Tebufenozide; Pesticide Tolerances for Emergency Exemptions

Note: EPA no longer updates this information, but it may be useful as a reference or resource.
 [Federal Register: May 15, 1998 (Volume 63, Number 94)]
[Rules and Regulations]               
[Page 26986-26992]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr15my98-23]

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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-300640; FRL-5784-8]
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 peppers (bell and non-bell) . 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 peppers (bell and non-bell). This 
regulation establishes a maximum permissible level for residues of 
tebufenozide in this food commodity pursuant to section 408(l)(6) of 
the Federal Food, Drug, and Cosmetic Act, as amended by the Food 
Quality Protection Act of 1996. The tolerance will expire and is 
revoked on September 30, 1999.

DATES: This regulation is effective May 15, 1998. Objections and 
requests for hearings must be received by EPA on or before July 14, 
1998.
ADDRESSES: Written objections and hearing requests, identified by the 
docket control number, [OPP-300640], 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-300640], 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, 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-300640]. 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: Andrew Ertman, 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: Crystal Mall #2, 1921 
Jefferson Davis Hwy., Arlington, VA, (703) 308-9367, e-mail: 
ertman.andrew@epamail.epa.gov.

SUPPLEMENTARY INFORMATION: EPA, on its own initiative, pursuant to 
section 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 a tolerance for 
residues of the insecticide tebufenozide, in or on peppers (bell and 
non-bell) at 0.5 part per million (ppm). This tolerance will expire and 
is revoked on September 30, 1999. EPA will publish a document in the 
Federal Register to remove the revoked tolerance from the Code of 
Federal Regulations.

I. Background and Statutory Authority

    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 published in the Federal Register of November 
13, 1996 (61 FR 58135) (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

[[Page 26987]]

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 tolerance 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 Peppers (Bell and Non-
bell) and FFDCA Tolerances

    The applicant indicates that emergency conditions exist because 
beet armyworm (BAW) populations have demonstrated resistance to 
registered insecticides. The survival rate of the pest has been furhter 
compounded by a mild winter and unusually dry, hot weather which has 
increased. Naturally occurring epizootics require cool, wet conditions 
to have their greatest impact on this pest. The applicant also notes 
that there are unusually large numbers of BAW and damage due to BAW in 
peppers could result in a 50% yield loss without the use of an 
effective pesticide. EPA has authorized under FIFRA section 18 the use 
of tebufenozide on peppers (bell and non-bell) for control of beet 
armyworm in Texas. After having reviewed the submission, EPA concurs 
that emergency conditions exist for this State.
    As part of its assessment of this emergency exemption, EPA assessed 
the potential risks presented by residues of tebufenozide in or on 
peppers (bell and non-bell). In doing so, EPA considered the new 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 
new safety standard and with FIFRA section 18. Consistent with the need 
to move quickly on the emergency exemption in order to address an 
urgent non-routine situation and to ensure that the resulting food is 
safe and lawful, EPA is issuing this tolerance without notice and 
opportunity for public comment under section 408(e), as provided in 
section 408(l)(6). Although this tolerance will expire and is revoked 
on September 30, 1999, under FFDCA section 408(l)(5), residues of the 
pesticide not in excess of the amounts specified in the tolerance 
remaining in or on peppers (bell and non-bell) 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 peppers (bell and non-bell) 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 Texas to use this pesticide on this crop 
under section 18 of FIFRA without following all provisions of 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. Risk Assessment and Statutory Findings

    EPA performs a number of analyses to determine the risks from 
aggregate exposure to pesticide residues. First, EPA determines the 
toxicity of pesticides based primarily on toxicological studies using 
laboratory animals. These studies address many adverse health effects, 
including (but not limited to) reproductive effects, developmental 
toxicity, toxicity to the nervous system, and carcinogenicity. Second, 
EPA examines exposure to the pesticide through the diet (e.g., food and 
drinking water) and through exposures that occur as a result of 
pesticide use in residential settings.

