[Federal Register Volume 62, Number 153 (Friday, August 8, 1997)]
[Rules and Regulations]
[Pages 42684-42690]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-20846]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-300522 FRL-5732-9]
RIN 2070-AB78


Myclobutanil; Pesticide Tolerances for Emergency Exemptions

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes time-limited tolerances for 
combined residues of myclobutanil in or on tomatoes . This action is in 
response to EPA's granting of an emergency exemption under section 18 
of the Federal Insecticide, Fungicide, and Rodenticide Act authorizing 
use of the pesticide on tomatoes. This regulation establishes a maximum 
permissible level for residues of myclobutanil in this food commodity 
pursuant to section 408(l)(6) of the Federal Food, Drug, and Cosmetic 
Act, as amended by the Food Quality Protection Act of 1996. The 
tolerance will expire and is revoked on July 28, 1998.

DATES: This regulation is effective August 8, 1997. Objections and 
requests for hearings must be received by EPA on or before October 7, 
1997.

ADDRESSES: Written objections and hearing requests, identified by the 
docket control number, [OPP-300522], 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-300522], must also be submitted to: Public 
Information and Records Integrity Branch, Information Resources and 
Services Division (7506C), 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. 1132, 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 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-300522]. 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: Andrew Ertman, 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) 308-9367, e-mail: 
[email protected].


[[Page 42685]]


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 
combined residues of the fungicide myclobutanil, in or on tomato fruit 
at 0.3 part per million (ppm), tomato puree at 0.6 ppm and tomato paste 
at 1.2 ppm. These tolerances will expire and are revoked on July 28, 
1998. 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 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 Myclobutanil on Tomatoes and FFDCA 
Tolerances

    The state of California requested a specific exemption for the use 
of myclobutanil on tomatoes to control powdery mildew (Leveillula 
taurica). Powdery mildew is a pathogen that was first identified as a 
problem on tomatoes in California in 1978. The applicant states that 
powdery mildew is endemic and well established throughout California 
and without the use of myclobutanil growers could incur severe economic 
damage to their crops. EPA has authorized under FIFRA section 18 the 
use of myclobutanil on tomatoes for control of powdery mildew in 
California. After having reviewed the submission, EPA concurs that 
emergency conditions exist for this state.
    As part of its assessment of this emergency exemption, EPA assessed 
the potential risks presented by residues of myclobutanil in or on 
tomatoes. In doing so, EPA considered the new safety standard in FFDCA 
section 408(b)(2), and EPA decided that the necessary tolerance under 
FFDCA section 408(l)(6) would be consistent with the 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 this tolerance without notice and opportunity 
for public comment under section 408(e), as provided in section 
408(l)(6). Although this tolerance will expire and is revoked on July 
28, 1998, under FFDCA section 408(l)(5), residues of the pesticide not 
in excess of the amounts specified in the tolerance remaining in or on 
tomatoes 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 this tolerance 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 tomatoes or whether 
permanent tolerances for this use 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 state other than California to use this pesticide on this 
crop 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).

[[Page 42686]]

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 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,

[[Page 42687]]

EPA has sufficient data to assess the hazards of myclobutanil and to 
make a determination on aggregate exposure, consistent with section 
408(b)(2), for time-limited tolerances for combined residues of 
myclobutanil in or on tomato fruit at 0.3 ppm, tomato puree at 0.6 ppm 
and tomato paste at 1.2 ppm. EPA's assessment of the dietary exposures 
and risks associated with establishing the tolerances 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. 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 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.
    2. Chronic toxicity. EPA has established the RfD for myclobutanil 
at 0.025 mg/kg/day milligrams/kilogram/day (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.
    3. 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 [-
butyl--(4-chlorophenyl)-1H-1,2,4-triazole-1-propanenitrile] 
plus its alcohol metabolite [-(3-hydroxybutyl)--(4-
chlorophenyl)-1H-1,2,4-triazole-1-propanenitrile] (free and bound), in 
or on a variety of raw agricultural commodities at levels ranging from 
5.0 ppm in cherries to 0.02 ppm in eggs. A tolerance has also been 
established (40 CFR 180.443(b)) for the combined residues of 
myclobutanil plus its alcohol metabolite (free and bound) and diol 
metabolite [-(4-chlorophenyl)--(3,4-dihydroxybutyl)-
1H-1,2,4-triazole-1-propanenitrile], in milk at 0.05 ppm. Risk 
assessments were conducted by EPA to assess dietary exposures and risks 
from myclobutanil as follows:
     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).....  0.004255            17%               
Nursing infants (<1 year old)...  0.006359            25%               
Non-Nursing Infants (<1 year      0.018836            75%               
 old).                                                                  
Children (1-6 years old)........  0.011492            46%               
Children (7-12 years old).......  0.006910            28%               
Northeast Region................  0.004539            18%               
Western Region..................  0.004848            19%               
Hispanics.......................  0.005049            20%               
Non-Hispanic Others.............  0.004425            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. Myclobutanil is persistent and not 
considered mobile in soils with the exception of sandy soils. Data are 
not available for its diol 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.
     Chronic exposure and risk. Because the Agency lacks sufficient 
water-related exposure data to complete a comprehensive drinking water 
risk assessment for many pesticides, EPA has commenced and nearly 
completed a process to identify a reasonable yet conservative bounding 
figure for the potential contribution of water-related exposure to the 
aggregate risk posed by a pesticide. In developing the bounding figure, 
EPA estimated residue levels in water for a number of specific 
pesticides using various data sources. The Agency then applied the 
estimated residue levels, in conjunction with appropriate toxicological 
endpoints (RfD's or acute dietary NOEL's) and assumptions about body 
weight and consumption, to calculate, for each pesticide, the increment 
of aggregate risk contributed by consumption of contaminated water. 
While EPA has not yet pinpointed the appropriate bounding figure for 
exposure from contaminated water, the ranges the Agency is continuing 
to examine are all below the level that would cause myclobutanil to 
exceed the RfD if the tolerance being considered in this document were 
granted. The Agency has therefore concluded that the potential 
exposures associated with myclobutanil in water, even at the higher 
levels the Agency is considering as a conservative upper bound, would 
not prevent the Agency from determining that there is a reasonable 
certainty of no harm if the tolerance is granted.
    3. From non-dietary exposure. Myclobutanil is currently registered 
for use on the following residential non-food sites: outdoor 
residential and greenhouse use on annuals and perennials, turf, shrubs, 
trees, flowers. These uses do not constitute a chronic exposure 
scenario, but may constitute a short- to intermediate-term exposure 
scenario. However, EPA lacks sufficient residential-related exposure 
data to complete a comprehensive residential risk assessment for many 
pesticides, including myclobutanil.
    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

