Tebufenozide; Pesticide Tolerances for Emergency Exemptions

Note: EPA no longer updates this information, but it may be useful as a reference or resource.
 [Federal Register: March 17, 1999 (Volume 64, Number 51)]
[Rules and Regulations]               
[Page 13088-13094]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr17mr99-13]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-300799; FRL-6065-2]
RIN 2070-AB78

 
Tebufenozide; Pesticide Tolerances for Emergency Exemptions

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes time-limited tolerances for 
residues of tebufenozide in or on lychee and longan. This action is in 
response to EPA's granting of an emergency exemption under section 18 
of the Federal Insecticide, Fungicide, and Rodenticide Act authorizing 
use of the pesticide tebufenozide on lychee and longan. This regulation 
establishes a maximum permissible level for residues of benzoic acid, 
3,5-dimethyl-1-(1,1-dimethylethyl)-2-(4-ethylbenzoyl)hydrazide in these 
food commodities pursuant to section 408(l)(6) of the Federal Food, 
Drug, and Cosmetic Act, as amended by the Food Quality Protection Act 
of 1996. The tolerances will expire and are revoked on December 31, 
2001.


[[Page 13089]]


DATES: This regulation is effective March 17, 1999. Objections and 
requests for hearings must be received by EPA on or before May 17, 
1999.
ADDRESSES: Written objections and hearing requests, identified by the 
docket control number [OPP-300799], 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-300799], 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 also be submitted electronically by sending electronic mail 
(e-mail) to: opp-docket@epa.gov. Copies of electronic 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 
or ASCII file format. All copies of electronic objections and hearing 
requests must be identified by the docket control number [OPP-300799]. 
No Confidential Business Information (CBI) should be submitted through 
e-mail. Copies of electronic objections and hearing requests on this 
rule may be filed online at many Federal Depository Libraries.

FOR FURTHER INFORMATION CONTACT: By mail: Barbara Madden, 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. 284, CM #2, 1921 
Jefferson Davis Hwy., Arlington, VA, (703) 305-6463, 
Madden.Barbara@epa.gov.

SUPPLEMENTARY INFORMATION: EPA, on its own initiative, pursuant to 
sections 408 and (l)(6) of the Federal Food, Drug, and Cosmetic Act 
(FFDCA), 21 U.S.C. 346a and (l)(6), is establishing tolerances for 
residues of the insecticide tebufenozide, in or on lychee and longan at 
1.0 part per million (ppm). These tolerances will expire and are 
revoked on December 31, 2001. EPA will publish a document in the 
Federal Register to remove the revoked tolerance from the Code of 
Federal Regulations.

I. Background and Statutory Findings

    The Food Quality Protection Act of 1996 (FQPA) (Pub. L. 104-170) 
was signed into law August 3, 1996. FQPA amends both the Federal Food, 
Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 301 et seq., and the Federal 
Insecticide, Fungicide, and Rodenticide Act (FIFRA), 7 U.S.C. 136 et 
seq. The FQPA amendments went into effect immediately. Among other 
things, FQPA amends FFDCA to bring all EPA pesticide tolerance-setting 
activities under a new section 408 with a new safety standard and new 
procedures. These activities are described in this preamble and 
discussed in greater detail in the final rule establishing the time-
limited tolerance associated with the emergency exemption for use of 
propiconazole on sorghum (61 FR 58135, November 13, 1996) (FRL-5572-9).
    New section 408(b)(2)(A)(i) of the FFDCA allows EPA to establish a 
tolerance (the legal limit for a pesticide chemical residue in or on a 
food) only if EPA determines that the tolerance is ``safe.'' Section 
408(b)(2)(A)(ii) defines ``safe'' to mean that ``there is a reasonable 
certainty that no harm will result from aggregate exposure to the 
pesticide chemical residue, including all anticipated dietary exposures 
and all other exposures for which there is reliable information.'' This 
includes exposure through drinking water and in residential settings, 
but does not include occupational exposure. Section 408(b)(2)(C) 
requires EPA to give special consideration to exposure of infants and 
children to the pesticide chemical residue in establishing a tolerance 
and to ``ensure that there is a reasonable certainty that no harm will 
result to infants and children from aggregate exposure to the pesticide 
chemical residue. . . .''
    Section 18 of FIFRA authorizes EPA to exempt any Federal or State 
agency from any provision of FIFRA, if EPA determines that ``emergency 
conditions exist which require such exemption.'' This provision was not 
amended by FQPA. EPA has established regulations governing such 
emergency exemptions in 40 CFR part 166.
    Section 408(l)(6) of the FFDCA requires EPA to establish a time-
limited tolerance or exemption from the requirement for a tolerance for 
pesticide chemical residues in food that will result from the use of a 
pesticide under an emergency exemption granted by EPA under section 18 
of FIFRA. Such tolerances can be established without providing notice 
or period for public comment.
    Because decisions on section 18-related tolerances must proceed 
before EPA reaches closure on several policy issues relating to 
interpretation and implementation of the FQPA, EPA does not intend for 
its actions on such tolerances to set binding precedents for the 
application of section 408 and the new safety standard to other 
tolerances and exemptions.

