          lactation
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Long-term                              Oral NOAEL = 2.49 mg/kg/ Residential MOE = 100    Chronic toxicity/
Inhalation (> 6 months)..............   day                                               Carcinogenicity - Rats
                                                                                         LOAEL = 10 mg/kg/day
                                                                                          based on decreased
                                                                                          testicular weights and
                                                                                          increased testicular
                                                                                          atrophy
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Cancer                                                   Group E- likely not a human carcinogen
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* The reference to the FQPA SF refers to any additional SF retained due to concerns unique to the FQPA.

B. Exposure Assessment

    1. Dietary exposure from food and drinking water. Tolerances are 
established for combined residues of the fungicide myclobutanil alpha-
butyl-alpha-(4-chlorophenyl)-1H-1,2,4-triazole-1-propanenitrile and its 
alcohol metabolite alpha-(3-hydroxybutyl)-alpha-(4-chlorophenyl)-1H-
1,2,4-triazole-1-propanenitrile (free and bound), ranging from 0.02 ppm 
on cotton seed and eggs to 25 ppm on grape raisin waste. Time-limited 
tolerances and tolerances for inadvertent residues have also been 
established.
    In conducting the acute and chronic dietary risk assessments, EPA 
used the Dietary Exposure Evaluation Model (DEEM\TM\) software. Modeled 
estimates of drinking water concentrations were directly entered into 
the exposure model to assess the contribution from drinking water. Risk 
assessments were conducted by EPA to assess dietary exposures from 
myclobutanil in food as follows:
    i. Acute exposure. Acute dietary risk assessments are performed for 
a food-use pesticide if a toxicological study has indicated the 
possibility of an effect of concern occurring as a result of a 1-day or 
single exposure. The DEEM\TM\ analysis evaluated the individual food 
consumption as reported by respondents in the USDA 1994-1996 and 1998 
nationwide Continuing Surveys of Food Intake by Individuals (CSFII) and 
accumulated exposure to the chemical for each commodity. The acute 
analysis is a conservative Tier 1 assessment based on tolerance-level 
residues and the assumption of 100% crop treated (PCT) for established 
and proposed myclobutanil tolerances. DEEM\TM\ default processing 
factors from DEEM\TM\ (Version 7.76) were used for all processed 
commodities that do not have individual tolerances. Aggregate acute 
food and water exposure was determined by including modeled estimates 
of drinking water concentrations in the dietary model. The highest 
estimate for acute water exposure, 333 parts per billion (ppb), was 
used in the analysis.
    ii. Chronic exposure. In conducting this chronic dietary risk 
assessment, the DEEM\TM\ analysis evaluated the individual food 
consumption as reported by respondents in the USDA

[[Page 49502]]

