[Federal Register Volume 64, Number 139 (Wednesday, July 21, 1999)]
[Rules and Regulations]
[Pages 39060-39068]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-18483]



[[Page 39060]]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-300896; FRL-6092-1]
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.

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SUMMARY: This regulation establishes tolerances for residues of 
tebufenozide in or on pome fruit, apple pomace, cotton and cotton gin 
byproducts and tolerances for the combined residues of tebufenozide and 
the metabolites benzoic acid, 3,5-dimethyl-1-(1,1-dimethylethyl)-2-((4-
carboxymethyl)benzoyl)hydrazide), benzoic acid, 3-hydroxymethyl,5-
methyl-1-(1,1-dimethylethyl)-2-(4-ethylbenzoyl)hydrazide, the stearic 
acid conjugate of benzoic acid, 3-hydroxymethyl,5-methyl-1-(1,1-
dimethylethyl)-2-(4-ethylbenzoyl)hydrazide and benzoic acid, 3-
hydroxymethyl-5-methyl-1-(1,1-dimethylethyl)-2-(4-(1-
hydroxyethyl)benzoyl)hydrazide in or on the meat of cattle, goats, 
hogs, horses, and sheep; the fat of cattle, goats, hogs, horses, and 
sheep; meat byproducts of cattle, goats, hogs, horses, and sheep; and 
milk. Rohm and Haas Company requested these tolerances under the 
Federal Food, Drug, and Cosmetic Act, as amended by the Food Quality 
Protection Act of 1996.

DATES: This regulation is effective July 21, 1999. Objections and 
requests for hearings must be received by EPA on or before September 
20, 1999.

ADDRESSES: Written objections and hearing requests, identified by the 
docket control number, [OPP-300896], 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-300896], 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: [email protected]. Copies of objections and hearing requests 
must be submitted as an ASCII file avoiding the use of special 
characters and any form of encryption. Copies of objections and hearing 
requests will also be accepted on disks in WordPerfect 5.1/6.1 file 
format or ASCII file format. All copies of objections and hearing 
requests in electronic form must be identified by the docket control 
number [OPP-300896]. 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, CM #2, 1921 
Jefferson Davis Hwy., Arlington, VA, (703) 305-6411, 
[email protected].

SUPPLEMENTARY INFORMATION: In the Federal Register of August 19, 1998 
(63 FR 44439) (FRL-6019-6) and February 17, 1999 (64 FR 7883) (FRL-
6060-1), EPA issued notices 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. These notices included a summary of the petition prepared 
by Rohm and Haas Company, the registrant. There were no comments 
received in response to these notices of filing.
    The petitions requested that 40 CFR 180.482 be amended by 
establishing a tolerance for residues of the insecticide tebufenozide, 
in or on pome fruit, apple pomace, cotton, and cotton gin byproducts at 
1.25, 3.0, 1.5, and 30 part per million (ppm) respectively. 
Tebufenozide is a reduced risk pesticide sold under the trade names of 
Confirm 2F and Confirm 70 WSP. Tebufenozide controls beet armyworm, 
cabbage looper, fall armyworm, Southern armyworm, true armyworm, and 
yellowstriped armyworm on cotton. On pome fruit it controls codling 
moth, lesser appleworm, obliquebanded leafroller, tufted apple bud 
moth, eyespotted bud moth, fruitree leafroller, green fruitworm, 
pandemis leafroller, redbanded leafroller, and variegated leafroller.

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 and to make a determination on aggregate exposure, 
consistent with section 408(b)(2), for a tolerance for residues of 
tebufenozide on pome fruit, apple pomace, cotton, and cotton gin 
byproducts at 1.5, 3.0, 1.5, and 30 ppm respectively and tolerances for 
the combined residues of tebufenozide and its metabolites benzoic acid, 
3,5-dimethyl-1-(1,1-dimethylethyl)-2-((4-
carboxymethyl)benzoyl)hydrazide), benzoic acid, 3-hydroxymethyl,5-
methyl-1-(1,1-dimethylethyl)-2-(4-