II. Emergency Exemption for Tebufenozide on Lychee and Longan and 
FFDCA Tolerances

    There are approximately 611 and 410 acres of commercial lychee and 
longan grown in Florida, respectively. Lychee and longan have been 
relatively pest-free in Florida up until 1998. However, during the mid-
1990's lychee webworm was introduced into Florida. During the 1998 
growing season up to 80-90% of the lychee trees and 50-60% of the 
longan trees beared little to no marketable fruit due to lychee webworm 
infestation. There are very few pesticides registered for use on lychee 
and longan and none have proven effective in controlling the lychee 
webworm. Therefore, growers are left with no viable measures to control 
the lychee webworm. EPA has authorized under FIFRA section 18 the use 
of tebufenozide on lychee and longan for control of lychee webworms in 
Florida. After having reviewed the submission, EPA concurs that 
emergency conditions exist for this state.
    As part of its assessment of this emergency exemption, EPA assessed 
the potential risks presented by residues of tebufenozide in or on 
lychee and longan. In doing so, EPA considered the safety standard in 
FFDCA section 408(b)(2), and EPA decided that the necessary tolerance 
under FFDCA section 408(l)(6) would be consistent with the safety 
standard and with FIFRA section 18. Consistent with the need to move 
quickly on the emergency exemption in order to address an urgent non-
routine situation and to ensure that the resulting food is safe and 
lawful, EPA is issuing this tolerance without notice and opportunity 
for public comment under section 408(e), as provided in section 
408(l)(6). Although this tolerance will expire and is revoked on 
December 31, 2001, under FFDCA section 408(l)(5), residues of the 
pesticide not in excess of the amounts

[[Page 13090]]

specified in the tolerance remaining in or on lychee and longan after 
that date will not be unlawful, provided the pesticide is applied in a 
manner that was lawful under FIFRA, and the residues do not exceed a 
level that was authorized by this tolerance at the time of that 
application. EPA will take action to revoke this tolerance earlier if 
any experience with, scientific data on, or other relevant information 
on this pesticide indicate that the residues are not safe.
    Because this tolerance is being approved under emergency conditions 
EPA has not made any decisions about whether tebufenozide meets EPA's 
registration requirements for use on lychee and longan or whether a 
permanent tolerance for this use would be appropriate. Under these 
circumstances, EPA does not believe that this tolerance serves as a 
basis for registration of tebufenozide by a State for special local 
needs under FIFRA section 24(c). Nor does this tolerance serve as the 
basis for any State other than Florida to use this pesticide on this 
crop under section 18 of FIFRA without following all provisions of 
EPA's regulations implementing section 18 as identified in 40 CFR part 
166. For additional information regarding the emergency exemption for 
tebufenozide, contact the Agency's Registration Division at the address 
provided under the ``ADDRESSES'' section.

III. Aggregate Risk Assessment and Determination of Safety

    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) .
    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 time-limited tolerance for 
residues of tebufenozide on lychee and longan at 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 are 
discussed in this unit.

