[Federal Register Volume 63, Number 179 (Wednesday, September 16, 1998)]
[Rules and Regulations]
[Pages 49472-49479]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-24845]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-300705; FRL-6025-1]
RIN 2070-AB78


Myclobutanil; Pesticide Tolerances for Emergency Exemptions

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes time-limited tolerances for 
combined residues of myclobutanil in or on artichokes, asparagus, and 
peppers (bell and non-bell). This action is in response to EPA's 
granting of emergency exemptions under section 18 of the Federal 
Insecticide, Fungicide, and Rodenticide Act authorizing use of the 
pesticide on artichokes, asparagus, and peppers (bell and non-bell) in 
California (all three commodities), Michigan (asparagus) and New Mexico 
(peppers). This regulation establishes a maximum permissible level for 
residues of myclobutanil in these food commodities pursuant to section 
408(l)(6) of the Federal Food, Drug, and Cosmetic Act, as amended by 
the Food Quality Protection Act of 1996. These tolerances will expire 
and are revoked on July 31, 2000.

DATES: This regulation is effective September 16, 1998. Objections and 
requests for hearings must be received by EPA on or before November 16, 
1998.

ADDRESSES: Written objections and hearing requests, identified by the 
docket control number, [OPP-300705], must be submitted to: Hearing 
Clerk (1900), Environmental Protection Agency, Rm. M3708, 401 M St., 
SW., Washington, DC 20460. Fees accompanying objections and hearing 
requests shall be labeled ``Tolerance Petition Fees'' and forwarded to: 
EPA Headquarters Accounting Operations Branch, OPP (Tolerance Fees), 
P.O. Box 360277M, Pittsburgh, PA 15251. A copy of any objections and 
hearing requests filed with the Hearing Clerk identified by the docket 
control number, [OPP-300705], must also be submitted to: Public 
Information and Records Integrity Branch, Information Resources and 
Services Division (7502C), Office of Pesticide Programs, Environmental 
Protection Agency, 401 M St., SW., Washington, DC 20460. In person, 
bring a copy of objections and hearing requests to Rm. 119, CM #2, 1921 
Jefferson Davis Hwy., Arlington, VA.
    A copy of objections and hearing requests filed with the Hearing 
Clerk may also be submitted electronically by sending electronic mail 
(e-mail) to: [email protected]. Copies of objections and 
hearing requests must be submitted as an ASCII file avoiding the use of 
special characters and any form of encryption. Copies of objections and 
hearing requests will also be accepted on disks in WordPerfect 5.1/6.1 
file format or ASCII file format. All copies of objections and hearing 
requests in electronic form must be identified by the docket control 
number [OPP-300705]. No Confidential Business Information (CBI) should 
be submitted through e-mail. Electronic copies of objections and 
hearing requests on this rule may be filed online at many Federal 
Depository Libraries.

FOR FURTHER INFORMATION CONTACT: By mail: David Deegan, Registration 
Division (7505C), Office of Pesticide Programs, Environmental 
Protection Agency, 401 M St., SW., Washington, DC 20460. Office 
location, telephone number, and e-mail address: Crystal Mall #2, 1921 
Jefferson Davis Hwy., Arlington, VA, (703) 308-9358, e-mail: 
[email protected].

SUPPLEMENTARY INFORMATION: EPA, on its own initiative, pursuant to 
section 408(e) and (l)(6) of the Federal Food, Drug, and Cosmetic Act 
(FFDCA), 21 U.S.C. 346a(e) and (l)(6), is establishing tolerances for 
the combined residues of the fungicide myclobutanil, in or on 
artichokes at 1.0 parts per million (ppm), asparagus at 0.02 ppm, and 
on peppers (bell and non-bell) at 1.0 ppm. These tolerances will expire 
and are revoked on July 31, 2000. EPA will publish a document in the 
Federal Register to remove the revoked tolerances from the Code of 
Federal Regulations.

I. Background and Statutory Authority

    The Food Quality Protection Act of 1996 (FQPA) (Pub. L. 104-170) 
was signed into law August 3, 1996. FQPA amends both the Federal Food, 
Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 301 et seq., and the Federal 
Insecticide, Fungicide, and Rodenticide Act (FIFRA), 7 U.S.C. 136 et 
seq. The FQPA amendments went into effect immediately. Among other 
things, FQPA amends FFDCA to bring all EPA pesticide tolerance-setting 
activities under a new section 408 with a new safety standard and new 
procedures. These activities are described below and discussed in 
greater detail in the final rule establishing the time-limited 
tolerance associated with the emergency exemption for use of 
propiconazole on sorghum (61 FR 58135, November 13, 1996)(FRL-5572-9).
    New section 408(b)(2)(A)(i) of the FFDCA allows EPA to establish a 
tolerance (the legal limit for a pesticide chemical residue in or on a 
food) only if EPA determines that the tolerance is ``safe.'' Section 
408(b)(2)(A)(ii) defines ``safe'' to mean that ``there is a reasonable 
certainty that no harm will result from aggregate exposure to the 
pesticide chemical residue, including all anticipated dietary exposures 
and all other exposures for which there is reliable information.'' This 
includes exposure through drinking water and in residential settings, 
but does not include occupational exposure. Section 408(b)(2)(C) 
requires EPA to give special consideration to exposure of infants and 
children to the pesticide chemical residue in establishing a tolerance 
and to ``ensure that there is a reasonable certainty that no harm will 
result to infants and children from aggregate exposure to the pesticide 
chemical residue. . . .''
    Section 18 of FIFRA authorizes EPA to exempt any Federal or State 
agency from any provision of FIFRA, if EPA determines that ``emergency 
conditions exist which require such exemption.'' This provision was not 
amended by FQPA. EPA has established regulations governing such 
emergency exemptions in 40 CFR part 166.
    Section 408(l)(6) of the FFDCA requires EPA to establish a time-
limited tolerance or exemption from the requirement for a tolerance for 
pesticide chemical residues in food that will result from the use of a 
pesticide under an emergency exemption granted by EPA under section 18 
of FIFRA. Such tolerances can be established without providing notice 
or period for public comment.
    Because decisions on section 18-related tolerances must proceed 
before EPA reaches closure on several policy issues relating to 
interpretation and implementation of the FQPA, EPA does

[[Page 49473]]

not intend for its actions on such tolerance to set binding precedents 
for the application of section 408 and the new safety standard to other 
tolerances and exemptions.