1994-1996 and 1998 nationwide CSFII and accumulated exposure to the 
chemical for each commodity. The chronic analysis is based on partially 
refined Tier 3 assumptions in that it incorporates estimates of average 
PCT for some crops, as well as Pesticide Data Program (PDP) monitoring 
data from apple juice, bananas (not plantains) and milk. The following 
average PCT information was used: Apples, 40%; apricots, 15%; cherries, 
40%; grapes, 45%; nectarines, 20%; peaches, 10%; plums, 15%; and 
cotton, 1%. One hundred PCT was assumed for all other commodities. 
DEEM\TM\ default processing factors from DEEM\TM\ (Version 7.76) were 
used for all processed commodities that do not have individual 
tolerances. Aggregate chronic food and water exposure was determined by 
including modeled estimates of drinking water concentrations in the 
dietary model. The highest estimate for chronic water exposure, 86 ppb, 
was used in the analysis.
    iii. Cancer. The Agency has classified myclobutanil as a ``Group E 
- not likely human carcinogen'' and, therefore, quantification of human 
cancer risk is not required.
    iv. Anticipated residue and PCT information. Section 408(b)(2)(E) 
of the FFDCA authorizes EPA to use available data and information on 
the anticipated residue levels of pesticide residues in food and the 
actual levels of pesticide chemicals that have been measured in food. 
If EPA relies on such information, EPA must pursuant to section 
408(f)(1) require that data be provided 5 years after the tolerance is 
established, modified, or left in effect, demonstrating that the levels 
in food are not above the levels anticipated. Following the initial 
data submission, EPA is authorized to require similar data on a time 
frame it deems appropriate. For the present action, EPA will issue such 
Data Call-Ins for information relating to anticipated residues as are 
required by FFDCA section 408(b)(2)(E) and authorized under FFDCA 
section 408(f)(1). Such Data Call-Ins will be required to be submitted 
no later than 5 years from the date of issuance of this tolerance.
    Section 408(b)(2)(F) of the FFDCA states that the Agency may use 
data on the actual percent of food treated for assessing chronic 
dietary risk only if the Agency can make the following findings: 
Condition 1, that the data used are reliable and provide a valid basis 
to show what percentage of the food derived from such crop is likely to 
contain such pesticide residue; Condition 2, that the exposure estimate 
does not underestimate exposure for any significant subpopulation 
group; and Condition 3, if data are available on pesticide use and food 
consumption in a particular area, the exposure estimate does not 
understate exposure for the population in such area. In addition, the 
Agency must provide for periodic evaluation of any estimates used. To 
provide for the periodic evaluation of the estimate of PCT as required 
by section 408(b)(2)(F) of the FFDCA, EPA may require registrants to 
submit data on PCT.
    The Agency used PCT information as follows: Apples, 40%; apricots, 
15%; cherries, 40%; grapes, 45%; nectarines, 20%; peaches, 10%; plums, 
15%; and cotton, 1%.
    The Agency believes that the three conditions listed above have 
been met. With respect to Condition 1, PCT estimates are derived from 
Federal and private market survey data, which are reliable and have a 
valid basis. EPA uses a weighted average PCT for chronic dietary 
exposure estimates. This weighted average PCT figure is derived by 
averaging State-level data for a period of up to 10 years, and 
weighting for the more robust and recent data. A weighted average of 
the PCT reasonably represents a person's dietary exposure over a 
lifetime, and is unlikely to underestimate exposure to an individual 
because of the fact that pesticide use patterns (both regionally and 
nationally) tend to change continuously over time, such that an 
individual is unlikely to be exposed to more than the average PCT over 
a lifetime. For acute dietary exposure estimates, EPA uses an estimated 
maximum PCT. The exposure estimates resulting from this approach 
reasonably represent the highest levels to which an individual could be 
exposed, and are unlikely to underestimate an individual's acute 
dietary exposure. The Agency is reasonably certain that the percentage 
of the food treated is not likely to be an underestimation. As to 
Conditions 2 and 3, regional consumption information and consumption 
information for significant subpopulations is taken into account 
through EPA's computer-based model for evaluating the exposure of 
significant subpopulations including several regional groups. Use of 
this consumption information in EPA's risk assessment process ensures 
that EPA's exposure estimate does not understate exposure for any 
significant subpopulation group and allows the Agency to be reasonably 
certain that no regional population is exposed to residue levels higher 
than those estimated by the Agency. Other than the data available 
through national food consumption surveys, EPA does not have available 
information on the regional consumption of food to which myclobutanil 
may be applied in a particular area.
    2. Dietary exposure from drinking water. The Agency lacks 
sufficient monitoring exposure data to complete a comprehensive dietary 
exposure analysis and risk assessment for myclobutanil in drinking 
water. Because the Agency does not have comprehensive monitoring data, 
drinking water concentration estimates are made by reliance on 
simulation or modeling taking into account data on the physical 
characteristics of myclobutanil.
    The Agency uses the First Index Reservoir Screening Tool (FIRST) or 
the Pesticide Root Zone/Exposure Analysis Modeling System (PRZM/EXAMS) 
to produce estimates of pesticide concentrations in an index reservoir. 
The screening concentration in ground water (SCI-GROW) model is used to 
predict pesticide concentrations in shallow ground water. For a 
screening-level assessment for surface water EPA will generally use 
FIRST (a Tier 1 model) before using PRZM/EXAMS (a Tier 2 model). The 
FIRST model is a subset of the PRZM/EXAMS model that uses a specific 
high-end runoff scenario for pesticides. While both FIRST and PRZM/
EXAMS incorporate an index reservoir environment, the PRZM/EXAMS model 
includes a percent crop area factor as an adjustment to account for the 
maximum percent crop coverage within a watershed or drainage basin.
    None of these models include consideration of the impact processing 
(mixing, dilution, or treatment) of raw water for distribution as 
drinking water would likely have on the removal of pesticides from the 
source water.
    Based on the FIRST and SCI-GROW models, the estimated environmental 
concentrations (EECs) of myclobutanil for acute exposures are estimated 
to be 333 ppb for surface water and 3.2 ppb for ground water. The EECs 
for chronic exposures are estimated to be 86 ppb for surface water and 
3.2 ppb for ground 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).
    Myclobutanil is present in numerous end-use products, including 
those registered for use on turf, roses, flowers, shrubs and trees. 
Soluble concentrate may be applied with hose-end or trigger bottle 
sprayers. Small scale lawn

