[Federal Register Volume 63, Number 91 (Tuesday, May 12, 1998)]
[Rules and Regulations]
[Pages 26089-26097]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-12577]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-300647; FRL-5787-7]
RIN 2070-AB78
Myclobutanil; Pesticide Tolerance.
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation establishes a tolerance for the fungicide
myclobutanil [alpha-butyl-alpha-(4-chlorophenyl)-1H-1,2,4-triazole-1-
propanenitrile] and its metabolite alpha-(3-hydroxybutyl)-alpha-(4-
chlorophenyl)-1H-1,2,4-triazole-1-propanenitrile (free and bound) in or
on bananas (post-harvest). Rohm and Haas Company requested this
tolerance under the Federal Food, Drug and Cosmetic Act (FFDCA), as
amended by the Food Quality Protection Act of 1996 (FQPA) (Pub. L. 104-
170).
DATES: This regulation is effective May 12, 1998. Objections and
requests for hearings must be received by EPA on or before July 13,
1998.
ADDRESSES: Written objections and hearing requests, identified by the
docket control number, [OPP-300647], 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-300647], 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: opp-docket@epamail.epa.gov. 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 or
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-300647]. 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: Mary L. Waller, 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, Rm
247, 1921 Jefferson Davis Hwy., Arlington, VA, (703) 308-9354, e-mail:
waller.mary@epamail.epa.gov.
SUPPLEMENTARY INFORMATION: In the Federal Register of August 1, 1997
(62 FR 41379)(FRL-5732-4), EPA, issued a notice pursuant to section 408
of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a(e)
announcing the filing of pesticide petition (PP) 2E4141 for a tolerance
by Rohm and Haas Company, 100 Independence Mall
[[Page 26090]]
West, Philadelphia, PA 19106-2399. This notice included a summary of
the petition prepared by Rohm and Haas Company, the registrant. There
were no comments received in response to the notice of filing.
The petition requested that 40 CFR 180.443 be amended by
establishing a tolerance for combined residues of the fungicide
myclobutanil [alpha-butyl-alpha-(4-chlorophenyl)-1H-1,2,4-triazole-1-
propanenitrile] and its metabolite alpha-(3-hydroxybutyl)-alpha-(4-
chlorophenyl)-1H-1,2,4-triazole-1-propanenitrile (free and bound) in or
on bananas (post-harvest) at 4.0 parts per million (ppm).
I. Risk Assessment and Statutory Findings
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. . . .''
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.
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
three 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
[[Page 26091]]
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 was not
regionally based.
II. 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 a tolerance for myclobutanil
[alpha-butyl-alpha-(4-chlorophenyl)-1H-1,2,4-triazole-1-propanenitrile]
and its metabolite alpha-(3-hydroxybutyl)-alpha-(4-chlorophenyl)-1H-
1,2,4-triazole-1-propanenitrile (free and bound) on bananas (post-
harvest) at 4.0 ppm. EPA's assessment of the dietary exposures and
risks associated with establishing the tolerance follows.
A. Toxicological Data Base
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 studies. The primary eye irritation for the technical is
classified as toxicity category I. All other acute studies on the
technical were classified as either toxicity category III or IV. There
was a positive sensitizing reaction.
2. Subchronic toxicity testing-- i. Rats. A subchronic feeding
study in rats was conducted for 13 weeks. The NOEL was determined to be
1,000 ppm and the lowest observed effect level (LOEL) was 3,000 ppm
based on increased liver and kidney weights, hypertrophy and necrosis
in the liver, pigmentation in convoluted kidney tubules and vacuolated
adrenal cortex.
ii. Dogs. A subchronic feeding study in dogs conducted for 13 weeks
resulted in a NOEL of 10 ppm and an LOEL of 200 ppm. Technical
myclobutanil was tested at 0, 10, 200, 800, and 1,600 ppm (0, 0.34,
7.26, 29.13, and 56.80 milligrams/kilogram (mg/kg)/day for males and 0,
0.42, 7.88, 32.43 and 57.97 mg/kg/day for females). At 200 ppm, and
above, hepatocellular centrilobular or midzonal hypertrophy was
observed in males. At 800 ppm and above, the same effect was observed
in females. In addition, increases in alkaline phosphatase, in absolute
liver weights in both sexes and in relative liver weights in males were
observed. At 1,600 ppm, all the previous effects plus increases in
relative liver weights in females, a suggestion of mild red cell
destruction or mild anemia, and decreases in body weight and food
consumption (possibly related to palatability) were observed.