II. Emergency Exemption for Use of Myclobutanil on Artichokes, 
Asparagus, and Peppers (Bell and Non-bell), and FFDCA Tolerances

    The state of California requested specific exemptions for the use 
of myclobutanil on artichokes to control powdery mildew, on asparagus 
to control asparagus rust, and bell and non-bell peppers to control 
powdery mildew. Michigan requested a specific exemption for use of 
myclobutanil on asparagus to control asparagus rust. New Mexico 
requested a specific exemption for the use of myclobutanil on bell and 
non-bell peppers to control powdery mildew.
    EPA has authorized under FIFRA section 18 the use of myclobutanil 
on artichoke to control powdery mildew in California, on asparagus to 
control asparagus rust in California and Michigan, and on peppers (bell 
and non-bell) for control of powdery mildew in California and New 
Mexico. After having reviewed these submissions, EPA concurs that 
emergency conditions exist for these states.
    As part of its assessment of this emergency exemption, EPA assessed 
the potential risks presented by residues of myclobutanil in or on 
artichoke, asparagus, and bell and non-bell peppers. In doing so, EPA 
considered the new safety standard in FFDCA section 408(b)(2), and EPA 
decided that the necessary tolerances under FFDCA section 408(l)(6) 
would be consistent with the new safety standard and with FIFRA section 
18. Consistent with the need to move quickly on the emergency exemption 
in order to address an urgent non-routine situation and to ensure that 
the resulting food is safe and lawful, EPA is issuing these tolerances 
without notice and opportunity for public comment under section 408(e), 
as provided in section 408(l)(6). Although these tolerances will expire 
and are revoked on July 31, 2000, under FFDCA section 408(l)(5), 
residues of the pesticide not in excess of the amounts specified in the 
tolerances remaining in or on artichoke, asparagus, and peppers (bell 
and non-bell) after that date will not be unlawful, provided the 
pesticide is applied in a manner that was lawful under FIFRA. EPA will 
take action to revoke these tolerances earlier if any experience with, 
scientific data on, or other relevant information on this pesticide 
indicate that the residues are not safe.
    Because these tolerances are being approved under emergency 
conditions, EPA has not made any decisions about whether myclobutanil 
meets EPA's registration requirements for use on artichoke, asparagus, 
or on bell and non-bell peppers or whether permanent tolerances for 
these uses would be appropriate. Under these circumstances, EPA does 
not believe that these tolerances serve as a basis for registration of 
myclobutanil by a State for special local needs under FIFRA section 
24(c). Nor do these tolerances serve as the basis for any States other 
than those already detailed within this document to use this pesticide 
on these crops under section 18 of FIFRA without following all 
provisions of section 18 as identified in 40 CFR part 166. For 
additional information regarding the emergency exemption for 
myclobutanil, contact the Agency's Registration Division at the address 
provided above.

III. Risk Assessment and Statutory Findings

    EPA performs a number of analyses to determine the risks from 
aggregate exposure to pesticide residues. First, EPA determines the 
toxicity of pesticides based primarily on toxicological studies using 
laboratory animals. These studies address many adverse health effects, 
including (but not limited to) reproductive effects, developmental 
toxicity, toxicity to the nervous system, and carcinogenicity. Second, 
EPA examines exposure to the pesticide through the diet (e.g., food and 
drinking water) and through exposures that occur as a result of 
pesticide use in residential settings.

A. Toxicity

    1. Threshold and non-threshold effects. For many animal studies, a 
dose response relationship can be determined, which provides a dose 
that causes adverse effects (threshold effects) and doses causing no 
observed effects (the ``no-observed effect level'' or ``NOEL'').
    Once a study has been evaluated and the observed effects have been 
determined to be threshold effects, EPA generally divides the NOEL from 
the study with the lowest NOEL by an uncertainty factor (usually 100 or 
more) to determine the Reference Dose (RfD). The RfD is a level at or 
below which daily aggregate exposure over a lifetime will not pose 
appreciable risks to human health. An uncertainty factor (sometimes 
called a ``safety factor'') of 100 is commonly used since it is assumed 
that people may be up to 10 times more sensitive to pesticides than the 
test animals, and that one person or subgroup of the population (such 
as infants and children) could be up to 10 times more sensitive to a 
pesticide than another. In addition, EPA assesses the potential risks 
to infants and children based on the weight of the evidence of the 
toxicology studies and determines whether an additional uncertainty 
factor is warranted. Thus, an aggregate daily exposure to a pesticide 
residue at or below the RfD (expressed as 100% or less of the RfD) is 
generally considered acceptable by EPA. EPA generally uses the RfD to 
evaluate the chronic risks posed by pesticide exposure. For shorter 
term risks, EPA calculates a margin of exposure (MOE) by dividing the 
estimated human exposure into the NOEL from the appropriate animal 
study. Commonly, EPA finds MOEs lower than 100 to be unacceptable. This 
100-fold MOE is based on the same rationale as the 100-fold uncertainty 
factor.
    Lifetime feeding studies in two species of laboratory animals are 
conducted to screen pesticides for cancer effects. When evidence of 
increased cancer is noted in these studies, the Agency conducts a 
weight of the evidence review of all relevant toxicological data 
including short-term and mutagenicity studies and structure activity 
relationship. Once a pesticide has been classified as a potential human 
carcinogen, different types of risk assessments (e.g., linear low dose 
extrapolations or MOE calculation based on the appropriate NOEL) will 
be carried out based on the nature of the carcinogenic response and the 
Agency's knowledge of its mode of action.
    2. Differences in toxic effect due to exposure duration. The 
toxicological effects of a pesticide can vary with different exposure 
durations. EPA considers the entire toxicity data base, and based on 
the effects seen for different durations and routes of exposure, 
determines which risk assessments should be done to assure that the 
public is adequately protected from any pesticide exposure scenario. 
Both short and long durations of exposure are always considered. 
Typically, risk assessments include ``acute,'' ``short-term,'' 
``intermediate term,'' and ``chronic'' risks. These assessments are 
defined by the Agency as follows.
    Acute risk, by the Agency's definition, results from 1-day 
consumption of food and water, and reflects toxicity which could be 
expressed following a single oral exposure to the pesticide residues. 
High end exposure to food and water residues are typically assumed.

