Fludioxonil; Pesticide Tolerances for Emergency Exemptions

Note: EPA no longer updates this information, but it may be useful as a reference or resource.
 [Federal Register: June 24, 1998 (Volume 63, Number 121)]
[Rules and Regulations]               
[Page 34304-34310]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr24jn98-21]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-300676; FRL-5797-5]
RIN 2070-AB78

 
Fludioxonil; 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 
residues of fludioxonil in or on apricots, nectarines, peaches and 
plums. This action is in response to EPA's granting of an emergency 
exemption under section 18

[[Page 34305]]

of the Federal Insecticide, Fungicide, and Rodenticide Act authorizing 
use of the pesticide on stone fruit in California, Georgia and South 
Carolina. This regulation establishes a maximum permissible level for 
residues of fludioxonil 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 tolerances will expire and 
are revoked on December 31, 1999.

DATES: This regulation is effective June 24, 1998. Objections and 
requests for hearings must be received by EPA on or before August 24, 
1998.

ADDRESSES: Written objections and hearing requests, identified by the 
docket control number, [OPP-300676], 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-300676], must also be submitted to: Public 
Information and Records Integrity Branch, Information Resources and 
Services Division (7502C), Office of Pesticide Programs, Environmental 
Protection Agency, 401 M St., SW., Washington, DC 20460. In person, 
bring a copy of objections and hearing requests to Rm. 119, CM #2, 1921 
Jefferson Davis Hwy., Arlington, VA.
    A copy of objections and hearing requests filed with the Hearing 
Clerk may also be submitted electronically by sending electronic mail 
(e-mail) to: opp-docket@epamail.epa.gov. Copies of objections and 
hearing requests must be submitted as an ASCII file avoiding the use of 
special characters and any form of encryption. Copies of objections and 
hearing requests will also be accepted on disks in WordPerfect 5.1/6.1 
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-300676]. 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: Stephen Schaible, 
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) 308-9362; e-mail: 
schaible.stephen@epamail.epa.gov.

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 
residues of the fungicide 4-(2,2-difluoro-1,3-benzodioxol-4-yl)-1H-
pyrrole-3-carbonitrile, hereafter referred to as fludioxonil, in or on 
apricots, nectarines, peaches and plums at 5.0 part per million (ppm). 
These tolerances will expire and are revoked on December 31, 1999. 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 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 Fludioxonil on Apricots, Nectarines, 
Peaches and Plums and FFDCA Tolerances

    The California Department of Pesticide Regulation, South Carolina 
Department of Pesticide Regulation, and Georgia Department of 
Agriculture have requested the use of fludioxonil on stone fruit to 
control brown rot, gray mold rot and Rhizopus rot. These fungal 
pathogens cause latent infection during the period from shuck fall 
through harvest. When a fruit matures its disease resistance declines 
and a latent fungal infection turns into a fruit lesion. Lesioned fruit 
become unmarketable. Harvested fruit were treated with the systemic 
fungicide iprodione up until 1996, when the manufacturer canceled 
postharvest use on stone fruit. During 1997, left over iprodione stock 
was used; many packing houses packed the fruit without a fungicide 
treatment, which resulted in significant yield and quality losses of 
the produce. The only other registered alternative, dicloran, does not 
control these fruit diseases at a commercially acceptable level. 
Significant economic losses to growers are expected without the 
proposed use. EPA has authorized under FIFRA section 18 the use of 
fludioxonil on stone fruit for control of brown rot, gray mold rot, and 
Rhizopus rot in California, Georgia and South Carolina.

[[Page 34306]]

