Myclobutanil; Pesticide Tolerances for Emergency Exemptions

Note: EPA no longer updates this information, but it may be useful as a reference or resource.

[Federal Register: January 3, 2001 (Volume 66, Number 2)]
[Rules and Regulations]
[Page 298-306]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr03ja01-17]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-301085; FRL-6757-9]
RIN 2070-AB78

Myclobutanil; Pesticide Tolerances for Emergency Exemptions

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes time-limited tolerances for
combined residues of myclobutanil in or on sugarbeet roots, tops and
by-products. This action is in response to the declaration of a crisis
emergency exemption under section 18 of the Federal Insecticide,
Fungicide, and Rodenticide Act (FIFRA) authorizing use of the pesticide
on sugarbeets in the state of Idaho. This regulation establishes a
maximum permissible level for residues of myclobutanil in these food
commodities. The tolerances will expire and are revoked on December 31,
2002.

DATES: This regulation is effective January 3, 2001. Objections and
requests for hearings, identified by docket control number OPP-301085,
must be received by EPA on or before March 5, 2001.

ADDRESSES: Written objections and hearing requests may be submitted by
mail, in person, or by courier. Please follow the detailed instructions
for each method as provided in Unit VII. of the SUPPLEMENTARY
INFORMATION. To ensure proper receipt by EPA, your objections and
hearing requests must identify docket control number OPP-301085 in the
subject line on the first page of your response.

FOR FURTHER INFORMATION CONTACT: By mail: Libby Pemberton, Registration
Division (7505C), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460;
telephone number: (703) 308-9364; and e-mail address:
pemberton.libby@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 categories and entities may include, but are not
limited to:

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Examples of
Categories NAICS codes potentially
affected entities
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Industry 111 Crop production
112 Animal production
311 Food manufacturing
32532 Pesticide
manufacturing
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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 the table could also be
affected. The North American Industrial Classification System (NAICS)
codes have been provided to assist you and others in determining
whether or not this action might apply to certain entities. If you have
questions regarding the applicability of this action to a particular
entity, consult the person listed under FOR FURTHER INFORMATION
CONTACT.

B. How Can I Get Additional Information, Including Copies of This
Document and Other Related Documents?

1. Electronically. You may obtain electronic copies of this
document, and certain other related documents that might be available
electronically, from the EPA Internet Home Page at http://www.epa.gov/.
To access this document, on the Home Page select ``Laws and
Regulations,'' ``Regulations and Proposed Rules,'' and then look up the
entry for this document under the ``Federal Register--Environmental
Documents.'' You can also go directly to the Federal Register listings
at http://www.epa.gov/fedrgstr/. To access the OPPTS Harmonized
Guidelines referenced in this document, go directly to the guidelines
at http://www.epa.gov/opptsfrs/home/guidelin.htm.
2. In person. The Agency has established an official record for
this action under docket control number OPP-301085. The official record
consists of the documents specifically referenced in this action, and
other information related to this action, including any information
claimed as Confidential Business Information (CBI). This official
record includes the documents that are physically located in the
docket, as well as the documents that are referenced in those
documents. The public version of the official record does not include
any information claimed as CBI. The public version of the official
record, which includes printed, paper versions of any electronic
comments submitted during an applicable comment period is available for
inspection in the Public Information and Records Integrity Branch
(PIRIB), Rm. 119, Crystal Mall #2, 1921 Jefferson Davis Hwy.,
Arlington, VA, from 8:30 a.m. to 4 p.m., Monday through Friday,
excluding legal holidays. The PIRIB telephone number is (703) 305-5805.

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 tolerances for combined residues of the
fungicide myclobutanil in or on beet, sugar, roots at 0.05 part per
million (ppm); beet, sugar, tops at 1.0 ppm; beet, sugar, dried pulp at
1.0 ppm; beet, sugar, molasses at 1.0 ppm; and beet, sugar, refined
sugar at 0.70 ppm. These tolerances will expire and are revoked on
December 31, 2002. EPA will publish a document in the Federal Register
to remove the revoked tolerances 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 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) 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)
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 Federal Insecticide, Fungicide, and Rodenticide
Act (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 (FQPA). EPA has established regulations
governing such emergency exemptions in 40 CFR part 166.

