[Federal Register Volume 62, Number 127 (Wednesday, July 2, 1997)]
[Rules and Regulations]
[Pages 35683-35689]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-17370]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-300500; FRL-5719-9]
RIN 2070-AB78


Tebufenozide; Pesticide Tolerances for Emergency Exemptions

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes time-limited tolerances for 
residues of the insecticide tebufenozide in or on the following raw 
agricultural commodities: apples; apple pomace; cottonseed, undelinted; 
cottonseed meal; cottonseed oil; cottonseed hulls, cotton gin 
byproducts; milk; meat, meat fat, and meat by-products of cattle, 
sheep, and goats; and horse meat in connection with EPA's granting of 
emergency exemptions under section 18 of the Federal Insecticide, 
Fungicide, and Rodenticide Act authorizing use of tebufenozide on 
apples in Pennsylvania, New Jersey, Virginia, West Virginia, Michigan 
and New York. This regulation establishes maximum permissible levels 
for residues of tebufenozide on the above raw agricultural commodities 
pursuant to section 408(l)(6) of the Federal Food, Drug and Cosmetic 
Act, as amended by the Food Quality Protection Act of 1996. These 
tolerances will expire and be revoked on June 30, 1998.

DATES: This regulation becomes effective July 2, 1997. Objections and 
requests for hearings must be received by EPA on or before September 2, 
1997.

ADDRESSES: Written objections and hearing requests, identified by the 
docket control number, [OPP-300500], 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-300500], must be submitted to: Public Information 
and Records Integrity Branch, Information Resources and Services 
Division (7506C), 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, CM #2, 
1921 Jefferson Davis Hwy., Arlington, VA.
    A copy of objections and hearing requests filed with the Hearing 
Clerk may also be submitted electronically by sending electronic mail 
(e-mail) to: [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 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-300500]. No Confidential Business Information (CBI) should 
be submitted through e-mail. Electronic copies of objections and 
hearing requests on this rule may be filed online at many Federal 
Depository Libraries.

FOR FURTHER INFORMATION CONTACT: By mail: Pat Cimino, Registration 
Division (7505W), Office of Pesticide Programs, Environmental 
Protection Agency, 401 M St., SW., Washington, DC 20460. Office 
location, telephone number, and e-mail: Sixth Floor, Crystal Station 
#1, 2800 Jefferson Davis Highway, Arlington, VA 22202. (703) 308-8328, 
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 tolerances for 
residues of the insecticide tebufenozide (benzoic acid, 3,5-dimethyl-1-
(1,1-dimethylethyl)-2-(4-ethylbenzoyl)hydrazide) in or on apples at 1.0 
part per million (ppm); apple pomace at 2.0 ppm; cottonseed, undelinted 
at 0.2 ppm; cottonseed meal at 0.5 ppm; cottonseed oil at 1.3 ppm; 
cottonseed hulls at 0.8 ppm; cotton gin byproducts at 4.0 ppm; milk at 
0.05

[[Page 35684]]

ppm; meat of cattle, sheep, goats, and horses at 0.02 ppm; fat of 
cattle, sheep, and goats at 0.10 ppm; meat by-products (except liver 
kidney) of cattle, sheep, and goats at 0.10 ppm; liver of cattle, 
sheep, and goats at 1.0 ppm; and kidney of cattle, sheep, and goats at 
0.02 ppm. These tolerances will expire and be revoked by EPA on June 
30, 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 FFDCA, 21 
U.S.C. 301 et seq., and the Federal Insecticide, Fungicide, and 
Rodenticide Act (FIFRA), 7 U.S.C. 136 et seq. Among other things, FQPA 
amends FFDCA to bring all EPA pesticide tolerance-setting activities 
under 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 Exemptions for Tebufenozide on Apples and FFDCA 
Tolerances

