[Federal Register Volume 62, Number 43 (Wednesday, March 5, 1997)]
[Rules and Regulations]
[Pages 9984-9989]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-5414]


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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180

[OPP-300456; FRL-5591-7]

RIN 2070-AC78


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 
combined residues of the insecticide tebufenozide in or on the raw 
agricultural commodities peppers, non-brassica leafy vegetables (Crop 
Group 4 - celery, lettuce, spinach, swiss chard), turnips grown for 
foliage tops only, and brassica (cole) leafy vegetables (Crop Group 5 - 
broccoli, cabbage, cauliflower, collards, kale, kohlrabi, and mustard 
greens) 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 peppers, leafy vegetables (except 
brassica), turnips grown for foliage tops only and brassica leafy 
vegetables in Texas; and lettuce, broccoli, cauliflower, cabbage and 
spinach in Arizona. This regulation establishes maximum permissible 
levels for residues of tebufenozide in these foods. These tolerances 
will expire on February 28, 1998.
DATES: This regulation becomes effective March 5, 1997. This regulation 
expires on February 28, 1998. Objections and requests for hearings must 
be received by EPA on May 5, 1997.

ADDRESSES: Written objections and hearing requests, identified by the 
docket control number, [OPP-300456], 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-300456], should be submitted to: Public Response 
and Program Resources Branch, Field Operations 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 Highway., 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: <a href="/cdn-cgi/l/email-protection#86e9f6f6abe2e9e5ede3f2c6e3f6e7ebe7efeaa8e3f6e7a8e1e9f0"><span class="__cf_email__" data-cfemail="fc938c8cd198939f979988bc998c9d919d9590d2998c9dd29b938a">[email protected]</span></a>.
    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 number [OPP-300456]. 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 address: Sixth Floor, Crystal 
Station #1, 2800 Jefferson Davis Highway, Arlington, VA 22202. (703) 
308-8328, e-mail: <a href="/cdn-cgi/l/email-protection#05666c686c6b6a2b7564714560756468646c692b6075642b626a73"><span class="__cf_email__" data-cfemail="e6858f8b8f8889c8968792a68396878b878f8ac8839687c8818990">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION: EPA, pursuant to section 408(e) and (l)(6) 
of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a(e) 
and (l)(6), is establishing a tolerance for residues of the insecticide 
tebufenozide (benzoic acid, 3,5-dimethyl-1-(1,1-dimethylethyl)-2-(4-
ethylbenzoyl)hydrazide) in or on peppers at 0.5 part per million (ppm), 
leafy vegetables (except brassica) at 5.0 ppm, turnip tops at 5.0 ppm, 
and brassica (cole) leafy vegetables at 5.0 ppm. These tolerances will 
expire on February 28, 1998.

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. 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 were 
discussed in detail in the final rule establishing the time-limited 
tolerance for an emergency exemption for use of propiconazole on 
sorghum (61 CFR 58135, November 13, 1996)(FRL-5572-9).
    New section 408(b)(2)(A)(i) 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, 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) 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. Section 408(l)(6) also requires EPA to promulgate regulations 
by August 3, 1997, governing the establishment of tolerances and 
exemptions under section 408(l)(6) and requires that the

[[Page 9985]]

regulations be consistent with section 408(b)(2) and (c)(2) and FIFRA 
section 18.
    Section 408(l)(6) allows EPA to establish tolerances or exemptions 
from the requirement for a tolerance, in connection with EPA's granting 
of FIFRA section 18 emergency exemptions, without providing notice or a 
period for public comment. Thus, consistent with the need to act 
expeditiously on requests for emergency exemptions under FIFRA, EPA can 
establish such tolerances or exemptions under the authority of section 
408(e) and (l)(6) without notice and comment rulemaking.
    In establishing section 18-related tolerances and exemptions during 
this interim period before EPA issues the section 408(l)(6) procedural 
regulation and before EPA makes its broad policy decisions concerning 
the interpretation and implementation of the new section 408, EPA does 
not intend to set precedents for the application of section 408 and the 
new safety standard to other tolerances and exemptions. Rather, these 
early section 18 tolerance and exemption decisions will be made on a 
case-by-case basis and will not bind EPA as it proceeds with further 
rulemaking and policy development. EPA intends to act on section 18-
related tolerances and exemptions that clearly qualify under the new 
law.

