Tebufenozide - Pesticide Tolerances for Emergency Exemptions for Vegetables 3/97
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.
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: email@example.com.
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
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: firstname.lastname@example.org. 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
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 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 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
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
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.
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
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.
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: email@example.com.
Electronic comments must be submitted as an ASCII file avoiding the use of special characters and any form of
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 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.
Acting Director, Office of Pesticide Programs.
Therefore, 40 CFR Chapter I is amended as follows:
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