PMEP Home Page --> Pesticide Active Ingredient Information --> Insecticides and Miticides --> Insecticides, R to Z --> Tebufenozide --> Tebufenozide - Pesticide Tolerance 6/99

Tebufenozide - Pesticide Tolerance 6/99

[Federal Register: July 14, 1999 (Volume 64, Number 134)]
[Rules and Regulations]
[Page 37863-37870]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr14jy99-9]

-----------------------------------------------------------------------

ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-300886; FRL-6088-8]
RIN 2070-AB78
Tebufenozide; Benzoic Acid, 3,5-dimethyl-1-(1,1-dimethylethyl)-2-
(4-ethylbenzoyl) hydrazide; Pesticide Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.

-----------------------------------------------------------------------

SUMMARY: This regulation establishes a tolerance for residues of
tebufenozide in or on kiwifruit. Rohm and Haas Company requested the
tolerance under the Federal Food, Drug, and Cosmetic Act, as amended by
the Food Quality Protection Act of 1996.

DATES: This regulation is effective July 14, 1999. Objections and
requests for hearings must be received by EPA on or before September
13, 1999.

ADDRESSES: Written objections and hearing requests, identified by the
docket control number, [OPP-300886], 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-300886], 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, Crystal
Mall 2 (CM #2), 1921 Jefferson Davis Hwy., Arlington, VA.
    A copy of objections and hearing requests filed with the Hearing
Clerk may be submitted electronically by sending electronic mail (e-
mail) to: opp-docket@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

[[Page 37864]]

the docket control number [OPP-300886]. 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: Joseph M. Tavano,
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: Rm. 222, CM #2,
1921 Jefferson Davis Hwy., Arlington, VA, (703) 305-6411,
tavanojoseph@epa.gov.

SUPPLEMENTARY INFORMATION: In the Federal Register of August 19, 1998
(63 FR 44439) (FRL-6019-6), EPA issued a notice pursuant to section 408
of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a as
amended by the Food Quality Protection Act of 1996 (FQPA) (Public Law
104-170) announcing the filing of a pesticide petition (PP) for
tolerance by Rohm and Haas Company, 100 Independence Mall West,
Philadelphia, PA 19106-2399. This notice included a summary of the
petition prepared by Rohm and Haas Company, the registrant. There were
no comments received in response to the notice of filing.
    The petition requested that 40 CFR 180.482 be amended by
establishing a tolerance for residues of the insecticide tebufenozide,
in or on kiwifruit at 0.5 part per million (ppm). Tebufenozide controls
light brown apple moth, green-headed leafroller, and brown-headed
leafroller on kiwifruit.

I. Background and Statutory Findings

    Section 408(b)(2)(A)(i) of the FFDCA allows EPA to establish a
tolerance (the legal limit for a pesticide chemical residue in or on a
food) only if EPA determines that the tolerance is "safe." Section
408(b)(2)(A)(ii) defines "safe" to mean that "there is a reasonable
certainty that no harm will result from aggregate exposure to the
pesticide chemical residue, including all anticipated dietary exposures
and all other exposures for which there is reliable information." This
includes exposure through drinking water and in residential settings,
but does not include occupational exposure. Section 408(b)(2)(C)
requires EPA to give special consideration to exposure of infants and
children to the pesticide chemical residue in establishing a tolerance
and to "ensure that there is a reasonable certainty that no harm will
result to infants and children from aggregate exposure to the pesticide
chemical residue...."
    EPA performs a number of analyses to determine the risks from
aggregate exposure to pesticide residues. For further discussion of the
regulatory requirements of section 408 and a complete description of
the risk assessment process, see the final rule on Bifenthrin Pesticide
Tolerances (62 FR 62961, November 26, 1997) (FRL-5754-7).

