[Federal Register Volume 64, Number 235 (Wednesday, December 8, 1999)]
[Rules and Regulations]
[Pages 68631-68637]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-31547]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-300947; FRL-6390-9]
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 a time-limited tolerance for 
residues of tebufenozide in or on soybeans. 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 soybeans. This regulation establishes a maximum 
permissible level for residues of benzoic acid, 3,5-dimethyl-1-(1,1-
dimethylethyl)-2-(4-ethylbenzoyl)hydrazide in this food commodity. The 
tolerance will expire and is revoked on December 31, 2001.

DATES: This regulation is effective December 8, 1999. Objections and 
requests for hearings, identified by docket control number OPP-300947, 
must be received by EPA on or before February 7, 2000.
ADDRESSES: Written objections and hearing requests may be submitted by 
mail, in person, or by courier. Please follow the detailed instructions 
for each method as provided in Unit VII. of the ``SUPPLEMENTARY 
INFORMATION.'' To ensure proper receipt by EPA, your objections and 
hearing requests must identify docket control number OPP-300947 in the 
subject line on the first page of your response.

FOR FURTHER INFORMATION CONTACT: By mail: Andrew Ertman, Registration 
Division (7505C), Office of Pesticide Programs, Environmental 
Protection Agency, 401 M St., SW., Washington, DC 20460; telephone 
number: (703) 308-9367; and e-mail address: [email protected].

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    You may be potentially affected by this action if you are an 
agricultural producer, food manufacturer, or pesticide manufacturer. 
Potentially

[[Page 68632]]

affected categories and entities may include, but are not limited to:

 
------------------------------------------------------------------------
                                                          Examples of
           Categories                 NAICS codes         potentially
                                                       affected entities
------------------------------------------------------------------------
Industry                          111                 Crop production
                                  112                 Animal production
                                  311                 Food manufacturing
                                  32532               Pesticide
                                                       manufacturing
------------------------------------------------------------------------

    This listing is not intended to be exhaustive, but rather provides 
a guide for readers regarding entities likely to be affected by this 
action. Other types of entities not listed in the table could also be 
affected. The North American Industrial Classification System (NAICS) 
codes have been provided to assist you and others in determining 
whether or not this action might apply to certain entities. If you have 
questions regarding the applicability of this action to a particular 
entity, consult the person listed under ``FOR FURTHER INFORMATION 
CONTACT.''

B. How Can I Get Additional Information, Including Copies of This 
Document and Other Related Documents?

    1. Electronically. You may obtain electronic copies of this 
document, and certain other related documents that might be available 
electronically, from the EPA Internet Home Page at http://www.epa.gov/. 
To access this document, on the Home Page select ``Laws and 
Regulations'' and then look up the entry for this document under the 
``Federal Register--Environmental Documents.'' You can also go directly 
to the Federal Register listings at http://www.epa.gov/fedrgstr/.
    2. In person. The Agency has established an official record for 
this action under docket control number OPP-300947. The official record 
consists of the documents specifically referenced in this action, and 
other information related to this action, including any information 
claimed as Confidential Business Information (CBI). This official 
record includes the documents that are physically located in the 
docket, as well as the documents that are referenced in those 
documents. The public version of the official record does not include 
any information claimed as CBI. The public version of the official 
record, which includes printed, paper versions of any electronic 
comments submitted during an applicable comment period is available for 
inspection in the Public Information and Records Integrity Branch 
(PIRIB), Rm. 119, Crystal Mall #2, 1921 Jefferson Davis Hwy., 
Arlington, VA, from 8:30 a.m. to 4 p.m., Monday through Friday, 
excluding legal holidays. The PIRIB telephone number is (703) 305-5805.