[[Page 39061]]

ethylbenzoyl)hydrazide, the stearic acid conjugate of benzoic acid, 3-
hydroxymethyl,5-methyl-1-(1,1-dimethylethyl)-2-(4-
ethylbenzoyl)hydrazide and benzoic acid, 3-hydroxymethyl-5-methyl-1-
(1,1-dimethylethyl)-2-(4-(1-hydroxyethyl)benzoyl)hydrazide in or on the 
meat of cattle, goats, hogs, horses, and sheep; the fat of cattle, 
goats, hogs, horses, and sheep; meat byproducts of cattle, goats, hogs, 
horses, and sheep; and milk at 0.08, 0.1, 0.08, and 0.04 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% 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 males and females dogs) based on decreases in red blood cells 
(RBC), hematocrit (HCT), and hemoglobin (HGB), increases in Heinz 
bodies, methemoglobin, mean corpuscuslar 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 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, 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 males and females), 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 males and females) based on decreased body weight on postnatal days 
14 and 21.
    10. Several mutagenicity tests 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 
(UDS) in rat hepatocytes.
    11. The pharmacokinetics and metabolism of tebufenozide were 
studied in females 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; 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

[[Page 39062]]

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 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 males and females bile-duct cannulated rats. Over a 72-hour 
period, biliary excretion accounted for 30% (females) to 34% (males) of 
the administered dose while urinary excretion accounted for equivulant 
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% (females) to 39% (males). The majority of the radioactivity in 
the bile (20% (females) to 24% (males) 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% 
(males) to 70% (females)) 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 (males and/or females). 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-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% active ingredient (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 
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 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, tolerances will be 
established for the residues of tebufenozide in or on pome fruit, apple 
pomace, cotton, and cotton gin byproducts at 1.5, 3.0, 1.5, and 30 ppm 
respectively and tolerances for the combined residues of tebufenozide 
and its metabolites benzoic acid, 3,5-dimethyl-1-(1,1-dimethylethyl)-2-
((4-carboxymethyl)benzoyl)hydrazide), benzoic acid, 3-hydroxymethyl,5-
methyl-1-(1,1-dimethylethyl)-2-(4-ethylbenzoyl)hydrazide, the stearic 
acid conjugate of benzoic acid, 3-hydroxymethyl,5-methyl-1-(1,1-
dimethylethyl)-2-(4-ethylbenzoyl)hydrazide and benzoic acid, 3-
hydroxymethyl-5-methyl-1-(1,1-dimethylethyl)-2-(4-(1-
hydroxyethyl)benzoyl)hydrazide in or on the meat of cattle, goats, 
hogs, horses, and sheep; the fat of cattle, goats, hogs, horses, and 
sheep; meat byproducts of cattle, goats, hogs, horses, and sheep; and 
milk at 0.08, 0.1, 0.08, and 0.04 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 crop 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

[[Page 39063]]

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 section 408(b)(2)(F), 
EPA may require registrants to submit data on PCT.
    Estimates of PCT were used as follows. In all cases the maximum 
estimates were used.

 
------------------------------------------------------------------------
             Crop                   Average              Maximum
------------------------------------------------------------------------
Almonds......................  <1%                                   <1%
Beans/Peas, Dry..............  <0%                                   <1%
Cole Crops...................  <1%                                   <2%
Spinach, Fresh...............  <2%                                   <3%
Spinach, Processed...........  <20%                                 <29%
Sugarcane....................  <3%                                   <5%
Walnuts......................  <10%                                 <16%
------------------------------------------------------------------------

    The following market share data obtained from Rohm and Haas was 
also used:

 
------------------------------------------------------------------------
                      Crop                           Market Share (%)
------------------------------------------------------------------------
Sugarcane......................................                     81.8
Fruiting Vegetables............................                      9.9
Leafy Vegetables...............................                     14.2
Blueberries....................................                       25
------------------------------------------------------------------------


    Where market share information was available, it was used in 
preference over PCT, since it is the larger more conservative number 
and therefore more protective of human health.
    The Agency believes that the three conditions, discussed in section 
408 (b)(2)(F) 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 is 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 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. 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. EPA used the Dietary Exposure 
Evaluation Model (DEEM), which incorporates data from the Continuing 
Survey of Food Intakes by Individuals (CSFII), 1989 to 1992. In 
conducting this exposure assessment, EPA has made very conservative 
assumptions -- 100% of pome fruit and cotton commodities and all other 
commodities having tebufenozide tolerances will contain tebufenozide 
residues and those residues would be at the level of the tolerance, and 
some PCT and market share data for selected commodities -- which result 
in an overestimate of human dietary exposure from food. Thus, in making 
a safety determination for this tolerance, EPA is taking into account 
this conservative exposure assessment. The resulting estimated food 
exposures for the 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 18% of the cPAD. Generally, in the absence of additional 
safety factors, EPA is not concerned with exposures less than 100% of 
the cPAD. Thus, for all populations, the chronic human health risk from 
exposure to tebufenozide in foods is below EPA's level of concern.