[[Page 49474]]

    Short-term risk results from exposure to the pesticide for a period 
of 1-7 days, and therefore overlaps with the acute risk assessment. 
Historically, this risk assessment was intended to address primarily 
dermal and inhalation exposure which could result, for example, from 
residential pesticide applications. However, since enaction of FQPA, 
this assessment has been expanded to include both dietary and non-
dietary sources of exposure, and will typically consider exposure from 
food, water, and residential uses when reliable data are available. In 
this assessment, risks from average food and water exposure, and high-
end residential exposure, are aggregated. High-end exposures from all 3 
sources are not typically added because of the very low probability of 
this occurring in most cases, and because the other conservative 
assumptions built into the assessment assure adequate protection of 
public health. However, for cases in which high-end exposure can 
reasonably be expected from multiple sources (e.g. frequent and 
widespread homeowner use in a specific geographical area), multiple 
high-end risks will be aggregated and presented as part of the 
comprehensive risk assessment/characterization. Since the toxicological 
endpoint considered in this assessment reflects exposure over a period 
of at least 7 days, an additional degree of conservatism is built into 
the assessment; i.e., the risk assessment nominally covers 1-7 days 
exposure, and the toxicological endpoint/NOEL is selected to be 
adequate for at least 7 days of exposure. (Toxicity results at lower 
levels when the dosing duration is increased.)
    Intermediate-term risk results from exposure for 7 days to several 
months. This assessment is handled in a manner similar to the short-
term risk assessment.
    Chronic risk assessment describes risk which could result from 
several months to a lifetime of exposure. For this assessment, risks 
are aggregated considering average exposure from all sources for 
representative population subgroups including infants and children.

B. Aggregate Exposure

    In examining aggregate exposure, FFDCA section 408 requires that 
EPA take into account available and reliable information concerning 
exposure from the pesticide residue in the food in question, residues 
in other foods for which there are tolerances, residues in groundwater 
or surface water that is consumed as drinking water, and other non-
occupational exposures through pesticide use in gardens, lawns, or 
buildings (residential and other indoor uses). Dietary exposure to 
residues of a pesticide in a food commodity are estimated by 
multiplying the average daily consumption of the food forms of that 
commodity by the tolerance level or the anticipated pesticide residue 
level. The Theoretical Maximum Residue Contribution (TMRC) is an 
estimate of the level of residues consumed daily if each food item 
contained pesticide residues equal to the tolerance. In evaluating food 
exposures, EPA takes into account varying consumption patterns of major 
identifiable subgroups of consumers, including infants and children. 
The TMRC is a ``worst case'' estimate since it is based on the 
assumptions that food contains pesticide residues at the tolerance 
level and that 100% of the crop is treated by pesticides that have 
established tolerances. If the TMRC exceeds the RfD or poses a lifetime 
cancer risk that is greater than approximately one in a million, EPA 
attempts to derive a more accurate exposure estimate for the pesticide 
by evaluating additional types of information (anticipated residue data 
and/or percent of crop treated data) which show, generally, that 
pesticide residues in most foods when they are eaten are well below 
established tolerances.
    Percent of crop treated estimates are derived from federal and 
private market survey data. Typically, a range of estimates are 
supplied and the upper end of this range is assumed for the exposure 
assessment. By using this upper end estimate of percent of crop 
treated, the Agency is reasonably certain that exposure is not 
understated for any significant subpopulation group. Further, regional 
consumption information is taken into account through EPA's computer-
based model for evaluating the exposure of significant subpopulations 
including several regional groups, to pesticide residues. For this 
pesticide, the most highly exposed population subgroup (non-nursing 
infants <1 year old) was not regionally based.

IV. Aggregate Risk Assessment and Determination of Safety

    Consistent with section 408(b)(2)(D), EPA has reviewed the 
available scientific data and other relevant information in support of 
this action, EPA has sufficient data to assess the hazards of 
myclobutanil and to make a determination on aggregate exposure, 
consistent with section 408(b)(2), for time-limited tolerances for the 
combined residues of myclobutanil on artichokes at 1.0 ppm, asparagus 
at 0.02 ppm, and peppers (bell and non-bell) at 1.0 ppm. EPA's 
assessment of the dietary exposures and risks associated with 
establishing the tolerance follows.

A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered its 
validity, completeness, and reliability as well as the relationship of 
the results of the studies to human risk. EPA has also considered 
available information concerning the variability of the sensitivities 
of major identifiable subgroups of consumers, including infants and 
children. The nature of the toxic effects caused by myclobutanil are 
discussed below.
    1. Acute toxicity. None. For acute dietary risk, EPA has not 
identified an acute dietary endpoint.
     2. Short - and intermediate - term toxicity. For short-term dermal 
Margin of Exposure (MOE) calculations, the Agency used the systemic 
NOEL of 100 mg/kg/day from a 21-day dermal toxicity study in rats. This 
dose was the highest tested in the study. The Agency did not identify 
an inhalation endpoint.
    For intermediate-term MOE calculations, the Agency used the NOEL of 
10 miligrams/kilograms/day (mg/kg/day) from a 2-generation reproductive 
toxicity study in rats. At the Lowest Effect Level (LEL) of 50 mg/kg/
day, there were decreases in pup body weight, an increased incidence in 
the number of stillborns, and atrophy of the prostate and testes.
    3. Chronic toxicity. EPA has established the RfD for myclobutanil 
at 0.025 mg/kg/day. This RfD is based on a chronic feeding study in 
rats using a NOEL of 2.5 mg/kg/day and an uncertainty factor of 100. At 
the Lowest Observed Effect Level (LOEL) of 9.9 mg/kg/day there was 
testicular atrophy.
    4. Carcinogenicity. Myclobutanil has been classified as a Group E 
chemical (no evidence of carcinogenicity for humans) by the Agency.