After having reviewed the 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 fludioxonil in or on 
apricots, nectarines, peaches and plums. 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 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 December 31, 1999, under FFDCA section 408(l)(5), 
residues of the pesticide not in excess of the amounts specified in the 
tolerances remaining in or on apricots, nectarines, peaches and plums 
after that date will not be unlawful, provided the pesticide is applied 
in a manner that was lawful under FIFRA, and the residues do not exceed 
a level that was authorized by these tolerances at the time of that 
application. 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 fludioxonil 
meets EPA's registration requirements for use on apricots, nectarines, 
peaches and plums 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 fludioxonil 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, 
Georgia and South Carolina 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 fludioxonil, 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.
    Short-term risk results from exposure to the pesticide for a period 
of 1-7 days, and therefore overlaps with the acute risk assessment. 
Historically, this risk assessment was intended to address primarily 
dermal and inhalation exposure which could result, for example, from 
residential pesticide applications. However, since enaction of FQPA, 
this assessment has been expanded to include both dietary and non-
dietary sources of exposure, and will typically consider exposure from 
food, water, and residential uses when reliable data are available. In 
this assessment, risks from average food and water exposure, and high-
end residential exposure, are aggregated. High-end exposures from all 
three sources are not typically added because of the very low 
probability of this occurring in most cases, and because the other 
conservative assumptions built into the assessment assure adequate 
protection of public health. However, for cases in which high-end 
exposure can reasonably be expected from multiple sources (e.g. 
frequent and widespread homeowner use in a specific geographical area), 
multiple high-end risks will be aggregated and

[[Page 34307]]

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 yr. 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 
fludioxonil and to make a determination on aggregate exposure, 
consistent with section 408(b)(2), for time-limited tolerances for 
residues of fludioxonil on apricots, nectarines, peaches and plums at 
5.0 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 fludioxonil are 
discussed below.
    1. Acute toxicity. No endpoint was identified for acute dietary 
exposure. The EPA has concluded that the toxicology database does not 
suggest the need for this assessment, as no acute effects are expected 
to result from exposure to fludioxonil.
    2. Chronic toxicity. EPA has established the RfD for fludioxonil at 
0.03 milligrams/kilogram/day (mg/kg/day). This RfD is based on a NOEL 
of 3.3 mg/kg/day, taken from a chronic feeding study in dogs, and an 
uncertainty factor of 100. The effect observed at the LEL of 35.5 mg/
kg/day was decreased body weight gain in females.
    3. Carcinogenicity. Fludioxonil has been classified as a Group D- 
not classifiable as to human carcinogenicity- chemical by the Cancer 
Peer Review Committee.

B. Exposures and Risks

    1. From food and feed uses. A tolerance has been established (40 
CFR 180.516) for the residues of fludioxonil in or on potatoes at 0.02 
ppm. Fludioxonil is currently registered for use as a seed treatment on 
potatoes, popcorn, field and sweet corn, and sorghum, as well as for 
use in greenhouses on nonfood crops. Since residues in corn and sorghum 
are non-quantifiable, these uses do not require tolerances. Risk 
assessments were conducted by EPA to assess dietary exposures and risks 
from fludioxonil as follows:
    Chronic exposure and risk. Tolerance level residues and 100% crop 
treated were assumed to calculate TMRCs for the U.S. population and 
population subgroups from residues on potatoes and stone fruit. Chronic 
exposure from food uses of fludioxonil represents 6% of the RfD for the 
U.S. population and 52% of the RfD for non-nursing infants (<1yr), the 
subgroup most highly exposed.
    2. From drinking water. In light of the use pattern, a post-harvest 
spray treatment for stone fruit which would occur indoors, along with 
the currently registered uses- seed treatments for potato and corn 
(field & sweet), popcorn, and sorghum, and ornamental plants grown in 
greenhouses, or other enclosed structures- fludioxonil is not expected 
to impact ground or surface waters. As a result, the likelihood of 
residues of fludioxonil in drinking water is negligible. Therefore, EPA 
concludes that a drinking water risk assessment is not required at this 
time. Therefore, there is no drinking water risk assessment to 
aggregate with the chronic dietary (food sources) risk assessment.
    3. From non-dietary exposure. Fludioxonil is currently not 
registered for use on residential, non-food sites; therefore, no non-
occupational, non-dietary exposure is expected. (Please remove all 
language in this section from this point on).
    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

[[Page 34308]]

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 fludioxonil 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, 
fludioxonil 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 fludioxonil has a common mechanism of toxicity 
with other substances.