III. Emergency Exemption for Myclobutanil on Sugarbeets and FFDCA
Tolerances

EPA has authorized under FIFRA section 18 the use of myclobutanil
on sugarbeets for control of powdery mildew in Idaho. After having
reviewed the submission, EPA concurs that emergency conditions exist
for this State.
As part of its assessment of this emergency exemption, EPA assessed
the potential risks presented by residues of myclobutanil in or on
sugar beets and sugar beet byproducts. In doing so, EPA considered the
safety standard in FFDCA section 408(b)(2), and EPA decided that the
necessary tolerance under FFDCA section 408(l)(6) 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 these tolerances without notice and
opportunity for public comment as provided in section 408(l)(6).
Although these tolerances will expire and are revoked on December 31,
2002, under FFDCA section 408(l)(5), residues of the pesticide not in
excess of the amounts specified in the tolerances remaining in or on
sugar beets and the sugar beet byproducts 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 these tolerances at the time of that application. EPA will take
action to revoke these tolerances earlier if any experience with,
scientific data on, or other relevant information on this pesticide
indicate that the residues are not safe.
Because these tolerances are being approved under emergency
conditions, EPA has not made any decisions about whether myclobutanil
meets EPA's registration requirements for use on sugarbeets or whether
permanent tolerances for this use would be

[[Page 300]]

appropriate. Under these circumstances, EPA does not believe that these
tolerances serve as a basis for registration of myclobutanil by a State
for special local needs under FIFRA section 24(c). Nor do these
tolerances serve as the basis for any State other than Idaho to use
this pesticide on this crop under section 18 of FIFRA without following
all provisions of EPA's regulations implementing 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 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), 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), for time-limited tolerances for
combined residues of myclobutanil in or on beet, sugar, roots at 0.05
ppm; beet, sugar, tops at 1.0 ppm; beet, sugar, dried pulp at 1.0 ppm;
beet, sugar, molasses at 1.0 ppm; and beet, sugar, refined sugar at
0.70 ppm.
EPA's assessment of the dietary exposures and risks associated with
establishing the tolerances 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 (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 Safety Factor.
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 1x10-\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 1:

Table 1.--Summary of Toxicological Dose and Endpoints for Myclobutanil for Use in Human Risk Assessment
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Dose Used in Risk FQPA SF\1\ and LOC for Study and Toxicological
Exposure Scenario Assessment, UF Risk Assessment Effects
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Acute Dietary females 13-50 years of NOAEL = 60 mg/kg/day UF FQPA SF = 1 aPAD = Developmental Toxicity
age = 100 Acute RfD = 0.60 acute RfD FQPA SF = rabbit\2\ LOAEL = 200
mg/kg/day 0.60 mg/kg/day mg/kg/day based on
increased resorptions,
decreased litter size
and a decrease in the
viability index.
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Acute Dietary general population none not applicable not applicable
including infants and children
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Chronic Dietary all populations NOAEL= 2.49 mg/kg/day FQPA SF = 1 cPAD = Chronic Toxicity/
UF = 100 Chronic RfD = chronic RfD FQPA SF = Carcinogenicity - rat
0.025 mg/kg/day 0.025 mg/kg/day LOAEL = 9.94 mg/kg/day
based on decreased
testicular weights and
increased testicular
atrophy.
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Short-Term Dermal (1-7 days) dermal study NOAEL= 100 Acceptable MOE = 100 28-day Dermal Toxicity-
(Occupational/Residential) mg/kg/day (Occupational) rat LOAEL = >100 mg/kg/
Acceptable MOE = 100 day based on no signs
(Residential, includes of toxicity at the
the FQPA SF) high dose of 100 mg/kg
a.i.
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[[Page 301]]