    Between February 13 and April 24, 1997, the New Jersey Department 
of Environmental Protection, Virginia Department of Agriculture and 
Consumer Affairs, New York Department of Environmental Conservation, 
and Pennsylvania, West Virginia, and Michigan Departments of 
Agriculture requested a specific exemption under FIFRA section 18 for 
the use of tebufenozide on apples to control tufted apple bud moth in 
PA, NJ, VA and WV and oblique banded leafroller in NY and MI. These 
pests are becoming increasingly resistant to registered pesticide 
alternatives and growers are experiencing both quality and yield losses 
from infestations. The registered alternative products do not provide 
control of these pests and lack of a viable alternative is responsible 
for growing levels of economic loss over the last several years. 
Growers will experience significant economic loss if these pests are 
not controlled. After having reviewed their submissions, EPA concurs 
that emergency conditions exist.
    Between March 18 and June 20, 1997, the Texas, South Carolina, 
Louisiana, Florida, Mississippi, Arkansas, Alabama, Georgia and New 
Mexico Departments of Agriculture requested a specific exemption under 
FIFRA Section 18 for the use of tebufenozide on cotton to control beet 
armyworm in cotton. This pest is resistant to control by currently 
registered products and growers have experienced significant economic 
losses from infestations of this pest. After having reviewed their 
submissions, EPA concurs that emergency conditions exist.
    As part of its assessment of these applications for emergency 
exemption, EPA assessed the potential risks presented by residues of 
tebufenozide on apples. In doing so, EPA considered the new safety 
standard in FFDCA section 408(b)(2), and EPA decided to grant the 
section 18 exemptions only after concluding that the necessary 
tolerance under FFDCA section 408(l)(6) would clearly be consistent 
with the new safety standard and with FIFRA section 18. These 
tolerances for tebufenozide will permit the marketing of apples treated 
in accordance with the provisions of the section 18 emergency 
exemptions. Consistent with the need to move quickly on the emergency 
exemptions and to ensure that the resulting food is safe and lawful, 
EPA is issuing these tolerances without notice and opportunity for 
public comment under section 408(e) as provided in section 408(l)(6). 
Although these tolerances will expire and be revoked by EPA on June 30, 
1998, under FFDCA section 408(l)(5), residues of tebufenozide not in 
excess of the amount specified in the tolerances remaining in or on 
apples, milk, meat, meat fat and meat by-products after that date will 
not be unlawful, provided the pesticide is applied during the term of, 
and in accordance with all the conditions of, the emergency exemptions. 
EPA will take action to revoke these tolerances earlier if any 
experience with, scientific data on, or other relevant information on 
this pesticide indicate that the residues are not safe.
    EPA has not made any decisions about whether tebufenozide meets the 
requirements for registration under FIFRA section 3 for use on apples 
or whether permanent tolerances for tebufenozide for apples would be 
appropriate. This action by EPA does not serve as a basis for 
registration of tebufenozide by a State for special local needs under 
FIFRA section 24(c). Nor does this action serve as the basis for any 
States other than Pennsylvania, New Jersey, Virginia, West Virginia, 
New York or Michigan to use this product on this crop under section 18 
of FIFRA without following all provisions of section 18 as identified 
in 40 CFR 180.166. For additional information regarding the emergency 
exemptions 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

[[Page 35685]]

adverse health effects, including (but not limited to) reproductive 
effects, developmental toxicity, toxicity to the nervous system, and 
carcinogenicity. For many of these studies, a dose-response 
relationship can be determined, which provides a dose that causes 
adverse effects (threshold effects) and doses causing no observed 
effects (the ``no-observed effect level'' or ``NOEL'').
    Once a study has been evaluated and the observed effects have been 
determined to be threshold effects, EPA generally divides the NOEL from 
the study with the lowest NOEL by an uncertainty factor (usually 100 or 
more) to determine the Reference Dose (RfD). The RfD is a level at or 
below which daily aggregate exposure over a lifetime will not pose 
appreciable risks to human health. An uncertainty factor (sometimes 
called a ``safety factor'') of 100 is commonly used since it is assumed 
that people may be up to 10 times more sensitive to pesticides than the 
test animals, and that one person or subgroup of the population (such 
as infants and children) could be up to 10 times more sensitive to a 
pesticide than another. In addition, EPA assesses the potential risks 
to infants and children based on the weight of the evidence of the 
toxicology studies and determines whether an additional uncertainty 
factor is warranted. Thus, an aggregate daily exposure to a pesticide 
residue at or below the RfD (expressed as 100% or less of the RfD) is 
generally considered acceptable by EPA. For shorter term risks, EPA 
calculates a 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 
relationships. 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.
    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. 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 reliable federal 
and private market basket survey data. Typically, a range of estimates 
are supplied and the upper end of this range is assumed for the 
exposure assessment. By using the upper end estimate of percent of crop 
treated, the Agency is reasonably certain that exposure is not 
understated for any significant subpopulation group.