 
------------------------------------------------------------------------
                                    ARCfood (mg/kg/
       Population Subgroup               day)                %PAD
------------------------------------------------------------------------
U.S. Population.................  0.001433            8
U.S. Population (autumn season).  0.001461            8
U.S. Population (winter season).  0.001478            8
 Northeast region...............  0.001510            8
Pacific region..................  0.001624            9
Western region..................  0.001576            9
Non-Hispanic Blacks.............  0.001469            8
Non-Hispanic/non-white/non-       0.001709            10
 black).
All infants (< 1 year)..........  0.002109            12
Nursing infants.................  0.000871            5
Non-nursing infants.............  0.002631            15
Children 1-6 yrs................  0.003251            18
Children 7-12 yrs...............  0.001899            11
Females 13+ (nursing)...........  0.001552            9
Males 13-19 yrs.................  0.001139            6
------------------------------------------------------------------------


    The subgroups listed above are: (1) The U.S. population (48 
contiguous States); (2) those for infants and children; (3) the other 
subgroups for which the percentage of the PAD occupied is greater than 
that occupied by the subgroup U.S. population (48 contiguous 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.

[[Page 39064]]

    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 environmental concentrations in water (EECs) 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 lb a.i. 5 applications per year on 
pecans. This application scenario was used to calculate the EEC 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 Dietary Exposure 
Evaluation Model (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 drinking water estimated concentrations 
(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 
are no non-dietary acute, chronic, short- or intermediate-term exposure 
scenarios.
    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 8% of the 
cPAD for the U.S. population. The major identifiable subgroup with the 
highest aggregate exposure is children (1-6 years old) at 18% 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 cPAD.
    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. 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 the standard uncertainty factor (usually 100 for combined 
inter- and intraspecies variability) and not the additional tenfold 
MOE/uncertainty factor when

[[Page 39065]]

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 no more than 18% 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. The modeling data for tebufenozide indicate 
levels less than EPA's DWLOC. 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. The qualitative nature of the residues in animals 
is also adequately understood based on acceptable poultry and ruminant 
metabolism studies. For animals, EPA has concluded that the residues of 
regulatory concern are tebufenozide and its metabolites benzoic acid, 
3,5-dimethyl-1-(1,1-dimethylethyl)-2-((4-
carboxymethyl)benzoyl)hydrazide), benzoic acid, 3-hydroxymethyl,5-
methyl-1-(1,1-dimethylethyl)-2-(4-ethylbenzoyl)hydrazide, the stearic 
acid conjugate of benzoic acid, 3-hydroxymethyl,5-methyl-1-(1,1-
dimethylethyl)-2-(4-ethylbenzoyl)hydrazide and benzoic acid, 3-
hydroxymethyl-5-methyl-1-(1,1-dimethylethyl)-2-(4-(1-
hydroxyethyl)benzoyl)hydrazide.

