[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: <a href="/cdn-cgi/l/email-protection#244b545409404b474f41506441544549454d480a4154450a434b52"><span class="__cf_email__" data-cfemail="b5dac5c598d1dad6ded0c1f5d0c5d4d8d4dcd99bd0c5d49bd2dac3">[email protected]</span></a>. 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: 
<a href="/cdn-cgi/l/email-protection#88ffe9e4e4edfaa6e5e9faf1c8edf8e9e5e9e1e4a6edf8e9a6efe7fe"><span class="__cf_email__" data-cfemail="5324323f3f36217d3e32212a133623323e323a3f7d3623327d343c25">[email protected]</span></a>.

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 <ls-thn-eq>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 10-<SUP>3</SUP> mg/kg/day; for adult 
females, 1.3 x 10-<SUP>3</SUP> mg/kg/day; and for children, 4.0 x 10-
<SUP>3</SUP> 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 ft<SUP>2</SUP> is used in place of the high-end lawn 
default value of 20,000 ft<SUP>2</SUP>. 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 (Ni<SUP>63</SUP>) 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:
    <a href="/cdn-cgi/l/email-protection#cba4bbbbe6afa4a8a0aebf8baebbaaa6aaa2a7e5aebbaae5aca4bd"><span class="__cf_email__" data-cfemail="8ee1fefea3eae1ede5ebfaceebfeefe3efe7e2a0ebfeefa0e9e1f8">[email protected]</span></a>.


    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


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