[Federal Register Volume 62, Number 228 (Wednesday, November 26, 1997)]
[Rules and Regulations]
[Pages 62979-62986]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-31100]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-300569; FRL-5751-1]
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 sugarcane. 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 sugarcane. 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 be revoked on December 31, 1998.

DATES: This regulation is effective November 26, 1997. Objections and 
requests for hearings must be received by EPA on or before January 26, 
1998.

ADDRESSES: Written objections and hearing requests, identified by the 
docket control number, [OPP-300569], 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-300569], 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. 1132, Crystal 
Mall #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: [email protected].
    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-300569]. No 
Confidential Business Information (CBI) should be submitted through e-
mail. Electronic copies of objections and hearing request on this rule 
may be filed online at many Federal Depository Libraries.

FOR FURTHER INFORMATION CONTACT: By mail: David Deegan, Registration 
Division (7505C), Office of Pesticide Programs, Environmental 
Protection Agency, 401 M St., SW., Washington, DC 20460. Office 
location, telephone number, and e-mail address: CM #2, 1921 Jefferson 
Davis Hwy., Arlington, VA, (703) 308-9358, e-mail: 
[email protected].

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

[[Page 62980]]

a tolerance for residues of the insecticide tebufenozide, in or on 
sugarcane at 0.3 part per million (ppm). This tolerance will expire and 
be revoked on December 31, 1998. 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 (61 FR 58135, November 13, 1996)(FRL-5572-9).
    New section 408(b)(2)(A)(i) of the FFDCA allows EPA to establish a 
tolerance (the legal limit for a pesticide chemical residue in or on a 
food) only if EPA determines that the tolerance is ``safe.'' Section 
408(b)(2)(A)(ii) defines ``safe'' to mean that ``there is a reasonable 
certainty that no harm will result from aggregate exposure to the 
pesticide chemical residue, including all anticipated dietary exposures 
and all other exposures for which there is reliable information.'' This 
includes exposure through drinking water and in residential settings, 
but does not include occupational exposure. Section 408(b)(2)(C) 
requires EPA to give special consideration to exposure of infants and 
children to the pesticide chemical residue in establishing a tolerance 
and to ``ensure that there is a reasonable certainty that no harm will 
result to infants and children from aggregate exposure to the pesticide 
chemical residue. . . .''
    Section 18 of FIFRA authorizes EPA to exempt any Federal or State 
agency from any provision of FIFRA, if EPA determines that ``emergency 
conditions exist which require such exemption.'' This provision was not 
amended by FQPA. EPA has established regulations governing such 
emergency exemptions in 40 CFR part 166.
    Section 408(l)(6) of the FFDCA requires EPA to establish a time-
limited tolerance or exemption from the requirement for a tolerance for 
pesticide chemical residues in food that will result from the use of a 
pesticide under an emergency exemption granted by EPA under section 18 
of FIFRA. Such tolerances can be established without providing notice 
or period for public comment.
    Because decisions on section 18-related tolerances must proceed 
before EPA reaches closure on several policy issues relating to 
interpretation and implementation of the FQPA, EPA does not intend for 
its actions on such 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 Sugarcane and FFDCA 
Tolerances

    On March 27, 1997, EPA received a request from the Louisiana 
Department of Agriculture and Forestry, requesting that EPA authorize 
emergency use of tebufenozide (Confirm 2F Agricultural Insecticide, EPA 
Registration No. 707-238, registered by Rohm and Haas Co.) on sugarcane 
to control sugarcane borer, under provisions of section 18 of FIFRA. 
Louisiana's request for this pesticide use asserted that the population 
of sugarcane borer has chronically attained levels that can inflict 
significant damage to the sugarcane crop. In the past the preferred 
method of control had been with the chemical azinphos-methyl. However, 
due to large-scale fish kills which have resulted from use of azinphos-
methyl, EPA has restricted that chemical's use. Although Louisiana 
describes their efforts to develop an integrated pest management 
program to control sugarcane borer, they still require use of chemicals 
for this program to succeed. The state requested use of tebufenozide on 
up to 60,000 acres of sugarcane, at application rates of 0.12 lbs. 
active ingredient per acre, per application, with a maximum of two 
applications allowed during the use season of June 15 - September 15, 
1997. This use was also requested and authorized by EPA during the 
growing season of 1996. EPA allowed the Louisiana Department of 
Agriculture and Forestry to exercise its authority to authorize the use 
of tebufenozide on sugarcane for control of sugarcane borer in 
Louisiana under crisis provisions of section 18, described in 40 CFR 
166.40-160.53, on June 13, 1997.
    As part of its assessment of this emergency exemption, EPA assessed 
the potential risks presented by residues of tebufenozide in or on 
sugarcane. 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 be revoked on 
December 31, 1998, under FFDCA section 408(l)(5), residues of the 
pesticide not in excess of the amounts specified in the tolerance 
remaining in or on sugarcane after that date will not be unlawful, 
provided the pesticide is applied in a manner that was lawful under 
FIFRA. 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 sugarcane 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 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.