II. Aggregate Risk Assessment and Determination of Safety

    Consistent with section 408(b)(2)(D), EPA has reviewed the
available scientific data and other relevant information in support of
this action. EPA has sufficient data to assess the hazards of
tebufenozide, benzoic acid, 3,5-dimethyl-1-(1,1-dimethylethyl)-2-(4-
ethylbenzoyl) hydrazide and to make a determination on aggregate
exposure, consistent with section 408(b)(2), for a tolerance for
residues of tebufenozide on imported kiwifruit at 0.5 ppm respectively.
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 tebufenozide are
discussed in this unit.
    1. Acute toxicity studies with technical grade: Oral
LD50 in the rat is > 5 grams for males and females -
Toxicity Category IV; dermal LD50 in the rat is = 5,000
milligrams/kilograms (mg/kg) for males and females - Toxicity Category
III; inhalation LC50 in the rat is >4.5 mg/l - Toxicity
Category III; primary eye irritation study in the rabbit is a non-
irritant; primary skin irritation in the rabbit >5mg - Toxicity
Category IV. Tebufenozide is not a sentizer.
    2. In a 21-day dermal toxicity study, Crl:CD rats (6/sex/dose)
received repeated dermal administration of either the technical 96.1%
product RH-75,992 at 1,000 mg/kg/day (Limit-Dose) or the formulation
23.1% active ingredient (a.i.) product RH-755,992 2F at 0, 62.5, 250,
or 1,000 mg/kg/day, 6 hours/day, 5 days/week for 21 days. Under
conditions of this study, RH-75,992 Technical or RH-75,992 2F
demonstrated no systemic toxicity or dermal irritation at the Highest
Dose Tested (HDT) 1,000 mg/kg during the 21-day study. Based on these
results, the No Observable Adverse Effect Level (NOAEL) for systemic
toxicity and dermal irritation in both sexes is 1,000 mg/kg/day HDT. A
Lowest Observable Adverse Effect Level (LOAEL) for systemic toxicity
and dermal irritation was not established.
    3. A 1-year dog feeding study with a LOAEL of 250 ppm (9 mg/kg/day
for male and female dogs) based on decreases in Red Blood Cells (RBC),
Hematocrit (HCT), and Hemoglobin (HGB), increases in Heinz bodies,
methemoglobin, Mean Corpuscular Volume (MCV), Mean Corpuscular
Hematocrit (MCH), reticulocytes, platelets, plasma total bilirubin,
spleen weight, and spleen/body weight ratio, and liver/body weight
ratio. Hematopoiesis and sinusoidal engorgement occurred in the spleen,
and hyperplasia occurred in the marrow of the femur and sternum. The
liver showed an increased pigment in the Kupffer cells. The NOAEL for
systemic toxicity in both sexes is 50 ppm (1.9 mg/kg/day).
    4. An 18-month mouse carcinogenicity study with no carcinogenicity
observed at dosage levels up to and including 1,000 ppm.
    5. A 2-year rat carcinogenicity study with no carcinogenicity
observed at dosage levels up to and including 2,000 ppm (97 mg/kg/day
and 125 mg/kg/day for males and females, respectively).
    6. In a prenatal developmental toxicity study in Sprague-Dawley
rats (25/group) Tebufenozide was administered on gestation days 6-15 by
gavage in aqueous methyl cellulose at dose levels of 50, 250, or 1,000
mg/kg/day and a dose volume of 10 milliliter (ml)/kg. There was no
evidence of maternal or developmental toxicity; the maternal and
developmental toxicity NOAEL was 1,000 mg/kg/day.
    7. In a prenatal developmental toxicity study conducted in New
Zealand white rabbits (20/group) tebufenozide was administered in 5 ml/
kg of aqueous methyl cellulose at gavage doses of 50, 250, or 1,000 mg/
kg/day on gestation days 7-19. No evidence of maternal or developmental
toxicity was observed; the maternal and developmental toxicity NOAEL
was 1,000 mg/kg/day.
    8. In a 1993 2-generation reproduction study in Sprague-Dawley
rats, tebufenozide was administered at dietary concentrations of 0, 10,
150, or 1,000 ppm (0, 0.8, 11.5, or 154.8 mg/kg/day for males and 0,
0.9, 12.8, or 171.1 mg/kg/day for females). The parental systemic NOAEL
was 10 ppm (0.8/0.9 mg/kg/day for males and females,