IV. Aggregate Risk Assessments 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.

A. Toxicological Profile

    1. Acute toxicity. No acute toxicological effects of concern were 
identified by the Agency.
    2. Short- and intermediate-term toxicity. No short- or 
intermediate-term toxicological effects of concern were identified by 
the Agency.
    3. Chronic toxicity. The RfD for tebufenozide is 0.018 
milligrams(mg)/kilogram(kg)/day and is based on a 1-year feeding study 
in dogs with a NOEL of 1.8 mg/kg/day and an uncertainty factor of 100. 
Decreased red blood cells, hematocrit, and hemoglobin and increased 
heinz bodies, reticulocytes, and platelets were observed at the lowest-
observed effect level (LOEL) of 8.7 mg/kg/day.
    4. Cancer. Using its Guidelines for Carcinogen Risk Assessment 
published September 24, 1986 (51 FR 33992), the Agency has classified 
tebufenozide as a Group ``E'' chemical (no evidence of carcinogenicity) 
based on the results of carcinogenicity studies in two species. There 
was no evidence of carcinogenicity in a 2-year rat study and an 18-
month mouse study.

B. Aggregate Exposure

    In examining aggregate exposure, FQPA directs EPA to consider 
available information concerning exposures from the pesticide residue 
in food and all other non-occupational exposures. The primary non-food 
sources of exposure the Agency looks at include drinking water (whether 
from groundwater or surface water), and exposure through pesticide use 
in gardens, lawns, or buildings (residential and other indoor uses). In 
evaluating food exposures, EPA takes into account varying consumption 
patterns of major identifiable subgroups of consumers, including 
infants and children.
    A permanent tolerance of 0.1 ppm has been established for residues 
of tebufenozide in or on walnuts and an apple import tolerance has been 
established. Tebufenozide is not registered for indoor or outdoor 
residential uses.
    1. Acute exposure. 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. No acute toxicological effects of concern have been 
identified for tebufenozide and an acute risk assessment is not 
required.
    2. Chronic exposure.--i. Dietary-food exposure. In conducting 
exposure assessments for this section 18 request, EPA used tolerance 
level residues and assumed that 100% of the crop would be treated with 
the pesticide (TMRC worst-case analysis assumptions, as described 
above).
    ii. Drinking water exposure. Environmental fate data submitted to 
the Agency suggest that tebufenozide is moderately persistent to 
persistent and mobile and could potentially leach to groundwater and 
runoff to surface water under certain environmental conditions.
    No Maximum Concentration Level or Health Advisory Level has been 
established for residues of tebufenozide in drinking water. There is no 
entry for

[[Page 35686]]

tebufenozide in the ``Pesticides in Groundwater Database'' (EPA 34-12-
92-001, Sept. 1992).
    Because the Agency lacks sufficient water-related exposure data to 
complete a comprehensive drinking water risk assessment for many 
pesticides, EPA has commenced and nearly completed a process to 
identify a reasonable yet conservative bounding figure for the 
potential contribution of water related exposure to the aggregate risk 
posed by a pesticide. In developing the bounding figure, EPA estimated 
residue levels in water for a number of specific pesticides using 
various data sources. The Agency then applied the estimated residue 
levels, in conjunction with appropriate toxicological endpoints (RfD's 
or acute dietary NOEL's) and assumptions about body weight and 
consumption, to calculate, for each pesticide, the increment of 
aggregate risk contributed by consumption of contaminated water. While 
EPA has not yet pinpointed the appropriate bounding figure for 
consumption of 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.
    iii. Non-dietary, non-occupational exposure. Non-dietary, non-
occupational exposure is not expected because tebufenozide is not 
registered for indoor or outdoor residential uses.

