[Federal Register Volume 64, Number 188 (Wednesday, September 29, 1999)]
[Rules and Regulations]
[Pages 52457-52463]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-25314]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-300923; FRL-6383-6]
RIN 2070-AB78


Tebufenozide; Pesticide Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of 
Tebufenozide benzoic acid, 3,5-dimethyl-,1-(1,1-dimethylethyl)-2-(4-
ethylbenzoyl) hydrazide in or on turnips and canola. The Interregional 
Research Project Number 4 (IR-4) requested this tolerance under the 
Federal Food, Drug, and Cosmetic Act, as amended by the Food Quality 
Protection Act of 1996.

DATES: This regulation is effective September 29, 1999. Objections and 
requests for hearings, identified by docket control number OPP-300923, 
must be received by EPA on or before November 29, 1999.

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 VI. of the ``SUPPLEMENTARY 
INFORMATION'' section. To ensure proper receipt by EPA, your objections 
and hearing requests must identify docket control number OPP-300923 in 
the subject line on the first page of your response.

FOR FURTHER INFORMATION CONTACT: By mail: Shaja R. Brothers, 
Registration Division (7505C), Office of Pesticide Programs, 
Environmental Protection Agency, 401 M St., SW., Washington, DC 20460; 
telephone number: (703) 308-3194; and e-mail address: brothers.shaja 
@epamail.epa.gov.

 SUPPLEMENTARY INFORMATION:

 I. General Information

A. Does this Action Apply to Me?

    You may be affected by this action if you are an agricultural 
producer, food manufacturer, or pesticide manufacturer. Potentially 
affected categories and entities may include, but are not limited to:

------------------------------------------------------------------------
                                                 Examples of Potentially
              Categories                NAICS       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 in the ``FOR FURTHER INFORMATION 
CONTACT'' section.

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-300923. 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

[[Page 52458]]

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

    In the Federal Register of February 9, 1999 (64 FR 6351) (FRL- 
6058-3), EPA issued a notice pursuant to section 408 of the Federal 
Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a as amended by the 
Food Quality Protection Act of 1996 (FQPA) (Public Law 104-170) 
announcing the filing of pesticide petitions (PP) for tolerance by IR-
4. This notice included a summary of the petitions prepared by the Rohm 
and Haas Company, the registrant. There were no comments received in 
response to the notice of filing.
    The petitions requested that 40 CFR 180.482 be amended by 
establishing tolerances for residues of the insecticide tebufenozide, 
in or on turnip tops, turnip roots, canola seed, and refined canola oil 
at 9.0, 0.25, 1.75, and 3.75 part per million (ppm), respectively. The 
petitions were subsequently amended by IR-4 to propose tolerances for 
turnip tops at 9.0 ppm, turnip roots at 0.3 ppm, canola seed at 2.0 
ppm, and canola oil, refined at 4.0 ppm.
    Section 408(b)(2)(A)(i) of the FFDCA allows EPA to establish a 
tolerance (the legal limit for a pesticide chemical residue in or on a 
food) only if EPA determines that the tolerance is ``safe.'' Section 
408(b)(2)(A)(ii) defines ``safe'' to mean that ``there is a reasonable 
certainty that no harm will result from aggregate exposure to the 
pesticide chemical residue, including all anticipated dietary exposures 
and all other exposures for which there is reliable information.'' This 
includes exposure through drinking water and in residential settings, 
but does not include occupational exposure. Section 408(b)(2)(C) 
requires EPA to give special consideration to exposure of infants and 
children to the pesticide chemical residue in establishing a tolerance 
and to ``ensure that there is a reasonable certainty that no harm will 
result to infants and children from aggregate exposure to the pesticide 
chemical residue....''
    EPA performs a number of analyses to determine the risks from 
aggregate exposure to pesticide residues. For further discussion of the 
regulatory requirements of section 408 and a complete description of 
the risk assessment process, see the final rule on Bifenthrin Pesticide 
Tolerances (62 FR 62961, November 26, 1997) (FRL-5754-7).