[[Page 37865]]

respectively) and the LOAEL was 150 ppm (11.5/12.8 mg/kg/day for males
and females, respectively) based on decreased body weight, body weight
gain, and food consumption in males, and increased incidence and/or
severity of splenic pigmentation. In addition, there was an increased
incidence and severity of extramedullary hematopoiesis at 2,000 ppm.
The reproductive NOAEL was 150 ppm (11.5/12.8 mg/kg/day for males and
females, respectively) and the LOAEL was 2,000 ppm (154.8/171.1 mg/kg/
day for males and females, respectively) based on an increase in the
number of pregnant females with increased gestation duration and
dystocia. Effects in the offspring consisted of decreased number of
pups per litter on postnatal days 0 and/or 4 at 2,000 ppm (154.8/171.1
mg/kg/day for males and females, respectively) with a NOAEL of 150 ppm
(11.5/12.8 mg/kg/day for males and females, respectively).
    9. In a 1995 2-generation reproduction study in rats tebufenozide
was administered at dietary concentrations of 0, 25, 200, or 2,000 ppm
(0, 1.6, 12.6, or 126.0 mg/kg/day for males and 0, 1.8, 14.6, or 143.2
mg/kg/day for females). For parental systemic toxicity, the NOAEL was
25 ppm (1.6/1.8 mg/kg/day in males and females, respectively), and the
LOAEL was 200 ppm (12.6/14.6 mg/kg/day in males and females), based on
histopathological findings (congestion and extramedullary
hematopoiesis) in the spleen. Additionally, at 2,000 ppm (126.0/143.2
mg/kg/day in M/F), treatment-related findings included reduced parental
body weight gain and increased incidence of hemosiderin-laden cells in
the spleen. Columnar changes in the vaginal squamous epithelium and
reduced uterine and ovarian weights were also observed at 2,000 ppm,
but the toxicological significance was unknown. For offspring, the
systemic NOAEL was 200 ppm (12.6/14.6 mg/kg/day in males and females),
and the LOAEL was 2,000 ppm (126.0/143.2 mg/kg/day in M/F) based on
decreased body weight on postnatal days 14 and 21.
    10. Several mutagenicity tests which were all negative. These
include an Ames assay with and without metabolic activation, an in vivo
cytogenetic assay in rat bone marrow cells, and in vitro chromosome
aberration assay in Chinese Hampster Ovary (CHO) cells, a CHO/
Hypoxanthine guanine phophoribosyl transferase (HGPRT) assay, a reverse
mutation assay with E. Coli, and an unscheduled DNA synthesis assay
Unscheduled DNA Synthesis (UDS) in rat hepatocytes.
    11. The pharmacokinetics and metabolism of tebufenozide were
studied in female Sprague-Dawley rats (3-6/sex/group) receiving a
single oral dose of 3 or 250 mg/kg of RH-5992, 14C labeled
in 1 of 3 positions (A-Ring, B-Ring or N-butylcarbon). The extent of
absorption was not established. The majority of the radio labeled
material was eliminated or excreted in the feces within 48 hours; small
amounts (1 to 7% of the administered dose) were excreted in the urine
and only traces were excreted in expired air or remained in the
tissues. There was no tendency for bioacculmulation. Absorption and
excretion were rapid.
    A total of 11 metabolites, in addition to the parent compound, were
identified in the feces; the parent compound accounted for 96 to 99% of
the administered radioactivity in the high dose group and 35 to 43% in
the low dose group. No parent compound was found in the urine; urinary
metabolites were not characterized. The identity of several fecal
metabolites was confirmed by mass spectral analysis and other fecal
metabolites were tentatively identified by cochromatography with
synthetic standards. A pathway of metabolism was proposed based on
these data. Metabolism proceeded primarily by oxidation of the 3 benzyl
carbons, 2 methyl groups on the B-ring and an ethyl group on the A-ring
to alcohols, aldehydes or acids. The type of metabolite produced varies
depending on the position oxidized and extent of oxidation. The butyl
group on the quaternary nitrogen also can be leaved (minor), but there
was no fragmentation of the molecule between the benzyl rings.
    No qualitative differences in metabolism were observed between
sexes, when high or low dose groups were compared or when different
labeled versions of the molecule were compared.
    12. The absorption and metabolism of tebufenozide were studied in a
group of male and female bile-duct cannulated rats. Over a 72-hour
period, biliary excretion accounted for 30% (Female (F)) to 34% (Male
(M)) of the administered dose while urinary excretion accounted for
equivalent to 5% of the administered dose and the carcass accounted for
<0.5% of the administered dose for both males and females. Thus,
systemic absorption (percent of dose recovered in the bile, urine and
carcass) was 35% (F) to 39% (M). The majority of the radioactivity in
the bile 20% (F) to 24% (M) of the administered dose was excreted
within the first 6 hours postdosing indicating rapid absorption.
Furthermore, urinary excretion of the metabolites was essentially
complete within 24 hours postdosing. A large amount, 67% (M) to 70% (F)
of the administered dose was unabsorbed and excreted in the feces by 72
hours. Total recovery of radioactivity was 105% of the administered
dose.
    A total of 13 metabolites were identified in the bile; the parent
compound was not identified (i.e. - unabsorbed compound) nor were the
primary oxidation products seen in the feces in the pharmacokinetics
study. The proposed metabolic pathway proceeded primary by oxidation of
the benzylic carbons to alcohols, aldehydes or acids. Bile contained
most of the other highly oxidized products found in the feces. The most
significant individual bile metabolites accounted for 5% to 18% of the
total radioactivity (M and/or F). Bile also contained the previously
undetected (in the pharmacokinetics study) "A" Ring ketone and the
"B"Ring diol. The other major components were characterized as high
molecular weight conjugates. No individual bile metabolite accounted
for >5% of the total administered dose. Total bile radioactivity
accounted for equivalent to 17% of the total administered dose.
    No major qualitative differences in biliary metabolites were
observed between sexes. The metabolic profile in the bile was similar
to the metabolic profile in the feces and urine.