B. Analytical Enforcement Methodology

     The high pressure liquid chromatography/ultraviolet detection 
(HPLC/UV) or mass spectrometry detection (MS) method, Rohm and Haas 
Method TR 34-96-135, and its earlier versions TR 34-95-154, TR 34-96-
33, and TR 34-97-002 used for determining residues of tebufenozide in/
on cotton matrices from the submitted residue field trials and 
processing study are adequate for collection of residue data. Adequate 
method validation and concurrent method recovery data have been 
submitted for these methods. The limit of quantitation (LOQ) for 
tebufenozide is 0.01 ppm in/on cottonseed, meal and hull. The LOQ for 
tebufenozide is 0.025 ppm in/on refined oil, and 0.10 ppm in/on cotton 
gin byproducts. The reported limit of detection (LOD) for tebufenozide 
is 0.003 ppm for cottonseed, meal and hull, 0.008 ppm for refined oil, 
and 0.03 ppm for cotton gin byproducts.
    The proposed enforcement method (Rohm and Haas Method TR 34-96-135) 
has undergone an adequate Independent Laboratory Validation. As similar 
methods for walnuts and apples have been validated by the Agency's 
Analytical Chemistry Laboratory, further Agency validation of method 
TR-34-96-135 is not required.
    The HPLC/UV methods, Rohm and Haas Methods TR 34-94-38 (the 
original enforcement method designation), 34-95-66, and 34-95-188, each 
versions of the proposed enforcement method for apples and used for 
determining residues of tebufenozide in/on pome fruits, are adequate 
for collection of residue data. Adequate method validation and 
concurrent method recovery data have been submitted for these methods. 
The validated LOQ is 0.02 ppm for residues of tebufenozide in/on pears 
and apples.
    The HPLC/UV Method, Rohm and Haas Method TR 34-96-109 is adequate 
for collecting data on residues of tebufenozide in animal tissues and 
milk. The validated LOQ for tebufenozide in animal tissue and milk are 
0.02 and 0.01 ppm, respectively. The LOQ for each of the metabolites 
studied are as follows: RH-9526 and RH-0282 in milk, 0.01 ppm; RH-2703 
in liver, 0.02 ppm; RH-9886 and RH-0282 in meat 0.02 ppm; RH-9526 in 
fat, 0.02 ppm. The LODs for the analytes are 0.003 ppm in milk and 
0.006 ppm in tissues.
    This method has been adequately radiovalidated using samples from 
the goat metabolism study and has undergone a successful ILV trial. A 
copy of Method 34-96-109 has been forwarded to the Analytical Chemistry 
Branch (ACB) for evaluation as a possible enforcement method.The 
proposed enforcement method has not been subjected to a complete Agency 
method validation at this time. EPA has conducted a preliminary review 
of the method that indicates that it appears to be suitable for 
enforcement purposes pending the outcome of the actual method 
validation. Given that the registrant has provided concurrent 
fortification data to demonstrate that the method is adequate for data 
collection purposes and has provided the Agency with a successful 
Independent Laboratory Validation, coupled with EPA's preliminary 
review, EPA concludes that the methods are suitable as enforcement 
methods to support tolerances associated with a conditional 
registration only. As a condition of the registration, the Agency will 
require a successful method validation and the registrant will be 
required to make any necessary modifications to the method resulting 
from the laboratory validation.
     These methods 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

     The submitted data from 15 tests on cotton depicting residues of 
tebufenozide in/on undelinted cottonseed and cotton gin byproducts

[[Page 39066]]

are adequate. Residues of tebufenozide were 0.02 to 1.43 ppm in/on 27 
samples of undelinted cottonseed, and 1.23 to 30.10 ppm in/on 12 
samples of cotton gin byproducts harvested 13 or 14 days following four 
applications totaling 1.04 lb ai/acre/season (1x proposed rate).
    The available data support the proposed 1.5 ppm tolerance for 
residues of tebufenozide in/on undelinted cottonseed. In addition, the 
available data support the proposed 30.0 ppm tolerance for residues of 
tebufenozide in/on cotton gin byproducts.
    The submitted apple and pear residue data are adequate; the 
petitioner submitted data from 19 tests on apples and pears, 
representative commodities of the pome fruits crop group. Residues of 
tebufenozide were 0.183 to 1.040 ppm in/on apples and pears harvested 
14 or 15 days following the last of six foliar applications of 
tebufenozide (70% WP or 2 lb/gal) at 0.308 lb a.i./acre/application 
(1.85 lb a.i./acre/season; 1x the proposed seasonal rate).
    EPA determined that the crop group tolerance for pome fruit should 
be raised to 1.5 ppm based on the field trial data.
    The submitted cow feeding study is adequate.The proposed 0.05 ppm 
tolerances for residues in kidney, meat, and meat byproducts are not 
adequate. The combined residues of the parent and four metabolites are 
to be regulated in all livestock commodities. For tissues, the sum of 
the LOQs for parent and metabolites is 0.08 ppm. In milk, the combined 
LOQs would be 0.04 ppm. The appropriate tolerances for meat and meat 
byproducts (of cattle, goats, hogs, horses, and sheep) are 0.08 ppm 
(sum of method LOQs), based on the results of the feeding study for 
muscle and liver/kidney, respectively. In the case of fat, a slightly 
higher tolerance of 0.10 ppm is needed. In the case of milk, each 
residue measured in the feeding study was below its LOQ of 0.01 ppm at 
the 0.84x level. A milk tolerance of 0.04 ppm representing the sum of 
all the LOQs is appropriate. Horses need to be added to the tissue 
tolerances.
    The current dietary burden for poultry indicates that finite 
residues are not expected in eggs or poultry at this time.
    Tebufenozide residues do not concentrate in apple juice or cotton 
oil, meal and hulls.