B. Exposures and Risks

    1. From food and feed uses. Tolerances have been established (40 
CFR 180.443) for the combined residues of myclobutanil alpha-butyl-
alpha-(4-chlorophenyl)-1H-1,2,4-triazole-1-propanenitrile plus its 
alcohol metabolite alpha-(3-hydroxybutyl)-alpha-(4-chlorophenyl)-1H-
1,2,4-triazole-1-propanenitrile (free and bound), in or on a variety of 
raw agricultural commodities at levels ranging from 25.0 ppm in raisin 
waste to 0.02 ppm in cottonseed. Tolerances have also been established 
(40 CFR 180.443(b)) for the combined residues of myclobutanil plus its 
alcohol metabolite

[[Page 49475]]

(free and bound) and diol metabolite alpha-(4-chlorophenyl)-alpha-(3,4-
dihydroxybutyl)-1H-1,2,4-triazole-1-propanenitrile, in meat, milk, 
poultry and eggs, at levels ranging from 0.02 ppm to 1.0 ppm. Risk 
assessments were conducted by EPA to assess dietary exposures and risks 
from myclobutanil as follows:
    i.  Acute exposure and risk. Acute dietary risk assessments are 
performed for a food-use pesticide if a toxicological study has 
indicated the possibility of an effect of concern occurring as a result 
of a one day or single exposure.
    ii. Chronic exposure and risk. In conducting this chronic dietary 
risk assessment, EPA has made somewhat conservative assumptions -- with 
the exception of bananas, all commodities having myclobutanil 
tolerances will contain myclobutanil and metabolite residues and those 
residues will be at the level of the established tolerance -- which 
results in an overestimate of human dietary exposure. For bananas an 
anticipated residue estimate was used. Percent crop-treated estimates 
were utilized for selected commodities included in the assessment. 
Thus, in making a safety determination for this tolerance, EPA is 
taking into account this partially refined exposure assessment.
    The existing myclobutanil tolerances (published, pending, and 
including the necessary section 18 tolerances) result in an Anticipated 
Residue Contribution (ARC) that is equivalent to the following 
percentages of the RfD:


                                                                        
------------------------------------------------------------------------
                                    ARCfood (mg/kg/                     
       Population Subgroup               day)                %Rfd       
------------------------------------------------------------------------
U.S. Population (48 states)       0.004283            17%               
Nursing Infants (<1 year old)     0.006365            25%               
Non-Nursing Infants (<1 year      0.018836            75%               
 old)                                                                   
Children (1-6 years old)          0.011508            46%               
Children (7-12 years old)         0.006924            28%               
Northeast Region                  0.004573            18%               
Western Region                    0.004880            19%               
Hispanics                         0.005066            20%               
Non-Hispanic Others               0.004443            18%               
------------------------------------------------------------------------


    The subgroups listed above are: (1) the U.S. population (48 
states); (2) those for infants and children; and, (3) the other 
subgroups for which the percentage of the Rfd occupied is greater than 
that occupied by the subgroup U.S. population (48 states).
    2. From drinking water. Chronic exposure and risk Based on 
information available to EPA, myclobutanil is persistent and not 
considered mobile in soils with the exception of sandy soils. Data are 
not available for its metabolite alpha-(3-hydroxybutyl)-alpha-(4-
chlorophenyl)-1H-1,2,4-triazole-1-propanenitrile. There is no 
established Maximum Contaminant Level for residues of myclobutanil in 
drinking water. No Health Advisory Levels for myclobutanil in drinking 
water have been established. The ``Pesticides in Groundwater Database'' 
(EPA 734-12-92-001, September 1992) has no information concerning 
myclobutanil.
    EPA has estimated ground and surface water concentrations for 
myclobutanil based on the label rate of 0.65 lbs active ingredient 
(a.i.)/acre and assuming 15 applications per season. (The water numbers 
were based on turf.) The surface water numbers are based on the results 
of GENEEC model run. The ground water numbers are based on a screening 
tool, SCI-GROW, which tends to overestimate the true concentrations in 
the environment.
    Surface water EEC based on the results of a GENEEC model run
    Acute = 145.96 ppb (0.14596 ppm or mg/L)(maximum initial 
concentration)
    Chronic = 118.6 ppb (0.1186 ppm or mg/L)(average 56-day 
concentration)
    EPA divides the 90/56-day GENEEC value by 3 to obtain a value for 
chronic risk assessment calculations. Therefore, the surface water 
value for use in the chronic risk assessment would be 0.04 ppm or mg/L.
    Ground water EEC (SCI-GROW estimate)
    3.6 ppb (0.0036 ppm or mg/L) (use for both acute and chronic)
    Chronic exposure from surface water is calculated below. Chronic 
exposure from ground water is lower.
    EPA has calculated drinking water levels of concern (DWLOCs) for 
chronic (non-cancer) exposure to be 0.7 ppm for U.S. population, 0.6 
ppm for Hispanics, and 0.06 ppm for non-nursing infants (<1 year old ). 
To calculate the DWLOC for chronic (non-cancer) exposure relative to a 
chronic toxicity endpoint, the chronic dietary food exposure (from 
DRES) was subtracted from the RfD to obtain the acceptable chronic 
(non-cancer) exposure to myclobutanil in drinking water.
    The estimated average concentration of myclobutanil in surface 
water is 0.04 ppm. Chronic concentrations in ground water are not 
expected to be higher than the acute concentrations. The estimated 
average concentrations of myclobutanil in surface water are less than 
EPA's levels of concern for myclobutanil in drinking water as a 
contribution to chronic aggregate exposure. Therefore, taking into 
account the present uses and uses proposed in this action, EPA 
concludes with reasonable certainty that residues of myclobutanil in 
drinking water (when considered along with other sources of exposure 
for which EPA has reliable data) would not result in unacceptable 
levels of aggregate human health risk at this time.
    EPA bases this determination on a comparison of estimated 
concentrations of myclobutanil in surface waters and ground waters to 
back-calculated ``levels of concern'' for myclobutanil in drinking 
water. These levels of concern in drinking water were determined after 
EPA has considered all other non-occupational human exposures for which 
it has reliable data, including all current uses, and uses considered 
in this action. The estimates of myclobutanil in surface waters are 
derived from water quality models that use conservative assumptions 
(health-protective) regarding the pesticide transport from the point of 
application to surface and ground water. Because EPA considers the 
aggregate risk resulting from multiple exposure pathways associated 
with a pesticide's uses, levels of concern in drinking water may vary 
as those uses change. If new uses are added in the future, EPA will 
reassess the potential impacts of myclobutanil on drinking water as a 
part of the aggregate risk assessment process.
    3. From non-dietary exposure. Myclobutanil is currently registered 
for outdoor residential and greenhouse use on annuals and perennials, 
turf, shrubs, trees, and flowers. EPA has determined that these uses do 
not constitute a chronic exposure scenario, but may constitute a short- 
to intermediate-term exposure scenario (Note: the intermediate-term 
potential exposure would come from Post-application (dermal for adult; 
and dermal + ingestion of soil only, due to the persistence of the 
pesticide in soil, for toddlers). Other intermediate-term exposure 
scenarios are unlikely as dissipation is strongly influenced by the 
growth of the grass which needs weekly mowing (more frequently in 
spring) and most dissipation studies on lawns show considerable tailing 
off of residues by day 3 or 4; thus, the expectation of significant 
residues is very unlikely.
    4. Homeowner-use Products. End-use products containing the active 
ingredient, myclobutanil, are marketed for homeowner use. The homeowner 
use with the greatest potential for exposure takes the form of small 
scale lawn application (other additional