II. Emergency Exemptions for Tebufenozide on Peppers, Leafy 
Vegetables (except Brassica), Turnip Tops, and Cole Leafy 
Vegetables (Brassica) and FFDCA Tolerances

    On December 18, and 20, 1996, the Texas Department of Agriculture 
availed of itself the authority to declare the existence of a crisis 
situation within the State, thereby authorizing use under FIFRA section 
18 of tebufenozide on leafy vegetables (non-brassica), turnip tops and 
brassica leafy vegetables to control the beet armyworm (BAW), 
respectively. The states of Texas and Arizona have also requested 
specific exemptions for use of this chemical to control beet armyworm 
on brassica and non-brassica leafy vegetable, turnip tops and peppers. 
Emergency conditions are determined to exist due to: (1) The BAW 
populations demonstrating resistance to registered insecticides causing 
control failures when these products are applied to BAW; (2) a mild 
winter and unusually dry, hot weather have increased the survival rate 
of the pest. Natural controls, such as disease, needed cooler, wetter 
conditions to have their greatest impact on this pest; and (3) the 
unusually large numbers of BAW. According to the Applicant, estimated 
yield losses due to BAW in peppers and non-brassica leafy vegetables 
could result in a 50% yield loss and a 30% yield for brassica (cole) 
leafy vegetables without the use of an effective pesticide.
    As part of its assessment of these applications for emergency 
exemption, EPA assessed the potential risks presented by residues of 
tebufenozide on brassica (cole), non-brassica leafy vegetables, turnip 
tops and peppers. 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. This tolerance for tebufenozide 
will permit the marketing of brassica (cole) and non-brassica leafy 
vegetables, turnip tops and peppers 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 
on February 28, 1998, under FFDCA section 408(l)(5), residues of 
tebufenozide not in excess of the amount specified in the tolerance 
remaining in or on brassica (cole) , and non-brassica leafy vegetables, 
turnip tops and peppers 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 brassica 
(cole) and non-brassica leafy vegetables, turnip tops and peppers or 
whether a permanent tolerance for tebufenozide on these crops 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 
State other than Texas or Arkansas 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 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 percent or less of the 
RfD) is generally considered by EPA to pose no appreciable risk.
    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 margin of exposure calculation based on the 
appropriate

[[Page 9986]]

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, and other non-
occupational exposures, such as where residues leach into groundwater 
or surface water that is consumed as drinking water. 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 percent 
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.

IV. Aggregate Risk Assessments, Cumulative Risk Discussion, 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. Tebufenozide is not registered by EPA for indoor or 
outdoor residential use. Existing food and feed use tolerances for 
tebufenozide are listed in 40 CFR 180.482. At this time EPA is not in 
possession of a registration application for tebufenozide on brassica 
(cole) and non-brassica leafy vegetables, turnip tops, and peppers. 
However, based on the information submitted to the Agency thus far, 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 the time-limited tolerances for residues of tebufenozide on 
brassica (cole) leafy vegetables at 5.0 ppm, non-brassica leafy 
vegetables at 5.0 ppm, turnip tops at 5.0 ppm and peppers at 0.5 ppm. 
EPA's assessment of the dietary exposures and risks associated with 
establishing these tolerances follows.

A. Toxicological Profile

    1. Chronic toxicity. Based on the available chronic toxicity data, 
the EPA's Office of Pesticide Programs (OPP) has established the RfD 
for tebufenozide at 0.018 milligrams/kilogram/day (mg/kg/day). The RfD 
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.
    2. Acute toxicity. No appropriate acute dietary endpoint was 
identified by OPP. This risk assessment is not required.
    3. Carcinogenicity. Using its Guidelines for Carcinogen Risk 
Assessment published September 24, 1986 (51 FR 33992), OPP has 
classified tebufenozide as a Group ``E'' chemical (no evidence of 
carcinogenicity for humans) 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