Intermediate-Term Dermal (1 week- oral study NOAEL= 10 mg/ Acceptable MOE = 100 2-Generation
several months) (Occupational/ kg/day (dermal (Occupational) Reproduction Toxicity
Residential) absorption rate = 50%) Acceptable MOE = 100 rat LOAEL = 50 mg/kg/
(Residential, includes day based on atrophy
the FQPA SF) 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 Dermal (several months - oral study NOAEL= 2.49 Acceptable MOE = 100 Chronic Toxicity/
lifetime) (Occupational/Residential) mg/kg/day (dermal (Occupational) Carcinogenicity - rat
absorption rate = 50%) Acceptable MOE = 100 LOAEL = 9.94 mg/kg/day
(Residential, includes based on decreased
the FQPA SF) testicular weights and
increased testicular
atrophy.
----------------------------------------------------------------------------------------------------------------
Short-Term Inhalation (1-7 days) oral study NOAEL= 10 mg/ Acceptable MOE = 100 2-Generation
(Occupational/Residential) kg/day (inhalation (Occupational) Reproduction Toxicity
absorption rate = Acceptable MOE = 100 rat LOAEL = 50 mg/kg/
100%) (Residential, includes day based on atrophy
the FQPA SF) 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 Inhalation (1 week - oral study NOAEL= 10 mg/ Acceptable MOE = 100 2-Generation
several months) (Occupational/ kg/day (inhalation (Occupational) Reproduction Toxicity
Residential) absorption rate = Acceptable MOE = 100 rat LOAEL = 50 mg/kg/
100%) (Residential, includes day based on atrophy
the FQPA SF) 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.
----------------------------------------------------------------------------------------------------------------
Long-Term Inhalation (several months - oral study NOAEL= 2.49 Acceptable MOE = 100 Chronic Toxicity/
lifetime) (Occupational/ mg/kg/day (inhalation (Occupational) Carcinogenicity - rat
Residential) absorption rate = Acceptable MOE = 100 LOAEL = 9.94 mg/kg/day
100%) (Residential, includes based on decreased
the FQPA SF) testicular weights and
increased testicular
atrophy.
----------------------------------------------------------------------------------------------------------------
Cancer (oral, dermal, inhalation) ``Group E'' not applicable not applicable
----------------------------------------------------------------------------------------------------------------
\1\ The reference to the FQPA Safety Factor refers to any additional safety factor retained due to concerns
unique to the FQPA.
\2.\ The HIARC document (dated 9/2/99) table incorrectly lists this as rat.

B. Exposure Assessment

1. Dietary exposure from food and feed uses. Tolerances have been
established (40 CFR 180.443) for the combined residues of myclobutanil,
[-butyl--(4-chlorophenyl)-1H-1,2,4-triazole-1-
propanenitrile] plus its alcohol metabolite [-(3-
hydroxybutyl)--(4-chlorophenyl)-1H-1,2,4-triazole-1-
propanenitrile] (free and bound), in or on a variety of raw
agricultural commodities at levels ranging from 25.0 ppm in raisin
waste to 0.02 ppm in cottonseed. Tolerances have also been established
(40 CFR 180.443(b)) for the combined residues of myclobutanil plus its
alcohol metabolite (free and bound) and diol metabolite [-(4-
chlorophenyl)--(3,4-dihydroxybutyl)-1H-1,2,4-triazole-1-
propanenitrile], in meat, milk, poultry and eggs, at levels ranging
from 0.02 ppm to 1.0 ppm. 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 one day
or single exposure. The Dietary Exposure Evaluation Model
(DEEM) analysis evaluated the individual food consumption as
reported by respondents in the USDA 1989-1992 nationwide Continuing
Surveys of Food Intake by Individuals (CSFII) and accumulated exposure
to the chemical for each commodity. The following assumptions were made
for the acute exposure assessments: The acute analysis was performed
for females 13-50 years old using published and proposed tolerance
level residues and 100% CT for all commodities. Therefore, the acute
risk was analyzed at the 95th percentile. The aPAD for females 13-50
years old is 0.6 mg/kg/day. For acute dietary risk, EPA's level of
concern is >100% aPAD. No acute dietary exposure analysis was performed
for the general U.S. population, including infants and children,
because no endpoint was chosen for these population subgroups.
ii. Chronic exposure. In conducting this chronic dietary risk
assessment the DEEM analysis evaluated the individual food
consumption as reported by respondents in the USDA 1989-1992 nationwide
Continuing Surveys of Food Intake by Individuals (CSFII) and
accumulated exposure to the chemical for each commodity. The following
assumptions were made for

