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Tebufenozide - Pesticide Tolerances for Emergency Exemptions for Lychee 3/99

[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