PMEP Home Page --> Pesticide Active Ingredient Information --> Insecticides and Miticides --> Insecticides, R to Z --> Tebufenozide --> Tebufenozide - Pesticide Tolerances 12/98

Tebufenozide - Pesticide Tolerances for Emergency Exemptions 12/98

[Federal Register: December 18, 1998 (Volume 63, Number 243)]
[Rules and Regulations]
[Page 70030-70035]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr18de98-18]

-----------------------------------------------------------------------

ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-300766; FRL-6049-4]
RIN 2070-AB78
Tebufenozide; Pesticide Tolerances for Emergency Exemptions
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.

-----------------------------------------------------------------------

SUMMARY: This regulation establishes a time-limited tolerance for
residues of the insecticide tebufenozide, benzoic acid, 3,5-dimethyl-1-
(1,1-dimethylethyl)-2-(4-ethylbenzoyl) hydrazide in or on eggs; grass,
forage; grass, hay; hogs, fat; hogs, kidney; hogs, liver; hogs, meat;
hogs, mbyp; peanuts; peanut, hay; peanuts, meal; peanut, oil; poultry,
fat; poultry, meat; poultry, mbyp; rice, bran; rice, grain; rice,
hulls; rice, straw; and sweet potatoes. 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 on pasture land, peanuts, rice, and sweet potatoes. This
regulation establishes maximum permissible levels for residues of
tebufenozide 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. These tolerances will expire and are
revoked on December 31, 2000.

DATES: This regulation is effective December 18, 1998. Objections and
requests for hearings must be received by EPA on or before February 16,
1999.

ADDRESSES: Written objections and hearing requests, identified by the
docket control number, [OPP-300766], 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-300766], 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@epamail.epa.gov. Copies of objections and
hearing requests must be submitted as an ASCII file avoiding the use of
special characters and any form of encryption. Copies of objections and
hearing requests will also be accepted on disks in WordPerfect 5.1/6.1
file format or ASCII file format. All copies of objections and hearing
requests in electronic form must be identified by the docket control
number [OPP-300766]. 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: 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: CM #2, 1921 Jefferson Davis Hwy.,
Arlington, VA, (703) 305-6463, e-mail: Madden.barbara@epa.gov.

SUPPLEMENTARY INFORMATION: EPA, on its own initiative, pursuant to
sections 408(e) and (l)(6) of the Federal Food, Drug, and Cosmetic Act
(FFDCA), 21 U.S.C. 346a(e) and (l)(6), is establishing tolerances for
residues of the insecticide, tebufenozide in or on eggs at 0.01 part
per million (ppm); grass, forage at 5 ppm; grass, hay at 18 ppm; hogs,
fat at 0.1 ppm; hogs, kidney at 0.02 ppm; hogs, liver at 1 ppm; hogs,
meat at 0.02 ppm; hogs, mbyp at 0.1 ppm; peanuts at 0.05 ppm; peanut,
hay at 5 ppm; peanut, meal at 0.15 ppm; peanut, oil at 0.15 ppm;
poultry, fat at 0.1 ppm; poultry, meat at 0.01 ppm; poultry, mbyp 0.05
ppm; rice, bran at 0.8 ppm; rice, grain at 0.1 ppm; rice, hulls at 0.5
ppm; rice, straw at 6 ppm; and sweet potatoes at 0.25. These tolerances will
expire and are revoked on December 31, 2000. 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 below 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 Certain Commodities and
FFDCA Tolerances

    During the 1998 growing season several states (Arkansas, Louisiana,
Oklahoma, and Texas) availed themselves of the authority to declare a
crisis exemption to use tebufenozide for control of armyworms
(Spodoptera sp.) on pasture land, peanuts, rice, and sweet potatoes.
Due to the mild winter, severe drought and unusually hot summer in the
southern United States, many growers experienced heavy infestations of
armyworm. The use of tebufenozide to control armyworm is in accordance
with 40 CFR part 166, Subpart C.
    As part of its assessment of this emergency exemption, EPA assessed
the potential risks presented by residues of tebufenozide in or on
pasture land, peanuts, rice, and sweet potatoes. In doing so, EPA
considered the safety standard in FFDCA section 408(b)(2), and EPA
decided that the necessary tolerances 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 these tolerances
without notice and opportunity for public comment under section 408(e),
as provided in section 408(l)(6). Although thess tolerances will expire
and are revoked on December 31, 2000, under FFDCA section 408(l)(5),
residues of the pesticide not in excess of the amounts specified in the
tolerance remaining in or on 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 these tolerances earlier if any experience with, scientific data
on, or other relevant information on this pesticide indicate that the
residues are not safe.
    Because these tolerances are being approved under emergency
conditions EPA has not made any decisions about whether tebufenozide
meets EPA's registration requirements for use on or whether a permanent
tolerance for this use would be appropriate. Under these circumstances,
EPA does not believe that these tolerances serve as a basis for
registration of tebufenozide by a State for special local needs under
FIFRA section 24(c). Nor does these tolerances serve as the basis for
any State other than to use this pesticide on these crops 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 above.