[[Page 42688]]

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 risk. Using the partially refined exposure assumptions 
described above under ``Chronic Exposure and Risk'' and taking into 
account the completeness and reliability of the toxicity data, EPA has 
concluded that aggregate dietary exposure (food only) to myclobutanil 
will utilize 17% of the RfD 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. EPA 
has determined that the outdoor registered uses of myclobutanil would 
not fall under a chronic exposure scenario. Despite the potential for 
exposure to myclobutanil in drinking water, using best scientific 
judgement EPA does not expect the aggregate exposure of food and water 
to exceed 100% of the RfD. The Agency 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. 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. Although short-term exposure scenarios may be 
present, based on the lack of acute toxicological endpoints and the low 
percent of RfD occupied, in the best scientific judgement of the 
Agency, aggregate short- and intermediate-term risk will not exceed 
EPA's level of concern. Additionally, the Agency notes that there are 
no indoor residential uses of myclobutanil, thus indoor residential 
exposure is expected to be minimal.

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. Aggregate Risks and Determination of Safety for Infants and Children

    1. Safety factor for infants and children-- a. 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.
    b. 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.
    c. 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.

[[Page 42689]]

    d. 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.
    e. Conclusion. Based on the above, EPA concludes that reliable data 
support use of the standard 100-fold uncertainty factor and that an 
additional factor is not needed to protect the safety of infants and 
children.
    2. Chronic risk. Using the conservative 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.

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 GLC using an Nitrogen/
Phosphorus detector for myclobutanil and an Electron Capture detector 
(Ni63) for residues measured as the alcohol metabolite 
available in PAM II or from the Agency.

C. Magnitude of Residues

    Residues of myclobutanil and its alcohol metabolite are not 
expected to exceed 0.3 ppm in or on tomato fruit, 0.6 ppm in tomato 
puree or 1.2 ppm in tomato paste as a result of this Section 18 use. 
Secondary residues are not expected in animal commodities as no 
feedstuffs are associated with this Section 18 use. Meat/milk/poultry/
egg tolerances have been established as a result of other myclobutanil 
uses.

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 available for myclobutanil. As tomato fields are normally 
rotated, the Agency concludes the following restriction should be added 
to the label for the requested Section 18: Rally treated fields can be 
rotated at any time to crops which are included on the Rally label. All 
other crops may be planted 1 year following applications of Rally 
Agricultural Fungicide.

VI. Conclusion

    Therefore, the tolerance is established for combined residues of 
myclobutanil in or on tomato fruit at 0.3 ppm, tomato puree at 0.6 ppm 
and tomato paste at 1.2 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 October 7, 1997, 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 Docket

    EPA has established a record for this rulemaking under docket 
control number [OPP-300522] (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 Room 1132 of the Public Information and Records 
Integrity Branch, Information Resources and Services Division (7506C), 
Office of Pesticide Programs, Environmental Protection Agency, Crystal 
Mall #2, 1921 Jefferson Davis Hwy., 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

[[Page 42690]]

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

    This final rule establishes tolerances under FFDCA section 408(d). 
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 under FFDCA section 408 (l)(6), 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 General Accounting Office

    Under 5 U.S.C. 801(a)(1)(A), as added by the Small Business 
Regulatory Enforcement Fairness Act of 1996, the Agency has submitted 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 General Accounting Office prior to publication of this rule in 
today's Federal Register. This 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: July 24, 1997.

James Jones,
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. In Sec. 180.443, in paragraph (b), by revising the introductory 
text and alphabetically adding the following commodities to the table 
to read as follows:


Sec. 180.443 Myclobutanil; tolerances for residues.

 *        *        *        *        *        
    (b) Section 18 emergency exemptions. Time-limited tolerances are 
established for residues of the fungicide myclobutanil in connection 
with use of the pesticide under section 18 emergency exemptions granted 
by EPA. These tolerances will expire and are revoked on the dates 
specified in the following table.

                                                                        
------------------------------------------------------------------------
                                                          Expiration/   
            Commodity              Parts per million    Revocation Date 
------------------------------------------------------------------------
                                                                        
*                    *                    *                    *        
                    *                    *                    *         
Tomato, fruit...................  0.3                 July 28, 1998     
Tomato, paste...................  1.2                 July 28, 1998     
Tomato, puree...................  0.6                 July 28, 1998     
                                                                        
 *                    *                    *                    *       
                     *                    *                    *        
------------------------------------------------------------------------

*      *      *      *      *      

[FR Doc. 97-20846 Filed 8-7-97; 8:45 am]
BILLING CODE 6560-50-F