III. Aggregate Risk Assessment and Determination of Safety

    Consistent with section 408(b)(2)(D), EPA has reviewed the 
available scientific data and other relevant information in support of 
this action. EPA has sufficient data to assess the hazards of 
tebufenozide and to make a determination on aggregate exposure, 
consistent with section 408(b)(2), for tolerances for residues of 
tebufenozide on turnip tops, turnip roots, canola seed, and refined 
canola oil at 9.0, 0.3, 2.0, and 4.0 ppm, respectively. 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 in unit II.A. of the Final rule on Tebufenozide Pesticide 
Tolerances published in the Federal Register on April 7, 1999 (64 FR 
16850) (FRL-6072-6).

B. Toxicological Endpoints

    The toxicology endpoints for tebufenozide are discussed in Unit 
II.B. of the Final rule on Tebufenozide Pesticide Tolerances published 
in the Federal Register of April 7, 1999.

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. Canola meal and turnip tops are ruminant 
feed item. Permanent tolerances for livestock commodities (excluding 
poultry) were published in the Federal Register (64 FR 39060, July 21, 
1999). Risk assessments were conducted by EPA to assess dietary 
exposures from tebufenozide as follows:
    Section 408(b)(2)(F) states that the Agency may use data on the 
actual percent of crop treated (PCT) for assessing chronic dietary risk 
only if the Agency can make the following findings: That the data used 
are reliable and provide a valid basis to show what percentage of the 
food derived from such crop is likely to contain such pesticide 
residue; that the exposure estimate does not underestimate exposure for 
any significant subpopulation group; and if data are available on 
pesticide use and food consumption in a particular area, the exposure 
estimate does not understate exposure for the population in such area. 
In addition, the Agency must provide for periodic evaluation of any 
estimates used. To provide for the periodic evaluation of the estimate 
of PCT as required by section 408(b)(2)(F), EPA may require registrants 
to submit data on PCT.
    The Agency used PCT information as follows:
    Estimates of PCT were used for the following crops. In all cases 
the maximum estimate was used. Almonds: average < 1% maximum < 1%, 
apples: average 1% maximum 2%, beans/peas, dry: average 0% maximum 1%, 
cotton: average 1% maximum 4%, sugarcane: average 3% maximum 5%, and 
walnuts: average 10% maximum 16%.
    The Agency believes that the three conditions, discussed in section 
408 (b)(2)(F) in this unit concerning the Agency's responsibilities in 
assessing chronic dietary risk findings, have been met. The PCT 
estimates are derived from Federal and private market survey data, 
which are reliable and have a valid basis. Typically, a range of 
estimates are supplied and the upper end of this range is assumed for 
the exposure assessment. By using this upper end estimate of the PCT, 
the Agency is reasonably certain that 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

[[Page 52459]]