[[Page 49476]]

application uses are on roses, flowers, ornamental shrubs and trees) of 
a soluble concentrate with a hose-end, backpack, or trigger bottle 
sprayer. Application of these products is recommended at two week 
intervals. Short-term (and not intermediate-term exposures, because of 
the amount of time it takes to mix, load, and apply this product) 
exposure is considered only. Short-term exposure, pre- and during 
application, will be considered an aggregate potential exposure: a 
summation of this exposure will include exposure levels for: the mixer 
+ loader + applicator + Post-application on day zero (day of 
application). Short- and intermediate-term exposure will be considered 
during post-application (Note: Intermediate-term exposure is addressed 
only during post-application scenarios).
    5. Cumulative exposure to substances with common mechanism of 
toxicity. Section 408(b)(2)(D)(v) requires that, when considering 
whether to establish, modify, or revoke a tolerance, the Agency 
consider ``available information'' concerning the cumulative effects of 
a particular pesticide's residues and ``other substances that have a 
common mechanism of toxicity.'' The Agency believes that ``available 
information'' in this context might include not only toxicity, 
chemistry, and exposure data, but also scientific policies and 
methodologies for understanding common mechanisms of toxicity and 
conducting cumulative risk assessments. For most pesticides, although 
the Agency has some information in its files that may turn out to be 
helpful in eventually determining whether a pesticide shares a common 
mechanism of toxicity with any other substances, EPA does not at this 
time have the methodologies to resolve the complex scientific issues 
concerning common mechanism of toxicity in a meaningful way. EPA has 
begun a pilot process to study this issue further through the 
examination of particular classes of pesticides. The Agency hopes that 
the results of this pilot process will increase the Agency's scientific 
understanding of this question such that EPA will be able to develop 
and apply scientific principles for better determining which chemicals 
have a common mechanism of toxicity and evaluating the cumulative 
effects of such chemicals. The Agency anticipates, however, that even 
as its understanding of the science of common mechanisms increases, 
decisions on specific classes of chemicals will be heavily dependent on 
chemical specific data, much of which may not be presently available.
    Although at present the Agency does not know how to apply the 
information in its files concerning common mechanism issues to most 
risk assessments, there are pesticides as to which the common mechanism 
issues can be resolved. These pesticides include pesticides that are 
toxicologically dissimilar to existing chemical substances (in which 
case the Agency can conclude that it is unlikely that a pesticide 
shares a common mechanism of activity with other substances) and 
pesticides that produce a common toxic metabolite (in which case common 
mechanism of activity will be assumed).
    EPA does not have, at this time, available data to determine 
whether myclobutanil has a common mechanism of toxicity with other 
substances or how to include this pesticide in a cumulative risk 
assessment. Unlike other pesticides for which EPA has followed a 
cumulative risk approach based on a common mechanism of toxicity, 
myclobutanil does not appear to produce a toxic metabolite produced by 
other substances. For the purposes of this tolerance action, therefore, 
EPA has not assumed that myclobutanil has a common mechanism of 
toxicity with other substances.

C. Aggregate Risks and Determination of Safety for U.S. Population

    1. Chronic aggregate exposure and risk. Using the partially refined 
exposure assumptions described above, EPA has concluded that aggregate 
exposure (food, water, and residential) to myclobutanil will not exceed 
EPA's level of concern. For the U.S. population, 17% of the RfD is 
occupied by dietary (food) exposure. The estimated average 
concentrations of myclobutanil in surface and ground water are less 
than EPA's levels of concern for myclobutanil in drinking water as a 
contribution to chronic aggregate exposure. Therefore, EPA concludes 
with reasonable certainty that residues of myclobutanil in drinking 
water do not contribute significantly to the aggregate chronic human 
health risk at the present time considering the present uses and uses 
proposed in this action. EPA has determined that the outdoor registered 
uses of myclobutanil would not fall under a chronic exposure scenario. 
EPA concludes that there is a reasonable certainty that no harm will 
result from aggregate chronic exposure to myclobutanil residues.
    2. Short- and intermediate-term risk. The short-term NOEL for 
dermal exposure is based on a dermal exposure toxicity study. Since the 
NOEL is based on a dermal study, oral exposures generally cannot be 
used directly to calculate a short-term aggregate exposure. However, 
because EPA determined that a dermal absorption factor of 100% should 
be used for risk assessment, oral exposures need not be multiplied by a 
modifying factor (converted to dermal equivalents) so that they can be 
compared to the dermal endpoint.
    The chronic dietary exposure and calculated dietary MOE for the 
U.S. Population is as follows: MOE= 23,000, based on ARC of 0.004283 
mg/kg/day.
    The intermediate-term exposure scenarios and calculated MOE for the 
U.S.Population is as follows: MOE= 2,300, based on ARC of 0.004283 mg/
kg/day.
    There is a potential for short-term exposure from drinking water. 
However, as estimated average concentrations of myclobutanil in surface 
and ground water are less than EPA's levels of concern for drinking 
water as a contribution to chronic aggregate and acute aggregate 
exposures, contribution to short-term exposure should not exceed EPA's 
levels of concern either.
    EPA concludes that short-term aggregate MOEs for adults are 
acceptable considering the default assumptions used in the derivation 
of exposure estimates and the fact that a LOEL was not identified in 
the 28-day rat dermal toxicity study the highest dose tested (HDT) was 
the NOEL in this study used to determine the MOE. Chemical-specific 
dissipation data and residential use/usage information are required to 
further refine these post-application exposure estimates.