Subchronic dermal studies using a 40% active ingredient (ai)
formulation (40WP) and a 24.99% emulsifiable concentrate formulation
(2EC) of myclobutanil conducted in rats resulted in a NOEL for systemic
effects of 100 mg ai/kg/day, a NOEL for skin irritation of
10 mg ai/kg/day and an LEL of 100 mg ai/kg/day. The 2EC was applied at
either 1, 10 or 100 mg ai/kg and the 40WP applied at 100 mg ai/kg once
per day for a total of 19-20 treatments over a 4 week period. No
systemic effects were observed at any dose level for either
formulation. Microscopic changes, indicating irritation, were observed
in the skin.
3. Chronic toxicity studies. A 1-year dog feeding study was
conducted using doses of 0, 10, 100, 400 and 1,600 ppm (equivalent to
doses of 0, 0.34, 3.09, 14.28 and 54.22 mg/kg body weight (bwt)/day in
males and 0, 0.40, 3.83, 15.68 and 58.20 mg/kg bwt/day in females). The
NOEL is 100 ppm (3.09 mg/kg/day for males and 3.83 mg/kg/day for
females) based upon hepatocellular hypertrophy, increases in liver
weights, ``ballooned'' hepatocytes and increases in alkaline
phosphatase, SGPT and GGT, and possible slight hematological effects.
The LOEL is 400 ppm (14.28 mg/kg/day for males and 15.68 mg/kg/day for
females).
4. Carcinogenicity-- i. Mice. A carcinogenicity study in mice was
conducted by administering 90.4% ai test material in the diet at 0, 20,
100, or 500 ppm (0, 2.7, 13.7 or 70.2 mg/kg/day for males and 0, 3.2,
16.5, or 85.2 mg/kg/day for females) for 24 months. The NOEL was
determined to be 100 ppm (systemic) and the LOEL was 500 ppm (systemic)
based on increased MFO (male and female), increased SGPT (male) and
increased absolute and relative liver weights (male and female,
increased incidences and severity of centrilobular hepatocytic
hypertrophy, Kupffer cell pigmentation, periportal punctate vacuolation
and individual hepatocellular necrosis (male), and increased incidences
of focal hepatocellular alterations and multifocal hepatocellular
vacuolation (male and female). In this test, dose levels in females was
not high enough. In the following test, higher doses were tested (2,000
ppm; 393.5 mg/kg/day). No carcinogenic effects were observed.
[[Page 26092]]
A carcinogenicity study in mice was conducted for 18 months in
which myclobutanil technical (92.9% ai) was administered in the diet at
0 and 2,000 ppm (393.5 mg/kg/day). No NOEL was established. The LOEL
was 2,000 ppm (393.5 mg/kg/day) based on decreases in body weight and
body weight gain, increases in liver weights, hepatocellular
vacuolation, necrosis of single hypertrophied hepatocytes, yellow-brown
pigment in the Kupffer cells and cytoplasmic eosinophilia and
hypertrophy of the cells of the zona fasciculata area of the adrenal
cortex. Myclobutanil was not carcinogenic under the conditions of the
study.
ii. Rats. A carcinogenicity study in rats was conducted by
administering technical myclobutanil (92.9% ai) in the diet at doses of
0 and 2,500 ppm (125 mg/kg/day). No NOEL was established (refer to next
study). The LOEL was 2,500 ppm based on testicular atrophy and
decreases in testes weights, increases in the incidences of
centrilobular to midzonal hepatocellular enlargement and vacuolization
in the liver of both sexes, increases in bilateral aspermatogenesis in
the testes, increases in the incidence of hypospermia and cellular
debris in the epididymides, and increased incidence of arteritis/
periarteritis in the testes. No carcinogenic effects were observed.
A chronic feeding/carcinogenicity study was conducted in rats.
Technical (90.4% and 91.4% pure) myclobutanil was administered in the
diet for 24 months at 25/35/50, 100/140/200 and 400/560/800 ppm (2
weeks/2 weeks/to termination; 0, 2.49, 9.84 or 39.21 mg/kg/day for
males; 0, 3.23, 12.86, or 52.34 mg/kg/day for females). The NOEL was
2.49 mg/kg/day and the LOEL was 9.84 mg/kg/day based on a decrease in
testes weights and increase in testicular atrophy. Dosage rates were
not high enough (refer to previous study). No carcinogenic effects were
observed.