have available information on the regional consumption of food to which 
may be applied in a particular area.
    i. Acute exposure and risk. Acute dietary risk assessments are 
performed for a food-use pesticide if a toxicological study has 
indicated the possibility of an effect of concern occurring as a result 
of a 1-day or single exposure. Toxicity observed in oral toxicity 
studies were not attributable to a single dose (exposure). No 
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. This risk assessment is not 
required. The Agency considers acute exposure/risk to be negligible.
    ii. Chronic exposure and risk. The residue of concern for 
tebufenozide in plant and animal commodities is the parent compound per 
se. The chronic population adjusted dose (cPAD) used for the chronic 
dietary analysis is 0.018 mg/kg/day. In performing chronic dietary 
exposure and risk analysis, the Agency used the Dietary Exposure 
Evaluation Model (DEEM), which incorporates data from the Continuing 
Survey of Food Intake by Individuals (CSFII) for the period, 1989 to 
1992. Some refinement to the dietary exposure estimates was made 
through the use of percent-of-crop-treated data. The resulting 
Anticipated Residue Contributions (ARC) for the U.S. population and 
various DEEM population subgroups can be determined. Of these 
subgroups, the highest exposure is projected for children ages 1-6 
years, whose chronic intake is estimated as 73% of the cPAD. Percent 
cPAD values for other subgroups include: U.S. Population for the 48 
states (36%), all infants less than 1 yr. (52%), and children 7 to 12 
yrs. (46%). Generally, in the absence of additional safety factors, the 
Agency is not concerned with exposures less than 100% of the cPAD. 
Thus, for all populations, the chronic human health risk from exposure 
to tebufenozide in foods is below the Agency's level of concern.
    2. From drinking water. Available data suggest that tebufenozide 
ranges from moderately persistent to persistent and is mobile; thus, 
tebufenozide could potentially leach to ground water and runoff to 
surface water under certain environmental conditions. There is no 
Maximum Contaminant Level (MCL) for residues of tebufenozide in 
drinking water. No drinking water Health Advisories have been issued 
for tebufenozide. There is no entry for tebufenozide in the 
``Pesticides in Groundwater Database (EPA 734-12-92-001, September 
1992).
    i. Acute exposure and risk. Because no acute dietary endpoint was 
determined, the Agency concludes that there is a reasonable certainty 
of no harm from acute exposure from drinking water.
    ii. Chronic exposure and risk. Submitted environmental fate studies 
suggest that tebufenozide ranges from moderately persistent to 
persistent and is mobile; thus, tebufenozide could potentially leach to 
ground water and runoff to surface water under certain environmental 
conditions. There is no established MCL for residues of tebufenozide in 
drinking water. No drinking water Health Advisories have been issued 
for tebufenozide. There is no entry for tebufenozide in the 
``Pesticides in Groundwater Database.'' Monitoring data are not 
available to assess the human exposure to tebufenozide via drinking 
water. In lieu of these, EPA has calculated the Tier I estimated 
environmental concentrations in drinking water (EECs) for tebufenozide 
using generic expected environmental concentration (GENEEC) (surface 
water) and screening concentration in ground water (SCI-GROW) (ground 
water) for use in the human health risk assessment. The maximum 
application rate for tebufenozide is 0.25 pound (lb) active ingredient 
(a.i.) with 5 applications per year on pecans. This application 
scenario was used to calculate the EECs for the human health risk 
assessment. Due to the wide range of aerobic soil half-life values, 
GENEEC and SCIGROW were run based on aerobic half-lives of 66 
(California Loam) and 729 (worst-case soil with low microbial activity) 
days. For surface water, the chronic (56-day) values are 13.3 parts per 
billion (ppb) and 16.5 ppb for the half-lives of 66 and 729 days, 
respectively. The ground water screening concentrations are 0.16 ppb 
and 1.04 ppb for the half-lives of 66 and 729 days, respectively. These 
values represent upper-bound estimates of the concentrations that might 
be found in surface and ground water due to the use of tebufenozide on 
pecans. In performing this risk assessment, EPA has calculated drinking 
water levels of comparison (DWLOCs) for each of the DEEM population 
subgroups. Within each subgroup, the population with the highest 
estimated exposure was used to determine the maximum concentration of 
tebufenozide that can occur in drinking water without causing an 
unacceptable human health risk. As a comparison value, EPA has used the 
16.5 ppb value in this risk assessment, as this represents a worst-case 
scenario. The DWLOCs for tebufenozide are above the drinking water 
estimated concentrations (DWEC) of 16.5 ppb for all population 
subgroups. Therefore, the human health risk from exposure to 
tebufenozide through drinking water in not likely to exceed EPA's level 
of concern.
    Because the Agency lacks sufficient water-related exposure data to 
complete a comprehensive drinking water risk assessment for many 
pesticides, EPA has commenced and nearly completed a process to 
identify a reasonable yet conservative bounding figure for the 
potential contribution of water-related exposure to the aggregate risk 
posed by a pesticide. In developing the bounding figure, EPA estimated 
residue levels in water for a number of specific pesticides using 
various data sources. The Agency then applied the estimated residue 
levels, in conjunction with appropriate toxicological endpoints cPADs 
or acute dietary no observed adverse effect levels (NOAELs) and 
assumptions about body weight and consumption, to calculate, for each 
pesticide, the increment of aggregate risk contributed by consumption 
of contaminated water. While EPA has not yet pinpointed the appropriate 
bounding figure for exposure from contaminated water, the ranges the 
Agency is continuing to examine are all below the level that would 
cause to exceed the cPAD if the tolerances being considered in this 
document were granted. The Agency has therefore concluded that the 
potential exposures associated with water, even at the higher levels 
the Agency is considering as a conservative upper bound, would not 
prevent the Agency from determining that there is a reasonable 
certainty of no harm if the tolerances are granted.
    3. From non-dietary exposure. Tebufenozide is not currently 
registered for use on residential non-food sites. The Agency concludes 
that there are no acute, chronic, short- or intermediate-term non-
dietary exposure scenarios.
    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