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 time-limited tolerances for
residues of tebufenozide on eggs at 0.01 part per million (ppm); grass,
forage at 5 ppm; grass, hay at 18 ppm; hogs, fat at 0.1 ppm; hogs,
kidney at 0.02 ppm; hogs, liver at 1 ppm; hogs, meat at 0.02 ppm; hogs,
mbyp at 0.1 ppm; peanuts at 0.05 ppm; peanut, hay at 5 ppm; peanut,
meal at 0.15 ppm; peanut, oil at 0.15 ppm; poultry, fat at 0.1 ppm;
poultry, meat at 0.01 ppm; poultry, mbyp 0.05 ppm; rice, bran at 0.8
ppm; rice, grain at 0.1 ppm; rice, hulls at 0.5 ppm; rice, straw at 6
ppm; and sweet potatoes at 0.25 ppm. EPA's assessment of the dietary
exposures and risks associated with establishing these tolerances
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 below.

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 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.
    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 Reference Dose (RfD)
for tebufenozide at 0.018 milligrams/kilogram/day (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, leafy vegetables, pears,
pecans, peppers, sugar beet, sugarcane, turnip tops, milk, and
livestock commodities of cattle, goats, horses, 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 one 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 (PCT) 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 an 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%].
    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.
    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 currently
registered for use on residential non-food sites.
    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. 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 and comparing them to
conservative model estimates of concentrations of tebufenozide for
surface and ground water, 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 currently registered for use
on residential non-food sites. Therefore no short- and intermediate-
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 two-
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. 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, EPA does not
expect the aggregate exposure to exceed 100% of the RfD.
    4. Short- or intermediate-term risk. Tebufenozide is not currently
registered for use on residential non-food sites. 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 chromotography) 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 22202, (703) 305-5229.

C. Magnitude of Residues

    Residues of tebufenozide per se are not expected to exceed 0.01 ppm
On eggs; grass, forage at 5 ppm; grass, hay at 18 ppm; hogs, fat at 0.1
ppm; hogs, kidney at 0.02 ppm; hogs, liver at 1 ppm; hogs, meat at 0.02
ppm; hogs, mbyp at 0.1 ppm; peanuts at 0.05 ppm; peanut, hay at 5 ppm;
peanut, meal at 0.15 ppm; peanut, oil at 0.15 ppm; poultry, fat at 0.1
ppm; poultry, meat at 0.01 ppm; poultry, mbyp 0.05 ppm; rice, bran at
0.8 ppm; rice, grain at 0.1 ppm; rice, hulls at 0.5 ppm; rice, straw at
6 ppm; and sweet potatoes at 0.25 ppm 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 data are currently under review by the Agency.
Crops which the label allows to be treated directly can be planted at
any time. Based on preliminary data, a 30-day plantback interval is
adequate for root, tuber, bulb, leafy, brassica, fruiting, and cucurbit
vegetables. All other crops cannot be planted within 12 months of the
last tebufenozide application.

V. Conclusion

    Therefore, tolerances are established for residues of tebufenozide
in or on eggs at 0.01 ppm; grass, forage at 5 ppm; grass, hay at 18
ppm; hogs, fat at 0.1 ppm; hogs, kidney at 0.02 ppm; hogs, liver at 1
ppm; hogs, meat at 0.02 ppm; hogs, mbyp at 0.1 ppm; peanuts at 0.05
ppm; peanut, hay at 5 ppm; peanut, meal at 0.15 ppm; peanut, oil at
0.15 ppm; poultry, fat at 0.1 ppm; poultry, meat at 0.01 ppm; poultry,
mbyp 0.05 ppm; rice, bran at 0.8 ppm; rice, grain at 0.1 ppm; rice,
hulls at 0.5 ppm; rice, straw at 6 ppm; and sweet potatoes at 0.25 at
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 issued by EPA under
new section 408(e) and (l)(6) 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 February 16, 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 above (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 judgment 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. Request 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-300766] (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 Highway, Arlington, VA.
    Electronic comments may be sent directly to EPA at:
    opp-docket@epamail.epa.gov.

    Electronic comments 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 above 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 tolerances 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
tolerances in this final rule, do not require the issuance of a
proposed rule, the requirements of the Regulatory Flexibility Act (RFA)
(5 U.S.C. 601 et seq.) do not apply. Nevertheless, the Agency has
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 to 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 to 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: December 9, 1998.

Arnold E. Layne,
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. 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
------------------------------------------------------------------------

               *      *      *      *      *      *      *
Eggs............................  0.01                12/31/00

               *      *      *      *      *      *      *
Grass, forage...................  5                   12/31/00
Grass, hay......................  18                  12/31/00
Hogs, fat.......................  0.1                 12/31/00
Hogs, kidney....................  0.02                12/31/00
Hogs, liver.....................  1                   12/31/00
Hogs, meat......................  0.02                12/31/00
Hogs, mbyp......................  0.1                 12/31/00

               *      *      *      *      *      *      *
Peanuts.........................  0.05                12/31/00
Peanut, hay.....................  5                   12/31/00
Peanut, meal....................  0.15                12/31/00
Peanut, oil.....................  0.15                12/31/00

               *      *      *      *      *      *      *
Poultry, fat....................  0.1                 12/31/00
Poultry, meat...................  0.01                12/31/00
Poultry, mbyp...................  0.05                12/31/00
Rice, bran......................  0.8                 12/31/00
Rice, grain.....................  0.1                 12/31/00
Rice, hulls.....................  0.5                 12/31/00
Rice, straw.....................  6                   12/31/00

               *      *      *      *      *      *      *
Sweet potatoes..................  0.25                12/31/00
------------------------------------------------------------------------

* * * * *

[FR Doc. 98-33628 Filed 12-17-98; 8:45 am]
BILLING CODE 6560-50-F