C. 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.

D. Safety Determinations for U.S. Population

    1. Acute risk. No acute toxicological effects of concern have been 
identified for tebufenozide and an acute risk assessment is not 
required.

    2. Short- and intermediate-term risk. Because no toxicity concerns 
have been identified by the Agency for short- or intermediate-term 
exposure to tebufenozide and no indoor or outdoor residential uses are 
registered, a short- or intermediate-term aggregate risk assessment is 
not required.
    3. Chronic risk. Using the conservative TMRC exposure assumptions 
described above, EPA has concluded that chronic aggregate exposure to 
tebufenozide from food will utilize 31% of the RfD for the U.S. 
population. Aggregate exposure to tebufenozide from food utilizes <81% 
of the RfD for all major identifiable subgroups, including infants and 
children. 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, 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 from chronic aggregate 
exposure to tebufenozide residues.

E. Determination of Safety for Infants and Children

    In assessing the potential for additional sensitivity of infants 
and children to residues of tebufenozide, EPA considered data from 
developmental toxicity studies in the rat and rabbit and a two-
generation reproduction study in the rat. The developmental toxicity 
studies are designed to evaluate adverse effects on the developing 
organism resulting from 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

[[Page 35687]]

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.
    Based on current toxicological data requirements, the data base for 
developmental and reproductive studies for tebufenozide is complete. 
The data indicate that there are no special pre- or post-natal toxicity 
concerns for infants and children and that the standard uncertainty 
factor is adequate to protect the safety of infants and children.
    Developmental toxicity was not observed in developmental studies 
using rats and rabbits. The NOEL for developmental effects in both rats 
and rabbits was 1,000 mg/kg/day (HDT), which is the limit dose for 
testing in developmental studies.
    1. Developmental toxicity studies.--i. Rat developmental toxicity. 
The maternal (systemic) NOEL was 250 mg/kg/day and the LOEL was 1,000 
mg/kg/day based on decreased weight gain and food consumption. The 
developmental (pup) NOEL was >1,000 mg/kg/day, the highest dose tested 
(HDT).
    ii. Rabbit developmental toxicity. The maternal (systemic) and 
developmental (pup) NOELs were >1,000 mg/kg/day (HDT).
    2. Reproductive toxicity studies.--Rat reproduction toxicity. In 
the two-generation reproductive toxicity study in the rat, the parental 
(systemic) NOEL was 0.85 mg/kg/day. Splenic pigmentation changes and 
extramedullary hematopoiesis occurred in the parents at the LOEL of 
12.1 mg/kg/day (in males and females and in both generations). In 
addition to these effects, decreased body weight gain and food 
consumption occurred at 171.1 mg/kg/day.
    The reproductive (pup) NOEL was 12.1 mg/kg/day and the LOEL was 
171.1 mg/kg/day based on a slight increase, in both generations, in the 
number of pregnant females that did not deliver and a slight increase 
in the number of second generation pregnant females that had difficulty 
delivering and had to be sacrificed. Additionally, in second generation 
dams at the LOEL, 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 first 
generation and on LD's 0 and 4 (80%) for the second generation. Because 
these reproductive effects occurred in the presence of parental 
(systemic) toxicity, these data do not suggest an increased post-natal 
sensitivity to children and infants (that infants and children might be 
more sensitive than adults) to tebufenozide exposure.
    3. Pre- and post- natal sensitivity. The developmental (pup) NOELs 
of >1,000 mg/kg/day (HDT) from the rat and rabbit developmental 
toxicity studies demonstrate that there is no developmental (pre-natal) 
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.
    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 sensitivity for infants and 
children in comparison to other exposed groups.
    4. Acute risk. No acute toxicological effects of concern have been 
identified for tebufenozide and an acute risk assessment is not 
required.
    5. Short- and intermediate-term risk. Because no toxicity concerns 
have been identified by the Agency for short- or intermediate-term 
exposure to tebufenozide and no indoor or outdoor residential uses are 
registered, a short- or intermediate-term aggregate risk assessment is 
not required.