5. Developmental toxicity-- i. Rabbits. A teratology study was
conducted in rabbits at doses of 0, 20, 60 or 200 mg ai/kg/day
(technical myclobutanil; 90.4% ai) administered by oral gavage on days
7-19 of gestation which resulted in a maternal NOEL of 60 mg/kg/day and
a maternal LOEL of 200 mg/kg/day based on reduced body weight and body
weight gain during the dosing period and clinical signs of toxicity and
possibly abortions. The developmental NOEL was 60 mg/kg/day and the
developmental LOEL was 200 mg/kg/day based on increases in number of
resorptions, decreases in litter size and decrease in the viability
index.
ii. Rats. In a teratology study, rats were treated with dosages of
0, 31.26, 93.77, 312.58 and 468.87 mg/kg/day by oral gavage from
gestation days 6-15. The maternal NOEL was 93.8 mg/kg/day and the
maternal LOEL was 312.6 mg/kg/day based on observation of rough hair
coat and salivation at 312.6 mg/kg/day and salivation, alopecia,
desquamation and red exudate around mouth at 468.87 mg/kg/day. The
developmental NOEL was 93.8 mg/kg/day. The developmental LOEL was 312.6
mg/kg/day based on increased incidences of 14th rudimentary and 7th
cervical ribs.
6. Reproductive toxicity. A 2-generation rat reproduction study was
conducted with dosage rates of 0, 50, 200 and 1,000 ppm (equivalent to
0, 2.5, 10 and 50 mg/kg/day). The parental (systemic) NOEL was 50 ppm
(2.5 mg/kg/day) and the parental (systemic) LOEL was 200 ppm (10 mg/kg/
day) based on hepatocellular hypertrophy and increases in liver
weights. The reproductive toxicity NOEL was 200 ppm (10 mg/kg/day) and
reproductive toxicity LOEL was 1,000 ppm (50 mg/kg/day) based on an
increased incidence in the number of stillborns and atrophy of the
testes, epididymides and prostate. The developmental NOEL was 200 ppm
(10 mg/kg/day) and the developmental LOEL was 1,000 ppm (50 mg/kg/day)
based on a decrease in pup body weight gain during lactation.
7. Mutagenicity. A reverse mutation assay (Ames), point mutation in
CHO/HGPRT cells, in vitro and in vivo (mouse) cytogenetic assays,
unscheduled DNA synthesis and a dominant lethal mutation study in rats,
were conducted, all of which were negative for mutagenic effects.
8. Metabolism-- i. Mice. A metabolism study in mice demonstrated
that myclobutanil was rapidly absorbed and excreted. It was completely
eliminated by 96 hours. The chemical was extensively metabolized prior
to excretion with metabolic patterns similar for both sexes.
Disposition and metabolism after pulse administration is linear over
the dose range.
ii. Rats. In a metabolism study in rats, myclobutanil was
completely and rapidly absorbed. It was extensively metabolized and
rapidly and essentially completely excreted. Elimination of label from
plasma was biphasic and evenly distributed between urine and feces.
There was no tissue accumulation after 96 hours.
In another metabolism study in rats, at least 7 major metabolites
of myclobutanil were recovered and identified. The highest amounts of
radioactivity were found in the liver, kidneys, and large and small
intestines. There was no tissue accumulation.
9. Neurotoxicity. There have been no clinical neurotoxic signs or
other types of neurotoxicity observed in any of the evaluated
toxicology studies. The Hazard ID Assessment Review Committee did not
recommend that a developmental neurotoxicity study be required for
myclobutanil. The following information was considered in the weight-
of-evidence evaluation:
i. Myclobutanil does not appear to be a neurotoxic chemical.
ii. The toxicology profile for this chemical did not indicate that
there were any treatment-related effects on the central or peripheral
nervous system. No acute or subchronic neurotoxicity studies in rats or
delayed neuropathy studies in chickens were available for review so
there was no evaluation of the nervous system following perfusion.
iii. No evidence of developmental anomalies of the fetal nervous
system were observed in the prenatal developmental toxicity studies in
either rats or rabbits at maternally toxic oral doses up to 468.9 and
200 mg/kg/day, respectively.
10. Other toxicological considerations. Myclobutanil has a complete
data base and no other toxicological concerns have been identified in
the evaluated studies.
B. Toxicological Endpoints
1. Acute toxicity. EPA has determined that data do not indicate the
potential for adverse effects after a single dietary exposure.
2. Short - and intermediate - term toxicity. EPA has determined
that when short- and intermediate-term risk assessments are appropriate
for occupational and residential routes of exposure, the following
should be used. OPP recommended that the NOEL of 100 mg/kg/day, taken
from the 28-day dermal toxicity study in rats, be used for the short-
term dermal MOE calculations. This dose level was the highest tested in
the study. For intermediate-term MOE calculations, OPP recommended
using the NOEL of 10 mg/kg/day from the 2-generation rat study. Effects
seen at the LOEL in this study (50 mg/kg/day) were decreases in pup
body weight, an increased incidence in 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 [the chronic feeding study in
rats with a NOEL of 2.5 mg/kg/day and an uncertainty factor of 100.