B. Toxicological Endpoints

    1. Acute toxicity. Toxicity observed in oral toxicity studies were
not attributable to a single dose (exposure). No neuro or systemic
toxicity was observed in rats given a single oral administration of
tebufenozide at 0, 500, 1,000, or 2,000 mg/kg. No maternal or
developmental toxicity was observed following oral administration of
tebufenozide at 1,000 mg/kg/day (Limit-Dose) during gestation to
pregnant rats or rabbits. Thus, the risk from acute exposure is
considered negligible.
    2. Short- and intermediate termtoxicity.  No dermal or systemic
toxicity was seen in rats receiving 15 repeated dermal applications of
the technical 97.2% product at 1,000 mg/kg/day (Limit- Dose) as well as
a formulated 23% a.i. product at 0, 62.5, 250, or 1,000 mg/kg/day over
a 21-day period. The Agency noted that in spite of the hematological
effects seen in the dog study, similar effects were not seen in the
rats receiving the compound via the dermal route indicating poor dermal
absorption. Also, no developmental endpoints of concern were evident
due to the lack of developmental toxicity in

[[Page 37866]]

either rat or rabbit studies. This risk is considered to be negligable.
    3. Chronic toxicity. EPA has established the chronic population
adjusted dose (cPAD) for tebufenozide at 0.018 mg/kg/day. This
Reference Dose (RfD) is based on a NOAEL of 1.8 mg/kg/day and an
uncertainty factor (UF) of 100. The NOAEL was established from the
chronic toxicity study in dogs where the NOAEL was 1.8 mg/kg/day based
on growth retardation, alterations in hematology parameters, changes in
organ weights, and histopathological lesions in the bone, spleen and
liver at 8.7 mg/kg/day. EPA determined that the 10x factor to protect
children and infants (as required by FQPA) should be reduced to 1x.
Therefore, the cPAD is the same as the RfD: 0.018 mg/kg/day. Reducing
the 10x factor to 1x is supported by the following factors.
    i. Developmental toxicity studies showed no increased sensitivity
in fetuses when compared to maternal animals following in utero
exposures in rats and rabbits.
    ii. Multi-generation reproduction toxicity studies in rats showed
no increased sensitivity in pups as compared to adults and offspring.
    iii. There are no data gaps.
    4.  Carcinogenicity. Tebufenozide has been classified as a Group E,
"no evidence of carcinogenicity for humans," chemical by EPA.