II. Background and Statutory Findings

    EPA, on its own initiative, in accordance with sections 408(l)(6) 
of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a, is 
establishing a tolerance for residues of the insecticide tebufenozide, 
in or on soybeans at 2.0 part per million (ppm). This tolerance will 
expire and is 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.
    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. EPA does not intend for its actions on 
section 18 related tolerances to set binding precedents for the 
application of section 408 and the new safety standard to other 
tolerances and exemptions.
    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 the Federal Insecticide, Fungicide, and Rodenticide 
Act (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 
the Food Quality Protection Act (FQPA). EPA has established regulations 
governing such emergency exemptions in 40 CFR part 166.

III. Emergency Exemption for Tebufenozide on Soybeans and FFDCA 
Tolerances

    The state of Louisiana declared a crisis for the use of 
tebufenozide on soybeans to control fall armyworms due to lack of 
efficacy of currently labeled products. EPA has authorized under FIFRA 
section 18 the use of tebufenozide on soybeans for control of fall 
armyworms in Louisiana.
    As part of its assessment of this emergency exemption, EPA assessed 
the potential risks presented by residues of tebufenozide in or on 
soybeans. 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 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 
specified in the tolerance remaining in or on soybeans 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 soybeans 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 Louisiana 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

[[Page 68633]]

information regarding the emergency exemption for tebufenozide, contact 
the Agency's Registration Division at the address provided under ``FOR 
FURTHER INFORMATION CONTACT.''

IV. 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 soybeans at 2.0 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/kilograms/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 reference dose, or 
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 interspecies 
extrapolation and 10X for intraspecies 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, and therefore, the chronic Population Adjusted Dose (cPAD), is 
0.018 mg/kg/day, which is the same as the RfD. For purposes of this 
risk assessment, the term cPAD will be used instead of RfD. The 
determination that the 10X factor be removed is based on the results of 
reproductive and developmental toxicity studies. No evidence of 
additional sensitivity to young rats or rabbits was observed following 
prenatal 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, berries, 
canola, cotton, cranberries, fruiting vegetables, leafy vegetables, 
milk, mint, pears, pecans, pome fruit, sugarcane, turnips, walnuts and 
livestock commodities of cattle, goats, hogs, horses, and sheep. 
Additionally, time-limited tolerances associated with emergency 
exemptions have been established for poultry, eggs, peanuts, rice, and 
sweet potatoes. 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 1 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 cPAD 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. The percent of the cPAD 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 cPAD below 100% for all 
subgroups U.S. population, 14% and non-nursing infants (<1 year old), 
the most highly exposed subgroup, 44%.
    Section 408(b)(2)(F) states that the Agency may use data on the 
actual PCT for assessing chronic dietary risk only if the Agency can 
make the following findings: That the data used are reliable and 
provide a valid basis to show what percentage of the food derived from 
such crop is likely to contain such pesticide residue; that the 
exposure estimate does not underestimate exposure for any significant 
subpopulation group; and if data are available on pesticide use and 
food consumption in a particular area, the exposure estimate does not 
understate exposure for the population in such area. In addition, the 
Agency must provide for periodic evaluation of any estimates used. To 
provide for the periodic evaluation of the estimate of PCT as required 
by section 408(b)(2)(F), EPA may require registrants to submit data on 
PCT.
    Estimates of PCT were used for the following crops. In all cases 
the maximum estimate was used:

[[Page 68634]]