There was testicular atrophy at the lowest observed effect level (LOEL)
of 9.9 mg/kg/day.
[[Page 26093]]
4. Carcinogenicity. Using its Guidelines for Carcinogen Risk
Assessment published September 24, 1986 (51 FR 33992), EPA has
classified myclobutanil as a Group E chemical--``no evidence of
carcinogenicity for humans''--based on the results of carcinogenicity
studies in two species. The doses tested are adequate for identifying a
cancer risk.
B. Exposures and Risks
1. From food and feed uses. Tolerances have been established (40
CFR 180.443) for myclobutanil [alpha-butyl-alpha-(4-chlorophenyl)-1H-
1,2,4-triazole-1-propanenitrile] and its 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.
Commodities include: almonds, apples, cherries, cotton seed, grapes,
stone fruits (except cherries) and tolerances for meat, milk, poultry
and eggs. In today's action, a tolerance will be established for
combined residues of myclobutanil and its metabolite in or on bananas
(post-harvest) at 4.0 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. The Toxicology Endpoint Selection
Committee did not identify an acute dietary toxicological endpoint and
stated that an acute dietary risk assessment is not required.
ii. Chronic exposure and risk. In conducting the chronic dietary
(food only) risk assessment, EPA has made several very conservative
assumptions. With the exceptions of bananas for which a level
representing residues in pulp rather than the whole banana was used and
selected commodities which were corrected for percent crop treated, all
commodities having myclobutanil tolerances will contain myclobutanil
and metabolite residues and those residues will be at the levels of the
established tolerances. For bananas, the level of 0.8 ppm was used in
the dietary risk assessment rather than the proposed tolerance of 4.0
ppm since residues in the pulp will not exceed 0.8 ppm. 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.
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: (a) that the data used
are reliable and provide a valid basis for showing the percentage of
food derived from a crop that is likely to contain residues; (b) that
the exposure estimate does not underestimate the exposure for any
significant subpopulation and; (c) where data on regional pesticide use
and food consumption are available, that the exposure estimate does not
understate exposure for any regional population. In addition, the
Agency must provide for periodic evaluation of any estimates used. To
provide for the periodic evaluation of these estimates of percent food
treated as required by the section 408(b)(2)(F), EPA may require
registrants to submit data on percent crop treated.
As indicated above, the Agency is required to determine the
reliability of the percent crop-treated data. Percent crop-treated
estimates are derived from federal and private market survey data.
Typically, a range is assumed for the exposure assessment. By using
this upper end estimate, the Agency is reasonably certain that the
exposure is not understated for any significant population sub-group.
Additionally, the DRES (Dietary Risk Evaluation System) modeling used
in estimating chronic dietary risk uses regional consumption groups
that are geographically based regions of the United States. None of
these subgroups exceeded the Agency's level of concern.
The existing myclobutanil tolerances (published, pending, and
including the necessary Section 18 tolerances) for crops other than
bananas and the anticipated residues on bananas result in an
Anticipated Residue Contribution (ARC) that is equivalent to the
following percentages of the RfD.
