[Federal Register Volume 63, Number 179 (Wednesday, September 16, 1998)]
[Rules and Regulations]
[Pages 49472-49479]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-24845]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-300705; FRL-6025-1]
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 artichokes, asparagus, and
peppers (bell and non-bell). This action is in response to EPA's
granting of emergency exemptions under section 18 of the Federal
Insecticide, Fungicide, and Rodenticide Act authorizing use of the
pesticide on artichokes, asparagus, and peppers (bell and non-bell) in
California (all three commodities), Michigan (asparagus) and New Mexico
(peppers). This regulation establishes a maximum permissible level for
residues of myclobutanil in these food commodities pursuant to section
408(l)(6) of the Federal Food, Drug, and Cosmetic Act, as amended by
the Food Quality Protection Act of 1996. These tolerances will expire
and are revoked on July 31, 2000.
DATES: This regulation is effective September 16, 1998. Objections and
requests for hearings must be received by EPA on or before November 16,
1998.
ADDRESSES: Written objections and hearing requests, identified by the
docket control number, [OPP-300705], must be submitted to: Hearing
Clerk (1900), Environmental Protection Agency, Rm. M3708, 401 M St.,
SW., Washington, DC 20460. Fees accompanying objections and hearing
requests shall be labeled ``Tolerance Petition Fees'' and forwarded to:
EPA Headquarters Accounting Operations Branch, OPP (Tolerance Fees),
P.O. Box 360277M, Pittsburgh, PA 15251. A copy of any objections and
hearing requests filed with the Hearing Clerk identified by the docket
control number, [OPP-300705], must also be submitted to: Public
Information and Records Integrity Branch, Information Resources and
Services Division (7502C), Office of Pesticide Programs, Environmental
Protection Agency, 401 M St., SW., Washington, DC 20460. In person,
bring a copy of objections and hearing requests to Rm. 119, CM #2, 1921
Jefferson Davis Hwy., Arlington, VA.
A copy of objections and hearing requests filed with the Hearing
Clerk may also be submitted electronically by sending electronic mail
(e-mail) to: [email protected]. Copies of objections and
hearing requests must be submitted as an ASCII file avoiding the use of
special characters and any form of encryption. Copies of objections and
hearing requests will also be accepted on disks in WordPerfect 5.1/6.1
file format or ASCII file format. All copies of objections and hearing
requests in electronic form must be identified by the docket control
number [OPP-300705]. No Confidential Business Information (CBI) should
be submitted through e-mail. Electronic copies of objections and
hearing requests on this rule may be filed online at many Federal
Depository Libraries.
FOR FURTHER INFORMATION CONTACT: By mail: David Deegan, Registration
Division (7505C), Office of Pesticide Programs, Environmental
Protection Agency, 401 M St., SW., Washington, DC 20460. Office
location, telephone number, and e-mail address: Crystal Mall #2, 1921
Jefferson Davis Hwy., Arlington, VA, (703) 308-9358, e-mail:
[email protected].
SUPPLEMENTARY INFORMATION: EPA, on its own initiative, pursuant to
section 408(e) and (l)(6) of the Federal Food, Drug, and Cosmetic Act
(FFDCA), 21 U.S.C. 346a(e) and (l)(6), is establishing tolerances for
the combined residues of the fungicide myclobutanil, in or on
artichokes at 1.0 parts per million (ppm), asparagus at 0.02 ppm, and
on peppers (bell and non-bell) at 1.0 ppm. These tolerances will expire
and are revoked on July 31, 2000. EPA will publish a document in the
Federal Register to remove the revoked tolerances from the Code of
Federal Regulations.
I. Background and Statutory Authority
The Food Quality Protection Act of 1996 (FQPA) (Pub. L. 104-170)
was signed into law August 3, 1996. FQPA amends both the Federal Food,
Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 301 et seq., and the Federal
Insecticide, Fungicide, and Rodenticide Act (FIFRA), 7 U.S.C. 136 et
seq. The FQPA amendments went into effect immediately. Among other
things, FQPA amends FFDCA to bring all EPA pesticide tolerance-setting
activities under a new section 408 with a new safety standard and new
procedures. These activities are described below and discussed in
greater detail in the final rule establishing the time-limited
tolerance associated with the emergency exemption for use of
propiconazole on sorghum (61 FR 58135, November 13, 1996)(FRL-5572-9).
New 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 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 FQPA. EPA has established regulations governing such
emergency exemptions in 40 CFR part 166.
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.
Because decisions on section 18-related tolerances must proceed
before EPA reaches closure on several policy issues relating to
interpretation and implementation of the FQPA, EPA does
[[Page 49473]]
not intend for its actions on such tolerance to set binding precedents
for the application of section 408 and the new safety standard to other
tolerances and exemptions.
II. Emergency Exemption for Use of Myclobutanil on Artichokes,
Asparagus, and Peppers (Bell and Non-bell), and FFDCA Tolerances
The state of California requested specific exemptions for the use
of myclobutanil on artichokes to control powdery mildew, on asparagus
to control asparagus rust, and bell and non-bell peppers to control
powdery mildew. Michigan requested a specific exemption for use of
myclobutanil on asparagus to control asparagus rust. New Mexico
requested a specific exemption for the use of myclobutanil on bell and
non-bell peppers to control powdery mildew.