    6. Chronic risk. Using the conservative exposure assumptions 
described above, EPA has concluded that the percentage of RfD that will 
be utilized by dietary (food only) exposure to residues of tebufenozide 
ranges from 41% for nursing infants 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 chronic exposure to 
tebufenozide in drinking water, 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 chronic aggregate exposure to tebufenozide residues.

V. Other Considerations

A. Metabolism in Plants and Animals

    The metabolism 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 in animals is not adequately understood; however, 
for purposes of these Section 18 exemptions only, the Agency considers 
the residue of concern to be the parent compound, tebufenozide per se. 
Estimates of secondary residues in ruminant tissues were extrapolated 
from data from a goat metabolism study submitted to support the import 
tolerance on apples. The recommended secondary ruminant tissue residues 
are based on high level dosing and maximum radioactive residues found 
in goat tissues and are likely conservative estimates of the actual 
residue levels that would occur in ruminants fed apple pomace 
containing tebufenozide residues.

B. Analytical Enforcement Methodology

    The HPLC/UV method, TR 34-94-38 is adequate to detect residue so 
the parent compound in apples. At this time, there are no analytical 
methods available to the Agency to detect secondary residues in animal 
matrixes as a result of this use.

C. Magnitude of Residues

    Residues of tebufenozide are not expected to exceed the following 
levels as a result of this use: 1.0 ppm in apples; 2.0 ppm in apple 
pomace; 0.05 ppm in milk; 0.02 ppm in meat of cattle, sheep, goat, and 
horse; 0.1 ppm in fat of cattle, sheep, and goats; 0.1 ppm in meat by-
products (except liver and kidney) of cattle, sheep, and goats; 1.0 ppm 
in liver of cattle, sheep, and goat; and 0.02 ppm in kidneys of cattle, 
sheep, and goats.

D. International Residue Limits

    There are no Codex, Canadian, or Mexican international residue 
limits established for use of tebufenozide on apples.

VI. Conclusion

    Therefore, tolerances in connection with the FIFRA section 18 
emergency exemptions are established for residues of tebufenozide in/on 
the following: apples - 1.0 ppm; apple pomace - 2.0 ppm; cottonseed, 
undelinted - 0.2 ppm; cottonseed meal - 0.5 ppm; cottonseed oil - 1.3 
ppm; cottonseed hulls - 0.8 ppm; cotton gin byproducts - 4.0 ppm; milk 
- 0.05 ppm; meat of cattle, sheep, goat, and horse - 0.02 ppm; fat of 
cattle, sheep, and goats - 0.1 ppm; meat by-products (except liver and 
kidney) of cattle, sheep, and goats - 0.1 ppm; liver of cattle, sheep, 
and goat - 1.0 ppm; and kidneys of cattle, sheep, and goats - 0.02 ppm.

[[Page 35688]]

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 September 2, 1997, file written objections to 
any aspect of this regulation (including the revocation provision) and 
may also request a hearing on those objections. Objections and hearing 
requests must be filed with the Hearing Clerk, at the address given 
above (40 CFR 178.20). A copy of the objections and/or hearing requests 
filed with the Hearing Clerk should be submitted to the OPP docket for 
this rulemaking. The objections submitted must specify the provisions 
of the regulation deemed objectionable and the grounds for the 
objections (40 CFR 178.25). Each objection must be accompanied by the 
fee prescribed by 40 CFR 180.33(i). If a hearing is requested, the 
objections must include a statement of the factual issues on which a 
hearing is requested, the requestor's contentions on such issues, and a 
summary of any evidence relied upon by the requestor (40 CFR 178.27). A 
request for a hearing will be granted if the Administrator determines 
that the material submitted shows the following: There is genuine and 
substantial issue of fact; there is a reasonable possibility that 
available evidence identified by the requestor would, if established, 
resolve one or more of such issues in favor of the requestor, taking 
into account uncontested claims or facts to the contrary; and 
resolution of the factual issues in the manner sought by the requestor 
would be adequate to justify the action requested (40 CFR 178.32). 
Information submitted in connection with an objection or hearing 
request may be claimed confidential by marking any part or all of that 
information as 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 Docket