------------------------------------------------------------------------
Population Subgroup %RfD
------------------------------------------------------------------------
U.S. Population (48 states) 17
Nursing Infants (<1 year="" old)="" 25="" non-nursing="" infants=""><1 year="" old)="" 75="" children="" (1-6="" years="" old)="" 46="" children="" (7-12="" years="" old)="" 28="" northeast="" region="" 18="" western="" region="" 19="" hispanics="" 20="" non-hispanic="" others="" 18="" ------------------------------------------------------------------------="" the="" subgroups="" listed="" above="" are:="" (a)="" the="" u.s.="" population="" (48="" states),="" (b)="" those="" for="" infants="" and="" children,="" and="" (c)="" 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.="" based="" on="" information="" in="" the="" efed="" (environmental="" fate="" and="" effects="" division)="" one-liner="" database,="" myclobutanil="" is="" persistent="" and="" not="" considered="" mobile="" in="" soils="" with="" the="" exception="" of="" sandy="" soils.="" data="" are="" not="" available="" for="" its="" metabolite.="" 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''="" has="" no="" information="" concerning="" myclobutanil.="" estimates="" of="" ground="" and="" surface="" water="" concentrations="" for="" myclobutanil="" were="" determined="" based="" on="" the="" label="" rate="" of="" 0.65="" lbs.="" a.i./acre="" and="" assuming="" 15="" applications="" per="" season.="" although="" the="" requested="" tolerance="" is="" for="" bananas,="" these="" estimates="" were="" based="" on="" turf="" since="" it="" would="" more="" realistically="" estimate="" the="" concentrations="" in="" water.="" the="" surface="" water="" numbers="" are="" based="" on="" the="" results="" of="" a="" generic="" environmental="" concentration="" (geneec)="" model.="" the="" ground="" water="" numbers="" are="" based="" on="" a="" screening="" tool,="" sci-grow,="" which="" tends="" to="" overestimate="" the="" true="" concentration="" in="" the="" environment.="" for="" acute="" effects,="" the="" surface="" water="" eec="" was="" determined="" to="" be="" 0.14596="" ppm="" or="" mg/l="" (maximum="" initial="" concentration).="" for="" chronic="" effects="" the="" surface="" water="" eec="" was="" 0.1186="" ppm="" or="" mg/l="" (average="" 56-day="" concentration).="" current="" policy="" allows="" the="" 90/56-day="" geneec="" value="" to="" be="" divided="" 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.="" i.="" acute="" exposure="" and="" risk.="" the="" toxicology="" endpoint="" selection="" committee="" did="" not="" identify="" an="" acute="" dietary="" toxicological="" endpoint="" and="" stated="" than="" an="" acute="" dietary="" risk="" assessment="" is="" not="" required.="" ii.="" chronic="" exposure="" and="" risk.="" chronic="" exposure="" is="" calculated="" based="" on="" surface="" water.="" chronic="" exposure="" from="" ground="" water="" is="" lower.="" chronic="" exposure="" (mg/kg/day)="" is="" calculated="" by="" multiplying="" the="" concentration="" in="" water="" in="" mg/l="" by="" the="" daily="" consumption="" (2l/day="" for="" male="" and="" female="" adults="" and="" 1l/day="" for="" children)="" and="" dividing="" this="" figure="" by="" average="" weight="" (70="" kg="" for="" males,="" 60="" kg="" for="" females="" and="" 10="" kg="" for="" children).="" for="" adult="" males,="" exposure="" is="" 1.1="" x="">3 mg/kg/day; for adult
females, 1.3 x 10-3 mg/kg/day; and for children, 4.0 x 10-
3 mg/kg/day. Chronic risk (non-cancer) from surface water
was calculated to be 4.4% of the Rfd for males, 5.2% for females and
16% for children.
[[Page 26094]]
3. From non-dietary exposure. Myclobutanil is currently registered
for use on the following non-food sites: outdoor residential and
greenhouse use on annuals and perennials, turf, shrubs, trees and
flowers.
i. Acute exposure and risk. An acute toxicological endpoint was not
identified for myclobutanil.
ii. Chronic exposure and risk. HED has determined that these uses
do not constitute a chronic exposure scenario, but may constitute a
short- to intermediate-term exposure scenario.
iii. Short- and intermediate-term exposure and risk. The home use
of myclobutanil on turf has the greatest potential for exposure and was
used in estimating short-term risk. HED concluded that residential
intermediate-term exposure is not expected for handlers or persons re-
entering treated areas. Fungicide use on home lawns is limited,
restricted to certain parts of the country, and considered to be a
``rare, extra treatment'' in homeowner Do-It-Yourself programs. The
end-point selected for short-term risk assessment is from a 28-day
dermal study in rats; this dosing duration is expected to adequately
reflect the typical human exposures for this use. Maximum application
rates are calculated from the use directions on the label. Typical lawn
size of 13,000 ft2 is used in place of the high-end lawn
default value of 20,000 ft2. Post-application exposure
estimates assume that 10% of the application rate is available as
dislodgeable residue since the label states that the product is not
washed away by rain or sprinklers.
Currently there is no use/usage information source available to HED
for residential end-use products. Therefore, pertinent information is
unknown and assumptions are made for parameters such as: amount of
product applied, how often treatment is actually required; the number
of applications that are typically made; whether applications are
generally spot or full lawn treatments, etc. Similarly, a number of
assumptions and best estimates are made in assessing post-application
exposure, including: the duration and degree of activity in the treated
area by children and adults; the amount of product available to
dislodge and transfer to the skin during activity; and the amount of
product dissipation over time.