B. Toxicological Endpoint

    1. Acute toxicity. No toxicological endpoint has been identified 
for acute toxicity. Toxicity observed in oral toxicity studies were not 
attributable to a single dose (exposure). No neurological or systemic 
toxicity was observed in rats given a single oral administration of 
tebufenozide at 0, 500, 1,000 or 2,000 milligrams/kilogram/day (mg/kg/
day). 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.
    2. Short - and intermediate - term toxicity. No toxicological 
endpoints have been identified for short- and intermediate-term 
toxicity. No dermal or systemic toxicity was seen in rats administered 
15 dermal applications at 1,000 mg/kg/day (limit dose) over 21 days 
with either technical tebufenozide or 23% active ingredient 
formulation. Despite hematological effects seen in the dog study, 
similar effects were not seen in these 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.
    3. Chronic toxicity. EPA has established the RfD for tebufenozide 
at 0.018 mg/kg/day. This RfD is based on the no observable adverse 
effect level (NOAEL) of 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 the lowest 
observable adverse effect level (LOAEL) of 8.7 mg/kg/day. An 
uncertainty factor of 100 (10X for inter-species extrapolation and 10X 
for intra-species variability) was applied to the NOAEL of 1.8 mg/kg/
day to calculate the RfD of 0.018 mg/kg/day. EPA has determined that 
the 10X factor to account for enhanced susceptibility of infants and 
children (as required by FQPA) can be removed. This determination is 
based on the results of reproductive and developmental toxicity 
studies. No evidence of additional sensitivity to young rats or rabbits 
was observed following pre- or postnatal exposure to tebufenozide.
    4. Carcinogenicity. Tebufenozide is classified as Group E (no 
evidence of carcinogenicity in humans).

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. Tolerances, in support of registrations, 
currently exist for residues of tebufenozide on apples and walnuts. 
Additionally, time-limited tolerances associated with emergency 
exemptions have been established for cotton, eggs, leafy vegetables, 
milk, pears, peanuts, pecans, peppers, rice, sugar beet, sugarcane, 
sweet potatoes, turnip tops and livestock commodities of cattle, goats, 
hogs, horses, poultry and sheep. Risk assessments were conducted by EPA 
to assess dietary exposures and risks from tebufenozide as follows:
    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 or one day exposure. 
Therefore, no toxicological endpoint was identified for acute toxicity 
and no acute dietary risk assessment is needed.
    ii. Chronic exposure and risk. The Agency conducted a chronic 
dietary exposure analysis and risk assessment. The chronic analysis for 
tebufenozide used a RfD of 0.018 mg/kg/day. The analysis evaluated 
individual food consumption as reported by respondents in the USDA 
1989-92 Continuing Surveys of Food Intake by Individuals and 
accumulates exposure to the chemical for each commodity. Tolerance 
level residues and some percent crop treated (%CT) assumptions were 
made for the proposed commodities to estimate the Anticipated Residue 
Concentration (ARC) for the general population and subgroups of 
interest. Since the FQPA safety factor has been removed for all 
population subgroups, the percent RfD that would exceed the Agency 
level of concern would be 100%. The existing tebufenozide tolerances 
(published, pending, and including the necessary Section 18 
tolerance(s)) result in a ARC that is equivalent to percentages of the 
RfD below 100% for all subgroups i.e., U.S. population, 12% and non-
nursing infants (<1 year old), the most highly exposed subgroup, 25%.
    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

[[Page 13091]]