[[Page 62981]]

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 percent (%) 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 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 3 
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

[[Page 62982]]

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) 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 sugarcane at 0.3 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 
EPA, and is not of concern in this risk assessment.
    2.  Chronic toxicity. EPA has established the RfD for tebufenozide 
at 0.018 milligrams/kilogram/day (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 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).
    3. Carcinogenicity. Tebufenozide has been classified as a Group E, 
``no evidence of carcinogenicity for humans,'' chemical by EPA.

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. The residue of concern in sugarcane is 
the parent compound, tebufenozide per se, as specified in 40 CFR 
180.482. A permanent tolerance is established for the residues of 
tebufenozide in/on walnuts at 0.1 ppm and a time-limited tolerance in/
on peppers at 0.5 ppm. A permanent tolerance at 1.0 ppm has also 
previously been established for imported apples. EPA has recently taken 
actions to establish time-limited tolerances in connection with section 
18 uses on domestic apples (and time-limited tolerances on associated 
animal commodities), on 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, and turnip tops at 5.0 ppm. 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 EPA's 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:

                                                                        
------------------------------------------------------------------------
                                   TMRCfood (mg/kg/                     
       Population Subgroup               day)                %RfD       
------------------------------------------------------------------------
U.S. Population - 48 States.....  0.005516..........  31%               
Nursing Infants (<1 year old)...  0.007384..........  41%               
Non-Nursing Infants (<1 year      0.014348..........  80%               
 old).                                                                  
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: (1) the U.S. population (48 
States); (2) those for infants and children; and, (3) 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 RfDs.
    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

[[Page 62983]]

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 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. Chronic risk. Using the TMRC exposure assumptions described 
above, EPA has concluded that aggregate exposure to tebufenozide from 
food will utilize 31% of the RfD for the U.S. population. The major 
identifiable subgroup with the highest aggregate exposure is infants or 
children, which is discussed below. EPA generally has no concern for 
exposures below 100% of the RfD because the RfD represents the level at 
or below which daily aggregate dietary exposure over a lifetime will 
not pose appreciable risks to human health. Despite the potential for 
exposure to tebufenozide in drinking water and from non-dietary, non-
occupational exposure, EPA does not expect the aggregate exposure 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. EPA concludes that there is a reasonable certainty 
that no harm will result from aggregate exposure to tebufenozide 
residues.
    2. Short- and intermediate-term risk. Since there were no toxicity 
endpoints identified by the TES Committee 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. This is generally the case -- 
edit if different studies. The developmental toxicity studies are 
designed to evaluate adverse effects on the developing organism 
resulting from pesticide exposure during prenatal development to one or 
both parents. 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.