EPA has authorized under FIFRA section 18 the use of myclobutanil
on artichoke to control powdery mildew in California, on asparagus to
control asparagus rust in California and Michigan, and on peppers (bell
and non-bell) for control of powdery mildew in California and New
Mexico. After having reviewed these submissions, 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
artichoke, asparagus, and bell and non-bell peppers. In doing so, EPA
considered the new safety standard in FFDCA section 408(b)(2), and EPA
decided that the necessary tolerances under FFDCA section 408(l)(6)
would be consistent with the new 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 under section 408(e),
as provided in section 408(l)(6). Although these tolerances will expire
and are revoked on July 31, 2000, under FFDCA section 408(l)(5),
residues of the pesticide not in excess of the amounts specified in the
tolerances remaining in or on artichoke, asparagus, and peppers (bell
and non-bell) after that date will not be unlawful, provided the
pesticide is applied in a manner that was lawful under FIFRA. 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 artichoke, asparagus,
or on bell and non-bell peppers or whether permanent tolerances for
these uses would be 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 States other
than those already detailed within this document to use this pesticide
on these crops under section 18 of FIFRA without following all
provisions of 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 above.
III. Risk Assessment and Statutory Findings
EPA performs a number of analyses to determine the risks from
aggregate exposure to pesticide residues. First, EPA determines the
toxicity of pesticides based primarily on toxicological studies using
laboratory animals. These studies address many adverse health effects,
including (but not limited to) reproductive effects, developmental
toxicity, toxicity to the nervous system, and carcinogenicity. Second,
EPA examines exposure to the pesticide through the diet (e.g., food and
drinking water) and through exposures that occur as a result of
pesticide use in residential settings.
A. Toxicity
1. Threshold and non-threshold effects. For many animal studies, a
dose response relationship can be determined, which provides a dose
that causes adverse effects (threshold effects) and doses causing no
observed effects (the ``no-observed effect level'' or ``NOEL'').
Once a study has been evaluated and the observed effects have been
determined to be threshold effects, EPA generally divides the NOEL from
the study with the lowest NOEL by an uncertainty factor (usually 100 or
more) to determine the Reference Dose (RfD). The RfD is a level at or
below which daily aggregate exposure over a lifetime will not pose
appreciable risks to human health. An uncertainty factor (sometimes
called a ``safety factor'') of 100 is commonly used since it is assumed
that people may be up to 10 times more sensitive to pesticides than the
test animals, and that one person or subgroup of the population (such
as infants and children) could be up to 10 times more sensitive to a
pesticide than another. In addition, EPA assesses the potential risks
to infants and children based on the weight of the evidence of the
toxicology studies and determines whether an additional uncertainty
factor is warranted. Thus, an aggregate daily exposure to a pesticide
residue at or below the RfD (expressed as 100% or less of the RfD) is
generally considered acceptable by EPA. EPA generally uses the RfD to
evaluate the chronic risks posed by pesticide exposure. For shorter
term risks, EPA calculates a margin of exposure (MOE) by dividing the
estimated human exposure into the NOEL from the appropriate animal
study. Commonly, EPA finds MOEs lower than 100 to be unacceptable. This
100-fold MOE is based on the same rationale as the 100-fold uncertainty
factor.
Lifetime feeding studies in two species of laboratory animals are
conducted to screen pesticides for cancer effects. When evidence of
increased cancer is noted in these studies, the Agency conducts a
weight of the evidence review of all relevant toxicological data
including short-term and mutagenicity studies and structure activity
relationship. Once a pesticide has been classified as a potential human
carcinogen, different types of risk assessments (e.g., linear low dose
extrapolations or MOE calculation based on the appropriate NOEL) will
be carried out based on the nature of the carcinogenic response and the
Agency's knowledge of its mode of action.
2. Differences in toxic effect due to exposure duration. The
toxicological effects of a pesticide can vary with different exposure
durations. EPA considers the entire toxicity data base, and based on
the effects seen for different durations and routes of exposure,
determines which risk assessments should be done to assure that the
public is adequately protected from any pesticide exposure scenario.
Both short and long durations of exposure are always considered.
Typically, risk assessments include ``acute,'' ``short-term,''
``intermediate term,'' and ``chronic'' risks. These assessments are
defined by the Agency as follows.
Acute risk, by the Agency's definition, results from 1-day
consumption of food and water, and reflects toxicity which could be
expressed following a single oral exposure to the pesticide residues.
High end exposure to food and water residues are typically assumed.
[[Page 49474]]
Short-term risk results from exposure to the pesticide for a period
of 1-7 days, and therefore overlaps with the acute risk assessment.