[[Page 302]]

the chronic exposure assessments: The chronic analysis was performed
using published and proposed tolerance levels for all commodities. For
the chronic analysis, percent CT information was used for apples,
apricots, cherries, grapes, nectarines, peaches, pears, plums, and
cotton and 100% CT was assumed for all other commodities.
iii. Anticipated residue and percent crop treated information.
Section 408(b)(2)(F) 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 percent crop treated (PCT) as required by
section 408(b)(2)(F), EPA may require registrants to submit data on
PCT.
The Agency used PCT information as follows: apples at 40%, apricots
at 15%, cherries at 40%, grapes at 45%, nectarines at 20%, peaches at
10%, plums at 15% and cotton at 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 Generic Estimated Environmental Concentration
(GENEEC) or the Pesticide Root Zone/Exposure Analysis Modeling System
(PRZM/EXAMS) to estimate pesticide concentrations in surface water and
SCI-GROW, which predicts pesticide concentrations in groundwater. In
general, EPA will use GENEEC (a tier 1 model) before using PRZM/EXAMS
(a tier 2 model) for a screening-level assessment for surface water.
The GENEEC model is a subset of the PRZM/EXAMS model that uses a
specific high-end runoff scenario for pesticides. GENEEC incorporates a
farm pond scenario, while PRZM/EXAMS incorporate an index reservoir
environment in place of the previous pond scenario. 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. The primary use of these models by the Agency at this
stage is to provide a coarse screen for sorting out pesticides for
which it is highly unlikely that drinking water concentrations would
ever exceed human health levels of concern.
Since the models used are considered to be screening tools in the
risk assessment process, the Agency does not use estimated
environmental concentrations (EECs) from these models to quantify
drinking water exposure and risk as a %RfD or %PAD. Instead drinking
water levels of comparison (DWLOCs) are calculated and used as a point
of comparison against the model estimates of a pesticide's
concentration in water. DWLOCs are theoretical upper limits on a
pesticide's concentration in drinking water in light of total aggregate
exposure to a pesticide in food, and from residential uses. Since
DWLOCs address total aggregate exposure to myclobutanil they are
further discussed in the aggregate risk sections below.
Based on the GENEEC and SCI-GROW models the estimated environmental
concentrations (EECs) of myclobutanil for acute exposures are estimated
to be 115 parts per billion (ppb) for surface water and 2 ppb for
ground water. The EECs for chronic exposures are estimated to be 92 ppb
for surface water and 2 ppb for ground water.
3. From non-dietary exposure. Myclobutanil is currently registered
for use on the following residential non-dietary sites: Homeowner use
on turf, roses, flowers, shrubs and trees. The term ``residential
exposure'' is used in this document to refer to non- occupation,
nondietary exposure resulting from pesticide uses in residential
settings (e.g., pesticide uses for lawn and garden pest control, indoor
pest control, termiticides, and flea and tick control on pets.) The
risk assessment was conducted using the following exposure assumptions:
i. Residential handler exposure. Based on the residential use-
patterns associated with myclobutanil, there is potential for exposures
to handlers of myclobutanil. In order to present a high-end scenario of
residential exposure, it was assumed that one person would complete all
mixing, loading and application of myclobutanil. Exposure scenarios
were assessed, at the maximum application rate, for mixing, loading,
and application of a soluble concentrate product by trigger bottle
sprayer (treating ornamental plants), and by hose-end sprayer (treating
turfgrass) to represent the worst-case scenario for the proposed uses.
There are no chemical specific data available

[[Page 303]]