[[Page 52460]]

of toxicity with other substances or how to include this pesticide in a 
cumulative risk assessment. Unlike other pesticides for which EPA has 
followed a cumulative risk approach based on a common mechanism of 
toxicity, tebufenozide does not appear to produce a toxic metabolite 
produced by other substances. For the purposes of this tolerance 
action, therefore, EPA has not assumed that tebufenozide has a common 
mechanism of toxicity with other substances. For information regarding 
EPA's efforts to determine which chemicals have a common mechanism of 
toxicity and to evaluate the cumulative effects of such chemicals, see 
the final rule for Bifenthrin Pesticide Tolerances (62 FR 62961, 
November 26, 1997).

 D. Aggregate Risks and Determination of Safety for U.S. Population

    1. Acute risk. Since no acute toxicity endpoints were identified 
for tebufenozide, the Agency concludes that acute aggregate risk from 
the use of the pesticide will not pose an unacceptable risk to human 
health.
    2. Chronic risk. Using the ARC exposure assumptions described in 
this unit, EPA has concluded that aggregate exposure from food will 
utilize 10% of the cPAD for the U.S. population. The major identifiable 
subgroup with the highest aggregate exposure is children (1-6 years 
old) at 21% of the cPAD discussed below. Submitted environmental fate 
studies suggest that tebufenozide is moderately persistent to 
persistent and mobile; thus, tebufenozide could potentially leach to 
ground water and runoff to surface water under certain environmental 
conditions. The modeling data for tebufenozide indicate levels less 
than EPA's DWLOC. 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. Since there is no potential for 
exposure to tebufenozide from residential uses, EPA does not expect the 
aggregate exposure to exceed 100% of the cPAD. EPA concludes that there 
is a reasonable certainty that no harm will result from aggregate 
exposure to tebufenozide residues.
    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. Due to lack of endpoints and/or residential use 
registrations, the agency concludes that short- and intermediate-term 
risk via non-dietary routes (e.g., dermal, inhalation, non-dietary 
oral) will not pose an unacceptable risk to human health.
    4. Aggregate cancer risk for U.S. population. Tebufenozide has been 
classified as a Group E chemical (no evidence of carcinogenicity for 
humans). The Agency concludes that the aggregate cancer risk for the 
U.S. population is not impacted by the establishment of these 
tolerances.
    5. Determination of safety. Based on the risk assessments discussed 
above, EPA concludes that there is a reasonable certainty that no harm 
will result from aggregate exposure to tebufenozide residues.