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 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: almonds, <1%; apples, 
2%; dry beans and peas, 1%; fresh cabbage, 3%; cole crops, 2%; cotton, 
4%; pears, <5; fresh spinach, 3%; processed spinach, 29%; sugarcane, 
5%; and walnuts, 16%.
    The Agency believes that the three conditions, discussed in section 
408 (b)(2)(F) in this unit concerning the Agency's responsibilities in 
assessing chronic dietary risk findings, have been met. The PCT 
estimates are derived from Federal and private market survey data, 
which are reliable and have a valid basis. Typically, a range of 
estimates are supplied and the upper end of this range is assumed for 
the exposure assessment. By using this upper end estimate of the PCT, 
the Agency is reasonably certain that the percentage of the food 
treated is not likely to be underestimated. The regional consumption 
information and consumption information for significant subpopulations 
is taken into account through EPA's computer-based model for evaluating 
the exposure of significant subpopulations including several regional 
groups. Use of this consumption information in EPA's risk assessment 
process ensures that EPA's exposure estimate does not understate 
exposure for any significant subpopulation group and allows the Agency 
to be reasonably certain that no regional population is exposed to 
residue levels higher than those estimated by the Agency. Other than 
the data available through national food consumption surveys, EPA does 
not have available information on the regional consumption of food to 
which tebufenozide may be applied in a particular area.
    2. From drinking water. The Agency lacks sufficient water-related 
exposure data to complete a comprehensive drinking water exposure 
analysis and risk assessment for tebufenozide. Because the Agency does 
not have comprehensive and reliable monitoring data, drinking water 
concentration estimates must be made by reliance on some sort of 
simulation or modeling. To date, there are no validated modeling 
approaches for reliably predicting pesticide levels in drinking water. 
The Agency is currently relying on GENEEC and PRZM/EXAMS for surface 
water, which are used to produce estimates of pesticide concentrations 
in a farm pond and SCI-GROW, which predicts pesticide concentrations in 
groundwater. None of these models include consideration of the impact 
processing of raw water for distribution as drinking water would likely 
have on the removal of pesticides from the source water. The primary 
use of these models by the Agency at this stage is to provide a coarse 
screen for sorting out pesticides for which it is highly unlikely that 
drinking water concentrations would ever exceed human health levels of 
concern. For the proposed uses, based on the GENEEC and SCI-GROW models 
the chronic drinking water concentration value are estimated to be 29 
parts per billion (ppb) for surface water and 1 pbb for ground water.
    In the absence of monitoring data for pesticides, drinking water 
levels of comparison (DWLOCs) are calculated and used as a point of 
comparison against the model estimates of a pesticide's concentration 
in water. DWLOCs are theoretical upper limits on a pesticide's 
concentration in drinking water in light of total aggregate exposure to 
a pesticide in food, drinking water, and residential uses. A DWLOC will 
vary depending on the toxic endpoint, with drinking water consumption, 
and body weights. Different populations will have different DWLOCs. 
DWLOCs are used in the risk assessment process as a surrogate measure 
of potential exposure associated with pesticide exposure through 
drinking water. DWLOC values are not regulatory standards for drinking 
water. Since DWLOCs address total aggregate exposure to tebufenozide 
they are further discussed in the aggregate risk sections below.
    3. From non-dietary exposure. Tebufenozide is not registered on any 
use sites which would result in non-dietary, non-occupational exposure. 
Therefore, EPA expects only dietary and occupational exposure from the 
use of tebufenozide.
    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 more 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. As discussed above, no toxicological endpoint was 
identified for acute toxicity. Therefore, no acute aggregate risk 
assessment is needed.
    2. Chronic risk. Using the ARC exposure assumptions described 
above, EPA has concluded that aggregate exposure to tebufenozide from 
food will utilize 12% of the RfD for the U.S. population. The major 
identifiable subgroup with the highest aggregate exposure, non-nursing 
infants (<1 year old) (discussed below) will utilize 25% of the RfD. 
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, after calculating DWLOCs (560 ppb) and comparing them 
to conservative model estimates of concentrations of tebufenozide in 
surface and ground water (29 ppb and 1 ppb, respectively), 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. Tebufenozide is not registered on any use sites 
which would result in non-dietary, non-occupational exposure. Therefore 
no short- and intermediate-

[[Page 13092]]

