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Tebufenozide - Pesticide Tolerances for Emergency Exemptions for Sugarbeets 3/97

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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-300461; FRL-5595-3]
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 time-limited tolerances for residues of
the insecticide tebufenozide in or on the raw agricultural commodities sugar
beet roots, sugar beet tops, sugar beet molasses, sugar beet refined sugar and
sugar beet dried pulp 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 sugar beets in California.
This regulation establishes maximum permissible levels for residues of
tebufenozide on sugar beets. These tolerances will expire on March 30, 1998.
DATES: This regulation becomes effective March 20, 1997. This entries in the
table expire on March 30, 1998. Objections and requests for hearings must be
received by EPA on May 19, 1997.

ADDRESSES: Written objections and hearing requests, identified by the docket
control number, [OPP-300461], 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 document control number, [OPP-300461], 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: 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 file format or ASCII file format. All copies of
objections and hearing requests in electronic form must be identified by the
docket number [OPP-300461]. 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), 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: cimino.pat@epamail.epa.gov.

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 tolerances for residues of the insecticide tebufenozide (benzoic
acid, 3,5-dimethyl-1-(1,1-dimethylethyl)-2-(4- ethylbenzoyl)hydrazide) in or
on sugar beet roots at 0.3 parts per million (ppm), sugar beet tops at 0.6
ppm, sugar beet dried pulp at 6.0 ppm, and sugar beet molasses and refined
sugar at 4.0 ppm. These tolerances will expire by EPA on March 30, 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 FFDCA 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 FFDCA 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." FFDCA 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 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.

FFDCA 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.

FFDCA section 408(l)(6) also requires EPA to promulgate regulations by August
3, 1997, governing the establishment of tolerances and exemptions under FFDCA
section 408(l)(6) and requires that the regulations be consistent with FFDCA
section 408(b)(2) and (c)(2) and FIFRA section 18.

FFDCA 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 FFFDCA section 408(e) and
(l)(6) without notice and comment rulemaking.

In establishing FIFRA section 18-related tolerances and exemptions during this
interim period before EPA issues the FFDCA section 408(l)(6) procedural
regulation and before EPA makes its broad policy decisions concerning the
interpretation and implementation of the new FFDCA section 408, EPA does not
intend to set precedents for the application of FFDCA section 408 and the new
safety standard to other tolerances and exemptions. Rather, these early FIFRA
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 FIFRA section 18-related tolerances and
exemptions that clearly qualify under the new law.

II. Emergency Exemptions for Tebufenozide on Sugar Beets and FFDCA Tolerances

On October 11, 1996, the California Environmental Protection Agency,
Department of Pesticide Regulation requested a specific exemption under FIFRA
section 18 for the use of tebufenozide to control Granulate Cutworm (Agrotis
subterranea) on sugar beets. Sugar beets grown in Imperial County, California
are severely infested with granulate cutworms and growers have already
experienced economic loss from this pest. The registered alternative products
do not provide control of this pest and lack of a viable alternative is
responsible for acreage loss over the last several years. Growers will
experience significant economic loss if the pest is not controlled. After
having reviewed their submission, EPA concurs that an emergency condition
exists.

As part of its assessment of these applications for emergency exemption, EPA
assessed the potential risks presented by residues of tebufenozide on sugar
beets. In doing so, EPA considered the new safety standard in FFDCA section
408(b)(2), and EPA decided to grant the FIFRA 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 sugar beets
treated in accordance with the provisions of the FIFRA 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 this tolerance without notice and opportunity for public comment under
FFDCA section 408(e) as provided in FFDCA section 408(l)(6). Although these
tolerances will expire and be revoked by EPA on March 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 sugar beets 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 this tolerance 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 sugar beets or
whether permanent tolerances for tebufenozide for sugar beets 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 California to use
this product on this crop under section 18 of FIFRA without following all
provisions of FIFRA 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 a reasonable certainty of no harm.

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 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 Assessment and Determination of Safety

Consistent with FFDCA 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. EPA has sufficient data to assess the hazards of tebufenozide and to
make a determination on aggregate exposure, consistent with FFDCA section
408(b)(2), for the time-limited tolerances for residues of tebufenozide in or
on sugar beet roots at 0.3 ppm, sugar beet tops at 0.6 ppm, sugar beet dried
pulp at 6.0 ppm, and sugar beet molasses and refined sugar at 4.0 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) 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.
Tolerances currently exist for residues on apples and walnuts (see 40 CFR
180.482).