D. Aggregate Cancer Risk for U.S. Population

    Myclobutanil was classified by the Agency as a Group E chemical (no 
evidence of carcinogenicity for humans). Thus, a cancer risk assessment 
was not conducted.

E. Endocrine Disruptor Effects

    EPA is required to develop a screening program to determine whether 
certain substances (including all pesticides and inerts) ``may have an 
effect in humans that is similar to an effect produced by a naturally 
occurring estrogen, or such other endocrine effect....'' The Agency is 
currently working with interested stakeholders, including other 
government agencies, public interest groups, industry and research 
scientists in developing a screening and testing program and a priority 
setting scheme to implement this program. Congress has allowed 3 years 
from the passage of FQPA (August 3, 1999) to implement this program. At

[[Page 49477]]

that time, EPA may require further testing of this active ingredient 
and end use products for endocrine disrupter effects.
    Based on the adverse testicular findings, and increase in the 
number of stillborns, and a decrease in pup weight gain during 
lactation, in the chronic toxicity and reproduction studies in rats, 
myclobutanil should be considered as a candidate for evaluation as an 
endocrine disruptor.

F. Aggregate Risks and Determination of Safety for Infants and Children

    1. Safety factor for infants and children --i. In general. In 
assessing the potential for additional sensitivity of infants and 
children to residues of myclobutanil, EPA considered data from 
developmental toxicity studies in the rat and rabbit and a two-
generation reproduction study in the rat. The developmental toxicity 
studies are designed to evaluate adverse effects on the developing 
organism resulting from pesticide exposure during prenatal development 
to one or both parents. Reproduction studies provide information 
relating to effects from exposure to the pesticide on the reproductive 
capability of mating animals and data on systemic toxicity.
    FFDCA section 408 provides that EPA shall apply an additional 
tenfold margin of safety for infants and children in the case of 
threshold effects to account for pre-and post-natal toxicity and the 
completeness of the database unless EPA determines that a different 
margin of safety will be safe for infants and children. Margins of 
safety are incorporated into EPA risk assessments either directly 
through use of a MOE analysis or through using uncertainty (safety) 
factors in calculating a dose level that poses no appreciable risk to 
humans. EPA believes that reliable data support using the standard MOE 
and uncertainty factor (usually 100 for combined inter- and intra-
species variability)) and not the additional tenfold MOE/uncertainty 
factor when EPA has a complete data base under existing guidelines and 
when the severity of the effect in infants or children or the potency 
or unusual toxic properties of a compound do not raise concerns 
regarding the adequacy of the standard MOE/safety factor.
    ii. Developmental toxicity studies. In the developmental study in 
rats, the maternal (systemic) NOEL was 93.8 mg/kg/day, based on rough 
hair coat, and salivation at the LOEL of 312.6 mg/kg/day. The 
developmental (fetal) NOEL was 93.8 mg/kg/day based on incidences of 
14th rudimentary and 7th cervical ribs at the LOEL of 312.6 mg/kg/day.
    In the developmental toxicity study in rabbits, the maternal 
(systemic) NOEL was 60 mg/kg/day, based on reduced weight gain, 
clinical signs of toxicity and abortions at the LOEL of 200 mg/kg/day. 
The developmental (fetal) NOEL was 60 mg/kg/day, based on increases in 
number of resorptions, decreases in litter size, and a decrease in the 
viability index at the LOEL of 200 mg/kg/day.
    iii. Reproductive toxicity study. In the 2-generation reproductive 
toxicity study in rats, the parental (systemic) NOEL was 2.5 mg/kg/day, 
based on increased liver weights and liver cell hypertrophy at the LOEL 
of 10 mg/kg/day. The developmental (pup) NOEL was 10 mg/kg/day, based 
on decreased pup body weight during lactation at the LOEL of 50 mg/kg/
day. The reproductive (pup) NOEL was 10 mg/kg/day, based on the 
increased incidence of stillborns, and atrophy of the testes, 
epididymides, and prostate at the LEL of 50 mg/kg/day.
    iv. Pre- and post-natal sensitivity. The pre- and post-natal 
toxicology data base for myclobutanil is complete with respect to 
current toxicological data requirements. Based on the developmental and 
reproductive toxicity studies discussed above, for myclobutanil there 
does not appear to be an extra sensitivity for pre- or post-natal 
effects.
    v. Conclusion. Based on the above, EPA concludes that reliable data 
support use of the standard 100-fold uncertainty factor and that an 
factor is not needed to protect the safety of infants and children.
    2. Chronic risk. Using the partially-refined exposure assumptions 
described above, EPA has concluded that aggregate exposure to 
myclobutanil from food ranges from 25% of the RfD for nursing infants 
(<1 year old), up to 75% for non-nursing infants (<1 year old). EPA 
generally has no concern for exposures below 100% of the RfD because 
the RfD represents the level at or below which daily aggregate dietary 
exposure over a lifetime will not pose appreciable risks to human 
health. Despite the potential for exposure to myclobutanil in drinking 
water and from non-dietary, non-occupational exposure, EPA does not 
expect the aggregate exposure to exceed 100% of the RfD. EPA concludes 
that there is a reasonable certainty that no harm will result to 
infants and children from aggregate exposure to myclobutanil residues.
    3. Short- or intermediate-term risk. The short-term NOEL for dermal 
exposure is based on a dermal exposure toxicity study. Since the NOEL 
is based on a dermal study, oral exposures generally cannot be used 
directly to calculate a short-term aggregate exposure. However, because 
EPA determined that a dermal absorption factor of 100% should be used 
for risk assessment, oral exposures need not be multiplied by a 
modifying factor (converted to dermal equivalents) so that they can be 
compared to the dermal endpoint.
    The chronic dietary exposure and calculated dietary MOE for infants 
(non-nursing, < 1 year old) is 5,300, based on ARC of 0.018836 mg/kg/
day.
    The dermal residential exposure is 0.85 mg/kg/day (reentry). The 
calculated dietary MOE for non-nursing infants (<1 year old) is 5,300.
    For the short-term aggregate risk of the most highly exposed 
subgroup (non-nursing infants (<1 year old)), the calculated MOE is 
120. There is a potential for short-term exposure from drinking water. 
However, as estimated average concentrations of myclobutanil in surface 
and ground water are less than EPA's levels of concern for drinking 
water as a contribution to chronic aggregate and acute aggregate 
exposures, contribution to short-term exposure should not exceed EPA's 
levels of concern either. EPA concludes that short-term aggregate MOEs 
for non-nursing infants (<1 year old) are acceptable.