Historically, this risk assessment was intended to address primarily
dermal and inhalation exposure which could result, for example, from
residential pesticide applications. However, since enaction of FQPA,
this assessment has been expanded to include both dietary and non-
dietary sources of exposure, and will typically consider exposure from
food, water, and residential uses when reliable data are available. In
this assessment, risks from average food and water exposure, and high-
end residential exposure, are aggregated. High-end exposures from all 3
sources are not typically added because of the very low probability of
this occurring in most cases, and because the other conservative
assumptions built into the assessment assure adequate protection of
public health. However, for cases in which high-end exposure can
reasonably be expected from multiple sources (e.g. frequent and
widespread homeowner use in a specific geographical area), multiple
high-end risks will be aggregated and presented as part of the
comprehensive risk assessment/characterization. Since the toxicological
endpoint considered in this assessment reflects exposure over a period
of at least 7 days, an additional degree of conservatism is built into
the assessment; i.e., the risk assessment nominally covers 1-7 days
exposure, and the toxicological endpoint/NOEL is selected to be
adequate for at least 7 days of exposure. (Toxicity results at lower
levels when the dosing duration is increased.)
Intermediate-term risk results from exposure for 7 days to several
months. This assessment is handled in a manner similar to the short-
term risk assessment.
Chronic risk assessment describes risk which could result from
several months to a lifetime of exposure. For this assessment, risks
are aggregated considering average exposure from all sources for
representative population subgroups including infants and children.
B. Aggregate Exposure
In examining aggregate exposure, FFDCA section 408 requires that
EPA take into account available and reliable information concerning
exposure from the pesticide residue in the food in question, residues
in other foods for which there are tolerances, residues in groundwater
or surface water that is consumed as drinking water, and other non-
occupational exposures through pesticide use in gardens, lawns, or
buildings (residential and other indoor uses). Dietary exposure to
residues of a pesticide in a food commodity are estimated by
multiplying the average daily consumption of the food forms of that
commodity by the tolerance level or the anticipated pesticide residue
level. The Theoretical Maximum Residue Contribution (TMRC) is an
estimate of the level of residues consumed daily if each food item
contained pesticide residues equal to the tolerance. In evaluating food
exposures, EPA takes into account varying consumption patterns of major
identifiable subgroups of consumers, including infants and children.
The TMRC is a ``worst case'' estimate since it is based on the
assumptions that food contains pesticide residues at the tolerance
level and that 100% of the crop is treated by pesticides that have
established tolerances. If the TMRC exceeds the RfD or poses a lifetime
cancer risk that is greater than approximately one in a million, EPA
attempts to derive a more accurate exposure estimate for the pesticide
by evaluating additional types of information (anticipated residue data
and/or percent of crop treated data) which show, generally, that
pesticide residues in most foods when they are eaten are well below
established tolerances.
Percent of crop treated estimates are derived from federal and
private market survey data. Typically, a range of estimates are
supplied and the upper end of this range is assumed for the exposure
assessment. By using this upper end estimate of percent of crop
treated, the Agency is reasonably certain that exposure is not
understated for any significant subpopulation group. Further, regional
consumption information is taken into account through EPA's computer-
based model for evaluating the exposure of significant subpopulations
including several regional groups, to pesticide residues. For this
pesticide, the most highly exposed population subgroup (non-nursing
infants <1 year old) was not regionally based.
IV. Aggregate Risk Assessment and Determination of Safety
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 the
combined residues of myclobutanil on artichokes at 1.0 ppm, asparagus
at 0.02 ppm, and peppers (bell and non-bell) at 1.0 ppm. EPA's
assessment of the dietary exposures and risks associated with
establishing the tolerance follows.
A. Toxicological Profile
EPA has evaluated the available toxicity data and considered its
validity, completeness, and reliability as well as the relationship of
the results of the studies to human risk. EPA has also considered
available information concerning the variability of the sensitivities
of major identifiable subgroups of consumers, including infants and
children. The nature of the toxic effects caused by myclobutanil are
discussed below.
1. Acute toxicity. None. For acute dietary risk, EPA has not
identified an acute dietary endpoint.
2. Short - and intermediate - term toxicity. For short-term dermal
Margin of Exposure (MOE) calculations, the Agency used the systemic
NOEL of 100 mg/kg/day from a 21-day dermal toxicity study in rats. This
dose was the highest tested in the study. The Agency did not identify
an inhalation endpoint.
For intermediate-term MOE calculations, the Agency used the NOEL of
10 miligrams/kilograms/day (mg/kg/day) from a 2-generation reproductive
toxicity study in rats. At the Lowest Effect Level (LEL) of 50 mg/kg/
day, there were decreases in pup body weight, an increased incidence in
the number of stillborns, and atrophy of the prostate and testes.
3. Chronic toxicity. EPA has established the RfD for myclobutanil
at 0.025 mg/kg/day. This RfD is based on a chronic feeding study in
rats using a NOEL of 2.5 mg/kg/day and an uncertainty factor of 100. At
the Lowest Observed Effect Level (LOEL) of 9.9 mg/kg/day there was
testicular atrophy.
4. Carcinogenicity. Myclobutanil has been classified as a Group E
chemical (no evidence of carcinogenicity for humans) by the Agency.