A. Toxicity

    1. Threshold and non-threshold effects. For many animal studies, a 
dose response relationship can be determined, which provides a dose 
that causes adverse effects (threshold effects) and doses causing no 
observed effects (the ``no-observed effect level'' or ``NOEL'').
    Once a study has been evaluated and the observed effects have been 
determined to be threshold effects, EPA generally divides the NOEL from 
the study with the lowest NOEL by an uncertainty factor (usually 100 or 
more) to determine the Reference Dose (RfD). The RfD is a level at or 
below which daily aggregate exposure over a lifetime will not pose 
appreciable risks to human health. An uncertainty factor (sometimes 
called a ``safety factor'') of 100 is commonly used since it is assumed 
that people may be up to 10 times more sensitive to pesticides than the 
test animals, and that one person or subgroup of the population (such 
as infants and children) could be up to 10 times more sensitive to a 
pesticide than another. In addition, EPA assesses the potential risks 
to infants and children based on the weight of the evidence of the 
toxicology studies and determines whether an additional uncertainty 
factor is warranted. Thus, an aggregate daily exposure to a pesticide 
residue at or below the RfD (expressed as 100% or less of the RfD) is 
generally considered acceptable by EPA. EPA generally uses the RfD to 
evaluate the chronic risks posed by pesticide exposure. For shorter 
term risks, EPA calculates a margin of exposure (MOE) by dividing the 
estimated human exposure into the NOEL from the appropriate animal 
study. Commonly, EPA finds MOEs lower than 100 to be unacceptable. This 
100-fold MOE is based on the same rationale as the 100-fold uncertainty 
factor.
    Lifetime feeding studies in two species of laboratory animals are 
conducted to screen pesticides for cancer effects. When evidence of 
increased cancer is noted in these studies, the Agency conducts a 
weight of the evidence review of all relevant toxicological data 
including short-term and mutagenicity studies and structure activity 
relationship. Once a pesticide has been classified as a potential human 
carcinogen, different types of risk assessments (e.g., linear low dose 
extrapolations or MOE calculation based on the appropriate NOEL) will 
be carried out based on the nature of the carcinogenic response and the 
Agency's knowledge of its mode of action.
    2. Differences in toxic effect due to exposure duration. The 
toxicological effects of a pesticide can vary with different exposure 
durations. EPA considers the entire toxicity data base, and based on 
the effects seen for different durations and routes of exposure, 
determines which risk assessments should be done to assure

[[Page 26988]]

that the public is adequately protected from any pesticide exposure 
scenario. Both short and long durations of exposure are always 
considered. Typically, risk assessments include ``acute'', ``short-
term'', ``intermediate term'', and ``chronic'' risks. These assessments 
are defined by the Agency as follows.
    Acute risk, by the Agency's definition, results from 1-day 
consumption of food and water, and reflects toxicity which could be 
expressed following a single oral exposure to the pesticide residues. 
High end exposure to food and water residues are typically assumed.
    Short-term risk results from exposure to the pesticide for a period 
of 1-7 days, and therefore overlaps with the acute risk assessment. 
Historically, this risk assessment was intended to address primarily 
dermal and inhalation exposure which could result, for example, from 
residential pesticide applications. However, since enaction of FQPA, 
this assessment has been expanded to include both dietary and non-
dietary sources of exposure, and will typically consider exposure from 
food, water, and residential uses when reliable data are available. In 
this assessment, risks from average food and water exposure, and high-
end residential exposure, are aggregated. High-end exposures from all 
three sources are not typically added because of the very low 
probability of this occurring in most cases, and because the other 
conservative assumptions built into the assessment assure adequate 
protection of public health. However, for cases in which high-end 
exposure can reasonably be expected from multiple sources (e.g. 
frequent and widespread homeowner use in a specific geographical area), 
multiple high-end risks will be aggregated and presented as part of the 
comprehensive risk assessment/characterization. Since the toxicological 
endpoint considered in this assessment reflects exposure over a period 
of at least 7 days, an additional degree of conservatism is built into 
the assessment; i.e., the risk assessment nominally covers 1-7 days 
exposure, and the toxicological endpoint/NOEL is selected to be 
adequate for at least 7 days of exposure. (Toxicity results at lower 
levels when the dosing duration is increased.)
    Intermediate-term risk results from exposure for 7 days to several 
months. This assessment is handled in a manner similar to the short-
term risk assessment.
    Chronic risk assessment describes risk which could result from 
several months to a lifetime of exposure. For this assessment, risks 
are aggregated considering average exposure from all sources for 
representative population subgroups including infants and children.

