[Federal Register Volume 62, Number 54 (Thursday, March 20, 1997)]
[Rules and Regulations]
[Pages 13337-13342]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-7062]
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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: [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 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:
[email protected].
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
[[Page 13338]]
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
[[Page 13339]]
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
[[Page 13340]]
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.
[[Page 13341]]
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) * * *
[[Page 13342]]
------------------------------------------------------------------------
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]
BILLING CODE 6560-50-F