to support the residential use scenarios of myclobutanil. Therefore,
modeling (PHED v 1.1 surrogate table) was used to represent the highest
potential for exposure from homeowner application of myclobutanil.
ii. Residential post application exposure. Potential residential
exposures are expected following applications to lawns, ornamentals and
home garden sites. Chemical-specific data are available to determine
the potential risks from post-application activities. The registrant
submitted a dislodgeable foliar residue (DFR) study on grapes for
myclobutanil. Short-term post-application exposure estimates were done
using the study determined DFR of 0.175 g/cm\2\ (on day 0).
For intermediate-term post-application exposure, an average of DFRs
from day 0 through day 14 was used. The post-application risk
assessment is based on DFR data from the submitted study on grapes and
generic assumptions as specified by the recently revised Residential
SOPs.
Based on the use pattern, exposure to myclobutanil-treated
ornamentals is expected to be incidental and short-term. Both short-
and intermediate-term exposures are expected following lawn
applications of myclobutanil. Short-term aggregate post-application
exposure for the adult was done for dermal exposure to treated turf and
ornamentals. Since there is no intermediate-term exposure for the
residential handler, there is no aggregate intermediate-term exposure
for the adult.
Short-term, non-dietary ingestion exposure to toddlers is not
assessed since EPA did not detect an acute dietary or oral endpoint
applicable to infants and children. Therefore, EPA does not expect
short-term non-dietary exposure to pose a risk to infants and children.
The only short-term toddler exposure that was considered consists of
dermal post-application exposure. However, EPA determined that the
short-term dermal exposure should not be aggregated with the short-term
oral exposure because the toxic effects are different.
Additionally, intermediate-term, non-dietary ingestion exposure for
toddlers is possible and was assessed using the intermediate-term dose
and endpoint identified from the two generation reproduction toxicity
study in rats. Intermediate-term aggregate exposure for toddlers
combines non-dietary ingestion and dermal exposure from treated turf.
4. Cumulative exposure to substances with a common mechanism of
toxicity. Section 408(b)(2)(D)(v) 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.''
EPA does not have, at this time, available data to determine
whether myclobutanil has a common mechanism of toxicity with other
substances or how to include this pesticide in a cumulative risk
assessment. Unlike other pesticides for which EPA has followed a
cumulative risk approach based on a common mechanism of toxicity,
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 final rule
for Bifenthrin Pesticide Tolerances (62 FR 62961, November 26, 1997).

C. Safety Factor for Infants and Children

1. In general. FFDCA section 408 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 margin of exposure
(MOE) analysis or through using uncertainty (safety) factors in
calculating a dose level that poses no appreciable risk to humans.
2. Prenatal and postnatal sensitivity. There was no evidence of
increased susceptibility in the developmental toxicity studies with
rats and rabbits. The data from the 2-generation reproduction study in
rats provided no indication of quantitative or qualitative increased
susceptibility since maternal toxicity and reproductive toxicity
occurred at the same dose.
3. Conclusion. 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.
EPA determined that the 10X safety factor to protect infants and
children should be removed. The FQPA factor is removed because:
i. There are no toxicity or residential exposure data gaps in the
consideration of the FQPA Safety Factor;
ii. There was no evidence of increased susceptibility in the
developmental toxicity studies with rats and rabbits and the 2-
generation reproduction study in rats provided no indication of
quantitative or qualitative increased susceptibility since maternal
toxicity and reproductive toxicity occurred at the same dose;
iii. A developmental neurotoxicity study is not required because
neurotoxic compounds of similar structure were not identified and there
was no evidence of neurotoxicity in the current toxicity data base; and
iv. The exposure assessments will not underestimate the potential
dietary (food and drinking water) and residential (non-occupational)
exposures for infants and children from the use of myclobutanil.

D. Aggregate Risks and Determination of Safety

To estimate total aggregate exposure to a pesticide from food,
drinking water, and residential uses, the Agency calculates DWLOCs
which are used as a point of comparison against the model estimates of
a pesticide's concentration in water (EECs). DWLOC values are not
regulatory standards for drinking water. DWLOCs 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 + chronic non-dietary, non-occupational 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 Liters (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.

[[Page 304]]

When EECs for surface water and groundwater are less than the
calculated DWLOCs, OPP concludes with reasonable certainty that
exposures to myclobutanil in drinking water (when considered along with
other sources of exposure for which OPP has reliable data) would not
result in unacceptable levels of aggregate human health risk at this
time. Because OPP 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, OPP will reassess the potential impacts of
myclobutanil on drinking water as a part of the aggregate risk
assessment process.
1. Acute risk. Using the exposure assumptions discussed in this
unit for acute exposure, the acute dietary exposure from food to
myclobutanil will occupy 2% of the aPAD for females 13 years and older.
In addition, despite the potential for acute dietary exposure to
myclobutanil in drinking water, after calculating DWLOCs and comparing
them to conservative model estimated environmental concentrations of
myclobutanil in surface and ground water, EPA does not expect the
aggregate exposure to exceed 100% of the aPAD, as shown in the
following Table 2:

Table 2.--Aggregate Risk Assessment for Acute Exposure to myclobutanil
----------------------------------------------------------------------------------------------------------------
Surface Ground
Population Subgroup aPAD (mg/ %aPAD Water EEC Water EEC Acute DWLOC
kg) (Food) (ppb) (ppb) (ppb)
----------------------------------------------------------------------------------------------------------------
Females (13 to 50 years) 0.60 2 115 2 18000
----------------------------------------------------------------------------------------------------------------

2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that exposure to
myclobutanil from food will utilize 18% of the cPAD for the U.S.
population, 50% of the cPAD for infants 1 year old and 54% of the cPAD
for children 1 to 6 years old. There are no residential uses for
myclobutanil that result in chronic residential exposure to
myclobutanil. In addition, despite the potential for chronic dietary
exposure to myclobutanil in drinking water, after calculating DWLOCs
and comparing them to conservative model estimated environmental
concentrations of myclobutanil in surface and ground water, EPA does
not expect the aggregate exposure to exceed 100% of the cPAD, as shown
in the following Table 3:

Table 3.--Aggregate Risk Assessment for Chronic (Non- Cancer) Exposure to myclobutanil
----------------------------------------------------------------------------------------------------------------
Surface Ground
Population Subgroup cPAD mg/kg/ %cPAD Water EEC Water EEC Chronic
day (Food) (ppb) (ppb) DWLOC (ppb)
----------------------------------------------------------------------------------------------------------------
U.S. Population 0.025 18 31 2 720
All infants (1 year old) 0.025 50 31 2 130
Children 1 to 6 years 0.025 54 31 2 120
Children 7 to 12 years 0.025 27 31 2 180
----------------------------------------------------------------------------------------------------------------

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). EPA has determined that
oral and dermal exposures can not be aggregated due to differences in
the toxicological endpoints via the oral (developmental study) and
dermal routes. Therefore, short-term aggregate risk is captured by
assessment of acute risk above.
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.
Using the exposure assumptions described in this unit for
intermediate-term exposures, EPA has concluded that food and
residential exposures aggregated result in aggregate MOEs of 650 for
the U.S. population and 300 for infants and children. These aggregate
MOEs do not exceed the Agency's level of concern for aggregate exposure
to food and residential uses. In addition, intermediate-term DWLOCs
were calculated and compared to the EECs for chronic exposure of
myclobutanil in ground water and surface water. After calculating
DWLOCs and comparing them to the EECs for surface and ground water, EPA
does not expect intermediate-term aggregate exposure to exceed the
Agency's level of concern, as shown in the following Table 4:

Table 4.--Aggregate Risk Assessment for Intermediate-Term Exposure to myclobutanil
----------------------------------------------------------------------------------------------------------------
Aggregate Aggregate
MOE (Food + Level of Surface Ground Intermediate-
Population Subgroup Concern Water EEC Water EEC Term DWLOC
Residential) (LOC) (ppb) (ppb) (ppb)
----------------------------------------------------------------------------------------------------------------
U.S. Population 650 100 31 2 3000
Infants and Children 300 100 31 2 670
----------------------------------------------------------------------------------------------------------------

[[Page 305]]

5. Aggregate cancer risk for U.S. population. Myclobutanil is not
carcinogenic in either the rat or mouse and, therefore, is not expected
to pose a cancer risk to humans.
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

An adequate enforcement method (Rohm and Haas Method 34S-88-10) is
available to enforce the proposed tolerances. Quantitation is by GLC
using a nitrogen/phosphorus detector for myclobutanil and an electron
capture detector (Ni63) for residues measured as the alcohol
metabolite. The method may be requested from: Calvin Furlow, PRRIB,
IRSD (7502C), Office of Pesticide Programs, Environmental Protection
Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460; telephone
number: (703) 305-5229; e-mail address: furlow.calvin@epa.gov.

B. International Residue Limits

There are no CODEX, Canadian, or Mexican Maximum Residue Limits
(MRL) for myclobutanil on sugar beets. Thus, harmonization is not an
issue for this section 18.

C. Conditions

For permanent tolerances and a section 3 registration, the
petitioner must submit adequate residue field trial data. A final
decision on the appropriate tolerance levels will be withheld pending
submission of the requisite residue data. The submitted residue data
support a 28-day PHI. No processed commodity data were submitted in
support of the emergency exemption request. Therefore, in order to
represent the worst case scenario, maximum theoretical concentration
factors were used to determine the appropriate tolerances on sugar beet
processed commodities. Adequate processed commodity data must be
submitted for registration and permanent tolerances. Once these data
are submitted and reviewed, EPA will determine if tolerances on sugar
beet processed commodities are needed.

