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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: November 26, 1997 (Volume 62, Number 228)]
[Rules and Regulations]
[Page 62979-62986]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr26no97-10]
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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: 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-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:
deegan.dave@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
[[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:
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(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