HED determined that there is potential for intermittent short-term
exposures to homeowners associated with typical end-product use of
myclobutanil. Three exposure scenarios with the greatest potential for
exposure are considered for application to home lawns: (a) loading and
application of granular product by hand held rotary granular spreader;
(b) mixing, loading and application of a soluble concentrate product by
low pressure handwand sprayer; and (c) mixing, loading, and application
of a soluble concentrate product by garden hose-end sprayer. Short-term
dermal exposure assessments using the ``Pesticide Handlers Exposure
Database'' surrogate data and risk calculations for homeowners resulted
in a short-term MOE of 460 for scenario 1, 260 for scenario 2 and 890
for scenario 3.
There is also the potential for post-application homeowner exposure
following applications to lawn and garden sites. There are no chemical-
specific data to use in assessing these potential exposures. Post-
application exposure is estimated and risk assessments performed using
typical transfer coefficients (Tc) and surrogate dislodgeable foliar
residues (DFR) derived from the application rate. Short-term post-
application exposure assessments and risk calculations for adults and
toddlers re-entering treated areas on the day of application resulted
in a short-term MOE of 350 for adult dermal exposure, 100 for toddler
dermal exposure, 1,600 for toddlers for non-dietary ingestion and 100
for combined dermal and non-dietary ingestion for toddlers. Dietary
ingestion is addressed in the discussion of aggregate risk.
Using these exposure assumptions for short-term risk assessments,
it is concluded that the MOEs that will result from the residential use
of myclobutanil do not exceed the level of concern.
4. 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. Acute risk. No acute dietary risks were identified.
2. Chronic risk. Using the partially refined exposure assumptions
described above, EPA has concluded that aggregate exposure to
myclobutanil from food will utilize 17% of the RfD for the U.S.
population. The major identifiable subgroup with the highest aggregate
exposure is non-nursing infants (<1 year="" old)="" which="" is="" discussed="" below.="" epa="" generally="" has="" no="" concern="" for="" exposures="" below="" 100%="" of="" the="" rfd="" because="" the="" rfd="" [[page="" 26095]]="" 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="" from="" aggregate="" exposure="" to="" myclobutanil="" residues.="" 3.="" short-="" and="" intermediate-term="" risk.="" short-="" and="" intermediate-term="" aggregate="" exposure="" takes="" into="" account="" chronic="" dietary="" food="" and="" water="" (considered="" to="" be="" a="" background="" exposure="" level)="" plus="" indoor="" and="" outdoor="" residential="" exposure.="" since="" short-term="" residential="" exposure="" scenarios="" are="" present,="" short-term="" aggregate="" moes="" for="" adults="" and="" children="" from="" the="" turf="" use="" were="" determined.="" the="" short-term="" aggregate="" moe="" for="" adults="" was="" 150="" and="" for="" children="" it="" was="" 94.="" although="" an="" moe="" of="" 94="" was="" calculated,="" this="" moe="" is="" acceptable="" based="" on="" conservative="" estimates="" of="" exposure.="" since="" worst="" case="" estimates="" were="" used="" in="" the="" calculations,="" the="" moe="" would="" be="" above="" 100="" under="" usual="" conditions="" of="" use.="" it="" was="" concluded="" that="" short-term="" aggregate="" moes="" for="" both="" adults="" and="" children="" are="" acceptable.="" this="" is="" based="" on="" the="" consideration="" of="" the="" conservative="" nature="" of="" the="" default="" assumptions="" for="" duration="" and="" degree="" of="" activity="" in="" treated="" areas="" by="" children="" and="" adults,="" amount="" of="" product="" available="" to="" dislodge="" and="" transfer="" to="" skin="" during="" activity,="" and="" amount="" of="" product="" dissipation="" over="" time="" which="" were="" used="" in="" the="" derivation="" of="" exposure="" estimates.="" the="" estimates="" were="" calculated="" using="" the="" maximum="" application="" rate="" and="" the="" assumption="" that="" 10%="" of="" the="" application="" rate="" is="" available="" as="" dislodgeable="" residue.="" both="" of="" these="" factors="" are="" likely="" overestimated.="" the="" fact="" that="" a="" loel="" was="" not="" identified="" in="" the="" 28-day="" rat="" dermal="" toxicity="" study="" used="" to="" determine="" the="" moe="" indicates="" an="" overestimate="" since="" the="" level="" used="" was="" the="" highest="" dose="" tested.