B. Aggregate Exposure

    In examining aggregate exposure, FFDCA section 408 requires that 
EPA take into account available and reliable information concerning 
exposure from the pesticide residue in the food in question, residues 
in other foods for which there are tolerances, residues in groundwater 
or surface water that is consumed as drinking water, and other non-
occupational exposures through pesticide use in gardens, lawns, or 
buildings (residential and other indoor uses). Dietary exposure to 
residues of a pesticide in a food commodity are estimated by 
multiplying the average daily consumption of the food forms of that 
commodity by the tolerance level or the anticipated pesticide residue 
level. The Theoretical Maximum Residue Contribution (TMRC) is an 
estimate of the level of residues consumed daily if each food item 
contained pesticide residues equal to the tolerance. In evaluating food 
exposures, EPA takes into account varying consumption patterns of major 
identifiable subgroups of consumers, including infants and children.The 
TMRC is a ``worst case'' estimate since it is based on the assumptions 
that food contains pesticide residues at the tolerance level and that 
100% of the crop is treated by pesticides that have established 
tolerances. If the TMRC exceeds the RfD or poses a lifetime cancer risk 
that is greater than approximately one in a million, EPA attempts to 
derive a more accurate exposure estimate for the pesticide by 
evaluating additional types of information (anticipated residue data 
and/or percent of crop treated data) which show, generally, that 
pesticide residues in most foods when they are eaten are well below 
established tolerances.
    Percent of crop treated estimates are derived from federal and 
private market survey data. 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 percent of crop 
treated, the Agency is reasonably certain that exposure is not 
understated for any significant subpopulation group. Further, regional 
consumption information is taken into account through EPA's computer-
based model for evaluating the exposure of significant subpopulations 
including several regional groups, to pesticide residues. For this 
pesticide, the most highly exposed population subgroup (non-nursing 
infants (<1 year old)) was not regionally based.

IV. 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 a time-limited tolerance for 
residues of tebufenozide on peppers (bell and non-bell) at 0.5 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 below.
    1. Acute toxicity. No acute dietary risk endpoint was identified by 
the Agency, therefore this risk assessment is not required.
    2. Short - and intermediate - term toxicity-- i. Short-term. NOEL = 
1,000 milligrams/kilogram/day (mg/kg/day). Concerning short-term dermal 
toxicity, the Agency noted that in a 21-day dermal toxicity study in 
rats there was no systemic toxicity observed at 1,000 mg/kg/day, the 
highest dose tested (HDT). This risk assessment is not required.
    ii. Intermediate-term. The Agency did not identify an intermediate-
term toxicology endpoint. Additionally, because there is no 
intermediate exposure scenario with this section 18 request, an 
intermediate-term risk assessment is not required.
    3. Chronic toxicity. EPA has established the RfD for tebufenozide 
at 0.018 mg/kg/day. This RfD is based on a 1-year feeding study in dogs 
with a NOEL of 1.8 mg/kg/day. An uncertainty factor of 100 was used to 
account for both the interspecies extrapolation and intraspecies 
variability. The lowest-effect-level (LEL) of 8.7 mg/kg/day was based 
on hematopoietic findings (decreased red blood cells, hematocrit, 
hemoglobin levels, and increased heinz bodies, MCV, MCH, reticulocytes, 
and platelets).

[[Page 26989]]

    4. Carcinogenicity. Tebufenozide has been classified as a Group E, 
``no evidence of carcinogenicity for humans,'' chemical by the Agency.