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

    Chronic risk. Using the TMRC exposure assumptions described above, 
EPA has concluded that aggregate exposure to fludioxonil from food will 
utilize 6% of the RfD for the U.S. population. The major identifiable 
subgroup with the highest aggregate exposure is non-nursing infants (<1 
yr) (discussed below). 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. Given that the proposed use pattern 
is a postharvest spray treatment for stone fruit which would occur 
indoors, and that currently registered uses are for seed treatments at 
a low application rate and for ornamental plants grown in greenhouses 
or other enclosed structures, fludioxonil is not expected to impact 
ground or surface water; the likelihood of residues in drinking water 
is negligible. Currently, there are no registered residential uses of 
fludioxonil. EPA concludes that there is a reasonable certainty that no 
harm will result from aggregate exposure to fludioxonil residues.

D. 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 fludioxonil, EPA considered data from 
developmental toxicity studies in the rat and rabbit and a two-
generation reproduction study in the rat. The developmental toxicity 
studies are designed to evaluate adverse effects on the developing 
organism resulting from maternal pesticide exposure during gestation. 
Reproduction studies provide information relating to effects from 
exposure to the pesticide on the reproductive capability of mating 
animals and data on systemic toxicity.
    FFDCA section 408 provides that EPA shall apply an additional 
tenfold margin of safety for infants and children in the case of 
threshold effects to account for pre-and post-natal toxicity and the 
completeness of the database unless EPA determines that a different 
margin of safety will be safe for infants and children. Margins of 
safety are incorporated into EPA risk assessments either directly 
through use of a MOE analysis or through using uncertainty (safety) 
factors in calculating a dose level that poses no appreciable risk to 
humans. EPA believes that reliable data support using the standard 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 rat developmental study, 
the maternal (systemic) NOEL was 100 mg/kg/day, based on reduction in 
mean body weight gain in dams during gestation period at the lowest-
observed-effect-level (LOEL) of 1,000 mg/kg/day. The developmental 
(fetal) NOEL was 100 mg/kg/day, based on increased fetal and litter 
incidence of dilated renal pelvis and dilated ureter at the LOEL of 
1,000 mg/kg/day. In the rabbit developmental toxicity study, the 
maternal (systemic) NOEL was 10 mg/kg/day, based on decreased body 
weight gains and food efficiency at the LOEL of 100 mg/kg/day. The 
developmental (pup) NOEL was 300 mg/kg/day, the highest dose tested.
    iii. Reproductive toxicity study. In the two-generation 
reproductive toxicity study in rats, the parental (systemic) NOEL was 
22.13 mg/kg/day (males) and 24.24 mg/kg/day (females), based on 
clinical signs and decreased body weight, body weight gain and food 
consumption at the LOEL of 221.6 mg/kg/day (males) and 249.7 mg/kg/day 
(females). The reproductive/developmental (pup) NOEL was 22.13 mg/kg/
day (males) and 24.24 mg/kg/day (females), based on reduced pup weights 
at the LOEL of 221.6 mg/kg/day (males) and 249.7 mg/kg/day (females).
    iv. Pre- and post-natal sensitivity. The toxicological data base 
for evaluating pre- and post-natal toxicity for fludioxonil is complete 
with respect to current data requirements. There are no pre- or post-
natal toxicity concerns for infants and children, based on the results 
of the rat and rabbit developmental toxicity studies and the two-
generation rat reproductive toxicity study.
    v. Conclusion. EPA concludes that reliable data support the removal 
of the additional uncertainty factor; the standard hundredfold 
uncertainty factor is adequate 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 
fludioxonil

[[Page 34309]]

from food will utilize 52% of the RfD for infants and children. 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. Exposure from drinking water and residential uses is not 
expected. EPA concludes that there is a reasonable certainty that no 
harm will result to infants and children from aggregate exposure to 
fludioxonil residues.

V. Other Considerations

A. Metabolism In Plants and Animals

    The nature of the residue in stone fruit is adequately understood 
based on a metabolism study submitted for seed treatment use on 
potatoes. The residue of concern is the parent compound, fludioxonil, 
only. There are no livestock feed items associated with the proposed 
use on stone fruit. Therefore, the nature of the residue in animals is 
not germane to these section 18 requests or to the establishment of 
these tolerances.

B. Analytical Enforcement Methodology

    Adequate enforcement methodology (GC/NPD) was provided with the 
Applicants' submissions to enforce the tolerance expression 
(modifications to Methods AG-597B and AG-664).