For purposes of assessing the potential dietary exposure under this tolerance,
EPA assumed tolerance level residues and 100 percent of crop treated to
estimate the TMRC from all established food uses for tebufenozide (walnuts and
import tolerances for apples) as well as other recently granted emergency
exemption uses (peppers) and the proposed use on sugar beets. There are sugar
beet animal feed items. However, the residue levels in animal commodities
potentially resulting from feeding of these commodities would most likely be
undetectable. For purposes of the FIFRA section 18 emergency exemption only,
the Agency is not recommending establishment of time-limited tolerances for
tebufenozide on animal commodities.

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).

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 is no established Maximum Concentration Level
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).

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. A more detailed
description of this analysis is included in the docket for this rulemaking.
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 well below the level that would cause tebufenozide to exceed
the RfD if the tolerances 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 tolerances
are granted.

C. Cumulative Exposure to Substances with Common Mechanism of Toxicity

FFDCA 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

Based on the completeness and reliability of the toxicity data and the
conservative TMRC dietary exposure assumptions, EPA has concluded that dietary
exposure from food to tebufenozide will utilize 11.9 percent 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. Whatever reasonable bounding figure the Agency
eventually decides upon for the contribution from water, that number is
expected to be well below 88.1% 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 2-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.

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.

In the two-generation reproductive toxicity study in the rat, the
reproductive/developmental toxicity NOEL of 12.1 mg/kg/day was fourteenfold
higher than the parental (systemic) toxicity NOEL (0.85 mg/kg/day). The
reproductive (pup) LOEL of 171.1 mg/kg/day was based on a slight increase in
both generations in the number of pregnant females that either did not deliver
or had difficulty and had to be sacrificed. In addition, the length of
gestation increased and implantation sites decreased significantly in F1 dams.
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.

FFDCA section 408 provides that EPA shall apply an additional tenfold margin
of exposure (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 exposure (safety)
will be safe for infants and children. Margins of exposure (safety) are often
referred to as uncertainty (safety) factors. EPA believes that reliable data
support using the standard margin of exposure (usually 100x for combined
inter- and intra-species variability) and not the additional tenfold margin of
exposure 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 margin of exposure. Based on current toxicological data
requirements, the database for tebufenozide relative to pre- (provided by rat
and rabbit developmental studies) and post-natal (provided by the rat
reproduction study) toxicity is complete. The additional uncertainty factor is
not needed to protect the safety of infants and children.

Based on TMRC exposure estimates for food, as described above, EPA has
concluded that the percentage of the RfD that will be utilized by dietary
exposure to residues of tebufenozide ranges from 18.8 percent for children 7
to 12 years old, up to 53.3 percent for non-nursing infants (the most highly
exposed population subgroup). 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.

V. Other Considerations

The metabolism of tebufenozide in plants is adequately understood for the
purposes of this tolerance. There is no Codex maximum residue level
established for residues of tebufenozide on sugar beets. 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 the Food and Drug Administration. 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 in or on sugar beet
roots at 0.3 ppm, sugar beet tops at 0.6 ppm, dried pulp at 6.0 ppm, and
molasses and refined sugar at 4.0 ppm. These tolerances will expire and be
revoked on March 30, 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 FFDCA 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 19, 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-
300461]. A public version of this record, 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 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.

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
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 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: March 11, 1997.

Stephen L. Johnson,

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(b), by adding alphabetically the following entries to the
table:

Sec. 180.482 Tebufenozide; tolerances for residues.

* * * * *
(b) * * *

------------------------------------------------------------------------
                             Parts per
Commodity                    million         Expiration/Revocation Date
------------------------------------------------------------------------

Sugar beet, tops............. 0.6                 March 30, 1998
Sugar beet, roots............ 0.3                 March 30, 1998
Sugar beet, dried pulp....... 6.0                 March 30, 1998
Sugar beet, molasses......... 4.0                 March 30, 1998
Sugar beet, refined sugar.... 4.0                 March 30, 1998
------------------------------------------------------------------------

[FR Doc. 97-7062 Filed 3-19-97; 8:45 am]