B. 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. A permanent tolerance has been 
established for the residues of tebufenozide in/on walnuts at 0.1 ppm. 
A permanent tolerance at 1.0 ppm has also previously been established 
for imported apples. Time limited tolerances have been established on 
apples and on associated animal commodities, cottonseed at 0.2 ppm, 
leafy vegetables (except brassica) at 5.0 ppm, brassica (cole) leafy 
vegetables at 5.0 ppm, sugar beets at 0.3 ppm, sugarcane at 0.03 ppm, 
and turnip tops at 5.0 ppm. A time limited tolerance for peppers (bell 
and non-bell) had been established at 0.5 ppm, however this tolerance 
expired on February 28, 1998. 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. Since an acute dietary endpoint has 
not been identified in the toxicology database, an assessment of acute 
dietary risk was not conducted for this section 18 request.
    ii. Chronic exposure and risk. In conducting this exposure 
assessment, EPA has made very conservative assumptions -- 100% of 
sugarcane and all other commodities having tebufenozide tolerances will 
contain tebufenozide residues and those residues would be at the level 
of the tolerance -- which result in an overestimate of human dietary 
exposure. Thus, in making a safety determination for this tolerance, 
EPA is taking into account this conservative exposure assessment. The 
existing tebufenozide tolerances (published, pending, and including the 
necessary section 18 tolerances) result in a Theoretical Maximum 
Residue Contribution (TMRC) that is equivalent to the following 
percentages of the RfD:

------------------------------------------------------------------------
Population Subgroup                     TMRC food (mg/kg/day)     %RfD
------------------------------------------------------------------------
U.S. Population - 48 States.........     0.005516                  31%
Nursing Infants (<1 year old)....     0.007384                  41%
Non-Nursing Infants (<1 year old)     0.014348                  80%
Children (1-6 years old)............     0.010646                  59%
Children (7-12 years old)...........     0.007595                  42%
Non-Hispanic Blacks.................     0.006063                  34%
Non-Hispanic Others.................     0.007358                  41%
Western Region......................     0.006033                  34%
------------------------------------------------------------------------


    The subgroups listed above are: (a) the U.S. population (48 
States); (b) those for infants and children; and, (c) the other 
subgroups for which the percentage of the RfD occupied is greater than 
that occupied by the subgroup U.S. population (48 States).
    For chronic dietary risk to tebufenozide, the population subgroup 
with the largest percentage of the RfD occupied is non-nursing infants 
(<1 year old) at 80% of the RfD.
    2. From drinking water. 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. There 
is no established 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).
     Chronic exposure and risk. 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 (RfD's or acute dietary NOEL's) 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 tebufenozide to 
exceed the RfD if the tolerance being considered in this document were 
granted. The Agency has therefore concluded that the potential 
exposures associated with tebufenozide in 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 tolerance is granted.
    3. From non-dietary exposure. Tebufenozide is not currently 
registered for any indoor or outdoor residential uses; therefore, no 
non-dietary residential exposure is anticipated.
    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.'' The Agency believes that ``available 
information'' in this context might include not only toxicity, 
chemistry, and exposure data, but also scientific policies and 
methodologies for understanding common mechanisms of toxicity and 
conducting cumulative risk assessments. For most pesticides, although 
the Agency has some information in its files that may turn out to be 
helpful in eventually determining whether a pesticide shares a common 
mechanism of toxicity with any other substances, EPA does not at this 
time have the methodologies to resolve the complex scientific issues 
concerning common mechanism of toxicity in a meaningful way. EPA has 
begun a pilot process to study this issue further through the 
examination of particular classes of pesticides. The Agency hopes that 
the results of this pilot process will increase the Agency's scientific 
understanding of this question such that EPA will be able to develop 
and apply scientific principles for better

[[Page 26990]]

determining which chemicals have a common mechanism of toxicity and 
evaluating the cumulative effects of such chemicals. The Agency 
anticipates, however, that even as its understanding of the science of 
common mechanisms increases, decisions on specific classes of chemicals 
will be heavily dependent on chemical specific data, much of which may 
not be presently available.
    Although at present the Agency does not know how to apply the 
information in its files concerning common mechanism issues to most 
risk assessments, there are pesticides as to which the common mechanism 
issues can be resolved. These pesticides include pesticides that are 
toxicologically dissimilar to existing chemical substances (in which 
case the Agency can conclude that it is unlikely that a pesticide 
shares a common mechanism of activity with other substances) and 
pesticides that produce a common toxic metabolite (in which case common 
mechanism of activity will be assumed).
    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.

