[Federal Register: August 24, 2005 (Volume 70, Number 163)]
[Rules and Regulations]
[Page 49499-49507]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr24au05-8]
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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 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: Sec-18-Mailbox@epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this Action Apply to Me?
You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
Potentially affected entities may include, but are not limited to:
Crop production (NAICS code 111)
Animal production (NAICS code 112)
Food manufacturing (NAICS code 311)
Pesticide manufacturing (NAICS code 32532)
This listing is not intended to be exhaustive, but rather provides
a guide for readers regarding entities likely to be affected by this
action. Other types of entities not listed in this unit could also be
affected. The North American Industrial Classification System (NAICS)
codes have been provided to assist you and others in determining
whether this action might apply to certain entities. If you have any
questions regarding the applicability of this action to a particular
entity, consult the person listed under FOR FURTHER INFORMATION
CONTACT.
B. How Can I Access Electronic Copies of this Document 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-\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 (MOEcancer = 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
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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: residuemethods@epa.gov.
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: opp-docket@epa.gov.
[[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