[Federal Register Volume 64, Number 71 (Wednesday, April 14, 1999)]
[Rules and Regulations]
[Pages 18339-18346]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-9060]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-300839; FRL-6073-9]
RIN 2070-AB78


Tebufenozide; Benzoic Acid, 3,5-dimethyl-1-(1,1-dimethylethyl)-2-
(4-ethylbenzoyl) hyrazide; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes a tolerance for residues of 
tebufenozide in or on Leafy and Brassica(cole) Vegetables and Fruiting 
Vegetables. Rohm and Haas Company requested these tolerance under the 
Federal Food, Drug, and Cosmetic Act, as amended by the Food Quality 
Protection Act of 1996.

DATES: This regulation is effective April 14, 1999. Objections and 
requests for hearings must be received by EPA on or before June 14, 
1999.
ADDRESSES: Written objections and hearing requests, identified by the 
docket control number, [OPP-300839], 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 withthe Hearing Clerk identified by the docket 
control number, [OPP-300839], 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, 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: [email protected]. Copies of objections and hearing requests 
must be submitted as an ASCII file avoiding the use of special 
characters and any form of encryption. Copies of objections and hearing 
requests will also be accepted on disks in WordPerfect 5.1/6.1 file 
format or ASCII file format. All copies of objections and hearing 
requests in

[[Page 18340]]

electronic form must be identified by the docket control number [OPP-
300839]. 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 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, Crystal Mall 
#2, 1921 Jefferson Davis Hwy., Arlington, VA, (703) 305-6411, 
[email protected].

SUPPLEMENTARY INFORMATION: In the Federal Register of February 18, 1999 
(64 FR 8090) (FRL-6059-9), 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) (Pub. L. 104-
170) announcing the filing of a pesticide petition (PP 7F4824) for 
tolerances 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 petitions requested that 40 CFR 180.482 be amended by 
establishing tolerances for residues of the insecticide tebufenozide, 
in or on leafy greens crop subgroup, leaf petioles crop subgroup, head 
and stem Brassica crop subgroup, leafy Brassica Greens crop subgroup 
and fruiting vegetables(except cucurbits) at 10.0, 2.0, 5.0, 10.0, and 
1.0 part per million (ppm) respectively.

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) hydride and to make a determination on aggregate 
exposure, consistent with section 408(b)(2), for a tolerance for 
residues of tebufenozide on leafy greens crop subgroup, leaf petioles 
crop subgroup, head and stem Brassica crop subgroup, leafy Brassica 
Greens crop subgroup and fruiting vegetables (except) cucurbits) at 
10.0, 2.0, 5.0, 10.0. and 1.0 ppm. EPA's assessment of the dietary 
exposures and risks associated with establishing the tolerance follows.

A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered its 
validity, completeness, and reliability as well as the relationship of 
the results of the studies to human risk. EPA has also considered 
available information concerning the variability of the sensitivities 
of major identifiable subgroups of consumers, including infants and 
children. The nature of the toxic effects caused by tebufenozide, 
benzoic acid, 3,5-dimethyl-1-(1,1-dimethylethyl)-2-(4-dimethylbenzoyl) 
hyrazide 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 
milligram/kilogram (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% 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 (HTD) 1,000 mg/kg/ during 
the 21 day study. Based on these results, the no-observed effect level 
(NOAEL) for systemic toxicity and dermal irritation in both sexes is 
1,000 mg/kg/day HDT. A lowest-observable-effect level (LOAEL) for 
systemic toxicity and dermal irritation was not established.
    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 RBC, HCT, and HGB, 
increases in Heinz bodies, methemoglobin, MCV, 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).
    An 18-month mouse carcinogenicity study with no carcinogenicity 
observed at dosage levels up to and including 1,000 ppm.
    A 2-year rat carcinogenicity 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).
    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 
milligrams/kilogram/day (mg/kg/day) and a dose volume of 10 ml/kg. 
There was no evidence of maternal or developmental toxicity; the 
maternal and developmental toxicity NOAEL was 1,000 mg/kg/day.
    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.
    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/

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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, 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).
    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.
    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 CHO cells, a CHO/HGPRT assay, a reverse mutation 
assay with E. Coli, and an unscheduled DNA synthesis assay (UDS) in rat 
hepatocytes.
    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 one of three 
positions (A-ring, B-ring or N-butylcarbon). The extent of absorption 
was not established. The majority of the radiolabeled material was 
eliminated or excreted in the feces within 48 hours 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 three 
benzyl carbons, two methyl groups on the Bring 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.
    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 to 34% male of the 
administered dose while urinary excretion accounted for  5% 
of the administered dose and the carcass accounted for <0.5% of the 
administered dose for both male and female. Thus systemic absorption 
(percent of dose recovered in the bile, urine and carcass was 35% 
female to 39% male. The majority of the radioactivity in the bile (20% 
female to 24% male 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% (male) to 70% (female) 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 (male and/or female). 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  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-term toxicity. 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 (MRID 42991507). The HIARC 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 
either rat or