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

    1. Acute risk. Since no acute endpoint was identified for 
tebufenozide, no acute risk assessment is required.
    2. Chronic risk. Using the conservative exposure assumptions 
described above, and taking into account the completeness and 
reliability of the toxicity data, EPA has concluded that dietary (food 
only) exposure to tebufenozide will utilize 31% of the RfD for the U.S. 
population. The Agency 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, EPA does not expect the aggregate 
exposure (food and water) to exceed 100% of the RfD. Since there are no 
non-dietary non-occupational exposure scenarios for tebufenozide, there 
are no additional exposure from those routes. The Agency concludes that 
there is a reasonable certainty that no harm will result from aggregate 
chronic exposure to tebufenozide residues.
    3. Short- and intermediate-term risk. Since there were no toxicity 
endpoints identified by the Agency for tebufenozide and no indoor/
outdoor residential uses, no short- or intermediate-term risk 
assessment was required.

D. Aggregate Cancer Risk for U.S. Population

    Since tebufenozide has been classified as a Group E chemical, ``no 
evidence of carcinogenicity for humans,'' no cancer risk assessment was 
required.

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 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-- a. Rats. In a developmental 
toxicity study in rats, the maternal (systemic) NOEL was 250 mg/kg/day. 
The LOEL was 1,000 mg/kg/day, based on decreased body weight and food 
consumption. The developmental (pup) NOEL was > 1,000 mg/kg/day (HDT).
    b. Rabbits. In a developmental toxicity study in rabbits, the 
maternal and developmental NOELs were >1,000 mg/kg/day (HDT).
    iii. Reproductive toxicity study-- Rats. In a multigeneration 
reproductive toxicity study in rats, the parental (systemic) NOEL was 
0.85 mg/kg/day. Splenic pigmentation changes and extramedullary 
hematopoiesis occurred at the LOEL of 12.1 mg/kg/day (Female, Male; 
F<INF>0</INF>, F<INF>1</INF>). In addition to these effects, decreased 
body weight gain and food consumption occurred at 171.1 mg/kg/day. The 
reproductive (pup) NOEL was 125 mg/kg/day. The reproductive LOEL of 
171.1 mg/kg/day, based on a slight increase in the number of pregnant 
females that either did not deliver or had difficulty and had to be 
sacrificed (F<INF>1</INF>). Additionally at the LOEL, in F<INF>1</INF> 
dams, the length of gestation increased and implantation sites 
decreased significantly. Finally, the number of pups per litter 
decreased on Lactation Day (LD) 4 to 90% of the controls for the 
F<INF>1</INF> and on LD's 0 and 4 to 80% for the second generation.
    iv. Pre- and post-natal sensitivity-- a. Pre-natal sensitivity. The 
developmental NOELs of >1,000 mg/kg/day (HDT) from the developmental 
toxicity studies in rats and rabbits demonstrate that there is no 
developmental (prenatal) toxicity present for tebufenozide. 
Additionally, these developmental NOELs are greater than 500-fold 
higher than the NOEL of 1.8 mg/kg/day from the 1-year feeding study in 
dogs which was the basis of the RfD.
    b. Post-natal sensitivity. In the reproductive toxicity study in 
rats, the reproductive NOEL (12.1 mg/kg/day) is 14-fold higher than the 
parental NOEL (0.85 mg/kg/day) and indicates that post-natal toxicity 
in the reproductive studies occurs only in the presence of significant 
parental toxicity. These developmental and reproductive studies 
indicate that tebufenozide does not have additional post-natal 
sensitivity for infants and children in comparison to other exposed 
groups.
    2. Acute risk. Since no acute endpoint was identified for 
tebufenozide, no acute risk assessment is required.
    3. Chronic risk. Using the conservative exposure assumptions 
described above, HED has concluded that the percentage of the RfD that 
will be utilized by dietary (food only) exposure to residues of 
tebufenozide ranges from 41% for nursing infants (< 1 year old) up to 
80% for non-nursing