[[Page 49503]]

application has the greatest potential for homeowner exposures. Short- 
and intermediate-term exposures are expected for residential handlers. 
The Agency has determined that a 50% dermal absorption factor should be 
applied for intermediate-term assessments. A dermal absorption factor 
is not required for short-term assessments because the NOAEL used is 
based upon a 28-day dermal study.
    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 myclobutanil and any other 
substances and myclobutanil does not appear to produce a toxic 
metabolite produced by other substances. For the purposes of this 
tolerance action, therefore, EPA has not assumed that myclobutanil has 
a common mechanism of toxicity with other substances. For information 
regarding EPA's efforts to determine which chemicals have a common 
mechanism of toxicity and to evaluate the cumulative effects of such 
chemicals, see the policy statements released by EPA's Office of 
Pesticide Programs concerning common mechanism determinations and 
procedures for cumulating effects from substances found to have a 
common mechanism on EPA's website at http://www.epa.gov/pesticides/cumulative/.
    However, the Agency does have concern about potential toxicity to 
1,2,4-triazole and two conjugates, triazolylalanine and triazolyl 
acetic acid, metabolites common to most of the triazole fungicides. To 
support the extension of existing parent triazole-derivative fungicide 
tolerances, EPA conducted an interim human health assessment for 
aggregate exposure to 1,2,4-triazole. The exposure and risk estimates 
presented in this assessment are overestimates of actual likely 
exposures and therefore, should be considered to be highly 
conservative. Based on this assessment EPA concluded that for all 
exposure durations and population subgroups, aggregate exposures to 
1,2,4-triazole are not expected to exceed EPA's LOC. This assessment is 
presented in the April 22, 2005 Federal Register (70 FR 20821) (FRL-
7702-4) notice for another triazole fungicide, tetraconazole. This 
assessment should be considered interim due to the ongoing series of 
studies being conducted by the U.S. Triazole Task Force (USTTF). Those 
studies are designed to provide the Agency with more complete 
toxicological and residue information for free triazole. Upon 
completion of the review of these data, EPA will prepare a more 
sophisticated assessment based on the revised toxicological and 
exposure data bases.

C. Safety Factor for Infants and Children

    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 postnatal 
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.
    As outlined in Table 1 (above), there is a complete toxicity data 
base for myclobutanil and exposure data are complete or are estimated 
based on data that reasonably accounts for potential exposures. In a 
range of laboratory studies to indicate concerns regarding 
developmental toxicity, reproductive toxicity and prenatal and 
postnatal sensitivity, EPA's analysis reconfirmed previous findings, 
that an additional FQPA safety factor is not necessary for 
myclobutanil. Existing default safety factors provide adequate 
protection for public health, including for infants and children.