------------------------------------------------------------------------
                     Crops                        Average      Maximum
------------------------------------------------------------------------
Almonds.......................................          <1%          <1%
Apples........................................           1%           2%
Beans/Peas, Dry...............................           0%           1%
Cabbage, Fresh................................           2%           3%
Cole Crops....................................           1%           2%
Cotton........................................           1%           4%
Pears.........................................          <5%
Spinach, Fresh................................           2%           3%
Spinach, Processed............................          20%          29%
Sugarcane.....................................           3%           5%
Walnuts.......................................          10%          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 Generic Expected Environmental 
Concentration (GENEEC) and EPA's Pesticide Root Zone Model (PRZM/EXAMS) 
for surface water, which are used to produce estimates of pesticide 
concentrations in a farm pond and Screening Concentrations in Ground 
Water (SCI-GROW), which predicts pesticide concentrations in ground 
water. 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 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 a common mechanism of 
toxicity. Section 408(b)(2)(D)(v) requires that, when considering 
whether to establish, modify, or revoke a tolerance, the Agency 
consider ``available information'' concerning the cumulative effects of 
a particular pesticide's residues and ``other substances that have a 
common mechanism of toxicity.''
    EPA does not have, at this time, available data to determine 
whether tebufenozide has a common mechanism of toxicity with other 
substances or how to include this pesticide in a cumulative risk 
assessment. Unlike other pesticides for which EPA has followed a 
cumulative risk approach based on a common mechanism of toxicity, 
tebufenozide does not appear to produce a toxic metabolite produced by 
other substances. For the purposes of this tolerance action, therefore, 
EPA has not assumed that tebufenozide has a common mechanism of 
toxicity with other substances. For 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 14% of the cPAD for the U.S. population. The major 
identifiable subgroup with the highest aggregate exposure, non-nursing 
infants (<1 year old) will utilize 44% of the cPAD. EPA generally has 
no concern for exposures below 100% of the cPAD because the cPAD 
represents the level at or below which daily aggregate dietary exposure 
over a lifetime will not pose appreciable risks to human health. 
Despite the potential for exposure to tebufenozide in drinking water, 
after calculating DWLOCs 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 cPAD.
    3. Short- and intermediate-term risk. Short- and intermediate-term 
aggregate exposure takes into account chronic dietary food and water 
(considered to be a background exposure level) plus indoor and outdoor 
residential exposure. 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.
    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.

[[Page 68635]]

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 prenatal and postnatal toxicity and 
the completeness of the data base unless EPA determines that a 
different margin of safety will be safe for infants and children. 
Margins of safety are incorporated into EPA risk assessments either 
directly through use of a margin of exposure (MOE) analysis or through 
using uncertainty (safety) factors in calculating a dose level that 
poses no appreciable risk to humans. EPA believes that reliable data 
support using the standard MOE and uncertainty factor (usually 100 for 
combined interspecies and intraspecies 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 NOELs 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. Prenatal and postnatal 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 data base for 
tebufenozide and exposure data are complete or are 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 44% of the cPAD for infants and 29% of the cPAD for 
children. EPA generally has no concern for exposures below 100% of the 
cPAD because the cPAD represents the level at or below which daily 
aggregate dietary exposure over a lifetime will not pose appreciable 
risks to human health. Despite the potential for exposure to 
tebufenozide in drinking water, after calculating DWLOCs 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 cPAD.
    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.

V. Other Considerations

A. Metabolism in Plants and Animals

    The residue of concern in plants is adequately understood and is 
tebufenozide per se. The qualitative nature of the residues in animals 
is also adequately understood based on acceptable poultry and ruminant 
metabolism studies. For animals, EPA has concluded that the residues of 
regulatory concern are tebufenozide and its metabolites benzoic acid, 
3,5-dimethyl-1-(1,1-dimethylethyl)-2-((4-
carboxymethyl)benzoyl)hydrazide), benzoic acid, 3-hydroxymethyl,5-
methyl-1-(1,1-dimethylethyl)-2-(4-ethylbenzoyl)hydrazide, the stearic 
acid conjugate of benzoic acid, 3-hydroxymethyl, 5-methyl-1-(1,1-
dimethylethyl)-2-(4-ethylbenzoyl)hydrazide and benzoic acid, 3-
hydroxymethyl-5-methyl-1-(1,1-dimethylethyl)-2-(4-(1-
hydroxyethyl)benzoyl)hydrazide.