[[Page 18342]]

rabbit studies. This risk is considered to be negligible.
    3. Chronic toxicity. EPA has established the Reference Dose (RfD) 
for tebufenozide, benzoic acid, 3,5-dimethyl-1-(1,1-dimethylethyl)-2-
(4-ethylbenzoyl) hydrazide at 0.018 mg/kg/day. This 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 10 x factor to protect children and infants (as required by 
FQPA) should be removed. Therefore, the RfD remains the same at: 0.018 
mg/kg/day. An UF of 100 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 tolerances will be 
established for the residues of tebufenozide in or on the raw 
agricultural commodities: leafy greens crop subgroup, leaf petioles 
crop subgroup, head and stem Brassica crop subgroup, leafy Brassica 
greens crop subgroup and fruiting vegetables(except cucurbits) at 10.0, 
2.0, 5.0, 10.0 and 1.0 ppm respectively. 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 percent of crop treated 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 percent crop treated 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 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 
negligible.
    ii. Chronic exposure and risk. The RfD used for the chronic dietary 
analysis is 0.018 mg/kg/day. In conducting this exposure assessment, 
HED has made very conservative assumptions -- 100% of Brassica (cole) 
and leafy vegetables and fruiting vegetables and all other commodities 
having tebufenozide tolerances will contain tebufenozide residues and 
those residues would be at the level of the tolerance, and some percent 
crop treated (%CT) data for selected commodities -- which result in an 
overestimate of human dietary exposure. Previous chronic tebufenozide 
analyses conducted for Section 18 actions included %CT data on spinach 
and cole crops. These values were reset to 100% CT as a result of this 
petition for permanent tolerances. Thus, in making a safety 
determination for this tolerance, HED is taking into account this 
conservative exposure assessment.
    With Brassica (cole) and leafy vegetables and fruiting vegetables 
as new tolerances, the existing tebufenozide tolerances (published and 
including the necessary Section 18 tolerances) result in a Anticipated 
Residue Contribution (ARC) that is equivalent to the following 
percentages of the RfD:


------------------------------------------------------------------------
                    Population Subgroup                          %RfD
------------------------------------------------------------------------
U.S. Population - 48 States                                           30
All Infants (<1 year)                                                 29
Nursing Infants (<1 year)                                             20
Non-Nursing Infants (<1 year)                                         33
Children (1-6 years)                                                  44
Children (7-12 years)                                                 35
U.S. Population - Spring Season                                       30
U.S. Population - Winter Season                                       30
Northeast Region                                                      31
Weastern Region                                                       33
Pacific Region                                                        34
Non-Hispanic Blacks                                                   32
Non-Hispanic Other Than Black or White                                36
Females (13+/ nursing)                                                32
Males (20+ years)                                                     26
------------------------------------------------------------------------

    The subgroups listed above are: (1) the U.S. population (48 
States); (2) those for infants and children; (3) the other

[[Page 18343]]

subgroups for which the percentage of the RfD occupied is greater than 
that occupied by the subgroup U.S. population (48 States); and, (4) 
other population subgroups of particular regulatory interest.
    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 is moderately persistent to persistent and 
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. Therefore, potential residue levels 
for drinking water exposure were calculated using Generic Expected 
Environmental Concentration (GENEEC) (surface water) and Screening 
Concentration In Ground Water (SCI-GROW) (ground water) for the human 
health risk assessment. Due to the wide range of aerobic soil half-life 
(t1/2) values, GENEEC and SCI-GROW were run based on aerobic 
half-lives of 66 (California Loam) and 729 (worst case soil with low 
microbial activity) days. Because of the wide range of half-life values 
a range of potential exposure values were calculated. In each case the 
worst case upper bound exposure limits were then compared to 
appropriate chronic water levels of concern (DWLOC). In each case the 
calculated exposures based on model data were below the DWLOC.
    3. From non-dietary exposure. Tebufenozide is not currently 
registered for use on any residential non-food sites. Therefore there 
is no chronic, short- or intermediate-term exposure scenario.
    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.''
    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 ARC exposure assumptions described in 
this unit, EPA has concluded that aggregate exposure to tebufenozide 
from food will utilize 30% of the RfD for the U.S. population. The 
major identifiable subgroup with the highest aggregate exposure is 
children (1-6 years old) at 44 percent of the RfD 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 OPP's DWLOC. 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. 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 RfD.
    3. Short- and intermediate-term risk. Short- and intermediate-term 
aggregate exposure takes into account chronic dietary food and water 
(considered to be a background exposure level) plus indoor and outdoor 
residential exposure. Since 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 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 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 the standard uncertainty factor (usually 100 for combined inter- 
and intra-species variability) and not the additional tenfold MOE/
uncertainty factor when EPA has a complete data base under existing 
guidelines and when the severity of the effect in infants or children 
or the potency or unusual toxic properties of a compound do not raise 
concerns regarding the adequacy of the standard MOE/safety factor.
    ii. Developmental toxicity studies. Developmental toxicity studies 
showed no increased sensitivity in fetuses as compared to maternal 
animals following in utero exposures in rats and rabbits.
    iii. Reproductive toxicity study. Multi-generation reproduction 
toxicity studies in rats showed no increased sensitivity in pups as 
compared to adults and offsprings.
    iv. Pre- and post-natal 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