term aggregate risk assessments are needed.
    4. Aggregate cancer risk for U.S. population. Tebufenozide is 
classified as Group E (no evidence of carcinogenicity in humans).
    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 during gestation. 
Reproduction studies provide information relating to effects from 
exposure to the pesticide on the reproductive capability of mating 
animals and data on systemic toxicity.
    FFDCA section 408 provides that EPA shall apply an additional 
tenfold margin of safety for infants and children in the case of 
threshold effects to account for pre-and post-natal toxicity and the 
completeness of the database unless EPA determines that a different 
margin of safety will be safe for infants and children. Margins of 
safety are incorporated into EPA risk assessments either directly 
through use of a 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 MOE and uncertainty factor (usually 100 for combined 
inter- and intra-species variability) and not the additional tenfold 
MOE/uncertainty factor when EPA has a complete data base under existing 
guidelines and when the severity of the effect in infants or children 
or the potency or unusual toxic properties of a compound do not raise 
concerns regarding the adequacy of the standard MOE/safety factor.
    ii. Developmental toxicity studies. In prenatal developmental 
toxicity studies in rats and rabbits, there was no evidence of maternal 
or developmental toxicity; the maternal and developmental NOAELS were 
1,000 mg/kg/day (highest dose tested).
    iii. Reproductive toxicity study. In 2-generation reproduction 
studies in rats, toxicity to the fetuses/offspring, when observed, 
occurred at equivalent or higher doses than in the maternal/parental 
animals.
    iv. Pre- and post-natal sensitivity. 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.
    v. Conclusion. There is a complete toxicity database for 
tebufenozide and exposure data is complete or is estimated based on 
data that reasonably accounts for potential exposures. Data provided no 
indication of increased sensitivity of rats or rabbits to in utero and/
or postnatal exposure to tebufenozide. Based on this, EPA concludes 
that reliable data support the use of the standard 100-fold uncertainty 
factor, and that an additional uncertainty factor is not needed to 
protect the safety of infants and children.
    2. Acute risk. No toxicological endpoint was identified for acute 
toxicity. Therefore, no acute aggregate risk assessment is needed.
    3. Chronic risk. Using the exposure assumptions described above, 
EPA has concluded that aggregate exposure to tebufenozide from food 
will utilize 25% of the RfD for infants and 19% of the RfD for 
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, after calculating DWLOCs (140 ppb) and 
comparing them to conservative model estimates of concentrations of 
tebufenozide in surface and ground water (29 ppb and 1 ppb, 
respectively), EPA does not expect the aggregate exposure to exceed 
100% of the RfD.
    4. Short- or intermediate-term risk. Tebufenozide is not registered 
on any use sites which would result in non-dietary, non-occupational 
exposure. Therefore no short- and intermediate-term aggregate risk 
assessments are needed.
    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.

IV. Other Considerations

A. Metabolism In Plants and Animals

    Residue of concern in plants is adequately understood and is 
tebufenozide per se. Residues of concern in animals are not adequately 
understood. Studies to address residues of concern for animals are 
currently under Agency review. For the purpose of these section 18 
actions only, the Agency has assumed the residue of concern is 
tebufenozide per se.

B. Analytical Enforcement Methodology

    Adequate enforcement methodology (example - gas chromatography) is 
available to enforce the tolerance expression. The method may be 
requested from: Calvin Furlow, PRRIB, IRSD (7502C), Office of Pesticide 
Programs, Environmental Protection Agency, 401 M St., SW., Washington, 
DC 20460. Office location and telephone number: Rm 101FF, CM #2, 1921 
Jefferson Davis Hwy., Arlington, VA, (703) 305-5229.

C. Magnitude of Residues

    Residues of tebufenozide per se are not expected to exceed 1.0 ppm 
on lychee and longan as a result of these section 18 uses.

D. International Residue Limits

    There are currently no Canadian, or Mexican listings for 
tebufenozide residues. Codex maximum residue levels (MRLs) have been 
set for tebufenozide at 0.1 ppm for rice (husked), 0.05 ppm for 
walnuts, and 1 ppm for pome fruits.

E. Rotational Crop Restrictions

    Rotational crop restrictions do not apply to lychee and longan 
since they are tree crops.

V. Conclusion

    Therefore, the tolerance is established for residues of 
tebufenozide in lychee and longan at 1.0 ppm.

VI. 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.

[[Page 13093]]

    Any person may, by May 17, 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 
rulemaking. The objections submitted must specify the provisions of the 
regulation deemed objectionable and the grounds for the objections (40 
CFR 178.25). Each objection must be accompanied by the fee prescribed 
by 40 CFR 180.33(i). EPA is authorized to waive any fee requirement 
``when in the judgement of the Administrator such a waiver or refund is 
equitable and not contrary to the purpose of this subsection.'' For 
additional information regarding tolerance objection fee waivers, 
contact James Tompkins, Registration Division (7505C), Office of 
Pesticide Programs, Environmental Protection Agency, 401 M St., SW., 
Washington, DC 20460. Office location, telephone number, and e-mail 
address: Rm. 239, CM #2, 1921 Jefferson Davis Hwy., Arlington, VA, 
(703) 305-5697, tompkins.jim@epa.gov. Requests for waiver of tolerance 
objection fees should be sent to James Hollins, Information Resources 
and Services Division (7502C), Office of Pesticide Programs, 
Environmental Protection Agency, 401 M St., SW., Washington, DC 20460.
    If a hearing is requested, the objections must include a statement 
of the factual issues on which a hearing is requested, the requestor's 
contentions on such issues, and a summary of any evidence relied upon 
by the requestor (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.

