[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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/
[[Page 18341]]
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