D. International Residue Limits

    Codex MRLs have been established for residues of tebufenozide in/on 
pome fruit (1.0 ppm), husked rice (0.1 ppm), and walnuts (0.05 ppm). 
Tebufenozide is registered in Canada, and a tolerance for residues in/
on apples is established at 1.0 ppm. The U.S. field trial data that 
were submitted in support of the proposed U.S. label do not allow the 
U.S. tolerance of 1.5 ppm to be in harmony with the Codex and Canadian 
levels of 1.0 ppm.
    No Codex MRLs have been established on cotton commdities.

E. Rotational Crop Restrictions

    Since pome fruit crops perennial crops, rotational crop 
restrictions are not required for pome fruit.
    In the case of cotton, EPA has determined that 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, leafy/Brassica (cole) vegetables, fruiting/cucurbit 
vegetables. All other crops cannot 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 pome fruit, apple pomace, cotton, and cotton gin 
byproducts at 1.5, 3.0, 1.5, and 30 ppm respectively and tolerances for 
the combined residues of tebufenozide and its metabolites benzoic acid, 
3,5-dimethyl-1-(1,1-dimethylethyl)-2-((4-
carboxymethyl)benzoyl)hydrazide), benzoic acid, 3-hydroxymethyl,5-
methyl-1-(1,1-dimethylethyl)-2-(4-ethylbenzoyl)hydrazide, the stearic 
acid conjugate of benzoic acid, 3-hydroxymethyl,5-methyl-1-(1,1-
dimethylethyl)-2-(4-ethylbenzoyl)hydrazide and benzoic acid, 3-
hydroxymethyl-5-methyl-1-(1,1-dimethylethyl)-2-(4-(1-
hydroxyethyl)benzoyl)hydrazide in or on the meat of cattle, goats, 
hogs, horses, and sheep; the fat of cattle, goats, hogs, horses, and 
sheep; meat byproducts of cattle, goats, hogs, horses, and sheep; and 
milk at 0.08, 0.1, 0.08, and 0.04 ppm respectively.

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 20, 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, [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 (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.

[[Page 39067]]

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-300896] (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:

     [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) (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 
tolerances in this final rule, do not require the issuance of a 
proposed rule, the requirements of the Regulatory Flexibility Act (RFA) 
(5 U.S.C. 601 et seq.) do not apply. Nevertheless, the Agency 
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.

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).


[[Page 39068]]



List of Subjects in 40 CFR Part 180

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

    Dated: July 9, 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, paragraph (a) is amended by redesignating the 
introductory text to paragraph (a) as paragraph (a)(1); by adding 
alphabetically four commodities to the table in newly designated 
paragraph (a)(1); and adding paragraph (a)(2) to read as follows:

Sec. 180.482  Tebufenozide; tolerances for residues.

    (a) General. (1)  *  *  *

 
------------------------------------------------------------------------
                   Commodity                        Parts per million
------------------------------------------------------------------------
 
                          *    *    *    *    *
Apple pomace...................................                      3.0
Cotton.........................................                      1.5
Cotton, gin byproducts.........................                       30
 
                          *    *    *    *    *
Pome Fruit.....................................                      1.5
 
                          *    *    *    *    *
------------------------------------------------------------------------


    (2) Tolerances are established for the combined residues of 
tebufenozide and its metabolites benzoic acid, 3,5-dimethyl-1-(1,1-
dimethylethyl)-2-((4-carboxymethyl)benzoyl)hydrazide), benzoic acid, 3-
hydroxymethyl,5-methyl-1-(1,1-dimethylethyl)-2-(4-
ethylbenzoyl)hydrazide, the stearic acid conjugate of benzoic acid, 3-
hydroxymethyl,5-methyl-1-(1,1-dimethylethyl)-2-(4-
ethylbenzoyl)hydrazide and benzoic acid, 3-hydroxymethyl-5-methyl-1-
(1,1-dimethylethyl)-2-(4-(1-hydroxyethyl)benzoyl)hydrazide.

 
------------------------------------------------------------------------
                   Commodity                        Parts per million
------------------------------------------------------------------------
Fat of cattle, goats, hogs, horses, and sheep..                      0.1
Meat of cattle, goats, hogs, horses and sheep..                     0.08
Meat byproducts of cattle, goats, hogs, horses                      0.08
 and sheep.....................................
Milk...........................................                     0.04
------------------------------------------------------------------------

*    *    *    *    *

[FR Doc. 99-18483 Filed 7-20-99; 8:45 am]
BILLING CODE 6560-50-F