[[Page 26991]]

infants (< 1 year old). Despite the potential for exposure to 
tebufenozide in drinking water, HED does not expect the aggregate 
exposure (food and water) to exceed 100% of the RfD. Taking into 
account the completeness and reliability of the toxicity data and the 
conservative exposure assessment, HED 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

    The metabolism of tebufenozide in/on plants is adequately 
understood. The residue of concern is the parent compound, tebufenozide 
per se, as specified in 40 CFR 180.482.

B. Analytical Enforcement Methodology

    The Rohm and Haas Analytical Method TR 34-93-119 (HPLC/UV), should 
be adequate to determine residues of tebufenozide per se in/on peppers.

C. Magnitude of Residues

    Residues of tebufenozide per se are not expected to exceed 0.5 ppm 
in or on peppers as a result of this section 18 use.

D. International Residue Limits

    There are currently no CODEX, Canadian, or Mexican listings for 
tebufenozide residues, therefore there are no harmonization issues for 
this action.

VI. Conclusion

    Therefore, the tolerance is established for residues of 
tebufenozide in peppers (bell and non-bell) at 0.5 ppm.

VII. 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 July 14, 1998, 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 rulemaking. The 
objections submitted must specify the provisions of the regulation 
deemed objectionable and the grounds for the objections (40 CFR 
178.25). Each objection must be accompanied by the fee prescribed by 40 
CFR 180.33(i). 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.

VIII. Public Docket

    EPA has established a record for this rulemaking under docket 
control number [OPP-300640] (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, Crystal 
Mall #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 rulemaking, 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 rulemaking record which 
will also include all comments submitted directly in writing. The 
official rulemaking record is the paper record maintained at the 
Virginia address in ``ADDRESSES'' at the beginning of this document.

IX. Regulatory Assessment Requirements

    This final rule establishes a tolerance under FFDCA section 
408(l)(6). 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 prior consultation as 
specified by Executive Order 12875, entitled Enhancing the 
Intergovernmental Partnership (58 FR 58093, October 28, 1993), or 
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 these tolerances and exemptions that are 
established under FFDCA section 408 (l)(6), such as the tolerance in 
this final rule, do not require the issuance of a proposed rule, the 
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et 
seq.) do not apply. Nevertheless, the Agency 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

[[Page 26992]]

there is no adverse economic impact. The factual basis for the Agency's 
generic certification for tolerance acations published on May 4, 1981 
(46 FR 24950), and was provided to the Chief Counsel for Advocacy of 
the Small Business Administration.

X. Submission to Congress and the General Accounting Office

    Under 5 U.S.C. 801(a)(1)(A), as added by the Small Business 
Regulatory Enforcement Fairness Act of 1996, the Agency has submitted 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 General Accounting Office prior to publication of this rule in 
today's Federal Register. This 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: May 5, 1998.

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. 346a and 371.

    2. In Sec. 180.482, in paragraph (b) by revising the entry for 
``Peppers'' in the table to read as follows:

Sec. 180.482  Tebufenozide; tolerances for residues.

* * * * *
    (b) * * *

------------------------------------------------------------------------
                                                          Expiration/   
            Commodity              Parts per million    revocation date 
------------------------------------------------------------------------
                                                                        
*                *                *                *                *   
                                  *                *                    
Peppers.........................  0.5                 9/30/99           
                                                                        
*                *                *                *                *   
                                  *                *                    
------------------------------------------------------------------------

* * * * *

[FR Doc. 98-12718 Filed 5-14-98; 8:45 am]
BILLING CODE 6560-50-F
Tebufenozide; Pesticide Tolerances for Emergency Exemptions

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