    Tolerances for residues of tebufenozide are currently expressed as 
benzoic acid, 3,5-dimethyl-1-(1,1-dimethylethyl)-2-(4-
ethylbenzoyl)hydrazide. Permanent tolerances currently exist for 
residues on apples and walnuts (see 40 CFR 180.482).
    For purposes of assessing the chronic dietary exposure from 
tebufenozide, EPA assumed tolerance level residues and 100 percent of 
crop treated refinements to estimate the TMRC from all established 
existing food uses for tebufenozide as well as the proposed use on 
leafy vegetables, turnip tops and peppers. Neither peppers nor any of 
the commodities comprising Crop Group 4 (Non-brassica leafy vegetables) 
and 5 (Brassica Cole Leafy vegetables) are considered livestock feed 
items; thus, there is no reasonable expectation that measurable 
residues of tebufenozide will occur in meat, milk, poultry, or eggs 
under the terms of these emergency exemptions. Although, turnip tops 
potentially are a ruminant feed item, conversation with the Texas 
Department of Agriculture indicates that the turnip tops treated under 
this section 18 are destined for fresh market use only. Nonetheless, 
even if those turnip tops were fed to ruminants, potential residue 
levels in animal commodities would most likely be undetectable. For 
purposes of this section 18 registration only, OPP concludes that 
tolerances for animal commodities are not needed.
    Other potential sources of exposure of the general population to 
residues of pesticides are residues in drinking water and exposure from 
non-occupational sources. Based on the available studies used in EPA's 
assessment of environmental risk, tebufenozide is moderately persistent 
to persistent and mobile, and could potentially leach to groundwater 
and runoff to surface water under certain environmental conditions. 
There are no established Maximum Concentration Levels for residues of 
tebufenozide in drinking water. No drinking water health advisory 
levels have been established for tebufenozide. There is no entry for 
tebufenozide in the ``Pesticides in Groundwater Database'' (EPA 734-12-
92-001, September 1992).
    The Agency does not have available data to perform a quantitative 
drinking water risk assessment for tebufenozide at this time. However, 
in order to mitigate the potential for tebufenozide to leach into 
groundwater or runoff to surface water, precautionary language has been 
incorporated into the product label.
    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

[[Page 9987]]

as a conservation upper bound, would not prevent the Agency from 
determining that there is a reasonable certainty of no harm if the 
tolerance is granted.
    Tebufenozide is not registered for either indoor or outdoor 
residential use. Non-occupational exposure to the general population is 
therefore not expected and not considered in aggregate exposure 
estimates.

C. Cumulative Exposure to Substances with Common Mechanisms 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 policies and methodologies for 
conducting cumulative risk assessments. While 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 
methodology to fully resolve the 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 enable the Agency to apply common mechanism 
issues to its pesticide risk assessments. At present, however, the 
Agency does not know how to apply the information in its files 
concerning common mechanism issues to most risk assessments.
    In making individual tolerance decisions, the Agency will determine 
whether:
    1. It has sufficient information to determine that a pesticide does 
not appear to share a common mechanism of toxicity with other 
substances.
    2. It is unable to conclude that a pesticide does not share a 
common mechanism of toxicity with other substances.
    For pesticides falling into the first category, the Agency will 
explain its determination and factor the determination into the 
tolerance decision. For pesticides falling into the second category, 
the Agency will conclude that it does not have sufficient available 
information concerning common mechanism of toxicity to scientifically 
apply that information to the tolerance decision, the tolerance 
decision will be reached based upon the best available and useful 
information for the individual chemical, and a risk assessment will be 
performed for the individual chemical assuming that no common mechanism 
of toxicity exists. However, tolerance decisions falling into the 
second category will be reexamined by the Agency after EPA establishes 
methodologies and procedures for integrating information concerning 
common mechanism into its risk assessments. In such circumstances, 
related registration actions may be conditioned upon the provision of 
such data as may be necessary to evaluate common mechanism of toxicity 
issues in a risk assessment.
    Tebufenozide falls into the second category and at this time, the 
Agency has not made a determination that tebufenozide and other 
substances that may have a common mode of toxicity would have 
cumulative effects. EPA has not yet determined whether to include this 
chemical in a cumulative risk assessment. This tolerance determination 
does not take into account common mechanism issues. The Agency will 
reexamine tolerances for tebufenozide, after the Agency has developed a 
methodology for applying common mechanism of toxicity issues to risk 
assessments.
    Given the time limited nature of this request, the need to make 
emergency exemption decisions quickly, and the significant scientific 
uncertainty at this time about how to define common mode of toxicity, 
the Agency will make its safety determination for these tolerances 
based on those factors which it can reasonably integrate into a risk 
assessment. For purposes of these tolerances only, the Agency is 
considering only the potential risks of tebufenozide in its aggregate 
exposure.