[[Page 18344]]

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.
    v. Conclusion. There is a complete toxicity database for 
tebufenozide and exposure data is complete and reasonably accounts for 
potential exposures.
    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 44% 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. Despite the potential for exposure to tebufenozide in drinking 
water and from non-dietary, non-occupational exposure, EPA does not 
expect the aggregate exposure to exceed 100% of the RfD.
    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 nature of the residues of tebufenozide in/on plants is 
adequately understood. The residue of concern for both regulatory 
(tolerance expression) and risk assessment purposes is the parent 
compound, tebufenozide per se. Since there are no animal feed items 
associated with leafy and Brassica (cole) leafy vegetables and fruiting 
vegetables, a discussion of the qualitative nature of the residue in 
animals is not germane to this action.

B. Analytical Enforcement Methodology

    The HPLC/UV (designated as TR 34-95-66, TR 34-93-119 and TR-34-94-
41 all virtually identical) method used for determining residues of 
tebufenozide in/on leafy and Brassica (cole) leafy vegetables and 
fruiting vegetables (except cucurbits) is adequate for collection of 
residue data. Adequate method validation and concurrent method recovery 
data have been submitted for this method. The validated limit of 
quantitation (LOQ) and limit of detection (LOD) are 0.02 ppm and 0.006 
ppm, respectively, for residues of tebufenozide in/on tomatoes, tomato 
processed commodities, and peppers. The LOQ is 0.01 ppm for residues of 
tebufenozide in/on lettuce, spinach, cabbage, and mustard greens, and 
the LOQ for celery is 0.05 ppm. The LOD is 0.003 ppm for all leafy 
vegetable matrices tested.
    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, Crystal Mall #2, 1921 Jefferson Davis Hwy., 
Arlington, VA, (703) 305-5229.

C. Magnitude of Residues

    Adequate residue data were provided to support the tolerances for 
leafy greens crop subgroup at 10.0 ppm, leaf petioles crop subgroup at 
2.0 ppm, head and stem Brassica crop subgroup at 5.0 ppm, leafy 
Brassica greens crop subgroup at 10.0 ppm and fruiting vegetables 
(except cucurbits) at 1.0 ppm. There are no currently regulated 
processed food or feed items derived from Brassica (cole) and leafy 
vegetables and fruiting vegetables. Since there are no animal feed 
items associated with Brassica (cole) and leafy vegetables and fruiting 
vegetables, no secondary residues in animals are expected. There are no 
food handling uses for tebufenozide.

D. International Residue Limits

    There are currently no CODEX listings for tebufenozide residues in 
or on the commodities subject to todays action, therefore there are no 
harmonization issues for these crops.

E. Rotational Crop Restrictions

    Crops which the label allows to be treated directly can be planted 
at any time. The following crops can be planted 30 days after 
application: root/tuber/bulb vegetables and cucurbits. All other crops 
can not be planted within 12 months of application. The latter would 
include legume vegetables, cereal grains, grasses and non-grass animal 
feeds.

IV. Conclusion

    Therefore, the tolerance is established for residues of 
tebufenozide in leafy greens crop subgroup, leaf petioles crop 
subgroup, head and stem Brassica crop subgroup, leafy Brassica greens 
crop subgroup and fruiting vegetables (Except cucurbits) at 10.0, 2.0, 
5.0, 10.0 and 1.0 ppm.

V. Objections and Hearing Requests

    The new FFDCA section 408(g) provides essentially the same process 
for persons to ``object'' to a tolerance regulation 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 June 14, 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, Crystal Mall #2, 1921Jefferson Davis Hwy., Arlington, 
VA, (703) 305-5697, [email protected]. 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 18345]]

(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-300839] (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.
    Objections and hearing requests may be sent by e-mail directly to 
EPA at:
    [email protected].


    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) (Pub. L. 104-4). Nor does 
it require any prior consultation as specficed 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 tolerances and exemptions that are established 
on the basis of a petition under FFDCA section 408(d), such as the 
tolerance/exemption 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

[[Page 18346]]

section 3(b) of Executive Order 13084 do not apply to this rule.

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: March 30, 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 alphabetically adding the 
following commodities to the table:

Sec.  180.482  Tebufenozide; tolerances for residues.

    (a) *    *    *


 
------------------------------------------------------------------------
                 Commodity                        Parts per million
------------------------------------------------------------------------
 
               *      *      *      *      *      *      *
Fruiting Vegetables (Except cucurbits)....  1.0
Head and stem Brassica crop subgroup......  5.0
Leafy Brassica greens crop subgroup.......  10.0
Leafy greens crop subgroup................  10.0
Leaf petioles crop subgroup...............  2.0
 
               *      *      *      *      *      *      *
------------------------------------------------------------------------

*    *    *    *    *

[FR Doc. 99-9060 Filed 4-13-99; 8:45 am]
BILLING CODE 6560-50-F