B. Analytical Enforcement Methodology

    Adequate enforcement methodology (for example, gas chromotography) 
is available to enforce the tolerance expression. The method may be 
requested from: Calvin Furlow, PIRIB, IRSD (7502C), Office of Pesticide 
Programs, Environmental Protection Agency, 401 M St., SW., Washington, 
DC 20460; telephone number: (703) 305-5229; e-mail address: 
[email protected].

C. Magnitude of Residues

    Residues of tebufenozide per se are not expected to exceed 2.0 ppm 
on soybeans as a result of this section 18 use.

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.

VI. Conclusion

    Therefore, the tolerance is established for residues of 
tebufenozide in soybeans at 2.0 ppm.

VII. Objections and Hearing Requests

    Under section 408(g) of the FFDCA, as amended by the FQPA, any 
person may file an objection to any aspect of this regulation and may 
also request a hearing on those objections. The EPA procedural 
regulations which govern the submission of objections and requests for 
hearings appear in 40 CFR part 178. Although the procedures in those 
regulations require some modification to reflect the amendments made to 
the FFDCA by the FQPA of 1996, EPA will continue to use those 
procedures, with appropriate adjustments, until the necessary 
modifications can be made. The new section 408(g) provides essentially 
the same process for persons to ``object'' to a regulation for an 
exemption from the requirement of a tolerance issued by EPA under new 
section 408(d), as was provided in the

[[Page 68636]]

old FFDCA sections 408 and 409. However, the period for filing 
objections is now 60 days, rather than 30 days.

A. What Do I Need to Do to File an Objection or Request a Hearing?

    You must file your objection or request a hearing on this 
regulation in accordance with the instructions provided in this unit 
and in 40 CFR part 178. To ensure proper receipt by EPA, you must 
identify docket control number OPP-300947 in the subject line on the 
first page of your submission. All requests must be in writing, and 
must be mailed or delivered to the Hearing Clerk on or before February 
7, 2000.
    1. Filing the request. Your objection must specify the specific 
provisions in the regulation that you object to, and the grounds for 
the objections (40 CFR 178.25). If a hearing is requested, the 
objections must include a statement of the factual issues(s) on which a 
hearing is requested, the requestor's contentions on such issues, and a 
summary of any evidence relied upon by the objector (40 CFR 178.27). 
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.
    Mail your written request to: Office of the Hearing Clerk (1900), 
Environmental Protection Agency, 401 M St., SW., Washington, DC 20460. 
You may also deliver your request to the Office of the Hearing Clerk in 
Rm. M3708, Waterside Mall, 401 M St., SW., Washington, DC 20460. The 
Office of the Hearing Clerk is open from 8 a.m. to 4 p.m., Monday 
through Friday, excluding legal holidays. The telephone number for the 
Office of the Hearing Clerk is (202) 260-4865.
    2. Tolerance fee payment. If you file an objection or request a 
hearing, you must also pay the fee prescribed by 40 CFR 180.33(i) or 
request a waiver of that fee pursuant to 40 CFR 180.33(m). You must 
mail the fee to: EPA Headquarters Accounting Operations Branch, Office 
of Pesticide Programs, P.O. Box 360277M, Pittsburgh, PA 15251. Please 
identify the fee submission by labeling it ``Tolerance Petition Fees.''
    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 the waiver of these fees, you may contact James 
Tompkins by phone at (703) 305-5697, by e-mail at [email protected], 
or by mailing a request for information to Mr. Tompkins at Registration 
Division (7505C), Office of Pesticide Programs, Environmental 
Protection Agency, 401 M St., SW., Washington, DC 20460.
    If you would like to request a waiver of the tolerance objection 
fees, you must mail your request for such a waiver to: James Hollins, 
Information Resources and Services Division (7502C), Office of 
Pesticide Programs, Environmental Protection Agency, 401 M St., SW., 
Washington, DC 20460.
    3.  Copies for the Docket. In addition to filing an objection or 
hearing request with the Hearing Clerk as described in Unit VII.A., you 
should also send a copy of your request to the PIRIB for its inclusion 
in the official record that is described in Unit I.B.2. Mail your 
copies, identified by the docket control number OPP-300947, 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 or 
by courier, bring a copy to the location of the PIRIB described in Unit 
I.B.2. You may also send an electronic copy of your request via e-mail 
to: [email protected]. Please use an ASCII file format and avoid the 
use of special characters and any form of encryption. Copies of 
electronic objections and hearing requests will also be accepted on 
disks in WordPerfect 6.1/8.0 file format or ASCII file format. Do not 
include any CBI in your electronic copy. You may also submit an 
electronic copy of your request at many Federal Depository Libraries.