VII. Public Record and Electronic Submissions

    EPA has established a record for this regulation under docket 
control number [OPP-300799] (including any comments and data submitted 
electronically). A public version of this record, including printed, 
paper versions of electronic comments, which does not include any 
information claimed as CBI, is available for inspection from 8:30 a.m. 
to 4 p.m., Monday through Friday, excluding legal holidays. The public 
record is located in Rm. 119 of the Public Information and Records 
Integrity Branch, Information Resources and Services Division (7502C), 
Office of Pesticide Programs, Environmental Protection Agency, CM #2, 
1921 Jefferson Davis Hwy., Arlington, VA.
    Objections and hearing requests may be sent by e-mail directly to 
EPA at:
    opp-docket@epa.gov.

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

VIII. Regulatory Assessment Requirements

A. Certain Acts and Executive Orders

    This final rule establishes a tolerance under section 408 of the 
FFDCA. 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 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(l)(6), such as the 
tolerance in this final rule, do not require the issuance of a proposed 
rule, the requirements of the Regulatory Flexibility Act (RFA) (5 
U.S.C. 601 et seq.) do not apply. Nevertheless, the Agency previously 
assessed whether establishing tolerances, exemptions from tolerances, 
raising tolerance levels or expanding exemptions might adversely impact 
small entities and concluded, as a generic matter, that there is no 
adverse economic impact. The factual basis for the Agency's generic 
certification for tolerance actions published on May 4, 1981 (46 FR 
24950), and was provided to the Chief Counsel for Advocacy of the Small 
Business Administration.

B. Executive Order 12875

    Under Executive Order 12875, entitled Enhancing the 
Intergovernmental Partnership (58 FR 58093, October 28, 1993), EPA may 
not issue a regulation that is not required by statute and that creates 
a mandate upon a State, local or tribal government, unless the Federal 
government provides the funds necessary to pay the direct compliance 
costs incurred by those governments. If the mandate is unfunded, EPA 
must provide to OMB a description of the extent of EPA's prior 
consultation with representatives of affected State, local, and tribal 
governments, the nature of their concerns, copies of any written 
communications from the governments, and a statement supporting the 
need to issue the regulation. In addition, Executive Order 12875 
requires EPA to develop an effective process permitting elected 
officials and other representatives of State, local, and tribal 
governments ``to provide meaningful and timely input in the development 
of regulatory proposals containing significant unfunded mandates.''
    Today's rule does not create an unfunded Federal mandate on State, 
local, or tribal governments. The rule does not impose any enforceable 
duties on these entities. Accordingly, the requirements of section 1(a) 
of Executive Order 12875 do not apply to this rule.

[[Page 13094]]

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.

IX. 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 3, 1999.

Peter Caulkins,
Acting Director, Registration Division, Office of Pesticide Programs.

    Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

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

    Authority: 21 U.S.C. 321(q), 346a and 371.

    2. In Sec. 180.482, add the following commodities to the table in 
paragraph (b) to read as follows:


Sec. 180.482  Tebufenozide; tolerances for residues.

*    *    *    *    *
    (b)    *    *    *


------------------------------------------------------------------------
                                                          Expiration/
            Commodity              Parts per million    revocation date
------------------------------------------------------------------------

               *      *      *      *      *      *      *
Longan..........................  1.0                 12/31/01
Lychee..........................  1.0                 12/31/01

               *      *      *      *      *      *      *
------------------------------------------------------------------------

*    *    *    *    *

[FR Doc. 99-6385 Filed 3-16-99; 8:45 am]
BILLING CODE 6560-50-F
Tebufenozide; Pesticide Tolerances for Emergency Exemptions

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