D. Safety Determinations for U.S. Population

    EPA has concluded that chronic dietary exposure to tebufenozide 
will utilize 27% of the RfD for the U.S. population. EPA generally has 
no concern for exposures below 100 percent 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 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 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.
    Developmental (pre-natal) 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 the 
highest dose tested (HDT), which demonstrates that no toxicity was 
present for tebufenozide.
    In the two-generation reproductive toxicity study in the rat, the 
reproductive/developmental toxicity NOEL of 12.1 mg/kg/day was 14-fold 
higher than the parental (systemic) toxicity NOEL (0.85 mg/kg/day), 
which indicates that post-natal toxicity in the production studies 
occurs only in the presence of significant parental toxicity.
    These developmental and reproduction studies indicate that 
tebufenozide does not have additional sensitivity for infants and 
children in comparison to other exposed groups. The TMRC value for the 
most highly exposed infant and children subgroup (non-nursing infants 
<1 year old) occupies 61% of the RfD. However, this calculation assumes 
100% crop treated and uses tolerance level residues for all 
commodities. Refinement of the dietary risk assessment by using percent 
crop treated and anticipated residue data would greatly reduce dietary 
exposure. Therefore, this risk assessment is an over-estimate of 
dietary risk. Consideration of anticipated residues and percent crop 
treated would likely result in an anticipated residue contribution 
(ARC) which would occupy a percent of the RfD that is likely to be 
significantly lower than the currently calculated TMRC value. 
Therefore, taking into account the completeness and reliability of the 
toxicity data and the conservative exposure assessment, EPA concludes 
that there is a reasonable certainty that no harm will result to 
infants and children from aggregate exposure to tebufenozide residues.

[[Page 9988]]

    FFDCA section 408 provides that EPA shall apply an additional 
safety factor for infants and children in the case of threshold effects 
to account for pre- and post-natal toxicity and the completeness of the 
data base unless EPA concludes that a different margin of safety is 
appropriate. EPA has concluded that the database on this pesticide is 
sufficiently complete regarding potential effects on infants and 
children and that the studies demonstrate no additional sensitivity in 
infants and children. Therefore, EPA concludes that an additional 
uncertainty factor is not warranted and that the RfD at 0.018 mg/kg/day 
based on a 100-fold safety is adequate for protecting infants and 
children.

V. Other Considerations

    The metabolism of tebufenozide in plants is adequately understood 
for the purposes of this tolerance. There are no Mexican, Canadian or 
Codex International maximum residue levels established for residues of 
tebufenozide. There is a practical analytical method (liquid 
chromatography with ultraviolet detection) for detecting and measuring 
levels of tebufenozide in or on food with a limit of detection that 
allows monitoring of food with residues at or above the level set by 
the tebufenozide tolerance. EPA has provided information on this method 
to FDA. The method is available to anyone who is interested in 
pesticide residue enforcement from: By mail, Calvin Furlow, Public 
Response and Program Resources Branch, Field Operations Division 
(7506C), Office of Pesticide Programs, Environmental Protection Agency, 
401 M St., SW., Washington, DC 20460. Office location and telephone 
number: Crystal Mall #2, Rm 1128, 1921 Jefferson Davis Highway, 
Arlington, VA 22202, 703-305-5805.

VI. Conclusion

    Therefore, tolerances in connection with the FIFRA section 18 
emergency exemptions are established for residues of tebufenozide at 
0.5 ppm in peppers, 5.0 ppm in/on leafy vegetables (brassica and non-
brassica-cole), and 5.0 ppm in/on turnip tops grown for foliage tops 
only. These tolerances will expire on February 28, 1998.