C. Exposures and Risks

    1. From food and feed uses. Tolerances have been established (40
CFR 180.482) for the residues of tebufenozide in or on a variety of raw
agricultural commodities. In today's action a tolerance will be
established for the residues of tebufenozide in or on the raw
agricultural commodity, kiwifruit at 0.50 ppm. Risk assessments were
conducted by EPA to assess dietary exposures from tebufenozide as
follows:
    Section 408(b)(2)(F) states that the Agency may use data on the
actual percent of food treated (PCT) for assessing chronic dietary risk
only if the Agency can make the following findings: That the data used
are reliable and provide a valid basis to show what percentage of the
food derived from such crop is likely to contain such pesticide
residue; that the exposure estimate does not underestimate exposure for
any significant subpopulation group; and if data are available on
pesticide use and food consumption in a particular area, the exposure
estimate does not understate exposure for the population in such area.
In addition, the Agency must provide for periodic evaluation of any
estimates used. To provide for the periodic evaluation of the estimate
of PCT as required by the section 408(b)(2)(F), EPA may require
registrants to submit data on PCT.
    The Agency used PCT information as follows:
    Estimates of PCT were used for the following crops. In all cases
the maximum estimate was used.
    Almonds: Average <1% Maximum <1%
    Apples: Average 1% Maximum 2%
    Beans/Peas, Dry: Average 0% Maximum 1%
    Cotton: Average 1% Maximum 4%
    Sugarcane: Average 3% Maximum 5%
    Walnuts: Average 10% Maximum 16%
    The Agency believes that the three conditions, discussed in section
408 (b)(2)(F) in this unit concerning the Agency's responsibilities in
assessing chronic dietary risk findings, have been met. The PCT
estimates are derived from Federal and private market survey data,
which are reliable and have a valid basis. 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 the PCT,
the Agency is reasonably certain that the percentage of the food
treated is not likely to be underestimated. The regional consumption
information and consumption information for significant subpopulations
is taken into account through EPA's computer-based model for evaluating
the exposure of significant subpopulations including several regional
groups. Use of this consumption information in EPA's risk assessment
process ensures that EPA's exposure estimate does not understate
exposure for any significant subpopulation group and allows the Agency
to be reasonably certain that no regional population is exposed to
residue levels higher than those estimated by the Agency. Other than
the data available through national food consumption surveys, EPA does
not have available information on the regional consumption of food to
which tebufenozide may be applied in a particular area.
    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 1-day or single exposure. Toxicity observed in oral toxicity
studies were not attributable to a single dose (exposure). No neuro or
systemic toxicity was observed in rats given a single oral
administration of tebufenozide at 0, 500, 1,000 or 2,000 mg/kg. No
maternal or developmental toxicity was observed following oral
administration of tebufenozide at 1,000 mg/kg/day (Limit-Dose) during
gestation to pregnant rats or rabbits. This risk is considered to be
negligable.
    ii. Chronic exposure and risk.  The residue of concern for
tebufenozide in plant and animal commodities is the parent compound per
se. In performing this analysis, EPA used the Dietary Exposure
Evaluation Model (DEEM), which incorporates data from the Continuing
Survey of Food Intakes by Individuals (CSFII), 1989 to 1992. Some
refinement to the food exposure estimates was made through the use of
PCT data. The resulting estimated food exposures for the United States
(U.S.) population and various DEEM population subgroups are shown in
the following table. Of these subgroups, the highest exposure is
projected for children ages 1-6, whose chronic intake is estimated at
73% of the RfD. Generally, in the absence of additional safety factors,
EPA is not concerned with exposures less than 100% of the RfD. Thus,
for all populations, the chronic human health risk from exposure to
tebufenozide in foods is below EPA's level of concern. This estimate
should be considered moderately refined. Further refinement to the
exposure estimate, through the use of anticipated residues, more PCT
data, or market-basket surveys, would likely result in lower exposure
estimates.

      Chronic Dietary Exposure to Tebufenozide and Associated Risk
------------------------------------------------------------------------
                                    Eposure, mg/kg
     Population Subgroup\1\           body wt/day          % of cPAD
------------------------------------------------------------------------
U.S. Pop. (48 contiguious         0.006549..........  36
 states).
U.S. Pop. (autumn)..............  0.006634..........  37
U.S. Pop. (winter)..............  0.006742..........  38
U.S. Pop. (Western region)......  0.007230..........  40
U.S. Pop. (Pacific region)......  0.007419..........  41
Non-hispanic Blacks.............  0.006618..........  37
Not Hispanic, Black, or White...  0.007867..........  44
All Infants (< 1 yr)............  0.009369..........  52
Non-nursing Infants (< 1 yr)....  0.011223..........  62
Children (1-6 yr)...............  0.013202..........  73
Children (7-12 yr)..............  0.008301..........  46
Females (13+ yr, nursing).......  0.007604..........  42
Males (20+ yr)..................  0.005161..........  29
------------------------------------------------------------------------
\1\Subpopulations include the general U.S. population, infants and

  children, females, males, and any other groups whose exposure is
  greater than that of the general U.S. population.