V. Other Considerations

A. Metabolism In Plants and Animals

    The nature of the residue in plants is adequately understood. The 
residue of concern is myclobutanil plus its alcohol metabolite (free 
and bound), as specified in 40 CFR 180.443(a).

B. Analytical Enforcement Methodology

    An adequate enforcement method is available to enforce the 
established tolerances. Quantitation is by Gas Liquid Chromatography 
(GLC) using an Nitrogen/Phosphorus detector for myclobu-tanil and an 
Electron Capture detector (Ni63) for residues measured as 
the alcohol metabolite.

C. Magnitude of Residues

    Residues of myclobutanil and its alcohol metabolite are not 
expected to exceed 1.0 ppm in/on artichoke, 0.02 ppm in/on asparagus, 
and 1.0 ppm in/on peppers (bell and non-bell), as a result of these 
section 18 uses. Secondary residues are not expected in animal 
commodities as no feedstuffs are associated with these section 18 uses. 
Meat/ milk/poultry/ egg tolerances have been established as a result of 
other myclobutanil uses.

[[Page 49478]]

D. International Residue Limits

    There are no Codex, Canadian or Mexican residue limits established 
for myclobutanil and its metabolites on the commodities included in 
these section 18 requests. Thus, harmonization is not an issue for 
these section 18 actions.

E. Rotational Crop Restrictions.

    Information concerning the likelihood of residues in rotational 
crops is not currently available for myclobutanil, although such data 
is expected to be submitted to EPA shortly. Until EPA has reviewed and 
approved such data, the Agency has required that the following 
restriction should be added to the label for approved section 18 uses: 
Rally treated fields can be rotated at any time to crops which are 
included on the Rally label. For crops not listed on the registered 
label, do not plant new crops on treated fields for these periods: 
leafy vegetables, small grains -- 120 days root vegetables, all other 
crops -- 210 days.

VI. Conclusion

    Therefore, the tolerance is established for combined residues of 
myclobutanil in artichoke at 1.0 ppm, asparagus at 0.02 ppm, and bell 
and non-bell peppers at 1.0 ppm.

VII. Objections and Hearing Requests

    The new FFDCA section 408(g) provides essentially the same process 
for persons to ``object'' to a tolerance regulation issued by EPA under 
new section 408(e) and (l)(6) as was provided in the old section 408 
and in section 409. However, the period for filing objections is 60 
days, rather than 30 days. EPA currently has procedural regulations 
which govern the submission of objections and hearing requests. These 
regulations will require some modification to reflect the new law. 
However, until those modifications can be made, EPA will continue to 
use those procedural regulations with appropriate adjustments to 
reflect the new law.
    Any person may, by November 16, 1998, file written objections to 
any aspect of this regulation and may also request a hearing on those 
objections. Objections and hearing requests must be filed with the 
Hearing Clerk, at the address given above (40 CFR 178.20). A copy of 
the objections and/or hearing requests filed with the Hearing Clerk 
should be submitted to the OPP docket for this rulemaking. The 
objections submitted must specify the provisions of the regulation 
deemed objectionable and the grounds for the objections (40 CFR 
178.25). Each objection must be accompanied by the fee prescribed by 40 
CFR 180.33(i). If a hearing is requested, the objections must include a 
statement of the factual issues on which a hearing is requested, the 
requestor's contentions on such issues, and a summary of any evidence 
relied upon by the requestor (40 CFR 178.27). A request for a hearing 
will be granted if the Administrator determines that the material 
submitted shows the following: There is genuine and substantial issue 
of fact; there is a reasonable possibility that available evidence 
identified by the requestor would, if established, resolve one or more 
of such issues in favor of the requestor, taking into account 
uncontested claims or facts to the contrary; and resolution of the 
factual issues in the manner sought by the requestor would be adequate 
to justify the action requested (40 CFR 178.32). Information submitted 
in connection with an objection or hearing request may be claimed 
confidential by marking any part or all of that information as 
Confidential Business Information (CBI). Information so marked will not 
be disclosed except in accordance with procedures set forth in 40 CFR 
part 2. A copy of the information that does not contain CBI must be 
submitted for inclusion in the public record. Information not marked 
confidential may be disclosed publicly by EPA without prior notice.

VIII. Public Record and Electronic Submissions

    EPA has established a record for this rulemaking under docket 
control number [OPP-300705] (including any comments and data submitted 
electronically). A public version of this record, including printed, 
paper versions of electronic comments, which does not include any 
information claimed as CBI, is available for inspection from 8:30 a.m. 
to 4 p.m., Monday through Friday, excluding legal holidays. The public 
record is located in Rm. 119 of the Public Information and Records 
Integrity Branch, Information Resources and Services Division (7502C), 
Office of Pesticide Programs, Environmental Protection Agency, Crystal 
Mall #2, 1921 Jefferson Davis Highway, Arlington, VA.
    Electronic comments may be sent directly to EPA at:
    [email protected].


    Electronic comments must be submitted as an ASCII file avoiding the 
use of special characters and any form of encryption.
    The official record for this rulemaking, as well as the public 
version, as described above will be kept in paper form. Accordingly, 
EPA will transfer any copies of objections and hearing requests 
received electronically into printed, paper form as they are received 
and will place the paper copies in the official rulemaking record which 
will also include all comments submitted directly in writing. The 
official rulemaking record is the paper record maintained at the 
Virginia address in ``ADDRESSES'' at the beginning of this document.