D. Aggregate Risks and Determination of Safety

    The Agency currently has two ways to estimate total aggregate 
exposure to a pesticide from food, drinking water, and residential 
uses. First, a screening assessment can be used, in which the Agency 
calculates drinking water levels of comparison (DWLOCs) which are used 
as a point of comparison against EECs. The DWLOC values are not 
regulatory standards for drinking water, but are theoretical upper 
limits on a pesticide's concentration in drinking water in light of 
total aggregate exposure to a pesticide in food and residential uses. 
In calculating a DWLOC, the Agency determines how much of the 
acceptable exposure (i.e., the PAD) is available for exposure through 
drinking water (e.g., allowable chronic water exposure (mg/kg/day) = 
cPAD - (average food + residential exposure)). This allowable exposure 
through drinking water is used to calculate a DWLOC.
    A DWLOC will vary depending on the toxic endpoint, drinking water 
consumption, and body weights. Default body weights and consumption 
values as used by the USEPA Office of Water are used to calculate 
DWLOCs: 2 liter (L)/70 kg (adult male), 2L/60 kg (adult female), and 
1L/10 kg (child). Default body weights and drinking water consumption 
values vary on an individual basis. This variation will be taken into 
account in more refined screening-level and quantitative drinking water 
exposure assessments. Different populations will have different DWLOCs. 
Generally, a DWLOC is calculated for each type of risk assessment used: 
Acute, short-term, intermediate-term, chronic, and cancer.
    When EECs for surface water and ground water are less than the 
calculated DWLOCs, EPA concludes with reasonable certainty that 
exposures to the chemical in drinking water (when considered along with 
other sources of exposure for which EPA has reliable data) would not 
result in unacceptable levels of aggregate human health risk at this 
time. Because EPA considers the aggregate risk resulting from multiple 
exposure pathways associated with a pesticide's uses, levels of 
comparison in drinking water may vary as those uses change. If new uses 
are added in the future, EPA will reassess the potential impacts of 
myclobutanil on drinking water as a part of the aggregate risk 
assessment process.
    More recently the Agency has begun using another approach to 
estimate aggregate exposure through food, residential and drinking 
water pathways. In this approach, modeled surface water and ground 
water EECs are directly incorporated into the dietary exposure 
analysis, along with food. This can provide a more realistic estimate 
of exposure because actual body weights and water consumption from the 
CSFII can often be used. The combined food and water exposures are then 
added to estimated exposure from residential sources to calculate 
aggregate risks. Combining screening level estimates of pesticide 
residues in drinking water from drinking water models with what may be 
more realistic values for residues in food is not ideal. Once screening 
level values are combined with more realistic values it is easy to lose 
sight of the fact that aggregate exposure estimate is based on a 
mixture of very conservative and more realistic estimates. Nonetheless, 
this

[[Page 49504]]

concern with mixing screening level and more realistic values is 
outweighed where the Agency is able to incorporate information on 
actual body weights and water consumption into the aggregate exposure 
calculation. This risk assessment for myclobutanil was conducted using 
this approach.
    1. Acute risk. The acute dietary endpoint for females in the 13 to 
50 year age group is based on the NOAEL for a developmental toxicity in 
rabbits which manifested as increases in resorptions, decreases in 
litter size. This endpoint is considered appropriate for females of 
childbearing age (13-50 years old) since the effects could occur due to 
a single in utero exposure. There were no appropriate toxicological 
effects for the general population attributable to a single exposure 
(dose) observed in oral toxicity studies including the maternal effects 
in the developmental toxicity studies in rats and rabbits. Therefore, 
an acute dose and an endpoint were not selected for the general 
population for this risk assessment.
    Using the exposure assumptions discussed in this unit for acute 
exposure, the acute dietary exposure from food and water to 
myclobutanil will occupy 4% of the aPAD for the population subgroup of 
interest, females 13-49 years old.

 Table 2.--Aggregate Risk Assessment for Acute Exposure to Myclobutanil
------------------------------------------------------------------------
                                                               % aPAD/
              Population Subgroup                aPAD (mg/     (Food +
                                                    kg)         Water)
------------------------------------------------------------------------
Females (13-49 years old)                               0.6           4%
------------------------------------------------------------------------

    2. Chronic risk. Using the exposure assumptions described in this 
unit for chronic exposure, EPA has concluded that exposure to 
myclobutanil from food and water will utilize 21% of the cPAD for the 
U.S. population, 41% of the cPAD for all infants < 1 year old, and 45% 
of the cPAD for children 1-2 years old. Based the use pattern, chronic 
residential exposure to residues of myclobutanil is not expected.

Table 3.--Aggregate Risk Assessment for Chronic (Non-Cancer) Exposure to
                              Myclobutanil
------------------------------------------------------------------------
                                                cPAD/(mg/kg/
              Population Subgroup                   day)        % cPAD
------------------------------------------------------------------------
General U.S. population                               0.025          21%
-------------------------------------------------------------
All Infants (< 1 year old)                            0.025          41%
-------------------------------------------------------------
Children (1-2 years old)                              0.025          45%
-------------------------------------------------------------
Children (3-5 years old)                              0.025          38%
-------------------------------------------------------------
Children (6-12 years old)                             0.025          25%
-------------------------------------------------------------
Youth (13-19 years old)                               0.025          16%
-------------------------------------------------------------
Adults (20-49 years old)                              0.025          18%
-------------------------------------------------------------
Adults (50+ years old)                                0.025          19%
-------------------------------------------------------------
Females (13-49 years old)                             0.025          18%
------------------------------------------------------------------------