    EPA has established a record for this rulemaking under docket 
control number [OPP-300500] (including any comments and data submitted 
electronically). A public version of this record, which does not 
include any information claimed as CBI, is available for inspection 
from 8 a.m. to 4:30 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 (7506C), Office of Pesticide Programs, Environmental 
Protection Agency, Crystal Mall #2, 1921 Jefferson Davis Highway, 
Arlington, VA.
    Electronic comments may be sent diectly to EPA:
[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 section 408 of the 
FFDCA and is in response to a petition received by the Agency 
requesting the establishment of such a tolerance. 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). In addition, 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, because tolerances that are established on the basis 
of a petition under section 408(d) of FFDCA, such as the tolerance in 
this final rule, do not require the issuance of a proposed rwule, the 
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et 
seq.) do not apply. Prior to the recent amendments to the FFDCA, 
however, EPA had treated such actions as subject to the RFA. The 
amendments to the FFDCA clarify that no proposed rule is required for 
such regulatory actions, which makes the RFA inapplicable to these 
actions. 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 (46 FR 24950, May 4, 1981). In accordance with Small Business 
Administration (SBA) policy, this determination will be provided to the 
Chief Counsel for Advocacy of the SBA upon request.

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 ofRepresentatives, 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: June 13, 1997.

James Jones,
Acting Director, Registration Division, Office of Pesticide Programs.
    Therefore, 40 CFR Chapter I is amended as follows:

[[Page 35689]]

PART 180--[AMENDED]

    1. The authority citation for part 180 continues to read as 
follows:
    Authority: 21 U.S.C. 346a and 371.
    2. Section 180.482 is amended as follows:
    a. In paragraph (a) by adding a heading.
    b. In paragraph (b) by revising the introductory text and 
alphabetically adding the entries to the table.
    c. By adding the headings and reserving new paragraphs (c) and (d).


Sec. 180.482  Tebufenozide; tolerances for residues.

    (a) General. *    *    *
    (b) Section 18 emergency exemptions. Time-limited tolerances are 
established for residues of the insecticide benzoic acid in connection 
with use of the pesticide under section 18 emergency exemptions granted 
by EPA. The tolerances will expire and are revoked on the dates 
specified in the following table.

----------------------------------------------------------------------------------------------------------------
                                                                                          Expiration/Revocation 
                           Commodity                               Parts per million               Date         
----------------------------------------------------------------------------------------------------------------
Apple pomace..................................................                      2.0                  6/30/98
Apples........................................................                      1.0                  6/30/98
Cattle, fat...................................................                     0.10                  6/30/98
Cattle, kidney................................................                     0.02                  6/30/98
Cattle, liver.................................................                      1.0                  6/30/98
Cattle, mbyp..................................................                     0.10                  6/30/98
Cattle, meat..................................................                     0.02                  6/30/98
Cotton gin byproducts.........................................                      4.0                  6/30/98
Cottonseed hulls..............................................                      0.8                  6/30/98
Cottonseed meal...............................................                      0.5                  6/30/98
Cottonseed oil................................................                      1.3                  6/30/98
Cottonseed, undelinted........................................                      0.2                  6/30/98
Goats, fat....................................................                     0.10                  6/30/98
Goats, kidney.................................................                     0.02                  6/30/98
Goats, liver..................................................                      1.0                  6/30/98
Goats, mbyp...................................................                     0.10                  6/30/98
Goats, meat...................................................                     0.02                  6/30/98
Horses, meat..................................................                     0.02                  6/30/98
                                                                                                                
*                    *                    *                    *                    *                    *      
                                                              *                                                 
Milk..........................................................                     0.05                  6/30/98
                                                                                                                
*                    *                    *                    *                    *                    *      
                                                              *                                                 
Sheep, fat....................................................                     0.10                  6/30/98
Sheep, kidney.................................................                     0.02                  6/30/98
Sheep, liver..................................................                      1.0                  6/30/98
Sheep, mbyp...................................................                     0.10                  6/30/98
Sheep, meat...................................................                     0.02                  6/30/98
                                                                                                                
*                    *                    *                    *                    *                    *      
                                                              *                                                 
----------------------------------------------------------------------------------------------------------------

    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. [Reserved]
[FR Doc. 97-17370 Filed 7-1-97; 8:45 am]
BILLING CODE 6560-50-F