[[Page 37867]]

    2. From drinking water-- i. Acute exposure and risk.  Because no
acute dietary endpoint was determined, the Agency concludes that there
is a reasonable certainty of no harm from acute exposure from drinking
water.
    ii. Chronic exposure and risk. Submitted environmental fate studies
suggest that tebufenozide ranges from moderately persistent to
persistent and is mobile; thus, tebufenozide could potentially leach to
ground water and runoff to surface water under certain environmental
conditions. There is no established Maximum Contaminant Level (MCL) for
residues of tebufenozide in drinking water. No drinking water Health
Advisories have been issued for tebufenozide. There is no entry for
tebufenozide in the "Pesticides in Groundwater Database."
    Monitoring data are not available to assess the human exposure to
tebufenozide via drinking water. In lieu of these, EPA has calculated
the Tier I estimated concentrations in drinking water (DWECs) for
tebufenozide using GENEEC (surface water) and SCIGROW (ground water)
for use in the human health risk assessment. The maximum application
rate for tebufenozide is 0.25 pound (lb) a.i. with 5 applications per
year on pecans. This application scenario was used to calculate the
DWECs for the human health risk assessment. Due to the wide range of
aerobic soil half-life values, GENEEC and SCIGROW were run based on
aerobic half-lives of 66 (California Loam) and 729 (worst-case soil
with low microbial activity) days. For surface water, the chronic (56-
day) values are 13.3 parts per billion (ppb) and 16.5 ppb for the half-
lives of 66 and 729 days, respectively. The ground water screening
concentrations are 0.16 ppb and 1.04 ppb for the half-lives of 66 and
729 days, respectively. These values represent upper-bound estimates of
the concentrations that might be found in surface and ground water due
to the use of tebufenozide on pecans.
    In performing this risk assessment, EPA has calculated drinking
water levels of comparison (DWLOCs) for each of the DEEM population
subgroups. Within each subgroup, the population with the highest
estimated exposure was used to determine the maximum concentration of
tebufenozide that can occur in drinking water without causing an
unacceptable human health risk. As a comparison value, EPA has used the
16.5 ppb value in this risk assessment, as this represents a worst-case
scenario. The DWLOCs for tebufenozide are above the DWEC of 16.5 ppb
for all population subgroups. Therefore, the human health risk from
exposure to tebufenozide through drinking water in not likely to exceed
EPA's level of concern.
    3. From non-dietary exposure. Tebufenozide is not currently
registered for use on any residential non-food sites. Therefore there
is no non-dietary chronic, short- or intermediate-term exposure
scenario.
    4. Cumulative exposure to substances with a 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."
    EPA does not have, at this time, available data to determine
whether tebufenozide 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,
tebufenozide 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 tebufenozide has a common mechanism of
toxicity with other substances. For information regarding EPA's efforts
to determine which chemicals have a common mechanism of toxicity and to
evaluate the cumulative effects of such chemicals, see the final rule
for Bifenthrin Pesticide Tolerances (62 FR 62961, November 26, 1997).

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

    1. Acute risk. Since no acute toxicological endpoints were
established, no acute aggregate risk exists.
    2. Chronic risk. Using the Anticipated Residue Contribution (ARC)
exposure assumptions described in this unit, EPA has concluded that
aggregate exposure to tebufenozide from food will utilize 36% of the
cPAD for the U.S. population. The major identifiable subgroup with the
highest aggregate exposure is children (1-6 years old) at 73% of the
cPAD and is discussed below. Submitted environmental fate studies
suggest that tebufenozide is moderately persistent to persistent and
mobile; thus, tebufenozide could potentially leach to ground water and
runoff to surface water under certain environmental conditions. The
modeling data for tebufenozide indicate levels less than EPA's DWLOC.
EPA generally has no concern for exposures below 100% of the PAD
because the PAD represents the level at or below which daily aggregate
dietary exposure over a lifetime will not pose appreciable risks to
human health. There are no registered residential uses of tebufenozide.
Since there is no potential for exposure to tebufenozide from
residential uses, EPA does not expect the aggregate exposure to exceed
100% of the PAD.
    3. Short- and intermediate-term risk. Short- and intermediat-term
aggregate exposure takes into account chronic dietary food and water
(considered to be a background exposure level) plus indoor and outdoor
residential exposure.
    Since there are currently no registered indoor or outdoor
residential non-dietary uses of tebufenozide and no short- or
intermediate-term toxic endpoints, short- or intermediate-term
aggregate risks do not exist.
    4. Aggregate cancer risk for U.S. population. Since, tebufenozide
has been classified as a Group E, "no evidence of carcinogenicity for
humans," this risk does not exist.
    5. Determination of safety. Based on these risk assessments, EPA
concludes that there is a reasonable certainty that no harm will result
from aggregate exposure to tebufenozide residues.