B. When Will the Agency Grant a Request for a Hearing?

    A request for a hearing will be granted if the Administrator 
determines that the material submitted shows the following: There is a 
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(s) in the manner sought 
by the requestor would be adequate to justify the action requested (40 
CFR 178.32).

VIII. Regulatory Assessment Requirements

    This final rule establishes a time-limited tolerance under FFDCA 
section 408. The Office of Management and Budget (OMB) has exempted 
these types of actions from review under Executive Order 12866, 
entitled Regulatory Planning and Review (58 FR 51735, October 4, 1993). 
This final rule does not contain any information collections subject to 
OMB approval under the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et 
seq., or impose any enforceable duty or contain any unfunded mandate as 
described under Title II of the Unfunded Mandates Reform Act of 1995 
(UMRA) (Public Law 104-4). Nor does it require any prior consultation 
as specified by Executive Order 13084, entitled Consultation and 
Coordination with Indian Tribal Governments (63 FR 27655, May 19, 
1998); 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 or any Agency action under Executive Order 13045, 
entitled Protection of Children from Environmental Health Risks and 
Safety Risks (62 FR 19885, April 23, 1997). This action does not 
involve any technical standards that would require Agency consideration 
of voluntary consensus standards pursuant to section 12(d) of the 
National Technology Transfer and Advancement Act of 1995 (NTTAA), 
Public Law 104-113, section 12(d) (15 U.S.C. 272 note). Since 
tolerances and exemptions that are established on the basis of a FIFRA 
section 18 petition under FFDCA section 408, 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. In addition, the Agency has determined that this 
action will not have a substantial direct effect on States, on the 
relationship between the national government and the States, or on the 
distribution of power and responsibilities among the various levels of 
government, as specified in Executive Order 13132, entitled Federalism 
(64 FR 43255, August 10, 1999). Executive Order 13132 requires EPA to 
develop an accountable process to ensure ``meaningful and timely input 
by State and local officials in the development of regulatory policies 
that have federalism implications.'' ``Policies that have federalism 
implications'' is defined in the Executive Order to

[[Page 68637]]

include regulations that have ``substantial direct effects on the 
States, on the relationship between the national government and the 
States, or on the distribution of power and responsibilities among the 
various levels of government.'' This final rule directly regulates 
growers, food processors, food handlers and food retailers, not States. 
This action does not alter the relationships or distribution of power 
and responsibilities established by Congress in the preemption 
provisions of FFDCA section 408(n)(4).

IX. Submission to Congress and the General Accounting Office

    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 this final rule in the Federal Register. This final 
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: November 17, 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, by adding alphabetically to the table in 
paragraph (b), the following commodity to read as follows:


Sec. 180.482   Tebufenozide; tolerances for residues.

    *    *    *    *    *
    (b) *    *    *

 
------------------------------------------------------------------------
                                                     Parts   Expiration/
                    Commodity                         per     revocation
                                                    million      date
------------------------------------------------------------------------
 
                   *        *        *      *        *
Soybeans.........................................   2.0         12/31/01
 
                   *        *        *      *        *
------------------------------------------------------------------------

*      *      *      *      *      

[FR Doc. 99-31547 Filed 12-7-99; 8:45 am]
BILLING CODE 6560-50-F