="" additionally="" there="" are="" no="" indoor="" residential="" uses="" of="" myclobutanil;="" thus,="" indoor="" residential="" exposure="" is="" not="" a="" concern.="" d.="" aggregate="" cancer="" risk="" for="" u.s.="" population="" myclobutanil="" is="" classified="" as="" category="" e:="" not="" carcinogenic="" in="" two="" acceptable="" animal="" studies.="" e.="" aggregate="" risks="" and="" determination="" of="" safety="" for="" infants="" and="" children="" 1.="" safety="" factor="" for="" infants="" and="" children--="" 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="" maternal="" pesticide="" exposure="" gestation.="" 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="" 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.="" 2.="" developmental="" toxicity="" studies--="" i.="" rats.="" 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.="" ii.="" rabbits.="" 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.="" 3.="" reproductive="" toxicity="" study--="" rats.="" 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="" noel="" was="" 10="" mg/kg/day,="" based="" on="" the="" increased="" incidences="" of="" stillborns,="" and="" atrophy="" of="" the="" testes,="" epididymides,="" and="" prostate="" at="" the="" loel="" of="" 50="" mg/kg/day.="" 4.="" 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,="" there="" does="" not="" appear="" to="" be="" an="" extra="" sensitivity="" for="" pre-="" or="" post-natal="" effects.="" 5.="" acute="" risk.="" no="" acute="" dietary="" risk="" has="" been="" identified.="" 6.="" chronic="" risk.="" using="" the="" conservative="" exposure="" assumptions="" described="" above,="" epa="" has="" concluded="" that="" exposure="" to="" myclobutanil="" from="" food="" will="" utilize="" 25%="" (nursing="" infants="">< 1="" year="" old)="" and="" 75%="" (non-="" nursing="" infants="">< 1="" year="" old)="" of="" the="" rfd.="" the="" percent="" of="" the="" rfd="" that="" will="" be="" used="" by="" the="" food="" and="" water="" exposure="" for="" children="" 1-6="" years="" old="" is="" 62%="" and="" 21%="" for="" the="" u.s.="" population.="" 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.="" 7.="" short-="" or="" intermediate-term="" risk.="" intermediate-term="" risk="" is="" not="" expected="" since="" there="" is="" no="" expectation="" of="" intermediate-term="" exposure.="" short-term="" exposure="" scenarios="" are="" expected="" and="" the="" moes="" which="" were="" determined="" for="" aggregate="" short-term="" risk="" does="" not="" exceed="" hed's="" level="" of="" concern.="" it="" was="" concluded="" that="" there="" is="" a="" reasonable="" certainty="" that="" no="" harm="" will="" result="" from="" aggregate="" exposure="" to="" myclobutanil="" residues.="" 8.="" conclusion.="" epa="" concludes="" that="" reliable="" data="" support="" use="" of="" the="" 100-fold="" uncertainty="" factor="" and="" that="" an="" additional="" 10-fold="" factor="" is="" not="" needed="" to="" ensure="" the="" safety="" of="" infants="" and="" children="" from="" dietary="" exposure.="" iii.="" other="" considerations="" a.="" endocrine="" disrupter="" effects="" epa="" is="" required="" to="" develop="" a="" screening="" program="" to="" determine="" whether="" certain="" substances="" (including="" all="" pesticides="" and="" inerts)="" ``may="" have="" an="" [[page="" 26096]]="" 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="" the="" fqpa="" (august="" 3,="" 1999)="" to="" implement="" this="" program.="" at="" 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="" in="" the="" chronic="" toxicity="" and="" reproduction="" studies="" in="" rats,="" myclobutanil="" should="" be="" considered="" as="" a="" candidate="" for="" evaluation="" as="" an="" endocrine="" disrupter.="" b.="" metabolism="" in="" plants="" and="" animals="" 1.="" plants.="" based="" on="" the="" three="" metabolism="" studies="" on="" wheat,="" apples="" and="" grapes="" (which="" indicate="" a="" similar="" metabolic="" route="" for="" crops="" in="" three="" different="" crop="" groups),="" the="" nature="" of="" the="" residue="" in="" bananas="" is="" adequately="" understood.="" the="" residues="" of="" concern="" in="" bananas="" are="" myclobutanil="" [alpha-butyl-alpha-(4-chlorophenyl)-1h-1,2,4-triazole-1-="" propanenitrile]="" and="" its="" metabolite="" alpha-(3-hydroxybutyl)-alpha-(4-="" chlorophenyl)-1h-1,2,4-triazole-1-propanenitrile="" (free="" and="" bound).="" 2.="" animals.="" the="" nature="" of="" the="" residue="" in="" animals="" is="" adequately="" understood.="" the="" residues="" of="" concern="" in="" animal="" commodities="" except="" milk="" are="" myclobutanil="" and="" its="" metabolite="" alpha-(3-hydroxybutyl)-alpha-(4-="" chlorophenyl)-1h-1,2,4-triazole-1-propanenitrile="" (free).