VI. Conclusion

Therefore, the tolerance is established for combined residues of
myclobutanil, in or on beet, sugar, roots at 0.05 ppm; beet, sugar,
tops at 1.0 ppm; beet, sugar, dried pulp at 1.0 ppm; beet, sugar,
molasses at 1.0 ppm; and beet, sugar, refined sugar at 0.70 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 of 1996, EPA will continue to use those
procedures, with appropriate adjustments, until the necessary
modifications can be made. The new section 408(g) 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), as was provided in the old FFDCA sections 408 and 409.
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 control number OPP-301085 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 March 5,
2001.
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 issues(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 (1900),
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460. You may also deliver your request to the Office
of the Hearing Clerk in Rm. C400, Waterside Mall, 401 M St., SW.,
Washington, DC 20460. 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) 260-4865.
2. Tolerance fee payment. If you file an objection or request a
hearing, you must also pay the fee prescribed by 40 CFR 180.33(i) or
request a waiver of that fee pursuant to 40 CFR 180.33(m). You must
mail the fee to: EPA Headquarters Accounting Operations Branch, Office
of Pesticide Programs, P.O. Box 360277M, Pittsburgh, PA 15251. Please
identify the fee submission by labeling it ``Tolerance Petition Fees.''
EPA is authorized to waive any fee requirement ``when in the
judgement of the Administrator such a waiver or refund is equitable and
not contrary to the purpose of this subsection.'' For additional
information regarding the waiver of these fees, you may contact James
Tompkins by phone at (703) 305-5697, by e-mail at tompkins.jim@epa.gov,
or by mailing a request for information to Mr. Tompkins at Registration
Division (7505C), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460.
If you would like to request a waiver of the tolerance objection
fees, you must mail your request for such a waiver to: James Hollins,
Information Resources and Services Division (7502C), Office of
Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460.
3. 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 Unit I.B.2. Mail your
copies, identified by the docket control number OPP-301085, 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.
In person or by courier, bring a copy to the location of the PIRIB
described in Unit I.B.2. You may also send an electronic copy of your
request via e-mail to: opp-docket@epa.gov. 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 file format or ASCII
file format. Do not

[[Page 306]]

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 issues(s) in the manner sought
by the requestor would be adequate to justify the action requested (40
CFR 178.32).

VIII. Regulatory Assessment Requirements

This final rule establishes time limited tolerances under FFDCA
section 408. 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).
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 prior consultation
as specified by Executive Order 13084, entitled Consultation and
Coordination with Indian Tribal Governments (63 FR 27655, May 19,
1998); special considerations as required by Executive Order 12898,
entitled Federal Actions to Address Environmental Justice in Minority
Populations and Low- Income Populations (59 FR 7629, February 16,
1994); or require 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 FFDCA section 408, such as the tolerances 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 FFDCA section 408(n)(4).

IX. Submission to Congress and the Comptroller General

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: December 19, 2000.
James Jones,
Director, Registration Division, Office of Pesticide Programs.

Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

1. The authority citation for part 180 continues to read as
follows:

Authority: 21 U.S.C. 321(q), 346(a) and 371.

2. Section 180.443 is amended by alphabetically adding commodities
to the table in paragraph (b) to read as follows:

Sec. 180.443 Myclobutanil; tolerances for residues.

* * * * *
(b) * * *

------------------------------------------------------------------------
Expiration/
Commodity Parts per million revocation date
------------------------------------------------------------------------
* * * * *
Beet, sugar, dried pulp 1.0 12/31/02
Beet, sugar, molasses 1.0 12/31/02
Beet, sugar, refined sugar 0.70 12/31/02
Beet, sugar, roots 0.05 12/31/02
Beet, sugar, tops 1.0 12/31/02
* * * * *
------------------------------------------------------------------------

* * * * *
[FR Doc. 01-26 Filed 1-2-01; 8:45 am]
BILLING CODE 6560-50-S

Myclobutanil; Pesticide Tolerances for Emergency Exemptions

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