B. Exposures and Risks
1. From food and feed uses. Tolerances have been established (40
CFR 180.443) for the combined residues of myclobutanil alpha-butyl-
alpha-(4-chlorophenyl)-1H-1,2,4-triazole-1-propanenitrile plus its
alcohol metabolite alpha-(3-hydroxybutyl)-alpha-(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
[[Page 49475]]
(free and bound) and diol metabolite alpha-(4-chlorophenyl)-alpha-(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 and risks
from myclobutanil as follows:
i. Acute exposure and risk. 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.
ii. Chronic exposure and risk. In conducting this chronic dietary
risk assessment, EPA has made somewhat conservative assumptions -- with
the exception of bananas, all commodities having myclobutanil
tolerances will contain myclobutanil and metabolite residues and those
residues will be at the level of the established tolerance -- which
results in an overestimate of human dietary exposure. For bananas an
anticipated residue estimate was used. Percent crop-treated estimates
were utilized for selected commodities included in the assessment.
Thus, in making a safety determination for this tolerance, EPA is
taking into account this partially refined exposure assessment.
The existing myclobutanil tolerances (published, pending, and
including the necessary section 18 tolerances) result in an Anticipated
Residue Contribution (ARC) that is equivalent to the following
percentages of the RfD:
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ARCfood (mg/kg/
Population Subgroup day) %Rfd
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U.S. Population (48 states) 0.004283 17%
Nursing Infants (<1 year old) 0.006365 25%
Non-Nursing Infants (<1 year 0.018836 75%
old)
Children (1-6 years old) 0.011508 46%
Children (7-12 years old) 0.006924 28%
Northeast Region 0.004573 18%
Western Region 0.004880 19%
Hispanics 0.005066 20%
Non-Hispanic Others 0.004443 18%
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The subgroups listed above are: (1) the U.S. population (48
states); (2) those for infants and children; and, (3) the other
subgroups for which the percentage of the Rfd occupied is greater than
that occupied by the subgroup U.S. population (48 states).
2. From drinking water. Chronic exposure and risk Based on
information available to EPA, myclobutanil is persistent and not
considered mobile in soils with the exception of sandy soils. Data are
not available for its metabolite alpha-(3-hydroxybutyl)-alpha-(4-
chlorophenyl)-1H-1,2,4-triazole-1-propanenitrile. There is no
established Maximum Contaminant Level for residues of myclobutanil in
drinking water. No Health Advisory Levels for myclobutanil in drinking
water have been established. The ``Pesticides in Groundwater Database''
(EPA 734-12-92-001, September 1992) has no information concerning
myclobutanil.
EPA has estimated ground and surface water concentrations for
myclobutanil based on the label rate of 0.65 lbs active ingredient
(a.i.)/acre and assuming 15 applications per season. (The water numbers
were based on turf.) The surface water numbers are based on the results
of GENEEC model run. The ground water numbers are based on a screening
tool, SCI-GROW, which tends to overestimate the true concentrations in
the environment.
Surface water EEC based on the results of a GENEEC model run
Acute = 145.96 ppb (0.14596 ppm or mg/L)(maximum initial
concentration)
Chronic = 118.6 ppb (0.1186 ppm or mg/L)(average 56-day
concentration)
EPA divides the 90/56-day GENEEC value by 3 to obtain a value for
chronic risk assessment calculations. Therefore, the surface water
value for use in the chronic risk assessment would be 0.04 ppm or mg/L.
Ground water EEC (SCI-GROW estimate)
3.6 ppb (0.0036 ppm or mg/L) (use for both acute and chronic)
Chronic exposure from surface water is calculated below. Chronic
exposure from ground water is lower.
EPA has calculated drinking water levels of concern (DWLOCs) for
chronic (non-cancer) exposure to be 0.7 ppm for U.S. population, 0.6
ppm for Hispanics, and 0.06 ppm for non-nursing infants (<1 year old ).
To calculate the DWLOC for chronic (non-cancer) exposure relative to a
chronic toxicity endpoint, the chronic dietary food exposure (from
DRES) was subtracted from the RfD to obtain the acceptable chronic
(non-cancer) exposure to myclobutanil in drinking water.
The estimated average concentration of myclobutanil in surface
water is 0.04 ppm. Chronic concentrations in ground water are not
expected to be higher than the acute concentrations. The estimated
average concentrations of myclobutanil in surface water are less than
EPA's levels of concern for myclobutanil in drinking water as a
contribution to chronic aggregate exposure. Therefore, taking into
account the present uses and uses proposed in this action, EPA
concludes with reasonable certainty that residues of myclobutanil 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.
EPA bases this determination on a comparison of estimated
concentrations of myclobutanil in surface waters and ground waters to
back-calculated ``levels of concern'' for myclobutanil in drinking
water. These levels of concern in drinking water were determined after
EPA has considered all other non-occupational human exposures for which
it has reliable data, including all current uses, and uses considered
in this action. The estimates of myclobutanil in surface waters are
derived from water quality models that use conservative assumptions
(health-protective) regarding the pesticide transport from the point of
application to surface and ground water. Because EPA considers the
aggregate risk resulting from multiple exposure pathways associated
with a pesticide's uses, levels of concern 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.