[[Page 62984]]

    ii. Developmental toxicity studies -- a. Rats. In the 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 the developmental toxicity study in rabbits, the 
maternal and developmental NOELs were >1,000 mg/kg/day (HDT).
    c. Pre-Natal Sensitivity. EPA has concluded that 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.
    iii. Reproductive toxicity study -- Rats. In the 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 (male, female; 
F0, F1). 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 (F1). Additionally at the LOEL, in F1 
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 
F1 and on LD's 0 and 4 to 80% for the second generation.
    iv. Pre- and 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. 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 infants (< 1 year old). EPA generally has no 
concern for exposures below 100% of the RfD because the RfD represents 
the level at or below which daily aggregate dietary exposure over a 
lifetime will not pose appreciable risks to human health. Despite the 
potential for exposure to tebufenozide in drinking water and from non-
dietary, non-occupational exposure, EPA does not expect the aggregate 
exposure to exceed 100% of the RfD. 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 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.
    The metabolism of tebufenozide in animals is not adequately 
understood. However, for the purpose of this section 18 exemption only, 
EPA considers the residue of concern to be the parent compound, 
tebufenozide per se.

B. Analytical Enforcement Methodology

    The HPLC/UV analytical method, TR 34-94-38 is adequate to detect 
residues of the parent compound in sugarcane to support this section 18 
request. There is also an available extraction and GC/MS confirmatory 
technique described in the Rohm and Haas rice metabolism study.
    There are no analytical methods available to the Agency, at this 
time, to detect secondary residues in animal matrices likely as a 
result of the proposed use.

C. Magnitude of Residues

    Residues of tebufenozide per se are not expected to exceed the 
following levels as a result of this section 18 use:

                                                                        
------------------------------------------------------------------------
                 Commodity                        Parts per million     
------------------------------------------------------------------------
sugarcane.................................  0.3                         
------------------------------------------------------------------------


    A time-limited tolerance for the residues of tebufenozide per se 
should be established at this level.
    The summation of a sugarcane processing study submitted with this 
action indicates that residues of tebufenozide do not concentrate in 
sugarcane refined sugar (0.03x) or molasses (1.1x). Thus, tolerances 
for the residues of tebufenozide per se are not needed on these 
commodities. However, the following levels were used for the DRES 
analysis which EPA performed:

                                                                        
------------------------------------------------------------------------
                 Commodity                        Parts per million     
------------------------------------------------------------------------
sugar, refined............................  0.01                        
sugar cane molasses.......................  0.35                        
------------------------------------------------------------------------


    Based on the summary data provided, residues of tebufenozide in 
ruminant commodities (cattle, sheep, horse, and goat) will not exceed 
the levels established for the use of tebufenozide on apples.
    There are no poultry or swine feed items associated with these 
uses; consequently secondary residues of tebufenozide are not expected 
in poultry or swine commodities.

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.

E. Rotational Crop Restrictions

    Sugarcane is not rotated to other crops, therefore a discussion of 
rotational crop restrictions is not germane to this action.

VI. Conclusion

    Therefore, the tolerance is established for residues of 
tebufenozide in sugarcane at 0.3 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 January 26, 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

[[Page 62985]]

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 Confidential Business Information 
(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 Record and Electronic Submissions

    EPA has established a record for this rulemaking under docket 
control number [OPP-300567] (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 Room 1132 of the Public Information and Records 
Integrity Branch, Information Resources and Services Division (7502C), 
Office of Pesticide Programs, Environmental Protection Agency, CM #2, 
1921 Jefferson Davis Hwy., Arlington, VA.
    Electronic comments may be sent directly to EPA at:
    [email protected].


    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(d) 
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) (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 on the basis of a petition under FFDCA section 408 (d), 
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 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: November 10, 1997.

James Jones,
Acting Director, Registration Division, Office of Pesticide Programs.

    Therefore, 40 CFR Chapter I is amended as follows:

PART 180 -- [AMENDED]

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

    Authority : 21 U.S.C. 346a and 371.


    2. In Sec. 180.482(b), by adding alphabetically the following entry 
to the table:


Sec.  180.482 Tebufenozide; tolerances for residues.

*      *      *      *      *
    (b)*      *      *

                                                                        
------------------------------------------------------------------------
                                                          Expiration/   
            Commodity              Parts per million    Revocation Date 
------------------------------------------------------------------------
                  *        *        *        *        *                 
Sugarcane.......................  0.03                December 31, 1998 
                  *        *        *        *        *                 
------------------------------------------------------------------------


[[Page 62986]]

*      *      *      *      *

[FR Doc. 97-31100 Filed 11-25-97; 8:45 am]
BILLING CODE 6560-50-F