C. Magnitude of Residues

    Residues of fludioxonil are not expected to exceed 5.0 ppm in/on 
apricots, nectarines, peaches, and plums as a result of the proposed 
section 18 use. Secondary residues are not expected in animal 
commodities as there are no feed items associated with this section 18 
use.

D. International Residue Limits

    No CODEX, Canadian, or Mexican MRLs/tolerances have been 
established for residues of fludioxonil on stone fruit.

E. Rotational Crop Restrictions

    The proposed post-harvest use does not involve application of 
fludioxonil to fields of growing crops. Therefore, rotational crop 
restrictions are not relevant to this discussion.

VI. Conclusion

    Therefore, tolerances are established for residues of fludioxonil 
in apricots, nectarines, peaches and plums at 5.0 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 August 24, 1998, file written objections to any 
aspect of this regulation and may also request a hearing on those 
objections. Objections and hearing requests must be filed with the 
Hearing Clerk, at the address given above (40 CFR 178.20). A copy of 
the objections and/or hearing requests filed with the Hearing Clerk 
should be submitted to the OPP docket for this rulemaking. The 
objections submitted must specify the provisions of the regulation 
deemed objectionable and the grounds for the objections (40 CFR 
178.25). Each objection must be accompanied by the fee prescribed by 40 
CFR 180.33(i). If a hearing is requested, the objections must include a 
statement of the factual issues on which a hearing is requested, the 
requestor's contentions on such issues, and a summary of any evidence 
relied upon by the requestor (40 CFR 178.27). A request for a hearing 
will be granted if the Administrator determines that the material 
submitted shows the following: There is genuine and substantial issue 
of fact; there is a reasonable possibility that available evidence 
identified by the requestor would, if established, resolve one or more 
of such issues in favor of the requestor, taking into account 
uncontested claims or facts to the contrary; and resolution of the 
factual issues in the manner sought by the requestor would be adequate 
to justify the action requested (40 CFR 178.32). Information submitted 
in connection with an objection or hearing request may be claimed 
confidential by marking any part or all of that information as CBI. 
Information so marked will not be disclosed except in accordance with 
procedures set forth in 40 CFR part 2. A copy of the information that 
does not contain CBI must be submitted for inclusion in the public 
record. Information not marked confidential may be disclosed publicly 
by EPA without prior notice.

VIII. Public Record and Electronic Submissions

    EPA has established a record for this rulemaking under docket 
control number [OPP-300676] (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 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 Hwy., Arlington, VA.
    Electronic comments may be sent directly to EPA at:
    opp-docket@epamail.epa.gov.


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

IX. Regulatory Assessment Requirements

    This final rule establishes tolerances under FFDCA section 
408(l)(6) 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

[[Page 34310]]

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 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 this 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: June 8, 1998.

Peter Caulkins,

Acting Director, Registration Division, Office of Pesticide Programs.
    Therefore, 40 CFR chapter I is amended as follows:

PART 180-- [AMENDED]

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

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

    2. In Sec. 180.516, by adding text to paragraph (b) to read as 
follows:


Sec. 180.516  Fludioxonil; tolerances for residues.

* * * * *
    (b) Section 18 emergency exemptions. Time-limited tolerances are 
established for residues of the fungicide fludioxonil (4-(2,2-difluoro-
1,3-benzodioxol-4-yl)-1H-pyrrole-3-carbonitrile) in connection with use 
of the pesticide under section 18 emergency exemptions granted by EPA. 
The tolerances will expire and are revoked on the dates specified in 
the following table:

                                                                        
------------------------------------------------------------------------
                                                          Expiration/   
            Commodity              Parts per million    revocation date 
------------------------------------------------------------------------
Apricots........................  5.0                 12/31/99          
Nectarines......................  5.0                 12/31/99          
Peaches.........................  5.0                 12/31/99          
Plums...........................  5.0                 12/31/99          
------------------------------------------------------------------------

* * * * *

[FR Doc. 98-16677 Filed 6-23-98; 8:45 am]
BILLING CODE 6560-50-F
Fludioxonil; Pesticide Tolerances for Emergency Exemptions

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