3. From non-dietary exposure. Myclobutanil is currently registered
for outdoor residential and greenhouse use on annuals and perennials,
turf, shrubs, trees, and flowers. EPA has determined that these uses do
not constitute a chronic exposure scenario, but may constitute a short-
to intermediate-term exposure scenario (Note: the intermediate-term
potential exposure would come from Post-application (dermal for adult;
and dermal + ingestion of soil only, due to the persistence of the
pesticide in soil, for toddlers). Other intermediate-term exposure
scenarios are unlikely as dissipation is strongly influenced by the
growth of the grass which needs weekly mowing (more frequently in
spring) and most dissipation studies on lawns show considerable tailing
off of residues by day 3 or 4; thus, the expectation of significant
residues is very unlikely.
4. Homeowner-use Products. End-use products containing the active
ingredient, myclobutanil, are marketed for homeowner use. The homeowner
use with the greatest potential for exposure takes the form of small
scale lawn application (other additional
[[Page 49476]]
application uses are on roses, flowers, ornamental shrubs and trees) of
a soluble concentrate with a hose-end, backpack, or trigger bottle
sprayer. Application of these products is recommended at two week
intervals. Short-term (and not intermediate-term exposures, because of
the amount of time it takes to mix, load, and apply this product)
exposure is considered only. Short-term exposure, pre- and during
application, will be considered an aggregate potential exposure: a
summation of this exposure will include exposure levels for: the mixer
+ loader + applicator + Post-application on day zero (day of
application). Short- and intermediate-term exposure will be considered
during post-application (Note: Intermediate-term exposure is addressed
only during post-application scenarios).
5. Cumulative exposure to substances with 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.'' The Agency believes that ``available
information'' in this context might include not only toxicity,
chemistry, and exposure data, but also scientific policies and
methodologies for understanding common mechanisms of toxicity and
conducting cumulative risk assessments. For most pesticides, although
the Agency has some information in its files that may turn out to be
helpful in eventually determining whether a pesticide shares a common
mechanism of toxicity with any other substances, EPA does not at this
time have the methodologies to resolve the complex scientific issues
concerning common mechanism of toxicity in a meaningful way. EPA has
begun a pilot process to study this issue further through the
examination of particular classes of pesticides. The Agency hopes that
the results of this pilot process will increase the Agency's scientific
understanding of this question such that EPA will be able to develop
and apply scientific principles for better determining which chemicals
have a common mechanism of toxicity and evaluating the cumulative
effects of such chemicals. The Agency anticipates, however, that even
as its understanding of the science of common mechanisms increases,
decisions on specific classes of chemicals will be heavily dependent on
chemical specific data, much of which may not be presently available.
Although at present the Agency does not know how to apply the
information in its files concerning common mechanism issues to most
risk assessments, there are pesticides as to which the common mechanism
issues can be resolved. These pesticides include pesticides that are
toxicologically dissimilar to existing chemical substances (in which
case the Agency can conclude that it is unlikely that a pesticide
shares a common mechanism of activity with other substances) and
pesticides that produce a common toxic metabolite (in which case common
mechanism of activity will be assumed).
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.
C. Aggregate Risks and Determination of Safety for U.S. Population
1. Chronic aggregate exposure and risk. Using the partially refined
exposure assumptions described above, EPA has concluded that aggregate
exposure (food, water, and residential) to myclobutanil will not exceed
EPA's level of concern. For the U.S. population, 17% of the RfD is
occupied by dietary (food) exposure. The estimated average
concentrations of myclobutanil in surface and ground water are less
than EPA's levels of concern for myclobutanil in drinking water as a
contribution to chronic aggregate exposure. Therefore, EPA concludes
with reasonable certainty that residues of myclobutanil in drinking
water do not contribute significantly to the aggregate chronic human
health risk at the present time considering the present uses and uses
proposed in this action. EPA has determined that the outdoor registered
uses of myclobutanil would not fall under a chronic exposure scenario.
EPA concludes that there is a reasonable certainty that no harm will
result from aggregate chronic exposure to myclobutanil residues.
2. Short- and intermediate-term risk. The short-term NOEL for
dermal exposure is based on a dermal exposure toxicity study. Since the
NOEL is based on a dermal study, oral exposures generally cannot be
used directly to calculate a short-term aggregate exposure. However,
because EPA determined that a dermal absorption factor of 100% should
be used for risk assessment, oral exposures need not be multiplied by a
modifying factor (converted to dermal equivalents) so that they can be
compared to the dermal endpoint.
The chronic dietary exposure and calculated dietary MOE for the
U.S. Population is as follows: MOE= 23,000, based on ARC of 0.004283
mg/kg/day.
The intermediate-term exposure scenarios and calculated MOE for the
U.S.Population is as follows: MOE= 2,300, based on ARC of 0.004283 mg/
kg/day.
There is a potential for short-term exposure from drinking water.
However, as estimated average concentrations of myclobutanil in surface
and ground water are less than EPA's levels of concern for drinking
water as a contribution to chronic aggregate and acute aggregate
exposures, contribution to short-term exposure should not exceed EPA's
levels of concern either.