E. 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 tebufenozide, EPA considered data from
developmental toxicity studies in the rat and rabbit and a 2-generation
reproduction study in the rat. The developmental toxicity studies are
designed to evaluate adverse effects on the developing organism
resulting from maternal pesticide exposure gestation. Reproduction
studies provide information relating to effects from exposure to the
pesticide on the reproductive capability of mating animals and data on
systemic toxicity.
    FFDCA section 408 provides that EPA shall apply an additional
tenfold margin of safety for infants and children in the case of
threshold effects to account for prenatal and postnatal toxicity and
the completeness of the data base 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 margin of exposure (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

[[Page 37868]]

the standard uncertainty factor (usually 100 for combined inter- and
intraspecies 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.
    Prenatal and postnatal sensitivity. The toxicology data base for
tebufenozide included acceptable developmental toxicity studies in both
rats and rabbits as well as a 2-generation reproductive toxicity study
in rats. The data provided no indication of increased sensitivity of
rats or rabbits to in utero and/or postnatal exposure to tebufenozide.
No maternal or developmental findings were observed in the prenatal
developmental toxicity studies at doses up to 1,000 mg/kg/day in rats
and rabbits. In the 2-generation reproduction studies in rats, effects
occurred at the same or lower treatment levels in the adults as in the
offspring.
    Conclusion. There is a complete toxicity data base for tebufenozide
and exposure data are complete and reasonably accounts for potential
exposures. For the reasons summarized above, EPA concluded that an
additional safety factor is not needed to protect the safety of infants
and children.
    2. Acute risk. Since no acute toxicological endpoints were
established, no acute aggregate risk exists.
    3. Chronic risk. Using the exposure assumptions described in this
unit, EPA has concluded that aggregate exposure to tebufenozide from
food will utilize 73% of the cPAD for infants and children. EPA
generally has no concern for exposures below 100% of the cPAD because
the cPAD 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 tebufenozide in drinking
water, EPA does not expect the aggregate exposure to exceed 100% of the
PAD.
    4. Short- or intermediate-term risk. Short- and intermediate-term
risks are judged to be negligible due to the lack of significant
toxicological effects observed.
    5. Determination of safety. Based on these risk assessments, EPA
concludes that there is a reasonable certainty that no harm will result
to infants and children from aggregate exposure to tebufenozide
residues.

III. Other Considerations

A. Metabolism in Plants and Animals

    The qualitative nature of the residue in plants is adequately
understood based upon acceptable apple, sugar beet, and rice metabolism
studies. EPA has concluded that the residue of regulatory concern is
tebufenozide per se. There are no animal feed items associated with
kiwifruit; consequently, a discussion of potential transfer of
secondary residues to animal commodities is not relevant.

B. Analytical Enforcement Methodology

    The High Pressure Liquid Chromatography using ultra-violet
detection (HPLC/UV) method (TR 34-95-66) used for determining residues
of tebufenozide in/on kiwifruit is adequate for data collection.
Adequate method validation and concurrent method recovery data have
been submitted for this method. The limit of quantitation (LOQ) is 0.02
ppm for residues of tebufenozide in/on kiwifruit.
    The Agency has requested that the petitioner revise the proposed
enforcement method to correct the deficiencies noted during Agency
method validation. Upon completion of the method revisions, the
petitioner will be required to submit a copy suitable for publication
in the Pesticide Analytical Manual, Volume II (PAM II).
    The method may be requested from: Calvin Furlow, PRRIB, IRSD
(7502C), Office of Pesticide Programs, Environmental Protection Agency,
401 M St., SW., Washington, DC 20460. Office location and telephone
number: Rm 101FF, CM #2, 1921 Jefferson Davis Hwy., Arlington, VA,
(703) 305-5229.

C. Magnitude of Residues

    Adequate residue data were provided to support the tolerance for
kiwifruit at 0.5 ppm. There are no animal feed items associated with
kiwifruit; consequently, a discussion of potential transfer of
secondary residues to animal commodities is not relevant. There are no
currently regulated processed food or feed items derived from
kiwifruit; therefore, a discussion of tolerances for processed
commodities is not relevant.