 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 May 5, 1997, file written objections to any 
aspect of this regulation and may also request a hearing on those 
objections. Objections and hearing requests must be filed with the 
Hearing Clerk, at the address given above (40 CFR 178.20). A copy of 
the objections and/or hearing requests filed with the Hearing Clerk 
should be submitted to the OPP docket for this rulemaking. The 
objections submitted must specify the provisions of the regulation 
deemed objectionable and the grounds for the objections (40 CFR 
178.25). Each objection must be accompanied by the fee prescribed by 40 
CFR 180.33(i). If a hearing is requested, the objections must include a 
statement of the factual issues on which a hearing is requested, the 
requestor's contentions on such issues, and a summary of any evidence 
relied upon by the requestor (40 CFR 178.27). A request for a hearing 
will be granted if the Administrator determines that the material 
submitted shows the following: There is genuine and substantial issue 
of fact; there is a reasonable possibility that available evidence 
identified by the requestor would, if established, resolve one or more 
of such issues in favor of the requestor, taking into account 
uncontested claims or facts to the contrary; and resolution of the 
factual issues in the manner sought by the requestor would be adequate 
to justify the action requested (40 CFR 178.32). Information submitted 
in connection with an objection or hearing request may be claimed 
confidential by marking any part or all of that information as 
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

    A record has been established for this rulemaking under docket 
number [OPP-300456]. A public version of this record, which does not 
include any information claimed as CBI, is available for inspection 
from 8:30 am to 4 pm, Monday through Friday, excluding legal holidays. 
The public record is located in Room 1132 of the Public Response and 
Program Resources Branch, Field Operations Division (7506C), Office of 
Pesticide Programs, Environmental Protection Agency, Crystal Mall #2, 
1921 Jefferson Davis Highway, Arlington, VA.
    Electronic comments may be sent directly to EPA at:
    <a href="/cdn-cgi/l/email-protection#96f9e6e6bbf2f9f5fdf3e2d6f3e6f7fbf7fffab8f3e6f7b8f1f9e0"><span class="__cf_email__" data-cfemail="543b242479303b373f31201431243539353d387a3124357a333b22">[email protected]</span></a>.


    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, is kept in paper form. Accordingly, in the 
event there are objections and hearing requests, 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. 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

    Under Executive Order 12866 (58 FR 51735, October 4, 1993), this 
action is not a ``significant regulatory action'' and, since this 
action does not impose any information collection requirements as 
defined by the Paperwork Reduction Act, 44 U.S.C. 3501 et seq., it is 
not subject to review by the Office of Management and Budget. In 
addition, this action does not impose any enforceable duty or contain 
any unfunded mandate as described in the Unfunded Mandates Reform Act 
of 1995 (Pub. L. 104-4), or require prior consultation with State 
officials as specified by Executive Order 12875 (58 FR 58093, October 
28, 1993), or special considerations as required by Executive Order 
12898 (59 FR 7629, February 16, 1994).
    Because FFDCA section 408(l)(6) permits establishment of this 
regulation without a notice of proposed rulemaking, the regulatory 
flexibility analysis requirements of the Regulatory Flexibility Act, 5 
U.S.C. 604(a), do not apply.
    Under 5 U.S.C. 801(a)(1)(A) of the Administrative Procedure Act 
(APA) as amended by the Small Business Regulatory Enforcement Fairness 
Act of 1996 (Title II of Pub. L. 104-121, 110 Stat. 847), EPA submitted 
a report containing this rule and other required information to the 
U.S. Senate, the U.S. House of Representatives and the

[[Page 9989]]

Comptroller General of the General Accounting Office prior to 
publication of the rule in today's Federal Register. This rule is not a 
``major rule'' as defined by 5 U.S.C. 804(2) of the APA as amended.

List of Subjects in 40 CFR Part 180

    Environmental protection, Administrative practice and procedure, 
Agricultural commodities, Pesticides and pests, Reporting and record 
keeping requirements.
    Dated: February 25, 1997.

Peter Caulkins,

Acting Director, 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, the section heading and the table in paragraph 
(b) are revised to read as follows:


Sec. 180.482  Tebufenozide; tolerances for residues.

*      *     *     *     *
    (b) *    *    *

------------------------------------------------------------------------
                                     Parts per    Expiration/Revocation 
             Commodity                million              Date         
------------------------------------------------------------------------
Leafy Vegetable (Cole -brassica)..          5.0        February 28, 1998
Leafy Vegetables (non-brassica)...          5.0        February 28, 1998
Peppers...........................          0.5        February 28, 1998
Turnip Tops.......................          5.0        February 28, 1998
------------------------------------------------------------------------

[FR Doc. 97-5414 Filed 3-4-97; 8:45 am]
BILLING CODE 6560-50-F


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