IX. Regulatory Assessment Requirements

A. Certain Acts and Executive Orders

    This final rule establishes tolerances under FFDCA section 408(d) 
in response to a petition submitted to the Agency. The Office of 
Management and Budget (OMB) has exempted these types of actions from 
review under Executive Order 12866, entitled Regulatory Planning and 
Review (58 FR 51735, October 4, 1993). This final rule does not contain 
any information collections subject to OMB approval under the Paperwork 
Reduction Act (PRA), 44 U.S.C. 3501 et seq., or impose any enforceable 
duty or contain any unfunded mandate as described under Title II of the 
Unfunded Mandates Reform Act of 1995 (UMRA) (Pub. L. 104-4). Nor does 
it require any prior consultation as specified by Executive Order 
12875, entitled Enhancing the Intergovernmental Partnership (58 FR 
58093, October 28, 1993), or special considerations as required by 
Executive Order 12898, entitled Federal Actions to Address 
Environmental Justice in Minority Populations and Low-Income 
Populations (59 FR 7629, February 16, 1994), or require OMB review in 
accordance with Executive Order 13045, entitled Protection of Children 
from Environmental Health Risks and Safety Risks (62 FR 19885, April 
23, 1997).

B. Executive Order 12875

    Under Executive Order 12875, entitled Enhancing Intergovernmental 
Partnerships (58 FR 58093, October 28, 1993), EPA may not issue a 
regulation that is not required by statute and that creates a mandate 
upon a State, local or tribal government, unless the Federal government 
provides the funds necessary to pay the direct compliance costs 
incurred by those governments. If the mandate is unfunded, EPA must 
provide to the Office of Management and Budget (OMB) a description of 
the extent of EPA's prior consultation with representatives of affected 
State, local and tribal governments, the nature of their concerns, 
copies of any written communications from the governments, and a 
statement supporting the need to issue the regulation. In addition,

[[Page 49479]]

Executive Order 12875 requires EPA to develop an effective process 
permitting elected officials and other representatives of State, local 
and tribal governments ``to provide meaningful and timely input in the 
development of regulatory proposals containing significant unfunded 
mandates.''
    Today's rule does not create an unfunded federal mandate on State, 
local or tribal governments. The rule does not impose any enforceable 
duties on these entities. Accordingly, the requirements of section 1(a) 
of Executive Order 12875 do not apply to this rule.

C. Executive Order 13084

    Under Executive Order 13084, entitled Consultation and Coordination 
with Indian Tribal Governments (63 FR 27655, May 19,1998), EPA may not 
issue a regulation that is not required by statute, that significantly 
or uniquely affects the communities of Indian tribal governments, and 
that imposes substantial direct compliance costs on those communities, 
unless the Federal government provides the funds necessary to pay the 
direct compliance costs incurred by the tribal governments. If the 
mandate is unfunded, EPA must provide OMB, in a separately identified 
section of the preamble to the rule, a description of the extent of 
EPA's prior consultation with representatives of affected tribal 
governments, a summary of the nature of their concerns, and a statement 
supporting the need to issue the regulation. In addition, Executive 
Order 13084 requires EPA to develop an effective process permitting 
elected and other representatives of Indian tribal governments ``to 
provide meaningful and timely input in the development of regulatory 
policies on matters that significantly or uniquely affect their 
communities.''
    Today's rule does not significantly or uniquely affect the 
communities of Indian tribal governments. This action does not involve 
or impose any requirements that affect Indian Tribes. Accordingly, the 
requirements of section 3(b) of Executive Order 13084 do not apply to 
this rule.
    In addition, since these tolerances and exemptions that are 
established on the basis of a petition under FFDCA section 408 (d), 
such as the tolerances in this final rule, do not require the issuance 
of a proposed rule, the requirements of the Regulatory Flexibility Act 
(RFA) (5 U.S.C. 601 et seq.) do not apply. Nevertheless, the Agency has 
previously assessed whether establishing tolerances, exemptions from 
tolerances, raising tolerance levels or expanding exemptions might 
adversely impact small entities and concluded, as a generic matter, 
that there is no adverse economic impact. The factual basis for the 
Agency's generic certification for tolerance actions published on May 
4, 1981 (46 FR 24950), and was provided to the Chief Counsel for 
Advocacy of the Small Business Administration.

X. Submission to Congress and the Comptroller General

    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the 
Small Business Regulatory Enforcement Fairness Act of 1996, generally 
provides that before a rule may take effect, the agency promulgating 
the rule must submit a rule report, which includes a copy of the rule, 
to each House of the Congress and to the Comptroller General of the 
United States. EPA will submit a report containing this rule and other 
required information to the U.S. Senate, the U.S. House of 
Representatives, and the Comptroller General of the United States prior 
to publication of the rule in the Federal Register. This rule is not a 
``major rule'' as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

    Environmental protection, Administrative practice and procedure, 
Agricultural commodities, Pesticides and pests, Reporting and 
recordkeeping requirements.

    Dated: August 26, 1998.

James Jones,
Director, Registration Division, Office of Pesticide Programs.

    Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

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

    Authority : 21 U.S.C. 346a and 371.

    2. In section 180.443, by adding new entries for artichokes, 
asparagus, and peppers (bell and non-bell) in alphabetical order to the 
table in paragraph (b), to read as follows:

Sec. 180.443  Myclobutanil; tolerances for residues.

* * * * *

    (b) * * *

                                                                        
------------------------------------------------------------------------
                                                          Expiration/   
            Commodity              Parts per million    Revocation Date 
------------------------------------------------------------------------
Artichoke.......................  1.0                 7/31/00           
Asparagus.......................  0.02                7/31/00           
                              *                *                        
                                        *                               
Peppers (bell and non-bell).....  1.0                 7/31/00           
                              *                *                        
                                        *                               
------------------------------------------------------------------------

* * * * *

[FR Doc. 98-24845 Filed 9-15-98; 8:45 am]
BILLING CODE 6560-50-F