    3. Short-term risk. Short-term aggregate exposure takes into 
account residential exposure plus chronic exposure to food and water 
(considered to be a background exposure level).
    Myclobutanil is currently registered for uses that could result in 
short-term residential exposure and the Agency has determined that it 
is appropriate to aggregate chronic food and water and short-term 
exposures for myclobutanil. For short-term aggregate exposure risk 
assessment, even though there was no systemic toxicity in a dermal 
study, by combining dermal with oral and inhalation exposures would 
provide the most conservative risk assessment approach. Since all the 
acceptable short-term MOEs are 100 but the NOAELs vary (short-term 
dermal NOAEL is 100 mg/kg/day, all others are 10 mg/kg/day), the 
reciprocal equation approach will be used to calculate aggregate short-
term risk estimates. The aggregate short-term exposure estimates are 
below the Agency's LOC (MOEs < 100).

                                       Table 4.--Aggregate Risk Assessment for Short-Term Exposure to Myclobutanil
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                         Food + Water
                                                                           ---------------------------------------
                                                                                           Average
                     Population Subgroup                        Target MOE                  Food +                  Dermal MOE    Oral MOE    Aggregate
                                                                              NOAEL\1\      Water        MOE\2\                                 MOE\3\
                                                                            (mg/kg/day)    Exposure
                                                                                         (mg/kg/day)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Children (1-2 years old)                                               100           10     0.011230          890          830          140          110
----------------------------------------------------------------------------
U.S. population                                                        100           10     0.005234        1,900        1,400          N/A          800
--------------------------------------------------------------------------------------------------------------------------------------------------------
1 Short-term Oral NOAEL
2 MOE = NOAEL/Exposure
3 Aggregate MOE = [1/ ((1/MOE Food + Water) + (1/MOE Dermal) + (1/MOE Oral))]

    4. Intermediate-term risk. Intermediate-term aggregate exposure 
takes into account non-dietary, non-occupational exposure plus chronic 
exposure to food and water (considered to be a background exposure 
level).
    Myclobutanil is currently registered for use(s) that could result 
in intermediate-term residential exposure and the Agency has determined 
that it is appropriate to aggregate chronic food and water and 
intermediate-term exposures for myclobutanil. For myclobutanil 
intermediate-term aggregate exposure risk assessment, oral, dermal and 
inhalation exposures can be combined because dermal and inhalation 
exposures can be expressed

[[Page 49505]]

as oral equivalent doses. The aggregate intermediate-term exposure 
estimates for myclobutanil do not include inhalation exposure, as there 
is no associated scenario.
    Using the exposure assumptions described in this unit for 
intermediate-term exposures, EPA has concluded that food, water, and 
residential exposures aggregated result in aggregate MOEs of 330 for 
children 1-2 years old and 620 for the general U.S. population. These 
aggregate MOEs do not exceed the Agency's LOC for aggregate exposure to 
food, water and residential uses.

                                   Table 5.--Aggregate Risk Assessment for Intermediate-Term Exposure to Myclobutanil
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                           Average
                                                                                Max         Food +       Dermal        Oral     Residential
                     Population Subgroup                        NOAEL (mg/   allowable      Water       Exposure     Exposure     Exposure    Aggregate
                                                                 kg/day)    exposure\1\    Exposure   (mg/kg/day)  (mg/kg/day)    (mg/kg/       MOE\3\
                                                                            (mg/kg/day)  (mg/kg/day)                              day)\2\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Children (1-2 years old)                                                10          0.1     0.011230        0.018       0.0013       0.0193          330
----------------------------------------------------------------------------
U.S. population                                                         10          0.1     0.005234        0.011          N/A        0.011          620
--------------------------------------------------------------------------------------------------------------------------------------------------------
1 Maximum Exposure (mg/kg/day) = NOAEL/Target MOE of 100.
2 Residential Exposure = The combined dermal and incidental oral ingestion for infants and dermal only for adults.
3 Aggregate MOE = [NOAEL / (Avg Food & Water Exposure + Residential Exposure)]

    5. Aggregate cancer risk for U.S. population. The Agency has 
classified myclobutanil as a ``Group E - not likely human carcinogen'' 
and, therefore, quantification of human cancer risk is not required.
    6. 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 myclobutanil residues.

V. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology (example--gas chromatography) 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: <a href="/cdn-cgi/l/email-protection#3a485f49535e4f5f575f4e52555e497a5f4a5b145d554c"><span class="__cf_email__" data-cfemail="dba9bea8b2bfaebeb6beafb3b4bfa89bbeabbaf5bcb4ad">[email protected]</span></a>.

B. International Residue Limits

    There are no CODEX, Canadian, or Mexican Maximum Residue Limits 
(MRLs) for myclobutanil on soybeans. Therefore, there are no 
international harmonization issues associated with this action.

VI. Conclusion

    Therefore, the tolerance is established for combined residues of 
the fungicide myclobutanil alpha-butyl-alpha-(4-chlorophenyl)-1H-1,2,4-
triazole-1-propanenitrile and its alcohol metabolite (alpha-(3-
hydroxybutyl)-alpha-(4-chlorophenyl)-1H-1,2,4-triazole-1-propanenitrile 
(free and bound), in or on soybeans at 0.05 ppm.

VII. Objections and Hearing Requests

    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. Although the procedures in those 
regulations require some modification to reflect the amendments made to 
the FFDCA by the FQPA, EPA will continue to use those procedures, with 
appropriate adjustments, until the necessary modifications can be made. 
The new section 408(g) of the FFDCA provides essentially the same 
process for persons to ``object'' to a regulation for an exemption from 
the requirement of a tolerance issued by EPA under new section 408(d) 
of the FFDCA, as was provided in the old sections 408 and 409 of the 
FFDCA. However, the period for filing objections is now 60 days, rather 
than 30 days.

A. What Do I Need to Do to File an Objection or Request a Hearing?

    You must file your objection or request a hearing on this 
regulation in accordance with the instructions provided in this unit 
and in 40 CFR part 178. To ensure proper receipt by EPA, you must 
identify docket ID number OPP-2005-0225 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 
24, 2005.
    1. Filing the request. Your objection must specify the specific 
provisions in the regulation that you object to, and the grounds for 
the objections (40 CFR 178.25). If a hearing is requested, the 
objections must include a statement of the factual issue(s) on which a 
hearing is requested, the requestor's contentions on such issues, and a 
summary of any evidence relied upon by the objector (40 CFR 178.27). 
Information submitted in connection with an objection or hearing 
request may be claimed confidential by marking any part or all of that 
information as CBI. Information so marked will not be disclosed except 
in accordance with procedures set forth in 40 CFR part 2. A copy of the 
information that does not contain CBI must be submitted for inclusion 
in the public record. Information not marked confidential may be 
disclosed publicly by EPA without prior notice.
     Mail your written request to: Office of the Hearing Clerk (1900L), 
Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460-0001. You may also deliver your request to the 
Office of the Hearing Clerk in Suite 350, 1099 14th St., NW., 
Washington, DC 20005. The Office of the Hearing Clerk is open from 8 
a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The 
telephone number for the Office of the Hearing Clerk is (202) 564-6255.
    2. Copies for the Docket. In addition to filing an objection or 
hearing request with the Hearing Clerk as described in Unit VII.A., you 
should also send a copy of your request to the PIRIB for its inclusion 
in the official record that is described in ADDRESSES. Mail your 
copies, identified by the docket ID number OPP-2005-0225, to: Public 
Information and Records Integrity Branch, Information Resources and 
Services Division (7502C), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001. In person or by courier, bring a copy to the location of the 
PIRIB described in ADDRESSES. You may also send an electronic copy of 
your request via e-mail to: <a href="/cdn-cgi/l/email-protection#9bf4ebebb6fff4f8f0feefdbfeebfab5fcf4ed"><span class="__cf_email__" data-cfemail="2f405f5f024b404c444a5b6f4a5f4e01484059">[email protected]</span></a>.

[[Page 49506]]

 Please use an ASCII file format and avoid the use of special 
characters and any form of encryption. Copies of electronic objections 
and hearing requests will also be accepted on disks in WordPerfect 6.1/
8.0 or ASCII file format. Do not include any CBI in your electronic 
copy. You may also submit an electronic copy of your request at many 
Federal Depository Libraries.