EPA concludes that short-term aggregate MOEs for adults are
acceptable considering the default assumptions used in the derivation
of exposure estimates and the fact that a LOEL was not identified in
the 28-day rat dermal toxicity study the highest dose tested (HDT) was
the NOEL in this study used to determine the MOE. Chemical-specific
dissipation data and residential use/usage information are required to
further refine these post-application exposure estimates.
D. Aggregate Cancer Risk for U.S. Population
Myclobutanil was classified by the Agency as a Group E chemical (no
evidence of carcinogenicity for humans). Thus, a cancer risk assessment
was not conducted.
E. Endocrine Disruptor Effects
EPA is required to develop a screening program to determine whether
certain substances (including all pesticides and inerts) ``may have an
effect in humans that is similar to an effect produced by a naturally
occurring estrogen, or such other endocrine effect....'' The Agency is
currently working with interested stakeholders, including other
government agencies, public interest groups, industry and research
scientists in developing a screening and testing program and a priority
setting scheme to implement this program. Congress has allowed 3 years
from the passage of FQPA (August 3, 1999) to implement this program. At
[[Page 49477]]
that time, EPA may require further testing of this active ingredient
and end use products for endocrine disrupter effects.
Based on the adverse testicular findings, and increase in the
number of stillborns, and a decrease in pup weight gain during
lactation, in the chronic toxicity and reproduction studies in rats,
myclobutanil should be considered as a candidate for evaluation as an
endocrine disruptor.
F. Aggregate Risks and Determination of Safety for Infants and Children
1. Safety factor for infants and children --i. In general. In
assessing the potential for additional sensitivity of infants and
children to residues of myclobutanil, EPA considered data from
developmental toxicity studies in the rat and rabbit and a two-
generation reproduction study in the rat. The developmental toxicity
studies are designed to evaluate adverse effects on the developing
organism resulting from pesticide exposure during prenatal development
to one or both parents. Reproduction studies provide information
relating to effects from exposure to the pesticide on the reproductive
capability of mating animals and data on systemic toxicity.
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 pre-and post-natal toxicity and the
completeness of the database 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. EPA believes that reliable data support using the standard MOE
and uncertainty factor (usually 100 for combined inter- and intra-
species variability)) and not the additional tenfold MOE/uncertainty
factor when EPA has a complete data base under existing guidelines and
when the severity of the effect in infants or children or the potency
or unusual toxic properties of a compound do not raise concerns
regarding the adequacy of the standard MOE/safety factor.
ii. Developmental toxicity studies. In the developmental study in
rats, the maternal (systemic) NOEL was 93.8 mg/kg/day, based on rough
hair coat, and salivation at the LOEL of 312.6 mg/kg/day. The
developmental (fetal) NOEL was 93.8 mg/kg/day based on incidences of
14th rudimentary and 7th cervical ribs at the LOEL of 312.6 mg/kg/day.
In the developmental toxicity study in rabbits, the maternal
(systemic) NOEL was 60 mg/kg/day, based on reduced weight gain,
clinical signs of toxicity and abortions at the LOEL of 200 mg/kg/day.
The developmental (fetal) NOEL was 60 mg/kg/day, based on increases in
number of resorptions, decreases in litter size, and a decrease in the
viability index at the LOEL of 200 mg/kg/day.
iii. Reproductive toxicity study. In the 2-generation reproductive
toxicity study in rats, the parental (systemic) NOEL was 2.5 mg/kg/day,
based on increased liver weights and liver cell hypertrophy at the LOEL
of 10 mg/kg/day. The developmental (pup) NOEL was 10 mg/kg/day, based
on decreased pup body weight during lactation at the LOEL of 50 mg/kg/
day. The reproductive (pup) NOEL was 10 mg/kg/day, based on the
increased incidence of stillborns, and atrophy of the testes,
epididymides, and prostate at the LEL of 50 mg/kg/day.
iv. Pre- and post-natal sensitivity. The pre- and post-natal
toxicology data base for myclobutanil is complete with respect to
current toxicological data requirements. Based on the developmental and
reproductive toxicity studies discussed above, for myclobutanil there
does not appear to be an extra sensitivity for pre- or post-natal
effects.
v. Conclusion. Based on the above, EPA concludes that reliable data
support use of the standard 100-fold uncertainty factor and that an
factor is not needed to protect the safety of infants and children.
2. Chronic risk. Using the partially-refined exposure assumptions
described above, EPA has concluded that aggregate exposure to
myclobutanil from food ranges from 25% of the RfD for nursing infants
(<1 year old), up to 75% for non-nursing infants (<1 year old). EPA
generally has no concern for exposures below 100% of the RfD because
the RfD represents the level at or below which daily aggregate dietary
exposure over a lifetime will not pose appreciable risks to human
health. Despite the potential for exposure to myclobutanil in drinking
water and from non-dietary, non-occupational exposure, EPA does not
expect the aggregate exposure to exceed 100% of the RfD. EPA concludes
that there is a reasonable certainty that no harm will result to
infants and children from aggregate exposure to myclobutanil residues.