E. Aggregate Risks and Determination of Safety for Infants and Children

    1. Safety factor for infants and children-- i. In general. In 
assessing the potential for additional sensitivity of infants and 
children to residues of tebufenozide, EPA considered data from 
developmental toxicity studies in the rat and rabbit and a 2-generation 
reproduction study in the rat. The developmental toxicity studies are 
designed to evaluate adverse effects on the developing organism 
resulting from maternal pesticide exposure gestation. Reproduction 
studies provide information relating to effects from exposure to the 
pesticide on the reproductive capability of mating animals and data on 
systemic toxicity.
    FFDCA section 408 provides that EPA shall apply an additional 
tenfold margin of safety for infants and children in the case of 
threshold effects to account for pre-and post-natal toxicity and the 
completeness of the database unless EPA determines that a different 
margin of safety will be safe for infants and children. Margins of 
safety are incorporated into EPA risk assessments either directly 
through use of a margin of exposure (MOE) analysis or through using 
uncertainty (safety) factors in calculating a dose level that poses no 
appreciable risk to humans. EPA believes that reliable data support 
using the standard uncertainty factor (usually 100 for combined inter- 
and intra-species variability) and not the additional tenfold MOE/
uncertainty factor when EPA has a complete data base under existing 
guidelines and when the severity of the effect in infants or children 
or the potency or unusual toxic properties of a compound do not raise 
concerns regarding the adequacy of the standard MOE/safety factor.
    ii. Developmental toxicity studies. Developmental toxicity studies 
showed no increased sensitivity in fetuses as compared to maternal 
animals following in utero exposures in rats and rabbits. See 
discussion under Unit II.A of the Final rule for tebufenozide 
tolerances published in the Federal Register on April 7, 1999.
    iii. Reproductive toxicity study. Multi-generation reproduction 
toxicity studies in rats showed no increased sensitivity in pups as 
compared to adults and offsprings. See discussion under Unit II.A of 
the Final Rule for tebufenozide tolerances published in the Federal 
Register on April 7, 1999.
    iv. Pre- and post-natal sensitivity. The Agency determined that 
available data provide no indication of increased sensitivity of rats 
or rabbits to in utero and/or postnatal exposure to tebufenozide.
    v. Conclusion. The Agency believes that reliable data support using 
the standard 100-fold safety factor for assessing sensitivity to 
residues of tebufenozide and that an additional 10-fold margin of 
safety for infants and children is not warranted. There is a complete 
toxicity database for tebufenozide and exposure data are complete or 
estimated based on data that reasonably account for potential 
exposures.
    2. Acute risk. No acute toxicity endpoints for tebufenozide have 
been identified and this risk assessment is not required. No acute 
aggregate risk exist.
    3. Chronic risk. Using the exposure assumptions described in this 
unit, EPA has concluded that aggregate exposure to tebufenozide from 
food will utilize 21% of the cPAD for children (1-6) the most highly 
exposed population subgroup. 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. EPA does not expect the 
aggregate exposure from tebufenozide in food, drinking water, and from 
non-dietary exposure to exceed the Agency's level of concern.
    4. Short- or intermediate-term risk. Since no short- or 
intermediate-term toxicological endpoints were identified by the Agency 
for tebufenozide and there are no registered uses that would result in 
residential exposure, the Agency concludes that this risk criterion is 
negligible and the subject tolerances adequately protect the safety of 
infants and children.
    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.

[[Page 52461]]

IV. Other Considerations

A. Metabolism in Plants and Animals

    The qualitative nature of the residue in plants is adequately 
understood based upon acceptable apple, sugar beet, and rice metabolism 
studies. EPA has concluded that the residue of regulatory concern 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

     Turnips. IR-4 used Rohm and Haas High Performance Liquid 
Chromatographic (HPLC)/Ultra Violet (UV) analytical method TR-34-94-41 
to collect residue data from the field trials on turnips. IR-4 slightly 
modified the HPLC system used to quantify tebufenozide residues, but 
made no substantive changes. Adequate recovery data and representative 
chromatograms for turnip roots and tops were provided. The limit of 
quantitation (LOQ) in turnip roots and tops is 0.01 ppm. This method 
has been conditionally approved by the Agency as an analytical 
enforcement method, pending incorporation of the corrections noted 
during the Analytical Chemistry Branch/BEAD's petition method 
validation (PMV) trial. This method is considered adequate for the 
enforcement of tebufenozide residues in/on turnip roots and tops. A 
copy of the corrected version of TR-34-94-41 will be submitted for 
publication in the Pesticide Analytical Manual, Volume II (PAM II).
    Canola. IR-4 used Rohm and Haas HPLC/UV analytical method TR-34-96-
135 to collect residue data from the field trials on canola. Adequate 
validation data and representative chromatograms for canola commodities 
(seed, meal, oil, soapstock) were provided. The LOQ is 0.01 ppm for the 
seed and meal and 0.03 ppm for the oil and soapstock. A PMV is not 
required, as this method is similar to those for walnuts and apples 
which have been successfully validated. A copy of TR-34-96-135 
incorporating the corrections specified in the Independent Laboratory 
Validation (ILV) study will be submitted for publication in PAM II.
    Adequate enforcement methodology (example - gas chromotography) is 
available to enforce the tolerance expression for canola seed and 
refined oil and turnip roots and tops. These methods may be requested 
from: Calvin Furlow, PRRIB, 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