B. When Will the Agency Grant a Request for a Hearing?

    A request for a hearing will be granted if the Administrator 
determines that the material submitted shows the following: There is a 
genuine and substantial issue of fact; there is a reasonable 
possibility that available evidence identified by the requestor would, 
if established resolve one or more of such issues in favor of the 
requestor, taking into account uncontested claims or facts to the 
contrary; and resolution of the factual issue(s) in the manner sought 
by the requestor would be adequate to justify the action requested (40 
CFR 178.32).

VIII. Statutory and Executive Order Reviews

    This final rule establishes a time-limited tolerance under section 
408 of the FFDCA. 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 due to its lack of significance, 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). 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., or impose any enforceable duty or 
contain any unfunded mandate as described under Title II of the 
Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law 104-4). 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); 
or OMB review or any Agency action under Executive Order 13045, 
entitled Protection of Children from Environmental Health Risks and 
Safety Risks (62 FR 19885, April 23, 1997). 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). Since 
tolerances and exemptions that are established on the basis of a FIFRA 
section 18 exemption under section 408 of the 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. In addition, the Agency has 
determined that this action will not have a substantial direct effect 
on States, on the relationship between the national government and the 
States, or on the distribution of power and responsibilities among the 
various levels of government, as specified in Executive Order 13132, 
entitled Federalism (64 FR 43255, August 10, 1999). Executive Order 
13132 requires EPA to develop an accountable process to ensure 
``meaningful and timely input by State and local officials in the 
development of regulatory policies that have federalism implications.'' 
``Policies that have federalism implications'' is defined in the 
Executive Order to include regulations that have ``substantial direct 
effects on the States, on the relationship between the national 
government and the States, or on the distribution of power and 
responsibilities among the various levels of government.'' This final 
rule directly regulates growers, food processors, food handlers, and 
food retailers, not States. This action does not alter the 
relationships or distribution of power and responsibilities established 
by Congress in the preemption provisions of section 408(n)(4) of the 
FFDCA. For these same reasons, the Agency has determined that this rule 
does not have any ``tribal implications'' as described in Executive 
Order 13175, entitled Consultation and Coordination with Indian Tribal 
Governments (65 FR 67249, November 6, 2000). Executive Order 13175, 
requires EPA to develop an accountable process to ensure ``meaningful 
and timely input by tribal officials in the development of regulatory 
policies that have tribal implications.'' ``Policies that have tribal 
implications'' is defined in the Executive Order to include regulations 
that have ``substantial direct effects on one or more Indian tribes, on 
the relationship between the Federal Government and the Indian tribes, 
or on the distribution of power and responsibilities between the 
Federal Government and Indian tribes.'' This rule will not have 
substantial direct effects on tribal governments, on the relationship 
between the Federal Government and Indian tribes, or on the 
distribution of power and responsibilities between the Federal 
Government and Indian tribes, as specified in Executive Order 13175. 
Thus, Executive Order 13175 does not apply to this rule.

IX. Congressional Review Act

    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the 
Small Business Regulatory Enforcement Fairness Act of 1996, generally 
provides that before a rule may take effect, the agency promulgating 
the rule must submit a rule report, which includes a copy of the rule, 
to each House of the Congress and to the Comptroller General of the 
United States. EPA will submit a report containing this rule and other 
required information to the U.S. Senate, the U.S. House of 
Representatives, and the Comptroller General of the United States prior 
to publication of this final rule in the Federal Register. This final 
rule is not a ``major rule'' as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

    Environmental protection, Administrative practice and procedure, 
Agricultural commodities, Pesticides and pests, Reporting and 
recordkeeping requirements.


    Dated: August 12, 2005.

Lois Rossi,
Director, Registration Division, 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 180.443 is amended by alphabetically adding a commodity to 
the table in paragraph (b) to read as follows:


Sec.  180.443  Myclobutanil; tolerances for residues.

* * * * *
    (b) * * *

[[Page 49507]]



------------------------------------------------------------------------
                                                          Expiration/
             Commodity              Parts per million   Revocation Date
------------------------------------------------------------------------
                                * * * * *
Soybean...........................               0.05           12/31/09
------------------------------------------------------------------------

* * * * *

[FR Doc. 05-16805 Filed 8-23-05; 8:45 am]
BILLING CODE 6560-50-S


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