3. Short- or intermediate-term risk. The short-term NOEL for dermal
exposure is based on a dermal exposure toxicity study. Since the NOEL
is based on a dermal study, oral exposures generally cannot be used
directly to calculate a short-term aggregate exposure. However, because
EPA determined that a dermal absorption factor of 100% should be used
for risk assessment, oral exposures need not be multiplied by a
modifying factor (converted to dermal equivalents) so that they can be
compared to the dermal endpoint.
The chronic dietary exposure and calculated dietary MOE for infants
(non-nursing, < 1 year old) is 5,300, based on ARC of 0.018836 mg/kg/
day.
The dermal residential exposure is 0.85 mg/kg/day (reentry). The
calculated dietary MOE for non-nursing infants (<1 year old) is 5,300.
For the short-term aggregate risk of the most highly exposed
subgroup (non-nursing infants (<1 year old)), the calculated MOE is
120. There is a potential for short-term exposure from drinking water.
However, as estimated average concentrations of myclobutanil in surface
and ground water are less than EPA's levels of concern for drinking
water as a contribution to chronic aggregate and acute aggregate
exposures, contribution to short-term exposure should not exceed EPA's
levels of concern either. EPA concludes that short-term aggregate MOEs
for non-nursing infants (<1 year old) are acceptable.
V. Other Considerations
A. Metabolism In Plants and Animals
The nature of the residue in plants is adequately understood. The
residue of concern is myclobutanil plus its alcohol metabolite (free
and bound), as specified in 40 CFR 180.443(a).
B. Analytical Enforcement Methodology
An adequate enforcement method is available to enforce the
established tolerances. Quantitation is by Gas Liquid Chromatography
(GLC) using an Nitrogen/Phosphorus detector for myclobu-tanil and an
Electron Capture detector (Ni63) for residues measured as
the alcohol metabolite.
C. Magnitude of Residues
Residues of myclobutanil and its alcohol metabolite are not
expected to exceed 1.0 ppm in/on artichoke, 0.02 ppm in/on asparagus,
and 1.0 ppm in/on peppers (bell and non-bell), as a result of these
section 18 uses. Secondary residues are not expected in animal
commodities as no feedstuffs are associated with these section 18 uses.
Meat/ milk/poultry/ egg tolerances have been established as a result of
other myclobutanil uses.
[[Page 49478]]
D. International Residue Limits
There are no Codex, Canadian or Mexican residue limits established
for myclobutanil and its metabolites on the commodities included in
these section 18 requests. Thus, harmonization is not an issue for
these section 18 actions.
E. Rotational Crop Restrictions.
Information concerning the likelihood of residues in rotational
crops is not currently available for myclobutanil, although such data
is expected to be submitted to EPA shortly. Until EPA has reviewed and
approved such data, the Agency has required that the following
restriction should be added to the label for approved section 18 uses:
Rally treated fields can be rotated at any time to crops which are
included on the Rally label. For crops not listed on the registered
label, do not plant new crops on treated fields for these periods:
leafy vegetables, small grains -- 120 days root vegetables, all other
crops -- 210 days.
VI. Conclusion
Therefore, the tolerance is established for combined residues of
myclobutanil in artichoke at 1.0 ppm, asparagus at 0.02 ppm, and bell
and non-bell peppers at 1.0 ppm.
VII. Objections and Hearing Requests
The new FFDCA section 408(g) provides essentially the same process
for persons to ``object'' to a tolerance regulation issued by EPA under
new section 408(e) and (l)(6) as was provided in the old section 408
and in section 409. However, the period for filing objections is 60
days, rather than 30 days. EPA currently has procedural regulations
which govern the submission of objections and hearing requests. These
regulations will require some modification to reflect the new law.
However, until those modifications can be made, EPA will continue to
use those procedural regulations with appropriate adjustments to
reflect the new law.
Any person may, by November 16, 1998, file written objections to
any aspect of this regulation and may also request a hearing on those
objections. Objections and hearing requests must be filed with the
Hearing Clerk, at the address given above (40 CFR 178.20). A copy of
the objections and/or hearing requests filed with the Hearing Clerk
should be submitted to the OPP docket for this rulemaking. The
objections submitted must specify the provisions of the regulation
deemed objectionable and the grounds for the objections (40 CFR
178.25). Each objection must be accompanied by the fee prescribed by 40
CFR 180.33(i). If a hearing is requested, the objections must include a
statement of the factual issues on which a hearing is requested, the
requestor's contentions on such issues, and a summary of any evidence
relied upon by the requestor (40 CFR 178.27). A request for a hearing
will be granted if the Administrator determines that the material
submitted shows the following: There is 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 in the manner sought by the requestor would be adequate
to justify the action requested (40 CFR 178.32). Information submitted
in connection with an objection or hearing request may be claimed
confidential by marking any part or all of that information as
Confidential Business Information (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.