="" the="" residues="" of="" concern="" in="" milk="" are="" myclobutanil="" and="" its="" metabolites="" alpha-(3-="" hydroxybutyl)-alpha-(4-chlorophenyl)-1h-1,2,4-triazole-1-propanenitrile="" (free="" and="" bound)="" and="" alpha-(4-chlorophenyl)-alpha-(3,4-dihydroxybutyl)-="" 1h-1,2,4-triazole-1-propanenitrile.="" c.="" analytical="" enforcement="" methodology="" an="" adequate="" enforcement="" method,="" 34s-88-10,="" is="" available="" to="" enforce="" the="" tolerance="" on="" bananas.="" quantitation="" is="" by="" glc="" using="" a="" nitrogen/="" phosphorus="" detector="" for="" parent="" myclobutanil="" and="" an="" electron="" capture="" detector="">63) for residues measured as the alcohol
metabolite alpha-(3-hydroxybutyl)-alpha-(4-chlorophenyl)-1H-1,2,4-
triazole-1-propanenitrile. Enforcement methods for the established
tolerances on animal commodities are Methods 34S-88-22, 34S-88-15, 31S-
87-02, and 34S-88-21. These methods have been submitted for publication
in PAM II. The methods are available to anyone who is interested in
pesticide residue enforcement from: By mail, Calvin Furlow, Public
Information and Records Intregrity Branch, Information Resources and
Services Division (7502C), Office of Pesticide Programs, Environmental
Protection Agency, 401 M St., SW., Washington, DC 20460. Office
location and telephone number: Crystal Mall #2, Rm. 119FF, 1921
Jefferson Davis Hwy., (703) 305-5229.
D. Magnitude of Residues
The combined residues of myclobutanil and its metabolite alpha-(3-
hydroxybutyl)-alpha-(4-chlorophenyl)-1H-1,2,4-triazole-1-propanenitrile
(free and bound) resulting from the proposed use will not exceed 4.0
ppm in bananas (post-harvest). The tolerance on bananas is for the raw
agricultural commodity as defined in 40 CFR 180.1(j)(1). Both peel and
pulp are included. Crown tissue or stalk are excluded. For risk
assessment purposes, it was concluded that residues resulting from the
proposed use will not exceed 0.8 ppm in banana pulp.
E. Rotational Crop Restrictions.
Rotational crop studies are not required for uses of pesticides on
bananas.
F. International Residue Limits
There are no Codex, Canadian or Mexican residue limits established
for myclobutanil and its metabolites on bananas. Therefore, no
compatibility problems exist for the proposed tolerance on bananas.
IV. Conclusion
Therefore, the tolerance is established for the combined residues
of the fungicide myclobutanil [alpha-butyl-alpha-(4-chlorophenyl)-1H-
1,2,4-triazole-1-propanenitrile] and its metabolite alpha-(3-
hydroxybutyl)-alpha-(4-chlorophenyl)-1H-1,2,4-triazole-1-propanenitrile
(free and bound) in or on the raw agricultural commodity bananas (post-
harvest) at 4.0 ppm.
V. 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 July 13, 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 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.
VI. Public Docket
EPA has established a record for this rulemaking under docket
control number [OPP-300647] (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.,
[[Page 26097]]
Monday through Friday, excluding legal holidays. The public record is
located in Room 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:
opp-docket@epamail.epa.gov.
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.
VII. Regulatory Assessment Requirements
This final rule establishes a tolerance 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).
In addition, since these tolerances and exemptions that are
established on the basis of a petition under FFDCA section 408(d), such
as the tolerance in this final rule, do not require the issuance of a
proposed rule, the requirements of the Regulatory Flexibility Act (RFA)
(5 U.S.C. 601 et seq.) do not apply. 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 was published on
May 4, 1981 (46 FR 24950) and was provided to the Chief Counsel for
Advocacy of the Small Business Administration.
VIII. 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: April 23, 1998.
Peter Caulkins,
Acting 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. Section 180.443, is amended by adding and alphabetically
inserting into the table of paragraph (a) the commodity bananas (Post-
H) at 4.0 ppm to read as follows:
Sec. 180.443 Myclobutanil; tolerances for residues.
(a) General. * * *
------------------------------------------------------------------------
Commodity Parts per million
------------------------------------------------------------------------
* * * * *
Bananas (Post-H)..................................... 4.0
* * * * *
------------------------------------------------------------------------
* * * * *
[FR Doc. 98-12577 Filed 5-11-98; 8:45 am]
BILLING CODE 6560-50-F