D. International Residue Limits

    A proposed Codex MRL of 0.5 ppm in/on kiwifruit is currently at
Step 3. This is in harmonization with the proposed tolerance sought in
this petition.

E. Rotational Crop Restrictions

    As kiwifruit is a perennial crop, confined and field rotational
crop studies are not required for establishing a tolerance on
kiwifruit.

IV. Conclusion

    Therefore, the tolerance is established for residues of
tebufenozide in/on kiwifruit at 0.5ppm.

V. Objections and Hearing Requests

    The new FFDCA section 408(g) provides essentially the same process
for persons to "object" to a tolerance regulation 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 September 13, 1999, 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 under the "ADDRESSES" section (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
regulation. 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). EPA is authorized to waive any fee requirement
"when in the judgement of the Administrator such a waiver or refund is
equitable and not contrary to the purpose of this subsection." For
additional information regarding tolerance objection fee waivers,
contact James Tompkins, 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: Rm. 239, CM #2, 1921 Jefferson Davis Hwy., Arlington, VA,
(703) 305-5697, tompkins.jim@epa.gov. Requests for waiver of tolerance
objection fees should be sent to James Hollins, Information Resources
and Services Division (7502C), Office of Pesticide Programs,
Environmental Protection Agency, 401 M St., SW., Washington, DC 20460.
    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

[[Page 37869]]

(40 CFR 178.27). A request for a hearing will be granted if the
Administrator determines that the material submitted shows the
following: There is genuine and substantial issue of fact; there is a
reasonable possibility that available evidence identified by the
requestor would, if established, resolve one or more of such issues in
favor of the requestor, taking into account uncontested claims or facts
to the contrary; and resolution of the factual issues in the manner
sought by the requestor would be adequate to justify the action
requested (40 CFR 178.32). Information submitted in connection with an
objection or hearing request may be claimed confidential by marking any
part or all of that information as CBI. Information so marked will not
be disclosed except in accordance with procedures set forth in 40 CFR
part 2. A copy of the information that does not contain CBI must be
submitted for inclusion in the public record. Information not marked
confidential may be disclosed publicly by EPA without prior notice.

VI. Public Record and Electronic Submissions

    EPA has established a record for this regulation under docket
control number [OPP-300886] (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, CM #2,
1921 Jefferson Davis Hwy., Arlington, VA.
    Objections and hearing requests may be sent by e-mail directly to
EPA at:

    opp-docket@epa.gov

    E-mailed objections and hearing requests must be submitted as an
ASCII file avoiding the use of special characters and any form of
encryption.
    The official record for this regulation, as well as the public
version, as described in this unit 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 record which
will also include all comments submitted directly in writing. The
official record is the paper record maintained at the Virginia address
in "ADDRESSES" at the beginning of this document.

VII. Regulatory Assessment Requirements

A. Certain Acts and Executive Orders

    This final rule establishes a tolerance under section 408(d) of the
FFDCA 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) (Public Law 104-4). Nor
does it require any 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 tolerances and exemptions that are established
on the basis of a petition under FFDCA section 408(d), such as the
tolerance in this final rule, do not require the issuance of a proposed
rule, the requirements of the Regulatory Flexibility Act (RFA) (5
U.S.C. 601 et seq.) do not apply. Nevertheless, the Agency 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.

B. Executive Order 12875

    Under Executive Order 12875, entitled Enhancing the
Intergovernmental Partnership (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 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, 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 officials 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.

[[Page 37870]]

VIII. Submission to Congress and the Comptroller General

    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the Agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and 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: June 25, 1999.

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. 321(q), 346a and 371.

    2. In Sec. 180.482, in paragraph (a), by adding alphabetically the
following commodity to the table and adding footnote 1 to the table to
read as follows:

Sec. 180.482  Tebufenozide; tolerances for residues.

    (a)     *    *    *

------------------------------------------------------------------------
                   Commodity                        Parts per million
------------------------------------------------------------------------

                          *    *    *    *    *
Kiwifruit\1\...................................                      0.5

                          *    *    *    *    *
------------------------------------------------------------------------
\1\ There are no U.S. registrations on kiwifruit as of June 15, 1999.

*    *    *    *    *

[FR Doc. 99-17776 Filed 7-13-99; 8:45 am]
BILLING CODE 6560-50-F