VIII. Public Record and Electronic Submissions
EPA has established a record for this rulemaking under docket
control number [OPP-300705] (including any comments and data submitted
electronically). A public version of this record, including printed,
paper versions of electronic comments, which does not include any
information claimed as CBI, is available for inspection from 8:30 a.m.
to 4 p.m., Monday through Friday, excluding legal holidays. The public
record is located in Rm. 119 of the Public Information and Records
Integrity Branch, Information Resources and Services Division (7502C),
Office of Pesticide Programs, Environmental Protection Agency, Crystal
Mall #2, 1921 Jefferson Davis Highway, Arlington, VA.
Electronic comments may be sent directly to EPA at:
[email protected].
Electronic comments must be submitted as an ASCII file avoiding the
use of special characters and any form of encryption.
The official record for this rulemaking, as well as the public
version, as described above will be kept in paper form. Accordingly,
EPA will transfer any copies of objections and hearing requests
received electronically into printed, paper form as they are received
and will place the paper copies in the official rulemaking record which
will also include all comments submitted directly in writing. The
official rulemaking record is the paper record maintained at the
Virginia address in ``ADDRESSES'' at the beginning of this document.
IX. Regulatory Assessment Requirements
A. Certain Acts and Executive Orders
This final rule establishes tolerances under FFDCA section 408(d)
in response to a petition submitted to the Agency. The Office of
Management and Budget (OMB) has exempted these types of actions from
review under Executive Order 12866, entitled Regulatory Planning and
Review (58 FR 51735, October 4, 1993). 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) (Pub. L. 104-4). Nor does
it require any prior consultation as specified by Executive Order
12875, entitled Enhancing the Intergovernmental Partnership (58 FR
58093, October 28, 1993), or 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 in
accordance with Executive Order 13045, entitled Protection of Children
from Environmental Health Risks and Safety Risks (62 FR 19885, April
23, 1997).
B. Executive Order 12875
Under Executive Order 12875, entitled Enhancing Intergovernmental
Partnerships (58 FR 58093, October 28, 1993), EPA may not issue a
regulation that is not required by statute and that creates a mandate
upon a State, local or tribal government, unless the Federal government
provides the funds necessary to pay the direct compliance costs
incurred by those governments. If the mandate is unfunded, EPA must
provide to the Office of Management and Budget (OMB) a description of
the extent of EPA's prior consultation with representatives of affected
State, local and tribal governments, the nature of their concerns,
copies of any written communications from the governments, and a
statement supporting the need to issue the regulation. In addition,
[[Page 49479]]
Executive Order 12875 requires EPA to develop an effective process
permitting elected officials and other representatives of State, local
and tribal governments ``to provide meaningful and timely input in the
development of regulatory proposals containing significant unfunded
mandates.''
Today's rule does not create an unfunded federal mandate on State,
local or tribal governments. The rule does not impose any enforceable
duties on these entities. Accordingly, the requirements of section 1(a)
of Executive Order 12875 do not apply to this rule.
C. Executive Order 13084
Under Executive Order 13084, entitled Consultation and Coordination
with Indian Tribal Governments (63 FR 27655, May 19,1998), EPA may not
issue a regulation that is not required by statute, that significantly
or uniquely affects the communities of Indian tribal governments, and
that imposes substantial direct compliance costs on those communities,
unless the Federal government provides the funds necessary to pay the
direct compliance costs incurred by the tribal governments. If the
mandate is unfunded, EPA must provide OMB, in a separately identified
section of the preamble to the rule, a description of the extent of
EPA's prior consultation with representatives of affected tribal
governments, a summary of the nature of their concerns, and a statement
supporting the need to issue the regulation. In addition, Executive
Order 13084 requires EPA to develop an effective process permitting
elected and other representatives of Indian tribal governments ``to
provide meaningful and timely input in the development of regulatory
policies on matters that significantly or uniquely affect their
communities.''
Today's rule does not significantly or uniquely affect the
communities of Indian tribal governments. This action does not involve
or impose any requirements that affect Indian Tribes. Accordingly, the
requirements of section 3(b) of Executive Order 13084 do not apply to
this rule.
In addition, since these tolerances and exemptions that are
established on the basis of a petition under FFDCA section 408 (d),
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. Nevertheless, the Agency has
previously assessed whether establishing tolerances, exemptions from
tolerances, raising tolerance levels or expanding exemptions might
adversely impact small entities and concluded, as a generic matter,
that there is no adverse economic impact. The factual basis for the
Agency's generic certification for tolerance actions published on May
4, 1981 (46 FR 24950), and was provided to the Chief Counsel for
Advocacy of the Small Business Administration.
X. 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 the rule in the Federal Register. This 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 26, 1998.
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. 346a and 371.
2. In section 180.443, by adding new entries for artichokes,
asparagus, and peppers (bell and non-bell) in alphabetical order 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
------------------------------------------------------------------------
Artichoke....................... 1.0 7/31/00
Asparagus....................... 0.02 7/31/00
* *
*
Peppers (bell and non-bell)..... 1.0 7/31/00
* *
*
------------------------------------------------------------------------
* * * * *
[FR Doc. 98-24845 Filed 9-15-98; 8:45 am]
BILLING CODE 6560-50-F