     Turnips. The submitted turnip top and root residue data are 
adequate to support the proposed use. The six studies on turnips 
adequately address the number and geographic representation of studies 
suggested in the OPPTS Test Guidelines. Residues of tebufenozide ranged 
from 0.02 to 0.23 ppm for turnip roots and from 0.31 to 8.31 ppm for 
turnip tops. The proposed tolerances of 9.0 ppm and 0.3 ppm are 
appropriate on turnip tops and turnip roots respectively.
    Canola. The submitted canola residue data are adequate to support 
the proposed use. Residues of tebufenozide ranged from 0.29 to 1.64 ppm 
for canola seed. The proposed tolerance 2.0 ppm on canola seed is 
appropriate. Processed commodities from canola (meal, oil, and 
soapstock) were generated using procedures that mimic commercial 
practice. Residues of tebufenozide did not concentrate in canola meal 
(average concentration factor = 0.16X) or soapstock (1.1X), but did 
concentrate in refined oil (an average of 2.3X). Based on the highest 
average field trial value for canola seed (1.58 ppm), a tolerance of 
4.0 ppm is appropriate for refined canola oil.

D. International Residue Limits

     No CODEX, Canadian or Mexican limits for tebufenozide were 
established on the subject crops at the time of this review.

V. Conclusion

    Therefore, the tolerance is established for residues of 
tebufenozide; benzoic acid, 3,5-dimethyl-, 1-(1,1-dimethylethyl)-2-(4-
ethylbenzoyl) hydrazide in turnip tops, turnip roots, canola seed, and 
refined canola oil at 9.0, 0.3, 2.0, and 4.0 ppm, respectively.

VI. 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 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-300923 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 November 
29, 1999.
    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 
Room M3708,

[[Page 52462]]

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 be 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 VI.A. of 
this preamble, you should also send a copy of your request to the PIRB 
for its inclusion in the official record that is described in Unit 
I.B.2. of this preamble. Mail your copies, identified by docket number 
OPP-300923, 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 PRIB described in Unit I.B.2. of this preamble. You may 
also send an electronic copy of your request via e-mail to: opp-
[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 5.1/6.1 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).

VII. Regulatory Assessment Requirements

    This final rule establishes tolerances under section 408(d) of the 
FFDCA in response to a petition submitted to the Agency. The Office of 
Management and Budget (OMB) has exempted these types of actions from 
review under Executive Order 12866, entitled Regulatory Planning and 
Review (58 FR 51735, October 4, 1993). This final rule does not contain 
any information collections subject to OMB approval under the Paperwork 
Reduction Act (PRA), 44 U.S.C. 3501 et seq., or impose any enforceable 
duty or contain any unfunded mandate as described under Title II of the 
Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law 104-4). Nor 
does it require prior consultation with State, local, and tribal 
government officials as specified by Executive Order 12875, entitled 
Enhancing the Intergovernmental Partnership (58 FR 58093, October 28, 
1993) and Executive Order 13084, entitled Consultation and Coordination 
with Indian Tribal Governments (63 FR 27655, May 19,1998), or special 
consideration of environmental justice related issues under 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). 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 12612, 
entitled Federalism (52 FR 41685, October 30, 1987). This action 
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 the Federal Food, Drug, and Cosmetic Act, 
21 U.S.C. 346a(b)(4). 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). In addition, since 
tolerances and exemptions that are established on the basis of a 
petition under FFDCA section 408(d), 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.

VIII. Submission to Congress and the Comptroller General

     The Congressional Review Act, 5 U.S.C. 801 et seq., as added by 
the Small Business Regulatory Enforcement Fairness Act of 1996, 
generally provides that before a rule may take effect, the agency 
promulgating the rule must submit a rule report, which includes a copy 
of the rule, to each House of the Congress and 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 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: September 20, 1999.

James Jones,

Director, Registration Division, Office of Pesticide Programs.
    Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

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

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


[[Page 52463]]


    2. In Sec. 180.482, the table to paragraph (a)(1) is amended by 
adding entries for canola, seed; canola, refined oil; turnip, tops; and 
turnip, roots, to read as follows:


Sec. 180.482   Tebufenozide; tolerances for residues..

    (a) *  *  *

 
------------------------------------------------------------------------
                                                                  Parts
                           Commodity                               per
                                                                 million
------------------------------------------------------------------------
 
                  *        *        *        *        *
Canola, refined oil............................................    4.0
Canola, seed...................................................    2.0
                  *        *        *        *        *
Turnip, roots..................................................    0.3
Turnip, tops...................................................    9.0
------------------------------------------------------------------------

*      *      *      *      *
[FR Doc. 99-25314 Filed 9-28-99; 8:45 am
BILLING CODE 6560-50-F